,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois
0,32339447,"hIL-7-hyFc, A Long-Acting IL-7, Increased Absolute Lymphocyte Count in Healthy Subjects.","A low lymphocyte count puts immune-compromised patients at risk of mortality. hIL-7-hyFc is a homodimeric interleukin-7 (IL-7), a potent T-cell amplifier, fused to the hybridizing IgD/IgG4 immunoglobulin domain. We performed a randomized, double-blind, placebo-controlled, dose-escalation, phase I study to assess the pharmacokinetic, pharmacodynamic, safety, tolerability, and immunogenicity profiles of hIL-7-hyFc administered s.c. and i.m. to healthy volunteers. Thirty subjects randomly received hIL-7-hyFc or its matching placebo in an 8:2 ratio at 20, 60 μg/kg s.c., or 60 μg/kg i.m. The hIL-7-hyFc was slowly absorbed and its terminal half-life was 63.26 hours after i.m. administration. The hIL-7-hyFc increased absolute lymphocyte count, mostly in T-cells, which peaked 3 weeks after administration and then lasted for several additional weeks. The hIL-7-hyFc was well-tolerated after a single s.c. and i.m. administration. Injection site reaction was the most common treatment-emergent adverse event, which resolved spontaneously without treatment. The hIL-7-hyFc can be developed into a beneficial treatment option for patients with compromised T-cell immunity. This trial was registered at www.clinicaltrials.gov as #NCT02860715.",2020,"hIL-7-hyFc increased absolute lymphocyte count, mostly in T-cells, which peaked 3 weeks after administration and then lasted for several additional weeks.","['healthy volunteers', 'Thirty subjects randomly received', 'healthy subjects', 'patients with compromised T-cell immunity']","['hIL-7-hyFc or its matching placebo', 'hIL-7-hyFc administered subcutaneously (SC) and intramuscularly (IM', 'placebo']","['pharmacokinetic, pharmacodynamic, safety, tolerability and immunogenicity profiles', 'hIL-7-hyFc', 'absolute lymphocyte count']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3544087', 'cui_str': 'Absolute lymphocyte count'}]",30.0,0.207898,"hIL-7-hyFc increased absolute lymphocyte count, mostly in T-cells, which peaked 3 weeks after administration and then lasted for several additional weeks.","[{'ForeName': 'Sang Won', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea.'}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Choi', 'Affiliation': 'NeoImmuneTech, Inc., Rockville, Maryland, USA.'}, {'ForeName': 'MinKyu', 'Initials': 'M', 'LastName': 'Heo', 'Affiliation': 'Genexine, Inc., Seongnam-si, Gyeonggi-do, Korea.'}, {'ForeName': 'Eui-Cheol', 'Initials': 'EC', 'LastName': 'Shin', 'Affiliation': 'Graduate School of Medical Science and Engineering, Korea Advanced Institute of Science and Technology, Daejeon, Korea.'}, {'ForeName': 'Su-Hyung', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Graduate School of Medical Science and Engineering, Korea Advanced Institute of Science and Technology, Daejeon, Korea.'}, {'ForeName': 'So Jeong', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Biomedical Science and Engineering Interdisciplinary Program, Korea Advanced Institute of Science and Technology, Daejeon, Korea.'}, {'ForeName': 'Yeon-Kyung', 'Initials': 'YK', 'LastName': 'Oh', 'Affiliation': 'Genexine, Inc., Seongnam-si, Gyeonggi-do, Korea.'}, {'ForeName': 'Byung Ha', 'Initials': 'BH', 'LastName': 'Lee', 'Affiliation': 'NeoImmuneTech, Inc., Rockville, Maryland, USA.'}, {'ForeName': 'Se Hwan', 'Initials': 'SH', 'LastName': 'Yang', 'Affiliation': 'NeoImmuneTech, Inc., Rockville, Maryland, USA.'}, {'ForeName': 'Young Chul', 'Initials': 'YC', 'LastName': 'Sung', 'Affiliation': 'Genexine, Inc., Seongnam-si, Gyeonggi-do, Korea.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea.'}]",Clinical and translational science,['10.1111/cts.12800']
1,32340640,Impact of a nutrition education programme on preschool children's willingness to consume fruits and vegetables.,"OBJECTIVE


To evaluate the impact of a preschool-based nutrition education programme consisting of twelve 'hands on' nutrition education lessons delivered during the school year on young children's willingness to consume fruits and vegetables.
DESIGN


Quasi-experimental, pre-post design including the collection of plate waste evaluation data at the start and end of the 2015-2016 school year within two groups: (1) randomly selected classrooms receiving the intervention and (2) within conveniently sampled preschool classrooms not receiving the intervention serving as a comparison group.
SETTING


Centre-based preschool programmes serving low-income families in the Denver metro area.
PARTICIPANTS


Three- to five-year-old children in preschool classrooms participating in the intervention during the 2015-2016 school year (n 308) and children enrolled in comparison classrooms (n 215).
RESULTS


Repeated-measures logit models assessed whether increases in the odds of consuming small samples of fruits and vegetables between Time 1 (pre-intervention) and Time 2 (post-intervention) were different for children within the intervention group compared with the comparison group. Analyses showed that the change over time in consumption of the three vegetable samples varied by intervention status with greater change occurring among children within the intervention group (edamame: P = 0·001; cauliflower: P ≤ 0·0001 and red pepper: P ≤ 0·0001). Unlike vegetables, the change over time in consumption of the two fruit samples was not different between children within the intervention and comparison groups.
CONCLUSIONS


An experiential-learning nutrition education programme can positively influence eating behaviours of low-income preschoolers in a centre-based setting by increasing willingness to consume vegetables.",2020,An experiential-learning nutrition education programme can positively influence eating behaviours of low-income preschoolers in a centre-based setting by increasing willingness to consume vegetables.,"[""preschool children's willingness to consume fruits and vegetables"", ""twelve 'hands on' nutrition education lessons delivered during the school year on young children's willingness to consume fruits and vegetables"", 'Three- to five-year-old children in preschool classrooms participating in the intervention during the 2015-2016 school year (n 308) and children enrolled in comparison classrooms (n 215', 'Centre-based preschool programmes serving low-income families in the Denver metro area', 'low-income preschoolers in a centre-based setting by increasing willingness to consume vegetables']","['preschool-based nutrition education programme', 'nutrition education programme', 'randomly selected classrooms receiving the intervention and (2) within conveniently sampled preschool classrooms not receiving the intervention serving as a comparison group']",['eating behaviours'],"[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0015745', 'cui_str': 'Eating Behavior'}]",,0.0163373,An experiential-learning nutrition education programme can positively influence eating behaviours of low-income preschoolers in a centre-based setting by increasing willingness to consume vegetables.,"[{'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Melnick', 'Affiliation': 'Rocky Mountain Prevention Research Center, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO80045, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'Rocky Mountain Prevention Research Center, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO80045, USA.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Farewell', 'Affiliation': 'Rocky Mountain Prevention Research Center, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO80045, USA.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Quinlan', 'Affiliation': 'Rocky Mountain Prevention Research Center, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO80045, USA.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'LaFlamme', 'Affiliation': 'Rocky Mountain Prevention Research Center, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO80045, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Brogden', 'Affiliation': 'Rocky Mountain Prevention Research Center, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO80045, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Scarbro', 'Affiliation': 'Rocky Mountain Prevention Research Center, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO80045, USA.'}, {'ForeName': 'Jini E', 'Initials': 'JE', 'LastName': 'Puma', 'Affiliation': 'Rocky Mountain Prevention Research Center, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO80045, USA.'}]",Public health nutrition,['10.1017/S1368980019005032']
2,32340910,The impact of heart rate-based drowsiness monitoring on adverse driving events in heavy vehicle drivers under naturalistic conditions.,"OBJECTIVES


This study examined the influence of a wrist-worn heart rate drowsiness detection device on heavy vehicle driver safety and sleep and its ability to predict driving events under naturalistic conditions.
DESIGN


Prospective, non-randomized trial.
SETTING


Naturalistic driving in Malaysia.
PARTICIPANTS


Heavy vehicle drivers in Malaysia were assigned to the Device (n = 25) or Control condition (n = 34).
INTERVENTION


Both conditions were monitored for driving events at work over 4-weeks in Phase 1, and 12-weeks in Phase 2. In Phase 1, the Device condition wore the device operated in the silent mode (i.e., no drowsiness alerts) to examine the accuracy of the device in predicting driving events. In Phase 2, the Device condition wore the device in the active mode to examine if drowsiness alerts from the device influenced the rate of driving events (compared to Phase 1).
MEASUREMENTS


All participants were monitored for harsh braking and harsh acceleration driving events and self-reported sleep duration and sleepiness daily.
RESULTS


There was a significant decrease in the rate of harsh braking events (Rate ratio = 0.48, p < 0.05) and a fall in subjective sleepiness (p < 0.05) when the device was operated in the active mode (compared to the silent mode). The device predicted when no driving events were occurring (specificity=98.81%), but had low accuracy in detecting when a driving event did occur (sensitivity=6.25%).
CONCLUSIONS


Including drowsiness detection devices in fatigue management programs appears to alter driver behaviour, improving safety despite the modest accuracy. Longer term studies are required to determine if this change is sustained.",2020,"There was a significant decrease in the rate of harsh braking events (Rate ratio = 0.48, p < 0.05) and a fall in subjective sleepiness (p < 0.05) when the device was operated in the active mode (compared to the silent mode).","['heavy vehicle drivers under naturalistic conditions', 'Heavy vehicle drivers in Malaysia', 'Naturalistic driving in Malaysia']","['Control condition', 'heart rate-based drowsiness monitoring', 'wrist-worn heart rate drowsiness detection device']","['rate of driving events', 'subjective sleepiness', 'harsh braking and harsh acceleration driving events and self-reported sleep duration and sleepiness daily', 'rate of harsh braking events']","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0337108', 'cui_str': 'Brake'}]",,0.0251325,"There was a significant decrease in the rate of harsh braking events (Rate ratio = 0.48, p < 0.05) and a fall in subjective sleepiness (p < 0.05) when the device was operated in the active mode (compared to the silent mode).","[{'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Wolkow', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, 18 Innovation Walk, Clayton, VIC, Australia.'}, {'ForeName': 'Shantha M W', 'Initials': 'SMW', 'LastName': 'Rajaratnam', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, 18 Innovation Walk, Clayton, VIC, Australia.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Wilkinson', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, 145 Studley Road, PO Box 5555, Heidelberg, VIC, Australia.'}, {'ForeName': 'Dexter', 'Initials': 'D', 'LastName': 'Shee', 'Affiliation': 'Neurobusiness Behavioural Laboratory, Monash University Malaysia, Building 6B, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Baker', 'Affiliation': 'Shell International, Carel van Bylandtlaan 16, The Hague, the Netherlands.'}, {'ForeName': 'Teri', 'Initials': 'T', 'LastName': 'Lillington', 'Affiliation': 'Shell International, Carel van Bylandtlaan 16, The Hague, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Roest', 'Affiliation': 'Shell International, Carel van Bylandtlaan 16, The Hague, the Netherlands.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Marx', 'Affiliation': 'Shell International, Carel van Bylandtlaan 16, The Hague, the Netherlands.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Chew', 'Affiliation': 'Neurobusiness Behavioural Laboratory, Monash University Malaysia, Building 6B, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Tucker', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, 18 Innovation Walk, Clayton, VIC, Australia.'}, {'ForeName': 'Shamsul', 'Initials': 'S', 'LastName': 'Haque', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Department of Psychology, Monash University Malaysia, Jalan Lagoon Selatan, 47500 Bandar Sunway, Selangor Darul Ehsan, Malaysia.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Schaefer', 'Affiliation': 'Neurobusiness Behavioural Laboratory, Monash University Malaysia, Building 6B, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Howard', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, 18 Innovation Walk, Clayton, VIC, Australia; Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, 145 Studley Road, PO Box 5555, Heidelberg, VIC, Australia. Electronic address: mark.howard@austin.org.au.'}]",Sleep health,['10.1016/j.sleh.2020.03.005']
3,32342247,Investigation of fluctuations in blood glucose level due to dietary restrictions during impacted mandibular third molar extraction under intravenous sedation: effect of perioperative glucose administration.,"OBJECTIVE


We aimed to investigate the usefulness of glucose administration for maintaining perioperative glycemic control in patients with dietary restrictions during 4 h prior to impacted mandibular third molar extraction under intravenous sedation.
METHODS


Fifty-four individuals scheduled to undergo extraction of impacted mandibular third molars under intravenous sedation, with preoperative blood glucose levels (GL) of 70-110 mg/dL, were evaluated and divided into 3 groups (n = 18 each): control group receiving glucose-free sodium lactate Ringer's solution, perioperative GL group receiving 100 mL of 5% glucose solution immediately after local anesthesia, and postoperative GL group receiving 100 mL of 5% glucose solution immediately after surgery completion. Blood glucose levels, systolic blood pressure, diastolic blood pressure, and heart rate were measured.
RESULTS


Glucose levels of those in the control and perioperative GL groups decreased within the standard range 90 min after surgery, compared with the preoperative blood glucose level. However, in the postoperative GL group, glucose levels were similar to the preoperative levels. Systolic and diastolic blood pressure and heart rate were not affected by glucose administration, and sedation could be maintained without an invasive procedure.
CONCLUSIONS


Following a restriction on eating and drinking 4 h prior to surgery, the blood glucose level gradually decreased in the perioperative period but remained within the reference range until 90 min following surgery. The administration of 100 mL 5% glucose solution immediately after surgery was sufficient for the prevention of postoperative hypoglycemia. This approach may be useful for perioperative glycemic control during third molar extraction.",2020,"RESULTS


Glucose levels of those in the control and perioperative GL groups decreased within the standard range 90 min after surgery, compared with the preoperative blood glucose level.","['Fifty-four individuals scheduled to undergo extraction of impacted mandibular third molars under intravenous sedation, with preoperative blood glucose levels (GL) of 70-110\xa0mg/dL, were evaluated and divided into 3 groups (n\u2009=\u200918 each', 'patients with dietary restrictions during 4\xa0h prior to impacted mandibular third molar extraction under intravenous sedation']","['glucose administration', ""control group receiving glucose-free sodium lactate Ringer's solution, perioperative GL group receiving 100\xa0mL of 5% glucose solution immediately after local anesthesia, and postoperative GL group receiving 100\xa0mL of 5% glucose solution""]","['blood glucose level', 'glucose levels', 'Systolic and diastolic blood pressure and heart rate', 'Blood glucose levels, systolic blood pressure, diastolic blood pressure, and heart rate', 'preoperative blood glucose level', 'Glucose levels']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0412775', 'cui_str': 'Intravenous sedation'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0142874', 'cui_str': 'Sodium lactate'}, {'cui': 'C0073386', 'cui_str': 'Ringers Solution'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]",54.0,0.0361795,"RESULTS


Glucose levels of those in the control and perioperative GL groups decreased within the standard range 90 min after surgery, compared with the preoperative blood glucose level.","[{'ForeName': 'Mio', 'Initials': 'M', 'LastName': 'Sekine', 'Affiliation': 'Anesthesiology and Resuscitation, The Nippon Dental University Graduate School of Life Dentistry at Niigata, Niigata, Japan. mi0@ngt.ndu.ac.jp.'}, {'ForeName': 'Yuya', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Department of Dental Anesthesiology, The Nippon Dental University School of Life Dentistry at Niigata, 1-8 Hamauracho Chuoku, Niigata, 951-8580, Japan.'}, {'ForeName': 'Asami', 'Initials': 'A', 'LastName': 'Iguchi', 'Affiliation': 'Department of Dental Anesthesiology, The Nippon Dental University School of Life Dentistry at Niigata, 1-8 Hamauracho Chuoku, Niigata, 951-8580, Japan.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Fujii', 'Affiliation': 'Anesthesiology and Resuscitation, The Nippon Dental University Graduate School of Life Dentistry at Niigata, Niigata, Japan.'}]",Oral and maxillofacial surgery,['10.1007/s10006-020-00843-w']
4,31836434,"Progression-free Survival Outcome Is Independent of Objective Response in Patients With Estrogen Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative Advanced Breast Cancer Treated With Palbociclib Plus Letrozole Compared With Letrozole: Analysis From PALOMA-2.","BACKGROUND


In PALOMA-2, palbociclib + letrozole significantly prolonged progression-free survival (PFS) versus placebo + letrozole in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER + /HER2 - ) advanced breast cancer (ABC). We investigated clinical outcomes of patients who achieved or did not achieve a confirmed objective response (OR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (data cutoff: May 31, 2017).
PATIENTS AND METHODS


Postmenopausal patients untreated for ER + /HER2 -  ABC were randomized 2:1 to palbociclib + letrozole or placebo + letrozole. Median PFS, median duration of OR, baseline characteristics, and palbociclib exposure were compared in patients with or without OR by treatment arm.
RESULTS


In the intent-to-treat population, OR was achieved by 194 (44%) of 444 and 77 (35%) of 222 patients in the palbociclib and placebo arms, respectively (odds ratio, 1.5; 95% confidence interval [CI], 1.0-2.1; P = .0156). Regardless of treatment, more OR than non-OR patients had de novo metastatic disease (47%-50% and 28%-31%, respectively) and no prior endocrine therapy (55% and 35%-37%, respectively). Rates of palbociclib dose reduction owing to adverse events were similar regardless of OR (41% and 38%, respectively). Among the patients with OR during the study, approximately 50% achieved OR within the first 3 months regardless of treatment. The median PFS was significantly prolonged with palbociclib + letrozole versus placebo + letrozole in patients with measurable disease in both OR (37.2 months; 95% CI, 28.1 months to not estimable vs. 27.4 months; 95% CI, 22.2-31.1 months; hazard ratio, 0.66; 95% CI, 0.47-0.94; P = .009) and non-OR groups (10.9 months; 95% CI, 8.2-11.2 months vs. 5.6 months; 95% CI, 5.3-8.3 months; hazard ratio, 0.72; 95% CI, 0.54-0.97; P = .016).
CONCLUSIONS


Palbociclib + letrozole provided significant clinical benefit versus placebo + letrozole to patients with ER + /HER2 -  ABC regardless of achieving RECIST-defined OR. Pfizer; ClinicalTrials.gov: NCT01740427.",2020,"The median PFS was significantly prolonged with palbociclib + letrozole versus placebo + letrozole in patients with measurable disease in both OR (37.2 months; 95% CI, 28.1 months to not estimable vs. 27.4 months; 95% CI, 22.2-31.1 months; hazard ratio, 0.66; 95% CI, 0.47-0.94; P = .009) and non-OR groups (10.9 months; 95% CI, 8.2-11.2 months vs. 5.6 months; 95% CI, 5.3-8.3 months; hazard ratio, 0.72; 95% CI, 0.54-0.97; P = .016).
","['patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER + /HER2 - ) advanced breast cancer (ABC', 'patients who achieved or did not achieve a confirmed objective response (OR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (data cutoff', 'Postmenopausal patients untreated for ER + /HER2 -  ABC', 'Patients With']","['placebo\xa0+ letrozole', 'Palbociclib Plus Letrozole', 'letrozole', 'palbociclib\xa0+ letrozole', 'Palbociclib\xa0+ letrozole', 'Letrozole', 'palbociclib\xa0+ letrozole or placebo\xa0+ letrozole', 'placebo']","['Progression-free Survival Outcome', 'de novo metastatic disease', 'Median PFS, median duration of OR, baseline characteristics, and palbociclib exposure', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0279754', 'cui_str': 'ESR1 positive'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",,0.241395,"The median PFS was significantly prolonged with palbociclib + letrozole versus placebo + letrozole in patients with measurable disease in both OR (37.2 months; 95% CI, 28.1 months to not estimable vs. 27.4 months; 95% CI, 22.2-31.1 months; hazard ratio, 0.66; 95% CI, 0.47-0.94; P = .009) and non-OR groups (10.9 months; 95% CI, 8.2-11.2 months vs. 5.6 months; 95% CI, 5.3-8.3 months; hazard ratio, 0.72; 95% CI, 0.54-0.97; P = .016).
","[{'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'Department of Medicine (Hematology/Oncology), University of California San Francisco, Comprehensive Cancer Center, San Francisco, CA. Electronic address: hope.rugo@ucsf.edu.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': 'Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, Santa Monica, CA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gelmon', 'Affiliation': 'Department of Medical Oncology, British Columbia Cancer, Vancouver, BC, Canada.'}, {'ForeName': 'Anil A', 'Initials': 'AA', 'LastName': 'Joy', 'Affiliation': 'Division of Medical Oncology, Cross Cancer Institute, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'Department of OB&GYN, Brustzentrum, Frauenklinik der Universität München (LMU), Munich, Germany.'}, {'ForeName': 'Aurelio', 'Initials': 'A', 'LastName': 'Castrellon', 'Affiliation': 'Memorial Healthcare System, Breast Cancer Center, Pembroke Pines, FL.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Mukai', 'Affiliation': 'Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Janice M', 'Initials': 'JM', 'LastName': 'Walshe', 'Affiliation': ""Department of Medical Oncology, St Vincent's University Hospital and Cancer Trials Ireland, Dublin, Ireland.""}, {'ForeName': 'Ave', 'Initials': 'A', 'LastName': 'Mori', 'Affiliation': 'Global Product Development, Clinical, Pfizer S.r.l., Milan, Italy.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Gauthier', 'Affiliation': 'Global Product Development, Clinical, Pfizer Inc, San Francisco, CA.'}, {'ForeName': 'Dongrui Ray', 'Initials': 'DR', 'LastName': 'Lu', 'Affiliation': 'Pfizer Inc, Clinical Statistics, La Jolla, CA.'}, {'ForeName': 'Eustratios', 'Initials': 'E', 'LastName': 'Bananis', 'Affiliation': 'Pfizer Oncology, US Medical Affairs, New York, NY.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Hospital Gregorio Maranon, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Diéras', 'Affiliation': 'Oncologie sénologique, Centre Eugene Marquis, Rennes, France, and Institut Curie, Paris, France.'}]",Clinical breast cancer,['10.1016/j.clbc.2019.08.009']
5,32346886,Predictors of genetic testing uptake in newly diagnosed breast cancer patients.,"BACKGROUND AND OBJECTIVES


Many newly diagnosed breast cancer patients do not receive genetic counseling and testing at the time of diagnosis. We examined predictors of genetic testing (GT) in this population.
METHODS


Within a randomized controlled trial of proactive rapid genetic counseling and testing vs usual care, patients completed a baseline survey within 6 weeks of breast cancer diagnosis but before a definitive survey. We conducted a multinomial logistic regression to identify predictors of GT timing/uptake.
RESULTS


Having discussed GT with a surgeon was a dominant predictor (χ 2  (2, N = 320) = 70.13; P < .0001). Among those who discussed GT with a surgeon, patients who had made a final surgery decision were less likely to receive GT before surgery compared with postsurgically (OR [odds ratio] = 0.24; 95% confidence interval [CI] = 0.12-0.49) or no testing (OR = 0.28; 95% CI = 0.14-0.56). Older patients (OR = 0.95; 95% CI = 0.91-0.99) and participants enrolled in New York/New Jersey (OR = 0.22; 95% CI = 0.07-0.72) were less likely to be tested compared with receiving results before surgery. Those with higher perceived risk (OR = 1.02; 95% CI = 1.00-1.03) were more likely to receive results before surgery than to not be tested.
CONCLUSIONS


This study highlights the role of patient-physician communication about GT as well as patient-level factors that predict presurgical GT.",2020,"Those with higher perceived risk (OR = 1.02; 95% CI = 1.00-1.03) were more likely to receive results before surgery than to not be tested.
",['newly diagnosed breast cancer patients'],"['proactive rapid genetic counseling and testing vs usual care', 'genetic testing (GT']",['final surgery decision'],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0017382', 'cui_str': 'Genetic counseling'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0679560', 'cui_str': 'Genetic test'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",,0.139548,"Those with higher perceived risk (OR = 1.02; 95% CI = 1.00-1.03) were more likely to receive results before surgery than to not be tested.
","[{'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Ladd', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC.'}, {'ForeName': 'Beth N', 'Initials': 'BN', 'LastName': 'Peshkin', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC.'}, {'ForeName': 'Claudine', 'Initials': 'C', 'LastName': 'Isaacs', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Hooker', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC.'}, {'ForeName': 'Shawna', 'Initials': 'S', 'LastName': 'Willey', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC.'}, {'ForeName': 'Heiddis', 'Initials': 'H', 'LastName': 'Valdimarsdottir', 'Affiliation': 'Department of Population Health Science and Policy, Center for Behavioral Oncology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Tiffani', 'Initials': 'T', 'LastName': 'DeMarco', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': ""O'Neill"", 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC.'}, {'ForeName': 'Savannah', 'Initials': 'S', 'LastName': 'Binion', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC.'}, {'ForeName': 'Marc D', 'Initials': 'MD', 'LastName': 'Schwartz', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of surgical oncology,['10.1002/jso.25956']
6,32347208,"Yoga improves balance, mobility, and perceived occupational performance in adults with chronic brain injury: A preliminary investigation.","BACKGROUND AND PURPOSE


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


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


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


We observed significant improvements in balance, mobility, and self-reported occupational performance in adults with chronic brain injury.",2020,"Significant improvement was observed post-yoga in balance (p = 0.05), mobility (p = 0.03), and self-reported occupational performance (p = 0.04).
","['Nine participants with chronic brain injury were recruited, and seven (four female) completed the study', 'adults with brain injury', 'Participants served as their own controls', 'adults with chronic brain injury']",[],"['self-reported occupational performance', 'balance confidence, pain, and occupational performance and satisfaction', 'balance, mobility, and perceived occupational performance', 'functional deficits', 'balance, mobility, and self-reported occupational performance', 'mobility']","[{'cui': 'C0751813', 'cui_str': 'Chronic Brain Injury'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",9.0,0.0225685,"Significant improvement was observed post-yoga in balance (p = 0.05), mobility (p = 0.03), and self-reported occupational performance (p = 0.04).
","[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Stephens', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: jaclyn.stephens@colostate.edu.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Van Puymbroeck', 'Affiliation': 'Clemson University, Recreational Therapy Program, USA.'}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Sample', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: pat.sample@colostate.edu.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Schmid', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: arlene.schmid@colostate.edu.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101172']
7,32347209,"Evaluation of the effectiveness of self-healing training on self-compassion, body image concern, and recovery process in patients with skin cancer.","BACKGROUND AND PURPOSE


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


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


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


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


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


Self-healing training significantly increased self-compassion, including self-kindness, self-judgment, and sense of common humanity (p < 0.01), and decreased the level of body image concern, isolation, and over-identification (p < 0.05).
","[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Latifi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran. Electronic address: latifizh@gmail.com.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Soltani', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}, {'ForeName': 'Shokoufeh', 'Initials': 'S', 'LastName': 'Mousavi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101180']
8,32347767,Post hoc analysis of reactogenicity trends between dose 1 and dose 2 of the adjuvanted recombinant zoster vaccine in two parallel randomized trials.,"In two large clinical trials (ZOE-50 [NCT01165177] and ZOE-70 [NCT01165229]), two doses of the adjuvanted recombinant zoster vaccine (RZV) demonstrated >90% efficacy against herpes zoster in adults ≥50 years of age. Solicited adverse events (AEs) were collected for 7 days post-each dose in a study sub-cohort. The incidence of reported solicited AEs was higher for RZV compared to placebo recipients. Since reactogenicity may contribute to a person's willingness to be vaccinated, knowing about expected reactogenicity might help keep high compliance with the second dose. This post hoc analysis assessed the intensity of solicited AEs post-dose 2 reported to the same event's intensity post-dose 1. Intensity was graded from 0 to 3, grade 3 indicating the highest severity. Of the vaccinees who did not experience a specific AE post-dose 1, 72.6-91.7% did not experience the same event after dose 2. Although the frequency of grade 3 AEs post-dose 2 was the highest in participants reporting the same AEs at grade 3 post-dose 1, 65.8-89.3% of vaccinees with grade 3 specific AEs post-dose 1 reported the same AEs at lower intensity post-dose 2. These data can help inform health-care professionals about the frequency and intensity of AEs post-dose 2 with respect to post-dose 1.",2020,"Although the frequency of grade 3 AEs post-dose 2 was the highest in participants reporting the same AEs at grade 3 post-dose 1, 65.8-89.3% of vaccinees with grade 3 specific AEs post-dose 1 reported the same AEs at lower intensity post-dose 2.",['adults ≥50 years of age'],"['adjuvanted recombinant zoster vaccine', 'placebo', 'adjuvanted recombinant zoster vaccine (RZV']",['Solicited adverse events (AEs'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C4530095', 'cui_str': 'Varicella zoster virus glycoprotein E, recombinant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.212595,"Although the frequency of grade 3 AEs post-dose 2 was the highest in participants reporting the same AEs at grade 3 post-dose 1, 65.8-89.3% of vaccinees with grade 3 specific AEs post-dose 1 reported the same AEs at lower intensity post-dose 2.","[{'ForeName': 'Romulo', 'Initials': 'R', 'LastName': 'Colindres', 'Affiliation': 'GSK, Rockville, MD, USA.'}, {'ForeName': 'Valentine', 'Initials': 'V', 'LastName': 'Wascotte', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Brecx', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Clarke', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hervé', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Joon Hyung', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'GSK, Rockville, MD, USA.'}, {'ForeName': 'Myron J', 'Initials': 'MJ', 'LastName': 'Levin', 'Affiliation': 'Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Oostvogels', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Toufik', 'Initials': 'T', 'LastName': 'Zahaf', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schuind', 'Affiliation': 'GSK, Rockville, MD, USA.'}, {'ForeName': 'Anthony L', 'Initials': 'AL', 'LastName': 'Cunningham', 'Affiliation': 'The Westmead Institute for Medical Research, University of Sydney, Sydney, Australia.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1741312']
9,32347779,"Re: Ejaculatory Hood Sparing versus Standard Laser Photoselective Vaporization of the Prostate: Sexual and Urodynamic Assessment through a Double Blinded, Randomized TrialA. E. Abolazm, A. S. El-Hefnawy, M. Laymon, A. B. Shehab-El-Din and A. M. Elshal  J Urol  2020;  203:  792-801.",,2020,,[],['Re: Ejaculatory Hood Sparing Versus Standard Laser Photoselective Vaporization'],[],[],"[{'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0348007', 'cui_str': 'Laser Ablation'}]",[],,0.41547,,"[{'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Department of Geriatric Urology, Xiangya Hospital of Central South University, Changsha, Hu Nan, China.'}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Geriatric Urology, Xiangya Hospital of Central South University, Changsha, Hu Nan, China.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Geriatric Urology, Xiangya Hospital of Central South University, Changsha, Hu Nan, China.'}]",The Journal of urology,['10.1097/JU.0000000000001093']
10,32347805,Usability of Food Size Aids in Mobile Dietary Reporting Apps for Young Adults: Randomized Controlled Trial.,"BACKGROUND


Young adults are more likely to use self-managed dietary reporting apps. However, there is scant research examining the user experience of different measurement approaches for mobile dietary reporting apps when dealing with a wide variety of food shapes and container sizes.
OBJECTIVE


Field user experience testing was conducted under actual meal conditions to assess the accuracy, efficiency, and subjective reaction of three food portion measurement methods embedded in a developed mobile app. Key-in-based aid (KBA), commonly used in many current apps, relies on the user's ability to key in volumes or weights. Photo-based aid (PBA) extends traditional assessment methods, allowing users to scroll, observe, and select a reduced-size image from a set of options. Gesture-based aid (GBA) is a new experimental approach in which the user makes finger movements on the screen to roughly describe food portion boundaries accompanied by a background reference.
METHODS


A group of 124 young adults aged 19 to 26 years was recruited for a head-to-head randomized comparison and divided into 3 groups: a KBA (n=42) control group and PBA (n=41) and GBA (n=41) experimental groups. In total, 3 meals (ie, breakfast, lunch, and dinner) were served in a university cafeteria. Participants were provided with 25 dishes and beverages for selection, with a variety of food shapes and containers that reflect everyday life conditions. The accuracy of and time spent on realistic interaction during food portion estimation and the subjective reaction of each aid were recorded and analyzed.
RESULTS


Participants in the KBA group provided the highest accuracy in terms of hash brown weight (P=.004) and outperformed PBA or GBA for many soft drinks in cups. PBA had the best results for a cylindrical hot dog (P<.001), irregularly shaped pork chop (P<.001), and green tea beverage (660 mL; P<.001). GBA outperformed PBA for most drinks, and GBA outperformed KBA for some vegetables. The GBA group spent significantly more time assessing food items than the KBA and PBA groups. For each aid, the overall subjective reaction based on the score of the System Usability Scale was not significantly different.
CONCLUSIONS


Experimental results show that each aid had some distinguishing advantages. In terms of user acceptance, participants considered all 3 aids to be usable. Furthermore, users' subjective opinions regarding measurement accuracy contradicted the empirical findings. Future work will consider the use of each aid based on food or container shape and integrate the various advantages of the 3 different aids for better results. Our findings on the use of portion size aids are based on realistic and diverse food items, providing a useful reference for future app improvement of an effective, evidence-based, and acceptable feature.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Registry ISRCTN36710750; http://www.controlled-trials.com/ISRCTN36710750.",2020,"RESULTS


Participants in the KBA group provided the highest accuracy in terms of hash brown weight (P=.004) and outperformed PBA or GBA for many soft drinks in cups.","['A group of 124 young adults aged 19 to 26 years was recruited for a head-to-head randomized comparison and divided into 3 groups: a', 'Young Adults', 'Young adults']","['Key-in-based aid (KBA', 'Photo-based aid (PBA', 'Food Size Aids', 'Gesture-based aid (GBA', 'control group and PBA', 'GBA', 'KBA']","['System Usability Scale', 'accuracy, efficiency, and subjective reaction', 'time assessing food items']","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",124.0,0.0774607,"RESULTS


Participants in the KBA group provided the highest accuracy in terms of hash brown weight (P=.004) and outperformed PBA or GBA for many soft drinks in cups.","[{'ForeName': 'Ying-Chieh', 'Initials': 'YC', 'LastName': 'Liu', 'Affiliation': 'Department of Industrial Design, College of Management, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Sheng-Tang', 'Initials': 'ST', 'LastName': 'Wu', 'Affiliation': 'Division of Urology, Department of Surgery, Tri-Service General Hospital and National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Shan-Ju', 'Initials': 'SJ', 'LastName': 'Lin', 'Affiliation': 'Department of Industrial Design, College of Management, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Chien-Hung', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'Cyber Security Technology Institute, Institute for Information Industry, Taipei, Taiwan.'}, {'ForeName': 'Yu-Sheng', 'Initials': 'YS', 'LastName': 'Lin', 'Affiliation': 'Health Promotion Center, Department of Internal Medicine, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Hsin-Yun', 'Initials': 'HY', 'LastName': 'Chen', 'Affiliation': 'Department of Nutrition Therapy, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}]",JMIR mHealth and uHealth,['10.2196/14543']
11,32347687,Visual function and subjective perception of vision after bilateral implantation of monofocal and multifocal IOLs: a randomized controlled trial.,"PURPOSE


To examine monocular and binocular visual function and patient-reported outcomes after implantation of multifocal IOLs (mIOLs) or monofocal IOLs, using a rigorous series of clinical assessments.
SETTING


BMI Southend Hospital, United Kingdom.
DESIGN


Prospective, randomized, double-masked clinical trial.
METHODS


One hundred patients were randomized for bilateral implantation of either a Bi-Flex 677MY mIOL or a Bi-Flex 677AB IOL and were assessed at 3 to 6 months (V1) and 12 to 18 months (V2). Primary outcomes included distance, intermediate, and near logarithm of the minimum angle of resolution (logMAR) visual acuities (VAs) and defocus curve profile assessment. Secondary outcomes included reading speed, contrast sensitivity (CS), and the subjective perception of quality of vision.
RESULTS


Forty-seven subjects with monofocal IOL and 43 mIOL subjects completed the study. Uncorrected (mIOL: 0.10 ± 0.09 logMAR; IOL: 0.09 ± 0.11 logMAR) and corrected (mIOL: 0.04 ± 0.06 logMAR; IOL: 0.01 ± 0.07 logMAR) distance VAs were comparable (P > .05). Uncorrected near VA (mIOL: 0.23 ± 0.13 logMAR; IOL: 0.55 ± 0.20 logMAR, P < .001) and distance-corrected near VA (mIOL: 0.24 ± 0.13 logMAR; IOL: 0.54 ± 0.17 logMAR, P < .001) were significantly improved with mIOLs. There was no significant difference in distance-corrected intermediate VA (mIOL: 0.38 ± 0.13 logMAR; IOL: 0.39 ± 0.13 logMAR, P = .431). Defocus curves demonstrated an increased range-of-focus among mIOLs (mIOL: 4.14 ± 1.10 diopter [D]; IOL: 2.57 ± 0.77 D). Pelli-Robson CS was different at V1 (P < .001) but similar by V2 (P = .059). Overall satisfaction was high (>90%) in both groups for distance tasks whereas significantly different for near tasks (mIOL, 18.45 ± 16.53 logUnits; IOL, 55.59 ± 22.52 logUnits).
CONCLUSIONS


Uncorrected near visual acuity was demonstrably better with mIOLs and there was greater subjective satisfaction with quality of near vision. Halos reported by the mIOL group were significant compared with the IOL group but did not show an adverse effect on overall satisfaction.",2020,Unaided near visual acuity was demonstrably better with mIOLs and there was greater subjective satisfaction with quality of near vision.,"['One hundred patients', 'BMI Southend Hospital, United Kingdom']","['bilateral implantation of monofocal and multifocal intraocular lenses', 'implantation of multifocal intraocular lenses (mIOLs) or monofocal intraocular lenses (IOLs', 'Bi-Flex 677MY mIOL or a Bi-Flex 677AB IOL']","['Overall satisfaction', 'overall satisfaction', 'reading speed, contrast sensitivity (CS), and the subjective perception of quality of vision', 'distance-corrected intermediate VA', 'Unaided near visual acuity', 'distance, intermediate and near logarithm of the minimum angle of resolution (logMAR) visual acuities (VA) and defocus curve profile assessment', 'subjective satisfaction with quality of near vision', 'Visual function and subjective perception of vision', 'corrected distance VA']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0493722', 'cui_str': 'Multifocal Intraocular Lens'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0604837', 'cui_str': 'Miol'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C1690987', 'cui_str': 'Intermediate visual acuity'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4759659', 'cui_str': 'With quality'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}]",100.0,0.197295,Unaided near visual acuity was demonstrably better with mIOLs and there was greater subjective satisfaction with quality of near vision.,"[{'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Law', 'Affiliation': 'From the Peninsula Allied Health Centre, School of Health Professions, University of Plymouth (Law, H. Buckhurst, Marsden, Shum, P. J. Buckhurst), Plymouth, BMI Southend Hospital (Law, Aggrawal, Kasaby), Westcliff on Sea, United Kingdom.'}, {'ForeName': 'Rajesh K', 'Initials': 'RK', 'LastName': 'Aggarwal', 'Affiliation': ''}, {'ForeName': 'Hetal', 'Initials': 'H', 'LastName': 'Buckhurst', 'Affiliation': ''}, {'ForeName': 'Hosam E', 'Initials': 'HE', 'LastName': 'Kasaby', 'Affiliation': ''}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Marsden', 'Affiliation': ''}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Shum', 'Affiliation': ''}, {'ForeName': 'Phillip J', 'Initials': 'PJ', 'LastName': 'Buckhurst', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000210']
12,32367124,"High-Intensity Exercise Improves Fatigue, Sleep, and Mood in Patients With Axial Spondyloarthritis: Secondary Analysis of a Randomized Controlled Trial.","OBJECTIVE


Although exercise is recommended in the treatment of axial spondyloarthritis (axSpa), the focus has been on flexibility, and the effect of high-intensity exercises is unknown. The purpose of this study was to investigate the effect of high-intensity exercises on fatigue, sleep, and mood in patients with axSpA.
METHODS


In this secondary analysis of a randomized controlled trial, participants were recruited from outpatient clinics at 4 hospitals in Scandinavia. A total of 100 patients with axSpA were randomized to either an exercise group (n = 50) or a control group (n = 50). High-intensity exercise was provided 3 times per week for 3 months and supervised by a physical therapist. The controls received no intervention. Measurements were self-reported at baseline, 3 months, and 12 months: fatigue, using the Fatigue Severity Scale (range = 0-7, 7 = worst, ≥5 = severe); vitality, using the RAND 36-item short-form health survey (SF-36, range = 0-100, 100 = best); sleep, using the Pittsburgh Sleep Quality Index (range = 0-21, 21 = worst, >5 = poor quality); mood, using the General Health Questionnaire 12 (range = 0-36, 36 = worst); and general health, using the EUROQoL (range = 0-100, 100 = best).
RESULTS


A total of 38 participants (76%) in the exercise group followed ≥80% of the exercise protocol. At 3 months, there was a significant beneficial effect on fatigue (mean group differences = -0.4, 95% CI = -0.7 to -0.1), vitality (5.0, 95% CI = 1.1 to 10.5), mood (-2, 95% CI = -3.7 to -0.04), and general health (9.0, 95% CI = 3.3 to 14.7) but no effect on sleep (-1.1, 95% CI = -2.1 to 0.2). Compared with the control group, the exercise group had a reduced rate of severe fatigue and poor sleep. No differences were seen between the groups at 12 months.
CONCLUSIONS


A 3-month exercise program had a beneficial effect on fatigue, sleep, mood, and general health in patients with axSpA at the end of the intervention; however, no long-term effects were seen.
IMPACT


High-intensity cardiorespiratory and strength exercises should be considered as important in exercise programs for patients with axSpA.",2020,"No differences were seen between the groups at 12 months.
","['One hundred patients with axSpA', 'Patients With Axial Spondyloarthritis', 'patients with axSpA', 'participants were recruited from outpatient clinics at 4 hospitals in Scandinavia']","['High-Intensity Exercise', 'High-intensity exercise', 'high-intensity exercises', 'IMPACT\n\n\nHigh intensity cardiorespiratory and strength exercises', 'exercise group (n\xa0=\xa050) or a control group']","['\xa0worst, ≥5\xa0=\xa0severe); vitality, using the RAND 36-item short-form health survey', 'fatigue', 'fatigue, sleep, mood, and general health', 'Fatigue Severity Scale', 'Fatigue, Sleep, and Mood', 'vitality', 'sleep', 'general health', 'fatigue, sleep, and mood', 'Pittsburgh Sleep Quality Index', 'rate of severe fatigue and poor sleep']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0036273', 'cui_str': 'Nordic Countries'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}]",100.0,0.116561,"No differences were seen between the groups at 12 months.
","[{'ForeName': 'Silje Halvorsen', 'Initials': 'SH', 'LastName': 'Sveaas', 'Affiliation': 'Department of Rheumatology, Norwegian National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Diakonveien 12, Oslo, Norway.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Dagfinrud', 'Affiliation': 'Department of Rheumatology, Norwegian National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital.'}, {'ForeName': 'Inger Jorid', 'Initials': 'IJ', 'LastName': 'Berg', 'Affiliation': 'Department of Rheumatology, Diakonhjemmet Hospital.'}, {'ForeName': 'Sella Arrestad', 'Initials': 'SA', 'LastName': 'Provan', 'Affiliation': 'Department of Rheumatology, Diakonhjemmet Hospital.'}, {'ForeName': 'Melissa Woll', 'Initials': 'MW', 'LastName': 'Johansen', 'Affiliation': 'Department of Physiotherapy, Martina Hansens Hospital, Bærum, Norway.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Pedersen', 'Affiliation': 'Department of Physiotherapy, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Annelie', 'Initials': 'A', 'LastName': 'Bilberg', 'Affiliation': 'Institute of Neuroscience and Physiology, Section of Health and Rehabilitation, Physiotherapy, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Physical therapy,['10.1093/ptj/pzaa086']
13,32344133,Unilateral or Bilateral Percutaneous Endoscopic Debridement and Lavage Treatment for Lumbar Spinal Tuberculosis.,"OBJECTIVE


To compare the clinical outcome between bilateral percutaneous endoscopic debridement and lavage (PEDL) and unilateral PEDL treatment for lumbar spine tuberculosis (LST).
METHODS


A total of 40 patients with LST who underwent either bilateral PEDL (group A) or unilateral PEDL (group B) were reviewed. Perioperative parameters were assessed by operative time, intraoperative fluoroscopy times, and days of postoperative continuous irrigation and vacuum drainage. Clinical outcomes were evaluated in the Oswestry Disability Index (ODI), visual analog scale (VAS), erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP). All patients were followed-up for at least 18 months after treatment.
RESULTS


The average operative time and intraoperative fluoroscopy time were increased in group A compared with those in group B. There was no statistical significance between the 2 groups in postoperative continuous irrigation and vacuum drainage days. The ESR and CRP curves in the 2 groups showed a similar trend during 18-month follow-up. The VAS and ODI in the 2 groups significantly decreased 6 and 18 months postsurgery. There was no significant difference in the incidence of complication between the 2 groups.
CONCLUSIONS


Two procedures yielded comparable and satisfactory results. Unilateral PEDL showed shorter operative time and decreased intraoperative fluoroscopy times compared with bilateral PEDL. We suggest the use of unilateral PEDL rather than bilateral PEDL in the treatment of LST.",2020,The average operative time and the intraoperative fluoroscopy times were increased in group A than those in group,"['lumbar spinal tuberculosis', 'A total of 40 patients with LST who underwent either', 'lumbar spine tuberculosis (LST']","['unilateral PEDL', 'bilateral PEDL', 'bilateral percutaneous endoscopic debridement and lavage (PEDL) and unilateral PEDL treatment', 'Unilateral or bilateral percutaneous endoscopic debridement and lavage treatment']","['intraoperative fluoroscopy times', 'ESR and CRP curves', 'Oswestry Disability Index (ODI), visual analog scale (VAS), erythrocyte sedimentation rate (ESR) and C-reactive protein(CRP', 'VAS and ODI', 'average operative time and the intraoperative fluoroscopy times', 'incidence of complication', 'operative time, intraoperative fluoroscopy times, and days of postoperative continuous irrigation and vacuum drainage', 'shorter operative time']","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0041330', 'cui_str': 'Tuberculosis of vertebral column'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",40.0,0.0250191,The average operative time and the intraoperative fluoroscopy times were increased in group A than those in group,"[{'ForeName': 'Dongying', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Departments of Orthopedics, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China; Department of Orthopedics, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Orthopedics, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Fan', 'Affiliation': 'Departments of Orthopedics, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China. Electronic address: docweiminfan@126.com.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Yuan', 'Affiliation': 'Department of Orthopedics, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}]",World neurosurgery,['10.1016/j.wneu.2020.04.132']
14,32345375,An early intervention to promote maternal sensitivity in the perinatal period for women with psychosocial vulnerabilities: study protocol of a randomized controlled trial.,"BACKGROUND


Maternal mental well-being and social circumstances during pregnancy and early childhood impact the child's well-being and development. Supportive and sensitive parenting is one of the strongest predictors of positive emotional, social and behavioral outcomes for the child. Knowledge is needed about how to detect and support vulnerable families already during pregnancy and in the postnatal period. The aim of this study is to assemble and evaluate an interdisciplinary cross-sectoral intervention to promote maternal sensitivity among women with psychological or social vulnerabilities.
METHODS/DESIGN


This randomized controlled trial tests the efficacy of an intervention program in the perinatal period compared to care as usual in enhancing maternal sensitivity in a group of psychologically or socially vulnerable women in the Capital Region of Denmark. The intervention consists of four components: 1) detecting symptoms of mental illness in vulnerable pregnant women and initiating treatment if indicated, 2) strengthening parenting skills using the Circle of Security Parenting program, 3) supporting breastfeeding, and 4) sharing knowledge and organizing treatment pathways for families across sectors. Seventy-six families will be randomly assigned to the intervention or care-as-usual. Data will be obtained at study inclusion at 3-5 months of pregnancy, eight weeks after childbirth, and nine months after childbirth. The primary outcome is maternal sensitivity. Secondary outcomes include infant's socio-emotional development, parents' mentalization, parental stress, depressive symptoms, and parental wellbeing. Qualitative data will provide insight into the implementation process.
DISCUSSION


This paper presents the rational and background for developing the intervention. Furthermore, the design and protocol of the randomized controlled trial. It is hypothesized that the intervention will be associated with positive changes in primary and secondary outcomes. If effective, the intervention will provide insights into prenatal risk profiles among an identified group of psychosocial vulnerable women important for early screening and point to effective preventive interventions that can support women in the perinatal period, increase maternal sensitivity and promote positive child development -starting before the child is born.
TRIAL REGISTRATION


ClinicalTrials.gov: ID: NCT03190707. Registered June 16, 2017.",2020,"The intervention consists of four components: 1) detecting symptoms of mental illness in vulnerable pregnant women and initiating treatment if indicated, 2) strengthening parenting skills using the Circle of Security Parenting program, 3) supporting breastfeeding, and 4) sharing knowledge and organizing treatment pathways for families across sectors.","['vulnerable pregnant women and', 'women with psychosocial vulnerabilities', 'women with psychological or social vulnerabilities', 'Seventy-six families', 'group of psychologically or socially vulnerable women in the Capital Region of Denmark']","['interdisciplinary cross-sectoral intervention', 'intervention program', 'initiating treatment if indicated, 2) strengthening parenting skills using the Circle of Security Parenting program, 3) supporting breastfeeding, and 4) sharing knowledge and organizing treatment pathways for families across sectors']","[""infant's socio-emotional development, parents' mentalization, parental stress, depressive symptoms, and parental wellbeing"", 'maternal sensitivity']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0439741', 'cui_str': 'Sectoral'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C1171181', 'cui_str': 'Breastfeeding support'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C4704687', 'cui_str': 'Mentalizing'}, {'cui': 'C1999012', 'cui_str': 'Parental role conflict'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",76.0,0.173505,"The intervention consists of four components: 1) detecting symptoms of mental illness in vulnerable pregnant women and initiating treatment if indicated, 2) strengthening parenting skills using the Circle of Security Parenting program, 3) supporting breastfeeding, and 4) sharing knowledge and organizing treatment pathways for families across sectors.","[{'ForeName': 'Anne Kristine', 'Initials': 'AK', 'LastName': 'Aarestrup', 'Affiliation': 'Center for Clinical Research and Prevention, Frederiksberg Hospital, Nordre Fasanvej 57, Vej 8, Indgang 1, 1.sal, 2000, Frederiksberg, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Skovgaard Væver', 'Affiliation': 'Centre for Early Intervention and Family Studies, Department of Psychology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Petersen', 'Affiliation': 'Center for Clinical Research and Prevention, Frederiksberg Hospital, Nordre Fasanvej 57, Vej 8, Indgang 1, 1.sal, 2000, Frederiksberg, Denmark.'}, {'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Røhder', 'Affiliation': 'Center for Clinical Research and Prevention, Frederiksberg Hospital, Nordre Fasanvej 57, Vej 8, Indgang 1, 1.sal, 2000, Frederiksberg, Denmark.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Schiøtz', 'Affiliation': 'Center for Clinical Research and Prevention, Frederiksberg Hospital, Nordre Fasanvej 57, Vej 8, Indgang 1, 1.sal, 2000, Frederiksberg, Denmark. michaela.louise.schioetz@regionh.dk.'}]",BMC psychology,['10.1186/s40359-020-00407-3']
15,32352391,Multidimensional Cognitive Behavioral Therapy for Obesity Applied by Psychologists Using a Digital Platform: Open-Label Randomized Controlled Trial.,"BACKGROUND


Developing effective, widely useful, weight management programs is a priority in health care because obesity is a major health problem.
OBJECTIVE


This study developed and investigated a new, comprehensive, multifactorial, daily, intensive, psychologist coaching program based on cognitive behavioral therapy (CBT) modules. The program was delivered via the digital health care mobile services Noom Coach and InBody.
METHODS


This was an open-label, active-comparator, randomized controlled trial. A total of 70 female participants with BMI scores above 24 kg/m 2  and no clinical problems besides obesity were randomized into experimental and control groups. The experimental (ie, digital CBT) group (n=45) was connected with a therapist intervention using a digital health care service that provided daily feedback and assignments for 8 weeks. The control group (n=25) also used the digital health care service, but practiced self-care without therapist intervention. The main outcomes of this study were measured objectively at baseline, 8 weeks, and 24 weeks and included weight (kg) as well as other body compositions. Differences between groups were evaluated using independent t tests and a per-protocol framework.
RESULTS


Mean weight loss at 8 weeks in the digital CBT group was significantly higher than in the control group (-3.1%, SD 4.5, vs -0.7%, SD 3.4, P=.04). Additionally, the proportion of subjects who attained conventional 5% weight loss from baseline in the digital CBT group was significantly higher than in the control group at 8 weeks (32% [12/38] vs 4% [1/21], P=.02) but not at 24 weeks. Mean fat mass reduction in the digital CBT group at 8 weeks was also significantly greater than in the control group (-6.3%, SD 8.8, vs -0.8%, SD 8.1, P=.02). Mean leptin and insulin resistance in the digital CBT group at 8 weeks was significantly reduced compared to the control group (-15.8%, SD 29.9, vs 7.2%, SD 35.9, P=.01; and -7.1%, SD 35.1, vs 14.4%, SD 41.2, P=.04). Emotional eating behavior (ie, mean score) measured by questionnaire (ie, the Dutch Eating Behavior Questionnaire) at 8 weeks was significantly improved compared to the control group (-2.8%, SD 34.4, vs 21.6%, SD 56.9, P=.048). Mean snack calorie intake in the digital CBT group during the intervention period was significantly lower than in the control group (135.9 kcal, SD 86.4, vs 208.2 kcal, SD 166.3, P=.02). Lastly, baseline depression, anxiety, and self-esteem levels significantly predicted long-term clinical outcomes (24 weeks), while baseline motivation significantly predicted both short-term (8 weeks) and long-term clinical outcomes.
CONCLUSIONS


These findings confirm that technology-based interventions should be multidimensional and are most effective with human feedback and support. This study is innovative in successfully developing and verifying the effects of a new CBT approach with a multidisciplinary team based on digital technologies rather than standalone technology-based interventions.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03465306; https://clinicaltrials.gov/ct2/show/NCT03465306.",2020,"Mean snack calorie intake in the digital CBT group during the intervention period was significantly lower than in the control group (135.9 kcal, SD 86.4, vs 208.2 kcal, SD 166.3, P=.02).","['70 female participants with BMI scores above 24 kg/m 2  and no clinical problems besides obesity', 'Obesity']","['Multidimensional Cognitive Behavioral Therapy', 'digital health care service, but practiced self-care without therapist intervention', 'Digital Platform']","['Mean fat mass reduction', 'Emotional eating behavior', 'Mean weight loss', 'Mean leptin and insulin resistance', 'weight loss', 'Mean snack calorie intake', 'Lastly, baseline depression, anxiety, and self-esteem levels', 'questionnaire (ie, the Dutch Eating Behavior Questionnaire', 'weight (kg) as well as other body compositions']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",70.0,0.113484,"Mean snack calorie intake in the digital CBT group during the intervention period was significantly lower than in the control group (135.9 kcal, SD 86.4, vs 208.2 kcal, SD 166.3, P=.02).","[{'ForeName': 'Meelim', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Biomedical Sciences, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Youngin', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Noom Inc, New York City, NY, United States.'}, {'ForeName': 'Yoonjeong', 'Initials': 'Y', 'LastName': 'Go', 'Affiliation': 'Department of Biomedical Sciences, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seokoh', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Biomedical Sciences, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Myeongjin', 'Initials': 'M', 'LastName': 'Na', 'Affiliation': ""Department of Psychology, Duksung Women's University, Ssangmun-Dong, Dobong-Gu, Republic of Korea.""}, {'ForeName': 'Younghee', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Biomedical Sciences, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sungwon', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': ""Department of Psychology, Duksung Women's University, Ssangmun-Dong, Dobong-Gu, Republic of Korea.""}, {'ForeName': 'Hyung Jin', 'Initials': 'HJ', 'LastName': 'Choi', 'Affiliation': 'Department of Biomedical Sciences, Seoul National University College of Medicine, Seoul, Republic of Korea.'}]",JMIR mHealth and uHealth,['10.2196/14817']
16,32363634,iGlarLixi effectively reduces residual hyperglycaemia in patients with type 2 diabetes on basal insulin: A post hoc analysis from the LixiLan-L study.,"Globally, nearly half of patients with type 2 diabetes (T2D) do not successfully achieve target HbA1c with basal insulin, despite meeting fasting plasma glucose (FPG) targets. In this post hoc analysis of the LixiLan-L study, we determined whether iGlarLixi, a fixed-ratio combination of insulin glargine Gla-100 (iGlar) and the glucagon-like peptide-1 receptor agonist lixisenatide (Lixi), addresses the challenge of reducing residual hyperglycaemia in patients with T2D. In LixiLan-L, a randomized, open-label study, 1018 patients with T2D on basal insulin for ≥6 months ± oral antidiabetes drugs entered a 6-week run-in period, during which they were switched to and/or optimized for a daily dose of iGlar while continuing only metformin. Following the run-in period, 736 patients were then randomized to receive iGlarLixi or were continued on iGlar for 30 weeks ± metformin. Residual hyperglycaemia was defined as HbA1c ≥ 7.0% despite FPG of <140 mg/dL. The proportion of patients with residual hyperglycaemia was similar in both treatment arms at screening (~~42%), and increased after the run-in period (~~62%). After 30 weeks, the proportion of patients with residual hyperglycaemia declined to 23.8% in the iGlarLixi versus 47.1% in the iGlar arm (P < .0001). The proportion of patients achieving both HbA1c (<7.0%) and FPG (<140 mg/dL) targets was higher in the iGlarLixi compared with the iGlar arm (50.3% vs. 27.4%, respectively; P < .0001). iGlarLixi effectively reduces residual hyperglycaemia in patients with T2D on basal insulin therapy.",2020,"The proportion of patients achieving both HbA 1c  (<7.0%) and FPG (<140 mg/dL) targets was higher in the iGlarLixi compared with the iGlar arm (50.3% vs. 27.4%, respectively, p < 0.0001).
","['736 patients', '140', 'patients with T2DM on basal insulin therapy', 'patients with T2DM', 'patients with type 2 diabetes on basal insulin', '1018 patients with T2DM on basal insulin for ≥6 months ± oral antidiabetes drugs entered a 6-week run-in period']","['FPG', 'metformin', 'iGlar while continuing only metformin', 'iGlarLixi', 'iGlarLixi, a fixed-ratio combination of insulin glargine Gla-100 (iGlar) and the glucagon-like peptide-1 receptor agonist lixisenatide (Lixi']","['FPG', 'residual hyperglycemia', 'proportion of patients with residual hyperglycemia', 'Residual hyperglycemia', 'proportion of patients achieving both HbA 1c']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0061078', 'cui_str': 'gamolenic acid'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C2973895', 'cui_str': 'Lixisenatide'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]",1018.0,0.0372836,"The proportion of patients achieving both HbA 1c  (<7.0%) and FPG (<140 mg/dL) targets was higher in the iGlarLixi compared with the iGlar arm (50.3% vs. 27.4%, respectively, p < 0.0001).
","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Morea', 'Affiliation': 'University of Bari Aldo Moro, Bari, Italy.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Retnakaran', 'Affiliation': 'Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Vidal', 'Affiliation': 'Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Minzhi', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'BDM Consulting, Somerset, New Jersey, USA.'}, {'ForeName': 'Aramesh', 'Initials': 'A', 'LastName': 'Saremi', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giorgino', 'Affiliation': 'University of Bari Aldo Moro, Bari, Italy.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14077']
17,32365251,Secukinumab maintains superiority over ustekinumab in clearing skin and improving quality of life in patients with moderate to severe plaque psoriasis: 52-week results from a double-blind phase 3b trial (CLARITY).,"BACKGROUND


Secukinumab demonstrated superior efficacy over ustekinumab in the treatment of moderate to severe plaque psoriasis over 16 weeks in the CLARITY study and over 52 weeks in the CLEAR study.
OBJECTIVE


To compare the efficacy and safety of secukinumab vs. ustekinumab over 52 weeks in CLARITY.
METHODS


Analysis of 52-week data from CLARITY (NCT02826603), a phase 3b study in which patients were randomized to receive secukinumab 300 mg (n = 550) or ustekinumab 45/90 mg (n = 552) per label.
RESULTS


At week 52, secukinumab was superior to ustekinumab in the proportion of patients who achieved ≥ 90% improvement in Psoriasis Area and Severity Index (73.2% vs. 59.8%; odds ratio [OR], 1.84 [95% CI, 1.41-2.41]; P < 0.0001), Investigator's Global Assessment modified 2011 responses of clear (0) or almost clear (1) skin (76.0% vs. 60.2%; OR, 2.12 [95% CI, 1.61-2.79]; P < 0.0001) and Dermatology Life Quality Index response of no effect (0/1) (69.9% vs. 61.2%; P = 0.0028). Proportions of patients with any adverse events were comparable between treatment arms.
CONCLUSIONS


This second head-to-head study confirmed the superior efficacy of secukinumab over ustekinumab in skin clearance and quality of life through 52 weeks, with safety comparable to that reported in previous trials. Clinicaltrials.gov identifier: NCT02826603.",2020,"At week 52, secukinumab was superior to ustekinumab in the proportion of patients who achieved ≥90% improvement in Psoriasis Area and Severity Index (73.2% vs 59.8%; odds ratio [OR], 1.84 [95% CI, 1.41-2.41]; P < .0001), Investigator's Global Assessment modified 2011 responses of clear (0) or almost clear (1) skin (76.0% vs 60.2%; OR, 2.12 [95% CI, 1.61-2.79]; P < .0001), and Dermatology Life Quality Index response of no effect (0/1) (69.9% vs 61.2%; P = .0028).",['patients with moderate to severe plaque psoriasis'],"['Secukinumab', 'secukinumab', 'secukinumab 300 mg (n = 550) or ustekinumab 45/90 mg (n = 552) per label', 'secukinumab vs ustekinumab']","['quality of life', 'skin clearance and quality of life', 'Psoriasis Area and Severity Index', 'Dermatology Life Quality Index response', 'efficacy and safety', ""Investigator's Global Assessment modified 2011 responses of clear (0) or almost clear (1) skin""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}]",,0.300332,"At week 52, secukinumab was superior to ustekinumab in the proportion of patients who achieved ≥90% improvement in Psoriasis Area and Severity Index (73.2% vs 59.8%; odds ratio [OR], 1.84 [95% CI, 1.41-2.41]; P < .0001), Investigator's Global Assessment modified 2011 responses of clear (0) or almost clear (1) skin (76.0% vs 60.2%; OR, 2.12 [95% CI, 1.61-2.79]; P < .0001), and Dermatology Life Quality Index response of no effect (0/1) (69.9% vs 61.2%; P = .0028).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bagel', 'Affiliation': 'Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nia', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hashim', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Patekar', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'de Vera', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ahmad', 'Affiliation': 'Novartis Healthcare Pvt Ltd, Hyderabad, India.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Paguet', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Beijing Novartis Pharma Co, Ltd, Shanghai, China.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Muscianisi', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16558']
18,32361963,Development and Pilot Test of a Virtual Reality Respiratory Biofeedback Approach.,"Breathing exercises with biofeedback have benefits over breathing exercises without biofeedback. However, the traditional measurement of respiratory signals that is required as part of feeding back the breath incurs high cost and effort. We propose a novel virtual reality (VR) based approach to respiratory biofeedback that utilizes the positionally tracked hand controllers integrated into modern VR systems to capture and feedback the respiration-induced abdominal movements. In a randomized controlled laboratory study, we investigated the feasibility and efficacy of the developed biofeedback algorithm. In total, 72 participants performed a short breathing exercise in VR with or without respiratory biofeedback. The feedback integration resulted in a satisfactory user experience, a heightened breath awareness, a greater focus on slow diaphragmatic breathing and an increased respiratory sinus arrhythmia. This evidences that the novel biofeedback approach is low-cost, unobtrusive, usable and effective in increasing breath awareness and promoting slow diaphragmatic breathing in the context of VR-based breathing exercises. Future studies need to investigate the broader applicability and long-term effects.",2020,"The feedback integration resulted in a satisfactory user experience, a heightened breath awareness, a greater focus on slow diaphragmatic breathing and an increased respiratory sinus arrhythmia.",['72 participants performed a'],"['short breathing exercise in VR with or without respiratory biofeedback', 'novel virtual reality (VR) based approach to respiratory biofeedback that utilizes the positionally tracked hand controllers integrated into modern VR systems to capture and feedback the respiration-induced abdominal movements', 'Virtual Reality Respiratory Biofeedback Approach']","['feasibility and efficacy', 'slow diaphragmatic breathing and an increased respiratory sinus arrhythmia']","[{'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1286159', 'cui_str': 'Movement of abdomen'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0231898', 'cui_str': 'Diaphragmatic breathing'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0003813', 'cui_str': 'Sinus arrhythmia'}]",72.0,0.0136611,"The feedback integration resulted in a satisfactory user experience, a heightened breath awareness, a greater focus on slow diaphragmatic breathing and an increased respiratory sinus arrhythmia.","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Blum', 'Affiliation': 'Department of Occupational and Consumer Psychology, Albert-Ludwigs-Universität Freiburg, Engelbergerstr. 41, 79106, Freiburg, Germany. johannes.blum@psychologie.uni-freiburg.de.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Rockstroh', 'Affiliation': 'Department of Occupational and Consumer Psychology, Albert-Ludwigs-Universität Freiburg, Engelbergerstr. 41, 79106, Freiburg, Germany.'}, {'ForeName': 'Anja S', 'Initials': 'AS', 'LastName': 'Göritz', 'Affiliation': 'Department of Occupational and Consumer Psychology, Albert-Ludwigs-Universität Freiburg, Engelbergerstr. 41, 79106, Freiburg, Germany.'}]",Applied psychophysiology and biofeedback,['10.1007/s10484-020-09468-x']
19,32367734,Effects of Far-Infrared Therapy on Foot Circulation Among Hemodialysis Patients With Diabetes Mellitus.,"BACKGROUND


Far-infrared radiation (FIR) therapy improves vessel dilation, circulation, vessel endothelial function, and angiogenesis and reduces atherosclerosis. However, evidence of FIR therapy's effects on foot circulation among diabetic patients undergoing hemodialysis is scarce.
AIM


To determine whether FIR therapy improves foot circulation in diabetic patients undergoing hemodialysis.
DESIGN


Quasi-experimental.
METHODS


In June to November 2017, diabetic patients undergoing hemodialysis ( N  = 58) at a hemodialysis center in northern Taiwan were divided into two groups: the experimental group ( n  = 31) received FIR therapy to the bilateral dorsalis pedis artery (40 min/session, 3 times/week for 6 months) and the control group ( n  = 27) received conventional dialysis care. Paired  t  test, independent samples  t  test, two-proportion  Z  test, and repeated-measures analysis of covariance were performed to compare changes from baseline to the end of the 6-month intervention between the groups.
RESULTS


Significant positive effects of FIR therapy on temperature, pulse, and blood flow of the dorsalis pedis artery were observed. Sensitivity to pain, tactility, and pressure also improved significantly in the experimental group. The Edinburgh Claudication Questionnaire revealed that the experimental group had reductions in subjective experiences of soreness, tingling, and coldness in the feet.
CONCLUSION


The findings of significant improvements to objective and subjective measures of blood flow and neural function in the experimental group indicate that FIR therapy improves blood circulation to the feet. This therapy thus has great potential to be an effective adjuvant treatment for patients with diabetes mellitus undergoing hemodialysis.",2020,"Sensitivity to pain, tactility, and pressure also improved significantly in the experimental group.","['diabetic patients undergoing hemodialysis', 'diabetic patients undergoing hemodialysis is scarce', 'In June to November 2017, diabetic patients undergoing hemodialysis ( N  = 58) at a hemodialysis center in northern Taiwan', 'patients with diabetes mellitus undergoing hemodialysis', 'Hemodialysis Patients With Diabetes Mellitus']","['conventional dialysis care', 'FIR therapy to the bilateral dorsalis pedis artery', 'Far-Infrared Therapy', 'FIR therapy', 'Far-infrared radiation (FIR) therapy']","['Sensitivity to pain, tactility, and pressure', 'subjective experiences of soreness, tingling, and coldness in the feet', 'blood flow and neural function', 'vessel dilation, circulation, vessel endothelial function, and angiogenesis and reduces atherosclerosis', 'Edinburgh Claudication Questionnaire', 'temperature, pulse, and blood flow of the dorsalis pedis artery', 'Foot Circulation', 'foot circulation', 'blood circulation']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1161201', 'cui_str': 'Dialysis care'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0204032', 'cui_str': 'Infrared radiation therapy'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0021431', 'cui_str': 'Infrared radiation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0812387', 'cui_str': 'Feels cold'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C2711423', 'cui_str': 'Edinburgh claudication questionnaire'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}]",,0.0142941,"Sensitivity to pain, tactility, and pressure also improved significantly in the experimental group.","[{'ForeName': 'Yu-Hung', 'Initials': 'YH', 'LastName': 'Wang', 'Affiliation': 'Nursing Department, Keelung Hospital Ministry of Health and Welfare, Keelung City.'}, {'ForeName': 'Fang-Yu', 'Initials': 'FY', 'LastName': 'Cheng', 'Affiliation': 'Institute of Long-Term Care, Mackay Medical College, New Taipei City.'}, {'ForeName': 'Yann-Fen C', 'Initials': 'YC', 'LastName': 'Chao', 'Affiliation': 'College of Nursing, Hungkuang University, Taichung City.'}, {'ForeName': 'Chieh-Yu', 'Initials': 'CY', 'LastName': 'Liu', 'Affiliation': 'Department of Allied Health Education and Digital Learning, National Taipei University of Nursing and Health Sciences, Taipei City.'}, {'ForeName': 'Yuanmay', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Institute of Long-Term Care, Mackay Medical College, New Taipei City.'}]",Biological research for nursing,['10.1177/1099800420923730']
20,32353218,"Effect of a combined exercise program on physical fitness, lung function, and quality of life in patients with controlled asthma and exercise symptoms: A randomized controlled trial.","BACKGROUND


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


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


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


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


Combined exercise training (resistance and aerobic) improved cardiorespiratory fitness and muscle strength in children and adolescents with controlled asthma and exercise symptoms.",2020,"In addition, improvements were observed in leg press (P < .001;  η   p   2     = 0.36), hamstring curl (P = .001;  η   p   2     = 0.217), high row (P = .003;  η   p   2     = .167), low row (P = .009;  ","['children and adolescents diagnosed with mild-moderate asthma and presenting exercise-induced symptoms', 'Fifty-three patients (IG\u2009=\u200925 and CG\u2009=\u200928) with a mean age of 11.5\u2009±\u20092.6 years were included', 'patients with controlled asthma and exercise symptoms', 'mild-moderate asthmatic children with exercise symptoms', 'Asthmatic patients', 'children and adolescents with controlled asthma and exercise symptoms', 'children and adolescents']","['exercise training', 'combined aerobic and resistance training program', 'exercise training (resistance and aerobic', 'combined exercise training (resistance and aerobic) program', 'Combined exercise training (resistance and aerobic', 'combined exercise program']","['leg press', 'quadriceps leg extension', 'cardiorespiratory fitness, muscle strength, lung function, quality of life, asthma control, and functional tests', 'hamstring curl', 'lung function, asthma control, quality of life, and functional tests', 'peak oxygen consumption', 'physical fitness, lung function, and quality of life', 'aerobic fitness, lung function, asthma control and quality of life', 'cardiorespiratory fitness and muscle strength']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}]",,0.0378759,"In addition, improvements were observed in leg press (P < .001;  η   p   2     = 0.36), hamstring curl (P = .001;  η   p   2     = 0.217), high row (P = .003;  η   p   2     = .167), low row (P = .009;  ","[{'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Sanz-Santiago', 'Affiliation': 'Pulmonology Unit, Hospital Universitario Infantil Niño Jesús de Madrid, Madrid, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Diez-Vega', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Santana-Sosa', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Lopez Nuevo', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Iturriaga Ramirez', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Fernanda Maria', 'Initials': 'FM', 'LastName': 'Vendrusculo', 'Affiliation': 'Laboratory of Pediatric Physical Activity, Infant Center, PUCRS, Porto Alegre, Brazil.'}, {'ForeName': 'Márcio Vinícius Fagundes', 'Initials': 'MVF', 'LastName': 'Donadio', 'Affiliation': 'Laboratory of Pediatric Physical Activity, Infant Center, PUCRS, Porto Alegre, Brazil.'}, {'ForeName': 'José Ramón', 'Initials': 'JR', 'LastName': 'Villa Asensi', 'Affiliation': 'Pulmonology Unit, Hospital Universitario Infantil Niño Jesús de Madrid, Madrid, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Pérez-Ruiz', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}]",Pediatric pulmonology,['10.1002/ppul.24798']
21,32358474,"Impact of a Mindfulness-Based, Workplace Group Yoga Intervention on Burnout, Self-Care, and Compassion in Health Care Professionals: A Pilot Study.","OBJECTIVE


To investigate whether a workplace, group mindfulness-based yoga intervention could help manage burnout and improve wellbeing among health care professionals.
METHODS


A total of 43 health care professionals participated in 8-week supervised workplace, group mindfulness-based yoga activities. The authors used a single-sample, pre-post design. At two points in time (baseline and postintervention), participants completed a set of online measures assessing burnout, depression, anxiety, stress, resilience, and compassion. The authors used linear mixed model analysis to assess changes in outcome measures.
RESULTS


Participants had improvements after the 8-week intervention. At postintervention, they had significantly better scores on personal accomplishment, depression, anxiety, stress, perceived resilience, and compassion. Participants had a positive perception of the yoga intervention.
CONCLUSION


Group mindfulness-based yoga program may be convenient and low-cost approach to support health and wellbeing among health care professionals.",2020,"At postintervention, they had significantly better scores on personal accomplishment, depression, anxiety, stress, perceived resilience, and compassion.","['43 health care professionals participated in eight-week', 'Participants had a positive perception of the yoga intervention']","['Mindfulness-based, Workplace Group Yoga Intervention', 'workplace, group mindfulness-based yoga intervention', 'supervised workplace, group mindfulness-based yoga activities']","['personal accomplishment, depression, anxiety, stress, perceived resilience, and compassion', 'online measures assessing burnout, depression, anxiety, stress, resilience, and compassion']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}]",,0.0217367,"At postintervention, they had significantly better scores on personal accomplishment, depression, anxiety, stress, perceived resilience, and compassion.","[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Ofei-Dodoo', 'Affiliation': 'Wichita Department of Family and Community Medicine (Dr Ofei-Dodoo, Dr Nilsen); and Wichita Family Medicine Residency Program at Wesley Medical Center (Dr Cleland-Leighton, Dr Cloward, Dr Casey), University of Kansas School of Medicine, Wichita, Kansas.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Cleland-Leighton', 'Affiliation': ''}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Nilsen', 'Affiliation': ''}, {'ForeName': 'Jacob L', 'Initials': 'JL', 'LastName': 'Cloward', 'Affiliation': ''}, {'ForeName': 'Eastin', 'Initials': 'E', 'LastName': 'Casey', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001892']
22,32357940,Dosing parameters for the effects of high-frequency transcranial magnetic stimulation on smoking cessation: study protocol for a randomized factorial sham-controlled clinical trial.,"BACKGROUND


Despite the considerable success of comprehensive tobacco control efforts, tobacco use remains one of the greatest preventable causes of death and disease today. Over half of all smokers in the US make quit attempts every year, but over 90% relapse within 12 months, choosing the immediate reinforcement of smoking over the long-term benefits of quitting. Conceptual and empirical evidence supports continued investigation of high frequency repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex in reducing relapse and decreasing cigarette consumption. While this evidence is compelling, an optimal dosing strategy must be determined before a long-term efficacy trial can be conducted. The goal of this study is to determine a dosing strategy for 20 Hz rTMS that will produce the best long-term abstinence outcomes with the fewest undesirable effects.
METHODS


This is a fully crossed, double-blinded, sham-controlled, 3x2x2 randomized factorial study. The three factors are duration (stimulation days: 8, 12, and 16); intensity (900 or 1800 pulses per day); and sham control. Participants (n = 258) will consist of adults (18-65) who are motivated to quit smoking cigarettes and who will be followed for 6 months post-quit. Outcomes include latency to relapse, point prevalence abstinence rates, delay discounting rates, cognitive-behavioral skills acquisition, and multiple measures of potential undesirable effects that impact participant compliance.
DISCUSSION


This study integrates existing theoretical concepts and methodologies from neuropsychology, behavioral economics, brain stimulation, clinical psychology, and the evidence-based treatment of tobacco dependence in the development of a promising and innovative approach to treat tobacco dependence. This study will establish an optimal dosing regimen for efficacy testing. Findings are expected to have a significant influence on advancing this approach as well as informing future research on clinical approaches that combine rTMS with other evidence-based treatments for tobacco dependence and perhaps other addictions.
TRIAL REGISTRATION


Clinical Trials NCT03865472 (retrospectively registered). The first participant was fully enrolled on November 26, 2018. Registration was posted on March 7, 2019.",2020,Conceptual and empirical evidence supports continued investigation of high frequency repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex in reducing relapse and decreasing cigarette consumption.,['Participants (n\u2009=\u2009258) will consist of adults (18-65) who are motivated to quit smoking cigarettes and who will be followed for 6\u2009months post-quit'],"['repetitive transcranial magnetic stimulation (rTMS', 'high-frequency transcranial magnetic stimulation']","['latency to relapse, point prevalence abstinence rates, delay discounting rates, cognitive-behavioral skills acquisition, and multiple measures of potential undesirable effects that impact participant compliance']","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C3850035', 'cui_str': 'Intertemporal Preferences'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",,0.372873,Conceptual and empirical evidence supports continued investigation of high frequency repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex in reducing relapse and decreasing cigarette consumption.,"[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Carl', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY, 14203, USA. Ellen.Carl@roswellpark.org.'}, {'ForeName': 'Amylynn', 'Initials': 'A', 'LastName': 'Liskiewicz', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY, 14203, USA.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Rivard', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY, 14203, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Alberico', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY, 14203, USA.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Belal', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY, 14203, USA.'}, {'ForeName': 'Martin C', 'Initials': 'MC', 'LastName': 'Mahoney', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY, 14203, USA.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Quisenberry', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY, 14203, USA.'}, {'ForeName': 'Warren K', 'Initials': 'WK', 'LastName': 'Bickel', 'Affiliation': 'Fralin Biomedical Research Institute at Virginia Tech Carilion, Roanoke, VA, 24016, USA.'}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Sheffer', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY, 14203, USA.'}]",BMC psychology,['10.1186/s40359-020-00403-7']
23,32352912,A Cluster Randomized Controlled Trial of a Lay Health Worker Intervention to Increase Healthy Eating and Physical Activity Among Vietnamese Americans.,"INTRODUCTION


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


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


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


A lay health worker intervention increased both healthy eating and physical activity knowledge and self-reported behaviors among older Vietnamese Americans.",2020,A lay health worker intervention increased both healthy eating and physical activity knowledge and self-reported behaviors among older Vietnamese Americans.,"['Vietnamese Americans', 'Each lay health worker recruited 10 participants aged 50 to 74', 'From 2008 to 2013, using flip charts, lay health workers led 2 educational sessions on HEPA (intervention) or colorectal cancer (comparison', 'older Vietnamese Americans', '64 lay health workers to 2 intervention arms']","['health worker intervention', 'Lay Health Worker Intervention', 'lay health worker intervention', 'fruits and vegetables']","['Healthy Eating and Physical Activity', 'healthy eating and physical activity knowledge and self-reported behaviors', 'HEPA knowledge and self-reported behaviors', 'physical activity weekly', 'Consumption of 5 or more daily servings of fruits and vegetables']","[{'cui': 'C4505363', 'cui_str': 'Vietnamese Americans'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]","[{'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]",64.0,0.0231968,A lay health worker intervention increased both healthy eating and physical activity knowledge and self-reported behaviors among older Vietnamese Americans.,"[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Jih', 'Affiliation': 'Division of General Internal Medicine, University of California, San Francisco, 1545 Divisadero St, San Francisco, CA 94115. Email: jane.jih@ucsf.edu.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Stewart', 'Affiliation': 'Department of Public Health Sciences, University of California, Davis.'}, {'ForeName': 'Thien-Nhien', 'Initials': 'TN', 'LastName': 'Luong', 'Affiliation': 'Vietnamese Reach for Health Coalition, Fremont, California.'}, {'ForeName': 'Tung T', 'Initials': 'TT', 'LastName': 'Nguyen', 'Affiliation': 'Division of General Internal Medicine, University of California, San Francisco.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'McPhee', 'Affiliation': 'Division of General Internal Medicine, University of California, San Francisco.'}, {'ForeName': 'Bang H', 'Initials': 'BH', 'LastName': 'Nguyen', 'Affiliation': 'Research Department, Cancer Prevention Institute of California, Fremont, California.'}]",Preventing chronic disease,['10.5888/pcd17.190353']
24,32357269,A New Stimulation Mode for Deep Brain Stimulation in Parkinson's Disease: Theta Burst Stimulation.,"BACKGROUND AND OBJECTIVES


The purpose of this study was to assess efficacy and safety of a new patterned theta burst stimulation algorithm of DBS with the aim of expanding the therapeutic window and clinical benefit in PD.
METHODS


In this single-center, randomized, double-blind, clinical short-term trial, unilateral conventional subthalamic DBS was compared with unilateral patterned stimulation algorithms with intraburst high- or low-frequency theta burst stimulation in 17 PD patients.
RESULTS


There were no serious adverse events with theta burst stimulation. During monopolar review, conventional subthalamic DBS and high-frequency theta burst stimulation were comparable, but low-frequency theta burst stimulation differed by requiring higher stimulation amplitudes for symptom reduction, but a larger therapeutic window. High- and low-frequency theta burst stimulation with adapted stimulation amplitude were effective in PD symptom reduction with differential effects on akinesia and tremor, depending on the theta burst stimulation mode.
CONCLUSIONS


Theta burst stimulation is a safe and effective stimulation mode with potential future application opportunities. © 2020 International Parkinson and Movement Disorder Society.",2020,"High- and low-frequency theta burst stimulation with adapted stimulation amplitude were effective in PD symptom reduction with differential effects on akinesia and tremor, depending on the theta burst stimulation mode.
",['17 PD patients'],[],['efficacy and safety'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0932235,"High- and low-frequency theta burst stimulation with adapted stimulation amplitude were effective in PD symptom reduction with differential effects on akinesia and tremor, depending on the theta burst stimulation mode.
","[{'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Horn', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Neurology, Hamburg, Germany.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Gulberti', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Neurology, Hamburg, Germany.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Gülke', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Neurology, Hamburg, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Buhmann', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Neurology, Hamburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gerloff', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Neurology, Hamburg, Germany.'}, {'ForeName': 'Christian K E', 'Initials': 'CKE', 'LastName': 'Moll', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Neurophysiology and Pathophysiology, Hamburg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hamel', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Neurosurgery, Hamburg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Volkmann', 'Affiliation': 'University Hospital Würzburg, Department of Neurology, Würzburg, Germany.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Pötter-Nerger', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Neurology, Hamburg, Germany.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28083']
25,32365732,Efficiency of Vitamin D Supplementation in Healthy Adults is Associated with Body Mass Index and Baseline Serum 25-Hydroxyvitamin D Level.,"Vitamin D (VitD) has a critical role in phosphorous-calcium metabolism as well as an important role in the immune system. In the human body, VitD is synthesized as cholecalciferol in the skin, but this process requires sunlight (UVB) radiation. Numerous reports showed high prevalence of VitD deficiency, particularly during the winter season, indicating the importance of VitD supplementation. Various factors can affect the absorption of VitD, including dosage and formulation. The primary study objective was to examine the efficiency of supplementation with three different formulations containing cholecalciferol in comparison with the control group. The secondary objective was to identify other factors affecting increase in serum 25-OH-VitD. A randomized controlled intervention study was conducted in Slovenia during wintertime (January- March) on 105 apparently healthy subjects (aged 18-65 years) with suboptimal VitD status (25-OH-VitD 30-50 nmol/L). Subjects were randomized into four groups: three treatment groups receiving (A) capsules with starch-adsorbed VitD, (B) oil-based Valens VitD oral spray, or (C) water-based Valens VitD oral spray and a control group (D) which did not receive supplemental VitD. Two months of supplementation with cholecalciferol (1000 IU; 25 µg daily) resulted in significant increase in serum 25-OH-VitD levels in comparison with control group (pooled Δc 32.8 nmol/L; 95% CI: 23.0, 42.5,  p  < 0.0001). While we did not observe any significant differences between the tested formulations, the efficiency of supplementation was associated with body mass index and baseline serum 25-OH-VitD level. Higher supplementation efficiency was observed in participants with normal body weight (BMI < 25) and in those with more pronounced VitD insufficiency. We also determined that tested dosage was not sufficient to achieve recommended 25-OH-VitD levels in all subjects.",2020,"While we did not observe any significant differences between the tested formulations, the efficiency of supplementation was associated with body mass index and baseline serum 25-OH-VitD level.","['105 apparently healthy subjects (aged 18-65 years) with suboptimal VitD status (25-OH-VitD 30-50 nmol/L', 'Healthy Adults']","['Vitamin D Supplementation', 'Vitamin D (VitD', 'receiving (A) capsules with starch-adsorbed VitD, (B) oil-based Valens VitD oral spray, or (C) water-based Valens VitD oral spray and a control group (D) which did not receive supplemental VitD', 'cholecalciferol']","['25-OH-VitD levels', 'serum 25-OH-VitD levels', 'body mass index and baseline serum 25-OH-VitD level', 'Higher supplementation efficiency', 'Body Mass Index and Baseline Serum 25-Hydroxyvitamin D Level']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439282', 'cui_str': 'nmol/L'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1154184', 'cui_str': 'Oral spray'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}]",105.0,0.037123,"While we did not observe any significant differences between the tested formulations, the efficiency of supplementation was associated with body mass index and baseline serum 25-OH-VitD level.","[{'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Žmitek', 'Affiliation': 'Nutrition Institute, Tržaška cesta 40, SI-1000 Ljubljana, Slovenia.'}, {'ForeName': 'Maša', 'Initials': 'M', 'LastName': 'Hribar', 'Affiliation': 'Nutrition Institute, Tržaška cesta 40, SI-1000 Ljubljana, Slovenia.'}, {'ForeName': 'Hristo', 'Initials': 'H', 'LastName': 'Hristov', 'Affiliation': 'Nutrition Institute, Tržaška cesta 40, SI-1000 Ljubljana, Slovenia.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Pravst', 'Affiliation': 'Nutrition Institute, Tržaška cesta 40, SI-1000 Ljubljana, Slovenia.'}]",Nutrients,['10.3390/nu12051268']
26,32347815,The Development and Evaluation of a Text Message Program to Prevent Perceived Insufficient Milk Among First-Time Mothers: Retrospective Analysis of a Randomized Controlled Trial.,"BACKGROUND


Several recent trials have examined the feasibility and efficacy of automated SMS text messaging to provide remote breastfeeding support to mothers, but these texting systems vary in terms of design features and outcomes examined.
OBJECTIVE


This study examined user engagement with and feedback on a theory-grounded SMS text messaging intervention intended to prevent perceived insufficient milk (PIM)-the single, leading modifiable cause of unintended breastfeeding reduction and cessation.
METHODS


We recruited 250 nulliparous individuals intending to breastfeed between 13 and 25 weeks of pregnancy in southwestern Pennsylvania. Participants were randomly assigned with equal allocation to either an SMS intervention to prevent PIM and unintended breastfeeding reduction or cessation (MILK, a Mobile, semiautomated text message-based Intervention to prevent perceived Low or insufficient milK supply; n=126) or a control group receiving general perinatal SMS text messaging-based support via the national, free Text4Baby system (n=124). Participants in both groups received SMS text messages 3 to 7 times per week from 25 weeks of pregnancy to 8 weeks postpartum. The MILK intervention incorporated several automated interactivity and personalization features (eg, keyword texting for more detailed information on topics and branched response logic) as well as an option to receive one-on-one assistance from an on-call study lactation consultant. We examined participant interactions with the MILK system, including response rates to SMS text messaging queries. We also sought participant feedback on MILK content, delivery preferences, and overall satisfaction with the system via interviews and a remote survey at 8 weeks postpartum.
RESULTS


Participants randomized to MILK (87/124, 70.2% white and 84/124, 67.7% college educated) reported that MILK texts increased their breastfeeding confidence and helped them persevere through breastfeeding problems. Of 124 participants, 9 (7.3%) elected to stop MILK messages, and 3 (2.4%) opted to reduce message frequency during the course of the study. There were 46 texts through the MILK system for individualized assistance from the study lactation consultant (25/46, 54% on weekends or after-hours). The most commonly texted keywords for more detailed information occurred during weeks 4 to 6 postpartum and addressed milk volume intake and breastfeeding and sleep patterns. MILK participants stated a preference for anticipatory guidance on potential breastfeeding issues and less content addressing the benefits of breastfeeding. Suggested improvements included extending messaging past 8 weeks, providing access to messaging for partners, and tailoring content based on participants' pre-existing breastfeeding knowledge and unique breastfeeding trajectory.
CONCLUSIONS


Prenatal and postpartum evidence-based breastfeeding support delivered via semiautomated SMS text messaging is a feasible and an acceptable intervention for first-time mothers. To optimize engagement with digital breastfeeding interventions, enhanced customization features should be considered.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02724969; https://clinicaltrials.gov/ct2/show/NCT02724969.",2020,"Participants were randomly assigned with equal allocation to either an SMS intervention to prevent PIM and unintended breastfeeding reduction or cessation (MILK, a Mobile, semiautomated text message-based Intervention to prevent perceived Low or insufficient milK supply; n=126) or a control group receiving general perinatal SMS text messaging-based support via the national, free Text4Baby system (n=124).","['Of 124 participants, 9 (7.3%) elected to stop MILK messages, and 3 (2.4%) opted to reduce message frequency during the course of the study', '250 nulliparous individuals intending to breastfeed between 13 and 25 weeks of pregnancy in southwestern Pennsylvania']","['MILK', 'automated SMS text messaging', 'MILK intervention', 'SMS text messages', 'SMS intervention to prevent PIM and unintended breastfeeding reduction or cessation (MILK, a Mobile, semiautomated text message-based Intervention to prevent perceived Low or insufficient milK supply; n=126) or a control group receiving general perinatal SMS text messaging-based support via the national, free Text4Baby system']","['MILK content, delivery preferences, and overall satisfaction', 'MILK texts increased their breastfeeding confidence and helped them persevere through breastfeeding problems']","[{'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C1283932', 'cui_str': 'Unintentional'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",250.0,0.113473,"Participants were randomly assigned with equal allocation to either an SMS intervention to prevent PIM and unintended breastfeeding reduction or cessation (MILK, a Mobile, semiautomated text message-based Intervention to prevent perceived Low or insufficient milK supply; n=126) or a control group receiving general perinatal SMS text messaging-based support via the national, free Text4Baby system (n=124).","[{'ForeName': 'Jill R', 'Initials': 'JR', 'LastName': 'Demirci', 'Affiliation': 'Department of Health Promotion & Development, University of Pittsburgh School of Nursing, Pittsburgh, PA, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Suffoletto', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Doman', 'Affiliation': 'Office of Academic Computing, Western Psychiatric Institute and Clinic, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Glasser', 'Affiliation': 'Department of Health Promotion & Development, University of Pittsburgh School of Nursing, Pittsburgh, PA, United States.'}, {'ForeName': 'Judy C', 'Initials': 'JC', 'LastName': 'Chang', 'Affiliation': 'Department of Obstetrics, Gynecology & Reproductive Sciences, and Internal Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sereika', 'Affiliation': 'Department of Health & Community Systems, Center for Research and Evaluation, University of Pittsburgh School of Nursing, Pittsburgh, PA, United States.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Bogen', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States.""}]",JMIR mHealth and uHealth,['10.2196/17328']
27,32348267,Pragmatic Strategy Empowering Paramedics to Assess Low-Risk Trauma Patients With the Canadian C-Spine Rule and Selectively Transport Them Without Immobilization: Protocol for a Stepped-Wedge Cluster Randomized Trial.,"BACKGROUND


Each year, half a million patients with a potential neck (c-spine) injury are transported to Ontario emergency departments (EDs). Less than 1.0% (1/100) of these patients have a neck bone fracture. Even less (1/200, 0.5%) have a spinal cord injury or nerve damage. Currently, paramedics transport all trauma victims (with or without an injury) by ambulance using a backboard, cervical collar, and head immobilizers. Importantly, prolonged immobilization is often unnecessary; it causes patient discomfort and pain, decreases community access to paramedics, contributes to ED crowding, and is very costly. We therefore developed the Canadian C-Spine Rule (CCR) for alert and stable trauma patients. This decision rule helps ED physicians and triage nurses to safely and selectively remove immobilization, without x-rays and missed injury. We successfully taught Ottawa paramedics to use the CCR in the field in a single-center study.
OBJECTIVE


This study aimed to improve patient care and health system efficiency and outcomes by allowing paramedics to assess eligible low-risk trauma patients with the CCR and selectively transport them without immobilization to the ED.
METHODS


We propose a pragmatic stepped-wedge cluster randomized design with health economic evaluation, designed collaboratively with knowledge users. Our 36-month study will consist of a 12-month setup and training period (year 1), followed by the stepped-wedge trial (year 2) and a 12-month period for study completion, analyses, and knowledge translation. A total of 12 Ontario paramedic services of various sizes distributed across the province will be randomly allocated to one of three sequences. Paramedic services in each sequence will cross from the control condition (usual care) to the intervention condition (CCR implementation) at intervals of 3 months until all communities have crossed to the intervention. Data will be collected on all eligible patients in each paramedic service for a total duration of 12 months. A major strength of our design is that each community will have implemented the CCR by the end of the study.
RESULTS


Interim results are expected in December 2019 and final results in 2020. If this multicenter trial is successful, we expect the Ontario Ministry of Health will recommend that paramedics evaluate all eligible patients with the CCR in the Province of Ontario.
CONCLUSIONS


We conservatively estimate that in Ontario, more than 60% of all eligible trauma patients (300,000 annually) could be transported safely and comfortably, without c-spine immobilization devices. This will significantly reduce patient pain and discomfort, paramedic intervention times, and ED length of stay, thereby improving access to paramedics and ED care. This could be achieved rapidly and with lower health care costs compared with current practices (possible cost saving of Can $36 [US $25] per immobilization or Can $10,656,000 [US $7,335,231] per year).
TRIAL REGISTRATION


ClinicalTrials.gov NCT02786966; https://clinicaltrials.gov/ct2/show/NCT02786966.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/16966.",2020,Paramedic services in each sequence will cross from the control condition (usual care) to the intervention condition (CCR implementation) at intervals of 3 months until all communities have crossed to the intervention.,"['eligible patients in each paramedic service for a total duration of 12 months', 'eligible low-risk trauma patients with the CCR and selectively transport them without immobilization to the ED', 'million patients with a potential neck (c-spine) injury are transported to Ontario emergency departments (EDs', 'Low-Risk Trauma Patients', 'eligible patients with the CCR in the Province of Ontario', '12 Ontario paramedic services of various sizes distributed across the province']","['Canadian C-Spine Rule and Selectively Transport', 'Canadian C-Spine Rule (CCR']","['spinal cord injury or nerve damage', 'patient pain and discomfort, paramedic intervention times, and ED length of stay, thereby improving access to paramedics and ED care', 'neck bone fracture']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0456389', 'cui_str': 'Size'}]","[{'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}]","[{'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0161479', 'cui_str': 'Nerve injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]",,0.116697,Paramedic services in each sequence will cross from the control condition (usual care) to the intervention condition (CCR implementation) at intervals of 3 months until all communities have crossed to the intervention.,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Vaillancourt', 'Affiliation': 'Department of Emergency Medicine, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Manya', 'Initials': 'M', 'LastName': 'Charette', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Kednapa', 'Initials': 'K', 'LastName': 'Thavorn', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Patient Representative, Owner-Hall Consulting, Director-Helping Hands for India, Kanata, ON, Canada.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'McLeod', 'Affiliation': 'Paramedic Representative, Hamilton Paramedic Service, Hamilton, ON, Canada.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Fergusson', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Brehaut', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Graham', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Calder', 'Affiliation': 'Medical Care Analytics, Canadian Medical Protective Association, Ottawa, ON, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Ramsay', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Tugwell', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kelly', 'Affiliation': 'Ottawa Paramedic Service, Ottawa, ON, Canada.'}, {'ForeName': 'Sheldon', 'Initials': 'S', 'LastName': 'Cheskes', 'Affiliation': 'Department of Family and Community Medicine, Division of Emergency Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Refik', 'Initials': 'R', 'LastName': 'Saskin', 'Affiliation': 'Institute for Clinical Evaluative Sciences, Toronto, ON, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Plint', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, ON, Canada.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Osmond', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, ON, Canada.""}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Macarthur', 'Affiliation': 'Clinical Research Services, SickKids, Toronto, ON, Canada.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Straus', 'Affiliation': ""Knowledge Translation Program, St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Rochon', 'Affiliation': ""Women's College Research Institute, Toronto, ON, Canada.""}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': ""Prud'homme"", 'Affiliation': ""Institut de recherche de l'Hôpital Montfort, Ottawa, ON, Canada.""}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Dahrouge', 'Affiliation': 'Élisabeth Bruyère Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Marlin', 'Affiliation': 'Clinical Trials Ontario, Toronto, ON, Canada.'}, {'ForeName': 'Ian G', 'Initials': 'IG', 'LastName': 'Stiell', 'Affiliation': 'Department of Emergency Medicine, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada.'}]",JMIR research protocols,['10.2196/16966']
28,32348270,A Mobile Health Intervention System for Women With Coronary Heart Disease: Usability Study.,"BACKGROUND


Coronary heart disease (CHD) is the leading cause of death and disability among American women. The prevalence of CHD is expected to increase by more than 40% by 2035. In 2015, the estimated cost of caring for patients with CHD was US $182 billion in the United States; hospitalizations accounted for more than half of the costs. Compared with men, women with CHD or those who have undergone coronary revascularization have up to 30% more rehospitalizations within 30 days and up to 1 year. Center-based cardiac rehabilitation is the gold standard of care after an acute coronary event, but few women attend these valuable programs. Effective home-based interventions for improving cardiovascular health among women with CHD are vital for addressing this gap in care.
OBJECTIVE


The ubiquity of mobile phones has made mobile health (mHealth) behavioral interventions a viable option to improve healthy behaviors of both women and men with CHD. First, this study aimed to examine the usability of a prototypic mHealth intervention designed specifically for women with CHD (herein referred to as HerBeat). Second, we examined the influence of HerBeat on selected health behaviors (self-efficacy for diet, exercise, and managing chronic illness) and psychological (perceived stress and depressive symptoms) characteristics of the participants.
METHODS


Using a single-group, pretest, posttest design, 10 women participated in the 12-week usability study. Participants were provided a smartphone and a smartwatch on which the HerBeat app was installed. Using a web portal dashboard, a health coach monitored participants' ecological momentary assessment data, their behavioral data, and their heart rate and step count. Participants then completed a 12-week follow-up assessment.
RESULTS


All 10 women (age: mean 64.4 years, SD 6.3 years) completed the study. The usability and acceptability of HerBeat were good, with a mean system usability score of 83.60 (SD 16.3). The participants demonstrated statistically significant improvements in waist circumference (P=.048), weight (P=.02), and BMI (P=.01). Furthermore, depressive symptoms, measured with the Patient Health Questionnaire-9, significantly improved from baseline (P=.04).
CONCLUSIONS


The mHealth prototype was feasible and usable for women with CHD. Participants provided data that were useful for further development of HerBeat. The mHealth intervention is expected to help women with CHD self-manage their health behaviors. A randomized controlled trial is needed to further verify the findings.",2020,"The participants demonstrated statistically significant improvements in waist circumference (P=.048), weight (P=.02), and BMI (P=.01).","['Women With Coronary Heart Disease', 'American women', 'women with CHD', '10 women participated in the 12-week usability study', 'All 10 women (age: mean 64.4 years, SD 6.3 years) completed the study', 'women with CHD (herein referred to as HerBeat', 'women and men with CHD']","['Mobile Health Intervention System', 'Center-based cardiac rehabilitation']","['Patient Health Questionnaire-9', 'waist circumference', 'weight (P=.02), and BMI', 'cardiovascular health', 'mean system usability score', 'estimated cost of caring', 'prevalence of CHD', 'selected health behaviors (self-efficacy for diet, exercise, and managing chronic illness) and psychological (perceived stress and depressive symptoms', 'Furthermore, depressive symptoms']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",10.0,0.10749,"The participants demonstrated statistically significant improvements in waist circumference (P=.048), weight (P=.02), and BMI (P=.01).","[{'ForeName': 'Avijit', 'Initials': 'A', 'LastName': 'Sengupta', 'Affiliation': 'Information Systems and Decision Sciences, University of South Florida, Tampa, FL, United States.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Beckie', 'Affiliation': 'College of Nursing, University of South Florida, Tampa, FL, United States.'}, {'ForeName': 'Kaushik', 'Initials': 'K', 'LastName': 'Dutta', 'Affiliation': 'Information Systems and Decision Sciences, University of South Florida, Tampa, FL, United States.'}, {'ForeName': 'Arup', 'Initials': 'A', 'LastName': 'Dey', 'Affiliation': 'College of Engineering, University of South Florida, Tampa, FL, United States.'}, {'ForeName': 'Sriram', 'Initials': 'S', 'LastName': 'Chellappan', 'Affiliation': 'College of Engineering, University of South Florida, Tampa, FL, United States.'}]",JMIR formative research,['10.2196/16420']
29,32348282,Correction: A Smartphone App to Improve Medication Adherence in Patients With Type 2 Diabetes in Asia: Feasibility Randomized Controlled Trial.,[This corrects the article DOI: 10.2196/14914.].,2020,[This corrects the article DOI: 10.2196/14914.].,['Patients With Type 2 Diabetes in Asia'],['Smartphone App'],['Medication Adherence'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0003980', 'cui_str': 'Asia'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",,0.0584139,[This corrects the article DOI: 10.2196/14914.].,"[{'ForeName': 'Zhilian', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Eberta', 'Initials': 'E', 'LastName': 'Tan', 'Affiliation': 'Department of Endocrinology, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Lum', 'Affiliation': 'Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sloot', 'Affiliation': 'Complexity Institute, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Bernhard Otto', 'Initials': 'BO', 'LastName': 'Boehm', 'Affiliation': 'Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Josip', 'Initials': 'J', 'LastName': 'Car', 'Affiliation': 'Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.'}]",JMIR mHealth and uHealth,['10.2196/18411']
30,32349025,The Effect of Cell Phones on Attention and Learning in Nursing Students.,"The use of cell phones can have a negative effect on nursing students' academic performance. The purpose of this study was to identify the effects that problematic cell phone use and nomophobia have on learning in nursing students. A quasi-experimental study was carried out among nursing students, with a control group (n = 61, 49.2%) and an experimental group (n = 63, 50.8%). The experimental group left their cell phones, in sound or vibration mode, as they normally kept them, on a table located in the corner of the classroom. Both groups showed higher-than-average levels of nomophobia at the beginning of the class. As for problematic cell phone use and attention, it was found that there were statistically significant differences in both cases (U = 1355.500, Z = -2.830, P = .005; U = 1449.000, Z = -2.363, P = .018, respectively), and the experimental group had higher average scores, as well as in those related to knowledge. A relationship has been found between nomophobia and problematic cell phone use. Students who do not have access to their cell phones during class perceive more problematic cell phone usage, in addition to paying closer attention during class. Because of this, it is important to create policies and norms restricting cell phone use during all types of academic training among nursing students.",2020,"As for problematic cell phone use and attention, it was found that there were statistically significant differences in both cases (U = 1355.500, Z = -2.830, P = .005; U = 1449.000, Z = -2.363, P = .018, respectively), and the experimental group had higher average scores, as well as in those related to knowledge.","['nursing students, with a control group (n = 61, 49.2%) and an experimental group (n = 63, 50.8', 'nursing students', 'Nursing Students']",['Cell Phones'],[],"[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1136359', 'cui_str': 'Cellular Phone'}]",[],,0.0135394,"As for problematic cell phone use and attention, it was found that there were statistically significant differences in both cases (U = 1355.500, Z = -2.830, P = .005; U = 1449.000, Z = -2.363, P = .018, respectively), and the experimental group had higher average scores, as well as in those related to knowledge.","[{'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Gutiérrez-Puertas', 'Affiliation': 'Author Affiliations: Department of Nursing, Physiotherapy and Medicine, Faculty of Health Sciences (Dr Gutiérrez-Puertas and Ms Gutiérrez-Puertas) and Department of Nursing, Physiotherapy and Medicine, Faculty of Health Sciences, Research Group of Health Sciences CTS-451 (Drs Márquez-Hernández, Granados-Gámez, and Aguilera-Manrique), University of Almeria, Spain.'}, {'ForeName': 'Verónica V', 'Initials': 'VV', 'LastName': 'Márquez-Hernández', 'Affiliation': ''}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Gutiérrez-Puertas', 'Affiliation': ''}, {'ForeName': 'Genoveva', 'Initials': 'G', 'LastName': 'Granados-Gámez', 'Affiliation': ''}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Aguilera-Manrique', 'Affiliation': ''}]","Computers, informatics, nursing : CIN",['10.1097/CIN.0000000000000626']
31,32378422,Effect of nocturnal melatonin intake on cellular damage and recovery from repeated sprint performance during an intensive training schedule.,"An optimal recovery between training sessions is of similar if not greater importance as the training content and program of the training, itself. One of the most used strategies for improving recovery is the ingestion of supplements. The present study aimed to evaluate the effect of 5 mg oral melatonin supplementation on the recovery from repeated sprint (RSA) of performance and biochemical responses ( i.e . oxidative stress, leukocytosis cellular damage) after an intensive training camp (TC). Twenty soccer players performed an RSA test before and after an intensive six-day TC associated with nocturnal melatonin (n = 10) or placebo (n = 10) ingestion. Resting and post-RSA test blood samples were obtained before and after the TC. Compared to placebo, melatonin intake decreased resting oxidative stress markers ( i.e , advanced oxidation protein products), leukocytosis ( i.e . white blood cells (WBC), neutrophils (NE)) and biomarkers of cellular damage ( i.e . creatine kinase (CK)). It also lowered post-exercise leukocytosis ( i.e . WBC, NE, lymphocytes (LY), monocytes (MO)) and biomarkers of cellular damage ( i.e . CK, aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT)) and raised the activity of the main antioxidant enzymes ( i.e . glutathione peroxidase (GPx), glutathione reductase (GR)). In addition, compared to placebo, melatonin reduced the deterioration of the best and total time during the RSA test after the TC. In conclusion, nocturnal melatonin supplementation during an intensive TC alleviated oxidative stress, leukocytosis and cellular damage and improved recovery of RSA performance in soccer players.",2020,"Compared to placebo, melatonin intake decreased resting oxidative stress markers ( i.e , advanced oxidation protein products), leukocytosis ( i.e . white blood cells (WBC), neutrophils (NE)) and biomarkers of cellular damage ( i.e . creatine kinase (CK)).","['Twenty soccer players', 'soccer players']","['intensive training camp (TC', 'nocturnal melatonin (n\xa0=\xa010) or placebo', 'oral melatonin supplementation', 'placebo, melatonin', 'nocturnal melatonin intake', 'nocturnal melatonin supplementation']","['cellular damage and recovery from repeated sprint performance', 'post-exercise leukocytosis ( i.e . WBC, NE, lymphocytes (LY), monocytes (MO)) and biomarkers of cellular damage ( i.e . CK, aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT)) and raised the activity of the main antioxidant enzymes ( i.e . glutathione peroxidase (GPx), glutathione reductase (GR', 'oxidative stress, leukocytosis and cellular damage and improved recovery of RSA performance', 'deterioration of the best and total time', 'resting oxidative stress markers ( i.e , advanced oxidation protein products), leukocytosis ( i.e . white blood cells (WBC), neutrophils (NE)) and biomarkers of cellular damage ( i.e . creatine kinase (CK', 'recovery from repeated sprint (RSA) of performance and biochemical responses ( i.e . oxidative stress, leukocytosis cellular damage']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0023518', 'cui_str': 'Leukocytosis'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0017824', 'cui_str': 'Glutathione reductase (NAD(P)H)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1976991', 'cui_str': 'Advanced oxidation protein products'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}]",,0.132672,"Compared to placebo, melatonin intake decreased resting oxidative stress markers ( i.e , advanced oxidation protein products), leukocytosis ( i.e . white blood cells (WBC), neutrophils (NE)) and biomarkers of cellular damage ( i.e . creatine kinase (CK)).","[{'ForeName': 'Mohamed Amine', 'Initials': 'MA', 'LastName': 'Farjallah', 'Affiliation': 'High Institute of Sport and Physical Education, Manouba University, Ksar-Saïd , Tunis, Tunisia.'}, {'ForeName': 'Kais', 'Initials': 'K', 'LastName': 'Ghattassi', 'Affiliation': 'High Institute of Sport and Physical Education, Manouba University, Ksar-Saïd , Tunis, Tunisia.'}, {'ForeName': 'Lobna', 'Initials': 'L', 'LastName': 'Ben Mahmoud', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, University of Sfax , Sfax, Tunisia.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Graja', 'Affiliation': 'High Institute of Sport and Physical Education, Manouba University, Ksar-Saïd , Tunis, Tunisia.'}, {'ForeName': 'Mariem', 'Initials': 'M', 'LastName': 'Boudaya', 'Affiliation': 'Biochemistry Laboratory, CHU Hedi Chaker, University of Sfax , Sfax, Tunisia.'}, {'ForeName': 'Henda', 'Initials': 'H', 'LastName': 'Elleuch', 'Affiliation': 'Hematology Laboratory, CHU Hedi Chaker, University of Sfax , Sfax, Tunisia.'}, {'ForeName': 'Kamel', 'Initials': 'K', 'LastName': 'Jammoussi', 'Affiliation': 'Biochemistry Laboratory, CHU Hedi Chaker, University of Sfax , Sfax, Tunisia.'}, {'ForeName': 'Zouheir', 'Initials': 'Z', 'LastName': 'Sahnoun', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, University of Sfax , Sfax, Tunisia.'}, {'ForeName': 'Nizar', 'Initials': 'N', 'LastName': 'Souissi', 'Affiliation': 'Physical Activity, Sport and Health, UR18JS01, National Observatory of Sport , Tunis, Tunisia.'}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Chtourou', 'Affiliation': 'Physical Activity, Sport and Health, UR18JS01, National Observatory of Sport , Tunis, Tunisia.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Hammouda', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical Activity, Health and Learning (LINP2-APSA), UPL, Paris Nanterre University, UFR STAPS , Nanterre, France.'}]",Chronobiology international,['10.1080/07420528.2020.1746797']
32,32358482,Postprandial blood glucose response: does the glycaemic index (GI) value matter even in the low GI range?,"A growing body of research over the last decades has shown that diets based on the low glycaemic index (GI) foods reduce the risk of developing diabetes and improve blood glucose control in people with diabetes. The range of inflexion on the glycaemic response of low GI (LGI) foods is an interesting observation that has not been studied by many. LGI 1 (GI 54 ± 3.3) biscuit was formulated using a basic formulation while the LGI 2 (23.8 ± 3.3) biscuits was a modification of LGI 1 recipe, formulated with the inclusion of functional ingredients. Biscuits were formulated to be iso-caloric (kcal/100 g: 521 ± 12). Each participant consumed identical standard meals for lunch and dinner. Biscuits were consumed as breakfast and mid-afternoon snack. Using a randomized, controlled, crossover study, 13 males [(means ± SD) age: 25.3 ± 1.0 years, BMI 21.6 ± 0.5 kg/m 2 , fasting blood glucose 4.7 ± 0.1 mmol/L] wore continuous glucose monitoring systems (CGMS™) for 3 days for each test session. The postprandial glycaemic response and insulin response were compared within participants. Total iAUC for breakfast and standard dinner were significantly lower for LGI 2 treatment (p < 0.05) than LGI 1 treatment. Second-meal glucose tolerance was observed at the dinner meal. The overall iAUC insulin response over 180 min was significantly lower for LGI 2 biscuits (p = 0.01). The postprandial glycaemic response of two types of biscuits that fall within the low GI classification (GI 24 and 54) differed with LGI 2 biscuits (GI 24) showing a more suppressed postprandial glycaemic response. Our study shows that even within the low GI range, the GI value matters in influencing postprandial glucose.",2020,Total iAUC for breakfast and standard dinner were significantly lower for LGI 2 treatment (p < 0.05) than LGI 1 treatment.,"['people with diabetes', '13 males [(means\u2009±\u2009SD) age: 25.3\u2009±\u20091.0 years, BMI 21.6\u2009±\u20090.5\u2009kg/m 2 , fasting blood glucose 4.7\u2009±\u20090.1\u2009mmol/L] wore continuous glucose monitoring systems (CGMS™) for 3 days for each test session']",[],"['postprandial glycaemic response', 'Postprandial blood glucose response', 'overall iAUC insulin response', 'blood glucose control', 'Total iAUC for breakfast and standard dinner', 'postprandial glycaemic response and insulin response', 'Second-meal glucose tolerance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",[],"[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",13.0,0.0215795,Total iAUC for breakfast and standard dinner were significantly lower for LGI 2 treatment (p < 0.05) than LGI 1 treatment.,"[{'ForeName': 'Bhupinder', 'Initials': 'B', 'LastName': 'Kaur', 'Affiliation': 'Clinical Nutrition Research Centre (CNRC), Singapore Institute of Food and Biotechnology Innovation (SIFBI), Agency for Science, Technology and Research (A*STAR), Singapore, Singapore.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'Koh', 'Affiliation': 'Clinical Nutrition Research Centre (CNRC), Singapore Institute of Food and Biotechnology Innovation (SIFBI), Agency for Science, Technology and Research (A*STAR), Singapore, Singapore.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Ponnalagu', 'Affiliation': 'Clinical Nutrition Research Centre (CNRC), Singapore Institute of Food and Biotechnology Innovation (SIFBI), Agency for Science, Technology and Research (A*STAR), Singapore, Singapore.'}, {'ForeName': 'Christiani Jeyakumar', 'Initials': 'CJ', 'LastName': 'Henry', 'Affiliation': 'Clinical Nutrition Research Centre (CNRC), Singapore Institute of Food and Biotechnology Innovation (SIFBI), Agency for Science, Technology and Research (A*STAR), Singapore, Singapore. jeya_henry@sifbi.a-star.edu.sg.'}]",Nutrition & diabetes,['10.1038/s41387-020-0118-5']
33,32299853,Experimental dyspnoea interferes with locomotion and cognition: a randomised trial.,"BACKGROUND


Chronic respiratory diseases are associated with cognitive dysfunction, but whether dyspnoea by itself negatively impacts on cognition has not been demonstrated. Cortical networks engaged in subjects experiencing dyspnoea are also activated during other tasks that require cognitive input and this may provoke a negative impact through interference with each other.
METHODS


This randomised, crossover trial investigated whether experimentally-induced dyspnoea would negatively impact on locomotion and cognitive function among 40 healthy adults. Crossover conditions were unloaded breathing or loaded breathing using an inspiratory threshold load. To evaluate locomotion, participants were assessed by the Timed Up and Go (TUG) test. Cognitive function was assessed by categorical and phonemic verbal fluency tests, the Trail Making Tests (TMTs) A and B (executive function), the CODE test from the Wechsler Adult Intelligence Scale (WAIS)-IV (processing speed) and by direct and indirect digit span (working memory).
RESULTS


The mean time difference to perform the TUG test between unloaded and loaded breathing was -0.752 s (95% CI -1.012 to -0.492 s) (p<0.001). Executive function, processing speed and working memory performed better during unloaded breathing, particularly for subjects starting first with the loaded breathing condition.
CONCLUSION


Our data suggest that respiratory threshold loading to elicit dyspnoea had a major impact on locomotion and cognitive function in healthy adults.",2020,The mean time difference to perform the Timed Up and Go test between unloaded and loaded breathing was -0.752 s (-1.012 to -0.492,"['healthy adults', '40 healthy adults', 'subjects starting first with the loaded breathing condition', 'subjects experiencing dyspnea']",['unloaded breathing or loaded breathing using an inspiratory threshold load'],"['Executive function, processing speed and working memory', 'mean time difference to perform the Timed Up and Go test between unloaded and loaded breathing', 'locomotion and cognitive function', 'categorical and phonemic verbal fluency tests, the Trail Making Test A and B (executive function), the CODE test from the WAIS-IV (processing speed), and by direct and indirect digit span (working memory', 'Cognitive function']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0023946', 'cui_str': 'Locomotor Activity'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0204456', 'cui_str': 'Wechsler adult intelligence scale'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",40.0,0.0411492,The mean time difference to perform the Timed Up and Go test between unloaded and loaded breathing was -0.752 s (-1.012 to -0.492,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lawi', 'Affiliation': 'Division of Pulmonary Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Dupuis-Lozeron', 'Affiliation': 'Clinical Research Centre and Division of Clinical Epidemiology, Dept of Health and Community Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Berra', 'Affiliation': 'Division of Pulmonary Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Allali', 'Affiliation': 'University of Geneva Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Similowski', 'Affiliation': 'AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Intensive Care Unit and Respiratory Division (Département ""R3S""), Paris, France.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Adler', 'Affiliation': 'Division of Pulmonary Diseases, Geneva University Hospitals, Geneva, Switzerland dan.adler@hcuge.ch.'}]",The European respiratory journal,['10.1183/13993003.00054-2020']
34,32362226,Randomized Trial of a Mobile Personal Health Record for Behavioral Health Homes.,"OBJECTIVE


Behavioral health homes, which provide onsite primary medical care in mental health clinics, face challenges in integrating information across multiple health records. This study tested whether a mobile personal health record application improved quality of medical care for individuals treated in these settings.
METHODS


This randomized study enrolled 311 participants with a serious mental illness and one or more cardiometabolic risk factors across two behavioral health homes to receive a mobile personal health record application (N=156) or usual care (N=155). A secure mobile personal health record (mPHR) app provided participants in the intervention group with key information about diagnoses, medications, and laboratory test values and allowed them to track health goals. The primary study outcome was a chart-derived composite measure of quality of cardiometabolic and preventive services.
RESULTS


At 12-month follow-up, participants in the mPHR group maintained high quality of care (70% of indicated services at baseline and at 12-month follow-up), in contrast to a decline in quality for the usual-care group (71% at baseline and 67% at follow-up), resulting in a statistically significant but clinically modest differential impact between the groups. No differences between the study groups were found in secondary self-reported outcomes, including delivery of chronic illness care, patient activation, and quality of life related to mental or general medical health.
CONCLUSIONS


Use of a mPHR app was associated with a statistically significant but clinically modest differential benefit for quality of medical care among individuals with serious mental illness and comorbid cardiometabolic conditions.",2020,"No differences between the study groups were found in secondary self-reported outcomes, including delivery of chronic illness care, patient activation, and quality of life related to mental or general medical health.
","['individuals treated in these settings', 'Behavioral Health Homes', 'individuals with serious mental illness and comorbid cardiometabolic conditions', '311 participants with a serious mental illness and one or more cardiometabolic risk factors across two behavioral health homes to receive a mobile personal health record application (N=156) or usual care (N=155']","['mobile personal health record application', 'Mobile Personal Health']","['delivery of chronic illness care, patient activation, and quality of life related to mental or general medical health', 'quality of care', 'chart-derived composite measure of quality of cardiometabolic and preventive services', 'quality of medical care']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0018739', 'cui_str': 'Personal Health Records'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0018739', 'cui_str': 'Personal Health Records'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0199175', 'cui_str': 'Preventive service'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]",311.0,0.0822591,"No differences between the study groups were found in secondary self-reported outcomes, including delivery of chronic illness care, patient activation, and quality of life related to mental or general medical health.
","[{'ForeName': 'Benjamin G', 'Initials': 'BG', 'LastName': 'Druss', 'Affiliation': 'Department of Health Policy and Management, Rollins School of Public Health, Emory University, Atlanta.'}, {'ForeName': 'Jianheng', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Health Policy and Management, Rollins School of Public Health, Emory University, Atlanta.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Tapscott', 'Affiliation': 'Department of Health Policy and Management, Rollins School of Public Health, Emory University, Atlanta.'}, {'ForeName': 'Cathy A', 'Initials': 'CA', 'LastName': 'Lally', 'Affiliation': 'Department of Health Policy and Management, Rollins School of Public Health, Emory University, Atlanta.'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201900381']
35,32363552,Influence of the position of the antrostomy in sinus floor elevation on the healing of mini-implants: a randomized clinical trial.,"AIM


To evaluate histologically the healing of mini-implants installed after sinus floor elevation using a lateral approach and placing the antrostomy at different level from the sinus floor.
MATERIAL AND METHODS


Sinus floor elevation using a lateral approach was performed in 24 healthy volunteers. The antrostomy was randomly placed either close to the base of the sinus floor (group base) or at about 3-4 mm cranially to it (group standard). After 6 months of healing, mini-implants were installed within the grafted region, through the alveolar crest. Three months later, biopsies were collected.
RESULTS


Sixteen biopsies from 16 patients were available for histological analyses. The new bone reached fractions of 40.9 ± 11.9% and 48.5 ± 20.1% at the base and standard groups, respectively (p = 0.208). Xenograft particles were found in contact with the implant surface at percentages of 12.1 ± 11.0% in the base group, and 15.9 ± 23.7% in the standard group (p = 0.674).
CONCLUSIONS


Based on the present study, the choice of one or the other position of antrostomy did not influence significantly the outcome and, therefore, should be left to the preference of the surgeon.",2020,"Xenograft particles were found in contact with the implant surface at percentages of 12.1 ± 11.0% in the base group, and 15.9 ± 23.7% in the standard group (p = 0.674).
","['24 healthy volunteers', 'Sixteen biopsies from 16 patients were available for histological analyses']",[],"['Xenograft particles', 'healing of mini-implants']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],"[{'cui': 'C0520484', 'cui_str': 'Xenogeneic transplantation'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]",24.0,0.0279627,"Xenograft particles were found in contact with the implant surface at percentages of 12.1 ± 11.0% in the base group, and 15.9 ± 23.7% in the standard group (p = 0.674).
","[{'ForeName': 'Atsuya', 'Initials': 'A', 'LastName': 'Hirota', 'Affiliation': 'Department of Oral Implantology, Osaka Dental University, Osaka, Japan.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Iezzi', 'Affiliation': 'Dept. of Medical, Oral and Biotechnological Sciences, University of Chieti-Pescara, Chieti, Italy.'}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Piattelli', 'Affiliation': 'Dept. of Medical, Oral and Biotechnological Sciences, University of Chieti-Pescara, Chieti, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Ferri', 'Affiliation': 'Corporación Universitaria Rafael Núñez, Cartagena, Colombia.'}, {'ForeName': 'Kazushige', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of Oral Implantology, Osaka Dental University, Osaka, Japan.'}, {'ForeName': 'Karol Alí', 'Initials': 'KA', 'LastName': 'Apaza Alccayhuaman', 'Affiliation': 'ARDEC Academy, Viale Giovanni Pascoli 67, 47923, Rimini, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Botticelli', 'Affiliation': 'ARDEC Academy, Viale Giovanni Pascoli 67, 47923, Rimini, Italy. daniele.botticelli@gmail.com.'}]",Oral and maxillofacial surgery,['10.1007/s10006-020-00846-7']
36,32371518,Psychiatric hospital reform in low-income and middle-income countries Structured Individualised inTervention And Recovery (SITAR): a two-arm pragmatic randomised controlled trial study protocol.,"INTRODUCTION


Low-income and middle-income settings like India have large treatment gaps in mental healthcare. People with severe mental disorders face impediments to their clinical and functional recovery, and have large unmet needs. The infrastructure and standards of care are poor in colonial period psychiatric hospitals, with no clear pathways to discharge and successfully integrate recovered individuals into the community. Our aim is to study the impact of psychiatric hospital reform on individual patient outcomes in a psychiatric hospital in India.
METHODS AND ANALYSIS


Structured Individualised inTervention And Recovery (SITAR) is a two-arm pragmatic randomised controlled trial, focusing on patients aged 18-60 years with a hospital stay of 12-120 months and a primary diagnosis of psychosis. It tests the effectiveness of structural and process reform with and without an individually tailored recovery plan on patient outcomes of disability (primary outcome WHO Disability Assessment Scale), symptom severity, social and occupational functioning and quality of life. A computer-generated permuted block randomisation schedule will allocate recruited subjects to the two study arms. We aim to recruit 100 people into each trial arm. Baseline and outcome measures will be undertaken by trained researchers independent to the case managers providing the individual intervention. A health economic analysis will determine the costing of implementing the individually tailored recovery plan.
ETHICS AND DISSEMINATION


The study will provide answers to important questions around the nature and process of reforms in institutional care that promote recovery while being cognizant of protecting human rights, and dignity. Ethical approval for SITAR was obtained from a registered ethics committee in India (Institutional Ethics Committee VikasAnvesh Foundation, VAF/2018-19/012 dated 6 December 2018) and the University of Warwick's Biomedical and Scientific Research Ethics Committee (REGO-2019-2332, dated 21 March 2019), and registered on the Central Trial Registry of India (CTRI/2019/01/017267). Trial results will be published in accordance to CONSORT guidelines.",2020,"It tests the effectiveness of structural and process reform with and without an individually tailored recovery plan on patient outcomes of disability (primary outcome WHO Disability Assessment Scale), symptom severity, social and occupational functioning and quality of life.","['People with severe mental disorders', 'patients aged 18-60 years with a hospital stay of 12-120 months and a primary diagnosis of psychosis', '100 people into each trial arm', 'psychiatric hospital in India']",['Individualised inTervention'],"['disability (primary outcome WHO Disability Assessment Scale), symptom severity, social and occupational functioning and quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0020021', 'cui_str': 'Psychiatric hospital'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.266412,"It tests the effectiveness of structural and process reform with and without an individually tailored recovery plan on patient outcomes of disability (primary outcome WHO Disability Assessment Scale), symptom severity, social and occupational functioning and quality of life.","[{'ForeName': 'Tasneem', 'Initials': 'T', 'LastName': 'Raja', 'Affiliation': 'Mental Health, Tata Trusts, Mumbai, India T.Raja@warwick.ac.uk.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Tuomainen', 'Affiliation': ''}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Madan', 'Affiliation': 'Center for Health Economics, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Dipesh', 'Initials': 'D', 'LastName': 'Mistry', 'Affiliation': 'Warwick Cinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Department of Psychiatry, NIMHANS, Bangalore, Karnataka, India.'}, {'ForeName': 'Swaran', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Director, Centre for Mental Health and Wellbeing Research, Warwick Medical School, Coventry, UK.'}]",BMJ open,['10.1136/bmjopen-2019-035753']
37,32371520,"Study protocol for a randomised controlled trial evaluating an evidence-based, stepped and coordinated care service model for mental disorders (RECOVER).","INTRODUCTION


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


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


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


ClinicalTrials.gov (NCT03459664), RECOVER PROTOCOL VERSION: 19 March 2020 (V.3.0).",2020,"As primary outcomes, cost reduction, improvement in symptoms, daily functioning and quality of life as well as cost-effectiveness ratios will be measured.",['890 patients with mental disorders'],[],"['healthcare costs', 'intention-to-treat principle', 'cost reduction, improvement in symptoms, daily functioning and quality of life as well as cost-effectiveness ratios']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]",[],"[{'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",890.0,0.192617,"As primary outcomes, cost reduction, improvement in symptoms, daily functioning and quality of life as well as cost-effectiveness ratios will be measured.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lambert', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany lambert@uke.de.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Karow', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Gallinat', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lüdecke', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Kraft', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Rohenkohl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Romy', 'Initials': 'R', 'LastName': 'Schröter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Constanze', 'Initials': 'C', 'LastName': 'Finter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Anna-Katharina', 'Initials': 'AK', 'LastName': 'Siem', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tlach', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Werkle', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Bargel', 'Affiliation': 'Department of Strategic Business Development, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Gunda', 'Initials': 'G', 'LastName': 'Ohm', 'Affiliation': 'Department of Strategic Business Development, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hoff', 'Affiliation': 'Department of Strategic Business Development, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Peter', 'Affiliation': 'Ambulatory Healthcare Center for Psychotherapy, Psychiatry and Psychosomatic, Cognitive-Behavioral Therapy Falkenried MVZ GmbH, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Scherer', 'Affiliation': 'Department of General Practice/Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Mews', 'Affiliation': 'Department of General Practice/Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Pruskil', 'Affiliation': 'Department of General Practice/Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Lüke', 'Affiliation': 'Department of General Practice/Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Dirmaier', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schulte-Markwort', 'Affiliation': 'Department of Child- and Youth Psychiatry, Psychotherapy and Psychosomatics, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Löwe', 'Affiliation': 'Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Peer', 'Initials': 'P', 'LastName': 'Briken', 'Affiliation': 'Institute for Sex Research, Sexual Medicine and Forensic Psychiatry, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Peper', 'Affiliation': 'Chamber for Psychotherapists Hamburg, Hamburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schweiger', 'Affiliation': 'Service Provider for vocational rehabilitation, ARINET GmbH, Hamburg, Hamburg, Germany.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Mösko', 'Affiliation': 'Department of Medical Psychology, Research Group on Migration and Psychosocial Health, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bock', 'Affiliation': 'Irre Menschlich Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wittzack', 'Affiliation': 'Regional Psychiatric Patient Association Hamburg e.V, Hamburg, Germany.'}, {'ForeName': 'Hans-Jochim', 'Initials': 'HJ', 'LastName': 'Meyer', 'Affiliation': 'Regional Psychiatric Relative Association Hamburg e.V, Hamburg, Germany.'}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'Deister', 'Affiliation': 'Center for Psychosocial Medicine, Klinikum Itzehoe, Itzehoe, Schleswig-Holstein, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Michels', 'Affiliation': 'Center for Psychosocial Medicine, Klinikum Itzehoe, Itzehoe, Schleswig-Holstein, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Herr', 'Affiliation': 'Center for Psychosocial Medicine, Klinikum Itzehoe, Itzehoe, Schleswig-Holstein, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Konnopka', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'König', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Wegscheider', 'Affiliation': 'Institute of Medical Biometry and Epidemiology, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Daubmann', 'Affiliation': 'Institute of Medical Biometry and Epidemiology, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Zapf', 'Affiliation': 'Institute of Medical Biometry and Epidemiology, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Peth', 'Affiliation': 'Department of Medical Psychology, Professorship Clinical Healthcare Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Hans-Helmut', 'Initials': 'HH', 'LastName': 'König', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Schulz', 'Affiliation': 'Department of Medical Psychology, Professorship Clinical Healthcare Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-036021']
38,32375348,Influence of Sunlight and Oral D 3  Supplementation on Serum 25(OH)D Concentration and Exercise Performance in Elite Soccer Players.,"The aim of this study was to evaluate the influence of natural sun exposure and six weeks of a high dose of vitamin D supplementation on vitamin D, testosterone and cortisol serum concentrations as well as speed, power and VO 2max  in professional soccer players.
MATERIALS


The study was conducted from January to September. At the beginning of the study, 33 professional soccer players were enrolled; however, only 28 subjects (height 181.5 cm; body mass 77.81 ± 8.8 kg; body fat 12.38% ± 2.4% and muscle mass 40.27 ± 5.3 kg) completed the study. The research consisted of three stages. The first one, lasting 10 days, was conducted in January during a training camp in the south part of Cyprus at a latitude of 34 33°, where participants experienced natural sun exposure; it was called a winter sun exposure (WSE) period. The second stage, which was a supplementation period (SP), lasted 6 weeks, during which all subjects were randomly assigned either to an experimental group-EG ( n  = 15)-or a placebo group-PG ( n  = 13)-and were administered 6000 IU/d cholecalciferol or a placebo, respectively. The third stage took place in September, after summertime (summer sun exposure-SSE). The data of the 25(OH)D, free and total testosterone (fT, tT), cortisol as well as 5 and 30 m sprint tests (STs), power of the left leg (PLL) and VO 2max  were evaluated before and after the WSE period, the SP and SSE.
RESULTS


In January, the baseline value of vitamin D in 12 subjects was ≤20 ng/mL, and 14 of them had levels between 20-30 ng/mL and 2 individuals >30 ng/mL. After the WSE period, significant changes in 25(OH)D, fT, tT and cortisol concentration, as well as in the 5 m ST, were observed. After the SP, in the EG, significant changes were found in 25(OH)D, fT, tT and the 5 m ST. Furthermore, a positive correlation between the concentration of 25(OH) fT and tT was observed. After SSE, 2 out of 28 players had <20 ng/mL 25(OH)D, 12 of them had 25(OH)D between 20 and 30 ng/mL and 14 of them had 25(OH)D between 30 and 50 ng/mL. Significant differences in 25(OH)D, fT, tT concentration and the 5 m ST performance were observed following SSE compared with the WSE period.
CONCLUSION


Due to the serum level of 25(OH)D demonstrated by most participants at the beginning of the study and after summertime, all-year-round supplementation with high doses of vitamin D seems to be a reasonable solution to enhance high 25(OH)D concentration in blood and physical performance. In the middle of the winter, almost half of the soccer players were serum deficient of 25(OH)D. After ten days of sun exposure and 6 weeks of vitamin D supplementation, the concentration of 25(OH)D significantly increased, as did testosterone and results in the 5 m sprint test also improved. Therefore, athletes should be constantly monitored for serum levels of 25(OH)D throughout the year and should be supplemented if deficiencies or insufficient amounts of this vitamin occur.",2020,"ng/mL. Significant differences in 25(OH)D, fT, tT concentration and the 5 m ST performance were observed following SSE compared with the WSE period.
","['33 professional soccer players were enrolled; however, only 28 subjects (height 181.5 cm; body mass 77.81 ± 8.8 kg; body fat 12.38% ± 2.4% and muscle mass 40.27 ± 5.3 kg) completed the study', 'between 30 and 50', 'Elite Soccer Players', 'professional soccer players']","['Sunlight and Oral D 3  Supplementation', 'cholecalciferol or a placebo', 'vitamin D', 'vitamin D supplementation', 'placebo']","['Serum 25(OH)D Concentration and Exercise Performance', '25(OH)D, fT, tT and cortisol concentration', 'vitamin D, testosterone and cortisol serum concentrations as well as speed, power and VO 2max', 'free and total testosterone (fT, tT), cortisol as well as 5 and 30 m sprint tests (STs), power of the left leg (PLL) and VO 2max', 'concentration of 25(OH)D', 'serum deficient of 25(OH)D', 'concentration of 25(OH', '25(OH)D, fT, tT concentration and the 5 m ST performance']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0729349', 'cui_str': 'Serum cortisol'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0230443', 'cui_str': 'Structure of left lower leg'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}]",33.0,0.0780611,"ng/mL. Significant differences in 25(OH)D, fT, tT concentration and the 5 m ST performance were observed following SSE compared with the WSE period.
","[{'ForeName': 'Małgorzata Magdalena', 'Initials': 'MM', 'LastName': 'Michalczyk', 'Affiliation': 'Institute of Sport Sciences The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland Mikolowska 72a, 40-065 Katowice, Poland.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Gołaś', 'Affiliation': 'Institute of Sport Sciences The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland Mikolowska 72a, 40-065 Katowice, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Maszczyk', 'Affiliation': 'Institute of Sport Sciences The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland Mikolowska 72a, 40-065 Katowice, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Kaczka', 'Affiliation': 'Research and Development Center, Olimp Laboratories Sp. z o.o, 39-200 Dębica, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Zając', 'Affiliation': 'Institute of Sport Sciences The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland Mikolowska 72a, 40-065 Katowice, Poland.'}]",Nutrients,['10.3390/nu12051311']
39,32377858,High definition three-dimensional exoscope (VITOM 3D) for microsurgery training: a preliminary experience.,"PURPOSE


To assess the feasibility of a high definition 3D exoscope (VITOM ® ) for microsurgery training in a cohort of naïve medical students.
METHODS


Twenty-two consecutive medical students performed a battery of four exercises assessing basic microsurgical skills. The students were randomized in two different groups based on two different VITOM ®  holding systems (VERSACRANE™ and ARTip™ cruise). Participants self-reported the VITOM ®  system quality on a 4-point Likert scale (VITOM Quality Assessment Tool). The time needed to complete the exercises was analyzed.
RESULTS


All students successfully completed the training, and no technical issues were raised during the simulation. The majority of the individual items were judged ""good"" or ""very good"" (n = 187; 94.4%), regardless of the two groups. ""Image quality"" (n = 21; 95%), ""magnification rate"" (n = 20; 91%), ""stereoscopic effect"" (n = 19; 86%), and ""focusing"" (n = 18; 82%) represented the best-rated items. No statistically significant difference between the two groups was measured in almost all items of the VITOM Quality Assessment Tool (p > 0.05). The time needed to perform each exercise showed a statistically significant difference between groups in two tests (p < 0.05).
CONCLUSION


This study demonstrated the feasibility of a VITOM-based microsurgery training. The students' subjective assessment of the VITOM ®  3D system was promising in terms of technological quality and technical feasibility. Further studies are recommended to define which VITOM ®  holding system could be more appropriate for microsurgery training.",2020,The students' subjective assessment of the VITOM ®  3D system was promising in terms of technological quality and technical feasibility.,"['microsurgery training in a cohort of naïve medical students', 'Twenty-two consecutive medical students']","['four exercises assessing basic microsurgical skills', 'VITOM-based microsurgery training', 'high definition 3D exoscope (VITOM ® ']","['time needed to perform each exercise', 'VITOM ®  system quality on a 4-point Likert scale (VITOM Quality Assessment Tool', 'magnification rate', 'VITOM Quality Assessment Tool']","[{'cui': 'C0026035', 'cui_str': 'Microsurgery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C4284772', 'cui_str': '22'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026035', 'cui_str': 'Microsurgery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]",22.0,0.0174803,The students' subjective assessment of the VITOM ®  3D system was promising in terms of technological quality and technical feasibility.,"[{'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'De Virgilio', 'Affiliation': 'Otorhinolaryngology Unit, IRCCS Humanitas Clinical and Research Center, Via Manzoni 56, 20089, Rozzano, MI, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Costantino', 'Affiliation': 'Otorhinolaryngology Unit, IRCCS Humanitas Clinical and Research Center, Via Manzoni 56, 20089, Rozzano, MI, Italy. andrea.costantino94@gmail.com.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Ebm', 'Affiliation': 'Simulation Center, Humanitas University, Via Rita Levi Montalcini, 4, 20090, Pieve Emanuele, MI, Italy.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Conti', 'Affiliation': 'Otorhinolaryngology Unit, IRCCS Humanitas Clinical and Research Center, Via Manzoni 56, 20089, Rozzano, MI, Italy.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Mondello', 'Affiliation': 'Otorhinolaryngology Unit, IRCCS Humanitas Clinical and Research Center, Via Manzoni 56, 20089, Rozzano, MI, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Di Bari', 'Affiliation': 'Otorhinolaryngology Unit, IRCCS Humanitas Clinical and Research Center, Via Manzoni 56, 20089, Rozzano, MI, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Cugini', 'Affiliation': 'Otorhinolaryngology Unit, IRCCS Humanitas Clinical and Research Center, Via Manzoni 56, 20089, Rozzano, MI, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Mercante', 'Affiliation': 'Otorhinolaryngology Unit, IRCCS Humanitas Clinical and Research Center, Via Manzoni 56, 20089, Rozzano, MI, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Spriano', 'Affiliation': 'Otorhinolaryngology Unit, IRCCS Humanitas Clinical and Research Center, Via Manzoni 56, 20089, Rozzano, MI, Italy.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06014-7']
40,32383271,Acute effects of cannabinoids on symptoms of obsessive-compulsive disorder: A human laboratory study.,"BACKGROUND


Preclinical data implicate the endocannabinoid system in the pathology underlying obsessive-compulsive disorder (OCD), while survey data have linked OCD symptoms to increased cannabis use. Cannabis products are increasingly marketed as treatments for anxiety and other OCD-related symptoms. Yet, few studies have tested the acute effects of cannabis on psychiatric symptoms in humans.
METHODS


We recruited 14 adults with OCD and prior experience using cannabis to enter a randomized, placebo-controlled, human laboratory study to compare the effects on OCD symptoms of cannabis containing varying concentrations of Δ-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) on OCD symptoms to placebo. We used a within-subjects design to increase statistical power. Across three laboratory sessions, participants smoked three cannabis varietals in random order: placebo (0% THC/0% CBD); THC (7.0% THC/0.18% CBD); and CBD (0.4% THC/10.4% CBD). We analyzed acute changes in OCD symptoms, state anxiety, cardiovascular measures, and drug-related effects (e.g., euphoria) as a function of varietal.
RESULTS


Twelve participants completed the study. THC increased heart rate, blood pressure, and intoxication compared with CBD and placebo. Self-reported OCD symptoms and anxiety decreased over time in all three conditions. Although OCD symptoms did not vary as a function of cannabis varietal, state anxiety was significantly lower immediately after placebo administration relative to both THC and CBD.
CONCLUSIONS


This is the first placebo-controlled investigation of cannabis in adults with OCD. The data suggest that smoked cannabis, whether containing primarily THC or CBD, has little acute impact on OCD symptoms and yields smaller reductions in anxiety compared to placebo.",2020,"Although OCD symptoms did not vary as a function of cannabis varietal, state anxiety was significantly lower immediately after placebo administration relative to both THC and CBD.
","['Twelve participants completed the study', 'adults with OCD', '14 adults with OCD and prior experience using cannabis to enter a randomized']","['cannabinoids', 'placebo']","['symptoms of obsessive-compulsive disorder', 'Self-reported OCD symptoms and anxiety', 'heart rate, blood pressure, and intoxication', 'OCD symptoms of cannabis containing varying concentrations of Δ-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) on OCD symptoms', 'CBD', 'function of cannabis varietal, state anxiety', 'OCD symptoms, state anxiety, cardiovascular measures, and drug-related effects (e.g., euphoria']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}]","[{'cui': 'C0006864', 'cui_str': 'cannabinoids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0199659', 'cui_str': 'Cardiovascular measure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0235146', 'cui_str': 'Euphoria'}]",14.0,0.24613,"Although OCD symptoms did not vary as a function of cannabis varietal, state anxiety was significantly lower immediately after placebo administration relative to both THC and CBD.
","[{'ForeName': 'Reilly R', 'Initials': 'RR', 'LastName': 'Kayser', 'Affiliation': 'Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, New York.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Haney', 'Affiliation': 'Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, New York.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Raskin', 'Affiliation': 'Office of Mental Health, Research Foundation for Mental Hygiene, New York State Psychiatric Institute, New York, New York.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Arout', 'Affiliation': 'Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, New York.'}, {'ForeName': 'Helen Blair', 'Initials': 'HB', 'LastName': 'Simpson', 'Affiliation': 'Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, New York.'}]",Depression and anxiety,['10.1002/da.23032']
41,32361951,Once-yearly zoledronic acid and change in abdominal aortic calcification over 3 years in postmenopausal women with osteoporosis: results from the HORIZON Pivotal Fracture Trial.,"This study evaluated whether zoledronic acid (ZA) inhibited the progression of abdominal aortic calcification (AAC) over 3 years in 502 postmenopausal women with osteoporosis. AAC progressed in a similar proportion of participants in the ZA (29%) and placebo (31%) groups, suggesting no effect of ZA on AAC progression.
INTRODUCTION


Bisphosphonate use is associated with reduced risk of all-cause mortality and cardiovascular events. The underlying mechanisms are uncertain but may include effects on vascular calcification. This study aimed to evaluate the effect of zoledronic acid (ZA) on abdominal aortic calcification (AAC) in postmenopausal women with osteoporosis.
METHODS


This was a post hoc analysis of the HORIZON Pivotal Fracture Trial that included 502 postmenopausal women (mean age 72.5 years) with osteoporosis (234 received ZA and 268 placebo). AAC scores (range, 0-8) were assessed from paired spine X-rays at baseline and after 3 years. Progression of AAC was defined as any increase in AAC score. The association between change in hip and femoral neck bone mineral density and change in AAC score was also assessed.
RESULTS


At baseline, 292 (58.2%) participants had AAC (i.e., AAC score > 0), with AAC scores similar in the two intervention groups (median [interquartile range], 1 [0 to 2] for both; p = 0.98). Over 3 years, AAC progressed in a similar proportion of participants in both groups (ZA 29% and placebo 31%; p = 0.64). Change in bone mineral density and change in AAC score were not correlated.
CONCLUSION


Once-yearly zoledronic acid did not affect progression of AAC over 3 years in postmenopausal women with osteoporosis.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT00049829.",2020,"AAC progressed in a similar proportion of participants in the ZA (29%) and placebo (31%) groups, suggesting no effect of ZA on AAC progression.
","['postmenopausal women with osteoporosis', '502 postmenopausal women with osteoporosis', '502 postmenopausal women (mean age 72.5\xa0years) with osteoporosis (234 received ZA and 268 placebo']","['placebo', 'Bisphosphonate', 'zoledronic acid', 'zoledronic acid (ZA']","['progression of abdominal aortic calcification (AAC', 'AAC scores', 'abdominal aortic calcification', 'hip and femoral neck bone mineral density and change in AAC score', 'bone mineral density and change in AAC score', 'Progression of AAC', 'AAC score', 'progression of AAC', 'abdominal aortic calcification (AAC', 'AAC']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C1096249', 'cui_str': 'Aortic calcification'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",502.0,0.34806,"AAC progressed in a similar proportion of participants in the ZA (29%) and placebo (31%) groups, suggesting no effect of ZA on AAC progression.
","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Cai', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Private Bag 23, Hobart, Tasmania, 7000, Australia.'}, {'ForeName': 'H I', 'Initials': 'HI', 'LastName': 'Keen', 'Affiliation': 'Department of Rheumatology, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'L V', 'Initials': 'LV', 'LastName': 'Host', 'Affiliation': 'Department of Rheumatology, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Aitken', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Private Bag 23, Hobart, Tasmania, 7000, Australia.'}, {'ForeName': 'L L', 'Initials': 'LL', 'LastName': 'Laslett', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Private Bag 23, Hobart, Tasmania, 7000, Australia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Winzenberg', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Private Bag 23, Hobart, Tasmania, 7000, Australia.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Wluka', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Alfred Hospital, Monash University, Melbourne, Australia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Black', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Jones', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Private Bag 23, Hobart, Tasmania, 7000, Australia. Graeme.Jones@utas.edu.au.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05430-z']
42,32365849,Intake of Alpha-Linolenic Acid-Rich  Perilla frutescens  Leaf Powder Decreases Home Blood Pressure and Serum Oxidized Low-Density Lipoprotein in Japanese Adults.,"Oxidized low-density lipoprotein (Ox-LDL) is known to be highly atherogenic. Thus, decreasing the blood levels of Ox-LDL through dietary means is an important approach to reduce cardiovascular events in high-risk individuals. In this randomized placebo-controlled human interventional trial, we aimed to evaluate whether  Perilla frutescens  leaf powder (PLP) ameliorates Ox-LDL and home blood pressure, along with its biological antioxidant potential. Healthy Japanese volunteers aged 30-60 years ( n  = 60) were randomized to PLP and placebo groups. The PLP group consumed PLP dried using a microwave under reduced pressure, and the placebo group consumed pectin fiber daily for 6 months. Home blood pressure, serum biochemical parameters, and fatty acid profiles of erythrocyte plasma membranes were analyzed. Plasma Ox-LDL levels significantly decreased in the PLP group but not in the placebo group. Mean changes in the biological antioxidant potential and alpha-linolenic acid levels in the erythrocyte plasma membrane were significantly increased in the PLP group than in the placebo group. In subjects with prehypertension (systolic blood pressure [SBP] ³ 120 mmHg), the mean reduction in morning or nocturnal SBP was significantly greater in the PLP group than in the placebo group. Thus, PLP intake may be an effective intervention to prevent cardiovascular diseases.",2020,Mean changes in the biological antioxidant potential and alpha-linolenic acid levels in the erythrocyte plasma membrane were significantly increased in the PLP group than in the placebo group.,"['subjects with prehypertension (systolic blood pressure [SBP] ³ 120 mmHg', 'Healthy Japanese volunteers aged 30-60 years ( n  = 60', 'Japanese Adults']","['PLP and placebo', 'Oxidized low-density lipoprotein (Ox-LDL', 'Perilla frutescens  leaf powder (PLP', 'placebo']","['erythrocyte plasma membrane', 'Home blood pressure, serum biochemical parameters, and fatty acid profiles of erythrocyte plasma membranes', 'blood levels', 'Plasma Ox-LDL levels', 'biological antioxidant potential and alpha-linolenic acid levels', 'mean reduction in morning or nocturnal SBP']","[{'cui': 'C1696708', 'cui_str': 'Prehypertension'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0034266', 'cui_str': 'pyridoxal phosphate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0331304', 'cui_str': 'Perilla frutescens'}, {'cui': 'C0242724', 'cui_str': 'Leaves'}, {'cui': 'C0032861', 'cui_str': 'Powder'}]","[{'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0007603', 'cui_str': 'Cell membrane'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C4049351', 'cui_str': 'Biological antioxidant potential'}, {'cui': 'C0051405', 'cui_str': 'alpha-Linolenic Acid'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}]",60.0,0.141202,Mean changes in the biological antioxidant potential and alpha-linolenic acid levels in the erythrocyte plasma membrane were significantly increased in the PLP group than in the placebo group.,"[{'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Environmental Physiology, Shimane University Faculty of Medicine, Izumo-693-8501, Shimane, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Tanabe', 'Affiliation': 'Department of Environmental Physiology, Shimane University Faculty of Medicine, Izumo-693-8501, Shimane, Japan.'}, {'ForeName': 'Shahdat', 'Initials': 'S', 'LastName': 'Hossain', 'Affiliation': 'Department of Biochemistry and Molecular Biology, Jahangirnagar University, Savar, Dhaka-1342, Bangladesh.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Matsuzaki', 'Affiliation': 'Department of Environmental Physiology, Shimane University Faculty of Medicine, Izumo-693-8501, Shimane, Japan.'}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Ohno', 'Affiliation': 'Kato Hospital, Jinjukai Healthcare Corporation, Kawamoto, Shimane, Japan.'}, {'ForeName': 'Setsushi', 'Initials': 'S', 'LastName': 'Kato', 'Affiliation': 'Kato Hospital, Jinjukai Healthcare Corporation, Kawamoto, Shimane, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Katakura', 'Affiliation': 'Department of Environmental Physiology, Shimane University Faculty of Medicine, Izumo-693-8501, Shimane, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Shido', 'Affiliation': 'Department of Environmental Physiology, Shimane University Faculty of Medicine, Izumo-693-8501, Shimane, Japan.'}]","Molecules (Basel, Switzerland)",['10.3390/molecules25092099']
43,32362552,"Comparing the Efficacy of Bevacizumab and Ranibizumab in Patients with Diabetic Macular Edema (BRDME): The BRDME Study, a Randomized Trial.","PURPOSE


To generate conclusive evidence regarding the noninferiority of intravitreal bevacizumab compared with ranibizumab in patients with diabetic macular edema (DME).
DESIGN


Comparative, randomized, double-masked, multicenter, noninferiority clinical trial.
PARTICIPANTS


Eligible patients were older than 18 years, diagnosed with type 1 or type 2 diabetes mellitus, with glycosylated hemoglobin of less than 12%, central area thickness of more than 325 μm, and visual impairment from DME with a best-corrected visual acuity (BCVA) between 24 letters and 78 letters.
METHODS


From June 2012 through February 2018, a total of 170 participants were randomized to receive 6 monthly injections of either 1.25 mg bevacizumab (n = 86) or 0.5 mg ranibizumab (n = 84).
MAIN OUTCOME MEASURES


Primary outcome was change in BCVA from baseline to month 6 compared between the 2 treatment arms. The noninferiority margin was 3.5 letters.
RESULTS


The difference in mean BCVA between treatment arms was 1.8 letters in favor of ranibizumab after 6 months of follow-up; BCVA improved by 4.9±6.7 letters in the bevacizumab group and 6.7±8.7 letters in the ranibizumab group. The lower bound of the 2-sided 90% confidence interval (CI) was -3.626 letters, exceeding the noninferiority margin of 3.5 letters. Central area thickness decreased more with ranibizumab (138.2±114.3 μm) compared with bevacizumab (64.2±104.2 μm). In a post hoc subgroup analysis, participants with a worse BCVA at baseline (≤69 letters) improved by 6.7±7.0 letters with bevacizumab and 10.4±10.0 letters with ranibizumab, and central area thickness decreased significantly more in the ranibizumab arm of this subgroup compared with the bevacizumab arm. Participants with an initially better BCVA at baseline (≥70 letters) did not demonstrate differences in BCVA or OCT outcomes between treatment arms.
CONCLUSIONS


Based on change in BCVA from baseline to month 6, the noninferiority of 1.25 mg bevacizumab to 0.5 mg ranibizumab was not confirmed. Only the subgroup of patients with a lower BCVA at baseline showed better visual acuity and anatomic outcomes with ranibizumab. Our study confirmed the potential differential efficacy of anti-vascular endothelial growth factor agents in the treatment of DME as well as the difference in response between patient groups with different baseline visual acuities.",2020,Central area thickness decreased more with ranibizumab (138.2±114.3 μm) compared with bevacizumab (64.2±104.2 μm).,"['From June 2012 through February 2018, a total of 170 participants', 'patients with diabetic macular edema (DME', 'Patients with Diabetic Macular Edema (BRDME', 'Eligible patients were older than 18 years, diagnosed with type 1 or type 2 diabetes mellitus, with glycosylated hemoglobin of less than 12%, central area thickness of more than 325 μm, and visual impairment from DME with a best-corrected visual acuity (BCVA) between 24 letters and 78 letters']","['anti-vascular endothelial growth factor agents', 'Bevacizumab and\xa0Ranibizumab', 'ranibizumab', 'bevacizumab']","['mean BCVA', 'central area thickness', 'change in BCVA', 'visual acuity and anatomic outcomes', 'BCVA or OCT outcomes', 'Central area thickness', 'BCVA']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0017853', 'cui_str': 'Glycosylated hemoglobin'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0042798', 'cui_str': 'Dim vision'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}]",170.0,0.494608,Central area thickness decreased more with ranibizumab (138.2±114.3 μm) compared with bevacizumab (64.2±104.2 μm).,"[{'ForeName': 'Maartje J C', 'Initials': 'MJC', 'LastName': 'Vader', 'Affiliation': 'Department of Ophthalmology, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ann-Sofie M E', 'Initials': 'AME', 'LastName': 'Schauwvlieghe', 'Affiliation': 'Department of Ophthalmology, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Frank D', 'Initials': 'FD', 'LastName': 'Verbraak', 'Affiliation': 'Department of Ophthalmology, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Greetje', 'Initials': 'G', 'LastName': 'Dijkman', 'Affiliation': 'Department of Ophthalmology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Johanna M M', 'Initials': 'JMM', 'LastName': 'Hooymans', 'Affiliation': 'Department of Ophthalmology, University Medical Center Groningen and W. J. Kolff Institute, Graduate School of Medical Sciences, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Leonoor I', 'Initials': 'LI', 'LastName': 'Los', 'Affiliation': 'Department of Ophthalmology, University Medical Center Groningen and W. J. Kolff Institute, Graduate School of Medical Sciences, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Aeilko H', 'Initials': 'AH', 'LastName': 'Zwinderman', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Tunde', 'Initials': 'T', 'LastName': 'Peto', 'Affiliation': 'Department of Ophthalmology, Queens University Belfast, Belfast, United Kingdom.'}, {'ForeName': 'Carel B', 'Initials': 'CB', 'LastName': 'Hoyng', 'Affiliation': 'Department of Ophthalmology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Redmer', 'Initials': 'R', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Ophthalmology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Johannes R', 'Initials': 'JR', 'LastName': 'Vingerling', 'Affiliation': 'Department of Ophthalmology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Annette C', 'Initials': 'AC', 'LastName': 'Moll', 'Affiliation': 'Department of Ophthalmology, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Janneke J C', 'Initials': 'JJC', 'LastName': 'van Lith-Verhoeven', 'Affiliation': 'Department of Ophthalmology, Elisabeth-TweeSteden (ETZ) Hospital, Tilburg, The Netherlands.'}, {'ForeName': 'Marcel G W', 'Initials': 'MGW', 'LastName': 'Dijkgraaf', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Reinier O', 'Initials': 'RO', 'LastName': 'Schlingemann', 'Affiliation': 'Department of Ophthalmology, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands; Department of Ophthalmology, University of Lausanne, Jules-Gonin Eye Hospital, Lausanne, Switzerland. Electronic address: r.o.schlingemann@amsterdamumc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology. Retina,['10.1016/j.oret.2020.02.008']
44,32363743,Positive association of serum uric acid with new-onset diabetes in Chinese women with hypertension in a retrospective analysis of the China Stroke Primary Prevention Trial.,"AIMS


To investigate the association of baseline serum uric acid (UA) with new-onset diabetes, and to explore the possible effect modifiers in Chinese adults with hypertension.
MATERIALS AND METHODS


A total of 14 943 hypertensive patients with available UA measurements and without diabetes at baseline were included from the China Stroke Primary Prevention Trial (CSPPT). Participants were randomly assigned to a double-blind daily treatment with 10 mg enalapril and 0.8 mg folic acid or 10 mg enalapril alone. The primary outcome was new-onset diabetes, defined as physician-diagnosed diabetes or use of glucose-lowering drugs during follow-up, or fasting glucose ≥7.0 mmol/L at the exit visit.
RESULTS


Over a median follow-up of 4.5 years, 1623 participants (10.9%) developed diabetes. Overall, there was a positive association between baseline UA and new-onset diabetes in women (per SD increment; adjusted odds ratio [OR] 1.14, 95% confidence interval [CI] 1.07, 1.23), but not in men (adjusted OR 1.01, 95% CI 0.92, 1.10). Moreover, a stronger positive association between baseline UA and new-onset diabetes was found among women with lower time-averaged on-treatment systolic blood pressure during the treatment period (<140 vs. ≥140 mmHg; P-interaction = 0.024), higher baseline body mass index (<24 vs. ≥24 kg/m 2  ; P-interaction = 0.012), or higher baseline waist circumference (<80 vs. ≥80 cm; P-interaction = 0.032).
CONCLUSIONS


Our study suggested that higher baseline UA was significantly associated with increased risk of new-onset diabetes in hypertensive Chinese women, but not in men. Further prospective studies are required to validate the differential association by sex.",2020,"<24 vs. ≥24 kg/m 2  ; P-interaction = 0.012), or higher baseline waist circumference (WC) (<80 vs. ≥80 cm; P-interaction = 0.032).
","['participants with different characteristics', 'A total 14\u2009943 hypertensive patients with available UA measurements and without diabetes at baseline were included from the China Stroke Primary Prevention Trial (CSPPT', 'hypertensive Chinese adults', 'hypertensive Chinese females']",['enalapril and 0.8\u2009mg folic acid or 10\u2009mg enalapril alone'],"['risk of new-onset diabetes', 'diabetes', 'new-onset diabetes, defined as physician-diagnosed diabetes or use of glucose-lowering drugs during follow-up, or fasting glucose ≥7.0\u2009mmol/L at the exit visit', 'baseline serum uric acid (UA) and new-onset diabetes', 'baseline UA and new-onset diabetes']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0337094', 'cui_str': 'Exit'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}]",14943.0,0.181051,"<24 vs. ≥24 kg/m 2  ; P-interaction = 0.012), or higher baseline waist circumference (WC) (<80 vs. ≥80 cm; P-interaction = 0.032).
","[{'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Division of Nephrology, National Clinical Research Centre for Kidney Disease, State Key Laboratory for Organ Failure Research, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Mengyi', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Division of Nephrology, National Clinical Research Centre for Kidney Disease, State Key Laboratory for Organ Failure Research, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Zhuxian', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Division of Nephrology, National Clinical Research Centre for Kidney Disease, State Key Laboratory for Organ Failure Research, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Division of Nephrology, National Clinical Research Centre for Kidney Disease, State Key Laboratory for Organ Failure Research, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Nie', 'Affiliation': 'Division of Nephrology, National Clinical Research Centre for Kidney Disease, State Key Laboratory for Organ Failure Research, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Liang', 'Affiliation': 'Division of Nephrology, National Clinical Research Centre for Kidney Disease, State Key Laboratory for Organ Failure Research, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Chengzhang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Shenzhen Evergreen Medical Institute, Shenzhen, China.'}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'Department of Cardiology, Loudi Central Hospital, Loudi, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Beijing Advanced Innovation Centre for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, China.'}, {'ForeName': 'Lishun', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Beijing Advanced Innovation Centre for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, China.'}, {'ForeName': 'Binyan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Shenzhen Evergreen Medical Institute, Shenzhen, China.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Xiping', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Division of Nephrology, National Clinical Research Centre for Kidney Disease, State Key Laboratory for Organ Failure Research, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Division of Nephrology, National Clinical Research Centre for Kidney Disease, State Key Laboratory for Organ Failure Research, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14072']
45,32372182,Lumboperitoneal shunt in idiopathic normal pressure hydrocephalus: a prospective controlled study.,"OBJECTIVE


In this prospective, controlled, monocentric study, we described the clinical and neuroimaging 12-month follow-up of two parallel cohorts of subjects with idiopathic normal pressure hydrocephalus (iNPH), who did or did not undergo lumboperitoneal shunt (LPS).
METHODS


We recruited 78 iNPH patients. At baseline, subjects underwent clinical and neuropsychological assessments, 3 T magnetic resonance imaging (MRI), and tap test. After baseline, 44 patients (LPS group) opted for LPS implantation, whereas 34 subjects (control group) declined surgery. Both cohorts were then followed up for 12 months through scheduled clinical and neuropsychological evaluations every 6 months. 3 T MRI was repeated at 12-month follow-up.
RESULTS


Gait, balance, and urinary continence improved in the LPS group, without significant influence on cognitive functions. Conversely, gait and urinary continence worsened in the control group. No preoperative MRI parameter was significant outcome predictor after LPS. Of relevance, in responders to LPS, we found postoperative reduction of periventricular white matter (PWM) hyperintensities, which were instead increased in the control group.
CONCLUSIONS


LPS is safe and effective in iNPH. An early surgical treatment is desirable to prevent clinical worsening. Post-surgery decrease of PWM hyperintensities may be a useful MRI marker surrogate for clinical effectiveness of LPS.",2020,"RESULTS


Gait, balance, and urinary continence improved in the LPS group, without significant influence on cognitive functions.","['idiopathic normal pressure hydrocephalus', '78 iNPH patients', 'subjects with idiopathic normal pressure hydrocephalus (iNPH), who did or did not undergo lumboperitoneal shunt (LPS', '44 patients (LPS group) opted for']","['Lumboperitoneal shunt', 'LPS implantation', 'LPS']","['postoperative reduction of periventricular white matter (PWM) hyperintensities', 'PWM hyperintensities', 'Gait, balance, and urinary continence', 'cognitive functions', 'gait and urinary continence']","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0020258', 'cui_str': 'Normal pressure hydrocephalus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1112158', 'cui_str': 'Lumboperitoneal shunt'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1112158', 'cui_str': 'Lumboperitoneal shunt'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0228157', 'cui_str': 'Periventricular white matter'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0542565', 'cui_str': 'Bladder control'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",78.0,0.0302809,"RESULTS


Gait, balance, and urinary continence improved in the LPS group, without significant influence on cognitive functions.","[{'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Todisco', 'Affiliation': ""Parkinson's Disease and Movement Disorders Unit, IRCCS Mondino Foundation, Via Mondino 2, 27100, Pavia, Italy.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Picascia', 'Affiliation': ""Alzheimer's Disease Assessment Unit/Laboratory of Neuropsychology, IRCCS Mondino Foundation, Pavia, Italy.""}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Pisano', 'Affiliation': 'Neurosurgery Unit, IRCCS San Matteo Foundation, Pavia, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Zangaglia', 'Affiliation': ""Parkinson's Disease and Movement Disorders Unit, IRCCS Mondino Foundation, Via Mondino 2, 27100, Pavia, Italy.""}, {'ForeName': 'Brigida', 'Initials': 'B', 'LastName': 'Minafra', 'Affiliation': ""Parkinson's Disease and Movement Disorders Unit, IRCCS Mondino Foundation, Via Mondino 2, 27100, Pavia, Italy.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Vitali', 'Affiliation': 'Neuroradiology Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Rognone', 'Affiliation': 'Neuroradiology Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pichiecchio', 'Affiliation': 'Neuroradiology Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Ceravolo', 'Affiliation': 'Unit of Neurology, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Vanacore', 'Affiliation': 'National Centre for Disease Prevention and Health Promotion, National Institute of Health, Rome, Italy.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Fasano', 'Affiliation': ""Morton and Gloria Shulman Movement Disorders Centre and the Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital, University Health Network, Toronto, ON, Canada.""}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Pacchetti', 'Affiliation': ""Parkinson's Disease and Movement Disorders Unit, IRCCS Mondino Foundation, Via Mondino 2, 27100, Pavia, Italy. claudio.pacchetti@mondino.it.""}]",Journal of neurology,['10.1007/s00415-020-09844-x']
46,32382082,High-risk additional chromosomal abnormalities at low blast counts herald death by CML.,"Blast crisis is one of the remaining challenges in chronic myeloid leukemia (CML). Whether additional chromosomal abnormalities (ACAs) enable an earlier recognition of imminent blastic proliferation and a timelier change of treatment is unknown. One thousand five hundred and ten imatinib-treated patients with Philadelphia-chromosome-positive (Ph+) CML randomized in CML-study IV were analyzed for ACA/Ph+ and blast increase. By impact on survival, ACAs were grouped into high risk (+8, +Ph, i(17q), +17, +19, +21, 3q26.2, 11q23, -7/7q abnormalities; complex) and low risk (all other). The presence of high- and low-risk ACAs was linked to six cohorts with different blast levels (1%, 5%, 10%, 15%, 20%, and 30%) in a Cox model. One hundred and twenty-three patients displayed ACA/Ph+ (8.1%), 91 were high risk. At low blast levels (1-15%), high-risk ACA showed an increased hazard to die compared to no ACA (ratios: 3.65 in blood; 6.12 in marrow) in contrast to low-risk ACA. No effect was observed at blast levels of 20-30%. Sixty-three patients with high-risk ACA (69%) died (n = 37) or were alive after progression or progression-related transplantation (n = 26). High-risk ACA at low blast counts identify end-phase CML earlier than current diagnostic systems. Mortality was lower with earlier treatment. Cytogenetic monitoring is indicated when signs of progression surface or response to therapy is unsatisfactory.",2020,"At low blast levels (1-15%), high-risk ACA showed an increased hazard to die compared to no ACA (ratios: 3.65 in blood; 6.12 in marrow) in contrast to low-risk ACA.","['chronic myeloid leukemia (CML', 'Sixty-three patients with high-risk ACA (69%) died (n\u2009=\u200937) or were alive after progression or progression-related transplantation (n\u2009=\u200926', 'One thousand five hundred and ten imatinib-treated patients with Philadelphia-chromosome-positive (Ph+) CML randomized in CML-study IV']",[],"['Mortality', 'survival, ACAs']","[{'cui': 'C0023473', 'cui_str': 'Chronic myeloid leukemia'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0149561', 'cui_str': 'Structure of anterior cerebral artery'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0856536', 'cui_str': 'Philadelphia chromosome positive'}, {'cui': 'C0450407', 'cui_str': 'ph+'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0008625', 'cui_str': 'Abnormalities, Chromosome'}]",63.0,0.0438058,"At low blast levels (1-15%), high-risk ACA showed an increased hazard to die compared to no ACA (ratios: 3.65 in blood; 6.12 in marrow) in contrast to low-risk ACA.","[{'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Hehlmann', 'Affiliation': 'ELN Foundation, Weinheim, Germany. hehlmann.eln@gmail.com.'}, {'ForeName': 'Astghik', 'Initials': 'A', 'LastName': 'Voskanyan', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lauseker', 'Affiliation': 'IBE Universität München, München, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Pfirrmann', 'Affiliation': 'IBE Universität München, München, Germany.'}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Kalmanti', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Rinaldetti', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kohlbrenner', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Haferlach', 'Affiliation': 'MLL, München, Germany.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Schlegelberger', 'Affiliation': 'Institut für Humangenetik, MHH, Hannover, Germany.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Fabarius', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Seifarth', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Spieß', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Wuchter', 'Affiliation': 'Institut für Transfusionsmedizin und Immunologie, Medizinische Fakultät Mannheim, Universität Heidelberg und DRK-Blutspendedienst, Mannheim, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Krause', 'Affiliation': 'Medizinische Klinik 5, Universitätsklinikum, Erlangen, Germany.'}, {'ForeName': 'Hans-Jochem', 'Initials': 'HJ', 'LastName': 'Kolb', 'Affiliation': 'Medizinische Klinik III, Universitätsklinikum Großhadern, München, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Neubauer', 'Affiliation': 'Klinik für Innere Medizin, Universitätsklinikum, Marburg, Germany.'}, {'ForeName': 'Dieter K', 'Initials': 'DK', 'LastName': 'Hossfeld', 'Affiliation': '2. Medizinische Klinik, Universitätsklinikum Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Nerl', 'Affiliation': 'Klinikum Schwabing, München, Germany.'}, {'ForeName': 'Alois', 'Initials': 'A', 'LastName': 'Gratwohl', 'Affiliation': 'Universitätsspital, Basel, Switzerland.'}, {'ForeName': 'Gabriela M', 'Initials': 'GM', 'LastName': 'Baerlocher', 'Affiliation': 'Inselspital, Bern, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Burchert', 'Affiliation': 'Klinik für Innere Medizin, Universitätsklinikum, Marburg, Germany.'}, {'ForeName': 'Tim H', 'Initials': 'TH', 'LastName': 'Brümmendorf', 'Affiliation': 'Uniklinik RWTH, Aachen, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Hasford', 'Affiliation': 'IBE Universität München, München, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hochhaus', 'Affiliation': 'Klinik für Innere Medizin II, Universitätsklinikum, Jena, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Saußele', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Baccarani', 'Affiliation': 'Department of Hematology-Oncology, Policlinico S.Orsola-Malpighi, University of Bologna, Bologna, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Leukemia,['10.1038/s41375-020-0826-9']
47,32363592,"Effects of Alcohol Cue Reactivity on Subsequent Treatment Outcomes Among Treatment-Seeking Individuals with Alcohol Use Disorder: A Multisite Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Varenicline.","BACKGROUND


The alcohol cue reactivity paradigm is increasingly used to screen medications for the treatment of alcohol use disorder (AUD) and other substance use disorders. Yet, its prospective association with craving and naturalistic drinking outcomes in clinical trials remains unknown. This study embedded repeated human laboratory assessments of alcohol cue reactivity within the context of a randomized controlled trial to examine the effects of varenicline tartrate (Chantix ®  ), a partial agonist of α4β2 nicotinic acetylcholine receptors, on alcohol craving among treatment-seeking heavy drinkers with AUD. Our main objectives were to test whether varenicline, as compared to placebo, blunts alcohol cue-elicited craving and test whether alcohol cue reactivity observed in the human laboratory predicts subsequent alcohol craving and use during the remainder of the trial.
DESIGN AND METHODS


This double-blind, randomized, 2-site study compared the effects of varenicline (up to 2 mg/d) and placebo on responses to in vivo alcohol cue and affective picture cue exposure in the human laboratory. Forty-seven volunteers (18 females, 29 males), ages 23 to 67 years (M = 43.7, SD = 11.5), were recruited from the community via advertisements to participate in a clinical trial designed to study the effects of varenicline on alcohol use. Participants were randomized to either varenicline or placebo for 6 weeks.
RESULTS


Varenicline did not attenuate cue-induced alcohol craving relative to placebo, but craving captured during the cue reactivity paradigm significantly predicted subsequent alcohol use in real-world settings during the clinical trial. Higher craving predicted heavier alcohol use.
CONCLUSIONS


Our results are among the first to show alcohol cue-induced craving captured during a human laboratory paradigm predicts drinking outcomes in the context of a clinical trial.",2020,"RESULTS


Varenicline did not attenuate cue-induced alcohol craving relative to placebo, but craving captured during the cue reactivity paradigm significantly predicted subsequent alcohol use in real-world settings during the clinical trial.","['Forty-seven volunteers (18 females, 29 males), ages 23 to 67 years (M = 43.7, SD = 11.5', 'Treatment-Seeking Individuals with Alcohol Use Disorder', 'treatment-seeking heavy drinkers with AUD']","['Placebo', 'Alcohol Cue Reactivity', 'varenicline or placebo', 'Varenicline', 'varenicline', 'varenicline tartrate (Chantix ®  ', 'placebo']","['alcohol craving', 'cue-induced alcohol craving']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C1711887', 'cui_str': 'Varenicline tartrate'}, {'cui': 'C1712042', 'cui_str': 'Chantix'}]","[{'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",47.0,0.0949334,"RESULTS


Varenicline did not attenuate cue-induced alcohol craving relative to placebo, but craving captured during the cue reactivity paradigm significantly predicted subsequent alcohol use in real-world settings during the clinical trial.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Miranda', 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Treloar Padovano', 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Falk', 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Megan L', 'Initials': 'ML', 'LastName': 'Ryan', 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Joanne B', 'Initials': 'JB', 'LastName': 'Fertig', 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Chun', 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Srinivas B', 'Initials': 'SB', 'LastName': 'Muvvala', 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Raye Z', 'Initials': 'RZ', 'LastName': 'Litten', 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14352']
48,32369661,"Double-blind, randomized controlled trial of therapeutic plasma exchanges vs sham exchanges in moderate-to-severe relapses of multiple sclerosis.","INTRODUCTION


No randomized controlled clinical trial of therapeutic plasma exchanges (TPE) has yet been performed for moderate-to-severe relapses of multiple sclerosis (MS).
OBJECTIVE


To compare TPE to sham-TPE in patients with a recent steroid-resistant moderate-to-severe MS relapse.
METHODS


Patients presenting with an MS relapse of less than 2 months without improvement and 15 days after a course of steroids were randomized. Specific criteria were used for each relapse type to define moderate-to-severe disability. The primary endpoint was the proportion of patients with at least a moderate improvement based on objective and functional evaluation after 1 month.
RESULTS


Thirty-eight patients were randomized. The intention-to-treat analysis included 14 patients in the TPE group and 17 in the Sham-TPE group. The proportion of patients with at least moderate improvement at 1 month did not differ between the groups (P = .72), although 57.1% of the TPE group had full recovery compared with 17.6% of the sham group. Considering optic neuritis (ON), a significant difference in the proportion of different levels of improvement was observed in favor of the TPE group (P = .04). The combined Kurtzke's functional systems scores were significantly more improved in the TPE group than in the sham-TPE group at months 1 (P < .01), 3 (P < .05), and 6 (P < .05). No major side effects were observed.
CONCLUSIONS


A significant difference between TPE and Sham-TPE at the primary endpoint was only observed in patients with ON. Neurological function improved significantly more often in the TPE group than in the sham-TPE group.",2020,The combined Kurtzke's functional systems scores were significantly more improved in the TPE group than in the sham-TPE group at months 1,"['14 patients in the TPE group and 17 in the Sham-TPE group', 'Thirty-eight patients were randomized', 'moderate-to-severe relapses of multiple sclerosis', 'Patients presenting with an MS relapse of less than 2 months without improvement and 15\u2009days after a course of steroids were randomized', 'patients with a recent steroid-resistant moderate-to-severe MS relapse']","['TPE to sham-TPE', 'therapeutic plasma exchanges (TPE', 'TPE', 'TPE and Sham-TPE', 'sham-TPE']","['proportion of patients with at least a moderate improvement based on objective and functional evaluation', 'full recovery', 'Neurological function', ""combined Kurtzke's functional systems scores""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032113', 'cui_str': 'Plasma exchange'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]","[{'cui': 'C0032113', 'cui_str': 'Plasma exchange'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",38.0,0.0777967,The combined Kurtzke's functional systems scores were significantly more improved in the TPE group than in the sham-TPE group at months 1,"[{'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Brochet', 'Affiliation': 'CHU de Bordeaux, Service de Neurologie, Bordeaux, France.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Deloire', 'Affiliation': 'CHU de Bordeaux, Service de Neurologie, Bordeaux, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Germain', 'Affiliation': 'USMR, Pole de Sante Publique, CHU de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Ouallet', 'Affiliation': 'CHU de Bordeaux, Service de Neurologie, Bordeaux, France.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wittkop', 'Affiliation': 'USMR, Pole de Sante Publique, CHU de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Dulau', 'Affiliation': 'CHU de Bordeaux, Service de Neurologie, Bordeaux, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Perez', 'Affiliation': 'USMR, Pole de Sante Publique, CHU de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Thevenot', 'Affiliation': ""Etablissement Français du Sang, Site de l'Hôpital Pellegrin, Bordeaux, France.""}, {'ForeName': 'Jérome', 'Initials': 'J', 'LastName': 'De Sèze', 'Affiliation': 'Service de Neurologie, CHU de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Zéphir', 'Affiliation': 'Univ.Lille, Inserm U1172, CHU Lille, FHU Imminent, Lille, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Vermersch', 'Affiliation': 'Univ.Lille, Inserm U1172, CHU Lille, FHU Imminent, Lille, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pittion', 'Affiliation': 'Service de Neurologie, CHU de Nancy, Nancy, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Debouverie', 'Affiliation': 'Service de Neurologie, CHU de Nancy, Nancy, France.'}, {'ForeName': 'David-Axel', 'Initials': 'DA', 'LastName': 'Laplaud', 'Affiliation': 'Service de Neurologie, CHU de Nantes, Nantes, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Clavelou', 'Affiliation': 'Service de Neurologie, CHU de Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Ruet', 'Affiliation': 'CHU de Bordeaux, Service de Neurologie, Bordeaux, France.'}]",Journal of clinical apheresis,['10.1002/jca.21788']
49,32372454,The effect of glucagon-like peptide-1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across baseline blood pressure categories: Analysis of the LEADER and SUSTAIN 6 trials.,"It is unknown if the cardioprotective and renal effects of glucagon-like peptide-1 receptor agonists are consistent across blood pressure (BP) categories in patients with type 2 diabetes and at high risk of cardiovascular events. Using data from the LEADER (9340 patients) and SUSTAIN 6 (3297 patients) trials, we evaluated post hoc the cardiorenal effect of liraglutide and semaglutide on major adverse cardiovascular events (MACE) and nephropathy by baseline BP categories using a Cox proportional hazards model (treatment and subgroup as factors; adjusted for cardiorenal risk factors). Data from the two trials were analysed separately. In the LEADER and SUSTAIN 6 trials, the prevalence of stage 1 hypertension was 30% and 31%, respectively, and of stage 2 hypertension 41% and 43%, respectively. There was no statistical heterogeneity across the BP categories for the effects of liraglutide (P = .06 for MACE; P = .14 for nephropathy) or semaglutide (P = .40 for MACE; P = .27 for nephropathy) versus placebo. This implies that liraglutide and semaglutide may be beneficial for patients with type 2 diabetes, irrespective of their baseline BP.",2020,There was no statistical heterogeneity across the BP categories for the effects of liraglutide (p = 0.06 for MACE; p = 0.14 for nephropathy) or semaglutide (p = 0.40 for MACE; p = 0.27 for nephropathy) versus placebo.,"['9340 patients) and SUSTAIN 6 (3297 patients) trials', 'patients with type 2 diabetes and at high risk of cardiovascular events', 'patients with type 2 diabetes']","['LEADER', 'liraglutide', 'glucagon-like peptide-1 receptor agonists liraglutide and semaglutide', 'liraglutide and semaglutide', 'placebo']","['prevalence of stage 1 hypertension', 'major adverse cardiovascular events (MACE) and nephropathy by baseline BP categories', 'blood pressure (BP) categories']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",9340.0,0.114719,There was no statistical heterogeneity across the BP categories for the effects of liraglutide (p = 0.06 for MACE; p = 0.14 for nephropathy) or semaglutide (p = 0.40 for MACE; p = 0.27 for nephropathy) versus placebo.,"[{'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital and University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Bain', 'Affiliation': 'Institute of Life Science, Swansea University, Swansea, UK.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center & Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Mazer', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital and University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Hospital Translational Research Institute, Orlando, Florida, USA.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Maria Sejersten', 'Initials': 'MS', 'LastName': 'Ripa', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Hrvoje', 'Initials': 'H', 'LastName': 'Vrazic', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital and University of Toronto, Toronto, Ontario, Canada.""}]","Diabetes, obesity & metabolism",['10.1111/dom.14079']
50,32381495,Video-observed therapy and medication adherence for tuberculosis patients: randomised controlled trial in Moldova.,"INTRODUCTION


The effectiveness of video-observed therapy (VOT) for treating tuberculosis (TB) has not been measured in low- and middle-income countries (LMICs), where >95% of TB cases and deaths occur. In this study, we analyse the effectiveness and patient cost-difference of VOT compared to clinic-based directly observed therapy (DOT) in improving medication adherence in Moldova, a LMIC in Eastern Europe.
METHODS


The study was a two-arm individually randomised trial with 197 TB patients (n=99 DOT control group; n=98 VOT treatment group; multidrug-resistant TB cases were excluded). The primary outcome was observed medication adherence, measured by the number of days that a patient failed to be observed adhering to medication for every 2-week period during the course of their treatment.
RESULTS


VOT significantly decreased nonadherence by 4 days (95% CI 3.35-4.67 days, p<0.01) per 2-week period: 5.24 days missed per 2-week period for DOT and 1.29 days for VOT. VOT patients spent MDL 504 (∼EUR 25) (95% CI MDL 277-730, p<0.01) and 58 h (95% CI 48-68 h, p<0.01) less on their treatment. In addition, VOT increased self-reported satisfaction with treatment. We found no significant results pertaining to treatment success, patient wellbeing or patient employment status and some evidence of an increase in side-effects.
DISCUSSION


In this trial, VOT increased observed medication adherence for TB patients in Moldova, a LMIC, when compared to clinic-based DOT. Additionally, VOT significantly reduced the time and money patients spent on their treatment.",2020,"We found no significant results pertaining to treatment success, patient well-being or patient employment status and some evidence of an increase in side effects.
","['Moldova, a LMIC in Eastern Europe', '197 TB patients (n=99 in DOT control group; 98 in VOT treatment group, MDR-TB cases were excluded', 'TB patients: RCT in Moldova']","['Video observed therapy (VOT', 'Video Observed Therapy (VOT', 'clinic-based Directly Observed Therapy (DOT', 'VOT']","['medication adherence', 'number of days that a patient failed to be observed adhering to medication', 'VOT', 'VOT patients spent 504 Moldovan Leu (MDL', 'side effects']","[{'cui': 'C0026374', 'cui_str': 'Moldavia'}, {'cui': 'C0015177', 'cui_str': 'East European country'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0206526', 'cui_str': 'Multidrug resistant tuberculosis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0872145', 'cui_str': 'Directly Observed Therapy'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0035827', 'cui_str': 'Rumanian language'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",197.0,0.085522,"We found no significant results pertaining to treatment success, patient well-being or patient employment status and some evidence of an increase in side effects.
","[{'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Ravenscroft', 'Affiliation': 'Behavioural Insights Team, London, UK luke.ravenscroft@bi.team.'}, {'ForeName': 'Stewart', 'Initials': 'S', 'LastName': 'Kettle', 'Affiliation': 'Behavioural Insights Team, London, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Persian', 'Affiliation': 'Behavioural Insights Team, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Ruda', 'Affiliation': 'Behavioural Insights Team, London, UK.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Severin', 'Affiliation': 'Act For Involvement, Chișinău, Moldova.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Doltu', 'Affiliation': 'Act For Involvement, Chișinău, Moldova.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Schenck', 'Affiliation': 'Carnegie Mellon University, Pittsburgh, PA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Loewenstein', 'Affiliation': 'Carnegie Mellon University, Pittsburgh, PA, USA.'}]",The European respiratory journal,['10.1183/13993003.00493-2020']
51,32381556,Effect of a Digital Health Intervention on Decreasing Barriers and Increasing Facilitators for Colorectal Cancer Screening in Vulnerable Patients.,"BACKGROUND


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


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


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


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


Understanding the factors that mediated mPATH-CRC's success is paramount to developing other effective interventions.",2020,"Perceived benefits, self-efficacy, ability to state a screening decision, and patient/provider discussion were statistically significant mediators.","['Colorectal cancer (CRC', 'Participants were enrolled from 6 community-based primary care practices between June 2014 and May 2016 and randomized to either', '408 patients had complete data for all potential mediators', 'Colorectal Cancer Screening in Vulnerable Patients', 'iPad patient decision aid called Mobile Patient Technology for Health-CRC (mPATH-CRC) doubled the proportion of patients who completed CRC screening']","['usual care or mPATH-CRC', 'Digital Health Intervention']","['Perceived benefits, self-efficacy, ability to state a screening decision, and patient/provider discussion', 'completion of CRC screening']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]",408.0,0.0654856,"Perceived benefits, self-efficacy, ability to state a screening decision, and patient/provider discussion were statistically significant mediators.","[{'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Denizard-Thompson', 'Affiliation': 'Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina. ndenizar@wakehealth.edu.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Miller', 'Affiliation': 'Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Snavely', 'Affiliation': 'Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Spangler', 'Affiliation': 'Department of Family and Community Medicine, Wake Forest School of Medicine, Winston Salem, North Carolina.'}, {'ForeName': 'L Doug', 'Initials': 'LD', 'LastName': 'Case', 'Affiliation': 'Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Weaver', 'Affiliation': 'Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-19-1199']
52,32323890,Higher plasma asparaginase activity after intramuscular than intravenous Erwinia asparaginase.,"It is unclear if dosing intervals for Erwinase can be extended with intramuscular (i.m.) versus intravenous (i.v.) dosing. Children with acute lymphoblastic leukemia received Erwinase at 30 000-42 000 IU/m 2  i.v. or i.m. I.m. Erwinase (n = 22) achieved activity above 0.1 IU/mL for longer than i.v. Erwinase (n = 33) (3.4 vs 2.9 days, P = 0.0007). With 30 000 IU/m 2  Monday, Wednesday, Friday, more patients achieved adequate concentrations over the weekend with i.m. vs i.v. dosing (P = 5 × 10 -36  ). A schedule with i.v. doses on Monday and Wednesday and i.m. doses on Friday of 30 000 IU/m 2  maintained activity > 0.1 IU/mL over the weekend in 80% of patients.",2020,Erwinase (n = 22) achieved activity above 0.1 IU/mL for longer than i.v.,"['Children with acute lymphoblastic leukemia', 'Erwinase (n\xa0=\xa033) ']",[],"['activity', 'Higher plasma asparaginase activity', 'adequate concentrations']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0591457', 'cui_str': 'Erwinase'}]",[],"[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0241334,Erwinase (n = 22) achieved activity above 0.1 IU/mL for longer than i.v.,"[{'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Panetta', 'Affiliation': ""Department of Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Yiwei', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Hope D', 'Initials': 'HD', 'LastName': 'Swanson', 'Affiliation': ""Department of Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Seth E', 'Initials': 'SE', 'LastName': 'Karol', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Ching-Hon', 'Initials': 'CH', 'LastName': 'Pui', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Inaba', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Jeha', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Mary V', 'Initials': 'MV', 'LastName': 'Relling', 'Affiliation': ""Department of Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, Tennessee.""}]",Pediatric blood & cancer,['10.1002/pbc.28244']
53,32385867,Effect of gauze placement soaked with adrenaline at suprabullar recess on hemostasis during endoscopic sinus surgery: A randomized controlled trial.,"BACKGROUND


Topical application of vasoconstrictors is necessary for endoscopic sinus surgery (ESS) for a bloodless surgical view and reduced intraoperative bleeding. We aimed to verify the effectiveness of gauze placement soaked with adrenaline at suprabullar recess, where the anterior ethmoidal artery exists, on hemostasis during ESS.
METHODS


A randomized, double-blinded trial was carried out for 26 patients receiving ESS. At the beginning of the surgery, gauze soaked with 2% lidocaine with or without 1:10 000 adrenaline was placed at the suprabullar recess for 8 minutes. Estimated blood loss, surgical field score, and operation time were compared between the two groups.
RESULTS


Estimated blood loss and surgical field score were significantly smaller in the adrenaline group than in the no adrenaline group. Operation time was not significantly different between the two groups.
CONCLUSION


Gauze placement soaked with adrenaline at suprabullar recess reduces estimated blood loss and clears the surgical field during ESS.",2020,"RESULTS


Estimated blood loss and surgical field score were significantly smaller in the adrenaline group than in the no adrenaline group.","['26 patients receiving ESS', 'hemostasis during endoscopic sinus surgery']","['gauze soaked with 2% lidocaine', 'Gauze placement soaked with adrenaline', 'gauze placement soaked with adrenaline', 'adrenaline']","['Operation time', 'blood loss and surgical field score', 'Estimated blood loss, surgical field score, and operation time', 'blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}]","[{'cui': 'C0590323', 'cui_str': 'Gauzes'}, {'cui': 'C0204774', 'cui_str': 'Soak'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}]",26.0,0.124124,"RESULTS


Estimated blood loss and surgical field score were significantly smaller in the adrenaline group than in the no adrenaline group.","[{'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Omura', 'Affiliation': 'Department of Otolaryngology, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hosokawa', 'Affiliation': 'Department of Otolaryngology, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Nomura', 'Affiliation': 'Department of Otolaryngology, Tohoku Kosai Hospital, Sendai-shi, Miyagi, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Aoki', 'Affiliation': 'Department of Otolaryngology, Dokkyo Medical University Saitama Medical Center, Koshigaya-shi, Saitama, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Tochigi', 'Affiliation': 'Department of Otolaryngology, Dokkyo Medical University Saitama Medical Center, Koshigaya-shi, Saitama, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Miyashita', 'Affiliation': 'Department of Otolaryngology, Dokkyo Medical University Saitama Medical Center, Koshigaya-shi, Saitama, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Department of Otolaryngology, Dokkyo Medical University Saitama Medical Center, Koshigaya-shi, Saitama, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Otori', 'Affiliation': 'Department of Otolaryngology, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Kojima', 'Affiliation': 'Department of Otolaryngology, The Jikei University School of Medicine, Tokyo, Japan.'}]",Head & neck,['10.1002/hed.26243']
54,32385918,Randomized Phase II Study of First-Line Biweekly Gemcitabine and Carboplatin Versus Biweekly Gemcitabine and Carboplatin plus Maintenance Gemcitabine in Elderly Patients with Untreated Non-Small Cell Lung Cancer: LOGIK0801.,"LESSONS LEARNED


The usefulness of maintenance gemcitabine (GEM) after biweekly carboplatin + GEM in elderly patients with non-small cell lung cancer could not be proved. Superior overall survival was obtained in the group that did not receive maintenance therapy.
BACKGROUND


The primary objective of this randomized phase II study was to assess progression-free survival (PFS) in elderly patients with advanced non-small cell lung cancer (NSCLC) treated with gemcitabine (GEM) maintenance therapy versus best supportive care following first-line GEM plus carboplatin (CBDCA).
METHODS


Elderly chemotherapy-naive patients with stage IIIB or IV NSCLC were randomly assigned 1:1 to the control arm or the study arm. All patients received biweekly combination therapy with GEM and CBDCA (1,000 mg/m 2  GEM and CBDCA at an area under the curve [AUC] of 3 on days 1 and 15, every 4 weeks). In the study arm, patients with objective response or stable disease following three or four cycles of initial chemotherapy received maintenance GEM.
RESULTS


Eighty-four patients were enrolled. The objective response rates (ORRs) were 17.5% in the control arm and 14.0% in the study arm. The most common toxicity was neutropenia (control arm: 47.5% and study arm: 69.8%). The median progression-free survivals were 4.99 months (control arm) and 4.44 months (study arm), and the median overall survivals (OSs) were 21.7 months (control arm) and 8.2 months (study arm).
CONCLUSION


Our data do not support maintenance GEM after biweekly CBDCA+GEM in elderly patients with NSCLC.",2020,The most common toxicity was neutropenia,"['elderly patients with non-small cell lung cancer', 'Elderly chemotherapy-naive patients with stage IIIB or IV NSCLC', 'elderly patients with advanced non-small cell lung cancer', 'Elderly Patients with Untreated Non-Small Cell Lung Cancer', 'elderly patients with NSCLC', 'Eighty-four patients were enrolled']","['Gemcitabine and Carboplatin Versus Biweekly Gemcitabine and Carboplatin plus Maintenance Gemcitabine', 'gemcitabine (GEM) maintenance therapy', 'GEM plus carboplatin (CBDCA', 'maintenance gemcitabine (GEM', 'biweekly combination therapy with GEM and CBDCA', 'carboplatin + GEM']","['neutropenia', 'Superior overall survival', 'median overall survivals (OSs', 'progression-free survival (PFS', 'objective response rates (ORRs', 'median progression-free survivals']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C4319623', 'cui_str': '84'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",84.0,0.0509466,The most common toxicity was neutropenia,"[{'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Takayama', 'Affiliation': 'Department of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Takeshita', 'Affiliation': 'Department of Respiratory Medicine, Kitakyushu Municipal Medical Center, Kitakyushu, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Inoue', 'Affiliation': 'Department of Respiratory Medicine, Kitakyushu Municipal Medical Center, Kitakyushu, Japan.'}, {'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Ichiki', 'Affiliation': 'Department of Respirology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Fujita', 'Affiliation': 'Department of Respiratory Medicine, Fukuoka University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Taishi', 'Initials': 'T', 'LastName': 'Harada', 'Affiliation': 'Department of Respiratory Medicine, Japan Community Healthcare Organization Kyushu Hospital, Kitakyushu, Japan.'}, {'ForeName': 'Yoshimasa', 'Initials': 'Y', 'LastName': 'Shiraishi', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Wataya', 'Affiliation': 'Division of Internal Medicine, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.'}, {'ForeName': 'Shoji', 'Initials': 'S', 'LastName': 'Tokunaga', 'Affiliation': 'Medical Information Center, Kyushu University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Tadaaki', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Uchino', 'Affiliation': 'Department of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Sugio', 'Affiliation': 'Department of Thoracic and Breast Surgery, Oita University, Faculty of Medicine, Oita, Japan.'}]",The oncologist,['10.1634/theoncologist.2020-0322']
55,32374442,Comparing case-based and lecture-based learning strategies for orthodontic case diagnosis: A randomized controlled trial.,"BACKGROUND


Case-based learning (CBL), in contrast to traditional lecture-based learning (LBL), is an andragogical method carrying an earnest teaching approach that uses demonstration of clinical cases as an active learning tool.
OBJECTIVE


To compare the effectiveness of knowledge delivery and student satisfaction between CBL and LBL strategies to diagnose orthodontic cases.
METHODS


A single-blinded randomized controlled trial was performed. The sample of dental undergraduate students was randomly divided into 2 groups. Average GPA among the groups was compared to establish the baseline measure. Visual slides of 6 orthodontic diagnostic cases were presented to the students after implementing the teaching strategies, and a rubrics-based assessment method was adopted to assess the effectiveness in diagnosis. A questionnaire was distributed to compare the level of satisfaction between the groups exposed to CBL and LBL. A t-test was performed to assess the difference in effectiveness, while Cochran-Armitage trend analysis was performed to analyze the difference in the level of satisfaction between LBL and CBL experiences.
RESULTS


We detected no significant (P = 0.11) relation of gender with effective orthodontic diagnosis. The orthodontic diagnostic ability of students for the 6 cases was significantly different (P < 0.05) in the CBL and LBL groups. The satisfaction score obtained for the CBL group was higher than for the LBL group (P < 0.05).
CONCLUSION


The current study provides evidence that CBL is an effective and acceptable teaching strategy in comparison to traditional LBL among undergraduate dental students embarking on an orthodontic diagnostic course.",2020,"The satisfaction score obtained for the CBL group was higher than for the LBL group (P < 0.05).
","['6 orthodontic diagnostic cases', 'sample of dental undergraduate students', 'orthodontic case diagnosis']","['Case-based learning (CBL', 'LBL', 'CBL', 'traditional lecture-based learning (LBL', 'lecture-based learning strategies']","['level of satisfaction', 'satisfaction score', 'orthodontic diagnostic ability', 'Visual slides']","[{'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0332246', 'cui_str': 'Sliding'}]",,0.0415369,"The satisfaction score obtained for the CBL group was higher than for the LBL group (P < 0.05).
","[{'ForeName': 'Anwar', 'Initials': 'A', 'LastName': 'Alhazmi', 'Affiliation': 'Division of Orthodontics, Department of Preventive Dental Sciences, College of Dentistry, Jazan University, Jazan, Saudi Arabia.'}, {'ForeName': 'Mir Faeq Ali', 'Initials': 'MFA', 'LastName': 'Quadri', 'Affiliation': 'Evidence Based Dentistry, Department of Preventive Dental Sciences, College of Dentistry, Jazan University, Jazan, Saudi Arabia.'}]",Journal of dental education,['10.1002/jdd.12171']
56,32385506,"Cardiovascular outcomes, bleeding risk, and achieved blood pressure in patients on long-term anticoagulation with the thrombin antagonist dabigatran or warfarin: data from the RE-LY trial.","AIMS


A J-shaped association of cardiovascular events to achieved systolic (SBP) and diastolic (DBP) blood pressure was shown in high-risk patients. This association on oral anticoagulation is unknown. This analysis from RELY assessed the risks of death, stroke or systemic emboli, and bleeding according to mean achieved SBP and DBP in atrial fibrillation on oral anticoagulation.
METHODS AND RESULTS


RE-LY patients were followed for 2 years and recruited between 22 December 2005 until 15 December 2007. 18.113 patients were randomized in 951 centres in 54 countries and 18,107 patients with complete blood pressure (BP) data were analysed with a median follow-up of 2.0 years and a complete follow-up in 99.9%. The association between achieved mean SBP and DBP on all-cause death, stroke and systemic embolic events (SSE), major, and any bleeding were explored. On treatment, SBP >140 mmHg and <120 mmHg was associated with all-cause death compared with SBP 120-130 mmHg (reference). For SSE, risk was unchanged at SBP <110 mmHg but increased at 140-160 mmHg (adjusted hazard ratio (HR) 1.81; 1.40-2.33) and SBP ≥160 mmHg (HR 3.35; 2.09-5.36). Major bleeding events were also increased at <110 mmHg and at 110 to <120 mmHg. Interestingly, there was no increased risk of major bleeding at SBP >130 mmHg. Similar patterns were observed for DBP with an increased risk at <70 mmHg (HR 1.55; 1.35-1.78) and >90 mmHg (HR 1.88; 1.43-2.46) for all-cause death compared to 70 to <80 mmHg (reference). Risk for any bleeding was increased at low DBP <70 mmHg (HR 1.46; 1.37-1.56) at DBP 80 to <90 mmHg (HR 1.13; 1.06-1.31) without increased risk at higher achieved DBP. Dabigatran 150 mg twice daily showed an advantage in all patients for all-cause death and SSE and there was an advantage for 110 mg dabigatran twice daily for major bleeding and any bleeding irrespective of SBP or DBP achieved. Similar results were obtained for baseline BP, time-updated BP, and BP as time-varying covariate.
CONCLUSION


Low achieved SBP associates with increased risk of death, SSE, and bleeding in patients with atrial fibrillation on oral anticoagulation. Major bleeding events did not occur at higher BP. Low BP might identify high-risk patients not only for death but also for high bleeding risks.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov-Identifier: NCT00262600.",2020,Dabigatran 150 mg twice daily showed an advantage in all patients for all-cause death and SSE and there was an advantage for 110 mg dabigatran twice daily for major bleeding and any bleeding irrespective of SBP or DBP achieved.,"['18.113 patients were randomized in 951 centres in 54 countries and 18,107 patients with complete blood pressure (BP) data were analysed with a median follow-up of 2.0\u2009years and a complete follow-up in 99.9', 'high-risk patients', 'patients with atrial fibrillation on oral anticoagulation', 'RE-LY patients were followed for 2\u2009years and recruited between 22 December 2005 until 15 December 2007']","['thrombin antagonist dabigatran or warfarin', 'Dabigatran']","['risk of death, SSE, and bleeding', 'risks of death, stroke or systemic emboli, and bleeding', 'risk of major bleeding', 'baseline BP, time-updated BP, and BP as time-varying covariate', 'Risk for any bleeding', 'Major bleeding events', 'systolic (SBP) and diastolic (DBP) blood pressure', 'mean SBP and DBP on all-cause death, stroke and systemic embolic events (SSE), major, and any bleeding', 'Cardiovascular outcomes, bleeding risk, and achieved blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517914', 'cui_str': '99.9'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1704212', 'cui_str': 'Embolus'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",18107.0,0.0248259,Dabigatran 150 mg twice daily showed an advantage in all patients for all-cause death and SSE and there was an advantage for 110 mg dabigatran twice daily for major bleeding and any bleeding irrespective of SBP or DBP achieved.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Klinik für Innere Medizin III, Saarland University Medical Center, Kirrberger Str. 1, 66421 Homburg, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Medicine CardioMetabolism & Respiratory, Boehringer Ingelheim International GmbH, Binger Strasse 173, 55216 Ingelheim am Rhein, Germany.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Eikelboom', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton Health Sciences - King West, PO Box 2000, Hamilton, Ontario L8N 3Z5, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ezekowitz', 'Affiliation': 'Sidney Kimmel Medical College at Jefferson University, 1025 Walnut Street, Philadelphia, PA 19107, USA.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Fräßdorf', 'Affiliation': 'CardioMetabolism & Respiratory Medicine, Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Straße 173, 55216 Ingelheim am Rhein, Germany.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Hijazi', 'Affiliation': 'Department of Medical Sciences, UCR Uppsala Clinical Research Center, Uppsala Science Park, Hubben, Dag Hammarskjölds väg 38, SE-751 85 Uppsala, Sweden.'}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Department of Cardiology, Goethe-Universität Frankfurt am Main, 60629 Frankfurt/Main, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Mahfoud', 'Affiliation': 'Klinik für Innere Medizin III, Saarland University Medical Center, Kirrberger Str. 1, 66421 Homburg, Germany.'}, {'ForeName': 'Roland E', 'Initials': 'RE', 'LastName': 'Schmieder', 'Affiliation': 'Department of Nephrology and Hypertension, University Hospital Erlangen, Friedrich-Alexander University, Schloßplatz 4, 91054 Erlangen, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Schumacher', 'Affiliation': 'Statistical Consultant, 55216 Ingelheim, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Wallentin', 'Affiliation': 'Department of Medical Sciences, UCR Uppsala Clinical Research Center, Uppsala Science Park, Hubben, Dag Hammarskjölds väg 38, SE-751 85 Uppsala, Sweden.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton Health Sciences - King West, PO Box 2000, Hamilton, Ontario L8N 3Z5, Canada.'}]",European heart journal,['10.1093/eurheartj/ehaa247']
57,31810064,High-Intensity Interval Versus Moderate-Intensity Continuous Training in Individuals With Parkinson's Disease: Hemodynamic and Functional Adaptation.,"PURPOSE


To investigate the effect of high-intensity interval training (HIIT) versus moderate-intensity continuous exercise training (MICE) on hemodynamic and functional variables in individuals with Parkinson's disease.
METHODS


Twenty participants (13 men) were randomly assigned to a thrice-weekly HIIT (n = 12) or MICE (n = 8) for 12 weeks. Hemodynamic (resting heart rate and blood pressure, carotid femoral pulse wave velocity, endothelial reactivity, and heart rate variability) and functional variables (5-time sit-to-stand, timed up and go, and 6-min walking tests) assessed before and after training.
RESULTS


Demographic, hemodynamic and functional variables were similar between groups at baseline. Endothelial reactivity tended to increase after HIIT, but not after MICE, resulting in improved level (∼8%, P < .01) of this variable in HIIT versus MICE during follow-up. Six-minute walking test improved after HIIT (10.4 ± 3.8%, P < .05), but did not change after MICE. Sit to stand improved similarly after HIIT (27.2 ± 6.1%, P < .05) and MICE (21.5 ± 5.4%, P < .05). No significant changes were found after HIIT or MICE in any other variable assessed.
CONCLUSION


These results suggest that exercise intensity may influence training-induced adaptation on endothelial reactivity and aerobic capacity in individuals with Parkinson's disease.",2020,"Sit to stand improved similarly after HIIT (27.2 ± 6.1%, P < .05) and MICE (21.5 ± 5.4%, P < .05).","['Twenty participants (13 men', ""individuals with Parkinson's disease"", ""Individuals With Parkinson's Disease""]","['Moderate-Intensity Continuous Training', 'high-intensity interval training (HIIT) versus moderate-intensity continuous exercise training (MICE', 'MICE']","['Endothelial reactivity', 'Hemodynamic (resting heart rate and blood pressure, carotid femoral pulse wave velocity, endothelial reactivity, and heart rate variability) and functional variables (5-time sit-to-stand, timed up and go, and 6-min walking tests', 'hemodynamic and functional variables', 'endothelial reactivity and aerobic capacity', 'Hemodynamic and Functional Adaptation', 'High-Intensity Interval']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",20.0,0.0402688,"Sit to stand improved similarly after HIIT (27.2 ± 6.1%, P < .05) and MICE (21.5 ± 5.4%, P < .05).","[{'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Fernandes', 'Affiliation': ''}, {'ForeName': 'Fabio Augusto', 'Initials': 'FA', 'LastName': 'Barbieri', 'Affiliation': ''}, {'ForeName': 'Fernanda Zane', 'Initials': 'FZ', 'LastName': 'Arthuso', 'Affiliation': ''}, {'ForeName': 'Fabiana Araújo', 'Initials': 'FA', 'LastName': 'Silva', 'Affiliation': ''}, {'ForeName': 'Gabriel Felipe', 'Initials': 'GF', 'LastName': 'Moretto', 'Affiliation': ''}, {'ForeName': 'Luis Felipe Itikawa', 'Initials': 'LFI', 'LastName': 'Imaizumi', 'Affiliation': ''}, {'ForeName': 'Awassi Yophiwa', 'Initials': 'AY', 'LastName': 'Ngomane', 'Affiliation': ''}, {'ForeName': 'Guilherme Veiga', 'Initials': 'GV', 'LastName': 'Guimarães', 'Affiliation': ''}, {'ForeName': 'Emmanuel Gomes', 'Initials': 'EG', 'LastName': 'Ciolac', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0588']
58,32372651,"The effectiveness of Kinesio Taping ®  for mobility and functioning improvement in knee osteoarthritis: a randomized, double-blind, controlled trial.","OBJECTIVE


To evaluate the effectiveness of the Kinesio Taping ®  method for mobility and functioning improvement for patients with knee osteoarthritis (KO).
DESIGN


Randomized, double-blinded, controlled trial.
SETTING


Outpatient rehabilitation department.
SUBJECTS


A total of 187 subjects with symptomatic I-III grade KO participated; of these, 157 subjects were included in the analyses (intervention group,  n  = 81 (123 knees); control group,  n  = 76 (114 knees).
INTERVENTION


The intervention group received a specific Kinesio Taping application, and the control group received non-specific knee taping for a month.
MAIN MEASURES


Changes in Knee injury and Osteoarthritis Outcome Scores (KOOS), knee active range of motion, 10-Meter Walk, and the five times sit to stand tests (5xSST) were assessed at baseline, after four weeks of taping, and a month post taping intervention. Subjective participants' experiences and opinions on the effect of knee taping were evaluated. The chosen level of significance was  p  < 0.05.
RESULTS


The mean age of participants was 68.7 ± 9.9 in intervention group and 70.6 ± 8.3 in control group ( p  > 0.05). The change from baseline in gait speed in the intervention group after taping month was +0.04 ± 0.1 m/s, at follow-up +0.06 ± 0.1 m/s; in control group +0.07 ± 0.1 m/s, and +0.09 ± 0.1 m/s; the change in time needed to accomplish 5xSST was -2.2 ± 3.2 seconds, at follow-up -2.4 ± 3.1 seconds; in control group -2.8 ± 3.6 seconds, and -2.4 ± 4 seconds. Improved knee flexion and enhancement in functioning assessed by KOOS were noticed in both groups, with lasting improvement to follow up. No difference in the change in the above-mentioned outcomes was found between groups ( p  > 0.05). Fewer subjects (6.2% (5) vs. 21.1% (16),  χ 2  = 7.5,  df  = 2,  p  = 0.024) from Kinesio Taping group were unsure if taping alleviated their mobility and more intervention group patients indicated higher subjective satisfaction with the effect of knee taping to symptom and mobility alleviation than control group ( p  < 0.005).
CONCLUSION


Investigated Kinesio Taping technique did not produce better results in mobility and functioning improvement over non-specific knee taping; however, it had higher patient-reported subjective value for symptom attenuation and experienced mobility enhancement.",2020,"Investigated Kinesio Taping technique did not produce better results in mobility and functioning improvement over non-specific knee taping; however, it had higher patient-reported subjective value for symptom attenuation and experienced mobility enhancement.","['knee osteoarthritis', 'Outpatient rehabilitation department', '187 subjects with symptomatic I-III grade KO participated; of these, 157 subjects were included in the analyses (intervention group,  n \u2009=\u200981 (123 knees); control group,  n\u2009 =\u200976 (114 knees', 'patients with knee osteoarthritis (KO']","['Kinesio Taping technique', 'Kinesio Taping ®', 'specific Kinesio Taping application, and the control group received non-specific knee taping for a month', 'Kinesio Taping ®  method']","['Knee injury and Osteoarthritis Outcome Scores (KOOS), knee active range of motion, 10-Meter Walk, and the five times sit to stand tests (5xSST', 'gait speed', 'subjective satisfaction', 'mobility and functioning improvement', 'knee flexion and enhancement in functioning assessed by KOOS', 'knee taping to symptom and mobility alleviation']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0587478', 'cui_str': 'Rehabilitation department'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",187.0,0.0909194,"Investigated Kinesio Taping technique did not produce better results in mobility and functioning improvement over non-specific knee taping; however, it had higher patient-reported subjective value for symptom attenuation and experienced mobility enhancement.","[{'ForeName': 'Venta', 'Initials': 'V', 'LastName': 'Donec', 'Affiliation': 'Department of Rehabilitation, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Raimondas', 'Initials': 'R', 'LastName': 'Kubilius', 'Affiliation': 'Department of Rehabilitation, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}]",Clinical rehabilitation,['10.1177/0269215520916859']
59,32372750,Assessment of the Feasibility and Acceptability of Using Water Pasteurization Indicators to Increase Access to Safe Drinking Water in the Peruvian Amazon.,"Approximately two billion people lack access to microbiologically safe drinking water globally. Boiling is the most popular household water treatment method and significantly reduces diarrheal disease, but is often practiced inconsistently or ineffectively. The use of low-cost technologies to improve boiling is one approach with potential for increasing access to safe drinking water. We conducted household trials to evaluate the feasibility and acceptability of water pasteurization indicators (WAPIs) in the Peruvian Amazon in 2015. A total of 28 randomly selected households were enrolled from a rural and a peri-urban community. All households trialed two WAPI designs, each for a 2-week period. Ninety-six percent of participants demonstrated the correct use of the WAPIs at the end of each trial, and 88% expressed satisfaction with both WAPI models. Ease of use, short treatment time, knowledge of the association between WAPI use and improved health, and the taste of treated water were among the key factors that influenced acceptability. Ease of use was the key factor that influenced design preference. Participants in both communities preferred a WAPI with a plastic box that floated on the water's surface compared with a WAPI with a wire that was dipped into the pot of drinking water while it was heating (77% versus 15%,  P  < 0.001); we selected the box design for a subsequent randomized trial of this intervention. The high feasibility and acceptability of the WAPIs in this study suggest that these interventions have potential to increase access to safe water in resource-limited settings.",2020,We conducted household trials to evaluate the feasibility and acceptability of water pasteurization indicators (WAPIs) in the Peruvian Amazon in 2015.,"['Peruvian Amazon in 2015', '28 randomly selected households were enrolled from a rural and a peri-urban community']",['water pasteurization indicators (WAPIs'],['diarrheal disease'],"[{'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0597885', 'cui_str': 'Pasteurization'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]","[{'cui': 'C1290807', 'cui_str': 'Diarrheal disorder'}]",28.0,0.026785,We conducted household trials to evaluate the feasibility and acceptability of water pasteurization indicators (WAPIs) in the Peruvian Amazon in 2015.,"[{'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Heitzinger', 'Affiliation': 'Innovacion Por la Salud Y el Desarollo (IPSYD), Asociación Benéfica Prisma, Lima, Peru.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Hawes', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Claudio A', 'Initials': 'CA', 'LastName': 'Rocha', 'Affiliation': 'U.S. Naval Medical Research Unit No. 6, Lima, Peru.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Alvarez', 'Affiliation': 'Regional Center for Disease Prevention and Control, Loreto Regional Ministry of Health, Iquitos, Peru.'}, {'ForeName': 'Carlton A', 'Initials': 'CA', 'LastName': 'Evans', 'Affiliation': 'IFHAD: Innovation for Health and Development, Laboratory of Research and Development, Universidad Peruana Cayetano Heredia, Lima, Peru.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.18-0963']
60,32371514,Impact of a farmers' market nutrition coupon programme on diet quality and psychosocial well-being among low-income adults: protocol for a randomised controlled trial and a longitudinal qualitative investigation.,"INTRODUCTION


Low-income populations have poorer diet quality and lower psychosocial well-being than their higher-income counterparts. These inequities increase the burden of chronic disease in low-income populations. Farmers' market subsidies may improve diet quality and psychosocial well-being among low-income populations. In Canada, the British Columbia (BC) Farmers' Market Nutrition Coupon Programme (FMNCP) aims to improve dietary patterns and health among low-income participants by providing coupons to purchase healthy foods from farmers' markets. This study will assess the impact of the BC FMNCP on the diet quality and psychosocial well-being of low-income adults and explore mechanisms of programme impacts.
METHODS AND ANALYSIS


In a parallel group randomised controlled trial, low-income adults will be randomised to an FMNCP intervention (n=132) or a no-intervention control group (n=132). The FMNCP group will receive 16 coupon sheets valued at CAD$21/sheet over 10-15 weeks to purchase fruits, vegetables, dairy, meat/poultry/fish, eggs, nuts and herbs at farmers' markets and will be invited to participate in nutrition skill-building activities. Overall diet quality (primary outcome), diet quality subscores, mental well-being, sense of community, food insecurity and malnutrition risk (secondary outcomes) will be assessed at baseline, immediately post-intervention and 16 weeks post-intervention. Dietary intake will be assessed using the Automated Self-Administered 24-hour Dietary Recall. Diet quality will be calculated using the Healthy Eating Index-2015. Repeated measures mixed-effect regression will assess differences in outcomes between groups from baseline to 16 weeks post-intervention. Furthermore, 25-30 participants will partake in semi-structured interviews during and 5 weeks after programme completion to explore participants' experiences with and perceived outcomes from the programme.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the University of Calgary Conjoint Health Research Ethics Board, Rutgers University Ethics and Compliance, and University of Waterloo Office of Research Ethics. Findings will be disseminated through policy briefs, conference presentations and peer-reviewed publications.
TRIAL REGISTRATION NUMBER


NCT03952338.",2020,Farmers' Market Nutrition Coupon Programme (FMNCP) aims to improve dietary patterns and health among low-income participants by providing coupons to purchase healthy foods from farmers' markets.,"['among low-income adults', ""low-income participants by providing coupons to purchase healthy foods from farmers' markets"", 'Farmers']","[""farmers' market nutrition coupon programme"", 'FMNCP', 'Market Nutrition Coupon Programme (FMNCP', 'FMNCP intervention (n=132) or a no-intervention control group', 'BC FMNCP']","['burden of chronic disease', 'Diet quality', 'diet quality and psychosocial well-being', 'Overall diet quality (primary outcome), diet quality subscores, mental well-being, sense of community, food insecurity and malnutrition risk (secondary outcomes']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0221460', 'cui_str': 'Farmer'}, {'cui': 'C1318228', 'cui_str': 'Market'}]","[{'cui': 'C0221460', 'cui_str': 'Farmer'}, {'cui': 'C1318228', 'cui_str': 'Market'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006193', 'cui_str': 'British Columbia'}]","[{'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3494174', 'cui_str': 'Food insecurity'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",30.0,0.199752,Farmers' Market Nutrition Coupon Programme (FMNCP) aims to improve dietary patterns and health among low-income participants by providing coupons to purchase healthy foods from farmers' markets.,"[{'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Aktary', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Caron-Roy', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Tolulope', 'Initials': 'T', 'LastName': 'Sajobi', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Cumming School of Medicine, Calgary, Alberta, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': ""O'Hara"", 'Affiliation': ""British Columbia Association of Farmers' Markets, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Leblanc', 'Affiliation': ""British Columbia Association of Farmers' Markets, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Sharlette', 'Initials': 'S', 'LastName': 'Dunn', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Cumming School of Medicine, Calgary, Alberta, Canada.'}, {'ForeName': 'Gavin R', 'Initials': 'GR', 'LastName': 'McCormack', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Timmins', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Cumming School of Medicine, Calgary, Alberta, Canada.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Ball', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Shauna', 'Initials': 'S', 'LastName': 'Downs', 'Affiliation': 'School of Public Health, Rutgers University, Newark, New Jersey, USA.'}, {'ForeName': 'Leia M', 'Initials': 'LM', 'LastName': 'Minaker', 'Affiliation': 'School of Planning, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Candace Ij', 'Initials': 'CI', 'LastName': 'Nykiforuk', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Godley', 'Affiliation': 'Department of Sociology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Milaney', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Cumming School of Medicine, Calgary, Alberta, Canada.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Lashewicz', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Cumming School of Medicine, Calgary, Alberta, Canada.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Fournier', 'Affiliation': 'School of Nursing, Thompson Rivers University, Kamloops, British Columbia, Canada.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Elliott', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Kim D', 'Initials': 'KD', 'LastName': 'Raine', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Rachel Jl', 'Initials': 'RJ', 'LastName': 'Prowse', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Dana Lee', 'Initials': 'DL', 'LastName': 'Olstad', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada dana.olstad@ucalgary.ca.'}]",BMJ open,['10.1136/bmjopen-2019-035143']
61,32380660,"The Effect of Parenteral or Oral Iron Supplementation on Fatigue, Sleep, Quality of Life and Restless Legs Syndrome in Iron-Deficient Blood Donors: A Secondary Analysis of the IronWoMan RCT.","Background : Besides anemia, iron deficiency may cause more subtle symptoms, including the restless legs syndrome (RLS), the chronic fatigue syndrome (CFS) or sleeping disorders.  Objective : The aim of this pre-planned secondary analysis of the IronWoMan randomized controlled trial (RCT) was to compare the frequency and severity of symptoms associated with iron deficiency before and after (intravenous or oral) iron supplementation in iron deficient blood donors.
METHODS/DESIGN


Prospective, randomized, controlled, single-centre trial. (ClinicalTrials.gov: NCT01787526).
SETTING


Tertiary care center in Graz, Austria.
PARTICIPANTS


176 (138 female and 38 male) whole-blood and platelet apheresis donors aged ≥ 18 and ≤ 65 years with iron deficiency (ferritin ≤ 30ng/mL at the time of blood donation).
INTERVENTIONS


Intravenous iron (1 g ferric carboxymaltose, n = 86) or oral iron supplementation (10 g iron fumarate, 100 capsules, n = 90).
MEASUREMENTS


Clinical symptoms were evaluated by a survey before iron therapy (visit 0, V0) and after 8-12 weeks (visit 1, V1), including questions about symptoms of restless legs syndrome (RLS), chronic fatigue syndrome (CFS), sleeping disorders, quality of life and symptoms like headaches, dyspnoea, dizziness, palpitations, pica and trophic changes in fingernails or hair.
RESULTS


We found a significant improvement in the severity of symptoms for RLS, fatigue and sleep quality ( p  < 0.001). Furthermore, a significant decrease in headaches, dyspnoea, dizziness and palpitations was reported ( p  < 0.05). There was no difference between the type of iron supplementation (intravenous versus oral) and clinical outcome data.
CONCLUSION


Iron supplementation in iron-deficient blood donors may be an effective strategy to improve symptoms related to iron deficiency and the wellbeing of blood donors.",2020,"We found a significant improvement in the severity of symptoms for RLS, fatigue and sleep quality ( p  < 0.001).","['Tertiary care center in Graz, Austria', 'Iron-Deficient Blood Donors', '176 (138 female and 38 male) whole-blood and platelet apheresis donors aged ≥ 18 and ≤ 65 years with iron deficiency (ferritin ≤ 30ng/mL at the time of blood donation']","[' ', 'Intravenous iron (1 g ferric carboxymaltose, n = 86) or oral iron supplementation', 'Parenteral or Oral Iron Supplementation', 'Iron supplementation']","['headaches, dyspnoea, dizziness and palpitations', 'severity of symptoms for RLS, fatigue and sleep quality', 'questions about symptoms of restless legs syndrome (RLS), chronic fatigue syndrome (CFS), sleeping disorders, quality of life and symptoms like headaches, dyspnoea, dizziness, palpitations, pica and trophic changes in fingernails or hair', 'Fatigue, Sleep, Quality of Life and Restless Legs Syndrome']","[{'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0005795', 'cui_str': 'Blood donor'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0032202', 'cui_str': 'Plateletpheresis'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005794', 'cui_str': 'Blood Donation'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0030252', 'cui_str': 'Palpitations'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031873', 'cui_str': 'Pica'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0222001', 'cui_str': 'Fingernails'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",176.0,0.346918,"We found a significant improvement in the severity of symptoms for RLS, fatigue and sleep quality ( p  < 0.001).","[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Macher', 'Affiliation': 'Department of Blood Group Serology and Transfusion Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Herster', 'Affiliation': 'Department of Blood Group Serology and Transfusion Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Holter', 'Affiliation': 'Institute for Medical Informatics, Statistics and Documentation, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Moritz', 'Affiliation': 'Department of Blood Group Serology and Transfusion Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Eva Maria', 'Initials': 'EM', 'LastName': 'Matzhold', 'Affiliation': 'Department of Blood Group Serology and Transfusion Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Stojakovic', 'Affiliation': 'Clinical Institute of Medical and Chemical Laboratory Diagnostics, University Hospital Graz, 8036 Graz, Austria.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Pieber', 'Affiliation': 'Division of Endocrinology and Diabetology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schlenke', 'Affiliation': 'Department of Blood Group Serology and Transfusion Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Drexler', 'Affiliation': 'Department of Blood Group Serology and Transfusion Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Amrein', 'Affiliation': 'Division of Endocrinology and Diabetology, Medical University of Graz, 8036 Graz, Austria.'}]",Nutrients,['10.3390/nu12051313']
62,32384053,A Digital Intervention for Adolescent Depression (MoodHwb): Mixed Methods Feasibility Evaluation.,"BACKGROUND


Treatment and prevention guidelines highlight the key role of health information and evidence-based psychosocial interventions for adolescent depression. Digital health technologies and psychoeducational interventions have been recommended to help engage young people and to provide accurate health information, enhance self-management skills, and promote social support. However, few digital psychoeducational interventions for adolescent depression have been robustly developed and evaluated in line with research guidance.
OBJECTIVE


We aimed to evaluate the feasibility, acceptability, and potential impact of a theory-informed, co-designed digital intervention program, MoodHwb.
METHODS


We used a mixed methods (quantitative and qualitative) approach to evaluate the program and the assessment process. Adolescents with or at elevated risk of depression and their parents and carers were recruited from mental health services, school counselors and nurses, and participants from a previous study. They completed a range of questionnaires before and after the program (related to the feasibility and acceptability of the program and evaluation process, and changes in mood, knowledge, attitudes, and behavior), and their Web usage was monitored. A subsample was also interviewed. A focus group was conducted with professionals from health, education, social, and youth services and charities. Interview and focus group transcripts were analyzed using thematic analysis with NVivo 10 (QSR International Pty Ltd).
RESULTS


A total of 44 young people and 31 parents or carers were recruited, of which 36 (82%) young people and 21 (68%) parents or carers completed follow-up questionnaires. In all, 19 young people and 12 parents or carers were interviewed. Overall, 13 professionals from a range of disciplines participated in the focus group. The key themes from the interviews and groups related to the design features, sections and content, and integration and context of the program in the young person's life. Overall, the participants found the intervention engaging, clear, user-friendly, and comprehensive, and stated that it could be integrated into existing services. Young people found the ""Self help"" section and ""Mood monitor"" particularly helpful. The findings provided initial support for the intervention program theory, for example, depression literacy improved after using the intervention (difference in mean literacy score: 1.7, 95% CI 0.8 to 2.6; P<.001 for young people; 1.3, 95% CI 0.4 to 2.2; P=.006 for parents and carers).
CONCLUSIONS


Findings from this early stage evaluation suggest that MoodHwb and the assessment process were feasible and acceptable, and that the intervention has the potential to be helpful for young people, families and carers as an early intervention program in health, education, social, and youth services and charities. A randomized controlled trial is needed to further evaluate the digital program.",2020,"The findings provided initial support for the intervention program theory, for example, depression literacy improved after using the intervention (difference in mean literacy score: 1.7, 95% CI 0.8 to 2.6; P<.001 for young people; 1.3, 95% CI 0.4 to 2.2; P=.006 for parents or carers).
","['Adolescents with or at elevated risk of depression and their parents and carers were recruited from mental health services, school counselors and nurses, and participants from a previous study', 'Adolescent Depression (MoodHwb', 'adolescent depression', '44 young people and 31 parents or carers were recruited, of which 36 (82%) young people and 21 (68%) parents or carers completed follow-up questionnaires', 'Young people', '19 young people and 12 parents or carers were interviewed']",['Digital Intervention'],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1571885', 'cui_str': 'Professional counselor'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],44.0,0.0418669,"The findings provided initial support for the intervention program theory, for example, depression literacy improved after using the intervention (difference in mean literacy score: 1.7, 95% CI 0.8 to 2.6; P<.001 for young people; 1.3, 95% CI 0.4 to 2.2; P=.006 for parents or carers).
","[{'ForeName': 'Rhys', 'Initials': 'R', 'LastName': 'Bevan Jones', 'Affiliation': 'Division of Psychological Medicine and Clinical Neurosciences, Medical Research Council Centre for Neuropsychiatric Genetics and Genomics, Cardiff University, Cardiff, Wales, United Kingdom.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Thapar', 'Affiliation': 'Division of Psychological Medicine and Clinical Neurosciences, Medical Research Council Centre for Neuropsychiatric Genetics and Genomics, Cardiff University, Cardiff, Wales, United Kingdom.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Rice', 'Affiliation': 'Division of Psychological Medicine and Clinical Neurosciences, Medical Research Council Centre for Neuropsychiatric Genetics and Genomics, Cardiff University, Cardiff, Wales, United Kingdom.'}, {'ForeName': 'Becky', 'Initials': 'B', 'LastName': 'Mars', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, England, United Kingdom.'}, {'ForeName': 'Sharifah Shameem', 'Initials': 'SS', 'LastName': 'Agha', 'Affiliation': 'Division of Psychological Medicine and Clinical Neurosciences, Medical Research Council Centre for Neuropsychiatric Genetics and Genomics, Cardiff University, Cardiff, Wales, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, Scotland, United Kingdom.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Merry', 'Affiliation': 'Faculty of Medical and Health Sciences, School of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Stallard', 'Affiliation': 'Department for Health, University of Bath, Bath, England, United Kingdom.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Thapar', 'Affiliation': 'Division of Psychological Medicine and Clinical Neurosciences, Medical Research Council Centre for Neuropsychiatric Genetics and Genomics, Cardiff University, Cardiff, Wales, United Kingdom.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Jones', 'Affiliation': 'Division of Psychological Medicine and Clinical Neurosciences, Medical Research Council Centre for Neuropsychiatric Genetics and Genomics, Cardiff University, Cardiff, Wales, United Kingdom.'}, {'ForeName': 'Sharon A', 'Initials': 'SA', 'LastName': 'Simpson', 'Affiliation': 'Medical Research Council/Chief Scientist Office Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Glasgow, Scotland, United Kingdom.'}]",JMIR mental health,['10.2196/14536']
63,32385061,"Effect of PIFR-based optimised inhalation therapy in patients recovering from acute exacerbation of chronic obstructive pulmonary disease: protocol of a prospective, multicentre, superiority, randomised controlled trial.","INTRODUCTION


Acute exacerbation (AE) is a major cause of disease progression and death in patients with chronic obstructive pulmonary disease (COPD), accounting for majority of medical expenditures. Correct inhalation therapy is effective in preventing AE attacks. However, inappropriate usage of dry powder inhaler, partially due to the unrecovered peak inhalation flow rate (PIFR) after acute exacerbation of COPD (AECOPD), results in increased risk of early treatment failure. Therefore, we designed a multicentre, randomised clinical trial to determine whether PIFR-based optimised inhalation therapy and training on inhaler usage at discharge could effectively reduce early treatment failure events.
METHODS AND ANALYSIS


A total of 416 hospitalised patients just recovering from AECOPD will be recruited and equally randomised into the PIFR group and the control group at a 1:1 ratio. The PIFR group will receive additive support before discharge, including choice of PIFR-guided inhaler and education on its usage. PIFR is measured by InCheck DIAL. In comparison, the control group will receive inhalers based on judgement of the respiratory physician. The primary outcome of the study is 30-day treatment failure rate. Other endpoints include PIFR, error rate of inhalation device use, satisfaction with inhalation devices, 30-day mortality, 90-day mortality, symptoms and quality of life of patients, and COPD-related treatment costs.
ETHICS AND DISSEMINATION


The trial has been approved by the Ethics Committee of Zhongshan Hospital of Fudan University (B2019-142). Participants will be screened and enrolled from hospitalised patients with AECOPD by clinicians, with no public advertisement for recruitment. After the trial has completed, the results will be reported to the public through conference presentations and peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT04000958.",2020,"Other endpoints include PIFR, error rate of inhalation device use, satisfaction with inhalation devices, 30-day mortality, 90-day mortality, symptoms and quality of life of patients, and COPD-related treatment costs.
","['patients with chronic obstructive pulmonary disease (COPD', 'Participants will be screened and enrolled from hospitalised patients with AECOPD by clinicians, with no public advertisement for recruitment', '416 hospitalised patients just recovering from AECOPD', 'patients recovering from acute exacerbation of chronic obstructive pulmonary disease']","['PIFR-based optimised inhalation therapy and training', 'PIFR-based optimised inhalation therapy']","['30-day treatment failure rate', 'risk of early treatment failure', 'PIFR', 'peak inhalation flow rate (PIFR', 'PIFR, error rate of inhalation device use, satisfaction with inhalation devices, 30-day mortality, 90-day mortality, symptoms and quality of life of patients, and COPD-related treatment costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021459', 'cui_str': 'Inhalation therapy procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0021455', 'cui_str': 'Inhalation Devices'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}]",416.0,0.260112,"Other endpoints include PIFR, error rate of inhalation device use, satisfaction with inhalation devices, 30-day mortality, 90-day mortality, symptoms and quality of life of patients, and COPD-related treatment costs.
","[{'ForeName': 'Jianlan', 'Initials': 'J', 'LastName': 'Hua', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Zhongshan Hospital Fudan University, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Fudan University, Shanghai, China.'}, {'ForeName': 'Hui-Fang', 'Initials': 'HF', 'LastName': 'Cao', 'Affiliation': ""Department of Pulmonary, Shanghai Jing'an District Central Hospital, Shanghai, China, Shanghai, China.""}, {'ForeName': 'Chun-Ling', 'Initials': 'CL', 'LastName': 'Du', 'Affiliation': 'Department of Pulmonary, Shanghai Qingpu District Central Hospital, Shanghai, China.'}, {'ForeName': 'Jia-Yun', 'Initials': 'JY', 'LastName': 'Ma', 'Affiliation': ""Department of Pulmonary, North Branch of Shanghai Ninth People's Hospital, Shanghai, China.""}, {'ForeName': 'Yi-Hui', 'Initials': 'YH', 'LastName': 'Zuo', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Zhongshan Hospital Fudan University, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Zhongshan Hospital Fudan University, Shanghai, China jingatlas@hotmail.com.'}]",BMJ open,['10.1136/bmjopen-2019-034804']
64,32385063,Cow's Milk Fat Obesity pRevention Trial (CoMFORT): a primary care embedded randomised controlled trial protocol to determine the effect of cow's milk fat on child adiposity.,"INTRODUCTION


Cow's milk is a dietary staple for children in North America. Though clinical guidelines suggest children transition from whole (3.25% fat) milk to reduced (1% or 2%) fat milk at age 2 years, recent epidemiological evidence supports a link between whole milk consumption and lower adiposity in children. The purpose of this trial is to determine which milk fat recommendation minimises excess adiposity and optimises child nutrition and growth.
METHODS AND ANALYSIS


Cow's Milk Fat Obesity pRevention Trial will be a pragmatic, superiority, parallel group randomised controlled trial involving children receiving routine healthcare aged 2 to 4-5 years who are participating in the TARGet Kids! practice-based research network in Toronto, Canada. Children (n=534) will be randomised to receive one of two interventions: (1) a recommendation to consume whole milk or (2) a recommendation to consume reduced (1%) fat milk. The primary outcome is adiposity measured by body mass index z-score and waist circumference z-score; secondary outcomes will be cognitive development (using the Ages and Stages Questionnaire), vitamin D stores, cardiometabolic health (glucose, high-sensitivity C-reactive protein, non-high density lipoprotein (non-HDL), low density lipoprotein (LDL), triglyceride, HDL and total cholesterol, insulin and diastolic and systolic blood pressure), sugary beverage and total energy intake (measured by 24 hours dietary recall) and cost effectiveness. Outcomes will be measured 24 months postrandomisation and compared using analysis of covariance (ANCOVA), adjusting for baseline measures.
ETHICS AND DISSEMINATION


Ethics approval has been obtained from Unity Health Toronto and The Hospital for Sick Children. Results will be presented locally, nationally and internationally and published in a peer-reviewed journal. The findings may be helpful to nutrition guidelines for children in effort to reduce childhood obesity using a simple, inexpensive and scalable cow's milk fat intervention.
TRIAL REGISTRATION NUMBER


NCT03914807; pre-results.",2020,"vitamin D stores, cardiometabolic health (glucose, high-sensitivity C-reactive protein, non-high density lipoprotein (non-HDL), low density lipoprotein (LDL), triglyceride, HDL and total cholesterol, insulin and diastolic and systolic blood pressure), sugary beverage and total energy intake (measured by 24 hours dietary recall) and cost effectiveness.","['Children (n=534', 'children in North America', 'children receiving routine healthcare aged 2 to 4-5 years who are participating in the TARGet Kids', 'child adiposity']","[""cow's milk fat"", 'recommendation to consume whole milk or (2) a recommendation to consume reduced (1%) fat milk']","['adiposity measured by body mass index z-score and waist circumference z-score; secondary outcomes will be cognitive development (using the Ages and Stages Questionnaire', 'vitamin D stores, cardiometabolic health (glucose, high-sensitivity C-reactive protein, non-high density lipoprotein (non-HDL), low density lipoprotein (LDL), triglyceride, HDL and total cholesterol, insulin and diastolic and systolic blood pressure), sugary beverage and total energy intake']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C3256606', 'cui_str': 'milk fat, cow'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0452717', 'cui_str': 'Whole milk'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1535899', 'cui_str': 'Non-high-density lipoprotein cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",534.0,0.221937,"vitamin D stores, cardiometabolic health (glucose, high-sensitivity C-reactive protein, non-high density lipoprotein (non-HDL), low density lipoprotein (LDL), triglyceride, HDL and total cholesterol, insulin and diastolic and systolic blood pressure), sugary beverage and total energy intake (measured by 24 hours dietary recall) and cost effectiveness.","[{'ForeName': 'Shelley M', 'Initials': 'SM', 'LastName': 'Vanderhout', 'Affiliation': 'Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Aglipay', 'Affiliation': ""Pediatrics, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Birken', 'Affiliation': 'Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': ""O'Connor"", 'Affiliation': 'Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Thorpe', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Constantin', 'Affiliation': 'Department of Pediatrics, Mcgill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Marie-Adele', 'Initials': 'MA', 'LastName': 'Davis', 'Affiliation': 'Canadian Paediatric Society, Ottawa, Ontario, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Feldman', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Geoff D C', 'Initials': 'GDC', 'LastName': 'Ball', 'Affiliation': 'University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Janus', 'Affiliation': 'Offord Centre for Child Studies, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Junker', 'Affiliation': 'Pediatrics, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Laupacis', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': ""L'Abbé"", 'Affiliation': 'Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Manson', 'Affiliation': 'Health Promotion, Chronic Disease and Injury Prevention, Public Health Ontario, Ottawa, Ontario, Canada.'}, {'ForeName': 'Myla E', 'Initials': 'ME', 'LastName': 'Moretti', 'Affiliation': 'Clinical Trials Unit, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Nav', 'Initials': 'N', 'LastName': 'Persaud', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Omand', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Relton', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wong', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Yamashiro', 'Affiliation': 'Ontario Medical Association, Toronto, Ontario, Canada.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Tavares', 'Affiliation': 'Patient Partner, Toronto, Ontario, Canada.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Weir', 'Affiliation': 'Patient Partner, Toronto, Ontario, Canada.'}, {'ForeName': 'Jonathon L', 'Initials': 'JL', 'LastName': 'Maguire', 'Affiliation': 'Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada jonathon.maguire@utoronto.ca.'}]",BMJ open,['10.1136/bmjopen-2019-035241']
65,32385134,Levetiracetam Versus Phenobarbital for Neonatal Seizures: A Randomized Controlled Trial.,"BACKGROUND AND OBJECTIVES


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


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


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


In this phase IIb study, phenobarbital was more effective than levetiracetam for the treatment of neonatal seizures. Higher rates of adverse effects were seen with phenobarbital treatment. Higher-dose studies of levetiracetam are warranted, and definitive studies with long-term outcome measures are needed.",2020,"More adverse effects were seen in subjects randomly assigned to phenobarbital (not statistically significant).
","['Neonatal Seizures', 'neonatal seizures of any cause', 'older patients']","['levetiracetam', 'phenobarbital', 'Phenobarbital and phenytoin', 'Levetiracetam', 'Levetiracetam Versus Phenobarbital']","['complete seizure freedom for 24 hours, assessed by independent review of the EEGs by 2 neurophysiologists', 'phenobarbital remained seizure free', 'efficacy and safety', 'efficacy', 'adverse effects']","[{'cui': 'C0159020', 'cui_str': 'Convulsions in the newborn'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0031412', 'cui_str': 'Phenobarbital'}, {'cui': 'C0031507', 'cui_str': 'Phenytoin'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0699752', 'cui_str': 'Review of'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0031412', 'cui_str': 'Phenobarbital'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.327532,"More adverse effects were seen in subjects randomly assigned to phenobarbital (not statistically significant).
","[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Sharpe', 'Affiliation': ""Department of Paediatric Neurology, Starship Children's Health, Auckland, New Zealand.""}, {'ForeName': 'Gail E', 'Initials': 'GE', 'LastName': 'Reiner', 'Affiliation': ""Department of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California.""}, {'ForeName': 'Suzanne L', 'Initials': 'SL', 'LastName': 'Davis', 'Affiliation': ""Department of Paediatric Neurology, Starship Children's Health, Auckland, New Zealand.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Nespeca', 'Affiliation': ""Department of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California.""}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Gold', 'Affiliation': ""Department of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California.""}, {'ForeName': 'Maynard', 'Initials': 'M', 'LastName': 'Rasmussen', 'Affiliation': 'San Diego Neonatology Inc and.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kuperman', 'Affiliation': ""Pediatric Neurology, University of California, San Francisco Benioff Children's Hospital Oakland, Oakland, California.""}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Harbert', 'Affiliation': 'Department of Neurosciences, School of Medicine, University of California, San Diego and Sharp Mary Birch Hospital for Women & Newborns, San Diego, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Michelson', 'Affiliation': ""Division of Pediatric Neurology, Department of Pediatrics, Loma Linda University Children's Hospital, Loma Linda, California.""}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Joe', 'Affiliation': 'Division of Neonatology, Departments of Pediatrics and.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California.""}, {'ForeName': 'Neggy', 'Initials': 'N', 'LastName': 'Rismanchi', 'Affiliation': ""Department of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California.""}, {'ForeName': 'Ngoc Minh', 'Initials': 'NM', 'LastName': 'Le', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, California.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Mower', 'Affiliation': ""Department of Neurology, Children's Hospital of Orange County, Orange, California.""}, {'ForeName': 'Jae', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Division of NeoNatology, Departments of Pediatrics and.'}, {'ForeName': 'Malcolm R', 'Initials': 'MR', 'LastName': 'Battin', 'Affiliation': 'Department of Neonatology, Auckland District Health Board, Auckland, New Zealand; and.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lane', 'Affiliation': ""Division of Neonatology, Departments of Pediatrics, University of California, San Diego and Rady Children's Hospital San Diego, San Diego, California.""}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Honold', 'Affiliation': ""Division of Neonatology, Departments of Pediatrics, University of California, San Diego and Rady Children's Hospital San Diego, San Diego, California.""}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Knodel', 'Affiliation': ""Division of Neonatology, Departments of Pediatrics, University of California, San Diego and Rady Children's Hospital San Diego, San Diego, California.""}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Arnell', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, California.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Bridge', 'Affiliation': 'Division of NeoNatology, Departments of Pediatrics and.'}, {'ForeName': 'Lilly', 'Initials': 'L', 'LastName': 'Lee', 'Affiliation': 'Neurosciences, School of Medicine, University of California, San Diego, San Diego, California.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Ernstrom', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, Keck School of Medicine, University of Southern California, Los Angeles, California.""}, {'ForeName': 'Rema', 'Initials': 'R', 'LastName': 'Raman', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, Keck School of Medicine, University of Southern California, Los Angeles, California.""}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Haas', 'Affiliation': ""Department of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California; rhaas@health.ucsd.edu.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatrics,['10.1542/peds.2019-3182']
66,32376754,"Prospective, single-centre, randomised controlled trial to evaluate the efficacy and safety of ischaemia-free liver transplantation (IFLT) in the treatment of end-stage liver disease.","INTRODUCTION


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


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


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


ChiCTR1900021158.",2020,"After a 12-month follow-up of the last enrolled recipient, the outcomes will be analysed to evaluate the safety and efficacy of IFLT versus CLT in patients with end-stage liver disease.
","['patients with end-stage liver disease', 'end-stage liver disease', 'Adult patients (aged 18-75 years) eligible for liver transplantation']","['CLT', 'ischaemia-free liver transplantation (IFLT', 'IFLT', 'IFLT versus CLT', 'conventional liver transplantation (CLT), ischaemia-reperfusion injury (IRI']","['efficacy and safety', 'safety and efficacy', 'incidence of EAD after liver transplantation', 'postoperative liver graft function, complications and recipient and graft survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0745744', 'cui_str': 'End stage liver disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-reperfusion injury'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}]",,0.0805885,"After a 12-month follow-up of the last enrolled recipient, the outcomes will be analysed to evaluate the safety and efficacy of IFLT versus CLT in patients with end-stage liver disease.
","[{'ForeName': 'Changjun', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Shanzhou', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yunhua', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Dongping', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Weiqiang', 'Initials': 'W', 'LastName': 'Ju', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Linwei', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Maogen', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhiheng', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zebin', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Linhe', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Caihui', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yixi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Chengjun', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xiong', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yuekun', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xiaoxiang', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Anbin', 'Initials': 'A', 'LastName': 'Hu', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Rong', 'Affiliation': 'Department of Cardiopulmonary Bypass, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Changjie', 'Initials': 'C', 'LastName': 'Cai', 'Affiliation': 'Surgical Intensive Care Unit, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China gdtrc@163.com rockyucsf1981@126.com.'}, {'ForeName': 'Xiaoshun', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China gdtrc@163.com rockyucsf1981@126.com.'}]",BMJ open,['10.1136/bmjopen-2019-035374']
67,32383125,Post-exposure prophylaxis or pre-emptive therapy for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): study protocol for a pragmatic randomized-controlled trial.,"BACKGROUND


The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in December 2019 causing the coronavirus disease (COVID-19) pandemic. Currently, there is a lack of evidence-based therapies to prevent COVID-19 following exposure to the virus, or to prevent worsening of symptoms following confirmed infection. We describe the design of a clinical trial of hydroxychloroquine for post-exposure prophylaxis (PEP) and pre-emptive therapy (PET) for COVID-19.
METHODS


We will conduct two nested multicentre international double-blind randomized placebo-controlled clinical trials of hydroxychloroquine for: 1) PEP of asymptomatic household contacts or healthcare workers exposed to COVID-19 within the past four days, and 2) PET for symptomatic outpatients with COVID-19 showing symptoms for less than four days. We will recruit 1,500 patients each for the PEP and PET trials. Participants will be randomized 1:1 to receive five days of hydroxychloroquine or placebo. The primary PEP trial outcome will be the incidence of symptomatic COVID-19. The primary PET trial outcome will be an ordinal scale of disease severity (not hospitalized, hospitalized without intensive care, hospitalization with intensive care, or death). Participant screening, informed consent, and follow-up will be exclusively internet-based with appropriate regulatory and research ethics board approvals in Canada and the United States.
DISCUSSION


These complementary randomized-controlled trials are innovatively designed and adequately powered to rapidly answer urgent questions regarding the effectiveness of hydroxychloroquine to reduce virus transmission and disease severity of COVID-19 during a pandemic. In-person participant follow-up will not be conducted to facilitate social distancing strategies and reduce risks of exposure to study personnel. Innovative trial approaches are needed to urgently assess therapeutic options to mitigate the global impact of this pandemic.
TRIALS REGISTRATION


clinicaltrials.gov (NCT04308668); registered 16 March, 2020.",2020,In-person participant follow-up will not be conducted to facilitate social distancing strategies and reduce risks of exposure to study personnel.,"['severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2', 'symptomatic outpatients with COVID-19 showing symptoms for less than four days', '1,500 patients each for the PEP and PET trials']","['hydroxychloroquine or placebo', 'Post-exposure prophylaxis or pre-emptive therapy', 'hydroxychloroquine', 'hydroxychloroquine for post-exposure prophylaxis (PEP) and pre-emptive therapy (PET', 'placebo']","['incidence of symptomatic COVID-19', 'ordinal scale of disease severity (not hospitalized, hospitalized without intensive care, hospitalization with intensive care, or death']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1443861', 'cui_str': 'Post-exposure prophylaxis'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1443861', 'cui_str': 'Post-exposure prophylaxis'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1500.0,0.697151,In-person participant follow-up will not be conducted to facilitate social distancing strategies and reduce risks of exposure to study personnel.,"[{'ForeName': 'Sylvain A', 'Initials': 'SA', 'LastName': 'Lother', 'Affiliation': 'Department of Internal Medicine, Section of Critical Care, University of Manitoba, Winnipeg, MB, Canada. slother@manitoba-physicians.ca.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Abassi', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Agostinis', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Cheng', 'Affiliation': 'Divisions of Infectious Diseases & Medical Microbiology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Drobot', 'Affiliation': 'Department of Medicine, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Engen', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Kathy H', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Kelly', 'Affiliation': 'Department of Pediatrics and Child Health, Department of Pharmacology, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Lofgren', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'MacKenzie', 'Affiliation': 'Section of Infectious Diseases, Department of Internal Medicine, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Marten', 'Affiliation': 'Critical Care Research, St-Boniface Hospital, Winnipeg, MB, Canada.'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Okafor', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Pullen', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Schwartz', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Alexis F', 'Initials': 'AF', 'LastName': 'Turgeon', 'Affiliation': 'CHU de Québec - Université Laval Research Centre, Population Health and Optimal Health Practices Research Unit Trauma - Emergency - Critical Care Medicine, Université Laval, Quebec, QC, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarychanski', 'Affiliation': 'Department of Internal Medicine, Section of Critical Care, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-020-01684-7']
68,32390583,Comparing Training Techniques in Personal Protective Equipment Use.,"INTRODUCTION


Physicians' management of hazardous material (HAZMAT) incidents requires personal protective equipment (PPE) utilization to ensure the safety of victims, facilities, and providers; therefore, providing effective and accessible training in its use is crucial. While an emphasis has been placed on the importance of PPE, there is debate about the most effective training methods. Circumstances may not allow for a traditional in-person demonstration; an accessible video training may provide a useful alternative.
HYPOTHESIS


Video training of Emergency Medicine (EM) residents in the donning and doffing of Level C PPE is more effective than in-person training.
NULL HYPOTHESIS


Video training of EM residents in the donning and doffing of Level C PPE is equally effective compared with in-person training.
METHODS


A randomized, controlled pilot trial was performed with 20 EM residents as part of their annual Emergency Preparedness training. Residents were divided into four groups, with Group 1 and Group 2 viewing a demonstration video developed by the Emergency Preparedness Team (EPT) and Group 3 and Group 4 receiving the standard in-person demonstration training by an EPT member. The groups then separately performed a donning and doffing simulation while blinded evaluators assessed critical tasks utilizing a prepared evaluation tool. At the drill's conclusion, all participants also completed a self-evaluation survey about their subjective interpretations of their respective trainings.
RESULTS


Both video and in-person training modalities showed significant overall improvement in participants' confidence in doffing and donning PPE equipment (P <.05). However, no statistically significant difference was found in the number of failed critical tasks in donning or doffing between the training modalities (P >.05). Based on these results, the null hypothesis cannot be rejected. However, these results were limited by the small sample size and the study was not sufficiently powered to show a difference between training modalities.
CONCLUSION


In this pilot study, video and in-person training were equally effective in training for donning and doffing Level C PPE, with similar error rates in both modalities. Further research into this subject with an appropriately powered study is warranted to determine whether this equivalence persists using a larger sample size.",2020,Both video and in-person training modalities showed significant overall improvement in participants' confidence in doffing and donning PPE equipment (P <.05).,['20 EM residents as part of their annual Emergency Preparedness training'],['Group 1 and Group 2 viewing a demonstration video developed by the Emergency Preparedness Team (EPT) and Group 3 and Group 4 receiving the standard in-person demonstration training by an EPT member'],['number of failed critical tasks'],"[{'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1956344', 'cui_str': 'Emergency Preparedness'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1956344', 'cui_str': 'Emergency Preparedness'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0680022', 'cui_str': 'Member of'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}]",,0.0356448,Both video and in-person training modalities showed significant overall improvement in participants' confidence in doffing and donning PPE equipment (P <.05).,"[{'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Salway', 'Affiliation': 'New York Health and Hospitals, Office of Quality and Safety, New York, New York, USA.'}, {'ForeName': 'Trenika', 'Initials': 'T', 'LastName': 'Williams', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, New HampshireUSA.'}, {'ForeName': 'Camilo', 'Initials': 'C', 'LastName': 'Londono', 'Affiliation': 'SUNY Downstate College of Medicine, Brooklyn, New YorkUSA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Roblin', 'Affiliation': 'SUNY Downstate College of Medicine, Brooklyn, New YorkUSA.'}, {'ForeName': 'Kristi', 'Initials': 'K', 'LastName': 'Koenig', 'Affiliation': 'Center for Disaster Medical Sciences, University of California - Irvine School of Medicine, Irvine, CaliforniaUSA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Arquilla', 'Affiliation': 'SUNY Downstate College of Medicine, Brooklyn, New YorkUSA.'}]",Prehospital and disaster medicine,['10.1017/S1049023X20000564']
69,32387716,Hypertension during Diabetic Ketoacidosis in Children.,"OBJECTIVES


To characterize hemodynamic alterations occurring during diabetic ketoacidosis (DKA) in a large cohort of children and to identify clinical and biochemical factors associated with hypertension.
STUDY DESIGN


This was a planned secondary analysis of data from the Pediatric Emergency Care Applied Research Network Fluid Therapies Under Investigation in DKA Study, a randomized clinical trial of fluid resuscitation protocols for children in DKA. Hemodynamic data (heart rate, blood pressure) from children with DKA were assessed in comparison with normal values for age and sex. Multivariable statistical modeling was used to explore clinical and laboratory predictors of hypertension.
RESULTS


Among 1258 DKA episodes, hypertension was documented at presentation in 154 (12.2%) and developed during DKA treatment in an additional 196 (15.6%), resulting in a total of 350 DKA episodes (27.8%) in which hypertension occurred at some time. Factors associated with hypertension at presentation included more severe acidosis, (lower pH and lower pCO 2 ), and stage 2 or 3 acute kidney injury. More severe acidosis and lower Glasgow Coma Scale scores were associated with hypertension occurring at any time during DKA treatment.
CONCLUSIONS


Despite dehydration, hypertension occurs in a substantial number of children with DKA. Factors associated with hypertension include greater severity of acidosis, lower pCO 2,  and lower Glasgow Coma Scale scores during DKA treatment, suggesting that hypertension might be centrally mediated.",2020,"More severe acidosis and lower Glasgow Coma Scale (GCS) scores were associated with hypertension occurring at any time during DKA treatment.
","['children with DKA', 'children in DKA', 'Hypertension During Diabetic Ketoacidosis in Children']",[],"['severity of acidosis, lower PCO 2  and lower GCS scores', 'Hemodynamic data (heart rate, blood pressure', 'severe acidosis and lower Glasgow Coma Scale (GCS) scores', 'hypertension']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",[],"[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0001122', 'cui_str': 'Acidosis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",,0.0665684,"More severe acidosis and lower Glasgow Coma Scale (GCS) scores were associated with hypertension occurring at any time during DKA treatment.
","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'DePiero', 'Affiliation': 'Division of Emergency Medicine, Department of Pediatrics, Nemours/A.I. DuPont Hospital for Children, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Kuppermann', 'Affiliation': 'Department of Emergency Medicine, University of California Davis Health, University of California Davis, School of Medicine, Sacramento, CA; Department of Pediatrics, University of California Davis Health, University of California Davis, School of Medicine, Sacramento, CA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Brown', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Children's National Medical Center, The George Washington School of Medicine and Health Sciences, Washington, DC.""}, {'ForeName': 'Jeff E', 'Initials': 'JE', 'LastName': 'Schunk', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Julie K', 'Initials': 'JK', 'LastName': 'McManemy', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Texas Children's Hospital, Baylor College of Medicine, Houston, TX.""}, {'ForeName': 'Arleta', 'Initials': 'A', 'LastName': 'Rewers', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, The Colorado Children's Hospital, University of Colorado-Denver School of Medicine, Denver, CO.""}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Stoner', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Nationwide Children's Hospital, The Ohio State University School of Medicine, Columbus, OH.""}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Tzimenatos', 'Affiliation': 'Department of Emergency Medicine, University of California Davis Health, University of California Davis, School of Medicine, Sacramento, CA.'}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Garro', 'Affiliation': 'Departments of Emergency Medicine and Pediatrics, Rhode Island Hospital, The Warren Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Sage R', 'Initials': 'SR', 'LastName': 'Myers', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Kimberly S', 'Initials': 'KS', 'LastName': 'Quayle', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, St. Louis Children's Hospital, Washington University School of Medicine in St. Louis, St. Louis, MO.""}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Trainor', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, IL.""}, {'ForeName': 'Maria Y', 'Initials': 'MY', 'LastName': 'Kwok', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, New York Presbyterian Morgan Stanley Children's Hospital, Columbia University College of Physicians and Surgeons, New York, NY.""}, {'ForeName': 'Lise E', 'Initials': 'LE', 'LastName': 'Nigrovic', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Boston Children's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Cody S', 'Initials': 'CS', 'LastName': 'Olsen', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'T Charles', 'Initials': 'TC', 'LastName': 'Casper', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Ghetti', 'Affiliation': 'Department of Psychology, University of California Davis, Sacramento, CA.'}, {'ForeName': 'Nicole S', 'Initials': 'NS', 'LastName': 'Glaser', 'Affiliation': 'Department of Pediatrics, University of California Davis Health, University of California Davis, School of Medicine, Sacramento, CA. Electronic address: nsglaser@ucdavis.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.04.066']
70,32387055,Timing of Peak Vision Gains in Patients with Neovascular Age-Related Macular Degeneration Treated with Ranibizumab.,"PURPOSE


To investigate whether time to peak best-corrected visual acuity (BCVA) was predictive of magnitude of BCVA changes at study end in patients with neovascular age-related macular degeneration (nAMD) who received ranibizumab and assess whether patient baseline characteristics and on-study events were predictive of time to peak BCVA.
DESIGN


Exploratory analysis of data from HARBOR (ClinicalTrials.gov identifier, NCT00891735).
PARTICIPANTS


Treatment-naïve patients 50 years of age or older with subfoveal nAMD.
METHODS


Data by ranibizumab dose were pooled; data by dosing schedule (pro re nata [PRN] and monthly) were evaluated separately. Time to peak BCVA was the monthly evaluation at which the patient's greatest gain in Early Treatment Diabetic Retinopathy Study (ETDRS) letters from baseline was achieved. Early peakers achieved peak BCVA between day 7 and month 6; late peakers achieved peak BCVA between months 7 and 12, months 13 and 18, and months 19 and 24. Variables evaluated for effect of time to peak BCVA included baseline demographic and clinical characteristics, presence of persistent subretinal fluid (SRF) or intraretinal fluid (IRF), and on-study events (atrophy status, fibrosis, retinal pigment epithelium tears).
MAIN OUTCOME MEASURES


Time to peak BCVA and its predictive value for magnitude of BCVA changes and BCVA at month 24 (study end).
RESULTS


Most patients reached peak BCVA after more than 6 months of treatment: 64% in the PRN group (301/474) and 70% in the monthly groups (327/469). Thirty-six percent and 30% of patients, respectively, peaked early, and 64% and 70%, respectively, peaked late. At month 24, early peakers on average lost vision (PRN, -1.6 ETDRS letters; monthly, -1.9 ETDRS letters). By contrast, late peakers achieved significantly better vision gains from baseline (PRN, 8.5-17.7 ETDRS letters; monthly, 10.1-18.7 ETDRS letters). No differences were found in patient characteristics, persistent SRF or IRF, or on-study events to account for the observed different outcomes between early and late peakers.
CONCLUSIONS


In most treatment-naïve patients with nAMD, vision gains were achieved at a slower rate (>6 months), and a slower response was associated with better vision outcomes after 24 months of ranibizumab. These findings suggest that continued treatment may result in greater vision improvements when consistent anti-vascular endothelial growth factor therapy is maintained over a longer period.",2020,"In most treatment-naïve patients with nAMD, vision gains were achieved at a slower rate (>6 months), and a slower response was associated with better vision outcomes after 24 months of ranibizumab.","['Patients with Neovascular Age-Related Macular Degeneration Treated with', 'patients with neovascular age-related macular degeneration (nAMD) who received', 'Treatment-naïve patients 50 years of age or older with subfoveal nAMD']","['Ranibizumab', 'ranibizumab']","['baseline demographic and clinical characteristics, presence of persistent subretinal fluid (SRF) or intraretinal fluid (IRF), and on-study events (atrophy status, fibrosis, retinal pigment epithelium\xa0tears', 'time to peak best-corrected visual acuity (BCVA', 'peak BCVA', 'Time to peak BCVA and its predictive value for magnitude of BCVA changes and BCVA', 'average lost vision', 'vision outcomes', 'vision gains', 'patient characteristics, persistent SRF or IRF', 'vision improvements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C4531067', 'cui_str': 'Intraretinal fluid'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",,0.134321,"In most treatment-naïve patients with nAMD, vision gains were achieved at a slower rate (>6 months), and a slower response was associated with better vision outcomes after 24 months of ranibizumab.","[{'ForeName': 'Rahul N', 'Initials': 'RN', 'LastName': 'Khurana', 'Affiliation': 'Northern California Retina Vitreous Associates, Mountain View, California. Electronic address: rnkhurana@gmail.com.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Chang', 'Affiliation': 'Northern California Retina Vitreous Associates, Mountain View, California.'}, {'ForeName': 'Bann-Mo', 'Initials': 'BM', 'LastName': 'Day', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Avanti', 'Initials': 'A', 'LastName': 'Ghanekar', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Ivaylo', 'Initials': 'I', 'LastName': 'Stoilov', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.02.011']
71,32389019,Effects of auricular acupuncture on appetite in patients with advanced cancer: a pilot randomized controlled trial.,"BACKGROUND


Over half of patients with advanced cancer report appetite loss or anorexia. Previous studies have shown the benefit of acupuncture for cancer-related nausea and vomiting, but limited evidence exists for its role in appetite improvement. Our study aimed to evaluate the feasibility and safety of auricular acupuncture to improve appetite for cancer patients with advanced disease.
METHODS


We performed a two-arm parallel, pilot randomized controlled trial (RCT) of auricular acupuncture versus usual care control in patients with stage III or IV cancer who experienced appetite loss. The primary outcome was changed in the Simplified Nutritional Appetite Questionnaire (SNAQ; score range, 4-20) between two groups from baseline to weeks 2 and 4, with secondary outcomes including change in weight, as well as an additional evaluation at week 8 for durability of treatment effects. We used independent two-sample t-test for the change in mean score for each outcome during or after treatment. We assessed the interaction between time and treatment from baseline to weeks 2, 4, and 8 using mixed-effects models by ANOVA test.
RESULTS


We randomized 55 patients to auricular acupuncture (N=27) or control group (N=28). By week 4, the auricular acupuncture group had a significantly higher escalation in the SNAQ score than the control group compared with baseline [mean difference 3.69; 95% confidential interval (95% CI): 2.5, 4.8; P<0.001] and experienced a 51.4% improvement in appetite. From baseline to weeks 2 and 4, patients lost a little weight in the control group but gained weight in the auricular acupuncture group. Between baseline and week 4, change in the SNAQ score was significantly associated with change in weight (P=0.001). No adverse events (AEs) were reported during the study.
CONCLUSIONS


Compared to usual care, auricular acupuncture is feasible and safe to improve appetite and help patients with advanced cancer gain weight.",2020,"By week 4, the auricular acupuncture group had a significantly higher escalation in the SNAQ score than the control group compared with baseline [mean difference 3.69; 95% confidential interval (95% CI): 2.5, 4.8; P<0.001] and experienced a 51.4% improvement in appetite.","['patients with advanced cancer', 'N=27) or control group (N=28', 'patients with advanced cancer gain weight', 'patients with stage III or IV cancer who experienced appetite loss', 'cancer patients with advanced disease', 'patients with advanced cancer report appetite loss or anorexia']","['usual care, auricular acupuncture', 'acupuncture', 'auricular acupuncture']","['Simplified Nutritional Appetite Questionnaire (SNAQ; score range, 4-20', 'SNAQ score', 'appetite', 'change in weight, as well as an additional evaluation at week 8 for durability of treatment effects', 'feasibility and safety', 'gained weight']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0752217', 'cui_str': 'Ear Acupuncture'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",55.0,0.345349,"By week 4, the auricular acupuncture group had a significantly higher escalation in the SNAQ score than the control group compared with baseline [mean difference 3.69; 95% confidential interval (95% CI): 2.5, 4.8; P<0.001] and experienced a 51.4% improvement in appetite.","[{'ForeName': 'Lingyun', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Clinical Cancer Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Jun J', 'Initials': 'JJ', 'LastName': 'Mao', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Bendheim Integrative Medicine Center, New York, NY, USA.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Integrative Chinese and Western Medicine, Cancer Hospital of Peking University, Beijing 100142, China.'}, {'ForeName': 'Yufei', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Clinical Cancer Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'He', 'Affiliation': 'Clinical Cancer Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China. hebinbj68@163.com.'}]",Annals of palliative medicine,['10.21037/apm.2020.04.24']
72,32393614,Can a teacher-led mindfulness intervention for new school entrants improve child outcomes? Protocol for a school cluster randomised controlled trial.,"INTRODUCTION


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


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


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


Australian New Zealand Clinical Trials Registry (ACTRN12619000326190).",2020,"The first years of school are critical in establishing a foundation for positive long-term academic, social and well-being outcomes.","[""826 students in the first year of primary school will be recruited to detect between groups differences of Cohen's d=0.25 at the 18-month follow-up"", '22 primary schools in disadvantaged areas of Melbourne, Australia']","['mindfulness intervention within the first years of primary school have better: (1) immediate attention/short-term memory at 18 months post-randomisation (primary outcome); (2) inhibition, working memory and cognitive flexibility at 18 months post-randomisation; (3) socio-emotional well-being, emotion-regulation and mental health-related behaviours at 6 and 18 months post-randomisation; (4) sustained changes in teacher practice and classroom interactions']","['child attention, emotion-regulation, executive functioning, socio-emotional well-being, mental health-related behaviour and learning, parent mental well-being, teacher well-being']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]",826.0,0.172604,"The first years of school are critical in establishing a foundation for positive long-term academic, social and well-being outcomes.","[{'ForeName': 'Jon L', 'Initials': 'JL', 'LastName': 'Quach', 'Affiliation': 'Melbourne Graduate School of Education, The University of Melbourne, Carlton, Victoria, Australia jon.quach@unimelb.edu.au.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Deery', 'Affiliation': 'Melbourne Graduate School of Education, The University of Melbourne, Carlton, Victoria, Australia.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Kern', 'Affiliation': 'Melbourne Graduate School of Education, The University of Melbourne, Carlton, Victoria, Australia.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Clinton', 'Affiliation': 'Melbourne Graduate School of Education, The University of Melbourne, Carlton, Victoria, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Gold', 'Affiliation': 'Deakin Health Economics, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Orsini', 'Affiliation': 'Clinical Epidemiology and Biostatistics Unit, Murdoch Childrens Research Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sciberras', 'Affiliation': 'Centre for Community Child Health, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-036523']
73,32393616,Correction: Acupuncture for insomnia with short sleep duration: protocol for a randomised controlled trial.,,2020,,['insomnia with short sleep duration'],['Correction: Acupuncture'],[],"[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]",[],,0.208285,,[],BMJ open,['10.1136/bmjopen-2019-033731corr1']
74,32385058,Cluster randomised controlled trial of home cook intervention to reduce salt intake in China: a protocol study.,"INTRODUCTION


Salt intake in China is twice the upper limit recommended by the WHO, and nearly 80% of salt is added during cooking. This study will develop a package of salt reduction interventions targeting home cooks and evaluate its effectiveness and feasibility for scale-up.
METHODS AND ANALYSIS


A cluster randomised controlled trial design is adopted in this study, which will be conducted in six provinces covering northern, central and southern China. For each province, 10 communities/villages (clusters) with 13 families (one cook and one adult family member) will be selected in each cluster for evaluation. In total, 780 home cooks and 780 adult family members will be recruited. The home cooks in the intervention group will be provided with the intervention package, including community-based standardised offline and online health education and salt intake monitoring. The duration of the intervention will be 1 year. The primary outcome is the difference between the intervention and control group in change in salt intake as measured by 24 hours urinary sodium from baseline to the end of the trial. The secondary outcome is the difference between the two groups in the change in salt-related knowledge, attitude and practice and blood pressure (BP).
ETHICS AND DISSEMINATION


The study has been approved by The Queen Mary Research Ethics Committee (QMERC2018/13) and Institutional Review Board of the Chinese Center for Disease Control and Prevention (No. 201801). The study findings will be disseminated widely through conference presentations and peer-reviewed publications and the general media.
TRIAL REGISTRATION NUMBER


ChiCTR1800016804.",2020,"The secondary outcome is the difference between the two groups in the change in salt-related knowledge, attitude and practice and blood pressure (BP).
","['For each province, 10 communities/villages (clusters) with 13 families (one cook and one adult family member', 'China', 'six provinces covering northern, central and southern China', 'In total, 780 home cooks and 780 adult family members will be recruited']","['intervention package, including community-based standardised offline and online health education and salt intake monitoring', 'home cook intervention']","['change in salt intake', 'change in salt-related knowledge, attitude and practice and blood pressure (BP']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",,0.101015,"The secondary outcome is the difference between the two groups in the change in salt-related knowledge, attitude and practice and blood pressure (BP).
","[{'ForeName': 'Xiaochang', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Beijing Center for Diseases Prevention and Control, Beijing, China.'}, {'ForeName': 'Jixiang', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Chinese Center for Disease Control and Prevention, Beijing, China majx@chinacdc.cn zpuhong@georgeinstitute.org.cn.'}, {'ForeName': 'Puhong', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China majx@chinacdc.cn zpuhong@georgeinstitute.org.cn.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Luo', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Feng J', 'Initials': 'FJ', 'LastName': 'He', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Graham A', 'Initials': 'GA', 'LastName': 'MacGregor', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Jinglei', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Zhaoxue', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': 'Chinese Center for Disease Control and Prevention, Beijing, China.'}]",BMJ open,['10.1136/bmjopen-2019-033842']
75,32389574,"Pharmacokinetics and pharmacodynamics of JR-051, a biosimilar of agalsidase beta, in healthy adults and patients with Fabry disease: Phase I and II/III clinical studies.","Fabry disease is a rare X-linked lysosomal disease, in which mutations in the gene encoding α-galactosidase A result in progressive cellular accumulation of globotriaosylceramide (GL-3) in various organs including the skin, kidney, and heart, often leading to life-threatening conditions. Enzyme replacement therapy is currently the standard therapy for the disease, to which two α-galactosidase A formulations have been approved: agalsidase α (Replagal®, Shire) and agalsidase β (Fabrazyme®, Sanofi). We have recently developed a biosimilar of agalsidase β, JR-051, and investigated its pharmacokinetics and pharmacodynamics to assess its bioequivalence to agalsidase β. In a randomized phase I study, healthy adult male volunteers were treated with JR-051 or agalsidase β and the pharmacokinetics of the drugs were compared. The ratio of geometric means (90% confidence interval [CI]) of the AUC 0 - 24  and C max  for JR-051 over agalsidase β were 0.91 (0.8294, 1.0082) and 0.90 (0.7992, 1.0125), respectively. In a 52-week, single-arm, phase II/III study, patients with Fabry disease switched therapy from agalsidase β to JR-051 to evaluate its pharmacodynamics. The mean (95% CI) plasma GL-3 concentrations at weeks 26 and 52 relative to pre-JR-051 administration were 1.03 (0.91, 1.15) and 0.96 (0.86, 1.06), respectively, which were within the pre-determined bioequivalence acceptance range (0.70, 1.43). The mean (95% CI) plasma globotriaosylsphingosine (lyso-GL-3) concentrations at weeks 26 and 52 relative to pre-JR-051 administration were 1.07 (0.92, 1.23) and 1.13 (1.03, 1.22), respectively. Estimated glomerular filtration rate and left ventricular mass index, as renal and cardiac function indicators, showed no notable changes from baseline throughout the study period, and no new safety concerns were identified. In conclusion, these studies demonstrated bioequivalence of JR-051 to agalsidase β in terms of its pharmacokinetics and pharmacodynamics. JR-051 offers a potential new treatment option for patients with Fabry disease.",2020,"Estimated glomerular filtration rate and left ventricular mass index, as renal and cardiac function indicators, showed no notable changes from baseline throughout the study period, and no new safety concerns were identified.","['patients with Fabry disease', 'healthy adult male volunteers', 'healthy adults and patients with Fabry disease']","['JR-051', 'Enzyme replacement therapy', 'JR-051 or agalsidase β']","['ratio of geometric means', 'plasma globotriaosylsphingosine (lyso-GL-3) concentrations', 'Estimated glomerular filtration rate and left ventricular mass index, as renal and cardiac function indicators', 'plasma GL-3 concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002986', 'cui_str': ""Fabry's disease""}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0598391', 'cui_str': 'Enzyme Replacement Therapy'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0082711', 'cui_str': 'globotriaosyl lysosphingolipid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",,0.0337138,"Estimated glomerular filtration rate and left ventricular mass index, as renal and cardiac function indicators, showed no notable changes from baseline throughout the study period, and no new safety concerns were identified.","[{'ForeName': 'Kimitoshi', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Faculty of Life Sciences, Kumamoto University, 1-1-1 Honjo, Chuo-ku, Kumamoto, Japan. Electronic address: nakamura@kumamoto-u.ac.jp.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kawashima', 'Affiliation': 'Development Division, JCR Pharmaceuticals, 2-4 Kasuga-cho, Ashiya, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Tozawa', 'Affiliation': 'Development Division, JCR Pharmaceuticals, 2-4 Kasuga-cho, Ashiya, Japan.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Yamaoka', 'Affiliation': 'Development Division, JCR Pharmaceuticals, 2-4 Kasuga-cho, Ashiya, Japan.'}, {'ForeName': 'Tatsuyoshi', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Development Division, JCR Pharmaceuticals, 2-4 Kasuga-cho, Ashiya, Japan.'}, {'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Tanaka', 'Affiliation': 'Research Division, JCR Pharmaceuticals, 2-2-9 Murotani, Nishi-ku, Kobe, Japan.'}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Yamamoto', 'Affiliation': 'Research Division, JCR Pharmaceuticals, 2-2-9 Murotani, Nishi-ku, Kobe, Japan.'}, {'ForeName': 'Torayuki', 'Initials': 'T', 'LastName': 'Okuyama', 'Affiliation': 'National Centre for Child Health and Development, Japan.'}, {'ForeName': 'Yoshikatsu', 'Initials': 'Y', 'LastName': 'Eto', 'Affiliation': 'Advanced Clinical Research Centre & Asian Lysosome Storage Disorder Centre, Institute of Neurological Disorders, Japan.'}]",Molecular genetics and metabolism,['10.1016/j.ymgme.2020.04.003']
76,32393496,"A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of MHAA4549A, a Monoclonal Antibody, plus Oseltamivir in Patients Hospitalized with Severe Influenza A Virus Infection.","For patients hospitalized with severe influenza A virus infection, morbidity and mortality remain high. MHAA4549A, a human monoclonal antibody targeting the influenza A virus hemagglutinin stalk, has demonstrated pharmacological activity in animal studies and in a human influenza A challenge study. We evaluated the safety and efficacy of MHAA4549A plus oseltamivir against influenza A virus infection in hospitalized patients. The CRANE trial was a phase 2b randomized, double-blind, placebo-controlled study of single intravenous (i.v.) doses of placebo, 3,600 mg MHAA4549A, or 8,400 mg MHAA4549A each combined with oral oseltamivir (+OTV) in patients hospitalized with severe influenza A virus infection. Patients, enrolled across 68 clinical sites in 18 countries, were randomized 1:1:1. The primary outcome was the median time to normalization of respiratory function, defined as the time to removal of supplemental oxygen support to maintain a stable oxygen saturation (SpO 2 ) of ≥95%. Safety, pharmacokinetics, and effects on influenza viral load were also assessed. One hundred sixty-six patients were randomized and analyzed during a preplanned interim analysis. Compared to placebo+OTV, MHAA4549A+OTV did not significantly reduce the time to normalization of respiratory function (placebo+OTV, 4.28 days; 3,600 mg MHAA4549A+OTV, 2.78 days; 8,400 mg MHAA4549A+OTV, 2.65 days), nor did it improve other secondary clinical outcomes. Adverse event frequency was balanced across cohorts. MHAA4549A+OTV did not further reduce viral load versus placebo+OTV. In hospitalized patients with influenza A virus infection, MHAA4549A did not improve clinical outcomes over OTV alone. Variability in patient removal from oxygen supplementation limited the utility of the primary endpoint. Validated endpoints are needed to assess novel treatments for severe influenza A virus infection. (This study has been registered at ClinicalTrials.gov under registration no. NCT02293863.).",2020,"Compared to placebo+OTV, MHAA4549A+OTV did not significantly reduce the time to normalization of respiratory function (placebo+OTV: 4.28 days; 3600-mg MHAA4549A+OTV: 2.78 days; 8400-mg MHAA4549A+OTV: 2.65 days), nor did it improve other secondary clinical outcomes.","['patients hospitalized with severe influenza A. Patients, enrolled across 68 clinical sites in 18 countries', 'patients hospitalized with severe influenza A infection', 'hospitalized patients', '166 patients']","['MHAA4549A plus oseltamivir', 'placebo, 3600-mg, or 8400-mg MHAA4549A together with oral oseltamivir (+OTV', 'MHAA4549A', 'MHAA4549A+OTV', 'placebo+OTV, MHAA4549A+OTV', 'placebo']","['median time to normalization of respiratory function defined as the time to removal of supplemental oxygen support to maintain a stable SpO 2  ≥ 95', 'time to normalization of respiratory function', 'Safety, pharmacokinetics, and effects on influenza viral load', 'safety and efficacy', 'Adverse event frequency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1615607', 'cui_str': 'Influenza A virus subtype H1N1'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C5191361', 'cui_str': '166'}]","[{'cui': 'C5139963', 'cui_str': 'MHAA4549A'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",166.0,0.65193,"Compared to placebo+OTV, MHAA4549A+OTV did not significantly reduce the time to normalization of respiratory function (placebo+OTV: 4.28 days; 3600-mg MHAA4549A+OTV: 2.78 days; 8400-mg MHAA4549A+OTV: 2.65 days), nor did it improve other secondary clinical outcomes.","[{'ForeName': 'Jeremy J', 'Initials': 'JJ', 'LastName': 'Lim', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA lim.jeremy@gene.com.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Nilsson', 'Affiliation': 'Department of Translational Medicine, Infectious Diseases Research Unit, Lund University, Malmö, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverman', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Nimer', 'Initials': 'N', 'LastName': 'Assy', 'Affiliation': 'Galilee Medical Center, Department of Internal Med A, The Azrieli Faculty of Medicine, Nahariya, Israel.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Kulkarni', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'McBride', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Deng', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Nguyen', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Horn', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Maia', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Aide', 'Initials': 'A', 'LastName': 'Castro', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Melicent C', 'Initials': 'MC', 'LastName': 'Peck', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Galanter', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Chu', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Newton', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Tavel', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00352-20']
77,32393498,Plasmodium falciparum Isolates Carrying  pf k13 Polymorphisms Harbor the SVMNT Allele of  pfcrt  in Northwestern Indonesia.,"Artemisinin-based combination therapy (ACT) is the first-line antimalarial regimen in Indonesia. Susceptibility of  Plasmodium falciparum  to artemisinin is falling in the Greater Mekong subregion, but it is not known whether the efficacy of current combinations is also threatened in nearby Sumatera. We evaluated the genetic loci  pfcrt, pfmdr1 , and  pfk13 , considered to be under selection by artemisinin combination therapy, among 404  P. falciparum  infections identified by PCR detection in a cross-sectional survey of 3,731 residents of three regencies. The  pfcrt  haplotype SVMNT (codons 72 to 76) was the most prevalent and displayed significant linkage disequilibrium with the  pfmdr1  haplotype YY (codons 86 and 184) (odds ratio [OR] 26.7; 95% confidence interval [CI], 5.96 to 239.4;  P <  0.001). This contrasts with Mekong countries, where the CVIET haplotype of  pfcrt  predominates. Among 231 evaluable isolates, only 9 (3.9%) showed any evidence of nonsynonymous gene variants in the propeller domain of  pfk13  The Thr474Ala variant was seen in six individuals, and Cys580Tyr was identified with low confidence in only a single isolate from an asymptomatic individual. Among a subset of 117 symptomatic  P. falciparum -infected individuals randomized to receive either dihydroartemisinin-piperaquine or artemether-lumefantrine, the treatment outcome was not associated with pretreatment genotype. However, submicroscopic persistent parasites at day 28 or day 42 of follow-up were significantly more likely to harbor the  pfmdr1  haplotype NF (codons 86 and 184) than were pretreatment isolates ( P  < 0.001 for both treatment groups). Current ACT regimens appear to be effective in Sumatera, but evidence of persistent submicroscopic infection in some patients suggests further detailed studies of drug susceptibility should be undertaken.",2020,"Among 231 evaluable isolates, only nine (3.9%) showed any evidence of non-synonymous gene variants in the propeller domain of  pfk13  ","['Plasmodium faciparum  carrying  pf k13 polymorphisms harbour the SVMNT allele of  pfcrt  in north-western Indonesia', '3,731 residents of three Regencies']","['dihydroartemisinin-piperaquine or artemether-lumefantrine', 'Artemisinin-based combination therapy']",[],"[{'cui': 'C0032148', 'cui_str': 'Plasmodium'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C1673263', 'cui_str': 'KRT13 protein, human'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0936150', 'cui_str': 'artemether and lumefantrine'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]",[],,0.0499095,"Among 231 evaluable isolates, only nine (3.9%) showed any evidence of non-synonymous gene variants in the propeller domain of  pfk13  ","[{'ForeName': 'Inke N D', 'Initials': 'IND', 'LastName': 'Lubis', 'Affiliation': 'Department of Infection Biology, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Hendri', 'Initials': 'H', 'LastName': 'Wijaya', 'Affiliation': 'Department of Paediatrics, University of Sumatera Utara, Medan, Indonesia.'}, {'ForeName': 'Munar', 'Initials': 'M', 'LastName': 'Lubis', 'Affiliation': 'Department of Paediatrics, University of Sumatera Utara, Medan, Indonesia.'}, {'ForeName': 'Chairuddin P', 'Initials': 'CP', 'LastName': 'Lubis', 'Affiliation': 'Department of Paediatrics, University of Sumatera Utara, Medan, Indonesia.'}, {'ForeName': 'Khalid B', 'Initials': 'KB', 'LastName': 'Beshir', 'Affiliation': 'Department of Infection Biology, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Sutherland', 'Affiliation': 'Department of Infection Biology, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom colin.sutherland@lshtm.ac.uk.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.02539-19']
78,32386747,Effect of immune regulatory pathways after immunization with GMZ2 malaria vaccine candidate in healthy lifelong malaria-exposed adults.,"BACKGROUND


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


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


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


Regulatory immune responses are induced following immunization. Stronger sHLA-G and Treg immune responses may suppress vaccine induced immune responses, and the magnitude of the sHLA-G response increased the risk of Plasmodium falciparum infection after CHMI. These findings could have implications for the design and testing of malaria vaccine candidates in semi-immune individuals.",2020,"The sHLA-G level on D84 was associated with a decrease of the anti-GMZ2 IgG concentration, whereas Treg frequencies on D0 or on D84, and Breg frequency on D84 were associated with lower plasmablast frequencies.","['Fifty Gabonese adults with lifelong exposure to Plasmodium spp', 'healthy lifelong malaria-exposed adults']","['30\xa0µg or 100\xa0µg GMZ2-CAF01, or 100\xa0µg GMZ2-alum, or control vaccine (rabies vaccine', 'GMZ2 malaria vaccine candidate']","['Vaccine efficacy', 'sHLA-G levels and anti-GMZ2 IgG concentrations', 'anti-GMZ2 IgG concentration', 'Only plasma and peripheral blood mononuclear cells', 'sHLA-G concentration', 'risk of P. falciparum infection']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4274169', 'cui_str': 'Lifelong'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0032148', 'cui_str': 'Plasmodium'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0051522', 'cui_str': 'aluminum sulfate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0034496', 'cui_str': 'Rabies vaccine'}, {'cui': 'C0206255', 'cui_str': 'Malarial Vaccines'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",35.0,0.0706217,"The sHLA-G level on D84 was associated with a decrease of the anti-GMZ2 IgG concentration, whereas Treg frequencies on D0 or on D84, and Breg frequency on D84 were associated with lower plasmablast frequencies.","[{'ForeName': 'Odilon', 'Initials': 'O', 'LastName': 'Nouatin', 'Affiliation': ""Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany; Département de Biochimie et de Biologie Cellulaire, Faculté des Sciences et Techniques, Université d'Abomey-Calavi, Cotonou, Benin. Electronic address: paterneodilon@gmail.com.""}, {'ForeName': 'Ulysse', 'Initials': 'U', 'LastName': 'Ateba Ngoa', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon. Electronic address: ulyssus7000@gmail.com.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Ibáñez', 'Affiliation': 'Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany.'}, {'ForeName': 'Jean Claude', 'Initials': 'JC', 'LastName': 'Dejon-Agobe', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Mordmüller', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany. Electronic address: benjamin.mordmueller@uni-tuebingen.de.'}, {'ForeName': 'Jean Ronald', 'Initials': 'JR', 'LastName': 'Edoa', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany. Electronic address: j.ronaldedoa@cermel.org.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Mougeni', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Brückner', 'Affiliation': 'Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany. Electronic address: sinab@gmx.net.'}, {'ForeName': 'Aurore', 'Initials': 'A', 'LastName': 'Bouyoukou Hounkpatin', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Esen', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany. Electronic address: meral.esen@uni-tuebingen.de.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Theisen', 'Affiliation': 'Department for Congenital Disorders, Statens Serum Institut, Copenhagen, Denmark and Centre for Medical Parasitology at Department of International Health, Immunology and Microbiology, University of Copenhagen, and Department of Infectious Diseases, Copenhagen University Hospital, Rigshospitalet, Denmark. Electronic address: mth@ssi.dk.'}, {'ForeName': 'Kabirou', 'Initials': 'K', 'LastName': 'Moutairou', 'Affiliation': ""Département de Biochimie et de Biologie Cellulaire, Faculté des Sciences et Techniques, Université d'Abomey-Calavi, Cotonou, Benin. Electronic address: kamoutairo@yahoo.fr.""}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Hoffman', 'Affiliation': 'Sanaria Inc, Rockville, MD 20850, USA. Electronic address: slhoffman@sanaria.com.'}, {'ForeName': 'Saadou', 'Initials': 'S', 'LastName': 'Issifou', 'Affiliation': 'Fondation pour la Recherche Scientifique, 72 BP45 Cotonou, Benin. Electronic address: isaadou2002@yahoo.fr.'}, {'ForeName': 'Adrian J F', 'Initials': 'AJF', 'LastName': 'Luty', 'Affiliation': ""Centre d'Etude et de Recherche sur le Paludisme Associé à la Grossesse et à l'Enfance, Faculté des Sciences de la Santé, Université d'Abomey-Calavi, Cotonou, MERIT UMR D216, Benin; Université de Paris, MERIT, IRD, Paris, France. Electronic address: adrian.luty@ird.fr.""}, {'ForeName': 'Marguerite M', 'Initials': 'MM', 'LastName': 'Loembe', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany. Electronic address: mmassingaloembe@cermel.org.'}, {'ForeName': 'Selidji Todagbé', 'Initials': 'ST', 'LastName': 'Agnandji', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany. Electronic address: agnandjis@cermel.org.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lell', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Department of Medicine I, Division of Infectious Diseases and Tropical Medicine, Medical University of Vienna, Vienna, Austria. Electronic address: bertrand.lell@cermel.org.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Kremsner', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany. Electronic address: peter.kremsner@uni-tuebingen.de.'}, {'ForeName': 'Ayôla Akim', 'Initials': 'AA', 'LastName': 'Adegnika', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany; Leiden University Medical Centre (LUMC), 2333 ZA Leiden, the Netherlands. Electronic address: aadegnika@cermel.org.'}]",Vaccine,['10.1016/j.vaccine.2020.04.046']
79,32402264,Integrated Cognitive-Behavioral Therapy for Social Anxiety and HIV/STI Prevention for Gay and Bisexual Men: A Pilot Intervention Trial.,"Given the alarmingly high HIV and sexually transmitted infection (STI) incidence among gay and bisexual men (GBM) worldwide, there is a critical need for HIV prevention interventions specifically for GBM. Social anxiety, or anxiety about being evaluated in interpersonal situations, is a risk factor for condomless anal sex (CAS) among GBM (e.g., Hart & Heimberg, 2005; Hart, James, Purcell, & Farber, 2008). Social anxiety may also increase substance use in sexual situations, which is another risk factor for HIV/STIs in this risk group (Semple, Strathdee, Zians, McQuaid, & Patterson, 2011). The goal of the Sexual Confidence Study was to provide initial evidence of efficacy for a 10-session integrated cognitive-behavioral therapy for social anxiety, substance use management in sexual situations, and HIV sexual risk reduction for HIV-negative GBM. Diagnostic and self-report assessments were completed at baseline, posttreatment, 3-month follow-up, and 6-month follow-up. In this open trial design, we observed a 50% reduction in engagement in HIV/STI sexual risk behavior at 6-month follow-up. We also observed large uncontrolled treatment effect sizes for reductions in social anxiety disorder and problematic alcohol use. These preliminary findings suggest that the present treatment may offer an efficient way of concurrently reducing social anxiety, problematic alcohol use, and the risk of contracting HIV and STIs via CAS with serodiscordant partners among HIV-negative GBM.",2020,We also observed large uncontrolled treatment effect sizes for reductions in social anxiety disorder and problematic alcohol use.,"['Gay and Bisexual Men', 'gay and bisexual men (GBM']",['Integrated Cognitive-Behavioral Therapy'],"['HIV/STI sexual risk behavior', 'Social anxiety, or anxiety', 'Social anxiety']","[{'cui': 'C0019898', 'cui_str': 'Queers'}, {'cui': 'C0005639', 'cui_str': 'Bisexuality'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.01273,We also observed large uncontrolled treatment effect sizes for reductions in social anxiety disorder and problematic alcohol use.,"[{'ForeName': 'Trevor A', 'Initials': 'TA', 'LastName': 'Hart', 'Affiliation': 'Ryerson University and University of Toronto. Electronic address: trevor.hart@ryerson.ca.'}, {'ForeName': 'Syed W', 'Initials': 'SW', 'LastName': 'Noor', 'Affiliation': 'Ryerson University.'}, {'ForeName': 'Julia R G', 'Initials': 'JRG', 'LastName': 'Vernon', 'Affiliation': 'Ryerson University.'}, {'ForeName': 'Martin M', 'Initials': 'MM', 'LastName': 'Antony', 'Affiliation': 'Ryerson University.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Gardner', 'Affiliation': 'Baycrest Health Sciences and University of Toronto.'}, {'ForeName': 'Conall', 'Initials': 'C', 'LastName': ""O'Cleirigh"", 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School and Fenway Health, Boston.'}]",Behavior therapy,['10.1016/j.beth.2019.09.001']
80,32394723,"Effects of Depot Medroxyprogesterone Acetate, Copper Intrauterine Devices, and Levonorgestrel Implants on Early HIV Disease Progression.","Limited data exist on the effects of contraceptives on HIV disease progression. We studied the association between intramuscular injectable depot medroxyprogesterone acetate (DMPA-IM), the copper intrauterine device (IUD), and the levonorgestrel (LNG) implant on markers of HIV disease progression at the time of HIV detection and 3 months postdetection and time from detection to CD4 count <350 cells/mm 3 . Among women initiating antiretroviral therapy (ART), we studied the effect of contraceptive group on time from ART initiation to viral load (VL) <40 copies/mL. We included women 16-35 years randomized to DMPA-IM, copper IUD, or LNG implant with incident HIV infection during the Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial ( n  = 382). We analyzed HIV VL and CD4 cell count according to participants' randomized method and also conducted a ""continuous use"" analysis that excluded follow-up time after method discontinuation. We used adjusted linear models to compare mean VL and CD4 cell levels by contraceptive group up to the time of ART initiation. We compared time from HIV detection to CD4 count <350 cells/mm 3  and, following ART initiation, time to viral suppression (VL <40 copies/mL) using Cox proportional hazards models. At HIV detection, women allocated to DMPA-IM had lower VL relative to copper IUD (-0.28 log 10  copies/mL; 95% confidence interval [CI]: -0.55 to -0.01) and LNG implant (-0.27, CI: -0.55 to 0.02) and higher mean CD4 than copper IUD users by 66 cells/mm 3  (CI: 11-121). In continuous use analyses women allocated to DMPA-IM progressed to CD4 < 350 cells/mm 3  slower than copper IUD users (hazard ratio [HR] = 0.6, CI: 0.3-1.1), whereas copper IUD users progressed faster than LNG implant users (HR = 1.8, CI: 1.0-3.3). Time to viral suppression was faster for DMPA-IM than copper IUD (HR = 1.5, CI: 1.0-2.3) and LNG implant 1.4 (CI: 0.9-2.2) users. We found no evidence of more rapid early HIV disease progression among women using DMPA-IM than among women using copper IUD or LNG implant. Our finding of more rapid progression among copper IUD compared with DMPA-IM users should be interpreted cautiously.",2020,"Women using DMPA-IM (HR= 0.6, CI: 0.3, 1.1) and LNG implant (HR = 0.6, CI: 0.3, 1.0) progressed to CD4 <350 slower than copper IUD users and time to viral suppression was faster for DMPA-IM than copper IUD (HR=1.5 (CI: 1.0, 2.3) and LNG implant 1.4 (CI: 0.9-2.2) users in continuous use analysis.
","['women using DMPA-IM', 'women 16-35 years randomized to']","['DMPA-IM, copper IUD, or levonorgestrel implant', 'DMPA-IM, the copper IUD and levonorgestrel (LNG) implant', 'depot medroxyprogesterone acetate, copper intrauterine devices, and levonorgestrel implants']","['mean viral load and CD4 cell levels', 'time to viral suppression', 'VL relative to copper IUD', 'HIV viral load and CD4 cell count', 'early HIV disease progression', 'time to CD4 count <350 cells/mm3 and viral suppression']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0067376', 'cui_str': 'N,N-dimethyl-4-anisidine'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0067376', 'cui_str': 'N,N-dimethyl-4-anisidine'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0015927', 'cui_str': 'Fetal death'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C0021901', 'cui_str': 'Copper Intrauterine Devices'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0039215', 'cui_str': 'T lymphocyte positive for CD4 antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0015927', 'cui_str': 'Fetal death'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1141957', 'cui_str': 'HIV disease progression'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439243', 'cui_str': 'uL'}]",382.0,0.424447,"Women using DMPA-IM (HR= 0.6, CI: 0.3, 1.1) and LNG implant (HR = 0.6, CI: 0.3, 1.0) progressed to CD4 <350 slower than copper IUD users and time to viral suppression was faster for DMPA-IM than copper IUD (HR=1.5 (CI: 1.0, 2.3) and LNG implant 1.4 (CI: 0.9-2.2) users in continuous use analysis.
","[{'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Morrison', 'Affiliation': 'FHI 360, Durham, North Carolina, USA.'}, {'ForeName': 'G Justus', 'Initials': 'GJ', 'LastName': 'Hofmeyr', 'Affiliation': 'Effective Care Research Unit, Department of Obstetrics and Gynaecology, University of Witwatersrand/Fort Hare/Walter Sisulu, East London, South Africa.'}, {'ForeName': 'Katherine K', 'Initials': 'KK', 'LastName': 'Thomas', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Rees', 'Affiliation': 'Wits Reproductive Health and HIV Institute (Wits RHI), University of Witswatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Neena', 'Initials': 'N', 'LastName': 'Philip', 'Affiliation': 'Mailman School of Public Health, ICAP at Columbia University, New York, USA.'}, {'ForeName': 'Thesla', 'Initials': 'T', 'LastName': 'Palanee-Phillips', 'Affiliation': 'Wits Reproductive Health and HIV Institute (Wits RHI), University of Witswatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Nanda', 'Affiliation': 'FHI 360, Durham, North Carolina, USA.'}, {'ForeName': 'Gonasagrie', 'Initials': 'G', 'LastName': 'Nair', 'Affiliation': 'Emavundleni Research Center, Capetown, South Africa.'}, {'ForeName': 'Maricianah', 'Initials': 'M', 'LastName': 'Onono', 'Affiliation': 'KEMRI-RCTP Study Center, Kisumu, Kenya.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Mastro', 'Affiliation': 'FHI 360, Durham, North Carolina, USA.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Lind', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Heffron', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Vinodh', 'Initials': 'V', 'LastName': 'Edward', 'Affiliation': 'The Aurum Institute, Johannesburg, South Africa.'}, {'ForeName': 'Jen', 'Initials': 'J', 'LastName': 'Deese', 'Affiliation': 'FHI 360, Durham, North Carolina, USA.'}, {'ForeName': 'Mags', 'Initials': 'M', 'LastName': 'Beksinska', 'Affiliation': 'MatCH Research Unit (MRU), Faculty of Health Sciences, Department of Obstetrics and Gynecology, University of the Witwatersrand, Durban, South Africa.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Beesham', 'Affiliation': 'MatCH Research Unit (MRU), Faculty of Health Sciences, Department of Obstetrics and Gynecology, University of the Witwatersrand, Durban, South Africa.'}, {'ForeName': 'Jeffrey S A', 'Initials': 'JSA', 'LastName': 'Stringer', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Khatija', 'Initials': 'K', 'LastName': 'Ahmed', 'Affiliation': 'Setshaba Research Center, Soshanguve, South Africa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AIDS research and human retroviruses,['10.1089/AID.2020.0015']
81,32396179,Effect of Surgery vs Functional Bracing on Functional Outcome Among Patients With Closed Displaced Humeral Shaft Fractures: The FISH Randomized Clinical Trial.,"Importance


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


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


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


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


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


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


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


ClinicalTrials.gov Identifier: NCT01719887.",2020,"The primary outcome was Disabilities of Arm, Shoulder and Hand","['closed humeral shaft fractures', 'patients with closed humeral shaft fracture, internal fixation surgery', ' 38 women [46%]; 44 men [54%]), 78 (95%) completed the trial', 'Patients were excluded if they had cognitive disabilities preventing them from following the protocol or had multimorbidity or multiple trauma', 'Patients', '2 university hospital trauma centers in Finland, enrollment between November 2012 and January 2018 with a final follow-up of January 2019', '82 adult patients with closed, unilateral, displaced humeral shaft fracture met criteria for inclusion', 'With Closed Displaced Humeral Shaft Fractures', '82 patients who were randomized (mean age, 48.9 years']","['surgical treatment with open reduction and internal plate fixation to nonsurgical treatment with functional bracing', 'Surgery vs Functional Bracing', 'surgical treatment with open reduction and internal plate fixation (n\u2009=\u200938) or to nonsurgical treatment with functional bracing (n\u2009=\u200944']","['mean DASH score', 'Disabilities of Arm, Shoulder and Hand', 'DASH) score', 'functional outcomes', 'fracture nonunion']","[{'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0588210', 'cui_str': 'Bone structure of shaft of humerus'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0026771', 'cui_str': 'Multiple injuries'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1828220', 'cui_str': 'Application of brace'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0016665', 'cui_str': 'Fracture, ununited'}]",82.0,0.141729,"The primary outcome was Disabilities of Arm, Shoulder and Hand","[{'ForeName': 'Lasse', 'Initials': 'L', 'LastName': 'Rämö', 'Affiliation': 'Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Bakir O', 'Initials': 'BO', 'LastName': 'Sumrein', 'Affiliation': 'Orthopedics and Traumatology, Tampere University Hospital, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Vesa', 'Initials': 'V', 'LastName': 'Lepola', 'Affiliation': 'Orthopedics and Traumatology, Tampere University Hospital, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Tuomas', 'Initials': 'T', 'LastName': 'Lähdeoja', 'Affiliation': 'Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Ranstam', 'Affiliation': 'Mdas AB, Ystad, Sweden.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Paavola', 'Affiliation': 'Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Teppo', 'Initials': 'T', 'LastName': 'Järvinen', 'Affiliation': 'Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Simo', 'Initials': 'S', 'LastName': 'Taimela', 'Affiliation': 'Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.3182']
82,32398580,Transverse vs. parasagittal in-plane approaches in ultrasound-guided paravertebral block using a microconvex probe: A randomised controlled trial.,"BACKGROUND


Several approaches have been proposed for ultrasound-guided thoracic paravertebral block, but the best approach remains unclear.
OBJECTIVE


We compared two ultrasound-guided in-plane approaches using a microconvex probe, transverse and parasagittal. We assessed whether either approach would facilitate successful catheter placement in the paravertebral space.
DESIGN


Randomised controlled trial.
SETTING


University hospital, July 2015 to March 2016.
PATIENTS


Sixty patients scheduled to undergo thoracotomy were randomly allocated into two groups.
INTERVENTIONS


A microconvex probe was placed transversely between adjacent ribs (transverse) or sagittally between adjacent transverse processes (parasagittal). When the Tuohy needle reached the paravertebral space, a catheter was inserted to a depth of 4 cm. Then, 0.5-ml radiocontrast was injected through the catheter under fluoroscopy.
MAIN OUTCOME MEASURES


The primary outcome was successful catheter placement in the paravertebral space; secondary outcomes were 0 to 100 mm visual analogue scale pain score and morphine consumption in the first 24 h.
RESULTS


All patients received the allocated paravertebral block. Correct catheter placement occurred in 23 (77%) and 24 patients (80%) using the transverse (n=30) and parasagittal approaches (n=30), respectively (P = 1.00). Five patients were excluded due to changes in surgical procedure. Postoperative pain, represented by median [IQR] visual analogue scale score, was 19.5 [12 to 25] at rest and 55 [44 to 77] on movement with the transverse approach (n=28) vs. 22 [12 to 33.5] at rest and 59 [41.5 to 75] on movement with the parasagittal approach (n=27) (P = 0.57 at rest, P = 0.76 on movement). Median morphine consumption was 11.5 [5 to 21] and 11 [5 to 18] mg in the transverse and parasagittal approaches, respectively (P = 0.99).
CONCLUSION


There were no clinically significant differences between approaches for continuous ultrasound-guided thoracic paravertebral block using a microconvex probe, and both approaches achieved a high rate of correct catheter placement.
TRIAL REGISTRATION


UMIN Clinical Trials Registry identifier: UMIN000015988.",2020,"There were no clinically significant differences between approaches for continuous ultrasound-guided thoracic paravertebral block using a microconvex probe, and both approaches achieved a high rate of correct catheter placement.
","['University hospital, July 2015 to March 2016', 'Sixty patients scheduled to undergo thoracotomy']",[],"['Median morphine consumption', 'successful catheter placement in the paravertebral space; secondary outcomes were 0 to 100\u200amm visual analogue scale pain score and morphine consumption', 'Correct catheter placement', 'Postoperative pain', 'median [IQR] visual analogue scale score']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0883301', 'cui_str': 'Catheter placement'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",5.0,0.212423,"There were no clinically significant differences between approaches for continuous ultrasound-guided thoracic paravertebral block using a microconvex probe, and both approaches achieved a high rate of correct catheter placement.
","[{'ForeName': 'Tasuku', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Department of Anaesthesiology, Nagoya University Graduate School of Medicine (TF, KN), Department of Surgical Center (YS) and Department of Anaesthesiology, Nagoya University Hospital, Nagoya, Japan (SS).'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Shibata', 'Affiliation': ''}, {'ForeName': 'Sonoe', 'Initials': 'S', 'LastName': 'Shinya', 'Affiliation': ''}, {'ForeName': 'Kimitoshi', 'Initials': 'K', 'LastName': 'Nishiwaki', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001223']
83,32398581,"Prophylactic norepinephrine infusion or leg wrapping for postspinal hypotension in elective caesarean delivery: A randomised, double-blind, placebo-controlled trial.","BACKGROUND


Because of its alpha and beta agonist properties, norepinephrine infusion is currently being studied for the prevention of spinal hypotension during caesarean delivery. Vasopressor infusions are not always possible if there is an unavailability of infusion pumps. Leg wrapping with crepe bandage is an effective technique for prevention of postspinal hypotension and could be useful in resource-poor settings.
OBJECTIVE


The aim of this study was to compare the incidence of hypotension with norepinephrine infusion or leg wrapping with a control group in women undergoing caesarean delivery with spinal anaesthesia.
DESIGN


Randomised, double-blind, controlled trial.
SETTING


Single centre, tertiary level institute, India.Study period 3 April 2018 to 31 March 2019.
PATIENTS


One hundred and forty-four women aged 19 to 40 years with a singleton pregnancy.
INTERVENTION


In group Leg Wrapping, crepe bandage was applied tightly from metatarsus to groin. Group Norepinephrine and the control group received sham leg wrapping. In group Norepinephrine, the women received a norepinephrine infusion according to their body weight, while group Leg Wrapping and the control group received a 0.9% normal saline infusion at a similar rate. All three groups received a 500 ml co-load of Ringer's solution over 15 min. Noninvasive SBP was monitored every 2 min until delivery, and every 5 min thereafter. Any hypotensive event (SBP < 20% of baseline) was treated with an intravenous bolus of norepinephrine (7.5 μg).
MAIN OUTCOME MEASURES


The primary outcome was the incidence of hypotension. The secondary outcomes were performance error measurements, and the incidences of hypertension, bradycardia, norepinephrine rescue bolus and neonatal outcomes.
RESULTS


The incidences of hypotension were significantly lower in the norepinephrine infusion group and the leg wrapping groups than the control group (P values 0.021 for both). Performance error calculations showed that SBP was maintained closer to baseline with the norepinephrine infusion.
CONCLUSION


Norepinephrine infusion and leg wrapping can both reduce the incidence of postspinal hypotension during elective caesarean delivery compared with saline infusion alone.
TRIAL REGISTRATION


Clinical trial number and registry URL: CTRI/2018/04/012917 registered at Clinical Trial Registry of India http://www.ctri.nic.in/Clinicaltrials/login.php.",2020,The incidences of hypotension were significantly lower in the norepinephrine infusion group and the leg wrapping groups than the control group (P values 0.021 for both).,"['Study period 3 April 2018 to 31 March 2019', 'postspinal hypotension in elective caesarean delivery', 'Single centre, tertiary level institute, India', 'One hundred and forty-four women aged 19 to 40 years with a singleton pregnancy', 'women undergoing caesarean delivery with spinal anaesthesia']","['saline infusion alone', 'norepinephrine infusion', 'Prophylactic Norepinephrine infusion and Leg Wrapping', 'Norepinephrine', ""500\u200aml co-load of Ringer's solution"", 'Vasopressor infusions', 'Leg wrapping with crepe bandage', 'norepinephrine', 'sham leg wrapping', 'normal saline infusion', 'norepinephrine infusion or leg wrapping with a control group', 'placebo']","['postspinal hypotension', 'Noninvasive SBP', 'incidence of hypotension', 'performance error measurements, and the incidences of hypertension, bradycardia, norepinephrine rescue bolus and neonatal outcomes', 'incidences of hypotension']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0445414', 'cui_str': 'Wrapping'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0073386', 'cui_str': 'Ringers Solution'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0460462', 'cui_str': 'Cotton crepe bandage'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",144.0,0.410984,The incidences of hypotension were significantly lower in the norepinephrine infusion group and the leg wrapping groups than the control group (P values 0.021 for both).,"[{'ForeName': 'Monisha', 'Initials': 'M', 'LastName': 'Sundararajan', 'Affiliation': 'From the Department of Anaesthesiology, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth (Deemed University), Puducherry, India (MS, CR, RP, RM).'}, {'ForeName': 'Charulatha', 'Initials': 'C', 'LastName': 'Ravindran', 'Affiliation': ''}, {'ForeName': 'Rani', 'Initials': 'R', 'LastName': 'Ponnusamy', 'Affiliation': ''}, {'ForeName': 'Ravishankar', 'Initials': 'R', 'LastName': 'Murugesan', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001231']
84,32289353,Risk of contamination when planning psychological therapy trials can be assessed using a simple framework.,"OBJECTIVES


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


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


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


The risk of contamination framework we piloted in this study could be a helpful tool for researchers aiming to identify and manage risk of contamination in their trial protocol development. We found that the risk of contamination was relatively low in the psychological therapy trials we sampled for this study, as measured by our framework, and could usually be mitigated through reasonable adjustments to the study design.",2020,"Overall, we found that the risk of contamination across all three sources was low for most studies (86 of 100 trial protocols; 86%).","['contamination: 1) participants in the control arm, 2) participants in the intervention arm, 3) therapists in the intervention arm']",[],['risk of contamination'],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}]",10.0,0.109149,"Overall, we found that the risk of contamination across all three sources was low for most studies (86 of 100 trial protocols; 86%).","[{'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Jacobsen', 'Affiliation': ""Department of Psychology, University of Bath, Bath BA2 7AY; King's College London, Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), De Crespigny Park, London SE5 8AF. Electronic address: p.c.jacobsen@bath.ac.uk.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wood', 'Affiliation': 'Acute and Rehabilitation Directorate Psychology Team, North East London NHS Foundation Trust, Goodmayes Hospital, Barley Lane, Ilford IG3 8XJ; Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road W1T 7DN.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2020.04.005']
85,32394601,"Re: Antenatal magnesium sulphate for the prevention of cerebral palsy in infants born preterm: a double-blind, randomised, placebo-controlled, multi-centre trial: At which gestational ages should magnesium sulphate be given to women at risk of preterm birth?",,2020,,['infants born preterm'],"['magnesium sulphate', 'placebo']",['cerebral palsy'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]",,0.793615,,"[{'ForeName': 'Mads Langager', 'Initials': 'ML', 'LastName': 'Larsen', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Krebs', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Hospital Amager Hvidovre, Copenhagen, Denmark.'}, {'ForeName': 'Gija', 'Initials': 'G', 'LastName': 'Rackauskaite', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, University Hospital Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Christina Engel', 'Initials': 'CE', 'LastName': 'Hoei-Hansen', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Gorm', 'Initials': 'G', 'LastName': 'Greisen', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, University Hospital Rigshospitalet, Copenhagen, Denmark.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16268']
86,32395901,A randomised controlled trial comparing deep neuromuscular blockade reversed with sugammadex with moderate neuromuscular block reversed with neostigmine.,"Deep neuromuscular block aims to improve operative conditions during laparoscopic surgery with a lower intra-abdominal pressure. Studies are conflicting on whether meaningful improvements in quality of recovery occur beyond emergence, and whether lower intra-abdominal pressure is achieved. In this pragmatic randomised trial with 1:1 allocation, adults undergoing elective laparoscopic surgery were allocated to moderate neuromuscular block reversed with neostigmine, or deep neuromuscular block reversed with sugammadex. Allocation was revealed to the anaesthetist only. Primary outcome was cognitive recovery of the Postoperative Quality of Recovery Scale, 7 days after surgery. Secondary outcomes included recovery in other domains of the Postoperative Quality of Recovery Scale at 15 min and 40 min; days 1, 3, 7, 14; and 1 and 3 months after surgery. Chi-square test was used for the primary outcome, and generalised linear mixed model for recovery over time between groups. Of 350 participants randomised, 140 (deep) and 144 (moderate) were analysed for the primary outcome. There was no difference in the Postoperative Quality of Recovery Scale cognitive domain at day 7 (deep 92.9% vs. moderate 91.8%, OR 1.164; 95%CI 0.486-2.788, p = 0.826), or at any other time-point. No significant difference was observed for physiological, emotive, activities of daily living, nociception, or overall recovery. Length of stay in the recovery area (mean (SD) deep 108 (58) vs. moderate 109 (57) min, p = 0.78) and hospital (1.8 (1.9) vs. 2.6 (3.5) days, p = 0.019) was not different. Intra-abdominal pressure and surgical operating conditions were not different between groups. Deep neuromuscular block did not improve quality of recovery compared with moderate neuromuscular block in operative laparoscopic surgery over a 1-h duration.",2020,"No significant difference was observed for physiological, emotive, activities of daily living, nociception, or overall recovery.","['adults undergoing elective laparoscopic surgery', '350 participants randomised, 140 (deep) and 144 (moderate']","['neostigmine, or deep neuromuscular block reversed with sugammadex', 'neostigmine', 'laparoscopic surgery']","['Length of stay', 'Postoperative Quality of Recovery Scale cognitive domain', 'physiological, emotive, activities of daily living, nociception, or overall recovery', 'recovery in other domains of the Postoperative Quality of Recovery Scale', 'Intra-abdominal pressure and surgical operating conditions', 'cognitive recovery of the Postoperative Quality of Recovery Scale', 'quality of recovery']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0235062', 'cui_str': 'Induction of neuromuscular blockade'}, {'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",350.0,0.636283,"No significant difference was observed for physiological, emotive, activities of daily living, nociception, or overall recovery.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Boggett', 'Affiliation': 'Department of Surgery, University of Melbourne, Vic., Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Chahal', 'Affiliation': 'Department of Anaesthesia, Peri-operative and Pain Medicine, Peter MacCallum Cancer Centre, Melbourne, Vic., Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Griffiths', 'Affiliation': ""Department of Anaesthesia, Royal Women's Hospital, Melbourne, Vic., Australia.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Anaesthesia, Peri-operative and Pain Medicine, Peter MacCallum Cancer Centre, Melbourne, Vic., Australia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Anaesthesia, Peri-operative and Pain Medicine, Peter MacCallum Cancer Centre, Melbourne, Vic., Australia.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Williams', 'Affiliation': 'Department of Surgery, University of Melbourne, Vic., Australia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Riedel', 'Affiliation': 'Department of Anaesthesia, Peri-operative and Pain Medicine, Peter MacCallum Cancer Centre, Melbourne, Vic., Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bowyer', 'Affiliation': 'Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Melbourne, Vic., Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Royse', 'Affiliation': 'Department of Surgery, University of Melbourne, Vic., Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Royse', 'Affiliation': 'Department of Surgery, University of Melbourne, Vic., Australia.'}]",Anaesthesia,['10.1111/anae.15094']
87,32402160,Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma.,"BACKGROUND


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


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


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


In patients with unresectable hepatocellular carcinoma, atezolizumab combined with bevacizumab resulted in better overall and progression-free survival outcomes than sorafenib. (Funded by F. Hoffmann-La Roche/Genentech; ClinicalTrials.gov number, NCT03434379.).",2020,"Overall survival at 12 months was 67.2% (95% CI, 61.3 to 73.1) with atezolizumab-bevacizumab and 54.6% (95% CI, 45.2 to 64.0) with sorafenib.","['patients with unresectable hepatocellular carcinoma who had not previously received systemic treatment', 'group and 165 patients in the sorafenib group', 'Unresectable Hepatocellular Carcinoma', '336 patients in the', 'patients with unresectable hepatocellular carcinoma']","['sorafenib', 'atezolizumab and bevacizumab', 'Atezolizumab plus Bevacizumab', 'atezolizumab-bevacizumab', 'atezolizumab plus bevacizumab or sorafenib', 'bevacizumab']","['overall and progression-free survival outcomes', 'Median progression-free survival', 'Grade 3 or 4 hypertension', 'Grade 3 or 4 adverse events', 'Overall survival', 'antitumor activity and safety', 'grade toxic effects', 'overall survival and progression-free survival', 'hazard ratio for death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.465943,"Overall survival at 12 months was 67.2% (95% CI, 61.3 to 73.1) with atezolizumab-bevacizumab and 54.6% (95% CI, 45.2 to 64.0) with sorafenib.","[{'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Galle', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Ducreux', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Tae-You', 'Initials': 'TY', 'LastName': 'Kim', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Valeriy', 'Initials': 'V', 'LastName': 'Breder', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Merle', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Ahmed O', 'Initials': 'AO', 'LastName': 'Kaseb', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Daneng', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Verret', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Derek-Zhen', 'Initials': 'DZ', 'LastName': 'Xu', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Sairy', 'Initials': 'S', 'LastName': 'Hernandez', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Sohail', 'Initials': 'S', 'LastName': 'Mulla', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Yulei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Ho Yeong', 'Initials': 'HY', 'LastName': 'Lim', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Andrew X', 'Initials': 'AX', 'LastName': 'Zhu', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Ann-Lii', 'Initials': 'AL', 'LastName': 'Cheng', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915745']
88,32402261,The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) Adapted as a School-Based Anxiety and Depression Prevention Program: An Initial Cluster Randomized Wait-List-Controlled Trial.,"Anxiety and depression are common debilitating conditions that show high comorbidity rates in adolescence. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A; Ehrenreich-May et al., 2018) is one of the few existing resources aimed at applying transdiagnostic treatment principles across the core dysfunctions implicated in the development of both anxiety and depression using a single protocol. This is the first known controlled study to examine the efficacy of the UP-A adapted as a nine-session universal preventive intervention program delivered in a school setting. A total of 151 students (mean age: 15.05) participated in this randomized wait-list-controlled trial conducted in Madrid, Spain. An unexpected decline in anxiety and depression levels from pre- to posttreatment and follow-up was found in both groups (p = .009, d = -0.22), and overall differences between conditions did not reach significance. Exploratory analyses of baseline emotional symptom severity as a potential predictor trended toward a significantly greater decrease in symptoms of depression for those with greater baseline emotional symptoms in the UP-A group compared to the wait-list-control group. Future trials with larger samples are justified to estimate the effect of the UP-A adapted as a selective prevention program for anxiety and depression.",2020,"An unexpected decline in anxiety and depression levels from pre- to posttreatment and follow-up was found in both groups (p = .009, d = -0.22), and overall differences between conditions did not reach significance.","['Emotional Disorders in Adolescents (UP-A) Adapted as a School-Based Anxiety and Depression Prevention Program', '151 students (mean age: 15.05) participated in this randomized wait-list-controlled trial conducted in Madrid, Spain']",[],"['symptoms of depression', 'anxiety and depression levels']","[{'cui': 'C0233459', 'cui_str': 'Emotional disorder'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}]",151.0,0.0310334,"An unexpected decline in anxiety and depression levels from pre- to posttreatment and follow-up was found in both groups (p = .009, d = -0.22), and overall differences between conditions did not reach significance.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'García-Escalera', 'Affiliation': 'Universidad Nacional de Educación a Distancia.'}, {'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Valiente', 'Affiliation': 'Universidad Nacional de Educación a Distancia. Electronic address: rmvalien@psi.uned.es.'}, {'ForeName': 'Bonifacio', 'Initials': 'B', 'LastName': 'Sandín', 'Affiliation': 'Universidad Nacional de Educación a Distancia.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Ehrenreich-May', 'Affiliation': 'University of Miami.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Prieto', 'Affiliation': 'Universidad Nacional de Educación a Distancia.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Chorot', 'Affiliation': 'Universidad Nacional de Educación a Distancia.'}]",Behavior therapy,['10.1016/j.beth.2019.08.003']
89,32398341,Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE) randomised clinical trial: study protocol.,"INTRODUCTION


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


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


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


The BALANCE (Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness) trial was registered at www.clinicaltrials.gov (registration number: NCT03005145).",2020,"The primary outcome is 90-day survival; we will test whether 7 days is non-inferior to 14 days of treatment, with a non-inferiority margin of 4% absolute mortality.","['patients with blood cultures confirming a pathogenic bacterium after hospital admission', 'hospitalised patients with bloodstream infections', '3626 patients across 60 hospitals and 6 countries', 'patients admitted to hospital']","['antibiotic treatment', 'placebo']","['Antibiotic Length', 'hospital and intensive care unit (ICU) mortality, relapse rates of bacteraemia, hospital and ICU length of stay, mechanical ventilation and vasopressor duration, antibiotic-free days,  C lostridium  difficile  infection, antibiotic allergy and adverse events and colonisation/infection with antibiotic-resistant organisms', '90-day survival', 'non-inferiority margin of 4% absolute mortality', 'Bacteremia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0200949', 'cui_str': 'Blood culture'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0741103', 'cui_str': 'Allergy to antibiotic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",3626.0,0.403099,"The primary outcome is 90-day survival; we will test whether 7 days is non-inferior to 14 days of treatment, with a non-inferiority margin of 4% absolute mortality.","[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Daneman', 'Affiliation': 'Division of Infectious Diseases & Clinical Epidemiology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada Nick.Daneman@sunnybrook.ca.'}, {'ForeName': 'Asgar H', 'Initials': 'AH', 'LastName': 'Rishu', 'Affiliation': 'Institute for Clinical Evaluative Sciences, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Ruxandra L', 'Initials': 'RL', 'LastName': 'Pinto', 'Affiliation': 'Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Yaseen M', 'Initials': 'YM', 'LastName': 'Arabi', 'Affiliation': 'Intensive Care Department, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Cook', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hall', 'Affiliation': 'Departments of Critical Care Medicine and Anesthesiology, Pain Management and Perioperative Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'McGuinness', 'Affiliation': 'Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Muscedere', 'Affiliation': 'Kingston General Hospital, Kingston, Ontario, Canada.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Parke', 'Affiliation': 'The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Reynolds', 'Affiliation': 'Royal Columbian Hospital, New Westminster, British Columbia, Canada.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Rogers', 'Affiliation': 'Centre for Inflammatory Diseases, Monash University School of Clinical Sciences, Melborne, Victoria, Australia.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Shehabi', 'Affiliation': 'Critical Care and Perioperative Medicine, School of Clinical Sciences, Monash University and Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Fowler', 'Affiliation': 'Departments of Medicine and Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-038300']
90,32396966,Kinesiotaping Diminishes Delayed Muscle Soreness but does not Improve Muscular Performance.,"This study aimed at determining the effect of kinesio-taping (KT) on muscle performance and delayed onset muscle soreness (DOMS) after exercise induced muscle damaged. Sixty-six healthy men volunteered to participate (age:18-25 y/o), who performed 200 isokinetic lengthening contractions of the dominant quadriceps. Then subjects were randomized to either control (no treatment), sham (no tape tension), or KT (10% tape tension) groups. Muscle performance was assessed by peak torque and muscular work during maximal isometric and concentric isokinetic contractions. DOMS intensity was assessed using a visual analog scale. Measurements were taken pre-exercise (Pre), 48 h and 96 h post-exercise. Repeated measures ANOVA was used for comparisons within group, and ANCOVA for comparisons among groups. Muscle damage was confirmed in all participants by an increase in CK activity level (p<0.01). Decrease in isometric and isokinetic peak torque was detected at 48 h in the control and sham groups (p<0.01). Muscular work decreased in all groups at 48 h (p<0.01). No differences between groups were detected in muscular performance variables. Increase in DOMS intensity was determined in all groups at 48 h. Comparisons between groups showed lower DOMS intensity in the KT group at 48 h. KT decreased DOMS intensity perception after exercise-induced muscle damage; however, it did not impact muscular performance.",2020,Decrease in isometric and isokinetic peak torque was detected at 48 h in the control and sham groups (p<0.01).,"['Sixty-six healthy men volunteered to participate (age:18-25\u2009y/o), who performed 200 isokinetic lengthening contractions of the dominant quadriceps']","['control (no treatment), sham (no tape tension), or KT', 'kinesio-taping (KT']","['CK activity level', 'muscle performance and delayed onset muscle soreness (DOMS', 'isometric and isokinetic peak torque', 'Muscle performance', 'Muscle damage', 'peak torque and muscular work during maximal isometric and concentric isokinetic contractions', 'DOMS intensity', 'muscular performance variables', 'Muscular work', 'Delayed Muscle Soreness', 'DOMS intensity perception', 'Muscular Performance']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0441592', 'cui_str': 'Surgical lengthening - action'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0233494', 'cui_str': 'Tension'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",66.0,0.0608429,Decrease in isometric and isokinetic peak torque was detected at 48 h in the control and sham groups (p<0.01).,"[{'ForeName': 'Maria Alejandra', 'Initials': 'MA', 'LastName': 'Camacho', 'Affiliation': 'Physical Therapy School, Universidad Industrial de Santander, Bucaramanga, Colombia.'}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Herrera', 'Affiliation': 'Physical Therapy School, Universidad Industrial de Santander, Bucaramanga, Colombia.'}, {'ForeName': 'Jose Angelo', 'Initials': 'JA', 'LastName': 'Barela', 'Affiliation': 'Instituto de Biociências, Universidade Estadual Paulista Julio de Mesquita Filho, Instituto de Biociência Campus de Rio Claro, Rio Claro, Brazil.'}, {'ForeName': 'Diana Carolina', 'Initials': 'DC', 'LastName': 'Delgado-Diaz', 'Affiliation': 'Physical Therapy School, Universidad Industrial de Santander, Bucaramanga, Colombia.'}]",International journal of sports medicine,['10.1055/a-1088-5223']
91,32333883,Effects of 20-year infancy-onset dietary counselling on cardiometabolic risk factors in the Special Turku Coronary Risk Factor Intervention Project (STRIP): 6-year post-intervention follow-up.,"BACKGROUND


Primordial and primary prevention is the cornerstone for cardiometabolic health. In the randomised, controlled Special Turku Coronary Risk Factor Intervention Project (STRIP; n=1116), a 20-year dietary counselling intervention was given to children biannually from infancy, and cardiometabolic health benefits had been observed among the participants in the intervention group. Here, we report on the key results of the first follow-up done 6 years after the end of the intervention, at age 26 years.
METHODS


The randomised controlled STRIP study recruited children at age 5 months from well-baby clinics in Turku, Finland, and randomly assigned them to either an intervention or control group; group allocation was unmasked. The intervention introduced participants to a heart-healthy diet, characterised by low proportional intake of saturated fat and cholesterol, by dietary counselling and nutrition education sessions to parents and children from the age of 7 months to 20 years. Children in the control group received only the basic health education given at Finnish well-baby clinics and school health care. We assessed diet, lifestyle, and cardiometabolic risk factor data, including blood pressure, anthropometry, serum biochemistry (lipids, apolipoproteins, glucose, and insulin), and homoeostatic model assessment of insulin resistance (HOMA-IR) in the participants at age 26 years.
FINDINGS


1116 children were included in the original STRIP study, of whom 551 provided data at the age 26 years follow-up, and data for 507 participants were analysed (243 in the intervention group and 264 in the control group). At follow-up, those who had been in the intervention group had slightly lower mean intake of saturated fat as a proportion of total energy intake than the control group (13·0% [SD 3·3] vs 13·7% [3·6], p=0·049). A higher proportion of participants in the intervention group achieved the targeted monounsaturated and polyunsaturated fat to saturated fat ratio of more than 2:1 than the control group (78 [39%] of 200 vs 70 [30%] of 235; risk ratio [RR] 1·16 [95% CI 1·01-1·33]; p=0·035). A higher proportion of intervention group participants met the ideal total cholesterol concentration of less than 5·17 mmol/L (194 [81%] of 240 vs 187 [72%] of 261; RR 1·45 [1·05-2·01], p=0·024) and optimal LDL cholesterol concentration of less than 3·0 mmol/L (166 [69%] of 240 vs 158 [61%] of 251; RR 1·30 [1·03-1·66], p=0·031). Those who received the intervention had lower glucose (5·00 mmol/L [SD 0·43] vs 5·07 mmol/L [0·46], p=0·040) and HOMA-IR (median 1·44 [IQR 1·09-1·91] vs 1·62 [1·22-2·09], p=0·037) than the participants in the control group.
INTERPRETATION


Previously observed intervention effects during the 20-year counselling were largely maintained into adulthood 6 years after the withdrawal of the intervention. Dietary counselling introduced in infancy thus provided a sustained benefit to diet quality and cardiometabolic risk factor levels.
FUNDING


Academy of Finland, Juho Vainio Foundation, Finnish Foundation for Cardiovascular Research, Finnish Ministry of Education and Culture, Finnish Cultural Foundation, Sigrid Jusélius Foundation, Special Governmental grants for Health Sciences Research (Turku University Hospital), Yrjö Jahnsson Foundation, Finnish Medical Foundation, and Turku University Foundation.",2020,Previously observed intervention effects during the 20-year counselling were largely maintained into adulthood 6 years after the withdrawal of the intervention.,"['1116 children were included in the original STRIP study, of whom 551 provided data at the age 26 years follow-up, and data for 507 participants were analysed (243 in the intervention group and 264 in the control group', 'children at age 5 months from well-baby clinics in Turku, Finland', 'participants at age 26 years']","['20-year infancy-onset dietary counselling', 'heart-healthy diet, characterised by low proportional intake of saturated fat and cholesterol, by dietary counselling and nutrition education sessions', 'basic health education given at Finnish well-baby clinics and school health care', '20-year dietary counselling intervention']","['optimal LDL cholesterol concentration', 'ideal total cholesterol concentration', 'diet, lifestyle, and cardiometabolic risk factor data, including blood pressure, anthropometry, serum biochemistry (lipids, apolipoproteins, glucose, and insulin), and homoeostatic model assessment of insulin resistance (HOMA-IR', 'total energy intake', 'cardiometabolic risk factors', 'targeted monounsaturated and polyunsaturated fat to saturated fat ratio', 'HOMA-IR']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0450381', 'cui_str': '507'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0458075', 'cui_str': 'Well baby'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0418901', 'cui_str': 'Health education given'}, {'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C0458075', 'cui_str': 'Well baby'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0036372', 'cui_str': 'Nursing, School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0003591', 'cui_str': 'Apolipoprotein'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",1116.0,0.0313873,Previously observed intervention effects during the 20-year counselling were largely maintained into adulthood 6 years after the withdrawal of the intervention.,"[{'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Pahkala', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Turku, Finland; Paavo Nurmi Centre, Sports and Exercise Medicine Unit, Department of Health and Physical Activity, University of Turku, Turku, Finland; Centre for Population Health Research, Turku University Hospital, University of Turku, Turku, Finland. Electronic address: katja.pahkala@utu.fi.'}, {'ForeName': 'Tomi T', 'Initials': 'TT', 'LastName': 'Laitinen', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Turku, Finland; Centre for Population Health Research, Turku University Hospital, University of Turku, Turku, Finland.'}, {'ForeName': 'Harri', 'Initials': 'H', 'LastName': 'Niinikoski', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Turku University Hospital, University of Turku, Turku, Finland.'}, {'ForeName': 'Noora', 'Initials': 'N', 'LastName': 'Kartiosuo', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Turku, Finland; Centre for Population Health Research, Turku University Hospital, University of Turku, Turku, Finland.'}, {'ForeName': 'Suvi P', 'Initials': 'SP', 'LastName': 'Rovio', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Turku, Finland; Centre for Population Health Research, Turku University Hospital, University of Turku, Turku, Finland.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Lagström', 'Affiliation': 'Centre for Population Health Research, Turku University Hospital, University of Turku, Turku, Finland; Department of Public Health, Turku University Hospital, University of Turku, Turku, Finland.'}, {'ForeName': 'Britt-Marie', 'Initials': 'BM', 'LastName': 'Loo', 'Affiliation': 'Joint Clinical Biochemistry Laboratory, Turku University Hospital, University of Turku, Turku, Finland.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Salo', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Turku, Finland; Centre for Population Health Research, Turku University Hospital, University of Turku, Turku, Finland.'}, {'ForeName': 'Eero', 'Initials': 'E', 'LastName': 'Jokinen', 'Affiliation': ""Department of Pediatrics, New Children's Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Costan G', 'Initials': 'CG', 'LastName': 'Magnussen', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Turku, Finland; Centre for Population Health Research, Turku University Hospital, University of Turku, Turku, Finland; Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Juonala', 'Affiliation': 'Department of Medicine, Division of Medicine, Turku University Hospital, University of Turku, Turku, Finland.'}, {'ForeName': 'Olli', 'Initials': 'O', 'LastName': 'Simell', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Turku, Finland; Centre for Population Health Research, Turku University Hospital, University of Turku, Turku, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Jula', 'Affiliation': 'Department of Chronic Disease Prevention, National Institute for Health and Welfare, Turku, Finland.'}, {'ForeName': 'Tapani', 'Initials': 'T', 'LastName': 'Rönnemaa', 'Affiliation': 'Department of Medicine, Division of Medicine, Turku University Hospital, University of Turku, Turku, Finland.'}, {'ForeName': 'Jorma', 'Initials': 'J', 'LastName': 'Viikari', 'Affiliation': 'Department of Medicine, Division of Medicine, Turku University Hospital, University of Turku, Turku, Finland.'}, {'ForeName': 'Olli T', 'Initials': 'OT', 'LastName': 'Raitakari', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Turku, Finland; Centre for Population Health Research, Turku University Hospital, University of Turku, Turku, Finland; Department of Clinical Physiology and Nuclear Medicine, Turku University Hospital, University of Turku, Turku, Finland.'}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(20)30059-6']
92,32336008,A randomised Phase II trial of carboplatin and gemcitabine ± vandetanib in first-line treatment of patients with advanced urothelial cell cancer not suitable to receive cisplatin.,"OBJECTIVES


To assess the efficacy and tolerability of the dual epidermal growth factor receptor/vascular endothelial growth factor receptor inhibitor, vandetanib, in combination with carboplatin and gemcitabine in the first-line treatment of patients with advanced transitional cell carcinoma urothelial cancer (UC) who were unsuitable for cisplatin.
PATIENTS AND METHODS


From 2011 to 2014, 82 patients were randomised from 16 hospitals across the UK into the TOUCAN double-blind, placebo-controlled randomised Phase II trial, receiving six 21-day cycles of intravenous carboplatin (target area under the concentration versus time curve 4.5, day 1) and gemcitabine (1000 mg/m 2  days 1 and 8) combined with either oral vandetanib 100 mg or placebo (once daily). Progression-free survival (PFS; primary endpoint), adverse events, tolerability and feasibility of use, objective response rate and overall survival (OS) were evaluated. Intention-to-treat and per-protocol analyses were used to analyse the primary endpoint.
RESULTS


The 82 patients were randomised 1:1 to vandetanib (n = 40) or placebo (n = 42), and 25 patients (30%) completed six cycles of all allocated treatment. Toxicity Grade ≥3 was experienced in 80% (n = 32) and 76% (n = 32) of patients in the vandetanib and placebo arms, respectively. The median PFS was 6.8 and 8.8 months for the vandetanib and placebo arms, respectively (hazard ratio [HR] 1.07, 95% confidence interval [CI] 0.65-1.76; P = 0.71); the median OS was 10.8 vs 13.8 months (HR 1.41, 95% CI 0.79-2.52; P = 0.88); and radiological response rates were 50% and 55%.
CONCLUSION


There is no evidence that vandetanib improves clinical outcome in this setting. Our present data do not support its adoption as the regimen of choice for first-line treatment in patients with UC who were unfit for cisplatin.",2020,Toxicity ≥grade 3 was experienced in 80% (n=32) and 76% (n=32) of patients on vandetanib and placebo arms respectively.,"['UC patients who were unfit for cisplatin', '25 patients (30%) completed 6 cycles of all allocated treatment', 'Eighty-two patients', 'patients with advanced urolthelial cancer (UC) who were unsuitable for cisplatin', 'From 2011 and 2014', 'advanced urothelial cell cancer patients', '82 patients were randomised from 16 hospitals across the UK into the TOUCAN double-blind']","['oral vandetanib 100mg or placebo', 'carboplatin and gemcitabine ', 'dual EGFR/VEGFR inhibitor, vandetanib, in combination with carboplatin and gemcitabine', 'placebo', 'cisplatin', 'vandetanib', 'intravenous carboplatin (AUC 4.5 day 1) and gemcitabine']","['efficacy and tolerability', 'radiological response rates', 'Progression-free survival (PFS - primary endpoint), adverse events (AEs), tolerability and feasibility of use, objective response rate and overall survival (OS', 'Median PFS']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0227599', 'cui_str': 'Urinary tract transitional epithelial cell'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2960054', 'cui_str': 'Ramphastinae'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3152967', 'cui_str': 'Vandetanib 100 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0148199', 'cui_str': 'Vascular Endothelial Growth Factor Receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1121849', 'cui_str': 'Vandetanib'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",82.0,0.528557,Toxicity ≥grade 3 was experienced in 80% (n=32) and 76% (n=32) of patients on vandetanib and placebo arms respectively.,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Beatson West of Scotland Cancer Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Crabb', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chester', 'Affiliation': 'Cardiff University, Cardiff, UK.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Elliott', 'Affiliation': 'Christie Hospital NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Huddart', 'Affiliation': 'Institute of Cancer Research, Sutton, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Birtle', 'Affiliation': 'Royal Lancaster Infirmary, Lancaster, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Evans', 'Affiliation': 'Weston Park Hospital, Sheffield, UK.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Lester', 'Affiliation': 'Velindre Cancer Centre, Cardiff, UK.'}, {'ForeName': 'Satinder', 'Initials': 'S', 'LastName': 'Jagdev', 'Affiliation': ""St. James's University Hospital, Leeds, UK.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Casbard', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Tracie-Ann', 'Initials': 'TA', 'LastName': 'Madden', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Griffiths', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}]",BJU international,['10.1111/bju.15096']
93,32315965,Baduanjin mind-body exercise improves logical memory in long-term hospitalized patients with schizophrenia: A randomized controlled trial.,"Neurocognitive impairment is one of the core symptoms in schizophrenia and poses a great challenge to effective treatment. Sixty-one long-term hospitalized patients with schizophrenia were recruited and randomly assigned to two groups: Baduanjin exercise and brisk walking. Patients in the Baduanjin group received 24 weeks of Baduanjin training (5 days/week, 40 min/day), while patients in the brisk walking group received 24 weeks of brisk walking (5 days/week, 40 min/day). Scores on the Wechsler Memory Scale, Digit Symbol Substitution Test (DSST), and the positive and negative syndrome scale were used to evaluate the logical memory (LM), processing speed, and clinical symptoms of all participants, while the score of Trail Making Test-A (TMT-A) was applied to assess the visual attention and graphomotor speed, at baseline and the 16th week and 24th week of intervention. The one-way repeated measures analysis of variance (ANOVA) was used to test the differences in neurocognitive changes between the two groups. Repeated measures ANOVA showed significant differences between the two groups in the LM immediate (F = 6.21, p = 0.003) and LM delayed (F=5.60, p = 0.005) scores, but not in the completion times of TMT-A (F=.22, p = 0.806) or DSST scores (F=0.97, p = 0.328). A significant effect of time was also detected in the LM immediate (F=10.24, p = 0.000) and LM delayed (F=4.93, p = 0.009) scores and in the completion time of the TMT-A (F=33.10, p = 0.000), but not in the DSST scores (F=2.12, p = 0.122). Baduanjin exercise could improve logical memory in the long-term hospitalized patients with schizophrenia.",2020,"Repeated measures ANOVA showed significant differences between the two groups in the LM immediate (F = 6.21, p = 0.003) and LM delayed (F=5.60, p = 0.005) scores, but not in the completion times of TMT-A (F=.22, p = 0.806) or DSST scores (F=0.97, p = 0.328).","['long-term hospitalized patients with schizophrenia', 'hospitalized patients with schizophrenia', 'Sixty-one long-term hospitalized patients with schizophrenia']","['Baduanjin exercise', 'Baduanjin training', 'brisk walking group received 24 weeks of brisk walking', 'Baduanjin exercise and brisk walking', 'Baduanjin mind-body exercise']","['LM immediate', 'logical memory (LM), processing speed, and clinical symptoms', 'neurocognitive changes', 'LM delayed', 'logical memory', 'visual attention and graphomotor speed', 'completion time of the TMT-A', 'Wechsler Memory Scale, Digit Symbol Substitution Test (DSST), and the positive and negative syndrome scale', 'DSST scores']","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C4517832', 'cui_str': '61'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443162', 'cui_str': 'Brisk'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0589102', 'cui_str': 'Visual attention'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",61.0,0.0321369,"Repeated measures ANOVA showed significant differences between the two groups in the LM immediate (F = 6.21, p = 0.003) and LM delayed (F=5.60, p = 0.005) scores, but not in the completion times of TMT-A (F=.22, p = 0.806) or DSST scores (F=0.97, p = 0.328).","[{'ForeName': 'Mingli', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""Mental Health Center and Psychiatric Laboratory, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China; The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China. Electronic address: limingli0517@qq.com.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Yusubujiang', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China. Electronic address: 577827619@qq.com.""}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.102046']
94,32303364,Learning how to break bad news from worked examples: Does the presentation format matter when hints are embedded? Results from randomised and blinded field trials.,"OBJECTIVES


Video-based worked examples enable medical students to successfully prepare for breaking-bad-news (BBN) encounters with simulated patients (SPs). This is especially true when examples include hints that signal important content. This paper investigates whether the beneficial effect of hints only applies to video-based worked examples or also text-based examples.
METHODS


One-hundred-and-forty-seven fourth-year medical students attending a BBN training participated in either of two equally scaffolded, randomised field trials. Prior to encountering SPs, the students worked through an e-learning module introducing the SPIKES protocol for delivering bad news; it contained the same worked example presented to either of four groups as text or video, with or without additional hints denoting the SPIKES steps being implemented.
RESULTS


Only a main effect of 'hints' was revealed, implying that students in the hints groups delivered the news to an SP significantly more appropriately than those in the without-hints groups.
CONCLUSIONS


Independent of their presentation format, worked examples with hints best foster students' BBN skills learning.
PRACTICE IMPLICATIONS


In addition to video, text-based worked examples can effectively prepare students for BBN simulations if hints are included. This offers an affordable alternative to video examples, as text examples can be generated with less effort.",2020,"Prior to encountering SPs, the students worked through an e-learning module introducing the SPIKES protocol for delivering bad news; it contained the same worked example presented to either of four groups as text or video, with or without additional hints denoting the SPIKES steps being implemented.
","['One-hundred-and-forty-seven fourth-year medical students attending a BBN training participated in either of two equally scaffolded, randomised field trials']",[],[],"[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0282425', 'cui_str': 'News'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],[],147.0,0.0247783,"Prior to encountering SPs, the students worked through an e-learning module introducing the SPIKES protocol for delivering bad news; it contained the same worked example presented to either of four groups as text or video, with or without additional hints denoting the SPIKES steps being implemented.
","[{'ForeName': 'Felix Michael', 'Initials': 'FM', 'LastName': 'Schmitz', 'Affiliation': 'Institute for Medical Education, University of Bern, 3010, Bern, Switzerland. Electronic address: felix.schmitz@iml.unibe.ch.'}, {'ForeName': 'Kai Philipp', 'Initials': 'KP', 'LastName': 'Schnabel', 'Affiliation': 'Institute for Medical Education, University of Bern, 3010, Bern, Switzerland. Electronic address: kai.schnabel@iml.unibe.ch.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bauer', 'Affiliation': 'Institute for Medical Education, University of Bern, 3010, Bern, Switzerland. Electronic address: daniel.bauer@iml.unibe.ch.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Woermann', 'Affiliation': 'Institute for Medical Education, University of Bern, 3010, Bern, Switzerland. Electronic address: ulrich.woermann@iml.unibe.ch.'}, {'ForeName': 'Sissel', 'Initials': 'S', 'LastName': 'Guttormsen', 'Affiliation': 'Institute for Medical Education, University of Bern, 3010, Bern, Switzerland. Electronic address: sissel.guttormsen@iml.unibe.ch.'}]",Patient education and counseling,['10.1016/j.pec.2020.03.022']
95,32329737,Facilitators and Barriers to Chronic Disease Self-Management and Mobile Health Interventions for People Living With Diabetes and Hypertension in Cambodia: Qualitative Study.,"BACKGROUND


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


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


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


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


These mHealth messages are currently being tested in a cluster randomized controlled trial (#1R21TW010160) to improve diabetes and hypertension control in Cambodia. This study has implications for practice and policies in Cambodia and other LMICs and low-resource US settings that are working to engage PEs and build community-clinical linkages to facilitate chronic disease management.",2020,"PE network participants desired mHealth to address barriers to chronic disease management through reminders about medications, laboratory tests and doctor's consultations, education on how to incorporate self-management into their daily lives, and support for obstacles to disease management.","['six focus groups (N=59) and 11 interviews in one urban municipality and five rural operating districts from three provinces in October 2016', 'semistructured interviews and focus groups with PEs and people living with diabetes and/or hypertension', '14,000 people with hypertension and/or diabetes in Cambodia', 'People Living With Diabetes and Hypertension in Cambodia']",['Facilitators and Barriers to Chronic Disease Self-Management and Mobile Health Interventions'],[],"[{'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0006797', 'cui_str': 'Cambodia'}]","[{'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.050163,"PE network participants desired mHealth to address barriers to chronic disease management through reminders about medications, laboratory tests and doctor's consultations, education on how to incorporate self-management into their daily lives, and support for obstacles to disease management.","[{'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Steinman', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Hen', 'Initials': 'H', 'LastName': 'Heang', 'Affiliation': 'MoPoTsyo Patient Information Centre, Phnom Penh, Cambodia.'}, {'ForeName': 'Maurits', 'Initials': 'M', 'LastName': 'van Pelt', 'Affiliation': 'MoPoTsyo Patient Information Centre, Phnom Penh, Cambodia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ide', 'Affiliation': 'Division of General Internal Medicine, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Cui', 'Affiliation': 'MoPoTsyo Patient Information Centre, Phnom Penh, Cambodia.'}, {'ForeName': 'Mayuree', 'Initials': 'M', 'LastName': 'Rao', 'Affiliation': 'Division of General Internal Medicine, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'LoGerfo', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Fitzpatrick', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}]",JMIR mHealth and uHealth,['10.2196/13536']
96,32329742,The Kids Obesity Prevention Program: Cluster Randomized Controlled Trial to Evaluate a Serious Game for the Prevention and Treatment of Childhood Obesity.,"BACKGROUND


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


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


This cluster randomized controlled trial collected data from 82 primary school children aged 9 to 12 years and their parents at baseline (T0), at 2 weeks after study commencement (T1), and at the 4-week follow-up (T2). The dropout rate was 3.6%. The intervention group (IG) played the game within 2 weeks (2 sessions with different game modules). One part of the game involves selection of food with the lower energy density when presented with a pair of foods. This allows assessment of whether the children have understood the DED-P and whether they can apply it to unknown foods under time pressure. The control group (CG) received a brochure about the food pyramid concept and physical activity. The primary outcome was the gain in knowledge (nutrition and stress coping) and measured with a pretested questionnaire. The secondary outcomes were the maintenance of knowledge, application of the DED-P, feelings during game play, game acceptance, and behavioral measures (physical activity, media consumption, and dietary intake).
RESULTS


The knowledge score ranging from 0 to 100 increased from T0 (IG: 53 [SD 10], CG: 50 [SD 11]) to T1 (IG: 69 [SD 11], CG: 52 [SD 12]) in IG versus CG (P<.001). At T2, the knowledge score of IG remained at the same level as that of T1. Game data showed that after DED-P education, the classification under time pressure of unknown versus known food pairs according to their DED category was similar (hit rate around 70%). Overall, 95% of the children liked the game very much or much. No group changes were observed at the behavioral level.
CONCLUSIONS


The Kids Obesity Prevention program sustainably increased knowledge in the areas of nutrition and stress coping, and children were able to apply the DED-P.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02551978; https://clinicaltrials.gov/ct2/show/NCT02551978.",2020,"The secondary outcomes were the maintenance of knowledge, application of the DED-P, feelings during game play, game acceptance, and behavioral measures (physical activity, media consumption, and dietary intake).
","['Childhood Obesity', '82 primary school children aged 9 to 12 years and their parents at baseline (T0), at 2 weeks after study commencement (T1), and at the 4-week follow-up (T2']",['control group (CG) received a brochure about the food pyramid concept and physical activity'],"['knowledge score of IG', 'maintenance of knowledge, application of the DED-P, feelings during game play, game acceptance, and behavioral measures (physical activity, media consumption, and dietary intake', 'dropout rate', 'gain in knowledge (nutrition and stress coping) and measured with a pretested questionnaire', 'behavioral level']","[{'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0034229', 'cui_str': 'Pyramidal tract structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.102248,"The secondary outcomes were the maintenance of knowledge, application of the DED-P, feelings during game play, game acceptance, and behavioral measures (physical activity, media consumption, and dietary intake).
","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Mack', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Hospital, Tübingen, Germany.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Reiband', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Hospital, Tübingen, Germany.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Etges', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Hospital, Tübingen, Germany.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Eichhorn', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Hospital, Tübingen, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Schaeffeler', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Hospital, Tübingen, Germany.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Zurstiege', 'Affiliation': 'Department of Media Studies Tübingen, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Gawrilow', 'Affiliation': 'Department of School Psychology, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weimer', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Ulm University Medical Center, Ulm, Germany.'}, {'ForeName': 'Riyad', 'Initials': 'R', 'LastName': 'Peeraully', 'Affiliation': ""Department of Paediatric Surgery, Nottingham Children's Hospital, Nottingham, United Kingdom.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Teufel', 'Affiliation': 'LVR-Clinic for Psychosomatic Medicine and Psychotherapy, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Blumenstock', 'Affiliation': 'Institute for Clinical Epidemiology and Applied Biometry, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Katrin Elisabeth', 'Initials': 'KE', 'LastName': 'Giel', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Hospital, Tübingen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Junne', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Hospital, Tübingen, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Zipfel', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Hospital, Tübingen, Germany.'}]",Journal of medical Internet research,['10.2196/15725']
97,32337693,Effect of Sheng Xue Ning Tablets on Renal Anemia in Patients Subject to Maintenance Hemodialysis and Safety Evaluation: A Multi-setting Prospective Randomized Study.,"This study compared Sheng Xue Ning (SXN) tablets with ferrous succinate (FS) tablets in terms of their efficacy for the treatment of iron-deficient renal anemia and safety in patients subject to maintenance hemodialysis (MHD). A total of 94 patients undergoing MHD were randomly assigned to an experiment group (receiving oral SXN tablets, SXN group) and a control group (orally given FS tablets, FS group) and followed up for 12 weeks. Erythropoietin (EPO) was used in both groups. The efficacy was assessed by detecting the subsequent changes in hemoglobin (Hb), serum iron (SI), SF and transferrin saturation (TSAT). At the 12th week, Hb and TSAT levels in both groups were significantly increased compared to those in the screening period (P<0.05). However, no significant difference in Hb and TSAT was found between the two groups. The average weekly EPO dosage used was lower in SXN group than in FS group (P<0.05) at the 10th week and the 12th week. Our study showed that SXN tablets can effectively ameliorate renal anemia and keep iron metabolism stable in MHD patients, and its efficacy is virtually close to that of FS tablets. Meanwhile, SXN tablets can reduce the dosage of EPO and have a good safety profile.",2020,The average weekly EPO dosage used was lower in SXN group than in FS group (P<0.05) at the 10th week and the 12th week.,"['MHD patients', '94 patients undergoing MHD', 'patients subject to maintenance hemodialysis (MHD', 'Patients Subject to Maintenance Hemodialysis and Safety Evaluation']","['Sheng Xue Ning Tablets', 'experiment group (receiving oral SXN tablets, SXN', 'Sheng Xue Ning (SXN) tablets with ferrous succinate (FS) tablets', 'Erythropoietin (EPO', 'SXN tablets']","['hemoglobin (Hb), serum iron (SI), SF and transferrin saturation (TSAT', 'Hb and TSAT', 'Hb and TSAT levels', 'renal anemia', 'Renal Anemia', 'average weekly EPO dosage']","[{'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0060281', 'cui_str': 'ferrous succinate'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1142276', 'cui_str': 'Renal anemia'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",94.0,0.0117874,The average weekly EPO dosage used was lower in SXN group than in FS group (P<0.05) at the 10th week and the 12th week.,"[{'ForeName': 'Xiao-Jing', 'Initials': 'XJ', 'LastName': 'Tang', 'Affiliation': 'Department of Nephrology, Changzheng Hospital, the Second Military Medical University, Shanghai, 20003, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Rong', 'Affiliation': 'Department of Nephrology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200080, China.'}, {'ForeName': 'Chang-Lin', 'Initials': 'CL', 'LastName': 'Mei', 'Affiliation': 'Department of Nephrology, Changzheng Hospital, the Second Military Medical University, Shanghai, 20003, China. chlmei1954@126.com.'}, {'ForeName': 'Zhao-Hui', 'Initials': 'ZH', 'LastName': 'Ni', 'Affiliation': 'Department of Nephrology, Renji Hospital, Jiaotong University, Shanghai, 200003, China.'}, {'ForeName': 'Geng-Ru', 'Initials': 'GR', 'LastName': 'Jiang', 'Affiliation': 'Department of Nephrology, Xinhua Hospital, Jiaotong University, Shanghai, 200092, China.'}, {'ForeName': 'Wei-Jie', 'Initials': 'WJ', 'LastName': 'Yuan', 'Affiliation': 'Department of Nephrology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200080, China.'}, {'ForeName': 'Nian-Song', 'Initials': 'NS', 'LastName': 'Wang', 'Affiliation': ""Department of Nephrology, the Sixth People's Hospital, Jiaotong University, Shanghai, 200233, China.""}, {'ForeName': 'Zhi-Yong', 'Initials': 'ZY', 'LastName': 'Guo', 'Affiliation': 'Department of Nephrology, Changhai Hospital, the Second Military Medical University, Shanghai, 200433, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Nephrology, Tongji Hospital, Tongji University, Shanghai, 200065, China.'}, {'ForeName': 'Hai-Dong', 'Initials': 'HD', 'LastName': 'Yan', 'Affiliation': 'Department of Nephrology, East Hospital, Tongji University, Shanghai, 200120, China.'}, {'ForeName': 'Li-Ming', 'Initials': 'LM', 'LastName': 'ZHang', 'Affiliation': 'Department of Nephrology, Zhabei District Central Hospital, Changzhen Hospital, Shanghai, 200070, China.'}]",Current medical science,['10.1007/s11596-020-2179-z']
98,32337698,Efficacy of Electro-acupuncture in Treatment of Functional Constipation: A Randomized Controlled Trial.,"Functional constipation (FC) is a chronic disease that significantly affects the life quality of patients. Acupuncture has been used for the treatment of FC for many years, but its effectiveness has not been scientifically assessed. The present study aimed to evaluate the efficacy of electro-acupuncture (EA) in relieving the symptoms, mental states and quality of life (QOL) of FC patients. A total of 96 FC patients were randomly allocated into EA, mosapride & sham EA group (MS) and mosapride control group (MC). In the EA group, patients were treated with 16 sessions of needling at Quchi (LI11) and Shangjuxu (ST37) bilaterally, 5 times a week in the first 2 weeks, and 3 times a week in the last 2 weeks. In the MC group, patients were treated with 5 mg mosapride citrate three times a day for 4 weeks. In the MS group, patients underwent sham EA and the same mosapride citrate treatment as in the MC group. The primary outcome was the number of weekly spontaneous bowel movements (SBMs). The secondary outcomes included stool consistency, intensity of defecating difficulty, 36-Item Short-Form Health Survey (SF-36), Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), and the validated Patient Assessment of Constipation-Quality of Life (PAC-QOL). The results showed that as compared with the baseline, EA significantly improved the weekly SBMs, stool consistency and intensity of defecating difficulty (P<0.05). It also partly ameliorated the PAC-QOL, SF-36, SDS and SAS scores when compared with MC or MS group (P<0.05). However, no significant difference was observed between MS and MC groups in bowel function outcomes and QOL scores. It was concluded that EA could effectively improve bowel function, mental states and QOL of FC patients.",2020,"It also partly ameliorated the PAC-QOL, SF-36, SDS and SAS scores when compared with MC or MS group (P<0.05).","['96 FC patients', 'Functional Constipation']","['electro-acupuncture (EA', 'EA, mosapride & sham', 'Acupuncture', 'Electro-acupuncture', 'EA']","['bowel function outcomes and QOL scores', 'bowel function, mental states and QOL', 'stool consistency, intensity of defecating difficulty, 36-Item Short-Form Health Survey (SF-36), Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), and the validated Patient Assessment of Constipation-Quality of Life (PAC-QOL', 'number of weekly spontaneous bowel movements (SBMs', 'weekly SBMs, stool consistency and intensity of defecating difficulty', 'symptoms, mental states and quality of life (QOL', 'Functional constipation (FC', 'PAC-QOL, SF-36, SDS and SAS scores']","[{'cui': 'C0401146', 'cui_str': 'Constipation - functional'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0526501', 'cui_str': 'mosapride'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0033036', 'cui_str': 'Atrial premature complex'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional'}]",96.0,0.0313138,"It also partly ameliorated the PAC-QOL, SF-36, SDS and SAS scores when compared with MC or MS group (P<0.05).","[{'ForeName': 'Xiao-Hu', 'Initials': 'XH', 'LastName': 'Xu', 'Affiliation': 'Department of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Ming-Min', 'Initials': 'MM', 'LastName': 'Zhang', 'Affiliation': 'Department of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Sha-Bei', 'Initials': 'SB', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Cui-Hong', 'Initials': 'CH', 'LastName': 'Zheng', 'Affiliation': 'Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China. chzheng@tjh.tjmu.edu.cn.'}, {'ForeName': 'Guang-Ying', 'Initials': 'GY', 'LastName': 'Huang', 'Affiliation': 'Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China. gyhuang@tjh.tjmu.edu.cn.'}]",Current medical science,['10.1007/s11596-020-2188-y']
99,32337700,Effect of Nalmefene on Delayed Neurocognitive Recovery in Elderly Patients Undergoing Video-assisted Thoracic Surgery with One Lung Ventilation.,"The intravenous use of nalmefene has been found to exert neuroprotective effect in patients with severe traumatic brain injury and acute cerebral infarction; nonetheless, it is unknown whether nalmefene alleviates delayed neurocognitive recovery. Our purpose of the current research was to clarify the impact of nalmefene on delayed neurocognitive recovery in aged patients experiencing video-assisted thoracic surgery (VATS) with intraoperative use of one lung ventilation (OLV). The present study involved 120 patients undergoing selective VATS, randomized to accept low-dose nalmefene (N1 group, n=40), high-dose nalmefene (N2 group, n=40) or equal volume of physiologic saline (control group, n=40). A battery of neuropsychological tests were used to estimate cognitive function 1 day before surgery (t 0 ) and 10 days after surgery or before discharge (t 1 ). Regional cerebral oxygen saturation (rSO 2 ) was detected 5 min before induction (t 0 ), 5 min after induction (t 1 ), 15 and 60 min after onset of OLV (t 2  and t 3 ), and 15 min after termination of OLV (t 4 ). The plasma values of interleukin (IL)-1β, IL-6, tumor necrosis factor (TNF)-α and adiponectin (ADP) were also detected prior to induction of anesthesia (T0), 1 h, 2 h and 6 h after surgery (T1, T2, T3). On t 1 , delayed neurocognitive recovery occurred in 5/40 (12.5%) patients of N1 group, in 5/40 (12.5%) patients of N2 group and in 13/40 (32.5%) patients of control group (P0.05). There were no statistical differences in rSO 2  among three groups at different time points. At T1, T2 and T3, IL-1β, IL-6 and TNF-α values significantly increased and ADP value significantly decreased (P0.05) in control group. In contrast, at T1, T2 and T3, IL-1β, IL-6 and TNF-α values decreased and ADP value decreased less in N1 and N2 groups (P0.05). At T1, T2 and T3, IL-1β, IL-6 and TNF-α concentrations presented a trend of N2 group N1 group control group and ADP presented a trend of N2 groupN1 groupcontrol group (P0.05). The result of our present research supports the hypothesis that the perioperative intravenous treatment with nalmefene to VATS with OLV ameliorates postoperative cognitive function and decreases the incidence of delayed neurocognitive recovery, most likely by suppression of inflammatory responses.",2020,"At T1, T2 and T3, IL-1β, IL-6 and TNF-α concentrations presented a trend of N2 group N1 group control group and ADP presented a trend of N2 groupN1 groupcontrol group (P0.05).","['patients with severe traumatic brain injury and acute cerebral infarction', 'aged patients experiencing video-assisted thoracic surgery (VATS) with intraoperative use of one lung ventilation (OLV', 'Elderly Patients Undergoing Video-assisted Thoracic Surgery with One Lung Ventilation', '120 patients undergoing selective VATS, randomized to accept low-dose nalmefene (N1 group, n=40']","['Nalmefene', 'high-dose nalmefene (N2 group, n=40) or equal volume of physiologic saline (control']","['T2 and T3, IL-1β, IL-6 and TNF-α values', 'delayed neurocognitive recovery', 'ADP value', 'plasma values of interleukin (IL)-1β, IL-6, tumor necrosis factor (TNF)-α and adiponectin (ADP', 'Regional cerebral oxygen saturation (rSO 2 ', 'T2 and T3, IL-1β, IL-6 and TNF-α concentrations', 'postoperative cognitive function', 'T2 and T3, IL-1β, IL-6 and TNF-α values decreased and ADP value', 'Delayed Neurocognitive Recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0068377', 'cui_str': 'nalmefene'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0068377', 'cui_str': 'nalmefene'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0001459', 'cui_str': 'Adenosine diphosphate'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",120.0,0.0301072,"At T1, T2 and T3, IL-1β, IL-6 and TNF-α concentrations presented a trend of N2 group N1 group control group and ADP presented a trend of N2 groupN1 groupcontrol group (P0.05).","[{'ForeName': 'Meng-Yun', 'Initials': 'MY', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Zhongnan Hospital, Wuhan University, Wuhan, 430071, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Zhongnan Hospital, Wuhan University, Wuhan, 430071, China.'}, {'ForeName': 'Zheng-Gang', 'Initials': 'ZG', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Zhongnan Hospital, Wuhan University, Wuhan, 430071, China.'}, {'ForeName': 'Jian-Juan', 'Initials': 'JJ', 'LastName': 'Ke', 'Affiliation': 'Department of Anesthesiology, Zhongnan Hospital, Wuhan University, Wuhan, 430071, China.'}, {'ForeName': 'Xiao-Bo', 'Initials': 'XB', 'LastName': 'Feng', 'Affiliation': 'Department of Anesthesiology, Zhongnan Hospital, Wuhan University, Wuhan, 430071, China. 283647213@qq.com.'}]",Current medical science,['10.1007/s11596-020-2170-8']
100,32337864,Can 3D Vision Improve Laparoscopic Performance in Box Simulation Training when Compared to Conventional 2D Vision?,"INTRODUCTION


Three-dimensional (3D) imaging systems have been introduced in laparoscopic surgery to facilitate binocular vision and dexterity to improve surgical performance and safety. Several studies have shown the benefits of 3D imaging in laparoscopy, but until now only a few studies have assessed the outcome by using objective variables. Box trainers are affordable alternatives to virtual laparoscopic surgical training, and the possibility of using real surgical instruments makes them more realistic to use. However, the data and feedback by a virtual simulator have not, until now, been able to assess. Simball Box®, equipped with G-coder sensors®, registers the instrument movements during training and gives the same feedback like a virtual simulator.
AIM


The aim of this study was to objectively evaluate the laparoscopic performance in 3D compared to conventional 2D vision by using a box simulation trainer.
MATERIALS AND METHODS


Thirty surgeons, residents and consultants, participated in the study. Eighteen had no, or minimal, laparoscopic experience (novices) whereas 12 were experts. They all performed three standard box training exercises (rope race, precision cutting, and basic suturing) in Simball Box. The participants were randomized and started with either 3D HD or traditional 2D HD cameras. The exercises were instructed and supervised. All instrument movements were registered. Variations in time, linear distance, average speed, and motion smoothness were analyzed.
RESULTS


The parameters time, distance, speed, and motion smoothness were significantly better when the 3D camera was used.
CONCLUSION


All individuals of both subgroups achieved significantly higher speed and better motion smoothness when using 3D.",2019,All individuals of both subgroups achieved significantly higher speed and better motion smoothness when using 3D.,"['Thirty surgeons, residents and consultants, participated in the study', 'Eighteen had no, or minimal, laparoscopic experience (novices) whereas 12 were experts']","['conventional 2D vision', '3D HD or traditional 2D HD cameras', 'standard box training exercises (rope race, precision cutting, and basic suturing) in Simball Box']","['Variations in time, linear distance, average speed, and motion smoothness', 'laparoscopic performance', 'higher speed and better motion smoothness', 'parameters time, distance, speed, and motion smoothness']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",30.0,0.0409468,All individuals of both subgroups achieved significantly higher speed and better motion smoothness when using 3D.,"[{'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Österberg', 'Affiliation': 'Mora Hospital, Mora, Sweden.'}, {'ForeName': 'Arestis', 'Initials': 'A', 'LastName': 'Sokratous', 'Affiliation': 'Mora Hospital, Mora, Sweden.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Georgiou', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Enochsson', 'Affiliation': 'Umeå University, Umeå, Sweden.'}]",Folia medica,['10.3897/folmed.61.e47958']
101,32196898,Safety and efficacy of step-down to oral outpatient treatment versus inpatient antimicrobial treatment in pediatric cancer patients with febrile neutropenia: A noninferiority multicenter randomized clinical trial.,"BACKGROUND


It has been suggested that low-risk febrile neutropenia (FN) episodes can be treated in a step-down manner in the outpatient setting. This recommendation has been limited to implementation in middle-income countries due to concerns about infrastructure and lack of trained personnel. We aimed to determine whether early step-down to oral antimicrobial outpatient treatment is not inferior in safety and efficacy to inpatient intravenous treatment in children with low-risk FN.
PROCEDURE


A noninferiority randomized controlled clinical trial was conducted in three hospitals in Mexico City. Low-risk FN was identified in children younger than 18 years. After 48 to 72 hours of intravenous treatment, children were randomly allocated to receive outpatient oral treatment (experimental arm, cefixime) or to continue inpatient treatment (standard of care, cefepime). Daily monitoring was performed until neutropenia resolution. The presence of any unfavorable clinical outcome was the endpoint of interest. We performed a noninferiority test for comparison of proportions.
RESULTS


We identified 1237 FN episodes; 117 cases were randomized: 60 to the outpatient group and 57 for continued inpatient treatment. Of the FN episodes, 100% in the outpatient group and 93% in the inpatient group had a favorable outcome (P < 0.001). The mean duration of antibiotics was 4.1 days (SD 2.5; 95% CI, 3.4-4.8 days) in the outpatient group and 4.4 days (SD 2.5; 95% CI, 3.7-5.0 days) in the inpatient group (P = 0.70).
CONCLUSIONS


In our population, step-down oral outpatient treatment of low-risk FN was as safe and effective as inpatient intravenous treatment. Clinical Trials Identifier: NCT04000711.",2020,"In our population, step-down oral outpatient treatment of low-risk FN was as safe and effective as inpatient intravenous treatment.","['1237 FN episodes; 117 cases were randomized: 60 to the outpatient group and 57 for continued inpatient treatment', 'children younger than 18 years', 'children with low-risk FN', 'pediatric cancer patients with febrile neutropenia', 'three hospitals in Mexico City']","['outpatient oral treatment (experimental arm, cefixime', 'step-down to oral outpatient treatment versus inpatient antimicrobial treatment']","['Safety and efficacy', 'safety and efficacy', 'mean duration of antibiotics']","[{'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0060400', 'cui_str': 'Cefixime'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}]",117.0,0.139808,"In our population, step-down oral outpatient treatment of low-risk FN was as safe and effective as inpatient intravenous treatment.","[{'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Avilés-Robles', 'Affiliation': 'Infectious Diseases Department, Hospital Infantil de México Federico Gómez, Mexico City, Mexico.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Reyes-López', 'Affiliation': 'Center of Economics and Social Studies in Health, Hospital Infantil de México Federico Gómez, Mexico City, Mexico.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Otero-Mendoza', 'Affiliation': 'Infectious Diseases Department, Instituto Nacional de Pediatría, Mexico City, Mexico.'}, {'ForeName': 'Amilcar U', 'Initials': 'AU', 'LastName': 'Valencia-Garin', 'Affiliation': 'Division of Pediatric, Hospital Juárez de México, Mexico City, Mexico.'}, {'ForeName': 'José G', 'Initials': 'JG', 'LastName': 'Peñaloza-González', 'Affiliation': 'Division of Pediatric, Hospital Juárez de México, Mexico City, Mexico.'}, {'ForeName': 'Rómulo E', 'Initials': 'RE', 'LastName': 'Rosales-Uribe', 'Affiliation': 'Subdivision of Integral Attention to the Patient, Hospital Infantil de México Federico Gómez, Mexico City, Mexico.'}, {'ForeName': 'Onofre', 'Initials': 'O', 'LastName': 'Muñoz-Hernández', 'Affiliation': 'National Medical Arbitration Commission, Mexico City, Mexico.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Garduño-Espinosa', 'Affiliation': 'Research Department, Hospital Infantil de México Federico Gómez, Mexico City, Mexico.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Juárez-Villegas', 'Affiliation': 'Oncology Department, Hospital Infantil de México Federico Gómez, Mexico City, Mexico.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Zapata-Tarrés', 'Affiliation': 'Oncology Department, Instituto Nacional de Pediatría, Mexico City, Mexico.'}]",Pediatric blood & cancer,['10.1002/pbc.28251']
102,30326271,Operant Learning Versus Energy Conservation Activity Pacing Treatments in a Sample of Patients With Fibromyalgia Syndrome: A Pilot Randomized Controlled Trial.,"This study's aim was to assess the efficacy of 2 forms of activity pacing in patients with fibromyalgia syndrome (FMS). Treatment-related changes in activity management patterns were also examined. Patients with FMS (n = 178) were randomly assigned to an operant learning (OL; delayed [n = 36] or immediate [n = 54] groups) or an energy conservation (EC; delayed [n = 35] or immediate [n = 53] groups) treatment condition. Of these, 32 OL and 37 EC patients completed treatment. Forty-three patients were allocated to the delayed treatment condition (control group). Repeated measures analyses of variance were used to examine the effects of OL and EC treatments on primary (average pain and usual fatigue), secondary (pain and fatigue interference, physical and psychological function, sleep quality, depressive symptoms, and anxiety symptoms), and tertiary (pain-related activity patterns) outcomes. Neither treatment was effective in reducing average pain or usual fatigue symptoms. Relative to EC, OL patients showed greater improvements in depressive symptoms, whereas nonsignificant trends (P values ranging between .05 and .06) were observed for pain interference, fatigue interference, and psychological function. Both treatments were associated with improvements in sleep quality and physical function, increases in pacing, and decreases in overdoing activity patterns. Reductions in activity avoidance were only found in OL. These findings suggest that OL may be more beneficial than EC and that it could potentially be viewed as an effective stand-alone activity pacing treatment for patients with FMS. Research to determine the extent to which these preliminary findings replicate is warranted. PERSPECTIVE: This article examines the efficacy of 2 forms of activity pacing in patients with fibromyalgia syndrome. The results suggest the possibility that operant learning may be more beneficial than energy conservation and could potentially be viewed as an effective stand-alone activity pacing treatment for patients with fibromyalgia syndrome.",2019,"Both treatments were associated with improvements in sleep quality and physical function, increases in pacing, and decreases in overdoing activity patterns.","['patients with fibromyalgia syndrome', 'Patients With Fibromyalgia Syndrome', 'patients with fibromyalgia syndrome (FMS', 'patients with FMS', 'Patients with FMS (n\u202f=\u202f178']","['Operant Learning Versus Energy Conservation Activity Pacing Treatments', 'operant learning (OL; delayed [n\u202f=\u202f36] or immediate [n\u202f=\u202f54] groups) or an energy conservation (EC; delayed [n\u202f=\u202f35] or immediate [n\u202f=\u202f53] groups) treatment condition', 'activity pacing']","['average pain or usual fatigue symptoms', 'pain interference, fatigue interference, and psychological function', 'sleep quality and physical function, increases in pacing, and decreases in overdoing activity patterns', 'activity avoidance', 'depressive symptoms', 'activity management patterns', 'primary (average pain and usual fatigue), secondary (pain and fatigue interference, physical and psychological function, sleep quality, depressive symptoms, and anxiety symptoms), and tertiary (pain-related activity patterns) outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1621943', 'cui_str': 'Energy conservation'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439053', 'cui_str': 'Fatigue - symptom (finding)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0233398', 'cui_str': 'Psychological function'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}]",178.0,0.0237893,"Both treatments were associated with improvements in sleep quality and physical function, increases in pacing, and decreases in overdoing activity patterns.","[{'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Racine', 'Affiliation': ""Lawson Health Research Institute, London, Ontario, Canada; Department of Clinical Neurological Sciences, Schulich School of Medicine & Dentistry, Western University, London, Ontario, Canada; Beryl & Richard Ivey Rheumatology Day Programs, St. Joseph's Health Care, London, Ontario, Canada. Electronic address: melanie.racine@gmail.com.""}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Jensen', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Harth', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Morley-Forster', 'Affiliation': 'Department of Anaesthesia and Perioperative Medicine, Western University, London, Ontario, Canada.'}, {'ForeName': 'Warren R', 'Initials': 'WR', 'LastName': 'Nielson', 'Affiliation': ""Lawson Health Research Institute, London, Ontario, Canada; Beryl & Richard Ivey Rheumatology Day Programs, St. Joseph's Health Care, London, Ontario, Canada; Department of Psychology, Western University, London, Ontario, Canada.""}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2018.09.013']
103,30368018,"Fulranumab as Adjunctive Therapy for Cancer-Related Pain: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study.","This randomized, double-blind (DB), placebo-controlled, phase 2 study assessed the efficacy and safety of fulranumab as a pain therapy adjunctive to opioids in terminally ill cancer patients. Ninety-eight patients were randomized (2:1) to receive one subcutaneous injection of fulranumab (9 mg) or placebo in the 4-week DB phase. Seventy-one (72%) patients entered the 48-week open-label extension phase and were administered 9 mg of fulranumab every 4 weeks. The study failed to demonstrated efficacy at the end of the DB phase (primary endpoint, mean [SD] change in average cancer-related pain intensity was -.8 (1.26) for fulranumab and -.7 (1.56) for placebo; P = .592). However, potential benefit is suggested based on secondary endpoints (30% responder rate [P = .020], Brief Pain Inventory-Short Form [BPI-SF] pain intensity subscale [P = .003], and pain interference subscale [P = .006]). The most commonly reported treatment-emergent adverse events were (fulranumab vs placebo): asthenia (16% vs 10%), decreased appetite (12% vs 6%), fatigue (10% vs 0%), and malignant neoplasm progression (10% vs 0%). Although no differences were seen between fulranumab and placebo groups on the primary endpoint, improvements in BPI-SF pain subscale scores and responder rates support further research of anti-nerve growth factor therapy in cancer-related pain. PERSPECTIVE: Efficacy and safety of fulranumab as adjunctive pain therapy in terminally ill cancer patients were assessed. Results suggest that anti-NGF agents may prove to be novel additions in helping to optimize pain relief in cancer patients who fail to respond adequately to opioids and other common co-analgesics.",2019,"Although no differences were seen between fulranumab and placebo groups on the primary endpoint, improvements in BPI-SF pain subscale scores and responder rates support further research of anti-nerve growth factor therapy in cancer-related pain.","['Cancer-Related Pain', 'cancer patients who fail to respond adequately to opioids and other common co-analgesics', 'Ninety-eight patients', 'terminally ill cancer patients', 'Seventy-one (72']","['Fulranumab', 'placebo', 'Placebo', 'fulranumab', 'subcutaneous injection of fulranumab (9 mg) or placebo']","['decreased appetite', 'fatigue', 'treatment-emergent adverse events', 'pain interference subscale', 'average cancer-related pain intensity', 'BPI-SF pain subscale scores and responder rates support further research of anti-nerve growth factor therapy in cancer-related pain', 'Brief Pain Inventory-Short Form [BPI-SF] pain intensity subscale', 'malignant neoplasm progression', 'efficacy and safety']","[{'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C0039552', 'cui_str': 'Terminally Ill'}, {'cui': 'C0450389', 'cui_str': '71 (qualifier value)'}]","[{'cui': 'C2981231', 'cui_str': 'fulranumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}, {'cui': 'C0651569', 'cui_str': ""9-(1'-hydroxy-2'-(hydroxymethyl)ethoxy)methylguanine""}]","[{'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0035168'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0948048', 'cui_str': 'Malignant neoplasm progression'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",98.0,0.537452,"Although no differences were seen between fulranumab and placebo groups on the primary endpoint, improvements in BPI-SF pain subscale scores and responder rates support further research of anti-nerve growth factor therapy in cancer-related pain.","[{'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Slatkin', 'Affiliation': 'School of Medicine, University of California - Riverside, California. Electronic address: neal.slatkin@salix.com.'}, {'ForeName': 'Naim', 'Initials': 'N', 'LastName': 'Zaki', 'Affiliation': 'Janssen Research & Development, LLC, Titusville, New Jersey.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Janssen Research & Development, LLC, Titusville, New Jersey.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Louie', 'Affiliation': 'Janssen Research & Development, LLC, Fremont, California.'}, {'ForeName': 'Panna', 'Initials': 'P', 'LastName': 'Sanga', 'Affiliation': 'Janssen Research & Development, LLC, Titusville, New Jersey.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Kelly', 'Affiliation': 'Janssen Research & Development, LLC, Titusville, New Jersey.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Thipphawong', 'Affiliation': 'Janssen Research & Development, LLC, Fremont, California.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2018.09.014']
104,31988102,"Fourteen-Day Bactericidal Activity, Safety, and Pharmacokinetics of Linezolid in Adults with Drug-Sensitive Pulmonary Tuberculosis.","Linezolid is increasingly used for the treatment of tuberculosis resistant to first-line agents, but the most effective dosing strategy is yet unknown. From November 2014 to November 2016, we randomized 114 drug-sensitive treatment-naive pulmonary tuberculosis patients from Cape Town, South Africa, to one of six 14-day treatment arms containing linezolid at 300 mg once daily (QD), 300 mg twice daily (BD), 600 mg QD, 600 mg BD, 1,200 mg QD, 1,200 mg three times per week (TIW), or a combination of isoniazid, rifampin, pyrazinamide, and ethambutol. Sixteen-hour sputum samples were collected overnight, and bactericidal activity was characterized by the daily percentage change in time to positivity (TTP) and the daily rate of change in log 10 (CFU). We also assessed the safety and pharmacokinetics of the study treatments. We found that bactericidal activity increased with increasing doses of linezolid. Based on the daily percentage change in TTP, activity was highest for 1,200 mg QD (4.5%; 95% Bayesian confidence interval [BCI], 3.3 to 5.6), followed by 600 mg BD (4.1%; BCI, 2.5 to 5.7), 600 mg QD (4.1%; BCI, 2.9 to 5.3), 300 mg BD (3.3%; BCI, 1.9 to 4.7), 300 mg QD (2.3%; BCI, 1.1 to 3.5), and 1,200 mg TIW (2.2%; BCI, 1.1 to 3.3). Similar results were seen with bactericidal activity characterized by the daily rate of change in CFU count. Antimycobacterial activity correlated positively with plasma drug exposure and percentage time over MIC. There were no unexpected adverse events. All linezolid doses showed bactericidal activity. For the same total daily dose, once-daily dosing proved to be at least as effective as a divided twice-daily dose. An intermittent dosing regimen, with 1,200 mg given three times weekly, showed the least activity. (This study has been registered at ClinicalTrials.gov under identifier NCT02279875.).",2020,"For the same total daily dose, once daily dosing proved to be at least as effective as a divided twice daily dose.","['114 drug-sensitive treatment-naïve pulmonary tuberculosis patients from Cape Town, South Africa', 'November 2014 and November 2016', 'Adults with Drug-Sensitive Pulmonary Tuberculosis']","['linezolid', 'Linezolid', 'isoniazid, rifampicin, pyrazinamide and ethambutol']","['TTP, activity', 'bactericidal activity', 'safety and pharmacokinetics', 'adverse events', 'Bactericidal activity', 'Antimycobacterial activity', 'time to positivity (TTP) and colony forming units (CFU', 'daily rate of change in CFU count']","[{'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0663241', 'cui_str': 'linezolid'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0034239', 'cui_str': 'Pyrazinamide'}, {'cui': 'C0014964', 'cui_str': 'Ethambutol'}]","[{'cui': 'C0034155', 'cui_str': 'Moschkowitz Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0544570', 'cui_str': 'Bactericidal activity (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0360390', 'cui_str': 'Anti-Mycobacterial Agents'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",,0.0294071,"For the same total daily dose, once daily dosing proved to be at least as effective as a divided twice daily dose.","[{'ForeName': 'Andreas H', 'Initials': 'AH', 'LastName': 'Diacon', 'Affiliation': 'Division of Pulmonology, Department of Medicine, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa ahd@sun.ac.za.'}, {'ForeName': 'Veronique R', 'Initials': 'VR', 'LastName': 'De Jager', 'Affiliation': 'Task Applied Science, Bellville, South Africa.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Dawson', 'Affiliation': 'Division of Pulmonology, Department of Medicine, Groote Schuur Hospital and University of Cape Town Lung Institute, Cape Town, South Africa.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Narunsky', 'Affiliation': 'Division of Pulmonology, Department of Medicine, Groote Schuur Hospital and University of Cape Town Lung Institute, Cape Town, South Africa.'}, {'ForeName': 'Naadira', 'Initials': 'N', 'LastName': 'Vanker', 'Affiliation': 'Task Laboratory, Parow, South Africa.'}, {'ForeName': 'Divan A', 'Initials': 'DA', 'LastName': 'Burger', 'Affiliation': 'Department of Statistics, University of Pretoria, Pretoria, South Africa.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Everitt', 'Affiliation': 'TB Alliance, New York, New York, USA.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Pappas', 'Affiliation': 'TB Alliance, New York, New York, USA.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Nedelman', 'Affiliation': 'TB Alliance, New York, New York, USA.'}, {'ForeName': 'Carl M', 'Initials': 'CM', 'LastName': 'Mendel', 'Affiliation': 'TB Alliance, New York, New York, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.02012-19']
105,31602965,"Effects of propofol, desflurane, and sevoflurane on respiratory functions following endoscopic endonasal transsphenoidal pituitary surgery: a prospective randomized study.","BACKGROUND


General anesthesia with intravenous or inhalation anesthetics reduces respiratory functions. We investigated the effects of propofol, desflurane, and sevoflurane on postoperative respiratory function tests.
METHODS


This single-center randomized controlled study was performed in a university hospital from October 2015 to February 2017. Ninety patients scheduled for endoscopic endonasal transsphenoidal pituitary surgery were randomly categorized into either of these three groups: propofol (n = 30, the Group TIVA), desflurane (n = 30, the Group D) or sevoflurane (n = 30, the Group S). We analyzed the patients before, after, and 24 h following surgery, to identify the following parameters: forced expiratory volume in 1 second (FEV1) %, forced vital capacity (FVC) %, FEV1/FVC, and arterial blood gases (ABG). Furthermore, we also recorded the intraoperative dynamic lung compliance and airway resistance values.
RESULTS


We did not find any significant differences in FEV1 values (primary outcome) among the groups (P = 0.336). There was a remarkable reduction in the FEV1 and FVC values in all groups postoperatively relative to the baseline (P < 0.001). The FVC, FEV1/FVC, ABG analysis, compliance, and airway resistance were similar among the groups. Intraoperative dynamic compliance values were lower at the 1st and 2nd hours than those immediately after intubation (P < 0.001).
CONCLUSIONS


We demonstrated that propofol, desflurane, and sevoflurane reduced FEV1 and FVC values postoperatively, without any significant differences among the drugs.",2019,"The FVC, FEV1/FVC, ABG analysis, compliance and airway resistance were similar among the groups.","['university hospital from October 2015 to February 2017', 'endoscopic endonasal transsphenoidal pituitary surgery', 'Ninety patients scheduled for endoscopic endonasal transsphenoidal pituitary surgery']","['inhalation anesthetics', 'propofol, desflurane and sevoflurane', 'propofol', 'desflurane', 'sevoflurane']","['respiratory functions', 'Intraoperative dynamic lung compliance and airway resistance values', 'FVC, FEV1/FVC, ABG analysis, compliance and airway resistance', 'FEV1 and FVC values', 'Intraoperative dynamic compliance', 'Forced expiratory volume in 1 seconds (FEV1) %, forced vital capacity (FVC) %, FEV1/ FVC, and arterial blood gases (ABG) analysis', 'FEV1 values']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0205508', 'cui_str': 'Transsphenoidal approach (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}]","[{'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0024112', 'cui_str': 'Lung Compliance'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0429680', 'cui_str': 'Dynamic compliance (observable entity)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}]",90.0,0.0466171,"The FVC, FEV1/FVC, ABG analysis, compliance and airway resistance were similar among the groups.","[{'ForeName': 'Abdulvahap', 'Initials': 'A', 'LastName': 'Oguz', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Cerrahpasa School of Medicine, University of Istanbul-Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Eren Fatma', 'Initials': 'EF', 'LastName': 'Akcil', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Cerrahpasa School of Medicine, University of Istanbul-Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Tunali', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Cerrahpasa School of Medicine, University of Istanbul-Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Hayriye', 'Initials': 'H', 'LastName': 'Vehid', 'Affiliation': 'Department of Biostatistics, Cerrahpasa School of Medicine, University of Istanbul-Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Ozlem Korkmaz', 'Initials': 'OK', 'LastName': 'Dilmen', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Cerrahpasa School of Medicine, University of Istanbul-Cerrahpasa, Istanbul, Turkey.'}]",Korean journal of anesthesiology,['10.4097/kja.19336']
106,31096728,The effect of anesthetic techniques on neutrophil to lymphocyte ratio in patients undergoing infraumbilical surgeries.,"BACKGROUND


Neutrophil to lymphocyte ratio (NLR) is a simple marker in peripheral blood and is used to assess inflammatory response and physiological stress during the peri-operative period. Anesthetic technique may influence NLR, thereby modulating the inflammatory response and surgical outcomes. The study aimed to evaluate the relationship between blood NLR and anesthetic techniques in patients undergoing infraumbilical surgeries.
METHODS


Institutional ethical committee approval and patient consent were obtained. A prospective randomized double- blinded study was conducted between July 2017 and November 2017, involving 80 patients classified as the American Society of Anesthesiologists grade 1 and 2, aged 18-60 years, and scheduled for elective infraumbilical surgeries. Unwilling and those with infections were excluded. The patients were randomly divided into two groups: Group G (general anesthesia) and Group S (spinal anesthesia) as per the standardized protocol. Differential counts of leukocytes and NLR in the peripheral blood were obtained pre-operatively on the morning of surgery and at 2 h and 24 h after surgery in both the groups. The data were analyzed using appropriate statistical tests.
RESULTS


The demographic parameters, basal total leukocyte count (TLC), and NLR were comparable between the groups. TLC and NLR were significantly higher in Group G as compared to that in Group S post-operatively. The post-operative rise in TLC and NLR from the basal values was significantly higher in Group G as compared to that in Group S.
CONCLUSIONS


General anesthesia was associated with a greater increase in TLC and NLR when compared with spinal anesthesia.",2019,"The post-operative increase in TLC and NLR from basal values was significantly higher in Group G compared to Group S.
Conclusions


General anesthesia is associated with greater increases in TLC and NLR compared to sub arachnoid block.","['Patients refusal, those with ongoing acute infections, electrolyte abnormalities were excluded from study', 'July 2017-November 2017, involving 80 ASA 1 and 2 patients, aged 18-60 years scheduled for elective infraumbilical surgeries', 'patients undergoing infraumbilical surgeries']","['\n\n\nNeutrophil/lymphocyte ratio (NLR', 'Group G receiving general anesthesia and Group S receiving spinal anesthesia', 'anesthetic techniques']","['TLC and NLR', 'differential counts of leukocytes with NLR of peripheral blood', 'TLC and NLR from basal values', 'basal Total Leukocyte Count (TLC) and NLR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0275518', 'cui_str': 'Acute infectious disease (disorder)'}, {'cui': 'C0151613', 'cui_str': 'Electrolytes abnormal (finding)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0441841', 'cui_str': 'Group G (qualifier value)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0441853', 'cui_str': 'Group S (qualifier value)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0040509', 'cui_str': 'Total Lung Capacity'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}]",,0.0388861,"The post-operative increase in TLC and NLR from basal values was significantly higher in Group G compared to Group S.
Conclusions


General anesthesia is associated with greater increases in TLC and NLR compared to sub arachnoid block.","[{'ForeName': 'Nethra', 'Initials': 'N', 'LastName': 'Surhonne', 'Affiliation': 'Department of Anesthesiology, Victoria Hospital, Bangalore Medical College and Research Institute, Bangalore, India.'}, {'ForeName': 'Chaithali', 'Initials': 'C', 'LastName': 'Hebri', 'Affiliation': 'Department of Anesthesiology, Victoria Hospital, Bangalore Medical College and Research Institute, Bangalore, India.'}, {'ForeName': 'Sudheesh', 'Initials': 'S', 'LastName': 'Kannan', 'Affiliation': 'Department of Anesthesiology, Victoria Hospital, Bangalore Medical College and Research Institute, Bangalore, India.'}, {'ForeName': 'Devika Rani', 'Initials': 'DR', 'LastName': 'Duggappa', 'Affiliation': 'Department of Anesthesiology, Victoria Hospital, Bangalore Medical College and Research Institute, Bangalore, India.'}, {'ForeName': 'Raghavendra Rao', 'Initials': 'RR', 'LastName': 'Rs', 'Affiliation': 'Department of Anesthesiology, Victoria Hospital, Bangalore Medical College and Research Institute, Bangalore, India.'}, {'ForeName': 'Chethana G', 'Initials': 'CG', 'LastName': 'Mapari', 'Affiliation': 'Department of Anesthesiology, Victoria Hospital, Bangalore Medical College and Research Institute, Bangalore, India.'}]",Korean journal of anesthesiology,['10.4097/kja.d.19.00022']
107,31159533,Comparison of Air-QⓇ insertion techniques in pediatric patients with fiber-optic bronchoscopic assessment: a prospective randomized control trial.,"BACKGROUND


Air-QⓇ laryngeal mask airway (LMA) is a second-generation supraglottic airway device (SAD) providing adequate airway control despite the unfavorable airway anatomy in children. Several studies have assessed it as a conduit for tracheal intubation and compared its efficacy with that of other SADs, but there are no studies comparing the laryngeal view with midline and rotational insertion techniques of Air-Q. Therefore, this study compared the fiber-optic bronchoscopic (FOB) assessment of the Air-Q position using these two insertion techniques.
METHODS


This randomized controlled trial included 80 patients of the American Society of Anesthesiologists physical status I/II of either sex (age group 5-12 years, weight 10-30 kg), who were scheduled for elective surgery in the supine position under general anesthesia. The patients were randomly subjected to rotational and midline technique groups (n = 40, each), and appropriate sized Air-Q, based on the weight of the patient, was inserted using the technique allocated to each patient. Time taken and number of attempts for successful insertion of the devices and any complications after removal of device were studied.
RESULTS


FOB grade 1 (ideal position) was seen in 29/40 (72.5%) and 19/40 (47.5%) children subjected to the rotational and classic midline techniques, respectively (P = 0.045). The time taken to successfully insert the Air-Q was significantly lesser in the rotational technique group (7.2 ± 1.5 s) than in the classic midline technique group (10.2 ± 2.1 s) (P < 0.001), whereas complications were similar in both groups.
CONCLUSIONS


The rotational technique was associated with better FOB view, and was faster than the classic midline technique of Air-Q insertion in pediatric patients.",2019,Time taken to successfully insert the air Q was significantly less with the rotational technique [7.2 ± 1.5 sec] when compared with the classic midline technique [10.2 ± 2.1 sec] [P value <0.001].,"['paediatric patients', 'pediatric patients with fiberoptic bronchoscopic assessment', 'age group of 5 to 12 years, weighing 10 to 30 kilograms [kg] who were scheduled for elective surgery in supine position under general anaesthesia were included', '80 pediatric patients of American Society of Anesthesiologists [ASA] physical status']","['fiberoptic bronchoscopic [FOB', 'air Q® insertion techniques', '\n\n\nAir-QR Laryngeal mask airway [LMA']","['Complications', 'FOB Grade 1 [ideal position']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C0038846', 'cui_str': 'Dorsal Position'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}]",80.0,0.0728162,Time taken to successfully insert the air Q was significantly less with the rotational technique [7.2 ± 1.5 sec] when compared with the classic midline technique [10.2 ± 2.1 sec] [P value <0.001].,"[{'ForeName': 'Manasa', 'Initials': 'M', 'LastName': 'Gaddam', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Nehru Hospital, Chandigarh, India.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Sethi', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Nehru Hospital, Chandigarh, India.'}, {'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Jain', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Nehru Hospital, Chandigarh, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Saini', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Nehru Hospital, Chandigarh, India.'}]",Korean journal of anesthesiology,['10.4097/kja.d.18.00367']
108,32338624,A Mobile Health Solution Complementing Psychopharmacology-Supported Smoking Cessation: Randomized Controlled Trial.,"BACKGROUND


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


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


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


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


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


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


RR2-10.2196/12464.",2020,"In the IG, abstinence was 2.75 times higher (adjusted OR 3.45, P=.01) in the per-protocol analysis and 2.15 times higher (adjusted OR 3.13, P=.002) in the intention-to-treat analysis.","['A Mobile Health Solution Complementing Psychopharmacology-Supported Smoking Cessation', 'Virgen del Rocío University Hospital in Seville (Spain']","['control group (CG) receiving usual care (psychopharmacological treatment, n=120) or an intervention group (IG) receiving psychopharmacological treatment and using a mobile app providing artificial intelligence-generated and tailored smoking cessation support messages', 'mobile app supporting psychopharmacological therapy']","['health-related quality of life and monitor healthy lifestyle and physical exercise habits', 'system engagement']","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0009498', 'cui_str': 'Complement'}, {'cui': 'C0033929', 'cui_str': 'Psychopharmacology'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",,0.0824159,"In the IG, abstinence was 2.75 times higher (adjusted OR 3.45, P=.01) in the per-protocol analysis and 2.15 times higher (adjusted OR 3.13, P=.002) in the intention-to-treat analysis.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Carrasco-Hernandez', 'Affiliation': 'Smoking Cessation Unit, Medical-Surgical Unit of Respiratory Diseases, Virgen del Rocío University Hospital, Seville, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Jódar-Sánchez', 'Affiliation': 'Research and Innovation Group in Biomedical Informatics, Biomedical Engineering and Health Economy, Institute of Biomedicine of Seville, Virgen del Rocío University Hospital, Spanish National Research Council, University of Seville, Seville, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Núñez-Benjumea', 'Affiliation': 'Research and Innovation Group in Biomedical Informatics, Biomedical Engineering and Health Economy, Institute of Biomedicine of Seville, Virgen del Rocío University Hospital, Spanish National Research Council, University of Seville, Seville, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Moreno Conde', 'Affiliation': 'Research and Innovation Group in Biomedical Informatics, Biomedical Engineering and Health Economy, Institute of Biomedicine of Seville, Virgen del Rocío University Hospital, Spanish National Research Council, University of Seville, Seville, Spain.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Mesa González', 'Affiliation': 'Smoking Cessation Unit, Medical-Surgical Unit of Respiratory Diseases, Virgen del Rocío University Hospital, Seville, Spain.'}, {'ForeName': 'Antón', 'Initials': 'A', 'LastName': 'Civit-Balcells', 'Affiliation': 'Department of Architecture and Computer Technology, School of Computer Engineering, Universidad de Sevilla, Seville, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Hors-Fraile', 'Affiliation': 'Salumedia Labs, Seville, Spain.'}, {'ForeName': 'Carlos Luis', 'Initials': 'CL', 'LastName': 'Parra-Calderón', 'Affiliation': 'Research and Innovation Group in Biomedical Informatics, Biomedical Engineering and Health Economy, Institute of Biomedicine of Seville, Virgen del Rocío University Hospital, Spanish National Research Council, University of Seville, Seville, Spain.'}, {'ForeName': 'Panagiotis D', 'Initials': 'PD', 'LastName': 'Bamidis', 'Affiliation': 'Medical Physics Laboratory, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Ortega-Ruiz', 'Affiliation': 'Smoking Cessation Unit, Medical-Surgical Unit of Respiratory Diseases, Virgen del Rocío University Hospital, Seville, Spain.'}]",JMIR mHealth and uHealth,['10.2196/17530']
109,31369152,Nitrous oxide anesthetic versus total intravenous anesthesia for functional endoscopic sinus surgery.,"BACKGROUND


Functional endoscopic sinus surgery is a common procedure for sinonasal disease, frequently performed in the outpatient setting. General anesthesia maintained with total intravenous anesthesia (TIVA) with propofol has been shown to give superior surgical conditions compared to inhaled anesthetics. This study evaluated the effects of TIVA versus a predominantly nitrous oxide (N 2  O)-based anesthetic with a low-dose propofol and remifentanil infusion on sinus surgery.
METHODS


Patients were randomized to either a N 2  O-based (nitrous oxide with propofol and remifentanil) or TIVA (propofol and remifentanil without nitrous oxide) group. The surgeon was blinded to the anesthetic technique. Surgical field grading was performed in real time by the otolaryngologist every 15 minutes with the Boezaart grading system.
RESULTS


There were no statistically significant differences between the Boezaart scores, duration of surgery, or estimated blood loss between the two anesthetic techniques. However, the use of N 2  O provided a statistically significant, 38% reduction in time from surgery end to extubation. The TIVA group had significantly decreased mean and median pain scores in the post-anesthesia care unit (PACU). There was no difference in the rate of postoperative nausea and vomiting between the two groups.
CONCLUSION


A N 2  O-based anesthetic for functional endoscopic sinus surgery provides similar intraoperative and postoperative conditions when compared to TIVA, while being superior in terms of time to extubation. Although the TIVA group had significantly decreased pain scores, this did not lead to a decrease in pain medicine received in the PACU, and there was no difference between groups in time to discharge.
LEVEL OF EVIDENCE


1b Laryngoscope, 130:E299-E304, 2020.",2020,"There were no statistically significant differences between the Boezaart scores, duration of surgery, or estimated blood loss between the two anesthetic techniques.","['Patients', 'functional endoscopic sinus surgery']","['General anesthesia maintained with total intravenous anesthesia (TIVA) with propofol', 'Functional endoscopic sinus surgery', 'Nitrous oxide anesthetic versus total intravenous anesthesia', 'N 2  O-based (nitrous oxide with propofol and remifentanil) or TIVA (propofol and remifentanil without nitrous oxide', 'TIVA', 'nitrous oxide (N 2  O)-based anesthetic with a low-dose propofol and remifentanil infusion']","['rate of postoperative nausea and vomiting', 'time to discharge', 'mean and median pain scores', 'pain medicine', 'Boezaart scores, duration of surgery, or estimated blood loss', 'pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery (qualifier value)'}]","[{'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia (procedure)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery (qualifier value)'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C3854651', 'cui_str': 'TIVA'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}]",,0.0364695,"There were no statistically significant differences between the Boezaart scores, duration of surgery, or estimated blood loss between the two anesthetic techniques.","[{'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Heller', 'Affiliation': 'The Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'DeMaria', 'Affiliation': 'The Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}, {'ForeName': 'Erick', 'Initials': 'E', 'LastName': 'Mendoza', 'Affiliation': 'The Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Hyman', 'Affiliation': 'The Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}, {'ForeName': 'Alfred M C', 'Initials': 'AMC', 'LastName': 'Iloreta', 'Affiliation': 'The Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}, {'ForeName': 'Hung-Mo', 'Initials': 'HM', 'LastName': 'Lin', 'Affiliation': 'The Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Govindaraj', 'Affiliation': 'The Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}, {'ForeName': 'Adam I', 'Initials': 'AI', 'LastName': 'Levine', 'Affiliation': 'The Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}]",The Laryngoscope,['10.1002/lary.28201']
110,31385620,Voice-Related Quality of Life Increases With a Talking Tracheostomy Tube: A Randomized Controlled Trial.,"OBJECTIVE


The primary objective of our study was to determine the quality of life (QOL) using a talking tracheostomy tube.
METHODS


Randomized clinical trial (NCT2018562). Adult intensive care unit patients who were mechanically ventilated, awake, alert, attempting to communicate, English-speaking, and could not tolerate one-way speaking valve were included. Intervention comprised a Blue Line Ultra Suctionaid (BLUSA) talking tracheostomy tube (Smiths Medical, Dublin, OH, US). Outcome measures included QOL scores measured using Quality of Life in Mechanically Ventilated Patients (QOL-MV) and Voice-Related Quality of Life (V-RQOL), Speech Intelligibility Test (SIT) scores, independence, and satisfaction.
RESULTS


The change in V-RQOL scores from pre- to postintervention was higher among patients using a BLUSA (Smiths Medical) compared to those who did not (P = 0.001). The QOL-MV scores from pre- to postintervention were significantly higher among patients who used a BLUSA (Smiths Medical) compared to patients who did not use BLUSA (Smiths Medical) or a one-way speaking valve (P = 0.04). SIT scores decreased by 6.4 points for each 1-point increase in their Sequential Organ Failure Assessment scores (P = 0.04). The overall QOL-MV scores correlated moderately with the overall V-RQOL scores (correlation coefficient = 0.59). Cronbach alpha score for overall QOL-MV was 0.71. Seventy-three percent of the 22 intervention patients reported the ability to use the BLUSA (Smiths Medical) with some level of independence, whereas 41% reported some level of satisfaction with the use of BLUSA (Smiths Medical). The lengths of stay was longer in the intervention group.
CONCLUSION


Our study suggests that BLUSA (Smiths Medical) talking tracheostomy tube improves patient-reported QOL in mechanically ventilated patients with a tracheostomy who cannot tolerate cuff deflation.
LEVEL OF EVIDENCE


I Laryngoscope, 130:1249-1255, 2020.",2020,The QOL-MV scores from pre- to postintervention were significantly higher among patients who used a BLUSA (Smiths Medical) compared to patients who did not use BLUSA (Smiths Medical) or a one-way speaking valve (P = 0.04).,"['mechanically ventilated patients with a tracheostomy who cannot tolerate cuff deflation', 'Adult intensive care unit patients who were mechanically ventilated, awake, alert, attempting to communicate, English-speaking, and could not tolerate one-way speaking valve were included']","['BLUSA (Smiths Medical) talking tracheostomy tube', 'talking tracheostomy tube', 'Blue Line Ultra Suctionaid (BLUSA) talking tracheostomy tube']","['SIT scores', 'Cronbach alpha score for overall QOL-MV', 'Sequential Organ Failure Assessment scores', 'lengths of stay', 'ability to use the BLUSA', 'QOL-MV scores', 'overall QOL-MV scores', 'quality of life (QOL', 'change in V-RQOL scores', 'QOL scores measured using Quality of Life in Mechanically Ventilated Patients (QOL-MV) and Voice-Related Quality of Life (V-RQOL), Speech Intelligibility Test (SIT) scores, independence, and satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0587445', 'cui_str': 'Adult intensive care unit (environment)'}, {'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C0566001', 'cui_str': 'Does communicate (finding)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0554249', 'cui_str': 'Smith (occupation)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0184159', 'cui_str': 'Tracheostomy tube'}, {'cui': 'C1260957', 'cui_str': 'Blue color (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3494459', 'cui_str': 'SOFAS Scores'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0034380'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0725424,The QOL-MV scores from pre- to postintervention were significantly higher among patients who used a BLUSA (Smiths Medical) compared to patients who did not use BLUSA (Smiths Medical) or a one-way speaking valve (P = 0.04).,"[{'ForeName': 'Vinciya', 'Initials': 'V', 'LastName': 'Pandian', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, Maryland, U.S.A.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Cole', 'Affiliation': 'The Johns Hopkins Hospital, Baltimore, Maryland, U.S.A.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Kilonsky', 'Affiliation': 'The Johns Hopkins Hospital, Baltimore, Maryland, U.S.A.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Holden', 'Affiliation': 'The Johns Hopkins Hospital, Baltimore, Maryland, U.S.A.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Feller-Kopman', 'Affiliation': 'The Johns Hopkins Hospital, Baltimore, Maryland, U.S.A.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Brower', 'Affiliation': 'The Johns Hopkins Hospital, Baltimore, Maryland, U.S.A.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Mirski', 'Affiliation': 'The Johns Hopkins Hospital, Baltimore, Maryland, U.S.A.'}]",The Laryngoscope,['10.1002/lary.28211']
111,31159537,Ultrasound-guided greater occipital nerve block with botulinum toxin for patients with chronic headache in the occipital area: a randomized controlled trial.,"BACKGROUND


Ultrasound-guided greater occipital nerve (GON) block has been frequently used to treat various types of headaches, and botulinum toxin has recently begun to be used in patients with headache. Our study presents the long-term effect of botulinum toxin on GON block using ultrasound in patients with chronic headache in occipital area.
METHODS


Patients with occipital headache were divided into two groups (bupivacaine: BUP group [n = 27], botulinum toxin: BTX group [n = 27]), and ultrasound-guided GON block was performed at the C2 level. GON was detected with ultrasound and distance from GON to midline, from the skin surface to GON, and size of GON were measured in both groups. Visual analogue scale (VAS) scores and Likert scale were assessed at pretreatment and at 1, 4, 8, and 24 weeks after treatment in both groups.
RESULTS


The distance from GON to midline was 18.9 ± 4.4 mm (right) and 17.3 ± 3.8 mm (left). The depth from the skin was 12.9 ± 1.5 mm (right) and 13.4 ± 1.6 mm (left). GON size was 3.1 mm on both sides. The VAS score and patient satisfaction score (Likert scale) in 4, 8, and 24 weeks after injection were superior for the BTX than the BUP group.
CONCLUSIONS


Ultrasound-guided GON block using BTX is effective in reducing short-term and long-term pain in patients with chronic headache in the occipital area.",2019,"Conclusions


Ultrasound-guided GON block using botulinum toxin is effective in reducing short-term and long-term pain in patients with chronic headache in occipital area.","['patients with chronic headache in the occipital area', 'Patients with occipital headache', 'patients with chronic headache in occipital area', 'patients with headache']","['botulinum toxin: group BTX', 'botulinum toxin', 'Ultrasound-guided greater occipital nerve block with botulinum toxin', 'ultrasound-guided GON block', 'ultrasound guided greater occipital nerve (GON) block', 'bupivacaine: group BUP']","['VAS scores and Likert scale', 'VAS score and patient satisfaction score (Likert scale', 'size of GON']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0151293', 'cui_str': 'Chronic Headache'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0231613', 'cui_str': 'Occipital headache (finding)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}]","[{'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0394692', 'cui_str': 'Injection of anesthetic agent into greater occipital nerve (procedure)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score (assessment scale)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]",,0.0372216,"Conclusions


Ultrasound-guided GON block using botulinum toxin is effective in reducing short-term and long-term pain in patients with chronic headache in occipital area.","[{'ForeName': 'Jae Hyung', 'Initials': 'JH', 'LastName': 'Ryu', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Guri Hospital, Hanyang University College of Medicine, Guri, Korea.'}, {'ForeName': 'Jae Hang', 'Initials': 'JH', 'LastName': 'Shim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Guri Hospital, Hanyang University College of Medicine, Guri, Korea.'}, {'ForeName': 'Jong Hoon', 'Initials': 'JH', 'LastName': 'Yeom', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Guri Hospital, Hanyang University College of Medicine, Guri, Korea.'}, {'ForeName': 'Woo Jong', 'Initials': 'WJ', 'LastName': 'Shin', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Guri Hospital, Hanyang University College of Medicine, Guri, Korea.'}, {'ForeName': 'Sang Yun', 'Initials': 'SY', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Guri Hospital, Hanyang University College of Medicine, Guri, Korea.'}, {'ForeName': 'Woo Jae', 'Initials': 'WJ', 'LastName': 'Jeon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Guri Hospital, Hanyang University College of Medicine, Guri, Korea.'}]",Korean journal of anesthesiology,['10.4097/kja.19145']
112,31216846,Programmed intermittent epidural bolus as compared to continuous epidural infusion for the maintenance of labor analgesia: a prospective randomized single-blinded controlled trial.,"BACKGROUND


Programmed intermittent epidural bolus (PIEB) techniques are a new area of interest for maintaining labor analgesia due to the potential to decrease motor block and improve labor analgesia. This study compares continuous epidural infusion (CEI) to 2 PIEB regimens for labor analgesia.
METHODS


One hundred fifty patients undergoing scheduled induction of labor at term gestation having epidural labor analgesia were randomized to receive an epidural analgesia regimen of bupivacaine 0.125% with fentanyl 2 μg/ml at either PIEB 5 ml every 30 min (Group 5q30), PIEB 10 ml every 60 min (Group 10q60), or 10 ml/h continuous infusion (Group continuous epidural infusion [CEI]). The primary outcome is the pain scores throughout labor. Secondary outcomes include degree of motor block, dermatomal sensory levels, the number of physician-administered boluses, and patient satisfaction.
RESULTS


While the average pain scores throughout labor did not differ significantly between groups, fewer patients in group 10q60 received physician-administered boluses for breakthrough pain (34.9% in 10q60 vs. 61.0% in 5q30 and 61.9% in CEI, P = 0.022). Dermatomal sensory levels, degree of motor block, and patient satisfaction did not differ significantly between groups.
CONCLUSIONS


Our study suggests that high volume PIEB regimens for labor analgesia decrease breakthrough pain and physician-administered boluses.",2019,"Dermatomal sensory levels, degree of motor block, and patient satisfaction did not differ significantly between groups.
",['150 patients undergoing scheduled induction of labor at term gestation having epidural labor analgesia'],"['epidural analgesia regimen of bupivacaine 0.125% with fentanyl 2 mcg/mL at either PIEB 5 mL', 'continuous epidural infusion (CEI', 'Programmed intermittent epidural bolus (PIEB', 'PIEB 10 mL']","['pain scores throughout labor', 'Dermatomal sensory levels, degree of motor block, and patient satisfaction', 'number of physician administered boluses, dermatomal sensory levels, degree of motor block, and patient satisfaction', 'breakthrough pain', 'average pain scores throughout labor']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0259787', 'cui_str': 'Labor Induction'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C4517427', 'cui_str': '0.125 (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C1262068', 'cui_str': 'Sensory level'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1135120', 'cui_str': 'Breakthrough Pain'}]",150.0,0.185858,"Dermatomal sensory levels, degree of motor block, and patient satisfaction did not differ significantly between groups.
","[{'ForeName': 'Christina W', 'Initials': 'CW', 'LastName': 'Fidkowski', 'Affiliation': 'Department of Anesthesiology, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Sonalee', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Department of Anesthesiology, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Mohamed-Rida', 'Initials': 'MR', 'LastName': 'Alsaden', 'Affiliation': 'Department of Anesthesiology, Henry Ford Hospital, Detroit, MI, USA.'}]",Korean journal of anesthesiology,['10.4097/kja.19156']
113,31426623,Comparison of clinical performance of i-gelⓇ and Baska MaskⓇ during laparoscopic cholecystectomy.,"BACKGROUND


The supraglottic airway device is an appropriate alternative to tracheal intubation in laparoscopic surgery. We compared the Baska MaskⓇ with i-gelⓇ by measuring the oropharyngeal leak pressure (OLP) and hemodynamic and respiratory parameters during laparoscopic cholecystectomy.
METHODS


A total of 97 patients were randomly allocated to either i-gel group (n = 49) or Baska Mask group (n = 48). Insertion time, number of insertion attempts, fiber-optic view of the glottis, and OLP were recorded. Heart rate, mean arterial pressure, peak airway pressure (PAP), lung compliance, and perioperative complications were assessed before, during, and after pneumoperitoneum.
RESULTS


There were no significant differences between the two groups regarding demographic data, insertion time, fiber-optic view of the glottis, and the use of airway manipulation. The OLP was higher in the Baska Mask group than in the i-gel group (29.6 ± 6.8 cmH2O and 26.7 ± 4.5 cmH2O, respectively; P = 0.014). Heart rate, mean arterial pressure, PAP, and lung compliance were not significantly different between the groups. The incidence of perioperative complications was small and not statistically significant.
CONCLUSIONS


Both the i-gel and Baska Mask provided a satisfactory airway during laparoscopic cholecystectomy. Compared with the i-gel, the Baska Mask demonstrated a higher OLP.",2019,"There were no significant differences between the two groups regarding demographic data, insertion time, fiber-optic view of the glottis, and the use of airway manipulation.","['97 patients', 'laparoscopic cholecystectomy']","['I-gel® and Baska Mask®', 'Baska Mask with I-gel', 'Baska Mask']","['Insertion time, number of insertion attempts, fiber-optic view of the glottis, and OLP', 'incidence of perioperative complications', 'Heart rate, mean arterial pressure, PAP, and lung compliance', 'oropharyngeal leak pressure (OLP) and hemodynamic and respiratory parameters', 'OLP', 'demographic data, insertion time, fiber-optic view of the glottis, and the use of airway manipulation', 'Heart rate, mean arterial pressure, peak airway pressure (PAP), lung compliance, and perioperative complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]","[{'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}]","[{'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure (body structure)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0024112', 'cui_str': 'Lung Compliance'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0332234', 'cui_str': 'Leaking (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}]",97.0,0.0525631,"There were no significant differences between the two groups regarding demographic data, insertion time, fiber-optic view of the glottis, and the use of airway manipulation.","[{'ForeName': 'So Ron', 'Initials': 'SR', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Tae Young', 'Initials': 'TY', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Sung Wan', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Sang Yoong', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Chan Jong', 'Initials': 'CJ', 'LastName': 'Chung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Jeong Ho', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Dong-A University College of Medicine, Busan, Korea.'}]",Korean journal of anesthesiology,['10.4097/kja.19195']
114,32145674,"A double-blind, randomized, sham-controlled study of cranial electrotherapy stimulation as an add-on treatment for tic disorders in children and adolescents.","AIM


The aim of this study was to determine the efficacy and safety of cranial electrotherapy stimulation (CES) as an add-on treatment for TD.
METHODS


A randomized, double-blind, sham-controlled trial was conducted at an outpatient, single-center academic setting. A total of 62 patients aged 6-17 years with TD and lack of clinical response to 4 weeks' pharmacotherapy were enrolled. Patients were divided randomly into 2 groups and given 4 weeks' treatment, including 30 min sessions of active CES (500 μA-2 mA) or sham CES (lower than 100 μA) per day for 40 d on weekdays. Change in Yale Global Tic Severity Scale (YGTSS), Clinical Global Impression-severity of illness-severity (CGI-S) and Hamilton Anxiety Scale-14 items (HAMA-14) were performed at baseline, week 2, week 4. Adverse events (AEs) were also evaluated.
RESULTS


53 patients (34 males and 9 females) completed the trial, including 29 in the active CES group and 24 in the sham CES group. Both groups showed clinical improvement in tic severities compared to baseline respectively at week 4. Participants receiving active CES showed a reduction of 31.66 % in YGTSS score, compared with 23.96 % in participants in sham CES group, resulting in no significant difference between the two groups (t = 1.54, p = 0.13).
CONCLUSION


Four-week's treatment of CES for children and adolescents with TD is effective and safe, but the improvement for tic severity may be related to placebo effect.",2020,"Participants receiving active CES showed a reduction of 31.66 % in YGTSS score, compared with 23.96 % in participants in sham CES group, resulting in no significant difference between the two groups (t = 1.54, p = 0.13).
","[""62 patients aged 6-17 years with TD and lack of clinical response to 4 weeks' pharmacotherapy were enrolled"", 'tic disorders in children and adolescents', '53 patients (34 males and 9 females) completed the trial, including 29 in the active CES group and 24 in the sham CES group']","['cranial electrotherapy stimulation', 'active CES', 'cranial electrotherapy stimulation (CES', 'active CES (500\u2009μA-2\u2009mA) or sham CES']","['clinical improvement in tic severities', 'Yale Global Tic Severity Scale (YGTSS), Clinical Global Impression-severity of illness-severity (CGI-S) and Hamilton Anxiety', 'efficacy and safety', 'Adverse events (AEs', 'YGTSS score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder (disorder)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C3163632', 'cui_str': 'Cranial'}, {'cui': 'C0013787', 'cui_str': 'Electrical Stimulation Therapy'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0278076', 'cui_str': 'Habit Chorea'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C4720888', 'cui_str': 'Yale global tic severity scale (assessment scale)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",62.0,0.38816,"Participants receiving active CES showed a reduction of 31.66 % in YGTSS score, compared with 23.96 % in participants in sham CES group, resulting in no significant difference between the two groups (t = 1.54, p = 0.13).
","[{'ForeName': 'Wen-Jun', 'Initials': 'WJ', 'LastName': 'Wu', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: wenjun104@126.com.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: fgx995@163.com.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Cai', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: caimin@fmmu.edu.cn.""}, {'ForeName': 'Yi-Huan', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: 182368179@qq.com.""}, {'ForeName': 'Cui-Hong', 'Initials': 'CH', 'LastName': 'Zhou', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: zch4610@126.com.""}, {'ForeName': 'Hua-Ning', 'Initials': 'HN', 'LastName': 'Wang', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: xskzhu@fmmu.edu.cn.""}, {'ForeName': 'Long-Biao', 'Initials': 'LB', 'LastName': 'Cui', 'Affiliation': ""Department of Clinical Psychology, School of Medical Psychology, Fourth Military Medical University, 169 # West Changle Road, Xi'an, 710032, China. Electronic address: lbcui@fmmu.edu.cn.""}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.101992']
115,32317236,Adaptive servo-ventilation therapy does not favourably alter sympatho-vagal balance in sleeping patients with systolic heart failure and central apnoeas: Preliminary data.,"BACKGROUND


In contrast to continuous positive airway pressure (CPAP), the use of adaptive servo-ventilation (ASV) for treatment of central sleep apnoea (CSA) was associated with increased mortality in patients with chronic systolic heart failure (CHF). In order to characterize the interplay between sleep-disordered breathing, CHF and sympathovagal balance (SVB) this study investigated the effect of nocturnal CPAP and ASV on SVB in CSA patients with or without CHF.
METHODS


Thirty-seven patients with ongoing positive airway pressure therapy (CPAP or ASV) for CSA (17 patients with systolic CHF - left ventricular ejection fraction <50% - and 20 patients with CSA but no CHF) underwent evaluation of SVB (spectral analysis of heart rate -HRV- and diastolic blood pressure variability) during full nocturnal polysomnography. The night was randomly split into equal parts including no treatment (NT), automatic CPAP and ASV. Data analysis was restricted to stable N2 sleep.
RESULTS


In patients with CSA and systolic CHF, neither automatic CPAP nor ASV showed favourable effects on parameters reflecting SVB during N2 sleep (all p > 0.05). In contrast, in subjects with CSA without CHF automatic CPAP, but not ASV, favourably altered SVB by decreasing the low frequency and increasing the high frequency component of HRV (both p = 0.03).
CONCLUSIONS


Effects of various modes of positive airway pressure therapy of CSA on SVB during sleep depend on the mode of pressure support and underlying cardiac function. Automatic CPAP but not ASV favourably influences SVB in subjects without CHF, whereas both interventions leave SVB unchanged in patients with CHF.",2020,"In patients with CSA and systolic CHF, neither automatic CPAP nor ASV showed favourable effects on parameters reflecting SVB during N2 sleep (all p > 0.05).","['patients with chronic systolic heart failure (CHF', 'CSA patients with or without CHF', 'Thirty-seven patients with ongoing positive airway pressure therapy (CPAP or ASV) for CSA (17 patients with systolic CHF - left ventricular ejection fraction <50% - and 20 patients with CSA but no CHF) underwent evaluation of SVB (spectral analysis of heart rate -HRV- and diastolic blood pressure variability) during full nocturnal polysomnography', 'central sleep apnoea (CSA', 'sleeping patients with systolic heart failure and central apnoeas']","['continuous positive airway pressure (CPAP', 'Adaptive servo-ventilation therapy', 'adaptive servo-ventilation (ASV', 'nocturnal CPAP and ASV', 'CSA', 'randomly split into equal parts including no treatment (NT), automatic CPAP and ASV']",['sympatho-vagal balance'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1135194', 'cui_str': 'Chronic systolic heart failure'}, {'cui': 'C0520680', 'cui_str': 'Apnea, Central Sleep'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C4285752', 'cui_str': 'Adaptive servo-ventilation'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1135191', 'cui_str': 'Systolic heart failure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C4285752', 'cui_str': 'Adaptive servo-ventilation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0520680', 'cui_str': 'Apnea, Central Sleep'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205554', 'cui_str': 'Automated'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",37.0,0.0143315,"In patients with CSA and systolic CHF, neither automatic CPAP nor ASV showed favourable effects on parameters reflecting SVB during N2 sleep (all p > 0.05).","[{'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Gorbachevski', 'Affiliation': 'Department of Neurology with Institute for Translational Neurology, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Spiesshoefer', 'Affiliation': ""Department of Neurology with Institute for Translational Neurology, University Hospital Muenster, Muenster, Germany; Institute of Life Sciences, Scuola Superiore Sant'Anna, Pisa, Italy. Electronic address: jens.spiesshoefer@ukmuenster.de.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Arzt', 'Affiliation': 'Department of Internal Medicine II, University Medical Center Regensburg, Regensburg, Germany.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Oldenburg', 'Affiliation': 'Ludgerus-Kliniken Münster, Clemenshospital, Münster, Germany.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Becker', 'Affiliation': 'Department of Neurology with Institute for Translational Neurology, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Izabela', 'Initials': 'I', 'LastName': 'Tuleta', 'Affiliation': 'Department of Cardiology I, University Hospital of Muenster, Muenster, Germany.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Emdin', 'Affiliation': ""Institute of Life Sciences, Scuola Superiore Sant'Anna, Pisa, Italy; Cardiology and Cardiovascular Medicine Division, Fondazione Toscana Gabriele Monasterio, National Research Council, CNR-Regione Toscana, Pisa, Italy.""}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Passino', 'Affiliation': ""Institute of Life Sciences, Scuola Superiore Sant'Anna, Pisa, Italy; Cardiology and Cardiovascular Medicine Division, Fondazione Toscana Gabriele Monasterio, National Research Council, CNR-Regione Toscana, Pisa, Italy.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Sciarrone', 'Affiliation': 'Cardiology and Cardiovascular Medicine Division, Fondazione Toscana Gabriele Monasterio, National Research Council, CNR-Regione Toscana, Pisa, Italy.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Boentert', 'Affiliation': 'Department of Neurology with Institute for Translational Neurology, University Hospital Muenster, Muenster, Germany; Department of Medicine, UKM Marienhospital Steinfurt, Steinfurt, Germany.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Giannoni', 'Affiliation': ""Institute of Life Sciences, Scuola Superiore Sant'Anna, Pisa, Italy; Cardiology and Cardiovascular Medicine Division, Fondazione Toscana Gabriele Monasterio, National Research Council, CNR-Regione Toscana, Pisa, Italy.""}]",International journal of cardiology,['10.1016/j.ijcard.2020.03.078']
116,32330594,Pilot study of combined aerobic and resistance exercise on fatigue for patients with head and neck cancer: Inflammatory and epigenetic changes.,"This pilot study examined whether a combined aerobic resistance exercise program reduced fatigue and the potential inflammatory and epigenetic mechanisms in patients with head and neck cancer (HNC) receiving intensity-modulated radiotherapy. The exercise group (N = 12) received a 3-month supervised aerobic resistance exercise intervention that was initiated before a 6-week radiotherapy regimen; the control group (N = 14) received standard care. Fatigue was measured using Multidimensional Fatigue Inventory-20; physical function measures included a 6-minute walk distance (6MWD), chair stands, bicep curls, and hand grip strength. Inflammatory markers and DNA methylation data were acquired using standardized protocol. Patients were mostly white (93%) and male (81%) with a mean age of 57 years. At the end of the intervention, the exercise group had a marginal decrease in fatigue compared with the control (-5.0 vs. 4.9; P = 0.10). The exercise group had a significantly greater improvement in 6MWD (29.8 vs. -55.5 m; P = 0.04), and a marginally smaller decline in hand grip (-0.3 vs. -5.8 lbs; P = 0.05) at the end of the intervention than the control. No significant difference in inflammatory markers was observed between groups. Lower plasma interleukin (IL) 6, IL1 receptor antagonist, tumor necrosis factor α (TNFα), soluble TNF receptor II and C-reactive protein were significantly associated with increased 6MWD, chair stand, and bicep curl at the end of the intervention (p < 0.05). Among the 1152 differentially methylated sites (DMS) after intervention (p < 0.001), 163 DMS were located in gene promoter regions. Enrichment analysis suggested that the top 10 upstream regulators were associated with tumor (HNF4A, RPP38, HOXA9, SAHM1, CDK7, NDN, RPS15) and inflammation (IRF7, CRKL, ONECUT1). The top 5 diseases or functions annotations of the 62 hypermethylated DMS indicated anti-tumor and anti-inflammatory effects that might be linked to exercise. These findings suggest that exercise may improve physical performance and reduce fatigue, which could be further linked to decreased inflammation, during active radiotherapy for HNC patients. Larger studies are warranted.",2020,"Lower plasma interleukin (IL) 6, IL1 receptor antagonist, tumor necrosis factor α (TNFα), soluble TNF receptor II and C-reactive protein were significantly associated with increased 6MWD, chair stand, and bicep curl at the end of the intervention (p<0.05).","['Patients were mostly white (93%) and male (81%) with a mean age of 57 years', 'Patients with Head and Neck Cancer', 'patients with head and neck cancer (HNC) receiving intensity-modulated radiotherapy']","['supervised aerobic resistance exercise intervention', 'Combined Aerobic and Resistance Exercise', 'combined aerobic resistance exercise program', 'standard care']","['6MWD, chair stand, and bicep curl', '6-minute walk distance (6MWD), chair stands, bicep curls, and hand grip strength', 'inflammatory markers', 'Lower plasma interleukin (IL) 6, IL1 receptor antagonist, tumor necrosis factor α (TNFα), soluble TNF receptor II and C-reactive protein', 'fatigue and the potential inflammatory and epigenetic mechanisms', 'Fatigue', '6MWD', 'physical performance and reduce fatigue', 'fatigue', 'tumor (HNF4A, RPP38, HOXA9, SAHM1, CDK7, NDN, RPS15) and inflammation (IRF7, CRKL, ONECUT1']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0063710', 'cui_str': 'Interleukin 1 Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0077503', 'cui_str': 'Tumor Necrosis Factor Receptor'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1516924', 'cui_str': 'Epigenetic Process'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0386322', 'cui_str': 'Hoxa9 protein'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1530281', 'cui_str': 'IRF7 protein, human'}, {'cui': 'C0219488', 'cui_str': 'CRKL protein'}]",163.0,0.0291941,"Lower plasma interleukin (IL) 6, IL1 receptor antagonist, tumor necrosis factor α (TNFα), soluble TNF receptor II and C-reactive protein were significantly associated with increased 6MWD, chair stand, and bicep curl at the end of the intervention (p<0.05).","[{'ForeName': 'Canhua', 'Initials': 'C', 'LastName': 'Xiao', 'Affiliation': 'School of Nursing, Yale University, 400 West Campus Drive, Orange 06477, United States. Electronic address: canhua.xiao@yale.edu.'}, {'ForeName': 'Jonathan J', 'Initials': 'JJ', 'LastName': 'Beitler', 'Affiliation': 'Department of Radiation, School of Medicine, Emory University, 1520 Clifton Road NE, Atlanta 30322, United States.'}, {'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Higgins', 'Affiliation': 'Department of Radiation, School of Medicine, Emory University, 1520 Clifton Road NE, Atlanta 30322, United States.'}, {'ForeName': 'Cynthia E', 'Initials': 'CE', 'LastName': 'Chico', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, 1365-B Clifton Road, Atlanta, GA 30322, United States.'}, {'ForeName': 'Janice S', 'Initials': 'JS', 'LastName': 'Withycombe', 'Affiliation': ""School of Nursing, Clemson University, 508 Edward's, Clemson, SC 29634, United States.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'State Key Laboratory of Medical Neurobiology and MOE Frontier Center for Brain Science, Institutes of Brain Science, Fudan University, Shanghai 200433, China.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Epidemiology and Public Health, School of Medicine, Yale University, 300 George Street, New Haven, CT 06510, United States.'}, {'ForeName': 'I-Hsin', 'Initials': 'IH', 'LastName': 'Lin', 'Affiliation': 'Yale Center for Analytical Sciences, School of Public Health, Yale University, 300 George Street, New Haven, CT 06510, United States.'}, {'ForeName': 'Fangyong', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'School of Public Health, Yale University, 60 College St, New Haven, CT 06510, United States.'}, {'ForeName': 'Sangchoon', 'Initials': 'S', 'LastName': 'Jeon', 'Affiliation': 'School of Nursing, Yale University, 400 West Campus Drive, Orange 06477, United States.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Irwin', 'Affiliation': 'School of Public Health, Yale University, 60 College St, New Haven, CT 06510, United States.'}, {'ForeName': 'Deborah W', 'Initials': 'DW', 'LastName': 'Bruner', 'Affiliation': 'School of Nursing, Emory University, 1520 Clifton Road NE, Atlanta 30322, United States.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Miller', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, 1365-B Clifton Road, Atlanta, GA 30322, United States.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Gary', 'Affiliation': 'School of Nursing, Emory University, 1520 Clifton Road NE, Atlanta 30322, United States.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2020.04.044']
117,32305531,Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS) procedure for colorectal liver metastasis.,"Since first described, Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS) has garnered boisterous praise and fervent criticism. Its rapid adoption and employment for a variety of indications resulted in high perioperative morbidity and mortality. However recent risk stratification, refinement of technique to reduce the impact of stage I and progression along the learning curve have resulted in improved outcomes. The first randomized trial comparing ALPPS to two stage hepatectomy (TSH) for colorectal liver metastases (CRLM) was recently published demonstrating comparable perioperative morbidity and mortality with improved resectability and survival following ALPPS. In this review, as ALPPS enters the thirteenth year since conception, the current status of this contentious two stage technique is presented and best practices for deployment in the treatment of CRLM is codified.",2020,The first randomized trial comparing ALPPS to two stage hepatectomy (TSH) for colorectal liver metastases (CRLM) was recently published demonstrating comparable perioperative morbidity and mortality with improved resectability following ALPPS.,['colorectal liver metastases (CRLM'],"['Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS', 'stage hepatectomy (TSH', 'ALPPS', 'Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS) Procedure']",[],"[{'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}]","[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0032718', 'cui_str': 'Portal vein structure'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0301811', 'cui_str': 'Alkaline phosphatase isoenzyme, placental fraction'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],,0.0558555,The first randomized trial comparing ALPPS to two stage hepatectomy (TSH) for colorectal liver metastases (CRLM) was recently published demonstrating comparable perioperative morbidity and mortality with improved resectability following ALPPS.,"[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Hernandez-Alejandro', 'Affiliation': 'Department of Surgery and Division of Abdominal Transplantation and Hepatobiliary Surgery, University of Rochester Medical Center, Rochester, USA. Electronic address: Roberto_Hernandez@urmc.rochester.edu.'}, {'ForeName': 'Luis I', 'Initials': 'LI', 'LastName': 'Ruffolo', 'Affiliation': 'Department of Surgery and Division of Abdominal Transplantation and Hepatobiliary Surgery, University of Rochester Medical Center, Rochester, USA.'}, {'ForeName': 'Ruslan', 'Initials': 'R', 'LastName': 'Alikhanov', 'Affiliation': 'Department of Liver and Pancreatic Surgery, Clinical Research Center of Moscow, Moscow, Russia.'}, {'ForeName': 'Bergthor', 'Initials': 'B', 'LastName': 'Björnsson', 'Affiliation': 'Department of Surgery in Linköping, And Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Orlando Jorge M', 'Initials': 'OJM', 'LastName': 'Torres', 'Affiliation': 'Department of Gastrointestinal Surgery, Hepatopancreatobiliary Unit, University Hospital and School of Medicine, Federal University of Maranhão, São Luís, Brazil.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Serrablo', 'Affiliation': 'Division of Surgery, Miguel Servet University Hospital and University of Zaragoza School of Medicine, Zaragoza, Spain.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.04.009']
118,32329778,Efficacy of Supporting Play Exploration and Early Development Intervention in the First Months of Life for Infants Born Very Preterm: 3-Arm Randomized Clinical Trial Protocol.,"OBJECTIVE


The aim of this project is to study the effect of a physical therapist intervention provided in the first months of life on developmental outcomes of infants born very preterm. Secondary aims are to investigate the impact of intervention timing on the efficacy and impact of the intervention on infants with and without cerebral palsy.
METHODS


This study is a multisite longitudinal controlled trial comparing developmental outcomes from infants in the Supporting Play, Exploration, and Early Development Intervention (SPEEDI)_Late or SPEEDI_Early group to a usual care group.
SETTINGS ARE URBAN


Urban and rural areas surrounding 2 academic medical centers. There will be 90 preterm infants enrolled in this study born at <29 weeks of gestation. SPEEDI is a developmental intervention provided by collaboration between a physical therapist and parent to support a child's motor and cognitive development. The primary outcome measure is the Bayley Scale of Infant and Toddler Development Cognitive and Gross Motor Scaled Scores. Secondary measures include behavioral coding of early problem solving skills, the Gross Motor Function Measure, and Test of Infant Motor Performance.
IMPACT


More than 270,000 infants are born very preterm in the United States each year, 50% of whom will have neurological dysfunction that limits their ability to keep pace with peers who are typically developing. This study is a step toward understanding the impact that intensive developmental intervention could have in this population in the first months of life.",2020,"This study is a multisite longitudinal controlled trial comparing developmental outcomes from infants in the SPEEDI_Late or SPEEDI_Early group to a usual care group.
","['Infants Born Very Preterm', 'infants with and without cerebral palsy', 'Urban and rural areas surrounding 2 academic medical centers', 'infants in the SPEEDI_Late or SPEEDI_Early group to a usual care group', '90 preterm infants enrolled in this study born at <\u200929\xa0weeks of gestation', 'infants born very preterm']","['intensive developmental intervention', 'Supporting Play Exploration and Early Development Intervention (SPEEDI', 'physical therapy intervention']","['behavioral coding of early problem solving skills, the Gross Motor Function Measure (GMFM), and Test of Infant Motor Performance (TIMP', 'Bayley Scale of Infant and Toddler Development Cognitive and Gross Motor Scaled Scores']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1282914', 'cui_str': 'Circumscribed'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",90.0,0.0501801,"This study is a multisite longitudinal controlled trial comparing developmental outcomes from infants in the SPEEDI_Late or SPEEDI_Early group to a usual care group.
","[{'ForeName': 'Stacey C', 'Initials': 'SC', 'LastName': 'Dusing', 'Affiliation': 'Biokinesiology and Physical Therapy, University of Southern California, 1540 E Alcazar St, CHP 155, Los Angeles, CA 90033 (USA).'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Burnsed', 'Affiliation': 'Department of Pediatrics and Neurology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Shaaron E', 'Initials': 'SE', 'LastName': 'Brown', 'Affiliation': 'Board Certified Pediatric Specialist, Department of Physical Therapy, Virginia Commonwealth University Health, Richmond, Virginia.'}, {'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'Harper', 'Affiliation': 'Department of Neurology, Virginia Commonwealth University.'}, {'ForeName': 'Karen D', 'Initials': 'KD', 'LastName': 'Hendricks-Munoz', 'Affiliation': 'Department of Pediatrics, Virginia Commonwealth University.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Stevenson', 'Affiliation': 'Division of Development & Behavioral Pediatrics, University of Virginia.'}, {'ForeName': 'Leroy R', 'Initials': 'LR', 'LastName': 'Thacker', 'Affiliation': 'Department of Biostatistics, Virginia Commonwealth University.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Molinini', 'Affiliation': 'Rehabilitation Movement Sciences Program and Motor Development Lab, Virginia Commonwealth University.'}]",Physical therapy,['10.1093/ptj/pzaa077']
119,31398066,"A comparative assessment of orthodontic treatment outcomes of mild skeletal Class III malocclusion between facemask and facemask in combination with a miniscrew for anchorage in growing patients:  A single-center, prospective randomized controlled trial .","OBJECTIVES


To investigate the hypothesis that there is difference in the treatment outcomes of milder skeletal Class III malocclusion between facemask and facemask in combination with a miniscrew in growing patients.
MATERIALS AND METHODS


Patients were randomly divided into two groups. In one group, the patients were treated with facemask therapy (FM group: 12 males, eight females, average age: 10 years, 5 months ± 1 year, 8 months). In the other group, patients were treated with facemask therapy along with a miniscrew (FM+MS group: 12 males, seven females, average age: 11 years, 1 month ± 1 year, 3 months). A lingual arch with hooks was fixed to the maxillary arch in both groups and a protractive force of 500 g was applied from the facemask to the hooks. The patients were instructed to use the facemask for 12 hours per day. In the FM+MS group, a miniscrew was inserted into the palate and fixed to the lingual arch.
RESULTS


Mobility and loosening of the miniscrew were not observed during treatment. Lateral cephalometric analysis showed that SNA, SN-ANS, and ANB values were significantly increased in the FM+MS group compared with those for the FM group (SNA, 1.1° SN-ANS, 1.3° ANB, 0.8°). Increase in proclination of maxillary incisors was significantly greater in the FM group than in the FM+MS group (U1-SN, 5.0°).
CONCLUSIONS


During treatment of milder skeletal Class III malocclusion, facemask therapy along with a miniscrew exhibits fewer negative side effects and delivers orthopedic forces more efficiently to the maxillary complex than facemask therapy alone.",2020,"Increase in proclination of maxillary incisors was significantly greater in the FM group than in the FM+MS group (U1-SN, 5.0°).
","['group: 12 males, eight females, average age: 10 years, 5 months ± 1 year, 8 months', 'mild skeletal Class III malocclusion between', 'group: 12 males, seven females, average age: 11 years, 1 month ± 1 year, 3 months', 'Patients were randomly divided into two groups', 'growing patients']","['facemask therapy along with a miniscrew (FM+MS', 'facemask and facemask', 'facemask therapy (FM', 'FM', 'FM+MS']","['Increase in proclination of maxillary incisors', 'SNA, SN-ANS, and ANB values', 'Mobility and loosening of the miniscrew']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0399526', 'cui_str': 'Habsburg Jaw'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0021156', 'cui_str': 'Incisor'}, {'cui': 'C0068053', 'cui_str': 'N-hydroxysuccinimidyl-5-azido-2-nitrobenzoate'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0333050', 'cui_str': 'Loosening (morphologic abnormality)'}]",,0.0189837,"Increase in proclination of maxillary incisors was significantly greater in the FM group than in the FM+MS group (U1-SN, 5.0°).
","[{'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Seiryu', 'Affiliation': ''}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Ida', 'Affiliation': ''}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Mayama', 'Affiliation': ''}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Sasaki', 'Affiliation': ''}, {'ForeName': 'Shutaro', 'Initials': 'S', 'LastName': 'Sasaki', 'Affiliation': ''}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Deguchi', 'Affiliation': ''}, {'ForeName': 'Teruko', 'Initials': 'T', 'LastName': 'Takano-Yamamoto', 'Affiliation': ''}]",The Angle orthodontist,['10.2319/101718-750.1']
120,31403695,"The Impact of E-liquid Propylene Glycol and Vegetable Glycerin Ratio on Ratings of Subjective Effects, Reinforcement Value, and Use in Current Smokers.","INTRODUCTION


Electronic nicotine delivery systems (ENDS) vary on a wide range of characteristics that may affect reinforcement value and use. One characteristic is the ratio of two solvents commonly used in most e-liquids: propylene glycol (PG) and vegetable glycerin (VG). The goal of this study was to understand how PG/VG ratio affects subjective effects, reinforcement value, and tobacco use patterns among current smokers who try using ENDS.
AIMS AND METHODS


Current smokers with minimal ENDS use history (n = 30) sampled, in a double-blind fashion, three different e-liquids that varied in PG/VG ratio (70/30, 50/50, 0/100) while holding constant other aspects of the e-liquid and ENDS. Participants tried each e-liquid before rating the subjective effects on a modified version of the Cigarette Evaluation Questionnaire. Reinforcement value was assessed using a preference task where participants chose between the three e-liquids. The impact of each e-liquid on cigarette reinforcement was assessed using a modified version of the Cigarette Purchase Task. Participants were randomly assigned to receive one e-liquid to take home for 1 week.
RESULTS


PG/VG ratio had minimal impact on most of the tested outcomes. Participants rated the highest PG concentration as having a stronger ""throat hit"" than the other two. There was no significant difference between the number of participants who preferred each of the PG/VG ratios in the preference assessment. PG/VG ratio did not affect cigarette or ENDS use during the sampling week.
CONCLUSIONS


These data suggest that PG/VG ratio has minimal impact on subjective effects and reinforcement value in ENDS naive current smokers.
IMPLICATIONS


These data suggest that PG/VG ratio, within the range that is commonly used, has minimal impact on subjective effects, reinforcement value, or uptake in current smokers with minimal ENDS experience.",2020,There was no significant difference between the number of participants who preferred each of the PG/VG ratios in the preference assessment.,"['current smokers who try using ENDS', 'Current smokers with minimal ENDS use history (n=30) sampled, in a double-blind fashion, three different e-liquids that varied in PG/VG ratio (70/30, 50/50, 0/100) while holding constant other aspects of the e-liquid and ENDS', 'current smokers']","['e-liquid propylene glycol and vegetable glycerin ratio', 'glycol (PG) and vegetable glycerin (VG', 'Electronic Nicotine Delivery Systems (ENDS']","['PG/VG ratios', 'Reinforcement value', 'highest PG concentration', 'PG/VG ratio']","[{'cui': 'C3241966'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C4543628', 'cui_str': 'Electronic cigarette liquid (physical object)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1553387', 'cui_str': 'Hold'}, {'cui': 'C1720529', 'cui_str': 'Constant'}]","[{'cui': 'C4543628', 'cui_str': 'Electronic cigarette liquid (physical object)'}, {'cui': 'C4046690', 'cui_str': 'propylene glycol, (S)-'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0017951', 'cui_str': 'Glycols'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0908702,There was no significant difference between the number of participants who preferred each of the PG/VG ratios in the preference assessment.,"[{'ForeName': 'Tracy T', 'Initials': 'TT', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Bryan W', 'Initials': 'BW', 'LastName': 'Heckman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Wahlquist', 'Affiliation': 'Cancer Control and Prevention, Hollings Cancer Center, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'K Michael', 'Initials': 'KM', 'LastName': 'Cummings', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz130']
121,31132095,Optimizing Warnings on E-Cigarette Advertisements.,"INTRODUCTION


We examined the effect of visual optimizations on warning text recall.
METHODS


We used Amazon's Mechanical Turk to recruit 1854 young adult (18-34 years) electronic cigarette (e-cigarette) users or susceptible nonusers. We conducted a between-subjects 3 × 2 × 2 experiment to examine the influence of color (black text on white background [BW] vs. black on yellow [BY] vs. yellow on black [YB]), shape (rectangle vs. novel), and signal word (presence vs. absence of the word ""warning""). We randomized participants to view one of 12 warnings on a fictional e-cigarette advertisement. We coded open-ended recall responses into three categories: (1) recalled nothing, (2) recalled something, (3) recalled the concept. We examined main effects on warning text recall using multinomial regression. We examined differences in attention, perceived message effectiveness, and appeal.
RESULTS


Those exposed to BW or BY warnings were more likely than those exposed to YB to recall something (AOR = 1.6, AOR = 1.5, respectively) or the concept (OR = 1.4, BW). Those exposed to novel shape (44.7% novel vs. 37.9% rectangle; p = .003) or color (44.5% BY vs. 41.9% YB vs. 37.5% BW; p = .04) warnings were more likely to report attention to the warning. In aided recall, those exposed to the signal word were more likely than those not exposed to select the correct response (64.0% vs. 31.3%; p < .0001). We did not find differences for message effectiveness or appeal.
CONCLUSIONS


Visual optimizations such as color may influence warning text recall and should be considered for new warnings. Research should continue exploring variations for advertisement warnings to maximize attention to warning text.
IMPLICATIONS


This study examines the impact of visual optimizations on recall of the US Food and Drug Administration-mandated e-cigarette advertisement warning text. We found that color might influence warning text recall, but we did not find effects for shape or signal word. It is possible the newly mandated e-cigarette advertisement warnings, which are required to occupy at least 20% of the advertisement, are currently novel enough to attract attention. Future research should examine optimizations following implementation of the new advertisement warnings.",2020,Those exposed to novel shape (44.7% novel vs 37.9% rectangle; p=.003) or color (44.5% BY vs 41.9% YB vs 37.5% BW; p=.04) warnings were more likely to report attention to the warning.,"['1854 young adult (18-34) e-cigarette users or susceptible non-users', 'participants to view one of 12 warnings on a fictional e-cigarette advertisement']","['visual optimizations', 'color (black text on white background [BW']",[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4087159', 'cui_str': 'Electronic cigarette user (finding)'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]",[],1854.0,0.01347,Those exposed to novel shape (44.7% novel vs 37.9% rectangle; p=.003) or color (44.5% BY vs 41.9% YB vs 37.5% BW; p=.04) warnings were more likely to report attention to the warning.,"[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'King', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Lazard', 'Affiliation': 'School of Media and Journalism, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Reboussin', 'Affiliation': 'Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Ranney', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cornacchione Ross', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Kimberly G', 'Initials': 'KG', 'LastName': 'Wagoner', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Sutfin', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz091']
122,31306076,Rapid maxillary expansion in children with nocturnal enuresis:  A randomized placebo-controlled trial .,"OBJECTIVE


To investigate whether rapid maxillary expansion (RME) is a useful treatment method for nocturnal enuresis (NE) and whether the treatment effect is due to placebo. The study also aimed to identify prognostic variables in patients responding to treatment.
MATERIALS AND METHODS


Thirty-eight children with therapy-resistant NE were recruited and randomized into two groups: the intervention group or placebo group. Both groups were treated with RME, but the placebo group received treatment with a sham appliance for 2 weeks before having the actual treatment. A medical history focused on micturition habits, previous treatment, heredity, and sleep disorders was taken. Daytime voided volumes and nocturnal urine production during wet nights were recorded before the intervention.
RESULTS


Of the 38 patients recruited, two dropped out as one patient was unable to take dental impressions and one refused to have the appliance fitted. There was a statistically significant reduction of wet nights after the RME treatment ( P  < .001). No significant reduction was found after the placebo treatment ( P  < .40). Eleven patients (35%) had their enuresis frequency reduced by >50%. Large voiding volume and a wide maxilla at baseline had a strong association with positive treatment outcome.
CONCLUSIONS


RME has a modest effect on children with therapy-resistant NE. The treatment outcome does not seem to be due to a placebo effect of the appliance. A wide maxillary width and large voiding volume at baseline seem to be positive predictors regarding response to treatment.",2020,There was a statistically significant reduction of wet nights after the RME treatment ( P  < .001).,"['38 patients recruited, two dropped out as one patient was unable to take dental impressions and', 'children with nocturnal enuresis', 'Thirty-eight children with therapy-resistant NE', 'children with therapy-resistant NE', 'patients responding to treatment', 'nocturnal enuresis (NE']","['RME', 'placebo', 'rapid maxillary expansion (RME']","['enuresis frequency', 'Daytime voided volumes and nocturnal urine production', 'reduction of wet nights', 'Large voiding volume']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C1299582', 'cui_str': 'Unable'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0270327', 'cui_str': 'Nighttime Urinary Incontinence'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0600288', 'cui_str': 'Maxillary Expansion'}]","[{'cui': 'C0403670', 'cui_str': 'Urinary incontinence of non-organic origin (finding)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0033268'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205381', 'cui_str': 'Wet (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",38.0,0.117553,There was a statistically significant reduction of wet nights after the RME treatment ( P  < .001).,"[{'ForeName': 'Ingrid Jönson', 'Initials': 'IJ', 'LastName': 'Ring', 'Affiliation': ''}, {'ForeName': 'Tryggve', 'Initials': 'T', 'LastName': 'Nevéus', 'Affiliation': ''}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Markström', 'Affiliation': ''}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Magnuson', 'Affiliation': ''}, {'ForeName': 'Farhan', 'Initials': 'F', 'LastName': 'Bazargani', 'Affiliation': ''}]",The Angle orthodontist,['10.2319/031819-219.1']
123,31613144,Frankel 2 appliance versus the Modified Twin Block appliance for Phase 1 treatment of Class II division 1 malocclusion in children and adolescents:  A randomized clinical trial .,"OBJECTIVE


To compare Phase 1 treatment, using the Frankel 2 (FR2) or the modified Twin Block (MTB), for Class II division 1 malocclusion in children and adolescents with respect to: treatment duration, number of appliance breakages, occlusal outcome, and patient and parent perspectives.
MATERIALS AND METHODS


Sixty participants with a Class II division 1 malocclusion were randomly assigned to either the FR2 or MTB appliance in a two-armed parallel randomized clinical trial with an allocation ratio of 1 to 1. Time to achieve a Class I incisor relationship was the primary outcome. The number of appliance breakages was recorded. The Peer Assessment Rating (PAR) index was used to evaluate pre- and post-treatment occlusal outcome on study models. Participants completed the child OHRQoL (oral health-related quality of life), Piers-Harris, Standard Continuum of Aesthetic Need (SCAN), and Oral Aesthetic Subjective Impact Score (OASIS) questionnaires pre- and post-treatment; parents completed a SCAN questionnaire.
RESULTS


Forty-two participants completed treatment (FR2: 20; MTB: 22). Multiple imputation was used to impute missing data for noncompleters. Mean treatment duration was similar for the two appliances (FR2: 376 days [SD 101]; MTB: 340 days [SD 102];  P  = .41). There were no significant differences in mean number of appliance breakages (FR2: 0.3 SD 0.7; MTB: 0.4 SD 0.8;  P  = .67 or mean PAR score  P  = .48). Patient and parent perspectives did not differ between appliances ( P  > .05).
CONCLUSIONS


Phase 1 treatment duration, number of appliance breakages, occlusal outcome, and patient and parent perspectives were similar in 11-14 year olds with Class II division 1 malocclusion treated using the FR2 or MTB appliance.",2020,Mean treatment duration was similar for the two appliances (FR2: 376 days [SD 101]; MTB: 340 days [SD 102];  P  = .41).,"['children and adolescents with respect to: treatment duration, number of appliance breakages, occlusal outcome, and patient and parent perspectives', 'Sixty participants with a Class II division 1 malocclusion', 'Class II division 1 malocclusion in children and adolescents']","['Frankel 2 (FR2) or the modified Twin Block (MTB), for Class II division 1 malocclusion', 'FR2 or MTB appliance', 'Frankel 2 appliance versus the Modified Twin Block appliance']","['number of appliance breakages, occlusal outcome, and patient and parent perspectives', 'Mean treatment duration', 'Peer Assessment Rating (PAR) index', 'child OHRQoL (oral health-related quality of life), Piers-Harris, Standard Continuum of Aesthetic Need (SCAN), and Oral Aesthetic Subjective Impact Score (OASIS) questionnaires pre- and post-treatment; parents completed a SCAN questionnaire', 'number of appliance breakages', 'mean number of appliance breakages']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0243112'}, {'cui': 'C1947917', 'cui_str': 'Occluded (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0399524', 'cui_str': 'Malocclusion, Angle Class II, Division 1'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0399524', 'cui_str': 'Malocclusion, Angle Class II, Division 1'}, {'cui': 'C0243112'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0243112'}, {'cui': 'C1947917', 'cui_str': 'Occluded (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0429164', 'cui_str': 'Peer assessment rating (orthodontic index)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0029162'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0441633'}]",60.0,0.119875,Mean treatment duration was similar for the two appliances (FR2: 376 days [SD 101]; MTB: 340 days [SD 102];  P  = .41).,"[{'ForeName': 'Ciara', 'Initials': 'C', 'LastName': 'Campbell', 'Affiliation': ''}, {'ForeName': 'Declan', 'Initials': 'D', 'LastName': 'Millett', 'Affiliation': ''}, {'ForeName': 'Niamh', 'Initials': 'N', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Cooke', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cronin', 'Affiliation': ''}]",The Angle orthodontist,['10.2319/042419-290.1']
124,32318647,Neurokinin 3 Receptor Antagonists Do Not Increase FSH or Estradiol Secretion in Menopausal Women.,"Background


Neurokinin 3 receptor (NK3R) antagonism is a promising novel treatment for menopausal flashes. However, to avoid adverse hormonal effects it is clinically important to first confirm whether gonadotropin and estradiol concentrations change as a result of their administration.
Methods


Single-center, randomized, double-blind, placebo-controlled, crossover trial of an oral NK3R antagonist (MLE4901) in 28 women aged 40 to 62 years, experiencing >7 hot flashes/24 h; some bothersome or severe (Clinicaltrials.gov, NCT02668185). Weekly serum gonadotropins and estradiol levels were measured using commercially available automated immunoassays a priori. Serum estradiol was also measured post hoc using a highly sensitive direct assay by liquid chromatography tandem mass spectrometry. Hormone levels were compared by the paired sample  t  tests or by the Wilcoxon matched-pairs signed rank test, as appropriate for the distribution of the data.
Results


Mean (standard deviation) serum follicle-stimulating hormone (FSH) concentration was not significantly increased when taking MLE4901 (72.07 ± 19.81 IU/L) compared to placebo (70.03 ± 19.56 IU/L),  P  = .26. Serum estradiol was also not significantly altered, irrespective of which assay method was used (median interquartile range of serum estradiol by immunoassay: placebo 36 ± 3 pmol/L, MLE4901 36 ± 1 pmol/L,  P  = .21; median serum highly sensitive estradiol: placebo 12 ± 16 pmol/L, MLE4901 13 ± 15 pmol/L,  P  = .70). However, mean (standard deviation) serum luteinizing hormone concentration significantly decreased with MLE4901 (27.63 ± 9.76 IU/L) compared to placebo (30.26 ± 9.75 IU/L),  P  = .0024.
Implication


NK3R antagonists do not increase serum estradiol or FSH despite their reduction in hot flashes. This is clinically significant and highly reassuring for women who have a contraindication to conventional hormone therapy such as prior/existing breast cancer and/or thromboembolism.",2020,"Mean (standard deviation) serum follicle-stimulating hormone (FSH) concentration was not significantly increased when taking MLE4901 (72.07 ± 19.81 IU/L) compared to placebo (70.03 ± 19.56 IU/L),  P  = .26.","['women who have a contraindication to conventional hormone therapy such as prior/existing breast cancer and/or thromboembolism', '28 women aged 40 to 62 years, experiencing >7 hot flashes/24 h; some bothersome or severe (Clinicaltrials.gov, NCT02668185', 'Menopausal Women']","['oral NK3R antagonist (MLE4901', '\n\n\nNeurokinin 3 receptor (NK3R) antagonism', 'placebo']","['Serum estradiol', 'Weekly serum gonadotropins and estradiol levels', 'Mean (standard deviation) serum follicle-stimulating hormone (FSH) concentration', 'mean (standard deviation) serum luteinizing hormone concentration', 'serum estradiol or FSH', 'FSH or Estradiol Secretion', 'Hormone levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0068603', 'cui_str': 'Neuromedin K Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0857927', 'cui_str': 'Serum follicle stimulating hormone'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}]",28.0,0.318722,"Mean (standard deviation) serum follicle-stimulating hormone (FSH) concentration was not significantly increased when taking MLE4901 (72.07 ± 19.81 IU/L) compared to placebo (70.03 ± 19.56 IU/L),  P  = .26.","[{'ForeName': 'Julia K', 'Initials': 'JK', 'LastName': 'Prague', 'Affiliation': 'Section of Endocrinology & Investigative Medicine, Imperial College, London, UK.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Abbara', 'Affiliation': 'Section of Endocrinology & Investigative Medicine, Imperial College, London, UK.'}, {'ForeName': 'Alexander N', 'Initials': 'AN', 'LastName': 'Comninos', 'Affiliation': 'Section of Endocrinology & Investigative Medicine, Imperial College, London, UK.'}, {'ForeName': 'Channa N', 'Initials': 'CN', 'LastName': 'Jayasena', 'Affiliation': 'Section of Endocrinology & Investigative Medicine, Imperial College, London, UK.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Higham', 'Affiliation': 'Department of Endocrinology, The Christie NHS Foundation Trust, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Adaway', 'Affiliation': 'Biochemistry Department, Wythenshawe Hospital, Wythenshawe, UK.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Keevil', 'Affiliation': 'Biochemistry Department, Wythenshawe Hospital, Wythenshawe, UK.'}, {'ForeName': 'Johannes D', 'Initials': 'JD', 'LastName': 'Veldhuis', 'Affiliation': 'Mayo Clinic, Rochester, MN, UK.'}, {'ForeName': 'Waljit S', 'Initials': 'WS', 'LastName': 'Dhillo', 'Affiliation': 'Section of Endocrinology & Investigative Medicine, Imperial College, London, UK.'}]",Journal of the Endocrine Society,['10.1210/jendso/bvz009']
125,32329160,Exenatide once weekly decreases urinary albumin excretion in patients with type 2 diabetes and elevated albuminuria: Pooled analysis of randomized active controlled clinical trials.,"AIMS


To examine the albuminuria-lowering effect of exenatide once weekly (EQW) compared with active glucose-lowering comparators in patients with type 2 diabetes and elevated urinary albumin-to-creatinine ratio (uACR).
METHODS


Six randomized double-blind and open-label phase III studies were pooled in a post hoc, exploratory analysis to evaluate the efficacy and safety of EQW versus non-glucagon-like peptide-1 receptor agonist comparators in patients with type 2 diabetes and baseline uACR ≥30 mg/g. Treatment groups were EQW versus all comparators pooled. Efficacy outcomes were percent change from baseline to week 26/28 in uACR and absolute change in glycated haemoglobin (HbA1c), systolic blood pressure (SBP), body weight and estimated glomerular filtration rate (eGFR).
RESULTS


Baseline characteristics were generally similar between the two treatment groups (EQW: N = 194, all comparators: N = 274). Relative to the comparator group, EQW changed albuminuria by -26.2% (95% confidence interval [CI] -39.5 to -10). Similar improvements were observed with EQW versus oral glucose-lowering drugs (-29.6% [95% CI -47.6 to -5.3) or insulin (-23.8% [95% CI -41.8 to -0.2]). The effect of EQW on uACR was independent of baseline renin-angiotensin system inhibitor usage. Adjusted mean decreases in HbA1c, SBP and body weight were more pronounced in the EQW versus the comparator group. Adjustment for changes in HbA1c, eGFR and SBP did not substantially affect the uACR-lowering effect of EQW. When also adjusting for changes in body weight, the uACR-lowering effect was reduced to (-13.0% [95% CI -29.9 to 7.8]).
CONCLUSION


Exenatide once weekly reduced uACR in patients with type 2 diabetes and elevated albuminuria compared to commonly used glucose-lowering drugs.",2020,EQW reduced uACR in patients with T2D and elevated albuminuria compared to commonly used glucose-lowering drugs.,"['patients with type 2 diabetes and elevated albuminuria', 'patients with type 2 diabetes (T2D', 'patients with diabetes and chronic kidney disease', 'patients with T2D and baseline uACR ≥30']","['exenatide once weekly (EQW', 'active glucose-lowering comparators', 'glucagon-like peptide-1 receptor agonists (GLP-1 RA', 'EQW', 'Exenatide']","['urine albumin-to-creatinine ratio (uACR', 'HbA1c, SBP and BW', 'uACR lowering effect', 'glycated haemoglobin (HbA1c), systolic blood pressure (SBP), body weight (BW) and estimated glomerular filtration rate (eGFR', 'urinary albumin excretion', 'EQW changed albuminuria', 'EQW versus oral glucose-lowering drugs', 'EQW reduced uACR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",,0.280552,EQW reduced uACR in patients with T2D and elevated albuminuria compared to commonly used glucose-lowering drugs.,"[{'ForeName': 'Annemarie B', 'Initials': 'AB', 'LastName': 'van der Aart-van der Beek', 'Affiliation': 'Clinical Pharmacy and Pharmacology, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'van Raalte', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam UMC location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Guja', 'Affiliation': 'Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.'}, {'ForeName': 'Klaas', 'Initials': 'K', 'LastName': 'Hoogenberg', 'Affiliation': 'Department of Internal Medicine, Martini Hospital, Groningen, The Netherlands.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Suchower', 'Affiliation': 'Kelly Services, Gaithersburg, Maryland.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Hardy', 'Affiliation': 'Clinical Metabolism, Late-stage Development, Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'Clinical Metabolism, Late-stage Development, Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Clinical Pharmacy and Pharmacology, University of Groningen, Groningen, The Netherlands.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14067']
126,32326983,Examining the impact of a social skills training program on preschoolers' social behaviors: a cluster-randomized controlled trial in child care centers.,"BACKGROUND


Preschoolers regularly display disruptive behaviors in child care settings because they have not yet developed the social skills necessary to interact prosocially with others. Disruptive behaviors interfere with daily routines and can lead to conflict with peers and educators. We investigated the impact of a social skills training program led by childcare educators on children's social behaviors and tested whether the impact varied according to the child's sex and family socio-economic status.
METHODS


Nineteen public Child Care Centers (CCC, n = 361 children) located in low socio-economic neighborhoods of Montreal, Canada, were randomized into one of two conditions: 1) intervention (n = 10 CCC; 185 children) or 2) wait list control (n = 9 CCC; 176 children). Educators rated children's behaviors (i.e., disruptive and prosocial behaviors) before and after the intervention. Hierarchical linear mixed models were used to account for the nested structure of the data.
RESULTS


At pre-intervention, no differences in disruptive and prosocial behaviors were observed between the experimental conditions. At post-intervention, we found a significant sex by intervention interaction (β intervention by sex = - 1.19, p = 0.04) indicating that girls in the intervention condition exhibited lower levels of disruptive behaviors compared to girls in the control condition (f2 effect size = - 0.15). There was no effect of the intervention for boys.
CONCLUSIONS


Girls may benefit more than boys from social skills training offered in the child care context. Studies with larger sample sizes and greater intervention intensity are needed to confirm the results.
TRIAL REGISTRATION


Current clinical trial number is ISRCTN84339956 (Retrospectively registered in March 2017). No amendment to initial protocol.",2020,"At post-intervention, we found a significant sex by intervention interaction (β intervention by sex = - 1.19, p = 0.04) indicating that girls in the intervention condition exhibited lower levels of disruptive behaviors compared to girls in the control condition (f2 effect size = - 0.15).","['child care centers', ""preschoolers' social behaviors"", 'Nineteen public Child Care Centers (CCC, n\u2009=\u2009361 children) located in low socio-economic neighborhoods of Montreal, Canada']","['social skills training program', 'intervention (n\u2009=\xa010 CCC; 185 children) or 2) wait list control']","['disruptive and prosocial behaviors', ""children's behaviors (i.e., disruptive and prosocial behaviors"", 'disruptive behaviors', ""children's social behaviors""]","[{'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0037397', 'cui_str': 'Social behavior'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0150777', 'cui_str': 'Social skills training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037397', 'cui_str': 'Social behavior'}]",,0.0774927,"At post-intervention, we found a significant sex by intervention interaction (β intervention by sex = - 1.19, p = 0.04) indicating that girls in the intervention condition exhibited lower levels of disruptive behaviors compared to girls in the control condition (f2 effect size = - 0.15).","[{'ForeName': 'Marie-Pier', 'Initials': 'MP', 'LastName': 'Larose', 'Affiliation': 'Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ouellet-Morin', 'Affiliation': 'Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Vergunst', 'Affiliation': 'Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Vitaro', 'Affiliation': 'Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Girard', 'Affiliation': 'Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'E Tremblay', 'Affiliation': 'Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Brendgen', 'Affiliation': 'Université du Québec à Montréal, Montreal, Canada.'}, {'ForeName': 'Sylvana', 'Initials': 'S', 'LastName': 'M Côté', 'Affiliation': 'Université de Montréal, Montreal, Canada. sylvana.cote.1@umontreal.ca.'}]",BMC psychology,['10.1186/s40359-020-00408-2']
127,32304484,Comparative assessment of the corneal incision enlargement of 4 preloaded IOL delivery systems.,"PURPOSE


To compare the corneal incision size enlargement after intraocular lens (IOL) implantation of a new, automated, preloaded delivery system, AutonoMe (system A), vs that of 3 other available preloaded systems (UltraSert [system U], Vivinex iSert [system V], and Tecnis iTec [system T]).
SETTING


Alcon Vision LLC, Fort Worth, Texas, USA.
DESIGN


Experimental study.
METHODS


Human cadaver eyes were randomly assigned to receive IOLs implanted with the preloaded delivery devices. Corneal incisions were imaged using optical coherence tomography, and incision sizes were measured using an Asico incision gauge before and after IOL delivery. Differences in mean incision enlargement between delivery devices were evaluated using a paired t test.
RESULTS


System A (mean ± standard deviation, 0.29 ± 0.03 mm) and system U (0.29 ± 0.03 mm) had the smallest mean incision size enlargement compared with system T (0.31 ± 0.03 mm) and system V (0.36 ± 0.06 mm). System V had the largest corneal incision enlargement and was significantly larger than system A (P = .001), system U (P = .001), and system T (P = .002). System A was noninferior to system U; the paired difference in corneal incision enlargement between the devices was -0.01 ± 0.04 mm (90% CI, -0.03 to 0.01).
CONCLUSIONS


The new system A preloaded delivery system provided smaller corneal incision enlargement compared with system T or system V and was noninferior to system U.",2020,"System V had the largest corneal incision enlargement and was significantly larger than system A (P=0.001), system U (P=0.001), and system T (P=0.002).",['Human cadaver eyes'],"['IOLs implanted with the preloaded delivery devices', 'corneal incision size enlargement after intraocular lens (IOL) implantation']","['corneal incision enlargement', 'mean incision enlargement', 'largest corneal incision enlargement']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0006629', 'cui_str': 'Cadaver'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0549177', 'cui_str': 'Large'}]",,0.0387625,"System V had the largest corneal incision enlargement and was significantly larger than system A (P=0.001), system U (P=0.001), and system T (P=0.002).","[{'ForeName': 'Jingbo', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'From Alcon Vision LLC (Liu, Wolfe, Hernandez), Fort Worth, Texas, USA; and the Department of Ophthalmology, Goethe-University (Kohnen), Frankfurt, Germany.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Wolfe', 'Affiliation': ''}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Hernandez', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kohnen', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000214']
128,32326563,Oral l-Cysteine Supplementation Enhances the Long Term-Effect of Topical Basic Fibroblast Growth Factor (bFGF) in Reducing the Corneal Haze after Photorefractive Keratectomy in Myopic Patients.,"We aimed at evaluating the long-term effects of l-cysteine oral supplementation to basic fibroblast growth factor (bFGF) eye-drops on corneal re-epithelization and transparency in myopic patients subjected to photorefractive keratectomy (PRK). Forty patients subjected to bilateral PRK for myopia were enrolled and randomly divided into two groups receiving an additional therapy together with the standard postoperative treatment consisting in local tobramycin 0.3%, dexamethasone 0.1%, diclofenac 0.1%, and 0.2% hyaluronate. Group 1 included 20 patients (11 males and 9 females; 34.09 ± 8 years of age) receiving only bFGF eye-drops (10 μg/10 μL) four times a day for 7 days starting from the day of surgery; Group 2 included 20 patients (12 males and 8 females; 37.35 ± 11.5 years of age) who were postoperatively administered with topical basic fibroblast growth factor (bFGF; 10 μg/10 μL) four times a day for 7 days plus oral l-cysteine supplementation (500 mg/capsule) once a day for 15 days, starting 7 days before PRK. Patients were followed-up for 12 months. Clinical ophthalmologic parameters were recorded for all the 80 examined eyes. The corneal transparency was evaluated in vivo by slit lamp and confocal microscopy. The data showed that: (a) the corneal haze occurred in a smaller percentage of the patients who were postoperatively administered with topical bFGF plus oral l-cysteine supplementation (Group 2) compared to patients who received only bFGF (Group 1); (b) at 6 months of follow-up, the stromal mean image brightness of the patients belonging to Group 2 was significantly lower than that of the Group 1 ( p  < 0.03), and, interestingly, the difference was even more evident at 12 month from the treatment ( p  < 0.001). Moreover, the final mean of the spherical equivalent refraction was -0.06 ± 0.2 D in Group 1 and -0.08 ± 0.3 D in Group 2, whereas the final uncorrected distance visual acuity (UDVA) was equal or superior to 20/25 in 100% of eyes in both Group 1 and 2. Post refractive patients can benefit from the administration of l-cysteine before the surgery and in association with bFGF in the early postoperative period, showing a faster corneal re-epithelization able to prevent corneal haze in the long-term recovery.",2020,"Moreover, the final mean of the spherical equivalent refraction was -0.06 ± 0.2 D in Group 1 and -0.08 ± 0.3 D in Group 2, whereas the final uncorrected distance visual acuity (UDVA) was equal or superior to 20/25 in 100% of eyes in both Group 1 and 2.","['Myopic Patients', 'myopic patients subjected to photorefractive keratectomy (PRK', 'Group 1 included 20 patients (11 males and 9 females; 34.09 ± 8 years of age) receiving only bFGF eye-drops (10 μg/10 μL) four times a day for 7 days starting from the day of surgery; Group 2 included 20 patients (12 males and 8 females; 37.35 ± 11.5 years of age) who were postoperatively administered with', 'Forty patients subjected to bilateral PRK for myopia']","['Oral l-Cysteine Supplementation', 'topical basic fibroblast growth factor (bFGF', 'oral l-cysteine supplementation', 'bFGF', 'additional therapy together with the standard postoperative treatment consisting in local tobramycin 0.3%, dexamethasone 0.1%, diclofenac 0.1%, and 0.2% hyaluronate', 'Topical Basic Fibroblast Growth Factor (bFGF', 'l-cysteine oral supplementation to basic fibroblast growth factor (bFGF) eye-drops', 'topical bFGF plus oral l-cysteine supplementation']","['final uncorrected distance visual acuity (UDVA', 'corneal haze', 'Clinical ophthalmologic parameters', 'corneal transparency', 'stromal mean image brightness', 'spherical equivalent refraction']","[{'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0395416', 'cui_str': 'Refractive keratoplasty by laser surgery'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0380603', 'cui_str': 'Fibroblast Growth Factor-2'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0010654', 'cui_str': 'Cysteine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0380603', 'cui_str': 'Fibroblast Growth Factor-2'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0178695', 'cui_str': 'hyaluronate'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0010038', 'cui_str': 'Corneal opacity'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}]",40.0,0.0337873,"Moreover, the final mean of the spherical equivalent refraction was -0.06 ± 0.2 D in Group 1 and -0.08 ± 0.3 D in Group 2, whereas the final uncorrected distance visual acuity (UDVA) was equal or superior to 20/25 in 100% of eyes in both Group 1 and 2.","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Meduri', 'Affiliation': 'Biomedical, Dental and Morphological and Functional Images Sciences, Department, University of Messina, 98122 Messina, Italy.'}, {'ForeName': 'Loredana', 'Initials': 'L', 'LastName': 'Bergandi', 'Affiliation': 'Department of Oncology, University of Torino, 10126 Torino, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Perroni', 'Affiliation': 'Biomedical, Dental and Morphological and Functional Images Sciences, Department, University of Messina, 98122 Messina, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Silvagno', 'Affiliation': 'Department of Oncology, University of Torino, 10126 Torino, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Aragona', 'Affiliation': 'Biomedical, Dental and Morphological and Functional Images Sciences, Department, University of Messina, 98122 Messina, Italy.'}]","Pharmaceuticals (Basel, Switzerland)",['10.3390/ph13040067']
129,32316764,ISCHEMIA-CKD: Contemporary Randomized Clinical Data at Last.,,2020,,[],['ISCHEMIA-CKD'],[],[],"[{'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]",[],,0.0350864,,"[{'ForeName': 'Glenn N', 'Initials': 'GN', 'LastName': 'Levine', 'Affiliation': 'Baylor College of Medicine and Michael E. DeBakey VA Medical Center, Houston, TX.'}, {'ForeName': 'Mirza', 'Initials': 'M', 'LastName': 'Umair Khalid', 'Affiliation': 'Baylor College of Medicine and Michael E. DeBakey VA Medical Center, Houston, TX.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.045009']
130,32329780,High-Flow Oxygen Therapy During Exercise Training in Patients With Chronic Obstructive Pulmonary Disease and Chronic Hypoxemia: A Multicenter Randomized Controlled Trial.,"OBJECTIVE


The study aimed to evaluate whether high-flow oxygen therapy (HFOT) during training was more effective than oxygen in improving exercise capacity in hypoxemic chronic obstructive pulmonary disease (COPD).
METHODS


A total of 171 patients with COPD and chronic hypoxemia were consecutively recruited in 8 rehabilitation hospitals in a randomized controlled trial. Cycle-ergometer exercise training was used in 20 supervised sessions at iso inspiratory oxygen fraction in both groups. Pre- and post-training endurance time (Tlim), 6-minute walking distance (6MWD), respiratory and limb muscle strength, arterial blood gases, Barthel Index, Barthel Dyspnea Index, COPD Assessment Test, Maugeri Respiratory Failure questionnaire, and patient satisfaction were evaluated.
RESULTS


Due to 15.4% and 24.1% dropout rates, 71 and 66 patients were analyzed in HFOT and Venturi mask (V-mask) groups, respectively. Exercise capacity significantly improved after training in both groups with similar patient satisfaction. Between-group difference in post-training improvement in 6MWD (mean: 17.14 m; 95% CI = 0.87 to 33.43 m) but not in Tlim (mean: 141.85 seconds; 95% CI = -18.72 to 302.42 seconds) was significantly higher in HFOT. The minimal clinically important difference of Tlim was reached by 47% of patients in the V-mask group and 56% of patients in the HFOT group, whereas the minimal clinically important difference of 6MWD was reached by 51% of patients in the V-mask group and 69% of patients in the HFOT group, respectively.
CONCLUSION


In patients with hypoxemic COPD, exercise training is effective in improving exercise capacity.
IMPACT STATEMENT


The addition of HFOT during exercise training is not more effective than oxygen through V-mask in improving endurance time, the primary outcome, whereas it is more effective in improving walking distance.",2020,,['Patients With Chronic Obstructive Pulmonary Disease and Chronic Hypoxemia'],"['High-Flow Oxygen Therapy', 'Exercise Training']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]",[],,0.296169,,"[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Vitacca', 'Affiliation': 'Respiratory Rehabilitation Department, Istituti Clinici Scientifici Maugeri IRCCS, Via Salvatore Maugeri, 4 - 27100 Pavia, Italy.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Paneroni', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Lumezzane, Istituti Clinici Scientifici Maugeri IRCCS, Brescia, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Zampogna', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Tradate, Istituti Clinici Scientifici Maugeri IRCCS, Varese, Italy.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Visca', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Tradate, Istituti Clinici Scientifici Maugeri IRCCS, Varese, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Carlucci', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Pavia, Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Cirio', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Pavia, Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Banfi', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Milano, IRCCS Fondazione Don Gnocchi, Milano, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Pappacoda', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Milano, IRCCS Fondazione Don Gnocchi, Milano, Italy.'}, {'ForeName': 'Ludovico', 'Initials': 'L', 'LastName': 'Trianni', 'Affiliation': 'Respiratory Rehabilitation of Villa Pineta, Pavullo nel Frignano, Modena, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Brogneri', 'Affiliation': 'Respiratory Rehabilitation of Villa Pineta, Pavullo nel Frignano, Modena, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Belli', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Veruno, Istituti Clinici Scientifici Maugeri IRCCS, Novara, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Paracchini', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Veruno, Istituti Clinici Scientifici Maugeri IRCCS, Novara, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Aliani', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Cassano delle Murge, Istituti Clinici Scientifici Maugeri IRCCS, Bari, Italy.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Spinelli', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Cassano delle Murge, Istituti Clinici Scientifici Maugeri IRCCS, Bari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Gigliotti', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Firenze, IRCCS Fondazione Don Gnocchi, Firenze, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Lanini', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Firenze, IRCCS Fondazione Don Gnocchi, Firenze, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Lazzeri', 'Affiliation': ""Ospedale Niguarda Ca' Granda, Milano, Italy.""}, {'ForeName': 'Enrico M', 'Initials': 'EM', 'LastName': 'Clini', 'Affiliation': 'Department of Medical and Surgical Sciences, Università degli Studi Modena e Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Malovini', 'Affiliation': 'Laboratory of Informatics and Systems Engineering for Clinical Research of the Institute of Pavia, Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy.'}, {'ForeName': 'Nicolino', 'Initials': 'N', 'LastName': 'Ambrosino', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Montescano, Istituti Clinici Scientifici Maugeri IRCCS, Montescano, Pavia, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Physical therapy,['10.1093/ptj/pzaa076']
131,30346511,Clinical and Virologic Outcomes Following Initiation of Antiretroviral Therapy Among Seroconverters in the Microbicide Trials Network-020 Phase III Trial of the Dapivirine Vaginal Ring.,"BACKGROUND


A vaginal ring containing dapivirine, a non-nucleoside human immunodeficiency virus (HIV)-1 reverse transcriptase inhibitor (NNRTI), was safe and effective in preventing HIV-1 infection in African women. We examined the impact of dapivirine ring use at the time of HIV-1 acquisition on subsequent HIV-1 disease progression and responses to NNRTI-containing antiretroviral therapy (ART).
METHODS


HIV-1 disease progression and virologic failure following initiation of ART were assessed among women who acquired HIV-1 while participating in Microbicide Trials Network-020, a randomized, placebo-controlled trial of a monthly, dapivirine vaginal ring.
RESULTS


Among the 158 participants who acquired HIV-1 (65 dapivirine, 93 placebo), no differences between dapivirine and placebo participants were observed in CD4+ cell counts or plasma HIV-1 RNA over the first year after infection (prior to ART). During follow-up, 100/158 (63%) participants initiated NNRTI-containing ART (dapivirine: 39/65; placebo: 61/93); the median time to HIV-1 RNA <200 copies/ml was approximately 90 days for both dapivirine and placebo ring recipients (log-rank P = .40). Among the 81 participants with at least 6 months of post-ART follow-up, 19 (24%) experienced virologic failure (dapivirine: 6/32, 19%; placebo: 13/39, 27%; P = .42).
CONCLUSIONS


The acquisition of HIV-1 infection during dapivirine or placebo treatment in ASPIRE did not lead to differences in HIV-1 disease progression. After the initiation of NNRTI-containing ART, dapivirine and placebo participants had similar times to virologic suppression and risks of virologic failure. These results provide reassurance that NNRTI-based ART regimens are effective among women who acquired HIV-1 while receiving the dapivirine vaginal ring.
CLINICAL TRIALS REGISTRATION


NCT016170096 and NCT00514098.",2019,"Among 158 participants who acquired HIV-1 (65 dapivirine, 93 placebo), no differences between dapivirine and placebo participants were observed in CD4+ cell counts or plasma HIV-1 RNA over the first year after infection (prior to ART).","['women who acquired HIV-1 while receiving the dapivirine vaginal ring', 'women who acquired HIV-1 while participating in MTN-020/ASPIRE', 'Seroconverters in the MTN-020/ASPIRE Phase III Trial of the Dapivirine Vaginal Ring', '158 participants who acquired HIV-1 (65 dapivirine, 93', 'African women']","['dapivirine or placebo', 'dapivirine and placebo', 'placebo', 'NNRTI-containing ART, dapivirine and placebo', 'NNRTI-containing antiretroviral therapy (ART', 'dapivirine, a non-nucleoside HIV-1 reverse transcriptase inhibitor (NNRTI']","['CD4+ cell counts or plasma HIV-1 RNA', 'median time to HIV-1 RNA', 'virologic suppression and risk of virologic failure', 'virologic failure', 'HIV-1 disease progression']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C1434916', 'cui_str': '4-((4-((2,4,6-trimethylphenyl)amino)pyrimidin-2-yl)amino)benzonitrile'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C1434916', 'cui_str': '4-((4-((2,4,6-trimethylphenyl)amino)pyrimidin-2-yl)amino)benzonitrile'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0028621', 'cui_str': 'Nucleosides'}, {'cui': 'C0121925', 'cui_str': 'HIV-1 reverse transcriptase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1699206', 'cui_str': 'Virologic failure'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}]",81.0,0.569704,"Among 158 participants who acquired HIV-1 (65 dapivirine, 93 placebo), no differences between dapivirine and placebo participants were observed in CD4+ cell counts or plasma HIV-1 RNA over the first year after infection (prior to ART).","[{'ForeName': 'Sharon A', 'Initials': 'SA', 'LastName': 'Riddler', 'Affiliation': 'University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Balkus', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Urvi M', 'Initials': 'UM', 'LastName': 'Parikh', 'Affiliation': 'University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Mellors', 'Affiliation': 'University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Carolyne', 'Initials': 'C', 'LastName': 'Akello', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Sufia', 'Initials': 'S', 'LastName': 'Dadabhai', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Blantyre, Malawi.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Mhlanga', 'Affiliation': 'University of Zimbabwe, Harare.'}, {'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Ramjee', 'Affiliation': 'South African Medical Research Council, Durban.'}, {'ForeName': 'Ashley J', 'Initials': 'AJ', 'LastName': 'Mayo', 'Affiliation': 'FHI 360, Durham, North Carolina.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Livant', 'Affiliation': 'Magee-Womens Research Institute & Foundation, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Heaps', 'Affiliation': 'University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': ""O'Rourke"", 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy909']
132,30397257,Longitudinal effect of 20-year infancy-onset dietary intervention on food consumption and nutrient intake: the randomized controlled STRIP study.,"BACKGROUND/OBJECTIVES


Coronary heart disease begins in childhood and warrants prevention strategies such as dietary modification. The objective was to determine the effect of the Special Turku Coronary Risk Factor Intervention Project (STRIP) dietary intervention on food consumption and nutrient intake over 20-year intervention period.
SUBJECTS/METHODS


The STRIP is a prospective, randomized trial conducted between 1990 and 2011. Enrolled 6-month-old infants (n = 1062) were randomized to an intervention group (n = 540) receiving dietary counseling biannually from age 7 months to 20 years or control group (n = 522) not receiving any intervention. Food and nutrient intake was assessed annually using 4-day food records. A food-based diet score was calculated.
RESULTS


The intervention led to (1) higher consumption of low-fat unsweetened dairy (β = 177.76, 95% CI 157.36-198.16 g/day), vegetable-oil based fats (β = 6.00, 5.37-6.63 g/day), fish (β = 2.45, 1.44-3.45 g/day), fiber-rich grain products (β = 5.53, 3.17-7.89 g/day), fruits/berries (β = 9.93, 4.44-15.43 g/day), vegetables (β = 11.95, 7.74-16.16 g/day); (2) lower consumption of desserts (β = - 4.10, 95% CI - 6.50 to - 1.70 g/day); (3) lower intake of sucrose (β = - 1.61, 95% CI - 2.88 to - 0.35 g/day), and higher intake of fiber (β = 0.83, 0.55-1.11 g/day), folate (β = 11.14, 95% CI 8.23-14.05 μg/day), vitamin D (β = 0.52, 0.39-0.64 μg/day), C (β = 8.08, 4.79-11.38 mg/day), E (β = 0.93, 0.81-1.05 mg/day), iron (β = 0.31, 0.18-0.44 mg/day), zinc (β = 0.29, 0.17-0.40 mg/day), magnesium (β = 12.17, 9.02-15.33 mg/day), sodium (β = 55.00, 24.40-85.60 mg/day), potassium (β = 157.11, 107.24-206.98 mg/day). No effect was found on nut/seed, red/processed meat, sugar-sweetened beverage, salty snack consumption, or vitamin A and calcium intake. Intervention effect was more pronounced in boys.
CONCLUSIONS


The STRIP intervention improved children's diet quality over 20 years, indicating that beneficial dietary changes can be introduced and sustained in youth.",2019,"The STRIP intervention improved children's diet quality over 20 years, indicating that beneficial dietary changes can be introduced and sustained in youth.","['Enrolled 6-month-old infants (n\u2009=\u20091062', '1990 and 2011']","['magnesium (β\u2009=\u200912.17', 'Special Turku Coronary Risk Factor Intervention Project (STRIP) dietary intervention', 'STRIP intervention', 'intervention group (n\u2009=\u2009540) receiving dietary counseling biannually from age 7 months to 20 years or control group (n\u2009=\u2009522) not receiving any intervention', '20-year infancy-onset dietary intervention']","['food consumption and nutrient intake', 'nut/seed, red/processed meat, sugar-sweetened beverage, salty snack consumption, or vitamin A and calcium intake', ""children's diet quality"", 'Food and nutrient intake']","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C1321564', 'cui_str': 'Strip'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0585342', 'cui_str': 'Every other year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517804', 'cui_str': 'Five hundred and twenty-two'}, {'cui': 'C0231330', 'cui_str': 'Infancy - period'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0028723', 'cui_str': 'Nuts'}, {'cui': 'C0036563', 'cui_str': 'Zygotes, Plant'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0452956', 'cui_str': 'Processed meat (substance)'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",,0.15859,"The STRIP intervention improved children's diet quality over 20 years, indicating that beneficial dietary changes can be introduced and sustained in youth.","[{'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'Matthews', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Turku, Finland.'}, {'ForeName': 'Suvi P', 'Initials': 'SP', 'LastName': 'Rovio', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Turku, Finland.'}, {'ForeName': 'Johanna M', 'Initials': 'JM', 'LastName': 'Jaakkola', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Turku, Finland.'}, {'ForeName': 'Harri', 'Initials': 'H', 'LastName': 'Niinikoski', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Lagström', 'Affiliation': 'Department of Public Health, University of Turku, Turku, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Jula', 'Affiliation': 'National Institute for Health and Welfare, Turku, Finland.'}, {'ForeName': 'Jorma S A', 'Initials': 'JSA', 'LastName': 'Viikari', 'Affiliation': 'Department of Medicine, University of Turku and Division of Medicine, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Tapani', 'Initials': 'T', 'LastName': 'Rönnemaa', 'Affiliation': 'Department of Medicine, University of Turku and Division of Medicine, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Olli', 'Initials': 'O', 'LastName': 'Simell', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Turku, Finland.'}, {'ForeName': 'Olli T', 'Initials': 'OT', 'LastName': 'Raitakari', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Turku, Finland.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Pahkala', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Turku, Finland. katja.pahkala@utu.fi.'}]",European journal of clinical nutrition,['10.1038/s41430-018-0350-4']
133,30596964,Comparison of 3 Days Amoxicillin Versus 5 Days Co-Trimoxazole for Treatment of Fast-breathing Pneumonia by Community Health Workers in Children Aged 2-59 Months in Pakistan: A Cluster-randomized Trial.,"BACKGROUND


Globally, most deaths due to childhood pneumonia occur at the community level. Some countries are still using oral co-trimoxazole, despite a World Health Organization recommendation of oral amoxicillin for the treatment of fast-breathing pneumonia in children at the community level.
METHODS


We conducted an unblinded, cluster-randomized, controlled-equivalency trial in Haripur District, Pakistan. Children 2-59 months of age with fast-breathing pneumonia were treated with oral amoxicillin suspension (50 mg/kg/day) for 3 days in 14 intervention clusters and oral co-trimoxazole suspension (8 mg trimethoprim/kg and 40 mg sulfamethoxazole/kg/day) for 5 days in 14 control clusters by lady health workers (LHW). The primary outcome was treatment failure by day 4 for intervention clusters and by day 6 for control clusters. The analysis was per protocol.
RESULTS


Out of the 15 749 cases enrolled in the study, 9153 cases in intervention and 6509 cases in control clusters were included in the analysis. Treatment failure rates were 3.6% (326) in intervention clusters and 9.1% (592) in control clusters. After adjusting for clustering, the risk of treatment failure was lower in intervention clusters (risk difference [RD] -5.5%, 95% confidence interval [CI] -7.4--3.7%) than in control clusters. Children with incomplete adherence had a small increase in treatment failure versus those with complete adherence (RD 2.9%, 95% CI 1.6-4.1%). No deaths or serious adverse events occurred.
CONCLUSIONS


A 3-day course of oral amoxicillin, administered by LHWs, is an effective and safe treatment for fast-breathing pneumonia in children 2-59 months of age. A shorter course of amoxicillin improves adherence to therapy, is low in cost, and puts less pressure on antimicrobial resistance.
CLINICAL TRIALS REGISTRATION


ISRCTN10618300.",2019,"After adjusting for clustering, the risk of treatment failure was lower in intervention clusters (risk difference [RD] -5.5%,","['Children 2-59 months of age with fast-breathing pneumonia', 'fast-breathing pneumonia in children at the community level', '9153 cases in intervention and 6509 cases in control clusters were included in the analysis', 'Haripur District, Pakistan', '15 749 cases enrolled in the study', 'Aged 2-59 Months in Pakistan', 'fast-breathing pneumonia in children 2-59 months of age', 'Children']","['amoxicillin', 'oral co-trimoxazole suspension (8 mg trimethoprim/kg and 40 mg sulfamethoxazole', 'Amoxicillin Versus 5 Days Co-Trimoxazole', 'oral amoxicillin suspension', 'oral amoxicillin']","['deaths or serious adverse events', 'treatment failure by day 4 for intervention clusters and by day 6 for control clusters', 'Treatment failure rates']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0041044', 'cui_str': 'Sulfamethoxazole / Trimethoprim'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0041041', 'cui_str': 'Trimethoprim'}, {'cui': 'C0038689', 'cui_str': 'Sulfamethoxazole'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0162643'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",15749.0,0.111435,"After adjusting for clustering, the risk of treatment failure was lower in intervention clusters (risk difference [RD] -5.5%,","[{'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Sadruddin', 'Affiliation': 'World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Ibad Ul Haque', 'Initials': 'IUH', 'LastName': 'Khan', 'Affiliation': 'Monitoring and Evaluation Consultant, Islamabad, Pakistan.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Fox', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Massachusetts.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Bari', 'Affiliation': 'Independent Consultant, Islamabad.'}, {'ForeName': 'Attaullah', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Directorate General, Health Services, Khyber Pakhtunkhwa.'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Thea', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Massachusetts.'}, {'ForeName': 'Amanullah', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'White Ribbon Alliance, Islamabad.'}, {'ForeName': 'Inamullah', 'Initials': 'I', 'LastName': 'Khan', 'Affiliation': ""United Nations International Children's Emergency Fund Peshawar.""}, {'ForeName': 'Ijaz', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': 'Health Sector Reform Unit, Department of Health, Khyber Pakhtunkhwa, Pakistan.'}, {'ForeName': 'Shamim A', 'Initials': 'SA', 'LastName': 'Qazi', 'Affiliation': 'Independent Consultant, Geneva, Switzerland.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy918']
134,31872219,Determinants and Measurement of Neonatal Vitamin D: Overestimation of 25(OH)D in Cord Blood Using CLIA Assay Technology.,"CONTEXT


Vitamin D (VD) deficiency in pregnancy and the neonatal period has impacts on childhood outcomes. Maternal VD sufficiency is crucial for sufficiency in the neonate, though the effect of early versus late pregnancy 25-hydroxy-vitamin D (25(OH)D) levels on neonatal levels is unknown. Furthermore, chemiluminescence immunoassays (CLIAs) are widely used, though their validity in measuring 25(OH)D specifically in cord blood specimens has not been established.
OBJECTIVE


To assess the validity of a CLIA in the measurement of cord blood 25(OH)D and to evaluate maternal determinants of neonatal 25(OH)D, including early versus late pregnancy 25(OH)D levels.
DESIGN


This is an ancillary analysis from the Vitamin D Antenatal Asthma Reduction Trial (VDAART), a randomized, double-blinded, placebo-controlled study.
PARTICIPANTS AND INTERVENTION


A total of 881 pregnant women at high risk of having offspring asthma were randomized to receive VD supplementation or placebo. Serum samples were collected from mothers in early and late pregnancy and from offspring cord blood at birth. 25(OH)D levels were assayed by CLIA in all maternal and offspring samples and by LC-MS/MS in all offspring samples and a subset of 200 maternal third trimester samples.
RESULTS


Cord blood 25(OH)D levels were higher as measured by CLIA (mean 37.13 ng/mL [SD 18.30]) than by LC-MS/MS (mean 23.54 ng/mL [SD 11.99]), with a mean positive bias of 13.54 ng/mL (SD 12.92) by Bland-Altman analysis. This positive bias in measurement by CLIA was not observed in maternal samples. Third trimester 25(OH)D was a positive determinant of neonatal 25(OH)D levels.
CONCLUSION


Chemiluminescence immunoassays overestimate 25(OH)D levels in human cord blood samples, an effect not observed in maternal blood samples. The quantification of 25(OH)D by CLIA should therefore not be considered valid when assayed in cord blood samples. Third trimester, but not first trimester, maternal 25(OH)D is one of several determinants of neonatal 25(OH)D status.",2020,"RESULTS


Cord blood 25(OH)D levels were higher as measured by CLIA [mean 37.13 ng/mL (SD 18.30)] than by LC-MS/MS [mean 23.54 ng/mL (SD 11.99)], with a mean positive bias of 13.54 ng/mL (SD 12.92) by Bland-Altman analysis.",[],['placebo'],"['maternal blood samples', 'neonatal 25(OH)D levels', 'Cord blood 25(OH)D levels']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}]",,0.154264,"RESULTS


Cord blood 25(OH)D levels were higher as measured by CLIA [mean 37.13 ng/mL (SD 18.30)] than by LC-MS/MS [mean 23.54 ng/mL (SD 11.99)], with a mean positive bias of 13.54 ng/mL (SD 12.92) by Bland-Altman analysis.","[{'ForeName': 'Mengdi', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Hollis', 'Affiliation': 'Department of Pediatrics, University of South Carolina School of Medicine, Charleston, South Carolina.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Carey', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Laranjo', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Ravinder J', 'Initials': 'RJ', 'LastName': 'Singh', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Weiss', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Augusto A', 'Initials': 'AA', 'LastName': 'Litonjua', 'Affiliation': ""Department of Pediatrics, Golisano Children's Hospital at Strong, University of Rochester Medical Center, Rochester, New York.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz299']
135,31646469,Reducing motion-correction-induced variability in  82 rubidium myocardial blood-flow quantification.,"BACKGROUND


Clinical use of myocardial blood flow (MBF) and flow reserve (MFR) is increasing. Motion correction is necessary to obtain accurate results but can introduce variability when performed manually. We sought to reduce that variability with an automated motion-correction algorithm.
METHODS


A blinded randomized controlled trial of two technologists was performed on the motion correction of 100 dynamic  82 Rb patient studies comparing manual motion correction with manual review and adjustment of automated motion correction. Inter-rater variability between technologists for MBF and MFR was the primary outcome with comparison made by analysis of the limits of agreement. Processing time was the secondary outcome.
RESULTS


Limits of agreements between the two technologists decreased significantly for both MBF and MFR, going from [- 0.22, 0.22] mL/min/g and [- 0.31, 0.36] to [- 0.12, 0.15] mL/min/g and [- 0.15, 0.18], respectively (both P < .002). In addition, the average time spent on motion correcting decreased by 1 min per study from 5:21 to 4:21 min (P = .001).
CONCLUSIONS


In this randomized controlled trial, the use of automated motion correction significantly decreased inter-user variability and reduced processing time.",2020,"RESULTS


Limits of agreements between the two technologists decreased significantly for both MBF and MFR, going from [- 0.22, 0.22] mL/min/g and [- 0.31, 0.36] to [- 0.12, 0.15] mL/min/g and [- 0.15, 0.18], respectively (both P < .002).",[],['manual motion correction with manual review and adjustment of automated motion correction'],"['myocardial blood flow (MBF) and flow reserve (MFR', 'average time spent on motion correcting', 'inter-user variability and reduced processing time', 'MBF and MFR']",[],"[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C1264663', 'cui_str': 'Mass fraction'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]",100.0,0.0787528,"RESULTS


Limits of agreements between the two technologists decreased significantly for both MBF and MFR, going from [- 0.22, 0.22] mL/min/g and [- 0.31, 0.36] to [- 0.12, 0.15] mL/min/g and [- 0.15, 0.18], respectively (both P < .002).","[{'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Poitrasson-Rivière', 'Affiliation': 'INVIA Medical Imaging Solutions, 3025 Boardwalk Dr. Suite 200, Ann Arbor, MI, 48108, USA. apoitrasson@inviasolutions.com.'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Moody', 'Affiliation': 'INVIA Medical Imaging Solutions, 3025 Boardwalk Dr. Suite 200, Ann Arbor, MI, 48108, USA.'}, {'ForeName': 'Tomoe', 'Initials': 'T', 'LastName': 'Hagio', 'Affiliation': 'INVIA Medical Imaging Solutions, 3025 Boardwalk Dr. Suite 200, Ann Arbor, MI, 48108, USA.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Weinberg', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine and Frankel Cardiovascular Center, University of Michigan, Ann Arbor, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Corbett', 'Affiliation': 'Division of Nuclear Medicine, Department of Radiology and Frankel Cardiovascular Center, University of Michigan, Ann Arbor, USA.'}, {'ForeName': 'Venkatesh L', 'Initials': 'VL', 'LastName': 'Murthy', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine and Frankel Cardiovascular Center, University of Michigan, Ann Arbor, USA.'}, {'ForeName': 'Edward P', 'Initials': 'EP', 'LastName': 'Ficaro', 'Affiliation': 'INVIA Medical Imaging Solutions, 3025 Boardwalk Dr. Suite 200, Ann Arbor, MI, 48108, USA.'}]",Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology,['10.1007/s12350-019-01911-9']
136,30358811,Procalcitonin-guided Antibiotic Treatment in Patients With Positive Blood Cultures: A Patient-level Meta-analysis of Randomized Trials.,"BACKGROUND


Whether procalcitonin (PCT)-guided antibiotic management in patients with positive blood cultures is safe remains understudied. We performed a patient-level meta-analysis to investigate effects of PCT-guided antibiotic management in patients with bacteremia.
METHODS


We extracted and analyzed individual data of 523 patients with positive blood cultures included in 13 trials, in which patients were randomly assigned to receive antibiotics based on PCT levels (PCT group) or a control group. The main efficacy endpoint was duration of antibiotic treatment. The main safety endpoint was mortality within 30 days.
RESULTS


Mean duration of antibiotic therapy was significantly shorter for 253 patients who received PCT-guided treatment than for 270 control patients (-2.86 days [95% confidence interval [CI], -4.88 to -.84]; P = .006). Mortality was similar in both arms (16.6% vs 20.0%; P = .263). In subgroup analyses by type of pathogen, we noted a trend of shorter mean antibiotic durations in the PCT arm for patients infected with gram-positive organisms or Escherichia coli and significantly shorter treatment for subjects with pneumococcal bacteremia. In analysis by site of infection, antibiotic exposure was shortened in PCT subjects with Streptococcus pneumoniae respiratory infection and those with E. coli urogenital infections.
CONCLUSIONS


This meta-analysis of patients with bacteremia receiving PCT-guided antibiotic management demonstrates lower antibiotic exposure without an apparent increase in mortality. Few differences were demonstrated in subgroup analysis stratified by type or site of infection but notable for decreased exposure in patients with pneumococcal pneumonia and E. coli urogenital infections.",2019,"Mortality was similar in both arms (16.6% vs 20.0%, p=0.263).","['patients with positive blood cultures', '253 patients who received', 'patients with bacteremia receiving', 'patients with bacteremia overall and stratified based on type of pathogen', '523 patients with positive blood cultures included in 13 trials (7 studies evaluating patients with acute respiratory illnesses, 6 studies patients with sepsis']","['antibiotics based on PCT levels (PCT group) or a control group', 'PCT', 'PCT-guided antibiotic management', 'Procalcitonin-guided antibiotic treatment', 'procalcitonin (PCT)-guided antibiotic management']","['Mortality', 'Mean duration of antibiotic therapy', 'pneumococcal bacteremia', 'duration of antibiotic treatment', 'mortality', 'mean antibiotic durations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0740299', 'cui_str': 'Blood culture positive for microorganism'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0162566', 'cui_str': 'Porphyria Cutanea Tarda'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1535922', 'cui_str': 'Procalcitonin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C1142127', 'cui_str': 'Pneumococcal bacteraemia'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",523.0,0.213937,"Mortality was similar in both arms (16.6% vs 20.0%, p=0.263).","[{'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Meier', 'Affiliation': 'Medical University Department, Kantonsspital Aarau, Switzerland.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Branche', 'Affiliation': 'Department of Medicine, University of Rochester, Rochester General Hospital, New York.'}, {'ForeName': 'Olivia L', 'Initials': 'OL', 'LastName': 'Neeser', 'Affiliation': 'Medical University Department, Kantonsspital Aarau, Switzerland.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Wirz', 'Affiliation': 'Medical University Department, Kantonsspital Aarau, Switzerland.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Haubitz', 'Affiliation': 'Medical University Department, Kantonsspital Aarau, Switzerland.'}, {'ForeName': 'Lila', 'Initials': 'L', 'LastName': 'Bouadma', 'Affiliation': 'Service de Réanimation Médicale, Université Paris 7-Denis-Diderot, Assistance Publique-Hôpitaux de Paris (AP-HP), France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Wolff', 'Affiliation': 'Service de Réanimation Médicale, Université Paris 7-Denis-Diderot, Assistance Publique-Hôpitaux de Paris (AP-HP), France.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Luyt', 'Affiliation': 'Service de Réanimation Médicale, Université Paris 6-Pierre-et-Marie-Curie, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Chastre', 'Affiliation': 'Service de Réanimation Médicale, Université Paris 6-Pierre-et-Marie-Curie, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Tubach', 'Affiliation': ""Département d'Epidémiologie Biostatistique et Recherche Clinique, AP-HP, Hôpitaux Universitaires Paris Nord Val de Seine, France.""}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Christ-Crain', 'Affiliation': 'Division of Endocrinology, Diabetology and Clinical Nutrition, University Hospital Basel, Switzerland.'}, {'ForeName': 'Caspar', 'Initials': 'C', 'LastName': 'Corti', 'Affiliation': 'Department of Respiratory Medicine, Copenhagen University Hospital Bispebjerg, Denmark.'}, {'ForeName': 'Jens-Ulrik S', 'Initials': 'JS', 'LastName': 'Jensen', 'Affiliation': 'Centre of Excellence for Health, Immunity and Infections, Department of Infectious Diseases and Rheumatology, Finsencentret, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Rodrigo O', 'Initials': 'RO', 'LastName': 'Deliberato', 'Affiliation': 'Critical Care Unit, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Kristina B', 'Initials': 'KB', 'LastName': 'Kristoffersen', 'Affiliation': 'Department of Infectious Diseases, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Damas', 'Affiliation': 'Department of General Intensive Care, University Hospital of Liege, Domaine universitaire de Liège, Belgium.'}, {'ForeName': 'Vandack', 'Initials': 'V', 'LastName': 'Nobre', 'Affiliation': 'Department of Intensive Care, Hospital das Clinicas, Belo Horizonte, Brazil.'}, {'ForeName': 'Carolina F', 'Initials': 'CF', 'LastName': 'Oliveira', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Shehabi', 'Affiliation': 'Critical Care and Peri-operative Medicine, Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Daiana', 'Initials': 'D', 'LastName': 'Stolz', 'Affiliation': 'Clinic of Pneumology and Pulmonary Cell Research, University Hospital Basel, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tamm', 'Affiliation': 'Clinic of Pneumology and Pulmonary Cell Research, University Hospital Basel, Switzerland.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Mueller', 'Affiliation': 'Medical University Department, Kantonsspital Aarau, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Schuetz', 'Affiliation': 'Medical University Department, Kantonsspital Aarau, Switzerland.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy917']
137,30388194,"Blood Schizonticidal Activity and Safety of Tafenoquine When Administered as Chemoprophylaxis to Healthy, Nonimmune Participants Followed by Blood Stage Plasmodium falciparum Challenge: A Randomized, Double-blind, Placebo-controlled Phase 1b Study.","BACKGROUND


Tafenoquine was recently approved for chemoprophylaxis of malaria. Its specific activity against liver and blood stages of Plasmodium species has been separately characterized in animals but not in humans.
METHODS


In this randomized, double-blind, placebo-controlled study, 16 malaria-naive, glucose-6-phosphate dehydrogenase-normal participants aged 20-42 years received tafenoquine chemoprophylaxis prior to challenge with blood stage Plasmodium falciparum. Participants were randomly assigned to either tafenoquine (n = 12) or placebo (n = 4) and took blinded study medication (single 200-mg dose) on days 1, 2, 3, and 10, followed by intravenous inoculation with approximately 2800 P. falciparum parasitized erythrocytes on day 13. The primary endpoint was the number of participants requiring rescue treatment with artemether/lumefantrine due to the onset of parasitemia as determined by quantitative polymerase chain reaction.
RESULTS


None of the 12 participants who received tafenoquine developed parasitemia, whereas all placebo participants developed parasitemia (P = .0005). Two cases of mild hemoglobin decrease and a single case of mild hyperbilirubinemia occurred in the tafenoquine group.
CONCLUSIONS


Tafenoquine chemoprophylaxis is safe and effective in preventing malaria in healthy nonimmune participants challenged with blood stage P. falciparum.
CLINICAL TRIALS REGISTRATION


Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12617000102370.",2019,"Conclusions


Tafenoquine chemoprophylaxis is safe and effective in preventing malaria in healthy non-immune participants challenged with blood stage P. falciparum.","['prior to challenge with blood stage P. falciparum', '16 malaria naïve, G6PD-normal participants aged 20-42 years received', 'healthy, non-immune participants followed by blood stage Plasmodium falciparum challenge', 'healthy non-immune participants challenged with blood stage P. falciparum']","['tafenoquine chemoprophylaxis', 'placebo', 'Tafenoquine chemoprophylaxis', 'tafenoquine']","['Blood schizonticidal activity and safety', 'mild hyperbilirubinemia', 'number of participants requiring rescue treatment with artemether/lumefantrine due to the onset of parasitemia as determined by qPCR', 'parasitemia']","[{'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0005768'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0032150', 'cui_str': 'Plasmodium falciparum'}]","[{'cui': 'C0903411', 'cui_str': 'tafenoquine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005768'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0020433', 'cui_str': 'Bilirubinemia'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0936150', 'cui_str': 'artemether / lumefantrine'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}]",,0.682178,"Conclusions


Tafenoquine chemoprophylaxis is safe and effective in preventing malaria in healthy non-immune participants challenged with blood stage P. falciparum.","[{'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'McCarthy', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Queensland.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Smith', 'Affiliation': '60P Australia Pty Ltd, Sydney, New South Wales.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Reid', 'Affiliation': 'Graythan Regulatory Services Pty Ltd, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Berman', 'Affiliation': 'Fast-Track Drugs and Biologicals LLC, North Potomac.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Marquart', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Queensland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dobbin', 'Affiliation': 'Clinical Network Services Pty Ltd, Brisbane, Queensland, Australia.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'West', 'Affiliation': 'Clinical Network Services Pty Ltd, Brisbane, Queensland, Australia.'}, {'ForeName': 'Lisa T', 'Initials': 'LT', 'LastName': 'Read', 'Affiliation': 'US Army Medical Materiel Development Activity, Fort Detrick, Maryland.'}, {'ForeName': 'Geoff S', 'Initials': 'GS', 'LastName': 'Dow', 'Affiliation': '60P Australia Pty Ltd, Sydney, New South Wales.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy939']
138,32323437,Impact of disease duration and β-cell reserve on the efficacy of switching to iGlarLixi in adults with type 2 diabetes on glucagon-like peptide-1 receptor agonist therapy: Exploratory analyses from the LixiLan-G trial.,"AIM


To evaluate the efficacy of iGlarLixi by C-peptide levels and duration of diabetes in an exploratory analysis of the LixiLan-G study.
METHODS


LixiLan-G was a 26-week, randomized, open-label study in adults with type diabetes (T2D) inadequately controlled while on a glucagon-like peptide-1 receptor agonist (GLP-1 RA), with metformin, with or without pioglitazone and/or a sodium-glucose co-transporter-2 inhibitor. This analysis investigated the efficacy of switching to iGlarLixi by fasting baseline quartile C-peptide levels and baseline quartile of duration of T2D compared with continued GLP-1 RA use.
RESULTS


Change in glycated hemoglobin (HbA1c) from baseline to week 26 was significantly greater with iGlarLixi compared with continued GLP-1 RAs across all fasting C-peptide quartiles (-1.00% to -1.06% vs. -0.23% to -0.54% range, respectively) and irrespective of all T2D duration quartiles (-0.94% to -1.07% vs. -0.25% to -0.50% range). A significantly greater proportion of participants in the iGlarLixi arm achieved an HbA1c of <7% across all C-peptide quartiles (51%-73% range) than in the GLP-1 RA arm (19%-32% range). The greatest reductions in HbA1c in participants receiving iGlarLixi were observed in those with the shortest duration of disease, although consistently greater than reductions observed with continued GLP-1 RAs. Reductions in HbA1c were comparable across C-peptide quartiles within the iGlarLixi arm.
CONCLUSIONS


The results of this study suggest that iGlarLixi is an effective treatment option, irrespective of C-peptide levels or duration of diabetes, in adults with insufficiently controlled T2D receiving GLP-1 RAs.",2020,A significantly greater proportion of participants in the iGlarLixi arm achieved an HbA1c of <7% across all C-peptide quartiles (51%-73% range) than in the GLP-1 RA arm (19%-32% range).,"['adults with insufficiently controlled T2D receiving GLP-1 RAs', 'adults with type 2 diabetes on GLP-1 receptor agonist therapy', 'type 2 diabetes (T2D', 'adults with T2D inadequately controlled while on']","['iGlarLixi', 'LixiLan-G', 'switching to iGlarLixi', 'glucagon-like peptide 1 receptor agonist (GLP-1 RA), with metformin, with/without pioglitazone and/or a sodium-glucose cotransporter 2 inhibitor']","['glycated hemoglobin (HbA1c', 'fasting C-peptide quartiles']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}]",,0.0585292,A significantly greater proportion of participants in the iGlarLixi arm achieved an HbA1c of <7% across all C-peptide quartiles (51%-73% range) than in the GLP-1 RA arm (19%-32% range).,"[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Del Prato', 'Affiliation': 'University of Pisa, Pisa, Italy.'}, {'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Frias', 'Affiliation': 'National Research Institute, Los Angeles, California, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Blonde', 'Affiliation': 'Ochsner Medical Center, New Orleans, Louisiana, USA.'}, {'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Niam', 'Initials': 'N', 'LastName': 'Shehadeh', 'Affiliation': 'The Rambam Academic Hospital, Haifa, Israel.'}, {'ForeName': 'Aramesh', 'Initials': 'A', 'LastName': 'Saremi', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Dex', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Niemoeller', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Souhami', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Minzhi', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'BDM Consulting Inc., Somerset, New Jersey, USA.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center, Dallas, Texas, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14068']
139,31475799,Ticagrelor or Prasugrel in Patients with Acute Coronary Syndromes.,"BACKGROUND


The relative merits of ticagrelor as compared with prasugrel in patients with acute coronary syndromes for whom invasive evaluation is planned are uncertain.
METHODS


In this multicenter, randomized, open-label trial, we randomly assigned patients who presented with acute coronary syndromes and for whom invasive evaluation was planned to receive either ticagrelor or prasugrel. The primary end point was the composite of death, myocardial infarction, or stroke at 1 year. A major secondary end point (the safety end point) was bleeding.
RESULTS


A total of 4018 patients underwent randomization. A primary end-point event occurred in 184 of 2012 patients (9.3%) in the ticagrelor group and in 137 of 2006 patients (6.9%) in the prasugrel group (hazard ratio, 1.36; 95% confidence interval [CI], 1.09 to 1.70; P = 0.006). The respective incidences of the individual components of the primary end point in the ticagrelor group and the prasugrel group were as follows: death, 4.5% and 3.7%; myocardial infarction, 4.8% and 3.0%; and stroke, 1.1% and 1.0%. Definite or probable stent thrombosis occurred in 1.3% of patients assigned to ticagrelor and 1.0% of patients assigned to prasugrel, and definite stent thrombosis occurred in 1.1% and 0.6%, respectively. Major bleeding (as defined by the Bleeding Academic Research Consortium scale) was observed in 5.4% of patients in the ticagrelor group and in 4.8% of patients in the prasugrel group (hazard ratio, 1.12; 95% CI, 0.83 to 1.51; P = 0.46).
CONCLUSIONS


Among patients who presented with acute coronary syndromes with or without ST-segment elevation, the incidence of death, myocardial infarction, or stroke was significantly lower among those who received prasugrel than among those who received ticagrelor, and the incidence of major bleeding was not significantly different between the two groups. (Funded by the German Center for Cardiovascular Research and Deutsches Herzzentrum München; ISAR-REACT 5 ClinicalTrials.gov number, NCT01944800.).",2019,"Definite or probable stent thrombosis occurred in 1.3% of patients assigned to ticagrelor and 1.0% of patients assigned to prasugrel, and definite stent thrombosis occurred in 1.1% and 0.6%, respectively.","['patients with acute coronary syndromes', 'patients who presented with acute coronary syndromes with or without ST-segment elevation', '4018 patients underwent randomization', 'patients who presented with acute coronary syndromes and for whom invasive evaluation was planned to receive either', 'Patients with Acute Coronary Syndromes']","['ticagrelor', 'Ticagrelor or Prasugrel', 'ticagrelor or prasugrel', 'prasugrel']","['stent thrombosis', 'Definite or probable stent thrombosis', 'incidence of major bleeding', 'bleeding', 'incidence of death, myocardial infarction, or stroke', 'death', 'myocardial infarction', 'Major bleeding', 'composite of death, myocardial infarction, or stroke at 1 year']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation (finding)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}]","[{'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",2006.0,0.0635407,"Definite or probable stent thrombosis occurred in 1.3% of patients assigned to ticagrelor and 1.0% of patients assigned to prasugrel, and definite stent thrombosis occurred in 1.1% and 0.6%, respectively.","[{'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Schüpke', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Franz-Josef', 'Initials': 'FJ', 'LastName': 'Neumann', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Menichelli', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Mayer', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Isabell', 'Initials': 'I', 'LastName': 'Bernlochner', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Wöhrle', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Richardt', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Liebetrau', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Witzenbichler', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Antoniucci', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Akin', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Bott-Flügel', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Fischer', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Landmesser', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Hugo A', 'Initials': 'HA', 'LastName': 'Katus', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Sibbing', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Melchior', 'Initials': 'M', 'LastName': 'Seyfarth', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Janisch', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Duino', 'Initials': 'D', 'LastName': 'Boncompagni', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Raphaela', 'Initials': 'R', 'LastName': 'Hilz', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Rottbauer', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Okrojek', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Möllmann', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Willibald', 'Initials': 'W', 'LastName': 'Hochholzer', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Migliorini', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Cassese', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Mollo', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Erion', 'Initials': 'E', 'LastName': 'Xhepa', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Kufner', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Strehle', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Leggewie', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Abdelhakim', 'Initials': 'A', 'LastName': 'Allali', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Gjin', 'Initials': 'G', 'LastName': 'Ndrepepa', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Schühlen', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Christian W', 'Initials': 'CW', 'LastName': 'Hamm', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hapfelmeier', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Tölg', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Trenk', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Schunkert', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Karl-Ludwig', 'Initials': 'KL', 'LastName': 'Laugwitz', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': 'From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1908973']
140,32268795,Sex Differences in Quality of Life and Clinical Outcomes in Patients With Advanced Heart Failure: Insights From the PAL-HF Trial.,"BACKGROUND


Palliative care improves quality of life in patients with heart failure. Whether men and women with heart failure derive similar benefit from palliative care interventions remains unknown.
METHODS


In a secondary analysis of the PAL-HF trial (Palliative Care in Heart Failure), we analyzed differences in quality of life among men and women with heart failure and assessed for differential effects of the palliative care intervention by sex. Differences in clinical characteristics and quality-of-life metrics were compared between men and women at serial time points. The primary outcome was change in Kansas City Cardiomyopathy Questionnaire score between baseline and 24 weeks.
RESULTS


Among the 71 women and 79 men, there was a significant difference in baseline Kansas City Cardiomyopathy Questionnaire (24.5 versus 36.2, respectively;  P =0.04) but not Functional Assessment of Chronic Illness Therapy-Palliative Care scale (115.7 versus 120.3;  P =0.27) scores. Among those who received the palliative care intervention (33 women and 42 men), women's quality-of-life score remained lower than that of men after enrollment. Treated men's scores were significantly higher than those untreated (6-month Kansas City Cardiomyopathy Questionnaire, 68.0 [interquartile range, 52.6-85.7] versus 41.1[interquartile range, 32.0-78.3];  P =0.047), whereas the difference between treated and untreated women was not significantly different ( P =0.39). Rates of death and rehospitalization, as well as the composite end point, were similar between treated and untreated women and men.
CONCLUSIONS


In the PAL-HF trial, women with heart failure experienced a greater symptom burden and poorer quality of life as compared with men. The change in treated men's Kansas City Cardiomyopathy Questionnaire score between baseline and 24 weeks was significantly higher than those untreated; this trend was not observed in women. Thus, there may be a sex disparity in response to palliative care intervention, suggesting that sex-specific approaches to palliative care may be needed to improve outcomes. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT0158960.",2020,"Rates of death and rehospitalization, as well as the composite end point, were similar between treated and untreated women and men.
","['patients with heart failure', 'Patients With Advanced Heart Failure', '71 women and 79 men', 'men and women with heart failure']",['palliative care intervention'],"['Kansas City Cardiomyopathy Questionnaire score', 'Quality of Life and Clinical Outcomes', 'baseline Kansas City Cardiomyopathy Questionnaire', 'Rates of death and rehospitalization', 'quality of life', 'change in Kansas City Cardiomyopathy Questionnaire score', ""women's quality-of-life score"", 'symptom burden and poorer quality of life', 'Functional Assessment of Chronic Illness Therapy-Palliative Care scale', 'clinical characteristics and quality-of-life metrics']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]",71.0,0.195253,"Rates of death and rehospitalization, as well as the composite end point, were similar between treated and untreated women and men.
","[{'ForeName': 'Lauren K', 'Initials': 'LK', 'LastName': 'Truby', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, VA (C.O.).'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Fiuzat', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Stebbins', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Coles', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Chetan B', 'Initials': 'CB', 'LastName': 'Patel', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Bradi', 'Initials': 'B', 'LastName': 'Granger', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Pagidipati', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rymer', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Lowenstern', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tulsky', 'Affiliation': ""Division of Palliative Medicine, Department of Medicine, Dana Farber Cancer Institute, Brigham and Women's Hospital, Boston, MA (J.T.).""}, {'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Rogers', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.119.006134']
141,30632104,The Influence of Patient Race and Activation on Pain Management in Advanced Lung Cancer: a Randomized Field Experiment.,"BACKGROUND


Pain management racial disparities exist, yet it is unclear whether disparities exist in pain management in advanced cancer.
OBJECTIVE


To examine the effect of race on physicians' pain assessment and treatment in advanced lung cancer and the moderating effect of patient activation.
DESIGN


Randomized field experiment. Physicians consented to see two unannounced standardized patients (SPs) over 18 months. SPs portrayed 4 identical roles-a 62-year-old man with advanced lung cancer and uncontrolled pain-differing by race (black or white) and role (activated or typical). Activated SPs asked questions, interrupted when necessary, made requests, and expressed opinions.
PARTICIPANTS


Ninety-six primary care physicians (PCPs) and oncologists from small cities, and suburban and rural areas of New York, Indiana, and Michigan. Physicians' mean age was 52 years (SD = 27.17), 59% male, and 64% white.
MAIN MEASURES


Opioids prescribed (or not), total daily opioid doses (in oral morphine equivalents), guideline-concordant pain management, and pain assessment.
KEY RESULTS


SPs completed 181 covertly audio-recorded visits that had complete data for the model covariates. Physicians detected SPs in 15% of visits. Physicians prescribed opioids in 71% of visits; 38% received guideline-concordant doses. Neither race nor activation was associated with total opioid dose or guideline-concordant pain management, and there were no interaction effects (p > 0.05). Activation, but not race, was associated with improved pain assessment (ẞ, 0.46, 95% CI 0.18, 0.74). In post hoc analyses, oncologists (but not PCPs) were less likely to prescribe opioids to black SPs (OR 0.24, 95% CI 0.07, 0.81).
CONCLUSIONS


Neither race nor activation was associated with opioid prescribing; activation was associated with better pain assessment. In post hoc analyses, oncologists were less likely to prescribe opioids to black male SPs than white male SPs; PCPs had no racial disparities. In general, physicians may be under-prescribing opioids for cancer pain.
TRIAL REGISTRATION


NCT01501006.",2019,"Activation, but not race, was associated with improved pain assessment (ẞ, 0.46, 95% CI 0.18, 0.74).","['Advanced Lung Cancer', 'advanced lung cancer', '62-year-old man with advanced lung cancer and uncontrolled pain-differing by race (black or white) and role (activated or typical', ""Physicians' mean age was 52\xa0years (SD\u2009=\u200927.17), 59% male, and 64% white.\nMAIN MEASURES\n\n\nOpioids prescribed (or not), total daily opioid doses (in oral morphine equivalents), guideline-concordant pain management, and pain assessment"", 'Ninety-six primary care physicians (PCPs) and oncologists from small cities, and suburban and rural areas of New York, Indiana, and Michigan']",[],"['total opioid dose or guideline-concordant pain management', 'pain assessment']","[{'cui': 'C4524268', 'cui_str': 'Advanced lung cancer'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0747149', 'cui_str': 'Uncontrolled pain (finding)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0030198', 'cui_str': 'Nociception Tests'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0033131', 'cui_str': 'Primary Care Physicians'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0021206', 'cui_str': 'Indiana'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0030198', 'cui_str': 'Nociception Tests'}]",,0.0514845,"Activation, but not race, was associated with improved pain assessment (ẞ, 0.46, 95% CI 0.18, 0.74).","[{'ForeName': 'Cleveland G', 'Initials': 'CG', 'LastName': 'Shields', 'Affiliation': 'Center for Cancer Research, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Griggs', 'Affiliation': 'Department of Internal Medicine, Hematology/ Oncology Division, and Health Management and Policy, University of Michigan School of Medicine, Ann Arbor, MI, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Fiscella', 'Affiliation': 'Center for Communication and Disparities Research, University of Rochester School of Medicine, Rochester, NY, USA.'}, {'ForeName': 'Cezanne M', 'Initials': 'CM', 'LastName': 'Elias', 'Affiliation': 'Human Development & Family Studies, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Christ', 'Affiliation': 'Human Development & Family Studies, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Colbert', 'Affiliation': 'Department of Biostatistics, University of Michigan School of Medicine, Ann Arbor, MI, USA.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Henry', 'Affiliation': 'Department of Internal Medicine, University of California Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Beth G', 'Initials': 'BG', 'LastName': 'Hoh', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine, Rochester, NY, USA.'}, {'ForeName': 'Haslyn E R', 'Initials': 'HER', 'LastName': 'Hunte', 'Affiliation': 'School of Public Health, Department of Social and Behavioral Sciences, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Marshall', 'Affiliation': 'Human Development & Family Studies, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Supriya Gupta', 'Initials': 'SG', 'LastName': 'Mohile', 'Affiliation': 'James P Wilmot Cancer Center, University of Rochester School of Medicine, Rochester, NY, USA.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Plumb', 'Affiliation': 'Center for Communication and Disparities Research, University of Rochester School of Medicine, Rochester, NY, USA.'}, {'ForeName': 'Mohamedtaki A', 'Initials': 'MA', 'LastName': 'Tejani', 'Affiliation': 'James P Wilmot Cancer Center, University of Rochester School of Medicine, Rochester, NY, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Venuti', 'Affiliation': 'Center for Communication and Disparities Research, University of Rochester School of Medicine, Rochester, NY, USA.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Epstein', 'Affiliation': 'Center for Communication and Disparities Research, University of Rochester School of Medicine, Rochester, NY, USA. ronald_epstein@urmc.rochester.edu.'}]",Journal of general internal medicine,['10.1007/s11606-018-4785-z']
142,31863094,Residual Adrenal Function in Autoimmune Addison's Disease-Effect of Dual Therapy With Rituximab and Depot Tetracosactide.,"CONTEXT


In autoimmune Addison's disease (AAD), exogenous glucocorticoid (GC) therapy is an imperfect substitute for physiological GC secretion. Patients on long-term steroid replacement have increased morbidity, reduced life expectancy, and poorer quality of life.
OBJECTIVE


The objective of this article is to restore adrenocortical steroidogenic function in recent-onset AAD.
DESIGN


An open-label, multicenter trial of immunotherapy and trophic stimulation in new-onset AAD was conducted. Serial measurement of serum and urine corticosteroids at baseline and throughout a 72-week follow-up period was performed.
SETTING


This study was conducted at the.
endocrine departments and clinical research facilities at 5 UK tertiary centers.
PATIENTS


Thirteen participants (9 female, 4 male; age 19-64 years) were included with AAD confirmed by high adrenocorticotropin, low circulating cortisol (basal < 100 nmol/L or post-tetracosactide < 300 nmol/L), and positive serum 21-hydroxylase antibodies.
INTERVENTION


All participants received dual therapy with B-lymphocyte-depleting immunotherapy (rituximab 1 g given twice) and repeated depot tetracosactide (1 mg on alternate days for 12 weeks).
MAIN OUTCOME MEASURE


Restoration of normal GC secretion (stimulated cortisol > 550 nmol/L) at week 48 was the main outcome measure.
RESULTS


Ten of 13 (77%) participants had detectable stimulated serum cortisol (26-265 nmol/L) at trial entry. Following intervention, 7 of 13 (54%) had an increase in stimulated cortisol measurement, with a peak response of 325 nmol/L at week 18 in 1 participant. Increased steroid metabolites, assayed by urine gas chromatography-mass spectrometry at week 12 and week 48, was detected in 8 of 13 (62%) individuals, reflecting an increase in endogenous steroidogenesis. Four of 13 had residual adrenal function at 72 weeks.
CONCLUSION


Combined treatment with rituximab and depot tetracosactide did not restore normal adrenal function. Nevertheless, adrenocortical plasticity is demonstrated in some patients, and this has the potential to be exploited to improve adrenal function.",2020,Ten of 13 (77%) participants had detectable stimulated serum cortisol (26-265 nmol/L) at trial entry.,"['Ten of 13 (77%) participants had detectable stimulated serum cortisol (26-265 nmol/L) at trial entry', 'endocrine departments and clinical research facilities at 5 UK tertiary centers', 'Thirteen participants (9 female, 4 male; age 19-64 years) were included with AAD confirmed by high adrenocorticotropin, low circulating cortisol (basal < 100 nmol/L or post-tetracosactide < 300 nmol/L), and positive serum 21-hydroxylase antibodies']","['Rituximab and Depot Tetracosactide', 'glucocorticoid (GC) therapy', 'immunotherapy and trophic stimulation', 'dual therapy with B-lymphocyte-depleting immunotherapy (rituximab 1 g given twice) and repeated depot tetracosactide', 'rituximab and depot tetracosactide']","['endogenous steroidogenesis', 'Restoration of normal GC secretion (stimulated cortisol > 550 nmol/L', 'morbidity, reduced life expectancy, and poorer quality of life', 'stimulated cortisol measurement', 'residual adrenal function', 'normal adrenal function', 'Increased steroid metabolites, assayed by urine gas chromatography-mass spectrometry']","[{'cui': 'C0729349', 'cui_str': 'Serum cortisol (substance)'}, {'cui': 'C0439282', 'cui_str': 'nM'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0201835', 'cui_str': 'Adrenocorticotropic hormone measurement (procedure)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0010192', 'cui_str': 'tetracosactide'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0804954', 'cui_str': 'Steroid 21-monooxygenase antibody'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0010192', 'cui_str': 'tetracosactide'}, {'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}]","[{'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}, {'cui': 'C0439282', 'cui_str': 'nM'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0034380'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0024868', 'cui_str': 'Spectrum Analysis, Mass-Gas Chromatography'}]",,0.0287794,Ten of 13 (77%) participants had detectable stimulated serum cortisol (26-265 nmol/L) at trial entry.,"[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Napier', 'Affiliation': 'Institute of Genetic Medicine, International Centre for Life, Newcastle University, UK.'}, {'ForeName': 'Earn H', 'Initials': 'EH', 'LastName': 'Gan', 'Affiliation': 'Institute of Genetic Medicine, International Centre for Life, Newcastle University, UK.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Mitchell', 'Affiliation': 'Institute of Genetic Medicine, International Centre for Life, Newcastle University, UK.'}, {'ForeName': 'Lorna C', 'Initials': 'LC', 'LastName': 'Gilligan', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'D Aled', 'Initials': 'DA', 'LastName': 'Rees', 'Affiliation': 'Neuroscience and Mental Health Research Institute, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Moran', 'Affiliation': ""University of Cambridge Metabolic Research Laboratories, Wellcome Trust-MRC, Institute of Metabolic Science, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Krishna', 'Initials': 'K', 'LastName': 'Chatterjee', 'Affiliation': ""University of Cambridge Metabolic Research Laboratories, Wellcome Trust-MRC, Institute of Metabolic Science, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Bijay', 'Initials': 'B', 'LastName': 'Vaidya', 'Affiliation': 'Royal Devon & Exeter Hospital, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'R Andrew', 'Initials': 'RA', 'LastName': 'James', 'Affiliation': 'Institute of Genetic Medicine, International Centre for Life, Newcastle University, UK.'}, {'ForeName': 'Yaasir', 'Initials': 'Y', 'LastName': 'Mamoojee', 'Affiliation': 'Institute of Genetic Medicine, International Centre for Life, Newcastle University, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Ashwell', 'Affiliation': 'The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Arlt', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Simon H S', 'Initials': 'SHS', 'LastName': 'Pearce', 'Affiliation': 'Institute of Genetic Medicine, International Centre for Life, Newcastle University, UK.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz287']
143,31417163,Antibody dynamics in Japanese paediatric patients with influenza A infection treated with neuraminidase inhibitors in a randomised trial.,"Neuraminidase inhibitors (NAIs) complement influenza virus infection management by helping to clear virus, alleviate symptoms, and reduce transmission. In a previous randomised study, we examined the effect of 4 NAIs on virus clearance and influenza symptoms in Japanese paediatric patients. In this second analysis, we examined the effects of NAI treatment on antibody responses and virus clearance, and the relationships between antibody responses and patients' infection histories (previous infection; asymptomatic infection via household members of same virus type/subtype; vaccination), and between infection histories and viral kinetics. Haemagglutination inhibition (HI) antibody responses produced HI titres ≥40 by Day 14 of NAI treatment, in parallel with virus clearance (trend test P = 0.001). Comparing patients with and without influenza infection histories (directly or asymptomatic infection via household members) showed that infection history had a marked positive effect on HI antibody responses in patients vaccinated before the current influenza season (before enrolment). Current virus clearance was significantly faster in patients previously infected with the same virus type/subtype than in those not previously infected, and clearance pattern depended on the NAI. Assessment of anti-influenza effects of antiviral drugs and vaccines should consider virus and antibody dynamics in response to vaccination and natural infection histories.",2019,"Current virus clearance was significantly faster in patients previously infected with the same virus type/subtype than in those not previously infected, and clearance pattern depended on the NAI.","['Japanese paediatric patients', 'patients with and without influenza infection histories (directly or asymptomatic infection via household members', ""patients' infection histories (previous infection; asymptomatic infection via household members of same virus type/subtype; vaccination"", 'Japanese paediatric patients with influenza']","['4 NAIs', 'neuraminidase inhibitors', 'Neuraminidase inhibitors (NAIs', 'NAI treatment']","['HI antibody responses', 'Current virus clearance', 'Haemagglutination inhibition (HI) antibody responses produced HI titres ≥40', 'virus clearance and influenza symptoms', 'antibody responses and virus clearance']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0275522', 'cui_str': 'Subclinical Infections'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0680022', 'cui_str': 'Member of (attribute)'}, {'cui': 'C0449572', 'cui_str': 'Virus type (attribute)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C1311702', 'cui_str': 'thallium-doped sodium iodide'}, {'cui': 'C0027803', 'cui_str': 'N-Acylneuraminate Glycohydrolases'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0042776', 'cui_str': 'Virus'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0202353,"Current virus clearance was significantly faster in patients previously infected with the same virus type/subtype than in those not previously infected, and clearance pattern depended on the NAI.","[{'ForeName': 'Nobuo', 'Initials': 'N', 'LastName': 'Hirotsu', 'Affiliation': 'Hirotsu Clinic, Kawasaki, Japan. non@hirotsu.ptu.jp.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Saisho', 'Affiliation': 'Shionogi & Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Hasegawa', 'Affiliation': 'Shionogi & Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Mitsutaka', 'Initials': 'M', 'LastName': 'Kitano', 'Affiliation': 'Shionogi & Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Shishido', 'Affiliation': 'Shionogi & Co., Ltd., Osaka, Japan.'}]",Scientific reports,['10.1038/s41598-019-47884-0']
144,30703258,A Phase 1 Randomized Study of Single Intravenous Infusions of the Novel Nitroxyl Donor BMS-986231 in Healthy Volunteers.,"Nitroxyl (HNO) is a reactive nitrogen molecule that has potential therapeutic benefits for patients with acute heart failure. The results of the first-in-human study for BMS-986231, a novel HNO donor, are reported. The aim of this sequential cohort study was to evaluate the safety, tolerability, and pharmacokinetic profile of BMS-986231 after 24- and 48-hour intravenous infusions in healthy volunteers. Eighty subjects were randomized and dosed. Seven cohorts (stratum A) received BMS-986231 0.1, 0.33, 1, 3, 5, 10, and 15 μg/kg/min or placebo, infused over 24 hours. An additional cohort (stratum B) received 10 μg/kg/min or placebo, infused over 48 hours. Adverse events (AEs) were reported for 30 days after completion of infusion. Blood/urine samples were collected at regular intervals; other parameters (blood pressure, heart rate/rhythm, cardiac index) were also assessed. Headaches were the most commonly reported drug-related AE (48%) in those who received BMS-986231, although their severity was reduced by hydration. No other significant drug-related AEs were noted. BMS-986231 was associated with dose-dependent and well-tolerated reductions in systolic and diastolic blood pressure versus baseline; cardiac index, as measured noninvasively, was increased. BMS-986231 had no clinically significant effect on heart rate/rhythm or laboratory parameters. Its mean elimination half-life was 0.7-2.5 hours. BMS-986231 was safe and well-tolerated for up to 24 hours (15 μg/kg/min) or 48 hours (10 μg/kg/min), with a favorable hemodynamic profile observed. Ongoing studies continue to evaluate the potential benefit of BMS-986231 in patients with acute heart failure.",2019,"BMS-986231 was associated with dose-dependent and well-tolerated reductions in systolic and diastolic blood pressure versus baseline; cardiac index, as measured noninvasively, was increased.","['patients with acute heart failure', 'Healthy Volunteers', 'healthy volunteers', 'Eighty subjects']","['BMS-986231', 'placebo', 'Novel Nitroxyl Donor BMS-986231', 'Nitroxyl (HNO', '10\xa0μg/kg/min or placebo']","['heart rate/rhythm or laboratory parameters', 'Blood/urine samples', 'safety, tolerability, and pharmacokinetic profile', 'parameters (blood pressure, heart rate/rhythm, cardiac index', 'Headaches', 'systolic and diastolic blood pressure versus baseline; cardiac index', 'safe and well-tolerated', 'Adverse events (AEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0068882', 'cui_str': 'HNO compound'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005768'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",80.0,0.203955,"BMS-986231 was associated with dose-dependent and well-tolerated reductions in systolic and diastolic blood pressure versus baseline; cardiac index, as measured noninvasively, was increased.","[{'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Cowart', 'Affiliation': 'Cardioxyl Pharmaceuticals, Inc., Chapel Hill, NC, USA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Venuti', 'Affiliation': 'Cardioxyl Pharmaceuticals, Inc., Chapel Hill, NC, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Lynch', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Durham, NC, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Guptill', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Durham, NC, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Noveck', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Durham, NC, USA.'}, {'ForeName': 'Shi Yin', 'Initials': 'SY', 'LastName': 'Foo', 'Affiliation': 'Cardioxyl Pharmaceuticals, Inc., Chapel Hill, NC, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1364']
145,32251031,Intrathecal Morphine versus Intrathecal Hydromorphone for Analgesia after Cesarean Delivery: A Randomized Clinical Trial.,"BACKGROUND


Intrathecal opioids are routinely administered during spinal anesthesia for postcesarean analgesia. The effectiveness of intrathecal morphine for postcesarean analgesia is well established, and the use of intrathecal hydromorphone is growing. No prospective studies have compared the effectiveness of equipotent doses of intrathecal morphine versus intrathecal hydromorphone as part of a multimodal analgesic regimen for postcesarean analgesia. The authors hypothesized that intrathecal morphine would result in superior analgesia compared with intrathecal hydromorphone 24 h after delivery.
METHODS


In this single-center, double-blinded, randomized trial, 138 parturients undergoing scheduled cesarean delivery were randomized to receive 150 µg of intrathecal morphine or 75 µg of intrathecal hydromorphone as part of a primary spinal anesthetic and multimodal analgesic regimen; 134 parturients were included in the analysis. The primary outcome was the numerical rating scale score for pain with movement 24 h after delivery. Static and dynamic pain scores, nausea, pruritus, degree of sedation, and patient satisfaction were assessed every 6 h for 36 h postpartum. Total opioid consumption was recorded.
RESULTS


There was no significant difference in pain scores with movement at 24 h (intrathecal hydromorphone median [25th, 75th] 4 [3, 5] and intrathecal morphine 3 [2, 4.5]) or at any time point (estimated difference, 0.5; 95% CI, 0 to 1; P = 0.139). Opioid received in the first 24 h did not differ between groups (median [25th, 75th] oral morphine milligram equivalents for intrathecal hydromorphone 30 [7.5, 45.06] vs. intrathecal morphine 22.5 [14.0, 37.5], P = 0.769). From Kaplan-Meier analysis, the median time to first opioid request was 5.4 h for hydromorphone and 12.1 h for morphine (log-rank test P = 0.200).
CONCLUSIONS


Although the hypothesis was that intrathecal morphine would provide superior analgesia to intrathecal hydromorphone, the results did not confirm this. At the doses studied, both intrathecal morphine and intrathecal hydromorphone provide effective postcesarean analgesia when combined with a multimodal analgesia regimen.",2020,"There was no significant difference in pain scores with movement at 24 h (intrathecal hydromorphone median [25th, 75th] 4 [3, 5] and intrathecal morphine 3 [2, 4.5]) or at any time point (estimated difference, 0.5; 95% CI, 0 to 1; P = 0.139).","['Analgesia after Cesarean Delivery', '134 parturients were included in the analysis', 'women receiving cesarean delivery using pain score at 24 h as the primary outcome', '138 parturients undergoing scheduled cesarean delivery', 'postcesarean analgesia']","['intrathecal hydromorphone as part of a primary spinal anesthetic and multimodal analgesic regimen', 'Intrathecal Morphine', 'Intrathecal Hydromorphone', 'hydromorphone', 'intrathecal hydromorphone', 'morphine', 'Intrathecal opioids', 'intrathecal morphine and intrathecal hydromorphone', 'intrathecal hydromorphone and intrathecal morphine', 'intrathecal morphine']","['median time to first opioid request', 'Static and dynamic pain scores, nausea, pruritus, degree of sedation, and patient satisfaction', 'numerical rating scale score for pain with movement 24 h after delivery', 'breakthrough analgesic requirements', 'superior analgesia', 'pain scores', 'Total opioid consumption']","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",138.0,0.536156,"There was no significant difference in pain scores with movement at 24 h (intrathecal hydromorphone median [25th, 75th] 4 [3, 5] and intrathecal morphine 3 [2, 4.5]) or at any time point (estimated difference, 0.5; 95% CI, 0 to 1; P = 0.139).","[{'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Sharpe', 'Affiliation': 'From the Departments of Anesthesiology and Peri-operative Medicine (E.E.S., R.J.M., K.W.A., D.A.O., R.L.J., A.K.J., A.D.N., H.P.S.) Obstetrics and Gynecology (V.E.T.) Health Sciences Research (D.R.S.), Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Rochelle J', 'Initials': 'RJ', 'LastName': 'Molitor', 'Affiliation': ''}, {'ForeName': 'Katherine W', 'Initials': 'KW', 'LastName': 'Arendt', 'Affiliation': ''}, {'ForeName': 'Vanessa E', 'Initials': 'VE', 'LastName': 'Torbenson', 'Affiliation': ''}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Olsen', 'Affiliation': ''}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Darrell R', 'Initials': 'DR', 'LastName': 'Schroeder', 'Affiliation': ''}, {'ForeName': 'Adam K', 'Initials': 'AK', 'LastName': 'Jacob', 'Affiliation': ''}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Niesen', 'Affiliation': ''}, {'ForeName': 'Hans P', 'Initials': 'HP', 'LastName': 'Sviggum', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003283']
146,31837264,Sotagliflozin Decreases Postprandial Glucose and Insulin Concentrations by Delaying Intestinal Glucose Absorption.,"CONTEXT


The effect of sotagliflozin (a dual sodium-glucose cotransporter [SGLT] 2 and SGLT1 inhibitor) on intestinal glucose absorption has not been investigated in humans.
OBJECTIVE


To measure rate of appearance of oral glucose (RaO) using a dual glucose tracer method following standardized mixed meals taken after single sotagliflozin or canagliflozin doses.
SETTING


Clinical research organization.
DESIGN AND PARTICIPANTS


In a double-blind, 3-period crossover study (NCT01916863), 24 healthy participants were randomized to 2 cohorts of 12 participants. Within each cohort, participants were randomly assigned single oral doses of either sotagliflozin 400 mg, canagliflozin 300 mg, or placebo on each of test days 1, 8, and 15. On test days, Cohort 1 had breakfast containing [6,6-2H2] glucose 0.25 hours postdose and lunch containing [1-2H1] glucose 5.25 hours postdose; Cohort 2 had breakfast containing no labeled glucose 0.25 hours postdose and lunch containing [6,6-2H2] glucose 4.25 hours postdose. All participants received a 10- to 15-hour continuous [U-13C6] glucose infusion starting 5 hours before their first [6,6-2H2] glucose-containing meal.
MAIN OUTCOME


RaO, postprandial glucose (PPG), and postprandial insulin.
RESULTS


Sotagliflozin and canagliflozin decreased area under the curve (AUC)0-1 hour and/or AUC0-2 hours for RaO, PPG, and insulin after breakfast and/or the 4.25-hour postdose lunch (P < .05 versus placebo). After the 5.25-hour postdose lunch, sotagliflozin lowered RaO AUC0-1 hour and PPG AUC0-5 hours versus both placebo and canagliflozin (P < .05).
CONCLUSIONS


Sotagliflozin delayed and blunted intestinal glucose absorption after meals, resulting in lower PPG and insulin levels, likely due to prolonged local inhibition of intestinal SGLT1 that persisted for ≥5 hours after dosing.",2020,"RESULTS


Sotagliflozin and canagliflozin decreased AUC0-1 hour and/or AUC0-2 hours for RaO, PPG, and insulin after breakfast and/or the 4.25-hour postdose lunch (P<0.05 versus placebo).","['humans', '24 healthy participants were randomized to two cohorts of 12 participants']","['breakfast containing [6,6-2H2] glucose 0.25 hours postdose and lunch containing [1-2H1] glucose 5.25 hours postdose; Cohort 2 had breakfast containing no labeled glucose 0.25 hours postdose and lunch containing [6,6-2H2] glucose 4.25 hours postdose', 'sotagliflozin (a dual sodium-glucose cotransporter [SGLT]2 and SGLT1 inhibitor', 'Sotagliflozin', 'placebo and canagliflozin', '10-15-hour continuous [U-13C6] glucose infusion starting 5 hours before their first [6,6-2H2] glucose-containing meal', 'sotagliflozin 400 mg, canagliflozin 300 mg, or placebo']","['RaO, postprandial glucose (PPG), and postprandial insulin', 'blunted intestinal glucose absorption', 'Postprandial Glucose and Insulin Concentrations', 'lower PPG and insulin levels', 'rate of appearance of oral glucose (RaO']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C3896939'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1442467', 'cui_str': '5 hours (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3556568', 'cui_str': 'canagliflozin 300 MG [Invokana]'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0049716', 'cui_str': 'thioGDP'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]",24.0,0.178065,"RESULTS


Sotagliflozin and canagliflozin decreased AUC0-1 hour and/or AUC0-2 hours for RaO, PPG, and insulin after breakfast and/or the 4.25-hour postdose lunch (P<0.05 versus placebo).","[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Powell', 'Affiliation': 'Lexicon Pharmaceuticals, Inc, The Woodlands, Texas.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Zambrowicz', 'Affiliation': 'Lexicon Pharmaceuticals, Inc, The Woodlands, Texas.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Morrow', 'Affiliation': 'ProSciento, Inc, Chula Vista, California.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Beysen', 'Affiliation': 'ProSciento, Inc, Chula Vista, California.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Hompesch', 'Affiliation': 'ProSciento, Inc, Chula Vista, California.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Turner', 'Affiliation': 'Pliant Therapeutics, South San Francisco, California.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hellerstein', 'Affiliation': 'University of California, Berkeley, California.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Banks', 'Affiliation': 'Lexicon Pharmaceuticals, Inc, The Woodlands, Texas.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Strumph', 'Affiliation': 'Lexicon Pharmaceuticals, Inc, The Woodlands, Texas.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Lapuerta', 'Affiliation': 'Lexicon Pharmaceuticals, Inc, The Woodlands, Texas.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz258']
147,30421335,Medically Tailored Meal Delivery for Diabetes Patients with Food Insecurity: a Randomized Cross-over Trial.,"BACKGROUND


Food insecurity, defined as inconsistent food access owing to cost, leads to poor health.
OBJECTIVE


To test whether a medically tailored meal delivery program improved dietary quality in individuals with type 2 diabetes and food insecurity.
DESIGN


Randomized cross-over clinical trial.
PARTICIPANTS


Forty-four adults with diabetes, hemoglobin A1c > 8.0%, and food insecurity (defined as at least one positive item on the two-item ""Hunger Vital Sign"").
INTERVENTION


In the Community Servings: Food as Medicine for Diabetes cross-over clinical trial (NCT02426138), conducted from June 2015 to July 2017, we randomly assigned the order of ""on-meals"" (home delivery of 10 meals/week for 12 weeks delivered by Community Servings, a non-profit organization) and ""off-meals"" (12 weeks usual care and a Choose MyPlate healthy eating brochure) periods.
MAIN MEASURES


The primary outcome was Healthy Eating Index 2010 score (HEI), assessed by three 24-h food recalls in both periods. Higher HEI score (range 0-100; clinically significant difference 5) represents better dietary quality. Secondary outcomes included food insecurity and self-reported hypoglycemia.
KEY RESULTS


Mean ""on-meal"" HEI score was 71.3 (SD 7.5) while mean ""off-meal"" HEI score was 39.9 (SD 7.8) (difference 31.4 points, p < 0.0001). Participants experienced improvements in almost all sub-categories of HEI score, with increased consumption of vegetables, fruits, and whole grains and decreased solid fats, alcohol, and added sugar consumption. Participants also reported lower food insecurity (42% ""on-meal"" vs. 62% ""off-meal,"" p = 0.047), less hypoglycemia (47% ""on-meal"" vs. 64% ""off-meal,"" p = 0.03), and fewer days where mental health interfered with quality of life (5.65 vs. 9.59 days out of 30, p = 0.03).
CONCLUSIONS


For food-insecure individuals with diabetes, medically tailored meals improved dietary quality and food insecurity and reduced hypoglycemia. Longer-term studies should evaluate effects on diabetes control (e.g., hemoglobin A1c) and patient-reported outcomes (e.g., well-being).",2019,"CONCLUSIONS


For food-insecure individuals with diabetes, medically tailored meals improved dietary quality and food insecurity and reduced hypoglycemia.","['individuals with type 2 diabetes and food insecurity', 'June 2015 to July 2017', 'Diabetes Patients with Food Insecurity', 'Forty-four adults with diabetes, hemoglobin A1c\u2009>\u20098.0%, and food insecurity (defined as at least one positive item on the two-item ""Hunger Vital Sign']","['medically tailored meal delivery program', 'on-meals"" (home delivery of 10 meals/week for 12\xa0weeks delivered by Community Servings, a non-profit organization) and ""off-meals"" (12\xa0weeks usual care and a Choose MyPlate healthy eating brochure) periods']","['Higher HEI score', 'mental health interfered with quality of life', 'lower food insecurity', 'hypoglycemia', 'mean ""off-meal"" HEI score', 'dietary quality', 'HEI score, with increased consumption of vegetables, fruits, and whole grains and decreased solid fats, alcohol, and added sugar consumption', 'Mean ""on-meal"" HEI score', 'food insecurity and self-reported hypoglycemia', 'dietary quality and food insecurity and reduced hypoglycemia', 'Healthy Eating Index 2010 score (HEI']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3494174', 'cui_str': 'Food Insecurity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0518766'}]","[{'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0029247', 'cui_str': 'Nonprofit Organizations'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0521102', 'cui_str': 'Interferes with (contextual qualifier) (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3494174', 'cui_str': 'Food Insecurity'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}]",44.0,0.111009,"CONCLUSIONS


For food-insecure individuals with diabetes, medically tailored meals improved dietary quality and food insecurity and reduced hypoglycemia.","[{'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Berkowitz', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA, USA. seth_berkowitz@med.unc.edu.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Delahanty', 'Affiliation': 'Diabetes Unit, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Terranova', 'Affiliation': 'Community Servings, INC, Jamaica Plain, MA, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Steiner', 'Affiliation': 'Diabetes Unit, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Melanie P', 'Initials': 'MP', 'LastName': 'Ruazol', 'Affiliation': 'Diabetes Unit, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Roshni', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Diabetes Unit, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Naysha N', 'Initials': 'NN', 'LastName': 'Shahid', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Wexler', 'Affiliation': 'Diabetes Unit, Massachusetts General Hospital, Boston, MA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-018-4716-z']
148,32321389,Evaluation of Proactive Community Case Detection to Increase Help Seeking for Mental Health Care: A Pragmatic Randomized Controlled Trial.,"OBJECTIVE


The Community Informant Detection Tool (CIDT) is a vignette- and picture-based method of proactive case detection to promote help seeking for persons with depression, psychosis, alcohol use disorder, and epilepsy. The authors evaluated the effectiveness of the CIDT to increase help-seeking behavior in rural Nepal, where a district mental health care plan was being implemented.
METHODS


Twenty-four health facilities were randomly assigned to one of two methods for training their all-female cadre of community health volunteers: standard training or standard training that included the CIDT. The authors compared the number of patients with depression, psychosis, alcohol use disorder, and epilepsy who were registered in the routine health information system prior to and 6 months after the training.
RESULTS


At health facilities where volunteers received CIDT training, 309 patients were registered as having depression, psychosis, alcohol use disorder, or epilepsy, compared with 182 patients at facilities where volunteers received standard training. The median number of patients registered was 47% greater at facilities where CIDT training was included (24 patients) than at facilities with standard training (16 patients) (p=0.04, r=0.42). The difference in the number of registered patients remained significant when the analysis factored in the population catchment (N=18 patients [CIDT] versus N=14 [standard] per 10,000 population; p=0.05, r=0.40).
CONCLUSIONS


The median number of patients registered as having a mental illness was 47% greater at primary care facilities in which community health volunteers used the CIDT than at facilities where volunteers received standard training. Proactive case finding holds promise for increasing help seeking for mental health care.",2020,The median number of patients registered as having a mental illness was 47% greater at primary care facilities in which community health volunteers used the CIDT than at facilities where volunteers received standard training.,"['309 patients were registered as having depression, psychosis, alcohol use disorder, or epilepsy, compared with 182 patients at facilities where volunteers received', 'Twenty-four health facilities', 'Mental Health Care', 'patients with depression, psychosis, alcohol use disorder, and epilepsy who were registered in the routine health information system prior to and 6 months after the training']","['CIDT training', 'training their all-female cadre of community health volunteers: standard training or standard training that included the CIDT', 'standard training', 'CIDT', 'Proactive Community Case Detection', 'Community Informant Detection Tool (CIDT']","['median number of patients registered', 'median number of patients registered as having a mental illness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0679918', 'cui_str': 'Health Information Systems'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0585825', 'cui_str': 'Patient registered'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]",309.0,0.0371716,The median number of patients registered as having a mental illness was 47% greater at primary care facilities in which community health volunteers used the CIDT than at facilities where volunteers received standard training.,"[{'ForeName': 'Mark J D', 'Initials': 'MJD', 'LastName': 'Jordans', 'Affiliation': ""Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London (Jordans, Lund); Transcultural Psychosocial Organization (TPO) Nepal, Kathmandu (Jordans, Luitel, Kohrt); Alan J. Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa (Lund); Department of Psychiatry, George Washington University, Washington, D.C. (Kohrt).""}, {'ForeName': 'Nagendra P', 'Initials': 'NP', 'LastName': 'Luitel', 'Affiliation': ""Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London (Jordans, Lund); Transcultural Psychosocial Organization (TPO) Nepal, Kathmandu (Jordans, Luitel, Kohrt); Alan J. Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa (Lund); Department of Psychiatry, George Washington University, Washington, D.C. (Kohrt).""}, {'ForeName': 'Crick', 'Initials': 'C', 'LastName': 'Lund', 'Affiliation': ""Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London (Jordans, Lund); Transcultural Psychosocial Organization (TPO) Nepal, Kathmandu (Jordans, Luitel, Kohrt); Alan J. Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa (Lund); Department of Psychiatry, George Washington University, Washington, D.C. (Kohrt).""}, {'ForeName': 'Brandon A', 'Initials': 'BA', 'LastName': 'Kohrt', 'Affiliation': ""Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London (Jordans, Lund); Transcultural Psychosocial Organization (TPO) Nepal, Kathmandu (Jordans, Luitel, Kohrt); Alan J. Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa (Lund); Department of Psychiatry, George Washington University, Washington, D.C. (Kohrt).""}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201900377']
149,32319168,"Efficacy and safety of evogliptin treatment in patients with type 2 diabetes: A multicentre, active-controlled, randomized, double-blind study with open-label extension (the EVERGREEN study).","AIM


To investigate the efficacy and safety of evogliptin compared with linagliptin in patients with type 2 diabetes.
MATERIALS AND METHODS


In this 12-week, multicentre, randomized, double-blind, active-controlled, and 12-week open-label extension study, a total of 207 patients with type 2 diabetes who had HbA1c levels of 7.0%-10.0% were randomized 1:1 to receive evogliptin 5 mg (n = 102) or linagliptin 5 mg (n = 105) daily for 12 weeks. The primary efficacy endpoint was the change from baseline HbA1c at week 12. The secondary endpoint was the change in the mean amplitude of glycaemic excursion (MAGE) assessed by continuous glucose monitoring. In the extension study conducted during the following 12 weeks, evogliptin 5 mg daily was administered to both groups: evogliptin/evogliptin group (n = 95) and linagliptin/evogliptin group (n = 92).
RESULTS


After 12 weeks of treatment, the mean change in HbA1c in the evogliptin group and in the linagliptin group was -0.85% and -0.75%, respectively. The between-group difference was -0.10% (95% CI: -0.32 to 0.11), showing non-inferiority based on a non-inferiority margin of 0.4%. The change in MAGE was -24.6 mg/dL in the evogliptin group and -16.7 mg/dL in the linagliptin group. These values were significantly lower than the baseline values in both groups. However, they did not differ significantly between the two groups. In the evogliptin/evogliptin group at week 24, HbA1c decreased by -0.94%, with HbA1c values of <7.0% in 80.2% of the patients. The incidence and types of adverse events were comparable between the two groups for 24 weeks.
CONCLUSION


In this study, the glucose-lowering efficacy of evogliptin was non-inferior to linagliptin. It was maintained at week 24 with a 0.94% reduction in HbA1c. Evogliptin therapy improved glycaemic variability without causing any serious adverse events in patients with type 2 diabetes.",2020,"In this study, the glucose-lowering efficacy of evogliptin was non-inferior to linagliptin.","['patients with T2DM', '207 patients with T2DM who had HbA1c levels of 7.0-10.0', 'patients with type 2 diabetes mellitus (T2DM', 'patients with type 2 diabetes']","['linagliptin/evogliptin', 'evogliptin 5\u2009mg (n\xa0=\xa0102) or linagliptin', 'evogliptin treatment', 'evogliptin', 'evogliptin/evogliptin', 'Evogliptin therapy', 'linagliptin']","['mean changes in HbA1c', 'Efficacy and safety', 'glycemic variability', 'efficacy and safety', 'mean amplitude of glycemic excursion (MAGE) assessed by continuous glucose monitoring', 'incidence and types of adverse events', 'change in MAGE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",207.0,0.0933063,"In this study, the glucose-lowering efficacy of evogliptin was non-inferior to linagliptin.","[{'ForeName': 'Gyuri', 'Initials': 'G', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University, Seoul, Korea.'}, {'ForeName': 'Soo', 'Initials': 'S', 'LastName': 'Lim', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Hyuk-Sang', 'Initials': 'HS', 'LastName': 'Kwon', 'Affiliation': ""Department of Internal Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Ie B', 'Initials': 'IB', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea.'}, {'ForeName': 'Kyu J', 'Initials': 'KJ', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Kangdong Kyung Hee University Hospital, Seoul, Korea.'}, {'ForeName': 'Cheol-Young', 'Initials': 'CY', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Kangbuk Samsung Hospital, Seoul, Korea.'}, {'ForeName': 'Su K', 'Initials': 'SK', 'LastName': 'Kwon', 'Affiliation': 'Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Korea.'}, {'ForeName': 'Hye S', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Keimyung University Dongsan Medical Center, Daegu, Korea.'}, {'ForeName': 'Seok W', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sin G', 'Initials': 'SG', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Korea University Anam Hospital, Seoul, Korea.'}, {'ForeName': 'Min K', 'Initials': 'MK', 'LastName': 'Moon', 'Affiliation': 'Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, Korea.'}, {'ForeName': 'Eun S', 'Initials': 'ES', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Ulsan University Hospital, College of Medicine University of Ulsan, Ulsan, Korea.'}, {'ForeName': 'Choon H', 'Initials': 'CH', 'LastName': 'Chung', 'Affiliation': 'Department of Internal Medicine, Wonju Severance Christian Hospital, Wonju, Korea.'}, {'ForeName': 'Kang S', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Eulji University Hospital, Daejeon, Korea.'}, {'ForeName': 'Mikyung', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Inje University Haeundae Paik Hospital, Busan, Korea.'}, {'ForeName': 'Dong J', 'Initials': 'DJ', 'LastName': 'Chung', 'Affiliation': 'Department of Internal Medicine, Chonnam National University Medical School, Chonnam National University Hospital, Gwangju, Korea.'}, {'ForeName': 'Chang B', 'Initials': 'CB', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea.'}, {'ForeName': 'Tae H', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul Medical Center, Seoul, Korea.'}, {'ForeName': 'Moon-Kyu', 'Initials': 'MK', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University Gumi Hospital, Gumi, South Korea.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14061']
150,32319963,Use of a Smartphone-Based Mobile App for Weight Management in Obese Minority Stroke Survivors: Pilot Randomized Controlled Trial With Open Blinded End Point.,"BACKGROUND


Minorities have an increased incidence of early-onset, obesity-related cerebrovascular disease. Unfortunately, effective weight management in this vulnerable population has significant barriers.
OBJECTIVE


Our objective was to determine the feasibility and preliminary treatment effects of a smartphone-based weight loss intervention versus food journals to monitor dietary patterns in minority stroke patients.
METHODS


Swipe out Stroke was a pilot prospective randomized controlled trial with open blinded end point. Minority stroke patients and their caregivers were screened for participation using cluster enrollment. We used adaptive randomization for assignment to a behavior intervention with (1) smartphone-based self-monitoring or (2) food journal self-monitoring. The smartphone group used Lose it! to record meals and communicate with us. Reminder messages (first 30 days), weekly summaries plus reminder messages on missed days (days 31-90), and weekly summaries only (days 91-180) were sent via push notifications. The food journal group used paper diaries. Both groups received 4 in-person visits (baseline and 30, 90, and 180 days), culturally competent counseling, and educational materials. The primary outcome was reduced total body weight.
RESULTS


We enrolled 36 stroke patients (n=23, 64% African American; n=13, 36% Hispanic), 17 in the smartphone group, and 19 in the food journal group. Mean age was 54 (SD 9) years; mean body mass index was 35.7 (SD 5.7) kg/m2; education, employment status, and family history of stroke or obesity did not differ between the groups. Baseline rates of depression (Patient Health Questionnaire-9 [PHQ-9] score median 5.5, IQR 3.0-9.5), cognitive impairment (Montreal Cognitive Assessment score median 23.5, IQR 21-26), and inability to ambulate (5/36, 14% with modified Rankin Scale score 3) were similar. In total, 25 (69%) stroke survivors completed Swipe out Stroke (13/17 in the smartphone group, 12/19 in the food journal group); 1 participant in the smartphone group died. Median weight change at 180 days was 5.7 lb (IQR -2.4 to 8.0) in the smartphone group versus 6.4 lb (IQR -2.2 to 12.5; P=.77) in the food journal group. Depression was significantly lower at 30 days in the smartphone group than in the food journal group (PHQ-9 score 2 vs 8; P=.03). Clinically relevant depression rates remained in the zero to minimal range for the smartphone group compared with mild to moderate range in the food journal group at day 90 (PHQ-9 score 3.5 vs 4.5; P=.39) and day 180 (PHQ-9 score 3 vs 6; P=.12).
CONCLUSIONS


In a population of obese minority stroke survivors, the use of a smartphone did not lead to a significant difference in weight change compared with keeping a food journal. The presence of baseline depression (19/36, 53%) was a confounding variable, which improved with app engagement. Future studies that include treatment of poststroke depression may positively influence intervention efficacy.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02531074; https://www.clinicaltrials.gov/ct2/show/NCT02531074.",2020,Depression was significantly lower at 30 days in the smartphone group than in the food journal group (PHQ-9 score 2 vs 8; P=.03).,"['Swipe out Stroke', 'Mean age was 54 (SD 9) years; mean body mass index was 35.7 (SD 5.7) kg/m2; education, employment status, and family history of stroke or obesity did not differ between the groups', 'Minority stroke patients and their caregivers', 'obese minority stroke survivors', '36 stroke patients (n=23, 64% African American; n=13, 36% Hispanic), 17 in the smartphone group, and 19 in the food journal group', 'minority stroke patients', 'Obese Minority Stroke Survivors']","['culturally competent counseling, and educational materials', 'Smartphone-Based Mobile App', 'behavior intervention with (1) smartphone-based self-monitoring or (2) food journal self-monitoring', 'smartphone-based weight loss intervention']","['Baseline rates of depression (Patient Health Questionnaire-9', 'reduced total body weight', 'weight change', 'stroke survivors completed Swipe out Stroke', 'inability to ambulate', 'Median weight change', 'depression rates', 'cognitive impairment (Montreal Cognitive Assessment score', 'Depression']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0242271', 'cui_str': 'Employment status'}, {'cui': 'C0260518', 'cui_str': 'Family history of stroke'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}]",36.0,0.176623,Depression was significantly lower at 30 days in the smartphone group than in the food journal group (PHQ-9 score 2 vs 8; P=.03).,"[{'ForeName': 'Nneka L', 'Initials': 'NL', 'LastName': 'Ifejika', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Texas Southwestern Medical Center, Dallas, TX, United States.'}, {'ForeName': 'Minal', 'Initials': 'M', 'LastName': 'Bhadane', 'Affiliation': 'College of Optometry, University of Houston, Houston, TX, United States.'}, {'ForeName': 'Chunyan C', 'Initials': 'CC', 'LastName': 'Cai', 'Affiliation': 'Division of Clinical and Translational Sciences, Department of Internal Medicine, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, TX, United States.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Noser', 'Affiliation': 'Institute for Stroke and Cerebrovascular Disease, University of Texas Health Science Center at Houston, Houston, TX, United States.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Grotta', 'Affiliation': 'Clinical Innovation and Research Institute, Memorial Hermann Hospital - Texas Medical Center, Houston, TX, United States.'}, {'ForeName': 'Sean I', 'Initials': 'SI', 'LastName': 'Savitz', 'Affiliation': 'Institute for Stroke and Cerebrovascular Disease, University of Texas Health Science Center at Houston, Houston, TX, United States.'}]",JMIR mHealth and uHealth,['10.2196/17816']
151,30575978,"Pharmacokinetics, Pharmacodynamics, and Safety of E6011, a Novel Humanized Antifractalkine (CX3CL1) Monoclonal Antibody: A Randomized, Double-Blind, Placebo-Controlled Single-Ascending-Dose Study.","E6011 is a novel humanized antifractalkine (FKN) monoclonal antibody being developed as a therapeutic target for Crohn's disease, rheumatoid arthritis, and primary biliary cholangitis. This study was a randomized, double-blind, placebo-controlled single-ascending-dose study of intravenous administration of E6011 (0.0006-10 mg/kg) in healthy Japanese adult men (n = 64). The starting dose was the minimum anticipated biological effect level (MABEL). MABEL was estimated by extrapolating results of a pharmacokinetic/pharmacodynamic (PK/PD) model relating E6011 exposure and suppression of free soluble FKN using data obtained from cynomolgus monkeys. Safety assessments consisted of monitoring and recording adverse events, laboratory tests, vital signs, intensive electrocardiograms, and chest x-rays. Blood samples to determine PK, PD (serum total FKN concentration), and serum anti-E6011 antibody were collected. Noncompartmental analysis was used to derive PK parameters. Single intravenous infusions of E6011 were safe and well tolerated in healthy subjects. Serum E6011 concentrations showed triphasic elimination. An increase in serum total FKN concentration was observed, confirming target engagement. The dose strategy for patient studies is to select regimens that will attain a minimum serum E6011 exposure of 10 μg/mL, identified as the minimum concentration needed to saturate the target-mediated elimination pathway. Model-based drug development from preclinical stage was successful in identifying dose regimens for clinical testing.",2019,Serum E6011 concentrations showed triphasic elimination.,"['healthy Japanese adult men (n = 64', 'healthy subjects']","['Placebo', 'placebo', 'Novel Humanized Antifractalkine ']","['safe and well tolerated', 'serum total FKN concentration', 'Blood samples to determine PK, PD (serum total FKN concentration), and serum anti-E6011 antibody', 'adverse events, laboratory tests, vital signs, intensive electrocardiograms, and chest x-rays', 'Pharmacokinetics, Pharmacodynamics, and Safety']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C4706052', 'cui_str': 'E6011'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022885', 'cui_str': 'Laboratory test (procedure)'}, {'cui': 'C0518766'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0039985', 'cui_str': 'Radiologic examination of chest'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",64.0,0.219295,Serum E6011 concentrations showed triphasic elimination.,"[{'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Tabuchi', 'Affiliation': 'Eisai Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Toshinori', 'Initials': 'T', 'LastName': 'Katsurabara', 'Affiliation': 'Eisai Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': 'Eisai Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Muneo', 'Initials': 'M', 'LastName': 'Aoyama', 'Affiliation': 'Eisai Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Obara', 'Affiliation': 'Eisai Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Yasuda', 'Affiliation': 'Eisai Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Tetsu', 'Initials': 'T', 'LastName': 'Kawano', 'Affiliation': 'KAN Research Institute, Inc., Kobe, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Imai', 'Affiliation': 'KAN Research Institute, Inc., Kobe, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Ieiri', 'Affiliation': 'Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Kumagai', 'Affiliation': 'Kitasato University Hospital, Sagamihara, Japan.'}]",Journal of clinical pharmacology,['10.1002/jcph.1361']
152,31030946,A Mixed Lipid Emulsion Containing Fish Oil and Its Effect on Electrophysiological Brain Maturation in Infants of Extremely Low Birth Weight: A Secondary Analysis of a Randomized Clinical Trial.,"OBJECTIVE


To assess whether parenteral nutrition for infants of extremely low birth weight using a mixed lipid emulsion that contains fish oil influences electrophysiological brain maturation.
STUDY DESIGN


The study is a prespecified secondary outcome analysis of a randomized controlled trial of 230 infants of extremely low birth weight receiving a mixed (soybean oil, medium-chain triglycerides, olive oil, and fish oil; intervention) or a soybean oil-based lipid emulsion (control). The study was conducted at a single-level IV neonatal care unit (Medical University Vienna; June 2012 to October 2015). Electrophysiological brain maturation (background activity, sleep-wake cycling, and brain maturational scores) was assessed biweekly by amplitude-integrated electroencephalography (birth to discharge).
RESULTS


A total of 317 amplitude-integrated electroencephalography measurements (intervention: n = 165; control: n = 152) from 121 (intervention: n = 63; control: n = 58) of 230 infants of the core study were available for analysis. Demographic characteristics were not significantly different. By 28 weeks of postmenstrual age, infants receiving the intervention displayed significantly greater percentages of continuous background activity. Total maturational scores and individual scores for continuity, cycling, and bandwidth were significantly greater. Maximum maturational scores were reached 2 weeks earlier in the intervention group (36.4 weeks, 35.4-37.5) compared with the control group (38.4 weeks, 37.1-42.4) (median, IQR; P < .001).
CONCLUSIONS


Using a mixed parenteral lipid emulsion that contains fish oil, we found that electrophysiological brain maturation was accelerated in infants who were preterm.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT01585935.",2019,"Total maturational scores and individual scores for continuity, cycling, and bandwidth were significantly greater.","['230 infants of extremely low birth weight receiving a', 'intervention: n\xa0=\xa063; control: n\xa0=\xa058) of 230 infants of the core study were available for analysis', 'infants of extremely low birth weight', 'infants who were preterm', 'single-level IV neonatal care unit (Medical University Vienna; June 2012 to October 2015', 'Infants of Extremely Low Birth Weight']","['mixed (soybean oil, medium-chain triglycerides, olive oil, and fish oil; intervention) or a soybean oil-based lipid emulsion (control', 'parenteral nutrition', '317 amplitude-integrated electroencephalography measurements (intervention: n\xa0=\xa0165; control: n\xa0=\xa0152) from 121', 'Mixed Lipid Emulsion Containing Fish Oil']","['electrophysiological brain maturation', 'Maximum maturational scores', 'Electrophysiological Brain Maturation', 'Electrophysiological brain maturation (background activity, sleep-wake cycling, and brain maturational scores', 'continuous background activity', 'Demographic characteristics', 'Total maturational scores and individual scores for continuity, cycling, and bandwidth']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0456065', 'cui_str': 'Infant, Extremely Low Birth Weight'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0037732', 'cui_str': 'Soybean Oil'}, {'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0456391', 'cui_str': 'Continuities (qualifier value)'}]",230.0,0.377297,"Total maturational scores and individual scores for continuity, cycling, and bandwidth were significantly greater.","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Binder', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Austria.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Giordano', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Austria.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Thanhaeuser', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Austria.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kreissl', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Austria.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Huber-Dangl', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Austria.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Longford', 'Affiliation': 'Section of Neonatal Medicine, Department of Medicine; Imperial College London, Chelsea and Westminster Campus, London, United Kingdom.'}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Haiden', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Austria.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Berger', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Repa', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Austria. Electronic address: andreas.repa@meduniwien.ac.at.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Klebermass-Schrehof', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Austria.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.03.039']
153,30543021,Efficacy and Safety of Massage for Osteoarthritis of the Knee: a Randomized Clinical Trial.,"BACKGROUND


Current treatment options for knee osteoarthritis have limited effectiveness and potentially adverse side effects. Massage may offer a safe and effective complement to the management of knee osteoarthritis.
OBJECTIVE


Examine effects of whole-body massage on knee osteoarthritis, compared to active control (light-touch) and usual care.
DESIGN


Multisite RCT assessing the efficacy of massage compared to light-touch and usual care in adults with knee osteoarthritis, with assessments at baseline and weeks 8, 16, 24, 36, and 52. Subjects in massage or light-touch groups received eight weekly treatments, then were randomized to biweekly intervention or usual care to week 52. The original usual care group continued to week 24. Analysis was performed on an intention-to-treat basis.
PARTICIPANTS


Five hundred fifty-one screened for eligibility, 222 adults with knee osteoarthritis enrolled, 200 completed 8-week assessments, and 175 completed 52-week assessments.
INTERVENTION


Sixty minutes of protocolized full-body massage or light-touch.
MAIN MEASURES


Primary: Western Ontario and McMaster Universities Arthritis Index. Secondary: visual analog pain scale, PROMIS Pain Interference, knee range of motion, and timed 50-ft walk.
KEY RESULTS


At 8 weeks, massage significantly improved WOMAC Global scores compared to light-touch (- 8.16, 95% CI = - 13.50 to - 2.81) and usual care (- 9.55, 95% CI = - 14.66 to - 4.45). Additionally, massage improved pain, stiffness, and physical function WOMAC subscale scores compared to light-touch (p < 0.001; p = 0.04; p = 0.02, respectively) and usual care (p < 0.001; p = 0.002; p = 0.002; respectively). At 52 weeks, the omnibus test of any group difference in the change in WOMAC Global from baseline to 52 weeks was not significant (p = 0.707, df = 3), indicating no significant difference in change across groups. Adverse events were minimal.
CONCLUSIONS


Efficacy of symptom relief and safety of weekly massage make it an attractive short-term treatment option for knee osteoarthritis. Longer-term biweekly dose maintained improvement, but did not provide additional benefit beyond usual care post 8-week treatment.
TRIAL REGISTRATION


clinicaltrials.gov NCT01537484.",2019,"At 8 weeks, massage significantly improved WOMAC Global scores compared to light-touch (- 8.16, 95% CI = - 13.50 to - 2.81) and usual care (- 9.55, 95% CI = - 14.66 to - 4.45).","['Osteoarthritis of the Knee', 'knee osteoarthritis', 'adults with knee osteoarthritis, with assessments at baseline and weeks 8, 16, 24, 36, and 52', 'Five hundred fifty-one screened for eligibility, 222 adults with knee osteoarthritis enrolled, 200 completed 8-week assessments, and 175 completed 52-week assessments']","['protocolized full-body massage or light-touch', 'whole-body massage', 'light-touch and usual care', 'Massage']","['Adverse events', 'WOMAC Global scores', 'pain, stiffness, and physical function WOMAC subscale scores', 'WOMAC Global', 'usual care', 'visual analog pain scale, PROMIS Pain Interference, knee range of motion, and timed 50-ft walk', 'Efficacy and Safety']","[{'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}]","[{'cui': 'C0556844', 'cui_str': 'Body massage (regime/therapy)'}, {'cui': 'C0423553', 'cui_str': 'Light touch, function (observable entity)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0042815', 'cui_str': 'Visual Analog Pain Scale'}, {'cui': 'C0576094', 'cui_str': 'Knee range of motion'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",222.0,0.0544883,"At 8 weeks, massage significantly improved WOMAC Global scores compared to light-touch (- 8.16, 95% CI = - 13.50 to - 2.81) and usual care (- 9.55, 95% CI = - 14.66 to - 4.45).","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Perlman', 'Affiliation': 'Duke Integrative Medicine, Durham, NC, USA. adam.perlman@duke.edu.'}, {'ForeName': 'Susan Gould', 'Initials': 'SG', 'LastName': 'Fogerite', 'Affiliation': 'Rutgers School of Health Professions, Institute for Complementary and Alternative Medicine, Newark, NJ, USA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Glass', 'Affiliation': 'Duke Integrative Medicine, Durham, NC, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bechard', 'Affiliation': 'Duke Integrative Medicine, Durham, NC, USA.'}, {'ForeName': 'Ather', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Valentine Y', 'Initials': 'VY', 'LastName': 'Njike', 'Affiliation': 'Yale-Griffin Prevention Research Center, Griffin Hospital, Yale University School of Public Health, Derby, CT, USA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Pieper', 'Affiliation': 'Duke Integrative Medicine, Durham, NC, USA.'}, {'ForeName': 'Natalia O', 'Initials': 'NO', 'LastName': 'Dmitrieva', 'Affiliation': 'Department of Psychological Sciences, Northern Arizona University, Flagstaff, AZ, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Luciano', 'Affiliation': 'Duke Integrative Medicine, Durham, NC, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Rosenberger', 'Affiliation': 'Yale-Griffin Prevention Research Center, Griffin Hospital, Yale University School of Public Health, Derby, CT, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Keever', 'Affiliation': 'Duke Integrative Medicine, Durham, NC, USA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Milak', 'Affiliation': 'Rutgers School of Health Professions, Institute for Complementary and Alternative Medicine, Newark, NJ, USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Gwendolyn', 'Initials': 'G', 'LastName': 'Mahon', 'Affiliation': 'Rutgers School of Health Professions, Institute for Complementary and Alternative Medicine, Newark, NJ, USA.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Campanile', 'Affiliation': 'Atlantic Integrative Medical Associates, Chambers Center for Well Being, Morristown, NJ, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Cotter', 'Affiliation': 'Veterans Administration New Jersey Health Care Center, East Orange, NJ, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Katz', 'Affiliation': 'Yale-Griffin Prevention Research Center, Griffin Hospital, Yale University School of Public Health, Derby, CT, USA.'}]",Journal of general internal medicine,['10.1007/s11606-018-4763-5']
154,32318781,Reducing recidivism using the Reasoning and Rehabilitation program: a pilot multi-site-controlled trial among prisoners in Switzerland.,"OBJECTIVES


This study evaluated whether the Reasoning and Rehabilitation (R&R2) program was effective in reducing recidivism, minimizing dropout rates, and improving outcomes related to attitudes, behaviors, and personality among people living in detention.
METHODS


Data were collected in eight Swiss German-speaking prisons among males detained for violent offenses using a quasi-experimental controlled design (R&R2: n = 129, treatment as usual [TAU]: n = 84). Measures included recidivism, dropout rate, and self-report questionnaires (hostile attribution bias, aggressiveness, interpersonal problems, and willingness to accept responsibility). Data were analyzed using mixed-effect models.
RESULTS


Participants in the R&R2 group were less likely to reoffend in comparison with the TAU group in the intention-to-treat (n = 51, odds ratio = 0.75, p = .060) and the per-protocol (excluding dropouts; n = 38, odds ratio = 0.65, p = .068) analyses. They also had lower self-reported scores of spontaneous and reactive aggressiveness (p = .047 and p = .070) and excitability (p = .086).
CONCLUSIONS


The findings of this pilot project were promising, with the R&R2 program leading to reduced recidivism and dropout rate. Even though these results should be considered preliminary, the R&R2 program appeared to be a relevant approach in reducing recidivism after prison.",2020,"RESULTS


Participants in the R&R2 group were less likely to reoffend in comparison with the TAU group in the intention-to-treat (n = 51, odds ratio = 0.75, p = .060) and the per-protocol (excluding dropouts; n = 38, odds ratio = 0.65, p = .068) analyses.","['people living in detention', 'prisoners in Switzerland', 'Data were collected in eight Swiss German-speaking prisons among males detained for violent offenses using a quasi-experimental controlled design (R&R2: n\u2009=\u2009129, treatment as usual [TAU]: n\u2009=\u200984']",['Reasoning and Rehabilitation (R&R2) program'],"['scores of spontaneous and reactive aggressiveness', 'recidivism, dropout rate, and self-report questionnaires (hostile attribution bias, aggressiveness, interpersonal problems, and willingness to accept responsibility', 'excitability']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0242151', 'cui_str': 'Violent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0680458', 'cui_str': 'Recidivism'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}]",8.0,0.0277735,"RESULTS


Participants in the R&R2 group were less likely to reoffend in comparison with the TAU group in the intention-to-treat (n = 51, odds ratio = 0.75, p = .060) and the per-protocol (excluding dropouts; n = 38, odds ratio = 0.65, p = .068) analyses.","[{'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Baggio', 'Affiliation': 'Department of Forensic Psychiatry, Institute of Forensic Medicine, University of Bern, Bern, Switzerland. stephanie.baggio@hcuge.ch.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weber', 'Affiliation': 'Office of Corrections, Canton of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Rossegger', 'Affiliation': 'Office of Corrections, Canton of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Endrass', 'Affiliation': 'Office of Corrections, Canton of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Heller', 'Affiliation': 'Division of Prison Health, Geneva University Hospitals and University of Geneva, Chemin du Petit Bel Air 2, 1226, Thônex, Geneva, Switzerland.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Schneeberger', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Graf', 'Affiliation': 'Forensic Psychiatric Hospital, Psychiatric Hospital of the University of Basel, Basel, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Liebrenz', 'Affiliation': 'Department of Forensic Psychiatry, Institute of Forensic Medicine, University of Bern, Bern, Switzerland.'}]",International journal of public health,['10.1007/s00038-020-01372-9']
155,32319681,Antidepressants for smoking cessation.,"BACKGROUND


Whilst the pharmacological profiles and mechanisms of antidepressants are varied, there are common reasons why they might help people to stop smoking tobacco. Firstly, nicotine withdrawal may produce depressive symptoms and antidepressants may relieve these. Additionally, some antidepressants may have a specific effect on neural pathways or receptors that underlie nicotine addiction.
OBJECTIVES


To assess the evidence for the efficacy, safety and tolerability of medications with antidepressant properties in assisting long-term tobacco smoking cessation in people who smoke cigarettes.
SEARCH METHODS


We searched the Cochrane Tobacco Addiction Specialized Register, which includes reports of trials indexed in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and PsycINFO, clinicaltrials.gov, the ICTRP, and other reviews and meeting abstracts, in May 2019.
SELECTION CRITERIA


We included randomized controlled trials (RCTs) that recruited smokers, and compared antidepressant medications with placebo or no treatment, an alternative pharmacotherapy, or the same medication used in a different way. We excluded trials with less than six months follow-up from efficacy analyses. We included trials with any follow-up length in safety analyses.
DATA COLLECTION AND ANALYSIS


We extracted data and assessed risk of bias using standard Cochrane methods. We also used GRADE to assess the certainty of the evidence. The primary outcome measure was smoking cessation after at least six months follow-up, expressed as a risk ratio (RR) and 95% confidence intervals (CIs). We used the most rigorous definition of abstinence available in each trial, and biochemically validated rates if available. Where appropriate, we performed meta-analysis using a fixed-effect model. Similarly, we presented incidence of safety and tolerance outcomes, including adverse events (AEs), serious adverse events (SAEs), psychiatric AEs, seizures, overdoses, suicide attempts, death by suicide, all-cause mortality, and trial dropout due to drug, as RRs (95% CIs).
MAIN RESULTS


We included 115 studies (33 new to this update) in this review; most recruited adult participants from the community or from smoking cessation clinics. We judged 28 of the studies to be at high risk of bias; however, restricting analyses only to studies at low or unclear risk did not change clinical interpretation of the results. There was high-certainty evidence that bupropion increased long-term smoking cessation rates (RR 1.64, 95% CI 1.52 to 1.77; I 2  = 15%; 45 studies, 17,866 participants). There was insufficient evidence to establish whether participants taking bupropion were more likely to report SAEs compared to those taking placebo. Results were imprecise and CIs encompassed no difference (RR 1.16, 95% CI 0.90 to 1.48; I 2  = 0%; 21 studies, 10,625 participants; moderate-certainty evidence, downgraded one level due to imprecision). We found high-certainty evidence that use of bupropion resulted in more trial dropouts due to adverse events of the drug than placebo (RR 1.37, 95% CI 1.21 to 1.56; I 2  = 19%; 25 studies, 12,340 participants). Participants randomized to bupropion were also more likely to report psychiatric AEs compared with those randomized to placebo (RR 1.25, 95% CI 1.15 to 1.37; I 2  = 15%; 6 studies, 4439 participants). We also looked at the safety and efficacy of bupropion when combined with other non-antidepressant smoking cessation therapies. There was insufficient evidence to establish whether combination bupropion and nicotine replacement therapy (NRT) resulted in superior quit rates to NRT alone (RR 1.19, 95% CI 0.94 to 1.51; I 2  = 52%; 12 studies, 3487 participants), or whether combination bupropion and varenicline resulted in superior quit rates to varenicline alone (RR 1.21, 95% CI 0.95 to 1.55; I 2  = 15%; 3 studies, 1057 participants). We judged the certainty of evidence to be low and moderate, respectively; in both cases due to imprecision, and also due to inconsistency in the former. Safety data were sparse for these comparisons, making it difficult to draw clear conclusions. A meta-analysis of six studies provided evidence that bupropion resulted in inferior smoking cessation rates to varenicline (RR 0.71, 95% CI 0.64 to 0.79; I 2  = 0%; 6 studies, 6286 participants), whilst there was no evidence of a difference in efficacy between bupropion and NRT (RR 0.99, 95% CI 0.91 to 1.09; I 2  = 18%; 10 studies, 8230 participants). We also found some evidence that nortriptyline aided smoking cessation when compared with placebo (RR 2.03, 95% CI 1.48 to 2.78; I 2  = 16%; 6 studies, 975 participants), whilst there was insufficient evidence to determine whether bupropion or nortriptyline were more effective when compared with one another (RR 1.30 (favouring bupropion), 95% CI 0.93 to 1.82; I 2  = 0%; 3 studies, 417 participants). There was no evidence that any of the other antidepressants tested (including St John's Wort, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs)) had a beneficial effect on smoking cessation. Findings were sparse and inconsistent as to whether antidepressants, primarily bupropion and nortriptyline, had a particular benefit for people with current or previous depression.
AUTHORS' CONCLUSIONS


There is high-certainty evidence that bupropion can aid long-term smoking cessation. However, bupropion also increases the number of adverse events, including psychiatric AEs, and there is high-certainty evidence that people taking bupropion are more likely to discontinue treatment compared with placebo. However, there is no clear evidence to suggest whether people taking bupropion experience more or fewer SAEs than those taking placebo (moderate certainty). Nortriptyline also appears to have a beneficial effect on smoking quit rates relative to placebo. Evidence suggests that bupropion may be as successful as NRT and nortriptyline in helping people to quit smoking, but that it is less effective than varenicline. There is insufficient evidence to determine whether the other antidepressants tested, such as SSRIs, aid smoking cessation, and when looking at safety and tolerance outcomes, in most cases, paucity of data made it difficult to draw conclusions. Due to the high-certainty evidence, further studies investigating the efficacy of bupropion versus placebo are unlikely to change our interpretation of the effect, providing no clear justification for pursuing bupropion for smoking cessation over front-line smoking cessation aids already available. However, it is important that where studies of antidepressants for smoking cessation are carried out they measure and report safety and tolerability clearly.",2020,"Findings were sparse and inconsistent as to whether antidepressants, primarily bupropion and nortriptyline, had a particular benefit for people with current or previous depression.
","['people who smoke cigarettes', '115 studies (33 new to this update) in this review; most recruited adult participants from the community or from smoking cessation clinics']","['bupropion', 'varenicline', 'nortriptyline', 'Nortriptyline', 'placebo', 'nicotine replacement therapy (NRT', 'placebo or no treatment, an alternative pharmacotherapy']","['adverse events', 'number of adverse events', 'nortriptyline aided smoking cessation', 'safety and efficacy', 'inferior smoking cessation rates', 'long-term smoking cessation rates', 'efficacy', 'efficacy, safety and tolerability', 'safety and tolerance outcomes, including adverse events (AEs), serious adverse events (SAEs), psychiatric AEs, seizures, overdoses, suicide attempts, death by suicide, all-cause mortality, and trial dropout due to drug, as RRs (95% CIs', 'superior quit rates', 'smoking cessation after at least six months follow-up, expressed as a risk ratio (RR) and 95% confidence intervals (CIs']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0028420', 'cui_str': 'Nortriptyline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0028420', 'cui_str': 'Nortriptyline'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",17866.0,0.519757,"Findings were sparse and inconsistent as to whether antidepressants, primarily bupropion and nortriptyline, had a particular benefit for people with current or previous depression.
","[{'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Howes', 'Affiliation': 'University of Oxford, Nuffield Department of Primary Care Health Sciences, Oxford, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Hartmann-Boyce', 'Affiliation': 'University of Oxford, Nuffield Department of Primary Care Health Sciences, Oxford, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Livingstone-Banks', 'Affiliation': 'University of Oxford, Nuffield Department of Primary Care Health Sciences, Oxford, UK.'}, {'ForeName': 'Bosun', 'Initials': 'B', 'LastName': 'Hong', 'Affiliation': 'Birmingham Dental Hospital, Oral Surgery Department, 5 Mill Pool Way, Birmingham, UK, B5 7EG.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lindson', 'Affiliation': 'University of Oxford, Nuffield Department of Primary Care Health Sciences, Oxford, UK.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD000031.pub5']
156,32319204,Successful introduction of milk after a negative double-blind placebo-controlled food challenge test is independent of the total dose and milk product used during the challenge test.,"BACKGROUND


Failure of milk introduction after a negative food challenge test is reported in a substantial number of patients. For this reason, guidelines recommend that the total dose of milk protein for a food challenge test should be comparable to a normal serving.
OBJECTIVE


Our aim is to compare the success rate of milk introduction after a negative double-blind placebo-controlled challenge test performed with different doses of milk protein and different milk products.
METHODS


We conducted a retrospective chart review of 485 patients challenged with a low or high dose of milk protein. Pasteurized milk and milk protein powder were used for the low-dose challenge tests, and condensed milk for the high-dose challenge tests. Successful introduction was defined as regular milk consumption, and discontinuation of further introduction due to the reappearance of symptoms as unsuccessful introduction. We also evaluated the association between milk products and successful introduction.
RESULTS


The outcome of 288 (59.4%) double-blind placebo-controlled food challenge tests was negative. There were no significant differences between the low and high dose of milk protein in patient characteristics, percentage of patients lost to follow-up (15% vs 20%), in whom introduction had not yet been performed (4% vs 3.1%), reappearance of symptoms (18% vs 17%), and successful introduction (88.0% and 83.4%). Age, gender, specific immunoglobulin E for milk, dose of milk protein, and atopy were not associated with successful introduction. Children who experienced symptoms during the introduction were less likely to consume milk (P < .001). There was a nonsignificant trend toward higher successful introduction rate if pasteurized milk was used as test material compared to milk protein powder, and condensed milk.
CONCLUSION AND CLINICAL RELEVANCE


Successful introduction of milk after a negative challenge test is independent of the total dose of milk protein, and milk product used during the challenge test.",2020,"There were no significant differences between the low and high dose of milk protein in patient characteristics, percentage of patients lost to follow-up (15% vs 20%), in whom introduction had not yet been performed (4% vs 3.1%), reappearance of symptoms (18% vs 17%), and successful introduction (88.0% and 83.4%).",['485 patients challenged with a low or high dose of milk protein'],"['milk protein and different milk products', 'Pasteurized milk and milk protein powder', 'placebo']","['successful introduction rate', 'reappearance of symptoms', 'successful introduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0026138', 'cui_str': 'Milk protein'}]","[{'cui': 'C0026138', 'cui_str': 'Milk protein'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",485.0,0.0428838,"There were no significant differences between the low and high dose of milk protein in patient characteristics, percentage of patients lost to follow-up (15% vs 20%), in whom introduction had not yet been performed (4% vs 3.1%), reappearance of symptoms (18% vs 17%), and successful introduction (88.0% and 83.4%).","[{'ForeName': 'Celine A', 'Initials': 'CA', 'LastName': 'van de Ven', 'Affiliation': 'Paediatric Allergy Centre, Department of Paediatrics, Martini Hospital, Groningen, The Netherlands.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Herpertz', 'Affiliation': 'Paediatric Allergy Centre, Department of Paediatrics, Martini Hospital, Groningen, The Netherlands.'}, {'ForeName': 'Lidy', 'Initials': 'L', 'LastName': 'van Lente', 'Affiliation': 'Department of Clinical Epidemiology, Martini Academy, Martini Hospital, Groningen, The Netherlands.'}, {'ForeName': 'Gerbrich N', 'Initials': 'GN', 'LastName': 'van der Meulen', 'Affiliation': 'Paediatric Allergy Centre, Department of Paediatrics, Martini Hospital, Groningen, The Netherlands.'}, {'ForeName': 'Arvid W A', 'Initials': 'AWA', 'LastName': 'Kamps', 'Affiliation': 'Paediatric Allergy Centre, Department of Paediatrics, Martini Hospital, Groningen, The Netherlands.'}]","Immunity, inflammation and disease",['10.1002/iid3.305']
157,32319313,Animal-Assisted Activity in Critically Ill Older Adults: A Randomized Pilot and Feasibility Trial.,"BACKGROUND


Limited evidence suggests the efficacy of animal-assisted activities (AAA) in improving biobehavioral stress responses in older patients in intensive care units (ICUs).
OBJECTIVES


To assess the feasibility of an AAA (dog) intervention for improving biobehavioral stress response, measured by self-reported stress and anxiety and salivary cortisol, C-reactive protein, and interleukin-1β in older ICU patients, we examined enrollment, attrition, completion, data collection, and biobehavioral stress responses.
METHODS


ICU patients ≥60 years old were randomly assigned to a 10-min AAA intervention or control/usual ICU care. Attitudes toward pets were assessed before the intervention. Self-reported stress and anxiety and salivary stress biomarkers were collected before and after the intervention and the usual care condition.
RESULTS


The majority of patients were ineligible due to lack of decisional capacity, younger age, inability to provide saliva specimens, or critical illness. Though 15 participants were randomly allocated (AAA = 9; control = 6), only 10 completed the study. All participants completed the questionnaires; however, saliva specimens were significantly limited by volume. AAA was associated with decreases in stress and anxiety. Biomarker results were variable and revealed no specific trends associated with stress responses.  Conclusions : Barriers to recruitment included an insufficient number of patients eligible for AAA based on hospital policy, difficulty finding patients who met study eligibility criteria, and illness-related factors. Recommendations for future studies include larger samples, a stronger control intervention such as a visitor without a dog, greater control over the AAA intervention, and use of blood from indwelling catheters for biomarkers.",2020,"METHODS


ICU patients ≥60 years old were randomly assigned to a 10-min AAA intervention or control/usual ICU care.","['older ICU patients', 'older patients in intensive care units (ICUs', 'Critically Ill Older Adults', '15 participants were randomly allocated (AAA = 9; control = 6), only 10 completed the study', 'ICU patients ≥60 years old']","['10-min AAA intervention or control/usual ICU care', 'AAA (dog) intervention', 'animal-assisted activities (AAA', 'AAA']","['biobehavioral stress responses', 'stress and anxiety', 'biobehavioral stress response, measured by self-reported stress and anxiety and salivary cortisol, C-reactive protein, and interleukin-1β', 'Self-reported stress and anxiety and salivary stress biomarkers']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",15.0,0.0547544,"METHODS


ICU patients ≥60 years old were randomly assigned to a 10-min AAA intervention or control/usual ICU care.","[{'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Branson', 'Affiliation': 'Cizik School of Nursing, The University of Texas Health Science Center at Houston, TX, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Boss', 'Affiliation': 'Cizik School of Nursing, The University of Texas Health Science Center at Houston, TX, USA.'}, {'ForeName': 'Shannan', 'Initials': 'S', 'LastName': 'Hamlin', 'Affiliation': 'Houston Methodist Hospital, TX, USA.'}, {'ForeName': 'Nikhil S', 'Initials': 'NS', 'LastName': 'Padhye', 'Affiliation': 'Cizik School of Nursing, The University of Texas Health Science Center at Houston, TX, USA.'}]",Biological research for nursing,['10.1177/1099800420920719']
158,32042166,An electroencephalographic signature predicts antidepressant response in major depression.,"Antidepressants are widely prescribed, but their efficacy relative to placebo is modest, in part because the clinical diagnosis of major depression encompasses biologically heterogeneous conditions. Here, we sought to identify a neurobiological signature of response to antidepressant treatment as compared to placebo. We designed a latent-space machine-learning algorithm tailored for resting-state electroencephalography (EEG) and applied it to data from the largest imaging-coupled, placebo-controlled antidepressant study (n = 309). Symptom improvement was robustly predicted in a manner both specific for the antidepressant sertraline (versus placebo) and generalizable across different study sites and EEG equipment. This sertraline-predictive EEG signature generalized to two depression samples, wherein it reflected general antidepressant medication responsivity and related differentially to a repetitive transcranial magnetic stimulation treatment outcome. Furthermore, we found that the sertraline resting-state EEG signature indexed prefrontal neural responsivity, as measured by concurrent transcranial magnetic stimulation and EEG. Our findings advance the neurobiological understanding of antidepressant treatment through an EEG-tailored computational model and provide a clinical avenue for personalized treatment of depression.",2020,Symptom improvement was robustly predicted in a manner both specific for the antidepressant sertraline (versus placebo) and generalizable across different study sites and EEG equipment.,['major depression'],"['placebo', 'latent-space machine-learning algorithm tailored for resting-state electroencephalography (EEG']","['sertraline resting-state EEG signature indexed prefrontal neural responsivity', 'Symptom improvement']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205275', 'cui_str': 'Latent (qualifier value)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0002045'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'EEG'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.035978,Symptom improvement was robustly predicted in a manner both specific for the antidepressant sertraline (versus placebo) and generalizable across different study sites and EEG equipment.,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'School of Automation Science and Engineering, South China University of Technology, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Molly V', 'Initials': 'MV', 'LastName': 'Lucas', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Fonzo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Camarin E', 'Initials': 'CE', 'LastName': 'Rolle', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Cherise', 'Initials': 'C', 'LastName': 'Chin-Fatt', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Noralie', 'Initials': 'N', 'LastName': 'Krepel', 'Affiliation': 'Research Institute Brainclinics, Brainclinics Foundation, Nijmegen, the Netherlands.'}, {'ForeName': 'Carena A', 'Initials': 'CA', 'LastName': 'Cornelssen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Wright', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Russell T', 'Initials': 'RT', 'LastName': 'Toll', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Hersh M', 'Initials': 'HM', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Monuszko', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Trevor L', 'Initials': 'TL', 'LastName': 'Caudle', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Kamron', 'Initials': 'K', 'LastName': 'Sarhadi', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Trombello', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Harvard Medical School and McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Adams', 'Affiliation': 'New York State Psychiatric Institute & Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McGrath', 'Affiliation': 'New York State Psychiatric Institute & Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Myrna M', 'Initials': 'MM', 'LastName': 'Weissman', 'Affiliation': 'New York State Psychiatric Institute & Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Harvard Medical School and McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'Department of Psychiatry, Harvard Medical School and McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Arns', 'Affiliation': 'Research Institute Brainclinics, Brainclinics Foundation, Nijmegen, the Netherlands.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Etkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA. amitetkin@stanford.edu.'}]",Nature biotechnology,['10.1038/s41587-019-0397-3']
159,32320131,International Consultation on Incontinence Questionnaire-Satisfaction: psychometric testing of a new patient-reported outcome measure for the evaluation of satisfaction after urological surgery.,"OBJECTIVES


To evaluate the psychometric properties of a new patient-reported outcome measure (PROM), the International Consultation on Incontinence Questionnaire-Satisfaction (ICIQ-S), to assess satisfaction after urological surgery.
SUBJECTS/PATIENTS AND METHODS


Following item development, the developmental ICIQ-S (dICIQ-S) was used within in a randomised control trial comparing two types of surgery for male prostatic obstruction at 1.5, 3, and 12 months after surgery. Reliability was assessed by Cronbach's α and construct validity by the correlation of scores with concurrently administered PROMs of known validity: ICIQ-Male Lower Urinary Tract Symptoms (LUTS), International Prostate Symptom Score, and the ICIQ-LUTS Quality of Life.
RESULTS


A total of 410 men were included in the trial. Missing data was generally low for the dICIQ-S [mean (range) 1.6 (<1-3.1)%] except for the items 'complications' 6.8% and 'satisfaction with sex-life' 9.2%. High ceiling effects were found in all items. Factor analysis identified six items related to surgical outcomes (Cronbach's α 0.89), which have formed the scored part of the ICIQ-S, together with a standalone overall satisfaction item, scored 0-10. Seven additional unscored items, related to satisfaction with experiences and expectations, were also retained. As hypothesised, post-surgery dICIQ-S scores were correlated with reduced symptoms and improved quality of life as measured by the concurrent PROMs.
CONCLUSION


The results support the validity and reliability of a scored six-item domain for evaluating satisfaction with surgical outcomes, together with a standalone scored overall satisfaction item. The further unscored seven standalone items are anticipated to be used as the basis for adaptation and further validation of the ICIQ-S in different patient populations.",2020,"As hypothesised, post-surgery dICIQ-S scores were correlated with reduced symptoms and improved quality of life as measured by the concurrent PROMs.
","['new patient', 'A total of 410 men were included in the trial']",[],['quality of life'],"[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",410.0,0.0449834,"As hypothesised, post-surgery dICIQ-S scores were correlated with reduced symptoms and improved quality of life as measured by the concurrent PROMs.
","[{'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': 'Uren', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Cotterill', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Hashim', 'Initials': 'H', 'LastName': 'Hashim', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Worthington', 'Affiliation': 'Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Dharmesh', 'Initials': 'D', 'LastName': 'Kapoor', 'Affiliation': 'Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Abrams', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, Bristol, UK.'}]",BJU international,['10.1111/bju.15091']
160,32314970,Sustainability of mHealth Effects on Cardiometabolic Risk Factors: Five-Year Results of a Randomized Clinical Trial.,"BACKGROUND


The long-term effects of mobile health (mHealth) interventions have not been documented, especially in resource-constrained settings.
OBJECTIVE


This study aimed to assess the effects of a 1-year mHealth intervention on blood pressure levels and body weight in low-resource urban settings in Peru, 4 years after the completion of the original study.
METHODS


Four years after the original Grupo de Investigación en Salud Móvil en America Latina (GISMAL) study, we attempted to contact the 212 individuals originally enrolled in the study in Peru. The primary outcomes were systolic and diastolic blood pressure levels and hypertension incidence. Secondary outcome measures were body weight, BMI, and self-reported target behaviors. The study personnel collecting the data were masked to the group assignment. Linear mixed models were used to evaluate the effects of the intervention on primary and secondary outcomes in an intention-to-treat analysis.
RESULTS


Data from 164 (77.4%) of the 212 originally enrolled participants were available and analyzed (80 in the intervention group and 84 in the control group). The intervention did not result in changes in systolic (-2.54 mm Hg, 95% CI -8.23 to 3.15) or diastolic (3.41 mm Hg, 95% CI -0.75 to 7.57) blood pressure compared with the control group. The intervention reduced the risk of developing hypertension, but the result was not significant (risk ratio (RR) 0.76, 95% CI 0.45-1.28). However, those who received the intervention had lower body weight (-5.42 kg, 95% CI -10.4 to -0.48) and BMI (-2.56 kg/m2, 95% CI -4.46 to -0.66). In addition, compared to the control participants, those who received ≥50% of the scheduled calls during the intervention had greater reductions in body weight (-6.23 kg, 95% CI -11.47 to -0.99) and BMI (-2.81 kg/m2, 95% CI -4.77 to -0.85).
CONCLUSIONS


An mHealth intervention comprising motivational interview calls and SMS text messaging appears to have effects on health 4 years after intervention completion. Although there were no effects on blood pressure levels, important reductions in body weight and BMI were seen 5 years after randomization. Thus, mHealth appears to be a promising preventive strategy for noncommunicable diseases in resource-constrained settings.
TRIAL REGISTRATION


Clinicaltrials.gov NCT01295216; https://clinicaltrials.gov/ct2/show/NCT01295216.",2020,An mHealth intervention comprising motivational interview calls and SMS text messaging appears to have effects on health 4 years after intervention completion.,"['212 individuals originally enrolled in the study in Peru', 'Data from 164 (77.4%) of the 212 originally enrolled participants were available and analyzed (80 in the intervention group and 84 in the control group', 'low-resource urban settings in Peru, 4 years after the completion of the original study']","['mobile health (mHealth) interventions', 'motivational interview calls and SMS text messaging', 'mHealth intervention']","['body weight', 'blood pressure', 'body weight, BMI, and self-reported target behaviors', 'changes in systolic', 'Cardiometabolic Risk Factors', 'BMI', 'risk of developing hypertension', 'body weight and BMI', 'diastolic', 'systolic and diastolic blood pressure levels and hypertension incidence', 'blood pressure levels and body weight', 'blood pressure levels', 'lower body weight']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205313', 'cui_str': 'Original'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C3178908', 'cui_str': 'Texting'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}]",212.0,0.145874,An mHealth intervention comprising motivational interview calls and SMS text messaging appears to have effects on health 4 years after intervention completion.,"[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bernabe-Ortiz', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Pauschardt', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Diez-Canseco', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'J Jaime', 'Initials': 'JJ', 'LastName': 'Miranda', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}]",Journal of medical Internet research,['10.2196/14595']
161,32314971,Evaluating an Intervention Program Using WeChat for Patients With Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial.,"BACKGROUND


The application of telemedicine in home pulmonary rehabilitation interventions for the management of patients with chronic obstructive pulmonary disease (COPD) has achieved promising results.
OBJECTIVE


This study aimed to develop a WeChat official account (Pulmonary Internet Explorer Rehabilitation [PeR]) based on social media. It further evaluated the effect of PeR on the quality of life, symptoms, and exercise self-efficacy of patients with COPD.
METHODS


The functional modules of PeR were developed by a multidisciplinary team according to the electronic health-enhanced chronic care model (eCCM) components. A total of 106 patients were randomly selected (53 in the PeR group and 53 in the outpatient face-to-face group [FtF]). Pulmonary rehabilitation intervention was conducted for 3 months, and the outcome was observed for 3 months. The primary outcome was patient quality of life measured with the COPD assessment test (CAT). The secondary outcomes were evaluated using the modified Medical Research Council scale (mMRC), exercise self-regulatory efficacy scale (Ex-SRES), and St George's Respiratory Questionnaire (SGRQ).
RESULTS


The intention-to-treat analysis was used in the study. A total of 94 participants completed the 6-month pulmonary rehabilitation program. No statistically significant differences were observed in CAT (F 1,3 =7.78, P=.001), Ex-SRES (F 1,3 =21.91, P<.001), and mMRC scores (F 1,3 =29.64, P<.001) between the two groups with the variation in time tendency. The Ex-SRES score had a significant effect on the CAT score (P=.03). The partial regression coefficient of Ex-SRES to CAT was 0.81, and Exp (B) was 2.24.
CONCLUSIONS


The telemedicine technology was effective using the eCCM combined with a behavioral intervention strategy centering on self-efficacy. Pulmonary rehabilitation at home through PeR and FtF could improve the sense of self-efficacy and quality of life and alleviate symptoms in patients with COPD.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR1900022770; https://tinyurl.com/tmmvpq3.",2020,"No statistically significant differences were observed in CAT (F 1,3 =7.78, P=.001), Ex-SRES (F 1,3 =21.91, P<.001), and mMRC scores (F 1,3 =29.64, P<.001) between the two groups with the variation in time tendency.","['patients with chronic obstructive pulmonary disease (COPD', '94 participants completed the 6-month pulmonary rehabilitation program', '106 patients were randomly selected (53 in the PeR group and 53 in the outpatient face-to-face group [FtF', 'Patients With Chronic Obstructive Pulmonary Disease', 'patients with COPD']","['telemedicine', 'Intervention Program Using WeChat', 'Pulmonary rehabilitation intervention', 'WeChat official account (Pulmonary Internet Explorer Rehabilitation [PeR']","['mMRC scores', ""modified Medical Research Council scale (mMRC), exercise self-regulatory efficacy scale (Ex-SRES), and St George's Respiratory Questionnaire (SGRQ"", 'sense of self-efficacy and quality of life and alleviate symptoms', 'CAT', 'CAT score', 'Ex-SRES', 'patient quality of life measured with the COPD assessment test (CAT', 'self-efficacy', 'quality of life, symptoms, and exercise self-efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",106.0,0.0856027,"No statistically significant differences were observed in CAT (F 1,3 =7.78, P=.001), Ex-SRES (F 1,3 =21.91, P<.001), and mMRC scores (F 1,3 =29.64, P<.001) between the two groups with the variation in time tendency.","[{'ForeName': 'Yuyu', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Research Office of Chronic Disease Management and Rehabilitation, Wuxi School of Medicine, Jiangnan University, Wuxi, China.'}, {'ForeName': 'Fenglan', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Research Office of Chronic Disease Management and Rehabilitation, Wuxi School of Medicine, Jiangnan University, Wuxi, China.'}, {'ForeName': 'Jianlan', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Research Office of Chronic Disease Management and Rehabilitation, Wuxi School of Medicine, Jiangnan University, Wuxi, China.'}, {'ForeName': 'Pingping', 'Initials': 'P', 'LastName': 'Sun', 'Affiliation': 'Research Office of Chronic Disease Management and Rehabilitation, Wuxi School of Medicine, Jiangnan University, Wuxi, China.'}, {'ForeName': 'Zhongyi', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Research Office of Chronic Disease Management and Rehabilitation, Wuxi School of Medicine, Jiangnan University, Wuxi, China.'}, {'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Wuxi School of Medicine, Jiangnan University, Wuxi, China.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Cai', 'Affiliation': 'Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': 'Hongqing', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': ""Wuxi Second People's Hospital, Wuxi, China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': 'Wuxi Second Hospital of Traditional Chinese Medicine, Wuxi, China.'}, {'ForeName': 'Zhaosheng', 'Initials': 'Z', 'LastName': 'Ding', 'Affiliation': 'Rongjun Hospital of Jiangsu Province, Wuxi, China.'}, {'ForeName': 'Xiaoliang', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Huishan District Rehabilitation Hospital, Wuxi, China.'}]",Journal of medical Internet research,['10.2196/17089']
162,32145522,"Haptic vs sensorimotor training in the treatment of upper limb dysfunction in multiple sclerosis: A multi-center, randomised controlled trial.","BACKGROUND


In multiple sclerosis (MS) exercise improves upper limb functions, but it is unclear what training types are more effective.
OBJECTIVE


This study compares robot-assisted training based on haptic or sensorimotor exercise.
METHODS


41clinically definite MS subjects with upper limb impairment were randomised into two groups: (i) Haptic and (ii) Sensorimotor. Subjects in the Haptic performed a robot-assisted training protocol designed to counteract incoordination and weakness. The task -interaction with a virtual mass-spring system against a resistive load- requires coordination skills. Task difficulty and magnitude of resistive load were automatically adjusted to the individual impairment. Subjects in the Sensorimotor performed reaching movements under visual control; the robot generated no forces. Both groups underwent eight training sessions (40 min/session, 2 sessions/week). Treatment outcome were 9HPT and ARAT scores.
RESULTS


The average 9HPT score decreased from 74±9 s to 61±8 s for the Haptic and from 49±6 s to 44±6 s. We found a significant Treatment (p=.0453) and Time differences (p=.005), but no significant Treatment×Time interactions although we found that the absolute change was only significant in the Haptic group (p=.011). We observed no significant changes in the ARAT score. Participants tolerated treatments well with a low drop-out rate. In the subjects evaluated at after 12 week (11 subject in sensory-motor and 17 in haptic group) no retention of the effect was found.
CONCLUSIONS


Task oriented training may improve upper limb function in persons with MS especially in prevalent pyramidal impaired subjects without maintain the effects after three months.
CLINICAL TRIAL REGISTRATION NUMBER


NCT02711566 (clinicaltrial.gov).",2020,The average 9HPT score decreased from 74±9 s to 61±8 s for the Haptic and from 49±6 s to 44±6 ,"['41clinically definite MS subjects with upper limb impairment', 'multiple sclerosis']","['Haptic vs sensorimotor training', 'Haptic and (ii) Sensorimotor', 'Task oriented training', 'robot-assisted training based on haptic or sensorimotor exercise']","['ARAT score', 'average 9HPT score', 'Task difficulty and magnitude of resistive load', 'upper limb function', '9HPT and ARAT scores']","[{'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C1264673', 'cui_str': 'Arbitrary rate'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0138922,The average 9HPT score decreased from 74±9 s to 61±8 s for the Haptic and from 49±6 s to 44±6 ,"[{'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Solaro', 'Affiliation': 'Department of Rehabilitation, Mons L Novarese Hospital, Moncrivello, Italy; Department of Head and Neck, ASL 3 Genovese, Genoa, Italy. Electronic address: csolaro@libero.it.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Cattaneo', 'Affiliation': 'Department of Neurorehabilitation, Don Gnocchi Foundation IRCCS, Milan, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Basteris', 'Affiliation': 'Department of Informatics, Bioengineering, Robotics and Systems Engineering, University of Genoa, Genoa, Italy; Recover Injury Research Centre, Griffith University, Gold Coast, Australia.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Carpinella', 'Affiliation': 'Department of Biomedical Technology, Don Gnocchi Foundation IRCCS, Milan, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'De Luca', 'Affiliation': 'Department of Informatics, Bioengineering, Robotics and Systems Engineering, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Margit', 'Initials': 'M', 'LastName': 'Mueller', 'Affiliation': 'Department of Head and Neck, ASL 3 Genovese, Genoa, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Bertoni', 'Affiliation': 'Department of Neurorehabilitation, Don Gnocchi Foundation IRCCS, Milan, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Ferrarin', 'Affiliation': 'Department of Biomedical Technology, Don Gnocchi Foundation IRCCS, Milan, Italy.'}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Sanguineti', 'Affiliation': 'Department of Informatics, Bioengineering, Robotics and Systems Engineering, University of Genoa, Genoa, Italy.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116743']
163,32316801,"A prospective, crossover randomized trial of the optimal timing for leucovorin rescue after high-dose methotrexate management in adult non-Hodgkin's lymphoma patients.","This study aimed to investigate the optimal time of leucovorin rescue for HDMTX in non-Hodgkin's lymphoma (NHL) patients. Ninety-eight patients treated with HDMTX were randomly assigned to receive leucovorin at either 18 or 24 h after initiation of HDMTX infusion during the first cycle and switched to the other mode in the second cycle. All courses achieved an efficacious MTX concentration. Compared to the 18th hour group, the 24th hour group exhibited an increase in incidence of thrombocytopenia (48% versus 34.7%,  p  = .036) and grade III/IV neutropenia (34.7% versus 21.4%,  p  = .039). No bleeding occurred and the incidence of fever with grade III/IV neutropenia was low with no difference observed between the two groups. We recommend that with the HDMTX generally used most adult patients with NHL may have greater therapeutic benefit and acceptable toxicity with their LV rescue started at 24 h instead of 18 h.",2020,No bleeding occurred and the incidence of fever with grade III/IV neutropenia was low with no difference observed between the two groups.,"['Ninety-eight patients treated with', ""non-Hodgkin's lymphoma (NHL) patients"", 'adult patients with NHL', ""adult non-Hodgkin's lymphoma patients""]","['HDMTX', 'leucovorin', 'HDMTX infusion', 'leucovorin rescue after high-dose methotrexate management', 'leucovorin rescue for HDMTX']","['grade III/IV neutropenia', 'incidence of thrombocytopenia', 'therapeutic benefit and acceptable toxicity', 'incidence of fever with grade III/IV neutropenia', 'bleeding', 'efficacious MTX concentration']","[{'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0024305', 'cui_str': 'Malignant lymphoma, non-Hodgkin'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0244194,No bleeding occurred and the incidence of fever with grade III/IV neutropenia was low with no difference observed between the two groups.,"[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Peng', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Xueying', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Tingzhi', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Xiaojie', 'Initials': 'X', 'LastName': 'Fang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Huangming', 'Initials': 'H', 'LastName': 'Hong', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Fangfang', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Quanguang', 'Initials': 'Q', 'LastName': 'Ren', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Tongyu', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}]",Leukemia & lymphoma,['10.1080/10428194.2020.1747061']
164,31406230,Fecal microbiome and metabolome of infants fed bovine MFGM supplemented formula or standard formula with breast-fed infants as reference: a randomized controlled trial.,"Human milk delivers an array of bioactive components that safeguard infant growth and development and maintain healthy gut microbiota. Milk fat globule membrane (MFGM) is a biologically functional fraction of milk increasingly linked to beneficial outcomes in infants through protection from pathogens, modulation of the immune system and improved neurodevelopment. In the present study, we characterized the fecal microbiome and metabolome of infants fed a bovine MFGM supplemented experimental formula (EF) and compared to infants fed standard formula (SF) and a breast-fed reference group. The impact of MFGM on the fecal microbiome was moderate; however, the fecal metabolome of EF-fed infants showed a significant reduction of several metabolites including lactate, succinate, amino acids and their derivatives from that of infants fed SF. Introduction of weaning food with either human milk or infant formula reduces the distinct characteristics of breast-fed- or formula-fed- like infant fecal microbiome and metabolome profiles. Our findings support the hypothesis that higher levels of protein in infant formula and the lack of human milk oligosaccharides promote a shift toward amino acid fermentation in the gut. MFGM may play a role in shaping gut microbial activity and function.",2019,"Milk fat globule membrane (MFGM) is a biologically functional fraction of milk increasingly linked to beneficial outcomes in infants through protection from pathogens, modulation of the immune system and improved neurodevelopment.",[],"['Milk fat globule membrane (MFGM', 'weaning food with either human milk or infant formula', 'bovine MFGM supplemented experimental formula (EF) and compared to infants fed standard formula (SF) and a breast-fed reference group', 'MFGM', 'bovine MFGM supplemented formula or standard formula with breast-fed infants']","['several metabolites including lactate, succinate, amino acids and their derivatives']",[],"[{'cui': 'C0670751', 'cui_str': 'milk fat globule'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0453868', 'cui_str': 'Weaning food (substance)'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0150589', 'cui_str': 'Baby Formula'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C3853255', 'cui_str': 'Standard formula'}, {'cui': 'C0006147', 'cui_str': 'Breastfeeding'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}]","[{'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0038617', 'cui_str': 'Succinates'}, {'cui': 'C3653632', 'cui_str': 'Amino acids and derivatives'}]",,0.0355952,"Milk fat globule membrane (MFGM) is a biologically functional fraction of milk increasingly linked to beneficial outcomes in infants through protection from pathogens, modulation of the immune system and improved neurodevelopment.","[{'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Nutrition, University of California Davis, One Shields Ave, Davis, CA, 95616, USA.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Parenti', 'Affiliation': 'Department of Nutrition, University of California Davis, One Shields Ave, Davis, CA, 95616, USA.'}, {'ForeName': 'Tove', 'Initials': 'T', 'LastName': 'Grip', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Umeå University, SE901 85, Umeå, Sweden.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Lönnerdal', 'Affiliation': 'Department of Nutrition, University of California Davis, One Shields Ave, Davis, CA, 95616, USA.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Timby', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Umeå University, SE901 85, Umeå, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Domellöf', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Umeå University, SE901 85, Umeå, Sweden.'}, {'ForeName': 'Olle', 'Initials': 'O', 'LastName': 'Hernell', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Umeå University, SE901 85, Umeå, Sweden.'}, {'ForeName': 'Carolyn M', 'Initials': 'CM', 'LastName': 'Slupsky', 'Affiliation': 'Department of Nutrition, University of California Davis, One Shields Ave, Davis, CA, 95616, USA. cslupsky@ucdavis.edu.'}]",Scientific reports,['10.1038/s41598-019-47953-4']
165,32315461,Impact of STEADI-Rx: A Community Pharmacy-Based Fall Prevention Intervention.,"OBJECTIVES


To evaluate the effects of a community pharmacy-based fall prevention intervention (STEADI-Rx) on the risk of falling and use of medications associated with an increased risk of falling.
DESIGN


Randomized controlled trial.
SETTING


A total of 65 community pharmacies in North Carolina (NC).
PARTICIPANTS


Adults (age ≥65 years) using either four or more chronic medications or one or more medications associated with an increased risk of falling (n = 10,565).
INTERVENTION


Pharmacy staff screened patients for fall risk using questions from the Stopping Elderly Accidents, Deaths, and Injuries (STEADI) algorithm. Patients who screened positive were eligible to receive a pharmacist-conducted medication review, with recommendations sent to patients' healthcare providers following the review.
MEASUREMENTS


At intervention pharmacies, pharmacy staff used standardized forms to record participant responses to screening questions and information concerning the medication reviews. For participants with continuous Medicare Part D/NC Medicaid coverage (n = 3,212), the Drug Burden Index (DBI) was used to assess exposure to high-risk medications, and insurance claims records for emergency department visits and hospitalizations were used to assess falls.
RESULTS


Among intervention group participants (n = 4,719), 73% (n = 3,437) were screened for fall risk. Among those who screened positive (n = 1,901), 72% (n = 1,373) received a medication review; and 27% (n = 521) had at least one medication-related recommendation communicated to their healthcare provider(s) following the review. A total of 716 specific medication recommendations were made. DBI scores decreased from the pre- to postintervention period in both the control and the intervention group. However, the amount of change over time did not differ between these two groups (P = .66). Risk of falling did not change between the pre- to postintervention period or differ between groups (P = .58).
CONCLUSION


We successfully implemented STEADI-Rx in the community pharmacy setting. However, we found no differences in fall risk or the use of medications associated with increased risk of falling between the intervention and control groups. J Am Geriatr Soc 68:1778-1786, 2020.",2020,"Risk of falling did not change between the pre- to postintervention period or differ between groups (P = .58).
","['A total of 65 community pharmacies in North Carolina (NC', 'participants with continuous Medicare Part D/NC Medicaid coverage (n = 3,212), the Drug Burden Index (DBI) was used to assess exposure to high-risk medications, and insurance claims records for emergency department visits and hospitalizations were used to assess falls', 'Adults (age ≥65\u2009years) using either four or more chronic medications or one or more medications associated with an increased risk of falling (n = 10,565', 'Among those who screened positive (n = 1,901), 72% (n = 1,373) received a medication review; and 27% (n = 521) had at least one medication-related recommendation communicated to their healthcare provider(s) following the review', ""Patients who screened positive were eligible to receive a pharmacist-conducted medication review, with recommendations sent to patients' healthcare providers following the review""]",['community pharmacy-based fall prevention intervention (STEADI-Rx'],"['DBI scores', 'fall risk', 'Risk of falling', 'risk of falling']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1955953', 'cui_str': 'Medicare Part D'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205196', 'cui_str': 'Communicating'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0000924', 'cui_str': 'Accident'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",3437.0,0.0297205,"Risk of falling did not change between the pre- to postintervention period or differ between groups (P = .58).
","[{'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Blalock', 'Affiliation': 'Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Stefanie P', 'Initials': 'SP', 'LastName': 'Ferreri', 'Affiliation': 'Division of Practice Advancement and Clinical Education, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Chelsea P', 'Initials': 'CP', 'LastName': 'Renfro', 'Affiliation': 'Department of Clinical Pharmacy and Translational Science, University of Tennessee Health Science Center College of Pharmacy, Memphis, Tennessee, USA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Robinson', 'Affiliation': 'Division of Practice Advancement and Clinical Education, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Joel F', 'Initials': 'JF', 'LastName': 'Farley', 'Affiliation': 'Department of Pharmaceutical Care & Health Systems, University of Minnesota College of Pharmacy, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Neepa', 'Initials': 'N', 'LastName': 'Ray', 'Affiliation': 'University of North Carolina, Eshelman School of Pharmacy, Center for Medication Optimization Through Practice and Policy, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Busby-Whitehead', 'Affiliation': 'Division of Geriatric Medicine and Center of Aging and Health, UNC School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16459']
166,32316014,Controlling Blood Pressure Under Transcranial Doppler Guidance after Endovascular Treatment in Patients with Acute Ischemic Stroke.,"OBJECTIVE


This study aimed to control blood pressure (BP) under transcranial Doppler (TCD) guidance in patients with anterior circulation acute ischemic stroke after endovascular treatment (EVT) to reduce the incidence of early neurological deterioration (END) and improve neurological prognosis.
METHODS


This prospective randomized controlled study included 95 patients who were randomly divided into a TCD-guided BP control (TBC) group and a non-TCD-guided BP control (NBC) group. The patients were monitored by TCD within 72 h after EVT. In the TBC group, BP decreased, BP increased, or intracranial pressure decreased when TCD showed blood flow acceleration, deceleration, or intracranial hypertension respectively. The BP of the NBC group was controlled according to the guidelines. The incidence of END and the prognosis was compared between the 2 groups.
RESULTS


TCD identified 18 patients with blood flow acceleration, but the prognosis of the 2 groups was not significantly different. TCD identified 23 patients with blood flow deceleration, and the poor prognosis rate at discharge was lower in the TBC group than in the NBC group (45.5 vs. 91.7%, p = 0.027). TCD identified 34 patients with intracranial hypertension, and the 3-month mortality rate of the TBC group was lower than that of the NBC group (0 vs. 36.8%, p = 0.011). The incidence rates of END and 3-month mortality in the TBC group were lower than those in the NBC group (13.8 vs. 37.5%, p = 0.036; 0 vs. 25.0%, p = 0.012) when TCD parameters were abnormal. Multivariable logistic regression analysis showed that the TBC group (adjusted OR 0.267, 95% CI 0.074-0.955; p = 0.042) was an independent protective factor against the incidence of END when TCD parameters were abnormal.
CONCLUSION


These findings indicated that TCD-guided BP and intracranial pressure control improved the prognosis of patients with blood flow deceleration and intracranial hypertension.",2020,"The incidence rates of END and 3-month mortality in the TBC group were lower than those in the NBC group (13.8 vs. 37.5%, p = 0.036; 0 vs. 25.0%, p = 0.012) when TCD parameters were abnormal.","['34 patients with intracranial hypertension', '95 patients who were randomly divided into a', 'patients with anterior circulation acute ischemic stroke after endovascular treatment (EVT', 'Patients with Acute Ischemic Stroke']","['control blood pressure (BP) under transcranial Doppler (TCD) guidance', 'NBC', 'TCD', 'TCD-guided BP and intracranial pressure control', 'TCD-guided BP control (TBC) group and a non-TCD-guided BP control (NBC']","['3-month mortality rate', 'BP increased, or intracranial pressure', 'blood flow deceleration', 'poor prognosis rate at discharge', 'incidence rates of END and 3-month mortality', 'blood flow acceleration, deceleration, or intracranial hypertension', 'blood flow acceleration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0151740', 'cui_str': 'Raised intracranial pressure'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0206077', 'cui_str': 'Transcranial doppler ultrasonography'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0007928', 'cui_str': 'Chad'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0497247', 'cui_str': 'Elevated blood pressure'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0011100', 'cui_str': 'Deceleration'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0151740', 'cui_str': 'Raised intracranial pressure'}]",95.0,0.0190262,"The incidence rates of END and 3-month mortality in the TBC group were lower than those in the NBC group (13.8 vs. 37.5%, p = 0.036; 0 vs. 25.0%, p = 0.012) when TCD parameters were abnormal.","[{'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China, suyingying@xwh.ccmu.edu.cn.'}, {'ForeName': 'Yanbo', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yingbo', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yijia', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhongyun', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}]","Cerebrovascular diseases (Basel, Switzerland)",['10.1159/000506855']
167,32144874,The influence of HIV-related stigma on PrEP disclosure and adherence among adolescent girls and young women in HPTN 082: a qualitative study.,"INTRODUCTION


Stigma and disclosure concerns have been key barriers to oral pre-exposure prophylaxis (PrEP) adherence for African adolescent girls and young women (AGYW) in efficacy trials. We aimed to understand the impact of these factors among African AGYW in an open-label PrEP study.
METHODS


HPTN 082 was an open-label PrEP study among AGYW (ages 16 to 24) in Harare, Zimbabwe, and Cape Town and Johannesburg, South Africa from 2016 to 2018. Women starting PrEP were randomized to standard adherence support (counselling, two-way SMS, monthly adherence clubs) or standard support plus drug-level feedback. Serial in-depth interviews were conducted among 67 AGYW after 13-week and 26-week study visits to explore experiences of stigma, disclosure and PrEP adherence. We analysed data by coding transcripts and memo-writing and diagramming to summarize themes.
RESULTS


AGYW described stigma related to sexual activity (e.g. ""people say I'm a prostitute"") and being perceived to be living with HIV because of taking antiretrovirals (e.g. ""my husband's friends say I'm HIV infected""). Participants who anticipated stigma were reluctant to disclose PrEP use and reported adherence challenges. Disclosure also resulted in stigmatizing experiences. Across all sites, negative descriptions of stigma and disclosure challenges were more common in the first interview. In the second interview, participants often described disclosure as an ""empowering"" way to combat community-level PrEP stigma; many said that they proactively discussed PrEP in their communities (e.g. became a ""community PrEP ambassador""), which improved their ability to take PrEP and encourage others to use PrEP. These empowering disclosure experiences were facilitated by ongoing HPTN 082 study activities (e.g. counselling sessions, adherence clubs) in which they could discuss PrEP-related stigma, disclosure and PrEP adherence issues.
CONCLUSIONS


Stigma and disclosure challenges were initial concerns for African AGYW newly initiating PrEP but many were empowered to disclose PrEP use over their first six months of PrEP use, which helped them cope with stigma and feel more able to take PrEP regularly. PrEP programmes can foster disclosure through community and clinic-based discussion, adherence clubs and activities normalizing sexual behaviour and PrEP use, which can reduce stigma and improve PrEP adherence and thus effectiveness.",2020,"INTRODUCTION


Stigma and disclosure concerns have been key barriers to oral pre-exposure prophylaxis (PrEP) adherence for African adolescent girls and young women (AGYW) in efficacy trials.","['adolescent girls and young women in HPTN 082', 'HPTN 082 was an open-label PrEP study among AGYW (ages 16 to 24) in Harare, Zimbabwe, and Cape Town and Johannesburg, South Africa from 2016 to 2018', 'Women starting PrEP', 'African adolescent girls and young women']","['oral pre-exposure prophylaxis (PrEP) adherence', 'standard adherence support (counselling, two-way SMS, monthly adherence clubs) or standard support plus drug-level feedback', 'HIV-related stigma']","['stigma, disclosure and PrEP adherence']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C1272689', 'cui_str': 'Started'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0428212', 'cui_str': 'Finding of drug level (finding)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}]",,0.0345496,"INTRODUCTION


Stigma and disclosure concerns have been key barriers to oral pre-exposure prophylaxis (PrEP) adherence for African adolescent girls and young women (AGYW) in efficacy trials.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Velloza', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Nomhle', 'Initials': 'N', 'LastName': 'Khoza', 'Affiliation': 'Wits Reproductive Health & HIV Institute (Wits RHI), Johannesburg, South Africa.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Scorgie', 'Affiliation': 'Wits Reproductive Health & HIV Institute (Wits RHI), Johannesburg, South Africa.'}, {'ForeName': 'Miria', 'Initials': 'M', 'LastName': 'Chitukuta', 'Affiliation': 'Clinical Trials Research Centre, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Prisca', 'Initials': 'P', 'LastName': 'Mutero', 'Affiliation': 'Clinical Trials Research Centre, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Kudzai', 'Initials': 'K', 'LastName': 'Mutiti', 'Affiliation': 'Clinical Trials Research Centre, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Nomvuyo', 'Initials': 'N', 'LastName': 'Mangxilana', 'Affiliation': 'Desmond Tutu HIV Foundation, Cape Town, South Africa.'}, {'ForeName': 'Lumka', 'Initials': 'L', 'LastName': 'Nobula', 'Affiliation': 'Desmond Tutu HIV Foundation, Cape Town, South Africa.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Bulterys', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Millicent', 'Initials': 'M', 'LastName': 'Atujuna', 'Affiliation': 'Desmond Tutu HIV Foundation, Cape Town, South Africa.'}, {'ForeName': 'Sybil', 'Initials': 'S', 'LastName': 'Hosek', 'Affiliation': 'Stroger H. Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Heffron', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'Faculty of Health Sciences, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Nyaradzo', 'Initials': 'N', 'LastName': 'Mgodi', 'Affiliation': 'Clinical Trials Research Centre, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Chirenje', 'Affiliation': 'Clinical Trials Research Centre, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Celum', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Sinead', 'Initials': 'S', 'LastName': 'Delany-Moretlwe', 'Affiliation': 'Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the International AIDS Society,['10.1002/jia2.25463']
168,32311845,Changes in respiratory mechanics at birth in preterm infants: A pilot study.,"OBJECTIVE


We aimed to measure lung mechanics at birth by the forced oscillation technique (FOT) for assessment of the initial degree of lung aeration and the short-term aeration changes after applying different respiratory support strategies.
METHODS


Eighteen preterm infants (gestational age = 29-36 week) were randomized to receive either continuous positive airway pressure (CPAP) at 5 cmH 2  O only or combined with a sustained inflation (SI; 15 seconds at 25 cmH 2  O after 5 seconds of CPAP) at birth. We assessed the respiratory system reactance at 5 Hz (X 5;  increases with lung volume recruitment at a given distending pressure) at 2, 40, and 150 seconds after initiation of CPAP. k-Means clustering of the initial X 5  value (X 5,i  ) stratified newborn into either infants with lower (lowerX 5,i  ; X 5   < -280 cmH 2  O*s/L) and higher (higherX 5,i  ; X 5   > -240 cmH 2  O*s/L) initial degree of lung volume recruitment.
RESULTS


Initial values were highly heterogeneous. In the LowerX 5,i  group, X 5  increased with time, with SI-patients showing significantly higher values at 150 seconds than the non-SI group (X 5   = -89 ± 27 cmH 2  O vs -274 ± 58 cmH 2  O). In the higherX 5,i  group, X 5  did not improve with time, regardless of the respiratory strategy, suggesting a lack of lung recruitment. Moreover, 75% of infants receiving SI in the higherX 5,i  group experienced a transient loss of aeration after the maneuver.
CONCLUSIONS


Preterm newborns present initially with highly heterogeneous lung aeration at birth that significantly impacts the effectiveness of the subsequent lung volume recruitment strategy. FOT may represent a valuable tool for individualizing a respiratory resuscitation at birth as it is noninvasive and may be applied simultaneously to respiratory support.",2020,"In the higherX 5,i  group, X 5  did not improve with time, regardless of the respiratory strategy, suggesting a lack of lung recruitment.","['Eighteen preterm infants (gestational age\u2009=\u200929-36 week', 'preterm infants']","['continuous positive airway pressure (CPAP) at 5\u2009cmH 2  O only or combined with a sustained inflation (SI; 15\u2009seconds at 25\u2009cmH 2  O after 5\u2009seconds of CPAP', 'FOT', 'forced oscillation technique (FOT']","['respiratory system reactance', 'transient loss of aeration']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0035237', 'cui_str': 'Structure of respiratory system'}, {'cui': 'C0040704', 'cui_str': 'Transients'}]",18.0,0.0588961,"In the higherX 5,i  group, X 5  did not improve with time, regardless of the respiratory strategy, suggesting a lack of lung recruitment.","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Veneroni', 'Affiliation': 'TechRes lab, Department of Electronics, Information and bioengineering, Politecnico di Milano University, Milano, Italy.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Mercadante', 'Affiliation': ""Neonatal Intensive Care Unit (NICU), Fondazione IRCCS Ca'Granda Foundation, Ospedale Maggiore Policlinico Hospital-Università degli Studi di Milano, Milan, Italy.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lavizzari', 'Affiliation': ""Neonatal Intensive Care Unit (NICU), Fondazione IRCCS Ca'Granda Foundation, Ospedale Maggiore Policlinico Hospital-Università degli Studi di Milano, Milan, Italy.""}, {'ForeName': 'Mariarosa', 'Initials': 'M', 'LastName': 'Colnaghi', 'Affiliation': ""Neonatal Intensive Care Unit (NICU), Fondazione IRCCS Ca'Granda Foundation, Ospedale Maggiore Policlinico Hospital-Università degli Studi di Milano, Milan, Italy.""}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Mosca', 'Affiliation': ""Neonatal Intensive Care Unit (NICU), Fondazione IRCCS Ca'Granda Foundation, Ospedale Maggiore Policlinico Hospital-Università degli Studi di Milano, Milan, Italy.""}, {'ForeName': 'Raffaele L', 'Initials': 'RL', 'LastName': 'Dellacà', 'Affiliation': 'TechRes lab, Department of Electronics, Information and bioengineering, Politecnico di Milano University, Milano, Italy.'}]",Pediatric pulmonology,['10.1002/ppul.24772']
169,32311349,Pneumonia and Exposure to Household Air Pollution in Children Under the Age of 5 Years in Rural Malawi: Findings From the Cooking and Pneumonia Study.,"BACKGROUND


Exposure to household air pollution is associated with an increased risk of pneumonia in children in low- and middle-income countries; however, exposure-response data are limited, and there are uncertainties around the extent to which biomass-fueled cookstoves can reduce these exposures.
RESEARCH QUESTION


What is the association between exposure to household air pollution and pneumonia in children under the age of 5 years in rural Malawi and what are the effects of a biomass-fueled cookstove intervention on personal exposure to household air pollution?
STUDY DESIGN AND METHODS


We measured personal exposure to carbon monoxide (CO; 48 hours of continuous measurement and transcutaneous carboxyhemoglobin) every 6 months in children who participated in a cluster-randomized controlled trial of a cleaner burning biomass-fueled cookstove intervention to prevent pneumonia in children under the age of 5 years in rural Malawi (the Cooking And Pneumonia Study). Exposure-response and multivariable analyses were done.
RESULTS


We recruited 1805 (928 intervention; 877 control) children (mean age, 25.6 months; 50.6% female). We found no evidence of an association between exposure to CO (incident rate ratio, 1.0; 95% CI, 0.967 to 1.014; P = .53) or carboxyhemoglobin (incident rate ratio, 1.00; 95% CI, 0.993 to 1.003; P = .41) in children who experienced pneumonia vs those who did not. Median exposure to CO in the intervention and control groups was was 0.34 (interquartile range, 0.15 to 0.81) and 0.37 parts per million (interquartile range, 0.15 toa 0.97), respectively. The group difference in means was 0.46 (95% CI, -0.95 to 0.012; P = .06).
INTERPRETATION


Exposure to CO in our population was low with no association seen between exposure to CO and pneumonia incidence and no effect of the Cooking And Pneumonia Study intervention on these exposures. These findings suggest that CO may not be an appropriate measure of household air pollution exposure in settings such as rural Malawi and that there is a need to develop ways to measure particulate matter exposures directly in young children instead.
CLINICAL TRIAL REGISTRATION


ISRCTN59448623.",2020,"The group difference in means was 0.46 (95% CI:-0.95-0.012; p=0.06).
","['children under the age of 5 years in rural Malawi', 'children under the age of 5 years in rural Malawi - the Cooking And Pneumonia Study (CAPS', 'children participating in a cluster-randomised controlled trial of a', 'young children instead', 'We recruited 1805 (928 intervention; 877 control) children (mean age 25.6 months, 50.6% female', 'children under the age of 5 in rural Malawi']","['COHb ', 'CAPS intervention', 'personal exposure to carbon monoxide (CO', 'transcutaneous carboxyhemoglobin (COHb', 'cleaner-burning biomass-fueled cookstove intervention']",['Median exposure to CO'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0007061', 'cui_str': 'Carboxyhemoglobin'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0238889', 'cui_str': 'Exposure to carbon monoxide'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0238889', 'cui_str': 'Exposure to carbon monoxide'}]",,0.0927706,"The group difference in means was 0.46 (95% CI:-0.95-0.012; p=0.06).
","[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Mortimer', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK. Electronic address: Kevin.mortimer@lstmed.ac.uk.'}, {'ForeName': 'Maia', 'Initials': 'M', 'LastName': 'Lesosky', 'Affiliation': 'University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Semple', 'Affiliation': 'Stirling University, Stirling, UK.'}, {'ForeName': 'Jullita', 'Initials': 'J', 'LastName': 'Malava', 'Affiliation': 'Malawi Epidemiology and Intervention Research Unit, Chilumba, Malawi.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Katundu', 'Affiliation': 'Malawi Epidemiology and Intervention Research Unit, Chilumba, Malawi.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Crampin', 'Affiliation': 'Malawi Epidemiology and Intervention Research Unit, Chilumba, Malawi; London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Weston', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Pope', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Havens', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Gordon', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK; Malawi Liverpool Wellcome Trust Programme, Blantyre, Malawi.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Balmes', 'Affiliation': 'University of California, Berkeley, CA; University of California, San Francisco, San Francisco, CA.'}]",Chest,['10.1016/j.chest.2020.03.064']
170,32081767,"Calories, Caffeine and the Onset of Obesity in Young Children.","OBJECTIVE


High calorie foods and beverages, which often contain caffeine, contribute to child overweight/obesity. We evaluated the results of an educational intervention to promote healthy growth in very young children. Secondarily, we used detailed diet data to explore the association of nutrient intake with the early development of overweight and obesity.
METHODS


Mothers were obese Latina women, enrolled prenatally, and their infants. Specially trained community health workers provided breastfeeding support and nutrition education during 10 home visits, birth to 24 months. At follow-up, age 18 to 36 months, we measured growth and completed detailed diet recalls (1-7 recall days/child).
RESULTS


Of 174 infants randomized, 106 children were followed for 24 to 36 months. The educational intervention did not prevent overweight/obesity. Forty-two percent of children became overweight or obese. Fifty-eight percent of children consumed caffeine on at least 1 recall day. Mean intake was 0.48 mg/kg/day. Caffeine correlated with higher consumption of calories, and added sugar and decreased intake of protein, fiber and dairy. Compared with days without caffeine, on days when caffeine was consumed, children ingested 121 more calories and 3.8 gm less protein. Children frequently consumed less than the recommended daily intake of key nutrients such as fiber, vegetables, whole fruit, and vitamins.
CONCLUSIONS


Caffeine was a marker for increased intake of calories and decreased intake of key nutrients. When discussing dietary intake in early childhood, practitioners should screen for nutrient deficiency in young children and recommend limiting the intake of caffeinated foods and beverages.",2020,"Children frequently consumed less than the recommended daily intake of key nutrients such as fiber, vegetables, whole fruit, and vitamins.
","['106 children were followed for 24-36 months', 'Mothers were obese Latina women, enrolled prenatally, and their infants', 'Young Children', '174 infants randomized', 'Forty-two percent of children became overweight or obese', 'very young children']","['Caffeine', 'Calories, Caffeine', 'educational intervention', 'caffeine']","['higher consumption of calories, and added sugar and decreased intake of protein, fiber and dairy', 'Mean intake', 'overweight/obesity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1879985', 'cui_str': 'calorie'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",174.0,0.0211932,"Children frequently consumed less than the recommended daily intake of key nutrients such as fiber, vegetables, whole fruit, and vitamins.
","[{'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'McCormick', 'Affiliation': 'University of Texas Medical Branch (DP McCormick), Galveston, Tex. Electronic address: david.mccormick@utmb.edu.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Reyna', 'Affiliation': 'College of Nursing and Health Innovation (L Reyna and E Reifsnider), Arizona State University, Phoenix, Ariz.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Reifsnider', 'Affiliation': 'College of Nursing and Health Innovation (L Reyna and E Reifsnider), Arizona State University, Phoenix, Ariz.'}]",Academic pediatrics,['10.1016/j.acap.2020.02.014']
171,32311204,Long-term efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (the DEPICT-2 study): 52-week results from a randomized controlled trial.,"AIM


To investigate the long-term efficacy and safety of dapagliflozin as an adjunct to adjustable insulin in adults with type 1 diabetes (T1D) and inadequate glycaemic control.
MATERIALS AND METHODS


Dapagliflozin Evaluation in Patients with Inadequately Controlled Type 1 Diabetes (DEPICT-2) was a placebo-controlled, double-blind, multicentre, phase III study of adults with T1D (HbA1c 7.5%-10.5%) randomized (1:1:1) to receive dapagliflozin 5, 10 mg, or placebo. The efficacy and safety of dapagliflozin over 52 weeks were exploratory endpoints in this extension to DEPICT-2.
RESULTS


Of 813 participants randomized, 88.2% completed the study. From baseline to 52 weeks, dapagliflozin 5 and 10 mg were associated with reduction in HbA1c (difference [95% CI] vs. placebo: -0.20% [-0.34, -0.06] and -0.25% [-0.38, -0.11], respectively) and adjusted mean percentage change in body weight (difference [95% CI] vs. placebo: -4.42% [-5.19, -3.64] and -4.86% [-5.63, -4.08], respectively). Serious adverse events were reported in the dapagliflozin 5, 10 mg, and placebo groups (32 [11.8%], 19 [7.0%] and 16 [5.9%], respectively). The proportion of hypoglycaemic events was similar across groups; severe hypoglycaemia was uncommon. More participants with events adjudicated as definite diabetic ketoacidosis (DKA) were in the dapagliflozin 5 and 10 mg groups versus placebo (11 [4.1%], 10 [3.7%] and 1 [0.4%], respectively); the majority of events were mild or moderate in severity and all were resolved with treatment.
CONCLUSIONS


Dapagliflozin led to long-term reductions in HbA1c and body weight in adults with T1D, but increased DKA risk compared with placebo.",2020,"From baseline to 52 weeks, dapagliflozin 5 and 10 mg were associated with reduction in HbA 1c  (difference [95% CI] vs. placebo: -0.20% [-0.34, -0.06] and - 0.25% [-0.38, -0.11], respectively) and adjusted mean percentage change in body weight (difference [95% CI] vs. placebo: -4.42% [-5.19, -3.64], and - 4.86% [-5.63, -4.08], respectively).","['813 participants randomized, 88.2% completed the study', 'adults with type 1 diabetes (T1D) and inadequate glycemic control', 'DEPICT-2 (Dapagliflozin Evaluation in Patients with Inadequately Controlled T1D; NCT02460978) was a placebo-controlled, double-blind, multicenter, Phase III study of adults with T1D (HbA 1c  7.5-10.5', 'patients with inadequately controlled type 1 diabetes (the DEPICT-2 study']","['dapagliflozin 5\u2009mg, 10\u2009mg, or placebo', 'dapagliflozin', 'Dapagliflozin', 'placebo']","['definite diabetic ketoacidosis (DKA', 'proportion of hypoglycemic events', 'HbA 1c  and body weight', 'Serious adverse events', 'efficacy and safety', 'DKA risk', 'reduction in HbA 1c', 'severe hypoglycemia', 'body weight']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C3709923', 'cui_str': 'dapagliflozin 5 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}]",813.0,0.500435,"From baseline to 52 weeks, dapagliflozin 5 and 10 mg were associated with reduction in HbA 1c  (difference [95% CI] vs. placebo: -0.20% [-0.34, -0.06] and - 0.25% [-0.38, -0.11], respectively) and adjusted mean percentage change in body weight (difference [95% CI] vs. placebo: -4.42% [-5.19, -3.64], and - 4.86% [-5.63, -4.08], respectively).","[{'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Mathieu', 'Affiliation': 'Clinical and Experimental Endocrinology, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Gottfried', 'Initials': 'G', 'LastName': 'Rudofsky', 'Affiliation': 'Endocrinology and Metabolic Diseases, Cantonal Hospital Olten, Olten, Switzerland.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Phillip', 'Affiliation': ""Institute for Endocrinology and Diabetes, Schneider Children's Medical Center of Israel, Tel-Aviv University, Tel-Aviv, Israel.""}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Araki', 'Affiliation': 'Department of Metabolic Medicine, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Lind', 'Affiliation': 'Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Niki', 'Initials': 'N', 'LastName': 'Arya', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Thorén', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Markus F', 'Initials': 'MF', 'LastName': 'Scheerer', 'Affiliation': 'BioPharmaceuticals Medical, AstraZeneca, Wedel, Germany.'}, {'ForeName': 'Nayyar', 'Initials': 'N', 'LastName': 'Iqbal', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Paresh', 'Initials': 'P', 'LastName': 'Dandona', 'Affiliation': 'Department of Endocrinology, Kaleida Health, Buffalo, New York, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14060']
172,32305477,"Lower Ischemic Heart Disease Diagnostic Costs With Treadmill Stress CMR Versus SPECT: A Multicenter, Randomized Trial.",,2020,,[],['Treadmill Stress CMR vs. SPECT'],[],[],"[{'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0006802', 'cui_str': 'Cameroon'}, {'cui': 'C0040399', 'cui_str': 'Single photon emission computerized tomography'}]",[],,0.0703892,,"[{'ForeName': 'Subha V', 'Initials': 'SV', 'LastName': 'Raman', 'Affiliation': ''}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Hachamovitch', 'Affiliation': ''}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Scandling', 'Affiliation': ''}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Mazur', 'Affiliation': ''}, {'ForeName': 'Raymond Y', 'Initials': 'RY', 'LastName': 'Kwong', 'Affiliation': ''}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'Erik B', 'Initials': 'EB', 'LastName': 'Schelbert', 'Affiliation': ''}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Vien', 'Initials': 'V', 'LastName': 'Truong', 'Affiliation': ''}, {'ForeName': 'Orlando P', 'Initials': 'OP', 'LastName': 'Simonetti', 'Affiliation': ''}]",JACC. Cardiovascular imaging,['10.1016/j.jcmg.2020.02.020']
173,32171768,Frequency of Mass Azithromycin Distribution for Ocular Chlamydia in a Trachoma Endemic Region of Ethiopia: A Cluster Randomized Trial.,"PURPOSE


Annual mass azithromycin distribution significantly reduces the prevalence of ocular Chlamydia trachomatis, the causative organism of trachoma. However, in some areas a decade or more of treatment has not controlled infection. Here, we compared multiple treatment arms from a community-randomized trial to evaluate whether increasing frequency of azithromycin distribution decreases prevalence in the short term.
METHODS


Seventy-two communities in Goncha Siso Enesie woreda in the Amhara region of Northern Ethiopia were randomized to 1 of 6 azithromycin distribution strategies: (1) delayed, (2) annual, (3) biannual, (4) quarterly to children only, (5) biennial, or (6) biennial plus latrine promotion. We analyzed data from the 60 communities in the delayed, annual, biannual, quarterly, and biennial distribution arms at the 12-month study visit. Communities in the annual and biennial distribution arm were combined, as they each had a single distribution before any 12-month retreatment. We assessed the effect of increased frequency of azithromycin distribution on ocular chlamydia prevalence.
RESULTS


Ocular chlamydia prevalence was significantly different across azithromycin distribution frequency in children (P < .0001) and adults (P < .0001), with lower prevalence associated with higher frequency. Among children, quarterly azithromycin distribution led to a significantly greater reduction in ocular chlamydia prevalence than the World Health Organization-recommended annual treatment prevalence (mean difference -11.4%, 95% confidence interval -19.5 to -3.3%, P = .007).
CONCLUSIONS


Increased frequency of azithromycin distribution leads to decreased ocular chlamydia prevalence over a short-term period. In some regions with high levels of ocular chlamydia prevalence, additional azithromycin distributions may help achieve local elimination of infection.",2020,"RESULTS


Ocular chlamydia prevalence was significantly different across azithromycin distribution frequency in children (P<0.0001) and adults (P<0.0001), with lower prevalence associated with higher frequency.","['Seventy-two communities in Goncha Seso Enesie Woreda in the Amhara Region of Northern Ethiopia', '60 communities in the delayed, annual, biannual, quarterly, and biennial distribution arms at the 12-month study visit', 'ocular chlamydia in a trachoma endemic region of Ethiopia']","['azithromycin', 'azithromycin distribution strategies: 1) delayed, 2) annual, 3) biannual, 4) quarterly to children only, 5) biennial, or 6) biennial plus latrine promotion', 'azithromycin distribution']","['ocular chlamydia prevalence', 'Ocular chlamydia prevalence']","[{'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0015024', 'cui_str': 'Federal Democratic Republic of Ethiopia'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0332179', 'cui_str': 'q3mo'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0040592', 'cui_str': 'Egyptian Ophthalmia'}, {'cui': 'C0243130', 'cui_str': 'endemics'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0332179', 'cui_str': 'q3mo'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0023124', 'cui_str': 'Latrines'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",,0.0495108,"RESULTS


Ocular chlamydia prevalence was significantly different across azithromycin distribution frequency in children (P<0.0001) and adults (P<0.0001), with lower prevalence associated with higher frequency.","[{'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, USA; Department of Ophthalmology, University of California, San Francisco, San Francisco, California, USA; Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California, USA. Electronic address: tom.lietman@ucsf.edu.'}, {'ForeName': 'Berhan', 'Initials': 'B', 'LastName': 'Ayele', 'Affiliation': 'The Carter Center Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Teshome', 'Initials': 'T', 'LastName': 'Gebre', 'Affiliation': 'International Trachoma Initiative, Addis Ababa, Ethiopia.'}, {'ForeName': 'Mulat', 'Initials': 'M', 'LastName': 'Zerihun', 'Affiliation': 'The Carter Center Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Zerihun', 'Initials': 'Z', 'LastName': 'Tadesse', 'Affiliation': 'The Carter Center Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Emerson', 'Affiliation': 'International Trachoma Initiative, Atlanta, Georgia, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Nash', 'Affiliation': 'The Carter Center, Atlanta, Georgia, USA.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, USA; Department of Ophthalmology, University of California, San Francisco, San Francisco, California, USA; Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, USA; Department of Ophthalmology, University of California, San Francisco, San Francisco, California, USA; Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, USA; Department of Ophthalmology, University of California, San Francisco, San Francisco, California, USA; Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California, USA.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.02.019']
174,31053766,Androgen decline and survival during docetaxel therapy in metastatic castration resistant prostate cancer (mCRPC).,"BACKGROUND


Multiple androgens drive prostate cancer progression and higher pre-treatment levels of androgens, even within the castrate range, have been previously shown to be associated with an improved overall survival (OS) in mCRPC. Docetaxel impairs microtubules, has androgen receptor (AR) inhibitory effects and is used in both the castration resistant and sensitive settings, where androgen dynamics may impact outcome. The present analysis evaluates the association of decline in serum androgen levels (Testosterone (T), Androstenedione (A) and DHEA in docetaxel-treated mCRPC patients with OS.
METHODS


Data from 1050 men treated on CALGB 90401 with docetaxel, prednisone and either bevacizumab or placebo were evaluated. Eligibility required progressive mCRPC and no prior chemotherapy. Pre-treatment, 6 week and progression serum assays for T, A and DHEA were performed via tandem Liquid Chromatography-Mass Spectrometry (LC-MS/MS). Changes in T, A and DHEA levels from baseline to 6 weeks were calculated as the ratio of 6-week over baseline. The proportional hazards model was used to assess the prognostic significance of changes in T, A, and DHEA from baseline to 6 weeks in predicting OS adjusting for known prognostic factors.
RESULTS


Median baseline values for T, A, and, DHEA were 1.0, 13.5, and 8.1 ng/dL respectively while 6 week levels were 0.64, 7.0, and 6.8 ng/dL respectively. Median OS for low testosterone decline is 20.9 months vs 26.3 months for high testosterone decline. In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001). Decline in A and DHEA were not significant predictors of OS. In multivariable analysis change in the serum changes did not predict PFS however the ratio of T at 6-weeks over baseline was prognostic of ≥50% decline in PSA with an odds ratio of 0.93 (95% CI = 0.85-0.98, p-value = 0.039).
CONCLUSIONS


Declines in testosterone during docetaxel treatment is associated with a longer survival, consistent with a favorable prognostic significance of higher serum androgens in the CRPC.",2020,"In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001).","['Data from 1050 men treated on CALGB 90401 with', 'metastatic castration resistant prostate cancer (mCRPC']","['Docetaxel', 'Androstenedione (A) and DHEA in docetaxel-treated mCRPC', 'docetaxel therapy', 'docetaxel, prednisone and either bevacizumab or placebo']","['testosterone levels', 'Median OS for low testosterone decline', 'serum androgen levels (Testosterone (T', 'overall survival (OS', 'hazard ratio for death', 'Androgen decline and survival', 'Changes in T, A and DHEA levels']","[{'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0002860', 'cui_str': 'androstanedione'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1295654', 'cui_str': 'Decreased testosterone level'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0919646', 'cui_str': 'Androgen level'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.188418,"In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001).","[{'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Ryan', 'Affiliation': 'University of Minnesota and Masonic Cancer Center, Minneapolis, MN, USA. ryanc@umn.edu.'}, {'ForeName': 'Sandipan', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Kelly', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Russell', 'Affiliation': 'University of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'University of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer, New York, NY, USA.'}, {'ForeName': 'Mary-Ellen', 'Initials': 'ME', 'LastName': 'Taplin', 'Affiliation': 'Dana-Farber/Partners Cancer Care, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0152-3']
175,31279324,Effects of hydrocortisone on autobiographical memory retrieval in patients with posttraumatic stress disorder and borderline personality disorder: the role of childhood trauma.,"In a previous study, we found that patients with posttraumatic stress disorder (PTSD) and borderline personality disorder (BPD) showed better autobiographical memory (AM) retrieval after hydrocortisone administration than after placebo administration. Here we investigate the neural correlates of AM retrieval after hydrocortisone administration in patients with PTSD or BPD. We recruited 78 female participants for this placebo-controlled crossover study: 40 healthy controls, 20 patients with PTSD, and 18 patients with BPD (all without medication). All participants received an oral placebo or 10 mg hydrocortisone in a randomized order before performing an AM task. Neural activity was monitored during the task by functional magnetic resonance imaging. Neural activation did not differ between the three groups during AM retrieval, neither in the placebo condition nor after hydrocortisone intake. Multiple regression analysis revealed that Childhood Trauma Questionnaire scores correlated positively with hydrocortisone effects on activation in the anterior medial prefrontal cortex (amPFC), ventrolateral prefrontal cortex (vlPFC), posterior cingulate cortex (PCC), angular gyrus, and cerebellum. These results suggest that hydrocortisone-induced neural activation pattern during AM retrieval is related to childhood trauma. Previously described effects in the hippocampus, which were absent in the current study, might be related to PTSD caused by trauma in adulthood. The effects of hydrocortisone on brain activation and how these effects are influenced by childhood trauma, trauma in adulthood, and PTSD symptoms should be determined in future studies.",2019,"Neural activation did not differ between the three groups during AM retrieval, neither in the placebo condition nor after hydrocortisone intake.","['patients with PTSD or BPD', 'patients with posttraumatic stress disorder (PTSD) and borderline personality disorder (BPD', '78 female participants for this placebo-controlled crossover study: 40 healthy controls, 20 patients with PTSD, and 18 patients with BPD (all without medication', 'patients with posttraumatic stress disorder and borderline personality disorder']","['oral placebo', 'hydrocortisone']","['Neural activation', 'autobiographical memory retrieval', 'Childhood Trauma Questionnaire scores', 'autobiographical memory (AM) retrieval', 'anterior medial prefrontal cortex (amPFC), ventrolateral prefrontal cortex (vlPFC), posterior cingulate cortex (PCC), angular gyrus, and cerebellum', 'brain activation', 'Neural activity', 'neural activation pattern']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]","[{'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C3266730', 'cui_str': 'Ventrolateral'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C0152305', 'cui_str': 'Prelunate Gyrus'}, {'cui': 'C0007765', 'cui_str': 'Parencephalon'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",78.0,0.0472001,"Neural activation did not differ between the three groups during AM retrieval, neither in the placebo condition nor after hydrocortisone intake.","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Metz', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany. sophie.metz@charite.de.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Fleischer', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Gärnter', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Golde', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Duesenberg', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Roepke', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Wolf', 'Affiliation': 'Department of Cognitive Psychology, Institute of Cognitive Neuroscience, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wingenfeld', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0459-8']
176,32301973,Corneal Stroma Cell Density Evolution in Keratoconus Corneas Following the Implantation of Adipose Mesenchymal Stem Cells and Corneal Laminas: An In Vivo Confocal Microscopy Study.,"Purpose


To report the corneal stroma cell density evolution identified by in vivo corneal confocal microscopy in humans using injected autologous adipose-derived adult stem cells (ADASCs) and corneal decellularized laminas in corneas with advanced keratoconus.
Methods


Interventional prospective, consecutive, randomized, comparative series of cases. A total of 14 keratoconic patients were randomly distributed into three groups for three types of surgical interventions: group 1 (G-1), autologous ADASC implantation (n = 5); group 2 (G-2), decellularized human corneal stroma (n = 5); and group 3 (G-3), autologous ADASCs + decellularized human corneal stroma (n = 4).
Results


A gradual and significant increase (P < 0.001) was observed in the cellularity in the anterior and posterior stroma of patients in G-1, G-2, and G-3 a year after the surgery in comparison with the preoperative density level. The same result was observed at the mid-corneal stroma in G-1 and at the anterior and posterior surfaces and within the laminas in G-2 and G-3. The cell density of patients receiving ADASC recellularized laminas (G-3) was statistically significantly higher (P = 0.011) at the anterior surface and within the lamina (P = 0.029) and at the posterior surface than in those implanted only with decellularized laminas (G-2).
Conclusions


A significant increase in cell density occurred up to 1 postoperative year at the corneal stroma following the implantation of ADASCs alone, as well as in those cases implanted with decellularized and recellularized laminas at the different levels of the analysis. However, this increase was significantly higher in the ADASC recellularized laminas.",2020,"The cell density of patients receiving ADASC recellularized laminas (G-3) was statistically significantly higher (P = 0.011) at the anterior surface and within the lamina (P = 0.029) and at the posterior surface than in those implanted only with decellularized laminas (G-2).
","['humans using injected autologous adipose-derived adult stem cells (ADASCs) and corneal decellularized laminas in corneas with advanced keratoconus', '14 keratoconic patients', 'Adipose Mesenchymal Stem Cells and Corneal Laminas']","['surgical interventions: group 1 (G-1), autologous ADASC implantation (n = 5); group 2 (G-2), decellularized human corneal stroma (n = 5); and group 3 (G-3), autologous ADASCs + decellularized human corneal stroma (n = 4']","['cell density of patients receiving ADASC recellularized laminas (G-3', 'cell density']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1636199', 'cui_str': 'Adipose derived adult stem cell'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0010040', 'cui_str': 'Structure of substantia propria of cornea'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C1636199', 'cui_str': 'Adipose derived adult stem cell'}]","[{'cui': 'C0162339', 'cui_str': 'Cell Density'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}]",14.0,0.0181501,"The cell density of patients receiving ADASC recellularized laminas (G-3) was statistically significantly higher (P = 0.011) at the anterior surface and within the lamina (P = 0.029) and at the posterior surface than in those implanted only with decellularized laminas (G-2).
","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'El Zarif', 'Affiliation': ',.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'A Jawad', 'Affiliation': ',.'}, {'ForeName': 'Jorge L', 'Initials': 'JL', 'LastName': 'Alió Del Barrio', 'Affiliation': ',.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'A Jawad', 'Affiliation': ',.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Palazón-Bru', 'Affiliation': ',.'}, {'ForeName': 'María P', 'Initials': 'MP', 'LastName': 'de Miguel', 'Affiliation': ',.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Saba', 'Affiliation': ',.'}, {'ForeName': 'Nehman', 'Initials': 'N', 'LastName': 'Makdissy', 'Affiliation': ',.'}, {'ForeName': 'Jorge L', 'Initials': 'JL', 'LastName': 'Alió', 'Affiliation': ',.'}]",Investigative ophthalmology & visual science,['10.1167/iovs.61.4.22']
177,32182879,Botulinum Toxin Therapy for Managing Sleep Bruxism: A Randomized and Placebo-Controlled Trial.,"The purpose of this study is to evaluate the effects of botulinum toxin type A (BoNT-A) for managing sleep bruxism (SB) in a randomized, placebo-controlled trial. Thirty SB subjects were randomly assigned into two groups evenly. The placebo group received saline injections into each masseter muscle, and the treatment group received BoNT-A injections into each masseter muscle. Audio-video-polysomnographic recordings in the sleep laboratory were made before, at four weeks after, and at 12 weeks after injection. Sleep and SB parameters were scored according to the diagnostic and coding manual of American Academy of Sleep Medicine. The change of sleep and SB parameters were investigated using repeated measures analysis of variance (RM-ANOVA). Twenty-three subjects completed the study (placebo group 10, treatment group 13). None of the SB episode variables showed a significant time and group interaction ( p  > 0.05) except for electromyography (EMG) variables. The peak amplitude of EMG bursts during SB showed a significant time and group interaction ( p  = 0.001). The injection decreased the peak amplitude of EMG bursts during SB only in the treatment group for 12 weeks ( p  < 0.0001). A single BoNT-A injection cannot reduce the genesis of SB. However, it can be an effective management option for SB by reducing the intensity of the masseter muscle.",2020,The peak amplitude of EMG bursts during SB showed a significant time and group interaction ( p  = 0.001).,"['Managing Sleep Bruxism', 'Twenty-three subjects completed the study ', 'Thirty SB subjects']","['placebo', 'botulinum toxin type A (BoNT-A', 'Botulinum Toxin Therapy', 'saline injections', 'Placebo', 'Audio-video-polysomnographic recordings']","['Sleep and SB parameters', 'peak amplitude of EMG bursts during SB', 'peak amplitude of EMG bursts', 'change of sleep and SB parameters']","[{'cui': 'C0751771', 'cui_str': 'Bruxism, Nocturnal'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C2930113', 'cui_str': 'incobotulinumtoxinA'}, {'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",30.0,0.124348,The peak amplitude of EMG bursts during SB showed a significant time and group interaction ( p  = 0.001).,"[{'ForeName': 'Young Joo', 'Initials': 'YJ', 'LastName': 'Shim', 'Affiliation': 'Department of Oral Medicine, College of Dentistry, Wonkwang University, Daejeon 35233, Korea.'}, {'ForeName': 'Hee Jin', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Orofacial Pain and Oral Medicine, Yonsei University Dental Hospital, Seoul 03722, Korea.'}, {'ForeName': 'Keun Jeong', 'Initials': 'KJ', 'LastName': 'Park', 'Affiliation': 'Department of Orofacial Pain and Oral Medicine, Yonsei University Dental Hospital, Seoul 03722, Korea.'}, {'ForeName': 'Hyung Tack', 'Initials': 'HT', 'LastName': 'Kim', 'Affiliation': 'TMJ & Orofacial Pain Clinic, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Il Hee', 'Initials': 'IH', 'LastName': 'Hong', 'Affiliation': 'Seoul Sleep Clinic, Seoul 06052, Korea.'}, {'ForeName': 'Seong Taek', 'Initials': 'ST', 'LastName': 'Kim', 'Affiliation': 'Department of Orofacial Pain and Oral Medicine, College of Dentistry, Yonsei University, Seoul 03722, Korea.'}]",Toxins,['10.3390/toxins12030168']
178,32308190,Testing the efficacy of and parents' preferences for nutrition labels on children's menus from a full-service chain restaurant: results of an online experiment.,"OBJECTIVE


Test the efficacy and perceived effectiveness of nutrition labels on children's menus from a full-service chain restaurant in an online study.
DESIGN


Using a between-groups experiment, parents were randomised to view children's menus displaying one of five children's nutrition labelling conditions: (i) No Nutrition Information (control); (ii) Calories Only; (iii) Calories + Contextual Statement (CS); (iv) Calories, Sodium + CS; or (v) Calories and Sodium in Traffic Lights + CS. Parents hypothetically ordered up to one entrée, side, beverage and dessert for their child, then rated and ranked all five labelling conditions on the level of perceived effectiveness.
SETTING


Online survey.
PARTICIPANTS


998 parents with a 3-12 year old child.
RESULTS


Parents exposed to menus displaying 'Calories, Sodium + CS' selected significantly fewer calories 'overall' (entrées + side + dessert + beverage) compared to parents exposed to the control condition (-53·1 calories, P < 0·05). Parents selected 'entrees' with significantly fewer calories and lower sodium when exposed to menus with 'Calories + CS' (-24·3 calories, P < 0·05); 'Calories, Sodium + CS' (-25·4 calories, -56·1 mg sodium, P < 0·05 for both); and 'Calories and Sodium in Traffic Lights + CS' (-29·1 calories, -58·6 mg sodium, P < 0·05 for both). Parents exposed to menus with 'Calories, Sodium + CS' and 'Calories and Sodium in Traffic Lights + CS' were more likely to notice and understand nutrition information compared to other nuntrition labelling conditions. Parents perceived the menu with 'Calories and Sodium in Traffic Lights + CS' as most effective (P < 0·05).
CONCLUSIONS


Menus disclosing calories, sodium and a contextual statement increased the proportion of parents who noticed and understood nutrition information, and resulted in parents selecting lower calorie and sodium entrées for their children in the hypothetical purchase task.",2020,"RESULTS


Parents exposed to menus displaying 'Calories, Sodium + CS' selected significantly fewer calories 'overall' (entrées + side + dessert + beverage) compared to parents exposed to the control condition (-53·1 calories, P < 0·05).","['998 parents with a 3-12 year old child', ""children's menus from a full-service chain restaurant in an online study"", ""children's menus from a full-service chain restaurant""]","['Calories + Contextual Statement (CS', 'nutrition labels', 'Nutrition Information (control', 'iv) Calories, Sodium + CS; or (v) Calories and Sodium in Traffic Lights + CS', ""view children's menus displaying one of five children's nutrition labelling conditions: (i"", ""Calories, Sodium + CS' and 'Calories and Sodium in Traffic Lights + CS""]","[""calories 'overall""]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0035255', 'cui_str': 'Restaurant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0028711', 'cui_str': 'Nutrition Labeling'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0442664', 'cui_str': 'Traffic light'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1720755', 'cui_str': 'Child nutrition'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",998.0,0.0175147,"RESULTS


Parents exposed to menus displaying 'Calories, Sodium + CS' selected significantly fewer calories 'overall' (entrées + side + dessert + beverage) compared to parents exposed to the control condition (-53·1 calories, P < 0·05).","[{'ForeName': 'Rachel J L', 'Initials': 'RJL', 'LastName': 'Prowse', 'Affiliation': 'Public Health Ontario, 480 University Ave, Suite 300, Toronto, ONM5G 1V2, Canada.'}, {'ForeName': 'Kirsten M', 'Initials': 'KM', 'LastName': 'Lee', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, 200 University Ave West, Waterloo, ONN2L 3G1, Canada.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Chen', 'Affiliation': 'Public Health Ontario, 480 University Ave, Suite 300, Toronto, ONM5G 1V2, Canada.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zuo', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, 30 Bond St., Toronto, ONM5B 1W8, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hammond', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, 200 University Ave West, Waterloo, ONN2L 3G1, Canada.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Hobin', 'Affiliation': 'Public Health Ontario, 480 University Ave, Suite 300, Toronto, ONM5G 1V2, Canada.'}]",Public health nutrition,['10.1017/S1368980019004488']
179,32164382,Efficacy of Divinylbenzenic Resin in Removing Indoxyl Sulfate and P-Cresol Sulfate in Hemodialysis Patients: Results From an In Vitro Study and An In Vivo Pilot Trial (xuanro4-Nature 3.2).,"High serum levels of microbiota-derived uremic toxins, indoxyl sulfate (IS) and p-cresyl sulfate (PCS), are associated with chronic kidney disease (CKD) progression and cardiovascular complications. IS and PCS cannot be efficiently removed by conventional hemodialysis (HD), due to their high binding affinity for albumin. This study evaluates the efficacy of a divinylbenzene-polyvinylpyrrolidone (DVB-PVP) cartridge and a synbiotic to reduce uremic toxins in HD patients. First, the in vitro efficacy of DVB-PVP in adsorbing IS and PCS was evaluated. Second, a randomized, placebo-controlled pilot study in HD patients was carried out to establish whether the administration of a synbiotic, either individually and in association with DVB-PVP-HD, could reduce the production of uremic toxins. In vitro data showed that DVB-PVP resin removed a mean of 56% PCS and around 54% IS, after 6 h of perfusion. While, in the in vivo study, the DVB-PVP cartridge showed its adsorbing efficacy only for IS plasma levels. The combination of synbiotic treatment with DVB-PVP HD decreased IS and PCS both at pre- and post-dialysis levels. In conclusion, this study provides the first line of evidence on the synergistic action of gut microbiota modulation and an innovative absorption-based approach in HD patients, aimed at reducing plasma levels of IS and PCS.",2020,"High serum levels of microbiota-derived uremic toxins, indoxyl sulfate (IS) and p-cresyl sulfate (PCS), are associated with chronic kidney disease (CKD) progression and cardiovascular complications.","['Hemodialysis Patients', 'HD patients']","['DVB-PVP', 'placebo', 'Divinylbenzenic Resin', 'divinylbenzene-polyvinylpyrrolidone (DVB-PVP) cartridge and a synbiotic', 'DVB-PVP HD']",['uremic toxins'],"[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0058515', 'cui_str': 'divinylbenzene'}, {'cui': 'C0032856', 'cui_str': 'Povidone'}, {'cui': 'C4319642', 'cui_str': 'Cartridge (unit of presentation)'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}]","[{'cui': 'C4522020', 'cui_str': 'Toxin'}]",,0.022605,"High serum levels of microbiota-derived uremic toxins, indoxyl sulfate (IS) and p-cresyl sulfate (PCS), are associated with chronic kidney disease (CKD) progression and cardiovascular complications.","[{'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Rocchetti', 'Affiliation': 'Nephrology, Dialysis and Transplantation Unit, Department of Emergency and Organ Transplantation, ""AldoMoro"" University, 70124 Bari, Italy.'}, {'ForeName': 'Carmela', 'Initials': 'C', 'LastName': 'Cosola', 'Affiliation': 'Nephrology, Dialysis and Transplantation Unit, Department of Emergency and Organ Transplantation, ""AldoMoro"" University, 70124 Bari, Italy.'}, {'ForeName': 'Ighli', 'Initials': 'I', 'LastName': 'di Bari', 'Affiliation': 'Nephrology, Dialysis and Transplantation Unit, Department of Emergency and Organ Transplantation, ""AldoMoro"" University, 70124 Bari, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Magnani', 'Affiliation': 'Aferetica SRL, 40138 Bologna, Italy.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Galleggiante', 'Affiliation': 'Aferetica SRL, 40138 Bologna, Italy.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Scandiffio', 'Affiliation': 'Aferetica SRL, 40138 Bologna, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Dalfino', 'Affiliation': 'Nephrology, Dialysis and Transplantation Unit, Department of Emergency and Organ Transplantation, ""AldoMoro"" University, 70124 Bari, Italy.'}, {'ForeName': 'Giuseppe Stefano', 'Initials': 'GS', 'LastName': 'Netti', 'Affiliation': 'Clinical Pathology Unit and Center for Molecular Medicine, Department of Medical and Surgical Sciences, University of Foggia, 71122 Foggia, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Atti', 'Affiliation': 'Aferetica SRL, 40138 Bologna, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Corciulo', 'Affiliation': 'Nephrology, Dialysis and Transplantation Unit, Department of Emergency and Organ Transplantation, ""AldoMoro"" University, 70124 Bari, Italy.'}, {'ForeName': 'Loreto', 'Initials': 'L', 'LastName': 'Gesualdo', 'Affiliation': 'Nephrology, Dialysis and Transplantation Unit, Department of Emergency and Organ Transplantation, ""AldoMoro"" University, 70124 Bari, Italy.'}]",Toxins,['10.3390/toxins12030170']
180,31611635,A pilot trial of pembrolizumab plus prostatic cryotherapy for men with newly diagnosed oligometastatic hormone-sensitive prostate cancer.,"BACKGROUND


Monotherapy with immune checkpoint inhibitors has generally been unsuccessful in men with advanced prostate cancer. Preclinical data support the notion that cryotherapy may improve immune-mediated and anti-tumor responses. The objective of this study was to assess the safety and feasibility of whole-prostate gland cryotherapy combined with pembrolizumab and androgen deprivation in men with oligometastatic hormone-sensitive prostate cancer.
METHODS


This single-institution, pilot trial recruited 12 patients with newly diagnosed oligometastatic prostate cancer between 2015 and 2016. Patients underwent whole-prostate cryoablation combined with short-term androgen deprivation (eight months) and pembrolizumab (6 doses). The primary clinical endpoints were the number of patients with a PSA level of <0.6 ng/mL at one year and the frequency of adverse events. Other outcome measures included progression-free survival and systemic therapy-free survival. Exploratory analyses included PD-L1 protein expression.
RESULTS


Forty two percent (5/12) of patients had a PSAs of <0.6 ng/mL at one year though only 2 of these patients had recovered their testosterone at this time point. Median progression-free survival was 14 months, and median systemic therapy-free survival was 17.5 months. PD-L1 expression was not detectable by IHC in patients with evaluable tissue. All adverse events were grade ≤2, and there were no apparent complications from cryotherapy.
CONCLUSIONS


Whole-prostate cryoablation combined with short-term androgen deprivation and pembrolizumab treatment was well tolerated and no safety concerns were observed in men with oligometastatic prostate cancer. Though local disease appeared effectively treated in the majority of men, the regimen only infrequency led to sustained disease control following testosterone recovery.",2020,"All adverse events were grade ≤2, and there were no apparent complications from cryotherapy.
","['12 patients with newly diagnosed oligometastatic prostate cancer between 2015 and 2016', 'men with oligometastatic hormone-sensitive prostate cancer', 'patients with evaluable tissue', 'men with newly diagnosed oligometastatic hormone-sensitive prostate cancer', 'men with advanced prostate cancer', 'men with oligometastatic prostate cancer']","['pembrolizumab plus prostatic cryotherapy', 'whole-prostate cryoablation combined with short-term androgen deprivation (eight months) and pembrolizumab', 'whole-prostate gland cryotherapy combined with pembrolizumab and androgen deprivation', 'Whole-prostate cryoablation combined with short-term androgen deprivation and pembrolizumab']","['frequency of adverse events', 'Median progression-free survival', 'tolerated and no safety concerns', 'safety and feasibility', 'progression-free survival and systemic therapy-free survival', 'number of patients with a PSA level', 'median systemic therapy-free survival', 'PD-L1 protein expression', 'PD-L1 expression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0843747', 'cui_str': 'Prostate cryoablation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",,0.114774,"All adverse events were grade ≤2, and there were no apparent complications from cryotherapy.
","[{'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Ross', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA. ashley.ross@usoncology.com.'}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Hurley', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Phuoc T', 'Initials': 'PT', 'LastName': 'Tran', 'Affiliation': 'The Sidney Kimmel Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Rowe', 'Affiliation': 'The Russell H. Morgan Department of Radiology and Radiological Sciences, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Benzon', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': ""Tanya O'"", 'Initials': 'TO', 'LastName': 'Neal', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Chapman', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Harb', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Milman', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Bruce J', 'Initials': 'BJ', 'LastName': 'Trock', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Drake', 'Affiliation': 'The Department of Medicine, Columbia University, New York, NY, USA.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0176-8']
181,30614649,"Steroid pretreatment of organ donors does not impact on early rejection and long-term kidney allograft survival: Results from a multicenter randomized, controlled trial.","Steroid pretreatment of deceased donors reduces inflammation in allografts and is recommended by organ procurement guidelines. The impact on long-term graft outcome, however, remains elusive. In this multicenter randomized controlled trial, 306 deceased donors providing organs for 455 renal transplant recipients were randomized to 1000 mg of methylprednisolone or placebo prior to organ procurement (ISRCTN78828338). The incidence of biopsy-confirmed rejection (Banff>1) at 3 months was 23 (10%) in the steroid group and 26 (12%) in the placebo group (P = .468). Five-year functional graft survival was 84% and 82% for the steroid group and placebo group, respectively (P-value = .941). The hazard ratio of functional graft loss was 0.90 (95% confidence interval 0.57-1.42, P = .638) for steroid vs placebo in a multivariate Cox model. We did not observe effect modification by any of the predictors of graft survival and treatment modality. A robust sandwich estimate was used to account for paired grafts of some donors. The mean estimated GFR at 5 years was 47 mL/min per 1.73 m 2  in the steroid group and 48 mL/min per 1.73 m 2  in the placebo group (P = .756). We conclude that steroid pretreatment does not impact on long-term graft survival. In a donor population with higher risk of delayed graft function, however, repetitive and higher doses of steroid treatment may result in different findings.",2019,"The hazard ratio of functional graft loss was 0.90 (95% confidence interval 0.57-1.42, P = .638) for steroid vs placebo in a multivariate Cox model.",['306 deceased donors providing organs for 455 renal transplant recipients'],"['steroid', 'steroid vs placebo', 'placebo', 'methylprednisolone or placebo']","['graft survival', 'early rejection and long-term kidney allograft survival', 'hazard ratio of functional graft loss', 'incidence of biopsy-confirmed rejection', 'long-term graft survival', 'functional graft survival']","[{'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}]","[{'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]","[{'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}]",306.0,0.536171,"The hazard ratio of functional graft loss was 0.90 (95% confidence interval 0.57-1.42, P = .638) for steroid vs placebo in a multivariate Cox model.","[{'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Reindl-Schwaighofer', 'Affiliation': 'Department of Nephrology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kainz', 'Affiliation': 'Department of Nephrology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Kira', 'Initials': 'K', 'LastName': 'Jelencsics', 'Affiliation': 'Department of Nephrology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Heinzel', 'Affiliation': 'Department of Nephrology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Berlakovich', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ádám', 'Initials': 'Á', 'LastName': 'Remport', 'Affiliation': 'Department of Nephrology, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Heinze', 'Affiliation': 'Center for Medical Statistics, Informatics and Intelligent Systems (CEMSIIS), Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Langer', 'Affiliation': 'Department of Surgery, Elisabethinen Krankenhaus, Linz, Austria.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Oberbauer', 'Affiliation': 'Department of Nephrology, Medical University of Vienna, Vienna, Austria.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.15252']
182,30615259,A randomized trial of everolimus-based quadruple therapy vs standard triple therapy early after lung transplantation.,"Calcineurin inhibitor (CNI) therapy after lung transplantation increases risk of kidney failure. Early everolimus-based quadruple low CNI immunosuppression may improve renal function without compromising efficacy or safety. A prospective, randomized, open-label, 12-month multicenter trial was conducted at 8 German sites. Patients 3-18 months after lung transplantation were randomized (1:1), stratified by baseline estimated glomerular filtration rate (eGFR). In the quadruple low CNI regimen, patients received everolimus (target trough level 3-5 ng/mL) with reduced CNI (tacrolimus 3-5 ng/mL or cyclosporine 25-75 ng/mL) and a cell cycle inhibitor plus prednisone. In the standard triple CNI regimen, patients received tacrolimus (target trough level >5 ng/mL) or cyclosporine (>100 ng/mL) and a cell cycle inhibitor plus prednisone. Of the 180 patients screened, 130 were randomized: 67 in the quadruple low CNI group and 63 in the standard triple CNI group. The primary endpoint (eGFR after 12 months) demonstrated superiority of the quadruple low CNI regimen: 64.5 mL/min vs 54.6 mL/min for the standard triple group (least squares mean, analysis of covariance; P < .001). Key efficacy parameters (biopsy-proven acute rejection, chronic lung allograft dysfunction, and death) and safety endpoints were similar between both groups. Quadruple low CNI immunosuppression early after lung transplantation was demonstrated to be efficacious and safe. Clinical trials registry: ClinicalTrials.gov NCT01404325.",2019,The primary endpoint (eGFR after 12 months) demonstrated superiority of the quadruple low CNI regimen: 64.5 mL/min vs 54.6 mL/min for the standard triple group,"['Patients 3-18\xa0months after lung transplantation', '180 patients screened, 130 were randomized: 67 in the quadruple low CNI group and 63 in the standard triple CNI group', 'early after lung transplantation']","['everolimus', 'cyclosporine', 'Calcineurin inhibitor (CNI) therapy', 'cell cycle inhibitor plus prednisone', 'Early everolimus-based quadruple low CNI immunosuppression', 'everolimus-based quadruple therapy vs standard triple therapy', 'reduced CNI (tacrolimus 3-5\xa0ng/mL or cyclosporine', 'tacrolimus (target trough level']","['renal function', 'Key efficacy parameters (biopsy-proven acute rejection, chronic lung allograft dysfunction, and death) and safety endpoints', 'glomerular filtration rate (eGFR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0024128', 'cui_str': 'Grafting, Lung'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0205175', 'cui_str': 'Quadruple (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0007586', 'cui_str': 'Cell Division Cycle'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205175', 'cui_str': 'Quadruple (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0021080', 'cui_str': 'Immunosuppression (Physiology)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}]",130.0,0.111066,The primary endpoint (eGFR after 12 months) demonstrated superiority of the quadruple low CNI regimen: 64.5 mL/min vs 54.6 mL/min for the standard triple group,"[{'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Respiratory Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Neurohr', 'Affiliation': 'Grosshadern Medical Clinic and Policlinic V, LMU Munich University Hospital, Munich, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Müller-Quernheim', 'Affiliation': 'Pulmonology Medical Clinic, Freiburg University Hospital, Freiburg, Germany.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wirtz', 'Affiliation': 'Internal Medicine/Department of Pneumology, Leipzig University Hospital, Leipzig, Germany.'}, {'ForeName': 'Bjoern', 'Initials': 'B', 'LastName': 'Sill', 'Affiliation': 'Department of Cardiovascular Surgery, Hamburg-Eppendorf University Hospital, Hamburg, Germany.'}, {'ForeName': 'Heinrike', 'Initials': 'H', 'LastName': 'Wilkens', 'Affiliation': 'Internal Medicine V, University Hospital of Saarland, Homburg Saar, Germany.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Bessa', 'Affiliation': 'Department of Pneumology, Ruhrlandklinik, West German Center for Lung Transplantation, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Knosalla', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, German Heart Institute Berlin, DZHK (German Center for Cardiovascular Research), Berlin, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Porstner', 'Affiliation': 'Novartis Pharma GmbH, Nuremberg, Germany.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Capusan', 'Affiliation': 'Novartis Pharma GmbH, Nuremberg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Strüber', 'Affiliation': ""Department of Cardiothoracic Surgery, Newark Beth Israel Medical Center, Children's Hospital of New Jersey, Newark, New Jersey.""}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.15251']
183,32314464,"Comparison of tofogliflozin versus glimepiride as the third oral agent added to metformin plus a dipeptidyl peptidase-4 inhibitor in Japanese patients with type 2 diabetes: A randomized, 24-week, open-label, controlled trial (STOP-OB).","Metformin plus a dipeptidyl peptidase-4 inhibitor (DPP-4i) is the most common therapy for Japanese patients with type 2 diabetes. This 24-week, multicentre, open-label, parallel-group trial randomized patients on dual therapy to add-on tofogliflozin (20 mg/day, n = 33) or glimepiride (0.5 mg/day, n = 31). The primary outcome was change in body fat percentage. The secondary outcomes included changes in HbA1c, fat mass, fat-free mass, liver function variables and uric acid. Tofogliflozin and glimepiride reduced HbA1c to a similar extent. Body fat percentage did not change from baseline in either group. Fat mass was reduced by tofogliflozin but was increased by glimepiride (by -2.0 ± 1.7 kg and +1.6 ± 1.6 kg, P = .002). Fat-free mass was also reduced by tofogliflozin and increased by glimepiride (by -1.3 ± 1.3 kg and +0.9 ± 2.0 kg, P < .001). Alanine aminotransferase and uric acid levels were reduced by tofogliflozin (P = .006 and P < .001, respectively). These data provide novel information useful for selecting the third oral agent for patients whose diabetes is inadequately controlled with metformin plus DPP-4i dual therapy.",2020,"Alanine aminotransferase and uric acid levels were reduced by tofogliflozin (p = 0.006 and p < 0.001, respectively).","['Japanese type 2 diabetes patients', 'Japanese patients with type 2 diabetes mellitus']","['metformin plus DPP-4 inhibitor', 'tofogliflozin versus glimepiride', 'glimepiride', 'Tofogliflozin and glimepiride', 'dual therapy to add-on tofogliflozin', 'Metformin plus a dipeptidyl peptidase-4 inhibitor (DPP-4i']","['changes in HbA1c, fat mass, fat-free mass, liver function parameters and uric acid', 'change in body fat percentage', 'Fat mass', 'Fat-free mass', 'Body fat percentage', 'Alanine aminotransferase and uric acid levels']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}]",,0.0369297,"Alanine aminotransferase and uric acid levels were reduced by tofogliflozin (p = 0.006 and p < 0.001, respectively).","[{'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Kitazawa', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Seino', 'Affiliation': 'Seino Internal Medicine Clinic, Koriyama, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ohashi', 'Affiliation': 'Internal Medicine, Oyama East Clinic, Oyama, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Inazawa', 'Affiliation': 'Department of Endocrinology and Metabolism, Kashiwa City Hospital, Kashiwa, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Inoue', 'Affiliation': 'Sasazuka Inoue Clinic, Tokyo, Japan.'}, {'ForeName': 'Masumi', 'Initials': 'M', 'LastName': 'Ai', 'Affiliation': 'Tanaka Clinic, Wako, Japan.'}, {'ForeName': 'Midori', 'Initials': 'M', 'LastName': 'Fujishiro', 'Affiliation': 'Division of Diabetes and Metabolism, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hisamoto', 'Initials': 'H', 'LastName': 'Kuroda', 'Affiliation': 'Green Clinic, Mibu, Japan.'}, {'ForeName': 'Masayo', 'Initials': 'M', 'LastName': 'Yamada', 'Affiliation': 'Division of Metabolism and Endocrinology, Department of Internal Medicine, Yokohama Sakae Kyosai Hospital, Yokohama, Japan.'}, {'ForeName': 'Motonobu', 'Initials': 'M', 'LastName': 'Anai', 'Affiliation': 'Research Center for Advanced Science and Technology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Hisamitsu', 'Initials': 'H', 'LastName': 'Ishihara', 'Affiliation': 'Division of Diabetes and Metabolism, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14059']
184,32314501,Effectiveness of individual face-to-face exercise counselling in changing exercise behaviours to relieve symptom distress in pregnant women.,"AIM


The present study aimed to evaluate the effectiveness of individualized exercise counselling in changing exercise behaviour and relieving pregnancy-related distress symptoms in pregnant women.
METHODS


A quasi-experimental design and convenience sampling technique were used. Participants were recruited from the prenatal outpatient departments of medical centre hospitals in Taipei, Taiwan. The experimental group (n = 52) received face-to-face exercise counselling followed by 8 weeks of exercise sessions in their homes. The control group (n = 49) received no exercise counselling. Pregnancy-related distress symptoms were assessed before and after 8 weeks in both groups.
RESULTS


The after-counselling scores of total (t = 2.46, P < 0.05) and physical (t = 3.18, P < 0.01) distress symptoms were significantly lower than the before-counselling scores in the experimental group. The total, physical and psychological distress scores significantly differed between groups and before and after counselling. The adjusted R 2  values for total, physical and psychological distress symptoms ranged from 0.59 to 0.70. Participants' exercise habits increased from prepregnancy (19.2%) to after counselling (71.2%).
CONCLUSION


Exercise counselling may effectively increase exercise habits and reduce pregnancy-related distress symptoms among pregnant women. Women with higher pretest symptom distress scores also had higher posttest symptom distress scores. Based on our outcomes, health care providers should routinely provide exercise counselling to pregnant women.",2020,"The after-counselling scores of total (t = 2.46, P < 0.05) and physical (t = 3.18, P < 0.01)","['pregnant women', 'Participants were recruited from the prenatal outpatient departments of medical centre hospitals in Taipei, Taiwan']","['individualized exercise counselling', 'individual face-to-face exercise counselling', 'Exercise counselling', 'no exercise counselling', 'face-to-face exercise counselling followed by 8 weeks of exercise sessions']","['exercise habits', 'symptom distress', 'exercise habits and reduce pregnancy-related distress symptoms', 'distress symptoms', 'total, physical and psychological distress symptoms', 'Pregnancy-related distress symptoms', 'total, physical and psychological distress scores']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0359381,"The after-counselling scores of total (t = 2.46, P < 0.05) and physical (t = 3.18, P < 0.01)","[{'ForeName': 'Ching-Fang', 'Initials': 'CF', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Mackay Medical College, New Taipei, Taiwan.'}, {'ForeName': 'Yao-Chung', 'Initials': 'YC', 'LastName': 'Huang', 'Affiliation': 'Physical Education Office, National Taipei University of Technology, Taipei, Taiwan.'}, {'ForeName': 'Fur-Hsing', 'Initials': 'FH', 'LastName': 'Wen', 'Affiliation': 'Department of International Business, Soochow University, Taipei, Taiwan.'}, {'ForeName': 'Chen-Ju', 'Initials': 'CJ', 'LastName': 'Lin', 'Affiliation': 'Department of Obstetrics and Gynecology, Mackay Memorial Hospital, New Taipei, Taiwan.'}, {'ForeName': 'Li-Kang', 'Initials': 'LK', 'LastName': 'Chi', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Chun-Wei', 'Initials': 'CW', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, Fu Jen Catholic University Hospital, Fu Jen Catholic University, New Taipei City, Taiwan.'}]",International journal of nursing practice,['10.1111/ijn.12837']
185,32187789,Does Pain Neuroscience Education and Cognition-Targeted Motor Control Training Improve Cervical Motor Output? Secondary Analysis of a Randomized Clinical Trial.,"BACKGROUND


In the context of interventions aimed at reducing pain, disability, and maladaptive pain cognitions in chronic neck pain, it is hypothesized that patients who have greater symptom reduction possibly also demonstrate greater improvement in cervical motor output. Therefore, the aim of this study was to examine the effect of pain neuroscience education plus cognition-targeted motor control training on cervical motor output.
METHODS


Impairments in cervical motor output were measured in 64 subjects with chronic neck pain using standardized tests. Cervical muscle strength, cervical mobility, balance, and cervical neuromuscular control were derived. To assess the differences between groups in response to treatment, a random-intercept linear mixed-models analysis, applying a diagonal covariance matrix, was used.
RESULTS


A significant treatment × time interaction effect was found for neuromuscular control of the deep cervical flexors, favoring the experimental treatment at 3 months' follow-up (mean group difference: 1.982; 95% confidence interval 0.779, 3.185; large effect size d = 0.82). Significant main effects of time were found for the neuromuscular capacity of scapulothoracic muscles and for cervical mobility. No significant effects were found for balance, cervical muscle strength, or endurance of cervical flexors.
CONCLUSION


Pain neuroscience education combined with cognition-targeted motor control training is not more effective than biomedically focused education and exercise therapy for improving cervical motor output in people with chronic neck pain. Our findings question the relative importance of factors such as pain, disability, and maladaptive pain cognitions on cervical motor output and the need to address it in treatment.",2020,"A significant treatment x time interaction effect was found for neuromuscular control of the deep cervical flexors, favoring the experimental treatment at 3 months follow-up (mean group difference: 1.982; 95% CI 0.779,3.185; large effect size D =.82).","['people with chronic neck pain', '64 subjects with chronic neck pain using standardized tests']","['cognition-targeted motor control training', 'exercise therapy', 'pain neuroscience education plus cognition-targeted motor control training']","['balance, cervical muscle strength and endurance of cervical flexors', 'neuromuscular control of the deep cervical flexors', 'neuromuscular capacity of scapulothoracic muscles and for cervical mobility', 'Cervical muscle strength, cervical mobility, balance and cervical neuromuscular control']","[{'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}]",64.0,0.175545,"A significant treatment x time interaction effect was found for neuromuscular control of the deep cervical flexors, favoring the experimental treatment at 3 months follow-up (mean group difference: 1.982; 95% CI 0.779,3.185; large effect size D =.82).","[{'ForeName': 'Ward', 'Initials': 'W', 'LastName': 'Willaert', 'Affiliation': 'Department of Physiotherapy, Human Physiology and Anatomy (KIMA), Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussel, Belgium.'}, {'ForeName': 'Anneleen', 'Initials': 'A', 'LastName': 'Malfliet', 'Affiliation': 'Department of Physiotherapy, Human Physiology and Anatomy (KIMA), Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussel, Belgium.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Coppieters', 'Affiliation': 'Department of Physiotherapy, Human Physiology and Anatomy (KIMA), Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussel, Belgium.'}, {'ForeName': 'Dorine', 'Initials': 'D', 'LastName': 'Lenoir', 'Affiliation': 'Department of Physiotherapy, Human Physiology and Anatomy (KIMA), Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussel, Belgium.'}, {'ForeName': 'Robby', 'Initials': 'R', 'LastName': 'De Pauw', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Lieven', 'Initials': 'L', 'LastName': 'Danneels', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Roussel', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy (MOVANT), Faculty of Medicine and Health Sciences, University of Antwerp, Wilrijk, Belgium.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Meeus', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Cagnie', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Nijs', 'Affiliation': 'Department of Physiotherapy, Human Physiology and Anatomy (KIMA), Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussel, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Kregel', 'Affiliation': 'Department of Physiotherapy, Human Physiology and Anatomy (KIMA), Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussel, Belgium.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12884']
186,31421635,Maintenance of antidepressant and antisuicidal effects by D-cycloserine among patients with treatment-resistant depression who responded to low-dose ketamine infusion: a double-blind randomized placebo-control study.,"Increasing evidence supports a rapid antidepressant and antisuicidal effect of a single subanesthetic dose of ketamine infusion for treatment-resistant depression (TRD). Maintaining the initial clinical response after ketamine infusion in TRD is a crucial next-step challenge. D-cycloserine (DCS), a partial agonist of the glycine co-agonist of the N-methyl-D-aspartate (NMDA) glutamate receptor, is potentially effective as a depression augmentation treatment. However, whether DCS maintains the antidepressant and antisuicidal effects of ketamine infusion remains unknown. In all, 32 patients with TRD (17 with major depression and 15 with bipolar depression) who responded to ketamine infusion with an average 17-item Hamilton Depression Rating Scale (HAMD) score of 9.47 ± 4.11 at baseline were randomly divided to 6-week DCS treatment (250 mg for 2 days, 500 mg for 2 days, 750 mg for 3 days, and 1000 mg for 5 weeks) and placebo groups. Depression symptoms were rated at timepoints of dose titration and weekly. During the 6-week treatment, the total scores of HAMD did not differ between the DCS and placebo groups. The results remained consistent when stratified by disorder. A mixed model analysis indicated that the DCS group exhibited lower scores of HAMD item 3 (suicide) compared with the placebo group throughout the follow-up period (p = 0.01). A superior maintenance of the antisuicidal effect of ketamine was observed in the DCS group than in the placebo group. DCS may be therapeutically beneficial for patients with TRD who responded to ketamine infusion but have a residual suicidal risk.",2019,A superior maintenance of the antisuicidal effect of ketamine was observed in the DCS group than in the placebo group.,"['32 patients with TRD (17 with major depression and 15 with bipolar depression', 'infusion with an average 17-item Hamilton Depression Rating Scale (HAMD) score of 9.47\u2009±\u20094.11 at baseline', 'patients with treatment-resistant depression who responded to low-dose ketamine infusion', 'patients with TRD']","['DCS treatment', 'placebo', 'DCS', 'ketamine', 'D-cycloserine (DCS', 'D-cycloserine']","['total scores of HAMD', 'Depression symptoms', 'HAMD item 3 (suicide']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}]",,0.143272,A superior maintenance of the antisuicidal effect of ketamine was observed in the DCS group than in the placebo group.,"[{'ForeName': 'Mu-Hong', 'Initials': 'MH', 'LastName': 'Chen', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Ming', 'Initials': 'CM', 'LastName': 'Cheng', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Wei-Chen', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Cheng-Ta', 'Initials': 'CT', 'LastName': 'Li', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chen-Jee', 'Initials': 'CJ', 'LastName': 'Hong', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Pei-Chi', 'Initials': 'PC', 'LastName': 'Tu', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ya-Mei', 'Initials': 'YM', 'LastName': 'Bai', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Jen', 'Initials': 'SJ', 'LastName': 'Tsai', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA. john.krystal@yale.edu.'}, {'ForeName': 'Tung-Ping', 'Initials': 'TP', 'LastName': 'Su', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan. tomsu0402@gmail.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0480-y']
187,30074812,"The Role of Rape-Supportive Attitudes, Alcohol, and Sexual Arousal in Sexual (Mis)Perception: An Experimental Study.","While sexual misperception does not irrevocably lead to sexual aggression, it remains a significant risk factor. The present study investigated the effects of rape-supportive attitudes, alcohol, and sexual arousal on sexual perception. We used a 2 × 2 between-participants factorial design to randomly assign 135 men from the general population to a condition with or without alcohol (blood alcohol concentration target of .08%) and to a condition with or without sexual arousal. Participants were asked to listen to an audiotape depicting a sexual interaction between a man and woman and to indicate if and when they believed the woman was no longer interested in having sex. Results, obtained through survival analyses, indicate that the effects of rape-supportive attitudes on sexual misperception are moderated by alcohol consumption. Alcohol appears to be an important situational factor for activating men's implicit theories. Our study sheds new light on the role of knowledge structures in sexual perception: It identifies when, as well as suggesting how, rape-supportive attitudes may disturb sexual perception and ultimately lead to sexual misperception.",2019,"Results, obtained through survival analyses, indicate that the effects of rape-supportive attitudes on sexual misperception are moderated by alcohol consumption.","['2\xa0×\xa02 between-participants factorial design to randomly assign 135 men from the general population to a condition with or without alcohol (blood alcohol concentration target of .08%) and to a condition with or without sexual arousal', 'sexual perception']",['Mis)Perception'],[],"[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0684262', 'cui_str': 'Blood Alcohol Level'}, {'cui': 'C0233972', 'cui_str': 'Sexual excitation, function (observable entity)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",[],[],135.0,0.0104832,"Results, obtained through survival analyses, indicate that the effects of rape-supportive attitudes on sexual misperception are moderated by alcohol consumption.","[{'ForeName': 'Massil', 'Initials': 'M', 'LastName': 'Benbouriche', 'Affiliation': 'a School of Criminology, University of Montreal.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Testé', 'Affiliation': 'b Department of Psychology , University of Rennes 2.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Guay', 'Affiliation': 'a School of Criminology, University of Montreal.'}, {'ForeName': 'Marc E', 'Initials': 'ME', 'LastName': 'Lavoie', 'Affiliation': 'c Department of Psychiatry , University of Montreal.'}]",Journal of sex research,['10.1080/00224499.2018.1496221']
188,32307878,Changes in blood parameters after intramuscular testosterone ester injections - Implications for anti-doping.,"Testosterone treatment stimulates the production of red blood cells and alters iron homeostasis. Thus, we investigated whether the 'haematological module' of the athlete biological passport (ABP) used by the World Anti-Doping Agency can be used to indicate misuse of testosterone. Nineteen eugonadal men received intramuscular injections of either 250 mg Sustanon®, a blend of four testosterone esters, or placebo on days 0 and 21 in a randomized, placebo-controlleddouble-blind design. Urine samples and blood samples were collected twice pre-treatment, at least 5 days apart, and on days 1, 3, 5, 10 and 14 post-injections to assess steroidal and haematological biomarkers of the ABP. The steroidal profile was flagged suspicious in all Sustanon®-treated subjects, whereas the haematological profile was flagged suspicious in six out of nine subjects. When both sensitivity and specificity were considered, reticulocyte percentage (RET%) appeared as the best marker of the haematological module for implying testosterone ester misuse. Atypical blood passport samples were used to select time points for further isotope-ratio mass spectrometry (IRMS) analysis of testosterone and its metabolites in simultaneously collected urine. In addition to the testosterone (T) to epitestosterone (E) ratio, the RET% and OFF-Score could help identify suspicious samples for more targeted IRMS testing. The results demonstrate that unexpected fluctuations in RET% can indicate testosterone doping if samples are collected 3-10 days after injection. From an anti-doping perspective, the haematological and steroidal modules of the ABP should complement each other when planning targeted follow-up testing and substantiating likely misuse of testosterone.",2020,"When considering both sensitivity and specificity, RET% appeared as the best marker of the hematological module for implying testosterone ester misuse.",['Nineteen eugonadal men'],"['Athlete Biological Passport (ABP) used by the World Anti-Doping Agency (WADA', 'intramuscular injections of either 250 mg Sustanon®, a blend of four testosterone esters, or placebo', 'Testosterone', 'placebo']","['blood parameters', 'red blood cell production and alters iron homeostasis']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C1273517', 'cui_str': 'Used by'}, {'cui': 'C0013039', 'cui_str': 'Doping in Sports'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0075665', 'cui_str': 'Sustanon'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0014898', 'cui_str': 'Ester'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}]",9.0,0.0740844,"When considering both sensitivity and specificity, RET% appeared as the best marker of the hematological module for implying testosterone ester misuse.","[{'ForeName': 'Sara Amalie', 'Initials': 'SA', 'LastName': 'Solheim', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Mørkeberg', 'Affiliation': 'Anti Doping Denmark, Brøndby, Denmark.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Dehnes', 'Affiliation': 'Norwegian Doping Control Laboratory, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ingunn', 'Initials': 'I', 'LastName': 'Hullstein', 'Affiliation': 'Norwegian Doping Control Laboratory, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Juul', 'Affiliation': 'Department of Growth and Reproduction, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Emmie N', 'Initials': 'EN', 'LastName': 'Upners', 'Affiliation': 'Department of Growth and Reproduction, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nikolai Baastrup', 'Initials': 'NB', 'LastName': 'Nordsborg', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}]",Drug testing and analysis,['10.1002/dta.2803']
189,31443102,Colonization by B. infantis EVC001 modulates enteric inflammation in exclusively breastfed infants.,"BACKGROUND


Infant gut dysbiosis, often associated with low abundance of bifidobacteria, is linked to impaired immune development and inflammation-a risk factor for increased incidence of several childhood diseases. We investigated the impact of B. infantis EVC001 colonization on enteric inflammation in a subset of exclusively breastfed term infants from a larger clinical study.
METHODS


Stool samples (n = 120) were collected from infants randomly selected to receive either 1.8 × 10 10  CFU B. infantis EVC001 daily for 21 days (EVC001) or breast milk alone (controls), starting at day 7 postnatal. The fecal microbiome was analyzed using 16S ribosomal RNA, proinflammatory cytokines using multiplexed immunoassay, and fecal calprotectin using ELISA at three time points: days 6 (Baseline), 40, and 60 postnatal.
RESULTS


Fecal calprotectin concentration negatively correlated with Bifidobacterium abundance (P < 0.0001; ρ = -0.72), and proinflammatory cytokines correlated with Clostridiaceae and Enterobacteriaceae, yet negatively correlated with Bifidobacteriaceae abundance. Proinflammatory cytokines were significantly lower in EVC001-fed infants on days 40 and 60 postnatally compared to baseline and compared to control infants.
CONCLUSION


Our findings indicate that gut dysbiosis (absence of B. infantis) is associated with increased intestinal inflammation. Early addition of EVC001 to diet represents a novel strategy to prevent enteric inflammation during a critical developmental phase.",2019,"Proinflammatory cytokines were significantly lower in EVC001-fed infants on days 40 and 60 postnatally compared to baseline and compared to control infants.
","['exclusively breastfed infants', 'Stool samples (n\u2009=\u2009120']","['CFU B. infantis EVC001 daily for 21 days (EVC001) or breast milk alone (controls), starting at day 7 postnatal']","['Proinflammatory cytokines', 'intestinal inflammation', 'fecal microbiome', 'Fecal calprotectin concentration', 'enteric inflammation', 'proinflammatory cytokines']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1550661', 'cui_str': 'Feces specimen'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}]","[{'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C3889047', 'cui_str': 'Intestinal inflammation'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",1010.0,0.0603489,"Proinflammatory cytokines were significantly lower in EVC001-fed infants on days 40 and 60 postnatally compared to baseline and compared to control infants.
","[{'ForeName': 'Bethany M', 'Initials': 'BM', 'LastName': 'Henrick', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA. bhenrick2@unl.edu.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Chew', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Casaburi', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'Heather K', 'Initials': 'HK', 'LastName': 'Brown', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Frese', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Morrison Microscopy Core Research Facility, University of Nebraska, Lincoln, NE, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Underwood', 'Affiliation': 'Foods for Health Institute, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Jennifer T', 'Initials': 'JT', 'LastName': 'Smilowitz', 'Affiliation': 'Foods for Health Institute, University of California Davis, Davis, CA, USA.'}]",Pediatric research,['10.1038/s41390-019-0533-2']
190,31055726,End-expiratory lung volume decreases during REM sleep despite continuous positive airway pressure.,"PURPOSE


Patients with obstructive sleep apnea (OSA) may experience apneas and hypopneas primarily during stage R (REM) sleep when end-expiratory lung volume (EELV) reaches its nadir. The purpose of this study was to determine if REM-related reductions in EELV persist in the presence of continuous positive airway pressure (CPAP) prescribed during non-stage REM (NREM) sleep.
METHODS


We prospectively recruited 17 subjects referred to the sleep laboratory for CPAP titration. CPAP was titrated per AASM protocol to control respiratory events. The change in EELV was measured using magnetometry.
RESULTS


Of the 17 subjects, 12 (71%) had moderate to severe OSA. Despite the application of CPAP, there was a significant reduction in EELV between NREM and REM sleep (- 105.9 ± 92.2 to - 325.0 ± 113.1 mL, respectively, p < 0.01). The change in EELV between non-stage R (NREM) and REM significantly correlated with overall apnea-hypopnea index (AHI) (r = 0.5, p = 0.04), the number of respiratory arousals during REM (r = 0.5, p = 0.04), and prescribed level of CPAP (r = 0.7, p < 0.01).
CONCLUSION


REM-related reductions in EELV are associated with worsening sleep disordered breathing and occur despite the presence of CPAP.",2020,"The change in EELV between non-stage R (NREM) and REM significantly correlated with overall apnea-hypopnea index (AHI) (r = 0.5, p = 0.04), the number of respiratory arousals during REM (r = 0.5, p = 0.04), and prescribed level of CPAP (r = 0.7, p < 0.01).
","['17 subjects referred to the sleep laboratory for CPAP titration', 'Patients with obstructive sleep apnea (OSA']",['CPAP'],"['EELV between NREM and REM sleep', 'prescribed level of CPAP', 'change in EELV', 'moderate to severe OSA', 'overall apnea-hypopnea index (AHI', 'number of respiratory arousals']","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0037322', 'cui_str': 'Sleep, Fast-Wave'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}]",17.0,0.0298988,"The change in EELV between non-stage R (NREM) and REM significantly correlated with overall apnea-hypopnea index (AHI) (r = 0.5, p = 0.04), the number of respiratory arousals during REM (r = 0.5, p = 0.04), and prescribed level of CPAP (r = 0.7, p < 0.01).
","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Koo', 'Affiliation': 'Baroness Erlanger Hospital, Respiratory, Critical Care, and Sleep Medicine, University of Tennessee College of Medicine Chattanooga, 975 E 3rd Street, C-735, Chattanooga, TN, 37403, USA. drpkoo@gmail.com.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Gartman', 'Affiliation': 'Providence VA Medical Center, Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Jigme M', 'Initials': 'JM', 'LastName': 'Sethi', 'Affiliation': 'Baroness Erlanger Hospital, Respiratory, Critical Care, and Sleep Medicine, University of Tennessee College of Medicine Chattanooga, 975 E 3rd Street, C-735, Chattanooga, TN, 37403, USA.'}, {'ForeName': 'F Dennis', 'Initials': 'FD', 'LastName': 'McCool', 'Affiliation': 'Rhode Island Hospital, Alpert Medical School of Brown University, Providence, RI, USA.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-019-01857-9']
191,30371767,Timing of revascularization in patients with transient ST-segment elevation myocardial infarction: a randomized clinical trial.,"Aims


Patients with acute coronary syndrome who present initially with ST-elevation on the electrocardiogram but, subsequently, show complete normalization of the ST-segment and relief of symptoms before reperfusion therapy are referred to as transient ST-segment elevation myocardial infarction (STEMI) and pose a therapeutic challenge. It is unclear what the optimal timing of revascularization is for these patients and whether they should be treated with a STEMI-like or a non-ST-segment elevation myocardial infarction (NSTEMI)-like invasive approach. The aim of the study is to determine the effect of an immediate vs. a delayed invasive strategy on infarct size measured by cardiac magnetic resonance imaging (CMR).
Methods and results


In a randomized clinical trial, 142 patients with transient STEMI with symptoms of any duration were randomized to an immediate (STEMI-like) [0.3 h; interquartile range (IQR) 0.2-0.7 h] or a delayed (NSTEMI-like) invasive strategy (22.7 h; IQR 18.2-27.3 h). Infarct size as percentage of the left ventricular myocardial mass measured by CMR at day four was generally small and not different between the immediate and the delayed invasive group (1.3%; IQR 0.0-3.5% vs. 1.5% IQR 0.0-4.1%, P = 0.48). By intention to treat, there was no difference in major adverse cardiac events (MACE), defined as death, reinfarction, or target vessel revascularization at 30 days (2.9% vs. 2.8%, P = 1.00). However, four additional patients (5.6%) in the delayed invasive strategy required urgent intervention due to signs and symptoms of reinfarction while awaiting angiography.
Conclusion


Overall, infarct size in transient STEMI is small and is not influenced by an immediate or delayed invasive strategy. In addition, short-term MACE was low and not different between the treatment groups.",2019,"By intention to treat, there was no difference in major adverse cardiac events (MACE), defined as death, reinfarction, or target vessel revascularization at 30 days (2.9% vs. 2.8%, P = 1.00).","['Patients with acute coronary syndrome who present initially with ST-elevation on the electrocardiogram but, subsequently, show complete normalization of the ST-segment and relief of symptoms before reperfusion therapy are referred to as transient ST-segment elevation myocardial infarction (STEMI) and pose a therapeutic challenge', '142 patients with transient STEMI with symptoms of any duration', 'patients with transient ST-segment elevation myocardial infarction']",['cardiac magnetic resonance imaging (CMR'],"['Infarct size as percentage of the left ventricular myocardial mass', 'major adverse cardiac events (MACE), defined as death, reinfarction, or target vessel revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation (finding)'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0429029', 'cui_str': 'ST segment (observable entity)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",142.0,0.199712,"By intention to treat, there was no difference in major adverse cardiac events (MACE), defined as death, reinfarction, or target vessel revascularization at 30 days (2.9% vs. 2.8%, P = 1.00).","[{'ForeName': 'Jorrit S', 'Initials': 'JS', 'LastName': 'Lemkes', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, VU University Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.'}, {'ForeName': 'Gladys N', 'Initials': 'GN', 'LastName': 'Janssens', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, VU University Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.'}, {'ForeName': 'Nina W', 'Initials': 'NW', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, VU University Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Biostatistics, VU University, De Boelelaan 1089a, Amsterdam, the Netherlands.'}, {'ForeName': 'Koen M J', 'Initials': 'KMJ', 'LastName': 'Marques', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, VU University Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Nap', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, VU University Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.'}, {'ForeName': 'Maarten A H', 'Initials': 'MAH', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, VU University Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.'}, {'ForeName': 'Yolande E A', 'Initials': 'YEA', 'LastName': 'Appelman', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, VU University Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Knaapen', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, VU University Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.'}, {'ForeName': 'Niels J W', 'Initials': 'NJW', 'LastName': 'Verouden', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, VU University Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.'}, {'ForeName': 'Cornelis P', 'Initials': 'CP', 'LastName': 'Allaart', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, VU University Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.'}, {'ForeName': 'Stijn L', 'Initials': 'SL', 'LastName': 'Brinckman', 'Affiliation': 'Department of Cardiology, Tergooi Hospital, Rijksstraatweg 1, Blaricum, the Netherlands.'}, {'ForeName': 'Colette E', 'Initials': 'CE', 'LastName': 'Saraber', 'Affiliation': 'Department of Cardiology, Tergooi Hospital, Rijksstraatweg 1, Blaricum, the Netherlands.'}, {'ForeName': 'Koos J', 'Initials': 'KJ', 'LastName': 'Plomp', 'Affiliation': 'Department of Cardiology, Tergooi Hospital, Rijksstraatweg 1, Blaricum, the Netherlands.'}, {'ForeName': 'Jorik R', 'Initials': 'JR', 'LastName': 'Timmer', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Dokter van Heesweg 2, Zwolle, the Netherlands.'}, {'ForeName': 'Elvin', 'Initials': 'E', 'LastName': 'Kedhi', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Dokter van Heesweg 2, Zwolle, the Netherlands.'}, {'ForeName': 'Renicus S', 'Initials': 'RS', 'LastName': 'Hermanides', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Dokter van Heesweg 2, Zwolle, the Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Meuwissen', 'Affiliation': 'Department of Cardiology, Amphia Hospital, Molengracht 21, Breda, the Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Schaap', 'Affiliation': 'Department of Cardiology, Amphia Hospital, Molengracht 21, Breda, the Netherlands.'}, {'ForeName': 'Arno P', 'Initials': 'AP', 'LastName': 'van der Weerdt', 'Affiliation': 'Department of Cardiology, Medical Center Leeuwarden, Henri Dunantweg 2, Leeuwarden, the Netherlands.'}, {'ForeName': 'Albert C', 'Initials': 'AC', 'LastName': 'van Rossum', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, VU University Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Nijveldt', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, VU University Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, VU University Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.'}]",European heart journal,['10.1093/eurheartj/ehy651']
192,32247654,Video game-based therapy for the non-dominant hand improves manual skills and grip strength.,"The study was designed to investigate the effect of virtual reality-supported training on manual skills and grip strength in the non-dominant hand in healthy participants. Thirty participants were randomized into two groups: ErgoActive group (n=15) and control group (n=15). The ErgoActive study group received 8 weeks of training with leap motion controller-based virtual reality games. The training was done 1 day per week for 30min. The participants' hand function was evaluated using the Jebsen Taylor Hand Function Test (JTHFT), while grip strength was evaluated with a Jamar Hand Dynamometer and Pinchmeter. After 8 weeks, the ErgoActive and control groups had significantly different JTHFT, Jamar and Pinchmeter results (P<0.05). When leap motion controller-based virtual reality applications are used, healthy subjects have increased manual skills and grip strength in their non-dominant hand. These virtual reality games are an effective and fun way of improving patients' hand functions.",2020,"After 8 weeks, the ErgoActive and control groups had significantly different JTHFT, Jamar and Pinchmeter results (p < 0.05).","['healthy subjects', 'healthy participants', 'Thirty participants']","['training with Leap Motion Controller-based virtual reality games', 'virtual reality-supported training', 'ErgoActive group (n\u2009=\u200915) and control group', 'Video game-based therapy']","['manual skills and grip strength', 'Jebsen Taylor Hand Function Test (JTHFT), while grip strength']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0040608', 'cui_str': 'Training Support'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",30.0,0.0156678,"After 8 weeks, the ErgoActive and control groups had significantly different JTHFT, Jamar and Pinchmeter results (p < 0.05).","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bostanci', 'Affiliation': 'Division of Ergotherapy, Faculty of Health Sciences, Istanbul Medipol University, Kavacik, Ekinciler Cd. No: 19, 34810 Istanbul, Beykoz, Turkey. Electronic address: hbostanci@medipol.edu.tr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Emir', 'Affiliation': 'Division of Ergotherapy, Faculty of Health Sciences, Istanbul Medipol University, Kavacik, Ekinciler Cd. No: 19, 34810 Istanbul, Beykoz, Turkey.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tarakci', 'Affiliation': 'Division of Ergotherapy, Faculty of Health Sciences, Istanbul Medipol University, Kavacik, Ekinciler Cd. No: 19, 34810 Istanbul, Beykoz, Turkey.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Tarakci', 'Affiliation': 'Division of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul University-Cerrahpasa, Zuhuratbaba, Doktor Tevfik Sağlam Cd. No. 25, 34147 Istanbul, Bakirköy, Turkey.'}]",Hand surgery & rehabilitation,['10.1016/j.hansur.2020.02.011']
193,31115739,The effects of threshold inspiratory muscle training in patients with obstructive sleep apnea: a randomized experimental study.,"OBJECTIVES


Patients with obstructive sleep apnea (OSA) (an obstructed airway and intermittent hypoxia) negatively affect their respiratory muscles. We evaluated the effects of a 12-week threshold inspiratory muscle training (TIMT) program on OSA severity, daytime sleepiness, and pulmonary function in newly diagnosed OSA.
METHODS


Sixteen patients with moderate-to-severe OSA were randomly assigned to a TIMT group and 6 to a control group. The home-based TIMT program was 30-45 min/day, 5 days/week, for 12 weeks using a TIMT training device. Their apnea-hypopnea index (AHI), Epworth sleepiness scale (ESS), and forced vital capacity (FVC) scores were evaluated pre- and post-treatment. Polysomnographic (PSG) analysis showed that 9 TIMT-group patients had positively responded (TIMT-responder group: post-treatment AHI < pre-treatment) and that 7 had not (TIMT non-responder group: post-treatment AHI > pre-treatment).
RESULTS


Post-treatment AHI and ESS scores were significantly (both P < 0.05) lower 6% and 20.2%, respectively. A baseline AHI ≤ 29.0/h predicted TIMT-responder group patients (sensitivity 77.8%; specificity 85.7%). FVC was also significantly (P < 0.05) higher 7.2%. Baseline AHI and FEV 6.0  were significant predictors of successful TIMT-responder group intervention. OSA severity and daytime sleepiness were also significantly attenuated.
CONCLUSIONS


Home-based TIMT training is simple, efficacious, and cost-effective.",2020,"RESULTS


Post-treatment AHI and ESS scores were significantly (both P < 0.05) lower 6% and 20.2%, respectively.","['Sixteen patients with moderate-to-severe OSA', 'patients with obstructive sleep apnea', 'Patients with obstructive sleep apnea (OSA']","['TIMT training', 'TIMT training device', 'threshold inspiratory muscle training (TIMT) program', 'TIMT', 'threshold inspiratory muscle training']","['apnea-hypopnea index (AHI), Epworth sleepiness scale (ESS), and forced vital capacity (FVC) scores', 'OSA severity and daytime sleepiness', 'FVC', 'Polysomnographic (PSG) analysis', 'ESS scores', 'OSA severity, daytime sleepiness, and pulmonary function']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]",16.0,0.0105972,"RESULTS


Post-treatment AHI and ESS scores were significantly (both P < 0.05) lower 6% and 20.2%, respectively.","[{'ForeName': 'Huei-Chen', 'Initials': 'HC', 'LastName': 'Lin', 'Affiliation': 'Institute of Allied Health Sciences, College of Medicine, National Cheng Kung University, No.1, Daxue Rd., East Dist., Tainan City, 70101, Taiwan.'}, {'ForeName': 'Ling-Ling', 'Initials': 'LL', 'LastName': 'Chiang', 'Affiliation': 'School of Respiratory Therapy, Taipei Medical University, No. 250 Wuxing St., Taipei, 11031, Taiwan.'}, {'ForeName': 'Jun-Hui', 'Initials': 'JH', 'LastName': 'Ong', 'Affiliation': 'Department of Physical Therapy, College of Medicine, National Cheng Kung University, No.1, Daxue Rd., East Dist., Tainan City, 70101, Taiwan.'}, {'ForeName': 'Kun-Ling', 'Initials': 'KL', 'LastName': 'Tsai', 'Affiliation': 'Department of Physical Therapy, College of Medicine, National Cheng Kung University, No.1, Daxue Rd., East Dist., Tainan City, 70101, Taiwan.'}, {'ForeName': 'Ching-Hsia', 'Initials': 'CH', 'LastName': 'Hung', 'Affiliation': 'Institute of Allied Health Sciences, College of Medicine, National Cheng Kung University, No.1, Daxue Rd., East Dist., Tainan City, 70101, Taiwan.'}, {'ForeName': 'Cheng-Yu', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Department of Otolaryngology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, No.138, Shengli Rd., North Dist., Tainan City, 70403, Taiwan. yu621109@ms48.hinet.net.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-019-01862-y']
194,31274231,Final analysis of a phase I/IIa trial of the folate-binding protein-derived E39 peptide vaccine to prevent recurrence in ovarian and endometrial cancer patients.,"BACKGROUND


E39, an HLA-A2-restricted, immunogenic peptide derived from the folate-binding protein (FBP), is overexpressed in multiple malignancies. We conducted a phase I/IIa trial of the E39 + GM-CSF vaccine with booster inoculations of either E39 or E39' (an attenuated version of E39) to prevent recurrences in disease-free endometrial and ovarian cancer patients(pts). Here, we present the final 24-month landmark analysis.
PATIENTS AND METHODS


HLA-A2 + patients receiving E39 + GM-CSF were included in the vaccine group (VG), and HLA-A2- pts (or HLA-A2 + patients refusing vaccine) were followed as the control group (CG). VG group received 6 monthly inoculations as the primary vaccine series (PVS) and were randomized to receive either E39 or E39' booster inoculations. Demographic, safety, immunologic, and disease-free survival (DFS) data were collected and evaluated.
RESULTS


Fifty-one patients were enrolled; 29 in the VG and 22 in the CG. Fourteen patients received <1000 μg and 15 received 1000 μg of E39. There were no clinicopathologic differences between VG and CG or between dose groups. E39 was well tolerated. At the 24 months landmark, DFS was 55.5% (VG) vs 40.0% (CG), P = 0.339. Patients receiving 1000 μg and boosted patients also showed improved DFS (P < 0.03). DFS was improved in the 1000 μg group after treatment of primary disease (90.0% vs CG:42.9%, P = 0.007), but not in recurrent patients. In low-FBP expressing patients, DFS was 100.0% (1000 μg), 50.0% (<1000 μg), and 25.0% (CG), P = 0.029.
CONCLUSIONS


This phase I/IIa trial reveals that E39 + GM-CSF is safe and may be effective in preventing recurrence in high-risk ovarian and endometrial cancer when optimally dosed (1000 μg) to FBP low patients being treated for primary disease.",2019,Patients receiving 1000 μg and boosted patients also showed improved DFS (P ,"['Fourteen patients received <1000\xa0μg and 15 received 1000\xa0μg of E39', 'disease-free endometrial and ovarian cancer patients(pts', 'HLA-A2\xa0+\xa0patients receiving E39\xa0+\xa0GM-CSF were included in the', 'Fifty-one patients were enrolled; 29 in the VG and 22 in the CG', 'ovarian and endometrial cancer patients']","['E39\xa0+\xa0GM-CSF', 'VG group received 6 monthly inoculations as the primary vaccine series (PVS', ""E39\xa0+\xa0GM-CSF vaccine with booster inoculations of either E39 or E39' (an attenuated version of E39"", 'vaccine group (VG), and HLA-A2- pts (or HLA-A2\xa0+\xa0patients refusing vaccine', ""E39 or E39' booster inoculations"", 'folate-binding protein-derived E39 peptide vaccine']","['DFS', 'Demographic, safety, immunologic, and disease-free survival (DFS) data', 'tolerated']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0115342', 'cui_str': 'E39'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0019733', 'cui_str': 'HLA-A2'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}]","[{'cui': 'C0115342', 'cui_str': 'E39'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}, {'cui': 'C1697762', 'cui_str': 'Booster'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0019733', 'cui_str': 'HLA-A2'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0242210', 'cui_str': 'Binding Proteins'}, {'cui': 'C0599934', 'cui_str': 'Vaccines, Peptide'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",51.0,0.100047,Patients receiving 1000 μg and boosted patients also showed improved DFS (P ,"[{'ForeName': 'Tommy A', 'Initials': 'TA', 'LastName': 'Brown', 'Affiliation': 'Department of Surgery, San Antonio Military Medical Center, San Antonio, Texas.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Byrd', 'Affiliation': 'National Capital Consortium Fellowship in Gynecologic Oncology, Walter Reed National Military Medical Center Bethesda, Bethesda, Maryland.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Vreeland', 'Affiliation': 'Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Guy T', 'Initials': 'GT', 'LastName': 'Clifton', 'Affiliation': 'Department of Surgery, San Antonio Military Medical Center, San Antonio, Texas.'}, {'ForeName': 'Doreen O', 'Initials': 'DO', 'LastName': 'Jackson', 'Affiliation': 'Department of Surgery, San Antonio Military Medical Center, San Antonio, Texas.'}, {'ForeName': 'Diane F', 'Initials': 'DF', 'LastName': 'Hale', 'Affiliation': 'Department of Surgery, San Antonio Military Medical Center, San Antonio, Texas.'}, {'ForeName': 'Garth S', 'Initials': 'GS', 'LastName': 'Herbert', 'Affiliation': 'Department of Surgery, San Antonio Military Medical Center, San Antonio, Texas.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Myers', 'Affiliation': 'Department of Surgery, San Antonio Military Medical Center, San Antonio, Texas.'}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Greene', 'Affiliation': 'Department of Surgery, San Antonio Military Medical Center, San Antonio, Texas.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Berry', 'Affiliation': 'Department of Surgery, Womack Army Medical Center, Fayetteville, North Carolina.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Cancer Vaccine Development Program, San Antonio, Texas.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Elkas', 'Affiliation': 'Department of Obstetrics and Gynecology, Inova Fairfax Hospital, Annandale, Virginia.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Conrads', 'Affiliation': 'National Capital Consortium Fellowship in Gynecologic Oncology, Walter Reed National Military Medical Center Bethesda, Bethesda, Maryland.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Darcy', 'Affiliation': 'National Capital Consortium Fellowship in Gynecologic Oncology, Walter Reed National Military Medical Center Bethesda, Bethesda, Maryland.'}, {'ForeName': 'Chad A', 'Initials': 'CA', 'LastName': 'Hamilton', 'Affiliation': 'National Capital Consortium Fellowship in Gynecologic Oncology, Walter Reed National Military Medical Center Bethesda, Bethesda, Maryland.'}, {'ForeName': 'George L', 'Initials': 'GL', 'LastName': 'Maxwel', 'Affiliation': 'National Capital Consortium Fellowship in Gynecologic Oncology, Walter Reed National Military Medical Center Bethesda, Bethesda, Maryland.'}, {'ForeName': 'George E', 'Initials': 'GE', 'LastName': 'Peoples', 'Affiliation': 'Department of Obstetrics and Gynecology, Inova Fairfax Hospital, Annandale, Virginia.'}]",Cancer medicine,['10.1002/cam4.2378']
195,31240541,APAP therapy does not improve impaired sleep quality and sympatho-vagal balance: a randomized trial in patients with obstructive sleep apnea and systolic heart failure.,"PURPOSE


In heart failure with reduced ejection fraction (HFrEF), the effects of automatic positive airway pressure therapy (APAP) for obstructive sleep apnea (OSA) on sleep quality and sympatho-vagal balance (SVB) are unknown.
METHODS


In this randomized controlled trial (6 months of APAP vs. nasal strips as control), sleep quality and SVB in patients with HFrEF and OSA were monitored. The distinction was made between different breathing conditions (5-min segments of OSA or normal breathing [NB] during stable N2 sleep) at baseline (T0), APAP initiation (T1), and 6 months of successful APAP treatment (T2).
RESULTS


Of 75 patients enrolled, 61 were men with average age of 65 ± 12 years and LVEF of 31 ± 9%; 37 patients were randomized into the APAP and 38 into the control (nasal strips only) group. At T0, OSA was associated with a 17% increase in the low-frequency/high-frequency component ratio of heart rate variability (LF/HF) versus baseline, suggesting an increase in sympathetic drive (SVB) with OSA compared with normal breathing. Respiratory indices and oxygen saturation all significantly improved at both T1 and T2, but at 6 months, APAP had no clinically relevant effect on objective sleep quality versus control. In fact, in patients with HFrEF (n = 23 with data suitable for HRV analysis), there was even a trend (p = 0.097) towards an additional 17% increase in LF/HF at T2 in the therapy group, suggesting (undesired) increased SVB in the APAP group.
CONCLUSION


Treatment of OSA in patients with systolic HF improves respiratory indices but does not have a favorable effect on sleep quality. While OSA per se was associated with an increase in sympathetic drive, APAP treatment was not associated with a reduction in sympathetic drive. After 6 months of treatment, there was even a trend towards additional increases in sympathetic drive in the APAP group.",2020,"At T0, OSA was associated with a 17% increase in the low-frequency/high-frequency component ratio of heart rate variability (LF/HF) versus baseline, suggesting an increase in sympathetic drive (SVB) with OSA compared with normal breathing.","['patients with obstructive sleep apnea and systolic heart failure', 'obstructive sleep apnea (OSA', 'patients with HFrEF and OSA', '75 patients enrolled, 61 were men with average age of 65\u2009±\u200912\xa0years and LVEF of 31\u2009±\u20099%; 37 patients']","['APAP', 'APAP therapy', 'APAP vs. nasal strips', 'OSA', 'automatic positive airway pressure therapy (APAP']","['sleep quality and SVB', 'sleep quality and sympatho-vagal balance', 'sympathetic drive', 'SVB', 'objective sleep quality', 'sleep quality', 'sleep quality and sympatho-vagal balance (SVB', 'LF/HF', 'Respiratory indices and oxygen saturation', 'sympathetic drive (SVB']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C1135191', 'cui_str': 'Heart Failure, Systolic'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C1321564', 'cui_str': 'Strip'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0451423', 'cui_str': 'Respiratory index (assessment scale)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}]",75.0,0.0360663,"At T0, OSA was associated with a 17% increase in the low-frequency/high-frequency component ratio of heart rate variability (LF/HF) versus baseline, suggesting an increase in sympathetic drive (SVB) with OSA compared with normal breathing.","[{'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Spiesshoefer', 'Affiliation': 'Respiratory Physiology Laboratory, Department of Neurology with Institute for Translational Neurology, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Aries', 'Affiliation': 'Respiratory Physiology Laboratory, Department of Neurology with Institute for Translational Neurology, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Giannoni', 'Affiliation': 'Cardiology and Cardiovascular Medicine Division, Fondazione Toscana Gabriele Monasterio, National Research Council, CNR-Regione Toscana, Pisa, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Emdin', 'Affiliation': 'Cardiology and Cardiovascular Medicine Division, Fondazione Toscana Gabriele Monasterio, National Research Council, CNR-Regione Toscana, Pisa, Italy.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Fox', 'Affiliation': 'Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Georgstraße 11, 32545, Bad Oeynhausen, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Boentert', 'Affiliation': 'Respiratory Physiology Laboratory, Department of Neurology with Institute for Translational Neurology, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bitter', 'Affiliation': 'Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Georgstraße 11, 32545, Bad Oeynhausen, Germany.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Oldenburg', 'Affiliation': 'Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Georgstraße 11, 32545, Bad Oeynhausen, Germany. akleemeyer@hdz-nrw.de.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-019-01868-6']
196,31197639,Effect of mean apnea-hypopnea duration in patients with obstructive sleep apnea on clinical and polysomnography parameter.,"OBJECTIVE


Apnea-hypopnea index is the number of apnea-hypopnea events observed during polysomnography within an hour. Mean apnea-hypopnea duration is the mean duration of all apneas and hypopneas. In this study, we aimed to investigate the association of mean apnea-hypopnea duration in patients with obstructive sleep apnea with clinical and polysomnographic parameters.
METHODS


In our hospital, a total of 764 patients were diagnosed with OSA by polysomnography in 2017. Age, body mass index, and the current diseases were recorded. Sleep structures obtained from polysomnography readings, blood oxygen levels, apnea-hypopnea index, and mean average duration were recorded. Patients with mean average duration of 20 s or more were assigned to the long average duration group and those with less than 20 s were assigned to the short average duration group. Groups were compared in terms of clinical and polysomnographic parameters.
RESULTS


Snoring, witnessed apnea, morning tiredness, and hypertension were significantly higher in the long average duration group. There was statistically significantly more male patients and higher neck circumference in the MAD group. Total wake duration, percentage of sleep, stage 3, stage 1, and mean oxygen saturation percentage of the long average duration group were significantly reduced.
CONCLUSION


In present study, the patients with obstructive sleep apnea with long average duration were found to have more negative effects of sleep apnea than the patients with short average duration. We think that the use of mean apnea-hypopnea duration as an indicator with apnea-hypopnea index will be beneficial for the follow-up and treatment of the disease.",2020,"RESULTS


Snoring, witnessed apnea, morning tiredness, and hypertension were significantly higher in the long average duration group.","['764 patients were diagnosed with OSA by polysomnography in 2017', 'patients with obstructive sleep apnea with clinical and polysomnographic parameters', 'patients with obstructive sleep apnea on clinical and polysomnography parameter', 'Patients with mean average duration of 20\xa0s or more were assigned to the long average duration group and those with less than 20\xa0s were assigned to the short average duration group', 'patients with obstructive sleep apnea with long average duration']",[],"['Snoring, witnessed apnea, morning tiredness, and hypertension', 'Total wake duration, percentage of sleep, stage 3, stage 1, and mean oxygen saturation percentage', 'Mean apnea-hypopnea duration', 'neck circumference', 'Sleep structures obtained from polysomnography readings, blood oxygen levels, apnea-hypopnea index, and mean average duration', 'sleep apnea', 'mean apnea-hypopnea duration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",[],"[{'cui': 'C0037384', 'cui_str': 'Snorings'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing (finding)'}, {'cui': 'C1630403', 'cui_str': 'Neck circumference'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}]",764.0,0.0140234,"RESULTS


Snoring, witnessed apnea, morning tiredness, and hypertension were significantly higher in the long average duration group.","[{'ForeName': 'Sema', 'Initials': 'S', 'LastName': 'Saraç', 'Affiliation': 'Department of Pulmonary Medicine, Sureyyapasa Teaching and Research Hospital, University of Medical Sciences Istanbul, Istanbul, Turkey. semasarac16@hotmail.com.'}, {'ForeName': 'Gulgun Cetintaş', 'Initials': 'GC', 'LastName': 'Afsar', 'Affiliation': 'Department of Pulmonary Medicine, Sureyyapasa Teaching and Research Hospital, University of Medical Sciences Istanbul, Istanbul, Turkey.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-019-01870-y']
197,32301407,"Effect of daily consumption of cranberry beverage on insulin sensitivity and modification of cardiovascular risk factors in adults with obesity: a pilot, randomised, placebo-controlled study.","Cranberries are high in polyphenols, and epidemiological studies have shown that a high-polyphenol diet may reduce risk factors for diabetes and CVD. The present study aimed to determine if short-term cranberry beverage consumption would improve insulin sensitivity and other cardiovascular risk factors. Thirty-five individuals with obesity and with elevated fasting glucose or impaired glucose tolerance participated in a randomised, double-blind, placebo-controlled, parallel-designed pilot trial. Participants consumed 450 ml of low-energy cranberry beverage or placebo daily for 8 weeks. Changes in insulin sensitivity and cardiovascular risk factors including vascular reactivity, blood pressure, RMR, glucose tolerance, lipid profiles and oxidative stress biomarkers were evaluated. Change in insulin sensitivity via hyperinsulinaemic-euglycaemic clamp was not different between the two groups. Levels of 8-isoprostane (biomarker of lipid peroxidation) decreased in the cranberry group but increased in the placebo group (-2·18 v. +20·81 pg/ml; P = 0·02). When stratified by baseline C-reactive protein (CRP) levels, participants with high CRP levels (>4 mg/l) benefited more from cranberry consumption. In this group, significant differences in the mean change from baseline between the cranberry (n 10) and the placebo groups (n 7) in levels of TAG (-13·75 v. +10·32 %; P = 0·04), nitrate (+3·26 v. -6·28 µmol/l; P = 0·02) and 8-isoprostane (+0·32 v. +30·8 pg/ml; P = 0·05) were observed. These findings indicate that 8 weeks of daily cranberry beverage consumption may not impact insulin sensitivity but may be helpful in lowering TAG and changing certain oxidative stress biomarkers in individuals with obesity and a proinflammatory state.",2020,"Levels of 8-isoprostane (biomarker of lipid peroxidation) decreased in the cranberry group but increased in the placebo group (-2.18 pg/mL vs +20.81 pg/mL, p=0.02).","['Thirty-five obese individuals with elevated fasting glucose or impaired glucose tolerance participated', 'Obese Adults', 'obese individuals with a proinflammatory state']","['low-calorie cranberry beverage or placebo', 'polyphenol diet', 'placebo', 'Daily Consumption of Cranberry Beverage', 'Placebo']","['Insulin Sensitivity and Modification of Cardiovascular Risk Factors', 'Levels of 8-isoprostane (biomarker of lipid peroxidation', 'insulin sensitivity via hyperinsulinemic euglycemic clamp', 'insulin sensitivity and cardiovascular risk factors including vascular reactivity, blood pressure, resting metabolic rate, glucose tolerance, lipid profiles, and oxidative stress biomarkers', 'insulin sensitivity and other cardiovascular risk factors', 'levels of triglyceride']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0295541', 'cui_str': '8-isoprostaglandin F2alpha'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023775', 'cui_str': 'Lipid peroxidation'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",,0.644559,"Levels of 8-isoprostane (biomarker of lipid peroxidation) decreased in the cranberry group but increased in the placebo group (-2.18 pg/mL vs +20.81 pg/mL, p=0.02).","[{'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Hsia', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA70808, USA.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Zhang', 'Affiliation': 'Ocean Spray Cranberries, Inc., Lakeville-Middleboro, MA02349, USA.'}, {'ForeName': 'Robbie S', 'Initials': 'RS', 'LastName': 'Beyl', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA70808, USA.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Greenway', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA70808, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Khoo', 'Affiliation': 'Ocean Spray Cranberries, Inc., Lakeville-Middleboro, MA02349, USA.'}]",The British journal of nutrition,['10.1017/S0007114520001336']
198,32293514,Addressing identification bias in the design and analysis of cluster-randomized pragmatic trials: a case study.,"BACKGROUND


Pragmatic trials provide the opportunity to study the effectiveness of health interventions to improve care in real-world settings. However, use of open-cohort designs with patients becoming eligible after randomization and reliance on electronic health records (EHRs) to identify participants may lead to a form of selection bias referred to as identification bias. This bias can occur when individuals identified as a result of the treatment group assignment are included in analyses.
METHODS


To demonstrate the importance of identification bias and how it can be addressed, we consider a motivating case study, the PRimary care Opioid Use Disorders treatment (PROUD) Trial. PROUD is an ongoing pragmatic, cluster-randomized implementation trial in six health systems to evaluate a program for increasing medication treatment of opioid use disorders (OUDs). A main study objective is to evaluate whether the PROUD intervention decreases acute care utilization among patients with OUD (effectiveness aim). Identification bias is a particular concern, because OUD is underdiagnosed in the EHR at baseline, and because the intervention is expected to increase OUD diagnosis among current patients and attract new patients with OUD to the intervention site. We propose a framework for addressing this source of bias in the statistical design and analysis.
RESULTS


The statistical design sought to balance the competing goals of fully capturing intervention effects and mitigating identification bias, while maximizing power. For the primary analysis of the effectiveness aim, identification bias was avoided by defining the study sample using pre-randomization data (pre-trial modeling demonstrated that the optimal approach was to use individuals with a prior OUD diagnosis). To expand generalizability of study findings, secondary analyses were planned that also included patients newly diagnosed post-randomization, with analytic methods to account for identification bias.
CONCLUSION


As more studies seek to leverage existing data sources, such as EHRs, to make clinical trials more affordable and generalizable and to apply novel open-cohort study designs, the potential for identification bias is likely to become increasingly common. This case study highlights how this bias can be addressed in the statistical study design and analysis.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03407638. Registered on 23 January 2018.",2020,"To demonstrate the importance of identification bias and how it can be addressed, we consider a motivating case study, the PRimary care Opioid Use Disorders treatment (PROUD) Trial.",['patients with OUD (effectiveness aim'],"['health interventions', 'PROUD intervention']",['OUD diagnosis'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",,0.080277,"To demonstrate the importance of identification bias and how it can be addressed, we consider a motivating case study, the PRimary care Opioid Use Disorders treatment (PROUD) Trial.","[{'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Bobb', 'Affiliation': 'Biostatistics Unit, Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Seattle, WA, 98101, USA. Jennifer.F.Bobb@kp.org.'}, {'ForeName': 'Hongxiang', 'Initials': 'H', 'LastName': 'Qiu', 'Affiliation': 'Department of Biostatistics, University of Washington, 1705 NE Pacific St, Seattle, WA, 98195, USA.'}, {'ForeName': 'Abigail G', 'Initials': 'AG', 'LastName': 'Matthews', 'Affiliation': 'The Emmes Company, 401 N Washington St # 700, Rockville, MD, 20850, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McCormack', 'Affiliation': 'The Emmes Company, 401 N Washington St # 700, Rockville, MD, 20850, USA.'}, {'ForeName': 'Katharine A', 'Initials': 'KA', 'LastName': 'Bradley', 'Affiliation': 'Biostatistics Unit, Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Seattle, WA, 98101, USA.'}]",Trials,['10.1186/s13063-020-4148-z']
199,32301812,The Influence of Speed During Stripping in Descemet Membrane Endothelial Keratoplasty Tissue Preparation.,"PURPOSE


To evaluate whether the speed of stripping a Descemet membrane endothelial keratoplasty graft influences the graft scroll width.
METHODS


Human corneas suitable for research were selected for the study. Pairs of corneas were randomly divided into 2 groups: 1 cornea was stripped with a slow speed (group 1) and the contralateral with a fast speed (group 2). Slow speed was defined as the total time greater than 150 seconds or speed <0.057 mm/s. Fast peeling was defined as less than 75 seconds or speed >0.11 mm/s. The grafts acquired were evaluated by microscopy for the graft scroll width and endothelial cell density change pre- and post-preparation.
RESULTS


Twenty corneas of 10 donors were included in the analysis. The mean donor age was 68.6 ± 7.58 years. The mean total time of the tissue preparation in group 1 was 282.7 ± 28 seconds and in group 2 was 126 ± 50 seconds (P-value = 0.00000047). The mean speed of stripping in group 1 was 0.045 ± 0.006 mm/s and in group 2 was 0.266 ± 0.093 mm/s (P-value = 0.000027). The graft width in group 1 was 6.4 ± 0.92 mm and in group 2 was 2.87 ± 0.32 mm (P-value = 0.00000014). The mean endothelial cell loss in group 1 was 389 ± 149 cells/mm and in group 2 was 186 ± 63.44 cells/mm (P-value = 0.00134).
CONCLUSION


We found a correlation between the speed of stripping, scroll width, and endothelial cell loss. Slow-peeled Descemet membrane endothelial keratoplasty grafts result in a wider scroll width but were associated with a greater reduction in endothelial cell density.",2020,The mean total time of the tissue preparation in group 1 was 282.7 ± 28 seconds and in group 2 was 126 ± 50 seconds (P-value = 0.00000047).,"['The mean donor age was 68.6 ± 7.58 years', 'Twenty corneas of 10 donors were included in the analysis', 'Human corneas suitable for research were selected for the study']","['Slow-peeled Descemet membrane endothelial keratoplasty grafts', '1 cornea was stripped with a slow speed (group 1) and the contralateral with a fast speed']","['speed of stripping, scroll width, and endothelial cell loss', 'graft width', 'mean speed of stripping', 'endothelial cell density', 'Fast peeling', 'Slow speed', 'mean endothelial cell loss', 'mean total time of the tissue preparation']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517855', 'cui_str': '68.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}, {'cui': 'C4302773', 'cui_str': ""Descemet's membrane endothelial keratoplasty""}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0200728', 'cui_str': 'Tissue processing technique'}]",,0.0244605,The mean total time of the tissue preparation in group 1 was 282.7 ± 28 seconds and in group 2 was 126 ± 50 seconds (P-value = 0.00000047).,"[{'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Borroni', 'Affiliation': ""Department of Corneal and External Eye Diseases, St Paul's Eye Unit, Royal Liverpool University Hospital, Liverpool, United Kingdom.""}, {'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Gadhvi', 'Affiliation': ""Department of Corneal and External Eye Diseases, St Paul's Eye Unit, Royal Liverpool University Hospital, Liverpool, United Kingdom.""}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Wojcik', 'Affiliation': 'International Center for Ocular Physiopathology, The Veneto Eye Bank Foundation, Venice, Italy.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Pennisi', 'Affiliation': 'Department of Ophthalmology, University Vita-Salute, IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Neeru A', 'Initials': 'NA', 'LastName': 'Vallabh', 'Affiliation': ""Department of Corneal and External Eye Diseases, St Paul's Eye Unit, Royal Liverpool University Hospital, Liverpool, United Kingdom.""}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Galeone', 'Affiliation': 'International Center for Ocular Physiopathology, The Veneto Eye Bank Foundation, Venice, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Ruzza', 'Affiliation': 'International Center for Ocular Physiopathology, The Veneto Eye Bank Foundation, Venice, Italy.'}, {'ForeName': 'Esmaeil', 'Initials': 'E', 'LastName': 'Arbabi', 'Affiliation': ""Department of Corneal and External Eye Diseases, St Paul's Eye Unit, Royal Liverpool University Hospital, Liverpool, United Kingdom.""}, {'ForeName': 'Nardine', 'Initials': 'N', 'LastName': 'Menassa', 'Affiliation': ""Department of Corneal and External Eye Diseases, St Paul's Eye Unit, Royal Liverpool University Hospital, Liverpool, United Kingdom.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Kaye', 'Affiliation': ""Department of Corneal and External Eye Diseases, St Paul's Eye Unit, Royal Liverpool University Hospital, Liverpool, United Kingdom.""}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Ponzin', 'Affiliation': 'International Center for Ocular Physiopathology, The Veneto Eye Bank Foundation, Venice, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ferrari', 'Affiliation': 'International Center for Ocular Physiopathology, The Veneto Eye Bank Foundation, Venice, Italy.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Romano', 'Affiliation': ""Department of Corneal and External Eye Diseases, St Paul's Eye Unit, Royal Liverpool University Hospital, Liverpool, United Kingdom.""}]",Cornea,['10.1097/ICO.0000000000002338']
200,32299820,Low-dose versus High-dose Carfilzomib with Dexamethasone (S1304) in Patients with Relapsed-Refractory Multiple Myeloma.,"PURPOSE


Treatment of multiple myeloma has evolved tremendously and optimal utilization of available therapies will ensure maximal patient benefits.
PATIENTS AND METHODS


We report the Southwest Oncology Group randomized phase II trial (S1304) comparing twice weekly low-dose (27 mg/m 2 ; arm 1) to high-dose carfilzomib (56 mg/m 2 ; arm 2), both with dexamethasone, administered for 12 cycles (11 months) for relapsed and/or refractory multiple myeloma with up to six prior lines of therapy (NCT01903811). The primary endpoint was progression-free survival (PFS), and patients on arm 1 could cross-over to arm 2 after progression on treatment.
RESULTS


Among 143 enrolled patients, of whom 121 were eligible and analyzable, the overall response rate was 42.8%, with no significant difference between the arms ( P  = 0.113). Also, neither the median PFS [5 months and 8 months, respectively; HR, 1.061; 80% Wald confidence interval (CI), 0.821-1.370;  P  = 0.384] nor the median overall survival were significantly different (26 and 22 months, respectively; HR, 1.149, 80% Wald CI, 0.841-.571;  P  = 0.284). Sixteen patients crossed over to arm 2 with a median PFS benefit of 3 months. Certain adverse events (AE) were more frequent in arm 2, including fatigue, thrombocytopenia, and peripheral neuropathy, but there was no significant difference in cardiopulmonary AEs.
CONCLUSIONS


This randomized trial did not support a benefit of fixed duration, twice weekly 56 mg/m 2  dosing of carfilzomib over the 27 mg/m 2  dose for the treatment of relapsed and/or refractory multiple myeloma. However, treatment to progression in earlier patient populations with high-dose carfilzomib using different schedules should still be considered as part of the standard of care.",2020,"Certain adverse events (AE) were more frequent in Arm 2, including fatigue, thrombocytopenia and peripheral neuropathy, but there was no significant difference in cardiopulmonary AEs.
","['multiple myeloma (MM', '143 enrolled patients', 'Patients with Relapsed-Refractory Multiple Myeloma']","['dexamethasone', 'carfilzomib', 'Dexamethasone']","['fatigue, thrombocytopenia and peripheral neuropathy', 'cardiopulmonary AEs', 'median overall survival', 'Certain adverse events (AE', 'overall response rate', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2001856', 'cui_str': 'carfilzomib'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",143.0,0.0870112,"Certain adverse events (AE) were more frequent in Arm 2, including fatigue, thrombocytopenia and peripheral neuropathy, but there was no significant difference in cardiopulmonary AEs.
","[{'ForeName': 'Sikander', 'Initials': 'S', 'LastName': 'Ailawadhi', 'Affiliation': 'Mayo Clinic, Jacksonville, Florida. ailawadhi.sikander@mayo.edu.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Sexton', 'Affiliation': 'Cancer Research and Biostatistics, Seattle, Washington.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Lentzsch', 'Affiliation': 'Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Muneer H', 'Initials': 'MH', 'LastName': 'Abidi', 'Affiliation': 'Spectrum Health/Michigan State University, Grand Rapids, Michigan.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Voorhees', 'Affiliation': 'Levine Cancer Institute, Charlotte, North Carolina.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Cohen', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Rohren', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Heitner', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Kelly', 'Affiliation': 'Norris Comprehensive Cancer Center, Los Angeles, California.'}, {'ForeName': 'Niklas J', 'Initials': 'NJ', 'LastName': 'Mackler', 'Affiliation': 'IHA Hem/Onc, Ann Arbor, Michigan.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Baer', 'Affiliation': 'Kaiser Permanente, Oakland, California.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Hoering', 'Affiliation': 'Cancer Research and Biostatistics, Seattle, Washington.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Durie', 'Affiliation': 'Cedars-Sinai Comprehensive Cancer Center, Los Angeles, California.'}, {'ForeName': 'Robert Z', 'Initials': 'RZ', 'LastName': 'Orlowski', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-1997']
201,32304590,Response to letter to the editor regarding article 'Randomised simulation trial found an association between rescuers' height and weight and chest compression quality during paediatric resuscitation'.,,2020,Thank you for giving us the opportunity to reply to Dr. Oh's letter about our recently published manuscript 'Randomised simulation trial found an association between rescuers' height and weight and chest compression quality during paediatric resuscitation'.,[],[],[],[],[],[],,0.0149721,Thank you for giving us the opportunity to reply to Dr. Oh's letter about our recently published manuscript 'Randomised simulation trial found an association between rescuers' height and weight and chest compression quality during paediatric resuscitation'.,"[{'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Bibl', 'Affiliation': 'Division of Neonatology, Pediatric Intensive Care and Neuropediatrics, Department of Pediatrics, Comprehensive Center for Pediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gröpel', 'Affiliation': 'Department of Applied Psychology: Work, Education and Economy, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Berger', 'Affiliation': 'Division of Neonatology, Pediatric Intensive Care and Neuropediatrics, Department of Pediatrics, Comprehensive Center for Pediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Georg M', 'Initials': 'GM', 'LastName': 'Schmölzer', 'Affiliation': 'Centre for the Studies of Asphyxia and Resuscitation, Neonatal Research Unit, Royal Alexandra Hospital, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Olischar', 'Affiliation': 'Division of Neonatology, Pediatric Intensive Care and Neuropediatrics, Department of Pediatrics, Comprehensive Center for Pediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wagner', 'Affiliation': 'Division of Neonatology, Pediatric Intensive Care and Neuropediatrics, Department of Pediatrics, Comprehensive Center for Pediatrics, Medical University of Vienna, Vienna, Austria.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15313']
202,31320735,Intravitreal dexamethasone implant as an alternative to systemic steroids as prophylaxis for uveitic cataract surgery: a randomized trial.,"PURPOSE


To determine the utility of the dexamethasone implant (IVD) as an alternative to systemic steroids as prophylaxis against cystoid macular edema (CMO) in patients with chronic, recurrent CMO associated intermediate or posterior uveitis (IU/PU), and cataract undergoing cataract surgery.
METHODS


This was a randomized, parallel design, and clinical trial. Patients with IU/PU and cataract scheduled for cataract surgery were randomly assigned to receive the IVD concurrently with cataract surgery (Group 1: 20 patients) or systemic steroids (Group 2: 23 patients) tapered over 4-6 weeks along with uneventful cataract surgery and routine postoperative care. Patients with glaucoma/contraindications to steroids were excluded. All patients were followed up for 6 months.
OUTCOME MEASURE


Primary-incidence of postoperative CMO. Secondary-the change in BCVA (corrected distance visual acuity) and Central Subfield thickness (CST) and complications. Appropriate statistical analysis was done.
RESULTS


The median age was 47.3 ± 4.23 years (group 1) and 49.12 ± 5.32 years (Group 2). One patient (Group 1) and two (Group 2) developed CMO. The BCVA improved significantly in both groups (p = 0.013). The CST change was insignificant. Four patients (Group 1) required intraocular pressure (IOP) lowering medications. Three patients (Group 2) required early steroid taper.
CONCLUSIONS


IVD is a good alternative as prophylaxis in IU/PU and cataract in preventing postoperative CMO.",2020,The BCVA improved significantly in both groups (p = 0.013).,"['uveitic cataract surgery', 'Patients with IU/PU and cataract scheduled for cataract surgery', 'The median age was 47.3\u2009±\u20094.23 years (group 1) and 49.12\u2009±\u20095.32 years (Group 2', 'Patients with glaucoma/contraindications to steroids were excluded', 'patients with chronic, recurrent CMO associated intermediate or posterior uveitis (IU/PU), and cataract undergoing cataract surgery']","['dexamethasone implant (IVD', 'IVD concurrently with cataract surgery', 'systemic steroids (Group 2: 23 patients) tapered over 4-6 weeks along with uneventful cataract surgery and routine postoperative care', 'Intravitreal dexamethasone implant']","['CMO', 'BCVA', 'postoperative CMO', 'BCVA (corrected distance visual acuity) and Central Subfield thickness (CST) and complications', 'intraocular pressure (IOP) lowering medications']","[{'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0042167', 'cui_str': 'Uveitis, Posterior'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0032786', 'cui_str': 'Postoperative Care'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}]",,0.0567074,The BCVA improved significantly in both groups (p = 0.013).,"[{'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Sudhalkar', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India. adityasudhalkar@yahoo.com.'}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Bhojwani', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Viraj', 'Initials': 'V', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Shail', 'Initials': 'S', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Samaresh', 'Initials': 'S', 'LastName': 'Srivastava', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}]","Eye (London, England)",['10.1038/s41433-019-0534-8']
203,32304676,"Impact of sugar taxes and front-of-package nutrition labels on purchases of protein, calcium and fibre.","Taxes and front-of-package (FOP) labels can be effective interventions for reducing consumption of sugar, saturated fat, and sodium; however, few studies have examined their impact on intake of 'positive' nutrients. The current study explored the impact of sugar taxes and FOP labels on the protein, calcium and fibre density of snack food purchases. A total of 3584 Canadians aged 13 years and older participated in an experimental marketplace using a 3 × 8 between-within group experiment. Participants received $5 and viewed images of 20 snack food products available for purchase. Participants were randomized to one of five FOP label conditions (no label, high in, multiple traffic light, health star rating, or nutrition grade) and completed three within-subject purchasing tasks with different sugar tax conditions (no tax, 20%, tiered). Upon conclusion, participants received the product and any change from one of the purchasing tasks. The results indicate that participants purchased snack foods with higher fibre density when either sugar tax was applied (+0.1 g/100 kcal) compared to no tax, and when they were assigned to see the multiple traffic light (+0.4 g/100 kcal) or health star rating (+0.3 g/100 kcal) FOP labels, compared to no FOP label. There were no significant differences in the protein or calcium density of snack foods purchased across the tax or FOP labelling conditions. Overall, the findings suggest that as consumers respond to tax or labelling policies by moving away from sugars, sodium, and saturated fat, there may be no downside-or even an increase-in 'positive' nutrient density.",2020,There were no significant differences in the protein or calcium density of snack foods purchased across the tax or FOP labelling conditions.,['3584 Canadians aged 13\u202fyears and older participated in an experimental marketplace using a 3\u202f×\u202f8 between-within group experiment'],"['sugar taxes and front-of-package nutrition labels', 'multiple traffic light (+0.4\u202fg/100\u202fkcal) or health star rating (+0.3\u202fg/100\u202fkcal) FOP labels', 'sugar taxes and FOP labels', 'Taxes and front-of-package (FOP) labels', 'FOP label conditions (no label, high in, multiple traffic light, health star rating, or nutrition grade) and completed three within-subject purchasing tasks with different sugar tax conditions (no tax, 20%, tiered']","['purchases of protein, calcium and fibre']","[{'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0039371', 'cui_str': 'Tax'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0028711', 'cui_str': 'Nutrition Labeling'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0442664', 'cui_str': 'Traffic light'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}]",3584.0,0.0287178,There were no significant differences in the protein or calcium density of snack foods purchased across the tax or FOP labelling conditions.,"[{'ForeName': 'Rachel B', 'Initials': 'RB', 'LastName': 'Acton', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, 200 University Ave W, Waterloo, ON N2L 3G1, Canada. Electronic address: rbacton@uwaterloo.ca.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hammond', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, 200 University Ave W, Waterloo, ON N2L 3G1, Canada. Electronic address: david.hammond@uwaterloo.ca.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106091']
204,32202035,A randomised trial of caesarean wound coverage: exposed versus dressed.,"OBJECTIVE


To evaluate the superficial surgical site infection (SSI) rate to 28 days and patient satisfaction with wound coverage management when their transverse suprapubic caesarean wound is left exposed compared with dressed after skin closure.
DESIGN


Randomised trial.
SETTING


University Hospital, Malaysia: April 2016-October 2016.
POPULATION


331 women delivered by caesarean section.
METHOD


Participants were randomised to leaving their wound entirely exposed (n = 165) or dressed (n = 166) with a low adhesive dressing (next day removal).
MAIN OUTCOME MEASURES


Primary outcomes were superficial SSI rate (assessed by provider inspection up to hospital discharge and telephone questionnaires on days 14 and 28) and patient satisfaction with wound coverage management before hospital discharge.
RESULTS


The superficial SSI rates were 2/153 (1.3%) versus 5/157 (3.2%) (relative risk [RR] 0.4, 95% CI 0.1-2.1; P = 0.45) and patient satisfaction with wound management was 7 [5-8] versus 7 [5-8] (P = 0.81) in exposed compared with dressed study groups, respectively. In the wound-exposed patients, stated preference for wound exposure significantly increased from 35.5 to 57.5%, whereas in the wound-dressed patients, the stated preference for a dressed wound fell from 48.5 to 34.4% when assessed at recruitment (pre-randomisation) to day 28. There were no significant differences in inpatient additional dressing or gauze use for wound care, post-hospital discharge self-reported wound issues of infection, antibiotics, redness and inflammation, swollen, painful, and fluid leakage to day 28 across trial groups.
CONCLUSION


The trial is underpowered as SSI rates were lower than expected. Nevertheless, leaving caesarean wounds exposed does not appear to have detrimental effects, provided patient counselling to manage expectations is undertaken.
TWEETABLE ABSTRACT


An exposed compared with a dressed caesarean wound has a similar superficial surgical site infection rate, patient satisfaction and appearance.",2020,"There were no significant differences in inpatient additional dressing or gauze use for wound care, post-hospital discharge self-reported wound issues of infection, antibiotics, redness and inflammation, swollen, painful, and fluid leakage to Day 28 across trial arms.
","['University Hospital, Malaysia: April 2016-October', '2016 POPULATION: 331 women delivered by Caesarean section METHOD']",['caesarean wound coverage'],"['inpatient additional dressing or gauze use for wound care, post-hospital discharge self-reported wound issues of infection, antibiotics, redness and inflammation, swollen, painful, and fluid leakage', 'SSI rates', 'patient satisfaction with wound management', 'stated preference for wound exposure', 'superficial SSI rate (assessed by provider inspection up to hospital discharge and telephone questionnaires on Day 14 and 28) and patient satisfaction with wound coverage management before hospital discharge RESULTS: The superficial SSI rates']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0021501', 'cui_str': 'wounds'}]","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0590323', 'cui_str': 'Gauzes (physical object)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0886052', 'cui_str': 'Administers care to wound sites'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0199219', 'cui_str': 'Visual observation'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.190025,"There were no significant differences in inpatient additional dressing or gauze use for wound care, post-hospital discharge self-reported wound issues of infection, antibiotics, redness and inflammation, swollen, painful, and fluid leakage to Day 28 across trial arms.
","[{'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Tan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rohani', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'McK', 'Initials': 'M', 'LastName': 'Lim', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Win', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'S Z', 'Initials': 'SZ', 'LastName': 'Omar', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16228']
205,32302790,"Comparative Healthcare Research Outcomes of Novel Surgery in prostate cancer (IP4-CHRONOS): A prospective, multi-centre therapeutic phase II parallel Randomised Control Trial.","INTRODUCTION


Focal therapy (FT) targets individual areas of cancer within the prostate, providing oncological control with minimal side-effects. Early evidence demonstrates encouraging short-medium-term outcomes. With no randomized controlled trials (RCT) comparing FT to radical therapies, Comparative Healthcare Research Outcomes of Novel Surgery in prostate cancer (CHRONOS) will compare the cancer control of these two strategies.
PATIENTS AND METHODS


CHRONOS is a parallel phase II RCT for patients with clinically significant non-metastatic prostate cancer, dependent upon clinician/patient decision, patients will enrol into either CHRONOS-A or CHRONOS-B. CHRONOS-A will randomize patients to either radical treatment or FT. CHRONOS-B is a multi-arm, multistage RCT comparing focal therapy alone to FT with neoadjuvant agents that might improve the current focal therapy outcomes. An internal pilot will determine the feasibility of, and compliance to, randomization. The proposed definitive study plans to recruit and randomize 1190 patients into CHRONOS-A and 1260 patients into CHRONOS-B.
RESULTS


Primary outcome in CHRONOS-A is progression-free survival (transition to salvage local or systemic therapy, development of metastases or prostate-cancer-related mortality) and in CHRONOS-B is failure-free survival (includes the above definition and recurrence of clinically significant prostate cancer after initial FT). Secondary outcomes include adverse events, health economics and functional outcomes measured using validated questionnaires. CHRONOS is powered to assess non-inferiority of FT compared to radical therapy in CHRONOS-A, and superiority of neoadjuvant agents with FT in CHRONOS-B.
CONCLUSION


CHRONOS will assess the oncological outcomes after FT compared to radical therapy and whether neoadjuvant treatments improve cancer control following one FT session.",2020,"CHRONOS is powered to assess non-inferiority of FT compared to radical therapy in CHRONOS-A, and superiority of neoadjuvant agents with FT in CHRONOS-B.
CONCLUSION


CHRONOS will assess the oncological outcomes after FT compared to radical therapy and whether neoadjuvant treatments improve cancer control following one FT session.","['patients with clinically significant non-metastatic prostate cancer', 'prostate cancer (IP4-CHRONOS', '1190 patients into CHRONOS-A and 1260 patients']","['Novel Surgery', 'radical treatment or FT']","['adverse events, health economics and functional outcomes measured using validated questionnaires', 'progression-free survival (transition to salvage local or systemic therapy, development of metastases or prostate-cancer-related mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C4759295', 'cui_str': 'Non-metastatic prostate cancer'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013560', 'cui_str': 'Medical Economics'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",1260.0,0.0411896,"CHRONOS is powered to assess non-inferiority of FT compared to radical therapy in CHRONOS-A, and superiority of neoadjuvant agents with FT in CHRONOS-B.
CONCLUSION


CHRONOS will assess the oncological outcomes after FT compared to radical therapy and whether neoadjuvant treatments improve cancer control following one FT session.","[{'ForeName': 'Deepika', 'Initials': 'D', 'LastName': 'Reddy', 'Affiliation': 'Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK; Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK. Electronic address: Deepika.reddy06@imperial.ac.uk.'}, {'ForeName': 'Taimur T', 'Initials': 'TT', 'LastName': 'Shah', 'Affiliation': 'Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK; Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Dudderidge', 'Affiliation': 'Department of Urology, University Hospital Southampton NHS Trust, Southampton, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'McCracken', 'Affiliation': 'Department of Urology, Sunderland Royal Hospital, Sunderland, UK; Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Manit', 'Initials': 'M', 'LastName': 'Arya', 'Affiliation': 'Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK; Department of Surgery and Interventional Sciences, University College London, University College Hospital, London, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Dobbs', 'Affiliation': 'Patient and Public Representative, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Emberton', 'Affiliation': 'Department of Surgery and Interventional Sciences, University College London, University College Hospital, London, UK.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Fiorentino', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Day', 'Affiliation': 'Imperial Clinical Trials Unit, Imperial College London, London, UK.'}, {'ForeName': 'Andrew Toby', 'Initials': 'AT', 'LastName': 'Prevost', 'Affiliation': 'Imperial Clinical Trials Unit, Imperial College London, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Staffurth', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sydes', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, London, UK.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Winkler', 'Affiliation': 'Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK; Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Hashim U', 'Initials': 'HU', 'LastName': 'Ahmed', 'Affiliation': 'Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK; Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105999']
206,31609489,Cleansing efficacy of waist-shaped inter-dental brushes. A randomized-controlled crossover study.,"OBJECTIVE


To compare the cleansing efficacy of waist-shaped versus cylindric inter-dental brushes in patients receiving supportive periodontal therapy.
MATERIALS AND METHODS


After sample size estimation, 20 periodontal maintenance patients diagnosed with periodontitis stage 3 were recruited. Brushing efficacy of waist-shaped and cylindric inter-dental brushes was evaluated in a randomized-controlled, examiner-blinded, two-period crossover study by assessment of the Turesky modification of Quigley-Hein plaque index (T-QHI) and the papillary bleeding index (PBI) at four sites per tooth.
RESULTS


Seventeen probands with 1,474 tooth sites finished the study. At baseline, median of overall T-QHI scores was 1.4 (interquartile range 1.38-1.92). After 1 month, T-QHI for waist-shaped inter-dental brushes was 1.24 (1.03-1.52); in 15 individuals, T-QHI 0 was the grade most often measured. T-QHI for cylindric brushes was 1.71 (1.18-2.29; p = .042), with T-QHI 0 being the grade most often measured only in seven individuals. The odds ratio for establishing plaque-free inter-dental sites with waist-shaped relative to cylindric brushes was 1.8 [95% CI 1.6-1.9] (p < .001; logistic regression analysis). There were no statistically significant differences between PBI levels of waist-shaped and cylindric brushes.
CONCLUSION


This study has demonstrated the superiority in cleansing efficacy of waist-shaped over cylindric inter-dental brushes in individuals receiving supportive periodontal treatment.",2020,"There were no statistically significant differences between PBI levels of waist-shaped and cylindric brushes.
","['individuals receiving supportive periodontal treatment', 'Seventeen probands with 1,474 tooth sites finished the study', '20 periodontal maintenance patients diagnosed with periodontitis stage 3 were recruited', 'patients receiving supportive periodontal therapy']","['waist-shaped and cylindric interdental brushes', 'waist-shaped interdental brushes', 'waist-shaped versus cylindric interdental brushes']","['Turesky-Quigley Hein plaque index (T-QHI) and the papillary bleeding index (PBI', 'PBI levels of waist-shaped and cylindric brushes', 'T-QHI for waist-shaped interdental brushes', 'median of overall T-QHI scores']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0702111', 'cui_str': 'Proband (finding)'}, {'cui': 'C0445330', 'cui_str': 'Tooth site (attribute)'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}]","[{'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0442104', 'cui_str': 'Interdental (qualifier value)'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}]","[{'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205312', 'cui_str': 'Papillary (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0442104', 'cui_str': 'Interdental (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.156129,"There were no statistically significant differences between PBI levels of waist-shaped and cylindric brushes.
","[{'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Schnabl', 'Affiliation': 'Department of Operative and Prosthetic Dentistry, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Goebel', 'Affiliation': 'Department of Medical Statistics, Informatics and Health Economics, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Kadletz', 'Affiliation': 'Department of Operative and Prosthetic Dentistry, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Gaenzer', 'Affiliation': 'Department of Operative and Prosthetic Dentistry, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Steiner', 'Affiliation': 'Department of Operative and Prosthetic Dentistry, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Laimer', 'Affiliation': 'University Hospital of Cranio-Maxillofacial and Oral Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Kapferer-Seebacher', 'Affiliation': 'Department of Operative and Prosthetic Dentistry, Medical University of Innsbruck, Innsbruck, Austria.'}]",Journal of clinical periodontology,['10.1111/jcpe.13210']
207,31228356,Effects of repetitive transcranial magnetic stimulation on children with low-function autism.,"BACKGROUND


Autism spectrum disorder (ASD) is a very complex neurodevelopmental disorder, characterized by social difficulties and stereotypical or repetitive behavior. Some previous studies using low-frequency repetitive transcranial magnetic stimulation (rTMS) have proven of benefit in ASD children.
METHODS


In this study, 32 children (26 males and six females) with low-function autism were enrolled, 16 children (three females and 13 males; mean ± SD age: 7.8 ± 2.1 years) received rTMS treatment twice every week, while the remaining 16 children (three females and 13 males; mean ± SD age: 7.2 ± 1.6 years) served as waitlist group. This study investigated the effects of rTMS on brain activity and behavioral response in the autistic children.
RESULTS


Peak alpha frequency (PAF) is an electroencephalographic measure of cognitive preparedness and might be a neural marker of cognitive function for the autism. Coherence is one way to assess the brain functional connectivity of ASD children, which has proven abnormal in previous studies. The results showed significant increases in the PAF at the frontal region, the left temporal region, the right temporal region and the occipital region and a significant increase of alpha coherence between the central region and the right temporal region. Autism Behavior Checklist (ABC) scores were also compared before and after receiving rTMS with positive effects shown on behavior.
CONCLUSION


These findings supported our hypothesis by demonstration of positive effects of combined rTMS neurotherapy in active treatment group as compared to the waitlist group, as the rTMS group showed significant improvements in behavioral and functional outcomes as compared to the waitlist group.",2019,"The results showed significant increases in the PAF at the frontal region, the left temporal region, the right temporal region and the occipital region and a significant increase of alpha coherence between the central region and the right temporal region.","['autistic children', '16 children (three females and 13 males; mean\xa0±\xa0SD age: 7.2\xa0±\xa01.6\xa0years) served as waitlist group', 'children with low-function autism', 'SD age: 7.8\xa0±\xa02.1\xa0years', 'Autism spectrum disorder (ASD', '32 children (26 males and six females) with low-function autism were enrolled, 16 children (three females and 13 males; mean\xa0±']","['repetitive transcranial magnetic stimulation', 'rTMS', 'low-frequency repetitive transcranial magnetic stimulation (rTMS']","['Autism Behavior Checklist (ABC) scores', 'behavioral and functional outcomes', 'alpha coherence', 'brain activity and behavioral response', 'PAF at the frontal region, the left temporal region, the right temporal region and the occipital region']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}]","[{'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0549224', 'cui_str': 'Frontal region'}, {'cui': 'C0039485', 'cui_str': 'Temporal Region'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0230005', 'cui_str': 'Occipital region structure'}]",32.0,0.0176346,"The results showed significant increases in the PAF at the frontal region, the left temporal region, the right temporal region and the occipital region and a significant increase of alpha coherence between the central region and the right temporal region.","[{'ForeName': 'Jian-Nan', 'Initials': 'JN', 'LastName': 'Kang', 'Affiliation': 'College of Electronic & Information Engineering, Hebei University, Baoding, China.'}, {'ForeName': 'Jia-Jia', 'Initials': 'JJ', 'LastName': 'Song', 'Affiliation': 'College of Electronic & Information Engineering, Hebei University, Baoding, China.'}, {'ForeName': 'Manuel F', 'Initials': 'MF', 'LastName': 'Casanova', 'Affiliation': 'Department of Biomedical Sciences, University of South Carolina School of Medicine Greenville Campus, Greenville Health System, Greenville, South Carolina.'}, {'ForeName': 'Estate M', 'Initials': 'EM', 'LastName': 'Sokhadze', 'Affiliation': 'Department of Biomedical Sciences, University of South Carolina School of Medicine Greenville Campus, Greenville Health System, Greenville, South Carolina.'}, {'ForeName': 'Xiao-Li', 'Initials': 'XL', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China.'}]",CNS neuroscience & therapeutics,['10.1111/cns.13150']
208,31228880,The time course of ineffective sham-blinding during low-intensity (1 mA) transcranial direct current stimulation.,"Studies using transcranial direct current stimulation (tDCS) typically compare an active protocol relative to a shorter sham (placebo) protocol. Both protocols are presumed to be perceptually identical on the scalp, and thus represent an effective method of delivering double-blinded experimental designs. However, participants often show above-chance accuracy when asked which condition involved active/sham retrospectively. We assessed the time course of sham-blinding during active and sham tDCS. We predicted that participants would be aware that the current is switched on for longer in the active versus sham protocol. Thirty-two adults were tested in a preregistered, double-blinded, within-subjects design. A forced-choice reaction time task was undertaken before, during and after active (10 min 1 mA) and sham (20 s 1 mA) tDCS. The anode was placed over the left primary motor cortex (C3) to target the right hand, and the cathode on the right forehead. Two probe questions were asked every 30 s: ""Is the stimulation on?"" and ""How sure are you?"". Distinct periods of non-overlapping confidence intervals were identified between conditions, totalling 5 min (57.1% of the total difference in stimulation time). These began immediately after sham ramp-down and lasted until the active protocol had ended. We therefore show a failure of placebo control during 1 mA tDCS. These results highlight the need to develop more effective methods of sham-blinding during transcranial electrical stimulation protocols, even when delivered at low-intensity current strengths.",2019,"Distinct periods of non-overlapping confidence intervals were identified between conditions, totalling 5 min (57.1% of the total difference in stimulation time).",['Thirty-two adults'],"['sham-blinding during active and sham tDCS', 'shorter sham (placebo', 'transcranial direct current stimulation (tDCS']",[],"[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],32.0,0.411108,"Distinct periods of non-overlapping confidence intervals were identified between conditions, totalling 5 min (57.1% of the total difference in stimulation time).","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Greinacher', 'Affiliation': 'School of Psychology, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Buhôt', 'Affiliation': 'School of Psychology, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Möller', 'Affiliation': 'School of Psychology, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Learmonth', 'Affiliation': 'School of Psychology, University of Glasgow, Glasgow, UK.'}]",The European journal of neuroscience,['10.1111/ejn.14497']
209,32304430,Comparative Evaluation of Central Corneal Thickness in Cross-Linked Keratoconic Eyes.,"PURPOSE


To compare the central corneal thickness (CCT) measurements measured by using the Pentacam Scheimpflug system with the CCT measured using ultrasound pachymetry (UP) and to compare the compatibility between the methods in normal, keratoconic, and cross-linked keratoconic corneas.
METHODS


The study included 50 eyes of 50 patients with keratoconus (keratoconus group), 50 eyes of 50 patients with progressive keratoconus who underwent corneal cross-linking treatment (CCL group), and 50 eyes of 50 healthy subjects (control group). Patients in the keratoconus and CCL groups were further classified into mild (mean keratometry [Km] ≤ 47 D) and moderate keratoconus subgroups (47.0 < Km < 52.0 D). CCT values were noted from the Pentacam Scheimpflug and UP.
RESULTS


The difference between the Pentacam and UP values was largest in the CCL group (-20.9 0.21.5 μm), followed by the keratoconus and control groups (-10.6 0.20.3 and 0.4 0.6.8 μm). The Pentacam and UP measurements were not comparable in the keratoconus and CCL groups (P = 0.001 and P < 0.001), whereas they were comparable in the control group (P = 0.62). In subgroup analysis, the 2 methods were comparable in the mild keratoconus subgroup (P = 0.12) and not comparable in the moderate keratoconus subgroup and in both mild and moderate subgroups of the CCL group (P = 0.001, P < 0.001 and P < 0.001).
CONCLUSIONS


Pentacam Scheimpflug tomography and UP can be used interchangeably in normal and mild keratoconic eyes, but not in moderate keratoconic and cross-linked keratoconic eyes. Pachymetry measurements from Scheimpflug must be interpreted with extreme caution with different methods before planning an invasive procedure in these eyes.",2020,"In subgroup analysis, the 2 methods were comparable in the mild keratoconus subgroup (P = 0.12) and not comparable in the moderate keratoconus subgroup and in both mild and moderate subgroups of the CCL group (P = 0.001, P < 0.001 and P < 0.001).
","['Cross-Linked Keratoconic Eyes', '50 eyes of 50 patients with keratoconus (keratoconus group), 50 eyes of 50 patients with progressive keratoconus who underwent corneal cross-linking treatment (CCL group), and 50 eyes of 50 healthy subjects (control group']",['CCL'],"['central corneal thickness (CCT) measurements', 'CCT values', 'Pentacam and UP values']","[{'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007537', 'cui_str': 'Cefaclor'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0007537', 'cui_str': 'Cefaclor'}]","[{'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1444588', 'cui_str': 'Ultrasound pachymetry'}]",50.0,0.0343386,"In subgroup analysis, the 2 methods were comparable in the mild keratoconus subgroup (P = 0.12) and not comparable in the moderate keratoconus subgroup and in both mild and moderate subgroups of the CCL group (P = 0.001, P < 0.001 and P < 0.001).
","[{'ForeName': 'Pinar', 'Initials': 'P', 'LastName': 'Kosekahya', 'Affiliation': 'Department of Ophthalmology, Ulucanlar Eye Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Koc', 'Affiliation': 'Department of Ophthalmology, Special Kayseri Maya Eye Hospital, Kayseri, Turkey.'}, {'ForeName': 'Kubra Ozdemir', 'Initials': 'KO', 'LastName': 'Yalcinsoy', 'Affiliation': 'Department of Ophthalmology, Ulucanlar Eye Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Dilara Ozkoyuncu', 'Initials': 'DO', 'LastName': 'Kocabas', 'Affiliation': 'Department of Ophthalmology, Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mustafa Ilker', 'Initials': 'MI', 'LastName': 'Toker', 'Affiliation': 'Department of Ophthalmology, Ulucanlar Eye Training and Research Hospital, Ankara, Turkey.'}]",Cornea,['10.1097/ICO.0000000000002339']
210,31835278,Architecting Process of Care: A randomized controlled study evaluating the impact of providing nonadherence information and pharmacist assistance to physicians.,"OBJECTIVE


To test the impact of connecting physicians, pharmacists, and patients to address medication nonadherence, and to compare different physician choice architectures.
DATA SOURCES AND STUDY SETTING


The study was conducted with 90 physicians and 2602 of their patients on medications treating chronic illness.
STUDY DESIGN


In this cluster randomized controlled trial, physicians were randomly assigned to an arm where the physician receives notification of patient nonadherence derived from real-time claims data, an arm where they receive this information and a pharmacist may contact patients either by default or by physician choice, and a control group. The primary outcome was resolving nonadherence within 30 days. We also considered physician engagement outcomes including viewing information about nonadherence and utilizing a pharmacist.
DATA COLLECTION


Physician engagement was constructed from metadata from the study website; adherence outcomes were constructed from medication claims.
PRINCIPAL FINDINGS


We see no differences between the treatment arms and control for the primary adherence outcome. The pharmacist intervention was 42 percentage points (95% CI: 28 pp-56 pp) more likely when it was triggered by default.
CONCLUSIONS


Access to a pharmacist and real-time nonadherence information did not improve patient adherence. Physician process of care was sensitive to choice architecture.",2020,"The pharmacist intervention was 42 percentage points (95% CI: 28 pp-56 pp) more likely when it was triggered by default.
","['Architecting Process of Care', '90 physicians and 2602 of their patients on medications treating chronic illness']","['physician receives notification of patient nonadherence derived from real-time claims data, an arm where they receive this information and a pharmacist may contact patients either by default or by physician choice, and a control group']","['resolving nonadherence within 30\xa0days', 'patient adherence']","[{'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}]","[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0422202', 'cui_str': 'Notifications (procedure)'}, {'cui': 'C0376405', 'cui_str': 'Patient Non-Compliance'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3714811', 'cui_str': 'Resolved (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1321605', 'cui_str': 'Patient Cooperation'}]",,0.10001,"The pharmacist intervention was 42 percentage points (95% CI: 28 pp-56 pp) more likely when it was triggered by default.
","[{'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McConnell', 'Affiliation': 'Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Rogers', 'Affiliation': 'Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Simeonova', 'Affiliation': 'Johns Hopkins Carey School of Business, Baltimore, Maryland.'}, {'ForeName': 'Ira B', 'Initials': 'IB', 'LastName': 'Wilson', 'Affiliation': 'Brown University School of Public Health, Providence, Rhode Island.'}]",Health services research,['10.1111/1475-6773.13243']
211,31358922,Progression and new onset of macular retinoschisis in myopic choroidal neovascularization eyes after Conbercept therapy: a post-hoc analysis.,"OBJECTIVES


The objective of this study is to evaluate the progression and new onset of macular retinoschisis (MRS) in the patients treated with intravitreal Conbercept injections for myopic choroidal neovascularization (mCNV).
METHODS


Post-hoc analysis of 160 mCNV patients included in SHINY study was performed to evaluate the impact of Conbercept injection on MRS in patients with mCNV undergoing intravitreal Conbercept injections. The patients were 3:1 randomized to the study group (three loading dose and thereafter pro re nata [PRN]) and the control group (3 months' sham injection, then one Conbercept injection at month 4 and thereafter PRN). MRS was assessed with optical coherence tomography by masked graders.
RESULTS


At baseline, 28 of 122 eyes in study group and 10 of 38 eyes in control group had MRS. At month 3, two patients showed MRS progression and one patient had new onset MRS in study group. No MRS progression nor new onset MRS was found in the control group. At final visit, the cumulative incidence of MRS was 1.3% (2/160). Both Spearman's correlation and multiple logistic regression demonstrated no association between the progression and new onset of MRS and intravitreal injection frequency (correlation coefficient = 0.017, P = 0.851 and odds ratio = 0.996, P = 0.982). In addition, baseline vitreoretinal adhesion was the most likely potential risk factor resulting in MRS progression (odds ratio = 4.566, P = 0.027). Furthermore, MRS progression was more likely to take place in outer retinal layers.
CONCLUSIONS


The progression and new onset of MRS was not associated with the frequency of intravitreal Conbercept injections.",2020,No MRS progression nor new onset MRS was found in the control group.,"['myopic choroidal neovascularization eyes after Conbercept therapy', '160 mCNV patients included in SHINY study', 'for myopic choroidal neovascularization (mCNV', 'patients with mCNV undergoing intravitreal Conbercept injections']","['Conbercept injection on MRS', 'intravitreal Conbercept injections']","['MRS', 'cumulative incidence of MRS', 'progression and new onset of MRS and intravitreal injection frequency', 'MRS progression nor new\xa0onset MRS', 'MRS progression', 'new onset MRS']","[{'cui': 'C3665926', 'cui_str': 'Myopic choroidal neovascularization'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]",,0.0474506,No MRS progression nor new onset MRS was found in the control group.,"[{'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Shiqi', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yuanzhi', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Ophthalmology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Minlu', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Fenglei', 'Initials': 'F', 'LastName': 'Kuang', 'Affiliation': 'R&D Center, Chengdu Kanghong Biotech Ltd., Sichuan, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Beijing Tongren Hospital, Capital Medical University, Peking, China.'}, {'ForeName': 'Fenghua', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China. shretina@sjtu.edu.cn.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China. xdsun@sjtu.edu.cn.""}]","Eye (London, England)",['10.1038/s41433-019-0516-x']
212,32304151,"Promoting physical activity through walking to treat childhood obesity, mainly for mild to moderate obesity.","BACKGROUND


There are no randomized controlled trials examining the effect of walking on childhood obesity.
METHODS


A randomized controlled trial was conducted between August 2014 and April 2015 in Japan. Elementary school children aged 6 to 12 years with a percentage overweight (%OW) of ≥20% were recruited. One hundred and ninety children wanted to participate in the program, and all were accepted. After viewing a video that promoted physical activity through walking, participants were randomly assigned to three groups: walking (≥10 000 steps on school holidays), limiting screen time (<90 min on weekdays and <150 min on school holidays), and a control group (no intervention). The primary outcome was a decrease in %OW after 3 months' intervention. Per protocol analysis was performed using 156 participants who fulfilled the inclusion criteria of a %OW ≥20%.
RESULTS


The mean %OW was 35 ± 7% before intervention. The mean reduction in %OW after intervention in the walking (n = 59), limiting ST (n = 46), and control (n = 51) groups were -4.06 ± 4.84, -1.97 ± 4.62, and -1.81 ± 3.64 percentage points, respectively. Reduction in %OW was significantly larger in the walking group than in the control group: adjusted mean difference, -2.18 percentage points (95% confidence interval, -3.85 to -0.52), P = 0.002. The intervention in children also had favorable effects on the lifestyles of their parents. The intention-to-treat analysis of all 190 participants showed comparable results.
CONCLUSION


Promoting physical activity through walking on school holidays may be an additional strategy for treating elementary school children with obesity.",2020,"Reduction in %OW was significantly larger in the walking group (adjusted mean difference, -2.18 percentage points [95% confidence interval, -3.85 to -0.52], P = 0.002) than in the control group.","['One hundred ninety children wanted to participate in the program, and all were accepted to participate in the intervention program', 'Elementary school children aged 6 to 12 years with a percent overweight (%OW) of ≥20% were recruited', 'August 2014 and April 2015 in Japan', 'elementary school children with obesity', '156 participants who fulfilled the inclusion criteria of a %OW ≥20']","['walking (≥10,000 steps on school holidays), limiting screen time (ST) (<90 min on weekdays and <150 min on school holidays), and a control group (no intervention']","['mean %OW', 'decrease in %OW']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0019843', 'cui_str': 'Holidays'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",190.0,0.055114,"Reduction in %OW was significantly larger in the walking group (adjusted mean difference, -2.18 percentage points [95% confidence interval, -3.85 to -0.52], P = 0.002) than in the control group.","[{'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Yoshinaga', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Kagoshima Medical Center, Kagoshima, Japan.'}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Miyazaki', 'Affiliation': 'Department of Pediatrics, Japan Community Health Care Organization Takaoka Fushiki Hospital, Takaoka, Japan.'}, {'ForeName': 'Machiko', 'Initials': 'M', 'LastName': 'Aoki', 'Affiliation': 'Aoki Internal Cardiology and Pediatric Clinic, Fukuoka, Japan.'}, {'ForeName': 'Hiromitsu', 'Initials': 'H', 'LastName': 'Ogata', 'Affiliation': 'Epidemiology and Biostatistics, Kagawa Nutrition University, Sakado, Japan.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Faculty of Nursing, Japanese Red Cross Hokkaido College of Nursing, Kitami, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Hamajima', 'Affiliation': ""Department of Endocrinology and Metabolism, Aichi Children's Health and Medical Center, Ohbu, Japan.""}, {'ForeName': 'Masakuni', 'Initials': 'M', 'LastName': 'Tokuda', 'Affiliation': 'Tokuda Kodomo Clinic, Amagasaki, Japan.'}, {'ForeName': 'Lisheng', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Child Health, Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Horigome', 'Affiliation': 'Department of Child Health, Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Hideto', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'National Institute of Public Health, Wako, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Nagashima', 'Affiliation': 'Aichi Saiseikai Rehabilitation Hospital, Nagoya, Japan.'}]",Pediatrics international : official journal of the Japan Pediatric Society,['10.1111/ped.14253']
213,31520543,A dual-strain Lactobacilli reuteri probiotic improves the treatment of residual pockets: A randomized controlled clinical trial.,"AIM


To examine the adjunctive effect of a Lactobacillus reuteri probiotic (ATCC PTA 5289 & DSM 17938) on the re-instrumentation of residual pockets.
MATERIALS AND METHODS


This randomized, double-blind, placebo-controlled study included 39 previously non-surgically treated periodontitis patients. A re-instrumentation was carried out, and probiotic and/or placebo drops were applied according to the study protocoll. Patients afterwards received lozenges to use 2×/day for 12 weeks. Probing pocket depth (PPD), recession, bleeding on probing and plaque levels were analysed, next to the microbiological impact.
RESULTS


No effects of the probiotic drops could be found. However, after 24 weeks, the overall PPD in the probiotic lozenges group (2.64 ± 0.33 mm) was significantly lower compared to the control lozenges (2.92 ± 0.42 mm). This difference was even more pronounced in moderate (4-6 mm) and deep (≥7 mm) pockets. In the probiotic lozenges group, there were also significantly more pockets converting from ≥4 mm at baseline to ≤3 mm at 24 weeks (67 ± 18% versus 54 ± 17%) and less sites in need for surgery (4 ± 4% versus 8 ± 6%). However, the probiotic products did not influence the microbiological counts of the periodontopathogens.
CONCLUSION


The adjunctive consumption of L. reuteri lozenges after re-instrumentation improved the PPD reduction, without an impact on pocket colonization with periodontopathogens.",2020,This difference was even more pronounced in moderate (4-6mm) and deep (≥7mm) pockets.,"['39 previously non-surgically treated periodontitis patients', 'residual pockets']","['placebo', 'Lactobacillus reuteri probiotic (ATCC PTA', 'strain Lactobacilli reuteri probiotic']","['microbiological counts', 'Probing pocket depth (PPD), recession, bleeding on probing and plaque levels', 'PPD reduction', 'overall PPD']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}, {'cui': 'C0080194', 'cui_str': 'Strains'}]","[{'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0333047', 'cui_str': 'Recession (morphologic abnormality)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",39.0,0.191428,This difference was even more pronounced in moderate (4-6mm) and deep (≥7mm) pockets.,"[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Laleman', 'Affiliation': 'Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Pauwels', 'Affiliation': 'Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Quirynen', 'Affiliation': 'Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Teughels', 'Affiliation': 'Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven, Leuven, Belgium.'}]",Journal of clinical periodontology,['10.1111/jcpe.13198']
214,32304486,Longitudinal corneal endothelial cell loss after corrective surgery for late in-the-bag IOL dislocation: a randomized clinical trial.,"PURPOSE


To compare safety regarding longitudinal corneal endothelial cell loss (ECL) after IOL exchange vs IOL repositioning for late in-the-bag IOL dislocation.
SETTING


Oslo University Hospital, Norway.
DESIGN


Prospective, parallel group, randomized clinical trial.
METHODS


During a 3-year period, 104 patients were randomly assigned to groups receiving either IOL exchange with retropupillary fixation of an iris-claw IOL (n = 50) or IOL repositioning by scleral suturing (n = 54). All operations were performed by 1 surgeon with an anterior approach. Endothelial cell density (ECD) and central corneal thickness were measured preoperatively and at 6 months, 1 year, and 2 years postoperatively. A linear mixed model was applied for the longitudinal analysis, where patients with at least 1 ECD measurement were included (n = 44 exchange; n = 50 repositioning). The main outcome measure was 2-year longitudinal ECL in IOL exchange compared with IOL repositioning.
RESULTS


The longitudinal ECL was similar between the IOL exchange (n = 44) and IOL repositioning (n = 50) groups during the 2 years of follow-up (17.5% vs 15.3%, P = .15). A subgroup analysis found no reason to advise against either method for patients with low preoperative ECD (<1500 cells/mm). The mean central corneal thickness was similar between the 2 groups and remained stable over 2 years of follow-up.
CONCLUSIONS


This randomized clinical trial of late in-the-bag IOL dislocation surgery found that exchanging the IOL was as safe as repositioning in terms of 2-year longitudinal ECL.",2020,"The longitudinal ECL was similar between the IOL exchange and IOL repositioning groups during the 2 years of follow-up (17.5% vs 15.3%, p = .15).","['patients with at least one ECD measurement were included (n = 44 exchange; n = 50 repositioning', 'Oslo University Hospital, Norway', '104 patients']","['intraocular lens (IOL) exchange vs IOL repositioning', 'corrective surgery', 'IOL exchange with retropupillary fixation of an iris-claw lens (n = 50) or IOL repositioning by scleral suturing']","['Longitudinal corneal endothelial cell loss', 'longitudinal corneal endothelial cell loss (ECL', 'mean CCT', '2-year longitudinal ECL in IOL exchange compared to IOL repositioning', 'Endothelial cell density (ECD) and central corneal thickness (CCT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0395541', 'cui_str': 'Reposition of lens of eye'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0022077', 'cui_str': 'Iris structure'}, {'cui': 'C0008919', 'cui_str': 'Claw'}, {'cui': 'C1444754', 'cui_str': 'Length'}]","[{'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C2717756', 'cui_str': 'Corneal endothelial cell loss'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0395541', 'cui_str': 'Reposition of lens of eye'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}]",104.0,0.11822,"The longitudinal ECL was similar between the IOL exchange and IOL repositioning groups during the 2 years of follow-up (17.5% vs 15.3%, p = .15).","[{'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Dalby', 'Affiliation': 'From the Department of Ophthalmology (Dalby, Kristianslund, Østern, Drolsum), Oslo Centre for Biostatistics and Epidemiology (Falk), Oslo University Hospital, Institute of Clinical Medicine, University of Oslo (Dalby, Drolsum), Oslo, Norway.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Kristianslund', 'Affiliation': ''}, {'ForeName': 'Atle Einar', 'Initials': 'AE', 'LastName': 'Østern', 'Affiliation': ''}, {'ForeName': 'Ragnhild Sørum', 'Initials': 'RS', 'LastName': 'Falk', 'Affiliation': ''}, {'ForeName': 'Liv', 'Initials': 'L', 'LastName': 'Drolsum', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000213']
215,31219668,A randomized study comparing regular care with a nurse-led clinic based on tight disease activity control and person-centred care in patients with rheumatoid arthritis with moderate/high disease activity: A 6-month evaluation.,"INTRODUCTION


A recent survey showed that 27% of rheumatoid arthritis (RA) patients had inadequately controlled disease activity. Hence, there is a need for new strategies aiming at improving patient outcomes. The aim of the present study was to evaluate the effect of a nurse-led clinic with frequent visits, treat-to-target and person-centred care of patients with established RA and moderate-to-high disease activity compared with patients receiving regular care.
METHODS


The study was a randomized, controlled trial over 26 weeks, with a nonrandomized extension to week 50. Patients were randomized to an intervention group (IG; nurse-led clinic) based on person-centred care, frequent visits and ""treat to target"", or to a control group (CG) which visited the clinic according to care as usual. The primary outcome was the difference in the DAS28 change between the IG and the CG groups.
RESULTS


A total of 332 patients were screened for eligibility, of which 70 were randomly assigned to either the IG (n = 36) or the CG (n = 34) group. The primary outcome was not met, although patients in the IG group tended to improve more than those in the CG group (difference: 0.43 (95% confidence interval [CI] -0.27, 1.13). In both the IG and CG groups, delta-DAS28 improved significantly. The European League Against Rheumatology moderate or good response was achieved by 76% (95% CI 58, 89) in the IG and 49% (95% CI 32, 65) in the CG group.
CONCLUSIONS


Disease activity tended to improve more with the nurse-led intervention compared with regular care, although the difference was not significant, probably partly due to the lack of statistical power.",2019,"The primary outcome was not met, although patients in the IG group tended to improve more than those in the CG group (difference: 0.43 (95% confidence interval [CI]","['patients with established RA and moderate-to-high disease activity compared with patients receiving regular care', 'patients with rheumatoid arthritis with moderate/high disease activity', '332 patients were screened for eligibility, of which 70']","['CG', 'regular care with a nurse-led clinic based on tight disease activity control and person-centred care', 'intervention group (IG; nurse-led clinic) based on person-centred care, frequent visits and ""treat to target"", or to a control group (CG) which visited the clinic according to care as usual']","['delta-DAS28', 'European League Against Rheumatology moderate or good response', 'DAS28 change']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C2718021', 'cui_str': 'Nurse-Led Clinics'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0453911', 'cui_str': 'Tights (physical object)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",332.0,0.0952046,"The primary outcome was not met, although patients in the IG group tended to improve more than those in the CG group (difference: 0.43 (95% confidence interval [CI]","[{'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Bergsten', 'Affiliation': 'Research and Development Department at Region of Halland, Halmstad, Sweden.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Almehed', 'Affiliation': 'Rheumatology Department, Sahlgrenska University Hospital, Goteborg, Sweden.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Baigi', 'Affiliation': 'Research and Development Department at Region of Halland, Halmstad, Sweden.'}, {'ForeName': 'Lennart T H', 'Initials': 'LTH', 'LastName': 'Jacobsson', 'Affiliation': 'Department of Rheumatology and Inflammation Research, University of Gothenburg, Goteborg, Sweden.'}]",Musculoskeletal care,['10.1002/msc.1403']
216,32275788,Omega-3 fatty acid supplementation for cystic fibrosis.,"BACKGROUND


Studies suggest that a diet rich in omega-3 essential fatty acids may have beneficial anti-inflammatory effects for chronic conditions such as cystic fibrosis. This is an updated version of a previously published review.
OBJECTIVES


To determine whether there is evidence that omega-3 polyunsaturated fatty acid supplementation reduces morbidity and mortality and to identify any adverse events associated with supplementation.
SEARCH METHODS


We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Date of last search: 01 April 2020. We also searched online study registries and contacted authors. Date of last search: 12 February 2020.
SELECTION CRITERIA


Randomised controlled trials in people with cystic fibrosis comparing omega-3 fatty acid supplements with placebo.
DATA COLLECTION AND ANALYSIS


Two authors independently selected studies for inclusion, extracted data and assessed the risk of bias of the studies. The quality of the evidence was assessed using GRADE.
MAIN RESULTS


The searches identified 23 studies; five studies with 106 participants (children and adults) were included; duration of studies and interventions differed. Two studies compared omega-3 fatty acids to olive oil for six weeks; one study compared omega-3 fatty acids and omega-6 fatty acids to control capsules (customised fatty acid blends) for three months; one study compared a liquid dietary supplement containing omega-3 fatty acids to one without for six months; and one study compared omega-3 fatty acids to a placebo for 12 months. Three studies had a low risk of bias for randomisation, but the risk was unclear in the remaining two studies; all studies had an unclear risk of bias for allocation concealment. Three of the studies adequately blinded participants; the risk of bias for selective reporting was high in one study and unclear for four studies. Two studies reported the number of respiratory exacerbations. At three months, one study (43 participants) reported no change in antibiotic usage. At 12 months the second study (15 participants) reported a reduction in the number of pulmonary exacerbations and cumulative antibiotic days in the supplement group compared to the previous year (no data for the control group); very low-quality evidence means we are unsure whether supplementation has any effect on this outcome. With regards to adverse events, one six-week study (12 participants) reported no difference in diarrhoea between omega-3 or placebo capsules; the very low-quality evidence means we are unsure if supplementation has any effect on this outcome. Additionally, one study reported an increase in steatorrhoea requiring participants to increase their daily dose of pancreatic enzymes, but three studies had already increased pancreatic enzyme dose at study begin so as to reduce the incidence of steatorrhoea. One study (43 participants) reported stomach pains at three months (treatment or control group not specified). One six-week study (19 participants) reported three asthma exacerbations leading to exclusion of participants since corticosteroid treatment could affect affect essential fatty acid metabolism. Four studies reported lung function. One six-week study (19 participants) reported an increase in forced expiratory volume in one second (FEV 1 ) (L) and forced vital capacity (FVC) (L), but the very low-quality evidence means we are unsure if supplementation has any effect on lung function. The remaining studies did not report any difference in lung function at three months (unit of measurement not specified) or at six months and one year (FEV 1  % predicted and FVC % predicted). No deaths were reported in any of the five studies. Four studies reported clinical variables. One study reported an increase in Schwachman score and weight alongside a reduction in sputum volume with supplementation compared to placebo at three months (data not analysable). However, three studies reported no differences in either weight at six weeks, in body mass index (BMI) standard deviation (SD) score at six months (very low-quality evidence) or BMI Z score at 12 months. Three studies reported biochemical markers of fatty acid status. One study showed an increase from baseline in both EPA and DHA content of serum phospholipids in the omega-3 group compared to placebo at three months and also a significant decrease in n-6/n-3 ratio in the supplement group compared to placebo; since the quality of the evidence is very low we are not certain that these changes are due to supplementation. One six-month cross-over study showed a higher EPA content of the neutrophil membrane in the supplement group compared to the placebo group, but, no difference in DHA membrane concentration. Furthermore, the leukotriene B 4  to leukotriene B 5  ratio was lower at six months in the omega-3 group compared to placebo. A one-year study reported a greater increase in the essential fatty acid profile and a decrease in AA levels in the treatment arm compared to placebo.
AUTHORS' CONCLUSIONS


This review found that regular omega-3 supplements may provide some limited benefits for people with cystic fibrosis with relatively few adverse effects: however, the quality of the evidence across all outcomes was very low. The current evidence is insufficient to draw firm conclusions or recommend routine use of these supplements in people with cystic fibrosis. A large, long-term, multicentre, randomised controlled study is needed to determine any significant therapeutic effect and to assess the influence of disease severity, dosage and duration of treatment. Future researchers should note the need for additional pancreatic enzymes when providing omega-3 supplementation or olive oil placebo capsules. More research is required to determine the exact dose of pancreatic enzyme required.",2020,At 12 months the second study (15 participants) reported a reduction in the number of pulmonary exacerbations and cumulative antibiotic days in the supplement group compared to the previous year (no data for the control group); very low-quality evidence means we are unsure whether supplementation has any effect on this outcome.,"['people with cystic fibrosis comparing', 'people with cystic fibrosis', 'cystic fibrosis', '106 participants (children and adults']","['omega-3 fatty acids and omega-6 fatty acids to control capsules (customised fatty acid blends', 'omega-3 fatty acids to a placebo', 'regular omega-3 supplements', 'omega-3 fatty acid supplements with placebo', 'omega-3 fatty acids to olive oil', 'placebo', 'omega-3 polyunsaturated fatty acid supplementation', 'liquid dietary supplement containing omega-3 fatty acids', 'Omega-3 fatty acid supplementation']","['diarrhoea', 'essential fatty acid metabolism', 'morbidity and mortality', 'antibiotic usage', 'Schwachman score and weight alongside a reduction in sputum volume', 'BMI Z score', 'EPA content of the neutrophil membrane', 'number of respiratory exacerbations', 'EPA and DHA content of serum phospholipids', 'essential fatty acid profile', 'lung function', 'n-6/n-3 ratio', 'body mass index (BMI) standard deviation (SD) score', 'number of pulmonary exacerbations and cumulative antibiotic days', 'AA levels', 'stomach pains', 'forced expiratory volume in one second (FEV 1 ) (L) and forced vital capacity (FVC) (L', 'DHA membrane concentration']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0133860', 'cui_str': 'Fatty Acids, Omega-6'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015686', 'cui_str': 'Fatty Acids, Essential'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0425514', 'cui_str': 'Sputum volume'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",43.0,0.265456,At 12 months the second study (15 participants) reported a reduction in the number of pulmonary exacerbations and cumulative antibiotic days in the supplement group compared to the previous year (no data for the control group); very low-quality evidence means we are unsure whether supplementation has any effect on this outcome.,"[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Watson', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital, Cambridge Biomedical Campus, Hills Road, Cambridge, UK, CB2 0QQ.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Stackhouse', 'Affiliation': 'Royal Papworth Hospital NHS Foundation Trust, Dietetics and Speech and Language Therapy, Papworth Road, Cambridge Biomedical Campus, Cambridge, UK, CB2 0AY.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD002201.pub6']
217,31320738,Relationship between duration and extent of oedema and visual acuity outcome with ranibizumab in diabetic macular oedema: A post hoc analysis of Protocol I data.,"BACKGROUND/OBJECTIVES


This post hoc analysis explores the relationship between residual oedema exposure after ranibizumab treatment initiation and long-term visual acuity outcome in eyes with centre-involved diabetic macular oedema (DMO).
SUBJECTS/METHODS


Eyes randomised to the ranibizumab + prompt or deferred laser treatment arms in the Protocol I trial and with observed central retinal thickness (CRT) readings at baseline and ≥1 follow-up visits (n = 367) were stratified by 1) oedema duration (number of study visits with CRT ≥ 250 µm during the first 52 weeks of ranibizumab treatment); and 2) oedema extent (amount of excess CRT [≥ 250 µm] at each study visit, averaged over the first 52 weeks). Associations between measures of residual oedema and best-corrected visual acuity (BCVA) were assessed in multiple regression analyses.
RESULTS


Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156. Eyes with the most persistent oedema gained (mean) 4.4 (95% CI 0.1─8.7) fewer Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 156 than eyes with the least persistent oedema (P = 0.044). Eyes with the greatest amount of oedema gained (mean) 9.3 (95% CI 4.0─14.5) fewer ETDRS letters at week 156 than eyes with the least amount of oedema (P < 0.001).
CONCLUSIONS


Macular oedema exposure over the first 52 weeks of ranibizumab treatment is a negative prognostic factor for long-term visual acuity improvement in centre-involved DMO.",2020,"Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156.","['diabetic macular oedema', 'eyes with centre-involved diabetic macular oedema (DMO']","['ranibizumab + prompt or deferred laser treatment', 'ranibizumab']","['oedema and visual acuity outcome', 'residual oedema and best-corrected visual acuity (BCVA', 'Oedema duration and oedema extent', 'ETDRS letters']","[{'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]",367.0,0.11728,"Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156.","[{'ForeName': 'Srinivas R', 'Initials': 'SR', 'LastName': 'Sadda', 'Affiliation': 'Doheny Eye Institute, Los Angeles, CA, USA. SSadda@doheny.org.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Campbell', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Pravin U', 'Initials': 'PU', 'LastName': 'Dugel', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix, AZ, USA.'}, {'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Holekamp', 'Affiliation': 'Pepose Vision Institute and Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Szilárd', 'Initials': 'S', 'LastName': 'Kiss', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Loewenstein', 'Affiliation': 'Department of Ophthalmology, Tel Aviv Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Augustin', 'Affiliation': 'Department of Ophthalmology, Staedtisches Klinikum Karlsruhe, Karlsruhe, Germany.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Shih', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Xiaoshu', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Blanton Eye Institute, Houston Methodist Hospital, Houston, TX, USA.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Whitcup', 'Affiliation': 'Jules Stein Eye Institute, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}]","Eye (London, England)",['10.1038/s41433-019-0522-z']
218,29668561,A Randomized Controlled Trial Comparing Nitazoxanide Plus Lactulose With Lactulose Alone in Treatment of Overt Hepatic Encephalopathy.,"BACKGROUND AND AIMS


Hepatic encephalopathy (HE) is a reversible spectrum of neuropsychiatric abnormalities associated with liver dysfunction. Lactulose is a nonabsorbable disaccharide presently used to treat HE. Nitazoxanide (NTZ) has a broad-spectrum activity against urease-producing bacteria, so it decreases ammonia production and is therefore expected to reverse the symptoms of HE. A previous pilot study on HE patients given NTZ and lactulose had encouraging results with regard to amelioration of the clinical picture. Patients showed improvement in mental status and the drug was well-tolerated. Results such as these are encouraging larger studies. The aim of this study was to compare the safety and adequacy of NTZ plus lactulose versus lactulose and placebo in management of overt HE.
METHODS


In total, 120 cirrhotic patients suffering from overt HE were randomly designated to take either NTZ plus lactulose (n=60) or lactulose and placebo (n=60). The Clinical Hepatic Encephalopathy Staging Scale (CHESS) score was assessed for all patients on inclusion to the study and 1 week from the start of treatment.
RESULTS


Both groups evinced an improvement in CHESS score at 1 week, yet the improvement was significantly better in the NTZ group as the score decreased from 4.15±2.09 to 0.00±0.00 compared with 4.96±2.29 to 1.28±0.91 in patients receiving lactulose and placebo (P-value <0.001).
CONCLUSIONS


NTZ significantly decreases the CHESS score and improves mental status in the form of patient alertness, orientation, response to stimulation, and ability to talk. NTZ is safe and well-tolerated apart from infrequent epigastric pain.",2019,"Both groups evinced an improvement in CHESS score at 1 week, yet the improvement was significantly better in the NTZ group as the score decreased from 4.15±2.09 to 0.00±0.00 compared with 4.96±2.29 to 1.28±0.91 in patients receiving lactulose and placebo (P-value <0.001).
","['HE patients given', '120 cirrhotic patients suffering from overt']","['NTZ plus lactulose versus lactulose and placebo', 'Nitazoxanide Plus Lactulose With Lactulose Alone', 'lactulose and placebo', 'placebo', 'NTZ plus lactulose', 'NTZ and lactulose', 'Lactulose', 'NTZ', 'Nitazoxanide (NTZ']","['Overt Hepatic Encephalopathy', 'CHESS score', 'Clinical Hepatic Encephalopathy Staging Scale (CHESS) score', 'CHESS score and improves mental status', 'mental status and the drug was well-tolerated']","[{'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439686', 'cui_str': 'Cirrhotic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1436435', 'cui_str': 'NTZ'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0068788', 'cui_str': 'nitazoxanide'}]","[{'cui': 'C0019151', 'cui_str': 'Portal-Systemic Encephalopathy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0278060', 'cui_str': 'Mental status'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]",120.0,0.158953,"Both groups evinced an improvement in CHESS score at 1 week, yet the improvement was significantly better in the NTZ group as the score decreased from 4.15±2.09 to 0.00±0.00 compared with 4.96±2.29 to 1.28±0.91 in patients receiving lactulose and placebo (P-value <0.001).
","[{'ForeName': 'Sherief', 'Initials': 'S', 'LastName': 'Abd-Elsalam', 'Affiliation': 'Tropical Medicine & Infectious Diseases, Tanta University Faculty of Medicine, Tanta.'}, {'ForeName': 'Ferial', 'Initials': 'F', 'LastName': 'El-Kalla', 'Affiliation': 'Tropical Medicine & Infectious Diseases, Tanta University Faculty of Medicine, Tanta.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Elwan', 'Affiliation': 'Tropical Medicine & Infectious Diseases, Tanta University Faculty of Medicine, Tanta.'}, {'ForeName': 'Rehab', 'Initials': 'R', 'LastName': 'Badawi', 'Affiliation': 'Tropical Medicine & Infectious Diseases, Tanta University Faculty of Medicine, Tanta.'}, {'ForeName': 'Nehad', 'Initials': 'N', 'LastName': 'Hawash', 'Affiliation': 'Tropical Medicine & Infectious Diseases, Tanta University Faculty of Medicine, Tanta.'}, {'ForeName': 'Shaimaa', 'Initials': 'S', 'LastName': 'Soliman', 'Affiliation': 'Public Health and community medicine, Menoufia University Faculty of Medicine, Menoufia, Egypt.'}, {'ForeName': 'Samah', 'Initials': 'S', 'LastName': 'Soliman', 'Affiliation': 'Tropical Medicine & Infectious Diseases, Tanta University Faculty of Medicine, Tanta.'}, {'ForeName': 'Walaa', 'Initials': 'W', 'LastName': 'Elkhalawany', 'Affiliation': 'Tropical Medicine & Infectious Diseases, Tanta University Faculty of Medicine, Tanta.'}, {'ForeName': 'Mennat-Allah', 'Initials': 'MA', 'LastName': 'ElSawaf', 'Affiliation': 'Tropical Medicine & Infectious Diseases, Tanta University Faculty of Medicine, Tanta.'}, {'ForeName': 'Asem', 'Initials': 'A', 'LastName': 'Elfert', 'Affiliation': 'Tropical Medicine & Infectious Diseases, Tanta University Faculty of Medicine, Tanta.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001040']
219,31240128,Comparison of abdominal compression devices in persons with abdominal paralysis due to spinal cord injury.,"Study Design


Single subject design with five subjects.
Objectives


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


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


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


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


Abdominal compression improves respiratory function and supports SBP in individuals with chronic SCI. Further research is needed to guide the development of an easy-to-use and physiologically supportive abdominal compression garment.",2019,"There are no significant differences between DBP, SaO 2 , or HR between participants' personal binders and no binder.","['persons with abdominal paralysis due to spinal cord injury', 'human volunteers', 'five subjects', 'individuals with chronic SCI', 'Setting\n\n\nPrivate residences in Pierce and King Counties, WA, USA.\nMethods']","['abdominal compression devices', 'alternative commercial abdominal compression garments', ' Randomly ordered test garments (tank, bodysuit']","['SBP and FEV 1 ', 'DBP, SaO 2 , or HR', 'SBP', 'respiratory function', 'Physiologic measurements: blood pressure (SBP, DBP), blood oxygen saturation (SaO 2 ), forced expiratory volume in one second (FEV 1 ), and heart rate (HR']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0522224', 'cui_str': 'Plegia'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0454792', 'cui_str': 'Offaly (geographic location)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C2985539', 'cui_str': 'Compression garment (physical object)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0009072', 'cui_str': 'Garments'}, {'cui': 'C0336821', 'cui_str': 'Tank - military vehicle (physical object)'}]","[{'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0199213', 'cui_str': 'Physiologic measurement'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen (observable entity)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",5.0,0.0276293,"There are no significant differences between DBP, SaO 2 , or HR between participants' personal binders and no binder.","[{'ForeName': 'Michaela de', 'Initials': 'M', 'LastName': 'Groot', 'Affiliation': '1University of Puget Sound, Tacoma, WA USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Swartz', 'Affiliation': '2University of Puget Sound, 1500 N Warner St. CMB 1030, 98416 Tacoma, WA USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hastings', 'Affiliation': '2University of Puget Sound, 1500 N Warner St. CMB 1030, 98416 Tacoma, WA USA.'}]",Spinal cord series and cases,['10.1038/s41394-019-0176-x']
220,32286906,Effects of Brief Nurse Advance Care Planning Intervention with Visual Materials on Goal-of-Care Preference of Japanese Elderly Patients with Chronic Disease: A Pilot Randomized-Controlled Trial.,"Purpose:  Advance care planning is an important component of quality palliative care. In Asian countries, few randomized clinical trials have been reported. This pilot randomized-controlled trial examined the effects of brief nurse intervention with visual materials on the goal-of-care preference, cardiopulmonary resuscitation (CPR) preference, and designation of a health care proxy.  Methods:  This randomized clinical trial was performed from January to February 2018 on elderly Japanese patients with chronic disease. The patients were randomly assigned to a control group (brief nurse intervention using verbal descriptions) or intervention group (using visual materials). The primary endpoint was goal-of-care preference, and secondary outcomes included the following: (1) CPR preference, (2) presence of a designated health care proxy, (3) knowledge of CPR, and (4) readiness for advance care planning. Outcome measures were obtained at baseline and just after completion of the intervention.  Results:  A total of 220 patients were enrolled (117 in the intervention group and 103 in the control group). All patients completed post-intervention measurement. There was no significant difference between the groups in any of the outcome measures, while <5% of the participants wanted life-prolonging care as the goal of care at the baseline. Before/after comparisons indicated that, in both groups, the number of participants who designated a health care proxy significantly increased (29% to 65% vs. 22% to 52%, respectively;  p  < 0.001 each); and the knowledge and readiness scores significantly increased. Moreover, there was a significant increase in the number of patients who did not want CPR (55% to 67% with a terminal condition,  p  = 0.003; 67% to 80% with a bedridden condition,  p  < 0.001) in the intervention group.  Conclusions:  Brief nurse intervention increased documentation of a patient-designated health care proxy and improved the knowledge of CPR and patient readiness. Visual materials might help patients to imagine the actual situation regarding CPR.",2020,"There was no significant difference between the groups in any of the outcome measures, while <5% of the participants wanted life-prolonging care as the goal of care at the baseline.","['January to February 2018 on elderly Japanese patients with chronic disease', '220 patients were enrolled (117 in the intervention group and 103 in the control group', 'Japanese Elderly Patients with Chronic Disease']","['nurse intervention with visual materials', 'control group (brief nurse intervention using verbal descriptions) or intervention group (using visual materials', 'Brief Nurse Advance Care Planning Intervention with Visual Materials']","['knowledge and readiness scores', 'Goal-of-Care Preference', 'goal-of-care preference, and secondary outcomes included the following: (1) CPR preference, (2) presence of a designated health care proxy, (3) knowledge of CPR, and (4) readiness for advance care planning', 'health care proxy']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0303409', 'cui_str': 'Indium-117'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2930505', 'cui_str': 'Goals of Care'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}]",220.0,0.0471153,"There was no significant difference between the groups in any of the outcome measures, while <5% of the participants wanted life-prolonging care as the goal of care at the baseline.","[{'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Kizawa', 'Affiliation': 'Department of Palliative Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Okada', 'Affiliation': 'Department of Health Communication, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Kawahara', 'Affiliation': 'Clinical Research Support Center, The University of Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Morita', 'Affiliation': 'Department of Palliative and Supportive Care, Palliative Care Team, Seirei Mikatahara General Hospital, Shizuoka, Japan.'}]",Journal of palliative medicine,['10.1089/jpm.2019.0512']
221,32286232,Impact of a Web-Based Exercise and Nutritional Education Intervention in Patients Who Are Obese With Hypertension: Randomized Wait-List Controlled Trial.,"BACKGROUND


Internet-based interventions are a promising strategy for promoting healthy lifestyle behaviors. These have a tremendous potential for delivering electronic health interventions in scalable and cost-effective ways. There is strong evidence that the use of these programs can lead to weight loss and can lower patients' average blood pressure (BP) levels. So far, few studies have investigated the effects of internet-based programs on patients who are obese with hypertension (HTN).
OBJECTIVE


The aim of this study is to investigate the short- and long-term efficacy, in terms of body composition and BP parameters, of a self-administered internet-based intervention involving different modules and learning techniques aimed at promoting lifestyle changes (both physical activity and healthy eating) in patients who are obese with HTN.
METHODS


A randomized wait-list controlled trial design was used. We recruited 105 adults with HTN who were overweight or obese and randomly assigned them to either a 3-month internet-based intervention group (n=55) or the wait-list control group (n=50). We assessed BMI (primary outcome), body fat mass (BFM), systolic (S)BP and diastolic (D)BP, blood glucose and insulin levels, physical activity levels, and functional capacity for aerobic exercise at Time 0 (preintervention) and Time 1 (postintervention). All the patients in the wait-list control group subsequently received the intervention, and a secondary within-group analysis, which also included these participants, was conducted at Time 2 (12-month follow-up).
RESULTS


A 2-way mixed analysis of covariance showed a significant decrease in BMI, BFM, and blood glucose at 3 months in the internet-based intervention group; the effect size for the BMI and BFM parameters was moderate to large, and there was also a borderline significant trend for DBP and insulin. These results were either maintained or improved upon at Time 2 and showed significant changes for BMI (mean difference -0.4, 95% CI -0.1 to -0.6; P=.005), BFM (mean difference -2.4, 95% CI -1.1 to -3.6; P<.001), DBP (mean difference -1.8, 95% CI -0.2 to -3.3; P=.03), and blood glucose (mean difference -2, 95% CI 0 to -4; P=.04).
CONCLUSIONS


Implementation of our self-administered internet-based intervention, which involved different learning techniques aimed to promote lifestyle changes, resulted in positive short- and long-term health benefits in patients who are obese with HTN.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03396302; https://clinicaltrials.gov/ct2/show/NCT03396302.",2020,There is strong evidence that the use of these programs can lead to weight loss and can lower patients' average blood pressure (BP) levels.,"['patients who are obese with hypertension (HTN', 'patients who are obese with HTN', 'Patients', 'Who Are Obese With Hypertension', '105 adults with HTN who were overweight or obese']","['3-month internet-based intervention group (n=55) or the wait-list control group', 'self-administered internet-based intervention involving different modules and learning techniques aimed at promoting lifestyle changes (both physical activity and healthy eating', 'Web-Based Exercise and Nutritional Education Intervention']","['DBP and insulin', 'blood pressure (BP) levels', 'BMI (primary outcome), body fat mass (BFM), systolic (S)BP and diastolic (D)BP, blood glucose and insulin levels, physical activity levels, and functional capacity for aerobic exercise at Time 0 (preintervention) and Time 1 (postintervention', 'BMI', 'blood glucose', 'DBP ', 'BFM', 'BMI and BFM parameters', 'BMI, BFM, and blood glucose']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0204934', 'cui_str': 'Nutrition education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",105.0,0.163935,There is strong evidence that the use of these programs can lead to weight loss and can lower patients' average blood pressure (BP) levels.,"[{'ForeName': 'Juan Francisco', 'Initials': 'JF', 'LastName': 'Lisón', 'Affiliation': 'Department of Medicine, Universidad Cardenal Herrera CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Palomar', 'Affiliation': 'Primary Care Health Center, Quartell, Spain.'}, {'ForeName': 'Marinna S', 'Initials': 'MS', 'LastName': 'Mensorio', 'Affiliation': 'Coordenação de Aperfeiçoamento de Pessoal de Nível Superior Foundation, Brasilia, Brazil.'}, {'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Baños', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología Obesidad y Nutrición, Instituto Carlos III, Madrid, Spain.'}, {'ForeName': 'Ausiàs', 'Initials': 'A', 'LastName': 'Cebolla-Martí', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología Obesidad y Nutrición, Instituto Carlos III, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Botella', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología Obesidad y Nutrición, Instituto Carlos III, Madrid, Spain.'}, {'ForeName': 'Vicent', 'Initials': 'V', 'LastName': 'Benavent-Caballer', 'Affiliation': 'Department of Physiotherapy, Universidad Cardenal Herrera CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Rodilla', 'Affiliation': 'Department of Medicine, Universidad Cardenal Herrera CEU, CEU Universities, Valencia, Spain.'}]",Journal of medical Internet research,['10.2196/14196']
222,31013550,Acute effects of cannabinoids on addiction endophenotypes are moderated by genes encoding the CB1 receptor and FAAH enzyme.,"Understanding genetic factors that contribute to cannabis use disorder (CUD) is important, but to date, findings have been equivocal. Single-nucleotide polymorphisms (SNPs) in the cannabinoid receptor 1 gene (CNR1; rs1049353 and rs806378) and fatty acid amide hydrolase (FAAH) gene (rs324420) have been implicated in CUD. Their relationship to addiction endophenotypes such as cannabis-related state satiety, the salience of appetitive cues, and craving after acute cannabinoid administration has not been investigated. Forty-eight cannabis users participated in a double-blind, placebo-controlled, four-way crossover experiment where they were administered treatments in a randomized order via vaporization: placebo, Δ 9  -tetrahydrocannabinol (THC) (8 mg), THC + cannabidiol (THC + CBD) (8 + 16 mg), and CBD (16 mg). Cannabis-related state satiety, appetitive cue salience (cannabis and food), and cannabis craving were assessed each day. Participants were genotyped for rs1049353, rs806378, and rs324420. Results indicated that CNR1 rs1049353 GG carriers showed increased state satiety after THC/THC + CBD administration in comparison with placebo and reduced the salience of appetitive cues after THC in comparison with CBD administration; A carriers did not vary on either of these measures indicative of a vulnerability to CUD. CNR1 rs806378 CC carriers showed greater salience to appetitive cues in comparison with T carriers, but there was no evidence for changes in state satiety. FAAH rs324420 A carriers showed greater bias to appetitive cues after THC, in comparison with CC carriers. FAAH CC carriers showed reduced bias after THC in comparison with CBD. No SNPs modulated craving. These findings identify candidate neurocognitive mechanisms through which endocannabinoid system genetics may influence vulnerability to CUD.",2020,"CNR1 rs806378 CC carriers showed greater salience to appetitive cues in comparison with T carriers, but there was no evidence for changes in state satiety.",['Forty-eight cannabis users'],"['placebo', 'vaporization: placebo, Δ 9  -tetrahydrocannabinol', 'FAAH CC', 'FAAH rs324420', 'THC\xa0+\xa0cannabidiol (THC\xa0+\xa0CBD']","['salience of appetitive cues', 'state satiety', 'Cannabis-related state satiety, appetitive cue salience (cannabis and food), and cannabis craving']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0581699', 'cui_str': 'Vaporization'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0870371', 'cui_str': 'Craving'}]",48.0,0.184911,"CNR1 rs806378 CC carriers showed greater salience to appetitive cues in comparison with T carriers, but there was no evidence for changes in state satiety.","[{'ForeName': 'Chandni', 'Initials': 'C', 'LastName': 'Hindocha', 'Affiliation': 'Clinical Psychopharmacology Unit, Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Freeman', 'Affiliation': 'Clinical Psychopharmacology Unit, Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Grainne', 'Initials': 'G', 'LastName': 'Schafer', 'Affiliation': 'Clinical Psychopharmacology Unit, Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Gardner', 'Affiliation': 'Clinical Psychopharmacology Unit, Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Michael A P', 'Initials': 'MAP', 'LastName': 'Bloomfield', 'Affiliation': 'Clinical Psychopharmacology Unit, Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Bramon', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Celia J A', 'Initials': 'CJA', 'LastName': 'Morgan', 'Affiliation': 'Clinical Psychopharmacology Unit, Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'H Valerie', 'Initials': 'HV', 'LastName': 'Curran', 'Affiliation': 'Clinical Psychopharmacology Unit, Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}]",Addiction biology,['10.1111/adb.12762']
223,31496465,Comparison of anthropometric indicators to predict mortality in a population-based prospective study of children under 5 years in Niger.,"OBJECTIVE


In the present study, we aimed to compare anthropometric indicators as predictors of mortality in a community-based setting.
DESIGN


We conducted a population-based longitudinal study nested in a cluster-randomized trial. We assessed weight, height and mid-upper arm circumference (MUAC) on children 12 months after the trial began and used the trial's annual census and monitoring visits to assess mortality over 2 years.
SETTING


Niger.
PARTICIPANTS


Children aged 6-60 months during the study.
RESULTS


Of 1023 children included in the study at baseline, height-for-age Z-score, weight-for-age Z-score, weight-for-height Z-score and MUAC classified 777 (76·0 %), 630 (61·6 %), 131 (12·9 %) and eighty (7·8 %) children as moderately to severely malnourished, respectively. Over the 2-year study period, fifty-eight children (5·7 %) died. MUAC had the greatest AUC (0·68, 95 % CI 0·61, 0·75) and had the strongest association with mortality in this sample (hazard ratio = 2·21, 95 % CI 1·26, 3·89, P = 0·006).
CONCLUSIONS


MUAC appears to be a better predictor of mortality than other anthropometric indicators in this community-based, high-malnutrition setting in Niger.",2020,"MUAC had the greatest AUC (0·68, 95 % CI 0·61, 0·75) and had the strongest association with mortality in this sample (hazard ratio = 2·21, 95 % CI 1·26, 3·89, P = 0·006).
","['Of 1023 children included in the study at baseline, height-for-age Z-score, weight-for-age Z-score, weight-for-height Z-score and MUAC', 'children under 5 years in Niger', 'Niger', 'Children aged 6-60 months during the study']",[],"['weight, height and mid-upper arm circumference (MUAC']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0424670', 'cui_str': 'Weight for height (observable entity)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0028074', 'cui_str': 'Republic of Niger'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",[],"[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference (observable entity)'}]",1023.0,0.0682445,"MUAC had the greatest AUC (0·68, 95 % CI 0·61, 0·75) and had the strongest association with mortality in this sample (hazard ratio = 2·21, 95 % CI 1·26, 3·89, P = 0·006).
","[{'ForeName': 'Kieran S', 'Initials': 'KS', 'LastName': ""O'Brien"", 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, 513 Parnassus Avenue, S334, San Francisco, CA 94143, USA.'}, {'ForeName': 'Abdou', 'Initials': 'A', 'LastName': 'Amza', 'Affiliation': 'Programme FSS/Université Abdou Moumouni de Niamey, Programme National de Santé Oculaire, Niamey, Niger.'}, {'ForeName': 'Boubacar', 'Initials': 'B', 'LastName': 'Kadri', 'Affiliation': 'Programme FSS/Université Abdou Moumouni de Niamey, Programme National de Santé Oculaire, Niamey, Niger.'}, {'ForeName': 'Beido', 'Initials': 'B', 'LastName': 'Nassirou', 'Affiliation': 'Programme FSS/Université Abdou Moumouni de Niamey, Programme National de Santé Oculaire, Niamey, Niger.'}, {'ForeName': 'Sun Y', 'Initials': 'SY', 'LastName': 'Cotter', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, 513 Parnassus Avenue, S334, San Francisco, CA 94143, USA.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Stoller', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, 513 Parnassus Avenue, S334, San Francisco, CA 94143, USA.'}, {'ForeName': 'Sheila K', 'Initials': 'SK', 'LastName': 'West', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Wilmer Eye Institute, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'Clinical Research Unit, Department of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, 513 Parnassus Avenue, S334, San Francisco, CA 94143, USA.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, 513 Parnassus Avenue, S334, San Francisco, CA 94143, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, 513 Parnassus Avenue, S334, San Francisco, CA 94143, USA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, 513 Parnassus Avenue, S334, San Francisco, CA 94143, USA.'}]",Public health nutrition,['10.1017/S1368980019002520']
224,31679945,"Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study.","BACKGROUND


Pembrolizumab is active in head and neck squamous cell carcinoma (HNSCC), with programmed cell death ligand 1 (PD-L1) expression associated with improved response.
METHODS


KEYNOTE-048 was a randomised, phase 3 study of participants with untreated locally incurable recurrent or metastatic HNSCC done at 200 sites in 37 countries. Participants were stratified by PD-L1 expression, p16 status, and performance status and randomly allocated (1:1:1) to pembrolizumab alone, pembrolizumab plus a platinum and 5-fluorouracil (pembrolizumab with chemotherapy), or cetuximab plus a platinum and 5-fluorouracil (cetuximab with chemotherapy). Investigators and participants were aware of treatment assignment. Investigators, participants, and representatives of the sponsor were masked to the PD-L1 combined positive score (CPS) results; PD-L1 positivity was not required for study entry. The primary endpoints were overall survival (time from randomisation to death from any cause) and progression-free survival (time from randomisation to radiographically confirmed disease progression or death from any cause, whichever came first) in the intention-to-treat population (all participants randomly allocated to a treatment group). There were 14 primary hypotheses: superiority of pembrolizumab alone and of pembrolizumab with chemotherapy versus cetuximab with chemotherapy for overall survival and progression-free survival in the PD-L1 CPS of 20 or more, CPS of 1 or more, and total populations and non-inferiority (non-inferiority margin: 1·2) of pembrolizumab alone and pembrolizumab with chemotherapy versus cetuximab with chemotherapy for overall survival in the total population. The definitive findings for each hypothesis were obtained when statistical testing was completed for that hypothesis; this occurred at the second interim analysis for 11 hypotheses and at final analysis for three hypotheses. Safety was assessed in the as-treated population (all participants who received at least one dose of allocated treatment). This study is registered at ClinicalTrials.gov, number NCT02358031.
FINDINGS


Between April 20, 2015, and Jan 17, 2017, 882 participants were allocated to receive pembrolizumab alone (n=301), pembrolizumab with chemotherapy (n=281), or cetuximab with chemotherapy (n=300); of these, 754 (85%) had CPS of 1 or more and 381 (43%) had CPS of 20 or more. At the second interim analysis, pembrolizumab alone improved overall survival versus cetuximab with chemotherapy in the CPS of 20 or more population (median 14·9 months vs 10·7 months, hazard ratio [HR] 0·61 [95% CI 0·45-0·83], p=0·0007) and CPS of 1 or more population (12·3 vs 10·3, 0·78 [0·64-0·96], p=0·0086) and was non-inferior in the total population (11·6 vs 10·7, 0·85 [0·71-1·03]). Pembrolizumab with chemotherapy improved overall survival versus cetuximab with chemotherapy in the total population (13·0 months vs 10·7 months, HR 0·77 [95% CI 0·63-0·93], p=0·0034) at the second interim analysis and in the CPS of 20 or more population (14·7 vs 11·0, 0·60 [0·45-0·82], p=0·0004) and CPS of 1 or more population (13·6 vs 10·4, 0·65 [0·53-0·80], p<0·0001) at final analysis. Neither pembrolizumab alone nor pembrolizumab with chemotherapy improved progression-free survival at the second interim analysis. At final analysis, grade 3 or worse all-cause adverse events occurred in 164 (55%) of 300 treated participants in the pembrolizumab alone group, 235 (85%) of 276 in the pembrolizumab with chemotherapy group, and 239 (83%) of 287 in the cetuximab with chemotherapy group. Adverse events led to death in 25 (8%) participants in the pembrolizumab alone group, 32 (12%) in the pembrolizumab with chemotherapy group, and 28 (10%) in the cetuximab with chemotherapy group.
INTERPRETATION


Based on the observed efficacy and safety, pembrolizumab plus platinum and 5-fluorouracil is an appropriate first-line treatment for recurrent or metastatic HNSCC and pembrolizumab monotherapy is an appropriate first-line treatment for PD-L1-positive recurrent or metastatic HNSCC.
FUNDING


Merck Sharp & Dohme.",2019,Neither pembrolizumab alone nor pembrolizumab with chemotherapy improved progression-free survival at the second interim analysis.,"['recurrent or metastatic squamous cell carcinoma of the head and neck', 'head and neck squamous cell carcinoma (HNSCC', '0·65', '0·61', 'Between April 20, 2015, and Jan 17, 2017, 882 participants', 'participants with untreated locally incurable recurrent or metastatic HNSCC done at 200 sites in 37 countries']","['pembrolizumab alone, pembrolizumab plus a platinum and 5-fluorouracil (pembrolizumab with chemotherapy), or cetuximab plus a platinum and 5-fluorouracil (cetuximab with chemotherapy', 'Pembrolizumab with chemotherapy', 'pembrolizumab', 'pembrolizumab alone', 'Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy', 'pembrolizumab plus platinum and 5-fluorouracil', 'pembrolizumab with chemotherapy (n=281), or cetuximab with chemotherapy', 'pembrolizumab alone and pembrolizumab with chemotherapy versus cetuximab with chemotherapy', 'cetuximab with chemotherapy', 'pembrolizumab alone nor pembrolizumab with chemotherapy', 'pembrolizumab with chemotherapy versus cetuximab with chemotherapy']","['adverse events', 'Safety', 'progression-free survival', 'hazard ratio [HR', 'overall survival', 'overall survival (time from randomisation to death from any cause) and progression-free survival', 'overall survival and progression-free survival']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}]",882.0,0.211751,Neither pembrolizumab alone nor pembrolizumab with chemotherapy improved progression-free survival at the second interim analysis.,"[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burtness', 'Affiliation': 'Yale School of Medicine and Yale Cancer Center, New Haven, CT, USA. Electronic address: barbara.burtness@yale.edu.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Harrington', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust National Institute of Health Research Biomedical Research Centre, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Paracelsus Medical University, Salzburg Cancer Research Institute, Salzburg, Austria; Cancer Cluster Salzburg, Salzburg, Austria.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Soulières', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Montréal, QC, Canada.""}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Tahara', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'de Castro', 'Affiliation': 'Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Psyrri', 'Affiliation': 'National Kapodistrian University of Athens, Attikon University Hospital, Athens, Greece.'}, {'ForeName': 'Neus', 'Initials': 'N', 'LastName': 'Basté', 'Affiliation': ""Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Neupane', 'Affiliation': 'University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Åse', 'Initials': 'Å', 'LastName': 'Bratland', 'Affiliation': 'Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Fuereder', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Brett G M', 'Initials': 'BGM', 'LastName': 'Hughes', 'Affiliation': ""Royal Brisbane and Women's Hospital and University of Queensland, Brisbane, QLD, Australia.""}, {'ForeName': 'Ricard', 'Initials': 'R', 'LastName': 'Mesía', 'Affiliation': 'Catalan Institute of Oncology, Hospitalet de Llobregat, Barcelona, Spain.'}, {'ForeName': 'Nuttapong', 'Initials': 'N', 'LastName': 'Ngamphaiboon', 'Affiliation': 'Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Rordorf', 'Affiliation': 'University Hospital, Zurich, Switzerland.'}, {'ForeName': 'Wan Zamaniah', 'Initials': 'WZ', 'LastName': 'Wan Ishak', 'Affiliation': 'University Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Ruey-Long', 'Initials': 'RL', 'LastName': 'Hong', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'González Mendoza', 'Affiliation': 'Unidad de Investigación en Salud, Chihuahua, Mexico.'}, {'ForeName': 'Ananya', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Yayan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Burak', 'Initials': 'B', 'LastName': 'Gumuscu', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Cheng', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Jin', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Rischin', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Austrialia; University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)32591-7']
225,30346317,Implementation of a Defecation Posture Modification Device: Impact on Bowel Movement Patterns in Healthy Subjects.,"GOALS


The goal of this study was to evaluate the influence of defecation postural modification devices (DPMDs) on normal bowel patterns.
BACKGROUND


The introduction of DPMDs has brought increased awareness to bowel habits in western populations.
MATERIALS AND METHODS


A prospective crossover study of volunteers was performed that included real-time collection of data regarding bowel movements (BMs) for 4 weeks (first 2 wk without DPMD and subsequent 2 wk with DPMD). Primary outcomes of interest included BM duration, straining, and bowel emptiness with and without DPMD use.
RESULTS


In total, 52 participants (mean age, 29 y and 40.1% female) were recruited for this study. At baseline 15 subjects (28.8%) reported incomplete emptying, 23 subjects (44.2%) had increased straining, and 29 subjects (55.8%) noticed blood on their toilet paper in the past year. A total of 1119 BMs were recorded (735 without DPMD and 384 with DPMD). Utilizing the DPMD resulted in increased bowel emptiness (odds ratio, 3.64; 95% confidence interval (CI), 2.78-4.77) and reduced straining patterns (odds ratio, 0.23; 95% CI, 0.18-0.30). Moreover, without the DPMD, participants had an increase in BM duration (fold increase, 1.25; 95% CI, 1.17-1.33).
CONCLUSIONS


DPMDs positively influenced BM duration, straining patterns, and complete evacuation of bowels in this study.",2019,"Utilizing the DPMD resulted in increased bowel emptiness (odds ratio, 3.64; 95% confidence interval (CI), 2.78-4.77) and reduced straining patterns (odds ratio, 0.23; 95% CI, 0.18-0.30).","['Healthy Subjects', '52 participants (mean age, 29\u2009y and 40.1% female']","['Defecation Posture Modification Device', 'defecation postural modification devices (DPMDs']","['BM duration', 'incomplete emptying', 'BM duration, straining, and bowel emptiness with and without DPMD use', 'bowel emptiness']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",1119.0,0.115148,"Utilizing the DPMD resulted in increased bowel emptiness (odds ratio, 3.64; 95% confidence interval (CI), 2.78-4.77) and reduced straining patterns (odds ratio, 0.23; 95% CI, 0.18-0.30).","[{'ForeName': 'Rohan M', 'Initials': 'RM', 'LastName': 'Modi', 'Affiliation': 'Department of Internal Medicine.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Hinton', 'Affiliation': 'Division of Biostatistics, College of Public Health, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pinkhas', 'Affiliation': 'Department of Internal Medicine.'}, {'ForeName': 'Royce', 'Initials': 'R', 'LastName': 'Groce', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, The Ohio State University Medical Center.'}, {'ForeName': 'Marty M', 'Initials': 'MM', 'LastName': 'Meyer', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, The Ohio State University Medical Center.'}, {'ForeName': 'Gokulakrishnan', 'Initials': 'G', 'LastName': 'Balasubramanian', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, The Ohio State University Medical Center.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Levine', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, The Ohio State University Medical Center.'}, {'ForeName': 'Peter P', 'Initials': 'PP', 'LastName': 'Stanich', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, The Ohio State University Medical Center.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001143']
226,29283904,Role of Full-spectrum Endoscopy in Colorectal Cancer Screening: Randomized Trial.,"GOALS


The aim of this study was to compare a new, full-spectrum endoscope (Fuse; EndoChoice, Alpharetta, GA) to standard forward-viewing colonoscopy in the detection of colorectal neoplasms.
BACKGROUND


Colonoscopy, the gold standard for the detection of colorectal cancer, fails to detect 22% to 28% of polyps, increasing the risk of interval cancer. Endoscopic improvement of the adenoma detection rate decrease interval carcinomas. Full-spectrum endoscopy (FUSE) (330-degree field of view), in a tandem study, has been shown to reduce the adenoma miss rate.
STUDY


Prospective, randomized study of 249 patients in patients referred from the colorectal screening program with a positive fecal occult blood test (FOBT). Patients were randomized to standard forward-viewing colonoscopy (170 degrees) or to full-spectrum colonoscopy with the Fuse system (330 degrees). Study variables were the adenoma detection rate, the polyp detection rate, the mean number of adenomas per procedure, the lesions detected according to the location, morphology and size, cecal intubation rate, total procedure time, insertion time to the cecum, therapeutic success, and adverse events.
RESULTS


The Fuse system did not produce a significantly higher adenoma detection rate than standard forward-viewing colonoscopy (FUSE 73.1% vs. standard colonoscopy 68.1%; P=0.47) but did have a significantly longer insertion time (FUSE 6.2 min vs. standard colonoscopy 4.2 min; P< 0.001). Further analysis failed to reveal any significant difference in polyp/adenoma detection rates by lesion size or colonic section.
CONCLUSIONS


FUSE did not detect significantly more colorectal neoplasia than forward viewing colonoscopy in a medium-risk CRC screening population with positive FOBT.",2019,The Fuse system did not produce a significantly higher adenoma detection rate than standard forward-viewing colonoscopy (FUSE 73.1% vs. standard colonoscopy 68.1%; P=0.47) but did have a significantly longer insertion time (FUSE 6.2 min vs. standard colonoscopy 4.2 min; P< 0.001).,"['249 patients in patients referred from the colorectal screening program with a positive fecal occult blood test (FOBT', 'Colorectal Cancer Screening']","['Full-spectrum Endoscopy', 'FUSE', 'standard forward-viewing colonoscopy (170 degrees) or to full-spectrum colonoscopy with the Fuse system', 'Full-spectrum endoscopy (FUSE', 'full-spectrum endoscope (Fuse; EndoChoice, Alpharetta, GA) to standard forward-viewing colonoscopy']","['adenoma detection rate, the polyp detection rate, the mean number of adenomas per procedure, the lesions detected according to the location, morphology and size, cecal intubation rate, total procedure time, insertion time to the cecum, therapeutic success, and adverse events', 'Endoscopic improvement of the adenoma detection rate decrease interval carcinomas', 'longer insertion time', 'adenoma detection rate', 'colorectal neoplasia', 'risk of interval cancer']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0201811', 'cui_str': 'Screening for occult blood in feces (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}]","[{'cui': 'C1532530', 'cui_str': 'Full spectrum'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0014243', 'cui_str': 'Endoscopes'}]","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0007531', 'cui_str': 'Cecum'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2919572', 'cui_str': 'Malignant neoplasm detection during interval between recommended screening examinations (finding)'}]",,0.0523335,The Fuse system did not produce a significantly higher adenoma detection rate than standard forward-viewing colonoscopy (FUSE 73.1% vs. standard colonoscopy 68.1%; P=0.47) but did have a significantly longer insertion time (FUSE 6.2 min vs. standard colonoscopy 4.2 min; P< 0.001).,"[{'ForeName': 'Henar', 'Initials': 'H', 'LastName': 'Núñez-Rodríguez', 'Affiliation': 'Gastroenterology Department.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Diez-Redondo', 'Affiliation': 'Gastroenterology Department.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Pérez-Miranda', 'Affiliation': 'Gastroenterology Department.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Gonzalez Sagrado', 'Affiliation': 'Investigation Department, Rio Hortega Hospital.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Conde', 'Affiliation': 'Investigation Department, Rio Hortega Hospital.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'De la Serna', 'Affiliation': 'Gastroenterology Department, University Rio Hortega Hospital, Valladolid, Spain.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000000975']
227,30742471,Therapeutic alliance across trauma-focused and non-trauma-focused psychotherapies among veterans with PTSD.,"Trauma-focused psychotherapies for posttraumatic stress disorder (PTSD) are not widely utilized. Clinicians report concerns that direct discussion of traumatic experiences could undermine the therapeutic alliance, which may negatively impact retention and outcome. Studies among adolescents with PTSD found no difference in alliance between trauma-focused and non-trauma-focused psychotherapies, but this has not been tested among adults. The present study is a secondary analysis of a randomized trial of collaborative care, also known as care management, for PTSD. We examined patient-reported therapeutic alliance among 117 veterans with PTSD who participated in cognitive processing therapy (CPT, now called CPT + A; n = 54) or non-trauma-focused supportive psychotherapy for PTSD (n = 73) at VA community outpatient clinics. We tested the hypothesis that alliance in CPT would be noninferior to (i.e., not significantly worse than) non-trauma-focused psychotherapy using patient ratings on the Revised Helping Alliance Questionnaire. Patients' therapeutic alliance scores were high across both groups (CPT: M = 5.13, SD = 0.71, 95% CI [4.96, 5.30]; non-trauma-focused psychotherapy: M = 4.89, SD = 0.64, 95% CI [4.73, 5.05]). The difference between groups (0.23, 95% CI [0.01, 0.48]) was less than the ""noninferiority margin"" based on suggested clinical cutoffs (0.58 points on a 1-6 scale). These results held even after adjusting for veterans' demographic and clinical characteristics and change in PTSD symptoms from baseline to follow-up. Although there are concerns that direct discussion of traumatic experiences could worsen therapeutic alliance, patients report similar levels of alliance in CPT and non-trauma-focused supportive psychotherapy. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"Studies among adolescents with PTSD found no difference in alliance between trauma-focused and non-trauma-focused psychotherapies, but this has not been tested among adults.","['veterans with PTSD', 'adolescents with PTSD', '117 veterans with PTSD who participated in cognitive processing therapy (CPT, now called CPT + A; n = 54) or non-trauma-focused supportive psychotherapy for PTSD (n = 73) at VA community outpatient clinics']",['Trauma-focused psychotherapies'],['therapeutic alliance scores'],"[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0221295', 'cui_str': 'Supportive psychotherapy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}]","[{'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]","[{'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0413662,"Studies among adolescents with PTSD found no difference in alliance between trauma-focused and non-trauma-focused psychotherapies, but this has not been tested among adults.","[{'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Chen', 'Affiliation': 'Health Services Research & Development, Center of Innovation for Veteran-Centered and Value-Driven Care, Veterans Affairs Puget Sound Health Care System.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Fortney', 'Affiliation': 'HSR&D COIN for Veteran-Centered and Value- Driven Care, Veterans Affairs Puget Sound Health Care System, and Department of Psychiatry & Behavioral Sciences, University of Washington School of Medicine.'}, {'ForeName': 'Hannah E', 'Initials': 'HE', 'LastName': 'Bergman', 'Affiliation': 'Veterans Affairs Puget Sound Health Care System.'}, {'ForeName': 'Kendall C', 'Initials': 'KC', 'LastName': 'Browne', 'Affiliation': 'Center of Excellence in Substance Abuse and Treatment, Corporal Michael J. Crescenz VA Medical Center.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Grubbs', 'Affiliation': 'VA San Diego Health Care System.'}, {'ForeName': 'Teresa J', 'Initials': 'TJ', 'LastName': 'Hudson', 'Affiliation': 'HSR&D, Central Arkansas Veterans Healthcare System.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Raue', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Washington School of Medicine.'}]",Psychological services,['10.1037/ser0000329']
228,32284380,"Safety, Pharmacokinetics, and Drug-Drug Interaction Potential of Intravenous Durlobactam, a β-Lactamase Inhibitor, in Healthy Subjects.","Durlobactam (DUR; also known as ETX2514) is a novel β-lactamase inhibitor with broad activity against Ambler class A, C, and D β-lactamases. Addition of DUR to sulbactam (SUL)  in vitro  restores SUL activity against clinical isolates of  Acinetobacter baumannii  The safety and pharmacokinetics (PK) of DUR alone and with SUL and/or imipenem-cilastatin (IMI-CIL) were evaluated in healthy subjects. This was a randomized, placebo-controlled study. In part A, subjects, including a cohort of elderly subjects (which received DUR at 1 g), received single ascending doses of DUR ranging from 0.25 to 8 g. In part B, multiple ascending doses of DUR ranging from 0.25 to 2 g were administered every 6 h (q6h) for 29 doses. In parts C and D, the drug-drug interaction (DDI) potential, including the safety, of DUR (1 g) with SUL (1 g) and/or IMI-CIL (0.5/0.5 g) was investigated after single and multiple doses. Plasma and urine concentrations of DUR, SUL, and IMI-CIL were determined. Among 124 subjects, DUR was generally safe and well tolerated when it was administered either alone or in combination with SUL and/or IMI-CIL. After single and multiple doses, DUR demonstrated linear dose-proportional exposure across the studied dose ranges. Renal excretion was a predominant clearance mechanism. No drug-drug interaction potential between DUR and SUL and/or IMI-CIL was identified. SUL-DUR at 1 g (of each component) administered q6h with a 3-h intravenous (i.v.) infusion is under development for the treatment of serious infections due to  A. baumannii  (This study has been registered at ClinicalTrials.gov under identifier NCT02971423.).",2020,"Among 124 subjects, DUR was generally safe and well tolerated either alone or in combination with SUL and/or IMI/CIL.","['124 subjects', 'Healthy Subjects', 'healthy subjects']","['SUL and/or imipenem/cilastatin (IMI/CIL', 'placebo', 'single ascending doses of DUR 0.25-8 g']","['safe and well tolerated', 'Renal excretion', 'Plasma and urine concentrations of DUR, SUL, and IMI/CIL']","[{'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0038665', 'cui_str': 'Sulbactam'}, {'cui': 'C0020933', 'cui_str': 'Imipenem'}, {'cui': 'C0008777', 'cui_str': 'Cilastatin'}, {'cui': 'C0340305', 'cui_str': 'Myocardial Infarction, Inferior Wall'}, {'cui': 'C0164683', 'cui_str': 'Cilest'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C1318217', 'cui_str': '8G'}]","[{'cui': 'C1373187', 'cui_str': 'Renal Excretion'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038665', 'cui_str': 'Sulbactam'}, {'cui': 'C0340305', 'cui_str': 'Myocardial Infarction, Inferior Wall'}, {'cui': 'C0164683', 'cui_str': 'Cilest'}]",124.0,0.0285004,"Among 124 subjects, DUR was generally safe and well tolerated either alone or in combination with SUL and/or IMI/CIL.","[{'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Lickliter', 'Affiliation': 'Nucleus Network, Melbourne, Australia.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Lawrence', 'Affiliation': 'Tetraphase Pharmaceuticals, Watertown, Massachusetts, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': ""O'Donnell"", 'Affiliation': 'Entasis Therapeutics, Inc., Waltham, Massachusetts, USA John.odonnell@entasistx.com.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Isaacs', 'Affiliation': 'Entasis Therapeutics, Inc., Waltham, Massachusetts, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00071-20']
229,32284384,"Phase 2a Pharmacokinetic, Safety, and Exploratory Efficacy Evaluation of Oral Gepotidacin (GSK2140944) in Female Participants with Uncomplicated Urinary Tract Infection (Acute Uncomplicated Cystitis).","Gepotidacin, a triazaacenaphthylene bacterial type II topoisomerase inhibitor, is in development for treatment of uncomplicated urinary tract infection (uUTI). This phase 2a study in female participants with uUTI evaluated the pharmacokinetics (primary objective), safety, and exploratory efficacy of gepotidacin. Eligible participants ( n  = 22) were confined to the clinic at baseline, received oral gepotidacin at 1,500 mg twice daily for 5 days (on-therapy period; days 1 to 5), and returned to the clinic for test-of-cure (days 10 to 13) and follow-up (day 28 ± 3) visits. Pharmacokinetic, safety, clinical, and microbiological assessments were performed. Maximum plasma concentrations were observed approximately 1.5 to 2 h postdose. Steady state was attained by day 3. Urinary exposure over the dosing interval increased from 3,742 μg·h/ml (day 1) to 5,973 μg·h/ml (day 4), with trough concentrations of 322 to 352 μg/ml from day 3 onward. Gepotidacin had an acceptable safety-risk profile with no treatment-limiting adverse events and no clinically relevant safety trends. Clinical success was achieved in 19 (86%) and 18 (82%) of 22 participants at test-of-cure and follow-up visits, respectively. Eight participants had a qualifying baseline uropathogen (growth; ≥10 5  CFU/ml). A therapeutic (combined clinical and microbiological [no growth; <10 3  CFU/ml]) successful response was achieved in 6 (75%) and 5 (63%) of 8 participants at test-of-cure and follow-up visits, respectively. Plasma area under the free-drug concentration-time curve over 24 h at steady state divided by the MIC ( f AUC 0-24 /MIC) and urine AUC 0-24 /MIC ranged from 6.99 to 90.5 and 1,292 to 121,698, respectively. Further evaluation of gepotidacin in uUTI is warranted. (This study has been registered in ClinicalTrials.gov under identifier NCT03568942.).",2020,Gepotidacin had an acceptable safety-risk profile with no treatment-limiting adverse events and no clinically relevant safety trends.,"['Eight participants had a qualifying baseline uropathogen (growth; ≥10 5  CFU/ml', 'Eligible participants (N = 22', 'female participants with uUTI', 'Female Participants With Uncomplicated Urinary Tract Infection (Acute Uncomplicated Cystitis']","['oral gepotidacin', 'Oral Gepotidacin (GSK2140944', 'urine AUC 0-24 /MIC']","['successful response', 'Pharmacokinetic, safety, clinical, and microbiological assessments', 'Maximum plasma concentrations', 'Plasma area under the free-drug concentration-time curve', 'Clinical success']","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439361', 'cui_str': 'cfu/mL'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4309999', 'cui_str': 'gepotidacin'}, {'cui': 'C4310555', 'cui_str': 'GSK2140944'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",22.0,0.0764344,Gepotidacin had an acceptable safety-risk profile with no treatment-limiting adverse events and no clinically relevant safety trends.,"[{'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Overcash', 'Affiliation': 'eStudySite, La Mesa, California, USA.'}, {'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Tiffany', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Scangarella-Oman', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Caroline R', 'Initials': 'CR', 'LastName': 'Perry', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA Caroline.R.Perry@gsk.com Etienne.F.Dumont@gsk.com.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hossain', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Barth', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Etienne F', 'Initials': 'EF', 'LastName': 'Dumont', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA Caroline.R.Perry@gsk.com Etienne.F.Dumont@gsk.com.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00199-20']
230,32053298,Plasma Exchange and Glucocorticoids in Severe ANCA-Associated Vasculitis.,"BACKGROUND


More effective and safer treatments are needed for antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.
METHODS


We conducted a randomized trial with a 2-by-2 factorial design to evaluate the use of plasma exchange and two regimens of oral glucocorticoids in patients with severe ANCA-associated vasculitis (defined by an estimated glomerular filtration rate of <50 ml per minute per 1.73 m 2  of body-surface area or diffuse pulmonary hemorrhage). Patients were randomly assigned to undergo plasma exchange (seven plasma exchanges within 14 days after randomization) or no plasma exchange (control group). Patients were also randomly assigned to follow either a standard-dose regimen or a reduced-dose regimen of oral glucocorticoids. Patients were followed for up to 7 years for the primary composite outcome of death from any cause or end-stage kidney disease (ESKD).
RESULTS


Death from any cause or ESKD occurred in 100 of 352 patients (28.4%) in the plasma-exchange group and in 109 of 352 patients (31.0%) in the control group (hazard ratio, 0.86; 95% confidence interval [CI], 0.65 to 1.13; P = 0.27). The results were similar in subgroup analyses and in analyses of secondary outcomes. We also assessed the noninferiority of a reduced-dose regimen of glucocorticoids to a standard-dose regimen, using a noninferiority margin of 11 percentage points. Death from any cause or ESKD occurred in 92 of 330 patients (27.9%) in the reduced-dose group and in 83 of 325 patients (25.5%) in the standard-dose group (absolute risk difference, 2.3 percentage points; 90% CI, -3.4 to 8.0), which met the criterion for noninferiority. Serious infections at 1 year were less common in the reduced-dose group than in the standard-dose group (incidence rate ratio, 0.69; 95% CI, 0.52 to 0.93), but other secondary outcomes were similar in the two groups.
CONCLUSIONS


Among patients with severe ANCA-associated vasculitis, the use of plasma exchange did not reduce the incidence of death or ESKD. A reduced-dose regimen of glucocorticoids was noninferior to a standard-dose regimen with respect to death or ESKD. (Funded by the U.K. National Institute for Health Research and others; PEXIVAS Current Controlled Trials number, ISRCTN07757494; ClinicalTrials.gov number, NCT00987389.).",2020,A reduced-dose regimen of glucocorticoids was noninferior to a standard-dose regimen with respect to death or ESKD.,"['patients with severe ANCA-associated vasculitis (defined by an estimated glomerular filtration rate of <50 ml per minute per 1.73 m 2  of body-surface area or diffuse pulmonary hemorrhage', 'patients with severe ANCA-associated vasculitis']","['plasma exchange (seven plasma exchanges within 14 days after randomization) or no plasma exchange (control group', 'standard-dose regimen or a reduced-dose regimen of oral glucocorticoids', 'glucocorticoids', 'oral glucocorticoids']","['Serious infections', 'Death', 'Death from any cause or ESKD', 'incidence of death or ESKD', 'death from any cause or end-stage kidney disease (ESKD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2717865', 'cui_str': 'Pauci-Immune Vasculitis'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C3811844'}, {'cui': 'C0702093', 'cui_str': '/min'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C0205219', 'cui_str': 'Diffuse (qualifier value)'}, {'cui': 'C0151701', 'cui_str': 'Pulmonary hemorrhage (disorder)'}]","[{'cui': 'C0032113', 'cui_str': 'Plasma Exchange'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}]",,0.369926,A reduced-dose regimen of glucocorticoids was noninferior to a standard-dose regimen with respect to death or ESKD.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Walsh', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Merkel', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Chen-Au', 'Initials': 'CA', 'LastName': 'Peh', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Wladimir M', 'Initials': 'WM', 'LastName': 'Szpirt', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Puéchal', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Shouichi', 'Initials': 'S', 'LastName': 'Fujimoto', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Carmel M', 'Initials': 'CM', 'LastName': 'Hawley', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Khalidi', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Floßmann', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Wald', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Louis P', 'Initials': 'LP', 'LastName': 'Girard', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Adeera', 'Initials': 'A', 'LastName': 'Levin', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Gregorini', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Harper', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Clark', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Pagnoux', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Specks', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Smyth', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Tesar', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Toshiko', 'Initials': 'T', 'LastName': 'Ito-Ihara', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Janak Rashme', 'Initials': 'JR', 'LastName': 'de Zoysa', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Szczeklik', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Luis Felipe', 'Initials': 'LF', 'LastName': 'Flores-Suárez', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Carette', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Guillevin', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Pusey', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Alina L', 'Initials': 'AL', 'LastName': 'Casian', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Biljana', 'Initials': 'B', 'LastName': 'Brezina', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mazzetti', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'McAlear', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Broadhurst', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Reidlinger', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Ives', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'David R W', 'Initials': 'DRW', 'LastName': 'Jayne', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1803537']
231,32285582,A cluster randomized controlled trial of a simplified 5-step handwashing technique versus a conventional 7-step handwashing technique among Chinese students with intellectual disabilities.,"OBJECTIVE


To compare the effects of the simplified 5-step and the conventional 7-Step hand hygiene programme in a cluster randomized controlled trial among students with intellectual disabilities.
METHOD


A total of 472 Chinese students with intellectual disabilities were randomized to either simplified 5-step or conventional 7-step hand hygiene programme. Assessments included handwashing technique, cleanliness and sick leave days.
RESULTS


Handwashing technique scores (g = 0.25, 95% CI [0.18, 0.32]) and hand cleanliness scores (g = 0.33, 95% CI [0.26, 0.4]) in intervention group were significantly higher than those scores in control group at 6th month post-intervention although there were significant increases in the scores within both groups. The mean number of sick leave days decreased between baseline and 10 month in both groups according to descriptive statistics.
CONCLUSIONS


It is feasible and effective to adopt the simplified 5-step intervention as a standardized handwashing technique for the population group with intellectual disabilities.",2020,"RESULTS


Handwashing technique scores (g = 0.25, 95% CI [0.18, 0.32]) and hand cleanliness scores (g = 0.33, 95% CI [0.26, 0.4]) in intervention group were significantly higher than those scores in control group at 6th month post-intervention although there were significant increases in the scores within both groups.","['Chinese students with intellectual disabilities', 'population group with intellectual disabilities', '472 Chinese students with intellectual disabilities', 'students with intellectual disabilities']","['simplified 5-step handwashing technique versus a conventional 7-step handwashing technique', 'simplified 5-step and the conventional 7-Step hand hygiene programme', 'simplified 5-step or conventional 7-step hand hygiene programme']","['handwashing technique, cleanliness and sick leave days', 'hand cleanliness scores', 'mean number of sick leave days']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C1257890', 'cui_str': 'Group'}]","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}]","[{'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0522513', 'cui_str': 'With cleanliness'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",472.0,0.0813514,"RESULTS


Handwashing technique scores (g = 0.25, 95% CI [0.18, 0.32]) and hand cleanliness scores (g = 0.33, 95% CI [0.26, 0.4]) in intervention group were significantly higher than those scores in control group at 6th month post-intervention although there were significant increases in the scores within both groups.","[{'ForeName': 'Regina L T', 'Initials': 'RLT', 'LastName': 'Lee', 'Affiliation': 'Faculty of Health and Medicine, School of Nursing and Midwifery, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Leung', 'Affiliation': 'Department of Applied Social Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Infection Control Branch, Centre for Health Protection, Hong Kong, Hong Kong.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Stephen W H', 'Initials': 'SWH', 'LastName': 'Kwok', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}]",Journal of applied research in intellectual disabilities : JARID,['10.1111/jar.12731']
232,31848609,"Walnuts and Vegetable Oils Containing Oleic Acid Differentially Affect the Gut Microbiota and Associations with Cardiovascular Risk Factors: Follow-up of a Randomized, Controlled, Feeding Trial in Adults at Risk for Cardiovascular Disease.","BACKGROUND


It is unclear whether the favorable effects of walnuts on the gut microbiota are attributable to the fatty acids, including α-linolenic acid (ALA), and/or the bioactive compounds and fiber.
OBJECTIVE


This study examined between-diet gut bacterial differences in individuals at increased cardiovascular risk following diets that replace SFAs with walnuts or vegetable oils.
METHODS


Forty-two adults at cardiovascular risk were included in a randomized, crossover, controlled-feeding trial that provided a 2-wk standard Western diet (SWD) run-in and three 6-wk isocaloric study diets: a diet containing whole walnuts (WD; 57-99 g/d walnuts; 2.7% ALA), a fatty acid-matched diet devoid of walnuts (walnut fatty acid-matched diet; WFMD; 2.6% ALA), and a diet replacing ALA with oleic acid without walnuts (oleic acid replaces ALA diet; ORAD; 0.4% ALA). Fecal samples were collected following the run-in and study diets to assess gut microbiota with 16S rRNA sequencing and Qiime2 for amplicon sequence variant picking.
RESULTS


Subjects had elevated BMI (30 ± 1 kg/m2), blood pressure (121 ± 2/77 ± 1 mmHg), and LDL cholesterol (120 ± 5 mg/dL). Following the WD, Roseburia [relative abundance (RA) = 4.2%, linear discriminant analysis (LDA) = 4], Eubacterium eligensgroup (RA = 1.4%, LDA = 4), LachnospiraceaeUCG001 (RA = 1.2%, LDA = 3.2), Lachnospiraceae UCG004 (RA = 1.0%, LDA = 3), and Leuconostocaceae (RA = 0.03%, LDA = 2.8) were most abundant relative to taxa in the SWD (P ≤ 0.05 for all). The WD was also enriched in Gordonibacter relative to the WFMD. Roseburia (3.6%, LDA = 4) and Eubacterium eligensgroup (RA = 1.5%, LDA = 3.4) were abundant following the WFMD, and Clostridialesvadin BB60group (RA = 0.3%, LDA = 2) and gutmetagenome (RA = 0.2%, LDA = 2) were most abundant following the ORAD relative to the SWD (P ≤ 0.05 for all). Lachnospiraceae were inversely correlated with blood pressure and lipid/lipoprotein measurements following the WD.
CONCLUSIONS


The results indicate similar enrichment of Roseburia following the WD and WFMD, which could be explained by the fatty acid composition. Gordonibacter enrichment and the inverse association between Lachnospiraceae and cardiovascular risk factors following the WD suggest that the gut microbiota may contribute to the health benefits of walnut consumption in adults at cardiovascular risk. This trial was registered at clinicaltrials.gov as NCT02210767.",2020,"RESULTS


Subjects had elevated BMI (30 ± 1 kg/m2), blood pressure (121 ± 2/77 ± ","['Forty-two adults at cardiovascular risk', 'Subjects had elevated BMI (30\xa0±\xa01\xa0kg/m2), blood pressure (121\xa0±\xa02/77\xa0±', 'individuals at increased cardiovascular risk following diets that replace', 'adults at cardiovascular risk', 'Adults at Risk for Cardiovascular Disease']","['2-wk standard Western diet (SWD) run-in and three 6-wk isocaloric study diets: a diet containing whole walnuts (WD; 57-99\xa0g/d walnuts; 2.7% ALA), a fatty acid-matched diet devoid of walnuts (walnut fatty acid-matched diet; WFMD; 2.6% ALA), and a diet replacing ALA with oleic acid without walnuts (oleic acid replaces ALA diet; ORAD', 'SFAs with walnuts or vegetable oils', 'Walnuts and Vegetable Oils Containing Oleic Acid']","['LDL cholesterol', 'Eubacterium eligensgroup', 'blood pressure and lipid/lipoprotein measurements', 'Lachnospiraceae UCG004']","[{'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3849996', 'cui_str': 'Western Dietary Pattern'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0993635', 'cui_str': 'English walnut'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C0028929', 'cui_str': 'Oleic Acids'}, {'cui': 'C0042438', 'cui_str': 'Vegetable Oils'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0015146', 'cui_str': 'Eubacterium'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0523753', 'cui_str': 'Lipoproteins measurement (procedure)'}, {'cui': 'C1210564', 'cui_str': 'Lachnospiraceae'}]",42.0,0.0586296,"RESULTS


Subjects had elevated BMI (30 ± 1 kg/m2), blood pressure (121 ± 2/77 ± ","[{'ForeName': 'Alyssa M', 'Initials': 'AM', 'LastName': 'Tindall', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'McLimans', 'Affiliation': 'Department of Biology, Juniata College, Huntingdon, PA, USA.'}, {'ForeName': 'Kristina S', 'Initials': 'KS', 'LastName': 'Petersen', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Penny M', 'Initials': 'PM', 'LastName': 'Kris-Etherton', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Lamendella', 'Affiliation': 'Department of Biology, Juniata College, Huntingdon, PA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz289']
233,32279888,Protection of an intraoral surgical wound with a new dressing: a randomised controlled clinical trial.,"Operations that involve the maxillofacial region often require intraoral incisions, and contamination of these wounds is common as a result of the presence of saliva, plaque, and food debris. Postoperative infection is therefore common. The aim of the study was to evaluate the clinical efficacy of an intraoral dressing material, Reso-Pac®, in improving postoperative comfort for patients and its effect on wound healing. One hundred patients who required removal of impacted mandibular third molars were recruited, and were randomised into two groups (50 in each). A standardised surgical technique was used for removal of the impacted teeth, and wounds were closed with sutures. Postoperatively, the study group was given Reso-Pac® dressing while the control group was not. Postoperative pain was measured using a visual analogue scale (VAS). Wound healing was assessed with the help of Landry's scale, and we also measured thermal sensitivity. Data were analysed using the paired t test. The results in the study group were significantly better than those in the control group (p<0.001). Reso-Pac® promoted wound healing and improved patients' comfort during the postoperative phase.",2020,The results in the study group were significantly better than those in the control group (p<0.001).,['One hundred patients who required removal of impacted mandibular third molars'],"['intraoral dressing material, Reso-Pac®', 'intraoral surgical wound with a new dressing']","['Postoperative pain', 'visual analogue scale (VAS', 'Wound healing', 'wound healing', 'clinical efficacy']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}]","[{'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0033036', 'cui_str': 'Atrial premature complex'}, {'cui': 'C0332803', 'cui_str': 'Surgical wound'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",100.0,0.0440613,The results in the study group were significantly better than those in the control group (p<0.001).,"[{'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Raghavan', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram Campus, Ramapuram, Chennai 600089, Tamil Nadu, India.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Panneerselvam', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram Campus, Ramapuram, Chennai 600089, Tamil Nadu, India. Electronic address: elavenilomfs@gmail.com.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Mudigonda', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram Campus, Ramapuram, Chennai 600089, Tamil Nadu, India.'}, {'ForeName': 'K K V B', 'Initials': 'KKVB', 'LastName': 'Raja', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram Campus, Ramapuram, Chennai 600089, Tamil Nadu, India.'}]",The British journal of oral & maxillofacial surgery,['10.1016/j.bjoms.2020.03.017']
234,31909809,Replacing Saturated Fats with Unsaturated Fats from Walnuts or Vegetable Oils Lowers Atherogenic Lipoprotein Classes Without Increasing Lipoprotein(a).,"BACKGROUND


Walnuts have established lipid-/lipoprotein-lowering properties; however, their effect on lipoprotein subclasses has not been investigated. Furthermore, the mechanisms by which walnuts improve lipid/lipoprotein concentrations are incompletely understood.
OBJECTIVES


We aimed to examine, as exploratory outcomes of this trial, the effect of replacing SFAs with unsaturated fats from walnuts or vegetable oils on lipoprotein subclasses, cholesterol efflux, and proprotein convertase subtilisin/kexin type 9 (PCSK9).
METHODS


A randomized, crossover, controlled-feeding study was conducted in individuals at risk of cardiovascular disease (CVD) (n = 34; 62% men; mean ± SD age 44 ± 10 y; BMI: 30.1 ± 4.9 kg/m2). After a 2-wk run-in diet (12% SFAs, 7% PUFAs, 12% MUFAs), subjects consumed the following diets, in randomized order, for 6 wk: 1) walnut diet (WD) [57-99 g/d walnuts, 7% SFAs, 16% PUFAs [2.7% α-linolenic acid (ALA)], 9% MUFAs]; 2) walnut fatty acid-matched diet [7% SFAs, 16% PUFAs (2.6% ALA), 9% MUFAs]; and 3) oleic acid replaces ALA diet (ORAD) [7% SFAs, 14% PUFAs (0.4% ALA); 12% MUFAs] (all percentages listed are of total kilocalories ). Serum collected after the run-in (baseline) and each diet period was analyzed for lipoprotein classes and subclasses (vertical auto profile), cholesterol efflux, and PCSK9. Linear mixed models were used for data analysis.
RESULTS


Compared with the ORAD, total cholesterol (mean ± SEM -8.9± 2.3 mg/dL; -5.1%; P < 0.001), non-HDL cholesterol (-7.4 ± 2.0 mg/dL; -5.4%; P = 0.001), and LDL cholesterol (-6.9 ± 1.9 mg/dL; -6.5%; P = 0.001) were lower after the WD; no other pairwise differences existed. There were no between-diet differences for HDL-cholesterol or LDL-cholesterol subclasses. Lipoprotein(a) [Lp(a)], cholesterol efflux, and PCSK9 were unchanged after the diets.
CONCLUSIONS


In individuals at risk of CVD, replacement of SFAs with unsaturated fats from walnuts or vegetable oils improved lipid/lipoprotein classes, including LDL-cholesterol, non-HDL cholesterol, and total cholesterol, without an increase in Lp(a). These improvements were not explained by changes in cholesterol efflux capacity or PCSK9. This trial was registered at clinicaltrials.gov as NCT01235832.",2020,"Compared with the ORAD, total cholesterol (mean ± SEM -8.9± 2.3 mg/dL; -5.1%; P < 0.001), non-HDL cholesterol (-7.4 ± 2.0 mg/dL; -5.4%; P = 0.001), and LDL cholesterol (-6.9 ± 1.9 mg/dL; -6.5%; P = 0.001) were lower after the WD; no other pairwise differences existed.","['10', 'individuals at risk of cardiovascular disease (CVD) (n =\xa034; 62% men; mean ± SD age 44\xa0±', 'Lipoprotein(a']","['Replacing Saturated Fats with Unsaturated Fats from Walnuts or Vegetable Oils', 'replacing SFAs with unsaturated fats from walnuts or vegetable oils', 'walnut fatty acid-matched diet [7% SFAs, 16% PUFAs (2.6% ALA), 9% MUFAs]; and 3) oleic acid replaces ALA diet (ORAD) [7% SFAs, 14% PUFAs (0.4% ALA); 12% MUFAs']","['lipid/lipoprotein concentrations', 'lipoprotein subclasses, cholesterol efflux, and proprotein convertase subtilisin/kexin type 9 (PCSK9', 'Lp(a)], cholesterol efflux, and PCSK9', 'cholesterol efflux capacity or PCSK9', 'LDL cholesterol', 'HDL-cholesterol or LDL-cholesterol subclasses', 'ORAD, total cholesterol', 'lipid/lipoprotein classes, including LDL-cholesterol, non-HDL cholesterol, and total cholesterol, without an increase in Lp(a', 'non-HDL cholesterol']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C0015678', 'cui_str': 'Fats, Unsaturated'}, {'cui': 'C0993635', 'cui_str': 'English walnut'}, {'cui': 'C0042438', 'cui_str': 'Vegetable Oils'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C0028929', 'cui_str': 'Oleic Acids'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0445604', 'cui_str': 'Subclass (attribute)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1100660', 'cui_str': 'Proprotein Convertases'}, {'cui': 'C0038601', 'cui_str': 'Subtilisins'}, {'cui': 'C0165249', 'cui_str': 'kexin protein, S cerevisiae'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",,0.158711,"Compared with the ORAD, total cholesterol (mean ± SEM -8.9± 2.3 mg/dL; -5.1%; P < 0.001), non-HDL cholesterol (-7.4 ± 2.0 mg/dL; -5.4%; P = 0.001), and LDL cholesterol (-6.9 ± 1.9 mg/dL; -6.5%; P = 0.001) were lower after the WD; no other pairwise differences existed.","[{'ForeName': 'Alyssa M', 'Initials': 'AM', 'LastName': 'Tindall', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Penny M', 'Initials': 'PM', 'LastName': 'Kris-Etherton', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Kristina S', 'Initials': 'KS', 'LastName': 'Petersen', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz313']
235,31909811,Provision of Lipid-Based Nutrient Supplements to Mothers During Pregnancy and 6 Months Postpartum and to Their Infants from 6 to 18 Months Promotes Infant Gut Microbiota Diversity at 18 Months of Age but Not Microbiota Maturation in a Rural Malawian Setting: Secondary Outcomes of a Randomized Trial.,"BACKGROUND


Diet may alter the configuration of gut microbiota, but the impact of prenatal and postnatal nutritional interventions on infant gut microbiota has not been investigated.
OBJECTIVE


We evaluated whether providing lipid-based nutrient supplements (LNSs) to mother-infant dyads promotes a more diverse and mature infant gut microbiota, compared to maternal supplementation with multiple micronutrients (MMN) or iron and folic acid (IFA).
METHODS


We enrolled 869 pregnant women in a randomized trial in Malawi. There were 3 study groups, with women receiving 1 MMN capsule daily during pregnancy and 6 mo postpartum, or 1 LNS sachet (20 g) daily during pregnancy and 6 mo postpartum, or 1 IFA capsule daily (during pregnancy) then a placebo daily (postpartum). Infants in the LNS group received LNS from 6 to 18 mo; infants in the other groups did not receive supplements. The infants' fecal microbiota were characterized by PCR amplification and sequencing of the bacterial 16S rRNA gene (variable region 4). The primary outcomes were microbiota α diversity and maturation [as microbiota-for-age z score (MAZ)]. Specific associations of taxa with intervention were established with indicator species analysis (ISA).
RESULTS


Primary outcomes did not differ between IFA and MMN groups, so these groups were combined (IFA + MMN). Mean ± SD α diversity was higher in the LNS group at 18 mo for Shannon index [3.01 ± 0.57 (LNS) compared with 2.91 ± 0.60 (IFA + MMN), P = 0.032] and Pielou's evenness index [0.61 ± 0.08 (LNS) compared with 0.60 ± 0.09 (IFA + MMN), P = 0.043]; no significant differences were observed at 1, 6, 12, or 30 mo. MAZ and β diversity did not differ at any age. We found 10 and 3 operational taxonomic units (OTUs) positively associated with LNS and IFA + MMN, respectively; however, these associations became nonsignificant following false discovery rate correction at 10%.
CONCLUSIONS


Prenatal and postnatal LNS intake promoted infant gut microbiota diversity at 18 mo, after 12 mo of child supplementation, but did not alter microbiota maturation. This trial was registered at clinicaltrials.gov as NCT01239693.",2020,"We found 10 and 3 operational taxonomic units (OTUs) positively associated with LNS and IFA + MMN, respectively; however, these associations became nonsignificant following false discovery rate correction at 10%.
","['women receiving 1 MMN capsule daily during pregnancy and 6\xa0mo postpartum, or 1 LNS sachet (20 g) daily during pregnancy and 6', '869 pregnant women in a randomized trial in Malawi', 'Mothers During Pregnancy and 6 Months Postpartum and to Their Infants from 6 to 18 Months Promotes Infant Gut Microbiota Diversity at 18 Months of Age but Not Microbiota Maturation in a Rural Malawian Setting']","['Lipid-Based Nutrient Supplements', 'lipid-based nutrient supplements (LNSs', 'maternal supplementation with multiple micronutrients (MMN) or iron and folic acid (IFA', 'Prenatal and postnatal LNS intake', 'LNS']","['microbiota α diversity and maturation [as microbiota-for-age z score (MAZ', 'SD α diversity', 'Mean\xa0±', 'infant gut microbiota diversity', 'microbiota maturation']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C4319662', 'cui_str': 'Sachet'}, {'cui': 'C0450403', 'cui_str': '20G (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}]","[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}]",869.0,0.248488,"We found 10 and 3 operational taxonomic units (OTUs) positively associated with LNS and IFA + MMN, respectively; however, these associations became nonsignificant following false discovery rate correction at 10%.
","[{'ForeName': 'Arox W', 'Initials': 'AW', 'LastName': ""Kamng'ona"", 'Affiliation': 'Department of Biomedical Sciences, University of Malawi, College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Young', 'Affiliation': 'Institute for Global Nutrition and Department of Nutrition, University of California, Davis, Davis, CA 95616, USA.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Institute for Global Nutrition and Department of Nutrition, University of California, Davis, Davis, CA 95616, USA.'}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Patson', 'Affiliation': 'School of Public Health and Family Medicine, University of Malawi, College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Josh M', 'Initials': 'JM', 'LastName': 'Jorgensen', 'Affiliation': 'Institute for Global Nutrition and Department of Nutrition, University of California, Davis, Davis, CA 95616, USA.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Kortekangas', 'Affiliation': 'Center for Child Health Research, University of Tampere Faculty of Medicine and Life Sciences, 33100 Tampere, Finland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chaima', 'Affiliation': 'School of Public Health and Family Medicine, University of Malawi, College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Chikondi', 'Initials': 'C', 'LastName': 'Malamba', 'Affiliation': 'School of Public Health and Family Medicine, University of Malawi, College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Ashorn', 'Affiliation': 'Center for Child Health Research, University of Tampere Faculty of Medicine and Life Sciences, 33100 Tampere, Finland.'}, {'ForeName': 'Yin B', 'Initials': 'YB', 'LastName': 'Cheung', 'Affiliation': 'Program in Health Services & Systems Research and Center for Quantitative Medicine, Duke-NUS Medical School, Singapore 169857.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': 'Center for Child Health Research, University of Tampere Faculty of Medicine and Life Sciences, 33100 Tampere, Finland.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Maleta', 'Affiliation': 'School of Public Health and Family Medicine, University of Malawi, College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Institute for Global Nutrition and Department of Nutrition, University of California, Davis, Davis, CA 95616, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz298']
236,32282356,Corneal Haze After Transepithelial Collagen Cross-linking for Keratoconus: A Scheimpflug Densitometry Analysis.,"PURPOSE


To quantitate corneal haze and analyze the postoperative time course of corneal haze after transepithelial corneal collagen cross-linking (TECXL) in patients with keratoconus.
METHODS


Patients underwent TECXL and were randomized into 2 groups. One group received intraoperative riboflavin 0.10% every minute, and the second group received riboflavin 0.10% every 2 minutes during ultraviolet exposure. Scheimpflug densitometry was measured preoperatively, and at 1, 3, 6, and 12 months to assess the postoperative time course. Densitometry measurements were also correlated with visual acuity, pachymetry, and topography outcomes.
RESULTS


Fifty-nine eyes of 43 patients with keratoconus were analyzed. Preoperative mean corneal densitometry was 20.45 ± 2.79. Mean densitometry increased at 1 month (22.58 ± 3.79; P < 0.001), did not significantly change between 1 and 3 months (22.64 ± 3.83; P = 0.8), and significantly improved between 3 and 12 months postoperatively (mean6 21.59 ± 3.39; P = 0.002, mean12 20.80 ± 3.27; P = 0.002). There was no difference between preoperative and 1-year densitometry measurements (P = 0.21). There was no significant difference between the 1-minute and 2-minute subgroups. In addition, corneal densitometry at either 3 months or 1 year did not correlate with uncorrected distance visual acuity (P = 0.4), corrected distance visual acuity (P = 0.1), or maximum keratometry (P = 0.5), 1 year after corneal collagen cross-linking (CXL).
CONCLUSIONS


After TECXL, corneal haze increased slightly at 1 month, plateaued between 1 and 3 months, and returned to baseline between 3 and 12 months. In general, corneal haze in this study was substantially less than the haze previously reported for the standard cross-linking procedure. CXL-associated corneal haze did not correlate with the postoperative visual or topographic outcomes 1 year after CXL.",2020,"Mean densitometry increased at 1 month (22.58 ± 3.79; P < 0.001), did not significantly change between 1 and 3 months (22.64 ± 3.83; P = 0.8), and significantly improved between 3 and 12 months postoperatively (mean6 21.59 ± 3.39; P = 0.002, mean12 20.80 ± 3.27; P = 0.002).","['patients with keratoconus', 'Fifty-nine eyes of 43 patients with keratoconus', 'Patients underwent', 'Keratoconus']","['transepithelial corneal collagen cross-linking (TECXL', 'intraoperative riboflavin', 'riboflavin', 'TECXL']","['Corneal Haze', 'corneal haze', 'CXL-associated corneal haze', 'visual acuity, pachymetry, and topography outcomes', 'postoperative time course', 'corrected distance visual acuity', 'Mean densitometry', 'preoperative and 1-year densitometry measurements', 'uncorrected distance visual acuity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}]","[{'cui': 'C0010038', 'cui_str': 'Corneal opacity'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011321', 'cui_str': 'Densitometry'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",43.0,0.0458156,"Mean densitometry increased at 1 month (22.58 ± 3.79; P < 0.001), did not significantly change between 1 and 3 months (22.64 ± 3.83; P = 0.8), and significantly improved between 3 and 12 months postoperatively (mean6 21.59 ± 3.39; P = 0.002, mean12 20.80 ± 3.27; P = 0.002).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'J Lai', 'Affiliation': 'The Cornea and Laser Eye Institute-Hersh Vision Group, CLEI Center for Keratoconus, Teaneck, NJ.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Greenstein', 'Affiliation': 'The Cornea and Laser Eye Institute-Hersh Vision Group, CLEI Center for Keratoconus, Teaneck, NJ.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Gelles', 'Affiliation': 'The Cornea and Laser Eye Institute-Hersh Vision Group, CLEI Center for Keratoconus, Teaneck, NJ.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Hersh', 'Affiliation': 'The Cornea and Laser Eye Institute-Hersh Vision Group, CLEI Center for Keratoconus, Teaneck, NJ.'}]",Cornea,['10.1097/ICO.0000000000002334']
237,31289334,The effects of exercise session timing on weight loss and components of energy balance: midwest exercise trial 2.,"BACKGROUND/OBJECTIVES


Circadian physiology has been linked to body weight regulation and obesity. To date, few studies have assessed the association between exercise timing and weight related outcomes. The aim of this secondary analysis was to explore the impact of exercise timing (i.e., 24 h clock time of exercise session) on weight loss and components of energy balance.
SUBJECTS/METHODS


Overweight/obese (BMI 25.0-39.9 kg/m 2 ), physically inactive, young adults (~51% female) completed a 10-month supervised exercise program (400 or 600 kcal/session for 5 days/week) or served as non-exercise controls (CON). Participants were categorized based on the time of day in which they completed exercise sessions (Early-Ex: >50% of sessions completed between 7:00 and 11:59 am; (n = 21), Late-Ex: >50% of sessions completed between 3:00 and 7:00 pm; (n = 25), Sporadic-Ex: <50% of sessions completed in any time category; (n = 24), and CON; (n = 18)). Body weight, energy intake (EI; digital photography), and non-exercise physical activity (NEPA; accelerometer) were assessed at baseline, 3.5, 7, and 10 months. Total daily energy expenditure (TDEE; doubly labeled water), was assessed at baseline and 10 months.
RESULTS


At month 10, weight loss was significantly greater in both Early-EX (-7.2 ± 1.2%; p < 0.001) and Sporadic-EX (- 5.5 ± 1.2%; p = 0.01) vs CON (+0.5 ± 1.0%), and Early-EX vs Late-EX (-2.1 ± 1.0%; p < 0.001). There were no between group differences for change in TDEE, EI, and non-exercise energy expenditure (P > 0.05). A significant group × time interaction (p = 0.02) was observed for NEPA (counts/min), however, after adjusting for multiple comparisons, group effects were no longer significant.
CONCLUSIONS


Despite minimal differences in components of energy balance, Early-EX lost significantly more weight compared with Late-Ex. Although the mechanisms are unclear, the timing of exercise may be important for body weight regulation.",2020,"A significant group × time interaction (p = 0.02) was observed for NEPA (counts/min), however, after adjusting for multiple comparisons, group effects were no longer significant.
","['Overweight/obese (BMI 25.0-39.9\u2009kg/m 2 ), physically inactive, young adults (~51% female']","['exercise session', 'supervised exercise program (400 or 600\u2009kcal/session for 5 days/week) or served as non-exercise controls (CON', 'CON']","['Total daily energy expenditure (TDEE; doubly labeled water', 'time interaction', 'weight loss', 'Body weight, energy intake (EI; digital photography), and non-exercise physical activity (NEPA; accelerometer', 'change in TDEE, EI, and non-exercise energy expenditure', 'weight loss and components of energy balance']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",,0.0725595,"A significant group × time interaction (p = 0.02) was observed for NEPA (counts/min), however, after adjusting for multiple comparisons, group effects were no longer significant.
","[{'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Willis', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina-Chapel Hill, Chapel Hill, NC, USA. erik.willis@unc.edu.'}, {'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Creasy', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Anschutz Medical Campus, University of Colorado Aurora, Aurora, CO, USA.'}, {'ForeName': 'Jeffery J', 'Initials': 'JJ', 'LastName': 'Honas', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Anschutz Medical Campus, University of Colorado Aurora, Aurora, CO, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, Kansas City, KS, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0409-x']
238,32286154,Between-limb asymmetry in kinetic and temporal characteristics during bilateral plyometric drop jumps from different heights.,"This study investigated the between-limb asymmetry in kinetic and temporal characteristics during bilateral plyometric drop jumps from different heights. Seventeen male basketball players performed drop jumps from 3 heights on two platforms in randomized orders. Vertical ground reaction force data were analysed with respect to the lead limb (i.e. the limb stepping off the raised platform first) and trail limb. Peak forces and loading rates of each limb were calculated. The absolute time differential between the two limbs at initial ground contact and takeoff were determined. The frequency of symmetrical landing and taking off with ""both limbs together"" were counted using 3 time windows. Results showed that the lead limb displayed higher peak forces and loading rates than the trail limb across all heights (p <.05). As drop height increased, the absolute time differentials decreased at initial ground contact (p <.001) but increased at takeoff (p =.035). The greater the preset time window, the more landings and takeoffs were classified as bilaterally symmetrical. In conclusion, higher drop heights allowed subjects to become more bilaterally symmetrical in the timing of landing but this reduction in temporal asymmetry did not accompany with any reduction in kinetic asymmetry.",2020,Results showed that the lead limb displayed higher peak forces and loading rates than the trail limb across all heights (p <.05).,['Seventeen male basketball players'],[],"['frequency of symmetrical landing and taking off with ""both limbs together', 'absolute time differentials', 'Peak forces and loading rates of each limb', 'peak forces and loading rates']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}]",[],"[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]",17.0,0.0233817,Results showed that the lead limb displayed higher peak forces and loading rates than the trail limb across all heights (p <.05).,"[{'ForeName': 'Yi Y', 'Initials': 'YY', 'LastName': 'Lim', 'Affiliation': 'Physical Education and Sports Science Academic Group, National Institute of Education, Nanyang Technological University , Singapore, Singapore.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Sterzing', 'Affiliation': 'Sports Science and Engineering Laboratory, Xtep (China) Co Ltd , Xiamen, China.'}, {'ForeName': 'Crosby J Y', 'Initials': 'CJY', 'LastName': 'Teo', 'Affiliation': 'Physical Education and Sports Science Academic Group, National Institute of Education, Nanyang Technological University , Singapore, Singapore.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Alonzo', 'Affiliation': 'Physical Education and Sports Science Academic Group, National Institute of Education, Nanyang Technological University , Singapore, Singapore.'}, {'ForeName': 'Jing W', 'Initials': 'JW', 'LastName': 'Pan', 'Affiliation': 'Physical Education and Sports Science Academic Group, National Institute of Education, Nanyang Technological University , Singapore, Singapore.'}, {'ForeName': 'Phillis S P', 'Initials': 'PSP', 'LastName': 'Teng', 'Affiliation': 'Institute for Sports Research, Nanyang Technological University , Singapore, Singapore.'}, {'ForeName': 'Pui W', 'Initials': 'PW', 'LastName': 'Kong', 'Affiliation': 'Physical Education and Sports Science Academic Group, National Institute of Education, Nanyang Technological University , Singapore, Singapore.'}]",Journal of sports sciences,['10.1080/02640414.2020.1752535']
239,32282434,Corneal higher-order aberrations after crosslinking and intrastromal corneal ring segments for keratoconus.,"PURPOSE


To assess anterior corneal higher-order aberrations (HOAs) after corneal crosslinking (CXL) and intrastromal corneal ring segments (Intacs) used adjunctively.
SETTING


Cornea and refractive surgery practice.
DESIGN


Prospective, randomized clinical trial.
METHODS


One hundred fifty-eight eyes of 150 patients were randomized into 2 groups: concurrent, Intacs and CXL during the same session (n = 81), or sequential, Intacs followed by CXL 3 months later (n = 77). Outcomes included changes in total, coma, trefoil, and spherical anterior corneal HOA 6 months after Intacs/CXL. The change in anterior corneal HOAs was correlated with the change in uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and topography indices of maximum keratometry (Kmax), maximum flattening keratometry (Kmaxflat), and inferior-superior (I-S) ratio. A subjective visual function questionnaire was also analyzed.
RESULTS


UDVA, CDVA, Kmax, I-S, and Kmaxflat all improved 6 months after treatment (UDVA = -0.22 ± 0.34, P < .001; CDVA = -0.13 ± 0.24, P < .001; Kmax = -3.1 ± 3.0D, P < .001; I-S = -4.2 ± 5.0 diopters [D], P < .001; Kmaxflat = -7.9 ± 4.0 D, P < .001). Total anterior corneal HOA, vertical coma, and horizontal coma anterior corneal HOAs significantly improved by -1.05 ± 0.93 μm (P < .001), -1.53 ± 1.18 μm (P < .001), and -0.35 ± 0.57 μm (P < .001), respectively. Spherical anterior corneal HOAs increased by 0.24 ± 0.70 μm (P < .001) at 6 months after Intacs/CXL. The change in trefoil was not statistically significant (Ptrefoil0 = .06, Ptrefoil30 = .2). There were no significant differences between the changes in anterior corneal HOAs in the sequential and same-day Intacs/CXL groups. The change in total anterior corneal HOAs was correlated with Kmax, Kmaxflat, and the I-S ratio. There was no correlation between the change in anterior corneal HOAs and the change in visual acuity or visual function survey responses.
CONCLUSIONS


Total, horizontal coma, and vertical coma anterior corneal HOAs improved after Intacs/CXL. Spherical anterior corneal HOAs increased postoperatively, and there was no change in trefoil. Improvement of anterior corneal HOAs did not correlate with visual acuity improvement or subjective visual satisfaction outcomes.",2020,"Spherical anterior corneal HOAs increased by 0.24±0.70 µm (p<0.001), 6 months after Intacs/CXL.",['158 eyes were randomized to 2 groups'],"['corneal crosslinking (CXL) and intracorneal ring segments (Intacs) used adjunctively', 'concurrent, Intacs and CXL']","['visual acuity or visual function survey responses', 'total anterior corneal HOAs', 'uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and topography indices of maximum keratometry (Kmax), maximum flattening keratometry (Kmaxflat), and inferior-superior (I-S) ratio', 'horizontal coma, and vertical coma anterior corneal HOAs', 'change in anterior corneal HOAs', 'change in trefoil', 'visual acuity improvement or subjective visual satisfaction outcomes', 'changes in total, coma, trefoil, and spherical anterior corneal HOA 6 months after Intacs/CXL', 'anterior corneal higher-order aberrations (HOAs', 'subjective visual function questionnaire', 'UDVA, CDVA, Kmax, I-S , and Kmaxflat', 'Spherical anterior corneal HOAs', 'anterior corneal HOAs', 'Total anterior corneal HOA, vertical coma, and horizontal coma anterior corneal HOAs']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1283144', 'cui_str': 'Intracorneal ring implant'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0430885', 'cui_str': 'Keratometry'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0950061', 'cui_str': 'Trefoil'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0263746', 'cui_str': 'Degenerative joint disease of hand'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1283144', 'cui_str': 'Intracorneal ring implant'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",158.0,0.0675137,"Spherical anterior corneal HOAs increased by 0.24±0.70 µm (p<0.001), 6 months after Intacs/CXL.","[{'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Greenstein', 'Affiliation': 'From the Cornea and Laser Eye Institute-Hersh Vision Group, CLEI Center for Keratoconus (Greenstein, Chung, Rosato, Gelles, Hersh), Teaneck, and the Department of Ophthalmology, Rutgers-New Jersey Medical School (Greenstein, Hersh), Newark, New Jersey, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Chung', 'Affiliation': ''}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Rosato', 'Affiliation': ''}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Gelles', 'Affiliation': ''}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Hersh', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000209']
240,32285282,"Opioid Consumption Following Breast Surgery Decreases with a Brief Educational Intervention: A Randomized, Controlled Trial.","BACKGROUND


Current rates of opioid prescribing and consumption in the United States have resulted in deleterious consequences for both patients and society. There has been a focus on opioid consumption and overprescribing, but the utility of patient education in reducing opioid consumption has only recently been explored. This randomized trial aimed to evaluate the effectiveness of a brief patient educational intervention in reducing pain and opioid consumption in patients undergoing mastectomy and breast reconstruction.
METHODS


A parallel, randomized, single-center trial of women undergoing mastectomy with immediate, implant-based breast reconstruction was completed to evaluate the utility of a patient educational instrument with information on multi-modal pain control. A questionnaire was administered postoperatively to collect data on pain control and opioid consumption.
RESULTS


Fifty participants were randomized to each group preoperatively; 46 control (92%) and 39 intervention (78%) participants completed the postoperative questionnaire. Active tobacco use was more common in the control group (p = 0.04). There was a trend towards lower pain scores in the intervention group (3.0/10, SD 1.8 vs 3.6/10, SD 1.6, p = 0.06). Both groups were prescribed a median of 32.0 5-mg oxycodone tablets postoperatively. Participants in the intervention group consumed 33% fewer opioids than the control group (16.2 tablets, SD 16.4 vs 24.3 tablets, SD 21.8, p = 0.05).
CONCLUSIONS


The use of a brief educational intervention provided at a preoperative appointment can reduce opioid consumption. We recommend the use of an educational intervention to decrease opioid consumption among breast surgery patients.",2020,"There was a trend towards lower pain scores in the intervention group (3.0/10, SD 1.8 vs 3.6/10, SD 1.6, p = 0.06).","['breast surgery patients', 'patients undergoing mastectomy and breast reconstruction', 'women undergoing', 'Fifty participants']","['patient educational instrument with information on multi-modal pain control', 'mastectomy with immediate, implant-based breast reconstruction', 'Opioid Consumption', 'educational intervention', 'patient educational intervention', 'Brief Educational Intervention']","['pain and opioid consumption', 'opioid consumption', 'postoperative questionnaire', 'lower pain scores']","[{'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",50.0,0.272624,"There was a trend towards lower pain scores in the intervention group (3.0/10, SD 1.8 vs 3.6/10, SD 1.6, p = 0.06).","[{'ForeName': 'Katie G', 'Initials': 'KG', 'LastName': 'Egan', 'Affiliation': 'Department of Plastic Surgery, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'De Souza', 'Affiliation': 'Department of Plastic Surgery, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Muenks', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Niaman', 'Initials': 'N', 'LastName': 'Nazir', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Korentager', 'Affiliation': 'Department of Plastic Surgery, University of Kansas Medical Center, Kansas City, KS, USA. rkorentager@kumc.edu.'}]",Annals of surgical oncology,['10.1245/s10434-020-08432-7']
241,32006028,Lipid-Based Nutrient Supplementation Reduces Child Anemia and Increases Micronutrient Status in Madagascar: A Multiarm Cluster-Randomized Controlled Trial.,"BACKGROUND


Iron deficiency anemia affects hundreds of millions of women and children worldwide and is associated with impaired infant outcomes. Small-quantity lipid-based nutrient supplement (LNS) have been found to reduce the prevalence of anemia and iron deficiency in some trials.
OBJECTIVES


We evaluated the effectiveness of daily LNS supplementation on child anemia and micronutrient status in Madagascar within the context of an existing, scaled-up nutrition program.
METHODS


We cluster-randomized 125 communities to (T0) a routine program with monthly growth monitoring and nutrition education; (T1) T0 + home visits for intensive nutrition counselling; (T2) T1 + LNS for children aged 6-18 mo; (T3) T2 + LNS for pregnant/lactating women; or (T4) T1 + parenting messages. Pregnant women and infants aged <12 mo were enrolled in 2014 and followed for 2 y. Child outcome measures included hemoglobin and anemia assessed using the HemoCue 301 system (n = 3561), and serum ferritin and soluble transferrin receptor as markers of iron status, retinol-binding protein as a marker of vitamin A status, and C-reactive protein and α-1 acid glycoprotein from a finger stick blood draw among a subsample (n = 387). We estimated mean difference using linear regression and prevalence ratios using modified Poisson regression accounting for the clustered design. All analyses were intention-to-treat.
RESULTS


Children in the LNS groups (T2 and T3) had ∼40% lower prevalence of anemia and iron deficiency anemia and 25% lower prevalence of iron deficiency than children in the control group (T0) (P < 0.05 for all). There were no differences in any of the biomarkers when comparing children in the T4 group with those in T0; nor were there differences between T3 and T2.
CONCLUSIONS


Our findings suggest the provision of LNS in the context of a large-scale program offers significant benefits on anemia and iron status in young children.This trial was registered at www.isrctn.com as ISRCTN14393738.",2020,"There were no differences in any of the biomarkers when comparing children in the T4 group with those in T0; nor were there differences between T3 and T2.
","['Madagascar', 'young children', 'Pregnant women and infants aged <12\xa0mo were enrolled in 2014 and followed for 2 y. Child outcome measures included hemoglobin and anemia assessed using the HemoCue 301 system (n\xa0=\xa03561), and serum ferritin and soluble transferrin receptor as markers of iron status, retinol-binding protein as a marker of vitamin A status, and C-reactive protein and α-1 acid glycoprotein from a finger stick blood draw among a subsample (n\xa0=\xa0387']","['Lipid-Based Nutrient Supplementation', 'routine program with monthly growth monitoring and nutrition education; (T1) T0\xa0+\xa0home visits for intensive nutrition counselling; (T2) T1\xa0+\xa0LNS for children aged 6-18\xa0mo; (T3) T2\xa0+\xa0LNS for pregnant/lactating women; or (T4) T1', 'daily LNS supplementation', 'Small-quantity lipid-based nutrient supplement (LNS']","['prevalence of anemia and iron deficiency anemia', 'anemia and iron status', 'prevalence of iron deficiency']","[{'cui': 'C0024443', 'cui_str': 'Malagasy Republic'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C1116139', 'cui_str': 'Transferrin receptor, soluble (substance)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1446172', 'cui_str': 'Retinol binding protein measurement (procedure)'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0457575', 'cui_str': 'Finger-prick sampling (procedure)'}, {'cui': 'C0190979', 'cui_str': 'Venesection'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C3714365', 'cui_str': 'Counseling about nutrition'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0240066', 'cui_str': 'Iron deficiency (disorder)'}]",125.0,0.234137,"There were no differences in any of the biomarkers when comparing children in the T4 group with those in T0; nor were there differences between T3 and T2.
","[{'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Stewart', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Lia C H', 'Initials': 'LCH', 'LastName': 'Fernald', 'Affiliation': 'Division of Community Health Sciences, School of Public Health, University of California Berkeley, Berkeley, CA, USA.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Weber', 'Affiliation': 'School of Community Health Sciences, University of Nevada Reno, Reno, NV, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Galasso', 'Affiliation': 'Development Research Group, The World Bank, Washington, DC, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz320']
242,31467447,"Parents of newborns in the NICU enrolled in genome sequencing research: hopeful, but not naïve.","PURPOSE


In 2014, our institution launched a randomized controlled trial (RCT) comparing rapid genome sequencing (GS) to standard clinical evaluations of infants with suspected genetic disorders. This study aimed to understand parental response to the use of GS for their newborn babies.
METHODS


Twenty-three of 128 parents whose infant had enrolled in the RCT completed a retrospective survey and interview addressing attitudes about GS and responses to receiving diagnostic information. We also collected information about participants' genetic literacy, genetic knowledge, numeracy, and symptoms of anxiety and depression.
RESULTS


The majority reported positive (13; 56.5%) or neutral 4 (4; 17.4%) feelings when approached about GS for their infant and 100% felt that GS was generally beneficial. The 12 participants who had received a unifying diagnosis for their child's symptoms described personal utility of the information. Some reported the diagnosis led to changes in medical care. Participants showed understanding of some of the psychological risks of GS. For example, 21 (91.3%) agreed or strongly agreed that genetic testing could reveal disturbing results.
CONCLUSIONS


Parents who enrolled their newborn in a RCT of GS demonstrated awareness of a psychological risk, but generally held positive beliefs about GS and perceived the benefits outweighed the risk.",2020,The majority reported positive (13; 56.5%) or neutral 4 (4; 17.4%) feelings when approached about GS for their infant and 100% felt that GS was generally beneficial.,"['infants with suspected genetic disorders', 'Twenty-three of 128 parents whose infant had enrolled in the RCT completed a retrospective survey and interview addressing attitudes about GS and responses to receiving diagnostic information', 'Parents of newborns in the NICU enrolled in genome sequencing research', ""12 participants who had received a unifying diagnosis for their child's symptoms described personal utility of the information""]",[],['psychological risks of GS'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0019247', 'cui_str': 'Hereditary Diseases'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0035168'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",[],"[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",128.0,0.0537586,The majority reported positive (13; 56.5%) or neutral 4 (4; 17.4%) feelings when approached about GS for their infant and 100% felt that GS was generally beneficial.,"[{'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Berrios', 'Affiliation': ""Center for Pediatric Genomic Medicine, Children's Mercy Kansas City, Kansas City, MO, USA. cdberrios@cmh.edu.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Koertje', 'Affiliation': ""Division of Developmental and Behavioral Sciences, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Noel-MacDonnell', 'Affiliation': 'School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Soden', 'Affiliation': ""Center for Pediatric Genomic Medicine, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lantos', 'Affiliation': 'School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.'}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-019-0644-5']
243,31858128,"Tubaramure, a Food-Assisted Maternal and Child Health and Nutrition Program in Burundi, Increased Household Food Security and Energy and Micronutrient Consumption, and Maternal and Child Dietary Diversity: A Cluster-Randomized Controlled Trial.","BACKGROUND


Food-assisted maternal and child health and nutrition programs are a widely used approach to address undernutrition. Little is known about the effects of these programs' combined household and individual food rations on household and individual food consumption. Tubaramure in Burundi targeted women and children during the first 1000 d of life, and included: 1) food rations (corn-soy blend and micronutrient-fortified vegetable oil); 2) health services strengthening and promotion of their use; and 3) behavior change communication on nutrition, hygiene, and health practices.
OBJECTIVES


The objectives were: 1) to assess Tubaramure's impact on household food consumption and food security, maternal dietary diversity, and infant and young child feeding practices; 2) to explore the role of the food rations; and 3) assess 6-8 mo impacts around 8 mo after the end of the program.
METHODS


We used a 4-arm cluster-randomized controlled repeated cross-sectional design (11,906 observations). The treatment arms received the same food ration but differed in the ration timing and duration: 1) the first 1000 d; 2) from pregnancy through 17.9 mo of age; or 3) from birth through 23.9 mo of age.
RESULTS


Tubaramure significantly (P < 0.05) improved the percentage of food secure households [from 4.5 to 7.3 percentage points (pp)], and increased household energy consumption (from 17% to 20%) and micronutrient consumption. The program had a positive effect on maternal dietary diversity (+0.4 food groups, P < 0.05) and increased the proportion of children aged 6-23.9 mo consuming ≥4 food groups (from 8.0 to 9.6 pp, P < 0.05). The effects on many outcomes were attributable to the food rations. Postprogram effects (P < 0.05) were found on household food security, maternal dietary diversity, and younger sibling's complementary feeding practices.
CONCLUSIONS


Programs such as Tubaramure have the potential to improve food security and household and individual energy and micronutrient consumption in severely resource-constrained populations, as seen in rural Burundi. This trial was registered at clinicaltrials.gov as NCT01072279.",2020,"The program had a positive effect on maternal dietary diversity (+0.4 food groups, P < 0.05) and increased the proportion of children aged 6-23.9 mo consuming ≥4 food groups (from 8.0 to 9.6 pp, P ",[],['food rations (corn-soy blend and micronutrient-fortified vegetable oil); 2) health services strengthening and promotion of their use; and 3) behavior change communication'],"['Household Food Security and Energy and Micronutrient Consumption, and Maternal and Child Dietary Diversity', 'maternal dietary diversity', 'percentage of food secure households', 'household food consumption and food security, maternal dietary diversity, and infant and young child feeding practices; 2) to explore the role of the food rations; and 3)\xa0assess 6-8', 'household energy consumption']",[],"[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0087179', 'cui_str': 'Zea'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0042438', 'cui_str': 'Vegetable Oils'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C3178753', 'cui_str': 'Food Security'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0035820', 'cui_str': 'Role'}]",,0.0796038,"The program had a positive effect on maternal dietary diversity (+0.4 food groups, P < 0.05) and increased the proportion of children aged 6-23.9 mo consuming ≥4 food groups (from 8.0 to 9.6 pp, P ","[{'ForeName': 'Jef L', 'Initials': 'JL', 'LastName': 'Leroy', 'Affiliation': 'International Food Policy Research Institute, 2033\xa0K Street NW, Washington DC 20006, USA.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'K Olney', 'Affiliation': 'International Food Policy Research Institute, 2033\xa0K Street NW, Washington DC 20006, USA.'}, {'ForeName': 'Lilia', 'Initials': 'L', 'LastName': 'Bliznashka', 'Affiliation': 'International Food Policy Research Institute, 2033\xa0K Street NW, Washington DC 20006, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Ruel', 'Affiliation': 'International Food Policy Research Institute, 2033\xa0K Street NW, Washington DC 20006, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz295']
244,32280979,"On ""Comparative Effectiveness of mHealth-Supported Exercise Compared With Exercise Alone for People With Parkinson Disease: Randomized Controlled Pilot Study."" Ellis TD, Cavanaugh JT, DeAngelis T, Hendron K, Thomas CA, Saint-Hilaire M, Pencina K, Latham NK. Phys Ther. 2019; 99:203-216.",,2020,,['People With Parkinson Disease'],['mHealth-Supported Exercise Compared With Exercise Alone'],"['Ellis TD, Cavanaugh, JT, DeAngelis, T, Hendron, K, Thomas, CA, Saint-Hilaire, M, Pencina, K, Latham, NK']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0242823', 'cui_str': 'Saints'}]",,0.0311955,,"[{'ForeName': 'Fulvio', 'Initials': 'F', 'LastName': 'Scorza', 'Affiliation': 'Disciplina de Neurociência, Universidade Federal de São Paulo/Escola Paulista de Medicina (UNIFESP/EPM), São Paulo, Brazil.'}, {'ForeName': 'Laís', 'Initials': 'L', 'LastName': 'Rodrigues', 'Affiliation': 'Disciplina de Neurociência, Universidade Federal de São Paulo/Escola Paulista de Medicina (UNIFESP/EPM).'}, {'ForeName': 'Leandro', 'Initials': 'L', 'LastName': 'Oliveira', 'Affiliation': 'Disciplina de Neurociência, Universidade Federal de São Paulo/Escola Paulista de Medicina (UNIFESP/EPM).'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Andersen', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de São Paulo/Escola Paulista de Medicina (UNIFESP/EPM).'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Tufik', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de São Paulo/Escola Paulista de Medicina (UNIFESP/EPM).'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Finsterer', 'Affiliation': 'Krankenanstalt Rudolfstiftung, Vienna, Messerli Institute, Veterinary University of Vienna, Vienna, Austria.'}]",Physical therapy,['10.1093/ptj/pzaa061']
245,32281941,Integrated Care Intervention Supported by a Mobile Health Tool for Patients Using Noninvasive Ventilation at Home: Randomized Controlled Trial.,"BACKGROUND


Home-based noninvasive ventilation has proven cost-effective. But, adherence to therapy still constitutes a common clinical problem. We hypothesized that a behavioral intervention supported by a mobile health (mHealth) app could enhance patient self-efficacy. It is widely accepted that mHealth-supported services can enhance productive interactions among the stakeholders involved in home-based respiratory therapies.
OBJECTIVE


This study aimed to measure changes in self-efficacy in patients with chronic respiratory failure due to diverse etiologies during a 3-month follow-up period after the intervention. Ancillary objectives were assessment of usability and acceptability of the mobile app as well as its potential contribution to collaborative work among stakeholders.
METHODS


A single-blind, single-center, randomized controlled trial was conducted between February 2019 and June 2019 with 67 adult patients with chronic respiratory failure undergoing home-based noninvasive ventilation. In the intervention group, a psychologist delivered a face-to-face motivational intervention. Follow-up was supported by a mobile app that allowed patients to report the number of hours of daily noninvasive ventilation use and problems with the therapy. Advice was automatically delivered by the mobile app in case of a reported problem. The control group received usual care. The primary outcome was the change in the Self Efficacy in Sleep Apnea questionnaire score. Secondary outcomes included app usability, app acceptability, continuity of care, person-centered care, and ventilatory parameters.
RESULTS


Self-efficacy was not significantly different in the intervention group after the intervention (before: mean 3.4, SD 0.6; after: mean 3.4, SD 0.5, P=.51). No changes were observed in adherence to therapy nor quality of life. Overall, the mHealth tool had a good usability score (mean 78 points) and high acceptance rate (mean score of 7.5/10 on a Likert scale). It was considered user-friendly (mean score of 8.2/10 on a Likert scale) and easy to use without assistance (mean score of 8.5/10 on a Likert scale). Patients also scored the perception of continuity of care and person-centered care as high.
CONCLUSIONS


The integrated care intervention supported by the mobile app did not improve patient self-management. However, the high acceptance of the mobile app might indicate potential for enhanced communication among stakeholders. The study identified key elements required for mHealth tools to provide effective support to collaborative work and personalized care.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03932175; https://clinicaltrials.gov/ct2/show/NCT03932175.",2020,"Self-efficacy was not significantly different in the intervention group after the intervention (before: mean 3.4, SD 0.6; after: mean 3.4, SD 0.5, P=.51).","['patients with chronic respiratory failure', 'February 2019 and June 2019 with 67 adult patients with chronic respiratory failure undergoing home-based noninvasive ventilation']","['Noninvasive Ventilation at Home', 'psychologist delivered a face-to-face motivational intervention', 'Integrated Care Intervention', 'usual care']","['change in the Self Efficacy in Sleep Apnea questionnaire score', 'adherence to therapy nor quality of life', 'app usability, app acceptability, continuity of care, person-centered care, and ventilatory parameters', 'self-efficacy', 'good usability score', 'acceptance rate', 'Self-efficacy', 'patient self-efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0264492', 'cui_str': 'Chronic respiratory failure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}]","[{'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0009853', 'cui_str': 'Continuity of Care'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",67.0,0.0949463,"Self-efficacy was not significantly different in the intervention group after the intervention (before: mean 3.4, SD 0.6; after: mean 3.4, SD 0.5, P=.51).","[{'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Baltaxe', 'Affiliation': ""Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Embid', 'Affiliation': ""Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Aumatell', 'Affiliation': ""Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.""}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Martínez', 'Affiliation': ""Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Anael', 'Initials': 'A', 'LastName': 'Barberan-Garcia', 'Affiliation': ""Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kelly', 'Affiliation': 'Advanced Digital Innovation (UK) Ltd, Salts Mill, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Eaglesham', 'Affiliation': 'Advanced Digital Innovation (UK) Ltd, Salts Mill, United Kingdom.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Herranz', 'Affiliation': ""Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Eloisa', 'Initials': 'E', 'LastName': 'Vargiu', 'Affiliation': 'Eurecat Technological Center of Catalonia, Barcelona, Spain.'}, {'ForeName': 'Josep Maria', 'Initials': 'JM', 'LastName': 'Montserrat', 'Affiliation': ""Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Roca', 'Affiliation': ""Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Cano', 'Affiliation': ""Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.""}]",JMIR mHealth and uHealth,['10.2196/16395']
246,32281943,Lifestyle Intervention Enabled by Mobile Technology on Weight Loss in Patients With Nonalcoholic Fatty Liver Disease: Randomized Controlled Trial.,"BACKGROUND


The prevalence of nonalcoholic fatty liver disease (NAFLD) reaches up to 30% in the Asian adult population, with a higher prevalence in obese patients. Weight reduction is typically recommended for patients at high risk or diagnosed with NAFLD, but is a challenge to achieve.
OBJECTIVE


We aimed to evaluate the effect of a lifestyle intervention with a mobile app on weight loss in NAFLD patients.
METHODS


This prospective randomized controlled trial included 108 adults with NAFLD confirmed by steatosis on ultrasound and a body mass index ≥23 kg/m 2  who were recruited from a fatty liver outpatient clinic. The patients were randomly allocated to either a control group (n=53) receiving standard care, consisting of dietary and lifestyle advice by a trained nurse, or an intervention group (n=55) utilizing the Nutritionist Buddy (nBuddy) mobile app in addition to receiving dietary and lifestyle advice by a dietitian. Body weight, alanine aminotransferase (ALT), aspartate aminotransferase (AST), waist circumference, and blood pressure were measured at baseline, and then at 3 and 6 months. Intention-to-treat and per-protocol analyses were used for statistical comparisons.
RESULTS


The intervention group had a 5-fold higher likelihood (relative risk 5.2, P=.003, 95% CI 1.8-15.4) of achieving ≥5% weight loss compared to the control group at 6 months. The intervention group also showed greater reductions in weight (mean 3.2, SD 4.1 kg vs mean 0.5, SD 2.9 kg; P<.001), waist circumference (mean 2.9, SD 5.0 cm vs mean -0.7, SD 4.4 cm; P<.001), systolic blood pressure (mean 12.4, SD 14.8 mmHg vs mean 2.4, SD 12.4 mmHg; P=.003), diastolic blood pressure (mean 6.8, SD 8.9 mmHg vs mean -0.9, SD 10.0 mmHg; P=.001), ALT (mean 33.5, SD 40.4 IU/L vs mean 11.5, SD 35.2 IU/L; P=.004), and AST (mean 17.4, SD 27.5 U/L vs mean 7.4, SD 17.6 IU/L, P=.03) at 6 months.
CONCLUSIONS


Lifestyle intervention enabled by a mobile app can be effective in improving anthropometric indices and liver enzymes in patients with NAFLD. This treatment modality has the potential to be extended to a larger population scale.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12617001001381; https://tinyurl.com/w9xnfmp.",2020,"The intervention group had a 5-fold higher likelihood (relative risk 5.2, P=.003, 95% CI 1.8-15.4) of achieving ≥5% weight loss compared to the control group at 6 months.","['obese patients', 'patients with NAFLD', 'NAFLD patients', 'Patients With Nonalcoholic Fatty Liver Disease', 'patients at high risk or diagnosed with NAFLD', '108 adults with NAFLD confirmed by steatosis on ultrasound and a body mass index ≥23 kg/m 2  who were recruited from a fatty liver outpatient clinic']","['Lifestyle Intervention Enabled by Mobile Technology', 'control group (n=53) receiving standard care, consisting of dietary and lifestyle advice by a trained nurse, or an intervention group (n=55) utilizing the Nutritionist Buddy (nBuddy) mobile app in addition to receiving dietary and lifestyle advice by a dietitian', 'lifestyle intervention']","['ALT', 'weight loss', 'Body weight, alanine aminotransferase (ALT), aspartate aminotransferase (AST), waist circumference, and blood pressure', 'Weight reduction', 'anthropometric indices and liver enzymes', 'Weight Loss', 'systolic blood pressure', 'diastolic blood pressure', 'waist circumference', 'reductions in weight']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0237083', 'cui_str': 'Nutritionist'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}]","[{'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",108.0,0.153139,"The intervention group had a 5-fold higher likelihood (relative risk 5.2, P=.003, 95% CI 1.8-15.4) of achieving ≥5% weight loss compared to the control group at 6 months.","[{'ForeName': 'Su Lin', 'Initials': 'SL', 'LastName': 'Lim', 'Affiliation': 'Dietetics Department, National University Hospital, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Jolyn', 'Initials': 'J', 'LastName': 'Johal', 'Affiliation': 'Dietetics Department, National University Hospital, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Kai Wen', 'Initials': 'KW', 'LastName': 'Ong', 'Affiliation': 'Dietetics Department, National University Hospital, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Chad Yixian', 'Initials': 'CY', 'LastName': 'Han', 'Affiliation': 'Dietetics Department, National University Hospital, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Yiong Huak', 'Initials': 'YH', 'LastName': 'Chan', 'Affiliation': 'Biostatistics Unit, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Yin Mei', 'Initials': 'YM', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, Gastroenterology and Hepatology, National University Hospital, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Wai Mun', 'Initials': 'WM', 'LastName': 'Loo', 'Affiliation': 'Department of Medicine, Gastroenterology and Hepatology, National University Hospital, National University Health System, Singapore, Singapore.'}]",JMIR mHealth and uHealth,['10.2196/14802']
247,31237191,The effect of cannabidiol (CBD) on low-frequency activity and functional connectivity in the brain of adults with and without autism spectrum disorder (ASD).,"BACKGROUND


The potential benefits of cannabis and its major non-intoxicating component cannabidiol (CBD) are attracting attention, including as a potential treatment in neurodevelopmental disorders such as autism spectrum disorder (ASD). However, the neural action of CBD, and its relevance to ASD, remains unclear. We and others have previously shown that response to drug challenge can be measured using functional magnetic resonance imaging (fMRI), but that pharmacological responsivity is atypical in ASD.
AIMS


We hypothesized that there would be a (different) fMRI response to CBD in ASD.
METHODS


To test this, task-free fMRI was acquired in 34 healthy men (half with ASD) following oral administration of 600 mg CBD or matched placebo (random order; double-blind administration). The 'fractional amplitude of low-frequency fluctuations' (fALFF) was measured across the whole brain, and, where CBD significantly altered fALFF, we tested if functional connectivity (FC) of those regions was also affected by CBD.
RESULTS


CBD significantly increased fALFF in the cerebellar vermis and the right fusiform gyrus. However, post-hoc within-group analyses revealed that this effect was primarily driven by the ASD group, with no significant change in controls. Within the ASD group only, CBD also significantly altered vermal FC with several of its subcortical (striatal) and cortical targets, but did not affect fusiform FC with other regions in either group.
CONCLUSION


Our results suggest that, especially in ASD, CBD alters regional fALFF and FC in/between regions consistently implicated in ASD. Future studies should examine if this affects the complex behaviours these regions modulate.",2019,"RESULTS


CBD significantly increased fALFF in the cerebellar vermis and the right fusiform gyrus.","['adults with and without autism spectrum disorder (ASD', '34 healthy men (half with ASD) following oral administration of 600 mg CBD or matched']","['cannabidiol (CBD', 'placebo']","['fALFF', ""fractional amplitude of low-frequency fluctuations' (fALFF""]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0001563', 'cui_str': 'Drug Administration, Oral'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}]",34.0,0.0979802,"RESULTS


CBD significantly increased fALFF in the cerebellar vermis and the right fusiform gyrus.","[{'ForeName': 'Charlotte M', 'Initials': 'CM', 'LastName': 'Pretzsch', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Bogdan', 'Initials': 'B', 'LastName': 'Voinescu', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Mendez', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wichers', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ajram', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Glynis', 'Initials': 'G', 'LastName': 'Ivin', 'Affiliation': 'South London and Maudsley NHS Foundation Trust Pharmacy, London, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Heasman', 'Affiliation': 'South London and Maudsley NHS Foundation Trust Pharmacy, London, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': ""Department of Neuroimaging Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Declan Gm', 'Initials': 'DG', 'LastName': 'Murphy', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Daly', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Gráinne M', 'Initials': 'GM', 'LastName': 'McAlonan', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881119858306']
248,31407943,Developing a phone-based measure of impairment after acute oral ∆ 9 -tetrahydrocannabinol.,"BACKGROUND


Acute consumption of cannabis or its primary psychoactive ingredient ∆ 9 -tetrahydrocannabinol has been shown to impair memory, reaction time, time perception, and attention. However, it is difficult to measure these impairments in a brief test that can be used in a non-laboratory setting.
AIMS


We aim to develop and validate a prototype for a mobile phone application to measure ∆ 9 -tetrahydrocannabinol-induced cognitive impairment.
METHODS


We conducted two double-blind, within-subjects studies examining impairments after oral doses of ∆ 9 -tetrahydrocannabinol (0, 7.5, 15 mg) using both standardized computer-based tasks and our novel phone-based tasks. The tasks measured cognitive speed, reaction time, fine motor ability, and working memory and, in the second study, time perception. Study 1 ( n =24) provided initial data, and Study 2 ( n =24) was designed to refine the measures. In both studies, healthy non-daily cannabis users participated in three four-hour experimental sessions in which they received capsules containing ∆ 9 -tetrahydrocannabinol (7.5, 15 mg) or placebo. Subjective and cardiovascular measures were obtained at regular intervals, and at the time of peak drug effect subjects completed both standardized, computer-based and brief, phone-based tasks.
RESULTS


∆ 9 -Tetrahydrocannabinol-induced impairment was detected on most of the computer tasks, but was not evident on most of the phone tasks.
CONCLUSIONS


The phone tasks were brief, to facilitate use in a non-laboratory setting, but it is likely that this made them less sensitive to the impairing effects of ∆ 9 -tetrahydrocannabinol. These findings confirm that ∆ 9 -tetrahydrocannabinol impairs performance on several tasks at two recreationally relevant doses, but raises question about the feasibility of designing a phone application as a sensitive field sobriety test for cannabis.",2019,"9 -tetrahydrocannabinol has been shown to impair memory, reaction time, time perception, and attention.",['healthy non-daily cannabis users'],"['placebo', '∆ 9 -tetrahydrocannabinol (0, 7.5, 15 mg) using both standardized computer-based tasks and our novel phone-based tasks']","['Subjective and cardiovascular measures', 'cognitive speed, reaction time, fine motor ability, and working memory and, in the second study, time perception']","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0199659', 'cui_str': 'Cardiovascular measure'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0040226', 'cui_str': 'Time Perception'}]",,0.048469,"9 -tetrahydrocannabinol has been shown to impair memory, reaction time, time perception, and attention.","[{'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Pabon', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881119862533']
249,31542980,The impacts of actual and perceived nicotine administration on insula functional connectivity with the anterior cingulate cortex and nucleus accumbens.,"BACKGROUND


Changes in resting state functional connectivity between the insula and dorsal anterior cingulate cortex as well as between the insula and nucleus accumbens have been linked to nicotine withdrawal and/or administration. However, because many of nicotine's effects in humans appear to depend, at least in part, on the belief that nicotine has been administered, the relative contribution of nicotine's pharmacological actions to such effects requires clarification.
AIMS


The purpose of this study was to examine the impacts of perceived and actual nicotine administration on neural responses.
METHODS


Twenty-six smokers were randomly assigned to receive either a nicotine inhaler (4 mg deliverable) or a nicotine-free inhaler across two sessions. Inhaler content instructions (told nicotine vs told nicotine-free) differed across sessions. Resting state functional connectivity between sub-regions of the insula and the dorsal anterior cingulate cortex and nucleus accumbens was measured using magnetic resonance imaging before and after inhaler administration.
RESULTS


Both actual and perceived nicotine administration independently altered resting state functional connectivity between the anterior insula and the dorsal anterior cingulate cortex, with actual administration being associated with decreased resting state functional connectivity, and perceived administration with increased resting state functional connectivity. Actual nicotine administration also contralaterally reduced resting state functional connectivity between the anterior insula and nucleus accumbens, while reductions in resting state functional connectivity between the mid-insula and right nucleus accumbens were observed when nicotine was administered unexpectedly. Changes in resting state functional connectivity associated with actual or perceived nicotine administration were unrelated to changes in subjective withdrawal and craving. Changes in withdrawal and craving were however independently associated with resting state functional connectivity between the nucleus accumbens and insula.
CONCLUSIONS


Our findings highlight the importance of considering non-pharmacological factors when examining drug mechanisms of action.",2019,"RESULTS


Both actual and perceived nicotine administration independently altered resting state functional connectivity between the anterior insula and the dorsal anterior cingulate cortex, with actual administration being associated with decreased resting state functional connectivity, and perceived administration with increased resting state functional connectivity.",['Twenty-six smokers'],"['nicotine inhaler (4 mg deliverable) or a nicotine-free inhaler across two sessions', 'nicotine']","['withdrawal and craving', 'resting state functional connectivity', 'subjective withdrawal and craving', 'resting state functional connectivity, and perceived administration with increased resting state functional connectivity']","[{'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0814019', 'cui_str': 'Nicotine inhaler'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",26.0,0.0265963,"RESULTS


Both actual and perceived nicotine administration independently altered resting state functional connectivity between the anterior insula and the dorsal anterior cingulate cortex, with actual administration being associated with decreased resting state functional connectivity, and perceived administration with increased resting state functional connectivity.","[{'ForeName': 'Robin N', 'Initials': 'RN', 'LastName': 'Perry', 'Affiliation': 'Department of Psychology and Neuroscience, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Hera E', 'Initials': 'HE', 'LastName': 'Schlagintweit', 'Affiliation': 'Department of Psychology and Neuroscience, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Darredeau', 'Affiliation': 'Department of Psychology and Neuroscience, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Helmick', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Aaron J', 'Initials': 'AJ', 'LastName': 'Newman', 'Affiliation': 'Department of Psychology and Neuroscience, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Kimberley P', 'Initials': 'KP', 'LastName': 'Good', 'Affiliation': 'Department of Psychology and Neuroscience, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Barrett', 'Affiliation': 'Department of Psychology and Neuroscience, Dalhousie University, Halifax, NS, Canada.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881119872205']
250,31618560,"Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes.","BACKGROUND


Closed-loop systems that automate insulin delivery may improve glycemic outcomes in patients with type 1 diabetes.
METHODS


In this 6-month randomized, multicenter trial, patients with type 1 diabetes were assigned in a 2:1 ratio to receive treatment with a closed-loop system (closed-loop group) or a sensor-augmented pump (control group). The primary outcome was the percentage of time that the blood glucose level was within the target range of 70 to 180 mg per deciliter (3.9 to 10.0 mmol per liter), as measured by continuous glucose monitoring.
RESULTS


A total of 168 patients underwent randomization; 112 were assigned to the closed-loop group, and 56 were assigned to the control group. The age range of the patients was 14 to 71 years, and the glycated hemoglobin level ranged from 5.4 to 10.6%. All 168 patients completed the trial. The mean (±SD) percentage of time that the glucose level was within the target range increased in the closed-loop group from 61±17% at baseline to 71±12% during the 6 months and remained unchanged at 59±14% in the control group (mean adjusted difference, 11 percentage points; 95% confidence interval [CI], 9 to 14; P<0.001). The results with regard to the main secondary outcomes (percentage of time that the glucose level was >180 mg per deciliter, mean glucose level, glycated hemoglobin level, and percentage of time that the glucose level was <70 mg per deciliter or <54 mg per deciliter [3.0 mmol per liter]) all met the prespecified hierarchical criterion for significance, favoring the closed-loop system. The mean difference (closed loop minus control) in the percentage of time that the blood glucose level was lower than 70 mg per deciliter was -0.88 percentage points (95% CI, -1.19 to -0.57; P<0.001). The mean adjusted difference in glycated hemoglobin level after 6 months was -0.33 percentage points (95% CI, -0.53 to -0.13; P = 0.001). In the closed-loop group, the median percentage of time that the system was in closed-loop mode was 90% over 6 months. No serious hypoglycemic events occurred in either group; one episode of diabetic ketoacidosis occurred in the closed-loop group.
CONCLUSIONS


In this 6-month trial involving patients with type 1 diabetes, the use of a closed-loop system was associated with a greater percentage of time spent in a target glycemic range than the use of a sensor-augmented insulin pump. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases; iDCL ClinicalTrials.gov number, NCT03563313.).",2019,"No serious hypoglycemic events occurred in either group; one episode of diabetic ketoacidosis occurred in the closed-loop group.
","['168 patients underwent randomization; 112', 'patients with type 1 diabetes, the use of a closed-loop system was associated with a greater percentage of time spent in a target glycemic range than the use of a sensor-augmented insulin pump', 'Type 1 Diabetes', 'All 168 patients completed the trial', 'patients with type 1 diabetes']","['closed-loop system (closed-loop group) or a sensor-augmented pump (control group', 'Closed-Loop Control']","['mean (±SD) percentage of time that the glucose level', 'percentage of time that the blood glucose level', 'serious hypoglycemic events', 'median percentage of time that the system', 'mean glucose level, glycated hemoglobin level, and percentage of time that the glucose level', 'glycemic outcomes', 'diabetic ketoacidosis', 'glycated hemoglobin level']","[{'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011880', 'cui_str': 'Ketosis, Diabetic'}]",112.0,0.100721,"No serious hypoglycemic events occurred in either group; one episode of diabetic ketoacidosis occurred in the closed-loop group.
","[{'ForeName': 'Sue A', 'Initials': 'SA', 'LastName': 'Brown', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (S.A.B., B.P.K., S.M.A.); the Jaeb Center for Health Research, Tampa, FL (D.R., J.W.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B., L.E.), and the Sansum Diabetes Research Institute, Santa Barbara (J.E.P., M.C.) - both in California; the Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN (Y.C.K., V.D.); the Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston (L.M.L., E.I.), and the Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge (E.D., F.J.D.) - both in Massachusetts; the Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York (C.J.L., D.W.L.); and the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.).'}, {'ForeName': 'Boris P', 'Initials': 'BP', 'LastName': 'Kovatchev', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (S.A.B., B.P.K., S.M.A.); the Jaeb Center for Health Research, Tampa, FL (D.R., J.W.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B., L.E.), and the Sansum Diabetes Research Institute, Santa Barbara (J.E.P., M.C.) - both in California; the Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN (Y.C.K., V.D.); the Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston (L.M.L., E.I.), and the Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge (E.D., F.J.D.) - both in Massachusetts; the Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York (C.J.L., D.W.L.); and the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.).'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Raghinaru', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (S.A.B., B.P.K., S.M.A.); the Jaeb Center for Health Research, Tampa, FL (D.R., J.W.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B., L.E.), and the Sansum Diabetes Research Institute, Santa Barbara (J.E.P., M.C.) - both in California; the Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN (Y.C.K., V.D.); the Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston (L.M.L., E.I.), and the Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge (E.D., F.J.D.) - both in Massachusetts; the Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York (C.J.L., D.W.L.); and the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.).'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Lum', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (S.A.B., B.P.K., S.M.A.); the Jaeb Center for Health Research, Tampa, FL (D.R., J.W.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B., L.E.), and the Sansum Diabetes Research Institute, Santa Barbara (J.E.P., M.C.) - both in California; the Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN (Y.C.K., V.D.); the Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston (L.M.L., E.I.), and the Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge (E.D., F.J.D.) - both in Massachusetts; the Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York (C.J.L., D.W.L.); and the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.).'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Buckingham', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (S.A.B., B.P.K., S.M.A.); the Jaeb Center for Health Research, Tampa, FL (D.R., J.W.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B., L.E.), and the Sansum Diabetes Research Institute, Santa Barbara (J.E.P., M.C.) - both in California; the Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN (Y.C.K., V.D.); the Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston (L.M.L., E.I.), and the Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge (E.D., F.J.D.) - both in Massachusetts; the Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York (C.J.L., D.W.L.); and the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.).'}, {'ForeName': 'Yogish C', 'Initials': 'YC', 'LastName': 'Kudva', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (S.A.B., B.P.K., S.M.A.); the Jaeb Center for Health Research, Tampa, FL (D.R., J.W.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B., L.E.), and the Sansum Diabetes Research Institute, Santa Barbara (J.E.P., M.C.) - both in California; the Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN (Y.C.K., V.D.); the Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston (L.M.L., E.I.), and the Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge (E.D., F.J.D.) - both in Massachusetts; the Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York (C.J.L., D.W.L.); and the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.).'}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Laffel', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (S.A.B., B.P.K., S.M.A.); the Jaeb Center for Health Research, Tampa, FL (D.R., J.W.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B., L.E.), and the Sansum Diabetes Research Institute, Santa Barbara (J.E.P., M.C.) - both in California; the Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN (Y.C.K., V.D.); the Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston (L.M.L., E.I.), and the Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge (E.D., F.J.D.) - both in Massachusetts; the Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York (C.J.L., D.W.L.); and the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.).'}, {'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Levy', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (S.A.B., B.P.K., S.M.A.); the Jaeb Center for Health Research, Tampa, FL (D.R., J.W.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B., L.E.), and the Sansum Diabetes Research Institute, Santa Barbara (J.E.P., M.C.) - both in California; the Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN (Y.C.K., V.D.); the Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston (L.M.L., E.I.), and the Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge (E.D., F.J.D.) - both in Massachusetts; the Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York (C.J.L., D.W.L.); and the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.).'}, {'ForeName': 'Jordan E', 'Initials': 'JE', 'LastName': 'Pinsker', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (S.A.B., B.P.K., S.M.A.); the Jaeb Center for Health Research, Tampa, FL (D.R., J.W.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B., L.E.), and the Sansum Diabetes Research Institute, Santa Barbara (J.E.P., M.C.) - both in California; the Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN (Y.C.K., V.D.); the Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston (L.M.L., E.I.), and the Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge (E.D., F.J.D.) - both in Massachusetts; the Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York (C.J.L., D.W.L.); and the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.).'}, {'ForeName': 'R Paul', 'Initials': 'RP', 'LastName': 'Wadwa', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (S.A.B., B.P.K., S.M.A.); the Jaeb Center for Health Research, Tampa, FL (D.R., J.W.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B., L.E.), and the Sansum Diabetes Research Institute, Santa Barbara (J.E.P., M.C.) - both in California; the Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN (Y.C.K., V.D.); the Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston (L.M.L., E.I.), and the Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge (E.D., F.J.D.) - both in Massachusetts; the Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York (C.J.L., D.W.L.); and the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.).'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Dassau', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (S.A.B., B.P.K., S.M.A.); the Jaeb Center for Health Research, Tampa, FL (D.R., J.W.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B., L.E.), and the Sansum Diabetes Research Institute, Santa Barbara (J.E.P., M.C.) - both in California; the Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN (Y.C.K., V.D.); the Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston (L.M.L., E.I.), and the Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge (E.D., F.J.D.) - both in Massachusetts; the Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York (C.J.L., D.W.L.); and the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.).'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Doyle', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (S.A.B., B.P.K., S.M.A.); the Jaeb Center for Health Research, Tampa, FL (D.R., J.W.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B., L.E.), and the Sansum Diabetes Research Institute, Santa Barbara (J.E.P., M.C.) - both in California; the Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN (Y.C.K., V.D.); the Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston (L.M.L., E.I.), and the Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge (E.D., F.J.D.) - both in Massachusetts; the Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York (C.J.L., D.W.L.); and the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.).'}, {'ForeName': 'Stacey M', 'Initials': 'SM', 'LastName': 'Anderson', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (S.A.B., B.P.K., S.M.A.); the Jaeb Center for Health Research, Tampa, FL (D.R., J.W.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B., L.E.), and the Sansum Diabetes Research Institute, Santa Barbara (J.E.P., M.C.) - both in California; the Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN (Y.C.K., V.D.); the Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston (L.M.L., E.I.), and the Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge (E.D., F.J.D.) - both in Massachusetts; the Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York (C.J.L., D.W.L.); and the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.).'}, {'ForeName': 'Mei Mei', 'Initials': 'MM', 'LastName': 'Church', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (S.A.B., B.P.K., S.M.A.); the Jaeb Center for Health Research, Tampa, FL (D.R., J.W.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B., L.E.), and the Sansum Diabetes Research Institute, Santa Barbara (J.E.P., M.C.) - both in California; the Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN (Y.C.K., V.D.); the Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston (L.M.L., E.I.), and the Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge (E.D., F.J.D.) - both in Massachusetts; the Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York (C.J.L., D.W.L.); and the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.).'}, {'ForeName': 'Vikash', 'Initials': 'V', 'LastName': 'Dadlani', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (S.A.B., B.P.K., S.M.A.); the Jaeb Center for Health Research, Tampa, FL (D.R., J.W.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B., L.E.), and the Sansum Diabetes Research Institute, Santa Barbara (J.E.P., M.C.) - both in California; the Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN (Y.C.K., V.D.); the Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston (L.M.L., E.I.), and the Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge (E.D., F.J.D.) - both in Massachusetts; the Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York (C.J.L., D.W.L.); and the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.).'}, {'ForeName': 'Laya', 'Initials': 'L', 'LastName': 'Ekhlaspour', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (S.A.B., B.P.K., S.M.A.); the Jaeb Center for Health Research, Tampa, FL (D.R., J.W.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B., L.E.), and the Sansum Diabetes Research Institute, Santa Barbara (J.E.P., M.C.) - both in California; the Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN (Y.C.K., V.D.); the Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston (L.M.L., E.I.), and the Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge (E.D., F.J.D.) - both in Massachusetts; the Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York (C.J.L., D.W.L.); and the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.).'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Forlenza', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (S.A.B., B.P.K., S.M.A.); the Jaeb Center for Health Research, Tampa, FL (D.R., J.W.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B., L.E.), and the Sansum Diabetes Research Institute, Santa Barbara (J.E.P., M.C.) - both in California; the Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN (Y.C.K., V.D.); the Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston (L.M.L., E.I.), and the Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge (E.D., F.J.D.) - both in Massachusetts; the Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York (C.J.L., D.W.L.); and the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.).'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Isganaitis', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (S.A.B., B.P.K., S.M.A.); the Jaeb Center for Health Research, Tampa, FL (D.R., J.W.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B., L.E.), and the Sansum Diabetes Research Institute, Santa Barbara (J.E.P., M.C.) - both in California; the Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN (Y.C.K., V.D.); the Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston (L.M.L., E.I.), and the Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge (E.D., F.J.D.) - both in Massachusetts; the Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York (C.J.L., D.W.L.); and the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.).'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Lam', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (S.A.B., B.P.K., S.M.A.); the Jaeb Center for Health Research, Tampa, FL (D.R., J.W.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B., L.E.), and the Sansum Diabetes Research Institute, Santa Barbara (J.E.P., M.C.) - both in California; the Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN (Y.C.K., V.D.); the Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston (L.M.L., E.I.), and the Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge (E.D., F.J.D.) - both in Massachusetts; the Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York (C.J.L., D.W.L.); and the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.).'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Kollman', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (S.A.B., B.P.K., S.M.A.); the Jaeb Center for Health Research, Tampa, FL (D.R., J.W.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B., L.E.), and the Sansum Diabetes Research Institute, Santa Barbara (J.E.P., M.C.) - both in California; the Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN (Y.C.K., V.D.); the Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston (L.M.L., E.I.), and the Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge (E.D., F.J.D.) - both in Massachusetts; the Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York (C.J.L., D.W.L.); and the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.).'}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (S.A.B., B.P.K., S.M.A.); the Jaeb Center for Health Research, Tampa, FL (D.R., J.W.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B., L.E.), and the Sansum Diabetes Research Institute, Santa Barbara (J.E.P., M.C.) - both in California; the Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN (Y.C.K., V.D.); the Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston (L.M.L., E.I.), and the Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge (E.D., F.J.D.) - both in Massachusetts; the Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York (C.J.L., D.W.L.); and the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1907863']
251,31024557,"Poly-ICLC, a TLR3 Agonist, Induces Transient Innate Immune Responses in Patients With Treated HIV-Infection: A Randomized Double-Blinded Placebo Controlled Trial.","Objective:  Toll-like receptor-3 agonist Poly-ICLC has been known to activate immune cells and induce HIV replication in pre-clinical experiments. In this study we investigated if Poly-ICLC could be used for disrupting HIV latency while simultaneously enhancing innate immune responses.  Design:  This was a randomized, placebo-controlled, double-blinded trial in aviremic, cART-treated HIV-infected subjects. Participants ( n  = 15) were randomized 3:1 to receive two consecutive daily doses of Poly-ICLC (1.4 mg subcutaneously) vs. placebo. Subjects were observed for adverse events, immune activation, and viral replication.  Methods:  Besides primary outcomes of safety and tolerability, several longitudinal immune parameters were evaluated including immune cell phenotype and function via flowcytometry, ELISA, and transcriptional profiling. PCR assays for plasma HIV-1 RNA, CD4 +  T cell-associated HIV-1 RNA, and proviral DNA were performed to measure HIV reservoirs and latency.  Results:  Poly-ICLC was overall safe and well-tolerated. Poly-ICLC-related adverse events were Grade 1/2, with the exception of one Grade 3 neutropenia which was short-lived. Mild Injection site reactions were observed in nearly all participants in the Poly-ICLC arm. Transcriptional analyses revealed upregulation of innate immune pathways in PBMCs following Poly-ICLC treatment, including strong interferon signaling accompanied by transient increases in circulating IP-10 (CXCL10) levels. These responses generally peaked by 24-48 h after the first injection and returned to baseline by day 8. CD4 +  T cell number and phenotype were unchanged, plasma viral control was maintained and no significant effect on HIV reservoirs was observed.  Conclusions:  These finding suggest that Poly-ICLC could be safely used for inducing transient innate immune responses in treated HIV +  subjects indicating promise as an adjuvant for HIV therapeutic vaccines.  Trial Registration:  www.ClinicalTrials.gov, identifier: NCT02071095.",2019,"CD4 +  T cell number and phenotype were unchanged, plasma viral control was maintained and no significant effect on HIV reservoirs was observed.  ","['aviremic, cART-treated HIV-infected subjects', 'Participants ( n  = 15', 'Patients With Treated HIV-Infection']","['Poly-ICLC', 'Placebo', 'placebo', 'Toll-like receptor-3 agonist Poly-ICLC']","['immune cell phenotype and function via flowcytometry, ELISA, and transcriptional profiling', 'safety and tolerability, several longitudinal immune parameters', 'PCR assays for plasma HIV-1 RNA, CD4 +  T cell-associated HIV-1 RNA, and proviral DNA', 'overall safe and well-tolerated', 'adverse events, immune activation, and viral replication', 'plasma viral control', 'HIV reservoirs', 'Mild Injection site reactions', 'circulating IP-10 (CXCL10) levels', 'CD4 +  T cell number and phenotype']","[{'cui': 'C0179636', 'cui_str': 'Cart, device (physical object)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}]","[{'cui': 'C0071359', 'cui_str': 'polyriboinosinic-polyribocytidylic acid-polylysine carboxymethylcellulose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1534866', 'cui_str': 'Toll-Like Receptor 3'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0427385', 'cui_str': 'Cell phenotype determination'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0442537', 'cui_str': 'Reservoir (environment)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}]",15.0,0.519423,"CD4 +  T cell number and phenotype were unchanged, plasma viral control was maintained and no significant effect on HIV reservoirs was observed.  ","[{'ForeName': 'Mansi', 'Initials': 'M', 'LastName': 'Saxena', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Sabado', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'La Mar', 'Affiliation': 'Aaron Diamond AIDS Research Center, Rockefeller University, New York, NY, United States.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Mohri', 'Affiliation': 'Aaron Diamond AIDS Research Center, Rockefeller University, New York, NY, United States.'}, {'ForeName': 'Andres M', 'Initials': 'AM', 'LastName': 'Salazar', 'Affiliation': 'Oncovir, Inc., Washington, DC, United States.'}, {'ForeName': 'Hanqing', 'Initials': 'H', 'LastName': 'Dong', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Correa Da Rosa', 'Affiliation': 'Laboratory of Investigative Dermatology, The Rockefeller University, New York, NY, United States.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Markowitz', 'Affiliation': 'Aaron Diamond AIDS Research Center, Rockefeller University, New York, NY, United States.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Bhardwaj', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}]",Frontiers in immunology,['10.3389/fimmu.2019.00725']
252,31037449,"Efficacy and safety of hangeshashinto for treatment of GERD refractory to proton pump inhibitors : Usual dose proton pump inhibitors plus hangeshashinto versus double-dose proton pump inhibitors: randomized, multicenter open label exploratory study.","BACKGROUND


Proton pump inhibitor (PPI)-refractory gastroesophageal reflux disease (GERD) leads to a clinical decline in the quality of life (QOL). Therefore, new treatment options are needed. We performed a multicenter, randomized, parallel-group exploratory trial to determine the efficacy of hangeshashinto (HST) in patients with PPI-refractory GERD.
METHODS


We enrolled 78 patients with PPI-refractory GERD for standard PPI regimens for at least 4 weeks and randomly assigned patients to receive either a combination of usual dose of rabeprazole (10 mg/day) + HST (7.5 g/day; HST group) or a double dose of rabeprazole (20 mg/day; double-dose PPI group). The primary end points were the extent of improvement in FSSG (Frequency Scale for the Symptoms of GERD) score and the change over time in FSSG score.
RESULTS


There was no significant difference in terms of the improvement degree of the FSSG score between the two groups. Although the total FSSG score and reflux syndrome score decreased significantly for both groups over time (p < 0.001), the acid-related dyspepsia (ARD) score decreased significantly in the HST group from 1 week after drug administration (p < 0.05), indicating an improvement in the condition earlier than in the double-dose PPI group. Moreover, in examinations concerning BMI and age, the HST group had a significantly higher improvement degree of ARD score in patients with BMI < 22 (p < 0.05) and aged < 65 years (p < 0.05) than the double-dose PPI group.
CONCLUSIONS


HST may be beneficial for patients with PPI-refractory GERD, particularly in non-obese and non-elderly patients with dyspepsia symptoms.",2019,"Although the total FSSG score and reflux syndrome score decreased significantly for both groups over time (p < 0.001), the acid-related dyspepsia (ARD) score decreased significantly in the HST group from 1 week after drug administration (p < 0.05), indicating an improvement in the condition earlier than in the double-dose PPI group.","['patients with PPI-refractory GERD', '78 patients with PPI-refractory GERD for standard PPI regimens for at least 4\xa0weeks and randomly assigned patients to']","['hangeshashinto', 'rabeprazole', 'HST', 'receive either a combination of usual dose of rabeprazole (10\xa0mg/day)\u2009+\u2009HST', 'hangeshashinto (HST']","['acid-related dyspepsia (ARD) score', 'FSSG (Frequency Scale for the Symptoms of GERD) score and the change over time in FSSG score', 'total FSSG score and reflux syndrome score', 'Efficacy and safety', 'ARD score', 'FSSG score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0378482', 'cui_str': 'rabeprazole'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}]","[{'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}]",78.0,0.066715,"Although the total FSSG score and reflux syndrome score decreased significantly for both groups over time (p < 0.001), the acid-related dyspepsia (ARD) score decreased significantly in the HST group from 1 week after drug administration (p < 0.05), indicating an improvement in the condition earlier than in the double-dose PPI group.","[{'ForeName': 'Toshihisa', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Osaka Medical College Hospital Endoscopy Center, 2-7 Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan. in2097@osaka-med.ac.jp.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Hongo', 'Affiliation': 'Fujita Gastroenterology Hospital, Osaka, Japan.'}, {'ForeName': 'Tsuguhiro', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Fujita Gastroenterology Hospital, Osaka, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Kojima', 'Affiliation': 'Osaka Medical College Hospital Endoscopy Center, 2-7 Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Harada', 'Affiliation': 'Department of Internal Medicine II, Osaka Medical College Hospital, Osaka, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Ota', 'Affiliation': 'Department of Internal Medicine II, Osaka Medical College Hospital, Osaka, Japan.'}, {'ForeName': 'Nozomi', 'Initials': 'N', 'LastName': 'Takeuchi', 'Affiliation': 'Settsu Clinic, Osaka, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Noguchi', 'Affiliation': 'Noguchi Clinic, Osaka, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Inoue Gastroenterology Clinic, Osaka, Japan.'}, {'ForeName': 'Mitsuyuki', 'Initials': 'M', 'LastName': 'Murano', 'Affiliation': 'Murano Clinic, Osaka, Japan.'}, {'ForeName': 'Kazuhide', 'Initials': 'K', 'LastName': 'Higuchi', 'Affiliation': 'Department of Internal Medicine II, Osaka Medical College Hospital, Osaka, Japan.'}]",Journal of gastroenterology,['10.1007/s00535-019-01588-4']
253,32278779,"Association of Guideline-Recommended COPD Inhaler Regimens With Mortality, Respiratory Exacerbations, and Quality of Life: A Secondary Analysis of the Long-Term Oxygen Treatment Trial.","BACKGROUND


Although inhaled therapy reduces exacerbations among patients with COPD, the effectiveness of providing inhaled treatment per risk stratification models remains unclear.
RESEARCH QUESTION


Are inhaled regimens that align with the 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy associated with clinically important outcomes?
STUDY DESIGN AND METHODS


We conducted secondary analyses of Long-term Oxygen Treatment Trial (LOTT) data. The trial enrolled patients with COPD with moderate resting or exertional hypoxemia between 2009 and 2015. Our exposure was the patient-reported inhaled regimen at enrollment, categorized as either aligning with, undertreating, or potentially overtreating per the 2017 GOLD strategy. Our primary composite outcome was time to death or first hospitalization for COPD. Additional outcomes included individual components of the composite outcome and time to first exacerbation. We generated multivariable Cox proportional hazard models across strata of GOLD-predicted exacerbation risk (high vs low) to estimate between-group hazard ratios for time to event outcomes. We adjusted models a priori for potential confounders, clustered by site.
RESULTS


The trial enrolled 738 patients (73.4% men; mean age, 68.8 years). Of the patients, 571 (77.4%) were low risk for future exacerbations. Of the patients, 233 (31.6%) reported regimens aligning with GOLD recommendations; most regimens (54.1%) potentially overtreated. During a 2.3-year median follow-up, 332 patients (44.9%) experienced the composite outcome. We found no difference in time to composite outcome or death among patients reporting regimens aligning with recommendations compared with undertreated patients. Among patients at low risk, potential overtreatment was associated with higher exacerbation risk (hazard ratio, 1.42; 95% CI, 1.09-1.87), whereas inhaled corticosteroid treatment was associated with 64% higher risk of pneumonia (incidence rate ratio, 1.64; 95% CI, 1.01-2.66).
INTERPRETATION


Among patients with COPD with moderate hypoxemia, we found no difference in clinical outcomes between inhaled regimens aligning with the 2017 GOLD strategy compared with those that were undertreated. These findings suggest the need to reevaluate the effectiveness of risk stratification model-based inhaled treatment strategies.",2020,We found no difference in time-to composite outcome or death among patients reporting regimens aligning with recommendations compared to undertreated patients.,"['COPD patients with moderate hypoxemia', 'enrolled COPD patients with moderate resting or exertional hypoxemia between 2009-2015', 'and Methods', 'COPD patients', '571 patients (77.4%) were low-risk for future exacerbations', '738 patients; 73.4% were male with mean age 68.8 years']",[],"['individual components of the composite outcome and time-to first exacerbation', 'exacerbation risk', 'COPD Inhaler Regimenswith Mortality, Respiratory Exacerbations, and Quality of Life', 'risk of pneumonia', 'time-to composite outcome or death', 'time-to death or first hospitalization for COPD']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",738.0,0.234867,We found no difference in time-to composite outcome or death among patients reporting regimens aligning with recommendations compared to undertreated patients.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Keller', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA. Electronic address: tlk33@uw.edu.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Spece', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Lucas M', 'Initials': 'LM', 'LastName': 'Donovan', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Edmunds', 'Initials': 'E', 'LastName': 'Udris', 'Affiliation': 'Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Coggeshall', 'Affiliation': 'Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Griffith', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Alexander D', 'Initials': 'AD', 'LastName': 'Bryant', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Casaburi', 'Affiliation': 'Los Angeles Biomedical Research Institute at Harbor - UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'J Allen', 'Initials': 'JA', 'LastName': 'Cooper', 'Affiliation': 'Birmingham VA Medical Center and the Lung Health Center, University of Alabama Birmingham, Birmingham, AL.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Temple University School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Philip T', 'Initials': 'PT', 'LastName': 'Diaz', 'Affiliation': '201 Heart Lung Institute, Ohio State University School of Medicine, Columbus, OH.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Fuhlbrigge', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Gay', 'Affiliation': 'University of Michigan School of Medicine, Ann Arbor, MI.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Kanner', 'Affiliation': 'University of Utah Health Sciences Center, Salt Lake City, UT.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Ralph J', 'Initials': 'RJ', 'LastName': 'Panos', 'Affiliation': 'Cincinnati VA Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shade', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Sternberg', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Stibolt', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Stoller', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland, OH.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tonascia', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wise', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Roger D', 'Initials': 'RD', 'LastName': 'Yusen', 'Affiliation': 'Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Au', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Feemster', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}]",Chest,['10.1016/j.chest.2020.02.073']
254,32278781,"Effect of Venlafaxine on Apnea-Hypopnea Index in Patients With Sleep Apnea: A Randomized, Double-Blind Crossover Study.","BACKGROUND


One of the key mechanisms underlying OSA is reduced pharyngeal muscle tone during sleep. Data suggest that pharmacologic augmentation of central serotonergic/adrenergic tone increases pharyngeal muscle tone.
RESEARCH QUESTION


We hypothesized that venlafaxine, a serotonin-norepinephrine reuptake inhibitor, would improve OSA severity.
STUDY DESIGN AND METHODS


In this mechanistic, randomized, double-blind, placebo-controlled crossover trial, 20 patients with OSA underwent two overnight polysomnograms ≥ 4 days apart, receiving either 50 mg of immediate-release venlafaxine or placebo before bedtime. Primary outcomes were the apnea-hypopnea index (AHI) and peripheral oxygen saturation (Spo 2 ) nadir, and secondary outcomes included sleep parameters and pathophysiologic traits with a view toward understanding the impact of venlafaxine on mechanisms underlying OSA.
RESULTS


Overall, there was no significant difference between venlafaxine and placebo regarding AHI (mean reduction, -5.6 events/h [95% CI, -12.0 to 0.9]; P = .09) or Spo 2  nadir (median increase, +1.0% [-0.5 to 5]; P = .11). Venlafaxine reduced total sleep time, sleep efficiency, and rapid eye movement (REM) sleep, while increasing non-REM stage 1 sleep (P all  < .05). On the basis of exploratory post hoc analyses venlafaxine decreased (""improved"") the ventilatory response to arousal (-30%; P = .049) and lowered (""worsened"") the predicted arousal threshold (-13%; [P = .02]; ie, more arousable), with no effects on other pathophysiologic traits (P all  ≥ .3). Post hoc analyses further suggested effect modification by arousal threshold (P = .002): AHI improved by 19% in patients with a high arousal threshold (-10.9 events/h [-3.9 to -17.9]) but tended to increase in patients with a low arousal threshold (+7 events/h [-2.0 to 16]). Other predictors of response were elevated AHI and less collapsible upper airway anatomy at baseline (|r| > 0.5, P ≤ .02).
INTERPRETATION


In unselected patients, venlafaxine simultaneously worsened and improved various pathophysiologic traits, resulting in a zero net effect. Careful patient selection based on pathophysiologic traits, or combination therapy with drugs countering its alerting effects, may produce a more robust response.
TRIAL REGISTRY


ClinicalTrials.gov; No.: NCT02714400; URL: www.clinicaltrials.gov.",2020,"Based on exploratory post hoc analyses venlafaxine decreased (""improved"") the ventilatory response to arousal (-30%, P=.049) and lowered (""worsened"") the predicted arousal threshold (-13%, P=.02; i.e. more arousable), with no effects on other pathophysiological traits (P all ≥.3).","['and Methods', 'obstructive sleep apnea (OSA', 'Patients with Sleep Apnea ', '20 OSA patients underwent two', 'patients with a high arousal threshold (-10.9/h']","['venlafaxine', 'Venlafaxine', 'overnight polysomnograms >4days apart receiving either 50mg immediate-release venlafaxine or placebo', 'placebo']","['Apnea Hypopnea Index', 'ventilatory response to arousal', 'total sleep time, sleep efficiency and rapid eye movement (REM) sleep', 'pathophysiological traits', 'apnea hypopnea index (AHI) and SpO 2  nadir; secondary outcomes included sleep parameters and pathophysiological traits with a view towards understanding its impact on mechanisms underlying OSA']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]","[{'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0037322', 'cui_str': 'Rapid eye movement sleep'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]",20.0,0.290939,"Based on exploratory post hoc analyses venlafaxine decreased (""improved"") the ventilatory response to arousal (-30%, P=.049) and lowered (""worsened"") the predicted arousal threshold (-13%, P=.02; i.e. more arousable), with no effects on other pathophysiological traits (P all ≥.3).","[{'ForeName': 'Christopher N', 'Initials': 'CN', 'LastName': 'Schmickl', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Yanru', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA; Department of Otorhinolaryngology Head and Neck Surgery, Sleep Medicine Center, Beijing Tongren Hospital, Capital Medical University, Beijing, China. Electronic address: liyanruru@aliyun.com.'}, {'ForeName': 'Jeremy E', 'Initials': 'JE', 'LastName': 'Orr', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Jen', 'Affiliation': 'Division of Respiratory Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Sands', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Edwards', 'Affiliation': 'Sleep and Circadian Medicine Laboratory, Department of Physiology, School of Biomedical Sciences and Biomedical Discovery Institute, Monash University, Melbourne, VIC, Australia; Turner Institute for Brain and Mental Health, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'DeYoung', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Owens', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA.'}]",Chest,['10.1016/j.chest.2020.02.074']
255,31731885,Short Communication: Metformin Reduces CD4 T Cell Exhaustion in HIV-Infected Adults on Suppressive Antiretroviral Therapy.,"Increased negative immune checkpoint receptors (NCR) on T cells are linked to T cell exhaustion, dysfunctional effector responses, and HIV viral persistence. Metformin, an oral hypoglycemic agent used for diabetes, may have previously unrecognized beneficial immunologic effects. Using cryopreserved blood from a 24-week pilot study involving 12 virally suppressed HIV-infected individuals randomized 1:1 to metformin versus observation (OBS), we assessed change in the frequencies of T cell activation (CD38 + HLA-DR + ) and NCR [programmed cell death protein 1 (PD1), T cell immunoreceptor with Ig and ITIM domains (TIGIT), and T cell mucin-domain containing-3 (TIM3)]. No differences in 24-week change were seen between arms in CD4 or CD8 T cells, in the CD4/CD8 ratio, or in activated (CD38 + HLA-DR + ) CD4 or CD8 T cells. However, metformin over 24 weeks led to decreases compared with OBS in single PD1 +  (percent decrease: -9.6% vs. 7.5%,  p  = .015), in dual PD1 + TIGIT +  (-15.0% vs. 10.4%,  p  = .002), and in triple PD1 + TIGIT + TIM3 +  (-24.0% vs. 8.1%,  p  = .041) CD4 T cells. Metformin led to no changes in CD8 T cell NCR frequencies. Metformin decreases the frequency of PD1 + , PD1 + TIGIT + , and PD1 + TIGIT + TIM3 +  expressing CD4 T cells. This may have relevance to HIV cure strategies and to efforts to mitigate the risk of chronic complications of HIV.",2020,"No differences in 24-week change were seen between arms in CD4 or CD8 T-cells, in the CD4/CD8 ratio, or in activated (CD38+HLA-DR+) CD4 or CD8 T-cells.","['HIV-Infected Adults on Suppressive Antiretroviral Therapy', 'Using cryopreserved blood from a 24-week pilot study involving 12 virally-suppressed HIV-infected individuals randomized 1:1 to']","['metformin vs observation (OBS', 'metformin', 'Metformin']","['CD8 T-cell NCR frequencies', 'CD4 or CD8 T-cells, in the CD4/CD8 ratio, or in activated (CD38+HLA-DR+) CD4 or CD8 T-cells', 'frequencies of T-cell activation (CD38+HLA-DR+) and NCR (programmed cell death protein 1 [PD1], T-cell immunoreceptor with Ig and ITIM domains [TIGIT], and T-cell mucin-domain containing-3 [TIM3', 'frequency of PD1+, PD1+TIGIT+ and PD1+TIGIT+TIM3+ expressing CD4 T-cells', 'CD4 T-Cell Exhaustion']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205367', 'cui_str': 'Suppressive (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0005768'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1564881', 'cui_str': 'Apoptosis Regulatory Proteins'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0026682', 'cui_str': 'Mucins'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}]",,0.027339,"No differences in 24-week change were seen between arms in CD4 or CD8 T-cells, in the CD4/CD8 ratio, or in activated (CD38+HLA-DR+) CD4 or CD8 T-cells.","[{'ForeName': 'Cecilia M', 'Initials': 'CM', 'LastName': 'Shikuma', 'Affiliation': 'Department of Medicine, John A. Burns School of Medicine, University of Hawaii - Manoa, Honolulu, Hawaii.'}, {'ForeName': 'Glen M', 'Initials': 'GM', 'LastName': 'Chew', 'Affiliation': 'Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine, University of Hawaii - Manoa, Honolulu, Hawaii.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Kohorn', 'Affiliation': 'Department of Medicine, John A. Burns School of Medicine, University of Hawaii - Manoa, Honolulu, Hawaii.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Souza', 'Affiliation': 'Department of Medicine, John A. Burns School of Medicine, University of Hawaii - Manoa, Honolulu, Hawaii.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Chow', 'Affiliation': 'Department of Medicine, John A. Burns School of Medicine, University of Hawaii - Manoa, Honolulu, Hawaii.'}, {'ForeName': 'Ivo Novita', 'Initials': 'IN', 'LastName': 'SahBandar', 'Affiliation': 'Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine, University of Hawaii - Manoa, Honolulu, Hawaii.'}, {'ForeName': 'Eun-Young', 'Initials': 'EY', 'LastName': 'Park', 'Affiliation': 'Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine, University of Hawaii - Manoa, Honolulu, Hawaii.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Hanks', 'Affiliation': 'Department of Medicine, John A. Burns School of Medicine, University of Hawaii - Manoa, Honolulu, Hawaii.'}, {'ForeName': 'Louie Mar A', 'Initials': 'LMA', 'LastName': 'Gangcuangco', 'Affiliation': 'Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine, University of Hawaii - Manoa, Honolulu, Hawaii.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Gerschenson', 'Affiliation': 'Department of Cell and Molecular Biology, John A. Burns School of Medicine, University of Hawaii - Manoa, Honolulu, Hawaii.'}, {'ForeName': 'Lishomwa C', 'Initials': 'LC', 'LastName': 'Ndhlovu', 'Affiliation': 'Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine, University of Hawaii - Manoa, Honolulu, Hawaii.'}]",AIDS research and human retroviruses,['10.1089/AID.2019.0078']
256,32278783,Re-evaluation of the Uplift Clinical Trial Using Age-Appropriate Spirometric Criteria.,"BACKGROUND


The clinical trial of tiotropium in COPD, UPLIFT, enrolled adults with a mean age of 65 years and moderate-to-severe airflow obstruction, based on criteria from the Global Initiative for Chronic Obstructive Lung Disease (GOLD). For the UPLIFT cohort, however, GOLD-based criteria are not age-appropriate.
RESEARCH QUESTION


Will the use of more age-appropriate criteria for airflow obstruction from the Global Lung Function Initiative (GLI) modify the spirometric classification of the UPLIFT cohort and, in turn, the mortality effect of tiotropium in COPD?
STUDY DESIGN AND METHODS


Baseline spirometric classifications were first cross-tabulated by GLI- and GOLD-based criteria. Next, in GLI- and GOLD-based airflow obstruction, modified intention-to-treat analyses evaluated differences in time to death over 4 years, comparing tiotropium vs placebo. Because treatment response may differ by COPD severity, the mortality effect also was evaluated within stratum defined by GLI- and GOLD-based moderate and severe airflow obstruction.
RESULTS


Of 5,898 participants with GOLD-based airflow-obstruction, staged as moderate in 2,739 (46.4%) and severe in 3,156 (53.5%), GLI-based criteria established airflow obstruction in 5,750 (97.5%), staged as moderate in 795 (13.5%) and severe in 4,947 (83.9%). Relative to placebo, tiotropium yielded statistically nonsignificant adjusted hazard ratios (adjHRs) (95% CI) for death of 0.91 (0.80-1.04) and 0.91 (0.79-1.03) in GLI- and GOLD-based airflow obstruction, respectively. However, statistically significant effect modification was observed, but only in GLI-based moderate and severe airflow-obstruction, with tiotropium yielding adjHRs for death of 0.53 (0.34-0.81) and 0.99 (0.86-1.13), respectively. The P value for interaction was .007.
INTERPRETATION


Mortality reduction by tiotropium was only statistically significant in GLI-based moderate airflow-obstruction, a group that was underrepresented in UPLIFT because of severity misclassification by the original GOLD-based enrollment criteria.",2020,"Relative to placebo, tiotropium yielded statistically non-significant adjusted hazard ratios (adjHRs) (95% confidence interval) for death of 0.91 (0.80, 1.04) and 0.91 (0.79, 1.03) in GLI- and GOLD-based airflow-obstruction, respectively.","['and Methods', 'chronic obstructive pulmonary disease (COPD), i.e. UPLIFT, enrolled adults with a mean age of 65 years and moderate-to-severe airflow-obstruction, based on criteria from the Global Initiative for Chronic Obstructive Lung Disease (GOLD', '5898 participants with GOLD-based']","['placebo, tiotropium', 'tiotropium', 'tiotropium vs. placebo']","['GLI-based moderate and severe airflow-obstruction', 'GLI-based criteria established airflow-obstruction', 'hazard ratios (adjHRs', 'mortality effect', 'Mortality reduction', 'airflow-obstruction']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",5898.0,0.179374,"Relative to placebo, tiotropium yielded statistically non-significant adjusted hazard ratios (adjHRs) (95% confidence interval) for death of 0.91 (0.80, 1.04) and 0.91 (0.79, 1.03) in GLI- and GOLD-based airflow-obstruction, respectively.","[{'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Vaz Fragoso', 'Affiliation': 'Veterans Affairs (VA) Connecticut Healthcare System, West Haven; Yale University School of Medicine, Department of Internal Medicine, New Haven, CT. Electronic address: carlos.fragoso@yale.edu.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Leo-Summers', 'Affiliation': 'Yale University School of Medicine, Department of Internal Medicine, New Haven, CT.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Gill', 'Affiliation': 'Yale University School of Medicine, Department of Internal Medicine, New Haven, CT.'}, {'ForeName': 'Gail J', 'Initials': 'GJ', 'LastName': 'McAvay', 'Affiliation': 'Yale University School of Medicine, Department of Internal Medicine, New Haven, CT.'}]",Chest,['10.1016/j.chest.2020.02.070']
257,32008809,"Feasibility and acceptability of active for life with COPD, an intervention to increase light physical activity in people with COPD.","BACKGROUND


People with chronic obstructive pulmonary disease (COPD) are very sedentary; increasing light physical activity (LPA) may help to promote long-term maintenance of physical activity.
OBJECTIVES


We evaluated feasibility and acceptability of Active for Life with COPD, a self-efficacy-enhancing intervention designed to increase LPA.
METHODS


The 10-week intervention included walking, functional circuit training, and behavioral and educational strategies. Measures included attrition, adherence, objectively measured physical activity, and qualitative interviews.
RESULTS


Thirty-six subjects enrolled in the study; 26 completed the intervention and 19 completed the two-month follow-up. Subjects reported the intervention was enjoyable and beneficial, but disliked the activity log and buddy system. Subjects increased mean time spent standing/stepping by 36 (SD = 82) min/24 h (P > 0.05); they retained a gain of 21 (SD = 88) min/24 h at the two-month follow-up (P > 0.05).
CONCLUSIONS


The Active for Life with COPD intervention is feasible, acceptable, and may support long term maintenance of physical activity.",2020,Subjects increased mean time spent standing/stepping by 36 (SD = 82) min/24 ,"['Thirty-six subjects enrolled in the study; 26 completed the intervention and 19 completed the two-month follow-up', '88) min/24', 'People with chronic obstructive pulmonary disease (COPD', 'people with COPD']","['walking, functional circuit training, and behavioral and educational strategies', 'COPD intervention']","['light physical activity', 'attrition, adherence, objectively measured physical activity, and qualitative interviews', 'mean time spent standing/stepping']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1261552', 'cui_str': 'Step'}]",36.0,0.0437589,Subjects increased mean time spent standing/stepping by 36 (SD = 82) min/24 ,"[{'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Larson', 'Affiliation': 'University of Michigan School of Nursing, 400 North Ingalls Building, Ann Arbor, MI 48109-5482, United States. Electronic address: janetlar@umich.edu.'}, {'ForeName': 'Katelyn E', 'Initials': 'KE', 'LastName': 'Webster', 'Affiliation': 'University of Michigan School of Nursing, 400 North Ingalls Building, Ann Arbor, MI 48109-5482, United States.'}]",Heart & lung : the journal of critical care,['10.1016/j.hrtlng.2020.01.002']
258,32275060,"Implementation of a Transitional Care Model for Stroke: Perspectives From Frontline Clinicians, Administrators, and COMPASS-TC Implementation Staff.","BACKGROUND AND OBJECTIVES


Stroke is a chronic, complex condition that disproportionally affects older adults. Health systems are evaluating innovative transitional care (TC) models to improve outcomes in these patients. The Comprehensive Post-Acute Stroke Services (COMPASS) Study, a large cluster-randomized pragmatic trial, tested a TC model for patients with stroke or transient ischemic attack discharged home from the hospital. The implementation of COMPASS-TC in complex real-world settings was evaluated to identify successes and challenges with integration into the clinical workflow.
RESEARCH DESIGN AND METHODS


We conducted a concurrent process evaluation of COMPASS-TC implementation during the first year of the trial. Qualitative data were collected from 4 sources across 19 intervention hospitals. We analyzed transcripts from 43 conference calls with hospital clinicians, individual and group interviews with leaders and clinicians from 9 hospitals, and 2 interviews with the COMPASS-TC Director of Implementation using iterative thematic analysis. Themes were compared to the domains of the RE-AIM framework.
RESULTS


Organizational, individual, and community factors related to Reach, Adoption, and Implementation were identified. Organizational readiness was an additional key factor to successful implementation, in that hospitals that were not ""organizationally ready"" had more difficulty addressing implementation challenges.
DISCUSSION AND IMPLICATIONS


Multifaceted TC models are challenging to implement. Facilitators of implementation were organizational commitment and capacity, prioritizing implementation of innovative delivery models to provide comprehensive care, being able to address challenges quickly, implementing systems for tracking patients throughout the intervention, providing clinicians with autonomy and support to address challenges, and adequately resourcing the intervention.
CLINICAL TRIAL REGISTRATION


NCT02588664.",2020,"The implementation of COMPASS-TC in complex real-world settings was evaluated to identify successes and challenges with integration into the clinical workflow.
","['43 conference calls with hospital clinicians, individual and group interviews with leaders and clinicians from 9 hospitals, and 2 interviews with the COMPASS-TC Director of Implementation using iterative thematic analysis', 'older adults', 'patients with stroke or transient ischemic attack discharged home from the hospital']","['COMPASS-TC implementation', 'TC model']",[],"[{'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018260', 'cui_str': 'Group Interviews'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]",[],,0.0397485,"The implementation of COMPASS-TC in complex real-world settings was evaluated to identify successes and challenges with integration into the clinical workflow.
","[{'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Lutz', 'Affiliation': 'School of Nursing, University of North Carolina at Wilmington.'}, {'ForeName': 'Alexandria E', 'Initials': 'AE', 'LastName': 'Reimold', 'Affiliation': 'School of Nursing, University of North Carolina at Wilmington.'}, {'ForeName': 'Sylvia W', 'Initials': 'SW', 'LastName': 'Coleman', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Guzik', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Laurie P', 'Initials': 'LP', 'LastName': 'Russell', 'Affiliation': 'Division of Public Health Sciences, Wake Forest University Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Meghan D', 'Initials': 'MD', 'LastName': 'Radman', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Johnson', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Pamela W', 'Initials': 'PW', 'LastName': 'Duncan', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Cheryl D', 'Initials': 'CD', 'LastName': 'Bushnell', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Wayne D', 'Initials': 'WD', 'LastName': 'Rosamond', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Sabina B', 'Initials': 'SB', 'LastName': 'Gesell', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}]",The Gerontologist,['10.1093/geront/gnaa029']
259,32275315,Effective Peer Leader Attributes for the Promotion of Walking in Older Adults.,"BACKGROUND AND OBJECTIVES


Peer-led interventions are promising for the promotion of physical activity behavior in older adults. However, little is known about the attributes of effective older peer leaders in such intervention programs. The objective was to determine what older adults perceive to be effective peer leader attributes.
RESEARCH DESIGN AND METHODS


A mixed-methods concurrent triangulation design was used. Participants, aged 60 years and older, were recruited from retirement villages and existing walking groups in Western Australia. They were predominantly white, Australian-born, female, healthy retirees. The sample consisted of four groups of older adults: those who had taken part in past peer-led walking programs (experienced walkers; n = 18), those interested in joining as walkers in a peer-led walking intervention (inexperienced walkers; n = 43), those interested to take on a peer leader role (inexperienced peer leaders; n = 25), and those who had already served as peer leaders (experienced peer leaders; n = 15). Questionnaires measured perceived effective leadership attributes, and physical activity was measured using ActivPAL devices (N = 101; Mage [SD] = 75.36 [7.59]). Semistructured interviews were conducted with the majority of participants (N = 68; Mage [SD] = 74.68 [7.78]).
RESULTS


Overall, participants described an effective peer leader as optimistic, compassionate, and friendly, but differences in perceptions were apparent between the groups.
DISCUSSION AND IMPLICATIONS


Our findings advance knowledge about important characteristics of an effective older peer leader, which can inform peer leader training, recruitment of peer leaders, and future scale development.",2020,"Overall, participants described an effective peer leader as optimistic, compassionate, and friendly, but differences in perceptions were apparent between the groups.
","['older adults', 'older adults: those who had taken part in past peer-led walking programs (experienced walkers; n = 18), those interested in joining as walkers in a peer-led walking intervention (inexperienced walkers; n = 43), those interested to take on a peer leader role (inexperienced peer leaders; n = 25), and those who had already served as peer leaders (experienced peer leaders; n = 15', 'Participants, aged 60 years and older, were recruited from retirement villages and existing walking groups in Western Australia', 'They were predominantly white, Australian-born, female, healthy retirees', 'Older Adults']",[],"['effective leadership attributes, and physical activity']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043016', 'cui_str': 'Walker'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0035345', 'cui_str': 'Retired'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0261899,"Overall, participants described an effective peer leader as optimistic, compassionate, and friendly, but differences in perceptions were apparent between the groups.
","[{'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Kritz', 'Affiliation': 'Health Psychology and Behavioral Medicine Research Group, School of Psychology, Curtin University, Perth, Western Australia.'}, {'ForeName': 'Cecilie', 'Initials': 'C', 'LastName': 'Thøgersen-Ntoumani', 'Affiliation': 'Health Psychology and Behavioral Medicine Research Group, School of Psychology, Curtin University, Perth, Western Australia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Mullan', 'Affiliation': 'Health Psychology and Behavioral Medicine Research Group, School of Psychology, Curtin University, Perth, Western Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'McVeigh', 'Affiliation': 'Physical Activity and Wellbeing Research Group, School of Psychology, Curtin University, Perth, Western Australia.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Ntoumanis', 'Affiliation': 'Health Psychology and Behavioral Medicine Research Group, School of Psychology, Curtin University, Perth, Western Australia.'}]",The Gerontologist,['10.1093/geront/gnaa014']
260,32271690,Health Related Quality of Life of Patients with Bladder Cancer in the RAZOR Trial: A Multi-Institutional Randomized Trial Comparing Robot versus Open Radical Cystectomy.,"PURPOSE


We evaluated health related quality of life following robotic and open radical cystectomy as a treatment for bladder cancer.
MATERIALS AND METHODS


Using the Randomized Open versus Robotic Cystectomy (RAZOR) trial population we assessed health related quality of life by using the Functional Assessment of Cancer Therapy (FACT)-Vanderbilt Cystectomy Index and the Short Form 8 Health Survey (SF-8) at baseline, 3 and 6 months postoperatively. The primary objective was to assess the impact of surgical approach on health related quality of life. As an exploratory analysis we assessed the impact of urinary diversion type on health related quality of life.
RESULTS


Analyses were performed in subsets of the per-protocol population of 302 patients. There was no statistically significant difference between the mean scores by surgical approach at any time point for any FACT-Vanderbilt Cystectomy Index subscale or composite score (p >0.05). The emotional well-being score increased over time in both surgical arms. Patients in the open arm showed significantly better SF-8 sores in the physical and mental summary scores at 6 months compared to baseline (p <0.05). Continent diversion (versus noncontinent) was associated with worse FACT-bladder-cystectomy score at 3 (p <0.01) but not at 6 months, and the SF-8 physical component was better in continent-diversion patients at 6 months (p=0.019).
CONCLUSIONS


Our data suggests lack of significant differences in the health related quality of life in robotic and open cystectomies. As robotic procedures become more widespread it is important to discuss this finding during counseling.",2020,There was no statistically significant difference between the mean scores by surgical approach at any time point for any FACT-VCI subscale or composite score (p>0.05).,['Patients with Bladder Cancer'],"['Robot versus Open Radical Cystectomy', 'Robotic Cystectomy (RAZOR', 'robotic and open radical cystectomy']","['worse FACT-BL-cys score', 'SF-8 physical component', 'Continent diversion', 'SF-8 sores', 'FACT-VCI subscale or composite score', 'Health-Related Quality of Life', 'health-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0010651', 'cui_str': 'Bladder excision'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0010654', 'cui_str': 'Cysteine'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0429956', 'cui_str': 'Bowels: fully continent'}, {'cui': 'C0185033', 'cui_str': 'Diversion procedure'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",302.0,0.140481,There was no statistically significant difference between the mean scores by surgical approach at any time point for any FACT-VCI subscale or composite score (p>0.05).,"[{'ForeName': 'Maria F', 'Initials': 'MF', 'LastName': 'Becerra', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Venkatramani', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Isildinha M', 'Initials': 'IM', 'LastName': 'Reis', 'Affiliation': 'Division of Biostatistics, Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida.'}, {'ForeName': 'Nachiketh', 'Initials': 'N', 'LastName': 'Soodana-Prakash', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Sanoj', 'Initials': 'S', 'LastName': 'Punnen', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Gonzalgo', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Shyamal', 'Initials': 'S', 'LastName': 'Raolji', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Erik P', 'Initials': 'EP', 'LastName': 'Castle', 'Affiliation': 'Department of Urology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Woods', 'Affiliation': 'Department of Urology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Svatek', 'Affiliation': 'Department of Urology, Division of Urologic Oncology, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Alon Z', 'Initials': 'AZ', 'LastName': 'Weizer', 'Affiliation': 'Department of Urology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Badrinath R', 'Initials': 'BR', 'LastName': 'Konety', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Tollefson', 'Affiliation': 'Department of Urology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Tracey L', 'Initials': 'TL', 'LastName': 'Krupski', 'Affiliation': 'Department of Urology, University of Virginia Health Science Center, Charlottesville, Virginia.'}, {'ForeName': 'Norm D', 'Initials': 'ND', 'LastName': 'Smith', 'Affiliation': 'Department of Urology, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Shabsigh', 'Affiliation': 'Department of Urology, Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Barocas', 'Affiliation': 'Department of Urology, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Marcus L', 'Initials': 'ML', 'LastName': 'Quek', 'Affiliation': 'Department of Urology, Loyola University Medical Center, Maywood, Illinois.'}, {'ForeName': 'Atreya', 'Initials': 'A', 'LastName': 'Dash', 'Affiliation': 'Department of Urology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Dipen J', 'Initials': 'DJ', 'LastName': 'Parekh', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}]",The Journal of urology,['10.1097/JU.0000000000001029']
261,32271151,A Social Group-Based Information-Motivation-Behavior Skill Intervention to Promote Acceptability and Adoption of Wearable Activity Trackers Among Middle-Aged and Older Adults: Cluster Randomized Controlled Trial.,"BACKGROUND


Wearable activity trackers offer potential to optimize behavior and support self-management. To assist older adults in benefiting from mobile technologies, theory-driven deployment strategies are needed to overcome personal, technological, and sociocontextual barriers in technology adoption.
OBJECTIVE


To test the effectiveness of a social group-based strategy to improve the acceptability and adoption of activity trackers by middle-aged and older adults.
METHODS


A cluster randomized controlled trial was conducted among 13 groups of middle-aged and older adults (≥45 years) performing group dancing (ie, square dancing) as a form of exercise in Guangzhou from November 2017 to October 2018. These dancing groups were randomized 1:1 into two arms, and both received wrist-worn activity trackers and instructions at the baseline face-to-face assessment. Based on the Information-Motivation-Behavior Skill framework, the intervention arm was also given a tutorial on the purpose of exercise monitoring (Information), encouraged to participate in exercise and share their exercise records with their dancing peers (Motivation), and were further assisted with the use of the activity tracker (Behavior Skill). We examined two process outcomes: acceptability evaluated by a 14-item questionnaire, and adoption assessed by the uploaded step count data. Intention-to-treat analysis was applied, with the treatment effects estimated by multilevel models.
RESULTS


All dancing groups were followed up for the postintervention reassessment, with 61/69 (88%) participants of the intervention arm (7 groups) and 56/80 (70%) participants of the control arm (6 groups). Participants' sociodemographic characteristics (mean age 62 years, retired) and health status were comparable between the two arms, except the intervention arm had fewer female participants and lower cognitive test scores. Our intervention significantly increased the participants' overall acceptability by 6.8 points (95% CI 2.2-11.4), mainly driven by promoted motivation (adjusted group difference 2.0, 95% CI 0.5-3.6), increased usefulness (adjusted group difference 2.5, 95% CI 0.9-4.1), and better perceived ease of use (adjusted group difference 1.2, 95% CI 0.1-2.4), whereas enjoyment and comfort were not increased (adjusted group difference 0.9, 95% CI -0.4-2.3). Higher adoption was also observed among participants in the intervention arm, who were twice as likely to have valid daily step account data than their controlled counterparts (adjusted incidence relative risk [IRR]=2.0, 95% CI 1.2-3.3). The average daily step counts (7803 vs 5653 steps/day for the intervention and control, respectively) were similar between the two arms (adjusted IRR=1.4, 95% CI 0.7-2.5).
CONCLUSIONS


Our social group-based deployment strategy incorporating information, motivation, and behavior skill components effectively promoted acceptability and adoption of activity trackers among community-dwelling middle-aged and older adults. Future studies are needed to examine the long-term effectiveness and apply this social engagement strategy in other group settings or meeting places.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR-IOC-17013185; https://tinyurl.com/vedwc7h.",2020,"Our intervention significantly increased the participants' overall acceptability by 6.8 points (95% CI 2.2-11.4), mainly driven by promoted motivation (adjusted group difference 2.0, 95% CI 0.5-3.6), increased usefulness (adjusted group difference 2.5, 95% CI 0.9-4.1), and better perceived ease of use (adjusted group difference 1.2, 95% CI 0.1-2.4), whereas enjoyment and comfort were not increased (adjusted group difference 0.9, 95% CI -0.4-2.3).","['13 groups of middle-aged and older adults (≥45 years) performing group dancing (ie, square dancing) as a form of exercise in Guangzhou from November 2017 to October 2018', 'middle-aged and older adults', 'Middle-Aged and Older Adults', 'community-dwelling middle-aged and older adults']","['wrist-worn activity trackers and instructions at the baseline face-to-face assessment', 'exercise monitoring (Information), encouraged to participate in exercise and share their exercise records with their dancing peers (Motivation', 'social group-based strategy', 'Social Group-Based Information-Motivation-Behavior Skill Intervention']","['enjoyment and comfort', 'average daily step counts', 'cognitive test scores', 'health status', ""participants' overall acceptability"", 'acceptability and adoption of activity trackers']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0687744', 'cui_str': 'Social group'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}]",,0.151369,"Our intervention significantly increased the participants' overall acceptability by 6.8 points (95% CI 2.2-11.4), mainly driven by promoted motivation (adjusted group difference 2.0, 95% CI 0.5-3.6), increased usefulness (adjusted group difference 2.5, 95% CI 0.9-4.1), and better perceived ease of use (adjusted group difference 1.2, 95% CI 0.1-2.4), whereas enjoyment and comfort were not increased (adjusted group difference 0.9, 95% CI -0.4-2.3).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Department of Medical Statistics & Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Hai-Yan', 'Initials': 'HY', 'LastName': 'Xiao', 'Affiliation': 'Department of Medical Statistics & Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xue-Qi', 'Initials': 'XQ', 'LastName': 'Li', 'Affiliation': 'Department of Medical Statistics & Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Shu-Hua', 'Initials': 'SH', 'LastName': 'Sun', 'Affiliation': 'Division of Health Management, Shayuan Primary Health Care Center, Guangzhou, China.'}, {'ForeName': 'Shi-Xing', 'Initials': 'SX', 'LastName': 'Liu', 'Affiliation': 'Division of Health Management, Shayuan Primary Health Care Center, Guangzhou, China.'}, {'ForeName': 'Yung-Jen', 'Initials': 'YJ', 'LastName': 'Yang', 'Affiliation': 'Taiwanese Society of Geriatric Psychiatry, Taiwan, China.'}, {'ForeName': 'Dong Roman', 'Initials': 'DR', 'LastName': 'Xu', 'Affiliation': 'Sun Yat-sen Global Health Institute, School of Public Health and Institute of State Governance, Sun Yat-sen University, Guangzhou, China.'}]",JMIR mHealth and uHealth,['10.2196/14969']
262,32272776,"Protein-Bound Uremic Toxins in Hemodialysis Patients Relate to Residual Kidney Function, Are Not Influenced by Convective Transport, and Do Not Relate to Outcome.","Protein-bound uremic toxins (PBUTs) are predominantly excreted by renal tubular secretion and hardly removed by traditional hemodialysis (HD). Accumulation of PBUTs is proposed to contribute to the increased morbidity and mortality of patients with end-stage kidney disease (ESKD). Preserved PBUT excretion in patients with residual kidney function (RKF) and/or increased PBUT clearance with improved dialysis techniques might improve the prognosis of patients with ESKD. The aims of this study are to explore determinants of PBUTs in HD patients, and investigate whether hemodiafiltration (HDF) lowers PBUT plasma concentrations, and whether PBUTs are related to the outcome. Predialysis total plasma concentrations of kynurenine, kynurenic acid, indoxyl sulfate, indole-3-acetic acid, p-cresyl sulfate, p-cresyl glucuronide, and hippuric acid were measured by UHPLC-MS at baseline and after 6 months of follow-up in the first 80 patients participating in the CONvective TRAnsport Study (CONTRAST), a randomized controlled trial that compared the effects of online HDF versus low-flux HD on all-cause mortality and new cardiovascular events. RKF was inversely related to kynurenic acid ( p  < 0.001), indoxyl sulfate ( p  = 0.001), indole-3-acetic acid ( p  = 0.024), p-cresyl glucuronide ( p  = 0.004) and hippuric acid ( p  < 0.001) plasma concentrations. Only indoxyl sulfate decreased by 8.0% (-15.3 to 34.6) in patients treated with HDF and increased by 11.9% (-15.4 to 31.9) in HD patients after 6 months of follow-up (HDF vs. HD:  p  = 0.045). No independent associations were found between PBUT plasma concentrations and either risk of all-cause mortality or new cardiovascular events. In summary, in the current population, RKF is an important determinant of PBUT plasma concentrations in HD patients. The addition of convective transport did not consistently decrease PBUT plasma concentrations and no relation was found between PBUTs and cardiovascular endpoints.",2020,"RKF was inversely related to kynurenic acid ( p  < 0.001), indoxyl sulfate ( p  = 0.001), indole-3-acetic acid ( p  = 0.024), p-cresyl glucuronide ( p  = 0.004) and hippuric acid ( p  < 0.001) plasma concentrations.","['HD patients', 'patients with residual kidney function (RKF', 'patients with end-stage kidney disease (ESKD']","['hemodiafiltration (HDF', 'online HDF versus low-flux HD']","['indoxyl sulfate', 'hippuric acid', 'Residual Kidney Function', 'kynurenic acid', 'indole-3-acetic acid', 'PBUT plasma concentrations and either risk of all-cause mortality or new cardiovascular events', 'Predialysis total plasma concentrations of kynurenine, kynurenic acid, indoxyl sulfate, indole-3-acetic acid, p-cresyl sulfate, p-cresyl glucuronide, and hippuric acid', 'RKF', 'PBUT plasma concentrations']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}]","[{'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0021210', 'cui_str': 'Indican'}, {'cui': 'C0062725', 'cui_str': 'Hippuric acid'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0022816', 'cui_str': 'Kynurenic acid'}, {'cui': 'C0936060', 'cui_str': 'Indoleacetic acid'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022818', 'cui_str': 'Kynurenine'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0752086', 'cui_str': 'Glucuronides'}]",80.0,0.0181568,"RKF was inversely related to kynurenic acid ( p  < 0.001), indoxyl sulfate ( p  = 0.001), indole-3-acetic acid ( p  = 0.024), p-cresyl glucuronide ( p  = 0.004) and hippuric acid ( p  < 0.001) plasma concentrations.","[{'ForeName': 'Maaike K', 'Initials': 'MK', 'LastName': 'van Gelder', 'Affiliation': 'Department of Nephrology and Hypertension, University Medical Center Utrecht, 3584 CX Utrecht, The Netherlands.'}, {'ForeName': 'Igor R', 'Initials': 'IR', 'LastName': 'Middel', 'Affiliation': 'Division of Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, 3584 CG Utrecht, The Netherlands.'}, {'ForeName': 'Robin W M', 'Initials': 'RWM', 'LastName': 'Vernooij', 'Affiliation': 'Department of Nephrology and Hypertension, University Medical Center Utrecht, 3584 CX Utrecht, The Netherlands.'}, {'ForeName': 'Michiel L', 'Initials': 'ML', 'LastName': 'Bots', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Utrecht, 3584 CG Utrecht, The Netherlands.'}, {'ForeName': 'Marianne C', 'Initials': 'MC', 'LastName': 'Verhaar', 'Affiliation': 'Department of Nephrology and Hypertension, University Medical Center Utrecht, 3584 CX Utrecht, The Netherlands.'}, {'ForeName': 'Rosalinde', 'Initials': 'R', 'LastName': 'Masereeuw', 'Affiliation': 'Division of Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, 3584 CG Utrecht, The Netherlands.'}, {'ForeName': 'Muriel P', 'Initials': 'MP', 'LastName': 'Grooteman', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Cardiovascular Sciences, Nephrology, 1081 HV Amsterdam, The Netherlands.'}, {'ForeName': 'Menso J', 'Initials': 'MJ', 'LastName': 'Nubé', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Cardiovascular Sciences, Nephrology, 1081 HV Amsterdam, The Netherlands.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'van den Dorpel', 'Affiliation': 'Department of Internal Medicine, Maasstad Hospital, 3079 DZ Rotterdam, The Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Blankestijn', 'Affiliation': 'Department of Nephrology and Hypertension, University Medical Center Utrecht, 3584 CX Utrecht, The Netherlands.'}, {'ForeName': 'Maarten B', 'Initials': 'MB', 'LastName': 'Rookmaaker', 'Affiliation': 'Department of Nephrology and Hypertension, University Medical Center Utrecht, 3584 CX Utrecht, The Netherlands.'}, {'ForeName': 'Karin G F', 'Initials': 'KGF', 'LastName': 'Gerritsen', 'Affiliation': 'Department of Nephrology and Hypertension, University Medical Center Utrecht, 3584 CX Utrecht, The Netherlands.'}]",Toxins,['10.3390/toxins12040234']
263,31640632,Persistent physical symptoms reduction intervention: a system change and evaluation in secondary care (PRINCE secondary) - a CBT-based transdiagnostic approach: study protocol for a randomised controlled trial.,"BACKGROUND


Persistent physical symptoms (PPS), also known as medically unexplained symptoms (MUS), affect approximately 50% of patients in secondary care and are often associated with disability, psychological distress and increased health care costs. Cognitive behavioural therapy (CBT) has demonstrated both short- and long-term efficacy with small to medium effect sizes for PPS, with larger treatment effects for specific PPS syndromes, including non-cardiac chest pain, irritable bowel syndrome (IBS) and chronic fatigue syndrome (CFS). Research indicates that PPS conditions share similar cognitive and behavioural responses to symptoms, such as avoidance and unhelpful beliefs. This suggests that a transdiagnostic approach may be beneficial for patients with PPS.
METHODS


A randomised controlled trial (RCT) will be conducted to evaluate the efficacy and cost-effectiveness of a transdiagnostic CBT-based intervention for PPS. 322 participants with PPS will be recruited from secondary care clinics. Participants stratified by clinic and disability level will be randomised to CBT plus standard medical care (SMC) versus SMC alone. The intervention consists of 8 CBT sessions delivered by a qualified therapist over a period of 20 weeks. Outcomes will be assessed at 9, 20, 40- and 52-weeks post randomisation. Efficacy will be assessed by examining the difference between arms in the primary outcome Work and Social Adjustment Scale (WSAS) at 52 weeks after randomisation. Secondary outcomes will include mood, symptom severity and clinical global impression at 9, 20, 40 and 52 weeks. Cost-effectiveness will be evaluated by combining measures of health service use, informal care, loss of working hours and financial benefits at 52 weeks.
DISCUSSION


This trial will provide a powered evaluation of the efficacy and cost-effectiveness of a transdiagnostic CBT approach versus SMC for patients with PPS. It will also provide valuable information about potential healthcare pathways for patients with PPS within the National Health Service (NHS).
TRIAL REGISTRATION


ClinicalTrials.gov NCT02426788. Registered 27 April 2015. Overall trial status: Ongoing; Recruitment status: No longer recruiting.",2019,Efficacy will be assessed by examining the difference between arms in the primary outcome Work and Social Adjustment Scale (WSAS) at 52 weeks after randomisation.,"['patients with PPS', 'Participants stratified by clinic and disability level', '322 participants with PPS will be recruited from secondary care clinics', 'patients with PPS within the National Health Service (NHS']","['transdiagnostic CBT approach versus SMC', 'CBT plus standard medical care (SMC) versus SMC alone', 'Cognitive behavioural therapy (CBT', 'transdiagnostic CBT-based intervention']","['Social Adjustment Scale (WSAS', 'Cost-effectiveness', 'Efficacy', 'mood, symptom severity and clinical global impression', 'efficacy and cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4517712', 'cui_str': 'Three hundred and twenty-two'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0451485', 'cui_str': 'Social adjustment scale (assessment scale)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",322.0,0.226477,Efficacy will be assessed by examining the difference between arms in the primary outcome Work and Social Adjustment Scale (WSAS) at 52 weeks after randomisation.,"[{'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK. trudie.chalder@kcl.ac.uk.""}, {'ForeName': 'Meenal', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'James', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hotopf', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Frank', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Watts', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""Health Economics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'David', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ashworth', 'Affiliation': ""Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Mujtaba', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Garrood', 'Affiliation': ""Department of Rheumatology, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Moss-Morris', 'Affiliation': ""School of Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Landau', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",BMC psychiatry,['10.1186/s12888-019-2297-y']
264,32272024,Influence of postexercise fasting on hunger and satiety in adults.,"Research demonstrates that exercise acutely reduces appetite by stimulating the secretion of gut-derived satiety hormones. Currently there is a paucity of research examining the impact of postexercise nutrient intake on appetite regulation. The objective of this study was to examine how postexercise fasting versus feeding impacts the postexercise appetite response. In a randomized crossover intervention, 14 participants (body mass index: 26.9 ± 3.5 kg·m -2 ; age: 26.8 ± 6.7 years) received 1 of 2 recovery beverages: ( i ) water control (FAST) or ( ii ) sweetened-milk (FED) after completing a 45-min (65%-70% peak oxygen uptake) evening exercise session (∼1900 h). Energy intake was assessed through a fasted ad libitum breakfast meal and 3-day food diaries. Perceived appetite was assessed using visual analogue scales. Appetite-regulating hormones glucagon-like peptide-1 (GLP-1), peptide tyrosine-tyrosine (PYY), and acyl-ghrelin were assessed pre-exercise, 1 h after exercise, and the morning following exercise. FAST increased subjective hunger compared with FED ( P  < 0.05). PYY and GLP-1 after exercise were decreased and acyl-ghrelin was increased in FAST, with these differences disappearing the day after exercise ( P  < 0.05). Ad libitum energy intake at breakfast the following morning did not differ between trials. Overall, in the absence of postexercise macronutrient consumption, there was a pronounced increase in objective and subjective appetite after exercise. The orexigenic effects of postexercise fasting, however, were not observed the morning following exercise.  Novelty  Postexercise fasting leads to reduced GLP-1 and PYY and increased hunger. Reduced GLP-1 and PYY after exercise is blunted by postexercise nutrient intake. Energy intake the day after exercise is not influenced by postexercise fasting.",2020,"PYY and GLP-1 after exercise were decreased and acyl-ghrelin was increased in FAST, with these differences disappearing the day after exercise (P<0.05).","['14 participants (BMI: 26.9 ± 3.5 kg·m-2; Age: 26.8 ± 6.7yrs) received', 'adults']","['post-exercise fasting', 'one of two recovery beverages: 1) water control (FAST) or 2) sweetened-milk (FED) after completing a 45min (65-70% VO2peak) evening exercise session (~1900hr']","['Perceived appetite', 'hunger and satiety', 'Appetite-regulating hormones GLP-1, PYY, and acyl-ghrelin', 'Novelty Bullets •', 'acyl-ghrelin', 'Energy intake', 'objective and subjective appetite post-exercise', 'hunger •', 'subjective hunger']","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0336699', 'cui_str': 'Bullet'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}]",,0.10911,"PYY and GLP-1 after exercise were decreased and acyl-ghrelin was increased in FAST, with these differences disappearing the day after exercise (P<0.05).","[{'ForeName': 'Courteney C', 'Initials': 'CC', 'LastName': 'Hamilton', 'Affiliation': 'Department of Kinesiology and Physical Education, University of Lethbridge, Lethbridge, AB T1K 3M4, Canada.'}, {'ForeName': 'Steve B', 'Initials': 'SB', 'LastName': 'Wiseman', 'Affiliation': 'Department of Biological Sciences, University of Lethbridge, Lethbridge, AB T1K 3M4, Canada.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Copeland', 'Affiliation': 'Department of Kinesiology and Physical Education, University of Lethbridge, Lethbridge, AB T1K 3M4, Canada.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Bomhof', 'Affiliation': 'Department of Kinesiology and Physical Education, University of Lethbridge, Lethbridge, AB T1K 3M4, Canada.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0947']
265,31585778,Efficacy and toxicity outcomes of elderly castrate-resistant prostate cancer patients treated with docetaxel-A pooled analysis of 3 randomized studies.,"BACKGROUND


The current study aims to assess the differences in efficacy and toxicity outcomes according to age among metastatic castrate-resistant prostate cancer patients within a pooled cohort of 3 trials.
METHODS


This study is a pooled analysis of the control arms of 3 prospective studies (NCT00273338; NCT00988208; NCT00519285) which assessed docetaxel/prednisone among patients with metastatic castrate-resistant prostate cancer. Incidence of toxicities between the 2 age groups (<75 years vs. ≥75 years) was assessed through chi-squared testing. Through Kaplan-Meier survival estimates, overall survival was compared between the 2 age groups (<75 years vs. ≥75 years). Multivariate Cox regression analysis was then conducted to evaluate factors potentially affecting overall survival.
RESULTS


A total of 1,212 patients were <75 years old and 388 patients were ≥75 years old were included in the pooled analysis. Comparing both patient subgroups together, older patients were more likely to have any high-grade adverse event (P < 0.001), any fatal adverse events (P = 0.007), any-grade anemia (P < 0.001), and any-grade neutropenia (P < 0.001). Using Kaplan-Meier survival estimates, there was no difference in overall survival between both age groups (P = 0.084). Multivariable Cox regression analysis was additionally conducted to further assess the impact of age on overall survival. There was no difference in overall survival according to age (hazard ratio for age < 75 years vs. age ≥ 75 years: 0.883; 0.738-1.057; P = 0.176).
CONCLUSION


Older patients (≥75 years) have apparently similar survival outcomes compared to younger patients (<75 years). On the other hand, older patients have a higher risk of high-grade toxicities and fatal toxicities compared to younger patients.",2020,"There was no difference in overall survival according to age (hazard ratio for age < 75 years vs. age ≥ 75 years: 0.883; 0.738-1.057; P = 0.176).
","['patients with metastatic castrate-resistant prostate cancer', 'Older patients (≥75 years', 'elderly castrate-resistant prostate cancer patients treated with', '1,212 patients were <75 years old and 388 patients were ≥75 years old were included in the pooled analysis', 'metastatic castrate-resistant prostate cancer patients within a pooled cohort of 3 trials']","['docetaxel', 'docetaxel/prednisone']","['Incidence of toxicities', 'grade neutropenia', 'fatal adverse events', 'risk of high-grade toxicities and fatal toxicities', 'survival outcomes', 'overall survival', 'grade anemia', 'efficacy and toxicity outcomes', 'Efficacy and toxicity outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",1212.0,0.106964,"There was no difference in overall survival according to age (hazard ratio for age < 75 years vs. age ≥ 75 years: 0.883; 0.738-1.057; P = 0.176).
","[{'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Abdel-Rahman', 'Affiliation': 'Department of Oncology, University of Alberta and Cross Cancer Institute, Edmonton, Alberta, Canada. Electronic address: omar.abdelsalam@ahs.ca.'}]",Urologic oncology,['10.1016/j.urolonc.2019.09.004']
266,31984873,Efficacy and Mediators of a Web-Based Media Literacy Intervention for Indoor Tanning Prevention.,"Extant media literacy interventions have been delivered in person, limiting their potential for large scale reach, implementation, and dissemination. Although emerging evidence suggests the interventions can impact behavior, the theoretical mediators that can explain the efficacy remain unknown. This study investigated the efficacy and mediators of a web-based media literacy intervention for reducing indoor tanning behavior among young women. Participants were randomly assigned to one of three conditions: a media literacy intervention with counter argument production, a media literacy intervention with counter story production, or an assessment-only control condition. The outcomes of indoor tanning behavior and intention were evaluated with 3- and 6-month follow-ups. Results indicated significant effects of the web-based intervention on reducing indoor tanning behavior at the follow-ups. Changes in perceived media realism completely mediated the intervention effects on behavior. Perceived media realism, positive and negative outcome expectancies, and collective efficacy partially mediated intervention effects on intention. This study demonstrates the efficacy of a web-based media literacy intervention and the theoretical mechanisms underlying the efficacy. It indicates that by altering perceived media realism, outcome expectancies, and collective efficacy, web-based media literacy interventions could generate behavioral effects.",2020,"Participants were randomly assigned to one of three conditions: a media literacy intervention with counter argument production, a media literacy intervention with counter story production, or an assessment-only control condition.",['young women'],"['media literacy intervention with counter argument production, a media literacy intervention with counter story production, or an assessment-only control condition', 'web-based media literacy intervention', 'Web-Based Media Literacy Intervention']","['Perceived media realism, positive and negative outcome expectancies, and collective efficacy', 'indoor tanning behavior']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0677601', 'cui_str': 'Counter (physical object)'}, {'cui': 'C0033268'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0039295', 'cui_str': 'Tannings'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0247884,"Participants were randomly assigned to one of three conditions: a media literacy intervention with counter argument production, a media literacy intervention with counter story production, or an assessment-only control condition.","[{'ForeName': 'Hyunyi', 'Initials': 'H', 'LastName': 'Cho', 'Affiliation': 'School of Communication, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Chi Chuck', 'Initials': 'CC', 'LastName': 'Song', 'Affiliation': 'Division of Biostatistics, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Dinah', 'Initials': 'D', 'LastName': 'Adams', 'Affiliation': 'Futurety LLC, Columbus, OH, USA.'}]",Journal of health communication,['10.1080/10810730.2020.1712500']
267,32269109,Scrambler therapy improves pain in neuromyelitis optica: A randomized controlled trial.,"OBJECTIVE


To determine whether Scrambler therapy is an effective, acceptable, and feasible treatment of persistent central neuropathic pain in patients with neuromyelitis optica spectrum disorder (NMOSD) and to explore the effect of Scrambler therapy on co-occurring symptoms.
METHODS


We conducted a randomized single-blind, sham-controlled trial in patients with NMOSD who have central neuropathic pain using Scrambler therapy for 10 consecutive weekdays. Pain severity, pain interference, anxiety, depression, and sleep disturbance were assessed at baseline, at the end of treatment, and at the 30- and 60-day follow-up.
RESULTS


Twenty-two patients (11 per arm) were enrolled in and completed this trial. The median baseline numeric rating scale (NRS) pain score decreased from 5.0 to 1.5 after 10 days of treatment with Scrambler therapy, whereas the median NRS score did not significantly decrease in the sham arm. Depression was also reduced in the treatment arm, and anxiety was decreased in a subset of patients who responded to treatment. These symptoms were not affected in the sham arm. The safety profiles were similar between groups.
CONCLUSIONS


Scrambler therapy is an effective, feasible, and safe intervention for central neuropathic pain in patients with NMOSD. Decreasing pain with Scrambler therapy may additionally improve depression and anxiety.
CLINICALTRIALSGOV IDENTIFIER


NCT03452176.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that Scrambler therapy significantly reduces pain in patients with NMOSD and persistent central neuropathic pain.",2020,"The median baseline numeric rating scale (NRS) pain score decreased from 5.0 to 1.5 after 10 days of treatment with Scrambler therapy, whereas the median NRS score did not significantly decrease in the sham arm.","['patients with NMOSD and persistent central neuropathic pain', 'Twenty-two patients (11 per arm) were enrolled in and completed this trial', 'patients with neuromyelitis optica spectrum disorder (NMOSD', 'patients with NMOSD', 'patients with NMOSD who have central neuropathic pain using Scrambler therapy for 10 consecutive weekdays']",['Scrambler therapy'],"['anxiety', 'Pain severity, pain interference, anxiety, depression, and sleep disturbance', 'central neuropathic pain', 'median NRS score', 'Depression', 'depression and anxiety', 'pain', 'median baseline numeric rating scale (NRS) pain score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C4087506', 'cui_str': 'Central neuropathic pain'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027873', 'cui_str': 'Neuromyelitis optica'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C4087506', 'cui_str': 'Central neuropathic pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",22.0,0.37789,"The median baseline numeric rating scale (NRS) pain score decreased from 5.0 to 1.5 after 10 days of treatment with Scrambler therapy, whereas the median NRS score did not significantly decrease in the sham arm.","[{'ForeName': 'Maureen A', 'Initials': 'MA', 'LastName': 'Mealy', 'Affiliation': 'From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA. mmealy1@jhmi.edu.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Kozachik', 'Affiliation': 'From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Cook', 'Affiliation': 'From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Totonis', 'Affiliation': 'From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Ruth Andrea', 'Initials': 'RA', 'LastName': 'Salazar', 'Affiliation': 'From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Jerilyn K', 'Initials': 'JK', 'LastName': 'Allen', 'Affiliation': 'From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Nolan', 'Affiliation': 'From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Smith', 'Affiliation': 'From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Levy', 'Affiliation': 'From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}]",Neurology,['10.1212/WNL.0000000000009370']
268,32267724,"Targeted Retreatment of Incompletely Recovered Chronic Obstructive Pulmonary Disease Exacerbations with Ciprofloxacin. A Double-Blind, Randomized, Placebo-controlled, Multicenter, Phase III Clinical Trial.","Rationale:  Chronic obstructive pulmonary disease (COPD) exacerbations are prone to nonrecovery, but there are no data about the effectiveness of retreatment for these prolonged events. We examined whether further therapy with ciprofloxacin for incompletely resolved COPD exacerbations prolonged the time until the next event. Objectives:  To assess whether incompletely recovered COPD exacerbations benefit from additional treatment with ciprofloxacin, at Day 14. Methods:  In a multicenter, randomized double-blind placebo-controlled trial, we studied retreatment with oral ciprofloxacin 500 mg or matched placebo twice daily for 7 days in patients with Global Initiative for Chronic Obstructive Lung Disease stage II-IV COPD and persistent symptoms and/or serum C-reactive protein ≥8 mg/L initiated 14 (±3) days after an index COPD exacerbation. The primary outcome was the time to the next exacerbation within a 90-day period. Measurements and Main Results:  Among 826 patients screened at four centers, 144 eligible participants with incomplete recovery were randomized to receive ciprofloxacin ( n  = 72) or placebo ( n  = 72). Within 90 days of randomization, 57% of the patients in the ciprofloxacin group and 53% in the placebo group experienced one or more exacerbations. The median time to the next exacerbation was 32.5 days (interquartile range 13-50) in the placebo arm and 34 days (interquartile range 17-62) in the ciprofloxacin arm, which was not significantly different (adjusted hazard ratio, 1.07; 95% confidence interval, 0.68-1.68;  P  = 0.76). No significant differences were seen in quality-of-life scores or lung function between the treatment groups. Conclusions:  In patients with persistent symptoms and/or raised C-reactive protein 14 days after a COPD exacerbation, an additional course of ciprofloxacin resulted in no additional benefit compared with placebo. This suggests that nonrecovered exacerbations are not driven by ongoing bacterial infection and may potentially be targeted with antiinflammatory therapy.Clinical trial registered with www.clinicaltrials.gov (NCT02300220).",2020,"57% of patients in the ciprofloxacin group had experienced 1 or more exacerbations, compared to 53% in the placebo group.","['826 patients screened at 4 centres', '144 eligible participants with incomplete recovery', 'patients with GOLD stage II - IV COPD with persistent symptoms and/or serum C-reactive protein (CRP']","['oral ciprofloxacin 500mg or matched placebo', 'placebo', 'Ciprofloxacin', 'ciprofloxacin', 'Placebo']","['exacerbations', 'median time to the next exacerbation', 'COPD Exacerbations', 'time to the next exacerbation within a 90-day period', 'quality of life scores or lung function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1123173', 'cui_str': 'Ciprofloxacin 500 MG'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",,0.771152,"57% of patients in the ciprofloxacin group had experienced 1 or more exacerbations, compared to 53% in the placebo group.","[{'ForeName': 'Andrew I', 'Initials': 'AI', 'LastName': 'Ritchie', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Simon E', 'Initials': 'SE', 'LastName': 'Brill', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Ben H', 'Initials': 'BH', 'LastName': 'Vlies', 'Affiliation': 'School of Aging and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Lydia J', 'Initials': 'LJ', 'LastName': 'Finney', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Allinson', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Alves-Moreira', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Dexter J', 'Initials': 'DJ', 'LastName': 'Wiseman', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Walker', 'Affiliation': 'School of Aging and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Baker', 'Affiliation': ""Institute of Infection and Immunity, St. George's, University of London, London, United Kingdom.""}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Elkin', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, United Kingdom; and.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mallia', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Law', 'Affiliation': 'Hub for Trials Methodology Research, Medical Research Council Biostatistics Unit, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Gavin C', 'Initials': 'GC', 'LastName': 'Donaldson', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Peter M A', 'Initials': 'PMA', 'LastName': 'Calverley', 'Affiliation': 'School of Aging and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Jadwiga A', 'Initials': 'JA', 'LastName': 'Wedzicha', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201910-2058OC']
269,32268815,"Health-related quality-of-life results from the phase 3 OPTIMISMM study: pomalidomide, bortezomib, and low-dose dexamethasone versus bortezomib and low-dose dexamethasone in relapsed or refractory multiple myeloma.","In the randomized phase-3 OPTIMISMM study, the addition of pomalidomide to bortezomib and low-dose dexamethasone (PVd) resulted in significant improvement in progression-free survival (PFS) in lenalidomide-pretreated patients with relapsed or refractory multiple myeloma (RRMM), including lenalidomide refractory patients. Here, we report health-related quality of life (HRQoL) results from this trial. Patients received PVd or Vd in 21-day cycles until disease progression or discontinuation. HRQoL was assessed using the EORTC QLQ-C30, QLQ-MY20, and EQ-5D-3L instruments on day 1 of each treatment cycle. Mean score changes for global QoL, physical functioning, fatigue, side effects of treatment domains, and EQ-5D-3L index were generally stable over time across treatment arms. The proportion of patients who experienced clinically meaningful worsening in global QoL and other domains of interest was similar. These HRQoL results with PVd along with previously demonstrated improvement in PFS vs Vd continue to support its use in patients with RRMM.",2020,"Mean score changes for global QoL, physical functioning, fatigue, side effects of treatment domains, and EQ-5D-3L index were generally stable over time across treatment arms.","['relapsed or refractory multiple myeloma', 'patients with RRMM', 'lenalidomide-pretreated patients with relapsed or refractory multiple myeloma (RRMM), including lenalidomide refractory patients']","['bortezomib and low-dose dexamethasone (PVd', 'bortezomib, and low-dose dexamethasone versus bortezomib and low-dose dexamethasone']","['progression-free survival (PFS', 'Mean score changes for global QoL, physical functioning, fatigue, side effects of treatment domains, and EQ-5D-3L index', 'HRQoL']","[{'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",,0.101986,"Mean score changes for global QoL, physical functioning, fatigue, side effects of treatment domains, and EQ-5D-3L index were generally stable over time across treatment arms.","[{'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'University Medical Center of Hamburg-Eppendorf, Hamburg, Germany and University Hospital of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Meletios', 'Initials': 'M', 'LastName': 'Dimopoulos', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'University Hospital Hôtel-Dieu, Nantes, France.'}, {'ForeName': 'Munci', 'Initials': 'M', 'LastName': 'Yagci', 'Affiliation': 'Gazi Universitesi Tip Fakultesi Hastanesi, Besevler, Turkey.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Larocca', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Abraham S', 'Initials': 'AS', 'LastName': 'Kanate', 'Affiliation': 'Mary Babb Randolph Cancer Center, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Filiz', 'Initials': 'F', 'LastName': 'Vural', 'Affiliation': 'Ege University Hospital, Izmir, Turkey.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Cascavilla', 'Affiliation': 'Fondazione IRCSS Casa Sollievo Della Sofferenza, San Giovanni Rotundo, Italy.'}, {'ForeName': 'Supratik', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'New Cross Hospital, Wolverhampton, University Of Wolverhampton, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Johnson', 'Affiliation': 'Department of Haematology, Western General Hospital, Edinburgh, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Byeff', 'Affiliation': 'Cancer Center of Central Connecticut, Southington, CT, USA.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Hus', 'Affiliation': 'Samodzielny Publiczny Szpital Nr 1 W Lublinie, Lublin, Poland.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Rodríguez-Otero', 'Affiliation': 'University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Ercan', 'Initials': 'E', 'LastName': 'Muelduer', 'Affiliation': 'Medizinische Universitaet Wien, Vienna, Austria.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Anttila', 'Affiliation': 'Division of Hematology, Helsinki University and Helsinki University Hospital Comprehensive Cancer Center, Helsinki, Finland.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Hayden', 'Affiliation': 'St James Hospital-Cancer Clinical Trials Office, Dublin, Ireland.'}, {'ForeName': 'Maria-Theresa', 'Initials': 'MT', 'LastName': 'Krauth', 'Affiliation': 'Department of Internal Medicine I, Division of Hematology and Hemostaseology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Lucio', 'Affiliation': 'Champalimaud Center for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Hadassah Hospital, Jerusalem, Israel.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Mendeleeva', 'Affiliation': 'National Research Center for Hematology of the Ministry of Healthcare of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'Shien', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': 'Evidera, Waltham, MA, USA.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Bristol Myers Squibb, Summit, NJ, USA.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Grote', 'Affiliation': 'Bristol Myers Squibb, Summit, NJ, USA.'}, {'ForeName': 'Tsvetan', 'Initials': 'T', 'LastName': 'Biyukov', 'Affiliation': 'Celgene International Sàrl, a Bristol Myers Squibb Company, Boudry, Switzerland.'}, {'ForeName': 'Sujith', 'Initials': 'S', 'LastName': 'Dhanasiri', 'Affiliation': 'Celgene International Sàrl, a Bristol Myers Squibb Company, Boudry, Switzerland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Richardson', 'Affiliation': 'Jerome Lipper Multiple Myeloma Center, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.'}]",Leukemia & lymphoma,['10.1080/10428194.2020.1747066']
270,30346186,Modified cognitive behavioral therapy (M-CBT) for cocaine dependence: Development of treatment for cognitively impaired users and results from a Stage 1 trial.,"Cognitive impairments are associated with poor outcomes when treating cocaine dependent patients, but behavioral interventions to mitigate this impact have not been developed. In this Stage 1A/1B treatment development study, several compensatory strategies (e.g., content repetition, daily logs, diaries, visual presentation) were combined to create a modified cognitive behavioral therapy (M-CBT) for treating cocaine dependence. Initially, a select group of therapists, neuropsychology experts, and patients were asked to provide input on early drafts of the treatment manual and companion patient workbook. After an uncontrolled small trial (N = 15) and two rounds of manual development (Stage 1A), a pilot randomized clinical trial (N = 102) of cocaine dependent outpatients with and without cognitive impairments was conducted (Stage 1B). Participants were randomized to M-CBT (N = 52) or CBT (N = 50). Both treatments were individually delivered over 12 weeks with assessments conducted at baseline, end-of-treatment, and 3-month follow-up. The primary outcome was frequency of cocaine use, measured by number of days used in the prior 7 days. Participants in the two treatment groups did not differ significantly on drug use reduction or retention in treatment. However, among participants who completed at least 9 weeks of treatment, those in M-CBT showed a trend toward greater reduction in cocaine use compared to those in the CBT group. M-CBT is feasible for impaired and nonimpaired cocaine dependent participants. However, M-CBT treatment did not show significant superiority over standard CBT in the present sample. (PsycINFO Database Record (c) 2018 APA, all rights reserved).",2018,Participants in the two treatment groups did not differ significantly on drug use reduction or retention in treatment.,"['dependent outpatients with and without cognitive impairments was conducted (Stage 1B', 'cognitively impaired users and results from a Stage 1 trial']","['M-CBT', 'modified cognitive behavioral therapy (M-CBT', 'cocaine', 'CBT', 'Modified cognitive behavioral therapy (M-CBT']","['frequency of cocaine use, measured by number of days used in the prior 7 days']","[{'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0457152', 'cui_str': 'Stage Ib'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.0611411,Participants in the two treatment groups did not differ significantly on drug use reduction or retention in treatment.,"[{'ForeName': 'Efrat', 'Initials': 'E', 'LastName': 'Aharonovich', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Deborah S', 'Initials': 'DS', 'LastName': 'Hasin', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Malka', 'Initials': 'M', 'LastName': 'Stohl', 'Affiliation': 'New York State Psychiatric Institute.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Cannizzaro', 'Affiliation': 'New York State Psychiatric Institute.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Sarvet', 'Affiliation': 'New York State Psychiatric Institute.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Bolla', 'Affiliation': 'Department of Neurology, Bayview Medical Center, Johns Hopkins University.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Carroll', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine.'}, {'ForeName': 'Kamala Greene', 'Initials': 'KG', 'LastName': 'Genece', 'Affiliation': 'Bronx-Lebanon Hospital Center.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000398']
271,32101302,Effect of a Skin Self-monitoring Smartphone Application on Time to Physician Consultation Among Patients With Possible Melanoma: A Phase 2 Randomized Clinical Trial.,"Importance


Melanoma is among the most lethal skin cancers; it has become the fifth most common cancer in the United Kingdom, and incidence rates are rising. Population approaches to reducing incidence have focused on mass media campaigns to promote earlier presentation and potentially improve melanoma outcomes; however, interventions using smartphone applications targeting those with the greatest risk could promote earlier presentation to health care professionals for individuals with new or changing skin lesions.
Objective


To study the effect of a commercially available skin self-monitoring (SSM) smartphone application among individuals with increased risk of melanoma on their decision to seek help for changing skin lesions.
Design, Setting, and Participants


This phase 2 randomized clinical trial was conducted in 12 family practices in Eastern England between 2016 and 2017. A total of 238 participants, aged 18 to 75 years and with an increased risk of melanoma, were identified using a real-time melanoma risk assessment tool in family practice waiting rooms. Analysis was intention to treat. Participants were observed for 12 months, and data analysis was conducted from January to August 2018.
Intervention


The intervention and control groups received a consultation with standard written advice on sun protection and skin cancer detection. The intervention group had an SSM application loaded on their smartphone and received instructions for use and monthly self-monitoring reminders.
Main Outcomes and Measures


The coprimary outcomes were skin consultation rates with family practice physicians and patient intervals, measured as the time between noticing a skin change and consulting with a family practice clinician. Follow-up questionnaires were sent at 6 and 12 months, and consultation rates were extracted from family practice records. Secondary outcomes included skin self-examination benefits and barriers, self-efficacy for consulting without delay, perceived melanoma risk, sun protection habits, and potential harms.
Results


A total of 238 patients were randomized (median [interquartile range] age, 55 [43-65] years, 131 [55.0%] women, 227 [95.4%] white British; 119 [50.0%] randomized to the intervention group). Overall, 51 participants (21.4%) had consultations regarding skin changes during the 12 months of follow-up, and 157 participants (66.0%) responded to at least 1 follow-up questionnaire. There were no significant differences in skin consultation rates (adjusted risk ratio, 0.96; 95% CI, 0.56 to 1.66; P = .89), measures of SSM (adjusted mean difference, 0.08; 95% CI, -0.83 to 1.00; P = .86), or psychological harm (eg, Melanoma Worry Scale: adjusted mean difference, -0.12; 95% CI, -0.56 to 0.31; P = .58).
Conclusions and Relevance


In this study, recruitment, retention, and initial delivery of the intervention were feasible, and this research provided no evidence of harm from the SSM smartphone application. However, no evidence of benefit on skin self-examination or health care consulting was found, and there is no reason at this stage to recommend its implementation in this population at increased risk of melanoma.
Trial Registration


isrctn.org Identifier: ISRCTN16061621.",2020,"Overall, 51 participants (21.4%) had consultations regarding skin changes during the 12 months of follow-up, and 157 participants (66.0%) responded to at least 1 follow-up questionnaire.","['238 participants, aged 18 to 75 years and with an increased risk of melanoma, were identified using a real-time melanoma risk assessment tool in family practice waiting rooms', 'Patients With Possible Melanoma', 'individuals with new or changing skin lesions', 'individuals with increased risk of melanoma', '238 patients were randomized (median [interquartile range] age, 55 [43-65] years, 131 [55.0%] women, 227 [95.4%] white British; 119 [50.0', '12 family practices in Eastern England between 2016 and 2017']","['Skin Self-monitoring Smartphone Application', 'consultation with standard written advice on sun protection and skin cancer detection', 'SSM application loaded on their smartphone and received instructions for use and monthly self-monitoring reminders', 'commercially available skin self-monitoring (SSM) smartphone application']","['skin consultation rates with family practice physicians and patient intervals, measured as the time between noticing a skin change and consulting with a family practice clinician', 'skin consultation rates', 'consultations regarding skin changes', 'Time to Physician Consultation', 'skin self-examination benefits and barriers, self-efficacy for consulting without delay, perceived melanoma risk, sun protection habits, and potential harms', 'measures of SSM']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment (procedure)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0015607', 'cui_str': 'Family Practice'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0037284', 'cui_str': 'Skin lesion (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1278523', 'cui_str': 'White British'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0015607', 'cui_str': 'Family Practice'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1444170', 'cui_str': 'Skin self-examination'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]",238.0,0.143568,"Overall, 51 participants (21.4%) had consultations regarding skin changes during the 12 months of follow-up, and 157 participants (66.0%) responded to at least 1 follow-up questionnaire.","[{'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Walter', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Merel M', 'Initials': 'MM', 'LastName': 'Pannebakker', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Barclay', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Mills', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Saunders', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Murchie', 'Affiliation': 'Institute of Applied Health Science, Centre of Academic Primary Care, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Pippa', 'Initials': 'P', 'LastName': 'Corrie', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Hall', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Burrows', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Jon D', 'Initials': 'JD', 'LastName': 'Emery', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.0001']
272,32101308,Systematic Dementia Screening by Multidisciplinary Team Meetings in Nursing Homes for Reducing Emergency Department Transfers: The IDEM Cluster Randomized Clinical Trial.,"Importance


Dementia is often underdiagnosed in nursing homes (NHs). This potentially results in inappropriate care, and high rates of emergency department (ED) transfers in particular.
Objective


To assess whether systematic dementia screening of NH residents combined with multidisciplinary team meetings resulted in a lower rate of ED transfer at 12 months compared with usual care.
Design, Setting, and Participants


Multicenter, cluster randomized trial with NHs as the unit of randomization. The IDEM (Impact of Systematic Tracking of Dementia Cases on the Rate of Hospitalization in Emergency Care Units) trial took place at 64 public and private NHs in France. Recruitment started on May 1, 2010, and was completed on March 31, 2012. Residents who were aged 60 years or older, had no diagnosed or documented dementia, were not bedridden, had lived in the NH for at least 1 month at inclusion, and had a life expectancy greater than 12 months were included. The residents were followed up for 18 months. The main study analyses were completed on October 14, 2016.
Intervention


Two parallel groups were compared: an intervention group consisting of NHs that set up 2 multidisciplinary team meetings to identify residents with dementia and to discuss an appropriate care plan, and a control group consisting of NHs that continued their usual practice. During the inclusion period of 23 months, all residents of participating NHs who met eligibility criteria were included in the study.
Main Outcomes and Measures


The primary end point (ED transfer) was analyzed at 12 months, but the residents included were followed up for 18 months.
Results


A total of 64 NHs participated in the study and enrolled 1428 residents (mean [SD] age, 84.7 [8.1] years; 1019 [71.3%] female): 599 in the intervention group (32 NHs) and 829 in the control group (32 NHs). The final study visit was completed by 1042 residents (73.0%). The main reason for early discontinuation was death (318 residents [22.7%]). The intervention did not reduce the risk of ED transfers during the 12-month follow-up: the proportion of residents transferred at least once to an ED during the 12-month follow-up was 16.2% in the intervention group vs 12.8% in the control group (odds ratio, 1.32; 95% CI, 0.83-2.09; P = .24).
Conclusions and Relevance


This study failed to demonstrate that systematic screening for dementia in NHs resulted in fewer ED transfers. The findings do not support implementation of multidisciplinary team meetings for systematic dementia screening of all NH residents, beyond the national recommendations for dementia diagnosis, to reduce ED transfers.
Trial Registration


ClinicalTrials.gov Identifier: NCT01569997.",2020,"The intervention did not reduce the risk of ED transfers during the 12-month follow-up: the proportion of residents transferred at least once to an ED during the 12-month follow-up was 16.2% in the intervention group vs 12.8% in the control group (odds ratio, 1.32; 95% CI, 0.83-2.09; P = .24).
","['1042 residents (73.0', 'Residents who were aged 60 years or older, had no diagnosed or documented dementia, were not bedridden, had lived in the NH for at least 1 month at inclusion, and had a life expectancy greater than 12 months were included', 'A total of 64 NHs participated in the study and enrolled 1428 residents (mean [SD] age, 84.7 [8.1] years; 1019 [71.3%] female): 599 in the intervention group (32 NHs) and 829 in the control group (32 NHs', '64 public and private NHs in France', 'Nursing Homes for Reducing Emergency Department Transfers', 'all residents of participating NHs who met eligibility criteria were included in the study']","['NH residents combined with multidisciplinary team meetings', 'intervention group consisting of NHs that set up 2 multidisciplinary team meetings to identify residents with dementia and to discuss an appropriate care plan, and a control group consisting of NHs that continued their usual practice']","['rate of ED transfer', 'risk of ED transfers']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0741453', 'cui_str': 'Bedridden'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517875', 'cui_str': '8.1 (qualifier value)'}, {'cui': 'C0450318', 'cui_str': '1019'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0178916', 'cui_str': 'Care plan (record artifact)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",64.0,0.119132,"The intervention did not reduce the risk of ED transfers during the 12-month follow-up: the proportion of residents transferred at least once to an ED during the 12-month follow-up was 16.2% in the intervention group vs 12.8% in the control group (odds ratio, 1.32; 95% CI, 0.83-2.09; P = .24).
","[{'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rolland', 'Affiliation': 'Gérontopôle de Toulouse, Département de Médecine Interne et Gérontologie Clinique, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Tavassoli', 'Affiliation': 'Gérontopôle de Toulouse, Département de Médecine Interne et Gérontologie Clinique, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Philipe', 'Initials': 'P', 'LastName': 'de Souto Barreto', 'Affiliation': 'Gérontopôle de Toulouse, Département de Médecine Interne et Gérontologie Clinique, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Perrin', 'Affiliation': 'Gérontopôle de Toulouse, Département de Médecine Interne et Gérontologie Clinique, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Laffon de Mazières', 'Affiliation': 'Gérontopôle de Toulouse, Département de Médecine Interne et Gérontologie Clinique, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rapp', 'Affiliation': 'LIRAES (EA 4470) & Chaire AGEINOMIX, Université Paris Descartes Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Hermabessière', 'Affiliation': 'Gérontopôle de Toulouse, Département de Médecine Interne et Gérontologie Clinique, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Tournay', 'Affiliation': 'Unité de Soutien Méthodologique à la Recherche, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': 'Gérontopôle de Toulouse, Département de Médecine Interne et Gérontologie Clinique, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Andrieu', 'Affiliation': 'Gérontopôle de Toulouse, Département de Médecine Interne et Gérontologie Clinique, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.0049']
273,31416344,The Effect of Transcranial Direct Current Stimulation on Inflammation in Older Adults With Knee Osteoarthritis: A Bayesian Residual Change Analysis.,"Transcranial direct current stimulation (tDCS) has demonstrated effectiveness in reducing clinical and experimental measures of pain in patients with chronic pain; however, research examining the mechanisms of action for the effects of tDCS has been lacking. The present study investigated the effect of active tDCS on measures of inflammation and stress. Older adults (aged 50-70 years) with knee osteoarthritis (OA) were randomly assigned to receive daily 20-min sessions of either tDCS ( n  = 20) or sham tDCS ( n  = 20) for 5 consecutive days. Participants provided blood samples at baseline and the end of treatment. The following measures of immune function and stress were collected: interleukin (IL)-6 and 10, tumor necrosis factor-α (TNF-α), C-reactive protein, cortisol, and β-endorphin. Generalized linear modeling evaluated each posttreatment measure as a function of tDCS group, controlling for baseline (measuring residual change, analogous to analysis of covariance). Bayesian statistical inference was used to directly quantify the probability of the effect of active tDCS. IL-6, IL-10, TNF-α, and β-endorphin demonstrated lower levels of stress and inflammation in the active tDCS group. These findings provide preliminary evidence that active (relative to sham) tDCS is associated with reduced levels of inflammation.",2020,"IL-6, IL-10, TNF-α, and β-endorphin demonstrated lower levels of stress and inflammation in the active tDCS group.","['patients with chronic pain', 'Older adults (aged 50-70 years) with knee osteoarthritis (OA', 'Older Adults With Knee Osteoarthritis']","['active tDCS', 'sham tDCS', 'Transcranial Direct Current Stimulation', 'Transcranial direct current stimulation (tDCS', 'tDCS']","['measures of inflammation and stress', 'IL-6, IL-10, TNF-α, and β-endorphin demonstrated lower levels of stress and inflammation', 'blood samples', 'interleukin (IL)-6 and 10, tumor necrosis factor-α (TNF-α), C-reactive protein, cortisol, and β-endorphin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0014242', 'cui_str': 'Endorphins'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]",,0.111423,"IL-6, IL-10, TNF-α, and β-endorphin demonstrated lower levels of stress and inflammation in the active tDCS group.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Suchting', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, UTHealth McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Gabriela D', 'Initials': 'GD', 'LastName': 'Colpo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, UTHealth McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Natalia P', 'Initials': 'NP', 'LastName': 'Rocha', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, UTHealth McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Hyochol', 'Initials': 'H', 'LastName': 'Ahn', 'Affiliation': 'Cizik School of Nursing, University of Texas Health Science Center at Houston, Houston, TX, USA.'}]",Biological research for nursing,['10.1177/1099800419869845']
274,32270774,Comparison of the effect of 1-day and 2-day low residue diets on the quality of bowel preparation before colonoscopy.,"Background/Aim


Low residue diet (LRD) has a similar quality of bowel preparation with clear liquid diet before colonoscopy, but improved patient tolerance. However, the optimal LRD duration is still controversial. In this study, we have compared the effect of a 1-day LRD and 2-day LRD on the quality of bowel preparation and patient tolerance.
Patients and Methods


Our prospective, randomized, single-blind trial, single-blind, trial compared two dietary regimens administered the day before colonoscopy. All patients were administered PEG-ES and simethicone for bowel preparation. The primary outcome measure was bowel preparation quality. The secondary outcome measures were insertion time, withdrawal time, polyp detection rate, patient tolerance, and willingness to use the same diet for bowel preparation again. Bowel preparation quality was evaluated using the Boston bowel preparation scale (BBPS). Patient tolerance was evaluated using a hunger-comfort scale.
Results


There was no significant difference in bowel preparation quality between the 2 groups. The 1-day LRD group had a BBPS score of 6.48 ± 1.59 points, while the 2-day LRD group had a score of 6.42 ± 1.06 points (P > 0.05). The groups reported similar colonoscope insertion times, withdrawal times, polyp detection rates and patient tolerance scores (hunger-comfort scores). The numbers of patients who reported that compliance as easy or very easy were 126 (78.2%) in the 1-day group versus 88 (55.0%) in the 2 day group (P < 0.05) and the numbers who were willing to use the diet again in the future were 154 (95.7%) in the 1-day group versus 131 (81.9%) in the 2 day group (P < 0.05).
Conclusion


LRD duration (1 day or 2 days) had no significant effect on bowel preparation quality. Patients in the 1-day LRD group had higher tolerance and satisfaction levels than patients in the 2-day LRD group. However, overall satisfaction was higher with the 1-day LRD group than with the 2-day LRD group.",2020,"The groups reported similar colonoscope insertion times, withdrawal times, polyp detection rates and patient tolerance scores (hunger-comfort scores).",[],"['Low residue diet (LRD', '1-day and 2-day low residue diets', '1-day LRD and 2-day LRD']","['overall satisfaction', 'Boston bowel preparation scale (BBPS', 'BBPS score', 'insertion time, withdrawal time, polyp detection rate, patient tolerance, and willingness to use the same diet for bowel preparation again', 'Patient tolerance', 'colonoscope insertion times, withdrawal times, polyp detection rates and patient tolerance scores (hunger-comfort scores', 'bowel preparation quality', 'tolerance and satisfaction levels', 'quality of bowel preparation', 'Bowel preparation quality']",[],"[{'cui': 'C0425404', 'cui_str': 'Low residue diet'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C4302285', 'cui_str': 'BBPS - Boston bowel preparation scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0180022', 'cui_str': 'Colonoscope'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.099055,"The groups reported similar colonoscope insertion times, withdrawal times, polyp detection rates and patient tolerance scores (hunger-comfort scores).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Jiao', 'Affiliation': 'Department of Gastroenterology, The Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Junmin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, The Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Gastroenterology, The Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Xinying', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Gastroenterology, The Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Department of Gastroenterology, The Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Gastroenterology, The Third Hospital of Hebei Medical University, Shijiazhuang, China.'}]",Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association,['10.4103/sjg.SJG_471_19']
275,32270252,Treatments of osteoporosis increase bone material strength index in patients with low bone mass.,"Effects on bone material properties of two-year antiosteoporotic treatment were assessed using in vivo impact microindentation (IMI) in patients with low bone mineral density (BMD) values. Antiresorptive treatment, in contrast to vitamin D ± calcium treatment alone, induced BMD-independent increases in bone material strength index, measured by IMI, the magnitude of which depended on pretreatment values.
INTRODUCTION


Bone material strength index (BMSi), measured by IMI in vivo, is reduced in patients with fragility fractures, but there is no information about changes in values during long-term therapy. In the present study, we assessed changes in BMSi in patients receiving antiosteoporotic treatments for periods longer than 12 months.
METHODS


We included treatment-naive patients with low bone mass who had a BMSi measurement with OsteoProbe® at presentation and consented to a repeat measurement after treatment.
RESULTS


We studied 54 patients (34 women), median age 58 years, of whom 30 were treated with bisphosphonates or denosumab (treatment group) and 24 with vitamin D ± calcium alone (control group). There were no differences in clinical characteristics between the two groups with the exception of a higher number of previous fragility fractures in the treatment group. Baseline hip BMD and BMSi values were lower in the treatment group. After 23.1 ± 6.6 months, BMSi increased significantly in the treatment group (82.4 ± 4.3 vs 79.3 ± 4.1; p < 0.001), but did not change in the control group (81.5 ± 5.2 vs 82.2 ± 4.1; p = 0.35). Changes in BMSi with antiresorptives were inversely related with baseline values (r = - 0.43; p = 0.02) but not with changes in BMD. Two patients in the control group with large decreases in BMSi values sustained incident fractures.
CONCLUSION


In patients at increased fracture risk, antiresorptive treatments induced BMD-independent increases in BMSi values, the magnitude of which depended on pretreatment values.",2020,There were no differences in clinical characteristics between the two groups with the exception of a higher number of previous fragility fractures in the treatment group.,"['patients receiving antiosteoporotic treatments for periods longer than 12\xa0months', 'patients with fragility fractures', 'patients with low bone mass', 'treatment group) and 24 with', 'patients with low bone mineral density (BMD)\xa0values', 'naive patients with low bone mass who had a BMSi measurement with OsteoProbe® at presentation and consented to a repeat measurement after treatment', '54 patients (34 women), median age 58\xa0years, of whom 30 were treated with']","['vitamin D ± calcium alone (control group', 'bisphosphonates or denosumab']","['changes in BMSi', 'bone material properties', 'Baseline hip BMD and BMSi values', 'vivo impact microindentation (IMI', 'BMSi values', 'previous fragility fractures', 'BMSi', 'bone material strength index', 'osteoporosis increase bone material strength index', 'BMSi values sustained incident fractures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4760971', 'cui_str': 'Fragility fracture'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0340305', 'cui_str': 'Myocardial Infarction, Inferior Wall'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C4760971', 'cui_str': 'Fragility fracture'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]",54.0,0.0374018,There were no differences in clinical characteristics between the two groups with the exception of a higher number of previous fragility fractures in the treatment group.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schoeb', 'Affiliation': 'Center for Bone Quality, Department of Medicine, Division Endocrinology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Malgo', 'Affiliation': 'Center for Bone Quality, Department of Medicine, Division Endocrinology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'J J M', 'Initials': 'JJM', 'LastName': 'Peeters', 'Affiliation': 'Center for Bone Quality, Department of Medicine, Division Endocrinology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Winter', 'Affiliation': 'Center for Bone Quality, Department of Medicine, Division Endocrinology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Papapoulos', 'Affiliation': 'Center for Bone Quality, Department of Medicine, Division Endocrinology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'Appelman-Dijkstra', 'Affiliation': 'Center for Bone Quality, Department of Medicine, Division Endocrinology, Leiden University Medical Center, Leiden, The Netherlands. n.m.appelman-dijkstra@lumc.nl.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05375-3']
276,32271271,Visual and refractive outcomes and glistenings occurrence after implantation of 2 hydrophobic acrylic aspheric monofocal IOLs.,"PURPOSE


To compare the Clareon IOL with the Tecnis PCB00 IOL in terms of visual performance, refractive outcomes, glistenings occurrence, and quality-of-life outcomes.
SETTING


Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.
DESIGN


Single-center, single-masked, prospective, randomized controlled trial.
METHODS


One hundred thirty-nine patients with bilateral cataracts were randomized to receive the Clareon (C IOL) or Tecnis (T IOL) IOL. Visual acuity, refraction, central corneal thickness (CCT), endothelial cell loss, contrast sensitivity, mesopic gap acuity, evaluation of glistenings, and rates of perioperative and postoperative complications were recorded. Quality-of-life outcomes were measured with the EuroQOL-5 dimensions questionnaire and the patient-reported outcome measures (PROMs) questionnaire. Optimized A-constants were available for the T IOL but not for the C IOL.
RESULTS


Seventy-one patients (140 eyes) received the C IOLs and 68 patients (134 eyes) received the T IOLs. Data were analyzed for the first implanted eye. At 12 months, mean uncorrected distance visual acuity (logarithm of the minimum angle of resolution) was 0.02 ± 0.10 and 0.01 ± 0.08 (mean ± SD; P = .49; 95% CI, -0.02 to 0.04) in the C IOL and T IOL groups, respectively. Corrected distance visual acuity was -0.02 ± 0.09 and -0.03 ± 0.06, respectively (P = .45; 95% CI, -0.02 to 0.04). The increase in CCT was 14 ± 19 and 16 ± 28 μm, respectively (P = .63; 95% CI, -10.16 to 6.16). Mean absolute refraction spherical equivalent error from target refraction was 0.41 ± 0.28 for the C IOL and 0.25 ± 0.2 for the T IOL groups (P = .002; 95% CI, 0.08 to 0.24). Glistenings were minimal (median grade 0), with no difference in grades between groups (P = .2). PROMs improved postoperatively and were similar in both groups.
CONCLUSIONS


There were no differences in visual outcomes between the Clareon IOL and Tecnis PCB00 IOL. Glistenings were rarely observed in either IOL with no difference in grades. There was no difference in perioperative or postoperative complications. Surgeon optimization of the A-constant for the Clareon IOL is recommended.",2020,"At 12 months, mean uncorrected distance visual acuity (logarithm of the minimum angle of resolution) was 0.02+/-0.10 and 0.01+/-0.08 (","['One hundred thirty-nine patients with bilateral cataracts', ""Guy's and St Thomas' NHS Foundation Trust, London, England""]","['Clareon (C IOL) or Tecnis (T IOL) IOL', 'C IOL', '2 monofocal, aspheric, hydrophobic acrylic IOLs', 'Clareon intraocular lens (IOL) with the Tecnis PCB00 IOL']","['CCT', 'mean uncorrected distance visual acuity (logarithm of the minimum angle of resolution', 'EuroQOL-5 Dimension questionnaire', 'visual outcomes', 'Visual acuity, refraction, central corneal thickness (CCT), endothelial cell loss, contrast sensitivity, and mesopic gap acuity, evaluation of glistenings and rates of perioperative and postoperative complications', 'Corrected visual acuity', 'Mean absolute refraction spherical equivalent error from target refraction', 'visual performance, refractive outcomes, glistenings occurrence, and quality-of-life outcomes', 'perioperative or postoperative complications', 'Quality-of-life outcomes']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521707', 'cui_str': 'Bilateral cataracts'}, {'cui': 'C0018408', 'cui_str': 'Guyana'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0598629', 'cui_str': 'Hydrophobicity'}, {'cui': 'C0440181', 'cui_str': 'Acrylic dental material'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]","[{'cui': 'C4049005', 'cui_str': 'Cataract, total congenital with posterior sutural opacities in Heterozygotes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",139.0,0.274534,"At 12 months, mean uncorrected distance visual acuity (logarithm of the minimum angle of resolution) was 0.02+/-0.10 and 0.01+/-0.08 (","[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Stanojcic', 'Affiliation': ""From the Department of Ophthalmology, Guy's and St Thomas' NHS Foundation Trust (Stanojcic, O'Brart, Wagh, Azan, Bhogal, Robbie), King's College London (Stanojcic, O'Brart, Li), Centre for Applied Vision Research, School of Health Sciences, University of London (Hull), London, United Kingdom.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'OʼBrart', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hull', 'Affiliation': ''}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Wagh', 'Affiliation': ''}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Azan', 'Affiliation': ''}, {'ForeName': 'Mani', 'Initials': 'M', 'LastName': 'Bhogal', 'Affiliation': ''}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Robbie', 'Affiliation': ''}, {'ForeName': 'Ji-Peng Olivia', 'Initials': 'JO', 'LastName': 'Li', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000201']
277,32255266,A Randomized Double-Blind Controlled Pilot Study Comparing Leucocyte-Rich Platelet-Rich Plasma and Corticosteroid in Caudal Epidural Injection for Complex Chronic Degenerative Spinal Pain.,"OBJECTIVES


To compare the efficacy and safety between leucocyte-rich platelet-rich plasma (LR-PRP) and corticosteroid in fluoroscopically guided caudal epidural injection for patients with complex chronic lumbar spinal pain.
STUDY DESIGN


A prospective randomized controlled double-blinded study.
METHODS


Fifty eligible patients with complex chronic degenerative spinal pain were randomly assigned with a 1:1 allocation ratio to receive caudal epidural injection of corticosteroid (triamcinolone acetonide, 60 mg) or LR-PRP (isolated from 60 mL autologous blood) under fluoroscopic guidance. Levels of low back pain, quality of life, and complications (or adverse effects) were evaluated at 1, 3, and 6 months after treatment. Pain levels and quality of life were assessed using the VAS and Short Form 36-Item Health Survey (SF-36), respectively.
RESULTS


No significant difference was shown at baseline between the 2 groups. Compared with the pretreatment values, there were significant reductions in the VAS score in both groups. A significantly lower VAS score at 1-month follow-up was detected in patients who received corticosteroid injection. However, the scores were lower in the LR-PRP group at 3- and 6-month follow-up. SF-36 responses at 6 months showed significant improvement in all domains in the LR-PRP group. There were no complications or adverse effects related to treatment at 6-month follow-up in either group.
CONCLUSIONS


Both autologous LR-PRP and corticosteroid for caudal epidural injections under fluoroscopic guidance are equally safe and therapeutically effective in patients with complex chronic lumbar spinal pain. However, LR-PRP is superior to corticosteroid for a longer pain-relieving effect and improvement in quality of life.",2020,Both autologous LR-PRP and corticosteroid for caudal epidural injections under fluoroscopic guidance are equally safe and therapeutically effective in patients with complex chronic lumbar spinal pain.,"['patients with complex chronic lumbar spinal pain', 'Complex Chronic Degenerative Spinal Pain', 'Fifty eligible patients with complex chronic degenerative spinal pain']","['autologous LR-PRP and corticosteroid', 'caudal epidural injection of corticosteroid (triamcinolone acetonide, 60mg) or LR-PRP (isolated from 60 ml autologous blood) under fluoroscopic guidance', 'leucocyte-rich platelet-rich plasma (LR-PRP) and corticosteroid', 'Leucocyte-Rich Platelet-Rich Plasma and Corticosteroid']","['VAS score', 'Pain levels and quality of life', 'Levels of low back pain, quality of life, and complications (or adverse effects', 'quality of life', 'SF-36 questionnaires', 'visual analog scale (VAS) and short form SF-36, respectively', 'complications or adverse effects', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0423673', 'cui_str': 'Pain in spine'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0032027', 'cui_str': 'Pityriasis rubra pilaris'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0394837', 'cui_str': 'Local anesthetic sacral epidural block'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0560563', 'cui_str': 'Fluoroscopic guidance'}, {'cui': 'C0023516', 'cui_str': 'Leukocyte'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",50.0,0.168039,Both autologous LR-PRP and corticosteroid for caudal epidural injections under fluoroscopic guidance are equally safe and therapeutically effective in patients with complex chronic lumbar spinal pain.,"[{'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Ruiz-Lopez', 'Affiliation': 'Clinica Vertebra, Barcelona Spine and Pain Surgery Center, Unit of MISS, Barcelona, Spain.'}, {'ForeName': 'Yu-Chuan', 'Initials': 'YC', 'LastName': 'Tsai', 'Affiliation': 'Department of Anesthesiology and Center of Pain Management, E-Da Cancer Hospital, Kaohsiung, Taiwan.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12893']
278,31897483,Multinutrient Supplementation Increases Collagen Synthesis during Early Wound Repair in a Randomized Controlled Trial in Patients with Inguinal Hernia.,"BACKGROUND


Inguinal hernia disease is associated with an imbalanced collagen metabolism. Surgical stress has a negative impact on nutrients important for collagen synthesis.
OBJECTIVE


We hypothesized that supplementation with a combination of nutrients would enhance collagen biosynthesis in inguinal hernia disease patients when undergoing hernia repair.
METHODS


In this exploratory randomized controlled trial, 21 men (age: 55.2 ± 2.8 y; BMI: 25.0 ± 0.7 kg/m2) scheduled for Lichtenstein inguinal hernia repair were assigned to multinutrient supplementation (n = 10; multinutrient group) or no multinutrient supplementation (n = 11; control group). The multinutrient group received 14 g l-arginine, 14 g l-glutamine, 1250 mg vitamin C, and 55 mg zinc daily starting 14 d before surgery and ending 14 d after surgery. The multinutrient and control groups received high-quality protein to ensure a daily intake of 1.5 g protein/kg. Collagen biosynthesis was measured by the biomarkers type I procollagen propeptide (CICP), type III procollagen propeptide (PRO-C3), and type V procollagen propeptide (PRO-C5) in the sera on days -14, 0, and 1, and in the wound fluids on postoperative days 1 and 2. Compliance was recorded after the 28-d intervention period.
RESULTS


Serum PRO-C5 concentrations decreased (P < 0.05) postoperatively in the control but not the multinutrient group. Neither CICP nor PRO-C3 serum concentrations differed significantly between the 2 groups. In wound fluid, the CICP concentrations increased (P < 0.05) from days 1 to 2 in the multinutrient group and were 49% higher (P = 0.10) than those in the control group on day 2. Wound fluid concentrations PRO-C3 and PRO-C5 showed no significant time or group differences. The 28-d compliance was similar (P = 0.27) in the 2 groups.
CONCLUSION


Oral supplementation with arginine, glutamine, vitamin C, and zinc augment collagen synthesis during the first 2 d after inguinal hernia repair. This trial was registered at clinicaltrials.gov as NCT03221686.",2020,"RESULTS


Serum PRO-C5 concentrations decreased (P < 0.05) postoperatively in the control but not the multinutrient group.","['21 men (age: 55.2\xa0±\xa02.8 y; BMI: 25.0\xa0±\xa00.7\xa0kg/m2) scheduled for Lichtenstein inguinal hernia repair', 'Patients with Inguinal Hernia', 'inguinal hernia disease patients when undergoing hernia repair']","['high-quality protein', '14\xa0g l-arginine, 14\xa0g l-glutamine, 1250\xa0mg vitamin C', 'Multinutrient Supplementation', 'multinutrient supplementation (n\xa0=\xa010; multinutrient group) or no multinutrient supplementation', 'arginine, glutamine, vitamin C, and zinc']","['CICP concentrations', 'Collagen Synthesis', 'biomarkers type I procollagen propeptide (CICP), type III procollagen propeptide (PRO-C3), and type V procollagen propeptide (PRO-C5', 'CICP nor PRO-C3 serum concentrations', 'Compliance', 'Serum PRO-C5 concentrations', 'Collagen biosynthesis']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019294', 'cui_str': 'Hernia, Inguinal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0019328', 'cui_str': 'Hernia Repair'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1318184', 'cui_str': '14G'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C4517554', 'cui_str': 'One thousand two hundred and fifty'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0041457', 'cui_str': 'Procollagen Type I'}, {'cui': 'C0033240', 'cui_str': 'Type III Procollagen'}, {'cui': 'C0071997', 'cui_str': 'C3 Precursor'}, {'cui': 'C0033243', 'cui_str': 'Procollagen Type V'}, {'cui': 'C0645500', 'cui_str': 'Precursor C5'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",,0.164561,"RESULTS


Serum PRO-C5 concentrations decreased (P < 0.05) postoperatively in the control but not the multinutrient group.","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Kjaer', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Amalie Kruse Sigersted', 'Initials': 'AKS', 'LastName': 'Frederiksen', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Neel Ingemann', 'Initials': 'NI', 'LastName': 'Nissen', 'Affiliation': 'Nordic Bioscience A/S, Herlev, Denmark.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Willumsen', 'Affiliation': 'Nordic Bioscience A/S, Herlev, Denmark.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'van Hall', 'Affiliation': 'Clinical Metabolomics Core Facility, Department of Clinical Biochemistry, Rigshospitalet, and Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars Nannestad', 'Initials': 'LN', 'LastName': 'Jorgensen', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens Rikardt', 'Initials': 'JR', 'LastName': 'Andersen', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Magnus S', 'Initials': 'MS', 'LastName': 'Ågren', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}]",The Journal of nutrition,['10.1093/jn/nxz324']
279,31796025,Biannual versus annual mass azithromycin distribution and malaria seroepidemiology among preschool children in Niger: a sub-study of a cluster randomized trial.,"BACKGROUND


Biannual mass azithromycin administration to preschool children reduces all-cause mortality, but the mechanism for the effect is not understood. Azithromycin has activity against malaria parasites, and malaria is a leading cause of child mortality in the Sahel. The effect of biannual versus annual azithromycin distribution for trachoma control on serological response to merozoite surface protein 1 (MSP-1 19 ), a surrogate for malaria incidence, was evaluated among children in Niger.
METHODS


Markers of malaria exposure were measured in two arms of a factorial randomized controlled trial designed to evaluate targeted biannual azithromycin distribution to children under 12 years of age compared to annual azithromycin to the entire community for trachoma control (N = 12 communities per arm). Communities were treated for 36 months (6 versus 3 distributions). Dried blood spots were collected at 36 months among children ages 1-5 years, and MSP-1 19  antibody levels were assessed using a bead-based multiplex assay to measure malaria seroprevalence.
RESULTS


Antibody results were available for 991 children. MSP-1 19  seropositivity was 62.7% in the biannual distribution arm compared to 68.7% in the annual arm (prevalence ratio 0.91, 95% CI 0.83 to 1.00). Mean semi-quantitative antibody levels were lower in the biannual distribution arm compared to the annual arm (mean difference - 0.39, 95% CI - 0.05 to - 0.72).
CONCLUSIONS


Targeted biannual azithromycin distribution was associated with lower malaria seroprevalence compared to that in a population that received annual distribution. Trial Registration Clinicaltrials.gov NCT00792922.",2019,"Mean semi-quantitative antibody levels were lower in the biannual distribution arm compared to the annual arm (mean difference - 0.39, 95% CI - 0.05 to - 0.72).
","['991 children', 'preschool children in Niger', 'preschool children', 'children in Niger', 'distribution to children under 12\xa0years of age compared to annual azithromycin to the entire community for trachoma control (N\u2009=\u200912 communities per arm', 'Markers of malaria exposure']","['azithromycin', 'Azithromycin', 'biannual azithromycin', 'biannual versus annual azithromycin']","['MSP-1 19  seropositivity', 'Mean semi-quantitative antibody levels', 'malaria seroprevalence', 'Dried blood spots']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0028074', 'cui_str': 'Republic of Niger'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0040592', 'cui_str': 'Egyptian Ophthalmia'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}]","[{'cui': 'C0169904', 'cui_str': 'PFM-PSCP'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0522525', 'cui_str': 'Semi-quantitative (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0600367', 'cui_str': 'Seroprevalence'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}]",991.0,0.11671,"Mean semi-quantitative antibody levels were lower in the biannual distribution arm compared to the annual arm (mean difference - 0.39, 95% CI - 0.05 to - 0.72).
","[{'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, CA, USA. catherine.oldenburg@ucsf.edu.'}, {'ForeName': 'Abdou', 'Initials': 'A', 'LastName': 'Amza', 'Affiliation': 'Programme FSS/Université Abdou Moumouni de Niamey, Programme Nationale des Soins Oculaire, Niamey, Niger.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Cooley', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Centers for Disease Prevention and Control, Atlanta, GA, USA.'}, {'ForeName': 'Boubacar', 'Initials': 'B', 'LastName': 'Kadri', 'Affiliation': 'Programme FSS/Université Abdou Moumouni de Niamey, Programme Nationale des Soins Oculaire, Niamey, Niger.'}, {'ForeName': 'Beido', 'Initials': 'B', 'LastName': 'Nassirou', 'Affiliation': 'Programme FSS/Université Abdou Moumouni de Niamey, Programme Nationale des Soins Oculaire, Niamey, Niger.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Arnold', 'Affiliation': 'Department of Epidemiology, University of California, Berkeley, Berkeley, CA, USA.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Rosenthal', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Kieran S', 'Initials': 'KS', 'LastName': ""O'Brien"", 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Sheila K', 'Initials': 'SK', 'LastName': 'West', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Wilmer Eye Institute, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'Clinical Research Unit, Department of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Martin', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Centers for Disease Prevention and Control, Atlanta, GA, USA.'}]",Malaria journal,['10.1186/s12936-019-3033-2']
280,32252101,Addition of Caffeine to a Carbohydrate Feeding Strategy Prior to Intermittent Exercise.,"The ergogenic effect of caffeine is well established, although no investigations providing a high carbohydrate feeding strategy (pre-exercise meal=2 g/kg BM) co-ingested with caffeine exist for soccer. This investigation examines the effect of caffeine in addition to a pre-exercise carbohydrate meal and drink mid-way through a soccer simulation. Eight recreational soccer players completed an 85-minute soccer simulation followed by an exercise capacity test (Yo-yo Intermittent Endurance test level 2) on two occasions. Prior to exercise participants consumed a high carbohydrate meal, with placebo or 5 mg/kg BM -1  caffeine. No significant performance effect was identified (p=0.099) despite a 12.8% (109 m) improvement in exercise capacity following caffeine. Rates of carbohydrate and fat oxidation did not differ between conditions and nor were differences apparent for plasma glucose, fatty acids, glycerol, β-hydroxybutyrate (p>0.05). However, an increase in lactate was observed for caffeine (p=0.039). A significant condition effect on rating of perceived exertion was identified (p<0.001), with the overall mean for the protocol lowered to 11.7±0.9 au for caffeine compared to 12.8±1.3 au. Caffeine supplementation with a carbohydrate feeding strategy failed to affect metabolic and metabolite responses, although reductions in perception of exercise were observed. While a 12.8% increase in exercise capacity was noted the findings were not significant, possibly due to the small sample size.",2020,"Rates of carbohydrate and fat oxidation did not differ between conditions and nor were differences apparent for plasma glucose, fatty acids, glycerol, β-hydroxybutyrate (p>0.05).",['Eight recreational soccer players'],"['Caffeine', 'caffeine', '85-minute soccer simulation followed by an exercise capacity test (Yo-yo Intermittent Endurance test level 2', 'Caffeine supplementation', 'high carbohydrate meal, with placebo or 5\u2009mg/kg BM -1  caffeine']","['metabolic and metabolite responses', 'plasma glucose, fatty acids, glycerol, β-hydroxybutyrate (p>0.05', 'Rates of carbohydrate and fat oxidation', 'perception of exercise', 'performance effect', 'exercise capacity', 'lactate', 'rating of perceived exertion']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",,0.0329557,"Rates of carbohydrate and fat oxidation did not differ between conditions and nor were differences apparent for plasma glucose, fatty acids, glycerol, β-hydroxybutyrate (p>0.05).","[{'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Hulton', 'Affiliation': 'Department of Nutritional Sciences, University of Surrey, Guildford, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Kaio', 'Initials': 'K', 'LastName': 'Vitzel', 'Affiliation': 'School of Heath Science, Massey University, Palmerston North, New Zealand.'}, {'ForeName': 'Dominic A', 'Initials': 'DA', 'LastName': 'Doran', 'Affiliation': 'Research Institute of Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Don P M', 'Initials': 'DPM', 'LastName': 'MacLaren', 'Affiliation': 'Research Institute of Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, United Kingdom of Great Britain and Northern Ireland.'}]",International journal of sports medicine,['10.1055/a-1121-7817']
281,32027763,"From ""4Rs and 2Ss"" to ""Amaka Amasanyufu"" (Happy Families): Adapting a U.S.-based Evidence-Based Intervention to the Uganda Context.","In Uganda, one in five children presents mental health challenges, including disruptive behavior disorders (DBDs). DBDs can persist through adulthood and result in negative outcomes. Effective interventions for DBDs have been developed and tested in high-poverty communities in developed countries. Yet, most African countries, such as Uganda, lack such interventions. This paper describes the adaptation process of an evidence-based intervention of U.S. origin to optimize fit to context with intervention fidelity, as part of a randomized trial conducted with youth that exhibit behavioral challenges and their caregivers in 30 schools in Uganda. The process involved: initial meetings with headteachers and teachers to introduce the study and the main concepts of the intervention; initial manual review focusing on 4Rs and 2Ss content by the Uganda team; engagement of community stakeholders for additional feedback on content and cultural relevance; final revision of the manual; and collection of children's drawings for the illustration of the manual. This paper describes both similarities and differences between the original and adapted intervention content and methods of delivery. The findings also highlight the importance of involving community stakeholders in the adaptation process.",2020,"This paper describes the adaptation process of an evidence-based intervention of U.S. origin to optimize fit to context with intervention fidelity, as part of a randomized trial conducted with youth that exhibit behavioral challenges and their caregivers in 30 schools in Uganda.",['youth that exhibit behavioral challenges and their caregivers in 30 schools in Uganda'],[],[],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}]",[],[],,0.0200189,"This paper describes the adaptation process of an evidence-based intervention of U.S. origin to optimize fit to context with intervention fidelity, as part of a randomized trial conducted with youth that exhibit behavioral challenges and their caregivers in 30 schools in Uganda.","[{'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Sensoy Bahar', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Byansi', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Apollo', 'Initials': 'A', 'LastName': 'Kivumbi', 'Affiliation': 'International Center for Child Health and Development, Uganda Field Office, Masaka, Uganda.'}, {'ForeName': 'Phionah', 'Initials': 'P', 'LastName': 'Namatovu', 'Affiliation': 'International Center for Child Health and Development, Uganda Field Office, Masaka, Uganda.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Kiyingi', 'Affiliation': 'International Center for Child Health and Development, Uganda Field Office, Masaka, Uganda.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'McKay', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Thabani', 'Initials': 'T', 'LastName': 'Nyoni', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, MO.'}]",Family process,['10.1111/famp.12525']
282,31558624,"Regular, sustained-release morphine for chronic breathlessness: a multicentre, double-blind, randomised, placebo-controlled trial.","INTRODUCTION


Morphine may decrease the intensity of chronic breathlessness but data from a large randomised controlled trial (RCT) are lacking. This first, large, parallel-group trial aimed to test the efficacy and safety of regular, low-dose, sustained-release (SR) morphine compared with placebo for chronic breathlessness.
METHODS


Multisite (14 inpatient and outpatient cardiorespiratory and palliative care services in Australia), parallel-arm, double-blind RCT. Adults with chronic breathlessness (modified Medical Research Council≥2) were randomised to 20 mg daily oral SR morphine and laxative (intervention) or placebo and placebo laxative (control) for 7 days. Both groups could take ≤6 doses of 2.5 mg, ' as needed ', immediate-release morphine (≤15 mg/24 hours) as required by the ethics review board. The primary endpoint was change from baseline in intensity of  breathlessness now  (0-100 mm visual analogue scale; two times per day diary) between groups. Secondary endpoints included:  worst ,  best  and  average breathlessness ; unpleasantness of  breathlessness now , fatigue; quality of life; function; and harms.
RESULTS


Analysed by intention-to-treat, 284 participants were randomised to morphine (n=145) or placebo (n=139). There was no difference between arms for the primary endpoint (mean difference -0.15 mm (95% CI -4.59 to 4.29; p=0.95)), nor secondary endpoints. The placebo group used more doses of oral morphine solution during the treatment period (mean 8.7 vs 5.8 doses; p=0.001). The morphine group had more constipation and nausea/vomiting. There were no cases of respiratory depression nor obtundation.
CONCLUSION


No differences were observed between arms for breathlessness, but the intervention arm used less rescue immediate-release morphine.
TRIAL REGISTRATION NUMBER


ACTRN12609000806268.",2020,"There was no difference between arms for the primary endpoint (mean difference -0.15 mm (95% CI -4.59 to 4.29; p=0.95)), nor secondary endpoints.","['284 participants were randomised to', 'Multisite (14 inpatient and outpatient cardiorespiratory and palliative care services in Australia', 'chronic breathlessness', 'Adults with chronic breathlessness (modified Medical Research Council≥2']","['morphine', 'Regular, sustained-release morphine', '20\u2009mg daily oral SR morphine and laxative (intervention) or placebo and placebo laxative (control', 'placebo', 'Morphine', 'regular, low-dose, sustained-release (SR) morphine', 'oral morphine solution']","['constipation and nausea/vomiting', 'intensity of chronic breathlessness', '  worst ,  best  and  average breathlessness ; unpleasantness of  breathlessness now , fatigue; quality of life; function; and harms', 'intensity of  breathlessness now  (0-100\u2009mm visual analogue scale', 'rescue immediate-release morphine', 'respiratory depression nor obtundation']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0282090', 'cui_str': 'Laxatives'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034380'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}, {'cui': 'C0085628', 'cui_str': 'Stupor'}]",284.0,0.805557,"There was no difference between arms for the primary endpoint (mean difference -0.15 mm (95% CI -4.59 to 4.29; p=0.95)), nor secondary endpoints.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Currow', 'Affiliation': 'IMPACCT, Faculty of Heath, University of Technology Sydney, Sydney, New South Wales, Australia david.currow@uts.edu.au.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Louw', 'Affiliation': 'McCloud Consulting Group, Sydney, New South Wales, Australia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'McCloud', 'Affiliation': 'McCloud Consulting Group, Sydney, New South Wales, Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Fazekas', 'Affiliation': 'IMPACCT, Faculty of Heath, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Plummer', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Christine F', 'Initials': 'CF', 'LastName': 'McDonald', 'Affiliation': 'Respiratory and Sleep Medicine, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Agar', 'Affiliation': 'IMPACCT, Faculty of Heath, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Clark', 'Affiliation': 'Northern Sydney Local Health District, Saint Leonards, New South Wales, Australia.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'McCaffrey', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Magnus Pär', 'Initials': 'MP', 'LastName': 'Ekström', 'Affiliation': 'IMPACCT, Faculty of Heath, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Thorax,['10.1136/thoraxjnl-2019-213681']
283,32264715,Clinical Outcomes and Quality of Life With an Ambulatory Counterpulsation Pump in Advanced Heart Failure Patients: Results of the Multicenter Feasibility Trial.,"BACKGROUND


The NuPulseCV intravascular ventricular assist system (iVAS) provides extended duration ambulatory counterpulsation via a durable pump placed through the distal subclavian artery.
METHODS


We performed a prospective, single-arm, multicenter, US Food and Drug Administration-approved feasibility trial of iVAS therapy as a bridge to transplant or decision following the FIH (First-In-Human) trial.
RESULTS


Forty-seven patients were enrolled, and 45 patients (median 61 years old, 37 males, and 30 listed on United Network of Organ Sharing) received iVAS support for median 44 (25-87) days. There were no intraoperative complications. Success was defined as survival or transplant on iVAS therapy free from disabling stroke. Outcome success at 30 days (the primary end point of this study) and at 6 months was 89% and 80%, respectively. During 6 months of iVAS support, 2 patients died and 2 patients experienced disabling neurological dysfunction. Six-minute walk distance, 2-minute step test, and Kansas City Cardiomyopathy Questionnaire score improved during 4-week iVAS support.
CONCLUSIONS


This feasibility trial demonstrated promising short-term outcomes of iVAS therapy with improved functional capacity and quality of life during the therapy. Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02645539.",2020,"Six-minute walk distance, 2-minute step test, and Kansas City Cardiomyopathy Questionnaire score improved during 4-week iVAS support.
","['Advanced Heart Failure Patients', 'Forty-seven patients were enrolled, and 45 patients (median 61 years old, 37 males, and 30 listed on United Network of Organ Sharing) received iVAS support for median 44 (25-87) days']","['iVAS therapy', 'Ambulatory Counterpulsation Pump', 'NuPulseCV intravascular ventricular assist system (iVAS']","['functional capacity and quality of life', 'disabling neurological dysfunction', 'Six-minute walk distance, 2-minute step test, and Kansas City Cardiomyopathy Questionnaire score', 'Clinical Outcomes and Quality of Life', 'survival or transplant on iVAS therapy free from disabling stroke', 'intraoperative complications']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0010216', 'cui_str': 'Counterpulsation'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}]",47.0,0.180881,"Six-minute walk distance, 2-minute step test, and Kansas City Cardiomyopathy Questionnaire score improved during 4-week iVAS support.
","[{'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Uriel', 'Affiliation': 'Division of Cardiology, Columbia University Medical Center, New York, NY (N.U., G.S.).'}, {'ForeName': 'Valluvan', 'Initials': 'V', 'LastName': 'Jeevanandam', 'Affiliation': 'Department of Surgery, University of Chicago Medical Center, IL (V.J., T.I., D.O., T.S., T.O., C.J., P.C., T.L.).'}, {'ForeName': 'Teruhiko', 'Initials': 'T', 'LastName': 'Imamura', 'Affiliation': 'Department of Surgery, University of Chicago Medical Center, IL (V.J., T.I., D.O., T.S., T.O., C.J., P.C., T.L.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Onsager', 'Affiliation': 'Department of Surgery, University of Chicago Medical Center, IL (V.J., T.I., D.O., T.S., T.O., C.J., P.C., T.L.).'}, {'ForeName': 'Tae', 'Initials': 'T', 'LastName': 'Song', 'Affiliation': 'Department of Surgery, University of Chicago Medical Center, IL (V.J., T.I., D.O., T.S., T.O., C.J., P.C., T.L.).'}, {'ForeName': 'Takeyoshi', 'Initials': 'T', 'LastName': 'Ota', 'Affiliation': 'Department of Surgery, University of Chicago Medical Center, IL (V.J., T.I., D.O., T.S., T.O., C.J., P.C., T.L.).'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Juricek', 'Affiliation': 'Department of Surgery, University of Chicago Medical Center, IL (V.J., T.I., D.O., T.S., T.O., C.J., P.C., T.L.).'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Combs', 'Affiliation': 'Department of Surgery, University of Chicago Medical Center, IL (V.J., T.I., D.O., T.S., T.O., C.J., P.C., T.L.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lammy', 'Affiliation': 'Department of Surgery, University of Chicago Medical Center, IL (V.J., T.I., D.O., T.S., T.O., C.J., P.C., T.L.).'}, {'ForeName': 'Sonna', 'Initials': 'S', 'LastName': 'Patel-Raman', 'Affiliation': 'NuPulseCV, Raleigh, NC (S.P.-R., J.R.W.).'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Woolley', 'Affiliation': 'NuPulseCV, Raleigh, NC (S.P.-R., J.R.W.).'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Sayer', 'Affiliation': 'Division of Cardiology, Columbia University Medical Center, New York, NY (N.U., G.S.).'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Milano', 'Affiliation': 'Department of Cardiac Surgery, Duke University, Durham, NC (C.M., J.S.).'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Schroder', 'Affiliation': 'Department of Cardiac Surgery, Duke University, Durham, NC (C.M., J.S.).'}, {'ForeName': 'Ezequiel', 'Initials': 'E', 'LastName': 'Molina', 'Affiliation': 'Department of Surgery, MedStar Washington Hospital Center, DC. (E.M.).'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Grinstein', 'Affiliation': 'Department of Cardiology, MedStar Washington Hospital Center, DC. (J.G.).'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Suarez', 'Affiliation': 'Department of Cardiovascular Surgery, Houston Methodist Research Institute, Houston, TX (E.S.).'}, {'ForeName': 'Jerry D', 'Initials': 'JD', 'LastName': 'Estep', 'Affiliation': 'Kaufman Center for Heart Failure Treatment and Recovery, Cleveland Clinic Foundation, OH (J.D.E.).'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Aggarwal', 'Affiliation': ""Mid America Heart & Lung Surgeons, Saint Luke's Mid-America Heart Institute, Kansas City, MO (S.A.).""}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Silvestry', 'Affiliation': 'Department of Heart Failure and Transplant, AdventHealth Cardiovascular Institute, Orlando, FL (S.S., N.R.).'}, {'ForeName': 'Nirav', 'Initials': 'N', 'LastName': 'Raval', 'Affiliation': 'Department of Heart Failure and Transplant, AdventHealth Cardiovascular Institute, Orlando, FL (S.S., N.R.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.119.006666']
284,32265500,Dasatinib vs. imatinib in patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response to 3 months of imatinib therapy: the DASCERN randomized study.,"Early molecular response is associated with improved probability of deep molecular response and superior survival in patients with CML-CP. However, ~1 in 3 patients on first-line imatinib do not achieve this threshold. The phase 2b DASCERN trial (NCT01593254) assessed the outcome of early switch to dasatinib in patients with suboptimal response to first-line imatinib. Adult patients with CML-CP were randomized (2:1) to receive 100 mg dasatinib (n = 174) or continue imatinib at ≥400 mg (n = 86). The primary endpoint was the rate of major molecular response (MMR) at 12 months, which was 29% (dasatinib) and 13% (imatinib; P = 0.005). After ≥2 years of follow-up, 45 patients (52%) randomized to continue imatinib had crossed over to dasatinib. Considering treatment crossover, the 2-year cumulative MMR rate was 64% with dasatinib and 41% with imatinib (66% and 67%, respectively by intent-to-treat). Adverse events were consistent with the established safety profiles of both drugs. The results of this first prospective study support early monitoring of patients treated with first-line imatinib, and suggest that switching to dasatinib in cases of suboptimal response may offer clinical benefit. Further follow-up is needed to assess the long-term clinical benefit of early switching.",2020,"Considering treatment crossover, the 2-year cumulative MMR rate was 64% with dasatinib and 41% with imatinib (66% and 67%, respectively by intent-to-treat).","['patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response to 3 months of imatinib therapy', 'patients with CML-CP', 'Adult patients with CML-CP', 'patients with suboptimal response to first-line imatinib']","['Dasatinib vs. imatinib', '100\u2009mg dasatinib (n\u2009=\u2009174) or continue imatinib']","['probability of deep molecular response and superior survival', '2-year cumulative MMR rate', 'Adverse events', 'rate of major molecular response (MMR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023473', 'cui_str': 'Chronic myeloid leukemia'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C1455147', 'cui_str': 'dasatinib'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006416', 'cui_str': 'Burma'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.0336482,"Considering treatment crossover, the 2-year cumulative MMR rate was 64% with dasatinib and 41% with imatinib (66% and 67%, respectively by intent-to-treat).","[{'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': 'Georgia Cancer Center, Augusta University, Augusta, GA, USA. jorge.cortes@augusta.edu.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Jianxiang', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.'}, {'ForeName': 'Jianyu', 'Initials': 'J', 'LastName': 'Weng', 'Affiliation': ""Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.""}, {'ForeName': 'Huanling', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hochhaus', 'Affiliation': 'Universitätsklinikum Jena, Jena, Germany.'}, {'ForeName': 'Dong-Wook', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Jerald', 'Initials': 'J', 'LastName': 'Radich', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Savona', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Martin-Regueira', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Oumar', 'Initials': 'O', 'LastName': 'Sy', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Renuka', 'Initials': 'R', 'LastName': 'Gurnani', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Saglio', 'Affiliation': 'University of Turin, Turin, Italy.'}]",Leukemia,['10.1038/s41375-020-0805-1']
285,31454829,Acute kidney injury risk-based screening in pediatric inpatients: a pragmatic randomized trial.,"BACKGROUND


Pediatric acute kidney injury (AKI) is common and associated with increased morbidity, mortality, and length of stay. We performed a pragmatic randomized trial testing the hypothesis that AKI risk alerts increase AKI screening.
METHODS


All intensive care and ward admissions of children aged 28 days through 21 years without chronic kidney disease from 12/6/2016 to 11/1/2017 were included. The intervention alert displayed if calculated AKI risk was > 50% and no serum creatinine (SCr) was ordered within 24 h. The primary outcome was SCr testing within 48 h of AKI risk > 50%.
RESULTS


Among intensive care admissions, 973/1909 (51%) were randomized to the intervention. Among those at risk, more SCr tests were ordered for the intervention group than for controls (418/606, 69% vs. 361/597, 60%, p = 0.002). AKI incidence and severity were the same in intervention and control groups. Among ward admissions, 5492/10997 (50%) were randomized to the intervention, and there were no differences between groups in SCr testing, AKI incidence, or severity of AKI.
CONCLUSIONS


Alerts based on real-time prediction of AKI risk increased screening rates in intensive care but not pediatric ward settings. Pragmatic clinical trials provide the opportunity to assess clinical decision support and potentially eliminate ineffective alerts.",2020,AKI incidence and severity were the same in intervention and control groups.,"['pediatric inpatients', 'All intensive care and ward admissions of children aged 28 days through 21 years without chronic kidney disease from 12/6/2016 to 11/1/2017 were included']",[],"['serum creatinine (SCr', 'SCr tests', 'AKI incidence and severity', 'morbidity, mortality, and length of stay', 'SCr testing within 48\u2009h of AKI risk', 'SCr testing, AKI incidence, or severity of AKI', 'calculated AKI risk']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0085559'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",[],"[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.192399,AKI incidence and severity were the same in intervention and control groups.,"[{'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Van Driest', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA. sara.van.driest@vumc.org.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'McLemore', 'Affiliation': 'Health Information Technology, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Bridges', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Geoffrey M', 'Initials': 'GM', 'LastName': 'Fleming', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'McGregor', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Deborah P', 'Initials': 'DP', 'LastName': 'Jones', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Shirey-Rice', 'Affiliation': 'Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Gatto', 'Affiliation': 'Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Gay', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Byrne', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Asli', 'Initials': 'A', 'LastName': 'Weitkamp', 'Affiliation': 'Department of Biomedical Informatics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Roden', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Bernard', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}]",Pediatric research,['10.1038/s41390-019-0550-1']
286,32267624,Hysteropexy in the treatment of uterine prolapse stage 2 or higher: laparoscopic sacrohysteropexy versus sacrospinous hysteropexy-a multicentre randomised controlled trial (LAVA trial).,"OBJECTIVE


To investigate whether laparoscopic sacrohysteropexy (LSH) is non-inferior to vaginal sacrospinous hysteropexy (SSHP) in the surgical treatment of uterine prolapse.
DESIGN


Multicentre randomised controlled, non-blinded non-inferiority trial.
SETTING


Five non-university teaching hospitals in the Netherlands, one university hospital in Belgium.
POPULATION


126 women with uterine prolapse stage 2 or higher undergoing surgery without previous pelvic floor surgery.
METHODS


Randomisation in a 1:1 ratio to LSH or SSHP, stratified per centre and severity of the uterine prolapse. The predefined inferiority margin was an increase in surgical failure rate of 10%.
MAIN OUTCOME MEASURES


Primary outcome was surgical failure, defined as recurrence of uterine prolapse (POP-Q ≥ 2) with bothersome bulging/protrusion symptoms and/or repeat surgery or pessary at 12 months postoperatively. Secondary outcomes were anatomical recurrence (any compartment), functional outcome and quality of life.
RESULTS


Laparoscopic sacrohysteropexy was non-inferior for surgical failure (n = 1, 1.6%) compared with SSHP (n = 2, 3.3%, difference -1.7%, 95% CI: -7.1 to 3.7) 12 months postoperatively. Overall, anatomical recurrences and quality of life did not differ. More bothersome symptoms of overactive bladder (OAB) and faecal incontinence were reported after LSH. Dyspareunia was more frequently reported after SSHP.
CONCLUSION


Laparoscopic sacrohysteropexy was non-inferior to SSHP for surgical failure of the apical compartment at 12 months' follow up. Following LSH, bothersome OAB and faecal incontinence were more frequent, but dyspareunia was less frequent.
TWEETABLE ABSTRACT


Laparoscopic sacrohysteropexy and vaginal sacrospinous hysteropexy have equally good short-term outcomes.",2020,"CONCLUSION


LSH was non-inferior to SSHP for surgical failure of the apical compartment at 12 months' follow-up.","['uterine prolapse stage 2 or higher', 'Randomisation in a 1:1 ratio to LSH or SSHP, stratified per centre and severity of the uterine prolapse', '5 non-university teaching hospitals in the Netherlands, one university hospital in Belgium', '126 women with uterine prolapse stage 2 or higher undergoing surgery without previous pelvic floor surgery']","['LSH', 'Hysteropexy', 'laparoscopic sacrohysteropexy versus sacrospinous hysteropexy', 'laparoscopic sacrohysteropexy (LSH']","['surgical failure', 'dyspareunia', 'Overall anatomical recurrences and quality of life', 'anatomical recurrence (any compartment), functional outcome and quality of life', 'Dyspareunia', 'bothersome symptoms of overactive bladder (OAB) and faecal incontinence', 'bothersome OAB and faecal incontinence', 'surgical failure rate', 'surgical failure, defined as reoccurrence of uterine prolapse (POP-Q ≥ 2) with bothersome bulging/protrusion symptoms and/or repeat surgery or pessary at 12 months postoperative']","[{'cui': 'C0042140', 'cui_str': 'Uterine prolapse'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}]","[{'cui': 'C0195386', 'cui_str': 'Uteropexy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C3164185', 'cui_str': 'Sacrohysteropexy'}]","[{'cui': 'C1868733', 'cui_str': 'Surgical failure'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0042140', 'cui_str': 'Uterine prolapse'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",126.0,0.455185,"CONCLUSION


LSH was non-inferior to SSHP for surgical failure of the apical compartment at 12 months' follow-up.","[{'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'van IJsselmuiden', 'Affiliation': 'Department of Obstetrics and Gynaecology, Isala, Zwolle, The Netherlands.'}, {'ForeName': 'Amj', 'Initials': 'A', 'LastName': 'van Oudheusden', 'Affiliation': 'Department of Obstetrics and Gynaecology, GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Veen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, The Netherlands.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'van de Pol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Gelre Ziekenhuizen, Apeldoorn, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vollebregt', 'Affiliation': 'Department of Obstetrics and Gynaecology, Spaarne Gasthuis, Hoofddorp, The Netherlands.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Radder', 'Affiliation': 'Department of Obstetrics and Gynaecology, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Housmans', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Smj', 'Initials': 'S', 'LastName': 'van Kuijk', 'Affiliation': 'Department of Obstetrics and Gynaecology, GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Deprest', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'M Y', 'Initials': 'MY', 'LastName': 'Bongers', 'Affiliation': 'Department of Obstetrics and Gynaecology, GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Hwf', 'Initials': 'H', 'LastName': 'van Eijndhoven', 'Affiliation': 'Department of Obstetrics and Gynaecology, Isala, Zwolle, The Netherlands.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16242']
287,30921105,The Legacy for Children™ Randomized Control Trial: Effects on Cognition Through Third Grade for Young Children Experiencing Poverty.,"OBJECTIVE


In an effort to promote the health and developmental outcomes of children born into poverty, the Centers for Disease Control and Prevention (CDC) conceptualized and designed the Legacy for Children™ (Legacy) public health prevention model. This article examines the impact of Legacy on children's cognitive and language development (intelligence quotient [IQ], achievement, language skills, and early reading skills) using both standardized assessments and parent-reported indictors through third grade.
METHODS


Data were collected from 2001 to 2014 from 541 mother-child dyads who were recruited into the 2 concurrent randomized controlled trials of Legacy in Miami and Los Angels. Cognitive and/or language outcomes of children were assessed annually from age 2 to 5 years as well as during a follow-up visit in the third grade.
RESULTS


Children experiencing Legacy at the Los Angeles site had significantly higher IQ and achievement scores at 2 and 6 years postintervention, equivalent to approximately one-third of an SD (4 IQ points). IQ results persisted over time, and the difference between intervention and comparison groups on achievement scores widened. There were no significant differences in cognitive outcomes in the Miami sample. There were no significant differences in language outcomes for either site.
CONCLUSION


Legacy shows evidence of effectiveness as an intervention to prevent cognitive delays among children living in poverty. The mixed findings across sites may not only reflect the impact of heterogeneous risk profiles noted by other intervention research programs but also warrant additional study.",2019,"RESULTS


Children experiencing Legacy at the Los Angeles site had significantly higher IQ and achievement scores at 2 and 6 years postintervention, equivalent to approximately one-third of an SD (4 IQ points).","['children born into poverty, the Centers for Disease Control and Prevention (CDC) conceptualized and designed the Legacy for Children™ (Legacy) public health prevention model', 'Data were collected from 2001 to 2014 from 541 mother-child dyads who were recruited into the 2 concurrent randomized controlled trials of Legacy in Miami and Los Angels', 'children were assessed annually from age 2 to 5 years as well as during a follow-up visit in the third grade', 'Young Children Experiencing Poverty', 'children living in poverty']",[],"['language outcomes', 'cognitive outcomes', 'Cognitive and/or language outcomes', 'IQ and achievement scores', ""children's cognitive and language development (intelligence quotient [IQ], achievement, language skills, and early reading skills""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0032854', 'cui_str': 'Poverty'}, {'cui': 'C0007670', 'cui_str': 'CDC'}, {'cui': 'C2979241', 'cui_str': 'Legacy'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]",[],"[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023013', 'cui_str': 'Language Development'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient (observable entity)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]",,0.0628776,"RESULTS


Children experiencing Legacy at the Los Angeles site had significantly higher IQ and achievement scores at 2 and 6 years postintervention, equivalent to approximately one-third of an SD (4 IQ points).","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Perou', 'Affiliation': 'National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, GA.'}, {'ForeName': 'Lara R', 'Initials': 'LR', 'LastName': 'Robinson', 'Affiliation': 'National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, GA.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Danielson', 'Affiliation': 'National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, GA.'}, {'ForeName': 'Angelika H', 'Initials': 'AH', 'LastName': 'Claussen', 'Affiliation': 'National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, GA.'}, {'ForeName': 'Susanna N', 'Initials': 'SN', 'LastName': 'Visser', 'Affiliation': 'National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention, Fort Collins, CO.'}, {'ForeName': 'Keith G', 'Initials': 'KG', 'LastName': 'Scott', 'Affiliation': 'Linda Ray Intervention Center, University of Miami, Miami, FL.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Beckwith', 'Affiliation': 'Department of Pediatrics, University of California at Los Angeles, Los Angeles, CA.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Katz', 'Affiliation': 'Linda Ray Intervention Center, University of Miami, Miami, FL.'}, {'ForeName': 'D Camille', 'Initials': 'DC', 'LastName': 'Smith', 'Affiliation': 'National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, GA.'}]",Journal of developmental and behavioral pediatrics : JDBP,['10.1097/DBP.0000000000000656']
288,31910992,Long-Term Neurobehavioral and Quality of Life Outcomes of Critically Ill Children after Glycemic Control.,"OBJECTIVES


To investigate adaptive skills, behavior, and quality health-related quality of life in children from 32 centers enrolling in the Heart And Lung Failure-Pediatric INsulin Titration randomized controlled trial.
STUDY DESIGN


This prospective longitudinal cohort study compared the effect of 2 tight glycemic control ranges (lower target, 80-100 mg/dL vs higher target, 150-180 mg/dL) 1-year neurobehavioral and health-related quality of life outcomes. Subjects had confirmed hyperglycemia and cardiac and/or respiratory failure. Patients aged 2-16 years old enrolled between April 2012 and September 2016 were studied at 1 year after intensive care discharge. The primary outcome, adaptive skills, was assessed using the Vineland Adaptive Behavior Scale. Behavior and health-related quality of life outcomes were assessed as secondary outcomes using the Pediatric Quality of Life and Child Behavior Checklist at baseline and 1-year follow-up. Group differences were evaluated using regression models adjusting for age category, baseline overall performance, and risk of mortality.
RESULTS


Of 369 eligible children, 358 survived after hospital discharge and 214 (60%) completed follow-up. One-year Vineland Adaptive Behavior Scale-II composite scores were not different (mean ± SD, 79.9 ± 25.5 vs 79.4 ± 26.9, lower vs higher target; P = .20). Improvement in Pediatric Quality of Life total health from baseline was greater in the higher target group (adjusted mean difference, 8.2; 95% CI, 1.1-15.3; P = .02).
CONCLUSIONS


One-year adaptive behavior in critically ill children with lower vs higher target glycemic control did not differ. The higher target group demonstrated improvement from baseline in overall health. This study affirms the lack of benefit of lower glucose targeting.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT01565941.",2020,"One-year Vineland Adaptive Behavior Scale-II composite scores were not different (mean ± SD, 79.9 ± ","['Subjects had confirmed hyperglycemia and cardiac and/or respiratory failure', 'Patients aged 2-16\xa0years old enrolled between April 2012 and September 2016 were studied at 1\xa0year after intensive care discharge', '369 eligible children, 358 survived after hospital discharge and 214 (60%) completed follow-up', 'children from 32 centers enrolling in the Heart And Lung Failure-Pediatric INsulin Titration randomized controlled trial', 'Critically Ill Children after Glycemic Control']",[],"['neurobehavioral and health-related quality of life outcomes', 'Behavior and health-related quality of life outcomes', 'adaptive skills', 'Vineland Adaptive Behavior Scale', 'adaptive skills, behavior, and quality health-related quality of life', 'overall performance, and risk of mortality', 'Pediatric Quality of Life and Child Behavior Checklist', 'One-year Vineland Adaptive Behavior Scale-II composite scores', 'Pediatric Quality of Life total health', 'overall health']","[{'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C3889105', 'cui_str': 'Respiratory failure (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0085559'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0582680', 'cui_str': 'Vineland adaptive behavior scales (assessment scale)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",369.0,0.429229,"One-year Vineland Adaptive Behavior Scale-II composite scores were not different (mean ± SD, 79.9 ± ","[{'ForeName': 'Katherine V', 'Initials': 'KV', 'LastName': 'Biagas', 'Affiliation': ""Department of Pediatrics, Stony Brook Children's Hospital and the Renaissance School of Medicine, Stony Brook, NY. Electronic address: katherine.biagas@stonybrookmedicine.edu.""}, {'ForeName': 'Veronica J', 'Initials': 'VJ', 'LastName': 'Hinton', 'Affiliation': 'Department of Psychology, Queens College and the Graduate Center of the City University of New York, New York, NY.'}, {'ForeName': 'Natalie R', 'Initials': 'NR', 'LastName': 'Hasbani', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Luckett', 'Affiliation': ""Department of Pediatrics, University of Texas Southwestern Medical Center and Children's Health, Dallas, TX.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wypij', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Vinay M', 'Initials': 'VM', 'LastName': 'Nadkarni', 'Affiliation': ""Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia and the University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Michael S D', 'Initials': 'MSD', 'LastName': 'Agus', 'Affiliation': ""Division of Medical Critical Care, Department of Pediatrics, Boston Children's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.10.055']
289,32265129,A Randomized Phase II Trial of Prostate Boost Irradiation With Stereotactic Body Radiotherapy (SBRT) or Conventional Fractionation (CF) External Beam Radiotherapy (EBRT) in Locally Advanced Prostate Cancer: The PBS Trial (NCT03380806).,"Standard therapy for high-risk (HR) prostate cancer (PrCa) involves androgen deprivation therapy (ADT) and pelvic conventional fractionation (CF) external beam radiotherapy (EBRT) followed by boost CF-EBRT treatment to prostate for a total of 78 to 80 Gy in 39 to 40 fractions. This is a long and inconvenient treatment for patients. Brachytherapy boost treatment studies indicate that escalation of biological dose of radiotherapy (RT) can improve outcomes in HR-PrCa. However, brachytherapy is an invasive treatment associated with increased toxicity and requires specialized resources. Stereotactic body radiotherapy (SBRT) is a promising, non-invasive alternative to brachytherapy. However, its impact on patient quality of life (QoL) and RT-associated toxicity has not been investigated in a randomized setting. In this study, we investigate SBRT as a boost treatment, following pelvic CF-EBRT, in patients with HR-PrCa treated with ADT. One hundred patients with locally advanced PrCa will be randomized to receive daily CF-EBRT of 45 to 46 Gy in 23 to 25 fractions followed by either daily CF-EBRT of 32 to 33 Gy in 15 to 16 fractions (control arm) or SBRT boost treatment of 19.5 to 21 Gy in 3 fractions (1 fraction per week) (experimental arm). The primary objective of the PBS trial is early bowel and urinary QoL (expanded prostate index composite [EPIC], up to 6 months after RT). This phase II randomized study (PBS) provides an appropriate setting to investigate effectively the impact of SBRT boost on QoL and toxicity in patients with HR-PrCa, before this modality can be compared against the current standard of care in larger phase III protocols.",2020,Brachytherapy boost treatment studies indicate that escalation of biological dose of radiotherapy (RT) can improve outcomes in HR-PrCa.,"['patients with HR-PrCa', 'patients with HR-PrCa treated with ADT', 'patients', 'One hundred patients with locally advanced PrCa', 'Locally Advanced Prostate Cancer']","['brachytherapy', 'SBRT boost', 'radiotherapy (RT', 'daily CF-EBRT', 'SBRT', 'Stereotactic Body Radiotherapy (SBRT) or Conventional Fractionation (CF', 'Prostate Boost Irradiation', 'External Beam Radiotherapy (EBRT', 'androgen deprivation therapy (ADT) and pelvic conventional fractionation (CF) external beam radiotherapy (EBRT', 'Stereotactic body radiotherapy (SBRT']","['early bowel and urinary QoL (expanded prostate index composite [EPIC', 'toxicity', 'patient quality of life (QoL) and RT-associated toxicity', 'QoL and toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034902', 'cui_str': 'Pure red cell aplasia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0006098', 'cui_str': 'Brachytherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0524811', 'cui_str': 'Dose Fractionation, Radiotherapy'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",100.0,0.047573,Brachytherapy boost treatment studies indicate that escalation of biological dose of radiotherapy (RT) can improve outcomes in HR-PrCa.,"[{'ForeName': 'Naghmeh', 'Initials': 'N', 'LastName': 'Isfahanian', 'Affiliation': 'Radiation Oncology, Department of Oncology, Juravinski Cancer Center, McMaster University, Hamilton, ON, Canada; Department of Oncology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Lukka', 'Affiliation': 'Radiation Oncology, Department of Oncology, Juravinski Cancer Center, McMaster University, Hamilton, ON, Canada; Department of Oncology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Dayes', 'Affiliation': 'Radiation Oncology, Department of Oncology, Juravinski Cancer Center, McMaster University, Hamilton, ON, Canada; Department of Oncology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Kimmen', 'Initials': 'K', 'LastName': 'Quan', 'Affiliation': 'Radiation Oncology, Department of Oncology, Juravinski Cancer Center, McMaster University, Hamilton, ON, Canada; Department of Oncology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Kara Lynne', 'Initials': 'KL', 'LastName': 'Schnarr', 'Affiliation': 'Radiation Oncology, Department of Oncology, Juravinski Cancer Center, McMaster University, Hamilton, ON, Canada; Department of Oncology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Douvi', 'Affiliation': 'Department of Oncology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Goldberg', 'Affiliation': 'Radiation Oncology, Department of Oncology, Juravinski Cancer Center, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Wright', 'Affiliation': 'Radiation Oncology, Department of Oncology, Juravinski Cancer Center, McMaster University, Hamilton, ON, Canada; Department of Oncology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Swaminath', 'Affiliation': 'Radiation Oncology, Department of Oncology, Juravinski Cancer Center, McMaster University, Hamilton, ON, Canada; Department of Oncology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Chow', 'Affiliation': 'Medical Physics, Department of Oncology, Juravinski Cancer Center, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Diamond', 'Affiliation': 'Medical Physics, Department of Oncology, Juravinski Cancer Center, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jean Claude', 'Initials': 'JC', 'LastName': 'Cutz', 'Affiliation': 'Departments of Oncology, Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kavsak', 'Affiliation': 'Departments of Oncology, Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': ""Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Biostatistics Unit, St Joseph's Healthcare, Hamilton, ON, Canada.""}, {'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Tsakiridis', 'Affiliation': 'Radiation Oncology, Department of Oncology, Juravinski Cancer Center, McMaster University, Hamilton, ON, Canada; Department of Oncology, McMaster University, Hamilton, ON, Canada; Departments of Oncology, Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada. Electronic address: theos.tsakiridis@hhsc.ca.'}]",Clinical genitourinary cancer,['10.1016/j.clgc.2019.12.020']
290,31953540,Very Low and Higher Carbohydrate Diets Promote Differential Appetite Responses in Adults with Type 2 Diabetes: A Randomized Trial.,"BACKGROUND


Effects of very low carbohydrate (VLC) diets on appetite response in individuals with type 2 diabetes remain unclear.
OBJECTIVE


A secondary analysis was conducted to determine appetite responses to an energy-restricted [30% of energy (%E) deficit] very low carbohydrate (VLC) diet compared with a higher carbohydrate (HC) diet in adults who were overweight or obese with type 2 diabetes.
METHODS


Forty-four men and 40 women (mean ± SD, age: 58.7 ± 6.6 y; weight: 100.4 ± 15.5 kg; BMI: 34.5 ± 4.1 kg/m2; glycated hemoglobin: 7.3 ± 1.0%; duration of diabetes: 6.7 ± 5.6 y) were randomly assigned to diets categorized as VLC [14%E carbohydrate (<50 g/d), 28%E protein, 58%E fat (<10%E saturated fat)], or energy-matched HC [53%E carbohydrate, 17%E protein, 30%E fat (<10%E saturated fat)] combined with progressive multicomponent exercise (60 min; 3 d/wk). Body weight, average weekly ""daily fasting"" and ""daily overall"" appetite perceptions (hunger, fullness, prospective consumption, and desire to eat-visual analog scales) were assessed at baseline and after 4 and 16 wk. Changes between diets over time were assessed using repeated measures ANOVA.
RESULTS


Significant decreases in body weight did not differ between groups (VLC: -11.0 ± 5.4 kg/16 wk compared with HC: -10.1 ± 4.3 kg/16 wk, P = 0.40). Compared with HC, VLC had greater decreases in ""daily overall"" ratings of fullness (P time × diet < 0.01), such that scores were higher in HC at Week 4 (VLC:48 ± 3 vs HC:56 ± 3 mm, P = 0.001) and 16 (VLC:51 ± 2 vs HC:57 ± 3 mm, P = 0.019). Compared with HC, VLC had greater increases in prospective consumption ratings (P time × diet = 0.03), such that scores were lower in HC at Week 4 (VLC:33 ± 2 vs HC:28 ± 2 mm, P = 0.008), but not at Week 16 (VLC:33 ± 2 vs HC 31 ± 2 mm, P = 0.289).
CONCLUSIONS


In the context of energy restriction, both HC and VLC energy-matched diets promoted comparable effects on fasting perceptions of appetite, but the HC diet resulted in greater ""daily overall"" fullness and reduced prospective consumption. Further research is required to evaluate the effects of ad libitum diets differing in amounts of carbohydrate on appetite response in populations with type 2 diabetes. This trial was registered at www.anzctr.org.au as ACTRN12612000369820.",2020,"There was no difference between diet groups in ""daily fasting"" appetite ratings (P ≥ 0.30) or ""daily overall"" hunger and desire to eat (P ","['Forty-four men and 40 women (mean\xa0±\xa0SD, age: 58.7\xa0±', 'individuals with type 2 diabetes remain unclear', 'Adults with Type 2 Diabetes', 'populations with type 2 diabetes', '6.6 y; weight: 100.4\xa0±\xa015.5\xa0kg; BMI: 34.5\xa0±\xa04.1\xa0kg/m2; glycated hemoglobin: 7.3\xa0±\xa01.0%; duration of diabetes: 6.7\xa0±\xa05.6 y', 'adults who were overweight or obese with type 2 diabetes']","['low carbohydrate (VLC) diets', 'low carbohydrate (VLC) diet compared with a higher carbohydrate (HC) diet', 'HC', 'HC, VLC', 'Carbohydrate Diets', 'diets categorized as VLC [14%E carbohydrate (<50\xa0g/d), 28%E protein, 58%E fat (<10%E saturated fat)], or energy-matched HC [53%E carbohydrate, 17%E protein, 30%E fat (<10%E saturated fat)] combined with progressive multicomponent exercise']","['daily overall"" ratings of fullness', 'Body weight, average weekly ""daily fasting"" and ""daily overall"" appetite perceptions (hunger, fullness, prospective consumption, and desire to eat-visual analog scales', 'body weight', 'daily overall"" hunger and desire to eat (P', 'appetite response', 'daily fasting"" appetite ratings', 'daily overall"" fullness', 'prospective consumption ratings', 'appetite responses']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517823', 'cui_str': '6.6 (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}, {'cui': 'C0259835', 'cui_str': 'High carbohydrate diet (finding)'}, {'cui': 'C0301577', 'cui_str': 'Carbohydrate diet (finding)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]",44.0,0.0441091,"There was no difference between diet groups in ""daily fasting"" appetite ratings (P ≥ 0.30) or ""daily overall"" hunger and desire to eat (P ","[{'ForeName': 'Noor A', 'Initials': 'NA', 'LastName': 'Struik', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation - Health and Biosecurity, North Ryde, Australia.'}, {'ForeName': 'Grant D', 'Initials': 'GD', 'LastName': 'Brinkworth', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation - Health and Biosecurity, North Ryde, Australia.'}, {'ForeName': 'Campbell H', 'Initials': 'CH', 'LastName': 'Thompson', 'Affiliation': 'Discipline of Medicine, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Buckley', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity (ARENA), Sansom Institute for Health Research, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Wittert', 'Affiliation': 'Discipline of Medicine, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Natalie D', 'Initials': 'ND', 'LastName': 'Luscombe-Marsh', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation - Health and Biosecurity, Adelaide, Australia.'}]",The Journal of nutrition,['10.1093/jn/nxz344']
291,32250730,Sporadic Angiomyolipomas Growth Kinetics While on Everolimus: Results of a Phase II Trial.,"PURPOSE


Everolimus decreases tumor volume of renal angiomyolipomas in patients with tuberous sclerosis. No prospective data are available regarding the effect of everolimus on the growth kinetics in patients with sporadic angiomyolipomas. We sought to determine the safety and efficacy of everolimus in the volumetric reduction of sporadic angiomyolipomas.
MATERIALS AND METHODS


This multi-institutional, prospective, phase II trial, enrolled patients with 3 cm or larger sporadic angiomyolipomas who were candidates for surgical resection or percutaneous angioembolization. Patients received 10 mg everolimus daily for 4 planned 28-day cycles. Response was defined as a 25% or greater volumetric reduction of patient angiomyolipoma. Baseline, 4, 6 and 12-month volumetric analyses were performed using magnetic resonance imaging. Everolimus was discontinued in those with less than 25% volumetric reduction after 4 cycles. Those with 25% or greater volumetric reduction received 2 additional cycles. The primary outcomes were the efficacy of everolimus in the volumetric reduction of angiomyolipomas by 25% or more, and the safety and tolerability of everolimus.
RESULTS


Overall 20 patients were enrolled at 5 centers. Of these patients 11 (55%) completed 4 cycles and 7 (35%) completed 6 cycles. Efficacy was demonstrated, with 10 of 18 (55.6%) patients exhibiting a 25% or greater reduction in tumor volume at 4 months (median 58.5%) and 10 of 14 (71.4%) patients exhibiting a 25% or greater reduction in tumor volume at 6 months (median 58.2%). Four (20%) patients were withdrawn due to protocol defined toxicities and 8 (40%) self-withdrew from the study due to side effects.
CONCLUSIONS


Everolimus was effective in causing volumetric reduction of angiomyolipomas by 25% or greater in most patients but was associated with a high rate of treatment discontinuation.",2020,"The primary outcomes were the efficacy of everolimus in the volumetric reduction of angiomyolipomas by ≥25% and the safety and tolerability of everolimus.
","['Sporadic Angiomyolipomas (AMLs', 'patients with sporadic angiomyolipomas', '20 patients were enrolled at 5 centers', 'patients with tuberous sclerosis', 'enrolled patients with ≥3cm sporadic angiomyolipomas who were candidates for surgical resection or percutaneous angioembolization']","['Everolimus (SAGE', 'everolimus', 'Everolimus']","['safety and tolerability of everolimus', 'efficacy of everolimus in the volumetric reduction of angiomyolipomas', 'safety and efficacy', 'tumor volume', 'toxicities', 'volumetric reduction of angiomyolipomas', 'Efficacy', 'Growth Kinetics', 'renal angiomyolipomas']","[{'cui': 'C0205422', 'cui_str': 'Sporadic'}, {'cui': 'C0206633', 'cui_str': 'Angiomyolipoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041341', 'cui_str': 'Tuberous sclerosis syndrome'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C1122976', 'cui_str': 'Sage'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0206633', 'cui_str': 'Angiomyolipoma'}, {'cui': 'C0475276', 'cui_str': 'Tumor volume'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]",20.0,0.03125,"The primary outcomes were the efficacy of everolimus in the volumetric reduction of angiomyolipomas by ≥25% and the safety and tolerability of everolimus.
","[{'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Geynisman', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Kadow', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Shuch', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Boorjian', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Surena F', 'Initials': 'SF', 'LastName': 'Matin', 'Affiliation': 'MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Rampersaud', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Barton N', 'Initials': 'BN', 'LastName': 'Milestone', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Plimack', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Zibelman', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kutikov', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Marc C', 'Initials': 'MC', 'LastName': 'Smaldone', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'David Yt', 'Initials': 'DY', 'LastName': 'Chen', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Rosalia', 'Initials': 'R', 'LastName': 'Viterbo', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Shreyas', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Greenberg', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Malizzia', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'McGowan', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Ross', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Uzzo', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}]",The Journal of urology,['10.1097/JU.0000000000001065']
292,31273507,Relationship between circadian activity rhythms and fatigue in hospitalized children with CNS cancers receiving high-dose chemotherapy.,"PURPOSE


Robust circadian rhythms are increasingly recognized as essential to good health. Adult cancer patients with dysregulated circadian activity rhythms (CAR) experience greater fatigue, lower responsiveness to chemotherapy, and shorter time to relapse. There is scant research describing circadian rhythms and associated outcomes in children with cancer. As part of a larger study examining whether a cognitive-behavioral intervention could preserve sleep in children and adolescents with central nervous system cancers hospitalized for high-dose chemotherapy (HDCT), this study aimed to compare CAR of these children to published values and to investigate the relationship between CAR and fatigue.
METHODS


Participants aged 4-19 years wore an actigraph throughout their hospitalization (5 days). From activity counts recorded by actigraphy, six CAR variables were calculated: amplitude, 24-h autocorrelation (r24), dichotomy index (I < O), interdaily stability (IS), intradaily variability (IV), and acrophase. Parent-reported child fatigue and child/adolescent self-reported fatigue measures were collected daily.
RESULTS


Thirty-three participants were included. Three CAR variables (amplitude, r24, and I < O) showed dysregulation compared to published values. Older age was significantly associated with later acrophase and greater dysregulation of all other CAR variables. Controlling for age, more dysregulated amplitude (p = 0.001), r24 (p = 0.003), IS (p = 0.017), and IV (p = 0.001) were associated with higher parent-reported fatigue; more dysregulated IV (p = 0.003) was associated with higher child-reported fatigue.
CONCLUSIONS


Participants demonstrated dysregulated CAR during hospitalization for HDCT. Greater dysregulation was associated with greater fatigue. Research on circadian dysregulation and its relationship to health-related outcomes in children with cancer, and interventions to support circadian rhythmicity, is urgently needed.",2020,"Controlling for age, more dysregulated amplitude (p = 0.001), r24 (p = 0.003), IS (p = 0.017), and IV (p = 0.001) were associated with higher parent-reported fatigue; more dysregulated IV (p = 0.003) was associated with higher child-reported fatigue.
","['Participants aged 4-19\xa0years wore an actigraph throughout their hospitalization (5\xa0days', 'hospitalized children with CNS cancers receiving high-dose chemotherapy', 'Thirty-three participants were included', 'children and adolescents with central nervous system cancers hospitalized for high-dose chemotherapy (HDCT', 'Adult cancer patients with dysregulated circadian activity rhythms (CAR', 'children with cancer']",['cognitive-behavioral intervention'],"['fatigue', 'child fatigue and child/adolescent self-reported fatigue measures', 'amplitude, 24-h autocorrelation (r24), dichotomy index (I < O), interdaily stability (IS), intradaily variability (IV), and acrophase']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C0085136', 'cui_str': 'Neoplasm of central nervous system'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0348374', 'cui_str': 'Malignant neoplasm of central nervous system'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",33.0,0.04269,"Controlling for age, more dysregulated amplitude (p = 0.001), r24 (p = 0.003), IS (p = 0.017), and IV (p = 0.001) were associated with higher parent-reported fatigue; more dysregulated IV (p = 0.003) was associated with higher child-reported fatigue.
","[{'ForeName': 'Valerie E', 'Initials': 'VE', 'LastName': 'Rogers', 'Affiliation': 'University of Maryland, 655 W. Lombard Street, Baltimore, MD, 21201, USA. verogers@umaryland.edu.'}, {'ForeName': 'Shijun', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'University of Maryland, 655 W. Lombard Street, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Belinda N', 'Initials': 'BN', 'LastName': 'Mandrell', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Ancoli-Israel', 'Affiliation': 'University of California, San Diego, CA, USA.'}, {'ForeName': 'Lianqi', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'University of California, San Diego, CA, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Hinds', 'Affiliation': ""Nursing, Children's National Health System and George Washington University, Washington, DC, USA.""}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-04960-5']
293,32251039,NursE led Atrial Fibrillation Management: The NEAT Study: A Randomized Controlled Trial.,"BACKGROUND


Atrial fibrillation (AF) is a growing epidemic. Current models of care delivery are inadequate in meeting the needs of the population with AF. Furthermore, quality of life is known to be poor in patients with AF and is associated with adverse patient outcomes.
OBJECTIVE


The aim of this study was to determine if nurse-led education and cardiovascular risk factor modification, undertaken using the principles of motivational interviewing, facilitated by an electronic decision support tool to ensure the appropriate use of oral anticoagulation (OAC), could improve health-related quality of life (HRQoL), guideline adherence to OAC, and cardiovascular risk factor profiles in individuals with AF.
METHODS


This was a multicenter, prospective, randomized controlled feasibility study of 72 individuals with AF. The intervention involved 1 face-to-face nurse-delivered education and risk factor management session with 4 follow-up telephone calls over a 3-month period to monitor progress. The primary outcome measure was HRQoL as assessed by the Short Form-12 survey.
RESULTS


A total of 72 participants were randomized, with 36 individuals in each arm completing follow-up. Mean age was 65 ± 11 years and 44% were women. At 3 months follow-up, no significant differences between groups were observed for the physical or mental component summary scores of the Short Form-12, nor any of the subscales. Appropriate use of OAC did not differ between groups at final follow-up.
CONCLUSIONS


A brief nurse-delivered educational intervention did not significantly impact on HRQoL or risk factor status in individuals with AF. Further research should focus on interventions of greater intensity to improve outcomes in this population.
TRIAL REGISTRATION


ACTRN12615000928516.",2020,"At 3 months follow-up, no significant differences between groups were observed for the physical or mental component summary scores of the Short Form-12, nor any of the subscales.","['individuals with AF.\nMETHODS', '72 participants were randomized, with 36 individuals in each arm completing follow-up', '72 individuals with AF', 'Mean age was 65 ± 11 years and 44% were women', 'individuals with AF']","['educational intervention', 'intervention involved 1 face-to-face nurse-delivered education and risk factor management session with 4 follow-up telephone calls']","['HRQoL', 'quality of life', 'physical or mental component summary scores', 'HRQoL or risk factor status', 'health-related quality of life (HRQoL), guideline adherence to OAC, and cardiovascular risk factor profiles']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0525059', 'cui_str': 'Guideline Adherence'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",72.0,0.133146,"At 3 months follow-up, no significant differences between groups were observed for the physical or mental component summary scores of the Short Form-12, nor any of the subscales.","[{'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Gallagher', 'Affiliation': 'Celine Gallagher, RN, PhD Nurse, Centre for Heart Rhythm Disorders, University of Adelaide and Royal Adelaide Hospital, Adelaide, Australia. Jessica Orchard, MPH Lecturer, Heart Research Institute, Charles Perkins Centre, The University of Sydney, Sydney, Australia. Karin Nyfort-Hansen, B Pharm, Grad Dip Ed(Health) Pharmacist, Centre for Heart Rhythm Disorders, University of Adelaide and Royal Adelaide Hospital, Adelaide, Australia. Prashanthan Sanders, MBBS, PhD Professor of Cardiology, Centre for Heart Rhythm Disorders, University of Adelaide and Royal Adelaide Hospital, Adelaide, Australia. Lis Neubeck, RN, PhD Professor of Nursing, Heart Research Institute, Charles Perkins Centre, The University of Sydney, Sydney, Australia, and School of Health and Social Care, Edinburgh Napier University. Jeroen M. Hendriks, RN, PhD Professor of Cardiovascular Nursing, College of Nursing and Health Sciences, Flinders University; Department of Cardiology, Royal Adelaide Hospital; Centre for Heart Rhythm Disorders, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Orchard', 'Affiliation': ''}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Nyfort-Hansen', 'Affiliation': ''}, {'ForeName': 'Prashanthan', 'Initials': 'P', 'LastName': 'Sanders', 'Affiliation': ''}, {'ForeName': 'Lis', 'Initials': 'L', 'LastName': 'Neubeck', 'Affiliation': ''}, {'ForeName': 'Jeroen M', 'Initials': 'JM', 'LastName': 'Hendriks', 'Affiliation': ''}]",The Journal of cardiovascular nursing,['10.1097/JCN.0000000000000680']
294,31926063,Efficacy of the Digital Therapeutic Mobile App BioBase to Reduce Stress and Improve Mental Well-Being Among University Students: Randomized Controlled Trial.,"BACKGROUND


University students in the United Kingdom are experiencing increasing levels of anxiety. A program designed to increase awareness of one's present levels of well-being and suggest personalized health behaviors may reduce anxiety and improve mental well-being in students. The efficacy of a digital version of such a program, providing biofeedback and therapeutic content based on personalized well-being metrics, is reported here.
OBJECTIVE


The aim of this study was to test the efficacy and sustained effects of using a mobile app (BioBase) and paired wearable device (BioBeam), compared with a waitlist control group, on anxiety and well-being in university students with elevated levels of anxiety and stress.
METHODS


The study employed a randomized, waitlist-controlled trial with assessments at baseline, 2 weeks, postintervention (4 weeks), and follow-up (6 weeks). Participants were eligible if they were current full-time undergraduate students and (1) at least 18 years of age, (2) scored >14 points on the Depression, Anxiety, and Stress Scale-21 items (DASS-21) stress subscale or >7 points on the DASS-21 anxiety subscale, (3) owned an iOS mobile phone, (4) did not have any previous psychiatric or neurological conditions, (6) were not pregnant at the time of testing, and (7) were able to read and understand English. Participants were encouraged to use BioBase daily and complete at least one course of therapeutic content. A P value ≤.05 was considered statistically significant.
RESULTS


We found that a 4-week intervention with the BioBase program significantly reduced anxiety and increased perceived well-being, with sustained effects at a 2-week follow-up. Furthermore, a significant reduction in depression levels was found following the 4-week usage of BioBase.
CONCLUSIONS


This study shows the efficacy of a biofeedback digital intervention in reducing self-reported anxiety and increasing perceived well-being in UK university students. Results suggest that digital mental health interventions could constitute a novel approach to treat stress and anxiety in students, which could be combined or integrated with existing therapeutic pathways.
TRIAL REGISTRATION


Open Science Framework (OSF.io) 2zd45; https://osf.io/2zd45/.",2020,"We found that a 4-weeks intervention with the BioBase programme significantly reduced anxiety and increased perceived wellbeing, with sustained effects at a 2-weeks follow-up.","['university students with elevated levels of anxiety and stress', 'UK university students', 'Participants were eligible if they were current full-time undergraduate students and (1) at least 18 years of age, (2) scored >14 points on the DASS-21 stress subscale or > 7 points on the DASS-21 anxiety subscale, (3) owned an iOS smartphone, (4) did not have any previous psychiatric or neurological conditions, (6) were not pregnant at the time of testing, and (7) were able to read and understand English', 'students', 'University Students']","['Digital Therapeutic Mobile App ""BioBase', 'mobile app (BioBase) and paired wearable device (BioBeam', 'biofeedback digital intervention']","['depression levels', 'anxiety', 'Stress and Improve Mental Wellbeing']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0443225', 'cui_str': 'Full (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant (finding)'}, {'cui': 'C0586740', 'cui_str': 'Able to read (finding)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C4505348', 'cui_str': 'Wearable Electronic Devices'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}]","[{'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",,0.0595304,"We found that a 4-weeks intervention with the BioBase programme significantly reduced anxiety and increased perceived wellbeing, with sustained effects at a 2-weeks follow-up.","[{'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Ponzo', 'Affiliation': 'BioBeats Group Ltd, London, United Kingdom.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Morelli', 'Affiliation': 'BioBeats Group Ltd, London, United Kingdom.'}, {'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Kawadler', 'Affiliation': 'BioBeats Group Ltd, London, United Kingdom.'}, {'ForeName': 'Nicola Rose', 'Initials': 'NR', 'LastName': 'Hemmings', 'Affiliation': 'BioBeats Group Ltd, London, United Kingdom.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Bird', 'Affiliation': 'Department of Experimental Psychology, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Plans', 'Affiliation': 'BioBeats Group Ltd, London, United Kingdom.'}]",JMIR mHealth and uHealth,['10.2196/17767']
295,31277077,Cardiorespiratory behavior of preterm infants receiving continuous positive airway pressure and high flow nasal cannula post extubation: randomized crossover study.,"BACKGROUND


Nasal continuous positive airway pressure (NCPAP) and high flow nasal cannula (HFNC) are modes of non-invasive respiratory support commonly used after extubation in extremely preterm infants. However, the cardiorespiratory physiology of these infants on each mode is unknown.
METHODS


Prospective, randomized crossover study in infants with birth weight ≤1250 g undergoing their first extubation attempt. NCPAP and HFNC were applied randomly for 45 min each, while ribcage and abdominal movements, electrocardiogram, oxygen saturation, and fraction of inspired oxygen (FiO 2 ) were recorded. Respiratory signals were analyzed using an automated method, and differences between NCPAP and HFNC features and changes in FiO 2  were analyzed.
RESULTS


A total of 30 infants with median [interquartile range] gestational age of 27 weeks [25.7, 27.9] and birth weight of 930 g [780, 1090] were studied. Infants were extubated at 5 days [2, 13] of life with 973 g [880, 1170] and three failed (10%). No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
CONCLUSIONS


In extremely preterm infants studied shortly after extubation, the use of HFNC was associated with longer respiratory pauses and higher FiO 2  requirements.",2020,"No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
","['extremely preterm infants', 'infants with birth weight ≤1250', 'preterm infants receiving continuous positive airway pressure and high flow nasal cannula post extubation', '30 infants with median [interquartile range] gestational age of 27 weeks [25.7, 27.9] and birth weight of 930\u2009g [780, 1090']","['HFNC', 'NCPAP and HFNC', 'Nasal continuous positive airway pressure (NCPAP) and high flow nasal cannula (HFNC']","['longer respiratory pauses', 'ribcage and abdominal movements, electrocardiogram, oxygen saturation, and fraction of inspired oxygen (FiO 2 ', 'cardiorespiratory behavior']","[{'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1258045', 'cui_str': 'Nasal Continuous Positive Airway Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0222762', 'cui_str': 'Thoracic Cage'}, {'cui': 'C1286159', 'cui_str': 'Movement of abdomen'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",30.0,0.118465,"No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
","[{'ForeName': 'Lara J', 'Initials': 'LJ', 'LastName': 'Kanbar', 'Affiliation': 'Department of Biomedical Engineering, Montreal, QC, Canada.'}, {'ForeName': 'Wissam', 'Initials': 'W', 'LastName': 'Shalish', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Latremouille', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Brown', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Kearney', 'Affiliation': 'Department of Biomedical Engineering, Montreal, QC, Canada.'}, {'ForeName': 'Guilherme M', 'Initials': 'GM', 'LastName': ""Sant'Anna"", 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada. guilherme.santanna@mcgill.ca.'}]",Pediatric research,['10.1038/s41390-019-0494-5']
296,32247649,Pharmacodynamic effects of vaporized and oral cannabidiol (CBD) and vaporized CBD-dominant cannabis in infrequent cannabis users.,"INTRODUCTION


The use and availability of oral and inhalable products containing cannabidiol (CBD) as the principal constituent has increased with expanded cannabis/hemp legalization. However, few controlled clinical laboratory studies have evaluated the pharmacodynamic effects of oral or vaporized CBD or CBD-dominant cannabis.
METHODS


Eighteen healthy adults (9 men; 9 women) completed four, double-blind, double-dummy, drug administration sessions. Sessions were separated by ≥1 week and included self-administration of 100 mg oral CBD, 100 mg vaporized CBD, vaporized CBD-dominant cannabis (100 mg CBD; 3.7 mg THC), and placebo. Study outcomes included: subjective drug effects, vital signs, cognitive/psychomotor performance, and whole blood THC and CBD concentrations.
RESULTS


Vaporized CBD and CBD-dominant cannabis increased ratings on several subjective items (e.g., Like Drug Effect) relative to placebo. Subjective effects did not differ between oral CBD and placebo and were generally higher for CBD-dominant cannabis compared to vaporized CBD. CBD did not increase ratings for several items typically associated with acute cannabis/THC exposure (e.g., Paranoid). Women reported qualitatively higher ratings for Pleasant Drug Effect than men after vaporized CBD and CBD-dominant cannabis use. CBD-dominant cannabis increased heart rate compared to placebo. Cognitive/psychomotor impairment was not observed in any drug condition.
CONCLUSIONS


Vaporized CBD and CBD-dominant cannabis produced discriminable subjective drug effects, which were sometimes stronger in women, but did not produce cognitive/psychomotor impairment. Subjective effects of oral CBD did not differ from placebo. Future research should further elucidate the subjective effects of various types of CBD products (e.g., inhaled, oral, topical), which appear to be distinct from THC-dominant products.",2020,Women reported qualitatively higher ratings for Pleasant Drug Effect than men after vaporized CBD and CBD-dominant cannabis use.,"['infrequent cannabis users', 'Eighteen healthy adults (9 men; 9 women']","['placebo', 'oral CBD', 'oral and inhalable products containing cannabidiol (CBD', 'CBD', 'vaporized and oral cannabidiol (CBD) and vaporized CBD-dominant cannabis', 'oral CBD, 100 mg vaporized CBD, vaporized CBD-dominant cannabis (100 mg CBD; 3.7 mg THC), and placebo']","['several subjective items', 'Subjective effects', 'Cognitive/psychomotor impairment', 'subjective drug effects, vital signs, cognitive/psychomotor performance, and whole blood THC and CBD concentrations', 'CBD-dominant cannabis', 'heart rate']","[{'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0424230', 'cui_str': 'Motor retardation'}, {'cui': 'C0728866', 'cui_str': 'drug effects'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0033923', 'cui_str': 'Psychomotor Performance'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",18.0,0.0867755,Women reported qualitatively higher ratings for Pleasant Drug Effect than men after vaporized CBD and CBD-dominant cannabis use.,"[{'ForeName': 'Tory R', 'Initials': 'TR', 'LastName': 'Spindle', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr., Baltimore, MD, 21224, USA. Electronic address: tspindle@jhmi.edu.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Cone', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr., Baltimore, MD, 21224, USA.'}, {'ForeName': 'Elia', 'Initials': 'E', 'LastName': 'Goffi', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr., Baltimore, MD, 21224, USA.'}, {'ForeName': 'Elise M', 'Initials': 'EM', 'LastName': 'Weerts', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr., Baltimore, MD, 21224, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Mitchell', 'Affiliation': 'RTI International, Research Triangle Park, 3040 East Cornwallis Rd., NC, 27709, USA.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Winecker', 'Affiliation': 'RTI International, Research Triangle Park, 3040 East Cornwallis Rd., NC, 27709, USA.'}, {'ForeName': 'George E', 'Initials': 'GE', 'LastName': 'Bigelow', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr., Baltimore, MD, 21224, USA.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Flegel', 'Affiliation': 'Substance Abuse and Mental Health Services Administration (SAMHSA), Division of Workplace Programs (DWP), 5600Fishers Lane, Rockville, MD, 20857, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Vandrey', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr., Baltimore, MD, 21224, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.107937']
297,32248227,Electrical Stimulation Therapies for Active Duty Military with Patellofemoral Pain Syndrome: A Randomized Trial.,"INTRODUCTION


Patellofemoral pain syndrome (PFPS) is a common musculoskeletal disorder among military service members that causes knee pain, quadriceps strength loss, and impaired motor performance in otherwise healthy individuals. PFPS poses a threat to the health, fitness, and subsequent readiness of the total force. The goal of rehabilitation for military service members with PFPS is to regain physical capacity of strength and function and to reduce pain, in order to restore readiness in this population. The randomized controlled trial reported here compared an active home exercise program (HEP) alone with three different electrical stimulation treatment regimens implemented concurrently with HEP postulated improvements in lower extremity strength and physical functional performance while also reducing pain in active duty military diagnosed with PFPS.
MATERIALS AND METHODS


After baseline testing, 130 active duty military members with PFPS were randomized to 1 of 4 treatment groups: (1) neuromuscular electrical stimulation (NMES) with HEP; (2) transcutaneous electrical nerve stimulation (TENS) with HEP; (3) combined NMES/TENS with HEP; (4) active HEP only. The primary outcome measure was degree of change in knee flexion and extension strength over 9 weeks. Secondary outcomes were physical functional performance and knee pain. The primary analyses used repeated measures, linear mixed-effects models with a random effect for subject, time as a continuous variable, group as a categorical variable, and a group and time interaction to test for differences in change over time among the groups.
RESULTS


All three electrical stimulation treatment groups improved in knee extension strength in the PFPS limb to a greater extent than the HEP alone group over the 9-week treatment period. The NMES and NMES/TENS groups improved to a greater extent than the HEP alone group in knee flexion strength in the PFPS limb. The reported pain improved over time for all treatment groups with no significant group differences. All three stimulation groups performed better on the 6-min walk test than the HEP alone group.
CONCLUSION


The findings from this study showed that all three electrical stimulation with HEP treatment groups showed greater improvement in strength compared to the HEP alone group. These findings could offer alternative forms of rehabilitation for AD military with PFPS as these treatment regimens can be easily implemented at home station or during deployment.",2020,The NMES and NMES/TENS groups improved to a greater extent than the HEP alone group in knee flexion strength in the PFPS limb.,"['otherwise healthy individuals', 'Active Duty Military with Patellofemoral Pain Syndrome', 'military service members with', 'active duty military diagnosed with PFPS', '130 active duty military members with PFPS']","['active home exercise program (HEP', 'Electrical Stimulation Therapies', 'neuromuscular electrical stimulation (NMES) with HEP; (2) transcutaneous electrical nerve stimulation (TENS) with HEP; (3) combined NMES/TENS with HEP; (4) active HEP only', 'HEP', 'PFPS']","['physical functional performance and knee pain', 'knee flexion strength', 'pain', 'knee extension strength', 'lower extremity strength and physical functional performance', 'strength', 'degree of change in knee flexion and extension strength']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C0877149', 'cui_str': 'Patellofemoral pain syndrome'}, {'cui': 'C0336524', 'cui_str': 'Military services member'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0680022', 'cui_str': 'Member of'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0162569', 'cui_str': 'Homozygous porphyria cutanea tarda'}, {'cui': 'C0013787', 'cui_str': 'Electrotherapy'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}]","[{'cui': 'C4704690', 'cui_str': 'Physical Functional Performance'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",130.0,0.0562604,The NMES and NMES/TENS groups improved to a greater extent than the HEP alone group in knee flexion strength in the PFPS limb.,"[{'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Talbot', 'Affiliation': 'Department of Neurology, College of Medicine, University of Tennessee Health Science Center, 855 Monroe Ave, Suite 415, Memphis, TN 38163.'}, {'ForeName': 'Zack', 'Initials': 'Z', 'LastName': 'Solomon', 'Affiliation': 'Physical Therapy Services, Dunham U.S. Army Health Clinic, Carlisle Barracks, PA 17013.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Webb', 'Affiliation': 'Byrd Clinic Physical Therapy, Fort Campbell, KY 42240.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Morrell', 'Affiliation': 'Department of Mathematics and Statistics, Loyola University Maryland, Baltimore, MD 21210-2699.'}, {'ForeName': 'E Jeffrey', 'Initials': 'EJ', 'LastName': 'Metter', 'Affiliation': 'Department of Neurology, College of Medicine, University of Tennessee Health Science Center, 855 Monroe Ave, Suite 415, Memphis, TN 38163.'}]",Military medicine,['10.1093/milmed/usaa037']
298,32242820,A Smartphone-Based Health Care Chatbot to Promote Self-Management of Chronic Pain (SELMA): Pilot Randomized Controlled Trial.,"BACKGROUND


Ongoing pain is one of the most common diseases and has major physical, psychological, social, and economic impacts. A mobile health intervention utilizing a fully automated text-based health care chatbot (TBHC) may offer an innovative way not only to deliver coping strategies and psychoeducation for pain management but also to build a working alliance between a participant and the TBHC.
OBJECTIVE


The objectives of this study are twofold: (1) to describe the design and implementation to promote the chatbot painSELfMAnagement (SELMA), a 2-month smartphone-based cognitive behavior therapy (CBT) TBHC intervention for pain self-management in patients with ongoing or cyclic pain, and (2) to present findings from a pilot randomized controlled trial, in which effectiveness, influence of intention to change behavior, pain duration, working alliance, acceptance, and adherence were evaluated.
METHODS


Participants were recruited online and in collaboration with pain experts, and were randomized to interact with SELMA for 8 weeks either every day or every other day concerning CBT-based pain management (n=59), or weekly concerning content not related to pain management (n=43). Pain-related impairment (primary outcome), general well-being, pain intensity, and the bond scale of working alliance were measured at baseline and postintervention. Intention to change behavior and pain duration were measured at baseline only, and acceptance postintervention was assessed via self-reporting instruments. Adherence was assessed via usage data.
RESULTS


From May 2018 to August 2018, 311 adults downloaded the SELMA app, 102 of whom consented to participate and met the inclusion criteria. The average age of the women (88/102, 86.4%) and men (14/102, 13.6%) participating was 43.7 (SD 12.7) years. Baseline group comparison did not differ with respect to any demographic or clinical variable. The intervention group reported no significant change in pain-related impairment (P=.68) compared to the control group postintervention. The intention to change behavior was positively related to pain-related impairment (P=.01) and pain intensity (P=.01). Working alliance with the TBHC SELMA was comparable to that obtained in guided internet therapies with human coaches. Participants enjoyed using the app, perceiving it as useful and easy to use. Participants of the intervention group replied with an average answer ratio of 0.71 (SD 0.20) to 200 (SD 58.45) conversations initiated by SELMA. Participants' comments revealed an appreciation of the empathic and responsible interaction with the TBHC SELMA. A main criticism was that there was no option to enter free text for the patients' own comments.
CONCLUSIONS


SELMA is feasible, as revealed mainly by positive feedback and valuable suggestions for future revisions. For example, the participants' intention to change behavior or a more homogenous sample (eg, with a specific type of chronic pain) should be considered in further tailoring of SELMA.
TRIAL REGISTRATION


German Clinical Trials Register DRKS00017147; https://tinyurl.com/vx6n6sx, Swiss National Clinical Trial Portal: SNCTP000002712; https://www.kofam.ch/de/studienportal/suche/70582/studie/46326.",2020,The intervention group reported no significant change in pain-related impairment (P=.68) compared to the control group postintervention.,"['Chronic Pain (SELMA', 'From May 2018 to August 2018, 311 adults downloaded the SELMA app, 102 of whom consented to participate and met the inclusion criteria', 'patients with ongoing or cyclic pain, and (2', 'Participants were recruited online and in collaboration with pain experts', 'average age of the women (88/102, 86.4%) and men (14/102, 13.6%) participating was 43.7 (SD 12.7) years']","['CBT-based pain management (n=59), or weekly concerning content not related to pain management', 'smartphone-based cognitive behavior therapy (CBT) TBHC intervention', 'SELMA', 'mobile health intervention utilizing a fully automated text-based health care chatbot (TBHC', 'Smartphone-Based Health Care Chatbot']","['Adherence', 'change behavior, pain duration, working alliance, acceptance, and adherence', 'pain-related impairment', 'Pain-related impairment (primary outcome), general well-being, pain intensity, and the bond scale of working alliance', 'pain intensity', 'change behavior and pain duration']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C4517546', 'cui_str': '12.7'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2939150', 'cui_str': 'General wellbeing'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.191358,The intervention group reported no significant change in pain-related impairment (P=.68) compared to the control group postintervention.,"[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Hauser-Ulrich', 'Affiliation': 'Department of Applied Psychology, University of Applied Sciences Zurich, Zurich, Switzerland.'}, {'ForeName': 'Hansjörg', 'Initials': 'H', 'LastName': 'Künzli', 'Affiliation': 'Department of Applied Psychology, University of Applied Sciences Zurich, Zurich, Switzerland.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Meier-Peterhans', 'Affiliation': 'Department Primary School, Division Education, Culture and Sports, Aarau, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kowatsch', 'Affiliation': 'Center for Digital Health Interventions, Institute of Technology Management, University of St Gallen, St Gallen, Switzerland.'}]",JMIR mHealth and uHealth,['10.2196/15806']
299,32242826,Effectiveness of Message Frame-Tailoring in a Web-Based Smoking Cessation Program: Randomized Controlled Trial.,"BACKGROUND


The content of online computer-tailored interventions is often determined to match an individual's characteristics, beliefs, and behavioral factors. These content-tailored interventions lead to better message processing and a higher likelihood of behavior change such as smoking cessation. However, a meta-analysis of online computer-tailored interventions showed that effect sizes, albeit positive, remain small, suggesting room for improvement. A promising strategy to enhance the effectiveness of online computer-tailored interventions is to tailor the message frame (ie, how a message is communicated) based on the preferred communication style of the user in addition to content-tailoring. One factor that determines an individual's communication style preference is the need for autonomy; some individuals prefer an autonomy-supportive communication style (offering choice and use of suggestive language), whereas others might prefer a directive communication style, which is replete with imperatives and does not provide choice. Tailoring how messages are presented (eg, based on the need for autonomy) is called message frame-tailoring.
OBJECTIVE


The aim of the present study was to test the effectiveness of message frame-tailoring based on the need for autonomy, in isolation and in combination with content-tailoring, within the context of an online computer-tailored smoking cessation intervention. The primary outcome measure was the 7-day point-prevalence of smoking abstinence. Secondary outcomes were perceived message relevance, self-determined motivation to quit smoking, and sociocognitive beliefs.
METHODS


A randomized controlled trial with a 2 (message frame-tailoring vs no message frame-tailoring) by 2 (content-tailoring vs no content-tailoring) design was conducted among adult smokers intending to quit smoking (N=273).
RESULTS


Structural equation modeling revealed that the content-tailored condition increased smoking abstinence rates 1 month after the start of the intervention (beta=.57, P=.02). However, neither message frame-tailoring nor its interaction with content-tailoring significantly predicted smoking abstinence. In our model, message frame-tailoring, content-tailoring, as well as their interaction significantly predicted perceived relevance of the smoking cessation messages, which consequently predicted self-determined motivation. In turn, self-determined motivation positively affected attitudes and self-efficacy for smoking cessation, but only self-efficacy consequently predicted smoking abstinence. Participants in the control condition perceived the highest level of message relevance (mean 4.78, SD 1.27). However, messages that were frame-tailored for individuals with a high need for autonomy in combination with content-tailored messages led to significantly higher levels of perceived message relevance (mean 4.83, SD 1.03) compared to those receiving content-tailored messages only (mean 4.24, SD 1.05, P=.003).
CONCLUSIONS


Message frame-tailoring based on the need for autonomy seems to be an effective addition to conventional content-tailoring techniques in online smoking cessation interventions for people with a high need for autonomy; however, this is not effective in its current form for people with a low need for autonomy.
TRIAL REGISTRATION


Dutch Trial Register (NL6512/NRT-6700); https://www.trialregister.nl/trial/6512.",2020,"RESULTS


Structural equation modeling revealed that the content-tailored condition increased smoking abstinence rates 1 month after the start of the intervention (beta=.57, P=.02).","['adult smokers intending to quit smoking (N=273', 'a Web-Based Smoking Cessation Program']",['2 (message frame-tailoring vs no message frame-tailoring) by 2 (content-tailoring vs no content-tailoring'],"['highest level of message relevance', '7-day point-prevalence of smoking abstinence', 'smoking abstinence rates', 'message relevance, self-determined motivation to quit smoking, and sociocognitive beliefs', 'smoking abstinence', 'levels of perceived message relevance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0512161,"RESULTS


Structural equation modeling revealed that the content-tailored condition increased smoking abstinence rates 1 month after the start of the intervention (beta=.57, P=.02).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Altendorf', 'Affiliation': 'Department of Communication Science, Amsterdam School of Communication Research, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Ciska', 'Initials': 'C', 'LastName': 'Hoving', 'Affiliation': 'Department of Health Promotion, Care and Public Health Research Institute, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Julia Cm', 'Initials': 'JC', 'LastName': 'Van Weert', 'Affiliation': 'Department of Communication Science, Amsterdam School of Communication Research, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Eline Suzanne', 'Initials': 'ES', 'LastName': 'Smit', 'Affiliation': 'Department of Communication Science, Amsterdam School of Communication Research, University of Amsterdam, Amsterdam, Netherlands.'}]",Journal of medical Internet research,['10.2196/17251']
300,31859205,Discharge Education Intervention to Reduce Anxiety and Depression in Cardiac Surgery Patients: A Randomized Controlled Study.,"PURPOSE


This study aimed to determine possible effects of a discharge education intervention on anxiety and depression among cardiac surgery patients in a private hospital in the city of Ordu, Turkey.
DESIGN


A randomized controlled trial.
METHODS


Thirty-three patients were placed in standard care group and 33 into standard care plus discharge education group. Patients in the discharge education group were provided an individual training from the first day of the hospital admission until the day of the discharge. The standard care group received usual discharge instructions.
FINDINGS


The Hospital Anxiety and Depression Scale-anxiety subscale scores were not significantly different between patients in the discharge and standard care groups (group: F = 1.58; P > .05). There was a significant difference for depression, indicating that the discharge education group had significantly lower depression than the standard care group (group: F = 19.23; P < .01).
CONCLUSIONS


Our findings supported that the discharge education intervention reduced depression in cardiac surgery patients.",2020,The Hospital Anxiety and Depression Scale-anxiety subscale scores were not significantly different between patients in the discharge and standard care groups (group:,"['Cardiac Surgery Patients', 'cardiac surgery patients in a private hospital in the city of Ordu, Turkey', 'Thirty-three patients were', 'cardiac surgery patients']","['Discharge Education Intervention', 'usual discharge instructions', 'discharge education intervention', 'placed in standard care group and 33 into standard care plus discharge education group']","['Anxiety and Depression', 'anxiety and depression', 'Hospital Anxiety and Depression Scale-anxiety subscale scores', 'depression']","[{'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033173', 'cui_str': 'Hospitals, Private'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}]",33.0,0.0859745,The Hospital Anxiety and Depression Scale-anxiety subscale scores were not significantly different between patients in the discharge and standard care groups (group:,"[{'ForeName': 'Yesim', 'Initials': 'Y', 'LastName': 'Yaman Aktas', 'Affiliation': 'Department of Surgical Nursing, Faculty of Health Sciences, Giresun University, Giresun, Turkey. Electronic address: yesimyaman28@hotmail.com.'}, {'ForeName': 'Hacer', 'Initials': 'H', 'LastName': 'Gok Uğur', 'Affiliation': 'Department of Public Health Nursing, Faculty of Health Sciences, Ordu University, Ordu, Turkey.'}, {'ForeName': 'Oya Sevcan', 'Initials': 'OS', 'LastName': 'Orak', 'Affiliation': 'Department of Psychiatric Nursing, Faculty of Health Sciences, Ondokuz Mayıs University, Samsun, Turkey.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.08.012']
301,31759833,The Effect of Virtual Reality and Kaleidoscope on Pain and Anxiety Levels During Venipuncture in Children.,"PURPOSE


The study aimed to determine the effect of two different distractions on pain perceptions and anxiety during venipuncture in children.
DESIGN


A randomized controlled study.
METHODS


A total of 139 children aged between 4 and 10 years were included in the study: 46 of them in virtual reality goggle group and 43 in the control group. An information form, the Children's Anxiety Scale, Visual Analogue Scale, and Wong-Baker Faces Pain Scale were used in the collection of data.
FINDINGS


Pain and anxiety scores were significantly lower in the virtual reality goggle and kaleidoscope group than in the control group (P < .000).
CONCLUSIONS


The use of virtual reality goggle and kaleidoscope methods during venipuncture are effective in reducing children's perception of pain and anxiety. The most effective method of reducing perception of pain and anxiety is using the virtual reality goggle.",2020,"FINDINGS


Pain and anxiety scores were significantly lower in the virtual reality goggle and kaleidoscope group than in the control group (P < .000).
","['children', '139 children aged between 4 and 10\xa0years were included in the study: 46 of them in virtual reality goggle group and 43 in the control group', 'Children']",['Virtual Reality and Kaleidoscope'],"['Pain and anxiety scores', 'pain perceptions and anxiety', ""Children's Anxiety Scale, Visual Analogue Scale, and Wong-Baker Faces Pain Scale"", 'pain and anxiety', ""children's perception of pain and anxiety"", 'Pain and Anxiety Levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0018020', 'cui_str': 'Goggles'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0222045'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0238749', 'cui_str': 'Baker, general (occupation)'}, {'cui': 'C0015468', 'cui_str': 'Face Pain'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}]",139.0,0.0506299,"FINDINGS


Pain and anxiety scores were significantly lower in the virtual reality goggle and kaleidoscope group than in the control group (P < .000).
","[{'ForeName': 'Tuba', 'Initials': 'T', 'LastName': 'Koç Özkan', 'Affiliation': 'Adiyaman University School of Health, Midwifery Department, Adiyaman, Turkey. Electronic address: tubakocozkan@gmail.com.'}, {'ForeName': 'Filiz', 'Initials': 'F', 'LastName': 'Polat', 'Affiliation': 'Adiyaman University School of Health, Midwifery Department, Adiyaman, Turkey.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.08.010']
302,31955895,Effects of Nonpharmacologic Distraction Methods on Children's Postoperative Pain-A Nonmatched Case-Control Study.,"PURPOSE


To investigate whether nonpharmacologic distraction as a supplement to conventional pain management can reduce children's assessment of pain in the postanesthesia care unit (PACU), and if parental assessment is a reliable proxy in assessing children's postoperative pain.
DESIGN


A nonmatched case-control study.
METHODS


The sample included 241 children aged 2 to 7 years assigned to one of five intervention groups or a control group. Children's and parents' assessments of pain were registered on arrival to PACU and repeated after 15, 30, and 45 minutes using the Wong-Baker FACES Pain Rating Scale.
FINDINGS


Positive effects of interventions were found in both children's and parental assessments. Results indicate a positive correlation between children's and parental assessments in children older than 3 years (P < .001).
CONCLUSIONS


Nonpharmacologic distraction is recommended as a supplement to conventional postoperative pain management. Parental assessment is a reliable proxy in assessing postoperative pain in children younger than 5 years.",2020,"Results indicate a positive correlation between children's and parental assessments in children older than 3 years (P < .001).
","[""Children's Postoperative Pain-A Nonmatched Case-Control Study"", '241 children aged 2 to 7\xa0years assigned to one of five intervention groups or a control group', 'children younger than 5\xa0years']","['nonpharmacologic distraction', 'Nonpharmacologic Distraction Methods']","['Baker FACES Pain Rating Scale', 'postoperative pain']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0007328', 'cui_str': 'Case-Referrent Studies'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C1369038', 'cui_str': 'Distraction (procedure)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0238749', 'cui_str': 'Baker, general (occupation)'}, {'cui': 'C0015468', 'cui_str': 'Face Pain'}, {'cui': 'C0222045'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]",241.0,0.0278362,"Results indicate a positive correlation between children's and parental assessments in children older than 3 years (P < .001).
","[{'ForeName': 'Susanne Winther', 'Initials': 'SW', 'LastName': 'Olsen', 'Affiliation': 'Department of Anesthesia and Intensive Care, Odense University Hospital, Denmark. Electronic address: Susanne.olsen@rsyd.dk.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Rosenkilde', 'Affiliation': 'Department of Anesthesia and Intensive Care, Odense University Hospital, Denmark.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Lauridsen', 'Affiliation': 'Business and Social Science, Department of Business and Economics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Dorthe', 'Initials': 'D', 'LastName': 'Hasfeldt', 'Affiliation': 'Department of Anesthesia and Intensive Care, Odense University Hospital, Denmark.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.09.007']
303,32246798,A Novel DBS Paradigm for Axial Features in Parkinson's Disease: A Randomized Crossover Study.,"BACKGROUND


High-frequency (130-185 Hz) deep brain stimulation (DBS) of the subthalamic nucleus is more effective for appendicular than axial symptoms in Parkinson's disease (PD). Low-frequency (60-80 Hz) stimulation (LFS) may reduce gait/balance impairment but typically results in worsening appendicular symptoms. We created a ""dual-frequency"" programming paradigm (interleave-interlink, IL-IL) to address both axial and appendicular symptoms. In IL-IL, 2 overlapping LFS programs are applied to the DBS lead, with the overlapping area focused on the optimal cathode. The nonoverlapping area (LFS) is thought to reduce gait/balance impairment, whereas the overlapping area (high-frequency stimulation, HFS) aims to control appendicular symptoms.
METHODS


We performed a randomized, double-blind crossover trial comparing patients' previously optimized IL-IL and conventional HFS paradigms. Each arm was 2 weeks in duration. The primary outcome measure was the patient/caregiver Modified Clinical Global Impression Severity (CGI-S). Secondary outcome measures included blinded motor evaluations, timed tests, patient/caregiver questionnaires, and Personal KinetiGraphs (PKG).
RESULTS


Twenty-five patients were enrolled, and 20 completed. The patient/caregiver CGI-S for gait/balance (P = 0.01) and appendicular symptom control (P = 0.001), and the blinded rater MDS-UPDRS-III (-5.22, P = 0.02), CGI-S gait/balance (P = 0.01), and CGI-S speech (P = 0.02) were better while on IL-IL. Scores on Parkinson's Disease Quality of Life (P = 0.002) and Freezing-of-Gait Questionnaires (P = 0.04) were better on IL-IL. The Timed-Up-and-Go was 9.8% faster (P = 0.01), with 11.8% reduction in steps (P = 0.001) on IL-IL. There was no difference in PKG bradykinesia (P = 0.18) or tremor (P = 0.23) between paradigms.
CONCLUSIONS


Our results prompt consideration of this novel programming paradigm (IL-IL) for PD patients with axial symptom impairment as a new treatment option for both axial and appendicular symptoms. © 2020 International Parkinson and Movement Disorder Society.",2020,Scores on Parkinson's Disease Quality of Life (P = 0.002) and Freezing-of-Gait Questionnaires (P = 0.04) were better on IL-IL.,"['Twenty-five patients were enrolled, and 20 completed', ""Parkinson's disease (PD"", ""Parkinson's Disease"", 'PD patients with axial symptom impairment', ""patients' previously optimized IL-IL and conventional HFS paradigms""]",['Low-frequency (60-80 Hz) stimulation (LFS'],"['Freezing-of-Gait Questionnaires', 'appendicular symptom control', 'CGI-S gait/balance', 'patient/caregiver Modified Clinical Global Impression Severity (CGI-S', 'blinded motor evaluations, timed tests, patient/caregiver questionnaires, and Personal KinetiGraphs (PKG', 'PKG bradykinesia', 'blinded rater MDS-UPDRS-III', ""Scores on Parkinson's Disease Quality of Life"", 'CGI-S speech']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C2745948', 'cui_str': 'Juvenile hyaline fibromatosis'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0085390', 'cui_str': 'Li-Fraumeni syndrome'}]","[{'cui': 'C0860515', 'cui_str': 'Freezing of gait'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0429928', 'cui_str': 'Test time'}, {'cui': 'C0010536', 'cui_str': 'Cyclic GMP-Dependent Protein Kinase'}, {'cui': 'C0233565', 'cui_str': 'Bradykinesia'}, {'cui': 'C0265219', 'cui_str': 'Miller Dieker syndrome'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]",25.0,0.356047,Scores on Parkinson's Disease Quality of Life (P = 0.002) and Freezing-of-Gait Questionnaires (P = 0.04) were better on IL-IL.,"[{'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Karl', 'Affiliation': 'Movement Disorder Section of Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Bichun', 'Initials': 'B', 'LastName': 'Ouyang', 'Affiliation': 'Movement Disorder Section of Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Goetz', 'Affiliation': 'Medtronic Brain Modulation, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Leo Verhagen', 'Initials': 'LV', 'LastName': 'Metman', 'Affiliation': 'Movement Disorder Section of Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USA.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28048']
304,31633896,Metoprolol for the Prevention of Acute Exacerbations of COPD.,"BACKGROUND


Observational studies suggest that beta-blockers may reduce the risk of exacerbations and death in patients with moderate or severe chronic obstructive pulmonary disease (COPD), but these findings have not been confirmed in randomized trials.
METHODS


In this prospective, randomized trial, we assigned patients between the ages of 40 and 85 years who had COPD to receive either a beta-blocker (extended-release metoprolol) or placebo. All the patients had a clinical history of COPD, along with moderate airflow limitation and an increased risk of exacerbations, as evidenced by a history of exacerbations during the previous year or the prescribed use of supplemental oxygen. We excluded patients who were already taking a beta-blocker or who had an established indication for the use of such drugs. The primary end point was the time until the first exacerbation of COPD during the treatment period, which ranged from 336 to 350 days, depending on the adjusted dose of metoprolol.
RESULTS


A total of 532 patients underwent randomization. The mean (±SD) age of the patients was 65.0±7.8 years; the mean forced expiratory volume in 1 second (FEV 1 ) was 41.1±16.3% of the predicted value. The trial was stopped early because of futility with respect to the primary end point and safety concerns. There was no significant between-group difference in the median time until the first exacerbation, which was 202 days in the metoprolol group and 222 days in the placebo group (hazard ratio for metoprolol vs. placebo, 1.05; 95% confidence interval [CI], 0.84 to 1.32; P = 0.66). Metoprolol was associated with a higher risk of exacerbation leading to hospitalization (hazard ratio, 1.91; 95% CI, 1.29 to 2.83). The frequency of side effects that were possibly related to metoprolol was similar in the two groups, as was the overall rate of nonrespiratory serious adverse events. During the treatment period, there were 11 deaths in the metoprolol group and 5 in the placebo group.
CONCLUSIONS


Among patients with moderate or severe COPD who did not have an established indication for beta-blocker use, the time until the first COPD exacerbation was similar in the metoprolol group and the placebo group. Hospitalization for exacerbation was more common among the patients treated with metoprolol. (Funded by the Department of Defense; BLOCK COPD ClinicalTrials.gov number, NCT02587351.).",2019,"Metoprolol was associated with a higher risk of exacerbation leading to hospitalization (hazard ratio, 1.91; 95% CI, 1.29 to 2.83).","['532 patients underwent randomization', 'patients between the ages of 40 and 85 years who had COPD to receive either a', 'patients who were already taking a beta-blocker or who had an established indication for the use of such drugs', 'patients with moderate or severe chronic obstructive pulmonary disease (COPD', 'Acute Exacerbations of COPD', 'patients with moderate or severe COPD']","['beta-blocker (extended-release metoprolol) or placebo', 'beta-blockers', 'placebo', 'metoprolol', 'metoprolol vs. placebo', 'Metoprolol']","['median time until the first exacerbation', 'frequency of side effects', 'time until the first COPD exacerbation', 'risk of exacerbations', 'time until the first exacerbation of COPD', 'Hospitalization for exacerbation', 'overall rate of nonrespiratory serious adverse events', 'mean forced expiratory volume']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease (disorder)'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}]",532.0,0.447618,"Metoprolol was associated with a higher risk of exacerbation leading to hospitalization (hazard ratio, 1.91; 95% CI, 1.29 to 2.83).","[{'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Voelker', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Surya P', 'Initials': 'SP', 'LastName': 'Bhatt', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Brenner', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Casaburi', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Carolyn E', 'Initials': 'CE', 'LastName': 'Come', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'J Allen D', 'Initials': 'JAD', 'LastName': 'Cooper', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Curtis', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Umur', 'Initials': 'U', 'LastName': 'Hatipoğlu', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Erika S', 'Initials': 'ES', 'LastName': 'Helgeson', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Vipul V', 'Initials': 'VV', 'LastName': 'Jain', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Kalhan', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kaminsky', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kaner', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Ken M', 'Initials': 'KM', 'LastName': 'Kunisaki', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Allison A', 'Initials': 'AA', 'LastName': 'Lambert', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Lammi', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lindberg', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Barry J', 'Initials': 'BJ', 'LastName': 'Make', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'McEvoy', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Ralph J', 'Initials': 'RJ', 'LastName': 'Panos', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Reed', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Scanlon', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Frank C', 'Initials': 'FC', 'LastName': 'Sciurba', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Peruvemba S', 'Initials': 'PS', 'LastName': 'Sriram', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Stringer', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Jeremy A', 'Initials': 'JA', 'LastName': 'Weingarten', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Wells', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Westfall', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Lazarus', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Connett', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1908142']
305,31972765,Treatment Trajectories During and After a Medication Trial for Opioid Use Disorder: Moving from Research as Usual to Treatment as Usual.,"OBJECTIVES


The effectiveness of treatment incorporating relapse prevention medications for opioid use disorder (OUD) is typically examined in research using rigidly predefined endpoints of success versus failure, usually over a single episode of care. But this perspective may not adequately portray the nonlinear trajectories typical of real-world treatment courses in this chronic, remitting, and relapsing disorder.
METHODS


This descriptive study examined 12-month treatment trajectories of n = 60 patients enrolled at a single site of a larger multisite randomized controlled trial examining the comparative effectiveness of buprenorphine versus extended-release naltrexone. While the parent study provided medication treatment through the research protocol for 6 months, this study documents treatment up to 12 months, including medications, provided through standard community resources (treatment as usual) outside of the protocol.
RESULTS


Some patients continued medications past the end of the study intervention, whereas others did not. Some patients initiated medications other than the one assigned by the study. Some patients switched from 1 medication to the other. Many patients returned to treatment after 1 or more periods of dropout and/or relapse. Patients utilized multiple episodes of bed-based care, including short-term acute residential and long-term residential treatment, and also recovery housing supports. Described trajectories are also depicted graphically. At 12 months, while rates of continuous treatment retention were low (8%), rates of cross-sectional treatment engagement including return to treatment after drop out were higher (35%).
CONCLUSIONS


This description of nonlinear treatment trajectories highlights the potential benefits of flexibility and optimism in the promotion of re-engagement, despite interim outcomes that might traditionally be considered ""failure"" endpoints.",2020,"At 12 months, while rates of continuous treatment retention were low (8%), rates of cross-sectional treatment engagement including return to treatment after drop out were higher (35%).
","['n\u200a=\u200a60 patients enrolled at a single site', 'Patients utilized multiple episodes of bed-based care, including short-term acute residential and long-term residential treatment, and also recovery housing supports']",['buprenorphine versus extended-release naltrexone'],"['rates of continuous treatment retention', 'rates of cross-sectional treatment engagement including return to treatment']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0565960', 'cui_str': 'Multiple episode (qualifier value)'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0035189', 'cui_str': 'Residential Treatment'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}]",60.0,0.0388449,"At 12 months, while rates of continuous treatment retention were low (8%), rates of cross-sectional treatment engagement including return to treatment after drop out were higher (35%).
","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Fishman', 'Affiliation': 'Maryland Treatment Centers, Baltimore, MD (MF, RB, MR); Johns Hopkins University School of Medicine, Baltimore, MD (MF); University of Texas Southwestern Medical Center, Dallas, TX (HTV); New York University School of Medicine, New York, NY (JR, JL); New York State Psychiatric Institute, Columbia University Medical Center, New York, NY (EN).'}, {'ForeName': 'Hoa T', 'Initials': 'HT', 'LastName': 'Vo', 'Affiliation': ''}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Burgower', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ruggiero', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': ''}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Nunes', 'Affiliation': ''}]",Journal of addiction medicine,['10.1097/ADM.0000000000000592']
306,32238335,Effectiveness of One-Way Text Messaging on Attendance to Follow-Up Cervical Cancer Screening Among Human Papillomavirus-Positive Tanzanian Women (Connected2Care): Parallel-Group Randomized Controlled Trial.,"BACKGROUND


Rapid human papillomavirus (HPV) DNA testing is an emerging cervical cancer screening strategy in resource-limited countries, yet it requires follow-up of women who test HPV positive.
OBJECTIVE


This study aimed to determine if one-way text messages improved attendance to a 14-month follow-up cervical cancer screening among HPV-positive women.
METHODS


This multicenter, parallel-group randomized controlled trial was conducted at 3 hospitals in Tanzania. Eligible participants were aged between 25 and 60 years, had tested positive to a rapid HPV test during a patient-initiated screening, had been informed of their HPV result, and had a private mobile phone with a valid number. Participants were randomly assigned in a 1:1 ratio to the intervention or control group through an incorporated algorithm in the text message system. The intervention group received one-way text messages, and the control group received no text messages. The primary outcome was attendance at a 14-month health provider-initiated follow-up screening. Participants were not blinded, but outcome assessors were. The analysis was based on intention to treat.
RESULTS


Between August 2015 and July 2017, 4080 women were screened for cervical cancer, of which 705 were included in this trial-358 women were allocated to the intervention group, and 347 women were allocated to the control group. Moreover, 16 women were excluded before the analysis because they developed cervical cancer or died (8 from each group). In the intervention group, 24.0% (84/350) women attended their follow-up screening, and in the control group, 23.8% (80/335) women attended their follow-up screening (risk ratio 1.02, 95% CI 0.79-1.33).
CONCLUSIONS


Attendance to a health provider-initiated follow-up cervical cancer screening among HPV-positive women was strikingly low, and one-way text messages did not improve the attendance rate. Implementation of rapid HPV testing as a primary screening method at the clinic level entails the challenge of ensuring a proper follow-up of women.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02509702; https://clinicaltrials.gov/ct2/show/NCT02509702.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/10.2196/15863.",2020,"This study aimed to determine if one-way text messages improved attendance to a 14-month follow-up cervical cancer screening among HPV-positive women.
","['16 women were excluded before the analysis because they developed cervical cancer or died (8 from each group', 'Human Papillomavirus-Positive Tanzanian Women', 'Between August 2015 and July 2017', 'Eligible participants were aged between 25 and 60 years, had tested positive to a rapid HPV test during a patient-initiated screening, had been informed of their HPV result, and had a private mobile phone with a valid number', 'Connected2Care', '3 hospitals in Tanzania', '4080 women were screened for cervical cancer, of which 705 were included in this trial-358 women were allocated to the intervention group, and 347 women', 'HPV-positive women']","['control group received no text messages', 'One-Way Text Messaging', 'intervention or control group through an incorporated algorithm in the text message system']","['attendance at a 14-month health provider-initiated follow-up screening', 'attendance rate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1998726', 'cui_str': 'Is informed'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",4080.0,0.355157,"This study aimed to determine if one-way text messages improved attendance to a 14-month follow-up cervical cancer screening among HPV-positive women.
","[{'ForeName': 'Ditte S', 'Initials': 'DS', 'LastName': 'Linde', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Marianne S', 'Initials': 'MS', 'LastName': 'Andersen', 'Affiliation': 'Department of Medical Endocrinology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Mwaiselage', 'Affiliation': 'Department for Cancer Prevention Services, Ocean Road Cancer Institute, Dar es Salaam, United Republic of Tanzania.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Manongi', 'Affiliation': 'Department of Public Health, Kilimanjaro Christian Medical University College, Moshi, United Republic of Tanzania.'}, {'ForeName': 'Susanne K', 'Initials': 'SK', 'LastName': 'Kjaer', 'Affiliation': 'Department of Gynaecology, Rigshospitalet University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Rasch', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}]",Journal of medical Internet research,['10.2196/15863']
307,32238338,Optimizing Text Messages to Promote Engagement With Internet Smoking Cessation Treatment: Results From a Factorial Screening Experiment.,"BACKGROUND


Smoking remains a leading cause of preventable death and illness. Internet interventions for smoking cessation have the potential to significantly impact public health, given their broad reach and proven effectiveness. Given the dose-response association between engagement and behavior change, identifying strategies to promote engagement is a priority across digital health interventions. Text messaging is a proven smoking cessation treatment modality and a powerful strategy to increase intervention engagement in other areas of health, but it has not been tested as an engagement strategy for a digital cessation intervention.
OBJECTIVE


This study examined the impact of 4 experimental text message design factors on adult smokers' engagement with an internet smoking cessation program.
METHODS


We conducted a 2×2×2×2 full factorial screening experiment wherein 864 participants were randomized to 1 of 16 experimental conditions after registering with a free internet smoking cessation program and enrolling in its automated text message program. Experimental factors were personalization (on/off), integration between the web and text message platforms (on/off), dynamic tailoring of intervention content based on user engagement (on/off), and message intensity (tapered vs abrupt drop-off). Primary outcomes were 3-month measures of engagement (ie, page views, time on site, and return visits to the website) as well as use of 6 interactive features of the internet program. All metrics were automatically tracked; there were no missing data.
RESULTS


Main effects were detected for integration and dynamic tailoring. Integration significantly increased interactive feature use by participants, whereas dynamic tailoring increased the number of features used and page views. No main effects were found for message intensity or personalization alone, although several synergistic interactions with other experimental features were observed. Synergistic effects, when all experimental factors were active, resulted in the highest rates of interactive feature use and the greatest proportion of participants at high levels of engagement. Measured in terms of standardized mean differences (SMDs), effects on interactive feature use were highest for Build Support System (SMD 0.56; 95% CI 0.27 to 0.81), Choose Quit Smoking Aid (SMD 0.38; 95% CI 0.10 to 0.66), and Track Smoking Triggers (SMD 0.33; 95% CI 0.05 to 0.61). Among the engagement metrics, the largest effects were on overall feature utilization (SMD 0.33; 95% CI 0.06 to 0.59) and time on site (SMD 0.29; 95% CI 0.01 to 0.57). As no SMD &gt;0.30 was observed for main effects on any outcome, results suggest that for some outcomes, the combined intervention was stronger than individual factors alone.
CONCLUSIONS


This factorial experiment demonstrates the effectiveness of text messaging as a strategy to increase engagement with an internet smoking cessation intervention, resulting in greater overall intervention dose and greater exposure to the core components of tobacco dependence treatment that can promote abstinence.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02585206; https://clinicaltrials.gov/ct2/show/NCT02585206.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1136/bmjopen-2015-010687.",2020,"No main effects were found for message intensity or personalization alone, although several synergistic interactions with other experimental features were observed.","[""adult smokers' engagement with an internet smoking cessation program"", '864 participants were randomized to 1 of 16 experimental conditions after registering with a']",['free internet smoking cessation program and enrolling in its automated text message program'],"['3-month measures of engagement (ie, page views, time on site, and return visits to the website) as well as use of 6 interactive features of the internet program', 'Synergistic effects', 'Choose Quit Smoking Aid', 'overall feature utilization', 'Track Smoking Triggers']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0013862', 'cui_str': 'Polyacrylamide gel electrophoresis'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}]",864.0,0.0987372,"No main effects were found for message intensity or personalization alone, although several synergistic interactions with other experimental features were observed.","[{'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Graham', 'Affiliation': 'Innovations Center, Truth Initiative, Washington, DC, United States.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Papandonatos', 'Affiliation': 'Center for Statistical Sciences, Brown University, Providence, RI, United States.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Jacobs', 'Affiliation': 'Innovations Center, Truth Initiative, Washington, DC, United States.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Amato', 'Affiliation': 'Innovations Center, Truth Initiative, Washington, DC, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cha', 'Affiliation': 'Innovations Center, Truth Initiative, Washington, DC, United States.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Cohn', 'Affiliation': 'Oklahoma Tobacco Research Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States.'}, {'ForeName': 'Lorien C', 'Initials': 'LC', 'LastName': 'Abroms', 'Affiliation': 'Department of Prevention and Community Health, Milken Institute School of Public Health, The George Washington University, Washington, DC, United States.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Whittaker', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, Auckland, New Zealand.'}]",Journal of medical Internet research,['10.2196/17734']
308,31026056,Exposure to mild intermittent hypoxia increases loop gain and the arousal threshold in participants with obstructive sleep apnoea.,"KEY POINTS


Repeated daily mild intermittent hypoxia has been endorsed as a therapy to promote the recovery of respiratory and limb motor dysfunction. One possible side-effect of this therapy is an increase in apnoeic event number and duration, which is particularly relevant to participants with motor disorders coupled with an increased incidence of sleep apnoea. In this study, we report that increases in apnoeic event number and duration, following exposure to daily intermittent hypoxia, are the result of an increase in respiratory loop gain and the arousal threshold, in participants with obstructive sleep apnoea. Daily exposure to mild intermittent hypoxia also led to an increase in the ventilatory response to arousal. Accordingly, individuals with motor disorders receiving mild intermittent hypoxia as a therapy should be screened for the presence of sleep apnoea, and if present, administration of intermittent hypoxia during hours of wakefulness should be combined with continuous positive airway pressure treatment during sleep.
ABSTRACT


We determined if exposure to mild intermittent hypoxia (MIH) causes an increase in loop gain (LG) and the arousal threshold (AT) during non-rapid eye movement (NREM) sleep. Male participants with obstructive sleep apnoea (apnoea-hypopnoea index > 5 events/h), matched for age, body mass index and race were divided into two groups (n = 13 in each group). Following a baseline sleep study, one group was exposed to twelve 4-min episodes of hypoxia each day for 10 days and the other group to a sham protocol (SP). On Days 1 and 10, a sleep study was completed following exposure to MIH or the SP. For each sleep study, LG and the AT were measured during NREM sleep, using a model-based approach, and expressed as a fraction of baseline measures. LG increased after exposure to MIH (Day 1: 1.11 ± 0.03, P = 0.002, Day 10: 1.17 ± 0.05, P = 0.001), but not after the SP (Day 1: 1.03 ± 0.04, P = 1.0, Day 10: 1.0 ± 0.02, P = 1.0). AT also increased after exposure to MIH (Day 1: 1.13 ± 0.05, P = 0.01, Day 10: 1.19 ± 0.08, P = 0.05) but not after the SP (Day 1: 1.04 ± 0.05, P = 0.6, Day 10: 0.96 ± 0.04, P = 1.0). Our results might account for increases in apnoea frequency and duration previously observed during NREM sleep following exposure to MIH. Our results also have implications for the use of MIH as a therapeutic modality.",2019,"AT also increased after exposure to MIH (Day 1: 1.13 ± 0.05, P = 0.01, Day 10: 1.19 ± 0.08, P = 0.05) but not after the SP (Day 1: 1.04 ± 0.05, P = 0.6, Day 10: 0.96 ± 0.04, P = 1.0).","['participants with motor disorders', 'individuals with motor disorders receiving mild intermittent hypoxia', 'Male participants with obstructive sleep apnoea (apnoea-hypopnoea index >\xa05\xa0events/h), matched for age, body mass index and race', 'participants with obstructive sleep apnoea']",[],"['LG', 'ventilatory response to arousal']","[{'cui': 'C0221163', 'cui_str': 'Motor Disorders'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}]",[],"[{'cui': 'C0003808', 'cui_str': 'Arousal'}]",,0.0436555,"AT also increased after exposure to MIH (Day 1: 1.13 ± 0.05, P = 0.01, Day 10: 1.19 ± 0.08, P = 0.05) but not after the SP (Day 1: 1.04 ± 0.05, P = 0.6, Day 10: 0.96 ± 0.04, P = 1.0).","[{'ForeName': 'Raichel M', 'Initials': 'RM', 'LastName': 'Alex', 'Affiliation': 'John D. Dingell Veterans Affairs Medical Center, Detroit, MI, 48201, USA.'}, {'ForeName': 'Gino S', 'Initials': 'GS', 'LastName': 'Panza', 'Affiliation': 'John D. Dingell Veterans Affairs Medical Center, Detroit, MI, 48201, USA.'}, {'ForeName': 'Huzaifa', 'Initials': 'H', 'LastName': 'Hakim', 'Affiliation': 'John D. Dingell Veterans Affairs Medical Center, Detroit, MI, 48201, USA.'}, {'ForeName': 'M Safwan', 'Initials': 'MS', 'LastName': 'Badr', 'Affiliation': 'John D. Dingell Veterans Affairs Medical Center, Detroit, MI, 48201, USA.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Edwards', 'Affiliation': 'Sleep and Circadian Medicine Laboratory, Department of Physiology Monash University, Melbourne, Australia.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Sands', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Jason H', 'Initials': 'JH', 'LastName': 'Mateika', 'Affiliation': 'John D. Dingell Veterans Affairs Medical Center, Detroit, MI, 48201, USA.'}]",The Journal of physiology,['10.1113/JP277711']
309,29179562,Effects of Support Interventions in Women Hospitalized With Preterm Labor.,"This study was to examine the effects of support interventions on anxiety, depression, and quality of life in women hospitalized with preterm labor. A randomized, single-blind experimental design was used. Participants were recruited from maternity wards of one medical center in Taiwan. The control group ( n  = 103) received routine nursing care, and intervention group ( n  = 140) received interventional support during hospitalization. The Beck Anxiety Inventory, Edinburgh Postnatal Depression Scale, and Quality of Life Enjoyment and Satisfaction Questionnaire were used at admission and 2 weeks of hospitalization. For the control group, anxiety and depression scores increased significantly and quality of life decreased 2 weeks after hospitalization. Participants who received 2 weeks of support intervention had significantly lower anxiety and depression scores than controls. Thus, clinical nurses can offer support interventions to improve anxiety and depression for women with preterm labor during hospitalization.",2019,Participants who received 2 weeks of support intervention had significantly lower anxiety and depression scores than controls.,"['women with preterm labor during hospitalization', 'Women Hospitalized With Preterm Labor', 'Participants were recruited from maternity wards of one medical center in Taiwan', 'women hospitalized with preterm labor']","['routine nursing care, and intervention group ( n  = 140) received interventional support during hospitalization', 'support interventions', 'support intervention', 'Support Interventions']","['anxiety and depression', 'anxiety, depression, and quality of life', 'quality of life', 'Beck Anxiety Inventory, Edinburgh Postnatal Depression Scale, and Quality of Life Enjoyment and Satisfaction Questionnaire', 'anxiety and depression scores']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0022876', 'cui_str': 'Preterm Labor'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0028682', 'cui_str': 'Nursing Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034380'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory (assessment scale)'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0296769,Participants who received 2 weeks of support intervention had significantly lower anxiety and depression scores than controls.,"[{'ForeName': 'Mei-Hua', 'Initials': 'MH', 'LastName': 'Kao', 'Affiliation': '1 Mackay Junior College of Medicine, Nursing, and Management, Sanzhi, New Taipei City, Taiwan.'}, {'ForeName': 'Pi-Feng', 'Initials': 'PF', 'LastName': 'Hsu', 'Affiliation': '2 Mackay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Sheng-Fang', 'Initials': 'SF', 'LastName': 'Tien', 'Affiliation': '1 Mackay Junior College of Medicine, Nursing, and Management, Sanzhi, New Taipei City, Taiwan.'}, {'ForeName': 'Chie-Pein', 'Initials': 'CP', 'LastName': 'Chen', 'Affiliation': '2 Mackay Memorial Hospital, Taipei, Taiwan.'}]",Clinical nursing research,['10.1177/1054773817744323']
310,29276844,Long-Term Lifestyle Intervention in Elderly With Metabolic Syndrome.,"The purpose of this study was to examine the effects of a long-term community-based lifestyle intervention on the biochemical indicators and prevalence of metabolic syndrome among elderly adults. This was a randomized controlled trial in northern Taiwan from August 2013 to February 2015. Sixty-nine elderly adults participated in this study. There were three measurements. The experimental group participated in exercise and diet interventions. The control group participated in the exercise intervention. Repeated measurement and ANCOVA were performed to evaluate the effectiveness. After 18 months, body weight (1.06 kg), body mass index (1.21 kg/m 2 ), waist circumference (3.32 cm), blood pressure, and prevalence (30.4%) of metabolic syndrome were significantly reduced in all subjects. There were significant differences in waist circumference and high-density lipoprotein cholesterol between the two groups. This intervention can lower the indicators and prevalence of metabolic syndrome. Exercise and diet interventions could promote further metabolic changes.",2019,"After 18 months, body weight (1.06 kg), body mass index (1.21 kg/m 2 ), waist circumference (3.32 cm), blood pressure, and prevalence (30.4%) of metabolic syndrome were significantly reduced in all subjects.","['Sixty-nine elderly adults', 'northern Taiwan from August 2013 to February 2015', 'elderly adults', 'Elderly With Metabolic Syndrome']","['exercise intervention', 'long-term community-based lifestyle intervention', 'Long-Term Lifestyle Intervention', 'exercise and diet interventions', 'Exercise and diet interventions']","['metabolic syndrome', 'waist circumference', 'blood pressure, and prevalence', 'waist circumference and high-density lipoprotein cholesterol', 'body mass index', 'body weight']","[{'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",69.0,0.0212852,"After 18 months, body weight (1.06 kg), body mass index (1.21 kg/m 2 ), waist circumference (3.32 cm), blood pressure, and prevalence (30.4%) of metabolic syndrome were significantly reduced in all subjects.","[{'ForeName': 'Shu-Hung', 'Initials': 'SH', 'LastName': 'Chang', 'Affiliation': '1 Chang Gung University of Science and Technology, Taoyuan City, Taiwan (R.O.C.).'}, {'ForeName': 'Nai-Hui', 'Initials': 'NH', 'LastName': 'Chien', 'Affiliation': '1 Chang Gung University of Science and Technology, Taoyuan City, Taiwan (R.O.C.).'}, {'ForeName': 'Ching-Yi', 'Initials': 'CY', 'LastName': 'Yu', 'Affiliation': '2 Chang Gung Memorial Hospital, Taoyuan City, Taiwan (R.O.C.).'}]",Clinical nursing research,['10.1177/1054773817749923']
311,32241214,A Randomized Controlled Trial to Increase Diabetic Retinopathy Screening by a Community-Based Health Insurance Plan in Central Texas - 2017.,"PURPOSE


Diabetic retinopathy is a leading cause of blindness worldwide. In the United States, the prevalence of diabetic retinopathy is 26% - 33%. Providing preventive care to individuals with diabetes is important to prevent microvascular complications in the eye. This study reports on the results of a randomized controlled trial to determine how using specific cues to action combined with the provision of a free eye exam might positively influence the rate of diabetic retinopathy screening among individuals with diabetes.
METHODS


Individuals were eligible to participate in this campaign if they had a diagnosis of type 2 diabetes or were prescribed a diabetes drug, were members of the health insurance plan during the intervention period and had no evidence of receiving a retinal eye exam prior to the campaign period. The six-week campaign period started on September 19, 2017 and ended on October 31, 2017. A total of 1,454 individuals with type 2 diabetes were randomly assigned to a control group or to one of three intervention groups. Each intervention group included the provision of a free eye exam.
RESULTS


A total of 148 (10.1%) individuals obtained a retinal eye exam during the six-week campaign period with 38 persons (6.8%) in the control group, 38 (15.3%) in the incentive group, 41 (16.5%) in the education group, and 31 (12.4%) in the incentive and education group. Individual intervention comparisons with the referent group yielded statistical significance using the adjusted pairwise alpha of  P  = .008 for the incentive group (RR = 2.08; 95% CI, 1.36-3.19;  P  =.0006) and for the education group (RR = 2.23; 95% CI, 1.47-3.39;  P  =.0001), but not in the incentive plus education group (RR = 1.73; 95% CI, 1.10-2.73;  P  =.017).
CONCLUSION


This study supports the use of targeted cues to action combined with the provision of a free eye exam to increase the rates of diabetic retinopathy screening among individuals with diabetes who have health insurance coverage under the Affordable Care Act in a Central Texas population.",2020,"Individual intervention comparisons with the referent group yielded statistical significance using the adjusted pairwise alpha of  P  = .008 for the incentive group (RR = 2.08; 95% CI, 1.36-3.19;  P  =.0006) and for the education group (RR = 2.23; 95% CI, 1.47-3.39;  P  =.0001), but not in the incentive plus education group (RR = 1.73; 95% CI, 1.10-2.73;  P  =.017).","['Methods : Individuals were eligible to participate in this campaign if they had a diagnosis of type 2 diabetes or were prescribed a diabetes drug, were members of the health insurance plan during the intervention period and had no evidence of receiving a retinal eye exam prior to the campaign period', '1,454 individuals with type 2 diabetes', 'Diabetic Retinopathy Screening by a Community-Based Health Insurance Plan in Central Texas - 2017', 'individuals with diabetes', 'individuals with diabetes who have health insurance coverage under the Affordable Care Act in a Central Texas population']",[],"['retinal eye exam', 'diabetic retinopathy', 'diabetic retinopathy screening']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332125', 'cui_str': 'No evidence of'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1277181', 'cui_str': 'Diabetic retinopathy screening'}, {'cui': 'C5197711', 'cui_str': 'Community-Based Health Financing'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C2936611', 'cui_str': 'Affordable Care Act (ACA)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],"[{'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C1277181', 'cui_str': 'Diabetic retinopathy screening'}]",1454.0,0.0629138,"Individual intervention comparisons with the referent group yielded statistical significance using the adjusted pairwise alpha of  P  = .008 for the incentive group (RR = 2.08; 95% CI, 1.36-3.19;  P  =.0006) and for the education group (RR = 2.23; 95% CI, 1.47-3.39;  P  =.0001), but not in the incentive plus education group (RR = 1.73; 95% CI, 1.10-2.73;  P  =.017).","[{'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Litaker', 'Affiliation': 'Office of Population Health and Science, The Litaker Group , Austin, Texas, USA.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Tamez', 'Affiliation': 'Population Health, Sendero Health Plans , Austin, Texas, USA.'}, {'ForeName': 'Christian Bryan', 'Initials': 'CB', 'LastName': 'Palma', 'Affiliation': 'Population Health, Sendero Health Plans , Austin, Texas, USA.'}, {'ForeName': 'Wesley', 'Initials': 'W', 'LastName': 'Durkalski', 'Affiliation': 'Chief Executive Officer, Sendero Health Plans , Austin, Texas, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Human Ecology, Public Health Program, University of Texas at Austin , Austin, Texas, USA.'}]",Ophthalmic epidemiology,['10.1080/09286586.2020.1746360']
312,32236329,The effect of home exercise on the posture and mobility of people with HAM/TSP: a randomized clinical trial.,"BACKGROUND


Physical therapy has positive results in people with tropical spastic paraparesis (TSP). However, mobility and distance from rehabilitation centers limit the participation in outpatient programs.
OBJECTIVE


To evaluate the impact of a home exercise program on the posture and functional mobility of people with TSP.
METHODS


A randomized controlled trial comparing three groups of people who performed guided exercises from a guidebook for six months: supervised (SG), unsupervised (WG), and control (CG). Primary outcomes: postural angles (SAPO®) and functional mobility (TUG).
SECONDARY OUTCOMES


gait parameters (CVMob®).
RESULTS


The protocol described in the guidebook improved postural angles and functional mobility. There were also positive gait parameter effects (p<0.05). SG presented better responses than WG did, but both were preferable to CG.
CONCLUSION


Home exercises oriented by a guidebook may benefit posture, functional mobility and gait parameters in people with TSP, and physiotherapist supervision can ensure better results.",2020,There were also positive gait parameter effects (p<0.05).,"['people with HAM/TSP', 'people with tropical spastic paraparesis (TSP', 'people with TSP']","['home exercise program', 'home exercise', 'guided exercises from a guidebook for six months: supervised (SG), unsupervised (WG), and control (CG']","['gait parameters (CVMob®', 'postural angles (SAPO®) and functional mobility (TUG', 'postural angles and functional mobility', 'positive gait parameter effects']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0076560', 'cui_str': 'Thrombospondin'}]","[{'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0376666', 'cui_str': 'Guidebooks'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.131953,There were also positive gait parameter effects (p<0.05).,"[{'ForeName': 'Renata de Sousa', 'Initials': 'RS', 'LastName': 'Mota', 'Affiliation': 'Centro de Ciência e Tecnologia em Energia e Sustentabilidade, Universidade Federal do Recôncavo da Bahia, Feira de Santana, BA, Brazil.'}, {'ForeName': 'Maíra Carvalho', 'Initials': 'MC', 'LastName': 'Macêdo', 'Affiliation': 'Fundação para Neurologia e Neurocirurgia, Instituto do Cérebro, Salvador, BA, Brazil.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Corradini', 'Affiliation': 'Universidade de Campinas, Campinas, SP, Brazil.'}, {'ForeName': 'Naiane Araújo', 'Initials': 'NA', 'LastName': 'Patrício', 'Affiliation': 'Departamento de Tecnologias de Saúde, Escola Bahiana de Medicina e Saúde Pública, Salvador, BA, Brazil.'}, {'ForeName': 'Abrahão Fontes', 'Initials': 'AF', 'LastName': 'Baptista', 'Affiliation': 'Centro de Matemática, Computação e Cognição, Universidade Federal do ABC, São Paulo, SP, Brazil.'}, {'ForeName': 'Katia Nunes', 'Initials': 'KN', 'LastName': 'Sá', 'Affiliation': 'Departamento de Fisioterapia, Escola Bahiana de Medicina e Saúde Pública, Salvador, BA, Brazil.'}]",Arquivos de neuro-psiquiatria,['10.1590/0004-282x20190169']
313,32193729,Transgender Women's Experiences Using a Home HIV-Testing Kit for Partner-Testing.,"HIV partner-testing (PT) may represent a unique and empowering HIV prevention strategy for groups that face structural and institutional barriers to HIV testing and care, including transgender women. We report on in-depth interviews (IDIs) with N = 10 transgender women who used HIV self-test kits for three months to screen potential sexual partners in a randomized controlled trial (iSUM; ""I'll Show You Mine"") that took place in New York City and San Juan, Puerto Rico. Participants were assigned to intervention (supplied with 10 self-test kits immediately) or control groups (received 6 test kits after 3 months). We conducted IDIs with the first N = 10 transgender women to enroll in the intervention group after three months in the study (after participants used kits with partners) to understand their experiences. Themes discussed in IDIs included: partners' reaction to HIV testing, participants' reactions to partners' test results or refusal to test, partners' own reaction to their test results, and decision-making around test use. Data were independently analyzed by two coders. Overwhelmingly, participants' experiences with PT was positive. Participants reported kits were convenient and acceptable to most partners. Transgender women felt that PT could pose additional risk for them; one woman experienced violence related to kit use. Furthermore, the availability of kits appeared to encourage participants and their partners to think about their HIV status and, in some cases, modify sexual behavior. Work suggests that HIV PT could be a viable risk-reduction strategy for transgender women.",2020,Participants were assigned to intervention (supplied with 10 self-test kits immediately) or control groups (received 6 test kits after 3 months).,"['10 transgender women who used HIV self-test kits for three months to screen potential sexual partners', ""Transgender Women's Experiences Using a Home HIV-Testing Kit for Partner-Testing""]",['HIV partner-testing (PT'],[],"[{'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1272835', 'cui_str': 'Test kit'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0036911', 'cui_str': 'Sexual Partners'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0682323', 'cui_str': 'Companion'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0682323', 'cui_str': 'Companion'}]",[],10.0,0.0227863,Participants were assigned to intervention (supplied with 10 self-test kits immediately) or control groups (received 6 test kits after 3 months).,"[{'ForeName': 'Christine Tagliaferri', 'Initials': 'CT', 'LastName': 'Rael', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA. Cr2857@cumc.columbia.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Giguere', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Lopez-Rios', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Lentz', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA.'}, {'ForeName': 'Iván C', 'Initials': 'IC', 'LastName': 'Balán', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Sheinfil', 'Affiliation': 'Department of Psychology, Syracuse University, Syracuse, NY, USA.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Dolezal', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Brown', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Frasca', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA.'}, {'ForeName': 'Catherine Cruz', 'Initials': 'CC', 'LastName': 'Torres', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico, USA.'}, {'ForeName': 'Raynier', 'Initials': 'R', 'LastName': 'Crespo', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, School of Medicine, Center for Vulnerable Populations at Zuckerberg San Francisco General Hospital and Trauma Center, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Iribarren', 'Affiliation': 'School of Nursing, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Cheng-Shiun', 'Initials': 'CS', 'LastName': 'Leu', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Febo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Carballo-Diéguez', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02829-x']
314,32092321,"A Randomized, Double-Blind, Placebo-Controlled Study of Pulsed, Inhaled Nitric Oxide in Subjects at Risk of Pulmonary Hypertension Associated With Pulmonary Fibrosis.","BACKGROUND


The interstitial lung diseases include a variety of disorders, many of which are characterized by fibrotic changes (fILD). Of the fILDs, Idiopathic pulmonary fibrosis is the most common. Pulmonary hypertension (PH) frequently complicates fILD and is associated with impaired functional capability, lower physical activity, and significantly reduced life expectancy. There is no proven treatment for patients with fILD-PH. We report results from the first cohort of a phase 2b/3 trial with pulsed inhaled nitric oxide (iNO) in patients with fILD-PH.
METHODS


Subjects in cohort 1 were randomized to iNO 30 μg/kg ideal body weight/h (iNO30) or placebo for 8 weeks of blinded treatment; subjects then transitioned to open-label extension (OLE) on iNO30 followed by dose escalation to iNO45 then iNO75. Activity monitoring was used to assess changes in daily activity. Safety and efficacy were evaluated.
RESULTS


Twenty-three patients were randomized to iNO30 and 18 to placebo. During blinded treatment, iNO30 subjects showed an average improvement in moderate/vigorous physical activity (MVPA) and remained stable in overall activity. Placebo subjects showed an average drop of 26% in MVPA and a 12% drop in overall activity. The iNO group had an improvement in oxygen saturation. During OLE, subjects maintained their activity levels including placebo subjects who transitioned from a decline to a maintenance in all activity parameters. Inhaled nitric oxide at all doses (30, 45, and 75) was safe and well tolerated.
CONCLUSIONS


Treatment with iNO30 demonstrated clinically and statistically significant benefit in MVPA and clinically significant benefit in overall activity. In the OLE, higher doses of iNO were also safe and well tolerated while showing maintenance in activity parameters.",2020,During blinded treatment iNO30 subjects showed an average improvement in moderate/vigorous physical activity (MVPA) and remained stable in overall activity.,"['subjects at risk of Pulmonary Hypertension associated with Pulmonary Fibrosis (PH-PF) receiving Oxygen Therapy', 'patients with fILD-PH', 'patients with fILD-PH.\nMETHODS\n\n\nSubjects in Cohort 1']","['iNO 30 mcg/kg IBW/hr (iNO30) or placebo', 'placebo', 'pulsed, inhaled nitric oxide (iNO', 'pulsed iNO', 'Placebo']","['safety and efficacy', 'overall activity', 'activity levels', 'Safety and efficacy', 'oxygen saturation', 'safe and well tolerated', 'moderate/vigorous physical activity (MVPA']","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0034069', 'cui_str': 'Pulmonary Fibrosis'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1627892', 'cui_str': 'ng/g'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",23.0,0.139946,During blinded treatment iNO30 subjects showed an average improvement in moderate/vigorous physical activity (MVPA) and remained stable in overall activity.,"[{'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Nathan', 'Affiliation': 'Advanced Lung Disease and Transplant Program, Inova Heart and Vascular Institute, Inova Fairfax Hospital, Richmond, VA; Virginia Commonwealth University, Richmond, VA. Electronic address: steven.nathan@inova.org.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Flaherty', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Marilyn K', 'Initials': 'MK', 'LastName': 'Glassberg', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Raghu', 'Affiliation': 'the University of Arizona College of Medicine - Phoenix and Banner; University of Washington Medical Center, Seattle, WA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Swigris', 'Affiliation': 'Department of Medicine, National Jewish, Denver, CO.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Alvarez', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Ettinger', 'Affiliation': 'The Lung Research Center-Missouri, Chesterfield, MO.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Loyd', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fernandes', 'Affiliation': 'Bellerophon Therapeutics, Warren, NJ.'}, {'ForeName': 'Hunter', 'Initials': 'H', 'LastName': 'Gillies', 'Affiliation': 'Bellerophon Therapeutics, Warren, NJ.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Bellerophon Therapeutics, Warren, NJ.'}, {'ForeName': 'Parag', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Bellerophon Therapeutics, Warren, NJ.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Lancaster', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}]",Chest,['10.1016/j.chest.2020.02.016']
315,31822848,Effectiveness of the Genomics ADvISER decision aid for the selection of secondary findings from genomic sequencing: a randomized clinical trial.,"PURPOSE


To evaluate the effectiveness of the Genomics ADvISER (www.genomicsadviser.com) decision aid (DA) for selection of secondary findings (SF), compared with genetic counseling alone.
METHODS


A randomized controlled trial (RCT) was conducted to evaluate whether the Genomics ADvISER is superior to genetic counseling when hypothetically selecting SF. Participants were randomized to use the DA followed by discussion with a genetic counselor, or to genetic counseling alone. Surveys were administered at baseline and post-intervention. Primary outcome was decisional conflict. Secondary outcomes were knowledge, preparation for, and satisfaction with decision-making, anxiety, and length of counseling session.
RESULTS


Participants (n = 133) were predominantly White/European (74%), female (90%), and ≥50 years old (60%). Decisional conflict (mean difference 0.05; P = 0.60), preparation for decision-making (0.17; P = 0.95), satisfaction with decision (-2.18; P = 0.06), anxiety (0.72; P = 0.56), and knowledge of sequencing limitations (0.14; P = 0.70) did not significantly differ between groups. However, intervention participants had significantly higher knowledge of SF (0.39; P < 0.001) and sequencing benefits (0.97; P = 0.01), and significantly shorter counseling time (24.40 minutes less; P < 0.001) CONCLUSIONS: The Genomics ADvISER did not decrease decisional conflict but reduced counseling time and improved knowledge. This decision aid could serve as an educational tool, reducing in-clinic time and potentially health care costs.",2020,"However, intervention participants had significantly higher knowledge of SF (0.39; P < 0.001) and sequencing benefits (0.97; P = 0.01), and significantly shorter counseling time (24.40 minutes less; P < 0.001)","['Participants (n\u2009=\u2009133) were predominantly White/European (74%), female (90%), and ≥50 years old (60']","['Genomics ADvISER (www.genomicsadviser.com) decision aid (DA', 'DA followed by discussion with a genetic counselor, or to genetic counseling alone', 'genetic counseling alone']","['knowledge, preparation for, and satisfaction with decision-making, anxiety, and length of counseling session', 'counseling time and improved knowledge', 'knowledge of sequencing limitations', 'knowledge of SF', 'shorter counseling time', 'anxiety', 'Decisional conflict', 'decisional conflict']","[{'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0887950', 'cui_str': 'Genomics'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0587719', 'cui_str': 'Genetic counselor'}, {'cui': 'C0017382', 'cui_str': 'Genetic counseling'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}]",133.0,0.134204,"However, intervention participants had significantly higher knowledge of SF (0.39; P < 0.001) and sequencing benefits (0.97; P = 0.01), and significantly shorter counseling time (24.40 minutes less; P < 0.001)","[{'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Bombard', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada. yvonne.bombard@utoronto.ca.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Clausen', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Shickh', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Mighton', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Selina', 'Initials': 'S', 'LastName': 'Casalino', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Theresa H M', 'Initials': 'THM', 'LastName': 'Kim', 'Affiliation': 'The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Muir', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Carlsson', 'Affiliation': 'University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Baxter', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Adena', 'Initials': 'A', 'LastName': 'Scheer', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Elser', 'Affiliation': 'University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Eisen', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Panchal', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Graham', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Melyssa', 'Initials': 'M', 'LastName': 'Aronson', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Piccinin', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Talia', 'Initials': 'T', 'LastName': 'Mancuso', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Semotiuk', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'June C', 'Initials': 'JC', 'LastName': 'Carroll', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Offit', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Robson', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jada G', 'Initials': 'JG', 'LastName': 'Hamilton', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Glogowski', 'Affiliation': 'GeneDx, Gaithersburg, MD, USA.'}, {'ForeName': 'Kasmintan', 'Initials': 'K', 'LastName': 'Schrader', 'Affiliation': 'Department of Molecular Oncology and Hereditary Cancer Program, BC Cancer Agency, Vancouver, BC, Canada.'}, {'ForeName': 'Raymond H', 'Initials': 'RH', 'LastName': 'Kim', 'Affiliation': 'The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Lerner-Ellis', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Laupacis', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-019-0702-z']
316,32237024,"Antenatal magnesium sulphate for the prevention of cerebral palsy in infants born preterm: a double-blind, randomised, placebo-controlled, multi-centre trial.","OBJECTIVE


To study the effect of antenatal magnesium sulphate (MgSO 4  ) on cerebral palsy (CP) in a manner that also provides adequate power for a linked trial sequential analysis.
DESIGN


Double-blind, randomised, placebo-controlled, multi-centre trial.
SETTING


Fourteen Danish obstetric departments.
POPULATION


In total, 560 pregnant women at risk for preterm delivery before 32 weeks of gestation were randomised from December 2011 to January 2018. Those women gave birth to 680 children.
METHODS


Women were randomised to receive either a loading dose of 5 g MgSO 4  followed by 1 g/hour or a placebo in identical volumes. The children were followed up at a corrected age of 18 months or older with a review of their medical charts and with the Ages and Stages Questionnaire.
MAIN OUTCOME MEASURE


The primary outcome measure was moderate to severe CP. Secondary outcomes included mortality, neonatal morbidity, blindness and mild CP.
RESULTS


The crude rates of moderate to severe CP in the MgSO 4  group and the placebo group were 2.0% and 3.3%, respectively. The adjusted odds of moderate to severe CP were lower in the MgSO 4  group than in the placebo group (odds ratio 0.61; 95% CI 0.23-1.65).
CONCLUSIONS


Antenatal MgSO 4  before 32 weeks of gestation decreases the likelihood of moderate to severe CP; these results are entirely consistent with other randomised evidence summarised in the linked trial sequential analysis.
TWEETABLE ABSTRACT


Antenatal magnesium sulphate may decrease the risk of moderate to severe cerebral palsy in children born before 32 weeks of gestation.",2020,"The adjusted odds of moderate to severe CP were lower in the MgSO 4  group than in the placebo group (odds ratio 0.61; 95% confidence interval 0.23-1.65).
","['Women', 'Those women gave birth to 680 children', '560 pregnant women at risk for preterm delivery before 32 weeks of gestation were randomised from December 2011 to January 2018', 'children were followed up at a corrected age of 18 months or older with a review of their medical charts and with the Ages and Stages Questionnaire', 'infants born preterm', 'Fourteen Danish obstetric departments']","['antenatal magnesium sulphate (MgSO 4  ', 'placebo', 'Antenatal magnesium sulphate']","['crude rates of moderate to severe CP', 'cerebral palsy (CP', 'cerebral palsy', 'adjusted odds of moderate to severe CP', 'moderate to severe CP', 'mortality, neonatal morbidity, blindness, and mild CP']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0699752', 'cui_str': 'Review of'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0028775', 'cui_str': 'Obstetrics department'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]",560.0,0.7697,"The adjusted odds of moderate to severe CP were lower in the MgSO 4  group than in the placebo group (odds ratio 0.61; 95% confidence interval 0.23-1.65).
","[{'ForeName': 'H T', 'Initials': 'HT', 'LastName': 'Wolf', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Brok', 'Affiliation': 'Department of Paediatric and Adolescent Medicine, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'T B', 'Initials': 'TB', 'LastName': 'Henriksen', 'Affiliation': 'Department of Paediatrics (Intensive Care Neonatology), Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Greisen', 'Affiliation': 'Department of Neonatology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Salvig', 'Affiliation': 'Department of Obstetrics and Gynecology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Pryds', 'Affiliation': 'Department of Paediatrics, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hedegaard', 'Affiliation': 'Klinik Hedegaard, Copenhagen, Denmark.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Weber', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'H K', 'Initials': 'HK', 'LastName': 'Hegaard', 'Affiliation': 'Department of Obstetrics and Gynaecology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pinborg', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'L D', 'Initials': 'LD', 'LastName': 'Huusom', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16239']
317,32235339,"Efficacy of  Panax ginseng  Meyer Herbal Preparation HRG80 in Preventing and Mitigating Stress-Induced Failure of Cognitive Functions in Healthy Subjects: A Pilot, Randomized, Double-Blind, Placebo-Controlled Crossover Trial.","BACKGROUND


The aim of this pilot study was to compare the efficacy of hydroponically cultivated red  Panax ginseng  Meyer root preparation (HRG80) and traditionally harvested six-year-old white  P. ginseng  standard preparation (PGS) with placebo in preventing symptoms of stress.
METHODS


The effects of HRG80, PGS, and placebo capsules were studied in 50 tired healthy subjects in a three-arm, randomized, double-blinded, placebo-controlled crossover trial. Efficacy-outcome measures included the accuracy of processing the d2 test for cognitive functions, obtained accuracy score in a computerized memory test, and the perceived-stress (PS) score.
RESULTS


A statistically significant interaction effect between time and treatment ( p  < 0.0001) was observed in the attention d2 and memory tests, indicating that HRG80 treatment was more beneficial than that with a placebo. The effects of PGS were better than those of the placebo, but the difference was not statistically significant. There was significant difference between the effects of HRG80 and PGS ( p  < 0.0001) that were observed after single (Day 1) and repeated administrations on Days 5 and 12 of treatment.
CONCLUSION


Overall, HRG80 treatment was significantly superior compared to that with the PGS and placebo regarding attention, memory, and PS scores after single and repeated administrations for 5 and 12 days.",2020,"Overall, HRG80 treatment was significantly superior compared to that with the PGS and placebo regarding attention, memory, and PS scores after single and repeated administrations for 5 and 12 days.","['50 tired healthy subjects', 'Healthy Subjects']","['placebo', 'HRG80, PGS, and placebo', 'Placebo', 'hydroponically cultivated red  Panax ginseng  Meyer root preparation (HRG80) and traditionally harvested six-year-old white  P. ginseng  standard preparation (PGS) with placebo', 'Panax ginseng  Meyer Herbal Preparation HRG80']","['accuracy of processing the d2 test for cognitive functions, obtained accuracy score in a computerized memory test, and the perceived-stress (PS) score', 'HRG80 and PGS', 'attention, memory, and PS scores']","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031619', 'cui_str': 'Glycerol Phosphoglycerides'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0086767', 'cui_str': 'Ginseng'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0038135', 'cui_str': 'Preparations, Standard'}, {'cui': 'C0949854', 'cui_str': 'Plant Preparation'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0031619', 'cui_str': 'Glycerol Phosphoglycerides'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",50.0,0.595532,"Overall, HRG80 treatment was significantly superior compared to that with the PGS and placebo regarding attention, memory, and PS scores after single and repeated administrations for 5 and 12 days.","[{'ForeName': 'Pierre-Antoine', 'Initials': 'PA', 'LastName': 'Mariage', 'Affiliation': 'Botalys SA, 8 quai des usines, 7800 Ath, Belgium.'}, {'ForeName': 'Areg', 'Initials': 'A', 'LastName': 'Hovhannisyan', 'Affiliation': 'Sport Medicine and Antidoping Service Republican Centre, Yerevan 0001, Armenia.'}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Panossian', 'Affiliation': 'Phytomed AB, Bofinkvagen 1, Vaxtorp 31275, Sweden.'}]","Pharmaceuticals (Basel, Switzerland)",['10.3390/ph13040057']
318,32223762,Using motivational interviewing to reduce parental risk related behaviors for early childhood caries: a pilot study.,"BACKGROUND


Decades of epidemiological studies have documented high rates of early childhood caries (ECC) among American Indian and Alaska Native (AIAN) children. The aim of this pilot study was to investigate if a motivational interviewing (MI) intervention improved oral self-care behaviors of AIAN caregivers of infants, and determine if the MI intervention promoted positive changes in caregivers' ECC risk-related behaviors.
METHODS


Caregivers of infants presenting for well- child visits in a medical clinic were randomized to treatment and control groups. At the first visit, a caries risk test (CRT) for cariogenic bacteria was completed for both groups. The Parental Care of Child's Teeth (PCCT) was administered at the second visit and used to assess ECC risk-related behaviors. Over the course of four well-child visits, caregivers in the treatment group participated in a MI discussion focusing on behavior changes and desired outcomes for their personal oral health and their child's. The duration of the intervention was 1 year. The control group was given oral health information traditionally provided at well-child visits. At the fourth well-child visit, the CRT and PCCT questionnaire were administered again.
RESULTS


The mean bacterial load for mutans streptococcus (MS) was similar at both visits. A slight reduction in the mean bacterial levels of lactobacilli was observed in both the test and control groups after the last visit, although not at a level of statistical significance. The treatment group showed minimal improvement in child feeding practices and nighttime bottle habits.
CONCLUSIONS


Motivational Interviewing had little effect on oral self-care behaviors as measured by bacterial load, nor did MI reduce parental risk related behavior for early childhood caries.
TRIAL REGISTRATION


Clinicaltrials.gov# NCT04286256. Retrospectively registered, February 26, 2020.",2020,"A slight reduction in the mean bacterial levels of lactobacilli was observed in both the test and control groups after the last visit, although not at a level of statistical significance.","['Caregivers of infants presenting for well- child visits in a medical clinic', 'early childhood caries', 'American Indian and Alaska Native (AIAN) children', ""caregivers' ECC risk-related behaviors""]","['MI intervention', 'motivational interviewing (MI) intervention', 'motivational interviewing', 'Motivational Interviewing']","['mean bacterial load for mutans streptococcus (MS', 'child feeding practices and nighttime bottle habits', 'mean bacterial levels of lactobacilli', 'oral self-care behaviors']","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1444717', 'cui_str': 'Well child visit'}, {'cui': 'C0338037', 'cui_str': ""Private physicians' group office (environment)""}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}, {'cui': 'C0002460', 'cui_str': 'American Indians'}, {'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4077283', 'cui_str': '(67Ga)ECC'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2936404', 'cui_str': 'Bacterial Load'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319838', 'cui_str': 'Bottle'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}]",,0.0296306,"A slight reduction in the mean bacterial levels of lactobacilli was observed in both the test and control groups after the last visit, although not at a level of statistical significance.","[{'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Blue', 'Affiliation': 'Division of Dental Hygiene, University of Minnesota, 515 Delaware Street SE, 9-372 Moos Tower, Minneapolis, MN, 55455, USA. bluex005@umn.edu.'}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Arnett', 'Affiliation': 'Division of Dental Hygiene, University of Minnesota, 420 Delaware St SE, MMC 729, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Hiwet', 'Initials': 'H', 'LastName': 'Ephrem', 'Affiliation': 'Division of Dental Hygiene, University of Minnesota, 515 Delaware Street SE, 9-372 Moos Tower, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Lunos', 'Affiliation': 'University of Minnesota, 717 Delaware Street SE, 140-27, Minneapolis, MN, 55414, USA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ruoqiong', 'Affiliation': 'Department of Diagnostic and Biological Sciences, University of Minnesota, 515 Delaware Street SE, 17-237 Moos Tower, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Division of Pediatric Dentistry, University of Minnesota, 515 Delaware Street SE, 6-150 Moos Tower, Minneapolis, MN, 55455, USA.'}]",BMC oral health,['10.1186/s12903-020-1052-6']
319,32232608,Retinal Image Slip Must Pass the Threshold for Human Vestibulo-Ocular Reflex Adaptation.,"We sought to determine whether repeated vestibulo-ocular reflex (VOR) adaptation training to increase the VOR gain (eye/head velocity) had a lasting effect in normal subjects and whether there was a retinal image slip tolerance threshold for VOR adaptation. We used the unilateral incremental VOR adaptation technique and horizontal active (self-generated, predictable) head impulses as the vestibular stimulus. Both active and passive (imposed, unpredictable) head impulse VOR gains were measured before and after unilateral incremental VOR adaptation training. The adapting side was pseudo-randomized for left or right. We tested ten normal subjects over one block (10 sessions over 12 days) of VOR adaptation training and testing, immediately followed by a second block (5 sessions over 19 days) of testing only without training. Our findings show robust short-term VOR adaptation of ~ 10 % immediately after each 15-min training session, but that the daily pre-adaptation gain was most different on days 1 and 2, and for subsequent training days before saturating to ~ 5 % greater than the pre-adaptation gain on day 1. This increase was partially retained for 19 days after regular training stopped. The data suggest that stable vision in normal subjects is maintained when there is < 5 % deviation in VOR gain from the original baseline, which corresponds to < 9°/s retinal image slip. Below this threshold, there is poor adaptive drive to return the gain to its original baseline value.",2020,"Both active and passive (imposed, unpredictable) head impulse VOR gains were measured before and after unilateral incremental VOR adaptation training.",['normal subjects'],"['VOR adaptation training and testing, immediately followed by a second block (5 sessions over 19\xa0days) of testing only without training', 'unilateral incremental VOR adaptation technique and horizontal active (self-generated, predictable) head impulses as the vestibular stimulus', 'repeated vestibulo-ocular reflex (VOR) adaptation training']","['VOR gain (eye/head velocity', 'VOR gain']","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]","[{'cui': 'C0034944', 'cui_str': 'Reflexes, Vestibo-Ocular'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0443235', 'cui_str': 'Impulse (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}]","[{'cui': 'C0034944', 'cui_str': 'Reflexes, Vestibo-Ocular'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}]",10.0,0.022205,"Both active and passive (imposed, unpredictable) head impulse VOR gains were measured before and after unilateral incremental VOR adaptation training.","[{'ForeName': 'M Muntaseer', 'Initials': 'MM', 'LastName': 'Mahfuz', 'Affiliation': 'Balance and Vision Laboratory, Neuroscience Research Australia, Cnr Barker Street & Easy Street Randwick, Sydney, NSW, 2031, Australia.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Schubert', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Laboratory of Vestibular NeuroAdaptation, Johns Hopkins University, Baltimore, MD, 21205, USA.'}, {'ForeName': 'William V C', 'Initials': 'WVC', 'LastName': 'Figtree', 'Affiliation': 'Balance and Vision Laboratory, Neuroscience Research Australia, Cnr Barker Street & Easy Street Randwick, Sydney, NSW, 2031, Australia.'}, {'ForeName': 'Americo A', 'Initials': 'AA', 'LastName': 'Migliaccio', 'Affiliation': 'Balance and Vision Laboratory, Neuroscience Research Australia, Cnr Barker Street & Easy Street Randwick, Sydney, NSW, 2031, Australia. a.migliaccio@neura.edu.au.'}]",Journal of the Association for Research in Otolaryngology : JARO,['10.1007/s10162-020-00751-6']
320,30664661,Psychiatric adverse events and effects on mood with prolonged-release naltrexone/bupropion combination therapy: a pooled analysis.,"BACKGROUND/OBJECTIVES


Prolonged-release (PR) naltrexone 32 mg/bupropion 360 mg (NB) is approved for chronic weight management as an adjunct to reduced-calorie diet and increased physical activity. Central nervous system-active medications have the potential to affect mood; therefore, post hoc analysis of clinical trial data was conducted to evaluate psychiatric adverse events (PAEs) and effects on mood of NB therapy versus placebo.
SUBJECTS/METHODS


Data were pooled from 5 prospective, double-blind, randomized, placebo-controlled clinical trials (duration range, 24-56 weeks) of NB in subjects with overweight or obesity. PAEs were collected via AE preferred terms, organized into major subtopics (e.g., anxiety, depression, sleep disorders), and divided into category terms (e.g., anxiety, potential anxiety symptoms). Additionally, the Inventory of Depressive Symptomatology Self Report (IDS-SR; score range 0-84) and the Columbia Classification Algorithm of Suicide Assessment (C-CASA) evaluated treatment-emergent depressive/anxiety symptoms and suicidal behavior/ideation, respectively.
RESULTS


Baseline characteristics and comorbidities were comparable for placebo (n = 1515) and NB (n = 2545). Most common PAEs in the NB group (using category grouping; NB vs placebo) were sleep disorders (12.7 vs 7.9%, P < 0.001), anxiety (5.4 vs 3.3%, P = 0.029), and depression (1.8 vs 2.7%, P = 0.014); PAEs were more frequent during dose escalation and generally mild or moderate. Mean (SD) changes in IDS-SR total score from baseline to endpoint were small in both groups: 0.13 (5.83) for NB and -0.45 (5.65) for placebo. Retrospective AE categorization via C-CASA confirmed no completed suicides, suicide attempts, or preparatory acts toward imminent suicidal behavior.
CONCLUSIONS


This large pooled analysis of 5 clinical trials provides additional safety information about the NB PAE profile. Anxiety and sleep disorder-related PAEs were more frequent with NB versus placebo but were mostly mild to moderate and generally occurred early. Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.",2019,"Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.",['subjects with overweight or obesity'],"['naltrexone/bupropion combination therapy', 'bupropion 360\u2009mg (NB', 'placebo']","['Depression-related PAEs', 'depression', 'suicidal ideation or behavior', 'Inventory of Depressive Symptomatology Self Report (IDS-SR; score range 0-84) and the Columbia Classification Algorithm of Suicide Assessment (C-CASA) evaluated treatment-emergent depressive/anxiety symptoms and suicidal behavior/ideation, respectively', 'Psychiatric adverse events', 'Mean (SD) changes in IDS-SR total score', 'Anxiety and sleep disorder-related PAEs', 'anxiety', 'sleep disorders']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0002045'}, {'cui': 'C3494753', 'cui_str': 'Suicide evaluation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior (finding)'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}]",,0.497082,"Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Apovian', 'Affiliation': 'Boston University School of Medicine and Department of Medicine Section of Endocrinology, Diabetes and Nutrition, Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'McElroy', 'Affiliation': 'Lindner Center of HOPE, Mason, and Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Dunayevich', 'Affiliation': 'Annexon Biosciences, South San Francisco, CA, USA.'}, {'ForeName': 'Lisette M', 'Initials': 'LM', 'LastName': 'Acevedo', 'Affiliation': 'Nalpropion Pharmaceuticals, Inc, La Jolla, CA, USA.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Greenway', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA. frank.greenway@pbrc.edu.'}]",International journal of obesity (2005),['10.1038/s41366-018-0302-z']
321,32234700,Efficacy of a Theory-Based Cognitive Behavioral Technique App-Based Intervention for Patients With Insomnia: Randomized Controlled Trial.,"BACKGROUND


Sleep hygiene is important for maintaining good sleep and reducing insomnia.
OBJECTIVE


This study examined the long-term efficacy of a theory-based app (including cognitive behavioral therapy [CBT], theory of planned behavior [TPB], health action process approach [HAPA], and control theory [CT]) on sleep hygiene among insomnia patients.
METHODS


The study was a 2-arm single-blind parallel-group randomized controlled trial (RCT). Insomnia patients were randomly assigned to a treatment group that used an app for 6 weeks (ie, CBT for insomnia [CBT-I], n=156) or a control group that received only patient education (PE, n=156) through the app. Outcomes were assessed at baseline and 1 month, 3 months, and 6 months postintervention. Primary outcomes were sleep hygiene, insomnia, and sleep quality. Secondary outcomes included attitudes toward sleep hygiene behavior, perceived behavioral control, behavioral intention, action and coping planning, self-monitoring, behavioral automaticity, and anxiety and depression. Linear mixed models were used to evaluate the magnitude of changes in outcomes between the two groups and across time.
RESULTS


Sleep hygiene was improved in the CBT-I group compared with the PE group (P=.02 at 1 month, P=.04 at 3 months, and P=.02 at 6 months) as were sleep quality and severity of insomnia. Mediation analyses suggested that perceived behavioral control on sleep hygiene as specified by TPB along with self-regulatory processes from HAPA and CT mediated the effect of the intervention on outcomes.
CONCLUSIONS


Health care providers might consider using a CBT-I app to improve sleep among insomnia patients.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03605732; https://clinicaltrials.gov/ct2/show/NCT03605732.",2020,"RESULTS


Sleep hygiene was improved in the CBT-I group compared with the PE group (P=.02 at 1 month, P=.04 at 3 months, and P=.02 at 6 months) as were sleep quality and severity of insomnia.","['insomnia patients', 'Insomnia patients', 'Patients With Insomnia']","['theory-based app (including cognitive behavioral therapy [CBT', 'Theory-Based Cognitive Behavioral Technique App-Based Intervention', 'control theory [CT', 'control group that received only patient education (PE, n=156) through the app']","['sleep quality and severity of insomnia', 'sleep hygiene', 'attitudes toward sleep hygiene behavior, perceived behavioral control, behavioral intention, action and coping planning, self-monitoring, behavioral automaticity, and anxiety and depression', 'Sleep hygiene', 'sleep hygiene, insomnia, and sleep quality']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",156.0,0.0873581,"RESULTS


Sleep hygiene was improved in the CBT-I group compared with the PE group (P=.02 at 1 month, P=.04 at 3 months, and P=.02 at 6 months) as were sleep quality and severity of insomnia.","[{'ForeName': 'Nilofar', 'Initials': 'N', 'LastName': 'Rajabi Majd', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Broström', 'Affiliation': 'Department of Nursing, School of Health and Welfare, Jönköping University, Jönköping, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ulander', 'Affiliation': 'Department of Clinical Neurophysiology, Linköping University Hospital, Linköping, Sweden.'}, {'ForeName': 'Chung-Ying', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Department of Rehabilitation Sciences, Hong Kong Polytechnic University, Hung Hom, China (Hong Kong).'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Griffiths', 'Affiliation': 'International Gaming Research Unit, Psychology Department, Nottingham Trent University, Nottingham, United Kingdom.'}, {'ForeName': 'Vida', 'Initials': 'V', 'LastName': 'Imani', 'Affiliation': 'Pediatric Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Daniel Kwasi', 'Initials': 'DK', 'LastName': 'Ahorsu', 'Affiliation': 'Department of Rehabilitation Sciences, Hong Kong Polytechnic University, Hung Hom, China (Hong Kong).'}, {'ForeName': 'Maurice M', 'Initials': 'MM', 'LastName': 'Ohayon', 'Affiliation': 'Division of Public Mental Health and Population Sciences, Stanford Sleep Epidemiology Research Center, Stanford University, Palo Alto, CA, United States.'}, {'ForeName': 'Amir H', 'Initials': 'AH', 'LastName': 'Pakpour', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran.'}]",Journal of medical Internet research,['10.2196/15841']
322,32234702,Forecasting Mood in Bipolar Disorder From Smartphone Self-assessments: Hierarchical Bayesian Approach.,"BACKGROUND


Bipolar disorder is a prevalent mental health condition that is imposing significant burden on society. Accurate forecasting of symptom scores can be used to improve disease monitoring, enable early intervention, and eventually help prevent costly hospitalizations. Although several studies have examined the use of smartphone data to detect mood, only few studies deal with forecasting mood for one or more days.
OBJECTIVE


This study aimed to examine the feasibility of forecasting daily subjective mood scores based on daily self-assessments collected from patients with bipolar disorder via a smartphone-based system in a randomized clinical trial.
METHODS


We applied hierarchical Bayesian regression models, a multi-task learning method, to account for individual differences and forecast mood for up to seven days based on 15,975 smartphone self-assessments from 84 patients with bipolar disorder participating in a randomized clinical trial. We reported the results of two time-series cross-validation 1-day forecast experiments corresponding to two different real-world scenarios and compared the outcomes with commonly used baseline methods. We then applied the best model to evaluate a 7-day forecast.
RESULTS


The best performing model used a history of 4 days of self-assessment to predict future mood scores with historical mood being the most important predictor variable. The proposed hierarchical Bayesian regression model outperformed pooled and separate models in a 1-day forecast time-series cross-validation experiment and achieved the predicted metrics, R 2 =0.51 and root mean squared error of 0.32, for mood scores on a scale of -3 to 3. When increasing the forecast horizon, forecast errors also increased and the forecast regressed toward the mean of data distribution.
CONCLUSIONS


Our proposed method can forecast mood for several days with low error compared with common baseline methods. The applicability of a mood forecast in the clinical treatment of bipolar disorder has also been discussed.",2020,"Accurate forecasting of symptom scores can be used to improve disease monitoring, enable early intervention, and eventually help prevent costly hospitalizations.","['84 patients with bipolar disorder participating in a randomized clinical trial', 'patients with bipolar disorder via a smartphone-based system in a randomized clinical trial']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",[],[],84.0,0.0733923,"Accurate forecasting of symptom scores can be used to improve disease monitoring, enable early intervention, and eventually help prevent costly hospitalizations.","[{'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Busk', 'Affiliation': 'Department of Applied Mathematics and Computer Science, Technical University of Denmark, Lyngby, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Faurholt-Jepsen', 'Affiliation': 'Copenhagen Affective Disorder Research Center, Psychiatric Center Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Frost', 'Affiliation': 'Monsenso ApS, Copenhagen, Denmark.'}, {'ForeName': 'Jakob E', 'Initials': 'JE', 'LastName': 'Bardram', 'Affiliation': 'Department of Health Technology, Technical University of Denmark, Lyngby, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Vedel Kessing', 'Affiliation': 'Copenhagen Affective Disorder Research Center, Psychiatric Center Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Winther', 'Affiliation': 'Department of Applied Mathematics and Computer Science, Technical University of Denmark, Lyngby, Denmark.'}]",JMIR mHealth and uHealth,['10.2196/15028']
323,32232692,"Prophylactic efficacy of ninjin'yoeito for oxaliplatin-induced cumulative peripheral neuropathy in patients with colorectal cancer receiving postoperative adjuvant chemotherapy: a randomized, open-label, phase 2 trial (HOPE-2).","PURPOSE


Peripheral neuropathy (PN) is an intractable side effect of oxaliplatin, with no effective prophylaxis so far. Ninjin'yoeito (NYT), a Kampo medicine, is protective against oxaliplatin-induced neuronal cell injury in vitro and ameliorates oxaliplatin-induced PN in vivo. Thus, this randomized controlled trial was aimed at clarifying NYT's prophylactic effect for oxaliplatin-induced cumulative PN.
METHODS


52 patients with colorectal cancers of pathological stage 3 received postoperative adjuvant chemotherapy with the CapeOX regimen: eight cycles of capecitabine (2400 mg/m 2 ) plus oxaliplatin (130 mg/m 2 ) at 3-week intervals. They were randomly assigned to NYT administration and non-administration groups. NYT (9.0 g/day) was administered from day 1 of cycle 1 in the NYT group. The NYT was administered orally daily throughout each cycle. The primary endpoint was the grade of cumulative PN at the end of eight cycles. The secondary endpoints included relative dose intensity (RDI) of oxaliplatin, recurrence-free survival (RFS), and overall survival (OS).
RESULTS


40 patients (n = 20 in both groups) completed 8 chemotherapy cycles. The incidence of grade 2 or greater cumulative PN at the 8th chemotherapy cycle was significantly lower in the NYT group (2/20, 10.0%) than in the control group (11/20, 55.0%, P < 0.01). RDI of oxaliplatin was significantly higher in the NYT group than in the control group (P = 0.02). RFS and OS were better in the NYT group than in the control group, but the difference was not significant.
CONCLUSIONS


NYT may reduce the incidence of oxaliplatin-induced cumulative PN and facilitate maintenance of the CapeOX dosing regimen.",2020,"RFS and OS were better in the NYT group than in the control group, but the difference was not significant.
","['52 patients with colorectal cancers of pathological stage 3 received postoperative adjuvant chemotherapy with the CapeOX regimen: eight cycles of', '40 patients (n\u2009=\u200920 in both groups) completed 8 chemotherapy cycles', 'patients with colorectal cancer receiving postoperative adjuvant chemotherapy']","[""ninjin'yoeito for oxaliplatin"", 'oxaliplatin', 'capecitabine (2400\xa0mg/m 2 ) plus oxaliplatin']","['RFS and OS', 'relative dose intensity (RDI) of oxaliplatin, recurrence-free survival (RFS), and overall survival (OS', 'RDI of oxaliplatin', 'incidence of grade 2 or greater cumulative PN', 'grade of cumulative PN']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1302181', 'cui_str': 'Chemotherapy cycle (procedure)'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C4517656', 'cui_str': 'Two thousand four hundred'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",52.0,0.207819,"RFS and OS were better in the NYT group than in the control group, but the difference was not significant.
","[{'ForeName': 'Yoshiharu', 'Initials': 'Y', 'LastName': 'Motoo', 'Affiliation': 'Department of Medical Oncology, Kanazawa Medical University, 1-1 Daigaku, Uchinada, Ishikawa, 920-0293, Japan. motoo@kanazawa-med.ac.jp.'}, {'ForeName': 'Yasuto', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Department of General and Gastroenterological Surgery, Kanazawa Medical University, 1-1 Daigaku, Uchinada, Ishikawa, 920-0293, Japan.'}, {'ForeName': 'Hideto', 'Initials': 'H', 'LastName': 'Fujita', 'Affiliation': 'Department of General and Gastroenterological Surgery, Kanazawa Medical University, 1-1 Daigaku, Uchinada, Ishikawa, 920-0293, Japan.'}]",International journal of clinical oncology,['10.1007/s10147-020-01648-3']
324,31872340,Sequential Introduction of Exercise First Followed by Nutrition Improves Program Adherence During Pregnancy: a Randomized Controlled Trial.,"BACKGROUND


Adhering to nutrition and exercise recommendations simultaneously during pregnancy may be challenging. The purpose was to examine adherence to the sequential introduction of nutrition and exercise behaviors during pregnancy in comparison with a simultaneous approach.
METHOD


A randomized controlled trial including nutrition and exercise was executed. Using a stratified body mass index (BMI) randomization, participants (n = 88) were allocated to one of three groups at 12-18 weeks gestation. Group A received nutrition and exercise simultaneously. Group B received nutrition first and Group C received exercise first, and the second behavior was added at 25 weeks gestation for both groups. The program included weekly weighing, supervised walking sessions, and/or nutrition counseling. Adherence (primary outcome) was measured by scoring women on meeting the intervention goals (3 nutrition and 3 exercise goals) and converted to a percentage. Secondary health outcomes were gestational weight gain (GWG) and excessive GWG on the program, birthweight, macrosomia (birthweight > 4000 g), and low birthweight (birthweight < 2500 g).
RESULTS


Group C (n = 23) had the highest adherence to the program (80.2 ± 14.7%) compared with Groups A (n = 17; 60.9 ± 17.9%) and B (n = 20; 66.8 ± 16.7%; p < 0.05, η p 2  = 0.26). There was a significant effect for gestational weight gain (p < 0.05; η p 2  = 0.10) as Group C gained less weight (7.7 ± 2.2 kg) over Group B (9.8 ± 2.8 kg; p = 0.04), however, not Group A (9.1 ± 3.5, p = 0.35). Non-significant small effects favored Group C for the prevention of EGWG (Cramer's V = 0.13).
CONCLUSION


Introducing exercise first followed by nutrition at 25 weeks gestation can improve adherence to multiple behavior change programs and thus have a positive effect on health outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02804061.",2020,"There was a significant effect for gestational weight gain (p < 0.05; η p 2  = 0.10) as Group C gained less weight (7.7 ± 2.2 kg) over Group B (9.8 ± 2.8 kg; p = 0.04), however, not Group A (9.1 ± 3.5, p = 0.35).","['4000\xa0g), and low birthweight (birthweight <\u20092500\xa0g']","['nutrition and exercise', 'Exercise', 'nutrition and exercise simultaneously', 'weighing, supervised walking sessions, and/or nutrition counseling']","['gestational weight gain', 'gestational weight gain (GWG) and excessive GWG on the program, birthweight, macrosomia ', 'Program Adherence', 'birthweight ']","[{'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4319601', 'cui_str': '2500 (qualifier value)'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3714365', 'cui_str': 'Counseling about nutrition'}]","[{'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0158915', 'cui_str': 'Birth weight 4500 grams OR more'}]",,0.127356,"There was a significant effect for gestational weight gain (p < 0.05; η p 2  = 0.10) as Group C gained less weight (7.7 ± 2.2 kg) over Group B (9.8 ± 2.8 kg; p = 0.04), however, not Group A (9.1 ± 3.5, p = 0.35).","[{'ForeName': 'Taniya S', 'Initials': 'TS', 'LastName': 'Nagpal', 'Affiliation': 'R. Samuel McLaughlin Foundation-Exercise and Pregnancy Laboratory, University of Western Ontario, 2245, 3-M Centre, London, Ontario, N6A 3K7, Canada.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Prapavessis', 'Affiliation': 'School of Kinesiology, Faculty of Health Sciences, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Christina G', 'Initials': 'CG', 'LastName': 'Campbell', 'Affiliation': 'Department of Food Science and Human Nutrition, Iowa State University, Ames, IA, USA.'}, {'ForeName': 'Barbra', 'Initials': 'B', 'LastName': 'de Vrijer', 'Affiliation': ""Children's Health Research Institute, University of Western Ontario, London, Ontario, Canada.""}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Bgeginski', 'Affiliation': 'R. Samuel McLaughlin Foundation-Exercise and Pregnancy Laboratory, University of Western Ontario, 2245, 3-M Centre, London, Ontario, N6A 3K7, Canada.'}, {'ForeName': 'Karishma', 'Initials': 'K', 'LastName': 'Hosein', 'Affiliation': 'R. Samuel McLaughlin Foundation-Exercise and Pregnancy Laboratory, University of Western Ontario, 2245, 3-M Centre, London, Ontario, N6A 3K7, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Paplinskie', 'Affiliation': 'R. Samuel McLaughlin Foundation-Exercise and Pregnancy Laboratory, University of Western Ontario, 2245, 3-M Centre, London, Ontario, N6A 3K7, Canada.'}, {'ForeName': 'Mollie', 'Initials': 'M', 'LastName': 'Manley', 'Affiliation': 'R. Samuel McLaughlin Foundation-Exercise and Pregnancy Laboratory, University of Western Ontario, 2245, 3-M Centre, London, Ontario, N6A 3K7, Canada.'}, {'ForeName': 'Michelle F', 'Initials': 'MF', 'LastName': 'Mottola', 'Affiliation': 'R. Samuel McLaughlin Foundation-Exercise and Pregnancy Laboratory, University of Western Ontario, 2245, 3-M Centre, London, Ontario, N6A 3K7, Canada. mmottola@uwo.ca.'}]",International journal of behavioral medicine,['10.1007/s12529-019-09840-0']
325,32229186,Ten-year disease progression and mortality rates in men who experience biochemical recurrence versus persistence after radical prostatectomy and undergo salvage radiation therapy: A post-hoc analysis of RTOG 9601 trial data.,"PURPOSE


To compare local/metastatic disease progression and overall mortality rates in men with node-negative prostate cancer at radical prostatectomy (RP) that experience biochemical recurrence vs. persistence postoperatively and undergo salvage radiation therapy (sRT).
MATERIALS AND METHODS


Data on 760 men who participated in the RTOG 9601 trial were extracted using the NCTN data archive platform. Patients were stratified into biochemical recurrence (nadir-PSA ≤0.4 ng/ml) or persistence (nadir-PSA >0.4 ng/ml) groups, based on the cut-off reported in the original trial. Inverse probability of treatment weighting (IPTW) methodology was utilized to minimize the baseline differences among groups. Competing-risk and Kaplan-Meier analyses estimated the impact of prostate-specific antigen (PSA) persistence vs. recurrence on local and metastatic disease progression and overall-mortality in the IPTW-adjusted model; a 2-sided P < 0.05 was considered significant.
RESULTS


All patients received sRT, and about 50% of the patients in either group received concomitant antiandrogen therapy (P = 0.951). The median follow-up was 12 years. After IPTW, the 2 groups were well-matched with standardized mean differences ∼10%. In the IPTW-adjusted cohort, the 10-year local and metastatic disease occurrence rates were 3.2% vs. 1.4% (Gray's P = 0.0001) and 28.6% vs. 10.1% (Gray's P < 0.0001) in patients with persistent vs. recurrent PSA, respectively. Similarly, the 10-year overall-mortality rates were 24.9% vs. 11.9% (Log-rank P = 0.029), respectively.
CONCLUSIONS


Patients with biochemical persistence after RP are approximately 2.5 times more likely to experience local/metastatic failure and death, compared to patients with biochemical recurrence after RP, despite equivalent sRT with/without antiandrogen therapy use. These data may facilitate patient counseling and shared treatment selection.",2020,"CONCLUSIONS


Patients with biochemical persistence after RP are approximately 2.5 times more likely to experience local/metastatic failure and death, compared to patients with biochemical recurrence after RP, despite equivalent sRT with/without antiandrogen therapy use.","['Data on 760 men who participated in the RTOG 9601 trial were extracted using the NCTN data archive platform', 'men with node-negative prostate cancer at']","['salvage radiation therapy (sRT', 'concomitant antiandrogen therapy', 'radical prostatectomy and undergo salvage radiation therapy', 'radical prostatectomy (RP']","['10-year local and metastatic disease occurrence rates', 'mortality rates', '10-year overall-mortality rates', 'prostate-specific antigen (PSA) persistence vs. recurrence on local and metastatic disease progression and overall-mortality', 'overall mortality rates']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0003738'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.133824,"CONCLUSIONS


Patients with biochemical persistence after RP are approximately 2.5 times more likely to experience local/metastatic failure and death, compared to patients with biochemical recurrence after RP, despite equivalent sRT with/without antiandrogen therapy use.","[{'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Sood', 'Affiliation': 'VCORE - Vattikuti Urology Institute Center for Outcomes Research, Analytics and Evaluation, Henry Ford Hospital, Detroit, MI; Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI. Electronic address: asood1@hfhs.org.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Keeley', 'Affiliation': 'VCORE - Vattikuti Urology Institute Center for Outcomes Research, Analytics and Evaluation, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Palma-Zamora', 'Affiliation': 'VCORE - Vattikuti Urology Institute Center for Outcomes Research, Analytics and Evaluation, Henry Ford Hospital, Detroit, MI; Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Sohrab', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'VCORE - Vattikuti Urology Institute Center for Outcomes Research, Analytics and Evaluation, Henry Ford Hospital, Detroit, MI; Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Deepansh', 'Initials': 'D', 'LastName': 'Dalela', 'Affiliation': 'VCORE - Vattikuti Urology Institute Center for Outcomes Research, Analytics and Evaluation, Henry Ford Hospital, Detroit, MI; Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Olson', 'Affiliation': 'Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Hanna', 'Affiliation': 'Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cotter', 'Affiliation': 'Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Wooju', 'Initials': 'W', 'LastName': 'Jeong', 'Affiliation': 'Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elshaikh', 'Affiliation': 'Department of Radiation Oncology, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Craig G', 'Initials': 'CG', 'LastName': 'Rogers', 'Affiliation': 'VCORE - Vattikuti Urology Institute Center for Outcomes Research, Analytics and Evaluation, Henry Ford Hospital, Detroit, MI; Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Peabody', 'Affiliation': 'VCORE - Vattikuti Urology Institute Center for Outcomes Research, Analytics and Evaluation, Henry Ford Hospital, Detroit, MI; Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Mani', 'Initials': 'M', 'LastName': 'Menon', 'Affiliation': 'VCORE - Vattikuti Urology Institute Center for Outcomes Research, Analytics and Evaluation, Henry Ford Hospital, Detroit, MI; Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Firas', 'Initials': 'F', 'LastName': 'Abdollah', 'Affiliation': 'VCORE - Vattikuti Urology Institute Center for Outcomes Research, Analytics and Evaluation, Henry Ford Hospital, Detroit, MI; Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI.'}]",Urologic oncology,['10.1016/j.urolonc.2020.02.024']
326,32228238,Reach Out Emergency Department: Partnering With an Economically Disadvantaged Community in the Development of a Text-Messaging Intervention to Address High Blood Pressure.,"Background.  Hypertension affects nearly 30% of the U.S. adult population. Due to the ubiquitous nature of mobile phone usage, text messaging offers a promising platform for interventions to assist in the management of chronic diseases including hypertension, including among populations that are historically underserved. We present the intervention development of Reach Out, a health behavior theory-based, mobile health intervention to reduce blood pressure among hypertensive patients evaluated in a safety net emergency department primarily caring for African Americans.  Aims.  To describe the process of designing and refining text messages currently being implemented in the Reach Out randomized controlled trial.  Method.  We used a five-step framework to develop the text messages used in Reach Out. These steps included literature review and community formative research, conception of a community-centered behavioral theoretical framework, draft of evidence-based text messages, community review, and revision based on community feedback and finalization.  Results . The Reach Out development process drew from pertinent evidence that, combined with community feedback, guided the development of a community-centered health behavior theory framework that led to development of text messages. A total of 333 generic and segmented messages were created. Messages address dietary choices, physical activity, hypertension medication adherence, and blood pressure monitoring.  Discussion.  Our five-step framework is intended to inform future text-messaging-based health promotion efforts to address health issues in vulnerable populations.  Conclusion . Text message-based health promotion programs should be developed in partnership with the local community to ensure acceptability and relevance.",2020,"Due to the ubiquitous nature of mobile phone usage, text messaging offers a promising platform for interventions to assist in the management of chronic diseases including hypertension, including among populations that are historically underserved.","['Reach Out Emergency Department', 'hypertensive patients evaluated in a safety net emergency department primarily caring for African Americans']",[],"['physical activity, hypertension medication adherence, and blood pressure monitoring', 'blood pressure', 'Hypertension']","[{'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",333.0,0.0398859,"Due to the ubiquitous nature of mobile phone usage, text messaging offers a promising platform for interventions to assist in the management of chronic diseases including hypertension, including among populations that are historically underserved.","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Champoux', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Price', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Joan E', 'Initials': 'JE', 'LastName': 'Cowdery', 'Affiliation': 'Eastern Michigan University, Ypsilanti, MI, USA.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Dinh', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Meurer', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Narmeen', 'Initials': 'N', 'LastName': 'Rehman', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Schille', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Oliver', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Devin L', 'Initials': 'DL', 'LastName': 'Brown', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Killingsworth', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Lesli E', 'Initials': 'LE', 'LastName': 'Skolarus', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}]",Health promotion practice,['10.1177/1524839920913550']
327,32228267,An effective early death scoring system for predicting early death risk in  de novo  acute promyelocytic leukemia.,"The Sanz risk, which was originally used to predict the risk of acute promyelocytic leukemia (APL) relapse, is a recognized method to predict the prognosis of APL. About 570  de novo  APL patients admitted to our center were randomly divided into a training cohort ( N  = 344) and validation cohort ( N  = 226). Multivariate analysis of training cohort demonstrated that age >52 (OR = 5.170,  p  = .002), white blood cell count >10 × 10 9 /L (OR = 9.062,  p  < .001), PLT count ≤10 × 10 9 /L (OR = 4.254,  p  < .001), and LDH level >500 U/L (OR= 3.002,  p  = .046) were independent risk factors for early death. A risk score (age >52: 1.5 points; WBC >10 × 10 9 /L: 2 points; PLT ≤10 × 10 9 /L: 1 point; LDH >500 U/L: 1 point) was used to predict early death risk. The model shows a better predictive power of early death in training cohort and validation cohort compared with Sanz risk stratification.",2020,"Multivariate analysis of training cohort demonstrated that age >52 (OR = 5.170,  p  = .002), white blood cell count >10 × 10 9 /L (OR = 9.062,  p  < .001), PLT count ≤10 ","['de novo  APL patients admitted to our center', 'de novo  acute promyelocytic leukemia', 'About 570']",[],"['LDH level', 'white blood cell count', 'acute promyelocytic leukemia (APL) relapse']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0023487', 'cui_str': 'Myeloid Leukemia, Acute, M3'}]",[],"[{'cui': 'C0022922', 'cui_str': 'lactate dehydrogenase-K'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0023487', 'cui_str': 'Myeloid Leukemia, Acute, M3'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",570.0,0.0287751,"Multivariate analysis of training cohort demonstrated that age >52 (OR = 5.170,  p  = .002), white blood cell count >10 × 10 9 /L (OR = 9.062,  p  < .001), PLT count ≤10 ","[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Cai', 'Affiliation': 'NHC Key Laboratory of Thrombosis and Hemostasis, National Clinical Research Center for Hematologic Diseases, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'NHC Key Laboratory of Thrombosis and Hemostasis, National Clinical Research Center for Hematologic Diseases, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Yemin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'NHC Key Laboratory of Thrombosis and Hemostasis, National Clinical Research Center for Hematologic Diseases, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'NHC Key Laboratory of Thrombosis and Hemostasis, National Clinical Research Center for Hematologic Diseases, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Xinyou', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Hematology, Second Clinical Medical College of Jinan University, Shenzhen People's Hospital, Shenzhen, China.""}, {'ForeName': 'Suning', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'NHC Key Laboratory of Thrombosis and Hemostasis, National Clinical Research Center for Hematologic Diseases, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}]",Leukemia & lymphoma,['10.1080/10428194.2020.1742910']
328,32228789,"Effects of Individual and Combined Water, Sanitation, Handwashing, and Nutritional Interventions on Child Respiratory Infections in Rural Kenya: A Cluster-Randomized Controlled Trial.","Poor nutrition and hand hygiene are risk factors for acute respiratory infections (ARIs). Safe drinking water and sanitation can reduce exposure to pathogens and encourage healthy immune responses, reducing the risk of ARIs. Within a trial assessing impacts of water, sanitation, and handwashing (WASH), and nutritional interventions, we evaluated effects on ARIs. The WASH Benefits cluster-randomized trial enrolled pregnant women from Kenyan villages and evaluated health outcomes in children born to enrolled mothers 1 and 2 years after intervention delivery. Geographically adjacent clusters were block-randomized into a passive control (no promotional visits), a double-sized active control (monthly visits to measure mid-upper arm circumference), and six intervention groups: chlorinated drinking water (W), improved sanitation (S), handwashing with soap (H), combined WSH, improved nutrition (N) through counseling and lipid-based nutrient supplementation (LNS), and combined WSHN. The main outcome was the prevalence of ARI symptoms (cough, panting, wheezing, or difficulty breathing) in children younger than 3 years. Masking participants was not possible. Analyses were intention-to-treat. Between November 2012 and May 2014, 702 clusters were enrolled, including 6,960 (year 1) and 7,088 (year 2) children with ARI data. The cluster-level intra-cluster correlation coefficient for ARIs was 0.026 across both years. Water, sanitation, and handwashing interventions with behavior change messaging did not reduce ARIs. Nutrition counseling and LNS modestly reduced ARI symptoms compared with controls in year 1 [prevalence ratio (PR): 0.87, 95% confidence interval (CI): 0.77-0.99], but no effect in the combined WSHN group weakens this finding.",2020,"Safe drinking water and sanitation can reduce exposure to pathogens and encourage healthy immune responses, reducing the risk of ARIs.","['pregnant women from Kenyan villages and evaluated health outcomes in children born to enrolled mothers 1 and 2 years after intervention delivery', 'children younger than 3 years', 'Child Respiratory Infections in Rural Kenya', 'Between November 2012 and May 2014, 702 clusters were enrolled, including 6,960 (year 1) and 7,088 (year 2) children with ARI data']","['passive control (no promotional visits), a double-sized active control (monthly visits to measure mid-upper arm circumference), and six intervention groups: chlorinated drinking water (W), improved sanitation (S), handwashing with soap (H), combined WSH, improved nutrition (N) through counseling and lipid-based nutrient supplementation (LNS), and combined WSHN', 'water, sanitation, and handwashing (WASH), and nutritional interventions', 'Individual and Combined Water, Sanitation, Handwashing, and Nutritional Interventions', 'Nutrition counseling and LNS']","['prevalence of ARI symptoms (cough, panting, wheezing, or difficulty breathing', 'ARI symptoms']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0337839', 'cui_str': 'Kenyans (ethnic group)'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3714365', 'cui_str': 'Counseling about nutrition'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0453927', 'cui_str': 'Pants'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",,0.102307,"Safe drinking water and sanitation can reduce exposure to pathogens and encourage healthy immune responses, reducing the risk of ARIs.","[{'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Swarthout', 'Affiliation': 'Civil and Environmental Engineering, Tufts University, Medford, Massachusetts.'}, {'ForeName': 'Pavani K', 'Initials': 'PK', 'LastName': 'Ram', 'Affiliation': 'Epidemiology and Environmental Health, University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, California.'}, {'ForeName': 'Holly N', 'Initials': 'HN', 'LastName': 'Dentz', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, California.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Arnold', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, California.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Kalungu', 'Affiliation': 'Innovations for Poverty Action, Nairobi, Kenya.'}, {'ForeName': 'Audrie', 'Initials': 'A', 'LastName': 'Lin', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, Berkeley, Berkeley, California.'}, {'ForeName': 'Sammy M', 'Initials': 'SM', 'LastName': 'Njenga', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Stewart', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, California.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Colford', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, Berkeley, Berkeley, California.'}, {'ForeName': 'Clair', 'Initials': 'C', 'LastName': 'Null', 'Affiliation': 'Center for International Policy Research and Evaluation, Mathematica Policy Research, Washington, District of Columbia.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Pickering', 'Affiliation': 'Civil and Environmental Engineering, Tufts University, Medford, Massachusetts.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0779']
329,32229754,Olanzapine for the Prevention of Postdischarge Nausea and Vomiting after Ambulatory Surgery: A Randomized Controlled Trial.,"BACKGROUND


Postdischarge nausea and vomiting after ambulatory surgery is a common problem that is not adequately addressed in current practice. This prospective, randomized, double-blind, parallel-group, placebo-controlled study was designed to test the hypothesis that oral olanzapine is superior to placebo at preventing postdischarge nausea and vomiting.
METHODS


In a single-center, double-blind, randomized, placebo-controlled trial, the authors compared a single preoperative dose of olanzapine 10 mg to placebo, in adult female patients 50 years old or less, undergoing ambulatory gynecologic or plastic surgery with general anesthesia. All patients received standard antiemetic prophylaxis with dexamethasone and ondansetron. The primary composite outcome was nausea and/or vomiting in the 24 h after discharge. Secondary outcomes included severe nausea, vomiting, and side effects.
RESULTS


A total of 140 patients were randomized and evaluable. The primary outcome occurred in 26 of 69 patients (38%) in the placebo group and in 10 of 71 patients (14%) in the olanzapine group (relative risk, 0.37; 95% CI, 0.20 to 0.72; P = 0.003). Severe nausea occurred in 14 patients (20%) in the placebo group and 4 patients (6%) in the olanzapine group (relative risk, 0.28; 95% CI, 0.10 to 0.80). Vomiting occurred in eight patients (12%) in the placebo group and two patients (3%) in the olanzapine group (relative risk, 0.24; 95% CI, 0.05 to 1.10). The median score for sedation (scale 0 to 10, with 10 being highest) in the 24 h after discharge was 4 (interquartile range, 2 to 7) in the placebo group and 6 (interquartile range, 3 to 8) in the olanzapine group (P = 0.023).
CONCLUSIONS


When combined with ondansetron and dexamethasone, the addition of olanzapine relative to placebo decreased the risk of nausea and/or vomiting in the 24 hafter discharge from ambulatory surgery by about 60% with a slight increase in reported sedation.",2020,"Vomiting occurred in eight patients (12%) in the placebo group and two patients (3%) in the olanzapine group (relative risk, 0.24; 95% CI, 0.05 to 1.10).","['140 patients were randomized and evaluable', 'after Ambulatory Surgery', 'adult female patients 50 years old or less, undergoing ambulatory gynecologic or plastic surgery with general anesthesia']","['dexamethasone and ondansetron', 'Olanzapine', 'placebo', 'olanzapine 10 mg to placebo', 'olanzapine', 'ondansetron and dexamethasone']","['Severe nausea', 'Postdischarge Nausea and Vomiting', 'nausea and vomiting', 'postdischarge nausea and vomiting', 'Vomiting', 'risk of nausea and/or vomiting', 'median score for sedation', 'severe nausea, vomiting, and side effects', 'nausea and/or vomiting']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory Surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0038911', 'cui_str': 'Surgery, Plastic'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0988260', 'cui_str': 'olanzapine 10 MG'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",140.0,0.74613,"Vomiting occurred in eight patients (12%) in the placebo group and two patients (3%) in the olanzapine group (relative risk, 0.24; 95% CI, 0.05 to 1.10).","[{'ForeName': 'Jaime B', 'Initials': 'JB', 'LastName': 'Hyman', 'Affiliation': ""From the Department of Anesthesiology, Perioperative and Pain Medicine (J.B.H., C.P., B.C., M.H., S.D.) Department of Population Health Science and Policy (H.-M.L.) Division of Gynecology, Department of Obstetrics, Gynecology and Reproductive Science (L.R., R.L.B.G., V.P., C.A.-W.) Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Blavatnik Family Women's Health Research Institute (S.V.B.) Division of Plastic and Reconstructive Surgery, Department of Surgery (P.J.T.), Icahn School of Medicine at Mount Sinai, New York, New York Suzanne Fenske, M.D., P.C., Brookville, New York (S.S.F.) Department of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital, Boston, Massachusetts (S.B.P.).""}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Hung-Mo', 'Initials': 'HM', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Cole', 'Affiliation': ''}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Rosen', 'Affiliation': ''}, {'ForeName': 'Suzanne S', 'Initials': 'SS', 'LastName': 'Fenske', 'Affiliation': ''}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Barr Grzesh', 'Affiliation': ''}, {'ForeName': 'Stephanie V', 'Initials': 'SV', 'LastName': 'Blank', 'Affiliation': ''}, {'ForeName': 'Sylvie B', 'Initials': 'SB', 'LastName': 'Polsky', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hartnett', 'Affiliation': ''}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Taub', 'Affiliation': ''}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Palvia', 'Affiliation': ''}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'DeMaria', 'Affiliation': ''}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Ascher-Walsh', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003286']
330,32232540,The effects of unilateral and bilateral cerebellar rTMS on human pharyngeal motor cortical activity and swallowing behavior.,"The cerebellum is recognised to bilaterally modulate sensorimotor function and has recently been shown to play a role in swallowing. Unilateral cerebellar repetitive trans-cranial magnetic stimulation (rTMS) excites corticobulbar motor pathways to the pharynx but the effects of bilateral versus unilateral cerebellar rTMS on these pathways are unknown. In this three-part cross-over study, healthy participants (n = 13) were randomly allocated to receive unilateral or bilateral 10 Hz cerebellar rTMS. Participants were intubated with pharyngeal electromyography and/or manometry catheters for motor evoked potentials (MEPs) and pressure recordings. In part 1 of the study, single pulse TMS was used to measure baseline motor cortical pharyngeal MEP (PMEP) and hemispheric cerebellar MEP (CMEP) amplitudes, before cerebellar rTMS was administered. Repeat measures of PMEP amplitude were performed at 15-min intervals for an hour post unilateral and bilateral rTMS. Thereafter, in two further studies, a cortical 'virtual lesion' (V/L) was applied prior to cerebellar rTMS with pre and post PMEPs (part 2) and measurements of swallowing accuracy (part 3) using a behavioural task. Compared to baseline, unilateral and bilateral cerebellar rTMS provoked increases in pharyngeal cortical excitation (P = 0.028, 0.0005, respectively). Bilateral rTMS was significantly more effective than unilateral in causing cortical excitation (P = 0.0005) and in reversing the suppressive neurological (P = 0.0005) and behavioural (P = 0.0005) effects of a cortical V/L. Our findings suggest bilateral cerebellar rTMS has greater facilitatory effects on corticobulbar motor pathways to the pharynx than unilateral stimulation with the potential to be a more effective clinical therapy if its effects are reproduced in populations with neurogenic dysphagia.",2020,Bilateral rTMS was significantly more effective than unilateral in causing cortical excitation (P = 0.0005) and in reversing the suppressive neurological (P = 0.0005) and behavioural (P = 0.0005) effects of a cortical V/L.,['healthy participants (n\u2009=\u200913'],"['unilateral and bilateral cerebellar rTMS', 'unilateral or bilateral 10\xa0Hz cerebellar rTMS', 'Unilateral cerebellar repetitive trans-cranial magnetic stimulation (rTMS', 'pharyngeal electromyography and/or manometry catheters for motor evoked potentials (MEPs) and pressure recordings']","['human pharyngeal motor cortical activity and swallowing behavior', 'PMEP amplitude', 'baseline motor cortical pharyngeal MEP (PMEP) and hemispheric cerebellar MEP (CMEP) amplitudes', 'pharyngeal cortical excitation', 'suppressive neurological']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C3163632', 'cui_str': 'Cranial'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0941139', 'cui_str': 'Manometer catheter'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0117061', 'cui_str': 'exopolysaccharide, Pseudomonas marginalis'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric (qualifier value)'}, {'cui': 'C0205367', 'cui_str': 'Suppressive (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}]",13.0,0.0286059,Bilateral rTMS was significantly more effective than unilateral in causing cortical excitation (P = 0.0005) and in reversing the suppressive neurological (P = 0.0005) and behavioural (P = 0.0005) effects of a cortical V/L.,"[{'ForeName': 'Ayodele', 'Initials': 'A', 'LastName': 'Sasegbon', 'Affiliation': 'Gastrointestinal (GI) Sciences, Division of Diabetes, Endocrinology and Gastroenterology, Faculty of Biology, Medicine and Health, School of Medical Sciences, University of Manchester, Salford Royal Hospital (part of the Manchester Academic Health Sciences Center (MAHSC)), Clinical Sciences Building, Eccles Old Road, Salford, M6 8HD, UK.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Smith', 'Affiliation': 'Division of Cardiovascular Sciences, Manchester Centre for Clinical Neurosciences, Lydia Becker Institute of Immunology and Inflammation, University of Manchester, Salford Royal Hospital, Manchester Academic Health Sciences Centre (MAHSC), Salford, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Bath', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rothwell', 'Affiliation': 'Sobell Department of Motor Neuroscience and Movement Disorders, University College London, London, UK.'}, {'ForeName': 'Shaheen', 'Initials': 'S', 'LastName': 'Hamdy', 'Affiliation': 'Gastrointestinal (GI) Sciences, Division of Diabetes, Endocrinology and Gastroenterology, Faculty of Biology, Medicine and Health, School of Medical Sciences, University of Manchester, Salford Royal Hospital (part of the Manchester Academic Health Sciences Center (MAHSC)), Clinical Sciences Building, Eccles Old Road, Salford, M6 8HD, UK. shaheen.hamdy@manchester.ac.uk.'}]",Experimental brain research,['10.1007/s00221-020-05787-x']
331,31455897,"Body weight, body composition and survival after 1 year: follow-up of a nutritional intervention trial in allo-HSCT recipients.","The role of body weight change in survival among recipients of hematopoietic stem-cell transplantation is controversial. We assessed the effect of optimizing energy and protein intake on 1-year survival, body weight and body composition, and the effect of body weight and body composition on 1-year survival in 117 patients (57 intervention, 60 control) in a randomized controlled trial. Cox regression was used to study effects of the intervention, weight and body composition on death, relapse, and nonrelapse mortality (NRM). We found no significant effect of intervention versus control on death hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.54-2.04, p = 0.88), relapse (HR 1.15, 95% CI 0.48-2.27, p = 0.75), and NRM (HR 0.95, 95% CI 0.39-2.28, p = 0.90). Body weight, fat-free mass index, body fat mass index and total body water changed over time (p < 0.001), similarly in both groups (0.17 ≤ p ≤ 0.98). In multivariable analyses adjusted for group, gender and age, HRs and 95% CIs per one kilo increase in weight were 1.03 (1.01-1.06) and 1.04 (1.01-1.08) for death and NRM after 1 year (p ≤ 0.02), respectively, and 1.08 (1.01-1.15) for relapse after 3 months (p = 0.02). In conclusion, weight gain is possibly due to fluid retention and is an indicator of a complication in HSCT, rather than a marker of improved nutritional status.",2019,"We found no significant effect of intervention versus control on death hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.54-2.04, p = 0.88), relapse (HR 1.15, 95% CI 0.48-2.27, p = 0.75), and NRM (HR 0.95, 95% CI 0.39-2.28, p = 0.90).","['allo-HSCT recipients', '117 patients (57 intervention, 60 control', 'recipients of hematopoietic stem-cell transplantation']",['optimizing energy and protein intake'],"['Body weight, body composition and survival', 'relapse', 'weight and body composition on death, relapse, and nonrelapse mortality (NRM', 'weight', 'Body weight, fat-free mass index, body fat mass index and total body water changed over time', 'weight gain', 'death and NRM', 'death hazard ratio', '1-year survival, body weight and body composition']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0429632', 'cui_str': 'Total body water (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",117.0,0.156154,"We found no significant effect of intervention versus control on death hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.54-2.04, p = 0.88), relapse (HR 1.15, 95% CI 0.48-2.27, p = 0.75), and NRM (HR 0.95, 95% CI 0.39-2.28, p = 0.90).","[{'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Skaarud', 'Affiliation': 'Department of Haematology, Oslo University Hospital, Oslo, Norway. kskaarud@ous-hf.no.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Veierød', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lergenmuller', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bye', 'Affiliation': 'European Palliative Care Research Centre, Department of Oncology, Oslo University Hospital and Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'P O', 'Initials': 'PO', 'LastName': 'Iversen', 'Affiliation': 'Department of Haematology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'G E', 'Initials': 'GE', 'LastName': 'Tjønnfjord', 'Affiliation': 'Department of Haematology, Oslo University Hospital, Oslo, Norway.'}]",Bone marrow transplantation,['10.1038/s41409-019-0638-6']
332,31785250,Nalbuphine for Analgesia After Orthognathic Surgery and Its Effect on Postoperative Inflammatory and Oxidative Stress: A Randomized Double-Blind Controlled Trial.,"PURPOSE


Postoperative pain is a negative factor that seriously affects a surgical patient's rehabilitation. We investigated whether nalbuphine provides superior postoperative analgesia in orthognathic surgery compared with sufentanil and whether the superior analgesia is achieved by the regulation of inflammatory and oxidative stress.
PATIENTS AND METHODS


In the present randomized, double-blind, controlled clinical trial, 60 patients scheduled to undergo orthognathic surgery were randomized to receive 2.5 μg/kg of sufentanil (group S) or 2 mg/kg of nalbuphine (group N) for postoperative controlled intravenous analgesia. The primary outcome variable was the visual analog scale (VAS) score. The secondary outcome variables included the sedation score (Ramsay score) and plasma levels of inflammation factors, including tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6), and oxidant stress factors, including malondialdehyde (MDA) and superoxide dismutase (SOD).
RESULTS


The VAS scores of group N were significantly lower than those of group S, and the Ramsay scores for group N were greater. The plasma levels of TNF-α, IL-6, and MDA for group N were significantly lower than those for group S, and the SOD levels were greater than those for group S. Furthermore, the VAS scores correlated positively with the plasma levels of TNF-α, IL-6, and MDA and correlated negatively with the SOD levels.
CONCLUSIONS


Nalbuphine offers better postoperative analgesia and sedation after orthognathic surgery. Nalbuphine also seems to provide superior postoperative analgesia by reducing inflammatory and oxidative stress.",2020,"The VAS scores of group N was significantly lower than those of group S, and the Ramsay scores for group N was greater.",['60 patients scheduled to undergo orthognathic surgery'],"['Nalbuphine for Analgesia', 'Nalbuphine', 'nalbuphine', 'sufentanil (group S) or 2\xa0mg/kg of nalbuphine', 'sufentanil']","['visual analog scale (VAS) score', 'Ramsay scores', 'SOD levels', 'Postoperative Inflammatory and Oxidative Stress', 'VAS scores', 'sedation score (Ramsay score) and plasma levels of inflammation factors, including tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6), and oxidant stress factors, including malondialdehyde (MDA) and superoxide dismutase (SOD', 'postoperative analgesia and sedation', 'plasma levels of TNF-α, IL-6, and MDA']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}]","[{'cui': 'C0027348', 'cui_str': 'Nalbuphine'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0441853', 'cui_str': 'Group S (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}]",60.0,0.400606,"The VAS scores of group N was significantly lower than those of group S, and the Ramsay scores for group N was greater.","[{'ForeName': 'Meng Ying', 'Initials': 'MY', 'LastName': 'Xi', 'Affiliation': 'Resident, College of Stomatology, Chongqing Medical University; Chongqing Key Laboratory of Oral Diseases and Biomedical Sciences; Chongqing Municipal Key Laboratory of Oral Biomedical Engineering of Higher Education, Chongqing, China.'}, {'ForeName': 'Si Si', 'Initials': 'SS', 'LastName': 'Li', 'Affiliation': 'Resident, Department of Anesthesiology, Affiliated Hospital of Stomatology, Chongqing Medical University; Chongqing Key Laboratory of Oral Diseases and Biomedical Sciences; and Chongqing Municipal Key Laboratory of Oral Biomedical Engineering of Higher Education, Chongqing, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Resident, Department of Anesthesiology, Affiliated Hospital of Stomatology, Chongqing Medical University; Chongqing Key Laboratory of Oral Diseases and Biomedical Sciences; and Chongqing Municipal Key Laboratory of Oral Biomedical Engineering of Higher Education, Chongqing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Resident, College of Stomatology, Chongqing Medical University; Chongqing Key Laboratory of Oral Diseases and Biomedical Sciences; Chongqing Municipal Key Laboratory of Oral Biomedical Engineering of Higher Education, Chongqing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Professor, Department of Oral and Maxillofacial Surgery, Affiliated Hospital of Stomatology, Chongqing Medical University; Chongqing Key Laboratory of Oral Diseases and Biomedical Sciences; and Chongqing Municipal Key Laboratory of Oral Biomedical Engineering of Higher Education, Chongqing, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Professor, Department of Anesthesiology, Affiliated Hospital of Stomatology, Chongqing Medical University; Chongqing Key Laboratory of Oral Diseases and Biomedical Sciences; and Chongqing Municipal Key Laboratory of Oral Biomedical Engineering of Higher Education, Chongqing, China. Electronic address: 500158@hospital.cqmu.edu.cn.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.10.017']
333,31623894,"Effects of tranexamic acid on death, disability, vascular occlusive events and other morbidities in patients with acute traumatic brain injury (CRASH-3): a randomised, placebo-controlled trial.","BACKGROUND


Tranexamic acid reduces surgical bleeding and decreases mortality in patients with traumatic extracranial bleeding. Intracranial bleeding is common after traumatic brain injury (TBI) and can cause brain herniation and death. We aimed to assess the effects of tranexamic acid in patients with TBI.
METHODS


This randomised, placebo-controlled trial was done in 175 hospitals in 29 countries. Adults with TBI who were within 3 h of injury, had a Glasgow Coma Scale (GCS) score of 12 or lower or any intracranial bleeding on CT scan, and no major extracranial bleeding were eligible. The time window for eligibility was originally 8 h but in 2016 the protocol was changed to limit recruitment to patients within 3 h of injury. This change was made blind to the trial data, in response to external evidence suggesting that delayed treatment is unlikely to be effective. We randomly assigned (1:1) patients to receive tranexamic acid (loading dose 1 g over 10 min then infusion of 1 g over 8 h) or matching placebo. Patients were assigned by selecting a numbered treatment pack from a box containing eight packs that were identical apart from the pack number. Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcome was head injury-related death in hospital within 28 days of injury in patients treated within 3 h of injury. We prespecified a sensitivity analysis that excluded patients with a GCS score of 3 and those with bilateral unreactive pupils at baseline. All analyses were done by intention to treat. This trial was registered with ISRCTN (ISRCTN15088122), ClinicalTrials.gov (NCT01402882), EudraCT (2011-003669-14), and the Pan African Clinical Trial Registry (PACTR20121000441277).
RESULTS


Between July 20, 2012, and Jan 31, 2019, we randomly allocated 12 737 patients with TBI to receive tranexamic acid (6406 [50·3%] or placebo [6331 [49·7%], of whom 9202 (72·2%) patients were treated within 3 h of injury. Among patients treated within 3 h of injury, the risk of head injury-related death was 18·5% in the tranexamic acid group versus 19·8% in the placebo group (855 vs 892 events; risk ratio [RR] 0·94 [95% CI 0·86-1·02]). In the prespecified sensitivity analysis that excluded patients with a GCS score of 3 or bilateral unreactive pupils at baseline, the risk of head injury-related death was 12·5% in the tranexamic acid group versus 14·0% in the placebo group (485 vs 525 events; RR 0·89 [95% CI 0·80-1·00]). The risk of head injury-related death reduced with tranexamic acid in patients with mild-to-moderate head injury (RR 0·78 [95% CI 0·64-0·95]) but not in patients with severe head injury (0·99 [95% CI 0·91-1·07]; p value for heterogeneity 0·030). Early treatment was more effective than was later treatment in patients with mild and moderate head injury (p=0·005) but time to treatment had no obvious effect in patients with severe head injury (p=0·73). The risk of vascular occlusive events was similar in the tranexamic acid and placebo groups (RR 0·98 (0·74-1·28). The risk of seizures was also similar between groups (1·09 [95% CI 0·90-1·33]).
INTERPRETATION


Our results show that tranexamic acid is safe in patients with TBI and that treatment within 3 h of injury reduces head injury-related death. Patients should be treated as soon as possible after injury.
FUNDING


National Institute for Health Research Health Technology Assessment, JP Moulton Charitable Trust, Department of Health and Social Care, Department for International Development, Global Challenges Research Fund, Medical Research Council, and Wellcome Trust (Joint Global Health Trials scheme).
TRANSLATIONS


For the Arabic, Chinese, French, Hindi, Japanese, Spanish and Urdu translations of the abstract see Supplementary Material.",2019,Early treatment was more effective than was later treatment in patients with mild and moderate head injury (p=0·005) but time to treatment had no obvious effect in patients with severe head injury (p=0·73).,"['patients with traumatic extracranial bleeding', '175 hospitals in 29 countries', '737 patients with TBI to receive', 'Adults with TBI who were within 3 h of injury, had a Glasgow Coma Scale (GCS) score of 12 or lower or any intracranial bleeding on CT scan, and no major extracranial bleeding were eligible', 'patients with acute traumatic brain injury (CRASH-3', 'excluded patients with a GCS score of 3 and those with bilateral unreactive pupils at baseline', 'patients with TBI', 'Between July 20, 2012, and Jan 31, 2019']","['tranexamic acid', 'Tranexamic acid', 'placebo', 'tranexamic acid and placebo', 'tranexamic acid (loading dose', 'EudraCT']","['risk of seizures', 'risk of head injury-related death', 'time window for eligibility', 'risk of vascular occlusive events', 'Intracranial bleeding', 'death, disability, vascular occlusive events and other morbidities', 'head injury-related death in hospital within 28 days of injury']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0580586', 'cui_str': 'Extracranial (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041119', 'cui_str': 'Hydrogen-3'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3714444', 'cui_str': 'Loading dose'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0018674', 'cui_str': 'Head Trauma'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0557702', 'cui_str': 'Window (physical object)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0277608', 'cui_str': 'Death in hospital (event)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]",8.0,0.76451,Early treatment was more effective than was later treatment in patients with mild and moderate head injury (p=0·005) but time to treatment had no obvious effect in patients with severe head injury (p=0·73).,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)32233-0']
334,31884075,Comparing Different Music Genres in Decreasing Dental Anxiety in Young Adults Who Underwent Third Molar Surgery in Turkey: Randomized Controlled Trial.,"PURPOSE


The purpose of this study was to determine the music genre reducing anxiety best in patients whose third molars were extracted.
MATERIALS AND METHODS


Eighty patients were included in this prospective, observational, randomized controlled trial. They were divided into 4 groups: group 1, Turkish music; group 2, classical music of a Western culture; group 3, soft rock music; and group 4, no music (control group). The preoperative blood pressure, heart rate (HR), and oxygen saturation of each patient were measured, and the Corah Dental Anxiety Scale (CDAS) questionnaire was applied, with the values being measured and recorded at 5-minute intervals. Descriptive and bivariate statistics were computed, and the P value was set at .05.
RESULTS


Of the 80 patients, 44 were women and 36 were men. The average age was 24.1 ± 5.9 years. No significant differences between the groups were found in terms of age; gender; or preoperative HR, mean arterial pressure, oxygen saturation (as measured by pulse oximetry), and CDAS values (P > .05). Although no significant correlations was found between anxiety levels and age (P = .330), HR (P = .694), or mean arterial pressure (P = .775), it was detected that anxiety was high in women (P < .05). Anxiety levels decreased at all times in all groups, but the postoperative CDAS values of the classical music group were significantly lower than those of the other groups (P = .024).
CONCLUSIONS


This study found that classical Western music that was started in the preoperative period and continued until the end of the operation significantly reduced the anxiety associated with third molar extraction in patients aged between 18 and 30 years.",2020,"No significant differences between the groups were found in terms of age; gender; or preoperative HR, mean arterial pressure, oxygen saturation (as measured by pulse oximetry), and CDAS values (P > .05). ","['patients whose third molars were extracted', '80 patients', 'Eighty patients', 'Young Adults', 'Who Underwent Third Molar Surgery in Turkey', '44 were women and 36 were men', 'patients aged between 18 and 30\xa0years']","['Music Genres', 'Turkish music; group 2, classical music of a Western culture; group 3, soft rock music; and group 4, no music (control group']","['Dental Anxiety', 'mean arterial pressure', 'Anxiety levels', 'preoperative blood pressure, heart rate (HR), and oxygen saturation of each patient', 'anxiety levels', 'anxiety', 'Corah Dental Anxiety Scale (CDAS) questionnaire', 'age; gender; or preoperative HR, mean arterial pressure, oxygen saturation (as measured by pulse oximetry), and CDAS values', 'postoperative CDAS values']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0554967', 'cui_str': 'Turkish (NMO) (ethnic group)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0681251', 'cui_str': 'Classical Music'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0205358', 'cui_str': 'Soft (qualifier value)'}, {'cui': 'C0441876', 'cui_str': 'Group 4 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0085380', 'cui_str': 'Fear, Dental'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034108', 'cui_str': 'Oximetry, Pulse'}, {'cui': 'C0002876', 'cui_str': 'Congenital dyserythropoietic anemia (disorder)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",80.0,0.0354906,"No significant differences between the groups were found in terms of age; gender; or preoperative HR, mean arterial pressure, oxygen saturation (as measured by pulse oximetry), and CDAS values (P > .05). ","[{'ForeName': 'Ilke', 'Initials': 'I', 'LastName': 'Kupeli', 'Affiliation': 'Associate Professor, Anesthesiology and Reanimation Department, Erzincan Binali Yıldırım University, Erzincan, Turkey. Electronic address: ilkeser2004@gmail.com.'}, {'ForeName': 'Yakup', 'Initials': 'Y', 'LastName': 'Gülnahar', 'Affiliation': 'Assistant Professor, Oral and Maxillofacial Surgery Department, Erzincan Binali Yıldırım University, Erzincan, Turkey.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.11.029']
335,31783004,"Analgesic and Anti-Inflammatory Effects of Articaine and Perineural Dexamethasone for Mandibular Third Molar Surgery: A Randomized, Double-Blind Study.","PURPOSE


We aimed to investigate the effectiveness of articaine and perineural dexamethasone (DX) in reducing postoperative sequelae such as swelling and maximum mouth opening that are harming the quality of life of patients after impacted mandibular third molar (IMTM) surgery.
PATIENTS AND METHODS


We implemented a randomized clinical trial composed of patients undergoing IMTM extraction. The predictor variable was the treatment group. The patients were randomly assigned to 1 of 3 groups: Group A was administered 3.6 mL of articaine mixed with 2 mL of saline solution; group B, 3.6 mL of articaine and 1 mL of DX (4-mg/mL solution) with 1 mL of saline solution; and group C, 3.6 mL of articaine with 2 mL of DX (8-mg/mL solution). The primary outcome variables were swelling (determined by anatomic facial landmarks), pain, and maximum mouth opening. Other variables comprised the duration of surgery, number of analgesics taken in the postoperative period, hygiene, and petechiae.
RESULTS


The sample was composed of 60 patients (20 per treatment group), with a mean age of 25.18 ± 5.22 years; 53.3% were women. Postoperative swelling was significantly reduced in groups B and C (P < .05). Maximum mouth opening was significantly increased in groups B and C (P < .05).
CONCLUSIONS


The results of this study suggest that combining DX with articaine improves the management of discomfort after IMTM surgery. The use of articaine via a mandibular block was not associated with neural damage in our study.",2020,Maximum mouth opening was significantly increased in groups B and C (P ,"['Mandibular Third Molar Surgery', '60 patients (20 per treatment group), with a mean age of 25.18\xa0±\xa05.22\xa0years; 53.3% were women', 'patients undergoing IMTM extraction', 'patients after impacted mandibular third molar (IMTM) surgery']","['articaine and 1\xa0mL of DX (4-mg/mL solution) with 1\xa0mL of saline solution', 'articaine and perineural dexamethasone (DX', 'articaine mixed with 2\xa0mL of saline solution', 'Articaine and Perineural Dexamethasone', 'articaine', 'articaine with 2\xa0mL of DX']","['Maximum mouth opening', 'swelling (determined by anatomic facial landmarks), pain, and maximum mouth opening', 'Postoperative swelling', 'duration of surgery, number of analgesics taken in the postoperative period, hygiene, and petechiae']","[{'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]","[{'cui': 'C1608295', 'cui_str': 'Articaine'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1720722', 'cui_str': 'Mix'}]","[{'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0031256', 'cui_str': 'Petechia (morphologic abnormality)'}]",60.0,0.441043,Maximum mouth opening was significantly increased in groups B and C (P ,"[{'ForeName': 'Berkem', 'Initials': 'B', 'LastName': 'Atalay', 'Affiliation': 'Assistant Professor, Vocational School of Health Sciences, İstanbul University-Cerrahpaşa, Istanbul, Turkey. Electronic address: berkematalay@gmail.com.'}, {'ForeName': 'Abdullah Tolga', 'Initials': 'AT', 'LastName': 'Şitilci', 'Affiliation': 'Assistant Professor, Department of Oral Surgery, Faculty of Dentistry, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Özen Doğan', 'Initials': 'ÖD', 'LastName': 'Onur', 'Affiliation': 'Professor, Department of Oral Surgery, Faculty of Dentistry, Istanbul University, Istanbul, Turkey.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.10.024']
336,30538282,Prefronto-cerebellar neuromodulation affects appetite in obesity.,"Human neuroimaging studies have consistently reported changes in cerebellar function and integrity in association with obesity. To date, however, the nature of this link has not been studied directly. Emerging evidence suggests a role for the cerebellum in higher cognitive functions through reciprocal connections with the prefrontal cortex. The purpose of this exploratory study was to examine appetite changes associated with noninvasive prefronto-cerebellar neuromodulation in obesity. Totally, 12 subjects with class I obesity (mean body mass index 32.9 kg/m 2 ) underwent a randomized, single-blinded, sham-controlled, crossover study, during which they received transcranial direct current stimulation ((tDCS); active/sham) aimed at simultaneously enhancing the activity of the prefrontal cortex and decreasing the activity of the cerebellum. Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated. We found that active tDCS caused an increase in hunger and desire to eat following food-cue exposure. In line with these data, subjects also tended to make more errors during the working memory task. No changes in basic motor performance occurred. This study represents the first demonstration that prefronto-cerebellar neuromodulation can influence appetite in individuals with obesity. While preliminary, our findings support a potential role for prefronto-cerebellar pathways in the behavioral manifestations of obesity.",2019,Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated.,"['individuals with obesity', '12 subjects with class']","['transcranial direct current stimulation ((tDCS); active/sham', 'active tDCS', 'prefronto-cerebellar neuromodulation', 'Prefronto-cerebellar neuromodulation']","['basic motor performance', 'appetite (state and food-cue-triggered) and performance', 'hunger and desire to eat']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]",12.0,0.0223505,Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated.,"[{'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Marron', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain. emunozmarr@uoc.edu.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Viejo-Sobera', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Guillem', 'Initials': 'G', 'LastName': 'Cuatrecasas', 'Affiliation': 'Endocrinology Department, Clínica Sagrada Familia. Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Redolar-Ripoll', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Pilar García', 'Initials': 'PG', 'LastName': 'Lorda', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Datta', 'Affiliation': 'Soterix Medical, New York City, NY, USA.'}, {'ForeName': 'Marom', 'Initials': 'M', 'LastName': 'Bikson', 'Affiliation': 'Department of Biomedical Engineering, City College of New York (CCNY), New York, NY, USA.'}, {'ForeName': 'Greta', 'Initials': 'G', 'LastName': 'Magerowski', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Alonso-Alonso', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. malonso@bidmc.harvard.edu.'}]",International journal of obesity (2005),['10.1038/s41366-018-0278-8']
337,32223963,Multi-omic analysis of the effects of low frequency ventilation during cardiopulmonary bypass surgery.,"BACKGROUND


Heart surgery with cardio-pulmonary bypass (CPB) is associated with lung ischemia leading to injury and inflammation. It has been suggested this is a result of the lungs being kept deflated throughout the duration of CPB. Low frequency ventilation (LFV) during CPB has been proposed to reduce lung dysfunction.
METHODS


We used a semi-biased multi-omic approach to analyse lung biopsies taken before and after CPB from 37 patients undergoing coronary artery bypass surgery randomised to both lungs left collapsed or using LFV for the duration of CPB. We also examined inflammatory and oxidative stress markers from blood samples from the same patients.
RESULTS


30 genes were induced when the lungs were left collapsed and 80 by LFV. Post-surgery 26 genes were significantly higher in the LFV vs. lungs left collapsed, including genes associated with inflammation (e.g. IL6 and IL8) and hypoxia/ischemia (e.g. HIF1A, IER3 and FOS). Relatively few changes in protein levels were detected, perhaps reflecting the early time point or the importance of post-translational modifications. However, pathway analysis of proteomic data indicated that LFV was associated with increased ""cellular component morphogenesis"" and a decrease in ""blood circulation"". Lipidomic analysis did not identify any lipids significantly altered by either intervention.
DISCUSSION


Taken together these data indicate the keeping both lungs collapsed during CPB significantly induces lung damage, oxidative stress and inflammation. LFV during CPB increases these deleterious effects, potentially through prolonged surgery time, further decreasing blood flow to the lungs and enhancing hypoxia/ischemia.",2020,"Post-surgery 26 genes were significantly higher in the LFV vs. lungs left collapsed, including genes associated with inflammation (e.g. IL6 and IL8) and hypoxia/ischemia (e.g. HIF1A, IER3 and FOS).","['blood samples from the same patients', '37 patients undergoing coronary artery bypass surgery']","['low frequency ventilation', 'semi-biased multi-omic approach', 'LFV', 'cardiopulmonary bypass surgery', 'Low frequency ventilation (LFV', 'cardio-pulmonary bypass (CPB']","['protein levels', 'lung damage, oxidative stress and inflammation', 'inflammation (e.g. IL6 and IL8) and hypoxia/ischemia (e.g. HIF1A, IER3 and FOS', 'blood flow to the lungs and enhancing hypoxia/ischemia', 'blood circulation']","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}]","[{'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0005775', 'cui_str': 'Blood Circulation'}]",37.0,0.0239128,"Post-surgery 26 genes were significantly higher in the LFV vs. lungs left collapsed, including genes associated with inflammation (e.g. IL6 and IL8) and hypoxia/ischemia (e.g. HIF1A, IER3 and FOS).","[{'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Durham', 'Affiliation': 'Airways Disease Section, National Heart and Lung Institute, Imperial College London, Dovehouse Street, London SW3 6LY, UK; Immunobiology, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 4 Newark St, London, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Al Jaaly', 'Affiliation': 'Cardiothoracic Surgery, National Heart and Lung Institute, Imperial College London, Hammersmith Hospital, London, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Graham', 'Affiliation': 'Airways Disease Section, National Heart and Lung Institute, Imperial College London, Dovehouse Street, London SW3 6LY, UK.'}, {'ForeName': 'P O', 'Initials': 'PO', 'LastName': 'Brook', 'Affiliation': 'Airways Disease Section, National Heart and Lung Institute, Imperial College London, Dovehouse Street, London SW3 6LY, UK.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Bae', 'Affiliation': 'Airways Disease Section, National Heart and Lung Institute, Imperial College London, Dovehouse Street, London SW3 6LY, UK.'}, {'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Heesom', 'Affiliation': 'University of Bristol, Proteomics Facility, BioMedical Sciences Building, University Walk, Bristol, UK.'}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Postle', 'Affiliation': 'Faculty of Medicine, University of Southampton, Building 85, Life Sciences Building, Highfield Campus, Southampton, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lavender', 'Affiliation': ""Department of Asthma, Allergy, and Respiratory Science, King's College London, London, UK.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jazrawi', 'Affiliation': 'Airways Disease Section, National Heart and Lung Institute, Imperial College London, Dovehouse Street, London SW3 6LY, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Reeves', 'Affiliation': 'Cardiothoracic Surgery, National Heart and Lung Institute, Imperial College London, Hammersmith Hospital, London, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Fiorentino', 'Affiliation': 'Cardiothoracic Surgery, National Heart and Lung Institute, Imperial College London, Hammersmith Hospital, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mumby', 'Affiliation': 'Airways Disease Section, National Heart and Lung Institute, Imperial College London, Dovehouse Street, London SW3 6LY, UK.'}, {'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Angelini', 'Affiliation': 'Cardiothoracic Surgery, National Heart and Lung Institute, Imperial College London, Hammersmith Hospital, London, UK; Bristol Heart Institute, University of Bristol, Bristol Royal Infirmary, Level 7, Marlborough Street, Bristol, UK. Electronic address: g.d.angelini@bristol.ac.uk.'}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Adcock', 'Affiliation': 'Airways Disease Section, National Heart and Lung Institute, Imperial College London, Dovehouse Street, London SW3 6LY, UK.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.03.054']
338,32065000,CYP2C19 and CYP3A4 activity and ADP-induced platelet reactivity in prasugrel- or ticagrelor-treated STEMI patients: monocentric study in PRAGUE-18 trial participants.,"We assessed the contribution of CYP2C19 and CYP3A4 metabolic activity to the ADP-induced platelet aggregation 1h and 24h after a loading dose of 60 mg prasugrel or 180 mg ticagrelor in patients with ST-elevation myocardial infarction (STEMI). Further, we assessed the contribution of CYP2C19 polymorphisms and medication to the CYP enzymatic activity.Patients with STEMI were randomly assigned to the treatment with prasugrel ( n  = 51) or ticagrelor ( n  = 46). Metabolic activity of CYP2C19 and CYP3A4 was assessed by the rate of 5-hydroxylation and sulfoxidation of lansoprazole. Further, patients were genotyped for CYP2C19 *2 and *17 alleles.In prasugrel-treated patients, high ADP-induced platelet reactivity 1h after the loading dose positively correlated with 5OH-lansoprazole/lansoprazole ratio ( r  = 0.44,  p  = 0.002), a marker of CYP2C19 metabolic activity, and negatively with lansoprazole-sulfone/lansoprazole ratio, which reflects CYP3A4 metabolic activity ( r  = -0.35,  p  = 0.018).CYP2C19 poor metabolizers had lower 5OH-lansoprazole/lansoprazole ratio and higher lansoprazole-sulfone/lansoprazole ratio, but without any effect on the ADP-induced platelet reactivity. The treatment with amiodarone, a CYP3A4 inhibitor, influenced neither the metabolic ratios nor the ADP-induced platelet reactivity.The CYP3A4 and CYP2C19 metabolic activity is associated with ADP-induced platelet reactivity in prasugrel-treated, but not ticagrelor-treated patients with STEMI.",2020,"The treatment with amiodarone, a CYP3A4 inhibitor, influenced neither the metabolic ratios nor the ADP-induced platelet reactivity.","['Prasugrel- or Ticagrelor-treated STEMI Patients', 'patients with ST-elevations myocardial infarction (STEMI', 'Patients with STEMI']","['ticagrelor', 'lansoprazole/lansoprazole', 'prasugrel', 'lansoprazole', 'amiodarone', 'CYP2C19', '5OH-lansoprazole/lansoprazole']","['platelet reactivity', 'ADP-induced platelet reactivity', 'Metabolic activity of CYP2C19 and CYP3A4', 'CYP3A4 metabolic activity', 'metabolic ratios nor the ADP-induced platelet reactivity', 'marker of CYP2C19 metabolic activity', 'CYP2C19 and CYP3A4 Activity and ADP-induced Platelet Reactivity']","[{'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0050940', 'cui_str': 'lansoprazole'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C3714749', 'cui_str': ""S-Mephenytoin 4'-Hydroxylase""}]","[{'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C3714749', 'cui_str': ""S-Mephenytoin 4'-Hydroxylase""}, {'cui': 'C3714798', 'cui_str': 'CYP3A4'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0180576,"The treatment with amiodarone, a CYP3A4 inhibitor, influenced neither the metabolic ratios nor the ADP-induced platelet reactivity.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Máchal', 'Affiliation': ""International Clinical Research Center, St. Anne's University Hospital, Brno, Czech Republic.""}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Hlinomaz', 'Affiliation': ""International Clinical Research Center, St. Anne's University Hospital, Brno, Czech Republic.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kostolanská', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Peš', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Máchalová', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Šplíchal', 'Affiliation': 'Department of Pathophysiology, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': ""Mot'ovská"", 'Affiliation': 'Cardiocenter, Third Faculty of Medicine, Charles University and University Hospital, Prague, Czech Republic.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Juřica', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}]",Xenobiotica; the fate of foreign compounds in biological systems,['10.1080/00498254.2020.1731625']
339,31634245,Acoustic Shadowing Facilitates Ultrasound-guided Radial Artery Cannulation in Young Children.,"BACKGROUND


Arterial cannulation in young children can be challenging. Ultrasound guidance using focused acoustic shadowing may be suitable for guiding radial artery puncture in young children. The present research tested the hypothesis that ultrasound guidance using focused acoustic shadowing helps increase the success rate of radial artery cannulation in this population.
METHODS


In a double-blinded, parallel-group trial, 79 young children undergoing surgery under general anesthesia were randomly assigned to two groups (1:1 ratio): the traditional ultrasound group and the novel ultrasound group. Young children in the traditional group underwent conventional ultrasound-guided radial artery puncture, whereas those in the novel ultrasound group underwent radial artery puncture guided by acoustic shadowing ultrasound with double developing lines. All radial artery punctures were performed using the short-axis out-of-plane approach. The primary endpoint was the success rate of cannulation at the first attempt. The secondary endpoints included cannulation failure rate, ultrasound location time, and puncture time.
RESULTS


The success rate of cannulation at the first attempt in the novel ultrasound group (35 of 39 [90%]) was significantly higher than that in the traditional ultrasound group (24 of 40 [60%]; difference: 30% [95% CI, 12 to 48%], P =0.002). None of the patients in the ultrasound with acoustic shadowing group experienced failure of radial artery puncture and cannulation. The ultrasound location time and puncture time in the ultrasound acoustic shadowing group were significantly lower than that in the traditional ultrasound group (location time: median [interquartile range]: 6 [5, 8] vs. 18 [15, 21] s; puncture time: 24 [15, 41] vs. 40 [23, 56] s).
CONCLUSIONS


Acoustic shadowing via the use of double developing lines significantly improved the success rate of radial artery puncture in young children, compared with that achieved with the use of traditional ultrasound guidance.",2019,"The ultrasound location time and puncture time in the ultrasound acoustic shadowing group were significantly lower than that in the traditional ultrasound group (location time: median [interquartile range]: 6 [5, 8] vs. 18 [15, 21] s; puncture time: 24 [15, 41] vs. 40 [23, 56] s).
","['young children', 'Young Children', 'Young children', '79 young children undergoing surgery under general anesthesia']","['Acoustic Shadowing Facilitates Ultrasound-guided Radial Artery Cannulation', 'Ultrasound guidance using focused acoustic shadowing', 'conventional ultrasound-guided radial artery puncture', 'traditional ultrasound group and the novel ultrasound group', 'novel ultrasound group underwent radial artery puncture guided by acoustic shadowing ultrasound with double developing lines']","['cannulation failure rate, ultrasound location time, and puncture time', 'success rate of radial artery cannulation', 'success rate of radial artery puncture', 'failure of radial artery puncture and cannulation', 'success rate of cannulation', 'ultrasound location time and puncture time']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C1719833', 'cui_str': 'Acoustic shadowing'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure (procedure)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0332554', 'cui_str': 'Shadow (finding)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0162857', 'cui_str': 'Radial Artery'}]",79.0,0.097417,"The ultrasound location time and puncture time in the ultrasound acoustic shadowing group were significantly lower than that in the traditional ultrasound group (location time: median [interquartile range]: 6 [5, 8] vs. 18 [15, 21] s; puncture time: 24 [15, 41] vs. 40 [23, 56] s).
","[{'ForeName': 'ZheFeng', 'Initials': 'Z', 'LastName': 'Quan', 'Affiliation': 'From the Department of Anesthesiology, Beijing YouAn Hospital, Capital Medical University, Beijing, China (Z.Q., P.C., H.H.) Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China (L.Z., Y.L.) Department of Zoology and Physiology, University of Wyoming, Laramie, Wyoming (C.Z.).'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Chi', 'Affiliation': ''}, {'ForeName': 'HaiLi', 'Initials': 'H', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000002948']
340,31905348,Study of the beneficial role of exhaled nitric oxide in combination with GINA guidelines for titration of inhaled corticosteroids in children with asthma.,"BACKGROUND


The use of FE NO  in association with current guidelines in the treatment of asthma has not been studied thoroughly. This study aimed to evaluate the beneficial role of FE NO  in combination with GINA (Global Initiative for Asthma) guidelines for titration of inhaled corticosteroids (ICS) in asthmatic children.
METHODS


It was a prospective and descriptive study. Uncontrolled asthmatic children were randomized to two groups: group 1 (followed GINA guidelines) or group 2 (followed GINA guidelines + FE NO  modification for ICS titration). The two groups were followed-up for 12 months.
RESULTS


The mean age of the patients in the study was 10 ± 4 years for group 1 (n = 116) and 11 ± 5 years for group 2 (n = 108). There were 87.9% patients in group 1 and 82.4% in group 2 that had a familial allergic history. There were 58.6% of moderate asthma and 41.4% of severe asthma in group 1, versus 56.4% and 43.6% in group 2, respectively. The percentage of moderate and severe asthma was also significantly modified after 6th and 12th month versus at inclusion (43.1% and 35.3% versus 58.6%, P < 0.01 and P < 0.005; 23.2% and 12.9% versus 41.4%, P < 0.005 and P < 0.001, respectively). The total daily dose of ICS in group 2 at 12th months was significantly lower than that in group 1 (3515 ± 1175 versus 4785 ± 1235 mcg; P < 0.005). The daily cost of ICS treatment in group 2 was also lower than that of group 1 (18 ± 4 versus 27 ± 3 USD; P < 0.05).
CONCLUSION


The use of FE NO  in combination with GINA guidelines for ICS titration is useful in reducing the daily ICS dose and treatment cost.",2020,There was 87.9% patients in group 1 and 82.4% in group 2 had a familial allergic history.,"['asthmatic children', 'The mean age of study patients was 10±4 years for group 1 (n=116) and 11±5 years for group 2 (n=108', 'Uncontrolled asthmatic children', 'children with asthma']","['ICS', 'FENO in combination with GINA (Global Initiative', 'FENO', 'group 1 (followed GINA guidelines) or group 2 (followed GINA guidelines + FENO modification for ICS titration', 'inhaled corticosteroids (ICS']","['familial allergic history', 'daily cost of ICS treatment', 'severe asthma', 'percentage of moderate and severe asthma']","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}]","[{'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}]","[{'cui': 'C1611743', 'cui_str': 'Familial (FPAH)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]",,0.0282384,There was 87.9% patients in group 1 and 82.4% in group 2 had a familial allergic history.,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Dinh-Thi-Dieu', 'Affiliation': 'Hai Duong Medical Technical University. Hai Duong, Vietnam.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vo-Thi-Kim', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tran-Van', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Tang-Thi-Thao', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Duong-Quy', 'Affiliation': ''}]",Journal of breath research,['10.1088/1752-7163/ab6809']
341,32216778,Gingivitis efficacy of a 0.454% w/w stannous fluoride dentifrice: a 24-week randomized controlled trial.,"BACKGROUND


Plaque-induced gingivitis can be prevented and treated with regular effective oral hygiene, principally via mechanical cleaning with regular toothbrushing. To complement the mechanical plaque removal, antimicrobial ingredients can be incorporated into dentifrices to inhibit the growth of plaque. This study aimed to evaluate and compare gingivitis and the proportion of subjects moving between gingivitis severity (< 10, > 10 < 30, > 30% bleeding sites), and plaque reduction, following twice daily use of an experimental non-aqueous 0.454% weight/weight (w/w) stannous fluoride (SnF 2 ) dentifrice, compared to a negative control dentifrice over 12 and 24 weeks.
METHOD


This was a single-center, examiner-blinded, randomized, stratified, two-treatment arm, parallel group, 24-week clinical study in healthy adult volunteers with moderate gingivitis. At baseline, after abstaining from toothbrushing overnight, subjects underwent MGI (modified gingival index), BI (bleeding index) and PI (plaque index) assessments. Eligible subjects, who met the inclusion/exclusion criteria, were stratified based on gender and baseline mean MGI score (Low ≤2.00 /High > 2.00) and randomized to treatment. Following randomization, subjects underwent a thorough dental prophylaxis and flossing. After 12 and 24 weeks of twice daily brushing with their allocated treatment, subjects returned to the site (with overnight plaque, having abstained from oral hygiene procedures for 8 h prior to visit) for MGI, BI and PI assessments. Treatment effect was evaluated by comparing the MGI, BI and PI scores.
RESULTS


One hundred and twenty-nine subjects were screened; 98 subjects were randomized and 90 subjects completed the study. Statistically significant differences between treatments, in favour of the 0.454% stannous fluoride dentifrice were observed, compared to the negative control dentifrice, for all outcome measures (MGI, BI, bleeding sites and PI at weeks 12 and 24 p < 0.0001). At 24 weeks, 71% of subjects in the 0.453% SnF 2  treatment group demonstrated < 10% of bleeding sites.
CONCLUSION


A dentifrice containing 0.454% w/w SnF 2  was shown to be superior to a standard dentifrice in controlling gingivitis and supra-gingival plaque, over a 24-week period. Over two thirds of subjects in the 0.454% SnF 2  treatment group demonstrated a level of bleeding sites potentially representative of ""clinical periodontal health"" (< 10%) following a dental prophylaxis and 24 weeks of product use.
TRIAL REGISTRATION


This study was retrospectively registered at ClinicalTrials.gov, on 11th Oct. 2019 (NCT04123665).",2020,"Statistically significant differences between treatments, in favour of the 0.454% stannous fluoride dentifrice were observed, compared to the negative control dentifrice, for all outcome measures (MGI, BI, bleeding sites and PI at weeks 12 and 24 p < 0.0001).","['healthy adult volunteers with moderate gingivitis', 'One hundred and twenty-nine subjects were screened; 98 subjects were randomized and 90 subjects completed the study', 'subjects moving between gingivitis severity (<\u200910, >\u200910\u2009<\u200930, >\u200930% bleeding sites), and plaque reduction, following twice daily use of an experimental non-aqueous 0.454% weight/weight (w/w', 'Eligible subjects, who met the inclusion/exclusion criteria, were stratified based on gender and baseline mean MGI score (Low ≤2.00 /High']","['stannous fluoride (SnF 2 ) dentifrice, compared to a negative control dentifrice', 'stannous fluoride dentifrice']","['bleeding sites', 'level of bleeding sites potentially representative of ""clinical periodontal health', 'MGI (modified gingival index), BI (bleeding index) and PI (plaque index) assessments', 'MGI, BI and PI scores', 'outcome measures (MGI, BI, bleeding sites and PI', 'Gingivitis efficacy']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C4075412', 'cui_str': 'Moderate gingivitis (disorder)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0578671', 'cui_str': 'Does move (finding)'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C2919747', 'cui_str': 'Weight/weight ratio'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0038143', 'cui_str': 'Stannous Fluoride'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0017569', 'cui_str': 'Gingival Index'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}]",98.0,0.0264049,"Statistically significant differences between treatments, in favour of the 0.454% stannous fluoride dentifrice were observed, compared to the negative control dentifrice, for all outcome measures (MGI, BI, bleeding sites and PI at weeks 12 and 24 p < 0.0001).","[{'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Parkinson', 'Affiliation': 'GlaxoSmithKline Consumer Healthcare, Weybridge, KT13 0DE, UK. charles.x.parkinson@gsk.com.'}, {'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Milleman', 'Affiliation': 'Salus Research, Inc., Fort Wayne, IN, USA.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Milleman', 'Affiliation': 'Salus Research, Inc., Fort Wayne, IN, USA.'}]",BMC oral health,['10.1186/s12903-020-01079-6']
342,32227771,Efficacy and safety of Yiqi Huoxue Jiedu decoction for the treatment of advanced epithelial ovarian cancer patients: a double-blind randomized controlled clinical trial.,"OBJECTIVE


To further evaluate the complementary effect of Yiqi Huoxue Jiedu decoction (YHJD) on patients with advanced epithelial ovarian cancer (EOC).
METHODS


All 330 enrolled participants diagnosed with stage Ⅲc EOC were randomly divided into two groups that received YHJD or a placebo. The primary end point was health-related quality of life (HRQL) measured by the functional assessment of cancer therapy-ovary cancer (FACT-O) questionnaire. The secondary end point was progression-free survival (PFS).
RESULTS


A total of 299 participants completed the trial with 153 and 146 in YHJD and control groups, respectively. After 6 months of treatment, YHJD increased physical wellbeing (PWB), functional wellbeing (FWB), additional concerns (AC), and the trial outcome index (TOI) (P < 0.05) by various degrees compared with the baseline. YHJD also had notable advantages over the placebo at 3 and 6 months in terms of PWB, FWB, AC (P < 0.05), and TOI (P < 0.01). In addition, YHJD had a significant advantage in terms of PFS compared with the placebo (21 vs 18 months, P < 0.05). No adverse events were reported.
CONCLUSION


YHJD is an effective and safe choice as a complementary therapy to improve HRQL and prolong PFS of stage Ⅲc EOC patients.",2020,"After 6 months of treatment, YHJD increased physical wellbeing (PWB), functional wellbeing (FWB), additional concerns (AC), and the trial outcome index (TOI) (P < 0.05) by various degrees compared with the baseline.","['advanced epithelial ovarian cancer patients', '299 participants completed the trial with 153 and 146 in YHJD and control groups, respectively', 'patients with advanced epithelial ovarian cancer (EOC', 'All 330 enrolled participants diagnosed with stage Ⅲc EOC']","['placebo', 'Yiqi Huoxue Jiedu decoction (YHJD', 'YHJD', 'Yiqi Huoxue Jiedu decoction', 'YHJD or a placebo']","['health-related quality of life (HRQL', 'functional assessment of cancer therapy-ovary cancer (FACT-O) questionnaire', 'adverse events', 'PFS', 'YHJD increased physical wellbeing (PWB), functional wellbeing (FWB), additional concerns (AC), and the trial outcome index (TOI', 'Efficacy and safety', 'progression-free survival (PFS']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0078696', 'cui_str': 'Yiqi Huoxue'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",330.0,0.436796,"After 6 months of treatment, YHJD increased physical wellbeing (PWB), functional wellbeing (FWB), additional concerns (AC), and the trial outcome index (TOI) (P < 0.05) by various degrees compared with the baseline.","[{'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Bifa', 'Initials': 'B', 'LastName': 'Fan', 'Affiliation': 'Department of Pain, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Yitong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Juling', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': ""Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Xinxing', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Graduate School, Beijing University of Chinese Medicine, Beijing 100029, China.'}, {'ForeName': 'Wenping', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': ""Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
343,32227772,Effectiveness of Xinglou Chengqi decoction on constipation in patients with acute ischemic stroke: a randomized controlled trial.,"OBJECTIVE


To evaluate the effectiveness of traditional Chinese herbal Xinglouchengqi (XLCQ) decoction for the treatment of constipation in acute ischemic stroke patients, and figure out the role that bowel movements play in the treatment of acute ischemic stroke.
METHODS


A total of 317 eligible patients were recruited and randomized to the XLCQ group (211 patients) or the control group (106 patients). In addition to conventional standard medical care and rehabilitation, participants in the XLCQ group received XLCQ decoction, while the control group received clysis therapy using glycerin enemas or lactulose oral solution. Both groups were given treatment for 3 to 6 d, during which they received daily visits to record defecation features and accompanying symptoms. Neurological assessments using the National Institutes of Health Stroke Scale (NIHSS) were conducted before and 1 month after treatment.
RESULTS


Patients in the XLCQ group had lower aggregate constipation scores compared with the control group on days 3 and 5 (P < 0.05). Spontaneous bowel movements tended to reappear more rapidly after taking the XLCQ decoction than after conventional laxative treatment. Both the average aggregate constipation score and the time taken to achieve spontaneous bowel movements showed positive correlations with NIHSS scores before and 1 month after treatment (P < 0.01).
CONCLUSION


Treatment with XLCQ decoction effectively alleviated the overall symptoms of constipation in acute ischemic stroke patients. The status of bowel movements in acute ischemic stroke can reflect the severity of neurological impairment and predict neurological outcomes at 1 month.",2020,"RESULTS


Patients in the XLCQ group had lower aggregate constipation scores compared with the control group on days 3 and 5 (P < 0.05).","['group (211 patients) or the control group (106 patients', 'patients with acute ischemic stroke', '317 eligible patients', 'acute ischemic stroke patients']","['traditional Chinese herbal Xinglouchengqi (XLCQ) decoction', 'clysis therapy using glycerin enemas or lactulose oral solution', 'XLCQ', 'XLCQ decoction', 'Xinglou Chengqi decoction']","['Spontaneous bowel movements', 'Health Stroke Scale (NIHSS', 'average aggregate constipation score', 'constipation', 'NIHSS scores', 'overall symptoms of constipation', 'aggregate constipation scores']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0376667', 'cui_str': 'Herbal'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C1252332', 'cui_str': 'Lactulose Oral Solution'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0205418', 'cui_str': 'Aggregate (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",317.0,0.0483157,"RESULTS


Patients in the XLCQ group had lower aggregate constipation scores compared with the control group on days 3 and 5 (P < 0.05).","[{'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing 100700, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Neurology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing 100700, China.'}, {'ForeName': 'Hualei', 'Initials': 'H', 'LastName': 'Geng', 'Affiliation': 'Department of Neurology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing 100700, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Department of Neurology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing 100700, China.'}, {'ForeName': 'Yinping', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology, Beijing Pinggu Hospital of Traditional Chinese Medicine, Beijing 101200, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Beijing Changping Hospital of Traditional Chinese Medicine, Beijing 102200, China.'}, {'ForeName': 'Jinbin', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Neurology, Hospital affiliated to Changzhi Academy of Chinese Medical Sciences, Changzhi 046000, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing 100700, China.'}, {'ForeName': 'Yahui', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing 100700, China.'}, {'ForeName': 'Ruyu', 'Initials': 'R', 'LastName': 'Yan', 'Affiliation': 'Department of Neurology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing 100700, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': 'Department of Neurology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing 100700, China.'}, {'ForeName': 'Yihuai', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'Department of Neurology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing 100700, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
344,32227773,"Effectiveness of electroacupuncture at Jiaji acupoints (EX-B2), plus moxibustion and intermediate on postherpetic neuralgia: a randomized controlled trial.","OBJECTIVE


To investigate the effectiveness of electroacupuncture at Jiaji acupoints (EX-B 2) plus moxibustion and intermediate frequency on postherpetic neuralgia (PHN).
METHODS


A total of 140 outpatients who satisfied the inclusion criteria and volunteered for this treatment were randomly divided into treatment (n = 70) and control (n = 70) groups. Both groups received a localized lesion area and electroacupuncture treatment combined with moxibustion and intermediate frequency. The treatment group (TG) increased acupuncture at Jiaji acupoints (EX-B 2) and electroacupuncture. Pain and anxiety were assessed before and after 5, 10, 15, and 20 treatments by using visual pain simulation score (VAS) and Hamilton anxiety scale (HAMA), respectively. Clinical efficacy was also evaluated.
RESULTS


The baseline between the two groups did not significantly differ (P > 0.05). The VAS and HAMA scores of the two groups after treatment significantly decreased compared with those of various treatment stages (P > 0.05). The HAMA score (P < 0.01) of TG was lower than that of the control group (CG). The VAS score of TG was lower than that of CG in the 5th and 10th treatments (P < 0.01). In the 15th and 10th scores, CG was also superior to TG (P < 0.05).
CONCLUSION


The combined treatment of electroacupuncture at Jiaji acupoints (EX-B 2), moxibustion, and intermediate frequency can relieve the pain and anxiety symptoms of PHN. The efficacy of the combined treatment was superior to traditional acupuncture.",2020,The HAMA score (P < 0.01) of TG was lower than that of the control group (CG).,"['postherpetic neuralgia', '140 outpatients who satisfied the inclusion criteria and volunteered for this treatment']","['acupuncture at Jiaji acupoints (EX-B 2) and electroacupuncture', 'electroacupuncture at Jiaji acupoints (EX-B 2), moxibustion, and intermediate frequency', 'localized lesion area and electroacupuncture treatment combined with moxibustion and intermediate frequency', 'electroacupuncture at Jiaji acupoints (EX-B 2) plus moxibustion', 'electroacupuncture at Jiaji acupoints (EX-B2), plus moxibustion and intermediate']","['HAMA score', 'visual pain simulation score (VAS) and Hamilton anxiety scale (HAMA', 'VAS score of TG', 'Clinical efficacy', 'pain and anxiety symptoms of PHN', 'VAS and HAMA scores', 'Pain and anxiety']","[{'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia (disorder)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C0045550', 'cui_str': 'sodium 2,5-dichloro-4-bromophenol'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0026652', 'cui_str': 'Moxabustion'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",140.0,0.0252876,The HAMA score (P < 0.01) of TG was lower than that of the control group (CG).,"[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Health and Rehabilitation College, Chengdu University of Traditional Chinese Medicine, Chengdu 610000, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Qiu', 'Affiliation': ""Department of Pain, Chengdu First People's Hospital, Chengdu 610000, China.""}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': ""Department of Pain, Chengdu First People's Hospital, Chengdu 610000, China.""}, {'ForeName': 'Jianbing', 'Initials': 'J', 'LastName': 'Ouyang', 'Affiliation': ""Department of Pain, Chengdu First People's Hospital, Chengdu 610000, China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Department of Pain, Chengdu First People's Hospital, Chengdu 610000, China.""}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'He', 'Affiliation': ""Department of Pain, Chengdu First People's Hospital, Chengdu 610000, China.""}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Zeng', 'Affiliation': ""Department of Pain, Chengdu First People's Hospital, Chengdu 610000, China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': ""Department of Pain, Chengdu First People's Hospital, Chengdu 610000, China.""}, {'ForeName': 'Jinlin', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': 'Department of infectious,the First Affiliated Hospital of Guangxi Medical University, Nanning 530021, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
345,30852257,Fear extinction learning as a predictor of response to cognitive behavioral therapy for pediatric obsessive compulsive disorder.,"BACKGROUND


While cognitive behavior therapy (CBT) is an effective treatment for many children and adolescents with Obsessive Compulsive Disorder (OCD), therapeutic response is variable. Fear conditioning and extinction are central constructs underlying exposure-based CBT. Fear extinction learning assessed prior to CBT may be a useful predictor of CBT response for guiding treatment decisions.
METHODS


Sixty-four youth who participated in a randomized placebo-controlled trial of CBT with and without d-cycloserine (DCS) completed a fear conditioning task. Skin conductance response (SCR) scores were used to measure fear acquisition and extinction to determine whether extinction learning could predict CBT response.
RESULTS


CBT responders and non-responders appeared to acquire conditioned fear SCRs in a similar manner. However, differences between treatment responders and non-responders emerged during the extinction phase. A responder (responder, non-responder) by conditioned stimulus type (CS+, CS-) interaction showed that CBT responders differentiated the stimulus paired with (CS+) and without (CS-) the unconditioned stimulus correctly during early and late extinction, whereas the CBT non-responders did not (p = .004).
CONCLUSIONS


While the small sample size makes conclusions tentative, this study supports an emerging literature that differential fear extinction may be an important factor underlying clinical correlates of pediatric OCD, including CBT response.",2019,"RESULTS


CBT responders and non-responders appeared to acquire conditioned fear SCRs in a similar manner.","['pediatric obsessive compulsive disorder', 'many children and adolescents with Obsessive Compulsive Disorder (OCD', 'Sixty-four youth who participated in a randomized']","['CBT with and without d-cycloserine (DCS) completed a fear conditioning task', 'placebo', 'cognitive behavioral therapy', 'cognitive behavior therapy (CBT', 'Fear extinction learning']","['CBT response', 'Skin conductance response (SCR) scores']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0087178', 'cui_str': 'Youth'}]","[{'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",64.0,0.0311835,"RESULTS


CBT responders and non-responders appeared to acquire conditioned fear SCRs in a similar manner.","[{'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Geller', 'Affiliation': 'Massachusetts General Hospital, 185 Cambridge Street, Suite 2000, Boston, MA, 02114, United States; Harvard University Medical School, Boston, MA, United States. Electronic address: dan.geller@mgh.harvard.edu.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'McGuire', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Johns Hopkins University School of Medicine, Baltimore, MD, United States. Electronic address: jfmcguire@jhmi.edu.'}, {'ForeName': 'Scott P', 'Initials': 'SP', 'LastName': 'Orr', 'Affiliation': 'Massachusetts General Hospital, 185 Cambridge Street, Suite 2000, Boston, MA, 02114, United States; Harvard University Medical School, Boston, MA, United States. Electronic address: scott_orr@hms.harvard.edu.'}, {'ForeName': 'Brent J', 'Initials': 'BJ', 'LastName': 'Small', 'Affiliation': 'School of Aging Studies, University of South Florida, 13301 Bruce B Downs Blvd, Tampa, FL, 33620, United States. Electronic address: bsmall@usf.edu.'}, {'ForeName': 'Tanya K', 'Initials': 'TK', 'LastName': 'Murphy', 'Affiliation': 'Department of Pediatrics, University of South Florida, Rothman Center for Neuropsychiatry, United States; Department of Psychiatry & Behavioral Neurosciences, University of South Florida, United States.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Trainor', 'Affiliation': 'Massachusetts General Hospital, 185 Cambridge Street, Suite 2000, Boston, MA, 02114, United States. Electronic address: kbtrainor@mgh.harvard.edu.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Porth', 'Affiliation': 'Massachusetts General Hospital, 185 Cambridge Street, Suite 2000, Boston, MA, 02114, United States. Electronic address: rporth@mgh.harvard.edu.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Wilhelm', 'Affiliation': 'Massachusetts General Hospital, 185 Cambridge Street, Suite 2000, Boston, MA, 02114, United States; Harvard University Medical School, Boston, MA, United States. Electronic address: swilhelm@mgh.harvard.edu.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Storch', 'Affiliation': 'Menninger Department of Psychiatry & Behavioral Sciences, Baylor College of Medicine, 1977 Butler Blvd, Suite 400, Houston 77030, TX, United States. Electronic address: Eric.Storch@bcm.edu.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2019.02.005']
346,32203971,Interactive Motion-Assisted Exposure Therapy for Veterans with Treatment-Resistant Posttraumatic Stress Disorder: A Randomized Controlled Trial.,"BACKGROUND


Veterans with posttraumatic stress disorder (PTSD) tend to benefit less from evidence-based treatments than other PTSD populations. A novel virtual reality and motion-assisted exposure therapy, called 3MDR, provides treatment in an immersive, personalized and activating context.
OBJECTIVE


To study the efficacy of 3MDR for veterans with treatment-resistant PTSD.
METHOD


In a randomized controlled trial (n = 43) 3MDR was compared to a non-specific treatment component control group. Primary outcome was clinician-rated PTSD symptoms at baseline, after 3MDR, and at the 12-week and 16-week follow-up (primary end point). Intention-to-treat analyses of covariance and mixed models were applied to study differences between groups at the end point and over the course of intervention, controlling for baseline scores.
RESULTS


The decrease in PTSD symptom severity from baseline to end point was significantly greater for 3MDR as compared to the control group, with a large effect size (F[1, 37] = 6.43, p = 0.016, d = 0.83). No significant between-group difference was detected in the course of PTSD symptoms during treatment when including all time points. The dropout rate was low (7%), and 45% of the patients in the 3MDR group improved clinically. The number needed to treat was 2.86.
CONCLUSIONS


In this trial, 3MDR significantly decreased PTSD symptoms in veterans with, on average, a history of 4 unsuccessful treatments. The low dropout rate may be indicative of high engagement. However, a lack of significant differences on secondary outcomes limits conclusions that can be drawn on its efficacy and underlines the need for larger phase III trials. These data show emerging evidence for 3MDR and its potential to progress PTSD treatment for veterans (Dutch Trial Register Identifier: NL5126).",2020,"The decrease in PTSD symptom severity from baseline to end point was significantly greater for 3MDR as compared to the control group, with a large effect size (F[1, 37] = 6.43, p = 0.016, d = 0.83).","['Veterans with Treatment-Resistant Posttraumatic Stress Disorder', 'veterans with treatment-resistant PTSD', 'n = 43', 'Veterans with posttraumatic stress disorder (PTSD']","['Interactive Motion-Assisted Exposure Therapy', '3MDR']","['PTSD symptoms', 'PTSD symptom severity', 'dropout rate', 'course of PTSD symptoms', '3MDR', 'clinician-rated PTSD symptoms']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}]",,0.0316866,"The decrease in PTSD symptom severity from baseline to end point was significantly greater for 3MDR as compared to the control group, with a large effect size (F[1, 37] = 6.43, p = 0.016, d = 0.83).","[{'ForeName': 'Marieke J', 'Initials': 'MJ', 'LastName': 'van Gelderen', 'Affiliation': ""ARQ Centrum'45, Diemen, The Netherlands, m.van.gelderen@centrum45.nl.""}, {'ForeName': 'Mirjam J', 'Initials': 'MJ', 'LastName': 'Nijdam', 'Affiliation': ""ARQ Centrum'45, Diemen, The Netherlands.""}, {'ForeName': 'Joris F G', 'Initials': 'JFG', 'LastName': 'Haagen', 'Affiliation': 'ARQ Centre of Expertise Impact, Diemen, The Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vermetten', 'Affiliation': 'Department of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.'}]",Psychotherapy and psychosomatics,['10.1159/000505977']
347,30705390,Screening and brief intervention for obesity in primary care: cost-effectiveness analysis in the BWeL trial.,"BACKGROUND


The Brief Intervention for Weight Loss Trial enrolled 1882 consecutively attending primary care patients who were obese and participants were randomised to physicians opportunistically endorsing, offering, and facilitating a referral to a weight loss programme (support) or recommending weight loss (advice). After one year, the support group lost 1.4 kg more (95%CI 0.9 to 2.0): 2.4 kg versus 1.0 kg. We use a cohort simulation to predict effects on disease incidence, quality of life, and healthcare costs over 20 years.
METHODS


Randomly sampling from the trial population, we created a virtual cohort of 20 million adults and assigned baseline morbidity. We applied the weight loss observed in the trial and assumed weight regain over four years. Using epidemiological data, we assigned the incidence of 12 weight-related diseases depending on baseline disease status, age, gender, body mass index. From a healthcare perspective, we calculated the quality adjusted life years (QALYs) accruing and calculated the incremental difference between trial arms in costs expended in delivering the intervention and healthcare costs accruing. We discounted future costs and benefits at 1.5% over 20 years.
RESULTS


Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease. The incremental cost of support over advice was £2.01million/100,000. However, the support intervention reduced health service costs by £5.86 million/100,000 leading to a net saving of £3.85 million/100,000. The support intervention produced 992 QALYs/100,000 people relative to advice.
CONCLUSIONS


A brief intervention in which physicians opportunistically endorse, offer, and facilitate a referral to a behavioural weight management service to patients with a BMI of at least 30 kg/m 2  reduces healthcare costs and improves health more than advising weight loss.",2019,"Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease.","['Randomly sampling from the trial population, we created a virtual cohort of 20 million adults and assigned baseline morbidity', 'patients with a BMI of at least 30\u2009kg/m 2  reduces healthcare costs and improves health more than advising weight loss', '1882 consecutively attending primary care patients who were obese and participants']","['physicians opportunistically endorsing, offering, and facilitating a referral to a weight loss programme (support) or recommending weight loss (advice']","['disease incidence, quality of life, and healthcare costs', 'cumulative incidence of weight-related disease', 'weight loss', 'health service costs']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0034380'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",1882.0,0.159942,"Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease.","[{'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Retat', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pimpin', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Webber', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Abbygail', 'Initials': 'A', 'LastName': 'Jaccard', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lewis', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tearne', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Christian-Brown', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Peymane', 'Initials': 'P', 'LastName': 'Adab', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Begh', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jolly', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Daley', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Ashby Road, Loughborough, Leicestershire, LE11 3TU, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farley', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Lycett', 'Affiliation': 'Faculty of Health and Life Sciences, Coventry University, Priory Street, Coventry, CV1 5FB, UK.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Nickless', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Ly-Mee', 'Initials': 'LM', 'LastName': 'Yu', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK. paul.aveyard@phc.ox.ac.uk.'}]",International journal of obesity (2005),['10.1038/s41366-018-0295-7']
348,30924492,"Maternal and Infant Bone Mineral Density 1 Year After Delivery in a Randomized, Controlled Trial of Maternal Tenofovir Disoproxil Fumarate to Prevent Mother-to-child Transmission of Hepatitis B Virus.","In a randomized, double-blind, placebo-controlled trial of tenofovir disoproxil fumarate (TDF) use from 28 weeks gestational age to 2 months postpartum to prevent mother-to-child transmission of hepatitis B virus, there was no significant effect of maternal TDF use on maternal or infant bone mineral density 1 year after delivery/birth. Clinical Trials Registration. NCT01745822.",2019,"In a randomized, double-blind, placebo-controlled trial of tenofovir disoproxil fumarate (TDF) use from 28 weeks gestational age to 2 months postpartum to prevent mother-to-child transmission of hepatitis B virus, there was no significant effect of maternal TDF use on maternal or infant bone mineral density 1 year after delivery/birth.","['28 weeks gestational age to 2 months postpartum to prevent mother-to-child transmission of hepatitis B virus', 'Mother-to-child Transmission of Hepatitis B Virus']","['Maternal Tenofovir Disoproxil Fumarate', 'tenofovir disoproxil fumarate (TDF', 'placebo']",['Maternal and Infant Bone Mineral Density 1 Year'],"[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0282474', 'cui_str': 'Mother-to-Child Transmission'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",,0.40767,"In a randomized, double-blind, placebo-controlled trial of tenofovir disoproxil fumarate (TDF) use from 28 weeks gestational age to 2 months postpartum to prevent mother-to-child transmission of hepatitis B virus, there was no significant effect of maternal TDF use on maternal or infant bone mineral density 1 year after delivery/birth.","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Salvadori', 'Affiliation': 'Institut de Recherche pour le Développement (IRD)-PHPT, Chiang Mai University, Thailand.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Fan', 'Affiliation': 'Department of Radiology and Biomedical Imaging, University of California-San Francisco.'}, {'ForeName': 'Waralee', 'Initials': 'W', 'LastName': 'Teeyasoontranon', 'Affiliation': 'Department of Radiology, Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University, Thailand.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ngo-Giang-Huong', 'Affiliation': 'Institut de Recherche pour le Développement (IRD)-PHPT, Chiang Mai University, Thailand.'}, {'ForeName': 'Siriluk', 'Initials': 'S', 'LastName': 'Phanomcheong', 'Affiliation': 'Banglamung Hospital, Chon Buri.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Luvira', 'Affiliation': 'Nopparat Rajathanee Hospital, Bangkok.'}, {'ForeName': 'Achara', 'Initials': 'A', 'LastName': 'Puangsombat', 'Affiliation': 'Samutprakarn Hospital, Samut Prakan.'}, {'ForeName': 'Arunrat', 'Initials': 'A', 'LastName': 'Suwannarat', 'Affiliation': 'Nakornping Hospital, Chiang Mai.'}, {'ForeName': 'Ussanee', 'Initials': 'U', 'LastName': 'Srirompotong', 'Affiliation': 'Khon Kaen Hospital, Thailand.'}, {'ForeName': 'Chaiwat', 'Initials': 'C', 'LastName': 'Putiyanun', 'Affiliation': 'Chiang Kham Hospital, Thailand.'}, {'ForeName': 'Tim R', 'Initials': 'TR', 'LastName': 'Cressey', 'Affiliation': 'Institut de Recherche pour le Développement (IRD)-PHPT, Chiang Mai University, Thailand.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Decker', 'Affiliation': 'Institut de Recherche pour le Développement (IRD)-PHPT, Chiang Mai University, Thailand.'}, {'ForeName': 'Woottichai', 'Initials': 'W', 'LastName': 'Khamduang', 'Affiliation': 'Faculty of Associated Medical Sciences, Chiang Mai University, Thailand.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Harrison', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Camlin', 'Initials': 'C', 'LastName': 'Tierney', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Shepherd', 'Affiliation': 'Department of Radiology and Biomedical Imaging, University of California-San Francisco.'}, {'ForeName': 'Athena P', 'Initials': 'AP', 'LastName': 'Kourtis', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bulterys', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'George K', 'Initials': 'GK', 'LastName': 'Siberry', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Gonzague', 'Initials': 'G', 'LastName': 'Jourdain', 'Affiliation': 'Institut de Recherche pour le Développement (IRD)-PHPT, Chiang Mai University, Thailand.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy982']
349,31403974,Upper Airway Collapsibility during Dexmedetomidine and Propofol Sedation in Healthy Volunteers: A Nonblinded Randomized Crossover Study.,"BACKGROUND


Dexmedetomidine is a sedative promoted as having minimal impact on ventilatory drive or upper airway muscle activity. However, a trial recently demonstrated impaired ventilatory drive and induction of apneas in sedated volunteers. The present study measured upper airway collapsibility during dexmedetomidine sedation and related it to propofol.
METHODS


Twelve volunteers (seven female) entered this nonblinded, randomized crossover study. Upper airway collapsibility (pharyngeal critical pressure) was measured during low and moderate infusion rates of propofol or dexmedetomidine. A bolus dose was followed by low (0.5 μg · kg · h or 42 μg · kg · min) and moderate (1.5 μg · kg · h or 83 μg · kg · min) rates of infusion of dexmedetomidine and propofol, respectively.
RESULTS


Complete data sets were obtained from nine volunteers (median age [range], 46 [23 to 66] yr; body mass index, 25.4 [20.3 to 32.4] kg/m). The Bispectral Index score at time of pharyngeal critical pressure measurements was 74 ± 10 and 65 ± 13 (mean difference, 9; 95% CI, 3 to 16; P = 0.011) during low infusion rates versus 57 ± 16 and 39 ± 12 (mean difference, 18; 95% CI, 8 to 28; P = 0.003) during moderate infusion rates of dexmedetomidine and propofol, respectively. A difference in pharyngeal critical pressure during sedation with dexmedetomidine or propofol could not be shown at either the low or moderate infusion rate. Median (interquartile range) pharyngeal critical pressure was -2.0 (less than -15 to 2.3) and 0.9 (less than -15 to 1.5) cm H2O (mean difference, 0.9; 95% CI, -4.7 to 3.1) during low infusion rates (P = 0. 595) versus 0.3 (-9.2 to 1.4) and -0.6 (-7.7 to 1.3) cm H2O (mean difference, 0.0; 95% CI, -2.1 to 2.1; P = 0.980) during moderate infusion of dexmedetomidine and propofol, respectively. A strong linear relationship between pharyngeal critical pressure during dexmedetomidine and propofol sedation was evident at low (r = 0.82; P = 0.007) and moderate (r = 0.90; P < 0.001) infusion rates.
CONCLUSIONS


These observations suggest that dexmedetomidine sedation does not inherently protect against upper airway obstruction.",2019,"A strong linear relationship between pharyngeal critical pressure during dexmedetomidine and propofol sedation was evident at low (r = 0.82; P = 0.007) and moderate (r = 0.90; P < 0.001) infusion rates.
","['Twelve volunteers (seven female', 'sedated volunteers', 'Healthy Volunteers', 'nine volunteers (median age [range], 46 [23 to 66] yr; body mass index, 25.4 [20.3 to 32.4] kg/m']","['dexmedetomidine and propofol, respectively', 'dexmedetomidine or propofol', 'Dexmedetomidine', 'dexmedetomidine', 'Dexmedetomidine and Propofol Sedation', 'propofol or dexmedetomidine', 'dexmedetomidine sedation']","['Median (interquartile range) pharyngeal critical pressure', 'pharyngeal critical pressure', 'ventilatory drive and induction of apneas', 'Bispectral Index score at time of pharyngeal critical pressure measurements', 'Upper airway collapsibility (pharyngeal critical pressure']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517709', 'cui_str': '32.4 (qualifier value)'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0231932', 'cui_str': 'Ventilatory drive, function (observable entity)'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}]",12.0,0.141975,"A strong linear relationship between pharyngeal critical pressure during dexmedetomidine and propofol sedation was evident at low (r = 0.82; P = 0.007) and moderate (r = 0.90; P < 0.001) infusion rates.
","[{'ForeName': 'Åse', 'Initials': 'Å', 'LastName': 'Lodenius', 'Affiliation': 'From the Function Perioperative Medicine and Intensive Care, Karolinska University Hospital, and the Department of Physiology and Pharmacology, Section for Anesthesiology and Intensive Care, Karolinska Institutet, Stockholm, Sweden (A.L., L.I.E., M.J.F.) the West Australian Sleep Disorders Research Institute, Department of Pulmonary Physiology and Sleep Medicine, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia (K.J.M., P.R.E., D.R.H., J.H.W.) the Centre for Sleep Science, School of Human Sciences (K.J.M., P.R.E., D.R.H., J.H.W.) the Department of Anaesthesia, Sir Charles Gairdner Hospital (B.K.L.), Nedlands, Western Australia, Australia the Institute of Biomedicine, University of Turku, and Unit of Clinical Pharmacology, Turku University Hospital, Turku, Finland (M.S.).'}, {'ForeName': 'Kathleen J', 'Initials': 'KJ', 'LastName': 'Maddison', 'Affiliation': ''}, {'ForeName': 'Brad K', 'Initials': 'BK', 'LastName': 'Lawther', 'Affiliation': ''}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Scheinin', 'Affiliation': ''}, {'ForeName': 'Lars I', 'Initials': 'LI', 'LastName': 'Eriksson', 'Affiliation': ''}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Eastwood', 'Affiliation': ''}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Hillman', 'Affiliation': ''}, {'ForeName': 'Malin Jonsson', 'Initials': 'MJ', 'LastName': 'Fagerlund', 'Affiliation': ''}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Walsh', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000002883']
350,30641350,Sex differences in response to ketamine as a rapidly acting intervention for treatment resistant depression.,"BACKGROUND


While ketamine has been increasingly studied for treatment resistant depression (TRD), the impact of sex differences on treatment outcomes has not been well studied. The objective was to ascertain whether there were differences in response to a single administration of ketamine for TRD between men and women, and between pre- and post-menopausal women.
METHODS


A randomized, double-blind, placebo-controlled trial (N = 99; N = 50 male; N = 49 female) was conducted to investigate the efficacy of intravenous ketamine versus active placebo as augmentation of antidepressant therapy for TRD. Patients were assigned to one of five arms; one-time administration of ketamine of varying doses (i.e., 0.1, 0.2, 0.5, and 1.0 mg/kg), and one group receiving active placebo (intravenous midazolam). A priori-planned analyses were conducted to compare responses between women and men, as well pre-vs. postmenopausal women.
RESULTS


Analyses demonstrated no significant differences between women and men in terms of treatment response (F(1,80) = 0.06, p = 0.80). There were no significant differences in the frequency of adverse effects (AEs) reported by those assigned to ketamine treatment groups (p > 0.21 for all AEs reported more than once), although women reported more headaches (12% vs. 6%, p = 0.30) and nausea (10% vs. 6%, p = 0.47). In comparing pre-vs. postmenopausal women, no differences in efficacy were observed (F(1,76) = 0.36, p = 0.55).
CONCLUSIONS


Results do not support differential efficacy or tolerability of ketamine for the treatment of TRD between women and men, nor based on menopause status among women. However, larger trials with these a priori aims are needed to confirm these results.",2019,"There were no significant differences in the frequency of adverse effects (AEs) reported by those assigned to ketamine treatment groups (p > 0.21 for all AEs reported more than once), although women reported more headaches (12% vs. 6%, p = 0.30) and nausea (10% vs. 6%, p = 0.47).","['women and men, as well pre-vs. postmenopausal women', 'controlled trial (N\u202f=\u202f99; N\u202f=\u202f50 male; N\u202f=\u202f49 female', 'men and women, and between pre- and post-menopausal women']","['ketamine', 'active placebo (intravenous midazolam', 'ketamine versus active placebo', 'placebo']","['treatment response (F(1,80', 'headaches', 'efficacy', 'frequency of adverse effects (AEs', 'nausea']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",,0.456424,"There were no significant differences in the frequency of adverse effects (AEs) reported by those assigned to ketamine treatment groups (p > 0.21 for all AEs reported more than once), although women reported more headaches (12% vs. 6%, p = 0.30) and nausea (10% vs. 6%, p = 0.47).","[{'ForeName': 'Marlene P', 'Initials': 'MP', 'LastName': 'Freeman', 'Affiliation': 'Massachusetts General Hospital, USA. Electronic address: mfreeman@partners.org.'}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Massachusetts General Hospital, USA.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Hoeppner', 'Affiliation': 'Massachusetts General Hospital, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Mazzone', 'Affiliation': 'Massachusetts General Hospital, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Judge', 'Affiliation': 'Massachusetts General Hospital, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cusin', 'Affiliation': 'Massachusetts General Hospital, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Mathew', 'Affiliation': 'Baylor College of Medicine/Michael E. Debakey VA Medical Center, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'Yale University, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Iosifescu', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'DeBattista', 'Affiliation': 'Stanford University School of Medicine, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.01.010']
351,32172686,Adults with cystic fibrosis: spiritual coping with lifelong disease.,"Cystic fibrosis (CF) is a chronic life-shortening disease requiring significant coping. Spiritual belief relates to treatment behaviors. Little is known about spirituality's role in adults diagnosed as children, nor how it compares with adults diagnosed as adults. Adults over 18 years, diagnosed as children completed a questionnaire; some were randomized to also participate in an interview or daily phone diary to measure adherence. Qualitative analyses of 25 adults are presented. Participants reframed their disease as part of a Divine Plan, in which Divine assistance was conditional upon adherence. Linear regression models of spiritual constructs on airway clearance, nebulized medication, and exercise are presented. Adults diagnosed as children related spirituality to CF in ways both consistent and different from adults diagnosed as adults. Spiritual beliefs were related to adherence determinants and intentions. Increased understanding of the relationship between spirituality and health behaviors is important to providing person-centered care.",2020,Spiritual beliefs were related to adherence determinants and intentions.,"['25 adults', 'adults diagnosed as children', 'Adults over 18\u2009years, diagnosed as children completed a questionnaire', 'Adults with cystic fibrosis']",[],['Spiritual beliefs'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}]",[],"[{'cui': 'C0004951', 'cui_str': 'Beliefs'}]",,0.0200191,Spiritual beliefs were related to adherence determinants and intentions.,"[{'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Grossoehme', 'Affiliation': 'Department of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Adam G', 'Initials': 'AG', 'LastName': 'Cole', 'Affiliation': 'Department of Internal Medicine, College of Medicine, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Lewis', 'Affiliation': ""Division of Pulmonary Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Sophia M', 'Initials': 'SM', 'LastName': 'Stamper', 'Affiliation': ""Division of Pulmonary Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Teeters', 'Affiliation': ""Division of Pulmonary Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Joseph', 'Affiliation': ""Division of Pulmonary Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}]",Journal of health care chaplaincy,['10.1080/08854726.2020.1713647']
352,32176813,A Comparison of Bone-Targeted Exercise Strategies to Reduce Fracture Risk in Middle-Aged and Older Men with Osteopenia and Osteoporosis: LIFTMOR-M Semi-Randomized Controlled Trial.,"The Lifting Intervention For Training Muscle and Osteoporosis Rehabilitation for Men (LIFTMOR-M) trial examined efficacy and safety of two novel exercise programs in older men with low BMD. Men with low hip and/or LS BMD were randomized to high-intensity progressive resistance and impact training (HiRIT) or machine-based isometric axial compression (IAC) and compared to a nonrandomized matched control (CON). Outcomes included: hip and LS BMD; calcaneal ultrasound parameters; anthropometry; body composition; function (timed up-and-go [TUG], five-times sit-to-stand [FTSTS]); back extensor strength (BES); leg extensor strength (LES); compliance and adverse events. Ninety-three men (67.1 ± 7.5 years; 82.1 ± 11.6 kg; 175.2 ± 6.7 cm; FN T-score -1.6 ± 0.6) were randomized to HiRIT (n = 34) or IAC (n = 33), or allocated to CON (n = 26). HiRIT improved trochanteric BMD (2.8 ± 0.8%; -0.1 ± 0.9%, p = .024), LS BMD (4.1 ± 0.7%; 0.9 ± 0.8%, p = .003), BUA (2.2 ± 0.7%; -0.8 ± 0.9%, p = .009), stiffness index (1.6 ± 0.9%; -2.0 ± 1.1%, p = .011), lean mass (1.5 ± 0.8%; -2.4 ± 0.9%, p = .002), TUG, FTSTS, BES, and LES (p < .05) compared with CON. IAC improved lean mass (0.8 ± 0.8%; -2.4 ± 0.9%, p = .013) and FTSTS (-4.5 ± 1.6%; 7.5 ± 2.0%, p < .001) compared with CON. HiRIT improved LS BMD (4.1 ± 0.7%; 2.0 ± 0.7%, p = .039), stiffness index (1.6 ± 0.9%; -1.3 ± 0.9%, p = .025), and FTSTS (-10.7 ± 1.6%; -4.5 ± 1.7%, p = .010) compared with IAC. Exercise compliance was high (HiRIT 77.8 ± 16.6%; IAC 78.5 ± 14.8%, p = .872). There were five minor adverse events (HiRIT, 2; IAC, 3). HiRIT was well-tolerated and improved bone, function and fracture risk more than CON or IAC. © 2020 American Society for Bone and Mineral Research.",2020,"IAC improved lean mass (0.8±0.8%; -2.4±0.9%, p=0.013) and FTSTS (-4.5±1.6%; 7.5±2.0%, p<0.001) compared with CON.","['middle-aged and older men with osteopenia and osteoporosis', 'Ninety-three men (67.1±7.5yrs; 82.1±11.6kg; 175.2±6.7cm; FN T-score -1.6±0.6) were recruited, and randomized to HiRIT (n=34) or', 'Men with low proximal femur and/or LS BMD', 'men with low BMD', 'middle-aged and older men with low BMD']","['high-intensity progressive resistance and impact training (HiRIT) or machine-based isometric axial compression (IAC', 'CON', 'Lifting Intervention For Training Muscle and Osteoporosis Rehabilitation', 'IAC', 'bone-targeted exercise programs', 'bone-targeted exercise strategies']","['Compliance', 'broadband ultrasound attenuation', 'stiffness index', 'positive stimulus to bone and functional indices of falls and fracture risk', 'lean mass', 'efficacy and safety', 'fracture risk', 'HiRIT effects', 'LS BMD', 'proximal femur and LS BMD; calcaneal ultrasound parameters; anthropometry; body composition; physical function (timed up-and-go [TUG], five-times sit-to-stand [FTSTS]); muscle strength (back [BES] and leg extensor strength [LES]); compliance and adverse events', 'IAC improved lean mass', 'trochanteric BMD']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0181620', 'cui_str': 'Lift'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",,0.0469398,"IAC improved lean mass (0.8±0.8%; -2.4±0.9%, p=0.013) and FTSTS (-4.5±1.6%; 7.5±2.0%, p<0.001) compared with CON.","[{'ForeName': 'Amy T', 'Initials': 'AT', 'LastName': 'Harding', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Australia.'}, {'ForeName': 'Benjamin K', 'Initials': 'BK', 'LastName': 'Weeks', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Australia.'}, {'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'Lambert', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Australia.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Watson', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Australia.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Weis', 'Affiliation': 'The Bone Clinic, Brisbane, Australia.'}, {'ForeName': 'Belinda R', 'Initials': 'BR', 'LastName': 'Beck', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Australia.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4008']
353,32219594,Does M1 anodal transcranial direct current stimulation affects online and offline motor learning in patients with multiple sclerosis?,"OBJECTIVE


Multiple Sclerosis (MS) is one of the most common neurological diseases in the world. Due to structural and functional changes in central nerves system, the patients with MS may affected by sensory-motor learning deficits. The aims of the current study was to assess the effect of primary motor cortex (M1) anodal transcranial direct current stimulation (a-tDCS) on online and offline motor learning in patients with MS.
MATERIALS AND METHODS


Thirty-nine patients with MS were randomly assigned in three groups: concurrent M1 a-tDCS and serial response time test (SRTT) (n=13), concurrent sham a-tDCS and SRTT (n=13) and SRTT-only control (n=13). The participants in all groups were asked to concurrently perform 20 minutes of SRTT. M1 a-tDCS group received 20-minute M1 a-tDCS (2 mA) concurrent with SRTT, while the a-tDCS was turned off after 30 seconds in the sham a-tDCS group. Response time (RT) and error rate (ER) during SRTT were assessed prior, during and 48 hours after the intervention.
RESULTS


Online learning happened in all groups (P < 0.05), with more significant learning in M1 a-tDCS group as compared to the other groups (P < 0.05). However, offline learning was occurred only in M1 a-tDCS group (P < 0.05).
CONCLUSIONS


The findings indicate offline motor learning impairment in patients with MS. M1 a-tDCS may be used for enhancement of motor learning especially offline learning in patients with MS.",2020,"RESULTS


Online learning happened in all groups (P < 0.05), with more significant learning in M1 a-tDCS group as compared to the other groups (P < 0.05).","['patients with MS', 'patients with multiple sclerosis', 'Thirty-nine patients with MS']","['concurrent M1 a-tDCS and serial response time test (SRTT) (n=13), concurrent sham a-tDCS and SRTT (n=13) and SRTT-only control', 'M1 anodal transcranial direct current stimulation', '20-minute M1 a-tDCS (2 mA) concurrent with SRTT', 'primary motor cortex (M1) anodal transcranial direct current stimulation (a-tDCS']",['Response time (RT) and error rate (ER'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}]",39.0,0.0196044,"RESULTS


Online learning happened in all groups (P < 0.05), with more significant learning in M1 a-tDCS group as compared to the other groups (P < 0.05).","[{'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Masoudian', 'Affiliation': 'Neurology Ward, Department of Internal Medicine, School of Medicine, Kosar Hospital, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Ehsani', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran. fatemehehsani59@yahoo.com.'}, {'ForeName': 'Monireh', 'Initials': 'M', 'LastName': 'Nazari', 'Affiliation': 'Student Research Committee, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Zoghi', 'Affiliation': 'Discipline of Physiotherapy, Department of Rehabilitation, Nutrition and Sport, School of Allied Health, La Trobe University, Bundoora, Melbourne, Victoria, 3086, Australia.'}, {'ForeName': 'Shapour', 'Initials': 'S', 'LastName': 'Jaberzadeh', 'Affiliation': 'Department of Physiotherapy, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}]",Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology,['10.1007/s10072-020-04359-9']
354,32227774,"Effect of acupressure on postpartum low back pain, salivary cortisol, physical limitations, and depression: a randomized controlled pilot study.","OBJECTIVE


To investigate the effect of acupressure on postpartum low back pain (LBP), salivary cortisol, physical limitations, and postpartum depression.
METHODS


Participants were 70 postpartum women who were randomly assigned to either an intervention (n = 35) or a control (n = 35) group. The intervention group received 10 acupressure sessions (1 session per day, 5 d per week). The control group received 10 sham acupressure sessions. Outcomes were assessed using a visual analogue scale (LBP intensity), salivary cortisol values (LBP biomarker), and Chinese versions of the Roland-Morris Disability Questionnaire (daily activity limitations), Oswestry Disability Index (physical activity limitations), and the Edinburgh Postnatal Depression Scale (postpartum depression).
RESULTS


Participants in the intervention group had significantly lower levels of LBP intensity, daily activity limitations, physical activity limitations, and postpartum depression than those in the control group. There was no significant between-group difference in salivary cortisol.
CONCLUSION


Acupressure may reduce postpartum LBP intensity and limitations in daily and physical activity, and alleviate postpartum depressive symptoms. Acupressure should be offered in postpartum care settings as an alternative treatment for postpartum women with LBP.",2020,"RESULTS


Participants in the intervention group had significantly lower levels of LBP intensity, daily activity limitations, physical activity limitations, and postpartum depression than those in the control group.","['Participants were 70 postpartum women who were randomly assigned to either an intervention (n = 35) or a control (n = 35) group', 'postpartum women with LBP']","['Acupressure', '10 acupressure sessions', 'acupressure', '10 sham acupressure sessions']","['postpartum low back pain, salivary cortisol, physical limitations, and depression', 'postpartum LBP intensity and limitations in daily and physical activity', 'visual analogue scale (LBP intensity), salivary cortisol values (LBP biomarker), and Chinese versions of the Roland-Morris Disability Questionnaire (daily activity limitations), Oswestry Disability Index (physical activity limitations), and the Edinburgh Postnatal Depression Scale (postpartum depression', 'LBP intensity, daily activity limitations, physical activity limitations, and postpartum depression', 'salivary cortisol', 'postpartum low back pain (LBP), salivary cortisol, physical limitations, and postpartum depression']","[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}]",70.0,0.0853547,"RESULTS


Participants in the intervention group had significantly lower levels of LBP intensity, daily activity limitations, physical activity limitations, and postpartum depression than those in the control group.","[{'ForeName': 'Hsuesh-Yu', 'Initials': 'HY', 'LastName': 'Cheng', 'Affiliation': 'Department of Nursing, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung 80830, Taiwan China.'}, {'ForeName': 'Shieh', 'Initials': 'S', 'LastName': 'Carol', 'Affiliation': 'Department of Community and Health Systems, Indiana University School of Nursing, Indiana 600, USA.'}, {'ForeName': 'BeiYu', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung 80830, Taiwan China.'}, {'ForeName': 'Yu-Fen', 'Initials': 'YF', 'LastName': 'Cheng', 'Affiliation': 'Department of Nursing, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung 80830, Taiwan China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
355,30765298,"Make It Fresh, for Less! A Supermarket Meal Bundling and Electronic Reminder Intervention to Promote Healthy Purchases Among Families With Children.","OBJECTIVE


To evaluate the effects of a supermarket meal bundling and electronic reminder intervention on food choices of families with children.
DESIGN


Quasi-experimental (meal bundling) and randomized, controlled trial (electronic reminders).
SETTING


Large supermarket in Maine during 40-week baseline and 16-week intervention periods in 2015-2016.
PARTICIPANTS


English-speaking adults living with at least 1 child aged ≤18 years (n = 300) with 25% of households participating in the Supplemental Nutrition Assistance Program.
INTERVENTION(S)


(1) Four bundles of ingredients needed to make 8 low-cost healthful meals were promoted in the store through displays and point-of-purchase messaging for 4 weeks each; (2) weekly electronic messages based on principles from behavioral psychology were sent to study participants reminding them to look for meal bundles in the store.
MAIN OUTCOME MEASURES


(1) Difference in storewide sales and individual purchases of bundled items (measured using supermarket loyalty card data) from baseline to intervention in intervention vs control groups.
ANALYSIS


Regressions controlling for total food spending and accounting for repeated measures.
RESULTS


There were no differences in spending on bundled items resulting from the meal bundling intervention or the electronic reminders.
CONCLUSIONS AND IMPLICATIONS


Overall, there was little impact of healthful meal bundles and electronic reminders on storewide sales or purchases of promoted items in a large supermarket.",2019,"Overall, there was little impact of healthful meal bundles and electronic reminders on storewide sales or purchases of promoted items in a large supermarket.","['English-speaking adults living with at least 1 child aged ≤18 years (n\u202f=\u202f300) with 25% of households participating in the Supplemental Nutrition Assistance Program', 'families with children', 'Large supermarket in Maine during 40-week baseline and 16-week intervention periods in 2015-2016', 'Families']","['supermarket meal bundling and electronic reminder intervention', 'INTERVENTION(S)\n\n\n(1) Four bundles of ingredients needed to make 8 low-cost healthful meals were promoted in the store through displays and point-of-purchase messaging for 4 weeks each; (2) weekly electronic messages based on principles from behavioral psychology were sent to study participants reminding them to look for meal bundles in the store', 'Supermarket Meal Bundling and Electronic Reminder Intervention']",['1) Difference in storewide sales and individual purchases of bundled items'],"[{'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C3494397', 'cui_str': 'SNAP Program'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0557778', 'cui_str': 'Supermarket (environment)'}, {'cui': 'C0024497', 'cui_str': 'Maine'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0557778', 'cui_str': 'Supermarket (environment)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0557033', 'cui_str': 'Reminding (procedure)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}]","[{'cui': 'C0036070', 'cui_str': 'Sales'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",,0.0742669,"Overall, there was little impact of healthful meal bundles and electronic reminders on storewide sales or purchases of promoted items in a large supermarket.","[{'ForeName': 'Alyssa J', 'Initials': 'AJ', 'LastName': 'Moran', 'Affiliation': 'Department of Health Policy and Management, Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, MD; Department of Nutrition, Harvard T.H. Chan School of Public Health, Harvard University, Boston, MA. Electronic address: amoran10@jhu.edu.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Khandpur', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Harvard University, Boston, MA; Center for Epidemiological Studies in Health and Nutrition, Faculty of Public Health, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Polacsek', 'Affiliation': 'Westbrook College of Health Professions, University of New England, Portland, ME.'}, {'ForeName': 'Anne N', 'Initials': 'AN', 'LastName': 'Thorndike', 'Affiliation': 'Harvard Medical School, Boston, MA; Division of General Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Franckle', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Harvard University, Boston, MA; School of Health Sciences, Merrimack College, North Andover, MA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Boulos', 'Affiliation': 'Muskie School of Public Service, University of Southern Maine, Portland, ME.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Sampson', 'Affiliation': 'ChopChop Family, Belmont, MA.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Greene', 'Affiliation': 'Hannaford Supermarkets, Scarborough, ME.'}, {'ForeName': 'Dan G', 'Initials': 'DG', 'LastName': 'Blue', 'Affiliation': 'Hannaford Supermarkets, Scarborough, ME.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Rimm', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Harvard University, Boston, MA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Harvard University, Boston, MA.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2019.01.012']
356,32083686,Effect of Physician Gender and Race on Simulated Patients' Ratings and Confidence in Their Physicians: A Randomized Trial.,"Importance


Women and black physicians encounter workplace challenges because of their gender and race. It is unclear whether these individuals are assessed with lower patient satisfaction or confidence ratings compared with white male physicians.
Objective


To examine whether physician gender and race affect participant ratings in scenarios in which physician competence is challenged.
Design, Setting, and Participants


This randomized trial enrolled a geographically diverse sample of 3592 online respondents in the United States who were recruited from 2 crowdsourcing platforms: Amazon Mechanical Turk (n = 1741) and Lucid (n = 1851). A 2 × 2 factorial design for the gender and race of simulated physicians was conducted between March 9 and July 25, 2018. Participants were excluded before intervention if they were younger than 18 years, were pregnant, or had a history of cancer or abdominal surgical procedures.
Interventions


A clinical vignette was presented to the participant with a picture of the emergency department physician. Participants were randomly assigned to physicians with different gender and race, with 823 assigned to black women, 791 to black men, 828 to white women, and 835 to white men. A contradictory diagnosis from an online symptom checker introduced doubt about the clinical diagnosis.
Main Outcomes and Measures


A composite outcome (range, 0-100, with 0 representing low patient confidence and satisfaction and 100 representing the maximum on the composite scale) measured participant (1) confidence in the physician, (2) satisfaction with care, (3) likelihood to recommend the physician, (4) trust in the physician's diagnosis, and (5) likelihood to request additional tests.
Results


Among 3277 adult participants, complete data were available for 3215 (median age, 49 years [range, 18-89 years]; 1667 [52%] female; 2433 [76%] white). No significant differences were observed in participant satisfaction and physician confidence for the white male physician control physicians (mean composite score, 66.13 [95% CI, 64.76-67.51]) compared with white female (mean composite score, 66.50 [95% CI, 65.19-67.82]), black female (mean composite score, 67.36 [95% CI, 66.03-68.69]), and black male (mean composite score, 66.96 [95% CI, 65.55-68.36]) physicians. Machine learning with bayesian additive regression trees revealed no evidence of treatment effect heterogeneity as a function of participants' race, gender, racial prejudice, or sexism.
Conclusions and Relevance


No significant differences were observed for simulated patients' evaluations of female or black physicians, suggesting that bias in favor of white male physicians is negligible in survey-based measures of patient satisfaction.
Trial Registration


ClinicalTrials.gov Identifier: NCT04190901.",2020,"Machine learning with bayesian additive regression trees revealed no evidence of treatment effect heterogeneity as a function of participants' race, gender, racial prejudice, or sexism.
","['3277 adult participants, complete data were available for 3215 (median age, 49 years [range, 18-89 years]; 1667 [52%] female; 2433 [76%] white', 'Participants were excluded before intervention if they were younger than 18 years, were pregnant, or had a history of cancer or abdominal surgical procedures', 'geographically diverse sample of 3592 online respondents in the United States who were recruited from 2 crowdsourcing platforms: Amazon Mechanical Turk (n\u2009=\u20091741) and Lucid (n\u2009=\u20091851', 'Participants were randomly assigned to physicians with different gender and race, with 823 assigned to black women, 791 to black men, 828 to white women, and 835 to white men']",[],"['participant satisfaction and physician confidence', ""composite scale) measured participant (1) confidence in the physician, (2) satisfaction with care, (3) likelihood to recommend the physician, (4) trust in the physician's diagnosis, and (5) likelihood to request additional tests""]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4708909', 'cui_str': '1667 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0455471', 'cui_str': 'H/O: malignant neoplasm'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C3494387', 'cui_str': 'Crowdsource'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0337911', 'cui_str': 'Turks (ethnic group)'}, {'cui': 'C0556994', 'cui_str': 'Lucid (finding)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]",[],"[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",3277.0,0.157813,"Machine learning with bayesian additive regression trees revealed no evidence of treatment effect heterogeneity as a function of participants' race, gender, racial prejudice, or sexism.
","[{'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Solnick', 'Affiliation': 'National Clinical Scholars Program, Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Peyton', 'Affiliation': 'Yale Law School, New Haven, Connecticut.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Kraft-Todd', 'Affiliation': 'Department of Psychology, Boston College, Chestnut Hill, Massachusetts.'}, {'ForeName': 'Basmah', 'Initials': 'B', 'LastName': 'Safdar', 'Affiliation': 'Department of Emergency Medicine, Yale School of Medicine, New Haven, Connecticut.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.20511']
357,32219973,Immediate Effects of the Combination of Interferential Therapy Parameters on Chronic Low Back Pain: A Randomized Controlled Trial.,"OBJECTIVES


To compare the immediate analgesic effects of 2 kHz or 4 kHz interferential current (IFC) with different amplitude-modulated frequencies (AMFs) (2 Hz or 100 Hz) on chronic low back pain (CLBP).
DESIGN


Three-arm double-blinded randomized controlled trial.
SETTING


Primary care.
PARTICIPANTS


175 patients (19 to 60 years of age, 105 female) with CLBP.
INTERVENTIONS


One session of IFC: Interferential group (GI): GI2 kHz/100 Hz, GI2 kHz/2 Hz, GI4  kHz/100 Hz, GI4 kHz/2 Hz, or placebo.
MAIN OUTCOMES MEASURES


Pain intensity by numerical rating scale of pain (NRS), McGill Pain Questionnaire (MPQ), and algometry.
RESULTS


There was a significant difference in NRS scores (P < 0.05) in the GI2 kHz/2 Hz, GI4 kHz/2 Hz, and GI4 kHz/100 Hz groups compared with those of the placebo group (PG), and a significant difference in MPQ scores in the GI4 kHz/2 Hz and GI4 kHz/100 Hz groups compared with those of the PG. In algometry, only the GI4 kHz/100 Hz group showed a significant difference (by 2 points in the lumbar region) compared with the PG. Of the carrier frequencies, an IFC of 4 kHz showed more effective results, although no significant difference was noted between the AMFs.
CONCLUSION


An IFC with a carrier frequency of 4 kHz and an AMF of 100 Hz provide immediate analgesic effects in individuals with CLBP.
CLINICAL TRIAL REGISTRATION NUMBER


RBR-59YGRB.",2020,"there was a significant difference in NRS (p<0.05) of GI2kHz/2Hz, GI4kHz/2Hz, and GI4kHz/100Hz groups, compared with that of PG and in MPQ of GI4kHz/2Hz and GI4kHz/100Hz groups, compared with that of PG.","['175 patients (aged 19-60 years, 105 female) with CLBP', 'chronic low back pain', 'individuals with CLBP']","['IFC: GI2kHz/100Hz, GI2kHz/2Hz, GI4kHz/100Hz, GI4kHz/2Hz, or placebo (PG', 'GI4kHz/100Hz', '2 kHz or 4 kHz interferential current (IFC) with different amplitude-frequency modulations (AMFs) (2Hz or 100Hz', 'interferential therapy parameters']","['chronic low back pain (CLBP', 'pain intensity by numerical rating scale of pain (NRS), McGill pain questionnaire (MPQ), and algometry']","[{'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556965', 'cui_str': 'kilohertz'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0556898', 'cui_str': 'Interferential therapy (regime/therapy)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024985', 'cui_str': 'McGill Pain Questionnaire'}]",175.0,0.281098,"there was a significant difference in NRS (p<0.05) of GI2kHz/2Hz, GI4kHz/2Hz, and GI4kHz/100Hz groups, compared with that of PG and in MPQ of GI4kHz/2Hz and GI4kHz/100Hz groups, compared with that of PG.","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Almeida', 'Affiliation': 'Department of Prevention and Rehabilitation in Physiotherapy, Universidade Federal do Paraná, Curitiba, Brazil.'}, {'ForeName': 'Luis Henrique', 'Initials': 'LH', 'LastName': 'Paladini', 'Affiliation': 'Department of Prevention and Rehabilitation in Physiotherapy, Universidade Federal do Paraná, Curitiba, Brazil.'}, {'ForeName': 'RacieleIvandra Guarda', 'Initials': 'RG', 'LastName': 'Korelo', 'Affiliation': 'Department of Prevention and Rehabilitation in Physiotherapy, Universidade Federal do Paraná, Curitiba, Brazil.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Liebano', 'Affiliation': 'Physiotherapy Department, Universidade Federal de São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Ana Carolina Brandt', 'Initials': 'ACB', 'LastName': 'de Macedo', 'Affiliation': 'Department of Prevention and Rehabilitation in Physiotherapy, Universidade Federal do Paraná, Curitiba, Brazil.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12888']
358,32212856,Augmenting Computerized Cognitive Training With Vortioxetine for Age-Related Cognitive Decline: A Randomized Controlled Trial.,"OBJECTIVE


Age-related cognitive decline, the deterioration in functions such as memory and executive function, is faced by most older adults and affects function and quality of life. No approved treatments exist for age-related cognitive decline. Computerized cognitive training has been shown to provide consistent albeit modest improvements in cognitive function as measured by neuropsychological testing. Vortioxetine, an antidepressant medication, has putative procognitive and proneuroplastic properties and therefore may be able to augment cognitive training. In this placebo-controlled study, the authors tested the cognitive benefits of vortioxetine added to cognitive training for adults age 65 or older with age-related cognitive decline.
METHODS


After a 2-week lead-in period of cognitive training, 100 participants were randomly assigned to receive either vortioxetine or placebo in addition to cognitive training for 26 weeks. The primary outcome measure was global cognitive performance, assessed by the NIH Toolbox Cognition Battery Fluid Cognition Composite. The secondary outcome measure was functional cognition, assessed by the UCSD Performance-Based Skills Assessment. All participants received motivational messaging and support from study staff to maximize adherence to the training.
RESULTS


Participants who received vortioxetine with cognitive training showed a greater increase in global cognitive performance compared with those who received placebo with cognitive training. This separation was significant at week 12 but not at other assessment time points. Both groups showed improvement in the secondary outcome measure of functional cognition, with no significant difference between groups.
CONCLUSIONS


Vortioxetine may be beneficial for age-related cognitive decline when combined with cognitive training. These findings provide new treatment directions for combating cognitive decline in older adults.",2020,"RESULTS


Participants who received vortioxetine with cognitive training showed a greater increase in global cognitive performance compared with those who received placebo with cognitive training.","['adults age 65 or older with age-related cognitive decline', '100 participants', 'Age-Related Cognitive Decline', 'older adults']","['vortioxetine added to cognitive training', 'Computerized cognitive training', 'Computerized Cognitive Training With Vortioxetine', 'placebo', 'motivational messaging', 'vortioxetine or placebo', 'vortioxetine with cognitive training', 'Vortioxetine']","['cognitive function', 'global cognitive performance, assessed by the NIH Toolbox Cognition Battery Fluid Cognition Composite', 'global cognitive performance', 'functional cognition', 'functional cognition, assessed by the UCSD Performance-Based Skills Assessment']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0236848', 'cui_str': 'Age-related cognitive decline (finding)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0729447', 'cui_str': 'Battery fluid (substance)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",100.0,0.154771,"RESULTS


Participants who received vortioxetine with cognitive training showed a greater increase in global cognitive performance compared with those who received placebo with cognitive training.","[{'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Stevens', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Jill D', 'Initials': 'JD', 'LastName': 'Waring', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Vy T', 'Initials': 'VT', 'LastName': 'Pham', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Haddad', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Shimony', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Bowie', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}]",The American journal of psychiatry,['10.1176/appi.ajp.2019.19050561']
359,32207575,Topical moistening of mastectomy wounds with diluted tranexamic acid to reduce bleeding: randomized clinical trial.,"BACKGROUND


Topical administration of tranexamic acid (TXA) may be an alternative to intravenous administration to reduce bleeding with a lower risk of systemic adverse events. The aim of this study was to investigate whether moistening a surgical wound with TXA before closure, leaving a thin film of drug only, would reduce postoperative bleeding.
METHODS


This was a two-centre, stratified, parallel-group, placebo-controlled, double-blind RCT. Patients undergoing mastectomy with or without axillary lymph node clearance were randomized 1 : 1 to moistening of wound surface before closure with either 25 mg/ml TXA or 0·9 per cent sodium chloride (placebo). The primary endpoint was postoperative bleeding as measured by drain production in the first 24 h. Secondary endpoints were early haematoma, total drain production, postoperative complications and late aspirations of seroma within 3 months.
RESULTS


Between 1 January 2016 and 31 August 2018, 208 patients were randomized. Two patients were converted to a different surgical procedure at surgery, and four did not receive the intervention owing to technical error. Thus, 202 patients were included in the study (101 in the TXA and 101 in the placebo group). TXA reduced mean drain production at 24 h (110 versus 144 ml; mean difference 34 (95 per cent c.i. 8 to 60) ml, P = 0·011). One patient in the TXA group had early haematoma compared with seven in the placebo group (odds ratio (OR) 0·13 (95 per cent c.i. 0·02 to 1·07); P = 0·057). There was no significant difference in postoperative complications between TXA and placebo (13 versus 10; OR 1·11 (0·45 to 2·73), P = 0·824) or need for late seroma aspirations (79 versus 67 per cent; OR 1·83 (0·91 to 3·68), P = 0·089).
CONCLUSION


Moistening the wound with TXA 25 mg/ml before closure reduces postoperative bleeding within the first 24 h in patients undergoing mastectomy. Registration number: NCT02627560 (https://clinicaltrials.gov).",2020,TXA reduced mean drain production at 24 h (110 versus 144 ml; mean difference 34,"['Patients undergoing mastectomy with or without axillary lymph node clearance', '202 patients were included in the study (101 in the TXA and 101 in the placebo group', 'Between 1 January 2016 and 31 August 2018, 208 patients were randomized']","['placebo-controlled, double-blind RCT', 'placebo', 'TXA', 'diluted tranexamic acid', 'moistening of wound surface before closure with either 25\u2009mg/ml TXA or 0·9 per cent sodium chloride (placebo', 'tranexamic acid (TXA', 'TXA and placebo']","['postoperative complications', 'postoperative bleeding', 'mean drain production', 'bleeding', 'early haematoma, total drain production, postoperative complications and late aspirations of seroma within 3\u2009months', 'postoperative bleeding as measured by drain production', 'late seroma aspirations', 'early haematoma']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024886', 'cui_str': 'Total Mastectomy'}, {'cui': 'C0398402', 'cui_str': 'Complete axillary lymphadenectomy (procedure)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0562018', 'cui_str': 'cent (qualifier value)'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0033268'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",202.0,0.469149,TXA reduced mean drain production at 24 h (110 versus 144 ml; mean difference 34,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ausen', 'Affiliation': ""Section for Plastic and Reconstructive Surgery, Clinic of Surgery, St Olav's University Hospital, Trondheim, Norway.""}, {'ForeName': 'A I', 'Initials': 'AI', 'LastName': 'Hagen', 'Affiliation': ""Section for Breast and Endocrine Surgery, Clinic of Surgery, St Olav's University Hospital, Trondheim, Norway.""}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Østbyhaug', 'Affiliation': ""Section for Breast and Endocrine Surgery, Clinic of Surgery, St Olav's University Hospital, Trondheim, Norway.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Olafsson', 'Affiliation': 'Section for Breast and Endocrine Surgery, Department of Surgery, Ålesund Hospital, Møre and Romsdal Hospital Trust, Ålesund, Norway.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Kvalsund', 'Affiliation': 'Section for Breast and Endocrine Surgery, Department of Surgery, Ålesund Hospital, Møre and Romsdal Hospital Trust, Ålesund, Norway.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Spigset', 'Affiliation': ""Department of Clinical Pharmacology, St Olav's University Hospital, Trondheim, Norway.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Pleym', 'Affiliation': ""Clinic of Anaesthesia and Intensive Care, St Olav's University Hospital, Trondheim, Norway.""}]",BJS open,['10.1002/bjs5.50248']
360,32191142,Enrollment and transition challenges in the International Maternal Pediatric and Adolescent AIDS Clinical Trials (IMPAACT) network's PROMISE trial for resource-limited regions.,"BACKGROUND


We describe enrollment and accrual challenges in the ""Promoting Maternal and Infant Survival Everywhere"" (PROMISE) trial conducted in resource-limited countries, as well as the challenges in transitioning participants from the antepartum to the postpartum components of the study.
METHODS


PROMISE was a large multi-national randomized controlled trial of the safety and efficacy of interventions to reduce perinatal transmission of HIV-1 (HIV) during pregnancy and breastfeeding and of interventions to preserve maternal health after cessation of perinatal transmission risk. The PROMISE study included two protocols for HIV-infected pregnant women in resource-limited countries who intended to either breastfeed or formula-feed their infants and did not meet country criteria for antiretroviral treatment. The PROMISE breastfeeding protocol (1077BF) used a sequential randomization design with up to three randomizations (Antepartum, Postpartum, and Maternal Health). The PROMISE formula-feeding protocol (1077FF) had two randomizations (Antepartum and Maternal Health). Women presenting to the clinic during early or active labor or in the immediate postpartum period were registered as Late Presenters and screened to determine whether eligible to participate in the Postpartum randomization.
RESULTS


The study was conducted at 14 sites in seven countries and opened to enrollment in April 2011. A total of 3259 pregnant women intending to breastfeed and an additional 284 pregnant women intending to formula feed were randomized in the Antepartum component. A total of 204 Late Presenters were registered during labor or after delivery. Enrollment was high among breastfeeding women (representing 96% of the target of 3400 women) but was lower than expected among women intending to formula feed (28% of 1000 expected) and late-presenting women (8% of 2500 expected). The successful overall enrollment and final primary study analyses results were attributed to substantial preparation before the study opened, collaboration among all stakeholders, close study monitoring during implementation and the flexibility to change and streamline the protocol.
CONCLUSIONS


Experiences from the PROMISE study illustrate the challenges of enrolling in longer term studies in the setting of rapidly evolving prevention and treatment standards priorities. The lessons learned will help the community, site investigators, and study coordinators in the design and implementation of future clinical trials.",2020,Enrollment was high among breastfeeding women (representing 96% of the target of 3400 women) but was lower than expected among women intending to formula feed (28% of 1000 expected) and late-presenting women (8% of 2500 expected).,"['14 sites in seven countries and opened to enrollment in April 2011', 'Women presenting to the clinic during early or active labor or in the immediate postpartum period were registered as Late Presenters and screened to determine whether eligible to participate in the Postpartum randomization', 'HIV-infected pregnant women in resource-limited countries who intended to either breastfeed or formula-feed their infants and did not meet country criteria for antiretroviral treatment', '3259 pregnant women intending to breastfeed and an additional 284 pregnant women intending to formula feed']",[],['perinatal transmission of HIV-1 (HIV'],"[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0233081', 'cui_str': 'Normal labor (finding)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],"[{'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",3259.0,0.112228,Enrollment was high among breastfeeding women (representing 96% of the target of 3400 women) but was lower than expected among women intending to formula feed (28% of 1000 expected) and late-presenting women (8% of 2500 expected).,"[{'ForeName': 'Konstantia', 'Initials': 'K', 'LastName': 'Angelidou', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Pat', 'Initials': 'P', 'LastName': 'Flynn', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Coletti', 'Affiliation': 'IMPAACT Operations Center, FHI 360, Durham, NC, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'McCarthy', 'Affiliation': 'IMPAACT Operations Center, FHI 360, Durham, NC, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Browning', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McIntyre', 'Affiliation': 'Anova Health Institute, Johannesburg, South Africa.'}, {'ForeName': 'Sean S', 'Initials': 'SS', 'LastName': 'Brummel', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Shapiro', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Camlin', 'Initials': 'C', 'LastName': 'Tierney', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical trials (London, England)",['10.1177/1740774520912428']
361,32216723,Assessment of Peroxide in Saliva During and After At-home Bleaching With 10% Carbamide and Hydrogen Peroxide Gels: A Clinical Crossover Trial.,"CLINICAL RELEVANCE


This study suggests that at-home bleaching systems are safe in relation to toxicity based on peroxide levels in saliva since the amount of peroxide potentially ingested is much lower than the estimated toxic dose.
SUMMARY


",2020,There was a significant difference for bleaching ( p =0.0001) and time ( p =0.0003) but not for interaction ( p =0.3121).,['Participants received bleaching treatments after the sequence randomization (n=10'],"['PT-HP/OpalescenceGo10%; CT-HP/WhiteClass10%; and CT-CP/OpalescencePF10', 'Carbamide and Hydrogen Peroxide Gels', 'hydrogen peroxide (HP) and carbamide peroxide (CP) with a prefilled tray (PT) or conventional tray (CT', 'Peroxide']","['peroxide levels', 'salivary flow (SF', 'bleaching', 'overall mean']","[{'cui': 'C0303749', 'cui_str': 'Bleach (substance)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0108342', 'cui_str': 'carbamide peroxide'}, {'cui': 'C0184054', 'cui_str': 'Tray (attribute)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0031180', 'cui_str': 'Peroxides'}]","[{'cui': 'C0031180', 'cui_str': 'Peroxides'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0303749', 'cui_str': 'Bleach (substance)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0373524,There was a significant difference for bleaching ( p =0.0001) and time ( p =0.0003) but not for interaction ( p =0.3121).,"[{'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Mailart', 'Affiliation': ''}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Sakassegawa', 'Affiliation': ''}, {'ForeName': 'Crg', 'Initials': 'C', 'LastName': 'Torres', 'Affiliation': ''}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Palo', 'Affiliation': ''}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Borges', 'Affiliation': ''}]",Operative dentistry,['10.2341/19-127-C']
362,30568260,Personalized nutrition: pretreatment glucose metabolism determines individual long-term weight loss responsiveness in individuals with obesity on low-carbohydrate versus low-fat diet.,"BACKGROUND/OBJECTIVES


The interaction between fasting plasma glucose (FPG) and fasting insulin (FI) concentrations and diets with different carbohydrate content were studied as prognostic markers of weight loss as recent studies up to 6 months of duration have suggested the importance of these biomarkers.
SUBJECTS/METHODS


This was a retrospective analysis of a clinical trial where participants with obesity were randomized to an ad libitum low-carbohydrate diet or a low-fat diet with low energy content (1200-1800 kcal/day [≈ 5.0-7.5 MJ/d]; ≤ 30% calories from fat) for 24 months. Participants were categorized (pretreatment) as normoglycemic (FPG < 5.6 mmol/L) or prediabetic (FPG ≥ 5.6-6.9 mmol/L) and further stratified by median FI. Linear mixed models were used to examine outcomes by FPG and FI values.
RESULTS


After 2 years, participants with prediabetes and high FI lost 7.2  kg (95% CI 2.1;12.2, P = 0.005) more with the low-fat than low-carbohydrate diet, whereas those with prediabetes and low FI tended to lose 6.2  kg (95% CI -0.9;13.3, P = 0.088) more on the low-carbohydrate diet than low-fat diet [mean difference: 13.3 kg (95% CI 4.6;22.0, P = 0.003)]. No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16).
CONCLUSIONS


Fasting plasma glucose and insulin are strong predictors of the weight loss response to diets with different macronutrient composition and might be a useful approach for personalized weight management.",2019,"No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16).
","['Participants were categorized (pretreatment) as normoglycemic (FPG\u2009<\u20095.6\u2009mmol/L) or prediabetic (FPG\u2009≥\u20095.6-6.9\u2009mmol/L) and further stratified by median FI', 'individuals with obesity on low-carbohydrate versus low-fat diet', 'participants with obesity']",['ad libitum low-carbohydrate diet or a low-fat diet with low energy content'],['fasting plasma glucose (FPG) and fasting insulin (FI) concentrations'],"[{'cui': 'C0580545', 'cui_str': 'Blood glucose normal (finding)'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}]","[{'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0200382,"No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16).
","[{'ForeName': 'Mads F', 'Initials': 'MF', 'LastName': 'Hjorth', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Copenhagen, Denmark. madsfiil@nexs.ku.dk.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Yishai', 'Initials': 'Y', 'LastName': 'Zohar', 'Affiliation': 'Gelesis, Boston, MA, USA.'}, {'ForeName': 'Lorien E', 'Initials': 'LE', 'LastName': 'Urban', 'Affiliation': 'Gelesis, Boston, MA, USA.'}, {'ForeName': 'R Drew', 'Initials': 'RD', 'LastName': 'Sayer', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Patterson', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Sharon J', 'Initials': 'SJ', 'LastName': 'Herring', 'Affiliation': 'Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Babette S', 'Initials': 'BS', 'LastName': 'Zemel', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Foster', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Wyatt', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}]",International journal of obesity (2005),['10.1038/s41366-018-0298-4']
363,32217876,Neurally Adjusted Ventilatory Assist versus Pressure Support Ventilation in Difficult Weaning: A Randomized Trial.,"BACKGROUND


Difficult weaning frequently develops in ventilated patients and is associated with poor outcome. In neurally adjusted ventilatory assist, the ventilator is controlled by diaphragm electrical activity, which has been shown to improve patient-ventilator interaction. The objective of this study was to compare neurally adjusted ventilatory assist and pressure support ventilation in patients difficult to wean from mechanical ventilation.
METHODS


In this nonblinded randomized clinical trial, difficult-to-wean patients (n = 99) were randomly assigned to neurally adjusted ventilatory assist or pressure support ventilation mode. The primary outcome was the duration of weaning. Secondary outcomes included the proportion of successful weaning, patient-ventilator asynchrony, ventilator-free days, and mortality. Weaning duration was calculated as 28 days for patients under mechanical ventilation at day 28 or deceased before day 28 without successful weaning.
RESULTS


Weaning duration in all patients was statistically significant shorter in the neurally adjusted ventilatory assist group (n = 47) compared with the pressure support ventilation group (n = 52; 3.0 [1.2 to 8.0] days vs. 7.4 [2.0 to 28.0], mean difference: -5.5 [95% CI, -9.2 to -1.4], P = 0.039). Post hoc sensitivity analysis also showed that the neurally adjusted ventilatory assist group had shorter weaning duration (hazard ratio, 0.58; 95% CI, 0.34 to 0.98). The proportion of patients with successful weaning from invasive mechanical ventilation was higher in neurally adjusted ventilatory assist (33 of 47 patients, 70%) compared with pressure support ventilation (25 of 52 patients, 48%; respiratory rate for neurally adjusted ventilatory assist: 1.46 [95% CI, 1.04 to 2.05], P = 0.026). The number of ventilator-free days at days 14 and 28 was statistically significantly higher in neurally adjusted ventilatory assist compared with pressure support ventilation. Neurally adjusted ventilatory assist improved patient ventilator interaction. Mortality and length of stay in the intensive care unit and in the hospital were similar among groups.
CONCLUSIONS


In patients difficult to wean, neurally adjusted ventilatory assist decreased the duration of weaning and increased ventilator-free days.",2020,Weaning duration in all patients was statistically significant shorter in the neurally adjusted ventilatory assist group (n = 47) compared with the pressure support ventilation group (n = 52,"['patients difficult to wean from mechanical ventilation', 'wean patients (n = 99', 'ventilated patients', 'Difficult Weaning']","['neurally adjusted ventilatory assist and pressure support ventilation', 'Neurally Adjusted Ventilatory Assist versus Pressure Support Ventilation', 'neurally adjusted ventilatory assist or pressure support ventilation mode', 'pressure support ventilation']","['shorter weaning duration', 'proportion of successful weaning, patient-ventilator asynchrony, ventilator-free days, and mortality', 'proportion of patients with successful weaning from invasive mechanical ventilation', 'Mortality and length of stay', 'patient ventilator interaction', 'respiratory rate', 'number of ventilator-free days', 'Weaning duration', 'duration of weaning', 'pressure support ventilation', 'duration of weaning and increased ventilator-free days']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}]","[{'cui': 'C3178854', 'cui_str': 'Neurally Adjusted Ventilatory Assist'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",99.0,0.15027,Weaning duration in all patients was statistically significant shorter in the neurally adjusted ventilatory assist group (n = 47) compared with the pressure support ventilation group (n = 52,"[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'From the Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, 210009, Jiangsu, China (L.L., X.X., Q.S., Y. Yu., F.X., J.X., Y. Yang, H.Q.) the Department of Intensive Care, Amsterdam University Medical Center, Amsterdam, The Netherlands (L.H.).'}, {'ForeName': 'Xiaoting', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Feiping', 'Initials': 'F', 'LastName': 'Xia', 'Affiliation': ''}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': ''}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Heunks', 'Affiliation': ''}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Qiu', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003207']
364,32020765,Dialkylcarbamoyl chloride-coated versus alginate dressings after pilonidal sinus excision: a randomized clinical trial (SORKYSA study).,"BACKGROUND


Disease of the pilonidal sinus is a common condition that affects mainly young adults. Options for management include excision of the sinus tracts, leaving the wound open to heal by secondary intention. The aim of this study was to compare wound healing with dialkylcarbamoyl chloride (DACC)-coated dressings versus alginate dressings.
METHODS


This multicentre trial randomized consecutive patients undergoing surgery for pilonidal disease to postoperative wound care with either DACC-coated or alginate dressings. The primary outcome was the proportion of wounds healed after 75 days. Secondary outcomes were the local status of wounds during the healing process, the quality assessment of the dressings by the patient, and the time needed to return to usual activities.
RESULTS


A total of 246 patients were included: 120 in the DACC-coated group and 126 in the alginate group. In per-protocol analysis, there were significantly more patients with completely healed wounds after 75 days in the DACC group than in the alginate group: 78 of 103 (75·7 per cent) versus 58 of 97 (60 per cent) respectively (odds ratio 2·55, 95 per cent c.i. 1·12 to 5·92; P = 0·023). During follow-up, wounds with alginate dressings had more fibrin than those with DACC-coated dressings, but the difference was not significant (P = 0·079). There was no difference between the two arms in patients' assessment of the dressings.
CONCLUSION


The number of wounds completely healed at 75 days was significantly higher for DACC-coated compared with alginate dressings. However, the preplanned, clinically significant improvement in healing of 20 per cent was not reached. Registration number: NCT02011802 ( https://clinicaltrials.gov/).",2020,The number of wounds completely healed at 75 days was significantly higher for DACC-coated compared with alginate dressings.,"['after pilonidal sinus excision', 'A total of 246 patients were included: 120 in the DACC-coated group and 126 in the alginate group', 'consecutive patients undergoing surgery for pilonidal disease to postoperative wound care with either']","['dialkylcarbamoyl chloride (DACC)-coated dressings versus alginate dressings', 'Dialkylcarbamoyl chloride-coated versus alginate dressings', 'DACC', 'DACC-coated or alginate dressings']","['healed wounds', 'proportion of wounds healed', 'healing', 'local status of wounds during the healing process, the quality assessment of the dressings by the patient, and the time needed to return to usual activities', 'number of wounds completely healed']","[{'cui': 'C0031925', 'cui_str': 'Pilonidal Cyst'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0102137', 'cui_str': 'alginate'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2317114', 'cui_str': 'Pilonidal disease'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0886052', 'cui_str': 'Administers care to wound sites'}]","[{'cui': 'C0008203', 'cui_str': 'Chlorides'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0102137', 'cui_str': 'alginate'}]","[{'cui': 'C1265679', 'cui_str': 'Wound, healed'}, {'cui': 'C0574776', 'cui_str': 'Wound healed (finding)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}]",246.0,0.059149,The number of wounds completely healed at 75 days was significantly higher for DACC-coated compared with alginate dressings.,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Romain', 'Affiliation': 'Department of Digestive Surgery, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mielcarek', 'Affiliation': 'Department of Public Health, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Delhorme', 'Affiliation': 'Department of Digestive Surgery, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Meyer', 'Affiliation': 'Department of Public Health, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Brigand', 'Affiliation': 'Department of Digestive Surgery, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rohr', 'Affiliation': 'Department of Digestive Surgery, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJS open,['10.1002/bjs5.50259']
365,32215767,"Evaluation of the clinical and biochemical efficacy of erbium, chromium:ytrium-scandium-gallium-garnet (ER,CR:YSGG) laser treatment in periodontitis.","The objective of this study was to evaluate the clinical and biochemical efficacy of erbium, chromium:ytrium-scandium-gallium-garnet (Er,Cr:YSGG) laser treatment, in addition to non-surgical periodontal treatment (NSPT), in periodontitis patients. This was a single-centre, split-mouth, randomized, controlled 6-month clinical trial. Twenty-seven patients with moderate to advanced periodontitis were included in the study. The patients were randomly assigned to a debridement and laser treatment group or control group (debridement alone). Clinical measurements were performed at baseline and 1, 3 and 6 months post-treatment. The following parameters were measured: plaque index (PI), gingival index (GI), probing depth (PD), clinical attachment level (CAL), bleeding on probing (BoP), gingival crevicular fluid (GCF) volume and IL-1β and MMP-8 levels in GCF. There were statistically significant clinical improvements in both groups, with no significant between-group differences in PD, CAL, PI and BoP clinical measurements (p < 0.05). As compared with the control group, the GI 1 and 3 months post-treatment and BoP 1 month post-treatment were significantly improved in the laser group (p < 0.05). There was also a significant reduction in IL-1 β levels in both groups at baseline versus those 1, 3 and 6 months later (p < 0.05) There was no statistically significant difference in IL-1β and MMP-8 levels between groups (p < 0.05). Both the treatment modalities resulted in significant improvements in clinical parameters. Within the limitations of this study, Er,Cr:YSGG laser treatment applied in addition to NSPT is indicated to reduce clinical inflammation.",2020,"There was also a significant reduction in IL-1 β levels in both groups at baseline versus those 1, 3 and 6 months later (p < 0.05)","['periodontitis', 'Twenty-seven patients with moderate to advanced periodontitis', 'periodontitis patients']","['debridement and laser treatment group or control group (debridement alone', 'erbium, chromium:ytrium-scandium-gallium-garnet', 'erbium, chromium:ytrium-scandium-gallium-garnet (ER,CR:YSGG) laser treatment', 'YSGG laser']","['PD, CAL, PI and BoP clinical measurements', 'plaque index (PI), gingival index (GI), probing depth (PD), clinical attachment level (CAL), bleeding on probing (BoP), gingival crevicular fluid (GCF) volume and IL-1β and MMP-8 levels in GCF', 'IL-1 β levels', 'IL-1β and MMP-8 levels', 'clinical parameters']","[{'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0014688', 'cui_str': 'Erbium'}, {'cui': 'C0168430', 'cui_str': 'chromium hexavalent ion'}, {'cui': 'C0036274', 'cui_str': 'Scandium'}, {'cui': 'C0016980', 'cui_str': 'Gallium'}, {'cui': 'C0879167', 'cui_str': 'Yttrium-Scandium-Gallium Garnet Lasers'}]","[{'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017569', 'cui_str': 'Gingival Index'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0021755', 'cui_str': 'T Helper Factor'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",27.0,0.0502073,"There was also a significant reduction in IL-1 β levels in both groups at baseline versus those 1, 3 and 6 months later (p < 0.05)","[{'ForeName': 'Dilara', 'Initials': 'D', 'LastName': 'Sezen', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, University of Akdeniz, Antalya, Turkey.'}, {'ForeName': 'Mükerrem', 'Initials': 'M', 'LastName': 'Hatipoğlu', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, University of Akdeniz, Antalya, Turkey. drmukerremhatipoglu@gmail.com.'}, {'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Üstün', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, University of Akdeniz, Antalya, Turkey.'}]",Lasers in medical science,['10.1007/s10103-020-02990-8']
366,31494365,Time to relapse after a single administration of intravenous ketamine augmentation in unipolar treatment-resistant depression.,"OBJECTIVE


To examine the rate and time to relapse for remitters and responders to ketamine in treatment-resistant depression (TRD).
METHODS


Subjects with TRD were randomized to a single infusion of one of several doses of intravenous ketamine, or midazolam. Using Kaplan-Meier survival function, the current report examines the rate and time to relapse, defined as MADRS ≥ 22, over a period of 30 days, in subjects who achieved remission (MADRS ≤ 10) or response (≥ 50% reduction in MADRS) on day three post-infusion of intravenous ketamine 0.1, 0.5, or 1.0 mg/kg.
RESULTS


Of the 60 randomized participants who received a single ketamine (0.1, 0.5, or 1.0 mg/kg) infusion, 19 (34%) met criteria for remission and 27 (48%) for response, on day 3 post-infusion. A numerical dose-response relationship was observed, with remitters/responders on ketamine 1.0 mg/kg having the lowest relapse rate, followed by ketamine 0.5 mg/kg and 0.1 mg/kg, respectively (% of remitters who relapsed by day 14: 38% with 1.0 mg/kg, 50% with 0.5 mg/kg, 100% with 0.1 mg/kg;% of responders who relapsed by day 14: 30% with 1.0 mg/kg, 50% with 0.5 mg/kg, 80% with 0.1 mg/kg).
LIMITATIONS


The sample size was small. No MADRS measurements at day one post-infusion. The study was not powered to assess differences in relapse prevention between different doses of ketamine.
CONCLUSION


Time to relapse after successful treatment with a single infusion of ketamine appears to follow a dose-response relationship, where higher dosage leads to increased time to relapse.",2020,"A numerical dose-response relationship was observed, with remitters/responders on ketamine 1.0 mg/kg having the lowest relapse rate, followed by ketamine 0.5 mg/kg and 0.1 mg/kg, respectively (% of remitters who relapsed by day 14: 38% with 1.0 mg/kg, 50% with 0.5 mg/kg, 100% with 0.1 mg/kg;% of responders who relapsed by day 14: 30% with 1.0 mg/kg, 50% with 0.5 mg/kg, 80% with 0.1 mg/kg).
","['Subjects with TRD', 'unipolar treatment-resistant depression']","['ketamine', 'ketamine, or midazolam', 'single ketamine']","['relapse prevention', 'rate and time to relapse']","[{'cui': 'C0443340', 'cui_str': 'Unipolar (qualifier value)'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0679867', 'cui_str': 'Relapse Prevention'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",60.0,0.150738,"A numerical dose-response relationship was observed, with remitters/responders on ketamine 1.0 mg/kg having the lowest relapse rate, followed by ketamine 0.5 mg/kg and 0.1 mg/kg, respectively (% of remitters who relapsed by day 14: 38% with 1.0 mg/kg, 50% with 0.5 mg/kg, 100% with 0.1 mg/kg;% of responders who relapsed by day 14: 30% with 1.0 mg/kg, 50% with 0.5 mg/kg, 80% with 0.1 mg/kg).
","[{'ForeName': 'Naji C', 'Initials': 'NC', 'LastName': 'Salloum', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, USA; Clinical Trials Network and Institute, Massachusetts General Hospital, USA. Electronic address: nchaayasalloum@mgh.harvard.edu.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, USA; Clinical Trials Network and Institute, Massachusetts General Hospital, USA.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Hock', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, USA.'}, {'ForeName': 'Marlene P', 'Initials': 'MP', 'LastName': 'Freeman', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, USA; Clinical Trials Network and Institute, Massachusetts General Hospital, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, USA; Clinical Trials Network and Institute, Massachusetts General Hospital, USA.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Hoeppner', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cusin', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'New York University School of Medicine, Nathan Kline Institute, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'The University of Texas Southwestern Medical Center, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'Yale School of Medicine, USA.'}, {'ForeName': 'Sanjay J', 'Initials': 'SJ', 'LastName': 'Mathew', 'Affiliation': 'Baylor College of Medicine and Michael E. Debakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Debattista', 'Affiliation': 'Stanford University School of Medicine, USA.'}, {'ForeName': 'Dawn F', 'Initials': 'DF', 'LastName': 'Ionescu', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, USA.'}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, USA; Clinical Trials Network and Institute, Massachusetts General Hospital, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2019.09.017']
367,31574261,Effect of Lavender Oil Inhalation on Reducing Presurgical Anxiety in Orthognathic Surgery Patients.,"PURPOSE


We hypothesized that lavender oil inhalation, before orthognathic surgery, would have an anxiolytic effect on patients.
MATERIALS AND METHODS


We executed a single-blinded, randomized, prospective study. The study comprised 90 patients (43 men and 47 women) scheduled to undergo orthognathic surgery (bilateral sagittal split, Le Fort I, and bimaxillary osteotomies). The patients were exposed to different concentrations of lavender oil diffusions in 120 mL of water during a 1-hour period before surgery (group 1, 0.1-mL oil diffusion; group 2, 0.3-mL oil diffusion; and group 3, no oil). The predictor variable was the State-Trait Anxiety Inventory (STAI). The STAI-2 was used to assess trait anxiety scores, and the STAI-1 was used to assess state anxiety scores at the time of admittance (STAI-1-A) and after 1 hour, before operating room transfer (STAI-1-OR). We performed a χ 2  analysis for categorical variables, 1-way analysis of variance for continuous variables, and paired-samples t test for patients' state and trait anxiety levels. The P value was set at .05.
RESULTS


No significant differences were found between groups concerning gender, age, working status, educational background, and surgical operation to be performed. When the demographic data and STAI scores were compared, the STAI-2 scores of patients in group 3 aged between 18 and 30 years and high school graduates were significantly higher. The mean trait anxiety scores were significantly higher in group 2 than in group 1. The STAI-1-OR scores in all 3 groups were significantly higher than the STAI-1-A scores. However, no statistically significant difference was found between the groups.
CONCLUSIONS


The results of this study suggested that 1 hour of presurgical inhalation of 0.1-mL and 0.3-mL lavender oil diffusions in 120 mL of water did not have an anxiolytic effect on patients undergoing orthognathic surgery. Future studies will focus on different concentrations, different inhalation times, and higher study samples.",2019,The STAI-1-OR scores in all 3 groups were significantly higher than the STAI-1-A scores.,"['patients undergoing orthognathic surgery', '90 patients (43 men and 47 women) scheduled to undergo', 'Orthognathic Surgery Patients']","['Lavender Oil Inhalation', 'orthognathic surgery (bilateral sagittal split, Le Fort I, and bimaxillary osteotomies', 'lavender oil inhalation', 'lavender oil diffusions in 120\xa0mL of water during a 1-hour period before surgery (group 1, 0.1-mL oil diffusion; group 2, 0.3-mL oil diffusion; and group 3, no oil']","['state anxiety scores', 'STAI-1-OR scores', 'trait anxiety scores', 'mean trait anxiety scores', 'demographic data and STAI scores', 'State-Trait Anxiety Inventory (STAI', 'anxiolytic effect', 'Presurgical Anxiety', 'STAI-2 scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0064694', 'cui_str': 'lavender oil'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205129', 'cui_str': 'Sagittal (qualifier value)'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3179404', 'cui_str': 'Antianxiety Effects'}]",90.0,0.0388063,The STAI-1-OR scores in all 3 groups were significantly higher than the STAI-1-A scores.,"[{'ForeName': 'Poyzan', 'Initials': 'P', 'LastName': 'Bozkurt', 'Affiliation': 'Instructor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Ankara University, Ankara, Turkey. Electronic address: poyzanbozkurt@hotmail.com.'}, {'ForeName': 'Çağıl', 'Initials': 'Ç', 'LastName': 'Vural', 'Affiliation': 'Specialist, Anaesthesiology Division, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Ankara University, Ankara, Turkey.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.08.022']
368,31574262,Comparison of the Performance of Mask Ventilation Between Face Masks With and Without Air Cushion.,"PURPOSE


Mask ventilation is a basic technique for induction of anesthesia. In head and neck surgery, we have encountered difficulty in ventilation owing to facial deformities. Recently, a new type of face mask without an air cushion, the QuadraLite face mask (Intersurgical, Berkshire, UK), was developed. The aim of this study was to compare the performance of cases with predicted difficult mask ventilation between the new type of face mask and a traditional face mask.
PATIENTS AND METHODS


This study was a crossover prospective study. The participants were patients (aged > 18 years) who underwent oral-maxillofacial surgery under general anesthesia. The risk factors for a difficult airway were assessed. Patients were divided into 3 risk groups: low risk, 0 or 1 risk factor for predicted difficult mask ventilation; medium risk, 2 or 3 risk factors; and high risk, 4 or more risk factors. An air cushion face mask (Koo Medical, Shanghai, China) and the QuadraLite face mask were applied in turn under the setting of pressure-controlled ventilation. The expiratory tidal volumes were compared between these face masks.
RESULTS


A total of 48 patients were included: 16 in the low-risk group, 16 in the medium-risk group, and 16 in the high-risk group. Higher expiratory tidal volumes were observed with the QuadraLite face mask than with the air cushion face mask, although the differences did not reach the statistically significant level: 574.3 ± 62.7 mL versus 553.1 ± 60.6 mL in the low-risk group (P = .44), 553.1 ± 112.9 mL versus 536.4 ± 114.2 mL in the medium-risk group (P = .38), and 560.0 ± 98.6 mL versus 548.2 ± 07.1 mL in the high-risk group (P = .22). In all cases, a sufficient ventilation volume was obtained by the QuadraLite face mask.
CONCLUSIONS


The QuadraLite face mask is compact because there is no air cushion, and it can provide sufficient mask ventilation as well as a traditional face mask with an air cushion even in patients with a difficult airway.",2019,"Higher expiratory tidal volumes were observed with the QuadraLite face mask than with the air cushion face mask, although the differences did not reach the statistically significant level: 574.3 ± 62.7 mL versus 553.1 ± 60.6 mL in the low-risk group (P = .44), 553.1 ± 112.9 mL versus 536.4 ± 114.2 ","['patients with a difficult airway', '07.1', 'participants were patients (aged\xa0>\xa018\xa0years) who underwent oral-maxillofacial surgery under general anesthesia', '48 patients were included: 16 in the low-risk group, 16 in the medium-risk group, and 16 in the high-risk group']","['Mask Ventilation Between Face Masks With and Without Air Cushion', 'air cushion face mask ']","['Higher expiratory tidal volumes', 'expiratory tidal volumes', 'sufficient ventilation volume']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038908', 'cui_str': 'Surgery, Maxillofacial'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0180823', 'cui_str': 'Face mask (physical object)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0180249', 'cui_str': 'Cushion'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3698222', 'cui_str': 'Expiratory tidal volume'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",48.0,0.0184301,"Higher expiratory tidal volumes were observed with the QuadraLite face mask than with the air cushion face mask, although the differences did not reach the statistically significant level: 574.3 ± 62.7 mL versus 553.1 ± 60.6 mL in the low-risk group (P = .44), 553.1 ± 112.9 mL versus 536.4 ± 114.2 ","[{'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Tsukamoto', 'Affiliation': 'Assistant Professor, Department of Dental Anesthesiology, Kyushu University Hospital, Fukuoka, Japan. Electronic address: tsukamoto@dent.kyushu-u.ac.jp.'}, {'ForeName': 'Shiori', 'Initials': 'S', 'LastName': 'Taura', 'Affiliation': 'Graduate Student, Department of Dental Anesthesiology, Graduate School of Dental Science, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Hitosugi', 'Affiliation': 'Assistant Professor, Department of Dental Anesthesiology, Faculty of Dental Science, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Yokoyama', 'Affiliation': 'Professor, Department of Dental Anesthesiology, Faculty of Dental Science, Kyushu University, Fukuoka, Japan.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.08.025']
369,32207217,The effect of adaptation theory-based therapeutic approach on adolescents anger management.,"PROBLEM


Anger is usually defined as psychometric, rather than a theoretical model and generally, anger treatments have been developed for handling incompatible anger. Roy Adaptation Model-based intervention not only focuses on problematic behaviors but also on healthy behaviors and to evaluate the individual with a holistic perspective. The research aim was the examination of the effect of the Roy adaptation theory-based, cognitive-behavioral approach program on adolescent's anger management.
METHODS


In this study, the pretest-posttest control group experimental design, interview, and observation techniques were used. Carried out in a vocational training center, with 60 participants (experimental group 30 and control group 30), who meet the research criteria. The semi-structured interview forms, the state-trait anger expression inventory, multidimensional anger scale, and brief symptom inventory were used for data collection. Results have been evaluated to the 95% confidence interval and p < .05 significance level. In data analysis; descriptive statistics, Pearson's χ 2  test, Mann-Whitney U test, and Wilcoxon Sign tests were used.
FINDINGS


There was a significant difference in anger management levels of the experimental group after the adaptation theory-based therapeutic approach program.
CONCLUSION


Study results showed that the adaptation-base therapeutic approach is effective in adolescent's anger management. This program will contribute to theoretical and practical studies and field experts.",2020,"There was a significant difference in anger management levels of the experimental group after the adaptation theory-based therapeutic approach program.
","[""adolescent's anger management"", 'adolescents anger management']","['Roy adaptation theory-based, cognitive-behavioral approach program', 'adaptation theory-based therapeutic approach', 'Roy Adaptation Model-based intervention']",['anger management levels'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0557992', 'cui_str': 'Anger Management Training'}]","[{'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0557992', 'cui_str': 'Anger Management Training'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0187487,"There was a significant difference in anger management levels of the experimental group after the adaptation theory-based therapeutic approach program.
","[{'ForeName': 'Satı', 'Initials': 'S', 'LastName': 'Doğan', 'Affiliation': 'Department of Psychiatric Mental Health Nursing, Faculty of Nursing, Izmir, Turkey.'}, {'ForeName': 'Olcay', 'Initials': 'O', 'LastName': 'Çam', 'Affiliation': 'Department of Psychiatric Mental Health Nursing, Faculty of Nursing, Izmir, Turkey.'}]","Journal of child and adolescent psychiatric nursing : official publication of the Association of Child and Adolescent Psychiatric Nurses, Inc",['10.1111/jcap.12268']
370,30277500,"Semiannual Versus Annual Influenza Vaccination in Older Adults in the Tropics: An Observer-blind, Active-comparator-controlled, Randomized Superiority Trial.","BACKGROUND


Antibody titres and vaccine effectiveness decline within 6 months after influenza vaccination in older adults. Biannual vaccination may be necessary to provide year-round protection in the tropics, where influenza circulates throughout the year.
METHODS


Tropical Influenza Control Strategies (TROPICS1) was a single-center, 1:1 randomized, observer-blinded, active-comparator-controlled, superiority study in 200 community-resident adults aged ≥65 years. Participants received a standard-dose trivalent inactivated influenza vaccination (IIV3) at enrollment, and either tetanus-diphtheria-pertussis vaccination or IIV3 6 months later. The primary outcome was the proportion of participants with haemagglutination-inhibition (HI) geometric mean titre (GMT) ≥1:40 1 month after the second vaccination (month 7). Secondary outcomes included GMTs to month 12, the incidence of influenza-like illness (ILI), and adverse reactions after vaccination.
RESULTS


At month 7, the proportion of participants with an HI tire ≥1:40 against A/H1N1 increased by 21.4% (95% confidence interval [CI] 8.6-33.4) in the semiannual vaccination group. This proportion was not significantly higher for A/H3N2 (4.3, 95% CI -1.1-10.8) or B (2.1, 95% CI -2.0-7.3). Semiannual vaccination significantly increased GMTs against A/H1N1 and A/H3N2, but not B, at month 7. Participants receiving a repeat vaccination of IIV3 reported a significantly lower incidence of ILI in the 6 months after the second vaccination (relative vaccine effectiveness 57.1%, 95% CI 0.6-81.5). The frequency of adverse events was similar after the first and second influenza vaccinations.
CONCLUSIONS


Semiannual influenza vaccination in older residents of tropical countries has the potential to improve serological measures of protection against infection. Alternative vaccination strategies should also be studied.
CLINICAL TRIALS REGISTRATION


NCT02655874.",2019,"Semiannual vaccination significantly increased GMTs against A/H1N1 and A/H3N2, but not B, at month 7.","['200 community-resident adults aged ≥65 years', 'Older Adults in the Tropics', 'older residents of tropical countries', 'older adults']","['Semiannual Versus Annual Influenza Vaccination', 'standard-dose trivalent inactivated influenza vaccination (IIV3) at enrollment, and either tetanus-diphtheria-pertussis vaccination or IIV3 6 months later']","['GMTs to month 12, the incidence of influenza-like illness (ILI), and adverse reactions after vaccination', 'proportion of participants with haemagglutination-inhibition (HI) geometric mean titre (GMT', 'frequency of adverse events', 'incidence of ILI']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0042203', 'cui_str': 'Pertussis vaccination (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0521839', 'cui_str': 'Influenza-like illness (finding)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",200.0,0.337966,"Semiannual vaccination significantly increased GMTs against A/H1N1 and A/H3N2, but not B, at month 7.","[{'ForeName': 'Barnaby', 'Initials': 'B', 'LastName': 'Young', 'Affiliation': 'National Centre for Infectious Diseases.'}, {'ForeName': 'Sapna', 'Initials': 'S', 'LastName': 'Sadarangani', 'Affiliation': 'National Centre for Infectious Diseases.'}, {'ForeName': 'Sen Yew', 'Initials': 'SY', 'LastName': 'Haur', 'Affiliation': 'National Centre for Infectious Diseases.'}, {'ForeName': 'Chee Fu', 'Initials': 'CF', 'LastName': 'Yung', 'Affiliation': ""Infectious Disease Service, KK Women's and Children's Hospital, Singapore.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Barr', 'Affiliation': 'World Health Organization Collaborating Centre for Reference and Research on Influenza, Melbourne.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Connolly', 'Affiliation': 'Lee Kong Chian School of Medicine, Nanyang Technological University.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'National Centre for Infectious Diseases.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Wilder-Smith', 'Affiliation': 'Lee Kong Chian School of Medicine, Nanyang Technological University.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy836']
371,30281074,"Locking Hemodialysis Catheters With Trimethoprim-Ethanol-Ca-EDTA to Prevent Bloodstream Infections: A Randomized, Evaluator-blinded Clinical Trial.","BACKGROUND


Central line-associated bloodstream infections (CLABSIs) often result from intraluminal microbial colonization and are associated with morbidity, mortality, and substantial costs. The use of antimicrobial catheter lock solutions may reduce the incidence of CLABSI.
METHODS


Patients undergoing hemodialysis (HD) through a prevalent central venous catheter (CVC) were randomly assigned to have their CVC locked between dialysis sessions with an antimicrobial catheter lock solution that contained trimethoprim 5 mg/mL, ethanol 25%, and Ca-EDTA 3% (investigational medical device [IMD]) or heparin 5000 U/mL active control heparin (ACH). Exit site care was standardized by protocol-driven use of skin antiseptics and occlusive dressings. The composite primary endpoint consisted of the incidence of CLABSI and intracatheter thrombolytic treatment (TT). Given the viscosity and odor of the IMD, blinding was impossible. Therefore, a blinded endpoint committee adjudicated the incidence of CLABSI.
RESULTS


A total of 270 patients on HD were enrolled and followed for 43738 CVC-days. Despite the low CLABSI incidence of 0.41/1000 CVC-days in patients randomized to ACH, the IMD further reduced the incidence 4.56-fold to 0.09/1000 CVC-days (P < .03). The product was well tolerated, and the frequency and severity of adverse events were comparable between groups. Intracatheter instillation of thrombolytics was more frequent in patients who received the IMD (12% ACH, 40% IMD; P < .001), but rates of catheter removal did not differ (13% ACH, 11% IMD). Overall, dialysis adequacy was comparable between groups.
CONCLUSIONS


In patients on chronic HD, a trimethoprim, ethanol, and Ca-EDTA lock solution significantly reduced the incidence of CLABSI.
CLINICAL TRIALS REGISTRATION


NCT01989091.",2019,"The product was well tolerated, and the frequency and severity of adverse events were comparable between groups.","['Patients undergoing hemodialysis (HD) through a prevalent central venous catheter (CVC', '270 patients on HD were enrolled and followed for 43738 CVC-days']","['U/mL active control heparin (ACH', 'CVC locked between dialysis sessions with an antimicrobial catheter lock solution that contained trimethoprim 5 mg/mL, ethanol 25%, and Ca-EDTA 3% (investigational medical device [IMD]) or heparin 5000', 'ACH', 'trimethoprim, ethanol, and Ca-EDTA lock solution', 'antimicrobial catheter lock solutions', 'Trimethoprim-Ethanol-Ca-EDTA']","['Overall, dialysis adequacy', 'frequency and severity of adverse events', 'rates of catheter removal', 'Bloodstream Infections', 'incidence of CLABSI and intracatheter thrombolytic treatment (TT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C1145640', 'cui_str': 'Central Venous Catheters'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C2945590', 'cui_str': 'unit/mL'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0041041', 'cui_str': 'Trimethoprim'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C0529584', 'cui_str': 'isothiocyanatobenzyl-EDTA'}, {'cui': 'C0025080', 'cui_str': 'Medical Devices'}, {'cui': 'C4319610', 'cui_str': '5000 (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter (procedure)'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0016018', 'cui_str': 'Fibrinolytic Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",270.0,0.135443,"The product was well tolerated, and the frequency and severity of adverse events were comparable between groups.","[{'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Rijnders', 'Affiliation': 'Erasmus University Medical Center Rotterdam, The Netherlands.'}, {'ForeName': 'Gino J', 'Initials': 'GJ', 'LastName': 'DiSciullo', 'Affiliation': 'Prevacept Infection Control, Inc., Broomfield, Colorado.'}, {'ForeName': 'Botond', 'Initials': 'B', 'LastName': 'Csiky', 'Affiliation': 'FMC Dialízis Központ Pécs, Hungary.'}, {'ForeName': 'Bolesław', 'Initials': 'B', 'LastName': 'Rutkowski', 'Affiliation': 'Uniwersyteckie Centrum Kliniczne, Klinika Nefrologii, Gdansk, Poland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Appelt', 'Affiliation': 'Prevacept Infection Control, Inc., Broomfield, Colorado.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Cheronis', 'Affiliation': 'Prevacept Infection Control, Inc., Broomfield, Colorado.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Aitchison', 'Affiliation': 'Prevacept Infection Control, Inc., Broomfield, Colorado.'}, {'ForeName': 'Gilad', 'Initials': 'G', 'LastName': 'Gordon', 'Affiliation': 'Prevacept Infection Control, Inc., Broomfield, Colorado.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Jadoul', 'Affiliation': 'Cliniques Universitaires Saint-Luc Service De Nephrologie, Bruxelles, Belgium.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fluck', 'Affiliation': 'Department of Renal Medicine, Royal Derby Hospital,Derby,United Kingdom.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy840']
372,32192537,Effects of low- and high-intensity physical exercise on physical and cognitive function in older persons with dementia: a randomized controlled trial.,"BACKGROUND


Potential moderators such as exercise intensity or apolipoprotein-E4 (ApoE4) carriership may determine the magnitude of exercise effects on physical and cognitive functions in patients with dementia (PwD). We determined the effects of a 24-week aerobic and strength training program with a low- and high-intensity phase on physical and cognitive function.
METHODS


In an assessor-blinded randomized trial, 91 PwD (all-cause dementia, recruited from daycare and residential care facilities, age 82.3 ± 7.0 years, 59 women, Mini-Mental State Examination 20.2 ± 4.4) were allocated to the exercise or control group. In the exercise group, PwD participated in a walking and lower limb strength training program with 12 weeks low- and 12 weeks high-intensity training offered three times/week. Attention-matched control participants performed flexibility exercises and recreational activities. We assessed adherence, compliance, and exercise intensity for each session. We assessed physical (endurance, gait speed, mobility, balance, leg strength) and cognitive (verbal memory, visual memory, executive function, inhibitory control, psychomotor speed) functions with performance-based tests at baseline and after 6, 12, 18, 24, and 36 weeks (follow-up). ApoE4 carriership was determined post-intervention.
RESULTS


Sixty-nine PwD were analyzed. Their mean attendance was ~ 60% during the study period. There were no significant effects of the exercise vs. control intervention on endurance, mobility, balance, and leg strength in favor of the exercise group (Cohen's d = 0.13-0.18). Gait speed significantly improved with ~ 0.05 m/s after the high-intensity phase for exercise participants (Cohen's d = 0.41) but declined at follow-up. There were no significant effects of the exercise vs. control intervention on any of the cognitive measures (Cohen's d ~ - 0.04). ApoE4 carriership did not significantly moderate exercise effects on physical or cognitive function.
CONCLUSIONS


Exercise was superior to control activities for gait speed in our sample of PwD. However, the training effect provided no protection for mobility loss after detraining (follow-up). There were no beneficial effects of the exercise vs. control group on cognitive function. Exercise intensity moderated the effects of exercise on gait speed. ApoE4 carriership moderated the effect of exercise on global cognition only (trend level).
TRIAL REGISTRATION


Netherlands Trial Register, NTR5035. Registered on 2 March 2015.",2020,"There were no significant effects of the exercise vs. control intervention on endurance, mobility, balance, and leg strength in favor of the exercise group (Cohen's d = 0.13-0.18).","['patients with dementia (PwD', '91 PwD (all-cause dementia, recruited from daycare and residential care facilities, age 82.3\u2009±\u20097.0\xa0years, 59 women, Mini-Mental State Examination 20.2\u2009±\u20094.4', 'older persons with dementia']","['24-week aerobic and strength training program', 'low- and high-intensity physical exercise', 'exercise or control group']","['cognitive function', 'Gait speed', 'mean attendance', 'endurance, mobility, balance, and leg strength', 'mobility loss', 'global cognition', 'physical (endurance, gait speed, mobility, balance, leg strength) and cognitive (verbal memory, visual memory, executive function, inhibitory control, psychomotor speed) functions with performance-based tests', 'adherence, compliance, and exercise intensity', 'gait speed', 'physical and cognitive function', 'flexibility exercises and recreational activities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C4517642', 'cui_str': '20.2 (qualifier value)'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0542316', 'cui_str': 'Visual memory (observable entity)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",69.0,0.025569,"There were no significant effects of the exercise vs. control intervention on endurance, mobility, balance, and leg strength in favor of the exercise group (Cohen's d = 0.13-0.18).","[{'ForeName': 'L M J', 'Initials': 'LMJ', 'LastName': 'Sanders', 'Affiliation': 'Center for Human Movement Sciences, University of Groningen, University Medical Center Groningen, Antonius Deusinglaan 1, 9713 AV, Groningen, The Netherlands. l.m.j.sanders@umcg.nl.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hortobágyi', 'Affiliation': 'Center for Human Movement Sciences, University of Groningen, University Medical Center Groningen, Antonius Deusinglaan 1, 9713 AV, Groningen, The Netherlands.'}, {'ForeName': 'E G A', 'Initials': 'EGA', 'LastName': 'Karssemeijer', 'Affiliation': 'Department of Geriatric Medicine, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Van der Zee', 'Affiliation': 'Groningen Institute for Evolutionary Life Sciences (GELIFES), University of Groningen, Nijenborgh 7, 9747 AG, Groningen, The Netherlands.'}, {'ForeName': 'E J A', 'Initials': 'EJA', 'LastName': 'Scherder', 'Affiliation': 'Department of Clinical Neuropsychology, VU University Amsterdam, Van der Boechorststraat 1, 1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'M J G', 'Initials': 'MJG', 'LastName': 'van Heuvelen', 'Affiliation': 'Center for Human Movement Sciences, University of Groningen, University Medical Center Groningen, Antonius Deusinglaan 1, 9713 AV, Groningen, The Netherlands.'}]",Alzheimer's research & therapy,['10.1186/s13195-020-00597-3']
373,31228427,Does Sub-Anesthetic Ketamine Provide Postoperative Analgesia for Third Molar Surgery?,"PURPOSE


Despite ketamine's effectiveness as an anesthetic and its known analgesic properties, the role of ketamine in postoperative pain after third molar surgery remains unclear. Therefore, this study aimed to investigate whether patients undergoing third molar surgery who received a sub-anesthetic preoperative dose of intravenous ketamine would experience less postoperative pain.
MATERIALS AND METHODS


We implemented a randomized, double-blinded, placebo-controlled trial. The study sample consisted of participants undergoing third molar surgery with procedural sedation anesthesia. Participants were randomized to receive a preoperative intravenous dose of ketamine or placebo, as predictor variables. The primary outcome variable was postoperative pain intensity determined by a 10-point visual analog scale at 6-hour intervals over a period of 48 hours. The secondary outcome variable was the quantity of postoperative non-opioid and opioid consumption. Other variables included the extent and difficulty of surgery performed, patient satisfaction, gender, and age. Data analysis involved descriptive statistics, multivariate analysis, and regression analysis. The P value was set at .05.
RESULTS


A total of 134 participants were randomly enrolled into either the ketamine group (n = 74, 55.2%) or placebo group (n = 60, 44.8%). No statistically significant differences in the distribution of study variables were found between the groups. A small yet statistically significant (P < .05) difference was noted in the median pain score at 6 hours postoperatively, with the ketamine group experiencing more pain. However, no further differences were detected at any postoperative time between the 2 groups. Similar results were obtained after adjusting for age, gender, and surgical difficulty. No difference in the amount of postoperative non-opioid or opioid medication use was found between the 2 groups.
CONCLUSIONS


This study did not find evidence that a preoperative sub-anesthetic dose of ketamine could reduce pain after third molar surgery or have any effects on non-opioid or opioid analgesic consumption. Nevertheless, ketamine remains a valuable option among sedation medications for oral and maxillofacial surgeons.",2019,"A small yet statistically significant (P < .05) difference was noted in the median pain score at 6 hours postoperatively, with the ketamine group experiencing more pain.","['A total of 134 participants', 'participants undergoing third molar surgery with procedural sedation anesthesia', 'patients undergoing third molar surgery']","['ketamine', 'ketamine or placebo', 'placebo']","['pain', 'postoperative time', 'amount of postoperative non-opioid or opioid medication use', 'quantity of postoperative non-opioid and opioid consumption', 'median pain score', 'postoperative pain intensity determined by a 10-point visual analog scale']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",134.0,0.665527,"A small yet statistically significant (P < .05) difference was noted in the median pain score at 6 hours postoperatively, with the ketamine group experiencing more pain.","[{'ForeName': 'Johnson', 'Initials': 'J', 'LastName': 'Cheung', 'Affiliation': 'Resident, Department of Oral & Maxillofacial Surgery, Dalhousie University, Halifax, Nova Scotia, Canada. Electronic address: johnson.cheung@dal.ca.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Alashi', 'Affiliation': 'Dental Student, Faculty of Dentistry, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Prosper', 'Initials': 'P', 'LastName': 'Koto', 'Affiliation': 'Health Economist, Research Methods Unit, Centre for Clinical Research, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Brady', 'Affiliation': 'Staff Surgeon, Department of Oral & Maxillofacial Surgery, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Davis', 'Affiliation': 'Dean and Professor in Oral and Maxillofacial Surgery, Faculty of Dentistry, Dalhousie University, Halifax, Nova Scotia, Canada.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.05.009']
374,31344339,Alveolar Iodine Tampon Packing Reduces Postoperative Morbidity After Third Molar Surgery.,"PURPOSE


The aim of this study was to assess the efficacy of an iodine tampon after mandibular third molar surgery on oral health-related quality of life (OHRQoL), use of painkillers, postoperative sequelae, and self-care behaviors in the first postoperative week.
MATERIALS AND METHODS


This prospective, crossover, randomized controlled study included patients undergoing surgical removal of bilateral symmetrically, horizontally impacted mandibular third molars. The surgical site was randomly allocated to receive an iodine tampon after surgery or wound closure and rinsing with a Monoject syringe (Tyco/Healthcare-Kendall, Mansfield, MA). The primary outcomes measured each day during the first postoperative week were the Oral Health Impact Profile 14 score and postoperative sequelae, including pain, swelling, limited mouth opening, postoperative infection, and alveolar osteitis. The secondary outcome measures were several self-care behaviors. Data were analyzed using repeated-measures analysis of variance and paired-samples t tests.
RESULTS


A total of 54 patients (25 men and 29 women; mean age, 25.1 years) were enrolled, with a total of 108 surgically removed impacted mandibular third molars. The use of an iodine tampon resulted in a significantly lower impact on OHRQoL (mean of 21.5 [standard deviation (SD), 9.6] vs 26.5 [SD, 10.6]) on the first postoperative day, which was observable until the seventh postoperative day. In addition, after removal of the impacted third molar, patients with the iodine tampon condition reported less pain (mean of 5.2 [SD, 1.9] vs 6.1 [SD, 2.1] on day 1, lasting throughout the week), less use of painkillers, less limited mouth opening, fewer problems chewing, less swelling, and earlier recovery.
CONCLUSIONS


The use of postoperative iodine packing after the removal of impacted mandibular third molars significantly reduces OHRQoL and postoperative sequelae.",2019,The use of an iodine tampon resulted in a significantly lower impact on OHRQoL,"['patients undergoing surgical removal of bilateral symmetrically, horizontally impacted mandibular third molars', '54 patients (25 men and 29 women; mean age, 25.1\xa0years) were enrolled, with a total of 108 surgically removed impacted mandibular third molars']","['iodine tampon after surgery or wound closure and rinsing with a Monoject syringe (Tyco/Healthcare-Kendall, Mansfield, MA', 'iodine tampon', 'postoperative iodine packing', 'Alveolar Iodine Tampon Packing']","['oral health-related quality of life (OHRQoL), use of painkillers, postoperative sequelae, and self-care behaviors', 'OHRQoL', 'pain', 'Oral Health Impact Profile 14 score and postoperative sequelae, including pain, swelling, limited mouth opening, postoperative infection, and alveolar osteitis', 'OHRQoL and postoperative sequelae', 'limited mouth opening, fewer problems chewing, less swelling, and earlier recovery', 'several self-care behaviors', 'Postoperative Morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C1883720', 'cui_str': 'Removes'}]","[{'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C1704612', 'cui_str': 'Tampon (basic dose form)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure (attribute)'}, {'cui': 'C0184957', 'cui_str': 'Irrigation with syringe (procedure)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}]","[{'cui': 'C0029162'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0243088', 'cui_str': 'sequelae'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0392618', 'cui_str': 'Postoperative infection (disorder)'}, {'cui': 'C0013240', 'cui_str': 'Alveolitis Sicca Dolorosa'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0699816', 'cui_str': 'Does chew (finding)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",108.0,0.229194,The use of an iodine tampon resulted in a significantly lower impact on OHRQoL,"[{'ForeName': 'Jacco G', 'Initials': 'JG', 'LastName': 'Tuk', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Academic Medical Center, Amsterdam, and Private Practice, Amstelland Hospital, Amstelveen, The Netherlands.'}, {'ForeName': 'Jerome A', 'Initials': 'JA', 'LastName': 'Lindeboom', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Academic Medical Center, Amsterdam, and Private Practice, Amstelland Hospital, Amstelveen, The Netherlands. Electronic address: j.a.lindeboom@amc.uva.nl.'}, {'ForeName': 'Faro', 'Initials': 'F', 'LastName': 'Sana', 'Affiliation': 'Dental Student, Department of Oral and Maxillofacial Surgery, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Arjen J', 'Initials': 'AJ', 'LastName': 'van Wijk', 'Affiliation': 'Associate Professor, Department of Social Dentistry, Academic Centre for Dentistry Amsterdam, University of Amsterdam, and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Dan M J', 'Initials': 'DMJ', 'LastName': 'Milstein', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Academic Medical Center, Amsterdam, The Netherlands.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.06.175']
375,32212009,Effect of phenytoin on retinal ganglion cells in acute isolated optic neuritis.,"OBJECTIVE


Phenytoin has been shown to reduce the peripapillary retinal nerve fiber layer (pRNFL) loss in optic neuritis (ON). We evaluated the effects of phenytoin on retinal ganglion layers and visual outcomes of newly diagnosed acute ON.
METHODS


A randomized, placebo-controlled trial was conducted in a tertiary referral eye hospital and patients with the first episode of typical demyelinating ON, without any history of multiple sclerosis were randomly assigned to phenytoin or placebo. The thickness of ganglion cell-inner plexiform layer (GCIPL) measured by optical coherence tomography (OCT) was considered as the primary outcome.
RESULTS


One patient in the phenytoin group developed severe cutaneous rashes that progressed to Stevens-Johnson syndrome (SJS)/toxic epidermal necrosis (TEN), and further allocation of patients to the phenytoin group was stopped, and finally fifteen participants were included in the phenytoin group. Fifty-one patients were enrolled to the placebo group, from which four were excluded. Both visual acuity and field were not significantly different between the control and phenytoin groups after 1 and 6 months. Mean 3- and 6-mm macular GCIPL thicknesses decreased after 6 months to 73.6 ± 14.1 and 57.9 ± 7.5 μm, respectively, in the phenytoin group and to 71.6 ± 15.7 and 55.6 ± 6.6 μm, respectively, in the placebo group with no significant differences between the two groups (P = 0.77 and P = 0.26, respectively, linear multilevel model).
CONCLUSION


Phenytoin is not probably safe and effective as neuroprotection after acute ON. Further investigation with other sodium channel inhibitors could be considered.",2020,"Mean 3- and 6-mm macular GCIPL thicknesses decreased after 6 months to 73.6 ± 14.1 and 57.9 ± 7.5 μm, respectively, in the phenytoin group and to 71.6 ± 15.7 and 55.6 ± 6.6 μm, respectively, in the placebo group with no significant differences between the two groups (P = 0.77 and P = 0.26, respectively, linear multilevel model).
","['newly diagnosed acute ON', 'Fifty-one patients were enrolled to the placebo group, from which four were excluded', 'tertiary referral eye hospital and patients with the first episode of typical demyelinating ON, without any history of multiple sclerosis', 'acute isolated optic neuritis']","['sodium channel inhibitors', 'phenytoin', 'Phenytoin', 'placebo', 'phenytoin or placebo']","['retinal ganglion cells', 'thickness of ganglion cell-inner plexiform layer (GCIPL', 'severe cutaneous rashes', 'visual acuity and field', 'Mean 3- and 6-mm macular GCIPL thicknesses', 'retinal ganglion layers and visual outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0029134', 'cui_str': 'Optic Neuritis'}]","[{'cui': 'C0872271', 'cui_str': 'Sodium Channel Inhibitors'}, {'cui': 'C0031507', 'cui_str': 'Phenytoin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035316', 'cui_str': 'Retinal Ganglion Cells'}, {'cui': 'C0228071', 'cui_str': 'Ganglion cell (cell)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0450207', 'cui_str': 'Plexiform (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0017067', 'cui_str': 'Ganglia'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}]",51.0,0.202787,"Mean 3- and 6-mm macular GCIPL thicknesses decreased after 6 months to 73.6 ± 14.1 and 57.9 ± 7.5 μm, respectively, in the phenytoin group and to 71.6 ± 15.7 and 55.6 ± 6.6 μm, respectively, in the placebo group with no significant differences between the two groups (P = 0.77 and P = 0.26, respectively, linear multilevel model).
","[{'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Yadegari', 'Affiliation': 'Farabi Eye Hospital, Tehran University of Medical science, Qazvin Sq, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Gholizade', 'Affiliation': 'Farabi Eye Hospital, Tehran University of Medical science, Qazvin Sq, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Ghahvehchian', 'Affiliation': 'Farabi Eye Hospital, Tehran University of Medical science, Qazvin Sq, Tehran, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Aghsaei Fard', 'Affiliation': 'Farabi Eye Hospital, Tehran University of Medical science, Qazvin Sq, Tehran, Iran. masood219@gmail.com.'}]",Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology,['10.1007/s10072-020-04360-2']
376,31323184,Photobiomodulation Alleviates Postoperative Discomfort After Mandibular Third Molar Surgery.,"PURPOSE


Surgical removal of mandibular third molars is associated with some degree of postoperative pain, trismus, and facial swelling. The purpose of the study was to evaluate the effect of photobiomodulation in reducing these postoperative side effects after surgical removal of mandibular third molars.
MATERIALS AND METHODS


This randomized, double-blinded, split-mouth pilot study was carried out in the Department of Oral and Maxillofacial Surgery, Post Graduate Institute of Dental Sciences, Rohtak, India, among patients with impacted mandibular third molars. In each patient, 1 side was treated by photobiomodulation and the other side received placebo. Photobiomodulation was performed by intraoral and extraoral application of an 830-nm and 30-mW laser at different time points. Pain, trismus, and facial swelling were evaluated at all time points. The number of analgesics taken also was recorded. The data were analyzed using descriptive, bivariate and multivariate statistics.
RESULTS


The study was conducted in 25 patients (56% male patients) with a mean age of 22.16 ± 4.60 years. There were 50 sites divided equally into both groups. The sites treated with photobiomodulation showed a significant reduction in pain and swelling (P < .05) compared with the sites in the placebo group. Moreover, an increase in mouth opening was noted after photobiomodulation compared with that in the placebo group, but this was not statistically significant (P > .05).
CONCLUSIONS


The results of this study suggest that photobiomodulation is effective in reducing pain and swelling after mandibular third molar surgery. Hence, it can be used as an alternative and effective modality after surgical removal of mandibular third molars, thereby improving the quality of life of the patients.",2019,The sites treated with photobiomodulation showed a significant reduction in pain and swelling (P < .05) compared with the sites in the placebo group.,"['Department of Oral and Maxillofacial Surgery, Post Graduate Institute of Dental Sciences, Rohtak, India, among patients with impacted mandibular third molars', '25 patients (56% male patients) with a mean age of 22.16\xa0±\xa04.60\xa0years']","['placebo', 'photobiomodulation']","['number of analgesics taken', 'mouth opening', 'postoperative pain, trismus, and facial swelling', 'pain and swelling', 'Pain, trismus, and facial swelling', 'Photobiomodulation Alleviates Postoperative Discomfort']","[{'cui': 'C0812928', 'cui_str': 'Oral and maxillofacial surgery'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0151602', 'cui_str': 'Facial swelling (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}]",,0.274283,The sites treated with photobiomodulation showed a significant reduction in pain and swelling (P < .05) compared with the sites in the placebo group.,"[{'ForeName': 'Virendra', 'Initials': 'V', 'LastName': 'Singh', 'Affiliation': 'Senior Professor and Head of Department, Department of Oral and Maxillofacial Surgery, Post Graduate Institute of Dental Sciences, Rohtak, India. Electronic address: drvirendrasingh1@gmail.com.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Garg', 'Affiliation': 'Resident, Department of Oral and Maxillofacial Surgery, Post Graduate Institute of Dental Sciences, Rohtak, India.'}, {'ForeName': 'Amrish', 'Initials': 'A', 'LastName': 'Bhagol', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Post Graduate Institute of Dental Sciences, Rohtak, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Savarna', 'Affiliation': 'Physiotherapist, Department of Physiotherapy, Post Graduate Institute of Medical Sciences, Rohtak, India.'}, {'ForeName': 'Santosh Kumar', 'Initials': 'SK', 'LastName': 'Agarwal', 'Affiliation': 'Fellow in Craniomaxillofacial Trauma, Department of Oral and Maxillofacial Surgery, Post Graduate Institute of Dental Sciences, Rohtak, India.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.06.009']
377,32118616,"Enriched, Task-Specific Therapy in the Chronic Phase After Stroke: An Exploratory Study.","BACKGROUND AND PURPOSE


There is a need to translate promising basic research about environmental enrichment to clinical stroke settings. The aim of this study was to assess the effectiveness of enriched, task-specific therapy in individuals with chronic stroke.
METHODS


This is an exploratory study with a within-subject, repeated-measures design. The intervention was preceded by a baseline period to determine the stability of the outcome measures. Forty-one participants were enrolled at a mean of 36 months poststroke. The 3-week intervention combined physical therapy with social and cognitive stimulation inherent to environmental enrichment. The primary outcome was motor recovery measured by Modified Motor Assessment Scale (M-MAS). Secondary outcomes included balance, walking, distance walked in 6 minutes, grip strength, dexterity, and multiple dimensions of health. Assessments were made at baseline, immediately before and after the intervention, and at 3 and 6 months.
RESULTS


The baseline measures were stable. The 39 participants (95%) who completed the intervention had increases of 2.3 points in the M-MAS UAS and 5 points on the Berg Balance Scale (both P < 0.001; SRM >0.90), an improvement of comfortable and fast gait speed of 0.13 and 0.23 m/s, respectively. (P < 0.001; SRM = 0.88), an increased distance walked over 6 minutes (24.2 m; P < 0.001; SRM = 0.64), and significant improvements in multiple dimensions of health. The improvements were sustained at 6 months.
DISCUSSION AND CONCLUSIONS


Enriched, task-specific therapy may provide durable benefits across a wide spectrum of motor deficits and impairments after stroke. Although the results must be interpreted cautiously, the findings have implications for enriching strategies in stroke rehabilitation.Video Abstract available for more insights from the authors (see the Video, Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A304).",2020,"an increased distance walked over 6 minutes (24.2 m; P < 0.001; SRM = 0.64), and significant improvements in multiple dimensions of health.","['Forty-one participants were enrolled at a mean of 36 months poststroke', 'individuals with chronic stroke']","['intervention combined physical therapy with social and cognitive stimulation inherent to environmental enrichment', 'task-specific therapy', 'Task-Specific Therapy']","['improvement of comfortable and fast gait speed', 'balance, walking, distance walked in 6 minutes, grip strength, dexterity, and multiple dimensions of health', 'multiple dimensions of health', 'motor recovery measured by Modified Motor Assessment Scale (M-MAS', 'Berg Balance Scale']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}]","[{'cui': 'C0700642', 'cui_str': 'Combined physical therapy (regime/therapy)'}, {'cui': 'C0150174', 'cui_str': 'Cognitive stimulation (regime/therapy)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities (observable entity)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451321', 'cui_str': 'Motor assessment scale (assessment scale)'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}]",41.0,0.0507091,"an increased distance walked over 6 minutes (24.2 m; P < 0.001; SRM = 0.64), and significant improvements in multiple dimensions of health.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Vive', 'Affiliation': 'Section for Health and Rehabilitation, Institute of Neuroscience and Physiology, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden (S.V. and L.B-K.); Neurocampus, Sophiahemmet Hospital, Stockholm, Sweden (S.V.); Karolinska Institute Clinical Epidemiology Unit, Department of Medicine, Karolinska Institute, Stockholm, Sweden (J-L.G.); Center for Brain Repair, Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden (H.G.K.); Center for Stroke Research and Neurocure Cluster of Excellence, Charité-Universitätsmedizin, Berlin, Germany (H.G.K.); and Centre for Advanced Reconstruction of Extremities, Sahlgrenska University Hospital, Mölndal, Sweden (L.B-K.).'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Af Geijerstam', 'Affiliation': ''}, {'ForeName': 'H Georg', 'Initials': 'HG', 'LastName': 'Kuhn', 'Affiliation': ''}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Bunketorp-Käll', 'Affiliation': ''}]",Journal of neurologic physical therapy : JNPT,['10.1097/NPT.0000000000000309']
378,32130146,Undergraduate Medical Students' Search for Health Information Online: Explanatory Cross-Sectional Study.,"BACKGROUND


Previous research shows that being a ""digital native"" or growing up in a digital environment does not necessarily lead to increased digital competencies, such as digital health literacy or evaluation of webpage quality.
OBJECTIVE


This study showed how medical students searched for health information online, specifically the recommended testing for histamine intolerance, by comparing the use of various search engines (Google, Medisuch, and a website of the student's choice) to find out more about search strategies in future health professionals. As Medisuch presents a qualitatively better search engine, we assumed that medical students using this search engine might find valid information faster on more reliable webpages, and might recommend the correct diagnostic steps for histamine intolerance to their patients more often than students using a generic search engine like Google.
METHODS


Medical students in their third year of study were asked to find the relevant diagnostic steps of histamine intolerance online. They were randomly assigned to use one search engine: Google, their personal choice, or Medisuch. Their process of seeking information online was video recorded.
RESULTS


In total, 140 medical students participated in this study. The total number of webpages found did not differ among the groups (P=.52). Students using Medisuch (P=.02) correctly identified the elimination diet as a relevant diagnostic step more frequently. The provocation test was reported by almost half of the students independent of the search engine used. In general, medical students commonly identified trustworthy webpages in all three groups (Google: 36/44, 82%; free choice: 31/36; 86%; and Medisuch: 35/45, 78%).
CONCLUSIONS


The results indicate that medical students were able to find trustworthy health-related information online independent of the search engine used. Medical students that are digital natives seem to have proper internet skills and a knowledge of how to use them. They entered specific medical terms (evidence-based diagnostic steps) or names of reliable webpages (DocCheck) in the search engines to gain correct information. However, it remains to be seen if this behavior can be called true ""digital literacy"".",2020,The results indicate that medical students were able to find trustworthy health-related information online independent of the search engine used.,"['Medical students in their third year of study', '140 medical students participated in this study', ""Undergraduate Medical Students' Search for Health Information Online""]",['histamine intolerance online'],['total number of webpages'],"[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C2363929', 'cui_str': 'Histamine intolerance'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",140.0,0.0204814,The results indicate that medical students were able to find trustworthy health-related information online independent of the search engine used.,"[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Loda', 'Affiliation': 'Medical Department VI/Psychosomatic Medicine and Psychotherapy, University Hospital Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Erschens', 'Affiliation': 'Medical Department VI/Psychosomatic Medicine and Psychotherapy, University Hospital Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Junne', 'Affiliation': 'Medical Department VI/Psychosomatic Medicine and Psychotherapy, University Hospital Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Stengel', 'Affiliation': 'Medical Department VI/Psychosomatic Medicine and Psychotherapy, University Hospital Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Zipfel', 'Affiliation': 'Medical Department VI/Psychosomatic Medicine and Psychotherapy, University Hospital Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Herrmann-Werner', 'Affiliation': 'Medical Department VI/Psychosomatic Medicine and Psychotherapy, University Hospital Tuebingen, Tuebingen, Germany.'}]",JMIR medical informatics,['10.2196/16279']
379,30525935,Quality of Life in Heterogeneous Anxiety Disorders: Changes Across Cognitive-Behavioral Treatments.,"Quality of life is lower among individuals with anxiety disorders; however, this construct is rarely a focus in treatment research. This study explores changes in quality of life in a randomized, controlled trial of several cognitive-behavioral treatments (CBTs) for anxiety disorders. Adults with heterogeneous anxiety disorders ( N  = 223) were randomly assigned to (a) unified protocol for transdiagnostic treatment of emotional disorders, (c) a single-disorder protocol targeting their principal diagnosis, or (c) a waitlist control condition, and assessed at baseline, posttreatment, and 6-month follow-up. At baseline, the sample evidenced deficits in quality of life, with no significant differences in quality of life across diagnoses or condition. Results suggest improved quality of life among participants in treatment, at similar rates across treatment condition and diagnostic category, and at levels significantly higher than the waitlist. Improvements were maintained through 6-month follow-up. This study supports CBT as effective in promoting quality of life.",2020,"At baseline, the sample evidenced deficits in quality of life, with no significant differences in quality of life across diagnoses or condition.","['individuals with anxiety disorders', 'Adults with heterogeneous anxiety disorders ( N = 223', 'anxiety disorders', 'Heterogeneous Anxiety Disorders']","['unified protocol for transdiagnostic treatment of emotional disorders, (c) a single-disorder protocol targeting their principal diagnosis, or (c) a waitlist control condition', 'several cognitive-behavioral treatments (CBTs', 'CBT']","['Quality of Life', 'quality of life', 'quality of life across diagnoses or condition', 'Quality of life']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0233459', 'cui_str': 'Emotional disorder'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0034380'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",223.0,0.0310734,"At baseline, the sample evidenced deficits in quality of life, with no significant differences in quality of life across diagnoses or condition.","[{'ForeName': 'Julianne G', 'Initials': 'JG', 'LastName': 'Wilner', 'Affiliation': 'Boston University, MA, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Dufour', 'Affiliation': 'Massachusetts General Hospital, Boston, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Kennedy', 'Affiliation': 'Fordham University, New York, NY, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Sauer-Zavala', 'Affiliation': 'Boston University, MA, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Boettcher', 'Affiliation': 'Lexington VA Medical Center, KY, USA.'}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Farchione', 'Affiliation': 'Boston University, MA, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Barlow', 'Affiliation': 'Boston University, MA, USA.'}]",Behavior modification,['10.1177/0145445518815603']
380,32404343,Adalimumab dose tapering in patients with rheumatoid arthritis who are in long-standing clinical remission: results of the phase IV PREDICTRA study.,"OBJECTIVE


To investigate the association between baseline disease activity and the occurrence of flares after adalimumab tapering or withdrawal in patients with rheumatoid arthritis (RA) in sustained remission.
METHODS


The PREDICTRA phase IV, randomised, double-blind (DB) study (Im P act of  R esidual Inflammation Detected via Imaging T E chniques,  D rug Levels, and Patient Characteristics on the Outcome of Dose Taper I ng of Adalimumab in  C linical Remission Rheumatoid Ar T hritis ( RA ) Patients) enrolled patients with RA receiving adalimumab 40 mg every other week who were in sustained remission ≥6 months. After a 4-week, open-label lead-in (OL-LI) period, patients were randomised 5:1 to DB adalimumab taper (every 3 weeks) or withdrawal (placebo) for 36 weeks. The primary endpoint was the association between DB baseline hand and wrist MRI-detected inflammation with flare occurrence.
RESULTS


Of 146 patients treated during the OL-LI period, 122 were randomised to taper (n=102) or withdrawal (n=20) arms. Patients had a mean 12.9 years of active disease and had received adalimumab for a mean of 5.4 years (mean 2.2 years in sustained remission). Overall, 37 (36%) and 9 (45%) patients experienced a flare in the taper and withdrawal arms, respectively (time to flare, 18.0 and 13.3 weeks). None of the DB baseline disease characteristics or adalimumab concentration was associated with flare occurrence after adalimumab tapering. Approximately half of the patients who flared regained clinical remission after 16 weeks of open-label rescue adalimumab. The safety profile was consistent with previous studies.
CONCLUSIONS


Approximately one-third of patients who tapered adalimumab versus half who withdrew adalimumab experienced a flare within 36 weeks. Time to flare was numerically longer in the taper versus withdrawal arm. Baseline MRI inflammation was not associated with flare occurrence.
TRIAL REGISTRATION NUMBER


NCT02198651, EudraCT 2014-001114-26.",2020,None of the DB baseline disease characteristics or adalimumab concentration was associated with flare occurrence after adalimumab tapering.,"['patients with rheumatoid arthritis (RA) in sustained remission', 'Patients had a mean 12.9 years of active disease and had received adalimumab for a mean of 5.4 years (mean 2.2 years in sustained remission', 'C linical Remission Rheumatoid Ar T hritis ( RA ) Patients) enrolled patients with RA receiving adalimumab 40\u2009mg every other week who were in sustained remission ≥6 months', '146 patients treated during the OL-LI period, 122 were randomised to taper (n=102) or withdrawal (n=20) arms', 'patients with rheumatoid arthritis who are in long-standing clinical remission']","['DB adalimumab taper (every 3 weeks) or withdrawal (placebo', 'adalimumab tapering or withdrawal', 'Adalimumab', 'tapered adalimumab']","['association between DB baseline hand and wrist MRI-detected inflammation with flare occurrence', 'Baseline MRI inflammation', 'DB baseline disease characteristics or adalimumab concentration', 'clinical remission', 'Time to flare']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0412709', 'cui_str': 'MRI of wrist'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.196623,None of the DB baseline disease characteristics or adalimumab concentration was associated with flare occurrence after adalimumab tapering.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK p.emery@leeds.ac.uk.'}, {'ForeName': 'Gerd R', 'Initials': 'GR', 'LastName': 'Burmester', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Naredo', 'Affiliation': 'Department of Rheumatology, Joint and Bone Research Unit, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Sinigaglia', 'Affiliation': 'Department of Rheumatology and Medical Sciences, Centro Specialistico Ortopedico Traumatologico Pini-CTO, Milan, Italy.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Lagunes', 'Affiliation': 'Global Medical Affairs Rheumatology, AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Koenigsbauer', 'Affiliation': 'Data and Statistical Sciences, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.'}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Conaghan', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217246']
381,32055002,Survival outcomes and risk group validation from SWOG S0925: a randomized phase II study of cixutumumab in new metastatic hormone-sensitive prostate cancer.,"BACKGROUND


Cixutumumab, a monoclonal antibody targeting insulin-like growth factor I receptor, did not improve undetectable prostate-specific antigen (PSA) rate at 28 weeks when combined with androgen deprivation in the randomized phase II SWOG S0925 trial for patients with new metastatic hormone-sensitive prostate cancer. We now present mature survival analyses, along with pre-specified secondary and exploratory endpoints.
METHODS


We randomized 210 patients to androgen deprivation with or without cixutumumab, 105 per treatment arm. We used Kaplan-Meier curves to analyze overall survival, radiographic progression-free survival, and castration resistance-free survival by treatment arm, disease volume, and risk group. We explored differences in survival by treatment arm via covariate-adjusted Cox proportional hazards models adjusted for disease volume and risk.
RESULTS


No difference was seen between treatment arms in overall survival (HR 1.01 [0.70-1.45]; p = 0.97), radiographic progression-free survival (HR 1.17 [0.85-1.60]; p = 0.35), or castration resistance-free survival (HR 1.02 [0.75-1.41]; p = 0.88). At baseline, 105/198 (53.0%) patients had high-risk features and 119/210 (56.7%) had high-volume disease; 16.7% of patients had discordant classifications of high or low category for risk and volume. Adjusting for risk or volume yielded no differences in overall survival between arms. Inferior survival was observed in high-risk (HR 1.89 [1.29-2.80]; p = 0.001) and high-volume (HR 2.75 [1.84-4.10]; p < 0.0001) disease. Disease volume was a better fit to survival data than risk group (AIC 878.3 vs. 889.2). Compared to patients achieving undetectable PSA at 28 weeks, inferior survival was observed in patients whose PSA was >0.2 to ≤4.0 ng/mL (HR 3.72 [1.99-6.95]; p < 0.0001) or >4.0 ng/mL (HR 7.13 [4.24-11.9]; p < 0.0001).
CONCLUSIONS


In new metastatic hormone-sensitive prostate cancer, addition of cixutumumab to androgen deprivation did not improve survival. Baseline risk and disease volume carried prognostic value for this distinct trial population, although disease volume added more prognostic information. PSA treatment response was a strong intermediate endpoint for survival.",2020,"No difference was seen between treatment arms in overall survival (HR 1.01 [0.70-1.45]; p = 0.97), radiographic progression-free survival (HR 1.17 [0.85-1.60]; p = 0.35), or castration resistance-free survival (HR 1.02 [0.75-1.41]; p = 0.88).","['patients with new metastatic hormone-sensitive prostate cancer', '210 patients to androgen deprivation with or without cixutumumab, 105 per treatment arm', 'new metastatic hormone-sensitive prostate cancer']",['cixutumumab'],"['Inferior survival', 'radiographic progression-free survival', 'inferior survival', 'Survival outcomes', 'overall survival, radiographic progression-free survival, and castration resistance-free survival', 'castration resistance-free survival', 'survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C2699335'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]",[{'cui': 'C2699335'}],"[{'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0007344', 'cui_str': 'Gonadectomy'}]",210.0,0.28146,"No difference was seen between treatment arms in overall survival (HR 1.01 [0.70-1.45]; p = 0.97), radiographic progression-free survival (HR 1.17 [0.85-1.60]; p = 0.35), or castration resistance-free survival (HR 1.02 [0.75-1.41]; p = 0.88).","[{'ForeName': 'Risa L', 'Initials': 'RL', 'LastName': 'Wong', 'Affiliation': 'Division of Oncology, Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Mai T', 'Initials': 'MT', 'LastName': 'Duong', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Tangen', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Heather H', 'Initials': 'HH', 'LastName': 'Cheng', 'Affiliation': 'Division of Oncology, Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Vogelzang', 'Affiliation': 'US Oncology, Las Vegas, NV, USA.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': 'CHRISTUS Santa Rosa Medical Center Hospital, San Antonio, TX, USA.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Quinn', 'Affiliation': 'Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Evan Y', 'Initials': 'EY', 'LastName': 'Yu', 'Affiliation': 'Division of Oncology, Department of Medicine, University of Washington, Seattle, WA, USA. evanyu@uw.edu.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-020-0210-x']
382,29856832,Using financial incentives to promote physical activity in American Indian adolescents: A randomized controlled trial.,"American Indians (AI) have high prevalence of diabetes in youth and may benefit from increasing physical activity as a strategy to improve metabolic health. We tested whether financial incentives would elicit greater frequency and/or duration of exercise in AI youth at high risk for developing diabetes. Overweight/obese AI boys and girls, 11-20 years old, were instructed to exercise on 3 days/week for 48 weeks at a tribal wellness center. The program was divided into three, 16-week-long phases to test different financial incentive strategies. Within each phase participants were randomly assigned to one of two groups that received different payments for exercise. Phase 1 was designed to test whether the size of the incentive would affect exercise frequency. In Phase 1, the number of exercise sessions did not differ between the group receiving a modest fixed-value payment per exercise session and the group receiving enhanced incentives to exercise more frequently (26 ± 3 versus 28 ± 2 sessions, respectively, p = 0.568). In Phase 2, the provision of an enhanced financial incentive to increase exercise duration resulted longer sessions, as the incentivized and standard payment groups exercised 38 ± 2 versus 29 ± 1 minutes per session (p = 0.002), respectively. In Phase 3, the effect of reducing the incentives on maintenance of exercise behaviors was inconclusive due to high participant withdrawal. Aerobic fitness increased 10% during Phase 1 but was unchanged thereafter. Insulin sensitivity and body composition were unchanged during the study. In conclusion, enhanced financial incentives increased the duration of exercise sessions, but had minimal effects on exercise participation. These results indicate that financial incentives hold promise in motivating previously sedentary, overweight/obese adolescents to exercise longer, but motivating them to sustain an exercise program remains the major challenge.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01848353.",2018,Insulin sensitivity and body composition were unchanged during the study.,"['AI youth at high risk for developing diabetes', 'American Indian adolescents', 'Overweight/obese AI boys and girls, 11-20 years old']",[],"['Aerobic fitness', 'Insulin sensitivity and body composition', 'number of exercise sessions']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0002460', 'cui_str': 'American Indians'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]",[],"[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0336781,Insulin sensitivity and body composition were unchanged during the study.,"[{'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Short', 'Affiliation': 'Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States of America.'}, {'ForeName': 'Jennifer Q', 'Initials': 'JQ', 'LastName': 'Chadwick', 'Affiliation': 'Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States of America.'}, {'ForeName': 'Tamela K', 'Initials': 'TK', 'LastName': 'Cannady', 'Affiliation': 'Choctaw Nation of Oklahoma, Durant, OK, United States of America.'}, {'ForeName': 'Dannielle E', 'Initials': 'DE', 'LastName': 'Branam', 'Affiliation': 'Choctaw Nation of Oklahoma, Durant, OK, United States of America.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Wharton', 'Affiliation': 'Choctaw Nation of Oklahoma, Durant, OK, United States of America.'}, {'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Tullier', 'Affiliation': 'Choctaw Nation of Oklahoma, Durant, OK, United States of America.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Thompson', 'Affiliation': 'Department of Biostatistics and Epidemiology, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States of America.'}, {'ForeName': 'Kenneth C', 'Initials': 'KC', 'LastName': 'Copeland', 'Affiliation': 'Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States of America.'}]",PloS one,['10.1371/journal.pone.0198390']
383,30053298,Correction of metabolic acidosis improves muscle mass and renal function in chronic kidney disease stages 3 and 4: a randomized controlled trial.,"BACKGROUND


Metabolic acidosis (MA) is associated with a loss of muscle mass and faster deterioration of kidney function in patients with chronic kidney disease (CKD). A few single-centre randomized trials have reported favourable outcomes following correction of MA. Additional good quality evidence on the safety and efficacy of alkali supplementation is required in epidemiologically different patient subsets with CKD.
METHODS


A single-centre, open-label, randomized, prospective parallel-group study was conducted to assess the effect of correction of MA on body composition and kidney function. A total of 188 patients with CKD stages 3 and 4, with venous bicarbonate levels <22 mEq/L were randomized. The intervention arm received standard care as per Kidney Disease: Improving Global Outcomes (KDIGO) 2012 guidelines along with oral sodium bicarbonate supplementation to maintain venous bicarbonate levels at 24-26 mEq/L, whereas the control group received standard care alone. The mid-arm muscle circumference (MAMC), lean body mass (LBM) and estimated glomerular filtration rate (eGFR) were compared between the groups at the end of 6 months.
RESULTS


The intervention arm showed a higher LBM {36.8 kg [95% confidence interval (CI) 36.5-37.1] versus 36 [35.7-36.4]; P = 0.002} and MAMC [22.9 cm (95% CI 22.8-23) versus 22.6 (22.5-22.7); P = 0.001] when compared with the control group. The GFR in the intervention arm was higher [32.74 mL/1.73 m2 (95% CI 31.5-33.9) versus 28.2 (27-29.4); P ≤ 0.001]. A rapid decline in GFR was documented in 39 (41.5%) patients in the control arm and 19 (20.2%) patients in the intervention arm (P = 0.001).
CONCLUSIONS


Alkali supplementation to increase venous bicarbonate levels to 24-26 mEq/L is associated with preservation of LBM and kidney function in patients with CKD stages 3 and 4.",2020,"The mid-arm muscle circumference (MAMC), lean body mass (LBM) and estimated glomerular filtration rate (eGFR) were compared between the groups at the end of 6 months.
","['epidemiologically different patient subsets with CKD', 'chronic kidney disease stages 3 and 4', 'patients with CKD stages 3 and 4', '188 patients with CKD stages 3 and 4, with venous bicarbonate levels\u2009<22 mEq/L were randomized', 'patients with chronic kidney disease (CKD']","['metabolic acidosis', 'control group received standard care alone', 'MA', 'alkali supplementation', 'standard care as per Kidney Disease: Improving Global Outcomes (KDIGO) 2012 guidelines along with oral sodium bicarbonate supplementation']","['GFR', 'body composition and kidney function', 'mid-arm muscle circumference (MAMC), lean body mass (LBM) and estimated glomerular filtration rate (eGFR', 'venous bicarbonate levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2316787', 'cui_str': 'CKD stage 3'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0428196', 'cui_str': 'Bicarbonate level - finding'}, {'cui': 'C0439375', 'cui_str': 'mEq/L'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0220981', 'cui_str': 'Metabolic acidosis (disorder)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002055', 'cui_str': 'Alkalies'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0562347', 'cui_str': 'Mid arm muscle circumference (observable entity)'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C3811844'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0428196', 'cui_str': 'Bicarbonate level - finding'}]",188.0,0.122792,"The mid-arm muscle circumference (MAMC), lean body mass (LBM) and estimated glomerular filtration rate (eGFR) were compared between the groups at the end of 6 months.
","[{'ForeName': 'Avinash Kumar', 'Initials': 'AK', 'LastName': 'Dubey', 'Affiliation': 'Departments of Nephrology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}, {'ForeName': 'Jayaprakash', 'Initials': 'J', 'LastName': 'Sahoo', 'Affiliation': 'Endocrinology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}, {'ForeName': 'Balasubramanian', 'Initials': 'B', 'LastName': 'Vairappan', 'Affiliation': 'Biochemistry, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Haridasan', 'Affiliation': 'Departments of Nephrology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}, {'ForeName': 'Sreejith', 'Initials': 'S', 'LastName': 'Parameswaran', 'Affiliation': 'Departments of Nephrology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Priyamvada', 'Affiliation': 'Departments of Nephrology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfy214']
384,31733345,Principal results of the VITamin D and OmegA-3 TriaL (VITAL) and updated meta-analyses of relevant vitamin D trials.,"Whether supplemental vitamin D reduces risk of cancer or cardiovascular disease (CVD) is relatively unexplored in randomized trial settings. The VITamin D and OmegA-3 TriaL (VITAL) was a nationwide, randomized, placebo-controlled, 2 × 2 factorial trial of daily vitamin D 3  (2000 IU) and marine omega-3 fatty acids (1 g) in the primary prevention of cancer and CVD among 25,871 U.S. men aged ≥50 and women aged ≥55, including 5106 African Americans. Median treatment duration was 5.3 years. Vitamin D did not significantly reduce the primary endpoint of total invasive cancer incidence (hazard ratio [HR] = 0.96 [95% confidence interval 0.88-1.06]) but showed a promising signal for reduction in total cancer mortality (HR = 0.83 [0.67-1.02]), especially in analyses that accounted for latency by excluding the first year (HR = 0.79 [0.63-0.99]) or first 2 years (HR = 0.75 [0.59-0.96]) of follow-up. Vitamin D did not significantly reduce the co-primary endpoint of major CVD events (HR = 0.97 [0.85-1.12]), other cardiovascular endpoints, or all-cause mortality (HR = 0.99 [0.87-1.12]). Updated meta-analyses that include VITAL and other recent vitamin D trials indicate a significant reduction in cancer mortality but not in cancer incidence or CVD endpoints. Additional research is needed to determine which individuals may be most likely to derive a net benefit from vitamin D supplementation. (VITAL clinicaltrials.gov identifier: NCT01169259).",2020,"Vitamin D did not significantly reduce the co-primary endpoint of major CVD events (HR = 0.97 [0.85-1.12]), other cardiovascular endpoints, or all-cause mortality (HR = 0.99 [0.87-1.12]).","['25,871 U.S. men aged ≥50 and women aged ≥55, including 5,106 African Americans']","['placebo', 'daily vitamin D 3  (2000 IU) and marine omega-3 fatty acids', 'supplemental vitamin D', 'VITamin D and OmegA-3 TriaL', 'Vitamin D']","['total cancer mortality', 'total invasive cancer incidence', 'risk of cancer or cardiovascular disease (CVD', 'co-primary endpoint of major CVD events', 'cancer mortality']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.639178,"Vitamin D did not significantly reduce the co-primary endpoint of major CVD events (HR = 0.97 [0.85-1.12]), other cardiovascular endpoints, or all-cause mortality (HR = 0.99 [0.87-1.12]).","[{'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, United States. Electronic address: jmanson@rics.bwh.harvard.edu.""}, {'ForeName': 'Shari S', 'Initials': 'SS', 'LastName': 'Bassuk', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, United States.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of steroid biochemistry and molecular biology,['10.1016/j.jsbmb.2019.105522']
385,32404389,Focus group discussions on low-flow oxygen and bubble CPAP treatments among mothers of young children in Malawi: a CPAP IMPACT substudy.,"OBJECTIVE


To determine the acceptability of bubble continuous positive airway pressure (bCPAP) and low-flow oxygen among mothers of children who had received either therapy.
SETTING


A district hospital in Salima, Malawi.
PARTICIPANTS


We conducted eight focus group discussions (FGDs) with a total of 54 participants. Eligible participants were mothers of children 1 to 59 months of age with severe pneumonia and a comorbidity (HIV-infection, HIV-exposure, malnutrition or hypoxaemia) who, with informed consent, had been enrolled in a randomised clinical trial, CPAP IMPACT (Improving Mortality for Pneumonia in African Children Trial), comparing low-flow oxygen and bCPAP treatments (ClinicalTrials.gov, NCT02484183).
PRIMARY AND SECONDARY OUTCOME MEASURES


FGDs assessed mothers' attitudes and feelings towards oxygen and bCPAP before and after therapy along with general community perceptions of respiratory therapies. Data was analysed using inductive thematic analysis to assess themes and subthemes of the transcripts.
RESULTS


Community perceptions of oxygen and bCPAP were widely negative. Mothers recounted that they are told that 'oxygen kills babies'. They are often fearful of allowing their child to receive oxygen therapy and will delay treatment or seek alternative therapies. Mothers report limiting oxygen and bCPAP by intermittently removing the nasal cannulas or mask. After oxygen or bCPAP treatment, regardless of patient outcome, mothers were supportive of the treatment their child received and would recommend it to other mothers.
CONCLUSION


There are significant community misconceptions around oxygen and bCPAP causing mothers to be fearful of either treatment. In order for low-flow oxygen treatment and bCPAP implementation to be effective, widespread community education is necessary.",2020,"After oxygen or bCPAP treatment, regardless of patient outcome, mothers were supportive of the treatment their child received and would recommend it to other mothers.
","['mothers of children who had received either therapy', 'We conducted eight focus group discussions (FGDs) with a total of 54 participants', 'A district hospital in Salima, Malawi', 'Eligible participants were mothers of children 1 to 59 months of age with severe pneumonia and a comorbidity (HIV-infection, HIV-exposure, malnutrition or hypoxaemia) who, with informed consent', 'mothers of young children in Malawi']","['bubble continuous positive airway pressure (bCPAP) and low-flow oxygen', 'bCPAP', 'CPAP IMPACT', 'low-flow oxygen and bubble CPAP treatments']","[""FGDs assessed mothers' attitudes and feelings towards oxygen and bCPAP""]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205454', 'cui_str': '8'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020006', 'cui_str': 'District hospital'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]","[{'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}]",54.0,0.106875,"After oxygen or bCPAP treatment, regardless of patient outcome, mothers were supportive of the treatment their child received and would recommend it to other mothers.
","[{'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Sessions', 'Affiliation': 'Pediatrics, McGaw Medical Center of Northwestern University, Chicago, Illinois, United States ksessions@luriechildrens.org.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ruegsegger', 'Affiliation': 'Project Malawi, University of North Carolina System, Lilongwe, Malawi.'}, {'ForeName': 'Tisungane', 'Initials': 'T', 'LastName': 'Mvalo', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Davie', 'Initials': 'D', 'LastName': 'Kondowe', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Mercy', 'Initials': 'M', 'LastName': 'Tsidya', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Lufesi', 'Affiliation': 'Acute Respiratory Infection Unit, Ministry of Health, Lilongwe, Malawi.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Eckerle', 'Affiliation': ""Emergency Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States.""}, {'ForeName': 'Andrew Gerald', 'Initials': 'AG', 'LastName': 'Smith', 'Affiliation': 'Pediatric Critical Care Medicine, University of Utah, Salt Lake City, Utah, United States.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'McCollum', 'Affiliation': 'Eudowood Division of Pediatric Respiratory Sciences, Johns Hopkins School of Medicine, Baltimore, Maryland, United States.'}]",BMJ open,['10.1136/bmjopen-2019-034545']
386,32404390,Effects of an automated digital brief prevention intervention targeting adolescents and young adults with risky alcohol and other substance use: study protocol for a randomised controlled trial.,"INTRODUCTION


Adolescence and young adulthood is a period in life when individuals may be especially vulnerable to harmful substance use. Several critical developmental processes are occurring in the brain, and substance use poses both short-term and long-term risks with regard to mental health and social development. From a public health perspective, it is important to prevent or delay substance use to reduce individual risk and societal costs. Given the scarcity of effective interventions targeting substance use among adolescents and young adults, cost-effective and easily disseminated interventions are warranted. The current study will test the effectiveness of a fully automated digital brief intervention aimed at reducing alcohol and other substance use in adolescents and young adults aged 15 to 25 years.
METHODS AND ANALYSIS


A two-arm, double-blind, randomised controlled trial design is applied to assess the effectiveness of the intervention. Baseline assessment, as well as 3-month and 6-month follow-up, will be carried out. The aim is to include 800 participants with risky substance use based on the screening tool CRAFFT (Car,Relax, Alone, Forget, Friends, Trouble). Recruitment, informed consent, randomisation, intervention and follow-up will be implemented online. The primary outcome is reduction in alcohol use, measured by Alcohol Use Disorders Identification Test total score. Secondary outcomes concern binge drinking, frequency of alcohol consumption, amount of alcohol consumed a typical day when alcohol is consumed, average daily drinks per typical week, other substance use, mental health, sexual risk behaviours and perceived peer pressure. Moreover, the study involves analyses of potential moderators including perfectionism, openness to parents, help-seeking and background variables.
ETHICS AND DISSEMINATION


The study was approved by the Swedish Ethical Review Authority (no. 2019-03249). The trial is expected to expand the knowledge on digital preventive interventions for substance using adolescents and young adults. Results will be disseminated in research journals, at conferences and via the media.
TRIAL REGISTRATION NUMBER


24 September 2019, ISRCTN91048246; Pre-results.",2020,"The current study will test the effectiveness of a fully automated digital brief intervention aimed at reducing alcohol and other substance use in adolescents and young adults aged 15 to 25 years.
","['adolescents and young adults aged 15 to 25 years', 'substance using adolescents and young adults', 'adolescents and young adults', 'adolescents and young adults with risky alcohol and other substance use', '800 participants with risky substance use based on the screening tool CRAFFT (Car,Relax, Alone, Forget, Friends, Trouble']",['automated digital brief prevention intervention'],"['binge drinking, frequency of alcohol consumption, amount of alcohol consumed a typical day when alcohol is consumed, average daily drinks per typical week, other substance use, mental health, sexual risk behaviours and perceived peer pressure', 'reduction in alcohol use, measured by Alcohol Use Disorders Identification Test total score']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0079382', 'cui_str': 'Friend'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0562366', 'cui_str': 'Pressured by peers'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",800.0,0.0827623,"The current study will test the effectiveness of a fully automated digital brief intervention aimed at reducing alcohol and other substance use in adolescents and young adults aged 15 to 25 years.
","[{'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Kvillemo', 'Affiliation': 'STAD (Stockholm Prevents Alcohol and Drug Problems), Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden pia.kvillemo@ki.se.'}, {'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Strandberg', 'Affiliation': 'STAD (Stockholm Prevents Alcohol and Drug Problems), Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Gripenberg', 'Affiliation': 'STAD (Stockholm Prevents Alcohol and Drug Problems), Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Berman', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Skoglund', 'Affiliation': 'STAD (Stockholm Prevents Alcohol and Drug Problems), Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Tobias H', 'Initials': 'TH', 'LastName': 'Elgán', 'Affiliation': 'STAD (Stockholm Prevents Alcohol and Drug Problems), Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}]",BMJ open,['10.1136/bmjopen-2019-034894']
387,32404342,"Canakinumab for Treatment of Adult-Onset Still's Disease to Achieve Reduction of Arthritic Manifestation (CONSIDER): phase II, randomised, double-blind, placebo-controlled, multicentre, investigator-initiated trial.","BACKGROUND


Inhibition of interleukin (IL)-1 represents a promising treatment option in adult-onset Still's disease (AOSD).
OBJECTIVE


To investigate the efficacy and safety of canakinumab in patients with AOSD and active joint involvement by means of a multicentre, double-blind, randomised, placebo-controlled trial.
METHODS


Patients with AOSD and active joint involvement (tender and swollen joint counts of ≥4 each) were treated with canakinumab (4 mg/kg, maximum 300 mg subcutaneous every 4 weeks) or placebo. The primary endpoint was the proportion of patients with a clinically relevant reduction in disease activity at week 12 as determined by the change in disease activity score (ΔDAS28>1.2).
RESULTS


At enrolment, patients had high active disease with a mean DAS28(ESR) of 5.4 in the canakinumab and 5.3 in the placebo group, respectively. In the intention-to-treat analysis, 12 patients (67%) in the canakinumab group and 7 patients (41%) in the placebo group fulfilled the primary outcome criterion (p=0.18). In the per-protocol analysis, significantly higher American College of Rheumatology (ACR) 30% (61% vs 20%, p=0.033), ACR 50% (50% vs 6.7%, p=0.009) and ACR 70% (28% vs 0%, p=0.049) response rates were observed in the canakinumab group compared with the placebo group. Two patients in the canakinumab group experienced a serious adverse event.
CONCLUSION


Although the study was terminated prematurely and the primary endpoint was not achieved, treatment with canakinumab led to an improvement of several outcome measures in AOSD. The overall safety findings were consistent with the known profile of canakinumab. Thus, our data support indication for IL-1 inhibition with canakinumab in AOSD.",2020,"Two patients in the canakinumab group experienced a serious adverse event.
","[""adult-onset Still's disease (AOSD"", 'patients had high active disease with a mean DAS28(ESR) of 5.4 in the canakinumab and 5.3 in the', 'patients with AOSD and active joint involvement by means of a multicentre', 'Adult-Onset', 'Patients with AOSD and active joint involvement (tender and swollen joint counts of ≥4\u2009each']","['canakinumab', 'interleukin (IL)-1', 'Canakinumab', 'canakinumab (4\u2009mg/kg, maximum 300\u2009mg subcutaneous every 4 weeks) or placebo', 'placebo']","['several outcome measures in AOSD', 'response rates', 'American College of Rheumatology (ACR', 'disease activity score (ΔDAS28>1.2', 'serious adverse event', 'proportion of patients with a clinically relevant reduction in disease activity', 'efficacy and safety']","[{'cui': 'C0085253', 'cui_str': ""Adult onset Still's disease""}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0234234', 'cui_str': 'Tender'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count'}]","[{'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0085253', 'cui_str': ""Adult onset Still's disease""}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.675758,"Two patients in the canakinumab group experienced a serious adverse event.
","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Kedor', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany claudia.kedor@charite.de.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Listing', 'Affiliation': 'Epidemiology Unit, German Rheumatism Research Centre, Berlin, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Zernicke', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Weiß', 'Affiliation': 'Epidemiology Unit, German Rheumatism Research Centre, Berlin, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Behrens', 'Affiliation': 'CIRI/Rheumatology and Fraunhofer TMP, Goethe-University, Frankfurt, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Blank', 'Affiliation': 'Internal Medicine 5, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Joerg Christoph', 'Initials': 'JC', 'LastName': 'Henes', 'Affiliation': 'Centre for Interdisciplinary Clinical Immunology, Rheumatology and Auto-inflammatory Diseases and Department of Internal Medicine II (Oncology, Haematology, Immunology, Rheumatology, Pulmology), University Hospital Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Joern', 'Initials': 'J', 'LastName': 'Kekow', 'Affiliation': 'Clinic of Rheumatology and Orthopaedics, Otto-von-Guericke University Magdeburg, Vogelsang-Gommern, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rubbert-Roth', 'Affiliation': 'Division of Rheumatology, Cantonal Hospital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Schulze-Koops', 'Affiliation': 'Department of Rheumatology, University of Munich, Munich, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Seipelt', 'Affiliation': 'Abteilung Rheumatologie und Klinische Immunologie, Immanuel Krankenhaus Berlin, Standort Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Specker', 'Affiliation': 'Klinik für Rheumatologie und Klinische Immunologie, KEM Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Feist', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217155']
388,31295363,"Higher dietary protein intake preserves lean body mass, lowers liver lipid deposition, and maintains metabolic control in participants with long-chain fatty acid oxidation disorders.","Medical nutrition therapy for long-chain fatty acid oxidation disorders (LC-FAODs) currently emphasizes fasting avoidance, restricted dietary long-chain fatty acid intake, supplementation with medium chain triglycerides, and increased carbohydrate intake. We hypothesize that increasing dietary protein intake relative to carbohydrate intake would preserve metabolic control yet induce physical benefits including reduced hepatic lipogenesis. Therefore, we compared two dietary approaches with similar fat intake but different carbohydrate to protein ratios in participants diagnosed with LC-FAODs. Thirteen participants were enrolled and randomized into either a high-protein (PRO) or a high-carbohydrate (CHO) diet for 4 months. Baseline and 4-month assessments included body composition, ectopic lipid deposition, and resting energy expenditure. End of study assessments also included total energy expenditure, metabolic responses to oral feedings, and whole-body fatty acid oxidation capacity. At the end of the dietary intervention, both groups had similar energy expenditure, fat and glucose oxidation rates, and glucolipid responses to mixed meal and oral glucose loads. Neither dietary group experienced worsening symptoms related to their LC-FAOD. Compared to the CHO group, the PRO group exhibited increased blood levels of short-chain acylcarnitines, reduced intrahepatic lipid content, and maintained lean body mass while the CHO group lost lean mass. In patients with LC-FAODs, increasing protein intake maintained metabolic control, reduced liver fat without risk of metabolic decompensation, and helped preserve lean body mass. We propose that a modest increase in dietary protein along with fasting avoidance and fat restriction may improve body composition and energy expenditure in patients with LC-FAODs.",2019,"In patients with LC-FAODs, increasing protein intake maintained metabolic control, reduced liver fat without risk of metabolic decompensation, and helped preserve lean body mass.","['participants with long-chain fatty acid oxidation disorders', 'Thirteen participants', 'participants diagnosed with LC-FAODs', 'patients with LC-FAODs']","['high-protein (PRO) or a high-carbohydrate (CHO) diet', 'CHO', 'Medical nutrition therapy']","['total energy expenditure, metabolic responses to oral feedings, and whole-body fatty acid oxidation capacity', 'blood levels of short-chain acylcarnitines, reduced intrahepatic lipid content, and maintained lean body mass', 'body composition and energy expenditure', 'lean body mass, lowers liver lipid deposition', 'energy expenditure, fat and glucose oxidation rates, and glucolipid responses to mixed meal and oral glucose loads', 'worsening symptoms', 'body composition, ectopic lipid deposition, and resting energy expenditure']","[{'cui': 'C0522095', 'cui_str': 'Long chain fatty acid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0259835', 'cui_str': 'High carbohydrate diet (finding)'}, {'cui': 'C1257928', 'cui_str': 'Medical Nutrition Therapy'}]","[{'cui': 'C0429629', 'cui_str': 'Total energy expenditure (observable entity)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0368608', 'cui_str': 'acylcarnitine'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0333574', 'cui_str': 'Fatty deposition'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0340464', 'cui_str': 'Premature Cardiac Complex'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",13.0,0.0245497,"In patients with LC-FAODs, increasing protein intake maintained metabolic control, reduced liver fat without risk of metabolic decompensation, and helped preserve lean body mass.","[{'ForeName': 'Melanie B', 'Initials': 'MB', 'LastName': 'Gillingham', 'Affiliation': 'Department of Molecular and Medical Genetics, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Elizondo', 'Affiliation': 'Department of Molecular and Medical Genetics, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Behrend', 'Affiliation': 'Department of Molecular and Medical Genetics, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Dietrich', 'Initials': 'D', 'LastName': 'Matern', 'Affiliation': 'Biochemical Genetics Laboratory, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Dale A', 'Initials': 'DA', 'LastName': 'Schoeller', 'Affiliation': 'Department of Nutritional Sciences, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Cary O', 'Initials': 'CO', 'LastName': 'Harding', 'Affiliation': 'Department of Molecular and Medical Genetics, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Jonathan Q', 'Initials': 'JQ', 'LastName': 'Purnell', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health and Science University, Portland, Oregon.'}]",Journal of inherited metabolic disease,['10.1002/jimd.12155']
389,32200610,Comparison of two methods of continuous femoral nerve block with elastomeric pump after total knee arthroplasty.,"BACKGROUND


The best method of continuous femoral nerve block (CFNB) after total knee arthroplasty (TKA) has not been determined. The study aimed to assess the effectiveness of CFNB based on patient-controlled regional analgesia (PCRA) with basal infusion of local anesthetic in decreasing pain and providing functional restoration after TKA and to compare it with the method of basal infusion only.
METHODS


The prospective randomized controlled trial included 90 patients who were divided into three groups. Group I: control group with basal morphine infusion, without CFNB. Group II: CFNB with continuous infusion of ropivacaine. Group III: CFNB with basal infusion of ropivacaine plus boluses. Intensity of pain, morphine consumption, patient satisfaction, adverse effects, the effect on range of motion (ROM) in the knee joint, as well as using the measure of a distance were analyzed.
RESULTS


A lower level of pain was observed (P < 0.005), as was reduced opioid consumption (P < 0.005), a greater ROM (P < 0.005), a longer distance covered (P < 0.005), and a smaller incidence of nausea in group III when compared with group II. No statistically significant difference was noted between the groups in terms of other side effects. There was higher satisfaction between group II and group III on days 1 and 2 (P < 0.08).
CONCLUSIONS


It was demonstrated that CFNB with continuous infusion of 5 mL h-1 of 0.2% ropivacaine plus 5 mL as a bolus causes a greater reduction in pain intensity and opioid consumption; it also shortens the time of functional restoration in comparison to perineural infusion of 5mL h-1 only during the first 4 days after TKA and constitutes an effective and safe alternative to using an electronic pump.",2020,"A lower level of pain was observed (P < 0.005), as was reduced opioid consumption (P < 0.005), a greater ROM (P < 0.005), a longer distance covered (P < 0.005), and a smaller incidence of nausea in group III when compared with group II.","['after total knee arthroplasty', '90 patients who were divided into three groups']","['continuous femoral nerve block (CFNB', 'ropivacaine', 'continuous femoral nerve block with elastomeric pump', 'local anesthetic', 'ropivacaine plus boluses', 'CFNB', 'control group with basal morphine infusion, without CFNB', 'total knee arthroplasty (TKA']","['Intensity of pain, morphine consumption, patient satisfaction, adverse effects, the effect on range of motion (ROM', 'higher satisfaction', 'greater ROM', 'opioid consumption', 'pain intensity and opioid consumption', 'pain and providing functional restoration', 'level of pain', 'nausea']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block (procedure)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0444925', 'cui_str': 'elastomeric'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",90.0,0.0787619,"A lower level of pain was observed (P < 0.005), as was reduced opioid consumption (P < 0.005), a greater ROM (P < 0.005), a longer distance covered (P < 0.005), and a smaller incidence of nausea in group III when compared with group II.","[{'ForeName': 'Bulat', 'Initials': 'B', 'LastName': 'Tuyakov', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Collegium Medicum, University of Warmia and Mazury, Olsztyn, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Mieszkowski', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Collegium Medicum, University of Warmia and Mazury, Olsztyn, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Onichimowski', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Collegium Medicum, University of Warmia and Mazury, Olsztyn, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Mayzner-Zawadzka', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Collegium Medicum, University of Warmia and Mazury, Olsztyn, Poland.'}]",Anaesthesiology intensive therapy,['10.5114/ait.2020.93710']
390,32202124,Efficacy of dry needling as an adjunct to manual therapy for patients with chronic mechanical neck pain: a randomised clinical trial.,"OBJECTIVE


Chronic mechanical neck pain is associated with musculoskeletal tissue alterations. Active trigger points in the trapezius and levator scapulae muscles are common in patients with chronic mechanical neck pain. In this study, we compared the effect of dry needling (DN) combined with manual therapy (MT) to sham dry needling (SDN) combined with MT on pain, pain pressure threshold, cervical range of motion and neck disability in patients with chronic mechanical neck pain.
METHODS


A randomised, single-blind clinical trial was carried out involving 101 participants with chronic mechanical neck pain, divided into an intervention group (DN+MT, n=47) and a control group (SDN+MT, n=54). Participants received two treatment sessions. The intervention group received MT in conjunction with DN of the most mechano-sensitive myofascial trigger point (MTrP). The control group received MT plus SDN. Outcomes measures were: pain intensity (numeric pain rating scale, NPRS), pressure pain threshold (PPT), cervical range of motion (ROM) and neck disability (neck disability index, NDI).
RESULTS


This study found that between-group differences in pain intensity were statistically significant (P<0.01). Pain decreased after the first intervention in the DN+MT group (3.47±0.25 points on the NPRS) and even more so after the second intervention (4.76±0.24 points on the NPRS). After 4 weeks, pain intensity differed from baseline by 4.89±0.27 points on the NPRS. Statistically significant differences (P<0.001) in PPT were also found between the intervention group and the control group. After the first intervention, a significant increase in PPT within the DN+MT group (3.09±0.8 kg/cm 2 ) was observed. Cervical ROM also showed highly statistically significant differences. After 4 weeks, a statistically significant reduction (P<0.001) in NDI was observed between the two groups.
CONCLUSION


Our results show that DN+MT is efficacious and significantly better than SDN+MT at reducing pain intensity, PPT, neck disability and cervical ROM in patients with chronic mechanical neck pain.
LEVEL OF EVIDENCE


1b.",2020,Statistically significant differences (P<0.001) in PPT were also found between the intervention group and the control group.,"['patients with chronic mechanical neck pain', '101 participants with chronic mechanical neck pain, divided into an intervention group (DN+MT, n=47) and a control group (SDN+MT, n=54']","['SDN+MT', 'MT in conjunction with DN of the most mechano-sensitive myofascial trigger point (MTrP', 'dry needling', 'DN+MT', 'manual therapy', 'MT plus SDN', 'dry needling (DN) combined with manual therapy (MT) to sham dry needling (SDN) combined with MT']","['pain, pain pressure threshold, cervical range of motion and neck disability', 'pain intensity (numeric pain rating scale, NPRS), pressure pain threshold (PPT), cervical range of motion (ROM) and neck disability (neck disability index, NDI', 'Pain', 'pain intensity, PPT, neck disability and cervical ROM', 'Cervical ROM', 'pain intensity', 'NDI', 'PPT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0458343', 'cui_str': 'Trigger point (body structure)'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture (procedure)'}, {'cui': 'C0454525', 'cui_str': 'Manual Therapies'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",101.0,0.15229,Statistically significant differences (P<0.001) in PPT were also found between the intervention group and the control group.,"[{'ForeName': 'Gracia M', 'Initials': 'GM', 'LastName': 'Gallego-Sendarrubias', 'Affiliation': 'Physiotherapy Department, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rodríguez-Sanz', 'Affiliation': 'School of Nursing, Physiotherapy and Podiatry, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Calvo-Lobo', 'Affiliation': 'School of Nursing, Physiotherapy and Podiatry, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Martín', 'Affiliation': 'Simplifying Research Institute, Toledo, Spain.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1136/acupmed-2018-011682']
391,32107817,Effectiveness of WhatsApp online group discussion for smoking relapse prevention: protocol for a pragmatic randomized controlled trial.,"BACKGROUND AND AIMS


Sustained psychosocial support via online social groups may help former tobacco users maintain abstinence. This study aims to examine the effectiveness of participating in a WhatsApp social group for long-term smoking cessation.
DESIGN


Two-arm, open-labelled, pragmatic, individually randomized controlled trial.
SETTING


All participants are service users of smoking cessation clinics, and all interventions are delivered via mobile phones.
PARTICIPANTS


Participants included 1008 adult quitters who self-report no tobacco use in the past 3-30 days.
INTERVENTIONS


The intervention group (n = 504) will join a WhatsApp social group to receive standardized and theory-based reminders of smoking relapse prevention and participate in discussion with other WhatsApp group members using their own mobile phones. All social groups will be led by counselors or specialist nurse practitioners. The control group (n = 504) will receive similar reminders via short messages to their own mobile phones but will not interact with other participants. The intervention duration for both groups is 8 weeks. Both groups will receive a booklet at baseline about how to prevent smoking relapse.
MEASUREMENTS


The primary outcome is biochemically validated tobacco abstinence at 12 months after consent.
COMMENTS


The findings will provide evidence concerning the utility of operating online social group discussion for prevention of smoking relapse and sustaining long-term abstinence.",2020,"The control group (n=504) will receive similar reminders via short messages to their own mobile phones, but will not interact with other participants.","['All participants are service users of smoking cessation clinics, and all interventions are delivered via mobile phones', '1,008 adult quitters who self-report no tobacco use in the past 3 to 30 days']","['WhatsApp online group discussion', 'intervention group (n=504) will join a WhatsApp social group to receive standardized and theory-based reminders of smoking relapse prevention and participate in discussion with other WhatsApp group members using their own mobile phones', 'similar reminders via short messages to their own mobile phones']",['tobacco abstinence'],"[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0687744', 'cui_str': 'Social group (observable entity)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0679867', 'cui_str': 'Relapse Prevention'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}]",1008.0,0.146403,"The control group (n=504) will receive similar reminders via short messages to their own mobile phones, but will not interact with other participants.","[{'ForeName': 'Yee Tak Derek', 'Initials': 'YTD', 'LastName': 'Cheung', 'Affiliation': 'School of Nursing, the University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ching Han Helen', 'Initials': 'CHH', 'LastName': 'Chan', 'Affiliation': 'Integrated Centre on Smoking Cessation, Tung Wah Group of Hospitals, Hong Kong.'}, {'ForeName': 'Kin Sang', 'Initials': 'KS', 'LastName': 'Ho', 'Affiliation': 'Integrated Centre on Smoking Cessation, Tung Wah Group of Hospitals, Hong Kong.'}, {'ForeName': 'Wai-Yin Patrick', 'Initials': 'WP', 'LastName': 'Fok', 'Affiliation': 'Integrated Centre on Smoking Cessation, Tung Wah Group of Hospitals, Hong Kong.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Conway', 'Affiliation': 'Department of Biomedical Informatics, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Carlos King Ho', 'Initials': 'CKH', 'LastName': 'Wong', 'Affiliation': 'Department of Family Medicine and Primary Care, the University of Hong Kong, Hong Kong.'}, {'ForeName': 'William Ho Cheung', 'Initials': 'WHC', 'LastName': 'Li', 'Affiliation': 'School of Nursing, the University of Hong Kong, Hong Kong.'}, {'ForeName': 'Man Ping', 'Initials': 'MP', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, the University of Hong Kong, Hong Kong.'}, {'ForeName': 'Tai Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health, the University of Hong Kong, Hong Kong.'}]","Addiction (Abingdon, England)",['10.1111/add.15027']
392,31610074,A comparative study of engagement in mobile and wearable health monitoring for bipolar disorder.,"OBJECTIVES


Self-monitoring is recommended for individuals with bipolar disorder, with numerous technological solutions available. This study aimed to identify basic components of these solutions that increase engagement with self-monitoring.
METHODS


Participants with bipolar disorder (n = 47) monitored their symptoms with a Fitbit and a smartphone app and were randomly assigned to either review or not review recorded symptoms weekly. We tested whether individuals would better adhere to and prefer monitoring with passive monitoring with an activity tracker compared to active monitoring with a smartphone app and whether individuals would better adhere to self-monitoring if their recorded symptoms were reviewed with an interviewer.
RESULTS


Monitoring with a smartphone app achieved similar adherence and preference to Fitbit (P > .85). Linear mixed effects modeling found adherence decreased significantly more over the study for the Fitbit (12% more, P < .001) even though more participants reported they would use the Fitbit over a year compared to the app (72.3% vs 46.8%). Reviewing symptoms weekly did not improve adherence, but most participants reported they would prefer to review symptoms with a clinician (74.5%) and on monthly basis (57.5%) compared to alternatives. Participants endorsed sleep as the most important symptom to monitor, forgetfulness as the largest barrier to self-monitoring, and raising self-awareness as the best reason for self-monitoring.
CONCLUSIONS


We recommend a combined strategy of wearable and mobile monitoring that includes reminders, targets raising self-awareness, and tracks sleep. A clinician may want to review symptoms on a monthly basis.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03358238.",2020,"Linear mixed effects modeling found adherence decreased significantly more over the study for the Fitbit (12% more, P<0.001) even though more participants reported they would use the Fitbit over a year compared to the app (72.3% vs 46.8%).","['Participants with bipolar disorder (n=47) monitored their symptoms with a Fitbit and a smartphone app', 'individuals with bipolar disorder', 'Bipolar Disorder']",['passive monitoring with an activity tracker'],['adherence'],"[{'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C4264352', 'cui_str': 'Activity Trackers'}]",[],,0.0370131,"Linear mixed effects modeling found adherence decreased significantly more over the study for the Fitbit (12% more, P<0.001) even though more participants reported they would use the Fitbit over a year compared to the app (72.3% vs 46.8%).","[{'ForeName': 'Kaela', 'Initials': 'K', 'LastName': 'Van Til', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Melvin G', 'Initials': 'MG', 'LastName': 'McInnis', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Cochran', 'Affiliation': 'University of Wisconsin-Madison, Madison, WI, USA.'}]",Bipolar disorders,['10.1111/bdi.12849']
393,32085529,"Efficacy and Safety of OnabotulinumtoxinA 400 Units in Patients with Post-Stroke Upper Limb Spasticity: Final Report of a Randomized, Double-Blind, Placebo-Controlled Trial with an Open-Label Extension Phase.","In many countries, 400 units (U) is the maximum dose of onabotulinumtoxinA available to treat upper limb spasticity, but few studies have demonstrated the optimal use of this dose. In the double-blind phase of this randomized, controlled trial, we compared the efficacy and safety of 400 vs. 240 U onabotulinumtoxinA in patients with post-stroke upper limb spasticity. Both groups received 240 U onabotulinumtoxinA injected in the forearm. An additional 160 U onabotulinumtoxinA (400 U group) or placebo (240 U group) was injected in the elbow flexors. Both groups showed similar muscle tone reduction in the wrist, fingers, and thumb; muscle tone reduction in the elbow flexors was greater in the group treated with onabotulinumtoxinA (400 U group) compared to placebo (240 U group). Functional disabilities improved in both groups. No substantial difference was found in safety profiles. In the subsequent open-label phase, all participants received repeat injections of 400 U onabotulinumtoxinA (target muscles and doses per muscle determined by the physician). Similar efficacy and safety outcomes, as with the 400 U group in the double-blind phase, were confirmed. This final report demonstrates that injection of onabotulinumtoxinA 400 U relieves muscle tone in a wide range of areas and improves functional disabilities; generally, it was well-tolerated, and no new safety concerns were identified. The dosing data in the open-label phase will inform optimal use of onabotulinumtoxinA in clinical practice (ClinicalTrials.gov: NCT03261167).",2020,"Both groups showed similar muscle tone reduction in the wrist, fingers, and thumb; muscle tone reduction in the elbow flexors was greater in the group treated with onabotulinumtoxinA (400 U group) compared to placebo (240 U group).","['Patients with Post-Stroke Upper Limb Spasticity', 'patients with post-stroke upper limb spasticity']","['placebo', 'onabotulinumtoxinA', '240 U onabotulinumtoxinA', 'OnabotulinumtoxinA 400 Units', 'Placebo']","['efficacy and safety', 'muscle tone reduction', 'functional disabilities', 'Efficacy and Safety', 'elbow flexors', 'safety profiles', 'Functional disabilities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1273957', 'cui_str': 'Upper limb spasticity'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}, {'cui': 'C0303357', 'cui_str': 'U-240 radioisotope'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549465', 'cui_str': 'Muscle tone (observable entity)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}]",,0.256424,"Both groups showed similar muscle tone reduction in the wrist, fingers, and thumb; muscle tone reduction in the elbow flexors was greater in the group treated with onabotulinumtoxinA (400 U group) compared to placebo (240 U group).","[{'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Abo', 'Affiliation': 'Department of Rehabilitation Medicine, The Jikei University School of Medicine, Tokyo 105-8461, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Shigematsu', 'Affiliation': 'Department of Rehabilitation Medicine, Seirei Hamamatsu City Rehabilitation Hospital, Shizuoka 433-8511, Japan.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Rehabilitation Medicine, Kikyogahara Hospital, Nagano 399-6461, Japan.'}, {'ForeName': 'Yasuko', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'GlaxoSmithKline K.K., Tokyo 107-0052, Japan.'}, {'ForeName': 'Akinori', 'Initials': 'A', 'LastName': 'Nimura', 'Affiliation': 'GlaxoSmithKline K.K., Tokyo 107-0052, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Yamashita', 'Affiliation': 'GlaxoSmithKline K.K., Tokyo 107-0052, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'GlaxoSmithKline K.K., Tokyo 107-0052, Japan.'}]",Toxins,['10.3390/toxins12020127']
394,31512148,"CardioMEMS, the real progress in heart failure home monitoring.","The burden of hospitalizations driven by exacerbation of acute heart failure remains unacceptably high. The associated use of hospital resources drives increasing patient, caregiver, and economic costs. Noninvasive telemedical systems investigated in randomized controlled trials have failed to demonstrate to reduce hospitalization rates probably because of the indirect (non-linear) relationship of the measured biological signals with the patient congestion status. Instead, there is increasing evidence that direct measure of intracardiac and pulmonary artery pressure can effectively guide heart failure management and reduce hospitalizations. Early studies adopting implantable hemodynamic monitors in the right heart unveiled the potential of pressure-based heart failure management, whereas subsequent investigations showed the powerful preemptive approach for heart failure exacerbations. One large randomized trial (CHAMPION) proved that a direct pulmonary pressure monitor system (CardioMEMS) substantially reduced heart failure hospitalizations in subjects randomized to active pulmonary pressure-guided management. The system monitoring safety and efficacy were also excellent. The study proved that early management in response to increased pulmonary pressure is able to provide the most effective therapeutic intervention to prevent heart failure exacerbations.",2020,One large randomized trial (CHAMPION) proved that a direct pulmonary pressure monitor system (CardioMEMS) substantially reduced heart failure hospitalizations in subjects randomized to active pulmonary pressure-guided management.,['subjects randomized to active pulmonary pressure-guided management'],['direct pulmonary pressure monitor system (CardioMEMS'],"['heart failure hospitalizations', 'hospitalization rates']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0182377', 'cui_str': 'Pressure monitor (physical object)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",,0.0433742,One large randomized trial (CHAMPION) proved that a direct pulmonary pressure monitor system (CardioMEMS) substantially reduced heart failure hospitalizations in subjects randomized to active pulmonary pressure-guided management.,"[{'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Gronda', 'Affiliation': ""Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico di Milano UOC di Nefrologia, Dialisi e Trapianto Renale dell'adulto Dipartimento Di Medicina e Specialità Mediche, Milan, Italy. edoardo.gronda@gmail.com.""}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Vanoli', 'Affiliation': 'Department of Molecular Medicine, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Zorzi', 'Affiliation': 'Department of Cardiac Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Corrado', 'Affiliation': 'Department of Cardiac Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.'}]",Heart failure reviews,['10.1007/s10741-019-09840-y']
395,31781387,"Changes in Circulating BDNF in relation to Sex, Diet, and Exercise: A 12-Week Randomized Controlled Study in Overweight and Obese Participants.","Circulating BDNF is higher in women than in men and suggested to be affected by changes in food intake, body weight, and exercise. The purpose of this study was to compare BDNF concentrations in women and men during a 12-week weight loss intervention. Using a previously published 12-week randomized study, serum BDNF was assessed at baseline and after 12 weeks using an enzyme-linked immunosorbent assay method. Fifty overweight or obese but healthy individuals (26 women, mean age of 36.4 ± 7.9 years; 24 men, mean age of 38.0 ± 5.9 years) were included and allocated into three groups: exercise-only (EXO; 12 weeks of aerobic exercise and isocaloric diet), diet-only (DIO; 8 weeks of very low energy diet (VLED 600 kcal/day) followed by a 4-week weight maintenance diet), or diet and exercise (DEX; 12 weeks of aerobic exercise in parallel with 8 weeks of VLED (800 kcal/day) followed by a 4-week weight maintenance diet). At baseline, BDNF levels were 25% higher in women compared to men ( p =0.006). Body weight was reduced in all intervention groups ( p  < 0.006). Exercise (EXO group) induced a 22% reduction in circulating BDNF in men ( p =0.037) and women ( p =0.080). In the DIO and DEX groups, a significant reduction in BDNF levels (29.9%;  p =0.035 and 32.5%;  p =0.003, respectively) was observed in women but not in men. In conclusion, circulating BDNF was significantly changed by diet alone or combined with exercise in women and only by exercise alone in men. This suggests that changes in circulating BDNF depend on weight loss methods (diet/exercise) as well as sex.",2019,Exercise (EXO group) induced a 22% reduction in circulating BDNF in men ( p =0.037) and women ( p =0.080).,"['Fifty overweight or obese but healthy individuals (26 women, mean age of 36.4\u2009±\u20097.9 years; 24 men, mean age of 38.0\u2009±\u20095.9 years', 'Overweight and Obese Participants', 'women and men during a 12-week weight loss intervention']","['exercise-only (EXO; 12 weeks of aerobic exercise and isocaloric diet), diet-only (DIO; 8 weeks of very low energy diet (VLED 600\u2009kcal/day) followed by a 4-week weight maintenance diet), or diet and exercise (DEX; 12 weeks of aerobic exercise in parallel with 8 weeks of VLED', 'DEX']","['serum BDNF', 'BDNF concentrations', 'circulating BDNF', 'Circulating BDNF', 'Body weight', 'BDNF levels']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0854076', 'cui_str': 'DIOS'}, {'cui': 'C0452268', 'cui_str': 'Very low energy diet (finding)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0456649', 'cui_str': 'kcal/day'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0311129', 'cui_str': 'Weight maintenance regimen'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",26.0,0.0202807,Exercise (EXO group) induced a 22% reduction in circulating BDNF in men ( p =0.037) and women ( p =0.080).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Glud', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Christiansen', 'Affiliation': 'Department of Endocrinology and Internal Medicine (MEA), Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'L H', 'Initials': 'LH', 'LastName': 'Larsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Richelsen', 'Affiliation': 'Department of Endocrinology and Internal Medicine (MEA), Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Bruun', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg, Denmark.'}]",Journal of obesity,['10.1155/2019/4537274']
396,31654469,Exploring Malaysian mothers' plans on sleeping arrangement with their newborn.,"AIM


Bed sharing is defined as a newborn sleeping in the same bed with an adult. Bed sharing may put the newborn at risk of suffocation due to accidental smothering.
METHODS


This was a quasi-experimental study conducted in a tertiary referral hospital. Healthy post-delivery Malaysian mothers were randomly selected and enrolled into the control or the intervention group. On the day of discharge, mothers in the intervention group were interviewed face-to-face in the post-natal ward on their plans for sleeping arrangement with their newborn. After the interview, mothers were advised not to bed share with their newborn and were given an educational leaflet on safe sleeping practices. One week after discharge, mothers in both groups were interviewed over the telephone regarding their actual sleeping arrangements with their newborn using the same questionnaire. Logistic regression was performed to determine factors associated with reduced bed sharing.
RESULTS


A total of 94 mothers and 95 mothers were recruited to the control and intervention group, respectively. The baseline bed-sharing prevalence was similar between groups: 60.6% in the control group and 61.1% in the interventional group. The proportion of mothers who bed shared with their newborn reduced from 61.1 to 37.9% after the intervention (P < 0.001). Most mothers in the control group opted for bed sharing to ease breastfeeding (68.4%). Mothers in the control group had a 5.9 times higher odds of bed sharing.
CONCLUSIONS


In this study, the majority of mothers practiced bed sharing at baseline. A significant proportion of mothers changed their sleeping practices after receiving the intervention in the form of an information leaflet.",2020,The baseline bed-sharing prevalence was similar between groups: 60.6% in the control group and 61.1% in the interventional group.,"['94 mothers and 95 mothers', ""Exploring Malaysian mothers' planson sleeping arrangement with their newborn"", 'Healthy post-delivery Malaysian mothers']",[],"['proportion of mothers who bed shared with their newborn', 'baseline bed-sharing prevalence']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]",[],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C2721684', 'cui_str': 'Bed sharing'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",94.0,0.0290046,The baseline bed-sharing prevalence was similar between groups: 60.6% in the control group and 61.1% in the interventional group.,"[{'ForeName': 'Chee-Tao', 'Initials': 'CT', 'LastName': 'Chang', 'Affiliation': 'Clinical Research Centre, Hospital Raja Permaisuri Bainun, Ministry of Health Malaysia, Ipoh, Malaysia.'}, {'ForeName': 'Pavithrah', 'Initials': 'P', 'LastName': 'Shunmugam', 'Affiliation': 'Clinical Research Centre, Hospital Raja Permaisuri Bainun, Ministry of Health Malaysia, Ipoh, Malaysia.'}, {'ForeName': 'Noor Azmatulakma', 'Initials': 'NA', 'LastName': 'Abdul Aziz', 'Affiliation': 'Allied Health Science College Sultan Azlan Shah, Ministry of Health Malaysia, Tanjung Rambutan, Malaysia.'}, {'ForeName': 'Noor Shahizan', 'Initials': 'NS', 'LastName': 'Abdul Razak', 'Affiliation': 'Allied Health Science College Sultan Azlan Shah, Ministry of Health Malaysia, Tanjung Rambutan, Malaysia.'}, {'ForeName': 'Nurhidayatun', 'Initials': 'N', 'LastName': 'Johari', 'Affiliation': 'Allied Health Science College Sultan Azlan Shah, Ministry of Health Malaysia, Tanjung Rambutan, Malaysia.'}, {'ForeName': 'Norazra', 'Initials': 'N', 'LastName': 'Mohamad', 'Affiliation': 'Allied Health Science College Sultan Azlan Shah, Ministry of Health Malaysia, Tanjung Rambutan, Malaysia.'}, {'ForeName': 'Roswati', 'Initials': 'R', 'LastName': 'Ghazali', 'Affiliation': 'Allied Health Science College Sultan Azlan Shah, Ministry of Health Malaysia, Tanjung Rambutan, Malaysia.'}, {'ForeName': 'Haymalatha', 'Initials': 'H', 'LastName': 'Rajagam', 'Affiliation': 'Allied Health Science College Sultan Azlan Shah, Ministry of Health Malaysia, Tanjung Rambutan, Malaysia.'}, {'ForeName': 'Amar-Singh', 'Initials': 'AS', 'LastName': 'Hss', 'Affiliation': 'Clinical Research Centre, Hospital Raja Permaisuri Bainun, Ministry of Health Malaysia, Ipoh, Malaysia.'}]",Journal of paediatrics and child health,['10.1111/jpc.14646']
397,31463874,Removal of DNA-fragmented spermatozoa using flow cytometry and sorting does not improve the outcome of intracytoplasmic sperm injection.,"PURPOSE


The DNA fragmentation in sperm is associated with reduced outcome in assisted reproduction. Using YoPro1 as the staining dye and flow cytometry and sorting (FACS), the number of spermatozoa with DNA fragmentation can be lowered to 5%. Can the cumulative outcome of ICSI be improved using FACS?
METHODS


A prospective, randomized, double-blind clinical trial was conducted in 104 infertile couples with male infertility based on abnormal conventional semen analysis results. Cumulative ongoing pregnancy rate was the primary outcome parameter. In 52 cases, semen was processed for ICSI using swim-up. In another 52 cases, spermatozoa with fragmented DNA were removed with FACS.
RESULTS


The cumulative pregnancy rate at 12 weeks of gestation (51.9% versus 46.2%) and live birth rate (42.3% versus 34.6%) were higher and the miscarriage rate was lower (27.8% versus 35.3%) after FACS-sorting as compared with swim-up. An interim analysis scheduled before initiation of the study after 100 cases demonstrated that the aim of a 20% gain in pregnancy rate could not be achieved. For that reason, the prospective study was stopped prematurely.
CONCLUSIONS


A trend towards consistently better results was achieved by removing spermatozoa with fragmented DNA. The fragmentation of the DNA in sperm is the end stage of apoptosis. Sorting of spermatozoa may be improved by selecting parameters of processes active more upstream of apoptosis, such as chromatin decondensation.
TRIAL REGISTRATION


NCT02166567 . June 14, 2014.",2019,The cumulative pregnancy rate at 12 weeks of gestation (51.9% versus 46.2%) and live birth rate (42.3% versus 34.6%) were higher and the miscarriage rate was lower (27.8% versus 35.3%) after FACS-sorting as compared with swim-up.,['104 infertile couples with male infertility based on abnormal conventional semen analysis results'],[],"['Cumulative ongoing pregnancy rate', 'pregnancy rate', 'cumulative pregnancy rate', 'live birth rate', 'miscarriage rate']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0021364', 'cui_str': 'Male infertility (disorder)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",[],"[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}]",,0.368995,The cumulative pregnancy rate at 12 weeks of gestation (51.9% versus 46.2%) and live birth rate (42.3% versus 34.6%) were higher and the miscarriage rate was lower (27.8% versus 35.3%) after FACS-sorting as compared with swim-up.,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'De Geyter', 'Affiliation': 'Reproductive Medicine and Gynecological Endocrinology (RME), University Hospital, University of Basel, Vogesenstrasse 134, CH-4031, Basel, Switzerland. christian.degeyter@usb.ch.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Gobrecht-Keller', 'Affiliation': 'Reproductive Medicine and Gynecological Endocrinology (RME), University Hospital, University of Basel, Vogesenstrasse 134, CH-4031, Basel, Switzerland.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Ahler', 'Affiliation': 'Reproductive Medicine and Gynecological Endocrinology (RME), University Hospital, University of Basel, Vogesenstrasse 134, CH-4031, Basel, Switzerland.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Fischer', 'Affiliation': 'Reproductive Medicine and Gynecological Endocrinology (RME), University Hospital, University of Basel, Vogesenstrasse 134, CH-4031, Basel, Switzerland.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-019-01571-1']
398,32023608,Depressive Symptoms in Stroke Patients: Are There Sex Differences?,"BACKGROUND


We aimed to examine sex differences in symptom characteristics and pharmacological responses in post-stroke depressive (PSD) symptoms.
METHODS


This is a post hoc analysis of EMOTION (ClinicalTrials.gov, NCT01278498), a randomized, placebo-controlled, double-blind trial that examined the efficacy of escitalopram for 3 months on depression in patients with acute stroke. Depressive symptoms were evaluated using the 10-item Montgomery-Åsberg Depression Rating Scale (MADRS). Baseline characteristics, clinical variables, and treatment responses to escitalopram were compared between male and female patients. Treatment responses were defined as changes in MADRS (total score and its components) between baseline and 3 months and were compared between the escitalopram and placebo groups within each sex group. The least square mean was calculated to determine the independent effect of escitalopram, of which interaction was evaluated with patient sex.
RESULTS


Of the 478 patients (intention-to-treat population), 187 (39%) were female. Female patients were significantly older than male patients and demonstrated more severe depressive symptoms at baseline (male vs. female, MADRS score, mean [SD]: 9.7 ± 8.0 vs. 12.2 ± 8.4, p = 0.001), especially in apparent sadness, reported sadness, and reduced appetite items. These differences were significant after adjustment for age and the severity of neurologic deficits. The female escitalopram group showed a significant 3-month improvement in MADRS scores (placebo [n = 86] vs. escitalopram [n = 101], least square mean [95% CI] -2.7 [-4.1 to -1.2] vs. -5.0 [-6.4 to -3.6], p = 0.007), and this efficacy was prominent in apparent sadness, reported sadness, and pessimistic thoughts items. However, there was no significant effect of escitalopram on depressive symptoms in the male group. The treatment responses of escitalopram tended to be more pronounced in the female group, particularly in alleviating a subset of depressive symptoms such as apparent sadness (p for interaction = 0.009).
CONCLUSION


PSD may differ according to sex in its symptom characteristics and treatment responses to escitalopram, and tailored treatment strategies for PSD may therefore be needed.",2020,"Female patients were significantly older than male patients and demonstrated more severe depressive symptoms at baseline (male vs. female, MADRS score, mean [SD]: 9.7 ± 8.0 vs. 12.2 ± 8.4, p = 0.001), especially in apparent sadness, reported sadness, and reduced appetite items.","['Stroke Patients', '478 patients (intention-to-treat population), 187 (39%) were female', 'patients with acute stroke', 'post-stroke depressive (PSD) symptoms', 'male and female patients']","['placebo', 'escitalopram']","['MADRS scores', 'severe depressive symptoms', '10-item Montgomery-Åsberg Depression Rating Scale (MADRS', 'changes in MADRS (total score and its components', 'Depressive Symptoms', 'depressive symptoms', 'Depressive symptoms']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]",478.0,0.428279,"Female patients were significantly older than male patients and demonstrated more severe depressive symptoms at baseline (male vs. female, MADRS score, mean [SD]: 9.7 ± 8.0 vs. 12.2 ± 8.4, p = 0.001), especially in apparent sadness, reported sadness, and reduced appetite items.","[{'ForeName': 'Eun-Jae', 'Initials': 'EJ', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, University of Ulsan, Asan Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jong S', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, University of Ulsan, Asan Medical Center, Seoul, Republic of Korea, jongskim@amc.seoul.kr.'}, {'ForeName': 'Dae-Il', 'Initials': 'DI', 'LastName': 'Chang', 'Affiliation': 'Department of Neurology, Kyung Hee University Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jong-Ho', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Hanyang University, Myongji Hospital, Goyang-si, Republic of Korea.'}, {'ForeName': 'Seong Hwan', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Department of Neurology, Chosun University Hospital, Gwangju, Republic of Korea.'}, {'ForeName': 'Jae-Kwan', 'Initials': 'JK', 'LastName': 'Cha', 'Affiliation': 'Department of Neurology, Dong-A University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Ji Hoe', 'Initials': 'JH', 'LastName': 'Heo', 'Affiliation': 'Department of Neurology, Yonsei University, Severance Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Sung-Il', 'Initials': 'SI', 'LastName': 'Sohn', 'Affiliation': 'Department of Neurology, Keimyung University, Dongsan Medical Center, Daegu, Republic of Korea.'}, {'ForeName': 'Byung-Chul', 'Initials': 'BC', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Hallym University, Sacred Heart Hospital, Pyungchon, Republic of Korea.'}, {'ForeName': 'Dong-Eog', 'Initials': 'DE', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Dongguk University, Ilsan hospital, Goyang-si, Republic of Korea.'}, {'ForeName': 'Hahn Young', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Konkuk University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seongheon', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Kangwon National University College of Medicine, Chuncheon-si, Republic of Korea.'}, {'ForeName': 'Do-Young', 'Initials': 'DY', 'LastName': 'Kwon', 'Affiliation': 'Department of Neurology, Korea University, Ansan Hospital, Ansan-si, Republic of Korea.'}, {'ForeName': 'Jei', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Chungnam University Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'Woo-Keun', 'Initials': 'WK', 'LastName': 'Seo', 'Affiliation': 'Department of Neurology, Sungkyunkwan University, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Yeungnam University Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Sang-Won', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Daegu Fatima Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Seong-Ho', 'Initials': 'SH', 'LastName': 'Koh', 'Affiliation': 'Department of Neurology, Hanyang University, Guri Hospital, Guri-si, Republic of Korea.'}, {'ForeName': 'Jin Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Hyundai Hospital, Eumseong, Republic of Korea.'}, {'ForeName': 'Smi', 'Initials': 'S', 'LastName': 'Choi-Kwon', 'Affiliation': 'College of Nursing, The Research Institute of Nursing Science, Seoul National University, Seoul, Republic of Korea.'}]","Cerebrovascular diseases (Basel, Switzerland)",['10.1159/000506116']
399,31257623,Baseline training sequence affects speed of emergent conditional discriminations.,"We examined the effects of baseline training sequence on the emergence of conditional discriminations in an intraverbal naming task. Thirty-two college students were randomly assigned to two groups. The tact-intraverbal (TI) group first learned to vocally tact eight visual stimuli using a unique verbal label for each stimulus, and then to intraverbally relate four pairs of verbal labels. The intraverbal-tact (IT) group received the same training but in the opposite sequence. Both groups then received a match-to-sample test involving the visual stimuli alone. On average, the TI group had significantly shorter reaction times than the IT group throughout all four test blocks, even when controlling for intraverbal retention, which was lower in the IT group. Accuracy on the MTS test did not differ significantly between groups when controlling for intraverbal retention. However, MTS accuracy and intraverbal retention were strongly correlated in the IT group but uncorrelated in the TI group. We suggest the effect of training sequence reflects different sources of stimulus control available to subjects in different groups when confronted with the novel MTS trials.",2019,"On average, the TI group had significantly shorter reaction times than the IT group throughout all four test blocks, even when controlling for intraverbal retention, which was lower in the IT group.",['Thirty-two college students'],['tact-intraverbal (TI) group first learned to vocally tact eight visual stimuli using a unique verbal label'],"['MTS accuracy and intraverbal retention', 'shorter reaction times']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0618927', 'cui_str': 'TACT'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449880', 'cui_str': 'Stimulus used (attribute)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",32.0,0.0157288,"On average, the TI group had significantly shorter reaction times than the IT group throughout all four test blocks, even when controlling for intraverbal retention, which was lower in the IT group.","[{'ForeName': 'Anna Ingeborg', 'Initials': 'AI', 'LastName': 'Petursdottir', 'Affiliation': 'Texas Christian University.'}, {'ForeName': 'Reagan E', 'Initials': 'RE', 'LastName': 'Cox', 'Affiliation': 'Texas Christian University.'}, {'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'McKeon', 'Affiliation': 'Texas Christian University.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Mellor', 'Affiliation': 'Texas Christian University.'}]",Journal of the experimental analysis of behavior,['10.1002/jeab.539']
400,32164703,Children and parents' perspectives on the acceptability of three management strategies for dental caries in primary teeth within the 'Filling Children's Teeth: Indicated or Not' (FiCTION) randomised controlled trial - a qualitative study.,"BACKGROUND


The Filling Children's Teeth: Indicated Or Not? (FiCTION) randomised controlled trial (RCT) aimed to explore the clinical- and cost-effectiveness of managing dental caries in children's primary teeth. The trial compared three management strategies: conventional caries management with best practice prevention (C + P), biological management with best practice prevention (B + P) and best practice prevention alone (PA)-based approaches. Recently, the concept of treatment acceptability has gained attention and attempts have been made to provide a conceptual definition, however this has mainly focused on adults. Recognising the importance of evaluating the acceptability of interventions in addition to their effectiveness, particularly for multi-component complex interventions, the trial design included a qualitative component. The aim of this component was to explore the acceptability of the three strategies from the perspectives of the child participants and their parents.
METHODS


Qualitative exploration, based on the concept of acceptability. Participants were children already taking part in the FiCTION trial and their parents. Children were identified through purposive maximum variation sampling. The sample included children from the three management strategy arms who had been treated and followed up; median (IQR) follow-up was at 33.8 (23.8, 36.7) months. Semi-structured interviews with thirteen child-parent dyads. Interviews were transcribed verbatim and analysed using a framework approach.
RESULTS


Data saturation was reached after thirteen interviews. Each child-parent dyad took part in one interview together. The participants were eight girls and five boys aged 5-11 years and their parents. The children's distribution across the trial arms was: C + P n = 4; B + P n = 5; PA n = 4. Three key factors influenced the acceptability of caries management in primary teeth to children and parents: i) experiences of specific procedures within management strategies; ii) experiences of anticipatory dental anxiety and; iii) perceptions of effectiveness (particularly whether pain was reduced). These factors were underpinned by a fourth key factor: the notion of trust in the dental professionals - this was pervasive across all arms.
CONCLUSIONS


Overall children and parents found each of the three strategies for the management of dental caries in primary teeth acceptable, with trust in the dental professional playing an important role.",2020,"CONCLUSIONS


Overall children and parents found each of the three strategies for the management of dental caries in primary teeth acceptable, with trust in the dental professional playing an important role.","['child participants and their parents', 'sample included children from the three management strategy arms who had been treated and followed up; median (IQR) follow-up was at 33.8 (23.8, 36.7) months', 'Participants were children already taking part in the FiCTION trial and their parents', ""dental caries in primary teeth within the 'Filling Children's Teeth"", ""children's primary teeth"", ""Filling Children's Teeth"", 'participants were eight girls and five boys aged 5-11\u2009years and their parents']","['conventional caries management with best practice prevention (C\u2009+\u2009P), biological management with best practice prevention (B\u2009+\u2009P) and best practice prevention alone (PA)-based approaches']",['acceptability of caries management'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0011334', 'cui_str': 'Dental Decay'}, {'cui': 'C3266841', 'cui_str': 'Baby Teeth'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}]",8.0,0.0496609,"CONCLUSIONS


Overall children and parents found each of the three strategies for the management of dental caries in primary teeth acceptable, with trust in the dental professional playing an important role.","[{'ForeName': 'Sarab', 'Initials': 'S', 'LastName': 'El-Yousfi', 'Affiliation': 'School of Clinical Dentistry, Claremont Crescent, Sheffield, S10 2TA, UK.'}, {'ForeName': 'Nicola P T', 'Initials': 'NPT', 'LastName': 'Innes', 'Affiliation': 'School of Dentistry, University of Dundee, Park Place, Dundee, DD1 4HN, UK. n.p.Innes@dundee.ac.uk.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Holmes', 'Affiliation': 'School of Dental Sciences, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, NE2 4HH, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Freeman', 'Affiliation': 'School of Dentistry, University of Dundee, Park Place, Dundee, DD1 4HN, UK.'}, {'ForeName': 'Kathryn B', 'Initials': 'KB', 'LastName': 'Cunningham', 'Affiliation': 'School of Medicine, University of St Andrews, North Haugh, St Andrews, KY16 9TF, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'McColl', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Maguire', 'Affiliation': 'School of Dental Sciences, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, NE2 4HH, UK.'}, {'ForeName': 'Gail V A', 'Initials': 'GVA', 'LastName': 'Douglas', 'Affiliation': 'University of Leeds School of Dentistry, Clarendon Way, Leeds, LS2 9LU, UK.'}, {'ForeName': 'Janet E', 'Initials': 'JE', 'LastName': 'Clarkson', 'Affiliation': 'Dental Health Services Research Unit, School of Dentistry, Park Place, Dundee, DD1 4HN, UK.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Marshman', 'Affiliation': 'School of Clinical Dentistry, Claremont Crescent, Sheffield, S10 2TA, UK.'}]",BMC oral health,['10.1186/s12903-020-1060-6']
401,31488494,Neonatal azithromycin administration to prevent infant mortality: study protocol for a randomised controlled trial.,"INTRODUCTION


Biannual mass azithromycin distribution to children aged 1-59 months has been shown to reduce all-cause mortality. Children under 28 days of age were not treated in studies evaluating mass azithromycin distribution for child mortality due to concerns related to infantile hypertrophic pyloric stenosis (IHPS). Here, we report the design of a randomised controlled trial to evaluate the efficacy and safety of administration of a single dose of oral azithromycin during the neonatal period.
METHODS AND ANALYSIS


The  Nouveaux-nés et Azithromycine: une Innovation dans le Traitement des Enfants  (NAITRE) study is a double-masked randomised placebo-controlled trial designed to evaluate the efficacy of a single dose of azithromycin (20 mg/kg) for the prevention of child mortality. Newborns (n=21 712) aged 8-27 days weighing at least 2500 g are 1:1 randomised to a single, directly observed, oral dose of azithromycin or matching placebo. Participants are followed weekly for 3 weeks after treatment to screen for adverse events, including IHPS. The primary outcome is all-cause mortality at the 6-month study visit.
ETHICS AND DISSEMINATION


This study was approved by the Institutional Review Boards at the University of California, San Francisco in San Francisco, USA (Protocol #18-25027) and the Comité National d'Ethique pour la Recherche in Ouagadougou, Burkina Faso (Protocol #2018-10-123). The findings of this trial will be presented at local, regional and international meetings and published in open access peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT03682653; Pre-results.",2019,"INTRODUCTION


Biannual mass azithromycin distribution to children aged 1-59 months has been shown to reduce all-cause mortality.","['Newborns (n=21 712) aged 8-27 days weighing at least 2500 g', 'Institutional Review Boards at the University of California, San Francisco in San Francisco']","['oral azithromycin', 'Neonatal azithromycin', 'azithromycin or matching placebo', 'placebo', 'USA', 'azithromycin']","['cause mortality', 'efficacy and safety', 'infant mortality', 'infantile hypertrophic pyloric stenosis (IHPS']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4319601', 'cui_str': '2500 (qualifier value)'}, {'cui': 'C0086911', 'cui_str': 'Institutional Review Boards'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021278', 'cui_str': 'Infant Mortality'}, {'cui': 'C1867403', 'cui_str': 'Pyloric Stenosis, Infantile Hypertrophic'}]",,0.587863,"INTRODUCTION


Biannual mass azithromycin distribution to children aged 1-59 months has been shown to reduce all-cause mortality.","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sie', 'Affiliation': 'Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Mamadou', 'Initials': 'M', 'LastName': 'Bountogo', 'Affiliation': 'Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Nebie', 'Affiliation': 'Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Mamadou', 'Initials': 'M', 'LastName': 'Ouattara', 'Affiliation': 'Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Boubacar', 'Initials': 'B', 'LastName': 'Coulibaly', 'Affiliation': 'Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Cheik', 'Initials': 'C', 'LastName': 'Bagagnan', 'Affiliation': 'Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Zabre', 'Affiliation': 'Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lebas', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, California, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Brogdon', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, California, USA.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Godwin', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, California, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, California, USA.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Porco', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, California, USA.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Doan', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, California, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, California, USA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, California, USA catherine.oldenburg@ucsf.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-031162']
402,31089425,Effects of Exercise Domain and Intensity on Sleep in Women and Men with Overweight and Obesity.,"Inadequate sleep is associated with cardiometabolic risk and adiposity. Exercise has been suggested as an efficient strategy to improve sleep; however, the effects of different types of exercise on sleep in individuals with overweight and obesity are not well understood. We examined effects of active commuting and leisure-time exercise on sleep in individuals with overweight or obesity. 130 physically inactive adults (20-45 years) with overweight or class 1 obesity (body mass index: 25-35 kg/m 2 ) were randomized to 6 months of habitual lifestyle (CON,  n  = 18), active commuting by bike (BIKE,  n  = 35), or leisure-time exercise of moderate intensity (MOD, 50% VO 2 peak-reserve,  n  = 39) or vigorous intensity (VIG, 70% VO 2 peak-reserve,  n  = 38), 5 days/week. Sleep was assessed from 7-day/night accelerometry and questionnaires at baseline, 3 months, and 6 months. 92 participants were included in a  per protocol  analysis. At 3 months, sleep duration was longer in VIG (29 min/night [3; 55] (mean [95% CI]),  p =0.03) but not in BIKE and MOD ( p  ≥ 0.11) compared with CON and was not different between groups at 6 months ( p  ≥ 0.36 vs. CON). At 6 months, sleep duration variability was lower in MOD (-31% [-50; -3],  p =0.03) and numerically lower in VIG (-28% [-49; 1],  p =0.06) relative to CON but was unchanged in BIKE ( p =0.17 vs. CON). The effects were, however, primarily attributable to shorter and more irregular sleep in CON over time. Our findings suggest that effects of exercise on sleep in individuals with overweight and obesity may be restricted to leisure-time exercise with a short-term effect on sleep duration after vigorous intensity exercise (3 months) but a more regular sleep pattern after 6 months of moderate and vigorous intensity exercise compared with physically inactive controls. This trial was registered at clinicaltrials.gov with ID NCT01962259.",2019,"At 6 months, sleep duration variability was lower in MOD (-31% [","['130 physically inactive adults (20-45\u2009years) with overweight or class 1 obesity (body mass index: 25-35\u2009kg/m 2 ', 'individuals with overweight or obesity', '92 participants were included in a  per protocol  analysis', 'Women and Men with Overweight and Obesity', 'individuals with overweight and obesity']","['exercise', 'habitual lifestyle (CON,  n \u2009=\u200918), active commuting by bike (BIKE,  n \u2009=\u200935), or leisure-time exercise of moderate intensity (MOD, 50% VO 2 peak-reserve,  n \u2009=\u200939) or vigorous intensity (VIG', 'Exercise Domain and Intensity', 'active commuting and leisure-time exercise']","['Sleep', 'irregular sleep', 'sleep duration variability', 'BIKE and MOD', 'sleep duration']","[{'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0026766', 'cui_str': 'Organ Dysfunction Syndrome, Multiple'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0205271', 'cui_str': 'Irregular (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}, {'cui': 'C0026766', 'cui_str': 'Organ Dysfunction Syndrome, Multiple'}]",130.0,0.0904726,"At 6 months, sleep duration variability was lower in MOD (-31% [","[{'ForeName': 'Jonas Salling', 'Initials': 'JS', 'LastName': 'Quist', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Rosenkilde', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne Sofie', 'Initials': 'AS', 'LastName': 'Gram', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Martin Bæk', 'Initials': 'MB', 'LastName': 'Blond', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Holm-Petersen', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mads Fiil', 'Initials': 'MF', 'LastName': 'Hjorth', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Stallknecht', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Sjödin', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}]",Journal of obesity,['10.1155/2019/2189034']
403,31928949,Magnetoencephalographic Correlates of Suicidal Ideation in Major Depression.,"BACKGROUND


Defining the neurobiological underpinnings of suicidal ideation (SI) is crucial to improving our understanding of suicide. This study used magnetoencephalographic gamma power as a surrogate marker for population-level excitation-inhibition balance to explore the underlying neurobiology of SI and depression. In addition, effects of pharmacological intervention with ketamine, which has been shown to rapidly reduce SI and depression, were assessed.
METHODS


Data were obtained from 29 drug-free patients with major depressive disorder who participated in an experiment comparing subanesthetic ketamine (0.5 mg/kg) with a placebo saline infusion. Magnetoencephalographic recordings were collected at baseline and after ketamine and placebo infusions. During scanning, patients rested with their eyes closed. SI and depression were assessed, and a linear mixed-effects model was used to identify brain regions where gamma power and both SI and depression were associated. Two regions of the salience network (anterior insula, anterior cingulate) were then probed using dynamic causal modeling to test for ketamine effects.
RESULTS


Clinically, patients showed significantly reduced SI and depression after ketamine administration. In addition, distinct regions in the anterior insula were found to be associated with SI compared with depression. In modeling of insula-anterior cingulate connectivity, ketamine lowered the membrane capacitance for superficial pyramidal cells. Finally, connectivity between the insula and anterior cingulate was associated with improvements in depression symptoms.
CONCLUSIONS


These findings suggest that the anterior insula plays a key role in SI, perhaps via its role in salience detection. In addition, transient changes in superficial pyramidal cell membrane capacitance and subsequent increases in cortical excitability might be a mechanism through which ketamine improves SI.",2020,"Finally, connectivity between the insula and anterior cingulate was associated with improvements in depression symptoms.
","['Suicidal Ideation in Major Depression', '0.5 mg/kg) with a', 'Data were obtained from 29 drug-free patients with major depressive disorder who participated in an experiment comparing']","['ketamine', 'subanesthetic ketamine', 'placebo saline infusion', 'ketamine and placebo']","['Magnetoencephalographic recordings', 'cortical excitability', 'SI and depression', 'depression symptoms']","[{'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0665465,"Finally, connectivity between the insula and anterior cingulate was associated with improvements in depression symptoms.
","[{'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Gilbert', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland. Electronic address: jessica.gilbert@nih.gov.'}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Ballard', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'Galiano', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland.'}]",Biological psychiatry. Cognitive neuroscience and neuroimaging,['10.1016/j.bpsc.2019.11.011']
404,32173214,"Effects of a short health education intervention on physical activity, arterial stiffness and cardiac autonomic function in individuals with moderate-to-high cardiovascular risk.","OBJECTIVE


This study evaluated the effects of a short health education and counseling intervention program, in a primary healthcare setting, on daily physical activity (PA), arterial stiffness, and cardiac autonomic function in individuals with moderate-to-high risk of cardiovascular disease.
METHODS


This was a parallel-group study with a 4-month-long intervention, plus 8 months of follow-up. 164 individuals with moderate-to-high cardiovascular risk were allocated to either an intervention (n = 87) or a control group (n = 77). The intervention consisted of 3 walking and face-to-face group sessions plus text messages. Primary outcome was daily PA (sedentary time, light and moderate-to-vigorous PA, all in min/day); secondary outcomes were arterial stiffness i.e., carotid-femoral pulse wave velocity (cfPWV, m/s)] and cardiac autonomic function [(i.e., standard deviation of all N-N intervals (SDNN, ms) and absolute high frequency (HF, ms 2 )].
RESULTS


There were not significant group*time interactions for sedentary time [-7.4 (7.6); p = 0.331)], light PA [4.4 (6.4); p = 0.491] or moderate-to-vigorous PA [0.1 (2.6); p = 0.938]. Considering secondary outcomes, there were not significant group*time interactions for cfPWV [0.09 (0.18); p = 0.592], Ln_SDNN [0.09 (0.06); p = 0.148], or Ln_HF [0.16 (0.14); p = 0.263].
CONCLUSION


The program did not improve daily PA, arterial stiffness, or the autonomic cardiac function.
PRACTICE IMPLICATIONS


Primary care staff should consider longer or other types of intervention to improve daily PA.",2020,"There were not significant group*time interactions for sedentary time [-7.4 (7.6); p = 0.331)], light PA [4.4 (6.4); p = 0.491] or moderate-to-vigorous PA [0.1 (2.6); p = 0.938].","['individuals with moderate-to-high cardiovascular risk', '164 individuals with moderate-to-high cardiovascular risk', 'individuals with moderate-to-high risk of cardiovascular disease']","['3 walking and face-to-face group sessions plus text messages', 'short health education intervention', 'short health education and counseling intervention program']","['daily physical activity (PA), arterial stiffness, and cardiac autonomic function', 'daily PA (sedentary time, light and moderate-to-vigorous PA, all in min/day); secondary outcomes were arterial stiffness i.e., carotid-femoral pulse wave velocity (cfPWV, m/s)] and cardiac autonomic function [(i.e., standard deviation of all N-N intervals (SDNN, ms) and absolute high frequency (HF, ms 2 ', 'daily PA, arterial stiffness, or the autonomic cardiac function', 'physical activity, arterial stiffness and cardiac autonomic function', 'light PA']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]","[{'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0018701'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0556973', 'cui_str': 'mins/day'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0232148', 'cui_str': 'Femoral pulse, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0439493', 'cui_str': 'meter/second'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}]",164.0,0.0307433,"There were not significant group*time interactions for sedentary time [-7.4 (7.6); p = 0.331)], light PA [4.4 (6.4); p = 0.491] or moderate-to-vigorous PA [0.1 (2.6); p = 0.938].","[{'ForeName': 'Lucimére', 'Initials': 'L', 'LastName': 'Bohn', 'Affiliation': 'Research Centre in Physical Activity, Health and Leisure. Faculty of Sport, University of Porto, Rua Dr. Plácido Costa, 91, 4200.450, Porto, Portugal. Electronic address: lucimerebohn@fade.up.pt.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Sa-Couto', 'Affiliation': 'Center for Research and Development in Mathematics and Applications (CIDMA), Department of Mathematics (DMAT), University of Aveiro, Aveiro, Portugal. Electronic address: p.sa.couto@ua.pt.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ramoa Castro', 'Affiliation': 'Primary Care Centre Espaço Saúde, Aldoar, Porto, Portugal. Electronic address: anaramoacastro@gmail.com.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Ribeiro', 'Affiliation': 'School of Health Sciences and Institute of Biomedicine-iBiMED, University of Aveiro, Aveiro, Portugal. Electronic address: fernando.ribeiro@ua.pt.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Oliveira', 'Affiliation': 'Faculty of Sport, University of Porto, Research Centre in Physical Activity, Health and Leisure, Porto, Portugal. Electronic address: joliveira@fade.up.pt.'}]",Patient education and counseling,['10.1016/j.pec.2020.03.005']
405,32168290,Tablet-Based Decision Support Tool Improves Performance of Neonatal Resuscitation: A Randomized Trial in Simulation.,"INTRODUCTION


Decision support tools (DST) may aid compliance of teams with the Neonatal Resuscitation Program (NRP) algorithm but have not been adequately tested in this population. Furthermore, the optimal team size for neonatal resuscitation is not known. Our aim was to determine whether use of a tablet-based DST or team size altered adherence to the NRP algorithm in teams of healthcare providers (HCPs) performing simulated neonatal resuscitation.
METHOD


One hundred nine HCPs were randomized into a team of 2 or 3 and into using a DST or memory alone while performing 2 simulation scenarios. The primary outcome was NRP compliance, assessed by the modified Neonatal Resuscitation Performance Evaluation (NRPE). Secondary outcomes were the subcomponents of the NRPE score, cumulative time error (the cumulative time in seconds to perform resuscitation tasks in error, early or late, from NRP guidelines), and the interaction between DST and team size.
RESULTS


Decision support tool use improved total NRPE score when compared with memory alone (p = 0.015). There was no difference in NRPE score within teams of 2 compared with 3 HCPs. Cumulative time error was decreased with DST use compared with memory alone but was not significant (p = 0.057). Team size did not affect time error.
CONCLUSIONS


Teams with the DST had improved NRP adherence compared with teams relying on memory alone in 1 of 2 scenarios. Two and 3 HCP teams performed similarly. Given the positive results observed in the simulated environment, further testing the DST in the clinical environment is warranted.",2020,"RESULTS


Decision support tool use improved total NRPE score when compared with memory alone (p = 0.015).","['One hundred nine HCPs', 'Neonatal Resuscitation']","['DST or memory alone while performing 2 simulation scenarios', 'tablet-based DST', 'Decision support tools (DST']","['subcomponents of the NRPE score, cumulative time error (the cumulative time in seconds to perform resuscitation tasks in error, early or late, from NRP guidelines), and the interaction between DST and team size', 'NRP adherence', 'NRP compliance, assessed by the modified Neonatal Resuscitation Performance Evaluation (NRPE', 'total NRPE score', 'NRPE score', 'Cumulative time error']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",109.0,0.0853073,"RESULTS


Decision support tool use improved total NRPE score when compared with memory alone (p = 0.015).","[{'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Roitsch', 'Affiliation': ""From the Section of Neonatology, Department of Pediatrics (C.M.R., K.E.P., J.L.H., N.C.S.), Baylor College of Medicine & Texas Children's Hospital, Houston, TX; and Center for Medical Simulation and Innovative Education (J.L.A.), Johns Hopkins All Children's Hospital, St. Petersburg, FL.""}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Patricia', 'Affiliation': ''}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Hagan', 'Affiliation': ''}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Arnold', 'Affiliation': ''}, {'ForeName': 'Nathan C', 'Initials': 'NC', 'LastName': 'Sundgren', 'Affiliation': ''}]",Simulation in healthcare : journal of the Society for Simulation in Healthcare,['10.1097/SIH.0000000000000422']
406,31335805,A 24-week pilot study of dual maintenance therapy with raltegravir and lamivudine.,"BACKGROUND


There is an increasing interest in two-drug regimens. We hypothesized that maintenance therapy with raltegravir and lamivudine would keep HIV-1 suppressed and be well tolerated.
METHODS


Virally suppressed HIV-1-infected adults without previous viral failures or known resistance mutations to integrase inhibitors or 3TC/FTC or chronic hepatitis B were randomized 2 : 1 to switch to fixed-dose combination 150 mg lamivudine/300 mg raltegravir twice daily or to continue therapy. Primary outcome was the proportion of patients free of therapeutic failure (defined as viral failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death) at week 24. Secondary outcomes were changes in laboratory, body composition, sleep quality, adherence, and adverse effects.
RESULTS


There were 75 patients included: men 78%; median age 50 years; median CD4 622/μl. At week 24, 7 (9%) patients had therapeutic failure: raltegravir and lamivudine 2 (4%) vs. control 5 (20%). The difference in proportions of therapeutic failures raltegravir and lamivudine minus control was -0.159 (95% confidence interval: -0.353 to -0.012). There was a trend to more weight gain with raltegravir and lamivudine, but no significant changes in other secondary outcomes. Sixty-four percent of patients in each arm had at least one adverse effect. Two (6%) patients in control arm and 4 (7%) patients in raltegravir and lamivudine arm had severe adverse effects.
CONCLUSION


This pilot study suggests that switching to raltegravir along with lamivudine in patients with viral suppression maintains efficacy and is well tolerated. A larger study of longer duration is required to confirm these findings.",2019,The difference in proportions of therapeutic failures raltegravir plus lamivudine minus control was -0.159,"['75 patients included: men 78%; median age 50 years; median CD4\u200a622/mm', 'Virally suppressed HIV-1-infected adults without previous viral failures or known resistance mutations to integrase inhibitors or 3TC/FTC or chronic hepatitis B', 'patients with viral suppression']","['lamivudine', 'lamivudine/300\u200amg raltegravir twice daily or to continue therapy', 'raltegravir plus lamivudine']","['changes in laboratory, body composition, sleep quality, adherence, and adverse effects', 'proportion of patients free of therapeutic failure (defined as viral failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death', 'severe adverse effects', 'weight gain', 'tolerated', 'adverse effect', 'therapeutic failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0376601', 'cui_str': 'Integrase Inhibitors'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0524909', 'cui_str': 'Chronic Hepatitis B Virus Infection'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}]","[{'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",75.0,0.184609,The difference in proportions of therapeutic failures raltegravir plus lamivudine minus control was -0.159,"[{'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'de Lazzari', 'Affiliation': 'Infectious Diseases Unit, Hospital Clínic, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Lonca', 'Affiliation': ''}, {'ForeName': 'Jhon', 'Initials': 'J', 'LastName': 'Rojas', 'Affiliation': ''}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Gonzalez-Cordon', 'Affiliation': ''}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Blanch', 'Affiliation': ''}, {'ForeName': 'Alexy', 'Initials': 'A', 'LastName': 'Inciarte', 'Affiliation': ''}, {'ForeName': 'Amparo', 'Initials': 'A', 'LastName': 'Tricas', 'Affiliation': ''}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Rodriguez', 'Affiliation': ''}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Martinez-Rebollar', 'Affiliation': ''}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Laguno', 'Affiliation': ''}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Mallolas', 'Affiliation': ''}, {'ForeName': 'Sonsoles', 'Initials': 'S', 'LastName': 'Sanchez-Palomino', 'Affiliation': ''}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Plana', 'Affiliation': ''}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Blanco', 'Affiliation': ''}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Martinez', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000002311']
407,30944736,User Engagement Associated with Web-Intervention Features to Attain Clinically Meaningful Weight Loss and Weight Maintenance in Rural Women.,"Objective


Purely web-based weight loss and weight-loss maintenance interventions show promise to influence behavior change. Yet, little is known about user engagement with features of web-based interventions that predict clinically meaningful weight loss (≥5% bodyweight loss). This study examines level of website feature engagement with the likelihood of attaining ≥5% bodyweight loss after 6 and 18 months participation in a web-based intervention, among rural women at high risk of obesity-related diseases and disability.
Methods


In this secondary analysis of clinical trial data of 201 rural women, we examined weight change and user engagement, measured as clicks on specific web-based intervention features (messaging and self-tracking), as associated with clinically meaningful weight loss (baseline to 6 months) and weight-loss maintenance (6 to 18 months).
Results


Generalized estimating equations, adjusted for age, intervention group, and intervention phase, revealed high engagement with messaging predicted whether women achieved ≥5% weight loss at 6 months and at 18 months. There was no effect of self-tracking.
Conclusions


Being engaged with messages was associated with attaining clinically meaningful short-term and longer-term weight loss. This trial is registered with NCT01307644.",2019,"There was no effect of self-tracking.
","['Rural Women', 'rural women at high risk of obesity-related diseases and disability', '201 rural women, we examined weight change and user engagement, measured as clicks on specific web-based intervention features (messaging and self-tracking), as associated with clinically meaningful weight loss (baseline to 6\u2009months) and weight-loss maintenance (6 to 18\u2009months']",[],['weight loss'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]",[],"[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",201.0,0.0799965,"There was no effect of self-tracking.
","[{'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Hageman', 'Affiliation': 'Physical Therapy Education, College of Allied Health Professions, University of Nebraska Medical Center, 984420 Nebraska Medical Center, Omaha, NE 68198-4420, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Mroz', 'Affiliation': 'Physical Therapy Education, College of Allied Health Professions, University of Nebraska Medical Center, 984420 Nebraska Medical Center, Omaha, NE 68198-4420, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Yoerger', 'Affiliation': 'Physical Therapy Education, College of Allied Health Professions, University of Nebraska Medical Center, 984420 Nebraska Medical Center, Omaha, NE 68198-4420, USA.'}, {'ForeName': 'Carol H', 'Initials': 'CH', 'LastName': 'Pullen', 'Affiliation': 'College of Nursing, University of Nebraska Medical Center, 985330 Nebraska Medical Center, Omaha, NE 68198-5330, USA.'}]",Journal of obesity,['10.1155/2019/7932750']
408,32492084,Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19: A Randomized Clinical Trial.,"Importance


Convalescent plasma is a potential therapeutic option for patients with coronavirus disease 2019 (COVID-19), but further data from randomized clinical trials are needed.
Objective


To evaluate the efficacy and adverse effects of convalescent plasma therapy for patients with COVID-19.
Design, Setting, and Participants


Open-label, multicenter, randomized clinical trial performed in 7 medical centers in Wuhan, China, from February 14, 2020, to April 1, 2020, with final follow-up April 28, 2020. The trial included 103 participants with laboratory-confirmed COVID-19 that was severe (respiratory distress and/or hypoxemia) or life-threatening (shock, organ failure, or requiring mechanical ventilation). The trial was terminated early after 103 of a planned 200 patients were enrolled.
Intervention


Convalescent plasma in addition to standard treatment (n = 52) vs standard treatment alone (control) (n = 51), stratified by disease severity.
Main Outcomes and Measures


Primary outcome was time to clinical improvement within 28 days, defined as patient discharged alive or reduction of 2 points on a 6-point disease severity scale (ranging from 1 [discharge] to 6 [death]). Secondary outcomes included 28-day mortality, time to discharge, and the rate of viral polymerase chain reaction (PCR) results turned from positive at baseline to negative at up to 72 hours.
Results


Of 103 patients who were randomized (median age, 70 years; 60 [58.3%] male), 101 (98.1%) completed the trial. Clinical improvement occurred within 28 days in 51.9% (27/52) of the convalescent plasma group vs 43.1% (22/51) in the control group (difference, 8.8% [95% CI, -10.4% to 28.0%]; hazard ratio [HR], 1.40 [95% CI, 0.79-2.49]; P = .26). Among those with severe disease, the primary outcome occurred in 91.3% (21/23) of the convalescent plasma group vs 68.2% (15/22) of the control group (HR, 2.15 [95% CI, 1.07-4.32]; P = .03); among those with life-threatening disease the primary outcome occurred in 20.7% (6/29) of the convalescent plasma group vs 24.1% (7/29) of the control group (HR, 0.88 [95% CI, 0.30-2.63]; P = .83) (P for interaction = .17). There was no significant difference in 28-day mortality (15.7% vs 24.0%; OR, 0.65 [95% CI, 0.29-1.46]; P = .30) or time from randomization to discharge (51.0% vs 36.0% discharged by day 28; HR, 1.61 [95% CI, 0.88-2.93]; P = .12). Convalescent plasma treatment was associated with a negative conversion rate of viral PCR at 72 hours in 87.2% of the convalescent plasma group vs 37.5% of the control group (OR, 11.39 [95% CI, 3.91-33.18]; P < .001). Two patients in the convalescent plasma group experienced adverse events within hours after transfusion that improved with supportive care.
Conclusion and Relevance


Among patients with severe or life-threatening COVID-19, convalescent plasma therapy added to standard treatment, compared with standard treatment alone, did not result in a statistically significant improvement in time to clinical improvement within 28 days. Interpretation is limited by early termination of the trial, which may have been underpowered to detect a clinically important difference.
Trial Registration


Chinese Clinical Trial Registry: ChiCTR2000029757.",2020,"Clinical improvement occurred within 28 days in 51.9% (27/52) of the convalescent plasma group vs 43.1% (22/51) in the control group (difference, 8.8% [95% CI, -10.4% to 28.0%]; hazard ratio [HR], 1.40 [95% CI, 0.79-2.49]; P = .26).","['patients with COVID-19', 'patients with coronavirus disease 2019 (COVID-19', '60 [58.3%] male), 101 (98.1%) completed the trial', '103 of a planned 200 patients were enrolled', '103 patients who were randomized (median age, 70 years', 'Patients With Severe and Life-threatening COVID-19', '103 participants with laboratory-confirmed COVID-19 that was severe (respiratory distress and/or hypoxemia) or life-threatening (shock, organ failure, or requiring mechanical ventilation', '7 medical centers in Wuhan, China, from February 14, 2020, to April 1, 2020, with final follow-up April 28, 2020']","['Convalescent Plasma Therapy', 'convalescent plasma therapy', 'Intervention\n\n\nConvalescent plasma in addition to standard treatment (n\u2009=\u200952) vs standard treatment alone (control']","['Clinical improvement', 'time to clinical improvement', '28-day mortality, time to discharge, and the rate of viral polymerase chain reaction (PCR', '28-day mortality', 'adverse events', 'efficacy and adverse effects', 'time to clinical improvement within 28 days, defined as patient discharged alive or reduction of 2 points on a 6-point disease severity scale', 'negative conversion rate of viral PCR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1299454', 'cui_str': 'Patient discharged alive'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}]",103.0,0.448056,"Clinical improvement occurred within 28 days in 51.9% (27/52) of the convalescent plasma group vs 43.1% (22/51) in the control group (difference, 8.8% [95% CI, -10.4% to 28.0%]; hazard ratio [HR], 1.40 [95% CI, 0.79-2.49]; P = .26).","[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Guanggu District Maternal and Child Health Hospital of Hubei Province, Wuhan, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xunliang', 'Initials': 'X', 'LastName': 'Tong', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Beijing Hospital, National Respiratory quality control center, National Center of Gerontology, Beijing, China.'}, {'ForeName': 'Shangen', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Department of Transfusion, General Hospital of Central Theater Command of PLA, Wuhan, China.'}, {'ForeName': 'Juntao', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Medical Molecular Biology, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences & Peking Union, Beijing, China.'}, {'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Kong', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Ren', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens and Christophe Mérieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wei', 'Affiliation': 'Department of Blood Transfusion, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Mei', 'Affiliation': 'Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Caiying', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Wuhan Red Cross Hospital, Wuhan, China.'}, {'ForeName': 'Cuihua', 'Initials': 'C', 'LastName': 'Tao', 'Affiliation': 'Department of Blood Transfusion, Wuhan Asia Heart Hospital, Wuhan, China.'}, {'ForeName': 'Ru', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Wuhan Blood Center, Wuhan, China.'}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Yongpei', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Peking University Clinical Research Institute, Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Biomedical Engineering, School of Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Xiaoxiong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Emergency, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Zhihua', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Wuhan Red Cross Hospital, Wuhan, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': 'Guanggu District Maternal and Child Health Hospital of Hubei Province, Wuhan, China.'}, {'ForeName': 'Nian', 'Initials': 'N', 'LastName': 'Xiong', 'Affiliation': 'Wuhan Red Cross Hospital, Wuhan, China.'}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Wuhan Pulmonary Hospital, Wuhan, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Blood Transfusion, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Man', 'Affiliation': 'Department of Respiratory Medicine, Wuhan Asia General Hospital, Wuhan, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Deng', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Xuejun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Chenyue', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Conghui', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens and Christophe Mérieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shisheng', 'Initials': 'S', 'LastName': 'Su', 'Affiliation': 'Department of Biomedical Engineering, School of Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Linqi', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Center for Global Health and Infectious Diseases, Comprehensive AIDS Research Center, and Beijing Advanced Innovation Center for Structural Biology, School of Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens and Christophe Mérieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yanyun', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Pathology, University of Miami, Miami, Florida.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}]",JAMA,['10.1001/jama.2020.10044']
409,30628950,Comparison Between Continuous and Intermittent Administration of Hydrocortisone During Septic Shock: A Randomized Controlled Clinical Trial.,"OBJECTIVES


The best modality of administration of hydrocortisone during septic shock has been poorly evaluated and the guidelines remain unclear in this respect. This study aimed to compare bolus of hydrocortisone to a continuous infusion during septic shock.
DESIGN


Randomized controlled, open-label trial.
SETTING


Medical ICU of a university hospital.
PATIENTS


Adult patients with septic shock requiring more than 2 mg/h (approximately 33.3 μg/mn) of norepinephrine after adequate fluid administration were eligible.Patients already receiving corticosteroids or who have a contraindication to corticosteroids, patients who died within 24 h and those with a decision of not to resuscitate were excluded.
INTERVENTIONS


Patients were randomized either to receive hydrocortisone 200 mg/d by continuous infusion or by boluses of 50 mg every 6 h throughout the prescription of vasopressors with a maximum of 7 days.
RESULTS


Twenty-nine patients were included in each group. Shock reversal was significantly higher in the HC bolus group (66% vs. 35%, P = 0.008). The median time to shock reversal was 5 days (95% CI, 4.31-5.69) in the HC bolus group compared to 6 days (95% CI, 4.80-7.19) in the HC continuous infusion group (log Rank = 0.048). The number of hours spent with blood glucose ≥ 180 mg/dL was higher in the HC continuous infusion group with a median of 64 h [IQR (2-100)] versus 48 h [IQR (14-107)] in the HC bolus group, (P = 0.60), and daily insulin requirements were similar between the two groups (P = 0.63). The occurrence of other side effects, mortality, and ICU LOS were similar between the study groups.
CONCLUSION


Hydrocortisone administered by intermittent bolus was associated with higher shock reversal at day 7 compared with a continuous infusion.",2019,"dl was higher in the HC continuous infusion group with a median of 64 hours [IQR (2-100)] versus 48 hours [IQR (14-107)] in the HC bolus group, (p = 0.60), and daily insulin requirements were similar between the two groups, (p = 0.63).","['medical ICU of a university hospital', 'Patients already receiving corticosteroids or who have a contraindication to corticosteroids, patients who died within 24\u200ahours and those with a decision of not to resuscitate were excluded', 'adult patients with septic shock requiring more than 2\u200amg/h (approximately 33.3\u200aμg/mn) of norepinephrine after adequate fluid administration were eligible', 'Twenty nine patients were included in each group']","['hydrocortisone', 'hydrocortisone 200\u200amg/day by continuous infusion', 'Hydrocortisone']","['median time to shock reversal', 'shock reversal', 'Shock reversal', 'number of hours spent with blood glucose ≥', 'daily insulin requirements', 'occurrence of other side effects, mortality and ICU LOS']","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C2587207', 'cui_str': 'Resuscitate'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0439421', 'cui_str': 'mg/h'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C4517716', 'cui_str': 'Thirty-three point three'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]",29.0,0.46478,"dl was higher in the HC continuous infusion group with a median of 64 hours [IQR (2-100)] versus 48 hours [IQR (14-107)] in the HC bolus group, (p = 0.60), and daily insulin requirements were similar between the two groups, (p = 0.63).","[{'ForeName': 'Nejla', 'Initials': 'N', 'LastName': 'Tilouche', 'Affiliation': 'Intensive Care Unit, University Hospital Taher Sfar, Mahdia, Tunisia.'}, {'ForeName': 'Oussama', 'Initials': 'O', 'LastName': 'Jaoued', 'Affiliation': 'Intensive Care Unit, University Hospital Taher Sfar, Mahdia, Tunisia.'}, {'ForeName': 'Habiba Ben Sik', 'Initials': 'HBS', 'LastName': 'Ali', 'Affiliation': 'Intensive Care Unit, University Hospital Taher Sfar, Mahdia, Tunisia.'}, {'ForeName': 'Rim', 'Initials': 'R', 'LastName': 'Gharbi', 'Affiliation': 'Intensive Care Unit, University Hospital Taher Sfar, Mahdia, Tunisia.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Fekih Hassen', 'Affiliation': 'Intensive Care Unit, University Hospital Taher Sfar, Mahdia, Tunisia.'}, {'ForeName': 'Souheil', 'Initials': 'S', 'LastName': 'Elatrous', 'Affiliation': 'Intensive Care Unit, University Hospital Taher Sfar, Mahdia, Tunisia.'}]","Shock (Augusta, Ga.)",['10.1097/SHK.0000000000001316']
410,32180294,"Herbal formulation ""turmeric extract, black pepper, and ginger"" versus Naproxen for chronic knee osteoarthritis: A randomized, double-blind, controlled clinical trial.","Osteoarthritis is the most common articular disease that can lead to chronic pain and severe disability. Curcumin-an effective ingredient in turmeric with anti inflammatory property-plays an important role in protecting the joints against destructive factors. Gingerols and piperine, are the effective ingredients of ginger and black pepper, which may potentially enhance and sustain the effect of curcumin in this direction. To determine the effect of cosupplementation with turmeric extract, black pepper, and ginger on prostaglandin E 2  (PGE 2  ) in patients with chronic knee osteoarthritis, compared with Naproxen. Sixty patients with two different levels of knee osteoarthritis (Grade 2 and 3) were studied. Individuals were randomly assigned to receive daily turmeric extract, ginger, and black pepper together or Naproxen capsule for 4 weeks. PGE 2  was evaluated by ELISA method. 24-hr recall was also assessed. All of participants completed the study. PGE 2  decreased significantly in both groups (p < .001), but there was no significant differences between groups. The results of this study indicated that intake of the selected herbs twice a day for 4 weeks may improve the PGE 2  levels in patients with chronic knee osteoarthritis similar to Naproxen drug.",2020,"PGE 2  decreased significantly in both groups (p < .001), but there was no significant differences between groups.","['chronic knee osteoarthritis', 'Sixty patients with two different levels of knee osteoarthritis (Grade 2 and 3) were studied', 'patients with chronic knee osteoarthritis similar to Naproxen drug', 'patients with chronic knee osteoarthritis']","['Herbal formulation ""turmeric extract, black pepper, and ginger"" versus Naproxen', 'daily turmeric extract, ginger, and black pepper together or Naproxen capsule', 'Naproxen', 'cosupplementation with turmeric extract, black pepper, and ginger on prostaglandin E 2  (PGE 2  ']","['24-hr recall', 'PGE 2']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0027396', 'cui_str': 'Naproxen'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0376667', 'cui_str': 'Herbal'}, {'cui': 'C0077524', 'cui_str': 'Turmeric extract'}, {'cui': 'C0162750', 'cui_str': 'Black Pepper'}, {'cui': 'C1879327', 'cui_str': 'Zingiber officinale'}, {'cui': 'C0027396', 'cui_str': 'Naproxen'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0033559', 'cui_str': 'PGE'}, {'cui': 'C0763149', 'cui_str': 'PG(6)E'}]","[{'cui': 'C0763149', 'cui_str': 'PG(6)E'}]",60.0,0.254991,"PGE 2  decreased significantly in both groups (p < .001), but there was no significant differences between groups.","[{'ForeName': 'Motahar', 'Initials': 'M', 'LastName': 'Heidari-Beni', 'Affiliation': 'Department of Pediatrics, Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-communicable Disease, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Amir R', 'Initials': 'AR', 'LastName': 'Moravejolahkami', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Pegah', 'Initials': 'P', 'LastName': 'Gorgian', 'Affiliation': 'Food Security Research Center, Department of Community Nutrition, School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Askari', 'Affiliation': 'Food Security Research Center, Department of Community Nutrition, School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad J', 'Initials': 'MJ', 'LastName': 'Tarrahi', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Nimah', 'Initials': 'N', 'LastName': 'Bahreini-Esfahani', 'Affiliation': 'Food Security Research Center, Department of Community Nutrition, School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6671']
411,32170451,"Energy-dense, low-volume paediatric oral nutritional supplements improve total nutrient intake and increase growth in paediatric patients requiring nutritional support: results of a randomised controlled pilot trial.","Children with or at risk of faltering growth require nutritional support and are often prescribed oral nutritional supplements (ONS). This randomised controlled trial investigated the effects of energy-dense paediatric ONS (2.4 kcal/ml, 125 ml: cONS) versus 1.5 kcal/ml, 200 ml ONS (sONS) in community-based paediatric patients requiring oral nutritional support. Fifty-one patients (mean age 5.8 years (SD 3)) with faltering growth and/or requiring ONS to meet their nutritional requirements were randomised to cONS (n = 27) or sONS (n = 24) for 28 days. Nutrient intake, growth, ONS compliance and acceptability, appetite and gastro-intestinal tolerance were assessed. Use of the cONS resulted in significantly greater mean total daily energy (+ 531 kcal/day), protein (+ 10.1 g/day) and key micronutrient intakes compared with the sONS group at day 28 and over time, due to high ONS compliance (81% of patients ≥ 75%), maintained intake from diet alone and improved appetite in the cONS group, compared with the sONS group. Although growth increased in both intervention groups, results were significant in the cONS group (weight (p = 0.007), height (p < 0.001) and height z-score (p = 0.006)).Conclusions: This study shows that use of energy-dense (2.4 kcal/ml) low-volume paediatric-specific ONS leads to improved nutrient intakes, growth and appetite in paediatric patients requiring oral nutrition support compared with standard energy density ONS.Trial registration: The trial is registered at clinicaltrials.gov , identification number NCT02419599. What is Known: • Faltering growth is the failure of children to achieve adequate growth at a normal rate for their age and requires nutritional support, including the use of oral nutritional supplements (ONS). • Energy-dense, low-volume ONS have benefits over standard ONS in adults. What is New: • This is the first RCT to investigate the effects of energy-dense, low-volume ONS (2.4 kcal/ml, 125 ml) in children with faltering growth, showing significant improvements in total nutrient intake and increased growth. • Energy-dense, low-volume ONS can play a key role in the management of faltering growth.",2020,"Although growth increased in both intervention groups, results were significant in the cONS group (weight (p = 0.007), height (p < 0.001) and height z-score (p = 0.006)).Conclusions: This study shows that use of energy-dense (2.4 kcal/ml) low-volume paediatric-specific ONS leads to improved nutrient intakes, growth and appetite in paediatric patients requiring oral nutrition support compared with standard energy density ONS.Trial registration: The trial is registered at clinicaltrials.gov, identification number NCT02419599.What is Known:• Faltering growth is the failure of children to achieve adequate growth at a normal rate for their age and requires nutritional support, including the use of oral nutritional supplements (ONS).• Energy-dense, low-volume ONS have benefits over standard ONS in adults.","['paediatric patients requiring nutritional support', 'Fifty-one patients (mean age 5.8\xa0years (SD 3)) with faltering growth and/or requiring ONS to meet their nutritional requirements', 'Children with or at risk of faltering growth require nutritional support and are often prescribed oral nutritional supplements (ONS', 'community-based paediatric patients requiring oral nutritional support', 'paediatric patients requiring']","['oral nutrition support', 'cONS', '200\xa0ml ONS (sONS', 'sONS', 'energy-dense paediatric ONS']","['mean total daily energy', 'total nutrient intake', 'appetite', 'key micronutrient intakes', 'Nutrient intake, growth, ONS compliance and acceptability, appetite and gastro-intestinal tolerance', 'nutrient intakes, growth and appetite']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242739', 'cui_str': 'Nutritional Support'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0028719', 'cui_str': 'Nutrition Requirements'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0846669', 'cui_str': 'Oral nutritional support (regime/therapy)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0037683', 'cui_str': 'Sons'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}]",,0.0502259,"Although growth increased in both intervention groups, results were significant in the cONS group (weight (p = 0.007), height (p < 0.001) and height z-score (p = 0.006)).Conclusions: This study shows that use of energy-dense (2.4 kcal/ml) low-volume paediatric-specific ONS leads to improved nutrient intakes, growth and appetite in paediatric patients requiring oral nutrition support compared with standard energy density ONS.Trial registration: The trial is registered at clinicaltrials.gov, identification number NCT02419599.What is Known:• Faltering growth is the failure of children to achieve adequate growth at a normal rate for their age and requires nutritional support, including the use of oral nutritional supplements (ONS).• Energy-dense, low-volume ONS have benefits over standard ONS in adults.","[{'ForeName': 'Gary P', 'Initials': 'GP', 'LastName': 'Hubbard', 'Affiliation': 'Nutricia Ltd, Medical Affairs, Trowbridge, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Fry', 'Affiliation': 'Nutricia Ltd, Medical Affairs, Trowbridge, UK.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Sorensen', 'Affiliation': 'Nutricia Ltd, Medical Affairs, Trowbridge, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Casewell', 'Affiliation': ""Department of Nutrition and Dietetics, Ashford and St Peter's Hospitals NHS Foundation Trust, Chertsey, UK.""}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Collins', 'Affiliation': 'Department of Nutrition and Dietetics, Cumbria Partnership NHS Foundation Trust, Whitehaven, UK.'}, {'ForeName': 'Annaruby', 'Initials': 'A', 'LastName': 'Cunjamalay', 'Affiliation': 'Department of Nutrition and Dietetics, Hampshire Hospitals NHS Foundation Trust, Winchester, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Simpson', 'Affiliation': 'Department of Nutrition and Dietetics, Hampshire Hospitals NHS Foundation Trust, Winchester, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Wall', 'Affiliation': 'Department of Nutrition and Dietetics, East Lancashire Hospitals NHS Trust, Blackburn, UK.'}, {'ForeName': 'Elmarie', 'Initials': 'E', 'LastName': 'Van Wyk', 'Affiliation': 'Department of Nutrition and Dietetics, Great Western Hospitals NHS Foundation Trust, Swindon, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Ward', 'Affiliation': 'Department of Nutrition and Dietetics, Cwm Taf University Health Board, Prince Charles Hospital, Merthyr Tydfil, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Hallowes', 'Affiliation': ""Department of Nutrition and Dietetics, Guy's and St Thomas' NHS Trust, London, UK.""}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Duggan', 'Affiliation': ""Department of Nutrition and Dietetics, Guy's and St Thomas' NHS Trust, London, UK.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Robison', 'Affiliation': 'Department of Nutrition and Dietetics, Lewisham and Greenwich NHS Trust, London, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Gane', 'Affiliation': 'Department of Nutrition and Dietetics, Western Sussex Hospitals NHS Foundation Trust, Chichester, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Pope', 'Affiliation': 'Department of Nutrition and Dietetics, Western Sussex Hospitals NHS Foundation Trust, Chichester, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Clark', 'Affiliation': 'Department of Nutrition and Dietetics, Airedale NHS Foundation Trust, Keighley, UK.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Stratton', 'Affiliation': 'Nutricia Ltd, Medical Affairs, Trowbridge, UK. rjs@soton.ac.uk.'}]",European journal of pediatrics,['10.1007/s00431-020-03620-9']
412,32175985,Transversus abdominis plane block versus quadratus lumborum block type 2 for analgesia in renal transplantation: A randomised trial.,"BACKGROUND


Several studies have shown an analgesic efficacy of a transversus abdominis plane block (TAPB) in reducing opioid requirements during and after cadaveric renal transplantation surgery, but the effect of a quadratus lumborum block (QLB) in this type of surgery is unclear.
OBJECTIVES


The main objective of this prospective, randomised, double-centre clinical study was to compare the analgesic efficacy of a one-sided lateral approach TAPB with a unilateral QLB type 2 in cadaveric renal transplantation surgery.
DESIGN


Randomised, single-blinded trial.
SETTING


Two University-affiliated tertiary care hospitals between April 2016 and May 2017.
PATIENTS


A total of 101 patients aged more than 18 years, scheduled for cadaveric renal transplantation.
INTERVENTIONS


On receiving ethical board approval and individual informed consent, consecutive patients were allocated randomly to receive either an ultrasound-guided single-shot lateral TAPB or an ultrasound-guided single-shot QLB type 2 on the surgical side using 20 ml of bupivacaine 0.25% with adrenaline after a standardised induction of general anaesthesia. All patients on surgical completion and recovery from general anaesthesia were admitted to the postanaesthesia care unit for 24 h. They received standardised intravenous patient-controlled analgesia with fentanyl, and their pain scores were noted at regular intervals.
MAIN OUTCOME MEASURES


The primary endpoint was total cumulative fentanyl dose used per kg body mass in the first 24 h after surgery. Secondary outcomes were the need to start a continuous infusion of fentanyl in addition to patient-controlled analgesia boluses during the stay in post-anaesthesia care unit, postoperative pain severity measured using a numerical rating scale, patient satisfaction with analgesic treatment, evidence of postoperative nausea and vomiting, pruritus and sedation level.
RESULTS


The 49 patients allocated to the QLB type 2 group used significantly less fentanyl per kg in the first 24 h after surgery than the 52 patients who received a TAPB (median [IQR] 4.2 [2.3 to 8.0] μg kg versus 6.7 [3.5 to 10.7] μg kg, P = 0.042). No statistically significant differences were noted in the secondary endpoints within the study, including the frequency of adverse effects of opioids.
CONCLUSION


The reduction of fentanyl consumption in the first 24 h after renal transplantation with no difference in pain intensity and patient satisfaction shows a beneficial effect of one-sided QLB type 2 over a one-sided TAPB in regards to postoperative analgesia. However, the reduction in opioid consumption did not affect the frequency of opioid-related adverse effects.
TRIAL REGISTRATION


ClinicalTrials.gov ID: NCT02783586.",2020,The reduction of fentanyl consumption in the first 24 h after renal transplantation with no difference in pain intensity and patient satisfaction shows a beneficial effect of one-sided QLB type 2 over a one-sided TAPB in regards to postoperative analgesia.,"['All patients on surgical completion and recovery from general anaesthesia were admitted to the postanaesthesia care unit for 24\u200ah', 'renal transplantation', 'cadaveric renal transplantation surgery', 'Two University-affiliated tertiary care hospitals between April 2016 and May 2017', 'A total of 101 patients aged more than 18 years, scheduled for cadaveric renal transplantation']","['standardised intravenous patient-controlled analgesia with fentanyl', 'TAPB', 'transversus abdominis plane block (TAPB', 'ultrasound-guided single-shot lateral TAPB or an ultrasound-guided single-shot QLB type 2 on the surgical side using 20\u200aml of bupivacaine 0.25% with adrenaline', 'Transversus abdominis plane block versus quadratus lumborum block type 2 for analgesia']","['reduction of fentanyl consumption', 'need to start a continuous infusion of fentanyl in addition to patient-controlled analgesia boluses during the stay in post-anaesthesia care unit, postoperative pain severity measured using a numerical rating scale, patient satisfaction with analgesic treatment, evidence of postoperative nausea and vomiting, pruritus and sedation level', 'pain scores', 'analgesic efficacy', 'opioid consumption', 'frequency of adverse effects of opioids', 'total cumulative fentanyl dose used per kg body mass', 'pain intensity and patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care (regime/therapy)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0167914', 'cui_str': 'TAPB-H'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",101.0,0.286278,The reduction of fentanyl consumption in the first 24 h after renal transplantation with no difference in pain intensity and patient satisfaction shows a beneficial effect of one-sided QLB type 2 over a one-sided TAPB in regards to postoperative analgesia.,"[{'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Kolacz', 'Affiliation': 'From the I Department of Anesthesiology and Intensive Care, Medical University of Warsaw, Warsaw (MK, MJ, KZ, BB, JT) and Department of Anesthesiology and Intensive Care, Collegium Medicum, University of Warmia and Mazury in Olsztyn, Olsztyn, Poland (MM, MW-D, DO).'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Mieszkowski', 'Affiliation': ''}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Janiak', 'Affiliation': ''}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Zagorski', 'Affiliation': ''}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Byszewska', 'Affiliation': ''}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Weryk-Dysko', 'Affiliation': ''}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Onichimowski', 'Affiliation': ''}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Trzebicki', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001193']
413,30721652,Randomized Controlled Trial of a Prefeeding Oral Motor Therapy and Its Effect on Feeding Improvement in a Thai NICU.,"OBJECTIVE


To evaluate the effect of the Premature Infant Oral Motor Intervention (PIOMI) on preterm newborns' feeding efficiency and rates of improvement across Days 1, 3, and 5 of oral feeding in a Thai NICU.
DESIGN


Randomized controlled trial.
SETTING


A 20-bed special neonatal ward and 8-bed NICU in urban Thailand.
PARTICIPANTS


Stable newborns (N = 30) born between 26 and 34 weeks postmenstrual age (PMA) without comorbidities.
METHODS


After they reached 32 to 34 weeks PMA, participants were randomly assigned to groups. The experimental group (n = 15) received the PIOMI once daily for 7 consecutive days, and the control group (n = 15) received routine care only. After oral feedings were initiated, the mean volume (MV) of oral intake of two consecutive oral feedings was calculated on Days 1, 3, and 5 to assess feeding efficiency and compare the groups.
RESULTS


The MV of oral intake (percentage of prescribed feeding) was significantly greater in the experimental group versus the control group on all days of measurement. The MV consumed on Day 1 of oral feeding was 44.9% ± 7.33% in the experimental group versus 29.7% ± 9.55% in the control group (P < .001), 53.9% ± 8.01% versus 30.4% ± 11.07% on Day 3 (P < .001), and 61.7% ± 7.44% versus 34.8% ± 8.76 on Day 5 (P < .001). The rate of improvement was also accelerated in the intervention group.
CONCLUSION


The improved feeding efficiency that we found in our participants is consistent with results from other published studies and supports the use of the PIOMI as an effective oral motor therapy for newborns ages 32 to 34 weeks PMA.",2019,The MV of oral intake (percentage of prescribed feeding) was significantly greater in the experimental group versus the control group on all days of measurement.,"['newborns ages 32 to 34\xa0weeks PMA', 'A 20-bed special neonatal ward and 8-bed NICU in urban Thailand', 'preterm newborns', 'Stable newborns (N\xa0= 30) born between 26 and 34\xa0weeks postmenstrual age (PMA) without comorbidities', 'a Thai NICU']","['Prefeeding Oral Motor Therapy', 'routine care only', 'Premature Infant Oral Motor Intervention (PIOMI']","['mean volume (MV) of oral intake', 'rate of improvement', 'feeding efficiency', 'MV of oral intake (percentage of prescribed feeding']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0048451', 'cui_str': 'p-methoxy-alpha-methylphenethylamine'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0337910', 'cui_str': 'Thai'}]","[{'cui': 'C0589303', 'cui_str': 'Oral motor therapy (regime/therapy)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",,0.0439014,The MV of oral intake (percentage of prescribed feeding) was significantly greater in the experimental group versus the control group on all days of measurement.,"[{'ForeName': 'Brenda S', 'Initials': 'BS', 'LastName': 'Lessen Knoll', 'Affiliation': ''}, {'ForeName': 'Tipawan', 'Initials': 'T', 'LastName': 'Daramas', 'Affiliation': ''}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Drake', 'Affiliation': ''}]","Journal of obstetric, gynecologic, and neonatal nursing : JOGNN",['10.1016/j.jogn.2019.01.003']
414,30805213,Exercise Dose Effects on Body Fat 12 Months after an Exercise Intervention: Follow-up from a Randomized Controlled Trial.,"Background


Exercise interventions can result in weight loss, which is associated with reductions in disease risk. It is unknown how the volume of exercise prescribed in a one-time exercise intervention impacts long-term body fatness. We compared 24-month body fat changes among postmenopausal women previously prescribed 300 versus 150 minutes/week of exercise in a year-long exercise intervention trial.
Methods


The Breast Cancer and Exercise Trial in Alberta (BETA) was a two-centred randomized controlled trial in Alberta, Canada. The trial consisted of a 12-month intervention and 12-month observation period. For the intervention, participants were randomized to either a moderate-volume exercise group (150 min/week) or a high-volume exercise group (300 min/week). Participants in this study were 334 inactive postmenopausal women who had been followed-up to 24 months. The primary outcome for this study was 24-month change in total body fat using dual energy X-ray absorptiometry scans. Other measures included weight, waist and hip circumferences, subcutaneous and intra-abdominal fat from computed tomography scans, and lean mass. Researchers were blinded to randomization group when measuring body fat.
Results


Both groups self-reported ∼180 minutes/week moderate-vigorous activity at 24 months. No statistically significant difference was found in total body fat at 24 months between the two groups. Statistically significant effects (comparing high versus moderate groups) were found for BMI (least-square mean change (95% CI): -0.66 (-0.97, -0.36) versus -0.25 (-0.55, 0.05) kg/m 2 ,  P =0.04), waist-to-hip ratio (-0.033 (-0.040, -0.026) versus -0.023 (-0.030, -0.016),  P =0.05), and subcutaneous abdominal fat area (-32.18 (-39.30, -25.06) versus -22.20 (-29.34, -15.05) cm 2 ,  P =0.04).
Conclusion


Prescribing 300 versus 150 minutes/week of exercise to inactive postmenopausal women resulted in some long-term greater decreases in measures of body composition but no overall differences in total body fat loss. This trail is registered with NCT01435005.",2019,No statistically significant difference was found in total body fat at 24 months between the two groups.,"['postmenopausal women previously prescribed 300 versus 150 minutes/week of exercise in a year-long exercise intervention trial', 'Alberta', '334 inactive postmenopausal women who had been followed-up to 24 months']","['moderate-volume exercise group (150\u2009min/week) or a high-volume exercise', '\n\n\nExercise interventions']","['waist-to-hip ratio', 'BMI', 'weight loss', 'total body fat using dual energy X-ray absorptiometry scans', 'weight, waist and hip circumferences, subcutaneous and intra-abdominal fat from computed tomography scans, and lean mass', 'body composition', 'total body fat', 'subcutaneous abdominal fat area', 'total body fat loss']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0556975', 'cui_str': 'mins/week'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0556975', 'cui_str': 'mins/week'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0424677', 'cui_str': 'Total body fat (observable entity)'}, {'cui': 'C1959592', 'cui_str': 'DEXA Scan'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1563739', 'cui_str': 'Intra-Abdominal Fat'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0441633'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1563742', 'cui_str': 'Abdominal Fat'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",334.0,0.097214,No statistically significant difference was found in total body fat at 24 months between the two groups.,"[{'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Friedenreich', 'Affiliation': 'Department of Cancer Epidemiology and Prevention Research, CancerControl Alberta, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Yibing', 'Initials': 'Y', 'LastName': 'Ruan', 'Affiliation': 'Department of Cancer Epidemiology and Prevention Research, CancerControl Alberta, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Aalo', 'Initials': 'A', 'LastName': 'Duha', 'Affiliation': 'Cross Cancer Institute, CancerControl Alberta, Alberta Health Services, Edmonton, Alberta, Canada.'}, {'ForeName': 'Kerry S', 'Initials': 'KS', 'LastName': 'Courneya', 'Affiliation': 'Faculty of Physical Education and Recreation, University of Alberta, Edmonton, Alberta, Canada.'}]",Journal of obesity,['10.1155/2019/3916416']
415,32066197,"A Comparison of Matching and Weighting Methods for Causal Inference Based on Routine Health Insurance Data, or: What to do If an RCT is Impossible.","Due to a multitude of reasons Randomized Control Trials on the basis of so-called ""routine data"" provided by insurance companies cannot be conducted. Therefore the estimation of ""causal effects"" for any kind of treatment is hampered since systematic bias due to specific selection processes must be suspected. The basic problem of counterfactual, which is to evaluate the difference between two potential outcomes for the same unit, is discussed. The focus lies on the comparison of the performance of different approaches to control for systematic differences between treatment and control group. These strategies are all based on propensity scores, namely matching or pruning, IPTW (inverse probability treatment weighting) and entropy balancing. Methods to evaluate these strategies are presented. A logit model is employed with 87 predictors to estimate the propensity score or to estimate the entropy balancing weights. All analyses are restricted to estimate the ATT (Average Treatment Effect for the Treated) Exemplary data come from a prospective controlled intervention-study with two measurement occasions. Data contain 35 857 chronically ill insurants with diabetes, congestive heart failure, arteriosclerosis, coronary heart disease or hypertension of one German sickness fund. The intervention group was offered an individual telephone coaching to improve health behavior and slow down disease progression while the control group received treatment as usual. Randomization took place before the insurants' consent to participate was obtained so assumptions of an RCT are violated. A weighted mixture model (difference-in-difference) as the causal model of interest is employed to estimate treatment effects in terms of costs distinguishing the categories outpatient costs, medication costs, and total costs. It is shown that entropy balancing performs best with respect to balancing treatment and control group at baseline for the first three moments of all 87 predictors. This will result in least biased estimates of the treatment effect.",2020,It is shown that entropy balancing performs best with respect to balancing treatment and control group at baseline for the first three moments of all 87 predictors.,"['857 chronically ill insurants with diabetes, congestive heart failure, arteriosclerosis, coronary heart disease or hypertension of one German sickness fund']",['individual telephone coaching'],['health behavior and slow down disease progression'],"[{'cui': 'C0008715', 'cui_str': 'Chronically Ill'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C0003850', 'cui_str': 'Arteriosclerosis'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0016820', 'cui_str': 'Funds'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0018687'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}]",35857.0,0.0388999,It is shown that entropy balancing performs best with respect to balancing treatment and control group at baseline for the first three moments of all 87 predictors.,"[{'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Matschinger', 'Affiliation': ''}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Heider', 'Affiliation': ''}, {'ForeName': 'Hans-Helmut', 'Initials': 'HH', 'LastName': 'König', 'Affiliation': ''}]",Gesundheitswesen (Bundesverband der Arzte des Offentlichen Gesundheitsdienstes (Germany)),['10.1055/a-1009-6634']
416,32175349,The role of preoperative 3D-ultrasound in intraoperative judgement for hysteroscopic adhesiolysis.,"Background


Hysteroscopic adhesiolysis (HA) remains the mainstay of treatment for intrauterine adhesions (IUA). In cases of moderate or severe IUA, the assistance of various adjunctive aids are usually sought to improve HA's success rate. Among these, intraoperative transabdominal ultrasound (TAS) is the most common; however, it has certain limitations. Preoperative three-dimensional transvaginal ultrasound (3D-TVUS) has been accepted as a non-invasive way to provide accurate information about the uterine cavity. This prospective, non-randomized controlled study will assess the effects of pre-operative 3D-TVUS prior to HA in improving the surgeon's intraoperative judgement.
Methods


A total of 362 patients, who met the inclusion criteria, aged between 18 and 45 years and diagnosed with moderate or severe IUA underwent HA at our hospital from March 2018 to December 2018. Participants were divided into 2 groups; the study group; n=182 performed 3D-TVUS evaluation prior to HA, and the control group; n=180 underwent HA without preoperative 3D-TVUS evaluation. The following basic information were collected prospectively for both groups: age, parity, history of abortion, degree of IUA, surgical complications and number of hysteroscopic interventions. The data obtained from 3D-TVUS in the study group was carefully studied at the preoperative stage by the operator and was integrated into intraoperative findings, further assisting with intraoperative decisions. The guiding value of preoperative 3D-TVUS for HA was evaluated by comparing and analyzing the postoperative exposure rate of clearly visible tubal ostia between the groups.
Results


Based on the basic information (P>0.05) collected preoperatively, there were no statistically significant differences between the groups. Postoperatively, the study group had a better surgical success rate with a more significant AFS score reduction (4.71±2.05; P<0.0001) and better morphological restoration of the uterine cavity, with more adhesion-free uterine horns and more clearly visible fallopian tube ostia (P<0.0001) following HA.
Conclusions


This study showed that preoperative 3D-TVUS evaluation helped the hysteroscopists with their intraoperative decision-making while carrying out HA. In comparison to those who did not perform preoperative 3D ultrasound, those who underwent 3D-TVUS evaluation had a better surgical success rate in retrieving the fallopian tube ostia and the restoration of normal uterine cavity morphology.",2020,"Postoperatively, the study group had a better surgical success rate with a more significant AFS score reduction (4.71±2.05; P<0.0001) and better morphological restoration of the uterine cavity, with more adhesion-free uterine horns and more clearly visible fallopian tube ostia (P<0.0001) following HA.
","['362 patients, who met the inclusion criteria, aged between 18 and 45 years and diagnosed with moderate or severe IUA underwent HA at our hospital from March 2018 to December 2018']","['pre-operative 3D-TVUS prior to HA', '3D-TVUS evaluation prior to HA, and the control group; n=180 underwent HA without preoperative 3D-TVUS evaluation', 'preoperative 3D-ultrasound', '\n\n\nHysteroscopic adhesiolysis (HA', 'Preoperative three-dimensional transvaginal ultrasound (3D-TVUS', 'intraoperative transabdominal ultrasound (TAS']","['AFS score reduction', 'morphological restoration of the uterine cavity, with more adhesion-free uterine horns and more clearly visible fallopian tube ostia', 'surgical success rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0012826', 'cui_str': 'Lysis of adhesions (procedure)'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0205496', 'cui_str': 'Abdominal approach (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0227844', 'cui_str': 'Endometrial cavity structure'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0019939', 'cui_str': 'Horns'}, {'cui': 'C0205379', 'cui_str': 'Visible (qualifier value)'}, {'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",362.0,0.035536,"Postoperatively, the study group had a better surgical success rate with a more significant AFS score reduction (4.71±2.05; P<0.0001) and better morphological restoration of the uterine cavity, with more adhesion-free uterine horns and more clearly visible fallopian tube ostia (P<0.0001) following HA.
","[{'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Burjoo', 'Affiliation': 'Department of Obstetrics and Gynecology, Third Xiangya Hospital of Central South University, Changsha 410013, China.'}, {'ForeName': 'Xingping', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Obstetrics and Gynecology, Third Xiangya Hospital of Central South University, Changsha 410013, China.'}, {'ForeName': 'Lingxiao', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': 'Department of Obstetrics and Gynecology, Third Xiangya Hospital of Central South University, Changsha 410013, China.'}, {'ForeName': 'Xinyi', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Obstetrics and Gynecology, Third Xiangya Hospital of Central South University, Changsha 410013, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Lei', 'Affiliation': 'Department of Obstetrics and Gynecology, Third Xiangya Hospital of Central South University, Changsha 410013, China.'}, {'ForeName': 'Baiyun', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Ultrasound, Hunan Guangxiu Hospital, Changsha 410013, China.'}, {'ForeName': 'Dabao', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Department of Obstetrics and Gynecology, Third Xiangya Hospital of Central South University, Changsha 410013, China.'}]",Annals of translational medicine,['10.21037/atm.2020.01.06']
417,32171731,Methods for Dissecting Intersegmental Planes in Segmentectomy: A Randomized Controlled Trial.,"BACKGROUND


The perioperative outcomes of the use of stapling devices versus electrocautery to dissect intersegmental planes in patients undergoing segmentectomy for small pulmonary lesions is still unclear. The aim of this randomized controlled trial was to compare the perioperative outcomes of these two methods.
METHODS


A single-center, prospective, participant-blinded, randomized controlled trial (NCT03192904) was conducted with a preplanned sample size of 136. The primary outcome was the incidence of postoperative complications. Secondary outcomes included duration of operation, blood loss during operation, first-day drainage volume, duration of drainage, postoperative hospital stay, loss of lung function, and medical costs.
RESULTS


The trial was stopped early as a result of a marked difference in the primary outcome between groups at a scheduled interim check of the data after recruiting 70 patients. The incidence of postoperative complications (eg, air leakage) was higher in the electrocautery group than in the stapler device group (11/32, 34.4% vs 2/33, 6.1%, P = .004). There were no differences in duration of operation, blood loss during operation, first-day drainage volume, duration of drainage, postoperative hospital stays, loss of lung function, or total medical cost, although the per-patient cost of medical materials was higher in the stapler device group (US$4214.6 ± 1185.4 vs $3260.1 ± 852.6, P < .001).
CONCLUSIONS


Among patients undergoing segmentectomy, the use of stapler devices to divide intersegmental planes decreased postoperative complications without further compromising lung function or increasing economic burden.",2020,"The incidence of postoperative complications (e.g., air leakage etc.) was higher in the electrocautery group than in the stapler device group (11/32, 34.4% vs. 2/33, 6.1%, p = 0.004).","['Segmentectomy', 'patients undergoing segmentectomy', 'patients undergoing segmentectomy for small pulmonary lesions']",['stapling devices versus electrocautery'],"['postoperative complications', 'surgery duration, blood loss during surgery, first day drainage volume, duration of drainage, postoperative hospital stays, loss of lung function, or total medical cost, although the per-patient cost of medical materials', 'incidence of postoperative complications', 'duration of surgery, blood loss during surgery, first day drainage volume, duration of drainage, postoperative hospital stay, loss of lung function and medical costs', 'incidence of postoperative complications (e.g., air leakage etc']","[{'cui': 'C0024885', 'cui_str': 'Local Excision Mastectomy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0013804', 'cui_str': 'Surgical Diathermy'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0333257', 'cui_str': 'Air leakage (morphologic abnormality)'}]",70.0,0.196245,"The incidence of postoperative complications (e.g., air leakage etc.) was higher in the electrocautery group than in the stapler device group (11/32, 34.4% vs. 2/33, 6.1%, p = 0.004).","[{'ForeName': 'Xingshi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Runsen', 'Initials': 'R', 'LastName': 'Jin', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xiang', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Dingpei', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Yajie', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Chengqiang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Hailei', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Junbiao', 'Initials': 'J', 'LastName': 'Hang', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Alan D L', 'Initials': 'ADL', 'LastName': 'Sihoe', 'Affiliation': 'Department of Surgery, The University of Hong Kong, Hong Kong; The University of Hong Kong Shenzhen Hospital, Shenzhen; Department of Thoracic Surgery, Tongji University, Shanghai Pulmonary Hospital, Shanghai, China.'}, {'ForeName': 'Hecheng', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai. Electronic address: lihecheng2000@hotmail.com.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2020.02.013']
418,30863632,"Double-Blind, Randomized, Three-Armed, Placebo-Controlled, Clinical Investigation to Evaluate the Benefit and Tolerability of Two Dosages of IQP-AE-103 in Reducing Body Weight in Overweight and Moderately Obese Subjects.","Objective


This study was performed to determine the efficacy and tolerability/safety of IQP-AE-103 on body weight reduction in overweight to moderately obese adults.
Methods


A double-blind, randomized, placebo-controlled trial involved one hundred and eight subjects (BMI between 25 and 35 kg/m 2 ) that were randomly assigned to either the low-dose or the high-dose IQP-AE-103 group, or the placebo group. Following a 2-week run-in period, subjects received two capsules of investigational product after three daily main meals for 12 weeks. Subjects were instructed to maintain a nutritionally balanced hypocaloric diet according to the individual's energy requirement. Body weight, body fat, and waist and hip circumference were measured at baseline, and after 2, 4, 8, and 12 weeks. Subjects also rated their feelings of hunger and fullness using visual analogue scales, and food craving on a 5-point scale at the same time intervals. Blood samplings for safety laboratory parameters were taken before and at the end of the study.
Results


After 12 weeks of intake, the high-dose IQP-AE-103 group had a significantly greater weight loss compared with the placebo (5.03 ± 2.50 kg vs. 0.98 ± 2.06 kg, respectively;  p  < 0.001) and the low-dose group (3.01 ± 2.19 kg;  p =0.001). The high-dose group experienced a decrease in body fat of 3.15 ± 2.41 kg compared with a decrease of 0.23 ± 2.74 kg for the placebo group ( p  < 0.001). High-dose IQP-AE-103 also decreased the feeling of hunger in 66% subjects. A beneficial effect of IQP-AE-103 on the lipid metabolism was also demonstrated in the subgroup of subjects with baseline total cholesterol levels above 6.2 mmol/L. No side effects related to the intake of IQP-AE-103 were reported.
Conclusions


These findings indicate that IQP-AE-103 could be an effective and safe weight loss intervention. This trial is registered with NCT03058367.",2019,The high-dose group experienced a decrease in body fat of 3.15 ± 2.41 kg compared with a decrease of 0.23 ± 2.74 kg for the placebo group ( p  < 0.001).,"['one hundred and eight subjects (BMI between 25 and 35\u2009kg/m 2 ', 'overweight to moderately obese adults', 'subgroup of subjects with baseline total cholesterol levels above 6.2\u2009mmol/L', 'Overweight and Moderately Obese Subjects']","['Placebo', 'placebo', 'IQP-AE-103']","['feelings of hunger and fullness using visual analogue scales, and food craving on a 5-point scale', 'Body Weight', 'weight loss', 'effective and safe weight loss intervention', 'efficacy and tolerability/safety', 'feeling of hunger', 'lipid metabolism', 'body weight reduction', 'body fat', 'Body weight, body fat, and waist and hip circumference']","[{'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0222045'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}]",108.0,0.274677,The high-dose group experienced a decrease in body fat of 3.15 ± 2.41 kg compared with a decrease of 0.23 ± 2.74 kg for the placebo group ( p  < 0.001).,"[{'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Uebelhack', 'Affiliation': 'analyze & realize GmbH, Weißenseer Weg 111, 10369 Berlin, Germany.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Bongartz', 'Affiliation': 'analyze & realize GmbH, Weißenseer Weg 111, 10369 Berlin, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Seibt', 'Affiliation': 'analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany.'}, {'ForeName': 'Gordana', 'Initials': 'G', 'LastName': 'Bothe', 'Affiliation': 'analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany.'}, {'ForeName': 'Pee Win', 'Initials': 'PW', 'LastName': 'Chong', 'Affiliation': 'Zaluvida Corporate Sdn Bhd, E-16 Plaza Mont Kiara, 2 Jalan Kiara, 50480 Kuala Lumpur, Malaysia.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'De Costa', 'Affiliation': 'InQpharm Group Sdn Bhd, E-16 Plaza Mont Kiara, 2 Jalan Kiara, 50480 Kuala Lumpur, Malaysia.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Wszelaki', 'Affiliation': 'Zaluvida Corporate Sdn Bhd, E-16 Plaza Mont Kiara, 2 Jalan Kiara, 50480 Kuala Lumpur, Malaysia.'}]",Journal of obesity,['10.1155/2019/3412952']
419,32057924,Preliminary findings on the role of high-frequency (5Hz) rTMS stimulation on M1 and pre-SMA regions in Parkinson's disease.,"It has been already shown that the motor symptoms of the Parkinson's Disease (PD) have been improved with high frequency rTMS although there is no consensus on the most suitable target brain localization for a maximal therapeutic efficacy. Here, we aimed to compare the therapeutic effect of high frequency (5Hz) rTMS stimulation on primary motor cortex (M1) and pre-supplementary (pre SMA) regions in patients with PD who were still on pharmacological treatment. The study included right-hand dominant16 patients with PD (5 females, 11 males) with demographically and clinically similar characteristics which were randomly assigned to group 1 (n=8) and group 2 (n=8) and received left M1 and the left pre-SMA rTMS procedure, respectively. Total and sequential motor scores of the Unified Parkinson's Disease Rating Scale (UPDRSmotor) were applied to all patients at the baseline and the patients were re-evaluated under the same clinical conditions one week after the end of the sessions. Comparisons of the UPDRS-motor scores between two groups yielded significant improvements after the rTMS on pre-SMA compared to M1 (M1 p=0.14; pre-SMA p=0.01). which were especially significant for the bradykinesia (p=0.04) and axial score related items (p=0.01). This is the first study that shows the effect of rTMS on pre-SMA and it appears to be a promising option in the treatment of PD.",2020,Comparisons of the UPDRS-motor scores between two groups yielded significant improvements after the rTMS on pre-SMA compared to M1 (M1 p=0.14; pre-SMA p=0.01). which were especially significant for the bradykinesia (p=0.04) and axial score related items (p=0.01).,"['right-hand dominant16 patients with PD (5 females, 11 males) with demographically and clinically similar characteristics', 'patients with PD who were still on pharmacological treatment']","['rTMS', 'left M1 and the left pre-SMA rTMS procedure', 'high frequency (5Hz) rTMS stimulation']","['UPDRS-motor scores', ""Total and sequential motor scores of the Unified Parkinson's Disease Rating Scale (UPDRSmotor"", 'primary motor cortex (M1) and pre-supplementary (pre SMA) regions', 'bradykinesia']","[{'cui': 'C0344333', 'cui_str': 'Right handed (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0222045'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0233565', 'cui_str': 'Bradykinesia'}]",,0.0160364,Comparisons of the UPDRS-motor scores between two groups yielded significant improvements after the rTMS on pre-SMA compared to M1 (M1 p=0.14; pre-SMA p=0.01). which were especially significant for the bradykinesia (p=0.04) and axial score related items (p=0.01).,"[{'ForeName': 'Lütfü', 'Initials': 'L', 'LastName': 'Hanoğlu', 'Affiliation': 'Istanbul Medipol University, Turkey.'}, {'ForeName': 'Mevhibe', 'Initials': 'M', 'LastName': 'Saricaoglu', 'Affiliation': 'Istanbul Medipol University, Turkey. Electronic address: mevhibe-saricaoglu@hotmail.com.'}, {'ForeName': 'Güven', 'Initials': 'G', 'LastName': 'Toprak', 'Affiliation': 'Istanbul Medipol University, Turkey.'}, {'ForeName': 'Nesrin Helvacı', 'Initials': 'NH', 'LastName': 'Yılmaz', 'Affiliation': 'Istanbul Medipol University, Turkey.'}, {'ForeName': 'Burak', 'Initials': 'B', 'LastName': 'Yuluğ', 'Affiliation': 'Istanbul Medipol University, Turkey; Alanya Alaaddin Keykubat University Department of Neurology, Alanya, Antalya, Turkey.'}]",Neuroscience letters,['10.1016/j.neulet.2020.134837']
420,32189654,"Immunization coverage among under-five children living along a school student through child-to-child and child-to-parent information, education and communication strategy.","Background


In spite of being a principal producer and exporter of vaccines and billions spent over decades, India is home to one-third of the world's under-five children (U5C) with no immunization.
Objectives


The objective of this study was to find the outcome of child-to-child and child-to-parent Information, Education and Communication (IEC) strategy on the current percentage of immunization coverage (IC).
Methods


A mixed design research with multilevel concurrent sampling was conducted in Pune. Based on school students' households, 44 clusters having U5C were divided randomly into 11 experimental/control groups each. IEC strategy to students was independent variable and IC among U5C was dependent variable. Data were collected from 1092 students and 2352 U5C parents over 6 years. Vaccination card and Bacillus Calmette-Guérin mark were considered as evidence to conclude on full, partial and no IC. Change in knowledge quotient (KQ) among students/parents and U5C IC before and after IEC strategy assessed.
Results


Rural/urban age-appropriate full IC of U5C was 51% and 67% before and 88% and 85% in post-IEC, respectively. The mean KQ change score of 8-12/20 in students is likely to increase full IC by 37% and 18%, decrease partial coverage at 14% and 12%, and improve none coverage at 23% and 16%, from its existing level positively in experimental groups. Numerous factors discouraged parents to pursue their U5C immunization.
Conclusions


Advocacy through school students can be an economically viable alternative marketing strategy for inadequate U5C IC than billions spent on treating vaccine-preventable diseases and impractical options.",2019,"Conclusions


Advocacy through school students can be an economically viable alternative marketing strategy for inadequate U5C IC than billions spent on treating vaccine-preventable diseases and impractical options.","[""school students' households, 44 clusters having U5C"", '1092 students and 2352 U5C parents over 6 years']",[],"['knowledge quotient (KQ', 'mean KQ change score', 'partial coverage']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}]",,0.0295003,"Conclusions


Advocacy through school students can be an economically viable alternative marketing strategy for inadequate U5C IC than billions spent on treating vaccine-preventable diseases and impractical options.","[{'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Vaidyanathan', 'Affiliation': 'Professor and Principal, Pravara Institute of Medical Sciences (DU), CON, Ahmednagar, Maharashtra, India.'}]",Indian journal of public health,['10.4103/ijph.IJPH_424_18']
421,31895002,"Efficacy and Safety of Mirabegron versus Placebo Add-On Therapy in Men with Overactive Bladder Symptoms Receiving Tamsulosin for Underlying Benign Prostatic Hyperplasia: A Randomized, Phase 4 Study (PLUS).","PURPOSE


PLUS investigated the efficacy and safety of mirabegron add-on therapy in men with overactive bladder symptoms receiving tamsulosin for underlying lower urinary tract symptoms attributable to benign prostatic hyperplasia.
MATERIALS AND METHODS


In this phase 4 study a 4-week 0.4 mg tamsulosin run-in period was followed by a 12-week, randomized, double-blind, treatment period in which patients initially received 25 mg mirabegron or placebo add-on therapy. At 4 weeks doses were titrated to 50 mg mirabegron or placebo equivalent. Efficacy end points were changes from baseline to end of treatment in mean number of micturitions per day (primary), mean volume voided per micturition, number of urgency episodes per day, total urgency and frequency score, and total International Prostate Symptom Score (secondary). Safety assessments included treatment emergent adverse events, and post-void residual volume, and maximum urinary flow measurements.
RESULTS


Of the 676 men most were 65 years old or older (380, 56.2%). Tamsulosin plus mirabegron was statistically superior to tamsulosin plus placebo in reducing the mean number of micturitions per day (-2.00 vs -1.62; adjusted difference -0.39; 95% CI -0.76, -0.02). Statistically superior results were noted for tamsulosin plus mirabegron in mean volume voided per micturition, urgency episodes per day, and total urgency and frequency score (not International Prostate Symptom Score). Higher overall treatment emergent adverse event rates were observed with tamsulosin plus placebo, although higher rates of drug related treatment emergent adverse events were noted with tamsulosin plus mirabegron. Urinary retention rates were higher in the tamsulosin plus mirabegron group. Post-void residual volume and maximum urinary flow results were not clinically meaningful.
CONCLUSIONS


The results of PLUS underscore the utility of mirabegron add-on therapy to treat men with overactive bladder symptoms receiving tamsulosin for benign prostatic hyperplasia.",2020,"Statistically superior results were noted for TAM+MIRA in MVV/micturition, urgency episodes/day, and TUFS (not IPSS).","['Of 676 men, most were ≥65 years old (380 [56.2%] patients', 'men with OAB symptoms receiving', 'men with overactive bladder (OAB) symptoms receiving tamsulosin for underlying lower urinary tract symptoms attributable to benign prostatic hyperplasia (BPH', 'Men with Overactive Bladder Symptoms Receiving Tamsulosin for Underlying Benign Prostatic Hyperplasia']","['tamsulosin', 'TAM+PL', 'TAM+MIRA', 'mirabegron 25 mg or placebo', 'tamsulosin plus placebo (TAM+PL', 'mirabegron 50 mg or placebo', 'Tamsulosin plus mirabegron (TAM+MIRA', 'Mirabegron versus Placebo']","['TAM+MIRA in MVV/micturition, urgency episodes/day, and TUFS (not IPSS', 'mean number of micturitions/day (primary), mean volume voided (MVV)/micturition, number of urgency episodes/day, Total Urgency and Frequency Score (TUFS), and total International Prostate Symptom Score (IPSS; secondary', 'efficacy and safety', 'PVR volume and Q max', 'Higher overall TEAE rates', 'Efficacy and Safety', 'Urinary retention rates', 'post-void residual (PVR) volume and maximum urinary flow (Q max ) assessments']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4319693', 'cui_str': 'Three hundred and eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}, {'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C0005001', 'cui_str': 'Benign enlargement of prostate'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C3474323', 'cui_str': 'mirabegron 25 MG'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3474335', 'cui_str': 'mirabegron 50 MG'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}]","[{'cui': 'C0024967', 'cui_str': 'MVV (Ventilation)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1997470', 'cui_str': 'Total international prostate symptom score'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0080274', 'cui_str': 'Urinary Retention'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume (observable entity)'}, {'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",676.0,0.178298,"Statistically superior results were noted for TAM+MIRA in MVV/micturition, urgency episodes/day, and TUFS (not IPSS).","[{'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Kaplan', 'Affiliation': 'Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, New York.'}, {'ForeName': 'Sender', 'Initials': 'S', 'LastName': 'Herschorn', 'Affiliation': 'Department of Surgery/Urology, University of Toronto, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Kevin T', 'Initials': 'KT', 'LastName': 'McVary', 'Affiliation': 'Department of Urology, Stritch School of Medicine, Loyola University Medical Center, Maywood, Illinois.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Staskin', 'Affiliation': ""Division of Urology, St. Elizabeth's Medical Center, Tufts University School of Medicine, Boston, Massachusetts.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Chapple', 'Affiliation': 'Department of Urology, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Foley', 'Affiliation': 'Department of Urology, Royal Berkshire Hospital, Reading, UK.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cambronero Santos', 'Affiliation': 'Department of Urology, Infanta Leonor Hospital, Madrid, Spain.'}, {'ForeName': 'Rita M', 'Initials': 'RM', 'LastName': 'Kristy', 'Affiliation': 'Astellas Pharma Global Development Inc., Northbrook, Illinois.'}, {'ForeName': 'Nurul', 'Initials': 'N', 'LastName': 'Choudhury', 'Affiliation': 'Astellas Pharma Europe Ltd., Chertsey, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hairston', 'Affiliation': 'Astellas Pharma Global Development Inc., Northbrook, Illinois.'}, {'ForeName': 'Carol R', 'Initials': 'CR', 'LastName': 'Schermer', 'Affiliation': 'Astellas Pharma Global Development Inc., Northbrook, Illinois.'}]",The Journal of urology,['10.1097/JU.0000000000000738']
422,30687908,Efficacy and safety of non-ablative vaginal erbium:YAG laser treatment as a novel surgical treatment for overactive bladder syndrome: comparison with anticholinergics and β3-adrenoceptor agonists.,"PURPOSE


To examine the efficacy and safety of non-ablative vaginal erbium:YAG laser (VEL) for the treatment of overactive bladder syndrome (OAB) compared with those of two other common pharmacotherapies, namely, anticholinergics and β3-adrenoceptor agonists.
METHODS


Female subjects aged 60-69 years who presented with symptoms of OAB from 2015 to 2017 were assigned to three groups (n = 50) receiving treatment with an anticholinergic agent (4 mg fesoterodine), a β3-adrenoceptor agonist (25 mg mirabegron), or VEL (20 min/session of VEL performed thrice). The OAB symptom score (OABSS), Vaginal Health Index Scale (VHIS), and occurrence of adverse effects were examined prior to and at 1 year following treatment initiation.
RESULTS


The three groups showed significant improvement (p < 0.001) for all items of the OABSS questionnaire. Improved VHIS scores were observed only in the VEL group. Furthermore, after VEL treatment, a negative correlation was observed between questions 3 (urinary urgency) and 4 (urgency urinary incontinence) of the OABSS and VHIS. Regarding safety, no adverse events were observed in the VEL group. However, subjects in the other two groups complained of constipation, as indicated by the Constipation Assessment Scale scores, and mouth dryness. The therapeutic effects were inadequate for one and two subjects in the VEL and β3-adrenoceptor agonist groups, respectively.
CONCLUSIONS


VEL safely and effectively improved OABSS through a different mechanism than that involved in pharmacotherapy. We propose the use of VEL as a novel surgical treatment option in the field of urology.",2019,The three groups showed significant improvement (p < 0.001) for all items of the OABSS questionnaire.,"['overactive bladder syndrome (OAB', 'overactive bladder syndrome', 'Female subjects aged 60-69\xa0years who presented with symptoms of OAB from 2015 to 2017 were assigned to three groups (n\u2009=\u200950) receiving treatment with an']","['VEL', 'non-ablative vaginal erbium:YAG laser treatment', 'anticholinergic agent (4\xa0mg fesoterodine', 'non-ablative vaginal erbium:YAG laser (VEL', 'β3-adrenoceptor agonist (25\xa0mg mirabegron), or VEL', 'anticholinergics and β3-adrenoceptor agonists']","['Improved VHIS scores', 'Constipation Assessment Scale scores, and mouth dryness', 'OABSS', 'adverse events', 'questions 3 (urinary urgency) and 4 (urgency urinary incontinence) of the OABSS and VHIS', 'Efficacy and safety', 'complained of constipation', 'OAB symptom score (OABSS), Vaginal Health Index Scale (VHIS), and occurrence of adverse effects', 'efficacy and safety']","[{'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0014688', 'cui_str': 'Erbium'}, {'cui': 'C0587723', 'cui_str': 'Lasers, Yttrium Aluminum Garnet'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242896', 'cui_str': 'Anticholinergic Agents'}, {'cui': 'C2343853', 'cui_str': 'fesoterodine'}, {'cui': 'C0034783', 'cui_str': 'Adrenoceptors'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}]","[{'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate (finding)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0222045'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0172745,The three groups showed significant improvement (p < 0.001) for all items of the OABSS questionnaire.,"[{'ForeName': 'Nobuo', 'Initials': 'N', 'LastName': 'Okui', 'Affiliation': ""Uro-Gyn.Net Health Care Cooperation, Dr. Okuis' Urogynecology and Urology Clinic, Ootaki 2-6, Yokosuka, Kanagawa, 238-0008, Japan. okuinobuo@gmail.com.""}]",World journal of urology,['10.1007/s00345-019-02644-7']
423,32171064,"Predictive value of blood eosinophils and exhaled nitric oxide in adults with mild asthma: a prespecified subgroup analysis of an open-label, parallel-group, randomised controlled trial.","BACKGROUND


Whether blood eosinophil counts and exhaled nitric oxide (FeNO) are associated with important outcomes in mild asthma is unclear. In this prespecified subgroup analysis of a previously published open-label clinical trial, we aimed to assess associations between blood eosinophil counts and FeNO with outcomes and response to asthma treatment.
METHODS


In the previously reported 52-week, open-label, randomised controlled trial, people with mild asthma receiving only β agonist reliever inhalers were enrolled at one of 16 clinical trials units in New Zealand, the UK, Italy, or Australia. Eligible participants were randomly assigned (1:1:1, stratified by country), to receive inhalers to take as-needed salbutamol (two inhalations of 100 μg in a pressurised metered dose inhaler), maintenance budesonide (200 μg twice per day by inhaler) plus as-needed salbutamol (two inhalations of 100 μg), or as-needed budesonide-formoterol (one inhalation of 200 μg budesonide and 6μg formoterol by inhaler). The primary outcome was the annual rates of asthma exacerbations per patient, and in this prespecified subgroup analysis, we assessed whether annual exacerbation rates in each treatment group were significantly different depending on levels of blood eosinophil count, FeNO, or a composite score of both. Analyses were done for patients with available biomarker measurements The study was registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12615000999538.
FINDINGS


675 participants were enrolled between March 17, 2016, and Aug 29, 2017, of whom 656 had results for blood eosinophil analysis and 668 had results for FeNO. Of the patients who received as-needed salbutamol, the proportion of patients having a severe exacerbation increased progressively with increasing blood eosinophil count (two [4%] of 49 participants with <0·15 × 10 9 /L, six [6%] of 93 with 0·15 to <0·3 × 10 9 /L, and 15 [19%] of 77 with ≥0·3 × 10 9 /L; p=0·014). There were no significant interactions between blood eosinophil count or FeNO level and the effect of as-needed budesonide-formoterol compared with as-needed salbutamol for either exacerbations or severe exacerbations. However, there were significant interactions between blood eosinophil count subgroups and the effect of maintenance budesonide plus as-needed salbutamol compared with as-needed salbutamol, both for exacerbations (p=0·0006) and severe exacerbations (p=0·0007). Maintenance budesonide plus as-needed salbutamol was more effective than as-needed salbutamol in patients with blood eosinophil counts of 0·3 × 10 9 /L or more, both for exacerbations (rate ratio 0·13 [95% CI 0·05-0·33]) and severe exacerbations (risk odds ratio 0·11 [0·03-0·45]). This difference was not seen for blood eosinophil counts of less than 0·15 × 10 9 /L (1·15 [0·51-1·28] for exacerbations and 5·72 [0·97-33·60] for severe exacerbations). There was no consistent interaction between treatment response and FeNO or the composite score.
INTERPRETATION


In patients with mild asthma, the effects of as-needed budesonide-formoterol on exacerbations are independent of biomarker profile, whereas the benefits of maintenance inhaled budesonide are greater in patients with high blood eosinophil counts than in patients with low counts.
FUNDING


AstraZeneca, Health Research Council of New Zealand.",2020,This difference was not seen for blood eosinophil counts of less than 0·15 ,"['10', 'patients with blood eosinophil counts of 0·3', '675 participants were enrolled between March 17, 2016, and Aug 29, 2017, of whom 656 had results for blood eosinophil analysis and 668 had results for FeNO', 'people with mild asthma receiving only β agonist reliever inhalers were enrolled at one of 16 clinical trials units in New Zealand, the UK, Italy, or Australia', '0·13', 'patients with available biomarker measurements', '10 9', '49 participants with <0·15', 'patients with mild asthma', 'adults with mild asthma', 'Eligible participants']","['budesonide-formoterol', 'blood eosinophils and exhaled nitric oxide', 'salbutamol (two inhalations of 100 μg in a pressurised metered dose inhaler), maintenance budesonide (200 μg twice per day by inhaler) plus as-needed salbutamol (two inhalations of 100 μg), or as-needed budesonide-formoterol (one inhalation of 200 μg budesonide and 6μg formoterol by inhaler']","['blood eosinophil count', 'annual exacerbation rates', 'blood eosinophil counts', 'severe exacerbations', 'annual rates of asthma exacerbations', 'exacerbations (rate ratio', 'blood eosinophil count or FeNO level', 'levels of blood eosinophil count, FeNO, or a composite score of both']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C4517854', 'cui_str': '675 (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]","[{'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",675.0,0.625881,This difference was not seen for blood eosinophil counts of less than 0·15 ,"[{'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Pavord', 'Affiliation': 'Oxford Respiratory National Institute for Health Research Biomedical Research Centre, Nuffield Department of Medicine, University of Oxford, Oxford, UK. Electronic address: ian.pavord@ndm.ox.ac.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Holliday', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Helen K', 'Initials': 'HK', 'LastName': 'Reddel', 'Affiliation': 'Woolcock Institute of Medical Research, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Braithwaite', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ebmeier', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hancox', 'Affiliation': 'Department of Respiratory Medicine, Waikato Hospital, Hamilton, New Zealand; Department of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Harrison', 'Affiliation': 'Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Houghton', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Oldfield', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Papi', 'Affiliation': 'Respiratory Medicine Unit, Department of Medical Sciences, Università di Ferrara, Ferrara, Italy.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Weatherall', 'Affiliation': 'University of Otago Wellington, Wellington, New Zealand.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand; Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30053-9']
424,32166429,"Effectiveness of maintenance therapy with methotrexate compared with leflunomide for patients with RA having achieved disease control with both these drugs: results of a predefined sub-analysis of CareRA, a pragmatic RCT.","INTRODUCTION/OBJECTIVES


Evidence regarding the effectiveness of step-down strategies for patients with well-controlled early rheumatoid arthritis (RA) on a combination of methotrexate (MTX) and leflunomide (LEF) is currently lacking.
METHOD


The Care in early RA (CareRA) trial is a 2-year randomized pragmatic trial comparing different remission induction strategies in treatment-naïve patients with early RA. For this study, we included participants who achieved low disease activity (LDA) (DAS28-CRP ≤ 3.2) between 40 to 52 weeks after starting a combination of MTX, LEF, and a prednisone bridging scheme followed by a treat-to-target approach. Patients were re-randomized to a maintenance monotherapy of either MTX 15 mg weekly or LEF 20 mg daily. Remission rates (DAS28-CRP < 2.6) at week 65 counted from re-randomization, as well as drug retention rates and safety during the 65 weeks of follow-up, were compared.
RESULTS


Remission rates at week 65 after re-randomization were numerically higher in patients assigned to MTX (29/32; 90.6%) compared with patients on LEF (20/27; 74.1%) (p = 0.091). Of patients assigned to MTX, 60% (19/32) maintained LDA while continuing their assigned monotherapy until week 65 after re-randomization versus 44% (12/27) in the LEF group (p = 0.25). Patients re-randomized to MTX were more frequently in LDA measured by Clinical Disease Activity Index (32/32; 100%) compared with patients on LEF (23/27; 85.2%) (p = 0.024) 65 weeks after re-randomization. According to survival analyses, the probability of maintaining MTX monotherapy was higher (81%) than maintaining LEF monotherapy (55%) for 65 weeks (p = 0.025) after re-randomization. Safety analysis after re-randomization showed a good safety profile in both groups.
CONCLUSION


MTX monotherapy seems not significantly more efficacious as maintenance treatment compared with LEF monotherapy but has a better retention rate and is well tolerated in early RA patients in LDA after combination therapy with both.
TRIAL REGISTRATION


Clinical trials NCT01172639 Key points • Methotrexate should be preferred over leflunomide as maintenance therapy after an initial intensive combination of these two drugs. • Methotrexate shows a better retention rate to leflunomide as maintenance therapy in this context.",2020,"CONCLUSION


MTX monotherapy seems not significantly more efficacious as maintenance treatment compared with LEF monotherapy but has a better retention rate and is well tolerated in early RA patients in LDA after combination therapy with both.
","['participants who achieved low disease activity (LDA) (DAS28-CRP ≤\u20093.2) between 40 to 52\xa0weeks after starting a combination of', 'patients with well-controlled early rheumatoid arthritis (RA', 'patients with RA having achieved disease control with both these drugs', 'treatment-naïve patients with early RA']","['methotrexate', 'methotrexate (MTX) and leflunomide (LEF', 'Methotrexate', 'MTX', 'MTX 15\xa0mg weekly or LEF 20\xa0mg daily', 'leflunomide', 'MTX, LEF, and a prednisone bridging scheme followed by a treat-to-target approach', 'LEF monotherapy']","['Remission rates', 'probability of maintaining MTX monotherapy', 'LDA measured by Clinical Disease Activity Index', 'retention rate']","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0063041', 'cui_str': 'leflunomide'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0456378', 'cui_str': 'Type of bridge (attribute)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",,0.363574,"CONCLUSION


MTX monotherapy seems not significantly more efficacious as maintenance treatment compared with LEF monotherapy but has a better retention rate and is well tolerated in early RA patients in LDA after combination therapy with both.
","[{'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Stouten', 'Affiliation': 'KU Leuven, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, Herestraat 49, 3000, Leuven, Belgium. Veerle.stouten@kuleuven.be.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Michiels', 'Affiliation': 'University Hospitals Leuven, Division of Rheumatology, 3000, Leuven, Belgium.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Westhovens', 'Affiliation': 'KU Leuven, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'Diederik', 'Initials': 'D', 'LastName': 'De Cock', 'Affiliation': 'KU Leuven, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Belba', 'Affiliation': 'KU Leuven, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Pazmino', 'Affiliation': 'KU Leuven, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'Kristien', 'Initials': 'K', 'LastName': 'Van der Elst', 'Affiliation': 'University Hospitals Leuven, Division of Rheumatology, 3000, Leuven, Belgium.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Joly', 'Affiliation': 'University Hospitals Leuven, Division of Rheumatology, 3000, Leuven, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Verschueren', 'Affiliation': 'KU Leuven, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, Herestraat 49, 3000, Leuven, Belgium.'}]",Clinical rheumatology,['10.1007/s10067-020-05008-4']
425,32158348,"Effects of Carbohydrate Mouth Rinsing on Salivary Lysozyme, Mood States and Running Performance Among Recreational Runners.","Introduction


Carbohydrate (CHO) mouth rinsing can enhance sports performance through a central action mediated by receptors in the mouth. This study examined the effect of a CHO mouth rinse on salivary lysozyme concentrations, mood states and running performances.
Methods


Ten males recreational runners were randomised to three running trials with a 1 week recovery period between the trials. Each trial involved running at 75% maximum heart rate (HRmax) for 1 h, followed by a 15 min time trial. The participants used a CHO mouth rinse, placebo (PLA) solution or control (CON, no solution) every 15 min during the exercise. Heart rate (HR), rating of perceived exertion (RPE) and mood states were recorded pre-, during and post-exercise. Saliva samples were collected pre-, post- and 1 h post-exercise.
Results


There was no significant interaction and time effect ( P  > 0.05) on the salivary lysozyme concentration and running performance, but it was significant ( P  < 0.05) for HR and RPE (increase in all trials). However, there was no significant difference ( P  > 0.05) in salivary lysozyme concentrations, running performances, HR values or RPE between the trials. Mood states were not significantly different ( P  > 0.05) between the trials, but one of the mood sub-scales showed a significant ( P  < 0.001) time effect (increase fatigue in all trials).
Conclusion


CHO mouth rinsing did not affect physiological parameters, salivary lysozyme concentrations, mood states or running performance among recreational runners.",2020,"There was no significant interaction and time effect ( P  > 0.05) on the salivary lysozyme concentration and running performance, but it was significant ( P  < 0.05) for HR and RPE","['Recreational Runners', 'Methods\n\n\nTen males recreational runners']","['Introduction\n\n\nCarbohydrate (CHO) mouth rinsing', 'Carbohydrate Mouth Rinsing', 'CHO mouth rinse, placebo (PLA) solution or control (CON, no solution', 'CHO mouth rinse', 'RPE']","['physiological parameters, salivary lysozyme concentrations, mood states or running performance', 'salivary lysozyme concentrations, running performances, HR values or RPE', 'salivary lysozyme concentration and running performance', 'Salivary Lysozyme, Mood States and Running Performance', 'Heart rate (HR), rating of perceived exertion (RPE) and mood states', 'Mood states', 'salivary lysozyme concentrations, mood states and running performances']","[{'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C1293116', 'cui_str': 'Introduction'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C3541379', 'cui_str': 'lysozyme'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0035953', 'cui_str': 'Running'}]",10.0,0.346184,"There was no significant interaction and time effect ( P  > 0.05) on the salivary lysozyme concentration and running performance, but it was significant ( P  < 0.05) for HR and RPE","[{'ForeName': 'Ayu Suzailiana', 'Initials': 'AS', 'LastName': 'Muhamad', 'Affiliation': 'Exercise and Sports Science Programme, School of Health Sciences, Universiti Sains Malaysia, Kelantan, Malaysia.'}, {'ForeName': 'Nurul Fatin Raihan Mohd', 'Initials': 'NFRM', 'LastName': 'Puad', 'Affiliation': 'Exercise and Sports Science Programme, School of Health Sciences, Universiti Sains Malaysia, Kelantan, Malaysia.'}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Kuan', 'Affiliation': 'Exercise and Sports Science Programme, School of Health Sciences, Universiti Sains Malaysia, Kelantan, Malaysia.'}]",The Malaysian journal of medical sciences : MJMS,['10.21315/mjms2020.27.1.9']
426,32162278,A stepwise titration protocol for oral appliance therapy in positional obstructive sleep apnea patients: proof of concept.,"PURPOSE


In patients with positional obstructive sleep apnea (POSA), oral appliance therapy (OAT) is among the first-line treatments. The aim of this study was to evaluate the effects of a new standardized stepwise titration protocol for OAT in a group of patients with POSA.
METHODS


This was an observational intervention trial. Patients who were previously randomized to the OAT intervention arm of a comparison study comprised the subjects for this study. These patients, who had mild to moderate POSA, were assessed after 3 and 12 months for treatment efficacy, objective adherence by temperature microsensor, and side effects. The titration of OAT was performed using a standardized stepwise titration protocol including advancement levels of 60%, 75%, and 90% of the maximum mandibular protrusion. The optimal advancement level per individual was based on a weighted compromise between efficacy and side effects.
RESULTS


In total, 36 patients were included and all completed the titration protocol after 3 months. At baseline, the OAT was set at 60% of the maximal mandibular protrusion position. At a 3-month evaluation, the advancement remained at 60% in 16 patients (44%) and reached 75% advancement in 20 patients (56%). Mean apnea-hypopnea index decreased from 12.9 events per hour (9.1-16.7) to 6.9 (3.7-10.3) (P < 0.001), and median objective adherence was 97.4 (61.4-100.00) after 3 months. The 12-month analysis showed consistent results and good OAT tolerance. Six patients (16.7%) terminated OAT and one patient (2.8%) was lost to follow-up.
CONCLUSIONS


This standardized stepwise titration protocol for OAT showed good efficacy, good OAT tolerance, and good objective adherence in patients with mild to moderate POSA. Therefore, the protocol is recommended in research projects to improve standardization of methods between studies and in clinical practice for its practical feasibility.",2020,"Mean apnea-hypopnea index decreased from 12.9 events per hour (9.1-16.7) to 6.9 (3.7-10.3) (P < 0.001), and median objective adherence was 97.4 (61.4-100.00) after 3 months.","['positional obstructive sleep apnea patients', '36 patients were included and all completed the titration protocol after 3 months', 'patients with POSA.\nMETHODS', 'patients with positional obstructive sleep apnea (POSA', 'patients with mild to moderate POSA']","['oral appliance therapy (OAT', 'OAT intervention']","['median objective adherence', 'Mean apnea-hypopnea index', 'good OAT tolerance']","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0243112'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0028753', 'cui_str': 'Oats (substance)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0028753', 'cui_str': 'Oats (substance)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}]",36.0,0.0493953,"Mean apnea-hypopnea index decreased from 12.9 events per hour (9.1-16.7) to 6.9 (3.7-10.3) (P < 0.001), and median objective adherence was 97.4 (61.4-100.00) after 3 months.","[{'ForeName': 'M H T', 'Initials': 'MHT', 'LastName': 'de Ruiter', 'Affiliation': 'Department of Oral and Maxillofacial Surgery of the Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands. m.h.deruiter@amsterdamumc.nl.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Aarab', 'Affiliation': 'Department of Orofacial Pain and Dysfunction of the Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'de Vries', 'Affiliation': 'Department of Orofacial Pain and Dysfunction of the Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lobbezoo', 'Affiliation': 'Department of Orofacial Pain and Dysfunction of the Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'de Lange', 'Affiliation': 'Department of Oral and Maxillofacial Surgery of the Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-020-02045-w']
427,31855009,Evaluating the combination of a Brief Motivational Intervention plus Cognitive Behavioral Therapy for Depression and heavy episodic drinking in college students.,"[Correction Notice: An Erratum for this article was reported in Vol 34(2) of  Psychology of Addictive Behaviors  (see record 2020-16883-001). In the original article the order of authorship was incorrect. The correct second and third authors should appear instead as Brian Borsari and Jennifer E. Merrill.] Heavy episodic drinking (HED) and depressive symptoms often co-occur among college students and are associated with significant impairment. However, evidence-based treatments for these common co-occurring conditions are not available for college students. The current study compared the effectiveness of a treatment combining Cognitive-Behavioral Therapy for Depression and Brief Motivational Interviewing (CBT-D + BMI) versus Cognitive-Behavioral Therapy for Depression (CBT-D) alone among 94 college students with HED and depressive symptoms. Both treatment programs were associated with significant reductions of similar magnitude in HED, alcohol-related problems (ARP), and depressive symptoms at the end of treatment and at the 1-month follow-up assessment. Moderation analyses indicated that, among college students with fewer depressive symptoms at baseline, CBT-D was associated with greater sustained reduction in heavy drinking relative to CBT-D + BMI at the 1-month follow-up. Although the study did not include a no-treatment condition, the magnitude of improvement during treatment in both groups was greater than what is expected with passage of time. Although clinicians in college counseling centers may lack specialty training for co-occurring conditions, CBT-D is widely implemented in college settings. Our findings suggest that CBT-D may reduce both depressive symptoms and HED in college students and may be used to address a significant public health problem. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,"Both treatment programs were associated with significant reductions of similar magnitude in HED, alcohol-related problems (ARP), and depressive symptoms at the end of treatment and at the 1-month follow-up assessment.","['Vol 34(2) of  Psychology of Addictive Behaviors  (see record 2020-16883-001', 'college counseling centers', 'college students', '94 college students with HED and depressive symptoms']","['CBT-D', 'Motivational Intervention plus Cognitive Behavioral Therapy', 'Cognitive-Behavioral Therapy for Depression and Brief Motivational Interviewing (CBT-D + BMI) versus Cognitive-Behavioral Therapy']","['HED, alcohol-related problems (ARP), and depressive symptoms', 'Heavy episodic drinking (HED) and depressive symptoms', 'Depression and heavy episodic drinking', 'depressive symptoms']","[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",,0.0298664,"Both treatment programs were associated with significant reductions of similar magnitude in HED, alcohol-related problems (ARP), and depressive symptoms at the end of treatment and at the 1-month follow-up assessment.","[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Pedrelli', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Borsari', 'Affiliation': 'San Francisco VA Health Care System.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Merrill', 'Affiliation': 'Center for Alcohol and Addiction Studies.'}, {'ForeName': 'Lauren B', 'Initials': 'LB', 'LastName': 'Fisher', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Nyer', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Benjamin G', 'Initials': 'BG', 'LastName': 'Shapero', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Farabaugh', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Emma R', 'Initials': 'ER', 'LastName': 'Hayden', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'M Taylor', 'Initials': 'MT', 'LastName': 'Levine', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Roger D', 'Initials': 'RD', 'LastName': 'Weiss', 'Affiliation': 'Department of Psychiatry.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000538']
428,31735645,"Transcranial direct current stimulation associated with physical-therapy in acute stroke patients - A randomized, triple blind, sham-controlled study.","BACKGROUND


Transcranial Direct Current Stimulation has been increasing in popularity in the last few years. Despite vast amounts of articles on the use of tDCS on stroke patients, very little has been done during the acute phase.
OBJECTIVES


Measure the effects of tDCS on functional and sensory outcomes throughout the first year post onset of stroke.
METHODS


50 acute stroke patients were randomized and placed into either the treatment or sham group. Anodal tDCS was applied (2 mA, 20 min) 5 times a week during the first month post stroke. Patients were evaluated with the Wolf Motor Function Test, the Semmes Weinstein Monofilament Test, the Upper Extremity section (UEFM), the Lower Extremity section (LEFM) and the Somatosensory section of the Fugl Meyer Test, the Tardieu Spasticity Scale, the Stroke Impact Scale (SIS), the Hospital Anxiety and Depression Scale (HADS) and the Barthel Index. Evaluations were held at 48 h post stroke, week 1, 2, 3, 4, 3 months, 6 months and 1 year.
RESULTS


There were statistically and clinically significant improvements after tDCS in all functional motor outcomes, and somatosensory functions. Differences between both groups for the main outcome (WMFT time) were 51% (p = 0.04) at one month, and 57% (p = 0.02) at one year.
CONCLUSION


tDCS seems to be an effective adjuvant to conventional rehabilitation techniques. If applied in the acute stages of stroke, functional recovery is not only accelerated, but improved, and results are maintained up to one-year post stroke.",2020,"Differences between both groups for the main outcome (WMFT time) were 51% (p = 0.04) at one month, and 57% (p = 0.02) at one year.
","['acute stroke patients', '50 acute stroke patients']","['Anodal tDCS', 'Transcranial direct current stimulation associated with physical-therapy', 'tDCS']","['functional motor outcomes, and somatosensory functions', 'functional and sensory outcomes', 'Wolf Motor Function Test, the Semmes Weinstein Monofilament Test, the Upper Extremity section (UEFM), the Lower Extremity section (LEFM) and the Somatosensory section of the Fugl Meyer Test, the Tardieu Spasticity Scale, the Stroke Impact Scale (SIS), the Hospital Anxiety and Depression Scale (HADS) and the Barthel Index']","[{'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0325001', 'cui_str': 'Wolves'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C0222045'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}]",,0.0437824,"Differences between both groups for the main outcome (WMFT time) were 51% (p = 0.04) at one month, and 57% (p = 0.02) at one year.
","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bornheim', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Liege University Hospital Center, Liege, Belgium; Department of Sport and Rehabilitation Sciences, University of Liege, Liege, Belgium. Electronic address: Stephen.bornheim@ulg.ac.be.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Croisier', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Liege University Hospital Center, Liege, Belgium; Department of Sport and Rehabilitation Sciences, University of Liege, Liege, Belgium.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Maquet', 'Affiliation': 'Department of Neurology, Liege University Hospital Center, Liege, Belgium.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Kaux', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Liege University Hospital Center, Liege, Belgium; Department of Sport and Rehabilitation Sciences, University of Liege, Liege, Belgium.'}]",Brain stimulation,['10.1016/j.brs.2019.10.019']
429,31714583,"A Randomized, Placebo-Controlled Double-Blind Trial of a Closed-Loop Glucagon System for Postbariatric Hypoglycemia.","BACKGROUND


Postbariatric hypoglycemia (PBH) can threaten safety and reduce quality of life. Current therapies are incompletely effective.
METHODS


Patients with PBH were enrolled in a double-blind, placebo-controlled, crossover trial to evaluate a closed-loop glucose-responsive automated glucagon delivery system designed to reduce severe hypoglycemia. A hypoglycemia detection and mitigation algorithm was embedded in the artificial pancreas system connected to a continuous glucose monitor (CGM, Dexcom) driving a patch infusion pump (Insulet) filled with liquid investigational glucagon (Xeris) or placebo (vehicle). Sensor/plasma glucose responses to mixed meal were assessed during 2 study visits. The system delivered up to 2 doses of study drug (300/150 μg glucagon or equal-volume vehicle) if triggered by the algorithm. Rescue dextrose was given for plasma glucose <55 mg/dL or neuroglycopenia.
RESULTS


Twelve participants (11 females/1 male, age 52 ± 2, 8 ± 1 years postsurgery, mean ± SEM) completed all visits. Predictive hypoglycemia alerts prompted automated drug delivery postmeal, when sensor glucose was 114 ± 7 vs 121 ± 5 mg/dL (P = .39). Seven participants required rescue glucose after vehicle but not glucagon (P = .008). Five participants had severe hypoglycemia (<55 mg/dL) after vehicle but not glucagon (P = .03). Nadir plasma glucose was higher with glucagon vs vehicle (67 ± 3 vs 59 ± 2 mg/dL, P = .004). Plasma glucagon rose after glucagon delivery (1231 ± 187 vs 16 ± 1 pg/mL at 30 minutes, P = .001). No rebound hyperglycemia occurred. Transient infusion site discomfort was reported with both glucagon (n = 11/12) and vehicle (n = 10/12). No other adverse events were observed.
CONCLUSION


A CGM-guided closed-loop rescue system can detect imminent hypoglycemia and deliver glucagon, reducing severe hypoglycemia in PBH.
CLINICAL TRIALS REGISTRATION


NCT03255629.",2020,Five participants had severe hypoglycemia (<55 mg/dL) after vehicle but not glucagon (p=0.03).,"['Post-Bariatric Hypoglycemia', 'Twelve participants (11F/1M, age 52+2, 8+1 years post-surgery, mean+SEM) completed all visits', 'Patients with PBH']","['Placebo', 'Rescue dextrose', 'glucagon', 'closed-loop glucose-responsive automated glucagon delivery system', 'liquid investigational glucagon (Xeris) or placebo (vehicle', 'placebo', 'Closed-Loop Glucagon System']","['Transient infusion site discomfort', 'severe hypoglycemia', 'adverse events', 'quality of life', 'rebound hyperglycemia', 'Sensor/plasma glucose responses', 'Plasma glucagon', 'rescue glucose', 'Nadir plasma glucose']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0449914', 'cui_str': 'Delivery system (attribute)'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C2721735', 'cui_str': 'Infusion site discomfort'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034380'}, {'cui': 'C0342314', 'cui_str': 'Dawn phenomenon (disorder)'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C1278023', 'cui_str': 'Plasma glucagon measurement'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]",12.0,0.478453,Five participants had severe hypoglycemia (<55 mg/dL) after vehicle but not glucagon (p=0.03).,"[{'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Mulla', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA.'}, {'ForeName': 'Stamatina', 'Initials': 'S', 'LastName': 'Zavitsanou', 'Affiliation': 'Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA.'}, {'ForeName': 'Alejandro Jose', 'Initials': 'AJ', 'LastName': 'Laguna Sanz', 'Affiliation': 'Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pober', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Richardson', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Walcott', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA.'}, {'ForeName': 'Ipsa', 'Initials': 'I', 'LastName': 'Arora', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Newswanger', 'Affiliation': 'Xeris Pharmaceuticals, Chicago, IL.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Cummins', 'Affiliation': 'Xeris Pharmaceuticals, Chicago, IL.'}, {'ForeName': 'Steve J', 'Initials': 'SJ', 'LastName': 'Prestrelski', 'Affiliation': 'Xeris Pharmaceuticals, Chicago, IL.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Doyle', 'Affiliation': 'Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Dassau', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA.'}, {'ForeName': 'Mary Elizabeth', 'Initials': 'ME', 'LastName': 'Patti', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz197']
430,30561577,Mass Oral Azithromycin for Childhood Mortality: Timing of Death After Distribution in the MORDOR Trial.,"In a large community-randomized trial, biannual azithromycin distributions significantly reduced postneonatal childhood mortality in sub-Saharan African sites. Here, we present a prespecified secondary analysis showing that much of the protective effect was in the first 3 months postdistribution. Distributing more frequently than biannually could be considered if logistically feasible. Clinical Trials Registration. NCT02047981.",2019,"In a large community-randomized trial, biannual azithromycin distributions significantly reduced postneonatal childhood mortality in sub-Saharan African sites.","['Childhood Mortality', 'sub-Saharan African sites']","['biannual azithromycin', 'Azithromycin']","['Timing of Death', 'postneonatal childhood mortality']","[{'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.134499,"In a large community-randomized trial, biannual azithromycin distributions significantly reduced postneonatal childhood mortality in sub-Saharan African sites.","[{'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hart', 'Affiliation': 'London School of Hygiene and Tropical Medicine, United Kingdom.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Arzika', 'Affiliation': 'The Carter Center, Niamey, Niger.'}, {'ForeName': 'Jerusha', 'Initials': 'J', 'LastName': 'Weaver', 'Affiliation': 'The Dana Center, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Kalua', 'Affiliation': 'Blantyre Institute for Community Outreach, Blantyre.'}, {'ForeName': 'Zakayo', 'Initials': 'Z', 'LastName': 'Mrango', 'Affiliation': 'National Institute for Medical Research, Dar es Salaam, Tanzania.'}, {'ForeName': 'Sun Y', 'Initials': 'SY', 'LastName': 'Cotter', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Stoller', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco.'}, {'ForeName': 'Kieran S', 'Initials': 'KS', 'LastName': ""O'Brien"", 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco.'}, {'ForeName': 'Dionna M', 'Initials': 'DM', 'LastName': 'Fry', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Vanderschelden', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco.'}, {'ForeName': 'Sheila K', 'Initials': 'SK', 'LastName': 'West', 'Affiliation': 'The Dana Center, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'London School of Hygiene and Tropical Medicine, United Kingdom.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy973']
431,30196720,Improving Patient-Provider Communication and Therapeutic Practice Through Better Integration of Electronic Health Records in the Exam Room: A Pilot Study.,"BACKGROUND


The rapid proliferation of electronic health records (EHRs) in clinics has had mixed impact on patient-centered communication, yet few evaluated interventions exist to train practicing providers in communication practices.
AIMS


We extended the evidence-based Physician Asthma Care Education (PACE) program with EHR-specific communication strategies, and tested whether training providers with the extended program (EHR-PACE) would improve provider and patient perceptions of provider communication skills and asthma outcomes of patients.
METHOD


A pilot randomized design was used to compare EHR-PACE with usual care. Participants were providers ( n = 18) and their adult patients with persistent asthma ( n = 126). Outcomes were assessed at baseline and 3- and 6-month postintervention, including patient perception of their provider's communication skills and provider confidence in using EHRs during clinical encounters.
RESULTS


Compared with the control group, providers who completed the EHR-PACE program reported significant improvements at 3-month follow-up in their confidence with asthma counseling practices (estimate 0.90, standard error [ SE] 0.4); p < .05) and EHR-specific communication practices (estimate 2.3, SE 0.8; p < .01), and at 6-month follow-up, a significant decrease in perception that the computer interferes with the patient-provider relationship (estimate -1.0, SE 0.3; p < .01). No significant changes were observed in patient asthma outcomes or their perception of their provider's communication skills.
DISCUSSION


Training providers with skills to accommodate EHR use in the exam room increases provider confidence and their perceived skills in maintaining patient-centered communications in the short term.
CONCLUSION


Evidence-supported training initiatives that can increase capacity of busy providers to manage increased computing demands shows promise. More research is needed to fully evaluate EHR-PACE on patients' health status and their perceptions of their provider's care through a large-scale trial.",2019,"No significant changes were observed in patient asthma outcomes or their perception of their provider's communication skills.
","['Participants were providers ( n = 18) and their adult patients with persistent asthma ( n = 126', 'patients']",['training providers with the extended program (EHR-PACE'],"['EHR-specific communication practices', ""patient perception of their provider's communication skills and provider confidence in using EHRs during clinical encounters"", ""patient asthma outcomes or their perception of their provider's communication skills""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]",126.0,0.0267886,"No significant changes were observed in patient asthma outcomes or their perception of their provider's communication skills.
","[{'ForeName': 'Minal R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': '1 University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': '1 University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Harvey', 'Initials': 'H', 'LastName': 'Leo', 'Affiliation': '1 University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hao', 'Affiliation': '1 University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zheng', 'Affiliation': '2 University of California Irvine, CA, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198118796879']
432,31255678,Modifying effects of depression on the association between BDNF methylation and prognosis of acute coronary syndrome.,"AIMS


Brain-derived neurotrophic factor (BDNF) plays important roles in angiogenesis, inflammation, and neuronal plasticity. BDNF methylation has been extensively investigated in depression, but not in cardiac diseases. We asked whether BDNF methylation status is associated with a major adverse cardiac event (MACE), inflammation, and the association with depression comorbidity and its treatment in patients with acute coronary syndrome (ACS).
METHODS AND RESULTS


A cross-sectional baseline study and nested 24 week double-blind escitalopram placebo-controlled trial (ClinicalTrial.gov identifier NCT00419471) were performed from 2006 to 2012, with 5-12 year follow-up for MACE. Patients with recent ACS (969 total) were divided into four groups according to depression comorbidity at baseline and treatment allocation: 591, absent depression; 127, depression on escitalopram; 128, depression on placebo; 123, depression on care as usual (CAU). BDNF methylation was measured in leucocyte DNA, and multiple demographic and clinical characteristics including interleukin 6 were evaluated as covariates at baseline. The primary outcome, time to first MACE (a composite of all-cause mortality, myocardial infarction and percutaneous coronary intervention), was investigated using Cox regression models after adjustment for covariates. Interleukin 6 level was significantly higher in patients with higher BDNF methylation values. Higher BDNF methylation was associated with increased MACE independent of confounding factors [HR (95% CI) = 1.45 (1.17-1.78)]. This association was significant in patients without depression [HR (95% CI) = 1.39 (1.01-1.90)] and depressive patients on placebo [HR (95% CI) = 1.72 (1.02-3.02)] or CAU [HR (95% CI) = 1.53 (1.01-2.61)], but not in those treated with escitalopram [HR (95% CI) = 1.00 (0.51-1.95)].
CONCLUSION


BDNF methylation was significantly associated with prognosis of ACS. Escitalopram may mitigate the deleterious effect of higher BDNF methylation in depressive patients with ACS. Further research is needed to elucidate the mechanistics and to assess the generalisability of these findings.",2019,Higher BDNF methylation was associated with increased MACE independent of confounding factors [HR (95% CI) = 1.45 (1.17-1.78)].,"['Patients with recent ACS (969 total) were divided into four groups according to depression comorbidity at baseline and treatment allocation: 591, absent depression; 127, depression on escitalopram; 128, depression on', 'patients with acute coronary syndrome (ACS', 'depressive patients with ACS', '2006 to 2012, with 5-12\u202fyear follow-up for MACE']","['placebo; 123, depression on care as usual (CAU', 'escitalopram placebo']","['BDNF methylation', 'Higher BDNF methylation', 'time to first MACE (a composite of all-cause mortality, myocardial infarction and percutaneous coronary intervention', 'Interleukin 6 level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0444892', 'cui_str': 'CAU'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}]","[{'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.261167,Higher BDNF methylation was associated with increased MACE independent of confounding factors [HR (95% CI) = 1.45 (1.17-1.78)].,"[{'ForeName': 'Jae-Min', 'Initials': 'JM', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea. Electronic address: jmkim@chonnam.ac.kr.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Stewart', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, England; South London and Maudsley NHS Foundation Trust, London, England.""}, {'ForeName': 'Ju-Wan', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Hee-Ju', 'Initials': 'HJ', 'LastName': 'Kang', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Ju-Yeon', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Seon-Young', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Sung-Wan', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Il-Seon', 'Initials': 'IS', 'LastName': 'Shin', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Young Joon', 'Initials': 'YJ', 'LastName': 'Hong', 'Affiliation': 'Department of Cardiology, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Youngkeun', 'Initials': 'Y', 'LastName': 'Ahn', 'Affiliation': 'Department of Cardiology, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Myung Ho', 'Initials': 'MH', 'LastName': 'Jeong', 'Affiliation': 'Department of Cardiology, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Jin-Sang', 'Initials': 'JS', 'LastName': 'Yoon', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2019.06.038']
433,32154732,Gender differences in the effectiveness of public education messages aimed at smartphone use among young drivers.,"Objective:  The main aim of this survey study was to evaluate the relative persuasiveness of three newly developed and piloted public education messages aimed at monitoring/reading social interactive technology on a smartphone among young male and female drivers. In accordance with the Step Approach to Message Design and Testing, the messages were evaluated on a number of outcome measures and also explored the influence of self-reported involvement in the target behavior. Methods:  Participants ( N  = 152; 105 F) were aged 17 to 25 years ( M age  = 20.14 years,  SD  = 2.35) and were randomly allocated to either an intervention (one of the three messages) or control (no message) condition. The messages in the intervention group were assessed on acceptance (i.e., behavioral intention and message effectiveness), rejection, and the third person effect (TPE) differential score (i.e., the message is perceived to be more effective for others than for themselves). Results:  Hierarchical regression analyses found that, compared to males, females reported: a) lower intention to monitor/read social interactive technology on a smartphone while driving, b) lower rejection; and, c) lower TPE likelihood, irrespective of message. Conclusions:  These findings suggest that young male drivers and young female drivers require different message content to be effective and support the importance of including multiple outcome measures to explain the messages' persuasive effects.",2020,"Results:  Hierarchical regression analyses found that, compared to males, females reported: a) lower intention to monitor","['Participants ( N \u2009=\u2009152; 105\u2009F) were aged 17 to 25\u2009years ( M age  = 20.14\u2009years,  SD \u2009=\u20092.35', 'young male drivers and young female drivers', 'young male and female drivers', 'young drivers']",['piloted public education messages aimed at monitoring/reading social interactive technology'],"['acceptance (i.e., behavioral intention and message effectiveness), rejection, and the third person effect (TPE) differential score']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.043007,"Results:  Hierarchical regression analyses found that, compared to males, females reported: a) lower intention to monitor","[{'ForeName': 'Cassandra S', 'Initials': 'CS', 'LastName': 'Gauld', 'Affiliation': 'Centre for Accident Research and Road Safety, Queensland University of Technology, Queensland, Australia.'}, {'ForeName': 'Ioni M', 'Initials': 'IM', 'LastName': 'Lewis', 'Affiliation': 'Centre for Accident Research and Road Safety, Queensland University of Technology, Queensland, Australia.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'White', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology, Queensland, Australia.'}, {'ForeName': 'Barry C', 'Initials': 'BC', 'LastName': 'Watson', 'Affiliation': 'Centre for Accident Research and Road Safety, Queensland University of Technology, Queensland, Australia.'}, {'ForeName': 'Chae T', 'Initials': 'CT', 'LastName': 'Rose', 'Affiliation': 'Centre for Accident Research and Road Safety, Queensland University of Technology, Queensland, Australia.'}, {'ForeName': 'Judy J', 'Initials': 'JJ', 'LastName': 'Fleiter', 'Affiliation': 'School of Psychology and Counselling, Queensland University of Technology, Queensland, Australia.'}]",Traffic injury prevention,['10.1080/15389588.2020.1732948']
434,32154734,"Infant car seat use in Japan after the antepartum distribution of an educational leaflet: A prospective, nonrandomized controlled trial with a questionnaire survey.","Objective:  To determine whether an antepartum educational leaflet distributed to parents before infant delivery affected the rate of infant car-seat (ICS) use 1 month after delivery, because to the best of our knowledge, only few reports have evaluated systematic attempts to improve the rate of always ICS use by mothers driving infants Methods:  A multicenter questionnaire survey targeting pregnant Japanese women seeking antenatal care at the outpatient clinics of eight hospitals was designed. Women enrolled during the first half of the study period did not receive leaflets describing ICS safety guidelines (control group). Women enrolled during the latter half of the study period received the leaflet between gestational week 35 and 37 (intervention group). All women were requested to anonymously respond to the questionnaires within 1 month postpartum. The rates of ICS use, position, and direction after delivery were compared between both groups. Results:  Of the 3534 women who responded to the questionnaire survey (response rate, 81.9%), 1772 women (50.1%) were assigned to the intervention group and 1762 (49.9%) women to the control group. The rates of ICS attachments (86.8% vs. 82.4% in the intervention and control groups, respectively,  p  = 0.0003), always ICS use (80.5% vs. 76.2%, respectively,  p  = 0.0019), ICS placement on the rear seat (78.6% vs. 74.1%, respectively,  p  = 0.0020), and ICS placement in a rear-facing position (62.2% vs. 56.7%, respectively,  p  = 0.0008) were significantly higher in the intervention group than those in the control group. The motor vehicle accident (MVA) rates within 1 month postpartum were similar between the intervention and control groups (0.51% vs. 0.57%, respectively,  p  = 0.8229). Conclusions:  Antepartum minimal intervention via the distribution of an educational leaflet recommending ICS safety guidelines was associated with increased rates of ICS attachments, always ICS use, and ICS placement on the rear seat and in rear-facing positions; however, it did not contribute to reduced MVA rates after delivery.",2020,"The rates of ICS attachments (86.8% vs. 82.4% in the intervention and control groups, respectively,  p  = 0.0003), always ICS use (80.5% vs. 76.2%, respectively,  p  = 0.0019), ICS placement on the rear seat (78.6% vs. 74.1%, respectively,  p  = 0.0020), and ICS placement in a rear-facing position (62.2% vs. 56.7%, respectively,  p  = 0.0008) were significantly higher in the intervention group than those in the control group.","['Women enrolled during the first half of the study period did not receive leaflets describing ICS safety guidelines (control group', 'pregnant Japanese women seeking antenatal care at the outpatient clinics of eight hospitals was designed', '3534 women who responded to the questionnaire survey (response rate, 81.9', '1772 women (50.1%) were assigned to the intervention group and 1762 (49.9%) women to the control group']",[],"['ICS placement on the rear seat', 'MVA rates', 'rates of ICS attachments', 'motor vehicle accident (MVA) rates', 'rates of ICS attachments, always ICS use, and ICS placement', 'always ICS use', 'rates of ICS use, position, and direction after delivery']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1283233', 'cui_str': 'Seating'}, {'cui': 'C2939181', 'cui_str': 'Motor vehicle traffic accident (event)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]",3534.0,0.0386861,"The rates of ICS attachments (86.8% vs. 82.4% in the intervention and control groups, respectively,  p  = 0.0003), always ICS use (80.5% vs. 76.2%, respectively,  p  = 0.0019), ICS placement on the rear seat (78.6% vs. 74.1%, respectively,  p  = 0.0020), and ICS placement in a rear-facing position (62.2% vs. 56.7%, respectively,  p  = 0.0008) were significantly higher in the intervention group than those in the control group.","[{'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Morikawa', 'Affiliation': 'Department of Obstetrics and Gynecology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Obstetrics and Gynecology, JCHO Hokkaido Hospital, Sapporo, Japan.'}, {'ForeName': 'Hiromasa', 'Initials': 'H', 'LastName': 'Kogo', 'Affiliation': ""Department of Obstetrics and Gynecology, Sapporo Maternity Women's Hospital, Sapporo, Japan.""}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Sugawara', 'Affiliation': 'Department of Obstetrics and Gynecology, Sapporo Toho Hospital, Sapporo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Obstetrics and Gynecology, NTT East Japan Sapporo General Hospital, Sapporo, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Fukushi', 'Affiliation': 'Department of Obstetrics and Gynecology, Teine Keijinkai Hospital, Sapporo, Japan.'}, {'ForeName': 'Emi', 'Initials': 'E', 'LastName': 'Kato-Hirayama', 'Affiliation': 'Department of Obstetrics and Gynecology, Sapporo City General Hospital, Sapporo, Japan.'}, {'ForeName': 'Shin-Ichi', 'Initials': 'SI', 'LastName': 'Ishioka', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Sapporo Medical University, Sapporo, Japan.'}, {'ForeName': 'Hidemichi', 'Initials': 'H', 'LastName': 'Watari', 'Affiliation': 'Department of Obstetrics and Gynecology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.'}]",Traffic injury prevention,['10.1080/15389588.2020.1733540']
435,31195056,Effects of Transcranial Static Magnetic Stimulation on Motor Cortex Evaluated by Different TMS Waveforms and Current Directions.,"Transcranial static magnetic stimulation (tSMS) modulates cortical excitability probably by interacting with the GABA-glutamate intracortical balance. Different transcranial magnetic stimulation (TMS) waveforms probe distinct GABA-mediated cortical inhibition networks. The goal of the present work is to further characterize tSMS-induced changes in motor cortex reactivity and inhibition-excitation (I/E) balance. We hypothesized that tSMS affects particular cortical networks and thus, the effects of tSMS would be different depending on the TMS waveform used to assess its results. 23 healthy young adults completed two sessions of real or sham tSMS. The order of the sessions was randomized across participants. Motor evoked potentials (MEPs), cortical silent period (CSP), short- and long-interval intracortical inhibition (SICI and LICI), and intracortical facilitation (ICF) were assessed with TMS monophasic posterior-anterior (mono PA ; n = 9), monophasic anterior-posterior (mono AP ; n = 7), or biphasic (bi AP-PA ; n = 7) pulses. Repeated measures analyses of variance and appropriate pairwise comparisons were performed for each TMS measure. After 15 min of real tSMS, the MEP amplitudes decreased compared to sham and baseline, SICI and LICI showed greater inhibition, and a tendency towards longer CSPs and less facilitation was found. These results were only observed with mono PA  TMS. MEP amplitude increased compared to sham with mono AP  TMS, with no clear changes in general intracortical I/E balance. Biphasic TMS was not able to capture any effects of tSMS. The results show that the effects of tSMS on cortical excitability and inhibition involve specific interneuron circuits that are selectively activated by mono PA  TMS.",2019,"After 15 min of real tSMS, the MEP amplitudes decreased compared to sham and baseline, SICI and LICI showed greater inhibition, and a tendency towards longer CSPs and less facilitation was found.",['23 healthy young adults'],"['tSMS', 'transcranial magnetic stimulation (TMS', 'sessions of real or sham tSMS', 'Biphasic TMS', 'Transcranial Static Magnetic Stimulation', 'Transcranial static magnetic stimulation (tSMS']","['Motor evoked potentials (MEPs), cortical silent period (CSP), short- and long-interval intracortical inhibition (SICI and LICI), and intracortical facilitation (ICF', 'Motor Cortex Evaluated by Different TMS Waveforms and Current Directions', 'MEP amplitudes', 'MEP amplitude', 'motor cortex reactivity and inhibition-excitation (I/E) balance', 'general intracortical I/E balance']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205184', 'cui_str': 'Biphasic (qualifier value)'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C0443304', 'cui_str': 'Silent (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C0444966', 'cui_str': 'ICF'}, {'cui': 'C0026607', 'cui_str': 'Somatomotor Areas'}, {'cui': 'C0450448', 'cui_str': 'Waveforms (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",23.0,0.0428241,"After 15 min of real tSMS, the MEP amplitudes decreased compared to sham and baseline, SICI and LICI showed greater inhibition, and a tendency towards longer CSPs and less facilitation was found.","[{'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Davila-Pérez', 'Affiliation': 'Berenson-Allen Center for Noninvasive Brain Stimulation and Division of Cognitive Neurology, Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; Neuroscience and Motor Control Group (NEUROcom), Institute for Biomedical Research (INIBIC), Universidade da Coruña, A Coruña, Spain. Electronic address: pdavila@bidmc.harvard.edu.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Pascual-Leone', 'Affiliation': 'Berenson-Allen Center for Noninvasive Brain Stimulation and Division of Cognitive Neurology, Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; Institut Guttman de Neurorehabilitació, Universitat Autónoma de Barcelona, Badalona, Barcelona, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cudeiro', 'Affiliation': 'Berenson-Allen Center for Noninvasive Brain Stimulation and Division of Cognitive Neurology, Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; Neuroscience and Motor Control Group (NEUROcom), Institute for Biomedical Research (INIBIC), Universidade da Coruña, A Coruña, Spain; Centro de Estimulación Cerebral de Galicia, A Coruña, Spain. Electronic address: javier.cudeiro@udc.es.'}]",Neuroscience,['10.1016/j.neuroscience.2019.05.065']
436,30718539,Combining attentional bias modification with dorsolateral prefrontal rTMS does not attenuate maladaptive attentional processing.,"High frequency repetitive Transcranial Magnetic Stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC) has been shown to reduce depressive symptoms and improve cognitive biases such as attentional bias. One promising technique that may complement rTMS treatment is attentional bias modification (ABM) training, given the similarity in modulating attentional bias and affecting neuronal activity. We tested whether the combination of rTMS treatment and ABM training in a single session would attenuate maladaptive attentional processing and improve mood in participants with subclinical depressive symptoms. To this end, 122 healthy participants were randomly assigned to one of four groups, receiving either a single rTMS treatment, a single ABM treatment, a combination of rTMS and ABM or a sham treatment. Of these 122 participants, 72 showed a heightened BDI-II score (between 9 and 25) and were included in our main analyses. In our subclinical (≥9 and ≤25 BDI-II) sample, a single combination treatment of rTMS and ABM training induced no significant changes in attentional bias, attentional control or mood, nor did rTMS alone affect attentional bias systematically. We discuss these null findings in light of the task specifics and relate them to the ongoing discussion on ABM training in depression.",2019,High frequency repetitive Transcranial Magnetic Stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC) has been shown to reduce depressive symptoms and improve cognitive biases such as attentional bias.,"['participants with subclinical depressive symptoms', '122 healthy participants', '122 participants, 72 showed a heightened BDI-II score (between 9 and 25) and were included in our main analyses']","['High frequency repetitive Transcranial Magnetic Stimulation (rTMS', 'rTMS treatment and ABM training', 'single rTMS treatment, a single ABM treatment, a combination of rTMS and ABM or a sham treatment', 'rTMS and ABM training']","['attentional bias, attentional control or mood', 'maladaptive attentional processing']","[{'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",122.0,0.0280187,High frequency repetitive Transcranial Magnetic Stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC) has been shown to reduce depressive symptoms and improve cognitive biases such as attentional bias.,"[{'ForeName': 'Leonore', 'Initials': 'L', 'LastName': 'Bovy', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Kapittelweg 29, 6525 EN, Nijmegen, The Netherlands. leonorebovy@gmail.com.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Möbius', 'Affiliation': 'Behavioural Science Institute, Radboud University Nijmegen, 6500 HE, Nijmegen, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dresler', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Kapittelweg 29, 6525 EN, Nijmegen, The Netherlands.'}, {'ForeName': 'Guillén', 'Initials': 'G', 'LastName': 'Fernández', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Kapittelweg 29, 6525 EN, Nijmegen, The Netherlands.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Sanfey', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Kapittelweg 29, 6525 EN, Nijmegen, The Netherlands.'}, {'ForeName': 'Eni', 'Initials': 'E', 'LastName': 'Becker', 'Affiliation': 'Behavioural Science Institute, Radboud University Nijmegen, 6500 HE, Nijmegen, The Netherlands.'}, {'ForeName': 'Indira', 'Initials': 'I', 'LastName': 'Tendolkar', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Kapittelweg 29, 6525 EN, Nijmegen, The Netherlands.'}]",Scientific reports,['10.1038/s41598-018-37308-w']
437,31428820,Efficacy and safety of CT-P6 versus reference trastuzumab in HER2-positive early breast cancer: updated results of a randomised phase 3 trial.,"PURPOSE


Neoadjuvant CT-P6, a trastuzumab biosimilar, demonstrated equivalent efficacy to reference trastuzumab in a phase 3 trial of HER2-positive early-stage breast cancer (EBC) (NCT02162667). We report post hoc analyses evaluating pathological complete response (pCR) and breast pCR alongside additional efficacy and safety measures.
METHODS


Following neoadjuvant treatment and surgery, patients received adjuvant CT-P6 or trastuzumab (6 mg/kg) every 3 weeks for ≤ 1 year.
RESULTS


In total, 271 and 278 patients received CT-P6 and trastuzumab, respectively. pCR and breast pCR rates were comparable between treatment groups regardless of age, region, or clinical stage. Overall, 47.6% (CT-P6) and 52.2% (trastuzumab) of patients experienced study drug-related treatment-emergent adverse events (TEAEs), including 17 patients reporting heart failure (CT-P6: 10; trastuzumab: 7). Two CT-P6 and three trastuzumab patients discontinued adjuvant treatment due to TEAEs.
CONCLUSION


Adjuvant CT-P6 demonstrated comparable efficacy and safety to trastuzumab at 1 year in patients with HER2-positive EBC, supporting CT-P6 and trastuzumab comparability.",2019,"pCR and breast pCR rates were comparable between treatment groups regardless of age, region, or clinical stage.",['HER2-positive early breast cancer'],"['trastuzumab', 'adjuvant CT-P6 or trastuzumab', 'CT-P6 versus reference trastuzumab', 'CT-P6 and trastuzumab']","['efficacy and safety', 'pCR and breast pCR rates', 'Efficacy and safety', 'pathological complete response (pCR) and breast pCR alongside additional efficacy and safety measures']","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0244191,"pCR and breast pCR rates were comparable between treatment groups regardless of age, region, or clinical stage.","[{'ForeName': 'F J', 'Initials': 'FJ', 'LastName': 'Esteva', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, 160 E 34th Street, New York, 10016, USA.'}, {'ForeName': 'Y V', 'Initials': 'YV', 'LastName': 'Baranau', 'Affiliation': 'Department of Oncology, Belarusian State Medical University, 220013, Minsk, Belarus.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Baryash', 'Affiliation': 'Department of Oncology, Belarusian State Medical University, 220013, Minsk, Belarus.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Manikhas', 'Affiliation': 'City Clinical Oncology Dispensary, Saint Petersburg, 198255, Russian Federation.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Moiseyenko', 'Affiliation': 'GBUZ Saint Petersburg Clinical Research Center of Specialised Types of Care (Oncology), Saint Petersburg, 197758, Russian Federation.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Dzagnidze', 'Affiliation': 'S. Khechinashvili University Clinic, Ltd, 0177, Tbilisi, Georgia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Zhavrid', 'Affiliation': 'N.N. Alexandrov National Cancer Centre of Belarus, 223040, Minsk Region, Belarus.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Boliukh', 'Affiliation': 'Vinnytsya Regional Clinical Oncology Dispensary, Vinnytsia, 21029, Ukraine.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Stroyakovskiy', 'Affiliation': 'Moscow City Oncology Hospital, Moscow, 143423, Russian Federation.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pikiel', 'Affiliation': 'Wojewodzkie Centrum Onkologii, 80-219, Gdańsk, Poland.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Eniu', 'Affiliation': 'Cancer Institute ""Ion Chiricuta"", 400015, Cluj-Napoca, Romania.'}, {'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Li', 'Affiliation': ""St. Luke's Medical Center, 1102, Quezon City, Philippines.""}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Rusyn', 'Affiliation': 'Transcarpathian Regional Clinical Oncology Dispensary, Transcarpathian, 88000, Ukraine.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Tiangco', 'Affiliation': 'The Medical City, Ortigas Avenue, Pasig City, Philippines.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'CELLTRION, Inc., Incheon, 22014, Republic of Korea.'}, {'ForeName': 'S Young', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'CELLTRION, Inc., Incheon, 22014, Republic of Korea.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Yu', 'Affiliation': 'CELLTRION, Inc., Incheon, 22014, Republic of Korea.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stebbing', 'Affiliation': 'Division of Cancer, Imperial Centre for Translational and Experimental Medicine, Du Cane Road, London, W12 0HS, UK. j.stebbing@imperial.ac.uk.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-019-03920-4']
438,31931236,Prognostic Significance of the Difference Between Mixed and Jugular Venous Oxygen Saturation After Severe Traumatic Brain Injury: A Post Hoc Analysis of the Brain Hypothermia Study.,"BACKGROUND


In patients postcardiac arrest, it has been reported that the small value of the difference between mixed venous oxygen saturation (Svo 2 ) and jugular venous oxygen saturation (Sjvo 2 ) is associated with poor neurologic outcome. However, the importance of the difference between mixed venous oxygen saturation and jugular venous oxygen saturation (ΔSo 2  [v - jv]) remains unknown in severe traumatic brain injury (TBI). The aim of this study was to examine whether ΔSo 2  (v - jv) is associated with neurologic outcome and mortality in patients with severe TBI.
METHODS


We conducted post hoc analyses of the Brain Hypothermia Study, a multicenter randomized controlled trial of mild therapeutic hypothermia for the treatment of severe TBI. The value of ΔSo 2 (v - jv) on day 1 and day 3 was compared between survivors (n = 65) and nonsurvivors (n = 25) or between patients with favorable (n = 47) and unfavorable (n = 43) neurologic outcomes.
RESULTS


The reduction in ΔSo 2  (v - jv) on day 3 was -2.0% (range, -6.9% to 6.5%) in the nonsurvivor group and 6.3% (range, -2.5% to 16.7%) in the survivor group. The difference was statistically significant (P = 0.03). The same tendencies were observed in the nonsurvivor group on day 1 and in the unfavorable neurologic outcome group on day 1 and day 3, but the difference was not significant.
CONCLUSIONS


The reduction in ΔSo 2 (v - jv) on day 3 was associated with high mortality in patients with severe TBI.",2020,The reduction in ΔSO 2 (v-jv) on day 3 was associated with high mortality in severe TBI patients.,"['severe TBI', 'severe TBI patients', 'severe traumatic brain injury', 'survivors (n=65) and non-survivors (n=25) or between patients with favorable (n=47) and unfavorable (n=43) neurological outcomes']","['mild therapeutic hypothermia', 'mixed and jugular venous oxygen saturation']",['mixed venous oxygen saturation (SvO 2 ) and jugular venous oxygen saturation'],"[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}]","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0020674', 'cui_str': 'Targeted Temperature Management'}, {'cui': 'C2711941', 'cui_str': 'SvO2 - Venous oxygen saturation'}]","[{'cui': 'C0428177', 'cui_str': 'Mixed venous oxygen saturation measurement'}, {'cui': 'C2711941', 'cui_str': 'SvO2 - Venous oxygen saturation'}]",,0.047735,The reduction in ΔSO 2 (v-jv) on day 3 was associated with high mortality in severe TBI patients.,"[{'ForeName': 'Naofumi', 'Initials': 'N', 'LastName': 'Bunya', 'Affiliation': 'Departments of Emergency Medicine, Sapporo Medical University, Hokkaido, Japan. Electronic address: naobun1221@gmail.com.'}, {'ForeName': 'Wakiko', 'Initials': 'W', 'LastName': 'Aisaka', 'Affiliation': 'Departments of Emergency Medicine, Sapporo Medical University, Hokkaido, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Miyata', 'Affiliation': 'Departments of Neurosurgery, Sapporo Medical University, Hokkaido, Japan.'}, {'ForeName': 'Eichi', 'Initials': 'E', 'LastName': 'Narimatsu', 'Affiliation': 'Departments of Emergency Medicine, Sapporo Medical University, Hokkaido, Japan.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Yamashita', 'Affiliation': 'Emergency and Critical Care Center, Tokuyama Central Hospital, Yamaguchi, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Kuroda', 'Affiliation': 'Department of Emergency Medicine, Kagawa University School of Medicine, Kagawa, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Kobata', 'Affiliation': 'Osaka Mishima Emergency Critical Care Center, Osaka, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Kaneko', 'Affiliation': 'Emergency and General Medicine, Kumamoto University Hospital, Kumamoto, Japan.'}, {'ForeName': 'Motoki', 'Initials': 'M', 'LastName': 'Fujita', 'Affiliation': 'Advanced Medical Emergency and Critical Care Center, Yamaguchi University Hospital, Yamaguchi, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Dohi', 'Affiliation': 'Department of Emergency Medicine, The Jikei University, Tokyo, Japan.'}, {'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Oda', 'Affiliation': 'Advanced Medical Emergency and Critical Care Center, Yamaguchi University Hospital, Yamaguchi, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Maekawa', 'Affiliation': 'Yamaguchi Prefectural Grand Medical Center, Yamaguchi, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",World neurosurgery,['10.1016/j.wneu.2020.01.004']
439,31958993,Initial Findings of a Multicomponent School Health Intervention in Rural Appalachia: The Greenbrier CHOICES Project.,"Background . Schools are an important setting for health promotion because they afford children and adolescents numerous opportunities to accumulate the recommended physical activity (PA) minutes and make other health-related decisions, including healthy eating. Unfortunately, there is little evidence of coordinated school-based health interventions in rural Appalachia. The Greenbrier Children's Health Opportunities Involving Coordinated Efforts in Schools Project was a federally funded, 3-year, multicomponent school-based health intervention focused on PA, healthy eating, and weight management.  Aims . The purpose of this study was to evaluate the impact of Greenbrier Children's Health Opportunities Involving Coordinated Efforts in Schools on adolescent PA, dietary behaviors, and weight status.  Method . Measures of PA, dietary behaviors, and body mass index were collected across 14 data points throughout the intervention (including a baseline in Year 1).  Results . Participants included 4,633 randomly selected middle school students ( M  = 2,289,  F  = 2,344) across the intervention. Baseline to Year 3 findings revealed a 12.8 percentage point increase in students achieving 60 minutes of daily PA. There were no significant differences in either dietary behavior or body mass index.  Discussion . Findings provide evidence of the positive impact comprehensive school-based health interventions can have on middle school student health-related behaviors.  Conclusion . Schools remain an ideal setting for health promotion. Initiatives targeting more than one level of influence on health-related behaviors are more likely to succeed.",2020,There were no significant differences in either dietary behavior or body mass index.  ,"['Rural Appalachia', 'Participants included 4,633 randomly selected middle school students ( M  = 2,289,  F  = 2,344) across the intervention']",['Multicomponent School Health Intervention'],"['PA, dietary behaviors, and body mass index', 'dietary behavior or body mass index']","[{'cui': 'C0003609', 'cui_str': 'Appalachia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",4633.0,0.019366,There were no significant differences in either dietary behavior or body mass index.  ,"[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Jones', 'Affiliation': 'Illinois State University, Normal, IL, USA.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Zuest', 'Affiliation': 'California State University Chico, Chico, CA, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Bulger', 'Affiliation': 'West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Eloise', 'Initials': 'E', 'LastName': 'Elliott', 'Affiliation': 'West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Kibum', 'Initials': 'K', 'LastName': 'Cho', 'Affiliation': 'Hanyang University, Seoul, South Korea.'}, {'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Lilly', 'Affiliation': 'West Virginia University, Morgantown, WV, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198119897612']
440,30819011,The Relationship Between School Dropout and Pregnancy Among Adolescent Girls and Young Women in South Africa: A HPTN 068 Analysis.,"Background . Prevention of both school dropout and teen pregnancy represent clear public health priorities for South Africa, yet their complex and potentially cyclical relationship has not been fully explored.  Objective . To further understand how this relationship operates, we analyzed data from a randomized trial of young women aged 13 to 20 years enrolled in school in rural South Africa to estimate the association between pregnancy and subsequent dropout and between dropout and subsequent pregnancy.  Method . We examined inverse probability (IP) of exposure-weighted survival curves for school dropout by pregnancy and for pregnancy by school dropout. We used weighted curves to calculate 1-, 2-, and 3-year risk differences and risk ratios. Additionally, we used an IP-weighted marginal structural cox model to estimate a hazard ratio (HR) for each relationship.  Results . Dropout from school was associated with subsequent pregnancy (HR 3.58; 95% confidence interval [CI] [2.04, 6.28]) and pregnancy was associated with subsequent school dropout (HR 2.36; 95% CI [1.29, 4.31]). Young women who attended school but attended fewer days had a higher hazard of pregnancy than those who attended more school (HR 3.64; 95% CI [2.27, 5.84]).  Conclusion . Pregnancy is both a cause and a consequence of school dropout. Consideration of school attendance and academic performance could ultimately enhance pregnancy prevention efforts in this population. Programs should be tailored differently for (1) girls who have dropped out of school, (2) those who are in school and at risk for pregnancy, and (3) those who are in school and become pregnant.",2019,"Dropout from school was associated with subsequent pregnancy (HR 3.58; 95% confidence interval [CI] [2.04, 6.28]) and pregnancy was associated with subsequent school dropout (HR 2.36; 95% CI [1.29, 4.31]).","['young women aged 13 to 20 years enrolled in school in rural South Africa to estimate the association between pregnancy and subsequent dropout and between dropout and subsequent pregnancy', '1) girls who have dropped out of school, (2) those who are in school and at risk for pregnancy, and (3) those who are in school and become pregnant', 'Adolescent Girls and Young Women in South Africa', 'Young women who attended school']",[],"['hazard of pregnancy', 'School Dropout and Pregnancy', '1-, 2-, and 3-year risk differences and risk ratios']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0557295', 'cui_str': 'Attending school (finding)'}]",[],"[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0038488', 'cui_str': 'School Dropouts'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",,0.0387198,"Dropout from school was associated with subsequent pregnancy (HR 3.58; 95% confidence interval [CI] [2.04, 6.28]) and pregnancy was associated with subsequent school dropout (HR 2.36; 95% CI [1.29, 4.31]).","[{'ForeName': 'Marie C D', 'Initials': 'MCD', 'LastName': 'Stoner', 'Affiliation': '1 University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Rucinski', 'Affiliation': '2 Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Jessie K', 'Initials': 'JK', 'LastName': 'Edwards', 'Affiliation': '1 University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Selin', 'Affiliation': '1 University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Hughes', 'Affiliation': '3 University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': '4 Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Yaw', 'Initials': 'Y', 'LastName': 'Agyei', 'Affiliation': '2 Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'F Xavier', 'Initials': 'FX', 'LastName': 'Gomez-Olive', 'Affiliation': '5 University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'MacPhail', 'Affiliation': '5 University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Kahn', 'Affiliation': '5 University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Pettifor', 'Affiliation': '1 University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198119831755']
441,30741001,Feeling Hopeful Motivates Change: Emotional Responses to Messages Communicating Comparative Risk of Electronic Cigarettes and Combusted Cigarettes.,"BACKGROUND


Emotions are important in smoking-related communications, but the role of discrete positive and negative emotions in comparative risk messages about combusted and electronic cigarettes (e-cigarettes) is unclear.
METHOD


In an online experiment, 1,202 U.S. adult current smokers or recent quitters were randomized to view one of six messages about comparative risk of e-cigarettes and cigarettes. Participants reported their feelings of hope, happiness, fear, guilt, disgust, and anger and risk perceptions and behavioral intentions about e-cigarettes and cigarettes.
RESULTS


Hope was associated with higher perceived absolute cigarette risk, lower perceived absolute and comparative e-cigarette risk, and stronger intentions to quit smoking, seek quit help, use nicotine replacement therapy (NRT), switch to e-cigarettes, and use e-cigarettes exclusively versus dual use. Happiness was related to stronger intentions to seek quit help, use NRT, and switch to e-cigarettes but higher perceived comparative risk of e-cigarettes. Fear was associated with stronger intentions to quit smoking, seek quit help, use NRT, and switch to e-cigarettes. Guilt was related to higher perceived absolute cigarette risk, lower perceived comparative e-cigarette risk, and stronger intentions to use NRT. Disgust was associated with higher absolute and comparative e-cigarette risk and stronger intentions to quit smoking, seek quit help, and use e-cigarettes exclusively versus dual use. Anger was related to lower perceived absolute cigarette risk, higher perceived comparative e-cigarette risk, and weaker intentions to quit smoking.
CONCLUSION


Comparative risk messages about e-cigarettes that arouse hope, fear, and guilt and avoid anger might be particularly likely to have positive impact on smokers.",2019,"Disgust was associated with higher absolute and comparative e-cigarette risk and stronger intentions to quit smoking, seek quit help, and use e-cigarettes exclusively versus dual use.","['1,202 U.S. adult current smokers or recent quitters']",['Electronic Cigarettes and Combusted Cigarettes'],"['absolute cigarette risk, higher perceived comparative e-cigarette risk, and weaker intentions to quit smoking', 'absolute cigarette risk, lower perceived absolute and comparative e-cigarette risk, and stronger intentions to quit smoking, seek quit help, use nicotine replacement therapy (NRT), switch to e-cigarettes', 'feelings of hope, happiness, fear, guilt, disgust, and anger and risk perceptions and behavioral intentions about e-cigarettes and cigarettes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3241966'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C1762617', 'cui_str': 'Weak (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C0683283', 'cui_str': 'Disgust'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",1202.0,0.0128636,"Disgust was associated with higher absolute and comparative e-cigarette risk and stronger intentions to quit smoking, seek quit help, and use e-cigarettes exclusively versus dual use.","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': '1 Georgia State University, Atlanta, GA, USA.'}, {'ForeName': 'Jiaying', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': '2 University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Popova', 'Affiliation': '1 Georgia State University, Atlanta, GA, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198118825236']
442,32056146,"Self-Monitoring and Management of Blood Pressure in Patients with Stroke or TIA: An Economic Evaluation of TEST-BP, A Randomised Controlled Trial.","BACKGROUND


Prevention of secondary stroke following initial ictus is an important focus of after-stroke care. Blood pressure (BP) is a key risk factor, so usual care following stroke or transient ischaemic attack includes regular BP checks and monitoring of anti-hypertensive medication. This is traditionally carried out in primary care, but the evidence supporting self-monitoring and self-guided management of BP in the general population with hypertension is growing.
OBJECTIVE


Our objective was to estimate the cost effectiveness of treatment as usual (TAU) versus (1) self-monitoring of BP (S-MON) and (2) self-monitoring and guided self-management of anti-hypertensive medication (S-MAN).
METHODS


This was a within-trial economic evaluation of a randomised controlled trial estimating the incremental cost per 1 mmHg BP reduction and per quality-adjusted life-year (QALY) gained over a 6-month time horizon from the perspective of the UK National Health Service (NHS).
RESULTS


Data were evaluable for 140 participants. Costs per patient were £473, £853 and £1035; mean reduction in systolic BP (SBP) was 3.6, 6.7 and 6.1 mmHg, and QALYs accrued were 0.427, 0.422 and 0.423 for TAU, S-MON and S-MAN, respectively. No statistically significant differences in incremental costs or outcomes were detected. On average, S-MAN was dominated or extended dominated. The incremental cost per 1 mmHg BP reduction from S-MON versus TAU was £137.
CONCLUSION


On average, S-MAN is an inefficient intervention. S-MON may be cost effective, depending on the willingness to pay for a 1 mmHg BP reduction, although it yielded fewer QALYs over the within-trial time horizon. Decision modelling is required to explore the longer-term costs and outcomes.",2020,"Costs per patient were £473, £853 and £1035; mean reduction in systolic BP (SBP) was 3.6, 6.7 and 6.1 mmHg, and QALYs accrued were 0.427, 0.422 and 0.423 for TAU, S-MON and S-MAN, respectively.","['Data were evaluable for 140 participants', 'Patients with Stroke or TIA']","['Self-Monitoring and Management of Blood Pressure', 'usual (TAU) versus (1) self-monitoring of BP (S-MON) and (2) self-monitoring and guided self-management of anti-hypertensive medication (S-MAN']","['incremental cost per 1\xa0mmHg BP reduction and per quality-adjusted life-year (QALY', 'Blood pressure (BP', 'systolic BP (SBP', 'incremental costs or outcomes']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}]","[{'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]",,0.107845,"Costs per patient were £473, £853 and £1035; mean reduction in systolic BP (SBP) was 3.6, 6.7 and 6.1 mmHg, and QALYs accrued were 0.427, 0.422 and 0.423 for TAU, S-MON and S-MAN, respectively.","[{'ForeName': 'Lois G', 'Initials': 'LG', 'LastName': 'Kim', 'Affiliation': 'Cambridge Centre for Health Services Research, Institute of Public Health, University of Cambridge School of Clinical Medicine, Forvie Site, Cambridge, UK.'}, {'ForeName': 'Edward C F', 'Initials': 'ECF', 'LastName': 'Wilson', 'Affiliation': 'Cambridge Centre for Health Services Research, Institute of Public Health, University of Cambridge School of Clinical Medicine, Forvie Site, Cambridge, UK. ed.wilson@uea.ac.uk.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Davison', 'Affiliation': 'Ageing and Stroke Medicine, Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Allan B', 'Initials': 'AB', 'LastName': 'Clark', 'Affiliation': 'Medical Statistics Group, Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Phyo K', 'Initials': 'PK', 'LastName': 'Myint', 'Affiliation': 'Ageing Clinical and Experimental Research (ACER), Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Potter', 'Affiliation': 'Ageing and Stroke Medicine, Norwich Medical School, University of East Anglia, Norwich, UK.'}]",PharmacoEconomics - open,['10.1007/s41669-020-00196-w']
443,31006941,Benefit finding among parents of young children with type 1 diabetes.,"Benefit finding, perceived positive effects of adversity, has been associated with psychological well-being in people with chronic illnesses and with better adherence for adolescents with type 1 diabetes (T1D). Our qualitative research with parents of young children (< 6 years old) with T1D indicated that benefit finding (BF) is a common parental coping mechanism, but no tools exist to measure BF in parents. We determined psychometric properties of the Diabetes Benefit Finding Scale for Parents (DBFS-P), a 16-item questionnaire adapted from the validated adolescent version. Parents of young children with T1D (n = 172) were participants in a randomized trial of an online intervention. We examined the DBFS-P factor structure through principal component analysis (PCA); internal consistency through Cronbach's alpha; convergent validity via bivariate correlations between the DBFS-P and measures of parental depression, anxiety, T1D self-efficacy, and hypoglycemia fear; and discriminant validity via bivariate correlations between the DBFS-P and measures of parental somatization and child behavior problems. PCA revealed one factor (56.47% variance) with Cronbach's α = 0.95. Convergent validity of the DBFS-P was supported by significant correlations with parental depression (r = -0.35, P < 0.001), anxiety (r = -0.20, P = 0.008), T1D self-efficacy (r = 0.36, P < 0.001), and hypoglycemia fear (r = 0.27, P < 0.001). Non-significant correlations with parental somatization (r = -0.06, P = 0.42) and child behavior problems (r = -0.12, P = 0.14) support its discriminant validity. The DBFS-P demonstrated good psychometric properties as a tool for assessing BF among caregivers.",2019,"Benefit finding, perceived positive effects of adversity, has been associated with psychological well-being in people with chronic illnesses and with better adherence for adolescents with type 1 diabetes (T1D).","['parents of young children (< 6\u2009years old) with T1D', 'Parents of young children with T1D (n\u2009=\u2009172', 'parents of young children with type 1 diabetes', 'adolescents with type 1 diabetes (T1D']",[],"['parental depression, anxiety, T1D self-efficacy, and hypoglycemia fear', 'parental depression', 'hypoglycemia fear ', 'parental somatization', 'child behavior problems', 'T1D self-efficacy', 'anxiety', 'parental somatization and child behavior problems']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],"[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",172.0,0.037939,"Benefit finding, perceived positive effects of adversity, has been associated with psychological well-being in people with chronic illnesses and with better adherence for adolescents with type 1 diabetes (T1D).","[{'ForeName': 'Jessica S', 'Initials': 'JS', 'LastName': 'Pierce', 'Affiliation': ""Center for Healthcare Delivery Science, Nemours Children's Hospital, Orlando, Florida.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Wasserman', 'Affiliation': ""Center for Healthcare Delivery Science, Nemours Children's Hospital, Orlando, Florida.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Enlow', 'Affiliation': 'Center for Healthcare Delivery Science, Nemours Alfred I. duPont Hospital for Children, Wilmington, Delaware.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Aroian', 'Affiliation': 'College of Nursing, University of Central Florida, Orlando, Florida.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Division of Pediatric Endocrinology, Child Health Evaluation and Research Unit, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Wysocki', 'Affiliation': ""Center for Healthcare Delivery Science, Nemours Children's Specialty Care, Jacksonville, Florida.""}]",Pediatric diabetes,['10.1111/pedi.12860']
444,31915308,"Randomised, double-blind, multicentre, mixed-methods, dose-escalation feasibility trial of mirtazapine for better treatment of severe breathlessness in advanced lung disease (BETTER-B feasibility).","New treatments are required for severe breathlessness in advanced disease. We conducted a randomised feasibility trial of mirtazapine over 28 days in adults with a modified medical research council breathlessness scale score ≥3. Sixty-four patients were randomised (409 screened), achieving our primary feasibility endpoint of recruitment. Most patients had COPD or interstitial lung disease; 52 (81%) completed the trial. There were no differences between placebo and mirtazapine in tolerability or safety, and blinding was maintained. Worst breathlessness ratings at day 28 (primary clinical activity endpoint) were, 7.1 (SD 2.3, placebo) and 6.3 (SD 1.8, mirtazapine). A phase III trial of mirtazapine is indicated. Trial registration: ISRCTN 32236160; European Clinical Trials Database (EudraCT no: 2015-004064-11).",2020,"There were no differences between placebo and mirtazapine in tolerability or safety, and blinding was maintained.","['adults with a modified medical research council breathlessness scale score ≥3', 'severe breathlessness in advanced lung disease']","['placebo', 'mirtazapine', 'EudraCT']","['tolerability or safety, and blinding', 'Worst breathlessness ratings']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3472510', 'cui_str': 'Medical Research Council breathlessness scale score'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0049506', 'cui_str': 'Mirtazapine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0429691', 'cui_str': 'Breathlessness rating (staging scale)'}]",64.0,0.7013,"There were no differences between placebo and mirtazapine in tolerability or safety, and blinding was maintained.","[{'ForeName': 'Irene J', 'Initials': 'IJ', 'LastName': 'Higginson', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, Kings College London and King's College Hospital NHS Foundation Trust, London, UK irene.higginson@kcl.ac.uk.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wilcock', 'Affiliation': 'Department of Clinical Oncology, University of Nottingham and Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Miriam J', 'Initials': 'MJ', 'LastName': 'Johnson', 'Affiliation': 'Wolfson Palliative Care Research Centre, Hull York Medical School, The University of Hull, Hull, UK.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Bajwah', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, Kings College London and King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Lovell', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, Kings College London and King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Deokhee', 'Initials': 'D', 'LastName': 'Yi', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, Kings College London and King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Hart', 'Affiliation': 'Respiratory Research Group, Hull York Medical School, University of Hull, Castle Hill Hospital, University of Hull, Hull, Kingston upon Hull, UK.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Crosby', 'Affiliation': 'Palliative Care, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Poad', 'Affiliation': 'Clinical Trials Research Unit (CTRU), University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Currow', 'Affiliation': 'Faculty of Heath, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Best', 'Affiliation': 'Clinical Trials Research Unit (CTRU), University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'Clinical Trials Research Unit (CTRU), University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Thorax,['10.1136/thoraxjnl-2019-213879']
445,32056311,"World Health Organization risk drinking level reductions are associated with improved functioning and are sustained among patients with mild, moderate and severe alcohol dependence in clinical trials in the United States and United Kingdom.","AIMS


To examine whether World Health Organization (WHO) risk-level reductions in drinking were achievable, associated with improved functioning and maintained over time among patients at varying initial alcohol dependence severity levels. Design and setting Secondary data analysis of multi-site randomized clinical trials: the US Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence (COMBINE) study and the UK Alcohol Treatment Trial (UKATT).
PARTICIPANTS


Individuals with alcohol dependence enrolled in COMBINE (n = 1383; 68.8% male) and seeking treatment for alcohol problems in UKATT (n = 742; 74.1% male). Interventions Naltrexone, acamprosate or placebo, and combined behavioral intervention or medication management in COMBINE. Social behavior network therapy or motivational enhancement therapy in UKATT.
MEASUREMENTS


WHO risk-level reductions were assessed via the calendar method. Alcohol dependence was measured by the Alcohol Dependence Scale, the Leeds Dependence Questionnaire and the Diagnostic and Statistical Manual of Mental Disorders. Measures of functioning included alcohol-related consequences (Drinker Inventory of Consequences and Alcohol Problems Questionnaire), mental health (Short Form Health Survey) and liver enzyme tests.
FINDINGS


One- and two-level reductions in WHO risk levels in the last month of treatment were maintained at the 1-year follow-up [adjusted odds ratio (OR), 95% confidence interval (CI) = one-level reduction in COMBINE: 3.51 (2.73, 4.29) and UKATT: 2.65 (2.32, 2.98)] and associated with fewer alcohol-related consequences [e.g. B, 95% CI = one-level reduction COMBINE: -26.22 (-30.62, -21.82)], better mental health [e.g. B, 95% CI = one-level reduction UKATT: 9.53 (7.36, 11.73)] and improvements in γ-glutamyltransferase [e.g. B, 95% CI = one-level reduction UKATT: -89.77 (-122.50, -57.04)] at the end of treatment, even among patients with severe alcohol dependence. Results were similar when abstainers were excluded. Conclusions Reductions in World Health Organization risk levels for alcohol consumption appear to be achievable, associated with better functioning and maintained over time in both the United States and the United Kingdom.",2020,"Results were similar when abstainers were excluded CONCLUSIONS: Reductions in World Health Organization risk levels for alcohol consumption appear to be achievable, associated with better functioning, and maintained over time in both the United States and the United Kingdom.",['Individuals with alcohol dependence enrolled in COMBINE (n=1383; 68.8% male) and seeking treatment for alcohol problems in UKATT (n=742; 74.1% male'],"['Social behavior network therapy or motivational enhancement therapy', 'Naltrexone, acamprosate, or placebo, and combined behavioral intervention or medication management']","['Alcohol dependence', 'functioning included alcohol-related consequences (Drinker Inventory of Consequences and Alcohol Problems Questionnaire), mental health (Short Form Health Survey), and liver enzyme tests', 'better mental health', 'Alcohol Dependence Scale, the Leeds Dependence Questionnaire, and the Diagnostic and Statistical Manual of Mental Disorders', 'WHO risk level reductions', 'WHO risk levels']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0549393', 'cui_str': 'Alcohol problem'}]","[{'cui': 'C0037397', 'cui_str': 'Social Behavior'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0284941', 'cui_str': 'acamprosate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}]","[{'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0549393', 'cui_str': 'Alcohol problem'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0450984', 'cui_str': 'Alcohol dependence scale (assessment scale)'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0432415,"Results were similar when abstainers were excluded CONCLUSIONS: Reductions in World Health Organization risk levels for alcohol consumption appear to be achievable, associated with better functioning, and maintained over time in both the United States and the United Kingdom.","[{'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Heather', 'Affiliation': 'Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Falk', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.'}, {'ForeName': 'Raye Z', 'Initials': 'RZ', 'LastName': 'Litten', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.'}, {'ForeName': 'Deborah S', 'Initials': 'DS', 'LastName': 'Hasin', 'Affiliation': 'Department of Epidemiology, Columbia University, New York, NY, USA.'}, {'ForeName': 'Henry R', 'Initials': 'HR', 'LastName': 'Kranzler', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Karl F', 'Initials': 'KF', 'LastName': 'Mann', 'Affiliation': 'Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Raymond F', 'Initials': 'RF', 'LastName': 'Anton', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15011']
446,31676719,Delivery of long-term-injectable agents for TB by lay carers: pragmatic randomised trial.,"BACKGROUND


People with recurrent or drug-resistant TB require long courses of intramuscular injections. We evaluate a novel system in which patient-nominated lay carers were trained to deliver intramuscular injections to patients in their own homes.
METHODS


A pragmatic, individually randomised non-inferiority trial was conducted at two hospitals in Malawi. Adults starting TB retreatment were recruited. Patients randomised to the intervention received home-based care from patient-nominated lay people trained to deliver intramuscular streptomycin. Patients receiving standard care were admitted to hospital for 2 months of streptomycin. The primary outcome was successful treatment (alive and on treatment) at the end of the intervention.
RESULTS


Of 456 patients screened, 204 participants were randomised. The trial was terminated early due to futility. At the end of the intervention, 97/101 (96.0%) in the hospital arm were still alive and on treatment compared with 96/103 (93.2%) in the home-based arm (risk difference -0.03 (95% CI -0.09 to 0.03); p value 0.538). There were no differences in the proportion completing 8 months of anti-TB treatment; or the proportion experiencing 2-month sputum culture conversion. The mean cost of hospital-based management was US$1546.3 per person, compared to US$729.2 for home-based management. Home-based care reduced risk of catastrophic household costs by 84%.
CONCLUSIONS


Although this trial failed to meet target recruitment, the available data demonstrate that training patient-nominated lay people has potential to provide a feasible solution to the operational challenges associated with delivering long-term-injectable drugs to people with recurrent or drug-resistant TB in resource-limited settings, and substantially reduce costs. Further data under operational conditions are required.
TRIAL REGISTRATION NUMBER


ISRCTN05815615.",2020,"The mean cost of hospital-based management was US$1546.3 per person, compared to US$729.2 for home-based management.","['TB by lay carers', 'People with recurrent or drug-resistant TB require long courses of intramuscular injections', 'Patients receiving standard care were admitted to hospital for 2\u2009months of streptomycin', '456 patients screened, 204 participants were randomised', 'patient-nominated lay carers', 'two hospitals in Malawi', 'Adults starting TB retreatment were recruited']",['home-based care from patient-nominated lay people trained to deliver intramuscular streptomycin'],"['successful treatment (alive and on treatment', 'mean cost of hospital-based management']","[{'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0038425', 'cui_str': 'Streptomycin'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0038425', 'cui_str': 'Streptomycin'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",204.0,0.212781,"The mean cost of hospital-based management was US$1546.3 per person, compared to US$729.2 for home-based management.","[{'ForeName': 'Danielle B', 'Initials': 'DB', 'LastName': 'Cohen', 'Affiliation': 'Infection, Immunity & Cardiovascular Disease, University of Sheffield, Sheffield, UK Danielle.Cohen@sheffield.ac.uk.'}, {'ForeName': 'Kuzani', 'Initials': 'K', 'LastName': 'Mbendera', 'Affiliation': 'Malawi National TB Programme, Lilongwe, Malawi.'}, {'ForeName': 'Hendramoorthy', 'Initials': 'H', 'LastName': 'Maheswaran', 'Affiliation': 'Clinical Department, Malawi Liverpool Wellcome Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Mavuto', 'Initials': 'M', 'LastName': 'Mukaka', 'Affiliation': 'Clinical Department, Malawi Liverpool Wellcome Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Mangochi', 'Affiliation': 'Clinical Department, Malawi Liverpool Wellcome Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Linna', 'Initials': 'L', 'LastName': 'Phiri', 'Affiliation': 'Clinical Department, Malawi Liverpool Wellcome Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Madan', 'Affiliation': 'Division of Health Sciences, University of Warwick, Warwick, UK.'}, {'ForeName': 'Geraint', 'Initials': 'G', 'LastName': 'Davies', 'Affiliation': 'Clinical Department, Malawi Liverpool Wellcome Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Corbett', 'Affiliation': 'Clinical Department, Malawi Liverpool Wellcome Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Bertel', 'Initials': 'B', 'LastName': 'Squire', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}]",Thorax,['10.1136/thoraxjnl-2018-212675']
447,32005336,Examining Hope as a Transdiagnostic Mechanism of Change Across Anxiety Disorders and CBT Treatment Protocols.,"Hope is a trait that represents the capacity to identify strategies or pathways to achieve goals and the motivation or agency to effectively pursue those pathways. Hope has been demonstrated to be a robust source of resilience to anxiety and stress and there is limited evidence that, as has been suggested for decades, hope may function as a core process or transdiagnostic mechanism of change in psychotherapy. The current study examined the role of hope in predicting recovery in a clinical trial in which 223 individuals with 1 of 4 anxiety disorders were randomized to transdiagnostic cognitive behavior therapy (CBT), disorder-specific CBT, or a waitlist controlled condition. Effect size results indicated moderate to large intraindividual increases in hope, that changes in hope were consistent across the five CBT treatment protocols, that changes in hope were significantly greater in CBT relative to waitlist, and that changes in hope began early in treatment. Results of growth curve analyses indicated that CBT was a robust predictor of trajectories of change in hope compared to waitlist, and that changes in hope predicted changes in both self-reported and clinician-rated anxiety. Finally, a statistically significant indirect effect was found indicating that the effects of treatment on changes in anxiety were mediated by treatment effects on hope. Together, these results suggest that hope may be a promising transdiagnostic mechanism of change that is relevant across anxiety disorders and treatment protocols.",2020,"Effect size results indicated moderate to large intraindividual increases in hope, that changes in hope were consistent across the five CBT treatment protocols, that changes in hope were significantly greater in CBT relative to waitlist, and that changes in hope began early in treatment.",['223 individuals with 1 of 4 anxiety disorders'],"['transdiagnostic cognitive behavior therapy (CBT), disorder-specific CBT', 'CBT']",['changes in anxiety'],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",223.0,0.0222165,"Effect size results indicated moderate to large intraindividual increases in hope, that changes in hope were consistent across the five CBT treatment protocols, that changes in hope were significantly greater in CBT relative to waitlist, and that changes in hope began early in treatment.","[{'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Gallagher', 'Affiliation': 'University of Houston. Electronic address: mwgallagher@uh.edu.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Long', 'Affiliation': 'University of Houston.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Richardson', 'Affiliation': 'University of Houston.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': ""D'Souza"", 'Affiliation': 'University of Houston.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Boswell', 'Affiliation': 'University at Albany, SUNY.'}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Farchione', 'Affiliation': 'Boston University.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Barlow', 'Affiliation': 'Boston University.'}]",Behavior therapy,['10.1016/j.beth.2019.06.001']
448,31777008,Cost-Effectiveness of Sertraline in Primary Care According to Initial Severity and Duration of Depressive Symptoms: Findings from the PANDA RCT.,"BACKGROUND


Antidepressants are commonly prescribed for depression, but it is unclear whether treatment efficacy depends on severity and duration of symptoms and how prescribing might be targeted cost-effectively.
OBJECTIVES


We investigated the cost-effectiveness of the antidepressant sertraline compared with placebo in subgroups defined by severity and duration of depressive symptoms.
METHODS


We undertook a cost-effectiveness analysis from the perspective of the NHS and Personal and Social Services (PSS) in the UK alongside the PANDA (What are the indications for Prescribing ANtiDepressants that will leAd to a clinical benefit?) randomised controlled trial (RCT), which compared sertraline with placebo over a 12-week period. Quality of life data were collected at baseline and at 2, 6, and 12 weeks post-randomisation using EQ-5D-5L, from which we calculated quality-adjusted life years (QALYs). Costs (in 2017/18£) were collected using patient records and from resource use questionnaires administered at each follow-up interval. Differences in mean costs and mean QALYs and net monetary benefits were estimated. Our primary analysis used net monetary benefit regressions to identify any interaction between the cost-effectiveness of sertraline and subgroups defined by baseline symptom severity (0-11; 12-19; 20+ on the Clinical Interview Schedule-Revised) and, separately, duration of symptoms (greater or less than 2 years duration). A secondary analysis estimated the cost-effectiveness of sertraline versus placebo, irrespective of duration or severity.
RESULTS


There was no evidence of an association between the baseline severity of depressive symptoms and the cost-effectiveness of sertraline. Compared to patients with low symptom severity, the expected net benefits in patients with moderate symptoms were £24 (95% CI - £280 to £328; p value 0.876) and the expected net benefits in patients with high symptom severity were £37 (95% CI - £221 to £296; p value 0.776). Patients who had a longer history of depressive symptoms at baseline had lower expected net benefits from sertraline than those with a shorter history; however, the difference was uncertain (- £27 [95% CI - £258 to £204]; p value 0.817). In the secondary analysis, patients treated with sertraline had higher expected net benefits (£122 [95% CI £18 to £226]; p value 0.101) than those in the placebo group. Sertraline had a high probability (> 95%) of being cost-effective if the health system was willing to pay at least £20,000 per QALY gained.
CONCLUSIONS


We found insufficient evidence of a prespecified threshold based on severity or symptom duration that GPs could use to target prescribing to a subgroup of patients where sertraline is most cost-effective. Sertraline is probably a cost-effective treatment for depressive symptoms in UK primary care.
TRIAL REGISTRATION


Controlled Trials ISRCTN Registry, ISRCTN84544741.",2020,There was no evidence of an association between the baseline severity of depressive symptoms and the cost-effectiveness of sertraline.,['Primary Care'],"['Sertraline', 'sertraline with placebo', 'NHS and Personal and Social Services (PSS', 'placebo', 'sertraline versus placebo', 'sertraline', 'PANDA', 'antidepressant sertraline']","['Quality of life data', 'Cost-Effectiveness', 'net benefits', 'longer history of depressive symptoms', 'duration or severity', 'mean costs and mean QALYs and net monetary benefits', 'cost-effectiveness']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0037440', 'cui_str': 'Social Welfare'}, {'cui': 'C2931429', 'cui_str': 'Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}]","[{'cui': 'C0034380'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",,0.267615,There was no evidence of an association between the baseline severity of depressive symptoms and the cost-effectiveness of sertraline.,"[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hollingworth', 'Affiliation': 'Bristol Medical School, University of Bristol, 5 Tyndall Avenue, Bristol, BS8 1UD, UK. william.hollingworth@bristol.ac.uk.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Fawsitt', 'Affiliation': 'Health Information and Quality Authority, City Gate, Mahon, Cork, Ireland.'}, {'ForeName': 'Padraig', 'Initials': 'P', 'LastName': 'Dixon', 'Affiliation': 'Bristol Medical School, University of Bristol, 5 Tyndall Avenue, Bristol, BS8 1UD, UK.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Duffy', 'Affiliation': 'Division of Psychiatry, University College London, 6th Floor Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Araya', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, Kings' College London, Denmark Hill, London, SE5 8AF, UK.""}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Peters', 'Affiliation': 'Bristol Medical School, University of Bristol, 5 Tyndall Avenue, Bristol, BS8 1UD, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Thom', 'Affiliation': 'Bristol Medical School, University of Bristol, 5 Tyndall Avenue, Bristol, BS8 1UD, UK.'}, {'ForeName': 'Nicky J', 'Initials': 'NJ', 'LastName': 'Welton', 'Affiliation': 'Bristol Medical School, University of Bristol, 5 Tyndall Avenue, Bristol, BS8 1UD, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Wiles', 'Affiliation': 'Bristol Medical School, University of Bristol, 5 Tyndall Avenue, Bristol, BS8 1UD, UK.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Lewis', 'Affiliation': 'Division of Psychiatry, University College London, 6th Floor Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PharmacoEconomics - open,['10.1007/s41669-019-00188-5']
449,31481365,"Comparative evaluation of minimally invasive 'tibial tuberoplasty' surgical technique versus conventional open surgery for Schatzker II-III tibial plateau fractures: design of a multicentre, randomised, controlled and blinded trial (TUBERIMPACT study).","INTRODUCTION


Fractures of the tibial plateau are in constant progression. They affect an elderly population suffering from a number of comorbidities, but also a young population increasingly practicing high-risk sports. The conventional open surgical technique used for tibial plateau fractures has several pitfalls: bone and skin devascularisation, increased risks of infection and functional rehabilitation difficulties. Since 2011, Poitiers University Hospital is offering to its patients a new minimally invasive technique for the reduction and stabilisation of tibial plateau fractures, named 'tibial tuberoplasty'. This technique involves expansion of the tibial plateau through inflation using a kyphoplasty balloon, filling of the fracture cavity with cement and percutaneous screw fixation. We designed a study to evaluate the quality of fracture reduction offered by percutaneous tuberoplasty versus conventional open surgery for tibial plateau fracture and its impact on clinical outcome.
METHODS AND ANALYSIS


This is a multicentre randomised controlled trial comparing two surgical techniques in the treatment of tibial plateau fractures. 140 patients with a Schatzker II or III tibial plateau fracture will be recruited in France. They will be randomised either in tibial tuberoplasty arm or in conventional surgery arm. The primary outcome is the postoperative radiological step-off reduction blindly measured on CT scan (within 48 hours post-op). Additional outcomes include other radiological endpoints, pain, functional abilities, quality of life assessment and health-economic endpoints. Outcomes assessment will be performed at baseline (before surgery), at day 0 (surgery), at 2, 21, 45 days, 3, 6, 12 and 24 months postsurgery.
ETHICS AND DISSEMINATION


This study has been approved by the ethics committee Ile-De-France X and will be conducted in accordance with current Good Clinical Practice (GCP) guidelines, Declaration of Helsinki and standard operating procedures. The results will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


Clinicaltrial.gov:NCT03444779.",2019,"We designed a study to evaluate the quality of fracture reduction offered by percutaneous tuberoplasty versus conventional open surgery for tibial plateau fracture and its impact on clinical outcome.
","['Schatzker II-III tibial plateau fractures', '140 patients with a Schatzker II or III tibial plateau fracture will be recruited in France', 'tibial plateau fractures']","['percutaneous screw fixation', ""minimally invasive 'tibial tuberoplasty' surgical technique versus conventional open surgery"", 'percutaneous tuberoplasty versus conventional open surgery']","['postoperative radiological step-off reduction blindly measured on CT scan', 'radiological endpoints, pain, functional abilities, quality of life assessment and health-economic endpoints']","[{'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0584640', 'cui_str': 'Tibial plateau structure (body structure)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0348025', 'cui_str': 'Open approach - access (qualifier value)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0231627', 'cui_str': 'Step-off (finding)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0034380'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013557', 'cui_str': 'economics'}]",140.0,0.101133,"We designed a study to evaluate the quality of fracture reduction offered by percutaneous tuberoplasty versus conventional open surgery for tibial plateau fracture and its impact on clinical outcome.
","[{'ForeName': 'Tanguy', 'Initials': 'T', 'LastName': 'Vendeuvre', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Centre Hospitalier Universitaire de Poitiers, Poitiers, France tanguy.vendeuvre@chu-poitiers.fr.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Monlezun', 'Affiliation': 'Prismatics Lab, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Brandet', 'Affiliation': 'Prismatics Lab, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Ingrand', 'Affiliation': 'UFR Medecine et Pharmacie, Universite de Poitiers, Poitiers, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Durand-Zaleski', 'Affiliation': 'URCEco Ile de France, AP-HP, Hôtel-Dieu Hospital, Paris, France.'}, {'ForeName': 'Louis-Etienne', 'Initials': 'LE', 'LastName': 'Gayet', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Germaneau', 'Affiliation': 'Institut Pprime, Futuroscope, Poitou-Charentes, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Khiami', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Hopitaux Universitaires Pitie Salpetriere-Charles Foix, Paris, France.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Roulaud', 'Affiliation': 'Prismatics Lab, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Herpe', 'Affiliation': 'Department of Radiology, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Rigoard', 'Affiliation': 'Prismatics Lab, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.'}]",BMJ open,['10.1136/bmjopen-2018-026962']
450,31300507,Timing Of Primary Surgery for cleft palate (TOPS): protocol for a randomised trial of palate surgery at 6 months versus 12 months of age.,"INTRODUCTION


Cleft palate is among the most common birth abnormalities. The success of primary surgery in the early months of life is crucial for successful feeding, speech, hearing, dental development and facial growth. Over recent decades, age at palatal surgery in infancy has reduced. This has led to palatal closure in one-stage procedures being carried out around the age of 12 months, but in some cases as early as 6 months. The primary objective of the Timing Of Primary Surgery for Cleft Palate (TOPS)trial is to determine whether surgery for cleft palate performed at 6 or 12 months of age is most beneficial for speech outcomes.
METHODS AND ANALYSIS


Infants with a diagnosis of non-syndromic isolated cleft palate will be randomised to receive standardised primary surgery (Sommerlad technique) for closure of the cleft at either 6 months or 12 months, corrected for gestational age. The primary outcome will be perceived insufficient velopharyngeal function at 5 years of age. Secondary outcomes measured across 12 months, 3 years and 5 years will include growth, safety of the procedure, dentofacial development, speech, hearing level and middle ear function. Video and audio recordings of speech will be collected in a standardised age-appropriate manner and analysed independently by multiple speech and language therapists. The trial aims to recruit and follow-up 300 participants per arm. Data will be analysed according to the intention-to-treat principle using a 5% significance level. All analyses will be prespecified within a full and detailed statistical analysis plan.
ETHICS AND DISSEMINATION


Ethical approval has been sought in each participating country according to country-specific procedures. Trial results will be presented at conferences, published in peer-reviewed journals and disseminated through relevant patient support groups.
TRIAL REGISTRATION NUMBER


NCT00993551; Pre-results.",2019,"The success of primary surgery in the early months of life is crucial for successful feeding, speech, hearing, dental development and facial growth.","['Cleft Palate', 'Infants with a diagnosis of non-syndromic isolated cleft palate', 'cleft palate (TOPS']",['standardised primary surgery (Sommerlad technique'],"['successful feeding, speech, hearing, dental development and facial growth', 'growth, safety of the procedure, dentofacial development, speech, hearing level and middle ear function', 'insufficient velopharyngeal function']","[{'cui': 'C0008925', 'cui_str': 'Cleft Palate'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1837218'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0457585', 'cui_str': 'Middle ear function (observable entity)'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0031843', 'cui_str': 'function'}]",300.0,0.174624,"The success of primary surgery in the early months of life is crucial for successful feeding, speech, hearing, dental development and facial growth.","[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Shaw', 'Affiliation': 'School of Medical Sciences, Division of Dentistry, The University of Manchester, Manchester, Greater Manchester, UK.'}, {'ForeName': 'Gunvor', 'Initials': 'G', 'LastName': 'Semb', 'Affiliation': 'School of Medical Sciences, Division of Dentistry, The University of Manchester, Manchester, Greater Manchester, UK.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Lohmander', 'Affiliation': 'Functional Area Speech and Language Pathology, Division of Speech and Language Pathology, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Persson', 'Affiliation': 'Institute of Neuroscience and Physiology, Speech and Language Pathology Unit, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Willadsen', 'Affiliation': 'Department of Nordic Studies and Linguistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Clayton-Smith', 'Affiliation': ""Division of Evolution and Genomic Sciences and Manchester Centre for Genomic Medicine, Manchester University NHS Foundation Trust, St Mary's Hospital, Manchester, Greater Manchester, UK.""}, {'ForeName': 'Inge Kiemle', 'Initials': 'IK', 'LastName': 'Trindade', 'Affiliation': 'Hospital de Reabilitação de Anomalias Craniofaciais Universidade de São Paulo, 5Facu Faculdade de Odontologia de Bauru, Bauru-SP, Brazil.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Munro', 'Affiliation': 'Manchester Centre for Audiology and Deafness, School of Health Sciences, The University of Manchester, Manchester, Greater Manchester, UK.'}, {'ForeName': 'Carrol', 'Initials': 'C', 'LastName': 'Gamble', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Harman', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Conroy', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Weichart', 'Affiliation': 'School of Medical Sciences, Division of Dentistry, The University of Manchester, Manchester, Greater Manchester, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Williamson', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}]",BMJ open,['10.1136/bmjopen-2019-029780']
451,32146571,Urinary carbohydrate antigen 19-9 level as a biomarker in children with acute pyelonephritis.,"Early and prompt diagnosis of pyelonephritis is of great importance in children. The aim of this study is to evaluate the diagnostic accuracy of urinary carbohydrate antigen 19-9 (CA19-9) levels for predicting acute pyelonephritis (APN) in children with urinary tract infection (UTI). Patients were allocated into two groups of APN and acute cystitis according to their diagnosis. Urine samples of all patients were collected. Also, complete history was taken, and physical examination, kidney and bladder ultrasonography,  99m Tc-dimercaptosuccinic acid renal cortical scintigraphy, and urine analysis and culture were performed. Urinary CA19-9 was measured by an electrochemiluminescence enzyme immunometric kit. In addition, CA19-9 levels were measured in the APN group 2 weeks and 3 months later. A total of 100 children were included in this study (mean age 46 ± 31 months, 16 males and 84 females). CA19-9 levels were significantly greater in the APN group than acute cystitis group (510 ± 328 vs. 18.7 ± 18.6 U/ml, P < 0.001). During follow-up periods of the APN group, CA19-9 levels decreased to 180 ± 124 U/ml after 2 weeks (P < 0.001) and 30 ± 23 U/ml after 3 months (P < 0.001). Urinary CA-19-9 had 95.3% sensitivity and 80% specificity for the diagnosis of APN. The area under the curve value of CA19-9 was 0.904 (95% CI 0.831-0.977).Conclusion: Urinary CA19-9 level can be used as a reliable biomarker for early detection of APN prior to urine culture confirmation in children with UTI. What is known: • Early and prompt diagnosis of pyelonephritis is necessary in children to prevent renal damage. • Acute pyelonephritis can present with vague and nonspecific symptoms in infants and children. What is new: • Urinary carbohydrate antigen 19-9 is a reliable biomarker for early detection of acute pyelonephritis prior to urine culture confirmation. • Urinary carbohydrate antigen 19-9 has 95.3% sensitivity and 80% specificity for diagnosis of acute pyelonephritis.",2020,Urinary carbohydrate antigen 19-9 has 95.3% sensitivity and 80% specificity for diagnosis of acute pyelonephritis.,"['children with urinary tract infection (UTI', 'children with acute pyelonephritis', '100 children were included in this study (mean age 46\u2009±\u200931\xa0months, 16 males and 84 females', 'children']",['urinary carbohydrate antigen 19-9 (CA19-9) levels'],"['physical examination, kidney and bladder ultrasonography,  99m Tc-dimercaptosuccinic acid renal cortical scintigraphy, and urine analysis and culture', 'Urinary CA19-9', 'CA19-9 levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0520575', 'cui_str': 'Acute pyelonephritis (disorder)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0201551', 'cui_str': 'CA 199 measurement'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0075928', 'cui_str': 'Technetium-99m-DMSA'}, {'cui': 'C0034606', 'cui_str': 'Gamma Camera Imaging'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",100.0,0.03699,Urinary carbohydrate antigen 19-9 has 95.3% sensitivity and 80% specificity for diagnosis of acute pyelonephritis.,"[{'ForeName': 'Abdol-Mohammad', 'Initials': 'AM', 'LastName': 'Kajbafzadeh', 'Affiliation': ""Pediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Tehran University of Medical Sciences, 62, Dr. Qarib's St, Keshavarz Blvd, Tehran, 14194 33151, Iran. kajbafzd@sina.tums.ac.ir.""}, {'ForeName': 'Seyedeh Sanam', 'Initials': 'SS', 'LastName': 'Ladi Seyedian', 'Affiliation': ""Pediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Tehran University of Medical Sciences, 62, Dr. Qarib's St, Keshavarz Blvd, Tehran, 14194 33151, Iran.""}, {'ForeName': 'Seyedeh Maryam', 'Initials': 'SM', 'LastName': 'Kameli', 'Affiliation': ""Pediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Tehran University of Medical Sciences, 62, Dr. Qarib's St, Keshavarz Blvd, Tehran, 14194 33151, Iran.""}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Nabavizadeh', 'Affiliation': ""Pediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Tehran University of Medical Sciences, 62, Dr. Qarib's St, Keshavarz Blvd, Tehran, 14194 33151, Iran.""}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Boroomand', 'Affiliation': ""Pediatric Nephrology Department, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mastaneh', 'Initials': 'M', 'LastName': 'Moghtaderi', 'Affiliation': ""Pediatric Nephrology Department, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.""}]",European journal of pediatrics,['10.1007/s00431-020-03626-3']
452,32146127,Molecular lymph node staging for bladder cancer patients undergoing radical cystectomy with pelvic lymph node dissection.,"OBJECTIVE


Presence of lymph node (LN) metastasis in bladder cancer (BCa) is a main risk factor for tumor recurrence after radical cystectomy (RC). Molecular analysis facilitates detection of small-volume LN metastases with higher sensitivity than standard histopathology. The aim of the present study was to establish molecular LN analysis in BCa patients undergoing RC with lymph node dissection (LND) and to determine its ability to predict tumor recurrence.
PATIENTS AND METHODS


Five transcripts with overexpression in BCa (FXYD3, KRT17, KRT20, SPINK1, UPKII) were evaluated for molecular LN analysis. We included 76 BCa patients from the prospective, randomized surgical phase-III trial (LEA AUO AB 25/02, NCT01215071) investigating extended vs. limited LND at RC. The primary endpoint was recurrence-free survival (RFS). As control, 136 LNs from 45 patients without BCa were analyzed to determine a threshold for pathologic gene expression.
RESULTS


About 1,319 LNs were investigated with molecular and histopathologic examination. Histopathology detected 39 LN metastases in 17 (22%) patients. Of the tested genes FXYD3 performed best and classified all pN+-patients correctly as node-positive (pN+/molN+). In addition, FXYD3 reclassified 43 histopathologic negative LNs and 7 (9%) pN0-patients as molecular node-positive (pN0/molN+). Molecular and histopathologic LN status (pN0/molN0 vs. pN0/molN+ vs. pN+/molN+) was significantly associated with locally advanced disease (P = 0.006) and poor RFS (P < 0.001). Median RFS was not reached in LN-negative patients (pN0/molN0), 45 months (95%CI 8-83) in exclusively molecular positive patients (pN0/molN+) and 9 months (95%CI 5-13) in patients with histopathologic and molecular positive LNs (pN+/molN+).
CONCLUSIONS


Molecular LN analysis with FXYD3 identified additional LN metastases in histopathologic negative LNs and identified patients with elevated risk of tumor recurrence after RC. Thus, molecular LN analysis improves LN staging and might serve as a tool to guide adjuvant treatment.",2020,Of the tested genes FXYD3 performed best and classified all pN+-patients correctly as node-positive (pN+/molN+).,"['45 patients without BCa', '76 BCa patients', 'BCa patients undergoing RC with lymph node dissection (LND', 'bladder cancer patients undergoing radical cystectomy with pelvic lymph node dissection', 'bladder cancer (BCa']","['pN0/molN+ vs. pN+/molN', 'radical cystectomy (RC']","['Median RFS', 'locally advanced disease', 'recurrence-free survival (RFS', 'poor RFS', 'Molecular and histopathologic LN status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242382', 'cui_str': 'Lymph Node Dissection'}, {'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}, {'cui': 'C0729595', 'cui_str': 'Pelvic lymph node structure (body structure)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}]","[{'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",76.0,0.129531,Of the tested genes FXYD3 performed best and classified all pN+-patients correctly as node-positive (pN+/molN+).,"[{'ForeName': 'Matthias M', 'Initials': 'MM', 'LastName': 'Heck', 'Affiliation': 'Technical University of Munich, School of Medicine, Rechts der Isar Medical Center, Department of Urology, Munich, Germany. Electronic address: Matthias.Heck@tum.de.'}, {'ForeName': 'Florestan J', 'Initials': 'FJ', 'LastName': 'Koll', 'Affiliation': 'Technical University of Munich, School of Medicine, Rechts der Isar Medical Center, Department of Urology, Munich, Germany.'}, {'ForeName': 'Margitta', 'Initials': 'M', 'LastName': 'Retz', 'Affiliation': 'Technical University of Munich, School of Medicine, Rechts der Isar Medical Center, Department of Urology, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Autenrieth', 'Affiliation': 'Technical University of Munich, School of Medicine, Rechts der Isar Medical Center, Department of Urology, Munich, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Magg', 'Affiliation': 'Technical University of Munich, School of Medicine, Rechts der Isar Medical Center, Department of Urology, Munich, Germany.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Lunger', 'Affiliation': 'Technical University of Munich, School of Medicine, Rechts der Isar Medical Center, Department of Urology, Munich, Germany.'}, {'ForeName': 'Jürgen E', 'Initials': 'JE', 'LastName': 'Gschwend', 'Affiliation': 'Technical University of Munich, School of Medicine, Rechts der Isar Medical Center, Department of Urology, Munich, Germany.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Nawroth', 'Affiliation': 'Technical University of Munich, School of Medicine, Rechts der Isar Medical Center, Department of Urology, Munich, Germany.'}]",Urologic oncology,['10.1016/j.urolonc.2020.01.018']
453,31345981,Study protocol for developing #CuttingCRC: a barbershop-based trial on masculinity barriers to care and colorectal cancer screening uptake among African-American men using an exploratory sequential mixed-methods design.,"INTRODUCTION


Colorectal cancer (CRC) is preventable, as screening leads to the identification and removal of precancerous polyps. African-American men consistently have the highest CRC mortality rates, and their CRC-screening uptake remains low for complex reasons. Culture-specific masculinity barriers to care may contribute to the low uptake among African-American men. Examining these barriers to care is vital as CRC screening may challenge cultural role expectations of African-American men, whose tendency is to delay help-seeking medical care. Barbershops provide a pathway for reaching African-American men with masculinity barriers to care who are not regularly receiving healthcare services and CRC screening. This study aims to develop and pilot test a theory-driven, culture-specific, barbershop-based intervention targeting masculinity barriers to care and CRC-screening uptake among African-American men ages 45-75.
METHODS AND ANALYSIS


Guided by the theory of planned behaviour and the behaviour change wheel, we will use a multistage mixed-methods study design, beginning with an exploratory sequential approach to validate items for subsequent use in a pilot mixed-methods intervention. First, we will collect and analyse qualitative data from focus groups, cognitive interviews and expert item review to validate and test a culture-specific Masculinity Barriers to Care Scale (MBCS) among African-American men. Next, we will administer the MBCS to our target population as an online quantitative survey and evaluate the association between scores and CRC-screening uptake. Then, we will consider existing evidence-based approaches, our integrated results (qualitative +quantitative), and community input to design a culture-specific, behavioural intervention aimed at increasing CRC-screening uptake among African-American men and feasible for barbershop delivery. We will test the peer intervention in a pilot study with a two-arm cluster randomised design (six barbershops, randomised by site) to reduce contamination and account for barbershop culture differences. Our primary outcomes for the pilot are recruitment, sample size estimation, preliminary efficacy and acceptability.
ETHICS AND DISSEMINATION


Ethics approval was obtained from the University of Utah Institutional Review Board (00113679), who will also be responsible for receiving communication updates regarding important protocol modifications. To ensure confidentiality, data dispersed to project team members will be blinded of any identifying participant information. Study results will be disseminated through publications in peer-reviewed journals, community dialogue sessions, and presentations at conferences.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov identifier: NCT03733197 (Pre-results);https://clinicaltrials.gov/ct2/show/NCT03733197.",2019,"African-American men consistently have the highest CRC mortality rates, and their CRC-screening uptake remains low for complex reasons.","['African-American men and feasible for barbershop delivery', 'African-American men ages 45-75', 'African-American men']","['theory-driven, culture-specific, barbershop-based intervention targeting masculinity barriers to care and CRC-screening uptake', 'culture-specific Masculinity Barriers to Care Scale (MBCS']","['efficacy and acceptability', 'highest CRC mortality rates']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0042757', 'cui_str': 'Masculinity'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0222045'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",,0.040476,"African-American men consistently have the highest CRC mortality rates, and their CRC-screening uptake remains low for complex reasons.","[{'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Rogers', 'Affiliation': 'Family & Preventive Medicine, University of Utah School of Medicine, Salt Lake City, Utah, USA.'}, {'ForeName': 'Kola', 'Initials': 'K', 'LastName': 'Okuyemi', 'Affiliation': 'Family & Preventive Medicine, University of Utah School of Medicine, Salt Lake City, Utah, USA.'}, {'ForeName': 'Electra D', 'Initials': 'ED', 'LastName': 'Paskett', 'Affiliation': 'Internal Medicine, College of Medicine, Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Roland J', 'Initials': 'RJ', 'LastName': 'Thorpe', 'Affiliation': ""Program for Research on Men's Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.""}, {'ForeName': 'Tiana N', 'Initials': 'TN', 'LastName': 'Rogers', 'Affiliation': 'Sorenson Impact Center, University of Utah Eccles School of Business, Salt Lake City, Utah, USA.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Hung', 'Affiliation': 'College of Dental Medicine, Roseman University of Health Sciences, South Jordan, Utah, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Zickmund', 'Affiliation': 'Internal Medicine, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Riley', 'Affiliation': 'Family & Preventive Medicine, University of Utah School of Medicine, Salt Lake City, Utah, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Fetters', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}]",BMJ open,['10.1136/bmjopen-2019-030000']
454,31434765,"Protocol for an outcome assessor-blinded pilot randomised controlled trial of an ion-exchange water softener for the prevention of atopic eczema in neonates, with an embedded mechanistic study: the Softened Water for Eczema Prevention (SOFTER) trial.","INTRODUCTION


Atopic eczema affects 20% of UK children, and environmental factors are important in its aetiology. Several observational studies suggest an increased risk of atopic eczema in children living in hard water areas. The Softened Water for Eczema Prevention pilot trial tests the feasibility of installing domestic ion-exchange water softeners around the time of birth to reduce the risk of atopic eczema in children with a family history of atopy. A further aim is to explore the pathophysiological mechanisms for this in an embedded mechanistic study.
METHODS AND ANALYSIS


Multicentre parallel group assessor-blinded randomised controlled pilot trial. Participants are newborn babies (n=80) living in a hard water (>250 mg/L calcium carbonate) area at risk of developing atopic eczema because of a family history of atopy. Participants will be randomised prior to birth in a 1:1 ratio. The intervention group will have an ion-exchange water softener installed prior to birth. The control group will receive their usual domestic hard water supply. Follow-up will be until 6 months of age. Data will be collected at birth (baseline), 1, 3 and 6 months of age. The main outcome is the proportion of eligible families screened who are willing and able to be randomised. Several secondary feasibility and clinical endpoints will also be evaluated, alongside mechanistic outcomes. Data will be analysed on an intention-to-treat basis. There will be no hypothesis testing for the clinical outcomes. Study acceptability will be evaluated through semistructured interviews.
ETHICS AND DISSEMINATION


This study has been reviewed and given a favourable opinion by the North West-Liverpool East Research Ethics Committee (Ref: 17/NW/0661). The results of the study will be reported at international conferences and in peer-reviewed scientific journals. We will send participating families a summary of the pilot trial results.
TRIAL REGISTRATION NUMBER


NCT03270566.",2019,The Softened Water for Eczema Prevention pilot trial tests the feasibility of installing domestic ion-exchange water softeners around the time of birth to reduce the risk of atopic eczema in children with a family history of atopy.,"['children with a family history of atopy', 'children living in hard water areas', 'Participants are newborn babies (n=80) living in a hard water (>250\u2009mg/L calcium carbonate) area at risk of developing atopic eczema because of a family history of atopy', 'atopic eczema in neonates, with an embedded mechanistic study: the Softened Water for Eczema Prevention (SOFTER) trial']","['installing domestic ion-exchange water softeners', 'ion-exchange water softener']",['risk of atopic eczema'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0241889', 'cui_str': 'Family Medical History'}, {'cui': 'C0392707', 'cui_str': 'Atopy (disorder)'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439268', 'cui_str': 'microgram/mL'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0022013', 'cui_str': 'Ion Exchange'}, {'cui': 'C0043047', 'cui_str': 'Water'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}]",,0.223414,The Softened Water for Eczema Prevention pilot trial tests the feasibility of installing domestic ion-exchange water softeners around the time of birth to reduce the risk of atopic eczema in children with a family history of atopy.,"[{'ForeName': 'Zarif K', 'Initials': 'ZK', 'LastName': 'Jabbar-Lopez', 'Affiliation': ""Unit for Population-Based Dermatology Research, St John's Institute of Dermatology, King's College London and Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Nikeeta', 'Initials': 'N', 'LastName': 'Gurung', 'Affiliation': ""Unit for Population-Based Dermatology Research, St John's Institute of Dermatology, King's College London and Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Greenblatt', 'Affiliation': ""Unit for Population-Based Dermatology Research, St John's Institute of Dermatology, King's College London and Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Briley', 'Affiliation': ""Women's Health, King's College London, London, UK.""}, {'ForeName': 'Joanne R', 'Initials': 'JR', 'LastName': 'Chalmers', 'Affiliation': 'Centre of Evidence-Based Dermatology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Kim Suzanne', 'Initials': 'KS', 'LastName': 'Thomas', 'Affiliation': 'Centre of Evidence-Based Dermatology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Frost', 'Affiliation': 'Aqua Focus, Shrewsbury, UK.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Kezic', 'Affiliation': 'Coronel Institute of Occupational Health, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'John E A', 'Initials': 'JEA', 'LastName': 'Common', 'Affiliation': 'Skin Research Institute of Singapore, A*STAR, Singapore, Singapore.'}, {'ForeName': 'Heidi H', 'Initials': 'HH', 'LastName': 'Kong', 'Affiliation': 'Dermatology Branch, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Segre', 'Affiliation': 'Translational and Functional Genomics Branch, National Human Genome Research Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Danby', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Diseases, University of Sheffield Medical School, Sheffield, UK.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Cork', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Diseases, University of Sheffield Medical School, Sheffield, UK.'}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Peacock', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Flohr', 'Affiliation': ""Unit for Population-Based Dermatology Research, St John's Institute of Dermatology, King's College London and Guy's and St Thomas' NHS Foundation Trust, London, UK carsten.flohr@kcl.ac.uk.""}]",BMJ open,['10.1136/bmjopen-2018-027168']
455,31242065,"Mechanisms and perceived mental health changes after a livelihood intervention for HIV-positive Kenyans: Longitudinal, qualitative findings.","While food insecurity and poverty worsen mental health outcomes among people living with HIV/AIDS (PLHIV), few intervention studies have targeted poverty and food insecurity as a way to improve mental health. Among HIV-positive patients, addressing such upstream determinants may prove crucial to ensure better mental health and HIV clinical outcomes. We integrated longitudinal, qualitative research into a randomized trial of a livelihood intervention to understand processes and mechanisms for how the intervention may affect mental health among HIV-infected Kenyan adults. In-depth interviews were conducted with intervention participants ( n  = 45) and control participants ( n  = 9) at two time-points (after intervention start and upon intervention end). Interviews ( n  = 85) were translated, double-coded, and analyzed thematically using an inductive-deductive team approach. Participants reported numerous mental health improvements post-intervention including reduced stress, fewer symptoms of anxiety, improved mood, lower depressive symptoms, fewer repetitive and ruminating thoughts, and more hopefulness for the future. Improvements in mental health appear to occur via several mechanisms including: 1) better food security and income; 2) increased physical activity and ability to create fruitful routines around farm work; and, 3) improved sense of self as an active member of the community. Qualitative, longitudinal interviews may help identify intervention mechanisms for improved mental health, but additional research is required to confirm self-reports of mental health changes. These findings suggest that livelihood interventions may improve mental health in multi-faceted ways, and help PLHIV better integrate with their communities.  Trial registered  at ClinicalTrials.gov: NCT01548599.",2020,"Participants reported numerous mental health improvements post-intervention including reduced stress, fewer symptoms of anxiety, improved mood, lower depressive symptoms, fewer repetitive and ruminating thoughts, and more hopefulness for the future.","['people living with HIV/AIDS (PLHIV', 'HIV-infected Kenyan adults', 'Interviews ( n \u2009']","['livelihood interventions', 'livelihood intervention']","['physical activity and ability to create fruitful routines around farm work; and, 3) improved sense of self', 'mental health', 'reduced stress, fewer symptoms of anxiety, improved mood, lower depressive symptoms, fewer repetitive and ruminating thoughts']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0337839', 'cui_str': 'Kenyans (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0557759', 'cui_str': 'Farmland'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C4319827', 'cui_str': 'Thought'}]",85.0,0.122443,"Participants reported numerous mental health improvements post-intervention including reduced stress, fewer symptoms of anxiety, improved mood, lower depressive symptoms, fewer repetitive and ruminating thoughts, and more hopefulness for the future.","[{'ForeName': 'Abigail M', 'Initials': 'AM', 'LastName': 'Hatcher', 'Affiliation': 'University of California and University of the Witwatersrand.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Lemus Hufstedler', 'Affiliation': 'University of California.'}, {'ForeName': 'Kathryne', 'Initials': 'K', 'LastName': 'Doria', 'Affiliation': 'Yale University.'}, {'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Dworkin', 'Affiliation': 'University of Washington.'}, {'ForeName': 'Elly', 'Initials': 'E', 'LastName': 'Weke', 'Affiliation': 'Kenya Medical Research Institute.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Conroy', 'Affiliation': 'University of California.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Bukusi', 'Affiliation': 'Kenya Medical Research Institute and University of Washington.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Cohen', 'Affiliation': 'University of California.'}, {'ForeName': 'Sheri D', 'Initials': 'SD', 'LastName': 'Weiser', 'Affiliation': 'University of California.'}]",Transcultural psychiatry,['10.1177/1363461519858446']
456,31965548,"Food Effect on a Single High Dose of Carotegrast Methyl, an Oral Antagonist of α4-Integrin, in Healthy Male Subjects: A Randomised, Placebo-Controlled, Double-Blind Study.","BACKGROUND AND OBJECTIVES


Carotegrast methyl, a novel prodrug, oral antagonist of α4-integrin, is in development for the treatment of active ulcerative colitis. This randomised, placebo-controlled, double-blind, crossover study evaluated the effect of food on the pharmacokinetics and pharmacodynamics as well as the safety profile after a single dose of carotegrast methyl in healthy male subjects.
METHODS


Subjects were randomised to receive a single dose of carotegrast methyl (240, 480 or 960 mg) or placebo in a 6:2 ratio and received the study drug under both fed and fasted conditions separated by an 8-day washout. The pharmacokinetic profiles of carotegrast methyl and its active metabolite, carotegrast, were assessed. The pharmacodynamic profile was evaluated according to a change in the peripheral lymphocyte count. Safety was monitored throughout.
RESULTS


Based on the area under the time curve from zero to the time of the last quantifiable concentration (AUC last ), food reduced systemic exposure to both carotegrast methyl and carotegrast by 21-57% and 5-29%, respectively. The fed-to-fasted ratio of least square means for the increase in the lymphocyte count was almost at unity in each dose, indicating no food effect on pharmacodynamics. The time  ≥ 90% of maximum effect was prolonged dose dependently, suggesting that a 960 mg-dose can provide a long-lasting effect. Reported adverse events were all mild.
CONCLUSIONS


Despite the reduced systemic exposure to both carotegrast methyl and carotegrast, food had no effect on the increase in lymphocyte count. A single administration of carotegrast methyl up to 960 mg was found to be safe.",2020,"The fed-to-fasted ratio of least square means for the increase in the lymphocyte count was almost at unity in each dose, indicating no food effect on pharmacodynamics.","['healthy male subjects', 'Healthy Male Subjects', 'Subjects', 'active ulcerative colitis']","['Placebo', 'placebo', 'carotegrast methyl', 'Carotegrast Methyl, an Oral Antagonist of α4-Integrin']","['adverse events', 'lymphocyte count', 'Safety', 'peripheral lymphocyte count']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0021701', 'cui_str': 'Integrins'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte Number'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}]",,0.287147,"The fed-to-fasted ratio of least square means for the increase in the lymphocyte count was almost at unity in each dose, indicating no food effect on pharmacodynamics.","[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Fukase', 'Affiliation': 'CPC Clinic, Medipolis Medical Research Institute, Kagoshima, Japan. hiroyuki.fukase@crht.jp.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Kajioka', 'Affiliation': 'Clinical Development Department, EA Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Oikawa', 'Affiliation': 'Clinical Development Department, EA Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Ikeda', 'Affiliation': 'Clinical Development Department, EA Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Furuie', 'Affiliation': 'Emilio Moriguchi Clinic, Tokyo, Japan.'}]",Clinical drug investigation,['10.1007/s40261-019-00879-1']
457,30679522,Effects of circadian misalignment on cognition in chronic shift workers.,"Shift work is associated with increased human operational errors, presumably due to the circadian timing system that inhibits optimal cognitive function during the night. Circadian misalignment, which is the misalignment between the circadian pacemaker and behavioral/environmental cycles, impairs cognitive performance in non-shift workers. However, it remains uncertain whether the adverse cognitive consequences of circadian misalignment are also observed in chronic shift workers. Thus, we investigated the effects of circadian misalignment on cognitive performance in chronic shift workers. Using a randomized, cross-over design that simulated day shift work (circadian alignment) and night shift work (circadian misalignment), we show that circadian misalignment increases cognitive vulnerability on sustained attention, information processing and visual-motor performance, particularly after more than 10 hours of scheduled wakefulness. Furthermore, their increased levels of subjective sleepiness and their decreased sleep efficiency were significantly associated with impaired sustained attention and visual-motor performance. Our data suggest that circadian misalignment dramatically deteriorates cognitive performance in chronic shift workers under circadian misalignment. This increased cognitive vulnerability may have important safety consequences, given the increasing number of nighttime jobs that crucially rely on the availability of cognitive resources.",2019,"Furthermore, their increased levels of subjective sleepiness and their decreased sleep efficiency were significantly associated with impaired sustained attention and visual-motor performance.",['chronic shift workers'],"['simulated day shift work (circadian alignment) and night shift work (circadian misalignment', 'circadian misalignment']","['sustained attention and visual-motor performance', 'sleep efficiency', 'cognitive vulnerability on sustained attention, information processing and visual-motor performance', 'levels of subjective sleepiness', 'cognitive performance']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0425104', 'cui_str': 'Shift worker (finding)'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C4505093', 'cui_str': 'Night Shift Work'}, {'cui': 'C1275957', 'cui_str': 'Misalignment'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}]",,0.0184974,"Furthermore, their increased levels of subjective sleepiness and their decreased sleep efficiency were significantly associated with impaired sustained attention and visual-motor performance.","[{'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Chellappa', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, 02115, USA. schellappa@bwh.harvard.edu.""}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Morris', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, 02115, USA.""}, {'ForeName': 'Frank A J L', 'Initials': 'FAJL', 'LastName': 'Scheer', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, 02115, USA. fscheer@bwh.harvard.edu.""}]",Scientific reports,['10.1038/s41598-018-36762-w']
458,30552249,VA Telederm  study: protocol for a stepped-wedge cluster randomised trial to compare access to care for a mobile app versus a workstation-based store-and-forward teledermatology process.,"INTRODUCTION


Teledermatology has emerged as an important strategy to enhance access to high-quality skin care.  VA Telederm  is a provider-facing, web-based mobile app designed to integrate into the existing teledermatology workflow in the US Veterans Health Administration (VHA). In this study, we will conduct a systematic evaluation of  VA Telederm  on access outcomes in VHA facilities using a pragmatic trial guided by clinical and operational leaders.
METHODS AND ANALYSIS


The study is a prospective, stepped-wedge cluster randomised trial with cross-sectional exposure and outcome measurement via retrospective database analysis of administrative records. Each cluster is a VHA facility deemed eligible for the trial. We assign the intervention using a cluster-level balanced randomisation scheme based on facility size, baseline teledermatology uptake and geographic location. The trial will test whether patients receiving dermatological care at participating facilities will have better access compared with patients receiving care through the current standard process. The primary outcomes proxy for patient-level access to dermatology services, including (1) consult completion time for teledermatology consults; (2) appointment completion time for new dermatology consults; and (3) travel distance for dermatology services. As secondary outcomes, we will assess facility-level adoption outcomes, that is, the number of dermatology encounters and the proportion of teledermatology consults out of all dermatology encounters. To account for secular trends in outcomes and for correlation across individuals within clusters, we will assess the impact of the intervention using generalised linear mixed regression models.
DISCUSSION


Streamlining the current practice for store-and-forward teledermatology in the VHA can improve access to expert dermatological care for US veterans. The lessons learnt in this trial could validate the use of mobile technology for consultative store-and-forward dermatology in a large healthcare organisation. The results may also be of interest to other medical specialties assessing the merits of implementing mobile telehealth.
PROTOCOL VERSION


Version 3; 7 November 2018.
TRIAL REGISTRATION NUMBER


NCT03241589; Pre-results.",2018,"The primary outcomes proxy for patient-level access to dermatology services, including (1) consult completion time for teledermatology consults; (2) appointment completion time for new dermatology consults; and (3) travel distance for dermatology services.","['VERSION\n\n\nVersion 3; 7 November 2018', 'patients receiving dermatological care at participating facilities']",['mobile app versus a workstation-based store-and-forward teledermatology process'],"['number of dermatology encounters and the proportion of teledermatology consults out of all dermatology encounters', 'patient-level access to dermatology services, including (1) consult completion time for teledermatology consults; (2) appointment completion time for new dermatology consults; and (3) travel distance for dermatology services', 'facility-level adoption outcomes']","[{'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011625', 'cui_str': 'Agent, Dermatological'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C1736830', 'cui_str': 'Workstation (physical object)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0587579', 'cui_str': 'Dermatology service'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0040802', 'cui_str': 'Travel (event)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}]",,0.1174,"The primary outcomes proxy for patient-level access to dermatology services, including (1) consult completion time for teledermatology consults; (2) appointment completion time for new dermatology consults; and (3) travel distance for dermatology services.","[{'ForeName': 'Nicolae', 'Initials': 'N', 'LastName': 'Done', 'Affiliation': 'US Department of Veterans Affairs, Center for Access Policy, Evaluation and Research, Boston, Massachusetts, USA.'}, {'ForeName': 'Dennis H', 'Initials': 'DH', 'LastName': 'Oh', 'Affiliation': 'Department of Research and Development, San Francisco Veterans Affairs Health Care System, San Francisco, California, USA.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Weinstock', 'Affiliation': 'Center for Dermatoepidemiology, Providence Veterans Affairs Medical Center, Providence, Rhode Island, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Whited', 'Affiliation': 'Durham Veterans Affairs Medical Centre, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'George L', 'Initials': 'GL', 'LastName': 'Jackson', 'Affiliation': 'Division of General Internal Medicine, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'King', 'Affiliation': 'Division of General Internal Medicine, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Sara B', 'Initials': 'SB', 'LastName': 'Peracca', 'Affiliation': 'Department of Research and Development, San Francisco Veterans Affairs Health Care System, San Francisco, California, USA.'}, {'ForeName': 'A Rani', 'Initials': 'AR', 'LastName': 'Elwy', 'Affiliation': 'Department of Psychiatry and Human Behavior, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Prentice', 'Affiliation': 'US Department of Veterans Affairs, Center for Access Policy, Evaluation and Research, Boston, Massachusetts, USA.'}]",BMJ open,['10.1136/bmjopen-2018-022218']
459,30756527,"Study of effects of ifenprodil in patients with methamphetamine dependence: Protocol for an exploratory, randomized, double-blind, placebo-controlled trial.","AIMS


Pharmacotherapy for methamphetamine dependence has not yet been developed in Japan or elsewhere in the world. Ifenprodil is a blocker of G protein-activated inwardly rectifying potassium channels that play a key role in the mechanism of action of addictive substances. Our aim is to examine the safety, efficacy, and outcomes of ifenprodil for the treatment of methamphetamine dependence in a randomized, double-blind, placebo-controlled trial.
METHODS


The recruitment of outpatients with methamphetamine dependence began in January 2018. The patients will be randomized into three arms: placebo, 60 mg/d ifenprodil, or 120 mg/d ifenprodil. Placebo or ifenprodil will be taken for 84 days. We will use Cerocral fine granule 4% ®  (ifenprodil tartrate). Follow-up assessments will be conducted for 84 d after the drug administration period. All of the patients will be assessed by self-administered questionnaires and urine tests. The primary outcome will be the presence or absence of methamphetamine use during the 84-day administration period in the 120 mg/d ifenprodil and placebo groups. Secondary outcomes will include the number of days and percentage of days of abstinence from methamphetamine use, positive urine for methamphetamine, relapse risk, and drug craving.
DISCUSSION


This study is the first clinical trial of ifenprodil treatment for methamphetamine dependence and is designed as an intervention test with off-label drug use. The present study is expected to provide evidence of the effects of ifenprodil treatment on methamphetamine dependence.
TRIAL REGISTRY


This trial was registered in the UMIN clinical trial registry (UMIN000030849; date of registration: January 17, 2018).",2019,"Secondary outcomes will include the number of days and percentage of days of abstinence from methamphetamine use, positive urine for methamphetamine, relapse risk, and drug craving.
","['patients with methamphetamine dependence', 'outpatients with methamphetamine dependence began in January 2018']","['placebo', 'Cerocral fine granule 4% ®  (ifenprodil tartrate', 'ifenprodil', 'Placebo', 'placebo, 60\xa0mg/d ifenprodil, or 120\xa0mg/d ifenprodil']","['presence or absence of methamphetamine use', 'number of days and percentage of days of abstinence from methamphetamine use, positive urine for methamphetamine, relapse risk, and drug craving']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1533217', 'cui_str': 'Methamphetamine dependence (disorder)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C3853573', 'cui_str': 'Granules'}, {'cui': 'C0952164', 'cui_str': 'ifenprodil tartrate'}, {'cui': 'C0063340', 'cui_str': 'ifenprodil'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0556446', 'cui_str': 'Craves for drugs (finding)'}]",,0.617886,"Secondary outcomes will include the number of days and percentage of days of abstinence from methamphetamine use, positive urine for methamphetamine, relapse risk, and drug craving.
","[{'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Kotajima-Murakami', 'Affiliation': 'Department of Drug Dependence Research, National Institute of Mental Health, National Center of Neurology and Psychiatry, Tokyo, Japan.'}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Takano', 'Affiliation': 'Department of Drug Dependence Research, National Institute of Mental Health, National Center of Neurology and Psychiatry, Tokyo, Japan.'}, {'ForeName': 'Yasukazu', 'Initials': 'Y', 'LastName': 'Ogai', 'Affiliation': 'Social Psychiatry and Mental Health, Faculty of Medicine, University of Tsukuba, Tsukuba-shi, Ibaraki, Japan.'}, {'ForeName': 'Shotaro', 'Initials': 'S', 'LastName': 'Tsukamoto', 'Affiliation': 'Addictive Substance Project, Tokyo Metropolitan Institute of Medical Science, Tokyo, Japan.'}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Murakami', 'Affiliation': 'Department of Psychiatry, National Center Hospital, National Center of Neurology and Psychiatry, Kodaira-shi, Tokyo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Funada', 'Affiliation': 'Department of Psychiatry, National Center Hospital, National Center of Neurology and Psychiatry, Kodaira-shi, Tokyo, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Tanibuchi', 'Affiliation': 'Department of Psychiatry, Chiba Hospital, Funabashi-shi, Chiba, Japan.'}, {'ForeName': 'Hisateru', 'Initials': 'H', 'LastName': 'Tachimori', 'Affiliation': 'Department of Clinical Research Promotion, Translational Medical Center, National Center of Neurology and Psychiatry, Kodaira-shi, Tokyo, Japan.'}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Maruo', 'Affiliation': 'Department of Biostatistics, Faculty of Medicine, University of Tsukuba, Tsukuba-shi, Ibaraki, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Sasaki', 'Affiliation': 'Department of Child Psychiatry, Chiba-University Hospital, Chuo-ku, Chiba, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Drug Dependence Research, National Institute of Mental Health, National Center of Neurology and Psychiatry, Tokyo, Japan.'}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Ikeda', 'Affiliation': 'Department of Drug Dependence Research, National Institute of Mental Health, National Center of Neurology and Psychiatry, Tokyo, Japan.'}]",Neuropsychopharmacology reports,['10.1002/npr2.12050']
460,30657439,Associations between causal attributions for obesity and long-term weight loss.,"Obesity is a complex disease caused by a wide array of behavioral, biological, and environmental factors. However, obesity is often attributed to oversimplified and stigmatizing causal factors such as laziness, lack of willpower, and failure to take personal responsibility for one's health. Understanding of the causal factors that contribute to obesity  among people with obesity  may affect their weight management efforts. The current study explored associations between causal attributions for obesity and long-term weight loss, as well as examined potential changes in attributions with weight reduction. The 16-item Causal Attributions for Obesity scale (rated 1-7) was administered to 178 patients seeking behavioral/pharmacological weight-loss treatment. Causal attributions and weight were assessed at baseline, after 14 weeks of a low-calorie diet, and again at weeks 24 and 52 of a subsequent randomized trial (i.e., 66 weeks total). Logistic and linear regression examined effects of baseline causal attribution ratings on weight loss. Higher baseline ratings of personal responsibility attributions predicted 38% reduced odds of achieving ≥10% weight loss at week 52 ( p  = 0.02). Causal attribution ratings did not change over time or correlate continuously with weight change. Thus, attributing obesity to a failure of personal responsibility may impair long-term weight management efforts for individuals seeking ≥10% weight loss. Targeted techniques are needed to reduce patients' stigmatizing beliefs about the causes of obesity.",2020,Higher baseline ratings of personal responsibility attributions predicted 38% reduced odds of achieving ≥10% weight loss at week 52 (p = 0.02).,['178 patients seeking behavioral/pharmacological weight-loss treatment'],[],"['Causal attributions and weight', 'weight loss', 'Causal attribution ratings', '16-item Causal Attributions for Obesity scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],"[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0222045'}]",178.0,0.0131796,Higher baseline ratings of personal responsibility attributions predicted 38% reduced odds of achieving ≥10% weight loss at week 52 (p = 0.02).,"[{'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Pearl', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Alamuddin', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Berkowitz', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Walsh', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Kelly C', 'Initials': 'KC', 'LastName': 'Allison', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Jena Shaw', 'Initials': 'JS', 'LastName': 'Tronieri', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.'}]","Behavioral medicine (Washington, D.C.)",['10.1080/08964289.2018.1556202']
461,30403772,Metabolic Effects of Breaking Prolonged Sitting With Standing or Light Walking in Older South Asians and White Europeans: A Randomized Acute Study.,"BACKGROUND


Prolonged sitting is common in older adults and is associated with insulin resistance and poor cardiometabolic health. We investigate whether breaking prolonged sitting with regular short bouts of standing or light walking improves postprandial metabolism in older white European and South Asian adults and whether effects are modified by ethnic group.
METHODS


Thirty South Asian (15 women) and 30 white European (14 women) older adults (aged 65-79 years) undertook three experimental conditions in random order. (a) Prolonged sitting: continuous sitting during an observation period if 7.5 hours consuming two standardized mixed meals. (b) Standing breaks: sitting interrupted with 5 minutes of standing every 30 minutes (accumulating 60 minutes of standing over the observation period). (c) Walking breaks: sitting interrupted with 5 minutes of self-paced light walking every 30 minutes (accumulating 60 minutes of walking). Blood samples (glucose, insulin, triglycerides) and blood pressure were sampled regularly throughout each condition.
RESULTS


Compared with prolonged sitting, walking breaks lowered postprandial insulin by 16.3 mU/L, (95% CI: 19.7, 22.0) with greater reductions (p = .029) seen in South Asians (22.4 mU/L; 12.4, 32.4) than white Europeans (10.3 mU/L; 5.9, 14.7). Glucose (0.3 mmol/L; 0.1, 0.5) and blood pressure (4 mm Hg; 2, 6), but not triglycerides, were lower with walking breaks, with no ethnic differences. Standing breaks did not improve any outcome.
CONCLUSIONS


Breaking prolonged sitting with short bouts of light walking, but not standing, resulted in clinically meaningful improvements in markers of metabolic health in older adults, with South Asians gaining a greater reduction in postprandial insulin.
TRIAL REGISTRATION


NCT02453204.",2020,"Compared with prolonged sitting, walking breaks lowered postprandial insulin by 16.3 mU/l, (95% CI 19.7, 22.0) with greater reductions (p = 0.029) seen in South Asians (22.4 mU/l; 12.4, 32.4) than White Europeans (10.3 mU/l; 5.9, 14.7).","['Methods\n\n\nThirty South Asian (15 women) and 30 white European (14 women', 'older white European and South Asian adults', 'older adults', 'older adults (65-79 years) undertook three experimental conditions in random order', 'older South Asians and White Europeans']","['breaking prolonged sitting with standing or light walking', 'Walking Breaks: sitting interrupted with 5 mins of self-paced light walking every 30 mins (accumulating 60 mins of walking', 'Prolonged sitting', 'breaking prolonged sitting with regular short bouts of standing or light walking']","['postprandial insulin', 'postprandial metabolism', 'Blood samples (glucose, insulin, triglycerides) and blood pressure', 'blood pressure']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0443239', 'cui_str': 'Interrupted (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",30.0,0.0605649,"Compared with prolonged sitting, walking breaks lowered postprandial insulin by 16.3 mU/l, (95% CI 19.7, 22.0) with greater reductions (p = 0.029) seen in South Asians (22.4 mU/l; 12.4, 32.4) than White Europeans (10.3 mU/l; 5.9, 14.7).","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yates', 'Affiliation': 'Diabetes Research Centre, College of Life Sciences, University of Leicester, Australia.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Edwardson', 'Affiliation': 'Diabetes Research Centre, College of Life Sciences, University of Leicester, Australia.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Celis-Morales', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Australia.'}, {'ForeName': 'Stuart J H', 'Initials': 'SJH', 'LastName': 'Biddle', 'Affiliation': 'Institute for Resilient Regions, University of Southern Queensland, Springfield Central, Australia.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Bodicoat', 'Affiliation': 'Diabetes Research Centre, College of Life Sciences, University of Leicester, Australia.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, College of Life Sciences, University of Leicester, Australia.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Esliger', 'Affiliation': 'School of Sport, Exercise, and Health Sciences, Loughborough University, Birmingham.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Henson', 'Affiliation': 'Diabetes Research Centre, College of Life Sciences, University of Leicester, Australia.'}, {'ForeName': 'Aadil', 'Initials': 'A', 'LastName': 'Kazi', 'Affiliation': 'Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Diabetes Frail Ltd and University of Aston, Birmingham.'}, {'ForeName': 'Kamesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, College of Life Sciences, University of Leicester, Australia.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Australia.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Sinclair', 'Affiliation': 'Foundation for Diabetes Research in Older People, Diabetes Frail Ltd and University of Aston, Birmingham.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Rowlands', 'Affiliation': 'Diabetes Research Centre, College of Life Sciences, University of Leicester, Australia.'}, {'ForeName': 'Latha', 'Initials': 'L', 'LastName': 'Velayudhan', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London.""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Zaccardi', 'Affiliation': 'Diabetes Research Centre, College of Life Sciences, University of Leicester, Australia.'}, {'ForeName': 'Jason M R', 'Initials': 'JMR', 'LastName': 'Gill', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Australia.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/gly252']
462,32143221,Effects of Modified Constraint-Induced Movement Therapy in Real-World Arm Use in Young Children with Unilateral Cerebral Palsy: A Single-Blind Randomized Trial.,"OBJECTIVE


To determine whether modified constraint-induced movement therapy (mCIMT) with continuous restraint is feasible and effective in improving the use of the paretic arm in the real world among infants and toddlers with unilateral cerebral palsy (CP).
DESIGN


Single-blind randomized controlled trial.
SETTING


Tertiary hospital.
PARTICIPANTS


Children aged 7 to 36 months with unilateral CP ( N  = 24; 16 boys, 8 girls).
INTERVENTION


The experimental group received 2-hour clinic-based mCIMT sessions (5 days per week for 3 weeks), and a continuous restraint was applied.
MAIN OUTCOME MEASURES


Standardized assessments were conducted. Peabody Developmental Motor Scales-2 (PDMS-2), Gross Motor Function Measure-66, Pediatric Motor Activity Log (PMAL), and Pediatric Evaluation of Disability Inventory were measured pre- and postintervention. Children who agreed to participate in the accelerometer study additionally wore accelerometers on both their wrists for 3 days before and after the intervention.
RESULTS


The mCIMT group exhibited greater improvement in PMAL-how often ( p  = 0.048; ηp 2  = 0.173), PMAL-how well ( p  = 0.008; ηp 2  = 0.289), and PDMS-2 visual motor integration ( p  = 0.014; ηp 2  = 0.256) posttreatment than the control group. The percentage of time in moderate-to-vigorous physical activity ( z  = -2.24;  p  = 0.03) and vector magnitude average counts ( z  = -2.52;  p  = 0.01) significantly increased in children in who wore accelerometers ( N  = 8) after the 3-week mCIMT protocol.
CONCLUSION


mCIMT with continuous restraint applied to infants and toddlers with unilateral CP appeared to have a positive effect on paretic hand use in the real world.
CLINICAL TRIAL REGISTRATION NUMBER


NCT03418519.",2020,"The percentage of time in moderate-to-vigorous physical activity ( z  = -2.24;  p  = 0.03) and vector magnitude average counts ( z  = -2.52;  p  = 0.01) significantly increased in children in who wore accelerometers ( N  = 8) after the 3-week mCIMT protocol.
","['Young Children with Unilateral Cerebral Palsy', 'infants and toddlers with unilateral cerebral palsy (CP', 'Children aged 7 to 36 months with unilateral CP ( N \u2009=\u200924; 16 boys, 8 girls', 'Tertiary hospital']","['Modified Constraint-Induced Movement Therapy', '2-hour clinic-based mCIMT sessions', 'modified constraint-induced movement therapy (mCIMT) with continuous restraint', 'mCIMT with continuous restraint']","['percentage of time in moderate-to-vigorous physical activity', 'PMAL', 'Peabody Developmental Motor Scales-2 (PDMS-2), Gross Motor Function Measure-66', 'PDMS-2 visual motor integration', 'Pediatric Motor Activity Log (PMAL), and Pediatric Evaluation of Disability Inventory']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy (regime/therapy)'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",,0.0791907,"The percentage of time in moderate-to-vigorous physical activity ( z  = -2.24;  p  = 0.03) and vector magnitude average counts ( z  = -2.52;  p  = 0.01) significantly increased in children in who wore accelerometers ( N  = 8) after the 3-week mCIMT protocol.
","[{'ForeName': 'Young Sub', 'Initials': 'YS', 'LastName': 'Hwang', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jeong-Yi', 'Initials': 'JY', 'LastName': 'Kwon', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea.'}]",Neuropediatrics,['10.1055/s-0040-1702220']
463,31662381,Whole family-based physical activity promotion intervention: the Families Reporting Every Step to Health pilot randomised controlled trial protocol.,"INTRODUCTION


Family-based physical activity (PA) interventions present a promising avenue to promote children's activity; however, high-quality experimental research is lacking. This paper describes the protocol for the FRESH (Families Reporting Every Step to Health) pilot trial, a child-led family-based PA intervention delivered online.
METHODS AND ANALYSIS


FRESH is a three-armed, parallel-group, randomised controlled pilot trial using a 1:1:1 allocation ratio with follow-up assessments at 8 and 52 weeks postbaseline. Families will be eligible if a minimum of one child in school Years 3-6 (aged 7-11 years) and at least one adult responsible for that child are willing to participate. Family members can take part in the intervention irrespective of their participation in the accompanying evaluation and vice versa.Following baseline assessment, families will be randomly allocated to one of three arms: (1) FRESH; (2) pedometer-only or (3) no-intervention control. All family members in the pedometer-only and FRESH arms receive pedometers and generic PA promotion information. FRESH families additionally receive access to the intervention website; allowing participants to select step challenges to 'travel' to target cities around the world, log steps and track progress as they virtually globetrot. Control families will receive no treatment. All family members will be eligible to participate in the evaluation with two follow-ups (8 and 52 weeks). Physical (eg, fitness and blood pressure), psychosocial (eg, social support) and behavioural (eg, objectively measured family PA) measures will be collected at each time point. At 8-week follow-up, a mixed methods process evaluation will be conducted (questionnaires and family focus groups) assessing acceptability of the intervention and evaluation. FRESH families' website engagement will also be explored.
ETHICS AND DISSEMINATION


This study received ethical approval from the Ethics Committee for the School of the Humanities and Social Sciences at the University of Cambridge. Findings will be disseminated via peer-reviewed publications, conferences and to participating families.
TRIAL REGISTRATION NUMBER


ISRCTN12789422.",2019,"FRESH families additionally receive access to the intervention website; allowing participants to select step challenges to 'travel' to target cities around the world, log steps and track progress as they virtually globetrot.",['Families will be eligible if a minimum of one child in school Years 3-6 (aged 7-11 years) and at least one adult responsible for that child are willing to participate'],"['Whole family-based physical activity promotion intervention', 'Family-based physical activity (PA) interventions', 'child-led family-based PA intervention delivered online', 'FRESH; (2) pedometer-only or (3) no-intervention control']","['Physical (eg, fitness and blood pressure), psychosocial (eg, social support) and behavioural (eg, objectively measured family PA) measures']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0037438'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",,0.0646976,"FRESH families additionally receive access to the intervention website; allowing participants to select step challenges to 'travel' to target cities around the world, log steps and track progress as they virtually globetrot.","[{'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Guagliano', 'Affiliation': 'MRC Epidemiology Unit and UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, UK justin.guagliano@mrc-epid.cam.ac.uk.'}, {'ForeName': 'Helen Elizabeth', 'Initials': 'HE', 'LastName': 'Brown', 'Affiliation': 'MRC Epidemiology Unit and UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Coombes', 'Affiliation': 'Norwich Medical School and UKCRC Centre for Diet and Activity Research, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Haines', 'Affiliation': 'MRC Epidemiology Unit and UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hughes', 'Affiliation': 'Centre for Family Research, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Jones', 'Affiliation': 'Norwich Medical School and UKCRC Centre for Diet and Activity Research, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Morton', 'Affiliation': 'MRC Epidemiology Unit and UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'van Sluijs', 'Affiliation': 'MRC Epidemiology Unit and UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, UK.'}]",BMJ open,['10.1136/bmjopen-2019-030902']
464,32144049,Effects of Bladder Cancer on UK Healthcare Costs and Patient Health-Related Quality of Life: Evidence From the BOXIT Trial.,"BACKGROUND


Limited evidence exists regarding the cost and health-related quality of life (HRQoL) effects of non-muscle-invasive bladder cancer (NMIBC) recurrence and progression to muscle-invasive bladder cancer (MIBC). We examined these effects using evidence from a recent randomized control trial.
MATERIAL AND METHODS


The costs and HRQoL associated with bladder cancer were assessed using data from the BOXIT trial (bladder COX-2 inhibition trial; n = 472). The cost and HRQoL effects from clinical events were estimated using generalized estimating equations. The costs were derived from the recorded resource usage and UK unit costs. HRQoL was assessed using the EQ-5D-3L and reported UK preference tariffs. The events were categorized using the TMN classification.
RESULTS


Cases of grade 3 recurrence and progression were associated with statistically significant HRQoL decrements (-0.08; 95% confidence interval [CI], -0.13 to -0.03; and -0.10; 95% CI, -0.17 to -0.03, respectively). The 3-year average cost per NMIBC patient was estimated at £8735 (95% CI, 8325-9145). Cases of grade 1, 2, and 3 recurrence were associated with annual cost effects of £1218 (95% CI, 403-2033), £1677 (95% CI, 920-2433), and £3957 (95% CI, 2332-5583), respectively. Progression to MIBC was associated with an average increase in costs of £5407 (95% CI, 2663-8152).
CONCLUSION


Evidence from the BOXIT trial suggests that patients with NMIBC will both experience decrements in HRQoL and incur significant costs, especially in the event of a grade 3 recurrence or a progression to MIBC.",2020,"Progression to MIBC was associated with an average increase in costs of £5407 (95% CI, 2663-8152).
",[],[],"['UK Healthcare Costs and Patient Health-Related Quality of Life', 'cost and HRQoL effects', 'annual cost effects', '3-year average cost per NMIBC patient', 'costs and HRQoL associated with bladder cancer', 'HRQoL', 'HRQoL decrements']",[],[],"[{'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}]",,0.300627,"Progression to MIBC was associated with an average increase in costs of £5407 (95% CI, 2663-8152).
","[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Cox', 'Affiliation': 'Centre for Health Economics, University of York, York, United Kingdom. Electronic address: edward.cox@york.ac.uk.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Saramago', 'Affiliation': 'Centre for Health Economics, University of York, York, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kelly', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, United Kingdom; Department of Urology, University College London Hospital, London, United Kingdom.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Porta', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Wei Shen', 'Initials': 'WS', 'LastName': 'Tan', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, United Kingdom; Department of Urology, Imperial College Healthcare, London, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sculpher', 'Affiliation': 'Centre for Health Economics, University of York, York, United Kingdom.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Soares', 'Affiliation': 'Centre for Health Economics, University of York, York, United Kingdom.'}]",Clinical genitourinary cancer,['10.1016/j.clgc.2019.12.004']
465,30888034,Rationale and Study Design of a Randomized Clinical Trial of Metformin to Prevent Frailty in Older Adults With Prediabetes.,"BACKGROUND


Frailty is a geriatric syndrome that leads to poor health outcomes with aging. Previous studies have demonstrated that insulin resistance and inflammation predict frailty onset. Metformin is a widely used, well-tolerated drug that improves insulin sensitivity and displays anti-inflammatory properties. It is also known to prevent diabetes onset in adults with prediabetes. We hypothesize that metformin in older adults with prediabetes will promote healthy aging and prevent frailty. Here we describe an ongoing placebo-controlled, double-blinded clinical trial of metformin for the prevention of frailty in older adults with prediabetes.
METHODS


Older adults aged more than 65 years are randomized to metformin or placebo and are followed for 2 years. Prediabetes, required for inclusion, is assessed by 2-hour oral glucose tolerance test. Exclusion criteria are baseline frailty (Fried criteria), diabetes, dementia, untreated depression, active malignancy, or severe cardiovascular, pulmonary, and neurologic diseases. Primary outcome is frailty; secondary outcomes are physical function (Short Physical Performance Battery), systemic and skeletal muscle tissue inflammation, muscle insulin signaling, insulin sensitivity (insulin clamp), glucose tolerance (oral glucose tolerance test), and body composition (dual-energy x-ray absorptiometry). Subjects are followed every 3 months for safety assessments and every 6 months for frailty assessment (Fried criteria) and oral glucose tolerance test, and every 12 or 24 months for secondary outcomes. Enrollment of 120 subjects (completers) will take place over a 2-year period.
CONCLUSION


Metformin is being examined in this study as a potential therapeutic agent to prevent frailty in older adults with prediabetes. Findings from this trial may have future implications for the screening and potential treatment of prediabetes in older patients with metformin for the prevention of frailty.",2020,Findings from this trial may have future implications for the screening and potential treatment of pre-diabetes in older patients with metformin for the prevention of frailty.,"['older adults with pre-diabetes', 'adults with pre-diabetes', '120 subjects (completers) will take place over a 2 year period', 'older patients with', 'Older adults aged 65+ years', 'Older Adults with Pre-Diabetes']","['Metformin', 'placebo', 'metformin or placebo', 'metformin']","['physical function (short physical performance battery), systemic and skeletal muscle tissue inflammation, muscle insulin signaling, insulin sensitivity (insulin clamp), glucose tolerance (OGTT), and body composition (dual-energy x-ray absorptiometry']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C1959759', 'cui_str': 'Skeletal muscle tissue (body structure)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}]",,0.124901,Findings from this trial may have future implications for the screening and potential treatment of pre-diabetes in older patients with metformin for the prevention of frailty.,"[{'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Espinoza', 'Affiliation': 'Division of Geriatrics, Gerontology, and Palliative Medicine, Department of Medicine, University of Texas Health Science Center at San Antonio, Texas.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Musi', 'Affiliation': 'Sam and Ann Barshop Institute for Longevity and Aging Studies, University of Texas Health Science Center at San Antonio, Texas.'}, {'ForeName': 'Chen-Pin', 'Initials': 'CP', 'LastName': 'Wang', 'Affiliation': 'Sam and Ann Barshop Institute for Longevity and Aging Studies, University of Texas Health Science Center at San Antonio, Texas.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Michalek', 'Affiliation': 'Department of Epidemiology and Biostatistics, Texas.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Orsak', 'Affiliation': 'Sam and Ann Barshop Institute for Longevity and Aging Studies, University of Texas Health Science Center at San Antonio, Texas.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Romo', 'Affiliation': 'Sam and Ann Barshop Institute for Longevity and Aging Studies, University of Texas Health Science Center at San Antonio, Texas.'}, {'ForeName': 'Becky', 'Initials': 'B', 'LastName': 'Powers', 'Affiliation': 'Division of Geriatrics, Gerontology, and Palliative Medicine, Department of Medicine, University of Texas Health Science Center at San Antonio, Texas.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Conde', 'Affiliation': 'Sam and Ann Barshop Institute for Longevity and Aging Studies, University of Texas Health Science Center at San Antonio, Texas.'}, {'ForeName': 'Melody', 'Initials': 'M', 'LastName': 'Moris', 'Affiliation': 'Sam and Ann Barshop Institute for Longevity and Aging Studies, University of Texas Health Science Center at San Antonio, Texas.'}, {'ForeName': 'Darcy', 'Initials': 'D', 'LastName': 'Bair-Kelps', 'Affiliation': 'Sam and Ann Barshop Institute for Longevity and Aging Studies, University of Texas Health Science Center at San Antonio, Texas.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Sam and Ann Barshop Institute for Longevity and Aging Studies, University of Texas Health Science Center at San Antonio, Texas.'}, {'ForeName': 'Vinutha', 'Initials': 'V', 'LastName': 'Ganapathy', 'Affiliation': 'Sam and Ann Barshop Institute for Longevity and Aging Studies, University of Texas Health Science Center at San Antonio, Texas.'}, {'ForeName': 'Tyson E', 'Initials': 'TE', 'LastName': 'Jergensen', 'Affiliation': 'Sam and Ann Barshop Institute for Longevity and Aging Studies, University of Texas Health Science Center at San Antonio, Texas.'}, {'ForeName': 'Lauri C', 'Initials': 'LC', 'LastName': 'Kelly', 'Affiliation': 'Sam and Ann Barshop Institute for Longevity and Aging Studies, University of Texas Health Science Center at San Antonio, Texas.'}, {'ForeName': 'Rozmin', 'Initials': 'R', 'LastName': 'Jiwani', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, South Texas Veterans Health Care System, San Antonio, Texas.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz078']
466,32032738,Transcranial direct current stimulation (tDCS) elicits stimulus-specific enhancement of cortical plasticity.,"BACKGROUND


Deficits in plasticity underlie many severe psychiatric disorders. Transcranial direct current stimulation (tDCS) is a promising method for modulating plasticity. However, given its non-focal nature, there are open questions as to how targeting and outcome specificity can best be achieved.
OBJECTIVE


Understanding how tDCS interacts with concurrent brain activity is necessary for the rational advancement of tDCS. In the present study, we use an event-related potential (ERP) paradigm to assess the stimulus-specific effects of tDCS on cortical plasticity.
METHODS


22 healthy volunteers underwent a blinded, sham-controlled plasticity paradigm in a crossover design. High frequency presentation of auditory stimuli was used to induce potentiation in specific components of the ERP. We investigated whether anodal tDCS targeting the auditory cortex would modulate plasticity induction across time. Two pure tones were used as stimuli, only one of the tones, the target tone, was used for plasticity induction. Plasticity was quantified as change in the mean amplitude of the N100 component relative to baseline.
RESULTS


TDCS significantly modulated plasticity in the target tone compared to sham (p ​= ​0.02) but had no effect on the control tone (p ​= ​0.73). This effect was time dependent, with tDCS effects no longer apparent 30 ​min after stimulation.
CONCLUSIONS


Our results indicate that tDCS can modulate cortical plasticity in the auditory cortex in an activity-dependent manner. These findings bolster the idea that tDCS can be an effective tool to target and modulate plasticity both for research and therapeutic purposes.",2020,"RESULTS


TDCS significantly modulated plasticity in the target tone compared to sham (p = 0.02) but had no effect on the control tone (p = 0.73).",['22 healthy volunteers'],"['tDCS', 'Transcranial direct current stimulation (tDCS', 'sham-controlled plasticity paradigm', 'anodal tDCS']","['control tone', 'Plasticity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0678558', 'cui_str': 'Plasticity'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0678558', 'cui_str': 'Plasticity'}]",22.0,0.0688516,"RESULTS


TDCS significantly modulated plasticity in the target tone compared to sham (p = 0.02) but had no effect on the control tone (p = 0.73).","[{'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Boroda', 'Affiliation': 'Department of Neuroscience, University of Minnesota, Suite 516 717 Delaware Street SE, Minneapolis, MN, 55414, USA. Electronic address: borod002@umn.edu.'}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Sponheim', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Suite 516 717 Delaware Street SE, Minneapolis, MN, 55414, USA. Electronic address: kolim@umn.edu.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Fiecas', 'Affiliation': 'School of Public Health, Department of Biostatistics, University of Minnesota, A454 420 Delaware Street SE, Minneapolis, MN, 55414, USA. Electronic address: mfiecus@umn.edu.'}, {'ForeName': 'Kelvin O', 'Initials': 'KO', 'LastName': 'Lim', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Suite 516 717 Delaware Street SE, Minneapolis, MN, 55414, USA. Electronic address: sponh001@umn.edu.'}]",NeuroImage,['10.1016/j.neuroimage.2020.116598']
467,32144833,"The effect of resveratrol supplementation on serum levels of asymmetric de-methyl-arginine and paraoxonase 1 activity in patients with type 2 diabetes: A randomized, double-blind controlled trial.","The present study sought to investigate the effect of micronized resveratrol supplementation on serum levels of asymmetric de-methyl-arginine (ADMA) and paraoxonase-1 (PON1) activity in patients with type 2 diabetes (T2D). In this double-blinded randomized trial, 76 patients with T2D were recruited. Participants were randomly assigned to consume 1,000 mg resveratrol or placebo capsules (methylcellulose) per day, for 8 weeks. Serum levels of ADMA and PON1 enzyme activity were measured at the beginning and end of the intervention using the enzyme-linked immunosorbent assay method. In total, 71 participants completed the study. Our results showed that resveratrol significantly decreased serum levels of ADMA (-0.16 ± 0.11, p < .001) and improved PON1 enzyme activity (15.39 ± 13.99, p < .001) compared with placebo, after adjusting for confounding factors (age, sex, and baseline body mass index). Our findings suggest that 8-week resveratrol supplementation may produce beneficial effects on serum levels of ADMA and PON1 enzyme activity in patients with T2DM. However, further research is needed to confirm the veracity of these results.",2020,"Our results showed that resveratrol significantly decreased serum levels of ADMA (-0.16 ± 0.11, p < .001) and improved PON1 enzyme activity (15.39 ± 13.99, p < .001) compared with placebo, after adjusting for confounding factors (age, sex, and baseline body mass index).","['71 participants completed the study', 'patients with type 2 diabetes', '76 patients with T2D were recruited', 'patients with T2DM', 'patients with type 2 diabetes (T2D']","['consume 1,000\u2009mg resveratrol or placebo', 'micronized resveratrol supplementation', 'placebo', 'resveratrol supplementation']","['PON1 enzyme activity', 'Serum levels of ADMA and PON1 enzyme activity', 'serum levels of ADMA', 'serum levels of ADMA and PON1 enzyme activity', 'serum levels of asymmetric de-methyl-arginine (ADMA) and paraoxonase-1 (PON1) activity']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C2930481', 'cui_str': 'cis-Resveratrol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0243102', 'cui_str': 'enzyme activity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C1121571', 'cui_str': 'Paraoxonase 1'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",76.0,0.344008,"Our results showed that resveratrol significantly decreased serum levels of ADMA (-0.16 ± 0.11, p < .001) and improved PON1 enzyme activity (15.39 ± 13.99, p < .001) compared with placebo, after adjusting for confounding factors (age, sex, and baseline body mass index).","[{'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Tabatabaie', 'Affiliation': 'Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Abdollahi', 'Affiliation': 'Department of Nutrition and Public Health, School of Public Health, North Khorasan University, Bojnurd, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Salehi-Abargouei', 'Affiliation': 'Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Cain C T', 'Initials': 'CCT', 'LastName': 'Clark', 'Affiliation': 'Centre for Sport, Exercise, and Life Sciences, Coventry University, Coventry, UK.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Karimi-Nazari', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Fallahzadeh', 'Affiliation': 'Department of Biostatistics and Epidemiology, Research Center of Prevention and Epidemiology of Non-Communicable Disease, School of Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Rahmanian', 'Affiliation': 'Yazd Diabetic Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Mozaffari-Khosravi', 'Affiliation': 'Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6655']
468,29232576,Effects of oxytocin on cortisol reactivity and conflict resolution behaviors among couples with substance misuse.,"Social stress, particularly in the form of dyadic conflict, is a well-established correlate of substance use disorders (SUD). The neuropeptide oxytocin can enhance prosocial behavior and mitigate addictive behaviors. These effects may be, in part, a result of oxytocin's ability to attenuate hypothalamic-pituitary-adrenal (HPA) axis dysregulation. However, only one study to date has examined the effects of oxytocin on neuroendocrine reactivity or conflict resolution behavior among couples. Participants (N = 33 couples or 66 total participants) were heterosexual couples in which one or both partners endorsed substance misuse. Using a double-blind, placebo-controlled, repeated-measures design and an evidence-based behavioral coding system, we compared the impact of oxytocin (40 IU) vs. placebo on cortisol reactivity and conflict resolution behaviors. Among women, oxytocin attenuated cortisol response following the task. Oxytocin was also associated with increased Distress Maintaining Attributions and decreased Relationship Enhancing Attributions. Among men, oxytocin was associated with decreased Distress Maintaining Attributions, and both oxytocin and placebo yielded declines in Relationship Enhancing Attributions. The findings support emerging hypotheses that oxytocin may have differential effects in men and women, and indicate the need for future efforts to translate oxytocin's positive neurobiological effects into therapeutic behavioral changes.",2018,"Among men, oxytocin was associated with decreased Distress Maintaining Attributions, and both oxytocin and placebo yielded declines in Relationship Enhancing Attributions.","['couples with substance misuse', 'men and women', 'Participants (N = 33 couples or 66 total participants) were heterosexual couples in which one or both partners endorsed substance misuse']","['neuropeptide oxytocin', 'placebo', 'oxytocin', 'Oxytocin']","['cortisol reactivity and conflict resolution behaviors', 'Distress Maintaining Attributions', 'cortisol response', 'prosocial behavior and mitigate addictive behaviors']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0682323', 'cui_str': 'Companion'}]","[{'cui': 'C0027895', 'cui_str': 'Neuropeptides'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0150526', 'cui_str': 'Conflict Resolution'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}]",,0.0998516,"Among men, oxytocin was associated with decreased Distress Maintaining Attributions, and both oxytocin and placebo yielded declines in Relationship Enhancing Attributions.","[{'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA. Electronic address: Hellmuth@musc.edu.'}, {'ForeName': 'Melanie S', 'Initials': 'MS', 'LastName': 'Fischer', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Nietert', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Sudie E', 'Initials': 'SE', 'LastName': 'Back', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA.'}, {'ForeName': 'Megan Moran-Santa', 'Initials': 'MM', 'LastName': 'Maria', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Snead', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA.'}]",Psychiatry research,['10.1016/j.psychres.2017.12.003']
469,30131297,Eradication of persistent methicillin-resistant Staphylococcus aureus infection in cystic fibrosis.,"BACKGROUND


The prevalence of methicillin-resistant Staphylococcus aureus (MRSA) in individuals with cystic fibrosis (CF) has increased significantly. While studies demonstrate that persistent MRSA infection in CF is associated with poor clinical outcomes, there are no randomized controlled studies informing management.
METHODS


The Persistent MRSA Eradication Protocol was a double-blind, randomized, placebo-controlled study investigating a comprehensive 28-day treatment regimen with or without inhaled vancomycin for eradication of MRSA. Eligible participants had CF and documented persistent MRSA infection. All participants received oral antibiotics, topical decontamination, and environmental cleaning and were randomized to receive inhaled vancomycin or inhaled placebo. The primary outcome was the difference in MRSA eradication rates one month after completion of the treatment protocol.
RESULTS


29 participants were randomized. Four subjects in the inhaled vancomycin group required withdrawal from the study for bronchospasm before outcome data were collected and were excluded from analysis. There was no difference in the primary outcome: 2/10 (20%) of subjects in the intervention group and 3/15 (20%) in the placebo group had a MRSA negative sputum culture one month after treatment. There were no statistically significant differences in the rates of MRSA eradication at the end of treatment or three months after treatment completion.
CONCLUSIONS


This study suggests that persistent MRSA infection is difficult to eradicate, even with multimodal antibiotics. The use of a single course of inhaled vancomycin may not lead to higher rates of MRSA eradication in individuals with CF and may be associated with bronchospasm. FUND: This trial was financially supported by the Cystic Fibrosis Foundation.",2019,"There were no statistically significant differences in the rates of MRSA eradication at the end of treatment or three months after treatment completion.
","['individuals with CF', '29 participants were randomized', 'FUND', 'Eligible participants had CF and documented persistent MRSA infection', 'individuals with cystic fibrosis (CF', 'cystic fibrosis']","['inhaled vancomycin or inhaled placebo', 'vancomycin', 'placebo', 'oral antibiotics, topical decontamination, and environmental cleaning']","['MRSA eradication', 'MRSA eradication rates', 'rates of MRSA eradication', 'MRSA negative sputum culture']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C1265292', 'cui_str': 'MRSA'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0011121', 'cui_str': 'Decontamination'}]","[{'cui': 'C1265292', 'cui_str': 'MRSA'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0523174', 'cui_str': 'Microbial culture of sputum (procedure)'}]",29.0,0.536828,"There were no statistically significant differences in the rates of MRSA eradication at the end of treatment or three months after treatment completion.
","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Dezube', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, The Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Jennings', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, The Johns Hopkins University School of Medicine, Baltimore, MD, United States. Electronic address: mjenni15@jhmi.edu.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Rykiel', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, The Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Diener-West', 'Affiliation': 'Departments of Biostatistics and Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Boyle', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, The Johns Hopkins University School of Medicine, Baltimore, MD, United States; The Cystic Fibrosis Foundation, Bethesda, MD, United States.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Chmiel', 'Affiliation': ""Department of Pediatrics, University Hospitals Rainbow Babies and Children's Hospital, Case Western Reserve University School of Medicine, Cleveland, OH, United States.""}, {'ForeName': 'Elliott C', 'Initials': 'EC', 'LastName': 'Dasenbrook', 'Affiliation': 'Respiratory Institute, The Cleveland Clinic, Cleveland, OH, United States.'}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2018.07.005']
470,29860917,Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer.,"BACKGROUND


The recurrence score based on the 21-gene breast cancer assay predicts chemotherapy benefit if it is high and a low risk of recurrence in the absence of chemotherapy if it is low; however, there is uncertainty about the benefit of chemotherapy for most patients, who have a midrange score.
METHODS


We performed a prospective trial involving 10,273 women with hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, axillary node-negative breast cancer. Of the 9719 eligible patients with follow-up information, 6711 (69%) had a midrange recurrence score of 11 to 25 and were randomly assigned to receive either chemoendocrine therapy or endocrine therapy alone. The trial was designed to show noninferiority of endocrine therapy alone for invasive disease-free survival (defined as freedom from invasive disease recurrence, second primary cancer, or death).
RESULTS


Endocrine therapy was noninferior to chemoendocrine therapy in the analysis of invasive disease-free survival (hazard ratio for invasive disease recurrence, second primary cancer, or death [endocrine vs. chemoendocrine therapy], 1.08; 95% confidence interval, 0.94 to 1.24; P=0.26). At 9 years, the two treatment groups had similar rates of invasive disease-free survival (83.3% in the endocrine-therapy group and 84.3% in the chemoendocrine-therapy group), freedom from disease recurrence at a distant site (94.5% and 95.0%) or at a distant or local-regional site (92.2% and 92.9%), and overall survival (93.9% and 93.8%). The chemotherapy benefit for invasive disease-free survival varied with the combination of recurrence score and age (P=0.004), with some benefit of chemotherapy found in women 50 years of age or younger with a recurrence score of 16 to 25.
CONCLUSIONS


Adjuvant endocrine therapy and chemoendocrine therapy had similar efficacy in women with hormone-receptor-positive, HER2-negative, axillary node-negative breast cancer who had a midrange 21-gene recurrence score, although some benefit of chemotherapy was found in some women 50 years of age or younger. (Funded by the National Cancer Institute and others; TAILORx ClinicalTrials.gov number, NCT00310180 .).",2018,"At 9 years, the two treatment groups had similar rates of invasive disease-free survival (83.3% in the endocrine-therapy group and 84.3% in the chemoendocrine-therapy group), freedom from disease recurrence at a distant site (94.5% and 95.0%) or at a distant or local-regional site (92.2% and 92.9%), and overall survival (93.9% and 93.8%).","['women 50 years of age or younger', 'Breast Cancer', '10,273 women with hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, axillary node-negative breast cancer', '9719 eligible patients with follow-up information, 6711 (69%) had a midrange recurrence score of 11 to 25', 'women with hormone-receptor-positive, HER2-negative, axillary node-negative breast cancer who had a midrange 21-gene recurrence score', 'women 50 years of age or younger with a recurrence score of 16 to 25']","['endocrine therapy and chemoendocrine therapy', 'endocrine therapy alone', 'chemoendocrine therapy or endocrine therapy alone']","['freedom from disease recurrence', 'rates of invasive disease-free survival', 'overall survival', 'invasive disease-free survival']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0017337', 'cui_str': 'Genes'}]","[{'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",10273.0,0.289962,"At 9 years, the two treatment groups had similar rates of invasive disease-free survival (83.3% in the endocrine-therapy group and 84.3% in the chemoendocrine-therapy group), freedom from disease recurrence at a distant site (94.5% and 95.0%) or at a distant or local-regional site (92.2% and 92.9%), and overall survival (93.9% and 93.8%).","[{'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sparano', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gray', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'Della F', 'Initials': 'DF', 'LastName': 'Makower', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'Kathleen I', 'Initials': 'KI', 'LastName': 'Pritchard', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Albain', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hayes', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Geyer', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Dees', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Goetz', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Olson', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Lively', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Badve', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Saphner', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Whelan', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Ellis', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'Soonmyung', 'Initials': 'S', 'LastName': 'Paik', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Wood', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Ravdin', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'Maccon M', 'Initials': 'MM', 'LastName': 'Keane', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'Henry L', 'Initials': 'HL', 'LastName': 'Gomez Moreno', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'Pavan S', 'Initials': 'PS', 'LastName': 'Reddy', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Goggins', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'Ingrid A', 'Initials': 'IA', 'LastName': 'Mayer', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Brufsky', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Toppmeyer', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'Virginia G', 'Initials': 'VG', 'LastName': 'Kaklamani', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Berenberg', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Abrams', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Sledge', 'Affiliation': 'From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).'}]",The New England journal of medicine,['10.1056/NEJMoa1804710']
471,31973934,Comparison of effectiveness coolant spray and placebo in patients with acute ankle trauma prospective randomized controlled trial.,"INTRODUCTION


Coolant spray application in musculoskeletal injuries is an effective and harmless method to treat pain and reduce functional limitation. This study assessed the clinical value of coolant spray application on patient comfort before and during the radiographic imaging process along with its early analgesic and anti-edema effects.
METHODS


A total of 155 patients, admitted to the emergency department between April 1, 2019, and June 31, 2019, were included in this study. The patients were randomly assigned to either a coolant spray or a saline spray (placebo) group. To the coolant spray group patients, Cryos ®Spray (Phyto Performance, Italy) was applied. To the placebo group patients, a normal saline solution in a bottle covered with white opaque paper and refrigerated at 4 °C was sprayed. Radiographic images of the patients were scored for appropriateness of the standard imaging characteristics.
RESULTS


The mean scores were 8.13 ± 1.8 and 6.58 ± 2.2 for the coolant spray and normal saline spray groups, respectively; the differences were statistically significant between the two groups (mean difference: -1.56, 95% CI:-2.20 to -0.92; p = .000). Patients with fractures on their radiographs and treated with coolant spray received higher scores than similar patients treated with normal saline spray (mean difference:-1.92, 95% CI:-3.28 to -0.55; p = .009). The proportion of patients requesting analgesic treatment before discharge was statistically lower in the coolant spray group compared to the normal saline group (p = .025).
CONCLUSIONS


The radiographic images taken after coolant spray intervention in patients with acute ankle trauma were more successful in showing the target structures.",2020,"The proportion of patients requesting analgesic treatment before discharge was statistically lower in the coolant spray group compared to the normal saline group (p = .025).
","['155 patients, admitted to the emergency department between April 1, 2019, and June 31, 2019, were included in this study', 'patients with acute ankle trauma']","['coolant spray or a saline spray (placebo', 'placebo', 'normal saline solution', 'normal saline spray', 'coolant spray']","['proportion of patients requesting analgesic treatment before discharge', 'mean scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}]","[{'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",155.0,0.112359,"The proportion of patients requesting analgesic treatment before discharge was statistically lower in the coolant spray group compared to the normal saline group (p = .025).
","[{'ForeName': 'Sultan Tuna Akgol', 'Initials': 'STA', 'LastName': 'Gur', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey. Electronic address: sultantuna@hotmail.com.'}, {'ForeName': 'Sinem', 'Initials': 'S', 'LastName': 'Dogruyol', 'Affiliation': 'Department of Emergency Medicine, Manisa Merkez Efendi State Hospital, Manisa, Turkey.'}, {'ForeName': 'Abdullah Osman', 'Initials': 'AO', 'LastName': 'Kocak', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Akbas', 'Affiliation': 'Department of Emergency Medicine, Bingol State Hospital, Bingol, Turkey.'}, {'ForeName': 'Kutsi', 'Initials': 'K', 'LastName': 'Tuncer', 'Affiliation': 'Orthopedics and Traumatology, Department of Orthopedics and Traumatology, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Karabulut', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Cakir', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.12.054']
472,31972848,Health Literacy and Outcomes of a Community-Based Self-Help Intervention: A Case of Korean Americans With Type 2 Diabetes.,"BACKGROUND


Although scientific reports increasingly document the negative impact of inadequate health literacy on health-seeking behaviors, health literacy's effect on health outcomes in patients with diabetes is not entirely clear, owing to insufficient empirical studies, mixed findings, and insufficient longitudinal research.
OBJECTIVE


The aim of this study was to empirically examine underlying mechanisms of health literacy's role in diabetes management among a group of Korean Americans with Type 2 diabetes mellitus.
METHODS


Data from a randomized clinical trial of a health literacy-focused Type 2 diabetes self-management intervention conducted during 2012-2016 in the Korean American community were collected at baseline and at 3, 6, 9, and 12 months. A total of 250 Korean Americans with Type 2 diabetes participated (intervention, 120; control, 130). Participants were first-generation Korean American immigrants. Health literacy knowledge was measured with the original Rapid Estimate of Adult Literacy in Medicine and the diabetes mellitus-specific Rapid Estimate of Adult Literacy in Medicine. Functional health literacy was measured with the numeracy subscale of the Test of Functional Health Literacy in Adults and the Newest Vital Sign screening instrument, which also uses numeracy. Primary outcomes included glucose control and diabetes quality of life. Multivariate analyses included latent variable modeling.
RESULTS


A series of path analyses identified self-efficacy and self-care skills as significant mediators between health literacy and glucose control and quality of life. Education and acculturation were the most significant correlates of health literacy.
DISCUSSION


Despite inconsistent findings in the literature, this study indicates that health literacy may indirectly influence health outcomes through mediators such as self-care skills and self-efficacy. The study highlights the importance of health literacy, as well as underlying mechanisms with which health literacy influences processes and outcomes of diabetes self-management.",2020,A series of path analyses identified self-efficacy and self-care skills as significant mediators between health literacy and glucose control and quality of life.,"['Korean Americans with Type 2 Diabetes', 'patients with diabetes', '250 Korean Americans with type 2 diabetes participated (intervention, 120; control, 130', 'Korean Americans with type 2 diabetes mellitus', 'Participants were first-generation Korean American immigrants']","['health literacy-focused type 2 diabetes self-management intervention', 'Community-Based Self-Help Intervention']","['glucose control and diabetes quality of life', 'health literacy', 'Health literacy knowledge', 'Functional health literacy', 'health literacy and glucose control and quality of life']","[{'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0597921', 'cui_str': 'Korean Americans'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0034380'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",250.0,0.0347658,A series of path analyses identified self-efficacy and self-care skills as significant mediators between health literacy and glucose control and quality of life.,"[{'ForeName': 'Miyong T', 'Initials': 'MT', 'LastName': 'Kim', 'Affiliation': 'Miyong T. Kim, PhD, RN, FAAN, is Professor, School of Nursing, The University of Texas at Austin. Kim B. Kim, PhD, is President, Korean Resource Center, Ellicott City, Maryland. Jisook Ko, PhD, RN, is Assistant Professor, The University of Texas Health Science Center at San Antonio. Nicole Murry, RN, PhD, is Assistant Professor, School of Nursing, The University of Texas at Austin. Bo Xie, PhD, is Professor, School of Nursing, The University of Texas at Austin. Kavita Radhakrishnan, RN, PhD, is Associate Professor, School of Nursing, The University of Texas at Austin. Hae-Ra Han, PhD, RN, FAAN, is Professor, Johns Hopkins University School of Nursing, Baltimore, Maryland.'}, {'ForeName': 'Kim B', 'Initials': 'KB', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Jisook', 'Initials': 'J', 'LastName': 'Ko', 'Affiliation': ''}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Murry', 'Affiliation': ''}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xie', 'Affiliation': ''}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Radhakrishnan', 'Affiliation': ''}, {'ForeName': 'Hae-Ra', 'Initials': 'HR', 'LastName': 'Han', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000409']
473,31983575,"Effect of 5-lipoxygenase inhibitor, VIA-2291 (Atreleuton), on epicardial fat volume in patients with recent acute coronary syndrome.","BACKGROUND AND AIMS


The association between inflammation and atherosclerosis has been well described in the literature. There is now mounting evidence in support of adipose tissue as a reservoir for inflammatory markers. Epicardial adipose tissue (EAT) has been shown to associate with coronary atherosclerosis and found to be a predictor of future adverse cardiovascular events. This study, VIA-EAT, assesses the change in epicardial fat volume (EFV) after treatment with an investigational anti-inflammatory agent (VIA-2291) in a cohort of post-acute coronary syndrome (ACS) patients.
METHODS


This study is derived from a post-hoc analysis of a previously conducted randomized clinical trial (NCT00358826). Patients were recruited for a prospective, double-blind, multi-center randomized trial of a 5-lipooxygenase inhibitor or placebo in a 3:1 randomization, including doses of placebo, and 25 mg, 50 mg and 100 mg of active treatment. Cardiac computed tomography was performed at baseline and at 24 weeks after treatment with VIA-2291. EAT and pericardial adipose tissue (PAT) were measured using previously published methodology. A Pearson correlation test was used to determine the relationship between change in epicardial fat and change in plaque composition.
RESULTS


We analyzed 54 pre- and post-treatment scans. There were no major differences between traditional cardiovascular risk factors among the 4 randomized study arms. There was a significant decrease in EAT and PAT in patients in the treatment arms vs. placebo, -3.0 ± 8.2mm3 and -3.9 ± 10.9mm3 vs. 1.7 ± 7.5mm3 and 1.4 ± 10.7mm3 (p = 0.001), respectively. The changes in EAT and PAT were more pronounced in patients taking 100 mg of the drug vs. placebo: 4.2 ± 9.6mm3, -7.6 ± 8.5mm3, p = 0.0001, respectively. In a subgroup analysis, reduction in epicardial fat volume correlated with reduction in total atherosclerotic plaque volume across all VIA treatment groups, r = 0.52 (p = 0.004).
CONCLUSIONS


After adjustment for traditional cardiovascular risk factors including age, gender, body mass index, dyslipidemia and smoking, VIA-2291 decreases EAT and PAT in individuals with recent ACS. Treatment with the drug also appears to alter plaque volume and composition.",2020,"There was a significant decrease in EAT and PAT in patients in the treatment arms vs. placebo, -3.0 ± 8.2mm3 and -3.9 ± 10.9mm3 vs. 1.7 ± ","['patients with recent acute coronary syndrome', 'cohort of post-acute coronary syndrome (ACS) patients']","['placebo, and 25\xa0mg, 50\xa0mg and 100\xa0mg of active treatment', 'investigational anti-inflammatory agent (VIA-2291', '5-lipooxygenase inhibitor or placebo', '5-lipoxygenase inhibitor, VIA-2291 (Atreleuton', 'placebo', 'Epicardial adipose tissue (EAT']","['epicardial fat volume', 'EAT and pericardial adipose tissue (PAT', 'epicardial fat and change in plaque composition', 'plaque volume and composition', 'EAT and PAT', 'epicardial fat volume (EFV', 'reduction in epicardial fat volume', 'total atherosclerotic plaque volume', 'traditional cardiovascular risk factors', 'changes in EAT and PAT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatories'}, {'cui': 'C2930557', 'cui_str': 'VIA 2291'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1289971', 'cui_str': 'Arachidonate 5-Lipoxygenase Inhibitors'}, {'cui': 'C0384233', 'cui_str': 'atreleuton'}, {'cui': 'C0442016', 'cui_str': 'Epicardial (qualifier value)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]","[{'cui': 'C0442016', 'cui_str': 'Epicardial (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0442031', 'cui_str': 'Pericardial (qualifier value)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0030587', 'cui_str': 'Paroxysmal atrial tachycardia (disorder)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2936350', 'cui_str': 'Plaque, Atherosclerotic'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",,0.430691,"There was a significant decrease in EAT and PAT in patients in the treatment arms vs. placebo, -3.0 ± 8.2mm3 and -3.9 ± 10.9mm3 vs. 1.7 ± ","[{'ForeName': 'Shone O', 'Initials': 'SO', 'LastName': 'Almeida', 'Affiliation': 'Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, 1124 West Carson St, Torrance, CA, 90502, USA. Electronic address: Shonealmeida@gmail.com.'}, {'ForeName': 'Reuben J', 'Initials': 'RJ', 'LastName': 'Ram', 'Affiliation': 'David Geffen School of Medicine at University of California Los Angeles, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Kinninger', 'Affiliation': 'Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, 1124 West Carson St, Torrance, CA, 90502, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Budoff', 'Affiliation': 'Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, 1124 West Carson St, Torrance, CA, 90502, USA.'}]",Journal of cardiovascular computed tomography,['10.1016/j.jcct.2019.12.033']
474,31974133,"Gastric microbes associated with gastric inflammation, atrophy and intestinal metaplasia 1 year after  Helicobacter pylori  eradication.","OBJECTIVE


Helicobacter pylori  is associated with gastric inflammation, precancerous gastric atrophy (GA) and intestinal metaplasia (IM). We aimed to identify microbes that are associated with progressive inflammation, GA and IM 1 year after  H. pylori  eradication.
DESIGN


A total of 587  H. pylori -positive patients were randomised to receive  H. pylori  eradication therapy (295 patients) or placebo (292 patients). Bacterial taxonomy was analysed on 404 gastric biopsy samples comprising 102 pairs before and after 1 year  H. pylori  eradication and 100 pairs before and after 1 year placebo by 16S rRNA sequencing.
RESULTS


Analysis of microbial sequences confirmed the eradication of  H. pylori  in treated group after 1 year. Principal component analysis revealed distinct microbial clusters reflected by increase in bacterial diversity (p<0.00001) after  H. pylori  eradication. While microbial interactions remained largely unchanged after placebo treatment, microbial co-occurrence was less in treated group.  Acinetobacter lwoffii ,  Streptococcus anginosus  and  Ralstonia  were enriched while  Roseburia  and  Sphingomonas  were depleted in patients with persistent inflammation 1 year after  H. pylori  eradication. A distinct cluster of oral bacteria comprising  Peptostreptococcus ,  Streptococcus ,  Parvimonas ,  Prevotella, Rothia  and  Granulicatella  were associated with emergence and persistence of GA and IM. Probiotic  Faecalibacterium praustznii  was depleted in subjects who developed GA following  H. pylori  eradication. Functional pathways including amino acid metabolism and inositol phosphate metabolism were enriched while folate biosynthesis and NOD-like receptor signalling decreased in atrophy/IM-associated gastric microbiota.
CONCLUSION


This study identified that gastric microbes contribute to the progression of gastric carcinogenesis after  H. pylori  eradication.",2020,Principal component analysis revealed distinct microbial clusters reflected by increase in bacterial diversity (p<0.00001) after  H. pylori  eradication.,"['subjects who developed GA following  H. pylori  eradication', 'A total of 587\u2009 H   ', 'pylori -positive patients']","['placebo', 'receive  H. pylori  eradication therapy']","['eradication of  H. pylori', 'bacterial diversity']","[{'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}]",587.0,0.087235,Principal component analysis revealed distinct microbial clusters reflected by increase in bacterial diversity (p<0.00001) after  H. pylori  eradication.,"[{'ForeName': 'Joseph J Y', 'Initials': 'JJY', 'LastName': 'Sung', 'Affiliation': 'Department of Medicine and Therapeutics, Chinese University of Hong Kong, New Territories, Hong Kong jjysung@cuhk.edu.hk.'}, {'ForeName': 'Olabisi Oluwabukola', 'Initials': 'OO', 'LastName': 'Coker', 'Affiliation': 'Department of Medicine and Therapeutics, Chinese University of Hong Kong, New Territories, Hong Kong.'}, {'ForeName': 'Eagle', 'Initials': 'E', 'LastName': 'Chu', 'Affiliation': 'Department of Medicine and Therapeutics, Chinese University of Hong Kong, New Territories, Hong Kong.'}, {'ForeName': 'Chun Ho', 'Initials': 'CH', 'LastName': 'Szeto', 'Affiliation': 'Department of Medicine and Therapeutics, Chinese University of Hong Kong, New Territories, Hong Kong.'}, {'ForeName': 'Simson Tsz Yat', 'Initials': 'STY', 'LastName': 'Luk', 'Affiliation': 'Department of Medicine and Therapeutics, Chinese University of Hong Kong, New Territories, Hong Kong.'}, {'ForeName': 'Harry Cheuk Hay', 'Initials': 'HCH', 'LastName': 'Lau', 'Affiliation': 'Department of Medicine and Therapeutics, Chinese University of Hong Kong, New Territories, Hong Kong.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Medicine and Therapeutics, Chinese University of Hong Kong, New Territories, Hong Kong.'}]",Gut,['10.1136/gutjnl-2019-319826']
475,31594202,Local heating of trigger points reduces neck and plantar fascia pain.,"BACKGROUND


Heating the skin and muscles is a commonly accepted method of pain relief and a modality to increase relaxation in muscles and increase tissue blood flow.
OBJECTIVE


The purpose of the present study was to examine the effect of local heat applied to trigger points and to determine if there was pain relief in the neck and plantar fascia.
METHODS


Forty adults were divided into 2 different groups according to their pain; twenty subjects had plantar foot pain and the other 20 had nonspecific neck pain. The 20 subjects in each group were randomly subdivided into a heat and a sham group. Sensitivity to pressure was measured with an algometer. A stopwatch was given to the subject and started when either the heat patch or placebo was applied. Heat cells were applied at trigger points on the pain area.
RESULTS


Subjective pain significantly decreased in both sham and heat group patients with neck pain (p< 0.05), however, the change was greater in the heat group and there was a significant difference between the heat and sham groups (p= 0.002, d= 0.81). For the plantar pain group, a significant decrease in subjective pain was found in the heat group but not in the sham group. Pressure pain threshold significantly decreased in the heat group patients both with neck and plantar pain but for the sham group there was an increase in the pressure after sham treatment. Pain relief during the intervention was also significantly different between the heat and sham group in both patients with neck and plantar pain.
CONCLUSION


The effect of local heat on trigger points of the body on pain relief was significantly better in the heat groups than in the sham groups. This finding is significant because using heat on trigger points could be an alternative to dry needling performed by healthcare professionals. This modality can be alternative for home use and avoids opioids.",2020,"Pain relief during the intervention was also significantly different between the heat and sham group in both patients with neck and plantar pain.
","['Forty adults were divided into 2 different groups according to their pain; twenty subjects had plantar foot pain and the other 20 had nonspecific neck pain', '20 subjects in each group']",['placebo'],"['subjective pain', 'Sensitivity to pressure', 'plantar pain', 'Subjective pain', 'pain relief', 'neck pain', 'Pain relief', 'Pressure pain threshold', 'neck and plantar fascia pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3715212', 'cui_str': '20'}, {'cui': 'C0016512', 'cui_str': 'Foot pain (finding)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}]",40.0,0.0170079,"Pain relief during the intervention was also significantly different between the heat and sham group in both patients with neck and plantar pain.
","[{'ForeName': 'Jerrold', 'Initials': 'J', 'LastName': 'Petrofsky', 'Affiliation': 'School of Physical Therapy, Touro University Nevada, Henderson, Nevada, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Laymon', 'Affiliation': 'School of Physical Therapy, Touro University Nevada, Henderson, Nevada, USA.'}, {'ForeName': 'Haneul', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, College of Health Science, Gachon University, Incheon, Korea.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181222']
476,31971061,Dynamic Assessment for Identifying Spanish-Speaking English Learners' Risk for Mathematics Disabilities: Does Language of Administration Matter?,"We examined dynamic assessment's (DA's) added value over traditional assessments for identifying Spanish-speaking English learners' (ELs) risk for developing mathematics disabilities, as a function of the language of test administration (English vs. Spanish), type of math outcome, and EL's language dominance. At the start of first grade, ELs ( N  = 368) were randomly assigned to English-DA or Spanish-DA conditions, were assessed on static mathematics measures and domain-general (language, reasoning) measures in English, and completed DA in their assigned language condition. At year's end, they were assessed on calculation and word-problem solving outcomes in English. Results from multigroup path models indicated that Spanish-DA mitigates the impact of ELs' language dominance on DA performance. Moreover, ELs' language dominance moderated DA's predictive validity differentially depending on DA language and type of outcome. Spanish-DA showed higher predictive validity in Spanish-dominant ELs than English-dominant ELs when predicting calculations but not word-problem solving. English-DA was predictive for both outcomes, regardless of ELs' language dominance.",2020,Spanish-DA showed higher predictive validity in Spanish-dominant ELs than English-dominant ELs when predicting calculations but not word-problem solving.,['Mathematics Disabilities'],[],"['static mathematics measures and domain-general (language, reasoning) measures in English, and completed DA']","[{'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",[],"[{'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",368.0,0.0353739,Spanish-DA showed higher predictive validity in Spanish-dominant ELs than English-dominant ELs when predicting calculations but not word-problem solving.,"[{'ForeName': 'Eunsoo', 'Initials': 'E', 'LastName': 'Cho', 'Affiliation': 'Michigan State University, East Lansing, USA.'}, {'ForeName': 'Lynn S', 'Initials': 'LS', 'LastName': 'Fuchs', 'Affiliation': 'Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Pamela M', 'Initials': 'PM', 'LastName': 'Seethaler', 'Affiliation': 'Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Fuchs', 'Affiliation': 'Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Compton', 'Affiliation': 'Florida State University, Tallahassee, USA.'}]",Journal of learning disabilities,['10.1177/0022219419898887']
477,31796677,Cerebral White Matter Integrity in Amnestic Mild Cognitive Impairment: A 1-Year Randomized Controlled Trial of Aerobic Exercise Training.,"Cerebral white matter (WM) represents the structural substrate of neuronal communications which is damaged by Alzheimer's disease (AD). Aerobic exercise training (AET) may improve WM integrity in cognitively normal older adults, but its efficacy remains unknown in patients with amnestic mild cognitive impairment (MCI), a prodromal phase of AD dementia. Therefore, we conducted a proof-of-concept study that randomized 70 amnestic MCI patients to a 1-year program of AET or a non-aerobic stretching and toning (SAT), active control group. Thirty-six patients completed both baseline and follow-up MRI scans, and cerebral WM integrity was measured by WM lesion volume and diffusion characteristics using fluid-attenuated-inversion-recovery and diffusion tensor imaging respectively. Peak oxygen uptake (VO2peak) and neuropsychological function were also measured. At baseline and 1-year follow-up, WM lesion volume and diffusion characteristics were similar between the AET and SAT groups, although VO2peak significantly improved after AET. The AET group showed slight improvement in neuropsychological performance. When analyzing individual data, tract-based spatial statistics demonstrated that VO2peak improvements are associated with attenuated elevations in mean and axial diffusivities, particularly the anterior WM fiber tracts (e.g., genu of corpus callosum). In patients with amnestic MCI, we found that although AET intervention did not improve WM integrity at group level analysis, individual cardiorespiratory fitness gains were associated with improved WM tract integrity of the prefrontal cortex.",2020,"At baseline and 1-year follow-up, WM lesion volume and diffusion characteristics were similar between the AET and SAT groups, although VO2peak significantly improved after AET.","['patients with amnestic MCI', 'Amnestic Mild Cognitive Impairment', 'cognitively normal older adults', 'patients with amnestic mild cognitive impairment (MCI), a prodromal phase of AD dementia', '70 amnestic MCI patients to a 1-year program of AET or a non-aerobic stretching and toning (SAT), active control group']","['Aerobic Exercise Training', 'Aerobic exercise training (AET']","['WM integrity', 'WM tract integrity of the prefrontal cortex', 'neuropsychological performance', 'Peak oxygen uptake (VO2peak) and neuropsychological function', 'cerebral WM integrity', 'WM lesion volume and diffusion characteristics']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0565928', 'cui_str': 'Prodromal phase (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0629582', 'cui_str': 'AETS'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0629582', 'cui_str': 'AETS'}]","[{'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}]",70.0,0.0839437,"At baseline and 1-year follow-up, WM lesion volume and diffusion characteristics were similar between the AET and SAT groups, although VO2peak significantly improved after AET.","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tarumi', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.'}, {'ForeName': 'Binu P', 'Initials': 'BP', 'LastName': 'Thomas', 'Affiliation': 'Advanced Imaging Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Benjamin Y', 'Initials': 'BY', 'LastName': 'Tseng', 'Affiliation': 'Department of Health and Kinesiology, The University of Texas at Tyler, Tyler, TX, USA.'}, {'ForeName': 'Ciwen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.'}, {'ForeName': 'Kyle B', 'Initials': 'KB', 'LastName': 'Womack', 'Affiliation': 'Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Hynan', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Hanzhang', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Advanced Imaging Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'C Munro', 'Initials': 'CM', 'LastName': 'Cullum', 'Affiliation': 'Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190875']
478,30786753,Insuring Good Health: Outcomes and Acceptability of a Participatory Health Insurance Literacy Intervention in Diverse Urban Communities.,"BACKGROUND


The U.S. uninsured rate has dropped significantly since the passage of the Affordable Care Act (ACA), yet insurance coverage remains lower in historically marginalized communities than in the overall population. New consumer engagement approaches that involve these populations are needed. The purpose of this study was to evaluate the effectiveness of the Insuring Good Health Intervention, a website and video series designed to improve engagement with health insurance and ACA reforms. The study was designed and implemented using a community-based participatory research approach.
METHOD


We conducted a lagged-control cluster randomized controlled trial to evaluate Insuring Good Health with racially and ethnically diverse adults seeking services in medically underserved areas within the Detroit, Michigan metropolitan area. Outcomes were assessed at baseline and at 6 and 9 months postintervention, and including self-efficacy, knowledge, beliefs, and intention to seek help with insurance navigation and care.
RESULTS


Among 243 participants, mean age was 43.4 ( SD = 13) years, and all participants met federal guidelines for poverty. The study had an 86% response rate at 9-month follow-up ( n = 209). Compared with the lagged-control group, intervention participants had more positive beliefs concerning preventive care (estimate 0.51, standard error 0.16; p < .01), and intention to seek help with insurance navigation and care (estimate 0.43, standard error 0.17; p < .001) at 9-month follow-up. Hispanic participants benefitted the most from the intervention, including improved knowledge of health insurance eligibility over 9 months compared with other racial/ethnic groups (estimate -0.97, standard error 0.40, p < .01).
DISCUSSION


Insuring Good Health was associated with increased intention to seek help with insurance navigation and care, and improved beliefs around preventive care.
CONCLUSIONS


Insuring Good Health has the potential to be an important consumer engagement tool to reduce disparities in health insurance coverage and care seeking.",2019,"Compared with the lagged-control group, intervention participants had more positive beliefs concerning preventive care (estimate 0.51, standard error 0.16; p < .01), and intention to seek help with insurance navigation and care (estimate 0.43, standard error 0.17; p < .001) at 9-month follow-up.","['243 participants, mean age was 43.4 ( SD = 13) years, and all participants met federal guidelines for poverty', 'Diverse Urban Communities', 'Good Health with racially and ethnically diverse adults seeking services in medically underserved areas within the Detroit, Michigan metropolitan area', 'Hispanic participants']",['Participatory Health Insurance Literacy Intervention'],"['knowledge of health insurance eligibility', 'positive beliefs concerning preventive care', 'self-efficacy, knowledge, beliefs, and intention to seek help with insurance navigation and care']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0032854', 'cui_str': 'Poverty'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0025112', 'cui_str': 'Medically Underserved Area'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}]","[{'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C4277527', 'cui_str': 'Preventive Care'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}]",243.0,0.0454085,"Compared with the lagged-control group, intervention participants had more positive beliefs concerning preventive care (estimate 0.51, standard error 0.16; p < .01), and intention to seek help with insurance navigation and care (estimate 0.43, standard error 0.17; p < .001) at 9-month follow-up.","[{'ForeName': 'Minal R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': '1 University of Michigan School of Public Health, Ann Arbor, MI, USA.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Israel', 'Affiliation': '1 University of Michigan School of Public Health, Ann Arbor, MI, USA.'}, {'ForeName': 'Peter X K', 'Initials': 'PXK', 'LastName': 'Song', 'Affiliation': '1 University of Michigan School of Public Health, Ann Arbor, MI, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hao', 'Affiliation': '1 University of Michigan School of Public Health, Ann Arbor, MI, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'TerHaar', 'Affiliation': '1 University of Michigan School of Public Health, Ann Arbor, MI, USA.'}, {'ForeName': 'Madiha', 'Initials': 'M', 'LastName': 'Tariq', 'Affiliation': '2 Arab Community Center for Economic and Social Services, Dearborn, MI, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lichtenstein', 'Affiliation': '1 University of Michigan School of Public Health, Ann Arbor, MI, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198119831060']
479,31970477,"Minodronate combined with alfacalcidol versus alfacalcidol alone for glucocorticoid-induced osteoporosis: a multicenter, randomized, comparative study.","INTRODUCTION


This study compared the clinical usefulness of minodronate (50 mg/4 weeks) plus alfacalcidol (1 μg/day) (Group M) with that of alfacalcidol alone (1 μg/day) (Group A) for treating glucocorticoid-induced osteoporosis.
MATERIALS AND METHODS


The primary endpoints were the changes from baseline in lumbar spine (LS) bone mineral density (BMD) and the cumulative incidence of vertebral fracture at 24 months; secondary endpoints included the changes from baseline in total hip (TH) BMD and bone turnover markers.
RESULTS


Of 164 patients enrolled, 152 (Group M, n = 75; Group A, n = 77) were included in the analysis of efficacy. At each time point and at 24 months, LS BMD and TH BMD were significantly higher in Group M than in Group A. The 152 patients were divided into two subgroups that were previously treated with glucocorticoids for ≤ 3 months or > 3 months. In both subgroups, the changes from baseline in LS BMD and TH BMD from baseline at 24 months had increased more in Group M than in Group A. There were no differences found in the incidence of vertebral fracture between the groups, because the number of enrolled patients was lesser than that initially expected. In Group M, both bone formation and resorption markers significantly decreased from baseline at 3 months and maintained at 6, 12, and 24 months.
CONCLUSIONS


Minodronate plus alfacalcidol was more effective than alfacalcidol alone in increasing BMD and was effective in increasing BMD for both prevention and treatment. Therefore, minodronate can be a good candidate drug for the treatment of glucocorticoid-induced osteoporosis.",2020,"In Group M, both bone formation and resorption markers significantly decreased from baseline at 3 months and maintained at 6, 12, and 24 months.
","['glucocorticoid-induced osteoporosis', '152 patients were divided into two subgroups that were previously treated with', '164 patients enrolled, 152 (Group M, n\u2009']","['glucocorticoid-induced osteoporosis', 'glucocorticoids for\u2009≤\u20093\xa0months or\u2009', 'Minodronate combined with alfacalcidol versus alfacalcidol alone', 'minodronate (50\xa0mg/4\xa0weeks) plus alfacalcidol', 'alfacalcidol alone']","['BMD', 'changes from baseline in lumbar spine (LS) bone mineral density (BMD) and the cumulative incidence of vertebral fracture', 'total hip (TH) BMD and bone turnover markers', 'LS BMD and TH BMD', 'bone formation and resorption markers', 'incidence of vertebral fracture']","[{'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0441847', 'cui_str': 'Group M (qualifier value)'}]","[{'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0662880', 'cui_str': '(1-hydroxy-2-(imidazo(1,2-a)-pyridin-3-yl)ethylidene)bisphosphonic acid monohydrate'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0044410', 'cui_str': 'Alfacalcidol'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}]",164.0,0.0338374,"In Group M, both bone formation and resorption markers significantly decreased from baseline at 3 months and maintained at 6, 12, and 24 months.
","[{'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Soen', 'Affiliation': 'Department of Orthopaedic Surgery and Rheumatology, KINDAI University Nara Hospital, Nara, Japan. nra48207@nifty.com.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Allergy and Rheumatology, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Sakae', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Ito', 'Affiliation': 'Nagasaki Study Center, The Open University of Japan, Nagasaki, Japan.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Nakano', 'Affiliation': 'Department of Orthopaedic Surgery, Tamana Central Hospital, Kumamoto, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Hagino', 'Affiliation': 'School of Health ScienceFaculty of Medicine, Tottori University, Tottori, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Hirakawa', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Fujii Memorial Institute of Medical Sciences, Tokushima University, Tokushima, Japan.'}]",Journal of bone and mineral metabolism,['10.1007/s00774-019-01077-x']
480,31714598,The efficacy of a technology-based information and coaching/support program on pain and symptoms in Asian American survivors of breast cancer.,"BACKGROUND


Pain is a common problem, especially in the first few years of breast cancer survivorship. Asian American survivors of breast cancer reportedly have inadequate cancer pain management, and subsequently report a lower quality of life compared with other racial/ethnic groups. Technology-based programs could improve the cancer pain management process. The purpose of the current study was to examine the efficacy of a technology-based information and coaching/support program on cancer pain and its accompanying symptoms among Asian American survivors of breast cancer.
METHODS


The current study adopted a randomized pretest/posttest group design. The sample included 115 Asian American survivors of breast cancer (49 in the control group and 66 in the intervention group). The participants' background features, pain (frequency and distress), accompanying symptom distress (global, physical, and psychological), and 4 theory-based mediators (attitude, self-efficacy, perceived barriers, and social influence) were measured using multiple instruments at 3 time points (pretest, after 1 month, and after 3 months). The current study used an intent-to-treat approach and conducted linear mixed model growth curve analyses.
RESULTS


There were significant decreases noted in all outcome variables, including pain and symptoms over time in both groups. There were greater decreases in physical symptom distress scores among the intervention group compared with the control group (P = .0229). The mediators as a whole significantly explained overall decreases in general, physical, and psychological symptom distress scores after 3 months in both groups and the intervention group's greater decreases in general, physical, and psychological symptom distress scores after 1 month.
CONCLUSIONS


The technology-based program described herein could help to reduce cancer pain and its accompanying symptoms among Asian American survivors of breast cancer.",2020,There were greater decreases in physical symptom distress scores among the intervention group compared with the control group (P = .0229).,"['Asian American survivors of breast cancer', '115 Asian American survivors of breast cancer (49 in the control group and 66 in the intervention group']",['technology-based information and coaching/support program'],"['pain and symptoms', 'pain and symptoms over time', 'general, physical, and psychological symptom distress scores', 'physical symptom distress scores', 'cancer pain', 'pain (frequency and distress), accompanying symptom distress (global, physical, and psychological), and 4 theory-based mediators (attitude, self-efficacy, perceived barriers, and social influence']","[{'cui': 'C0003988', 'cui_str': 'Asian Americans'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",115.0,0.0143995,There were greater decreases in physical symptom distress scores among the intervention group compared with the control group (P = .0229).,"[{'ForeName': 'Eun-Ok', 'Initials': 'EO', 'LastName': 'Im', 'Affiliation': 'School of Nursing, Duke University, Durham, North Carolina.'}, {'ForeName': 'Sangmi', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'School of Nursing, Duke University, Durham, North Carolina.'}, {'ForeName': 'You Lee', 'Initials': 'YL', 'LastName': 'Yang', 'Affiliation': 'School of Nursing, Duke University, Durham, North Carolina.'}, {'ForeName': 'Wonshik', 'Initials': 'W', 'LastName': 'Chee', 'Affiliation': 'School of Nursing, Duke University, Durham, North Carolina.'}]",Cancer,['10.1002/cncr.32579']
481,31595780,"Editorial Comment on:  Single-Use Versus Reusable Digital Flexible Ureteroscopes for the Treatment of Renal Calculi: A Prospective Multicenter Randomized Controlled Trial by Qi et al. (From: Qi S, Yang E, Bao J, et al. J Endourol 2019;34:18-24; DOI: 10.1089/end.2019.0473).",,2020,,"['Renal Calculi', 'J Endourol 2019']",['Editorial Comment on:  Single-Use Versus Reusable Digital Flexible Ureteroscopes'],[],"[{'cui': 'C0022650', 'cui_str': 'Kidney Stones'}]","[{'cui': 'C0282411', 'cui_str': 'Commentary'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0392306', 'cui_str': 'Flexible ureteroscope (physical object)'}]",[],,0.0309851,,"[{'ForeName': 'Ben H', 'Initials': 'BH', 'LastName': 'Chew', 'Affiliation': 'Urologic Sciences, University of British Columbia, Vancouver, Canada.'}]",Journal of endourology,['10.1089/end.2019.0727']
482,31650853,Peri-Calculus Ureteral Thickness on Computed Tomography Predicts Stone Impaction at Time of Surgery: A Prospective Study.,"Introduction and Objectives:  Ureteroscopic management of impacted ureteral stones poses multiple challenges. We examined whether ureteral thickness measured on preoperative noncontrast computed tomography (CT) is predictive of stone impaction at the time of ureteroscopy (URS).  Methods:  Thirty-eight patients with preoperative CT scan and undergoing URS for ureteral stones were prospectively studied. Ureteral thickness directly above, around (peri-calculus ureteral thickness [P-CUT]), and below the calculus were determined on CT scan. The cross-sectional surface area around the stone (P-CUT) was also calculated. Stones were considered impacted at surgery if contrast had difficulty passing, a guidewire could not pass, and the stone was visually impacted >5 on a Likert scale. The surgeon determining intraoperative impaction and the individual measuring the ureteral thickness on CT were blinded.  Results:  Fourteen of the 38 patients were found to have an impacted ureteral stone at the time of surgery. Patients with an intraoperative finding of an impacted stone had significantly higher ureteral thickness above, around (P-CUT), below the calculus, and P-CUT surface area with all four  p -values <0.001. P-CUT surface area was independently predictive of impaction at the time of surgery on multivariate analysis. A mean P-CUT of 6.1 and 1.6 mm and P-CUT surface area of 92.6 and 15.4 mm 2  were noted for the impacted and nonimpacted stones, respectively.  Conclusion:  Ureteral thicknesses above, around (P-CUT), and below the calculus are readily measurable on CT scan. P-CUT surface area can also be calculated for a stronger representation of ureteral thickness. These four parameters are predictive of ureteral stone impaction and useful for surgical planning and patient counseling.",2020,P-CUT surface area was independently predictive of impaction at the time of surgery on multivariate analysis.,"['Thirty-eight patients with preoperative CT scan and undergoing URS for ureteral stones', 'Fourteen of the 38 patients were found to have an impacted ureteral stone at the time of surgery']",['ureteral thickness measured on preoperative noncontrast computed tomography (CT'],"['ureteral stone impaction', 'ureteral thickness']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}, {'cui': 'C0333124', 'cui_str': 'Impaction (morphologic abnormality)'}]",38.0,0.0162309,P-CUT surface area was independently predictive of impaction at the time of surgery on multivariate analysis.,"[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Chandhoke', 'Affiliation': 'Department of Urology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Jacob N', 'Initials': 'JN', 'LastName': 'Bamberger', 'Affiliation': 'Department of Urology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Gallante', 'Affiliation': 'Department of Urology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Atallah', 'Affiliation': 'Department of Urology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Mantu', 'Initials': 'M', 'LastName': 'Gupta', 'Affiliation': 'Department of Urology, Icahn School of Medicine at Mount Sinai, New York, New York.'}]",Journal of endourology,['10.1089/end.2019.0449']
483,31282392,The immediate effect of neurodynamic techniques on jumping performance: A randomised double-blind study.,"BACKGROUND AND OBJECTIVES


Neurodynamic techniques are used to restore neural functions. However, there are few studies about the effects on performance. The aim of this study was to investigate the immediate effects on vertical jumping (VJ) and horizontal jumping (HJ) of 2 different tension loading techniques applied to young adults.
MATERIAL AND METHOD


In this randomised double-blind study, a total of 68 participants with a mean age of 21.31 ± 1.21 years were separated into 2 groups using the closed envelope system: the femoral nerve mobilization (FNM) group and the sciatic nerve mobilization (SNM) group. The FNM and SNM techniques were applied as 2 seconds stretching with 2 seconds resting for 10 repetitions. The VJ and HJ performance of the participants was evaluated before and after the interventions by a researcher blinded to the groups.
RESULTS


The mean VJ performance before and after interventions was measured as 34.56 ± 7.80 cm and 35.89 ± 8.15 cm in the FNM group (p< 0.05) and 31.74 ± 8.31 cm and 32.76 ± 8.45 cm in the SNM group (p< 0.05). The effects of the techniques on HJ performance were not statistically significant (p> 0.05). There was no superiority between the techniques (p> 0.05).
CONCLUSION


The neurodynamic techniques were found to provide an immediate increase in VJ performance. Neurodynamic techniques are generally used in patient populations to improve treatment outcomes. According to these study results, neurodynamic techniques can be safely used to provide an immediate increase in performances of individuals with no lower extremity problems.",2020,"There was no superiority between the techniques (p> 0.05).
","['young adults', '68 participants with a mean age of 21.31 ± 1.21 years']","['closed envelope system: the femoral nerve mobilization (FNM) group and the sciatic nerve mobilization (SNM', 'vertical jumping (VJ) and horizontal jumping (HJ) of 2 different tension loading techniques', 'neurodynamic techniques']","['mean VJ performance', 'HJ performance', 'VJ and HJ performance', 'VJ performance']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0015808', 'cui_str': 'Femoral Nerve'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036394', 'cui_str': 'Sciatic Nerve'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",68.0,0.0448968,"There was no superiority between the techniques (p> 0.05).
","[{'ForeName': 'Cihan C', 'Initials': 'CC', 'LastName': 'Aksoy', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Health Sciences Faculty, Kutahya Health Science University, Evliya Celebi Campus, 43444 Kutahya, Turkey.'}, {'ForeName': 'Vedat', 'Initials': 'V', 'LastName': 'Kurt', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Health Sciences Faculty, Kutahya Health Science University, Evliya Celebi Campus, 43444 Kutahya, Turkey.'}, {'ForeName': 'İsmail', 'Initials': 'İ', 'LastName': 'Okur', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Health Sciences Faculty, Kutahya Health Science University, Evliya Celebi Campus, 43444 Kutahya, Turkey.'}, {'ForeName': 'Ferruh', 'Initials': 'F', 'LastName': 'Taspınar', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Health Sciences Faculty, Izmir Democracy University, Izmir, Turkey.'}, {'ForeName': 'Betül', 'Initials': 'B', 'LastName': 'Taspinar', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Health Sciences Faculty, Izmir Democracy University, Izmir, Turkey.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-170878']
484,31968988,Effect of electroacupuncture on sedation requirements during colonoscopy: a prospective placebo-controlled randomised trial.,"INTRODUCTION


Propofol provides excellent sedation during colonoscopy. However, its application, namely when used together with an opioid, is associated with cardiopulmonary depression. Acupuncture is used nowadays for the treatment of pain and anxiety, and also to induce sedation. We hypothesised that electroacupuncture (EA) during colonoscopy would have sedative effects, thereby reducing propofol requirements to achieve an adequate level of sedation.
METHOD


The study was designed and conducted as a single centre, patient and observer blinded, sham- and placebo-controlled randomised trial. Patients scheduled for elective colonoscopy under deep propofol/alfentanil sedation were randomly assigned to receive unilateral EA, sham-acupuncture (SA) or placebo-acupuncture (PA) at ST36, PC6 and LI4. The primary outcome parameter was the total dosage of propofol. Secondary outcomes included the patients' and endoscopists' satisfaction levels evaluated by questionnaires.
RESULTS


The dosage of propofol required (median [IQR]) was not significantly different between the three groups (EA group 147 μg/kg/min [109-193] vs SA group 141 μg/kg/min [123- 180] vs PA group 141 μg/kg/min [112-182]; P=0.776). There was also no significant difference in alfentanil consumption (P=0.634). Global satisfaction (median [IQR]) among patients (EA group 6.6 [6.0-7.0] vs SA group 6.8 [6.0-7.0] vs PA group 6.5 [6.0-7.0]; P=0.481) and endoscopists (6.0 [5.0-6.0] for all groups; P=0.773) did not significantly differ between the three groups. There was no significant difference in the number of cardiorespiratory events.
CONCLUSION


For colonoscopy, the applied mode of EA did not show any propofol-sparing sedative effect compared with sham or placebo acupuncture.
TRIAL REGISTRATION


The trial is registered in the Netherland's Trial Registry (NTR4325).",2020,The dosage of propofol required (median [IQR]) was not significantly different between the three groups (EA group 147 μg/kg/min [109-193] vs SA group 141 μg/kg/min [123- 180] vs PA group 141 μg/kg/min [112-182]; P=0.776).,"['Patients scheduled for elective colonoscopy under deep propofol/alfentanil sedation', 'colonoscopy']","['For colonoscopy', 'Acupuncture', 'placebo', 'unilateral EA, sham-acupuncture (SA) or placebo-acupuncture (PA) at ST36, PC6 and LI4', 'propofol', 'electroacupuncture (EA', 'Propofol', 'electroacupuncture', 'placebo acupuncture']","['number of cardiorespiratory events', 'pain and anxiety', 'total dosage of propofol', 'Global satisfaction', 'sedation requirements', 'alfentanil consumption', ""patients' and endoscopists' satisfaction levels evaluated by questionnaires""]","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002026', 'cui_str': 'Alfentanil'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]","[{'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0450533', 'cui_str': 'ST36 (body structure)'}, {'cui': 'C0450694', 'cui_str': 'PC6 (body structure)'}, {'cui': 'C0450480', 'cui_str': 'LI4 (body structure)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0002026', 'cui_str': 'Alfentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.381199,The dosage of propofol required (median [IQR]) was not significantly different between the three groups (EA group 147 μg/kg/min [109-193] vs SA group 141 μg/kg/min [123- 180] vs PA group 141 μg/kg/min [112-182]; P=0.776).,"[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Eberl', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Monteiro de Olivera', 'Affiliation': 'Department of Anesthesiology, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Bourne', 'Affiliation': 'University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Streitberger', 'Affiliation': 'Department of Anesthesiology and Pain Therapy, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Fockens', 'Affiliation': 'Department of Gastroenterology & Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Hollmann', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Preckel', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1136/acupmed-2017-011459']
485,31969287,The effect of Xuefu Zhuyu decoction on clopidogrel resistance and its association with the P2Y12 Gene polymorphisms and promoter DNA methylation.,"Some patients experience lesser degrees of platelet inhibition, which is known as clopidogrel resistance (CR). The goal of our study was to investigate the effects of Xuefu Zhuyu decoction on CR in coronary artery disease patients and whether P2Y12 polymorphisms and its methylation were related to drug response or not. 49 patients diagnosed with CR were randomly divided into control and treatment groups. Platelet functions were measured using Verify-Now P2Y12 assay. By restriction fragment length polymorphism-polymerase chain reaction, the single-nucleotide polymorphisms of rs2046934 and rs6785930 were genotyped. Using bisulphite pyrosequencing assay, we investigated the association of the P2Y12 gene DNA methylation levels and the effects of Xuefu Zhuyu decoction on CR. The results showed that the decoction improved CR (P=0.005), and the patients with the TT genotype in rs2046934 received substantial benefits from Xuefu Zhuyu Decoction, in both P2Y12 reaction units (PRU) and inhibition percentage (PPRU= 0.016; P inhibition percentage  = 0.028). And patients with lower methylation levels of CpG1 were more likely to be TT carriers in rs2046934 (CpG1 TT  Vs. CpG1 TC+CC  (%): 39.47±6.20 vs.45.70±8.47, P=0.044). In conclusion, our study indicated that Xuefu Zhuyu decoction might be useful for overcoming CR and the polymorphism of rs2046934 might influence the drug effect.",2019,"The results showed that the decoction improved CR (P=0.005), and the patients with the TT genotype in rs2046934 received substantial benefits from Xuefu Zhuyu Decoction, in both P2Y12 reaction units (PRU) and inhibition percentage (PPRU= 0.016; P inhibition percentage  = 0.028).","['49 patients diagnosed with CR', 'coronary artery disease patients']",['Xuefu Zhuyu decoction'],"['CR', 'Platelet functions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C1956470', 'cui_str': 'Xuefu Zhuyu'}]","[{'cui': 'C1254881', 'cui_str': 'Platelet function'}]",49.0,0.0341603,"The results showed that the decoction improved CR (P=0.005), and the patients with the TT genotype in rs2046934 received substantial benefits from Xuefu Zhuyu Decoction, in both P2Y12 reaction units (PRU) and inhibition percentage (PPRU= 0.016; P inhibition percentage  = 0.028).","[{'ForeName': 'Qinglin', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': ""Department of Traditional Chinese Internal Medicine, Ningbo No.1 Hospital, Ningbo, Zhejiang Province, People's Republic of China.""}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Su', 'Affiliation': ""Department of Gerontology, Ningbo No.1 Hospital, Ningbo, Zhejiang Province, People's Republic of China.""}, {'ForeName': 'Keqi', 'Initials': 'K', 'LastName': 'Zhu', 'Affiliation': ""Department of Traditional Chinese Internal Medicine, Ningbo No.1 Hospital, Ningbo, Zhejiang Province, People's Republic of China.""}, {'ForeName': 'Shujun', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Department of Hematology, Ningbo No.1 Hospital, Ningbo, Zhejiang Province, People's Republic of China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': ""Department of Anaesthesia, Ningbo No.1 Hospital, Ningbo, Zhejiang Province, People's Republic of China.""}, {'ForeName': 'Jingbo', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': ""Department of Gerontology, Ningbo No.1 Hospital, Ningbo, Zhejiang Province, People's Republic of China.""}]",Pakistan journal of pharmaceutical sciences,[]
486,31969307,Rosuvastatin pharmacokinetics in Pakistani healthy volunteers in comparison with other population.,"In current study, the pharmacokinetics (PK) of rosuvastatin were evaluated in Pakistani healthy volunteers and compared with those reported in other population. This was a randomized and open labeled clinical trial in which a single oral dose of 40 mg rosuvastatin was administered to the overnight fasted healthy volunteers. Plasma concentrations of rosuvastatin were quantified by a validated liquid chromatography-tandem mass spectrometry method. The PK parameters of rosuvastatin and its metabolite N-desmethyl-rosuvastatin were determined by PK specific software i.e., PK-Summit® (PK-Solutions). A total of 20 healthy volunteers having BMI in the normal ranges were included in this study. All PK parameters were represented as mean ± SD and 95% confidence intervals of the means have been calculated. The Cmax (29.07 ± 6.88 ng/mL), [AUC] x o  (206.65 ± 55.27 ng/hr/mL) and CL/F (3275.26 ± 1072.87 mL/hr) were slightly higher in our study, whereas the values of Vd (19377.23 ± 9114.29 mL) and t max  (3.0 ± 0.46 hr) were comparatively smaller. Overall, the PK parameters of rosuvastatin determined in our study were in compliance with other reported. Therefore, no adjustments in the dosing schedule or dose are warranted.",2019,"The Cmax (29.07 ± 6.88 ng/mL), [AUC] x o  (206.65 ± 55.27","['overnight fasted healthy volunteers', 'Pakistani healthy volunteers in comparison with other population', 'Pakistani healthy volunteers', '20 healthy volunteers having BMI in the normal ranges']","['rosuvastatin and its metabolite N-desmethyl-rosuvastatin', 'Rosuvastatin pharmacokinetics', 'rosuvastatin']",['Plasma concentrations of rosuvastatin'],"[{'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0337814', 'cui_str': 'Pakistani (Urduspeakers) (ethnic group)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086715', 'cui_str': 'Normal Range'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]",20.0,0.024009,"The Cmax (29.07 ± 6.88 ng/mL), [AUC] x o  (206.65 ± 55.27","[{'ForeName': 'Yasar', 'Initials': 'Y', 'LastName': 'Shah', 'Affiliation': 'Department of Pharmacy, Abdul Wali Khan University Mardan, Mardan, KPK, Pakistan.'}, {'ForeName': 'Zafar', 'Initials': 'Z', 'LastName': 'Iqbal', 'Affiliation': 'Department of Pharmacy, University of Peshawar, Peshawar, KPK, Pakistan.'}, {'ForeName': 'Lateef', 'Initials': 'L', 'LastName': 'Ahmad', 'Affiliation': 'Department of Pharmacy, University of Swabi, Swabi, KPK, Pakistan.'}, {'ForeName': 'Fazli', 'Initials': 'F', 'LastName': 'Khuda', 'Affiliation': 'Department of Pharmacy, University of Peshawar, Peshawar, KPK, Pakistan.'}, {'ForeName': 'Abad', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Department of Pharmacy, University of Swabi, Swabi, KPK, Pakistan.'}, {'ForeName': '-', 'Initials': '-', 'LastName': 'Ismail', 'Affiliation': 'Department of Pharmacy, University of Swabi, Swabi, KPK, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Hassan', 'Affiliation': 'Department of Pharmacy, University of Peshawar, Peshawar, KPK, Pakistan.'}, {'ForeName': 'Zaki-', 'Initials': 'Z', 'LastName': 'Ullah', 'Affiliation': 'Department of Pharmacy, University of Peshawar, Peshawar, KPK, Pakistan.'}]",Pakistan journal of pharmaceutical sciences,[]
487,30577714,"The Faith, Activity, and Nutrition (FAN) Dissemination and Implementation Study, Phase 1: Implementation Monitoring Methods and Results.","Faith-based settings offer opportunities for reaching populations at risk for chronic conditions and are optimal settings for dissemination and implementation (D&I) research. Faith, Activity, and Nutrition (FAN) is an evidence-based program designed to promote physical activity (PA) and healthy eating (HE) through church policy, systems, and environmental change. We report implementation fidelity for Phase 1 of the FAN D&I project, a countywide effort. The group randomized study included pre- and postintervention assessments of core PA and HE components. We compared implementation in early intervention ( n = 35) versus delayed intervention (control, n = 19) churches; assessed individual church implementation; and examined the effects of level of implementation on church member outcomes. Implementation assessments were conducted with the FAN coordinator via telephone survey. Study outcomes were assessed with church members 8 to 12 months following baseline assessment via self-administered surveys. We found significantly higher levels of implementation for PA opportunities, PA and HE guidelines, PA and HE messages, and PA and HE pastor support in intervention versus control churches and showed church-level variation in PA and HE implementation. PA self-efficacy varied by level of implementation; high and low implementers did not differ in proportion of church members physically inactive, although low implementers had fewer members inactive than controls. The high level of implementation in intervention churches shows promise for broader dissemination of FAN.",2019,"PA self-efficacy varied by level of implementation; high and low implementers did not differ in proportion of church members physically inactive, although low implementers had fewer members inactive than controls.",[],"['delayed intervention (control, n = 19) churches; assessed individual church implementation']","['Faith, Activity, and Nutrition (FAN', 'PA self-efficacy', 'Faith, Activity, and Nutrition (FAN) Dissemination']",[],"[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0562324', 'cui_str': 'Church (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0441039', 'cui_str': 'Fan (physical object)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0329002,"PA self-efficacy varied by level of implementation; high and low implementers did not differ in proportion of church members physically inactive, although low implementers had fewer members inactive than controls.","[{'ForeName': 'Ruth P', 'Initials': 'RP', 'LastName': 'Saunders', 'Affiliation': '1 University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wilcox', 'Affiliation': '1 University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Jake-Schoffman', 'Affiliation': '2 University of Massachusetts Medical School, Worcester, MA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Kinnard', 'Affiliation': '1 University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Hutto', 'Affiliation': '1 University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Forthofer', 'Affiliation': '3 University of North Carolina at Charlotte, Charlotte, NC, USA.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Kaczynski', 'Affiliation': '1 University of South Carolina, Columbia, SC, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198118818235']
488,31033457,Do the exercises performed with a theraband have an effect on knee muscle strength balances?,"BACKGROUND


In the current literature, exercises performed using fitness equipment and body weight have been used in order to decrease the bilateral deficit (BLD) and increase the hamstring-quadriceps (H/Q) ratio. No studies have previously investigated the effect of therabands, which are both portable and practical to be used anywhere, in regard to the BLD and H/Q ratio.
OBJECTIVES


The purpose of this study was to investigate the effect of several 10-week lower extremity exercises performed through therabands on the BLD and H/Q ratio.
METHODS


Twenty-seven voluntary male soccer players participated in the study. The players were categorized into the control group (CG) (n= 14) and the theraband exercise group (TBG) (n= 13). Theraband exercises for the lower extremity were performed by the soccer players in the TBG for four days every week over a 10-week period. The dominant (D) and non-dominant (ND) leg concentric extension and flexion of the soccer players were determined through an isokinetic dynamometer at 30∘s-1 and 240∘s-1 angular velocities. The data were analyzed through SPSS 24. To determine the difference between the BLD, H/Q ratios, and pre- and post-test of peak torque (PT), the Wilcoxon test was employed.
RESULTS


As a result of the analysis, it was found that the BLD for the TBG decreased, which was statistically significant (p< 0.05), whereas there were no statistically significant differences for the H/Q ratio for both the CG and TBG; the D and ND leg H/Q rate of the TBG at 240∘s-1 angular velocity increased in the post-test.
CONCLUSIONS


It was found that the exercises performed with the theraband were extremely efficient at increasing the PT and decreasing the BLD.",2020,It was found that the exercises performed with the theraband were extremely efficient at increasing the PT and decreasing the BLD.,['Twenty-seven voluntary male soccer players participated in the study'],"['theraband exercise group (TBG', 'Theraband exercises']","['BLD, H/Q ratios, and pre- and post-test of peak torque (PT', 'knee muscle strength balances', 'TBG', 'bilateral deficit (BLD', 'D and ND leg H/Q rate of the TBG at 240∘s-1 angular velocity', 'H/Q ratio']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0337445', 'cui_str': 'Thyroglobulin measurement (procedure)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0337445', 'cui_str': 'Thyroglobulin measurement (procedure)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}]",27.0,0.0173447,It was found that the exercises performed with the theraband were extremely efficient at increasing the PT and decreasing the BLD.,"[{'ForeName': 'Zait Burak', 'Initials': 'ZB', 'LastName': 'Aktug', 'Affiliation': ''}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181217']
489,31268872,Allopurinol treatment adversely impacts left ventricular mass regression in patients with well-controlled hypertension.,"OBJECTIVES


Previous studies have demonstrated that high-dose allopurinol is able to regress left ventricular (LV) mass in cohorts with established cardiovascular disease. The aim of this study was to assess whether treatment with high-dose allopurinol would regress LV mass in a cohort with essential hypertension, LV hypertrophy and well-controlled blood pressure but without established cardiovascular disease.
METHODS


We conducted a mechanistic proof-of-concept randomized, placebo-controlled, double-blind trial of allopurinol (600 mg/day) versus placebo on LV mass regression. Duration of treatment was 12 months. LV mass regression was assessed by Cardiac Magnetic Resonance. Secondary outcomes were changes in endothelial function (flow-mediated dilatation), arterial stiffness (pulse wave velocity) and biomarkers of oxidative stress.
RESULTS


Seventy-two patients were randomized into the trial. Mean baseline urate was 362.2 ± 96.7 μmol/l. Despite good blood pressure control, LV mass regression was significantly reduced in the allopurinol cohort compared with placebo (LV mass -0.37 ± 6.08 versus -3.75 ± 3.89 g; P = 0.012). Oxidative stress markers (thiobarbituric acid reactive substances) were significantly higher in the allopurinol group versus placebo (0.26 ± 0.85 versus -0.34 ± 0.83 μmol/l; P = 0.007). Other markers of vascular function were not significantly different between the two groups.
CONCLUSION


Treatment with high-dose allopurinol in normouricemic controlled hypertensive patients and LV hypertrophy is detrimental. It results in reduced LV mass regression and increased oxidative stress over a 12-month period. This may be because of an adverse impact on redox balance. Cohort selection for future cardiovascular trials with allopurinol is crucial.",2019,Oxidative stress markers (thiobarbituric acid reactive substances) were significantly higher in the allopurinol group versus placebo (0.26 ± 0.85 versus -0.34 ± 0.83 μmol/l; P = 0.007).,"['normouricemic controlled hypertensive patients', 'patients with well-controlled hypertension', 'Seventy-two patients']","['Allopurinol', 'allopurinol', 'placebo']","['oxidative stress', 'blood pressure control, LV mass regression', 'vascular function', 'changes in endothelial function (flow-mediated dilatation), arterial stiffness (pulse wave velocity) and biomarkers of oxidative stress', 'Oxidative stress markers (thiobarbituric acid reactive substances']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}]","[{'cui': 'C0002144', 'cui_str': 'Allopurinol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}]",72.0,0.657091,Oxidative stress markers (thiobarbituric acid reactive substances) were significantly higher in the allopurinol group versus placebo (0.26 ± 0.85 versus -0.34 ± 0.83 μmol/l; P = 0.007).,"[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Gingles', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Symon', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Gandy', 'Affiliation': 'Department of Clinical Radiology.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Struthers', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Houston', 'Affiliation': 'Department of Clinical Radiology.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'MacDonald', 'Affiliation': 'MEMO and Hypertension Research Centre, University of Dundee, Dundee, UK.'}, {'ForeName': 'Chim C', 'Initials': 'CC', 'LastName': 'Lang', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee.'}, {'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Donnan', 'Affiliation': 'Population Health Sciences Division.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee.'}]",Journal of hypertension,['10.1097/HJH.0000000000002189']
490,31537115,Comparison of Miniaturized Percutaneous Nephrolithotomy and Standard Percutaneous Nephrolithotomy in Secondary Patients: A Randomized Prospective Study.,"Aim:  We aimed to compare the efficacy and safety of mini-percutaneous nephrolithotomy (mPNL) and standard PNL (sPNL) in a group of patients who had a history of PNL and/or open renal surgery (secondary patients).  Materials and Methods:  The study included 148 patients who underwent secondary PNL between November 2016 and September 2018. The patients with kidney stone ≥2 cm were included in the study. Patients were randomly divided into two groups as mPNL and sPNL. For both groups, demographic data, stone characteristics, and operative and postoperative data were recorded prospectively. Data were analyzed at 95% confidence interval and considered significant when  p  value was <0.05.  Results:  A total of 148 (76 mPNL, 72 sPNL) patients with a history of PNL and/or open surgery were included in the study. The mean duration of operation was longer in mPNL (106.9  vs  91.2 minutes,  p  = 0.016). The mean duration of fluoroscopy in mPNL was shorter (4.4  vs  5.3 minutes,  p  = 0.021). The tubeless procedure was higher in the mPNL (21.1%  vs  2.8%,  p  = 0.001). The hemoglobin drop was less in mPNL (0.7  vs  1.4 g/dL,  p  = 0.011). Duration of nephrostomy and hospitalization was longer in sPNL ( p  = 0.001 and  p  = 0.005, respectively). The success rate in the mPNL group was higher compared with the sPNL group; however, this difference was statistically insignificant (75.0%  vs  72.2%,  p  = 0.558).  Conclusion:  mPNL is superior to sPNL in terms of hemoglobin drop, duration of fluoroscopy, applicability of a tubeless procedure, and duration of nephrostomy and hospitalization among secondary patients. Duration of operation was found to be longer for mPNL. Success rate was higher in the mPNL group, although not statistically significant.",2020,"mPNL is superior to standard PNL in terms of hemoglobin drop, duration of fluoroscopy, applicability of a tubeless procedure and duration of nephrostomy and hospitalization among secondary patients.","['patients who had history of PNL and/or open renal surgery (secondary patients', 'patients with kidney stone≥ 2 cm were included in the study', '148 patients who underwent secondary PNL between November 2016 and September 2018', 'A total of 148 (76 mPNL, 72 sPNL) patients with a history of PNL and/or open surgery were included in the study']","['mini percutaneous nephrolithotomy (mPNL) and standard PNL', 'mPNL and sPNL']","['mean duration of operation', 'success rate', 'efficacy and safety', 'Success rate', 'mean duration of fluoroscopy in mPNL', 'Duration of nephrostomy and hospitalization', 'hemoglobin drop', 'tubeless procedure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0194053', 'cui_str': 'Kidney operation (procedure)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0348025', 'cui_str': 'Open approach - access (qualifier value)'}]","[{'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0278314', 'cui_str': 'Nephrostomy'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]",148.0,0.0251852,"mPNL is superior to standard PNL in terms of hemoglobin drop, duration of fluoroscopy, applicability of a tubeless procedure and duration of nephrostomy and hospitalization among secondary patients.","[{'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Kandemir', 'Affiliation': 'Department of Urology, Kızıltepe State Hospital, Kızıltepe, Mardin, Turkey.'}, {'ForeName': 'Metin', 'Initials': 'M', 'LastName': 'Savun', 'Affiliation': 'Department of Urology, Siverek State Hospital, Siverek, Şanlıurfa, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sezer', 'Affiliation': 'Department of Pediatric Urology, Cerrahpasa Faculty of Medicine, İstanbul University, Fatih, İstanbul, Turkey.'}, {'ForeName': 'Akif', 'Initials': 'A', 'LastName': 'Erbin', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Fatih, İstanbul, Turkey.'}, {'ForeName': 'Mehmet Fatih', 'Initials': 'MF', 'LastName': 'Akbulut', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Fatih, İstanbul, Turkey.'}, {'ForeName': 'Ömer', 'Initials': 'Ö', 'LastName': 'Sarılar', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Fatih, İstanbul, Turkey.'}]",Journal of endourology,['10.1089/end.2019.0538']
491,31965170,Sensitivity of the Nipple-Areola Complex in Reduction Mammaplasty Following Periareolar Dermis Section.,"BACKGROUND


Preservation of the periareolar dermis, after de-epithelization in reduction mammaplasty, may result in reduced nipple-areola complex (NAC) mobility. Consequently, distortion in shape and difficulty correcting the areola position can occur.
OBJECTIVES


The aim of this study was to evaluate NAC viability and sensitivity resulting from periareolar dermis section after de-epithelization in patients who underwent reduction mammaplasty surgery.
METHODS


This study was a randomized, controlled double-blind clinical trial. A total of 41 patients (82 breasts) were randomly allocated into 2 groups and underwent reduction mammaplasty-involving the superior pedicle-with a final inverted T-shaped scar. A sectioning of the periareolar dermis was performed on the breasts in the experimental group. Semmes-Weinstein monofilaments were used to evaluate NAC sensitivity at the preoperative evaluation, and 3, 6, and 52 weeks after surgery.
RESULTS


No cases of partial or total NAC necrosis were noted in either group. The comparison between the groups did not show significant differences regarding NAC sensitivity. However, a statistically significant difference was noted when sensitivity levels at the preoperative evaluation and 3 weeks after surgery were compared in the experimental group. A significant difference was noted when the scores of the sensitivity 3 weeks after surgery were compared between the control and the experiment groups. Nevertheless, after 1 year, no statistical differences were observed in the experimental group or between both groups.
CONCLUSIONS


The sectioning of the periareolar dermis does not affect the viability or the pressure sensitivity of the NAC.
LEVEL OF EVIDENCE: 4


",2020,A significant difference was noted when the scores of the sensitivity three weeks after surgery were compared between the control and the experiment groups.,"['patients who underwent reduction mammaplasty surgery', '41 patients (82 breasts']",['reduction mammaplasty - using the superior pedicle - with a final inverted T-shaped scar'],"['NAC sensitivity', 'partial or total NAC necrosis', 'sensitivity levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0191922', 'cui_str': 'Breast reduction'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0006141', 'cui_str': 'Breast'}]","[{'cui': 'C0191922', 'cui_str': 'Breast reduction'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0456605', 'cui_str': 'Pedicle (substance)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0439636', 'cui_str': 'Inverted-T (qualifier value)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}]","[{'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",41.0,0.0269908,A significant difference was noted when the scores of the sensitivity three weeks after surgery were compared between the control and the experiment groups.,"[{'ForeName': 'Jairo Zacchê', 'Initials': 'JZ', 'LastName': 'de Sá', 'Affiliation': 'Federal University of Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Antônio Carlos Côrte Real', 'Initials': 'ACCR', 'LastName': 'Braga', 'Affiliation': 'Federal University of Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Rafael Henrique Coutinho', 'Initials': 'RHC', 'LastName': 'Barreto', 'Affiliation': 'Federal University of Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Anderson da Silva', 'Initials': 'ADS', 'LastName': 'Ramos', 'Affiliation': 'Federal University of Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Amanda Estelita', 'Initials': 'AE', 'LastName': 'de Oliveira Rodrigues', 'Affiliation': 'Federal University of Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Santa-Cruz', 'Affiliation': 'Federal University of Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'José Lamartine de Andrade', 'Initials': 'JLA', 'LastName': 'Aguiar', 'Affiliation': 'Federal University of Pernambuco, Recife, PE, Brazil.'}]",Aesthetic surgery journal,['10.1093/asj/sjaa011']
492,31927346,Perceived stress mediates the effect of yoga on quality of life and disease activity in ulcerative colitis. Secondary analysis of a randomized controlled trial.,"OBJECTIVE


Yoga positively affects health-related quality of life and disease activity in ulcerative colitis. The underlying modes of action remain unclear. Within the present study we hypothesized that patients´ perceived stress mediates the effects of yoga on health-related quality of life and disease activity.
METHODS


This is a secondary analysis of a randomized controlled trial comparing the effects of yoga to written self-care advice in patients with inactive ulcerative colitis and impaired quality of life. Perceived stress was assessed using the Perceived Stress Questionnaire, health-related quality of life using the Inflammatory Bowel Disease Questionnaire and disease activity using the Clinical Activity Index. Outcomes were assessed at weeks 0, 12 and 24.
RESULTS


Seventy-seven patients participated. Thirty-nine patients attended the 12 supervised weekly yoga sessions (71.8% women; 45.0 ± 13.3 years) and 38 patients written self-care advice (78.9% women; 46.1 ± 10.4 years). Perceived stress correlated significantly with health-related quality of life and disease activity at week 24. Perceived stress at week 12 fully mediated the effects of yoga on health-related quality of life (B = 16.23; 95% Confidence interval [6.73; 28.40]) and disease activity (B = -0.28; 95% Confidence interval [-0.56; -0.06]) at week 24.
CONCLUSION


Our findings confirm the importance of perceived stress in reducing disease activity and increasing health-related quality of life in patients with ulcerative colitis and impaired quality of life. Practitioners should keep psychosocial risk in mind as a risk factor for disease exacerbation, and consider yoga as an adjunct intervention for highly stressed patients with ulcerative colitis. CLINICALTRIALS.
GOV REGISTRATION NUMBER


The trial was registered at clinicaltrials.gov prior to patient recruitment (registration number NCT02043600).",2020,Perceived stress at week 12 fully mediated the effects of yoga on health-related quality of life (B = 16.23; 95% Confidence interval [6.73; 28.40]) and disease activity (B = -0.28;,"['Seventy-seven patients participated', 'patients with ulcerative colitis', 'patients with inactive ulcerative colitis and impaired quality of life', 'highly stressed patients with ulcerative colitis', 'Thirty-nine patients attended the 12 supervised weekly yoga sessions (71.8% women; 45.0\xa0±\xa013.3\xa0years) and 38 patients written self-care advice (78.9% women; 46.1\xa0±\xa010.4\xa0years', 'ulcerative colitis']",['yoga to written self-care advice'],"['disease activity', 'health-related quality of life', 'health-related quality of life and disease activity', 'quality of life and disease activity', 'Perceived Stress Questionnaire, health-related quality of life using the Inflammatory Bowel Disease Questionnaire and disease activity using the Clinical Activity Index']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C4049260', 'cui_str': 'Impaired quality of life'}, {'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",77.0,0.136482,Perceived stress at week 12 fully mediated the effects of yoga on health-related quality of life (B = 16.23; 95% Confidence interval [6.73; 28.40]) and disease activity (B = -0.28;,"[{'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Koch', 'Affiliation': 'Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany. Electronic address: a.koch@kem-med.com.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Schöls', 'Affiliation': 'Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Jost', 'Initials': 'J', 'LastName': 'Langhorst', 'Affiliation': 'Department of Internal and Integrative Medicine, Klinikum Bamberg, Bamberg, Germany. Electronic address: Jost.Langhorst@sozialstiftung-bamberg.de.'}, {'ForeName': 'Gustav', 'Initials': 'G', 'LastName': 'Dobos', 'Affiliation': 'Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany. Electronic address: G.Dobos@kem-med.com.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Cramer', 'Affiliation': 'Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany. Electronic address: H.Cramer@kem-med.com.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2019.109917']
493,31961224,Response of Retinal Sensitivity to Intravitreal Anti-angiogenic Bevacizumab and Triamcinolone Acetonide for Patients with Diabetic Macular Edema over One Year.,"AIM


The aim of this study was to evaluate and compare microperimetry changes in patients with clinically significant diabetic macular edema secondary to diabetes mellitus, following intravitreal injections of bevacizumab or triamcinolone during a follow-up of 1 year after treatment.
MATERIALS AND METHODS


30 patients with clinically significant macular edema were randomized into two groups of 15 patients each. One group initially received three intravitreal injections of 2.5 mg bevacizumab at monthly intervals. The other received a single injection of 8 mg of triamcinolone followed by two sham interventions at monthly intervals. Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were measured. Macular function was documented by microperimetry at baseline, 3, 6, 9 months and at the last visit of each patient.
RESULTS


In the bevacizumab group, the mean differential light threshold (±standard deviation) under therapy improved significantly from 8.40 (± 3.8) dB to 12.8 (±4.3) dB at the 12-month follow-up visit (p ≤ .05), whereas in the triamcinolone group it increased from 8.0 (± 2.4) dB at baseline to 9.3 (±3.6) dB at the last visit without reaching statistical significance ( p  > .05). The mean differential light thresholds between the two groups were not statistically significant at baseline or the last visit ( p  > .05). In the bevacizumab group, the improvement (slope) in mean differential light threshold was significantly superior to the Triamcinolone group (Estimate = 0.588, p ≤ .05).
CONCLUSION


Central macular function as measured by microperimetry in patients with acute DME improved in addition to anatomical restoration after intravitreal bevacizumab and triamcinolone injection. In our clinical study, the measures of the variables in patients receiving bevacizumab were superior to those receiving triamcinolone throughout the one-year observation period.",2020,"In the bevacizumab group the improvement (slope) in mean differential light threshold was significantly superior to the Triamcinolone group (Estimate = 0.588, p≤0.05).","['patients with diabetic macular edema over one year', 'patients with clinically significant diabetic macular edema secondary to diabetes mellitus', 'patients with acute DME', '30 patients with clinically significant macular edema']","['triamcinolone', 'bevacizumab', 'triamcinolone injection', 'Triamcinolone', 'intravitreal anti-angiogenic bevacizumab and triamcinolone acetonide', 'bevacizumab or triamcinolone']","['Macular function', 'mean differential light thresholds', 'mean differential light threshold', 'mean differential light threshold (±standard deviation) under therapy', 'Best-corrected visual acuity (BCVA) and central retinal thickness (CRT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0730284', 'cui_str': 'Clinically significant macular edema (disorder)'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0641456', 'cui_str': 'DMES'}]","[{'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4529672', 'cui_str': 'Triamcinolone Injection [Zilretta]'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone Acetonide'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}]",30.0,0.0174961,"In the bevacizumab group the improvement (slope) in mean differential light threshold was significantly superior to the Triamcinolone group (Estimate = 0.588, p≤0.05).","[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Mylonas', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna , Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Schranz', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna , Vienna, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Scholda', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna , Vienna, Austria.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Karst', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna , Vienna, Austria.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Reiter', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna , Vienna, Austria.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Baumann', 'Affiliation': 'Center for Medical Statistics, Informatics and Intelligent Systems, Section for Medical Statistics, Medical University of Vienna , Vienna, Austria.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Schmidt-Erfurth', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna , Vienna, Austria.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kriechbaum', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna , Vienna, Austria.'}]",Current eye research,['10.1080/02713683.2020.1712728']
494,31960896,VYC-25L Hyaluronic Acid Injectable Gel Is Safe and Effective for Long-Term Restoration and Creation of Volume of the Lower Face.,"BACKGROUND


Juvéderm Volux (VYC-25L; Allergan plc) is an injectable hyaluronic acid gel designed to restore and create facial volume.
OBJECTIVE


The aim of this study was to evaluate the safety and effectiveness of Volux for chin retrusion over 18 months and after repeat treatment.
METHODS


This prospective, single-blind, controlled study enrolled subjects aged ≥18 years with chin retrusion (glabella-subnasale-pogonion facial angle 145°-165°). Subjects were randomized (3:1) to Volux at study onset or 3 months later (control group), and could receive a single repeat treatment during months 18 to 24. Assessments included mean facial-angle change from baseline, Global Aesthetic Improvement Scale (GAIS) responder rates (improved/much improved), improvements in 3 subject-reported FACE-Q scales, and safety.
RESULTS


Of 132 enrolled subjects, 119 received initial Volux treatment and 89 received repeat treatment. Mean changes (95% confidence interval) in glabella-subnasale-pogonion angle from baseline for treatment and control groups, respectively, were: 1.15° (0.75°, 1.56°) and 1.16° (0.57°, 1.75°) at month 18, and 3.14° (2.68°, 3.61°) and 2.72° (1.78°, 3.66°) 1 month after repeat treatment. Investigators rated 52.5%/60.0% of treated/control subjects at month 18 and 96.9%/100% after retreatment as GAIS responders; subject-reported rates were 62.0%/64.0% and 93.8%/100%. Durable improvements in Satisfaction with Chin, Satisfaction with Lower Face and Jawline, and Psychological Well-Being were reported in 82.1%, 78.2%, and 60.3% of subjects, respectively, at month 18, and 92.3%, 93.8%, and 67.7% of subjects after retreatment. The safety profile was as expected.
CONCLUSIONS


Volux injectable gel is a safe, effective, and durable alternative to surgical treatments for increasing chin projection and jaw volume, and results in high patient satisfaction.
LEVEL OF EVIDENCE: 2


",2020,"Durable improvements in Satisfaction with Chin, Satisfaction with Lower Face and Jawline, and Psychological Well-being were reported in 82.1%, 78.2%, and 60.3% of subjects, respectively, at month 18, and 92.3%, 93.8%, and 67.7% of subjects after retreatment.","['132 enrolled subjects, 119 received initial Volux treatment and 89 received repeat treatment', 'enrolled subjects aged ≥18 years with chin retrusion (glabella-subnasale-pogonion facial angle 145°-165°']",['VYC-25L Hyaluronic Acid Injectable Gel'],"['FACE-Q scales, and safety', 'Mean changes', 'Satisfaction with Chin, Satisfaction with Lower Face and Jawline, and Psychological Well-being', 'mean facial-angle change from baseline, Global Aesthetic Improvement Scale (GAIS) responder rates']","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008114', 'cui_str': 'Mentum'}, {'cui': 'C0222694', 'cui_str': 'Structure of glabella'}, {'cui': 'C2334731', 'cui_str': 'Cephalometric pogonion point'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}]","[{'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0222045'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0008114', 'cui_str': 'Mentum'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}]",132.0,0.0218295,"Durable improvements in Satisfaction with Chin, Satisfaction with Lower Face and Jawline, and Psychological Well-being were reported in 82.1%, 78.2%, and 60.3% of subjects, respectively, at month 18, and 92.3%, 93.8%, and 67.7% of subjects after retreatment.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Ogilvie', 'Affiliation': ''}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Benouaiche', 'Affiliation': ''}, {'ForeName': 'Wolfgang G', 'Initials': 'WG', 'LastName': 'Philipp-Dormston', 'Affiliation': ''}, {'ForeName': 'Lakhdar', 'Initials': 'L', 'LastName': 'Belhaouari', 'Affiliation': ''}, {'ForeName': 'Frodo', 'Initials': 'F', 'LastName': 'Gaymans', 'Affiliation': ''}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Sattler', 'Affiliation': ''}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Harvey', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Schumacher', 'Affiliation': ''}]",Aesthetic surgery journal,['10.1093/asj/sjaa013']
495,31868126,Persuasive Effects of Linguistic Agency Assignment and Linguistic Markers of Argumentation in Health Messages about an Emerging Sexually Transmitted Disease.,"Answering the call by some health communication researchers to give greater attention to message strategies at the level of word choices and sentence structures, this study examined how the linguistic marking of argumentative orientation and linguistic agency assignment affects young adults' reactions to an informational message about a sexually transmitted infection presented as a new emerging health threat. Participants were randomly assigned to read one of the four versions of a fact sheet defined by a 2 × 2 (agency assignment x marking of argumentation orientation) factorial design and thereafter completed a questionnaire. Results indicated that the assignment of agency to the virus (vs. human) increased the perceived severity of the health threat, perceived susceptibility to it, persuasiveness of the message, and safer sex intentions. The same outcomes occurred when the message was phrased with a high marking of the argumentative orientation rather than a low marking. These findings suggest that a better understanding of language variable effects can boost the efficacy of promotional health messages.",2020,"Results indicated that the assignment of agency to the virus (vs. human) increased the perceived severity of the health threat, perceived susceptibility to it, persuasiveness of the message, and safer sex intentions.",[],['Linguistic Agency Assignment and Linguistic Markers of Argumentation'],"['perceived severity of the health threat, perceived susceptibility to it, persuasiveness of the message, and safer sex intentions']",[],"[{'cui': 'C0023741', 'cui_str': 'Linguistics'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0597728', 'cui_str': 'Responsible Sex'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",,0.0274421,"Results indicated that the assignment of agency to the virus (vs. human) increased the perceived severity of the health threat, perceived susceptibility to it, persuasiveness of the message, and safer sex intentions.","[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Coppola', 'Affiliation': 'Department of Public Administration Management Studies, University Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'McGLONE', 'Affiliation': 'Department of Communication Studies, University of Texas at Austin, Austin, Texas, USA.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Girandola', 'Affiliation': 'Department of Psychology, University of Aix-Marseille, Aix-en-Provence, France.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Camus', 'Affiliation': 'Department of Psychology, University of Rouen, Mont Saint Aignan, France.'}]",Journal of health communication,['10.1080/10810730.2019.1697398']
496,31958976,Evaluating the Feasibility of Implementing an HIV Prevention Intervention for Incarcerated African American Men: Lessons Learned From a Pilot Study.,"This pilot study evaluated the feasibility of implementing an evidence-based, culturally adapted HIV intervention with substance-using African American men in a prison setting. We recruited 60, soon-to-be released African American male prisoners from a larger study ( N  = 211) to be randomly selected for participation in the group-based HIV intervention, Real Men Are Safe-Culturally Adapted (REMAS-CA). Participants who were not selected for participation in the intervention received standard Centers for Disease Control and Prevention HIV prevention counseling education, provided during participant assessment in the larger study. Nearly all of the participants who were selected to participate (87%) completed the REMAS-CA intervention. To examine feasibility, data were collected about any revisions made to the HIV intervention components for the prison setting, time needed to implement the program in full, details of implementing the intervention to ensure participation and maintain retention, and participant perception of the intervention. Revisions to the intervention included reducing the number of sessions from five to three, modifying the protocol language based on the setting, and removing six activities deemed inappropriate and/or unallowable by the prison officials. The cultural considerations and intervention, overall, were well received by the participants. However, several revisions made specific to the prison and its administration could affect the potential effectiveness of the intervention. Future research is needed to determine the effectiveness of REMAS-CA among this community.",2020,"This pilot study evaluated the feasibility of implementing an evidence-based, culturally adapted HIV intervention with substance-using African American men in a prison setting.","['We recruited 60, soon-to-be released African American male prisoners from a larger study ( N  = 211', 'African American men in a prison setting', 'Participants who were not selected for participation in the intervention received', 'Incarcerated African American Men']","['standard Centers for Disease Control and Prevention HIV prevention counseling education', 'HIV Prevention Intervention', 'HIV intervention, Real Men Are Safe-Culturally Adapted (REMAS-CA', 'REMAS-CA intervention']",[],"[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0036849', 'cui_str': 'Set'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007670', 'cui_str': 'CDC'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]",[],,0.0185619,"This pilot study evaluated the feasibility of implementing an evidence-based, culturally adapted HIV intervention with substance-using African American men in a prison setting.","[{'ForeName': 'Carlos C', 'Initials': 'CC', 'LastName': 'Mahaffey', 'Affiliation': 'Oklahoma State University, Stillwater, OK, USA.'}, {'ForeName': 'Danelle', 'Initials': 'D', 'LastName': 'Stevens-Watkins', 'Affiliation': 'University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'A Kathleen', 'Initials': 'AK', 'LastName': 'Burlew', 'Affiliation': 'University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Myles D', 'Initials': 'MD', 'LastName': 'Moody', 'Affiliation': 'University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Paris B', 'Initials': 'PB', 'LastName': 'Wheeler', 'Affiliation': 'University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Shawndaya', 'Initials': 'S', 'LastName': 'Thrasher', 'Affiliation': 'University of Kentucky, Lexington, KY, USA.'}]",Health promotion practice,['10.1177/1524839919896786']
497,31959014,Low- Versus Moderate-Sodium Diet in Patients With Recent Hospitalization for Heart Failure: The PROHIBIT (Prevent Adverse Outcomes in Heart Failure by Limiting Sodium) Pilot Study.,"BACKGROUND


We conducted a pilot study to assess feasibility, on-study retention, trends in natriuretic peptide levels, quality of life, and safety of a 12-week feeding trial with 1500- versus 3000-mg daily sodium meals in high-risk patients with heart failure.
METHODS


Of 196 patients with recent (≤2 weeks) hospitalization for heart failure, ejection fraction ≤40%, on optimal medical therapy, functionally independent, and able to communicate, 83 (47%) consented to participate. Of these, 27 (age, 62±11 years; 22 men; 20 white; ejection fraction, 26±8%) had 24-hour urine sodium ≥3000 mg and agreed to randomly receive either 1500-mg (N=12) or 3000-mg (N=15) sodium meals.
RESULTS


On-study retention at 12 weeks was 77% (82% versus 73%;  P =0.53); 6 patients (2 in 1500-mg, 4 in 3000-mg arm) withdrew before study completion. Food satisfaction questionnaires indicated that both diets were well tolerated. Quality of life improved in the 1500-mg arm at 12 weeks but did not change in the 3000-mg arm. Average compliance with meals was 52% (based on urinary sodium) and was not significantly different between arms (42% versus 60%;  P =0.25). Study meals reduced 24-hour urinary sodium by 137±21 mmol (1500-mg arm) and 82±16 mmol (3000-mg arm), both  P <0.001; between-arms difference was 55 mmol (95% CI, 3-107;  P =0.037). NT-proBNP (N-terminal pro-B-type natriuretic peptide) was not affected. Hospitalizations and low blood pressure events did not differ significantly between arms. Serum creatinine decreased more (by 0.17 mg/dL [95% CI, 0.06-0.28];  P =0.003) in the 1500-mg arm. Creatinine increases >0.5 mg/dL over baseline only occurred in 1 patient in the 3000-mg arm.
CONCLUSIONS


Even with prepared meals, investigating optimal dietary sodium in heart failure comes with challenges, including need for extensive screening, reluctance to participate, and compliance issues. Because both diets reduced urinary sodium without adverse safety or quality of life signals, a larger trial, with modifications to improve participation and compliance, would be ethical and feasible.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT02467296.",2020,Quality of life improved in the 1500-mg arm at 12 weeks but did not change in the 3000-mg arm.,"['Of 196 patients with recent (≤2 weeks) hospitalization for heart failure, ejection fraction ≤40%, on optimal medical therapy, functionally independent, and able to communicate, 83 (47%) consented to participate', 'Patients', '27 (age, 62±11 years; 22 men; 20 white; ejection fraction, 26±8%) had 24-hour urine sodium ≥3000 mg and agreed to randomly receive either 1500-mg (N=12) or 3000-mg (N=15', 'high-risk patients with heart failure']","['Low', '1500- versus 3000-mg daily sodium meals', 'sodium meals', 'NT-proBNP', 'Moderate-Sodium Diet']","['Average compliance with meals', 'Serum creatinine', 'natriuretic peptide levels, quality of life, and safety', 'Creatinine', 'tolerated', 'Quality of life', '24-hour urinary sodium', 'Food satisfaction questionnaires', 'Hospitalizations and low blood pressure events']","[{'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C4273559', 'cui_str': 'Functionally independent'}, {'cui': 'C2364293', 'cui_str': 'Able to communicate (finding)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1256585', 'cui_str': 'Sodium measurement, urine (procedure)'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0470279', 'cui_str': 'Three thousand'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0470279', 'cui_str': 'Three thousand'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0301592', 'cui_str': 'Sodium diet (finding)'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",196.0,0.0541266,Quality of life improved in the 1500-mg arm at 12 weeks but did not change in the 3000-mg arm.,"[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kalogeropoulos', 'Affiliation': 'Division of Cardiology, Department of Medicine, Stony Brook University, NY (A.K., L.P., H.S.).'}, {'ForeName': 'Lampros', 'Initials': 'L', 'LastName': 'Papadimitriou', 'Affiliation': 'Division of Cardiology, Department of Medicine, Stony Brook University, NY (A.K., L.P., H.S.).'}, {'ForeName': 'Vasiliki V', 'Initials': 'VV', 'LastName': 'Georgiopoulou', 'Affiliation': 'Department of Medicine (V.V.G.), Emory University, Atlanta, GA.'}, {'ForeName': 'Sandra B', 'Initials': 'SB', 'LastName': 'Dunbar', 'Affiliation': 'School of Nursing (S.B.D.), Emory University, Atlanta, GA.'}, {'ForeName': 'Hal', 'Initials': 'H', 'LastName': 'Skopicki', 'Affiliation': 'Division of Cardiology, Department of Medicine, Stony Brook University, NY (A.K., L.P., H.S.).'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi, Jackson (L.P., J.B.).'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.119.006389']
498,31726194,"Prior Heart Failure Hospitalization, Clinical Outcomes, and Response to Sacubitril/Valsartan Compared With Valsartan in HFpEF.","BACKGROUND


The period shortly after hospitalization for heart failure (HF) represents a high-risk window for recurrent clinical events, including rehospitalization or death.
OBJECTIVES


This study sought to determine whether the efficacy and safety of sacubitril/valsartan varies in relation to the proximity to hospitalization for HF among patients with HF with preserved ejection fraction (HFpEF).
METHODS


In this post hoc analysis of PARAGON-HF (Prospective Comparison of ARNI [Angiotensin Receptor-Neprilysin Inhibitor] with ARB [Angiotensin Receptor Blocker] Global Outcomes in HFpEF), we assessed the risk of clinical events and response to sacubitril/valsartan in relation to time from last HF hospitalization among patients with HFpEF (≥45%). The primary outcome was composite total HF hospitalizations and cardiovascular death, analyzed by using a semiparametric proportional rates method, stratified by geographic region.
RESULTS


Of 4,796 validly randomized patients in PARAGON-HF, 622 (13%) were screened during hospitalization or within 30 days of prior hospitalization, 555 (12%) within 31 to 90 days, 435 (9%) within 91 to 180 days, and 694 (14%) after 180 days; 2,490 (52%) were never previously hospitalized. Over a median follow-up of 35 months, risk of total HF hospitalizations and cardiovascular death was inversely and nonlinearly associated with timing from prior HF hospitalization (p < 0.001). There was a gradient in relative risk reduction in primary events with sacubitril/valsartan from patients hospitalized within 30 days (rate ratio: 0.73; 95% confidence interval: 0.53 to 0.99) to patients never hospitalized (rate ratio: 1.00; 95% confidence interval: 0.80 to 1.24; trend in relative risk reduction: p interaction  = 0.15). With valsartan alone, the rate of total primary events was 26.7 (≤30 days), 24.2 (31 to 90 days), 20.7 (91 to 180 days), 15.7 (>180 days), and 7.9 (not previously hospitalized) per 100 patient-years. Compared with valsartan, absolute risk reductions with sacubitril/valsartan were more prominent in patients enrolled early after hospitalization: 6.4% (≤30 days), 4.6% (31 to 90 days), and 3.4% (91 to 180 days), whereas no risk reduction was observed in patients screened >180 days or who were never hospitalized (trend in absolute risk reduction: p interaction  = 0.050).
CONCLUSIONS


Recent hospitalization for HFpEF identifies patients at high risk for near-term clinical progression. In the PARAGON-HF trial, the relative and absolute benefits of sacubitril/valsartan compared with valsartan in HFpEF appear to be amplified when initiated in the high-risk window after hospitalization and warrant prospective validation. (PARAGON-HF; NCT01920711).",2020,"Over median 35 months follow-up, risk of total HF hospitalizations and cardiovascular death was inversely and non-linearly associated with timing from prior HF hospitalization (P<0.001).",['patients with HF and preserved ejection fraction (HFpEF'],"['valsartan', 'sacubitril/valsartan', 'Valsartan']","['absolute risk reductions', 'relative risk reduction', 'composite total HF hospitalizations and cardiovascular death, analyzed using a semiparametric proportional rates method, stratified by geographic region', 'risk reduction', 'rate of total primary events', 'risk of total HF hospitalizations and cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}]","[{'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205351', 'cui_str': 'Proportional (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.106937,"Over median 35 months follow-up, risk of total HF hospitalizations and cardiovascular death was inversely and non-linearly associated with timing from prior HF hospitalization (P<0.001).","[{'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: https://twitter.com/mvaduganathan.""}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: https://twitter.com/akshaydesaimd.""}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Division of Cardiology and Metabolism, Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies; German Centre for Cardiovascular Research (Deutsches Zentrum für Herz-Kreislauf-Forschung), Berlin, Germany; Charité Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Sergio V', 'Initials': 'SV', 'LastName': 'Perrone', 'Affiliation': 'Instituto Fleni, Buenos Aires, Argentina. Electronic address: https://twitter.com/svperrone.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Janssens', 'Affiliation': 'Department of Cardiology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Davor', 'Initials': 'D', 'LastName': 'Milicic', 'Affiliation': 'Department of Cardiovascular Diseases, University Hospital Center Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Juan L', 'Initials': 'JL', 'LastName': 'Arango', 'Affiliation': 'Guatemalan Heart Institute, Guatemala City, Guatemala.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, Texas; Imperial College, London, United Kingdom.'}, {'ForeName': 'Victor C', 'Initials': 'VC', 'LastName': 'Shi', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, New Jersey.'}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Lefkowitz', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, New Jersey.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: ssolomon@bwh.harvard.edu.""}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.11.003']
499,30924129,An exploration of the interrater agreement of visual analysis with and without context.,"Visual analysis is integral to the analysis of single-case experimental design (SCED) data. Previous studies have shown that many factors may influence the interrater agreement (IRA) of visual analysis. One factor that has received little direct attention is the impact of contextual information. In the current study, authors of recently published SCED studies were asked to make judgments regarding functional relations based on published datasets that met criteria for design quality. Respondents were randomly assigned to view graphs with or without contextual information and the degree of interrater agreement was compared. Results revealed that contextual information had no impact on IRA for decisions of a functional relation. IRA was high across both groups for 6 of the 7 datasets examined. Implications and recommendations based on these results are discussed.",2020,IRA was high across both groups for 6 of the 7 datasets examined.,[],[],['IRA'],[],[],[],,0.0562406,IRA was high across both groups for 6 of the 7 datasets examined.,"[{'ForeName': 'Andrea L B', 'Initials': 'ALB', 'LastName': 'Ford', 'Affiliation': 'Department of Educational Psychology, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Brenna N', 'Initials': 'BN', 'LastName': 'Rudolph', 'Affiliation': 'Department of Educational Psychology, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Pennington', 'Affiliation': 'Department of Educational Psychology, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Breanne J', 'Initials': 'BJ', 'LastName': 'Byiers', 'Affiliation': 'Department of Educational Psychology, University of Minnesota, Minneapolis, MN.'}]",Journal of applied behavior analysis,['10.1002/jaba.560']
500,31451306,Late clinical outcomes of unselected patients with diabetic mellitus and multi-vessel coronary artery disease.,"BACKGROUND


The Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multi-Vessel Disease (FREEDOM) clinical trial randomized only a proportion of screened patients with diabetes mellitus (DM) and multi-vessel disease (MVD).
METHODS AND RESULTS


We determined late rates of death, non-fatal myocardial infarction (MI) and stroke in all 430 patients with DM who had MVD identified on angiographic screening for the FREEDOM Trial, which recruited from June 2006 -March 2010 at Liverpool Hospital, Sydney, Australia. Mortality at 6 years [median] was 23% among 192 FREEDOM-eligible patients and 26% among 238 FREEDOM-ineligible patients, of whom 139 [58%] had prior. CABG (mortality 31%). Overall, 196 (45%) had percutaneous coronary intervention (PCI), 127 (30%) underwent coronary artery bypass grafting (CABG) (who were 4 years younger; p = 0.003), and 107 (25%) had neither procedure of whom 80 were considered unsuitable for revascularization. Mortality was 26% post-PCI 16%, post-CABG and 33% among those who did not undergo revascularization (p = 0.01). On multivariable analyses, factors associated with late mortality were older age, hypertension and not undergoing CABG (all p < 0.05). Factors associated with late MI were presented with an acute coronary syndrome, whereas patients that underwent treatment with either PCI or CABG had less late MI (all p < 0.05).
CONCLUSION


Among consecutive diabetic patients with MVD, at a median of 6-years CABG was associated with better survival and fewer non-fatal MI outcomes compared to PCI.",2019,"On multivariable analyses, factors associated with late mortality were older age, hypertension and not undergoing CABG (all p < 0.05).","['unselected patients with diabetic mellitus and multi-vessel coronary artery disease', '430 patients with DM who had MVD identified on angiographic screening for the FREEDOM Trial, which recruited from June 2006 -March 2010 at Liverpool Hospital, Sydney, Australia', 'Patients with Diabetes Mellitus', 'screened patients with diabetes mellitus (DM) and multi-vessel disease (MVD', 'consecutive diabetic patients with MVD']","['PCI or CABG', 'coronary artery bypass grafting (CABG']","['late MI', 'late rates of death, non-fatal myocardial infarction (MI) and stroke', 'Mortality', 'percutaneous coronary intervention (PCI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C1299432', 'cui_str': 'Multi vessel coronary artery disease'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]",430.0,0.0519275,"On multivariable analyses, factors associated with late mortality were older age, hypertension and not undergoing CABG (all p < 0.05).","[{'ForeName': 'Mohamed Eftal Bin Mohamed', 'Initials': 'MEBM', 'LastName': 'Ebrahim', 'Affiliation': 'Departments of Cardiology and Cardiothoracic Surgery, Liverpool Hospital, South Western Sydney Clinical School, the University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Dignan', 'Affiliation': 'Departments of Cardiology and Cardiothoracic Surgery, Liverpool Hospital, South Western Sydney Clinical School, the University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Femia', 'Affiliation': 'Departments of Cardiology and Cardiothoracic Surgery, Liverpool Hospital, South Western Sydney Clinical School, the University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Departments of Cardiology and Cardiothoracic Surgery, Liverpool Hospital, South Western Sydney Clinical School, the University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Gregory', 'Affiliation': 'University of Sydney, Australia.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Burgess', 'Affiliation': 'Departments of Cardiology and Cardiothoracic Surgery, Liverpool Hospital, South Western Sydney Clinical School, the University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Leia', 'Initials': 'L', 'LastName': 'Hee', 'Affiliation': 'Departments of Cardiology and Cardiothoracic Surgery, Liverpool Hospital, South Western Sydney Clinical School, the University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mussap', 'Affiliation': 'Departments of Cardiology and Cardiothoracic Surgery, Liverpool Hospital, South Western Sydney Clinical School, the University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Aty', 'Affiliation': 'Departments of Cardiology and Cardiothoracic Surgery, Liverpool Hospital, South Western Sydney Clinical School, the University of New South Wales, Sydney, NSW, Australia; Departments of Cardiothoracic Surgery, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Sidney', 'Initials': 'S', 'LastName': 'Lo', 'Affiliation': 'Departments of Cardiology and Cardiothoracic Surgery, Liverpool Hospital, South Western Sydney Clinical School, the University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Craig P', 'Initials': 'CP', 'LastName': 'Juergens', 'Affiliation': 'Departments of Cardiology and Cardiothoracic Surgery, Liverpool Hospital, South Western Sydney Clinical School, the University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'French', 'Affiliation': 'Departments of Cardiology and Cardiothoracic Surgery, Liverpool Hospital, South Western Sydney Clinical School, the University of New South Wales, Sydney, NSW, Australia. Electronic address: j.french@unsw.edu.au.'}]",International journal of cardiology,['10.1016/j.ijcard.2019.07.038']
501,31009695,"The EXACT protocol: A multi-centre, single-blind, randomised, parallel-group, controlled trial to determine whether early oxygen titration improves survival to hospital discharge in adult OHCA patients.","BACKGROUND


Experimental and observational research suggests hyperoxia following resuscitation from cardiac arrest is associated with neurological injury and worse clinical outcomes. This paper describes the rationale and design of the EXACT trial. EXACT aims to determine whether reducing oxygen in the acute phase of post-resuscitation care for out-of-hospital cardiac arrest (OHCA) improves survival.
METHODS


EXACT is a multi-centre, randomised (1:1), single-blind, parallel trial. Presumed cardiac OHCA cases who achieve a return of spontaneous circulation will be eligible if they are comatose, with an advanced airway and have an oxygen saturation (SpO 2 ) ≥95% on >10 L/min (or 100% oxygen). Paramedics will randomise 1416 eligible cases to receive oxygen therapy targeting an SpO 2  of 90-94% (intervention) or 98-100% (control). Study treatment will continue until admission to an intensive care unit or hospital ward. The primary outcome is survival to hospital discharge. Secondary outcomes include 12-month survival and quality of life.
RESULTS


The study has commenced in the Australian states of Victoria and South Australia, and has enrolled 167 eligible cases to date (80 intervention and 87 control). Further sites are due to commence in 2019, recruitment is expected to take three years.
CONCLUSION


This study will determine if early reduction of oxygen leads to improved outcomes in OHCA. Such a finding may potentially change clinical practice with implications on future OHCA survival outcomes.
TRIAL REGISTRATION NUMBER


NCT03138005.",2019,"The study has commenced in the Australian states of Victoria and South Australia, and has enrolled 167 eligible cases to date (80 intervention and 87 control).","['Australian states of Victoria and South Australia, and has enrolled 167 eligible cases to date (80 intervention and 87 control', 'adult OHCA patients']","['oxygen therapy', 'early oxygen titration']","['12-month survival and quality of life', 'survival to hospital discharge', 'survival']","[{'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0037715', 'cui_str': 'South Australia'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0034380'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",167.0,0.434839,"The study has commenced in the Australian states of Victoria and South Australia, and has enrolled 167 eligible cases to date (80 intervention and 87 control).","[{'ForeName': 'Janet E', 'Initials': 'JE', 'LastName': 'Bray', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Australia; Prehospital, Resuscitation and Emergency Care Research Unit, Curtin University, Australia; Alfred Hospital, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Australia; Ambulance Victoria, Australia; Department of Community Emergency Health and Paramedic Practice, Monash University, Australia.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Hein', 'Affiliation': 'SA Ambulance Service, Australia; Flinders University, Australia.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Finn', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Australia; Prehospital, Resuscitation and Emergency Care Research Unit, Curtin University, Australia; St John Ambulance Western Australia, Australia; Medical School, The University of Western Australia, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stephenson', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Australia; Ambulance Victoria, Australia; Department of Community Emergency Health and Paramedic Practice, Monash University, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Cameron', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Australia; Alfred Hospital, Australia.'}, {'ForeName': 'Dion', 'Initials': 'D', 'LastName': 'Stub', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Australia; Alfred Hospital, Australia; Ambulance Victoria, Australia.'}, {'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Australia; Warwick Medical School, University of Warwick, Coventry, United Kingdom.'}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Grantham', 'Affiliation': 'Prehospital, Resuscitation and Emergency Care Research Unit, Curtin University, Australia; SA Ambulance Service, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bailey', 'Affiliation': 'Prehospital, Resuscitation and Emergency Care Research Unit, Curtin University, Australia; St John Ambulance Western Australia, Australia.'}, {'ForeName': 'Deon', 'Initials': 'D', 'LastName': 'Brink', 'Affiliation': 'Prehospital, Resuscitation and Emergency Care Research Unit, Curtin University, Australia; St John Ambulance Western Australia, Australia.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Dodge', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bernard', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Australia; Alfred Hospital, Australia; Ambulance Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Resuscitation,['10.1016/j.resuscitation.2019.04.023']
502,31957468,Mechanistic Effects of Spironolactone on Cardiovascular and Renal Biomarkers in Heart Failure With Preserved Ejection Fraction: A TOPCAT Biorepository Study.,"BACKGROUND


Spironolactone has been demonstrated to reduce heart failure (HF) hospitalization in patients with HF with preserved ejection fraction in the Americas region of the TOPCAT trial (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist Trial). We assessed effects of 12 months of treatment with spironolactone on biomarkers reflecting myocardial stress, myocardial injury, renal function, and systemic inflammation.
METHODS


This TOPCAT biorepository substudy evaluated 247 patients (14% of the total 1767 patients in the Americas region) with symptomatic HF, ejection fraction ≥45%, and elevated natriuretic peptides or a prior HF hospitalization. Paired blood samples at baseline and after 12 months of treatment with spironolactone or placebo were available in 204 patients.
RESULTS


At baseline, the median (interquartile range) concentration of BNP (B-type natriuretic peptide) was 124 (69-197) ng/L, NT-proBNP (N-terminal-pro-B-type natriuretic peptide) 624 (307-1312) ng/L, hs-cTnI (high sensitivity cardiac troponin I) 6.3 (3.4-13.0) ng/L, hs-CRP (high sensitivity C-reactive protein) 2.8 (1.3-6.1) mg/L, uric acid 7.2 (5.8-8.7) mg/dL, and urine protein-creatinine ratio 0.11 (0.08-0.20) mg/mg. Compared with placebo-assigned participants at 12 months, those randomized to spironolactone experienced greater reductions from baseline in levels of NT-proBNP ( P =0.017) and BNP ( P =0.002); these differences persisted after adjustment for demographics, comorbidities, estimated glomerular filtration rate, and enrollment strata. No between-group differences in changes in hs-cTnI, CRP, uric acid, or urine protein-creatinine ratio were observed.
CONCLUSIONS


This TOPCAT biorepository substudy suggests potential effects on markers of cardiac wall stress or filling pressures during 12 months of treatment with spironolactone in patients with chronic HF with preserved ejection fraction.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT00094302.",2020,"No between-group differences in changes in hs-cTnI, CRP, uric acid, or urine protein-creatinine ratio were observed.
","['204 patients', 'patients with chronic HF with preserved ejection fraction', 'patients with HF with preserved ejection fraction in the Americas region of the TOPCAT trial (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist Trial', '247 patients (14% of the total 1767 patients in the Americas region) with symptomatic HF, ejection fraction ≥45%, and elevated natriuretic peptides or a prior HF hospitalization', 'Heart Failure']","['placebo', 'Preserved Ejection Fraction', 'proBNP', 'spironolactone', 'spironolactone or placebo', 'Spironolactone']","['levels of NT-proBNP', 'heart failure (HF) hospitalization', 'median (interquartile range) concentration of BNP (B-type natriuretic peptide', 'biomarkers reflecting myocardial stress, myocardial injury, renal function, and systemic inflammation', 'changes in hs-cTnI, CRP, uric acid, or urine protein-creatinine ratio', 'Cardiovascular and Renal Biomarkers', 'cardiac wall stress or filling pressures', 'BNP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0002007', 'cui_str': 'Aldosterone Antagonists'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C1305628', 'cui_str': 'Urine protein (substance)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",1767.0,0.506504,"No between-group differences in changes in hs-cTnI, CRP, uric acid, or urine protein-creatinine ratio were observed.
","[{'ForeName': 'Peder L', 'Initials': 'PL', 'LastName': 'Myhre', 'Affiliation': ""Cardiovascular Division (P.L.M., M.V., B.L.C., S.D.S., M.A.P., A.S.D.), Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Cardiovascular Division (P.L.M., M.V., B.L.C., S.D.S., M.A.P., A.S.D.), Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Meara"", 'Affiliation': 'Montreal Heart Institute, University of Montreal, Canada (E.O.M., S.d.D., J.L.R.).'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division (P.L.M., M.V., B.L.C., S.D.S., M.A.P., A.S.D.), Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'de Denus', 'Affiliation': 'Montreal Heart Institute, University of Montreal, Canada (E.O.M., S.d.D., J.L.R.).'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Jarolim', 'Affiliation': ""Department of Pathology (P.J.), Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'Department of Cardiovascular Medicine, University of Minnesota (I.S.A.).'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'University of Michigan School of Medicine, Ann Arbor (B.P.).'}, {'ForeName': 'Jean L', 'Initials': 'JL', 'LastName': 'Rouleau', 'Affiliation': 'Montreal Heart Institute, University of Montreal, Canada (E.O.M., S.d.D., J.L.R.).'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division (P.L.M., M.V., B.L.C., S.D.S., M.A.P., A.S.D.), Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': ""Cardiovascular Division (P.L.M., M.V., B.L.C., S.D.S., M.A.P., A.S.D.), Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Cardiovascular Division (P.L.M., M.V., B.L.C., S.D.S., M.A.P., A.S.D.), Brigham and Women's Hospital, Boston, MA.""}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.119.006638']
503,31937284,Teledentistry as a novel pathway to improve dental health in school children: a research protocol for a randomised controlled trial.,"BACKGROUND


Despite great improvement in child oral health, some children subgroups still suffer from higher levels of dental caries. Geographic and socioeconomic barriers and the lack of access to dental care services are among common reasons for poor oral health in children. Historically in Australia, oral health therapists or dental therapists have been responsible for providing dental care for school children through the School Dental Services (SDS). The current SDS has been unable to provide sustainable dental care to all school children due to a reduction in workforce participation and limited resources. We propose a paradigm shift in the current service through the introduction of user-friendly technology to provide a foundation for sustainable dental care for school children.
METHODS/DESIGN


We describe an ongoing parallel, two-armed, non-inferiority randomised controlled trial that compares routine and teledental pathway of dental care in children aged 4-15 years (n = 250). Participating schools in Western Australia will be randomly assigned to the control or teledental group, approximately three schools in each group with a maximum of 45 children in each school. All participants will first receive a standard dental examination to identify those who require urgent referrals and then their teeth will be photographed using a smartphone camera. At the baseline, children in the control group will receive screening results and advice on the pathway of dental care based on the visual dental screening while children in the teledental group will receive screening results based on the assessment of dental images. At 9 months follow-up, all participants will undergo a final visual dental screening. The primary outcomes include decay experience and proportion of children become caries active. The secondary outcomes include the diagnostic performance of photographic dental assessment and costs comparison of two pathways of dental care.
DISCUSSION


The current project seeks to take advantage of mobile technology to acquire dental images from a child's mouth at school settings and forwarding images electronically to an offsite dental practitioner to assess and prepare dental recommendations remotely. Such an approach will help to prioritise high-risk children and provide them with a quick treatment pathway and avoid unnecessary referrals or travel.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry, ACTRN12619001233112. Registered 06 September 2019.",2020,"Historically in Australia, oral health therapists or dental therapists have been responsible for providing dental care for school children through the School Dental Services (SDS).","['children', 'school children through the School Dental Services (SDS', 'children aged 4-15\u2009years (n\u2009=\u2009250', 'school children', 'Participating schools in Western Australia']",['routine and teledental pathway of dental care'],"['dental health', 'diagnostic performance of photographic dental assessment and costs comparison of two pathways of dental care', 'decay experience and proportion of children become caries active']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0260267', 'cui_str': 'School child (occupation)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0011331', 'cui_str': 'Dental Care'}]","[{'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C3853050', 'cui_str': 'Cost Comparison'}, {'cui': 'C0011331', 'cui_str': 'Dental Care'}, {'cui': 'C1265875', 'cui_str': 'Disintegration'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0429170', 'cui_str': 'Caries active (finding)'}]",45.0,0.106929,"Historically in Australia, oral health therapists or dental therapists have been responsible for providing dental care for school children through the School Dental Services (SDS).","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Estai', 'Affiliation': 'The Australian e-Health Research Centre, CSIRO, 147 Underwood Avenue, Floreat WA, Perth, 6014, Australia. abdalla177@gmail.com.'}, {'ForeName': 'Yogesan', 'Initials': 'Y', 'LastName': 'Kanagasingam', 'Affiliation': 'The Australian e-Health Research Centre, CSIRO, 147 Underwood Avenue, Floreat WA, Perth, 6014, Australia.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mehdizadeh', 'Affiliation': 'The Australian e-Health Research Centre, CSIRO, 147 Underwood Avenue, Floreat WA, Perth, 6014, Australia.'}, {'ForeName': 'Janardhan', 'Initials': 'J', 'LastName': 'Vignarajan', 'Affiliation': 'The Australian e-Health Research Centre, CSIRO, 147 Underwood Avenue, Floreat WA, Perth, 6014, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Norman', 'Affiliation': 'School of Public Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Boyen', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': 'School of Dentistry and Health Sciences, Charles Sturt University, Orange, Australia.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Spallek', 'Affiliation': 'Faculty of Medicine and Health, School of Dentistry, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Irving', 'Affiliation': 'Faculty of Medicine and Health, School of Dentistry, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Arora', 'Affiliation': 'Translational Health Research Institute, Western Sydney University, Campbelltown Campus, NSW, Australia.'}, {'ForeName': 'Estie', 'Initials': 'E', 'LastName': 'Kruger', 'Affiliation': 'School of Human Sciences, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Tennant', 'Affiliation': 'School of Human Sciences, University of Western Australia, Perth, Australia.'}]",BMC oral health,['10.1186/s12903-019-0992-1']
504,31952931,"Effectiveness of pretreatment with phosphoric acid, sodium hypochlorite and sulfinic acid sodium salt on root canal dentin resin bonding.","PURPOSE


The purpose of this study was to evaluate the effect of pretreatment using phosphoric acid, sodium hypochlorite and sulfinic acid sodium salt on the bonding of one-step self-etching adhesives to root canal dentin.
METHODS


Thirty-six single-rooted sound human premolars were randomly assigned into three groups before applying the one-step self-etching adhesive. These comprised a control group with no pretreatment, an NC group that received phosphoric acid and subsequent sodium hypochlorite gel pretreatments, and an NC+AC group that received an additional treatment with sulfinic acid sodium salt following the same pretreatment applied to the NC group. Microtensile bond strength measurements, bonding interface observations by scanning electron microscopy (SEM), elemental analyses by X-ray photoelectron spectroscopy (XPS) and degree of polymerization (DOP) analyses by Raman spectroscopy were subsequently performed.
RESULTS


The bond strength was significantly higher in the NC+AC group than in the other two groups (Control: P=000.1 and NC: P=0.004). SEM observations showed that resin tags were present in the dentinal tubules in the NC and NC+AC groups. Compared to the control group, the adhesive resin layer had a lower DOP in the NC group, while the DOP for the NC+AC group was higher than that of the NC specimens.
CONCLUSIONS


Bonding to root canal dentin was improved by applying sulfinic acid sodium salt in addition to treatment with phosphoric acid followed by sodium hypochlorite. The DOP of the adhesive resin was reduced by sodium hypochlorite and subsequently restored by applying sulfinic acid sodium salt.",2020,"Compared to the control group, the adhesive resin layer had a lower DOP in the NC group, while the DOP for the NC+AC group was higher than that of the NC specimens.
","['root canal dentin resin bonding', 'Thirty-six single-rooted sound human premolars']","['NC+AC', 'phosphoric acid, sodium hypochlorite and sulfinic acid sodium salt', 'scanning electron microscopy (SEM), elemental analyses by X-ray photoelectron spectroscopy (XPS', 'phosphoric acid, sodium hypochlorite and sulfinic acid sodium salt', 'sulfinic acid sodium salt', 'phosphoric acid and subsequent sodium hypochlorite gel pretreatments']","['DOP', 'bond strength', 'dentinal tubules']","[{'cui': 'C0086881', 'cui_str': 'Root Canal'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}]","[{'cui': 'C0031700', 'cui_str': 'Phosphoric acid'}, {'cui': 'C0037518', 'cui_str': 'Sodium Hypochlorite'}, {'cui': 'C0038741', 'cui_str': 'Sulfinic Acids'}, {'cui': 'C0351302', 'cui_str': 'Sodium salts (substance)'}, {'cui': 'C0026019', 'cui_str': 'Electron Microscopy'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2700282', 'cui_str': 'X-Ray Photoelectron Spectroscopy'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0227017', 'cui_str': 'Dentinal tubules (body structure)'}]",36.0,0.0103586,"Compared to the control group, the adhesive resin layer had a lower DOP in the NC group, while the DOP for the NC+AC group was higher than that of the NC specimens.
","[{'ForeName': 'Hayaki', 'Initials': 'H', 'LastName': 'Nakatani', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Mine', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, Japan. Electronic address: mine@dent.osaka-u.ac.jp.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Restorative Dentistry, Hokkaido University Graduate School of Dental Medicine, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Tajiri', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Hagino', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Yumitate', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Ban', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, Japan.'}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Miura', 'Affiliation': 'Division for Interdisciplinary Dentistry, Osaka University Dental Hospital, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Minamino', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Yatani', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, Japan.'}]",Journal of prosthodontic research,['10.1016/j.jpor.2019.08.003']
505,31953483,A noninferiority within-person study comparing the accuracy of transperineal to transrectal MRI-US fusion biopsy for prostate-cancer detection.,"BACKGROUND


Magnetic resonance imaging (MRI) and ultrasound (US) fusion prostate-biopsies can be performed in a transrectal (TR-fusion) or transperineal (TP-fusion) approach. Prospective comparative evidence is limited. In this study we compared the detection rate of clinically-significant prostate-cancer (csPCa) within an index lesion between TR and TP-fusion.
PATIENTS AND METHODS


This was a prospective, noninferiority, and within-person trial. Men scheduled for MRI-US-fusion with a discrete MRI PI-RRAD ≥ 3 lesion were included. A dominant index lesion was determined for each subject and sampled by TR and TP-fusion during the same session. The order of biopsies was randomized and equipment was reset to avoid chronological and incorporation bias. For each subject, the index lesion was sampled 4-6 times in each approach. All biopsies were performed using Navigo fusion software (UC-Care, Yokneam, Israel). csPCa was defined as: Grade Group ≥ 2 or cancer-core length ≥ 6 mm. We used a noninferiority margin of 10% and a one-sided alpha level of 5%.
RESULTS


Seventy-seven patients completed the protocol. Median age was 68.2 years (IQR:64.2-72.2), median PSA was 8.9 ng/ml (IQR:6.18-12.2). Ten patients (13%) were biopsy naive, others (87%) had a previous biopsy. csPCa was detected in 32 patients (42%). All of these cases were detected by TP-fusion, while only 20 (26%) by TR-fusion. Absolute difference for csPCa diagnosis was 15.6 (CI 90% 27.9-3.2%) in favor of TP-fusion (p = 0.029). TP-fusion was noninferior to TR-fusion. The lower boundary of the 90% confidence-interval between TP-fusion and TR-fusion was greater than zero, therefore TP-fusion was also found to be superior. Exploratory subgroup analyses showed TP-fusion was consistently associated with higher detection rates of csPCa compared with TR-fusion in patient and index-lesion derived subgroups (size, location, PI-RADS, PSA, and biopsy history).
CONCLUSIONS


In this study, TP-fusion biopsies were found to be noninferior and superior to TR-fusion biopsies in detecting csPCa within MRI-visible index lesion. Centers experienced in both TP and TR-fusion should consider these results when choosing biopsy method.",2020,"Exploratory subgroup analyses showed TP-fusion was consistently associated with higher detection rates of csPCa compared with TR-fusion in patient and index-lesion derived subgroups (size, location, PI-RADS, PSA, and biopsy history).
","['Ten patients (13%) were biopsy naive, others (87%) had a previous biopsy', 'Men scheduled for MRI-US-fusion with a discrete MRI PI-RRAD\u2009≥\u20093 lesion were included', 'Seventy-seven patients completed the protocol']","['Magnetic resonance imaging (MRI) and ultrasound (US) fusion prostate-biopsies', 'transperineal to transrectal MRI-US fusion biopsy']","['csPCa', 'csPCa diagnosis', 'TP-fusion', 'median PSA', 'detection rate of clinically-significant prostate-cancer (csPCa']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205500', 'cui_str': 'Perineal approach (qualifier value)'}, {'cui': 'C0205518', 'cui_str': 'Transrectal approach (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",77.0,0.0226582,"Exploratory subgroup analyses showed TP-fusion was consistently associated with higher detection rates of csPCa compared with TR-fusion in patient and index-lesion derived subgroups (size, location, PI-RADS, PSA, and biopsy history).
","[{'ForeName': 'Yaara', 'Initials': 'Y', 'LastName': 'Ber', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petah-Tikva, Israel.'}, {'ForeName': 'Niv', 'Initials': 'N', 'LastName': 'Segal', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petah-Tikva, Israel.'}, {'ForeName': 'Shlomit', 'Initials': 'S', 'LastName': 'Tamir', 'Affiliation': 'Department of Imaging, Rabin Medical Center, Petah-Tikva, Israel.'}, {'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Benjaminov', 'Affiliation': 'Division of Imaging, Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Yakimov', 'Affiliation': 'Department of Pathology, Rabin Medical Center, Petah-Tikva, Israel.'}, {'ForeName': 'Sivan', 'Initials': 'S', 'LastName': 'Sela', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petah-Tikva, Israel.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Halstauch', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petah-Tikva, Israel.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Baniel', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petah-Tikva, Israel.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kedar', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petah-Tikva, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Margel', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petah-Tikva, Israel. sdmargel@gmail.com.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-020-0205-7']
506,31939556,Physical and functional aspects of persons with multiple sclerosis practicing Tai-Geiko: randomized trial.,"OBJECTIVES


This study aimed to verify the influence of Tai-Geiko on the physical and functional aspects of people with multiple sclerosis (MS).
METHODS


This was a parallel-group, randomized trial with two arms. People with MS were allocated to an experimental group (EG) (n=10) and control group (CG) (n=09). The participants received multidisciplinary care supervised by a physiotherapist in the Tai-Geiko exercise. Participants underwent the assessments after the intervention. The Expanded Disability Status Scale (EDSS-maximum score of 6.0), strength test (kgf) using a dynamometer, Timed Up and Go mobility test (TUG), and stabilometric balance test (Platform EMG system®) were evaluated. Demographic data were recorded, including age, sex, comorbidities, lifestyle and classification of MS. Clinical Trials (ReBeC): RBR-4sty47.
RESULTS


The EG group improved in 12 variables, and the CG improved in 3 variables. The following values were obtained for pre/postintervention, respectively: EG: lumbar force (38/52 kgf), TUG (11/9 s), locomotion velocity (519/393 ms); double task two (53/39 s); platform stabilometric trajectory: traversed get up (39/26 s) and sit (45/29 s); anteroposterior (AP) amplitude rise (11/8 cm) and sit (12.40/9.94 cm) and anteroposterior frequency rise (1.00/1.56 Hz) and sit (0.8/1.25 Hz) (p<0.05); CG: right-hand grip force (26/29 kgf); TUG (9.8 /8.7 s) and AP (11.84 /9.53 cm) stabilometric amplitude at the sitting moment (p<0.05), (3.2/5.99 Hz, p=0.01) and sit (3.47/5.01 Hz, p=0.04).
CONCLUSION


Tai-Geiko practice can be suggested as complementary exercise in the rehabilitation of persons with MS.",2020,"The Expanded Disability Status Scale (EDSS-maximum score of 6.0), strength test (kgf) using a dynamometer, Timed Up and Go mobility test (TUG), and stabilometric balance test (Platform EMG system®) were evaluated.","['persons with multiple sclerosis practicing Tai-Geiko', 'persons with MS', 'People with MS', 'people with multiple sclerosis (MS']","['Tai-Geiko', 'multidisciplinary care supervised by a physiotherapist in the Tai-Geiko exercise']","['anteroposterior frequency rise', 'Expanded Disability Status Scale (EDSS-maximum score of 6.0), strength test (kgf) using a dynamometer, Timed Up and Go mobility test (TUG), and stabilometric balance test (Platform EMG system®', 'locomotion velocity (519/393 ms); double task two (53/39 s); platform stabilometric trajectory: traversed get up (39/26 s) and sit (45/29 s); anteroposterior (AP) amplitude rise']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}]","[{'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}, {'cui': 'C2919666', 'cui_str': 'Timed up and go mobility test (assessment scale)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0023946', 'cui_str': 'Locomotor Activity'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}]",,0.0373107,"The Expanded Disability Status Scale (EDSS-maximum score of 6.0), strength test (kgf) using a dynamometer, Timed Up and Go mobility test (TUG), and stabilometric balance test (Platform EMG system®) were evaluated.","[{'ForeName': 'Viviane Regina Leite Moreno', 'Initials': 'VRLM', 'LastName': 'Ultramari', 'Affiliation': 'Nucleo de Estudo em Aptidao Fisica, Informatica, Metabolismo, Esporte e Saude (NAFIMES), Universidade Federal do Mato Grosso, MT, BR.'}, {'ForeName': 'Adriano Percival Calderaro', 'Initials': 'APC', 'LastName': 'Calvo', 'Affiliation': 'Programa de Pos Graduacao em Desempenho Humano Operacional (PPGDHO), Universidade da Forca Aerea (UNIFA), Rio de Janeiro, RJ, BR.'}, {'ForeName': 'Rosilene Andrade Silva', 'Initials': 'RAS', 'LastName': 'Rodrigues', 'Affiliation': 'Nucleo de Estudo em Aptidao Fisica, Informatica, Metabolismo, Esporte e Saude (NAFIMES), Universidade Federal do Mato Grosso, MT, BR.'}, {'ForeName': 'Waléria Christiane Rezende', 'Initials': 'WCR', 'LastName': 'Fett', 'Affiliation': 'Nucleo de Estudo em Aptidao Fisica, Informatica, Metabolismo, Esporte e Saude (NAFIMES), Universidade Federal do Mato Grosso, MT, BR.'}, {'ForeName': 'Jose Urias de', 'Initials': 'JU', 'LastName': 'Moraes Neto', 'Affiliation': 'Nucleo de Estudo em Aptidao Fisica, Informatica, Metabolismo, Esporte e Saude (NAFIMES), Universidade Federal do Mato Grosso, MT, BR.'}, {'ForeName': 'Almir de França', 'Initials': 'AF', 'LastName': 'Ferraz', 'Affiliation': 'Grupo de Estudos em Actividade Fisica e Promocao da Saude, Departamento de Graduacao em Educacao Fisica, Universidade Sao Judas Tadeu (USJT), Sao Paulo, SP, BR.'}, {'ForeName': 'Michelle Jalousie', 'Initials': 'MJ', 'LastName': 'Kommers', 'Affiliation': 'Nucleo de Estudo em Aptidao Fisica, Informatica, Metabolismo, Esporte e Saude (NAFIMES), Universidade Federal do Mato Grosso, MT, BR.'}, {'ForeName': 'Heloise Helena Siqueira', 'Initials': 'HHS', 'LastName': 'Borges', 'Affiliation': 'Nucleo de Estudo em Aptidao Fisica, Informatica, Metabolismo, Esporte e Saude (NAFIMES), Universidade Federal do Mato Grosso, MT, BR.'}, {'ForeName': 'Michell Vetoraci', 'Initials': 'MV', 'LastName': 'Viana', 'Affiliation': 'Grupo de Estudos em Actividade Fisica e Promocao da Saude, Departamento de Graduacao em Educacao Fisica, Universidade Sao Judas Tadeu (USJT), Sao Paulo, SP, BR.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Cattafesta', 'Affiliation': 'Programa de Pos Graduacao em Saude Coletiva (PPGSC), Centro de Ciencias da Saude, Universidade Federal do Espirito Santo (UFES), Vitoria, ES, BR.'}, {'ForeName': 'Luciane Bresciani', 'Initials': 'LB', 'LastName': 'Salaroli', 'Affiliation': 'Programa de Pos Graduacao em Saude Coletiva (PPGSC), Centro de Ciencias da Saude, Universidade Federal do Espirito Santo (UFES), Vitoria, ES, BR.'}, {'ForeName': 'Carlos Alexandre', 'Initials': 'CA', 'LastName': 'Fett', 'Affiliation': 'Nucleo de Estudo em Aptidao Fisica, Informatica, Metabolismo, Esporte e Saude (NAFIMES), Universidade Federal do Mato Grosso, MT, BR.'}]","Clinics (Sao Paulo, Brazil)",['10.6061/clinics/2020/e1272']
507,31576651,Video game distraction and anesthesia mask practice reduces children's preoperative anxiety: A randomized clinical trial.,"PURPOSE


The study aims to evaluate the effectiveness of combined video game distraction and anesthesia mask exposure and shaping intervention as compared to conventional preoperative preparation on the preoperative anxiety, anesthesia induction compliance and emergence delirium of children undergoing day-case surgery.
DESIGN AND METHODS


The CONSORT guidelines were followed in the current study; a randomized clinical trial, two groups, pre posttest, between subjects design with 1:1 allocation ratio was employed. Children (5-11 years of age; N = 128) admitted for day case surgery were invited to participate in the study. Sixty-four children were assigned to the intervention group receiving combined videogame distraction and anesthesia mask exposure and shaping intervention, and 64 children were assigned to the control group.
RESULTS


The results showed that children in the intervention group reported statistically significant lower anxiety scores than the children in the control group at three preoperative points of time: postintervention t = 4.48, p < .001, at the time of transfer to the operation room t = 10.18; p < .001 and during anesthesia induction t = 7.76; p < .001. In addition, compared with the children in the control group, fewer children in the intervention group demonstrated poor anesthesia induction compliance χ 2   = 3.91; p = .04. The results, however, did not reveal statistically significant differences in children's emergence delirium scores.
PRACTICE IMPLICATION


Combined video game distraction and anesthesia mask exposure and shaping are simple, safe, and time-effective intervention that the nurses can implement at the day of surgery to mitigate children anxiety and to enhance their anesthesia induction compliance.",2020,"The results showed that children in the intervention group reported statistically significant lower anxiety scores than the children in the control group at three preoperative points of time: postintervention t = 4.48, p < .001, at the time of transfer to the operation room t = 10.18; p < .001 and during anesthesia induction t = 7.76; p < .001.","['children undergoing day-case surgery', ""children's preoperative anxiety"", 'Sixty-four children', 'Children (5-11 years of age; N\u2009=\u2009128) admitted for day case surgery were invited to participate in the study']","['combined video game distraction and anesthesia mask exposure and shaping intervention', 'Video game distraction and anesthesia mask practice', 'intervention group receiving combined videogame distraction and anesthesia mask exposure and shaping intervention']","['anxiety scores', ""children's emergence delirium scores"", 'poor anesthesia induction compliance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C1369038', 'cui_str': 'Distraction (procedure)'}, {'cui': 'C0181751', 'cui_str': 'Anesthesia mask (physical object)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0920253', 'cui_str': 'Postanesthetic Excitement'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia (procedure)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",64.0,0.0345006,"The results showed that children in the intervention group reported statistically significant lower anxiety scores than the children in the control group at three preoperative points of time: postintervention t = 4.48, p < .001, at the time of transfer to the operation room t = 10.18; p < .001 and during anesthesia induction t = 7.76; p < .001.","[{'ForeName': ""Doa'a Abdullah"", 'Initials': 'DA', 'LastName': 'Dwairej', 'Affiliation': 'Department of clinical nursing, School of Nursing, The University of Jordan, Amman, Jordan.'}, {'ForeName': 'Hala Mahmoud', 'Initials': 'HM', 'LastName': 'Obeidat', 'Affiliation': 'Department of maternal and child health nursing, Faculty of Nursing, Mutah University, Amman, Jordan.'}, {'ForeName': 'Abdelkarim Saleh', 'Initials': 'AS', 'LastName': 'Aloweidi', 'Affiliation': 'Department of anesthesia and intensive care, School of Medicine, The University of Jordan, Amman, Jordan.'}]",Journal for specialists in pediatric nursing : JSPN,['10.1111/jspn.12272']
508,31939337,A Solution-Focused Coaching Intervention with Children and Youth with Cerebral Palsy to Achieve Participation-Oriented Goals.,"Background:  The ultimate goal of therapeutic intervention is meaningful participation in one's world. For people with Cerebral Palsy (CP), limitations can often become a focus of care. Aim:  Our purpose was to investigate the impact of a Solution-Focused Coaching intervention designed for pediatric rehabilitation (SFC-peds) on the attainment of participation goals for children/youth with CP. Method:  Twelve participants participated in a repeated measures quantitative study and in qualitative interviews. Children and youth (ages 6-19) and their families participated in three to five coaching sessions, including an initial baseline goal setting session, with one additional follow-up session as well as the qualitative interviews. The Canadian Occupational Performance Measure and Goal Attainment Scaling were incorporated into initial coaching sessions and then re-administered by a blind assessor within one month post-intervention. Qualitative interviews were conducted at this time. Results:  Statistically significant improvements were found in goal performance, satisfaction, and attainment. Interview data included consideration of both the content of the intervention ( what  the practitioner is doing) and the unique SFC-peds process ( how  the client feels about the intervention). Conclusions:  SFC-peds may present an effective approach for working with children/youth with CP to achieve self-selected participation-oriented goals in a relatively short time-period.",2020,"Statistically significant improvements were found in goal performance, satisfaction, and attainment.","['Children and Youth with Cerebral Palsy', 'children/youth with CP', 'Twelve participants participated in a repeated measures quantitative study and in qualitative interviews', 'Children and youth (ages 6-19) and their families participated', 'people with Cerebral Palsy (CP']","['A Solution-Focused Coaching Intervention', 'Solution-Focused Coaching intervention designed for pediatric rehabilitation (SFC-peds']","['goal performance, satisfaction, and attainment', 'Canadian Occupational Performance Measure and Goal Attainment Scaling']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C4521536', 'cui_str': 'United States Military enlisted E7 (qualifier value)'}]","[{'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure (assessment scale)'}]",12.0,0.0152257,"Statistically significant improvements were found in goal performance, satisfaction, and attainment.","[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Schwellnus', 'Affiliation': 'Holland Bloorview Kids Rehabilitation Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'King', 'Affiliation': 'Bloorview Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Baldwin', 'Affiliation': 'Private practice, London, Ontario, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Keenan', 'Affiliation': 'Holland Bloorview Kids Rehabilitation Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Laura R', 'Initials': 'LR', 'LastName': 'Hartman', 'Affiliation': 'Bloorview Research Institute, Toronto, Ontario, Canada.'}]",Physical & occupational therapy in pediatrics,['10.1080/01942638.2020.1711841']
509,31837240,Model-based analysis of therapeutic efficacy of blonanserin and risperidone in schizophrenia patients and effects on prolactin: A randomized double-blind study.,"This study examined randomized controlled trial data for blonanserin and risperidone in Chinese schizophrenia patients (N = 264). Data related to historical changes in the Positive and Negative Syndrome Scale (PANSS) were used to successfully construct a longitudinal E max  model. Results: (a) The efficacy of the two drugs was similar after week 8, showing a small difference in PANSS reduction. (b) Using the model, we predicted that each 5-point increase in the baseline FPOS (positive score in PANSS five-factor subscales) leads to a decrease in the PANSS total scores at week 8 for 2 points in patients administered blonanserin. (c) The effect of blonanserin on prolactin (PRL) elevation was less. The model was used to predict that prolactin elevations in patients administered risperidone were 2.41-fold of those in patients administered blonanserin. (d) Model quantitation showed that gender is a risk factor for prolactin elevation. Prolactin elevations in female patients were 2.95-fold of the value in male patients administered the same drug. The model demonstrated Blonanserin has similar antischizophrenic efficacy and less serum prolactin rising compared to risperidone in Chinese patients.",2020,The model demonstrated Blonanserin has similar antischizophrenic efficacy and less serum prolactin rising compared to risperidone in Chinese patients.,"['Chinese patients', 'schizophrenia patients', 'female patients', 'Chinese schizophrenia patients (N = 264']","['blonanserin', 'blonanserin and risperidone', 'Blonanserin', 'risperidone']","['PANSS total scores', 'serum prolactin rising', 'Prolactin elevations', 'prolactin elevations', 'antischizophrenic efficacy', 'baseline FPOS', 'prolactin', 'prolactin (PRL) elevation']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0287983', 'cui_str': 'blonanserin'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1277972', 'cui_str': 'Serum prolactin measurement'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",,0.0346201,The model demonstrated Blonanserin has similar antischizophrenic efficacy and less serum prolactin rising compared to risperidone in Chinese patients.,"[{'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Lei', 'Affiliation': 'Sumitomo Pharmaceuticals(Suzhou) Co., Ltd., Shanghai, China.'}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yifeng', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Huafang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}]",Human psychopharmacology,['10.1002/hup.2717']
510,31969301,Effectiveness of Simvastatin 1% oral gel and mouthwash used as an adjunct treatment of scaling and root planning in the treatment of periodontal diseases.,"Simvastatin is an anti-hyperlipidemic drug which reduces the cholesterol synthesis and also has anti-inflammatory, immunomodulatory and anti-microbial action against the bacteria. This develops the interest of periodontologist to use it in combination with conventional treatment to treat periodontal diseases. The objective of the study was to develop the gel and mouthwash of simvastatin and use it locally to treat gingivitis and periodontitis as an adjunct to scaling and root planning. The patients were randomly allocated into three groups that were standard treatment group, gel treatment group and mouthwash treatment group. Results indicated that simvastatin gel and mouthwash in 1% preparation showed favorable results by significantly reducing periodontal parameters and inflammatory biomarkers (p<0.001) as compared to standard treatment. Thus, we strongly suggest the use of simvastatin by local drug delivery system as an adjunct treatment of scaling and root planning.",2019,Results indicated that simvastatin gel and mouthwash in 1% preparation showed favorable results by significantly reducing periodontal parameters and inflammatory biomarkers (p<0.001) as compared to standard treatment.,['periodontal diseases'],"['gel treatment group and mouthwash treatment group', 'simvastatin gel', 'simvastatin', 'Simvastatin']",['periodontal parameters and inflammatory biomarkers'],"[{'cui': 'C0031090', 'cui_str': 'Parodontosis'}]","[{'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.0125566,Results indicated that simvastatin gel and mouthwash in 1% preparation showed favorable results by significantly reducing periodontal parameters and inflammatory biomarkers (p<0.001) as compared to standard treatment.,"[{'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Hasan', 'Affiliation': 'Department of Pharmacology, Fatima Jinnah Dental College, Karachi, Pakistan.'}, {'ForeName': 'Rahila', 'Initials': 'R', 'LastName': 'Ikram', 'Affiliation': 'Department of Pharmacology, Faculty of Pharmacy & Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan.'}, {'ForeName': 'Shabana Usman', 'Initials': 'SU', 'LastName': 'Simjee', 'Affiliation': 'HEJ Research Institute of Chemistry, International Centre of Chemical and Biological Sciences, University of Karachi, Pakistan.'}, {'ForeName': 'Kanwal', 'Initials': 'K', 'LastName': 'Iftakhar', 'Affiliation': 'HEJ Research Institute of Chemistry, International Centre of Chemical and Biological Sciences, University of Karachi, Pakistan.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Asadullah', 'Affiliation': 'Crown Dental Clinic, Karachi, Pakistan.'}]",Pakistan journal of pharmaceutical sciences,[]
511,31903773,Pragmatic randomised controlled trial of a personalised intervention for carers of people requiring home oxygen therapy.,"We used a pragmatic randomised controlled trial to evaluate a behavioural change strategy targeting carers of chronically hypoxaemic patients using long-term home oxygen therapy. Intervention group carers participated in personalised educational sessions focusing on motivating carers to take actions to assist patients. All patients received usual care. Effectiveness was measured through a composite event of patient survival to hospitalisation, residential care admission or death to 12 months. Secondary outcomes at baseline, 3, 6 and 12 months included carer and patient emotional and physical well-being. No difference between intervention ( n  = 100) and control ( n  = 97) patients was found for the composite outcome (hazard ratio (HR) 1.22, 95% confidence interval (CI) = 0.89, 1.68;  p  = 0.22). Improved fatigue, mastery, vitality and general health occurred in intervention group patients (all  p  values < 0.05). No benefits were seen in carer outcomes. Mortality was significantly higher in intervention patients (HR = 2.01, 95% CI = 1.00, 4.14;  p  = 0.05; adjusted for Australia-modified Karnofsky Performance Status), with a significant diagnosis-intervention interaction ( p  = 0.028) showing higher mortality in patients with COPD (HR 4.26; 95% CI = 1.60, 11.35) but not those with interstitial lung disease (HR 0.83; 95% CI = 0.28, 2.46). No difference was detected in the primary outcome, but patient mortality was higher when carers had received the intervention, especially in the most disabled patients. Trials examining behavioural change interventions in severe disease should stratify for functionality, and both risks and benefits should be independently monitored.  Trial registration:  Australian New Zealand Clinical Trials Registry (ACTRN12607000177459).",2020,"Mortality was significantly higher in intervention patients (HR = 2.01, 95% CI = 1.00, 4.14;  ","['chronically hypoxaemic patients using long-term home oxygen therapy', 'carers of people requiring home oxygen therapy']","['personalised educational sessions', 'personalised intervention', 'usual care']","['composite event of patient survival to hospitalisation, residential care admission or death to 12 months', 'Improved fatigue, mastery, vitality and general health', 'carer and patient emotional and physical well-being', 'Mortality', 'interstitial lung disease', 'patient mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1960973', 'cui_str': 'Home oxygen therapy (procedure)'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}]",[],"[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1869044', 'cui_str': 'Interstitial lung disease (SMQ)'}]",,0.274764,"Mortality was significantly higher in intervention patients (HR = 2.01, 95% CI = 1.00, 4.14;  ","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Frith', 'Affiliation': 'College of Medicine & Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Sladek', 'Affiliation': 'College of Medicine & Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Woodman', 'Affiliation': 'Flinders Centre for Epidemiology and Biostatistics, College of Medicine & Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Effing', 'Affiliation': 'College of Medicine & Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Bradley', 'Affiliation': 'College of Nursing & Health Sciences, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'van Asten', 'Affiliation': 'Department of Internal Medicine, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Jones', 'Affiliation': 'Department for Health and Well-being, SA Health, Adelaide, Australia.'}, {'ForeName': 'Khin', 'Initials': 'K', 'LastName': 'Hnin', 'Affiliation': 'Adelaide Sleep Health, Southern Adelaide Local Health Network, Adelaide, Australia.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Luszcz', 'Affiliation': 'Department of Psychology, College of Education, Psychology & Social Work, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Cafarella', 'Affiliation': 'College of Medicine & Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Eckermann', 'Affiliation': 'Australian Health Services Research Institute, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Rowett', 'Affiliation': 'Drug and Therapeutics Information Service, Southern Adelaide Local Health Network, Adelaide, Australia.'}, {'ForeName': 'Paddy A', 'Initials': 'PA', 'LastName': 'Phillips', 'Affiliation': 'College of Medicine & Public Health, Flinders University, Adelaide, Australia.'}]",Chronic respiratory disease,['10.1177/1479973119897277']
512,31931678,Simple-categorization dominance and evaluation of the crossed-categorization target: comparison of different perspectives.,"The current study analyzed the effect of simple-categorization dominance on the evaluation of crossed-categorization target from the perspective of observer (other) and actor (self). With a focus on the young-poor target, in Study 1 and Study 2, participants were assigned to observer or actor perspective and were randomly assigned to one of three experimental groups: age simple-categorization dominant, wealth simple-categorization dominant, and a control group. Study 1 demonstrated that in the observer perspective group, the evaluation of the competence of the young-poor target in the wealth simple-categorization dominant group was higher than that in the age simple-categorization dominant group. In the actor perspective group, the self-evaluation of the competence in the wealth simple-categorization dominant group was lower than in the age simple-categorization dominant group. Study 2 showed that simple-categorization dominance was not associated with the evaluation of the young-poor target. These results have implications for understanding the evaluation of the crossed-categorization target.",2020,"In the actor perspective group, the self-evaluation of the competence in the wealth simple-categorization dominant group was lower than in the age simple-categorization dominant group.",[],"['age simple-categorization dominant, wealth simple-categorization dominant, and a control group']",[],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.0144436,"In the actor perspective group, the self-evaluation of the competence in the wealth simple-categorization dominant group was lower than in the age simple-categorization dominant group.","[{'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'China University of Geosciences.'}, {'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Ruan', 'Affiliation': 'China University of Geosciences.'}]",The Journal of general psychology,['10.1080/00221309.2019.1711355']
513,31933395,"Efficacy of a Community Health Worker-Based Intervention in Improving Dietary Habits Among Community-Dwelling Older People: A Controlled, Crossover Trial in Japan.","Background.  Community health workers (CHWs), often called ""health promotion volunteers"" in Japan, are individuals who act as a natural helping resource in the community.  Aim.  This study tested the efficacy of a CHW-based intervention to improve dietary habits among community-dwelling older people in Japan, using a controlled, crossover design.  Method.  Seventy-eight people aged 65 to 74 years with poor dietary variety living in four administrative districts in Hikone City (Shiga Prefecture, Japan) were nonrandomly allocated to an immediate-intervened group (IIG;  n  = 41) or a delayed-intervened group (DIG;  n  = 37). Participants joined a biweekly, four-session program (120 minutes/session), comprising ""CHW drama-style lectures,"" ""group discussion among participants and CHWs,"" ""tasting of dishes,"" and ""take-home practical activities."" For the initial 2-month period, the IIG received the intervention and the DIG did not. The groups were crossed over for the subsequent 2-month period. The primary outcome measure was participants' dietary variety score (score range: 0-10).  Results.  The dietary variety score in the IIG significantly increased in the initial 2-month period compared with the DIG (effect size 1.60 points; 95% confidence interval: 0.75, 2.45). The intervention had a similar effect in the DIG in the subsequent 2-month period. Moreover, an analysis within the IIG showed that the intervention effects persisted for at least 2 months after the intervention.  Conclusions.  The CHW-based intervention improved dietary habits among older people. Our findings provide evidence that a CHW-based natural helping approach is a possible solution to promote healthy aging in the community.",2020,"This study tested the efficacy of a CHW-based intervention to improve dietary habits among community-dwelling older people in Japan, using a controlled, crossover design.  ","['community-dwelling older people in Japan', 'older people', 'Community health workers (CHWs), often called ""health promotion volunteers"" in Japan', 'Japan', 'Community-Dwelling Older People', 'Seventy-eight people aged 65 to 74 years with poor dietary variety living in four administrative districts in Hikone City (Shiga Prefecture, Japan']","['CHW drama-style lectures,"" ""group discussion among participants and CHWs,"" ""tasting of dishes,"" and ""take-home practical activities', 'Community Health Worker-Based Intervention', 'CHW-based intervention', 'immediate-intervened group (IIG;  n  = 41) or a delayed-intervened group']","['dietary variety score', 'Dietary Habits', 'dietary habits', ""participants' dietary variety score (score range: 0-10""]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0013109', 'cui_str': 'Drama'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0020498', 'cui_str': 'Vertebral Ankylosing Hyperostosis'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C3542016', 'cui_str': 'Range'}]",78.0,0.04441,"This study tested the efficacy of a CHW-based intervention to improve dietary habits among community-dwelling older people in Japan, using a controlled, crossover design.  ","[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Murayama', 'Affiliation': 'The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Taguchi', 'Affiliation': 'Tohoku University, Miyagi, Japan.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Spencer', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Takuhiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Tohoku University, Miyagi, Japan.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198119891975']
514,31928229,Prospective  CYP2C19  Genotyping to Guide Antiplatelet Therapy Following Percutaneous Coronary Intervention: A Pragmatic Randomized Clinical Trial.,"BACKGROUND


CYP2C19  loss-of-function alleles impair clopidogrel effectiveness after percutaneous coronary intervention, but the clinical impact of implementing  CYP2C19  genotyping in a real-world setting is unknown. The purpose of the study was to determine whether returning  CYP2C19  genotype results along with genotype-guided pharmacotherapy recommendations using a rapid turnaround test would change antiplatelet prescribing following percutaneous coronary intervention.The primary outcome was the rate of prasugrel or ticagrelor prescribing in each arm. Secondary outcomes included agreement to the genotype-guided recommendations.
METHODS


At the time of percutaneous coronary intervention, participants were randomly assigned to prospective rapid point-of-care genotyping of  CYP2C19  major alleles (*2, *3, *17) via salivary swab (genotyped group) or no genotyping (usual care) to guide antiplatelet drug selection. Interventional cardiologists at 2 cardiac catheterization laboratories within the same health system were provided genotype information along with genotype-guided pharmacotherapy recommendations.
RESULTS


A total of 504 participants were randomized, 249 to the genotyped and 255 to the usual care group. The participants were primarily men (73%); age, 63±10 years; and 50% had acute coronary syndromes. In the genotyped group, 28% were carriers of loss-of-function alleles (*2, *3). The use of prasugrel or ticagrelor was significantly higher in the genotyped group compared with the usual care group (30% versus 21%; odds ratio, 1.60 [95% CI, 1.07-2.42];  P =0.03). Within the genotyped group, 53% of loss-of-function allele carriers were started on prasugrel/ticagrelor, while 47% were started on clopidogrel.
CONCLUSIONS


In a randomized controlled trial of clinical  CYP2C19  genotyping implementation, pharmacogenetic test results significantly influenced antiplatelet drug prescribing; however, almost half of  CYP2C19  loss-of-function carriers continued to receive clopidogrel. Interventional cardiologists consider both clinical and genetic factors when selecting antiplatelet therapy following percutaneous coronary intervention.
CLINICAL TRIAL REGISTRATION


URL: http://www.clinicaltrials.gov. Unique Identifier: NCT02508116.",2020,"The use of prasugrel or ticagrelor was significantly higher in the genotyped group compared to the usual care group (30% vs 21%, OR 1.60, 95% CI 1.07 to 2.42, p=0.03).","['504 participants were randomized, 249 to the genotyped and 255 to the usual care group', 'participants were primarily male (73', 'age 63{plus minus}10 years, and 50% had acute coronary syndromes']","['clopidogrel', 'salivary swab (genotyped group) or no genotyping (usual care) to guide antiplatelet drug selection', 'prasugrel or ticagrelor', 'percutaneous coronary intervention (PCI', 'prasugrel/ticagrelor']","['loss-of-function (LOF) alleles', 'agreement to the genotype guided recommendations']","[{'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C1261188', 'cui_str': 'Swab (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0085826', 'cui_str': 'Antiplatelet Agents'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0002085', 'cui_str': 'Allelomorphs'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]",504.0,0.119029,"The use of prasugrel or ticagrelor was significantly higher in the genotyped group compared to the usual care group (30% vs 21%, OR 1.60, 95% CI 1.07 to 2.42, p=0.03).","[{'ForeName': 'Sony', 'Initials': 'S', 'LastName': 'Tuteja', 'Affiliation': 'Department of Medicine, Division of Translational Medicine and Human Genetics (S.T., K. Monono, D.J.R.), University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Glick', 'Affiliation': 'Department of Biostatistics and Epidemiology (H.G.), University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Matthai', 'Affiliation': 'Cardiovascular Medicine Division (W.M., A.N., C.C., K. Maslowski, G.C., T.K., S.A., J.H., R.L.W., H.C.H., D.M.K., J.G.), University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Irving', 'Initials': 'I', 'LastName': 'Nachamkin', 'Affiliation': 'Department of Pathology and Laboratory Medicine (I.N.), University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Ashwin', 'Initials': 'A', 'LastName': 'Nathan', 'Affiliation': 'Cardiovascular Medicine Division (W.M., A.N., C.C., K. Maslowski, G.C., T.K., S.A., J.H., R.L.W., H.C.H., D.M.K., J.G.), University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Monono', 'Affiliation': 'Department of Medicine, Division of Translational Medicine and Human Genetics (S.T., K. Monono, D.J.R.), University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Carcuffe', 'Affiliation': 'Cardiovascular Medicine Division (W.M., A.N., C.C., K. Maslowski, G.C., T.K., S.A., J.H., R.L.W., H.C.H., D.M.K., J.G.), University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Maslowski', 'Affiliation': 'Cardiovascular Medicine Division (W.M., A.N., C.C., K. Maslowski, G.C., T.K., S.A., J.H., R.L.W., H.C.H., D.M.K., J.G.), University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Gene', 'Initials': 'G', 'LastName': 'Chang', 'Affiliation': 'Cardiovascular Medicine Division (W.M., A.N., C.C., K. Maslowski, G.C., T.K., S.A., J.H., R.L.W., H.C.H., D.M.K., J.G.), University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Taisei', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Cardiovascular Medicine Division (W.M., A.N., C.C., K. Maslowski, G.C., T.K., S.A., J.H., R.L.W., H.C.H., D.M.K., J.G.), University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Saif', 'Initials': 'S', 'LastName': 'Anwaruddin', 'Affiliation': 'Cardiovascular Medicine Division (W.M., A.N., C.C., K. Maslowski, G.C., T.K., S.A., J.H., R.L.W., H.C.H., D.M.K., J.G.), University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hirshfeld', 'Affiliation': 'Cardiovascular Medicine Division (W.M., A.N., C.C., K. Maslowski, G.C., T.K., S.A., J.H., R.L.W., H.C.H., D.M.K., J.G.), University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Wilensky', 'Affiliation': 'Cardiovascular Medicine Division (W.M., A.N., C.C., K. Maslowski, G.C., T.K., S.A., J.H., R.L.W., H.C.H., D.M.K., J.G.), University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Howard C', 'Initials': 'HC', 'LastName': 'Herrmann', 'Affiliation': 'Cardiovascular Medicine Division (W.M., A.N., C.C., K. Maslowski, G.C., T.K., S.A., J.H., R.L.W., H.C.H., D.M.K., J.G.), University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Kolansky', 'Affiliation': 'Cardiovascular Medicine Division (W.M., A.N., C.C., K. Maslowski, G.C., T.K., S.A., J.H., R.L.W., H.C.H., D.M.K., J.G.), University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Rader', 'Affiliation': 'Department of Medicine, Division of Translational Medicine and Human Genetics (S.T., K. Monono, D.J.R.), University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Giri', 'Affiliation': 'Cardiovascular Medicine Division (W.M., A.N., C.C., K. Maslowski, G.C., T.K., S.A., J.H., R.L.W., H.C.H., D.M.K., J.G.), University of Pennsylvania Perelman School of Medicine, Philadelphia.'}]",Circulation. Genomic and precision medicine,['10.1161/CIRCGEN.119.002640']
515,31934821,Nattospes as Effective and Safe Functional Supplements in Management of Stroke.,"Stroke remains a major cause of human disability worldwide. Interventions and rehabilitation at the poststroke stage are critical for recovery. A single-blinded randomized controlled trial was conducted on 61 patients diagnosed with subacute stage of ischemic stroke. Ingestion of Nattospecs was tested as an adjuvant to support rehabilitation when combined with standard of care (SOC) treatment (electroacupuncture and Naatrapyl) (Trial group) and compared to SOC treatment alone (Control group). After 60 days, results showed that both Trial and Control groups achieved significant improvements in physical activities, blood pressure control, serum lipid panels, and quality of life. Nattospes as a food supplement has good supportive effects on treatment and rehabilitation after ischemic stroke by showing statistically significant improvement of stroke-related symptom in scores from modified Rankin, Orgogozo, and Barthel scales. In addition, Nattospes showed a good safety profile, with no adverse effects reported in both clinical and paraclinical parameters. This study indicated that Nattospes as nutraceutical supplement can be applied safely and effectively in the management of subacute stage ischemic stroke. The findings of the study may also encourage further extensive clinical trials to fully explore the prospect of Nattospes as a nutraceutical adjunct in the management of cardiovascular disease.",2020,"After 60 days, results showed that both Trial and Control groups achieved significant improvements in physical activities, blood pressure control, serum lipid panels, and quality of life.",['61 patients diagnosed with subacute stage of ischemic stroke'],"['standard of care (SOC) treatment (electroacupuncture and Naatrapyl', 'SOC treatment alone (Control group']","['physical activities, blood pressure control, serum lipid panels, and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}]","[{'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0200382', 'cui_str': 'Lipid panel (procedure)'}, {'cui': 'C0034380'}]",,0.0568047,"After 60 days, results showed that both Trial and Control groups achieved significant improvements in physical activities, blood pressure control, serum lipid panels, and quality of life.","[{'ForeName': 'Phuong T', 'Initials': 'PT', 'LastName': 'Pham', 'Affiliation': 'Tue Tinh Hospital-Vietnamese Academy of Traditional Medicine, Hanoi, VietNam.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': 'Nimni-Cordoba Tissue Engineering and Drug Discovery Laboratory, Division of Plastic and Reconstructive Surgery, Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Ba X', 'Initials': 'BX', 'LastName': 'Hoang', 'Affiliation': 'Nimni-Cordoba Tissue Engineering and Drug Discovery Laboratory, Division of Plastic and Reconstructive Surgery, Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}]",Journal of medicinal food,['10.1089/jmf.2019.0183']
516,31915029,Do cognitive aids reduce error rates in resuscitation team performance? Trial of emergency medicine protocols in simulation training (TEMPIST) in Australia.,"BACKGROUND


Resuscitation of patients with time-critical and life-threatening illness represents a cognitive challenge for emergency room (ER) clinicians. We designed a cognitive aid, the Emergency Protocols Handbook, to simplify clinical management and team processes. Resuscitation guidelines were reformatted into simple, single step-by-step pathways. This Australian randomised controlled trial tested the effectiveness of this cognitive aid in a simulated ER environment by observing team error rates when current resuscitation guidelines were followed, with and without the handbook.
METHODS


Resuscitation teams were randomised to manage two scenarios with the handbook and two without in a high-fidelity simulation centre. Each scenario was video-recorded. The primary outcome measure was error rates (the number of errors made out of 15 key tasks per scenario). Key tasks varied by scenario. Each team completed four scenarios and was measured on 60 key tasks. Participants were surveyed regarding their perception of the usefulness of the handbook.
RESULTS


Twenty-one groups performed 84 ER crisis simulations. The unadjusted error rate in the handbook group was 18.8% (121/645) versus 38.9% (239/615) in the non-handbook group. There was a statistically significant reduction of 54.0% (95% CI 49.9-57.9) in the estimated percentage error rate when the handbook was available across all scenarios 17.9% (95% CI 14.4-22.0%) versus 38.9% (95% CI 34.2-43.9%). Almost all (97%) participants said they would want to use this cognitive aid during a real medical crisis situation.
CONCLUSION


This trial showed that by following the step-by-step, linear pathways in the handbook, clinicians more than halved their teams' rate of error, across four simulated medical crises. The handbook improves team performance and enables healthcare teams to reduce clinical error rates and thus reduce harm for patients.
TRIAL REGISTRATION


ACTRN12616001456448 registered: www.anzctr.org.au. Trial site: http://emergencyprotocols.org.au/.",2020,There was a statistically significant reduction of 54.0% (95% CI 49.9-57.9) in the estimated percentage error rate when the handbook was available across all scenarios 17.9% (95% CI 14.4-22.0%) versus 38.9% (95% CI 34.2-43.9%).,"['patients with time-critical and life-threatening illness', 'Resuscitation teams', 'Australia']","['www.anzctr.org.au', 'emergency medicine protocols in simulation training (TEMPIST', 'http://emergencyprotocols.org.au']","['error rates (the number of errors made out of 15 key tasks per scenario', 'unadjusted error rate', 'percentage error rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332311', 'cui_str': 'With time (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0013964', 'cui_str': 'Emergency Medicine'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",84.0,0.236043,There was a statistically significant reduction of 54.0% (95% CI 49.9-57.9) in the estimated percentage error rate when the handbook was available across all scenarios 17.9% (95% CI 14.4-22.0%) versus 38.9% (95% CI 34.2-43.9%).,"[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Hall', 'Affiliation': 'University Centre for Rural Health, School of Medicine, Western Sydney University, 62 Uralba Street, Lismore, NSW, 2480, Australia. charlotte.hall@health.nsw.gov.au.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Robertson', 'Affiliation': 'Maclean District Hospital, Maclean, NSW, Australia.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Rolfe', 'Affiliation': 'School of Rural Health, The University of Sydney, University Centre for Rural Health, Lismore, Australia.'}, {'ForeName': 'Sharene', 'Initials': 'S', 'LastName': 'Pascoe', 'Affiliation': 'School of Rural Health, The University of Sydney, University Centre for Rural Health, Lismore, Australia.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Passey', 'Affiliation': 'School of Rural Health, The University of Sydney, University Centre for Rural Health, Lismore, Australia.'}, {'ForeName': 'Sabrina Winona', 'Initials': 'SW', 'LastName': 'Pit', 'Affiliation': 'University Centre for Rural Health, School of Medicine, Western Sydney University, 62 Uralba Street, Lismore, NSW, 2480, Australia. s.pit@westernsydney.edu.au.'}]",Human resources for health,['10.1186/s12960-019-0441-x']
517,31037288,HER2-Enriched Subtype and ERBB2 Expression in HER2-Positive Breast Cancer Treated with Dual HER2 Blockade.,"BACKGROUND


Identification of HER2-positive breast cancers with high anti-HER2 sensitivity could help de-escalate chemotherapy. Here, we tested a clinically applicable RNA-based assay that combines ERBB2 and the HER2-enriched (HER2-E) intrinsic subtype in HER2-positive disease treated with dual HER2-blockade without chemotherapy.
METHODS


A research-based PAM50 assay was applied in 422 HER2-positive tumors from five II-III clinical trials (SOLTI-PAMELA, TBCRC023, TBCRC006, PER-ELISA, EGF104090). In SOLTI-PAMELA, TBCRC023, TBCRC006, and PER-ELISA, all patients had early disease and were treated with neoadjuvant lapatinib or pertuzumab plus trastuzumab for 12-24 weeks. Primary outcome was pathological complete response (pCR). In EGF104900, 296 women with advanced disease were randomized to receive either lapatinib alone or lapatinib plus trastuzumab. Progression-free survival (PFS), overall response rate (ORR), and overall survival (OS) were evaluated.
RESULTS


A total of 305 patients with early and 117 patients with advanced HER2-positive disease were analyzed. In early disease, HER2-E represented 83.8% and 44.7% of ERBB2-high and ERBB2-low tumors, respectively. Following lapatinib and trastuzumab, the HER2-E and ERBB2 (HER2-E/ERBB2)-high group showed a higher pCR rate compared to the rest (44.5%, 95% confidence interval [CI] = 35.4% to 53.9% vs 11.6%, 95% CI = 6.9% to 18.0%; adjusted odds ratio [OR] = 6.05, 95% CI = 3.10 to 11.80, P < .001). Similar findings were observed with neoadjuvant trastuzumab and pertuzumab (pCR rate of 66.7% in HER2-E/ERBB2-high, 95% CI = 22.3% to 95.7% vs 14.7% in others, 95% CI = 4.9% to 31.1%; adjusted OR = 11.60, 95% CI = 1.66 to 81.10, P = .01). In the advanced setting, the HER2-E/ERBB2-high group was independently associated with longer PFS (hazard ratio [HR] = 0.52, 95% CI = 0.35 to 0.79, P < .001); higher ORR (16.3%, 95% CI = 8.9% to 26.2% vs 3.7%, 95% CI = 0.8% to 10.3%, P = .02); and longer OS (HR = 0.66, 95% CI = 0.44 to 0.97, P = .01).
CONCLUSIONS


Combining HER2-E subtype and ERBB2 mRNA into a single assay identifies tumors with high responsiveness to HER2-targeted therapy. This biomarker could help de-escalate chemotherapy in approximately 40% of patients with HER2-positive breast cancer.",2020,"Following lapatinib and trastuzumab, the HER2-E/ERBB2-high group showed a higher pCR rate compared to the rest (44.5% [95% CI = 35.4-53.9%] vs. 11.6% [95% CI = 6.9-18.0%]; adjusted odds ratio [","['296 women with advanced disease', 'patients with HER2-positive breast cancer', '305 patients with early and 117 patients with advanced HER2-positive disease']","['dual HER2 blockade', 'lapatinib alone or lapatinib plus trastuzumab', 'neoadjuvant lapatinib or pertuzumab plus trastuzumab', 'lapatinib and trastuzumab, the HER2-E/ERBB2-high']","['higher ORR', 'Progression-free survival (PFS), overall response rate (ORR) and overall survival (OS', 'longer PFS', 'HER2-enriched subtype and ERBB2 expression', 'pCR rate', 'longer OS (hazard', 'pathological complete response (pCR']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C4517703', 'cui_str': 'Three hundred and five'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",296.0,0.289702,"Following lapatinib and trastuzumab, the HER2-E/ERBB2-high group showed a higher pCR rate compared to the rest (44.5% [95% CI = 35.4-53.9%] vs. 11.6% [95% CI = 6.9-18.0%]; adjusted odds ratio [","[{'ForeName': 'Aleix', 'Initials': 'A', 'LastName': 'Prat', 'Affiliation': 'Department of Medical Oncology, Hospital Clínic de Barcelona, Spain.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Pascual', 'Affiliation': 'Department of Medical Oncology, Hospital Clínic de Barcelona, Spain.'}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'De Angelis', 'Affiliation': 'Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Gutierrez', 'Affiliation': 'Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Llombart-Cussac', 'Affiliation': 'Department of Medical Oncology, Hospital Arnau de Vilanova, Valencia, Spain.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortés', 'Affiliation': 'IOB Institute of Oncology, Quironsalud Group, Madrid & Barcelona, Spain.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Rexer', 'Affiliation': 'Department of Medicine, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Paré', 'Affiliation': 'Department of Medical Oncology, Hospital Clínic de Barcelona, Spain.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Forero', 'Affiliation': 'Department of Medicine, University of Alabama-Birmingham, Birmingham, AL.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Wolff', 'Affiliation': 'Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Serafín', 'Initials': 'S', 'LastName': 'Morales', 'Affiliation': 'Department of Medical Oncology, Hospital Universitari Arnau Vilanova, Lleida, Spain.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Adamo', 'Affiliation': 'Department of Medical Oncology, Hospital Clínic de Barcelona, Spain.'}, {'ForeName': 'Fara', 'Initials': 'F', 'LastName': 'Brasó-Maristany', 'Affiliation': 'Department of Medical Oncology, Hospital Clínic de Barcelona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vidal', 'Affiliation': 'Department of Medical Oncology, Hospital Clínic de Barcelona, Spain.'}, {'ForeName': 'Jamunarani', 'Initials': 'J', 'LastName': 'Veeraraghavan', 'Affiliation': 'Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Krop', 'Affiliation': 'Department of Medical Oncology, Dana Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Galván', 'Affiliation': 'Department of Medical Oncology, Hospital Clínic de Barcelona, Spain.'}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Pavlick', 'Affiliation': 'Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Bermejo', 'Affiliation': 'Department of Medical Oncology, Hospital Clínico de Valencia, Valencia, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Novartis Oncology, Basel, Switzerland.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Rodrik-Outmezguine', 'Affiliation': 'Novartis Oncology, Basel, Switzerland.'}, {'ForeName': 'Jorge S', 'Initials': 'JS', 'LastName': 'Reis-Filho', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Hilsenbeck', 'Affiliation': 'Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Mafalda', 'Initials': 'M', 'LastName': 'Oliveira', 'Affiliation': ""Breast Cancer Group, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Maria Vittoria', 'Initials': 'MV', 'LastName': 'Dieci', 'Affiliation': 'Department of Genetics, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Griguolo', 'Affiliation': 'Department of Genetics, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Fasani', 'Affiliation': ""Breast Cancer Group, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Nuciforo', 'Affiliation': ""Breast Cancer Group, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Joel S', 'Initials': 'JS', 'LastName': 'Parker', 'Affiliation': 'Department of Genetics, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'PierFranco', 'Initials': 'P', 'LastName': 'Conte', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Schiff', 'Affiliation': 'Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Guarneri', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.'}, {'ForeName': 'C Kent', 'Initials': 'CK', 'LastName': 'Osborne', 'Affiliation': 'Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Mothaffar F', 'Initials': 'MF', 'LastName': 'Rimawi', 'Affiliation': 'Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX.'}]",Journal of the National Cancer Institute,['10.1093/jnci/djz042']
518,31917607,Pitolisant for Daytime Sleepiness in Patients with Obstructive Sleep Apnea Who Refuse Continuous Positive Airway Pressure Treatment. A Randomized Trial.,"Rationale:  Excessive daytime sleepiness is a common disabling symptom in obstructive sleep apnea syndrome. Objectives:  To evaluate the efficacy and safety of pitolisant, a selective histamine H3 receptor antagonist with wake-promoting effects, for the treatment of daytime sleepiness in patients with moderate to severe obstructive sleep apnea refusing continuous positive airway pressure treatment. Methods:  In an international, multicenter, double-blind, randomized (3:1), placebo-controlled, parallel-design trial, pitolisant was individually titrated at up to 20 mg/d over 12 weeks. The primary endpoint was the change in the Epworth Sleepiness Scale score. Key secondary endpoints were maintenance of wakefulness assessed on the basis of the Oxford Sleep Resistance test, safety, Clinical Global Impression of severity, patient's global opinion, EuroQol quality-of-life questionnaire, and Pichot fatigue questionnaire. Measurements and Main Results:  A total of 268 patients with obstructive sleep apnea (75% male; mean age, 52 yr; apnea-hypopnea index, 49/h; baseline sleepiness score, 15.7) were randomized (200 to pitolisant and 68 to placebo) and analyzed on an intention-to-treat basis. The Epworth Sleepiness Scale score was reduced more with pitolisant than with placebo (-2.8; 95% confidence interval, -4.0 to -1.5;  P  < 0.001). Wake maintenance tests were not improved. The Pichot fatigue score was reduced with pitolisant. The overall impact of pitolisant was confirmed by both physicians' and patients' questionnaires. Adverse event incidence, mainly headache, insomnia, nausea, and vertigo, was similar in the pitolisant and placebo groups (29.5% and 25.4%, respectively), with no cardiovascular or other significant safety concerns. Conclusions:  Pitolisant significantly reduced self-reported daytime sleepiness and fatigue and improved patient-reported outcomes and physician disease severity assessment in sleepy patients with obstructive sleep apnea refusing or nonadherent to continuous positive airway pressure.Clinical trial registered with www.clinicaltrials.gov (NCT01072968) and EU Clinical Trials Register (EudraCT 2009-017251-94).",2020,"Adverse event incidence, mainly headache, insomnia, nausea, and vertigo, was similar in the pitolisant and placebo groups (29.5% and 25.4%, respectively), with no cardiovascular or other significant safety concerns.
","['268 obstructive sleep apnea patients (75% male; mean age: 52 years, Apnea-hypopnea index: 49/hour, baseline sleepiness score: 15.7) were randomized (200 pitolisant; 68', 'obstructive sleep apnea syndrome', 'Obstructive Sleep Apnea Patients Refusing CPAP', 'sleepy patients with obstructive sleep apnea refusing or non-adherent to continuous positive airway pressure', 'patients with moderate to severe obstructive sleep apnea refusing continuous positive airway pressure treatment']",['placebo'],"['Epworth Sleepiness score', 'Adverse event incidence, mainly headache, insomnia, nausea, and vertigo', 'Daytime Sleepiness', 'self-reported daytime sleepiness, fatigue', 'daytime sleepiness', ""maintenance of wakefulness assessed by the Oxford Sleep Resistance Test, safety, clinical global impressions of severity, patient's global opinion, EQ-5D quality-of-life, and Pichot Fatigue questionnaire scores"", 'Pichot fatigue score', 'change in the Epworth Sleepiness score']","[{'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3529928', 'cui_str': 'Pitolisant (substance)'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0013144', 'cui_str': 'Drowsy (finding)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042571', 'cui_str': 'Spinning Sensation'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0043012', 'cui_str': 'Wakefulnesses'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0871010', 'cui_str': 'Opinions'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",268.0,0.277263,"Adverse event incidence, mainly headache, insomnia, nausea, and vertigo, was similar in the pitolisant and placebo groups (29.5% and 25.4%, respectively), with no cardiovascular or other significant safety concerns.
","[{'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Dauvilliers', 'Affiliation': 'National Reference Center for Narcolepsy, Sleep and Wake Unit, Department of Neurology, Gui-de-Chauliac Hospital, Montpellier University Hospital, Montpellier, France.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Verbraecken', 'Affiliation': 'Multidisciplinary Sleep Disorders Center, Antwerp University Hospital and University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Partinen', 'Affiliation': 'Helsinki Sleep Clinic, Vitalmed Research Center, Helsinki, Finland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hedner', 'Affiliation': 'Sleep and Vigilance Laboratory, Department of Internal Medicine, University of Göteborg, Sahlgrenska University Hospital, University of Göteborg, Göteborg, Sweden.'}, {'ForeName': 'Tarja', 'Initials': 'T', 'LastName': 'Saaresranta', 'Affiliation': 'Sleep Research Center, Department of Pulmonary Diseases and Clinical Allergology, University of Turku, Turku, Finland.'}, {'ForeName': 'Ognian', 'Initials': 'O', 'LastName': 'Georgiev', 'Affiliation': 'Pulmonology Unit, Department of Internal Medicine, Alexandrovska Hospital Medical University, Sofia, Bulgaria.'}, {'ForeName': 'Rumen', 'Initials': 'R', 'LastName': 'Tiholov', 'Affiliation': 'Department of Internal Diseases, Sveti Ivan Rilski Multiprofile Hospital for Active Treatment, Kozloduy, Bulgaria.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Lecomte', 'Affiliation': 'Bioprojet, 30 rue Francs Bourgois, Paris, France.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Tamisier', 'Affiliation': 'Hypoxia-Physiopathology (HP2) Laboratory, INSERM U1042, University Grenoble Alpes, Grenoble, France; and.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lévy', 'Affiliation': 'Hypoxia-Physiopathology (HP2) Laboratory, INSERM U1042, University Grenoble Alpes, Grenoble, France; and.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Scart-Gres', 'Affiliation': 'Bioprojet, 30 rue Francs Bourgois, Paris, France.'}, {'ForeName': 'Jeanne-Marie', 'Initials': 'JM', 'LastName': 'Lecomte', 'Affiliation': 'Bioprojet, 30 rue Francs Bourgois, Paris, France.'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Schwartz', 'Affiliation': 'Bioprojet, 30 rue Francs Bourgois, Paris, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Pépin', 'Affiliation': 'Hypoxia-Physiopathology (HP2) Laboratory, INSERM U1042, University Grenoble Alpes, Grenoble, France; and.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201907-1284OC']
519,31270896,Impact of different exercise training modalities on energy and nutrient intake and food consumption in sedentary middle-aged adults: a randomised controlled trial.,"BACKGROUND


Exercise could influence energy and macronutrient intake, which could have an important role on body composition changes in response to exercise. The present study aimed to investigate the effects of different training modalities in energy and macronutrient intake, and whether changes in energy and macronutrient intake influences changes in body composition in response to different training modalities.
METHODS


A 12-week randomised controlled trial was conducted. Eighty middle-aged sedentary adults were randomised to: (i) a control group; (ii) physical activity recommendation from the World Health Organization; (iii) high-intensity interval training; and (iv) whole-body electromyostimulation training. Dietary intake was assessed using the average of three 24-h recalls.
RESULTS


High-intensity interval training and whole-body electromyostimulation training groups showed lower fibre intake and higher dietary energy density. Our results showed a negative association was found between changes in energy intake and changes in lean mass index. No association was found between changes in protein intake and changes in lean mass index.
CONCLUSIONS


In conclusion, we observed a higher dietary energy density and lower fibre intake in high-intensity training groups.",2020,"RESULTS


High-intensity interval training and whole-body electromyostimulation training groups showed lower fibre intake and higher dietary energy density.","['Eighty middle-aged sedentary adults', 'sedentary middle-aged adults']","['control group; (ii) physical activity recommendation from the World Health Organization; (iii) high-intensity interval training; and (iv) whole-body electromyostimulation training', 'exercise training modalities']","['dietary energy density and lower fibre intake', 'Dietary intake', 'fibre intake and higher dietary energy density', 'energy intake and changes in lean mass index', 'protein intake and changes in lean mass index', 'energy and nutrient intake and food consumption']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",80.0,0.0423244,"RESULTS


High-intensity interval training and whole-body electromyostimulation training groups showed lower fibre intake and higher dietary energy density.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Jurado-Fasoli', 'Affiliation': 'Departament of Medical Physiology, School of Medicine, University of Granada, Granada, Spain.'}, {'ForeName': 'F J', 'Initials': 'FJ', 'LastName': 'Amaro-Gahete', 'Affiliation': 'Departament of Medical Physiology, School of Medicine, University of Granada, Granada, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'De-la-O', 'Affiliation': 'Departament of Medical Physiology, School of Medicine, University of Granada, Granada, Spain.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Castillo', 'Affiliation': 'Departament of Medical Physiology, School of Medicine, University of Granada, Granada, Spain.'}]",Journal of human nutrition and dietetics : the official journal of the British Dietetic Association,['10.1111/jhn.12673']
520,31595489,The Healthy Heart-Mind Trial: Randomized Controlled Trial of Melatonin for Prevention of Delirium.,"OBJECTIVES


Delirium is a serious medical condition with increased incidence in at-risk surgical populations. We sought to determine if melatonin use reduces the incidence of delirium in individuals undergoing major cardiac surgery.
DESIGN


Randomized double-blind placebo-controlled clinical trial (two arms, 1:1 allocation, parallel design).
SETTING


The trial took place in two metropolitan hospitals (public tertiary and private) in Perth, Western Australia.
PARTICIPANTS


We recruited 210 adults aged 50 years or older who were due to undergo coronary artery bypass grafting or valve replacement surgery.
INTERVENTION


Participants were randomly assigned (1:1) to 7 days of treatment with melatonin 3 mg at night or matching placebo, starting 2 days before the surgery.
MEASUREMENTS


The primary outcome of interest was incident delirium within 7 days of surgery as assessed via daily clinical assessment that included the Confusion Assessment Method. Secondary outcomes of interest included duration and severity of delirium, length of hospital stay, cognitive function, and mood and anxiety symptoms at discharge and 3 months after the surgery.
RESULTS


The groups were well balanced for demographic and clinical parameters. Forty-two participants developed delirium, but it was evenly distributed between the groups (melatonin 21/98, 21.4%; placebo 21/104, 20.2%; adjusted odds ratio [OR] = .78; 95% confidence interval [CI] = .35-1.75). The median duration of delirium was 3 (interquartile range [IQR] = 2-4) and 2 (IQR = 1-3) days for people treated with melatonin and placebo, respectively (z = -1.03; P = .304). A similar proportion of participants experienced severe episodes of delirium in each group (melatonin 9/21, 42.9% vs placebo 6/21, 28.6%; χ 2  = .93; P = .334; adjusted OR = 1.98; 95% CI = .40-9.78). The groups did not differ in terms of length of stay, mood, anxiety, and cognitive performance.
CONCLUSION


The findings of this randomized double-blind placebo-controlled trial do not support the prophylactic use of melatonin to prevent delirium after major cardiac surgery. J Am Geriatr Soc 68:112-119, 2019.",2020,"The groups did not differ in terms of length of stay, mood, anxiety, and cognitive performance.
","['two metropolitan hospitals (public tertiary and private) in Perth, Western Australia', 'We recruited 210 adults aged 50\u2009years or older who were due to undergo coronary artery bypass grafting or valve replacement surgery', 'individuals undergoing major cardiac surgery', 'Healthy Heart-Mind Trial', 'delirium after major cardiac surgery']","['melatonin 3 mg at night or matching placebo', 'placebo', 'melatonin', 'Melatonin', 'melatonin and placebo']","['median duration of delirium', 'delirium', 'incident delirium within 7\u2009days of surgery as assessed via daily clinical assessment that included the Confusion Assessment Method', 'length of stay, mood, anxiety, and cognitive performance', 'duration and severity of delirium, length of hospital stay, cognitive function, and mood and anxiety symptoms at discharge and 3 months after the surgery', 'severe episodes of delirium']","[{'cui': 'C0020029', 'cui_str': 'Hospitals, Metropolitan'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}]","[{'cui': 'C1124060', 'cui_str': 'Melatonin 3 MG'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0009676', 'cui_str': 'Confusional State'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}]",210.0,0.809496,"The groups did not differ in terms of length of stay, mood, anxiety, and cognitive performance.
","[{'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Ford', 'Affiliation': 'Medical School, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Flicker', 'Affiliation': 'Medical School, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Kelly', 'Affiliation': 'Medical School, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Hema', 'Initials': 'H', 'LastName': 'Patel', 'Affiliation': 'Medical School, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Jurgen', 'Initials': 'J', 'LastName': 'Passage', 'Affiliation': 'School of Medicine, University of Notre Dame and Department of Cardiothoracic Surgery, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Wibrow', 'Affiliation': 'Medical School, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Anstey', 'Affiliation': 'Medical School, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Edwards', 'Affiliation': 'Department of Cardiothoracic Surgery, Fiona Stanley Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Osvaldo P', 'Initials': 'OP', 'LastName': 'Almeida', 'Affiliation': 'Medical School, University of Western Australia, Perth, Western Australia, Australia.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16162']
521,31600031,Effectiveness of dry heat application on ease of venepuncture in children with difficult intravenous access: A randomized controlled trial.,"PURPOSE


To assess the efficacy of dry heat application in children with difficult intravenous (IV) access.
DESIGN AND METHODS


A randomized controlled trial was conducted in the pediatric wards of a tertiary care hospital in a Metropolitan city in South India. Based on inclusion and exclusion criteria, children in the age group of 5-18 years were randomized into intervention and control groups of 42 children each. The intervention was an electric heating pad (40°C) applied at the site of the identified IV access for 10 min before IV insertion. Outcomes included the number of IV attempts, the time required to access the IV line, and the discomfort level of the child expressed in terms of the Oucher scale.
RESULTS


With respect to the number of attempts taken to achieve an IV access, all children in the intervention group only required one attempt, whereas only 29% of those in the control group required a single attempt (p < .001), X 2  (1, 84) = 43.67, p < .001. The mean time (in seconds) to insert an IV line was lower in the intervention group (M = 64.56, standard deviation [SD] = 28.32) than in the control group (M = 110.70, SD = 51.54), t (82) = 5.09, p < .001. Children in the intervention group were 45.2 percentage points more likely to experience a discomfort level of ""little hurt"" as compared to their counterparts in the control group, X 2  (1, 84) = 18.02, p < .001. Results from regression analyses supported the unadjusted outcomes comparisons between the two groups.
PRACTICE IMPLICATIONS


Dry heat application before IV line insertion significantly improves the ease of venepuncture and reduces the pain perceived by the patient. This method of IV cannulation can be adopted in children with problematic IV access.",2020,"Children in the intervention group were 45.2 percentage points more likely to experience a discomfort level of ""little hurt"" as compared to their counterparts in the control group, X 2  (1, 84) = 18.02, p < .001.","['pediatric wards of a tertiary care hospital in a Metropolitan city in South India', 'children with difficult intravenous access', 'children with difficult intravenous (IV) access', 'children in the age group of 5-18 years', 'children with problematic IV access']","['dry heat application', 'electric heating pad']","['number of IV attempts, the time required to access the IV line, and the discomfort level of the child expressed in terms of the Oucher scale', 'mean time (in seconds) to insert an IV line', 'pain', 'discomfort level of ""little hurt']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0181157', 'cui_str': 'Electric heating pad, device (physical object)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0222045'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0700321', 'cui_str': 'Small (qualifier value)'}]",42.0,0.0583214,"Children in the intervention group were 45.2 percentage points more likely to experience a discomfort level of ""little hurt"" as compared to their counterparts in the control group, X 2  (1, 84) = 18.02, p < .001.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Suchitra', 'Affiliation': 'Department of Pediatric Nursing, ESIC College of Nursing, Gulbarga, Karnataka, India.'}, {'ForeName': 'Ranjini', 'Initials': 'R', 'LastName': 'Srinivasan', 'Affiliation': ""Department of Pediatric Medicine, St. John's Medical College Hospital, Bangalore, Karnataka, India.""}]",Journal for specialists in pediatric nursing : JSPN,['10.1111/jspn.12273']
522,31012819,Effects of Exercise With and Without Energy Replacement on Substrate Utilization in the Fasting State.,"Objective:  The present study aimed to examine the interactive effect of exercise and energy balance on energy expenditure and substrate utilization. Method:  Seven men and 7 women underwent three 2-day experimental protocols in a random order. Each protocol consisted of no exercise (NE), exercise only (EO), or exercise with a matched energy replacement (ER) on day 1 followed by metabolic testing that occurred after a 12-hour overnight fasting on day 2. Both EO and ER involved treadmill running at 60% maximal oxygen uptake (VO 2 max) that induced an energy expenditure of ∼ 500 kcal. The replacement meal used in ER contained ∼ 500 kcal made up of 45% carbohydrate, 30% fat, and 25% protein. During metabolic testing, oxygen uptake (VO 2 ), heart rate (HR), respiratory exchange ratio (RER), and rates of carbohydrate (COX) and fat oxidation (FOX) were determined in three successive 15-minute periods including rest and exercise at 50% and 70% VO 2 max. Results:  No differences in VO 2  and HR were found at rest among NE, EO, and ER. However, RER was lower in EO than NE (0.840 ± 0.014 vs 0.889 ± 0.012,  p  < 0.05), COX (g·min -1 ) was lower in ER than NE (0.144 ± 0.016 vs 0.197 ± 0.019,  p  < 0.05), and FOX (g·min -1 ) was higher in EO or ER than NE (0.054 ± 0.010 or 0.057 ± 0.009 vs 0.034 ± 0.007,  p  < 0.05). No treatment effects were observed for all variables at either intensity. Conclusions:  This study demonstrates that an exercise of moderate intensity can increase resting fat oxidation even when the exercise-induced energy expenditure is balanced by energy intake. This finding suggests that muscle action is vital in augmenting fat utilization.",2020,"No differences in VO 2  and HR were found at rest among NE, EO, and ER.",['Seven men and 7 women underwent three 2-day experimental protocols in a random order'],"['no exercise (NE), exercise only (EO), or exercise with a matched energy replacement (ER', 'exercise and energy balance', 'Exercise With and Without Energy Replacement']","['FOX', 'RER', 'oxygen uptake (VO 2 ), heart rate (HR), respiratory exchange ratio (RER), and rates of carbohydrate (COX) and fat oxidation (FOX', 'Substrate Utilization', 'VO 2  and HR']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]","[{'cui': 'C0016633', 'cui_str': 'Foxes'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient (observable entity)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0042153', 'cui_str': 'use'}]",,0.051252,"No differences in VO 2  and HR were found at rest among NE, EO, and ER.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Human Performance Laboratory, Department of Health and Exercise Science, The College of New Jersey, Ewing, New Jersey, USA.'}, {'ForeName': 'Saif B', 'Initials': 'SB', 'LastName': 'Hasan', 'Affiliation': 'Human Performance Laboratory, Department of Health and Exercise Science, The College of New Jersey, Ewing, New Jersey, USA.'}, {'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Ellis', 'Affiliation': 'Human Performance Laboratory, Department of Health and Exercise Science, The College of New Jersey, Ewing, New Jersey, USA.'}, {'ForeName': 'Ira T', 'Initials': 'IT', 'LastName': 'Vought', 'Affiliation': 'Human Performance Laboratory, Department of Health and Exercise Science, The College of New Jersey, Ewing, New Jersey, USA.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Ratamess', 'Affiliation': 'Human Performance Laboratory, Department of Health and Exercise Science, The College of New Jersey, Ewing, New Jersey, USA.'}, {'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Bush', 'Affiliation': 'Human Performance Laboratory, Department of Health and Exercise Science, The College of New Jersey, Ewing, New Jersey, USA.'}, {'ForeName': 'Avery D', 'Initials': 'AD', 'LastName': 'Faigenbaum', 'Affiliation': 'Human Performance Laboratory, Department of Health and Exercise Science, The College of New Jersey, Ewing, New Jersey, USA.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2019.1605549']
523,31150711,"A randomized phase 3b/4 study to evaluate concomitant use of topical ivermectin 1% cream and doxycycline 40-mg modified-release capsules, versus topical ivermectin 1% cream and placebo in the treatment of severe rosacea.","BACKGROUND


Randomized controlled studies of combination therapies in rosacea are limited.
OBJECTIVE


Evaluate the efficacy and safety of combining ivermectin 1% cream (IVM) and doxycycline 40-mg modified-release capsules (ie, 30-mg immediate-release and 10-mg delayed-release beads) (DMR) versus IVM and placebo for treatment of severe rosacea.
METHODS


This 12-week, multicenter, randomized, investigator-blinded, parallel-group comparative study randomized adult subjects with severe rosacea (Investigator's Global Assessment [IGA] score, 4) to receive either IVM and DMR (combination arm) or IVM and placebo (monotherapy).
RESULTS


A total of 273 subjects participated. IVM and DMR displayed superior efficacy in reduction of inflammatory lesions (-80.3% vs -73.6% for monotherapy [P = .032]) and IGA score (P = .032). Combination therapy had a faster onset of action as of week 4; it significantly increased the number of subjects achieving an IGA score of 0 (11.9% vs 5.1% [P = .043]) and 100% lesion reduction (17.8% vs 7.2% [P = .006]) at week 12. Both treatments reduced the Clinician's Erythema Assessment score, stinging/burning, flushing episodes, Dermatology Life Quality Index score, and ocular signs/symptoms and were well tolerated.
LIMITATIONS


The duration of the study prevented evaluation of potential recurrences or further improvements.
CONCLUSION


Combining IVM and DMR can produce faster responses, improve response rates, and increase patient satisfaction in cases of severe rosacea.",2020,"Both treatments reduced the Clinician's Erythema Assessment score, stinging/burning, flushing episodes, Dermatology Life Quality Index and ocular signs/symptoms, and were well-tolerated.
","['273 subjects participated', 'severe rosacea', ""adult subjects with severe rosacea (Investigator's Global Assessment [IGA]=4) to either""]","['IVM and DMR (combination arm) or IVM and PBO (monotherapy', 'topical ivermectin 1% cream and doxycycline 40 mg modified-release capsules versus topical ivermectin 1% cream and placebo', 'ivermectin 1% cream (IVM) and doxycycline 40 mg modified-release capsules ∗  (DMR) versus IVM and placebo (PBO']","[""Clinician's Erythema Assessment score, stinging/burning, flushing episodes, Dermatology Life Quality Index and ocular signs/symptoms, and were well-tolerated"", 'number of subjects achieving IGA 0', 'response rates', 'IGA score', 'inflammatory lesions']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0035854', 'cui_str': 'Rosacea'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C4544813', 'cui_str': 'Modified-release'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0038340', 'cui_str': 'Stings'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C3872830', 'cui_str': 'Inflammatory lesion'}]",273.0,0.112432,"Both treatments reduced the Clinician's Erythema Assessment score, stinging/burning, flushing episodes, Dermatology Life Quality Index and ocular signs/symptoms, and were well-tolerated.
","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schaller', 'Affiliation': 'Department of Dermatology, Tübingen University Hospital, Tübingen, Germany. Electronic address: martin.schaller@med.uni-tuebingen.de.'}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Kemény', 'Affiliation': 'Department of Dermatology and Allergology, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Blanka', 'Initials': 'B', 'LastName': 'Havlickova', 'Affiliation': 'Dermatology Center, Prague, Czech Republic.'}, {'ForeName': 'J Mark', 'Initials': 'JM', 'LastName': 'Jackson', 'Affiliation': 'Division of Dermatology, University of Louisville, Louisville, Kentucky; Forefront Dermatology, Louisville, Kentucky.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Ambroziak', 'Affiliation': 'Ambroziak Clinic, Warsaw, Poland.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lynde', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': 'SKiN Centre for Dermatology, Peterborough, Ontario, Canada.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Remenyik', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Del Rosso', 'Affiliation': 'JDR Dermatology Research/Thomas Dermatology, Las Vegas, Nevada.'}, {'ForeName': 'Jolanta', 'Initials': 'J', 'LastName': 'Weglowska', 'Affiliation': 'Niepubliczny Zakład Opieki Zdrowotnej multiMedica, Wrocław, Poland.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Chavda', 'Affiliation': 'Medical Evidence, Galderma S.A., Vevey, Switzerland.'}, {'ForeName': 'Nabil', 'Initials': 'N', 'LastName': 'Kerrouche', 'Affiliation': 'Galderma R&D, Sophia Antipolis, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Dirschka', 'Affiliation': 'CentroDerm-Clinic, Wuppertal, Germany; Faculty of Health, University of Witten-Herdecke, Witten, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Johnson Dermatology, Fort Smith, Arkansas.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.05.063']
524,31175909,"Long-term efficacy and safety of brodalumab in the treatment of psoriasis: 120-week results from the randomized, double-blind, placebo- and active comparator-controlled phase 3 AMAGINE-2 trial.","BACKGROUND


Randomized controlled trials have shown the efficacy and safety of brodalumab in patients with moderate to severe plaque psoriasis.
OBJECTIVE


To evaluate the efficacy and safety of brodalumab through 120 weeks of treatment in the AMAGINE-2 trial.
METHODS


Patients received ustekinumab through week 52 followed by brodalumab 210 mg every 2 weeks, continuous brodalumab 210 mg every 2 weeks, or any dose of brodalumab. Efficacy data were reported through 120 weeks by using observed data, last observation carried forward, and nonresponder imputation analyses.
RESULTS


Of patients who received brodalumab 210 mg every 2 weeks, 84.4%, 75.6%, and 61.1% achieved 75%, 90%, and 100% improvement from baseline in Psoriasis Area and Severity Index at 120 weeks (observed data analysis), respectively. Patients who received brodalumab 210 mg every 2 weeks after receiving ustekinumab through 52 weeks achieved a similar skin clearance response as patients who received continuous brodalumab 210 mg every 2 weeks. Safety through 120 weeks was comparable to that of the blinded study periods.
LIMITATIONS


A large number of discontinuations toward the end of the study (31% in the final 6 months) were due to early termination and led to differences between observed data and nonresponder imputation results.
CONCLUSIONS


Brodalumab is well tolerated and showed robust efficacy for more than 2 years.",2020,"Patients who received brodalumab 210 mg Q2W after receiving ustekinumab through 52 weeks achieved similar skin clearance responses as patients who received continuous brodalumab 210 mg Q2W. Safety through 120 weeks was comparable to that of the blinded study periods.
","['patients with moderate-to-severe plaque psoriasis', 'psoriasis']","['placebo', 'continuous brodalumab 210 mg Q2W. Safety', 'brodalumab 210 mg every 2 weeks (Q2W), continuous brodalumab 210 mg Q2W, or any dose of brodalumab', 'brodalumab', 'brodalumab 210 mg Q2W']","['skin clearance responses', 'psoriasis area and severity index', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C3491331', 'cui_str': 'brodalumab'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.380561,"Patients who received brodalumab 210 mg Q2W after receiving ustekinumab through 52 weeks achieved similar skin clearance responses as patients who received continuous brodalumab 210 mg Q2W. Safety through 120 weeks was comparable to that of the blinded study periods.
","[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Puig', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain. Electronic address: lpuig@santpau.cat.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Bachelez', 'Affiliation': 'Sorbonne Paris Cité Université Paris Diderot, Paris, France; AP-HP Hôpital Saint-Louis, Paris, France.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Sobell', 'Affiliation': 'SkinCare Physicians, Chestnut Hill, MA.'}, {'ForeName': 'Abby A', 'Initials': 'AA', 'LastName': 'Jacobson', 'Affiliation': 'Ortho Dermatologics, Bridgewater, NJ.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.05.095']
525,31175910,Immunogenicity and skin clearance recapture in clinical studies of brodalumab.,"BACKGROUND


Antidrug antibodies (ADAs) may change pharmacokinetic or pharmacodynamic profiles of biologic therapies, potentially decreasing efficacy.
OBJECTIVE


To evaluate the potential effects of brodalumab immunogenicity on safety, efficacy, and retreatment.
METHODS


Data from 1 phase 2 and 3 phase 3 studies of brodalumab in psoriasis were analyzed.
RESULTS


Overall, 2.7% of patients had positive test results for binding ADAs after receiving brodalumab; ADAs were transient in 1.4% of patients, and there were no neutralizing ADAs. Among ADA-positive patients, 60.0% (3/5) achieved a static physician's global assessment score of 0 or 1 at week 12 in the group receiving the brodalumab 210 mg every 2 weeks, compared with 79.1% (1131/1429) of ADA-negative patients. All patients (100%) who experienced return of disease and were retreated with brodalumab 210 mg every 2 weeks (none were ADA positive) achieved at least a 75% improvement in Psoriasis Area And Severity Index, ≥90% of whom regained response by week 8 of retreatment. Hypersensitivity reactions were less frequent with brodalumab than with placebo. Injection site reactions occurred in 1.8% of patients treated with brodalumab versus 2% of patients treated with ustekinumab.
LIMITATIONS


Retreatment could be assessed in only 1 phase 3 brodalumab study.
CONCLUSION


Brodalumab compares favorably with other biologics in terms of immunogenicity and high rates of efficacy recapture upon retreatment.",2020,"Among ADA-positive patients, 60.0% (3/5) achieved static physician's global assessment score of 0 or 1 at week 12 in the brodalumab 210 mg every 2 weeks (Q2W) group, compared with 79.1% (1131/1429) of ADA-negative patients.",['Data from one phase 2 and three phase 3 studies of brodalumab in psoriasis were analyzed'],"['placebo', 'brodalumab 210 mg Q2W']","['safety, efficacy, and retreatment', 'Hypersensitivity reactions', 'neutralizing ADA', 'binding ADA', ""static physician's global assessment score"", 'psoriasis area and severity index', 'Immunogenicity and Skin Clearance Recapture', 'Injection-site reactions']","[{'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3491331', 'cui_str': 'brodalumab'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3491331', 'cui_str': 'brodalumab'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}]",,0.0762853,"Among ADA-positive patients, 60.0% (3/5) achieved static physician's global assessment score of 0 or 1 at week 12 in the brodalumab 210 mg every 2 weeks (Q2W) group, compared with 79.1% (1131/1429) of ADA-negative patients.","[{'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Bagel', 'Affiliation': 'Psoriasis Treatment Center of Central New Jersey, East Windsor, New Jersey. Electronic address: dreamacres1@aol.com.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Israel', 'Affiliation': 'Bausch Health, Bridgewater, New Jersey.'}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Jacobson', 'Affiliation': 'Ortho Dermatologics, Bridgewater, New Jersey.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.05.094']
526,31789302,"Plyometric exercises: subsequent changes of weight-bearing symmetry, muscle strength and walking performance in children with unilateral cerebral palsy.","OBJECTIVE


To evaluate the subsequent effects of plyometric training on weight-bearing symmetry, muscle strength, and gait performance in children with unilateral cerebral palsy.
METHODS


Thirty-nine children with spastic hemiplegia (age 8-12 years) were randomly divided into either the PLYO group ( n =19, received a 30-minute plyometric exercise program plus the traditional physical rehabilitation, twice/week for eight consecutive weeks) or Non-PLYO group ( n =20, received the traditional physical rehabilitation only). The weight-bearing symmetry index (WB-SI), maximum isometric muscle strength (MIMS) of quadriceps and hamstring muscles, and spatial-temporal gait parameters were assessed pre and post-intervention.
RESULTS


From pre- to post-intervention, changes of WB-SI among PLYO and Non-PLYO groups did not differ significantly ( P =.81; hindfoot and  P =.23; forefoot). MIMS of quadriceps and hamstring muscles at 90° knee flexion ( P =.008 and .013 respectively) increased significantly in PLYO compared to Non-PLYO group. Walking speed ( P =.033), stride length ( P =.002), and step time ( P <.001) improved markedly in PLYO group more than in Non-PLYO group. The proportion of single leg support ( P =.14) among PLYO and Non-PLYO groups did not differ significantly.
CONCLUSION


Addition of plyometric exercises to the physical rehabilitation programs of children with unilateral CP could achieve greater improvement in muscles strength and walking performance, but not in WB-SI.",2019,MIMS of quadriceps and hamstring muscles at 90° knee flexion ( P =.008 and .013 respectively) increased significantly in PLYO compared to Non-PLYO group.,"['Thirty-nine children with spastic hemiplegia (age 8-12 years', 'children with unilateral CP', 'children with unilateral cerebral palsy']","['plyometric exercise program plus the traditional physical rehabilitation, twice/week for eight consecutive weeks) or Non-PLYO group ( n =20, received the traditional physical rehabilitation only', 'plyometric exercises', 'plyometric training', 'Plyometric exercises']","['muscles strength and walking performance', 'stride length', 'step time', 'changes of WB-SI', 'Walking speed', 'weight-bearing symmetry index (WB-SI), maximum isometric muscle strength (MIMS) of quadriceps and hamstring muscles, and spatial-temporal gait parameters', 'weight-bearing symmetry, muscle strength, and gait performance', 'proportion of single leg support', 'MIMS of quadriceps and hamstring muscles', 'weight-bearing symmetry, muscle strength and walking performance']","[{'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0154694', 'cui_str': 'Hemiplegia, Spastic'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}]","[{'cui': 'C3178799', 'cui_str': 'Plyometric Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0584895', 'cui_str': 'Hamstring Muscles'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",39.0,0.0174446,MIMS of quadriceps and hamstring muscles at 90° knee flexion ( P =.008 and .013 respectively) increased significantly in PLYO compared to Non-PLYO group.,"[{'ForeName': 'Ragab K', 'Initials': 'RK', 'LastName': 'Elnaggar', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Mohammed F', 'Initials': 'MF', 'LastName': 'Elbanna', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Waleed S', 'Initials': 'WS', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Bader A', 'Initials': 'BA', 'LastName': 'Alqahtani', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}]",Journal of musculoskeletal & neuronal interactions,[]
527,31621901,GAPcare: The Geriatric Acute and Post-Acute Fall Prevention Intervention in the Emergency Department: Preliminary Data.,"OBJECTIVES


We aimed to describe a new multidisciplinary team fall prevention intervention for older adults who seek care in the emergency department (ED) after having a fall, assess its feasibility and acceptability, and review lessons learned during its initiation.
DESIGN


Single-blind randomized controlled pilot study.
SETTING


Two urban academic EDs PARTICIPANTS: Adults 65 years old or older (n = 110) who presented to the ED within 7 days of a fall.
INTERVENTION


Participants were randomized to a usual care (UC) and an intervention (INT) arm. Participants in the INT arm received a brief medication therapy management session delivered by a pharmacist and a fall risk assessment and plan by a physical therapist (PT). INT participants received referrals to outpatient services (eg, home safety evaluation, outpatient PT).
MEASUREMENTS


We used participant, caregiver, and clinician surveys, as well as electronic health record review, to assess the feasibility and acceptability of the intervention.
RESULTS


Of the 110 participants, the median participant age was 81 years old, 67% were female, 94% were white, and 16.3% had cognitive impairment. Of the 55 in the INT arm, all but one participant received the pharmacy consult (98.2%); the PT consult was delivered to 83.6%. Median consult time was 20 minutes for pharmacy and 20 minutes for PT. ED length of stay was not increased in the INT arm: UC 5.25 hours vs INT 5.0 hours (P < .94). After receiving the Geriatric Acute and Post-acute Fall Prevention Intervention (GAPcare), 100% of participants and 97.6% of clinicians recommended the pharmacy consult, and 95% of participants and 95.8% of clinicians recommended the PT consult.
CONCLUSION


These findings support the feasibility and acceptability of the GAPcare model in the ED. A future larger randomized controlled trial is planned to determine whether GAPcare can reduce recurrent falls and healthcare visits in older adults. J Am Geriatr Soc 68:198-206, 2019.",2020,ED length of stay was not increased in the INT arm: UC 5.25 hours vs INT 5.0 hours (P < .94).,"['median participant age was 81\u2009years old, 67% were female, 94% were white, and 16.3% had cognitive impairment', '110 participants', 'older adults', 'older adults who seek care in the emergency department (ED) after having a fall', 'Adults 65\u2009years old or older (n = 110) who presented to the ED within 7\u2009days of a fall', 'Two urban academic EDs PARTICIPANTS']","['brief medication therapy management session delivered by a pharmacist and a fall risk assessment and plan by a physical therapist (PT', 'usual care (UC) and an intervention (INT', 'GAPcare', 'Geriatric Acute and Post-acute Fall Prevention Intervention (GAPcare', 'new multidisciplinary team fall prevention intervention']","['feasibility and acceptability of the intervention', 'ED length of stay', 'recurrent falls and healthcare visits', 'Median consult time']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C1611232', 'cui_str': 'Drug Therapy Management'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C1532976', 'cui_str': 'Fall risk assessment'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention (procedure)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",110.0,0.0377093,ED length of stay was not increased in the INT arm: UC 5.25 hours vs INT 5.0 hours (P < .94).,"[{'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Goldberg', 'Affiliation': 'Department of Emergency Medicine, The Warren Alpert Medical School of Brown University, Providence, Rhode Island.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Marks', 'Affiliation': ""Department of Emergency Medicine, Brigham and Women's Hospital, Harvard University, Boston, Massachusetts.""}, {'ForeName': 'Aderonke', 'Initials': 'A', 'LastName': 'Ilegbusi', 'Affiliation': 'Department of Emergency Medicine, The Warren Alpert Medical School of Brown University, Providence, Rhode Island.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Resnik', 'Affiliation': 'Department of Health Services, Practice and Policy, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Strauss', 'Affiliation': 'Department of Emergency Medicine, The Warren Alpert Medical School of Brown University, Providence, Rhode Island.'}, {'ForeName': 'Roland C', 'Initials': 'RC', 'LastName': 'Merchant', 'Affiliation': ""Department of Emergency Medicine, Brigham and Women's Hospital, Harvard University, Boston, Massachusetts.""}]",Journal of the American Geriatrics Society,['10.1111/jgs.16210']
528,31167050,Longer-Term Assessment of Azithromycin for Reducing Childhood Mortality in Africa.,"BACKGROUND


The MORDOR I trial (Macrolides Oraux pour Réduire les Décès avec un Oeil sur la Résistance) showed that in Niger, mass administration of azithromycin twice a year for 2 years resulted in 18% lower postneonatal childhood mortality than administration of placebo. Whether this benefit could increase with each administration or wane owing to antibiotic resistance was unknown.
METHODS


In the Niger component of the MORDOR I trial, we randomly assigned 594 communities to four twice-yearly distributions of either azithromycin or placebo to children 1 to 59 months of age. In MORDOR II, all these communities received two additional open-label azithromycin distributions. All-cause mortality was assessed twice yearly by census workers who were unaware of participants' original assignments.
RESULTS


In the MORDOR II trial, the mean (±SD) azithromycin coverage was 91.3±7.2% in the communities that received twice-yearly azithromycin for the first time (i.e., had received placebo for 2 years in MORDOR I) and 92.0±6.6% in communities that received azithromycin for the third year (i.e., had received azithromycin for 2 years in MORDOR I). In MORDOR II, mortality was 24.0 per 1000 person-years (95% confidence interval [CI], 22.1 to 26.3) in communities that had originally received placebo in the first year and 23.3 per 1000 person-years (95% CI, 21.4 to 25.5) in those that had originally received azithromycin in the first year, with no significant difference between groups (P = 0.55). In communities that had originally received placebo, mortality decreased by 13.3% (95% CI, 5.8 to 20.2) when the communities received azithromycin (P = 0.007). In communities that had originally received azithromycin and continued receiving it for an additional year, the difference in mortality between the third year and the first 2 years was not significant (-3.6%; 95% CI, -12.3 to 4.5; P = 0.50).
CONCLUSIONS


We found no evidence that the effect of mass administration of azithromycin on childhood mortality in Niger waned in the third year of treatment. Childhood mortality decreased when communities that had originally received placebo received azithromycin. (Funded by the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT02047981.).",2019,"In communities that had originally received placebo, mortality decreased by 13.3% (95% CI, 5.8 to 20.2) when the communities received azithromycin (P = 0.007).",['Africa'],"['Azithromycin', 'azithromycin or placebo', 'azithromycin', 'placebo']","['Childhood mortality', 'childhood mortality', 'postneonatal childhood mortality', 'mortality', 'Childhood Mortality', 'mean (±SD) azithromycin coverage']","[{'cui': 'C0001737', 'cui_str': 'Africa'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]",,0.337635,"In communities that had originally received placebo, mortality decreased by 13.3% (95% CI, 5.8 to 20.2) when the communities received azithromycin (P = 0.007).","[{'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Arzika', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Ramatou', 'Initials': 'R', 'LastName': 'Maliki', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Nameywa', 'Initials': 'N', 'LastName': 'Boubacar', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Sanoussi', 'Initials': 'S', 'LastName': 'Elh Adamou', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Moussa Ali', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cook', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lebas', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Ray', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Kieran S', 'Initials': 'KS', 'LastName': ""O'Brien"", 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Doan', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'E Kelly', 'Initials': 'EK', 'LastName': 'Callahan', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Emerson', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.'}]",The New England journal of medicine,['10.1056/NEJMoa1817213']
529,31630566,Community-Partnered Evaluation of the Aging Mastery Program in Los Angeles Area Senior Centers.,"Background.  The National Council on Aging's Aging Mastery Program (AMP) aims to help older adults implement health behavior and lifestyle changes to promote healthy aging and social engagement. The purpose of the present community-partnered evaluation was to test the effectiveness of AMP implementation in Los Angeles County to improve participants' quality of life, global physical and mental health, and patient activation.  Method.  A modified randomized wait-list controlled trial design was used to examine experimental, quasi-experimental, and dose-response evidence in five senior centers. Participants completed questionnaires at baseline and after the 10-week intervention, self-reporting their overall quality of life, physical health, mental health, and patient activation.  Results.  Experimental, intention-to-treat analyses found AMP assignment did not affect any measured outcomes ( n  = 71). Quasi-experimental, ""as treated"" analyses ( n  = 106) controlling for study site and sociodemographic characteristics indicated that participants who attended AMP reported more positive changes in global mental health than the control group. Attending AMP was not associated with changes in quality of life, physical health, or patient activation. Dose-response analyses among AMP participants who attended at least one class ( n  = 75) found that attending more classes was not significantly associated with greater improvements in mental health.  Conclusions.  Experimental, intention-to-treat analyses did not support effectiveness of AMP on quality of life, physical or mental health, or patient activation; quasi-experimental analyses found attending AMP was associated with improvements in mental health. Recruitment challenges and participants' nonadherence with condition assignment decreased our ability to detect effects. https://clinicaltrials.gov/ct2/show/NCT03342729?term=Aging+Mastery+Program&rank=1 .",2020,"Experimental, intention-to-treat analyses did not support effectiveness of AMP on quality of life, physical or mental health, or patient activation; quasi-experimental analyses found attending AMP was associated with improvements in mental health.","['five senior centers', 'Los Angeles Area Senior Centers']",['Mastery Program (AMP'],"['quality of life, physical health, or patient activation', 'global mental health', 'self-reporting their overall quality of life, physical health, mental health, and patient activation', 'quality of life, physical or mental health, or patient activation', ""participants' quality of life, global physical and mental health, and patient activation"", 'mental health']","[{'cui': 'C3658240', 'cui_str': 'Centers for the Aged'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0645200', 'cui_str': 'diphosphoribosyl-adenosine monophosphate'}]","[{'cui': 'C0034380'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",5.0,0.0743711,"Experimental, intention-to-treat analyses did not support effectiveness of AMP on quality of life, physical or mental health, or patient activation; quasi-experimental analyses found attending AMP was associated with improvements in mental health.","[{'ForeName': 'Lourdes R', 'Initials': 'LR', 'LastName': 'Guerrero', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Josephine A', 'Initials': 'JA', 'LastName': 'Menkin', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Carmen A', 'Initials': 'CA', 'LastName': 'Carrillo', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Carmen E', 'Initials': 'CE', 'LastName': 'Reyes', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Trejo', 'Affiliation': 'City of Los Angeles Department of Aging, Los Angeles, CA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Banks', 'Affiliation': 'Aging and Community Services, Los Angeles, CA, USA.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Sarkisian', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198119882992']
530,31373430,A comparison of the effectiveness of lateral versus posterior approach to shoulder injection in patients with subacromial impingement syndrome: A pragmatic randomized controlled trial.,"OBJECTIVE


The aim of the study was to determine the effectiveness of the lateral approach to subacromial injection, compared with the posterior approach, for the treatment of subacromial impingement syndrome.
METHOD


A pragmatic randomized controlled trial was carried out in an outpatient community musculoskeletal service. The sample comprised 80 adults, aged 18 years or over, with subacromial impingement syndrome. The intervention group received a single subacromial injection, using a 21-gauge green needle, of 40 mg/ml triamcinolone acetonide (Kenalog) and 4 ml 1% lignocaine using a lateral approach. The control group received identical treatment, with the exception that the injection was given using a posterior approach. The outcome measures were pain measured using 0-10 numerical pain scale and shoulder pain and disability index (SPADI) scores at 8 and 12 weeks' follow-up.
RESULT


A moderate but statistically and clinically significant difference in improvement in daytime pain (mean change in score) occurred in favour of the lateral group (mean = 4.0) compared with the posterior group (mean = 2.0) between weeks 0 and 8 (1.4 points [95% confidence interval 0.3, 2.6; p = 0.018]). However, there were no statistically significant differences between the groups in night-time pain, shoulder function and SPADI scores. There was a statistically and clinically significant difference (p = 0.001) within the groups for all clinical outcomes between weeks 0 and 8, and between weeks 0 and 12.
CONCLUSION


There were no significant differences in the treatments; however, both forms of treatment were associated with a significant improvement in shoulder pain, function and disability.",2019,"However, there were no statistically significant differences between the groups in night-time pain, shoulder function and SPADI scores.","['patients with subacromial impingement syndrome', 'subacromial impingement syndrome', 'outpatient community musculoskeletal service', '80 adults, aged 18 years or over, with subacromial impingement syndrome']","['lateral versus posterior approach to shoulder injection', 'single subacromial injection, using a 21-gauge green needle, of 40 mg/ml triamcinolone acetonide (Kenalog) and 4 ml 1% lignocaine']","['pain measured using 0-10 numerical pain scale and shoulder pain and disability index (SPADI) scores', 'daytime pain', 'night-time pain, shoulder function and SPADI scores', 'shoulder pain, function and disability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4255192', 'cui_str': 'Coracohumeral Impingement'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0205512', 'cui_str': 'Posterior approach (qualifier value)'}, {'cui': 'C0856432', 'cui_str': 'Shoulder injection'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0456564', 'cui_str': 'Gauges (qualifier value)'}, {'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone Acetonide'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0031843', 'cui_str': 'function'}]",80.0,0.208425,"However, there were no statistically significant differences between the groups in night-time pain, shoulder function and SPADI scores.","[{'ForeName': 'Collins', 'Initials': 'C', 'LastName': 'Ogbeivor', 'Affiliation': 'Rehabilitation Department, John Hopkins Healthcare Aramco, Dhahran, Kingdom of Saudi Arabia.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Bandaru', 'Affiliation': 'Department of Physiotherapy, East Sussex Hospital Trust, Hastings, UK.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Milton', 'Affiliation': 'Department of Physiotherapy, East Sussex Hospital Trust, Hastings, UK.'}]",Musculoskeletal care,['10.1002/msc.1416']
531,31209960,When words hurt: Verbal suggestion prevails over conditioning in inducing the motor nocebo effect.,"Perception and behavior are strongly influenced by the verbal information conveyed by other individuals (e.g., verbal suggestion) and by learning (e.g., conditioning). This influence is well represented by the placebo and nocebo effects, in which positive verbal suggestion associated with positive conditioning induces beneficial outcomes (placebo effect), while the opposite is true for the negative counterpart (nocebo effect). It is still unclear whether verbal suggestion and conditioning exert distinctive roles in influencing perception, behavior and motor system activity when they occur in opposite directions. To this purpose, fifty-three healthy volunteers were assigned to four groups characterized by either congruent or incongruent verbal suggestion and conditioning. Participants were asked to perform a force motor task by pressing a piston as strongly as possible. Transcranial magnetic stimulation over the primary motor cortex was used to record motor evoked potentials (MEP) and cortical silent period (CSP) from the muscle involved in the task. We found that negative verbal suggestion counteracted positive conditioning and induced sense of weakness, effort, and force decrements. MEP amplitude was stable, whereas the CSP duration shortened in all the groups throughout the procedure, indicating the involvement of cortical inhibitory circuits, independently of the type of verbal suggestion or conditioning. Our findings highlight a prevalent role of verbal suggestion over conditioning in determining a worsening (nocebo effect) but not an improvement (placebo effect) of motor performance. These results suggest that words associated with treatments should be chosen carefully to avoid negative outcomes, especially in sports and clinical settings.",2019,"MEP amplitude was stable, whereas the CSP duration shortened in all the groups throughout the procedure, indicating the involvement of cortical inhibitory circuits, independently of the type of verbal suggestion or conditioning.",['fifty-three healthy volunteers'],"['Transcranial magnetic stimulation', 'congruent or incongruent verbal suggestion and conditioning', 'placebo']","['CSP duration', 'motor evoked potentials (MEP) and cortical silent period (CSP', 'MEP amplitude']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0439853', 'cui_str': 'Congruent (qualifier value)'}, {'cui': 'C1321310', 'cui_str': 'Incongruous'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C0443304', 'cui_str': 'Silent (qualifier value)'}]",53.0,0.0360446,"MEP amplitude was stable, whereas the CSP duration shortened in all the groups throughout the procedure, indicating the involvement of cortical inhibitory circuits, independently of the type of verbal suggestion or conditioning.","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Corsi', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Emadi Andani', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Sometti', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Tinazzi', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Mirta', 'Initials': 'M', 'LastName': 'Fiorio', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}]",The European journal of neuroscience,['10.1111/ejn.14489']
532,31763749,Parents in Control: Parental perceptions of problem behaviors before and after attending an ADHD-specific parent-training program.,"PROBLEM


There is scant evidence to support the efficacy of attention deficit hyperactivity disorder (ADHD)-specific parent-training programs in the treatment of preadolescent children with ADHD. This study explores the effectiveness of the Parents in Control (PINC) parent-training program, designed specifically for children with ADHD.
METHODS


In this pragmatic uncontrolled pre-poststudy parents of preadolescent children with a diagnosis of ADHD were invited to attend the 6-week PINC course. Fifty-seven parent-report pre/postprogram questionnaires were completed.
FINDINGS


Parental ratings of the intensity and frequency of problem behaviors after completing PINC showed a significant reduction (p < .001) with a moderate effect size (0.6-0.7).
CONCLUSIONS


Our findings demonstrate the efficacy of PINC in reducing the parental perception of problem behaviors and support a need for further rigorous randomised controlled trial (RCT) evaluation of this ADHD-specific intervention.",2020,"FINDINGS


Parental ratings of the intensity and frequency of problem behaviors after completing PINC showed a significant reduction (p < .001) with a moderate effect size (0.6-0.7).
","['preadolescent children with a diagnosis of ADHD', 'children with ADHD', 'Fifty-seven parent-report pre/postprogram questionnaires were completed', 'preadolescent children with ADHD']","['PINC', 'Parents in Control (PINC) parent-training program']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],,0.0629253,"FINDINGS


Parental ratings of the intensity and frequency of problem behaviors after completing PINC showed a significant reduction (p < .001) with a moderate effect size (0.6-0.7).
","[{'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Foubister', 'Affiliation': ""CAMHS, Royal Aberdeen Children's Hospital, Aberdeen, United Kingdom.""}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Rennie', 'Affiliation': ""CAMHS, Royal Aberdeen Children's Hospital, Aberdeen, United Kingdom.""}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': ""CAMHS, Royal Aberdeen Children's Hospital, Aberdeen, United Kingdom.""}]","Journal of child and adolescent psychiatric nursing : official publication of the Association of Child and Adolescent Psychiatric Nurses, Inc",['10.1111/jcap.12261']
533,31897708,Evaluation of efficacy of non-thermal atmospheric pressure plasma in treatment of periodontitis: a randomized controlled clinical trial.,"OBJECTIVES


In this clinical study, we aim to evaluate the effectiveness of non-thermal atmospheric pressure plasma (NAPP), which is a novel procedure used in periodontal pocket decontamination adjunctive to non-surgical periodontal treatment (NSPT).
METHODS


The study included 25 systemically healthy periodontitis patients. In the split-mouth design, NAPP application into the pockets, in addition to NSPT, was performed. Clinical periodontal data, gingival crevicular fluid, and subgingival plaque samples of patients were taken before and during the first and third months of treatment. Biochemical assays were conducted using enzyme-linked immunosorbent assay. Analysis of bacteria was performed with polymerase chain reaction method.
RESULTS


There was more clinical attachment level (CAL) gain in the 3rd month in the test group (deep pockets: 3.90 mm, pockets ≥ 5 mm: 2.72 mm) compared to the control group (deep pockets: 3.40 mm, pockets ≥ 5 mm: 2.58 mm) (p < 0.05), but no significant difference between groups in CAL. Clinical periodontal parameters improved in both study groups (p < 0.05). However, the gingival index (GI) and the bleeding on probing (BOP) rate decreased more in the test group (GI: 0.55, BOP: 9.48%, and GI: 0.38, BOP: 8.46% in the 1st and 3rd months, respectively) compared to the control group (GI: 0.68, BOP: 13.43%, and GI: 0.52, BOP: 14.58%) (p < 0.05). In addition, there was no significant difference in probing depth and biochemical markers between groups (p > 0.05). It was observed that NAPP reduced the number of bacteria more than the control group in the 1st and 3rd months.
CONCLUSIONS


It was seen that the single-time NAPP application concurrent with NSPT provided additional CAL gain, elimination of putative periodontopathogens and reduced their recolonization. Longitudinal studies with larger population and longer time are required.
CLINICAL RELEVANCE


NSPT is an effective method for the treatment of periodontitis but bacteria recolonization that causes recurrence of the periodontal disease occurs within a short period. NAPP can reduce the recurrence of periodontal disease by providing better bacterial elimination and should, therefore, be used in maintenance of periodontitis.",2020,"In addition, there was no significant difference in probing depth and biochemical markers between groups (p > 0.05).","['25 systemically healthy periodontitis patients', 'periodontitis']","['NAPP', 'non-thermal atmospheric pressure plasma (NAPP', 'non-thermal atmospheric pressure plasma']","['number of bacteria', 'clinical attachment level (CAL) gain', 'Clinical periodontal parameters', 'probing depth and biochemical markers', 'gingival index (GI) and the bleeding on probing (BOP) rate', 'Clinical periodontal data, gingival crevicular fluid, and subgingival plaque samples']","[{'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2936478', 'cui_str': 'Cold Plasma'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Marker'}, {'cui': 'C0017569', 'cui_str': 'Gingival Index'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0399451', 'cui_str': 'Subgingival plaque (disorder)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]",,0.0446573,"In addition, there was no significant difference in probing depth and biochemical markers between groups (p > 0.05).","[{'ForeName': 'Diğdem', 'Initials': 'D', 'LastName': 'Küçük', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Savran', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Utku Kürşat', 'Initials': 'UK', 'LastName': 'Ercan', 'Affiliation': 'Faculty of Engineering and Architecture, Department of Biomedical Engineering, Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Ziyşan Buse', 'Initials': 'ZB', 'LastName': 'Yarali', 'Affiliation': 'Department of Biomedical Engineering, Tissue Engineering and Regenerative Medicine Laboratory, Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Ozan', 'Initials': 'O', 'LastName': 'Karaman', 'Affiliation': 'Faculty of Engineering and Architecture, Department of Biomedical Engineering, Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Alpdoğan', 'Initials': 'A', 'LastName': 'Kantarci', 'Affiliation': 'The Forsyth Institute, Department of Applied Oral Sciences, Center for Periodontology, Cambridge, USA.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Sağlam', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Serhat', 'Initials': 'S', 'LastName': 'Köseoğlu', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Katip Celebi University, Izmir, Turkey. serhatkoseoglu@gmail.com.'}]",Clinical oral investigations,['10.1007/s00784-019-03187-2']
534,31906814,Functional Resistance Training Superiority Over Conventional Training in Metabolic Syndrome: A Randomized Clinical Trial.,"Metabolic syndrome (MetS) is a growing epidemic related with higher values of blood pressure (BP) and autonomic dysfunction. Scientific evidence has been indicating that functional resistance training (FRT) is superior over conventional (CRT) for muscle fatigue and pain, yet its effects on autonomic modulation (AM), BP and heart rate in MetS are unclear. We theorized that FRT can be superior to CRT in MetS patients because of larger muscle activation. This study compares FRT and CRT on AM, blood pressure, heart rate and muscle strength. Thirty-eight sex and age matched individuals (40 to 60 years) were randomized for FRT or CRT, with training intensity varying gradually from 30%-100% of one maximal repetition test (1MR), 3 times/week for 30 sessions. All outcomes were evaluated at baseline and post training. AM was assessed by heart rate variability (mean RR, RMSSD, SDNN, LF, HF, TINN, RRtri, SD1 and SD2). BP (mmHg) was obtained by cuff measures. Muscle strength was assessed by 1MR. An increase in cardiac parasympathetic activity was observed in individuals allocated to FRT in comparison to CRT group (RMSSD ∆40%; SD1 ∆39%; and HF  ms   2  ∆80%). Moreover, just FRT was capable of reducing BP post intervention (SBP from 129.21 ± 19.02 to 118.94 ± 14.14 mmHg,  p  < .009,/d/ = 0.49; DBP from 85.26 ± 11.48 to 77.76 ± 8.93 mmHg,  p  < .01,/d/ = 0.51). Both groups had a similar increase in muscle strength and no changes between HR. Progressive FRT was more beneficial to CRT regarding AM, increasing vagal activity, and reducing blood pressure in MetS individuals.",2020,An increase in cardiac parasympathetic activity was observed in individuals allocated to FRT in comparison to CRT group (RMSSD ∆40%; SD1 ∆39%; and HF  ms 2  ∆80%).,"['Metabolic Syndrome', 'Thirty-eight sex and age matched individuals (40 to 60\xa0years']","['FRT or CRT', 'FRT', 'functional resistance training (FRT) is superior over conventional (CRT', 'Functional Resistance Training Superiority over Conventional Training']","['AM, blood pressure, heart rate and muscle strength', 'cardiac parasympathetic activity', 'Muscle strength', 'muscle strength', 'vagal activity', 'blood pressure (BP) and autonomic dysfunction', 'autonomic modulation (AM), BP and heart rate', 'blood pressure', 'BP (mmHg', 'heart rate variability (mean RR, RMSSD, SDNN, LF, HF, TINN, RRtri, SD1 and SD2']","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1145628', 'cui_str': 'Central Autonomic Nervous System Diseases'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1861380', 'cui_str': 'Syndactyly, Type I'}]",38.0,0.0184077,An increase in cardiac parasympathetic activity was observed in individuals allocated to FRT in comparison to CRT group (RMSSD ∆40%; SD1 ∆39%; and HF  ms 2  ∆80%).,"[{'ForeName': 'Natália', 'Initials': 'N', 'LastName': 'Turri-Silva', 'Affiliation': 'University of Brasilia.'}, {'ForeName': 'Ana Laura', 'Initials': 'AL', 'LastName': 'Ricci-Vitor', 'Affiliation': 'São Paulo State University (UNESP).'}, {'ForeName': 'Gerson', 'Initials': 'G', 'LastName': 'Cipriano', 'Affiliation': 'University of Brasilia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Garner', 'Affiliation': 'Oxford Brookes University.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Netto', 'Affiliation': 'São Paulo State University (UNESP).'}, {'ForeName': 'Thaís', 'Initials': 'T', 'LastName': 'Giacon', 'Affiliation': 'São Paulo State University (UNESP).'}, {'ForeName': 'Diego Giulliano', 'Initials': 'DG', 'LastName': 'Destro Christofaro', 'Affiliation': 'São Paulo State University (UNESP).'}, {'ForeName': 'Luiz Carlos', 'Initials': 'LC', 'LastName': 'Marques Vanderlei', 'Affiliation': 'Oxford Brookes University.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2019.1679333']
535,31632709,Efficacy of water spray for evaporative cooling in athletes with spinal cord injury.,"Study design


Interventional crossover study.
Objective


Spinal cord injury (SCI) disrupts afferent input to the hypothalamus and impairs efferent vaso- and sudomotor output, especially in lesions above the sympathetic chain (T1-L2). In consequence, persons with SCI under heat stress experience impairment in the ability to dissipate heat proportional to the lesion level. Thermoregulatory dysfunction places an individual at high risk of hyperthermia, which can be life threatening, especially for athletes with SCI during exercise. Current evidence on therapeutic cooling techniques in athletes with SCI is limited, but basic physiologic and research data suggest water spray (WS) might be efficacious, particularly in athletes with tetraplegia (TP), who are most impaired in thermoregulation. The aim of this study was to evaluate the effect of WS on core temperature (Tc) during exercise in athletes with SCI.
Setting


Texas, USA.
Methods


Eleven individuals with SCI: seven with TP, four with paraplegia (PP); and sixteen able-bodied (AB) controls underwent a wheelchair intermittent sprint exercise for 90 min under two conditions: (1) WS application every 15 min and (2) control (C), without WS. Tc was measured every 15 min and was analyzed for the effect of group (TP, PP, and AB) and time. Change in Tc (ΔTc) was also compared between groups.
Results


ΔTc was significantly higher in TP vs. PP ( p  < 0.0001) and TP vs. AB ( p  < 0.0001) groups under C treatment. WS significantly attenuated ΔTc in TP ( p  = 0.001), but did not change ΔTc in PP or AB.
Conclusion


WS effectively attenuated Tc elevation during exercise in athletes with TP.
Sponsorship


Texas chapter of the Paralyzed Veterans of America.",2019,"WS significantly attenuated ΔTc in TP ( p  = 0.001), but did not change ΔTc in PP or AB.
Conclusion


WS effectively attenuated Tc elevation during exercise in athletes with TP.
","['athletes with spinal cord injury', 'athletes with tetraplegia (TP', 'Sponsorship\n\n\nTexas chapter of the Paralyzed Veterans of America', 'Eleven individuals with SCI: seven with TP, four with paraplegia (PP); and sixteen able-bodied (AB) controls underwent a', 'athletes with SCI']","['water spray', 'wheelchair intermittent sprint exercise for 90\u2009min under two conditions: (1) WS application every 15\u2009min and (2) control (C), without WS']","['Change in Tc (ΔTc', 'Tc elevation', 'core temperature (Tc', 'TP vs. PP']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0034372', 'cui_str': 'Tetraplegia'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0002454', 'cui_str': 'Americas'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030486', 'cui_str': 'Paralysis, Legs'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0043143', 'cui_str': 'Wheel Chairs'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]",11.0,0.0318801,"WS significantly attenuated ΔTc in TP ( p  = 0.001), but did not change ΔTc in PP or AB.
Conclusion


WS effectively attenuated Tc elevation during exercise in athletes with TP.
","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Trbovich', 'Affiliation': '1Department of Rehabilitation Medicine, University of Texas Health Science Center at San Antonio, San Antonio, TX USA.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Koek', 'Affiliation': '2Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, TX USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ortega', 'Affiliation': '3School of Health Professions, Physical Therapy Department, University of Texas Health Science Center at San Antonio, San Antonio, TX USA.'}]",Spinal cord series and cases,['10.1038/s41394-019-0194-8']
536,31904175,"The effect of oral hydrolyzed eggshell membrane on the appearance of hair, skin, and nails in healthy middle-aged adults: A randomized double-blind placebo-controlled clinical trial.","BACKGROUND


Many over the counter and consumer packaged goods are promoted to enhance the appearance of hair, skin, and nails for the consumer. Nutrition is a major factor in affecting the health and appearance of hair, skin, and nails. In addition to how one eats, dietary supplementation may play a role in overall health and in the physical appearance.
AIMS


It was the aim of this study to objectively and subjectively evaluate the impacts of a nutritional intervention as compared to placebo on the appearances of hair, skin, and nails in healthy middle-aged adults.
METHODS


Randomized, double-blind placebo-controlled study with 88 subjects randomized evenly to Study Product (BiovaBio™ 450 mg/d, n = 44) or Placebo (n = 44) for 12-weeks. Outcome tests included TrichoScan HD (hair), Canfield Visia ®  -CR (skin), modified FACE-Q (skin), and anchored Likert Scales (nails).
RESULTS


Oral hydrolyzed eggshell membrane ingestion was associated with a significant improvement in facial skin appearance in crow's feet in 4 weeks and skin tone in 8 weeks, with significant impact on hair thickness, reduction in hair breakage and improvement in hair growth at 4, 8, and 12 weeks. There were no observed subjective improvements for nails (appearance, strength or growth).
CONCLUSIONS


Oral supplementation of 450 mg/d hydrolyzed eggshell membrane for 12 weeks is associated with improvement in the appearance of facial skin and hair.",2020,"RESULTS


Oral hydrolyzed eggshell membrane ingestion was associated with a significant improvement in facial skin appearance in crow's feet in 4 weeks and skin tone in 8 weeks, with significant impact on hair thickness, reduction in hair breakage and improvement in hair growth at 4, 8, and 12 weeks.","['88 subjects randomized evenly to', 'healthy middle-aged adults']","['Study Product (BiovaBio™ 450\xa0mg', 'Placebo', 'nutritional intervention', 'placebo', 'oral hydrolyzed eggshell membrane']","['hair thickness, reduction in hair breakage and improvement in hair growth', 'appearances of hair, skin, and nails', 'facial skin appearance', 'appearance of hair, skin, and nails', 'subjective improvements for nails (appearance, strength or growth', 'TrichoScan HD (hair), Canfield Visia ®  -CR (skin), modified FACE-Q (skin), and anchored Likert Scales (nails', 'appearance of facial skin and hair']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4521537', 'cui_str': 'Eggshell'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}]","[{'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1112754', 'cui_str': 'Hair breakage'}, {'cui': 'C0232407', 'cui_str': 'Hair growth, function (observable entity)'}, {'cui': 'C1286247', 'cui_str': 'Appearance of hair'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}]",,0.281269,"RESULTS


Oral hydrolyzed eggshell membrane ingestion was associated with a significant improvement in facial skin appearance in crow's feet in 4 weeks and skin tone in 8 weeks, with significant impact on hair thickness, reduction in hair breakage and improvement in hair growth at 4, 8, and 12 weeks.","[{'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Kalman', 'Affiliation': 'Health Professions Division, Department of Health and Human Performance, College of Health Care Sciences, Nova Southeastern University, Davie, FL, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Hewlings', 'Affiliation': 'Department of Human Environmental Studies, Central Michigan University, Mount Pleasant, MI, USA.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13275']
537,31074089,"The effects of nanocurcumin on Treg cell responses and treatment of ankylosing spondylitis patients: A randomized, double-blind, placebo-controlled clinical trial.","AIM


Ankylosing spondylitis (AS) is an inflammatory rheumatic disease with increased bone mass in the main sites of inflammation. Regulatory T (Treg) cells have been reported to involve in pathology of AS. This study designed at investigating the effects of nanocurcumin on Treg cell responses in peripheral blood (PB) of AS patients.
METHODS


Test group including 12 AS patients received nanocurcumin daily for 4 months and control group including 12 patients received placebo. The frequency of Treg was measured by flow cytometry. The expression levels of FoxP3 and several associated microRNAs (miRNAs; miR-27, miR-17, and miR-146a) and cytokines including Interleukin-10 (IL-10), TGF-β, and IL-6 were assessed by real-time polymerase chain reaction. Furthermore, enzyme-linked immunosorbent assay was done to determine the secretion levels of cytokines.
RESULTS


After treatment with nanocurcumin the frequency of Treg cells in AS patients increased significantly. The RT-PCR data indicated that the expression of miR-17 and miR-27 were significantly decreased following nanocurcumin treatment while miR-146a and FoxP3 were significantly increased. Moreover, nanocurcumin-treated group had high levels of IL-10 and TGF-β and low levels of IL-6 production than control group.
CONCLUSION


The findings suggested that dysregulation of Treg cells in PB influences the AS development and nanocurcumin therapy could regulate the Treg cells, and so could be useful in the treatment of AS and may be other autoimmune diseases. This study is registered with IRCT.ir, number IRCT2017052927520N7.",2020,The RT-PCR data indicated that the expression of miR-17 and miR-27 were significantly decreased following nanocurcumin treatment while miR-146a and FoxP3 were significantly increased.,"['peripheral blood (PB) of AS patients', 'ankylosing spondylitis patients']","['nanocurcumin daily', 'nanocurcumin', 'placebo']","['frequency of Treg', 'frequency of Treg cells', 'levels of IL-10 and TGF-β and low levels of IL-6 production', 'expression of miR-17 and miR-27', 'expression levels of FoxP3 and several associated microRNAs (miRNAs; miR-27, miR-17, and miR-146a) and cytokines including Interleukin-10 (IL-10), TGF-β, and IL-6']","[{'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038013', 'cui_str': 'Spondylarthritis Ankylopoietica'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0039198', 'cui_str': 'T-Cells, Regulatory'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0033268'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C1101610', 'cui_str': 'miRNA'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",,0.20871,The RT-PCR data indicated that the expression of miR-17 and miR-27 were significantly decreased following nanocurcumin treatment while miR-146a and FoxP3 were significantly increased.,"[{'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ahmadi', 'Affiliation': 'Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mehrzad', 'Initials': 'M', 'LastName': 'Hajialilo', 'Affiliation': 'Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Sanam', 'Initials': 'S', 'LastName': 'Dolati', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Eghbal-Fard', 'Affiliation': 'Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hanieh', 'Initials': 'H', 'LastName': 'Heydarlou', 'Affiliation': 'Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Ghaebi', 'Affiliation': 'Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Arezou', 'Initials': 'A', 'LastName': 'Ghassembaglou', 'Affiliation': 'Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'Aghebati-Maleki', 'Affiliation': 'Immunology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Samadi Kafil', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Kamrani', 'Affiliation': 'Department of Immunology, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Badrossadat', 'Initials': 'B', 'LastName': 'Rahnama', 'Affiliation': 'Immunology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Rikhtegar', 'Affiliation': 'Aging Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yousefi', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Journal of cellular biochemistry,['10.1002/jcb.28901']
538,30957594,Community-level Association between Clinical Trachoma and Ocular Chlamydia Infection after MASS Azithromycin Distribution in a Mesoendemic Region of Niger.,"Purpose : The clinical sign trachomatous inflammation - follicular (TF) is used to monitor indication for and response to mass azithromycin distribution in trachoma-endemic communities. Here, we assess the relationship between TF, trachomatous inflammation - intense (TI), and infection with ocular  Chlamydia trachomatis  over time during annual mass azithromycin distribution.  Methods : We used data from a cluster-randomized trial of mass azithromycin distribution for trachoma control in a mesoendemic region of Niger. This study includes 24 communities that received 3 years of annual mass azithromycin distribution. TF, TI, and ocular chlamydia infection were monitored among children aged 0-5 years. We assessed the correlation between the prevalence of ocular chlamydia infection and 1) TF and 2) TI prevalence over time.  Results : At baseline, ocular chlamydia prevalence was 21.2% (95% CI 14.3-28.1%), TF prevalence was 27.7% (95% CI 21.2-34.2%), and TI prevalence was 8.3% (95% CI 5.2-11.5%). The prevalence of all three measures decreased significantly over time (P < 0.001). At baseline, ocular chlamydia infection prevalence was strongly correlated with both TF (rho = 0.78, P < 0.0001) and TI (rho = 0.76, P < 0.0001). The correlation between ocular chlamydia infection and both TF and TI was weak at months 12 and 24. At 36 months, when TF prevalence had dropped below 10%, ocular chlamydia infection and TF were moderately correlated (rho = 0.70,  P = 0.0002).  Conclusions :  Both TF and TI are good indicators of infection prevalence prior to mass azithromycin distribution. However, this relationship may be affected by repeated rounds of mass azithromycin distribution.",2019,"At baseline, ocular chlamydia prevalence was 21.2% (95% CI 14.3-28.1%), TF prevalence was 27.7% (95% CI 21.2-34.2%), and TI prevalence was 8.3% (95% CI 5.2-11.5%).","['children aged 0-5 years', 'trachoma-endemic communities', 'trachoma control in a mesoendemic region of Niger', '24 communities that received 3 years of annual mass azithromycin distribution']",['azithromycin'],"['TF prevalence', 'TI prevalence', 'ocular chlamydia infection prevalence', 'ocular chlamydia infection and 1) TF and 2) TI prevalence over time', 'ocular chlamydia infection and both TF and TI', 'ocular chlamydia infection and TF', 'TF, TI, and ocular chlamydia infection', 'relationship between TF, trachomatous inflammation - intense (TI), and infection with ocular Chlamydia trachomatis', 'ocular chlamydia prevalence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0040592', 'cui_str': 'Egyptian Ophthalmia'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0028074', 'cui_str': 'Republic of Niger'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0008149', 'cui_str': 'Chlamydia Infections'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0008151', 'cui_str': 'Chlamydia trachomatis'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}]",,0.0494055,"At baseline, ocular chlamydia prevalence was 21.2% (95% CI 14.3-28.1%), TF prevalence was 27.7% (95% CI 21.2-34.2%), and TI prevalence was 8.3% (95% CI 5.2-11.5%).","[{'ForeName': 'Abdou', 'Initials': 'A', 'LastName': 'Amza', 'Affiliation': 'a Programme FSS/Université Abdou Moumouni de Niamey, Programme Nationale des Soins Oculaire , Niamey , Niger.'}, {'ForeName': 'Boubacar', 'Initials': 'B', 'LastName': 'Kadri', 'Affiliation': 'a Programme FSS/Université Abdou Moumouni de Niamey, Programme Nationale des Soins Oculaire , Niamey , Niger.'}, {'ForeName': 'Beido', 'Initials': 'B', 'LastName': 'Nassirou', 'Affiliation': 'a Programme FSS/Université Abdou Moumouni de Niamey, Programme Nationale des Soins Oculaire , Niamey , Niger.'}, {'ForeName': 'Sun Y', 'Initials': 'SY', 'LastName': 'Cotter', 'Affiliation': 'b Francis I. Proctor Foundation , University of California , San Francisco , USA.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Stoller', 'Affiliation': 'b Francis I. Proctor Foundation , University of California , San Francisco , USA.'}, {'ForeName': 'Sheila K', 'Initials': 'SK', 'LastName': 'West', 'Affiliation': 'c Dana Center for Preventive Ophthalmology, Wilmer Eye Institute, Johns Hopkins University , Baltimore , Maryland , USA.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'd Clinical Research Unit, Department of Infectious and Tropical Diseases , London School of Hygiene and Tropical Medicine , London , United Kingdom.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'b Francis I. Proctor Foundation , University of California , San Francisco , USA.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'b Francis I. Proctor Foundation , University of California , San Francisco , USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'b Francis I. Proctor Foundation , University of California , San Francisco , USA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'b Francis I. Proctor Foundation , University of California , San Francisco , USA.'}]",Ophthalmic epidemiology,['10.1080/09286586.2019.1597129']
539,31826896,"Healthy Dads, Healthy Kids UK, a weight management programme for fathers: feasibility RCT.","OBJECTIVE


To assess (1) the feasibility of delivering a culturally adapted weight management programme, Healthy Dads, Healthy Kids United Kingdom (HDHK-UK), for fathers with overweight or obesity and their primary school-aged children, and (2) the feasibility of conducting a definitive randomised controlled trial (RCT).
DESIGN


A two-arm, randomised feasibility trial with a mixed-methods process evaluation.
SETTING


Socioeconomically disadvantaged, ethnically diverse localities in West Midlands, UK.
PARTICIPANTS


Fathers with overweight or obesity and their children aged 4-11 years.
INTERVENTION


Participants were randomised in a 1:2 ratio to control (family voucher for a leisure centre) or intervention comprising 9 weekly healthy lifestyle group sessions.
OUTCOMES


Feasibility of the intervention and RCT was assessed according to prespecified progression criteria: study recruitment, consent and follow-up, ability to deliver intervention, intervention fidelity, adherence and acceptability, weight loss, using questionnaires and measurements at baseline, 3 and 6 months, and through qualitative interviews.
RESULTS


The study recruited 43 men, 48% of the target sample size; the mean body mass index was 30.2 kg/m 2  (SD 5.1); 61% were from a minority ethnic group; and 54% were from communities in the most disadvantaged quintile for socioeconomic deprivation. Recruitment was challenging. Retention at follow-up of 3 and 6 months was 63%. Identifying delivery sites and appropriately skilled and trained programme facilitators proved difficult. Four programmes were delivered in leisure centres and community venues. Of the 29 intervention participants, 20 (69%) attended the intervention at least once, of whom 75% attended ≥5 sessions. Sessions were delivered with high fidelity. Participants rated sessions as 'good/very good' and reported lifestyle behavioural change. Weight loss at 6 months in the intervention group (n=17) was 2.9 kg (95% CI -5.1 to -0.6).
CONCLUSIONS


The intervention was well received, but there were significant challenges in recruitment, programme delivery and follow-up. The HDHK-UK study was not considered feasible for progression to a full RCT based on prespecified stop-go criteria.
TRIAL REGISTRATION NUMBER


ISRCTN16724454.",2019,"Weight loss at 6 months in the intervention group (n=17) was 2.9 kg (95% CI -5.1 to -0.6).
","['Socioeconomically disadvantaged, ethnically diverse localities in West Midlands, UK', '43 men, 48% of the target sample size; the mean body mass index was 30.2\u2009kg/m 2  (SD 5.1); 61% were from a minority ethnic group; and 54% were from communities in the most disadvantaged quintile for socioeconomic deprivation', 'Fathers with overweight or obesity and their children aged 4-11\u2009years', 'Healthy Dads, Healthy Kids UK, a weight management programme for fathers', 'fathers with overweight or obesity and their primary school-aged children, and (2']","['control (family voucher for a leisure centre) or intervention comprising 9\u2009weekly healthy lifestyle group sessions', 'culturally adapted weight management programme, Healthy Dads, Healthy Kids United Kingdom (HDHK-UK']","['lifestyle behavioural change', 'Weight loss', 'prespecified progression criteria: study recruitment, consent and follow-up, ability to deliver intervention, intervention fidelity, adherence and acceptability, weight loss, using questionnaires and measurements at baseline, 3 and 6\u2009months, and through qualitative interviews']","[{'cui': 'C0454882', 'cui_str': 'West Midlands (geographic location)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015031', 'cui_str': 'Ethnicity'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0015671', 'cui_str': 'Fathers'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0051767', 'cui_str': 'DASD'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0557790', 'cui_str': 'Leisure center (environment)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0051767', 'cui_str': 'DASD'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]",43.0,0.0832928,"Weight loss at 6 months in the intervention group (n=17) was 2.9 kg (95% CI -5.1 to -0.6).
","[{'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Griffin', 'Affiliation': 'Department of Health, University of Bath, Bath, Somerset, UK.'}, {'ForeName': 'Yongzhong', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Birmingham Clinical Trials Unit (BCTU), University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Manbinder', 'Initials': 'M', 'LastName': 'Sidhu', 'Affiliation': 'Health Services Management Centre, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Peymane', 'Initials': 'P', 'LastName': 'Adab', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Burgess', 'Affiliation': 'Fatherhood Institute, Marlborough, Wiltshire, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Collins', 'Affiliation': 'School of Health Sciences, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Daley', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Entwistle', 'Affiliation': 'Public member, Leamington Spa, Warwickshire, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Frew', 'Affiliation': 'Health Economics Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Pollyanna', 'Initials': 'P', 'LastName': 'Hardy', 'Affiliation': 'Birmingham Clinical Trials Unit (BCTU), University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Kiya', 'Initials': 'K', 'LastName': 'Hurley', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Jones', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'McGee', 'Affiliation': 'Birmingham Community Healthcare NHS Trust, Aston, Birmingham, UK.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Pallan', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Myles', 'Initials': 'M', 'LastName': 'Young', 'Affiliation': 'School of Education, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Morgan', 'Affiliation': 'School of Education, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jolly', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK c.b.jolly@bham.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-033534']
540,30374832,"Treatment of intrabony defects with modified perforated membranes in aggressive periodontitis: subtraction radiography outcomes, prognostic variables, and patient morbidity.","OBJECTIVES


The main objectives of this study were (1) to evaluate bone/graft density alterations by digital subtraction radiography; (2) to determine factors associated with favorable clinical and radiographic outcomes, and (3) to report on patient morbidity after guided tissue regeneration (GTR) in aggressive periodontitis (AgP) patients.
MATERIALS AND METHODS


Adapting a split-mouth design, 30 comparative intrabony defects in 15 patients were randomly treated with xenogenic graft plus modified perforated membranes (MPM, tests) or xenogenic graft plus standard collagen membranes (CM, controls). The time period of observation was 12 months.
RESULTS


There were significant improvements in clinical and radiographic parameters within each group, without intergroup differences. However, higher PPD reduction for three-wall defects was noted in MPM sites (5.22 versus 3.62 mm; p = 0.033). Moreover, a significant gain in bone/graft density of 4.9% from 6 to 12 months post-operatively was observed in test sites. Multivariate analysis demonstrated that morphology of intrabony defects was a predictor of CAL gain (p = 0.06), while independent prognostic variables effecting changes in bone/graft density were radiographic defect depth (p = 0.025) and radiographic angle (p = 0.033). The majority of patients reported some discomfort, pain, and edema with mild intensity without any significant differences between treatment modalities.
CONCLUSIONS


This study demonstrated enhanced bone/graft density gain after GTR with MPM, which may indicate greater area of new bone formation. Independent variables effecting treatment outcomes were intrabony defect morphology, radiographic defect depth, and radiographic angle.
CLINICAL RELEVANCE


This study supports the regenerative treatment of intrabony defects in AgP patients and identifies some variables with prognostic value.",2019,"Multivariate analysis demonstrated that morphology of intrabony defects was a predictor of CAL gain (p = 0.06), while independent prognostic variables effecting changes in bone/graft density were radiographic defect depth (p = 0.025) and radiographic angle (p = 0.033).","['aggressive periodontitis (AgP) patients', 'aggressive periodontitis', 'Adapting a split-mouth design, 30 comparative intrabony defects in 15 patients']","['digital subtraction radiography', 'xenogenic graft plus modified perforated membranes (MPM, tests) or xenogenic graft plus standard collagen membranes (CM, controls', 'guided tissue regeneration (GTR']","['bone/graft density were radiographic defect depth', 'discomfort, pain, and edema with mild intensity', 'CAL gain', 'radiographic angle', 'higher PPD reduction', 'intrabony defect morphology, radiographic defect depth, and radiographic angle', 'bone/graft density', 'MPM sites', 'clinical and radiographic parameters']","[{'cui': 'C0031106', 'cui_str': 'Periodontitis, Prepubertal'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C1742123', 'cui_str': '(11C)MPM'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0085147', 'cui_str': 'Guided Tissue Regeneration'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C1742123', 'cui_str': '(11C)MPM'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",15.0,0.16003,"Multivariate analysis demonstrated that morphology of intrabony defects was a predictor of CAL gain (p = 0.06), while independent prognostic variables effecting changes in bone/graft density were radiographic defect depth (p = 0.025) and radiographic angle (p = 0.033).","[{'ForeName': 'Bartłomiej', 'Initials': 'B', 'LastName': 'Górski', 'Affiliation': 'Department of Periodontology and Oral Mucosa Diseases, Medical Unversity of Warsaw, Miodowa St 18, 00-246, Warsaw, Poland. bartek_g3@tlen.pl.'}, {'ForeName': 'Stanisław', 'Initials': 'S', 'LastName': 'Jalowski', 'Affiliation': 'Department of Dental and Maxillofacial Radiology, Medical University of Warsaw, Nowogrodzka St 59, 02-006, Warsaw, Poland.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Górska', 'Affiliation': 'Department of Periodontology and Oral Mucosa Diseases, Medical Unversity of Warsaw, Miodowa St 18, 00-246, Warsaw, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Zaremba', 'Affiliation': 'Department of Periodontology and Oral Mucosa Diseases, Medical Unversity of Warsaw, Miodowa St 18, 00-246, Warsaw, Poland.'}]",Clinical oral investigations,['10.1007/s00784-018-2712-7']
541,31832721,Poor inhibitory control is associated with greater stimulation and less sedation following alcohol.,"RATIONALE AND OBJECTIVE


Poor inhibitory control is a well-established risk factor for alcohol use disorder (AUD). Similarly, greater sensitivity to the stimulant effects and less sensitivity to the sedative effects of alcohol are also strongly linked to risk for AUD. Traditionally, these two risk factors have been considered to be orthogonal, and thus they have been studied independently. However, recent evidence from animal and human studies suggests that they may be related. The current study examined the relationship between inhibitory control and subjective responses to alcohol in a sample of healthy young adults.
METHODS


Moderate social drinkers (N = 69) first completed the stop signal task to assess inhibitory control. They then participated in four sessions in which they received an oral dose of ethanol (0.8 g/kg) or placebo in alternating order, providing self-report measures of stimulation and sedation on the Biphasic Alcohol Effects Scale (BAES) at regular intervals.
RESULTS


Linear mixed effects models showed that poor inhibitory control was associated with greater stimulation and less sedation following alcohol compared with placebo.
CONCLUSION


These findings provide the first direct evidence that individuals with poor inhibitory control experience greater sensitivity to the rewarding, stimulant effects of alcohol, and less sensitivity to the negative, sedative effects. These findings suggest that inhibition and subjective response to alcohol are not independent risk factors, and that together they constitute a heightened profile of risk for AUD.",2020,"RESULTS


Linear mixed effects models showed that poor inhibitory control was associated with greater stimulation and less sedation following alcohol compared with placebo.
","['Moderate social drinkers (N\u2009=\u200969) first completed the', 'healthy young adults']","['placebo', 'stop signal task to assess inhibitory control', 'ethanol']",[],"[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0337676', 'cui_str': 'Social drinker (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}]",[],,0.0163805,"RESULTS


Linear mixed effects models showed that poor inhibitory control was associated with greater stimulation and less sedation following alcohol compared with placebo.
","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Weafer', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, MC3077, 5841 S. Maryland Ave., Chicago, IL, 60637, USA. jweafer@uky.edu.'}, {'ForeName': 'K Luan', 'Initials': 'KL', 'LastName': 'Phan', 'Affiliation': 'Department of Psychiatry and Behavioral Health, The Ohio State University, 1670 Upham Drive, Columbus, OH, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, MC3077, 5841 S. Maryland Ave., Chicago, IL, 60637, USA.'}]",Psychopharmacology,['10.1007/s00213-019-05420-y']
542,32492041,Corrected analysis of 'Using financial incentives to promote physical activity in American Indian adolescents: A randomized controlled trial' confirms conclusions.,,2020,,['American Indian adolescents'],[],[],"[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],[],,0.100604,,"[{'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Golzarri-Arroyo', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Indiana University-Bloomington, Indiana, United States of America.'}, {'ForeName': 'Xiwei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Indiana University-Bloomington, Indiana, United States of America.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Dickinson', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Indiana University-Bloomington, Indiana, United States of America.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Short', 'Affiliation': 'Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States of America.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Thompson', 'Affiliation': 'Department of Biostatistics and Epidemiology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States of America.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Allison', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Indiana University-Bloomington, Indiana, United States of America.'}]",PloS one,['10.1371/journal.pone.0233273']
543,30648998,Improving Nonvocal Critical Care Patients' Ease of Communication Using a Modified SPEACS-2 Program.,"OBJECTIVE


To evaluate the feasibility and impact of implementing the ""study of patient-nurse effectiveness with assisted communication strategies-2"" (SPEACS-2); a program to facilitate communication with nonvocal patients.
STUDY DESIGN


The plan-do-study-act quality improvement methodology guided the implementation of a modified SPEACS-2 program within a pre and posttest design. The Ease of Communication Scale (ECS) measured patients' communication difficulty, and care processes measured the program's success.
STUDY POPULATION


Nurses (N = 385) across 5 intensive care units were trained in SPEACS-2. We assessed 354 nonvocal patients (aged 18-95 years) requiring continued mechanical ventilation after withdrawal of heavy sedation. Patients were evaluated over one 2-week preintervention (n = 163) and two 3-week postintervention periods (n = 128; n = 63). A subsample of intervention patients (n = 204) completed the ECS.
RESULTS


Ease of Communication Scale scores improved significantly (p = .027) from baseline (mean 25.86 ± 12.2, n = 71) to postintervention period 2 (21.22 ± 12.2, n = 63). Nurses' use of communication techniques and compliance with communication plans of care incrementally increased after training.
CONCLUSIONS


Implementing SPEACS-2 demonstrated positive changes in patients' ease of communication and feasibility of incorporating evidence-based communication strategies into practice.",2020,Implementing SPEACS-2 demonstrated positive changes in patients' ease of communication and feasibility of incorporating evidence-based communication strategies into practice.,"['Patients were evaluated over one 2-week preintervention (n = 163) and two 3-week postintervention periods (n = 128; n = 63', 'Nurses (N = 385) across 5 intensive care units were trained in SPEACS-2', 'A subsample of intervention patients (n = 204) completed the ECS', '354 nonvocal patients (aged 18-95 years) requiring continued mechanical ventilation after withdrawal of heavy sedation']","['assisted communication strategies-2"" (SPEACS-2']","['Ease of Communication Scale (ECS', 'Communication Scale scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4517751', 'cui_str': 'Three hundred and eighty-five'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",354.0,0.0222001,Implementing SPEACS-2 demonstrated positive changes in patients' ease of communication and feasibility of incorporating evidence-based communication strategies into practice.,"[{'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Trotta', 'Affiliation': ''}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Hermann', 'Affiliation': ''}, {'ForeName': 'Rosemary C', 'Initials': 'RC', 'LastName': 'Polomano', 'Affiliation': ''}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Happ', 'Affiliation': ''}]",Journal for healthcare quality : official publication of the National Association for Healthcare Quality,['10.1097/JHQ.0000000000000163']
544,31378962,Evaluation of the Effect of 5 QT-Positive Drugs on the JTpeak Interval - An Analysis of ECGs From the IQ-CSRC Study.,"The JTpeak interval has been proposed as a new biomarker to demonstrate mixed ion channel effects, potentially leading to reduced late-stage electrocardiogram (ECG) monitoring for mildly QT-prolonging drugs. ECG waveforms from the IQ-CSRC study were used. Twenty healthy subjects were enrolled with 6 subjects on placebo and 9 subjects on each of 5 mildly QT-prolonging drugs - moxifloxacin, dofetilide, ondansetron, dolasetron, and quinine - and 1 negative drug, levocetirizine. A vector magnitude lead was derived from 12-lead ECGs, and measurements were made on a median beat from three 10-second replicates. Data were analyzed using a linear concentration-response model with QTcF and heart rate corrected JTpeak (JTpeak_c) as dependent variables. For moxifloxacin, dofetilide, and ondansetron, all pure hERG blockers, slopes of the concentration (C)-QTcF and C-JTpeak_c relationships were positive and statistically significant. With the prespecified linear model, the predicted effects on ΔΔQTcF and ΔΔJTpeak_c were 11.4 and 9.4 milliseconds for moxifloxacin at the geometric mean C max  on day 1, 9.0 and 11.7 milliseconds for dofetilide and 11.5, and 7.9 milliseconds for ondansetron, respectively. In contrast, dolasetron and quinine, both with additional ion channel effects, prolonged QTcF with a positive C-ΔQTcF slope and predicted ΔΔQTcF effect on day 1 of 6.2 and 11.4 milliseconds, whereas the C-ΔJTpeak_c slope and the predicted ΔΔJTpeak on day 1 were negative (-0.3 and -7.5 milliseconds per ng/mL). Pure hERG-blocking drugs prolonged both the QTc and the JTpeak_c intervals, whereas drugs with mixed ion channel effects, including peak sodium inhibition, prolonged QTcF but not the JTpeak_c interval.",2020,"Pure hERG-blocking drugs prolonged both the QTc and the JTpeak_c intervals, whereas drugs with mixed ion channel effects, including peak sodium inhibition, prolonged QTcF but not the JTpeak_c interval.",['Twenty healthy subjects were enrolled with 6 subjects on'],"['placebo', 'moxifloxacin, dofetilide, and ondansetron', 'moxifloxacin', '5 mildly QT-prolonging drugs - moxifloxacin, dofetilide, ondansetron, dolasetron, and quinine - and 1 negative drug, levocetirizine', 'ondansetron', '5 QT-Positive Drugs']","['JTpeak', 'concentration (C)-QTcF and C-JTpeak_c relationships', 'positive C-ΔQTcF slope and predicted ΔΔQTcF effect']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0114771', 'cui_str': 'dofetilide'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval (finding)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0209210', 'cui_str': 'Dolasetron'}, {'cui': 'C0034417', 'cui_str': 'Quinine'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1174893', 'cui_str': 'levocetirizine'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",20.0,0.0595594,"Pure hERG-blocking drugs prolonged both the QTc and the JTpeak_c intervals, whereas drugs with mixed ion channel effects, including peak sodium inhibition, prolonged QTcF but not the JTpeak_c interval.","[{'ForeName': 'Borje', 'Initials': 'B', 'LastName': 'Darpo', 'Affiliation': 'ERT, Rochester, New York, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Benson', 'Affiliation': 'Eli Lilly & Company, Indiana, USA.'}, {'ForeName': 'Randy', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': 'ERT, Rochester, New York, USA.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Dota', 'Affiliation': 'AstraZeneca, Goteborg, Sweden.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Ferber', 'Affiliation': 'Statistik Georg Ferber GmbH, Riehen, Switzerland.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Ferry', 'Affiliation': 'Clinical Pharmacology, Eisai, Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Venkat', 'Initials': 'V', 'LastName': 'Jarugula', 'Affiliation': 'Novartis, East Hannover, New Jersey, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Keirns', 'Affiliation': 'Retired; at the time of the IQ-CSRC study at Astellas, Northbrook, Illinois, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ortemann-Renon', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Thuan', 'Initials': 'T', 'LastName': 'Pham', 'Affiliation': 'ERT, Rochester, New York, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Riley', 'Affiliation': 'Pfizer Inc., Groton, Connecticut, USA.'}, {'ForeName': 'Nenad', 'Initials': 'N', 'LastName': 'Sarapa', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, Tennessee, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ticktin', 'Affiliation': 'ERT, Rochester, New York, USA.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Zareba', 'Affiliation': 'Cardiovascular Clinical Research Center, University of Rochester, New York, USA.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Couderc', 'Affiliation': 'ERT, Rochester, New York, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1502']
545,31330023,Pilot testing an app-based stress management intervention for cancer survivors.,"Psychosocial eHealth intervention programs for cancer survivors are still in their infancy, with inconsistent findings so far in the scientific literature. The aim of this study was to explore system use, usefulness, ease of use, and preliminary effects of Stress Proffen, an app-based cognitive-behavioral stress management intervention for patients with cancer. A feasibility pilot project tested the intervention with cancer survivors (N = 25). The intervention contained (a) one face-to-face introduction session, (b) 10 app-based modules with stress management educational material and exercises, and (c) one follow-up phone call. Post-intervention interviews were conducted and user log-data were extracted. Outcome measures-Perceived Stress Scale (PSS), Anxiety and Depression (Hospital Anxiety and Depression Scale [HADS]), Health-Related Quality of Life (HRQoL; SF-36), and Self-Regulatory Fatigue (SRF-18)-were completed at baseline and post-intervention. Participants were primarily women (84%), age 34-71 (mean 48) and represented a variety of cancer diagnoses (majority breast cancer: 40%). Twenty-two participants completed all (pre-post) questionnaires. Sixteen participants (67%) completed at least 7 of 10 modules within the 8-week study period. Post-intervention interviews described StressProffen as providing a new, appreciated, and easily accessible stress management tool for the cancer survivors. Dependent/paired t-tests showed significant pre-post intervention effects with significant decrease in stress (p = .008), anxiety (p = .019), and self-regulatory fatigue (p = .025), and improved HRQoL (Role Physical, General Health, Vitality, and Role Emotional, all p's <.01). App-based stress management interventions such as StressProffen can provide appreciated support for cancer survivors, should be easy to use, can provide significant stress reduction, and improve emotional well-being. Further testing in a randomized controlled trial is warranted and is in progress. Clinicaltrials.gov: NCT0293961.",2020,"Dependent/paired t-tests showed significant pre-post intervention effects with significant decrease in stress (p = .008), anxiety (p = .019), and self-regulatory fatigue (p = .025), and improved HRQoL (Role Physical, General Health, Vitality, and Role Emotional, all p's <.01).","['Sixteen participants (67%) completed at least 7 of 10 modules within the 8-week study period', 'cancer survivors', 'patients with cancer', 'cancer survivors (N = 25', 'Participants were primarily women (84%), age 34-71 (mean 48) and represented a variety of cancer diagnoses (majority breast cancer: 40']","['intervention contained (a) one face-to-face introduction session, (b) 10 app-based modules with stress management educational material and exercises, and (c) one follow-up phone call', 'StressProffen', 'app-based stress management intervention', 'Psychosocial eHealth intervention programs', 'Stress Proffen, an app-based cognitive-behavioral stress management intervention']","['stress', 'self-regulatory fatigue', 'HRQoL (Role Physical, General Health, Vitality, and Role Emotional', 'Outcome measures-Perceived Stress Scale (PSS), Anxiety and Depression (Hospital Anxiety and Depression Scale [HADS]), Health-Related Quality of Life (HRQoL; SF-36), and Self-Regulatory Fatigue (SRF-18)-were', 'anxiety']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C1293116', 'cui_str': 'Introduction'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale (assessment scale)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0037668', 'cui_str': 'Somatotropin-Releasing Factor 44'}]",22.0,0.051458,"Dependent/paired t-tests showed significant pre-post intervention effects with significant decrease in stress (p = .008), anxiety (p = .019), and self-regulatory fatigue (p = .025), and improved HRQoL (Role Physical, General Health, Vitality, and Role Emotional, all p's <.01).","[{'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Børøsund', 'Affiliation': 'Center for Shared Decision Making and Collaborative Care Research, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Cecilie', 'Initials': 'C', 'LastName': 'Varsi', 'Affiliation': 'Center for Shared Decision Making and Collaborative Care Research, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Clark', 'Affiliation': 'Department of Psychiatry and Psychology, College of Medicine and Science, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Shawna L', 'Initials': 'SL', 'LastName': 'Ehlers', 'Affiliation': 'Department of Psychiatry and Psychology, College of Medicine and Science, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Andrykowski', 'Affiliation': 'Department of Behavioral Science, College of Medicine, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Hilde Renate Sætre', 'Initials': 'HRS', 'LastName': 'Sleveland', 'Affiliation': 'Center for Shared Decision Making and Collaborative Care Research, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bergland', 'Affiliation': 'Center for Shared Decision Making and Collaborative Care Research, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Lise Solberg', 'Initials': 'LS', 'LastName': 'Nes', 'Affiliation': 'Center for Shared Decision Making and Collaborative Care Research, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}]",Translational behavioral medicine,['10.1093/tbm/ibz062']
546,31322739,"Patisiran Pharmacokinetics, Pharmacodynamics, and Exposure-Response Analyses in the Phase 3 APOLLO Trial in Patients With Hereditary Transthyretin-Mediated (hATTR) Amyloidosis.","Hereditary transthyretin-mediated (hATTR) amyloidosis is an inherited, rapidly progressive, life-threatening disease caused by deposition of abnormal transthyretin protein. Patisiran is an RNA interference therapeutic comprising a novel, small interfering ribonucleic acid (ALN-18328) formulated in a lipid nanoparticle targeted to inhibit hepatic transthyretin protein synthesis. The lipid nanoparticle also contains 2 novel lipid excipients (DLin-MC3-DMA and PEG 2000  -C-DMG). Here we report patisiran pharmacokinetics (PK), pharmacodynamics (PD), and exposure-response analyses from the phase 3 APOLLO trial, in which patients with hATTR amyloidosis with polyneuropathy were randomized 2:1 to receive patisiran 0.3 mg/kg or placebo intravenously every 3 weeks over 18 months. In patisiran-treated patients, mean maximum reduction in serum transthyretin level from baseline was 87.8%. Patisiran PK exposure was stable following chronic dosing. There were no meaningful differences in PK exposure, serum transthyretin reduction, and efficacy (change from baseline in modified Neuropathy Impairment Score+7) across all subgroups analyzed (age, sex, race, body weight, genotype status of valine-to-methionine mutation at position 30 [V30M] and non-V30M, prior use of tetramer stabilizers, mild/moderate renal impairment, and mild hepatic impairment). transthyretin reduction and efficacy were similar across the interpatient PK exposure range for ALN-18328. There was no trend in the incidence of adverse events or serious adverse events across the interpatient PK exposure range for all 3 analytes. Incidence of antidrug antibodies was low (3.4%) and transient, with no impact on PK, PD, efficacy, or safety. The patisiran dosing regimen of 0.3 mg/kg every 3 weeks is appropriate for all patients with hATTR amyloidosis.",2020,There was no trend in the incidence of adverse events or serious adverse events across the interpatient PK exposure range for all 3 analytes.,"['patients with hATTR amyloidosis', 'Patients With Hereditary Transthyretin-Mediated (hATTR) Amyloidosis', 'patients with hATTR amyloidosis with polyneuropathy']",['patisiran 0.3 mg/kg or placebo'],"['Patisiran Pharmacokinetics, Pharmacodynamics, and Exposure-Response Analyses', 'patisiran pharmacokinetics (PK), pharmacodynamics (PD), and exposure-response analyses', 'Incidence of antidrug antibodies', 'serum transthyretin level', 'PK exposure, serum transthyretin reduction, and efficacy', 'incidence of adverse events or serious adverse events', 'PK, PD, efficacy, or safety', 'transthyretin reduction and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002726', 'cui_str': 'Amyloidosis'}, {'cui': 'C0439660', 'cui_str': 'Hereditary (qualifier value)'}, {'cui': 'C0032923', 'cui_str': 'Transthyretin'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}]","[{'cui': 'C3896714', 'cui_str': 'patisiran'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3896714', 'cui_str': 'patisiran'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0032923', 'cui_str': 'Transthyretin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0398156,There was no trend in the incidence of adverse events or serious adverse events across the interpatient PK exposure range for all 3 analytes.,"[{'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Goel', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Husain', 'Initials': 'H', 'LastName': 'Attarwala', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Marianne T', 'Initials': 'MT', 'LastName': 'Sweetser', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Clausen', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Gabriel J', 'Initials': 'GJ', 'LastName': 'Robbie', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1480']
547,31835096,"""What matters to you?"": A randomized controlled effectiveness trial, Using Systematic Idiographic Assessment as an intervention to Increase Adolescents' perceived control of their mental health.","INTRODUCTION


Over the last decades, many Western countries have seen an increase in mental health difficulties in the adolescent population. Among Norwegian adolescents, internalizing symptoms are most prevalent, and 10%-38% of adolescents seek out primary health care services for mental health problems. This study examined whether an idiographic measure designed for adolescents called Assert, which uses variables individually selected by the adolescents, could improve user involvement, locus of control, mental health, and quality of life.
METHODS


This study conducted a randomized controlled effectiveness trial using Assert in primary healthcare. A community sample of 150 Norwegian adolescents aged 12-23 years (M = 16.2; SD = 2.2) were randomized to the Assert or control group. Of the participants 27 (18%) were male. The adolescents and 52 counsellors from primary healthcare services responded to online questionnaires. Of the counselors, 92.8% were female and trained in the use of systematic idiographic assessment.
RESULTS


Adolescents who used Assert scored significantly lower on external LoC, attributing less of their mental health improvement to chance, fate, or luck. However, the intervention showed no effect on the symptoms of mental health, QoL, or user involvement.
CONCLUSIONS


Using Assert in primary healthcare may enhance adolescents' sense of being able to influence their life circumstances and mental health by allowing them more control of their treatment. However, this approach might not be successful in reducing symptoms.",2020,"RESULTS


Adolescents who used Assert scored significantly lower on external LoC, attributing less of their mental health improvement to chance, fate, or luck.","['150 Norwegian adolescents aged 12-23 years (M = 16.2; SD\xa0=\xa02.2', 'primary healthcare', 'participants 27 (18%) were male']",[],"['external LoC', 'mental health difficulties', 'symptoms of mental health, QoL, or user involvement']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0337812', 'cui_str': 'Norwegians (ethnic group)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319690', 'cui_str': '16.2'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0086582', 'cui_str': 'Males'}]",[],"[{'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}]",,0.117159,"RESULTS


Adolescents who used Assert scored significantly lower on external LoC, attributing less of their mental health improvement to chance, fate, or luck.","[{'ForeName': 'Thomas Kristian', 'Initials': 'TK', 'LastName': 'Tollefsen', 'Affiliation': 'Center for Child and Adolescent Mental Health, Eastern and Southern Norway, Norway; University of Oslo, Norway. Electronic address: thomas.tollefsen@r-bup.no.'}, {'ForeName': 'Simon-Peter', 'Initials': 'SP', 'LastName': 'Neumer', 'Affiliation': 'Center for Child and Adolescent Mental Health, Eastern and Southern Norway, Norway.'}, {'ForeName': 'Turid Suzanne', 'Initials': 'TS', 'LastName': 'Berg-Nielsen', 'Affiliation': 'Center for Child and Adolescent Mental Health, Eastern and Southern Norway, Norway; Norwegian University of Science and Technology, Trondheim, Norway.'}]",Journal of adolescence,['10.1016/j.adolescence.2019.11.006']
548,31870605,"Reducing Tobacco Smoke Exposure in High-Risk Infants: A Randomized, Controlled Trial.","OBJECTIVE


To evaluate a hospital-initiated intervention to reduce tobacco smoke exposure in infants in the neonatal intensive care unit.
STUDY DESIGN


A randomized, controlled trial compared motivational interviewing plus financial incentives with conventional care on infant urine cotinine at 1 and 4 months' follow-up. Mothers of infants in the neonatal intensive care unit (N = 360) who reported a smoker living in the home were enrolled. Motivational interviewing sessions were delivered in both the hospital and the home. Financial incentives followed session attendance and negative infant cotinine tests postdischarge.
RESULTS


The intervention effect on infant cotinine was not significant, except among mothers who reported high baseline readiness/ability to protect their infant (P ≤ .01) and mothers who completed the study within 6 months postdischarge (per protocol; P ≤ .05). Fewer mothers in the motivational interviewing plus financial incentives condition were smoking postdischarge (P ≤ .01). More mothers in the motivational interviewing plus financial incentives group reported a total home and car smoking ban at follow-up (P ≤ .05).
CONCLUSIONS


Motivational interviewing combined with financial incentives reduced infant tobacco smoke exposure in a subset of women who were ready/able to protect their infant. The intervention also resulted in less maternal smoking postpartum. More robust interventions that include maternal and partner/household smoking cessation are likely needed to reduce the costly effects of tobacco smoke exposure on children and their families.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT01726062.",2020,Fewer mothers in the motivational interviewing plus financial incentives condition were smoking postdischarge (P ≤ .01).,"['Mothers of infants in the neonatal intensive care unit (N\xa0=\xa0360) who reported a smoker living in the home were enrolled', 'infants in the neonatal intensive care unit', 'High-Risk Infants']","['motivational interviewing plus financial incentives with conventional care', 'Motivational interviewing sessions', 'Motivational interviewing combined with financial incentives']","['infant cotinine', 'total home and car smoking', 'infant tobacco smoke exposure', 'maternal smoking postpartum', 'smoking postdischarge']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0419437', 'cui_str': 'High risk infant (finding)'}]","[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0004381', 'cui_str': 'Automobiles'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0439994', 'cui_str': 'Tobacco smoke (substance)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]",,0.104123,Fewer mothers in the motivational interviewing plus financial incentives condition were smoking postdischarge (P ≤ .01).,"[{'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Stotts', 'Affiliation': 'Department of Family and Community Medicine, McGovern Medical School at UTHealth, Houston, TX.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Northrup', 'Affiliation': 'Department of Family and Community Medicine, McGovern Medical School at UTHealth, Houston, TX.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at UTHealth, Houston, TX.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Suchting', 'Affiliation': 'Department of Psychiatry and Behavioral Science, McGovern Medical School at UTHealth, Houston, TX.'}, {'ForeName': 'Melbourne F', 'Initials': 'MF', 'LastName': 'Hovell', 'Affiliation': 'Center for Behavioral Epidemiology and Community Health, School of Public Health, San Diego State University, San Diego, CA.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at UTHealth, Houston, TX.'}, {'ForeName': 'Yolanda R', 'Initials': 'YR', 'LastName': 'Villarreal', 'Affiliation': 'Department of Family and Community Medicine, McGovern Medical School at UTHealth, Houston, TX.'}, {'ForeName': 'Joy M', 'Initials': 'JM', 'LastName': 'Schmitz', 'Affiliation': 'Department of Psychiatry and Behavioral Science, McGovern Medical School at UTHealth, Houston, TX.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Velasquez', 'Affiliation': 'School of Social Work, University of Texas, Austin, TX.'}, {'ForeName': 'S Katharine', 'Initials': 'SK', 'LastName': 'Hammond', 'Affiliation': 'Division of Environmental Health, School of Public Health, University of California, Berkeley, CA.'}, {'ForeName': 'Eunha', 'Initials': 'E', 'LastName': 'Hoh', 'Affiliation': 'Division of Environmental Health, School of Public Health, San Diego State University, San Diego, CA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Tyson', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at UTHealth, Houston, TX.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.10.070']
549,31500849,Effect of remote ischaemic conditioning on clinical outcomes in patients with acute myocardial infarction (CONDI-2/ERIC-PPCI): a single-blind randomised controlled trial.,"BACKGROUND


Remote ischaemic conditioning with transient ischaemia and reperfusion applied to the arm has been shown to reduce myocardial infarct size in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). We investigated whether remote ischaemic conditioning could reduce the incidence of cardiac death and hospitalisation for heart failure at 12 months.
METHODS


We did an international investigator-initiated, prospective, single-blind, randomised controlled trial (CONDI-2/ERIC-PPCI) at 33 centres across the UK, Denmark, Spain, and Serbia. Patients (age >18 years) with suspected STEMI and who were eligible for PPCI were randomly allocated (1:1, stratified by centre with a permuted block method) to receive standard treatment (including a sham simulated remote ischaemic conditioning intervention at UK sites only) or remote ischaemic conditioning treatment (intermittent ischaemia and reperfusion applied to the arm through four cycles of 5-min inflation and 5-min deflation of an automated cuff device) before PPCI. Investigators responsible for data collection and outcome assessment were masked to treatment allocation. The primary combined endpoint was cardiac death or hospitalisation for heart failure at 12 months in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT02342522) and is completed.
FINDINGS


Between Nov 6, 2013, and March 31, 2018, 5401 patients were randomly allocated to either the control group (n=2701) or the remote ischaemic conditioning group (n=2700). After exclusion of patients upon hospital arrival or loss to follow-up, 2569 patients in the control group and 2546 in the intervention group were included in the intention-to-treat analysis. At 12 months post-PPCI, the Kaplan-Meier-estimated frequencies of cardiac death or hospitalisation for heart failure (the primary endpoint) were 220 (8·6%) patients in the control group and 239 (9·4%) in the remote ischaemic conditioning group (hazard ratio 1·10 [95% CI 0·91-1·32], p=0·32 for intervention versus control). No important unexpected adverse events or side effects of remote ischaemic conditioning were observed.
INTERPRETATION


Remote ischaemic conditioning does not improve clinical outcomes (cardiac death or hospitalisation for heart failure) at 12 months in patients with STEMI undergoing PPCI.
FUNDING


British Heart Foundation, University College London Hospitals/University College London Biomedical Research Centre, Danish Innovation Foundation, Novo Nordisk Foundation, TrygFonden.",2019,"INTERPRETATION


Remote ischaemic conditioning does not improve clinical outcomes (cardiac death or hospitalisation for heart failure) at 12 months in patients with STEMI undergoing PPCI.
","['Between Nov 6, 2013, and March 31, 2018, 5401 patients', 'University College London Hospitals/University College London', 'Patients (age >18 years) with suspected STEMI and who were eligible for PPCI', 'patients upon hospital arrival or loss to follow-up, 2569 patients in the control group and 2546 in the intervention group were included in the intention-to-treat analysis', 'patients with STEMI undergoing PPCI', 'patients with acute myocardial infarction (CONDI-2/ERIC-PPCI', 'patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI']","['standard treatment (including a sham simulated remote ischaemic conditioning intervention at UK sites only) or remote ischaemic conditioning treatment (intermittent ischaemia and reperfusion applied to the arm through four cycles of 5-min inflation and 5-min deflation of an automated cuff device) before PPCI', 'remote ischaemic conditioning']","['myocardial infarct size', 'cardiac death or hospitalisation for heart failure', 'incidence of cardiac death and hospitalisation for heart failure', 'Kaplan-Meier-estimated frequencies of cardiac death or hospitalisation for heart failure', 'clinical outcomes (cardiac death or hospitalisation for heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1318493', 'cui_str': 'Inflation'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1720943', 'cui_str': 'Product-Limit Method'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",2569.0,0.207272,"INTERPRETATION


Remote ischaemic conditioning does not improve clinical outcomes (cardiac death or hospitalisation for heart failure) at 12 months in patients with STEMI undergoing PPCI.
","[{'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Hausenloy', 'Affiliation': 'The Hatter Cardiovascular Institute, University College London, London, UK; National Institute of Health Research Biomedical Research Centre at University College London Hospitals, Research & Development, London, UK; Cardiovascular & Metabolic Disorders Program, Duke-National University of Singapore Medical School, Singapore; National Heart Research Institute Singapore, National Heart Centre, Singapore; Yong Loo Lin School of Medicine, National University Singapore, Singapore; Centro de Biotecnologia-FEMSA, Tecnologico de Monterrey, Monterrey, Mexico. Electronic address: d.hausenloy@ucl.ac.uk.'}, {'ForeName': 'Rajesh K', 'Initials': 'RK', 'LastName': 'Kharbanda', 'Affiliation': 'Oxford Heart Centre, Oxford University Hospitals National Health Service Trust, Oxford, UK; Department of Cardiovascular Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ulla Kristine', 'Initials': 'UK', 'LastName': 'Møller', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Ramlall', 'Affiliation': 'The Hatter Cardiovascular Institute, University College London, London, UK; University Hospital Southampton National Health Service Foundation Trust, Southampton, UK.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Aarøe', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Butler', 'Affiliation': 'Department of Cardiology, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, UK.'}, {'ForeName': 'Heerajnarain', 'Initials': 'H', 'LastName': 'Bulluck', 'Affiliation': 'Department of Cardiology, Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Clayton', 'Affiliation': 'Clinical Trials Unit and Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Dana', 'Affiliation': 'Portsmouth Hospitals National Health Service Trust, Portsmouth, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Dodd', 'Affiliation': 'Clinical Trials Unit and Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Engstrom', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Evans', 'Affiliation': 'Clinical Trials Unit and Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Jens Flensted', 'Initials': 'JF', 'LastName': 'Lassen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Erika Frischknecht', 'Initials': 'EF', 'LastName': 'Christensen', 'Affiliation': 'Prehospital Emergency Medical Services, Central Denmark Region, Aarhus, Denmark.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Garcia-Ruiz', 'Affiliation': 'Instituto de Investigación Sanitaria del Principado de Asturias, Hospital Universitario de Cabueñes, Oviedo, Spain; Centro Nacional de Investigaciones Cardiovasculares, Madrid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Madrid, Spain.'}, {'ForeName': 'Diana A', 'Initials': 'DA', 'LastName': 'Gorog', 'Affiliation': 'Department of Cardiology, Lister Hospital, East and North Hertfordshire National Health Service Trust, Stevenage, UK; National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Hjort', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Houghton', 'Affiliation': 'Servicio de Atención Médica de Urgencia-Asturias, Oviedo, Spain.'}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Ibanez', 'Affiliation': 'Centro Nacional de Investigaciones Cardiovasculares, Madrid, Spain; Centro de Investigacion Biomedica En Red Cardiovascular, Madrid, Spain; IIS-Fundación Jiménez Díaz University Hospital, Madrid, Spain.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Knight', 'Affiliation': 'Clinical Trials Unit and Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Freddy K', 'Initials': 'FK', 'LastName': 'Lippert', 'Affiliation': 'Prehospital Emergency Medical Services, Capital Region of Denmark, Denmark.'}, {'ForeName': 'Jacob T', 'Initials': 'JT', 'LastName': 'Lønborg', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maeng', 'Affiliation': 'The Hatter Cardiovascular Institute, University College London, London, UK.'}, {'ForeName': 'Dejan', 'Initials': 'D', 'LastName': 'Milasinovic', 'Affiliation': 'Department of Cardiology, Clinical Centre of Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'More', 'Affiliation': 'Lancashire Cardiac Centre, Blackpool Teaching Hospitals National Health Service Foundation Trust, Blackpool, UK.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Nicholas', 'Affiliation': 'Clinical Trials Unit and Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Lisette Okkels', 'Initials': 'LO', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Perkins', 'Affiliation': 'Clinical Trials Unit and Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Nebojsa', 'Initials': 'N', 'LastName': 'Radovanovic', 'Affiliation': 'Cardiology Clinic, Clinical Centre of Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; Emergency Centre, Clinical Centre of Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Roby D', 'Initials': 'RD', 'LastName': 'Rakhit', 'Affiliation': 'Royal Free Hospital London and Institute of Cardiovascular Science, University College London, London, UK.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Ravkilde', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Alisdair D', 'Initials': 'AD', 'LastName': 'Ryding', 'Affiliation': 'Department of Cardiology, Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Schmidt', 'Affiliation': 'The Hatter Cardiovascular Institute, University College London, London, UK.'}, {'ForeName': 'Ingunn Skogstad', 'Initials': 'IS', 'LastName': 'Riddervold', 'Affiliation': 'Prehospital Emergency Medical Services, Central Denmark Region, Aarhus, Denmark.'}, {'ForeName': 'Henrik Toft', 'Initials': 'HT', 'LastName': 'Sørensen', 'Affiliation': 'Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Goran', 'Initials': 'G', 'LastName': 'Stankovic', 'Affiliation': 'Cardiology Clinic, Clinical Centre of Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; Department for Diagnostic and Catheterization Laboratories, Clinical Centre of Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Madhusudhan', 'Initials': 'M', 'LastName': 'Varma', 'Affiliation': 'The Heart Centre, North Cumbria University Hospitals National Health Service Trust, Carlisle, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Webb', 'Affiliation': ""King's College Hospital, King's Health Partnership, London, UK.""}, {'ForeName': 'Christian Juhl', 'Initials': 'CJ', 'LastName': 'Terkelsen', 'Affiliation': 'The Hatter Cardiovascular Institute, University College London, London, UK.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Greenwood', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK; Leeds Teaching Hospitals National Health Service Trust, Leeds, UK.'}, {'ForeName': 'Derek M', 'Initials': 'DM', 'LastName': 'Yellon', 'Affiliation': 'The Hatter Cardiovascular Institute, University College London, London, UK.'}, {'ForeName': 'Hans Erik', 'Initials': 'HE', 'LastName': 'Bøtker', 'Affiliation': 'The Hatter Cardiovascular Institute, University College London, London, UK. Electronic address: haboet@rm.dk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)32039-2']
550,31896121,Plasma ammonia concentrations in extremely low birthweight infants in the first week after birth: secondary analysis from the ProVIDe randomized clinical trial.,"BACKGROUND


Little is known about normative ammonia concentrations in extremely low birthweight (ELBW) babies and whether these vary with birth characteristics. We aimed to determine ammonia concentrations in ELBW babies in the first week after birth and relationships with neonatal characteristics and protein intake.
METHODS


Arterial blood samples for the measurement of plasma ammonia concentration were collected within 7 days of birth from ProVIDe trial participants in six New Zealand neonatal intensive care units.
RESULTS


Three hundred and twenty-two babies were included. Median (range) gestational age was 25.7 (22.7-31.6) weeks. Median (interquartile range (IQR)) ammonia concentration was 102 (80-131) µg/dL. There were no statistically significant associations between ammonia concentrations and birthweight or sex. Ammonia concentrations were weakly correlated with mean total (Spearman's r s  = 0.11, P = 0.047) and intravenous (r s  = 0.13, P = 0.02) protein intake from birth, gestational age at birth (r s  = -0.13, P = 0.02) and postnatal age (r s  = -0.13, P = 0.02).
CONCLUSIONS


Plasma ammonia concentrations in ELBW babies are similar to those of larger and more mature babies and only weakly correlated with protein intake. Currently, recommended thresholds for investigation of hyperammonaemia are appropriate for ELBW babies. Protein intake should not be limited by concerns about potential hyperammonaemia.",2020,ammonia concentration was 102 (80-131) µg/dL. There were no statistically significant associations between ammonia concentrations and birthweight or sex.,"['extremely low birthweight infants', 'Three hundred and twenty-two babies were included', 'trial participants in\xa0six New Zealand neonatal intensive care units']",[],"['ammonia concentration', 'Plasma ammonia concentrations', 'Median (interquartile range (IQR', 'plasma ammonia concentration', 'Ammonia concentrations', 'ammonia concentrations and birthweight or sex']","[{'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4517712', 'cui_str': 'Three hundred and twenty-two'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}]",[],"[{'cui': 'C0002607', 'cui_str': 'Ammonia'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]",,0.184577,ammonia concentration was 102 (80-131) µg/dL. There were no statistically significant associations between ammonia concentrations and birthweight or sex.,"[{'ForeName': 'Barbara E', 'Initials': 'BE', 'LastName': 'Cormack', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Harding', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Crowther', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Lynn', 'Affiliation': ""Neonatal Intensive Care Unit, Christchurch Women's Hospital, Christchurch, New Zealand.""}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Nair', 'Affiliation': 'Newborn Intensive Care Unit, Waikato Hospital, Hamilton, New Zealand.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hewson', 'Affiliation': 'Neonatal Intensive Care Unit, Wellington Hospital, Wellington, New Zealand.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Meyer', 'Affiliation': 'Neonatal Unit, Middlemore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Broadbent', 'Affiliation': 'Neonatal Intensive Care Unit, Dunedin Hospital, Dunedin, New Zealand.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Webster', 'Affiliation': 'LabPlus, Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Glamuzina', 'Affiliation': 'National Adult and Paediatric Metabolic Service, Auckland, New Zealand.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Ryder', 'Affiliation': 'National Adult and Paediatric Metabolic Service, Auckland, New Zealand.'}, {'ForeName': 'Frank H', 'Initials': 'FH', 'LastName': 'Bloomfield', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand. f.bloomfield@auckland.ac.nz.'}]",Pediatric research,['10.1038/s41390-019-0730-z']
551,31006069,"Pedicle screw insertion with patient-specific 3D-printed guides based on low-dose CT scan is more accurate than free-hand technique in spine deformity patients: a prospective, randomized clinical trial.","BACKGROUND


Screw misplacement incidence can be as high as 15-30% in spine deformity surgery, with possible devastating consequences. Some technical solutions to prevent misplacement require expensive devices. MySpine TM  comprises a low-dose CT scan of the patient's spine to build a virtual model of the spine to plan the screw trajectories and a 3D-printed patient-specific guide system to prepare the screw trajectories and to implant the screws in the vertebrae in order to increase reproducibility and safety of the implants. The aim of this open-label, single-center, prospective randomized clinical trial with independent evaluation of outcomes was to compare the accuracy of free-hand insertion of pedicle screws to MySpine TM  3D-printed patient-specific guides.
METHODS


Twenty-nine patients undergoing surgical correction for spinal deformity were randomized to Group A (pedicle screws implantation with MySpine TM ) or Group B (free-hand implantation). Group A received 297 pedicle screws, and Group B 243 screws. Forty-three screws in Group A crossed over to free-hand implantation. Screw position was graded according to Gertzbein in grades 0, A, B or C, with grades 0 or A considered as ""safe area."" Total fluoroscopy dose and time were compared in six patients of each group.
RESULTS


Comparing the two study groups, we observed a statistically significant difference between the two groups (p < 0.05), with 96.1% of screws in the ""safe area"" in Group A versus a 82.9% in Group B. Group-A patients had a mean effective dose of 0.23 mSv compared to 0.82 mSv in Group B. Patient-specific, 3D-printed pedicle screw guides increase safety in a wide spectrum of deformity conditions. In addition, the total radiation dose is reduced, even considering the need of a low-dose preoperative CT for surgical planning.
LEVEL OF EVIDENCE


I. These slides can be retrieved under Electronic Supplementary Material.",2019,"Comparing the two study groups, we observed a statistically significant difference between the two groups (p < 0.05), with 96.1% of screws in the ""safe area"" in Group A versus a 82.9% in","['Twenty-nine patients undergoing surgical correction for spinal deformity', 'spine deformity patients']","['Group A (pedicle screws implantation with MySpine TM ) or Group B (free-hand implantation', 'Pedicle screw insertion with patient-specific 3D-printed guides based on low-dose CT scan', '297 pedicle screws', 'MySpine TM']",['Total fluoroscopy dose and time'],"[{'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0575157', 'cui_str': 'Deformity of spine (finding)'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0000768', 'cui_str': 'Birth Defects'}]","[{'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C1293259', 'cui_str': 'Hand implantation'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",29.0,0.0564761,"Comparing the two study groups, we observed a statistically significant difference between the two groups (p < 0.05), with 96.1% of screws in the ""safe area"" in Group A versus a 82.9% in","[{'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Cecchinato', 'Affiliation': 'GSpine4, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy. dott.cecchinato@gmail.com.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Berjano', 'Affiliation': 'GSpine4, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zerbi', 'Affiliation': 'GSpine4, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Damilano', 'Affiliation': 'GSpine4, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Redaelli', 'Affiliation': 'GSpine4, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Lamartina', 'Affiliation': 'GSpine4, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-019-05978-3']
552,31864068,Bifrontal tDCS applied to the dorsolateral prefrontal cortex in heavy drinkers: Influence on reward-triggered approach bias and alcohol consumption.,"Even though the ventromedial neural network (reward pathway) has been well documented to be a mediator for increased craving, the prefrontal cortex is receiving ever more attention for craving monitoring. In the current study, we examined whether causal modulation of the prefrontal cortex, and its associated neural network, diminishes reward-triggered approach bias (due to increased cognitive control), alcohol craving and consumption. Using a double-blind within-subjects design in a subclinical group of forty-five heavy drinkers, a single sham controlled session of bilateral transcranial direct current stimulation (tDCS) was applied to the dorsolateral prefrontal cortex (DLPFC). Following real and sham tDCS placing the anode over the right and cathode over the left DLPFC, a rewarded Go/NoGo paradigm was administrated to provoke behavioral biases (irrespective of the task goal) After the cognitive paradigm, alcohol consumption was examined using a beer taste test. Bifrontal tDCS resulted in a reduced reward-triggered approach bias and reduced alcohol consumption, but not self-reported craving. Interestingly, reward-triggered approach bias and alcohol consumption were reliably associated in the sham condition, but not in the tDCS condition. Reward-trigged approach biases might be a cognitive mechanism associated with alcohol prone behavior, and the role of the prefrontal network may be significant.",2020,"Bifrontal tDCS resulted in a reduced reward-triggered approach bias and reduced alcohol consumption, but not self-reported craving.","['subclinical group of forty-five heavy drinkers', 'heavy drinkers']",['bilateral transcranial direct current stimulation (tDCS'],"['reduced reward-triggered approach bias and reduced alcohol consumption', 'reward-triggered approach bias and alcohol consumption']","[{'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]",,0.0387061,"Bifrontal tDCS resulted in a reduced reward-triggered approach bias and reduced alcohol consumption, but not self-reported craving.","[{'ForeName': 'Marie-Anne', 'Initials': 'MA', 'LastName': 'Vanderhasselt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium; Department of Head and Skin, Unit of Psychiatry and Medical Psychology, Ghent University, Belgium. Electronic address: MarieAnne.Vanderhasselt@Ugent.be.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Allaert', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium; Department of Head and Skin, Unit of Psychiatry and Medical Psychology, Ghent University, Belgium.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'De Raedt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'Department of Head and Skin, Unit of Psychiatry and Medical Psychology, Ghent University, Belgium; Department of Psychiatry, Free University Brussels; Eindhoven University of Technology, Department of Electrical Engineering, Eindhoven, the Netherlands.'}, {'ForeName': 'Ruth M', 'Initials': 'RM', 'LastName': 'Krebs', 'Affiliation': 'Department of Experimental Psychology, Ghent University, Belgium.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Herremans', 'Affiliation': 'Department of Head and Skin, Unit of Psychiatry and Medical Psychology, Ghent University, Belgium.'}]",Brain and cognition,['10.1016/j.bandc.2019.105512']
553,31853899,Somatosensory changes in Chinese patients after coronectomy vs. total extraction of mandibular third molar: a prospective study.,"OBJECTIVES


This study aimed to quantitatively compare the somatosensory function changes of inferior alveolar nerve (IAN) after mandibular third molar extraction with a surgery protocol of coronectomy, as opposed to the conventional method.
MATERIALS AND METHODS


Patients with a lower third molar directly contacting IAN were recruited and assigned either to a test group (coronectomy group) or a control group (conventional extraction). A standardized quantitative sensory testing (QST) battery was performed for four times: one week before surgery and the second, seventh, and 28th days after surgery. Z-scores and the loss/gain coding system were applied for each participant.
RESULTS


A total of 140 molars (test group: n = 91, control group: n = 49) were enrolled. The sensitivity of the mechanical detection threshold (MDT) and pressure pain threshold (PPT) significantly increased after surgery more than before surgery in both groups (P ≤ 0.001). After the surgery, the sensitivities of the cold detection threshold (CDT), cold pain threshold (CPT), and heat pain threshold (HPT) were significantly higher in the test group than in the control group (P ≤ 0.027). The risk of IANI was significantly larger (P = 0.041) in the test group than in the control group.
CONCLUSIONS


QST was a sensitive way to detect somatosensory abnormalities even with no subjective complaint caused by surgery. Coronectomy had less influence on IAN function than conventional total extraction.
CLINICAL RELEVANCE


The somatosensory function changes after mandibular third molar extraction were quantitatively studied, and coronectomy was proved a reliable alternation to reduce IAN injury rate.",2020,The sensitivity of the mechanical detection threshold (MDT) and pressure pain threshold (PPT) significantly increased after surgery more than before surgery in both groups (P ≤ 0.001).,"['Patients with a lower third molar directly contacting IAN', 'A total of 140 molars (test group: n\u2009=\u200991, control group: n\u2009=\u200949) were enrolled', 'Chinese patients after coronectomy vs. total extraction of mandibular third molar']","['QST', 'test group (coronectomy group) or a control group (conventional extraction']","['sensitivity of the mechanical detection threshold (MDT) and pressure pain threshold (PPT', 'IAN function', 'risk of IANI', 'Z-scores and the loss/gain coding system', 'sensitivities of the cold detection threshold (CDT), cold pain threshold (CPT), and heat pain threshold (HPT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442051', 'cui_str': 'Lower third (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}]","[{'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0018837', 'cui_str': 'Heat'}]",140.0,0.0422519,The sensitivity of the mechanical detection threshold (MDT) and pressure pain threshold (PPT) significantly increased after surgery more than before surgery in both groups (P ≤ 0.001).,"[{'ForeName': 'Zi-Yu', 'Initials': 'ZY', 'LastName': 'Yan', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, 22 South Street Zhong Guan Cun, Haidian District, Beijing, 100081, China.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Yan', 'Affiliation': 'Department of Medical Statistics, Peking University Clinical Research Institute, Beijing, China.'}, {'ForeName': 'Chuan-Bin', 'Initials': 'CB', 'LastName': 'Guo', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, 22 South Street Zhong Guan Cun, Haidian District, Beijing, 100081, China.'}, {'ForeName': 'Qiu-Fei', 'Initials': 'QF', 'LastName': 'Xie', 'Affiliation': 'Department of Prosthodontics and Center for Oral Functional Diagnosis, Treatment and Research, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Guang-Ju', 'Initials': 'GJ', 'LastName': 'Yang', 'Affiliation': 'Department of Prosthodontics and Center for Oral Functional Diagnosis, Treatment and Research, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Nian-Hui', 'Initials': 'NH', 'LastName': 'Cui', 'Affiliation': 'Department of Oral and Maxillofacial Surgery Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing, 100081, China. drcuinianhui@163.com.'}]",Clinical oral investigations,['10.1007/s00784-019-03169-4']
554,31849155,Effects of nicorandil infusion on ECG parameters in patients with unstable angina pectoris and percutaneous coronary intervention.,"BACKGROUND


Percutaneous coronary intervention (PCI) is effective in treating patients with acute coronary syndrome (ACS) but is associated with some serious complications. Nicorandil is an anti-anginal agent acting to improve microvascular circulation and to increase coronary blood flow. The objective of this article is to evaluate the effects of intracoronary injection followed with continuous intravenous injection of nicorandil on ECG parameters in patients with unstable angina pectoris (UA) undergoing PCI.
METHODS


A single-center, self-controlled clinical trial was conducted at the Second Hospital of Tianjin Medical University between January 2019 and April 2019. Sixty-three consecutive patients with UA who received coronary angiography and selective PCI were enrolled. ECG was recorded and analyzed before and 24 hr after nicorandil infusion.
RESULTS


Patients were divided into three groups: control group (n = 23, aged 63.43 ± 12.55 years), short-term, and prolonged use with nicorandil group (n = 20 and 20, aged 66.45 ± 8.06 years and 65.80 ± 9.49 years, respectively). Clinical characteristics and ECG parameters were similar before PCI among three groups (p > .05). In nicorandil treatment groups, intervals of QTd and Tp-e in patients post-PCI were significantly shorter than that in control and pre-PCI (p < .05).
CONCLUSIONS


Nicorandil infusion reduces QTd and Tp-e interval in patients with UA. Further studies will be needed to determine whether these electrophysiological changes are associated with a reduction of ventricular arrhythmias and improved outcomes.",2020,"In nicorandil treatment groups, intervals of QTd and Tp-e in patients post-PCI were significantly shorter than that in control and pre-PCI (p < .05).
","['patients with unstable angina pectoris and percutaneous coronary intervention', 'patients with unstable angina pectoris (UA) undergoing PCI.\nMETHODS\n\n\nA single-center, self-controlled clinical trial was conducted at the Second Hospital of Tianjin Medical University between January 2019 and April 2019', 'patients with acute coronary syndrome (ACS', 'Sixty-three consecutive patients with UA who received coronary angiography and selective PCI were enrolled', 'Patients were divided into three groups: control group (n\xa0=\xa023, aged 63.43\xa0±\xa012.55\xa0years), short-term, and prolonged use with nicorandil group (n\xa0=\xa020 and 20, aged 66.45\xa0±\xa08.06\xa0years and 65.80\xa0±\xa09.49\xa0years, respectively', 'patients with UA']","['Percutaneous coronary intervention (PCI', 'nicorandil', 'nicorandil infusion', 'Nicorandil', 'intracoronary injection']","['coronary blood flow', 'intervals of QTd and Tp-e', 'QTd and Tp-e interval', 'Clinical characteristics and ECG parameters', 'ECG parameters', 'ECG']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0068700', 'cui_str': 'Nicorandil'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0068700', 'cui_str': 'Nicorandil'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",63.0,0.0131258,"In nicorandil treatment groups, intervals of QTd and Tp-e in patients post-PCI were significantly shorter than that in control and pre-PCI (p < .05).
","[{'ForeName': 'Weiding', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Kangyin', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yin', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Mengqi', 'Initials': 'M', 'LastName': 'Gong', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Tse', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Guangping', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}]","Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc",['10.1111/anec.12736']
555,31338923,Effect of probiotic and prebiotic versus placebo on appetite in patients with major depressive disorder: post hoc analysis of a randomised clinical trial.,"BACKGROUND


Poor appetite and weight loss are common in melancholic depression. Probiotics and prebiotics have the capacity to affect host behaviour, appetite and weight change by modulating the gut microbiome. The aim of this post hoc analysis was to investigate the effect of supplementation with probiotic and prebiotic on appetite, in parallel with body mass index (BMI), weight and energy intake, in patients with major depressive disorder (MDD).
METHODS


We extracted data from a clinical trial with 81 patients. The participants were randomly assigned to receive probiotic (Lactobacillus helveticus and Bifidobacterium longum), prebiotic (galactooligosaccharide) or placebo for 8 weeks. Appetite, weight, BMI, dietary intake, serum leptin and physical activity were measured. Subjective appetite rating was evaluated every 2 weeks using visual analogue scales (VAS) to assess satiety, hunger, fullness and desire to eat. Serum leptin was measured by an enzyme-linked immunosorbent assay. Physical activity was measured using the international physical activity questionnaire. A repeated measures analysis of variance model was used to analyse VAS data and analysis of variance/analysis of covariance models for dietary intake, BMI, weight and leptin data.
RESULTS


VAS data analyses indicated no significant intervention-time interactions but did show a significant increase over time for desire to eat within the probiotic group (P = 0.025). No significant difference in either BMI or weight was seen among the groups. Energy intake and leptin were significantly increased in the probiotic group compared to the prebiotic.
CONCLUSIONS


Overall, probiotic supplementation for 8 weeks among MDD patients resulted in improvement of appetite, whereas prebiotic administration had no significant effect on appetite.",2020,"RESULTS


VAS data analyses indicated no significant intervention-time interactions but did show a significant increase over time for desire to eat within the probiotic group (P = 0.025).","['patients with major depressive disorder', 'patients with major depressive disorder (MDD', '81 patients']","['probiotic and prebiotic versus placebo', 'probiotic (Lactobacillus helveticus and Bifidobacterium longum), prebiotic (galactooligosaccharide) or placebo']","['Appetite, weight, BMI, dietary intake, serum leptin and physical activity', 'Physical activity', 'Subjective appetite rating', 'Serum leptin', 'visual analogue scales (VAS) to assess satiety, hunger, fullness and desire to eat', 'international physical activity questionnaire', 'BMI or weight', 'time for desire to eat', 'dietary intake, BMI, weight and leptin data', 'appetite']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0317592', 'cui_str': 'Lactobacillus helveticus'}, {'cui': 'C0314977', 'cui_str': 'Bifidobacterium longum'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.12947,"RESULTS


VAS data analyses indicated no significant intervention-time interactions but did show a significant increase over time for desire to eat within the probiotic group (P = 0.025).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kazemi', 'Affiliation': 'Nutrition Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Noorbala', 'Affiliation': 'Psychosomatic Medicine Research Center, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Djafarian', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetic, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of human nutrition and dietetics : the official journal of the British Dietetic Association,['10.1111/jhn.12675']
556,31318821,The Effect of Cognitive-Emotional Intervention on Growth and Posttraumatic Stress in Mothers of Children With Cancer: A Randomized Clinical Trial.,"BACKGROUND


To diminish the negative impact and improve the positive outcomes on the parents of children with cancer, it is crucial to attend to their problems. This is especially significant in the case of mothers as the main caregivers. The present study aimed at evaluating the efficiency of cognitive-emotional intervention on growth and posttraumatic stress in mothers of children with cancer hospitalized in the chemotherapy ward.
PROCEDURE


This randomized clinical trial was conducted on 100 mothers of children with cancer who presented to the chemotherapy ward of a hospital located in southeastern Iran in 2018. The eligible mothers were chosen and randomly assigned to intervention and control groups. Mothers in the intervention group as a whole received 5 sessions of cognitive-emotional intervention. The sessions were held twice a week, each lasting 60 to 90 minutes. Sixteen weeks after the intervention, posttest data were collected through the Posttraumatic Stress Disorder Checklist and Posttraumatic Growth Inventory. The data were then analyzed using SPSS 21 utilizing statistical tests including independent and paired t tests, χ, and covariance analysis.
RESULTS


The results show that the mean value of posttraumatic stress in mothers of children with cancer after cognitive-emotional training in the intervention group (25.92±5.29) was significantly lower than that in the control group (44.94±11.92; P=0.0001). Moreover, in the posttest, the mean value of posttraumatic growth in the intervention group (92.06±5.50) was significantly more than that in the control group (62.98±15.08; P=0.0001).
CONCLUSIONS


Alleviating posttraumatic stress, the cognitive-emotional intervention proposed in this research had a significant and positive impact on posttraumatic growth in mothers of children diagnosed with cancer. Therefore, implementing this intervention in the chemotherapy department and throughout the course of the children's treatment is highly recommended for their caregivers, especially mothers of children diagnosed with cancer.",2020,"Sixteen weeks after the intervention, posttest data were collected through the Posttraumatic Stress Disorder Checklist and Posttraumatic Growth Inventory.","['mothers of children diagnosed with cancer', 'parents of children with cancer', 'Mothers of Children With Cancer', 'mothers of children with cancer hospitalized in the chemotherapy ward', '100 mothers of children with cancer who presented to the chemotherapy ward of a hospital located in southeastern Iran in 2018']","['cognitive-emotional intervention', 'Cognitive-Emotional Intervention']","['mean value of posttraumatic stress', 'growth and posttraumatic stress', 'Posttraumatic Stress Disorder Checklist and Posttraumatic Growth Inventory', 'Growth and Posttraumatic Stress', 'mean value of posttraumatic growth']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C4704809', 'cui_str': 'Posttraumatic Growth'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",100.0,0.0381686,"Sixteen weeks after the intervention, posttest data were collected through the Posttraumatic Stress Disorder Checklist and Posttraumatic Growth Inventory.","[{'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Shakiba', 'Affiliation': 'Departments of Psychiatry.'}, {'ForeName': 'Arsalan', 'Initials': 'A', 'LastName': 'Latifi', 'Affiliation': 'Nursing, Nursing and Midwifery School.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Navidian', 'Affiliation': 'Department of Counseling, Community Nursing Research Center, Zahedan University of Medical Sciences, Zahedan, Iran.'}]",Journal of pediatric hematology/oncology,['10.1097/MPH.0000000000001558']
557,31086958,Plasma and tissue pharmacokinetics of fosfomycin in morbidly obese and non-obese surgical patients: a controlled clinical trial.,"OBJECTIVES


To assess the pharmacokinetics and tissue penetration of fosfomycin in obese and non-obese surgical patients.
METHODS


Fifteen obese patients undergoing bariatric surgery and 15 non-obese patients undergoing major intra-abdominal surgery received an intravenous single short infusion of 8 g of fosfomycin. Fosfomycin concentrations were determined by LC-MS/MS in plasma and microdialysate from subcutaneous tissue up to 8 h after dosing. The pharmacokinetic analysis was performed in plasma and interstitial fluid (ISF) by non-compartmental methods.
RESULTS


Thirteen obese patients (BMI 38-50 kg/m2) and 14 non-obese patients (BMI 0-29 kg/m2) were evaluable. The pharmacokinetics of fosfomycin in obese versus non-obese patients were characterized by lower peak plasma concentrations (468 ± 139 versus 594 ± 149 mg/L, P = 0.040) and higher V (24.4 ± 6.4 versus 19.0 ± 3.1 L, P = 0.010). The differences in AUC∞ were not significant (1275 ± 477 versus 1515 ± 352 mg·h/L, P = 0.16). The peak concentrations in subcutaneous tissue were reached rapidly and declined in parallel with the plasma concentrations. The drug exposure in tissue was nearly halved in obese compared with non-obese patients (AUC∞ 1052 ± 394 versus 1929 ± 725 mg·h/L, P = 0.0010). The tissue/plasma ratio (AUCISF/AUCplasma) was 0.86 ± 0.32 versus 1.27 ± 0.34 (P = 0.0047).
CONCLUSIONS


Whereas the pharmacokinetics of fosfomycin in plasma of surgical patients were only marginally different between obese and non-obese patients, the drug exposure in subcutaneous tissue was significantly lower in the obese patients.",2019,"The differences in AUC∞ were not significant (1275 ± 477 versus 1515 ± 352 mg·h/L, P = 0.16).","['Thirteen obese patients (BMI 38-50\u2009kg/m2) and 14 non-obese patients (BMI 0-29\u2009kg/m2) were evaluable', 'obese and non-obese surgical patients', 'obese versus non-obese patients', 'Fifteen obese patients undergoing bariatric surgery and 15 non-obese patients undergoing major intra-abdominal surgery received an', 'morbidly obese and non-obese surgical patients']",['intravenous single short infusion of 8\u2009g of fosfomycin'],"['Fosfomycin concentrations', 'peak plasma concentrations', 'tissue/plasma ratio (AUCISF/AUCplasma', 'peak concentrations in subcutaneous tissue', 'drug exposure in tissue', 'drug exposure in subcutaneous tissue', 'Plasma and tissue pharmacokinetics of fosfomycin']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1318217', 'cui_str': '8G'}, {'cui': 'C0016610', 'cui_str': 'Fosfomycin'}]","[{'cui': 'C0016610', 'cui_str': 'Fosfomycin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0278403', 'cui_str': 'Tela Subcutanea'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",15.0,0.0734296,"The differences in AUC∞ were not significant (1275 ± 477 versus 1515 ± 352 mg·h/L, P = 0.16).","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Dorn', 'Affiliation': 'Institute of Pharmacy, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Petroff', 'Affiliation': 'Clinical Trial Centre, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Neumann', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kratzer', 'Affiliation': 'Hospital Pharmacy, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Nahed', 'Initials': 'N', 'LastName': 'El-Najjar', 'Affiliation': 'Institute of Clinical Microbiology and Hygiene, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Dietrich', 'Affiliation': 'Integrated Research and Treatment Center (IFB) Adiposity Diseases, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Kloft', 'Affiliation': 'Department of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Zeitlinger', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Kees', 'Affiliation': 'Department of Anaesthesiology, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Frieder', 'Initials': 'F', 'LastName': 'Kees', 'Affiliation': 'Department of Pharmacology, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Wrigge', 'Affiliation': 'Integrated Research and Treatment Center (IFB) Adiposity Diseases, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Simon', 'Affiliation': 'Integrated Research and Treatment Center (IFB) Adiposity Diseases, University of Leipzig, Leipzig, Germany.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz203']
558,31106377,Non-lytic antibiotic treatment in community-acquired pneumococcal pneumonia does not attenuate inflammation: the PRISTINE trial.,"BACKGROUND


The inflammatory response in pneumococcal infection is primarily driven by immunoreactive bacterial cell wall components [lipoteichoic acid (LTA)]. An acute release of these components occurs when pneumococcal infection is treated with β-lactam antibiotics.
OBJECTIVES


We hypothesized that non-lytic rifampicin compared with lytic β-lactam antibiotic treatment would attenuate the inflammatory response in patients with pneumococcal pneumonia.
METHODS


In the PRISTINE (Pneumonia treated with RIfampicin aTtenuates INflammation) trial, a randomized, therapeutic controlled, exploratory study in patients with community-acquired pneumococcal pneumonia, we looked at LTA release and inflammatory and clinical response during treatment with both rifampicin and β-lactam compared with treatment with β-lactam antibiotics only. The trial is registered in the Dutch trial registry, number NTR3751 (European Clinical Trials Database number 2012-003067-22).
RESULTS


Forty-one patients with community-acquired pneumonia were included; 17 of them had pneumococcal pneumonia. LTA release, LTA-mediated inflammatory responses, clinical outcomes, inflammatory biomarkers and transcription profiles were not different between treatment groups.
CONCLUSIONS


The PRISTINE study demonstrated the feasibility of adding rifampicin to β-lactam antibiotics in the treatment of community-acquired pneumococcal pneumonia, but, despite solid in vitro and experimental animal research evidence, failed to demonstrate a difference in plasma LTA concentrations and subsequent inflammatory and clinical responses. Most likely, an inhibitory effect of human plasma contributes to the low immune response in these patients. In addition, LTA plasma concentration could be too low to mount a response via Toll-like receptor 2 in vitro, but may nonetheless have an effect in vivo.",2019,"LTA release, LTA-mediated inflammatory responses, clinical outcomes, inflammatory biomarkers and transcription profiles were not different between treatment groups.
","['community-acquired pneumococcal pneumonia', 'patients with pneumococcal pneumonia', 'Forty-one patients with community-acquired pneumonia were included; 17 of them had pneumococcal pneumonia', 'patients with community-acquired pneumococcal pneumonia']","['lytic β-lactam antibiotic treatment', 'rifampicin and β-lactam', 'rifampicin to β-lactam antibiotics', 'rifampicin', 'RIfampicin', 'β-lactam antibiotics only']","['LTA release, LTA-mediated inflammatory responses, clinical outcomes, inflammatory biomarkers and transcription profiles', 'inflammatory response']","[{'cui': 'C0456394', 'cui_str': 'Community acquired (qualifier value)'}, {'cui': 'C0155862', 'cui_str': 'Pneumonia, Pneumococcal'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0439680', 'cui_str': 'Lytic (qualifier value)'}, {'cui': 'C0022914', 'cui_str': 'Lactams'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}]","[{'cui': 'C2729610', 'cui_str': 'LTA'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",41.0,0.234107,"LTA release, LTA-mediated inflammatory responses, clinical outcomes, inflammatory biomarkers and transcription profiles were not different between treatment groups.
","[{'ForeName': 'Geert H', 'Initials': 'GH', 'LastName': 'Groeneveld', 'Affiliation': 'Department of Internal Medicine and Infectious Diseases, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands.'}, {'ForeName': 'Tanny J', 'Initials': 'TJ', 'LastName': 'van der Reyden', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands.'}, {'ForeName': 'Simone A', 'Initials': 'SA', 'LastName': 'Joosten', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands.'}, {'ForeName': 'Hester J', 'Initials': 'HJ', 'LastName': 'Bootsma', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment (Rijksinstituut voor Volksgezondheid en Milieu, RIVM), Bilthoven, The Netherlands.'}, {'ForeName': 'Christa M', 'Initials': 'CM', 'LastName': 'Cobbaert', 'Affiliation': 'Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands.'}, {'ForeName': 'Jutte J C', 'Initials': 'JJC', 'LastName': 'de Vries', 'Affiliation': 'Department of Medical Microbiology, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands.'}, {'ForeName': 'Ed J', 'Initials': 'EJ', 'LastName': 'Kuijper', 'Affiliation': 'Department of Medical Microbiology, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands.'}, {'ForeName': 'Jaap T', 'Initials': 'JT', 'LastName': 'van Dissel', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz207']
559,31106353,Four versus six weeks of antibiotic therapy for osteoarticular infections after implant removal: a randomized trial.,"BACKGROUND


The optimal duration of antibiotic therapy for treating orthopaedic implant infections after surgical drainage and complete implant removal is unknown.
METHODS


This was a single-centre, unblinded, prospective trial randomizing (1:1) eligible patients to either 4 or 6 weeks of systemic, pathogen-targeted antibiotic therapy. Clinical trial registration number: ClinicalTrials.gov (NCT0362209).
RESULTS


We analysed 123 eligible patients (62 in the 4 week antibiotic arm and 61 in the 6 week arm) in the ITT analysis. The patients' median age was 64 years, 75 (61%) were men and 38 (31%) were immunocompromised. The most common types of infection treated included: two-stage exchange procedure for prosthetic joint infection (n = 38); orthopaedic plate infection (44) and infected nail implants (11). The median duration of post-explant intravenous antibiotic therapy was 4 days. Overall, 120 episodes (98%) were cured microbiologically and 116 (94%) clinically after a median follow-up period of 2.2 years. During follow-up, four patients had a clinical recurrence with a pathogen other than the initial causative agent. We noted recurrence of clinical infection in four patients in the 4 week arm and three patients in the 6 week arm (4/62 versus 3/61; χ2 test; P = 0.74); in all cases, this occurred at around 2 months following the end of antibiotic treatment.
CONCLUSIONS


We found no statistically significant difference in the rates of clinical or microbiological remission between patients randomized to only 4 compared with 6 weeks of systemic antibiotic therapy after removal of an infected osteoarticular implant.",2019,We found no statistically significant difference in the rates of clinical or microbiological remission between patients randomized to only 4 compared with 6 weeks of systemic antibiotic therapy after removal of an infected osteoarticular implant.,"['123 eligible patients (62 in the 4\u2009week antibiotic arm and 61 in the 6\u2009week arm) in the ITT analysis', ""patients' median age was 64\u2009years, 75 (61%) were men and 38 (31%) were immunocompromised"", 'eligible patients to either 4 or 6\u2009weeks of systemic, pathogen-targeted antibiotic therapy', 'prosthetic joint infection (n\u205f=\u205f38); orthopaedic plate infection (44) and infected nail implants (11']","['antibiotic therapy', 'systemic antibiotic therapy']","['median duration', 'recurrence of clinical infection', 'rates of clinical or microbiological remission', 'clinical recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0085393', 'cui_str': 'Immunosuppressed Host'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C0410808', 'cui_str': 'Prosthetic joint infection (disorder)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]","[{'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0275521', 'cui_str': 'Clinical infection (disorder)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",123.0,0.238729,We found no statistically significant difference in the rates of clinical or microbiological remission between patients randomized to only 4 compared with 6 weeks of systemic antibiotic therapy after removal of an infected osteoarticular implant.,"[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Benkabouche', 'Affiliation': 'Department of Community Medicine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Racloz', 'Affiliation': 'Orthopaedic Surgery Service, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Spechbach', 'Affiliation': 'Department of Community Medicine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Lipsky', 'Affiliation': 'Service of Infectious Diseases, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Gaspoz', 'Affiliation': 'Department of Community Medicine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Uçkay', 'Affiliation': 'Orthopaedic Surgery Service, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz202']
560,31305186,Guselkumab improves work productivity in patients with moderate-to-severe psoriasis with or without depression and anxiety: results from the VOYAGE 2 comparator study versus adalimumab.,"Purpose:  To evaluate the impact of guselkumab on work productivity, including absenteeism and presenteeism, in psoriasis patients with and without depression/anxiety. Methods:  VOYAGE 2 is a randomized, double-blind, placebo-controlled, and comparator-controlled, phase 3 trial that compared guselkumab with adalimumab in patients with moderate-to-severe psoriasis. Absenteeism was evaluated among patients who reported that their skin prevented work/study based on the Dermatology Life Quality Index (DLQI) work/study domain (score = 3) at baseline. Presenteeism was assessed by summarizing mean changes in four Work Limitations Questionnaire (WLQ) domain scores at week 24. Analyses were compared between treatments and stratified by depression/anxiety status at baseline. Results:  At week 24, 82.1% and 50.0% in the guselkumab and adalimumab groups, respectively, reported a DLQI work/study score = 0 (no effect of skin on work/study) ( p  < .001). Mean changes (improvements) were greater in guselkumab-treated versus adalimumab-treated patients in the work limitations domains of Physical Demands (-6.9 vs. -3.3,  p  < .05), Mental-Interpersonal (-6.3 vs. -3.2,  p  < .06), and Output Demands (-6.2 vs. -2.2,  p  < .05). Improvements were consistent in patients with and without depression/anxiety. Conclusions:  Psoriasis patients treated with guselkumab had significantly better improvements in absenteeism and presenteeism compared with those treated with adalimumab, regardless of depression/anxiety status.",2020,"Conclusions:  Psoriasis patients treated with guselkumab had significantly better improvements in absenteeism and presenteeism compared with those treated with adalimumab, regardless of depression/anxiety status.","['patients with moderate-to-severe psoriasis with or without depression and anxiety', 'psoriasis patients with and without depression/anxiety', 'patients with moderate-to-severe psoriasis']","['guselkumab with adalimumab', 'adalimumab', 'placebo', 'guselkumab', 'Guselkumab']","['Output Demands', 'absenteeism and presenteeism', 'Dermatology Life Quality Index (DLQI) work/study domain', 'Mental-Interpersonal', 'Absenteeism', 'Limitations Questionnaire (WLQ) domain scores', 'work productivity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C4042785', 'cui_str': 'Sickness Presence'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}]",,0.0621237,"Conclusions:  Psoriasis patients treated with guselkumab had significantly better improvements in absenteeism and presenteeism compared with those treated with adalimumab, regardless of depression/anxiety status.","[{'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf and Skinflammation® Center, Hamburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Foley', 'Affiliation': ""St. Vincent's Hospital Melbourne and Skin & Cancer Foundation Inc, The University of Melbourne, Carlton, Australia.""}, {'ForeName': 'Chenglong', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Janssen Research and Development, LLC, Malvern/Horsham, PA, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'McElligott', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Muser', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Janssen Research and Development, LLC, Malvern/Horsham, PA, USA.'}, {'ForeName': 'April W', 'Initials': 'AW', 'LastName': 'Armstrong', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}]",The Journal of dermatological treatment,['10.1080/09546634.2019.1628172']
561,31860537,Single High-dose Vitamin D3 Supplementation in Pediatric Patients With Inflammatory Bowel Disease and Hypovitaminosis D.,"OBJECTIVES


The primary aim was to determine the effectiveness of a single high-dose of oral vitamin D3 (stoss therapy) in children with inflammatory bowel disease (IBD) and hypovitaminosis D. Our secondary aim was to examine the safety of stoss therapy.
METHODS


We conducted a randomized, prospective study of 44 patients, ages 6 to 21 years, with IBD and 25-hydroxyvitamin D (25-OHD) concentrations <30 ng/mL. Patients were randomized to receive 50,000 IU of vitamin D3 once weekly for 6 weeks (standard of care, SOC group) or 300,000 IU once (stoss group). Serum 25-OHD levels were obtained at baseline, 4 and 12 weeks. Safety monitoring labs were performed at week 4.
RESULTS


Thirty-nine of 44 enrolled patients (19 stoss, 20 SOC) completed the study. Baseline vitamin D levels were not significantly different between the groups. Stoss therapy resulted in a substantial rise in 25-OHD levels at week 4, equivalent to the weekly regimen (53.6 ± 17.3 vs 54.6 ± 17.5 ng/mL). At week 12, serum 25-OHD levels decreased in both groups, significantly lower in the stoss group, but remained close to 30 ng/mL (29.8 ± 7.1 vs 40.4 ± 11.9 ng/mL, P = 0.04). A significant interaction with treatment group over time was observed (P = 0.0003). At the week-4 time point, all patients who received stoss therapy had normal serum calcium and PTH levels. Eighty percentage of patients preferred stoss therapy to the weekly regimen.
CONCLUSIONS


Stoss therapy was safe and effective in raising 25-OHD in children with IBD commensurate to that of the weekly regimen.",2020,"At week 12, serum 25-OHD levels decreased in both groups, significantly lower in the stoss group, but remained close to 30 ng/mL (29.8 ± 7.1 ","['children with inflammatory bowel disease (IBD) and hypovitaminosis D', 'children with IBD', 'Pediatric Patients with Inflammatory Bowel Disease and Hypovitaminosis D', 'of forty-four enrolled patients (19 stoss, 20 SOC) completed the study', '44 patients, age 6-21 years, with IBD and 25-hydroxyvitamin D (25-OHD) concentrations < 30ng/mL. Patients', 'Thirty-nine']","['vitamin D3', 'oral vitamin D3 (stoss therapy', 'Single High dose Vitamin D3 Supplementation']","['Serum 25-OHD levels', 'Baseline vitamin D levels', 'normal serum calcium and PTH levels', 'serum 25-OHD levels', '25-OHD levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}]","[{'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}]",44.0,0.185356,"At week 12, serum 25-OHD levels decreased in both groups, significantly lower in the stoss group, but remained close to 30 ng/mL (29.8 ± 7.1 ","[{'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': ""Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Nationwide Children's Hospital.""}, {'ForeName': 'Ross M', 'Initials': 'RM', 'LastName': 'Maltz', 'Affiliation': ""Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Nationwide Children's Hospital.""}, {'ForeName': 'Wallace V', 'Initials': 'WV', 'LastName': 'Crandall', 'Affiliation': ""Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Nationwide Children's Hospital.""}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Plogsted', 'Affiliation': 'Clinical Pharmacy-Nutritional Support Service.'}, {'ForeName': 'Ala K', 'Initials': 'AK', 'LastName': 'Shaikhkhalil', 'Affiliation': ""Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Nationwide Children's Hospital.""}, {'ForeName': 'Sasigarn A', 'Initials': 'SA', 'LastName': 'Bowden', 'Affiliation': 'Department of Pediatrics, The Ohio State University College of Medicine.'}, {'ForeName': 'Ethan A', 'Initials': 'EA', 'LastName': 'Mezoff', 'Affiliation': ""Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Nationwide Children's Hospital.""}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002590']
562,31304887,PTSD Symptom Clusters and Craving Differs by Primary Drug of Choice.,"Objective:  Research has demonstrated a cyclical relationship between posttraumatic stress disorder (PTSD) and substance use disorder. Identifying factors that link PTSD symptom clusters and substance use disorder may illuminate mechanisms underlying the PTSD-substance use disorder relationship, better informing interventions that target this comorbidity. The current study of individuals enrolled in an outpatient aftercare chemical dependency program in King County, Washington, assessed whether overall PTSD symptoms and specific PTSD symptom clusters predicted craving depending on individuals identified primary drug of choice (DOC).  Methods:  Participants eligible for the parent study were at least 18 years of age, fluent in English, medically cleared from substance withdrawal, and able to participate in treatment sessions and agreed to random assignment. Random assignment to either a mindfulness-based relapse prevention group, a standard relapse prevention group, or a treatment as usual group was conducted on a computer randomization program. A secondary analysis of baseline data was employed in the current study to determine which of the PTSD symptom clusters (avoidance, hyperarousal, and intrusion) predicted substance craving.  Results:  Covarying for severity of dependence, results suggest that overall PTSD scores predicted craving in participants who identified alcohol, stimulants, and opiates as their primary DOC. Further, avoidance-related PTSD symptoms alone predicted a significant proportion of the variability in craving in stimulant users, and hyperarousal symptoms alone predicted a significant proportion of the variability in craving in alcohol users. No specific PTSD cluster significantly predicted a proportion of the variability in craving in marijuana or opiates users.  Conclusions:  Findings suggest that craving may play a role in maintaining the relationship between specific PTSD symptom clusters and substance use disorder, and the nature of this relationship may differ by primary DOC. The clinical trial on which this secondary analysis of data was conducted is registered as NCT01159535 at www.clinicaltrials.gov.The original trial from which data for this study was drawn was supported by the National Institutes of Health [NIH/NIDA 5 R01 DA025764-02].",2019,"Random assignment to either a mindfulness-based relapse prevention group, a standard relapse prevention group, or a treatment as usual group was conducted on a computer randomization program.","['individuals enrolled in an outpatient aftercare chemical dependency program in King County, Washington, assessed whether overall PTSD symptoms and specific PTSD symptom clusters predicted craving depending on individuals identified primary drug of choice (DOC', 'Participants eligible for the parent study were at least 18\u2009years of age, fluent in English, medically cleared from substance withdrawal, and able to participate in treatment sessions and agreed to random assignment']",[],"['PTSD symptom clusters (avoidance, hyperarousal, and intrusion) predicted substance craving']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}, {'cui': 'C0011546', 'cui_str': 'Dependency'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0454792', 'cui_str': 'Offaly (geographic location)'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0011710', 'cui_str': 'desoxycortone'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}]",[],"[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}]",,0.0438125,"Random assignment to either a mindfulness-based relapse prevention group, a standard relapse prevention group, or a treatment as usual group was conducted on a computer randomization program.","[{'ForeName': 'Vanessa C', 'Initials': 'VC', 'LastName': 'Somohano', 'Affiliation': 'Graduate Psychology, Pacific University, Hillsboro, Oregon, USA.'}, {'ForeName': 'Kristoffer L', 'Initials': 'KL', 'LastName': 'Rehder', 'Affiliation': 'Graduate Psychology, Pacific University, Hillsboro, Oregon, USA.'}, {'ForeName': 'Tyree', 'Initials': 'T', 'LastName': 'Dingle', 'Affiliation': 'Graduate Psychology, Pacific University, Hillsboro, Oregon, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Shank', 'Affiliation': 'Graduate Psychology, Pacific University, Hillsboro, Oregon, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bowen', 'Affiliation': 'Graduate Psychology, Pacific University, Hillsboro, Oregon, USA.'}]",Journal of dual diagnosis,['10.1080/15504263.2019.1637039']
563,32208397,Safety and Efficacy of Prasugrel in Elderly/Low Body Weight Japanese Patients with Ischemic Stroke: Randomized PRASTRO-II.,"INTRODUCTION


The safety of prasugrel in elderly and/or low body weight Japanese patients with ischemic stroke who have a relatively high bleeding risk with antiplatelet therapy remains unknown.
OBJECTIVE


We aimed to investigate the safety and efficacy of long-term prasugrel monotherapy for stroke prevention compared with clopidogrel in elderly and/or low body weight Japanese patients with non-cardioembolic ischemic stroke.
METHODS


In this randomized, double-blind, comparative, phase III study, elderly (age ≥75 years) and/or low body weight (≤50 kg) Japanese patients with a previous history of non-cardioembolic ischemic stroke were assigned to a prasugrel 3.75 mg (PRA3.75) group, a prasugrel 2.5 mg (PRA2.5) group, or a clopidogrel 50 mg (CLO50) group and followed up for 48 weeks. The primary safety endpoint was the combined incidence of primary safety events, defined as life-threatening, major, and other clinically relevant bleeding. The efficacy endpoint was a composite of ischemic stroke, myocardial infarction, and death from other vascular causes.
RESULTS


A total of 654 patients (age 76.4 ± 7.3 years, body weight 55.6 ± 9.3 kg, women 43.9%) from 74 medical institutions within Japan were enrolled. The combined incidence (95% CI) of primary safety events was 4.2% (1.9-7.8%), 1.9% (0.5-4.7%), and 3.6% (1.6-6.9%) in the PRA3.75 group (n = 216), PRA2.5 group (n = 215), and CLO50 group (n = 223), respectively (hazard ratios [HR] PRA3.75/CLO50, 1.13 [0.44-2.93]; PRA2.5/CLO50, 0.51 [0.15-1.69]). The incidences of bleeding leading to treatment discontinuation (95% CI) were 2.3% (0.8-5.3%), 0.9% (0.1-3.3%), and 2.2% (0.7-5.2%) in the PRA3.75, PRA2.5, and CLO50 groups, respectively (HRs PRA3.75/CLO50, 1.01 [0.29-3.48]; PRA2.5/CLO50, 0.41 [0.08-2.12]). There was no significant difference in all bleeding events between groups. The incidence of ischemic stroke, myocardial infarction, and death from other vascular causes was lower, but not significantly so, in patients treated with prasugrel than in patients treated with clopidogrel: PRA3.75, 0.0% (0/216); PRA2.5, 3.3% (7/215); and CLO50, 3.6% (8/223; HRs PRA3.75/CLO50, 0.00 [0.00-0.00]; PRA2.5/CLO50, 0.90 [0.32-2.47]).
CONCLUSIONS


Elderly and/or low body weight -Japanese patients with previous non-cardioembolic ischemic stroke who received PRA3.75 showed similar results in terms of primary safety endpoint, and a numerically lower incidence of ischemic stroke, myocardial infarction, and death from other vascular causes, compared with those who received CLO50.",2020,"The incidence of ischemic stroke, myocardial infarction, and death from other vascular causes was lower, but not significantly so, in patients treated with prasugrel than in patients treated with clopidogrel: PRA3.75, 0.0% (0/216); PRA2.5, 3.3% (7/215); and CLO50, 3.6% (8/223; HRs PRA3.75/CLO50, 0.00 [0.00-0.00]; PRA2.5/CLO50, 0.90 [0.32-2.47]).
","['Elderly/Low Body Weight Japanese Patients with Ischemic Stroke', '654 patients (age 76.4 ± 7.3 years, body weight 55.6 ± 9.3 kg, women 43.9%) from 74 medical institutions within Japan were enrolled', 'elderly and/or low body weight Japanese patients with non-cardioembolic ischemic stroke', 'elderly and/or low body weight Japanese patients with ischemic stroke who have a relatively high bleeding risk with antiplatelet therapy remains unknown', 'elderly (age ≥75 years) and/or low body weight (≤50 kg) Japanese patients with a previous history of non-cardioembolic ischemic stroke']","['clopidogrel', 'Prasugrel', 'prasugrel 3.75 mg (PRA3.75', 'clopidogrel 50 mg (CLO50', 'PRA3.75', 'prasugrel 2.5\xa0mg (PRA2.5', 'long-term prasugrel monotherapy', 'prasugrel']","['combined incidence of primary safety events, defined as life-threatening, major, and other clinically relevant bleeding', 'Safety and Efficacy', 'composite of ischemic stroke, myocardial infarction, and death from other vascular causes', 'bleeding events', 'incidences of bleeding leading to treatment discontinuation', 'incidence of ischemic stroke, myocardial infarction, and death from other vascular causes', 'ischemic stroke, myocardial infarction, and death', 'safety and efficacy']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C4517697', 'cui_str': 'Three point seven five'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",654.0,0.052672,"The incidence of ischemic stroke, myocardial infarction, and death from other vascular causes was lower, but not significantly so, in patients treated with prasugrel than in patients treated with clopidogrel: PRA3.75, 0.0% (0/216); PRA2.5, 3.3% (7/215); and CLO50, 3.6% (8/223; HRs PRA3.75/CLO50, 0.00 [0.00-0.00]; PRA2.5/CLO50, 0.90 [0.32-2.47]).
","[{'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kitagawa', 'Affiliation': ""Department of Neurology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan, kitagawa.kazuo@twmu.ac.jp.""}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Takanari', 'Initials': 'T', 'LastName': 'Kitazono', 'Affiliation': 'Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Masakatsu', 'Initials': 'M', 'LastName': 'Nishikawa', 'Affiliation': 'Clinical Research Support Center, Mie University Hospital, Mie, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Nanto', 'Affiliation': 'Department of Cardiology, Nishinomiya Municipal Central Hospital, Hyogo, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ikeda', 'Affiliation': 'Waseda University Faculty of Science and Engineering, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Abe', 'Affiliation': 'Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Ogawa', 'Affiliation': 'Department of Neurosurgery, Iwate Medical University, Iwate, Japan.'}]","Cerebrovascular diseases (Basel, Switzerland)",['10.1159/000506825']
564,32084522,Phase I Trial of MRI-Guided Prostate Cancer Lattice Extreme Ablative Dose (LEAD) Boost Radiation Therapy.,"PURPOSE


A phase I clinical trial was designed to test the feasibility and toxicity of administering high-dose spatially fractionated radiation therapy to magnetic resonance imaging (MRI)-defined prostate tumor volumes, in addition to standard treatment.
METHODS AND MATERIALS


We enrolled 25 men with favorable to high-risk prostate cancer and 1 to 3 suspicious multiparametric MRI (mpMRI) gross tumor volumes (GTVs). The mpMRI-GTVs were treated on day 1 with 12 to 14 Gy via dose cylinders using a lattice extreme ablative dose technique. The entire prostate, along with the proximal seminal vesicles, was then treated to 76 Gy at 2 Gy/fraction. For some high-risk patients, the distal seminal vesicles and pelvic lymph nodes received 56 Gy at 1.47 Gy/fraction concurrently in 38 fractions. The total dose to the lattice extreme ablative dose cylinder volume(s) was 88 to 90 Gy (112-123 Gy in 2.0 Gy equivalents, assuming an α-to-β ratio of 3).
RESULTS


Dosimetric parameters were satisfactorily met. Median follow-up was 66 months. There were no grade 3 acute/subacute genitourinary or gastrointestinal adverse events. Maximum late genitourinary toxicity was grade 1 in 15 (60%), grade 2 in 4 (16%), and grade 4 in 1 (4%; sepsis after a posttreatment transurethral resection). Maximum late gastrointestinal toxicity was grade 1 in 11 (44%) and grade 2 in 4 (16%). Two patients experienced biochemical failure.
CONCLUSIONS


External beam radiation therapy delivered with an upfront spatially fractionated, stereotactic high-dose mpMRI-GTV boost is feasible and was not associated with any unexpected events. The technique is now part of a follow-up phase II randomized trial.",2020,"Maximum late GU toxicity was Grade 1 in 15 (60%), Grade 2 in 4 (16%), and Grade 4 in 1 (4%; sepsis after a post-treatment transurethral resection).",['We enrolled 25 men with favorable to high-risk prostate cancer and 1-3 suspicious multiparametric MRI (mpMRI) gross tumor volumes (GTVs'],"['MRI-GUIDED Prostate Cancer Lattice Extreme Ablative Dose (LEAD', 'BOOST Radiotherapy', 'Lattice Extreme Ablative Dose (LEAD) technique', 'PHASE']","['biochemical failure', 'grade 3 acute/subacute genitourinary (GU) or gastrointestinal (GI) adverse events', 'Maximum late GU toxicity', 'feasibility and toxicity', 'Maximum late GI toxicity']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0475645', 'cui_str': 'Gross tumor volume (observable entity)'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",25.0,0.038764,"Maximum late GU toxicity was Grade 1 in 15 (60%), Grade 2 in 4 (16%), and Grade 4 in 1 (4%; sepsis after a post-treatment transurethral resection).","[{'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Pollack', 'Affiliation': 'Departments of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida. Electronic address: apollack@med.miami.edu.'}, {'ForeName': 'Felix M', 'Initials': 'FM', 'LastName': 'Chinea', 'Affiliation': 'Departments of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bossart', 'Affiliation': 'Departments of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Deukwoo', 'Initials': 'D', 'LastName': 'Kwon', 'Affiliation': 'Departments of Public Health Sciences and Biostatistics and Bioinformatics Shared Resource, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Abramowitz', 'Affiliation': 'Departments of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lynne', 'Affiliation': 'Departments of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Merce', 'Initials': 'M', 'LastName': 'Jorda', 'Affiliation': 'Departments of Pathology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Marples', 'Affiliation': 'Departments of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Vivek N', 'Initials': 'VN', 'LastName': 'Patel', 'Affiliation': 'Departments of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Biophysics Research Institute of America, Miami, Florida.'}, {'ForeName': 'Isildinha', 'Initials': 'I', 'LastName': 'Reis', 'Affiliation': 'Departments of Public Health Sciences and Biostatistics and Bioinformatics Shared Resource, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Studenski', 'Affiliation': 'Departments of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Casillas', 'Affiliation': 'Department of Radiology, University of Miami, Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Radka', 'Initials': 'R', 'LastName': 'Stoyanova', 'Affiliation': 'Departments of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.01.052']
565,31294589,Intensive group behavioral treatment (IGBT) for children with selective mutism: A preliminary randomized clinical trial.,"OBJECTIVE


Very few controlled trials have evaluated targeted treatment methods for childhood selective mutism (SM); the availability of evidence-based services remains limited. This study is the first controlled trial to evaluate an intensive group behavioral treatment (IGBT) for children with SM.
METHOD


Twenty-nine children with SM (5-9 years; 76% female; 35% ethnic minority) were randomized to immediate SM 5-day IGBT or to a 4-week waitlist with psychoeducational resources (WLP), and were assessed at Week 4 and again 8 weeks into the following school year.
RESULTS


IGBT was associated with high satisfaction and low perceived barriers to treatment participation. At Week 4, 50% of the immediate IGBT condition and 0% of the WLP condition were classified as ""clinical responders."" Further, Time × Condition interactions were significant for social anxiety severity, verbal behavior in social situations, and global functioning (but not for SM severity, verbal behavior in home settings, or overall anxiety). School-year follow-up assessments revealed significant improvements across all outcomes. Eight weeks into the following school year, 46% of IGBT-treated children were free of an SM diagnosis. In addition, teachers in the post-IGBT school year rated less school impairment and more classroom verbal behavior relative to teachers in the pre-IGBT school year.
CONCLUSIONS


Findings provide the first empirical support for the efficacy and acceptability of IGBT for SM. Further study is needed to examine mechanisms of IGBT response, and other effective SM treatment methods, in order to clarify which treatment formats work best for which affected children. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,School-year follow-up assessments revealed significant improvements across all outcomes.,"['children with SM', 'children with selective mutism', 'Twenty-nine children with SM (5-9 years; 76% female; 35% ethnic minority']","['Intensive group behavioral treatment (IGBT', 'immediate SM 5-day IGBT or to a 4-week waitlist with psychoeducational resources (WLP', 'intensive group behavioral treatment (IGBT']","['classroom verbal behavior', 'social anxiety severity, verbal behavior in social situations, and global functioning', 'SM severity, verbal behavior in home settings, or overall anxiety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0236818', 'cui_str': 'Selective Mutism'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0042530', 'cui_str': 'Verbal Behavior'}, {'cui': 'C0424166', 'cui_str': 'Social Anxiety'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",29.0,0.0495299,School-year follow-up assessments revealed significant improvements across all outcomes.,"[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Cornacchio', 'Affiliation': 'Center for Children and Families, Mental Health Interventions and Technology (MINT) Program, Department of Psychology, Florida International University.'}, {'ForeName': 'Jami M', 'Initials': 'JM', 'LastName': 'Furr', 'Affiliation': 'Center for Children and Families, Mental Health Interventions and Technology (MINT) Program, Department of Psychology, Florida International University.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Sanchez', 'Affiliation': 'Center for Children and Families, Mental Health Interventions and Technology (MINT) Program, Department of Psychology, Florida International University.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Hong', 'Affiliation': 'Center for Children and Families, Mental Health Interventions and Technology (MINT) Program, Department of Psychology, Florida International University.'}, {'ForeName': 'Leah K', 'Initials': 'LK', 'LastName': 'Feinberg', 'Affiliation': 'Center for Children and Families, Mental Health Interventions and Technology (MINT) Program, Department of Psychology, Florida International University.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Tenenbaum', 'Affiliation': 'Center for Children and Families, Mental Health Interventions and Technology (MINT) Program, Department of Psychology, Florida International University.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Del Busto', 'Affiliation': 'Center for Children and Families, Mental Health Interventions and Technology (MINT) Program, Department of Psychology, Florida International University.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Bry', 'Affiliation': 'Center for Children and Families, Mental Health Interventions and Technology (MINT) Program, Department of Psychology, Florida International University.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Poznanski', 'Affiliation': 'Center for Children and Families, Mental Health Interventions and Technology (MINT) Program, Department of Psychology, Florida International University.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miguel', 'Affiliation': 'Center for Children and Families, Mental Health Interventions and Technology (MINT) Program, Department of Psychology, Florida International University.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Ollendick', 'Affiliation': 'Department of Psychology, Virginia Tech.'}, {'ForeName': 'Steven M S', 'Initials': 'SMS', 'LastName': 'Kurtz', 'Affiliation': 'Private Practice.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Comer', 'Affiliation': 'Center for Children and Families, Mental Health Interventions and Technology (MINT) Program, Department of Psychology, Florida International University.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000422']
566,31838642,Myostatin as a potential biomarker to monitor sarcopenia in hip fracture patients undergoing a multidisciplinary rehabilitation and nutritional treatment: a preliminary study.,"Hip fractures are the most common osteoporotic fractures related to disability in older adults, requiring surgery and a subsequent rehabilitation treatment. Sarcopenia is currently considered as a predictive of worse outcome in hip fracture patients and myostatin has been recently proposed a potential biomarker of this condition. Twenty hip fracture patients after total hip replacement (mean aged 75.9 ± 2.4 years) were randomly divided into two groups of ten subjects (groups A and B). Both groups performed a rehabilitation program (5 sessions of 40 min/week for 2 weeks, followed by home-based exercise protocol). Group A received also 2-month amino acid supplementation. Serum myostatin levels significantly decreased after 2 months in both group A (p = 0.01) and group B (p = 0.03) in sarcopenic patients only in group A (p = 0.04). These results suggest that myostatin might be considered a promising biomarker of sarcopenia in hip fracture older adults' patients undergoing rehabilitation and amino acid supplementation.",2020,Serum myostatin levels significantly decreased after 2 months in both group A (p = 0.01) and group B (p = 0.03) in sarcopenic patients only in group A (p = 0.04).,"['hip fracture patients', 'Twenty hip fracture patients after total hip replacement (mean aged 75.9\u2009±\u20092.4\xa0years', 'hip fracture patients undergoing a', ""hip fracture older adults' patients undergoing rehabilitation and amino acid supplementation""]","['rehabilitation program', 'multidisciplinary rehabilitation and nutritional treatment', 'amino acid supplementation', 'Myostatin']",['Serum myostatin levels'],"[{'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040508', 'cui_str': 'Hip Replacement, Total'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C1457899', 'cui_str': 'GDF-8'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1457899', 'cui_str': 'GDF-8'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",20.0,0.0136437,Serum myostatin levels significantly decreased after 2 months in both group A (p = 0.01) and group B (p = 0.03) in sarcopenic patients only in group A (p = 0.04).,"[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'de Sire', 'Affiliation': 'Physical and Rehabilitative Medicine, Department of Health Sciences, University of Eastern Piedmont ""A. Avogadro"", Viale Piazza D\'Armi, 1, 28100, Novara, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Baricich', 'Affiliation': 'Physical and Rehabilitative Medicine, Department of Health Sciences, University of Eastern Piedmont ""A. Avogadro"", Viale Piazza D\'Armi, 1, 28100, Novara, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Renò', 'Affiliation': 'Innovative Research Laboratory for Wound Healing, Department of Health Sciences, University of Eastern Piedmont ""A. Avogadro"", Novara, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Cisari', 'Affiliation': 'Physical and Rehabilitative Medicine, Department of Health Sciences, University of Eastern Piedmont ""A. Avogadro"", Viale Piazza D\'Armi, 1, 28100, Novara, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Fusco', 'Affiliation': 'Division of Pathology, IEO-European Institute of Oncology IRCCS, University of Milan, Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Invernizzi', 'Affiliation': 'Physical and Rehabilitative Medicine, Department of Health Sciences, University of Eastern Piedmont ""A. Avogadro"", Viale Piazza D\'Armi, 1, 28100, Novara, Italy. marco.invernizzi@med.uniupo.it.'}]",Aging clinical and experimental research,['10.1007/s40520-019-01436-8']
567,31298266,Rhythm control for patients with atrial fibrillation complicated with heart failure in the contemporary era of catheter ablation: a stratified pooled analysis of randomized data.,"AIMS


The optimal treatment for patients with atrial fibrillation (AF) and heart failure (HF) has been a subject of debate for years. We aimed to evaluate the efficacy and safety of rhythm control strategy in patients with AF complicated with HF regarding hard clinical endpoints.
METHODS AND RESULTS


Up-to-date randomized data comparing rhythm control using antiarrhythmic drugs (AADs) vs. rate control (Subset A) or rhythm control using catheter ablation vs. medical therapy (Subset B) in AF and HF patients were pooled. The primary outcomes were all-cause mortality, re-hospitalization, stroke, and thromboembolic events. A total of 11 studies involving 3598 patients were enrolled (Subset A: 2486; Subset B: 1112). As compared with medical rate control, the AADs rhythm control was associated with similar all-cause mortality [odds ratio (OR): 0.96, P = 0.65], significantly higher rate of re-hospitalization (OR: 1.25, P = 0.01), and similar rate of stroke and thromboembolic events (OR: 0.91, P = 0.76,); however, as compared with medical therapy, catheter ablation rhythm control was associated with significantly lower all-cause mortality (OR: 0.51, P = 0.0003), reduced re-hospitalization rate (OR: 0.44, P = 0.003), similar rate of stroke events (OR: 0.59, P = 0.27), greater improvement in left ventricular ejection fraction [weighted mean difference (WMD): 6.8%, P = 0.0004], lower arrhythmia recurrence (29.6% vs. 80.1%, OR: 0.04, P < 0.00001), and greater improvement in quality of life (Minnesota Living with Heart Failure Questionnaire score) (WMD: -9.1, P = 0.007).
CONCLUSION


Catheter ablation as rhythm control strategy substantially improves survival rate, reduces re-hospitalization, increases the maintenance rate of sinus rhythm, contributes to preserve cardiac function, and improves quality of life for AF patients complicated with HF.",2020,"As compared with medical rate control, the AADs rhythm control was associated with similar all-cause mortality [odds ratio (OR): 0.96, P = 0.65], significantly higher rate of re-hospitalization (OR: 1.25, P = 0.01), and similar rate of stroke and thromboembolic events (OR: 0.91, P = 0.76,); however, as compared with medical therapy, catheter ablation rhythm control was associated with significantly lower all-cause mortality (OR: 0.51, P = 0.0003), reduced re-hospitalization rate (OR: 0.44, P = 0.003), similar rate of stroke events (OR: 0.59, P = 0.27), greater improvement in left ventricular ejection fraction [weighted mean difference (WMD): 6.8%, P = 0.0004], lower arrhythmia recurrence (29.6% vs. 80.1%, OR: 0.04, P < 0.00001), and greater improvement in quality of life (Minnesota Living with Heart Failure Questionnaire score) (WMD: -9.1, P = 0.007).
","['patients with AF complicated with HF regarding hard clinical endpoints', 'patients with atrial fibrillation (AF) and heart failure (HF', 'A total of 11 studies involving 3598 patients were enrolled ', 'patients with atrial fibrillation complicated with heart failure in the contemporary era of catheter ablation']","['rhythm control using antiarrhythmic drugs (AADs) vs. rate control (Subset A) or rhythm control using catheter ablation vs. medical therapy (Subset B', 'Catheter ablation']","['rate of stroke events', 'reduced re-hospitalization rate', 'left ventricular ejection fraction', 'survival rate, reduces re-hospitalization', 'cause mortality, re-hospitalization, stroke, and thromboembolic events', 'quality of life', 'rate of stroke and thromboembolic events', 'efficacy and safety', 'quality of life (Minnesota Living with Heart Failure Questionnaire score', 'rate of re-hospitalization', 'lower arrhythmia recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0003195', 'cui_str': 'Anti-Arrhythmics'}, {'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0034380'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0003811', 'cui_str': 'Arrhythmia'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",3598.0,0.05714,"As compared with medical rate control, the AADs rhythm control was associated with similar all-cause mortality [odds ratio (OR): 0.96, P = 0.65], significantly higher rate of re-hospitalization (OR: 1.25, P = 0.01), and similar rate of stroke and thromboembolic events (OR: 0.91, P = 0.76,); however, as compared with medical therapy, catheter ablation rhythm control was associated with significantly lower all-cause mortality (OR: 0.51, P = 0.0003), reduced re-hospitalization rate (OR: 0.44, P = 0.003), similar rate of stroke events (OR: 0.59, P = 0.27), greater improvement in left ventricular ejection fraction [weighted mean difference (WMD): 6.8%, P = 0.0004], lower arrhythmia recurrence (29.6% vs. 80.1%, OR: 0.04, P < 0.00001), and greater improvement in quality of life (Minnesota Living with Heart Failure Questionnaire score) (WMD: -9.1, P = 0.007).
","[{'ForeName': 'Shaojie', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Frankfurt Academy For Arrhythmias (FAFA), Cardioangiologisches Centrum Bethanien (CCB) Frankfurt am Main, Medizinische Klinik III, Agaplesion Markus Krankenhaus, Wilhelm-Epstein Straße 4, Frankfurt am Main 60431, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Pürerfellner', 'Affiliation': 'Department für Elektrophysiologie, Akademisches Lehrkrankenhaus, Ordensklinikum Linz Elisabethinen, Linz, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Meyer', 'Affiliation': 'Klinik für Kardiologie mit Schwerpunkt Elektrophysiologie, Universitäres Herzzentrum Hamburg, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Willem-Jan', 'Initials': 'WJ', 'LastName': 'Acou', 'Affiliation': 'Department of Cardiology, AZ Delta, Roeselare, Belgium.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Schratter', 'Affiliation': 'Medizinische Abteilung mit Kardiologie, Krankenhaus Hietzing Wien, Vienna, Austria.'}, {'ForeName': 'Zhiyu', 'Initials': 'Z', 'LastName': 'Ling', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing Cardiac Arrhythmia Service Center, Chongqing, China.'}, {'ForeName': 'Shaowen', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yuehui', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing Cardiac Arrhythmia Service Center, Chongqing, China.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Martinek', 'Affiliation': 'Department für Elektrophysiologie, Akademisches Lehrkrankenhaus, Ordensklinikum Linz Elisabethinen, Linz, Austria.'}, {'ForeName': 'Marcio G', 'Initials': 'MG', 'LastName': 'Kiuchi', 'Affiliation': 'School of Medicine-Royal Perth Hospital Unit, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Schmidt', 'Affiliation': 'Frankfurt Academy For Arrhythmias (FAFA), Cardioangiologisches Centrum Bethanien (CCB) Frankfurt am Main, Medizinische Klinik III, Agaplesion Markus Krankenhaus, Wilhelm-Epstein Straße 4, Frankfurt am Main 60431, Germany.'}, {'ForeName': 'K R Julian', 'Initials': 'KRJ', 'LastName': 'Chun', 'Affiliation': 'Frankfurt Academy For Arrhythmias (FAFA), Cardioangiologisches Centrum Bethanien (CCB) Frankfurt am Main, Medizinische Klinik III, Agaplesion Markus Krankenhaus, Wilhelm-Epstein Straße 4, Frankfurt am Main 60431, Germany.'}]",European heart journal,['10.1093/eurheartj/ehz443']
568,27909178,No Differences in Health Outcomes After Routine Inquiry About Violence Victimization in Young Women: A Randomized Controlled Study in Swedish Youth Health Centers.,"Youth is a period in life when the risk of violence victimization is high and association between victimization and ill health is well established. Youth rarely reveal violence victimization to health professionals if not directly asked but favor health professionals asking about victimization. The study's primary aim was to examine health outcomes in young women being routinely asked about violence victimization and offered subsequent support, compared with controls, at 12-month follow-up. Secondary aims were to examine to what extent routine inquiry altered the consultation and re-victimization rates during the study period. A randomized controlled intervention study was conducted at Swedish youth health centers. Participants assigned to the intervention group were asked structured questions about violence. Victimized participants received empowering strategies and were offered further counseling. Participants in the control group completed questionnaires about victimization after the visit. Both groups answered questions about sociodemographics and health, constructed from validated instruments. A questionnaire was administered to all participants 12 months after baseline. Of 1,445 eligible young women, 1,051 (73%) participated, with 54% of the participants completing the 12-month follow-up. Lifetime violence victimization was reported by 53% in the intervention group and 60% in the control group, ns. There were no significant differences in health outcomes, between baseline and 12-month follow-up, within either group or between groups. Re-victimization rates were 16% in the intervention group and 12% in the control group, ns. Of victimized young women in the intervention group, 14% wanted and received further counseling. Routine inquiry about violence victimization and empowering strategies were feasible within ordinary consultations at youth health centers but did not demonstrate improved health outcomes at 12-month follow-up compared with controls. Questions about violence led to a high degree of disclosure, and 14% of victimized young women in the intervention group received further counseling as a result.",2020,"There were no significant differences in health outcomes, between baseline and 12-month follow-up, within either group or between groups. Re-victimization rates were 16% in the intervention group and 12% in the control group, ns.","['Swedish youth health centers', '1,445 eligible young women, 1,051 (73%) participated, with 54% of the participants completing the 12-month follow-up', 'young women being routinely asked about violence victimization and offered subsequent support, compared with controls, at 12-month follow-up', 'Swedish Youth Health Centers', 'Young Women']",[],"['Re-victimization rates', 'Lifetime violence victimization', 'Health Outcomes', 'health outcomes']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",1445.0,0.0458545,"There were no significant differences in health outcomes, between baseline and 12-month follow-up, within either group or between groups. Re-victimization rates were 16% in the intervention group and 12% in the control group, ns.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Palm', 'Affiliation': 'Uppsala University, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Högberg', 'Affiliation': 'Uppsala University, Sweden.'}, {'ForeName': 'Niclas', 'Initials': 'N', 'LastName': 'Olofsson', 'Affiliation': 'Mid Sweden University, Sundsvall, Sweden.'}, {'ForeName': 'Alkistis', 'Initials': 'A', 'LastName': 'Skalkidou', 'Affiliation': 'Uppsala University, Sweden.'}, {'ForeName': 'Ingela', 'Initials': 'I', 'LastName': 'Danielsson', 'Affiliation': 'Umeå University, Sweden.'}]",Journal of interpersonal violence,['10.1177/0886260516681878']
569,29948858,Beneficial effects of adaptive servo-ventilation on natriuretic peptides and diastolic function in acute heart failure patients with preserved ejection fraction and sleep-disordered breathing.,"PURPOSE


Adaptive servo-ventilation (ASV) is a ventilator algorithm able to correct breathing through anticyclic support of breathing in patients with central sleep apnea (CSA). So far, very few data exist regarding the role of ASV on acute heart failure with preserved ejection fraction (HFpEF).
METHODS


We performed a single-center prospective, randomized, case-control study in consecutive acute HFpEF (left ventricle ejection fraction, LVEF ≥ 45%) patients with sleep-disordered breathing (SDB, apnea-hypopnea index, AHI > 15/h) and prevalence of CSA.
RESULTS


We included ten consecutive patients randomized for ASV on top of standard therapy for acute heart failure (group 1) versus standard care alone (group 2). ASV therapy significantly reduced AHI and CSA. An improvement in cardiac diastolic function was seen in group 1 compared to group 2 (E/E' 17.5 to 9.6, p < 0.02 vs 18.5 to 14.5, p = 0.4). Brain natriuretic peptide (BNP) markedly decreased in cases, but not in controls (298 to 84 pg/ml, p < 0.02 vs 280 to 120 pg/ml, p = 0.06). Right ventricle (RV) function significantly improved in group 1, differently from group 2.
CONCLUSIONS


An acute use of ASV seems effective in reducing BNP and improving diastolic and RV function in acute HFpEF patients with SDB and CSA, compared to standard treatment.",2019,"An improvement in cardiac diastolic function was seen in group 1 compared to group 2 (E/E' 17.5 to 9.6, p < 0.02 vs 18.5 to 14.5, p = 0.4).","['acute heart failure patients with preserved ejection fraction and sleep-disordered breathing', 'consecutive acute HFpEF', 'patients with SDB and CSA', 'patients with central sleep apnea (CSA', 'acute HFpEF']","['ASV', 'standard care alone', 'adaptive servo-ventilation', 'Adaptive servo-ventilation (ASV', 'ASV therapy']","['sleep-disordered breathing (SDB, apnea-hypopnea index, AHI >\u200915/h) and prevalence of CSA', 'Brain natriuretic peptide (BNP', 'AHI and CSA', 'natriuretic peptides and diastolic function', 'cardiac diastolic function', 'BNP and improving diastolic and RV function', 'Right ventricle (RV) function']","[{'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C3887547', 'cui_str': 'Central sleep apnea syndrome (disorder)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4285752', 'cui_str': 'Adaptive support ventilation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0225883', 'cui_str': 'Right Ventricle'}]",10.0,0.028878,"An improvement in cardiac diastolic function was seen in group 1 compared to group 2 (E/E' 17.5 to 9.6, p < 0.02 vs 18.5 to 14.5, p = 0.4).","[{'ForeName': 'E', 'Initials': 'E', 'LastName': ""D'Elia"", 'Affiliation': 'Cardiology Division, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ferrero', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Vittori', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Iacovoni', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Grosu', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gori', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Duino', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Perlini', 'Affiliation': 'Clinica Medica 2 Internal Medicine Department IRCCS San Matteo, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Senni', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy. msenni@asst-pg23.it.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-018-1681-z']
570,29951886,Metoprolol has a similar therapeutic effect as amlodipine on BP lowering in hypertensive patients with obstructive sleep apnea.,"PURPOSE


β-Blocker use has been controversial for a long time in the management of hypertensive patients with obstructive sleep apnea (OSA). The aim of present study was to compare the effects of metoprolol on BP lowering with amlodipine in hypertensive OSA patients.
METHODS


Hypertensive subjects with OSA were randomly assigned to metoprolol and amlodipine groups, receiving 12 weeks of oral either metoprolol (47.5 mg once daily) or amlodipine (5 mg once daily) treatment. At baseline and after the 12-week treatment period, 24-h ambulatory blood pressure monitoring was performed in both groups.
RESULTS


Both of metoprolol and amlodipine treatments significantly lowered 24-h blood pressure (BP) (from 143/88 to 132.3/81.6 mmHg; from 141.3/84.5 to 133.7/80.8 mmHg), daytime BP (from 146/90.2 to 136.4/84.6 mmHg; from 145.1/87.6 to 138.2/84.1 mmHg), and nighttime BP (from 139.1/83.9 to 125.7/76.2 mmHg; from 134.5/78.5 to 125.8/74.1 mmHg) (all P < 0.05). But there were no significant differences between the groups in BP variability (P > 0.05). Besides, metoprolol significantly reduced daytime heart rate (HR) (P < 0.05), while 24-h and nighttime HR values had no remarkable changes compared with baseline (P > 0.05).
CONCLUSIONS


Metoprolol had similar therapeutic effects on BP lowering as amlodipine and could not decrease HR during the nighttime in hypertensive patients with OSA.",2019,"Besides, metoprolol significantly reduced daytime heart rate (HR) (P < 0.05), while 24-h and nighttime HR values had no remarkable changes compared with baseline (P > 0.05).
","['hypertensive patients with OSA', 'hypertensive patients with obstructive sleep apnea', 'hypertensive patients with obstructive sleep apnea (OSA', 'hypertensive OSA patients', 'Hypertensive subjects with OSA']","['amlodipine', 'Metoprolol', 'metoprolol and amlodipine', 'metoprolol']","['24-h blood pressure (BP', '24-h ambulatory blood pressure monitoring', 'BP lowering', '24-h and nighttime HR values', 'BP variability', 'daytime heart rate (HR', 'nighttime BP', 'daytime BP']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C4301622', 'cui_str': 'metoprolol and amlodipine'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0242876', 'cui_str': 'Blood Pressure Monitoring, Ambulatory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",,0.0131591,"Besides, metoprolol significantly reduced daytime heart rate (HR) (P < 0.05), while 24-h and nighttime HR values had no remarkable changes compared with baseline (P > 0.05).
","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Xianzhu', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Yujiao', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Meijiao', 'Initials': 'M', 'LastName': 'He', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Guangzhong', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Danghui', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Jiayu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Wennan', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China. ly99ly@vip.163.com.""}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-018-1688-5']
571,31282402,"Effects of Tai Chi versus Taekkyon on balance, lower-extremity strength, and gait ability in community-dwelling older women: A single-blinded randomized clinical trial.","BACKGROUND


Taekkyon, a Korean form of martial arts, has been trained for a long period. However, it is not yet known whether the Taekkyon exercise has better effects on functional mobility or balance in older adults than other types of well-investigated exercise programs such as Tai Chi (TC).
OBJECTIVE


This study aimed to compare the effects of TC and Taekkyon exercise programs on the lower-extremity strength, balance, and gait ability of community-dwelling older women as a fall prevention method.
METHODS


Community-dwelling older women were randomly allocated into the TC group (n1= 23) and the Taekkyon group (n2= 23). Both groups completed 1 h of either TC or Taekkyon exercises twice weekly for 12 consecutive weeks (24 sessions in total). We measured the Timed Up and Go test (TUG), Functional Reach test (FR), one-leg standing test (OLS), Five Times Sit-to-Stand test (5 × STS), 30 Second Sit-to-Stand test (30 s STS), and spatiotemporal gait parameters (gait velocity, step length, step width, stride time, and cadence) before and after the intervention.
RESULTS


Both groups similarly showed statistically significant improvements in balance (TUG, FR, and OLS), lower-extremity strength (5 × STS and 30 s STS), and spatiotemporal gait parameters except for step width (P< 0.05). Moreover, the TC group showed greater improvement in the OLS test than the Taekkyon group (P< 0.05).
CONCLUSIONS


The results from this study support the efficacy of the TC and Taekkyon exercise programs at improving mobility in this population of older women. However, this study did not clarify which exercise program is more effective as general balance and mobility training program for older women.",2020,"Both groups similarly showed statistically significant improvements in balance (TUG, FR, and OLS), lower-extremity strength (5 × STS and 30 s STS), and spatiotemporal gait parameters except for step width (P< 0.05).","['Community-dwelling older women', 'older women', 'community-dwelling older women', 'older adults']","['Tai Chi versus Taekkyon', 'Taekkyon exercise', 'TC', 'TC or Taekkyon exercises', 'exercise program', 'TC and Taekkyon exercise programs', 'Taekkyon']","['lower-extremity strength, balance, and gait ability', 'balance, lower-extremity strength, and gait ability', 'balance (TUG, FR, and OLS), lower-extremity strength', 'spatiotemporal gait parameters except for step width', 'Timed Up and Go test (TUG), Functional Reach test (FR), one-leg standing test (OLS), Five Times Sit-to-Stand test (5 × STS), 30 Second Sit-to-Stand test (30\xa0s STS), and spatiotemporal gait parameters (gait velocity, step length, step width, stride time, and cadence', 'functional mobility or balance', 'OLS test']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332300', 'cui_str': 'Except for (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test (procedure)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0427126', 'cui_str': 'Step length (observable entity)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}]",,0.0231744,"Both groups similarly showed statistically significant improvements in balance (TUG, FR, and OLS), lower-extremity strength (5 × STS and 30 s STS), and spatiotemporal gait parameters except for step width (P< 0.05).","[{'ForeName': 'Chang-Yong', 'Initials': 'CY', 'LastName': 'Kim', 'Affiliation': 'Pharma & Bio Pharma Industry Team, Department of Pharmaceutical and Bio-Pharmaceutical Industry, Korea Health Industry Development Institute, Chungbuk, Korea.'}, {'ForeName': 'Hyun-Dong', 'Initials': 'HD', 'LastName': 'Je', 'Affiliation': 'Department of Pharmacology, College of Pharmacy, Catholic University of Daegu, Gyeongbuk, Korea.'}, {'ForeName': 'Hyewon', 'Initials': 'H', 'LastName': 'Jeong', 'Affiliation': 'Department of Physical Therapy and School of Health and Environmental Science, College of Health Science, Korea University, Seoul, Korea.'}, {'ForeName': 'Ji-Hoon', 'Initials': 'JH', 'LastName': 'Jeong', 'Affiliation': 'Department of Pharmacology, College of Medicine, Chung-Ang University, Seoul, Korea.'}, {'ForeName': 'Hyeong-Dong', 'Initials': 'HD', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy and School of Health and Environmental Science, College of Health Science, Korea University, Seoul, Korea.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181493']
572,31837906,"Does intramuscular ondansetron have an effect on intramuscular ketamine-associated vomiting in children? A prospective, randomized, double blind, controlled study.","OBJECTIVE


This study was conducted to determine the effect of intramuscular ondansetron on ketamine-associated vomiting in children undergoing procedural sedation.
METHODS


This randomized, double-blind, placebo-controlled, parallel-group clinical trial was conducted at the emergency departments of two university-affiliated tertiary care hospitals. Eligible participants included all 6-month to 16-year-old children who received IM ketamine for PSA in the ED. A convenience sampling approach was used and a block randomization method was applied (blocks of four) using a computer-generated random sequence. Patients received ketamine 4 mg/kg or ketamine 4 mg/kg plus ondansetron 0.1 mg/kg intramuscularly. All findings including the occurrence of vomiting and its frequency were then recorded in the data collection sheets.
RESULTS


Of 56 patients who received ondansetron plus ketamin, 7 (12.5%) and 1 (1.8%) experienced vomiting during recovery and before discharge and Of 65 patients in the control group, 14 (21.5%) and 6 (9.2%) experienced vomiting during recovery and before discharge, respectively. The observed differences in the rates of vomiting during recovery and at discharge were statistically significant between the two groups (P-value of 0.03 and <0.001, respectively).
CONCLUSION


Intramuscular ondansetron is effective in controlling ketamine-associated vomiting.",2020,"The observed differences in the rates of vomiting during recovery and at discharge were statistically significant between the two groups (P-value of 0.03 and <0.001, respectively).
","['children undergoing procedural sedation', 'emergency departments of two university-affiliated tertiary care hospitals', 'Eligible participants included all 6-month to 16-year-old children who received']","['placebo', 'ketamine', 'IM ketamine', 'Intramuscular ondansetron', 'ketamine 4\u202fmg/kg or ketamine 4\u202fmg/kg plus ondansetron 0.1\u202fmg/kg intramuscularly', 'ondansetron', 'ondansetron plus ketamin']","['vomiting', 'occurrence of vomiting and its frequency', 'rates of vomiting']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",65.0,0.545507,"The observed differences in the rates of vomiting during recovery and at discharge were statistically significant between the two groups (P-value of 0.03 and <0.001, respectively).
","[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Nejati', 'Affiliation': 'Department of Emergency Medicine, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: anejati@tumsac.ir.'}, {'ForeName': 'Seyyedhossein Seyyedhoseini', 'Initials': 'SS', 'LastName': 'Davarani', 'Affiliation': 'Department of Emergency Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Taghi', 'Initials': 'MT', 'LastName': 'Talebian', 'Affiliation': 'Department of Emergency Medicine, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: mtalebian@tums.ac.ir.'}, {'ForeName': 'Firouzi', 'Initials': 'F', 'LastName': 'Hossein', 'Affiliation': 'Department of Paediatrics, Ramsar Campus, Mazandaran University of Medical Science, Mazandaran, Iran. Electronic address: firoozihosein@mazums.ac.ir.'}, {'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Akbari', 'Affiliation': 'Department of Emergency Medicine, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: H-akbari@sina.tums.ac.ir.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.158445']
573,31281988,"Efficacy, Safety, and Tolerability of ONO-4474, an Orally Available Pan-Tropomyosin Receptor Kinase Inhibitor, in Japanese Patients With Moderate to Severe Osteoarthritis of the Knee: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Study.","We examined the efficacy, safety, and tolerability of ONO-4474 in Japanese patients with osteoarthritis (OA) of the knee. In this multicenter, placebo-controlled, randomized, double-blind, parallel-group comparative study, patients with moderate to severe OA who were refractory to nonsteroidal anti-inflammatory drugs were orally administered 100 mg of ONO-4474 twice daily for 28 days. The primary end point was knee pain during walking, assessed by visual analog scale over 24 hours (VAS 24  ). Treatment-emergent adverse events (TEAEs) and adverse drug reactions were reported for safety. In total, 110 patients were randomized (1:1) to receive placebo or ONO-4474. The mean (standard deviation) change in VAS 24  scores at week 4 was -26.9 (25.0) mm in the ONO-4474 group and -19.5 (19.6) mm in the placebo group. The difference (ONO-4474 group - placebo group) in posterior mean change in VAS 24  at week 4 was -5.8 (posterior standard deviation, 4.4; 95% confidence interval, -14.3 to 2.8) mm. TEAEs were reported in 41.8% of patients in the ONO-4474 group and 18.2% of patients in the placebo group. The most common TEAEs in the ONO-4474 group related to the musculoskeletal system and the peripheral and central nervous systems were myalgia (7.3%), arthralgia (5.5%), dizziness (3.6%), and hypoesthesia (3.6%). Four patients from the ONO-4474 group and 1 patient from the placebo group discontinued treatment because of AEs; however, none were judged to be serious, and all patients recovered or were recovering after discontinuation. ONO-4474 is a novel tropomyosin receptor kinase inhibitor that has an analgesic effect in patients with OA.",2020,"The difference (ONO-4474 group - placebo group) in posterior mean change in VAS 24  at week 4 was -5.8 (posterior standard deviation, 4.4; 95% confidence interval, -14.3 to 2.8) ","['Japanese patients with osteoarthritis (OA) of the knee', 'Japanese Patients With Moderate to Severe Osteoarthritis of the Knee', '110 patients', 'patients with moderate to severe OA who were refractory to', 'patients with OA']","['placebo', 'nonsteroidal anti-inflammatory drugs were orally administered 100 mg of ONO-4474', 'ONO-4474, an Orally Available Pan-Tropomyosin Receptor Kinase Inhibitor', 'Placebo', 'placebo or ONO-4474', 'ONO-4474']","['Treatment-emergent adverse events (TEAEs) and adverse drug reactions', 'efficacy, safety, and tolerability', 'arthralgia', 'mean (standard deviation) change in VAS 24  scores', 'Efficacy, Safety, and Tolerability', 'knee pain during walking, assessed by visual analog scale', 'musculoskeletal system and the peripheral and central nervous systems were myalgia', 'dizziness']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0085999', 'cui_str': 'Genus Pan (organism)'}, {'cui': 'C0041197', 'cui_str': 'Tropomyosin'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C4521566', 'cui_str': 'Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0026860', 'cui_str': 'Musculoskeletal System'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",110.0,0.267013,"The difference (ONO-4474 group - placebo group) in posterior mean change in VAS 24  at week 4 was -5.8 (posterior standard deviation, 4.4; 95% confidence interval, -14.3 to 2.8) ","[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Ishiguro', 'Affiliation': 'Department of Orthopedic Surgery, Nagoya University Graduate School & Faculty of Medicine, Nagoya, Japan.'}, {'ForeName': 'Shusuke', 'Initials': 'S', 'LastName': 'Oyama', 'Affiliation': 'Data Science, Ono Pharmaceutical Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Ryunosuke', 'Initials': 'R', 'LastName': 'Higashi', 'Affiliation': 'Translational Science, Translational Medicine Center, Ono Pharmaceutical Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Kunio', 'Initials': 'K', 'LastName': 'Yanagida', 'Affiliation': 'Translational Science, Translational Medicine Center, Ono Pharmaceutical Co., Ltd., Osaka, Japan.'}]",Journal of clinical pharmacology,['10.1002/jcph.1470']
574,31285147,"Safety and efficacy of opicinumab in patients with relapsing multiple sclerosis (SYNERGY): a randomised, placebo-controlled, phase 2 trial.","BACKGROUND


Opicinumab is a human monoclonal antibody against LINGO-1, an inhibitor of oligodendrocyte differentiation and axonal regeneration. Previous findings suggested that opicinumab treatment might enhance remyelination in patients with CNS demyelinating diseases. We aimed to assess the safety and efficacy of opicinumab in patients with relapsing multiple sclerosis.
METHODS


We did a randomised, double-blind, placebo-controlled, dose-ranging, phase 2 study (SYNERGY) at 72 sites in 12 countries. Participants (aged 18-58 years) with relapsing multiple sclerosis (relapsing-remitting multiple sclerosis and secondary progressive multiple sclerosis with relapses) were randomised in a 1:2:2:2:2 ratio by an interactive voice and web response system to opicinumab 3 mg/kg, 10 mg/kg, 30 mg/kg, or 100 mg/kg, or placebo. An identical volume of study drug was administered intravenously once every 4 weeks. All participants self-administered intramuscular interferon beta-1a as background anti-inflammatory treatment once a week. The primary endpoint was the percentage of participants achieving confirmed disability improvement over 72 weeks, which was a multicomponent endpoint measured by the Expanded Disability Status Scale, the Timed 25-Foot Walk, the Nine-Hole Peg Test, and the 3 s Paced Auditory Serial Addition Test. The primary endpoint was analysed under intention-to-treat principles. This study is registered at ClinicalTrials.gov, number NCT01864148.
FINDINGS


Between Aug 13, 2013, and July 31, 2014, 419 patients were enrolled and randomly assigned either placebo (n=93) or opicinumab 3 mg/kg (n=45), 10 mg/kg (n=95), 30 mg/kg (n=94; one patient did not receive the assigned treatment), or 100 mg/kg (n=92). The last patient visit was on March 29, 2016. Confirmed disability improvement over 72 weeks was seen in 45 (49%) of 91 patients assigned to placebo, 21 (47%) of 45 assigned to opicinumab 3 mg/kg, 59 (63%) of 94 assigned to opicinumab 10 mg/kg, 59 (65%) of 91 assigned to opicinumab 30 mg/kg, and 36 (40%) of 91 assigned to opicinumab 100 mg/kg. A linear dose-response in the probability of confirmed disability improvement was not seen (linear trend test p=0·89). Adverse events occurred in 79 (85%) patients assigned placebo and in 275 (85%) assigned any dose of opicinumab. The most common adverse events of any grade in patients assigned any dose of opicinumab included influenza-like illness (140 [43%] with any dose of opicinumab vs 37 [40%] with placebo), multiple sclerosis relapses (117 [36%] vs 30 [32%]), and headache (51 [16%] vs 23 [25%]). Serious adverse events reported as related to treatment were urinary tract infection in one (1%) participant in the the placebo group, suicidal ideation and intentional overdose in one (1%) participant in the 30 mg/kg opicinumab group, bipolar disorder in one (1%) participant in the 100 mg/kg opicinumab group, and hypersensitivity in four (4%) participants in the 100 mg/kg opicinumab group. One patient in the opicinumab 30 mg/kg group died during the study due to a traffic accident, which was not considered related to study treatment.
INTERPRETATION


Our findings did not show a significant dose-linear improvement in disability compared with placebo in patients with relapsing multiple sclerosis. Further studies are needed to investigate whether some subpopulations identified in the study might benefit from opicinumab treatment at an optimum dose.
FUNDING


Biogen.",2019,Our findings did not show a significant dose-linear improvement in disability compared with placebo in patients with relapsing multiple sclerosis.,"['patients with relapsing multiple sclerosis', 'patients with relapsing multiple sclerosis (SYNERGY', 'patients with CNS demyelinating diseases', '419 patients', 'Between Aug 13, 2013, and July 31, 2014', '72 sites in 12 countries', 'Participants (aged 18-58 years) with relapsing multiple sclerosis (relapsing-remitting multiple sclerosis and secondary progressive multiple sclerosis with relapses']","['opicinumab 3 mg/kg', 'placebo', 'opicinumab']","['Expanded Disability Status Scale, the Timed 25-Foot Walk, the Nine-Hole Peg Test, and the 3 s Paced Auditory Serial Addition Test', 'safety and efficacy', 'under intention-to-treat principles', 'Adverse events', 'disability', 'percentage of participants achieving confirmed disability improvement', 'hypersensitivity', 'urinary tract infection', 'bipolar disorder', 'headache', 'influenza-like illness', 'suicidal ideation and intentional overdose', 'multiple sclerosis relapses', 'disability improvement', 'Safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0011303', 'cui_str': 'Demyelinating Disorders'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0751967', 'cui_str': 'Multiple Sclerosis, Relapsing-Remitting'}, {'cui': 'C0751965', 'cui_str': 'Multiple Sclerosis, Secondary Progressive'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C4550038', 'cui_str': 'opicinumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0451335', 'cui_str': 'Nine hole peg test (assessment scale)'}, {'cui': 'C0589060', 'cui_str': 'Paced Auditory Serial Addition Test'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0521839', 'cui_str': 'Influenza-like illness (finding)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0520804', 'cui_str': 'Intentional drug overdose (disorder)'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}]",419.0,0.496337,Our findings did not show a significant dose-linear improvement in disability compared with placebo in patients with relapsing multiple sclerosis.,"[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Cadavid', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Mellion', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Hupperts', 'Affiliation': 'Zuyderland Medical Center, Sittard, Netherlands.'}, {'ForeName': 'Keith R', 'Initials': 'KR', 'LastName': 'Edwards', 'Affiliation': 'Multiple Sclerosis Center of Northeastern New York, Latham, NY, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Calabresi', 'Affiliation': 'The Johns Hopkins Multiple Sclerosis Center, Baltimore, MD, USA.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Drulović', 'Affiliation': 'Clinic of Neurology, Clinical Centre of Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': 'Barts & The London School of Medicine & Dentistry, Queen Mary University, London, UK.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'Department of Neurology, Medical Faculty, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Arnold', 'Affiliation': 'Montreal Neurological Institute, Montreal, QC, Canada; NeuroRx Research, Montreal, QC, Canada.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Fisher', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rudick', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Sha', 'Initials': 'S', 'LastName': 'Mi', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Chai', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Yiwei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Biogen, Cambridge, MA, USA. Electronic address: bing.zhu@biogen.com.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Green', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Ih', 'Initials': 'I', 'LastName': 'Chang', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Deykin', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Sarah I', 'Initials': 'SI', 'LastName': 'Sheikh', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30137-1']
575,31220326,"Reach of a low-intensity, multicomponent childhood overweight and obesity intervention delivered in an integrated primary care setting.","Reach (i.e., proportion and representativeness of participants) of low-intensity, multicomponent childhood overweight/obesity interventions delivered in primary care settings with low-income and/or minority families is unknown. The purpose of this research is to describe the reach of a low-intensity, multicomponent childhood overweight/obesity intervention delivered in an integrated primary care setting in a federally qualified health center (FQHC). Eligibility criteria included children aged 4-10 years with a body mass index (BMI) ≥85th percentile, with a female caregiver. Using the electronic health record (EHR) and release forms, families were broadly categorized into groupings from recruitment flow, with differing proportions calculated from these groupings. Representativeness was determined using EHR data from families who were informed about the program (n = 963). Three calculated reach rates ranged from 54.9% to 3.9%. Lower reach rates were calculated using the number of families randomized (n = 73) as the numerator and the children from families who were informed about the program (n = 963) or all eligible children in the FQHC attending appointments (n = 1,864) as denominators. The first two steps in recruitment, informing families about the program and families initiating participation, were where the largest decreases in reach occurred. Children who were randomized were older, had a higher BMI, had a greater number of medical diagnoses indicating overweight or obesity, and were Hispanic. Reach of the intervention was low. Strategies that assist with reducing time for informing families of treatment and increasing families' awareness of their child's weight status should assist with enhancing reach.",2020,"Children who were randomized were older, had a higher BMI, had a greater number of medical diagnoses indicating overweight or obesity, and were Hispanic.","['Eligibility criteria included children aged 4-10 years with a body mass index (BMI) ≥85th percentile, with a female caregiver', 'Children who were randomized were older, had a higher BMI, had a greater number of medical diagnoses indicating overweight or obesity, and were Hispanic']",[],[],"[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}]",[],[],,0.0149515,"Children who were randomized were older, had a higher BMI, had a greater number of medical diagnoses indicating overweight or obesity, and were Hispanic.","[{'ForeName': 'Hollie A', 'Initials': 'HA', 'LastName': 'Raynor', 'Affiliation': 'Department of Nutrition, University of Tennessee Knoxville, Knoxville, TN, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Barroso', 'Affiliation': 'Department of Public Health, University of Tennessee Knoxville, Knoxville, TN, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Propst', 'Affiliation': 'Cherokee Health Systems, Knoxville, TN, USA.'}, {'ForeName': 'Kristoffer', 'Initials': 'K', 'LastName': 'Berlin', 'Affiliation': 'Department of Psychology, University of Memphis, Memphis, TH, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Robson', 'Affiliation': 'Department of Behavioral Health and Nutrition, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Parinda', 'Initials': 'P', 'LastName': 'Khatri', 'Affiliation': 'Cherokee Health Systems, Knoxville, TN, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibz055']
576,31786747,Self-setup of home respiratory polygraphy for the diagnosis of sleep apnea syndrome: cost-efficiency study.,"PURPOSE


To evaluate the differences in reliability and costs of home respiratory polygraphy (HRP) when installed by the patient and by a nurse, in order to determine the factors affecting and to consider the possible generalization of self-setup procedure. Several HRP devices have been validated for obstructive sleep apnea (OSA) diagnosis but convenience of a nurse intervention in HRP installation has been scarcely studied.
METHODS


This is a prospective and interventional study. About 301 participants were assigned to 2 groups: self-setup and nurse intervention. Sleep study, questionnaires, and diagnostic procedures were performed following the clinical practice in 2016. Signals were considered lost above 3 min, and success of the test was established according to guidelines. Costs were calculated according to a previous multicenter study.
RESULTS


Both groups (self-setup and nurse intervention) resulted homogeneous in age, gender, BMI, and final diagnosis of OSA. Signal losses during the test were similar in both groups. Slightly higher percentage of unsuccessful tests were obtained in the self-setup procedure (5.3 vs 2.0%, p = 0.121). The costs were similar (107 vs 105 €) in the self-setup group as compared to the nurse setup group.
CONCLUSIONS


The setup of HRP by either the patient or nurse had similar costs and data acquisition. Both installation procedures of HRP were similar regarding test reliability and costs. Main findings are that self-installation by the patient could be similarly reliable and economic as installation by a nurse, as far as consensus guidelines are followed. This study demonstrates that self-setup of HRP is a potentially viable option for the diagnosis of OSA.",2020,"The costs were similar (107 vs 105 €) in the self-setup group as compared to the nurse setup group.
","['301 participants were assigned to 2 groups', 'sleep apnea syndrome']","['HRP', 'Self-setup of home respiratory polygraphy', 'home respiratory polygraphy (HRP', 'self-setup and nurse intervention']","['unsuccessful tests', 'Signal losses']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}]","[{'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",301.0,0.0155532,"The costs were similar (107 vs 105 €) in the self-setup group as compared to the nurse setup group.
","[{'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Barriuso', 'Affiliation': 'Sleep Unit, Hospital Universitario de Burgos, Avda Baleares 3, 09006, Burgos, Spain. barriusoblanca@gmail.com.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': 'Sleep Unit, Hospital Universitario de Burgos, Avda Baleares 3, 09006, Burgos, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Sevilla', 'Affiliation': 'Sleep Unit, Hospital Universitario de Burgos, Avda Baleares 3, 09006, Burgos, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Muñoz', 'Affiliation': 'Sleep Unit, Hospital Universitario de Burgos, Avda Baleares 3, 09006, Burgos, Spain.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'López', 'Affiliation': 'Sleep Unit, Hospital Universitario de Burgos, Avda Baleares 3, 09006, Burgos, Spain.'}, {'ForeName': 'Ma Jose', 'Initials': 'MJ', 'LastName': 'Bello', 'Affiliation': 'Sleep Unit, Hospital Universitario de Burgos, Avda Baleares 3, 09006, Burgos, Spain.'}, {'ForeName': 'Nieves', 'Initials': 'N', 'LastName': 'Manchado', 'Affiliation': 'Sleep Unit, Hospital Universitario de Burgos, Avda Baleares 3, 09006, Burgos, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Pamiés', 'Affiliation': 'Sleep Unit, Hospital Universitario de Burgos, Avda Baleares 3, 09006, Burgos, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Díez', 'Affiliation': 'Sleep Unit, Hospital Universitario de Burgos, Avda Baleares 3, 09006, Burgos, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Sanz', 'Affiliation': 'Sleep Unit, Hospital Universitario de Burgos, Avda Baleares 3, 09006, Burgos, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Ciorba', 'Affiliation': 'Sleep Unit, Hospital Universitario de Burgos, Avda Baleares 3, 09006, Burgos, Spain.'}, {'ForeName': 'Estrella', 'Initials': 'E', 'LastName': 'Ordax', 'Affiliation': 'Sleep Unit, Hospital Universitario de Burgos, Avda Baleares 3, 09006, Burgos, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Terán-Santos', 'Affiliation': 'Sleep Unit, Hospital Universitario de Burgos, Avda Baleares 3, 09006, Burgos, Spain.'}, {'ForeName': 'María Luz', 'Initials': 'ML', 'LastName': 'Alonso-Alvarez', 'Affiliation': 'Sleep Unit, Hospital Universitario de Burgos, Avda Baleares 3, 09006, Burgos, Spain.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-019-01959-4']
577,31854207,Effect of Early Initiation of Varenicline on Smoking Cessation in COPD Patients Admitted for Exacerbation: The Save Randomized Clinical Trial.,"Our main objective was to demonstrate that, in smoker patients hospitalised for Chronic Obstructive Pulmonary Disease (COPD) exacerbation, early initiation of varenicline during 12 weeks, combined with an intensive counselling, is associated with a higher continuous abstainers rate (CAR) at one year as compared to intensive counselling alone. In this multicenter, prospective, double-blind, randomised study, 81 smoking COPD patients hospitalised for an acute exacerbation for at least 24 h were allocated to receive either varenicline ( n  = 42) or placebo ( n  = 39) for 12 weeks, in association with an intensive counselling in the 2 groups, and followed up for 40 weeks. The primary outcome was CAR at week 52. Secondary outcomes included CAR at week 12 and 26, partial abstinence rate (PAR) at week 12, 26 and 52, nicotinic substitute consumption and adverse events. At week 52, CAR was not different in placebo and varenicline groups (25.6%). At week 12, CAR was significantly higher in the varenicline group (50%) as compared to placebo group (27%) ( p  = 0.041). Nicotine consumption was significantly higher at week 52 in the placebo group (55.3%) as compared to the varenicline group (24.4%) ( p  = 0.005). There was no significant difference in PAR at week 12, 26 and 52; the frequency of adverse events was similar between the two groups. Among active smoker COPD patients with exacerbation, 12-week varenicline associated with intensive counselling for smoking cessation increased the rate of continuous abstainers as compared to placebo. However, benefit was not maintained after varenicline discontinuation. Clinical Trials Registration:  URL: http://www.controlled-trials.com. Unique identifier: NCT01694732.",2020,"At week 12, CAR was significantly higher in the varenicline group (50%) as compared to placebo group (27%) ( p  = 0.041).","['smoker patients hospitalised for Chronic Obstructive Pulmonary Disease (COPD) exacerbation, early initiation of', '81 smoking COPD patients hospitalised for an acute exacerbation for at least 24\u2009h', 'COPD Patients Admitted for Exacerbation', 'active smoker COPD patients with exacerbation, 12-week']","['Varenicline', 'varenicline', 'placebo']","['Smoking Cessation', 'rate of continuous abstainers', 'frequency of adverse events', 'CAR at week 12 and 26, partial abstinence rate (PAR) at week 12, 26 and 52, nicotinic substitute consumption and adverse events', 'Nicotine consumption', 'PAR']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004381', 'cui_str': 'Automobiles'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}]",81.0,0.550805,"At week 12, CAR was significantly higher in the varenicline group (50%) as compared to placebo group (27%) ( p  = 0.041).","[{'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Le Mao', 'Affiliation': ""Département de Médecine Vasculaire, Interne et Pneumologie, EA3878, Groupe D'Etude de la Thrombose de Bretagne Occidentale, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, France.""}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Tromeur', 'Affiliation': ""Département de Médecine Vasculaire, Interne et Pneumologie, EA3878, Groupe D'Etude de la Thrombose de Bretagne Occidentale, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, France.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Paleiron', 'Affiliation': 'Service de Pneumologie, HIA Toulon, Toulon, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Sanchez', 'Affiliation': 'Service de Pneumologie, Hôpital Européen Georges Pompidou, AP-HP, Université Paris Descartes, Sorbonne Paris Cité, and INSERM UMR S 1140, Paris, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Gagnadoux', 'Affiliation': 'Département de Pneumologie, Angers Université Bretagne Loire, INSERM UMR 1063, Angers, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Jouneau', 'Affiliation': 'Service de Pneumologie, Hôpital Pontchaillou, UMR 1085, Université de Rennes 1 (IRSET), Centre Hospitalo-Universitaire de Rennes, Rennes, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Magnan', 'Affiliation': 'CHU de Nantes, Service de Pneumologie, Institut du Thorax, INSERM, UMR1087, CNRS, UMR6291, Université de Nantes, Nantes, France.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Hayem-Vannimenus', 'Affiliation': 'Service de Pneumologie, Centre Hospital-Universitaire de Lille, Lille, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Dansou', 'Affiliation': 'Département de Pneumologie, Université François Rabelais CEPR/INSERM UMR1100, CHU de Tours, Tours, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Proust', 'Affiliation': 'Service de Pneumologie, Centre Hospitalo-Universitaire de Nîmes, France.'}, {'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Dion', 'Affiliation': ""Centre d'Investigation Clinique, INSERM 1412, Brest, France.""}, {'ForeName': 'Gaelle', 'Initials': 'G', 'LastName': 'Larhantec', 'Affiliation': 'Service de Pharmacie Central, Centre Hospitalo-Universitaire de Brest, Brest, France.'}, {'ForeName': 'Anne Le', 'Initials': 'AL', 'LastName': 'Brestec', 'Affiliation': ""Centre d'Investigation Clinique, INSERM 1412, Brest, France.""}, {'ForeName': 'Jean-Dominique', 'Initials': 'JD', 'LastName': 'Dewitte', 'Affiliation': 'Service de Pathologie Professionnelle, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Roche', 'Affiliation': 'Pneumologie et Soins Intensifs Respiratoires, Groupe Hospitalier Cochin, Université Paris Descartes (EA2511), AP-HP, Paris, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Leroyer', 'Affiliation': ""Département de Médecine Vasculaire, Interne et Pneumologie, EA3878, Groupe D'Etude de la Thrombose de Bretagne Occidentale, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, France.""}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Couturaud', 'Affiliation': ""Département de Médecine Vasculaire, Interne et Pneumologie, EA3878, Groupe D'Etude de la Thrombose de Bretagne Occidentale, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, France.""}]",COPD,['10.1080/15412555.2019.1703928']
578,30617130,Brentuximab Vedotin plus Chemotherapy in North American Subjects with Newly Diagnosed Stage III or IV Hodgkin Lymphoma.,"PURPOSE


To evaluate safety and efficacy outcomes for subjects on the ECHELON-1 study treated in North America (NA).
PATIENTS AND METHODS


ECHELON-1 is a global, open-label, randomized phase III study comparing doxorubicin, vinblastine, and dacarbazine in combination with brentuximab vedotin (A+AVD) versus ABVD (AVD + bleomycin) as first-line therapy in subjects with stage III or IV classical Hodgkin lymphoma (cHL; NCT01712490). Subjects were randomized 1:1 to receive A+AVD or ABVD intravenously on days 1 and 15 of each 28-day cycle for up to 6 cycles.
RESULTS


The NA subgroup consisted of 497 subjects in the A+AVD ( n  = 250) and ABVD ( n  = 247) arms. Similar to the primary analysis based on the intent-to-treat population, the primary endpoint [modified progression-free survival (PFS) per independent review] demonstrated an improvement among subjects who received A+AVD compared with ABVD (HR = 0.60;  P  = 0.012). For PFS, the risk of progression or death was also reduced (HR = 0.50;  P  = 0.002). Subsequent anticancer therapies were lower in the A+AVD arm. Grade 3 or 4 adverse events (AEs) were more common, but there were fewer study discontinuations due to AEs in the A+AVD arm as compared with ABVD. Noted differences between arms included higher rates of febrile neutropenia (20% vs. 9%) and peripheral neuropathy (80% vs. 56%), but lower rates of pulmonary toxicity (3% vs. 10%) in subjects treated with A+AVD versus ABVD.
CONCLUSIONS


The efficacy benefit and manageable toxicity profile observed in the NA subgroup of ECHELON-1 support A+AVD as a frontline treatment option for patients with stage III or IV cHL.",2019,"Grade 3 or 4 adverse events (AEs) were more common, but there were fewer study discontinuations due to AEs in the A+AVD arm as compared with ABVD.","['North American Subjects with Newly Diagnosed Stage III or IV Hodgkin Lymphoma', '497 subjects in the A+AVD ( n  = 250) and ABVD ( n  = 247) arms', 'patients with stage III or IV cHL', 'subjects with stage III or IV classical Hodgkin lymphoma (cHL; NCT01712490', 'subjects on the ECHELON-1 study treated in North America (NA']","['Brentuximab Vedotin plus Chemotherapy', 'A+AVD or ABVD', 'doxorubicin, vinblastine, and dacarbazine in combination with brentuximab vedotin (A+AVD) versus ABVD (AVD + bleomycin']","['progression-free survival (PFS', 'febrile neutropenia', 'efficacy benefit and manageable toxicity profile', 'pulmonary toxicity', 'peripheral neuropathy', 'Grade 3 or 4 adverse events (AEs', 'safety and efficacy outcomes', 'risk of progression or death']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1333064', 'cui_str': 'Classical Hodgkin lymphoma (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0028405', 'cui_str': 'North America'}]","[{'cui': 'C2973446', 'cui_str': 'brentuximab vedotin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0919924', 'cui_str': 'Pulmonary toxicity'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",497.0,0.110861,"Grade 3 or 4 adverse events (AEs) were more common, but there were fewer study discontinuations due to AEs in the A+AVD arm as compared with ABVD.","[{'ForeName': 'Radhakrishnan', 'Initials': 'R', 'LastName': 'Ramchandren', 'Affiliation': 'Department of Hematology/Oncology, Barbara Ann Karmanos Cancer Center, Detroit, Michigan. RRamchandren@utmck.edu.'}, {'ForeName': 'Ranjana H', 'Initials': 'RH', 'LastName': 'Advani', 'Affiliation': 'Department of Medicine, Stanford University, Palo Alto, California.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Ansell', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': 'Division of Oncology, Siteman Cancer Center, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology and Hematopoietic Cell Transplantation, City of Hope National Medical Center, Duarte, California.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Connors', 'Affiliation': 'University of British Columbia and the Department of Medical Oncology, British Columbia Cancer Centre for Lymphoid Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Feldman', 'Affiliation': 'John Theurer Cancer Centre, Hackensack University Medical Center, Hackensack, New Jersey.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Forero-Torres', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Friedberg', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Gopal', 'Affiliation': 'Fred Hutchinson Cancer Research Center, University of Washington, Seattle, Washington.'}, {'ForeName': 'Leo I', 'Initials': 'LI', 'LastName': 'Gordon', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kuruvilla', 'Affiliation': 'Division of Medical Oncology and Hematology, Princess Margaret Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Kerry J', 'Initials': 'KJ', 'LastName': 'Savage', 'Affiliation': 'University of British Columbia and the Department of Medical Oncology, British Columbia Cancer Centre for Lymphoid Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Anas', 'Initials': 'A', 'LastName': 'Younes', 'Affiliation': 'Lymphoma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Engley', 'Affiliation': 'Seattle Genetics, Inc., Bothell, Washington.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Manley', 'Affiliation': 'Seattle Genetics, Inc., Bothell, Washington.'}, {'ForeName': 'Keenan', 'Initials': 'K', 'LastName': 'Fenton', 'Affiliation': 'Seattle Genetics, Inc., Bothell, Washington.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Straus', 'Affiliation': 'Lymphoma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-2435']
579,31256599,"The Effect of Conjugated Linoleic Acid Supplementation on Body Composition, Serum Insulin and Leptin in Obese Adults.","BACKGROUND


Studies have reported contradictory findings regarding the effect of a mixture of 2 conjugated linoleic acid (CLA) isomers on body weight and some serum indices. This study aims to investigate the effect of daily supplementation of these 2 isomers on body composition and serum leptin and insulin levels in obese adults.
METHODS


This randomized, double-blind clinical trial was performed on 54 adults with class I obesity. The subjects were randomly assigned into 2 groups of 27 and were followed for 3 months so that a total of 3000 mg of CLA supplement and placebo were administered in 3 daily doses in the intervention and control groups, respectively. Body composition indices as well as fasting serum levels of insulin and leptin were also measured. The paired t-test was used for evaluating within-group effects from baseline. The independent t-test was used to compare between-group differences for variables with normal distribution.
RESULTS


Although body weight and body mass index (BMI) were not significantly decreased during intervention in groups, but the body fat mass (BFM) (P=0.034), body fat percentage (P=0.022) and trunk fat (P=0.027) decreased significantly during intervention with CLA. The fasting plasma sugar (P=0.042) and Homeostatic model assessment for insulin resistance (HOMA/IR) (P=0.044) in the intervention group declined during 12 weeks of intervention. Serum leptin was associated with a significant decrease during the intervention period (P=0.039).
CONCLUSION


CLA supplementation could reduce body fat and serum leptin. Hence, it could be taken into account as a factor for weight loss but not to control or prevent diabetes.",2019,The fasting plasma sugar (P=0.042) and Homeostatic model assessment for insulin resistance (HOMA/IR) (P=0.044) in the intervention group declined during 12 weeks of intervention.,"['obese adults', '54 adults with class I obesity', 'Obese Adults']","['Conjugated Linoleic Acid Supplementation', 'CLA supplement and placebo', 'CLA supplementation', 'linoleic acid (CLA']","['Serum leptin', 'fasting plasma sugar', 'trunk fat', 'weight loss', 'body fat and serum leptin', 'Homeostatic model assessment for insulin resistance (HOMA/IR', 'body composition and serum leptin and insulin levels', 'body weight and body mass index (BMI', 'body fat mass (BFM', 'fasting serum levels of insulin and leptin', 'body fat percentage', 'Body Composition, Serum Insulin and Leptin']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}]","[{'cui': 'C1257880', 'cui_str': 'Linoleic Acids, Conjugated'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023750', 'cui_str': 'Linoleic Acids'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}]",54.0,0.0611243,The fasting plasma sugar (P=0.042) and Homeostatic model assessment for insulin resistance (HOMA/IR) (P=0.044) in the intervention group declined during 12 weeks of intervention.,"[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Esmaeili Shahmirzadi', 'Affiliation': 'Food and Beverage safety research center, Department of Human Nutrition, Medicine Faculty, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Ghavamzadeh', 'Affiliation': 'Food and Beverage safety research center, Department of Human Nutrition, Medicine Faculty, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Tayebeh', 'Initials': 'T', 'LastName': 'Zamani', 'Affiliation': 'Food and Beverage safety research center, Department of Human Nutrition, Medicine Faculty, Urmia University of Medical Sciences, Urmia, Iran.'}]",Archives of Iranian medicine,[]
580,31179791,"Dupilumab improves patient-reported symptoms of atopic dermatitis, symptoms of anxiety and depression, and health-related quality of life in moderate-to-severe atopic dermatitis: analysis of pooled data from the randomized trials SOLO 1 and SOLO 2.","Background:  Atopic dermatitis (AD) profoundly affects quality of life (QoL). Dupilumab significantly improves clinical outcomes, is well tolerated, and approved to treat inadequately controlled moderate-to-severe AD in adults; however, its effect on patient-reported outcomes (PROs) is not fully characterized. Objective:  To evaluate the impact of dupilumab on patient-reported AD symptoms and QoL. Methods:  Pooled data were analyzed from two identically designed phase 3 studies, LIBERTY AD SOLO 1 (NCT02277743) and SOLO 2 (NCT02277769), assessing the following PROs: Peak Pruritus Numerical Rating Scale (NRS), Pruritus Categorical Scale, SCORing AD (SCORAD), Dermatology Life Quality Index (DLQI), Patient-Oriented Eczema Measure (POEM), Hospital Anxiety and Depression Scale (HADS), five-dimension EuroQoL questionnaire (EQ-5D), and patient-assessed disease status and treatment effectiveness. Results:  Dupilumab rapidly improved (vs. placebo) Peak Pruritus NRS scores by day 2 ( p  < .05), anxiety and depression (HADS), and QoL (DLQI) by week 2, and maintained through week 16 ( p  < .0001). At week 16, more dupilumab-treated than placebo-treated patients reported improvement in SCORAD itch and sleep, and no pain/discomfort (EQ-5D) ( p  < .0001). Limitations:  Cultural differences of translated PROs. Conclusion:  Dupilumab had a significant, positive impact on AD symptoms, including itch, sleep, pain, anxiety and depression, and QoL in adults with moderate-to-severe AD.",2020,"Peak Pruritus NRS scores by day 2 ( p  < .05), anxiety and depression (HADS), and QoL (DLQI) by week 2, and maintained through week 16 ( p  < .0001).",[':  Atopic dermatitis (AD'],"['Dupilumab', 'placebo']","['clinical outcomes', 'PROs: Peak Pruritus Numerical Rating Scale (NRS), Pruritus Categorical Scale, SCORing AD (SCORAD), Dermatology Life Quality Index (DLQI), Patient-Oriented Eczema Measure (POEM), Hospital Anxiety and Depression Scale (HADS), five-dimension EuroQoL questionnaire (EQ-5D), and patient-assessed disease status and treatment effectiveness', 'AD symptoms, including itch, sleep, pain, anxiety and depression, and QoL', 'Peak Pruritus NRS scores', 'quality of life (QoL', 'atopic dermatitis, symptoms of anxiety and depression, and health-related quality of life', 'anxiety and depression (HADS), and QoL (DLQI', 'SCORAD itch and sleep, and no pain/discomfort (EQ-5D']","[{'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}]","[{'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}, {'cui': 'C4304942', 'cui_str': 'Patient-Oriented Eczema Measure (assessment scale)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034380'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}]",,0.176387,"Peak Pruritus NRS scores by day 2 ( p  < .05), anxiety and depression (HADS), and QoL (DLQI) by week 2, and maintained through week 16 ( p  < .0001).","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Cork', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection and Immunity, University of Sheffield Medical School, Beech Hill, Sheffield, UK.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Eckert', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Armstrong', 'Affiliation': 'Department of Dermatology, Keck School of Medicine at USC, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Barbarot', 'Affiliation': 'Department of Dermatology, CHU Hôtel-Dieu, Nantes, France.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Puig', 'Affiliation': 'Department of Dermatology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Giampiero', 'Initials': 'G', 'LastName': 'Girolomoni', 'Affiliation': 'Department of Medicine, Section of Dermatology and Venereology, University of Verona, Verona, Italy.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'de Bruin-Weller', 'Affiliation': 'University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wollenberg', 'Affiliation': 'Klinikum der Universität München, Klinik und Poliklinik für Dermatologie und Allergologie, Munich, Germany.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Kataoka', 'Affiliation': 'Department of Dermatology, Osaka Habikino Medical Center, Habikino City, Osaka, Japan.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Remitz', 'Affiliation': 'Helsinki University Central Hospital, Helsinki, Finland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Beissert', 'Affiliation': 'Department of Dermatology, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Mastey', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Ardeleanu', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Gadkari', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Jingdong', 'Initials': 'J', 'LastName': 'Chao', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.'}]",The Journal of dermatological treatment,['10.1080/09546634.2019.1612836']
581,30875090,Effect of Intravenous Oxycodone Versus Sufentanil on the Incidence of Postoperative Nausea and Vomiting in Patients Undergoing Gynecological Laparoscopic Surgery.,"More than 30% of patients who undergo surgery will experience postoperative nausea and vomiting (PONV) if no prophylactic treatments are used. Although numerous studies have been performed to investigate the factors related to PONV, the effect of perioperative intravenous oxycodone on the incidence of PONV has not been well investigated. In this study, gynecological patients (grade I-II, aged 18-65 years, scheduled to undergo elective gynecological laparoscopic surgery under general anesthesia) were randomized to the oxycodone group or the sufentanil group. In the oxycodone group, patients received intravenous oxycodone for the induction and maintenance of anesthesia, as well as postoperative analgesia, while sufentanil was used in the sufentanil group. The primary outcome variable was the incidence of PONV. As secondary outcomes, time to first PONV, the rating of the most severe PONV, postoperative pain scores at different time points, hemodynamics, and side effects were evaluated. We found that, compared with sufentanil, oxycodone decreased the incidence of PONV by 13.5% (P = .041). The time to first vomiting was longer in the oxycodone group than in the sufentanil group. Postoperative pain scores at different time points and hemodynamics were comparable between the oxycodone and sufentanil groups. We concluded that the incidence of PONV in gynecological patients who underwent laparoscopic surgery was lower when using intravenous oxycodone for anesthesia induction, anesthesia maintenance, and postoperative analgesia than when using intravenous sufentanil. However, oxycodone and sufentanil provided the same stable hemodynamics during surgery and satisfactory postoperative analgesia.",2019,Postoperative pain scores at different time points and hemodynamics were comparable between the oxycodone and sufentanil groups.,"['Patients Undergoing Gynecological Laparoscopic Surgery', 'gynecological patients (grade I-II, aged 18-65 years, scheduled to undergo elective gynecological laparoscopic surgery under general anesthesia', 'gynecological patients who underwent']","['Oxycodone Versus Sufentanil', 'oxycodone', 'laparoscopic surgery', 'sufentanil', 'intravenous oxycodone', 'sufentanil, oxycodone', 'oxycodone and sufentanil']","['Postoperative Nausea and Vomiting', 'experience postoperative nausea and vomiting (PONV', 'incidence of PONV', 'Postoperative pain scores', 'time to first vomiting', 'time to first PONV, the rating of the most severe PONV, postoperative pain scores at different time points, hemodynamics, and side effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.139404,Postoperative pain scores at different time points and hemodynamics were comparable between the oxycodone and sufentanil groups.,"[{'ForeName': 'Bingdong', 'Initials': 'B', 'LastName': 'Tao', 'Affiliation': 'Department of Anesthesiology, Shengjing Hospital, China Medical University, Shanghai, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Shengjing Hospital, China Medical University, Shanghai, China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Shengjing Hospital, China Medical University, Shanghai, China.'}, {'ForeName': 'Mengmeng', 'Initials': 'M', 'LastName': 'Ding', 'Affiliation': 'Department of Anesthesiology, Shengjing Hospital, China Medical University, Shanghai, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, Shengjing Hospital, China Medical University, Shanghai, China.'}]",Journal of clinical pharmacology,['10.1002/jcph.1408']
582,31796263,Knowledge is power: Providing previsit insurance coverage information of body contouring procedures to improve understanding and satisfaction in the massive weight loss patient.,"INTRODUCTION


Because of the prevalence of obesity worldwide, the rates of bariatric surgery are increasing. Bariatric surgery is covered by insurance; however, often, a surgery to correct massive weight loss surgeries is not covered despite patient perception.
METHODS


One hundred patients were identified by their initial visit to the institutional Life After Weight Loss center. Fifty of them were randomized into receiving previsit educational materials about their individual insurance plans. All the patients were surveyed to assess whether this education improved their understanding and overall consultation experience.
RESULTS


Although a majority of patients believed ""panniculectomy"" would be covered by insurance, most subjects overestimated insurance coverage for other procedures. Nearly all respondents (93.8%) agreed that previsit educational material improved their understanding and the satisfaction of the visit.
CONCLUSION


Many patients believe body contouring procedures to be covered by insurance, although most are not. By providing patients with their individualized insurance plans, patients report improved understanding and overall satisfaction with the consultation.",2020,"Nearly all respondents (93.8%) agreed that previsit educational material improved their understanding and the satisfaction of the visit.
",['One hundred patients were identified by their initial visit to the institutional Life'],['previsit educational materials'],['previsit educational material improved their understanding and the satisfaction of the visit'],"[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",100.0,0.0201491,"Nearly all respondents (93.8%) agreed that previsit educational material improved their understanding and the satisfaction of the visit.
","[{'ForeName': 'Paige L', 'Initials': 'PL', 'LastName': 'Myers', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, University of Rochester, Rochester NY 14642, United States.'}, {'ForeName': 'Rachel H', 'Initials': 'RH', 'LastName': 'Park', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, University of Rochester, Rochester NY 14642, United States.'}, {'ForeName': 'Valeriia', 'Initials': 'V', 'LastName': 'Sherina', 'Affiliation': 'Department of Biostatistics and Computational Biology, University of Rochester, Rochester NY, United States.'}, {'ForeName': 'Ronald P', 'Initials': 'RP', 'LastName': 'Bossert', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, University of Rochester, Rochester NY 14642, United States. Electronic address: ronald_bossert@urmc.rochester.edu.'}]","Journal of plastic, reconstructive & aesthetic surgery : JPRAS",['10.1016/j.bjps.2019.09.052']
583,31233135,Efficacy of Home-Based Telerehabilitation vs In-Clinic Therapy for Adults After Stroke: A Randomized Clinical Trial.,"Importance


Many patients receive suboptimal rehabilitation therapy doses after stroke owing to limited access to therapists and difficulty with transportation, and their knowledge about stroke is often limited. Telehealth can potentially address these issues.
Objectives


To determine whether treatment targeting arm movement delivered via a home-based telerehabilitation (TR) system has comparable efficacy with dose-matched, intensity-matched therapy delivered in a traditional in-clinic (IC) setting, and to examine whether this system has comparable efficacy for providing stroke education.
Design, Setting, and Participants


In this randomized, assessor-blinded, noninferiority trial across 11 US sites, 124 patients who had experienced stroke 4 to 36 weeks prior and had arm motor deficits (Fugl-Meyer [FM] score, 22-56 of 66) were enrolled between September 18, 2015, and December 28, 2017, to receive telerehabilitation therapy in the home (TR group) or therapy at an outpatient rehabilitation therapy clinic (IC group). Primary efficacy analysis used the intent-to-treat population.
Interventions


Participants received 36 sessions (70 minutes each) of arm motor therapy plus stroke education, with therapy intensity, duration, and frequency matched across groups.
Main Outcomes and Measures


Change in FM score from baseline to 4 weeks after end of therapy and change in stroke knowledge from baseline to end of therapy.
Results


A total of 124 participants (34 women and 90 men) had a mean (SD) age of 61 (14) years, a mean (SD) baseline FM score of 43 (8) points, and were enrolled a mean (SD) of 18.7 (8.9) weeks after experiencing a stroke. Among those treated, patients in the IC group were adherent to 33.6 of the 36 therapy sessions (93.3%) and patients in the TR group were adherent to 35.4 of the 36 assigned therapy sessions (98.3%). Patients in the IC group had a mean (SD) FM score change of 8.36 (7.04) points from baseline to 30 days after therapy (P < .001), while those in the TR group had a mean (SD) change of 7.86 (6.68) points (P < .001). The covariate-adjusted mean FM score change was 0.06 (95% CI, -2.14 to 2.26) points higher in the TR group (P = .96). The noninferiority margin was 2.47 and fell outside the 95% CI, indicating that TR is not inferior to IC therapy. Motor gains remained significant when patients enrolled early (<90 days) or late (≥90 days) after stroke were examined separately.
Conclusions and Relevance


Activity-based training produced substantial gains in arm motor function regardless of whether it was provided via home-based telerehabilitation or traditional in-clinic rehabilitation. The findings of this study suggest that telerehabilitation has the potential to substantially increase access to rehabilitation therapy on a large scale.
Trial Registration


ClinicalTrials.gov identifier: NCT02360488.",2019,"Motor gains remained significant when patients enrolled early (<90 days) or late (≥90 days) after stroke were examined separately.
","['Adults', '124 participants (34 women and 90 men) had a mean (SD) age of 61 (14) years, a mean (SD) baseline FM score of 43 (8) points, and were enrolled a mean (SD) of 18.7 (8.9) weeks after experiencing a stroke', '124 patients who had experienced stroke 4 to 36 weeks prior and had arm motor deficits (Fugl-Meyer [FM] score, 22-56 of 66) were enrolled between September 18, 2015, and December 28, 2017, to receive']","['Home-Based Telerehabilitation vs In-Clinic Therapy', 'telerehabilitation therapy in the home (TR group) or therapy at an outpatient rehabilitation therapy clinic (IC group', 'suboptimal rehabilitation therapy', 'arm movement delivered via a home-based telerehabilitation (TR) system']","['covariate-adjusted mean FM score change', 'stroke knowledge', 'FM score', 'mean (SD) FM score change', 'Motor gains']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0521654', 'cui_str': 'Neurologic Deficits'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4042802', 'cui_str': 'Tele-rehabilitation'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",124.0,0.226829,"Motor gains remained significant when patients enrolled early (<90 days) or late (≥90 days) after stroke were examined separately.
","[{'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Cramer', 'Affiliation': 'Department of Neurology, University of California, Irvine.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Dodakian', 'Affiliation': 'Department of Neurology, University of California, Irvine.'}, {'ForeName': 'Vu', 'Initials': 'V', 'LastName': 'Le', 'Affiliation': 'Department of Neurology, University of California, Irvine.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'See', 'Affiliation': 'Department of Neurology, University of California, Irvine.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Augsburger', 'Affiliation': 'Department of Neurology, University of California, Irvine.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McKenzie', 'Affiliation': 'Department of Neurology, University of California, Irvine.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, University of California, Irvine.'}, {'ForeName': 'Nina L', 'Initials': 'NL', 'LastName': 'Chiu', 'Affiliation': 'Department of Neurology, University of California, Irvine.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Heckhausen', 'Affiliation': 'Department of Psychological Science, University of California, Irvine.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Cassidy', 'Affiliation': 'Department of Neurology, University of California, Irvine.'}, {'ForeName': 'Walt', 'Initials': 'W', 'LastName': 'Scacchi', 'Affiliation': 'Institute for Software Research, University of California, Irvine.'}, {'ForeName': 'Megan Therese', 'Initials': 'MT', 'LastName': 'Smith', 'Affiliation': 'Department of Statistics, University of California, Irvine.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Barrett', 'Affiliation': 'Department of Stroke Rehabilitation Research, Kessler Foundation, West Orange, New Jersey.'}, {'ForeName': 'Jayme', 'Initials': 'J', 'LastName': 'Knutson', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, MetroHealth System, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Edwards', 'Affiliation': 'Brain Stimulation and Robotics Laboratory, Burke Neurological Institute, White Plains, New York.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Putrino', 'Affiliation': 'Department of Telemedicine and Virtual Rehabilitation, Burke Medical Research Institute, White Plains, New York.'}, {'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Agrawal', 'Affiliation': 'Department of Clinical Neurosciences, University of California, San Diego, La Jolla.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Ngo', 'Affiliation': 'Brooks Rehabilitation Clinical Research Center, Brooks Rehabilitation, Jacksonville, Florida.'}, {'ForeName': 'Elliot J', 'Initials': 'EJ', 'LastName': 'Roth', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Tirschwell', 'Affiliation': 'Department of Neurology, University of Washington, Seattle.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Woodbury', 'Affiliation': 'Department of Health Science and Research, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Zafonte', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Boston, Massachusetts.'}, {'ForeName': 'Wenle', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Spilker', 'Affiliation': 'Department of Neurology, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Wolf', 'Affiliation': 'Division of Physical Therapy Education, Department of Rehabilitation Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Broderick', 'Affiliation': 'Department of Neurology, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Janis', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2019.1604']
584,31203649,Effects of Brief Behavioral Treatment for Insomnia on Daily Associations between Self-Reported Sleep and Objective Cognitive Performance in Older Adults.,"OBJECTIVE


Behavioral treatments for insomnia improve sleep in older adults, but research documenting their effects on cognitive performance is mixed. We explored whether a brief behavioral treatment for insomnia (BBTi) impacts daily associations between sleep parameters and next day cognition.
METHODS


Sixty-two older adults ( M age   = 69.45 years,  SD  = 7.71) with insomnia completed either 4 weeks of BBTi or self-monitoring control (SMC). At baseline, post-treatment, and 3 month follow-up, participants completed 14 days of diaries measuring sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), and sleep efficiency (SE), as well as daily cognitive tests measuring processing speed (i.e., symbol digit modalities test, SDMT), and reasoning (i.e., letter series). At each time period, associations between sleep parameters and daily cognition, controlling for age, education, insomnia duration, use of sleep medications, and depression (i.e., Beck Depression Inventory-2 nd  Edition scores), were examined through multilevel modeling.
RESULTS


At post-treatment, we observed an interactive fixed effect of treatment condition (i.e., BBTi/SMC) and TST on daily SDMT and letter series performance. For BBTi, longer TST was associated with better letter series performance, and did not predict SDMT performance. For SMC, longer TST was associated with worse SDMT, and was not associated with letter series performance. Greater WASO (regardless of group) was associated with better SDMT performance at post-treatment. Associations were not maintained at follow-up.
CONCLUSIONS


Sleep duration may play an important role in BBTi-related improvements in daily higher order cognition. Maintenance of these associations may be facilitated by booster sessions following post-treatment.
CLINICAL TRIAL IDENTIFIER


NCT02967185.",2020,Greater WASO (regardless of group) was associated with better SDMT performance at post-treatment.,"['Sixty-two older adults ( M age \xa0 ', '69.45\xa0years,  SD\xa0 =\xa07.71) with insomnia completed either 4\xa0weeks of BBTi or self-monitoring control (SMC', 'Older Adults', 'older adults']",['Brief Behavioral Treatment'],"['diaries measuring sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), and sleep efficiency (SE), as well as daily cognitive tests measuring processing speed (i.e., symbol digit modalities test, SDMT), and reasoning (i.e., letter series', 'Greater WASO', 'SDMT performance', 'sleep parameters and daily cognition, controlling for age, education, insomnia duration, use of sleep medications, and depression (i.e., Beck Depression Inventory-2 nd  Edition scores']","[{'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517861', 'cui_str': '7.71'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0451522', 'cui_str': 'Symbol Digit Modalities Test'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",62.0,0.0251172,Greater WASO (regardless of group) was associated with better SDMT performance at post-treatment.,"[{'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'McCrae', 'Affiliation': 'Department of Psychiatry, University of Missouri-Columbia , Columbia, MO.'}, {'ForeName': 'Ashley F', 'Initials': 'AF', 'LastName': 'Curtis', 'Affiliation': 'Department of Psychiatry, University of Missouri-Columbia , Columbia, MO.'}, {'ForeName': 'Jacob M', 'Initials': 'JM', 'LastName': 'Williams', 'Affiliation': 'TIRR Memorial Hermann , Houston, TX.'}, {'ForeName': 'Natalie D', 'Initials': 'ND', 'LastName': 'Dautovich', 'Affiliation': 'Psychology Department, Virginia Commonwealth University , Richmond, VA.'}, {'ForeName': 'Joseph P H', 'Initials': 'JPH', 'LastName': 'McNamara', 'Affiliation': 'Department of Psychiatry, University of Florida , Gainesville, FL.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Stripling', 'Affiliation': 'College of Psychology, Nova Southeastern University , Fort Lauderdale, Florida.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Dzierzewski', 'Affiliation': 'Psychology Department, Virginia Commonwealth University , Richmond, VA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Berry', 'Affiliation': 'College of Medicine, University of Florida , Gainesville, FL.'}, {'ForeName': 'Karin M', 'Initials': 'KM', 'LastName': 'McCoy', 'Affiliation': 'Neuropsychology Service, South Texas Veterans Health Care System , San Antonio, TX.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Marsiske', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida , Gainesville, FL.'}]",Behavioral sleep medicine,['10.1080/15402002.2019.1632201']
585,31804028,"Long-Pulsed Nd:YAG (1,064 nm) Laser Versus Q-Switched Nd:YAG (1,064 nm) Laser for Treatment of Onychomycosis.","BACKGROUND AND OBJECTIVES


To compare the efficacy of the long-pulsed Nd:YAG (1,064 nm) laser versus the Q-Switched Nd:YAG (1,064 nm) laser in treatment of onychomycosis.
STUDY DESIGN/MATERIALS AND METHODS


This is a prospective cohort study. It was carried out on 20 patients with clinical and mycological evidence of onychomycosis who were randomly assigned into two groups; group I: included 10 patients treated with biweekly sessions of long-pulsed Nd:YAG (1064 nm) laser and group II; included 10 patients treated with monthly sessions of Q-Switched Nd:YAG (1064 nm) laser. The assessment was done using proximal nail measurement and microscopic examination using 10-20% potassium hydroxide solution and culture on Sabouraud's dextrose agar. All patients were followed up for 6 months after the last treatment session.
RESULTS


Fungal isolates in the present study were grouped into yeast in 50%, non-dermatophyte moulds in 10%, while dermatophyte infection was detected in 40%. Each group showed a statistically significant improvement in proximal nail plate measurements with no statistically significant difference between both groups. Mycological cure was only achieved in 40% of group I and 30% of group II. Patient satisfaction was higher in group II.
CONCLUSIONS


Both long-pulsed Nd:YAG (1064 nm) and Q-Switched Nd:YAG (1064 nm) laser systems can be used as a safe and effective modality in the treatment of onychomycosis, particularly in patients who refuse or have a contraindication to oral antifungal treatment. Lasers Surg. Med. 00:00-00, 2019. © 2019 Wiley Periodicals, Inc.",2020,Each group showed a statistically significant improvement in proximal nail plate measurements with no statistically significant difference between both groups.,"['patients who refuse or have a contraindication to oral antifungal treatment', '2019', '20 patients with clinical and mycological evidence of onychomycosis who']","['long-pulsed Nd:YAG (1,064\u2009nm) laser versus the Q-Switched Nd', 'biweekly sessions of long-pulsed Nd:YAG (1064 nm) laser and group II; included 10 patients\xa0treated with monthly sessions of Q-Switched Nd:YAG', ""potassium hydroxide solution and culture on Sabouraud's dextrose agar"", 'Long-Pulsed Nd:YAG (1,064\u2009nm', 'Laser Versus Q-Switched Nd:YAG', 'YAG']","['Patient satisfaction', 'dermatophyte infection', 'proximal nail plate measurements', 'Mycological cure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2363963', 'cui_str': 'Antifungal treatment'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205467', 'cui_str': 'Mycologic (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0040261', 'cui_str': 'Tinea Unguium'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0585332', 'cui_str': 'Biweekly (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0071767', 'cui_str': 'Potassium Hydroxide'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0001771', 'cui_str': 'Agar'}]","[{'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0011630', 'cui_str': 'Dermatophyte Infection'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205467', 'cui_str': 'Mycologic (qualifier value)'}]",,0.0176963,Each group showed a statistically significant improvement in proximal nail plate measurements with no statistically significant difference between both groups.,"[{'ForeName': 'Eman H', 'Initials': 'EH', 'LastName': 'Elmorsy', 'Affiliation': 'Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Nouran A', 'Initials': 'NA', 'LastName': 'Abou Khadr', 'Affiliation': 'Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Alsayeda A A', 'Initials': 'AAA', 'LastName': 'Taha', 'Affiliation': 'Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Doaa M', 'Initials': 'DM', 'LastName': 'Abdel Aziz', 'Affiliation': 'Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}]",Lasers in surgery and medicine,['10.1002/lsm.23200']
586,32298728,Palivizumab Following Extremely Premature Birth Does Not Affect Pulmonary Outcomes in Adolescence.,"BACKGROUND


Prematurity is a risk factor for impaired lung function. We sought to assess the long-term effect of palivizumab immunization and extreme prematurity (<29 weeks gestation) on respiratory symptoms and pulmonary function in adolescence.
RESEARCH QUESTION


What is the long-term effect of palivizumab immunization and extreme prematurity (<29 weeks) on respiratory symptoms and pulmonary function in adolescence?
STUDY DESIGN AND METHODS


We examined survivors of extreme prematurity (<29 weeks gestation) at 13 to 18 years of age (study group). Study group babies who were born immediately before palivizumab immunization (nonpalivizumab group [NPG]) were compared with those babies who were born just after implementation (PG) and with a control group. For study group patients, lung function in adolescence was further compared longitudinally with that at primary school age.
RESULTS


Sixty-four adolescents aged 15.76 ± 1.52 years were included: 46 in the study group (17 PG and 29 NPG) and 18 in the control group. For the study group, wheezing episodes, inhaler use, and hospitalizations were uncommon. For the study group compared with the control group, FEV 1  percent predicted was 82.60% ± 13.54% vs 105.83% ± 13.12% (P < .001), and the lung clearance index was 7.67 ± 1.02 vs 7.46 ± 0.70 (P = .48), respectively. Study group adolescents with bronchopulmonary dysplasia had a higher lung clearance index than did adolescents with no bronchopulmonary dysplasia (7.94 ± 1.11 vs 7.20 ± 0.60; P = .002). PG and NPG adolescents were not significantly different. Comparing the study group in adolescence with primary school age, we found improvement in mean FEV 1  percent predicted bronchodilator response (0.37% ± 9.98% vs 5.67% ± 9.87%; P = .036) and mean provocative concentration causing 20% decline in FEV 1  (12.16 ± 4.71 mg/mL vs 4.14 ± 4.51 mg/mL, respectively; P < .001).
INTERPRETATION


Palivizumab did not provide any discernable long-term protective effect. Nevertheless, adolescent survivors of extreme prematurity showed good clinical and physiologic outcomes, except for mildly raised lung clearance index in patients with bronchopulmonary dysplasia. Airway hyperreactivity detected at primary school age, decreased by adolescence.",2020,"For the study group compared with the control group, FEV 1  percent predicted was 82.60% ± 13.54% vs 105.83% ± 13.12% (P < .001), and the lung clearance index was 7.67 ± 1.02 vs 7.46 ± 0.70","['Adolescents', 'patients with bronchopulmonary dysplasia', 'Sixty-four adolescents aged 15.76 ± 1.52 years were included: 46 in the study group (17 PG and 29 NPG) and 18 in the control group', 'Extremely Premature Birth', 'survivors of extreme prematurity (<29\xa0weeks gestation) at 13 to 18 years of age (study group']","['palivizumab immunization (nonpalivizumab group [NPG', 'palivizumab immunization and extreme prematurity (<29\xa0weeks gestation', 'Palivizumab']","['respiratory symptoms and pulmonary function at adolescence', 'lung clearance index', 'Airway hyperreactivity', 'bronchodilator response', 'mean provocative concentration', 'lung function at adolescence', 'wheezing episodes, inhaler use, and hospitalizations']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0068260', 'cui_str': 'N-palmitoylgalactosylsphingosine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0672596', 'cui_str': 'palivizumab'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0068260', 'cui_str': 'N-palmitoylgalactosylsphingosine'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0231990', 'cui_str': 'Lung clearance index'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",64.0,0.149305,"For the study group compared with the control group, FEV 1  percent predicted was 82.60% ± 13.54% vs 105.83% ± 13.12% (P < .001), and the lung clearance index was 7.67 ± 1.02 vs 7.46 ± 0.70","[{'ForeName': 'Nofar', 'Initials': 'N', 'LastName': 'Amitai', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Stafler', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv.""}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Blau', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv.""}, {'ForeName': 'Eytan', 'Initials': 'E', 'LastName': 'Kaplan', 'Affiliation': ""Pediatric Intensive Care Unit, Schneider Children's Medical Center of Israel, Petah Tikva; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv.""}, {'ForeName': 'Huda', 'Initials': 'H', 'LastName': 'Mussaffi', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv.""}, {'ForeName': 'Hagit', 'Initials': 'H', 'LastName': 'Levine', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv.""}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Steuer', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva.""}, {'ForeName': 'Ephraim', 'Initials': 'E', 'LastName': 'Bar-Yishay', 'Affiliation': 'Faculty of Health Sciences, Ben Gurion University of the Negev, Beer Sheba, Israel.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Klinger', 'Affiliation': ""Neonatal Intensive Care Unit, Schneider Children's Medical Center of Israel, Petah Tikva; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv.""}, {'ForeName': 'Meir', 'Initials': 'M', 'LastName': 'Mei-Zahav', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv.""}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Prais', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv. Electronic address: prais@tauex.tau.ac.il.""}]",Chest,['10.1016/j.chest.2020.02.075']
587,32409981,Intravenous Tramadol is Effective in the Management of Postoperative Pain Following Abdominoplasty: A Three-Arm Randomized Placebo- and Active-Controlled Trial.,"BACKGROUND AND OBJECTIVE


Oral tramadol, an atypical opioid approved in the United States (US) since 1995 and a Schedule IV controlled substance, has less abuse liability compared to Schedule II conventional opioids. Intravenous (IV) tramadol is not available in the US, but has the potential to fill a gap between non-opioid medications and conventional opioids for treatment of acute pain. This study evaluates IV tramadol in the management of postoperative pain compared to placebo and standard-of-care active control.
METHODS


A phase 3, multicenter, double-blind, three-arm, randomized, placebo- and active-controlled, multiple-dose, parallel-group study was conducted to evaluate the efficacy and safety of 50 mg IV tramadol versus placebo and 4 mg IV morphine over 48 h in patients with postoperative pain following abdominoplasty surgery.
RESULTS


IV tramadol was statistically superior (p < 0.05) to placebo and comparable to IV morphine for the primary and all key secondary efficacy outcomes and demonstrated numerically lower rates for the incidence of most common treatment-emergent adverse events (TEAEs) compared to morphine. No unexpected findings were observed for TEAEs, laboratory tests, vital signs, or electrocardiograms (ECGs). Over 90% of patients completed the study.
CONCLUSION


The study demonstrated that IV tramadol 50 mg is highly effective in the management of postoperative pain following abdominoplasty. The consistency of effects between tramadol and morphine (as compared to placebo) for primary and key secondary endpoints validates the efficacy of tramadol observed. The study also provided direct evidence of improved tolerability of IV tramadol over a standard-of-care conventional Schedule II opioid. IV tramadol may become a useful option in patients where exposure to conventional opioids is not desired.",2020,"RESULTS


IV tramadol was statistically superior (p < 0.05) to placebo and comparable to IV morphine for the primary and all key secondary efficacy outcomes and demonstrated numerically lower rates for the incidence of most common treatment-emergent adverse events (TEAEs) compared to morphine.",['patients with postoperative pain following abdominoplasty surgery'],"['Placebo', 'IV tramadol', 'placebo and standard-of-care active control', 'morphine', 'Abdominoplasty', 'tramadol', '50\xa0mg IV tramadol versus placebo and 4\xa0mg IV morphine', 'Intravenous Tramadol', 'Intravenous (IV) tramadol', 'tramadol and morphine', 'placebo']","['Postoperative Pain', 'postoperative pain', 'TEAEs, laboratory tests, vital signs, or electrocardiograms (ECGs', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0198542', 'cui_str': 'Repair of abdominal wall'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0198542', 'cui_str': 'Repair of abdominal wall'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.353103,"RESULTS


IV tramadol was statistically superior (p < 0.05) to placebo and comparable to IV morphine for the primary and all key secondary efficacy outcomes and demonstrated numerically lower rates for the incidence of most common treatment-emergent adverse events (TEAEs) compared to morphine.","[{'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Minkowitz', 'Affiliation': 'Clinical Investigation, HD Research, LLC, Bellaire, TX, USA.'}, {'ForeName': 'Hernan', 'Initials': 'H', 'LastName': 'Salazar', 'Affiliation': 'Clinical Investigation, Endeavor Clinical Trials, HD, San Antonio, TX, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leiman', 'Affiliation': 'Clinical Investigation, HD Research, LLC, Bellaire, TX, USA.'}, {'ForeName': 'Daneshvari', 'Initials': 'D', 'LastName': 'Solanki', 'Affiliation': 'Clinical Investigation, HD Research, LLC, Bellaire, TX, USA.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Clinical Research, Avenue Therapeutics, 1140 Avenue of the Americas, 9th Floor, New York, NY, 10036, USA. llu@avenuetx.com.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Reines', 'Affiliation': 'Clinical Research, Avenue Therapeutics, 1140 Avenue of the Americas, 9th Floor, New York, NY, 10036, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ryan', 'Affiliation': 'Clinical Research, Avenue Therapeutics, 1140 Avenue of the Americas, 9th Floor, New York, NY, 10036, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Harnett', 'Affiliation': 'Clinical Research, Avenue Therapeutics, 1140 Avenue of the Americas, 9th Floor, New York, NY, 10036, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Singla', 'Affiliation': 'Clinical Investigation, Lotus Clinical Research, LLC, Pasadena, CA, USA.'}]",Drugs in R&D,['10.1007/s40268-020-00309-0']
588,31793398,Improving the Efficiency of Randomized Trials: The DYNAGITO Example.,"A traditional principle of the randomized controlled trial is that the p-value comparing treatment groups should be computed from the simple crude data. This assumes that the size of the study is sufficiently large for an accurate and precise estimation of the difference between groups. There are situations where the accuracy and precision of the study can be improved by statistical adjustment for baseline covariates, including when the outcome is continuous and available at baseline. The European Medicines Agency (EMA) and the Food and Drug Administration (FDA) recommend covariate adjustment in trials as a tool to improve the efficiency of the analysis and to avoid conditional bias from chance covariate imbalance. The recent DYNAGITO randomized controlled trial compared the effectiveness of the single inhaler tiotropium-olodaterol combination for the treatment of COPD with tiotropium alone in reducing the rate of exacerbations over 52 weeks. The pre-specified crude analysis produced a rate ratio of 0.93 (p-value > 0.01, not significant) comparing the tiotropium-olodaterol combination with tiotropium alone. However, a sensitivity analysis adjusted for the baseline rate of exacerbations and other factors produced a rate ratio of 0.89 (p-value 0.001, significant). The DYNAGITO trial is an example where statistical adjustment was justified but not used. Future trials of COPD therapy could be designed more efficiently, be made less costly, while improving the accuracy and precision of their data and the resulting conclusions.",2020,"The pre-specified crude analysis produced a rate ratio of 0.93 (p-value > 0.01, not significant) comparing the tiotropium-olodaterol combination with tiotropium alone.",[],"['COPD therapy', 'tiotropium-olodaterol combination', 'tiotropium']",['rate of exacerbations'],[],"[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4032878', 'cui_str': 'olodaterol / tiotropium'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}]",[],,0.219097,"The pre-specified crude analysis produced a rate ratio of 0.93 (p-value > 0.01, not significant) comparing the tiotropium-olodaterol combination with tiotropium alone.","[{'ForeName': 'Samy', 'Initials': 'S', 'LastName': 'Suissa', 'Affiliation': 'Centre for Clinical Epidemiology, Jewish General Hospital, Department of Epidemiology and Biostatistics, McGill University, Montreal, QC, Canada.'}]",COPD,['10.1080/15412555.2019.1698020']
589,31209957,Periprostatic nerve block alone versus combined with perineal pudendal nerve block or intrarectal local anesthesia during transrectal ultrasound-guided prostate biopsy: A prospective randomized controlled trial.,"OBJECTIVES


To compare the efficacy, safety and cost of combinations of perineal pudendal nerve block + periprostatic nerve block and intrarectal local anesthesia + periprostatic nerve block with the standard technique (periprostatic nerve block).
METHODS


The study was designed as a randomized prospective controlled trial. Patients with elevated serum prostate-specific antigen values (prostate-specific antigen ≥4 ng/mL) and/or abnormal digital rectal examination findings were included in the study. Patients with anorectal diseases, chronic prostatitis, previous history of prostate biopsy and anorectal surgery were excluded from the study. A total of 148 patients (group 1 [periprostatic nerve block], n = 48; group 2 [intrarectal local anesthesia + periprostatic nerve block], n = 51; group 3 [perineal pudendal nerve block + periprostatic nerve block], n = 49) were included in the final analysis. Pain during insertion and manipulation of the transrectal ultrasound probe was recorded as visual analog scale 1, pain during penetration of the biopsy needle into the prostate and sampling was recorded as visual analog scale 2, and pain during the entire procedure recorded as visual analog scale 3.
RESULTS


The mean visual analog scale 1 score was significantly lower in group 3, when compared with group 1 and group 2 (P < 0.001). There was no significant difference between the groups in terms of the mean visual analog scale 2 score. The mean visual analog scale 3 score was significantly lower in group 3 when compared with other groups (P < 0.001). The total cost for transrectal ultrasound-guided biopsy in the intrarectal local anesthesia + periprostatic nerve block group was significantly higher than the other two groups.
CONCLUSIONS


The combination of perineal pudendal nerve block and periprostatic nerve block provides more effective pain control than intrarectal local anesthesia plus periprostatic nerve block and periprostatic nerve block alone, with similar complication rates and without increasing cost.",2019,"The mean visual analog scale 1 score was significantly lower in group 3, when compared with group 1 and group 2 (P < 0.001).","['Patients with anorectal diseases, chronic prostatitis, previous history of prostate biopsy and anorectal surgery were excluded from the study', '148 patients (group\xa01 [periprostatic nerve block], n = 48; group\xa02 ', 'Patients with elevated serum prostate-specific antigen values (prostate-specific antigen']","['Periprostatic nerve block alone versus combined with perineal pudendal nerve block or intrarectal local anesthesia', 'intrarectal local anesthesia\xa0+\xa0periprostatic nerve block], n = 51; group\xa03 [perineal pudendal nerve block\xa0+\xa0periprostatic nerve block', 'perineal pudendal nerve block and periprostatic nerve block', 'perineal pudendal nerve block\xa0+\xa0periprostatic nerve block and intrarectal local anesthesia\xa0+\xa0periprostatic nerve block', 'transrectal ultrasound-guided prostate biopsy']","['mean visual analog scale', 'Pain', 'mean visual analog scale\xa03 score', 'mean visual analog scale\xa01 score', 'total cost for transrectal ultrasound-guided biopsy', 'efficacy, safety and cost']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0687707', 'cui_str': 'Anorectal Disorders'}, {'cui': 'C0085696', 'cui_str': 'Chronic prostatitis (disorder)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]","[{'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0031066', 'cui_str': 'Perineum'}, {'cui': 'C0228959', 'cui_str': 'Pudendal Nerve'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",148.0,0.10246,"The mean visual analog scale 1 score was significantly lower in group 3, when compared with group 1 and group 2 (P < 0.001).","[{'ForeName': 'Rahmi', 'Initials': 'R', 'LastName': 'Aslan', 'Affiliation': 'Department of Urology, Yuzuncu Yil University Medical Faculty, Van, Turkey.'}, {'ForeName': 'Akif', 'Initials': 'A', 'LastName': 'Erbin', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Sebahattin', 'Initials': 'S', 'LastName': 'Celik', 'Affiliation': 'Department of General Surgery, Yuzuncu Yil University Medical Faculty, Van, Turkey.'}, {'ForeName': 'Burak', 'Initials': 'B', 'LastName': 'Ucpinar', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Recep', 'Initials': 'R', 'LastName': 'Eryilmaz', 'Affiliation': 'Department of Urology, Yuzuncu Yil University Medical Faculty, Van, Turkey.'}, {'ForeName': 'Kerem', 'Initials': 'K', 'LastName': 'Taken', 'Affiliation': 'Department of Urology, Yuzuncu Yil University Medical Faculty, Van, Turkey.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14036']
590,31270429,Prevention of obesity in toddlers (PROBIT): a randomised clinical trial of responsive feeding promotion from birth to 24 months.,"INTRODUCTION


The aims of the PROBIT trial (clinicaltrials.gov: NCT03131284) were to prevent overweight or obesity occurring at two years of life, and improve feeding patterns during infancy.
METHODS


The trial compared 252 northern Italian newborns whose paediatricians offered their parents an educational programme from the child's birth to the age of two years (intervention arm) with 216 newborns whose parents did not undergo the programme (control arm). This sample size was 80% powerful to detect, with a 0.05 α error, a 40% lower prevalence of overweight/obesity and a 57% lower prevalence of obesity in the intervention arm. At each well visit, the parents of the children in the intervention arm were given oral and written information about protective behaviours, with particular emphasis on responsive feeding. Overweight and obesity at two years of age were, respectively, defined as a body mass index of more than the 85th and the 95th percentile in accordance with the WHO growth charts. The sample size had 80% power to detect a 40% lower prevalence of overweight/obesity and a 57% lower prevalence of obesity in the intervention arm.
RESULTS


At the age of two years, the prevalence of obesity in the intervention arm was 35% lower than among the controls, but the difference was not statistically significant (8.7% vs. 13.4%; p = 0.10) There was no difference in the prevalence of overweight/obesity between the groups (26.8% vs. 28.3%; p = 0.49). At the age of three months, a higher proportion of the infants in the intervention group were fed on demand (93% vs. 80%, p < 0.001).
CONCLUSIONS


The PROBIT trial failed to detect a significantly lower prevalence of obesity in the intervention arm, but did improve early feeding patterns. More powerful trials and meta-analyses are required to establish whether educating newborns' parents can decrease the prevalence of early obesity.",2019,"At the age of two years, the prevalence of obesity in the intervention arm was 35% lower than among the controls, but the difference was not statistically significant (8.7% vs. 13.4%; p = 0.10)","['Overweight and obesity at two years of age were, respectively, defined as a body mass index of more than the 85th and the 95th percentile in accordance with the WHO growth charts', 'obesity in toddlers (PROBIT', ""252 northern Italian newborns whose paediatricians offered their parents an educational programme from the child's birth to the age of two years (intervention arm) with 216 newborns whose parents did not undergo the programme (control arm""]",[],"['prevalence of obesity', 'prevalence of overweight/obesity']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C2718056', 'cui_str': 'Growth Charts'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0237433', 'cui_str': 'Pediatricians'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]",252.0,0.0318936,"At the age of two years, the prevalence of obesity in the intervention arm was 35% lower than among the controls, but the difference was not statistically significant (8.7% vs. 13.4%; p = 0.10)","[{'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Morandi', 'Affiliation': 'Pediatric Diabetes and Metabolic Disorders Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Tommasi', 'Affiliation': 'Pediatric Diabetes and Metabolic Disorders Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Soffiati', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Florinda', 'Initials': 'F', 'LastName': 'Destro', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Fontana', 'Affiliation': 'Pediatric Diabetes and Metabolic Disorders Unit, University Hospital of Verona, Verona, Italy. laura11fontana@gmail.com.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Grando', 'Affiliation': 'Dolomiti Local Health and Social Care Service, Belluno, Italy.'}, {'ForeName': 'Giustina', 'Initials': 'G', 'LastName': 'Simonetti', 'Affiliation': 'Dolomiti Local Health and Social Care Service, Belluno, Italy.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Bucolo', 'Affiliation': 'Euganea Local Health and Social Care Service, Padua, Italy.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Alberti', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Baraldi', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Antonietta', 'Initials': 'A', 'LastName': 'Chiriacò', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Ferrarese', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Graziana', 'Initials': 'G', 'LastName': 'Frignani', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Pasqualini', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Rossi', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Siciliano', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Zuccolo', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Giuliana', 'Initials': 'G', 'LastName': 'Matticchio', 'Affiliation': 'Berica Local Health and Social Care Service, Vicenza, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Vettori', 'Affiliation': 'Berica Local Health and Social Care Service, Vicenza, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Danieli', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Guarda', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Iuliano', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Raimo', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Sirpresi', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Trevisan', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Vinco', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Maffeis', 'Affiliation': 'Pediatric Diabetes and Metabolic Disorders Unit, University Hospital of Verona, Verona, Italy. Claudio.maffeis@univr.it.'}]",International journal of obesity (2005),['10.1038/s41366-019-0406-0']
591,29126661,A Supermarket Double-Dollar Incentive Program Increases Purchases of Fresh Fruits and Vegetables Among Low-Income Families With Children: The Healthy Double Study.,"OBJECTIVE


To carry out a pilot study to determine whether a supermarket double-dollar fruit and vegetable (F&V) incentive increases F&V purchases among low-income families.
DESIGN


Randomized controlled design. Purchases were tracked using a loyalty card that provided participants with a 5% discount on all purchases during a 3-month baseline period followed by the 4-month intervention.
SETTING


A supermarket in a low-income rural Maine community.
PARTICIPANTS


A total of 401 low-income and Supplemental Nutrition Assistance Program (SNAP) supermarket customers.
INTERVENTION


Same-day coupon at checkout for half-off eligible fresh, frozen, or canned F&V over 4 months.
MAIN OUTCOME MEASURE


Weekly spending in dollars on eligible F&V.
ANALYSIS


A linear model with random intercepts accounted for repeated transactions by individuals to estimate change in F&V spending per week from baseline to intervention. Secondary analyses examined changes among SNAP-eligible participants.
RESULTS


Coupons were redeemed among 53% of eligible baskets. Total weekly F&V spending increased in the intervention arm compared with control ($1.83; 95% confidence interval [CI], $0.29 to $3.88). The largest increase was for fresh F&V ($1.97; 95% CI, $0.49 to $3.44). Secondary analyses revealed greater increases in F&V spending among SNAP-eligible participants who redeemed coupons ($5.14; 95% CI, $1.93 to $8.34) than among non-SNAP eligible participants who redeemed coupons ($3.88; 95% CI, $1.67 to $6.08).
CONCLUSIONS AND IMPLICATIONS


A double-dollar pricing incentive increased F&V spending in a low-income community despite the moderate uptake of the coupon redemption. Customers who were eligible for SNAP saw the greatest F&V spending increases. Financial incentives for F&V are an effective strategy for food assistance programs to increase healthy purchases and improve dietary intake in low-income families.",2018,"Total weekly F&V spending increased in the intervention arm compared with control ($1.83; 95% confidence interval [CI], $0.29 to $3.88).","['A supermarket in a low-income rural Maine community', 'low-income families', 'Low-Income Families With Children', 'A total of 401 low-income and Supplemental Nutrition Assistance Program (SNAP) supermarket customers']",['supermarket double-dollar fruit and vegetable (F&V) incentive'],"['Total weekly F&V spending', 'fresh F&V', 'F&V spending', 'Weekly spending in dollars on eligible F&V']","[{'cui': 'C0557778', 'cui_str': 'Supermarket (environment)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0024497', 'cui_str': 'Maine'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3494397', 'cui_str': 'SNAP Program'}]","[{'cui': 'C0557778', 'cui_str': 'Supermarket (environment)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0562019', 'cui_str': 'dollar (qualifier value)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0562019', 'cui_str': 'dollar (qualifier value)'}]",401.0,0.226657,"Total weekly F&V spending increased in the intervention arm compared with control ($1.83; 95% confidence interval [CI], $0.29 to $3.88).","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Polacsek', 'Affiliation': 'Westbrook College of Health Professions, University of New England, Portland, ME. Electronic address: mpolacsek@une.edu.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Moran', 'Affiliation': 'Department of Nutrition, Harvard T. H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Anne N', 'Initials': 'AN', 'LastName': 'Thorndike', 'Affiliation': 'Harvard Medical School, Boston, MA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Boulos', 'Affiliation': 'Muskie School of Public Service, University of Southern Maine, Portland, ME.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Franckle', 'Affiliation': 'Department of Nutrition, Harvard T. H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Greene', 'Affiliation': 'Hannaford Supermarkets, Scarborough, ME.'}, {'ForeName': 'Dan J', 'Initials': 'DJ', 'LastName': 'Blue', 'Affiliation': 'Hannaford Supermarkets, Scarborough, ME.'}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Block', 'Affiliation': 'Department of Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Rimm', 'Affiliation': 'Department of Nutrition, Harvard T. H. Chan School of Public Health, Boston, MA.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2017.09.013']
592,31229240,Pexidartinib versus placebo for advanced tenosynovial giant cell tumour (ENLIVEN): a randomised phase 3 trial.,"BACKGROUND


Tenosynovial giant cell tumour (TGCT), a rare, locally aggressive neoplasm, overexpresses colony-stimulating factor 1 (CSF1). Surgery is standard with no approved systemic therapy. We aimed to evaluate pexidartinib, a CSF1 receptor inhibitor, in patients with TGCT to provide them with a viable systemic treatment option, especially in cases that are not amenable to surgical resection.
METHODS


This phase 3 randomised trial had two parts. Part one was a double-blind study in which patients with symptomatic, advanced TGCT for whom surgery was not recommended were randomly assigned via an integrated web response system (1:1) to the pexidartinib or placebo group. Individuals in the pexidartinib group received a loading dose of 1000 mg pexidartinib per day orally (400 mg morning; 600 mg evening) for the first 2 weeks, followed by 800 mg per day (400 mg twice a day) for 22 weeks. Part two was an open-label study of pexidartinib for all patients. The primary endpoint, assessed in all intention-to-treat patients, was overall response at week 25, and was centrally reviewed by RECIST, version 1.1. Safety was analysed in all patients who received at least one dose of the study drug. This study is registered with ClinicalTrials.gov, number NCT02371369.
FINDINGS


Between May 11, 2015, and Sept 30, 2016, of 174 patients assessed for eligibility, 120 patients were randomly assigned to, and received, pexidartinib (n=61) or placebo (n=59). There were 11 dropouts in the placebo group and nine in the pexidartinib group. Emergence of mixed or cholestatic hepatotoxicity caused the data monitoring committee to stop enrolment six patients short of target. The proportion of patients who achieved overall response was higher for pexidartinib than placebo at week 25 by RECIST (24 [39%] of 61 vs none of 59; absolute difference 39% [95% CI 27-53]; p<0·0001). Serious adverse events occurred in eight (13%) of 61 patients in the pexidartinib group and one (2%) of 59 patients in the placebo group. Hair colour changes (67%), fatigue (54%), aspartate aminotransferase increase (39%), nausea (38%), alanine aminotransferase increase (28%), and dysgeusia (25%) were the most frequent pexidartinib-associated adverse events. Three patients given pexidartinib had aminotransferase elevations three or more times the upper limit of normal with total bilirubin and alkaline phosphatase two or more times the upper limit of normal indicative of mixed or cholestatic hepatotoxicity, one lasting 7 months and confirmed by biopsy.
INTERPRETATION


Pexidartinib is the first systemic therapy to show a robust tumour response in TGCT with improved patient symptoms and functional outcomes; mixed or cholestatic hepatotoxicity is an identified risk. Pexidartinib could be considered as a potential treatment for TGCT associated with severe morbidity or functional limitations in cases not amenable to improvement with surgery.
FUNDING


Daiichi Sankyo.",2019,The proportion of patients who achieved overall response was higher for pexidartinib than placebo at week 25 by RECIST (24 [39%] of 61 vs none of 59; absolute difference 39% [95% CI 27-53]; p<0·0001).,"['patients with', 'Between May 11, 2015, and Sept 30, 2016, of 174 patients assessed for eligibility, 120 patients', 'patients with symptomatic, advanced TGCT for whom surgery was not recommended were randomly assigned via an integrated web response system (1:1) to the pexidartinib or', 'advanced tenosynovial giant cell tumour (ENLIVEN']","['Pexidartinib versus placebo', 'placebo', 'TGCT']","['fatigue', 'aminotransferase elevations', 'Hair colour changes', 'nausea', 'alanine aminotransferase increase', 'Emergence of mixed or cholestatic hepatotoxicity', 'aspartate aminotransferase increase', 'overall response', 'Serious adverse events', 'Safety', 'dysgeusia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1318543', 'cui_str': 'Giant Cell Tumor of Tendon Sheath'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0474378', 'cui_str': 'Hair color change (finding)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0151905', 'cui_str': 'SGPT increased'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C0151904', 'cui_str': 'Serum glutamic-oxaloacetic transaminase increased'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013378', 'cui_str': 'Taste, Distorted'}]",120.0,0.679653,The proportion of patients who achieved overall response was higher for pexidartinib than placebo at week 25 by RECIST (24 [39%] of 61 vs none of 59; absolute difference 39% [95% CI 27-53]; p<0·0001).,"[{'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Tap', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA. Electronic address: tapw@mskcc.org.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Palmerini', 'Affiliation': 'IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Jayesh', 'Initials': 'J', 'LastName': 'Desai', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Bauer', 'Affiliation': 'Sarcoma Center, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Centre Léon Bérard and Université Claude Bernard, Lyon, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Alcindor', 'Affiliation': 'McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Ganjoo', 'Affiliation': 'Stanford University Medical Center, Stanford, CA, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martín-Broto', 'Affiliation': 'Institute of Biomedicine of Sevilla, (IBIS, HUVR, CSIC, Universidad de Sevilla), Sevilla, Spain.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Ryan', 'Affiliation': 'Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Thomas', 'Affiliation': ""Chris O'Brien Lifehouse, Camperdown, NSW, Australia.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Peterfy', 'Affiliation': 'Spire Sciences, Boca Raton, FL, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Healey', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'van de Sande', 'Affiliation': 'Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'Gelhorn', 'Affiliation': 'Evidera, Bethesda, MD, USA.'}, {'ForeName': 'Dale E', 'Initials': 'DE', 'LastName': 'Shuster', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ, USA.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ, USA.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Yver', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ, USA.'}, {'ForeName': 'Henry H', 'Initials': 'HH', 'LastName': 'Hsu', 'Affiliation': 'Plexxikon, Berkeley, CA, USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Lin', 'Affiliation': 'Plexxikon, Berkeley, CA, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Tong-Starksen', 'Affiliation': 'Plexxikon, Berkeley, CA, USA.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Stacchiotti', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Wagner', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)30764-0']
593,31221502,"Multiple-dose clinical pharmacology of ACT-541468, a novel dual orexin receptor antagonist, following repeated-dose morning and evening administration.","ACT-541468 is a dual orexin receptor antagonist with sleep-promoting effects in humans. Following entry-into-humans, its pharmacokinetics (PK) including dose-proportionality and accumulation, pharmacodynamics (PD), safety, and tolerability following multiple-ascending oral dose (MAD) administration in the morning, and next-day residual effects after repeated evening administration were investigated in a double-blind, placebo-controlled, randomized study. 31 healthy male and female subjects in 3 dose-groups (10, 25, and 75 mg) received study drug in the morning for 5 days (MAD part), and 20 healthy subjects received 25 mg in the evening for 1 week (evening part). PK, PD (saccadic peak velocity (SPV), adaptive tracking, body sway, Bond and Lader visual analogue scales (VAS), Karolinska Sleepiness Scale (KSS), VAS Bowdle for assessment of psychedelic effects), Digit Symbol Substitution Test (DSST), and Simple Reaction Time Test (SRTT), safety, and tolerability were assessed. ACT-541468 was absorbed with a median t max  of 1.0-2.0 h across the 3 dose groups. The geometric mean elimination half-life (t ½ ) on Day 5 was between 5.6 and 8.5 h, and the exposure (area under the curve (AUC)) showed dose proportionality. No accumulation and no influence of sex on the multiple-dose PK parameters of ACT-541468 was observed. No effects were observed at 10 mg. Administration of 25 and 75 mg during the day showed clear dose-dependent effects on the PD parameters, while next-day effects were absent after evening administration of 25 mg. The drug was safe and well tolerated. In conclusion, multiple-dose PK/PD of ACT-541468 were compatible with a drug designated to treat insomnia.",2019,"The geometric mean elimination half-life (t ½ ) on Day 5 was between 5.6 and 8.5 h, and the exposure (area under the curve (AUC)) showed dose proportionality.","['31 healthy male and female subjects in 3 dose-groups (10, 25, and 75\u202fmg) received study drug in the morning for 5 days (MAD part), and 20 healthy subjects']",[],"['safe and well tolerated', 'PD parameters', 'pharmacokinetics (PK) including dose-proportionality and accumulation, pharmacodynamics (PD), safety, and tolerability', 'PK, PD (saccadic peak velocity (SPV), adaptive tracking, body sway, Bond and Lader visual analogue scales (VAS), Karolinska Sleepiness Scale (KSS), VAS Bowdle for assessment of psychedelic effects), Digit Symbol Substitution Test (DSST), and Simple Reaction Time Test (SRTT), safety, and tolerability']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0671759', 'cui_str': 'MAD'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],"[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0222045'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0018533', 'cui_str': 'Psychedelic Agents'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",31.0,0.0809589,"The geometric mean elimination half-life (t ½ ) on Day 5 was between 5.6 and 8.5 h, and the exposure (area under the curve (AUC)) showed dose proportionality.","[{'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Muehlan', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123 Allschwil, Switzerland. Electronic address: clemens.muehlan@idorsia.com.'}, {'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'Brooks', 'Affiliation': 'Centre for Human Drug Research (CHDR), Zernikedreef 8, 2333 CL Leiden, the Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Zuiker', 'Affiliation': 'Centre for Human Drug Research (CHDR), Zernikedreef 8, 2333 CL Leiden, the Netherlands.'}, {'ForeName': 'Joop', 'Initials': 'J', 'LastName': 'van Gerven', 'Affiliation': 'Centre for Human Drug Research (CHDR), Zernikedreef 8, 2333 CL Leiden, the Netherlands.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123 Allschwil, Switzerland.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2019.05.009']
594,31220256,"Controlling intestinal colonization of high-risk haematology patients with ESBL-producing Enterobacteriaceae: a randomized, placebo-controlled, multicentre, Phase II trial (CLEAR).","OBJECTIVES


We assessed the efficacy and safety of an oral antimicrobial regimen for short- and long-term intestinal eradication of ESBL-producing Escherichia coli and Klebsiella pneumoniae (ESBL-EC/KP) in immunocompromised patients.
METHODS


We performed a randomized (2:1), double-blind multicentre Phase II study in four haematology-oncology departments. Patients colonized with ESBL-EC/KP received a 7 day antimicrobial regimen of oral colistin (2 × 106 IU 4×/day), gentamicin (80 mg 4×/day) and fosfomycin (three administrations of 3 g every 72 h), or placebo. Faecal, throat and urine specimens were collected on day 0, 6 ± 2, 11 ± 2, 28 ± 4 and 42 ± 4 after treatment initiation, and the quantitative burden of ESBL-EC/KP, resistance genes and changes in intestinal microbiota were analysed. Clinicaltrials.gov: NCT01931592.
RESULTS


As the manufacture of colistin powder was suspended worldwide, the study was terminated prematurely. Overall, 29 (18 verum/11 placebo) out of 47 patients were enrolled. The short-term intestinal eradication was marginal at day 6 (verum group 15/18, 83.3% versus placebo 2/11, 18.2%; relative risk 4.58, 95% CI 1.29-16.33; Fisher's exact test P = 0.001) and not evident at later timepoints. Quantitative analysis showed a significant decrease of intestinal ESBL-EC/KP burden on day 6. Sustained intestinal eradication (day 28 + 42) was not achieved (verum, 38.9% versus placebo, 27.3%; P = 0.299). In the verum group, mcr-1 genes were detected in two faecal samples collected after treatment. Microbiome analysis showed a significant decrease in alpha diversity and a shift in beta diversity.
CONCLUSIONS


In this prematurely terminated study of a 7 day oral antimicrobial eradication regimen, short-term ESBL-EC/KP suppression was marginal, while an altered intestinal microbiota composition was clearly apparent.",2019,"The short-term intestinal eradication was marginal at day 6 (verum group 15/18, 83.3% versus placebo 2/11, 18.2%; relative risk 4.58, 95% CI 1.29-16.33; Fisher's exact test P = 0.001) and not evident at later timepoints.","['four haematology-oncology departments', 'high-risk haematology patients with ESBL-producing Enterobacteriaceae', '47 patients were enrolled', 'immunocompromised patients']","['placebo', 'gentamicin (80\u2009mg 4×/day) and fosfomycin', 'ESBL-producing Escherichia coli and Klebsiella pneumoniae (ESBL-EC/KP', 'oral colistin', 'oral antimicrobial regimen']","['intestinal ESBL-EC/KP burden', 'Faecal, throat and urine specimens', 'quantitative burden of ESBL-EC/KP, resistance genes and changes in intestinal microbiota', 'Sustained intestinal eradication', 'efficacy and safety', 'short-term intestinal eradication', 'intestinal microbiota composition', 'alpha diversity and a shift in beta diversity']","[{'cui': 'C1274119', 'cui_str': 'Haematology (specialty)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444096', 'cui_str': 'Extended spectrum beta-lactamase producing bacteria'}, {'cui': 'C0014346', 'cui_str': 'Coliform Bacilli'}, {'cui': 'C0085393', 'cui_str': 'Immunosuppressed Host'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017436', 'cui_str': 'Gentamicins'}, {'cui': 'C0016610', 'cui_str': 'Fosfomycin'}, {'cui': 'C1444096', 'cui_str': 'Extended spectrum beta-lactamase producing bacteria'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0001699', 'cui_str': 'Klebsiella pneumoniae'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}]","[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C1444096', 'cui_str': 'Extended spectrum beta-lactamase producing bacteria'}, {'cui': 'C0230069', 'cui_str': 'Structure of anterior portion of neck'}, {'cui': 'C0042037'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiome'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}]",47.0,0.534434,"The short-term intestinal eradication was marginal at day 6 (verum group 15/18, 83.3% versus placebo 2/11, 18.2%; relative risk 4.58, 95% CI 1.29-16.33; Fisher's exact test P = 0.001) and not evident at later timepoints.","[{'ForeName': 'Vassiliki', 'Initials': 'V', 'LastName': 'Dimitriou', 'Affiliation': 'Department I of Internal Medicine, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Lena M', 'Initials': 'LM', 'LastName': 'Biehl', 'Affiliation': 'Department I of Internal Medicine, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hamprecht', 'Affiliation': 'German Center for Infection Research (DZIF), partner site Bonn-Cologne, Cologne, Germany.'}, {'ForeName': 'Wichard', 'Initials': 'W', 'LastName': 'Vogel', 'Affiliation': 'Department of Oncology, Haematology, Immunology, Rheumatology and Pulmonology, Internal Medicine II, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Dörfel', 'Affiliation': 'Department of Oncology, Haematology, Immunology, Rheumatology and Pulmonology, Internal Medicine II, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Peter', 'Affiliation': 'Institute of Medical Microbiology and Hygiene, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Schafhausen', 'Affiliation': 'Department of Oncology and Haematology, Hubertus Wald Tumorzentrum/University Cancer Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Rohde', 'Affiliation': 'Institute for Medical Microbiology, Virology and Hygiene, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'von Lilienfeld-Toal', 'Affiliation': 'Department of Haematology and Medical Oncology, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Tilman E', 'Initials': 'TE', 'LastName': 'Klassert', 'Affiliation': 'Host Septomics Research Group, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Slickers', 'Affiliation': 'Abbott (Alere Technologies GmbH), Jena, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Ehricht', 'Affiliation': 'Center for Applied Research, InfectoGnostics Research Campus, Jena, Germany.'}, {'ForeName': 'Hortense', 'Initials': 'H', 'LastName': 'Slevogt', 'Affiliation': 'Host Septomics Research Group, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Hildegard', 'Initials': 'H', 'LastName': 'Christ', 'Affiliation': 'Institute of Medical Statistics, Informatics and Epidemiology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hellmich', 'Affiliation': 'Institute of Medical Statistics, Informatics and Epidemiology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Fedja', 'Initials': 'F', 'LastName': 'Farowski', 'Affiliation': 'Department I of Internal Medicine, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Tsakmaklis', 'Affiliation': 'Department I of Internal Medicine, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Higgins', 'Affiliation': 'German Center for Infection Research (DZIF), partner site Bonn-Cologne, Cologne, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Seifert', 'Affiliation': 'German Center for Infection Research (DZIF), partner site Bonn-Cologne, Cologne, Germany.'}, {'ForeName': 'Maria J G T', 'Initials': 'MJGT', 'LastName': 'Vehreschild', 'Affiliation': 'Department I of Internal Medicine, University Hospital of Cologne, Cologne, Germany.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz124']
595,31676280,Screening logs from a pilot randomized controlled trial of radical cystectomy versus chemoradiation therapy for muscle-invasive bladder cancer.,"INTRODUCTION AND OBJECTIVES


There is growing interest in a bladder preservation approach using chemoradiation therapy with transurethral resection of bladder tumor (TURBT), i.e., combined modality treatment (CMT), for muscle-invasive bladder cancer (MIBC). We have initiated a pilot study to determine feasibility of conducting a larger-scale clinical trial comparing CMT to radical cystectomy (RC) in patients with MIBC. Here we present the screening logs from the recruitment phase of this trial.
METHODS


Patients who were diagnosed to have MIBC after TURBT between April 2016 and August 2017 and considered to be candidates for surgery were enrolled in this prospective, single center, randomized controlled pilot feasibility trial and scheduled to undergo RC (with neoadjuvant chemotherapy if appropriate) or CMT.
RESULTS


Of 62 patients screened during the recruitment phase, only 5 were found to be suitable candidates for either treatment modality hence eligible for randomization. The reasons for exclusion were as follows: multifocal disease (n = 24, 40%), variant histology (n = 15, 25%), previous pelvic radiation (n = 6, 10%), severe lower urinary tract symptoms (n = 5, 8.3%), unwillingness to be enrolled (n = 8, 13.3%), and receipt of neoadjuvant chemotherapy (n = 2, 3.3%). One of the 5 eligible patients was randomized to CMT but was subsequently switched to RC because of a high tumor burden, 1 was randomized to RC, 2 were randomized to CMT but subsequently underwent TURBT and were considered ineligible because of extensive bladder disease, and 1 elected to undergo RC.
CONCLUSIONS


We identified many patients with MIBC over a period of 16 months. However, the number of patients eligible to receive chemotherapy and in whom cystectomy and radiation therapy were both valid options was not as high as previously reported in retrospective CMT series. Many patients were excluded after TURBT. Our preliminary data indicate that only a very small subset of patients with MIBC are ideal candidates for CMT. Further research is required to identify patients who are suitable for CMT.",2020,"One of the 5 eligible patients was randomized to CMT but was subsequently switched to RC because of a high tumor burden, 1 was randomized to RC, 2 were randomized to CMT but subsequently underwent TURBT and were considered ineligible because of extensive bladder disease, and 1 elected to undergo RC.
","['n\u202f=\u202f24, 40%), variant histology (n\u202f=\u202f15, 25%), previous pelvic radiation (n\u202f=\u202f6, 10%), severe lower urinary tract symptoms (n\u202f=\u202f5, 8.3%), unwillingness to be enrolled (n\u202f=\u202f8, 13.3%), and receipt of neoadjuvant chemotherapy (n\u202f=\u202f2, 3.3', 'muscle-invasive bladder cancer', '62 patients screened during the recruitment phase, only 5 were found to be suitable candidates for either treatment modality hence eligible for randomization', 'patients with MIBC', 'patients who are suitable for CMT', 'Patients who were diagnosed to have MIBC after TURBT between April 2016 and August 2017 and considered to be candidates for surgery']","['chemotherapy', 'CMT', 'CMT to radical cystectomy (RC', 'radical cystectomy versus chemoradiation therapy', 'RC (with neoadjuvant chemotherapy if appropriate) or CMT']",['multifocal disease'],"[{'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205292', 'cui_str': 'Multifocal (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.0721454,"One of the 5 eligible patients was randomized to CMT but was subsequently switched to RC because of a high tumor burden, 1 was randomized to RC, 2 were randomized to CMT but subsequently underwent TURBT and were considered ineligible because of extensive bladder disease, and 1 elected to undergo RC.
","[{'ForeName': 'Dharam', 'Initials': 'D', 'LastName': 'Kaushik', 'Affiliation': 'Department of Urology, University of Texas Health, San Antonio, TX. Electronic address: kaushik@uthscsa.edu.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Department of Radiation Oncology, University of Texas Health, San Antonio, TX.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Liss', 'Affiliation': 'Department of Urology, University of Texas Health, San Antonio, TX.'}, {'ForeName': 'Hanzhang', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, University of Texas Health, San Antonio, TX.'}, {'ForeName': 'Richa Priya', 'Initials': 'RP', 'LastName': 'Jha', 'Affiliation': 'Department of Urology, University of Texas Health, San Antonio, TX.'}, {'ForeName': 'Byeong Yeob', 'Initials': 'BY', 'LastName': 'Choi', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of Texas Health, San Antonio, TX.'}, {'ForeName': 'Deepak K', 'Initials': 'DK', 'LastName': 'Pruthi', 'Affiliation': 'Department of Urology, University of Texas Health, San Antonio, TX.'}, {'ForeName': 'Chul S', 'Initials': 'CS', 'LastName': 'Ha', 'Affiliation': 'Department of Radiation Oncology, University of Texas Health, San Antonio, TX.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Mansour', 'Affiliation': 'Department of Urology, University of Texas Health, San Antonio, TX.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Svatek', 'Affiliation': 'Department of Urology, University of Texas Health, San Antonio, TX.'}]",Urologic oncology,['10.1016/j.urolonc.2019.09.008']
596,31273686,Cost-Effectiveness of Three Alternative Boosted Protease Inhibitor-Based Second-Line Regimens in HIV-Infected Patients in West and Central Africa.,"BACKGROUND


While dolutegravir has been added by WHO as a preferred second-line option for the treatment of HIV infection, boosted protease inhibitor (bPI)-based regimens are still needed as alternative second-line options. Identifying optimal bPI-based second-line combinations is essential, given associated high costs and funding constraints in low- and middle-income countries. We assessed the cost-effectiveness of three alternative bPI-based second-line regimens in Burkina Faso, Cameroon and Senegal.
METHODS


We used data collected over 2010-2015 in the 2LADY trial/post-trial cohort. Patients with first-line antiretroviral therapy (ART) failure were randomly assigned to tenofovir/emtricitabine + lopinavir/ritonavir (TDF/FTC LPV/r; arm A), abacavir + didanosine + lopinavir/ritonavir (arm B), or tenofovir/emtricitabine + darunavir/ritonavir (arm C). Costs (US dollars, 2016), quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios were computed for each country over 24 months of follow-up and extrapolated to 5 years using a simulated patient-level Markov model. We assessed uncertainty using cost-effectiveness acceptability curves, scenarios and prices threshold analysis.
RESULTS


In each country, over 24 months, arm A was significantly less costly than arms B and C (incremental costs ranging from US$410-$US721 and US$468-US$546 for B and C vs A, respectively) and offered similar health benefits (incremental QALY: - 0.138 to 0.023 and - 0.179 to 0.028, respectively). Over 5 years, arm A remained the least costly, health benefits not being significantly different between arms. Compared with arms B and C, in each study country, Arm A had a ≥ 95% probability of being cost-effective for a large range of cost-effectiveness thresholds, irrespective of the scenario considered.
CONCLUSIONS


Using TDF/FTC LPV/r as a bPI-based second-line regimen provided the best economic value in the three study countries.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT00928187.",2020,"In each country, over 24 months, arm A was significantly less costly than arms B and C (incremental costs ranging from US$410-$US721 and US$468-US$546 for B and C vs A, respectively) and offered similar health benefits (incremental QALY: - 0.138 to 0.023 and - 0.179 to 0.028, respectively).","['Patients with first-line antiretroviral therapy (ART) failure', 'HIV-Infected Patients in West and Central Africa']","['tenofovir/emtricitabine\u2009+\u2009lopinavir/ritonavir (TDF/FTC LPV/r; arm A), abacavir\u2009+\u2009didanosine\u2009+\u2009lopinavir/ritonavir (arm B), or tenofovir/emtricitabine\u2009+\u2009darunavir/ritonavir (arm C', 'Three Alternative Boosted Protease Inhibitor-Based Second-Line Regimens']","['Cost-Effectiveness', 'Costs (US dollars, 2016), quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios', 'cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001740', 'cui_str': 'Africa, Central'}]","[{'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0939237', 'cui_str': 'lopinavir / Ritonavir'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0663655', 'cui_str': 'abacavir'}, {'cui': 'C0012133', 'cui_str': 'Didanosine'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C1268897', 'cui_str': 'Product containing protease inhibitor'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0562019', 'cui_str': 'dollar (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0967433,"In each country, over 24 months, arm A was significantly less costly than arms B and C (incremental costs ranging from US$410-$US721 and US$468-US$546 for B and C vs A, respectively) and offered similar health benefits (incremental QALY: - 0.138 to 0.023 and - 0.179 to 0.028, respectively).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Boyer', 'Affiliation': ""Aix Marseille Univ, INSERM, SESSTIM, IRD, Sciences Economiques et Sociales de la Santé et Traitement de l'Information Médicale, Marseille, France.""}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Nishimwe', 'Affiliation': ""Aix Marseille Univ, INSERM, SESSTIM, IRD, Sciences Economiques et Sociales de la Santé et Traitement de l'Information Médicale, Marseille, France. marie.nishimwe@inserm.fr.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sagaon-Teyssier', 'Affiliation': ""Aix Marseille Univ, INSERM, SESSTIM, IRD, Sciences Economiques et Sociales de la Santé et Traitement de l'Information Médicale, Marseille, France.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'March', 'Affiliation': 'UMI 233, Institut de Recherche pour le Développement (IRD), INSERM U1175, University of Montpellier, Montpellier, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Koulla-Shiro', 'Affiliation': 'Infectious Diseases Department, Yaoundé Central Hospital, Yaoundé, Cameroon.'}, {'ForeName': 'M-Q', 'Initials': 'MQ', 'LastName': 'Bousmah', 'Affiliation': ""Aix Marseille Univ, INSERM, SESSTIM, IRD, Sciences Economiques et Sociales de la Santé et Traitement de l'Information Médicale, Marseille, France.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Toby', 'Affiliation': 'Day Care Unit, Central Hospital, Yaoundé, Cameroon.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Mpoudi-Etame', 'Affiliation': 'Epidemiology and Infectious Diseases Service, Region 1 Military Hospital, Yaoundé, Cameroon.'}, {'ForeName': 'N F', 'Initials': 'NF', 'LastName': 'Ngom Gueye', 'Affiliation': 'Ambulatory Care Unit, Fann Hospital, Dakar, Senegal.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sawadogo', 'Affiliation': 'Day Care Unit, University Hospital Souro Sanou, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kouanfack', 'Affiliation': 'Yaoundé Central Hospital, Yaoundé, Cameroon.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ciaffi', 'Affiliation': 'UMI 233, Institut de Recherche pour le Développement (IRD), INSERM U1175, University of Montpellier, Montpellier, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Spire', 'Affiliation': ""Aix Marseille Univ, INSERM, SESSTIM, IRD, Sciences Economiques et Sociales de la Santé et Traitement de l'Information Médicale, Marseille, France.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Delaporte', 'Affiliation': 'UMI 233, Institut de Recherche pour le Développement (IRD), INSERM U1175, University of Montpellier, Montpellier, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PharmacoEconomics - open,['10.1007/s41669-019-0157-9']
597,31021278,Impact of Dietary Nitrate Supplementation on Executive Function During Hypoxic Exercise.,"We investigated the effects of 4-day dietary beetroot (BR) juice supplementation on executive function assessed by color-word Stroop task (CWST) in hypoxia (fraction of inspired oxygen [FiO 2 ] = 0.1395). Eight healthy young men performed 25-minute leg cycling exercise (target heart rate, 140 bpm) randomly with placebo (PL) juice or BR supplementation. The CWST was evaluated at resting hypoxic condition (after 30 minutes of hypoxic exposure) and at 15 minutes during exercise. During exercise, the correct response time in the CWST was significantly shortened compared with those at rest with no differences between PL and BR. The response accuracy in the CWST with BR was marginally lower than that with PL during exercise ( p  = 0.066). There were no significant differences in all physiological values, including pulmonary ventilation, arterial oxygen saturation, partial pressure of end-tidal carbon dioxide output, and tissue oxygenation in the left frontal lobe, assessed by near-infrared spectroscopy during exercise conditions involving PL and BR supplementation. These results suggest that moderate exercise in hypoxia partially improved executive function; however, 4-day dietary BR supplementation did not improve executive function during hypoxic exercise.",2019,"During exercise, the correct response time in the CWST was significantly shortened compared with those at rest with no differences between PL and BR.",['Eight healthy young men'],"['Dietary Nitrate Supplementation', '25-minute leg cycling exercise', 'placebo (PL) juice or BR supplementation', '4-day dietary beetroot (BR) juice supplementation']","['correct response time in the CWST', 'response accuracy', 'Executive Function', 'all physiological values, including pulmonary ventilation, arterial oxygen saturation, partial pressure of end-tidal carbon dioxide output, and tissue oxygenation in the left frontal lobe, assessed by near-infrared spectroscopy during exercise conditions involving PL and BR supplementation', 'executive function assessed by color-word Stroop task (CWST) in hypoxia (fraction of inspired oxygen', 'executive function']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0453112', 'cui_str': 'Beetroot (substance)'}]","[{'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0035213', 'cui_str': 'Respiratory Airflow'}, {'cui': 'C2711000', 'cui_str': 'SaO2 - Arterial oxygen saturation'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0429247', 'cui_str': 'Carbon dioxide output (observable entity)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0016733', 'cui_str': 'Frontal Cortex'}, {'cui': 'C0376519', 'cui_str': 'Spectrometry, Near-Infrared'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}]",8.0,0.0518115,"During exercise, the correct response time in the CWST was significantly shortened compared with those at rest with no differences between PL and BR.","[{'ForeName': 'Shohei', 'Initials': 'S', 'LastName': 'Dobashi', 'Affiliation': '1 Integrated Graduate School, Department of Medicine, Engineering, and Agricultural Sciences, University of Yamanashi, Kofu, Japan.'}, {'ForeName': 'Katsuhiro', 'Initials': 'K', 'LastName': 'Koyama', 'Affiliation': '3 Graduate School Department of Interdisciplinary Research, University of Yamanashi, Kofu, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Endo', 'Affiliation': '4 Division of Human Environmental Science, Mt. Fuji Research Institute, Fujiyoshida, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Kiuchi', 'Affiliation': '5 Graduate School, Department of Education, University of Yamanashi, Kofu, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Horiuchi', 'Affiliation': '4 Division of Human Environmental Science, Mt. Fuji Research Institute, Fujiyoshida, Japan.'}]",High altitude medicine & biology,['10.1089/ham.2018.0114']
598,31021265,Evaluation of 18-Week Whole-Body Vibration Training in Normobaric Hypoxia on Lower Extremity Muscle Strength in an Elderly Population.,"Therapeutic benefits of hypoxic training have been suggested for clinical populations, such as elderly who could suffer loss of lower limb muscle strength and higher risk of falling. This study investigated the effects of 18 weeks of whole-body vibration (WBV) training in normobaric hypoxia on the strength parameters of an elderly population. Thirty-one healthy elderly participants were randomly assigned to a hypoxic whole-body vibration group (HWBV;  n  = 10), normoxic whole-body vibration group (NWBV;  n  = 11), or control group ( n  = 10). The experimental groups received the same vibration treatment in a hypoxia chamber (HWBV: 16.1% fraction of inspired oxygen [FiO 2 ]; NWBV: 21.0% FiO 2 ). Isokinetic leg muscle strength was evaluated using a Biodex System-3 isokinetic dynamometer. Body composition was obtained with dual-energy X-ray absorptiometry. There were no significant differences between groups in either strength or body composition parameters. The NWBV group showed statistically significant improvements in the maximal strength of knee extensors, with a small effect size ( p  = 0.004;  d  = 0.54). No significant differences were found in any variable of the HWBV group. The combination of WBV training and exposure to normobaric cyclic hypoxia carried out in the present study did not have an effect on strength parameters in healthy elderly subjects.",2019,"The NWBV group showed statistically significant improvements in the maximal strength of knee extensors, with a small effect size ( p  = 0.004;  d  = 0.54).","['Elderly Population', 'Thirty-one healthy elderly participants', 'healthy elderly subjects', 'elderly population']","['hypoxic whole-body vibration group (HWBV;  n \u2009=\u200910), normoxic whole-body vibration group (NWBV;  n \u2009=\u200911), or control group', 'WBV training', 'inspired oxygen', '18-Week Whole-Body Vibration Training', 'whole-body vibration (WBV) training', 'same vibration treatment in a hypoxia chamber (HWBV', 'hypoxic training']","['Body composition', 'strength parameters', 'strength or body composition parameters', 'maximal strength of knee extensors', 'Isokinetic leg muscle strength']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment (regime/therapy)'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",31.0,0.00783893,"The NWBV group showed statistically significant improvements in the maximal strength of knee extensors, with a small effect size ( p  = 0.004;  d  = 0.54).","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Camacho-Cardenosa', 'Affiliation': '1 Faculty of Sport Science, University of Extremadura, Caceres, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Camacho-Cardenosa', 'Affiliation': '1 Faculty of Sport Science, University of Extremadura, Caceres, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Brazo-Sayavera', 'Affiliation': '2 Instituto Superior de Educación Física, Universidad de la República, Rivera, Uruguay.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Olcina', 'Affiliation': '1 Faculty of Sport Science, University of Extremadura, Caceres, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Tomas-Carus', 'Affiliation': '4 Departamento de Desporto e Saúde, Escola de Cie^ncia e Tecnologia, Universidade de Évora, Évora, Portugal.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Timón', 'Affiliation': '1 Faculty of Sport Science, University of Extremadura, Caceres, Spain.'}]",High altitude medicine & biology,['10.1089/ham.2018.0129']
599,31232076,Prehabilitation in patients undergoing pancreaticoduodenectomy: a randomized controlled trial.,"INTRODUCTION


prehabilitation has been proposed as an effective tool to prevent postoperative complications in patients undergoing major abdominal surgery. However, no studies have demonstrated its effectiveness in pancreatic surgical patients. The aim of this study was to assess the impact of prehabilitation on postoperative complications in patients undergoing a pancreaticoduodenectomy (PD).
METHODS


this was a randomized controlled trial. Eligible candidates who accepted to participate were randomized to the control (standard care) or intervention (standard care + prehabilitation) group. All patients with pancreatic or periampullary tumors who were candidates for pancreaticoduodenectomy were included. Patients who received neoadjuvant treatment were excluded. Prehabilitation covered three actions: a) nutritional support; b) control of diabetes and exocrine pancreatic insufficiency; and c) physical and respiratory training. The main study outcome was the proportion of patients who suffered postoperative complications. Secondary outcomes included the occurrence of specific complications (pancreatic leak and delayed gastric emptying) and hospital stay.
RESULTS


forty patients were included in the analysis. Twenty-two patients were randomized to the control arm and 18, to the intervention group. No statistically significant differences were observed in terms of overall and major complications between the prehabilitation and standard care groups. Pancreatic leak was not statistically different between the groups (11% vs 27%, p = 0.204). However, DGE was significantly lower in the prehabilitation group (5.6% vs 40.9% in the standard care group, p = 0.01).
CONCLUSION


prehabilitation did not reduce postoperative complications following pancreaticoduodenectomy. However, a reduction in DGE was observed. Further studies are needed to validate the role and the timing of prehabilitation in high-risk patients.",2019,No statistically significant differences were observed in terms of overall and major complications between the prehabilitation and standard care groups.,"['pancreatic surgical patients', 'Patients who received neoadjuvant treatment were excluded', 'All patients with pancreatic or periampullary tumors who were candidates for pancreaticoduodenectomy were included', 'patients undergoing a pancreaticoduodenectomy (PD', 'Eligible candidates who accepted to participate were randomized to the', 'patients undergoing major abdominal surgery', 'patients undergoing pancreaticoduodenectomy', 'forty patients were included in the analysis']",['control (standard care) or intervention (standard care + prehabilitation'],"['proportion of patients who suffered postoperative complications', 'postoperative complications', 'DGE', 'overall and major complications', 'occurrence of specific complications (pancreatic leak and delayed gastric emptying) and hospital stay', 'Pancreatic leak']","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant Treatment'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1504326', 'cui_str': 'Pancreatic leak'}, {'cui': 'C0740411', 'cui_str': 'Delayed gastric emptying (disorder)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",40.0,0.0989011,No statistically significant differences were observed in terms of overall and major complications between the prehabilitation and standard care groups.,"[{'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Ausania', 'Affiliation': 'Cirugía, CHUVI, España.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Senra', 'Affiliation': 'CHUVI.'}, {'ForeName': 'Reyes', 'Initials': 'R', 'LastName': 'Meléndez', 'Affiliation': 'CHUVI.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Caballeiro', 'Affiliation': 'CHUVI.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Ouviña', 'Affiliation': 'CHUVI.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Casal-Núñez', 'Affiliation': 'CHUVI.'}]",Revista espanola de enfermedades digestivas : organo oficial de la Sociedad Espanola de Patologia Digestiva,['10.17235/reed.2019.6182/2019']
600,30990099,Comparative randomized study on the sexual function and quality of life of women on contraceptive vaginal ring containing ethinylestradiol/etonogestrel 3.47/11.00mg or 2.7/11.7mg.,"The objective of the study was to evaluate the sexual function and quality of life (QoL) of healthy women on a new contraceptive vaginal ring (CVR) containing ethinylestradiol (EE) 3.47 mg and etonogestrel (ENG) 11.00 mg (study group) manufactured with a new polymer composition compared to EE 2.7 mg/ENG11.7 mg CVR (control group). Fifty-eight women were randomly allocated to the study group and the control group. The Female Sexual Function Index (FSFI), the Female Sexual Distress Scale (FSDS) and the Short Form-36, were used to assess sexual function, sexual distress and QoL, respectively. The study included two follow-ups, at 90 days and at 180 days. The control group reported more adverse events, mainly breakthrough bleeding, than the study group. The sexual function scores in the women in the study group improved with respect to those of the control group both at the 1st (FSFI,  p  = .009; FSDS,  p  = .001) and at the 2 nd  (FSFI,  p  = .001; FSDS,  p  = .002) follow-up. QoL of the study group improved at the 1 st  follow-up ( p  < .05) and 2 nd  ( p  < .01) follow-up. The control group improved their QoL at the 2nd follow-up ( p  < .01). The more gradual EE release of the new polymer composition could justify the behavioral differences of the women of the two groups.",2019,QoL of the study group improved at the 1 st  follow-up ( p  < .05) and 2 nd  ( p  < .01) follow-up.,"['healthy women on a new', 'Fifty-eight women']","['contraceptive vaginal ring (CVR) containing ethinylestradiol (EE) 3.47\u2009mg and etonogestrel (ENG', 'EE 2.7\u2009mg/ENG11.7\u2009mg CVR', 'contraceptive vaginal ring containing ethinylestradiol/etonogestrel']","['sexual function and quality of life (QoL', 'adverse events, mainly breakthrough bleeding', 'QoL', 'sexual function scores', 'sexual function and quality of life', 'Female Sexual Function Index (FSFI), the Female Sexual Distress Scale (FSDS']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C4517817', 'cui_str': '58'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0047683', 'cui_str': 'Etonogestrel'}, {'cui': 'C4517635', 'cui_str': '2.7'}]","[{'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0222045'}]",58.0,0.0198055,QoL of the study group improved at the 1 st  follow-up ( p  < .05) and 2 nd  ( p  < .01) follow-up.,"[{'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Caruso', 'Affiliation': 'Departemt of General Surgery and Medical Surgical Specialties, University of Catania-Italy Research Group for Sexology, Catania, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Panella', 'Affiliation': 'Departemt of General Surgery and Medical Surgical Specialties, University of Catania-Italy Research Group for Sexology, Catania, Italy.'}, {'ForeName': 'Giuliana', 'Initials': 'G', 'LastName': 'Giunta', 'Affiliation': 'Departemt of General Surgery and Medical Surgical Specialties, University of Catania-Italy Research Group for Sexology, Catania, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Matarazzo', 'Affiliation': 'Departemt of General Surgery and Medical Surgical Specialties, University of Catania-Italy Research Group for Sexology, Catania, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cianci', 'Affiliation': 'Departemt of General Surgery and Medical Surgical Specialties, University of Catania-Italy Research Group for Sexology, Catania, Italy.'}]",Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology,['10.1080/09513590.2019.1603290']
601,31784809,Randomized controlled trial comparing mini-sling with transobturator sling for the treatment of stress urinary incontinence.,"INTRODUCTION AND HYPOTHESIS


Stress urinary incontinence (SUI) is the involuntary loss of urine on effort and is a condition that negatively interferes with various aspects of a woman's life. This study aimed to demonstrate the non-inferiority of the less invasive single-incision mini-sling (SIMS) method in objective and subjective cures in relation to tension-free transobturator tape (TOT) in two analyses, per protocol and intention to treat, and secondarily to evaluate complications and quality of life.
METHODS


This study was a randomized controlled trial (RCT). Participants in this study included 105 women with a clinical diagnosis of stress predominant urinary incontinence and urodynamic results demonstrating SUI and absence of detrusor overactivity. Patients were evaluated pre- and postoperatively through anamnesis, physical examination, urinalysis, urine culture and susceptibility testing, simplified pad test, the Urinary Incontinence-Specific Quality of Life Instrument (I-QOL) and Urogenital Distress Inventory Short Form (UDI-6).
RESULTS


Regarding the objective cure, SIMS was non-inferior to TOT (p < 0.05). However, the same was not found for the subjective cure (p > 0.05). There were no differences in the complication rates (p > 0.05). However, in the TOT group, bladder perforation (2.4%), tape exposure (2.4%) and urinary retention occurred, lasting > 7 days (2.4%). In both groups, there was improvement in quality of life after surgery, without significant differences (p > 0.05).
CONCLUSIONS


The non-inferiority of SIMS in relation to TOT was only demonstrated in the objective cure. There were no significant differences between groups regarding complications and quality of life.",2020,"In both groups, there was improvement in quality of life after surgery, without significant differences (p > 0.05).
","['stress urinary incontinence', 'Stress urinary incontinence (SUI', '105 women with a clinical diagnosis of stress predominant urinary incontinence and urodynamic results demonstrating SUI and absence of detrusor overactivity']","['mini-sling with transobturator sling', 'TOT', 'invasive single-incision mini-sling (SIMS']","['urinary retention', 'anamnesis, physical examination, urinalysis, urine culture and susceptibility testing, simplified pad test, the Urinary Incontinence-Specific Quality of Life Instrument (I-QOL) and Urogenital Distress Inventory Short Form (UDI-6', 'quality of life', 'bladder perforation', 'complication rates', 'complications and quality of life', 'subjective cure', 'objective cure']","[{'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C1536696', 'cui_str': 'Overactivity'}]","[{'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C1141000', 'cui_str': 'Sled, device (physical object)'}, {'cui': 'C0441637', 'cui_str': 'Slinging'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}]","[{'cui': 'C0080274', 'cui_str': 'Urinary Retention'}, {'cui': 'C0021055', 'cui_str': 'Immunological Memory'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0430404', 'cui_str': 'Urine culture (procedure)'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0434133', 'cui_str': 'Perforation of bladder (disorder)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]",105.0,0.139802,"In both groups, there was improvement in quality of life after surgery, without significant differences (p > 0.05).
","[{'ForeName': 'Ana P', 'Initials': 'AP', 'LastName': 'Maturana', 'Affiliation': 'Department of Urogynecology and Vaginal Surgery within the Discipline of Gynecology, ABC Medical School, Av. Lauro Gomes, 2000-Vila Sacadura Cabral, Santo André, SP, 09060-650, Brazil. a.matura2@gmail.com.'}, {'ForeName': 'Claudia C', 'Initials': 'CC', 'LastName': 'Palos', 'Affiliation': 'Department of Urogynecology and Vaginal Surgery within the Discipline of Gynecology, ABC Medical School, Av. Lauro Gomes, 2000-Vila Sacadura Cabral, Santo André, SP, 09060-650, Brazil.'}, {'ForeName': 'Frederico R', 'Initials': 'FR', 'LastName': 'Ghersel', 'Affiliation': 'Department of Urogynecology and Vaginal Surgery within the Discipline of Gynecology, ABC Medical School, Av. Lauro Gomes, 2000-Vila Sacadura Cabral, Santo André, SP, 09060-650, Brazil.'}, {'ForeName': 'Cesar E', 'Initials': 'CE', 'LastName': 'Fernandes', 'Affiliation': 'Department of Urogynecology and Vaginal Surgery within the Discipline of Gynecology, ABC Medical School, Av. Lauro Gomes, 2000-Vila Sacadura Cabral, Santo André, SP, 09060-650, Brazil.'}, {'ForeName': 'Emerson', 'Initials': 'E', 'LastName': 'Oliveira', 'Affiliation': 'Department of Urogynecology and Vaginal Surgery within the Discipline of Gynecology, ABC Medical School, Av. Lauro Gomes, 2000-Vila Sacadura Cabral, Santo André, SP, 09060-650, Brazil.'}]",International urogynecology journal,['10.1007/s00192-019-04145-y']
602,31764989,"Sodium thiosulphate and progression of vascular calcification in end-stage renal disease patients: a double-blind, randomized, placebo-controlled study.","BACKGROUND


Sodium thiosulphate (NaTS) is mostly used in haemodialysis (HD) patients with calcific uraemic arteriolopathy. This double-blind, randomized, placebo-controlled study assessed the effect of NaTS on progression of cardiovascular calcifications in HD patients.
METHODS


From 65 screened patients, we recruited 60 patients with an abdominal aorta Agatston calcification score ≥100. Thirty patients were randomized to receive NaTS 25 g/1.73 m2 and 30 patients to receive 100 mL of 0.9% sodium chloride intravenously during the last 15 min of HD over a period of 6 months. The primary endpoint was the absolute change of the abdominal aortic calcification score.
RESULTS


The abdominal aortic calcification score and calcification volume of the abdominal aorta increased similarly in both treatment groups during the trial. As compared with the saline group, patients receiving NaTS exhibited a reduction of their iliac artery calcification score (-137 ± 641 versus 245  ± 755; P = 0.049), reduced pulse wave velocity (9.6  ± 2.7 versus 11.4 ± 3.6; P = 0.000) and a lower carotid intima-media thickness (0.77  ± 0.1 versus 0.83  ±  00.17; P = 0.033) and had better preservation of echocardiographic parameters of left ventricular hypertrophy. No patient of the NaTS group developed new cardiac valve calcifications during the trial as compared with 8 of 29 patients in the saline group. By univariate analysis, NaTS therapy was the only predictor of not developing new valvular calcifications. No adverse events possibly related to NaTS infusion were noted.
CONCLUSIONS


While NaTS failed to retard abdominal aortic calcification progress, it positively affected calcification progress in iliac arteries and heart valves as well as several other cardiovascular functional parameters.",2020,"As compared with the saline group, patients receiving NaTS exhibited a reduction of their iliac artery calcification score (-137 ± 641 versus 245  ± 755; P = 0.049), reduced pulse wave velocity (9.6  ± 2.7 versus 11.4 ± 3.6; P = 0.000) and a lower carotid intima-media thickness (0.77  ± 0.1 versus 0.83  ±  00.17; P = 0.033) and had better preservation of echocardiographic parameters of left ventricular hypertrophy.","['From 65 screened patients', 'end-stage renal disease patients', 'HD patients', 'Thirty patients', 'haemodialysis (HD) patients with calcific uraemic arteriolopathy', '60 patients with an abdominal aorta Agatston calcification score ≥100']","['NaTS', 'Sodium thiosulphate (NaTS', 'placebo', 'NaTS 25\u2009g/1.73\u2009m2 and 30 patients to receive 100\u2009mL of 0.9% sodium chloride', 'Sodium thiosulphate']","['lower carotid intima-media thickness', 'echocardiographic parameters of left ventricular hypertrophy', 'abdominal aortic calcification score and calcification volume of the abdominal aorta', 'reduction of their iliac artery calcification score', 'new cardiac valve calcifications', 'reduced pulse wave velocity', 'absolute change of the abdominal aortic calcification score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0003484', 'cui_str': 'Aorta, Abdominal'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0067787', 'cui_str': 'TalANAc'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0340279', 'cui_str': 'Ventricular hypertrophy (disorder)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1096249', 'cui_str': 'Aortic calcification'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0003484', 'cui_str': 'Aorta, Abdominal'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0020887', 'cui_str': 'Deep Circumflex Iliac Artery'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0018826', 'cui_str': 'Cardiac Valves'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",60.0,0.40465,"As compared with the saline group, patients receiving NaTS exhibited a reduction of their iliac artery calcification score (-137 ± 641 versus 245  ± 755; P = 0.049), reduced pulse wave velocity (9.6  ± 2.7 versus 11.4 ± 3.6; P = 0.000) and a lower carotid intima-media thickness (0.77  ± 0.1 versus 0.83  ±  00.17; P = 0.033) and had better preservation of echocardiographic parameters of left ventricular hypertrophy.","[{'ForeName': 'Petar', 'Initials': 'P', 'LastName': 'Djuric', 'Affiliation': 'Clinical Department for Nephrology, Zvezdara University Medical Center, Belgrade, Serbia.'}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Dimkovic', 'Affiliation': 'Clinical Department for Nephrology, Zvezdara University Medical Center, Belgrade, Serbia.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Schlieper', 'Affiliation': 'Division of Nephrology and Immunology, Rheinisch-Westfälische Technische Hochschule Aachen, Aachen, Germany.'}, {'ForeName': 'Zivka', 'Initials': 'Z', 'LastName': 'Djuric', 'Affiliation': 'Clinical Department for Nephrology, Zvezdara University Medical Center, Belgrade, Serbia.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Pantelic', 'Affiliation': 'Center for Radiology, Zvezdara University Medical Center, Belgrade, Serbia.'}, {'ForeName': 'Milica', 'Initials': 'M', 'LastName': 'Mitrovic', 'Affiliation': 'Center for Radiology and Magnetic Resonance Imaging, Clinical Center of Serbia, Beograd, Serbia.'}, {'ForeName': 'Aleksandar', 'Initials': 'A', 'LastName': 'Jankovic', 'Affiliation': 'Clinical Department for Nephrology, Zvezdara University Medical Center, Belgrade, Serbia.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Milanov', 'Affiliation': 'Clinical Department for Cardiology, Zvezdara University Medical Center, Belgrade, Serbia.'}, {'ForeName': 'Jovana', 'Initials': 'J', 'LastName': 'Kuzmanovic Pficer', 'Affiliation': 'Department for Medical Statistics and Informatics, School of Dental Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Floege', 'Affiliation': 'Division of Nephrology and Immunology, Rheinisch-Westfälische Technische Hochschule Aachen, Aachen, Germany.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz204']
603,31130005,A Pilot Study of a Sleep Intervention Delivered through Group Prenatal Care to Overweight and Obese Women.,"OBJECTIVES


We sought to investigate the feasibility of a behavioral sleep intervention for insomnia, delivered through group prenatal care and the relationship of this intervention to improvements in insomnia symptoms and sleep quality.
PARTICIPANTS


Women receiving prenatal care and reporting a pre-pregnancy BMI of ≥25 kg/m 2  and sleep duration of <6.5 h per night.
METHODS


Participants were randomized to group prenatal care or group prenatal care with a behavioral sleep intervention, adapted from cognitive behavioral therapy for insomnia (CBT-I) online program Go! to Sleep®. In the second trimester (T1), late third trimester (T2) and 6-8 weeks postpartum (T3) study assessments were completed including the  Insomnia Severity Index, Pittsburgh Sleep Quality Index , fasting glucose and insulin and weight and height. Data were analyzed using independent samples t-tests, chi-square tests, correlations, and two-way repeated measures ANOVA where appropriate. P < .05 was set as the level of significance.
RESULTS


From May 2014 to April 2015, 311 women were evaluated for inclusion and 53 women were randomized to participate (27 intervention; 26 control), 15% were lost to follow up. The intervention group had lower third trimester and postpartum levels of moderate to severe insomnia (T2 50.0% vs 85.0% (p = .018) and T3 13.6% vs 52.4% (p-.008)) and mean insomnia severity scores (T2 (14.7 (±6.6) vs 19.3 (± 6.0) p = .02) and T3 (9.7 (±5.4) vs 15.1(±7.2) p = .01)) when compared to the control group.
CONCLUSION


A randomized controlled trial of a behavioral sleep intervention for insomnia delivered through group prenatal care led to improvements in insomnia symptoms.",2020,The intervention group had lower third trimester and postpartum levels of moderate to severe insomnia (T2 50.0% vs 85.0% (p = .018) and T3 13.6% vs 52.4% (p-.008)) and mean insomnia severity scores (T2 (14.7 (±6.6) vs 19.3 (± 6.0) p = .02) and T3 (9.7 (±5.4) vs 15.1(±7.2),"['Women receiving prenatal care and reporting a pre-pregnancy BMI of ≥25 kg/m 2  and sleep duration of <6.5 h per night', 'Participants ', 'to Overweight and Obese Women', 'From May 2014 to April 2015, 311 women were evaluated for inclusion and 53 women']","['prenatal care or group prenatal care with a behavioral sleep intervention, adapted from cognitive behavioral therapy for insomnia (CBT-I) online program Go! to Sleep®', 'behavioral sleep intervention', 'Sleep Intervention Delivered through Group Prenatal Care']","['lower third trimester and postpartum levels of moderate to severe insomnia', 'mean insomnia severity scores', 'Insomnia Severity Index, Pittsburgh Sleep Quality Index , fasting glucose and insulin and weight and height', 'insomnia symptoms and sleep quality', 'insomnia symptoms']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0442051', 'cui_str': 'Lower third (qualifier value)'}, {'cui': 'C0032982', 'cui_str': 'Pregnancy Trimesters'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",311.0,0.0605809,The intervention group had lower third trimester and postpartum levels of moderate to severe insomnia (T2 50.0% vs 85.0% (p = .018) and T3 13.6% vs 52.4% (p-.008)) and mean insomnia severity scores (T2 (14.7 (±6.6) vs 19.3 (± 6.0) p = .02) and T3 (9.7 (±5.4) vs 15.1(±7.2),"[{'ForeName': 'Mary Ashley', 'Initials': 'MA', 'LastName': 'Cain', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, University of South Florida Morsani College of Medicine , Tampa, Florida, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Brumley', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of midwifery, University of South Florida Morsani College of Medicine , Tampa, Florida, USA.'}, {'ForeName': 'Adetola', 'Initials': 'A', 'LastName': 'Louis-Jacques', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, University of South Florida Morsani College of Medicine , Tampa, Florida, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Drerup', 'Affiliation': 'Department of sleep disorders, Cleveland Clinic Sleep Disorders Center , Cleveland, OH.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Stern', 'Affiliation': 'Department of Child and Family Studies, University of South Florida , Tampa.'}, {'ForeName': 'Judette M', 'Initials': 'JM', 'LastName': 'Louis', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, University of South Florida Morsani College of Medicine , Tampa, Florida, USA.'}]",Behavioral sleep medicine,['10.1080/15402002.2019.1613995']
604,31174708,Is fidelity to motivational interviewing associated with alcohol outcomes in treatment-seeking 60+ year-old citizens?,"BACKGROUND


Part of the variability in treatment outcomes for Motivational Interviewing (MI) may be explained by differences in the fidelity to MI. The Motivational Interviewing Treatment Integrity manual version 4 (MITI 4) is an improved measure of fidelity to elements of MI. It is not known whether the fidelity to MI, as measured by the MITI 4, is related to treatment outcome.
OBJECTIVES


To examine whether fidelity to MI is associated with alcohol use outcomes - predictive validity of the MITI 4.
METHOD


Twenty percent of the recorded sessions at the Danish sites of the Elderly Study were randomly drawn and coded for fidelity to MI with the MITI 4. The Elderly Study was an international, randomized controlled trial, in which people 60 years or older with Alcohol Use Disorders received either four weeks of Motivational Enhancement Therapy (MET) or four weeks of MET combined with up to eight additional sessions of the Community Reinforcement Approach- Senior (MET+CRA-S). Elements of MI and summary scores of the MITI 4 were used as predictors in a mixed effects regression analysis. Treatment outcomes were use of alcohol and consequences of drinking at 26-weeks follow-up.
RESULTS


In total, 423 sessions representing 238 participants were randomly drawn and coded for fidelity to MI. Mean values of the treatment elements indicated high fidelity to MI, with higher fidelity to MI in the MET sessions, as compared to CRA-S sessions. None of the predictors in the multilevel model analyses were associated with outcome at follow-up. Exploratory analysis indicated reverse associations between one measure of MI-fidelity and drinking outcomes in the combined treatment (CRAS).
CONCLUSION


The fidelity of the MI intervention, received by participants in this study, did not predict better treatment outcomes. MI may be less effective in populations which are already committed to change behavior. As expected and validating for the MITI 4, fidelity to MI-elements was lower in the combination of MI with other treatment approaches. Additionally, the timing of MI in these combined settings might be important for effectiveness.",2019,"It is not known whether the fidelity to MI, as measured by the MITI 4, is related to treatment outcome.
","['In total, 423 sessions representing 238 participants were randomly drawn and coded for fidelity to MI', 'Twenty percent of the recorded sessions at the Danish sites of the Elderly Study were randomly drawn and coded for fidelity to MI with the MITI 4', 'people 60\u202fyears or older with Alcohol Use Disorders received either four weeks of']","['Motivational Interviewing (MI', 'Motivational Enhancement Therapy (MET) or four weeks of MET combined with up to eight additional sessions of the Community Reinforcement Approach- Senior (MET+CRA-S']","['alcohol and consequences of drinking at 26-weeks follow-up', 'MI-fidelity and drinking outcomes']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C2945843', 'cui_str': 'Site of (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0686907', 'cui_str': 'Consequence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}]",238.0,0.019676,"It is not known whether the fidelity to MI, as measured by the MITI 4, is related to treatment outcome.
","[{'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Kramer Schmidt', 'Affiliation': 'Unit of Clinical Alcohol Research, University of Southern Denmark, J.B. Winsløwsvej 18, entrance 220B, 5000 Odense C, Denmark. Electronic address: lkramer@health.sdu.dk.'}, {'ForeName': 'Theresa B', 'Initials': 'TB', 'LastName': 'Moyers', 'Affiliation': 'Center on Alcoholism, Substance Abuse, and Addictions, MSC11 6280, 1 University of New Mexico, Albuquerque, NM 87131, United States. Electronic address: tmoyers@unm.edu.'}, {'ForeName': 'Anette Søgaard', 'Initials': 'AS', 'LastName': 'Nielsen', 'Affiliation': 'Unit of Clinical Alcohol Research, University of Southern Denmark, J.B. Winsløwsvej 18, entrance 220B, 5000 Odense C, Denmark; OPEN Odense Patient data Explorative Network, Denmark. Electronic address: ansnielsen@health.sdu.dk.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Andersen', 'Affiliation': 'Unit of Clinical Alcohol Research, University of Southern Denmark, J.B. Winsløwsvej 18, entrance 220B, 5000 Odense C, Denmark; Department of Mental Health, Region of Southern Denmark, Denmark. Electronic address: Kjeld.andersen@rsyd.dk.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.03.004']
605,31174713,Treatment with injectable hydromorphone: Comparing retention in double blind and open label treatment periods.,"BACKGROUND


In a double-blind, non-inferiority randomized controlled trial injectable hydromorphone, a licensed short acting opioid analgesic, was shown to be as effective as diacetylmorphine for the treatment of severe opioid use disorder. An appropriate question is whether hydromorphone offered open-label can attract and retain patients.
METHODS


This is a retrospective study, using daily prescription data from the Crosstown Clinic in Vancouver, Canada. Treatment retention among participants who had the opportunity to receive open-label injectable hydromorphone for at least 90 consecutive days (n = 108) before having the choice of receiving open-label diacetylmorphine, was compared to their retention outcomes with double-blind injectable opioid agonist treatment (iOAT). McNemar tests analyzed differences in proportions; a conditional logistic model estimated exact odds ratios; Pairwise t-tests analyzed differences in total number of treatment days; and Kaplan-Meier curves and clustered log-rank tests compared time to first 30 continuous days without injectable treatment.
RESULTS


A total of 74 participants (68.5%) were retained in both open-label hydromorphone and double-blind iOAT. Open-label hydromorphone was not significantly associated with lower retention (OR = 0.5; 95% CI: 0.2, 1.1; p = .10). Participants attended a mean of 84.4 (SD = 15.8) days of iOAT in the trial and 80.5 (SD = 22.0) days in open-label hydromorphone (mean difference of -3.9; 95% CI = -8.9, 1.1). Kaplan-Meier curves and log-rank tests were not statistically significant.
CONCLUSION


As treatment with injectable hydromorphone expands across Canada, our study contributes in a unique manner by providing evidence that the high retention rates observed during the clinical trial were maintained when participants started open-label hydromorphone.",2019,"Open-label hydromorphone was not significantly associated with lower retention (OR = 0.5; 95% CI: 0.2, 1.1; p = .10).","['participants who had the opportunity to receive', 'Crosstown Clinic in Vancouver, Canada', 'A total of 74 participants (68.5%) were retained in both open-label', 'for at least 90 consecutive days (n\u202f=\u202f108) before having the choice of receiving']","['double-blind injectable opioid agonist treatment (iOAT', 'hydromorphone and double-blind iOAT', 'open-label diacetylmorphine', 'open-label injectable hydromorphone', 'diacetylmorphine', 'Open-label hydromorphone', 'hydromorphone']",['Kaplan-Meier curves and log-rank tests'],"[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}]","[{'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0011892', 'cui_str': 'diamorphine'}]","[{'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",74.0,0.449354,"Open-label hydromorphone was not significantly associated with lower retention (OR = 0.5; 95% CI: 0.2, 1.1; p = .10).","[{'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Oviedo-Joekes', 'Affiliation': ""Centre for Health Evaluation & Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575-1081 Burrard St., Vancouver, BC V6Z 1Y6, Canada; School of Population and Public Health, University of British Columbia, 2206 East Mall, Vancouver, BC V6T 1Z3, Canada. Electronic address: eugenia@cheos.ubc.ca.""}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Palis', 'Affiliation': ""Centre for Health Evaluation & Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575-1081 Burrard St., Vancouver, BC V6Z 1Y6, Canada; School of Population and Public Health, University of British Columbia, 2206 East Mall, Vancouver, BC V6T 1Z3, Canada.""}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Guh', 'Affiliation': ""Centre for Health Evaluation & Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575-1081 Burrard St., Vancouver, BC V6Z 1Y6, Canada.""}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Marchand', 'Affiliation': ""Centre for Health Evaluation & Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575-1081 Burrard St., Vancouver, BC V6Z 1Y6, Canada; School of Population and Public Health, University of British Columbia, 2206 East Mall, Vancouver, BC V6T 1Z3, Canada.""}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Brissette', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Hôpital Saint-Luc, CHUM Montréal, Montréal, QC H2X 3J4, Canada.""}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Harrison', 'Affiliation': 'Providence Health Care, Providence Crosstown Clinic, 84 West Hastings Street, Vancouver, BC V6B 1G6, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'MacDonald', 'Affiliation': 'Providence Health Care, Providence Crosstown Clinic, 84 West Hastings Street, Vancouver, BC V6B 1G6, Canada.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Lock', 'Affiliation': ""Centre for Health Evaluation & Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575-1081 Burrard St., Vancouver, BC V6Z 1Y6, Canada.""}, {'ForeName': 'Aslam H', 'Initials': 'AH', 'LastName': 'Anis', 'Affiliation': ""Centre for Health Evaluation & Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575-1081 Burrard St., Vancouver, BC V6Z 1Y6, Canada.""}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Marsh', 'Affiliation': 'Northern Ontario School of Medicine, 935 Ramsey Lake Road, Sudbury, ON P3E 2C6, Canada; Canadian Addiction Treatment Centres, 175 Commerce Valley West, Suite 300, Markham, Ontario L3T 7P6, Canada.'}, {'ForeName': 'Martin T', 'Initials': 'MT', 'LastName': 'Schechter', 'Affiliation': ""Centre for Health Evaluation & Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575-1081 Burrard St., Vancouver, BC V6Z 1Y6, Canada; School of Population and Public Health, University of British Columbia, 2206 East Mall, Vancouver, BC V6T 1Z3, Canada.""}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.03.012']
606,31754961,Randomized crossover study of tongue-retaining device and positive airway pressure for obstructive sleep apnea.,"PURPOSE


To compare the efficacy of tongue-retaining device (TRD) versus continuous positive airway pressure (CPAP) for treatment of obstructive sleep apnea (OSA).
STUDY DESIGN


Randomized crossover study.
SUBJECTS AND METHODS


Thirty-six patients with a mean age of 52.7 ± 10.6 years were enrolled. Inclusion criteria were age ≥ 18 years, apnea-hypopnea index (AHI) ≥ 5 events/h, and minimum oxygen saturation (SO 2 ) ≥ 70% from polysomnography (PSG). Exclusion criteria were severe periodontal disease, unstable cardiopulmonary or neurological diseases, and/or total sleep time < 2 h. A 1-week wash-in period was followed by questionnaires and randomization into two groups: TRD/CPAP and CPAP/TRD (18 patients each). After 3 weeks of intervention, questionnaires were re-administered and WatchPAT was performed. After a 1-week wash-out period, patients were switched to the other treatment. Primary outcome was AHI. Secondary outcomes were SO 2 , Functional Outcomes of Sleep Questionnaire (FOSQ), and Epworth Sleepiness Scale (ESS) scores, treatment side effects, and adherence.
RESULTS


Nine patients withdrew, so 27 patients were included in the final analysis. Mean AHI decreased from 38.7 ± 24.0 to 2.5 ± 0.5 and 12.7 ± 2.6 events/h for CPAP and TRD, respectively (95% confidence interval of mean differences 4.65-15.62; p < 0.001). There was no significant difference in ESS and FOSQ scores between treatments. Common adverse effects were drooling, tongue numbness, and pain for TRD; and nasal blockage, mask compression, and difficult portability for CPAP.
CONCLUSIONS


CPAP was superior to TRD for resolving PSG parameters; however, both similarly improved QOL and daytime sleepiness. TRD might be considered a short-term alternative treatment for OSA.
TRIAL REGISTRATION


NCT02788487.",2020,"Common adverse effects were drooling, tongue numbness, and pain for TRD; and nasal blockage, mask compression, and difficult portability for CPAP.
","['obstructive sleep apnea (OSA', 'Thirty-six patients with a mean age of 52.7\u2009±\u200910.6\xa0years were enrolled', 'obstructive sleep apnea', 'Inclusion criteria were age ≥', 'Nine patients withdrew, so 27 patients were included in the final analysis', 'Exclusion criteria were severe periodontal disease, unstable cardiopulmonary or neurological diseases, and/or total sleep time <\u20092\xa0h']","['tongue-retaining device (TRD) versus continuous positive airway pressure (CPAP', 'tongue-retaining device and positive airway pressure', 'TRD/CPAP and CPAP/TRD']","['drooling, tongue numbness, and pain for TRD; and nasal blockage, mask compression, and difficult portability for CPAP', 'minimum oxygen saturation ', 'ESS and FOSQ scores', 'QOL and daytime sleepiness', 'SO 2 , Functional Outcomes of Sleep Questionnaire (FOSQ), and Epworth Sleepiness Scale (ESS) scores, treatment side effects, and adherence', 'Mean AHI', 'apnea-hypopnea index (AHI']","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0031090', 'cui_str': 'Parodontosis'}, {'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}]","[{'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}]","[{'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0020580', 'cui_str': 'Reduced Sensation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027429', 'cui_str': 'Nasal Airway Obstruction'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4706348', 'cui_str': 'Epworth Sleepiness Scale score (observable entity)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}]",36.0,0.0434626,"Common adverse effects were drooling, tongue numbness, and pain for TRD; and nasal blockage, mask compression, and difficult portability for CPAP.
","[{'ForeName': 'Wish', 'Initials': 'W', 'LastName': 'Banhiran', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road, Bangkoknoi, Bangkok, 10700, Thailand.'}, {'ForeName': 'Anuch', 'Initials': 'A', 'LastName': 'Durongphan', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road, Bangkoknoi, Bangkok, 10700, Thailand.'}, {'ForeName': 'Phawin', 'Initials': 'P', 'LastName': 'Keskool', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road, Bangkoknoi, Bangkok, 10700, Thailand. phawin.kes@mahidol.ac.th.'}, {'ForeName': 'Cheerasook', 'Initials': 'C', 'LastName': 'Chongkolwatana', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road, Bangkoknoi, Bangkok, 10700, Thailand.'}, {'ForeName': 'Choakchai', 'Initials': 'C', 'LastName': 'Metheetrairut', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road, Bangkoknoi, Bangkok, 10700, Thailand.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-019-01942-z']
607,31153604,Impact of chronic kidney disease on in-hospital outcomes following left ventricular assist device placement: A national perspective.,"BACKGROUND


Left ventricular assist devices (LVADs) are being increasingly utilized for the treatment of stage-D heart failure. A LVAD is a battery-operated, mechanical pump that assists in pumping blood out of the left ventricle (LV) into the aorta, thereby lowering left ventricular burden. Prevalence of chronic kidney disease (CKD) is increasing in patients receiving LVAD.
OBJECTIVES


The purpose of this study was to compare in-hospital mortality and hospitalization expenditure associated with CKD in patients receiving LVAD implantation.
METHODS


Using the National Inpatient Sample from January 2012 through September 2015, index hospitalizations for LVAD were identified. Based on kidney function, LVAD recipients were divided into three groups: Group 1 included patients with normal renal function or CKD stages I-III. Groups 2 and 3 comprised of patients with CKD stage IV/V, and end-stage renal disease on dialysis respectively.
RESULTS


A total of 20,656 patients received LVAD during the study period. Mean age was 56.1 years; 76.8% were men. In a fully adjusted model, in-hospital mortality was higher in group 2 (OR: 1.33, CI: 1.16-1.50) and highest in group 3 (OR: 8.95, CI: 6.90-11.61). Similarly, the length of hospitalization, and hospitalization cost were higher in group 2 and highest in group 3.
CONCLUSION


Despite improving outcomes in patients receiving LVAD, CKD remained a significant health problem. Worsening in-hospital outcomes paralleling the degree of kidney dysfunction were observed in patients receiving LVADs in this study.",2020,"In a fully adjusted model, in-hospital mortality was higher in group 2 (","['LVAD recipients were divided into three groups: Group 1 included patients with normal renal function or CKD stages I-III', 'patients receiving LVAD', 'patients receiving LVAD implantation', 'Groups 2 and 3 comprised of patients with CKD stage IV/V, and end-stage renal disease on dialysis respectively', 'Mean age was 56.1 years; 76.8% were men', '20,656 patients received LVAD during the study period']","['left ventricular assist device placement', 'Left ventricular assist devices (LVADs', 'CKD']","['hospital mortality and hospitalization expenditure', 'hospital mortality', 'length of hospitalization, and hospitalization cost', 'kidney dysfunction']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function (finding)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0151746', 'cui_str': 'Abnormal renal function (finding)'}]",20656.0,0.0187556,"In a fully adjusted model, in-hospital mortality was higher in group 2 (","[{'ForeName': 'Rajkumar', 'Initials': 'R', 'LastName': 'Doshi', 'Affiliation': 'Department of Internal Medicine, University of Nevada Reno School of Medicine, 1155 Mill St, W-11, Reno, NV 89502, United States. Electronic address: rdoshi@med.unr.edu.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Taha', 'Affiliation': 'Department of Internal Medicine, University of Nevada Reno School of Medicine, 1155 Mill St, W-11, Reno, NV 89502, United States.'}, {'ForeName': 'Sailaja', 'Initials': 'S', 'LastName': 'Pisipati', 'Affiliation': 'Department of Internal Medicine, University of Nevada Reno School of Medicine, 1155 Mill St, W-11, Reno, NV 89502, United States.'}, {'ForeName': 'Krunalkumar', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Department of Cardiology, North Shore University Hospital - Northwell Health, Manhasset, NY, United States.'}, {'ForeName': 'Jaafar', 'Initials': 'J', 'LastName': 'Al-Khafaji', 'Affiliation': 'Department of Internal Medicine, University of Nevada Reno School of Medicine, 1155 Mill St, W-11, Reno, NV 89502, United States.'}, {'ForeName': 'Rupak', 'Initials': 'R', 'LastName': 'Desai', 'Affiliation': 'Department of Cardiology, Atlanta VA Medical Center, Decatur, GA, United States.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Shah', 'Affiliation': 'Department of Internal Medicine, Mercy St. Vincent Medical Center, Toledo, OH, United States.'}, {'ForeName': 'Nageshwara', 'Initials': 'N', 'LastName': 'Gullapalli', 'Affiliation': 'Department of Internal Medicine, University of Nevada Reno School of Medicine, 1155 Mill St, W-11, Reno, NV 89502, United States.'}]",Heart & lung : the journal of critical care,['10.1016/j.hrtlng.2019.05.013']
608,31149703,"Gut Resistome After Oral Antibiotics in Preschool Children in Burkina Faso: A Randomized, Controlled Trial.","We evaluated the effect of systemic antibiotics (azithromycin, amoxicillin, cotrimoxazole, or placebo) on the gut resistome in children aged 6 to 59 months. Azithromycin and cotrimoxazole led to an increase in macrolide and sulfonamide resistance determinants. Resistome expansion can be induced with a single course of antibiotics.",2020,Azithromycin and cotrimoxazole led to an increase in macrolide and sulfonamide resistance determinants.,"['children aged 6-59 months', 'preschool children in Burkina Faso']","['systemic antibiotics (azithromycin, amoxicillin, cotrimoxazole, or placebo', 'oral antibiotics', 'Azithromycin and cotrimoxazole']",['macrolide and sulfonamide resistance determinants'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0006409', 'cui_str': 'Upper Volta'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0041044', 'cui_str': 'Sulfamethoxazole / Trimethoprim'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0003240', 'cui_str': 'Substance with macrolide structure and antibacterial mechanism of action (substance)'}, {'cui': 'C3541963', 'cui_str': 'Sulfonamides'}]",,0.146768,Azithromycin and cotrimoxazole led to an increase in macrolide and sulfonamide resistance determinants.,"[{'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Hinterwirth', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sié', 'Affiliation': 'Centre de Recherche en Sante de Nouna, Burkina Faso.'}, {'ForeName': 'Boubacar', 'Initials': 'B', 'LastName': 'Coulibaly', 'Affiliation': 'Centre de Recherche en Sante de Nouna, Burkina Faso.'}, {'ForeName': 'Lucienne', 'Initials': 'L', 'LastName': 'Ouermi', 'Affiliation': 'Centre de Recherche en Sante de Nouna, Burkina Faso.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Dah', 'Affiliation': 'Centre de Recherche en Sante de Nouna, Burkina Faso.'}, {'ForeName': 'Charlemagne', 'Initials': 'C', 'LastName': 'Tapsoba', 'Affiliation': 'Centre de Recherche en Sante de Nouna, Burkina Faso.'}, {'ForeName': 'Susie L', 'Initials': 'SL', 'LastName': 'Cummings', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco.'}, {'ForeName': 'Cindi', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco.'}, {'ForeName': 'Samarpita', 'Initials': 'S', 'LastName': 'Sarkar', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Heidelberg Institute of Global Health, Medical Faculty and University Hospital, University of Heidelberg, Germany.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Doan', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz455']
609,31201036,Maxillary implant overdentures retained by use of bars or locator attachments: 1-year findings from a randomized controlled trial.,"PURPOSE


Comparison of outcomes of maxillary implant overdentures retained by use of either locator attachments or bars in a 1-year randomized controlled trial.
METHODS


Fifty edentulous participants received four maxillary implants. They were allocated to two groups (n = 25) differing in type of prosthetic attachment used to retain the maxillary prosthesis: either locator attachments or bars were applied. After one year, implant and overdenture survival was assessed. Peri-implant hygiene (Plaque-index, presence of calculus), soft tissue conditions (Gingiva-index, Sulcus Bleeding-index and pocket probing depth) and patient satisfaction (oral health impact profile (OHIP-49), denture complaints questionnaire and general satisfaction score (GSS)) were compared. The peri-implant bone level was estimated using intra-oral radiographs (student T-test).
RESULTS


Implant survival was 96.7% in the locator group and 97.9% in the bar group. No overdentures had to be remade. Patient satisfaction was significantly greater in the bar group when rated by OHIP-49 sum score and by GSS. When comparing the denture complaints questionnaire and the separate OHIP-49 item scores, no significant difference was found. There was not a significant difference in hygiene and soft tissue conditions. Marginal bone loss was estimated 0.58 ± 0.71 mm for locators and 0.31 ± 0.47 mm for bars.
CONCLUSIONS


Maxillary overdentures on four implants retained by bars or locators were compared. Bone loss was within an acceptable range for both groups after 1 year. However, less bone was lost in the bar group. Even though both treatment options improved patient satisfaction, bars seem to be particularly beneficial with regard to OHIP-49 sum score.",2020,"Even though both treatment options improved patient satisfaction, bars seem to be particularly beneficial with regard to OHIP-49 sum score.",['Fifty edentulous participants received four maxillary implants'],"['locator attachments', 'prosthetic attachment used to retain the maxillary prosthesis: either locator attachments or bars were applied', 'maxillary implant overdentures']","['Patient satisfaction', 'peri-implant bone level', 'Implant survival', 'Bone loss', 'hygiene and soft tissue conditions', 'implant and overdenture survival', 'patient satisfaction', 'Peri-implant hygiene (Plaque-index, presence of calculus), soft tissue conditions (Gingiva-index, Sulcus Bleeding-index and pocket probing depth) and patient satisfaction (oral health impact profile (OHIP-49), denture complaints questionnaire and general satisfaction score (GSS', 'Marginal bone loss']","[{'cui': 'C0026644', 'cui_str': 'Mouth, Toothless'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]","[{'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C0079806', 'cui_str': 'Maxillary Prosthesis'}, {'cui': 'C0993613', 'cui_str': 'Bar (basic dose form)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0011459', 'cui_str': 'Overdenture'}]","[{'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0011459', 'cui_str': 'Overdenture'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0017562', 'cui_str': 'Gums'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0029162'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0011394', 'cui_str': 'Dentures'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}]",50.0,0.183689,"Even though both treatment options improved patient satisfaction, bars seem to be particularly beneficial with regard to OHIP-49 sum score.","[{'ForeName': 'G Carina', 'Initials': 'GC', 'LastName': 'Boven', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Oral and Maxillofacial Surgery, Groningen, The Netherlands. Electronic address: g.c.boven@umcg.nl.'}, {'ForeName': 'Henny J A', 'Initials': 'HJA', 'LastName': 'Meijer', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Oral and Maxillofacial Surgery, Groningen, The Netherlands; University of Groningen, University Medical Center Groningen, Dental School, Department of Implant Dentistry, Groningen, The Netherlands.'}, {'ForeName': 'Arjan', 'Initials': 'A', 'LastName': 'Vissink', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Oral and Maxillofacial Surgery, Groningen, The Netherlands.'}, {'ForeName': 'Gerry M', 'Initials': 'GM', 'LastName': 'Raghoebar', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Oral and Maxillofacial Surgery, Groningen, The Netherlands.'}]",Journal of prosthodontic research,['10.1016/j.jpor.2019.04.013']
610,31174710,Brief interventions for young adults who use drugs: The moderating effects of resilience and trauma.,"Among participants in an intervention clinical trial (N = 602), we examined resilience as a moderator of substance use outcomes by intervention condition and between participants with and without severe traumatic stress (STS). Eligibility included men and women ages 18-39 with recent multidrug use; drug treatment enrollees were excluded. Outcome measures were past 90-day frequencies of substance use and abstinence. Putative moderators were measured using the Resilience Research Centre's Adult Resilience Measure (RRC-ARM) and the Traumatic Stress Scale from the Global Appraisal of Individual Needs (GAIN). Analyses employed hierarchical linear models. High resilience predicted better substance use outcomes, and the ordering of intervention effects for high resilience participants was stepwise by intervention condition intensity. Participants with low resilience scores had poorer outcomes, and those outcomes were largely unaffected by intervention condition. Participants without STS experienced the interventions similarly to the overall sample. Regardless of the level of resilience, however, participants with STS did not benefit from the interventions. The findings point to the importance of screening for both resilience and traumatic stress prior to intervention to maximize the impact of brief interventions for substance users, and also to link those needing more intensive approaches to additional services and professional care.",2019,"High resilience predicted better substance use outcomes, and the ordering of intervention effects for high resilience participants was stepwise by intervention condition intensity.","['participants with and without severe traumatic stress (STS', 'young adults who use drugs', 'Eligibility included men and women ages 18-39 with recent multidrug use; drug treatment enrollees were excluded']",[],"['past 90-day frequencies of substance use and abstinence', ""Resilience Research Centre's Adult Resilience Measure (RRC-ARM) and the Traumatic Stress Scale""]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]",[],"[{'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}]",,0.08346,"High resilience predicted better substance use outcomes, and the ordering of intervention effects for high resilience participants was stepwise by intervention condition intensity.","[{'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Kurtz', 'Affiliation': 'Center for Applied Research on Substance Use and Health Disparities, Nova Southeastern University, 7255 NE 4(th) Avenue, Suite 112, Miami, FL 33138, USA. Electronic address: steven.kurtz@nova.edu.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Pagano', 'Affiliation': 'Department of Psychiatry, Division of Child Psychiatry, Case Western Reserve University, 10524 Euclid Avenue #1155A, Cleveland, OH 44106, USA. Electronic address: Maria.Pagano@case.edu.'}, {'ForeName': 'Mance E', 'Initials': 'ME', 'LastName': 'Buttram', 'Affiliation': 'Center for Applied Research on Substance Use and Health Disparities, Nova Southeastern University, 7255 NE 4(th) Avenue, Suite 112, Miami, FL 33138, USA. Electronic address: mance.buttram@nova.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ungar', 'Affiliation': 'Resilience Research Centre, Dalhousie University, Halifax, Canada. Electronic address: Michael.Ungar@Dal.Ca.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.03.009']
611,31764511,"Effect of High-dose Vitamin A Supplementation in Children With Sickle Cell Disease: A Randomized, Double-blind, Dose-finding Pilot Study.","Suboptimal vitamin A status (serum retinol <30 µg/dL) is associated with poor clinical outcomes in children with the hemoglobin-SS disease (HbSS), and supplementation with the recommended daily allowance of retinol is ineffective in improving vitamin A status. In a single-center randomized blinded dose-finding pilot study, we compared vitamin A and nutritional status in children with HbSS to healthy children and explored the impact of high-dose supplementation on the primary outcome serum vitamin A status. Exploratory outcomes included hematologic, nutritional, immunologic, and muscle function status in children with HbSS. A mixed-effects linear regression model evaluated associations between vitamin A dose, serum retinol, and exploratory outcomes. Twenty healthy children participated, and 22 subjects with HbSS were randomized to oral 3000 or 6000 IU/d retinol for 8 weeks; 21 subjects completed all evaluations. Serum retinol, growth, and nutritional status were all suboptimal in HbSS subjects at baseline, and supplementation did not change vitamin A status. Fetal hemoglobin (Δ=2.5, 95% confidence interval [CI], 0.5-4.3), mean corpuscular volume (Δ=2.7, 95% CI, 0.7-4.7), mean corpuscular hemoglobin (Δ=1.4, 95% CI, 0.5-2.3), and mean corpuscular hemoglobin concentration (Δ=0.5, 95% CI, 0.1-0.9) all improved with supplementation. Mild improvements in erythrocyte indices, growth status, and muscle function occurred independent of hydroxyurea use.",2020,"Serum retinol, growth, and nutritional status were all suboptimal in HbSS subjects at baseline, and supplementation did not change vitamin A status.","['children with the hemoglobin-SS disease (HbSS', 'Twenty healthy children participated, and 22 subjects with HbSS', 'children with HbSS', 'Children With Sickle Cell Disease', 'children with HbSS to healthy children']","['vitamin A and nutritional status', 'Suboptimal vitamin A status (serum retinol <30\u2009µg/dL', 'High-dose Vitamin A Supplementation']","['Fetal hemoglobin', 'Serum retinol, growth, and nutritional status', 'mean corpuscular hemoglobin', 'mean corpuscular volume', 'erythrocyte indices, growth status, and muscle function', 'hematologic, nutritional, immunologic, and muscle function status', 'mean corpuscular hemoglobin concentration']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0019035', 'cui_str': 'Hemoglobin SS'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}]","[{'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0087161', 'cui_str': 'All-Trans-Retinol'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C4524019', 'cui_str': 'Vitamin A supplementation'}]","[{'cui': 'C0015936', 'cui_str': 'Hemoglobin F'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0087161', 'cui_str': 'All-Trans-Retinol'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0369183', 'cui_str': 'Mean corpuscular hemoglobin determination (procedure)'}, {'cui': 'C0863148', 'cui_str': 'Erythrocyte mean corpuscular volume determination (procedure)'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",20.0,0.171449,"Serum retinol, growth, and nutritional status were all suboptimal in HbSS subjects at baseline, and supplementation did not change vitamin A status.","[{'ForeName': 'Jefferson N', 'Initials': 'JN', 'LastName': 'Brownell', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition.'}, {'ForeName': 'Joan I', 'Initials': 'JI', 'LastName': 'Schall', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition.'}, {'ForeName': 'Carolyn R', 'Initials': 'CR', 'LastName': 'Mcanlis', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Smith-Whitley', 'Affiliation': 'Department of Pediatrics, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Cynthia F', 'Initials': 'CF', 'LastName': 'Norris', 'Affiliation': 'Department of Pediatrics, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Virginia A', 'Initials': 'VA', 'LastName': 'Stallings', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition.'}]",Journal of pediatric hematology/oncology,['10.1097/MPH.0000000000001673']
612,31760207,"Single Cupping Thearpy Session Improves Pain, Sleep, and Disability in Patients with Nonspecific Chronic Low Back Pain.","The objective of this study was to evaluate if a single session of real or placebo cupping therapy in patients with chronic low back pain would be enough to temporarily reduce pain intensity and functional disability, enhancing their mechanical threshold and reducing local skin temperature. The outcome measures were Brief Pain Inventory, pressure pain threshold, Roland-Morris disability questionnaire and low back skin temperature. This is an experimental clinical trial; after examination (AV0), patients were submitted to real or placebo cupping therapy (15 minutes, bilaterally at the points BL23 (Shenshu), BL24 (Qihaishu) and BL25 (Dachangshu) and were revaluated immediately after the session (AV1) and after one week (AV2). The patients showed a significant improvement in all pain severity items and sleep in the Brief Pain Inventory (p < 0.05) and a decrease in disability in Roland-Morris disability questionnaire (p < 0.001). No significant differences were found in pressure pain threshold or skin temperature. No significant differences were found in any outcome of the placebo cupping therapy group. Thus, the cupping therapy is effective in reducing low back pain and decreasing disability after one single session but not in changing skin mechanical threshold or temperature.",2020,The patients showed a significant improvement in all pain severity items and sleep in the BPI and a decrease in disability in RMDQ.,"['Patients With Nonspecific Chronic Low Back Pain', 'patients with chronic LBP']","['placebo cupping therapy', 'Single Cupping Therapy Session']","['disability in RMDQ', 'Pain, Sleep And Disability', 'pain severity items and sleep', 'PPT or skin temperature', 'Brief Pain Inventory (BPI), pressure pain threshold (PPT), Roland Morris disability questionnaire (RMDQ) and low back skin temperature']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0394663', 'cui_str': 'Cupping (regime/therapy)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2939142', 'cui_str': 'Lower back (surface region)'}]",,0.0480546,The patients showed a significant improvement in all pain severity items and sleep in the BPI and a decrease in disability in RMDQ.,"[{'ForeName': 'Maria P', 'Initials': 'MP', 'LastName': 'Volpato', 'Affiliation': 'Institute of Motricity Sciences, Federal University of Alfenas, Alfenas, MG, Brazil.'}, {'ForeName': 'Izabela C A', 'Initials': 'ICA', 'LastName': 'Breda', 'Affiliation': 'Graduate Program of Biosciences Applied to Health (PPGB), Federal University of Alfenas, Alfenas, MG, Brazil.'}, {'ForeName': 'Ravena C', 'Initials': 'RC', 'LastName': 'de Carvalho', 'Affiliation': 'Graduate Program of Biosciences Applied to Health (PPGB), Federal University of Alfenas, Alfenas, MG, Brazil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'de Castro Moura', 'Affiliation': 'College of Nursing, Federal University of Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Laís L', 'Initials': 'LL', 'LastName': 'Ferreira', 'Affiliation': 'Graduate Program of Biosciences Applied to Health (PPGB), Federal University of Alfenas, Alfenas, MG, Brazil.'}, {'ForeName': 'Marcelo L', 'Initials': 'ML', 'LastName': 'Silva', 'Affiliation': 'Institute of Motricity Sciences, Federal University of Alfenas, Alfenas, MG, Brazil.'}, {'ForeName': 'Josie R T', 'Initials': 'JRT', 'LastName': 'Silva', 'Affiliation': 'Institute of Motricity Sciences, Federal University of Alfenas, Alfenas, MG, Brazil. Electronic address: josie.resende@unifal-mg.edu.br.'}]",Journal of acupuncture and meridian studies,['10.1016/j.jams.2019.11.004']
613,31028826,Direct or subacute coronary angiography in out-of-hospital cardiac arrest (DISCO)-An initial pilot-study of a randomized clinical trial.,"BACKGROUND


The clinical importance of immediate coronary angiography, with potentially subsequent percutaneous coronary intervention (PCI), in out-of-hospital cardiac arrest (OHCA) patients without ST-elevation on the ECG is unclear. In this study, we assessed feasibility and safety aspects of performing immediate coronary angiography in a pre-specified pilot phase of the 'DIrect or Subacute Coronary angiography in Out-of-hospital cardiac arrest' (DISCO) randomized controlled trial (ClinicalTrials.gov ID: NCT02309151).
METHODS


Resuscitated bystander witnessed OHCA patients >18 years without ST-elevation on the ECG were randomized to immediate coronary angiography versus standard of care. Event times, procedure related adverse events and safety variables within 7 days were recorded.
RESULTS


In total, 79 patients were randomized to immediate angiography (n = 39) or standard of care (n = 40). No major differences in baseline characteristics between the groups were found. There were no differences in the proportion of bleedings and renal failure. Three patients randomized to immediate angiography and six patients randomized to standard care died within 24 h. The median time from EMS arrival to coronary angiography was 135 min in the immediate angiography group. In patients randomized to immediate angiography a culprit lesion was found in 14/38 (36.8%) and PCI was performed in all these patients. In 6/40 (15%) patients randomized to standard of care, coronary angiography was performed before the stipulated 3 days.
CONCLUSION


In this out-of-hospital cardiac arrest population without ST-elevation, randomization to a strategy to perform immediate coronary angiography was feasible although the time window of 120 min from EMS arrival at the scene of the arrest to start of coronary angiography was not achieved. No significant safety issues were reported.",2019,No significant safety issues were reported.,"['79 patients', 'Resuscitated bystander witnessed OHCA patients >18 years without ST-elevation on the ECG']","['Direct or subacute coronary angiography', 'immediate coronary angiography', 'immediate angiography', 'Subacute Coronary angiography', 'immediate coronary angiography versus standard of care', 'percutaneous coronary intervention (PCI']","['median time from EMS arrival to coronary angiography', 'Event times, procedure related adverse events and safety variables', 'proportion of bleedings and renal failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587207', 'cui_str': 'Resuscitate'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation (finding)'}, {'cui': 'C1623258', 'cui_str': 'ECG'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}]",79.0,0.101575,No significant safety issues were reported.,"[{'ForeName': 'Ludvig', 'Initials': 'L', 'LastName': 'Elfwén', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institute, Sweden. Electronic address: Ludvig.elfwen@sll.se.'}, {'ForeName': 'Rickard', 'Initials': 'R', 'LastName': 'Lagedal', 'Affiliation': 'Department of Surgical Sciences/Anesthesiology and Intensive Care Medicine, Uppsala University, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Nordberg', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Uppsala Clinical Research Center and Department of Medical Sciences, Cardiology, Uppsala University, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Oldgren', 'Affiliation': 'Uppsala Clinical Research Center and Department of Medical Sciences, Cardiology, Uppsala University, Sweden.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Böhm', 'Affiliation': 'Division of Cardiology, Department of Medicine, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lundgren', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden; Prehospen - Centre for Prehospital Research, University of Borås, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rylander', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'van der Linden', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Hollenberg', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Erlinge', 'Affiliation': 'Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Cronberg', 'Affiliation': 'Lund University, Skane University Hospital, Department of Clinical Sciences, Division of Neurology, Lund, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Jensen', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institute, Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Friberg', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Skane University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Lilja', 'Affiliation': 'Lund University, Skane University Hospital, Department of Clinical Sciences, Division of Neurology, Lund, Sweden.'}, {'ForeName': 'Ing-Marie', 'Initials': 'IM', 'LastName': 'Larsson', 'Affiliation': 'Department of Surgical Sciences/Anesthesiology and Intensive Care Medicine, Uppsala University, Sweden.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Wallin', 'Affiliation': 'Department of Surgical Sciences/Anesthesiology and Intensive Care Medicine, Uppsala University, Sweden.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Rubertsson', 'Affiliation': 'Department of Surgical Sciences/Anesthesiology and Intensive Care Medicine, Uppsala University, Sweden.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Svensson', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden.'}]",Resuscitation,['10.1016/j.resuscitation.2019.04.027']
614,31196765,Patient satisfaction and preference with thermoplastic resin removable partial dentures: a randomised cross-over trial.,"PURPOSE


This randomised cross-over trial aimed to comparatively investigate patient preference and satisfaction with thermoplastic resin removable partial dentures (TR-RPDs) and conventional metal clasp-retained removable partial dentures (MC-RPDs).
METHODS


Twenty-eight partially dentate subjects were enrolled and randomised to receive MC-RPDs followed by TR-RPDs or vice versa (n=14, each group). The subjects were asked to score overall satisfaction and denture-related parameters 3 months after delivery of each denture. Additionally, they were asked to choose their preferred denture type at the end of the trial.
RESULTS


Of the 28 subjects, 24 (86%; mean age, 67.3 years) completed the trial. The overall satisfaction scores and ratings for oral appearance with TR-RPDs were significantly higher than those with MC-RPDs (P<0.05). Moreover, 75% (18/24) and 83% (20/24) of the subjects reported greater overall satisfaction and better oral appearance with TR-RPDs than with MC-RPDs (P<0.001, both). Scores for mucosal pain and food impaction were significantly better with TR-RPDs than with MC-RPDs (P<0.05). Relative to MC-RPDs, TR-RPDs provided slightly better oral comfort and speech, although the differences were not statistically significant (P>0.05). Scores for chewing ability, denture stability, and ease of denture cleaning were almost identical for both types of dentures.
CONCLUSIONS


These results suggest that TR-RPDs hold an advantage over MC-RPDs in terms of oral appearance and can offer greater satisfaction than MC-RPDs in partially dentate arches with at least an occluding pair in the posterior region.
CLINICAL TRIAL REGISTRATION


UMIN Clinical Trials Registry (UMIN000007310).",2020,Scores for mucosal pain and food impaction were significantly better with TR-RPDs than with MC-RPDs (P<0.05).,"['Twenty-eight partially dentate subjects', 'Of the 28 subjects, 24 (86%; mean age, 67.3 years) completed the trial', 'Patient satisfaction and preference with thermoplastic resin removable partial dentures']","['MC-RPDs followed by TR-RPDs or vice versa', 'thermoplastic resin removable partial dentures (TR-RPDs) and conventional metal clasp-retained removable partial dentures (MC-RPDs']","['Scores for chewing ability, denture stability, and ease of denture cleaning', 'overall satisfaction and better oral appearance with TR-RPDs', 'mucosal pain and food impaction', 'overall satisfaction scores and ratings for oral appearance with TR-RPDs']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0011463'}]","[{'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0011463'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0699816', 'cui_str': 'Does chew (finding)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0011454', 'cui_str': 'Denture Stability'}, {'cui': 'C0011394', 'cui_str': 'Dentures'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0858804', 'cui_str': 'Mucosal pain'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0333124', 'cui_str': 'Impaction (morphologic abnormality)'}]",,0.0655114,Scores for mucosal pain and food impaction were significantly better with TR-RPDs than with MC-RPDs (P<0.05).,"[{'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Fueki', 'Affiliation': 'Department of Removable Partial Prosthodontics, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo, Japan. Electronic address: kunfu.rpro@tmd.ac.jp.'}, {'ForeName': 'Eiko', 'Initials': 'E', 'LastName': 'Yoshida-Kohno', 'Affiliation': 'Department of Removable Partial Prosthodontics, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Inamochi', 'Affiliation': 'Department of Removable Partial Prosthodontics, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Wakabayashi', 'Affiliation': 'Department of Removable Partial Prosthodontics, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo, Japan.'}]",Journal of prosthodontic research,['10.1016/j.jpor.2019.05.003']
615,31086947,"Efficacy, Safety, and Immunogenicity of an Escherichia coli-Produced Bivalent Human Papillomavirus Vaccine: An Interim Analysis of a Randomized Clinical Trial.","BACKGROUND


The high cost and insufficient supply of human papillomavirus (HPV) vaccines have slowed the pace of controlling cervical cancer. A phase III clinical trial was conducted to evaluate the efficacy, safety, and immunogenicity of a novel Escherichia coli-produced bivalent HPV-16/18 vaccine.
METHODS


A multicenter, randomized, double-blind trial started on November 22, 2012 in China. In total, 7372 eligible women aged 18-45 years were age-stratified and randomly assigned to receive three doses of the test or control (hepatitis E) vaccine at months 0, 1, and 6. Co-primary endpoints included high-grade genital lesions and persistent infection (over 6 months) associated with HPV-16/18. The primary analysis was performed on a per-protocol susceptible population of individuals who were negative for relevant HPV type-specific neutralizing antibodies (at day 0) and DNA (at day 0 through month 7) and who received three doses of the vaccine. This report presents data from a prespecified interim analysis used for regulatory submission.
RESULTS


In the per-protocol cohort, the efficacies against high-grade genital lesions and persistent infection were 100.0% (95% confidence interval = 55.6% to 100.0%, 0 of 3306 in the vaccine group vs 10 of 3296 in the control group) and 97.8% (95% confidence interval = 87.1% to 99.9%, 1 of 3240 vs 45 of 3246), respectively. The side effects were mild. No vaccine-related serious adverse events were noted. Robust antibody responses for both types were induced and persisted for at least 42 months.
CONCLUSIONS


The E coli-produced HPV-16/18 vaccine is well tolerated and highly efficacious against HPV-16/18-associated high-grade genital lesions and persistent infection in women.",2020,The Escherichia coli-produced HPV-16/18 vaccine is well tolerated and highly efficacious against HPV-16/18 associated high-grade genital lesions and persistent infection in women.,"['7372 eligible women aged 18-45 years were age-stratified', 'November 22, 2012, in China']","['novel Escherichia coli-produced bivalent HPV-16/18 vaccine', 'Escherichia coli-produced bivalent human papillomavirus vaccine', 'test or control (hepatitis E) vaccine', 'vaccine']","['efficacy, safety and immunogenicity', 'efficacies against high-grade genital lesions and persistent infection', 'Efficacy, safety, and immunogenicity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0085293', 'cui_str': 'Hepatitis, Water-Borne'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0744369', 'cui_str': 'Lesion of genitalia'}, {'cui': 'C1264606', 'cui_str': 'Persistent infection'}]",7372.0,0.594263,The Escherichia coli-produced HPV-16/18 vaccine is well tolerated and highly efficacious against HPV-16/18 associated high-grade genital lesions and persistent infection in women.,"[{'ForeName': 'You-Lin', 'Initials': 'YL', 'LastName': 'Qiao', 'Affiliation': 'National Cancer Center, National Center for Cancer Clinical Research, The Cancer Institute, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China.'}, {'ForeName': 'Rong-Cheng', 'Initials': 'RC', 'LastName': 'Li', 'Affiliation': 'Guangxi Center for Disease Control and Prevention, Nanning, Guangxi, China.'}, {'ForeName': 'Yue-Mei', 'Initials': 'YM', 'LastName': 'Hu', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China.'}, {'ForeName': 'Li-Hui', 'Initials': 'LH', 'LastName': 'Wei', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Chang-Gui', 'Initials': 'CG', 'LastName': 'Li', 'Affiliation': 'National Institute for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'National Cancer Center, National Center for Cancer Clinical Research, The Cancer Institute, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shou-Jie', 'Initials': 'SJ', 'LastName': 'Huang', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China.'}, {'ForeName': 'Fang-Hui', 'Initials': 'FH', 'LastName': 'Zhao', 'Affiliation': 'National Cancer Center, National Center for Cancer Clinical Research, The Cancer Institute, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ming-Qiang', 'Initials': 'MQ', 'LastName': 'Li', 'Affiliation': 'Liuzhou Center for Disease Control and Prevention, Liuzhou, Guangxi, China.'}, {'ForeName': 'Qin-Jing', 'Initials': 'QJ', 'LastName': 'Pan', 'Affiliation': 'National Cancer Center, National Center for Cancer Clinical Research, The Cancer Institute, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'National Cancer Center, National Center for Cancer Clinical Research, The Cancer Institute, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Shenzhen Maternity and Child Healthcare Hospital, Shenzhen, Guangdong, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Hong', 'Affiliation': 'The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Wen-Hua', 'Initials': 'WH', 'LastName': 'Zhang', 'Affiliation': 'National Cancer Center, National Center for Cancer Clinical Research, The Cancer Institute, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yan-Ping', 'Initials': 'YP', 'LastName': 'Li', 'Affiliation': 'Guangxi Center for Disease Control and Prevention, Nanning, Guangxi, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Chu', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yun-Fei', 'Initials': 'YF', 'LastName': 'Jiang', 'Affiliation': 'The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'National Institute for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'National Institute for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Zhi-Jie', 'Initials': 'ZJ', 'LastName': 'Lin', 'Affiliation': 'Xiamen Innovax Biotech Company, Xiamen, Fujian, China.'}, {'ForeName': 'Xue-Lian', 'Initials': 'XL', 'LastName': 'Cui', 'Affiliation': 'Liuzhou Center for Disease Control and Prevention, Liuzhou, Guangxi, China.'}, {'ForeName': 'Wen-Yu', 'Initials': 'WY', 'LastName': 'Liu', 'Affiliation': 'Funing Center for Disease Control and Prevention, Funing, Jiangsu, China.'}, {'ForeName': 'Cai-Hong', 'Initials': 'CH', 'LastName': 'Li', 'Affiliation': 'Xinmi Maternal and Child Health Hospital, Xinmi, Henan, China.'}, {'ForeName': 'Dong-Ping', 'Initials': 'DP', 'LastName': 'Guo', 'Affiliation': 'Yangcheng Maternal and Child Health Hospital, Yangcheng, Shanxi, China.'}, {'ForeName': 'Li-Dong', 'Initials': 'LD', 'LastName': 'Ke', 'Affiliation': 'Fengning Hospital of Traditional Chinese Medicine, Fengning, Hebei, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Liuzhou Center for Disease Control and Prevention, Liuzhou, Guangxi, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Funing Center for Disease Control and Prevention, Funing, Jiangsu, China.'}, {'ForeName': 'Guo-Qi', 'Initials': 'GQ', 'LastName': 'Gao', 'Affiliation': 'Xinmi Maternal and Child Health Hospital, Xinmi, Henan, China.'}, {'ForeName': 'Ba-Yi', 'Initials': 'BY', 'LastName': 'Li', 'Affiliation': 'Yangcheng Maternal and Child Health Hospital, Yangcheng, Shanxi, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'Fengning Hospital of Traditional Chinese Medicine, Fengning, Hebei, China.'}, {'ForeName': 'Feng-Xian', 'Initials': 'FX', 'LastName': 'Zheng', 'Affiliation': 'Xinmi Maternal and Child Health Hospital, Xinmi, Henan, China.'}, {'ForeName': 'Cui-Hong', 'Initials': 'CH', 'LastName': 'Dai', 'Affiliation': 'Fengning Hospital of Traditional Chinese Medicine, Fengning, Hebei, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China.'}, {'ForeName': 'Ying-Ying', 'Initials': 'YY', 'LastName': 'Su', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China.'}, {'ForeName': 'Jun-Zhi', 'Initials': 'JZ', 'LastName': 'Wang', 'Affiliation': 'National Institute for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Feng-Cai', 'Initials': 'FC', 'LastName': 'Zhu', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China.'}, {'ForeName': 'Shao-Wei', 'Initials': 'SW', 'LastName': 'Li', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China.'}, {'ForeName': 'Hui-Rong', 'Initials': 'HR', 'LastName': 'Pan', 'Affiliation': 'Xiamen Innovax Biotech Company, Xiamen, Fujian, China.'}, {'ForeName': 'Yi-Min', 'Initials': 'YM', 'LastName': 'Li', 'Affiliation': 'Xiamen Innovax Biotech Company, Xiamen, Fujian, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China.'}, {'ForeName': 'Ning-Shao', 'Initials': 'NS', 'LastName': 'Xia', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China.'}]",Journal of the National Cancer Institute,['10.1093/jnci/djz074']
616,31103642,Effect of Baseline Subretinal Fluid on Treatment Outcomes in VIVID-DME and VISTA-DME Studies.,"PURPOSE


To evaluate the effect of baseline subretinal fluid (SRF) on treatment outcomes with intravitreal aflibercept injection (IAI) versus laser treatment in patients with diabetic macular edema (DME) in the VIVID and VISTA studies.
DESIGN


Post hoc analysis of 2 randomized controlled trials.
PARTICIPANTS


Eight hundred seventy-two patients with DME.
METHODS


We randomized patients to receive IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 monthly doses (2q8), or laser.
MAIN OUTCOME MEASURES


Effect of presence or absence of baseline SRF on visual outcomes in the integrated dataset at weeks 52 and 100.
RESULTS


Mean best-corrected visual acuity (BCVA) gains in the 2q4, 2q8, and laser arms at week 52 were +14.5, +11.0, and -2.3 letters, respectively, (those with baseline SRF) and +10.3, +10.6, and +2.5 letters, respectively, (those without). At week 100, mean gains were +13.5, +10.9, and -2.3 letters (those with baseline SRF) and +10.6, +10.0, and +2.7 letters (those without). The treatment effect for IAI versus laser from baseline to week 52 of 100 was greater for patients with baseline SRF versus those without (nominal P < 0.001, for interaction). The proportions of patients who gained 15 letters or more in the 2q4, 2q8, and laser arms at week 52 were 52.3%, 40.2%, and 8.9%, respectively, (those with baseline SRF) and 30.9%, 29.1%, and 8.2%, respectively, (those without) and at week 100 were 50.0%, 35.4%, and 12.9%, respectively, (those with baseline SRF) and 33.3%, 30.5%, and 12.5%, respectively, (those without). Time to first sustained SRF clearance seemed to be shorter in the IAI arms versus laser. The overall safety profile was similar in the IAI arms.
CONCLUSIONS


This post hoc analysis demonstrated the visual outcome benefits of IAI over laser, regardless of baseline SRF status. A greater treatment effect of IAI was observed in patients with baseline SRF versus those without; however, no meaningful impact of baseline SRF status on treatment outcomes with IAI was demonstrated, indicating that the differential effects of laser might have been the driving force behind the different treatment outcomes in both groups.",2019,"The proportions of patients who gained 15 letters or more in the 2q4, 2q8, and laser arms at week 52 were 52.3%, 40.2%, and 8.9%, respectively, (those with baseline SRF) and 30.9%, 29.1%, and 8.2%, respectively, (those without) and at week 100 were 50.0%, 35.4%, and 12.9%, respectively, (those with baseline SRF) and 33.3%, 30.5%, and 12.5%, respectively, (those without).","['patients with diabetic macular edema (DME) in the VIVID and VISTA studies', 'Eight hundred seventy-two patients with DME']","['baseline subretinal fluid (SRF', 'Baseline Subretinal Fluid', 'intravitreal aflibercept injection (IAI) versus laser treatment']","['Mean best-corrected visual acuity', 'overall safety profile', 'BCVA) gains', 'presence or absence of baseline SRF on visual outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C1268943', 'cui_str': 'Vivid'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0641456', 'cui_str': 'DMES'}]","[{'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C0037668', 'cui_str': 'Somatotropin-Releasing Factor 44'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0037668', 'cui_str': 'Somatotropin-Releasing Factor 44'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}]",872.0,0.12997,"The proportions of patients who gained 15 letters or more in the 2q4, 2q8, and laser arms at week 52 were 52.3%, 40.2%, and 8.9%, respectively, (those with baseline SRF) and 30.9%, 29.1%, and 8.2%, respectively, (those without) and at week 100 were 50.0%, 35.4%, and 12.9%, respectively, (those with baseline SRF) and 33.3%, 30.5%, and 12.5%, respectively, (those without).","[{'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Korobelnik', 'Affiliation': ""Service d'Ophtalmologie, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France; Team LEHA, Bordeaux Population Health Research Center, Inserm, University of Bordeaux, Bordeaux, France. Electronic address: jean-francois.korobelnik@chu-bordeaux.fr.""}, {'ForeName': 'Chengxing', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Bayer US LLC, Whippany, New Jersey.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Katz', 'Affiliation': 'Bayer US LLC, Whippany, New Jersey.'}, {'ForeName': 'Dilsher S', 'Initials': 'DS', 'LastName': 'Dhoot', 'Affiliation': 'California Retina Consultants and Research Foundation, Santa Barbara, California.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Loewenstein', 'Affiliation': 'Department of Ophthalmology, Tel Aviv Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Arnold', 'Affiliation': 'Marsden Eye Specialists, Parramatta, Australia.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Staurenghi', 'Affiliation': 'Eye Clinic, Department of Biomedical and Clinical Science, Luigi Sacco Hospital, University of Milan, Milan, Italy.'}]",Ophthalmology. Retina,['10.1016/j.oret.2019.03.015']
617,31093925,Seasonal fluctuations in weight and self-weighing behavior among adults in a behavioral weight loss intervention.,"PURPOSE


The current study aimed to observe potential seasonal fluctuations in weight and self-weighing behavior among a diverse sample of adults engaged in a behavioral weight loss intervention.
METHODS


Active duty personnel (N = 248) were randomized to either a counselor-initiated or self-paced 12-month behavioral weight loss intervention promoting daily self-weighing. Body weight and self-weighing frequency were collected from electronic scales (e-scales) provided at baseline.
RESULTS


Overall, participants lost weight from winter to spring (p = 0.02) and gained weight from fall to winter (p < 0.001). No demographic differences in weight changes were observed. Participants self-weighed less frequently during summer compared to spring (p < 0.0001), less in fall compared to summer (p < 0.0001), and less in winter compared to fall (p < 0.0001). In multivariate models, weight change and self-weighing frequency during the previous season, as well as days since randomization and intervention intensity were associated with seasonal weight changes.
CONCLUSIONS


This study is the first to observe seasonal fluctuations of weight and self-weighing behavior among adults actively engaged in a weight loss intervention, consistent with research in the general population. Findings highlight the importance of acknowledging seasonal influence within weight loss programs and trials.
LEVEL OF EVIDENCE


Level I, randomized controlled trial.",2020,"Participants self-weighed less frequently during summer compared to spring (p < 0.0001), less in fall compared to summer (p < 0.0001), and less in winter compared to fall (p < 0.0001).","['adults in a behavioral weight loss intervention', 'Active duty personnel (N\u2009=\u2009248', 'adults engaged in a behavioral weight loss intervention']",['counselor-initiated or self-paced 12-month behavioral weight loss intervention promoting daily self-weighing'],"['weight change and self-weighing frequency', 'weight changes', 'gained weight', 'Body weight and self-weighing frequency']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}]","[{'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",248.0,0.026921,"Participants self-weighed less frequently during summer compared to spring (p < 0.0001), less in fall compared to summer (p < 0.0001), and less in winter compared to fall (p < 0.0001).","[{'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'Fahey', 'Affiliation': 'Department of Psychology, The University of Memphis, 400 Innovation Drive, Memphis, TN, 38111, USA. mcfahey@memphis.edu.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Klesges', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, 66 N Pauline Street, Memphis, TN, 38105, USA.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Kocak', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, 66 N Pauline Street, Memphis, TN, 38105, USA.'}, {'ForeName': 'Gerald W', 'Initials': 'GW', 'LastName': 'Talcott', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, 66 N Pauline Street, Memphis, TN, 38105, USA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Krukowski', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, 66 N Pauline Street, Memphis, TN, 38105, USA.'}]",Eating and weight disorders : EWD,['10.1007/s40519-019-00707-7']
618,31740092,Atomized intranasal vs intravenous fentanyl in severe renal colic pain management: A randomized single-blinded clinical trial.,"OBJECTIVES


Renal colic is one of the most common painful disorders in patients referred to the emergency department. The main purpose of this study was to compare the efficiency of two methods of intravenous (IVF) and intranasal (INF) fentanyl administration in pain management in patients with severe renal colic.
MATERIALS & METHODS


This was a single-blind randomized clinical trial performed on patients with severe renal colic. The severity of pain was ≥8 based on the Numerical Rating Scale (NRS). The efficacy of pain management was compared within and between the IVF (intramuscular Ketorolac + intravenous fentanyl) and INF (intramuscular Ketorolac + intranasal fentanyl) groups at different times points. Oral consent was obtained from all the patients.
RESULTS


Of 220 individuals, 96 (43.60%) were women and 124 (56.40%) were men. There were no significant differences between the two groups regarding the baseline pain severity, age, sex, history of urolithiasis and body mass index (BMI). The pain severity showed a significant reducing trend in both groups (p < 0.0001). There was also a significant difference comparing the mean pain severity between groups at different times (p < 0.0001). In each group, the severity of pain showed significant reduction compared with its prior measurement (P < 0.0001).
CONCLUSION


Fentanyl is highly effective in controlling pain in patients with severe renal colic referring to the emergency department. Intranasal administration of fentanyl combination with ketorolac can be an appropriate, non-invasive, easy-to-use and fast alternative to the intravenous method to manage pain in these patients.",2020,"In each group, the severity of pain showed significant reduction compared with its prior measurement (P < 0.0001).
","['patients with severe renal colic referring to the emergency department', 'Of 220 individuals, 96 (43.60%) were women and 124 (56.40%) were men', 'severe renal colic pain management', 'patients with severe renal colic', 'patients referred to the emergency department']","['Fentanyl', 'Atomized intranasal vs intravenous fentanyl', 'fentanyl combination with ketorolac', 'IVF (intramuscular Ketorolac + intravenous fentanyl) and INF (intramuscular Ketorolac + intranasal fentanyl', 'intravenous (IVF) and intranasal (INF) fentanyl administration']","['efficacy of pain management', 'mean pain severity', 'baseline pain severity, age, sex, history of urolithiasis and body mass index (BMI', 'Numerical Rating Scale (NRS', 'severity of pain', 'pain severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0152169', 'cui_str': 'Acute Renal Colic'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0451641', 'cui_str': 'Urinary Lithiasis'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0222045'}]",220.0,0.0731758,"In each group, the severity of pain showed significant reduction compared with its prior measurement (P < 0.0001).
","[{'ForeName': 'Narjes', 'Initials': 'N', 'LastName': 'Nazemian', 'Affiliation': 'Department of Emergency Medicine, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Torabi', 'Affiliation': 'Department of Emergency Medicine, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: me_torabi@kmu.ac.ir.'}, {'ForeName': 'Moghaddameh', 'Initials': 'M', 'LastName': 'Mirzaee', 'Affiliation': 'Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.158483']
619,29170266,Posttreatment Infarct Volumes when Compared with 24-Hour and 90-Day Clinical Outcomes: Insights from the REVASCAT Randomized Controlled Trial.,"BACKGROUND AND PURPOSE


Endovascular therapy has become the standard of care for patients with disabling anterior circulation ischemic stroke due to proximal intracranial thrombi. Our aim was to determine whether the beneficial effect of endovascular treatment on functional outcome could be explained by a reduction in posttreatment infarct volume in the Endovascular Revascularization With Solitaire Device Versus Best Medical Therapy in Anterior Circulation Stroke Within 8 Hours (REVASCAT) trial.
MATERIALS AND METHODS


The REVASCAT trial was a multicenter randomized open-label trial with blinded outcome evaluation. Among 206 enrolled subjects (endovascular treatment,  n  = 103; control,  n  = 103), posttreatment infarct volume was measured in 204 subjects. Posttreatment infarct volumes were compared with treatment assignment and recanalization status. Appropriate statistical models were used to assess the relationship among baseline clinical and imaging variables, posttreatment infarct volume, the 24-hour NIHSS score, and functional status with the 90-day modified Rankin Scale score.
RESULTS


The median posttreatment infarct volume in all subjects was 23.7 mL (interquartile range = 68.9 mL) and 16.3 mL (interquartile range = 50.2 mL) in the endovascular treatment arm and 38.6 mL (interquartile range = 74.9 mL) in the control arm ( P  = .02 for endovascular treatment versus control subjects). Baseline NIHSS ( P  < .01), site of occlusion ( P  < .03), baseline NCCT ASPECTS ( P  < .01), and recanalization status ( P  = .02) were independently associated with posttreatment infarct volume. Baseline NIHSS ( P  < .01), time from symptom onset to randomization ( P  = .02), treatment type ( P  = .04), and recanalization status ( P  < .01) were independently associated with the 24-hour NIHSS scores. The 24-hour NIHSS score strongly mediated the relationship between treatment type and 90-day mRS ( P  < .01 for indirect effect when adjusted for age), while posttreatment infarct volume did not ( P  = .26).
CONCLUSIONS


Endovascular treatment saves brain and improves 90-day clinical outcomes primarily through a beneficial effect on the 24-hour stroke severity.",2018,"Baseline NIHSS ( P  < .01), site of occlusion ( P  < .03), baseline NCCT ASPECTS (","['patients with disabling anterior circulation ischemic stroke due to proximal intracranial thrombi', '206 enrolled subjects (endovascular treatment,  n  = 103; control,  n  = 103), posttreatment infarct volume was measured in 204 subjects']","['endovascular treatment', 'Endovascular Revascularization With Solitaire Device Versus Best Medical Therapy']","['recanalization status', 'median posttreatment infarct volume', '24-hour NIHSS scores', '24-hour NIHSS score', 'site of occlusion', 'Baseline NIHSS', '24-hour NIHSS score, and functional status with the 90-day modified Rankin Scale score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0326603', 'cui_str': 'Solitaire (organism)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C0034771', 'cui_str': 'Recanalization (morphologic abnormality)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2945843', 'cui_str': 'Site of (attribute)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}]",206.0,0.202319,"Baseline NIHSS ( P  < .01), site of occlusion ( P  < .03), baseline NCCT ASPECTS (","[{'ForeName': 'F S', 'Initials': 'FS', 'LastName': 'Al-Ajlan', 'Affiliation': 'From the Department of Clinical Neurosciences and Department of Radiology (F.S.A.-A., A.S.A.S., P.M., Z.A., A.M.D., M.G., B.K.M.), Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Al Sultan', 'Affiliation': 'From the Department of Clinical Neurosciences and Department of Radiology (F.S.A.-A., A.S.A.S., P.M., Z.A., A.M.D., M.G., B.K.M.), Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Minhas', 'Affiliation': 'From the Department of Clinical Neurosciences and Department of Radiology (F.S.A.-A., A.S.A.S., P.M., Z.A., A.M.D., M.G., B.K.M.), Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Assis', 'Affiliation': 'From the Department of Clinical Neurosciences and Department of Radiology (F.S.A.-A., A.S.A.S., P.M., Z.A., A.M.D., M.G., B.K.M.), Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'de Miquel', 'Affiliation': ""Stroke Unit (M.A.d.M.), Neurology Department, Hospital de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Millán', 'Affiliation': 'Stroke Unit (M.M., P.C., A.D.), Department of Neurosciences and Department of Radiology, Hospital Germans Trias, Universitat Autosome de Barcelona, Badalona (Barcelona), Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'San Román', 'Affiliation': 'Stroke Unit (L.S.R.), Neurology Department, Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tomassello', 'Affiliation': ""Stroke Unit (A.T.), Neurology Department, Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Demchuk', 'Affiliation': 'From the Department of Clinical Neurosciences and Department of Radiology (F.S.A.-A., A.S.A.S., P.M., Z.A., A.M.D., M.G., B.K.M.), Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'T G', 'Initials': 'TG', 'LastName': 'Jovin', 'Affiliation': 'Stroke Institute (T.G.J.), Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Cuadras', 'Affiliation': 'Stroke Unit (M.M., P.C., A.D.), Department of Neurosciences and Department of Radiology, Hospital Germans Trias, Universitat Autosome de Barcelona, Badalona (Barcelona), Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dávalos', 'Affiliation': 'Stroke Unit (M.M., P.C., A.D.), Department of Neurosciences and Department of Radiology, Hospital Germans Trias, Universitat Autosome de Barcelona, Badalona (Barcelona), Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Goyal', 'Affiliation': 'From the Department of Clinical Neurosciences and Department of Radiology (F.S.A.-A., A.S.A.S., P.M., Z.A., A.M.D., M.G., B.K.M.), Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'B K', 'Initials': 'BK', 'LastName': 'Menon', 'Affiliation': 'From the Department of Clinical Neurosciences and Department of Radiology (F.S.A.-A., A.S.A.S., P.M., Z.A., A.M.D., M.G., B.K.M.), Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada docbijoymenon@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AJNR. American journal of neuroradiology,['10.3174/ajnr.A5463']
620,29191873,Time for a Time Window Extension: Insights from Late Presenters in the ESCAPE Trial.,"BACKGROUND AND PURPOSE


The safety and efficacy of endovascular therapy for large-artery stroke in the extended time window is not yet well-established. We performed a subgroup analysis on subjects enrolled within an extended time window in the Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke (ESCAPE) trial.
MATERIALS AND METHODS


Fifty-nine of 315 subjects (33 in the intervention group and 26 in the control group) were randomized in the ESCAPE trial between 5.5 and 12 hours after last seen healthy (likely to have groin puncture administered 6 hours after that). Treatment effect sizes for all relevant outcomes (90-day mRS shift, mRS 0-2, mRS 0-1, and 24-hour NIHSS scores and intracerebral hemorrhage) were reported using unadjusted and adjusted analyses.
RESULTS


There was no evidence of treatment heterogeneity between subjects in the early and late windows. Treatment effect favoring intervention was seen across all clinical outcomes in the extended time window (absolute risk difference of 19.3% for mRS 0-2 at 90 days). There were more asymptomatic intracerebral hemorrhage events within the intervention arm (48.5% versus 11.5%,  P  = .004) but no difference in symptomatic intracerebral hemorrhage.
CONCLUSIONS


Patients with an extended time window could potentially benefit from endovascular treatment. Ongoing randomized controlled trials using imaging to identify late presenters with favorable brain physiology will help cement the paradigm of using time windows to select the population for acute imaging and imaging to select individual patients for therapy.",2018,Treatment effect favoring intervention was seen across all clinical outcomes in the extended time window (absolute risk difference of 19.3% for mRS 0-2 at 90 days).,"['Fifty-nine of 315 subjects (33 in the intervention group and 26 in the control group', 'subjects enrolled within an extended time window in the Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke (ESCAPE) trial']",['endovascular therapy'],"['safety and efficacy', 'relevant outcomes (90-day mRS shift, mRS 0-2, mRS 0-1, and 24-hour NIHSS scores and intracerebral hemorrhage', 'asymptomatic intracerebral hemorrhage events', 'symptomatic intracerebral hemorrhage']","[{'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0557702', 'cui_str': 'Window (physical object)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]",,0.127016,Treatment effect favoring intervention was seen across all clinical outcomes in the extended time window (absolute risk difference of 19.3% for mRS 0-2 at 90 days).,"[{'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Evans', 'Affiliation': 'From the Departments of Clinical Neurosciences and Radiology (J.W.E., B.R.G., F.S.A.-A., P.A.B., A.M.D., M.G., M.D.H., B.K.M.).'}, {'ForeName': 'B R', 'Initials': 'BR', 'LastName': 'Graham', 'Affiliation': 'From the Departments of Clinical Neurosciences and Radiology (J.W.E., B.R.G., F.S.A.-A., P.A.B., A.M.D., M.G., M.D.H., B.K.M.).'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pordeli', 'Affiliation': 'Community Health Sciences and Department of Medicine (P.P., M.D.H., B.K.M.), Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'F S', 'Initials': 'FS', 'LastName': 'Al-Ajlan', 'Affiliation': 'From the Departments of Clinical Neurosciences and Radiology (J.W.E., B.R.G., F.S.A.-A., P.A.B., A.M.D., M.G., M.D.H., B.K.M.).'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Willinsky', 'Affiliation': 'Department of Medical Imaging (R.W., W.J.M.).'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Montanera', 'Affiliation': 'Department of Medical Imaging (R.W., W.J.M.).'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Rempel', 'Affiliation': 'Departments of Radiology (J.L.R.).'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shuaib', 'Affiliation': 'Medicine (Neurology) (A.S.), University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Brennan', 'Affiliation': 'Departments of Neuroradiology (P.B.).'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Williams', 'Affiliation': 'Geriatric and Stroke Medicine (D.W.), Beaumont Hospital and the Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Roy', 'Affiliation': 'Departments of Radiology (D.R.).'}, {'ForeName': 'A Y', 'Initials': 'AY', 'LastName': 'Poppe', 'Affiliation': ""Neurosciences (A.Y.P.), Centre hospitalier de l'Université de Montréal, University of Montreal, Montreal, Quebec, Canada.""}, {'ForeName': 'T G', 'Initials': 'TG', 'LastName': 'Jovin', 'Affiliation': 'Department of Neurology (T.G.J.), University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Devlin', 'Affiliation': 'Erlanger Medical Centre (T.D.).'}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Baxter', 'Affiliation': 'Department of Radiology (B.W.B), Erlanger Hospital, University of Tennessee, Chattanooga, Tennessee.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Krings', 'Affiliation': 'Division of Radiology (T.K.).'}, {'ForeName': 'F L', 'Initials': 'FL', 'LastName': 'Silver', 'Affiliation': 'Division of Neurology (F.L.S., C.F.), Department of Medicine, University Health Network, Toronto Western Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'D F', 'Initials': 'DF', 'LastName': 'Frei', 'Affiliation': 'Colorado Neurological Institute (D.F.F., D.T.), Engelwood, Colorado.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Fanale', 'Affiliation': 'Division of Neurology (F.L.S., C.F.), Department of Medicine, University Health Network, Toronto Western Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tampieri', 'Affiliation': 'Colorado Neurological Institute (D.F.F., D.T.), Engelwood, Colorado.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Teitelbaum', 'Affiliation': 'Montreal Neurological Institute (J.T.), McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Iancu', 'Affiliation': 'Department of Radiology (D.I.), The Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Shankar', 'Affiliation': 'Department of Neuroradiology (J.S.), Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Barber', 'Affiliation': 'From the Departments of Clinical Neurosciences and Radiology (J.W.E., B.R.G., F.S.A.-A., P.A.B., A.M.D., M.G., M.D.H., B.K.M.).'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Demchuk', 'Affiliation': 'From the Departments of Clinical Neurosciences and Radiology (J.W.E., B.R.G., F.S.A.-A., P.A.B., A.M.D., M.G., M.D.H., B.K.M.).'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Goyal', 'Affiliation': 'From the Departments of Clinical Neurosciences and Radiology (J.W.E., B.R.G., F.S.A.-A., P.A.B., A.M.D., M.G., M.D.H., B.K.M.).'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Hill', 'Affiliation': 'From the Departments of Clinical Neurosciences and Radiology (J.W.E., B.R.G., F.S.A.-A., P.A.B., A.M.D., M.G., M.D.H., B.K.M.).'}, {'ForeName': 'B K', 'Initials': 'BK', 'LastName': 'Menon', 'Affiliation': 'From the Departments of Clinical Neurosciences and Radiology (J.W.E., B.R.G., F.S.A.-A., P.A.B., A.M.D., M.G., M.D.H., B.K.M.) docbijoymenon@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AJNR. American journal of neuroradiology,['10.3174/ajnr.A5462']
621,31096843,Effects of a web-based expert support self-management program (WEST) for women with breast cancer: A randomized controlled trial.,"INTRODUCTION


This study was a randomized controlled trial that examined the effects of a web-based expert support self-management program (WEST) on metabolic syndrome risk factors and self-efficacy among Korean women with breast cancer.
METHODS


Participants were 60 women with breast cancer (30 participants each in both the experimental and control groups) who also had metabolic risk factors. WEST is based on the self-efficacy theory and is a self-health management program consisting of a web-based program, DIETEX (which entails keeping a health diary, identifying a lifestyle type, inputting personal health information), and expert support. WEST was provided to the experimental group once a week for 24 weeks. Metabolic syndrome risk factors and self-efficacy of the experimental and control groups were examined pre-intervention and at 12 and 24 weeks after intervention.
RESULTS


The decreases in body fat, body fat percentage, and waist circumference were greater in the experimental group than in the control group at 24 weeks ( p  = 0.019,  p  = 0.025, and  p  = 0.038, respectively).
DISCUSSION


The present study can provide basic data for the development and application of interventions for women with breast cancer in the future. Additionally, we propose that WEST be included in the treatment process to complement the intervention of medical personnel for improving metabolic risk factors in women with breast cancer.",2020,"The decreases in body fat, body fat percentage, and waist circumference were greater in the experimental group than in the control group at 24 weeks ( p = 0.019, p = 0.025, and p = 0.038, respectively).
","['women with breast cancer', 'Participants were 60 women with breast cancer (30 participants each in both the experimental and control groups) who also had metabolic risk factors', 'women with breast cancer in the future', 'Korean women with breast cancer']",['web-based expert support self-management program (WEST'],"['metabolic syndrome risk factors and self-efficacy', 'body fat, body fat percentage, and waist circumference', 'Metabolic syndrome risk factors and self-efficacy', 'metabolic risk factors']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}]",60.0,0.0315839,"The decreases in body fat, body fat percentage, and waist circumference were greater in the experimental group than in the control group at 24 weeks ( p = 0.019, p = 0.025, and p = 0.038, respectively).
","[{'ForeName': 'Hye-Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, University of Ulsan, The Republic of Korea.'}, {'ForeName': 'Hee-Seung', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, The Catholic University of Korea, Seoul, The Republic of Korea.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19850386']
622,31093677,The Effects of Ganglioside-Monosialic Acid in Taxane-Induced Peripheral Neurotoxicity in Patients with Breast Cancer: A Randomized Trial.,"BACKGROUND


Taxane-induced peripheral neuropathy (TIPN) is a dose-limiting adverse effect. Ganglioside-monosialic acid (GM1) functions as a neuroprotective factor. We assessed the effects of GM1 on the prevention of TIPN in breast cancer patients.
METHODS


We conducted a randomized, double-blind, placebo-controlled trial including 206 patients with early-stage breast cancer planning to receive taxane-based adjuvant chemotherapy with a follow-up of more than 1 year. Subjects were randomly assigned to receive GM1 (80 mg, day -1 to day 2) or placebo. The primary endpoint was the Functional Assessment of Cancer Treatment Neurotoxicity subscale score after four cycles of chemotherapy. Secondary endpoints included neurotoxicity evaluated by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 and the Eastern Cooperative Oncology Group neuropathy scale. All statistical tests were two-sided.
RESULTS


In 183 evaluable patients, the GM1 group reported better mean Functional Assessment of Cancer Treatment Neurotoxicity subscale scores than patients in the placebo group after four cycles of chemotherapy (43.27, 95% confidence interval [CI] = 43.05 to 43.49 vs 34.34, 95% CI = 33.78 to 34.89; mean difference = 8.96, 95% CI = 8.38 to 9.54, P < .001). Grade 1 or higher peripheral neurotoxicity in Common Terminology Criteria for Adverse Events v4.0 scale was statistically significantly lower in the GM1 group (14.3% vs 100.0%, P < .001). Additionally, the GM1 group had a statistically significantly lower incidence of grade 1 or higher neurotoxicity assessed by Eastern Cooperative Oncology Group neuropathy scale sensory neuropathy (26.4% vs 97.8%, P < .001) and motor neuropathy subscales (20.9% vs 81.5%, P < .001).
CONCLUSIONS


The treatment with GM1 resulted in a reduction in the severity and incidence of TIPN after four cycles of taxane-containing chemotherapy in patients with breast cancer.",2020,"In 183 evaluable patients, GM1 group reported better mean FACT-Ntx subscale scores than patients in the placebo group after 4-cycles of chemotherapy (43.27 [95% CI = 43.05 to 43.49] vs 34.34 [95% CI = 33.78 to 34.89]; mean difference = 8.96","['breast cancer patients', 'Patients with Breast Cancer', '206 patients with early-stage breast cancer planning to receive', 'with a follow-up of more than 1 year', 'patients with breast cancer']","['Taxane', 'placebo', 'taxane-containing chemotherapy', 'Ganglioside-Monosialic Acid', 'taxane-based adjuvant chemotherapy', 'GM1']","['motor neuropathy subscales', 'Peripheral Neurotoxicity', 'Functional Assessment of Cancer Treatment Neurotoxicity (FACT-Ntx) subscale score', 'incidence of grade ≥ 1 neurotoxicity assessed by ENS sensory neuropathy', 'neurotoxicity evaluated by CTCAE Version 4.0 and the Eastern Cooperative Oncology Group neuropathy scale (ENS', 'mean FACT-Ntx subscale scores', 'severity and incidence of TIPN', '1 peripheral neurotoxicity in CTCAE v4.0 scale', 'Grade ≥']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0017082', 'cui_str': 'Sialoglycosphingolipids'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy (disorder)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",206.0,0.482266,"In 183 evaluable patients, GM1 group reported better mean FACT-Ntx subscale scores than patients in the placebo group after 4-cycles of chemotherapy (43.27 [95% CI = 43.05 to 43.49] vs 34.34 [95% CI = 33.78 to 34.89]; mean difference = 8.96","[{'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jiajia', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Shusen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Unger', 'Affiliation': 'Department of Health Services Research, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Arias-Fuenzalida', 'Affiliation': 'Department of Biosciences and Nutrition, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Yanxia', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jibin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Clinical Research, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Yongxiang', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Medical Statistics and Epidemiology, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Shi', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xinyue', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Roujun', 'Initials': 'R', 'LastName': 'Peng', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'An', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Xue', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xia', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Ruoxi', 'Initials': 'R', 'LastName': 'Hong', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yongyi', 'Initials': 'Y', 'LastName': 'Zhong', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Breast Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': ""Department of Breast Surgery, Lianjiang People's Hospital, Lianjiang, Guangdong, China.""}, {'ForeName': 'Anqin', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': ""Breast Disease Center, Guangdong Women and Children's Hospital, Guangzhou, Guangdong, China.""}, {'ForeName': 'Lehong', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Breast Surgery, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Cai', 'Affiliation': 'The Fourth Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China.'}, {'ForeName': 'Jinxin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Statistics and Epidemiology, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Zhongyu', 'Initials': 'Z', 'LastName': 'Yuan', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}]",Journal of the National Cancer Institute,['10.1093/jnci/djz086']
623,31093649,Pharmacokinetics of tenofovir monoester and association with intracellular tenofovir diphosphate following single-dose tenofovir disoproxil fumarate.,"BACKGROUND


Tenofovir monoester is a relatively lipophilic intermediate formed during the hydrolysis of tenofovir disoproxil to tenofovir. Its clinical pharmacokinetic profile and influence on the cellular pharmacology of tenofovir diphosphate have not been reported.
METHODS


Plasma, PBMC and dried blood spots (DBS) were obtained from HIV-uninfected adults participating in a randomized, cross-over bioequivalence study of single-dose tenofovir disoproxil fumarate (TDF)/emtricitabine unencapsulated or encapsulated with a Proteus® ingestible sensor. Plasma pharmacokinetics of tenofovir monoester and tenofovir were characterized using non-compartmental methods. Relationships with tenofovir diphosphate in DBS and PBMC were examined using mixed-effects models.
RESULTS


Samples were available from 24 participants (13 female; 19 white, 3 black, 2 Hispanic). Tenofovir monoester appeared rapidly with a median (range) Tmax of 0.5 h (0.25-2) followed by a rapid monophasic decline with a geometric mean (coefficient of variation) t½ of 26 min (31.0%). Tenofovir monoester Cmax was 131.6 ng/mL (69.8%) and AUC0-4 was 93.3 ng·h/mL (47.9%). The corresponding values for plasma tenofovir were 222.2 ng/mL (37.1%) and 448.1 ng·h/mL (30.0%). Tenofovir monoester AUC0-∞ (but not tenofovir AUC0-∞) was a significant predictor of tenofovir diphosphate in both PBMC (P = 0.015) and DBS (P = 0.005), increasing by 3.8% (95% CI 0.8%-6.8%) and 4.3% (95% CI 1.5%-7.2%), respectively, for every 10 ng·h/mL increase in tenofovir monoester.
CONCLUSIONS


Tenofovir monoester Cmax and AUC0-4 were 59.2% and 20.6% of corresponding plasma tenofovir concentrations. Tenofovir monoester was significantly associated with intracellular tenofovir diphosphate concentrations in PBMC and DBS, whereas tenofovir concentrations were not. Tenofovir monoester likely facilitates cell loading, thereby increasing tenofovir diphosphate exposures in vivo.",2019,"Tenofovir monoester was significantly associated with intracellular tenofovir diphosphate concentrations in PBMC and DBS, whereas tenofovir concentrations were not.","['24 participants (13 female; 19 white, 3 black, 2 Hispanic']","['tenofovir disoproxil to tenofovir', 'Tenofovir monoester', 'tenofovir', 'tenofovir AUC0-∞', 'intracellular tenofovir diphosphate', 'Tenofovir', 'tenofovir disoproxil fumarate (TDF)/emtricitabine unencapsulated or encapsulated with a Proteus® ingestible sensor', 'tenofovir disoproxil fumarate', 'tenofovir monoester and tenofovir', 'tenofovir diphosphate']","['Tenofovir monoester Cmax', 'Tmax', 'DBS', 'intracellular tenofovir diphosphate concentrations', 'Plasma pharmacokinetics']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}]","[{'cui': 'C0963398', 'cui_str': 'tenofovir disoproxil'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C3712637', 'cui_str': 'tenofovir diphosphate'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0205223', 'cui_str': 'Encapsulated (qualifier value)'}, {'cui': 'C0033697', 'cui_str': 'Proteus'}]","[{'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C3712637', 'cui_str': 'tenofovir diphosphate'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.10535,"Tenofovir monoester was significantly associated with intracellular tenofovir diphosphate concentrations in PBMC and DBS, whereas tenofovir concentrations were not.","[{'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Brooks', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus (AMC), Aurora, CO, USA.'}, {'ForeName': 'Mustafa E', 'Initials': 'ME', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus (AMC), Aurora, CO, USA.'}, {'ForeName': 'Jose R', 'Initials': 'JR', 'LastName': 'Castillo-Mancilla', 'Affiliation': 'Department of Medicine, School of Medicine, University of Colorado AMC, Aurora, CO, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'MaWhinney', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado AMC, Aurora, CO, USA.'}, {'ForeName': 'Keisha', 'Initials': 'K', 'LastName': 'Alexander', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus (AMC), Aurora, CO, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Tilden', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus (AMC), Aurora, CO, USA.'}, {'ForeName': 'Becky Jo', 'Initials': 'BJ', 'LastName': 'Kerr', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus (AMC), Aurora, CO, USA.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Ellison', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus (AMC), Aurora, CO, USA.'}, {'ForeName': 'Cricket', 'Initials': 'C', 'LastName': 'McHugh', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus (AMC), Aurora, CO, USA.'}, {'ForeName': 'Lane R', 'Initials': 'LR', 'LastName': 'Bushman', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus (AMC), Aurora, CO, USA.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Kiser', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus (AMC), Aurora, CO, USA.'}, {'ForeName': 'Sybil', 'Initials': 'S', 'LastName': 'Hosek', 'Affiliation': 'Department of Medicine, Stroger Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Huhn', 'Affiliation': 'Department of Medicine, Stroger Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Anderson', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus (AMC), Aurora, CO, USA.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz187']
624,31405875,A Randomized Trial of External Practice Support to Improve Cardiovascular Risk Factors in Primary Care.,"PURPOSE


We conducted a randomized controlled trial to compare the effectiveness of adding various forms of enhanced external support to practice facilitation on primary care practices' clinical quality measure (CQM) performance.
METHODS


Primary care practices across Washington, Oregon, and Idaho were eligible if they had fewer than 10 full-time clinicians. Practices were randomized to practice facilitation only, practice facilitation and shared learning, practice facilitation and educational outreach visits, or practice facilitation and both shared learning and educational outreach visits. All practices received up to 15 months of support. The primary outcome was the CQM for blood pressure control. Secondary outcomes were CQMs for appropriate aspirin therapy and smoking screening and cessation. Analyses followed an intention-to-treat approach.
RESULTS


Of 259 practices recruited, 209 agreed to be randomized. Only 42% of those offered educational outreach visits and 27% offered shared learning participated in these enhanced supports. CQM performance improved within each study arm for all 3 cardiovascular disease CQMs. After adjusting for differences between study arms, CQM improvements in the 3 enhanced practice support arms of the study did not differ significantly from those seen in practices that received practice facilitation alone (omnibus  P  = .40 for blood pressure CQM). Practices randomized to receive both educational outreach visits and shared learning, however, were more likely to achieve a blood pressure performance goal in 70% of patients compared with those randomized to practice facilitation alone (relative risk = 2.09; 95% CI, 1.16-3.76).
CONCLUSIONS


Although we found no significant differences in CQM performance across study arms, the ability of a practice to reach a target level of performance may be enhanced by adding both educational outreach visits and shared learning to practice facilitation.",2019,"After adjusting for differences between study arms, CQM improvements in the 3 enhanced practice support arms of the study did not differ significantly from those seen in practices that received practice facilitation alone (omnibus  P  = .40 for blood pressure CQM).","['Primary care practices across Washington, Oregon, and Idaho were eligible if they had fewer than 10 full-time clinicians', 'Of 259 practices recruited', 'Primary Care']","['practice facilitation and shared learning, practice facilitation and educational outreach visits, or practice facilitation and both shared learning and educational outreach visits']","['Cardiovascular Risk Factors', 'CQMs for appropriate aspirin therapy and smoking screening and cessation', 'CQM for blood pressure control', 'blood pressure performance goal', 'CQM performance', 'CQM improvements']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0029195', 'cui_str': 'Oregon'}, {'cui': 'C0020787', 'cui_str': 'Idaho'}, {'cui': 'C0443225', 'cui_str': 'Full (qualifier value)'}]","[{'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C4505155', 'cui_str': 'Shared Learning'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C4303556', 'cui_str': 'Aspirin therapy'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}]",209.0,0.0749156,"After adjusting for differences between study arms, CQM improvements in the 3 enhanced practice support arms of the study did not differ significantly from those seen in practices that received practice facilitation alone (omnibus  P  = .40 for blood pressure CQM).","[{'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Parchman', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, Washington Michael.X.Parchman@kp.org.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Anderson', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, Washington.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Dorr', 'Affiliation': 'Department of Medicine, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Lyle J', 'Initials': 'LJ', 'LastName': 'Fagnan', 'Affiliation': 'Oregon Rural Practice Research Network, Oregon Health & Sciences University, Port-land, Oregon.'}, {'ForeName': 'Ellen S', 'Initials': 'ES', 'LastName': ""O'Meara"", 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, Washington.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Tuzzio', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, Washington.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Penfold', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, Washington.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Cook', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, Washington.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Hummel', 'Affiliation': 'HealthInsight/Qualis Health, Seattle, Washington.'}, {'ForeName': 'Cullen', 'Initials': 'C', 'LastName': 'Conway', 'Affiliation': 'Oregon Rural Practice Research Network, Oregon Health & Sciences University, Port-land, Oregon.'}, {'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Cholan', 'Affiliation': 'Department of Medicine, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Laura-Mae', 'Initials': 'LM', 'LastName': 'Baldwin', 'Affiliation': 'Department of Family Medicine, Institute of Translational Health Sciences, University of Washington, Seattle, Washington.'}]",Annals of family medicine,['10.1370/afm.2407']
625,31081404,Comparison of endometrial receptivity of clomiphene citrate versus letrozole in women with polycystic ovary syndrome: a randomized controlled study.,"The aim of the study was to compare the effect of clomiphene citrate (CC) and letrozole on endometrial receptivity for ovulation induction in women with polycystic ovary syndrome (PCOS). A randomized controlled study included 160 patients diagnosed with PCOS, out of which 80 patients received 50 mg of CC and 80 patients received 2.5 mg of letrozole for successful ovulation induction. Endometrial thickness and pattern, the blood flow of uterine artery and subendometrial region, endometrial volume and vascularization index were measured. The ratio of multilayered endometrial pattern in letrozole group was significantly increased on the day of human chorionic gonadotropin (hCG) administration compared with CC group (77.5% vs. 55.0%). The volume, vascularization index (VI), flow index (FI), and vascularization flow index (VFI) of endometrium on the day of hCG administration and 7-9 days after ovulation in letrozole group were significantly increased. The biochemical pregnancy rate, clinical pregnancy rate, and ongoing pregnancy rate in letrozole group were significantly increased compared with CC group (36.3%, 30.0%, 22.5% vs. 21.3%, 13.8%, 10.0%, respectively). Letrozole increased pregnancy rates by improving endometrial receptivity compared with CC in patients with PCOS.",2019,"The biochemical pregnancy rate, clinical pregnancy rate, and ongoing pregnancy rate in letrozole group were significantly increased compared with CC group (36.3%, 30.0%, 22.5% vs. 21.3%, 13.8%, 10.0%, respectively).","['patients with PCOS', 'women with polycystic ovary syndrome', 'women with polycystic ovary syndrome (PCOS', '160 patients diagnosed with PCOS, out of which 80 patients received']","['human chorionic gonadotropin (hCG', 'Letrozole', 'clomiphene citrate versus letrozole', 'clomiphene citrate (CC) and letrozole', '50\u2009mg of CC', 'letrozole']","['volume, vascularization index (VI), flow index (FI), and vascularization flow index (VFI) of endometrium on the day of hCG administration and 7-9\u2009days after ovulation', 'Endometrial thickness and pattern, the blood flow of uterine artery and subendometrial region, endometrial volume and vascularization index', 'endometrial receptivity', 'biochemical pregnancy rate, clinical pregnancy rate, and ongoing pregnancy rate', 'ratio of multilayered endometrial pattern', 'pregnancy rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement (procedure)'}, {'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}]","[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0027686', 'cui_str': 'Pathologic Neovascularization'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0014180', 'cui_str': 'Endometrium'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0226378', 'cui_str': 'Uterine Artery'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0404845', 'cui_str': 'Biochemical pregnancy (finding)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",160.0,0.0973621,"The biochemical pregnancy rate, clinical pregnancy rate, and ongoing pregnancy rate in letrozole group were significantly increased compared with CC group (36.3%, 30.0%, 22.5% vs. 21.3%, 13.8%, 10.0%, respectively).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Gynecology and Obstetrics, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xinqiang', 'Initials': 'X', 'LastName': 'Wen', 'Affiliation': ""The 521 Hospital of Ordnance Industry, Xi'an, Shaanxi, China.""}, {'ForeName': 'Shulan', 'Initials': 'S', 'LastName': 'Lv', 'Affiliation': ""Department of Gynecology and Obstetrics, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""Department of Gynecology and Obstetrics, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': ""Department of Gynecology and Obstetrics, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': ""Department of Gynecology and Obstetrics, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}]",Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology,['10.1080/09513590.2019.1612358']
626,31734151,Efficacy of Precise Foot Massage Therapy on Pain and Anxiety Following Cardiac Surgery: Pilot Study.,"BACKGROUND


Pain is the most pervasive distressing symptom following cardiac surgery. Forty percent of postoperative cardiac patients report inadequate pain management. Undertreated acute pain results in increased anxiety, delayed wound healing, and increased chance of persistent chronic pain. Foot massage is a safe, visible complementary approach to manage acute pain following surgery.
AIM


The aim of this study is to evaluate the efficacy of integrating foot massage therapy for managing postcardiac pain.
METHOD


A randomized placebo controlled single blinded trial comparing foot massage to placebo was conducted at a large hospital in Saudi Arabia. Thirty-one patients who had undergone cardiac surgery (16 in experimental and 15 in placebo group) participated in the study. Ten-minute foot massage was delivered to the experimental group by a nurse researcher, twice during one day, within 30 minutes after receiving an opioid pain medication.
RESULTS


The findings of this study indicate that foot massage significantly (p < .05) decreases pain intensity and anxiety in patients who have undergone cardiac surgery compared with a placebo control group.
CONCLUSION


Providing non-pharmacologic interventions for pain is the responsibility of the nursing staff. Foot massage is within the scope of nursing practice and is a safe and effective manner of improving patient care. Foot massage in conjunction with pharmacological interventions is effective in improving pain and anxiety. Future studies should consider focusing on frequency, dose, feasibility, acceptability, and participants' satisfaction.",2020,"The findings of this study indicate that foot massage significantly (p < .05) decreases pain intensity and anxiety in patients who have undergone cardiac surgery compared with a placebo control group.
","['large hospital in Saudi Arabia', 'Thirty-one patients who had undergone cardiac surgery (16 in experimental and 15 in placebo group) participated in the study', 'patients who have undergone cardiac surgery']","['Foot massage', 'placebo', 'integrating foot massage therapy', 'Foot massage in conjunction with pharmacological interventions', 'Precise Foot Massage Therapy']","['Pain and Anxiety', 'pain and anxiety', 'pain intensity and anxiety', 'inadequate pain management', 'anxiety, delayed wound healing, and increased chance of persistent chronic pain']","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0036243', 'cui_str': 'Kingdom of Saudi Arabia'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3536731', 'cui_str': 'Massage Therapy'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]",,0.158738,"The findings of this study indicate that foot massage significantly (p < .05) decreases pain intensity and anxiety in patients who have undergone cardiac surgery compared with a placebo control group.
","[{'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Alameri', 'Affiliation': 'Department of Fundamental Nursing, College Nursing, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia. Electronic address: raalamri@iau.edu.sa.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Dean', 'Affiliation': 'School of Nursing, The State University of New York, Buffalo, New York, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Castner', 'Affiliation': 'School of Nursing, The State University of New York, Buffalo, New York, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Volpe', 'Affiliation': 'School of Nursing, The State University of New York, Buffalo, New York, USA.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Elghoneimy', 'Affiliation': 'College of Medicine, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Jungquist', 'Affiliation': 'School of Nursing, The State University of New York, Buffalo, New York, USA.'}]",Pain management nursing : official journal of the American Society of Pain Management Nurses,['10.1016/j.pmn.2019.09.005']
627,31074640,Transcatheter Mitral Valve Implantation with the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System.,"Mitral regurgitation is the most prevalent yet undertreated valvulopathy despite its adverse prognosis. With the emergence of transcatheter mitral interventions, the potential for this huge unmet disease burden to be addressed may finally be realized. Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System represents one of several novel solutions. Based on early data from the pilot study, its efficacy and clinical utility is currently being tested against the mainstay treatment of surgical mitral valve replacement in a randomized trial. While there remain significant challenges before transcatheter mitral intervention can become part of the routine treatment algorithm, the authors are optimistic that transcatheter mitral valve repair and intervention have the potential in revolutionizing the management of severe symptomatic mitral regurgitation.",2019,"With the emergence of transcatheter mitral interventions, the potential for this huge unmet disease burden to be addressed may finally be realized.",[],"['Transcatheter Mitral Valve Replacement System', 'Transcatheter Mitral Valve Implantation with the Medtronic Intrepid ™']",[],[],"[{'cui': 'C0442343', 'cui_str': 'Transcatheter approach (qualifier value)'}, {'cui': 'C0026268', 'cui_str': 'Replacement of mitral valve (procedure)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0026264', 'cui_str': 'Bicuspid Valve'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]",[],,0.0157235,"With the emergence of transcatheter mitral interventions, the potential for this huge unmet disease burden to be addressed may finally be realized.","[{'ForeName': 'Ji Qs', 'Initials': 'JQ', 'LastName': 'Koh', 'Affiliation': 'Department of Cardiology, Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Walton', 'Affiliation': 'Department of Cardiology, Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Marasco', 'Affiliation': 'Department of Cardiothoracic Surgery, Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Duffy', 'Affiliation': 'Department of Cardiology, Alfred Hospital, Melbourne, Victoria, Australia.'}]",Future cardiology,['10.2217/fca-2018-0082']
628,31738192,Calling Out MS Fatigue: Feasibility and Preliminary Effects of a Pilot Randomized Telephone-Delivered Exercise Intervention for Multiple Sclerosis Fatigue.,"BACKGROUND AND PURPOSE


Fatigue is a common and debilitating symptom of multiple sclerosis (MS). Exercise therapy is effective in reducing MS-related fatigue; however, its feasibility, acceptability, and effectiveness when delivered over the telephone remain unknown. This randomized study aimed to determine the feasibility and acceptability of a telephone-delivered exercise intervention for MS-related fatigue. In addition, pre-/postchange in fatigue and secondary outcomes were compared with an otherwise identical in-person delivered exercise intervention.
METHODS


Twenty participants with MS and clinically significant fatigue were randomized to 8 sessions of either telephone (n = 10) or in-person (n = 10) delivered exercise therapy. Primary outcome measures concerned feasibility (number of sessions attended), acceptability (Client Satisfaction Questionnaire), and fatigue (Fatigue Severity Scale and two 11-point numeric rating scales: fatigue intensity and interference). Data on a range of secondary outcome measures were also collected.
RESULTS


There was no difference in average session attendance by group (telephone group: 7.6 ± 1.3 sessions; in-person 7.8 ± 0.42). Acceptability and reductions in fatigue were observed regardless of group, and improvements in a range of secondary outcomes were comparable.
DISCUSSION AND CONCLUSIONS


A telephone-delivered exercise intervention that targets MS-related fatigue is both feasible and acceptable. Primary and secondary outcome measures signaled that telephone-delivered exercise may be an effective mode of delivery that overcomes barriers to care in persons with MS and warrants testing in larger efficacy trials.Video Abstract available for more insights from the authors (see Video, Supplemental Digital Content 1, http://links.lww.com/JNPT/A293).",2020,There was no difference in average session attendance by group (telephone group: 7.6 ± 1.3 sessions; in-person 7.8 ± 0.42).,"['Multiple Sclerosis Fatigue', 'Twenty participants with MS and clinically significant fatigue']","['Telephone-Delivered Exercise Intervention', 'exercise therapy', 'Exercise therapy', 'telephone-delivered exercise intervention', 'telephone']","['Acceptability and reductions in fatigue', 'average session attendance', 'feasibility (number of sessions attended), acceptability (Client Satisfaction Questionnaire), and fatigue (Fatigue Severity Scale and two 11-point numeric rating scales: fatigue intensity and interference', 'effective mode of delivery that overcomes barriers to care in persons with MS and warrants testing in larger efficacy trials', 'feasibility and acceptability']","[{'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",20.0,0.158173,There was no difference in average session attendance by group (telephone group: 7.6 ± 1.3 sessions; in-person 7.8 ± 0.42).,"[{'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Kratz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation (A.L.K., D.W.), University of Michigan, Ann Arbor; Neuroimaging and Neurorehabilitation Laboratory (M.A., A.M., T.T., N.E.F.), Wayne State University, Detroit, Michigan; Epidemiology Group (D.W.), The School of Medicine, Medical Sciences and Nutrition, Aberdeen, Scotland, United Kingdom; Program in Physical Therapy (N.E.F.), Wayne State University, Detroit, Michigan; and Department of Neurology (N.E.F.), Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Mareena', 'Initials': 'M', 'LastName': 'Atalla', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Whibley', 'Affiliation': ''}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Myles', 'Affiliation': ''}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Thurston', 'Affiliation': ''}, {'ForeName': 'Nora E', 'Initials': 'NE', 'LastName': 'Fritz', 'Affiliation': ''}]",Journal of neurologic physical therapy : JNPT,['10.1097/NPT.0000000000000296']
629,31068063,Remote neuropsychological assessment of elderly Japanese population using the Alzheimer's Disease Assessment Scale: A validation study.,"INTRODUCTION


Studies have demonstrated the high agreement of several remote neuropsychological tests using video teleconferencing (VTC) with face-to-face (FTF) tests. However, the reliability of the remotely administered Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog), one of the most commonly used neuropsychological tests to detect cognitive decline, has not been substantially elucidated, particularly in Japanese populations. Therefore, this study aimed to evaluate the reliability of the remotely administered ADAS-cog compared with FTF-administered ADAS-cog among elderly Japanese participants.
METHODS


Participants aged ≥60 years with and without cognitive impairment, i.e. those with mild cognitive impairment (MCI), those with dementia and healthy controls (HCs), were assessed with the ADAS-cog using VTC and FTF testing at an interval of >2 weeks and <3 months. The assessment order (VTC or FTF) was randomized by participants. Participants' scores were compared among the entire sample, as well as subgroups, using intra-class correlation coefficients (ICCs) in a mixed-effects model.
RESULTS


A total of 73 participants were included in the study (36 men; age, 76.3 ± 7.6 years). The ICC for the ADAS-cog total score was high in the entire sample (0.86), whereas ICCs were moderate to high for the subgroups (MCI: 0.63, dementia: 0.80 and HC: 0.74).
DISCUSSION


The results indicate that a VTC-administered ADAS-cog could be an alternative for an FTF-administered ADAS-cog, although further replication studies with larger sample sizes and a wider range of cognitive functionalities are warranted.",2020,"The ICC for the ADAS-cog total score was high in the entire sample (0.86), whereas ICCs were moderate to high for the subgroups (MCI: 0.63, dementia: 0.80 and HC: 0.74).
","[""elderly Japanese population using the Alzheimer's Disease Assessment Scale"", 'A total of 73 participants were included in the study (36 men; age, 76.3\u2009±\u20097.6 years', 'Participants aged ≥60 years with and without cognitive impairment, i.e. those with mild cognitive impairment (MCI), those with dementia and healthy controls (HCs), were assessed with the ADAS-cog using VTC and FTF testing at an interval of >2 weeks and <3 months', 'elderly Japanese participants']","['FTF-administered ADAS-cog', 'video teleconferencing (VTC']",['ADAS-cog total score'],"[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's disease assessment scale (assessment scale)""}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",73.0,0.059487,"The ICC for the ADAS-cog total score was high in the entire sample (0.86), whereas ICCs were moderate to high for the subgroups (MCI: 0.63, dementia: 0.80 and HC: 0.74).
","[{'ForeName': 'Kazunari', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Yamaoka', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Eguchi', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sato', 'Affiliation': 'Center for Outcomes Research and Economic Evaluation for Health, National Institute of Public Health, Saitama, Japan.'}, {'ForeName': 'Kiyoko', 'Initials': 'K', 'LastName': 'Iiboshi', 'Affiliation': 'Department of Clinical Psychology, Faculty of Human Relations, Shigakukan University, Kagoshima, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Kishimoto', 'Affiliation': 'Hoshi Hospital, Fukushima, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Mimura', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Taishiro', 'Initials': 'T', 'LastName': 'Kishimoto', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19845278']
630,31055879,Docetaxel-based chemotherapy combined with dexamethasone 1 mg daily oral administration for castration-resistant prostate cancer: Long-term outcomes.,"OBJECTIVES


To report long-term outcome survival analysis of docetaxel-based chemotherapy combined with dexamethasone in castration-resistant prostate cancer patients (Japan-Multinational Trial Organization Pca10-01 trial).
METHODS


The Japan-Multinational Trial Organization Pca10-01 phase II trial was a multicenter, prospective single-arm, phase II trial both in non-metastatic and metastatic castration-resistant prostate cancer patients that was organized by The Japan-Multinational Trial Organization. Patients received 75 mg/m 2  of docetaxel (every 21 days) and 0.5 mg of dexamethasone orally twice a day continuing throughout the treatment period. The primary end-point of this additional analysis was overall survival. Secondary end-points were progression-free survival and safety.
RESULTS


Between January 2011 and February 2014, a total of 76 chemotherapy-naïve castration-resistant prostate cancer patients were enrolled. The median overall survival time was 42.5 months. The median overall survival time of M1 patients was 40.5 months (M0: not reached). The median progression-free survival time was 13.2 months (M0: 15.7 months and M1: 12.3 months). The multivariate analysis predicting overall survival of M1 patients showed that time to castration-resistant prostate cancer (≥20 months) was an independent parameter (hazard ratio 0.39, P = 0.023). Regarding the safety analysis, 36 out of 74 patients (48.6%) suffered from any grade of adverse events after the protocol treatment, and 18 patients (24.3%) had grade ≥3 adverse events.
CONCLUSIONS


Docetaxel-based chemotherapy combined with dexamethasone can achieve excellent survival efficacy not only in M0 castration-resistant prostate cancer patients, but also in M1 castration-resistant prostate cancer patients.",2019,"Regarding the safety analysis, 36 out of 74 patients (48.6%) suffered from any grade of adverse events after the protocol treatment, and 18 patients (24.3%) had grade ≥3 adverse events.
","['castration-resistant prostate cancer patients (Japan-Multinational Trial Organization Pca10-01 trial', 'M0 castration-resistant prostate cancer patients', 'Between January 2011 and February 2014, a total of 76 chemotherapy-naïve castration-resistant prostate cancer patients were enrolled', 'non-metastatic and metastatic castration-resistant prostate cancer patients that was organized by The Japan-Multinational Trial Organization', 'castration-resistant prostate cancer', 'The Japan-Multinational Trial Organization']","['docetaxel-based chemotherapy combined with dexamethasone', 'Docetaxel-based chemotherapy combined with dexamethasone', 'dexamethasone', 'docetaxel']","['median overall survival time', 'grade of adverse events', 'grade ≥3 adverse events', 'survival efficacy', 'progression-free survival and safety', 'median progression-free survival time', 'overall survival']","[{'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C1300195', 'cui_str': 'Being organized'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",74.0,0.154792,"Regarding the safety analysis, 36 out of 74 patients (48.6%) suffered from any grade of adverse events after the protocol treatment, and 18 patients (24.3%) had grade ≥3 adverse events.
","[{'ForeName': 'Nobumichi', 'Initials': 'N', 'LastName': 'Tanaka', 'Affiliation': 'Department of Urology, Nara Medical University, Kashihara, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Nishimura', 'Affiliation': 'Department of Urology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Eijiro', 'Initials': 'E', 'LastName': 'Okajima', 'Affiliation': 'Department of Urology, Nara City Hospital, Nara, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ina', 'Affiliation': 'Department of Chemotherapy, Nagoya Memorial Hospital, Nagoya, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Ogawa', 'Affiliation': 'Department of Urology, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Nagata', 'Affiliation': 'Department of Urology, Keio University, Tokyo, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Akakura', 'Affiliation': 'Department of Urology, JCHO Tokyo Shinjuku Medical Center, Tokyo, Japan.'}, {'ForeName': 'Kiyohide', 'Initials': 'K', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Urology, Nara Medical University, Kashihara, Japan.'}, {'ForeName': 'Momokazu', 'Initials': 'M', 'LastName': 'Gotoh', 'Affiliation': 'Department of Urology, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Teramukai', 'Affiliation': 'Department of Biostatistics, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Hirao', 'Affiliation': 'Department of Urology, Nara Medical University, Kashihara, Japan.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14009']
631,31736342,Sacubitril/Valsartan Across the Spectrum of Ejection Fraction in Heart Failure.,"BACKGROUND


While disease-modifying therapies exist for heart failure (HF) with reduced left ventricular ejection fraction (LVEF), few options are available for patients in the higher range of LVEF (>40%). Sacubitril/valsartan has been compared with a renin-angiotensin-aldosterone-system inhibitor alone in 2 similarly designed clinical trials of patients with reduced and preserved LVEF, permitting examination of its effects across the full spectrum of LVEF.
METHODS


We combined data from PARADIGM-HF (LVEF eligibility≤40%; n=8399) and PARAGON-HF (LVEF eligibility≥45%; n=4796) in a prespecified pooled analysis. We divided randomized patients into LVEF categories: ≤22.5% (n=1269), >22.5% to 32.5% (n=3987), >32.5% to 42.5% (n=3143), > 42.5% to 52.5% (n=1427), > 52.5% to 62.5% (n=2166), and >62.5% (n=1202). We assessed time to first cardiovascular death and HF hospitalization, its components, and total heart failure hospitlizations, all-cause mortality, and noncardiovascular mortality. Incidence rates and treatment effects were examined across categories of LVEF.
RESULTS


Among 13 195 randomized patients, we observed lower rates of cardiovascular death and HF hospitalization, but similar rates of noncardiovascular death, among patients in the highest versus the lowest groups. Overall sacubitril/valsartan was superior to renin-angiotensin-aldosterone-system inhibition for first cardiovascular death or heart failure hospitalization (Hazard Ratio [HR] 0.84 [95% CI, 0.78-0.90]), cardiovascular death (HR 0.84 [95% CI, 0.76-0.92]), heart failure hospitalization (HR 0.84 [95% CI, 0.77-0.91]), and all-cause mortality (HR 0.88 [95% CI, 0.81-0.96]). The effect of sacubitril/valsartan was modified by LVEF (treatment-by-continuous LVEF interaction  P =0.02), and benefit appeared to be present for individuals with EF primarily below the normal range, although the treatment benefit for cardiovascular death diminished at a lower ejection fraction. We observed effect modification by LVEF on the efficacy of sacubitril/valsartan in both men and women with respect to composite total HF hospitalizations and cardiovascular death, although women derived benefit to higher ejection fractions.
CONCLUSIONS


The therapeutic effects of sacubitril/valsartan, compared with a renin-angiotensin-aldosterone-system inhibitor alone, vary by LVEF with treatment benefits, particularly for heart failure hospitalization, that appear to extend to patients with heart failure and mildly reduced ejection fraction. These therapeutic benefits appeared to extend to a higher LVEF range in women compared with men.
CLINICAL TRIAL REGISTRATION


https://www.clinicaltrials.gov. Unique identifiers: NCT01920711 (PARAGON-HF), NCT01035255 (PARADIGM-HF).",2020,"Overall sacubitril/valsartan was superior to RAS inhibition for first cardiovascular death or heart failure hospitalization (HR 0.84, 95% CI 0.78, 0.90), cardiovascular death (HR 0.84, 95% CI 0.76, 0.92), heart failure hospitalization (HR 0.84, 95% CI 0.77, 0.91), and all-cause mortality (HR 0.88, 95% CI 0.81, 0.96).","['patients with heart failure and mildly reduced ejection fraction', 'men and women with respect to composite total HF hospitalizations and cardiovascular death, although women derived benefit to higher ejection fractions', 'patients in the higher range of LVEF (>40', '13,195 randomized patients']","['Sacubitril/Valsartan', 'sacubitril/valsartan', 'Sacubitril/valsartan', 'LVEF']","['rates of non-cardiovascular death', 'cardiovascular death and HF hospitalization', 'time to first cardiovascular death and HF hospitalization, its components, and total heart failure hospitlizations, all-cause mortality and non-cardiovascular mortality', 'Incidence rates', 'heart failure hospitalization', 'RAS inhibition for first cardiovascular death or heart failure hospitalization', 'cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C3539085', 'cui_str': 'All'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]",,0.115373,"Overall sacubitril/valsartan was superior to RAS inhibition for first cardiovascular death or heart failure hospitalization (HR 0.84, 95% CI 0.78, 0.90), cardiovascular death (HR 0.84, 95% CI 0.76, 0.92), heart failure hospitalization (HR 0.84, 95% CI 0.77, 0.91), and all-cause mortality (HR 0.88, 95% CI 0.81, 0.96).","[{'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (S.D.S., M.V., B.L.C., M.A.P., A.D.).""}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (S.D.S., M.V., B.L.C., M.A.P., A.D.).""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'L Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (S.D.S., M.V., B.L.C., M.A.P., A.D.).""}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX (M.P.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zile', 'Affiliation': 'Medical University of South Carolina, Charleston (M.Z.).'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Swedberg', 'Affiliation': 'Department of Molecular and Clinical Medicine, University of Gothenburg, Sweden (K.S.).'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Rouleau', 'Affiliation': 'Institut de Cardiologie de Montréal, Université de Montréal, Canada (J.R.).'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'A Pfeffer', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (S.D.S., M.V., B.L.C., M.A.P., A.D.).""}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Desai', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (S.D.S., M.V., B.L.C., M.A.P., A.D.).""}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'H Lund', 'Affiliation': 'Department of Medicine, Karolinska Institutet, and Heart and Vascular Theme, Karolinska University Hospital, Stockholm, Sweden (L.H.L.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Kober', 'Affiliation': 'Department of Cardiology, Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark (L.K.).'}, {'ForeName': 'Inder', 'Initials': 'I', 'LastName': 'Anand', 'Affiliation': 'Department of Medicine, VA Medical Center and University of Minnesota, Minneapolis (I.A.).'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Sweitzer', 'Affiliation': 'Sarver Heart Center, University of Arizona College of Medicine, Tucson (N.S.).'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Linssen', 'Affiliation': 'Department of Cardiology, Hospital Group Twente, Almelo and Hengelo, The Netherlands (G.L.).'}, {'ForeName': 'Bela', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.).'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Luis Arango', 'Affiliation': 'Guatemalan Heart Institute (J.L.A.).'}, {'ForeName': 'Dragos', 'Initials': 'D', 'LastName': 'Vinereanu', 'Affiliation': 'University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital of Bucharest, Romania (D.V.).'}, {'ForeName': 'Chen-Huan', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'Department of Medicine, National Yang-Ming University, Taipei, Taiwan, Republic of China (C.-H.C.).'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Senni', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo, Italy (M.S.).'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Sibulo', 'Affiliation': ""St Luke's Heart Institute, St. Luke's Medical Center, Taguig, Philippines (A.S.).""}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Boytsov', 'Affiliation': 'National Research Center for Cardiology of the Ministry of Health of the Russian Federation, Moscow (S.B.).'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Shi', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ (V.S, A.R., M.L.).'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Rizkala', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ (V.S, A.R., M.L.).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lefkowitz', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ (V.S, A.R., M.L.).'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, United Kingdom (J.J.V.M.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.044586']
632,31735969,Weight Loss Intervention Impact on the Physical Fitness Test Scores of Air Force Service Members.,"INTRODUCTION


Overweight and obesity are a major public health concern in the United States, including among active duty military personnel. Approximately 51% of active duty personnel are classified as overweight and 15% are classified as obese. This may impact military readiness. The current study aimed to determine if a weight loss intervention impacted fitness test scores among Air Force personnel.
MATERIALS AND METHODS


From 2014 to 2016, 204 Air Force members with overweight/obesity were randomized into either a Self-paced or counselor-initiated arm in a weight loss program. Study procedures were approved by the Institutional Review Board of the 59th Medical Wing in San Antonio and were acknowledged by the Institutional Review Board at the University of Tennessee Health Science Center. Fitness test scores from before, during, and after the intervention were used to determine if the intervention resulted in improvements in overall fitness test ratings and scores on individual components of the test.
RESULTS


Participants who lost at least 5% of their weight had better fitness ratings during the intervention compared to individuals who did not lose 5%. However, in the overall sample, fitness ratings worsened from preintervention to during the intervention, and from during to postintervention. Participants with overweight had better aerobic scores pre- and postintervention as well as better abdominal circumference scores and better fitness test ratings preintervention, during the intervention and postintervention compared to participants with obesity.
CONCLUSIONS


Behavioral weight management interventions that achieve 5% weight loss may help improve military fitness test ratings.",2020,"Participants with overweight had better aerobic scores pre- and postintervention as well as better abdominal circumference scores and better fitness test ratings preintervention, during the intervention and postintervention compared to participants with obesity.
","['Participants with overweight', 'From 2014 to 2016, 204 Air Force members with overweight/obesity', 'Study procedures were approved by the Institutional Review Board of the 59th Medical Wing in San Antonio and were acknowledged by the Institutional Review Board at the University of Tennessee Health Science Center']","['weight loss intervention', 'Self-paced or counselor-initiated arm in a weight loss program']","['abdominal circumference scores and better fitness test ratings preintervention', 'fitness ratings', 'overall fitness test ratings and scores on individual components of the test', 'military fitness test ratings']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0205540', 'cui_str': 'Approved (qualifier value)'}, {'cui': 'C0086911', 'cui_str': 'Institutional Review Boards'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0039514', 'cui_str': 'Tennessee'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}]","[{'cui': 'C1300813', 'cui_str': 'Abdominal circumference (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}]",204.0,0.022092,"Participants with overweight had better aerobic scores pre- and postintervention as well as better abdominal circumference scores and better fitness test ratings preintervention, during the intervention and postintervention compared to participants with obesity.
","[{'ForeName': 'Kinsey', 'Initials': 'K', 'LastName': 'Pebley', 'Affiliation': 'Department of Psychology, University of Memphis, Memphis, TN.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Beauvais', 'Affiliation': 'Brooke Army Medical Center, Joint Base San Antonio-Lackland Air Force Base, San Antonio, TX.'}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Gladney', 'Affiliation': 'Department of Neurology, University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Kocak', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Robert C Klesges', 'Initials': 'RCK', 'LastName': 'Klesges', 'Affiliation': 'Department of Public Health Sciences, Center for Addiction Prevention Research, University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Hare', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Phyllis A', 'Initials': 'PA', 'LastName': 'Richey', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Hryshko-Mullen', 'Affiliation': 'Department of Mental Health, Wilford Hall Ambulatory Surgical Center, Joint Base San Antonio-Lackland AFB, San Antonio, TX.'}, {'ForeName': 'G Wayne', 'Initials': 'GW', 'LastName': 'Talcott', 'Affiliation': 'Department of Public Health Sciences, Center for Addiction Prevention Research, University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Krukowski', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}]",Military medicine,['10.1093/milmed/usz371']
633,31732771,"Effect of active versus passive void trials on time to patient discharge, urinary tract infection, and urinary retention: a randomized clinical trial.","PURPOSE


We sought to determine the effect of active versus passive voiding trials on time to hospital discharge and rates of urinary tract infection (UTI) and urinary retention (UR).
METHODS


We performed a prospective, randomized trial comparing active (AVT) versus passive (PVT) void trials of inpatients requiring urethral catheter removal. Of 329 eligible patients, 274 were randomized to AVT (bladder filled with saline before catheter removal) or PVT (spontaneous bladder filling after catheter removal). Primary outcome was time to hospital discharge. Secondary outcomes were UTI (NSQIP criteria) and UR (requiring repeat catheterization) within 2 weeks of void trial.
RESULTS


The median time to void was 18 (5-115) versus 236 (136-360) min in the AVT and PVT groups, respectively (p < 0.0001). However, no difference was seen in comparison of the median time to hospital discharge between AVT [28.4 (13.6-69.3) h] and PVT [30.0 (10.4-75.6) h] cohorts, respectively (p = 0.93). Six (4.8%) and 13 (12.9%) patients developed UTI in the AVT and PVT groups, respectively (p = 0.03). Eleven (8.8%) and 12 (11.9%) patients developed UR in the AVT and PVT groups, respectively (p = 0.36).
CONCLUSION


Our study comparing AVT versus PVT demonstrated no difference in time to discharge despite a 3.6 h reduction in time to void associated with AVT. AVT was associated with a 63% reduction in UTI, with no difference seen in UR rates across cohorts. Given the reduction in UTI and technical advantages, our data suggest that AVT should be considered as a recommended technique for void trial protocol.
TRIAL REGISTRATION


NCT02886143 (clinicaltrials.gov).",2020,"patients developed UR in the AVT and PVT groups, respectively (p = 0.36).
","['inpatients requiring urethral catheter removal', '329 eligible patients, 274 were randomized to']","['active versus passive void trials', 'active versus passive voiding trials', 'active (AVT) versus passive (PVT', 'AVT versus PVT', 'AVT (bladder filled with saline before catheter removal) or PVT (spontaneous bladder filling after catheter removal']","['time to hospital discharge', 'UR rates', 'median time to void', 'median time to hospital discharge', 'time to hospital discharge and rates of urinary tract infection (UTI) and urinary retention (UR', 'time to patient discharge, urinary tract infection, and urinary retention', 'UTI (NSQIP criteria) and UR (requiring repeat catheterization']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0179800', 'cui_str': 'Urethral Catheters'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter (procedure)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0080274', 'cui_str': 'Urinary Retention'}, {'cui': 'C0030685', 'cui_str': 'Patient Discharge'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}]",274.0,0.309752,"patients developed UR in the AVT and PVT groups, respectively (p = 0.36).
","[{'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Mills', 'Affiliation': 'Department of Urology, University of Virginia, P.O. Box 800422, Charlottesville, VA, 22908, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Rapp', 'Affiliation': 'Department of Urology, University of Virginia, P.O. Box 800422, Charlottesville, VA, 22908, USA. der4m@virginia.edu.'}, {'ForeName': 'Nathan M', 'Initials': 'NM', 'LastName': 'Shaw', 'Affiliation': 'Department of Urology, MedStar Health Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Helen Y', 'Initials': 'HY', 'LastName': 'Hougen', 'Affiliation': 'Department of Urology, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Hannah E', 'Initials': 'HE', 'LastName': 'Agard', 'Affiliation': 'Department of Urology, Cleveland Clinic Akron General, Akron, OH, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Case', 'Affiliation': 'Department of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Timothy L', 'Initials': 'TL', 'LastName': 'McMurry', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Noah S', 'Initials': 'NS', 'LastName': 'Schenkman', 'Affiliation': 'Department of Urology, University of Virginia, P.O. Box 800422, Charlottesville, VA, 22908, USA.'}, {'ForeName': 'Tracey L', 'Initials': 'TL', 'LastName': 'Krupski', 'Affiliation': 'Department of Urology, University of Virginia, P.O. Box 800422, Charlottesville, VA, 22908, USA.'}]",World journal of urology,['10.1007/s00345-019-03005-0']
634,32410694,"Long-term safety and tolerability of atabecestat (JNJ-54861911), an oral BACE1 inhibitor, in early Alzheimer's disease spectrum patients: a randomized, double-blind, placebo-controlled study and a two-period extension study.","BACKGROUND


Atabecestat, a potent brain-penetrable inhibitor of BACE1 activity that reduces CSF amyloid beta (Aβ), was developed for oral treatment for Alzheimer's disease (AD). The long-term safety and effect of atabecestat on cognitive performance in participants with predementia AD in two phase 2 studies were assessed.
METHODS


In the placebo-controlled double-blind parent ALZ2002 study, participants aged 50 to 85 years were randomized (1:1:1) to placebo or atabecestat 10 or 50 mg once daily (later reduced to 5 and 25 mg) for 6 months. Participants entered ALZ2004, a 12-month treatment extension with placebo or atabecestat 10 or 25 mg, followed by an open-label phase. Safety, changes in CSF biomarker levels, brain volume, and effects on cognitive performance were assessed.
RESULTS


Of 114 participants randomized in ALZ2002, 99 (87%) completed, 90 entered the ALZ2004 double-blind phase, and 77 progressed to the open-label phase. CSF Aβ fragments and sAPPβ were reduced dose-proportionately. Decreases in whole brain and hippocampal volumes were greater in participants with mild cognitive impairment (MCI) due to AD than in preclinical AD, but were not affected by treatment. In ALZ2004, change from baseline in RBANS trended toward worse scores for atabecestat versus placebo. Elevated liver enzyme adverse events reported in 12 participants on atabecestat resulted in dosage modification and increased frequency of safety monitoring. Treatment discontinuation normalized ALT or AST in all except one with pretreatment elevation, which remained mildly elevated. No case met ALT/AST > 3× ULN and total bilirubin > 2× ULN (Hy's law).
CONCLUSION


Atabecestat was associated with trend toward declines in cognition, and elevation of liver enzymes.
TRIAL REGISTRATION


ALZ2002: ClinicalTrials.gov, NCT02260674, registered October 9, 2014; ALZ2004: ClinicalTrials.gov, NCT02406027, registered April 1, 2015.",2020,Elevated liver enzyme adverse events reported in 12 participants on atabecestat resulted in dosage modification and increased frequency of safety monitoring.,"[""early Alzheimer's disease spectrum patients"", 'participants aged 50 to 85\u2009years', '114 participants randomized in ALZ2002, 99 (87%) completed', 'participants with predementia AD in two phase 2 studies were assessed', ""Alzheimer's disease (AD""]","['placebo or atabecestat 10 or 25\u2009mg, followed by an open-label phase', 'atabecestat', 'placebo or atabecestat', 'atabecestat (JNJ-54861911', 'placebo-controlled double-blind parent ALZ2002', 'placebo']","['cognitive performance', 'cognition, and elevation of liver enzymes', 'total bilirubin', 'Safety, changes in CSF biomarker levels, brain volume, and effects on cognitive performance', 'whole brain and hippocampal volumes', 'Elevated liver enzyme adverse events', 'frequency of safety monitoring']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0235996', 'cui_str': 'Hepatic enzyme increased'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]",114.0,0.639533,Elevated liver enzyme adverse events reported in 12 participants on atabecestat resulted in dosage modification and increased frequency of safety monitoring.,"[{'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Novak', 'Affiliation': 'Janssen Research and Development LLC, 1125 Trenton-Harbourton Rd, Titusville, NJ, 08560, USA. gnovak1@its.jnj.com.'}, {'ForeName': 'Johannes Rolf', 'Initials': 'JR', 'LastName': 'Streffer', 'Affiliation': 'Janssen Research and Development, a Division of Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Timmers', 'Affiliation': 'Janssen Research and Development, a Division of Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Henley', 'Affiliation': 'Janssen Research and Development LLC, 1125 Trenton-Harbourton Rd, Titusville, NJ, 08560, USA.'}, {'ForeName': 'H Robert', 'Initials': 'HR', 'LastName': 'Brashear', 'Affiliation': 'Janssen Research and Development LLC, 1125 Trenton-Harbourton Rd, Titusville, NJ, 08560, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Bogert', 'Affiliation': 'Janssen Research and Development LLC, Raritan, NJ, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Russu', 'Affiliation': 'Janssen Research and Development, a Division of Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Janssens', 'Affiliation': 'Janssen Research and Development, a Division of Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Ina', 'Initials': 'I', 'LastName': 'Tesseur', 'Affiliation': 'Janssen Research and Development, a Division of Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Tritsmans', 'Affiliation': 'Janssen Research and Development, a Division of Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Van Nueten', 'Affiliation': 'Janssen Research and Development, a Division of Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Engelborghs', 'Affiliation': 'Reference Center for Biological Markers of Dementia (BIODEM), Institute Born-Bunge, University of Antwerp, Antwerp, Belgium.'}]",Alzheimer's research & therapy,['10.1186/s13195-020-00614-5']
635,31047845,Masticatory function in complete denture wearers varying degree of mandibular bone resorption and occlusion concept: canine-guided occlusion versus bilateral balanced occlusion in a cross-over trial.,"PURPOSE


The present cross-over study evaluated the masticatory function and maximum occlusal force of edentulous patients with complete dentures with bilateral balanced occlusion (BBO) and canine guidance (CG), with normal (NR) and resorbed mandibular ridges (RR).
METHODS


Participants received new complete dentures and both occlusal concepts (BBO and CG) were applied for a period of 30 days each. The masticatory performance was evaluated with the sieving method; masticatory ability with a visual analog scale (VAS) and maximum occlusal force was assessed by means of a gnatodynamometer. Data were analyzed using repeated-measure ANOVA or Generalized Estimating Equations (GEEs), α = 0.05.
RESULTS


Thirty women completed the trial. The height of mandibular ridge was significant for the masticatory performance (ANOVA, p < 0.001, NR = 46.35 ± 12.18%, RR = 30.39 ± 9.94%), regardless of the occlusion guidance. A significant effect of the occlusion guidance was observed for the maximum occlusal force (ANOVA, p = 0.021, CG = 31.99 ± 12.74 N, BBO = 28.37 ± 9.83 N). The occlusion guidance was not significant for the masticatory performance (ANOVA, p = 0.156) and the height of the mandibular ridge did not influence on the occlusal force (ANOVA, p = 0.060). The interaction of the factors (guidance × ridge) was not significant for masticatory performance (ANOVA, p = 0.184) and occlusal force (ANOVA, p = 0.236). The VAS scores showed a significant effect of the ridge on chewing of lettuce, resulting in greater ease (GEEs, p = 0.016) and chewing quality (GEE, p = 0.028) of this food for participants with resorbed ridges. Participants with CG reported greater ease of chewing fresh bread and beef, and expressed higher quality of chew raw carrot. Participants with CG and normal ridges exhibited the highest overall chewing ability, in comparison to BBO (Bonferroni, p < 0.05, CG = 91.9, BBO = 72.7).
CONCLUSIONS


CG represents a viable alternative to the BBO in complete dentures with satisfactory clinical results related to the self-perception of chewing and occlusal force.",2019,"The height of mandibular ridge was significant for the masticatory performance (ANOVA, p < 0.001, NR = 46.35 ± 12.18%, RR = 30.39 ± 9.94%), regardless of the occlusion guidance.","['Participants received', 'edentulous patients with complete dentures with bilateral balanced occlusion (BBO) and canine guidance (CG), with normal (NR) and resorbed mandibular ridges (RR', 'Thirty women completed the trial', 'complete denture wearers varying degree of mandibular bone resorption and occlusion concept']","['canine-guided occlusion versus bilateral balanced occlusion', 'new complete dentures and both occlusal concepts (BBO and CG']","['visual analog scale (VAS) and maximum occlusal force', 'masticatory performance', 'height of the mandibular ridge', 'Masticatory function', 'chewing quality', 'VAS scores', 'height of mandibular ridge', 'maximum occlusal force']","[{'cui': 'C0026644', 'cui_str': 'Mouth, Toothless'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011455', 'cui_str': 'Denture, Complete'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0376302', 'cui_str': 'Canine Guidance'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0332243', 'cui_str': 'Ridging (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0011455', 'cui_str': 'Denture, Complete'}, {'cui': 'C1947917', 'cui_str': 'Occluded (qualifier value)'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0005654', 'cui_str': 'Occlusal Force'}, {'cui': 'C0332243', 'cui_str': 'Ridging (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0699816', 'cui_str': 'Does chew (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",30.0,0.0768741,"The height of mandibular ridge was significant for the masticatory performance (ANOVA, p < 0.001, NR = 46.35 ± 12.18%, RR = 30.39 ± 9.94%), regardless of the occlusion guidance.","[{'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Pero', 'Affiliation': 'Department of Dental Materials and Prosthodontics, Araraquara Dental School, São Paulo State University (UNESP), Araraquara, Brazil. Electronic address: anacarolpero@foar.unesp.br.'}, {'ForeName': 'Priscila M', 'Initials': 'PM', 'LastName': 'Scavassin', 'Affiliation': 'Department of Dental Materials and Prosthodontics, Araraquara Dental School, São Paulo State University (UNESP), Araraquara, Brazil.'}, {'ForeName': 'Vivian B', 'Initials': 'VB', 'LastName': 'Policastro', 'Affiliation': 'Department of Dental Materials and Prosthodontics, Araraquara Dental School, São Paulo State University (UNESP), Araraquara, Brazil.'}, {'ForeName': 'Norberto M', 'Initials': 'NM', 'LastName': 'de Oliveira Júnior', 'Affiliation': 'Department of Dental Materials and Prosthodontics, Araraquara Dental School, São Paulo State University (UNESP), Araraquara, Brazil.'}, {'ForeName': 'Danny Omar', 'Initials': 'DO', 'LastName': 'Mendoza Marin', 'Affiliation': 'Department of Dental Materials and Prosthodontics, Araraquara Dental School, São Paulo State University (UNESP), Araraquara, Brazil.'}, {'ForeName': 'Marcela Dantas Dias da', 'Initials': 'MDDD', 'LastName': 'Silva', 'Affiliation': 'Department of Dental Materials and Prosthodontics, Araraquara Dental School, São Paulo State University (UNESP), Araraquara, Brazil.'}, {'ForeName': 'Ana Flávia B', 'Initials': 'AFB', 'LastName': 'Cassiano', 'Affiliation': 'Department of Dental Materials and Prosthodontics, Araraquara Dental School, São Paulo State University (UNESP), Araraquara, Brazil.'}, {'ForeName': 'Thais de Sousa', 'Initials': 'TS', 'LastName': 'Santana', 'Affiliation': 'Department of Dental Materials and Prosthodontics, Araraquara Dental School, São Paulo State University (UNESP), Araraquara, Brazil.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'Compagnoni', 'Affiliation': 'Department of Dental Materials and Prosthodontics, Araraquara Dental School, São Paulo State University (UNESP), Araraquara, Brazil.'}]",Journal of prosthodontic research,['10.1016/j.jpor.2019.03.005']
636,29796932,"Low-phytate wholegrain bread instead of high-phytate wholegrain bread in a total diet context did not improve iron status of healthy Swedish females: a 12-week, randomized, parallel-design intervention study.","PURPOSE


To investigate the effects of eating wholegrain rye bread with high or low amounts of phytate on iron status in women under free-living conditions.
METHODS


In this 12-week, randomized, parallel-design intervention study, 102 females were allocated into two groups, a high-phytate-bread group or a low-phytate-bread group. These two groups were administered: 200 g of blanched wholegrain rye bread/day, or 200 g dephytinized wholegrain rye bread/day. The bread was administered in addition to their habitual daily diet. Iron status biomarkers and plasma alkylresorcinols were analyzed at baseline and post-intervention.
RESULTS


Fifty-five females completed the study. There was a significant difference in change over time in total body iron stores between the two groups (p < 0.035). In the low-phytate bread group (n = 24) there were significant within-group decreases in both ferritin (mean 12%; from 32 ± 7 to 27 ± 6 μg/L, geometric mean ± SEM, p < 0.018) and total body iron (mean 12%; from 6.9 ± 1.4 to 5.4 ± 1.1 mg/kg, p < 0.035). Plasma alkylresorcinols indicated that most subjects complied with the intervention
CONCLUSIONS


In Swedish females of reproductive age, no statistically significant difference in iron status was detected after 12 weeks of high-phytate wholegrain bread consumption. However, consumption of low-phytate wholegrain bread for 12 weeks resulted in a reduction of markers of iron status. Although single-meal studies clearly show an increase in iron bioavailability from dephytinization of cereals, medium-term consumption of reduced phytate bread under free-living conditions suggests that this strategy does not work to improve iron status in healthy women of reproductive age.",2019,In the high-phytate-bread group (n = 31) there was no change in any of the iron status biomarkers after 12 weeks of intervention (p > 0.05).,"['women under free-living conditions', '102 females', 'healthy Swedish females', 'Fifty-five females completed the study', 'healthy women of reproductive age']","['wholegrain bread', 'high-phytate-bread group or a low-phytate-bread group', 'blanched wholegrain rye bread/day, or 200', 'eating wholegrain rye bread with high or low amounts of phytate']","['iron status biomarkers', 'ferritin', 'iron bioavailability', 'total body iron', 'Iron status biomarkers and plasma alkylresorcinols', 'Plasma alkylresorcinols', 'reduction of markers of iron status']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086808', 'cui_str': 'Phytate'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0948786', 'cui_str': 'Blanching'}, {'cui': 'C0452545', 'cui_str': 'Rye bread (substance)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}]","[{'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",102.0,0.039502,In the high-phytate-bread group (n = 31) there was no change in any of the iron status biomarkers after 12 weeks of intervention (p > 0.05).,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hoppe', 'Affiliation': 'Department of Gastroenterology and Hepatology, Clinical Nutrition Unit, Sahlgrenska University Hospital, Gothenburg, Sweden. michael.hoppe@nutrition.gu.se.'}, {'ForeName': 'Alastair B', 'Initials': 'AB', 'LastName': 'Ross', 'Affiliation': 'Department of Biology and Biological Engineering, Food and Nutrition Science, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Svelander', 'Affiliation': 'Department of Biology and Biological Engineering, Food and Nutrition Science, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Ann-Sofie', 'Initials': 'AS', 'LastName': 'Sandberg', 'Affiliation': 'Department of Biology and Biological Engineering, Food and Nutrition Science, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Hulthén', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}]",European journal of nutrition,['10.1007/s00394-018-1722-1']
637,31728631,"Effects of raloxifene on cognition in postmenopausal women with schizophrenia: a 24-week double-blind, randomized, parallel, placebo-controlled trial.","We assessed the utility of raloxifene (60 mg/day) as an adjuvant treatment for cognitive symptoms in postmenopausal women with schizophrenia in a 24-week, double-blind, randomized, placebo-controlled study. Patients were recruited from the inpatient and outpatient services of Parc Sanitari Sant Joan de Déu, Hospital Universitari Institut Pere Mata, and Corporació Sanitària Parc Taulí. Seventy eight postmenopausal women with schizophrenia were randomized to either adjunctive raloxifene or placebo. Sixty-eight began the clinical trial (37 women on raloxifene adjunct) and 31 on placebo adjunct. The outcome measures were: memory, attention and executive function. Assessment was conducted at baseline and at week 24. Between groups homogeneity was tested with the Student's t test for continuous variables and/or the Mann-Whitney U test for ordinal variables and the χ 2  test or Fisher's exact test for categorical variables. The differences between the two groups in neuropsychological test scores were compared using the Student's t test. The sample was homogenous with respect to age, formal education, illness duration and previous pharmacological treatment. The addition of raloxifene to antipsychotic treatment as usual showed no differences in cognitive function. The daily use of 60 mg raloxifene as an adjuvant treatment in postmenopausal women with schizophrenia has no appreciable effect.ClinicalTrials.gov Identifier: NCT01573637.",2020,The addition of raloxifene to antipsychotic treatment as usual showed no differences in cognitive function.,"['postmenopausal women with schizophrenia', 'Sixty-eight began\xa0the clinical trial (37 women on raloxifene adjunct) and 31 on', 'Patients were recruited from the inpatient and outpatient services of Parc Sanitari Sant Joan de Déu, Hospital Universitari Institut Pere Mata, and Corporació Sanitària Parc Taulí', 'Seventy eight postmenopausal women with schizophrenia']","['placebo', 'placebo adjunct', 'adjunctive raloxifene or placebo', 'raloxifene']","['cognitive function', 'memory, attention and executive function', 'neuropsychological test scores']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0244404', 'cui_str': 'Raloxifene'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0086751', 'cui_str': 'Outpatient Services'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0244404', 'cui_str': 'Raloxifene'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychologic Tests'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",78.0,0.42312,The addition of raloxifene to antipsychotic treatment as usual showed no differences in cognitive function.,"[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Huerta-Ramos', 'Affiliation': 'Parc Sanitari Sant Joan de Déu, C/Antoni Pujadas, 42. Sant Boi de Llobregat, 08830, Barcelona, Spain. mehuerta@pssjd.org.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Labad', 'Affiliation': 'Corporació Sanitària Parc Taulí, Barcelona, Spain.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Cobo', 'Affiliation': 'Corporació Sanitària Parc Taulí, Barcelona, Spain.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Núñez', 'Affiliation': 'Parc Sanitari Sant Joan de Déu, C/Antoni Pujadas, 42. Sant Boi de Llobregat, 08830, Barcelona, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Creus', 'Affiliation': 'Institut Pere Mata, Tarragona, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'García-Parés', 'Affiliation': 'Hospital Nostra Senyora de Meritxell, Escaldes-Engordany, Andorra.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cuadras', 'Affiliation': 'Parc Sanitari Sant Joan de Déu, C/Antoni Pujadas, 42. Sant Boi de Llobregat, 08830, Barcelona, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Franco', 'Affiliation': 'Institut Pere Mata, Tarragona, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Miquel', 'Affiliation': 'Parc Sanitari Sant Joan de Déu, C/Antoni Pujadas, 42. Sant Boi de Llobregat, 08830, Barcelona, Spain.'}, {'ForeName': 'Julio-César', 'Initials': 'JC', 'LastName': 'Reyes', 'Affiliation': 'Institut Pere Mata, Tarragona, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Marcó-García', 'Affiliation': 'Parc Sanitari Sant Joan de Déu, C/Antoni Pujadas, 42. Sant Boi de Llobregat, 08830, Barcelona, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Usall', 'Affiliation': 'Parc Sanitari Sant Joan de Déu, C/Antoni Pujadas, 42. Sant Boi de Llobregat, 08830, Barcelona, Spain.'}]",European archives of psychiatry and clinical neuroscience,['10.1007/s00406-019-01079-w']
638,29878583,"Pharmacokinetics, Safety, and Tolerability of the Novel Chymase Inhibitor BAY 1142524 in Healthy Male Volunteers.","The orally available chymase inhibitor BAY 1142524 is currently being developed as a first-in-class treatment for left-ventricular dysfunction after myocardial infarction. Results from 3 randomized, single-center, phase 1 studies in healthy male volunteers examining the safety, tolerability, and pharmacokinetics of BAY 1142524 are summarized. In this first-in-human study, single oral doses of 1-200 mg were administered in fasted state as liquid service formulation or immediate release (IR) tablets. The relative bioavailability and the effect of a high-fat/high-calorie meal were investigated at the 5-mg dose. In a multiple-dose escalation study, doses of 5-50 mg twice daily and 100 mg once daily were given for 5 consecutive days. BAY 1142524 was safe and well tolerated and had no effects on heart rate or blood pressure compared with placebo. BAY 1142524 was absorbed with peak concentration 1-3 hours after administration for IR tablets; it was eliminated from plasma with a terminal half-life of 6.84-12.0 hours after administration of liquid service formulation or IR tablets. Plasma exposures appeared to be dose-linear, with a negligible food effect. There was only low accumulation of BAY 1142524 after multiple dosing. BAY 1142524 exhibited a pharmacokinetic profile allowing for once-daily dosing. The absence of blood pressure effects after administration of BAY 1142524 supports the combination of this novel anti-remodeling drug with existing standard of care in patients with left-ventricular dysfunction after acute myocardial infarction.",2019,BAY 1142524 was safe and well tolerated and had no effects on heart rate or blood pressure compared with placebo.,"['Healthy Male Volunteers', 'patients with left-ventricular dysfunction after acute myocardial infarction', 'healthy male volunteers']",['placebo'],"['safe and well tolerated', 'blood pressure effects', 'relative bioavailability', 'heart rate or blood pressure', 'Pharmacokinetics, Safety, and Tolerability', 'safety, tolerability, and pharmacokinetics']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242973', 'cui_str': 'Ventricular Dysfunction'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.07546,BAY 1142524 was safe and well tolerated and had no effects on heart rate or blood pressure compared with placebo.,"[{'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Kanefendt', 'Affiliation': 'Clinical Pharmacokinetics, BAYER AG, Wuppertal, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Thuß', 'Affiliation': 'Bioanalytics, BAYER AG, Wuppertal, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Becka', 'Affiliation': 'Research and Clinical Sciences Statistics, BAYER AG, Wuppertal, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Boxnick', 'Affiliation': 'CRS Clinical Research Services, Wuppertal GmbH, Wuppertal, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Berse', 'Affiliation': 'CRS Clinical Research Services, Berlin GmbH, Berlin, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Schultz', 'Affiliation': 'CRS Clinical Research Services, Mannheim GmbH, Mannheim, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Otto', 'Affiliation': 'Experimental Medicine Cardiovascular and Hematology, BAYER AG, Wuppertal, Germany.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.579']
639,30820995,A novel clinical nomogram to predict bilateral hyperaldosteronism in Chinese patients with primary aldosteronism.,"CONTEXT


Adrenal venous sampling (AVS) is recommended as the gold standard for subtype classification in primary aldosteronism (PA); however, this approach has limited availability.
OBJECTIVE


We aimed to develop a novel clinical nomogram to predict PA subtype based on routine variables, thereby reducing the number of candidates for AVS.
PATIENTS AND METHOD


Patients were randomly divided into a training set (n = 185) and a validation set (n = 79). Risk factors for idiopathic hyperaldosteronism (IHA) differentiating from aldosterone-producing adenoma (APA) were identified using logistic regression analysis. A nomogram was constructed to predict the probability of IHA. A receiver operating characteristic (ROC) curve and a calibration plot were applied to assess the predictive value. Then, 115 patients were prospectively enrolled, and a nomogram was used to predict the subtypes before AVS.
RESULTS


Body mass index (BMI), serum potassium and computed tomography (CT) finding were adopted in the nomogram. The nomogram presented an area under the ROC (AUC) of 0.924 (95% CI: 0.875-0.957), sensitivity of 86.59% and specificity of 87.38% in the training set and an AUC of 0.894 (95% CI: 0.804-0.952), sensitivity of 82.86% and specificity of 84.09% in the validation set. Predicted probability and actual probability matched well in the nomogram (Hosmer-Lemeshow test: P > 0.05). Using the nomogram as a surrogate to predict IHA in the prospective set before AVS, the specificity reached 100% when we increased the threshold to a probability of 90%.
CONCLUSION


We have developed a tool that is able to predict IHA in patients with PA and potentially avoid AVS.",2019,"The nomogram presented an area under the ROC (AUC) of 0.924 (95% CI: 0.875-0.957), sensitivity of 86.59% and specificity of 87.38% in the training set and an AUC of 0.894 (95% CI: 0.804-0.952), sensitivity of 82.86% and specificity of 84.09% in the validation set.","['Patients were randomly divided into a training set (n\xa0=\xa0185) and a validation set (n\xa0=\xa079', 'Chinese patients with primary aldosteronism', 'patients with PA and potentially avoid AVS', '115 patients were prospectively enrolled, and a nomogram was used to predict the subtypes before AVS']",[],"['Body mass index (BMI), serum potassium and computed tomography (CT', 'Adrenal venous sampling (AVS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C1384514', 'cui_str': 'Primary Hyperaldosteronism'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C1450294', 'cui_str': 'Nomograms'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}]",[],"[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0457942', 'cui_str': 'Adrenal vein sampling catheter procedure (procedure)'}]",115.0,0.0292427,"The nomogram presented an area under the ROC (AUC) of 0.924 (95% CI: 0.875-0.957), sensitivity of 86.59% and specificity of 87.38% in the training set and an AUC of 0.894 (95% CI: 0.804-0.952), sensitivity of 82.86% and specificity of 84.09% in the validation set.","[{'ForeName': 'Libin', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Shanghai Key Laboratory for Endocrine Tumors, Shanghai Clinical Center for Endocrine and Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of Chinese Health Ministry, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Key Laboratory for Endocrine Tumors, Shanghai Clinical Center for Endocrine and Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of Chinese Health Ministry, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Key Laboratory for Endocrine Tumors, Shanghai Clinical Center for Endocrine and Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of Chinese Health Ministry, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Key Laboratory for Endocrine Tumors, Shanghai Clinical Center for Endocrine and Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of Chinese Health Ministry, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Shanghai Key Laboratory for Endocrine Tumors, Shanghai Clinical Center for Endocrine and Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of Chinese Health Ministry, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Tingwei', 'Initials': 'T', 'LastName': 'Su', 'Affiliation': 'Shanghai Key Laboratory for Endocrine Tumors, Shanghai Clinical Center for Endocrine and Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of Chinese Health Ministry, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Ning', 'Affiliation': 'Shanghai Key Laboratory for Endocrine Tumors, Shanghai Clinical Center for Endocrine and Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of Chinese Health Ministry, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Weiqing', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Shanghai Key Laboratory for Endocrine Tumors, Shanghai Clinical Center for Endocrine and Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of Chinese Health Ministry, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}]",Clinical endocrinology,['10.1111/cen.13962']
640,31353479,Effect of Lercanidipine on the Pharmacokinetics-Pharmacodynamics of Carvedilol Enantiomers in Patients With Chronic Kidney Disease.,"This study evaluates the carvedilol-lercanidipine drug interaction, and the influence of chronic kidney disease (CKD) on both drugs. Patients with high blood pressure (8 with normal renal function [control] and 8 with CKD with estimated glomerular filtration rate categories of G3b to G5 [12-38 mL/min/1.73 m 2  ]) were included and prescribed 3 different treatment regimens, a single oral dose of racemic carvedilol 25 mg (CAR), a single oral dose of racemic lercanidipine 20 mg (LER), and single oral doses of CAR plus LER. Blood samples were collected and variations in heart rate were assessed (using isometric exercise with handgrip) for up to 32 hours. Lercanidipine pharmacokinetics were not enantioselective, and were not affected by carvedilol and CKD. Carvedilol pharmacokinetics (data presented as median) were enantioselective with higher plasma exposure of (R)-(+)-carvedilol in both control (103.5 vs 46.0 ng ∙ h/mL) and CKD (190.6 vs 98.9 ng ∙ h/mL) groups. Lercanidipine increased the area under the plasma concentration-time curve of only (R)-(+)-carvedilol in the CKD group (190.6 vs 242.2 ng ∙ h/mL) but not in the control group (103.5 vs 98.7 ng ∙ h/mL). CKD increased plasma exposure (46.0 vs 98.9 ng ∙ h/mL) and effect-compartment exposure (5.5 vs 20.9 ng ∙ h/mL) to (S)-(-)-carvedilol, resulting in higher β-adrenergic inhibition (10.0 vs 6.1 bpm). Therefore, carvedilol dose titration in CKD patients with estimated glomerular filtration rate categories of G3b to G5 should be initiated, with no more than half the dose used for patients with normal renal function.",2020,"Lercanidipine pharmacokinetics were not enantioselective, and were not affected by carvedilol and CKD.","['CKD patients', 'Patients With Chronic Kidney Disease', 'Patients with high blood pressure (8 with normal renal function [control] and 8 with CKD with estimated glomerular filtration rate categories of G3b to G5']","['racemic carvedilol 25 mg (CAR', 'carvedilol-lercanidipine', 'Lercanidipine', 'carvedilol', 'racemic lercanidipine 20 mg (LER), and single oral doses of CAR plus LER', 'Carvedilol Enantiomers']","['plasma concentration-time curve of only (R)-(+)-carvedilol', 'CKD increased plasma exposure', 'β-adrenergic inhibition', 'heart rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function (finding)'}, {'cui': 'C3811844'}]","[{'cui': 'C0984555', 'cui_str': 'carvedilol 25 MG'}, {'cui': 'C0004381', 'cui_str': 'Automobiles'}, {'cui': 'C0054836', 'cui_str': 'carvedilol'}, {'cui': 'C0526399', 'cui_str': 'lercanidipine'}, {'cui': 'C1166419', 'cui_str': 'lercanidipine 20 MG'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C4704735', 'cui_str': 'Carvedilol, (+)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0001637', 'cui_str': 'Adrenergic Drugs'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",38.0,0.0311154,"Lercanidipine pharmacokinetics were not enantioselective, and were not affected by carvedilol and CKD.","[{'ForeName': 'Estela', 'Initials': 'E', 'LastName': 'Hanauer Schaab', 'Affiliation': 'Faculdade de Ciências Farmacêuticas de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Vera Lucia', 'Initials': 'VL', 'LastName': 'Lanchote', 'Affiliation': 'Faculdade de Ciências Farmacêuticas de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Glauco Henrique', 'Initials': 'GH', 'LastName': 'Balthazar Nardotto', 'Affiliation': 'Faculdade de Ciências Farmacêuticas de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Maria Paula', 'Initials': 'MP', 'LastName': 'Marques Pereira', 'Affiliation': 'Faculdade de Ciências Farmacêuticas de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Márcio', 'Initials': 'M', 'LastName': 'Dantas', 'Affiliation': 'Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Carlos Eduardo', 'Initials': 'CE', 'LastName': 'Paiva', 'Affiliation': 'Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Barbosa Coelho', 'Affiliation': 'Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, Brazil.'}]",Journal of clinical pharmacology,['10.1002/jcph.1485']
641,31727672,Study protocol: a randomised non-inferiority trial using interactive virtual presence to remotely assist parents with child restraint installations.,"BACKGROUND


Motor vehicle crashes are the third-leading cause of death to American children aged 1-5 years. When installed correctly, child restraints (car seats) reduce risk of serious injury and death. However, most restraints are installed incorrectly. The current gold standard for correct installation is systematic car seat checks, where certified technicians help parents, but car seat checks are highly underused due to barriers in access, scheduling and resources.
METHODS


The present study protocol describes plans to evaluate use of interactive virtual presence technology (interactive merged reality)-joint, simultaneous remote verbal and visual interaction and exposure to the same 3D stimuli-to assist remotely located parents installing child restraints. If effective, this technology could supplement or replace in-person checks and revolutionise how government, industry and non-profits help parents install child restraints properly. Building from preliminary studies, we propose a randomised non-inferiority trial to evaluate whether parents who install child restraints while communicating with remote expert technicians via interactive virtual presence on their smartphones achieve installations and learning not inferior in safety to parents who install restraints with on-site technicians. We will randomly assign 1476 caregivers at 7 US sites to install child restraints either via interactive virtual presence or live technicians. Correctness of installation will be assessed using objective checklists, both following installation and again 4 months later.
CONCLUSION


We aim to demonstrate that child restraint installation is accurate (>90% correct) when conducted remotely, that such installations are not inferior to installation accuracy with live experts and that parents learn and retain information about child restraint installation.",2020,"Building from preliminary studies, we propose a randomised non-inferiority trial to evaluate whether parents who install child restraints while communicating with remote expert technicians via interactive virtual presence on their smartphones achieve installations and learning not inferior in safety to parents who install restraints with on-site technicians.","['American children aged 1-5 years', 'parents with child restraint installations', '1476 caregivers at 7 US sites to install child restraints either via interactive virtual presence or live technicians', 'parents who install child restraints while communicating with remote expert technicians via interactive virtual presence on their smartphones achieve installations and learning not inferior in safety to parents who install restraints with on-site technicians']","['interactive virtual presence technology (interactive merged reality)-joint, simultaneous remote verbal and visual interaction and exposure to the same 3D stimuli-to assist remotely located parents installing child restraints']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0566001', 'cui_str': 'Does communicate (finding)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",[],1476.0,0.13722,"Building from preliminary studies, we propose a randomised non-inferiority trial to evaluate whether parents who install child restraints while communicating with remote expert technicians via interactive virtual presence on their smartphones achieve installations and learning not inferior in safety to parents who install restraints with on-site technicians.","[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Schwebel', 'Affiliation': 'Psychology, University of Alabama at Birmingham, Birmingham, Alabama, USA schwebel@uab.edu.'}, {'ForeName': 'Jennifer Morag', 'Initials': 'JM', 'LastName': 'MacKay', 'Affiliation': 'Safe Kids Worldwide, Washington, District of Columbia, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Redden', 'Affiliation': 'Biostatistics, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}]",Injury prevention : journal of the International Society for Child and Adolescent Injury Prevention,['10.1136/injuryprev-2019-043463']
642,31012984,"Safety, Pharmacokinetics, and Pharmacodynamics of the Autotaxin Inhibitor GLPG1690 in Healthy Subjects: Phase 1 Randomized Trials.","GLPG1690 is a novel autotaxin inhibitor in development for the treatment of idiopathic pulmonary fibrosis (IPF). We report phase 1 studies investigating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GLPG1690 in healthy subjects. We performed a first-in-human randomized, double-blind, placebo-controlled trial of single (20, 60, 150, 300, 600, 1000, 1500 mg) and multiple (14 days: 150 mg twice daily; 600 and 1000 mg once daily) ascending oral doses of GLPG1690 (NCT02179502), and a randomized, open-label, crossover relative bioavailability study to compare the PK of tablet and capsule formulations of GLPG1690 600 mg and to assess the effect of food on PK of the tablet formulation (NCT03143712). Forty and 13 subjects were randomized in the first-in-human and relative bioavailability studies, respectively. GLPG1690 was well tolerated, with no dose-limiting toxicity at all single and multiple doses. GLPG1690 was rapidly absorbed and eliminated, with a median t max  and mean t 1/2  of approximately 2 and 5 hours, respectively. GLPG1690 exposure increased with increasing dose (mean C max  , 0.09-19.01 µg/mL; mean AUC 0-inf  , 0.501-168 µg·h/mL, following single doses of GLPG1690 20-1500 mg). PD response, evidenced by rapid reduction in plasma lysophosphatidic acid (LPA) C18:2 levels, increased with increasing GLPG1690 plasma levels, plateauing at approximately 80% reduction in LPA C18:2 at around 0.6 µg/mL GLPG1690. Tablet and capsule formulations had similar PK profiles, and no clinically significant food effect was observed when comparing tablets taken in fed and fasted states. The safety, tolerability, and PK/PD profiles of GLPG1690 support continued clinical development for IPF.",2019,GLPG1690 is a novel autotaxin inhibitor in development for the treatment of idiopathic pulmonary fibrosis (IPF).,"['Healthy Subjects', 'Forty and 13 subjects', 'healthy subjects', 'idiopathic pulmonary fibrosis (IPF']","['GLPG1690', 'placebo', 'Autotaxin Inhibitor GLPG1690']","['GLPG1690 plasma levels', 'PD response', 'plasma lysophosphatidic acid (LPA) C18:2 levels', 'safety, tolerability, and PK/PD profiles', 'Safety, Pharmacokinetics, and Pharmacodynamics', 'safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}]","[{'cui': 'C4508131', 'cui_str': 'GLPG1690'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C4508131', 'cui_str': 'GLPG1690'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0024367', 'cui_str': 'Lysophosphatidic Acids'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}]",,0.129943,GLPG1690 is a novel autotaxin inhibitor in development for the treatment of idiopathic pulmonary fibrosis (IPF).,"[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'van der Aar', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Desrivot', 'Affiliation': 'Galapagos SASU, Romainville, France.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Dupont', 'Affiliation': 'Galapagos SASU, Romainville, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Heckmann', 'Affiliation': 'Galapagos SASU, Romainville, France.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Fieuw', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Stutvoet', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Fagard', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Van de Wal', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Helmer', 'Affiliation': 'Galapagos Biotech Limited, Cambridge, United Kingdom.'}]",Journal of clinical pharmacology,['10.1002/jcph.1424']
643,32072743,"Determination of HIV status and identification of incident HIV infections in a large, community-randomized trial: HPTN 071 (PopART).","INTRODUCTION


The HPTN 071 (PopART) trial evaluated the impact of an HIV combination prevention package that included ""universal testing and treatment"" on HIV incidence in 21 communities in Zambia and South Africa during 2013-2018. The primary study endpoint was based on the results of laboratory-based HIV testing for> 48,000 participants who were followed for up to three years. This report evaluated the performance of HIV assays and algorithms used to determine HIV status and identify incident HIV infections in HPTN 071, and assessed the impact of errors on HIV incidence estimates.
METHODS


HIV status was determined using a streamlined, algorithmic approach. A single HIV screening test was performed at centralized laboratories in Zambia and South Africa (all participants, all visits). Additional testing was performed at the HPTN Laboratory Center using antigen/antibody screening tests, a discriminatory test and an HIV RNA test. This testing was performed to investigate cases with discordant test results and confirm incident HIV infections.
RESULTS


HIV testing identified 978 seroconverter cases. This included 28 cases where the participant had acute HIV infection at the first HIV-positive visit. Investigations of cases with discordant test results identified cases where there was a participant or sample error (mixups). Seroreverter cases (errors where status changed from HIV infected to HIV uninfected, 0.4% of all cases) were excluded from the primary endpoint analysis. Statistical analysis demonstrated that exclusion of those cases improved the accuracy of HIV incidence estimates.
CONCLUSIONS


This report demonstrates that the streamlined, algorithmic approach effectively identified HIV infections in this large cluster-randomized trial. Longitudinal HIV testing (all participants, all visits) and quality control testing provided useful data on the frequency of errors and provided more accurate data for HIV incidence estimates.",2020,"Longitudinal HIV testing (all participants, all visits) and quality control testing provided useful data on the frequency of errors and provided more accurate data for HIV incidence estimates.","['21 communities in Zambia and South Africa during 2013-2018', '28 cases where the participant had acute HIV infection at the first HIV-positive visit']",[],['accuracy of HIV incidence estimates'],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0343752', 'cui_str': 'Acute human immunodeficiency virus seroconversion illness'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}]",[],"[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",48000.0,0.0658167,"Longitudinal HIV testing (all participants, all visits) and quality control testing provided useful data on the frequency of errors and provided more accurate data for HIV incidence estimates.","[{'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Eshleman', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Piwowar-Manning', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Ethan A', 'Initials': 'EA', 'LastName': 'Wilson', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Denni', 'Initials': 'D', 'LastName': 'Lennon', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Fogel', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Yaw', 'Initials': 'Y', 'LastName': 'Agyei', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Sullivan', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Weng', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Ayana', 'Initials': 'A', 'LastName': 'Moore', 'Affiliation': 'FHI360, Durham, NC, USA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Laeyendecker', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Kosloff', 'Affiliation': 'Zambart, University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Bwalya', 'Affiliation': 'Zambart, University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Maarman', 'Affiliation': 'Desmond Tutu TB Center, Department of Paediatrics and Child Health, Stellenbosch University, Stellenbosch, Western Cape, South Africa.'}, {'ForeName': 'Anneen', 'Initials': 'A', 'LastName': 'van Deventer', 'Affiliation': 'Stellenbosch University, Stellenbosch, Western Cape, South Africa.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Floyd', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bock', 'Affiliation': 'Desmond Tutu TB Center, Department of Paediatrics and Child Health, Stellenbosch University, Stellenbosch, Western Cape, South Africa.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Ayles', 'Affiliation': 'Zambart, University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fidler', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hayes', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Donnell', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the International AIDS Society,['10.1002/jia2.25452']
644,31718959,Surface treatments of a glass-fiber reinforced composite: Effect on the adhesion to a composite resin.,"PURPOSE


To compare the effect of different surface treatments (pre-treatments and bonding agents) on the bond strength between glass-fiber post and composite resin, and the topographic alterations of the treated post surface.
METHODS


Thirty-six glass-fiber blocks (12mm×10mm×8mm) were specifically manufactured for this study and randomly assigned into 12 groups considering two factors: 'pre-treatments' (-cleaning with 70% alcohol; air-abrasion with silica-coated aluminum oxide particles; 35% hydrogen peroxide) and type of 'bonding agent' (no bonding agent; application of Monobond Plus; RelyX Ceramic Primer; Single Bond Universal). After that, 6 cylindrical templates (1mm high×1mm Ø) were fixed on each block, filled with composite resin (n=18) and light-cured. Specimens were stored under 37°C for 24h and microshear tests (wire loop Ø=0.2mm) were performed. Topographic, roughness and failure analyses were also performed.
RESULTS


Different surface pre-treatments led to different topographic and roughness alterations; a higher surface alteration was noted after silica particles air-abrasion, while a slight surface alteration in the hydrogen peroxide group and a smooth pattern were observed in the cleaning group. The factors 'pre-treatments' (p<0.05), 'bonding agent' (p<0.05) and their interaction (p<0.05) influenced the bond strength. Silica coating, apart from bonding agent application, or Single Bond Universal application without pre-treatment promoted the highest bond values. The main failure type was adhesive at the resin-post interface.
CONCLUSIONS


In terms of pre-treatments, silica coating promotes the best bonding performance, but pre-treatments can be dispensable when applying Single Bond Universal.",2020,"Silica coating, apart from bonding agent application, or Single Bond Universal application without pre-treatment promoted the highest bond values.",[],"[""pre-treatments' (-cleaning with 70% alcohol; air-abrasion with silica-coated aluminum oxide particles; 35% hydrogen peroxide) and type of 'bonding agent' (no bonding agent; application of Monobond Plus; RelyX Ceramic Primer; Single Bond Universal""]","['Topographic, roughness and failure analyses']",[],"[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1302752', 'cui_str': 'Abrasion (morphologic abnormality)'}, {'cui': 'C0037098', 'cui_str': 'Silicon Dioxide'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0887544', 'cui_str': 'Aluminum Oxide (AlO2)'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0007742', 'cui_str': 'Ceramics'}, {'cui': 'C0759863', 'cui_str': 'single bond'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}]","[{'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",,0.0527095,"Silica coating, apart from bonding agent application, or Single Bond Universal application without pre-treatment promoted the highest bond values.","[{'ForeName': 'Ana C', 'Initials': 'AC', 'LastName': 'Cadore-Rodrigues', 'Affiliation': 'Post-Graduate Program in Oral Science, Division of Prosthetic Dentistry, Federal University of Santa Maria, Marechal Floriano Peixoto Street 1184, 97015-372 Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: anacadorerodrigues@gmail.com.'}, {'ForeName': 'Luís F', 'Initials': 'LF', 'LastName': 'Guilardi', 'Affiliation': 'Post-Graduate Program in Oral Science, Division of Prosthetic Dentistry, Federal University of Santa Maria, Marechal Floriano Peixoto Street 1184, 97015-372 Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: luisfguilardi@hotmail.com.'}, {'ForeName': 'Vinicius F', 'Initials': 'VF', 'LastName': 'Wandscher', 'Affiliation': 'Faculty of Odontology, Prosthodontics Unit, Franciscan University, Silva Jardim Street 1175, 97010-491 Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: viniwan@hotmail.com.'}, {'ForeName': 'Gabriel K R', 'Initials': 'GKR', 'LastName': 'Pereira', 'Affiliation': 'Post-Graduate Program in Dentistry, School of Dentistry, Meridional Faculty - IMED, Senador Pinheiro Street 304, 99070-220 Passo Fundo, Rio Grande do Sul State, Brazil. Electronic address: gabrielkrpereira@hotmail.com.'}, {'ForeName': 'Luiz F', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'Post-Graduate Program in Oral Science, Division of Prosthetic Dentistry, Federal University of Santa Maria, Marechal Floriano Peixoto Street 1184, 97015-372 Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: valandrolf@gmail.com.'}, {'ForeName': 'Marília P', 'Initials': 'MP', 'LastName': 'Rippe', 'Affiliation': 'Post-Graduate Program in Oral Science, Division of Prosthetic Dentistry, Federal University of Santa Maria, Marechal Floriano Peixoto Street 1184, 97015-372 Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: mariliarippe@mail.ufsm.br.'}]",Journal of prosthodontic research,['10.1016/j.jpor.2019.09.001']
645,31727561,Development and external validation of a nomogram to predict lymph node invasion after robot assisted radical prostatectomy.,"BACKGROUND


Prediction of lymph node invasion (LNI) after radical prostatectomy has been rarely assessed in robotically assisted laparoscopic radical prostatectomy (RALP) series. We aimed to develop and externally validate a pretreatment nomogram for the prediction of LNI following RALP in patients with high- and intermediate-risk prostate cancer.
METHODS


1654 RALP patients were prospectively collected between 2009 and 2016 from academic and community hospitals. We included patients with intermediate- and high-risk prostate cancer who underwent pelvic lymph node dissection (e-PLND). Logistic regression analysis was applied to construct a nomogram to predict LNI. Centers were randomly assigned to the training cohort (80%) and validation cohort (20%). The discriminative accuracies were evaluated by the areas under the curve and by the calibration plot. The net benefit of the nomogram to predict LNI was assessed by decision curve analysis and a cut-off was proposed.
RESULTS


In total, 14% of the patients in our cohort had pN1 disease. Applying logistic regression analysis, the following covariates were chosen to develop the nomogram: initial PSA, clinical T stage, biopsy Gleason sum, and proportion of positive biopsy cores. The nomogram showed a median discriminative accuracy of 73% and excellent calibration. The net benefit of the model ranged between 7% and 51% predicted risk of LNI. A cut-off to perform e-PLND was set at 7%. This would permit a 29% of avoidable e-PLND, missing 9.4% of patients with LNI.
CONCLUSIONS


We developed and externally validated a nomogram to predict LNI in patients treated with RALP from a prospective, multi-institutional, nationwide series. A risk of LNI > 7% is proposed as cut-off above which e-PLND is recommended.",2020,The nomogram showed a median discriminative accuracy of 73% and excellent calibration.,"['patients with high- and intermediate-risk prostate cancer', 'patients with intermediate- and high-risk prostate cancer who underwent pelvic lymph node dissection (e-PLND', '1654 RALP patients were prospectively collected between 2009 and 2016 from academic and community hospitals']",['robot assisted radical prostatectomy'],"['discriminative accuracies', 'median discriminative accuracy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0729595', 'cui_str': 'Pelvic lymph node structure (body structure)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}]","[{'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.0356131,The nomogram showed a median discriminative accuracy of 73% and excellent calibration.,"[{'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Tosco', 'Affiliation': 'Urology, University Hospitals Leuven, Leuven, Belgium; Humanitas University, Department of Biomedical Sciences, Via Rita Levi Montalcini 4, 20090 Pieve Emanuele - Milan, Italy. Electronic address: gaetan.devos@uzleuven.be.'}, {'ForeName': 'Gaëtan', 'Initials': 'G', 'LastName': 'Devos', 'Affiliation': 'Urology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'De Coster', 'Affiliation': 'Belgian Cancer Registry, Brussels, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Roumeguère', 'Affiliation': 'Department of Urology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Everaerts', 'Affiliation': 'Urology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Quackels', 'Affiliation': 'Department of Urology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dekuyper', 'Affiliation': 'Department of Urology, AZ Maria Middelares, Gent, Belgium.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Van Cleynenbreugel', 'Affiliation': 'Urology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Van Damme', 'Affiliation': 'Belgian Cancer Registry, Brussels, Belgium.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Van Eycken', 'Affiliation': 'Belgian Cancer Registry, Brussels, Belgium.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Ameye', 'Affiliation': 'Department of Urology, AZ Maria Middelares, Gent, Belgium.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Joniau', 'Affiliation': 'Urology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Urologic oncology,['10.1016/j.urolonc.2019.10.001']
646,31628873,Clinical and tomographic comparison of dental implants placed by guided virtual surgery versus conventional technique: A split-mouth randomized clinical trial.,"AIM


Our objective was to compare guided virtual surgery to conventional surgery in terms of angular deviation of single dental implants placed in the posterior mandible.
MATERIALS AND METHODS


Patients with bilateral homologous single teeth missing in the posterior mandible were eligible for this split-mouth randomized clinical trial. Cone beam computed tomography (CBCT) was performed for virtual planning of implant position and manufacturing of the stereolithographic guides. One week after the surgery, a second CBCT scan was superimposed to the initial planning. Primary endpoint was the angular deviation between virtual and clinical implant position. Secondary endpoints were linear deviations and patient-reported outcomes collected with a questionnaire.
RESULTS


Data from 12 patients were available for analysis. Angular deviation was significantly lower using stereolithographic guides as compared to conventional guides (2.2 ± 1.1° vs. 3.5 ± 1.6°, p = .042). Linear deviations were similar for both techniques in the coronal (2.34 ± 1.01 vs. 1.93 ± 0.95 mm) and apical (2.53 ± 1.11 vs. 2.19 ± 1.00 mm) dimensions (p ˃ .05). The selection of the surgical technique had no significant impact on the patient-reported outcomes.
CONCLUSION


Our data suggest that the angular discrepancy between the virtual and the clinical implant position is slightly lower when using stereolithographic guides as compared to conventional guides.",2020,"Angular deviation was significantly lower using stereolithographic guides as compared to conventional guides (2.2±1.1° vs 3.5±1.6°, p=0.042).","['Patients with bilateral homologous single teeth missing in the posterior mandible were eligible for this split-mouth randomized clinical trial', '12 patients were available for analysis']","['Cone beam computed tomography (CBCT', 'dental implants placed by guided virtual surgery versus conventional technique', 'guided virtual surgery to conventional surgery']","['angular deviation between virtual and clinical implant position', 'linear deviations and patient-reported outcomes collected with a questionnaire', 'Angular deviation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0457756', 'cui_str': 'Tooth absent (finding)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0024687', 'cui_str': 'Mandible'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0206034', 'cui_str': 'Clinical Trials, Randomized'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C1956110', 'cui_str': 'Cone-Beam Computerized Tomography'}, {'cui': 'C0011373', 'cui_str': 'Dental Implants'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.147607,"Angular deviation was significantly lower using stereolithographic guides as compared to conventional guides (2.2±1.1° vs 3.5±1.6°, p=0.042).","[{'ForeName': 'Gabriel L', 'Initials': 'GL', 'LastName': 'Magrin', 'Affiliation': 'Department of Dentistry, Center of Education and Research on Dental Implants, Federal University of Santa Catarina / UFSC, Florianopolis, Brazil.'}, {'ForeName': 'Stela N F', 'Initials': 'SNF', 'LastName': 'Rafael', 'Affiliation': 'Faculty of Dentistry, São Leopoldo Mandic, Campinas, Brazil.'}, {'ForeName': 'Bernardo B', 'Initials': 'BB', 'LastName': 'Passoni', 'Affiliation': 'Department of Dentistry, Center of Education and Research on Dental Implants, Federal University of Santa Catarina / UFSC, Florianopolis, Brazil.'}, {'ForeName': 'Ricardo S', 'Initials': 'RS', 'LastName': 'Magini', 'Affiliation': 'Department of Dentistry, Center of Education and Research on Dental Implants, Federal University of Santa Catarina / UFSC, Florianopolis, Brazil.'}, {'ForeName': 'Cesar A M', 'Initials': 'CAM', 'LastName': 'Benfatti', 'Affiliation': 'Department of Dentistry, Center of Education and Research on Dental Implants, Federal University of Santa Catarina / UFSC, Florianopolis, Brazil.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Gruber', 'Affiliation': 'Department of Oral Biology, Dental School of the Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Daiane C', 'Initials': 'DC', 'LastName': 'Peruzzo', 'Affiliation': 'Faculty of Dentistry, São Leopoldo Mandic, Campinas, Brazil.'}]",Journal of clinical periodontology,['10.1111/jcpe.13211']
647,30866088,Effects of empagliflozin on metabolic parameters in polycystic ovary syndrome: A randomized controlled study.,"BACKGROUND


Empagliflozin is a sodium-glucose-cotransporter-2 inhibitor that improves cardiovascular risk and promotes weight loss in patients with type-2 diabetes. Polycystic ovary syndrome (PCOS) is associated with obesity and increased cardiovascular risk; therefore, empagliflozin may be of benefit for these women. The aim of this study was to compare the effects of empagliflozin vs metformin on anthropometric and body composition, hormonal and metabolic parameters in women with PCOS.
MATERIALS AND METHODS


A randomized open-label study was conducted in women with PCOS who were randomized to either empagliflozin 25 mg (n = 19) or metformin 1500 mg (n = 20) daily for 12 weeks. The main outcomes assessed were changes in anthropometric and body composition, hormonal and metabolic parameters.
RESULTS


Univariate analysis showed significant differences in weight (empagliflozin: -1.4 ± 3.2% vs metformin: 1.2 ± 2.3%; P = 0.006), body mass index (empagliflozin: -1.4 ± 3.2% vs metformin: 1.1 ± 2.2%; P = 0.006), waist circumference (empagliflozin: -1.6 ± 2.8% vs metformin: 0.2 ± 2.1%; P = 0.029) and hip circumference (empagliflozin: -2.0 ± 3.0% vs metformin: 1.1 ± 1.9%; P = 0.001), basal metabolic rate (empagliflozin: -1.8 ± 2.9% vs metformin: 0.1 ± 1.9%, P = 0.024) and fat mass (empagliflozin: -0.7 ± 4.9% vs metformin, 3.2 ± 5.0%; P = 0.023) between the empagliflozin and the metformin groups. These differences were confirmed in linear regression analysis after adjustment for relevant covariates. There were no significant changes in hormonal or metabolic parameters between both groups.
CONCLUSION


There was a significant improvement in anthropometric parameters and body composition, in overweight and obese women with PCOS after 12 weeks of treatment with empagliflozin compared to metformin, although no changes were seen in hormonal or metabolic parameters.",2019,"There was a significant improvement in anthropometric parameters and body composition, in overweight and obese women with PCOS after 12 weeks of treatment with empagliflozin compared to metformin, although no changes were seen in hormonal or metabolic parameters.","['Polycystic ovary syndrome (PCOS', 'polycystic ovary syndrome', 'patients with type-2 diabetes', 'women with PCOS']","['empagliflozin', 'metformin', 'Empagliflozin', 'empagliflozin vs metformin', 'empagliflozin 25\xa0mg (n\xa0=\xa019) or metformin']","['waist circumference', 'basal metabolic rate', 'anthropometric parameters and body composition', 'hormonal or metabolic parameters', 'cardiovascular risk and promotes weight loss', 'body mass index', 'anthropometric and body composition, hormonal and metabolic parameters', 'metabolic parameters']","[{'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3848929', 'cui_str': 'empagliflozin 25 MG'}]","[{'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0678121', 'cui_str': 'Basal metabolic rate (observable entity)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",,0.0620096,"There was a significant improvement in anthropometric parameters and body composition, in overweight and obese women with PCOS after 12 weeks of treatment with empagliflozin compared to metformin, although no changes were seen in hormonal or metabolic parameters.","[{'ForeName': 'Zeeshan', 'Initials': 'Z', 'LastName': 'Javed', 'Affiliation': 'Department of Academic Diabetes, Endocrinology and Metabolism, Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Papageorgiou', 'Affiliation': 'Department of Academic Diabetes, Endocrinology and Metabolism, Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Harshal', 'Initials': 'H', 'LastName': 'Deshmukh', 'Affiliation': 'Department of Academic Diabetes, Endocrinology and Metabolism, Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Alan S', 'Initials': 'AS', 'LastName': 'Rigby', 'Affiliation': 'Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Unaiza', 'Initials': 'U', 'LastName': 'Qamar', 'Affiliation': 'Department of Pathology, Pakistan Kidney & Liver Institute and Research Centre, Lahore, Pakistan.'}, {'ForeName': 'Jehangir', 'Initials': 'J', 'LastName': 'Abbas', 'Affiliation': 'Department of Endocrinology and Diabetes, Pakistan Kidney & Liver Institute and Research Centre, Lahore, Pakistan.'}, {'ForeName': 'Amer Y', 'Initials': 'AY', 'LastName': 'Khan', 'Affiliation': 'Department of Medicine, Pakistan Kidney & Liver Institute and Research Centre, Lahore, Pakistan.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Kilpatrick', 'Affiliation': 'Department of Pathology, Sidra Medical and Research Center, Doha, Qatar.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Atkin', 'Affiliation': 'Weill Cornell Medical College Qatar, Doha, Qatar.'}, {'ForeName': 'Thozhukat', 'Initials': 'T', 'LastName': 'Sathyapalan', 'Affiliation': 'Department of Academic Diabetes, Endocrinology and Metabolism, Hull York Medical School, University of Hull, Hull, UK.'}]",Clinical endocrinology,['10.1111/cen.13968']
648,30983002,Validity and reliability of the reflux symptom score.,"OBJECTIVES/HYPOTHESIS


To develop and validate the Reflux Symptom Score (RSS), a self-administered patient-reported outcome questionnaire for patients with laryngopharyngeal reflux (LPR).
STUDY DESIGN


Prospective controlled study.
METHODS


A total of 113 patients with LPR were enrolled and treated with diet and 3 months of pantoprazole, alginate, and/or magaldrate depending on the LPR characteristics (acid, nonacid, or mixed). Eighty asymptomatic individuals completed the study. Patients and controls completed the RSS twice within a 7-day period to assess test-retest reliability. Internal consistency was measured using Cronbach's α for the RSS items in patients and controls. Validity was assessed by comparing the baseline RSS with the Reflux Symptom Index (RSI) and Voice Handicap Index (VHI). Seventy-seven patients completed the RSS at baseline and after 6 and 12 weeks of treatment to assess responsiveness to change. The RSS cutoff for determining the presence and absence of LPR was examined by receiver operating characteristic analysis.
RESULTS


Test-retest reliability (r s  = 0.921) and internal consistency reliability (α = 0.969) were high. RSS exhibited high external validity indicated by a significant correlation with the RSI (r s  = 0.831). Internal validity was excellent based on the higher RSS in patients compared with controls (P = .001). RSS, RSI, and VHI scores significantly improved from pre- to posttreatment, indicating a high responsiveness to change. RSS >13 can be considered suggestive of LPR-related symptoms. RSS was not influenced by the occurrence of gastroesophageal reflux disease, LPR subtypes, or patient characteristics.
CONCLUSIONS


RSS is a self-administered patient-reported outcome questionnaire that demonstrates high reliability and excellent criterion-based validity. RSS can be used in diagnosing and monitoring LPR disease.
LEVEL OF EVIDENCE


3b Laryngoscope, 130:E98-E107, 2020.",2020,Validity was assessed by comparing the baseline RSS with the Reflux Symptom Index (RSI) and Voice Handicap Index (VHI).,"['113 patients with LPR', 'Eighty asymptomatic individuals completed the study', 'patients with laryngopharyngeal reflux (LPR']","['pantoprazole, alginate, and/or magaldrate depending on the LPR characteristics (acid, nonacid, or mixed', 'RSS']","['Reflux Symptom Index (RSI) and Voice Handicap Index (VHI', 'Reflux Symptom Score (RSS', 'Validity and reliability of the reflux symptom score', 'Internal validity', 'RSS, RSI, and VHI scores', 'Internal consistency', 'internal consistency reliability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1168250', 'cui_str': 'Laryngopharyngeal Reflux'}]","[{'cui': 'C0081876', 'cui_str': 'pantoprazole'}, {'cui': 'C0102137', 'cui_str': 'alginate'}, {'cui': 'C0065512', 'cui_str': 'magaldrate'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C2699011', 'cui_str': 'Really Simple Syndication'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2699011', 'cui_str': 'Really Simple Syndication'}, {'cui': 'C0035036', 'cui_str': 'Reliability and Validity'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}]",113.0,0.0285135,Validity was assessed by comparing the baseline RSS with the Reflux Symptom Index (RSI) and Voice Handicap Index (VHI).,"[{'ForeName': 'Jérôme R', 'Initials': 'JR', 'LastName': 'Lechien', 'Affiliation': 'Research Committee of the Young Otolaryngologists of the International Federation of Oto-Rhino-Laryngological Societies (YO-IFOS), Marseille, France.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Bobin', 'Affiliation': 'Research Committee of the Young Otolaryngologists of the International Federation of Oto-Rhino-Laryngological Societies (YO-IFOS), Marseille, France.'}, {'ForeName': 'Vinciane', 'Initials': 'V', 'LastName': 'Muls', 'Affiliation': 'Department of Gastroenterology and Endoscopy, CHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Marie-Paule', 'Initials': 'MP', 'LastName': 'Thill', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, CHU Saint-Pierre, Brussels, Belgium.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Horoi', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, CHU Saint-Pierre, Brussels, Belgium.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Ostermann', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, CHU Saint-Pierre, Brussels, Belgium.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Huet', 'Affiliation': 'Research Committee of the Young Otolaryngologists of the International Federation of Oto-Rhino-Laryngological Societies (YO-IFOS), Marseille, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Harmegnies', 'Affiliation': 'Research Committee of the Young Otolaryngologists of the International Federation of Oto-Rhino-Laryngological Societies (YO-IFOS), Marseille, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Dequanter', 'Affiliation': 'Research Committee of the Young Otolaryngologists of the International Federation of Oto-Rhino-Laryngological Societies (YO-IFOS), Marseille, France.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Dapri', 'Affiliation': 'Department of Surgery, CHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Marie-Therese', 'Initials': 'MT', 'LastName': 'Maréchal', 'Affiliation': 'Department of Surgery, CHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Finck', 'Affiliation': 'Research Committee of the Young Otolaryngologists of the International Federation of Oto-Rhino-Laryngological Societies (YO-IFOS), Marseille, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Rodriguez Ruiz', 'Affiliation': 'Research Committee of the Young Otolaryngologists of the International Federation of Oto-Rhino-Laryngological Societies (YO-IFOS), Marseille, France.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Saussez', 'Affiliation': 'Research Committee of the Young Otolaryngologists of the International Federation of Oto-Rhino-Laryngological Societies (YO-IFOS), Marseille, France.'}]",The Laryngoscope,['10.1002/lary.28017']
649,29726361,A Randomized Trial of Mometasone Furoate 0.1% to Reduce High-Grade Acute Radiation Dermatitis in Breast Cancer Patients Receiving Postmastectomy Radiation.,"PURPOSE


A 2-arm, double-blinded randomized trial was conducted to evaluate the efficacy of 0.1% mometasone furoate (MF) versus Eucerin Original (E) cream in preventing the development of moderate to severe acute radiation dermatitis (ARD) in breast cancer patients receiving postmastectomy radiation (PMRT).
METHODS


Breast cancer patients undergoing chest wall with or without nodal radiation therapy (RT) (50 Gy) were eligible. Randomization (1:1) was to MF or E, applied twice daily from day 1 of PMRT to 14 days after PMRT. Patients were stratified by RT technique, body mass index, and reconstruction status. Daily bolus of 3 to 10 mm was applied in all patients. The primary endpoint was the development of provider-assessed grade ≥2 (Common Terminology Criteria for Adverse Events version 4.03) ARD with moist desquamation or any grade ≥3 dermatitis. Secondary endpoints were time to occurrence of maximum-grade dermatitis and patient-reported skin symptoms using a skin-related quality of life questionnaire, Skindex-16. Assessments were performed at baseline, weekly during PMRT, and 2 weeks after PMRT.
RESULTS


124 patients were enrolled between May 2013 and February 2016. Of those, 35% had pathologic stage III disease, 6% had cT4d disease, and 68% underwent reconstruction. Sixty percent received 3-dimensional conformal RT with photons only to the chest wall, 18% received electrons and photons, and 23% received inverse-planned intensity modulated RT. Groups were well balanced for age, skin type, and stage. The rate of moist desquamation was 54.8% in the entire cohort, with a significantly reduced incidence in the MF arm than in the E arm (43.8% vs 66.7%; P = .012). The MF arm had a lower incidence of maximum skin toxicities (P = .036) and longer time to development of grade 3 dermatitis (46 days vs 35.5 days, respectively; P ≤ .001). There was no difference in patient-reported skin outcomes between arms.
CONCLUSIONS


Breast cancer patients receiving MF during PMRT experienced significantly reduced rates of moist desquamation in comparison with a control cream.",2018,"The MF arm had a lower incidence of maximum skin toxicities (P = .036) and longer time to development of grade 3 dermatitis (46 days vs 35.5 days, respectively; P ≤ .001).","['moderate to severe acute radiation dermatitis (ARD) in breast cancer patients receiving postmastectomy radiation (PMRT', 'Breast cancer patients undergoing chest wall with or without nodal radiation therapy (RT) (50\xa0Gy) were eligible', 'Breast cancer patients receiving MF during', 'Breast Cancer Patients Receiving Postmastectomy Radiation', '124 patients were enrolled between May 2013 and February 2016']","['PMRT', 'mometasone furoate (MF) versus Eucerin Original (E) cream', 'Mometasone Furoate', '3-dimensional conformal RT', 'inverse-planned intensity modulated RT']","['High-Grade Acute Radiation Dermatitis', 'patient-reported skin outcomes', 'time to occurrence of maximum-grade dermatitis and patient-reported skin symptoms using a skin-related quality of life questionnaire, Skindex-16', 'pathologic stage III disease', 'maximum skin toxicities', 'development of provider-assessed grade ≥2 (Common Terminology Criteria for Adverse Events version 4.03', 'rates of moist desquamation', 'longer time to development of grade 3 dermatitis', 'rate of moist desquamation']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0263606', 'cui_str': 'Early radiation dermatitis (disorder)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205076', 'cui_str': 'Chest Wall'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}]","[{'cui': 'C0066700', 'cui_str': 'mometasone furoate'}, {'cui': 'C0164056', 'cui_str': 'eucerin'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0439850', 'cui_str': 'Inverse (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}]","[{'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0263606', 'cui_str': 'Early radiation dermatitis (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0586407', 'cui_str': 'Skin symptom'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1320480', 'cui_str': 'Pathologic stage'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1516728', 'cui_str': 'CTCAE (Common Terminology Criteria for Adverse Events)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0205381', 'cui_str': 'Wet (qualifier value)'}, {'cui': 'C0237849', 'cui_str': 'Scaling of skin'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",124.0,0.0538623,"The MF arm had a lower incidence of maximum skin toxicities (P = .036) and longer time to development of grade 3 dermatitis (46 days vs 35.5 days, respectively; P ≤ .001).","[{'ForeName': 'Alice Y', 'Initials': 'AY', 'LastName': 'Ho', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA. Electronic address: Alice.Ho@mgh.harvard.edu.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Olm-Shipman', 'Affiliation': 'Department of Oncology Access, University of Colorado Health, Aurora, Colorado.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Chun Ting', 'Initials': 'CT', 'LastName': 'Siu', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Wilgucki', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Anh', 'Initials': 'A', 'LastName': 'Phung', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Brittany B', 'Initials': 'BB', 'LastName': 'Arnold', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Marypat', 'Initials': 'M', 'LastName': 'Porinchak', 'Affiliation': 'Department of Nursing, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Lacouture', 'Affiliation': 'Department of Dermatology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Beryl', 'Initials': 'B', 'LastName': 'McCormick', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Simon N', 'Initials': 'SN', 'LastName': 'Powell', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Daphna Y', 'Initials': 'DY', 'LastName': 'Gelblum', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2018.02.006']
650,30947606,RETRACTED: A randomized comparison of ultrasound-guided versus landmark-based corticosteroid injection for trigger finger.,,2020,No significant differences between the two groups were observed in pain or QuickDASH scores at 24 weeks of follow-up.,['One hundred and four patients who had been diagnosed with trigger finger and were to be treated by corticosteroid injection'],"['Ultrasound-guided steroid injection', 'landmark-based injection and the other for ultrasound-guided injection', 'ultrasound-guided versus landmark-based corticosteroid injection']","['pain or QuickDASH scores', 'adverse events', 'visual analogue scale score for pain and the Quick Disability of the Arm, Shoulder, and Hand (QuickDASH) score']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0158328', 'cui_str': 'Trigger Digits'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C4305575', 'cui_str': 'Ultrasonography guided steroid injection'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]",,0.0500322,No significant differences between the two groups were observed in pain or QuickDASH scores at 24 weeks of follow-up.,"[{'ForeName': 'Young Hak', 'Initials': 'YH', 'LastName': 'Roh', 'Affiliation': 'Department of Orthopaedic Surgery, Ewha Womans University Medical Center, Ewha Womans University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sangwoo', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Ewha Womans University Medical Center, Ewha Womans University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hyun Sik', 'Initials': 'HS', 'LastName': 'Gong', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Sungnam, South Korea.'}, {'ForeName': 'Goo Hyun', 'Initials': 'GH', 'LastName': 'Baek', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea.'}]","The Journal of hand surgery, European volume",['10.1177/1753193419839892']
651,29948856,Diet associated with exercise improves baroreflex control of sympathetic nerve activity in metabolic syndrome and sleep apnea patients.,"PURPOSE


We tested the hypothesis that (i) diet associated with exercise would improve arterial baroreflex (ABR) control in metabolic syndrome (MetS) patients with and without obstructive sleep apnea (OSA) and (ii) the effects of this intervention would be more pronounced in patients with OSA.
METHODS


Forty-six MetS patients without (noOSA) and with OSA (apnea-hypopnea index, AHI > 15 events/h) were allocated to no treatment (control, C) or hypocaloric diet (- 500 kcal/day) associated with exercise (40 min, bicycle exercise, 3 times/week) for 4 months (treatment, T), resulting in four groups: noOSA-C (n = 10), OSA-C (n = 12), noOSA-T (n = 13), and OSA-T (n = 11). Muscle sympathetic nerve activity (MSNA), beat-to-beat BP, and spontaneous arterial baroreflex function of MSNA (ABR MSNA , gain and time delay) were assessed at study entry and end.
RESULTS


No significant changes occurred in C groups. In contrast, treatment in both patients with and without OSA led to a significant decrease in weight (P < 0.05) and the number of MetS factors (P = 0.03). AHI declined only in the OSA-T group (31 ± 5 to 17 ± 4 events/h, P < 0.05). Systolic BP decreased in both treatment groups, and diastolic BP decreased significantly only in the noOSA-T group. Treatment decreased MSNA in both groups. Compared with baseline, ABR MSNA  gain increased in both OSA-T (13 ± 1 vs. 24 ± 2 a.u./mmHg, P = 0.01) and noOSA-T (27 ± 3 vs. 37 ± 3 a.u./mmHg, P = 0.03) groups. The time delay of ABR MSNA  was reduced only in the OSA-T group (4.1 ± 0.2 s vs. 2.8 ± 0.3 s, P = 0.04).
CONCLUSIONS


Diet associated with exercise improves baroreflex control of sympathetic nerve activity and MetS components in patients with MetS regardless of OSA.",2019,"AHI declined only in the OSA-T group (31 ± 5 to 17 ± 4 events/h, P < 0.05).","['metabolic syndrome (MetS) patients with and without obstructive sleep apnea (OSA) and (ii', 'Forty-six MetS patients without (noOSA) and with OSA (apnea-hypopnea index, AHI >\u200915\xa0events/h', 'metabolic syndrome and sleep apnea patients', 'patients with MetS regardless of OSA']","['hypocaloric diet (-\u2009500\xa0kcal/day) associated with exercise (40\xa0min, bicycle exercise']","['AHI', 'Muscle sympathetic nerve activity (MSNA), beat-to-beat BP, and spontaneous arterial baroreflex function of MSNA (ABR MSNA , gain and time delay', 'MSNA', 'time delay of ABR MSNA', 'Systolic BP', 'baroreflex control of sympathetic nerve activity and MetS components', 'diastolic BP', 'arterial baroreflex (ABR) control', 'number of MetS factors', 'ABR MSNA  gain', 'weight']","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0456649', 'cui_str': 'kcal/day'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure (body structure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0206162', 'cui_str': 'Reflex, Baroreceptor'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",46.0,0.0133989,"AHI declined only in the OSA-T group (31 ± 5 to 17 ± 4 events/h, P < 0.05).","[{'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Toschi-Dias', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, SP, Brazil. edgardias@usp.br.'}, {'ForeName': 'Ivani C', 'Initials': 'IC', 'LastName': 'Trombetta', 'Affiliation': 'Universidade Nove de Julho, São Paulo, SP, Brazil.'}, {'ForeName': 'Valdo J D', 'Initials': 'VJD', 'LastName': 'Silva', 'Affiliation': 'Biological Sciences Institute, Triangulo Mineiro Federal University, Uberaba, MG, Brazil.'}, {'ForeName': 'Cristiane', 'Initials': 'C', 'LastName': 'Maki-Nunes', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, SP, Brazil.'}, {'ForeName': 'Felipe X', 'Initials': 'FX', 'LastName': 'Cepeda', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, SP, Brazil.'}, {'ForeName': 'Maria Janieire N N', 'Initials': 'MJNN', 'LastName': 'Alves', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, SP, Brazil.'}, {'ForeName': 'Glauce L', 'Initials': 'GL', 'LastName': 'Carvalho', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, SP, Brazil.'}, {'ForeName': 'Luciano F', 'Initials': 'LF', 'LastName': 'Drager', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, SP, Brazil.'}, {'ForeName': 'Geraldo', 'Initials': 'G', 'LastName': 'Lorenzi-Filho', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, SP, Brazil.'}, {'ForeName': 'Carlos E', 'Initials': 'CE', 'LastName': 'Negrão', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, SP, Brazil.'}, {'ForeName': 'Maria Urbana P B', 'Initials': 'MUPB', 'LastName': 'Rondon', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, SP, Brazil.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-018-1675-x']
652,30811872,"Ciprofloxacin for BK viremia prophylaxis in kidney transplant recipients: Results of a prospective, double-blind, randomized, placebo-controlled trial.","In kidney transplantation, BK virus infection has historically resulted in high rates of graft dysfunction and graft loss. Unlike other opportunistic infections, no therapies have been shown to prevent BK. The purpose of the current study was to evaluate the safety and efficacy of ciprofloxacin for the prevention of BK viremia in kidney transplant recipients. Two hundred kidney transplant recipients were enrolled in a prospective, randomized, double-blind, placebo-controlled trial comparing a 3-month course of ciprofloxacin (n = 133) vs placebo (n = 67) for the prevention of BK viremia. The primary endpoint of BK viremia at month 6 posttransplant occurred in 25 (18.8%) patients in the ciprofloxacin group and 5 (7.5%) in the placebo group (P = .03). Higher rates of BK viremia (23.3% vs 11.9%; P = .06) and BK nephropathy (5.8% vs 1.5%; P = .26) remained at 12 months in the ciprofloxacin group. Ciprofloxacin use was associated with a significantly higher rate of fluoroquinolone-resistant gram-negative infections (83.3% vs 50%; P = .04). A 3-month course of ciprofloxacin was ineffective at preventing BK viremia in kidney transplant recipients and was associated with an increased risk of fluoroquinolone-resistant infections. Clinical trial registration number: NCT01789203.",2019,Higher rates of BK viremia (23.3% vs 11.9%; P = .06) and BK nephropathy (5.8% vs 1.5%; P = .26) remained at 12 months in the ciprofloxacin group.,"['Two hundred kidney transplant recipients', 'kidney transplant recipients']","['Ciprofloxacin', 'ciprofloxacin', 'placebo']","['safety and efficacy', 'BK viremia at month 6 posttransplant', 'BK viremia', 'rate of fluoroquinolone-resistant gram-negative infections', 'BK nephropathy']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}]","[{'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0949665', 'cui_str': 'Fluoroquinolones'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}]",,0.510228,Higher rates of BK viremia (23.3% vs 11.9%; P = .06) and BK nephropathy (5.8% vs 1.5%; P = .26) remained at 12 months in the ciprofloxacin group.,"[{'ForeName': 'Samir J', 'Initials': 'SJ', 'LastName': 'Patel', 'Affiliation': 'Department of Pharmacy, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Knight', 'Affiliation': 'Department of Surgery, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Samantha A', 'Initials': 'SA', 'LastName': 'Kuten', 'Affiliation': 'Department of Pharmacy, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Graviss', 'Affiliation': 'Department of Pathology and Genomic Medicine, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Duc T', 'Initials': 'DT', 'LastName': 'Nguyen', 'Affiliation': 'Department of Pathology and Genomic Medicine, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Linda W', 'Initials': 'LW', 'LastName': 'Moore', 'Affiliation': 'Department of Surgery, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Musick', 'Affiliation': 'Department of Pharmacy, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Ahmed Osama', 'Initials': 'AO', 'LastName': 'Gaber', 'Affiliation': 'Department of Surgery, Houston Methodist Hospital, Houston, Texas.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.15328']
653,30975047,The impact of telehealth care on health-related quality of life of patients with heart failure: Results from the Danish TeleCare North heart failure trial.,"AIM


The aim of this study was to assess the impact on health-related quality of life (HRQoL) of a telehealth care solution compared with usual practice of patients with heart failure (HF).
METHODS


A randomized controlled trial with a telehealth care solution (Telekit) as the intervention (with a focus on self-empowerment achieved by engaging patients in their own illness through self-monitoring) combined with usual care and usual care as the control. The primary outcome was a change in HRQoL as measured by the Short Form-36 (SF-36) questionnaire Physical Component Summary (PCS) score. Secondary outcomes were changes in HRQoL as measured by the SF-36 questionnaire Mental Component Summary (MSC) score and the HF disease-specific questionnaire Kansas City Cardiomyopathy Questionnaire 12 (KCCQ12) score, all of which were assessed from baseline to approximately 12 months' follow-up between the two groups. Outcomes were assessed via unadjusted and adjusted analyses.
RESULTS


At baseline, 299 (145 interventions, 154 controls) patients were enrolled. In the primary analysis ( n  = 299), the adjusted intervention effects were PCS -0.81 (95% CI -2.7-1.1), MCS 4.66 (95% CI 1.8-7.5) and KCCQ12 3.67 (95% CI -0.7-8.1). Only the change in MCS was statistically significant. An unadjusted analysis replicated the primary analysis. Complete case analyses ( n  = 193) generally resulted in a lower intervention effect on the PCS score, but the difference remained statistically insignificant.
CONCLUSIONS


Only the MCS score was significantly higher in the telehealth care group compared to the control group.ClinicalTrials.gov (NCT02860013), July 28, 2016.",2020,"In the primary analysis ( n = 299), the adjusted intervention effects were PCS -0.81","['patients with heart failure (HF', '299 (145 interventions, 154 controls) patients were enrolled', 'patients with heart failure']","['telehealth care', 'telehealth care solution (Telekit']","['MCS score', 'health-related quality of life (HRQoL', 'change in HRQoL as measured by the Short Form-36 (SF-36) questionnaire Physical Component Summary (PCS) score', 'MCS', 'Cardiomyopathy Questionnaire 12 (KCCQ12) score', 'PCS score', 'changes in HRQoL as measured by the SF-36 questionnaire Mental Component Summary (MSC) score and the HF disease-specific questionnaire Kansas City']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]",,0.167949,"In the primary analysis ( n = 299), the adjusted intervention effects were PCS -0.81","[{'ForeName': 'Simon L', 'Initials': 'SL', 'LastName': 'Cichosz', 'Affiliation': 'Department of Health Science and Technology, Aalborg University, Denmark.'}, {'ForeName': 'Flemming W', 'Initials': 'FW', 'LastName': 'Udsen', 'Affiliation': 'Department of Health Science and Technology, Aalborg University, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Hejlesen', 'Affiliation': 'Department of Health Science and Technology, Aalborg University, Denmark.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19832713']
654,30895203,Indirect Effect of Azithromycin Use on the Intestinal Microbiome Diversity of Untreated Children: A Randomized Trial.,Cohabiting children may share components of their intestinal microbiome. We evaluated whether receipt of azithromycin in one sibling confers changes to the intestinal microbiome in an untreated sibling compared with placebo in a randomized controlled trial. We found no evidence of an indirect effect of antibiotic use in cohabiting children.  Clinical Trials Registrations:  NCT03187834.,2019,We found no evidence of an indirect effect of antibiotic use in cohabiting children.  ,"['cohabiting children', 'Untreated Children']","['Azithromycin', 'azithromycin', 'placebo']",[],"[{'cui': 'C0221179', 'cui_str': 'Cohabiting (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0956996,We found no evidence of an indirect effect of antibiotic use in cohabiting children.  ,"[{'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Francis I. Proctor Foundation, San Francisco.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sié', 'Affiliation': 'Centre de Recherche en Sante de Nouna, Burkina Faso.'}, {'ForeName': 'Boubacar', 'Initials': 'B', 'LastName': 'Coulibaly', 'Affiliation': 'Centre de Recherche en Sante de Nouna, Burkina Faso.'}, {'ForeName': 'Lucienne', 'Initials': 'L', 'LastName': 'Ouermi', 'Affiliation': 'Centre de Recherche en Sante de Nouna, Burkina Faso.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Dah', 'Affiliation': 'Centre de Recherche en Sante de Nouna, Burkina Faso.'}, {'ForeName': 'Charlemagne', 'Initials': 'C', 'LastName': 'Tapsoba', 'Affiliation': 'Centre de Recherche en Sante de Nouna, Burkina Faso.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Heidelberg Institute for Global Health, Heidelberg University, Germany.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lebas', 'Affiliation': 'Francis I. Proctor Foundation, San Francisco.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Arzika', 'Affiliation': 'The Carter Center Niger, Niamey.'}, {'ForeName': 'Susie', 'Initials': 'S', 'LastName': 'Cummings', 'Affiliation': 'Francis I. Proctor Foundation, San Francisco.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': 'Francis I. Proctor Foundation, San Francisco.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I. Proctor Foundation, San Francisco.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I. Proctor Foundation, San Francisco.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Doan', 'Affiliation': 'Francis I. Proctor Foundation, San Francisco.'}]",Open forum infectious diseases,['10.1093/ofid/ofz061']
655,30559085,Effect of sleep restriction on somatosensory sensitivity including occlusal sensation in the orofacial area.,"PURPOSE


To investigate the effect of sleep restriction on somatosensory sensitivity related to occlusion.
METHODS


Twelve healthy participants participated in an experimental voluntary total sleep restriction (SR) study. In a study design, they were invited to sleep as usual, normal sleep (NS) or to restrict their sleep for four nights. Following the SR night, participants were followed for 3 consecutive days including the 2 sleep nights. In NS experiment, all participants were instructed to maintain NS both nights. During all nights, actigraphy data were collected and total sleep time was estimated. On days before and after sleep conditions, all participants underwent measurements of tactile detection threshold (TDT), interocclusal detection threshold (IDT), perception of unpleasantness (POU), and the Epworth sleepiness scale (ESS).
RESULTS


As expected, total sleep time on the first night in SR experiment was significantly shorter than on the second night in SR experiment and on the first night in NS experiment (P<0.05). ESS values on Day-2 following SR experiment were significantly higher than on Day-1 and Day-3 in SR experiment and Day-2 in NS experiment (P<0.05). There were no significant differences in TDT and IDT between each day at each measurement point in both experiments. POU was significantly lower on Day-2 in SR experiment than on Day-1 and Day-3 in SR experiment and on Day-2 in NS experiment (P<0.05).
CONCLUSIONS


The present results suggest that SR affects to occlusal sensation related to POU.",2019,ESS values on Day-2 following SR experiment were significantly higher than on Day-1 and Day-3 in SR experiment and Day-2 in NS experiment (P<0.05).,"['Twelve healthy participants participated in an experimental voluntary total sleep restriction (SR) study', 'occlusal sensation in the orofacial area']",['sleep restriction'],"['tactile detection threshold (TDT), interocclusal detection threshold (IDT), perception of unpleasantness (POU), and the Epworth sleepiness scale (ESS', 'POU', 'TDT and IDT', 'total sleep time']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1947917', 'cui_str': 'Occluded (qualifier value)'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0439815', 'cui_str': 'Tactile (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",12.0,0.0126606,ESS values on Day-2 following SR experiment were significantly higher than on Day-1 and Day-3 in SR experiment and Day-2 in NS experiment (P<0.05).,"[{'ForeName': 'Hideta', 'Initials': 'H', 'LastName': 'Nishimori', 'Affiliation': 'Division of Oral Function and Rehabilitation, Department of Oral Health Science, Nihon University School of Dentistry at Matsudo, Matsudo, Japan. Electronic address: hideta.nishimori@gmail.com.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Iida', 'Affiliation': 'Division of Oral Function and Rehabilitation, Department of Oral Health Science, Nihon University School of Dentistry at Matsudo, Matsudo, Japan.'}, {'ForeName': 'Hirona', 'Initials': 'H', 'LastName': 'Kamiyama', 'Affiliation': 'Division of Oral Function and Rehabilitation, Department of Oral Health Science, Nihon University School of Dentistry at Matsudo, Matsudo, Japan.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Honda', 'Affiliation': 'Division of Oral Function and Rehabilitation, Department of Oral Health Science, Nihon University School of Dentistry at Matsudo, Matsudo, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Masuda', 'Affiliation': 'Division of Oral Function and Rehabilitation, Department of Oral Health Science, Nihon University School of Dentistry at Matsudo, Matsudo, Japan.'}, {'ForeName': 'Antoon', 'Initials': 'A', 'LastName': 'De Laat', 'Affiliation': 'Department of Oral Health Sciences, KU Leuven, Leuven, Belgium; Department of Dentistry, University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Komiyama', 'Affiliation': 'Division of Oral Function and Rehabilitation, Department of Oral Health Science, Nihon University School of Dentistry at Matsudo, Matsudo, Japan.'}]",Journal of prosthodontic research,['10.1016/j.jpor.2018.11.005']
656,30931594,Cognitive-Behavioral Therapy for Anxiety in Parkinson's Disease.,"Parkinson's disease (PD) is characterized by motor symptoms, but nonmotor symptoms also significantly impair daily functioning and reduce quality of life. Anxiety is prevalent and debilitating in PD, but remains understudied and undertreated. Much affective research in PD focuses on depression rather than anxiety, and as such, there are no evidence-based treatments for anxiety in this population. Cognitive-behavioral therapy (CBT) has shown promise for treating depression in PD and may be efficacious for anxiety. This exploratory study implemented a multiple-baseline single-case experimental design to evaluate the utility and feasibility of CBT for individuals with PD who also met criteria for a DSM-5 anxiety disorder ( n  = 9). Participants were randomized to a 2-, 4-, or 6-week baseline phase, followed by 12 CBT sessions, and two post treatment assessments (immediately post treatment and 6-week follow-up). Multiple outcome measures of anxiety and depression were administered weekly during baseline and intervention. Weekly CBT sessions were conducted in-person ( n  = 5) or via secure videoconferencing ( n  = 4). At post treatment, seven of the nine participants showed significant reductions in anxiety and/or depression, with changes functionally related to treatment and most improvements maintained at 6-week follow-up. Effects of CBT on secondary outcomes varied across participants, with preliminary evidence for reduction in fear of falling. Adherence and retention were high, as were treatment satisfaction and acceptability. The findings of this pilot study provide preliminary evidence for the utility of CBT as a feasible treatment for anxiety and comorbid depressive symptoms in PD and highlight the potential of telehealth interventions for mood in this population.",2020,"Adherence and retention were high, as were treatment satisfaction and acceptability.","['individuals with PD who also met criteria for a DSM-5 anxiety disorder ( n = 9', ""Parkinson's Disease"", ""Parkinson's disease (PD""]","['secure videoconferencing', 'CBT', 'Cognitive-behavioral therapy (CBT', 'Cognitive-Behavioral Therapy']","['Adherence and retention', 'anxiety and depression', 'fear of falling', 'quality of life', 'anxiety and/or depression']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling (finding)'}, {'cui': 'C0034380'}]",,0.0349592,"Adherence and retention were high, as were treatment satisfaction and acceptability.","[{'ForeName': 'Gretchen O', 'Initials': 'GO', 'LastName': 'Reynolds', 'Affiliation': 'Boston University, MA, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Saint-Hilaire', 'Affiliation': 'Boston University Medical Center, MA, USA.'}, {'ForeName': 'Cathi A', 'Initials': 'CA', 'LastName': 'Thomas', 'Affiliation': 'Boston University Medical Center, MA, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Barlow', 'Affiliation': 'Boston University, MA, USA.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Cronin-Golomb', 'Affiliation': 'Boston University, MA, USA.'}]",Behavior modification,['10.1177/0145445519838828']
657,31926340,"Effects of Apremilast, an Oral Inhibitor of Phosphodiesterase 4, in a Randomized Trial of Patients With Active Ulcerative Colitis.","BACKGROUND & AIMS


New oral therapeutic agents are needed for patients with ulcerative colitis (UC) who are unresponsive or intolerant to conventional therapy.
METHODS


We performed a double-blind, phase 2 trial of adults with active UC for 3 months or more who were naïve to biologic therapy or had been failed by, could not tolerate, or had contraindications to conventional therapies. The study was performed at 61 sites in 14 countries (screening from January 2015 through May 2017). Patients were randomly assigned to groups given apremilast 30 mg (n = 57), apremilast 40 mg (n = 55), or placebo (n = 58) twice daily for 12 weeks; patients were then randomly assigned to groups that received apremilast, 30 or 40 mg twice daily, for an additional 40 weeks. Endoscopies were performed and biopsies were collected during the screening phase, at week 12, and at week 52. Blood and fecal samples were also collected and analyzed throughout the study. The primary endpoint was clinical remission at week 12, defined as a total Mayo score of 2 or less, with no individual subscore above 1.
RESULTS


Clinical remission was achieved at week 12 by 31.6% of patients in the 30 mg apremilast group and 12.1% of patients in the placebo group (P = .01). However, only 21.8% of patients in the 40 mg apremilast group achieved clinical remission at week 12 (P = .27 compared with placebo). Differences in clinical remission between the 30 mg and 40 mg apremilast groups were associated with differences in endoscopic improvement. Both apremilast groups had similar improvements from baseline in Mayo score components (stool frequency score, rectal bleeding score, physician's global assessment). The 30 mg and 40 mg apremilast groups had greater median percent reductions in C-reactive protein (measured by a high-sensitivity blood test) and fecal calprotectin through week 12 than the placebo group. At week 52, clinical remission was achieved by 40.4% of patients initially assigned to the apremilast 30 mg group and 32.7% of patients initially assigned to the apremilast 40 mg group. The most frequent apremilast-associated adverse events were headache and nausea.
CONCLUSIONS


Although the primary endpoint of clinical remission was not met in this phase 2 trial, a greater proportion of patients with active UC who received apremilast (30 mg or 40 mg) had improvements in clinical and endoscopic features, and markers of inflammation, at 12 weeks. Clinical remission was maintained to week 52 in up to 40% of patients who continued apremilast until that time point. ClinicalTrials.gov no: NCT02289417.",2020,Clinical remission was maintained to week 52 in up to 40% of patients who continued apremilast until that time point.,"['61 sites in 14 countries (screening from January 2015 through May 2017', 'adults with active UC for 3 months or more who were naïve to biologic therapy or had been failed by, could not tolerate, or had contraindications to conventional therapies', 'patients with ulcerative colitis (UC) who are unresponsive or intolerant to conventional therapy', 'Patients With Active Ulcerative Colitis']",['placebo'],"['clinical and endoscopic features, and markers of inflammation', 'total Mayo score of 2 or less, with no individual subscore above 1', 'clinical remission', 'Clinical remission', 'median percent reductions in C-reactive protein', 'fecal calprotectin', ""Mayo score components (stool frequency score, rectal bleeding score, physician's global assessment"", 'Blood and fecal samples', 'headache and nausea', 'endoscopic improvement']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0005527', 'cui_str': 'Biologic Therapy'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}, {'cui': 'C0237284', 'cui_str': 'Unresponsive'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0454788', 'cui_str': 'Mayo (geographic location)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0005768'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",,0.208769,Clinical remission was maintained to week 52 in up to 40% of patients who continued apremilast until that time point.,"[{'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Danese', 'Affiliation': 'Humanitas Clinical and Research Center - IRCCS, Milan, Italy; Humanitas University, Department of Biomedical Sciences, Milan, Italy. Electronic address: silvio.danese@humanitasresearch.it.'}, {'ForeName': 'Markus F', 'Initials': 'MF', 'LastName': 'Neurath', 'Affiliation': 'Department of Internal Medicine, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Kopoń', 'Affiliation': 'Department of Gastroenterology, Toruńskie Centrum Gastrologiczne Gastromed, Toruń, Poland.'}, {'ForeName': 'Salam F', 'Initials': 'SF', 'LastName': 'Zakko', 'Affiliation': 'Connecticut Clinical Research Institute, Bristol Hospital, Bristol, Connecticut.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Simmons', 'Affiliation': 'West Gastroenterology Medical Group, Los Angeles, California.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Fogel', 'Affiliation': 'Clinical Research Institute of Michigan, Digestive Health Center of Michigan, Chesterfield, Michigan.'}, {'ForeName': 'Corey A', 'Initials': 'CA', 'LastName': 'Siegel', 'Affiliation': 'Department of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.'}, {'ForeName': 'Remo', 'Initials': 'R', 'LastName': 'Panaccione', 'Affiliation': 'Inflammatory Bowel Disease Clinic, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Xiaojiang', 'Initials': 'X', 'LastName': 'Zhan', 'Affiliation': 'Clinical Research, Celgene Corporation, Summit, New Jersey.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Usiskin', 'Affiliation': 'Clinical Research, Celgene Corporation, Summit, New Jersey.'}, {'ForeName': 'Denesh', 'Initials': 'D', 'LastName': 'Chitkara', 'Affiliation': 'Clinical Research, Celgene Corporation, Summit, New Jersey.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2019.12.032']
658,30956160,Masticatory function and bite force of mandibular single-implant overdentures and complete dentures: a randomized crossover control study.,"PURPOSE


The study aimed to compare the mixing ability (MA), comminuting ability (CA), and maximum bite force (MBF) of single-implant overdentures (IODs) and clinically acceptable complete dentures (CDs) through a randomized crossover control trial.
METHODS


New CDs were fabricated for 22 patients. One implant was inserted in the middle of the symphyseal region for each patient. The patients were randomly allocated into two groups: group IC received an IOD, whereas group CI received a CD, for 2 months; the treatments were interchanged for the next 2 months. The MA, CA, and MBF were evaluated with the old CDs, new CDs (at the end of CD treatment period), and IODs (at the end of IOD treatment period).
RESULTS


The MA, CA, and MBF of the IODs were significantly higher than those of the old and new CDs (p < 0.01). New CDs only showed a significant improvement in MA (p < 0.05), while there were no significant differences in CA and MBF between the old and new CDs.
CONCLUSIONS


Compared with the CD, IOD is more effective in restoring the MA, CA, and MBF of edentulous mandibles.",2019,"New CDs only showed a significant improvement in MA (p < 0.05), while there were no significant differences in CA and MBF between the old and new CDs.
","['mandibular single-implant overdentures and complete dentures', '22 patients']",['single-implant overdentures (IODs) and clinically acceptable complete dentures (CDs'],"['CA and MBF', 'MA, CA, and MBF of the IODs', 'Masticatory function and bite force', 'MA', 'mixing ability (MA), comminuting ability (CA), and maximum bite force (MBF', 'MA, CA, and MBF']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0011459', 'cui_str': 'Overdenture'}, {'cui': 'C0011455', 'cui_str': 'Denture, Complete'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0011459', 'cui_str': 'Overdenture'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0011455', 'cui_str': 'Denture, Complete'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005654', 'cui_str': 'Occlusal Force'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0476171', 'cui_str': 'Fractures, Comminuted'}]",,0.0214393,"New CDs only showed a significant improvement in MA (p < 0.05), while there were no significant differences in CA and MBF between the old and new CDs.
","[{'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Lam Vo', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Kanazawa', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan. Electronic address: m.kanazawa.gerd@tmd.ac.jp.'}, {'ForeName': 'Khaing', 'Initials': 'K', 'LastName': 'Myat Thu', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Asami', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sato', 'Affiliation': 'Department of Implant Dentistry, School of Dentistry, Showa University, Tokyo, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Minakuchi', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}]",Journal of prosthodontic research,['10.1016/j.jpor.2019.03.002']
659,29265834,"Treatment agreement, adherence, and outcome in cognitive behavioral treatments for insomnia.","BACKGROUND


Patient adherence has been identified as an important barrier to the implementation of evidence-based psychological treatments.
OBJECTIVE


In cognitive behavioral treatments (CBT) for insomnia, the current study examined (a) the validity of therapist ratings of patient agreement and adherence against an established behavioral measure of adherence, and (b) the relationship between treatment agreement, adherence, and outcome.
METHOD


Participants were 188 adults meeting DSM-IV-TR criteria for chronic insomnia who were randomized to receive behavior therapy, cognitive therapy, or CBT for insomnia. Treatment agreement/adherence was measured by (a) weekly therapist ratings of patient agreement and homework completion, and (b) adherence to behavioral strategies (ABS) derived from patient-reported sleep diary. Outcome measures were Insomnia Severity Index and insomnia remission (Insomnia Severity Index <8).
RESULTS


Therapist ratings of patient agreement as well as homework completion were significantly associated with sleep diary-derived global ABS. Therapist-rated patient agreement and homework completion as well as global ABS predicted greater insomnia symptoms reduction from pretreatment to posttreatment. Patient agreement also predicted insomnia symptoms reduction from pretreatment to 6-month follow-up. Patient agreement, adherence, and ABS measures during treatment significantly predicted insomnia remission at posttreatment, and all but therapist rating of homework completion predicted remission at 6-month follow-up.
CONCLUSIONS


Greater patient agreement and adherence (therapist ratings and ABS) during treatment predicted better treatment outcome. Therapist-rated treatment agreement and adherence correspond well with patient-reported sleep diary-derived adherence measure. These simple, deployable therapist-rated patient agreement and adherence can potentially be useful for treatments for other disorders. (PsycINFO Database Record",2018,Therapist-rated patient agreement and homework completion as well as global ABS predicted greater insomnia symptoms reduction from pretreatment to posttreatment.,['Participants were 188 adults meeting DSM-IV-TR criteria for chronic insomnia who were randomized to receive'],"['behavior therapy, cognitive therapy, or CBT for insomnia', 'cognitive behavioral treatments (CBT']","['Insomnia Severity Index and insomnia remission (Insomnia Severity Index', 'insomnia remission', 'adherence (therapist ratings and ABS', 'insomnia symptoms reduction', 'homework completion', 'sleep diary-derived global ABS', 'adherence, and ABS measures', 'therapist ratings of patient agreement and homework completion, and (b) adherence to behavioral strategies (ABS']","[{'cui': 'C1506797', 'cui_str': 'AM 188'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0751249', 'cui_str': 'Chronic Insomnia'}]","[{'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0589414', 'cui_str': 'Homework, function (observable entity)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",188.0,0.0614186,Therapist-rated patient agreement and homework completion as well as global ABS predicted greater insomnia symptoms reduction from pretreatment to posttreatment.,"[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': 'Department of Psychology, University of California, Berkeley.'}, {'ForeName': 'Adriane M', 'Initials': 'AM', 'LastName': 'Soehner', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Bélanger', 'Affiliation': 'Department of Psychology, Université Laval.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Morin', 'Affiliation': 'Department of Psychology, Université Laval.'}, {'ForeName': 'Allison G', 'Initials': 'AG', 'LastName': 'Harvey', 'Affiliation': 'Department of Psychology, University of California, Berkeley.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000269']
660,30890382,"Intradermal post-exposure rabies vaccination with purified Vero cell rabies vaccine: Comparison of a one-week, 4-site regimen versus updated Thai Red Cross regimen in a randomized non-inferiority trial in the Philippines.","BACKGROUND


Rabies post-exposure prophylaxis (PEP) via intradermal (ID) administration is standard practice in Asia. Accumulating evidence suggests that PEP shortened to 3 visits in one week does not adversely affect seroconversion rates or immune memory.
OBJECTIVE


To determine whether the seroconversion rate at Day14 with a 1-week, 4-site (4-4-4-0-0) ID vaccination regimen with or without rabies immunoglobulin (RIG) was non-inferior to the updated Thai Red Cross (TRC) 28-day, 2-site (2-2-2-0-2) ID regimen with RIG during rabies PEP. We also assessed one-year antibody persistence.
METHODS


This phase III, mono-center, open-label, randomized-controlled trial assigned participants aged ≤50 years (n = 600) exposed to suspected rabid animals and sustaining WHO Category II injuries (automatic allocation to G1) or Category III injuries (randomized to G2 or G3) to the following groups (1:1:1 ratio): G1 (n = 200), 1-week 4-site ID regimen with the purified Vero cell rabies vaccine (PVRV; Verorab®) without RIG; G2 (n = 201), 1-week 4-site ID regimen with PVRV, and purified equine rabies immunoglobulin (pERIG); G3 (n = 199), TRC 28-day, 2-site ID regimen with PVRV, and pERIG. Non-inferiority tests compared G1 vs. G3 and G2 vs. G3. Seroconversion rate was the proportion (%) of vaccinees with rabies virus neutralizing antibodies (RVNA) titers ≥0.5 IU/mL measured by rapid fluorescent focus inhibition test.
RESULTS


On Day14, after the third vaccine administration, seroconversion rates were non-inferior in both comparisons and were, respectively, 100%, 99.4%, 98.8% in G1, G2, G3 with a decrease to 97.6%, 89%, 79.8% at Year 1. At Day14, RVNA geometric mean titers were 11.3 IU/mL; 9.89 IU/mL; 6.15 IU/mL, respectively, decreasing to 2.96 IU/mL, 1.37 IU/mL, 0.97 IU/mL at Year1. Safety and tolerability were similar between the three groups.
CONCLUSION


The seroconversion rate at Day 14 with the 1-week 4-site ID regimen, both with and without pERIG, was non-inferior to the reference TRC 28-day 2-site ID regimen with pERIG during rabies PEP with PVRV. ClinicalTrials.gov ID: NCT01622062.",2019,"Seroconversion rate was the proportion (%) of vaccinees with rabies virus neutralizing antibodies (RVNA) titers ≥0.5 IU/mL measured by rapid fluorescent focus inhibition test.
",['participants aged ≤50\u202fyears (n\u202f=\u202f600'],"['4-site regimen versus updated Thai Red Cross regimen', 'vaccination regimen with or without rabies immunoglobulin (RIG', 'Rabies post-exposure prophylaxis (PEP) via intradermal (ID) administration', 'suspected rabid animals and sustaining WHO Category II injuries (automatic allocation to G1) or Category III injuries (randomized to G2 or G3', 'purified Vero cell rabies vaccine (PVRV; Verorab®) without RIG; G2 (n\u202f=\u202f201), 1-week 4-site ID regimen with PVRV, and purified equine rabies immunoglobulin (pERIG); G3 (n\u202f=\u202f199), TRC 28-day, 2-site ID regimen with PVRV, and pERIG. Non-inferiority tests compared G1 vs. G3 and G2 vs. G3', 'Intradermal post-exposure rabies vaccination with purified Vero cell rabies vaccine']","['Safety and tolerability', 'seroconversion rate', 'seroconversion rates', 'seroconversion rates or immune memory', 'Seroconversion rate', 'RVNA geometric mean titers']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C0034907', 'cui_str': 'Red Crescent'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0301503', 'cui_str': 'rabies immune globulin, human'}, {'cui': 'C0034494', 'cui_str': 'Hydrophobia'}, {'cui': 'C1443861', 'cui_str': 'Post-Exposure Prevention'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0003062', 'cui_str': 'Animals'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0042542', 'cui_str': 'Vero Cells'}, {'cui': 'C0034496', 'cui_str': 'Rabies Vaccines'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0042205', 'cui_str': 'Rabies vaccination (procedure)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",,0.163362,"Seroconversion rate was the proportion (%) of vaccinees with rabies virus neutralizing antibodies (RVNA) titers ≥0.5 IU/mL measured by rapid fluorescent focus inhibition test.
","[{'ForeName': 'Beatriz P', 'Initials': 'BP', 'LastName': 'Quiambao', 'Affiliation': 'Research Institute for Tropical Medicine, Alabang, Muntinlupa City, Philippines.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Ambas', 'Affiliation': 'Research Institute for Tropical Medicine, Alabang, Muntinlupa City, Philippines.'}, {'ForeName': 'Sherylle', 'Initials': 'S', 'LastName': 'Diego', 'Affiliation': 'Research Institute for Tropical Medicine, Alabang, Muntinlupa City, Philippines.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Bosch Castells', 'Affiliation': 'Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Korejwo', 'Affiliation': 'Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Petit', 'Affiliation': 'Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Houillon', 'Affiliation': 'Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France. Electronic address: Guy.Houillon@sanofi.com.'}]",Vaccine,['10.1016/j.vaccine.2019.02.083']
661,30973315,Delay Discount Rate Moderates a Physical Activity Intervention Testing Immediate Rewards.,"Financial incentives can increase physical activity (PA), but differences in the immediacy of reward delivery and individual differences in delay discount rates (i.e., higher discount values associated with less tolerance for delayed rewards) may explain differential responding. The current study tested whether delay discount rate moderated the relative effectiveness of immediate financial rewards on increasing daily PA. Inactive, overweight adults (ages 18-60, N = 96) were randomized to receive either smaller, immediate goal-contingent rewards or larger, delayed rewards for participation. Delay discount rates were derived for those who completed the Monetary Choice Questionnaire (N = 85). Linear mixed models tested interactions between discount rate and intervention arm on changes in mean daily Fitbit-measured steps from baseline to intervention phases, and rates of change during the intervention phase. Across all groups, participants increased by 2258 steps/day on average from baseline to intervention and declined by 9 steps/day across the 4-month intervention phase. The mean increase in daily steps was greater for immediate reward-arm participants across all discount rates. Descriptive exploration of reward effects by delay discount rate suggested that the magnitude of reward effects decreased at higher discount rates. During the 4-month intervention phase, rates of decline in daily steps were similar in both reward arms, but declines became more pronounced at higher discount rates. Overall, intervention efficacy decreased with less tolerance for delays. The importance of financial reward immediacy for increasing PA appears to increase with greater delay discount rates.",2020,"During the 4-month intervention phase, rates of decline in daily steps were similar in both reward arms, but declines became more pronounced at higher discount rates.","['Inactive, overweight adults (ages 18-60, N\u2009=\u200996']","['smaller, immediate goal-contingent rewards or larger, delayed rewards for participation']","['rates of decline in daily steps', 'Delay discount rates', 'physical activity (PA', 'mean increase in daily steps']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C3850035', 'cui_str': 'Intertemporal Decision Making'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",,0.0534318,"During the 4-month intervention phase, rates of decline in daily steps were similar in both reward arms, but declines became more pronounced at higher discount rates.","[{'ForeName': 'Christine B', 'Initials': 'CB', 'LastName': 'Phillips', 'Affiliation': 'College of Health Solutions, Arizona State University.'}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Hurley', 'Affiliation': 'College of Health Solutions, Arizona State University.'}, {'ForeName': 'Siddhartha S', 'Initials': 'SS', 'LastName': 'Angadi', 'Affiliation': 'College of Health Solutions, Arizona State University.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Todd', 'Affiliation': 'College of Nursing and Health Innovation, Arizona State University.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Berardi', 'Affiliation': 'Crean College of Health and Behavioral Sciences, Chapman University.'}, {'ForeName': 'Melbourne F', 'Initials': 'MF', 'LastName': 'Hovell', 'Affiliation': 'Center for Behavioral Epidemiology and Community Health, San Diego State University.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Adams', 'Affiliation': 'College of Health Solutions, Arizona State University.'}]","Behavioral medicine (Washington, D.C.)",['10.1080/08964289.2019.1570071']
662,30888090,Blinding is compromised for transcranial direct current stimulation at 1 mA for 20 min in young healthy adults.,"Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation method that is frequently used to study cortical excitability changes and their impact on cognitive functions in humans. While most stimulators are capable of operating in double-blind mode, the amount of discomfort experienced during tDCS may break blinding. Therefore, specifically designed sham stimulation protocols are being used. The ""fade-in, short-stimulation, fade-out"" (FSF) protocol has been used in hundreds of studies and is commonly believed to be indistinguishable from real stimulation applied at 1 mA for 20 min. We analysed subjective reports of 192 volunteers, who either received real tDCS (n = 96) or FSF tDCS (n = 96). Participants reported more discomfort for real tDCS and correctly guessed the condition above chance-level. These findings indicate that FSF does not ensure complete blinding and that better active sham protocols are needed.",2019,Participants reported more discomfort for real tDCS and correctly guessed the condition above chance-level.,"['young healthy adults', '192 volunteers, who either received', 'humans']","['FSF', 'real tDCS', 'Transcranial direct current stimulation (tDCS', 'FSF tDCS']",['discomfort for real tDCS'],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]",192.0,0.0929626,Participants reported more discomfort for real tDCS and correctly guessed the condition above chance-level.,"[{'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Turi', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Csifcsák', 'Affiliation': 'Department of Psychology, University of Tromsø, Tromsø, Norway.'}, {'ForeName': 'Nya Mehnwolo', 'Initials': 'NM', 'LastName': 'Boayue', 'Affiliation': 'Department of Psychology, University of Tromsø, Tromsø, Norway.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Aslaksen', 'Affiliation': 'Department of Psychology, University of Tromsø, Tromsø, Norway.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Antal', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Paulus', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Groot', 'Affiliation': 'Department of Psychology, University of Tromsø, Tromsø, Norway.'}, {'ForeName': 'Guy E', 'Initials': 'GE', 'LastName': 'Hawkins', 'Affiliation': 'School of Psychology, University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Birte', 'Initials': 'B', 'LastName': 'Forstmann', 'Affiliation': 'Integrative Model-based Cognitive Neuroscience Research Unit, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Opitz', 'Affiliation': 'Department of Biomedical Engineering, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Thielscher', 'Affiliation': 'Department of Electrical Engineering, Technical University of Denmark, Lyngby, Denmark.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Mittner', 'Affiliation': 'Department of Psychology, University of Tromsø, Tromsø, Norway.'}]",The European journal of neuroscience,['10.1111/ejn.14403']
663,30865796,Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol.,"BACKGROUND


Short-term studies have shown that bempedoic acid, an inhibitor of ATP citrate lyase, reduces levels of low-density lipoprotein (LDL) cholesterol. Data are limited regarding the safety and efficacy of bempedoic acid treatment in long-term studies involving patients with hypercholesterolemia who are receiving guideline-recommended statin therapy.
METHODS


We conducted a randomized, controlled trial involving patients with atherosclerotic cardiovascular disease, heterozygous familial hypercholesterolemia, or both. Patients had to have an LDL cholesterol level of at least 70 mg per deciliter while they were receiving maximally tolerated statin therapy with or without additional lipid-lowering therapy. (Maximally tolerated statin therapy was defined as the highest intensity statin regimen that a patient was able to maintain, as determined by the investigator.) Patients were randomly assigned in a 2:1 ratio to receive bempedoic acid or placebo. The primary end point was safety, and the principal secondary end point (principal efficacy end point) was the percentage change in the LDL cholesterol level at week 12 of 52 weeks.
RESULTS


The trial involved 2230 patients, of whom 1488 were assigned to receive bempedoic acid and 742 to receive placebo. The mean (±SD) LDL cholesterol level at baseline was 103.2±29.4 mg per deciliter. The incidence of adverse events (1167 of 1487 patients [78.5%] in the bempedoic acid group and 584 of 742 [78.7%] in the placebo group) and serious adverse events (216 patients [14.5%] and 104 [14.0%], respectively) did not differ substantially between the two groups during the intervention period, but the incidence of adverse events leading to discontinuation of the regimen was higher in the bempedoic acid group than in the placebo group (162 patients [10.9%] vs. 53 [7.1%]), as was the incidence of gout (18 patients [1.2%] vs. 2 [0.3%]). At week 12, bempedoic acid reduced the mean LDL cholesterol level by 19.2 mg per deciliter, representing a change of -16.5% from baseline (difference vs. placebo in change from baseline, -18.1 percentage points; 95% confidence interval, -20.0 to -16.1; P<0.001). Safety and efficacy findings were consistent, regardless of the intensity of background statin therapy.
CONCLUSIONS


In this 52-week trial, bempedoic acid added to maximally tolerated statin therapy did not lead to a higher incidence of overall adverse events than placebo and led to significantly lower LDL cholesterol levels. (Funded by Esperion Therapeutics; CLEAR Harmony ClinicalTrials.gov number, NCT02666664.).",2019,"The incidence of adverse events (1167 of 1487 patients [78.5%] in the bempedoic acid group and 584 of 742 [78.7%] in the placebo group) and serious adverse events (216 patients [14.5%] and 104 [14.0%], respectively) did not differ substantially between the two groups during the intervention period, but the incidence of adverse events leading to discontinuation of the regimen was higher in the bempedoic acid group than in the placebo group (162 patients [10.9%] vs. 53 [7.1%]), as was the incidence of gout (18 patients [1.2%] vs. 2 [0.3%]).","['patients with hypercholesterolemia who are receiving guideline-recommended statin therapy', '2230 patients, of whom 1488 were assigned to receive', 'patients with atherosclerotic cardiovascular disease, heterozygous familial hypercholesterolemia, or both']","['Bempedoic Acid', 'bempedoic acid or placebo', 'placebo', 'bempedoic acid']","['mean LDL cholesterol level', 'incidence of adverse events leading to discontinuation', 'LDL Cholesterol', 'mean (±SD', 'overall adverse events', 'low-density lipoprotein (LDL) cholesterol', 'serious adverse events', 'incidence of adverse events', 'LDL cholesterol level', 'LDL cholesterol levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0342882', 'cui_str': 'Familial hypercholesterolemia - heterozygous (disorder)'}]","[{'cui': 'C3659310', 'cui_str': '8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",2230.0,0.469245,"The incidence of adverse events (1167 of 1487 patients [78.5%] in the bempedoic acid group and 584 of 742 [78.7%] in the placebo group) and serious adverse events (216 patients [14.5%] and 104 [14.0%], respectively) did not differ substantially between the two groups during the intervention period, but the incidence of adverse events leading to discontinuation of the regimen was higher in the bempedoic acid group than in the placebo group (162 patients [10.9%] vs. 53 [7.1%]), as was the incidence of gout (18 patients [1.2%] vs. 2 [0.3%]).","[{'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': 'From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY (H.E.B.); the University of Milan and Multimedica IRCCS, Milan (A.L.C.); Esperion Therapeutics, Ann Arbor, MI (N.D.L., L.T.B., L.R.S., P.L.R.); and Baylor College of Medicine, Houston (C.M.B.).'}, {'ForeName': 'Harold E', 'Initials': 'HE', 'LastName': 'Bays', 'Affiliation': 'From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY (H.E.B.); the University of Milan and Multimedica IRCCS, Milan (A.L.C.); Esperion Therapeutics, Ann Arbor, MI (N.D.L., L.T.B., L.R.S., P.L.R.); and Baylor College of Medicine, Houston (C.M.B.).'}, {'ForeName': 'Alberico L', 'Initials': 'AL', 'LastName': 'Catapano', 'Affiliation': 'From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY (H.E.B.); the University of Milan and Multimedica IRCCS, Milan (A.L.C.); Esperion Therapeutics, Ann Arbor, MI (N.D.L., L.T.B., L.R.S., P.L.R.); and Baylor College of Medicine, Houston (C.M.B.).'}, {'ForeName': 'Narendra D', 'Initials': 'ND', 'LastName': 'Lalwani', 'Affiliation': 'From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY (H.E.B.); the University of Milan and Multimedica IRCCS, Milan (A.L.C.); Esperion Therapeutics, Ann Arbor, MI (N.D.L., L.T.B., L.R.S., P.L.R.); and Baylor College of Medicine, Houston (C.M.B.).'}, {'ForeName': 'LeAnne T', 'Initials': 'LT', 'LastName': 'Bloedon', 'Affiliation': 'From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY (H.E.B.); the University of Milan and Multimedica IRCCS, Milan (A.L.C.); Esperion Therapeutics, Ann Arbor, MI (N.D.L., L.T.B., L.R.S., P.L.R.); and Baylor College of Medicine, Houston (C.M.B.).'}, {'ForeName': 'Lulu R', 'Initials': 'LR', 'LastName': 'Sterling', 'Affiliation': 'From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY (H.E.B.); the University of Milan and Multimedica IRCCS, Milan (A.L.C.); Esperion Therapeutics, Ann Arbor, MI (N.D.L., L.T.B., L.R.S., P.L.R.); and Baylor College of Medicine, Houston (C.M.B.).'}, {'ForeName': 'Paula L', 'Initials': 'PL', 'LastName': 'Robinson', 'Affiliation': 'From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY (H.E.B.); the University of Milan and Multimedica IRCCS, Milan (A.L.C.); Esperion Therapeutics, Ann Arbor, MI (N.D.L., L.T.B., L.R.S., P.L.R.); and Baylor College of Medicine, Houston (C.M.B.).'}, {'ForeName': 'Christie M', 'Initials': 'CM', 'LastName': 'Ballantyne', 'Affiliation': 'From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY (H.E.B.); the University of Milan and Multimedica IRCCS, Milan (A.L.C.); Esperion Therapeutics, Ann Arbor, MI (N.D.L., L.T.B., L.R.S., P.L.R.); and Baylor College of Medicine, Houston (C.M.B.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1803917']
664,30915778,"Effects of three treatment modalities (diet, myoinositol or myoinositol associated with D-chiro-inositol) on clinical and body composition outcomes in women with polycystic ovary syndrome.","OBJECTIVE


To evaluate, in overweight/obese PCOS women, which of three distinct treatment modalities achieved the greatest clinical benefits in terms of clinical and body composition outcomes.
PATIENTS AND METHODS


Forty-three polycystic ovary syndrome (PCOS) overweight/obese patients were randomly treated for 6 months with: only diet (Group 1, n = 21); diet and myo-inositol (MI) 4 g + folic acid 400 µg daily (group 2, n = 10); diet in association with MI 1.1 g + D-chiroinositol (DCI) 27.6 mg + folic acid 400 µg daily (group 3, n = 13). Menstrual cycle, Ferriman-Gallwey score, body mass index (BMI), waist circumference, hip circumference, waist-hip ratio (WHR), and body composition by bioimpedentiometry were measured at baseline, 3 and 6 months.
RESULTS


Body weight, BMI, waist and hip circumferences decreased significantly in all groups. There was a significant difference between the 3 groups regarding the restoration of menstrual regularity (p = 0.02) that was obtained in all patients only in-group 3.
CONCLUSIONS


MI+DCI in association with diet seems to accelerate the weight loss and the fat mass reduction with a slight increase of percent lean mass, and this treatment contributes significantly in restoring the regularity of the menstrual cycle.",2019,"There was a significant difference between the 3 groups regarding the restoration of menstrual regularity (p = 0.02) that was obtained in all patients only in-group 3.
","['Forty-three polycystic ovary syndrome (PCOS) overweight/obese patients', 'women with polycystic ovary syndrome', 'overweight/obese PCOS women']","['g + D-chiroinositol (DCI) 27.6 mg + folic acid', 'three treatment modalities (diet, myoinositol or myoinositol associated with D-chiro-inositol', 'diet and myo-inositol (MI) 4 g + folic acid 400 µg daily']","['restoration of menstrual regularity', 'weight loss', 'Body weight, BMI, waist and hip circumferences', 'Menstrual cycle, Ferriman-Gallwey score, body mass index (BMI), waist circumference, hip circumference, waist-hip ratio (WHR), and body composition by bioimpedentiometry']","[{'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0449581', 'cui_str': 'Regularity (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}, {'cui': 'C4553712', 'cui_str': 'Onset of menstrual cycle'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}]",43.0,0.0421363,"There was a significant difference between the 3 groups regarding the restoration of menstrual regularity (p = 0.02) that was obtained in all patients only in-group 3.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Le Donne', 'Affiliation': 'Department of Human Pathology in Adulthood and Childhood ""G. Barresi"", University of Messina, Messina, Italy. mledonne@unime.it.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Metro', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Alibrandi', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Papa', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Benvenga', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201903_17278']
665,30779861,Cost-Effectiveness of Osteoporosis Interventions to Improve Quality of Care After Upper Extremity Fracture: Results From a Randomized Trial (C-STOP Trial).,"We assessed the cost-effectiveness of two models of osteoporosis care after upper extremity fragility fracture using a high-intensity Fracture Liaison Service (FLS) Case-Manager intervention versus a low-intensity FLS (ie, Active Control), and both relative to usual care. This analysis used data from a pragmatic patient-level parallel-arm comparative effectiveness trial of 361 community-dwelling participants 50 years or older with upper extremity fractures undertaken at a Canadian academic hospital. We used a decision-analytic Markov model to evaluate the cost-effectiveness of the three treatment alternatives. The perspective was health service payer; the analytical horizon was lifetime; costs and health outcomes were discounted by 3%. Costs were expressed in 2016 Canadian dollars (CAD) and the health effect was measured by quality adjusted life years (QALYs). The average age of enrolled patients was 63 years and 89% were female. Per patient cost of the Case Manager and Active Control interventions were $66CAD and $18CAD, respectively. Compared to the Active Control, the Case Manager saved $333,000, gained seven QALYs, and averted nine additional fractures per 1000 patients. Compared to usual care, the Case Manager saved $564,000, gained 14 QALYs, and incurred 18 fewer fractures per 1000 patients, whereas the Active Control saved $231,000, gained seven QALYs, and incurred nine fewer fractures per 1000 patients. Although both interventions dominated usual care, the Case Manager intervention also dominated the Active Control. In 5000 probabilistic simulations, the probability that the Case Manager intervention was cost-effective was greater than 75% whereas the Active Control intervention was cost-effective in less than 20% of simulations. In summary, although the adoption of either of these approaches into clinical settings should lead to cost savings, reduced fractures, and increased quality-adjusted life for older adults following upper extremity fracture, the Case Manager intervention would be the most likely to be cost-effective. © 2019 American Society for Bone and Mineral Research.",2019,"Compared to usual care, the Case Manager saved $564,000, gained 14 QALYs, and incurred 18 fewer fractures per 1000 patients, whereas the Active Control saved $231,000, gained seven QALYs, and incurred nine fewer fractures per 1000 patients.","['older adults following upper extremity fracture', '© 2019 American Society for Bone and Mineral Research', 'average age of enrolled patients was 63 years and 89% were female', '361 community-dwelling participants 50 years or older with upper extremity fractures undertaken at a Canadian academic hospital', 'After Upper Extremity Fracture']","['high-intensity Fracture Liaison Service (FLS) Case-Manager intervention versus a low-intensity FLS (ie, Active Control', 'Osteoporosis Interventions']","['Quality of Care', 'cost-effective', 'cost-effectiveness']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0035168'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0687694', 'cui_str': 'Case Manager'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",361.0,0.0240633,"Compared to usual care, the Case Manager saved $564,000, gained 14 QALYs, and incurred 18 fewer fractures per 1000 patients, whereas the Active Control saved $231,000, gained seven QALYs, and incurred nine fewer fractures per 1000 patients.","[{'ForeName': 'Sumit R', 'Initials': 'SR', 'LastName': 'Majumdar', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Lier', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Finlay A', 'Initials': 'FA', 'LastName': 'McAlister', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Johnson', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Brian H', 'Initials': 'BH', 'LastName': 'Rowe', 'Affiliation': 'Department of Emergency Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Beaupre', 'Affiliation': 'Department of Physical Therapy, University of Alberta, Edmonton, AB, Canada.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3699']
666,30897297,Prophylactic onlay reinforcement with absorbable mesh (polyglactin) is associated with less early wound complications after kidney transplantation: A preliminary study.,"Incidence of wound complications after kidney transplantation (KTx) is still considerable. Here, we report the impact of prophylactic absorbable polyglactin (Vicryl®) mesh reinforcement on the incidence of short-term post-KTx wound complications. Sixty-nine patients were analyzed; 23 with and 46 without preventive onlay mesh reinforcement. Surgical site infections (SSI) were seen in six (26%) patients in the mesh group and in 17 (37%) patients in no-mesh group. A lower, but not statistically significant, rate of early postoperative wound complications occurred in the mesh group. Wound complications were observed in seven (30%) patients in the mesh group and in 23 (50%) patients in the no-mesh group. There was no association between mesh placement and SSI incidence (odds ratios [OR] 0.60, 95% confidence interval [CI] 0.20-1.82, p = 0.369) and wound complications (OR 0.44, 95% CI 0.15-1.26, p = 0.126). Therefore, we conclude that mesh reinforcement does not increase the risk of SSI and overall wound complications. Long-term outcomes have to be evaluated in a randomized trial setting. © 2019 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 108B:67-72, 2020.",2020,Wound complications were observed in seven (30%) patients in the mesh group and in 23 (50%) patients in the no-mesh group.,['Sixty-nine patients were analyzed; 23 with and 46 without preventive onlay mesh reinforcement'],"['prophylactic absorbable polyglactin (Vicryl®) mesh reinforcement', 'Prophylactic onlay reinforcement with absorbable mesh (polyglactin', 'kidney transplantation (KTx']","['wound complications', 'Wound complications', 'Incidence of wound complications', 'mesh placement and SSI incidence', 'Surgical site infections (SSI', 'rate of early postoperative wound complications', 'risk of SSI and overall wound complications']","[{'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0677511', 'cui_str': 'Onlay (qualifier value)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0032494', 'cui_str': 'Poly(Lactide-Co-Glycoside)'}, {'cui': 'C0947694', 'cui_str': 'Vicryl'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}, {'cui': 'C0677511', 'cui_str': 'Onlay (qualifier value)'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}]","[{'cui': 'C1096106'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0877305', 'cui_str': 'Postoperative wound complication'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",69.0,0.121241,Wound complications were observed in seven (30%) patients in the mesh group and in 23 (50%) patients in the no-mesh group.,"[{'ForeName': 'Christoph W', 'Initials': 'CW', 'LastName': 'Michalski', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mohammadi', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Khajeh', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Ghamarnejad', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Mohammadsadegh', 'Initials': 'M', 'LastName': 'Sabagh', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Pianka', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Golriz', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Yakup', 'Initials': 'Y', 'LastName': 'Kulu', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Kallinowski', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Zeier', 'Affiliation': 'Division of Nephrology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Morath', 'Affiliation': 'Division of Nephrology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus K', 'Initials': 'MK', 'LastName': 'Diener', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Büchler', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Arianeb', 'Initials': 'A', 'LastName': 'Mehrabi', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}]","Journal of biomedical materials research. Part B, Applied biomaterials",['10.1002/jbm.b.34366']
667,30829097,Effects of a social-media-based support on premenstrual syndrome and physical activity among female university students in South Korea.,"Introduction:  This study examined the effects of social-media-based support on premenstrual syndrome (PMS) and physical activity among female South Korean university students. Methods:  This quasi-experimental study with an equivalent-control-group pretest-posttest design randomly assigned 64 female students with PMS to the experimental or control group. The experimental group received social-media-based support through a smartphone application, text messaging, and e-mail for one menstrual cycle between September and December, 2016. Descriptive and inferential statistics included a Chi-square test and independent and paired  t -tests. Results:  Significant differences emerged between the experimental and control groups in total PMS scores ( p  = .003), 14 premenstrual symptoms, and physical activity ( p  = .010). Conclusions:  Female university students with PMS experienced decreased premenstrual symptoms and increased physical activity with social-media-based support, which could be an efficacious, accessible, and widely available nursing intervention to manage PMS and physical activity.",2020,"RESULTS


Significant differences emerged between the experimental and control groups in total PMS scores (p = .003), 14 premenstrual symptoms, and physical activity (p = .010).
","['64 female students with PMS to the experimental or control group', 'female university students in South Korea', 'female South Korean university students', 'Female university students with PMS']","['social-media-based support through a smartphone application, text messaging, and e-mail', 'social-media-based support']","['premenstrual syndrome (PMS) and physical activity', '14 premenstrual symptoms, and physical activity', 'premenstrual symptoms', 'total PMS scores', 'premenstrual syndrome and physical activity', 'physical activity']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0033046', 'cui_str': 'PMS - Premenstrual syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}]","[{'cui': 'C3179065', 'cui_str': 'Social Media'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0013849', 'cui_str': 'Email'}]","[{'cui': 'C0033046', 'cui_str': 'PMS - Premenstrual syndrome'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0232959', 'cui_str': 'Symptom occurs premenstrually (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",64.0,0.0146004,"RESULTS


Significant differences emerged between the experimental and control groups in total PMS scores (p = .003), 14 premenstrual symptoms, and physical activity (p = .010).
","[{'ForeName': 'Su Jin', 'Initials': 'SJ', 'LastName': 'Nam', 'Affiliation': 'School of Nursing, The University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Chiyoung', 'Initials': 'C', 'LastName': 'Cha', 'Affiliation': 'College of Nursing & Ewha Research Institute of Nursing Science, Ewha Womans University, Seodaemun-gu, Seoul, South Korea.'}]",Journal of psychosomatic obstetrics and gynaecology,['10.1080/0167482X.2018.1559811']
668,31828820,CO 2  Laser Cordectomy Versus KTP Laser Tumor Ablation for Early Glottic Cancer: A Randomized Controlled Trial.,"BACKGROUND AND OBJECTIVES


CO 2  laser cordectomy has been the workhorse of laser surgery for early glottic squamous cell carcinoma (GSCC) since the early 1970s. During the last decades, potassium titanyl phosphate (KTP) laser surgery for early GSCC gained popularity, introducing the tumor ablation technique. Yet, there are no previous randomized controlled trials (RCT) that compare the oncologic and functional outcomes of KTP Laser ablation versus CO 2  laser cordectomy for early GSCC. This study aims to compare by means of an RCT, CO 2  laser cordectomy with KTP laser ablation for early GSCC, in terms of cure rates and vocal function.
STUDY DESIGN/MATERIALS AND METHODS


A RCT conducted between 2013 and 2017. Patients with early GSCC were enrolled, and randomly assigned for either CO 2  cordectomy or KTP-ablation surgery with curative intent. All CO 2  cordectomies and most KTP-ablation procedures were performed under general anesthesia. Some KTP cases with residual disease were treated also under local anesthesia. Videostroboscopy measures, voice handicap index (VHI), GRBAS (a hoarseness scale for Grade, Roughness, Breathiness, Asthenia and Strain) score, and acoustic analyses were performed pre-operatively, 6 months and 3 years after surgery.
RESULTS


Twenty-four patients, 12 in each group, were enrolled. Nine in each group had T1a carcinoma, the remaining had either carcinoma in situ or T1b. The average number of procedures was 1.67( ± 0.89) and 1.33( ± 0.89) for the KTP and CO 2  groups, respectively. Although the tumor depth was comparable in both groups, patients in the KTP-ablation group underwent more superficial surgeries. Eleven (91.7%) procedures in the KTP group spared the vocal ligament, compared with 5 (41.7%) in the CO 2  group, (P = 0.023). All patients were alive and disease-free after four years. On post-operative videostroboscopy, normal mucosal waves appeared in 5 (42%) of the KTP patients versus none (0%) of the CO 2  (P = 0.02). The median post-operative non-vibrating portion was smaller in the KTP group (10%) compared with CO 2  (50%), P = 0.043. Nevertheless, GRBAS and VHI scores improved comparably in both groups.
CONCLUSIONS


KTP ablation technique offers similar curative outcome as CO 2  cordectomy but may allow for better preservation of vocal fold's architecture and function. Yet, the clinical significance of these findings is unclear, since the subjective measures improved comparably for these two treatment modalities. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc.",2020,"On post-operative videostroboscopy, normal mucosal waves appeared in 5 (42%) of the KTP patients versus none (0%) of the CO 2  (P = 0.02).","['2019', 'Patients with early GSCC', 'Twenty-four patients, 12 in each group, were enrolled', 'Early Glottic Cancer', 'Nine in each group had T1a carcinoma, the remaining had either carcinoma in situ or T1b', 'early glottic squamous cell carcinoma (GSCC) since the early 1970s']","['KTP-ablation', 'potassium titanyl phosphate (KTP) laser surgery', 'KTP Laser ablation', 'CO 2  Laser Cordectomy Versus KTP Laser Tumor Ablation', 'KTP ablation technique', 'KTP', 'CO 2  cordectomy or KTP-ablation surgery with curative intent', 'RCT, CO 2  laser cordectomy with KTP laser ablation']","['vocal ligament', 'GRBAS and VHI scores', 'Videostroboscopy measures, voice handicap index (VHI), GRBAS (a hoarseness scale for Grade, Roughness, Breathiness, Asthenia and Strain) score, and\xa0acoustic analyses', 'cure rates and vocal function', 'median post-operative non-vibrating portion', 'normal mucosal waves']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0007097', 'cui_str': 'Epithelioma'}, {'cui': 'C0007099', 'cui_str': 'Carcinoma, Intraepithelial'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0392222', 'cui_str': 'Potassium Titanyl Phosphate Lasers'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C2350239', 'cui_str': 'Ablation Techniques'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}]","[{'cui': 'C0225526', 'cui_str': 'Vocal Ligament'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index (assessment scale)'}, {'cui': 'C0019825', 'cui_str': 'Voice Hoarseness'}, {'cui': 'C0222045'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0559307', 'cui_str': 'Breathy voice quality (finding)'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1532868', 'cui_str': 'Vocal function'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}]",,0.0443583,"On post-operative videostroboscopy, normal mucosal waves appeared in 5 (42%) of the KTP patients versus none (0%) of the CO 2  (P = 0.02).","[{'ForeName': 'Yonatan', 'Initials': 'Y', 'LastName': 'Lahav', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Kaplan Medical Center, POB 1, Pasternak Rd, Rehovot, Israel.'}, {'ForeName': 'Oded', 'Initials': 'O', 'LastName': 'Cohen', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Kaplan Medical Center, POB 1, Pasternak Rd, Rehovot, Israel.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Shapira-Galitz', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Kaplan Medical Center, POB 1, Pasternak Rd, Rehovot, Israel.'}, {'ForeName': 'Doron', 'Initials': 'D', 'LastName': 'Halperin', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Kaplan Medical Center, POB 1, Pasternak Rd, Rehovot, Israel.'}, {'ForeName': 'Hagit', 'Initials': 'H', 'LastName': 'Shoffel-Havakuk', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery, Rabin Medical Center, 39 Ze'ev Jabotinski St, Petach-Tikva, 4941492, Israel.""}]",Lasers in surgery and medicine,['10.1002/lsm.23202']
669,30882914,Pharmacokinetics of Ursodeoxycholic Acid in Elderly Volunteers Compared With Younger Adults in a Korean Population.,"Ursodeoxycholic acid (UDCA) is a secondary bile acid component used for treating primary biliary cirrhosis. This study evaluated and compared the pharmacokinetic (PK) profiles of UDCA and its conjugates glyco-UDCA (G-UDCA) and tauro-UDCA (T-UDCA) in healthy elderly subjects and younger adults. In this randomized, open-label, 2-treatment, 1-sequence, and parallel study, subjects received 400 or 800 mg UDCA on day 1, followed by 200 mg UDCA twice daily for 2 weeks. Blood samples were obtained up to 24 hours after the first UDCA dose. Changes in miRNA-122, γ-glutamyl transferase, aspartate aminotransferase, and alanine aminotransferase levels from baseline were assessed to determine the safety and pharmacological effects of UDCA. This study examined the outcomes of 16 elderly subjects and 16 younger adults. Dose-normalized peak concentration of and systemic exposure to UDCA were 2 to 4 times higher, and the corresponding values of G-UDCA and T-UDCA were 1.7 times higher in the elderly subjects than in the younger adults. The subjects in both groups showed multiple peak profiles of UDCA and its conjugates. The miRNA-122 levels and hepatic enzyme test results were within the normal range in the elderly subjects after multiple administration of UDCA. This study is the first to confirm that the PK measurements of UDCA were higher in elderly subjects than in younger adults, which may improve the clinical outcomes of elderly subjects.",2019,The miRNA-122 levels and hepatic enzyme test results were within the normal range in the elderly subjects after multiple administration of UDCA.,"['elderly subjects', '16 elderly subjects and 16 younger adults', 'elderly subjects than in younger adults', 'Elderly Volunteers Compared With Younger Adults in a Korean Population', 'healthy elderly subjects and younger adults']","['Ursodeoxycholic acid (UDCA', 'UDCA and its conjugates glyco-UDCA (G-UDCA) and tauro-UDCA (T-UDCA', 'UDCA', 'Ursodeoxycholic Acid']","['Blood samples', 'Changes in miRNA-122, γ-glutamyl transferase, aspartate aminotransferase, and alanine aminotransferase levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0042105', 'cui_str': 'ursodesoxycholic acid'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1101610', 'cui_str': 'miRNA'}, {'cui': 'C0678107', 'cui_str': 'Glutamyl transferase (substance)'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",16.0,0.0143199,The miRNA-122 levels and hepatic enzyme test results were within the normal range in the elderly subjects after multiple administration of UDCA.,"[{'ForeName': 'Soyoung', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Seonghae', 'Initials': 'S', 'LastName': 'Yoon', 'Affiliation': 'Clinical Trials Center, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Hyewon', 'Initials': 'H', 'LastName': 'Chung', 'Affiliation': 'Department of Clinical Pharmacology and Toxicology, Korea University Guro Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Sang Chun', 'Initials': 'SC', 'LastName': 'Ji', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Seo Hyun', 'Initials': 'SH', 'LastName': 'Yoon', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Kyung-Sang', 'Initials': 'KS', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Joo-Youn', 'Initials': 'JY', 'LastName': 'Cho', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Yong', 'Initials': 'JY', 'LastName': 'Chung', 'Affiliation': 'Clinical Trials Center, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}]",Journal of clinical pharmacology,['10.1002/jcph.1409']
670,31706658,Comparison of high-flow nasal cannula oxygen therapy and conventional reserve-bag oxygen therapy in carbon monoxide intoxication: A pilot study.,"BACKGROUND


High-flow nasal cannula oxygen (HFNC) creates a positive pressure effect through high-flow rates compared to conventional oxygen therapy. The purpose of this human pilot study is to compare the effects of HFNC and conventional oxygen therapy on the rate of carbon monoxide (CO) clearance from the blood in patients with mild to moderate CO poisoning.
METHODS


CO-poisoned Patients randomly received 100% oxygen from a rebreathing reserve mask (NBO 2 , flow of 15 L/min) or HFNC (flow of 60 L/min). The fraction of COHb value (fCOHb) was measured in 30-min intervals until it fell to under 10%. We determined the Half-life time of fCOHb (fCOHb t 1/2 ).
RESULTS


A total of 22 patients had fCOHb levels ≥ 10% at the time of ED arrival, with 9 of them having fCOHb level ranging between 25% and 50%. There was no significant difference in the fCOHbt 1/2  between the HFNC group and NBO 2  group. However, the mean fCOHbt 1/2  in the HFNC group (48.5 ± 12.4 min) has a smaller standard deviation than that in the NBO 2  group (99.3 ± 93.38 min). There were significant between-group differences in the mean COHbt 1/2  among the patients with fCOHb levels less than 25% (HFNC 43.6 ± 10.6 vs. NBO 2  134.2 ± 111.3).
CONCLUSIONS


In this pilot randomized controlled trial study, HFNC therapy did not reduce fCOHbt 1/2  compared to NBO 2  therapy but could be beneficial in maintaining a constant fCOHbt 1/2  as well as in reducing fCOHbt 1/2  in mild CO poisoning patients compared to conventional NBO 2  therapy. However, further studies with a larger number of patients are needed to establish HFNC therapy as an alternative therapy for CO poisoning patients.",2020,There was no significant difference in the fCOHbt 1/2  between the HFNC group and NBO 2  group.,"['CO poisoning patients', 'patients with mild to moderate CO poisoning', 'mild CO poisoning patients', 'carbon monoxide intoxication', 'CO-poisoned Patients randomly received']","['HFNC therapy', 'HFNC', 'high-flow nasal cannula oxygen therapy and conventional reserve-bag oxygen therapy', 'HFNC and conventional oxygen therapy', '100% oxygen from a rebreathing reserve mask (NBO 2 , flow of 15\u202fL/min) or HFNC', 'High-flow nasal cannula oxygen (HFNC']","['fraction of COHb value (fCOHb', 'rate of carbon monoxide (CO) clearance']","[{'cui': 'C0032343', 'cui_str': 'Poisoning'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0728899', 'cui_str': 'Intoxication'}, {'cui': 'C0032344', 'cui_str': 'poisoning'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1706249', 'cui_str': 'Bag - unit of product usage (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0439393', 'cui_str': 'liter/minute'}]","[{'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}]",,0.0854453,There was no significant difference in the fCOHbt 1/2  between the HFNC group and NBO 2  group.,"[{'ForeName': 'Young-Min', 'Initials': 'YM', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Chungbuk National University Hospital, 776, Sunhwan-ro, Seowon-gu, Cheongju, Republic of Korea.'}, {'ForeName': 'Hyun-Jo', 'Initials': 'HJ', 'LastName': 'Shin', 'Affiliation': 'Department of Emergency Medicine, Chungbuk National University Hospital, 776, Sunhwan-ro, Seowon-gu, Cheongju, Republic of Korea.'}, {'ForeName': 'Dong-Won', 'Initials': 'DW', 'LastName': 'Choi', 'Affiliation': 'Department of Emergency Medicine, Chungbuk National University Hospital, 776, Sunhwan-ro, Seowon-gu, Cheongju, Republic of Korea.'}, {'ForeName': 'Ji-Min', 'Initials': 'JM', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Chungbuk National University Hospital, 776, Sunhwan-ro, Seowon-gu, Cheongju, Republic of Korea.'}, {'ForeName': 'Suk-Woo', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, Chungbuk National University Hospital, 776, Sunhwan-ro, Seowon-gu, Cheongju, Republic of Korea; Department of Emergency Medicine, College of Medicine, Chungbuk National University, 1, Chungdae-ro, Seowon-gu, Cheongju, Republic of Korea.'}, {'ForeName': 'Seong-Hae', 'Initials': 'SH', 'LastName': 'Jeong', 'Affiliation': 'Department of Neurology, Chungnam National University Hospital, 282, Munhwa-ro, Jung-gu, Daejeon, Republic of Korea; Department of Neurology, Chungnam National University, School of Medicine, 282, Munhwa-ro, Jung-gu, Daejeon, Republic of Korea.'}, {'ForeName': 'Hoon', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Chungbuk National University Hospital, 776, Sunhwan-ro, Seowon-gu, Cheongju, Republic of Korea; Department of Emergency Medicine, College of Medicine, Chungbuk National University, 1, Chungdae-ro, Seowon-gu, Cheongju, Republic of Korea. Electronic address: nichekh2000@chungbuk.ac.kr.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.158451']
671,30885021,Lumbopelvic Fixation Versus Novel Adjustable Plate for Sacral Fractures: A Retrospective Comparative Study.,"Purpose:  The purpose of this study is to compare the therapeutic effects of the lumbopelvic technique and a novel adjustable plate for sacral fractures.  Materials and Methods:  Patients with unilateral sacral fractures fixed via the lumbopelvic technique or using a novel adjustable plate from June 2011 to June 2017 were recruited into this study and were divided into two groups: group A (lumbopelvic fixation) and group B (novel adjustable plate). Surgical time, intraoperative blood loss, frequency of intraoperative fluoroscopy, reduction quality, and related complications were reviewed. Fracture healing was assessed by the radiographs conducted at follow-up. Functional outcome was evaluated according to the Majeed score at the final follow-up.  Results:  The mean blood loss and frequency of intraoperative fluoroscopy in group B were reduced compared with group A (both  P  < 0.001). The mean surgical time was 122.22 ± 13.09 minutes in group A and 103.96 ± 24.80 minutes in group B ( P  = 0.007). All patients healed well in this study, and no difference in the fracture healing time was noted between the two groups ( P  = 0.685). Satisfactory rates of reduction quality and functional outcome did not differ (both  P  > 0.05) in this study. The complication rate was 22.22% (4/18) in group A and 4.16% (1/24) in group B ( P  = 0.191).  Conclusion:  For patients with unilateral sacral fractures, satisfactory radiographic appearance and functional outcome could be obtained by both the lumbopelvic technique and a novel adjustable plate. However, the novel adjustable plate represents a less invasive technique with lower radiograph exposure.",2020,"All patients healed well in this study, and no difference in the fracture healing time was noted between the two groups (P = 0.685).","['patients with unilateral sacral fractures', 'Sacral Fractures', 'Patients with unilateral sacral fractures fixed via the lumbopelvic technique or using a novel adjustable plate from June 2011 to June 2017']","['group A (lumbopelvic fixation) and group B (novel adjustable plate', 'Lumbopelvic Fixation Versus Novel Adjustable Plate', 'lumbopelvic technique and a novel adjustable plate']","['Satisfactory rates of reduction quality and functional outcome', 'mean surgical time', 'fracture healing time', 'Surgical time, intraoperative blood loss, frequency of intraoperative fluoroscopy, reduction quality, and related complications', 'satisfactory radiographic appearance and functional outcome', 'Fracture healing', 'complication rate', 'mean blood loss and frequency of intraoperative fluoroscopy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}]","[{'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0162542', 'cui_str': 'Fracture Healing'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}]",,0.015132,"All patients healed well in this study, and no difference in the fracture healing time was noted between the two groups (P = 0.685).","[{'ForeName': 'Ruipeng', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedic Surgery, Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Yingchao', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'Department of Orthopaedic Surgery, Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Shilun', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedic Surgery, Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Ao', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedic Surgery, Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Hou', 'Affiliation': 'Department of Orthopaedic Surgery, Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Yingze', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedic Surgery, Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}]",Journal of investigative surgery : the official journal of the Academy of Surgical Research,['10.1080/08941939.2019.1569737']
672,30877596,Feasibility of a mindful yoga program for women with metastatic breast cancer: results of a randomized pilot study.,"PURPOSE


Patients with metastatic breast cancer (MBC) experience high levels of symptoms. Yoga interventions have shown promise for improving cancer symptoms but have rarely been tested in patients with advanced disease. This study examined the acceptability of a comprehensive yoga program for MBC and the feasibility of conducting a randomized trial testing the intervention.
METHODS


Sixty-three women with MBC were randomized with a 2:1 allocation to yoga or a support group comparison condition. Both interventions involved eight weekly group sessions. Feasibility was quantified using rates of accrual, attrition, and session attendance. Acceptability was assessed with a standardized self-report measure. Pain, fatigue, sleep quality, psychological distress, mindfulness, and functional capacity were assessed at baseline, post-intervention, and 3 and 6 months post-intervention.
RESULTS


We met goals for accrual and retention, with 50% of eligible patients enrolled and 87% of randomized participants completing post-intervention surveys. Sixty-five percent of women in the yoga condition and 90% in the support group attended ≥ 4 sessions. Eighty percent of participants in the yoga condition and 65% in the support group indicated that they were highly satisfied with the intervention. Following treatment, women in the yoga intervention had modest improvements in some outcomes; however, overall symptom levels were low for women in both conditions.
CONCLUSIONS


Findings suggest that the yoga intervention content was highly acceptable to patients with MBC, but that there are challenges to implementing an intervention involving eight group-based in-person sessions. Alternative modes of delivery may be necessary to reach patients most in need of intervention.",2019,"Following treatment, women in the yoga intervention had modest improvements in some outcomes; however, overall symptom levels were low for women in both conditions.
","['patients with advanced disease', 'Sixty-three women with MBC', 'Patients with metastatic breast cancer (MBC) experience high levels of symptoms', 'women with metastatic breast cancer']","['Yoga interventions', 'comprehensive yoga program', 'mindful yoga program']","['cancer symptoms', 'Acceptability', 'overall symptom levels', 'rates of accrual, attrition, and session attendance', 'Pain, fatigue, sleep quality, psychological distress, mindfulness, and functional capacity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}]",63.0,0.0666235,"Following treatment, women in the yoga intervention had modest improvements in some outcomes; however, overall symptom levels were low for women in both conditions.
","[{'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Porter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Box 90399, Durham, NC, 27708, USA. laura.porter@duke.edu.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Carson', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd., Portland, OR, 97239, USA.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Olsen', 'Affiliation': 'Center for Health Services Research in Primary Care, Durham VA Medical Center, Durham, NC, 27705, USA.'}, {'ForeName': 'Kimberly M', 'Initials': 'KM', 'LastName': 'Carson', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd., Portland, OR, 97239, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Sanders', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Box 2628, Durham, NC, 27710, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Jones', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, 1250 First Avenue, New York, NY, 10065, and Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Westbrook', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Box 3459, Durham, NC, 27710, USA.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Keefe', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Box 90399, Durham, NC, 27708, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-04710-7']
673,31693994,A Controlled Evaluation of a CBPR Intervention's Effects on Physical Activity and the Related Psychosocial Constructs Among Minority Children in an Underserved Community.,"BACKGROUND


Effective physical activity interventions are needed for children because health behaviors track into adulthood, and risk factors for diseases begin early in life. No study has determined whether an intervention designed using a Community-Based Participatory Research approach can improve moderate to vigorous physical activity (MVPA) and the related psychosocial constructs in underserved children. This study determined whether improvements in MVPA and related psychosocial constructs (self-efficacy, knowledge, beliefs, attitudes, and skills) occurred following a Community-Based Participatory Research intervention in underserved, rural children. It was then determined if these constructs were mediators of MVPA.
METHODS


Two fifth-grade classes at a school (n = 19 and n = 20) were randomly assigned to an intervention or comparison group. The intervention group participated in a 4-week intervention designed to improve MVPA (wGT3X-BT accelerometer; ActiGraph, Pensacola, FL) and the related psychosocial constructs (written survey). Groups were assessed prior to and immediately following the intervention.
RESULTS


There were no differences at baseline between groups. MVPA (30.0 [4.4] min), knowledge, and skill scores were significantly higher in the intervention group compared with the comparison group at follow-up (P < .05). Knowledge and skills were mediating variables of MVPA.
CONCLUSIONS


Priority should be placed on research that determines the sustained impact of similar Community-Based Participatory Research interventions.",2020,"MVPA (30.0 [4.4] min), knowledge, and skill scores were significantly higher in the intervention group compared with the comparison group at follow-up (P < .05).","['Minority Children in an Underserved Community', 'underserved, rural children', 'underserved children', 'Two fifth-grade classes at a school (n = 19 and n = 20']","['4-week intervention designed to improve MVPA (wGT3X-BT accelerometer; ActiGraph, Pensacola, FL) and the related psychosocial constructs (written survey', 'Community-Based Participatory Research intervention', ""CBPR Intervention's""]","['knowledge, and skill scores', 'MVPA', 'MVPA and related psychosocial constructs (self-efficacy, knowledge, beliefs, attitudes, and skills', 'Physical Activity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C2350575', 'cui_str': 'Community-Based Participatory Research'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0256111,"MVPA (30.0 [4.4] min), knowledge, and skill scores were significantly higher in the intervention group compared with the comparison group at follow-up (P < .05).","[{'ForeName': 'Kara C', 'Initials': 'KC', 'LastName': 'Hamilton', 'Affiliation': ''}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Richardson', 'Affiliation': ''}, {'ForeName': 'Shanda', 'Initials': 'S', 'LastName': 'McGraw', 'Affiliation': ''}, {'ForeName': 'Teirdre', 'Initials': 'T', 'LastName': 'Owens', 'Affiliation': ''}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Higginbotham', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0135']
674,29521723,Large Balloon Dilatation Versus Mechanical Lithotripsy After Endoscopic Sphincterotomy in the Management of Large Common Bile Duct Stones in Cirrhotic Patients: A Randomized Study.,"BACKGROUND AND STUDY AIM


Removal of large common bile duct (CBD) stones is one of the challenges faced during endoscopic retrograde cholangiopancreatography, and it seems more difficult in cirrhotic patients because of suspected higher rates of adverse events, especially bleeding diathesis. This study aimed at comparing the success rate and complications between mechanical lithotripsy (ML) and large balloon dilation (LBD) after endoscopic sphincterotomy in patients with liver cirrhosis.
PATIENTS AND METHODS


Ninety-eight cirrhotic patients with calcular obstructive jaundice were included and randomly divided into 2 groups: group A comprising 49 patients treated by LBD and group B comprising 49 patients treated by ML. All patients underwent sphincterotomy initially. All patients were subjected to thorough history taking and complete clinical examination. Pancreatic enzyme concentrations were measured 4 hours before and 24 hours after the procedure, and complete blood cell count and liver function tests were performed before and the morning after the procedure. Before and during endoscopic retrograde cholangiopancreatography, stone size and number were verified.
RESULTS


The success rate for CBD clearance was 98% and 93.8% for LBD and ML, respectively. The rate of adverse events in this study was 10.2% (10/98), and bleeding was the commonest reported complication (5/10). Group B developed more (16.3%) adverse events than group A (4.1%), and the difference was statistically significant (P=0.04).
CONCLUSION


Endoscopic sphincterotomy followed by LBD is a safe and effective treatment for large CBD stones in cirrhotic patients in comparison with sphincterotomy followed by ML.",2019,"Group B developed more (16.3%) adverse events than group A (4.1%), and the difference was statistically significant (P=0.04).
","['Cirrhotic Patients', 'patients with liver cirrhosis', 'Ninety-eight cirrhotic patients with calcular obstructive jaundice', 'cirrhotic patients']","['Endoscopic sphincterotomy followed by LBD', 'mechanical lithotripsy (ML) and large balloon dilation (LBD', 'Endoscopic Sphincterotomy', 'LBD and group B comprising 49 patients treated by ML', 'Large Balloon Dilatation Versus Mechanical Lithotripsy', 'endoscopic sphincterotomy']","['Pancreatic enzyme concentrations', 'bleeding', 'adverse events', 'complete blood cell count and liver function tests', 'rate of adverse events', 'success rate for CBD clearance']","[{'cui': 'C0439686', 'cui_str': 'Cirrhotic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023890', 'cui_str': 'Hepatic Cirrhosis'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C0022354', 'cui_str': 'Jaundice, Obstructive'}]","[{'cui': 'C0085263', 'cui_str': 'Endoscopic Biliary Sphincterotomy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0920330', 'cui_str': 'Product containing pancreatic enzyme (product)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0005771', 'cui_str': 'Blood Cell Number'}, {'cui': 'C0023901', 'cui_str': 'Liver Function Tests'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}]",98.0,0.0417099,"Group B developed more (16.3%) adverse events than group A (4.1%), and the difference was statistically significant (P=0.04).
","[{'ForeName': 'Mohamed I', 'Initials': 'MI', 'LastName': 'Radwan', 'Affiliation': 'Tropical Medicine Department, Faculty of Medicine, Zagazig University.'}, {'ForeName': 'Mohamed H', 'Initials': 'MH', 'LastName': 'Emara', 'Affiliation': 'Tropical Medicine Department, Faculty of Medicine, Zagazig University.'}, {'ForeName': 'Ibrahim M', 'Initials': 'IM', 'LastName': 'Ibrahim', 'Affiliation': 'Tropical Medicine Department, Faculty of Medicine, Zagazig University.'}, {'ForeName': 'Mahmoud E', 'Initials': 'ME', 'LastName': 'Moursy', 'Affiliation': 'Gastroenterology Department, Al-Ahrar Teaching Hospital, Zagazig.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001000']
675,30808245,Is There a Spillover Effect of Targeted Dietary Change on Untargeted Health Behaviors? Evidence From a Dietary Modification Trial.,"Background . The gateway behavior hypothesis posits that change in a health behavior targeted for modification may promote positive changes in other untargeted health behaviors; however, previous studies have shown inconsistent results.  Aims . To examine the patterns and predictors of change in untargeted health behaviors in a large health behavior change trial.  Method . Using repeated-measures latent class analysis, this study explored patterns of change in untargeted physical activity, alcohol consumption, and smoking behavior during the first year of the Women's Health Initiative dietary modification trial that targeted total fat reduction to 20% kcal and targeted increased fruit and vegetable intake. Participants were healthy postmenopausal women who were randomly assigned to either the low-fat dietary change intervention ( n  = 8,193) or a control ( n  = 12,187) arm.  Results . Although there were increases in untargeted physical activity and decreases in alcohol consumption and smoking in the first year, these changes were not consistently associated with study arm. Moreover, although the results of the repeated-measures latent class analysis identified three unique subgroups of participants with similar patterns of untargeted health behaviors, none of the subgroups showed substantial change in the probability of engagement in any of the behaviors over 1 year, and the study arms had nearly identical latent class solutions.  Discussion and Conclusion . These findings suggest that the dietary intervention did not act as a gateway behavior for change in the untargeted behaviors and that researchers interested in changing multiple health behaviors may need to deliberately target additional behaviors.",2019,"Although there were increases in untargeted physical activity and decreases in alcohol consumption and smoking in the first year, these changes were not consistently associated with study arm.",['Participants were healthy postmenopausal women'],['low-fat dietary change intervention'],"['untargeted physical activity', 'alcohol consumption and smoking', 'untargeted physical activity, alcohol consumption, and smoking behavior']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C1519383', 'cui_str': 'Smoking Behaviors'}]",,0.0606933,"Although there were increases in untargeted physical activity and decreases in alcohol consumption and smoking in the first year, these changes were not consistently associated with study arm.","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Sarma', 'Affiliation': '1 Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Moyer', 'Affiliation': '1 Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Catherine R', 'Initials': 'CR', 'LastName': 'Messina', 'Affiliation': '1 Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Helena H', 'Initials': 'HH', 'LastName': 'Laroche', 'Affiliation': '2 University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Snetselaar', 'Affiliation': '2 University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Van Horn', 'Affiliation': '3 Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Dorothy S', 'Initials': 'DS', 'LastName': 'Lane', 'Affiliation': '1 Stony Brook University, Stony Brook, NY, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198119831756']
676,30808316,The effect of diluting povidone-iodine on bacterial growth associated with speech.,"BACKGROUND


Povidone-Iodine (PI) may be diluted when used as an antiseptic prior to an intravitreal injection in an attempt to decrease patient discomfort. This study aims to investigate the effect of diluting povidone-iodine (PI) on bacterial growth from bacterial droplet dispersal associated with speech.
METHODS


Participants read a standardised script for 5 min over a blood agar plate positioned at 20 cm in a simulated position of an intravitreal injection procedure. The blood agar plates were subject to a randomised pre-application of 1% PI; 2.5% PI; 5% PI and no pre-application (control). The plates were incubated at 37 °C for 72 h and the number of Colony Forming Units (CFUs) was determined. CFUs were summarised as median and interquartile range (IQR). Wilcoxon rank sum test was used to assess pairwise comparisons of the various PI concentrations to the control group. Any trend across PI concentration was assessed using Kendall's tau rank correlation.
RESULTS


Twenty-one subjects participated. Control plates had a median growth of 25 CFUs (interquartile range [IQR]:15-40), 1% PI plates had a median growth of 30 CFUs (IQR:15-82), 2.5% PI had a median growth of 18 CFUs (IQR:10-32) and 5% PI had a median growth of 2 CFUs (IQR:0-5). There was significantly less bacterial growth with 5% PI compared to control (P < 0.001). Bacterial growth at 2.5% PI and 1% PI did not differ significantly from control. There was a statistically significant trend for decreasing colony count as PI concentration increased (P < 0.001).
CONCLUSIONS


PI concentrations less than 5% are not effective at reducing bacterial growth from bacterial droplet dispersal associated with speech. When using PI for pre-injection antisepsis, concentrations below 5% should be avoided.",2019,There was significantly less bacterial growth with 5% PI compared to control (P < 0.001).,"['Twenty-one subjects participated', 'Participants read a']","['diluting povidone-iodine', 'Povidone-Iodine (PI', 'diluting povidone-iodine (PI', 'standardised script for 5\u2009min over a blood agar plate positioned at 20\u2009cm in a simulated position of an intravitreal injection procedure']","['bacterial growth', 'Bacterial growth', 'median growth of 18 CFUs', 'PI concentration', 'median growth of 2 CFUs', 'median growth of 25 CFUs', 'median growth of 30 CFUs', 'decreasing colony count as PI concentration']","[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]","[{'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C3266603', 'cui_str': 'Blood agar'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0427944', 'cui_str': 'Finding of growth of bacteria'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0368993', 'cui_str': 'Colony count'}]",21.0,0.022998,There was significantly less bacterial growth with 5% PI compared to control (P < 0.001).,"[{'ForeName': 'Sivashanth', 'Initials': 'S', 'LastName': 'Gnanasekaran', 'Affiliation': 'Centre For Eye Research Australia, The Royal Victorian Eye and Ear Hospital, University of Melbourne, 32 Gisborne Street, East Melbourne, Victoria, 3002, Australia. Sivashanth.Gnanasekaran@wh.org.au.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Rogers', 'Affiliation': 'Centre For Eye Research Australia, The Royal Victorian Eye and Ear Hospital, University of Melbourne, 32 Gisborne Street, East Melbourne, Victoria, 3002, Australia.'}, {'ForeName': 'Sanj', 'Initials': 'S', 'LastName': 'Wickremasinghe', 'Affiliation': 'Centre For Eye Research Australia, The Royal Victorian Eye and Ear Hospital, University of Melbourne, 32 Gisborne Street, East Melbourne, Victoria, 3002, Australia.'}, {'ForeName': 'Sukhpal S', 'Initials': 'SS', 'LastName': 'Sandhu', 'Affiliation': 'Centre For Eye Research Australia, The Royal Victorian Eye and Ear Hospital, University of Melbourne, 32 Gisborne Street, East Melbourne, Victoria, 3002, Australia.'}]",BMC ophthalmology,['10.1186/s12886-019-1066-5']
677,30745147,Impact of a quadrivalent inactivated influenza vaccine on influenza-associated complications and health care use in children aged 6 to 35 months: Analysis of data from a phase III trial in the Northern and Southern Hemispheres.,"BACKGROUND


A multi-season phase III trial conducted in the Northern and Southern Hemispheres demonstrated the efficacy of a quadrivalent split-virion inactivated influenza vaccine (IIV4) in children 6-35 months of age.
METHODS


Data collected during the phase III trial were analysed to examine the vaccine efficacy (VE) of IIV4 in preventing laboratory-confirmed influenza in age subgroups and to determine the relative risk for IIV4 vs. placebo for severe outcomes, healthcare use, and parental absenteeism from work associated with laboratory-confirmed influenza.
RESULTS


VE (95% confidence interval [CI]) to prevent laboratory-confirmed influenza due to any A or B strain was 54.76% (40.24-66.03%) for participants aged 6-23 months and 46.91% (23.57-63.53%) for participants aged 24-35 months. VE (95% CI) to prevent laboratory-confirmed influenza due to vaccine-similar strains was 74.51% (53.55-86.91%) for participants aged 6-23 months and 59.78% (19.11-81.25%) for participants aged 24-35 months. Compared to placebo, IIV4 reduced the risk (95% CI) by 31.28% (8.96-89.34%) for acute otitis media, 21.76% (6.46-58.51%) for acute lower respiratory infection, 40.80% (29.62-55.59%) for healthcare medical visits, 29.71% (11.66-67.23%) for parent absenteeism from work, and 39.20% (26.89-56.24%) for antibiotic use.
CONCLUSION


In children aged 6-35 months, vaccination with IIV4 reduces severe outcomes of influenza as well as the associated burden for their parents and the healthcare system. In addition, vaccination with IIV4 is effective at preventing against influenza in children aged 6-23 and 24-35 months.
TRIAL REGISTRATION


EudraCT no. 2013-001231-51.",2019,"Compared to placebo, IIV4 reduced the risk (95% CI) by 31.28% (8.96-89.34%) for acute otitis media, 21.76% (6.46-58.51%) for acute lower respiratory infection, 40.80% (29.62-55.59%) for healthcare medical visits, 29.71% (11.66-67.23%) for parent absenteeism from work, and 39.20% (26.89-56.24%) for antibiotic use.
CONCLUSION


","['children aged 6 to 35\u202fmonths: Analysis of data from a phase III trial in the Northern and Southern Hemispheres', 'Northern and Southern Hemispheres', 'children aged 6-23 and 24-35\u202fmonths', 'children 6-35\u202fmonths of age']","['EudraCT', 'quadrivalent split-virion inactivated influenza vaccine (IIV4', 'placebo', 'quadrivalent inactivated influenza vaccine']","['healthcare medical visits', 'acute otitis media']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0042760', 'cui_str': 'Viral Particles'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0271429', 'cui_str': 'Acute otitis media (disorder)'}]",,0.181071,"Compared to placebo, IIV4 reduced the risk (95% CI) by 31.28% (8.96-89.34%) for acute otitis media, 21.76% (6.46-58.51%) for acute lower respiratory infection, 40.80% (29.62-55.59%) for healthcare medical visits, 29.71% (11.66-67.23%) for parent absenteeism from work, and 39.20% (26.89-56.24%) for antibiotic use.
CONCLUSION


","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Pepin', 'Affiliation': ""Sanofi Pasteur, 1541 Avenue Marcel Merieux, 69820 Marcy-l'Étoile, France. Electronic address: stephanie.pepin@sanofi.com.""}, {'ForeName': 'Sandrine I', 'Initials': 'SI', 'LastName': 'Samson', 'Affiliation': 'Sanofi Pasteur, 1 Discovery Dr, Swiftwater, PA 18370, USA. Electronic address: Sandrine.Samson@sanofi.com.'}, {'ForeName': 'Fabian P', 'Initials': 'FP', 'LastName': 'Alvarez', 'Affiliation': 'Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France. Electronic address: Fabian.Alvarez@sanofi.com.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dupuy', 'Affiliation': ""Sanofi Pasteur, 1541 Avenue Marcel Merieux, 69820 Marcy-l'Étoile, France. Electronic address: Martin.Dupuy@sanofi.com.""}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Gresset-Bourgeois', 'Affiliation': 'Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France. Electronic address: Viviane.Gresset-Bourgeois@sanofi.com.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'De Bruijn', 'Affiliation': ""Sanofi Pasteur, 1541 Avenue Marcel Merieux, 69820 Marcy-l'Étoile, France. Electronic address: Iris.DeBruijn@sanofi.com.""}]",Vaccine,['10.1016/j.vaccine.2019.01.059']
678,30836781,Mental Contrasting With Implementation Intentions Reduces Drinking When Drinking Is Hazardous: An Online Self-Regulation Intervention.,"Introduction . Drinking alcohol has detrimental health consequences, and effective interventions to reduce hazardous drinking are needed. The self-regulation intervention of Mental Contrasting with Implementation Intentions (MCII) promotes behavior change across a variety of health behaviors. In this study, we tested if online delivery of MCII reduced hazardous drinking in people who were worried about their drinking.  Method . Participants ( N  = 200, female = 107) were recruited online. They were randomized to learn MCII or solve simple math problems (control).  Results . Immediately after the intervention, participants in the MCII condition (vs. control) reported an increased commitment to reduce drinking. After 1 month, they reported having taken action measured by the Readiness to Change drinking scale. When drinking was hazardous (Alcohol Use Disorders Identification Test ≥ 8,  n  = 85), participants in the MCII condition indicated a decreased number of drinking days, exp(β) = 0.47, CI (confidence interval) [-1.322, -.207],  p  = .02, and drinks per week, exp(β) = 0.57, CI [0.94, 5.514],  p  = .007, compared with the control condition.  Discussion . These findings demonstrate that a brief, self-guided online intervention ( Mdn  = 28 minutes) can reduce drinking in people who worry about their drinking. Our findings show a higher impact in people at risk for hazardous drinking.  Conclusion . MCII is scalable as an online intervention. Future studies should test the cost-effectiveness of the intervention in real-world settings.",2019,"Immediately after the intervention, participants in the MCII condition (vs. control) reported an increased commitment to reduce drinking.","['Participants ( N = 200, female = 107', 'people at risk for hazardous drinking', 'people who were worried about their drinking', 'Mental Contrasting with Implementation Intentions']","['Mental Contrasting With Implementation Intentions', 'learn MCII or solve simple math problems (control', 'MCII']","['number of drinking days, exp(β) ', 'Drinking']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.0388857,"Immediately after the intervention, participants in the MCII condition (vs. control) reported an increased commitment to reduce drinking.","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Wittleder', 'Affiliation': '1 University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kappes', 'Affiliation': '3 University of Oxford, Oxford, England.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Oettingen', 'Affiliation': '1 University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Gollwitzer', 'Affiliation': '2 New York University, New York, NY, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Jay', 'Affiliation': '1 University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Morgenstern', 'Affiliation': '5 Northwell Health, New York, NY, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198119826284']
679,30854874,Effects of Acceptance and Commitment Therapy on Impulsive Decision-Making.,"This study examined the transdiagnostic effect of acceptance and commitment therapy (ACT) on impulsive decision-making in a community sample. A total of 40 adults were randomized to eight individual sessions of ACT or an inactive control. Participants completed pre-, mid-, and post-assessments for psychological symptoms; overall behavior change; valued living; delay discounting; psychological flexibility; and distress tolerance. Data were analyzed with multilevel modeling of growth curves. Significant interaction effects of time and condition were observed for psychological flexibility, distress tolerance, psychological symptoms, and the obstruction subscale of valued living. No significant interaction effect was found for two delay discounting tasks nor the progress subscale of valued living. The ACT condition had a significantly larger reduction of problem behavior at post-assessment. The results support use of ACT as a transdiagnostic treatment for impulsive behaviors. The lack of change in delay discounting contrasts previous research.",2020,"Significant interaction effects of time and condition were observed for psychological flexibility, distress tolerance, psychological symptoms, and the obstruction subscale of valued living.",['40 adults'],"['Acceptance and Commitment Therapy', 'acceptance and commitment therapy (ACT', 'ACT', 'ACT or an inactive control']","['psychological symptoms; overall behavior change; valued living; delay discounting; psychological flexibility; and distress tolerance', 'psychological flexibility, distress tolerance, psychological symptoms, and the obstruction subscale of valued living', 'progress subscale of valued living', 'problem behavior']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3850035', 'cui_str': 'Intertemporal Decision Making'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0233514', 'cui_str': 'Behavioral Problem'}]",40.0,0.0463857,"Significant interaction effects of time and condition were observed for psychological flexibility, distress tolerance, psychological symptoms, and the obstruction subscale of valued living.","[{'ForeName': 'Kate L', 'Initials': 'KL', 'LastName': 'Morrison', 'Affiliation': 'Utah Center for Evidence Based Treatment, Salt Lake City, UT, USA.'}, {'ForeName': 'Brooke M', 'Initials': 'BM', 'LastName': 'Smith', 'Affiliation': 'Utah State University, Logan, USA.'}, {'ForeName': 'Clarissa W', 'Initials': 'CW', 'LastName': 'Ong', 'Affiliation': 'Utah State University, Logan, USA.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Lee', 'Affiliation': 'Utah State University, Logan, USA.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Friedel', 'Affiliation': 'Utah State University, Logan, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Odum', 'Affiliation': 'Utah State University, Logan, USA.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Madden', 'Affiliation': 'Utah State University, Logan, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ledermann', 'Affiliation': 'Utah State University, Logan, USA.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Rung', 'Affiliation': 'Utah State University, Logan, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Twohig', 'Affiliation': 'Utah State University, Logan, USA.'}]",Behavior modification,['10.1177/0145445519833041']
680,30870245,Predictors of Exercise Training and Physical Activity Adherence in People Recently Hospitalized With Heart Failure: A BRIEF REPORT.,"PURPOSE


For individuals with heart failure (HF), frequent attendance at exercise training programs and meeting physical activity (PA) guidelines are significantly associated with improvements in 6-min walk distance. Despite the evidence, adherence to exercise interventions remains poor. The aim of this study was to identify predictors of these 2 variables in patients recently hospitalized with HF.
METHODS


In this substudy of the Exercise Joins Education: Combined Therapy to Improve Outcomes in Newly-discharged Heart Failure (EJECTION-HF) trial, all participants were enrolled in a HF disease management program, including weekly review of a home exercise program for 12 wk. Intervention group participants additionally undertook twice weekly supervised exercise training. Primary outcomes were frequent exercise training program attendance (≥12 sessions) and attainment of PA guidelines (150 min/wk of moderate intensity exercise) at 12 wk. Participant and clinical characteristics were analyzed using a logistic regression model to identify significant predictors of each outcome.
RESULTS


A total of 278 participants provided PA data and 140 contributed attendance data. New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03). Predictors of meeting PA guidelines at follow-up included new HF diagnosis (OR = 2.4; 95% CI, 1.2-4.8, P = .013), and being physically active at baseline (OR = 2.7; 95% CI, 1.3-5.6; P = .007). Gender, symptom severity, multimorbidity, and disability were not significantly associated with either outcome in multivariate analysis.
CONCLUSION


To improve adherence, specific strategies may be required for patients with decompensated HF and those physically inactive at time of referral.",2019,"New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03).","['278 participants provided PA data and 140 contributed attendance data', 'Newly-discharged Heart Failure (EJECTION-HF) trial, all participants were enrolled in a HF disease management program, including weekly review of a home exercise program for 12 wk', 'individuals with heart failure (HF', 'patients with decompensated HF and those physically inactive at time of referral', 'People Recently Hospitalized With Heart Failure']","['Exercise Training and Physical Activity Adherence', 'supervised exercise training']","['Gender, symptom severity, multimorbidity, and disability', 'frequent exercise training program attendance (≥12 sessions) and attainment of PA guidelines', 'frequent program attendance']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0336969', 'cui_str': 'Ejection (qualifier value)'}, {'cui': 'C1303150', 'cui_str': 'Disease management program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0699752', 'cui_str': 'Review of (contextual qualifier) (qualifier value)'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",278.0,0.0700865,"New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03).","[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Adsett', 'Affiliation': ""Heart Support Service (Ms Adsett) and Departments of Physiotherapy (Ms Adsett) and Internal Medicine and Aged Care (Dr Mudge), Royal Brisbane and Women's Hospital, Brisbane, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Australia (Ms Adsett and Dr Morris); Menzies Health Institute, Queensland, Australia (Ms Adsett and Dr Morris); Metro North Hospital and Health Service, The Prince Charles Hospital, Allied Health Research Collaborative, Queensland, Australia (Dr Morris); and University of Queensland Faculty of Medicine, Brisbane, Queensland, Australia (Dr Mudge).""}, {'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Mudge', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000407']
681,29952302,A randomized comparison of combined itraconazole and Nd:YAG 1064-nm laser vs itraconazole alone for the treatment of cutaneous sporotrichosis.,,2018,,['cutaneous sporotrichosis'],['combined itraconazole and Nd:YAG 1064-nm laser vs itraconazole alone'],[],"[{'cui': 'C0276726', 'cui_str': 'Cutaneous sporotrichosis (disorder)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}]",[],,0.0189051,,"[{'ForeName': 'Jinran', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'China-Japan Union Hospital of Jilin University, 126 Xiantai St, Erdao, Changchun, Jilin 130033, China.'}, {'ForeName': 'Mingji', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'China-Japan Union Hospital of Jilin University, 126 Xiantai St, Erdao, Changchun, Jilin 130033, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'China-Japan Union Hospital of Jilin University, 126 Xiantai St, Erdao, Changchun, Jilin 130033, China.'}, {'ForeName': 'Jinlan', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'China-Japan Union Hospital of Jilin University, 126 Xiantai St, Erdao, Changchun, Jilin 130033, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'China-Japan Union Hospital of Jilin University, 126 Xiantai St, Erdao, Changchun, Jilin 130033, China.'}, {'ForeName': 'Rihua', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'China-Japan Union Hospital of Jilin University, 126 Xiantai St, Erdao, Changchun, Jilin 130033, China.'}, {'ForeName': 'Yuxi', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'China-Japan Union Hospital of Jilin University, 126 Xiantai St, Erdao, Changchun, Jilin 130033, China.'}]",European journal of dermatology : EJD,['10.1684/ejd.2018.3343']
682,30765508,"A randomised, placebo-controlled study of omipalisib (PI3K/mTOR) in idiopathic pulmonary fibrosis.","Phosphatidylinositol 3-kinases (PI3Ks) and mammalian target of rapamycin (mTOR) play a role in the pathogenesis of idiopathic pulmonary fibrosis (IPF). Omipalisib (GSK2126458) is a potent inhibitor of PI3K/mTOR.A randomised, placebo-controlled, double-blind, repeat dose escalation, experimental medicine study of omipalisib in subjects with IPF was conducted (NCT01725139) to test safety, tolerability, pharmacokinetics and pharmacodynamics. Omipalisib was dosed at 0.25 mg, 1 mg and 2 mg twice daily for 8 days in four cohorts of four subjects randomised 3:1 to receive omipalisib or placebo (two cohorts received 2 mg twice daily).17 subjects with IPF were enrolled. The most common adverse event was diarrhoea, which was reported by four participants. Dose-related increases in insulin and glucose were observed. Pharmacokinetic analysis demonstrated that exposure in the blood predicts lung exposure. Exposure-dependent inhibition of phosphatidylinositol 3,4,5 trisphosphate and pAKT confirmed target engagement in blood and lungs.  18 F-2 - fluoro-2-deoxy-d-glucose(FDG)-positron emission tomography/computed tomography scans revealed an exposure-dependent reduction in  18 F-FDG uptake in fibrotic areas of the lung, as measured by target-to-background, ratio thus confirming pharmacodynamic activity.This experimental medicine study demonstrates acceptable tolerability of omipalisib in subjects with IPF at exposures for which target engagement was confirmed both systemically and in the lungs.",2019,"Exposure-dependent inhibition of phosphatidylinositol 3,4,5 trisphosphate and pAKT confirmed target engagement in blood and lungs.  ","['idiopathic pulmonary fibrosis (IPF', 'subjects with IPF at exposures', 'subjects with IPF', 'idiopathic pulmonary fibrosis', 'daily).17 subjects with IPF were enrolled', '18']","['Phosphatidylinositol 3-kinases (PI3Ks) and mammalian target of rapamycin (mTOR', 'placebo', 'omipalisib or placebo', 'F-2 - fluoro-2-deoxy-d-glucose(FDG)-positron emission tomography/computed tomography scans', 'omipalisib (PI3K/mTOR', 'Omipalisib']","['safety, tolerability, pharmacokinetics and pharmacodynamics', 'insulin and glucose']","[{'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0044602', 'cui_str': 'Phosphoinositide 3 Kinase'}, {'cui': 'C0293060', 'cui_str': 'Mammalian Target of Rapamycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0092882', 'cui_str': '2-Fluoro-2-deoxy-D-glucose'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0441633'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]",,0.218541,"Exposure-dependent inhibition of phosphatidylinositol 3,4,5 trisphosphate and pAKT confirmed target engagement in blood and lungs.  ","[{'ForeName': 'Pauline T', 'Initials': 'PT', 'LastName': 'Lukey', 'Affiliation': 'GlaxoSmithKline Research and Development, Stevenage, UK.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'GlaxoSmithKline Research and Development, Stevenage, UK.'}, {'ForeName': 'Shuying', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'GlaxoSmithKline Research and Development, Stevenage, UK.'}, {'ForeName': 'Yim', 'Initials': 'Y', 'LastName': 'Man', 'Affiliation': 'GlaxoSmithKline Research and Development, Stevenage, UK.'}, {'ForeName': 'Beverley F', 'Initials': 'BF', 'LastName': 'Holman', 'Affiliation': 'University College London, Institute of Nuclear Medicine, London, UK.'}, {'ForeName': 'Alaleh', 'Initials': 'A', 'LastName': 'Rashidnasab', 'Affiliation': 'University College London, Institute of Nuclear Medicine, London, UK.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Azzopardi', 'Affiliation': 'University College London, Institute of Nuclear Medicine, London, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Grayer', 'Affiliation': 'GlaxoSmithKline Research and Development, Stevenage, UK.'}, {'ForeName': 'Juliet K', 'Initials': 'JK', 'LastName': 'Simpson', 'Affiliation': 'GlaxoSmithKline Research and Development, Stevenage, UK.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Bareille', 'Affiliation': 'GlaxoSmithKline Research and Development, Stevenage, UK.'}, {'ForeName': 'Lyn', 'Initials': 'L', 'LastName': 'Paul', 'Affiliation': 'NIHR Respiratory Clinical Research Facility, Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Hannah V', 'Initials': 'HV', 'LastName': 'Woodcock', 'Affiliation': 'University College London, Centre for Inflammation and Tissue Repair, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Toshner', 'Affiliation': 'NIHR Respiratory Clinical Research Facility, Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Saunders', 'Affiliation': 'NIHR Respiratory Clinical Research Facility, Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Philip L', 'Initials': 'PL', 'LastName': 'Molyneaux', 'Affiliation': 'NIHR Respiratory Clinical Research Facility, Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Thielemans', 'Affiliation': 'University College London, Institute of Nuclear Medicine, London, UK.'}, {'ForeName': 'Frederick J', 'Initials': 'FJ', 'LastName': 'Wilson', 'Affiliation': 'GlaxoSmithKline Research and Development, Stevenage, UK.'}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Mercer', 'Affiliation': 'University College London, Centre for Inflammation and Tissue Repair, London, UK.'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Chambers', 'Affiliation': 'University College London, Centre for Inflammation and Tissue Repair, London, UK.'}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Groves', 'Affiliation': 'University College London, Institute of Nuclear Medicine, London, UK.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Fahy', 'Affiliation': 'GlaxoSmithKline Research and Development, Stevenage, UK.'}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Marshall', 'Affiliation': 'GlaxoSmithKline Research and Development, Stevenage, UK.'}, {'ForeName': 'Toby M', 'Initials': 'TM', 'LastName': 'Maher', 'Affiliation': 'NIHR Respiratory Clinical Research Facility, Royal Brompton Hospital, London, UK t.maher@imperial.ac.uk.'}]",The European respiratory journal,['10.1183/13993003.01992-2018']
683,30715489,Comparative Effectiveness of mHealth-Supported Exercise Compared With Exercise Alone for People With Parkinson Disease: Randomized Controlled Pilot Study.,"Background


Declining physical activity commonly occurs in people with Parkinson disease (PD) and contributes to reduced functional capacity and quality of life.
Objective


The purpose of this study was to explore the preliminary effectiveness, safety, and acceptability of a mobile health (mHealth)-mediated exercise program designed to promote sustained physical activity in people with PD.
Design


This was a 12-month single-blind (assessor), pilot, comparative-effectiveness, randomized controlled study.
Methods


An mHealth-mediated exercise program (walking with a pedometer plus engagement in planned exercise supported by a mobile health application) was compared over 1 year with an active control condition (walking with a pedometer and exercise only). There were 51 participants in a community setting with mild-to-moderately severe (Hoehn and Yahr stages 1-3) idiopathic PD. Daily steps and moderate-intensity minutes were measured using a step activity monitor for 1 week at baseline and again at 12 months. Secondary outcomes included the 6-Minute Walk Test, Parkinson Disease Questionnaire 39 mobility domain, safety, acceptability, and adherence.
Results


Both groups increased daily steps, moderate-intensity minutes, and 6-Minute Walk Test, with no statistically significant between-group differences observed. In the less active subgroup, changes in daily steps and moderate-intensity minutes were clinically meaningful. An improvement in the Parkinson Disease Questionnaire 39 mobility score favored mHealth in the overall comparison and was statistically and clinically meaningful in the less active subgroup.
Limitations


The limitation of the current study was the small sample size.
Conclusions


Both groups improved physical activity compared with expected activity decline over 1 year. The addition of the mHealth app to the exercise intervention appeared to differentially benefit the more sedentary participants. Further study in a larger group of people with low activity at baseline is needed.",2019,"Both groups increased daily steps, moderate-intensity minutes, and 6-Minute Walk Test, with no statistically significant between-group differences observed.","['people with Parkinson disease (PD', '51 participants in a community setting with mild-to-moderately severe (Hoehn and Yahr stages 1-3) idiopathic PD', 'people with PD', 'People With Parkinson Disease', 'sedentary participants']","['exercise intervention', 'mobile health (mHealth)-mediated exercise program', 'mHealth-Supported Exercise Compared With Exercise Alone', 'mHealth-mediated exercise program (walking with a pedometer plus engagement in planned exercise supported by a mobile health application']","['physical activity', 'Parkinson Disease Questionnaire 39 mobility score', 'daily steps, moderate-intensity minutes, and 6-Minute Walk Test', '6-Minute Walk Test, Parkinson Disease Questionnaire 39 mobility domain, safety, acceptability, and adherence']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",51.0,0.135561,"Both groups increased daily steps, moderate-intensity minutes, and 6-Minute Walk Test, with no statistically significant between-group differences observed.","[{'ForeName': 'Terry D', 'Initials': 'TD', 'LastName': 'Ellis', 'Affiliation': 'Department of Physical Therapy and Athletic Training, Sargent College of Health and Rehabilitation Sciences, Boston University, 635 Commonwealth Ave, Boston, MA 02215 (USA); and Center for Neurorehabilitation, Boston University.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Cavanaugh', 'Affiliation': 'Department of Physical Therapy, University of New England, Portland, Maine.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'DeAngelis', 'Affiliation': 'Department of Physical Therapy and Athletic Training, Sargent College of Health and Rehabilitation Sciences, Boston University.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Hendron', 'Affiliation': 'Department of Physical Therapy and Athletic Training, Sargent College of Health and Rehabilitation Sciences, Boston University.'}, {'ForeName': 'Cathi A', 'Initials': 'CA', 'LastName': 'Thomas', 'Affiliation': ""Department of Neurology, Parkinson's Disease and Movement Disorders Center, Boston University.""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Saint-Hilaire', 'Affiliation': ""Department of Neurology, Parkinson's Disease and Movement Disorders Center, Boston University.""}, {'ForeName': 'Karol', 'Initials': 'K', 'LastName': 'Pencina', 'Affiliation': ""Research Program in Men's Health, Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Nancy K', 'Initials': 'NK', 'LastName': 'Latham', 'Affiliation': ""Research Program in Men's Health, Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School.""}]",Physical therapy,['10.1093/ptj/pzy131']
684,30821349,Dexmedetomidine versus propofol at different sedation depths during drug-induced sleep endoscopy: A randomized trial.,"OBJECTIVES/HYPOTHESIS


The aim of this study was to compare the effect of dexmedetomidine and propofol on airway dynamics, cardiorespiratory system, and emergence following drug-induced sleep endoscopy (DISE).
STUDY DESIGN


Prospective, randomized, single-blinded study.
METHODS


Sixty patients age 18 to 65 years in American Society of Anesthesiologists physical status groups 1 and 2 scheduled to undergo DISE were randomly allocated to either Group P (N = 30; receiving propofol infusion at 50-150 μg/kg/min) or Group D (N = 30; receiving dexmedetomidine bolus of 1 μg/kg followed by infusion at 0.5-1.0 μg/kg/hr). DISE was done at light sleep and deep sleep. Airway obstruction at tongue base was recorded as primary outcome. Airway obstruction at velum, oropharyngeal lateral wall, and epiglottis level during light and deep sedation, hemodynamic and respiratory parameters, time to attain sufficient sedation, time for emergence from sedation, and any adverse events during DISE with the two study drugs were recorded as secondary outcomes.
RESULTS


There was a greater degree of obstruction at the tongue base level (P = 0.001) and Oropharynx level (P = 0.017) in Group P compared with Group D during deep sedation. Increase in airway obstruction from light to deep sleep was seen with propofol at the oropharynx (P = 0.0185) and tongue base (P = 0.0108) levels. Two patients (6.6%) in Group D and 10 patients (33.3%) in Group P showed oxygen saturation below the minimum oxygen saturation recorded during polysomnography. Time to open eyes to call after stopping sedation was significantly less in Group P (P = 0.005).
CONCLUSIONS


Dexmedetomidine shows a lesser degree of airway collapse and higher oxygen saturation levels at greater sedation depth during DISE. Propofol has a faster onset and emergence from sedation.
LEVEL OF EVIDENCE


1b Laryngoscope, 130:257-262, 2020.",2020,"Time to open eyes to call after stopping sedation was significantly less in Group P (P = 0.005).
","['Sixty patients age 18 to 65\u2009years in American Society of Anesthesiologists physical status groups 1 and 2 scheduled to undergo DISE', 'drug-induced sleep endoscopy']","['Dexmedetomidine', 'DISE', 'propofol', 'propofol infusion', 'dexmedetomidine and propofol', 'dexmedetomidine', 'Propofol']","['Oropharynx level', 'degree of airway collapse and higher oxygen saturation levels', 'oxygen saturation below the minimum oxygen saturation', 'Airway obstruction at velum, oropharyngeal lateral wall, and epiglottis level during light and deep sedation, hemodynamic and respiratory parameters, time to attain sufficient sedation, time for emergence from sedation, and any adverse events', 'degree of obstruction', 'airway obstruction from light to deep sleep', 'airway dynamics, cardiorespiratory system, and emergence following drug-induced sleep endoscopy (DISE']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0458082', 'cui_str': 'Drug-induced (qualifier value)'}, {'cui': 'C0396283', 'cui_str': 'Sleep nasendoscopy (procedure)'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0521367', 'cui_str': 'Oropharynxs'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0392748', 'cui_str': 'Collapsed (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0001883', 'cui_str': 'Airway Obstruction'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0014540', 'cui_str': 'Epiglottic Cartilage'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C1956064', 'cui_str': 'Deep Sedation'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0458082', 'cui_str': 'Drug-induced (qualifier value)'}, {'cui': 'C0396283', 'cui_str': 'Sleep nasendoscopy (procedure)'}]",60.0,0.101284,"Time to open eyes to call after stopping sedation was significantly less in Group P (P = 0.005).
","[{'ForeName': 'Tonsy V', 'Initials': 'TV', 'LastName': 'Padiyara', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Bansal', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Jain', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Gandhi', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}]",The Laryngoscope,['10.1002/lary.27903']
685,30803843,"Immunogenicity, safety, cross-reaction, and immune persistence of an inactivated enterovirus A71 vaccine in children aged from two months to 11 years in Taiwan.","BACKGROUND


To fight against enterovirus A71 (EV-A71)-associated diseases, vaccine development was initiated in Taiwan focusing on two-month-old infants.
METHODS


We conducted a phase II, double-blind, randomised, placebo-controlled study on infants and children aged two months to 11 years. This study was conducted in 4 parts (2a, 2b, 2c, and 2d) with age de-escalation sequentially. Two doses were administered with a 28-day or 56-day interval. Participants aged two months to <two years received a booster dose at one year after the first dose. During the surveillance period, solicited adverse events (AEs) and unsolicited AEs were recorded for safety evaluation. Blood samples were collected for neutralising antibody assay at various times. Immune persistence and booster effects were also assessed.
RESULTS


A total of 363 children completed the study. Most AEs were mild and unrelated to treatment. No vaccine-related serious adverse events (SAEs) were reported. Geometric mean titres (GMTs) of serum neutralising antibody titres increased profoundly. Most participants in the vaccine groups achieved defined seroprotection (neutralization titre ≥ 1:32) after the second vaccination and persisted for two years. Furthermore, the EV-A71 vaccine could provide a cross-reaction against other EV-A71 strain genotypes: B5, C4a, C4b, and C5.
CONCLUSIONS


The mid dose of the EV-A71 vaccine elicited high immune response and were tolerable in participants aged between two months and 11 years in all dosing groups.",2019,Geometric mean titres (GMTs) of serum neutralising antibody titres increased profoundly.,"['infants and children aged two months to 11\u202fyears', 'Taiwan focusing on two-month-old infants', 'Participants aged two months to <two years', 'participants aged between two months and 11\u202fyears in all dosing groups', 'children aged from two months to 11 years in Taiwan', '4 parts (2a, 2b, 2c, and 2d) with age de-escalation sequentially', '363 children completed the study']","['placebo', 'inactivated enterovirus A71 vaccine']","['Geometric mean titres (GMTs) of serum neutralising antibody titres', 'Immunogenicity, safety, cross-reaction, and immune persistence', 'seroprotection (neutralization titre', 'solicited adverse events (AEs) and unsolicited AEs', 'Immune persistence and booster effects']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0014383', 'cui_str': 'Enterovirus'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010357', 'cui_str': 'Cross Reactions'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1697762', 'cui_str': 'Booster'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",363.0,0.231767,Geometric mean titres (GMTs) of serum neutralising antibody titres increased profoundly.,"[{'ForeName': 'Li-Min', 'Initials': 'LM', 'LastName': 'Huang', 'Affiliation': ""Department of Pediatrics, National Taiwan University Children's Hospital, Taipei, Taiwan.""}, {'ForeName': 'Cheng-Hsun', 'Initials': 'CH', 'LastName': 'Chiu', 'Affiliation': ""Department of Pediatrics, Chang Gung Children's Hospital, Chang Gung University College of Medicine, Taoyuan, Taiwan.""}, {'ForeName': 'Nan-Chang', 'Initials': 'NC', 'LastName': 'Chiu', 'Affiliation': ""Department of Pediatrics, MacKay Children's Hospital, Taipei, Taiwan; Department of Medicine, Mackay Medical College, New Taipei City, Taiwan.""}, {'ForeName': 'Chien-Yu', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Department of Pediatrics, Hsinchu MacKay Memorial Hospital, Hsinchu, Taiwan.'}, {'ForeName': 'Ming-Ta', 'Initials': 'MT', 'LastName': 'Li', 'Affiliation': 'Department of Pediatrics, Hsinchu MacKay Memorial Hospital, Hsinchu, Taiwan.'}, {'ForeName': 'Tsun-Yung', 'Initials': 'TY', 'LastName': 'Kuo', 'Affiliation': 'Department of Biotechnology and Animal Science, National Ilan University, Ilan, Taiwan.'}, {'ForeName': 'Yi-Jen', 'Initials': 'YJ', 'LastName': 'Weng', 'Affiliation': 'Clinical Development Department, Medigen Vaccine Biologics Corp., Taipei, Taiwan.'}, {'ForeName': 'Erh-Fang', 'Initials': 'EF', 'LastName': 'Hsieh', 'Affiliation': 'Clinical Development Department, Medigen Vaccine Biologics Corp., Taipei, Taiwan.'}, {'ForeName': 'I-Chen', 'Initials': 'IC', 'LastName': 'Tai', 'Affiliation': 'Clinical Development Department, Medigen Vaccine Biologics Corp., Taipei, Taiwan. Electronic address: kathytai@medigenvac.com.'}]",Vaccine,['10.1016/j.vaccine.2019.02.023']
686,20357033,Maintenance of physical activity and body weight in relation to subsequent quality of life in postmenopausal breast cancer patients.,"BACKGROUND


We prospectively examined the association between physical activity, body weight and quality of life in Dutch postmenopausal early breast cancer patients treated with adjuvant endocrine therapy.
PATIENTS AND METHODS


In this side study of a large clinical trial, lifestyle and quality-of-life questionnaires were filled out 1 and 2 years after the start of endocrine therapy (T1 and T2, respectively) and included a pre-diagnosis lifestyle assessment (T0). A total of 435 breast cancer patients returned both questionnaires.
RESULTS


Individuals with a physical activity level above the median who maintained this level from T0 to T1 reported the best global quality of life and physical functioning and the least fatigue at T2, as compared with individuals with low levels of physical activity which further decreased after diagnosis (difference of +16, +14, and -22 points on a 0-100 quality-of-life scale, respectively; P < 0.01). Overweight or obese women who gained body weight after diagnosis reported worst quality of life and most fatigue as compared with women who maintained a stable body weight (difference of -8, -10 and +2 points, respectively; P < 0.01).
CONCLUSION


Maintaining high pre-diagnosis physical activity levels and a healthy body weight is associated with better quality of life after breast cancer.",2010,Maintaining high pre-diagnosis physical activity levels and a healthy body weight is associated with better quality of life after breast cancer.,"['Dutch postmenopausal early breast cancer patients treated with adjuvant endocrine therapy', 'postmenopausal breast cancer patients', '435 breast cancer patients returned both questionnaires']",[],"['global quality of life and physical functioning', 'quality of life and most fatigue', 'physical activity, body weight and quality of life', 'physical activity level']","[{'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",[],"[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",435.0,0.0235855,Maintaining high pre-diagnosis physical activity levels and a healthy body weight is associated with better quality of life after breast cancer.,"[{'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Voskuil', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Amsterdam. Electronic address: d.w.voskuil@hhs.nl.'}, {'ForeName': 'J G H', 'Initials': 'JGH', 'LastName': 'van Nes', 'Affiliation': 'Department of Surgery, Leiden University Medical Centre, Leiden.'}, {'ForeName': 'J M C', 'Initials': 'JMC', 'LastName': 'Junggeburt', 'Affiliation': 'Department of Surgery, Leiden University Medical Centre, Leiden.'}, {'ForeName': 'C J H', 'Initials': 'CJH', 'LastName': 'van de Velde', 'Affiliation': 'Department of Surgery, Leiden University Medical Centre, Leiden.'}, {'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'van Leeuwen', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Amsterdam.'}, {'ForeName': 'J C J M', 'Initials': 'JCJM', 'LastName': 'de Haes', 'Affiliation': 'Department of Medical Psychology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq151']
687,30808567,Immunogenicity of pentavalent rotavirus vaccine in Chinese infants.,"BACKGROUND


A phase III, randomized, double-blind, placebo-controlled clinical study was conducted in China to assess the efficacy, safety, and immunogenicity of the pentavalent rotavirus vaccine (RotaTeq TM , RV5) among Chinese infants. The efficacy and safety data have been previously reported. This report presents the immunogenicity data of the study.
METHODS


4,040 infants aged 6-12 weeks were randomly assigned in a 1:1 ratio to receive 3 oral doses of RV5 or placebo. Trivalent oral poliovirus vaccine (tOPV) and diphtheria, tetanus, and acellular pertussis vaccine (DTaP) were administered in a staggered-use (N = 3,240) or concomitant-use (N = 800) schedule. Immunogenicity of RV5 was evaluated in 800 participants (400 participants from each staggered- and concomitant-use immunogenicity subgroup). Geometric mean titers (GMTs) and seroresponse rates (≥3-fold rise from baseline to PD3) were measured for anti-rotavirus IgA in the staggered- and concomitant-use subgroups and measured for serum neutralizing antibodies (SNAs) to human rotavirus serotypes G1, G2, G3, G4, P1A[8] in the staggered-use subgroup. Immune responses to tOPV and DTaP co-administered with RV5 were also evaluated in the concomitant-use immunogenicity subgroup. (ClinicalTrials.gov registry: NCT02062385) RESULTS: The PD3 GMT and seroresponse rate of anti-rotavirus IgA were higher in the RV5 group (82.42 units/mL, 89.4%) compared to the placebo group (0.33 units/mL, 10.1%). Rotavirus type-specific SNA responses were also higher in the RV5 group compared to the placebo group. In the concomitant-use subgroup, the seroprotection rates of anti-poliovirus type 1, 2, 3 in the participants who received RV5 were non-inferior to those who received placebo, and the antibody responses to DTaP antigens were comparable between the two vaccination groups.
CONCLUSIONS


RV5 was immunogenic in Chinese infants. Immune responses induced by tOPV and DTaP were not affected by the concomitant use of RV5.",2019,"The PD3 GMT and seroresponse rate of anti-rotavirus IgA were higher in the RV5 group (82.42 units/mL, 89.4%) compared to the placebo group (0.33 units/mL, 10.1%).","['800 participants (400 participants from each staggered- and concomitant-use immunogenicity subgroup', '4,040 infants aged 6-12\u202fweeks', 'Chinese infants']","['tOPV and DTaP co-administered with RV5', 'Trivalent oral poliovirus vaccine (tOPV) and diphtheria, tetanus, and acellular pertussis vaccine (DTaP', 'placebo', 'pentavalent rotavirus vaccine (RotaTeq TM , RV5', 'pentavalent rotavirus vaccine', 'RV5 or placebo']","['Geometric mean titers (GMTs) and seroresponse rates (≥3-fold rise from baseline to PD3', 'PD3 GMT and seroresponse rate of anti-rotavirus IgA', 'Immunogenicity of RV5', 'Rotavirus type-specific SNA responses', 'seroprotection rates', 'Immunogenicity', 'efficacy, safety, and immunogenicity']","[{'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C0032375', 'cui_str': 'Sabin Vaccine'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0982332', 'cui_str': 'acellular pertussis vaccine, inactivated'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2713569', 'cui_str': 'pentavalent rotavirus vaccine (RV5)'}, {'cui': 'C1528013', 'cui_str': 'RotaTeq'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C3476459', 'cui_str': 'Rotavirus IgA'}, {'cui': 'C0035870', 'cui_str': 'Rotavirus'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",4040.0,0.425701,"The PD3 GMT and seroresponse rate of anti-rotavirus IgA were higher in the RV5 group (82.42 units/mL, 89.4%) compared to the placebo group (0.33 units/mL, 10.1%).","[{'ForeName': 'Zhaojun', 'Initials': 'Z', 'LastName': 'Mo', 'Affiliation': 'Guangxi Center for Disease Control and Prevention, Guangxi, PR China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing, PR China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Luo', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing, PR China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Mo', 'Affiliation': 'Guangxi Center for Disease Control and Prevention, Guangxi, PR China.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Kaplan', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Shou', 'Affiliation': 'MSD R&D (China) Co., Ltd., Beijing, PR China.'}, {'ForeName': 'Minghuan', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'MSD R&D (China) Co., Ltd., Beijing, PR China.'}, {'ForeName': 'Darcy A', 'Initials': 'DA', 'LastName': 'Hille', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Arnold', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Xueyan', 'Initials': 'X', 'LastName': 'Liao', 'Affiliation': 'MSD R&D (China) Co., Ltd., Beijing, PR China. Electronic address: xue.yan.liao@merck.com.'}]",Vaccine,['10.1016/j.vaccine.2019.02.018']
688,31702714,Phacoemulsification Versus Phacotrabeculectomy in Primary Angle-closure Glaucoma With Cataract: Long-Term Clinical Outcomes.,"PRECIS


Phacotrabeculectomy was more effective in reducing intraocular pressure (IOP) and glaucoma drugs than phacoemulsification alone in primary angle-closure glaucoma (PACG) eyes with cataract but was associated with more postoperative complications, up to 5 years after surgery.
PURPOSE


The purpose of this study was to compare long-term clinical outcomes of phacoemulsification versus phacotrabeculectomy in PACG eyes with cataract.
PATIENTS AND METHODS


The 2 initial prospective randomized controlled trials recruited PACG eyes with cataract using the same criteria and randomized these eyes to receiving either phacoemulsification or phacotrabeculectomy. Clinical data up to 5 years of follow-up were pooled for retrospective analysis.
RESULTS


Clinical data of 35 patients in the phacoemulsification group and 44 patients in the phacotrabeculectomy group were analyzed. At 5 years after surgery, the mean IOP was decreased by 20.7% and 29.5% from before surgery to 5 years after phacoemulsification and phacotrabeculectomy, respectively (P<0.001 for both groups). Phacotrabeculectomy was significantly more effective than phacoemulsification in reducing IOP up to 5 years after surgery (P<0.001). At 5 years, the mean number of glaucoma drugs required±1 SD was 1.6±1.2 in the phacoemulsification group, and 0.7±1.0 in the phacotrabeculectomy group (P=0.004). Phacotrabeculectomy was associated with more postoperative complications than phacoemulsification up to 5 years (25 complications in the phacotrabeculectomy group versus 6 in the phacoemulsification group, P<0.001).
CONCLUSIONS


Phacoemulsification alone reduces IOP and the need for glaucoma drugs in PACG eyes with cataracts for up to 5 years. Phacotrabeculectomy was more effective in reducing IOP and glaucoma drugs than phacoemulsification alone but was associated with more postoperative complications, up to 5 years after surgery.",2020,"Phacotrabeculectomy was associated with more postoperative complications than phacoemulsification up to 5 years (25 complications in the phacotrabeculectomy group versus 6 in the phacoemulsification group, P<0.001).
","['Primary Angle-closure Glaucoma', 'PACG eyes with cataract using the same criteria and randomized these eyes to receiving either', 'PACG eyes with cataract', '35 patients in the phacoemulsification group and 44 patients in the phacotrabeculectomy group were analyzed']","['Phacotrabeculectomy', 'phacoemulsification or phacotrabeculectomy', 'phacoemulsification versus phacotrabeculectomy', 'Phacoemulsification Versus Phacotrabeculectomy']","['IOP and glaucoma drugs', 'mean IOP', 'IOP', 'postoperative complications', 'mean number of glaucoma drugs required±1\u2009SD', 'intraocular pressure (IOP) and glaucoma drugs']","[{'cui': 'C0017606', 'cui_str': 'Primary angle-closure glaucoma (disorder)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1167708', 'cui_str': 'Phacotrabeculectomy'}]","[{'cui': 'C1167708', 'cui_str': 'Phacotrabeculectomy'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}]","[{'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}]",,0.0801257,"Phacotrabeculectomy was associated with more postoperative complications than phacoemulsification up to 5 years (25 complications in the phacotrabeculectomy group versus 6 in the phacoemulsification group, P<0.001).
","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Hansapinyo', 'Affiliation': 'Department of Ophthalmology & Visual Sciences, The Chinese University of Hong Kong.'}, {'ForeName': 'Bonnie N K', 'Initials': 'BNK', 'LastName': 'Choy', 'Affiliation': ""Department of Ophthalmology, The University of Hong Kong, Hong Kong SAR, People's Republic of China.""}, {'ForeName': 'Jimmy S M', 'Initials': 'JSM', 'LastName': 'Lai', 'Affiliation': ""Department of Ophthalmology, The University of Hong Kong, Hong Kong SAR, People's Republic of China.""}, {'ForeName': 'Clement C', 'Initials': 'CC', 'LastName': 'Tham', 'Affiliation': 'Department of Ophthalmology & Visual Sciences, The Chinese University of Hong Kong.'}]",Journal of glaucoma,['10.1097/IJG.0000000000001397']
689,30768793,The process of change in psychotherapy with a pregnant patient following perinatal losses: An analysis of a case study.,"AIM


Despite research suggesting increased anxiety and depressive symptoms after a perinatal loss and during future pregnancies, little knowledge exists to guide clinicians treating pregnant women after perinatal loss. This case study explores processes that facilitated therapeutic change for a pregnant patient with major depressive disorder (MDD) and posttraumatic stress disorder after perinatal losses.
METHOD


The study integrated quantitative and narrative analyses in a single case derived from the pilot phase of a randomized controlled trial on supportive-expressive therapy for MDD.
RESULTS


The quantitative and narrative analyses suggest that an improvement in maladaptive interpersonal patterns toward the therapist, in the form of attachment avoidance, made it possible to form a strong alliance, which in turn led to a successful outcome.
CONCLUSIONS


The findings highlight the importance of improving maladaptive interpersonal patterns as a prerequisite to enable patients after pregnancy losses to develop and maintain a corrective therapeutic experience.",2019,"The quantitative and narrative analyses suggest that an improvement in maladaptive interpersonal patterns toward the therapist, in the form of attachment avoidance, made it possible to form a strong alliance, which in turn led to a successful outcome.
",['pregnant patient with major depressive disorder (MDD) and posttraumatic stress disorder after perinatal losses'],['supportive-expressive therapy'],"['anxiety and depressive symptoms', 'maladaptive interpersonal patterns']","[{'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",,0.0417216,"The quantitative and narrative analyses suggest that an improvement in maladaptive interpersonal patterns toward the therapist, in the form of attachment avoidance, made it possible to form a strong alliance, which in turn led to a successful outcome.
","[{'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Cohen', 'Affiliation': 'The Department of Psychology, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Liat', 'Initials': 'L', 'LastName': 'Leibovich', 'Affiliation': 'The Department of Psychology, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Rayna', 'Initials': 'R', 'LastName': 'Markin', 'Affiliation': 'The Department of Education and Counseling, Villanova University, Villanova, Pennsylvania.'}, {'ForeName': 'Sigal', 'Initials': 'S', 'LastName': 'Zilcha-Mano', 'Affiliation': 'The Department of Psychology, University of Haifa, Haifa, Israel.'}]",Journal of clinical psychology,['10.1002/jclp.22763']
690,30741081,Effects of elastic band exercise on the frailty states in pre-frail elderly people.,"OBJECTIVE


To discuss the effects of elastic band exercise on the frailty states in pre-frail elderly people.
METHODS


This study was a randomized controlled trial. Trial registration number is ChiCTR-IOC-17012579. Seventy pre-frail elderly people were randomly divided into elastic band group ( n  = 35) and control group ( n  = 35). Elastic band exercise was applied to elastic band group, 45-60 min per time for 8 weeks by 3 days a week; no exercise was applied to the control group. The frailty states, grip strength (female/male), walking speed, and physical activity were measured by the Fried frailty phenotype at pre-intervention, 4, and 8 weeks after intervention to assess the effects of exercise.
RESULTS


The elastic band group showed significant improvements in the frailty states, grip strength (female) and walking speed both after 4-week and 8-week intervention ( P < 0.001), and significant improvements in grip strength (male) and physical activity after 8-week intervention ( P < 0.05). Within-group analysis (pre-intervention vs. after 4-week, after 4-week vs after 8-week, pre-intervention vs after 8-week) showed significant improvements ( P < 0.001) in grip strength (female/male) and walking speed in the elastic band group over time, while no significant differences in the control group ( P >  0.05).
CONCLUSION


Elastic band exercise can improve frailty states in pre-frail elderly people, make them broke away from pre-frailty and restore them to non-frailty through improving the grip strength, walking speed and physical activity, and the effects after 8 weeks are better than those after 4 weeks.",2020,"The elastic band group showed significant improvements in the frailty states, grip strength (female) and walking speed both after 4-week and 8-week intervention (P< 0.001), and significant improvements in grip strength (male) and physical activity after 8-week intervention (P< 0.05).","['Seventy pre-frail elderly people', 'pre-frail elderly people']","['Elastic band exercise', 'elastic band exercise']","['frailty states', 'grip strength (female/male) and walking speed', 'frailty states, grip strength (female/male), walking speed, and physical activity', 'grip strength (male) and physical activity', 'frailty states, grip strength (female) and walking speed both']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0079377', 'cui_str': 'Frail Elders'}]","[{'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0243369,"The elastic band group showed significant improvements in the frailty states, grip strength (female) and walking speed both after 4-week and 8-week intervention (P< 0.001), and significant improvements in grip strength (male) and physical activity after 8-week intervention (P< 0.05).","[{'ForeName': 'Rujie', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Rehabilitation Department, North China University of Science and Technology , Tangshan, Hebei, China.'}, {'ForeName': 'Qingwen', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Rehabilitation Department, North China University of Science and Technology , Tangshan, Hebei, China.'}, {'ForeName': 'Dongyan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Rehabilitation Department, North China University of Science and Technology , Tangshan, Hebei, China.'}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'School of Public Health, Southern Medical University , Guangzhou, Guangdong, China.'}, {'ForeName': 'Howe', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Physical Therapy Department, University of North Texas Health Science Center , Fort Worth, TX, USA.'}, {'ForeName': 'Guangtian', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Rehabilitation Department, North China University of Science and Technology , Tangshan, Hebei, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Rehabilitation Department, North China University of Science and Technology , Tangshan, Hebei, China.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Rehabilitation Department, North China University of Science and Technology , Tangshan, Hebei, China.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1548673']
691,30714427,The effects of autologous platelet-rich plasma in repeated implantation failure: a randomized controlled trial.,"Repeated implantation failure is a major challenge in reproductive medicine and despite several methods that have been described for management, there is little consensus on which is the most effective. This study was conducted to evaluate the effectiveness of autologous platelet-rich plasma in improving the pregnancy rate in repeated implantation failure. Between 2016 and 2017, a total of 138 patients who failed to conceive after 3 or more embryo transfers with high quality embryos and candidate for frozen-thawed embryo transfer were assessed for eligibility to enter the study. Intrauterine infusion of 0.5 ml platelet-rich plasma (PRP) that contained platelets at 4-5 times higher concentration than peripheral blood was performed 48 h before blastocyst transfer. A control group received standard treatment. Ninety-seven patients completed the study procedure. There were no significant differences between the two groups in terms of age, body mass index and number of previous embryo transfers. The chemical pregnancy rate was higher in the PRP group than control group (53.06% versus 27.08%, respectively;  p  value: 0.009). Clinical pregnancy rate was higher in PRP group than control group (44.89% versus 16.66%, respectively;  p  value: 0.003). In conclusion, intrauterine platelet-rich plasma may be effective in the improvement of pregnancy outcome in repeated implantation failure.",2020,"There were no significant differences between the two groups in terms of age, body mass index and number of previous embryo transfers.","['Ninety-seven patients completed the study procedure', 'repeated implantation failure', 'Between 2016 and 2017, a total of 138 patients who failed to conceive after 3 or more embryo transfers with high quality embryos and candidate for frozen-thawed embryo transfer were assessed for eligibility to enter the study']","['autologous platelet-rich plasma', 'standard treatment', 'Intrauterine infusion of 0.5\u2009ml platelet-rich plasma (PRP']","['Clinical pregnancy rate', 'pregnancy rate', 'chemical pregnancy rate', 'age, body mass index and number of previous embryo transfers']","[{'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0677542', 'cui_str': 'Frozen (qualifier value)'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C2919902', 'cui_str': 'Chemical pregnancy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}]",138.0,0.113645,"There were no significant differences between the two groups in terms of age, body mass index and number of previous embryo transfers.","[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Nazari', 'Affiliation': 'Department of Obstetrics and Gynecology, Preventative Gynecology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saghar', 'Initials': 'S', 'LastName': 'Salehpour', 'Affiliation': 'Department of Obstetrics and Gynecology, Preventative Gynecology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam Sadat', 'Initials': 'MS', 'LastName': 'Hosseini', 'Affiliation': 'Department of Obstetrics and Gynecology, Preventative Gynecology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Hashemi Moghanjoughi', 'Affiliation': 'Department of Obstetrics and Gynecology, Preventative Gynecology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]","Human fertility (Cambridge, England)",['10.1080/14647273.2019.1569268']
692,31888977,Using Bluetooth beacon technology to reduce distracted pedestrian behaviour: a cross-over trial study protocol.,"OBJECTIVE


Over 6400 American pedestrians die annually, a figure that is currently increasing. One hypothesised reason for the increasing trend is the role of mobile technology in distracting both pedestrians and drivers. Scientists and policy-makers have attended somewhat to distracted driving, but attention to distracted pedestrian behaviour has lagged. We will evaluate Bluetooth beacon technology as a means to alert and warn pedestrians when they approach intersections, reminding them to attend to the traffic environment and cross streets safely.
METHODS


Bluetooth beacons are small devices that broadcast information unidirectionally within a closed proximal network. We will place beacons at an intersection frequently trafficked by urban college students. From there, the beacons will transmit to an app installed on users' smartphones, signalling users to attend to their environment and cross the street safely. A cross-over trial will evaluate the app with 411 adults who frequently cross the target intersection on an urban university campus. We will monitor those participants' behaviour over three distinct time periods: (1) 3 weeks without the app being activated, (2) 3 weeks with the app activated and (3) 4 weeks without the app activated to assess retention of behaviour. Throughout the 10-week period, we will gather information to evaluate whether the intervention changes distracted pedestrian behaviour using a logistic regression to estimate the likelihood of key behavioural outcome measures and adjusting for any residual confounding. We also will test for changes in perceived risk. The trial will follow CONSORT (Consolidated Standards of Reporting Trials) statement guidelines, as modified for cross-over design studies.
CONCLUSION


If this program proves successful, it offers exciting implications for future testing and ultimately for broad distribution to reduce distracted pedestrian behavior. We discuss issues of feasibility, acceptability and scalability.",2020,A cross-over trial will evaluate the app with 411 adults who frequently cross the target intersection on an urban university campus.,"['urban college students', '411 adults who frequently cross the target intersection on an urban university campus']",['Bluetooth beacon technology'],[],"[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}]",[],411.0,0.0541355,A cross-over trial will evaluate the app with 411 adults who frequently cross the target intersection on an urban university campus.,"[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Schwebel', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham, Birmingham, Alabama, USA schwebel@uab.edu.'}, {'ForeName': 'Ragib', 'Initials': 'R', 'LastName': 'Hasan', 'Affiliation': 'Department of Computer Science, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Griffin', 'Affiliation': 'Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}]",Injury prevention : journal of the International Society for Child and Adolescent Injury Prevention,['10.1136/injuryprev-2019-043436']
693,30714752,"Brief behavioral activation intervention for depressive symptoms: Patient satisfaction, acceptability, engagement, and treatment response.","Depressive symptoms are the most common reason for referral to integrated behavioral health providers in primary care. Although evidence-based brief psychotherapies for depression in primary care exist, treatment duration is a significant barrier to implementation. In this open trial, we examined the patient experience of receiving a brief behavioral activation intervention designed for use in primary care (BA-PC), which comprised 2 30-min appointments and 2 boosters spaced 2-3 weeks apart across 12 weeks, and its impact on depression symptoms. Participants were 22 patients recruited from primary care who reported at least moderate depressive symptoms (score ≥ 10 on the Patient Health Questionnaire-9 [PHQ-9]). Patient experiences were examined through assessing patient engagement, satisfaction, acceptability, and treatment response. Fidelity of intervention delivery in delivering the BA-PC within a 12-week period was also assessed. Participants reported a high level of satisfaction with and acceptability of the BA-PC intervention, materials, and format. Within-subject t tests revealed a significant reduction in depressive symptoms from baseline at the 12-week assessment, based on PHQ-9 total score,  t (21) = 3.80,  p  = .001. Evidence of fidelity included 81% of patients completing the 2 BA-PC appointments, average appointment lengths of approximately 30 min, and high content fidelity within each appointment. These preliminary findings suggest that overall experience of a brief BA-PC intervention was positive, with high patient satisfaction, patient acceptability, and treatment fidelity as well as positive patient treatment response. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2019,"Within-subject t tests revealed a significant reduction in depressive symptoms from baseline at the 12-week assessment, based on PHQ-9 total score,  t (21) =",['Participants were 22 patients recruited from primary care who reported at least moderate depressive symptoms (score ≥ 10 on the Patient Health Questionnaire-9'],"['behavioral activation intervention', 'Brief behavioral activation intervention']","['depressive symptoms', 'patient engagement, satisfaction, acceptability, and treatment response', 'Depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C3508152', 'cui_str': 'Patient Engagement'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",22.0,0.0933487,"Within-subject t tests revealed a significant reduction in depressive symptoms from baseline at the 12-week assessment, based on PHQ-9 total score,  t (21) =","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Funderburk', 'Affiliation': 'VA Center for Integrated Healthcare.'}, {'ForeName': 'Wilfred R', 'Initials': 'WR', 'LastName': 'Pigeon', 'Affiliation': 'VA VISN 2 Center of Excellence for Suicide Prevention.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Shepardson', 'Affiliation': 'VA Center for Integrated Healthcare.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Maisto', 'Affiliation': 'VA Center for Integrated Healthcare.'}]",Psychological services,['10.1037/ser0000328']
694,31691019,Ergogenic effects of caffeine on peak aerobic cycling power during the menstrual cycle.,"PURPOSE


Recent investigations have established that the ingestion of a moderate dose of caffeine (3-6 mg kg -1 ) can increase exercise and sports performance in women. However, it is unknown whether the ergogenicity of caffeine is similar during all phases of the menstrual cycle. The aim of this investigation was to determine the ergogenic effects of caffeine in three phases of the menstrual cycle.
METHODS


Thirteen well-trained eumenorrheic triathletes (age = 31 ± 6 years; body mass = 58.6 ± 7.8 kg) participated in a double-blind, cross-over, randomised experimental trial. In the (1) early follicular (EF); (2) preovulation (PO); (3) and mid luteal (ML) phases, participants either ingested a placebo (cellulose) or 3 mg kg -1  of caffeine in an opaque and unidentifiable capsule. After a 60-min wait for substance absorption, participants performed an incremental maximal cycle ergometer test until volitional fatigue (25 W/min) to assess peak aerobic cycling power (Wmax).
RESULTS


In comparison to the placebo, caffeine increased Wmax in the EF (4.13 ± 0.69 vs. 4.24 ± 0.71 W kg -1 , Δ = 2.7 ± 3.3%, P = 0.01), in the PO (4.14 ± 0.70 vs. 4.27 ± 0.73 W kg -1 , Δ = 3.3 ± 5.0%; P = 0.03) and in the ML (4.15 ± 0.69 vs. 4.29 ± 0.67 W kg -1 , Δ = 3.6 ± 5.1%; P = 0.01) phases. The magnitude of the caffeine ergogenic effect was similar during all of the menstrual cycle phases (P = 0.85).
CONCLUSION


Caffeine increased peak aerobic cycling power in the early follicular, preovulatory, and mid luteal phases. Thus, the ingestion of 3 mg of caffeine per kg of body mass might be considered an ergogenic aid for eumenorrheic women during all three phases of the menstrual cycle.",2020,"The magnitude of the caffeine ergogenic effect was similar during all of the menstrual cycle phases (P = 0.85).
","['Thirteen well-trained eumenorrheic triathletes (age\u2009=\u200931\u2009±\u20096\xa0years; body mass\u2009=\u200958.6\u2009±\u20097.8\xa0kg', 'women']","['Caffeine', 'placebo (cellulose) or 3\xa0mg\xa0kg -1  of caffeine', 'placebo, caffeine', 'caffeine']","['caffeine ergogenic effect', 'peak aerobic cycling power (Wmax', 'peak aerobic cycling power']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C3178747', 'cui_str': 'Ergogenic Effects'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]",13.0,0.222593,"The magnitude of the caffeine ergogenic effect was similar during all of the menstrual cycle phases (P = 0.85).
","[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Lara', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Gutiérrez-Hellín', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'García-Bataller', 'Affiliation': 'Faculty of Physical Activity and Sport Sciences, Universidad Politécnica de Madrid, Madrid, Spain.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Rodríguez-Fernández', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, Fuenlabrada, Spain.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Romero-Moraleda', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Del Coso', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, Fuenlabrada, Spain. juan.delcoso@urjc.es.'}]",European journal of nutrition,['10.1007/s00394-019-02100-7']
695,31691105,"A randomized, placebo-controlled trial using a novel PAP delivery platform to treat patients with OSA and comorbid PTSD.","PURPOSE


Positive airway pressure (PAP) adherence is poor in comorbid OSA/PTSD. SensAwake™ (SA) is a wake-sensing PAP algorithm that lowers pressure when wake is detected. We compared auto-PAP (aPAP) with and without SA for comorbid OSA/PTSD.
METHODS


Prospective, randomized crossover study comparing aPAP to aPAP + SA. We enrolled patients with OSA/PTSD who were PAP naïve. Four weeks after randomization, the patients were crossed over to the alternate treatment group, with final follow-up at eight weeks. Sleep questionnaires (ESS, ISI, FSS, and FOSQ-10) were assessed at baseline and follow-up.
RESULTS


We enrolled 85 patients with OSA/PTSD. aPAP reduced AHI to < 5/h in both groups. Our primary endpoint, average hours of aPAP adherence (total) after 4 weeks, was significantly increased in the SA group in our intention-to-treat (ITT) analysis (ß = 1.13 (95% CI 0.16-2.1); p = 0.02), after adjustment for ESS differences at baseline. After adjustment for ESS, SA (ITT analysis) also showed significant improvement in percentage of nights used for ≥ 4 h (ß = 14.9 (95% CI 1.02-28.9); p = 0.04). There were trends toward an increase in percentage nights used total (ß = 17.4 (95% CI - 0.1 to 34.9); p = 0.05), average hours of aPAP adherence (nights used) (ß = 1.04 (95% CI - 0.07 to 2.1); p = 0.07), and regular use (OR = 7.5 (95% CI 0.9-64.7); p = 0.07) after adjustment for ESS at baseline. After adjustment for ESS and days to cross over, SA by actual assignment did not show any effect on adherence variables. The ESS, ISI, FSS, and FOSQ-10 all showed significant improvements with PAP, but there were no differences in the magnitude of improvement in any score between groups.
CONCLUSIONS


Adherence to aPAP may be improved with the addition of SA and deserves further study. SA is as effective as standard aPAP for normalizing the AHI and improving sleep-related symptoms.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov NCT02549508 https://clinicaltrials.gov/ct2/show/NCT02549508?term=NCT02549508&rank=1 ""Comparison Study Using APAP With and Without SensAwake in Patients With OSA and PTSD"".",2020,"The ESS, ISI, FSS, and FOSQ-10 all showed significant improvements with PAP, but there were no differences in the magnitude of improvement in any score between groups.
","['85 patients with OSA/PTSD', 'enrolled patients with OSA/PTSD who were PAP naïve', 'Patients With OSA and PTSD', 'patients with OSA and comorbid PTSD']","['APAP', 'auto-PAP (aPAP) with and without SA', 'aPAP', 'SA', 'placebo', 'novel PAP delivery platform']","['Sleep questionnaires (ESS, ISI, FSS, and FOSQ-10', 'aPAP reduced AHI', 'average hours of aPAP adherence', 'percentage of nights used for ≥', 'Positive airway pressure (PAP) adherence', 'percentage nights used total', 'ESS, ISI, FSS, and FOSQ-10', 'average hours of aPAP adherence (total']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",85.0,0.105425,"The ESS, ISI, FSS, and FOSQ-10 all showed significant improvements with PAP, but there were no differences in the magnitude of improvement in any score between groups.
","[{'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Holley', 'Affiliation': 'Walter Reed National Military Medical Center, 8901 Wisconsin Avenue, Bethesda, MD, 20889, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shaha', 'Affiliation': 'Womack Army Medical Center, Fort Bragg, NC, USA.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Costan-Toth', 'Affiliation': 'Fort Belvoir Community Hospital, Fort Belvoir, VA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Slowik', 'Affiliation': 'Madigan Army Medical Center, Tacoma, WA, USA.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Robertson', 'Affiliation': 'Walter Reed National Military Medical Center, 8901 Wisconsin Avenue, Bethesda, MD, 20889, USA.'}, {'ForeName': 'Scott G', 'Initials': 'SG', 'LastName': 'Williams', 'Affiliation': 'Fort Belvoir Community Hospital, Fort Belvoir, VA, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Terry', 'Affiliation': 'Walter Reed National Military Medical Center, 8901 Wisconsin Avenue, Bethesda, MD, 20889, USA.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Golden', 'Affiliation': 'Walter Reed National Military Medical Center, 8901 Wisconsin Avenue, Bethesda, MD, 20889, USA.'}, {'ForeName': 'Teotimo', 'Initials': 'T', 'LastName': 'Andrada', 'Affiliation': 'Walter Reed National Military Medical Center, 8901 Wisconsin Avenue, Bethesda, MD, 20889, USA.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Skeete', 'Affiliation': 'Walter Reed National Military Medical Center, 8901 Wisconsin Avenue, Bethesda, MD, 20889, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sheikh', 'Affiliation': 'Walter Reed National Military Medical Center, 8901 Wisconsin Avenue, Bethesda, MD, 20889, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Butler', 'Affiliation': 'Walter Reed National Military Medical Center, 8901 Wisconsin Avenue, Bethesda, MD, 20889, USA.'}, {'ForeName': 'Jacob F', 'Initials': 'JF', 'LastName': 'Collen', 'Affiliation': 'Uniformed Services University of the Health Sciences, 4301 Jones Bridge Road, Bethesda, MD, 20814, USA. jacob.collen@usuhs.edu.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-019-01936-x']
696,30628511,Autologous transplantation as consolidation for high risk aggressive T-cell non-Hodgkin lymphoma: a SWOG 9704 intergroup trial subgroup analysis.,"Phase II data suggest a benefit to autotransplantation for aggressive T-cell non-Hodgkin lymphoma (T-NHL) in first remission; randomized trials have yet to validate this. We performed a retrospective analysis of aggressive T-NHL patients in the intergroup randomized consolidative autotransplant trial (SWOG 9704). Of the 370 enrolled, 40 had T-NHL: 12 were not randomized due to ineligibility ( n  = 1), choice ( n  = 2), or progression ( n  = 9), leaving 13 randomized to control and 15 to autologous stem cell transplantation (ASCT). Two ASCT patients refused transplant and one failed mobilization. The 5-year landmark PFS/OS estimates for ASCT vs. control groups were 40% vs. 38% ( p  = .56), and 40% vs. 45% ( p  = .98), respectively. No difference was seen based on IPI, or histologic subtype. Only 1/7 receiving BCNU-based therapy survived vs. 4/5 receiving TBI. Aggressive T-NHL autotransplanted in first remission did not appear to benefit from consolidative ASCT. This and the 30% who dropped out pre-randomization mostly to progression, suggests that improved induction regimens be developed.",2019,"The 5-year landmark PFS/OS estimates for ASCT vs. control groups were 40% vs. 38% (p = .56), and 40% vs. 45% (p = .98), respectively.","['370 enrolled, 40 had T-NHL: 12']","['control and 15 to autologous stem cell transplantation (ASCT', 'Autologous transplantation']","['IPI, or histologic subtype', '5-year landmark PFS/OS estimates']","[{'cui': 'C4517743', 'cui_str': 'Three hundred and seventy'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}]","[{'cui': 'C0668760', 'cui_str': ""P(1),P(5)-di(inosine-5')pentaphosphate""}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",2.0,0.103798,"The 5-year landmark PFS/OS estimates for ASCT vs. control groups were 40% vs. 38% (p = .56), and 40% vs. 45% (p = .98), respectively.","[{'ForeName': 'Zeina', 'Initials': 'Z', 'LastName': 'Al-Mansour', 'Affiliation': 'a Cardinal Bernardin Cancer Center, Loyola University Medical Center , Maywood , IL , USA.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'b SWOG Statistical Center , Seattle , WA , USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Cook', 'Affiliation': 'c Cleveland Clinic , Cleveland , OH , USA.'}, {'ForeName': 'Louis S', 'Initials': 'LS', 'LastName': 'Constine', 'Affiliation': 'd University of Rochester , Rochester , NY , USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Couban', 'Affiliation': 'e Queen Elizabeth II Health Sciences Centre and Dalhousie University , Halifax , Canada.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Stewart', 'Affiliation': 'f Tom Baker Cancer Centre, University of Calgary , Calgary , Canada.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Shea', 'Affiliation': 'g University of North Carolina , Chapel Hill , NC , USA.'}, {'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Porcu', 'Affiliation': 'h Sidney Kimmel Cancer Center, Thomas Jefferson University , Philadelphia , PA , USA.'}, {'ForeName': 'Jane N', 'Initials': 'JN', 'LastName': 'Winter', 'Affiliation': 'i Northwestern University , Chicago , IL , USA.'}, {'ForeName': 'Brad S', 'Initials': 'BS', 'LastName': 'Kahl', 'Affiliation': 'j University of Wisconsin , Madison , WI , USA.'}, {'ForeName': 'Sonali M', 'Initials': 'SM', 'LastName': 'Smith', 'Affiliation': 'k University of Chicago , Chicago , IL , USA.'}, {'ForeName': 'Deborah C', 'Initials': 'DC', 'LastName': 'Marcellus', 'Affiliation': 'l Juravinski Hospital and Cancer Centre , Hamilton , Canada.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Barton', 'Affiliation': 'a Cardinal Bernardin Cancer Center, Loyola University Medical Center , Maywood , IL , USA.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Mills', 'Affiliation': 'm Louisiana State University Health Sciences Center , Shreveport , LA , USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'LeBlanc', 'Affiliation': 'b SWOG Statistical Center , Seattle , WA , USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Rimsza', 'Affiliation': 'n Mayo Clinic , Scottsdale , AZ , USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Forman', 'Affiliation': 'o City of Hope Medical Center , Duarte , CA , USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Leonard', 'Affiliation': 'p Weill Cornell Medicine , New York , NY , USA.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Fisher', 'Affiliation': 'q q Temple University School of Medicine, Fox Chase Cancer Center - Temple Health , Philadelphia , PA , USA.'}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Friedberg', 'Affiliation': 'd University of Rochester , Rochester , NY , USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Stiff', 'Affiliation': 'a Cardinal Bernardin Cancer Center, Loyola University Medical Center , Maywood , IL , USA.'}]",Leukemia & lymphoma,['10.1080/10428194.2018.1563691']
697,32407835,An anti-IL-13 antibody reverses epithelial-mesenchymal transition biomarkers in eosinophilic esophagitis: Phase 2 trial results.,"BACKGROUND


Fibrostenosis, the most serious eosinophilic esophagitis (EoE) complication, is mediated by epithelial-mesenchymal transition (EMT). Transitioned cells contribute to pathogenesis by overproducing extracellular matrix.
OBJECTIVE


Our aim was to determine whether RPC4046 (anti‒IL-13 mAb) modulates EMT biomarkers in biopsy samples from adults with active EoE in a substudy of a double-blind, placebo-controlled phase 2 trial.
METHODS


Baseline and week 16 esophageal biopsy samples were taken from 69 patients who were randomized to weekly treatment with subcutaneous RPC4046, 180 mg (n = 19), 360 mg (n = 26), or placebo (n = 24). Duplex immunofluorescence slides stained for E-cadherin and vimentin were digitally analyzed by mapping each epithelial cell and recording fluorescence intensities. End points included change from baseline to week 16 in percentage of vimentin-positive epithelial cells (primary), total E-cadherin expression, and vimentin-to-E-cadherin ratio per cell (an average of 47,000 cells per biopsy sample analyzed).
RESULTS


The mean percentage of vimentin-positive cells decreased by 0.94%, 2.75%, and 4.24% in the placebo, low-dose, and high-dose groups, respectively (P =.032 for the high-dose vs placebo group). Mean E-cadherin expression per cell increased 5.6-fold in both dose groups versus in the placebo group (high-dose group P = .047). The increases in E-cadherin expression per cell from baseline to week 16 were correlated with improvements in histology, eosinophil counts, endoscopic findings, and symptoms.
CONCLUSION


RPC4046 significantly reduced EMT markers in adults with active EoE, with greater effects at 360 mg. Together with results for eosinophil density and clinical end points from the main trial, these data support the hypothesis that pharmacologic IL-13 inhibition ameliorates both inflammatory and remodeling pathways and could potentially reduce the risk of fibrostenotic complications.",2020,"Increases in e-cadherin per cell from baseline to week 16 were correlated with improvements in histology, eosinophil counts, endoscopic findings, and symptoms.
","['biopsies from adults with active EoE', 'eosinophilic esophagitis']","['subcutaneous RPC4046', 'RPC4046', 'RPC4046 (anti‒IL-13 monoclonal antibody', 'placebo']","['EMT markers', 'Mean e-cadherin expression per cell', 'percentage vimentin-positive epithelial cells (primary), total e-cadherin, and vimentin:e-cadherin ratio per cell (average of 47,000 cells/biopsy analyzed', 'histology, eosinophil counts, endoscopic findings, and symptoms', 'Mean percentage vimentin-positive cells']","[{'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0341106', 'cui_str': 'Eosinophilic esophagitis'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4547951', 'cui_str': 'RPC4046'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1523298', 'cui_str': 'Epithelial-Mesenchymal Transformation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042172', 'cui_str': 'E-Cadherin'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0042666', 'cui_str': 'Vimentin'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0014597', 'cui_str': 'Epithelial cell'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}]",69.0,0.430787,"Increases in e-cadherin per cell from baseline to week 16 were correlated with improvements in histology, eosinophil counts, endoscopic findings, and symptoms.
","[{'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Gann', 'Affiliation': 'Department of Pathology, University of Illinois College of Medicine, Chicago, Ill. Electronic address: pgann@uic.edu.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Deaton', 'Affiliation': 'Department of Pathology, University of Illinois College of Medicine, Chicago, Ill.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'McMahon', 'Affiliation': 'Department of Pathology, University of Illinois College of Medicine, Chicago, Ill.'}, {'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Collins', 'Affiliation': ""Division of Pathology and Laboratory Medicine, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'Evan S', 'Initials': 'ES', 'LastName': 'Dellon', 'Affiliation': 'Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Ikuo', 'Initials': 'I', 'LastName': 'Hirano', 'Affiliation': 'Northwestern University, Feinberg School of Medicine, Chicago, Ill.'}, {'ForeName': 'Steven Ye', 'Initials': 'SY', 'LastName': 'Hua', 'Affiliation': 'Celgene Corporation, Summit, NJ.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Rodriguez', 'Affiliation': 'Celgene Corporation, Summit, NJ.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'Celgene Corporation, Summit, NJ.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.03.045']
698,31602699,"Bovine-derived xenograft in combination with autogenous bone chips versus xenograft alone for the augmentation of bony dehiscences around oral implants: A randomized, controlled, split-mouth clinical trial.","AIM


The aim of the study was to evaluate whether the use of a xenograft is not inferior to the use of xenograft and autogenous bone chips in treating dehiscences at implant placement.
MATERIALS AND METHODS


After implant placement, leaving a dehiscence, control sites were treated using a composite graft (autogenous bone chips and xenograft) and at the test sites 100% xenograft was used. Both sites were covered with a resorbable collagen membrane. Dehiscences were measured clinically at implant placement and at re-entry. CBCT was taken immediately after implant placement and after 4 months.
RESULTS


In total, 28 GBR procedures were performed in 14 patients. On average, the change in vertical defect height was 2.07 mm (46.7%-test group) and 2.28 mm (50.9%-control group) (p > .05). The horizontal defect width at the implant shoulder change on average 1.85 mm (40.5%-test group) and 1.75 mm (40.9%-control group) (p > .05). On average, a loss in augmentation thickness of 0.45 mm (68.9%-test group) and 0.64 mm (55.5% control group) between implant placement and augmentation and abutment surgery was obtained at the implant shoulder.
CONCLUSION


Both treatment modalities seem to work to a certain extent. At implant shoulder level, the augmentation thickness seems to be disappeared after the healing phase. (NCT03946020).",2020,The horizontal defect width at the implant shoulder change on average 1.85mm (40.5% - test group) and 1.75mm (40.9% - control group) (p>0.05).,[],"['xenograft and autogenous bone chips', 'Bovine derived xenograft in combination with autogenous bone chips versus xenograft alone', 'CBCT']","['vertical defect height', 'augmentation thickness', 'Dehiscences', 'horizontal defect width']",[],"[{'cui': 'C0522537', 'cui_str': 'Xenografts'}, {'cui': 'C0443145', 'cui_str': 'Autogenous (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1510451', 'cui_str': 'Fries'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence (morphologic abnormality)'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}]",,0.0735622,The horizontal defect width at the implant shoulder change on average 1.85mm (40.5% - test group) and 1.75mm (40.9% - control group) (p>0.05).,"[{'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Temmerman', 'Affiliation': 'Section of Periodontology, Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Cortellini', 'Affiliation': 'Section of Periodontology, Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Van Dessel', 'Affiliation': 'OMFS-Impath Research Group, Department of Oral & Maxillofacial Surgery, KU Leuven & UZ University Hospitals, Leuven, Belgium.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'De Greef', 'Affiliation': 'Section of Periodontology, Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Reinhilde', 'Initials': 'R', 'LastName': 'Jacobs', 'Affiliation': 'OMFS-Impath Research Group, Department of Oral & Maxillofacial Surgery, KU Leuven & UZ University Hospitals, Leuven, Belgium.'}, {'ForeName': 'Rutger', 'Initials': 'R', 'LastName': 'Dhondt', 'Affiliation': 'Section of Periodontology, Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Teughels', 'Affiliation': 'Section of Periodontology, Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Quirynen', 'Affiliation': 'Section of Periodontology, Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals, KU Leuven, Leuven, Belgium.'}]",Journal of clinical periodontology,['10.1111/jcpe.13209']
699,30466334,Age Moderates the Effect of Self-Paced Exercise on Exercise Adherence among Overweight Adults.,"Objective:  The present study tested the hypothesis that the effect of self-paced exercise on adherence to exercise programs is more pronounced with increasing age.  Method:  Fifty-nine low-active overweight adults (18-65 years) were encouraged to walk 30 to 60 min/day and randomized to either self-paced ( n  = 30) or prescribed moderate-intensity ( n  = 29) conditions.  Results:  The effect of study condition was moderated by age (main effect:  b  = 6.14,  SE  = 2.54,  p  = .02; Condition × Age:  b  = -11.55,  SE  = 3.77,  p  < .01), such that among participants >50 years, those in the self-paced condition exercised 6 more min/day than participants in the prescribed moderate-intensity condition ( p  = .02), whereas among participants <50 years, those in the self-paced condition exercised 5.4 fewer min/day compared with those in the moderate-intensity condition ( p  = .05). Affective response to physical activity did not mediate the moderating effect of age.  Discussion:  As age increases, adults may be more likely to adhere to self-paced versus prescribed moderate-intensity exercise.",2020,"The effect of study condition was moderated by age (main effect: b = 6.14, SE = 2.54, p = .02; Condition × Age: b = -11.55, SE = 3.77, p < .01), such that","['Overweight Adults', 'Fifty-nine low-active overweight adults (18-65 years']","['Self-Paced Exercise', 'self-paced exercise']",['Exercise Adherence'],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0248716,"The effect of study condition was moderated by age (main effect: b = 6.14, SE = 2.54, p = .02; Condition × Age: b = -11.55, SE = 3.77, p < .01), such that","[{'ForeName': 'Harold H', 'Initials': 'HH', 'LastName': 'Lee', 'Affiliation': 'Brown University, Providence, RI, USA.'}, {'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Dunsiger', 'Affiliation': 'Brown University, Providence, RI, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Connell Bohlen', 'Affiliation': 'The University of Rhode Island, Kingston, USA.'}, {'ForeName': 'Holly K', 'Initials': 'HK', 'LastName': 'Boyle', 'Affiliation': 'Brown University, Providence, RI, USA.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Emerson', 'Affiliation': 'Brown University, Providence, RI, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Williams', 'Affiliation': 'Brown University, Providence, RI, USA.'}]",Journal of aging and health,['10.1177/0898264318812139']
700,30509746,Comparison of 3-month visual outcomes of a spherical and a toric trifocal intraocular lens.,"PURPOSE


To evaluate visual outcomes and satisfaction after implantation of 2 trifocal intraocular lenses (IOLs): a spherical IOL and a toric IOL.
SETTING


IOA Madrid Innova Ocular, Madrid, Spain.
DESIGN


Prospective, controlled clinical trial.
METHODS


Patients (>50 years) were implanted bilaterally with either a trifocal spherical hydrophilic IOL (FineVision POD F) if corneal astigmatism was 1.0 diopter (D) or less, or with a trifocal toric hydrophilic IOL (FineVision POD FT) if astigmatism was more than 1.0 D. Outcomes analyzed 3 months after surgery included monocular and binocular visual acuities at distance, near, and intermediate, both uncorrected and corrected. Defocus curves, contrast sensitivity, and patient satisfaction were also assessed.
RESULTS


There was no statistically significant difference between groups in monocular uncorrected distance (UDVA) (P = .38), monocular corrected distance (CDVA) (P = .22), or distance-corrected intermediate (DCIVA) (P = .95) visual acuities; however, the distance-corrected near visual acuity (DCNVA) was slightly better in the spherical IOL group (P = .008). The UDVA was 20/25 or better in 89% of eyes in the spherical IOL group and 93% in the toric IOL group. The DCIVA was 20/32 or better in 92% of eyes in the spherical IOL group and 93% in the toric IOL group at 80 cm (Radner Vissum chart), and 20/32 or better in 100% of eyes in both groups at 63 cm (Colenbrander chart). The DCNVA (Radner chart) was 20/32 or better in 89% of eyes in the spherical IOL group and 90% of eyes in the toric IOL group. There was no difference between the groups in contrast sensitivity, defocus curves, cylinder, or satisfaction results.
CONCLUSION


Patients had significant improvement in visual acuity and gained functional uncorrected visual acuity across all distances in both groups. Satisfaction was high with both IOLs.",2019,"There was no statistically significant difference between groups in monocular uncorrected distance (UDVA) (P = .38), monocular corrected distance (CDVA) (P = .22), or distance-corrected intermediate (DCIVA)","['IOA Madrid Innova Ocular, Madrid, Spain', 'Patients (>50\xa0years']","['trifocal spherical hydrophilic IOL (FineVision POD F) if corneal astigmatism was 1.0 diopter (D) or less, or with a trifocal toric hydrophilic IOL (FineVision POD FT) if astigmatism was', 'spherical and a toric trifocal intraocular lens', '2 trifocal intraocular lenses (IOLs']","['DCIVA', 'visual acuity and gained functional uncorrected visual acuity', 'contrast sensitivity, defocus curves, cylinder, or satisfaction results', 'Satisfaction', 'distance-corrected near visual acuity (DCNVA', 'monocular corrected distance (CDVA', 'monocular uncorrected distance (UDVA', 'UDVA', 'distance-corrected intermediate (DCIVA', 'Defocus curves, contrast sensitivity, and patient satisfaction', 'monocular and binocular visual acuities at distance, near, and intermediate, both uncorrected and corrected']","[{'cui': 'C0648637', 'cui_str': 'IOA'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1275646', 'cui_str': 'Trifocals'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0475370', 'cui_str': 'Hydrophilicity'}, {'cui': 'C0339682', 'cui_str': 'Corneal astigmatism'}, {'cui': 'C0439486', 'cui_str': 'Diopters - (qualifier value)'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}]","[{'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1637380', 'cui_str': 'Uncorrected visual acuity'}, {'cui': 'C0009928', 'cui_str': 'Visual Contrast Sensitivity'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C4319645', 'cui_str': 'Cylinder (unit of presentation)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity (observable entity)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}]",,0.0511999,"There was no statistically significant difference between groups in monocular uncorrected distance (UDVA) (P = .38), monocular corrected distance (CDVA) (P = .22), or distance-corrected intermediate (DCIVA)","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Poyales', 'Affiliation': 'IOA Madrid Innova Ocular, Madrid, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Garzon', 'Affiliation': 'IOA Madrid Innova Ocular, Madrid, Spain. Electronic address: ngarzon@ioamadrid.com.'}]",Journal of cataract and refractive surgery,['10.1016/j.jcrs.2018.09.025']
701,30709627,Effect of a patient-information video on the preoperative anxiety levels of cataract surgery patients.,"PURPOSE


To assess whether a cataract surgery patient-information video reduces patients' preoperative anxiety levels.
SETTING


Leeds Teaching Hospitals NHS Trust, UK.
DESIGN


Prospective controlled trial of an intervention to reduce anxiety for first-eye elective cataract surgery patients.
METHODS


Patients attending for first-eye elective cataract surgery were included in the study. The primary outcome measure was a questionnaire based upon the Amsterdam Preoperative Anxiety and Information Score (APAIS), and an 80.0 mm visual analogue scale (VAS) score. The questionnaire was administered to a control group of consecutive preoperative cataract surgery patients who had not seen the information video. Subsequently, the video was introduced to the surgical pathway and the questionnaire was administered preoperatively to an intervention group of consecutive patients who had watched the video.
RESULTS


The study comprised 200 patients (100 in the intervention group, 100 in the control group). There was a significant difference in mean VAS anxiety scores between the control group (45.5 mm ± 21.4 [SD]) and the intervention group (11.2 ± 11.4 mm) (P < .001). On a 5-stage Likert scale, responses to the APAIS statement ""I am worried about the procedure"" (range 1 = not at all to 5 = extremely worried) also showed that the control group patients were significantly more worried than the intervention group (P < .001). The mode response score was 3 in the control group versus 1 in the intervention group.
CONCLUSIONS


Providing a patient-information video before cataract surgery was an inexpensive and effective intervention in reducing preoperative anxiety. Such interventions could improve the overall experience of cataract surgery patients.",2019,There was a significant difference in mean VAS anxiety scores between the control group (45.5 mm ± 21.4 [SD]) and the intervention group (11.2 ± 11.4 mm) (P ,"['200 patients (100 in the intervention group, 100 in the control group', 'Patients attending for first-eye elective cataract surgery were included in the study', 'cataract surgery patients', 'Leeds Teaching Hospitals NHS Trust, UK', 'first-eye elective cataract surgery patients']","['consecutive preoperative cataract surgery patients who had not seen the information video', 'patient-information video', 'cataract surgery patient-information video']","['mean VAS anxiety scores', 'preoperative anxiety levels', 'questionnaire based upon the Amsterdam Preoperative Anxiety and Information Score (APAIS), and an 80.0\xa0mm visual analogue scale (VAS) score', 'preoperative anxiety', 'anxiety']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0237935', 'cui_str': 'Trust'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332252', 'cui_str': 'Not seen (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",200.0,0.0455525,There was a significant difference in mean VAS anxiety scores between the control group (45.5 mm ± 21.4 [SD]) and the intervention group (11.2 ± 11.4 mm) (P ,"[{'ForeName': 'Kiran J', 'Initials': 'KJ', 'LastName': 'Ahmed', 'Affiliation': 'Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom. Electronic address: kiranjahmed@gmail.com.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Pilling', 'Affiliation': 'Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom.'}, {'ForeName': 'Khuram', 'Initials': 'K', 'LastName': 'Ahmed', 'Affiliation': 'Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Buchan', 'Affiliation': 'Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom.'}]",Journal of cataract and refractive surgery,['10.1016/j.jcrs.2018.11.011']
702,32407710,"The effect of lactoferrin supplementation on death or major morbidity in very low birthweight infants (LIFT): a multicentre, double-blind, randomised controlled trial.","BACKGROUND


Very low birthweight or preterm infants are at increased risk of adverse outcomes including sepsis, necrotising enterocolitis, and death. We assessed whether supplementing the enteral diet of very low-birthweight infants with lactoferrin, an antimicrobial protein, reduces all-cause mortality or major morbidity.
METHODS


We did a multicentre, double-blind, pragmatic, randomised superiority trial in 14 Australian and two New Zealand neonatal intensive care units. Infants born weighing less than 1500 g and aged less than 8 days, were eligible and randomly assigned (1:1) using minimising web-based randomisation to receive once daily 200 mg/kg pasteurised bovine lactoferrin supplements or no lactoferrin supplement added to breast or formula milk until 34 weeks' post-menstrual age (or for 2 weeks, if longer), or until discharge from the study hospital if that occurred first. Designated nurses preparing the daily feeds were not masked to group assignment, but other nurses, doctors, parents, caregivers, and investigators were unaware. The primary outcome was survival to hospital discharge or major morbidity (defined as brain injury, necrotising enterocolitis, late-onset sepsis at 36 weeks' post-menstrual age, or retinopathy treated before discharge) assessed in the intention-to-treat population. Safety analyses were by treatment received. We also did a prespecified, PRISMA-compliant meta-analysis, which included this study and other relevant randomised controlled trials, to estimate more precisely the effects of lactoferrin supplementation on late-onset sepsis, necrotising enterocolitis, and survival. This trial is registered with the Australian and New Zealand Clinical Trials Registry, ACTRN12611000247976.
FINDINGS


Between June 27, 2014, and Sept 1, 2017, we recruited 1542 infants; 771 were assigned to the intervention group and 771 to the control group. One infant who had consent withdrawn before beginning lactoferrin treatment was excluded from analysis. In-hospital death or major morbidity occurred in 162 (21%) of 770 infants in the intervention group and in 170 (22%) of 771 infants in the control group (relative risk [RR] 0·95, 95% CI 0·79-1·14; p=0·60). Three suspected unexpected serious adverse reactions occurred; two in the lactoferrin group, namely unexplained late jaundice and inspissated milk syndrome, but were not attributed to the intervention and one in the control group had fatal inspissated milk syndrome. Our meta-analysis identified 13 trials completed before Feb 18, 2020, including this Article, in 5609 preterm infants. Lactoferrin supplements significantly reduced late-onset sepsis (RR 0·79, 95% CI 0·71-0·88; p<0·0001; I 2 =58%), but not necrotising enterocolitis or all-cause mortality.
INTERPRETATION


Lactoferrin supplementation did not improve death or major morbidity in this trial, but might reduce late-onset sepsis, as found in our meta-analysis of over 5000 infants. Future collaborative studies should use products with demonstrated biological activity, be large enough to detect moderate and clinically important effects reliably, and assess greater doses of lactoferrin in infants at increased risk, such as those not exclusively receiving breastmilk or infants of extremely low birthweight.
FUNDING


Australian National Health and Medical Research Council.",2020,"Lactoferrin supplements significantly reduced late-onset sepsis (RR 0·79, 95% CI 0·71-0·88; p<0·0001; I 2 =58%), but not necrotising enterocolitis or all-cause mortality.
INTERPRETATION


Lactoferrin supplementation did not improve death or major morbidity in this trial, but might reduce late-onset sepsis, as found in our meta-analysis of over 5000 infants.","['Infants born weighing less than 1500 g and aged less than 8 days, were eligible and randomly assigned (1:1) using', '14 Australian and two New Zealand neonatal intensive care units', '5609 preterm infants', 'One infant who had consent withdrawn before beginning lactoferrin treatment was excluded from analysis', '1542 infants; 771 were assigned to the intervention group and 771 to the control group', 'very low birthweight infants (LIFT', 'Between June 27, 2014, and Sept 1, 2017']","['Lactoferrin supplements', 'lactoferrin supplementation', 'lactoferrin', ""minimising web-based randomisation to receive once daily 200 mg/kg pasteurised bovine lactoferrin supplements or no lactoferrin supplement added to breast or formula milk until 34 weeks' post-menstrual age""]","['death or major morbidity', 'hospital death or major morbidity', 'fatal inspissated milk syndrome', 'unexplained late jaundice and inspissated milk syndrome', ""survival to hospital discharge or major morbidity (defined as brain injury, necrotising enterocolitis, late-onset sepsis at 36 weeks' post-menstrual age, or retinopathy treated before discharge) assessed in the intention-to-treat population"", 'late-onset sepsis', 'late-onset sepsis, necrotising enterocolitis, and survival']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}]","[{'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C1440867', 'cui_str': 'Bovine lactoferrin'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0452742', 'cui_str': 'Formula milk'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0277608', 'cui_str': 'Death in hospital'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0022346', 'cui_str': 'Jaundice'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035309', 'cui_str': 'Retinal disorder'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",5609.0,0.688179,"Lactoferrin supplements significantly reduced late-onset sepsis (RR 0·79, 95% CI 0·71-0·88; p<0·0001; I 2 =58%), but not necrotising enterocolitis or all-cause mortality.
INTERPRETATION


Lactoferrin supplementation did not improve death or major morbidity in this trial, but might reduce late-onset sepsis, as found in our meta-analysis of over 5000 infants.","[{'ForeName': 'William O', 'Initials': 'WO', 'LastName': 'Tarnow-Mordi', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia. Electronic address: william.tarnow-mordi@ctc.usyd.edu.au.'}, {'ForeName': 'Mohamed E', 'Initials': 'ME', 'LastName': 'Abdel-Latif', 'Affiliation': 'Australian National University, Canberra, ACT, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Pammi', 'Affiliation': 'Texas Medical Centre, Houston, TX, USA.'}, {'ForeName': 'Kristy', 'Initials': 'K', 'LastName': 'Robledo', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Manzoni', 'Affiliation': 'Nuovo Ospedale Degli Infermi, Ponderano, Italy.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Osborn', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Lui', 'Affiliation': 'University of New South Wales, Kensington, NSW, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Keech', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hague', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Alpana', 'Initials': 'A', 'LastName': 'Ghadge', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Javeed', 'Initials': 'J', 'LastName': 'Travadi', 'Affiliation': 'University of Newcastle, Newcastle, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Darlow', 'Affiliation': 'University of Otago, Otago, New Zealand.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Liley', 'Affiliation': 'University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Margo', 'Initials': 'M', 'LastName': 'Pritchard', 'Affiliation': 'University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Kochar', 'Affiliation': 'University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Isaacs', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Gordon', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Askie', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Cruz', 'Affiliation': 'Miracle Babies Foundation, Chipping Norton, NSW, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Schindler', 'Affiliation': 'University of New South Wales, Kensington, NSW, Australia.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Dixon', 'Affiliation': 'University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Girish', 'Initials': 'G', 'LastName': 'Deshpande', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tracy', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Schofield', 'Affiliation': 'Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Austin', 'Affiliation': 'University of Otago, Otago, New Zealand.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sinn', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'R John', 'Initials': 'RJ', 'LastName': 'Simes', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(20)30093-6']
703,30691922,Safety and efficacy of intracameral moxifloxacin for prevention of post-cataract endophthalmitis: Randomized controlled clinical trial.,"PURPOSE


To evaluate the safety and efficacy of intracameral (IC) 0.5% moxifloxacin in the prevention of post-cataract endophthalmitis.
SETTING


University of Campinas, São Paulo, Brazil.
DESIGN


Prospective randomized partially masked single-site clinical trial.
METHODS


Patients who had phacoemulsification were randomized into two groups in block sizes of 4. Group A (moxifloxacin group) consisted of patients who received an IC injection of 0.03 mL (150 μg) of undiluted 0.5% moxifloxacin at the end of surgery. Group B (control group) consisted of patients who received no IC medication. The postoperative prescription for both groups consisted of 0.5% moxifloxacin and 0.1% dexamethasone. Patients were monitored for 6 weeks after surgery. The primary outcome was the incidence of acute endophthalmitis in each group. Secondary outcomes were corrected distance visual acuity (CDVA), endothelial cell density (ECD), intraocular pressure (IOP), and central corneal thickness (CCT).
RESULTS


The study comprised 3640 eyes from 3640 patients. There were 1818 patients in Group A and 1822 patients in Group B. The incidence of endophthalmitis within 6 weeks of follow-up was 1 (0.05%) of 1818 eyes in the moxifloxacin group and 7 (0.38%) of 1822 eyes in the control group (P = .035). There was no significant difference in CDVA (P = .202), ECD (P = .482), IOP (P = .105), or CCT (P = .558). No ocular or systemic study-related adverse events were observed.
CONCLUSIONS


The IC injection of undiluted 0.5% moxifloxacin can be safely applied as the last step of phacoemulsification. It was found to be effective in reducing the risk for endophthalmitis. This study represents the first controlled randomized clinical trial to evaluate the safety and efficacy of IC moxifloxacin in the prevention of post-cataract endophthalmitis.",2019,"There was no significant difference in CDVA (P = .202), ECD (P = .482), IOP (P = .105), or CCT (P = .558).","['1818 patients in Group A and 1822 patients in Group B', '3640 eyes from 3640 patients', 'post-cataract endophthalmitis', 'University of Campinas, São Paulo, Brazil', 'Patients who had phacoemulsification']","['IC moxifloxacin', 'no IC medication', 'intracameral moxifloxacin', 'moxifloxacin', 'IC injection of\xa00.03\xa0mL (150\xa0μg) of undiluted 0.5% moxifloxacin', 'intracameral (IC)\xa00.5% moxifloxacin', 'dexamethasone']","['ocular or systemic study-related adverse events', 'safety and efficacy', 'CDVA', 'incidence of acute endophthalmitis', 'risk for endophthalmitis', 'IOP', 'corrected distance visual acuity (CDVA), endothelial cell density (ECD), intraocular pressure (IOP), and central corneal thickness (CCT', 'postoperative prescription', 'incidence of endophthalmitis', 'Safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0014236', 'cui_str': 'Ophthalmia'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}]","[{'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C4517402', 'cui_str': '0.03 (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0154773', 'cui_str': 'Acute endophthalmitis (disorder)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0014236', 'cui_str': 'Ophthalmia'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell count'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]",3640.0,0.0911041,"There was no significant difference in CDVA (P = .202), ECD (P = .482), IOP (P = .105), or CCT (P = .558).","[{'ForeName': 'Mathias V', 'Initials': 'MV', 'LastName': 'Melega', 'Affiliation': 'School of Medical Sciences, University of Campinas, São Paulo, Brazil. Electronic address: mvmelega@hotmail.com.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Alves', 'Affiliation': 'School of Medical Sciences, University of Campinas, São Paulo, Brazil.'}, {'ForeName': 'Rodrigo Pessoa', 'Initials': 'RP', 'LastName': 'Cavalcanti Lira', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Iuri', 'Initials': 'I', 'LastName': 'Cardoso da Silva', 'Affiliation': 'School of Medical Sciences, University of Campinas, São Paulo, Brazil.'}, {'ForeName': 'Bruna Gil', 'Initials': 'BG', 'LastName': 'Ferreira', 'Affiliation': 'School of Medical Sciences, University of Campinas, São Paulo, Brazil.'}, {'ForeName': 'Hermano Lg', 'Initials': 'HL', 'LastName': 'Assis Filho', 'Affiliation': 'School of Medical Sciences, University of Campinas, São Paulo, Brazil.'}, {'ForeName': 'Fernando Rodrigo', 'Initials': 'FR', 'LastName': 'Pedreira Chaves', 'Affiliation': 'School of Medical Sciences, University of Campinas, São Paulo, Brazil.'}, {'ForeName': 'Alexandre A F', 'Initials': 'AAF', 'LastName': 'Martini', 'Affiliation': 'School of Medical Sciences, University of Campinas, São Paulo, Brazil.'}, {'ForeName': 'Livia Maria', 'Initials': 'LM', 'LastName': 'Dias Freire', 'Affiliation': 'School of Medical Sciences, University of Campinas, São Paulo, Brazil.'}, {'ForeName': 'Roberto Dos', 'Initials': 'RD', 'LastName': 'Reis', 'Affiliation': 'School of Medical Sciences, University of Campinas, São Paulo, Brazil.'}, {'ForeName': 'Carlos Eduardo', 'Initials': 'CE', 'LastName': 'Leite Arieta', 'Affiliation': 'School of Medical Sciences, University of Campinas, São Paulo, Brazil.'}]",Journal of cataract and refractive surgery,['10.1016/j.jcrs.2018.10.044']
704,30696306,A comparative study on the efficacy of nifedipine and indomethacin for prevention of preterm birth as monotherapy and combination therapy: a randomized clinical trial.,"Introduction:  Preterm delivery is an important issue in obstetrics, which is the most common cause of neonatal mortality and morbidity. Therefore, finding a way to prevent it is always under serious concern. Objective:  The study aimed to compare the efficacy of two tocolytic agents, nifedipine and indomethacin, for inhibiting preterm uterine contractions as monotherapy and combination therapy. Materials and methods:  A double-blind randomized clinical trial was performed on pregnant women with gestational age of 26-34 weeks of pregnancy who referred to hospital for preterm labor. They were randomly assigned to three groups. Indomethacin plus placebo, nifedipine plus placebo, and a combination of indomethacin and nifedipine were administered to the three groups. Inhibiting contractions for 2 hours and prevention of delivery for 48 hours and 7 days were evaluated. Also, duration of pregnancy, the number of preterm births, and the interval between entering the study and delivery were compared between three groups. Results:  One hundred fifty women were eligible for the study. Two women in the nifedipine group and one woman in the combined group were excluded from the study because of hypotension. The women of the three groups did not have significant difference according to age, BMI, gravidity, parity, Bishop score, gestational age, and the number of contractions at entering the study. Thirty-six women (72%) in the indomethacin group, 36 women (72%) in the nifedipine group, and 41 women (89.4%) in the combination group had stopped contractions within the first 2 hours of intervention ( p  = .002). Inhibiting contractions for 48 hours ( p  = .003), inhibiting contractions for 7 days ( p  = .021), gestational age at birth ( p  = .001), number of pregnancies more than 37 weeks ( p  = .007), and neonatal weight ( p  = .020) were significantly more in the combination group. Conclusion:  Combination therapy with nifedipine and indomethacin was more effective than monotherapy with either of these two medications for inhibiting preterm labor, delaying delivery, and prolongation of the duration of pregnancy.",2020,"Inhibiting contractions for 48 hours (p = .003), inhibiting contractions for 7 days (p = .021), gestational age at birth (p = .001), number of pregnancies more than 37 weeks (p = .007), and neonatal weight (p = .020) were significantly more in the combination group.
","['pregnant women with gestational age of 26-34\xa0weeks of pregnancy who referred to hospital for preterm labor', 'One hundred fifty women were eligible for the study']","['monotherapy and combination therapy', 'indomethacin and nifedipine', 'nifedipine', 'Indomethacin plus placebo, nifedipine plus placebo', 'nifedipine and indomethacin', 'indomethacin']","['stopped contractions', 'Inhibiting contractions', 'number of pregnancies', 'inhibiting preterm labor, delaying delivery, and prolongation of the duration of pregnancy', 'hypotension', 'neonatal weight', 'gestational age at birth', 'inhibiting contractions', 'duration of pregnancy, the number of preterm births']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0019982', 'cui_str': 'Hospital Referral'}, {'cui': 'C0022876', 'cui_str': 'Preterm Labor'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0600457', 'cui_str': 'Gravidity'}, {'cui': 'C0022876', 'cui_str': 'Preterm Labor'}, {'cui': 'C0235863', 'cui_str': 'Delayed delivery'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0456129', 'cui_str': 'Length of gestation at birth'}, {'cui': 'C2585667', 'cui_str': 'Number of preterm deliveries'}]",150.0,0.192127,"Inhibiting contractions for 48 hours (p = .003), inhibiting contractions for 7 days (p = .021), gestational age at birth (p = .001), number of pregnancies more than 37 weeks (p = .007), and neonatal weight (p = .020) were significantly more in the combination group.
","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kashanian', 'Affiliation': 'Department of Obstetrics and Gynecology, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shaghayegh', 'Initials': 'S', 'LastName': 'Shirvani', 'Affiliation': 'Department of Obstetrics and Gynecology, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Sheikhansari', 'Affiliation': 'Faculty of Medicine, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Forough', 'Initials': 'F', 'LastName': 'Javanmanesh', 'Affiliation': 'Department of Obstetrics and Gynecology, Iran University of Medical Sciences, Tehran, Iran.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1570117']
705,30690550,The reach and effectiveness of SIPsmartER when implemented by rural public health departments: a pilot dissemination and implementation trial to reduce sugar-sweetened beverages.,"SIPsmartER is a theory-based, 6-month, multi-component health literacy intervention shown to improve sugar-sweetened beverages (SSB) behaviors among adults in rural, southwest Virginia. The objective of this pilot trial was to understand the reach and effectiveness of SIPsmartER when delivered by existing staff in public health practice settings. This pre-post research design was conducted in partnership with four medically underserved southwest Virginia Department of Health (VDH) districts. Validated measures and standardized data collection techniques were used. Analyses included descriptive statistics and multilevel mixed-effects linear regressions models. Of 928 individuals screened, 586 (63%) were eligible and 117 (20% of eligible) enrolled in SIPsmartER (79% retained). The sample was majority female (71%) and white (94%) and had ≤high school education (59%) and an annual income of approximately $12,500. Relative to the county population, the enrolled study sample was representative for age and race, yet underrepresented for men and overrepresented for low income and low educational attainment. Significant improvements from baseline to 6 months were observed for the primary SSB outcome (-403 [confidence interval [CI] = -528, -278] SSB kcals/day) (p < .001). SSB-related attitudes, perceived behavioral control, behavioral intentions, and media literacy also significantly improved (all p < .05). SIPsmartER appears to be promising for VDH and potentially other health departments in medically underserved areas. When compared to the previous effectiveness trial, existing VDH staff achieved similar reach and effectiveness for some, but not all, outcomes. Future work is needed on methods to support health departments in developing strategies to reach new participants and to integrate SIPsmartER into sustained practice.",2020,"When compared to the previous effectiveness trial, existing VDH staff achieved similar reach and effectiveness for some, but not all, outcomes.","['rural public health departments', 'The sample was majority female (71%) and white (94%) and had ≤high school education (59%) and an annual income of approximately $12,500', 'partnership with four medically underserved southwest Virginia Department of Health (VDH) districts', 'Of 928 individuals screened, 586 (63%) were eligible and 117 (20% of eligible) enrolled in SIPsmartER (79% retained', 'county population, the enrolled study sample was representative for age and race, yet underrepresented for men and overrepresented for low income and low educational attainment', 'adults in rural, southwest Virginia', 'public health practice settings']",[],"['SSB-related attitudes, perceived behavioral control, behavioral intentions, and media literacy']","[{'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0042753', 'cui_str': 'Virginia'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0034024', 'cui_str': 'Public Health Practice'}]",[],"[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}]",,0.066299,"When compared to the previous effectiveness trial, existing VDH staff achieved similar reach and effectiveness for some, but not all, outcomes.","[{'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Zoellner', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Christiansburg, VA, USA.'}, {'ForeName': 'Kathleen J', 'Initials': 'KJ', 'LastName': 'Porter', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Christiansburg, VA, USA.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'You', 'Affiliation': 'Department of Agricultural and Applied Economics, Virginia Tech, Blacksburg, VA, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Estabrooks', 'Affiliation': 'Department of Health Promotion, Social and Behavioral Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Katelynn', 'Initials': 'K', 'LastName': 'Perzynski', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Christiansburg, VA, USA.'}, {'ForeName': 'Pamela A', 'Initials': 'PA', 'LastName': 'Ray', 'Affiliation': 'New River Health District, Virginia Department of Health, Christiansburg, VA, USA.'}, {'ForeName': 'Eleanor S', 'Initials': 'ES', 'LastName': 'Cantrell', 'Affiliation': 'LENOWISCO and Cumberland Plateau Health District, Virginia Department of Health, Wise, VA, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibz003']
706,31684758,Low-Intensity Exercise Training Increases Heart Rate Variability in Patients With Peripheral Artery Disease.,"Patients with peripheral artery disease (PAD), consistent with others with atherosclerotic occlusive disorders, have autonomic dysfunction (as measured by low heart rate variability [HRV]) that predisposes them to sympathetically mediated cardiac arrhythmias and sudden death. Exercise therapy has been shown to increase HRV in patients with coronary artery disease by increasing parasympathetic modulation of heart rate. This study quantified the circulatory and autonomic effects of a progressive, 12-week home-based, low-intensity (pain-free walking) exercise program in PAD and intermittent claudication. Participants ( N  = 33, mean age 67.8 8.1 years) were randomly assigned to either a walking group ( n  = 18), whose members performed a structured, 12-week, progressive walking program 5 days/week for 12 weeks, or a comparison group ( n  = 15), whose members performed usual activities. Circulatory measures (heart rate, blood pressure, and rate pressure product) and autonomic measures (HRV) were obtained at the beginning (Week 1) and end (Week 12) of the study. Minimal change in circulatory measures occurred. However, spectral analysis of HRV revealed that autonomic function improved significantly in members of the walking group; specifically, there was an increase in parasympathetic and a decrease in sympathetic modulation. Members of the walking group also significantly increased maximal walking distance. These findings suggest that a structured, low-intensity, high-frequency walking program improves autonomic function by increasing HRV in patients with PAD.",2020,Exercise therapy has been shown to increase HRV in patients with coronary artery disease by increasing parasympathetic modulation of heart rate.,"['patients with coronary artery disease', 'Patients with peripheral artery disease (PAD', 'Patients With Peripheral Artery Disease', 'patients with PAD', 'Participants ( N  = 33, mean age 67.8 8.1 years', 'PAD and intermittent claudication']","['Exercise therapy', 'low-intensity (pain-free walking) exercise program', 'Low-Intensity Exercise Training']","['autonomic function', 'Circulatory measures (heart rate, blood pressure, and rate pressure product) and autonomic measures (HRV', 'maximal walking distance', 'autonomic dysfunction', 'circulatory measures', 'parasympathetic', 'sympathetic modulation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517875', 'cui_str': '8.1 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021775', 'cui_str': 'Intermittent Claudication'}]","[{'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C1145628', 'cui_str': 'Central Autonomic Nervous System Diseases'}]",,0.0142566,Exercise therapy has been shown to increase HRV in patients with coronary artery disease by increasing parasympathetic modulation of heart rate.,"[{'ForeName': 'Ingrid K M', 'Initials': 'IKM', 'LastName': 'Brenner', 'Affiliation': ""School of Nursing, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'C Ann', 'Initials': 'CA', 'LastName': 'Brown', 'Affiliation': 'Deceased.'}, {'ForeName': 'Sylvia J M', 'Initials': 'SJM', 'LastName': 'Hains', 'Affiliation': ""School of Nursing, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Tranmer', 'Affiliation': ""School of Nursing, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Zelt', 'Affiliation': 'Division of Vascular Surgery, Queens University, Kingston, Ontario, Canada.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Brown', 'Affiliation': 'Division of Vascular Surgery, Queens University, Kingston, Ontario, Canada.'}]",Biological research for nursing,['10.1177/1099800419884642']
707,32408253,Effect of amino acids on IGF1 gene expression in human myotubes and skeletal muscle.,"OBJECTIVE


Insulin-like growth factor I (IGF1) is an important regulator of collagen and extracellular matrix protein expression. We aimed to evaluate the effect of amino acids (AAs) on expression of IGF1 and IGF1-dependent genes in human myotubes and skeletal muscle and supposed that AAs administration increases IGF1 levels in blood and expression of IGF1 and IGF1-dependent genes in trained skeletal muscle, thereby reducing training-induced muscle damage.
DESIGN


Human myotubes were incubated with Arg and Leu for 24 h. Then, the effects of long-term branched chain AAs administration (10 weeks, 0.1 g/kg body mass/day) to volunteers (six subjects per AAs and placebo groups) performing large training volumes regularly (cross country skiers, training twice a day) were examined.
RESULTS


Incubating the myotubes with AAs increases expression of IGF1 mRNA isoforms and IGF1 secretion by 2-3 times. In athletes, long-term AAs administration increased basal blood levels of IGF1 (~50%) and expression of IGF1Ea mRNA slightly in skeletal muscle. There is no marked increase in expression of COL1A1, COL3A1, COL5A1, and LOX genes in skeletal muscle after AAs administration. However, expression of these genes in the combined group (placebo + AAs; n = 12) significantly correlated with the expression of IGF1Ea mRNA in muscle and did not correlate with IGF1 levels in the blood.
CONCLUSIONS


AAs administration increases IGF1 expression in vitro and in vivo. To obtain more pronounced changes in expression of IGF1 and IGF1-dependent genes in skeletal muscle, it may be necessary to increase the dose and/or duration of AAs administration.",2020,"There is no marked increase in expression of COL1A1, COL3A1, COL5A1, and LOX genes in skeletal muscle after AAs administration.","['human myotubes and skeletal muscle', 'Human myotubes were incubated with Arg and Leu for 24\xa0h']","['Insulin-like growth factor', 'amino acids', 'amino acids (AAs']","['IGF1 gene expression', 'IGF1 expression', 'basal blood levels of IGF1', 'expression of IGF1 mRNA isoforms and IGF1 secretion', 'expression of IGF1Ea mRNA', 'expression of COL1A1, COL3A1, COL5A1, and LOX genes in skeletal muscle', 'IGF1 levels']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1704336', 'cui_str': 'Skeletal muscle fiber'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}]","[{'cui': 'C0037657', 'cui_str': 'Somatomedin'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}]","[{'cui': 'C0202220', 'cui_str': 'Somatomedin-C measurement'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0597298', 'cui_str': 'Isoforms'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0972255', 'cui_str': 'type I collagen alpha 1'}, {'cui': 'C0024375', 'cui_str': 'Protein-lysine 6-oxidase'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}]",,0.0302591,"There is no marked increase in expression of COL1A1, COL3A1, COL5A1, and LOX genes in skeletal muscle after AAs administration.","[{'ForeName': 'Egor M', 'Initials': 'EM', 'LastName': 'Lednev', 'Affiliation': 'Institute of Biomedical Problems of the RAS, 76A Khoroshevskoye Shosse, Moscow 123007, Russian Federation. Electronic address: ledhauz@gmail.com.'}, {'ForeName': 'Irina V', 'Initials': 'IV', 'LastName': 'Kravchenko', 'Affiliation': 'Federal Research Centre «Fundamentals of Biotechnology» of the Russian Academy of Sciences, 33 build 2, Leninsky prospect, Moscow 119071, Russian Federation.'}, {'ForeName': 'Vladimir A', 'Initials': 'VA', 'LastName': 'Furalyov', 'Affiliation': 'Federal Research Centre «Fundamentals of Biotechnology» of the Russian Academy of Sciences, 33 build 2, Leninsky prospect, Moscow 119071, Russian Federation.'}, {'ForeName': 'Evgeny A', 'Initials': 'EA', 'LastName': 'Lysenko', 'Affiliation': 'Institute of Biomedical Problems of the RAS, 76A Khoroshevskoye Shosse, Moscow 123007, Russian Federation.'}, {'ForeName': 'Iulia S', 'Initials': 'IS', 'LastName': 'Lemesheva', 'Affiliation': 'Institute of Biomedical Problems of the RAS, 76A Khoroshevskoye Shosse, Moscow 123007, Russian Federation.'}, {'ForeName': 'Alexandr A', 'Initials': 'AA', 'LastName': 'Grushin', 'Affiliation': 'Russian Olympic Committee, Luzhnetskaya Embankment 8, Russia, Moscow 119991, Russian Federation.'}, {'ForeName': 'Vadim E', 'Initials': 'VE', 'LastName': 'Dubrov', 'Affiliation': 'Lomonosov Moscow State University, Faculty of Fundamental Medicine, 27 build. 1, Lomonosovsky Prospekt, Moscow 119991, Russian Federation.'}, {'ForeName': 'Olga L', 'Initials': 'OL', 'LastName': 'Vinogradova', 'Affiliation': 'Institute of Biomedical Problems of the RAS, 76A Khoroshevskoye Shosse, Moscow 123007, Russian Federation.'}, {'ForeName': 'Daniil V', 'Initials': 'DV', 'LastName': 'Popov', 'Affiliation': 'Institute of Biomedical Problems of the RAS, 76A Khoroshevskoye Shosse, Moscow 123007, Russian Federation.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2020.101323']
708,31688064,"Efficacy and Safety of Vonoprazan in Patients With Nonerosive Gastroesophageal Reflux Disease: A Randomized, Placebo-Controlled, Phase 3 Study.","OBJECTIVES


To assess the efficacy and safety of vonoprazan on heartburn symptoms in patients with nonerosive reflux disease (NERD) (ClinicalTrials.gov: NCT02954848).
METHODS


This phase 3, double-blind, placebo-controlled study included Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn. Patients received placebo (n = 245) or vonoprazan 10 mg (n = 238) for 4 weeks. The primary efficacy outcome was frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn). Other outcomes included cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution in the fourth week of treatment, and safety.
RESULTS


Compared with placebo, the proportion of days without heartburn was not significantly higher in the vonoprazan group in the full analysis (primary end point, 72.55% vs 61.50%, vonoprazan vs placebo, P = 0.0643) but was significantly higher in the per-protocol-set sensitivity analysis (P = 0.0341). Early onset of response and significantly greater cumulative improvement rates of heartburn were observed in the vonoprazan group (P = 0.0003). In a post hoc analysis, a greater proportion of patients with complete heartburn resolution in the fourth week of treatment were reported in the vonoprazan group (P = 0.0023). Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
DISCUSSION


Although vonoprazan 10 mg was not superior to placebo with respect to proportion of days without heartburn in Japanese patients with NERD, vonoprazan had a significantly higher cumulative rate of heartburn resolution and was well tolerated.",2019,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","['Patients With Nonerosive Gastroesophageal Reflux Disease', 'Japanese patients with NERD', 'patients with nonerosive reflux disease (NERD', 'Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn']","['placebo', 'Placebo', 'Vonoprazan', 'vonoprazan']","['cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution', 'safety', 'tolerated', 'cumulative rate of heartburn resolution', 'Incidence of treatment-emergent adverse events', 'efficacy and safety', 'complete heartburn resolution', 'heartburn symptoms', 'cumulative improvement rates of heartburn', 'proportion of days without heartburn', 'Efficacy and Safety', 'frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4080009', 'cui_str': 'Vonoprazan'}]","[{'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.488409,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","[{'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Gastroenterology and Hepatology, Shimane University School of Medicine, Izumo, Japan.'}, {'ForeName': 'Yuuichi', 'Initials': 'Y', 'LastName': 'Sakurai', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Takabayashi', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kudou', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Araki', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Miyagi', 'Affiliation': 'Department of Internal Medicine, Fukuyama Daiichi Hospital, Hiroshima, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Iwakiri', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Ashida', 'Affiliation': 'Department of Gastroenterology, Rakuwakai Otowa Hospital, Kyoto, Japan.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000101']
709,32407919,Application of a Microsurgical Space Restrictor in Microsurgical Simulation Training.,"OBJECTIVE


To investigate the effect of the application of a microsurgical space restrictor in microsurgical simulation training.
METHODS


A microsurgical space restrictor that can restrict the operation space was designed and produced. Forty neurosurgery residents with standardized training were selected as the study subjects and were randomly divided into the experimental group (group A) and the control group (group B). Group A was trained using the space restrictor, and group B was trained using the traditional method. The skills and overall performance of the 2 groups of trainees were assessed by the Stanford Microsurgery and Resident Training (SMaRT) scale. The assessment was divided into 2 stages: the unobstructed microsurgery test, and the test with the microsurgical operation space restrictor.
RESULTS


In group A, the score for the first stage (A1) was 3.9 ± 0.6, the score for the second stage (A2) was 3.4 ± 0.6, and the score for A1 was better than that for A2 (P = 0.000); in group B, the score for the first stage (B1) was 3.57 ± 0.6, the score for the second stage (B2) was 3.0 ± 0.6, and the score for B1 was better than that for B2 (P = 0.000). Overall, the score for A1 was better than that for B1 (P = 0.046), and the score for A2 was better than that for B2 (P = 0.009).
CONCLUSIONS


Microsurgical space restrictor use can improve the effect of microsurgical simulation training and help trainees better master microsurgical operation skills.",2020,"Overall, the score for A1 was better than that for B1 (P = 0.046), and the score for A2 was better than that for B2 (P = 0.009).
",['Forty neurosurgery residents with standardized training were selected as the study subjects'],"['microsurgical simulation training', 'Microsurgical Space Restrictor']",['Stanford Microsurgery and Resident Training (SMaRT) scale'],"[{'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}]","[{'cui': 'C0026035', 'cui_str': 'Microsurgery'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",40.0,0.0137644,"Overall, the score for A1 was better than that for B1 (P = 0.046), and the score for A2 was better than that for B2 (P = 0.009).
","[{'ForeName': 'Zuowei', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Neurospine Center, China International Neuroscience Institute, Beijing, People's Republic of China; Department of Neurosurgery, Education Department, Beijing Hospital, National Center of Gerontology, Beijing, People's Republic of China.""}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Neurosurgery, Education Department, Beijing Hospital, National Center of Gerontology, Beijing, People's Republic of China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Kong', 'Affiliation': ""Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Neurospine Center, China International Neuroscience Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Zan', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ""Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Neurospine Center, China International Neuroscience Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ""Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Neurospine Center, China International Neuroscience Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Xingwen', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Neurospine Center, China International Neuroscience Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Fengzeng', 'Initials': 'F', 'LastName': 'Jian', 'Affiliation': ""Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Neurospine Center, China International Neuroscience Institute, Beijing, People's Republic of China. Electronic address: jianfengzeng@xwh.ccmu.edu.cn.""}]",World neurosurgery,['10.1016/j.wneu.2020.05.031']
710,29876366,The Rapid Prediction of Carbapenem Resistance in Patients With  Klebsiella pneumoniae  Bacteremia Using Electronic Medical Record Data.,"Background


The administration of active antibiotics is often delayed in cases of carbapenem-resistant gram-negative bacteremia. Using electronic medical record (EMR) data to rapidly predict carbapenem resistance in patients with  Klebsiella pneumoniae  bacteremia could help reduce the time to active therapy.
Methods


All cases of  Klebsiella pneumoniae  bacteremia at Mount Sinai Hospital from September 2012 through September 2016 were included. Cases were randomly divided into a ""training set"" and a ""testing set."" EMR data from the training set cases were reviewed, and significant risk factors for carbapenem resistance were entered into a multiple logistic regression model. Performance was assessed by repeated K-fold cross-validation and by applying the training set model to the testing set. All cases were also reviewed to determine the time to effective antibiotic therapy.
Results


A total of 613 cases of  Klebsiella pneumoniae  bacteremia were included, 61 (10%) of which were carbapenem-resistant. The training and testing sets consisted of 460 and 153 cases, respectively. The regression model derived from the training set correctly predicted 73% of carbapenem-resistant cases and 59% of carbapenem-susceptible cases in the testing set (sensitivity, 73%; specificity, 59%; positive predictive value, 16%; negative predictive value, 95%). The mean area under the receiver operator characteristic curve of the K-fold cross-validation repeats was 0.731. Patients with carbapenem-resistant infections received active antibiotics significantly later than those with susceptible infections (40.4 hours vs 9.6 hours,  P  < .0001).
Conclusions


A multiple logistic regression model using EMR data can generate rapid, sensitive predictions of carbapenem resistance in patients with  Klebsiella pneumoniae  bacteremia, which could help shorten the time to effective therapy in these cases.",2018,"Patients with carbapenem-resistant infections received active antibiotics significantly later than those with susceptible infections (40.4 hours vs 9.6 hours,  P  < .0001).
","['All cases of  Klebsiella pneumoniae  bacteremia at Mount Sinai Hospital from September 2012 through September 2016 were included', 'patients with  Klebsiella pneumoniae  bacteremia', 'A total of 613 cases of  Klebsiella pneumoniae  bacteremia were included, 61 (10%) of which were carbapenem-resistant', 'Patients With  Klebsiella pneumoniae  Bacteremia']","['active antibiotics', 'training set"" and a ""testing set']",[],"[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0001699', 'cui_str': 'Klebsiella pneumoniae'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0181909', 'cui_str': 'Mount (physical object)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0006968', 'cui_str': 'Antibiotics, Carbapenem'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0036849', 'cui_str': 'Set'}]",[],,0.0258054,"Patients with carbapenem-resistant infections received active antibiotics significantly later than those with susceptible infections (40.4 hours vs 9.6 hours,  P  < .0001).
","[{'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Sullivan', 'Affiliation': 'Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Ichikawa', 'Affiliation': 'Department of Genetics and Genomic Sciences, Institute of Next Generation Healthcare, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Dudley', 'Affiliation': 'Department of Genetics and Genomic Sciences, Institute of Next Generation Healthcare, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Genetics and Genomic Sciences, Institute of Next Generation Healthcare, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Aberg', 'Affiliation': 'Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York, New York.'}]",Open forum infectious diseases,['10.1093/ofid/ofy091']
711,31660381,Pharmacokinetics and Pharmacodynamics of Conventional-Dose vs Triple-Dose Oseltamivir in Severely Immunocompromised Children With Influenza.,"This randomized phase 1b study evaluated the pharmacokinetics/pharmacodynamics of conventional-dose (30-75 mg twice daily [BID]) vs triple-dose (90-225 mg BID; weight-adjusted) oseltamivir for treatment of influenza in severely immunocompromised children <13 years. Oseltamivir carboxylate (OC) C max  and AUC 0-12h  were ~2-fold higher with triple-dose vs conventional-dose oseltamivir. Increased dose/exposure of oseltamivir/OC did not improve virological outcomes or reduce viral resistance. Median time to cessation of viral shedding was similar with triple-dose and conventional-dose oseltamivir (150.7 vs 157.1 hours, respectively); median time to alleviation of baseline fever was longer with conventional-dose oseltamivir (28.4 vs 11.3 hours). No new safety signals were identified.",2019,"Median time to cessation of viral shedding was similar with triple-dose and conventional-dose oseltamivir (150.7 vs 157.1 hours, respectively); median time to alleviation of baseline fever was longer with conventional-dose oseltamivir (28.4 vs 11.3 hours).","['Severely Immunocompromised Children With Influenza', 'severely immunocompromised children <13 years']","['oseltamivir/OC', 'conventional-dose (30-75 mg twice daily [BID]) vs triple-dose (90-225 mg BID; weight-adjusted) oseltamivir', 'Conventional-Dose vs Triple-Dose Oseltamivir', 'Oseltamivir carboxylate']","['OC) C max  and AUC 0-12h', 'virological outcomes or reduce viral resistance', 'Median time to cessation of viral shedding', 'median time to alleviation of baseline fever']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0085393', 'cui_str': 'Immunosuppressed Host'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C2713885', 'cui_str': 'oseltamivir carboxylate'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0520989', 'cui_str': 'Viral resistance, function (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}]",,0.0376708,"Median time to cessation of viral shedding was similar with triple-dose and conventional-dose oseltamivir (150.7 vs 157.1 hours, respectively); median time to alleviation of baseline fever was longer with conventional-dose oseltamivir (28.4 vs 11.3 hours).","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Bautista', 'Affiliation': 'Pediatric Hematology, Oncology and Stem Cell Transplantation Department, Hospital Infantil Universitario Niño Jesús, Madrid, Spain.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Engelhard', 'Affiliation': 'Department of Pediatrics, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Rizzari', 'Affiliation': 'Pediatric Hematology-Oncology Unit, Department of Pediatrics, MBBM Foundation, ASST-Monza, University of Milano-Bicocca, Monza, Italy.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Baka', 'Affiliation': ""Department of Pediatric Oncology, Aglaia Kyriakou Children's Hospital, Athens, Greece.""}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Saavedra-Lozano', 'Affiliation': 'Infectious Disease Unit, Department of Pediatrics, Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Lopez-Medina', 'Affiliation': 'Department of Pediatrics, Universidad del Valle, Centro Médico Imbanaco and Centro de Estudios en Infectología Pediátrica, Cali, Colombia.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Nasmyth-Miller', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Jules', 'Initials': 'J', 'LastName': 'Hernández-Sánchez', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Sturm', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharmaceutical Research and Early Development, Basel, Switzerland.'}]",Open forum infectious diseases,['10.1093/ofid/ofz430']
712,30684769,Effectiveness of conservative urinary incontinence management among female nursing home residents-A cluster RCT.,"BACKGROUND


Guideline-compliant conservative management of urinary incontinence (UI) is the first step of the initial management for UI and is recommended for long-term care in older persons. Recent studies have focused on the effects of guideline-compliant UI management. However, most of these studies were tested in another setting than nursing homes and were not focused on conservative management.
AIMS


To measure the effectiveness of 29 evidence-based nursing recommendations regarding the conservative management of UI in Austrian nursing homes.
METHODS


The study is a cluster randomized intervention trial with institution as the unit of randomization. Twelve nursing homes in two Austrian provinces (Styria, Carinthia) were randomly allocated to the intervention group (IG) and control group (CG). Data were collected from participating residents over a three-month period. The intervention consisted of the implementation of recommendations for the conservative management of UI among female nursing home residents. The primary outcome variable was the daily UI experienced by the participating residents.
RESULTS


Residents in the (IG n = 216) had a lower risk (OR = 0.14, p = 0.02) of experiencing daily UI and were less likely to receive absorbent products (OR = 0.01, p = 0.01) than residents in the CG (n = 165). Residents in the IG (OR = 5.16, p = 0.00) were five times more likely to receive recommended interventions (e.g., bladder training) than residents in the CG.
CONCLUSION


Introducing guideline-compliant management into nursing practice can increase the likelihood of evidence-based interventions for the conservative management of UI. The intervention in this study targeted on nurses/nurse managers and can be recommended for the nursing home setting.",2019,Introducing guideline-compliant management into nursing practice can increase the likelihood of evidence-based interventions for the conservative management of UI.,"['Twelve nursing homes in two Austrian provinces (Styria, Carinthia', 'Austrian nursing homes', 'older persons', 'female nursing home residents']","['conservative urinary incontinence management', 'intervention group (IG) and control group (CG']",['daily UI experienced by the participating residents'],"[{'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0337795', 'cui_str': 'Austrians (ethnic group)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",,0.0231308,Introducing guideline-compliant management into nursing practice can increase the likelihood of evidence-based interventions for the conservative management of UI.,"[{'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Hödl', 'Affiliation': 'Medical University of Graz, Institute of Nursing Science, Universitätsplatz 4/3, 8010 Graz, Austria. Electronic address: manuela.hoedl@medunigraz.at.'}, {'ForeName': 'Ruud J G', 'Initials': 'RJG', 'LastName': 'Halfens', 'Affiliation': 'Maastricht University, Department of Health Services Research, CAPHRI, Care and Public Health Research Institute, Duboisdomein 30, 6229 GT Maastricht, the Netherlands. Electronic address: r.halfens@maastrichtuniversity.nl.'}, {'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Lohrmann', 'Affiliation': 'Medical University of Graz, Institute of Nursing Science, Universitätsplatz 4/3, 8010 Graz, Austria. Electronic address: christa.lohrmann@medunigraz.at.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2019.01.003']
713,30636649,"Minding the Baby ®: Enhancing parental reflective functioning and infant attachment in an attachment-based, interdisciplinary home visiting program.","In this article, we describe the results of the second phase of a randomized controlled trial of Minding the Baby (MTB), an interdisciplinary reflective parenting intervention for infants and their families. Young first-time mothers living in underserved, poor, urban communities received intensive home visiting services from a nurse and social worker team for 27 months, from pregnancy to the child's second birthday. Results indicate that MTB mothers' levels of reflective functioning was more likely to increase over the course of the intervention than were those of control group mothers. Likewise, infants in the MTB group were significantly more likely to be securely attached, and significantly less likely to be disorganized, than infants in the control group. We discuss our findings in terms of their contribution to understanding the impacts and import of intensive intervention with vulnerable families during the earliest stages of parenthood in preventing the intergenerational transmission of disrupted relationships and insecure attachment.",2020,Results indicate that MTB mothers' levels of reflective functioning was more likely to increase over the course of the intervention than were those of control group mothers.,"['infants and their families', 'Young first-time mothers living in underserved, poor, urban communities received']","['intensive home visiting services', 'Minding the Baby®', 'interdisciplinary reflective parenting intervention', 'Minding the Baby (MTB']","[""MTB mothers' levels of reflective functioning""]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0280011,Results indicate that MTB mothers' levels of reflective functioning was more likely to increase over the course of the intervention than were those of control group mothers.,"[{'ForeName': 'Arietta', 'Initials': 'A', 'LastName': 'Slade', 'Affiliation': 'Yale Child Study Center, New Haven, CT, USA.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Holland', 'Affiliation': 'Yale University School of Nursing, New Haven, CT, USA.'}, {'ForeName': 'Monica Roosa', 'Initials': 'MR', 'LastName': 'Ordway', 'Affiliation': 'Yale University School of Nursing, New Haven, CT, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Carlson', 'Affiliation': 'Institute of Child Development, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Sangchoon', 'Initials': 'S', 'LastName': 'Jeon', 'Affiliation': 'Yale University School of Nursing, New Haven, CT, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Close', 'Affiliation': 'Yale Child Study Center, New Haven, CT, USA.'}, {'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Mayes', 'Affiliation': 'Yale Child Study Center, New Haven, CT, USA.'}, {'ForeName': 'Lois S', 'Initials': 'LS', 'LastName': 'Sadler', 'Affiliation': 'Yale Child Study Center, New Haven, CT, USA.'}]",Development and psychopathology,['10.1017/S0954579418001463']
714,30378231,"Varenicline and nabilone in tobacco and cannabis co-users: effects on tobacco abstinence, withdrawal and a laboratory model of cannabis relapse.","Tobacco and cannabis co-users (T+CUs) have poor cannabis cessation outcomes, but the mechanisms underlying this are not well understood. This laboratory study examined the effects of (1) the partial nicotinic agonist, varenicline, on tobacco cessation among T+CUs, and (2) varenicline, alone, and when combined with the cannabinoid agonist nabilone, on cannabis withdrawal and a laboratory model of cannabis relapse. Non-treatment-seeking T+CUs were randomized to active-varenicline or placebo-varenicline, and completed a 15-day outpatient phase; varenicline was titrated to 1 mg BID during days 1-8, and participants were instructed to abstain from tobacco during days 9-15. Participants then moved inpatient for 16 days, where they continued their outpatient medication and tobacco abstinence. Inpatient testing included two, 8-day medication periods, where active-nabilone and placebo-nabilone were administered in counterbalanced order, and measures of acute cannabis effects (days 1-2), withdrawal (days 4-5) and 'relapse' (days 6-8) were collected. Participants in the active-varenicline group were more likely to achieve cotinine-verified tobacco abstinence during the outpatient period versus placebo-varenicline group (46 percent versus 24 percent, respectively), and also reported less mood disturbance and cigarette craving while inpatient. Active-nabilone attenuated cannabis withdrawal in both groups but did not affect cannabis relapse. Regression analyses revealed that two tobacco-related variables, i.e. age of first cigarette use, and cigarette craving while inpatient, were independent predictors of cannabis relapse outcomes. Thus, varenicline holds promise in this population, as a tool to examine the effects of tobacco abstinence on cannabis use outcomes, and as a component of smoking cessation treatments targeting T+CUs.",2019,Active-nabilone attenuated cannabis withdrawal in both groups but did not affect cannabis relapse.,"['tobacco and cannabis co-users', 'cannabis relapse. Non-treatment-seeking T+CUs']","['Varenicline', 'placebo-varenicline', 'partial nicotinic agonist, varenicline, on tobacco cessation among T+CUs, and (2) varenicline, alone, and when combined with the cannabinoid agonist nabilone', 'varenicline', 'active-nabilone and placebo-nabilone', 'Tobacco and cannabis co-users (T+CUs', 'active-varenicline or placebo-varenicline']","['cotinine-verified tobacco abstinence', 'mood disturbance and cigarette craving', 'cannabis relapse']","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0242948', 'cui_str': 'Cholinergic Agonists, Nicotinic'}, {'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C2927148', 'cui_str': 'Cannabinoid Receptor Activators'}, {'cui': 'C0068333', 'cui_str': 'nabilone'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}]","[{'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",15.0,0.224657,Active-nabilone attenuated cannabis withdrawal in both groups but did not affect cannabis relapse.,"[{'ForeName': 'Evan S', 'Initials': 'ES', 'LastName': 'Herrmann', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute, Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Ziva D', 'Initials': 'ZD', 'LastName': 'Cooper', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute, Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Gillinder', 'Initials': 'G', 'LastName': 'Bedi', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute, Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Ramesh', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute, Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Stephanie Collins', 'Initials': 'SC', 'LastName': 'Reed', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute, Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Sandra D', 'Initials': 'SD', 'LastName': 'Comer', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute, Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Foltin', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute, Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Haney', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute, Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}]",Addiction biology,['10.1111/adb.12664']
715,30658908,Changes in the nutritional statuses of edentulous elderly patients after new denture fabrication with and without providing simple dietary advice.,"PURPOSE


Providing appropriate dental prostheses and dietary interventions may improve food and nutrient intake in elderly edentulous patients, but evidence to support their use is scarce. In this trial, we aimed to clarify the combined effect, on the nutritional statuses of edentulous elderly patients, of dentists providing complete dentures with dietary advice.
METHODS


A randomized-controlled trial was performed on a healthy elderly population who required new complete dentures. All participants had new complete dentures fabricated and were randomly divided into an intervention or a control group. The intervention group received simple dietary advice through standardized patient information leaflets and the control group received advice on denture care only. Nutritional status was assessed using the Mini Nutritional Assessment short-form (MNA-SF) before and at 3 and 6months after treatment. At each assessment point, the MNA-SF scores were compared using the Mann-Whitney U test. The within-group differences in the MNA-SF scores were analyzed using the Wilcoxon signed-rank test with Bonferroni correction.
RESULTS


In total, 59 participants completed all trial steps. At 6months after treatment, the MNA-SF score in the intervention group was significantly higher than that in the control group (p=0.01). Comparing the within-group changes in the MNA-SF score revealed that the score increased significantly from 3 to 6months in the intervention group (p=0.001, Bonferroni correction).
CONCLUSIONS


Nutritional statuses of healthy edentulous elderly population might be improved by fabricating new complete dentures and providing simple dietary advice.",2019,"At 6months after treatment, the MNA-SF score in the intervention group was significantly higher than that in the control group (p=0.01).","['healthy edentulous elderly population', 'elderly edentulous patients', '59 participants completed all trial steps', 'All participants had new complete dentures fabricated', 'edentulous elderly patients', 'healthy elderly population who required new complete dentures', 'edentulous elderly patients, of dentists providing complete dentures with dietary advice']",['simple dietary advice through standardized patient information leaflets and the control group received advice on denture care only'],"['MNA-SF score', 'MNA-SF scores']","[{'cui': 'C0026644', 'cui_str': 'Mouth, Toothless'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0011455', 'cui_str': 'Denture, Complete'}, {'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C0204932', 'cui_str': 'Diet education (procedure)'}]","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0204932', 'cui_str': 'Diet education (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0204759', 'cui_str': 'Special care of dentures (regime/therapy)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",59.0,0.026195,"At 6months after treatment, the MNA-SF score in the intervention group was significantly higher than that in the control group (p=0.01).","[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, TMDU, Tokyo, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Kanazawa', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, TMDU, Tokyo, Japan. Electronic address: m.kanazawa.gerd@tmd.ac.jp.'}, {'ForeName': 'Yuriko', 'Initials': 'Y', 'LastName': 'Komagamine', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, TMDU, Tokyo, Japan.'}, {'ForeName': 'Maiko', 'Initials': 'M', 'LastName': 'Iwaki', 'Affiliation': 'Oral Diagnosis and General Dentistry, University Hospital of Dentistry, Tokyo Medical and Dental University, TMDU, Tokyo, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Amagai', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, TMDU, Tokyo, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Minakuchi', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, TMDU, Tokyo, Japan.'}]",Journal of prosthodontic research,['10.1016/j.jpor.2018.12.010']
716,30671805,Clamp-Crush Technique Versus Harmonic Scalpel for Hepatic Parenchymal Transection in Living Donor Hepatectomy: a Randomized Controlled Trial.,"BACKGROUND


Hepatic parenchymal transection is the most invasive step in donor operation. During this step, blood loss and unintended injuries to the intrahepatic structures and hepatic remnant may occur. There is no evidence to prove the ideal techniques for hepatic parenchymal transection. The aim of this study is to compare the safety, efficacy, and outcome of clamp-crush technique versus harmonic scalpel as a method of parenchymal transection in living-donor hepatectomy.
METHODS


Consecutive living liver donors, undergoing right hemi-hepatectomy, during the period between May 2015 and April 2016, were included in this prospective randomized study. Cases were randomized into two groups; group (A) harmonic scalpel group and group (B) Clamp-crush group.
RESULTS


During the study period, 72 cases underwent right hemi-hepatectomy for adult living donor liver transplantation and were randomized into two groups. There were no statistically significant differences between the two groups regarding preoperative demographic and radiological data. Longer operation time and hepatectomy duration were found in group B. There were no significant differences between the two groups regarding blood loss, blood loss during hepatectomy, and blood transfusion. More unexpected bleeding events occurred in group A. Higher necrosis at the cut margin of the liver parenchyma was noted in group A. There were no statistically significant differences between the two groups regarding postoperative ICU stay, hospital stay, postoperative morbidities, and readmission rates.
CONCLUSION


Clamp-crush technique is advocated as a simple, easy, safe, and cheaper method for hepatic parenchymal transection in living donors.",2019,"There were no statistically significant differences between the two groups regarding postoperative ICU stay, hospital stay, postoperative morbidities, and readmission rates.
","['living-donor hepatectomy', 'Consecutive living liver donors, undergoing right hemi-hepatectomy, during the period between May 2015 and April 2016', '72 cases underwent right hemi-hepatectomy for adult living donor liver transplantation', 'Living Donor Hepatectomy']","['Clamp-Crush Technique Versus Harmonic Scalpel', 'clamp-crush technique versus harmonic scalpel', 'Clamp-crush technique', 'harmonic scalpel group and group (B) Clamp-crush group']","['blood loss, blood loss during hepatectomy, and blood transfusion', 'preoperative demographic and radiological data', 'Longer operation time and hepatectomy duration', 'postoperative ICU stay, hospital stay, postoperative morbidities, and readmission rates', 'bleeding events', 'safety, efficacy']","[{'cui': 'C0348050', 'cui_str': 'Living Donors'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0302512', 'cui_str': 'Donor for liver transplant (person)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C1285521', 'cui_str': 'Hemi'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}]","[{'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0185060', 'cui_str': 'Crushing - action (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0392220', 'cui_str': 'Surgical knife, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0220947,"There were no statistically significant differences between the two groups regarding postoperative ICU stay, hospital stay, postoperative morbidities, and readmission rates.
","[{'ForeName': 'Ahmad Mohamed', 'Initials': 'AM', 'LastName': 'Sultan', 'Affiliation': 'Liver Transplantation Unit, Gastrointestinal Surgery Center, Department of Surgery, College of Medicine, Mansoura University, Gastrointestinal Surgery Center, Gehan Street, Mansoura, 35516, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Shehta', 'Affiliation': 'Liver Transplantation Unit, Gastrointestinal Surgery Center, Department of Surgery, College of Medicine, Mansoura University, Gastrointestinal Surgery Center, Gehan Street, Mansoura, 35516, Egypt. ahmedshehta@mans.edu.eg.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Salah', 'Affiliation': 'Liver Transplantation Unit, Gastrointestinal Surgery Center, Department of Surgery, College of Medicine, Mansoura University, Gastrointestinal Surgery Center, Gehan Street, Mansoura, 35516, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elshoubary', 'Affiliation': 'Liver Transplantation Unit, Gastrointestinal Surgery Center, Department of Surgery, College of Medicine, Mansoura University, Gastrointestinal Surgery Center, Gehan Street, Mansoura, 35516, Egypt.'}, {'ForeName': 'Ahmed Nabieh', 'Initials': 'AN', 'LastName': 'Elghawalby', 'Affiliation': 'Liver Transplantation Unit, Gastrointestinal Surgery Center, Department of Surgery, College of Medicine, Mansoura University, Gastrointestinal Surgery Center, Gehan Street, Mansoura, 35516, Egypt.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Said', 'Affiliation': 'Liver Transplantation Unit, Gastrointestinal Surgery Center, Department of Surgery, College of Medicine, Mansoura University, Gastrointestinal Surgery Center, Gehan Street, Mansoura, 35516, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elmorshedi', 'Affiliation': 'Department of Anesthesia and Intensive Care, Gastrointestinal Surgery Center, College of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Marwan', 'Affiliation': 'Department of Hepatology, Gastrointestinal Surgery Center, College of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Usama', 'Initials': 'U', 'LastName': 'Shiha', 'Affiliation': 'Diagnostic & Interventional Radiology Department, Gastrointestinal Surgery Center, College of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Fathy', 'Affiliation': 'Liver Transplantation Unit, Gastrointestinal Surgery Center, Department of Surgery, College of Medicine, Mansoura University, Gastrointestinal Surgery Center, Gehan Street, Mansoura, 35516, Egypt.'}, {'ForeName': 'Mohamed Abdel', 'Initials': 'MA', 'LastName': 'Wahab', 'Affiliation': 'Liver Transplantation Unit, Gastrointestinal Surgery Center, Department of Surgery, College of Medicine, Mansoura University, Gastrointestinal Surgery Center, Gehan Street, Mansoura, 35516, Egypt.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-019-04103-5']
717,30515431,Effect of Commonly Used Pediatric Antibiotics on Gut Microbial Diversity in Preschool Children in Burkina Faso: A Randomized Clinical Trial.,"Background


Exposure to antibiotics may result in alterations to the composition of intestinal microbiota. However, few trials have been conducted, and observational studies are subject to confounding by indication. We conducted a randomized controlled trial to determine the effect of 3 commonly used pediatric antibiotics on the intestinal microbiome in healthy preschool children.
Methods


Children aged 6-59 months were randomized (1:1:1:1) to a 5-day course of 1 of 3 antibiotics, including amoxicillin (25 mg/kg/d twice-daily doses), azithromycin (10 mg/kg dose on day 1 and then 5 mg/kg once daily for 4 days), cotrimoxazole (240 mg once daily), or placebo. Rectal swabs were obtained at baseline and 5 days after the last dose and were processed using 16S rRNA gene sequencing. The prespecified primary outcome was inverse Simpson's α-diversity index.
Results


Post-treatment Simpson's diversity was significantly different across the 4 arms ( P  = .003). The mean Simpson's α-diversity among azithromycin-treated children was significantly lower than in placebo-treated children (6.6; 95% confidence interval [CI], 5.5-7.8; vs 9.8; 95% CI, 8.7-10.9;  P  = .0001). Diversity in children treated with amoxicillin (8.3; 95% CI, 7.0-9.6;  P  = .09) or cotrimoxazole (8.3; 95% CI, 8.2-9.7;  P  = .08) was not significantly different than placebo.
Conclusions


Azithromycin affects the composition of the pediatric intestinal microbiome. The effect of amoxicillin and cotrimoxazole on microbiome composition was less clear.
Clinical Trials Registration


clinicaltrials.gov NCT03187834.",2018,"The mean Simpson's α-diversity among azithromycin-treated children was significantly lower than in placebo-treated children (6.6; 95% confidence interval [CI], 5.5-7.8; vs 9.8; 95% CI, 8.7-10.9;  P  = .0001).","['Preschool Children in Burkina Faso', 'Methods\n\n\nChildren aged 6-59 months', 'healthy preschool children']","['placebo', 'amoxicillin', 'Azithromycin', 'azithromycin', 'Commonly Used Pediatric Antibiotics', 'amoxicillin and cotrimoxazole', '3 commonly used pediatric antibiotics', 'cotrimoxazole']","[""mean Simpson's α-diversity"", 'microbiome composition', ""inverse Simpson's α-diversity index"", 'Gut Microbial Diversity']","[{'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0006409', 'cui_str': 'Upper Volta'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0041044', 'cui_str': 'Sulfamethoxazole / Trimethoprim'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0439850', 'cui_str': 'Inverse (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.746474,"The mean Simpson's α-diversity among azithromycin-treated children was significantly lower than in placebo-treated children (6.6; 95% confidence interval [CI], 5.5-7.8; vs 9.8; 95% CI, 8.7-10.9;  P  = .0001).","[{'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Francis I. Proctor Foundation.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sié', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Boubacar', 'Initials': 'B', 'LastName': 'Coulibaly', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Lucienne', 'Initials': 'L', 'LastName': 'Ouermi', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Dah', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Charlemagne', 'Initials': 'C', 'LastName': 'Tapsoba', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Heidelberg Institute of Public Health, Heidelberg, Germany.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Ray', 'Affiliation': 'Francis I. Proctor Foundation.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': 'Francis I. Proctor Foundation.'}, {'ForeName': 'Susie', 'Initials': 'S', 'LastName': 'Cummings', 'Affiliation': 'Francis I. Proctor Foundation.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lebas', 'Affiliation': 'Francis I. Proctor Foundation.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I. Proctor Foundation.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I. Proctor Foundation.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Doan', 'Affiliation': 'Francis I. Proctor Foundation.'}]",Open forum infectious diseases,['10.1093/ofid/ofy289']
718,31533906,"Patiromer versus placebo to enable spironolactone use in patients with resistant hypertension and chronic kidney disease (AMBER): a phase 2, randomised, double-blind, placebo-controlled trial.","BACKGROUND


Spironolactone is effective at reducing blood pressure in patients with uncontrolled resistant hypertension. However, the use of spironolactone in patients with chronic kidney disease can be restricted by hyperkalaemia. We evaluated use of the potassium binder patiromer to allow more persistent use of spironolactone in patients with chronic kidney disease and resistant hypertension.
METHODS


In this phase 2 multicentre, randomised, double-blind, placebo-controlled study, we enrolled participants aged 18 years and older with chronic kidney disease (estimated glomerular filtration rate 25 to ≤45 mL/min per 1·73 m 2 ) and uncontrolled resistant hypertension from 62 outpatient centres in ten countries (Bulgaria, Croatia, Georgia, Hungary, Ukraine, France, Germany, South Africa, the UK, and the USA). Patients meeting all eligibility criteria at the final screening visit were stratified by local serum potassium measurement (4·3 to <4·7 mmol/L vs 4·7 to 5·1 mmol/L) and history of diabetes. Participants were randomly assigned (1:1) with an interactive web response system to receive either placebo or patiromer (8·4 g once daily), in addition to open-label spironolactone (starting at 25 mg once daily) and their baseline blood pressure medications. Participants, the study team that administered treatments and measured blood pressure, and the investigators were masked to assigned treatment groups. Dose titrations were permitted after 1 week (patiromer) and 3 weeks (spironolactone). The primary endpoint was the between-group difference at week 12 in the proportion of patients on spironolactone. Efficacy endpoints and safety were assessed in all randomised patients (intention to treat). The study was registered with Clinicaltrials.gov, NCT03071263.
FINDINGS


Between Feb 13, 2017, and Aug 20, 2018, we screened 574 patients. 295 (51%) of 574 patients met all inclusion criteria and were randomly assigned to spironolactone in addition to double-blind treatment with either placebo (n=148) or patiromer (n=147). At week 12, 98 (66%) of 148 patients in the placebo group and 126 (86%) of 147 patients in the patiromer group remained on spironolactone (between-group difference 19·5%, 95% CI 10·0-29·0; p<0·0001). Adverse events were mostly mild or moderate in severity and occurred in 79 (53%) of 148 patients in the placebo group and 82 (56%) of 147 patients in the patiromer group.
INTERPRETATION


In patients with resistant hypertension and chronic kidney disease, patiromer enabled more patients to continue treatment with spironolactone with less hyperkalaemia. Persistent spironolactone enablement in this population of patients has clinical relevance for the treatment of resistant hypertension.
FUNDING


Relypsa, a Vifor Pharma Group Company.",2019,"Adverse events were mostly mild or moderate in severity and occurred in 79 (53%) of 148 patients in the placebo group and 82 (56%) of 147 patients in the patiromer group.
","['574 patients', 'patients with chronic kidney disease', 'Between Feb 13, 2017, and Aug 20, 2018', 'patients with uncontrolled resistant hypertension', 'patients with chronic kidney disease and resistant hypertension', '295 (51%) of 574 patients met all inclusion criteria', 'patients with resistant hypertension and chronic kidney disease', 'Patients meeting all eligibility criteria at the final screening visit were stratified by local serum potassium measurement (4·3 to <4·7 mmol/L vs 4·7 to 5·1 mmol/L) and history of diabetes', 'enrolled participants aged 18 years and older with chronic kidney disease (estimated glomerular filtration rate 25 to ≤45 mL/min per 1·73 m 2 ) and uncontrolled resistant hypertension from 62 outpatient centres in ten countries (Bulgaria, Croatia, Georgia, Hungary, Ukraine, France, Germany, South Africa, the UK, and the USA']","['open-label spironolactone', 'Spironolactone', 'placebo', 'spironolactone', 'placebo or patiromer (8·4']","['Adverse events', 'hyperkalaemia', 'blood pressure', 'Efficacy endpoints and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3811844'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0006368', 'cui_str': 'Bulgaria'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0017454', 'cui_str': 'Georgian S.S.R.'}, {'cui': 'C0020174', 'cui_str': 'Hungary'}, {'cui': 'C0041580', 'cui_str': 'Ukraine'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4045522', 'cui_str': 'patiromer'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",574.0,0.467562,"Adverse events were mostly mild or moderate in severity and occurred in 79 (53%) of 148 patients in the placebo group and 82 (56%) of 147 patients in the patiromer group.
","[{'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Department of Medicine, Division of Nephrology, Indiana University and Richard L Roudebush VA Medical Center, Indianapolis, IN, USA. Electronic address: ragarwal@iu.edu.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': 'University of Lorraine, Institut National de la Santé et de la Recherche Médicale (Inserm) 1433 CIC-P CHRU de Nancy, Inserm U1116 and French Clinical Research Infrastructure Network INI-CRCT, Nancy, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Romero', 'Affiliation': 'Medical Affairs, Relypsa, a Vifor Pharma Group Company, Redwood City, CA, USA.'}, {'ForeName': 'Dahlia', 'Initials': 'D', 'LastName': 'Garza', 'Affiliation': 'Clinical Development, Relypsa, a Vifor Pharma Group Company, Redwood City, CA, USA.'}, {'ForeName': 'Martha R', 'Initials': 'MR', 'LastName': 'Mayo', 'Affiliation': 'Clinical Development, Relypsa, a Vifor Pharma Group Company, Redwood City, CA, USA.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Warren', 'Affiliation': 'Clinical Development, Relypsa, a Vifor Pharma Group Company, Redwood City, CA, USA.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Biometrics, Relypsa, a Vifor Pharma Group Company, Redwood City, CA, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'White', 'Affiliation': 'Calhoun Cardiology Center, University of Connecticut School of Medicine, Farmington, CT, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'Institute of Cardiovascular Sciences University College London (UCL) and National Institute for Health Research UCL/UCL Hospitals Biomedical Research Centre, London, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(19)32135-X']
719,32408551,Changing Exposure Perceptions: A Randomized Controlled Trial of an Intervention with Smoking Parents.,"Children who live with smokers are at risk of poor health, and of becoming smokers themselves. Misperceptions of the nature of tobacco smoke exposure have been demonstrated among parents, resulting in continued smoking in their children's environment. This study aimed to change parents' perceptions of exposure by providing information on second- and third-hand exposure and personalised information on children's exposure [NIH registry (NCT02867241)]. One hundred and fifty-nine families with a child < 8 years and at least one smoking parent were randomized into intervention (69), control (70), and enhanced control (20) groups. Reported exposure, parental smoking details, and a child hair sample were obtained at the start of the study and 6-8 months later. Parental perceptions of exposure (PPE) were assessed via a questionnaire. The intervention consisted of motivational interviews, feedback of home air quality and child's hair nicotine level, and information brochures. PPE were significantly higher at the study end (94.6 ± 17.6) compared to study beginning (86.5 ± 19.3) in intervention and enhanced control groups (t(72) = -3.950;  p  < 0.001). PPE at study end were significantly higher in the intervention group compared to the regular control group ( p  = 0.020). There was no significant interaction between time and group. Parallel changes in parental smoking behaviour were found. Parental perceptions of exposure were increased significantly post intervention, indicating that they can be altered. By making parents more aware of exposure and the circumstances in which it occurs, we can help parents change their smoking behaviour and better protect their children.",2020,PPE at study end were significantly higher in the intervention group compared to the regular control group ( p  = 0.020).,"['Children who live with smokers', 'One hundred and fifty-nine families with a child < 8 years and at least one smoking parent']","[""motivational interviews, feedback of home air quality and child's hair nicotine level, and information brochures""]","['parental smoking behaviour', 'PPE', 'Parental perceptions of exposure (PPE']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C2371710', 'cui_str': 'Air Quality'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0202431', 'cui_str': 'Nicotine measurement'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",159.0,0.0176672,PPE at study end were significantly higher in the intervention group compared to the regular control group ( p  = 0.020).,"[{'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Myers', 'Affiliation': 'Department of Health Promotion, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Ramat Aviv, Tel Aviv 6997801, Israel.'}, {'ForeName': 'Shoshana', 'Initials': 'S', 'LastName': 'Shiloh', 'Affiliation': 'School of Psychological Sciences, Gershon H. Gordon Faculty of Social Sciences, Tel Aviv University, Ramat Aviv, Tel Aviv 6997801, Israel.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Zucker', 'Affiliation': 'Department of Statistics, Hebrew University, Mount Scopus, Jerusalem 9190501, Israel.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Rosen', 'Affiliation': 'Department of Health Promotion, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Ramat Aviv, Tel Aviv 6997801, Israel.'}]",International journal of environmental research and public health,['10.3390/ijerph17103349']
720,30465010,Changes in Waist Circumference in HIV-Infected Individuals Initiating a Raltegravir or Protease Inhibitor Regimen: Effects of Sex and Race.,"Background


This study investigates the association of clinical and demographic predictors with abdominal fat gain, measured using waist circumference (WC) and self-reported abdominal size.
Methods


We analyzed data from ACTG A5257, a clinical trial that randomized treatment-naïve HIV-infected participants to 1 of 3 antiretroviral regimens: raltegravir (RAL) or the protease inhibitors (PIs) atazanavir/ritonavir (ATV/r) or darunavir/ritonavir (DRV/r), each in combination with tenofovir disoproxil fumarate/emtricitabine. Associations of treatment and baseline/demographic characteristics with 96-week WC change were assessed using repeated-measures models. Ordinal logistic regression was used to examine the associations of predictors with week 96 self-reported abdominal changes.
Results


The study population (n = 1809) was 76.0% male and predominantly black non-Hispanic (41.9%) and white non-Hispanic (34.1%). Mean baseline WC was 90.6 cm, with an average 96-week increase of 3.4 cm. WC increases were higher in the RAL arm compared with DRV/r ( P  = .0130). Females experienced greater increases in WC on RAL vs ATV/r than males ( P  = .0065). Similarly, a larger difference in WC change was found for RAL vs DRV/r for black vs nonblack individuals ( P  = .0043). A separate multivariable model found that in addition to the treatment regimen, higher baseline viral load and lower CD4+ were also associated with WC increases.
Conclusions


With antiretroviral therapy initiation, higher WC increases in the RAL arm compared with PIs were more pronounced in female and black participants, and a more advanced baseline HIV disease state was a strong predictor of larger abdominal increases. Understanding factors predisposing individuals to abdominal fat gain could inform health management after therapy initiation.",2018,WC increases were higher in the RAL arm compared with DRV/r ( P  = .0130).,"['naïve HIV-infected participants to 1 of 3 antiretroviral regimens', 'HIV-Infected Individuals', 'The study population (n = 1809) was 76.0% male and predominantly black non-Hispanic (41.9%) and white non-Hispanic (34.1']","['raltegravir (RAL) or the protease inhibitors (PIs) atazanavir/ritonavir (ATV/r) or darunavir/ritonavir (DRV/r), each in combination with tenofovir disoproxil fumarate/emtricitabine', 'Raltegravir or Protease Inhibitor Regimen']","['Waist Circumference', 'waist circumference (WC) and self-reported abdominal size', 'Mean baseline WC', 'WC change']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C1268897', 'cui_str': 'Product containing protease inhibitor'}, {'cui': 'C1145759', 'cui_str': 'Atazanavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}]","[{'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",1809.0,0.0834691,WC increases were higher in the RAL arm compared with DRV/r ( P  = .0130).,"[{'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Bhagwat', 'Affiliation': 'University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Ighovwerha', 'Initials': 'I', 'LastName': 'Ofotokun', 'Affiliation': 'Emory University School of Medicine, Department of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Grace A', 'Initials': 'GA', 'LastName': 'McComsey', 'Affiliation': 'Case Western University, Cleveland, Ohio.'}, {'ForeName': 'Todd T', 'Initials': 'TT', 'LastName': 'Brown', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Carlee', 'Initials': 'C', 'LastName': 'Moser', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Sugar', 'Affiliation': 'University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'University of California, Los Angeles, Los Angeles, California.'}]",Open forum infectious diseases,['10.1093/ofid/ofy201']
721,31660398,Atovaquone-Proguanil in Combination With Artesunate to Treat Multidrug-Resistant  P. falciparum  Malaria in Cambodia: An Open-Label Randomized Trial.,"Background


Recent artemisinin-combination therapy failures in Cambodia prompted a search for alternatives. Atovaquone-proguanil (AP), a safe, effective treatment for multidrug-resistant  Plasmodium falciparum  ( P.f. ), previously demonstrated additive effects in combination with artesunate (AS).
Methods


Patients with  P.f.  or mixed-species infection (n = 205) in Anlong Veng (AV; n = 157) and Kratie (KT; n = 48), Cambodia, were randomized open-label 1:1 to a fixed-dose 3-day AP regimen +/-3 days of co-administered artesunate (ASAP). Single low-dose primaquine (PQ, 15 mg) was given on day 1 to prevent gametocyte-mediated transmission.
Results


Polymerase chain reaction-adjusted adequate clinical and parasitological response at 42 days was 90% for AP (95% confidence interval [CI], 82%-95%) and 92% for ASAP (95% CI, 83%-96%;  P  = .73). The median parasite clearance time was 72 hours for ASAP in AV vs 56 hours in KT ( P  < .001) and was no different than AP alone. At 1 week postprimaquine, 7% of the ASAP group carried microscopic gametocytes vs 29% for AP alone ( P  = .0001). Nearly all  P.f.  isolates had C580Y K13 propeller artemisinin resistance mutations (AV 99%; KT 88%). Only 1 of 14 treatment failures carried the cytochrome bc1 (Pfcytb) atovaquone resistance mutation, which was not present at baseline.  P.f.  isolates remained atovaquone sensitive in vitro but cycloguanil resistant, with a triple  P.f.  dihydrofolate reductase mutation.
Conclusions


Atovaquone-proguanil remained marginally effective in Cambodia (≥90%) with minimal Pfcytb mutations observed. Treatment failures in the presence of ex vivo atovaquone sensitivity and adequate plasma levels may be attributable to cycloguanil and/or artemisinin resistance. Artesunate co-administration provided little additional blood-stage efficacy but reduced post-treatment gametocyte carriage in combination with AP beyond single low-dose primaquine.",2019,The median parasite clearance time was 72 hours for ASAP in AV vs 56 hours in KT ( P  < .001) and was no different than AP alone.,"['P. falciparum  Malaria in Cambodia', 'Methods\n\n\nPatients with  P.f.  or', 'mixed-species infection (n = 205) in Anlong Veng (AV; n = 157) and Kratie (KT; n = 48), Cambodia']","['artesunate (AS', 'fixed-dose 3-day AP regimen +/-3 days of co-administered artesunate (ASAP', 'Atovaquone-proguanil (AP', 'primaquine (PQ', 'primaquine', 'Atovaquone-Proguanil in Combination With Artesunate', 'ASAP']","['microscopic gametocytes', 'Polymerase chain reaction-adjusted adequate clinical and parasitological response', 'cytochrome bc1 (Pfcytb) atovaquone resistance mutation', 'additional blood-stage efficacy', 'median parasite clearance time', 'C580Y K13 propeller artemisinin resistance mutations']","[{'cui': 'C0024535', 'cui_str': 'Plasmodium falciparum Malaria'}, {'cui': 'C0006797', 'cui_str': 'Khmer Republic'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]","[{'cui': 'C0052432', 'cui_str': 'artesunate'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0052143', 'cui_str': 'AP protocol 1'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0939219', 'cui_str': 'Atovaquone / Proguanil'}, {'cui': 'C0033126', 'cui_str': 'Primaquine'}]","[{'cui': 'C0205288', 'cui_str': 'Microscopic (qualifier value)'}, {'cui': 'C0686869', 'cui_str': 'Gametocyte'}, {'cui': 'C0032520', 'cui_str': 'PCR'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205468', 'cui_str': 'Parasitologic (qualifier value)'}, {'cui': 'C0041535', 'cui_str': 'Cytochrome bc1'}, {'cui': 'C0165603', 'cui_str': 'Atovaquone'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0005768'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0521066', 'cui_str': 'parasites'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1136174', 'cui_str': 'Artemisinins'}]",,0.17852,The median parasite clearance time was 72 hours for ASAP in AV vs 56 hours in KT ( P  < .001) and was no different than AP alone.,"[{'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Wojnarski', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Chanthap', 'Initials': 'C', 'LastName': 'Lon', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Pattaraporn', 'Initials': 'P', 'LastName': 'Vanachayangkul', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Panita', 'Initials': 'P', 'LastName': 'Gosi', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Somethy', 'Initials': 'S', 'LastName': 'Sok', 'Affiliation': 'Department of Health, Ministry of National Defense, Phnom Penh, Cambodia.'}, {'ForeName': 'Agus', 'Initials': 'A', 'LastName': 'Rachmat', 'Affiliation': 'Naval Medical Research Unit-2, Phnom Penh, Cambodia.'}, {'ForeName': 'Dustin', 'Initials': 'D', 'LastName': 'Harrison', 'Affiliation': 'Naval Medical Research Unit-2, Phnom Penh, Cambodia.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Berjohn', 'Affiliation': 'Naval Medical Research Unit-2, Phnom Penh, Cambodia.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Spring', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Suwanna', 'Initials': 'S', 'LastName': 'Chaoratanakawee', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Mali', 'Initials': 'M', 'LastName': 'Ittiverakul', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Nillawan', 'Initials': 'N', 'LastName': 'Buathong', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Soklyda', 'Initials': 'S', 'LastName': 'Chann', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Saowaluk', 'Initials': 'S', 'LastName': 'Wongarunkochakorn', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Andreea', 'Initials': 'A', 'LastName': 'Waltmann', 'Affiliation': 'Henry M. Jackson Foundation, Bethesda, Maryland.'}, {'ForeName': 'Worachet', 'Initials': 'W', 'LastName': 'Kuntawunginn', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Fukuda', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Burkly', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Vireak', 'Initials': 'V', 'LastName': 'Heang', 'Affiliation': 'Naval Medical Research Unit-2, Phnom Penh, Cambodia.'}, {'ForeName': 'Thay Keang', 'Initials': 'TK', 'LastName': 'Heng', 'Affiliation': 'National Center for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia.'}, {'ForeName': 'Nareth', 'Initials': 'N', 'LastName': 'Kong', 'Affiliation': 'National Center for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia.'}, {'ForeName': 'Threechada', 'Initials': 'T', 'LastName': 'Boonchan', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Bolin', 'Initials': 'B', 'LastName': 'Chum', 'Affiliation': 'Naval Medical Research Unit-2, Phnom Penh, Cambodia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Smith', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Vaughn', 'Affiliation': 'Naval Medical Research Unit-2, Phnom Penh, Cambodia.'}, {'ForeName': 'Satharath', 'Initials': 'S', 'LastName': 'Prom', 'Affiliation': 'Department of Health, Ministry of National Defense, Phnom Penh, Cambodia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Division of Infectious Diseases, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Dysoley', 'Initials': 'D', 'LastName': 'Lek', 'Affiliation': 'National Center for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Saunders', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}]",Open forum infectious diseases,['10.1093/ofid/ofz314']
722,31649304,Characterization and prediction of acute and sustained response to psychedelic psilocybin in a mindfulness group retreat.,"Meditation and psychedelics have played key roles in humankind's search for self-transcendence and personal change. However, neither their possible synergistic effects, nor related state and trait predictors have been experimentally studied. To elucidate these issues, we administered double-blind the model psychedelic drug psilocybin (315 μg/kg PO) or placebo to meditators (n = 39) during a 5-day mindfulness group retreat. Psilocybin increased meditation depth and incidence of positively experienced self-dissolution along the perception-hallucination continuum, without concomitant anxiety. Openness, optimism, and emotional reappraisal were predictors of the acute response. Compared with placebo, psilocybin enhanced post-intervention mindfulness and produced larger positive changes in psychosocial functioning at a 4-month follow-up, which were corroborated by external ratings, and associated with magnitude of acute self-dissolution experience. Meditation seems to enhance psilocybin's positive effects while counteracting possible dysphoric responses. These findings highlight the interactions between non-pharmacological and pharmacological factors, and the role of emotion/attention regulation in shaping the experiential quality of psychedelic states, as well as the experience of selflessness as a modulator of behavior and attitudes. A better comprehension of mechanisms underlying most beneficial psychedelic experiences may guide therapeutic interventions across numerous mental conditions in the form of psychedelic-assisted applications.",2019,"Compared with placebo, psilocybin enhanced post-intervention mindfulness and produced larger positive changes in psychosocial functioning at a 4-month follow-up, which were corroborated by external ratings, and associated with magnitude of acute self-dissolution experience.",[],"['placebo', 'Psilocybin', 'placebo, psilocybin', 'psychedelic psilocybin']","['Openness, optimism, and emotional reappraisal', 'psychosocial functioning', 'meditation depth and incidence of positively experienced self-dissolution']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033850', 'cui_str': 'Psilocybin'}, {'cui': 'C0018533', 'cui_str': 'Psychedelic Agents'}]","[{'cui': 'C0547049', 'cui_str': 'Openness (qualifier value)'}, {'cui': 'C0237428', 'cui_str': 'Optimism'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0150277'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",,0.0515426,"Compared with placebo, psilocybin enhanced post-intervention mindfulness and produced larger positive changes in psychosocial functioning at a 4-month follow-up, which were corroborated by external ratings, and associated with magnitude of acute self-dissolution experience.","[{'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Smigielski', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Lenggstrasse 31, CH-8032, Zurich, Switzerland. lu.smigielski@gmail.com.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kometer', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Lenggstrasse 31, CH-8032, Zurich, Switzerland.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Scheidegger', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Lenggstrasse 31, CH-8032, Zurich, Switzerland.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Krähenmann', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Lenggstrasse 31, CH-8032, Zurich, Switzerland.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Huber', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Lenggstrasse 31, CH-8032, Zurich, Switzerland.'}, {'ForeName': 'Franz X', 'Initials': 'FX', 'LastName': 'Vollenweider', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Lenggstrasse 31, CH-8032, Zurich, Switzerland.'}]",Scientific reports,['10.1038/s41598-019-50612-3']
723,31811686,Young children are more likely to cheat after overhearing that a classmate is smart.,"Research on moral socialization has largely focused on the role of direct communication and has almost completely ignored a potentially rich source of social influence: evaluative comments that children overhear. We examined for the first time whether overheard comments can shape children's moral behavior. Three- and 5-year-old children (N = 200) participated in a guessing game in which they were instructed not to cheat by peeking. We randomly assigned children to a condition in which they overheard an experimenter tell another adult that a classmate who was no longer present is smart, or to a control condition in which the overheard conversation consisted of non-social information. We found that 5-year-olds, but not 3-year-olds, cheated significantly more often if they overheard the classmate praised for being smart. These findings show that the effects of ability praise can spread far beyond the intended recipient to influence the behavior of children who are mere observers, and they suggest that overheard evaluative comments can be an important force in shaping moral development.",2020,"We found that 5-year-olds, but not 3-year-olds, cheated significantly more often if they overheard the classmate praised for being smart.","['Three- and 5-year-old children (N\xa0=\xa0200) participated in a guessing game in which they were instructed not to cheat by peeking', 'Young children']","['condition in which they overheard an experimenter tell another adult that a classmate who was no longer present is smart, or to a control condition in which the overheard conversation consisted of non-social information']",[],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]",[],,0.0291003,"We found that 5-year-olds, but not 3-year-olds, cheated significantly more often if they overheard the classmate praised for being smart.","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Institute of Psychological Sciences, Hangzhou Normal University, Hangzhou, PR China.'}, {'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Institute of Psychological Sciences, Hangzhou Normal University, Hangzhou, PR China.'}, {'ForeName': 'Wenjin', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Institute of Psychological Sciences, Hangzhou Normal University, Hangzhou, PR China.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Compton', 'Affiliation': 'Institute of Psychological Sciences, Hangzhou Normal University, Hangzhou, PR China.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Dr Eric Jackman Institute of Child Study, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Gail D', 'Initials': 'GD', 'LastName': 'Heyman', 'Affiliation': 'Department of Psychology, University of California San Diego, La Jolla, CA, USA.'}]",Developmental science,['10.1111/desc.12930']
724,30593701,Effectiveness of a protocol for teaching dental tooth color in students with color vision impairment.,"OBJECTIVE


In patients with color vision alterations (CVA), the correct determination of color is altered, but not the detection of changes in luminosity or value. There is no accepted training protocol for dental value selection in dental students with CVA. The objective of this pilot study was to determine the effectiveness of a dental color training protocol based on the dental value selection.
MATERIALS AND METHODS


An intervention study was carried out on dental students in a University setting, applying a specific dental color training protocol on two groups of students. Group 1:4 students with CVA, Group 2:4 healthy students. A third group of four students without intervention was used as a control group. An initial diagnostic test was applied, which was reapplied at the end of the training.
RESULTS


The number of errors in the selection of the dental color decreased after training in all three groups, P > .05. For the value parameter, there was a statistically significant decrease in the number of errors after training (P = .014).
CONCLUSIONS


The applied training protocol could be of help in students with CVA, but multicenter studies are needed.
CLINICAL SIGNIFICANCE


Level 3 evidence level.",2020,"The number of errors in the selection of the dental color decreased after training in all three groups, P > .05.","['dental students in a University setting, applying a specific dental color training protocol on two groups of students', 'patients with color vision alterations (CVA', 'dental students with CVA', 'students with color vision impairment', 'Group 1:4 students with CVA, Group 2:4 healthy students']",['dental color training protocol'],"['number of errors', 'number of errors in the selection of the dental color']","[{'cui': 'C0038493', 'cui_str': 'Students, Dental'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0522507', 'cui_str': 'With color (attribute)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]","[{'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0009393', 'cui_str': 'Color'}]",4.0,0.0170751,"The number of errors in the selection of the dental color decreased after training in all three groups, P > .05.","[{'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Wagner', 'Affiliation': 'School of Dentistry, Faculty of Medicine, Pontificia Universidad Católica de Chile, Macul, Santiago, Chile.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Rioseco', 'Affiliation': 'School of Dentistry, Faculty of Medicine, Pontificia Universidad Católica de Chile, Macul, Santiago, Chile.'}, {'ForeName': 'Duniel', 'Initials': 'D', 'LastName': 'Ortuño', 'Affiliation': 'School of Dentistry, Faculty of Medicine, Pontificia Universidad Católica de Chile, Macul, Santiago, Chile.'}, {'ForeName': 'María F', 'Initials': 'MF', 'LastName': 'Cortés', 'Affiliation': 'School of Dentistry, Faculty of Medicine, Pontificia Universidad Católica de Chile, Macul, Santiago, Chile.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Costa', 'Affiliation': 'School of Dentistry, Faculty of Medicine, Pontificia Universidad Católica de Chile, Macul, Santiago, Chile.'}]",Journal of esthetic and restorative dentistry : official publication of the American Academy of Esthetic Dentistry ... [et al.],['10.1111/jerd.12451']
725,31661339,"Early induction intensification with cladribine, cytarabine, and mitoxantrone (CLAM) in AML patients treated with the DAC induction regimen: a prospective, non-randomized, phase II study of the Polish Adult Leukemia Group (PALG).","We present the results of a prospective, non-randomized phase 2 trial in which 253 AML patients (pts) under 60 years old received DAC (Daunorubicin + AraC + Cladribine) as first induction followed by CLAM (Cladribine + AraC + Mitoxantrone) as early second induction on day 16 based on bone marrow (BM) blasts on day 14 (D14). The CR/CRi rate after a single course of DAC was 83% for pts with D14 BM blasts less than 10%. Forty-six pts had >10% BM blasts on D14, of whom 35 received CLAM with rates of CR/CRi 60% and early death (ED) 23%. The remaining 11 pts were not fit to receive CLAM, with rates of CR/CRi 28%, PR 18%, and ED 18%. Median OS was 7.2 versus 7.5 months, respectively. The overall CR/CRi rate was 77% after the first induction, with final CR/CRi rate 80% after DAC reinduction for pts who achieved PR with initial DAC course. CLAM used as early second induction might improve CR/CRi rates for younger AML pts with poor early response to DAC induction, but may be associated with higher mortality.",2020,"CLAM used as early second induction might improve CR/CRi rates for younger AML pts with poor early response to DAC induction, but may be associated with higher mortality.","['AML patients treated with the DAC induction regimen: a prospective, non-randomized, phase II study of the Polish Adult Leukemia Group (PALG', '253 AML patients (pts) under 60\u2009years old received']","['cladribine, cytarabine, and mitoxantrone (CLAM', 'CLAM (Cladribine\u2009+\u2009AraC\u2009+\u2009Mitoxantrone', 'DAC (Daunorubicin\u2009+\u2009AraC\u2009+\u2009Cladribine', 'CLAM']","['Median OS', 'CR/CRi rates', 'overall CR/CRi rate', 'CR/CRi rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032377', 'cui_str': 'Polishes'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0092801', 'cui_str': 'Cladribine'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C0008894', 'cui_str': 'Clams'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",253.0,0.015683,"CLAM used as early second induction might improve CR/CRi rates for younger AML pts with poor early response to DAC induction, but may be associated with higher mortality.","[{'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Pluta', 'Affiliation': 'Department of Hematology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Robak', 'Affiliation': 'Department of Hematology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Kamil', 'Initials': 'K', 'LastName': 'Brzozowski', 'Affiliation': 'Department of Hematology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Stepka', 'Affiliation': 'Department of Hematology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Wawrzyniak', 'Affiliation': 'Department of Hematology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Krawczynska', 'Affiliation': 'Department of Hematology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Czemerska', 'Affiliation': 'Department of Hematology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Szmigielska-Kaplon', 'Affiliation': 'Department of Hematology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Grzybowska-Izydorczyk', 'Affiliation': 'Department of Hematology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Mateusz', 'Initials': 'M', 'LastName': 'Nowicki', 'Affiliation': 'Department of Hematology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Stelmach', 'Affiliation': 'Department of Hematology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Kuydowicz', 'Affiliation': 'Department of Hematology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Gromek', 'Affiliation': 'Department of Hematooncology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Hus', 'Affiliation': 'Department of Hematooncology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Helbig', 'Affiliation': 'Department of Hematology and BMT, Medical School of Silesia, Katowice, Poland.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Grosicki', 'Affiliation': 'Department of Cancer Prevention, School of Public Health, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Bodzenta', 'Affiliation': 'Department of Hematology, Municipal Hospital, Chorzow, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Razny', 'Affiliation': 'Hematology Department, Rydygier Memorial Hospital, Krakow, Poland.'}, {'ForeName': 'Karol', 'Initials': 'K', 'LastName': 'Wojcik', 'Affiliation': 'Hematology Department, Rydygier Memorial Hospital, Krakow, Poland.'}, {'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Bolkun', 'Affiliation': 'Department of Hematology, Medical University Hospital, Bialystok, Poland.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Kloczko', 'Affiliation': 'Department of Hematology, Medical University Hospital, Bialystok, Poland.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Knopinska-Posluszny', 'Affiliation': 'Hematology Department, Hospital MSWiA, Olsztyn, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Piekarska', 'Affiliation': 'Department of Hematology, Transplantation Medical University of Gdansk, Gdansk, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Hellman', 'Affiliation': 'Department of Hematology, Transplantation Medical University of Gdansk, Gdansk, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Sobas', 'Affiliation': 'Department of Hematology, Blood Neoplasm and Bone Marrow Transplantation, Wroclaw, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Wrobel', 'Affiliation': 'Department of Hematology, Blood Neoplasm and Bone Marrow Transplantation, Wroclaw, Poland.'}, {'ForeName': 'Elzbieta', 'Initials': 'E', 'LastName': 'Patkowska', 'Affiliation': 'Department of Hematology, Institute of Hematology and Transfusion Medicine, Warsaw, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Lech-Maranda', 'Affiliation': 'Department of Hematology, Institute of Hematology and Transfusion Medicine, Warsaw, Poland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Warzocha', 'Affiliation': 'Department of Hematology, Institute of Hematology and Transfusion Medicine, Warsaw, Poland.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Holowiecki', 'Affiliation': 'Department of Bone Marrow Transplantation and Onco-Hematology, Maria Sklodowska-Curie Institute - Cancer Center, Gliwice Branch, Gliwice, Poland.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Giebel', 'Affiliation': 'Department of Bone Marrow Transplantation and Onco-Hematology, Maria Sklodowska-Curie Institute - Cancer Center, Gliwice Branch, Gliwice, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Wierzbowska', 'Affiliation': 'Department of Hematology, Medical University of Lodz, Lodz, Poland.'}]",Leukemia & lymphoma,['10.1080/10428194.2019.1678151']
726,31369355,Impact of transitional care for discharged elderly stroke patients in China: an application of the Integrated Behavioral Model.,"Background : Transitional care (TC) has been shown to improve stroke rehabilitation in discharged stroke patients. Previous TC interventions did not report satisfactory stroke rehabilitation outcomes or risk management. Incorporating a health behavior theory in interventions can effectively improve health behaviors and metabolic indicators. Objectives : This study was a clinical controlled trial to investigate the impact of the Integrated Behavioral Model (IBM)-based 3-month TC on health behaviors, clinical outcomes, and stroke knowledge in discharged elderly stroke patients. Methods : Sixty elderly patients were recruited from two wards of a public teaching hospital in China. To prevent potential treatment contamination, patients were allocated into either a control or intervention group depending on which wards they were admitted to. The TC intervention considered all the IBM constructs to provide patients assistance in implementing health behaviors as recommended by the Chinese stroke guidelines. The TC intervention commenced one day before discharge and lasted three months after discharge. A linear mixed model was used to measure the impact of the intervention. Results : The TC intervention improved the discharged elderly stroke patients' health behaviors, activities of daily living, quality of life, and stroke knowledge. The intervention also controlled the patients' systolic blood pressure, body mass index, total cholesterol, triglycerides, and low-density lipoprotein cholesterol. Conclusions : This study provided evidence of concurrent self-reported and objective clinical indicators in discharged elderly stroke patients for the impact of the IBM-based 3-month TC intervention, which can be recommended for clinical practice.",2019,"The TC intervention improved the discharged elderly stroke patients' health behaviors, activities of daily living, quality of life, and stroke knowledge.","['discharged stroke patients', 'discharged elderly stroke patients', 'discharged elderly stroke patients in China', 'Sixty elderly patients were recruited from two wards of a public teaching hospital in China']","['Transitional care (TC', 'Integrated Behavioral Model (IBM)-based 3-month TC', ' ', 'IBM-based 3-month TC intervention', 'TC intervention']","[""discharged elderly stroke patients' health behaviors, activities of daily living, quality of life, and stroke knowledge"", 'health behaviors and metabolic indicators', 'health behaviors, clinical outcomes, and stroke knowledge', 'systolic blood pressure, body mass index, total cholesterol, triglycerides, and low-density lipoprotein cholesterol']","[{'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}]","[{'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018687'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0034380'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}]",60.0,0.0220432,"The TC intervention improved the discharged elderly stroke patients' health behaviors, activities of daily living, quality of life, and stroke knowledge.","[{'ForeName': 'Guiling', 'Initials': 'G', 'LastName': 'Geng', 'Affiliation': ""School of Nursing, Nantong University, Nantong City, Jiangsu Province, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'He', 'Affiliation': ""School of Nursing, Nantong University, Nantong City, Jiangsu Province, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': ""School of Nursing, Nantong University, Nantong City, Jiangsu Province, People's Republic of China.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Klug', 'Affiliation': 'School of Nursing, Queensland University of Technology, Kelvin Grove, Queensland, Australia.'}, {'ForeName': 'Yuhua', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': ""Department of Nursing, The Second People's Hospital of Nantong City, Nantong City, Jiangsu Province, People's Republic of China.""}]",Topics in stroke rehabilitation,['10.1080/10749357.2019.1647650']
727,30563758,Efficacy of mandibular manipulation technique for temporomandibular disorders patients with mouth opening limitation: a randomized controlled trial for comparison with improved multimodal therapy.,"PURPOSE


Manual therapy has been used for the treatment of patients with temporomandibular disorders (TMD) with mouth-opening limitations. However, the curative effect of manipulation differs among researchers, and its necessity remains controversial. The purpose of this study was to confirm the efficacy of manipulation using a randomized controlled trial (RCT).
METHODS


A total of 61 TMD patients who had mouth-opening limitation (upper and lower middle incisor distance ≤35mm) were selected. They were divided into two treatment groups: conventional treatment (n=30) and conventional treatment plus manipulation (n=31). The conventional treatment included two types of self-exercise: cognitive behavioral therapy for bruxism and education. Mouth-opening limitation, orofacial pain, and temporomandibular joint (TMJ) sounds were recorded from baseline to 18 weeks after baseline. These parameters were statistically compared between the two treatment groups by using analysis of variance (ANOVA) and Scheffe's test to assess mouth opening distance and pain; TMJ sounds were compared using Mann-Whitney U test.
RESULTS


No statistical difference was observed between the two treatment groups except for mouth-opening limitation after treatment at the first visit. Subgroup analyses, stratified according to the pathological type of TMD, indicated a similar trend.
CONCLUSIONS


The efficacy of manipulation seems to be limited, in contrast to our expectations, and improved execution of therapeutic exercises has a similar effect to that of manipulation during long-term observation. The advantage of manipulation was observed only during the first treatment session. The RCT was registered in the University Hospital Medical Information Network in Japan (UMIN-CTR: 000010437).",2019,"Mouth-opening limitation, orofacial pain, and temporomandibular joint (TMJ) sounds were recorded from baseline to 18 weeks after baseline.","['61 TMD patients who had mouth-opening limitation (upper and lower middle incisor distance ≤35mm', 'temporomandibular disorders patients with mouth opening limitation', 'patients with temporomandibular disorders (TMD) with mouth-opening limitations']","['conventional treatment (n=30) and conventional treatment plus manipulation', 'multimodal therapy', 'self-exercise: cognitive behavioral therapy for bruxism and education', 'mandibular manipulation technique']","['Mouth-opening limitation, orofacial pain, and temporomandibular joint (TMJ) sounds', 'mouth-opening limitation', 'mouth opening distance and pain; TMJ sounds', 'advantage of manipulation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021156', 'cui_str': 'Incisor'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0039494', 'cui_str': 'TMJ Diseases'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0006325', 'cui_str': 'Teeth Grinding Disorder'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0178782', 'cui_str': 'Orofacial Pain'}, {'cui': 'C0039493', 'cui_str': 'TMJ'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}]",61.0,0.0693357,"Mouth-opening limitation, orofacial pain, and temporomandibular joint (TMJ) sounds were recorded from baseline to 18 weeks after baseline.","[{'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Nagata', 'Affiliation': 'Temporomandibular Disorders and Bruxism Clinic, Niigata Hospital, The Nippon Dental University, Niigata, Japan. Electronic address: nagata@ngt.ndu.ac.jp.'}, {'ForeName': 'Satol', 'Initials': 'S', 'LastName': 'Hori', 'Affiliation': 'Temporomandibular Disorders and Bruxism Clinic, Niigata Hospital, The Nippon Dental University, Niigata, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Mizuhashi', 'Affiliation': 'Temporomandibular Disorders and Bruxism Clinic, Niigata Hospital, The Nippon Dental University, Niigata, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Yokoe', 'Affiliation': 'Temporomandibular Disorders and Bruxism Clinic, Niigata Hospital, The Nippon Dental University, Niigata, Japan.'}, {'ForeName': 'Yojiro', 'Initials': 'Y', 'LastName': 'Atsumi', 'Affiliation': 'Temporomandibular Disorders and Bruxism Clinic, Niigata Hospital, The Nippon Dental University, Niigata, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Nagai', 'Affiliation': 'Temporomandibular Disorders and Bruxism Clinic, Niigata Hospital, The Nippon Dental University, Niigata, Japan.'}, {'ForeName': 'Motoatu', 'Initials': 'M', 'LastName': 'Goto', 'Affiliation': 'Temporomandibular Disorders and Bruxism Clinic, Niigata Hospital, The Nippon Dental University, Niigata, Japan.'}]",Journal of prosthodontic research,['10.1016/j.jpor.2018.11.010']
728,32408692,The Wildman Programme. A Nature-Based Rehabilitation Programme Enhancing Quality of Life for Men on Long-Term Sick Leave: Study Protocol for a Matched Controlled Study In Denmark.,"Many men have poor mental health and need help to recover. However, designing a rehabilitation intervention that appeals to men is challenging. This study protocol aims to describe the 'Wildman Programme', which will be a nature-based rehabilitation programme for men on long-term sick leave due to health problems such as stress, anxiety, depression, post-cancer and chronic cancer, chronic obstructive pulmonary disease (COPD), cardiovascular disease, or diabetes type II. The programme will be a nature-based rehabilitation initiative combining nature experiences, attention training, body awareness training, and supporting community spirit. The aim of the study will be to examine whether the 'Wildman Programme' can help to increase quality of life and reduce stress among men with health problems compared to treatment as usual. The study will be a matched control study where an intervention group (number of respondents,  N  = 52) participating in a 12-week nature-based intervention will be compared to a control group ( N  = 52) receiving treatment as usual. Outcomes are measured at baseline (T1), post-treatment (T2), and at follow up 6 months post-intervention (T3). The results of this study will be important to state whether the method in the 'Wildman Programme' can be implemented as a rehabilitation offer in the Danish Healthcare System to help men with different health problems.",2020,The aim of the study will be to examine whether the 'Wildman Programme' can help to increase quality of life and reduce stress among men with health problems compared to treatment as usual.,['men with health problems'],['control group ( N  = 52) receiving treatment as usual'],"['quality of life and reduce stress', 'Quality of Life']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",52.0,0.0257458,The aim of the study will be to examine whether the 'Wildman Programme' can help to increase quality of life and reduce stress among men with health problems compared to treatment as usual.,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Høegmark', 'Affiliation': 'Department of Psychology, University of Southern Denmark, 5230 Odense M, Denmark.'}, {'ForeName': 'Tonny Elmose', 'Initials': 'TE', 'LastName': 'Andersen', 'Affiliation': 'Department of Psychology, University of Southern Denmark, 5230 Odense M, Denmark.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Grahn', 'Affiliation': 'Department of Work Science, Business Economics and Environmental Psychology, Swedish University of Agricultural Sciences, SE-230 53 Alnarp, Sweden.'}, {'ForeName': 'Kirsten Kaya', 'Initials': 'KK', 'LastName': 'Roessler', 'Affiliation': 'Department of Psychology, University of Southern Denmark, 5230 Odense M, Denmark.'}]",International journal of environmental research and public health,['10.3390/ijerph17103368']
729,27000311,Dietary supplements for dysmenorrhoea.,"BACKGROUND


Dysmenorrhoea refers to painful menstrual cramps and is a common gynaecological complaint. Conventional treatments include non-steroidal anti-inflammatory drugs (NSAIDs) and oral contraceptive pills (OCPs), which both reduce myometrial activity (contractions of the uterus). A suggested alternative approach is dietary supplements. We used the term 'dietary supplement' to include herbs or other botanical, vitamins, minerals, enzymes, and amino acids. We excluded traditional Chinese medicines.
OBJECTIVES


To determine the efficacy and safety of dietary supplements for treating dysmenorrhoea.
SEARCH METHODS


We searched sources including the Cochrane Gynaecology and Fertility Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, AMED, PsycINFO (all from inception to 23 March 2015), trial registries, and the reference lists of relevant articles.
SELECTION CRITERIA


We included randomised controlled trials (RCTs) of dietary supplements for moderate or severe primary or secondary dysmenorrhoea. We excluded studies of women with an intrauterine device. Eligible comparators were other dietary supplements, placebo, no treatment, or conventional analgesia.
DATA COLLECTION AND ANALYSIS


Two review authors independently performed study selection, performed data extraction and assessed the risk of bias in the included trials. The primary outcomes were pain intensity and adverse effects. We used a fixed-effect model to calculate odds ratios (ORs) for dichotomous data, and mean differences (MDs) or standardised mean differences (SMDs) for continuous data, with 95% confidence intervals (CIs). We presented data that were unsuitable for analysis either descriptively or in additional tables. We assessed the quality of the evidence using Grading of Recommendations Assessment, Development and Evaluation (GRADE) methods.
MAIN RESULTS


We included 27 RCTs (3101 women). Most included studies were conducted amongst cohorts of students with primary dysmenorrhoea in their late teens or early twenties. Twenty-two studies were conducted in Iran and the rest were performed in other middle-income countries. Only one study addressed secondary dysmenorrhoea. Interventions included 12 different herbal medicines (German chamomile (Matricaria chamomilla, M recutita, Chamomilla recutita), cinnamon (Cinnamomum zeylanicum, C. verum), Damask rose (Rosa damascena), dill (Anethum graveolens), fennel (Foeniculum vulgare), fenugreek (Trigonella foenum-graecum), ginger (Zingiber officinale), guava (Psidium guajava), rhubarb (Rheum emodi), uzara (Xysmalobium undulatum), valerian (Valeriana officinalis), and zataria (Zataria multiflora)) and five non-herbal supplements (fish oil, melatonin, vitamins B1 and E, and zinc sulphate) in a variety of formulations and doses. Comparators included other supplements, placebo, no treatment, and NSAIDs.We judged all the evidence to be of low or very low quality. The main limitations were imprecision due to very small sample sizes, failure to report study methods, and inconsistency. For most comparisons there was only one included study, and very few studies reported adverse effects. Effectiveness of supplements for primary dysmenorrhoea We have presented pain scores (all on a visual analogue scale (VAS) 0 to 10 point scale) or rates of pain relief, or both, at the first post-treatment follow-up. Supplements versus placebo or no treatmentThere was no evidence of effectiveness for vitamin E (MD 0.00 points, 95% CI -0.34 to 0.34; two RCTs, 135 women).There was no consistent evidence of effectiveness for dill (MD -1.15 points, 95% CI -2.22 to -0.08, one RCT, 46 women), guava (MD 0.59, 95% CI -0.13 to 1.31; one RCT, 151 women); one RCT, 73 women), or fennel (MD -0.34 points, 95% CI -0.74 to 0.06; one RCT, 43 women).There was very limited evidence of effectiveness for fenugreek (MD -1.71 points, 95% CI -2.35 to -1.07; one RCT, 101 women), fish oil (MD 1.11 points, 95% CI 0.45 to 1.77; one RCT, 120 women), fish oil plus vitamin B1 (MD -1.21 points, 95% CI -1.79 to -0.63; one RCT, 120 women), ginger (MD -1.55 points, 95% CI -2.43 to -0.68; three RCTs, 266 women; OR 5.44, 95% CI 1.80 to 16.46; one RCT, 69 women), valerian (MD -0.76 points, 95% CI -1.44 to -0.08; one RCT, 100 women), vitamin B1 alone (MD -2.70 points, 95% CI -3.32 to -2.08; one RCT, 120 women), zataria (OR 6.66, 95% CI 2.66 to 16.72; one RCT, 99 women), and zinc sulphate (MD -0.95 points, 95% CI -1.54 to -0.36; one RCT, 99 women).Data on chamomile and cinnamon versus placebo were unsuitable for analysis. Supplements versus NSAIDSThere was no evidence of any difference between NSAIDs and dill (MD 0.13 points, 95% CI -1.01 to 1.27; one RCT, 47 women), fennel (MD -0.70 points, 95% CI -1.81 to 0.41; one RCT, 59 women), guava (MD 1.19, 95% CI 0.42 to 1.96; one RCT, 155 women), rhubarb (MD -0.20 points, 95% CI -0.44 to 0.04; one RCT, 45 women), or valerian (MD points 0.62 , 95% CI 0.03 to 1.21; one RCT, 99 women),There was no consistent evidence of a difference between Damask rose and NSAIDs (MD -0.15 points, 95% CI -0.55 to 0.25; one RCT, 92 women).There was very limited evidence that chamomile was more effective than NSAIDs (MD -1.42 points, 95% CI -1.69 to -1.15; one RCT, 160 women). Supplements versus other supplementsThere was no evidence of a difference in effectiveness between ginger and zinc sulphate (MD 0.02 points, 95% CI -0.58 to 0.62; one RCT, 101 women). Vitamin B1 may be more effective than fish oil (MD -1.59 points, 95% CI -2.25 to -0.93; one RCT, 120 women). Effectiveness of supplements for secondary dysmenorrhoea There was no strong evidence of benefit for melatonin compared to placebo for dysmenorrhoea secondary to endometriosis (data were unsuitable for analysis). Safety of supplements Only four of the 27 included studies reported adverse effects in both treatment groups. There was no evidence of a difference between the groups but data were too scanty to reach any conclusions about safety.
AUTHORS' CONCLUSIONS


There is no high quality evidence to support the effectiveness of any dietary supplement for dysmenorrhoea, and evidence of safety is lacking. However for several supplements there was some low quality evidence of effectiveness and more research is justified.",2016,Effectiveness of supplements for secondary dysmenorrhoea There was no strong evidence of benefit for melatonin compared to placebo for dysmenorrhoea secondary to endometriosis (data were unsuitable for analysis).,"['students with primary dysmenorrhoea in their late teens or early twenties', 'women with an intrauterine device', 'Twenty-two studies were conducted in Iran and the rest were performed in other middle-income countries', '27 RCTs (3101 women', 'moderate or severe primary or secondary dysmenorrhoea']","['herbal medicines (German chamomile (Matricaria chamomilla, M recutita, Chamomilla recutita), cinnamon (Cinnamomum zeylanicum, C. verum', 'melatonin', 'placebo', ""dietary supplement' to include herbs or other botanical, vitamins, minerals, enzymes, and amino acids"", 'dietary supplements', 'NSAIDs ', 'zinc sulphate', 'Vitamin B1', 'Dietary supplements', 'dietary supplements, placebo, no treatment, or conventional analgesia', 'Conventional treatments include non-steroidal anti-inflammatory drugs (NSAIDs) and oral contraceptive pills (OCPs']","['zinc sulphate', 'adverse effects', 'effectiveness for vitamin E', 'pain scores', 'pain intensity and adverse effects', 'Damask rose (Rosa damascena), dill (Anethum graveolens), fennel (Foeniculum vulgare), fenugreek (Trigonella foenum-graecum), ginger (Zingiber officinale), guava (Psidium guajava), rhubarb (Rheum emodi), uzara (Xysmalobium undulatum), valerian (Valeriana officinalis), and zataria (Zataria multiflora)) and five non-herbal supplements (fish oil, melatonin, vitamins B1 and E, and zinc sulphate', 'visual analogue scale (VAS) 0 to 10 point scale) or rates of pain relief']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea (disorder)'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C3715212', 'cui_str': '20'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021900', 'cui_str': 'Contraceptive Devices, Intrauterine'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0232944', 'cui_str': 'Secondary dysmenorrhea (disorder)'}]","[{'cui': 'C2240391', 'cui_str': 'Herbal medicine (product)'}, {'cui': 'C1510478', 'cui_str': 'Matricaria chamomilla'}, {'cui': 'C1112857', 'cui_str': 'Cinnamon'}, {'cui': 'C0008802', 'cui_str': 'Cinnamomum verum'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0019240', 'cui_str': 'Herb (substance)'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0078794', 'cui_str': 'Zinc Sulfate'}, {'cui': 'C0373727', 'cui_str': 'Vitamin B-1 measurement'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0029151', 'cui_str': 'Oral contraception (finding)'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}]","[{'cui': 'C0078794', 'cui_str': 'Zinc Sulfate'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C1457892', 'cui_str': 'Dill Plant'}, {'cui': 'C1138843', 'cui_str': 'Fennel'}, {'cui': 'C0553175', 'cui_str': 'Foeniculum vulgare'}, {'cui': 'C0936126', 'cui_str': 'fenugreek seed meal'}, {'cui': 'C0060207', 'cui_str': 'Poenumgraecum'}, {'cui': 'C1879327', 'cui_str': 'Zingiber officinale'}, {'cui': 'C0453279', 'cui_str': 'Guava'}, {'cui': 'C0553399', 'cui_str': 'Psidium guajava'}, {'cui': 'C0035509', 'cui_str': 'Rhubarb'}, {'cui': 'C0035431', 'cui_str': 'Rheum'}, {'cui': 'C0042281', 'cui_str': 'Valeriana'}, {'cui': 'C1504473', 'cui_str': 'Herbal Supplements'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0373727', 'cui_str': 'Vitamin B-1 measurement'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0222045'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",3101.0,0.624177,Effectiveness of supplements for secondary dysmenorrhoea There was no strong evidence of benefit for melatonin compared to placebo for dysmenorrhoea secondary to endometriosis (data were unsuitable for analysis).,"[{'ForeName': 'Porjai', 'Initials': 'P', 'LastName': 'Pattanittum', 'Affiliation': 'Department of Biostatistics and Demography, Faculty of Public Health, Khon Kaen University, Mitraparp Road, Mueng District, Khon Kaen, Khon Kaen, Thailand, 40002.'}, {'ForeName': 'Naowarat', 'Initials': 'N', 'LastName': 'Kunyanone', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Ussanee S', 'Initials': 'US', 'LastName': 'Sangkomkamhang', 'Affiliation': ''}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Barnes', 'Affiliation': ''}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Seyfoddin', 'Affiliation': ''}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Marjoribanks', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD002124.pub2']
730,30528516,"Changes in aqueous oxidative stress, prostaglandins, and cytokines: Comparisons of low-energy femtosecond laser-assisted cataract surgery versus conventional phacoemulsification.","PURPOSE


To compare the aqueous oxidative stress, prostaglandin E 2  (PGE 2 ), and cytokine levels after low-energy femtosecond laser-assisted cataract surgery versus conventional phacoemulsification, and to evaluate the effect of a nonsteroidal antiinflammatory drug (NSAID) on the aqueous profiles.
SETTING


Singapore National Eye Center, Singapore.
DESIGN


Randomized controlled trial.
METHODS


Thirty-five patients were randomized to receive conventional phacoemulsification in one eye and femtosecond laser-assisted cataract surgery in the fellow eye. Another matched prospective cohort of 35 patients was included to receive femtosecond laser-assisted cataract surgery with a preoperative NSAID. Aqueous humor was collected after the laser was used or at the beginning of surgery (conventional phacoemulsification), and at the end of phacoemulsification. The levels of aqueous malondialdehyde (MDA), PGE 2 , and cytokines, chemokines, and growth factors were analyzed. The postoperative aqueous flare levels were evaluated.
RESULTS


Compared with the conventional group, the femtosecond-assisted group had a significantly higher PGE 2  (P = .01) and interleukin-1 receptor antagonist levels (P = 0.04). The preoperative NSAID significantly reduced the PGE 2  surge (P = .002) and the mean reduction in pupil diameter (P = .02). The MDA concentrations before phacoemulsification were 0.24 μmol/L ± 0.18 (SD), 0.51 ± 0.41 μmol/L and 0.59 ± 0.52 μmol/L for the conventional, femtosecond-assisted, and femtosecond-assisted NSAID groups, respectively (P = .42). After phacoemulsification, the PGE 2  and MDA levels increased in all groups. The MDA induction was significantly correlated with the phacoemulsification time (P = .002). The postoperative flare was insignificantly higher in the femtosecond-assisted group than the conventional group.
CONCLUSIONS


Compared with conventional phacoemulsification, the femtosecond laser-assisted cataract surgery performed with the Femto LDV Z8 laser platform induced a significantly higher PGE 2  level. The MDA and postoperative aqueous flare level were insignificantly higher. The preoperative NSAID reduced the PGE 2  surge and occurrence of intraoperative miosis. The oxidative stress induced during phacoemulsification was strongly correlated with phacoemulsification time.",2019,The preoperative NSAID significantly reduced the PGE 2  surge (P = .002) and the mean reduction in pupil diameter (P = .02).,"['Thirty-five patients', '35 patients', 'Singapore National Eye Center, Singapore']","['femtosecond laser-assisted cataract surgery with a preoperative NSAID', 'conventional phacoemulsification', 'nonsteroidal antiinflammatory drug (NSAID', 'conventional phacoemulsification in one eye and femtosecond laser-assisted cataract surgery in the fellow eye', 'femtosecond laser-assisted cataract surgery performed with the Femto LDV Z8 laser platform', 'low-energy femtosecond laser-assisted cataract surgery versus conventional phacoemulsification']","['oxidative stress', 'levels of aqueous malondialdehyde (MDA), PGE 2 , and cytokines, chemokines, and growth factors', 'postoperative aqueous flare levels', 'MDA and postoperative aqueous flare level', 'MDA levels', 'aqueous oxidative stress, prostaglandin E 2  (PGE 2 ), and cytokine levels', 'MDA induction', 'postoperative flare', 'interleukin-1 receptor antagonist levels', 'mean\xa0reduction in pupil diameter', 'MDA concentrations', 'phacoemulsification time']","[{'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0763149', 'cui_str': 'PG(6)E'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0524490', 'cui_str': 'Aqueous Flare'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0033559', 'cui_str': 'PGE'}, {'cui': 'C2317059', 'cui_str': 'Interleukin 1 receptor antagonist product'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",35.0,0.0276067,The preoperative NSAID significantly reduced the PGE 2  surge (P = .002) and the mean reduction in pupil diameter (P = .02).,"[{'ForeName': 'Yu-Chi', 'Initials': 'YC', 'LastName': 'Liu', 'Affiliation': 'Cornea and Refractive Surgery Group, Eye Research Institute, Singapore; Singapore National Eye Centre, Singapore; Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Setiawan', 'Affiliation': 'Cornea and Refractive Surgery Group, Eye Research Institute, Singapore.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Ang', 'Affiliation': 'Cornea and Refractive Surgery Group, Eye Research Institute, Singapore; Singapore National Eye Centre, Singapore.'}, {'ForeName': 'Gary Hin Fai', 'Initials': 'GHF', 'LastName': 'Yam', 'Affiliation': 'Cornea and Refractive Surgery Group, Eye Research Institute, Singapore; Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Jodhbir S', 'Initials': 'JS', 'LastName': 'Mehta', 'Affiliation': 'Cornea and Refractive Surgery Group, Eye Research Institute, Singapore; Singapore National Eye Centre, Singapore; Duke-NUS Medical School, Singapore. Electronic address: jodmehta@gmail.com.'}]",Journal of cataract and refractive surgery,['10.1016/j.jcrs.2018.09.022']
731,30574797,HTX-019 via 2-min injection or 30-min infusion in healthy subjects.,"AIM


HTX-019 (CINVANTI ®  [aprepitant injectable emulsion]) is a neurokinin 1 receptor antagonist approved for preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV). HTX-019 is free of polysorbate 80 and other synthetic surfactants and showed bioequivalence to and a more favorable safety profile than fosaprepitant when administered as a 30-min infusion in healthy subjects. The shortage of small-volume parenteral solutions led to a recommendation to administer HTX-019 by intravenous push. The objectives were to evaluate pharmacokinetics, tolerability and safety following HTX-019 administration by injection versus infusion.
MATERIALS & METHODS


Study comprised Part A, a pilot Phase I, single-center, randomized, pharmacokinetic, safety and tolerability, open-label study, followed by Part B, a two-sequence crossover study of HTX-019 130 mg in healthy adults, via injection and infusion. Blood samples were evaluated for aprepitant pharmacokinetics and bioequivalence. Safety evaluations included treatment-emergent adverse events (TEAEs), vital signs, clinical laboratory testing and electrocardiograms.
RESULTS


In Part A, 24 subjects were randomly assigned to three cohorts (n = 8 per cohort) and received HTX-019 130 mg, administered intravenously over 15 min (cohort 1), 5 min (cohort 2) or 2 min (cohort 3). Progression to Part B occurred after acceptable tolerability was established in cohorts 2 and 3. In Part B, 50 randomized subjects received a 2-min injection (9 ml/min) and 30-min infusion (296 ml/h) of HTX-019 130 mg. Bioequivalence was demonstrated for HTX-019 injection and infusion. Both administration methods via a peripheral line were well tolerated; eight subjects experienced 11 TEAEs (six related) following injection and nine experienced 14 TEAEs (nine related) following infusion. Headache and fatigue were the most prevalent treatment-related TEAEs; one subject per group experienced feeling hot ≤30 min after drug administration.
CONCLUSION


Pharmacokinetic and tolerability profiles of 2-min HTX-019 injection support this potential alternative administration method for CINV prevention.",2019,"Headache and fatigue were the most prevalent treatment-related TEAEs; one subject per group experienced feeling hot ≤30 min after drug administration.
","['24 subjects', 'healthy adults, via injection and infusion', 'healthy subjects']","['HTX-019 130\xa0mg', 'HTX-019 (CINVANTI ®  [aprepitant injectable emulsion', 'HTX-019 via 2-min injection or 30-min infusion', 'HTX-019']","['pharmacokinetics, tolerability and safety', 'Headache and fatigue', 'treatment-emergent adverse events (TEAEs), vital signs, clinical laboratory testing and electrocardiograms']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C4541790', 'cui_str': 'Cinvanti'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518766'}, {'cui': 'C4505475', 'cui_str': 'Clinical Laboratory Testings'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]",24.0,0.0736851,"Headache and fatigue were the most prevalent treatment-related TEAEs; one subject per group experienced feeling hot ≤30 min after drug administration.
","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ottoboni', 'Affiliation': 'Heron Therapeutics, Inc., 4242 Campus Point Court, Suite 200, San Diego, CA 92121, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lauw', 'Affiliation': 'Heron Therapeutics, Inc., 4242 Campus Point Court, Suite 200, San Diego, CA 92121, USA.'}, {'ForeName': 'Mary Rose', 'Initials': 'MR', 'LastName': 'Keller', 'Affiliation': 'Heron Therapeutics, Inc., 4242 Campus Point Court, Suite 200, San Diego, CA 92121, USA.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Cravets', 'Affiliation': 'Heron Therapeutics, Inc., 4242 Campus Point Court, Suite 200, San Diego, CA 92121, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Manhard', 'Affiliation': 'Heron Therapeutics, Inc., 4242 Campus Point Court, Suite 200, San Diego, CA 92121, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Clendeninn', 'Affiliation': 'Heron Therapeutics, Inc., 4242 Campus Point Court, Suite 200, San Diego, CA 92121, USA.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Quart', 'Affiliation': 'Heron Therapeutics, Inc., 4242 Campus Point Court, Suite 200, San Diego, CA 92121, USA.'}]","Future oncology (London, England)",['10.2217/fon-2018-0809']
732,30470646,Low-dose Desmopressin Orally Disintegrating Tablet: Suggested Clinically Meaningful Benefit in Patients with Nocturia Due to Nocturnal Polyuria.,"BACKGROUND


Clinical benefit has not been evaluated much in patients with nocturia.
OBJECTIVE


To assess the clinical benefit of desmopressin orally disintegrating tablet (ODT) in women (25μg) and men (50μg) with nocturia due to nocturnal polyuria (NP).
DESIGN, SETTING, AND PATIENTS


Patients with NP from two randomised, placebo-controlled trials in men (CS41) and women (CS40) with two or more nocturnal voids per night were included.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Change from baseline in nocturnal voids, 33% and 50% responder status (average reduction of ≤33% and ≤50%, respectively, in the mean number of nocturnal voids vs baseline), and percentage of nights with at most one void or no voids (ie, complete response) during 3-mo treatment period were assessed for clinical benefit. Two-sided test (5% significance level) was used for all endpoints.
RESULTS AND LIMITATIONS


Demographics and baseline characteristics of patients in CS41 (N=230) and CS40 (N=232) were similar. A greater reduction in the mean number of nocturnal voids was seen with desmopressin ODT in men (treatment difference [TD]: -0.37 voids) compared with women (TD: -0.29 voids). For 33% and 50% responder status, TD with ODT versus placebo were 21% and 12%, respectively, in men, and 12% and 17%, respectively, in women. For the number of nights with at most one void, TDs were 11% and 13% (p<0.009 for both) for men and women, respectively. For complete response, TD was significant in men (TD: 9%, p<0.001). Limitations inherent in this analysis were evident as the data for cotreatments (baseline) and quality of life were not collected.
CONCLUSIONS


A stronger treatment effect with desmopressin ODT versus placebo and the magnitude of differences are indicative of clinical benefit in patients with NP.
PATIENT SUMMARY


We looked at the clinical benefit of desmopressin ODT in patients with nocturnal polyuria. We conclude that clinical benefit was observed with desmopressin ODT in these patients.",2020,A greater reduction in the mean number of nocturnal voids was seen with desmopressin ODT in men (treatment difference [TD]: -0.37 voids) compared with women (TD: -0.29 voids).,"['Patients with NP from two randomised, placebo-controlled trials in men (CS41) and women (CS40) with two or more nocturnal voids per night were included', 'Patients with Nocturia Due to Nocturnal Polyuria', 'patients with NP', 'patients with nocturia', 'patients with nocturnal polyuria', 'women (25μg) and men (50μg) with nocturia due to nocturnal polyuria (NP']","['placebo', 'Desmopressin Orally Disintegrating Tablet', 'desmopressin orally disintegrating tablet (ODT', 'desmopressin ODT', 'desmopressin ODT versus placebo']","['mean number of nocturnal voids', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0848232', 'cui_str': 'Nocturnal polyuria'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011701', 'cui_str': 'desmopressin'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0034380'}]",232.0,0.0983808,A greater reduction in the mean number of nocturnal voids was seen with desmopressin ODT in men (treatment difference [TD]: -0.37 voids) compared with women (TD: -0.29 voids).,"[{'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Weiss', 'Affiliation': 'Department of Urology, SUNY Downstate Medical School, Brooklyn, New York, USA.'}, {'ForeName': 'Egbert A', 'Initials': 'EA', 'LastName': 'van der Meulen', 'Affiliation': 'Ferring Pharmaceuticals, Copenhagen S, Denmark.'}, {'ForeName': 'Kristian Vinter', 'Initials': 'KV', 'LastName': 'Juul', 'Affiliation': 'Ferring Pharmaceuticals, Copenhagen S, Denmark. Electronic address: Kristian.Juul@ferring.com.'}]",European urology focus,['10.1016/j.euf.2018.11.001']
733,31617568,Immunogenicity of 2 and 3 Doses of the Quadrivalent Human Papillomavirus Vaccine up to 120 Months Postvaccination: Follow-up of a Randomized Clinical Trial.,"BACKGROUND


Several countries have implemented a 2-dose (2D) human papillomavirus (HPV) vaccination schedule for adolescents based on immunobridging studies. We compared immunogenicity of 2D vs 3-dose (3D) schedules of the quadrivalent vaccine (4vHPV) up to 10 years after the first dose.
METHODS


Girls aged 9-13 years were randomized to receive 2D or 3D and were compared with women aged 16-26 receiving 3D at day 1 and months 7, 24, and 120 after the first dose. Antibody levels for HPV6/11/16/18 were evaluated using the competitive Luminex immunoassay (cLIA) and total immunoglobulin G assay. Geometric mean titers (GMTs) and seropositivity rates were compared between the different groups at different time points. Noninferiority of GMT ratios was defined as the lower bound of the 2-sided 95% confidence interval (CI) being greater than 0.5. Kinetics of antibody titers over time among study groups were examined.
RESULTS


At 120 months, data from 35 2D girls, 38 3D girls, and 30 3D women were used for analyses. cLIA seropositivity rates were above 95% for all HPV vaccine types and all schedules, except HPV18, with the lowest seropositivity observed among 3D women (60.0%; 95% CI, 40.6%-77.3%). GMT ratios (cLIA) for both 2D and 3D girls were noninferior to 3 doses in women for HPV6/11/16/18. Trends were comparable between assays.
CONCLUSIONS


GMTs for HPV6/11/16/18 after 2D or 3D of 4vHPV in girls were noninferior to 3D in adult women up to 120 months postvaccination. This study demonstrates long-term immunogenicity of the 2D HPV vaccine schedule.",2020,"cLIA seropositivity rates were above 95% for all HPV vaccine types and all schedules, except HPV18, with the lowest seropositivity observed among 3D women (60.0%; 95% CI, 40.6%-77.3%).","['35 2D girls, 38 3D girls, and 30 3D women', 'Girls aged 9-13 years']","['Quadrivalent Human Papillomavirus Vaccine', 'quadrivalent vaccine (4vHPV']","['GMT ratios (cLIA', 'Antibody levels', 'Kinetics of antibody titers', 'cLIA seropositivity rates', 'GMT ratios', 'Immunogenicity', 'Geometric mean titers (GMTs) and seropositivity rates']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",,0.15292,"cLIA seropositivity rates were above 95% for all HPV vaccine types and all schedules, except HPV18, with the lowest seropositivity observed among 3D women (60.0%; 95% CI, 40.6%-77.3%).","[{'ForeName': 'Robine', 'Initials': 'R', 'LastName': 'Donken', 'Affiliation': ""Vaccine Evaluation Center, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Simon R M', 'Initials': 'SRM', 'LastName': 'Dobson', 'Affiliation': ""Vaccine Evaluation Center, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Kim D', 'Initials': 'KD', 'LastName': 'Marty', 'Affiliation': ""Vaccine Evaluation Center, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Darrel', 'Initials': 'D', 'LastName': 'Cook', 'Affiliation': 'Public Health Laboratory, BC Centre for Disease Control, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Sauvageau', 'Affiliation': 'Institut National de Sante Publique du Quebec, Quebec, Canada.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Gilca', 'Affiliation': 'Institut National de Sante Publique du Quebec, Quebec, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Dionne', 'Affiliation': 'Department of Social and Preventive Medicine, Laval University, Quebec, Canada.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'McNeil', 'Affiliation': 'Canadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health Authority, Dalhousie University, Nova Scotia, Canada.'}, {'ForeName': 'Mel', 'Initials': 'M', 'LastName': 'Krajden', 'Affiliation': 'Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Money', 'Affiliation': ""Women's Health Research Institute, BC Women's Hospital and Health Service, Vancouver, British Columbia, Canada.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kellner', 'Affiliation': ""Alberta Children's Hospital Infectious Diseases Epidemiology & Vaccine Evaluation Team, Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Scheifele', 'Affiliation': ""Vaccine Evaluation Center, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kollmann', 'Affiliation': ""Vaccine Evaluation Center, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Bettinger', 'Affiliation': ""Vaccine Evaluation Center, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Vaccine Evaluation Center, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': 'Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Naus', 'Affiliation': 'Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Sadarangani', 'Affiliation': ""Vaccine Evaluation Center, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Gina S', 'Initials': 'GS', 'LastName': 'Ogilvie', 'Affiliation': ""Women's Health Research Institute, BC Women's Hospital and Health Service, Vancouver, British Columbia, Canada.""}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz887']
734,30198809,Feasibility of an intensive outpatient Perception-Action Approach intervention for children with cerebral palsy: a pilot study.,"PURPOSE


The purpose of this pilot study was (1) to evaluate feasibility of attendance and parent satisfaction with an intensive outpatient physical and occupational therapy program for young children with spastic cerebral palsy (CP) and (2) to examine changes in motor function.  Methods : Sixteen children with CP, age range 18-36 months (mean 24.3 ± 6.3 months), received physical and occupational therapy sessions (30 minutes each) 5 days per week for 12 weeks. Attendance rates and parent satisfaction were assessed. Change in motor function using a one-group pre-post design was evaluated using the Gross Motor Function Measure-66 (GMFM-66), Quality of Upper Extremity Skills Test, and Pediatric Evaluation of Disability Inventory. GMFM-66 outcomes were also compared with expected outcomes using previously published normative developmental trajectories of children receiving standard therapies.  Results : An average of 82% of scheduled outpatient physical and occupational therapies for 16 children were completed and the 11 parents who completed the Hills and Kitchen's Physiotherapy Outpatient Satisfaction Questionnaire were satisfied with the therapies and with their child's progress. Participants showed notable, statistically significant improvement across all activity-related measures.  Conclusion : An intensive protocol of outpatient therapies utilizing Perception-Action Approach was feasible for most families of young children with spastic CP to attend at the outpatient clinic location. As this was not an experimental study, no reliable conclusions related to efficacy can be made, but the promising results suggest that further research into the effectiveness of intensive protocols is worthwhile.",2020,An intensive protocol of outpatient therapies utilizing Perception-Action Approach was feasible for most families of young children with spastic CP to attend at the outpatient clinic location.,"['young children with spastic CP to attend at the outpatient clinic location', 'children with cerebral palsy', 'Sixteen children with CP, age range 18-36\xa0months (mean 24.3\xa0±\xa06.3\xa0months), received', ""16 children were completed and the 11 parents who completed the Hills and Kitchen's Physiotherapy Outpatient Satisfaction Questionnaire were satisfied with the therapies and with their child's progress"", 'young children with spastic cerebral palsy (CP) and (2']","['intensive outpatient physical and occupational therapy program', 'intensive outpatient Perception-Action Approach intervention', 'physical and occupational therapy sessions (30\xa0minutes each']","['Change in motor function', 'Attendance rates and parent satisfaction', 'activity-related measures', 'Gross Motor Function Measure-66 (GMFM-66), Quality of Upper Extremity Skills Test, and Pediatric Evaluation of Disability Inventory']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0443306', 'cui_str': 'Spastic'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0442532', 'cui_str': 'Hill (environment)'}, {'cui': 'C0557653', 'cui_str': 'Kitchen (environment)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy (disorder)'}]","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",16.0,0.0172062,An intensive protocol of outpatient therapies utilizing Perception-Action Approach was feasible for most families of young children with spastic CP to attend at the outpatient clinic location.,"[{'ForeName': 'Heidi L', 'Initials': 'HL', 'LastName': 'Pottinger', 'Affiliation': 'Department of Health Promotion Sciences, Mel and Enid Zuckerman College of Public Health, University of Arizona , Tucson, AZ, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Rahlin', 'Affiliation': 'Department of Physical Therapy, College of Health Professions, Rosalind Franklin University of Medicine and Science , North Chicago, IL, USA.'}, {'ForeName': 'Jessiemarie', 'Initials': 'J', 'LastName': 'Voigt', 'Affiliation': 'Department of Health Promotion Sciences, Mel and Enid Zuckerman College of Public Health, University of Arizona , Tucson, AZ, USA.'}, {'ForeName': 'Michele E', 'Initials': 'ME', 'LastName': 'Walsh', 'Affiliation': 'Department of Family Studies and Human Development, Norton School of Family and Consumer Sciences, University of Arizona , Tucson, AZ, USA.'}, {'ForeName': 'Charlene M', 'Initials': 'CM', 'LastName': 'Fregosi', 'Affiliation': 'Tucson Medical Center, Outpatient Therapies and Audiology , Tucson, AZ, USA.'}, {'ForeName': 'Burris R', 'Initials': 'BR', 'LastName': 'Duncan', 'Affiliation': 'Department of Health Promotion Sciences, Mel and Enid Zuckerman College of Public Health, University of Arizona , Tucson, AZ, USA.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1517847']
735,30188176,"Comparison of a 12-Week Whole-Body Exergaming Program on Young Adults: Differentiation in Flexibility, Muscle Strength, Reaction Time, and Walking Speed Between Sexes.","This study aimed to investigate the effects of exergaming on flexibility, muscle strength, reaction time, and walking speed of adults within sex differences. Fifty-four individuals participated in a 12-week exergaming program. Three 30-min sessions were conducted each week. Baseline and post-intervention assessments were done using the sit-and-reach and bend-over tests for flexibility, hand-held dynamometer for muscle strength, auditory and visual reaction time machine for reaction time, and 5-meter walk test for walking speed. There were no significant changes in the sit-and-reach, bend-over test, and auditory-visual reaction time for either gender ( p  > .05) with the intervention. Walking speed and muscle strength improved after exergaming in both sexes ( p  < .05). The study showed that the video gaming intervention led to significant and equal improvements in muscle strength and walking speed for both sexes; however, it had no impact on flexibility and auditory-visual reaction time.",2020,"There were no significant changes in the sit-and-reach, bend-over test, and auditory-visual reaction time for either gender ( p > .05) with the intervention.","['Young Adults', 'Fifty-four individuals participated in a 12-week exergaming program']","['video gaming intervention', '12-Week Whole-Body Exergaming Program']","['Walking speed and muscle strength', 'sit-and-reach, bend-over test, and auditory-visual reaction time', 'flexibility, muscle strength, reaction time, and walking speed of adults within sex differences', 'Flexibility, Muscle Strength, Reaction Time, and Walking Speed Between Sexes', 'flexibility and auditory-visual reaction time', 'sit-and-reach and bend-over tests for flexibility, hand-held dynamometer for muscle strength, auditory and visual reaction time machine for reaction time, and 5-meter walk test for walking speed', 'muscle strength and walking speed']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0205133', 'cui_str': 'Bent (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036866', 'cui_str': 'Sexual Dimorphism'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1553387', 'cui_str': 'Hold'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",54.0,0.0125525,"There were no significant changes in the sit-and-reach, bend-over test, and auditory-visual reaction time for either gender ( p > .05) with the intervention.","[{'ForeName': 'Yeşim', 'Initials': 'Y', 'LastName': 'Bakar', 'Affiliation': 'Izmir Bakircay University, Turkey.'}, {'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Tuğral', 'Affiliation': 'Bolu Abant Izzet Baysal University, Turkey.'}, {'ForeName': 'Alp', 'Initials': 'A', 'LastName': 'Özel', 'Affiliation': 'Bolu Abant Izzet Baysal University, Turkey.'}, {'ForeName': 'Yasin D', 'Initials': 'YD', 'LastName': 'Altuntaş', 'Affiliation': 'Bolu Abant Izzet Baysal University, Turkey.'}]",Clinical nursing research,['10.1177/1054773818797881']
736,31650328,Successful elevation of circulating acetate and propionate by dietary modulation does not alter T-regulatory cell or cytokine profiles in healthy humans: a pilot study.,"PURPOSE


Increased circulating concentrations of short-chain fatty acids (SCFA) achieved by ingestion of high-fibre diets is associated with anti-inflammatory effects through promotion of FoxP3+ regulatory T(reg) cells in mouse models. This study aimed to determine whether similar increments in blood SCFA levels can be achieved in humans and whether these are associated with similar immune modulatory effects.
METHODS


In a pilot single-blinded, randomised, controlled cross-over study in ten healthy subjects, the effects were determined of high- (39 g/day) and low-fibre (18 g/day) intake (all food provided) on SCFA (gas chromatography), proportions of Treg cells (flow cytometry) and a panel of cytokines (multiplex methodology) measured in peripheral blood at day 5 of each diet.
RESULTS


Actual fibre intake differed between the diets by 19 [16-21] g/day (P< 0.001). Median [range] total plasma SCFA levels with high-fibre intake were 174.5 [104.8-249.5] µmol/L, which were greater than those associated with low-fibre intake at 59.0 [26.5-79.9] (P < 0.001). Differences were significantly different for both acetate and propionate. The frequencies of total CD4 T cells and T-regulatory cells, and concentrations of inflammatory and anti-inflammatory cytokines were not significantly different between the dietary interventions.
CONCLUSIONS


Plasma SCFA levels can be modulated by altering dietary fibre consumption in healthy individuals with increments similar to those achieved in murine studies. Five days of diet intervention did not result in changes in regulatory T-cell proportions and cytokine concentrations in peripheral blood, and may require longer duration of dietary change.",2020,"Five days of diet intervention did not result in changes in regulatory T-cell proportions and cytokine concentrations in peripheral blood, and may require longer duration of dietary change.","['healthy individuals', 'ten healthy subjects', 'healthy humans']",['short-chain fatty acids (SCFA'],"['regulatory T-cell proportions and cytokine concentrations', 'frequencies of total CD4 T cells and T-regulatory cells, and concentrations of inflammatory and anti-inflammatory cytokines', 'blood SCFA levels', 'SCFA (gas chromatography), proportions of Treg cells (flow cytometry', 'Median [range] total plasma SCFA levels', 'Actual fibre intake']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0015691', 'cui_str': 'Fatty Acids, Short-Chain'}]","[{'cui': 'C0039198', 'cui_str': 'T-Cells, Regulatory'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C1267822', 'cui_str': 'T lymphocyte positive for both CD4 antigen and CD25 antigen'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0008555', 'cui_str': 'Gas Chromatography'}, {'cui': 'C0016263', 'cui_str': 'Flow Microfluorimetry'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}]",10.0,0.128307,"Five days of diet intervention did not result in changes in regulatory T-cell proportions and cytokine concentrations in peripheral blood, and may require longer duration of dietary change.","[{'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Gill', 'Affiliation': 'Department of Gastroenterology, Central Clinical School, Monash University and Alfred Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Menno C', 'Initials': 'MC', 'LastName': 'van Zelm', 'Affiliation': 'Department of Immunology and Pathology, Central Clinical School, Monash University and Alfred Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Rosemary A', 'Initials': 'RA', 'LastName': 'Ffrench', 'Affiliation': 'Burnet Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'Jane G', 'Initials': 'JG', 'LastName': 'Muir', 'Affiliation': 'Department of Gastroenterology, Central Clinical School, Monash University and Alfred Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Gibson', 'Affiliation': 'Department of Gastroenterology, Central Clinical School, Monash University and Alfred Hospital, Melbourne, VIC, Australia. Peter.gibson@monash.edu.'}]",European journal of nutrition,['10.1007/s00394-019-02113-2']
737,31647185,"IncobotulinumtoxinA Treatment in Upper-Limb Poststroke Spasticity in the Open-Label Extension Period of PURE: Efficacy in Passive Function, Caregiver Burden, and Quality of Life.","BACKGROUND


Poststroke spasticity affects motor function and the ability to perform activities of daily living, with the potential to affect quality of life (QoL) and increase caregiver burden.
OBJECTIVE


To investigate the effect of repeated incobotulinumtoxinA treatment on spasticity-associated functional disability, caregiver burden, and QoL in the 36-week open-label extension of the phase 3 PURE study (NCT01392300).
DESIGN


Open-label extension period of a prospective, double-blind, placebo-controlled, randomized, multicenter study.
SETTING


Forty-six investigation sites in seven countries (Czech Republic, Germany, Hungary, India, Poland, Russia, United States).
PARTICIPANTS


Adults, aged 18-80 years, ≥12 months since last botulinum neurotoxin injection or entirely toxin naïve, with median poststroke upper-limb spasticity of >2 years' duration.
METHODS


Participants who completed the 12-week, double-blind main period could enter the open-label extension and receive up to three additional incobotulinumtoxinA treatments (fixed total dose 400 U at 12-week intervals) into the affected muscles of one upper limb.
MAIN OUTCOME MEASURES


Functional disability (Disability Assessment Scale; DAS), caregiver burden (Carer Burden Scale), and quality of life (QoL; EuroQol [EQ] 5-dimensions three-level [EQ-5D-3L]).
RESULTS


The open-label extension included 296 treated patients. Mean DAS score for the principal target domain improved significantly from the main period baseline to the end-of-study visit (P < .0001). Carer Burden Scale scores also significantly improved from the main period baseline to the end-of-study visit (P < .05 for all caregiving activities except ""applying a splint""). At the end-of-study visit, versus the main period baseline, 19.7%-33.3% of patients experienced improvements for each parameter on the EQ-5D-3L, except ""mobility,"" with significant improvement in EQ-5D visual analog scale scores (P < .001).
CONCLUSIONS


Repeated incobotulinumtoxinA treatments at 12-week intervals in participants with chronic poststroke upper-limb spasticity resulted in significant improvements in QoL, as well as significant reductions in upper-limb functional disability and caregiver burden.",2020,Mean DAS score for the principal target domain improved significantly from the main period baseline to the end-of-study visit (P<.0001).,"['Forty-six investigation sites in seven countries (Czech Republic, Germany, Hungary, India, Poland, Russia, USA', '296 treated subjects', 'Subjects who completed the 12-week, double-blind main period could enter the', ""Adults, aged 18-80\u2009years, ≥12 months since last botulinum neurotoxin injection or entirely toxin-naïve, with median post-stroke upper-limb spasticity of >2\u2009years' duration""]","['IncobotulinumtoxinA', 'placebo', 'incobotulinumtoxinA', 'open-label extension and receive up to three additional incobotulinumtoxinA treatments (fixed total dose 400 U at 12-week intervals) into the affected muscles of one upper limb']","['EQ-5D visual analog scale scores', 'spasticity-associated functional disability, caregiver burden, and QoL', 'Functional disability (Disability Assessment Scale; DAS), caregiver burden (Carer Burden Scale), and quality of life (QoL; EuroQol 5-dimensions three-level [EQ-5D-3L', 'Mean DAS score', 'upper-limb functional disability and caregiver burden', 'Carer Burden Scale scores', ""EQ-5D-3L, except 'mobility"", 'Passive Function, Caregiver Burden and Quality of Life', 'QoL']","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0206578', 'cui_str': 'Czech Republic'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0020174', 'cui_str': 'Hungary'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0035970', 'cui_str': 'Russian Federation (Europe)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1295507', 'cui_str': 'Botulinum neurotoxin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C4522020', 'cui_str': 'Toxin'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1273957', 'cui_str': 'Upper limb spasticity'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C2930113', 'cui_str': 'incobotulinumtoxinA'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}, {'cui': 'C0051767', 'cui_str': 'DASD'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0222045'}, {'cui': 'C0034380'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",46.0,0.155475,Mean DAS score for the principal target domain improved significantly from the main period baseline to the end-of-study visit (P<.0001).,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Marciniak', 'Affiliation': 'Department of Physical Medicine and Rehabilitation and Department of Neurology, Northwestern University Feinberg School of Medicine and Shirley Ryan Ability Lab, Chicago, IL.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Munin', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Brashear', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Wake Forest Baptist Medical Center, Winston-Salem, NC.'}, {'ForeName': 'Bruce S', 'Initials': 'BS', 'LastName': 'Rubin', 'Affiliation': 'Design Neuroscience Center, Doral, FL.'}, {'ForeName': 'Atul T', 'Initials': 'AT', 'LastName': 'Patel', 'Affiliation': 'Kansas City Bone & Joint Clinic, Overland Park, KS.'}, {'ForeName': 'Jaroslaw', 'Initials': 'J', 'LastName': 'Slawek', 'Affiliation': 'Department of Neurological-Psychiatric Nursing, Medical University of Gdansk, Gdansk, Poland.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Hanschmann', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Hiersemenzel', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Elie P', 'Initials': 'EP', 'LastName': 'Elovic', 'Affiliation': 'Department of Medicine, University of Nevada at Reno, Reno, NV.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12265']
738,31645164,"Combined with ticagrelor, 50 mg aspirin daily can reduce bleeding events without increasing ischemic risk compared with 75-100 mg aspirin daily in coronary artery disease patients: insights from the TIFU (Ticagrelor in Fuwai Hospital) study.","Patients treated with ticagrelor and aspirin usually suffer from bleeding events, especially mild bleeding which is one of the main factors reducing patients' adherence to ticagrelor. The objective of this study is to investigate the efficacy and safety of ticagrelor combined with a lower dose of aspirin (50 mg) than that recommended by guidelines (75-100 mg). In this study, we prospectively enrolled 1220 patients who take ticagrelor in the hospital. After excluding the patients who did not take ticagrelor after discharge or lost to follow-up, the remaining 1066 patients were divided into two aspirin dose groups: 75-100 mg ( n  = 744) and 50 mg ( n  = 322). The rates of major adverse cardiovascular events (MACEs), bleeding events and ticagrelor adherence were compared between the two groups. MACEs risk was not significantly different between the two groups (OR = 0.563, 95% CI: 0.244-1.300,  P  = .179). However, 50 mg aspirin was associated with a lower risk of any Bleeding Academic Research Consortium (BARC) bleeding events (OR = 0.605, 95% CI: 0.399-0.713,  P  = .001), also lower BARC bleeding events (OR = 0.639, 95% CI: 0.468-0.872,  P  = .005). Moreover, lower-dose aspirin was associated with a lower rate of ticagrelor withdrawal (OR = 0.459, 95% CI: 0.279-0.754,  P  = .002), mainly because of the decrease in ticagrelor withdrawal due to bleeding (OR = 0.378, 95% CI: 0.156-0.916,  P  = .031). After propensity score matching (PSM), a total of 317 patients in each group were matched. The MACEs composite was not significantly different between the two matched groups and 50 mg aspirin was associated with a lower risk of bleeding events and low ticagrelor withdrawal before and after multivariate adjustment. In conclusion, among patients who took ticagrelor (90 mg twice daily), 50 mg aspirin daily is associated with a lower rate of bleeding events and ticagrelor withdrawal but does not increase the MACE risk compared with 75-100 mg aspirin daily.",2020,The MACEs composite was not significantly different between the two matched groups and 50 mg aspirin was associated with a lower risk of bleeding events and low ticagrelor withdrawal before and after multivariate adjustment.,"['1220 patients who take ticagrelor in the hospital', 'coronary artery disease patients', 'after discharge or lost to follow-up, the remaining 1066 patients']","['ticagrelor and aspirin', 'ticagrelor', 'aspirin', 'TIFU (Ticagrelor']","['bleeding events', 'ticagrelor withdrawal due to bleeding', 'rates of major adverse cardiovascular events (MACEs), bleeding events and ticagrelor adherence', 'efficacy and safety', 'lower BARC bleeding events', 'rate of bleeding events', 'rate of ticagrelor withdrawal', 'lower risk of bleeding events', 'MACEs risk', 'lower risk of any Bleeding Academic Research Consortium (BARC) bleeding events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035168'}]",1220.0,0.0414725,The MACEs composite was not significantly different between the two matched groups and 50 mg aspirin was associated with a lower risk of bleeding events and low ticagrelor withdrawal before and after multivariate adjustment.,"[{'ForeName': 'Jiannan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Peking Union Medical College & Chinese Academy of Medical Sciences , Beijing, China.'}, {'ForeName': 'Zhaoxue', 'Initials': 'Z', 'LastName': 'Sheng', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Peking Union Medical College & Chinese Academy of Medical Sciences , Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Peking Union Medical College & Chinese Academy of Medical Sciences , Beijing, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Peking Union Medical College & Chinese Academy of Medical Sciences , Beijing, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Peking Union Medical College & Chinese Academy of Medical Sciences , Beijing, China.'}, {'ForeName': 'Jinying', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Peking Union Medical College & Chinese Academy of Medical Sciences , Beijing, China.'}, {'ForeName': 'Runzhen', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Peking Union Medical College & Chinese Academy of Medical Sciences , Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Peking Union Medical College & Chinese Academy of Medical Sciences , Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Peking Union Medical College & Chinese Academy of Medical Sciences , Beijing, China.'}, {'ForeName': 'Hanjun', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Peking Union Medical College & Chinese Academy of Medical Sciences , Beijing, China.'}, {'ForeName': 'Hongbing', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Peking Union Medical College & Chinese Academy of Medical Sciences , Beijing, China.'}]",Platelets,['10.1080/09537104.2019.1680825']
739,29859274,The post-trial analysis of the Indian SMS diabetes prevention study shows persistent beneficial effects of lifestyle intervention.,"AIMS


We had shown that mobile phone based text messaging was an effective tool to deliver lifestyle changes among Asian Indian men with a 36% relative risk reduction in incident diabetes over two years. The present analysis investigated whether beneficial effects of intervention on diabetes prevention persisted for an additional three years after withdrawal of active intervention.
METHODS


The primary two year randomized controlled trial (2010-2012) compared lifestyle changes with use of automated text messaging reminders in the intervention (n = 271) versus standard care advice (n = 266) at baseline. At the end of the study, both groups received additional advice on lifestyle changes by a trained dietician. Participants free of diabetes (n = 394) were invited three years later to ascertain the sustained effect of intervention. The primary outcome was incidence of type 2 diabetes. This trial is registered with ClinicalTrials.gov,number NCT02848547.
RESULTS


During the mean follow-up of 5 years, 346 out of 394 (87.8%) men were reviewed. Incidence of diabetes was reduced by 30% in the intervention group, with declining gap between-group differences over time (Kaplan-Meier analysis). Significant improvement in dietary adherence occurred in the intervention group at 2nd and 5th year follow up (trend χ 2  = 21.35, p < 0.0001). Cox regression analysis showed that the 5th year incidence of diabetes was significantly reduced in the intervention group. Higher body mass index and 2 h plasma glucose at 24 months increased the incidence of diabetes.
CONCLUSIONS


Sustained reduction in incident diabetes was apparent after cessation of active lifestyle intervention. This was possibly associated with continuing practice of improved lifestyle.",2018,"Significant improvement in dietary adherence occurred in the intervention group at 2nd and 5th year follow up (trend χ 2  = 21.35, p < 0.0001).","['During the mean follow-up of 5\u202fyears, 346 out of 394 (87.8%) men were reviewed', 'Participants free of diabetes (n\u202f=\u202f394', 'Asian Indian men with a 36% relative risk reduction in incident diabetes over two years']","['mobile phone based text messaging', 'lifestyle changes with use of automated text messaging reminders in the intervention (n\u202f=\u202f271) versus standard care advice']","['dietary adherence', 'Incidence of diabetes', 'incidence of diabetes', 'incident diabetes', 'Higher body mass index and 2\u202fh plasma glucose', 'incidence of type 2 diabetes']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]",394.0,0.0687167,"Significant improvement in dietary adherence occurred in the intervention group at 2nd and 5th year follow up (trend χ 2  = 21.35, p < 0.0001).","[{'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Nanditha', 'Affiliation': ""India Diabetes Research Foundation and Dr. A. Ramachandran's Diabetes Hospitals, Chennai, India.""}, {'ForeName': 'Chamukuttan', 'Initials': 'C', 'LastName': 'Snehalatha', 'Affiliation': ""India Diabetes Research Foundation and Dr. A. Ramachandran's Diabetes Hospitals, Chennai, India.""}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Raghavan', 'Affiliation': ""India Diabetes Research Foundation and Dr. A. Ramachandran's Diabetes Hospitals, Chennai, India.""}, {'ForeName': 'Ramachandran', 'Initials': 'R', 'LastName': 'Vinitha', 'Affiliation': ""India Diabetes Research Foundation and Dr. A. Ramachandran's Diabetes Hospitals, Chennai, India.""}, {'ForeName': 'Krishnamoorthy', 'Initials': 'K', 'LastName': 'Satheesh', 'Affiliation': ""India Diabetes Research Foundation and Dr. A. Ramachandran's Diabetes Hospitals, Chennai, India.""}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Susairaj', 'Affiliation': ""India Diabetes Research Foundation and Dr. A. Ramachandran's Diabetes Hospitals, Chennai, India.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Simon', 'Affiliation': ""India Diabetes Research Foundation and Dr. A. Ramachandran's Diabetes Hospitals, Chennai, India.""}, {'ForeName': 'Sundaram', 'Initials': 'S', 'LastName': 'Selvam', 'Affiliation': ""India Diabetes Research Foundation and Dr. A. Ramachandran's Diabetes Hospitals, Chennai, India.""}, {'ForeName': 'Jagannathan', 'Initials': 'J', 'LastName': 'Ram', 'Affiliation': 'Hubert Department of Global Health, Emory Global Diabetes Research Center, Atlanta, USA.'}, {'ForeName': 'Addagarla P', 'Initials': 'AP', 'LastName': 'Naveen Kumar', 'Affiliation': 'Visakha Steel General Hospital, Visakhapatnam, India.'}, {'ForeName': 'Ian F', 'Initials': 'IF', 'LastName': 'Godsland', 'Affiliation': 'Faculty of Medicine, Imperial College, London, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Oliver', 'Affiliation': 'Faculty of Medicine, Imperial College, London, UK.'}, {'ForeName': 'Desmond G', 'Initials': 'DG', 'LastName': 'Johnston', 'Affiliation': 'Faculty of Medicine, Imperial College, London, UK.'}, {'ForeName': 'Ambady', 'Initials': 'A', 'LastName': 'Ramachandran', 'Affiliation': ""India Diabetes Research Foundation and Dr. A. Ramachandran's Diabetes Hospitals, Chennai, India. Electronic address: ramachandran@vsnl.com.""}]",Diabetes research and clinical practice,['10.1016/j.diabres.2018.05.042']
740,31350296,Early mobilization and quality of life after stroke: Findings from AVERT.,"OBJECTIVE


To determine whether early and more frequent mobilization after stroke affects health-related quality of life.
METHODS


A Very Early Rehabilitation Trial (AVERT) was an international, multicenter (56 sites), phase 3 randomized controlled trial, spanning 2006-2015. People were included if they were aged ≥18 years, presented within 24 hours of a first or recurrent stroke (ischemic or hemorrhagic), and satisfied preordained physiologic criteria. Participants were randomized to usual care alone or very early and more frequent mobilization in addition to usual care. Quality of life at 12 months was a prespecified secondary outcome, evaluated using the Assessment of Quality of Life 4D (AQoL-4D). This utility-weighted scale has scores ranging from -0.04 (worse than death) to 1 (perfect health). Participants who died were assigned an AQoL-4D score of 0.
RESULTS


No significant difference in quality of life at 12 months between intervention (median 0.47, interquartile range [IQR] 0.07-0.81) and usual care (median 0.49, IQR 0.08-0.81) groups was identified ( p  = 0.86), nor were there any group differences across the 4 AQoL-4D domains. The same lack of group difference in quality of life was observed at 3 months. When cohort data were analyzed (both groups together), quality of life was strongly associated with acute length of stay, independence in activities of daily living, cognitive function, depressive symptoms, and anxiety symptoms (all  p  < 0.001). Quality of life in AVERT participants was substantially lower than population norms, and the gap increased with age.
CONCLUSIONS


Earlier and more frequent mobilization after stroke did not influence quality of life.
CLINICAL TRIAL REGISTRATION


anzctr.org.au; ACTRN12606000185561 CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for people with stroke, earlier and more frequent mobilization did not influence quality of life over the subsequent year.",2019,"No significant difference in quality of life at 12 months between intervention (median 0.47, interquartile range [IQR] 0.07-0.81) and usual care (median 0.49, IQR 0.08-0.81) groups was identified ( p  = 0.86), nor were there any group differences across the 4 AQoL-4D domains.","['People were included if they were aged ≥18 years, presented within 24 hours of a first or recurrent stroke (ischemic or hemorrhagic), and satisfied preordained physiologic criteria']",['usual care alone or very early and more frequent mobilization in addition to usual care'],"['Early mobilization and quality of life', 'usual care', 'Quality of life', 'quality of life', 'Quality of Life 4D (AQoL-4D', 'acute length of stay, independence in activities of daily living, cognitive function, depressive symptoms, and anxiety symptoms']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0013459', 'cui_str': 'Early Mobilization'}, {'cui': 'C0034380'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",,0.171029,"No significant difference in quality of life at 12 months between intervention (median 0.47, interquartile range [IQR] 0.07-0.81) and usual care (median 0.49, IQR 0.08-0.81) groups was identified ( p  = 0.86), nor were there any group differences across the 4 AQoL-4D domains.","[{'ForeName': 'Toby B', 'Initials': 'TB', 'LastName': 'Cumming', 'Affiliation': 'From Florey Institute of Neuroscience and Mental Health (T.B.C., L.C., J.C., G.D., F.E., J.B.), University of Melbourne; Eastern Health Clinical School (H.D.) and Department of Medicine, School of Clinical Sciences at Monash Health (A.G.T.), Monash University, Melbourne, Australia; Institute of Cardiovascular and Medical Sciences (P.L.), University of Glasgow, UK; Westmead Hospital Clinical School (R.I.L.), University of Sydney and George Institute for Global Health, Sydney; Faculty of Health (M.M.), Deakin University, Melbourne, Australia.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Churilov', 'Affiliation': 'From Florey Institute of Neuroscience and Mental Health (T.B.C., L.C., J.C., G.D., F.E., J.B.), University of Melbourne; Eastern Health Clinical School (H.D.) and Department of Medicine, School of Clinical Sciences at Monash Health (A.G.T.), Monash University, Melbourne, Australia; Institute of Cardiovascular and Medical Sciences (P.L.), University of Glasgow, UK; Westmead Hospital Clinical School (R.I.L.), University of Sydney and George Institute for Global Health, Sydney; Faculty of Health (M.M.), Deakin University, Melbourne, Australia.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Collier', 'Affiliation': 'From Florey Institute of Neuroscience and Mental Health (T.B.C., L.C., J.C., G.D., F.E., J.B.), University of Melbourne; Eastern Health Clinical School (H.D.) and Department of Medicine, School of Clinical Sciences at Monash Health (A.G.T.), Monash University, Melbourne, Australia; Institute of Cardiovascular and Medical Sciences (P.L.), University of Glasgow, UK; Westmead Hospital Clinical School (R.I.L.), University of Sydney and George Institute for Global Health, Sydney; Faculty of Health (M.M.), Deakin University, Melbourne, Australia.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Donnan', 'Affiliation': 'From Florey Institute of Neuroscience and Mental Health (T.B.C., L.C., J.C., G.D., F.E., J.B.), University of Melbourne; Eastern Health Clinical School (H.D.) and Department of Medicine, School of Clinical Sciences at Monash Health (A.G.T.), Monash University, Melbourne, Australia; Institute of Cardiovascular and Medical Sciences (P.L.), University of Glasgow, UK; Westmead Hospital Clinical School (R.I.L.), University of Sydney and George Institute for Global Health, Sydney; Faculty of Health (M.M.), Deakin University, Melbourne, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Ellery', 'Affiliation': 'From Florey Institute of Neuroscience and Mental Health (T.B.C., L.C., J.C., G.D., F.E., J.B.), University of Melbourne; Eastern Health Clinical School (H.D.) and Department of Medicine, School of Clinical Sciences at Monash Health (A.G.T.), Monash University, Melbourne, Australia; Institute of Cardiovascular and Medical Sciences (P.L.), University of Glasgow, UK; Westmead Hospital Clinical School (R.I.L.), University of Sydney and George Institute for Global Health, Sydney; Faculty of Health (M.M.), Deakin University, Melbourne, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dewey', 'Affiliation': 'From Florey Institute of Neuroscience and Mental Health (T.B.C., L.C., J.C., G.D., F.E., J.B.), University of Melbourne; Eastern Health Clinical School (H.D.) and Department of Medicine, School of Clinical Sciences at Monash Health (A.G.T.), Monash University, Melbourne, Australia; Institute of Cardiovascular and Medical Sciences (P.L.), University of Glasgow, UK; Westmead Hospital Clinical School (R.I.L.), University of Sydney and George Institute for Global Health, Sydney; Faculty of Health (M.M.), Deakin University, Melbourne, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Langhorne', 'Affiliation': 'From Florey Institute of Neuroscience and Mental Health (T.B.C., L.C., J.C., G.D., F.E., J.B.), University of Melbourne; Eastern Health Clinical School (H.D.) and Department of Medicine, School of Clinical Sciences at Monash Health (A.G.T.), Monash University, Melbourne, Australia; Institute of Cardiovascular and Medical Sciences (P.L.), University of Glasgow, UK; Westmead Hospital Clinical School (R.I.L.), University of Sydney and George Institute for Global Health, Sydney; Faculty of Health (M.M.), Deakin University, Melbourne, Australia.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': 'From Florey Institute of Neuroscience and Mental Health (T.B.C., L.C., J.C., G.D., F.E., J.B.), University of Melbourne; Eastern Health Clinical School (H.D.) and Department of Medicine, School of Clinical Sciences at Monash Health (A.G.T.), Monash University, Melbourne, Australia; Institute of Cardiovascular and Medical Sciences (P.L.), University of Glasgow, UK; Westmead Hospital Clinical School (R.I.L.), University of Sydney and George Institute for Global Health, Sydney; Faculty of Health (M.M.), Deakin University, Melbourne, Australia.'}, {'ForeName': 'Marj', 'Initials': 'M', 'LastName': 'Moodie', 'Affiliation': 'From Florey Institute of Neuroscience and Mental Health (T.B.C., L.C., J.C., G.D., F.E., J.B.), University of Melbourne; Eastern Health Clinical School (H.D.) and Department of Medicine, School of Clinical Sciences at Monash Health (A.G.T.), Monash University, Melbourne, Australia; Institute of Cardiovascular and Medical Sciences (P.L.), University of Glasgow, UK; Westmead Hospital Clinical School (R.I.L.), University of Sydney and George Institute for Global Health, Sydney; Faculty of Health (M.M.), Deakin University, Melbourne, Australia.'}, {'ForeName': 'Amanda G', 'Initials': 'AG', 'LastName': 'Thrift', 'Affiliation': 'From Florey Institute of Neuroscience and Mental Health (T.B.C., L.C., J.C., G.D., F.E., J.B.), University of Melbourne; Eastern Health Clinical School (H.D.) and Department of Medicine, School of Clinical Sciences at Monash Health (A.G.T.), Monash University, Melbourne, Australia; Institute of Cardiovascular and Medical Sciences (P.L.), University of Glasgow, UK; Westmead Hospital Clinical School (R.I.L.), University of Sydney and George Institute for Global Health, Sydney; Faculty of Health (M.M.), Deakin University, Melbourne, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bernhardt', 'Affiliation': 'From Florey Institute of Neuroscience and Mental Health (T.B.C., L.C., J.C., G.D., F.E., J.B.), University of Melbourne; Eastern Health Clinical School (H.D.) and Department of Medicine, School of Clinical Sciences at Monash Health (A.G.T.), Monash University, Melbourne, Australia; Institute of Cardiovascular and Medical Sciences (P.L.), University of Glasgow, UK; Westmead Hospital Clinical School (R.I.L.), University of Sydney and George Institute for Global Health, Sydney; Faculty of Health (M.M.), Deakin University, Melbourne, Australia. julie.bernhardt@florey.edu.au.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000007937']
741,31637467,A self-emulsifying Omega-3 ethyl ester formulation (AquaCelle) significantly improves eicosapentaenoic and docosahexaenoic acid bioavailability in healthy adults.,"PURPOSE


Application of intelligent formulation design has the ability to address the poor bioavailability and improve the fasted state bioavailability of fish oils. In this study we assessed the ability of a self-emulsifying drug delivery system (SEDDS), AquaCelle ® , as an additive to enhance the oral absorption of Omega-3 ethyl esters (EE) in healthy subjects under low-fat diet conditions.
METHODS


Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) EE were formulated with AquaCelle ® . A single dose (680 mg dose of oil containing 272 mg of EPA EE and 204 mg of DHA EE), randomized, double-blind, study measured uptake of EPA and DHA over 24 h in healthy adults. Participants were randomized into two groups, receiving either the SEDDS AquaCelle ®  fish oil formulation or the unformulated fish oil EE as control.
RESULTS


The AquaCelle ®  fish oil EE formulation demonstrated instant and complete emulsification on addition to water to produce an emulsion with an average diameter of 43 μm, compared to the oil alone which did not emulsify. The study revealed a significant difference in absorption (C max  and AUC 0-24h ) between the AquaCelle ®  group and the control group. The AquaCelle ®  group was capable of increasing maximum plasma concentrations and absorption (AUC 0-24h ) of total Omega-3 (EPA + DHA) 3.7- and 7.1-fold, respectively, compared to the control.
CONCLUSION


Formulating Omega-3 EE with a SEDSS concentrate (AquaCelle ® ) demonstrated a significant improvement in the oral absorption of Omega-3 fatty acids without requiring a high-fat meal.",2020,"The AquaCelle ®  group was capable of increasing maximum plasma concentrations and absorption (AUC 0-24h ) of total Omega-3 (EPA + DHA) 3.7- and 7.1-fold, respectively, compared to the control.
","['healthy subjects under low-fat diet conditions', 'healthy adults']","['Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) EE', 'oil containing 272\xa0mg of EPA EE and 204\xa0mg of DHA EE', 'Formulating Omega-3 EE with a SEDSS concentrate (AquaCelle ® ', 'self-emulsifying drug delivery system (SEDDS), AquaCelle ®', 'Omega-3 ethyl esters (EE', 'self-emulsifying Omega-3 ethyl ester formulation (AquaCelle', 'SEDDS AquaCelle ®  fish oil formulation or the unformulated fish oil EE']","['absorption (C max  and AUC 0-24h ', 'eicosapentaenoic and docosahexaenoic acid bioavailability', 'oral absorption of Omega-3 fatty acids', 'maximum plasma concentrations and absorption (AUC 0-24h ) of total Omega-3 (EPA\u2009+\u2009DHA']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C3884644', 'cui_str': '(trimethylsilyl)ethyl ester'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}]","[{'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}]",,0.0520396,"The AquaCelle ®  group was capable of increasing maximum plasma concentrations and absorption (AUC 0-24h ) of total Omega-3 (EPA + DHA) 3.7- and 7.1-fold, respectively, compared to the control.
","[{'ForeName': 'Kristen E', 'Initials': 'KE', 'LastName': 'Bremmell', 'Affiliation': 'School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, SA, 5000, Australia. Kristen.bremmell@unisa.edu.au.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Briskey', 'Affiliation': 'RDC Clinical Pty Ltd, Brisbane, QLD, 4005, Australia.'}, {'ForeName': 'Tahlia R', 'Initials': 'TR', 'LastName': 'Meola', 'Affiliation': 'School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, SA, 5000, Australia.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Mallard', 'Affiliation': 'School of Human Movement and Nutrition Sciences, University of Queensland, Brisbane, QLD, 4072, Australia.'}, {'ForeName': 'Clive A', 'Initials': 'CA', 'LastName': 'Prestidge', 'Affiliation': 'School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, SA, 5000, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Rao', 'Affiliation': 'RDC Clinical Pty Ltd, Brisbane, QLD, 4005, Australia.'}]",European journal of nutrition,['10.1007/s00394-019-02118-x']
742,31638477,Effects of a short workplace exercise program on body composition in women: A randomized controlled trial.,"Physical inactivity and poor diet cause alterations in body composition, which in turn increases risk factors for cardiovascular and metabolic diseases. Sixty-three women from different work environments were randomly assigned to an intervention ( n  = 34) or control ( n  = 29) group. The intervention was a short-term aerobic exercise program (12 weeks) at their workplace. Participants assigned to the control group did not perform any form of physical exercise. Body composition was measured by dual-energy X-ray absorptiometry (DXA). Diet was assessed using the Mediterranean Diet Quality Questionnaire (KIDMED) and nutrient balance by the Food Frequency Questionnaire. Researchers suggest that a short-term aerobic exercise program produces beneficial effects on body composition.",2020,Participants assigned to the control group did not perform any form of physical exercise.,"['women', 'Sixty-three women from different work environments']","['aerobic exercise program', 'control group did not perform any form of physical exercise', 'short workplace exercise program']","['Body composition', 'Mediterranean Diet Quality Questionnaire (KIDMED) and nutrient balance by the Food Frequency Questionnaire', 'body composition']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",63.0,0.0346824,Participants assigned to the control group did not perform any form of physical exercise.,"[{'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Iturriaga', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Villaviciosa de Odón, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Barcelo', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Villaviciosa de Odón, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Diez-Vega', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Villaviciosa de Odón, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Cordero', 'Affiliation': 'Medical Service, Universidad Europea de Madrid, Villaviciosa de Odón, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Pulgar', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Villaviciosa de Odón, Spain.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Fernandez-Luna', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Villaviciosa de Odón, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Perez-Ruiz', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Villaviciosa de Odón, Spain.'}]",Health care for women international,['10.1080/07399332.2019.1679813']
743,31521872,Whose depression deteriorates during acute phase antidepressant treatment?,"BACKGROUND


Few studies have investigated the proportion of patients with depression who experience worsening of depression symptoms during adequate antidepressant treatment. The current study aimed to investigate the proportion and predictors of worsening depression during antidepressant treatment in a multi-center randomized trial involving patients with major depression.
METHODS


We defined the deterioration of depression using depression symptom severity evaluated by total Patient Health Questionnaire (PHQ-9) score increases from week 0 to week 9 during acute phase antidepressant treatment. Patients' baseline demographic and clinical data, change in PHQ-9 scores from week 0 to week 3, and side effects at week 3 were evaluated as potential predictors of subsequent deterioration of depression.
RESULTS


Of 1,647 patients, 99 (6.0%) exhibited deterioration of depression, and this proportion was smaller when reliable change index criteria were applied. Logistic regression analysis revealed that the following factors were significantly associated with deterioration of depression: younger age at onset of first episode of major depressive disorder, current older age, and greater increase in PHQ-9 scores between week 0 and week 3.
LIMITATIONS


The time of the primary endpoint might not have been sufficiently long. The present study did not include a placebo arm, and potentially relevant predictors might not have been comprehensively investigated.
CONCLUSIONS


A small proportion of patients may experience deterioration of depression during acute phase antidepressant treatment. Age at onset at first depressive episode, current age, and early negative response to antidepressants may be useful predictors of subsequent worsening of depression.",2020,"RESULTS


Of 1,647 patients, 99 (6.0%) exhibited deterioration of depression, and this proportion was smaller when reliable change index criteria were applied.","['patients with depression who experience worsening of depression symptoms during adequate antidepressant treatment', 'patients with major depression']",['placebo'],"['deterioration of depression using depression symptom severity evaluated by total Patient Health Questionnaire (PHQ-9) score', 'PHQ-9 scores', 'deterioration of depression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",1647.0,0.0241433,"RESULTS


Of 1,647 patients, 99 (6.0%) exhibited deterioration of depression, and this proportion was smaller when reliable change index criteria were applied.","[{'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Akechi', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: takechi@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Sugishita', 'Affiliation': 'Oji Mental Clinic.'}, {'ForeName': 'Bun', 'Initials': 'B', 'LastName': 'Chino', 'Affiliation': 'Ginza Taimei Clinic.'}, {'ForeName': 'Kahori', 'Initials': 'K', 'LastName': 'Itoh', 'Affiliation': 'Sinsapporo Mental Clinic.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Ikeda', 'Affiliation': 'Narumi Himawari Clinic.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Shimodera', 'Affiliation': 'Department of Neuropsychiatry, Kochi Medical School.'}, {'ForeName': 'Naohiro', 'Initials': 'N', 'LastName': 'Yonemoto', 'Affiliation': 'Department of Biostatistics, Kyoto University School of Public Health.'}, {'ForeName': 'Kazuhira', 'Initials': 'K', 'LastName': 'Miki', 'Affiliation': 'Miki Mental Clinic.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Ogawa', 'Affiliation': 'Department of Healthcare Epidemiology, School of Public Health in the Graduate School of Medicine, Kyoto University.'}, {'ForeName': 'Nozomi', 'Initials': 'N', 'LastName': 'Takeshima', 'Affiliation': 'Kyoto University Graduate School of Medicine/School of Public Health Department of Health Promotion of Human Behavior.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Aratama Kokorono Clinic.'}, {'ForeName': 'Toshi A', 'Initials': 'TA', 'LastName': 'Furukawa', 'Affiliation': 'Department of Healthcare Epidemiology, School of Public Health in the Graduate School of Medicine, Kyoto University.'}]",Journal of affective disorders,['10.1016/j.jad.2019.09.052']
744,31863497,A Two-way Street: Mentor Stress and Depression Influence Relational Satisfaction and Attachment in Youth Mentoring Relationships.,"Over the past two decades, youth mentoring programs have increased in popularity as an intervention for children exposed to a range of stressful life circumstances. Such programs have been shown to promote positive youth development and reduce risk for emotional and behavioral problems; yet, the effect size of youth gains remains small. The current study examined the influence of college student mentors' history of early life stress and baseline depressive symptoms on their effectiveness in youth mentoring relationships using 340 randomized mentor-youth pairs from College Mentors for Kids, a well-established mentoring program with chapters across the United States. Hierarchical linear models revealed that mentors with higher levels of depressive symptoms reported lower relationship satisfaction and increased avoidance in the mentoring relationship. In contrast, mentors who experienced higher levels of early life stress had youth who reported greater satisfaction in the mentoring relationship and decreased relational anxiety. These findings are some of the first to examine the impact of mentor characteristics on mentor-youth relationships and highlight the importance of considering factors relevant to psychosocial functioning and emotional distress when recruiting, training, and supporting college student mentors.",2020,Hierarchical linear models revealed that mentors with higher levels of depressive symptoms reported lower relationship satisfaction and increased avoidance in the mentoring relationship.,"['youth mentoring relationships using 340 randomized mentor-youth pairs from College Mentors for Kids, a well-established mentoring program with chapters across the United States', 'Youth Mentoring Relationships']",[],['relational anxiety'],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C4255266', 'cui_str': 'Mentoring'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}]",340.0,0.05768,Hierarchical linear models revealed that mentors with higher levels of depressive symptoms reported lower relationship satisfaction and increased avoidance in the mentoring relationship.,"[{'ForeName': 'Emma G', 'Initials': 'EG', 'LastName': 'Preston', 'Affiliation': 'Department of Psychological Sciences, William & Mary, Williamsburg, VA, USA.'}, {'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Raposa', 'Affiliation': 'Department of Psychological Sciences, William & Mary, Williamsburg, VA, USA.'}]",American journal of community psychology,['10.1002/ajcp.12412']
745,30326768,"Impact of a Nurse-Led Health Promotion Intervention in an Aging Population: Results From a Quasi-Experimental Study on the ""Community Health Consultation Offices for Seniors"".","Objective:  The study evaluated the nurse-led intervention "" Community Health Consultation Offices for Seniors (CHCO) "" on health-related and care needs-related outcomes in community-dwelling older people (⩾60 years).  Method:  With a quasi-experimental design, the CHCO intervention was evaluated on health-related and care needs-related outcomes after 1-year follow-up. Older people who received the intervention were frail, overweight, or were smoking. The comparison group received care as usual. In both groups, similar data were collected on health status, falls and fractures, and care needs. In the intervention group, additional data were collected on biometric measures and health-related behavior.  Results:  The intervention group and the care-as-usual group included 403 seniors and 984 seniors, respectively. Health-related outcomes, behaviors, and biometric measures, remained stable. After 1 year, care needs increased for both groups, but at a lower rate for the care-as-usual group.  Discussion:  The CHCO intervention showed no significant improvement on health-related outcomes or stability in care needs-related outcomes.",2020,"After 1 year, care needs increased for both groups, but at a lower rate for the care-as-usual group.
","['With a quasi-experimental design', 'Community Health Consultation Offices for Seniors', 'Aging Population', 'Older people who received the intervention were frail, overweight, or were smoking', 'nurse-led intervention "" Community Health Consultation Offices for Seniors (CHCO)"" on health-related and care needs-related outcomes in community-dwelling older people (⩾60 years']","['CHCO intervention', 'Nurse-Led Health Promotion Intervention']","['biometric measures and health-related behavior', 'Health-related outcomes, behaviors, and biometric measures']","[{'cui': 'C0015320', 'cui_str': 'Experimental Design'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0254728,"After 1 year, care needs increased for both groups, but at a lower rate for the care-as-usual group.
","[{'ForeName': 'Anne Esther', 'Initials': 'AE', 'LastName': 'Marcus-Varwijk', 'Affiliation': 'Windesheim University of Applied Sciences, Research Group Innovating with Older Adults, Zwolle, The Netherlands.'}, {'ForeName': 'Lilian L', 'Initials': 'LL', 'LastName': 'Peters', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of General Practice & Elderly Care Medicine, The Netherlands.'}, {'ForeName': 'Tommy L S', 'Initials': 'TLS', 'LastName': 'Visscher', 'Affiliation': 'Windesheim University of Applied Sciences, Research Group Healthy Cities, Zwolle, The Netherlands.'}, {'ForeName': 'Carolien H M', 'Initials': 'CHM', 'LastName': 'Smits', 'Affiliation': 'Windesheim University of Applied Sciences, Research Group Innovating with Older Adults, Zwolle, The Netherlands.'}, {'ForeName': 'Adelita V', 'Initials': 'AV', 'LastName': 'Ranchor', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Health Psychology Section, The Netherlands.'}, {'ForeName': 'Joris P J', 'Initials': 'JPJ', 'LastName': 'Slaets', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department Internal Medicine, the Netherlands.'}]",Journal of aging and health,['10.1177/0898264318804946']
746,30215273,Effects of Mindfulness-Based Psychoeducation on the Internalized Stigmatization Level of Patients With Schizophrenia.,"The aim of this study was to determine the effects of mindfulness-based psychoeducation on internalized stigma in patients with schizophrenia. The patients were recruited from the community mental health centers. This quasiexperimental study was conducted using pretests and posttests with a control group. The participants were 69 patients with schizophrenia; 34 were part of the experimental group and 35 were part of the control group. The patients in the experimental group participated 2 days a week for 6 weeks in a total of 12 sessions which were given in the form of face-to-face group training. The difference between the scale mean posttest scores of the patients in the experimental and control groups was found to be statistically significant ( p  < .05). In the intragroup comparisons, a significant difference was found between the stigma mean scores in the experimental group ( p  < .05). It was concluded that mindfulness-based psychoeducation was effective in reducing stigma in patients with schizophrenia.",2020,The difference between the scale mean posttest scores of the patients in the experimental and control groups was found to be statistically significant ( p < .05).,"['patients were recruited from the community mental health centers', 'Patients With Schizophrenia', 'patients with schizophrenia', '69 patients with schizophrenia; 34 were part of the experimental group and 35 were part of the control group']","['mindfulness-based psychoeducation', 'Mindfulness-Based Psychoeducation']","['stigma mean scores', 'scale mean posttest scores', 'internalized stigma']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009474', 'cui_str': 'CMHC'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}]",69.0,0.0140148,The difference between the scale mean posttest scores of the patients in the experimental and control groups was found to be statistically significant ( p < .05).,"[{'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Yılmaz', 'Affiliation': 'Bingöl University, Turkey.'}, {'ForeName': 'Funda', 'Initials': 'F', 'LastName': 'Kavak', 'Affiliation': 'Inönü University, Malatya, Turkey.'}]",Clinical nursing research,['10.1177/1054773818797871']
747,31645288,Recurrence of breast cancer after regional or general anaesthesia: a randomised controlled trial.,"BACKGROUND


Three perioperative factors impair host defence against recurrence during cancer surgery: the surgical stress response, use of volatile anaesthetic, and opioids for analgesia. All factors are ameliorated by regional anaesthesia-analgesia. We tested the primary hypothesis that breast cancer recurrence after potentially curative surgery is lower with regional anaesthesia-analgesia using paravertebral blocks and the anaesthetic propofol than with general anaesthesia with the volatile anaesthetic sevoflurane and opioid analgesia. A second hypothesis was that regional anaesthesia-analgesia reduces persistent incisional pain.
METHODS


We did a randomised controlled trial at 13 hospitals in Argentina, Austria, China, Germany, Ireland, New Zealand, Singapore, and the USA. Women (age <85 years) having potentially curative primary breast cancer resections were randomised by computer to either regional anaesthesia-analgesia (paravertebral blocks and propofol) or general anaesthesia (sevoflurane) and opioid analgesia. The primary outcome was local or metastatic breast cancer recurrence. The secondary outcome was incisional pain at 6 months and 12 months. Primary analyses were done under intention-to-treat principles. This trial is registered with ClinicalTrials.gov, NCT00418457. The study was stopped after a preplanned futility boundary was crossed.
FINDINGS


Between Jan 30, 2007, and Jan 18, 2018, 2132 women were enrolled to the study, of whom 24 were excluded before surgery. 1043 were assigned to regional anaesthesia-analgesia and 1065 were allocated to general anaesthesia. Baseline characteristics were well balanced between study groups. Median follow-up was 36 (IQR 24-49) months. Among women assigned regional anaesthesia-analgesia, 102 (10%) recurrences were reported, compared with 111 (10%) recurrences among those allocated general anaesthesia (hazard ratio 0·97, 95% CI 0·74-1·28; p=0·84). Incisional pain was reported by 442 (52%) of 856 patients assigned to regional anaesthesia-analgesia and 456 (52%) of 872 patients allocated to general anaesthesia at 6 months, and by 239 (28%) of 854 patients and 232 (27%) of 852 patients, respectively, at 12 months (overall interim-adjusted odds ratio 1·00, 95% CI 0·85-1·17; p=0·99). Neuropathic breast pain did not differ by anaesthetic technique and was reported by 87 (10%) of 859 patients assigned to regional anaesthesia-analgesia and 89 (10%) of 870 patients allocated to general anaesthesia at 6 months, and by 57 (7%) of 857 patients and 57 (7%) of 854 patients, respectively, at 12 months.
INTERPRETATION


In our study population, regional anaesthesia-analgesia (paravertebral block and propofol) did not reduce breast cancer recurrence after potentially curative surgery compared with volatile anaesthesia (sevoflurane) and opioids. The frequency and severity of persistent incisional breast pain was unaffected by anaesthetic technique. Clinicians can use regional or general anaesthesia with respect to breast cancer recurrence and persistent incisional pain.
FUNDING


Sisk Healthcare Foundation (Ireland), Eccles Breast Cancer Research Fund, British Journal of Anaesthesia International, College of Anaesthetists of Ireland, Peking Union Medical College Hospital, Science Fund for Junior Faculty 2016, Central Bank of Austria, and National Healthcare Group.",2019,"recurrences among those allocated general anaesthesia (hazard ratio 0·97, 95% CI 0·74-1·28; p=0·84).","['13 hospitals in Argentina, Austria, China, Germany, Ireland, New Zealand, Singapore, and the USA', '859 patients assigned to regional anaesthesia-analgesia and 89 (10%) of 870 patients allocated to', 'Recurrence of breast cancer after regional or general anaesthesia', 'Women (age <85 years) having potentially curative primary breast cancer resections', 'Between Jan 30, 2007, and Jan 18, 2018, 2132 women were enrolled to the study, of whom 24 were excluded before surgery', 'cancer surgery']","['anaesthetic propofol', 'regional anaesthesia-analgesia (paravertebral block and propofol', 'general anaesthesia', 'volatile anaesthesia (sevoflurane) and opioids', 'regional anaesthesia-analgesia (paravertebral blocks and propofol) or general anaesthesia (sevoflurane) and opioid analgesia', 'regional anaesthesia-analgesia']","['breast cancer recurrence', 'Incisional pain', 'Neuropathic breast pain', 'incisional pain', 'frequency and severity of persistent incisional breast pain', 'local or metastatic breast cancer recurrence']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022067', 'cui_str': 'Ireland, Republic of'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0002911', 'cui_str': 'Anesthesia, Regional'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0920424'}]","[{'cui': 'C0002932', 'cui_str': 'Anesthetic Drugs'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002911', 'cui_str': 'Anesthesia, Regional'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C1963547', 'cui_str': 'Volatile'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024902', 'cui_str': 'Mammalgia'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}]",1043.0,0.227467,"recurrences among those allocated general anaesthesia (hazard ratio 0·97, 95% CI 0·74-1·28; p=0·84).","[{'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Department of Outcomes Research, Anesthesiology Institute and Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA. Electronic address: ds@or.org.'}, {'ForeName': 'Lijian', 'Initials': 'L', 'LastName': 'Pei', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Yuguang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China. Electronic address: garybeijing@163.com.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Fleischmann', 'Affiliation': 'Department of Anaesthesia, General Intensive Care and Pain Management, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Marhofer', 'Affiliation': 'Department of Anaesthesia, General Intensive Care and Pain Management, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kurz', 'Affiliation': 'Department of Outcomes Research, Anesthesiology Institute and Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA; Department of General Anesthesiology, Anesthesiology Institute and Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'Mayers', 'Affiliation': 'Department of Outcomes Research, Anesthesiology Institute and Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA; Department of Regional Anesthesiology, Anesthesiology Institute and Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Tanja A', 'Initials': 'TA', 'LastName': 'Meyer-Treschan', 'Affiliation': 'Department of Anesthesiology, University of Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Grady', 'Affiliation': 'Department of Outcomes Research, Anesthesiology Institute and Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA; Department of Regional Anesthesiology, Anesthesiology Institute and Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Ern Yu', 'Initials': 'EY', 'LastName': 'Tan', 'Affiliation': 'Tan Tock Seng Hospital, Singapore, Singapore.'}, {'ForeName': 'Sabry', 'Initials': 'S', 'LastName': 'Ayad', 'Affiliation': 'Department of Outcomes Research, Anesthesiology Institute and Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA; Department of Regional Anesthesiology, Anesthesiology Institute and Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Mascha', 'Affiliation': 'Department of Outcomes Research, Anesthesiology Institute and Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA; Department of Quantitative Health Sciences, Anesthesiology Institute and Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Donal J', 'Initials': 'DJ', 'LastName': 'Buggy', 'Affiliation': 'Mater University Hospital, School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)32313-X']
748,30501478,Predictors of Long-Term Improvement in Subjective Everyday Memory Following a Memory Group Program for Older Adults.,"Objective:  The present study aimed to examine predictors of improvement in subjective everyday memory ability 5 years following participation in a group cognitive-behavioral memory intervention for community-living older adults, the La Trobe and Caulfield Hospital (LaTCH) Memory Group program.  Method:  Participants were 61 healthy older adults and data were analyzed using one-way repeated measures analysis of variance (ANOVA), hierarchical regression, and moderator analyses.  Results:  Although the group as a whole did not show significant gains in subjective memory ability following the intervention, greater gains in subjective memory ability were associated with poorer baseline associative memory, better baseline cognitive flexibility, and more subjective memory concerns prior to intervention. There was no interaction between the cognitive predictors and subjective memory concerns in predicting gains in subjective memory ability.  Discussion:  Differential benefits for more cognitively flexible individuals may derive from a greater capacity to engage skillfully in the expectancy modification aspects of the program.",2020,"Although the group as a whole did not show significant gains in subjective memory ability following the intervention, greater gains in subjective memory ability were associated with poorer baseline associative memory, better baseline cognitive flexibility, and more subjective memory concerns prior to intervention.","['community-living older adults, the La Trobe and Caulfield Hospital (LaTCH) Memory Group program', 'Older Adults', 'Participants were 61 healthy older adults']",['cognitive-behavioral memory intervention'],"['Subjective Everyday Memory', 'subjective memory ability']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",61.0,0.0152165,"Although the group as a whole did not show significant gains in subjective memory ability following the intervention, greater gains in subjective memory ability were associated with poorer baseline associative memory, better baseline cognitive flexibility, and more subjective memory concerns prior to intervention.","[{'ForeName': 'Milanda L', 'Initials': 'ML', 'LastName': 'Matthews', 'Affiliation': 'La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Kerryn E', 'Initials': 'KE', 'LastName': 'Pike', 'Affiliation': 'La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Wright', 'Affiliation': 'La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Glynda J', 'Initials': 'GJ', 'LastName': 'Kinsella', 'Affiliation': 'La Trobe University, Melbourne, Australia.'}]",Journal of aging and health,['10.1177/0898264318814997']
749,29642095,"Efficacy of Intra-articular Polynucleotides Associated With Hyaluronic Acid Versus Hyaluronic Acid Alone in the Treatment of Knee Osteoarthritis: A Randomized, Double-Blind, Controlled Clinical Trial.","OBJECTIVE


Pain and range of motion loss are the main clinical features of osteoarthritis (OA). Hyaluronic acid (HA) is one of the infiltrative therapies for OA treatment; however, its effectiveness is a matter of an ongoing debate in clinical practice. Polynucleotides (PNs), a DNA-derived macromolecule with natural origin and trophic activity, were found to favor cell growth and collagen production, in preclinical and clinical studies regarding cartilage regeneration. This study aimed at evaluating whether injection of PNs, in combination with HA [PNs associated with HA (PNHA)], can ameliorate pain and function of knees affected by OA, more than HA alone.
DESIGN


A randomized, double-blind, controlled clinical trial.
PATIENTS


The study enrolled 100 patients, then randomized to receive PNHA or HA alone (3 weekly knee I.A. injections).
INTERVENTIONS AND MAIN OUTCOME MEASURES


Pain reduction, decrease of proinflammatory synovial fluid (SF) factors, and improvement in knee function were evaluated by Knee Society Score and WOMAC scores, after 2, 6, and 12 months and by biochemical and immunoenzymatic analyses of SF at the end of the treatment.
RESULTS


Knee Society Score total score and pain item significantly ameliorated in both groups, showing better results in PNHA- than in the HA-treated group. A significant reduction in the WOMAC score was observed over time for both groups. No significant adverse events were reported in either group.
CONCLUSIONS


These findings suggest that I.A. injection of PNs, in combination with HA, is more effective in improving knee function and pain, in a joint affected by OA, compared with HA alone.",2018,"RESULTS


Knee Society Score total score and pain item significantly ameliorated in both groups, showing better results in PNHA- than in the HA-treated group.","['Knee Osteoarthritis', '100 patients']","['HA [PNs associated with HA (PNHA', 'Hyaluronic acid (HA', 'PNHA or HA alone', 'Hyaluronic Acid Versus Hyaluronic Acid Alone']","['Knee Society Score total score and pain item', 'knee function and pain', 'adverse events', 'WOMAC score', 'Knee Society Score and WOMAC scores', 'Pain reduction, decrease of proinflammatory synovial fluid (SF) factors, and improvement in knee function']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0039097', 'cui_str': 'Synovia'}]",100.0,0.245541,"RESULTS


Knee Society Score total score and pain item significantly ameliorated in both groups, showing better results in PNHA- than in the HA-treated group.","[{'ForeName': 'Dante', 'Initials': 'D', 'LastName': 'Dallari', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Sabbioni', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Nicolandrea', 'Initials': 'N', 'LastName': 'Del Piccolo', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Carubbi', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Veronesi', 'Affiliation': 'Laboratory of Preclinical and Surgical Studies, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Torricelli', 'Affiliation': 'Laboratory of Preclinical and Surgical Studies, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Fini', 'Affiliation': 'Laboratory of Preclinical and Surgical Studies, Rizzoli Orthopedic Institute, Bologna, Italy.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000569']
750,29545253,Randomized Assessment of the Safety and Efficacy of Intra-Arterial Infusion of Autologous Stem Cells in Subacute Ischemic Stroke.,"BACKGROUND AND PURPOSE


Stroke is a debilitating illness for which treatment window is limited. Most patients present to the healthcare facility beyond that window. Autologous stem cells have shown some promise for this group of patients. This study was performed to evaluate the safety and the efficacy of intra-arterial infusion of bone marrow-derived mononuclear cells in patients with middle cerebral artery ischemic stroke.
MATERIALS AND METHODS


A prospective, randomized, open-label, blinded-end point study was performed from July 2015 to June 2016. Of 229 patients with acute stroke who presented to the hospital during this period, 20 patients who satisfied the inclusion/exclusion criteria were included and randomized into the control and intervention groups. Intra-arterial stem cell infusion into the ipsilateral MCA was performed in the patients in the intervention group at 8-15 days post-stroke ictus. Final analysis at 6 months was performed for primary (safety) and secondary outcomes (efficacy).
RESULTS


When we compared the primary end point of the study, no procedure-related mortality, complication, new infarct, or symptomatic intracranial hemorrhage was seen in the intervention group. When we compared the secondary end point of good clinical outcome, 8 (80%) patients in the intervention group showed good clinical outcome (modified Rankin Scale score < 2) with 4 (40%) patients in the control group achieving this (95% confidence interval for good outcome in patients with stem cell infusion, 49.03-94.3, and without stem cell infusion, 16.82-68.73;  P  = .068).
CONCLUSIONS


Intra-arterial infusion of stem cells can be carried out safely in the subacute stage of ischemic stroke. Improved clinical outcomes were observed with intra-arterial stem cell therapy; however, studies with larger cohorts are needed to validate the results.",2018,"patients in the control group achieving this (95% confidence interval for good outcome in patients with stem cell infusion, 49.03-94.3, and without stem cell infusion, 16.82-68.73;  P  = .068).
","['July 2015 to June 2016', 'patients with middle cerebral artery ischemic stroke', 'Subacute Ischemic Stroke', '229 patients with acute stroke who presented to the hospital during this period, 20 patients who satisfied the inclusion/exclusion criteria']","['Autologous stem cells', 'intra-arterial infusion of bone marrow-derived mononuclear cells', 'Intra-Arterial Infusion of Autologous Stem Cells']","['good clinical outcome (modified Rankin Scale score', 'mortality, complication, new infarct, or symptomatic intracranial hemorrhage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0021439', 'cui_str': 'Infusions, Intraarterial'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0007634', 'cui_str': 'Cells'}]","[{'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}]",229.0,0.0982326,"patients in the control group achieving this (95% confidence interval for good outcome in patients with stem cell infusion, 49.03-94.3, and without stem cell infusion, 16.82-68.73;  P  = .068).
","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Bhatia', 'Affiliation': 'From the Departments of Radiodiagnosis (V.B., V.G., N.K.).'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'From the Departments of Radiodiagnosis (V.B., V.G., N.K.) drvivekgupta.pgi@gmail.com.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Khurana', 'Affiliation': 'Neurology (D.K.).'}, {'ForeName': 'R R', 'Initials': 'RR', 'LastName': 'Sharma', 'Affiliation': 'Transfusion Medicine (R.R.S.), Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Khandelwal', 'Affiliation': 'From the Departments of Radiodiagnosis (V.B., V.G., N.K.).'}]",AJNR. American journal of neuroradiology,['10.3174/ajnr.A5586']
751,31518440,Clinical evaluation of injectable platelet-rich fibrin with connective tissue graft for the treatment of deep gingival recession defects: A controlled randomized clinical trial.,"AIM


The aim of this study was to determine whether the combined connective tissue graft (CTG) with injectable platelet-rich fibrin (i-PRF) with coronally advanced flap (CAF) improved root coverage of deep Miller Class I or II gingival recessions compared with CTG alone with CAF.
MATERIAL AND METHODS


Seventy-two patients with Miller class I and II gingival recessions were enrolled. Thirty-six patients were randomly assigned to the test group (CAF+CTG+i-PRF [700 rpm for 3 min]) or control group (CAF+CTG). Clinical evaluations were made at 6 months.
RESULTS


At 6 months, complete root coverage was obtained at 88% of the sites treated with CAF+CTG+i-PRF and 80% of the sites treated with CAF+CTG. Difference between the two groups was not statistically significant. At 6 months, the recession depth (RD) reduction and increase in keratinized tissue height (KTH) of the test sites were significantly better compared with the control sites.
CONCLUSIONS


According to the results, the addition of i-PRF to the CAF+CTG treatment showed further development in terms of increasing the KTH and decreasing RD. However, this single trial is not sufficient to advocate the true clinical effect of i-PRF on recession treatment with CAF+CTG and additional trials are needed.",2020,"At 6 months, complete root coverage was obtained at 88% of the sites treated with CAF+CTG+i-prf and 80% of the sites treated with CAF+CTG.","['deep gingival recession defects', 'Seventy-two patients with Miller class I and II gingival recessions were enrolled', 'Thirty-six patients']","['test group [CAF+CTG+i-prf (700rpm for 3min)] or control group [CAF+CTG', 'combined connective tissue graft (CTG) with injectable platelet rich fibrin (i-prf) with coronally advanced flap (CAF', 'CAF+CTG', 'CTG alone with CAF', 'injectable platelet rich fibrin with connective tissue graft']","['recession depth (RD) reduction and increase in keratinized tissue height (KTH', 'complete root coverage', 'KTH and decreasing RD']","[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0017572', 'cui_str': 'Gingival Recession'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0402830', 'cui_str': 'Miller (occupation)'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033374', 'cui_str': 'Prolactin-Releasing Peptide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0009780', 'cui_str': 'Connective Tissue'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C4505052', 'cui_str': 'L-PRF'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}]","[{'cui': 'C0333047', 'cui_str': 'Recession (morphologic abnormality)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",72.0,0.0274785,"At 6 months, complete root coverage was obtained at 88% of the sites treated with CAF+CTG+i-prf and 80% of the sites treated with CAF+CTG.","[{'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Ucak Turer', 'Affiliation': 'Department of Periodontology, Cukurova University, Adana, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Ozcan', 'Affiliation': 'Department of Periodontology, Cukurova University, Adana, Turkey.'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Alkaya', 'Affiliation': 'Department of Periodontology, Cukurova University, Adana, Turkey.'}, {'ForeName': 'Seren', 'Initials': 'S', 'LastName': 'Surmeli', 'Affiliation': 'Department of Periodontology, Cukurova University, Adana, Turkey.'}, {'ForeName': 'Gulsah', 'Initials': 'G', 'LastName': 'Seydaoglu', 'Affiliation': 'Department of Biostatistics, Cukurova University, Adana, Turkey.'}, {'ForeName': 'Mehmet Cenk', 'Initials': 'MC', 'LastName': 'Haytac', 'Affiliation': 'Department of Periodontology, Cukurova University, Adana, Turkey.'}]",Journal of clinical periodontology,['10.1111/jcpe.13193']
752,31876880,Response to: Mitomycin C-augmented Phacotrabeculectomy Versus Phacoemulsification in Primary Angle-closure Glaucoma: A Randomized Controlled Study.,,2020,,['Primary Angle Closure Glaucoma'],['Mitomycin C-augmented Phacotrabeculectomy versus Phacoemulsification'],['Response'],"[{'cui': 'C0017606', 'cui_str': 'Primary angle-closure glaucoma (disorder)'}]","[{'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1167708', 'cui_str': 'Phacotrabeculectomy'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}]",[],,0.0753421,,"[{'ForeName': 'Yasmine M', 'Initials': 'YM', 'LastName': 'El Sayed', 'Affiliation': 'Department of Ophthalmology, Kasr Al-Ainy School of Medicine, Cairo University Cairo, Egypt.'}, {'ForeName': 'Abdelrahman M', 'Initials': 'AM', 'LastName': 'Elhusseiny', 'Affiliation': ''}, {'ForeName': 'Ahmed S', 'Initials': 'AS', 'LastName': 'Albalkini', 'Affiliation': ''}, {'ForeName': 'Reem H', 'Initials': 'RH', 'LastName': 'El Sheikh', 'Affiliation': ''}, {'ForeName': 'Mona A', 'Initials': 'MA', 'LastName': 'Osman', 'Affiliation': ''}]",Journal of glaucoma,['10.1097/IJG.0000000000001434']
753,31641767,"Oral vs Intravenous Antibiotics for Patients With Klebsiella pneumoniae Liver Abscess: A Randomized, Controlled Noninferiority Study.","BACKGROUND


Klebsiella pneumoniae liver abscess (KLA) is emerging worldwide due to hypermucoviscous strains with a propensity for metastatic infection. Treatment includes drainage and prolonged intravenous antibiotics. We aimed to determine whether oral antibiotics were noninferior to continued intravenous antibiotics for KLA.
METHODS


This noninferiority, parallel group, randomized, clinical trial recruited hospitalized adults with liver abscess and K. pneumoniae isolated from blood or abscess fluid who had received ≤7 days of effective antibiotics at 3 sites in Singapore. Patients were randomized 1:1 to oral (ciprofloxacin) or intravenous (ceftriaxone) antibiotics for 28 days. If day 28 clinical response criteria were not met, further oral antibiotics were prescribed until clinical response was met. The primary endpoint was clinical cure assessed at week 12 and included a composite of absence of fever in the preceding week, C-reactive protein <20 mg/L, and reduction in abscess size. A noninferiority margin of 12% was used.
RESULTS


Between November 2013 and October 2017, 152 patients (mean age, 58.7 years; 25.7% women) were recruited, following a median 5 days of effective intravenous antibiotics. A total of 106 (69.7%) underwent abscess drainage; 71/74 (95.9%) randomized to oral antibiotics met the primary endpoint compared with 72/78 (92.3%) randomized to intravenous antibiotics (risk difference, 3.6%; 2-sided 95% confidence interval, -4.9% to 12.8%). Effects were consistent in the per-protocol population. Nonfatal serious adverse events occurred in 12/72 (16.7%) in the oral group and 13/77 (16.9%) in the intravenous group.
CONCLUSIONS


Oral antibiotics were noninferior to intravenous antibiotics for the early treatment of KLA.
CLINICAL TRIALS REGISTRATION


NCT01723150.",2020,"Nonfatal serious adverse events occurred in 12/72 (16.7%) in the oral group and 13/77 (16.9%) in the intravenous group.
","['Klebsiella pneumoniae liver abscess (KLA', 'hospitalized adults with liver abscess and K. pneumoniae isolated from blood or abscess fluid who had received ≤7 days of effective antibiotics at 3 sites in Singapore', 'Between November 2013 and October 2017, 152 patients (mean age, 58.7 years; 25.7% women', 'Patients With Klebsiella pneumoniae Liver Abscess']","['Oral vs Intravenous Antibiotics', 'oral (ciprofloxacin) or intravenous (ceftriaxone) antibiotics', 'intravenous antibiotics']","['clinical cure', 'abscess size', 'Nonfatal serious adverse events', 'composite of absence of fever']","[{'cui': 'C0001699', 'cui_str': 'Klebsiella pneumoniae'}, {'cui': 'C0023885', 'cui_str': 'Abscess, Hepatic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0277797', 'cui_str': 'Apyrexial'}]",152.0,0.200811,"Nonfatal serious adverse events occurred in 12/72 (16.7%) in the oral group and 13/77 (16.9%) in the intravenous group.
","[{'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Molton', 'Affiliation': 'Division of Infectious Diseases, University Medicine Cluster, National University Hospital, Singapore.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Chan', 'Affiliation': 'Infectious Diseases Department, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Kalimuddin', 'Affiliation': 'Department of Infectious Diseases, Singapore General Hospital, Singapore.'}, {'ForeName': 'Jolene', 'Initials': 'J', 'LastName': 'Oon', 'Affiliation': 'Division of Infectious Diseases, University Medicine Cluster, National University Hospital, Singapore.'}, {'ForeName': 'Barnaby E', 'Initials': 'BE', 'LastName': 'Young', 'Affiliation': 'Infectious Diseases Department, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Jenny G', 'Initials': 'JG', 'LastName': 'Low', 'Affiliation': 'Department of Infectious Diseases, Singapore General Hospital, Singapore.'}, {'ForeName': 'Brenda M A', 'Initials': 'BMA', 'LastName': 'Salada', 'Affiliation': 'Division of Infectious Diseases, University Medicine Cluster, National University Hospital, Singapore.'}, {'ForeName': 'Tau Hong', 'Initials': 'TH', 'LastName': 'Lee', 'Affiliation': 'Infectious Diseases Department, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Wijaya', 'Affiliation': 'Department of Infectious Diseases, Singapore General Hospital, Singapore.'}, {'ForeName': 'Dale A', 'Initials': 'DA', 'LastName': 'Fisher', 'Affiliation': 'Division of Infectious Diseases, University Medicine Cluster, National University Hospital, Singapore.'}, {'ForeName': 'Ezlyn', 'Initials': 'E', 'LastName': 'Izharuddin', 'Affiliation': 'Infectious Diseases Department, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Tse Hsien', 'Initials': 'TH', 'LastName': 'Koh', 'Affiliation': 'Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Jeanette W P', 'Initials': 'JWP', 'LastName': 'Teo', 'Affiliation': 'Department of Laboratory Medicine, Microbiology Unit, National University Hospital, Singapore.'}, {'ForeName': 'Prabha Unny', 'Initials': 'PU', 'LastName': 'Krishnan', 'Affiliation': 'Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore.'}, {'ForeName': 'Bien Peng', 'Initials': 'BP', 'LastName': 'Tan', 'Affiliation': 'Diagnostic Radiology, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Winston W L', 'Initials': 'WWL', 'LastName': 'Woon', 'Affiliation': 'Hepato-Pancreato-Biliary Surgery Service, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Infectious Diseases Department, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Singapore Clinical Research Institute, Singapore.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Phillips', 'Affiliation': 'School of Public Health, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Moorakonda', 'Affiliation': 'Singapore Clinical Research Institute, Singapore.'}, {'ForeName': 'Kah Hung', 'Initials': 'KH', 'LastName': 'Yuen', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Boon Piang', 'Initials': 'BP', 'LastName': 'Cher', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Yoong', 'Affiliation': 'Center for Economic and Social Research, University of Southern California, Los Angeles, California.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Lye', 'Affiliation': 'Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Archuleta', 'Affiliation': 'Division of Infectious Diseases, University Medicine Cluster, National University Hospital, Singapore.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz881']
754,31625658,Feasibility of a school-based exercise intervention for children with intellectual disability to reduce cardio-metabolic risk.,"BACKGROUND


People with intellectual disabilities (ID) are at increased risk of secondary health conditions, reduced quality of life and life expectancy. Children with ID demonstrate low levels of physical activity in association with a higher prevalence of obesity, a modifiable risk factor associated with secondary health conditions including type 2 diabetes and cardiovascular disease. Despite this, physical activity interventions addressing weight and weight-related complications in this population are limited. This study aimed to establish the feasibility of a school-based group exercise intervention for children with moderate to severe ID.
METHODS


A single-arm intervention study was used to establish the feasibility of a 16-week exercise intervention. Children attending a School for Specific Purposes in Sydney, Australia, participated in two 30-min exercise sessions per week across the intervention period in addition to their regular physical education class. Each exercise session was 60% aerobically based, 20% strength based and 20% targeted towards fundamental movement skill development. We used two facilitation strategies to assist the delivery of the intervention, including the implementation of a variety of communication resources and promotion of social interaction. Feasibility was assessed through recruitment rates, program retention, adverse effects, attendance, group size feasibility and non-compliance. Anthropometric measures included height (m), weight (kg) and waist circumference (cm; umbilicus), with body mass index (BMI) and waist-to-height ratios (WtHR) used to determine cardio-metabolic risk. Aerobic capacity was assessed using the submaximal 6-min walk test (6-MWT). Intensity of physical activity sessions was measured through the use of tri-axial accelerometers and compared to physical activity recommendations.
RESULTS


Ten children aged between 9 and 13 years completed the 16-week intervention, with a 55% recruitment rate, 91% program retention, 86% attendance and with no adverse effects reported. Sessions commenced as 1:1 supervisor to child ratios before progressing to established small groups of 2:7 (supervisor : child). Children spent 38.4% (11.5 min) of each session in moderate to vigorous physical activity (MVPA), equating to 20% of their MVPA recommended daily physical activity levels (twice per week). There was a significant change in weight across the intervention period, with a trend towards increased weight between mid-intervention and 3-month follow-up time points. There were no significant changes in child BMI, WtHR or aerobic capacity.
CONCLUSIONS


A school-based group exercise intervention for children with moderate to severe ID is feasible and safe, with high retention rates and physical activity participation. No significant improvements in body composition or aerobic capacity were determined. The present study demonstrates that engaging children with moderate-severe ID in school-based group exercise is feasible to assist in physical activity participation.",2020,No significant improvements in body composition or aerobic capacity were determined.,"['children with moderate to severe ID', 'engaging children with moderate-severe ID in school-based group', 'Ten children aged between 9 and 13\xa0years', 'Children attending a School for Specific Purposes in Sydney, Australia', 'People with intellectual disabilities (ID', 'children with intellectual disability to reduce cardio-metabolic risk']","['school-based group exercise intervention', 'exercise', 'school-based exercise intervention', 'exercise intervention']","['Aerobic capacity', 'Intensity of physical activity sessions', 'daily physical activity levels', 'child BMI, WtHR or aerobic capacity', 'body composition or aerobic capacity', 'Anthropometric measures included height (m), weight (kg) and waist circumference (cm; umbilicus), with body mass index (BMI) and waist-to-height ratios (WtHR', 'weight', 'submaximal 6-min walk test (6-MWT', 'recruitment rates, program retention, adverse effects, attendance, group size feasibility and non-compliance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C3714756', 'cui_str': 'Intellectual Development Disorder'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1276393', 'cui_str': 'Group exercise (regime/therapy)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0041638', 'cui_str': 'Umbilicus'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1821269', 'cui_str': 'Height-Weight Ratio'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0457432', 'cui_str': 'Non-compliant (qualifier value)'}]",10.0,0.0268315,No significant improvements in body composition or aerobic capacity were determined.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bellamy', 'Affiliation': 'Faculty of Medicine, School of Medical Sciences, Department of Exercise Physiology, UNSW Sydney, New South Wales, Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Broderick', 'Affiliation': 'Faculty of Medicine, School of Medical Sciences, Department of Exercise Physiology, UNSW Sydney, New South Wales, Australia.'}, {'ForeName': 'L L', 'Initials': 'LL', 'LastName': 'Hardy', 'Affiliation': 'Prevention Research Collaboration, The University of Sydney, New South Wales, Australia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Simar', 'Affiliation': 'Faculty of Medicine, School of Medical Sciences, Department of Exercise Physiology, UNSW Sydney, New South Wales, Australia.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Puusepp-Benazzouz', 'Affiliation': ""The Children's Hospital at Westmead, New South Wales, Australia.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ong', 'Affiliation': ""The Children's Hospital at Westmead, New South Wales, Australia.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Silove', 'Affiliation': ""The Children's Hospital at Westmead, New South Wales, Australia.""}]",Journal of intellectual disability research : JIDR,['10.1111/jir.12690']
755,31523057,Understanding of prognosis in non-metastatic prostate cancer: a randomised comparative study of clinician estimates measured against the PREDICT prostate prognostic model.,"PREDICT Prostate is an individualised prognostic model that provides long-term survival estimates for men diagnosed with non-metastatic prostate cancer ( www.prostate.predict.nhs.uk ). In this study clinician estimates of survival were compared against model predictions and its potential value as a clinical tool was assessed. Prostate cancer (PCa) specialists were invited to participate in the study. 190 clinicians (63% urologists, 17% oncologists, 20% other) were randomised into two groups and shown 12 clinical vignettes through an online portal. Each group viewed opposing vignettes with clinical information alone, or alongside PREDICT Prostate estimates. 15-year clinician survival estimates were compared against model predictions and reported treatment recommendations with and without seeing PREDICT estimates were compared. 155 respondents (81.6%) reported counselling new PCa patients at least weekly. Clinician estimates of PCa-specific mortality exceeded PREDICT estimates in 10/12 vignettes. Their estimates for treatment survival benefit at 15 years were over-optimistic in every vignette, with mean clinician estimates more than 5-fold higher than PREDICT Prostate estimates. Concomitantly seeing PREDICT Prostate estimates led to significantly lower reported likelihoods of recommending radical treatment in 7/12 (58%) vignettes, particularly in older patients. These data suggest clinicians overestimate cancer-related mortality and radical treatment benefit. Using an individualised prognostic tool may help reduce overtreatment.",2019,PREDICT Prostate is an individualised prognostic model that provides long-term survival estimates for men diagnosed with non-metastatic prostate cancer ( www.prostate.predict.nhs.uk ).,"['non-metastatic prostate cancer', 'Prostate cancer (PCa) specialists', 'men diagnosed with non-metastatic prostate cancer ( www.prostate.predict.nhs.uk ', '190 clinicians (63% urologists, 17% oncologists, 20% other']",[],"['PCa-specific mortality', '15-year clinician survival estimates']","[{'cui': 'C1282496', 'cui_str': 'Metastasis from malignant tumor of prostate'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0260314', 'cui_str': 'Urologists'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}]",[],"[{'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",,0.0282638,PREDICT Prostate is an individualised prognostic model that provides long-term survival estimates for men diagnosed with non-metastatic prostate cancer ( www.prostate.predict.nhs.uk ).,"[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Thurtle', 'Affiliation': 'Academic Urology Group, University of Cambridge, Cambridge, UK. dt433@cam.ac.uk.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Jenkins', 'Affiliation': 'Sussex Health Outcomes Research & Education in Cancer, University of Sussex, Brighton, UK.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Pharoah', 'Affiliation': 'Centre for Cancer Genetic Epidemiology, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Gnanapragasam', 'Affiliation': 'Academic Urology Group, University of Cambridge, Cambridge, UK.'}]",British journal of cancer,['10.1038/s41416-019-0569-4']
756,31639195,Postoperative Venous Thromboembolism Prophylaxis Utilizing Enoxaparin Does Not Increase Bleeding Complications After Abdominal Body Contouring Surgery.,"BACKGROUND


Venous thromboembolism (VTE) chemoprophylaxis warrants an individualized, risk-stratified approach, and constitutes a relatively controversial topic in plastic surgery.
OBJECTIVES


The aim of this study was to determine the safety of a 7-day postoperative enoxaparin regimen for VTE prophylaxis compared with a single preoperative dose of heparin in abdominal body contouring surgery.
METHODS


This single-institution pre-post study investigated the safety of a 7-day enoxaparin postoperative regimen in abdominal body contouring procedures performed by a single surgeon from 2007 to 2018. Four procedures were included: traditional panniculectomy, abdominoplasty, fleur-de-lis panniculectomy, and body contouring liposuction. Group I patients received a single dose of 5000 U subcutaneous heparin in the preoperative period, and no postoperative chemical prophylaxis was administered. Group II patients received 40 mg subcutaneous enoxaparin in the immediate preoperative period, then once daily for 7 days postoperatively.
RESULTS


A total of 195 patients were included in the study, 66 in Group I and 129 in Group II. The groups demonstrated statistically similar VTE risk profiles, based on the 2005 Caprini risk-assessment model. There were no statistically significant differences in the 2 primary outcomes: postoperative bleeding and VTE events. Group I patients had higher reoperation rates (22.7% vs 10.1%, P = 0.029), which was secondary to higher rates of revision procedures.
CONCLUSIONS


A 7-day postoperative course of once-daily enoxaparin for VTE risk reduction in abdominal body contouring surgery does not significantly increase the risk of bleeding. Implementation of this regimen for postdischarge chemoprophylaxis, when indicated following individualized risk stratification, is appropriate.
LEVEL OF EVIDENCE: 4


",2020,"Group I patients had higher reoperation rates (22.7 percent versus 10.1 percent, p = 0.029), which was secondary to higher rates of revision procedures.
","['abdominal body contouring procedures performed by a single surgeon from 2007 to 2018', 'A total of 195 patients were included in the study, 66 in Group I and 129 in Group II', 'Four procedures were included: traditional panniculectomy, abdominoplasty, fleur-de-lis panniculectomy, and body contouring liposuction']","['heparin', 'Enoxaparin', 'enoxaparin', '40 mg subcutaneous enoxaparin']","['reoperation rates', 'risk of bleeding', 'postoperative bleeding and VTE events', 'VTE risk profiles', 'Bleeding Complications']","[{'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C2713286', 'cui_str': 'Panniculectomy'}, {'cui': 'C0198542', 'cui_str': 'Abdominoplasty'}, {'cui': 'C0038640', 'cui_str': 'Aspiration Lipectomy'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",195.0,0.111892,"Group I patients had higher reoperation rates (22.7 percent versus 10.1 percent, p = 0.029), which was secondary to higher rates of revision procedures.
","[{'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Vasilakis', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY.'}, {'ForeName': 'Gabriel M', 'Initials': 'GM', 'LastName': 'Klein', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Trostler', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY.'}, {'ForeName': 'Muntazim', 'Initials': 'M', 'LastName': 'Mukit', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY.'}, {'ForeName': 'Jocellie E', 'Initials': 'JE', 'LastName': 'Marquez', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY.'}, {'ForeName': 'Alexander B', 'Initials': 'AB', 'LastName': 'Dagum', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Pannucci', 'Affiliation': 'Division of Plastic Surgery, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Sami U', 'Initials': 'SU', 'LastName': 'Khan', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY.'}]",Aesthetic surgery journal,['10.1093/asj/sjz274']
757,29599173,"Parent Artery Reconstruction for Large or Giant Cerebral Aneurysms Using the Tubridge Flow Diverter: A Multicenter, Randomized, Controlled Clinical Trial (PARAT).","BACKGROUND AND PURPOSE


Although flow diverters have been reported with favorable clinical and angiographic outcomes in various literatures, randomized trials determining their true effectiveness and safety are still in lack. The Parent Artery Reconstruction for Large or Giant Cerebral Aneurysms Using the Tubridge Flow Diverter (PARAT) trial was designed to evaluate the safety and efficacy of the Tubridge flow diverter in the treatment of large or giant aneurysms in comparison with Enterprise stent-assisted coiling.
MATERIALS AND METHODS


This prospective, multicenter, randomized trial was conducted at 12 hospitals throughout China. Enrolled adults with unruptured large/giant intracranial aneurysms were randomly assigned (1:1) to receive either Enterprise stent-assisted coiling or Tubridge flow diverter implantation. The primary end point was complete occlusion at 6-month follow-up, while secondary end points included technical success, mortality, target vessel-related stroke, aneurysm bleeding, in-stent stenosis, parent artery occlusion, and the frequency of all adverse events.
RESULTS


Among 185 enrolled subjects, 41 withdrew before procedure initiation. Overall, 82 subjects underwent Tubridge implantation, and 62 subjects were primarily treated with stent-assisted coiling. The results of 6-month follow-up imaging included complete occlusion rates of 75.34% versus 24.53% for the Tubridge and stent-assisted coiling groups, respectively, with a calculated common odds ratio of 9.4 (95% confidence interval, 4.14-21.38;  P  < .001). There was a higher, nonsignificant frequency of complications for Tubridge subjects. Multivariate analysis showed a decreased stroke rate at the primary investigational site, with a marginal  P  value ( P  = .051).
CONCLUSIONS


This trial showed an obviously higher rate of large and giant aneurysm obliteration with the Tubridge FD over Enterprise stent-assisted coiling. However, this higher obliteration rate came at the cost of a nonsignificantly higher rate of complications. Investigational site comparisons suggested that a learning curve for flow-diverter implantation should be recognized and factored into trial designs.",2018,This trial showed an obviously higher rate of large and giant aneurysm obliteration with the Tubridge FD over Enterprise stent-assisted coiling.,"['185 enrolled subjects, 41 withdrew before procedure initiation', '82 subjects underwent Tubridge implantation, and 62 subjects were primarily treated with', 'large or giant aneurysms in comparison with Enterprise stent-assisted coiling', 'Enrolled adults with unruptured large/giant intracranial aneurysms', '12 hospitals throughout China']","['Enterprise stent-assisted coiling or Tubridge flow diverter implantation', 'stent-assisted coiling']","['safety and efficacy', 'stroke rate', 'complete occlusion rates', 'complete occlusion', 'technical success, mortality, target vessel-related stroke, aneurysm bleeding, in-stent stenosis, parent artery occlusion, and the frequency of all adverse events', 'rate of large and giant aneurysm obliteration']","[{'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0585032', 'cui_str': 'Before procedure (qualifier value)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0017547', 'cui_str': 'Pituitary Gigantism'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751004', 'cui_str': 'Giant Intracranial Aneurysm'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C4049553', 'cui_str': 'Stent stenosis'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0017547', 'cui_str': 'Pituitary Gigantism'}, {'cui': 'C0332465', 'cui_str': 'Obliteration (morphologic abnormality)'}]",185.0,0.235268,This trial showed an obviously higher rate of large and giant aneurysm obliteration with the Tubridge FD over Enterprise stent-assisted coiling.,"[{'ForeName': 'J-M', 'Initials': 'JM', 'LastName': 'Liu', 'Affiliation': 'From the Department of Neurosurgery, (J.-m.L., Y.Z., P.-f.Y., B.H., Y.X., Q.L., R.Z., Y.F., K.Z., Q.H.), Shanghai Changhai Hospital, Shanghai, China liu118@vip.163.com.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'From the Department of Neurosurgery, (J.-m.L., Y.Z., P.-f.Y., B.H., Y.X., Q.L., R.Z., Y.F., K.Z., Q.H.), Shanghai Changhai Hospital, Shanghai, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Neurosurgery (Y.L., X.Y.), Tiantan Hospital, Beijing, China.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ""Department of Interventional Radiology (T.L., W.B.), Henan Provincial People's Hospital, Henan Province, China.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Leng', 'Affiliation': 'Department of Neurosurgery (B.L., Y.T.), Huashan Hospital, Shanghai, China.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurosurgery (P.Z., H.Z.), Xuanwu Hospital, Beijing, China.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Liang', 'Affiliation': 'Department of Neurosurgery (G.L., Z.L.), General Hospital of Shenyang Military, Shenyang Province, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'From the Department of Neurosurgery, (J.-m.L., Y.Z., P.-f.Y., B.H., Y.X., Q.L., R.Z., Y.F., K.Z., Q.H.), Shanghai Changhai Hospital, Shanghai, China.'}, {'ForeName': 'P-F', 'Initials': 'PF', 'LastName': 'Yang', 'Affiliation': 'From the Department of Neurosurgery, (J.-m.L., Y.Z., P.-f.Y., B.H., Y.X., Q.L., R.Z., Y.F., K.Z., Q.H.), Shanghai Changhai Hospital, Shanghai, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Department of Neurosurgery (H.S.), First Clinical Hospital affiliated with Harbin Medical University, Heilongjiang Province, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurosurgery (J.Z.), Second Affiliated Hospital of Zhejiang University, Hangzhou Municipality, Zhejiang, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wan', 'Affiliation': 'Department of Neurosurgery (J.W.), Renji Hospital, Shanghai, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Department of Neurosurgery (W.H.), Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Liang', 'Affiliation': 'Department of Neurosurgery (C.L.), First Hospital of China Medical University, Shenyang Municipality, Liaoning, China.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Zhu', 'Affiliation': 'Department of Neurosurgery (G.Z.), Southwest Hospital, Chongqing Municipality, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'From the Department of Neurosurgery, (J.-m.L., Y.Z., P.-f.Y., B.H., Y.X., Q.L., R.Z., Y.F., K.Z., Q.H.), Shanghai Changhai Hospital, Shanghai, China.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hong', 'Affiliation': 'From the Department of Neurosurgery, (J.-m.L., Y.Z., P.-f.Y., B.H., Y.X., Q.L., R.Z., Y.F., K.Z., Q.H.), Shanghai Changhai Hospital, Shanghai, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Neurosurgery (Y.L., X.Y.), Tiantan Hospital, Beijing, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Bai', 'Affiliation': ""Department of Interventional Radiology (T.L., W.B.), Henan Provincial People's Hospital, Henan Province, China.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Department of Neurosurgery (B.L., Y.T.), Huashan Hospital, Shanghai, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurosurgery (P.Z., H.Z.), Xuanwu Hospital, Beijing, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Neurosurgery (G.L., Z.L.), General Hospital of Shenyang Military, Shenyang Province, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'From the Department of Neurosurgery, (J.-m.L., Y.Z., P.-f.Y., B.H., Y.X., Q.L., R.Z., Y.F., K.Z., Q.H.), Shanghai Changhai Hospital, Shanghai, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Zhao', 'Affiliation': 'From the Department of Neurosurgery, (J.-m.L., Y.Z., P.-f.Y., B.H., Y.X., Q.L., R.Z., Y.F., K.Z., Q.H.), Shanghai Changhai Hospital, Shanghai, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': 'From the Department of Neurosurgery, (J.-m.L., Y.Z., P.-f.Y., B.H., Y.X., Q.L., R.Z., Y.F., K.Z., Q.H.), Shanghai Changhai Hospital, Shanghai, China.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Zhao', 'Affiliation': 'From the Department of Neurosurgery, (J.-m.L., Y.Z., P.-f.Y., B.H., Y.X., Q.L., R.Z., Y.F., K.Z., Q.H.), Shanghai Changhai Hospital, Shanghai, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AJNR. American journal of neuroradiology,['10.3174/ajnr.A5619']
758,31633158,Lopinavir-Ritonavir Impairs Adrenal Function in Infants.,"BACKGROUND


Perinatal treatment with lopinavir boosted by ritonavir (LPV/r) is associated with steroidogenic abnormalities. Long-term effects in infants have not been studied.
METHODS


Adrenal-hormone profiles were compared at weeks 6 and 26 between human immunodeficiency virus (HIV)-1-exposed but uninfected infants randomly assigned at 7 days of life to prophylaxis with LPV/r or lamivudine (3TC) to prevent transmission during breastfeeding. LPV/r in vitro effect on steroidogenesis was assessed in H295R cells.
RESULTS


At week 6, 159 frozen plasma samples from Burkina Faso and South Africa were assessed (LPV/r group: n = 92; 3TC group: n = 67) and at week 26, 95 samples from Burkina Faso (LPV/r group: n = 47; 3TC group: n = 48). At week 6, LPV/r-treated infants had a higher median dehydroepiandrosterone (DHEA) level than infants from the 3TC arm: 3.91 versus 1.48 ng/mL (P < .001). Higher DHEA levels (>5 ng/mL) at week 6 were associated with higher 17-OH-pregnenolone (7.78 vs 3.71 ng/mL, P = .0004) and lower testosterone (0.05 vs 1.34 ng/mL, P = .009) levels in LPV/r-exposed children. There was a significant correlation between the DHEA and LPV/r AUC levels (ρ = 0.40, P = .019) and Ctrough (ρ = 0.40, P = .017). At week 26, DHEA levels remained higher in the LPV/r arm: 0.45 versus 0.13 ng/mL (P = .002). Lopinavir, but not ritonavir, inhibited CYP17A1 and CYP21A2 activity in H295R cells.
CONCLUSIONS


Lopinavir was associated with dose-dependent adrenal dysfunction in infants. The impact of long-term exposure and potential clinical consequences require evaluation.
CLINICAL TRIALS REGISTRATION


NCT00640263.",2020,"Higher DHEA levels (>5 ng/mL) at week 6 were associated with higher 17-OH-pregnenolone (7.78 vs 3.71 ng/mL, P = .0004) and lower testosterone (0.05 vs 1.34 ng/mL, P = .009) levels in LPV/r-exposed children.","['Infants', 'Adrenal-hormone profiles were compared at weeks 6 and 26 between human immunodeficiency virus (HIV)-1-exposed but uninfected infants', 'infants']","['LPV/r or lamivudine (3TC', 'Lopinavir', 'lopinavir boosted by ritonavir (LPV/r', 'Lopinavir-Ritonavir']","['17-OH-pregnenolone', 'median dehydroepiandrosterone (DHEA) level', 'Higher DHEA levels', 'DHEA and LPV/r AUC levels', 'lower testosterone', 'DHEA levels']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1445654', 'cui_str': 'Adrenal hormone agent'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}]","[{'cui': 'C0373704', 'cui_str': 'Pregnenolone'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1295654', 'cui_str': 'Decreased testosterone level'}]",159.0,0.305568,"Higher DHEA levels (>5 ng/mL) at week 6 were associated with higher 17-OH-pregnenolone (7.78 vs 3.71 ng/mL, P = .0004) and lower testosterone (0.05 vs 1.34 ng/mL, P = .009) levels in LPV/r-exposed children.","[{'ForeName': 'Dulanjalee', 'Initials': 'D', 'LastName': 'Kariyawasam', 'Affiliation': 'Pediatric Endocrinology, Gynecology, and Diabetology Unit, Hopital Universitaire Necker-Enfants Malades, Assistance Publique-Hopitaux de Paris (AP-HP), Paris, France.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Peries', 'Affiliation': 'Pathogenesis and Control of Chronic Infections, INSERM U1058, Universite de Montpellier, Etablissement Francais du Sang, Montpellier, France.'}, {'ForeName': 'Frantz', 'Initials': 'F', 'LastName': 'Foissac', 'Affiliation': 'Service de Pharmacologie Clinique, Hopital Cochin, AP-HP, Groupe Hospitalier Paris Centre, France.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Eymard-Duvernay', 'Affiliation': 'Pathogenesis and Control of Chronic Infections, INSERM U1058, Universite de Montpellier, Etablissement Francais du Sang, Montpellier, France.'}, {'ForeName': 'Thorkild', 'Initials': 'T', 'LastName': 'Tylleskär', 'Affiliation': 'Centre for International Health, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Mandisa', 'Initials': 'M', 'LastName': 'Singata-Madliki', 'Affiliation': 'Effective Care Research Unit, University of Fort Hare, Cecilia Makiwane Hospital, East London, South Africa.'}, {'ForeName': 'Chipepo', 'Initials': 'C', 'LastName': 'Kankasa', 'Affiliation': 'University of Zambia, School of Medicine, Department of Pediatrics and Child Health, University Teaching Hospital, Lusaka, Zambia.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Meda', 'Affiliation': 'Center of International Research for Health, Faculty of Health Sciences, University of Ouagadougou, Ouagadougou, Burkina Faso.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tumwine', 'Affiliation': 'Department of Pediatrics and Child Health, School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Mwiya', 'Initials': 'M', 'LastName': 'Mwiya', 'Affiliation': 'University of Zambia, School of Medicine, Department of Pediatrics and Child Health, University Teaching Hospital, Lusaka, Zambia.'}, {'ForeName': 'Ingunn', 'Initials': 'I', 'LastName': 'Engebretsen', 'Affiliation': 'Centre for International Health, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Christa E', 'Initials': 'CE', 'LastName': 'Flück', 'Affiliation': 'Pediatric Endocrinology, Diabetology, and Metabolism, Department of Pediatrics and Department of BioMedical Research, University Hospital Inselspital Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Michaela F', 'Initials': 'MF', 'LastName': 'Hartmann', 'Affiliation': 'Steroid Research and Mass Spectrometry Unit, Division of Pediatric Endocrinology and Diabetology, Center of Child and Adolescent Medicine, Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'Stefan A', 'Initials': 'SA', 'LastName': 'Wudy', 'Affiliation': 'Steroid Research and Mass Spectrometry Unit, Division of Pediatric Endocrinology and Diabetology, Center of Child and Adolescent Medicine, Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Hirt', 'Affiliation': 'Service de Pharmacologie Clinique, Hopital Cochin, AP-HP, Groupe Hospitalier Paris Centre, France.'}, {'ForeName': 'Jean Marc', 'Initials': 'JM', 'LastName': 'Treluyer', 'Affiliation': 'Service de Pharmacologie Clinique, Hopital Cochin, AP-HP, Groupe Hospitalier Paris Centre, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Molès', 'Affiliation': 'Pathogenesis and Control of Chronic Infections, INSERM U1058, Universite de Montpellier, Etablissement Francais du Sang, Montpellier, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Blanche', 'Affiliation': 'Pediatric Immunology-Hematology and Rheumatology Unit, Hopital Universitaire Necker-Enfants Malades, AP-HP, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Van De Perre', 'Affiliation': 'Service de Pharmacologie Clinique, Hopital Cochin, AP-HP, Groupe Hospitalier Paris Centre, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Polak', 'Affiliation': 'Pediatric Endocrinology, Gynecology, and Diabetology Unit, Hopital Universitaire Necker-Enfants Malades, Assistance Publique-Hopitaux de Paris (AP-HP), Paris, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Nagot', 'Affiliation': 'Pathogenesis and Control of Chronic Infections, INSERM U1058, Universite de Montpellier, Etablissement Francais du Sang, Montpellier, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz888']
759,31620886,Daily intake of heat-killed Lactobacillus plantarum L-137 improves inflammation and lipid metabolism in overweight healthy adults: a randomized-controlled trial.,"PURPOSE


The effects of heat-killed Lactobacillus plantarum L-137 (HK L-137) on inflammation and lipid metabolism were investigated in overweight volunteers.
METHODS


One hundred healthy subjects with a body mass index from 23.0 to 29.9 (51 men and 49 women; mean age: 41.4 years) were enrolled in this randomized, double-blind, placebo-controlled, parallel group study. Subjects were randomly assigned to daily administration of a tablet containing HK L-137 (10 mg) or a placebo tablet for 12 weeks. Blood samples were collected every 4 weeks to measure biomarkers of lipid metabolism and inflammatory mediators.
RESULTS


The percent change of concanavalin A-induced proliferation of peripheral blood mononuclear cells was significantly larger in the HK L-137 group than in the control group, similar to previous studies. The decreases of aspartate aminotransferase and alanine aminotransferase over time were significantly larger in the HK L-137 group than in the control group, as were the decreases of total cholesterol, low-density lipoprotein cholesterol, and the leukocyte count at one time point. These effects of HK L-137 were stronger in the subjects with higher C-reactive protein levels.
CONCLUSIONS


These findings suggest that daily intake of HK L-137 can improve inflammation and lipid metabolism in subjects at risk of inflammation.",2020,"The decreases of aspartate aminotransferase and alanine aminotransferase over time were significantly larger in the HK L-137 group than in the control group, as were the decreases of total cholesterol, low-density lipoprotein cholesterol, and the leukocyte count at one time point.","['overweight volunteers', 'subjects at risk of inflammation', 'One hundred healthy subjects with a body mass index from 23.0 to 29.9 (51 men and 49 women; mean age: 41.4\xa0years', 'overweight healthy adults']","['heat-killed Lactobacillus plantarum L-137 (HK L-137', 'HK L-137', 'tablet containing HK L-137', 'placebo', 'placebo tablet', 'heat-killed Lactobacillus plantarum L-137']","['peripheral blood mononuclear cells', 'aspartate aminotransferase and alanine aminotransferase over time', 'inflammation and lipid metabolism', 'total cholesterol, low-density lipoprotein cholesterol, and the leukocyte count']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C4521763', 'cui_str': 'Killed'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}]",100.0,0.143037,"The decreases of aspartate aminotransferase and alanine aminotransferase over time were significantly larger in the HK L-137 group than in the control group, as were the decreases of total cholesterol, low-density lipoprotein cholesterol, and the leukocyte count at one time point.","[{'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Research Division, Research and Development Institute, House Wellness Foods Corp., Imoji 3-20, Itami, Hyogo, 664-0011, Japan. Tanaka_Yuusuke@house-wf.co.jp.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Hirose', 'Affiliation': 'Research Division, Research and Development Institute, House Wellness Foods Corp., Imoji 3-20, Itami, Hyogo, 664-0011, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Research Division, Research and Development Institute, House Wellness Foods Corp., Imoji 3-20, Itami, Hyogo, 664-0011, Japan.'}, {'ForeName': 'Yasunobu', 'Initials': 'Y', 'LastName': 'Yoshikai', 'Affiliation': 'Division of Host Defense, Medical Institute of Bioregulation, Kyushu University, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Murosaki', 'Affiliation': 'Research Division, Research and Development Institute, House Wellness Foods Corp., Imoji 3-20, Itami, Hyogo, 664-0011, Japan.'}]",European journal of nutrition,['10.1007/s00394-019-02112-3']
760,31558086,A pulse-based diet and the Therapeutic Lifestyle Changes diet in combination with health counseling and exercise improve health-related quality of life in women with polycystic ovary syndrome: secondary analysis of a randomized controlled trial.,"Objective:  A favorable dietary composition to increase health-related quality of life (HRQoL) in PCOS remains unclear. We compared changes in HRQoL of women with PCOS who participated in a low-glycemic-index pulse-based (lentils, beans, split peas, and chickpeas) or the Therapeutic Lifestyle Changes (TLC) diet intervention. Methods:  Thirty women in the pulse-based and 31 in the TLC groups (18-35 years) completed a 16-week intervention without energy-restriction. Groups participated in health counseling (monthly) and aerobic exercise (5 days/week; 45 minutes/day). Results:  Fifty-five (90.2%) women completed a PCOS-specific HRQoL survey. Greatest mean increases in time-effects occurred in the domains of healthy eating, PCOS knowledge, active living, healthcare satisfaction, feelings and experiences about intervention, and health concerns, respectively ( p  ≤ 0.02), without group-by-time interactions ( p  ≥ 0.13). Decreased weight ( r  = -0.35) and homeostatic model assessment of insulin resistance ( r  = -0.18) correlated with increased scores of PCOS knowledge; adherence to intervention correlated with increased scores of active living ( r  = 0.39) and healthy eating ( r  = 0.53;  p  ≤ 0.03). Conclusions:  Both interventions improved HRQoL scores in women with PCOS without prescribed energy-restriction. Our observations add novel insights into current evidence and elucidate the need for future psychological research to target lifestyle modifications for improving HRQoL and unique psychological complications of PCOS in this high-risk population (CinicalTrials.gov identifier:NCT01288638).",2020,"Greatest mean increases in time-effects occurred in the domains of healthy eating, PCOS knowledge, active living, healthcare satisfaction, feelings and experiences about intervention, and health concerns, respectively ( p  ≤ 0.02), without group-by-time interactions ( p  ≥ 0.13).","['women with polycystic ovary syndrome', 'women with PCOS who participated in a low-glycemic-index pulse-based (lentils, beans, split peas, and chickpeas) or the Therapeutic Lifestyle Changes (TLC) diet intervention', 'women with PCOS without prescribed energy-restriction', 'Thirty women in the pulse-based and 31 in the TLC groups (18-35 years) completed a']","['pulse-based diet and the Therapeutic Lifestyle Changes diet in combination with health counseling and exercise', '16-week intervention without energy-restriction', 'health counseling (monthly) and aerobic exercise']","['Decreased weight', 'healthy eating, PCOS knowledge, active living, healthcare satisfaction, feelings and experiences about intervention, and health concerns', 'health-related quality of life (HRQoL', 'health-related quality of life', 'scores of active living', 'scores of PCOS knowledge; adherence', 'healthy eating', 'time-effects', 'HRQoL scores', 'homeostatic model assessment of insulin resistance']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023323', 'cui_str': 'Lentils'}, {'cui': 'C0004896', 'cui_str': 'Bean (substance)'}, {'cui': 'C0030738', 'cui_str': 'Peas'}, {'cui': 'C0950052', 'cui_str': 'Chickpea'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0040509', 'cui_str': 'Total Lung Capacity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}]",30.0,0.103133,"Greatest mean increases in time-effects occurred in the domains of healthy eating, PCOS knowledge, active living, healthcare satisfaction, feelings and experiences about intervention, and health concerns, respectively ( p  ≤ 0.02), without group-by-time interactions ( p  ≥ 0.13).","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kazemi', 'Affiliation': 'Division of Nutrition and Dietetics, College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'McBreairty', 'Affiliation': 'Division of Nutrition and Dietetics, College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'Gordon A', 'Initials': 'GA', 'LastName': 'Zello', 'Affiliation': 'Division of Nutrition and Dietetics, College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Pierson', 'Affiliation': 'Obstetrics and Gynecology, College of Medicine, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'Julianne J', 'Initials': 'JJ', 'LastName': 'Gordon', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'Shani B', 'Initials': 'SB', 'LastName': 'Serrao', 'Affiliation': 'Obstetrics and Gynecology, College of Medicine, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Chilibeck', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'Donna R', 'Initials': 'DR', 'LastName': 'Chizen', 'Affiliation': 'Obstetrics and Gynecology, College of Medicine, University of Saskatchewan, Saskatoon, Canada.'}]",Journal of psychosomatic obstetrics and gynaecology,['10.1080/0167482X.2019.1666820']
761,30191265,Cardiac rehabilitation therapy for coronary slow flow phenomenon.,"OBJECTIVE


To evaluate the effectiveness of cardiac rehabilitation on coronary slow flow phenomenon.
METHOD


Included were 30 consecutive patients from June 2015 to June 2017. A thrombolysis in myocardial infarction (TIMI) frame evaluation was used to estimate coronary blood flow velocity. All coronary angiography diameters were normal, but blood flow levels did not reach the TIMI level 3. All patients were treated with aspirin and rosuvastatin. Patients were randomly assigned to an experimental group (cardiac rehabilitation treatment group, n = 15) or a control group (normal treatment without cardiac rehabilitation, n = 15). Plasma low density lipoprotein cholesterol (LDL-C), triglyceride (TG), high-sensitivity C reactive protein (hs-CRP), homocysteine (Hcy) and arginine (Arg) expression levels were collected after admission. These indices were reviewed again after 20-30 weeks, improved subjective symptoms were evaluated by multiple outcome criteria (MOCs), and coronary angiography was used to evaluate the velocity of coronary artery blood flow.
RESULT


The expression levels of LDL-C and TG in the experimental group were significantly lower than those of the control group (both P < 0.01). The plasma levels of hs-CRP, Hcy and Arg were lower than those in the control group (all P < 0.01). In the experimental group, subjective symptoms of chest pain were significantly improved and the coronary artery blood flow velocity was significantly increased compared with the control group (P < 0.01).
CONCLUSION


Cardiac rehabilitation can reduce the plasma levels of LDL-C, TG, hs-CRP, Hcy and Arg, significantly improve the symptoms of coronary slow flow phenomenon and accelerate the speed of coronary artery blood flow.",2020,"The plasma levels of hs-CRP, Hcy and Arg were lower than those in the control group (all P < 0.01).",['Included were 30\xa0consecutive patients from June 2015 to June 2017'],"['Cardiac rehabilitation', 'cardiac rehabilitation', 'Cardiac rehabilitation therapy', 'experimental group (cardiac rehabilitation treatment group, n\u202f=\u200915) or a\xa0control group (normal treatment without cardiac rehabilitation, n\u202f=\u200915', 'aspirin and rosuvastatin']","['plasma levels of hs-CRP, Hcy and Arg', 'speed of coronary artery blood flow', 'Plasma low density lipoprotein cholesterol (LDL-C), triglyceride (TG), high-sensitivity C\xa0reactive protein (hs-CRP), homocysteine (Hcy) and arginine (Arg) expression levels', 'expression levels of LDL-C and TG', 'coronary artery blood flow velocity', 'subjective symptoms of chest pain', 'velocity of coronary artery blood flow', 'plasma levels of LDL-C, TG, hs-CRP, Hcy and Arg', 'coronary blood flow velocity', 'blood flow levels', 'subjective symptoms']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0019878', 'cui_str': '2-amino-4-mercaptobutyric acid'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}]",,0.0133583,"The plasma levels of hs-CRP, Hcy and Arg were lower than those in the control group (all P < 0.01).","[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'She', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, Hubei, China. whuwangzhuo@163.com.'}]",Herz,['10.1007/s00059-018-4742-y']
762,30032464,Smartphone-based delivery of oropharyngeal exercises for treatment of snoring: a randomized controlled trial.,"PURPOSE


Upper airway exercises for snoring treatment can be effective but difficult to administer and monitor. We hypothesized that a brief, relatively simple daily upper airway exercise regimen, administered by a smartphone application, would reduce snoring and encourage compliance.
METHODS


Targeted vowel sounds causing tongue base movements were incorporated into a voice-controlled smartphone game application. Participants with habitual snoring, apnea hypopnea index (AHI) ≤ 14 events/h, and BMI ≤ 32 kg/m 2  were randomly assigned to perform 15 min of daily gameplay (intervention group) or 5 s of daily voice recording (control group) and to audio record their snoring for 2 nights/week for up to 12 weeks. Sounds above 60 dB were extracted from recordings for snore classification with machine learning support vector machine classifiers.
RESULTS


Sixteen patients (eight in each group) completed the protocol. Groups were similar at baseline in gender distribution (five males, three females), mean BMI (27.5 ± 3.8 vs 27.4 ± 3.8 kg/m 2 ), neck circumference (15.1 ± 1.6 vs 14.7 ± 1.7 in.), Epworth Sleepiness Score (8 ± 3.5 vs 7 ± 4.0), and AHI (9.2 ± 4.0 vs 8.2 ± 3.2 events/h). At 8 weeks, the absolute change in snoring rate (> 60 dB/h) was greater for the intervention group than the control group (- 49.3 ± 55.3 vs - 6.23 ± 23.2; p = 0.037), a 22 and 5.6% reduction, respectively. All bed partners of participants in the intervention group reported reduced snoring volume and frequency, whereas no change was reported for the control group.
CONCLUSIONS


Smartphone application-administered upper airway training reduces objective and subjective snoring measures and improves sleep quality.
TRIAL REGISTRATION


ClinicalTrials.gov ; no.: NCT03264963; URL: www.clinicaltrials.gov.",2019,"At 8 weeks, the absolute change in snoring rate (> 60 dB/h) was greater for the intervention group than the control group (- 49.3 ± 55.3 vs - 6.23 ± 23.2; p = 0.037), a 22 and 5.6% reduction, respectively.","['Participants with habitual snoring, apnea hypopnea index (AHI)\u2009≤\u200914\xa0events/h, and BMI\u2009≤\u200932\xa0kg/m 2', 'snoring', 'Groups were similar at baseline in gender distribution (five males, three females), mean BMI (27.5\u2009±\u20093.8 vs 27.4\u2009±\u20093.8\xa0kg/m 2 ), neck circumference (15.1\u2009±\u20091.6 vs 14.7\u2009±']","['perform 15\xa0min of daily gameplay (intervention group) or 5\xa0s of daily voice recording (control group) and to audio record their snoring', 'Smartphone-based delivery of oropharyngeal exercises', 'Smartphone application-administered upper airway training']","[' Epworth Sleepiness Score', 'reduced snoring volume and frequency', 'sleep quality', 'objective and subjective snoring measures', 'absolute change in snoring rate']","[{'cui': 'C4510110', 'cui_str': 'Habitual snoring (finding)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0037384', 'cui_str': 'Snorings'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C1630403', 'cui_str': 'Neck circumference'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}]","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0037384', 'cui_str': 'Snorings'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037384', 'cui_str': 'Snorings'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0439565,"At 8 weeks, the absolute change in snoring rate (> 60 dB/h) was greater for the intervention group than the control group (- 49.3 ± 55.3 vs - 6.23 ± 23.2; p = 0.037), a 22 and 5.6% reduction, respectively.","[{'ForeName': 'Umesh', 'Initials': 'U', 'LastName': 'Goswami', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, University of Minnesota, 420 Delaware St. S.E, MMC 276, Minneapolis, MN, 55455, USA. goswa009@umn.edu.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Black', 'Affiliation': 'Medical Devices Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Krohn', 'Affiliation': 'Medical Devices Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Meyers', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, University of Minnesota, 420 Delaware St. S.E, MMC 276, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Conrad', 'Initials': 'C', 'LastName': 'Iber', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, University of Minnesota, 420 Delaware St. S.E, MMC 276, Minneapolis, MN, 55455, USA.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-018-1690-y']
763,31642984,The lipid-lowering effect of once-daily soya drink fortified with phytosterols in normocholesterolaemic Chinese: a double-blind randomized controlled trial.,"PURPOSE


Phytosterols reduce intestinal cholesterol absorption and help to lower LDL-cholesterol. Many Chinese adults are lactose-intolerant and cannot tolerate bovine milk enriched with phytosterol. Soya-milk is a common beverage in Asia and it has beneficial effects on general health. We therefore conducted a randomized double-blind controlled trial to assess the effectiveness of a phytosterols-enriched soya drink in lowering serum LDL-cholesterol level (primary outcome) and other cardiovascular parameters (secondary outcomes).
METHODS


One hundred and fifty-nine normocholesterolaemic participants (85 men and 74 women; aged 19-79) were randomized to daily intake of one serving of phytosterols-enriched soya drink (N = 82), equivalent to 2 g of phytosterol per day, or a matched soya drink without phytosterols (N = 77) for 3 weeks. Adverse events, withdrawal and compliance were documented.
RESULTS


Among the treatment group (N = 82), phytosterols-enriched soya drink significantly decreased LDL-cholesterol by 5.96% (SE 1.48, 95% CI - 8.91%, - 3.00%) with a median of 6.74% compared with baseline, resulting in a significant reduction of 4.70% (95% CI - 8.89%, - 0.51%; p = 0.028) with a median of 5.20% compared with placebo (N = 77). In contrast, there were no significant changes in other lipid parameters, blood glucose, blood pressure, body weight or waist circumference. Remarkably, 95% of the participants randomized to the fortified drink reported no adverse events at all.
CONCLUSIONS


Daily consumption of a phytosterols-enriched soya drink may be a simple and cost-neutral means of lowering LDL-cholesterol in individuals in China, with massive population and rising incidence of coronary heart disease (ClinicalTrials.gov identifier: NCT02881658; date of registration: 14 Aug 2016).",2020,"In contrast, there were no significant changes in other lipid parameters, blood glucose, blood pressure, body weight or waist circumference.","['normocholesterolaemic Chinese', 'One hundred and fifty-nine normocholesterolaemic participants (85 men and 74 women; aged 19-79']","['placebo', 'phytosterols-enriched soya drink', 'fortified drink', 'daily intake of one serving of phytosterols-enriched soya drink (N\u2009=\u200982), equivalent to 2\xa0g of phytosterol per day, or a matched soya drink without phytosterols']","['LDL-cholesterol', 'adverse events', 'Adverse events, withdrawal and compliance', 'lipid parameters, blood glucose, blood pressure, body weight or waist circumference', 'serum LDL-cholesterol level']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0031866', 'cui_str': 'Phytosterols'}, {'cui': 'C0037733', 'cui_str': 'Soy Beans'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0428474', 'cui_str': 'Serum LDL cholesterol measurement'}]",85.0,0.701151,"In contrast, there were no significant changes in other lipid parameters, blood glucose, blood pressure, body weight or waist circumference.","[{'ForeName': 'Yin-Pan', 'Initials': 'YP', 'LastName': 'Chau', 'Affiliation': 'Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Yu-Chun', 'Initials': 'YC', 'LastName': 'Cheng', 'Affiliation': 'Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Chor-Wing', 'Initials': 'CW', 'LastName': 'Sing', 'Affiliation': 'Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Man-Fung', 'Initials': 'MF', 'LastName': 'Tsoi', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Queen Mary Hospital, The University of Hong Kong, 102 Pokfulam Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Vincent Ka-Fai', 'Initials': 'VK', 'LastName': 'Cheng', 'Affiliation': 'Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Grace Koon-Yee', 'Initials': 'GK', 'LastName': 'Lee', 'Affiliation': 'Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Ching-Lung', 'Initials': 'CL', 'LastName': 'Cheung', 'Affiliation': 'Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Sassoon Road, Pokfulam, Hong Kong. lung1212@hku.hk.'}, {'ForeName': 'Bernard M Y', 'Initials': 'BMY', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Queen Mary Hospital, The University of Hong Kong, 102 Pokfulam Road, Pokfulam, Hong Kong. mycheung@hku.hk.'}]",European journal of nutrition,['10.1007/s00394-019-02119-w']
764,31635477,Effects of Heart Rate Variability Biofeedback in Patients With Acute Ischemic Stroke: A Randomized Controlled Trial.,"BACKGROUND


Autonomic dysfunction, cognitive impairment, and psychological distress are associated with poorer prognosis in patients with acute ischemic stroke (AIS). Heart rate variability (HRV) biofeedback (BF) improves autonomic dysfunction, cognitive impairment, and psychological distress in other patient populations, but its effect in patients with AIS is still unclear.
OBJECTIVE


This study investigated the effects of an HRVBF intervention on autonomic function, cognitive impairment, and psychological distress in patients with AIS.
METHOD


In this randomized, controlled, single-blind trial, patients with AIS were randomly assigned to the experimental or control group. The experimental group received four HRVBF training sessions. The control group received usual care. Repeated measures of HRV, mini-mental status examination (MMSE), and Hospital Anxiety and Depression Scales (HADS) were collected prior to and at 1 and 3 months postintervention.
RESULTS


A total of 35 patients completed the study (19 experimental, 16 control). HRV and HADS significantly improved in the experimental group ( p  < .001) but not in the control group. Likewise, only the experimental group showed significant improvements in HRV, MMSE, and HADS over time ( p  < .05).
CONCLUSION


HRVBF is a promising intervention for improving autonomic function, cognitive impairment, and psychological distress in patients with AIS. More studies of HRVBF interventions are needed to further optimize the effects of HRVBF on autonomic, cognitive, and psychological function in patients with AIS.",2020,HRV and HADS significantly improved in the experimental group ( p  < .001) but not in the control group.,"['35 patients completed the study (19 experimental, 16 control', 'patients with acute ischemic stroke (AIS', 'Patients With Acute Ischemic Stroke', 'patients with AIS']","['HRVBF training sessions', 'HRVBF', 'Heart Rate Variability Biofeedback', 'HRVBF intervention', 'usual care']","['HRV and HADS', 'HRV, MMSE, and HADS over time', 'Heart rate variability (HRV) biofeedback (BF) improves autonomic dysfunction, cognitive impairment, and psychological distress', 'autonomic, cognitive, and psychological function', 'HRV, mini-mental status examination (MMSE), and Hospital Anxiety and Depression Scales (HADS', 'autonomic function, cognitive impairment, and psychological distress']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}]","[{'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1145628', 'cui_str': 'Central Autonomic Nervous System Diseases'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0233398', 'cui_str': 'Psychological function'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0507452,HRV and HADS significantly improved in the experimental group ( p  < .001) but not in the control group.,"[{'ForeName': 'Wan-Ling', 'Initials': 'WL', 'LastName': 'Chang', 'Affiliation': 'Department of Nursing, Fu Jen Catholic University Hospital, New Taipei City.'}, {'ForeName': 'Jiunn-Tay', 'Initials': 'JT', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Tri-Service General Hospital, National Defense Medical Center, Taipei.'}, {'ForeName': 'Chi-Rong', 'Initials': 'CR', 'LastName': 'Li', 'Affiliation': 'Department of Teaching and Research, Taichung Hospital, Ministry of Health and Welfare, Taichung.'}, {'ForeName': 'Amy H T', 'Initials': 'AHT', 'LastName': 'Davis', 'Affiliation': 'College of Health and Society, Hawaii Pacific University, Kaneohe, HI, USA.'}, {'ForeName': 'Chia-Chen', 'Initials': 'CC', 'LastName': 'Yang', 'Affiliation': 'School of Nursing, National Defense Medical Center, Taipei.'}, {'ForeName': 'Yu-Ju', 'Initials': 'YJ', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, National Defense Medical Center, Taipei.'}]",Biological research for nursing,['10.1177/1099800419881210']
765,29402561,The single mandibular implant study - Short-term effects of the loading protocol on Oral Health-related Quality of Life.,"PURPOSE


A single implant can be placed to retain an overdenture in the edentulous mandible. This study aimed at the development of Oral Health-related Quality of Life comparing immediate and delayed implant loading, i.e., loading after 3 months of submerged healing.
METHODS


In a randomized controlled trial, 158 participants received a single mandibular implant in the midline. Quality of life was measured using the summary score of the German 49-item Oral Health Impact Profile at baseline, one month after implant placement (direct loading group) as well as one and four months after loading.
RESULTS


Mean scores at baseline were comparable. Four months after implantation, a decrease of mean scores was recognized for both groups, indicating a significantly enhanced quality of life after treatment. When comparing the groups after both 1 and 4 months of loading, quality of life was insignificantly higher in the delayed loading group (1 month: 42.1 vs. 32.3; 4 months: 33.6 vs. 27.7). For immediate loading, an insignificant tendency to an earlier improvement was recognized (Δ 1month-baseline : 9.7, compared to Δ 1month-baseline : 6.4).
CONCLUSIONS


The single mandibular implant concept was associated with a positive impact on quality of life. However, no statistically significant influence of implant loading on quality of life was found.",2018,"Four months after implantation, a decrease of mean scores was recognized for both groups, indicating a significantly enhanced quality of life after treatment.",['158 participants received a single mandibular implant in the midline'],[],"['Oral Health-related Quality of Life', 'Quality of life', 'Mean scores', 'quality of life', 'mean scores']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",[],"[{'cui': 'C0029162'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",158.0,0.056727,"Four months after implantation, a decrease of mean scores was recognized for both groups, indicating a significantly enhanced quality of life after treatment.","[{'ForeName': 'Franz Sebastian', 'Initials': 'FS', 'LastName': 'Schwindling', 'Affiliation': 'Department of Prosthetic Dentistry, University Hospital Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Raedel', 'Affiliation': 'Department of Prosthetic Dentistry, Faculty of Medicine Carl Gustav Carus, TU Dresden, Dresden, Germany. Electronic address: Michael.Raedel@uniklinikum-dresden.de.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Passia', 'Affiliation': 'Department of Prosthodontics, Propaedeutics and Dental Materials, School of Dentistry, Christian-Albrechts University, Kiel, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Freitag-Wolf', 'Affiliation': 'Institute for Medical Informatics and Statistics, Christian-Albrechts University, Kiel, Germany; Center for Clinical Studies, Christian-Albrechts University of Kiel, Kiel, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wolfart', 'Affiliation': 'Department of Prosthodontics and Biomaterials, University Hospital Aachen, Aachen, Germany.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Att', 'Affiliation': 'Department of Prosthetic Dentistry, School of Dentistry, University of Freiburg, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Mundt', 'Affiliation': 'Department of Prosthodontics, Gerodontology and Biomaterials, Greifswald University Hospital, Greifswald, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Reissmann', 'Affiliation': 'Department of Prosthodontics, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Fadi', 'Initials': 'F', 'LastName': 'Ismail', 'Affiliation': 'Department of Prosthodontics, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'von Königsmark', 'Affiliation': 'Department of Prosthodontics, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Kern', 'Affiliation': 'Department of Prosthodontics, Propaedeutics and Dental Materials, School of Dentistry, Christian-Albrechts University, Kiel, Germany.'}]",Journal of prosthodontic research,['10.1016/j.jpor.2017.12.003']
766,29369834,Oral Hypertonic Saline Is Effective in Reversing Acute Mild-to-Moderate Symptomatic Exercise -Associated Hyponatremia.,"OBJECTIVES


To determine whether oral administration of 3% hypertonic saline (HTS) is as efficacious as intravenous (IV) 3% saline in reversing symptoms of mild-to-moderate symptomatic exercise-associated hyponatremia (EAH) in athletes during and after a long-distance triathlon.
DESIGN


Noninferiority, open-label, parallel-group, randomized control trial to IV or oral HTS. We used permuted block randomization with sealed envelopes, containing the word either ""oral"" or ""IV.""
SETTING


Annual long-distance triathlon (3.8-km swim, 180-km bike, and 42-km run) at Mont-Tremblant, Quebec, Canada.
PARTICIPANTS


Twenty race finishers with mild to moderately symptomatic EAH.
INDEPENDENT VARIABLES


Age, sex, race finish time, and 9 clinical symptoms.
MAIN OUTCOME MEASURES


Time from treatment to discharge.
METHODS


We successfully randomized 20 participants to receive either an oral (n = 11) or IV (n = 9) bolus of HTS. We performed venipuncture to measure serum sodium (Na) at presentation to the medical clinic and at time of symptom resolution after the intervention.
RESULTS


The average time from treatment to discharge was 75.8 minutes (SD 29.7) for the IV treatment group and 50.3 minutes (SD 26.8) for the oral treatment group (t test, P = 0.02). Serum Na before and after treatment was not significantly different in both groups. There was no difference on presentation between groups in age, sex, or race finish time, both groups presented with an average of 6 symptoms.
CONCLUSIONS


Oral HTS is effective in reversing symptoms of mild-to-moderate hyponatremia in EAH.",2018,"There was no difference on presentation between groups in age, sex, or race finish time, both groups presented with an average of 6 symptoms.
","['Twenty race finishers with mild to moderately symptomatic EAH', 'Annual long-distance triathlon (3.8-km swim, 180-km bike, and 42-km run) at Mont-Tremblant, Quebec, Canada']","['Oral Hypertonic Saline', 'oral HTS', 'HTS', 'sealed envelopes, containing the word either ""oral"" or ""IV', '3% hypertonic saline (HTS']",['average time'],"[{'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}]",20.0,0.145485,"There was no difference on presentation between groups in age, sex, or race finish time, both groups presented with an average of 6 symptoms.
","[{'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Bridges', 'Affiliation': 'Department of Emergency Medicine, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Tawfeeq', 'Initials': 'T', 'LastName': 'Altherwi', 'Affiliation': 'EM FRCP Program-McGill University, Montreal, QC, Canada.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Correa', 'Affiliation': 'Department of Mathematics and Statistics, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Hew-Butler', 'Affiliation': 'Oakland University, Rochester, Michigan.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000573']
767,31466703,Optimized protein intakes in term infants support physiological growth and promote long-term health.,"Breastfeeding is associated with a reduced later obesity risk, relative to feeding convention infant formula. Breastfeeding induces less weight gain during the first two years of life, which predicts less obesity up to adulthood. We tested the hypothesis that a high infant protein supply promotes weight gain and obesity risk, mediated by increased plasma amino acids and growth factors, insulin and insulin like growth factor 1 (IGF-1). A large multi-centre double blind trial randomized formula-fed infants to conventional bottle milk with a high protein content, or an intervention formula with a reduced protein content more similar to levels provided with human milk. Protein-reduced formula normalized weight, body mass index and body fatness up to 6 years, relative to a breastfed reference group, and reduced the adjusted odds for obesity 2.6-fold. Available data indicate potential underlying mechanisms. We conclude that infant feeding has very marked long-term programming effects on later BMI, obesity and adiposity, with major public health implications. Breastfeeding lowers the risk for later obesity and adiposity. This provides additional motivation for proactively and enthusiastically promoting, protecting and supporting breastfeeding. A high milk protein intake in infancy increases the long-term risk for obesity and adiposity. Infants not or not fully breastfed should receive infant formula delivering protein in amounts more similar to human milk contents, with high protein quality. Other sources of very high infant protein intakes, particular drinking unmodified cows' milk, should be avoided in infancy.",2019,"Protein reduced formula normalized weight, body mass index and body fatness up to 6 years, relative to a breastfed reference group, and reduced the adjusted odds for obesity 2,6fold.",[],['conventional bottle milk'],"['formula normalized weight, body mass index and body fatness', 'later BMI, obesity and adiposity', 'plasma amino acids and growth factors, insulin and insulin like growth factor 1 (IGF-1', 'weight gain']",[],"[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C4319838', 'cui_str': 'Bottle'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",,0.0197722,"Protein reduced formula normalized weight, body mass index and body fatness up to 6 years, relative to a breastfed reference group, and reduced the adjusted odds for obesity 2,6fold.","[{'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Koletzko', 'Affiliation': ""Div. Metabolic and Nutritional Medicine, Dept. of Pediatrics, Dr. von Hauner Children's Hospital, University Hospital, LMU - Ludwig-Maximilians-Universität Munich, Lindwurmstr. 4, D-80337 München, Germany. Electronic address: office.koletzko@med.lmu.de.""}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Demmelmair', 'Affiliation': ""Div. Metabolic and Nutritional Medicine, Dept. of Pediatrics, Dr. von Hauner Children's Hospital, University Hospital, LMU - Ludwig-Maximilians-Universität Munich, Lindwurmstr. 4, D-80337 München, Germany.""}, {'ForeName': 'Veit', 'Initials': 'V', 'LastName': 'Grote', 'Affiliation': ""Div. Metabolic and Nutritional Medicine, Dept. of Pediatrics, Dr. von Hauner Children's Hospital, University Hospital, LMU - Ludwig-Maximilians-Universität Munich, Lindwurmstr. 4, D-80337 München, Germany.""}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Totzauer', 'Affiliation': ""Div. Metabolic and Nutritional Medicine, Dept. of Pediatrics, Dr. von Hauner Children's Hospital, University Hospital, LMU - Ludwig-Maximilians-Universität Munich, Lindwurmstr. 4, D-80337 München, Germany.""}]",Seminars in perinatology,['10.1053/j.semperi.2019.06.001']
768,31488369,A community-based comprehensive intervention to reduce cardiovascular risk in hypertension (HOPE 4): a cluster-randomised controlled trial.,"BACKGROUND


Hypertension is the leading cause of cardiovascular disease globally. Despite proven benefits, hypertension control is poor. We hypothesised that a comprehensive approach to lowering blood pressure and other risk factors, informed by detailed analysis of local barriers, would be superior to usual care in individuals with poorly controlled or newly diagnosed hypertension. We tested whether a model of care involving non-physician health workers (NPHWs), primary care physicians, family, and the provision of effective medications, could substantially reduce cardiovascular disease risk.
METHODS


HOPE 4 was an open, community-based, cluster-randomised controlled trial involving 1371 individuals with new or poorly controlled hypertension from 30 communities (defined as townships) in Colombia and Malaysia. 16 communities were randomly assigned to control (usual care, n=727), and 14 (n=644) to the intervention. After community screening, the intervention included treatment of cardiovascular disease risk factors by NPHWs using tablet computer-based simplified management algorithms and counselling programmes; free antihypertensive and statin medications recommended by NPHWs but supervised by physicians; and support from a family member or friend (treatment supporter) to improve adherence to medications and healthy behaviours. The primary outcome was the change in Framingham Risk Score 10-year cardiovascular disease risk estimate at 12 months between intervention and control participants. The HOPE 4 trial is registered at ClinicalTrials.gov, NCT01826019.
FINDINGS


All communities completed 12-month follow-up (data on 97% of living participants, n=1299). The reduction in Framingham Risk Score for 10-year cardiovascular disease risk was -6·40% (95% CI 8·00 to -4·80) in the control group and -11·17% (-12·88 to -9·47) in the intervention group, with a difference of change of -4·78% (95% CI -7·11 to -2·44, p<0·0001). There was an absolute 11·45 mm Hg (95% CI -14·94 to -7·97) greater reduction in systolic blood pressure, and a 0·41 mmol/L (95% CI -0·60 to -0·23) reduction in LDL with the intervention group (both p<0·0001). Change in blood pressure control status (<140 mm Hg) was 69% in the intervention group versus 30% in the control group (p<0·0001). There were no safety concerns with the intervention.
INTERPRETATION


A comprehensive model of care led by NPHWs, involving primary care physicians and family that was informed by local context, substantially improved blood pressure control and cardiovascular disease risk. This strategy is effective, pragmatic, and has the potential to substantially reduce cardiovascular disease compared with current strategies that are typically physician based.
FUNDING


Canadian Institutes of Health Research; Grand Challenges Canada; Ontario SPOR Support Unit and the Ontario Ministry of Health and Long-Term Care; Boehringer Ingelheim; Department of Management of Non-Communicable Diseases, WHO; and Population Health Research Institute. VIDEO ABSTRACT.",2019,Change in blood pressure control status (<140 mm Hg) was 69% in the intervention group versus 30% in the control group (p<0·0001).,"['individuals with poorly controlled or newly diagnosed hypertension', '1371 individuals with new or poorly controlled hypertension from 30 communities (defined as townships) in Colombia and Malaysia', '16 communities']","['NPHWs using tablet computer-based simplified management algorithms and counselling programmes; free antihypertensive and statin medications recommended by NPHWs but supervised by physicians; and support from a family member or friend (treatment supporter', 'community-based comprehensive intervention']","['Framingham Risk Score for 10-year cardiovascular disease risk', 'blood pressure control and cardiovascular disease risk', 'blood pressure control status', 'cardiovascular risk', 'change in Framingham Risk Score 10-year cardiovascular disease risk estimate', 'systolic blood pressure']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}]","[{'cui': 'C4045980', 'cui_str': 'Tablet Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002045'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0079382', 'cui_str': 'Friend (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",1371.0,0.100574,Change in blood pressure control status (<140 mm Hg) was 69% in the intervention group versus 30% in the control group (p<0·0001).,"[{'ForeName': 'Jon-David', 'Initials': 'JD', 'LastName': 'Schwalm', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada. Electronic address: schwalj@mcmaster.ca.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'McCready', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Lopez-Jaramillo', 'Affiliation': 'Research Institute, Fundación Oftalmológica de Santander, Floridablanca, Colombia; Masira Institute, Medical School, Universidad de Santander, Bucaramanga, Colombia.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Yusoff', 'Affiliation': 'Faculty of Medicine, Universiti Teknologi MARA, Selayang, Selangor, Malaysia; Faculty of Medicine and Health Sciences, UCSI, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Attaran', 'Affiliation': 'Faculty of Law, University of Ottawa, Ottawa, ON, Canada; Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Lamelas', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Camacho', 'Affiliation': 'Research Institute, Fundación Oftalmológica de Santander, Floridablanca, Colombia; Medical School, Universidad Autónoma de Bucaramanga, Bucaramanga, Colombia.'}, {'ForeName': 'Fadhlina', 'Initials': 'F', 'LastName': 'Majid', 'Affiliation': 'Faculty of Medicine, Universiti Teknologi MARA, Selayang, Selangor, Malaysia.'}, {'ForeName': 'Shrikant I', 'Initials': 'SI', 'LastName': 'Bangdiwala', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada; Department of Health Research Methods, Evidence and Impact, McMaster University Faculty of Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University Faculty of Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Shofiqul', 'Initials': 'S', 'LastName': 'Islam', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'McKee', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada; Department of Health Research Methods, Evidence and Impact, McMaster University Faculty of Health Sciences, Hamilton, ON, Canada.'}]","Lancet (London, England)",['10.1016/S0140-6736(19)31949-X']
769,29236628,Outcomes of a Coaching-Based WHO Safe Childbirth Checklist Program in India.,"BACKGROUND


The prevalence of facility-based childbirth in low-resource settings has increased dramatically during the past two decades, yet gaps in the quality of care persist and mortality remains high. The World Health Organization (WHO) Safe Childbirth Checklist, a quality-improvement tool, promotes systematic adherence to practices that have been associated with improved childbirth outcomes.
METHODS


We conducted a matched-pair, cluster-randomized, controlled trial in 60 pairs of facilities across 24 districts of Uttar Pradesh, India, testing the effect of the BetterBirth program, an 8-month coaching-based implementation of the Safe Childbirth Checklist, on a composite outcome of perinatal death, maternal death, or maternal severe complications within 7 days after delivery. Outcomes - assessed 8 to 42 days after delivery - were compared between the intervention group and the control group with adjustment for clustering and matching. We also compared birth attendants' adherence to 18 essential birth practices in 15 matched pairs of facilities at 2 and 12 months after the initiation of the intervention.
RESULTS


Of 161,107 eligible women, we enrolled 157,689 (97.9%) and determined 7-day outcomes for 157,145 (99.7%) mother-newborn dyads. Among 4888 observed births, birth attendants' mean practice adherence was significantly higher in the intervention group than in the control group (72.8% vs. 41.7% at 2 months; 61.7% vs. 43.9% at 12 months; P<0.001 for both comparisons). However, there was no significant difference between the trial groups either in the composite primary outcome (15.1% in the intervention group and 15.3% in the control group; relative risk, 0.99; 95% confidence interval, 0.83 to 1.18; P=0.90) or in secondary maternal or perinatal adverse outcomes.
CONCLUSIONS


Birth attendants' adherence to essential birth practices was higher in facilities that used the coaching-based WHO Safe Childbirth Checklist program than in those that did not, but maternal and perinatal mortality and maternal morbidity did not differ significantly between the two groups. (Funded by the Bill and Melinda Gates Foundation; Clinical Trials number, NCT02148952 .).",2017,"Among 4888 observed births, birth attendants' mean practice adherence was significantly higher in the intervention group than in the control group (72.8% vs. 41.7% at 2 months; 61.7% vs. 43.9% at 12 months; P<0.001 for both comparisons).","['India', '60 pairs of facilities across 24 districts of Uttar Pradesh, India, testing the effect of the BetterBirth program, an 8-month coaching-based implementation of the Safe Childbirth Checklist, on a', '161,107 eligible women', ""birth attendants' adherence to 18 essential birth practices in 15 matched pairs of facilities at 2 and 12 months after the initiation of the intervention""]",['Coaching-Based WHO Safe Childbirth Checklist Program'],"['secondary maternal or perinatal adverse outcomes', 'maternal and perinatal mortality and maternal morbidity', 'World Health Organization (WHO', 'composite outcome of perinatal death, maternal death, or maternal severe complications', ""birth attendants' mean practice adherence""]","[{'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0205224', 'cui_str': 'Essential (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}]","[{'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0031062', 'cui_str': 'Perinatal Mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0701826', 'cui_str': 'Perinatal death (event)'}, {'cui': 'C3494405', 'cui_str': 'Maternal Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",161107.0,0.180411,"Among 4888 observed births, birth attendants' mean practice adherence was significantly higher in the intervention group than in the control group (72.8% vs. 41.7% at 2 months; 61.7% vs. 43.9% at 12 months; P<0.001 for both comparisons).","[{'ForeName': 'Katherine E A', 'Initials': 'KEA', 'LastName': 'Semrau', 'Affiliation': ""From Ariadne Labs-Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health (K.E.A.S., M.M.D., D.E.T., S.L., A.A.G.), the Divisions of Global Health Equity (K.E.A.S.) and General Internal Medicine (S.L.) and the Department of Surgery (A.A.G.), Brigham and Women's Hospital, the Department of Medicine, Harvard Medical School (K.E.A.S.), and the Department of Health Policy and Management, Harvard T.H. Chan School of Public Health (A.A.G.) - all in Boston; Feinberg School of Medicine, Northwestern University, Chicago (L.R.H.); Population Services International (V.P.S., R.S., N.S.) and the Community Empowerment Lab (V.K.), Lucknow, and Jawaharlal Nehru Medical College, Belgaum (B.S.K.) - all in India; Population Services International, Washington, DC (R.F.); and the World Health Organization, Geneva (N.D.-K.).""}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Hirschhorn', 'Affiliation': ""From Ariadne Labs-Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health (K.E.A.S., M.M.D., D.E.T., S.L., A.A.G.), the Divisions of Global Health Equity (K.E.A.S.) and General Internal Medicine (S.L.) and the Department of Surgery (A.A.G.), Brigham and Women's Hospital, the Department of Medicine, Harvard Medical School (K.E.A.S.), and the Department of Health Policy and Management, Harvard T.H. Chan School of Public Health (A.A.G.) - all in Boston; Feinberg School of Medicine, Northwestern University, Chicago (L.R.H.); Population Services International (V.P.S., R.S., N.S.) and the Community Empowerment Lab (V.K.), Lucknow, and Jawaharlal Nehru Medical College, Belgaum (B.S.K.) - all in India; Population Services International, Washington, DC (R.F.); and the World Health Organization, Geneva (N.D.-K.).""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Marx Delaney', 'Affiliation': ""From Ariadne Labs-Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health (K.E.A.S., M.M.D., D.E.T., S.L., A.A.G.), the Divisions of Global Health Equity (K.E.A.S.) and General Internal Medicine (S.L.) and the Department of Surgery (A.A.G.), Brigham and Women's Hospital, the Department of Medicine, Harvard Medical School (K.E.A.S.), and the Department of Health Policy and Management, Harvard T.H. Chan School of Public Health (A.A.G.) - all in Boston; Feinberg School of Medicine, Northwestern University, Chicago (L.R.H.); Population Services International (V.P.S., R.S., N.S.) and the Community Empowerment Lab (V.K.), Lucknow, and Jawaharlal Nehru Medical College, Belgaum (B.S.K.) - all in India; Population Services International, Washington, DC (R.F.); and the World Health Organization, Geneva (N.D.-K.).""}, {'ForeName': 'Vinay P', 'Initials': 'VP', 'LastName': 'Singh', 'Affiliation': ""From Ariadne Labs-Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health (K.E.A.S., M.M.D., D.E.T., S.L., A.A.G.), the Divisions of Global Health Equity (K.E.A.S.) and General Internal Medicine (S.L.) and the Department of Surgery (A.A.G.), Brigham and Women's Hospital, the Department of Medicine, Harvard Medical School (K.E.A.S.), and the Department of Health Policy and Management, Harvard T.H. Chan School of Public Health (A.A.G.) - all in Boston; Feinberg School of Medicine, Northwestern University, Chicago (L.R.H.); Population Services International (V.P.S., R.S., N.S.) and the Community Empowerment Lab (V.K.), Lucknow, and Jawaharlal Nehru Medical College, Belgaum (B.S.K.) - all in India; Population Services International, Washington, DC (R.F.); and the World Health Organization, Geneva (N.D.-K.).""}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Saurastri', 'Affiliation': ""From Ariadne Labs-Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health (K.E.A.S., M.M.D., D.E.T., S.L., A.A.G.), the Divisions of Global Health Equity (K.E.A.S.) and General Internal Medicine (S.L.) and the Department of Surgery (A.A.G.), Brigham and Women's Hospital, the Department of Medicine, Harvard Medical School (K.E.A.S.), and the Department of Health Policy and Management, Harvard T.H. Chan School of Public Health (A.A.G.) - all in Boston; Feinberg School of Medicine, Northwestern University, Chicago (L.R.H.); Population Services International (V.P.S., R.S., N.S.) and the Community Empowerment Lab (V.K.), Lucknow, and Jawaharlal Nehru Medical College, Belgaum (B.S.K.) - all in India; Population Services International, Washington, DC (R.F.); and the World Health Organization, Geneva (N.D.-K.).""}, {'ForeName': 'Narender', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': ""From Ariadne Labs-Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health (K.E.A.S., M.M.D., D.E.T., S.L., A.A.G.), the Divisions of Global Health Equity (K.E.A.S.) and General Internal Medicine (S.L.) and the Department of Surgery (A.A.G.), Brigham and Women's Hospital, the Department of Medicine, Harvard Medical School (K.E.A.S.), and the Department of Health Policy and Management, Harvard T.H. Chan School of Public Health (A.A.G.) - all in Boston; Feinberg School of Medicine, Northwestern University, Chicago (L.R.H.); Population Services International (V.P.S., R.S., N.S.) and the Community Empowerment Lab (V.K.), Lucknow, and Jawaharlal Nehru Medical College, Belgaum (B.S.K.) - all in India; Population Services International, Washington, DC (R.F.); and the World Health Organization, Geneva (N.D.-K.).""}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Tuller', 'Affiliation': ""From Ariadne Labs-Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health (K.E.A.S., M.M.D., D.E.T., S.L., A.A.G.), the Divisions of Global Health Equity (K.E.A.S.) and General Internal Medicine (S.L.) and the Department of Surgery (A.A.G.), Brigham and Women's Hospital, the Department of Medicine, Harvard Medical School (K.E.A.S.), and the Department of Health Policy and Management, Harvard T.H. Chan School of Public Health (A.A.G.) - all in Boston; Feinberg School of Medicine, Northwestern University, Chicago (L.R.H.); Population Services International (V.P.S., R.S., N.S.) and the Community Empowerment Lab (V.K.), Lucknow, and Jawaharlal Nehru Medical College, Belgaum (B.S.K.) - all in India; Population Services International, Washington, DC (R.F.); and the World Health Organization, Geneva (N.D.-K.).""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Firestone', 'Affiliation': ""From Ariadne Labs-Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health (K.E.A.S., M.M.D., D.E.T., S.L., A.A.G.), the Divisions of Global Health Equity (K.E.A.S.) and General Internal Medicine (S.L.) and the Department of Surgery (A.A.G.), Brigham and Women's Hospital, the Department of Medicine, Harvard Medical School (K.E.A.S.), and the Department of Health Policy and Management, Harvard T.H. Chan School of Public Health (A.A.G.) - all in Boston; Feinberg School of Medicine, Northwestern University, Chicago (L.R.H.); Population Services International (V.P.S., R.S., N.S.) and the Community Empowerment Lab (V.K.), Lucknow, and Jawaharlal Nehru Medical College, Belgaum (B.S.K.) - all in India; Population Services International, Washington, DC (R.F.); and the World Health Organization, Geneva (N.D.-K.).""}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Lipsitz', 'Affiliation': ""From Ariadne Labs-Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health (K.E.A.S., M.M.D., D.E.T., S.L., A.A.G.), the Divisions of Global Health Equity (K.E.A.S.) and General Internal Medicine (S.L.) and the Department of Surgery (A.A.G.), Brigham and Women's Hospital, the Department of Medicine, Harvard Medical School (K.E.A.S.), and the Department of Health Policy and Management, Harvard T.H. Chan School of Public Health (A.A.G.) - all in Boston; Feinberg School of Medicine, Northwestern University, Chicago (L.R.H.); Population Services International (V.P.S., R.S., N.S.) and the Community Empowerment Lab (V.K.), Lucknow, and Jawaharlal Nehru Medical College, Belgaum (B.S.K.) - all in India; Population Services International, Washington, DC (R.F.); and the World Health Organization, Geneva (N.D.-K.).""}, {'ForeName': 'Neelam', 'Initials': 'N', 'LastName': 'Dhingra-Kumar', 'Affiliation': ""From Ariadne Labs-Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health (K.E.A.S., M.M.D., D.E.T., S.L., A.A.G.), the Divisions of Global Health Equity (K.E.A.S.) and General Internal Medicine (S.L.) and the Department of Surgery (A.A.G.), Brigham and Women's Hospital, the Department of Medicine, Harvard Medical School (K.E.A.S.), and the Department of Health Policy and Management, Harvard T.H. Chan School of Public Health (A.A.G.) - all in Boston; Feinberg School of Medicine, Northwestern University, Chicago (L.R.H.); Population Services International (V.P.S., R.S., N.S.) and the Community Empowerment Lab (V.K.), Lucknow, and Jawaharlal Nehru Medical College, Belgaum (B.S.K.) - all in India; Population Services International, Washington, DC (R.F.); and the World Health Organization, Geneva (N.D.-K.).""}, {'ForeName': 'Bhalachandra S', 'Initials': 'BS', 'LastName': 'Kodkany', 'Affiliation': ""From Ariadne Labs-Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health (K.E.A.S., M.M.D., D.E.T., S.L., A.A.G.), the Divisions of Global Health Equity (K.E.A.S.) and General Internal Medicine (S.L.) and the Department of Surgery (A.A.G.), Brigham and Women's Hospital, the Department of Medicine, Harvard Medical School (K.E.A.S.), and the Department of Health Policy and Management, Harvard T.H. Chan School of Public Health (A.A.G.) - all in Boston; Feinberg School of Medicine, Northwestern University, Chicago (L.R.H.); Population Services International (V.P.S., R.S., N.S.) and the Community Empowerment Lab (V.K.), Lucknow, and Jawaharlal Nehru Medical College, Belgaum (B.S.K.) - all in India; Population Services International, Washington, DC (R.F.); and the World Health Organization, Geneva (N.D.-K.).""}, {'ForeName': 'Vishwajeet', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': ""From Ariadne Labs-Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health (K.E.A.S., M.M.D., D.E.T., S.L., A.A.G.), the Divisions of Global Health Equity (K.E.A.S.) and General Internal Medicine (S.L.) and the Department of Surgery (A.A.G.), Brigham and Women's Hospital, the Department of Medicine, Harvard Medical School (K.E.A.S.), and the Department of Health Policy and Management, Harvard T.H. Chan School of Public Health (A.A.G.) - all in Boston; Feinberg School of Medicine, Northwestern University, Chicago (L.R.H.); Population Services International (V.P.S., R.S., N.S.) and the Community Empowerment Lab (V.K.), Lucknow, and Jawaharlal Nehru Medical College, Belgaum (B.S.K.) - all in India; Population Services International, Washington, DC (R.F.); and the World Health Organization, Geneva (N.D.-K.).""}, {'ForeName': 'Atul A', 'Initials': 'AA', 'LastName': 'Gawande', 'Affiliation': ""From Ariadne Labs-Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health (K.E.A.S., M.M.D., D.E.T., S.L., A.A.G.), the Divisions of Global Health Equity (K.E.A.S.) and General Internal Medicine (S.L.) and the Department of Surgery (A.A.G.), Brigham and Women's Hospital, the Department of Medicine, Harvard Medical School (K.E.A.S.), and the Department of Health Policy and Management, Harvard T.H. Chan School of Public Health (A.A.G.) - all in Boston; Feinberg School of Medicine, Northwestern University, Chicago (L.R.H.); Population Services International (V.P.S., R.S., N.S.) and the Community Empowerment Lab (V.K.), Lucknow, and Jawaharlal Nehru Medical College, Belgaum (B.S.K.) - all in India; Population Services International, Washington, DC (R.F.); and the World Health Organization, Geneva (N.D.-K.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1701075']
770,31608821,Reactions to ideal body shapes.,"Difficult-to-attain beauty standards that are promulgated by the media could contribute to body dissatisfaction, but their potential impact upon body image remains unclear. The present study examined reactions to thin-ideal and muscular-ideal images, and examined the effects of ideal image exposure on preferred body shape and time spent deliberating about ideal shape. In a 2 × 2 experimental design, 200 Internet users completed the Kessler psychological distress scale (K10) and were randomly assigned to view idealistic body images or houses (and rated them on semantic differential dimensions). Females viewed thin ideal images and males viewed muscular ideal images, while the control groups viewed images of houses. Between group measures analysis of variance revealed women reacted negatively to thinspirational images. Women were more driven for thinness and idealized a thinner shape for the female body than men. Psychologically distressed participants had a stronger drive for thinness and greater body dissatisfaction compared to low-distress participants. In addition, although beauty ideal imagery had no significant impact on males, females spent more time in choosing ideal body figure. Viewing thin bodies for females created a trend toward desiring a slimmer figure, as well as increased preoccupation with size as they spent more time deliberating over a photorealistic figure rating scale. Therefore, exposure to thinspiration promotes dissatisfaction with self and leads women to dwell more upon their body image.",2020,Psychologically distressed participants had a stronger drive for thinness and greater body dissatisfaction compared to low-distress participants.,"['200 Internet users completed the Kessler psychological distress scale (K10', 'Psychologically distressed participants']",[],['stronger drive for thinness and greater body dissatisfaction'],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0222045'}]",[],"[{'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0039870', 'cui_str': 'Leanness'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",200.0,0.0182561,Psychologically distressed participants had a stronger drive for thinness and greater body dissatisfaction compared to low-distress participants.,"[{'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Prnjak', 'Affiliation': 'Western Sydney University.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Pemberton', 'Affiliation': 'Auckland University of Technology.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Helms', 'Affiliation': 'Auckland University of Technology.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Phillips', 'Affiliation': 'Auckland University of Technology.'}]",The Journal of general psychology,['10.1080/00221309.2019.1676190']
771,31608799,Pharmacodynamic comparison of low-dose ticagrelor to low-dose prasugrel in patients with prior myocardial infarction: the ALTIC-2 study.,"Given that patients with prior myocardial infarction and features of high ischemic and low bleeding risk may benefit by extending dual antiplatelet therapy beyond 1 year, we aimed of assessing platelet reactivity provided by ticagrelor 60 mg bid versus prasugrel 5 mg od in 20 such patients participating in a randomized, crossover study. The primary end point of platelet reactivity at the end of the two treatment periods (by VerifyNow, in PRU) was significantly lower for ticagrelor (31.9 PRU [95% CI 12.3-51.4]) compared with prasugrel (132.1 PRU [111.9-152.3]) with a least squares mean difference of -100.2 PRU (72.1-128.3,  P  < .001). This dedicated pharmacodynamic study showed that in post-myocardial infarction patients with high atherothrombotic risk and receiving P2Y 12  receptor antagonist beyond 1 year, low-dose ticagrelor results in a significantly lower platelet reactivity compared to low-dose prasugrel.",2020,"This dedicated pharmacodynamic study showed that in post-myocardial infarction patients with high atherothrombotic risk and receiving P2Y 12  receptor antagonist beyond 1 year, low-dose ticagrelor results in a significantly lower platelet reactivity compared to low-dose prasugrel.","['myocardial infarction patients with high atherothrombotic risk', 'patients with prior myocardial infarction']","['low-dose ticagrelor', 'ticagrelor', 'ticagrelor 60 mg bid versus prasugrel']","['platelet reactivity', 'VerifyNow, in PRU']","[{'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C4051377', 'cui_str': 'Ticagrelor 60 MG'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}]","[{'cui': 'C0005821', 'cui_str': 'Platelets'}]",,0.0459017,"This dedicated pharmacodynamic study showed that in post-myocardial infarction patients with high atherothrombotic risk and receiving P2Y 12  receptor antagonist beyond 1 year, low-dose ticagrelor results in a significantly lower platelet reactivity compared to low-dose prasugrel.","[{'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Alexopoulos', 'Affiliation': '2nd Department of Cardiology, Attikon University Hospital, National and Kapodistrian University of Athens Medical School , Athens, Greece.'}, {'ForeName': 'Danai', 'Initials': 'D', 'LastName': 'Sfantou', 'Affiliation': '2nd Department of Cardiology, Attikon University Hospital, National and Kapodistrian University of Athens Medical School , Athens, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Lianos', 'Affiliation': '2nd Department of Cardiology, Attikon University Hospital, National and Kapodistrian University of Athens Medical School , Athens, Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Pappas', 'Affiliation': '2nd Department of Cardiology, Attikon University Hospital, National and Kapodistrian University of Athens Medical School , Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Revela', 'Affiliation': '2nd Department of Cardiology, Attikon University Hospital, National and Kapodistrian University of Athens Medical School , Athens, Greece.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Triantafyllidi', 'Affiliation': '2nd Department of Cardiology, Attikon University Hospital, National and Kapodistrian University of Athens Medical School , Athens, Greece.'}, {'ForeName': 'Ignatios', 'Initials': 'I', 'LastName': 'Ikonomidis', 'Affiliation': '2nd Department of Cardiology, Attikon University Hospital, National and Kapodistrian University of Athens Medical School , Athens, Greece.'}]",Platelets,['10.1080/09537104.2019.1678123']
772,29208679,TIME Trial: Effect of Timing of Stem Cell Delivery Following ST-Elevation Myocardial Infarction on the Recovery of Global and Regional Left Ventricular Function: Final 2-Year Analysis.,"RATIONALE


The TIME trial (Timing in Myocardial Infarction Evaluation) was the first cell therapy trial sufficiently powered to determine if timing of cell delivery after ST-segment-elevation myocardial infarction affects recovery of left ventricular (LV) function.
OBJECTIVE


To report the 2-year clinical and cardiac magnetic resonance imaging results and their modification by microvascular obstruction.
METHODS AND RESULTS


TIME was a randomized, double-blind, placebo-controlled trial comparing 150 million bone marrow mononuclear cells versus placebo in 120 patients with anterior ST-segment-elevation myocardial infarctions resulting in LV dysfunction. Primary end points included changes in global (LV ejection fraction) and regional (infarct and border zone) function. Secondary end points included changes in LV volumes, infarct size, and major adverse cardiac events. Here, we analyzed the continued trajectory of these measures out to 2 years and the influence of microvascular obstruction present at baseline on these long-term outcomes. At 2 years (n=85), LV ejection fraction was similar in the bone marrow mononuclear cells (48.7%) and placebo groups (51.6%) with no difference in regional LV function. Infarct size and LV mass decreased ≥30% in each group at 6 months and declined gradually to 2 years. LV volumes increased ≈10% at 6 months and remained stable to 2 years. Microvascular obstruction was present in 48 patients at baseline and was associated with significantly larger infarct size (56.5 versus 36.2 g), greater adverse LV remodeling, and marked reduction in LV ejection fraction recovery (0.2% versus 6.2%).
CONCLUSIONS


In one of the longest serial cardiac magnetic resonance imaging analyses of patients with large anterior ST-segment-elevation myocardial infarctions, bone marrow mononuclear cells administration did not improve recovery of LV function over 2 years. Microvascular obstruction was associated with reduced recovery of LV function, greater adverse LV remodeling, and more device implantations. The use of cardiac magnetic resonance imaging leads to greater dropout of patients over time because of device implantation in patients with more severe LV dysfunction resulting in overestimation of clinical stability of the cohort.
CLINICAL TRIAL REGISTRATION


URL: http://www.clinicaltrials.gov. Unique identifier: NCT00684021.",2018,"Microvascular obstruction was present in 48 patients at baseline and was associated with significantly larger infarct size (56.5 versus 36.2 g), greater adverse LV remodeling, and marked reduction in LV ejection fraction recovery (0.2% versus 6.2%).
","['patients with large anterior ST-segment-elevation myocardial infarctions', 'Function', 'patients with more severe LV dysfunction', '120 patients with anterior ST-segment-elevation myocardial infarctions resulting in LV dysfunction']","['cardiac magnetic resonance imaging', 'Stem Cell Delivery', 'placebo', '150 million bone marrow mononuclear cells versus placebo']","['LV ejection fraction recovery', 'LV volumes', 'recovery of LV function', 'changes in LV volumes, infarct size, and major adverse cardiac events', 'changes in global (LV ejection fraction) and regional (infarct and border zone) function', 'Infarct size and LV mass', 'adverse LV remodeling', 'Recovery of Global and Regional Left Ventricular', 'bone marrow mononuclear cells', 'Microvascular obstruction', 'recovery of LV function, greater adverse LV remodeling, and more device implantations', 'LV ejection fraction', 'regional LV function', 'larger infarct size']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C3874460', 'cui_str': 'Anterior ST segment elevation'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}]","[{'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0007634', 'cui_str': 'Cells'}]","[{'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]",120.0,0.483192,"Microvascular obstruction was present in 48 patients at baseline and was associated with significantly larger infarct size (56.5 versus 36.2 g), greater adverse LV remodeling, and marked reduction in LV ejection fraction recovery (0.2% versus 6.2%).
","[{'ForeName': 'Jay H', 'Initials': 'JH', 'LastName': 'Traverse', 'Affiliation': ""From the Department of Cardiology, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, MN (J.H.T., T.D.H.); Department of Medicine, University of Minnesota School of Medicine, Minneapolis (J.H.T., G.R.); Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA (T.D.H.); Department of Medicine, College of Medicine, University of Florida, Gainesville (C.J.P., J.R.F.); Stem Cell Center (J.T.W., E.C.P.), and Regenerative Medicine Research (D.A.T.), Texas Heart Institute, CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston; Franciscan Saint Francis Health, Indianapolis, IN (A.C.); Department of Cardiovascular Medicine, Stanford University School of Medicine, CA (P.C.Y.); Department of Cardiology, Wake Forest University School of Medicine, Winston-Salem, NC (D.X.M.Z.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, OH (S.G.E.); Summa Health Heart and Vascular Institute, Akron, OH (M.S.P.); Department of Cell and Developmental Biology, Vanderbilt University School of Medicine, Nashville, TN (A.K.H.); Metropolitan Heart and Vascular Institute, Mercy Hospital, Coon Rapids, MN (J.C.C.); United Heart and Vascular Clinic (K.W.B.); Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX (A.P.G.); Coordinating Center for Clinical Trials, UTHealth School of Public Health, Houston, TX (L.M.); National Heart Lung, and Blood Institute, Bethesda, MD (R.F.E.); and University of Kansas School of Medicine (R.D.S.).""}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Henry', 'Affiliation': ""From the Department of Cardiology, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, MN (J.H.T., T.D.H.); Department of Medicine, University of Minnesota School of Medicine, Minneapolis (J.H.T., G.R.); Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA (T.D.H.); Department of Medicine, College of Medicine, University of Florida, Gainesville (C.J.P., J.R.F.); Stem Cell Center (J.T.W., E.C.P.), and Regenerative Medicine Research (D.A.T.), Texas Heart Institute, CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston; Franciscan Saint Francis Health, Indianapolis, IN (A.C.); Department of Cardiovascular Medicine, Stanford University School of Medicine, CA (P.C.Y.); Department of Cardiology, Wake Forest University School of Medicine, Winston-Salem, NC (D.X.M.Z.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, OH (S.G.E.); Summa Health Heart and Vascular Institute, Akron, OH (M.S.P.); Department of Cell and Developmental Biology, Vanderbilt University School of Medicine, Nashville, TN (A.K.H.); Metropolitan Heart and Vascular Institute, Mercy Hospital, Coon Rapids, MN (J.C.C.); United Heart and Vascular Clinic (K.W.B.); Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX (A.P.G.); Coordinating Center for Clinical Trials, UTHealth School of Public Health, Houston, TX (L.M.); National Heart Lung, and Blood Institute, Bethesda, MD (R.F.E.); and University of Kansas School of Medicine (R.D.S.).""}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Pepine', 'Affiliation': ""From the Department of Cardiology, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, MN (J.H.T., T.D.H.); Department of Medicine, University of Minnesota School of Medicine, Minneapolis (J.H.T., G.R.); Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA (T.D.H.); Department of Medicine, College of Medicine, University of Florida, Gainesville (C.J.P., J.R.F.); Stem Cell Center (J.T.W., E.C.P.), and Regenerative Medicine Research (D.A.T.), Texas Heart Institute, CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston; Franciscan Saint Francis Health, Indianapolis, IN (A.C.); Department of Cardiovascular Medicine, Stanford University School of Medicine, CA (P.C.Y.); Department of Cardiology, Wake Forest University School of Medicine, Winston-Salem, NC (D.X.M.Z.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, OH (S.G.E.); Summa Health Heart and Vascular Institute, Akron, OH (M.S.P.); Department of Cell and Developmental Biology, Vanderbilt University School of Medicine, Nashville, TN (A.K.H.); Metropolitan Heart and Vascular Institute, Mercy Hospital, Coon Rapids, MN (J.C.C.); United Heart and Vascular Clinic (K.W.B.); Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX (A.P.G.); Coordinating Center for Clinical Trials, UTHealth School of Public Health, Houston, TX (L.M.); National Heart Lung, and Blood Institute, Bethesda, MD (R.F.E.); and University of Kansas School of Medicine (R.D.S.).""}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Willerson', 'Affiliation': ""From the Department of Cardiology, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, MN (J.H.T., T.D.H.); Department of Medicine, University of Minnesota School of Medicine, Minneapolis (J.H.T., G.R.); Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA (T.D.H.); Department of Medicine, College of Medicine, University of Florida, Gainesville (C.J.P., J.R.F.); Stem Cell Center (J.T.W., E.C.P.), and Regenerative Medicine Research (D.A.T.), Texas Heart Institute, CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston; Franciscan Saint Francis Health, Indianapolis, IN (A.C.); Department of Cardiovascular Medicine, Stanford University School of Medicine, CA (P.C.Y.); Department of Cardiology, Wake Forest University School of Medicine, Winston-Salem, NC (D.X.M.Z.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, OH (S.G.E.); Summa Health Heart and Vascular Institute, Akron, OH (M.S.P.); Department of Cell and Developmental Biology, Vanderbilt University School of Medicine, Nashville, TN (A.K.H.); Metropolitan Heart and Vascular Institute, Mercy Hospital, Coon Rapids, MN (J.C.C.); United Heart and Vascular Clinic (K.W.B.); Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX (A.P.G.); Coordinating Center for Clinical Trials, UTHealth School of Public Health, Houston, TX (L.M.); National Heart Lung, and Blood Institute, Bethesda, MD (R.F.E.); and University of Kansas School of Medicine (R.D.S.).""}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Chugh', 'Affiliation': ""From the Department of Cardiology, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, MN (J.H.T., T.D.H.); Department of Medicine, University of Minnesota School of Medicine, Minneapolis (J.H.T., G.R.); Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA (T.D.H.); Department of Medicine, College of Medicine, University of Florida, Gainesville (C.J.P., J.R.F.); Stem Cell Center (J.T.W., E.C.P.), and Regenerative Medicine Research (D.A.T.), Texas Heart Institute, CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston; Franciscan Saint Francis Health, Indianapolis, IN (A.C.); Department of Cardiovascular Medicine, Stanford University School of Medicine, CA (P.C.Y.); Department of Cardiology, Wake Forest University School of Medicine, Winston-Salem, NC (D.X.M.Z.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, OH (S.G.E.); Summa Health Heart and Vascular Institute, Akron, OH (M.S.P.); Department of Cell and Developmental Biology, Vanderbilt University School of Medicine, Nashville, TN (A.K.H.); Metropolitan Heart and Vascular Institute, Mercy Hospital, Coon Rapids, MN (J.C.C.); United Heart and Vascular Clinic (K.W.B.); Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX (A.P.G.); Coordinating Center for Clinical Trials, UTHealth School of Public Health, Houston, TX (L.M.); National Heart Lung, and Blood Institute, Bethesda, MD (R.F.E.); and University of Kansas School of Medicine (R.D.S.).""}, {'ForeName': 'Phillip C', 'Initials': 'PC', 'LastName': 'Yang', 'Affiliation': ""From the Department of Cardiology, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, MN (J.H.T., T.D.H.); Department of Medicine, University of Minnesota School of Medicine, Minneapolis (J.H.T., G.R.); Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA (T.D.H.); Department of Medicine, College of Medicine, University of Florida, Gainesville (C.J.P., J.R.F.); Stem Cell Center (J.T.W., E.C.P.), and Regenerative Medicine Research (D.A.T.), Texas Heart Institute, CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston; Franciscan Saint Francis Health, Indianapolis, IN (A.C.); Department of Cardiovascular Medicine, Stanford University School of Medicine, CA (P.C.Y.); Department of Cardiology, Wake Forest University School of Medicine, Winston-Salem, NC (D.X.M.Z.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, OH (S.G.E.); Summa Health Heart and Vascular Institute, Akron, OH (M.S.P.); Department of Cell and Developmental Biology, Vanderbilt University School of Medicine, Nashville, TN (A.K.H.); Metropolitan Heart and Vascular Institute, Mercy Hospital, Coon Rapids, MN (J.C.C.); United Heart and Vascular Clinic (K.W.B.); Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX (A.P.G.); Coordinating Center for Clinical Trials, UTHealth School of Public Health, Houston, TX (L.M.); National Heart Lung, and Blood Institute, Bethesda, MD (R.F.E.); and University of Kansas School of Medicine (R.D.S.).""}, {'ForeName': 'David X M', 'Initials': 'DXM', 'LastName': 'Zhao', 'Affiliation': ""From the Department of Cardiology, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, MN (J.H.T., T.D.H.); Department of Medicine, University of Minnesota School of Medicine, Minneapolis (J.H.T., G.R.); Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA (T.D.H.); Department of Medicine, College of Medicine, University of Florida, Gainesville (C.J.P., J.R.F.); Stem Cell Center (J.T.W., E.C.P.), and Regenerative Medicine Research (D.A.T.), Texas Heart Institute, CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston; Franciscan Saint Francis Health, Indianapolis, IN (A.C.); Department of Cardiovascular Medicine, Stanford University School of Medicine, CA (P.C.Y.); Department of Cardiology, Wake Forest University School of Medicine, Winston-Salem, NC (D.X.M.Z.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, OH (S.G.E.); Summa Health Heart and Vascular Institute, Akron, OH (M.S.P.); Department of Cell and Developmental Biology, Vanderbilt University School of Medicine, Nashville, TN (A.K.H.); Metropolitan Heart and Vascular Institute, Mercy Hospital, Coon Rapids, MN (J.C.C.); United Heart and Vascular Clinic (K.W.B.); Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX (A.P.G.); Coordinating Center for Clinical Trials, UTHealth School of Public Health, Houston, TX (L.M.); National Heart Lung, and Blood Institute, Bethesda, MD (R.F.E.); and University of Kansas School of Medicine (R.D.S.).""}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Ellis', 'Affiliation': ""From the Department of Cardiology, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, MN (J.H.T., T.D.H.); Department of Medicine, University of Minnesota School of Medicine, Minneapolis (J.H.T., G.R.); Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA (T.D.H.); Department of Medicine, College of Medicine, University of Florida, Gainesville (C.J.P., J.R.F.); Stem Cell Center (J.T.W., E.C.P.), and Regenerative Medicine Research (D.A.T.), Texas Heart Institute, CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston; Franciscan Saint Francis Health, Indianapolis, IN (A.C.); Department of Cardiovascular Medicine, Stanford University School of Medicine, CA (P.C.Y.); Department of Cardiology, Wake Forest University School of Medicine, Winston-Salem, NC (D.X.M.Z.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, OH (S.G.E.); Summa Health Heart and Vascular Institute, Akron, OH (M.S.P.); Department of Cell and Developmental Biology, Vanderbilt University School of Medicine, Nashville, TN (A.K.H.); Metropolitan Heart and Vascular Institute, Mercy Hospital, Coon Rapids, MN (J.C.C.); United Heart and Vascular Clinic (K.W.B.); Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX (A.P.G.); Coordinating Center for Clinical Trials, UTHealth School of Public Health, Houston, TX (L.M.); National Heart Lung, and Blood Institute, Bethesda, MD (R.F.E.); and University of Kansas School of Medicine (R.D.S.).""}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Forder', 'Affiliation': ""From the Department of Cardiology, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, MN (J.H.T., T.D.H.); Department of Medicine, University of Minnesota School of Medicine, Minneapolis (J.H.T., G.R.); Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA (T.D.H.); Department of Medicine, College of Medicine, University of Florida, Gainesville (C.J.P., J.R.F.); Stem Cell Center (J.T.W., E.C.P.), and Regenerative Medicine Research (D.A.T.), Texas Heart Institute, CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston; Franciscan Saint Francis Health, Indianapolis, IN (A.C.); Department of Cardiovascular Medicine, Stanford University School of Medicine, CA (P.C.Y.); Department of Cardiology, Wake Forest University School of Medicine, Winston-Salem, NC (D.X.M.Z.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, OH (S.G.E.); Summa Health Heart and Vascular Institute, Akron, OH (M.S.P.); Department of Cell and Developmental Biology, Vanderbilt University School of Medicine, Nashville, TN (A.K.H.); Metropolitan Heart and Vascular Institute, Mercy Hospital, Coon Rapids, MN (J.C.C.); United Heart and Vascular Clinic (K.W.B.); Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX (A.P.G.); Coordinating Center for Clinical Trials, UTHealth School of Public Health, Houston, TX (L.M.); National Heart Lung, and Blood Institute, Bethesda, MD (R.F.E.); and University of Kansas School of Medicine (R.D.S.).""}, {'ForeName': 'Emerson C', 'Initials': 'EC', 'LastName': 'Perin', 'Affiliation': ""From the Department of Cardiology, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, MN (J.H.T., T.D.H.); Department of Medicine, University of Minnesota School of Medicine, Minneapolis (J.H.T., G.R.); Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA (T.D.H.); Department of Medicine, College of Medicine, University of Florida, Gainesville (C.J.P., J.R.F.); Stem Cell Center (J.T.W., E.C.P.), and Regenerative Medicine Research (D.A.T.), Texas Heart Institute, CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston; Franciscan Saint Francis Health, Indianapolis, IN (A.C.); Department of Cardiovascular Medicine, Stanford University School of Medicine, CA (P.C.Y.); Department of Cardiology, Wake Forest University School of Medicine, Winston-Salem, NC (D.X.M.Z.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, OH (S.G.E.); Summa Health Heart and Vascular Institute, Akron, OH (M.S.P.); Department of Cell and Developmental Biology, Vanderbilt University School of Medicine, Nashville, TN (A.K.H.); Metropolitan Heart and Vascular Institute, Mercy Hospital, Coon Rapids, MN (J.C.C.); United Heart and Vascular Clinic (K.W.B.); Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX (A.P.G.); Coordinating Center for Clinical Trials, UTHealth School of Public Health, Houston, TX (L.M.); National Heart Lung, and Blood Institute, Bethesda, MD (R.F.E.); and University of Kansas School of Medicine (R.D.S.).""}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Penn', 'Affiliation': ""From the Department of Cardiology, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, MN (J.H.T., T.D.H.); Department of Medicine, University of Minnesota School of Medicine, Minneapolis (J.H.T., G.R.); Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA (T.D.H.); Department of Medicine, College of Medicine, University of Florida, Gainesville (C.J.P., J.R.F.); Stem Cell Center (J.T.W., E.C.P.), and Regenerative Medicine Research (D.A.T.), Texas Heart Institute, CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston; Franciscan Saint Francis Health, Indianapolis, IN (A.C.); Department of Cardiovascular Medicine, Stanford University School of Medicine, CA (P.C.Y.); Department of Cardiology, Wake Forest University School of Medicine, Winston-Salem, NC (D.X.M.Z.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, OH (S.G.E.); Summa Health Heart and Vascular Institute, Akron, OH (M.S.P.); Department of Cell and Developmental Biology, Vanderbilt University School of Medicine, Nashville, TN (A.K.H.); Metropolitan Heart and Vascular Institute, Mercy Hospital, Coon Rapids, MN (J.C.C.); United Heart and Vascular Clinic (K.W.B.); Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX (A.P.G.); Coordinating Center for Clinical Trials, UTHealth School of Public Health, Houston, TX (L.M.); National Heart Lung, and Blood Institute, Bethesda, MD (R.F.E.); and University of Kansas School of Medicine (R.D.S.).""}, {'ForeName': 'Antonis K', 'Initials': 'AK', 'LastName': 'Hatzopoulos', 'Affiliation': ""From the Department of Cardiology, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, MN (J.H.T., T.D.H.); Department of Medicine, University of Minnesota School of Medicine, Minneapolis (J.H.T., G.R.); Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA (T.D.H.); Department of Medicine, College of Medicine, University of Florida, Gainesville (C.J.P., J.R.F.); Stem Cell Center (J.T.W., E.C.P.), and Regenerative Medicine Research (D.A.T.), Texas Heart Institute, CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston; Franciscan Saint Francis Health, Indianapolis, IN (A.C.); Department of Cardiovascular Medicine, Stanford University School of Medicine, CA (P.C.Y.); Department of Cardiology, Wake Forest University School of Medicine, Winston-Salem, NC (D.X.M.Z.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, OH (S.G.E.); Summa Health Heart and Vascular Institute, Akron, OH (M.S.P.); Department of Cell and Developmental Biology, Vanderbilt University School of Medicine, Nashville, TN (A.K.H.); Metropolitan Heart and Vascular Institute, Mercy Hospital, Coon Rapids, MN (J.C.C.); United Heart and Vascular Clinic (K.W.B.); Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX (A.P.G.); Coordinating Center for Clinical Trials, UTHealth School of Public Health, Houston, TX (L.M.); National Heart Lung, and Blood Institute, Bethesda, MD (R.F.E.); and University of Kansas School of Medicine (R.D.S.).""}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Chambers', 'Affiliation': ""From the Department of Cardiology, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, MN (J.H.T., T.D.H.); Department of Medicine, University of Minnesota School of Medicine, Minneapolis (J.H.T., G.R.); Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA (T.D.H.); Department of Medicine, College of Medicine, University of Florida, Gainesville (C.J.P., J.R.F.); Stem Cell Center (J.T.W., E.C.P.), and Regenerative Medicine Research (D.A.T.), Texas Heart Institute, CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston; Franciscan Saint Francis Health, Indianapolis, IN (A.C.); Department of Cardiovascular Medicine, Stanford University School of Medicine, CA (P.C.Y.); Department of Cardiology, Wake Forest University School of Medicine, Winston-Salem, NC (D.X.M.Z.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, OH (S.G.E.); Summa Health Heart and Vascular Institute, Akron, OH (M.S.P.); Department of Cell and Developmental Biology, Vanderbilt University School of Medicine, Nashville, TN (A.K.H.); Metropolitan Heart and Vascular Institute, Mercy Hospital, Coon Rapids, MN (J.C.C.); United Heart and Vascular Clinic (K.W.B.); Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX (A.P.G.); Coordinating Center for Clinical Trials, UTHealth School of Public Health, Houston, TX (L.M.); National Heart Lung, and Blood Institute, Bethesda, MD (R.F.E.); and University of Kansas School of Medicine (R.D.S.).""}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Baran', 'Affiliation': ""From the Department of Cardiology, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, MN (J.H.T., T.D.H.); Department of Medicine, University of Minnesota School of Medicine, Minneapolis (J.H.T., G.R.); Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA (T.D.H.); Department of Medicine, College of Medicine, University of Florida, Gainesville (C.J.P., J.R.F.); Stem Cell Center (J.T.W., E.C.P.), and Regenerative Medicine Research (D.A.T.), Texas Heart Institute, CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston; Franciscan Saint Francis Health, Indianapolis, IN (A.C.); Department of Cardiovascular Medicine, Stanford University School of Medicine, CA (P.C.Y.); Department of Cardiology, Wake Forest University School of Medicine, Winston-Salem, NC (D.X.M.Z.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, OH (S.G.E.); Summa Health Heart and Vascular Institute, Akron, OH (M.S.P.); Department of Cell and Developmental Biology, Vanderbilt University School of Medicine, Nashville, TN (A.K.H.); Metropolitan Heart and Vascular Institute, Mercy Hospital, Coon Rapids, MN (J.C.C.); United Heart and Vascular Clinic (K.W.B.); Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX (A.P.G.); Coordinating Center for Clinical Trials, UTHealth School of Public Health, Houston, TX (L.M.); National Heart Lung, and Blood Institute, Bethesda, MD (R.F.E.); and University of Kansas School of Medicine (R.D.S.).""}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Raveendran', 'Affiliation': ""From the Department of Cardiology, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, MN (J.H.T., T.D.H.); Department of Medicine, University of Minnesota School of Medicine, Minneapolis (J.H.T., G.R.); Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA (T.D.H.); Department of Medicine, College of Medicine, University of Florida, Gainesville (C.J.P., J.R.F.); Stem Cell Center (J.T.W., E.C.P.), and Regenerative Medicine Research (D.A.T.), Texas Heart Institute, CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston; Franciscan Saint Francis Health, Indianapolis, IN (A.C.); Department of Cardiovascular Medicine, Stanford University School of Medicine, CA (P.C.Y.); Department of Cardiology, Wake Forest University School of Medicine, Winston-Salem, NC (D.X.M.Z.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, OH (S.G.E.); Summa Health Heart and Vascular Institute, Akron, OH (M.S.P.); Department of Cell and Developmental Biology, Vanderbilt University School of Medicine, Nashville, TN (A.K.H.); Metropolitan Heart and Vascular Institute, Mercy Hospital, Coon Rapids, MN (J.C.C.); United Heart and Vascular Clinic (K.W.B.); Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX (A.P.G.); Coordinating Center for Clinical Trials, UTHealth School of Public Health, Houston, TX (L.M.); National Heart Lung, and Blood Institute, Bethesda, MD (R.F.E.); and University of Kansas School of Medicine (R.D.S.).""}, {'ForeName': 'Adrian P', 'Initials': 'AP', 'LastName': 'Gee', 'Affiliation': ""From the Department of Cardiology, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, MN (J.H.T., T.D.H.); Department of Medicine, University of Minnesota School of Medicine, Minneapolis (J.H.T., G.R.); Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA (T.D.H.); Department of Medicine, College of Medicine, University of Florida, Gainesville (C.J.P., J.R.F.); Stem Cell Center (J.T.W., E.C.P.), and Regenerative Medicine Research (D.A.T.), Texas Heart Institute, CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston; Franciscan Saint Francis Health, Indianapolis, IN (A.C.); Department of Cardiovascular Medicine, Stanford University School of Medicine, CA (P.C.Y.); Department of Cardiology, Wake Forest University School of Medicine, Winston-Salem, NC (D.X.M.Z.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, OH (S.G.E.); Summa Health Heart and Vascular Institute, Akron, OH (M.S.P.); Department of Cell and Developmental Biology, Vanderbilt University School of Medicine, Nashville, TN (A.K.H.); Metropolitan Heart and Vascular Institute, Mercy Hospital, Coon Rapids, MN (J.C.C.); United Heart and Vascular Clinic (K.W.B.); Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX (A.P.G.); Coordinating Center for Clinical Trials, UTHealth School of Public Health, Houston, TX (L.M.); National Heart Lung, and Blood Institute, Bethesda, MD (R.F.E.); and University of Kansas School of Medicine (R.D.S.).""}, {'ForeName': 'Doris A', 'Initials': 'DA', 'LastName': 'Taylor', 'Affiliation': ""From the Department of Cardiology, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, MN (J.H.T., T.D.H.); Department of Medicine, University of Minnesota School of Medicine, Minneapolis (J.H.T., G.R.); Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA (T.D.H.); Department of Medicine, College of Medicine, University of Florida, Gainesville (C.J.P., J.R.F.); Stem Cell Center (J.T.W., E.C.P.), and Regenerative Medicine Research (D.A.T.), Texas Heart Institute, CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston; Franciscan Saint Francis Health, Indianapolis, IN (A.C.); Department of Cardiovascular Medicine, Stanford University School of Medicine, CA (P.C.Y.); Department of Cardiology, Wake Forest University School of Medicine, Winston-Salem, NC (D.X.M.Z.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, OH (S.G.E.); Summa Health Heart and Vascular Institute, Akron, OH (M.S.P.); Department of Cell and Developmental Biology, Vanderbilt University School of Medicine, Nashville, TN (A.K.H.); Metropolitan Heart and Vascular Institute, Mercy Hospital, Coon Rapids, MN (J.C.C.); United Heart and Vascular Clinic (K.W.B.); Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX (A.P.G.); Coordinating Center for Clinical Trials, UTHealth School of Public Health, Houston, TX (L.M.); National Heart Lung, and Blood Institute, Bethesda, MD (R.F.E.); and University of Kansas School of Medicine (R.D.S.).""}, {'ForeName': 'Lem', 'Initials': 'L', 'LastName': 'Moyé', 'Affiliation': ""From the Department of Cardiology, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, MN (J.H.T., T.D.H.); Department of Medicine, University of Minnesota School of Medicine, Minneapolis (J.H.T., G.R.); Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA (T.D.H.); Department of Medicine, College of Medicine, University of Florida, Gainesville (C.J.P., J.R.F.); Stem Cell Center (J.T.W., E.C.P.), and Regenerative Medicine Research (D.A.T.), Texas Heart Institute, CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston; Franciscan Saint Francis Health, Indianapolis, IN (A.C.); Department of Cardiovascular Medicine, Stanford University School of Medicine, CA (P.C.Y.); Department of Cardiology, Wake Forest University School of Medicine, Winston-Salem, NC (D.X.M.Z.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, OH (S.G.E.); Summa Health Heart and Vascular Institute, Akron, OH (M.S.P.); Department of Cell and Developmental Biology, Vanderbilt University School of Medicine, Nashville, TN (A.K.H.); Metropolitan Heart and Vascular Institute, Mercy Hospital, Coon Rapids, MN (J.C.C.); United Heart and Vascular Clinic (K.W.B.); Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX (A.P.G.); Coordinating Center for Clinical Trials, UTHealth School of Public Health, Houston, TX (L.M.); National Heart Lung, and Blood Institute, Bethesda, MD (R.F.E.); and University of Kansas School of Medicine (R.D.S.). lemmoye@msn.com.""}, {'ForeName': 'Ray F', 'Initials': 'RF', 'LastName': 'Ebert', 'Affiliation': ""From the Department of Cardiology, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, MN (J.H.T., T.D.H.); Department of Medicine, University of Minnesota School of Medicine, Minneapolis (J.H.T., G.R.); Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA (T.D.H.); Department of Medicine, College of Medicine, University of Florida, Gainesville (C.J.P., J.R.F.); Stem Cell Center (J.T.W., E.C.P.), and Regenerative Medicine Research (D.A.T.), Texas Heart Institute, CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston; Franciscan Saint Francis Health, Indianapolis, IN (A.C.); Department of Cardiovascular Medicine, Stanford University School of Medicine, CA (P.C.Y.); Department of Cardiology, Wake Forest University School of Medicine, Winston-Salem, NC (D.X.M.Z.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, OH (S.G.E.); Summa Health Heart and Vascular Institute, Akron, OH (M.S.P.); Department of Cell and Developmental Biology, Vanderbilt University School of Medicine, Nashville, TN (A.K.H.); Metropolitan Heart and Vascular Institute, Mercy Hospital, Coon Rapids, MN (J.C.C.); United Heart and Vascular Clinic (K.W.B.); Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX (A.P.G.); Coordinating Center for Clinical Trials, UTHealth School of Public Health, Houston, TX (L.M.); National Heart Lung, and Blood Institute, Bethesda, MD (R.F.E.); and University of Kansas School of Medicine (R.D.S.).""}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Simari', 'Affiliation': ""From the Department of Cardiology, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, MN (J.H.T., T.D.H.); Department of Medicine, University of Minnesota School of Medicine, Minneapolis (J.H.T., G.R.); Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA (T.D.H.); Department of Medicine, College of Medicine, University of Florida, Gainesville (C.J.P., J.R.F.); Stem Cell Center (J.T.W., E.C.P.), and Regenerative Medicine Research (D.A.T.), Texas Heart Institute, CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston; Franciscan Saint Francis Health, Indianapolis, IN (A.C.); Department of Cardiovascular Medicine, Stanford University School of Medicine, CA (P.C.Y.); Department of Cardiology, Wake Forest University School of Medicine, Winston-Salem, NC (D.X.M.Z.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, OH (S.G.E.); Summa Health Heart and Vascular Institute, Akron, OH (M.S.P.); Department of Cell and Developmental Biology, Vanderbilt University School of Medicine, Nashville, TN (A.K.H.); Metropolitan Heart and Vascular Institute, Mercy Hospital, Coon Rapids, MN (J.C.C.); United Heart and Vascular Clinic (K.W.B.); Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX (A.P.G.); Coordinating Center for Clinical Trials, UTHealth School of Public Health, Houston, TX (L.M.); National Heart Lung, and Blood Institute, Bethesda, MD (R.F.E.); and University of Kansas School of Medicine (R.D.S.).""}]",Circulation research,['10.1161/CIRCRESAHA.117.311466']
773,29174695,Use of oral cholera vaccine as a vaccine probe to define the geographical dimensions of person-to-person transmission of cholera.,"BACKGROUND


Cholera is known to be transmitted from person to person, and inactivated oral cholera vaccines (OCVs) have been shown to confer herd protection via interruption of this transmission. However, the geographic dimensions of chains of person-to-person transmission of cholera are uncertain. The ability of OCVs to confer herd protection was used to define these dimensions in two cholera-endemic settings, one in rural Bangladesh and the other in urban India.
METHODS


Two large randomized, placebo-controlled trials of inactivated OCVs, one in rural Matlab, Bangladesh and the other in urban Kolkata, India, were reanalyzed. Vaccine herd protection was evaluated by relating the risk of cholera in placebo recipients to vaccine coverage of surrounding residents residing within concentric rings. In Matlab, concentric rings in 100-m increments up to 700m were evaluated; in Kolkata, 50-m increments up to 350m were evaluated.
RESULTS


One hundred and eight cholera cases among 24667 placebo recipients were detected during 1year of post-vaccination follow-up at Matlab; 128 cholera cases among 34968 placebo recipients were detected during 3 years of follow-up in Kolkata. Consistent inverse relationships were observed between vaccine coverage of the ring and the risk of cholera in the central placebo recipient for rings with radii up to 500m in Matlab and up to 150m in Kolkata.
CONCLUSIONS


These results suggest that the dimensions of chains of person-to-person transmission in endemic settings can be quite large and may differ substantially from setting to setting. Using OCVs as 'probes' to define these dimensions can inform geographical targeting strategies for the deployment of these vaccines in endemic settings.",2018,One hundred and eight cholera cases among 24667 placebo recipients were detected during 1year of post-vaccination follow-up at Matlab; 128 cholera cases among 34968 placebo recipients were detected during 3 years of follow-up in Kolkata.,"['rural Matlab, Bangladesh and the other in urban Kolkata, India, were reanalyzed', 'person-to-person transmission of cholera']","['inactivated OCVs', 'oral cholera vaccine', 'placebo']",[],"[{'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C1444005', 'cui_str': 'Person to person transmission'}, {'cui': 'C0008354', 'cui_str': 'Vibrio cholerae Infection'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0008359', 'cui_str': 'Cholera Vaccine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.153794,One hundred and eight cholera cases among 24667 placebo recipients were detected during 1year of post-vaccination follow-up at Matlab; 128 cholera cases among 34968 placebo recipients were detected during 3 years of follow-up in Kolkata.,"[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ali', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Deok Ryun', 'Initials': 'DR', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Kanungo', 'Affiliation': 'National Institute of Cholera and Enteric Diseases, Kolkata, India.'}, {'ForeName': 'Dipika', 'Initials': 'D', 'LastName': 'Sur', 'Affiliation': 'National Institute of Cholera and Enteric Diseases, Kolkata, India.'}, {'ForeName': 'Byomkesh', 'Initials': 'B', 'LastName': 'Manna', 'Affiliation': 'National Institute of Cholera and Enteric Diseases, Kolkata, India.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Digilio', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Shanta', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'National Institute of Cholera and Enteric Diseases, Kolkata, India.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Marks', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Sujit K', 'Initials': 'SK', 'LastName': 'Bhattacharya', 'Affiliation': 'National Institute of Cholera and Enteric Diseases, Kolkata, India.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Clemens', 'Affiliation': 'icddr,b, Dhaka, Bangladesh; UCLA Fielding School of Public Health, Los Angeles, USA; Korea University School of Medicine, Seoul, Republic of Korea. Electronic address: jclemens@icddrb.org.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2017.11.020']
774,31606753,Vitamin D-fortified cooking oil is an effective way to improve vitamin D status: an institutional efficacy trial.,"PURPOSE


High prevalence of vitamin D deficiency (VDD) justifies a cost-effective and sustainable strategy to combat VDD in the community. This study was undertaken for the first time to evaluate the efficacy of daily consumption of vitamin D fortified sunflower oil with a meal.
METHODS


This single-blind trial was conducted in two separate institutions: one as intervention (D-fortified sunflower oil) group (DO, n 1  = 39) and the other as control (unfortified sunflower oil) group (SO, n 2  = 33). Participants consumed their lunches cooked either with D-fortified or unfortified cooking sunflower oil (500 IU/30 g) for 12 weeks. Dietary, anthropometric and biochemical assessments were done for all participants before and after the intervention.
RESULTS


A total of 65 subjects from both sexes aged 32.5 ± 4 years completed the intervention period. Serum 25(OH)D showed a significant increase in DO and a decrease in SO group (8.8 ± 9.3 vs. - 7.4 ± 6.4 ng/mL, p < 0.001). The rise in serum 25(OH)D in DO group was accompanied by a significant decrease in iPTH (DO: - 10.2 ± 29.4 vs. SO: + 9.2 ± 29.5 pg/mL; p = 0.009). A significant reduction in weight (p = 0.004), BMI (p = 0.029), waist girth (p < 0.001), serum total cholesterol (p = 0.0290) and LDL-C (p = 0.010) was observed in DO, as compared with SO group.
CONCLUSIONS


Cooking oil can be considered as an efficacious vehicle for mass fortification program to combat VDD. The improvement of vitamin D status may bring about betterment of certain cardiometabolic risk factors.
REGISTRATION NUMBER


Clinicaltrials.gov: NCT03826654.",2020,"A significant reduction in weight (p = 0.004), BMI (p = 0.029), waist girth (p < 0.001), serum total cholesterol (p = 0.0290) and LDL-C (p = 0.010) was observed in DO, as compared with SO group.
",['65 subjects from both sexes aged 32.5\u2009±\u20094\xa0years completed the intervention period'],"['vitamin D deficiency', 'unfortified cooking sunflower oil', 'intervention (D-fortified sunflower oil) group (DO, n 1 \u2009=\u200939) and the other as control (unfortified sunflower oil', 'Vitamin D-fortified cooking oil', 'vitamin D fortified sunflower oil with a meal', 'Cooking oil']","['serum total cholesterol', 'BMI', 'rise in serum 25(OH)D', 'iPTH', 'vitamin D status', 'waist girth', 'weight', 'DO']","[{'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517710', 'cui_str': '32.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C1306756', 'cui_str': 'Cook (occupation)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0047008', 'cui_str': 'IPTHS'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",65.0,0.147568,"A significant reduction in weight (p = 0.004), BMI (p = 0.029), waist girth (p < 0.001), serum total cholesterol (p = 0.0290) and LDL-C (p = 0.010) was observed in DO, as compared with SO group.
","[{'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Nikooyeh', 'Affiliation': 'Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute and Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azizollaah', 'Initials': 'A', 'LastName': 'Zargaraan', 'Affiliation': 'Department of Food and Nutrition Policy and Planning Research, National Nutrition and Food Technology Research Institute and Faculty of Nutrition and Food Science, Shahid Beheshti University of Medical Sciences and Health Services, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Kalayi', 'Affiliation': 'Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute and Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nastaran', 'Initials': 'N', 'LastName': 'Shariatzadeh', 'Affiliation': 'Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute and Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maliheh', 'Initials': 'M', 'LastName': 'Zahedirad', 'Affiliation': 'Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute and Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Jamali', 'Affiliation': 'Laboratory of Quality Control, Kourosh Food Industry, Tehran, Iran.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Khazraie', 'Affiliation': 'Quality Assurance Unit, Kourosh Food Industry, Tehran, Iran.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Hollis', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Tirang R', 'Initials': 'TR', 'LastName': 'Neyestani', 'Affiliation': 'Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute and Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran. tneyestani@sbmu.ac.ir.'}]",European journal of nutrition,['10.1007/s00394-019-02103-4']
775,31605198,Efficacy of an intermittent energy restriction diet in a primary care setting.,"PURPOSE


Intermittent energy restriction (IER) is a popular weight loss (WL) strategy; however, its efficacy in clinical practice remains unknown. The present study compared the effects of IER compared to continuous energy restriction (CER) on WL and cardiometabolic risk factors in primary care.
METHODS


A (self-selected) cohort study was conducted at the Rotherham Institute for Obesity (RIO), a primary care-based weight management service. 197(24% male) obese patients volunteered to participate and selected their diet group. IER participants (n = 99) consumed ~ 2600 kJ for two days/week. CER participants (n = 98) restricted their diet by ~ 2100 kJ/day below estimated requirements. Both interventions were delivered alongside RIO standard care. Changes in anthropometry and cardiometabolic disease risk markers (fasting biochemistry and blood pressure) were assessed after a 6-month intervention period and then participants were followed up again 6 months later (month 12).
RESULTS


27 IER patients (27%) and 39 CER patients (40%) completed the 6-month weight loss phase. Among completers, mean (SEM) WL was greater in the IER group at 6 months (5.4 ± 1.1% versus 2.8 ± 0.6%; p = 0.01), as were reductions in fat mass (p < 0.001) and improvements in systolic blood pressure (p < 0.001). Fasting insulin (p = 0.873) and diastolic blood pressure (p = 0.701) were reduced similarly in both groups. However, in the IER group, changes in anthropometry and blood pressure in the IER group had reverted to baseline by 12-month follow-up, whilst the CER group maintained weight loss but showed an increase in blood pressure.
CONCLUSIONS


Among completers, IER resulted in superior short-term changes in anthropometry and some cardiometabolic risk factors. However, rates of attrition and weight regain were higher compared with standard care, providing important insights in the implementations of IER within a ""real-life"" NHS setting.
TRIAL REGISTRATION NUMBER


ISRCTN31465600.",2020,"Among completers, IER resulted in superior short-term changes in anthropometry and some cardiometabolic risk factors.","['197(24% male) obese patients volunteered to participate and selected their diet group', 'A (self-selected) cohort study was conducted at the Rotherham Institute for Obesity (RIO), a primary care-based weight management service', 'IER participants (n\u2009=\u200999) consumed\u2009']","['intermittent energy restriction diet', 'continuous energy restriction (CER', 'IER', 'Intermittent energy restriction (IER', 'CER']","['IER resulted in superior short-term changes in anthropometry and some cardiometabolic risk factors', 'systolic blood pressure', 'fat mass', 'blood pressure', 'diastolic blood pressure', 'rates of attrition and weight regain', 'anthropometry and cardiometabolic disease risk markers (fasting biochemistry and blood pressure', 'mean (SEM) WL', 'weight loss', 'anthropometry and blood pressure', 'Fasting insulin', 'WL and cardiometabolic risk factors', '6-month weight loss phase']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0237504', 'cui_str': 'CER (body structure)'}]","[{'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]",,0.024206,"Among completers, IER resulted in superior short-term changes in anthropometry and some cardiometabolic risk factors.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Antoni', 'Affiliation': 'Nutritional Sciences, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Johnston', 'Affiliation': 'Lighterlife UK Ltd, Cavendish House, Parkway, Harlow Business Park, Essex, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Steele', 'Affiliation': 'Clifton Medical Centre, The Health Village, Rotherham Institute for Obesity, Doncaster Gate, Rotherham, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Carter', 'Affiliation': 'Clifton Medical Centre, The Health Village, Rotherham Institute for Obesity, Doncaster Gate, Rotherham, UK.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Robertson', 'Affiliation': 'Nutritional Sciences, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Capehorn', 'Affiliation': 'Clifton Medical Centre, The Health Village, Rotherham Institute for Obesity, Doncaster Gate, Rotherham, UK. mcapehorn@yahoo.co.uk.'}]",European journal of nutrition,['10.1007/s00394-019-02098-y']
776,31601539,"Update from TASCI, a Nationwide, Randomized, Sham-controlled, Double-blind Clinical Trial on Transcutaneous Tibial Nerve Stimulation in Patients with Acute Spinal Cord Injury to Prevent Neurogenic Detrusor Overactivity.","Transcutaneous tibial nerve stimulation has the potential to revolutionize the management of lower urinary tract dysfunction in patients with acute spinal cord injury. TASCI is a nationwide randomized, sham-controlled, double-blind clinical trial for which the preparatory phase has been successfully completed.",2020,Transcutaneous tibial nerve stimulation has the potential to revolutionize the management of lower urinary tract dysfunction in patients with acute spinal cord injury.,"['patients with acute spinal cord injury', 'Patients with Acute Spinal Cord Injury to Prevent Neurogenic Detrusor Overactivity']","['Transcutaneous Tibial Nerve Stimulation', 'Transcutaneous tibial nerve stimulation', 'TASCI']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C1536696', 'cui_str': 'Overactivity'}]","[{'cui': 'C0040186', 'cui_str': 'Tibial Nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]",[],,0.372834,Transcutaneous tibial nerve stimulation has the potential to revolutionize the management of lower urinary tract dysfunction in patients with acute spinal cord injury.,"[{'ForeName': 'Martina D', 'Initials': 'MD', 'LastName': 'Liechti', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'van der Lely', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Stalder', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Collene E', 'Initials': 'CE', 'LastName': 'Anderson', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland; Department of Health Sciences and Medicine, University of Lucerne, Lucerne, Switzerland; Swiss Paraplegic Research, Nottwil, Switzerland.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Birkhäuser', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Lucas M', 'Initials': 'LM', 'LastName': 'Bachmann', 'Affiliation': 'Medignition Inc. Research Consultants, Zürich, Switzerland.'}, {'ForeName': 'Martin W G', 'Initials': 'MWG', 'LastName': 'Brinkhof', 'Affiliation': 'Department of Health Sciences and Medicine, University of Lucerne, Lucerne, Switzerland; Swiss Paraplegic Research, Nottwil, Switzerland.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Curt', 'Affiliation': 'Neurology, Spinal Cord Injury Center, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Jordan', 'Affiliation': 'Clinique Romande de Réadaptation, Sion, Switzerland.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Leitner', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Mehnert', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Möhr', 'Affiliation': 'Neuro-Urology, REHAB Basel, Basel, Switzerland.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Pannek', 'Affiliation': 'Neuro-Urology, Swiss Paraplegic Center, Nottwil, Switzerland; Department of Urology, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schubert', 'Affiliation': 'Neurology, Spinal Cord Injury Center, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Kessler', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland. Electronic address: tkessler@gmx.ch.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology focus,['10.1016/j.euf.2019.09.019']
777,31603245,Oral hygiene revisited. The clinical effect of a prolonged oral hygiene phase prior to periodontal therapy in periodontitis patients. A randomized clinical study.,"AIM


The aim of the present study was to investigate the effect of a 3-month strict oral hygiene phase on key parameters of periodontitis: plaque, bleeding on probing (BOP) and probing pocket depth (PPD).
MATERIALS AND METHODS


Forty-four patients with severe periodontal disease were randomly allocated to a test or a control group. The test group completed a 3-month strict oral hygiene phase. The control group did not receive any instructions or motivation on oral hygiene until after the 3-month period. Plaque, BOP and PPDs were registered on four sites of each tooth at baseline and after 3 months in both groups, as well as after the postponed hygiene phase in the control group.
RESULTS


A statistically significant and profound reduction in plaque, BOP and PPD was observed after the 3 months in the test group. No change to the better occurred in the control group.
CONCLUSION


A 3-month strict oral hygiene phase in patients referred for periodontal therapy reduced plaque, BOP and pocket depth to such an extent that it could affect therapy planning.",2020,"RESULTS


A statistically significant and profound reduction of plaque, bleeding on probing and probing pocket depth was observed after the three months in the test group.","['periodontitis patients', 'Forty-four patients with severe periodontal disease']",[],"['periodontitis: plaque, bleeding on probing and probing pocket depth', 'plaque, bleeding on probing and probing pocket depth', 'Plaque, bleeding on probing and probing pocket depths']","[{'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0031090', 'cui_str': 'Parodontosis'}]",[],"[{'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}]",44.0,0.0286475,"RESULTS


A statistically significant and profound reduction of plaque, bleeding on probing and probing pocket depth was observed after the three months in the test group.","[{'ForeName': 'Hans R', 'Initials': 'HR', 'LastName': 'Preus', 'Affiliation': 'Department of Periodontology, Institute of Clinical Odontology, Faculty of Dentistry, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Qamar', 'Initials': 'Q', 'LastName': 'Al-Lami', 'Affiliation': 'Department of Periodontology, Institute of Clinical Odontology, Faculty of Dentistry, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Baelum', 'Affiliation': 'Department of Dentistry Health, Aarhus University, Aarhus, Denmark.'}]",Journal of clinical periodontology,['10.1111/jcpe.13207']
778,31605197,"The effect of inulin and resistant maltodextrin on weight loss during energy restriction: a randomised, placebo-controlled, double-blinded intervention.","PURPOSE


The objective of this study was to investigate the additive effects of combining energy restriction with dietary fibres on change in body weight and gut microbiota composition.
METHODS


The study was a 12-week randomised, placebo-controlled, double-blinded, parallel intervention trial. A total of 116 overweight or obese participants were assigned randomly either to 10 g inulin plus 10 g resistant maltodextrin or to 20 g of placebo supplementation through 400 mL of milk a day, while on a - 500 kcal/day energy restricted diet.
RESULTS


Altogether, 86 participants completed the intervention. There were no significant differences in weight loss or body composition between the groups. The fibre supplement reduced systolic (5.35 ± 2.4 mmHg, p = 0.043) and diastolic (2.82 ± 1.3 mmHg, p = 0.047) blood pressure to a larger extent than placebo. Furthermore, a larger decrease in serum insulin was observed in the placebo group compared to the fibre group (- 26.0 ± 9.2 pmol/L, p = 0.006). The intake of fibre induced changes in the composition of gut microbiota resulting in higher abundances of Parabacteroides and Bifidobacteria, compared to placebo. The effects on blood pressure and glucose metabolism were mainly observed in women, and could be attributed to a higher gut microbiota diversity after intervention. Finally, the fibre group experienced a higher degree of gastrointestinal symptoms, which attenuated over time.
CONCLUSIONS


Supplementation of inulin and resistant maltodextrin did not provide an additional weight loss during an energy-restricted diet, but reduced both systolic and diastolic blood pressure. Furthermore, the fibre supplement did stimulate the growth of potentially beneficial bacteria genera.
CLINICAL TRIAL REGISTRY


The study was registered at http://www.clinicaltrials.gov , NCT03135041.",2020,"The fibre supplement reduced systolic (5.35 ± 2.4 mmHg, p = 0.043) and diastolic (2.82 ± 1.3 mmHg, p = 0.047) blood pressure to a larger extent than placebo.","['116 overweight or obese participants', '86 participants completed the intervention']","['placebo', 'inulin plus 10\xa0g resistant maltodextrin or to 20\xa0g of placebo supplementation through 400\xa0mL of milk a day, while on a -\u2009500\xa0kcal/day energy restricted diet', 'inulin and resistant maltodextrin']","['gastrointestinal symptoms', 'blood pressure', 'diastolic', 'body weight and gut microbiota composition', 'serum insulin', 'blood pressure and glucose metabolism', 'weight loss', 'weight loss or body composition', 'systolic and diastolic blood pressure', 'additional weight loss']","[{'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0450403', 'cui_str': '20G (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0456649', 'cui_str': 'kcal/day'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}]",86.0,0.439913,"The fibre supplement reduced systolic (5.35 ± 2.4 mmHg, p = 0.043) and diastolic (2.82 ± 1.3 mmHg, p = 0.047) blood pressure to a larger extent than placebo.","[{'ForeName': 'Anne Lundby', 'Initials': 'AL', 'LastName': 'Hess', 'Affiliation': 'The Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Rolighedsvej 26, 1958, Frederiksberg C, Denmark. lundbyhess@gmail.com.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Benítez-Páez', 'Affiliation': 'Microbial Ecology, Nutrition and Health Research Unit, Institute of Agrochemistry and Food Technology, Spanish National Research Council IATA-CSIC, C/Catedràtic Agustín Escardino Benlloch, 7, 46980, Paterna-Valencia, Spain. abenitez@iata.csic.es.'}, {'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Blædel', 'Affiliation': 'The Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Rolighedsvej 26, 1958, Frederiksberg C, Denmark.'}, {'ForeName': 'Lesli Hingstrup', 'Initials': 'LH', 'LastName': 'Larsen', 'Affiliation': 'The Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Rolighedsvej 26, 1958, Frederiksberg C, Denmark.'}, {'ForeName': 'Jose Ramón', 'Initials': 'JR', 'LastName': 'Iglesias', 'Affiliation': 'Corporación Alimentaria Peñasanta S.A., Asturias, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Madera', 'Affiliation': 'Corporación Alimentaria Peñasanta S.A., Asturias, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Sanz', 'Affiliation': 'Microbial Ecology, Nutrition and Health Research Unit, Institute of Agrochemistry and Food Technology, Spanish National Research Council IATA-CSIC, C/Catedràtic Agustín Escardino Benlloch, 7, 46980, Paterna-Valencia, Spain.'}, {'ForeName': 'Thomas Meinert', 'Initials': 'TM', 'LastName': 'Larsen', 'Affiliation': 'The Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Rolighedsvej 26, 1958, Frederiksberg C, Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of nutrition,['10.1007/s00394-019-02099-x']
779,29148822,The Long-Term Efficacy of a Galactagogue Containing Sylimarin-Phosphatidylserine and Galega on Milk Production of Mothers of Preterm Infants.,"AIMS


To investigate the efficacy of a galactagogue, containing Sylimarin-phosphatidylserine (SILITIDIL) and galega consumed in the first month after delivery by mothers of preterm infants, in maintaining milk production during the first 3-6 months after delivery.
MATERIALS AND METHODS


Mothers of infants born at gestational age (GA) between 27 and 32 weeks, enrolled in our previous prospective, double-blind, randomized trial and randomly allocated to receive either the galactagogue (GG) or a placebo (PG), were asked about their milk production at 3 and 6 months after delivery.
RESULTS


Of the 100 mothers involved in this study, 45 of GG and 44 of PG responded comprehensively to the questions asked. At the third month after delivery, exclusive human milk administration was reported by 22 mothers of GG and 12 mothers of PG (p < 0.05), whereas 29 mothers of GG and 18 mothers of PG were able to administer >50% of the amount of milk assumed. At the sixth month of life, only eight infants received exclusive human milk (six and two of GG and PG, respectively), and the data are not sufficient for a meaningful clinical evaluation.
CONCLUSIONS


It is assumed that a galactagogue during the first month after delivery improves human milk administration to preterm neonates after discharge and for the first 3 months of life.",2018,"At the third month after delivery, exclusive human milk administration was reported by 22 mothers of GG and 12 mothers of PG (p < 0.05), whereas 29 mothers of GG and 18 mothers of PG were able to administer >50% of the amount of milk assumed.","['Mothers of infants born at gestational age (GA) between 27 and 32 weeks', 'Mothers of Preterm Infants', 'mothers of preterm infants', '100 mothers']","['exclusive human milk', 'Galactagogue Containing Sylimarin-Phosphatidylserine and Galega', 'galactagogue, containing Sylimarin-phosphatidylserine (SILITIDIL) and galega', 'galactagogue (GG) or a placebo (PG']",[],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C2717873', 'cui_str': 'Galactagogues'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0031623', 'cui_str': 'Phosphatidyl Serines'}, {'cui': 'C0330826', 'cui_str': 'Galega'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.10311,"At the third month after delivery, exclusive human milk administration was reported by 22 mothers of GG and 12 mothers of PG (p < 0.05), whereas 29 mothers of GG and 18 mothers of PG were able to administer >50% of the amount of milk assumed.","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Serrao', 'Affiliation': 'Division of Neonatology, Department of Woman and Child Health, Catholic University of the Sacred Heart , Rome, Italy .'}, {'ForeName': 'Mirta', 'Initials': 'M', 'LastName': 'Corsello', 'Affiliation': 'Division of Neonatology, Department of Woman and Child Health, Catholic University of the Sacred Heart , Rome, Italy .'}, {'ForeName': 'Costantino', 'Initials': 'C', 'LastName': 'Romagnoli', 'Affiliation': 'Division of Neonatology, Department of Woman and Child Health, Catholic University of the Sacred Heart , Rome, Italy .'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': ""D'Andrea"", 'Affiliation': 'Division of Neonatology, Department of Woman and Child Health, Catholic University of the Sacred Heart , Rome, Italy .'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Zecca', 'Affiliation': 'Division of Neonatology, Department of Woman and Child Health, Catholic University of the Sacred Heart , Rome, Italy .'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2017.0169']
780,27852348,An adaptive randomized trial of dialectical behavior therapy and cognitive behavior therapy for binge-eating.,"BACKGROUND


Early weak treatment response is one of the few trans-diagnostic, treatment-agnostic predictors of poor outcome following a full treatment course. We sought to improve the outcome of clients with weak initial response to guided self-help cognitive behavior therapy (GSH).
METHOD


One hundred and nine women with binge-eating disorder (BED) or bulimia nervosa (BN) (DSM-IV-TR) received 4 weeks of GSH. Based on their response, they were grouped into: (1) early strong responders who continued GSH (cGSH), and early weak responders randomized to (2) dialectical behavior therapy (DBT), or (3) individual and additional group cognitive behavior therapy (CBT+).
RESULTS


Baseline objective binge-eating-day (OBD) frequency was similar between DBT, CBT+ and cGSH. During treatment, OBD frequency reduction was significantly slower in DBT and CBT+ relative to cGSH. Relative to cGSH, OBD frequency was significantly greater at the end of DBT (d = 0.27) and CBT+ (d = 0.31) although these effects were small and within-treatment effects from baseline were large (d = 1.41, 0.95, 1.11, respectively). OBD improvements significantly diminished in all groups during 12 months follow-up but were significantly better sustained in DBT relative to cGSH (d = -0.43). At 6- and 12-month follow-up assessments, DBT, CBT and cGSH did not differ in OBD.
CONCLUSIONS


Early weak response to GSH may be overcome by additional intensive treatment. Evidence was insufficient to support superiority of either DBT or CBT+ for early weak responders relative to early strong responders in cGSH; both were helpful. Future studies using adaptive designs are needed to assess the use of early response to efficiently deliver care to large heterogeneous client groups.",2017,Evidence was insufficient to support superiority of either DBT or CBT+ for early weak responders relative to early strong responders in cGSH; both were helpful.,"['One hundred and nine women with binge-eating disorder (BED) or bulimia nervosa (BN) (DSM-IV-TR', 'binge-eating']","['continued GSH (cGSH', 'dialectical behavior therapy and cognitive behavior therapy', 'dialectical behavior therapy (DBT), or (3) individual and additional group cognitive behavior therapy (CBT', 'GSH', 'guided self-help cognitive behavior therapy (GSH', 'DBT or CBT']","['OBD improvements', 'OBD frequency reduction', 'Baseline objective binge-eating-day (OBD) frequency', 'OBD frequency']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C2267227', 'cui_str': 'Bulimia Nervosa'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}]","[{'cui': 'C1321145', 'cui_str': 'Dialectical Behavior Therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",109.0,0.0379512,Evidence was insufficient to support superiority of either DBT or CBT+ for early weak responders relative to early strong responders in cGSH; both were helpful.,"[{'ForeName': 'E Y', 'Initials': 'EY', 'LastName': 'Chen', 'Affiliation': 'Department of Psychology,Temple University,Philadelphia, PA,USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cacioppo', 'Affiliation': 'Department of Psychology,The University of Chicago,Chicago, IL,USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Fettich', 'Affiliation': 'Department of Psychology,Temple University,Philadelphia, PA,USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gallop', 'Affiliation': 'Department of Mathematics,West Chester University,West Chester, PA,USA.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'McCloskey', 'Affiliation': 'Department of Psychology,Temple University,Philadelphia, PA,USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Olino', 'Affiliation': 'Department of Psychology,Temple University,Philadelphia, PA,USA.'}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Zeffiro', 'Affiliation': 'Neurometrika,Potomac, MD,USA.'}]",Psychological medicine,['10.1017/S0033291716002543']
781,28756115,The effects of Lactobacillus reuteri probiotics combined with azithromycin on peri-implantitis: A randomized placebo-controlled study.,"PURPOSE


The aim of this randomized placebo-controlled clinical study was to investigate the effects of a probiotic tablet containing Lactobacillus reuteri in peri-implantitis patients.
METHODS


Subjects comprised 30 patients with mild to moderate peri-implantitis. A baseline clinical examination and microbiological assessment were conducted, followed by an antibiotics treatment (azithromycin, 500mg, once a day for 3 days). Subjects were divided into probiotic and placebo groups. The clinical examination and bacterial sampling were performed 0, 4, 12 and 24 weeks after the intake of probiotics. The clinical examination included probing pocket depth (PPD), bleeding on probing (BOP), the modified plaque index (mPI), and modified bleeding index (mBI). The number of bacteria was assessed using the PCR-invader method. The Wilcoxon rank-sum test and Wilcoxon signed-rank test with Bonferroni corrections were used for data analyses.
RESULTS


Although the number of bacteria decreased after the administration of azithromycin in both groups, they increased again thereafter. No significant difference was observed in bacterial numbers between the two groups. Although PPD in the probiotics group was significantly lower at 4 and 24 weeks than at 0 weeks (p<0.05), a significant decrease did not occur in the placebo group. The mBI score at 24 weeks was significantly lower in the probiotics group than in the placebo group (p<0.05). No significant difference was observed in BOP or mPI between the two groups.
CONCLUSION


These results suggested that probiotics prevent inflammation by affecting host responses rather than improving microbial flora in peri-implant sulci in peri-implantitis patients.",2018,The mBI score at 24 weeks was significantly lower in the probiotics group than in the placebo group (p<0.05).,"['peri-implantitis patients', 'Subjects comprised 30 patients with mild to moderate peri-implantitis']","['placebo', 'Lactobacillus reuteri probiotics combined with azithromycin', 'azithromycin', 'probiotic and placebo', 'probiotic tablet containing Lactobacillus reuteri', 'antibiotics treatment (azithromycin']","['bacterial numbers', 'BOP or mPI', 'peri-implantitis', 'number of bacteria', 'probing pocket depth (PPD), bleeding on probing (BOP), the modified plaque index (mPI), and modified bleeding index (mBI', 'mBI score']","[{'cui': 'C2936258', 'cui_str': 'Periimplantitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2936258', 'cui_str': 'Periimplantitis'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",30.0,0.0533346,The mBI score at 24 weeks was significantly lower in the probiotics group than in the placebo group (p<0.05).,"[{'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Tada', 'Affiliation': 'Department of Oral Reconstruction and Rehabilitation, Kyushu Dental University, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Masaki', 'Affiliation': 'Department of Oral Reconstruction and Rehabilitation, Kyushu Dental University, Japan. Electronic address: masaki@kyu-dent.ac.jp.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Tsuka', 'Affiliation': 'Department of Oral Reconstruction and Rehabilitation, Kyushu Dental University, Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Mukaibo', 'Affiliation': 'Department of Oral Reconstruction and Rehabilitation, Kyushu Dental University, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Kondo', 'Affiliation': 'Department of Oral Reconstruction and Rehabilitation, Kyushu Dental University, Japan.'}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Hosokawa', 'Affiliation': 'Department of Oral Reconstruction and Rehabilitation, Kyushu Dental University, Japan.'}]",Journal of prosthodontic research,['10.1016/j.jpor.2017.06.006']
782,31546105,Healthy learning mind - Effectiveness of a mindfulness program on mental health compared to a relaxation program and teaching as usual in schools: A cluster-randomised controlled trial.,"BACKGROUND


Mindfulness-Based Interventions (MBIs) have shown promising effects on mental health among children and adolescents, but high-quality studies examining the topic are lacking. The present study assessed the effects of MBI on mental health in school-setting in an extensive randomised controlled trial.
METHODS


Finnish school children and adolescents (N = 3519), aged 12-15 years (6th to 8th graders), from 56 schools were randomized into a 9 week MBI group, and control groups with a relaxation program or teaching as usual. The primary outcomes were resilience, socio-emotional functioning, and depressive symptoms at baseline, at completion of the programs at 9 weeks (T9), and at follow-up at 26 weeks (T26).
RESULTS


Overall, mindfulness did not show more beneficial effects on the primary outcomes compared to the controls except for resilience for which a positive intervention effect was found at T9 in all participants (β=1.18, SE 0.57, p = 0.04) as compared to the relaxation group. In addition, in gender and grade related analyses, MBI lowered depressive symptoms in girls at T26 (β=-0.49, SE 0.21, p = 0.02) and improved socio-emotional functioning at T9 (β=-1.37, SE 0.69, p = 0.049) and at T26 (β=-1.71, SE 0.73, p = 0.02) among 7th graders as compared to relaxation.
LIMITATIONS


The inactive control group was smaller than the intervention and active control groups, reducing statistical power.
CONCLUSIONS


A short 9-week MBI in school-setting provides slight benefits over a relaxation program and teaching as usual. Future research should investigate whether embedding regular mindfulness-based practice in curriculums could intensify the effects.",2020,"Overall, mindfulness did not show more beneficial effects on the primary outcomes compared to the controls except for resilience for which a positive intervention effect was found at T9 in all participants (β=1.18, SE 0.57, p = 0.04) as compared to the relaxation group.","['Finnish school children and adolescents (N\u202f=\u202f3519), aged 12-15 years (6th to 8th graders), from 56 schools', 'children and adolescents']","['mindfulness program', 'relaxation program or teaching as usual', 'Mindfulness-Based Interventions (MBIs', 'relaxation program and teaching', 'MBI']","['resilience, socio-emotional functioning, and depressive symptoms', 'MBI lowered depressive symptoms', 'mental health', 'socio-emotional functioning']","[{'cui': 'C0260267', 'cui_str': 'School child (occupation)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0475668', 'cui_str': 'Relaxation program (regime/therapy)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.0687393,"Overall, mindfulness did not show more beneficial effects on the primary outcomes compared to the controls except for resilience for which a positive intervention effect was found at T9 in all participants (β=1.18, SE 0.57, p = 0.04) as compared to the relaxation group.","[{'ForeName': 'S-M', 'Initials': 'SM', 'LastName': 'Volanen', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland; Clinicum, Department of Public Health, University of Helsinki, Finland. Electronic address: salla-maarit.volanen@helsinki.fi.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lassander', 'Affiliation': 'Institute of Behavioural Sciences, University of Helsinki Finland.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Hankonen', 'Affiliation': 'Social Psychology Unit, Faculty of Social Sciences, University of Helsinki, Finland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Santalahti', 'Affiliation': 'National Institute for Health and Welfare, Finland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hintsanen', 'Affiliation': 'Unit of Psychology, University of Oulu, Oulu, Finland.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Simonsen', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland; Clinicum, Department of Public Health, University of Helsinki, Finland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Raevuori', 'Affiliation': 'Clinicum, Department of Public Health, University of Helsinki, Finland; Department of Adolescent Psychiatry, Helsinki University Central Hospital, Helsinki, Finland; Department of Mental Health and Substance Abuse Services, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mullola', 'Affiliation': 'Institute of Behavioural Sciences, University of Helsinki Finland; Department of Teacher Education, University of Helsinki, Finland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Vahlberg', 'Affiliation': 'Department of Biostatistics, University of Turku, Finland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'But', 'Affiliation': 'Clinicum, Department of Public Health, University of Helsinki, Finland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Suominen', 'Affiliation': 'Department of Public Health, University of Skövde, Sweden; Department of Public Health, University of Turku, Finland.'}]",Journal of affective disorders,['10.1016/j.jad.2019.08.087']
783,28592386,"CT-P6 compared with reference trastuzumab for HER2-positive breast cancer: a randomised, double-blind, active-controlled, phase 3 equivalence trial.","BACKGROUND


CT-P6 is a proposed biosimilar to reference trastuzumab. In this study, we aimed to establish equivalence of CT-P6 to reference trastuzumab in neoadjuvant treatment of HER2-positive early-stage breast cancer.
METHODS


In this randomised, double-blind, active-controlled, phase 3 equivalence trial, we recruited women aged 18 years or older with stage I-IIIa operable HER2-positive breast cancer from 112 centres in 23 countries. Inclusion criteria were an Eastern Cooperative Oncology Group performance status score of 0 or 1; a normal left ventricular ejection fraction of at least 55%; adequate bone marrow, hepatic, and renal function; at least one measureable lesion; and known oestrogen and progesterone receptor status. Exclusion criteria included bilateral breast cancer, previous breast cancer treatment, previous anthracycline treatment, and pregnancy or lactation. We randomly allocated patients 1:1 to receive neoadjuvant CT-P6 or reference trastuzumab intravenously (eight cycles, each lasting 3 weeks, for 24 weeks; 8 mg/kg on day 1 of cycle 1 and 6 mg/kg on day 1 of cycles 2-8) in conjunction with neoadjuvant docetaxel (75 mg/m 2  on day 1 of cycles 1-4) and FEC (fluorouracil [500 mg/m 2 ], epirubicin [75 mg/m 2 ], and cyclophosphamide [500 mg/m 2 ]; day 1 of cycles 5-8) therapy. We stratified randomisation by clinical stage, receptor status, and country and used permuted blocks. We did surgery within 3-6 weeks of the final neoadjuvant study drug dose, followed by an adjuvant treatment period of up to 1 year. We monitored long-term safety and efficacy for 3 years after the last patient was enrolled. Participants and investigators were masked to treatment until study completion. The primary efficacy endpoint, analysed in the per-protocol population, was pathological complete response, assessed via specimens obtained during surgery, analysed by masked central review of local histopathology reports. The equivalence margin was -0·15 to 0·15. This trial is registered with ClinicalTrials.gov, number NCT02162667, and is ongoing, but no longer recruiting.
FINDINGS


Between Aug 7, 2014, and May 6, 2016, we randomly allocated 549 patients (271 [49%] to CT-P6 vs 278 [51%] to reference trastuzumab). A similar proportion of patients achieved pathological complete response with CT-P6 (116 [46·8%; 95% CI 40·4-53·2] of 248 patients) and reference trastuzumab (129 [50·4%; 44·1-56·7] of 256 patients). The 95% CI of the estimated treatment outcome difference (-0·04% [95% CI -0·12 to 0·05]) was within the equivalence margin. 19 (7%) of 271 patients in the CT-P6 group reported serious treatment-emergent adverse events versus 22 (8%) of 278 in the reference trastuzumab group; frequent (occurring in more than one patient) serious adverse events were febrile neutropenia (four [1%] vs one [<1%]) and neutropenia (one [<1%] vs two [1%]). Grade 3 or worse treatment-related adverse events occurred in 17 (6%) of 271 patients in the CT-P6 group versus 23 (8%) of 278 in the reference trastuzumab group; the most frequently reported adverse event was neutropenia in ten (4%) versus 14 (5%).
INTERPRETATION


CT-P6 showed equivalent efficacy to reference trastuzumab and adverse events were similar. Availability of trastuzumab biosimilars could increase access to this targeted therapy for HER2-positive early-stage cancer.
FUNDING


Celltrion Inc.",2017,19 (7%) of 271 patients in the CT-P6 group reported serious treatment-emergent adverse events versus 22 (8%) of 278 in the reference trastuzumab group; frequent (occurring in more than one patient) serious adverse events were febrile neutropenia (four [1%] vs one [<1%]) and neutropenia (one [<1%] vs two [1%]).,"['Inclusion criteria were an Eastern Cooperative Oncology Group performance status score of 0 or 1; a normal left ventricular ejection fraction of at least 55%; adequate bone marrow, hepatic, and renal function; at least one measureable lesion; and known oestrogen and progesterone receptor status', 'Exclusion criteria included bilateral breast cancer, previous breast cancer treatment, previous anthracycline treatment, and pregnancy or lactation', 'HER2-positive early-stage breast cancer', 'women aged 18 years or older with stage I-IIIa operable HER2-positive breast cancer from 112 centres in 23 countries', 'Between Aug 7, 2014, and May 6, 2016', 'HER2-positive breast cancer']","['FEC (fluorouracil [500 mg/m 2 ], epirubicin', 'CT-P6 compared with reference trastuzumab', 'CT-P6 to reference trastuzumab', 'cyclophosphamide', 'trastuzumab biosimilars', 'neoadjuvant CT-P6 or reference trastuzumab', 'neoadjuvant docetaxel']","['febrile neutropenia', 'serious treatment-emergent adverse events', 'neutropenia', 'Grade 3 or worse treatment-related adverse events', 'adverse event was neutropenia']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0202006', 'cui_str': 'Estrogen measurement (procedure)'}, {'cui': 'C0034833', 'cui_str': 'Receptors, Progestin'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0222605', 'cui_str': 'Both breasts (body structure)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0022925', 'cui_str': 'Milk Secretion'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0205188', 'cui_str': 'Operable (qualifier value)'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",549.0,0.344453,19 (7%) of 271 patients in the CT-P6 group reported serious treatment-emergent adverse events versus 22 (8%) of 278 in the reference trastuzumab group; frequent (occurring in more than one patient) serious adverse events were febrile neutropenia (four [1%] vs one [<1%]) and neutropenia (one [<1%] vs two [1%]).,"[{'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Stebbing', 'Affiliation': 'Division of Cancer, Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Yauheni', 'Initials': 'Y', 'LastName': 'Baranau', 'Affiliation': 'Chemotherapy Department #1, Minsk City Clinical Oncological Dispensary, Minsk, Belarus.'}, {'ForeName': 'Valeriy', 'Initials': 'V', 'LastName': 'Baryash', 'Affiliation': 'Department of Oncology, Belarusian State Medical University, Minsk, Belarus.'}, {'ForeName': 'Alexey', 'Initials': 'A', 'LastName': 'Manikhas', 'Affiliation': 'Breast Cancer Department, City Clinical Oncology Dispensary, Saint Petersburg, Russia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Moiseyenko', 'Affiliation': 'St Petersburg Clinical Scientific and Practical Centre of Specialized Kinds of Medical Care (Oncologic), Saint Petersburg, Russia.'}, {'ForeName': 'Giorgi', 'Initials': 'G', 'LastName': 'Dzagnidze', 'Affiliation': 'Breast Unit, Khechinashvili University Hospital, Tbilisi, Georgia.'}, {'ForeName': 'Edvard', 'Initials': 'E', 'LastName': 'Zhavrid', 'Affiliation': 'Chemotherapy Department, NN Alexandrov Republican Scientific and Practical Centre of Oncology and Medical Radiology, Minsk, Belarus.'}, {'ForeName': 'Dmytro', 'Initials': 'D', 'LastName': 'Boliukh', 'Affiliation': 'Surgical Department, Vinnytsya Regional Clinical Oncologic Dispensary, Vinnytsya, Ukraine.'}, {'ForeName': 'Daniil', 'Initials': 'D', 'LastName': 'Stroyakovskii', 'Affiliation': 'Moscow City Oncology Hospital #62 of Moscow Healthcare Department, Moscow Oblast, Russia.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Pikiel', 'Affiliation': 'Copernicus Wojewódzkie Centrum Onkologii Gdańsk, Gdańsk, Poland.'}, {'ForeName': 'Alexandru', 'Initials': 'A', 'LastName': 'Eniu', 'Affiliation': 'Department of Breast Tumors, Cancer Institute Ion Chiricuta, Cluj-Napoca, Romania.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Komov', 'Affiliation': 'Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Morar-Bolba', 'Affiliation': 'Department of Breast Tumors, Cancer Institute Ion Chiricuta, Cluj-Napoca, Romania.'}, {'ForeName': 'Rubi K', 'Initials': 'RK', 'LastName': 'Li', 'Affiliation': ""St Luke's Medical Center, Quezon City, Philippines.""}, {'ForeName': 'Andriy', 'Initials': 'A', 'LastName': 'Rusyn', 'Affiliation': 'Transkarpathian Regional Oncology Clinic, Uzhgorod, Ukraine.'}, {'ForeName': 'Sang Joon', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Celltrion Inc, Incheon, South Korea.'}, {'ForeName': 'Sung Young', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Celltrion Inc, Incheon, South Korea.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Esteva', 'Affiliation': 'Laura and Isaac Perlmutter Cancer Center, New York University Langone Medical Center, New York, NY, USA. Electronic address: francisco.esteva@nyumc.org.'}]",The Lancet. Oncology,['10.1016/S1470-2045(17)30434-5']
784,31432716,Single-Use Versus Reusable Digital Flexible Ureteroscopes for the Treatment of Renal Calculi: A Prospective Multicenter Randomized Controlled Trial.,"Objective:  To compare the efficacy and safety of a single-use digital flexible ureteroscope (f-URS) and a reusable digital f-URS (URF-V) for the treatment of renal stones in adults.  Patients and Methods:  In this randomized open-label noninferiority trial, we randomly selected patients with renal stones to receive ureteroscopy through a single-use digital f-URS (ZebraScope ™ ; Happiness Workshop, Beijing, China) or a URF-V (Olympus, Tokyo, Japan). The primary endpoint was the 1-month postsurgical stone-free rate (SFR). The secondary efficacy endpoints assessed were the high-quality rate of images, the eligible rate of operability, the operative time, and the length of hospital stay. The safety outcomes assessed were the presence of postoperative complications, adverse events (AEs), and serious AEs (SAEs). The noninferiority margin was set at -10%.  Results:  In total, 126 patients completed the study (i.e., 63 patients in each group). The demographic and preoperative parameters were comparable between the two groups. The 1-month SFR was 77.78% for the ZebraScope group and 68.25% for the URF-V group (two-sided 95% confidence interval [CI]: -5.95 to 25.01). The high-quality rate of images and the eligible rate of operability were 100% in both groups (two-sided 95% CI: -5.27 to 5.35). There was no difference between the two groups in the operative time ( p  = 0.687), the length of hospital stay ( p  = 0.430), the presence of postoperative complications ( p  = 0.310), the presence of AEs ( p  = 0.709), and the presence of SAEs ( p  = 0.648). The most important and fatal SAE was acute urinary tract obstruction.  Conclusion:  The single-use digital f-URS (ZebraScope) appears to be at least noninferior to URF-V regarding the 1-month SFR, the high-quality rate of images, and the eligible rate of operability. Single-use digital f-URSs are an effective and safe alternative to URF-V.",2020,"There was no difference between the two groups in the operative time (P=0.687), the length of hospital stay (P=0.430), the presence of postoperative complications (P=0.310), the presence of AEs (","['renal calculi', 'renal stones in adults', '126 patients completed the study (i.e., 63 patients in each group', 'randomly selected patients with renal stones to receive']","['ZebraScopeTM', 'single-use digital flexible ureteroscope (f-URS) and a reusable digital f-URS', 'Single-use vs reusable digital flexible ureteroscopes', 'ureteroscopy via a single-use digital f-URS (ZebraScopeTM, Happiness Workshop, Beijing, China) or a reusable digital f-URS (URF-V, Olympus, Tokyo, Japan']","['acute urinary tract obstruction', 'high-quality rate of images, the eligible rate of operability, the operative time and the length of hospital stay', '1-month SFR', 'length of hospital stay', 'presence of AEs ', 'presence of postoperative complications, adverse events (AEs), and serious adverse events (SAEs', 'high-quality rate of images and the eligible rate of operability', '1-month postsurgical stone-free rate (SFR', 'operative time', 'efficacy and safety', 'presence of postoperative complications']","[{'cui': 'C0022650', 'cui_str': 'Kidney Stones'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0392306', 'cui_str': 'Flexible ureteroscope (physical object)'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0040371', 'cui_str': 'Tokyo'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0178879', 'cui_str': 'Urinary tract obstruction (disorder)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1264665', 'cui_str': 'Substance fraction'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",126.0,0.0654336,"There was no difference between the two groups in the operative time (P=0.687), the length of hospital stay (P=0.430), the presence of postoperative complications (P=0.310), the presence of AEs (","[{'ForeName': 'Shiyong', 'Initials': 'S', 'LastName': 'Qi', 'Affiliation': 'Department of Urology, Tianjin Institute of Urology, The Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Enguang', 'Initials': 'E', 'LastName': 'Yang', 'Affiliation': 'Key Laboratory of Gansu Province for Urological Diseases, Gansu Nephro-Urological Clinical Center, Institute of Urology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Junsheng', 'Initials': 'J', 'LastName': 'Bao', 'Affiliation': 'Key Laboratory of Gansu Province for Urological Diseases, Gansu Nephro-Urological Clinical Center, Institute of Urology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Ningqiang', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Key Laboratory of Gansu Province for Urological Diseases, Gansu Nephro-Urological Clinical Center, Institute of Urology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Hongfeng', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Department of Urology, Peking University Shougang Hospital, Beijing, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Peking University Shougang Hospital, Beijing, China.'}, {'ForeName': 'Ningchen', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Peking University Shougang Hospital, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'Department of Urology, Capital Medical University, Beijing Xuanwu Hospital, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Department of Urology, Capital Medical University, Beijing Xuanwu Hospital, Beijing, China.'}, {'ForeName': 'Tongwen', 'Initials': 'T', 'LastName': 'Ou', 'Affiliation': 'Department of Urology, Capital Medical University, Beijing Xuanwu Hospital, Beijing, China.'}, {'ForeName': 'Jiaji', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Gansu Province for Urological Diseases, Gansu Nephro-Urological Clinical Center, Institute of Urology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Gansu Province for Urological Diseases, Gansu Nephro-Urological Clinical Center, Institute of Urology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Yuanjie', 'Initials': 'Y', 'LastName': 'Niu', 'Affiliation': 'Department of Urology, Tianjin Institute of Urology, The Second Hospital of Tianjin Medical University, Tianjin, China.'}]",Journal of endourology,['10.1089/end.2019.0473']
785,31580931,Effects of stress-induced inflammation on reward processing in healthy young women.,"BACKGROUND


Anhedonia, or loss of interest or pleasure, is a feature of depression and transdiagnostic construct in psychopathology. Theory and compelling evidence from preclinical models implicates stress-induced inflammation as a psychobiological pathway to anhedonic behavior; however, this pathway has not been tested in human models. Further, although anhedonia may reflect dysregulation in multiple dimensions of reward, the extent to which stress-induced inflammation alters these dimensions is unclear. Thus, the current experimental study used a standardized laboratory stressor task to elicit an inflammatory response and evaluate effects of stress-induced inflammation on multiple behavioral indices of reward processing.
METHODS


Healthy young women (age 18-25) completed behavioral reward tasks assessing reward learning, motivation, and sensitivity and were randomized to undergo an acute psychosocial stressor (n = 37) or a no-stress active control (n = 17). Tasks were re-administered 90-120 min post-stress to coincide with the peak of the stress-induced inflammatory response. Blood samples were collected for assessment of the pro-inflammatory cytokine interleukin-6 (IL-6) at baseline and 90 and 120 min post stressor.
RESULTS


Stress-induced IL-6 was associated with increased response bias during reward learning and increased motivation when probability of receiving a reward was low. Sensitivity to reward in the context of a motivation task was not altered in association with stress-induced IL-6.
CONCLUSIONS


Contrary to hypotheses, mild increases in IL-6 following acute stress were associated with increased reward responsiveness during reward learning and selective increases in motivation. Results contribute to an emerging and nuanced literature linking inflammation to reward processing, and demonstrate that behavioral effects of stress-induced inflammation may be detected in the laboratory setting.
CLINICAL TRIAL REGISTRATION


NCT03828604.",2020,"RESULTS


Stress-induced IL-6 was associated with increased response bias during reward learning and increased motivation when probability of receiving a reward was low.","['Healthy Young Women', 'Healthy young women (age 18-25) completed']","['Stress-Induced Inflammation', 'behavioral reward tasks assessing reward learning, motivation, and sensitivity and were randomized to undergo an acute psychosocial stressor (n = 37) or a no-stress active control']",['reward responsiveness during reward learning and selective increases in motivation'],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",,0.0614676,"RESULTS


Stress-induced IL-6 was associated with increased response bias during reward learning and increased motivation when probability of receiving a reward was low.","[{'ForeName': 'Chloe C', 'Initials': 'CC', 'LastName': 'Boyle', 'Affiliation': 'Norman Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Behavior, University of California, Los Angeles, CA 90095, United States. Electronic address: ccboyle@ucla.edu.'}, {'ForeName': 'Annette L', 'Initials': 'AL', 'LastName': 'Stanton', 'Affiliation': 'Norman Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Behavior, University of California, Los Angeles, CA 90095, United States; Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, CA 90095, United States; Department of Psychology, University of California, Los Angeles, CA 90095, United States.'}, {'ForeName': 'Naomi I', 'Initials': 'NI', 'LastName': 'Eisenberger', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA 90095, United States.'}, {'ForeName': 'Teresa E', 'Initials': 'TE', 'LastName': 'Seeman', 'Affiliation': 'Geffen School of Medicine, University of California, Los Angeles, CA 90095, United States.'}, {'ForeName': 'Julienne E', 'Initials': 'JE', 'LastName': 'Bower', 'Affiliation': 'Norman Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Behavior, University of California, Los Angeles, CA 90095, United States; Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, CA 90095, United States; Department of Psychology, University of California, Los Angeles, CA 90095, United States.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2019.09.023']
786,32412796,Glucagon-like peptide-1 (GLP-1)-based receptor agonists as a treatment for Parkinson's disease.,"INTRODUCTION


Accumulating evidence supports the evaluation of glucagon-like peptide-1 (GLP-1) receptor (R) agonists for the treatment of the underlying pathology causing Parkinson's Disease (PD). Not only are these effects evident in models of PD and other neurodegenerative disorders but recently in a randomized, double-blind, placebo-controlled clinical trial, a GLP-1R agonist has provided improved cognition motor functions in humans with moderate PD.
AREAS COVERED


In this mini-review, we describe the development of GLP-1R agonists and their potential therapeutic value in treating PD. Many GLP-1R agonists are FDA approved for the treatment of metabolic disorders, and hence can be rapidly repositioned for PD. Furthermore, we present preclinical data offering insights into the use of monomeric dual- and tri-agonist incretin-based mimetics for neurodegenerative disorders. These drugs combine active regions of GLP-1 with those of glucose-dependent insulinotropic peptide (GIP) and/or glucagon (Gcg).
EXPERT OPINION


GLP-1Ragonists offer a complementary and enhanced therapeutic value to other drugs used to treat PD. Moreover, the use of the dual- or tri-agonist GLP-1-based mimetics may provide combinatory effects that are even more powerful than GLP-1R agonism alone. We advocate for further investigations into the repurposing of GLP-1R agonists and the development of classes of multi-agonists for PD treatment.",2020,"Many GLP-1R agonists are FDA approved for the treatment of metabolic disorders, and hence can be rapidly repositioned for PD.","[""Parkinson's disease"", 'humans with moderate PD']","['Glucagon-like peptide-1 (GLP-1)-based receptor agonists', 'placebo']",['cognition motor functions'],"[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}]",,0.0631103,"Many GLP-1R agonists are FDA approved for the treatment of metabolic disorders, and hence can be rapidly repositioned for PD.","[{'ForeName': 'Elliot J', 'Initials': 'EJ', 'LastName': 'Glotfelty', 'Affiliation': 'Translational Gerontology Branch, Intramural Research Program, National Institute on Aging, National Institutes of Health , Baltimore, MD, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Olson', 'Affiliation': 'Department of Neuroscience, Karolinska Institutet , Stockholm, Sweden.'}, {'ForeName': 'Tobias E', 'Initials': 'TE', 'LastName': 'Karlsson', 'Affiliation': 'Department of Neuroscience, Karolinska Institutet , Stockholm, Sweden.'}, {'ForeName': 'Yazhou', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Translational Gerontology Branch, Intramural Research Program, National Institute on Aging, National Institutes of Health , Baltimore, MD, USA.'}, {'ForeName': 'Nigel H', 'Initials': 'NH', 'LastName': 'Greig', 'Affiliation': 'Translational Gerontology Branch, Intramural Research Program, National Institute on Aging, National Institutes of Health , Baltimore, MD, USA.'}]",Expert opinion on investigational drugs,['10.1080/13543784.2020.1764534']
787,31575336,Different preprocessing strategies lead to different conclusions: A [ 11 C]DASB-PET reproducibility study.,"Positron emission tomography (PET) neuroimaging provides unique possibilities to study biological processes in vivo under basal and interventional conditions. For quantification of PET data, researchers commonly apply different arrays of sequential data analytic methods (""preprocessing pipeline""), but it is often unknown how the choice of preprocessing affects the final outcome. Here, we use an available data set from a double-blind, randomized, placebo-controlled [ 11 C]DASB-PET study as a case to evaluate how the choice of preprocessing affects the outcome of the study. We tested the impact of 384 commonly used preprocessing strategies on a previously reported positive association between the change from baseline in neocortical serotonin transporter binding determined with [ 11 C]DASB-PET, and change in depressive symptoms, following a pharmacological sex hormone manipulation intervention in 30 women. The two preprocessing steps that were most critical for the outcome were motion correction and kinetic modeling of the dynamic PET data. We found that 36% of the applied preprocessing strategies replicated the originally reported finding ( p  < 0.05). For preprocessing strategies with motion correction, the replication percentage was 72%, whereas it was 0% for strategies without motion correction. In conclusion, the choice of preprocessing strategy can have a major impact on a study outcome.",2020,"For preprocessing strategies with motion correction, the replication percentage was 72%, whereas it was 0% for strategies without motion correction.",['30 women'],"['placebo', 'Positron emission tomography (PET', 'pharmacological sex hormone manipulation intervention']","['replication percentage', 'motion correction and kinetic modeling of the dynamic PET data']","[{'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0036884', 'cui_str': 'Gonadal Steroid Hormones'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}]","[{'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}]",384.0,0.255819,"For preprocessing strategies with motion correction, the replication percentage was 72%, whereas it was 0% for strategies without motion correction.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Nørgaard', 'Affiliation': 'Neurobiology Research Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Ganz', 'Affiliation': 'Neurobiology Research Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Svarer', 'Affiliation': 'Neurobiology Research Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Vibe G', 'Initials': 'VG', 'LastName': 'Frokjaer', 'Affiliation': 'Neurobiology Research Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Douglas N', 'Initials': 'DN', 'LastName': 'Greve', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Strother', 'Affiliation': 'Rotman Research Institute, Baycrest, Department of Medical Biophysics, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Gitte M', 'Initials': 'GM', 'LastName': 'Knudsen', 'Affiliation': 'Neurobiology Research Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}]",Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism,['10.1177/0271678X19880450']
788,28138837,Donepezil Plus Solifenacin (CPC-201) Treatment for Alzheimer's Disease.,"Available cholinergic drugs for treating Alzheimer's disease (AD) provide modest symptomatic benefit. We hypothesized that co-administration of a peripheral anticholinergic to reduce dose-limiting adverse effects (AEs) would enable the safe/tolerable use of higher cholinesterase inhibitor doses and thus improve their antidementia efficacy. A modified single-blind, ascending-dose, phase IIa study of donepezil plus solifenacin (CPC-201) lasting 26 weeks was conducted in 41 patients with probable AD of moderate severity. Entry criteria included the use of donepezil at a dose of 10 mg/day during the preceding 3 months. The primary outcome measure was the maximum tolerated dose (MTD) of donepezil achieved (to protocol limit of 40 mg/day) when administered with the anticholinergic solifenacin 15 mg/day. Secondary measures included assessments of cognitive and global function, as well as of AEs. The mean ± SD donepezil MTD increased to 38 ± 0.74 mg/day (median 40 mg/day; p < 0.001); 88% of the study population safely attained this dose at the end of titration. Markedly reduced donepezil AE frequency, especially gastrointestinal, allowed this dose increase. There were no drug-related serious AEs or clinically significant laboratory abnormalities. At 26 weeks, Alzheimer's Disease Assessment Scale Cognitive Component scores in the efficacy evaluable population improved by 0.35 ± 0.85 points over baseline (p < 0.05), an estimated 2.5 ± 0.84 points above 10 mg/day donepezil and 5.4 ± 0.84 points above historic placebo (both p < 0.05). Clinical Global Impression of Improvement scores improved by 0.94 ± 0.20 to 3.1 ± 0.20 points (p < 0.001). The findings suggest that limiting donepezil AEs by co-administration of solifenacin allows the safe administration of substantially higher cholinesterase inhibitors doses that may augment cognitive and global benefits in patients with AD.",2017,Clinical Global Impression of Improvement scores improved by 0.94 ± 0.20 to 3.1 ± 0.20 points (p < 0.001).,"['41 patients with probable AD of moderate severity', ""Alzheimer's Disease"", 'patients with AD']","['donepezil', 'Donepezil Plus Solifenacin (CPC-201', 'solifenacin', 'donepezil plus solifenacin', 'anticholinergic solifenacin']","[""Alzheimer's Disease Assessment Scale Cognitive Component scores"", 'mean\u2009±\u2009SD donepezil MTD', 'maximum tolerated dose (MTD) of donepezil', 'assessments of cognitive and global function, as well as of AEs', 'Clinical Global Impression of Improvement scores', 'donepezil AE frequency, especially gastrointestinal']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}]","[{'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1099677', 'cui_str': 'Solifenacin'}, {'cui': 'C0056911', 'cui_str': ""cytidylyl-(3'-5')-cytidine""}, {'cui': 'C0242896', 'cui_str': 'Anticholinergic Agents'}]","[{'cui': 'C0450989', 'cui_str': ""Alzheimer's disease assessment scale (assessment scale)""}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0752079', 'cui_str': 'Maximally Tolerated Dose'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",41.0,0.199273,Clinical Global Impression of Improvement scores improved by 0.94 ± 0.20 to 3.1 ± 0.20 points (p < 0.001).,"[{'ForeName': 'Thomas N', 'Initials': 'TN', 'LastName': 'Chase', 'Affiliation': 'Chase Pharmaceuticals, Inc, 1825 K Street NW, Washington, DC, 20006, USA. tchase@chasetherapeutics.com.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Farlow', 'Affiliation': 'Department of Neurology, Indiana University School of Medicine, 541 Clinical Drive, CL299, Indianapolis, IN, 46202, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Clarence-Smith', 'Affiliation': 'Chase Pharmaceuticals, Inc, 1825 K Street NW, Washington, DC, 20006, USA.'}]",Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics,['10.1007/s13311-016-0511-x']
789,30084949,A maximum likelihood approach to power calculations for stepped wedge designs of binary outcomes.,"In stepped wedge designs (SWD), clusters are randomized to the time period during which new patients will receive the intervention under study in a sequential rollout over time. By the study's end, patients at all clusters receive the intervention, eliminating ethical concerns related to withholding potentially efficacious treatments. This is a practical option in many large-scale public health implementation settings. Little statistical theory for these designs exists for binary outcomes. To address this, we utilized a maximum likelihood approach and developed numerical methods to determine the asymptotic power of the SWD for binary outcomes. We studied how the power of a SWD for detecting risk differences varies as a function of the number of clusters, cluster size, the baseline risk, the intervention effect, the intra-cluster correlation coefficient, and the time effect. We studied the robustness of power to the assumed form of the distribution of the cluster random effects, as well as how power is affected by variable cluster size. % SWD power is sensitive to neither, in contrast to the parallel cluster randomized design which is highly sensitive to variable cluster size. We also found that the approximate weighted least square approach of Hussey and Hughes (2007, Design and analysis of stepped wedge cluster randomized trials. Contemporary Clinical Trials 28, 182-191) for binary outcomes under-estimates the power in some regions of the parameter spaces, and over-estimates it in others. The new method was applied to the design of a large-scale intervention program on post-partum intra-uterine device insertion services for preventing unintended pregnancy in the first 1.5 years following childbirth in Tanzania, where it was found that the previously available method under-estimated the power.",2020,"Contemporary Clinical Trials 28, 182-191) for binary outcomes under-estimates the power in some regions of the parameter spaces, and over-estimates it in others.",[],[],[],[],[],[],,0.0305755,"Contemporary Clinical Trials 28, 182-191) for binary outcomes under-estimates the power in some regions of the parameter spaces, and over-estimates it in others.","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Epidemiology and Biostatistics, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA, USA.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Liao', 'Affiliation': 'Department of Epidemiology and Biostatistics, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA, USA and AbbVie Inc., 1400 Sheridan Rd, North Chicago, IL, USA.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Kunz', 'Affiliation': 'Deloitte, 30 Rockefeller Plaza, New York, NY, USA.'}, {'ForeName': 'Sharon-Lise T', 'Initials': 'ST', 'LastName': 'Normand', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA, USA.'}, {'ForeName': 'Molin', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology and Biostatistics, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Spiegelman', 'Affiliation': 'Department of Epidemiology and Biostatistics, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA, USA.'}]","Biostatistics (Oxford, England)",['10.1093/biostatistics/kxy031']
790,28993404,An internet-supported school physical activity intervention in low socioeconomic status communities: results from the Activity and Motivation in Physical Education (AMPED) cluster randomised controlled trial.,"OBJECTIVE


Quality physical education (PE) is the cornerstone of comprehensive school physical activity (PA) promotion programmes. We tested the efficacy of a teacher professional learning intervention, delivered partially via the internet, designed to maximise opportunities for students to be active during PE lessons and enhance adolescents' motivation towards PE and PA.
METHODS


A two-arm cluster randomised controlled trial with teachers and Grade 8 students from secondary schools in low socioeconomic areas of Western Sydney, Australia. The Activity and Motivation in Physical Education (AMPED) intervention for secondary school PE teachers included workshops, online learning, implementation tasks and mentoring sessions. The primary outcome was the proportion of PE lesson time that students spent in moderate-to-vigorous physical activity (MVPA), measured by accelerometers at baseline, postintervention (7-8 months after baseline) and maintenance (14-15 months). Secondary outcomes included observed PE teachers' behaviour during lessons, students' leisure-time PA and students' motivation.
RESULTS


Students (n=1421) from 14 schools completed baseline assessments and were included in linear mixed model analyses. The intervention had positive effects on students' MVPA during lessons. At postintervention, the adjusted mean difference in the proportion of lesson time spent in MVPA was 5.58% (p<0.001, approximately 4 min/lesson). During the maintenance phase, this effect was 2.64% (p<0.001, approximately 2 min/lesson). The intervention had positive effects on teachers' behaviour, but did not impact students' motivation.
CONCLUSIONS


AMPED produced modest improvements in MVPA and compares favourably with previous interventions delivered exclusively face-to-face. Online teacher training could help facilitate widespread dissemination of professional learning interventions.
TRIAL REGISTRATION NUMBER


ACTRN12614000184673.",2019,"During the maintenance phase, this effect was 2.64% (p<0.001, approximately 2 min/lesson).","['low socioeconomic status communities', 'Students (n=1421) from 14 schools completed baseline assessments and were included in linear mixed model analyses', 'A two-arm cluster randomised controlled trial with teachers and Grade 8 students from secondary schools in low socioeconomic areas of Western Sydney, Australia']","['Quality physical education (PE', 'teacher professional learning intervention', 'Physical Education (AMPED) intervention', 'internet-supported school physical activity intervention', 'Online teacher training']","['proportion of PE lesson time that students spent in moderate-to-vigorous physical activity (MVPA', ""PE teachers' behaviour during lessons, students' leisure-time PA and students' motivation"", 'proportion of lesson time spent in MVPA']","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0031805', 'cui_str': 'Physical Education'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4082803', 'cui_str': 'Teacher Training'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",1421.0,0.217079,"During the maintenance phase, this effect was 2.64% (p<0.001, approximately 2 min/lesson).","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Lonsdale', 'Affiliation': 'Institute for Positive Psychology and Education, Australian Catholic University, Strathfield, New South Wales, Australia.'}, {'ForeName': 'Aidan', 'Initials': 'A', 'LastName': 'Lester', 'Affiliation': 'Institute for Positive Psychology and Education, Australian Catholic University, Strathfield, New South Wales, Australia.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Owen', 'Affiliation': 'Institute for Positive Psychology and Education, Australian Catholic University, Strathfield, New South Wales, Australia.'}, {'ForeName': 'Rhiannon L', 'Initials': 'RL', 'LastName': 'White', 'Affiliation': 'Institute for Positive Psychology and Education, Australian Catholic University, Strathfield, New South Wales, Australia.'}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Peralta', 'Affiliation': 'School of Education and Social Work, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Morwenna', 'Initials': 'M', 'LastName': 'Kirwan', 'Affiliation': 'Faculty of Medicine and Health Sciences, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Thierno M O', 'Initials': 'TMO', 'LastName': 'Diallo', 'Affiliation': 'Institute for Positive Psychology and Education, Australian Catholic University, Strathfield, New South Wales, Australia.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Maeder', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bennie', 'Affiliation': 'School of Science and Health, Western Sydney University, Sydney, NSW, Australia.'}, {'ForeName': 'Freya', 'Initials': 'F', 'LastName': 'MacMillan', 'Affiliation': 'School of Science and Health, Western Sydney University, Sydney, NSW, Australia.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Kolt', 'Affiliation': 'Translational Health Research Institute, Western Sydney University, Sydney, NSW, Australia.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Ntoumanis', 'Affiliation': 'School of Psychology and Speech Pathology, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Gore', 'Affiliation': 'School of Education, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Cerin', 'Affiliation': 'Institute for Health and Ageing, Australian Catholic University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Dylan P', 'Initials': 'DP', 'LastName': 'Cliff', 'Affiliation': 'School of Education, University of Wollongong, Wollongong, New South Wales, Australia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lubans', 'Affiliation': 'School of Education, Priority Research Center in Physical Activity and Nutrition, University of Newcastle, Callaghan, New South Wales, Australia.'}]",British journal of sports medicine,['10.1136/bjsports-2017-097904']
791,31760817,Comparing Telephone Counseling With Reminding to Promote On-Time Repeated Mammography: A Randomized Trial in a Cohort With 4 Years Follow-Up.,"Background.  Long-term continuous adherence to biennial screening mammograms as guidelines recommend remains low. Limited evidence suggests that reminder calls may increase short-term adherence as much as telephone counseling, but research is needed comparing the long-term effects of these two approaches.  Purpose.  To compare the impacts of two telephone outreach interventions and mailed reminders on 4-year continuous mammography adherence.  Method.  A cohort of 3,215 women, age 50 to 81 years, was selected from 30,160 women from a 4-year randomized trial of three interventions to promote biennial mammography: reminder letter only (LO), letter plus reminder call (RC), and two letters plus educational material and a counseling call (CC). Women selected remained eligible for the trial all 4 years and received annual interventions as needed. The proportion with a mammogram in the last 24 months was determined at baseline and four annual time points.  Results.  Continuous adherence at all four time points was higher in the RC (78.8%) and CC arms (78.8%) than in the LO arm (75.1%;  p  < .001). Multivariable analysis confirmed this finding: CC (odds ratio = 1.27; 95% confidence interval = [1.01, 1.61]) and RC (odds ratio = 1.23; 95% confidence interval = [0.98, 1.56]). Only 27.8% of women eligible for an initial counseling call actually received counseling.  Conclusions.  Compared with letters alone, outreach calls can modestly increase continuous mammography adherence among insured women with consistent primary care. Telephone counseling was no more effective than a reminder call, possibly due to limited acceptance of counseling calls by women who may find them unwelcome or unnecessary.",2020,"Compared with letters alone, outreach calls can modestly increase continuous mammography adherence among insured women with consistent primary care.","['insured women with consistent primary care', '3,215 women, age 50 to 81 years, was selected from 30,160 women from a 4-year randomized trial of three', 'Women selected remained eligible for the trial all 4 years and received annual interventions as needed']","['Telephone counseling', 'interventions to promote biennial mammography: reminder letter only (LO), letter plus reminder call (RC), and two letters plus educational material and a counseling call (CC', 'Telephone Counseling With Reminding to Promote On-Time Repeated Mammography', 'telephone outreach interventions']","['Continuous adherence', 'continuous mammography adherence']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0557033', 'cui_str': 'Reminding (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}]",3215.0,0.116759,"Compared with letters alone, outreach calls can modestly increase continuous mammography adherence among insured women with consistent primary care.","[{'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Costanza', 'Affiliation': 'University of Massachusetts Medical School, Worcester, MA, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Luckmann', 'Affiliation': 'University of Massachusetts Medical School, Worcester, MA, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Frisard', 'Affiliation': 'University of Massachusetts Medical School, Worcester, MA, USA.'}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'White', 'Affiliation': 'University of Massachusetts Medical School, Worcester, MA, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Cranos', 'Affiliation': 'University of Massachusetts Medical School, Worcester, MA, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198119886347']
792,31539674,The impact of prolonged exposure therapy on social support and PTSD symptoms.,"BACKGROUND


Posttraumatic stress disorder (PTSD) results in high costs to society, particularly among military personnel. Much is known about PTSD treatments-such as exposure therapies-and their outcomes, but less is known about how treatment might impact social support and PTSD symptoms over the course of treatment.
METHODS


In the current study, soldiers with PTSD (N = 162) were randomized to complete prolonged exposure therapy (either with or without virtual reality) or a waitlist control condition. We examined the impact of treatment on perceived social support as a secondary treatment outcome, as well as the associations between social support and PTSD symptoms over time.
RESULTS


Exposure therapy increased perceived social support at the end of treatment compared to waitlist control, β = 0.43, 95% CI [0.13, 0.73]. Multigroup structural equation modeling using a cross-lagged panel design provided evidence that perceived social support was an antecedent of PTSD symptom improvement for participants engaging in treatment, but not for participants in the waitlist control. Treatment effects on change in PTSD symptoms was mediated by change in perceived social support (B = 1.10, 95% CI [0.20, 3.05]).
LIMITATIONS


The results should be considered in light of limitations, including the characteristics of the sample of active duty soldiers, the measurement of social support, and missingess over the course of the study.
CONCLUSIONS


These results suggest that increased perceived social support is a secondary outcome of exposure therapy and may be one pathway through which treatment reduces PTSD symptoms.",2020,"RESULTS


Exposure therapy increased perceived social support at the end of treatment compared to waitlist control, β = 0.43, 95% CI [0.13, 0.73].",['soldiers with PTSD (N\u202f=\u202f162'],"['prolonged exposure therapy', 'complete prolonged exposure therapy (either with or without virtual reality) or a waitlist control condition']","['perceived social support', 'social support and PTSD symptoms', 'PTSD symptoms']","[{'cui': 'C0524647', 'cui_str': 'Soldiers'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0037438'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0144893,"RESULTS


Exposure therapy increased perceived social support at the end of treatment compared to waitlist control, β = 0.43, 95% CI [0.13, 0.73].","[{'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Bourassa', 'Affiliation': 'VA Puget Sound Healthcare System, United States; University of Arizona, Department of Psychology, United States; Duke University Medical Center, Center for the Study of Aging and Human Development, United States.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Smolenski', 'Affiliation': 'Defense Health Agency, Psychological Health Center of Excellence, United States.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Edwards-Stewart', 'Affiliation': 'Defense Health Agency, Psychological Health Center of Excellence, United States.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Campbell', 'Affiliation': 'VA Puget Sound Healthcare System, United States; University of Washington School of Medicine, United States.'}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Reger', 'Affiliation': 'VA Puget Sound Healthcare System, United States; University of Washington School of Medicine, United States. Electronic address: greg.reger@va.gov.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Norr', 'Affiliation': 'VISN 20 Northwest Network Mental Illness Research, Education and Clinical Center (MIRECC), United States; University of Washington School of Medicine, United States.'}]",Journal of affective disorders,['10.1016/j.jad.2019.09.036']
793,28063976,"Effect of jaw-opening exercise on prevention of temporomandibular disorders pain associated with oral appliance therapy in obstructive sleep apnea patients: A randomized, double-blind, placebo-controlled trial.","PURPOSE


There are no studies on the prevention of temporomandibular joint and/or masticatory muscle pain (TMD pain) associated with oral appliance (OA) therapy in patients with obstructive sleep apnea (OSA). The aim of this study was to determine the effect of jaw-opening exercise on TMD pain associated with OA therapy in OSA patients.
METHODS


Twenty-five OSA patients without pain-related TMD were consecutively enrolled into a two-arm, randomized, double-blind, placebo-controlled trial. One group performed jaw-opening exercise (JE, n=13), and the other group performed placebo exercise (PE, n=12) for 1-month, and had started 2-weeks prior to insertion of an adjustable OA. TMD sign using the Research Diagnostic Criteria for Temporomandibular Disorders and TMD pain intensity using a visual analog scale (VAS) in the morning and daytime were evaluated at baseline (pre-exercise) and at 2-weeks, 1-month, and 3-months after OA insertion.
RESULTS


Pain-related TMD was not observed in the JE-group at all evaluation periods, although one subject in the PE-group was diagnosed with arthralgia at the 1-month evaluation. The JE-group showed lower morning and daytime VAS scores than the those of the PE-group at all evaluation periods, and significant group differences were found in terms of chewing pain and jaw-opening pain in the morning at the 1-month evaluation, and of jaw-opening pain during daytime at the 3-month evaluation (P<0.05).
CONCLUSIONS


Within the limitations of the study, jaw-opening exercise prior to OA therapy reduced the risk of TMD pain associated with OA use. Therefore, jaw-opening exercise may contribute to the prevention of TMD pain.",2017,"The JE-group showed lower morning and daytime VAS scores than the those of the PE-group at all evaluation periods, and significant group differences were found in terms of chewing pain and jaw-opening pain in the morning at the 1-month evaluation, and of jaw-opening pain during daytime at the 3-month evaluation (P<0.05).
","['Twenty-five OSA patients without pain-related TMD', 'obstructive sleep apnea patients', 'patients with obstructive sleep apnea (OSA', 'OSA patients']","['jaw-opening exercise (JE, n=13), and the other group performed placebo exercise (PE, n=12) for 1-month, and had started 2-weeks prior to insertion of an adjustable OA', 'placebo', 'OA therapy', 'oral appliance therapy', 'jaw-opening exercise', 'oral appliance (OA) therapy']","['morning and daytime VAS scores', 'temporomandibular disorders pain', 'chewing pain and jaw-opening pain', 'risk of TMD pain', 'Pain-related TMD', 'temporomandibular joint and/or masticatory muscle pain (TMD pain', 'TMD pain']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0243112'}]","[{'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0039494', 'cui_str': 'TMJ Diseases'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0699816', 'cui_str': 'Does chew (finding)'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0039493', 'cui_str': 'TMJ'}, {'cui': 'C0024890', 'cui_str': 'Masticatory muscles'}]",25.0,0.193557,"The JE-group showed lower morning and daytime VAS scores than the those of the PE-group at all evaluation periods, and significant group differences were found in terms of chewing pain and jaw-opening pain in the morning at the 1-month evaluation, and of jaw-opening pain during daytime at the 3-month evaluation (P<0.05).
","[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Ishiyama', 'Affiliation': 'Orofacial Pain Management, Department of Oral Health Sciences Graduate School, Tokyo Medical and Dental University, Tokyo, Japan; Dental Clinic for Sleep Disorders (Apnea and Snoring), Oral and Maxillofacial Rehabilitation, Dental Hospital, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Shusuke', 'Initials': 'S', 'LastName': 'Inukai', 'Affiliation': 'Dental Clinic for Sleep Disorders (Apnea and Snoring), Oral and Maxillofacial Rehabilitation, Dental Hospital, Tokyo Medical and Dental University, Tokyo, Japan; Removable Partial Prosthodontics, Oral Health Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan. Electronic address: shu.inukai.rpro@tmd.ac.jp.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Nishiyama', 'Affiliation': 'Orofacial Pain Management, Department of Oral Health Sciences Graduate School, Tokyo Medical and Dental University, Tokyo, Japan; Dental Clinic for Sleep Disorders (Apnea and Snoring), Oral and Maxillofacial Rehabilitation, Dental Hospital, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Hideshima', 'Affiliation': 'Dental Clinic for Sleep Disorders (Apnea and Snoring), Oral and Maxillofacial Rehabilitation, Dental Hospital, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Dental Clinic for Sleep Disorders (Apnea and Snoring), Oral and Maxillofacial Rehabilitation, Dental Hospital, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Meiyo', 'Initials': 'M', 'LastName': 'Tamaoka', 'Affiliation': 'Department of Sleep Modulatory Medicine, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Yasunari', 'Initials': 'Y', 'LastName': 'Miyazaki', 'Affiliation': 'Health Administration Center, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Fueki', 'Affiliation': 'Removable Partial Prosthodontics, Oral Health Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Wakabayashi', 'Affiliation': 'Removable Partial Prosthodontics, Oral Health Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}]",Journal of prosthodontic research,['10.1016/j.jpor.2016.12.001']
794,32412986,"Subarachnoid block and ultrasound-guided transversalis fascia plane block for caesarean section: A randomised, double-blind, placebo-controlled trial.","BACKGROUND


After caesarean section, maternal postoperative comfort is critical to allow the new mother to care for her baby. Insufficient pain relief during the postoperative period may delay maternal/infant bonding and, in addition, such pain has been linked to subsequent depression and chronic pain. Caesarean section is commonly performed with a Pfannenstiel incision, and a transversalis fascia plane (TFP) block provides postoperative analgesia in the T12 and L1 dermatomes.
OBJECTIVE


The aim of this study was to investigate the effect of the TFP block on postoperative opioid consumption and pain scores in patients undergoing caesarean section under spinal anaesthesia.
DESIGN


A randomised controlled, double-blind study.
SETTINGS


Single-centre, academic hospital.
PARTICIPANTS


Sixty patients undergoing caesarean section.
INTERVENTIONS


The TFP group (n = 30) received an ultrasound-guided bilateral TFP block with 20 ml of 0.25% bupivacaine. The control group (n = 30) received 20 ml of saline bilaterally. Postoperative analgesia was given every 6 h with intravenous paracetamol 1 g and patient-controlled analgesia (PCA) with morphine.
MAIN OUTCOME MEASURES


Postoperative visual analogue pain scores, morphine consumption, rescue analgesia and opioid-related side effects were evaluated.
RESULTS


In the TFP group, the visual analogue pain scores were significantly lower at rest for 2 h after the operation (P = 0.011) and during active movement at 2, 4 and 8 h postoperatively (P = 0.014, <0.001 and 0.032, respectively). Morphine consumption in the first 24 h after surgery was significantly higher in the control group compared with the TFP group (38.5 ± 11.63 and 19.5 ± 8.33 mg, respectively; P < 0.001). The incidence of postoperative nausea and constipation were statistically higher in the control group than in the TFP group (P < 0.05). Patient satisfaction was significantly higher in the TFP group (P = 0.027).
CONCLUSION


A postoperative TFP block can reduce opioid consumption and relieve acute pain after a caesarean section under spinal anaesthesia.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04172727.",2020,The incidence of postoperative nausea and constipation were statistically higher in the control group than in the TFP group (P < 0.05).,"['Single-centre, academic hospital', 'patients undergoing caesarean section under spinal anaesthesia', 'caesarean section', 'Sixty patients undergoing caesarean section']","['transversalis fascia plane (TFP) block', 'ultrasound-guided bilateral TFP block with 20\u200aml of 0.25% bupivacaine', 'paracetamol 1 g and patient-controlled analgesia (PCA) with morphine', 'TFP', 'Subarachnoid block and ultrasound-guided transversalis fascia plane block', '20\u200aml of saline bilaterally', 'TFP block', 'placebo']","['Patient satisfaction', 'postoperative opioid consumption and pain scores', 'postoperative nausea and constipation', 'visual analogue pain scores', 'Morphine consumption', 'Postoperative visual analogue pain scores, morphine consumption, rescue analgesia and opioid-related side effects', 'acute pain']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0225232', 'cui_str': 'Transversalis fascia structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}]",60.0,0.485841,The incidence of postoperative nausea and constipation were statistically higher in the control group than in the TFP group (P < 0.05).,"[{'ForeName': 'Muhammed E', 'Initials': 'ME', 'LastName': 'Aydin', 'Affiliation': 'From the Department of Anaesthesiology and Reanimation, Ataturk University Faculty of Medicine (MEA, AMY, ECC, IA, EOA, AA), Clinical Research, Development and Design Application and Research Center, Ataturk University School of Medicine (MEA, AMY, ECC, AA), and Nenehatun State Hospital, Erzurum, Turkey (ZB).'}, {'ForeName': 'Zehra', 'Initials': 'Z', 'LastName': 'Bedir', 'Affiliation': ''}, {'ForeName': 'Ahmet M', 'Initials': 'AM', 'LastName': 'Yayik', 'Affiliation': ''}, {'ForeName': 'Erkan C', 'Initials': 'EC', 'LastName': 'Celik', 'Affiliation': ''}, {'ForeName': 'İrem', 'Initials': 'İ', 'LastName': 'Ates', 'Affiliation': ''}, {'ForeName': 'Elif O', 'Initials': 'EO', 'LastName': 'Ahiskalioglu', 'Affiliation': ''}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ahiskalioglu', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001222']
795,31594193,"Gait training with auditory feedback improves trunk control, muscle activation and dynamic balance in patients with hemiparetic stroke: A randomized controlled pilot study.","BACKGROUND


Auditory feedback enables an individual to identify and modify the differences between actual and intended movement during the motor learning process.
OBJECTIVE


We investigated the effects of gait training with auditory feedback on trunk control, muscle activation, and dynamic balance in patients with hemiparetic stroke.
METHODS


Twenty participants with hemiparetic stroke were recruited in this study and randomly assigned to the experimental (n= 10) or control (n= 10) group. The subjects in the experimental group participated in gait training with auditory feedback for 30 minutes, 5 times a week, for 4 weeks, whereas those in the control group received conventional gait training for 30 minutes, 5 times a week, for 4 weeks. During auditory feedback training, a beeping sound is produced every time a patient loaded weight that was higher than the preset threshold on the cane. Activation of the erector spinae muscle was measured using surface electromyography, and trunk control was evaluated using the Trunk Impairment Scale (TIS). Dynamic balance was measured using the Timed Up and Go (TUG) test.
RESULTS


Muscle activation was significantly higher in the experimental group than in the control group (6.6 ± 9.2% vs 1.4 ± 5.4% nonparetic peak activity). No significant difference was found in the TIS score between the experimental and control groups. Based on the TUG test, a significant improvement was observed in the experimental group compared to the control group (12.1 ± 11.4 vs 3.8 ± 4.7 s).
CONCLUSION


Our findings indicate that gait training with auditory feedback was beneficial for improving trunk control and muscle activation in patients with hemiparetic stroke.",2020,"RESULTS


Muscle activation was significantly higher in the experimental group than in the control group (6.6 ± 9.2% vs 1.4 ± 5.4% nonparetic peak activity).","['patients with hemiparetic stroke', 'Twenty participants with hemiparetic stroke']","['Gait training with auditory feedback', 'gait training with auditory feedback', 'conventional gait training']","['Muscle activation', 'Dynamic balance', 'TIS score', 'Trunk Impairment Scale (TIS', 'trunk control, muscle activation and dynamic balance', 'trunk control, muscle activation, and dynamic balance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C0085673', 'cui_str': 'Gait training procedure (procedure)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0426971', 'cui_str': 'Trunk control (observable entity)'}]",20.0,0.0153752,"RESULTS


Muscle activation was significantly higher in the experimental group than in the control group (6.6 ± 9.2% vs 1.4 ± 5.4% nonparetic peak activity).","[{'ForeName': 'Kyoung-Sim', 'Initials': 'KS', 'LastName': 'Jung', 'Affiliation': 'Department of Occupational Therapy, Semyung University, Jecheon, Korea.'}, {'ForeName': 'Hyunsoo', 'Initials': 'H', 'LastName': 'Bang', 'Affiliation': 'Department of Physical Therapy, Gimcheon University, Gimcheon, Korea.'}, {'ForeName': 'Tae-Sung', 'Initials': 'TS', 'LastName': 'In', 'Affiliation': 'Department of Physical Therapy, Gimcheon University, Gimcheon, Korea.'}, {'ForeName': 'Hwi-Young', 'Initials': 'HY', 'LastName': 'Cho', 'Affiliation': 'Department of Physical Therapy, Gachon University, Incheon, Korea.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-170852']
796,31747840,Nintedanib: New indication for systemic sclerosis-associated interstitial lung disease.,"Nintedanib (Ofev™), an oral triple kinase inhibitor targeting pro-fibrotic pathways, has been used for treatment of idiopathic pulmonary fibrosis (IPF). Based on positive results from phase III, placebo-controlled, randomized comparative clinical trial conducted in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), nintedanib received marketing approval in the United States and Japan for the treatment of SSc-ILD. Nintedanib significantly reduced the annual rate of decline in forced vital capacity over 52 weeks compared with placebo. The safety profiles observed in this trial were consistent with those reported in IPF patients, and the most common adverse events were gastrointestinal disorders, including diarrhea, nausea, and vomiting, which sometimes lead to discontinuation or permanent dose reduction of nintedanib. In contrast, serious adverse events were infrequent and were related mostly to worsening of cardiopulmonary involvement of SSc. This review summarizes the milestones in development of nintedanib leading to the approval for the treatment of SSc-ILD, and covers mechanisms of action, efficacy results and safety profiles, and future perspectives of nintedanib.",2020,Nintedanib significantly reduced the annual rate of decline in forced vital capacity over 52 weeks compared with placebo.,"['patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD', 'idiopathic pulmonary fibrosis (IPF']",['placebo'],"['diarrhea, nausea, and vomiting', 'serious adverse events', 'annual rate of decline in forced vital capacity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036421', 'cui_str': 'Systemic Scleroderma'}, {'cui': 'C1869044', 'cui_str': 'Interstitial lung disease (SMQ)'}, {'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}]",,0.0438449,Nintedanib significantly reduced the annual rate of decline in forced vital capacity over 52 weeks compared with placebo.,"[{'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Kuwana', 'Affiliation': 'Department of Allergy and Rheumatology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Arata', 'Initials': 'A', 'LastName': 'Azuma', 'Affiliation': 'Department of Pulmonary, Infection and Oncology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.'}]",Modern rheumatology,['10.1080/14397595.2019.1696505']
797,32413812,Effects of a mindfulness based behavioral intervention for young adults with childhood maltreatment history on hippocampal morphometry: a pilot MRI study with voxel-based morphometry.,"Childhood maltreatment has long lasting impacts on neural development of the hippocampus, which is important for learning and memory. The present study aimed to assess the effects of a mindfulness based intervention on hippocampal morphometry and episodic memory in this population. We administered MRI, psychological questionnaires and an episodic memory task to 21 participants (5 males) before and after a mindfulness-based behavioral intervention, compared to 21 participants (7 males) on the waiting list. Changes in Gray Matter Volume (GMV) in bilateral hippocampi were analyzed with Voxel-Based Morphometry (VBM). One cluster was identified in the right hippocampus with a group by time interaction effect that consisted of 130 contiguous voxels but fell short of significance with full FDR correction (p = 0.077). GMV in this cluster increased by 0.76% in the mindfulness group and decreased by 0.78% in the control group. Within the mindfulness group, changes in hippocampal GMV were negatively associated with changes in perceived stress and depression severity and positively associated with enhancement in performance accuracy on the episodic memory task. Findings from this pilot study suggest that a mindfulness-based intervention may lead to an increase in partial hippocampal GMV with associated symptom reduction and improvement in episodic memory.",2020,GMV in this cluster increased by 0.76% in the mindfulness group and decreased by 0.78% in the control group.,"['21 participants (5 males) before and after a', 'young adults with childhood maltreatment history on hippocampal morphometry']","['mindfulness based intervention', 'mindfulness-based behavioral intervention', 'mindfulness based behavioral intervention']","['perceived stress and depression severity', 'GMV', 'hippocampal morphometry and episodic memory', 'episodic memory', 'hippocampal GMV', 'partial hippocampal GMV', 'Gray Matter Volume (GMV']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0200760', 'cui_str': 'Morphometric analysis'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0200760', 'cui_str': 'Morphometric analysis'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0728938', 'cui_str': 'Partial'}]",130.0,0.0170544,GMV in this cluster increased by 0.76% in the mindfulness group and decreased by 0.78% in the control group.,"[{'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Joss', 'Affiliation': 'Developmental Biopsychiatry Research Program, McLean Hospital, Belmont, MA, USA; Department of Psychiatry, Massachusetts General Hospital, USA; Department of Psychiatry, Harvard Medical School, Boston, USA. Electronic address: djoss@mclean.harvard.edu.'}, {'ForeName': 'Sara W', 'Initials': 'SW', 'LastName': 'Lazar', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, USA; Department of Psychiatry, Harvard Medical School, Boston, USA.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Teicher', 'Affiliation': 'Developmental Biopsychiatry Research Program, McLean Hospital, Belmont, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, USA.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2020.111087']
798,31599351,Cognitive behavioral therapy in adolescents with early-onset psychosis: a randomized controlled pilot study.,"Cognitive behavioral therapy for psychosis (CBT) is an effective treatment in adult patients with schizophrenia. However, no randomized controlled and blinded trial in adolescents with early-onset psychosis (EOP) has been conducted. Therefore, the present pilot study explores the acceptance, tolerability, feasibility, and safety of a modified CBT in adolescents with EOP. Twenty-five adolescents with EOP were randomized to either 9 months (20 sessions) of CBT + treatment as usual (TAU) or TAU alone. The primary endpoint was the PANSS-positive subscale (P1-7). Secondary endpoints included psychopathology, global functioning, and quality of life (QoL). Acceptance, tolerability, feasibility, and safety were assessed. Blinded assessments took place by the end of the treatment (9 months) and at 24-month follow-up. Despite improvements in both groups and lack of statistical significance between CBT + TAU and TAU regarding the primary endpoint, we observed between-group effect sizes of at least d = 0.39 in favor of CBT + TAU at post-treatment for delusions, negative symptoms, functioning and QoL after the intervention and effect sizes of at least d = 0.35 after 24 months. CBT in EOP was highly acceptable (73.5% agreed to randomization), well-tolerated (83.1% attendance rate, no drop-outs), and safe (one serious adverse event (SAE) in CBT + TAU in comparison with six SAEs in TAU). These findings suggest that CBT adapted to the needs of adolescents with EOP is a promising approach regarding negative symptoms, functioning, and QoL. CBT is a safe and tolerable treatment. However, due to the small sample size and the pilot character of the study, these conclusions are limited, and should be tested in a larger, adequately powered randomized controlled trial.",2020,"Despite improvements in both groups and lack of statistical significance between CBT + TAU and TAU regarding the primary endpoint, we observed between-group effect sizes of at least d = 0.39 in favor of CBT + TAU at post-treatment for delusions, negative symptoms, functioning and QoL after the intervention and effect sizes of at least d = 0.35 after 24 months.","['Twenty-five adolescents with EOP', 'adolescents with early-onset psychosis', 'adult patients with schizophrenia', 'adolescents with early-onset psychosis (EOP', 'adolescents with EOP']","['Cognitive behavioral therapy', 'modified CBT', 'CBT', 'CBT\u2009+\u2009treatment as usual (TAU) or TAU alone']","['tolerated', 'psychopathology, global functioning, and quality of life (QoL', 'Acceptance, tolerability, feasibility, and safety', 'PANSS-positive subscale (P1-7', 'acceptance, tolerability, feasibility, and safety']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",25.0,0.118217,"Despite improvements in both groups and lack of statistical significance between CBT + TAU and TAU regarding the primary endpoint, we observed between-group effect sizes of at least d = 0.39 in favor of CBT + TAU at post-treatment for delusions, negative symptoms, functioning and QoL after the intervention and effect sizes of at least d = 0.35 after 24 months.","[{'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Müller', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Mareike', 'Initials': 'M', 'LastName': 'Kommescher', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Jörn', 'Initials': 'J', 'LastName': 'Güttgemanns', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Wessels', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Walger', 'Affiliation': 'Department of Childhood and Adolescent Psychiatry and Psychotherapy, Department of Psychiatry and Psychotherapy, Faculty of Medicine, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Lehmkuhl', 'Affiliation': 'Department of Childhood and Adolescent Psychiatry and Psychotherapy, Department of Psychiatry and Psychotherapy, Faculty of Medicine, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Kuhr', 'Affiliation': 'Faculty of Medicine, Institute of Medical Statistics and Computational Biology, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hamacher', 'Affiliation': 'Faculty of Medicine, Institute of Medical Statistics and Computational Biology, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Lehmacher', 'Affiliation': 'Faculty of Medicine, Institute of Medical Statistics and Computational Biology, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Müller', 'Affiliation': 'Kinder- und Jugendwohnheim Leppermühle, Leppermühle 1, 35418, Buseck, Germany.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Herrlich', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatic Medicine, Goethe University Hospital Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt am Main, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Wiedemann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Klinikum Fulda, Pacelliallee 4, 36043, Fulda, Germany.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Stösser', 'Affiliation': 'Department of Childhood and Adolescent Psychiatry and Psychotherapy, University of Tübingen, Geissweg 3, 72076, Tübingen, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Klingberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Geissweg 3, 72076, Tübingen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Bechdolf', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, University Hospital Cologne, Cologne, Germany. andreas.bechdolf@vivantes.de.'}]",European child & adolescent psychiatry,['10.1007/s00787-019-01415-4']
799,31513968,Verbal memory predicts treatment outcome in syndromal anxious depression: An iSPOT-D report.,"BACKGROUND


Major Depressive Disorder (MDD), anxiety disorders, and high levels of anxious symptoms are associated with impaired cognitive functioning. However, little is known of how cognitive functioning is impaired in people with anxious depression. Here, we compared cognitive functioning between people with anxious depression, non-anxious depression, and healthy controls. We also tested whether anxious depression moderated the relationship between cognitive functioning and treatment outcome.
METHODS


1008 adults with MDD and 336 healthy controls completed IntegNeuro: a computerized cognitive functioning test battery. Participants were then randomised to one of three antidepressants and reassessed at 8 weeks using the 17-item Hamilton Depression Rating Scale (HRSD 17 ) and the 16-Item Quick Inventory of Depressive Symptomatology-Self-Rated for remission and response. Syndromal anxious depression was defined as MDD with a comorbid anxiety disorder. HRSD anxious depression was defined as MDD with a comorbid HRSD 17  anxiety/somatisation factor score ≥ 7.
RESULTS


Syndromal anxious depression was associated with better psychomotor functioning and poorer working memory, cognitive flexibility and information processing speed compared to their non-anxious counterparts. HRSD anxious depression was associated with better psychomotor functioning compared to their non-anxious counterparts. Syndromal anxious depression moderated the relationship between verbal memory and treatment outcome. In people with syndromal anxious depression, poorer baseline verbal memory predicted poorer treatment outcome.
LIMITATIONS


As DSM-IV criteria was used, the DSM-5 anxious distress specifier characterisation of anxious depression could not be assessed CONCLUSIONS: Syndromal anxious depression is characterised by impaired executive functions and moderates the relationship between verbal memory functioning and treatment outcome.",2020,"RESULTS


Syndromal anxious depression was associated with better psychomotor functioning and poorer working memory, cognitive flexibility and information processing speed compared to their non-anxious counterparts.","['1008 adults with MDD and 336 healthy controls completed IntegNeuro', 'people with anxious depression, non-anxious depression, and healthy controls', 'people with anxious depression']","['computerized cognitive functioning test battery', 'Verbal memory']","['syndromal anxious depression', 'psychomotor functioning and poorer working memory, cognitive flexibility and information processing speed', '17-item Hamilton Depression Rating Scale (HRSD 17 ) and the 16-Item Quick Inventory of Depressive Symptomatology-Self-Rated for remission and response', 'HRSD anxious depression', 'Syndromal anxious depression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder (disorder)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}]","[{'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder (disorder)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology (assessment scale)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",1008.0,0.0694738,"RESULTS


Syndromal anxious depression was associated with better psychomotor functioning and poorer working memory, cognitive flexibility and information processing speed compared to their non-anxious counterparts.","[{'ForeName': 'Taylor A', 'Initials': 'TA', 'LastName': 'Braund', 'Affiliation': 'Brain Dynamics Centre, The Westmead Institute for Medical Research, Sydney, NSW, Australia; Discipline of Psychiatry, Sydney Medical School, University of Sydney, Sydney, NSW, Australia; The Brain Resource Company, Sydney, NSW, Australia. Electronic address: taylor.braund@sydney.edu.au.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Tillman', 'Affiliation': 'Australian College of Applied Psychology, Sydney, NSW, Australia.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Palmer', 'Affiliation': 'Brain Dynamics Centre, The Westmead Institute for Medical Research, Sydney, NSW, Australia; The Brain Resource Company, Sydney, NSW, Australia.'}, {'ForeName': 'Anthony W F', 'Initials': 'AWF', 'LastName': 'Harris', 'Affiliation': 'Brain Dynamics Centre, The Westmead Institute for Medical Research, Sydney, NSW, Australia; Discipline of Psychiatry, Sydney Medical School, University of Sydney, Sydney, NSW, Australia.'}]",Journal of affective disorders,['10.1016/j.jad.2019.09.028']
800,28280092,A Phase I/Ib Study of Enzalutamide Alone and in Combination with Endocrine Therapies in Women with Advanced Breast Cancer.,"Purpose:  Several lines of evidence support targeting the androgen signaling pathway in breast cancer. Enzalutamide is a potent inhibitor of androgen receptor signaling. Preclinical data in estrogen-expressing breast cancer models demonstrated activity of enzalutamide monotherapy and enhanced activity when combined with various endocrine therapies (ET). Enzalutamide is a strong cytochrome P450 3A4 (CYP3A4) inducer, and ETs are commonly metabolized by CYP3A4. The pharmacokinetic (PK) interactions, safety, and tolerability of enzalutamide monotherapy and in combination with ETs were assessed in this phase I/Ib study. Experimental Design:  Enzalutamide monotherapy was assessed in dose-escalation and dose-expansion cohorts of patients with advanced breast cancer. Additional cohorts examined effects of enzalutamide on anastrozole, exemestane, and fulvestrant PK in patients with estrogen receptor-positive/progesterone receptor-positive (ER + /PgR + ) breast cancer. Results:  Enzalutamide monotherapy ( n  = 29) or in combination with ETs ( n  = 70) was generally well tolerated. Enzalutamide PK in women was similar to prior data on PK in men with prostate cancer. Enzalutamide decreased plasma exposure to anastrozole by approximately 90% and exemestane by approximately 50%. Enzalutamide did not significantly affect fulvestrant PK. Exposure of exemestane 50 mg/day given with enzalutamide was similar to exemestane 25 mg/day alone. Conclusions:  These results support a 160 mg/day enzalutamide dose in women with breast cancer. Enzalutamide can be given in combination with fulvestrant without dose modifications. Exemestane should be doubled from 25 mg/day to 50 mg/day when given in combination with enzalutamide; this combination is being investigated in a randomized phase II study in patients with ER + /PgR +  breast cancer.  Clin Cancer Res; 23(15); 4046-54. ©2017 AACR .",2017,Enzalutamide decreased plasma exposure to anastrozole by approximately 90% and exemestane by approximately 50%.,"['patients with advanced breast cancer', 'patients with ER + /PgR +  breast cancer', 'Women with Advanced Breast Cancer', 'men with prostate cancer', 'women with breast cancer', 'breast cancer', 'patients with estrogen receptor-positive/progesterone receptor-positive (ER + /PgR + ) breast cancer']","['Exemestane', 'Enzalutamide monotherapy', 'enzalutamide', 'anastrozole, exemestane, and fulvestrant PK', 'Enzalutamide PK', 'exemestane', 'Enzalutamide Alone and in Combination with Endocrine Therapies', 'fulvestrant', 'Enzalutamide']","['pharmacokinetic (PK) interactions, safety, and tolerability', 'plasma exposure to anastrozole', 'fulvestrant PK', 'tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0034804', 'cui_str': 'Estrogen Receptors'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0034833', 'cui_str': 'Receptors, Progestin'}]","[{'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}]","[{'cui': 'C1868980', 'cui_str': 'Pharmacokinetic interaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}]",,0.0302311,Enzalutamide decreased plasma exposure to anastrozole by approximately 90% and exemestane by approximately 50%.,"[{'ForeName': 'Lee S', 'Initials': 'LS', 'LastName': 'Schwartzberg', 'Affiliation': 'West Cancer Center, Memphis, Tennessee.'}, {'ForeName': 'Denise A', 'Initials': 'DA', 'LastName': 'Yardley', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, Tennessee.'}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Elias', 'Affiliation': 'Division of Medical Oncology, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, Tennessee.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'LoRusso', 'Affiliation': 'Department of Internal Medicine, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Howard A', 'Initials': 'HA', 'LastName': 'Burris', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, Tennessee.'}, {'ForeName': 'Ayca', 'Initials': 'A', 'LastName': 'Gucalp', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Peterson', 'Affiliation': 'Medivation, Inc. (Medivation, Inc., was acquired by Pfizer, Inc., in September 2016), San Francisco, California.'}, {'ForeName': 'Martha E', 'Initials': 'ME', 'LastName': 'Blaney', 'Affiliation': 'Medivation, Inc. (Medivation, Inc., was acquired by Pfizer, Inc., in September 2016), San Francisco, California.'}, {'ForeName': 'Joyce L', 'Initials': 'JL', 'LastName': 'Steinberg', 'Affiliation': 'Astellas Pharma, Inc., Northbrook, Illinois.'}, {'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'Gibbons', 'Affiliation': 'Medivation, Inc. (Medivation, Inc., was acquired by Pfizer, Inc., in September 2016), San Francisco, California.'}, {'ForeName': 'Tiffany A', 'Initials': 'TA', 'LastName': 'Traina', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York. trainat@mskcc.org.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-16-2339']
801,28004273,Occipital Nerve Field Transcranial Direct Current Stimulation Normalizes Imbalance Between Pain Detecting and Pain Inhibitory Pathways in Fibromyalgia.,"Occipital nerve field (OCF) stimulation with subcutaneously implanted electrodes is used to treat headaches, more generalized pain, and even failed back surgery syndrome via unknown mechanisms. Transcranial direct current stimulation (tDCS) can predict the efficacy of implanted electrodes. The purpose of this study is to unravel the neural mechanisms involved in global pain suppression, mediated by occipital nerve field stimulation, within the realm of fibromyalgia. Nineteen patients with fibromyalgia underwent a placebo-controlled OCF tDCS. Electroencephalograms were recorded at baseline after active and sham stimulation. In comparison with healthy controls, patients with fibromyalgia demonstrate increased dorsal anterior cingulate cortex, increased premotor/dorsolateral prefrontal cortex activity, and an imbalance between pain-detecting dorsal anterior cingulate cortex and pain-suppressing pregenual anterior cingulate cortex activity, which is normalized after active tDCS but not sham stimulation associated with increased pregenual anterior cingulate cortex activation. The imbalance improvement between the pregenual anterior cingulate cortex and the dorsal anterior cingulate cortex is related to clinical changes. An imbalance assumes these areas communicate and, indeed, abnormal functional connectivity between the dorsal anterior cingulate cortex and pregenual anterior cingulate cortex is noted to be caused by a dysfunctional effective connectivity from the pregenual anterior cingulate cortex to the dorsal anterior cingulate cortex, which improves and normalizes after real tDCS but not sham tDCS. In conclusion, OCF tDCS exerts its effect via activation of the descending pain inhibitory pathway and de-activation of the salience network, both of which are abnormal in fibromyalgia.",2017,"In comparison with healthy controls, patients with fibromyalgia demonstrate increased dorsal anterior cingulate cortex, increased premotor/dorsolateral prefrontal cortex activity, and an imbalance between pain-detecting dorsal anterior cingulate cortex and pain-suppressing pregenual anterior cingulate cortex activity, which is normalized after active tDCS but not sham stimulation associated with increased pregenual anterior cingulate cortex activation.","['Fibromyalgia', 'Nineteen patients with fibromyalgia underwent a']","['placebo-controlled OCF tDCS', 'Occipital Nerve Field Transcranial Direct Current Stimulation Normalizes Imbalance', 'Occipital nerve field (OCF) stimulation with subcutaneously implanted electrodes', 'OCF tDCS', 'Transcranial direct current stimulation (tDCS']","['pregenual anterior cingulate cortex activation', 'dorsal anterior cingulate cortex, increased premotor/dorsolateral prefrontal cortex activity, and an imbalance between pain-detecting dorsal anterior cingulate cortex and pain-suppressing pregenual anterior cingulate cortex activity']","[{'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1283707', 'cui_str': 'Occipital nerve'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0013814', 'cui_str': 'Implantable Electrodes'}]","[{'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}]",19.0,0.019517,"In comparison with healthy controls, patients with fibromyalgia demonstrate increased dorsal anterior cingulate cortex, increased premotor/dorsolateral prefrontal cortex activity, and an imbalance between pain-detecting dorsal anterior cingulate cortex and pain-suppressing pregenual anterior cingulate cortex activity, which is normalized after active tDCS but not sham stimulation associated with increased pregenual anterior cingulate cortex activation.","[{'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'De Ridder', 'Affiliation': 'Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Vanneste', 'Affiliation': 'Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand. sven.vanneste@utdallas.edu.'}]",Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics,['10.1007/s13311-016-0493-8']
802,32413933,Adalimumab for maintenance of remission in Crohn's disease.,"BACKGROUND


Conventional medications for Crohn's disease (CD) include anti-inflammatory drugs, immunosuppressants and corticosteroids. If an individual does not respond, or loses response to first-line treatments, then biologic therapies such as tumour necrosis factor-alpha (TNF-α) antagonists such as adalimumab are considered for treating CD. Maintenance of remission of CD is a clinically important goal, as disease relapse can negatively affect quality of life.
OBJECTIVES


To assess the efficacy and safety of adalimumab for maintenance of remission in people with quiescent CD.
SEARCH METHODS


We searched the Cochrane IBD Group Specialized Register, CENTRAL, MEDLINE, Embase, and clinicaltrials.gov from inception to April 2019.
SELECTION CRITERIA


We considered for inclusion randomized controlled trials (RCTs) comparing adalimumab to placebo or to an active comparator.
DATA COLLECTION AND ANALYSIS


We analyzed data on an intention-to-treat basis. We calculated risk ratios (RRs) and corresponding 95% confidence intervals (95% CI) for dichotomous outcomes. The primary outcome was failure to maintain clinical remission. We define clinical remission as a Crohn's Disease Activity Index (CDAI) score of < 150. Secondary outcomes were failure to maintain clinical response, endoscopic remission, endoscopic response, histological remission and adverse events (AEs). We assessed biases using the Cochrane 'Risk of bias' tool. We used GRADE to assess the overall certainty of evidence supporting the primary outcome.
MAIN RESULTS


We included six RCTs (1158 participants). We rated four trials at low risk of bias and two trials at unclear risk of bias. All participants had moderate-to-severe CD that was in clinical remission. Four studies were placebo-controlled (1012 participants). Two studies (70 participants) compared adalimumab to active medication (azathioprine, mesalamine or 6-mercaptopurine) in participants who had an ileocolic resection prior to study enrolment. Adalimumab versus placebo Fifty-nine per cent (252/430) of participants treated with adalimumab failed to maintain clinical remission at 52 to 56 weeks, compared with 86% (217/253) of participants receiving placebo (RR 0.70, 95% CI 0.64 to 0.77; 3 studies, 683 participants; high-certainty evidence). Among those who received prior TNF-α antagonist therapy, 69% (129/186) of adalimumab participants failed to maintain clinical or endoscopic response at 52 to 56 weeks, compared with 93% (108/116) of participants who received placebo (RR 0.76, 95% CI 0.68 to 0.85; 2 studies, 302 participants; moderate-certainty evidence). Fifty-one per cent (192/374) of participants who received adalimumab failed to maintain clinical remission at 24 to 26 weeks, compared with 79% (149/188) of those who received placebo (RR 0.66, 95% CI 0.52 to 0.83; 2 studies, 554 participants; moderate-certainty evidence). Eighty-seven per cent (561/643) of participants who received adalimumab reported an AE compared with 85% (315/369) of participants who received placebo (RR 1.01, 95% CI 0.94 to 1.09; 4 studies, 1012 participants; high-certainty evidence). Serious adverse events were seen in 8% (52/643) of participants who received adalimumab and 14% (53/369) of participants who received placebo (RR 0.56, 95% CI 0.39 to 0.80; 4 studies, 1012 participants; moderate-certainty evidence) and withdrawal due to AEs was reported in 7% (45/643) of adalimumab participants compared to 13% (48/369) of placebo participants (RR 0.59, 95% CI 0.38 to 0.91; 4 studies, 1012 participants; moderate-certainty evidence). Commonly-reported AEs included CD aggravation, arthralgia, nasopharyngitis, urinary tract infections, headache, nausea, fatigue and abdominal pain. Adalimumab versus active comparators No studies reported failure to maintain clinical remission. One study reported on failure to maintain clinical response and endoscopic remission at 104 weeks in ileocolic resection participants who received either adalimumab, azathioprine or mesalamine as post-surgical maintenance therapy. Thirteen per cent (2/16) of adalimumab participants failed to maintain clinical response compared with 54% (19/35) of azathioprine or mesalamine participants (RR 0.23, 95% CI 0.06 to 0.87; 51 participants). Six per cent (1/16) of participants who received adalimumab failed to maintain endoscopic remission, compared with 57% (20/35) of participants who received azathioprine or mesalamine (RR 0.11, 95% CI 0.02 to 0.75; 51 participants; very low-certainty evidence). One study reported on failure to maintain endoscopic response at 24 weeks in ileocolic resection participants who received either adalimumab or 6-mercaptopurine (6-MP) as post-surgical maintenance therapy. Nine per cent (1/11) of adalimumab participants failed to maintain endoscopic remission compared with 50% (4/8) of 6-MP participants (RR 0.18, 95% CI 0.02 to 1.33; 19 participants).
AUTHORS' CONCLUSIONS


Adalimumab is an effective therapy for maintenance of clinical remission in people with quiescent CD. Adalimumab is also effective in those who have previously been treated with TNF-α antagonists. The effect of adalimumab in the post-surgical setting is uncertain. More research is needed in people with recent bowel surgery for CD to better determine treatment plans following surgery. Future research should continue to explore factors that influence initial and subsequent biologic selection for people with moderate-to-severe CD. Studies comparing adalimumab to other active medications are needed, to help determine the optimal maintenance therapy for CD.",2020,"Six per cent (1/16) of participants who received adalimumab failed to maintain endoscopic remission, compared with 57% (20/35) of participants who received azathioprine or mesalamine (RR 0.11, 95% CI 0.02 to 0.75; 51 participants; very low-certainty evidence).","['people with moderate-to-severe CD', ""Crohn's disease"", 'people with quiescent CD', 'participants who had an ileocolic resection prior to study enrolment']","['adalimumab to placebo', 'azathioprine', 'adalimumab', '6-MP', 'adalimumab or 6-mercaptopurine (6-MP', 'TNF-α antagonist therapy', 'adalimumab, azathioprine or mesalamine', 'azathioprine or mesalamine', 'mesalamine', 'Adalimumab', 'Adalimumab versus active comparators', 'adalimumab to active medication (azathioprine, mesalamine or 6-mercaptopurine', 'placebo']","['maintain clinical response', 'maintain clinical or endoscopic response', 'maintain endoscopic remission', ""Crohn's Disease Activity Index (CDAI) score"", 'efficacy and safety', 'maintain clinical remission', 'moderate-certainty evidence) and withdrawal due to AEs', 'failure to maintain clinical response, endoscopic remission, endoscopic response, histological remission and adverse events (AEs', 'CD aggravation, arthralgia, nasopharyngitis, urinary tract infections, headache, nausea, fatigue and abdominal pain', 'failure to maintain clinical remission', 'calculated risk ratios (RRs', 'Serious adverse events']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C1280902', 'cui_str': 'Ileocolic resection'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0127615', 'cui_str': 'mesalamine'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0451071', 'cui_str': ""Crohn's disease activity index""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",,0.562927,"Six per cent (1/16) of participants who received adalimumab failed to maintain endoscopic remission, compared with 57% (20/35) of participants who received azathioprine or mesalamine (RR 0.11, 95% CI 0.02 to 0.75; 51 participants; very low-certainty evidence).","[{'ForeName': 'Cassandra M', 'Initials': 'CM', 'LastName': 'Townsend', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}, {'ForeName': 'Tran M', 'Initials': 'TM', 'LastName': 'Nguyen', 'Affiliation': 'Robarts Clinical Trials, London, Canada.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Cepek', 'Affiliation': 'Schulich School of Medicine & Dentistry, University of Western Ontario, London, Canada.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Abbass', 'Affiliation': 'Schulich School of Medicine & Dentistry, University of Western Ontario, London, Canada.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Parker', 'Affiliation': 'Robarts Clinical Trials, London, Canada.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'MacDonald', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Khanna', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}, {'ForeName': 'Vipul', 'Initials': 'V', 'LastName': 'Jairath', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012877.pub2']
803,31569173,"Effects of a Multimodal Exercise Program Plus Neural Gliding on Postural Control, Pain, and Flexibility of Institutionalized Older Adults: A Randomized, Parallel, and Double-Blind Study.","BACKGROUND AND PURPOSE


The effect of adding neural mobilization to a multimodal program of exercises has not been investigated, despite its potential positive effects. The aim of this study was to compare the acute effects of a multimodal exercise program and neural gliding against a multimodal exercise program only, on pain intensity, gait speed, Timed Up and Go (TUG) test, lower limb flexibility, and static balance of institutionalized older adults.
METHODS


Older adults who were institutionalized (n = 26) were randomized to receive a multimodal exercise program plus neural gliding or a multimodal exercise program only. Both interventions were delivered twice a week for 8 weeks. Participants were assessed for pain, gait velocity, balance, flexibility, and TUG at baseline and postintervention.
RESULTS


A significant main effect of time for pain intensity (F1,24 = 8.95, P = .006), balance (F1,24 = 10.29, P = .004), and gait velocity (F1,24 = 5.51, P = .028) was observed, indicating a positive impact of both interventions. No other significant effects were found (TUG and flexibility; P > .05).
DISCUSSION


A 45-minute multimodal exercise program, twice a week for 8 weeks, has a positive impact on pain intensity, balance, and gait velocity, but neural gliding has no additional benefit. It is unclear whether dose and type of neural mobilization may have had an impact on results. Considering the structural and physiological changes that tend to occur with age, future studies could explore the effects of neural tensioning or of higher doses of neural mobilization.
CONCLUSIONS


This study suggests that adding neural gliding to a multimodal exercise program has no additional benefit.",2020,"A significant main effect of time for pain intensity (F1,24 = 8.95, P = .006), balance (F1,24 = 10.29, P = .004), and gait velocity (F1,24 = 5.51, P = .028) was observed, indicating a positive impact of both interventions.","['institutionalized older adults', 'Institutionalized Older Adults', 'Older adults who were institutionalized (n = 26']","['multimodal exercise program and neural gliding against a multimodal exercise program', 'Multimodal Exercise Program Plus Neural Gliding', 'multimodal exercise program plus neural gliding or a multimodal exercise program only', 'multimodal exercise program']","['pain, gait velocity, balance, flexibility, and TUG at baseline and postintervention', 'gait velocity', 'pain intensity, balance, and gait velocity', 'pain intensity, gait speed, Timed Up and Go (TUG) test, lower limb flexibility, and static balance', 'Postural Control, Pain, and Flexibility', 'time for pain intensity']","[{'cui': 'C0562359', 'cui_str': 'Institutionalized (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.204613,"A significant main effect of time for pain intensity (F1,24 = 8.95, P = .006), balance (F1,24 = 10.29, P = .004), and gait velocity (F1,24 = 5.51, P = .028) was observed, indicating a positive impact of both interventions.","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Mateus', 'Affiliation': 'School of Health Sciences, University of Aveiro, Campus Universitário de Santiago, Portugal.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Rebelo', 'Affiliation': 'Lar Santa Catarina do Reboleiro, Avenida da Ribeirinha, Trancoso, Portugal.'}, {'ForeName': 'Anabela G', 'Initials': 'AG', 'LastName': 'Silva', 'Affiliation': 'School of Health Sciences, University of Aveiro, Campus Universitário de Santiago, Portugal.'}]",Journal of geriatric physical therapy (2001),['10.1519/JPT.0000000000000249']
804,31859559,Responsibly Communicating Delays After Suicides on Railways.,"Background:  By communicating  collision with a person  as a reason for post-suicide railway delays, railway companies may involuntarily communicate to the public that colliding with a train is a suicide method.  Aims:  To compare the impact of the  collision with a person  delay announcement with an announcement about  emergency services  and one about  collision with an animal  (control announcement), we measured suicide-related emotions, associations with suicide, and announcement appreciation.  Method:  A randomized controlled online experiment ( N  = 664) was conducted.  Results:  After exposure to the  collision with a person  announcement, participants were 9.1 times more likely to indicate suicide as the most probable reason for the delay than after the  emergency services  announcement. The emotional impact of both announcements was low. Still, participants reported more anger toward the victim after exposure to the  collision with a person  announcement than after exposure to the  emergency services  announcement. Announcement appreciation was significantly higher after exposure to  collision with a person .  Limitations:  This online experiment may have reflected real-life situations concerning train delays to only a limited extent.  Conclusion:  From the perspective of suicide prevention, the  emergency services  announcement is a more appropriate delay announcement than the  collision with a person  announcement.",2020,"From the perspective of suicide prevention, the  emergency services  announcement is a more appropriate delay announcement than the  collision with a person  announcement.",[],['collision with a person  delay announcement with an announcement about  emergency services  and one about  collision with an animal  (control announcement'],[],[],"[{'cui': 'C0337196', 'cui_str': 'Collision (event)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0003062', 'cui_str': 'Animals'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],664.0,0.0827874,"From the perspective of suicide prevention, the  emergency services  announcement is a more appropriate delay announcement than the  collision with a person  announcement.","[{'ForeName': 'Lonneke', 'Initials': 'L', 'LastName': 'van Leeuwen', 'Affiliation': 'Youth and Risky Behavior Department, Trimbos Institute, Utrecht, The Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Bommelé', 'Affiliation': 'Drug Monitoring and Policy Department, Trimbos Institute, Utrecht, The Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Hoogcarspel', 'Affiliation': 'Safety Department, ProRail, Utrecht, The Netherlands.'}]",Crisis,['10.1027/0227-5910/a000634']
805,31563980,Evaluating the effects of parenting styles dimensions on adolescent drug use: secondary analysis of #Tamojunto randomized controlled trial.,"The present study examined parenting style dimensions (demandingness and responsiveness) as predictors of adolescent drug use and also evaluated whether parenting styles dimensions moderate the effects of the implemented prevention program. 6.391 students in the 7th and 8th grades at 72 Brazilian public schools participated in a three-wave randomized controlled trial to evaluate a school drug-use prevention program. We used structural equation modeling to test if baseline parenting style dimensions (demandingness and responsiveness) would predict the use of drugs (alcohol, binge drinking, cannabis, inhalants, and tobacco) after 21 months. Additionally, we evaluated an interaction version of the above-described model to test if the effect of the prevention program would be moderated by either or both parenting style dimensions. Higher levels of parent demandingness predicted lower chances of adolescent drug use (e.g., Cigarette use OR 0.76, 95% CI 0.64-0.89); responsiveness on the five outcomes showed p value superior to 0.01. The effect of the #Tamojunto intervention is unlikely to be conditioned to either parenting style dimensions on the assessed outcomes.Clinical trial registration Brazilian Register of Clinical Trials (REBEC): #RBR-4mnv5g ( https://www.ensaiosclinicos.gov.br/rg/?q=tamojunto ).",2020,The effect of the #Tamojunto intervention is unlikely to be conditioned to either parenting style dimensions on the assessed outcomes.,['6.391\xa0students in the 7th and 8th grades at 72 Brazilian public schools'],"['Tamojunto intervention', 'school drug-use prevention program', 'parenting styles dimensions']",[],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0557800', 'cui_str': 'Public school (environment)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}]",[],,0.0728107,The effect of the #Tamojunto intervention is unlikely to be conditioned to either parenting style dimensions on the assessed outcomes.,"[{'ForeName': 'Juliana Y', 'Initials': 'JY', 'LastName': 'Valente', 'Affiliation': 'Department of Preventive Medicine, Universidade Federal de São Paulo, Rua Botucatu, 740, São Paulo, Brazil.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Cogo-Moreira', 'Affiliation': 'Department of Psychiatry, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Zila M', 'Initials': 'ZM', 'LastName': 'Sanchez', 'Affiliation': 'Department of Preventive Medicine, Universidade Federal de São Paulo, Rua Botucatu, 740, São Paulo, Brazil. zila.sanchez@unifesp.br.'}]",European child & adolescent psychiatry,['10.1007/s00787-019-01410-9']
806,29220679,Interaction between pre-treatment drug use and heterogeneity of psychiatric diagnosis predicts outcomes in outpatients with co-occurring disorders.,"We examined whether the interaction of baseline stimulant use, assessed by urine drug tests, and type of serious mental illness (SMI) diagnosis predicted stimulant use in a trial of contingency management (CM). The interaction between baseline stimulant use and SMI diagnoses was significant in the overall sample (p=0.002) when controlling for the main effects of treatment condition, baseline stimulant use, and SMI diagnosis. Similar results were also found within the CM sample. Individuals with bipolar disorder were more or less likely, depending on their baseline stimulant-drug test results, to use stimulants during treatment compared to those with other SMI diagnoses.",2018,"The interaction between baseline stimulant use and SMI diagnoses was significant in the overall sample (p=0.002) when controlling for the main effects of treatment condition, baseline stimulant use, and SMI diagnosis.","['Individuals with bipolar disorder', 'outpatients with co-occurring disorders']",[],[],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",[],[],,0.042574,"The interaction between baseline stimulant use and SMI diagnoses was significant in the overall sample (p=0.002) when controlling for the main effects of treatment condition, baseline stimulant use, and SMI diagnosis.","[{'ForeName': 'Oladunni', 'Initials': 'O', 'LastName': 'Oluwoye', 'Affiliation': 'Initiative for Research and Education to Advance Community Health, Washington State University, Spokane, WA, USA; Program of Excellence in Addictions Research, Washington State University, Spokane, WA, USA. Electronic address: oladunni.oluwoye@wsu.edu.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Hirchak', 'Affiliation': 'Initiative for Research and Education to Advance Community Health, Washington State University, Spokane, WA, USA; Program of Excellence in Addictions Research, Washington State University, Spokane, WA, USA. Electronic address: katherine.hirchak@wsu.edu.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Leickly', 'Affiliation': 'Initiative for Research and Education to Advance Community Health, Washington State University, Spokane, WA, USA; Program of Excellence in Addictions Research, Washington State University, Spokane, WA, USA. Electronic address: emily.leickly@wsu.edu.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Skalisky', 'Affiliation': 'Initiative for Research and Education to Advance Community Health, Washington State University, Spokane, WA, USA; Program of Excellence in Addictions Research, Washington State University, Spokane, WA, USA. Electronic address: jordan.skalisky@wsu.edu.'}, {'ForeName': 'Sterling', 'Initials': 'S', 'LastName': 'McPherson', 'Affiliation': 'Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, USA; Program of Excellence in Addictions Research, Washington State University, Spokane, WA, USA; Providence Medical Research Center, Providence Health Care, Spokane, WA, USA. Electronic address: smcpherson05@wsu.edu.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Srebnik', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, WA, USA. Electronic address: Debra.Srebnik@kingcounty.gov.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Roll', 'Affiliation': 'Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, USA; Program of Excellence in Addictions Research, Washington State University, Spokane, WA, USA. Electronic address: johnroll@wsu.edu.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Ries', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, WA, USA. Electronic address: rries@u.washington.edu.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'McDonell', 'Affiliation': 'Initiative for Research and Education to Advance Community Health, Washington State University, Spokane, WA, USA; Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, USA; Program of Excellence in Addictions Research, Washington State University, Spokane, WA, USA. Electronic address: mmcdonell@wsu.edu.'}]",Psychiatry research,['10.1016/j.psychres.2017.11.070']
807,32414563,Impact of an educational intervention in primary care on fasting blood glucose levels and diabetes knowledge among patients with type 2 diabetes mellitus in rural China.,"OBJECTIVE


To assess the impact of an educational intervention for type 2 diabetes mellitus (T2DM) in primary care in rural China, on fasting blood glucose (FBG) level and diabetes knowledge.
METHODS


Patients with T2DM (n = 1,589) in 18 township health centres in three counties in Jiangsu Province were randomly divided into an intervention group receiving educational intervention and follow-up visits, and a control group with standard care. Questionnaires and medical records, including FBG level and diabetes knowledge score, were compared, at baseline and follow-up. Propensity score matching and Difference-in-Difference analysis were used.
RESULTS


The FBG level decreased significantly in the intervention group compared to the control group, DID=-0.53 mmol/l, (CI95 % -0.90 to -0.16). The diabetes knowledge score increased significantly in the intervention group compared to the control group, DID = 0.91, (CI95 % 0.64-1.18). The FBG level and diabetes knowledge score improved significantly in the intervention group in all counties.
CONCLUSIONS


The educational intervention and increased collaboration between hospitals and primary care improved the FBG level and diabetes knowledge score in the intervention group compared to the control group after one year.
PRACTICE IMPLICATIONS


Educational intervention and increased collaboration between hospitals and primary care may improve diabetes care in rural China.",2020,"The educational intervention and increased collaboration between hospitals and primary care improved the FBG level and diabetes knowledge score in the intervention group compared to the control group after one year.
","['Patients with T2DM (n = 1,589) in 18 township health centres in three counties in Jiangsu Province', 'patients with type 2 diabetes mellitus in rural China', 'rural China', 'type 2 diabetes mellitus (T2DM) in primary care in rural China, on fasting blood glucose (FBG) level and diabetes knowledge']","['educational intervention', 'intervention group receiving educational intervention and follow-up visits, and a control group with standard care']","['diabetes knowledge score', 'FBG level and diabetes knowledge score', 'FBG level', 'fasting blood glucose levels and diabetes knowledge', 'Questionnaires and medical records, including FBG level and diabetes knowledge score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",1589.0,0.023265,"The educational intervention and increased collaboration between hospitals and primary care improved the FBG level and diabetes knowledge score in the intervention group compared to the control group after one year.
","[{'ForeName': 'Shaofan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Health Outcomes and Economic Evaluation Research Group, Stockholm Centre for Healthcare Ethics, Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, SE-17177 Stockholm, Sweden; Equity and Health Policy Research Group, Department of Global Public Health, Karolinska Institutet, SE-17177 Stockholm, Sweden; School of Health Policy and Management, Nanjing Medical University, No. 101 Longmian Avenue, Nanjing 211166, China. Electronic address: shaofan.chen@ki.se.'}, {'ForeName': 'Dongfu', 'Initials': 'D', 'LastName': 'Qian', 'Affiliation': 'School of Health Policy and Management, Nanjing Medical University, No. 101 Longmian Avenue, Nanjing 211166, China. Electronic address: dqian@njmu.edu.cn.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Burström', 'Affiliation': 'Health Outcomes and Economic Evaluation Research Group, Stockholm Centre for Healthcare Ethics, Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, SE-17177 Stockholm, Sweden; Equity and Health Policy Research Group, Department of Global Public Health, Karolinska Institutet, SE-17177 Stockholm, Sweden; Center for Health Policy Studies, Nanjing Medical University, No. 101 Longmian Avenue, Nanjing 211166, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Burström', 'Affiliation': 'Equity and Health Policy Research Group, Department of Global Public Health, Karolinska Institutet, SE-17177 Stockholm, Sweden; Center for Health Policy Studies, Nanjing Medical University, No. 101 Longmian Avenue, Nanjing 211166, China.'}]",Patient education and counseling,['10.1016/j.pec.2020.03.010']
808,32414817,Broader impacts of an intervention to transform school environments on student behaviour and school functioning: post hoc analyses from the INCLUSIVE cluster randomised controlled trial.,"BACKGROUND


We have previously reported benefits for reduced bullying, smoking, alcohol and other drug use and mental health from a trial of 'Learning Together', an intervention that aimed to modify school environments and implement restorative practice and a social and emotional skill curriculum.
OBJECTIVES


To conduct post hoc theory-driven analyses of broader impacts.
DESIGN


Cluster randomised trial.
SETTINGS


40 state secondary schools in southern England.
PARTICIPANTS


Students aged 11/12 years at baseline.
OUTCOMES


Student self-reported measures at 24 and 36 months of: cyberbullying victimisation and perpetration; observations of other students perpetrating aggressive behaviours at school; own perpetration of aggressive behaviours in and outside school; perceived lack of safety at school; participation in school disciplinary procedures; truancy and e-cigarette use.
RESULTS


We found evidence of multiple impacts on other health (reduced e-cigarette use, cyberbullying perpetration, perpetration of aggressive behaviours) and educational (reduced participation in school disciplinary procedures and truancy) outcomes.
CONCLUSION


These analyses suggested that the intervention was effective in bringing about a broader range of beneficial outcomes, adding to the evidence that the intervention is a promising approach to promote adolescent health via an intervention that is attractive to schools.
TRIAL REGISTRATION NUMBER


ISRCTN10751359.",2020,"We found evidence of multiple impacts on other health (reduced e-cigarette use, cyberbullying perpetration, perpetration of aggressive behaviours) and educational (reduced participation in school disciplinary procedures and truancy) outcomes.
","['Students aged 11/12 years at baseline', '40 state secondary schools in southern England']",[],"['student behaviour and school functioning', 'aggressive behaviours in and outside school; perceived lack of safety at school; participation in school disciplinary procedures; truancy and e-cigarette use']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0014282', 'cui_str': 'England'}]",[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0424357', 'cui_str': 'Truancy'}, {'cui': 'C4083280', 'cui_str': 'Vape'}]",,0.182719,"We found evidence of multiple impacts on other health (reduced e-cigarette use, cyberbullying perpetration, perpetration of aggressive behaviours) and educational (reduced participation in school disciplinary procedures and truancy) outcomes.
","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bonell', 'Affiliation': 'Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK chris.bonell@lshtm.ac.uk.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Dodd', 'Affiliation': 'Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allen', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Bevilacqua', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McGowan', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Opondo', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Sturgess', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Elbourne', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Warren', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Russell M', 'Initials': 'RM', 'LastName': 'Viner', 'Affiliation': 'Population, Policy and Practice Research Programme, UCL Institute of Child Health, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-031589']
809,27478520,The Method of Randomization for Cluster-Randomized Trials: Challenges of Including Patients with Multiple Chronic Conditions.,"Cluster-randomized clinical trials (CRT) are trials in which the unit of randomization is not a participant but a group (e.g. healthcare systems or community centers). They are suitable when the intervention applies naturally to the cluster (e.g. healthcare policy); when lack of independence among participants may occur (e.g. nursing home hygiene); or when it is most ethical to apply an intervention to all within a group (e.g. school-level immunization). Because participants in the same cluster receive the same intervention, CRT may approximate clinical practice, and may produce generalizable findings. However, when not properly designed or interpreted, CRT may induce biased results. CRT designs have features that add complexity to statistical estimation and inference. Chief among these is the cluster-level correlation in response measurements induced by the randomization. A critical consideration is the experimental unit of inference; often it is desirable to consider intervention effects at the level of the individual rather than the cluster. Finally, given that the number of clusters available may be limited, simple forms of randomization may not achieve balance between intervention and control arms at either the cluster- or participant-level. In non-clustered clinical trials, balance of key factors may be easier to achieve because the sample can be homogenous by exclusion of participants with multiple chronic conditions (MCC). CRTs, which are often pragmatic, may eschew such restrictions. Failure to account for imbalance may induce bias and reducing validity. This article focuses on the complexities of randomization in the design of CRTs, such as the inclusion of patients with MCC, and imbalances in covariate factors across clusters.",2016,"In non-clustered clinical trials, balance of key factors may be easier to achieve because the sample can be homogenous by exclusion of participants with multiple chronic conditions (MCC).","['Patients with Multiple Chronic Conditions', 'participants with multiple chronic conditions (MCC']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3266262', 'cui_str': 'Multi'}]",[],[],,0.0510695,"In non-clustered clinical trials, balance of key factors may be easier to achieve because the sample can be homogenous by exclusion of participants with multiple chronic conditions (MCC).","[{'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Esserman', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, New Haven, Connecticut, USA.'}, {'ForeName': 'Heather G', 'Initials': 'HG', 'LastName': 'Allore', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, New Haven, Connecticut, USA; Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Travison', 'Affiliation': 'Department of Medicine, Harvard Medical School, Cambridge, Massachusetts, USA; Hebrew SeniorLife Institute for Aging Research, Roslindale, Massachusetts, USA.'}]",International journal of statistics in medical research,[]
810,31564620,The Effıcacy of External Cooling and Vibration on Decreasing the Pain of Local Anesthesia Injections During Dental Treatment in Children: A Randomized Controlled Study.,"PURPOSE


This study was performed to assess the efficacy of external cooling and vibration devices on the pain of injections applied to the site of local anesthesia in children during dental treatment.
DESIGN


This study is a randomized controlled trial.
METHODS


This study was conducted with 60 children requiring mandibular baby teeth extraction. The children in the experimental group were anesthetized after cold application, and a vibration device was administered on the application site 2 minutes before and during the anesthesia process, whereas those in the control group were only given local mandibular anesthesia without any other procedure.
FINDINGS


It was found that the mean pain score was lower in the experimental group with a significant difference between the groups (P < .05).
CONCLUSIONS


This study found that the application of external cooling and vibration on the site of local anesthesia had a significant effect on the injection pain experienced by children during dental treatment.",2020,"It was found that the mean pain score was lower in the experimental group with a significant difference between the groups (P < .05).
","['60 children requiring mandibular baby teeth extraction', 'children during dental treatment', 'Children']","['external cooling and vibration devices', 'external cooling and vibration', 'External Cooling and Vibration', 'local mandibular anesthesia without any other procedure']","['Pain of Local Anesthesia Injections', 'mean pain score', 'injection pain']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3266841', 'cui_str': 'Baby Teeth'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0011331', 'cui_str': 'Dental Care'}]","[{'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",,0.0371066,"It was found that the mean pain score was lower in the experimental group with a significant difference between the groups (P < .05).
","[{'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Bilsin', 'Affiliation': 'Gaziantep University, Health Science Faculty, Şehitkamil, Gaziantep, Turkey. Electronic address: elifbilsin-86@hotmail.com.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Güngörmüş', 'Affiliation': 'Gaziantep University, Health Science Faculty, Şehitkamil, Gaziantep, Turkey.'}, {'ForeName': 'Metin', 'Initials': 'M', 'LastName': 'Güngörmüş', 'Affiliation': 'Gaziantep University, Faculty of Dentistry, Şehitkamil, Gaziantep, Turkey.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.06.007']
811,31565750,Hemagglutinin Stalk Antibody Responses Following Trivalent Inactivated Influenza Vaccine Immunization of Pregnant Women and Association With Protection From Influenza Virus Illness.,"BACKGROUND


The conserved, immuno-subdominant influenza virus hemagglutinin (HA) stalk region is a potential universal group-specific influenza virus vaccine epitope. We analyzed antibody responses to H1 hemagglutinin stalk domain (H1/stalk) following trivalent influenza inactivated vaccine (IIV3) immunization in pregnant women, and association with protection against influenza virus illness.
METHODS


One hundred forty-five human immunodeficiency virus (HIV)-uninfected pregnant women (68 IIV3 and 77 placebo recipients) and 140 pregnant women with HIV infection (72 IIV3 and 68 placebo recipients) were independently randomized in placebo-controlled efficacy trials of IIV3. Plasma samples were tested for H1/stalk immunoglobulin G (IgG) and hemagglutination inhibition (HAI) antibodies prevaccination and 1 month postvaccination. Women had weekly surveillance for influenza illness, confirmed by polymerase chain reaction.
RESULTS


Increases in H1/stalk IgG (and HAI) antibody levels were elicited post-IIV3, with responses being higher in HIV-uninfected women than in women living with HIV. Among HIV-uninfected vaccinees, there was no correlation (postvaccination) between H1/stalk and HAI antibody responses, whereas a strong correlation was observed in vaccinees with HIV. The H1/stalk IgG concentration was lower among women developing A/H1N1 illness (85.3 arbitrary units [AU]/mL) than those without A/H1N1 illness (219.6 AU/mL; P = .001). H1/stalk IgG concentration ≥215 AU/mL was associated with 90% lower odds (odds ratio, 0.09; P = .005) of A/H1N1 illness. Also, H1/stalk IgG was significantly lower among women with influenza B illness (93.9 AU/mL) than among their counterparts (215.5 AU/mL) (P = .04); however, no association was observed after adjusting for HAI titers.
CONCLUSIONS


H1/stalk IgG concentration was associated with lower odds for A/H1N1 influenza virus illness, indicating its potential as an epitope for a universal vaccine against group 1 influenza virus.",2020,"FINDINGS


Increases in H1/stalk IgG (and HAI) antibody levels were elicited post-IIV3; with responses being higher in HIV-uninfected than HIV-infected women.","['pregnant women and association with protection from influenza virus illness', 'pregnant women, and association with protection against influenza virus illness', 'One-hundred and forty-five', 'pregnant women']","['placebo', 'trivalent inactivated influenza vaccine immunization', 'placebo-recipients', 'H1 hemagglutinin stalk-domain (H1/stalk) following trivalent influenza inactivated vaccine (IIV3) vaccination']","['H1/stalk IgG', 'H1/stalk IgG concentration', 'H1/stalk IgG (and HAI) antibody levels']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C4316910', 'cui_str': 'Influenzavirus'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C4517577', 'cui_str': '145'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C0935572', 'cui_str': 'Stalkings'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0042212', 'cui_str': 'Vaccines, Killed'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0935572', 'cui_str': 'Stalkings'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",145.0,0.059227,"FINDINGS


Increases in H1/stalk IgG (and HAI) antibody levels were elicited post-IIV3; with responses being higher in HIV-uninfected than HIV-infected women.","[{'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Dhar', 'Affiliation': 'Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Kwatra', 'Affiliation': 'Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Marta C', 'Initials': 'MC', 'LastName': 'Nunes', 'Affiliation': 'Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Cutland', 'Affiliation': 'Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Alane', 'Initials': 'A', 'LastName': 'Izu', 'Affiliation': 'Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Raffael', 'Initials': 'R', 'LastName': 'Nachbagauer', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, USA.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Krammer', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, USA.'}, {'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': 'Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz927']
812,32492293,A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19.,"BACKGROUND


Coronavirus disease 2019 (Covid-19) occurs after exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). For persons who are exposed, the standard of care is observation and quarantine. Whether hydroxychloroquine can prevent symptomatic infection after SARS-CoV-2 exposure is unknown.
METHODS


We conducted a randomized, double-blind, placebo-controlled trial across the United States and parts of Canada testing hydroxychloroquine as postexposure prophylaxis. We enrolled adults who had household or occupational exposure to someone with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure). Within 4 days after exposure, we randomly assigned participants to receive either placebo or hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 additional days). The primary outcome was the incidence of either laboratory-confirmed Covid-19 or illness compatible with Covid-19 within 14 days.
RESULTS


We enrolled 821 asymptomatic participants. Overall, 87.6% of the participants (719 of 821) reported a high-risk exposure to a confirmed Covid-19 contact. The incidence of new illness compatible with Covid-19 did not differ significantly between participants receiving hydroxychloroquine (49 of 414 [11.8%]) and those receiving placebo (58 of 407 [14.3%]); the absolute difference was -2.4 percentage points (95% confidence interval, -7.0 to 2.2; P = 0.35). Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported.
CONCLUSIONS


After high-risk or moderate-risk exposure to Covid-19, hydroxychloroquine did not prevent illness compatible with Covid-19 or confirmed infection when used as postexposure prophylaxis within 4 days after exposure. (Funded by David Baszucki and Jan Ellison Baszucki and others; ClinicalTrials.gov number, NCT04308668.).",2020,"Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported.
","['United States and parts of Canada testing', '821 asymptomatic participants', 'enrolled adults who had household or occupational exposure to someone with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure']","['placebo', 'Hydroxychloroquine', 'placebo or hydroxychloroquine', 'hydroxychloroquine']","['Side effects', 'incidence of new illness compatible with Covid-19', 'incidence of either laboratory-confirmed Covid-19 or illness compatible with Covid-19 within 14 days', 'serious adverse reactions']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0454979', 'cui_str': 'Part of Canada'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0028798', 'cui_str': 'Exposure, Occupational'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0183251', 'cui_str': 'Shield'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",821.0,0.751633,"Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported.
","[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Pullen', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Lofgren', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Okafor', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Alanna A', 'Initials': 'AA', 'LastName': 'Nascene', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Nicol', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Abassi', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Nicole W', 'Initials': 'NW', 'LastName': 'Engen', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Cheng', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'LaBar', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Sylvain A', 'Initials': 'SA', 'LastName': 'Lother', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'MacKenzie', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Drobot', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Marten', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarychanski', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Kelly', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Ilan S', 'Initials': 'IS', 'LastName': 'Schwartz', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Kathy H', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}]",The New England journal of medicine,['10.1056/NEJMoa2016638']
813,27474364,A double blind randomized clinical trial comparing lingualized and fully bilateral balanced posterior occlusion for conventional complete dentures.,"PURPOSE


A lingualized occlusion (LO) for complete dentures reduces lateral inferences and occlusal force contacts and direction; thus, LO is theorized to be more suitable for patients with compromised ridges than fully bilateral balanced articulation (FBBA). However, no studies have yet provided evidence to support LO in edentate patients with compromised alveolar ridges. The purpose of this study was to compare LO and FBBA in edentulous individuals with compromised ridges.
METHODS


Sixty edentulous individuals were randomly allocated into groups and received dentures with either LO or FBBA. Following delivery, several denture-related satisfaction variables were measured using 100mm visual analogue scales; oral health-related quality of life (OHRQoL) was also assessed using the Oral Health Impact Profile (OHIP). Sub-group analyses of the effect of moderate and severe mandibular bone loss were also carried out.
RESULTS


No significant differences were detected between LO and FBBA with the primary outcome. At 6 months, participants with severely atrophied mandibles and FBBA rated their satisfaction with retention of mandibular dentures significantly lower than those with LO (median LO: 86, FBBA: 58.5, p=0.03). They also had significantly lower OHRQoL for the domain of Pain (median LO: 4, FBBA: 5, p=0.02). General satisfaction and total OHIP scores significantly improved between baseline and 6 months only for the LO subjects with severely atrophied mandibles (satisfaction: p=0.003, OHIP total score: p=0.0007).
CONCLUSIONS


The results indicate that the LO occlusal scheme with hard resin artificial teeth is more efficient for patients with severely resorbed mandibular ridges.",2017,"General satisfaction and total OHIP scores significantly improved between baseline and 6 months only for the LO subjects with severely atrophied mandibles (satisfaction: p=0.003, OHIP total score: p=0.0007).
","['patients with compromised ridges than fully bilateral balanced articulation (FBBA', 'Sixty edentulous individuals', 'edentate patients with compromised alveolar ridges', 'patients with severely resorbed mandibular ridges', 'edentulous individuals with compromised ridges']","['dentures with either LO or FBBA', 'lingualized occlusion (LO', 'lingualized and fully bilateral balanced posterior occlusion']","['General satisfaction and total OHIP scores', 'visual analogue scales; oral health-related quality of life (OHRQoL', 'Oral Health Impact Profile (OHIP', 'FBBA rated their satisfaction with retention of mandibular dentures', 'LO and FBBA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332243', 'cui_str': 'Ridging (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0026644', 'cui_str': 'Mouth, Toothless'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure (body structure)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0011394', 'cui_str': 'Dentures'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0232511', 'cui_str': 'Retrusive occlusion'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0029162'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0011394', 'cui_str': 'Dentures'}]",60.0,0.183673,"General satisfaction and total OHIP scores significantly improved between baseline and 6 months only for the LO subjects with severely atrophied mandibles (satisfaction: p=0.003, OHIP total score: p=0.0007).
","[{'ForeName': 'Yasuhiko', 'Initials': 'Y', 'LastName': 'Kawai', 'Affiliation': 'Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, Chiba, Japan. Electronic address: kawai.yasuhiko@nihon-u.ac.jp.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Ikeguchi', 'Affiliation': 'Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, Chiba, Japan.'}, {'ForeName': 'Asako', 'Initials': 'A', 'LastName': 'Suzuki', 'Affiliation': 'Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, Chiba, Japan.'}, {'ForeName': 'Azusa', 'Initials': 'A', 'LastName': 'Kuwashima', 'Affiliation': 'Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, Chiba, Japan.'}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, Chiba, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Matsumaru', 'Affiliation': 'Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, Chiba, Japan.'}, {'ForeName': 'Suguru', 'Initials': 'S', 'LastName': 'Kimoto', 'Affiliation': 'Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, Chiba, Japan.'}, {'ForeName': 'Morio', 'Initials': 'M', 'LastName': 'Iijima', 'Affiliation': 'Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, Chiba, Japan.'}, {'ForeName': 'Jocelyne Sylvia', 'Initials': 'JS', 'LastName': 'Feine', 'Affiliation': 'Oral Health and Society Research Unit, McGill University Faculty of Dentistry, Montreal, Canada.'}]",Journal of prosthodontic research,['10.1016/j.jpor.2016.07.003']
814,31557492,Endocrine effects of the novel ghrelin receptor inverse agonist PF-5190457: Results from a placebo-controlled human laboratory alcohol co-administration study in heavy drinkers.,"Both animal and human work suggests that the ghrelin system may be involved in the mechanisms that regulate the development and maintenance of alcohol use disorder. Previously, in a Phase 1b study, we tested pharmacological blockade of the growth hormone secretagogue receptor 1a (GHS-R1a, also known as the ghrelin receptor), in heavy drinking individuals with PF-5190457, an orally bioavailable, potent and selective GHS-R1a inverse agonist. We report here the effects of PF-5190457 on endocrine blood concentrations of amylin, gastric inhibitory polypeptide, glucagon-like peptide 1, insulin, leptin, pancreatic polypeptide, peptide YY, thyroid stimulating hormone, free triiodothyronine (T3), thyroxine (T4), cortisol, prolactin, and glucose during PF-5190457 dosing, as compared to placebo, in absence of alcohol as well as during an alcohol challenge when PF-5190457 was on steady-state. Blood hormone levels were largely unaffected by PF-5190457, both during dosing and in the context of alcohol challenge. The safety-related relevance of these findings to further develop PF-5190547 in alcohol use disorder is discussed. CLINICALTRIALS.GOV: NCT02039349. This article is part of the special issue on 'Neuropeptides'.",2020,"Blood hormone levels were largely unaffected by PF-5190457, both during dosing and in the context of alcohol challenge.",['controlled human laboratory alcohol co-administration study in heavy drinkers'],"['placebo', 'PF-5190457', 'novel ghrelin receptor inverse agonist']","['endocrine blood concentrations of amylin, gastric inhibitory polypeptide, glucagon-like peptide 1, insulin, leptin, pancreatic polypeptide, peptide YY, thyroid stimulating hormone, free triiodothyronine (T3), thyroxine (T4), cortisol, prolactin, and glucose', 'Blood hormone levels']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4279098', 'cui_str': 'PF-5190457'}, {'cui': 'C0391690', 'cui_str': 'GHSR Protein'}, {'cui': 'C0439850', 'cui_str': 'Inverse (qualifier value)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C1313904', 'cui_str': 'Blood concentration, test strip measurement'}, {'cui': 'C0063684', 'cui_str': 'Amylin'}, {'cui': 'C0017132', 'cui_str': 'Glucose-Dependent Insulin-Releasing Peptide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0030298', 'cui_str': 'Pancreatic Polypeptide Hormone'}, {'cui': 'C0070358', 'cui_str': 'PYY Peptide'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0370097', 'cui_str': 'Free triiodothyronine (substance)'}, {'cui': 'C0202231', 'cui_str': 'Thyroxine measurement (procedure)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0005768'}, {'cui': 'C1287355', 'cui_str': 'Finding of hormone level (finding)'}]",,0.018613,"Blood hormone levels were largely unaffected by PF-5190457, both during dosing and in the context of alcohol challenge.","[{'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Lee', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Farokhnia', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA; Center on Compulsive Behaviors, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Enoch', 'Initials': 'E', 'LastName': 'Cobbina', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Anitha', 'Initials': 'A', 'LastName': 'Saravanakumar', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Xiaobai', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Biostatistics and Clinical Epidemiology Service, Clinical Center, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jillian T', 'Initials': 'JT', 'LastName': 'Battista', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Farinelli', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Akhlaghi', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Leggio', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA; Center on Compulsive Behaviors, National Institutes of Health, Bethesda, MD, USA; Medication Development Program, National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Baltimore, MD, USA; Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University, Providence, RI, USA. Electronic address: lorenzo.leggio@nih.gov.'}]",Neuropharmacology,['10.1016/j.neuropharm.2019.107788']
815,32416072,"Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study.","BACKGROUND


Isocitrate dehydrogenase 1 (IDH1) mutations occur in approximately 13% of patients with intrahepatic cholangiocarcinoma, a relatively uncommon cancer with a poor clinical outcome. The aim of this international phase 3 study was to assess the efficacy and safety of ivosidenib (AG-120)-a small-molecule targeted inhibitor of mutated IDH1-in patients with previously treated IDH1-mutant cholangiocarcinoma.
METHODS


This multicentre, randomised, double-blind, placebo-controlled, phase 3 study included patients from 49 hospitals in six countries aged at least 18 years with histologically confirmed, advanced, IDH1-mutant cholangiocarcinoma who had progressed on previous therapy, and had up to two previous treatment regimens for advanced disease, an Eastern Cooperative Oncology Group performance status score of 0 or 1, and a measurable lesion as defined by Response Evaluation Criteria in Solid Tumors version 1.1. Patients were randomly assigned (2:1) with a block size of 6 and stratified by number of previous systemic treatment regimens for advanced disease to oral ivosidenib 500 mg or matched placebo once daily in continuous 28-day cycles, by means of an interactive web-based response system. Placebo to ivosidenib crossover was permitted on radiological progression per investigator assessment. The primary endpoint was progression-free survival by independent central review. The intention-to-treat population was used for the primary efficacy analyses. Safety was assessed in all patients who had received at least one dose of ivosidenib or placebo. Enrolment is complete; this study is registered with ClinicalTrials.gov, NCT02989857.
FINDINGS


Between Feb 20, 2017, and Jan 31, 2019, 230 patients were assessed for eligibility, and as of the Jan 31, 2019 data cutoff date, 185 patients were randomly assigned to ivosidenib (n=124) or placebo (n=61). Median follow-up for progression-free survival was 6·9 months (IQR 2·8-10·9). Progression-free survival was significantly improved with ivosidenib compared with placebo (median 2·7 months [95% CI 1·6-4·2] vs 1·4 months [1·4-1·6]; hazard ratio 0·37; 95% CI 0·25-0·54; one-sided p<0·0001). The most common grade 3 or worse adverse event in both treatment groups was ascites (four [7%] of 59 patients receiving placebo and nine [7%] of 121 patients receiving ivosidenib). Serious adverse events were reported in 36 (30%) of 121 patients receiving ivosidenib and 13 (22%) of 59 patients receiving placebo. There were no treatment-related deaths.
INTERPRETATION


Progression-free survival was significantly improved with ivosidenib compared with placebo, and ivosidenib was well tolerated. This study shows the clinical benefit of targeting IDH1 mutations in advanced, IDH1-mutant cholangiocarcinoma.
FUNDING


Agios Pharmaceuticals.",2020,Progression-free survival was significantly improved with ivosidenib compared with placebo (median 2·7 months [95% CI 1·6-4·2] vs 1·4 months [1·4-1·6]; hazard ratio 0·37; 95% CI 0·25-0·54; one-sided p<0·0001).,"['mutated IDH1-in patients with previously treated IDH1-mutant cholangiocarcinoma', 'patients from 49 hospitals in six countries aged at least 18 years with histologically confirmed, advanced, IDH1-mutant cholangiocarcinoma who had progressed on previous therapy, and had up to two previous treatment regimens for advanced disease, an Eastern Cooperative Oncology Group performance status score of 0 or 1, and a measurable lesion as defined by Response Evaluation Criteria in Solid Tumors version 1.1', 'Between Feb 20, 2017, and Jan 31, 2019, 230 patients were assessed for eligibility, and as of the Jan 31, 2019 data cutoff date, 185 patients']","['Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy', 'ivosidenib or placebo', 'Placebo', 'oral ivosidenib 500 mg or matched placebo', 'ivosidenib', 'ivosidenib (AG-120)-a small-molecule targeted inhibitor', 'placebo']","['Safety', 'tolerated', 'progression-free survival', 'Median follow-up for progression-free survival', 'adverse event', 'efficacy and safety', 'Progression-free survival', 'Serious adverse events']","[{'cui': 'C0022157', 'cui_str': 'Isocitrate dehydrogenase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C4517617', 'cui_str': '185'}]","[{'cui': 'C4682397', 'cui_str': 'ivosidenib'}, {'cui': 'C0022157', 'cui_str': 'Isocitrate dehydrogenase'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C3827169', 'cui_str': 'AG-120'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",230.0,0.76452,Progression-free survival was significantly improved with ivosidenib compared with placebo (median 2·7 months [95% CI 1·6-4·2] vs 1·4 months [1·4-1·6]; hazard ratio 0·37; 95% CI 0·25-0·54; one-sided p<0·0001).,"[{'ForeName': 'Ghassan K', 'Initials': 'GK', 'LastName': 'Abou-Alfa', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Medical College at Cornell University, New York, NY, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Macarulla', 'Affiliation': ""Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Milind M', 'Initials': 'MM', 'LastName': 'Javle', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Robin K', 'Initials': 'RK', 'LastName': 'Kelley', 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Sam J', 'Initials': 'SJ', 'LastName': 'Lubner', 'Affiliation': 'Department of Medicine, University of Wisconsin Carbone Cancer Center, Madison, WI, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Adeva', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Cleary', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Daniel V', 'Initials': 'DV', 'LastName': 'Catenacci', 'Affiliation': 'Department of Medicine, University of Chicago Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Mitesh J', 'Initials': 'MJ', 'LastName': 'Borad', 'Affiliation': 'Department of Hematology-Oncology, Mayo Clinic Cancer Center, Phoenix, AZ, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'Department of Medical Oncology, UCL Cancer Institute, London, UK.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Harris', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Adrian G', 'Initials': 'AG', 'LastName': 'Murphy', 'Affiliation': 'Department of Oncology-Gastrointestinal Cancer, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Do-Youn', 'Initials': 'DY', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Whisenant', 'Affiliation': 'Medical Oncology and Hematology, Utah Cancer Specialists, Salt Lake City, UT, USA.'}, {'ForeName': 'Maeve A', 'Initials': 'MA', 'LastName': 'Lowery', 'Affiliation': 'Trinity St James Cancer Institute, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Lipika', 'Initials': 'L', 'LastName': 'Goyal', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Rachna T', 'Initials': 'RT', 'LastName': 'Shroff', 'Affiliation': 'Department of Medicine, University of Arizona Cancer Center, Tucson, AZ, USA.'}, {'ForeName': 'Anthony B', 'Initials': 'AB', 'LastName': 'El-Khoueiry', 'Affiliation': 'Department of Medicine, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Fan', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Christina X', 'Initials': 'CX', 'LastName': 'Chamberlain', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Liewen', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Camelia', 'Initials': 'C', 'LastName': 'Gliser', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Shuchi S', 'Initials': 'SS', 'LastName': 'Pandya', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'Division of Cancer Sciences, University of Manchester, Manchester, UK; Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Andrew X', 'Initials': 'AX', 'LastName': 'Zhu', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA; Jiahui International Cancer Center, Jiahui Health, Shanghai, China. Electronic address: azhu@mgh.harvard.edu.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30157-1']
816,32492824,A Practical Approach to Using Integrated Knowledge Translation to Inform a Community-Based Exercise Study.,"BACKGROUND


Our aim was to understand cancer survivor needs prior to, and following the Alberta Cancer Exercise (ACE) pilot randomized trial as a means to inform implementation of a province-wide cancer-specific, community-based exercise program.
METHODS


Questionnaires and semi-structured stakeholder engagement sessions were conducted with cancer survivors to explore preferences, barriers and facilitators/benefits at two timepoints: (1) pre-ACE: prior to initiation of the ACE pilot trial ( n  = 13 survivors and  n  = 5 caregivers); and (2) post-ACE: following participation in the ACE pilot trial ( n  = 20 survivors). Descriptive statistics were used to summarize quantitative data from questionnaires. Stakeholder engagement data were analyzed using a framework analysis approach. Emergent themes were then mapped to actionable outcomes.
RESULTS


Pre-ACE, survivors indicated a preference for exercise programs that were (1) supervised by exercise specialists knowledgeable about cancer, (2) included support from other health care providers, (3) were held in community locations that were easily accessible. Post-ACE, participants identified (1) a lack of exercise counseling from health care providers, (2) the need for earlier introduction of exercise in the care pathway, and (3) supported referral to exercise programming.
CONCLUSIONS


An integrated knowledge translation approach identified actionable outcomes to address survivor needs related to exercise in clinical cancer and community-based contexts.",2020,"Pre-ACE, survivors indicated a preference for exercise programs that were (1) supervised by exercise specialists knowledgeable about cancer, (2) included support from other health care providers, (3) were held in community locations that were easily accessible.",[],['Questionnaires and semi-structured stakeholder engagement sessions'],[],[],"[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4704677', 'cui_str': 'Stakeholder Engagement'}]",[],,0.0432749,"Pre-ACE, survivors indicated a preference for exercise programs that were (1) supervised by exercise specialists knowledgeable about cancer, (2) included support from other health care providers, (3) were held in community locations that were easily accessible.","[{'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Suderman', 'Affiliation': 'Department of Physical Therapy, University of Alberta, 2-50 Corbett Hall, Edmonton, AB T6G 2G4, Canada.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Dolgoy', 'Affiliation': 'Department of Physical Therapy, University of Alberta, 2-50 Corbett Hall, Edmonton, AB T6G 2G4, Canada.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Yurick', 'Affiliation': 'Cross Cancer Institute, Alberta Health Services, 11560 University Avenue, Edmonton, AB T6G 1Z2, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Sellar', 'Affiliation': 'Department of Physical Therapy, University of Alberta, 2-50 Corbett Hall, Edmonton, AB T6G 2G4, Canada.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Nishimura', 'Affiliation': 'Department of Physical Therapy, University of Alberta, 2-50 Corbett Hall, Edmonton, AB T6G 2G4, Canada.'}, {'ForeName': 'S Nicole', 'Initials': 'SN', 'LastName': 'Culos-Reed', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, 2500 University Drive NW, Calgary, AB T2N 1N4, Canada.'}, {'ForeName': 'Anil A', 'Initials': 'AA', 'LastName': 'Joy', 'Affiliation': 'Cross Cancer Institute, Alberta Health Services, 11560 University Avenue, Edmonton, AB T6G 1Z2, Canada.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'McNeely', 'Affiliation': 'Department of Physical Therapy, University of Alberta, 2-50 Corbett Hall, Edmonton, AB T6G 2G4, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph17113911']
817,32416201,Effect of exercise-based cardiac rehabilitation on clinical outcomes in patients with myocardial infarction in the absence of obstructive coronary artery disease (MINOCA).,"BACKGROUND


Myocardial infarction in the absence of obstructive coronary artery disease (MINOCA) is characterized by clinical evidence of myocardial infarction with nonobstructive coronary stenosis on angiography (stenosis < 50%). Studies on the effect that exercise-based cardiac rehabilitation (CR) has on outcomes in MINOCA patients are lacking. Therefore, the purpose of this study was to determine the effect of exercise-based CR on clinical outcomes in patients with MINOCA.
METHODS


A total of 524 participants with MINOCA were recruited in this prospective cohort study from August 2014 to October 2016 and followed for three years. We randomly divided 524 patients into an exercise-based cardiac rehabilitation group (CR+) and a control group (CR-). The CR+ group followed a home-based exercise-training program three times a week during the three years of moderate continuous training (MCT; 65%-75% of peak heart rate) on a bicycle or treadmill.
RESULTS


After one year of follow-up, the Short Form 36 (SF-36) survey showed apparent improvement in the mean physical health score in the CR+ group compared with the CR- group (P < 0.01). During the three-year follow-up, all-cause mortality occurred in 60 individuals, and major adverse cardiovascular events (MACE) happened in 136 individuals. Kaplan-Meier curves indicated a significant reduction in all-cause mortality (log-rank P < 0.05) and MACE (log-rank P < 0.01) in the CR+ group. A multivariate Cox regression analysis indicated that exercise-based CR was associated with a significant reduction in all-cause mortality (hazard ratio [HR] = 0.483; 95% confidence interval [CI], 0.279-0.818; P < 0.01) and MACE (HR = 0.574; 95% CI, 0.403-0.827; P < 0.001).
CONCLUSIONS


A long-term exercise-based CR program was associated with superior physical health and a significant reduction in all-cause mortality and MACE in patients with MINOCA.",2020,Kaplan-Meier curves indicated a significant reduction in all-cause mortality (log-rank P < 0.05) and MACE (log-rank P < 0.01) in the CR+ group.,"['524 patients into an', 'patients with myocardial infarction in the absence of obstructive coronary artery disease (MINOCA', '524 participants with MINOCA were recruited in this prospective cohort study from August 2014 to October 2016 and followed for three years', 'patients with MINOCA']","['exercise-based cardiac rehabilitation group (CR+) and a control group (CR', 'bicycle or treadmill', 'exercise-based cardiac rehabilitation (CR', 'exercise-based CR', 'exercise-based cardiac rehabilitation', 'CR']","['cause mortality', 'mean physical health score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",524.0,0.0357636,Kaplan-Meier curves indicated a significant reduction in all-cause mortality (log-rank P < 0.05) and MACE (log-rank P < 0.01) in the CR+ group.,"[{'ForeName': 'Chao-Jie', 'Initials': 'CJ', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, The First Hospital of Jiaxing, The Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang 314001, China.'}, {'ForeName': 'Chun-Yan', 'Initials': 'CY', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, The First Hospital of Jiaxing, The Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang 314001, China.'}, {'ForeName': 'Yu-Juan', 'Initials': 'YJ', 'LastName': 'Zhu', 'Affiliation': 'Department of Cardiology, The First Hospital of Jiaxing, The Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang 314001, China.'}, {'ForeName': 'Zhuo-Xuan', 'Initials': 'ZX', 'LastName': 'Zou', 'Affiliation': 'Department of Cardiology, The First Hospital of Jiaxing, The Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang 314001, China.'}, {'ForeName': 'Shi-Jun', 'Initials': 'SJ', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The First Hospital of Jiaxing, The Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang 314001, China.'}, {'ForeName': 'Chang-Lin', 'Initials': 'CL', 'LastName': 'Zhai', 'Affiliation': 'Department of Cardiology, The First Hospital of Jiaxing, The Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang 314001, China.'}, {'ForeName': 'Hui-Lin', 'Initials': 'HL', 'LastName': 'Hu', 'Affiliation': 'Department of Cardiology, The First Hospital of Jiaxing, The Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang 314001, China. Electronic address: huhuilin1979@sohu.com.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.05.019']
818,31403944,Exercise Training in Amnestic Mild Cognitive Impairment: A One-Year Randomized Controlled Trial.,"BACKGROUND


The current evidence is inconclusive to support the benefits of aerobic exercise training (AET) for preventing neurocognitive decline in patients with amnestic mild cognitive impairment (aMCI).
OBJECTIVE


To examine the effect of a progressive, moderate-to-high intensity AET program on memory and executive function, brain volume, and cortical amyloid-β (Aβ) plaque deposition in aMCI patients.
METHODS


This is a proof-of-concept trial that randomized 70 aMCI patients to 12 months of AET or stretching and toning (SAT, active control) interventions. Primary neuropsychological outcomes were assessed by using the California Verbal Learning Test-second edition (CVLT-II) and the Delis-Kaplan Executive Function System (D-KEFS). Secondary outcomes were the global and hippocampal brain volumes and the mean cortical and precuneus Aβ deposition.
RESULTS


Baseline cognitive scores were similar between the groups. Memory and executive function performance improved over time but did not differ between the AET and SAT groups. Brain volume decreased and precuneus Aβ plaque deposition increased over time but did not differ between the groups. Cardiorespiratory fitness was significantly improved in the AET compared with SAT group. In amyloid positive patients, AET was associated with reduced hippocampal atrophy when compared with the SAT group.
CONCLUSION


The AET and SAT groups both showed evidence of slightly improved neuropsychological scores in previously sedentary aMCI patients. However, these interventions did not prevent brain atrophy or increases in cortical Aβ deposition over 12 months. In amyloid positive patients, AET reduced hippocampal atrophy when compared with the SAT group.",2019,Brain volume decreased and precuneus,"['aMCI patients', 'Amnestic Mild Cognitive Impairment', 'patients with amnestic mild cognitive impairment (aMCI']","['Exercise Training', 'aerobic exercise training (AET', 'AET or stretching and toning (SAT, active control) interventions']","['global and hippocampal brain volumes and the mean cortical and precuneus', 'reduced hippocampal atrophy', 'California Verbal Learning Test-second edition (CVLT-II) and the Delis-Kaplan Executive Function System (D-KEFS', 'memory and executive function, brain volume, and cortical amyloid-β (Aβ) plaque deposition', 'hippocampal atrophy', 'Memory and executive function performance', 'plaque deposition', 'neuropsychological scores', 'Cardiorespiratory fitness', 'cortical Aβ deposition', 'Brain volume decreased and precuneus']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0629582', 'cui_str': 'AETS'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0589055', 'cui_str': 'TOMAL'}, {'cui': 'C0441795', 'cui_str': 'Second edition (qualifier value)'}, {'cui': 'C4505413', 'cui_str': 'Delis-Kaplan Executive Function System'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0333562', 'cui_str': 'Deposition (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",70.0,0.124384,Brain volume decreased and precuneus,"[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tarumi', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Rossetti', 'Affiliation': 'Departments of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Binu P', 'Initials': 'BP', 'LastName': 'Thomas', 'Affiliation': 'Departments of Advanced Imaging Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Harris', 'Affiliation': 'Departments of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Benjamin Y', 'Initials': 'BY', 'LastName': 'Tseng', 'Affiliation': 'Department of Health and Kinesiology, The University of Texas at Tyler, Tyler, TX, USA.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Turner', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.'}, {'ForeName': 'Ciwen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.'}, {'ForeName': 'Zohre', 'Initials': 'Z', 'LastName': 'German', 'Affiliation': 'Departments of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Martin-Cook', 'Affiliation': 'Departments of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Stowe', 'Affiliation': 'Departments of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Kyle B', 'Initials': 'KB', 'LastName': 'Womack', 'Affiliation': 'Departments of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Mathews', 'Affiliation': 'Departments of Radiology, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Diana R', 'Initials': 'DR', 'LastName': 'Kerwin', 'Affiliation': ""Institute for Texas Alzheimer's and Memory Disorders, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Hynan', 'Affiliation': 'Departments of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Diaz-Arrastia', 'Affiliation': 'Departments of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Hanzhang', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Departments of Advanced Imaging Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'C Munro', 'Initials': 'CM', 'LastName': 'Cullum', 'Affiliation': 'Departments of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-181175']
819,26803560,Comparison of patient-reported outcomes between immediately and conventionally loaded mandibular two-implant overdentures: A preliminary study.,"PURPOSE


The aim of this preliminary study is to compare patient-reported outcomes between immediately and conventionally loaded mandibular two-implant overdentures retained by magnetic attachments.
METHODS


Nineteen participants with edentulous mandibles were randomly assigned into either an immediate loading group (immediate group) or a conventional loading group (conventional group). Each participant received 2 implants in the inter-foraminal region by means of flapless surgery. Prostheses in the immediate and conventional groups were loaded using magnetic attachments on the same day as implant placement or 3 months after surgery, respectively. All participants completed questionnaires (the Japanese version of the Oral Health Impact Profile for edentulous [OHIP-EDENT-J], the patient's denture assessment [PDA], and general satisfaction) before implant placement (baseline) and 1, 2, 3, 4, 5, 6, and 12 months after surgery. The median differences between baseline and each monthly score were compared using the Mann-Whitney U test. The differences in median and 95% confidence interval between two groups were analyzed.
RESULTS


The immediate group showed slightly lower OHIP-EDENT-J summary score at 1 and 3 months than the conventional group (P=0.09). In the lower denture domain of PDA, the immediate group showed a statistically higher score at 3 months (P=0.04). There was no statistically significant difference in general satisfaction between the two groups.
CONCLUSIONS


Based on this preliminary study, immediate loading of mandibular two-implant overdentures with magnetic attachments tends to improve oral health-related quality of life and patient assessment earlier than observed with a conventional loading protocol.",2016,The immediate group showed slightly lower OHIP-EDENT-J summary score at 1 and 3 months than the conventional group (P=0.09).,['Nineteen participants with edentulous mandibles'],['immediate loading group (immediate group) or a conventional loading group (conventional group'],"['general satisfaction', 'oral health-related quality of life', 'slightly lower OHIP-EDENT-J summary score']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C3853359', 'cui_str': 'Edentulous mandible'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0029162'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0750482', 'cui_str': 'Slightly (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",19.0,0.121975,The immediate group showed slightly lower OHIP-EDENT-J summary score at 1 and 3 months than the conventional group (P=0.09).,"[{'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Omura', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Kanazawa', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo, Japan. Electronic address: m.kanazawa.gerd@tmd.ac.jp.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sato', 'Affiliation': 'Department of Implant Dentistry, School of Dentistry, Showa University, Tokyo, Japan.'}, {'ForeName': 'Shohei', 'Initials': 'S', 'LastName': 'Kasugai', 'Affiliation': 'Oral Implantology and Regenerative Dental Medicine, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Minakuchi', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo, Japan.'}]",Journal of prosthodontic research,['10.1016/j.jpor.2015.12.010']
820,31989069,The Equivalence of Video Self-review Versus Debriefing After Simulation: Can Faculty Resources Be Reallocated?,"Introduction


Traditional simulation debriefing is both time- and resource-intensive. Shifting the degree of primary learning responsibility from the faculty to the learner through self-guided learning has received greater attention as a means of reducing this resource intensity. The aim of the study was to determine if video-assisted self-debriefing, as a form of self-guided learning, would have equivalent learning outcomes compared to standard debriefing.
Methods


This randomized cohort study consisting of 49 PGY-1 to -3 emergency medicine residents compared performance after video self-assessment utilizing an observer checklist versus standard debriefing for simulated emergency department procedural sedation (EDPS). The primary outcome measure was performance on the second EDPS scenario.
Results


Independent-samples t-test found that both control (standard debrief) and intervention (video self-assessment) groups demonstrated significantly increased scores on Scenario 2 (standard-t(40) = 2.20, p < 0.05; video-t(45) = 3.88, p < 0.05). There was a large and significant positive correlation between faculty and resident self-evaluation (r = 0.70, p < 0.05). There was no significant difference between faculty and residents self-assessment mean scores (t(24) = 1.90, p = 0.07).
Conclusions


Residents receiving feedback on their performance via video-assisted self-debriefing improved their performance in simulated EDPS to the same degree as with standard faculty debriefing. Video-assisted self-debriefing is a promising avenue for leveraging the benefits of simulation-based training with reduced resource requirements.",2020,"There was no significant difference between faculty and residents self-assessment mean scores (t(24) = 1.90, p = 0.07).
",['49 PGY-1 to -3 emergency medicine residents'],"['Video-assisted self-debriefing', 'video-assisted self-debriefing', 'Video Self-review Versus Debriefing', 'video self-assessment utilizing an observer checklist versus standard debriefing for simulated emergency department procedural sedation (EDPS']","['faculty and residents self-assessment mean scores', 'performance on the second EDPS scenario']","[{'cui': 'C0013964', 'cui_str': 'Emergency Medicine'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment (Psychology)'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]","[{'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment (Psychology)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}]",,0.0328326,"There was no significant difference between faculty and residents self-assessment mean scores (t(24) = 1.90, p = 0.07).
","[{'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Tudor', 'Affiliation': 'Department of Emergency Medicine University of Illinois College of Medicine at Peoria Peoria IL.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Podolej', 'Affiliation': 'Department of Emergency Medicine University of Illinois College of Medicine at Peoria Peoria IL.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Willemsen-Dunlap', 'Affiliation': 'OSF Healthcare Saint Francis Medical Center Peoria IL.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Lau', 'Affiliation': 'Department of Emergency Medicine University of Illinois College of Medicine at Peoria Peoria IL.'}, {'ForeName': 'Jessica D', 'Initials': 'JD', 'LastName': 'Svendsen', 'Affiliation': 'Jump Trading Simulation and Education Center OSF Healthcare System Peoria IL.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'McGarvey', 'Affiliation': 'Jump Trading Simulation and Education Center OSF Healthcare System Peoria IL.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Vozenilek', 'Affiliation': 'Department of Emergency Medicine University of Illinois College of Medicine at Peoria Peoria IL.'}, {'ForeName': 'Lisa T', 'Initials': 'LT', 'LastName': 'Barker', 'Affiliation': 'Department of Emergency Medicine University of Illinois College of Medicine at Peoria Peoria IL.'}]",AEM education and training,['10.1002/aet2.10372']
821,27067867,Influence of guidance concept in complete dentures on oral health related quality of life - Canine guidance vs. bilateral balanced occlusion.,"PURPOSE


To compare the impact of canine guided vs. bilateral balanced occlusion on oral health related quality of life (OHRQoL) as a patient-reported outcome measure.
METHODS


In this randomized single-blind crossover trial, 19 patients have been provided with new complete dentures in the maxilla and mandible. OHRQoL was assessed using the 49-item Oral Health Impact Profile (OHIP-49) before the start of the prosthodontic treatment (B), 3 months after insertion of the new dentures (T1), and 3 months after rework into the alternative concept (T2). Multilevel mixed-effect linear regression models were computed to determine the effect provided by the new set of dentures and the specific impact of the occlusal concept on OHRQoL using summary scores of the OHIP-49 and of a 19-items subset specific for edentulous patients (OHIP-EDENT).
RESULTS


At baseline, participants' OHRQoL was substantially impaired indicated by an average OHIP-49 score of 42.1 points and an OHIP-EDENT score of 21.1 points. The effect of provision of a new set of complete dentures was a statistically significant decrease of 8.3 points (OHIP-49) and 4.0 points (OHIP-EDENT), respectively, representing a clinically relevant improvement in OHRQoL. When wearing dentures with bilateral balanced occlusion, participants showed on average 1.6 points higher OHIP-49 scores and 0.9 points higher OHIP-EDENT scores compared to canine guided dentures. This effect of the occlusal concept was neither statistically nor clinically significant.
CONCLUSIONS


Both investigated occlusal concepts for complete dentures were comparable in their effect on patients' perceptions with none being considerably superior in terms of OHRQoL.",2016,Both investigated occlusal concepts for complete dentures were comparable in their effect on patients' perceptions with none being considerably superior in terms of OHRQoL.,['19 patients have been provided with new complete dentures in the maxilla and mandible'],"['canine guided vs. bilateral balanced occlusion', 'OHRQoL']","['average OHIP-49 score', 'oral health related quality of life (OHRQoL', 'OHIP-49 scores', 'OHRQoL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0011455', 'cui_str': 'Denture, Complete'}, {'cui': 'C0024947', 'cui_str': 'Maxillary Bone'}, {'cui': 'C0024687', 'cui_str': 'Mandible'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0029162'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",19.0,0.243947,Both investigated occlusal concepts for complete dentures were comparable in their effect on patients' perceptions with none being considerably superior in terms of OHRQoL.,"[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Schierz', 'Affiliation': 'Department of Prosthodontics and Materials Science, University of Leipzig, Liebigstr. 12, 04103 Leipzig, Germany. Electronic address: oliver.schierz@medizin.uni-leipzig.de.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Reissmann', 'Affiliation': 'Department of Prosthetic Dentistry, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany. Electronic address: d.reissmann@uke.de.'}]",Journal of prosthodontic research,['10.1016/j.jpor.2016.03.005']
822,32026447,Relationship of White Matter Lesions with Intracerebral Hemorrhage Expansion and Functional Outcome: MISTIE II and CLEAR III.,"BACKGROUND/OBJECTIVE


Intracerebral hemorrhage (ICH) patients commonly have concomitant white matter lesions (WML) which may be associated with poor outcome. We studied if WML affects hematoma expansion (HE) and post-stroke functional outcome in a post hoc analysis of patients from randomized controlled trials.
METHODS


In ICH patients from the clinical trials MISTIE II and CLEAR III, WML grade on diagnostic computed tomography (dCT) scan (dCT, < 24 h after ictus) was assessed using the van Swieten scale (vSS, range 0-4). The primary outcome for HE was > 33% or > 6 mL ICH volume increase from dCT to the last pre-randomization CT (< 72 h of dCT). Secondary HE outcomes were: absolute ICH expansion, > 10.4 mL total clot volume increase, and a subgroup analysis including patients with dCT < 6 h after ictus using the primary HE definition of > 33% or > 6 mL ICH volume increase. Poor functional outcome was assessed at 180 days and defined as modified Rankin Scale (mRS) ≥ 4, with ordinal mRS as a secondary endpoint.
RESULTS


Of 635 patients, 55% had WML grade 1-4 at dCT (median 2.2 h from ictus) and 13% had subsequent HE. WML at dCT did not increase the odds for primary or secondary HE endpoints (P ≥ 0.05) after adjustment for ICH volume, intraventricular hemorrhage volume, warfarin/INR > 1.5, ictus to dCT time in hours, age, diabetes mellitus, and thalamic ICH location. WML increased the odds for having poor functional outcome (mRS ≥ 4) in univariate analyses (vSS 4; OR 4.16; 95% CI 2.54-6.83; P < 0.001) which persisted in multivariable analyses after adjustment for HE and other outcome risk factors.
CONCLUSIONS


Concomitant WML does not increase the odds for HE in patients with ICH but increases the odds for poor functional outcome.
CLINICAL TRIAL REGISTRATION


http://www.clinicaltrials.gov trial-identifiers: NCT00224770 and NCT00784134.",2020,"WML at dCT did not increase the odds for primary or secondary HE endpoints (P ≥ 0.05) after adjustment for ICH volume, intraventricular hemorrhage volume, warfarin/INR > 1.5, ictus to dCT time in hours, age, diabetes mellitus, and thalamic ICH location.",['patients with dCT'],['WML'],"['absolute ICH expansion, ', 'ICH volume, intraventricular hemorrhage volume, warfarin/INR\u2009>\u20091.5, ictus to dCT time in hours, age, diabetes mellitus, and thalamic ICH location', 'Poor functional outcome']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage (disorder)'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0525032', 'cui_str': 'INR'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",635.0,0.141451,"WML at dCT did not increase the odds for primary or secondary HE endpoints (P ≥ 0.05) after adjustment for ICH volume, intraventricular hemorrhage volume, warfarin/INR > 1.5, ictus to dCT time in hours, age, diabetes mellitus, and thalamic ICH location.","[{'ForeName': 'Björn M', 'Initials': 'BM', 'LastName': 'Hansen', 'Affiliation': 'Department of Clinical Sciences Lund, Neurology, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Ullman', 'Affiliation': ""Division of Neurology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA. nlullman@gmail.com.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Muschelli', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Norrving', 'Affiliation': 'Department of Clinical Sciences Lund, Neurology, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dlugash', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Radhika', 'Initials': 'R', 'LastName': 'Avadhani', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Issam', 'Initials': 'I', 'LastName': 'Awad', 'Affiliation': 'Department of Neurosurgery, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Zuccarello', 'Affiliation': 'Department of Neurosurgery, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Wendy C', 'Initials': 'WC', 'LastName': 'Ziai', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hanley', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Thompson', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Lindgren', 'Affiliation': 'Department of Clinical Sciences Lund, Neurology, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurocritical care,['10.1007/s12028-020-00916-4']
823,32419378,An oral health optimized diet reduces the load of potential cariogenic and periodontal bacterial species in the supragingival oral plaque: A randomized controlled pilot study.,"This study aimed to investigate the effects of an oral health optimized diet on the composition of the supragingival oral plaque in a randomized controlled trial. Participants of the standard diet group (n = 5) had a diet high in processed carbohydrates and did not change their dietary behavior during the observation. The healthy diet group (n = 9) had to change the diet after 2 weeks from a diet high in processed carbohydrates to a diet low in carbohydrates, rich in omega-3 fatty acids, rich in vitamins C and D, antioxidants and fiber for 4 weeks. Saliva and supragingival plaque samples were taken at the end of week two and eight of the observation period to investigate the composition of microbiota in saliva and supragingival plaque. Data were subjected to an exploratory analysis to identify significant differences. Statistically significant differences were only found in the healthy diet group between the baseline (week 2) and the final sample (week 8) for specific species in plaque and saliva samples. A reduction of the total counts of Streptococcus mitis group, Granulicatella adiacens, Actinomyces spp., and Fusobacterium spp. was found in plaque samples of the healthy diet group. In saliva samples of the healthy diet group, the total counts of Actinomyces spp. and Capnocytophaga spp. decreased. A diet low in carbohydrates, rich in omega-3 fatty acids, rich in vitamins C and D, and rich in fiber reduced Streptococcus mitis group, Granulicatella adiacens, Actinomyces spp., and Fusobacterium spp. in the supragingival plaque.",2020,"A reduction of the total counts of Streptococcus mitis group, Granulicatella adiacens, Actinomyces spp., and Fusobacterium spp. was found in plaque samples of the healthy diet group.",[],"['diet high in processed carbohydrates', 'diet high in processed carbohydrates to a diet low in carbohydrates, rich in omega-3 fatty acids, rich in vitamins C and D, antioxidants and fiber for 4\xa0weeks', 'oral health optimized diet']",['total counts of Actinomyces spp'],[],"[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0001250', 'cui_str': 'Actinomyces'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}]",,0.0238515,"A reduction of the total counts of Streptococcus mitis group, Granulicatella adiacens, Actinomyces spp., and Fusobacterium spp. was found in plaque samples of the healthy diet group.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Tennert', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Ann-Christin', 'Initials': 'AC', 'LastName': 'Reinmuth', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, Center for Dental Medicine, Medical Center - University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Bremer', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, Center for Dental Medicine, Medical Center - University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Al-Ahmad', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, Center for Dental Medicine, Medical Center - University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Lamprini', 'Initials': 'L', 'LastName': 'Karygianni', 'Affiliation': 'Clinic of Preventive Dentistry, Periodontology and Cariology, Center of Dental Medicine, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Elmar', 'Initials': 'E', 'LastName': 'Hellwig', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, Center for Dental Medicine, Medical Center - University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Kirstin', 'Initials': 'K', 'LastName': 'Vach', 'Affiliation': 'Department of Medical Biometry and Statistics, Medical Center - University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Ratka-Krüger', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, Center for Dental Medicine, Medical Center - University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Wittmer', 'Affiliation': 'Department of Microbiology and Hygiene, Institute of Medical Microbiology and Hygiene, Medical Center - University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Johan Peter', 'Initials': 'JP', 'LastName': 'Woelber', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, Center for Dental Medicine, Medical Center - University of Freiburg, Freiburg im Breisgau, Germany.'}]",MicrobiologyOpen,['10.1002/mbo3.1056']
824,32053243,Randomised simulation trial found an association between rescuers' height and weight and chest compression quality during paediatric resuscitation.,"AIM


Our aim was to examine the relationship between rescuers' anthropometric data and chest compression quality during paediatric resuscitation training.
METHODS


This study focused on 224 medical students (53% women) who performed 2 minutes of paediatric resuscitation at the Medical University of Vienna, Austria: 116 on a baby manikin and 108 on an adolescent manikin. Skill Reporter software measured chest compression quality by recording compression depth, frequency, hand position and complete recoil. The participants' height, weight and body mass index (BMI) were recorded.
RESULTS


Participants with a lower BMI achieved higher total chest compression scores on both the baby and adolescent manikins than participants with a higher BMI. The latter were more likely to exceed the correct compression depth and not achieve complete chest recoil in the adolescent manikin. When it came to the baby manikin, the female participants achieved better chest recoil and the males achieved a higher number of compressions at the correct rate. Males also achieved better chest recoil with the adolescent manikins. Being tall only correlated with incomplete recoil in the adolescent manikin.
CONCLUSION


The results indicate that anthropometric variables were associated with chest compression quality in paediatric patients and should be considered by future education programmes.",2020,"RESULTS


Participants with a lower BMI achieved higher total chest compression scores on both the baby and adolescent manikins than participants with a higher BMI.","['paediatric resuscitation', 'paediatric patients', '224 medical students (53% women) who performed two minutes of paediatric resuscitation at the Medical University of Vienna, Austria: 116 on a baby manikin and 108 on an adolescent manikin']",[],"['correct compression depth', 'chest compression quality by recording compression depth, frequency, hand position and complete recoil', 'total chest compression scores', 'height, weight and body mass index (BMI', 'chest compression quality']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],"[{'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",224.0,0.0156304,"RESULTS


Participants with a lower BMI achieved higher total chest compression scores on both the baby and adolescent manikins than participants with a higher BMI.","[{'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Bibl', 'Affiliation': 'Division of Neonatology, Paediatric Intensive Care and Neuropaediatrics, Department of Paediatrics, Comprehensive Center for Paediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gröpel', 'Affiliation': 'Department of Applied Psychology: Work, Education and Economy, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Berger', 'Affiliation': 'Division of Neonatology, Paediatric Intensive Care and Neuropaediatrics, Department of Paediatrics, Comprehensive Center for Paediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Georg M', 'Initials': 'GM', 'LastName': 'Schmölzer', 'Affiliation': 'Neonatal Research Unit, Centre for the Studies of Asphyxia and Resuscitation, Royal Alexandra Hospital, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Olischar', 'Affiliation': 'Division of Neonatology, Paediatric Intensive Care and Neuropaediatrics, Department of Paediatrics, Comprehensive Center for Paediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wagner', 'Affiliation': 'Division of Neonatology, Paediatric Intensive Care and Neuropaediatrics, Department of Paediatrics, Comprehensive Center for Paediatrics, Medical University of Vienna, Vienna, Austria.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15229']
825,32065769,Effects of Exercise Therapy Dosing Schedule on Impaired Cardiorespiratory Fitness in Patients With Primary Breast Cancer: A Randomized Controlled Trial.,"BACKGROUND


Current exercise guidelines for clinical populations recommend an exercise therapy (ET) prescription of fixed intensity (moderate), duration (40-50 minutes per session), and volume (120-160 min/wk). A critical overarching element of exercise programming that has received minimal attention is dose scheduling. We investigated the tolerability and efficacy of 2 exercise training dose regimens on cardiorespiratory fitness and patient-reported outcomes in patients with posttreatment primary breast cancer.
METHODS


Using a parallel-group randomized trial, we randomly allocated 174 postmenopausal patients (2.8 years after adjuvant therapy) with impaired peak oxygen consumption (VO 2 peak) to 1 of 2 supervised exercise training interventions delivered with a standard linear (LET) (fixed dose intensity per session for 160 min/wk) or nonlinear (NLET) (variable dose intensity per session for ≈120 min/wk) schedule compared with a stretching attention control group for 16 consecutive weeks. Stretching was matched to exercise dosing arms on the basis of location, frequency, duration, and treatment length. The primary end point was change in VO 2 peak (mL O 2 ·kg -1 ·min -1 ) from baseline to after intervention. Secondary end points were patient-reported outcomes, tolerability, and safety.
RESULTS


No serious adverse events were observed. Mean attendance was 64%, 75%, and 80% for attention control, LET, and NLET, respectively. In intention-to-treat analysis, VO 2 peak increased 0.6±1.7 mL O 2 ·kg -1 ·min -1  ( P =0.05) and 0.8±1.8 mL O 2 ·kg -1 ·min -1  ( P =0.07) in LET and NLET, respectively, compared with attention control. Change in VO 2 peak ranged from -2.7 to 4.1 mL O 2 ·kg -1 ·min -1  and from -3.6 to 5.1 mL O 2 ·kg -1 ·min -1  in LET and NLET, respectively. Approximately 40% of patients in both exercise dosing regimens were classified as VO 2 peak responders (ie, Δ ≥1.32 mL O 2 ·kg -1 ·min -1 ). NLET improved all patient-reported outcomes compared with attention control.
CONCLUSIONS


Short-term exercise training, independently of dosing schedule, is associated with modest improvements in cardiorespiratory fitness in patients previously treated for early-stage breast cancer.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT01186367.",2020,"In intention-to-treat analysis, VO 2 peak increased 0.6±1.7","['patients with posttreatment primary breast cancer', 'Patients With Primary Breast Cancer', '174 postmenopausal patients (2.8 years after', 'patients previously treated for early-stage breast cancer']","['adjuvant therapy) with impaired peak oxygen consumption (VO 2 peak) to 1 of 2 supervised exercise training interventions delivered with a standard linear (LET) (fixed dose intensity per session for 160 min/wk) or nonlinear (NLET) (variable dose intensity per session for ≈120 min/wk) schedule compared with a stretching attention control', '2 exercise training', 'Short-term exercise training', 'Exercise Therapy', 'NLET']","['change in VO 2 peak', 'serious adverse events', 'tolerability, and safety', 'Cardiorespiratory Fitness', 'tolerability and efficacy', 'cardiorespiratory fitness', 'Mean attendance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}]","[{'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",174.0,0.279428,"In intention-to-treat analysis, VO 2 peak increased 0.6±1.7","[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Scott', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY (J.M.S., C.T.D., A.F.Y., D.C., C.C., C.C., M.G.M., L.W.J.).'}, {'ForeName': 'Samantha M', 'Initials': 'SM', 'LastName': 'Thomas', 'Affiliation': 'Duke University Medical Center, Durham, NC (S.M.T., J.E.H., P.S.D., M.G.K.).'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Peppercorn', 'Affiliation': 'Weill Cornell Medical College, New York, NY (J.M.S., C.T.D., L.W.J.).'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Herndon', 'Affiliation': 'Duke University Medical Center, Durham, NC (S.M.T., J.E.H., P.S.D., M.G.K.).'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke University Medical Center, Durham, NC (S.M.T., J.E.H., P.S.D., M.G.K.).'}, {'ForeName': 'Michel G', 'Initials': 'MG', 'LastName': 'Khouri', 'Affiliation': 'Duke University Medical Center, Durham, NC (S.M.T., J.E.H., P.S.D., M.G.K.).'}, {'ForeName': 'Chau T', 'Initials': 'CT', 'LastName': 'Dang', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY (J.M.S., C.T.D., A.F.Y., D.C., C.C., C.C., M.G.M., L.W.J.).'}, {'ForeName': 'Anthony F', 'Initials': 'AF', 'LastName': 'Yu', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY (J.M.S., C.T.D., A.F.Y., D.C., C.C., C.C., M.G.M., L.W.J.).'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Catalina', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY (J.M.S., C.T.D., A.F.Y., D.C., C.C., C.C., M.G.M., L.W.J.).'}, {'ForeName': 'Cristi', 'Initials': 'C', 'LastName': 'Ciolino', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY (J.M.S., C.T.D., A.F.Y., D.C., C.C., C.C., M.G.M., L.W.J.).'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Capaci', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY (J.M.S., C.T.D., A.F.Y., D.C., C.C., C.C., M.G.M., L.W.J.).'}, {'ForeName': 'Meghan G', 'Initials': 'MG', 'LastName': 'Michalski', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY (J.M.S., C.T.D., A.F.Y., D.C., C.C., C.C., M.G.M., L.W.J.).'}, {'ForeName': 'Neil D', 'Initials': 'ND', 'LastName': 'Eves', 'Affiliation': 'University of British Columbia, Kelowna, British Columbia, Canada (N.D.E.).'}, {'ForeName': 'Lee W', 'Initials': 'LW', 'LastName': 'Jones', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY (J.M.S., C.T.D., A.F.Y., D.C., C.C., C.C., M.G.M., L.W.J.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.043483']
826,32419688,Dietary intake and processes of behaviour change in a nutrition education intervention for pregnant women in rural Malawi: a cluster-randomised controlled trial.,"OBJECTIVE


To examine if increased intake of locally available nutrient-dense foods among pregnant women improved the quality of their dietary intake and if use of the Theory of Planned Behaviour could explain changes in their dietary behaviour.
DESIGN


We used data from a randomised controlled trial where the intervention group received nutrition education and dietary counselling. We promoted the use of recipes that utilised powders to enhance dietary diversity. We examined how the intervention achieved changes in dietary intakes and used mixed effects logistic regression models with random effects at village level to explore changes over time of the outcomes, adjusted for selected explanatory variables.
SETTING


The study was conducted in twenty villages in rural Malawi.
PARTICIPANTS


Data from 257 pregnant women who were enrolled during late first trimester and followed until birth.
RESULTS


The intervention achieved improvements in the Dietary Diversity Score (DDS) and the Six Food Group Pyramid (SFG) score, especially in intakes of micronutrient-rich foods. A third of the women in the intervention group attained optimal DDS, whereas about 50 % attained optimal SFG. The theorised behaviour mediators (i.e. nutrition attitudes, nutrition behaviour control and subjective norm) that had improved were also significantly associated with high DDS.
CONCLUSIONS


Improved dietary intakes were achieved through promoting the use of locally available nutrient-dense foods. Attainment of high DDS was a consequence of the women's belief in the effectiveness of the proposed nutrition recommendations. We identified critical personal and environmental constraints related to dietary intakes during pregnancy in a low-resource setting.",2020,"The intervention achieved improvements in the Dietary Diversity Score (DDS) and the Six Food Group Pyramid (SFG) score, especially in intakes of micronutrient-rich foods.","['twenty villages in rural Malawi', 'Data from 257 pregnant women who were enrolled during late first trimester and followed until birth', 'pregnant women in rural Malawi', 'pregnant women']","['nutrition education and dietary counselling', 'nutrition education intervention']","['Dietary Diversity Score (DDS) and the Six Food Group Pyramid (SFG) score, especially in intakes of micronutrient-rich foods', 'optimal DDS']","[{'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034229', 'cui_str': 'Pyramidal tract structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0453861', 'cui_str': 'Rich food'}]",257.0,0.0758828,"The intervention achieved improvements in the Dietary Diversity Score (DDS) and the Six Food Group Pyramid (SFG) score, especially in intakes of micronutrient-rich foods.","[{'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Ziyenda Katenga-Kaunda', 'Affiliation': 'Department of Nutrition, University of Oslo, PO Box 1046 Blindern, 0316Oslo, Norway.'}, {'ForeName': 'Per Ole', 'Initials': 'PO', 'LastName': 'Iversen', 'Affiliation': 'Department of Nutrition, University of Oslo, PO Box 1046 Blindern, 0316Oslo, Norway.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Holmboe-Ottesen', 'Affiliation': 'Department of Community Medicine and Global Health, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Fjeld', 'Affiliation': 'Department of Community Medicine and Global Health, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Ibrahimu', 'Initials': 'I', 'LastName': 'Mdala', 'Affiliation': 'Department of Community Medicine and Global Health, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Penjani Rhoda', 'Initials': 'PR', 'LastName': 'Kamudoni', 'Affiliation': 'Department of Nutrition, University of Oslo, PO Box 1046 Blindern, 0316Oslo, Norway.'}]",Public health nutrition,['10.1017/S1368980020000294']
827,32065967,Impact of Chlorhexidine Bathing on Antimicrobial Utilization in Surgical Intensive Care Unit.,"BACKGROUND


This secondary analysis compared antimicrobial utilization among surgical intensive care unit patients randomized to every other day chlorhexidine bathing (chlorhexidine) versus daily soap and water bathing (soap-and-water) using data from the CHlorhexidine Gluconate BATHing trial.
MATERIALS AND METHODS


Antimicrobial utilization was quantified using defined daily dose (DDD)/100 patient-days and agent-days/100 patient-days for systemic antimicrobials. Antivirals (except oseltamivir), antiparasitics, and prophylaxis agents were excluded. The 2018 anatomic therapeutic chemical/DDD index was used to calculate DDD. Agent-days were calculated as the sum of calendar days where antimicrobials were administered. Patient-days were defined as time patients were at risk for health care-acquired infections plus up to 14 d. Primary analyses were conducted using linear regression adjusted for baseline Acute Physiology and Chronic Health Evaluation II scores.
RESULTS


Of 325 CHlorhexidine Gluconate BATHing trial patients, 312 (157 in soap-and-water and 155 in chlorhexidine) were included. The median (interquartile range) of total antimicrobial DDD/100 patient-days was 135.4 (75.2-231.8) for soap-and-water and 129.9 (49.2-215.3) for chlorhexidine. The median (interquartile range) of total antimicrobial agent-days/100 patient-days was 155.6 (83.3-243.2) for soap-and-water and 146.7 (66.7-217.4) for chlorhexidine. After adjusting for Acute Physiology and Chronic Health Evaluation II scores, chlorhexidine bathing was associated with a nonsignificant reduction in total antimicrobial DDD/100 patient-days (-3.9; 95% confidence interval, -33.9 to 26.1; P = 0.80) and total antimicrobial agent-days/100 patient-days (-10.3; 95% confidence interval, -34.7 to 14.1; P = 0.41).
CONCLUSIONS


Compared with daily soap and water bathing, every other day chlorhexidine bathing did not significantly reduce total antimicrobial utilization in surgical intensive care unit patients.",2020,"Compared with daily soap and water bathing, every other day chlorhexidine bathing did not significantly reduce total antimicrobial utilization in surgical intensive care unit patients.","['surgical intensive care unit patients', 'Surgical Intensive Care Unit', 'trial patients, 312 (157 in soap-and-water and 155 in']","['chlorhexidine', 'chlorhexidine bathing (chlorhexidine', 'CHlorhexidine Gluconate', 'Chlorhexidine']","['Antimicrobial utilization', 'total antimicrobial utilization']","[{'cui': 'C1690590', 'cui_str': 'Surgical intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517706', 'cui_str': '312 (qualifier value)'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0043047', 'cui_str': 'Water'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0518460', 'cui_str': 'Bathing (observable entity)'}, {'cui': 'C0055361', 'cui_str': 'chlorhexidine gluconate'}]","[{'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.0951131,"Compared with daily soap and water bathing, every other day chlorhexidine bathing did not significantly reduce total antimicrobial utilization in surgical intensive care unit patients.","[{'ForeName': 'Lan N', 'Initials': 'LN', 'LastName': 'Bui', 'Affiliation': 'Department of Pharmacy Practice, Samford University McWhorter School of Pharmacy, Birmingham, Alabama; Houston Methodist Research Institute, Houston, Texas.'}, {'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Swan', 'Affiliation': 'Houston Methodist Research Institute, Houston, Texas; Department of Pharmacy Services, Houston Methodist Hospital, Houston, Texas; Department of Surgery, Houston Methodist Hospital, Houston, Texas. Electronic address: swan.joshua@gmail.com.'}, {'ForeName': 'Katherine K', 'Initials': 'KK', 'LastName': 'Perez', 'Affiliation': 'Houston Methodist Research Institute, Houston, Texas; Department of Pharmacy Services, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Johnson', 'Affiliation': 'Department of Pharmaceutical Health Outcomes and Policy, University of Houston College of Pharmacy, Houston, Texas.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmaceutical Health Outcomes and Policy, University of Houston College of Pharmacy, Houston, Texas.'}, {'ForeName': 'A Carmine', 'Initials': 'AC', 'LastName': 'Colavecchia', 'Affiliation': 'Department of Pharmacy Services, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Elsie', 'Initials': 'E', 'LastName': 'Rizk', 'Affiliation': 'Houston Methodist Research Institute, Houston, Texas.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Graviss', 'Affiliation': 'Houston Methodist Research Institute, Houston, Texas.'}]",The Journal of surgical research,['10.1016/j.jss.2019.12.049']
828,31551136,The Effect of Hand Massage Before Cataract Surgery on Patient Anxiety and Comfort: A Randomized Controlled Study.,"PURPOSE


This study aimed to determine the effectiveness of hand massage on patient anxiety and comfort before cataract surgery.
DESIGN


A randomized controlled trial.
METHODS


The 140 patients in this study were assigned to the intervention group (n = 70), which received a 10-minute hand massage before cataract surgery, and to the control group (n = 70), which received routine nursing care. The visual analog scale (VAS) and Spielberger State-Trait Anxiety Inventory (STAI) were used to collect data.
FINDINGS


The median STAI state scores of the intervention and control groups were found to be 46.0 (44.7 to 48.0) and 57.0 (55.75 to 59.00), respectively. The VAS comfort score of the intervention group after hand massage (4.0 [1.7-5.0]) was lower than that of the control group immediately before surgery (8.0 [6.0-10.0]) (P < .05). In addition, except oxygen saturation, the remaining vital signs were lower in the intervention group.
CONCLUSIONS


Hand massage reduced the anxiety of patients, positively affected their vital signs, and increased their comfort.",2020,The VAS comfort score of the intervention group after hand massage (4.0 [1.7-5.0]) was lower than that of the control group immediately before surgery (8.0 [6.0-10.0]) (P < .05).,['140 patients'],"['routine nursing care', 'Hand Massage Before Cataract Surgery', 'hand massage', '10-minute hand massage before cataract surgery']","['patient anxiety and comfort', 'VAS comfort score', 'Patient Anxiety and Comfort', 'median STAI state scores', 'visual analog scale (VAS) and Spielberger State-Trait Anxiety Inventory (STAI']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0028682', 'cui_str': 'Nursing Care'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",140.0,0.0424105,The VAS comfort score of the intervention group after hand massage (4.0 [1.7-5.0]) was lower than that of the control group immediately before surgery (8.0 [6.0-10.0]) (P < .05).,"[{'ForeName': 'Ayşe Uyar', 'Initials': 'AU', 'LastName': 'Çavdar', 'Affiliation': 'Department of Surgical Nursing, Institute of Health Science, Manisa Celal Bayar University, Manisa, Turkey.'}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Yılmaz', 'Affiliation': 'Department of Surgical Nursing, Faculty of Health Science, Manisa Celal Bayar University, Manisa, Turkey. Electronic address: emelyilmazcbu@gmail.com.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Baydur', 'Affiliation': 'Department of Social Work, Faculty of Health Science, Manisa Celal Bayar University, Manisa, Turkey.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.06.012']
829,31550352,Significantly Increased Patient Satisfaction Following Liquid Formulation AbobotulinumtoxinA Treatment in Glabellar Lines: FACE-Q Outcomes From a Phase 3 Clinical Trial.,"BACKGROUND


The FACE-Q patient-reported outcome assesses patient experiences/outcomes with aesthetic facial procedure. A recent trial of abobotulinumtoxinA (ASI, liquid formulation) was the first to our knowledge to assess satisfaction with FACE-Q after glabellar line (GL) injection.
OBJECTIVES


The authors sought to evaluate patient satisfaction with ASI for GL treatment employing 3 FACE-Q scales: facial appearance, psychological well-being, and aging appearance.
METHODS


This was a Phase 3, randomized, double-blind, placebo-controlled trial (NCT02353871) of ASI 50 units in adults with moderate-to-severe GL with 6-month follow-up.
RESULTS


Significantly greater least squares mean changes from baseline were associated with ASI treatment (N = 125) vs placebo (N = 59) for satisfaction with facial appearance at all visits until day 148 (5 months; P < 0.0001-0.0037), psychological well-being at all visits (P < 0.0001-0.0279), and aging appearance at all visits except day 148 (P < 0.0001-0.0409). Significant differences (ASI vs placebo) were observed at all visits for individual items: ""how rested your face looks"" (P < 0.0001-0.0415), ""I feel okay about myself"" (P = 0.0011-0.0399), and ""I feel attractive"" (P < 0.0001-0.0102). Maximal least squares mean (standard error) changes in aging appearance score were -1.4 (0.3; ASI) and -0.3 (0.4; placebo). Investigators' live assessment of GL at maximum frown significantly correlated with improvements in FACE-Q facial appearance and psychological scales (all patients: r = -0.41 and r = -0.36 [both P < 0.0001], respectively).
CONCLUSIONS


Significant improvements in patient satisfaction with aging, facial appearance, and, importantly, psychological well-being were demonstrated with ASI employing FACE-Q scales up to 5 to 6 months post-injection. Results support a long duration of efficacy with ASI and use of FACE-Q in future trials and clinical practice.
LEVEL OF EVIDENCE: 1


",2020,"At all visits there were significant differences (ASI vs placebo) for individual items: 'how rested your face looks' (p<0.0001-0.0415), 'I feel okay about myself' (p=0.0011-0.0399), and 'I feel attractive' (p<0.0001-0.0102).","['ASI 50 units in adults with moderate-to-severe GL, with 6-month follow-up']","['placebo', 'abobotulinumtoxinA (ASI, liquid-formulation']","['satisfaction with facial appearance', 'Patient Satisfaction', 'Maximal LS mean (standard error) changes in aging appearance score', 'patient satisfaction with aging and facial appearance', 'rested your face looks', 'FACE-Q facial appearance and psychological scales']","[{'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2719424', 'cui_str': 'abobotulinumtoxinA'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0282631', 'cui_str': 'Facies'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0222045'}]",,0.167176,"At all visits there were significant differences (ASI vs placebo) for individual items: 'how rested your face looks' (p<0.0001-0.0415), 'I feel okay about myself' (p=0.0011-0.0399), and 'I feel attractive' (p<0.0001-0.0102).","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ascher', 'Affiliation': 'Iena Plastic Surgery Clinic, Paris, France.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Rzany', 'Affiliation': 'Rzany and Hund, Berlin, Germany.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Kestemont', 'Affiliation': 'Mediti Centre, Antibes-Juan Les Pins, France.'}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Hilton', 'Affiliation': 'Dr. Hilton & Partner, Düsseldorf, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Heckmann', 'Affiliation': 'Starnberg Skin Centre, Starnberg, Germany.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Bodokh', 'Affiliation': 'Dermatology Department, Cannes Hospital, Cannes, France.'}, {'ForeName': 'Ernst Magnus', 'Initials': 'EM', 'LastName': 'Noah', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Red Cross Hospital, Kassel, Germany.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Boineau', 'Affiliation': 'Clinique Chirurgicale Bel-Air, Bordeaux, France.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Kerscher', 'Affiliation': 'Division of Cosmetic Science, Department of Chemistry, University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Volteau', 'Affiliation': 'Neurology Development, Ipsen Innovation, Les Ulis, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Le Berre', 'Affiliation': 'Neurology Development, Ipsen Innovation, Les Ulis, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Picaut', 'Affiliation': 'Neurology Development, Ipsen Innovation, Les Ulis, Paris, France.'}]",Aesthetic surgery journal,['10.1093/asj/sjz248']
830,31552500,A comparison between whole grain and pearled oats: acute postprandial glycaemic responses and in vitro carbohydrate digestion in healthy subjects.,"PURPOSE


To compare the glycaemic response of whole grain oat kernels and pearled oats cooked under normal pressure or higher pressure and examine whether replacing half of the rice in a given meal with either of the two oat grains could make a difference in acute glycaemic responses.
METHODS


In a randomised crossover trial, ten healthy subjects consumed two groups of test meals: (1) oat grain-only, including whole grain oats cooked under normal pressure (WONP) and higher pressure (WOHP) as well as their pearled oat counterparts, PONP and POHP; and (2) mixed meals of aforementioned oat grains and cooked rice (OG + R), including WONP + R, WOHP + R, PONP + R and POHP + R. A postprandial blood glucose test, texture profile analysis and in vitro carbohydrate digestion assay were carried out for each test meal.
RESULTS


Compared with the rice reference, oat grain-only meals induced lower glucose levels at all time points, lower peak values and smaller glucose excursions at 120 min (P < 0.05), but OG + Rs did not have the abovementioned effects. The oat grain-only meals had glycaemic indexes (GIs) ranging from 51 to 58, while those of OG + Rs ranged from 59 to 70. WONP + R had a 21% lower iAUC 0-60  and a 40% lower iAUC 60-120  value than those of rice (P < 0.05). Oat-rice mixed meals had lower iAUC 0-60  values compared with that of the rice control (P < 0.05), except for POHP + R. Excellent consistency between the hydrolysis index and the GI was observed (r = 0.969, P < 0.001) in oat grain-only meals.
CONCLUSIONS


All oat grain-only meals could be included in the glycaemic management diet, regardless of the oat grain type or cooking treatment. In oat-rice mixed meals, whole grain oats and normal pressure cooking ensured a favourable glycaemic effect.",2020,"Compared with the rice reference, oat grain-only meals induced lower glucose levels at all time points, lower peak values and smaller glucose excursions at 120 min (P < 0.05), but OG + Rs did not have the abovementioned effects.","['ten healthy subjects consumed two groups of test meals: (1', 'healthy subjects']","['whole grain and pearled oats: acute postprandial glycaemic responses and in vitro carbohydrate digestion', 'WONP', 'oat-rice mixed meals, whole grain oats and normal pressure cooking', 'oat grain-only, including whole grain oats cooked under normal pressure (WONP) and higher pressure (WOHP) as well as their pearled oat counterparts, PONP and POHP; and (2) mixed meals of aforementioned oat grains and cooked rice (OG\u2009+\u2009R), including WONP\u2009+\u2009R, WOHP\u2009+\u2009R, PONP\u2009+\u2009R and POHP\u2009+\u2009R. A postprandial blood glucose test, texture profile analysis and in vitro carbohydrate digestion assay were carried out for each test meal', 'whole grain oat kernels and pearled oats cooked under normal pressure']","['acute glycaemic responses', 'peak values and smaller glucose excursions', 'glycaemic response', 'glucose levels']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0012238', 'cui_str': 'Digestion'}, {'cui': 'C0028753', 'cui_str': 'Oats (substance)'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0086369', 'cui_str': 'Grain (substance)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1306756', 'cui_str': 'Cook (occupation)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449582', 'cui_str': 'With texture (attribute)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0439787', 'cui_str': 'Out (qualifier value)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}]",10.0,0.0262235,"Compared with the rice reference, oat grain-only meals induced lower glucose levels at all time points, lower peak values and smaller glucose excursions at 120 min (P < 0.05), but OG + Rs did not have the abovementioned effects.","[{'ForeName': 'Ruixin', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': 'Beijing Advanced Innovation Centre for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, 100083, China.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': 'Beijing Advanced Innovation Centre for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, 100083, China. daisyfan@cau.edu.cn.'}, {'ForeName': 'Guojing', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Beijing Advanced Innovation Centre for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, 100083, China.'}, {'ForeName': 'Yixue', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Beijing Advanced Innovation Centre for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, 100083, China.'}, {'ForeName': 'Wenqi', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Beijing Advanced Innovation Centre for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, 100083, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Ye', 'Affiliation': 'Beijing Advanced Innovation Centre for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, 100083, China.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Beijing Advanced Innovation Centre for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, 100083, China.'}]",European journal of nutrition,['10.1007/s00394-019-02083-5']
831,31017843,Time-trend impact on treatment estimation in two-arm clinical trials with a binary outcome and Bayesian response adaptive randomization.,"Clinical trial design and analysis often assume study population homogeneity, although patient baseline profile and standard of care may evolve over time, especially in trials with long recruitment periods. The time-trend phenomenon can affect the treatment estimation and the operating characteristics of trials with Bayesian response adaptive randomization (BRAR). The mechanism of time-trend impact on BRAR is increasingly being studied but some aspects remain unclear. The goal of this research is to quantify the bias in treatment effect estimation due to the use of BRAR in the presence of time-trend. In addition, simulations are conducted to compare the performance of three commonly used BRAR algorithms under different time-trend patterns with and without early stopping rules. The results demonstrate that using these BRAR methods in a two-arm trial with time-trend may cause type I error inflation and treatment effect estimation bias. The magnitude and direction of the bias are affected by the parameters of the BRAR algorithm and the time-trend pattern.",2020,The magnitude and direction of the bias are affected by the parameters of the BRAR algorithm and the time-trend pattern.,[],[],[],[],[],[],,0.164152,The magnitude and direction of the bias are affected by the parameters of the BRAR algorithm and the time-trend pattern.,"[{'ForeName': 'Yunyun', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Epidemiology and Biostatistics, George Washington University, Rockville, Maryland, USA.'}, {'ForeName': 'Wenle', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Durkalski-Mauldin', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}]",Journal of biopharmaceutical statistics,['10.1080/10543406.2019.1607368']
832,32418680,The effect of nutritional education program on quality of life and serum electrolytes levels in hemodialysis patients: A single-blind randomized controlled trial.,"OBJECTIVE


To determine the effect of nutrition education program on hemodialysis patients' quality of life (QoL) and serum electrolytes levels.
METHODS


This study was a randomized controlled trial in which 94 eligible hemodialysis patients were randomly assigned to intervention (n = 48) and control (n = 46) groups. In the intervention group, the patients were trained in healthy nutrition for four weeks. After two months, samples of both groups completed the Kidney Disease Quality of Life Instrument (KDQOL) and Na, K, P, Ca and Mg levels were also measured and compared.
RESULTS


There were no significant differences in QoL scores and electrolytes between the two groups before intervention (p > 0.05). After intervention the QoL scores in the intervention group were significantly higher than in the control group (p < 0.05). However, after intervention the levels of Na, K, P and Mg in the intervention group were significantly lower than in the control group (p < 0.05). Calcium level was not significantly different between the two groups after intervention (p = 0.16).
CONCLUSION


The results showed that e-learning is effective in improving the QoL and serum electrolytes of hemodialysis patients.
PRACTICE IMPLICATIONS


This paper could serve as support for clinical healthcare professionals to improve patient knowledge and QoL through virtual education methods.",2020,After intervention the QoL scores in the intervention group were significantly higher than in the control group (p < 0.05).,"['94 eligible hemodialysis patients', 'hemodialysis patients']","['nutritional education program', 'nutrition education program']","['QoL scores and electrolytes', 'quality of life and serum electrolytes levels', 'levels of Na, K, P and Mg', ""hemodialysis patients' quality of life (QoL) and serum electrolytes levels"", 'Calcium level', 'QoL and serum electrolytes', 'Kidney Disease Quality of Life Instrument (KDQOL) and Na, K, P, Ca and Mg levels', 'QoL scores']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0204934', 'cui_str': 'Nutrition education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C1287347', 'cui_str': 'Serum electrolyte levels - finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0201925', 'cui_str': 'Calcium measurement'}, {'cui': 'C0587355', 'cui_str': 'Electrolytes measurement, serum'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}]",94.0,0.0310619,After intervention the QoL scores in the intervention group were significantly higher than in the control group (p < 0.05).,"[{'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Naseri-Salahshour', 'Affiliation': 'School of Nursing and Midwifery, Saveh University of Medical Sciences, Saveh, Iran. Electronic address: vahidnaseri1994@yahoo.com.'}, {'ForeName': 'Mahbobeh', 'Initials': 'M', 'LastName': 'Sajadi', 'Affiliation': 'Clinical Research Development Center of Amiralmomenin Hospital, Arak University of Medical Sciences, Basij Sq., Sardasht Region, 6941738481 Arak, Iran. Electronic address: sajadimahbobeh@yahoo.com.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Nikbakht-Nasrabadi', 'Affiliation': 'School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: nikbakht@tums.ac.ir.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Davodabady', 'Affiliation': 'Clinical Research Development Center of Amiralmomenin Hospital, Arak University of Medical Sciences, Arak, Basij Sq., Sardasht Region, 6941738481 Iran. Electronic address: fahimedavodabady@gmail.com.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fournier', 'Affiliation': 'College of Doctoral Studies, Grand Canyon University, Phoenix, AZ, USA. Electronic address: afournier2@my.gcu.edu.'}]",Patient education and counseling,['10.1016/j.pec.2020.03.021']
833,31555976,EPA and DHA as markers of nutraceutical treatment response in major depressive disorder.,"PURPOSE


Depression clinical trials are increasingly studying biomarkers to predict and monitor response to treatment. Assessment of biomarkers may reveal subsets of patients who are responsive to nutraceutical treatment, which may facilitate a personalized approach to treating depression.
METHODS


This is a post hoc analysis of an 8-week, double-blind, randomized, controlled trial (n = 158) investigating a combination nutraceutical comprising Omega-3 (EPA 1 g/DHA 656 mg), SAMe, zinc, 5-HTP, folinic acid, and co-factors versus placebo for the treatment of Major Depressive Disorder. The study explored levels of polyunsaturated fatty acids, folate, vitamin B12, zinc, homocysteine, and BDNF as possible predictors and correlates of response to nutraceutical supplementation.
RESULTS


Concentrations of EPA and DHA in red cell membranes increased in response to treatment and were significantly correlated with a decrease in depressive symptoms during active treatment (p = 0.003 and p = 0.029; respectively). Higher baseline levels of omega-6 fatty acid also correlated with depression reduction in the active treatment group ( p = 0.011). No other biomarkers were associated with a lessening of depressive symptoms.
CONCLUSION


Changes in fatty acid levels resulting from a nutraceutical combination containing EPA and DHA provide a response biomarker in treating depression.",2020,Higher baseline levels of omega-6 fatty acid also correlated with depression reduction in the active treatment group ( p = 0.011).,"['major depressive disorder', 'Major Depressive Disorder']","['combination nutraceutical comprising Omega-3 (EPA 1\xa0g/DHA 656\xa0mg), SAMe, zinc, 5-HTP, folinic acid, and co-factors versus placebo', 'EPA and DHA']","['polyunsaturated fatty acids, folate, vitamin B12, zinc, homocysteine, and BDNF', 'depression reduction', 'depressive symptoms', 'Concentrations of EPA and DHA in red cell membranes', 'omega-6 fatty acid']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C1518478', 'cui_str': 'Nutraceuticals'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0635011', 'cui_str': 'Epa-1'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0000578', 'cui_str': '5-Hydroxytryptophan'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0019878', 'cui_str': '2-amino-4-mercaptobutyric acid'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0007603', 'cui_str': 'Cytoplasmic Membrane'}, {'cui': 'C0133860', 'cui_str': 'Fatty Acids, Omega-6'}]",,0.311991,Higher baseline levels of omega-6 fatty acid also correlated with depression reduction in the active treatment group ( p = 0.011).,"[{'ForeName': 'Kiki P', 'Initials': 'KP', 'LastName': 'van der Burg', 'Affiliation': 'MaSc Medicine at University Medical Center Utrecht (UMCU), Utrecht, The Netherlands.'}, {'ForeName': 'Lachlan', 'Initials': 'L', 'LastName': 'Cribb', 'Affiliation': 'Professorial Unit, The Melbourne Clinic, Department of Psychiatry, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Firth', 'Affiliation': 'NICM Health Research Institute, Western Sydney University, Westmead, Australia.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Karmacoska', 'Affiliation': 'NICM Health Research Institute, Western Sydney University, Westmead, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mischoulon', 'Affiliation': 'Depression Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Byrne', 'Affiliation': ""Faculty of Medicine, Discipline of Psychiatry, Centre for Clinical Research, Royal Brisbane and Women's Hospital, The University of Queensland, Herston, Australia.""}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Bousman', 'Affiliation': 'Departments of Medical Genetics, Psychiatry, and Physiology and Pharmacology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Con', 'Initials': 'C', 'LastName': 'Stough', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn, Australia.'}, {'ForeName': 'Jenifer', 'Initials': 'J', 'LastName': 'Murphy', 'Affiliation': 'Professorial Unit, The Melbourne Clinic, Department of Psychiatry, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Oliver', 'Affiliation': 'Professorial Unit, The Melbourne Clinic, Department of Psychiatry, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'Department of Psychiatry, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Chee H', 'Initials': 'CH', 'LastName': 'Ng', 'Affiliation': 'Professorial Unit, The Melbourne Clinic, Department of Psychiatry, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Sarris', 'Affiliation': 'Professorial Unit, The Melbourne Clinic, Department of Psychiatry, The University of Melbourne, Melbourne, Australia. j.sarris@westernsydney.edu.au.'}]",European journal of nutrition,['10.1007/s00394-019-02090-6']
834,31555824,"Safety, Tolerability, and Immunogenicity of Plasmodium falciparum Sporozoite Vaccine Administered by Direct Venous Inoculation to Infants and Young Children: Findings From an Age De-escalation, Dose-Escalation, Double-blind, Randomized Controlled Study in Western Kenya.","BACKGROUND


The whole Plasmodium falciparum sporozoite (PfSPZ) vaccine is being evaluated for malaria prevention. The vaccine is administered intravenously for maximal efficacy. Direct venous inoculation (DVI) with PfSPZ vaccine has been safe, tolerable, and feasible in adults, but safety data for children and infants are limited.
METHODS


We conducted an age de-escalation, dose-escalation randomized controlled trial in Siaya County, western Kenya. Children and infants (aged 5-9 years, 13-59 months, and 5-12 months) were enrolled into 13 age-dose cohorts of 12 participants and randomized 2:1 to vaccine or normal saline placebo in escalating doses: 1.35 × 105, 2.7 × 105, 4.5 × 105, 9.0 × 105, and 1.8 × 106 PfSPZ, with the 2 highest doses given twice, 8 weeks apart. Solicited adverse events (AEs) were monitored for 8 days after vaccination, unsolicited AEs for 29 days, and serious AEs throughout the study. Blood taken prevaccination and 1 week postvaccination was tested for immunoglobulin G antibodies to P. falciparum circumsporozoite protein (PfCSP) using enzyme-linked immunosorbent assay.
RESULTS


Rates of AEs were similar in vaccinees and controls for solicited (35.7% vs 41.5%) and unsolicited (83.9% vs 92.5%) AEs, respectively. No related grade 3 AEs, serious AEs, or grade 3 laboratory abnormalities occurred. Most (79.0%) vaccinations were administered by a single DVI. Among those in the 9.0 × 105 and 1.8 × 106 PfSPZ groups, 36 of 45 (80.0%) vaccinees and 4 of 21 (19.0%) placebo controls developed antibodies to PfCSP (P < .001).
CONCLUSIONS


PfSPZ vaccine in doses as high as 1.8 × 106 can be administered to infants and children by DVI, and was safe, well tolerated, and immunogenic.
CLINICAL TRIALS REGISTRATION


NCT02687373.",2020,"RESULTS


Rates of AEs were similar in vaccinees and controls for solicited (35.7% vs. 41.5%) and unsolicited (83.9% vs. 92.5%) AEs, respectively.","['infants and young children', 'Children and infants (5-9 years, 13-59 months, and 5-12 months) were enrolled into 13 age-dose cohorts of 12 participants', 'Siaya County, western Kenya']","['placebo', 'Direct venous inoculation (DVI) with PfSPZ Vaccine', 'PfSPZ Vaccine', 'vaccine or normal saline placebo in escalating doses: 1.35x105, 2.7x105, 4.5x105, 9.0x105, and 1.8x106Plasmodium falciparum sporozoites (PfSPZ']","['grade 3 AEs, SAEs, or grade 3 laboratory abnormalities', 'Safety, tolerability, and immunogenicity', 'Solicited adverse events (AEs']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0562648', 'cui_str': 'Sporozoites'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0639010', 'cui_str': '3-AES'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.234921,"RESULTS


Rates of AEs were similar in vaccinees and controls for solicited (35.7% vs. 41.5%) and unsolicited (83.9% vs. 92.5%) AEs, respectively.","[{'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Steinhardt', 'Affiliation': 'Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Richie', 'Affiliation': 'Sanaria Inc, Rockville, Maryland, USA.'}, {'ForeName': 'Reuben', 'Initials': 'R', 'LastName': 'Yego', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.'}, {'ForeName': 'Dorcas', 'Initials': 'D', 'LastName': 'Akach', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Hamel', 'Affiliation': 'Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Gutman', 'Affiliation': 'Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Wiegand', 'Affiliation': 'Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Nzuu', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Dungani', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Kc', 'Affiliation': 'Sanaria Inc, Rockville, Maryland, USA.'}, {'ForeName': 'Tooba', 'Initials': 'T', 'LastName': 'Murshedkar', 'Affiliation': 'Sanaria Inc, Rockville, Maryland, USA.'}, {'ForeName': 'L W Preston', 'Initials': 'LWP', 'LastName': 'Church', 'Affiliation': 'Sanaria Inc, Rockville, Maryland, USA.'}, {'ForeName': 'B Kim Lee', 'Initials': 'BKL', 'LastName': 'Sim', 'Affiliation': 'Sanaria Inc, Rockville, Maryland, USA.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Billingsley', 'Affiliation': 'Sanaria Inc, Rockville, Maryland, USA.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'James', 'Affiliation': 'Sanaria Inc, Rockville, Maryland, USA.'}, {'ForeName': 'Yonas', 'Initials': 'Y', 'LastName': 'Abebe', 'Affiliation': 'Sanaria Inc, Rockville, Maryland, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kariuki', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Samuels', 'Affiliation': 'Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Kephas', 'Initials': 'K', 'LastName': 'Otieno', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Sang', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.'}, {'ForeName': 'S Patrick', 'Initials': 'SP', 'LastName': 'Kachur', 'Affiliation': 'Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Styers', 'Affiliation': 'The Emmes Corporation, Rockville, Maryland, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Schlessman', 'Affiliation': 'The Emmes Corporation, Rockville, Maryland, USA.'}, {'ForeName': 'Ginnie', 'Initials': 'G', 'LastName': 'Abarbanell', 'Affiliation': ""Washington University School of Medicine and St Louis Children's Hospital, St Louis, Missouri, USA.""}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Hoffman', 'Affiliation': 'Sanaria Inc, Rockville, Maryland, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Seder', 'Affiliation': 'National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Oneko', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz925']
835,32091610,"Use of a Digital Cognitive Aid in the Early Management of Simulated War Wounds in a Combat Environment, a Randomized Trial.","INTRODUCTION


The French army has implemented an algorithm based on the acronym ""MARCHE RYAN,"" each letter standing for a key action to complete in order to help first care providers during emergency casualty care. On the battlefield, the risk of error is increased, and the use of cognitive aids (CAs) might be helpful to avoid distraction. We investigated the effect of using a digital CA (MAX, for Medical Assistance eXpert) by combat casualty care providers on their technical and nontechnical performances during the early management of simulated war wounds, compared to their memory and training alone.
MATERIALS AND METHODS


We conducted a randomized, controlled, unblinded study between July 2016 and February 2017. This study was approved by the Ethics Committee of the Ethical Board of Desgenettes Army Training Hospital (14.06.2017 n°385) and was registered on clinicaltrials.gov (NCT03483727). It took place during medicalization training in hostile environment (""MEDICHOS"") in Chamonix Mont-Blanc and in the first aid training center in La Valbonne military base (France). Each participant had to deal with two different scenarios, one with MAX (MAX+) and the other without (MAX-). Scenarios were held using either high-fidelity patient simulators or actors as wounded patients. The primary outcome was participants' technical performance rated as their adherence to the MARCHE RYAN procedure (maximum 100%). The secondary outcome was the nontechnical performance according to the Ottawa crisis resource management Global Rating Scale (maximum 42).
RESULTS


Technical performance was significantly higher in the MAX+ scenarios (70.60 IQR [63.70-73.56] than in the MAX- scenarios (56.25 IQR [52.88-62.09], p = 0.002). The Ottawa scores were significantly higher in the MAX+ scenarios (31.50 IQR [29.50-33.75]) than in the MAX- scenarios (29.50 IQR [24.50-32.00], p = 0.031).
CONCLUSIONS


The use of a digital CA by combat casualty care providers improved technical and nontechnical performances during field training of simulated crises. Following recommendations on the design and use of CA, regular team training would improve fluidity in the use and acceptance of an aid, by a highly drilled professional corporation with a strong culture of leadership. Digital CA should be tested at a larger scale in order to validate their contribution to real combat casualty care.",2020,The use of a digital CA by combat casualty care providers improved technical and nontechnical performances during field training of simulated crises.,['July 2016 and February 2017'],"['CA, regular team training', 'MAX (MAX+) and the other without (MAX', 'cognitive aids (CAs', 'digital CA (MAX, for Medical Assistance eXpert', 'Digital Cognitive Aid']","['nontechnical performance according to the Ottawa crisis resource management Global Rating Scale (maximum 42', 'Technical performance', 'technical performance rated as their adherence to the MARCHE RYAN procedure']",[],"[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0025070', 'cui_str': 'Medical Assistance'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}]","[{'cui': 'C0231224', 'cui_str': 'Crisis (finding)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]",,0.0500687,The use of a digital CA by combat casualty care providers improved technical and nontechnical performances during field training of simulated crises.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Truchot', 'Affiliation': ""Centre Lyonnais d'Enseignement par la Simulation en Santé, SAMSEI, Université Claude Bernard Lyon 1, 8 avenue Rockefeller- 69372 LYON CEDEX 08, Lyon, France.""}, {'ForeName': 'Baptiste', 'Initials': 'B', 'LastName': 'Balança', 'Affiliation': ""Centre Lyonnais d'Enseignement par la Simulation en Santé, SAMSEI, Université Claude Bernard Lyon 1, 8 avenue Rockefeller- 69372 LYON CEDEX 08, Lyon, France.""}, {'ForeName': 'Pierre François', 'Initials': 'PF', 'LastName': 'Wey', 'Affiliation': ""Centre Lyonnais d'Enseignement par la Simulation en Santé, SAMSEI, Université Claude Bernard Lyon 1, 8 avenue Rockefeller- 69372 LYON CEDEX 08, Lyon, France.""}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Tazarourte', 'Affiliation': 'Health Services and Performance Research EA74, Université Claude Bernard Lyon1, 43 Boulevard du 11 Novembre 1918, 69100 Villeurbanne, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lecomte', 'Affiliation': 'Emergency Department, Hôpital Cochin, 27 Rue du Faubourg Saint-Jacques, 75014 Paris, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Le Goff', 'Affiliation': 'Direction de la Médecine des Forces, Bureau Soutien des Activités Opérationnelles, BA 705 - RD 910, 37076 Tour Cedex 02, France.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Leigh-Smith', 'Affiliation': 'Royal Infirmary of Edinburgh, Emergency Department, 51 Little France Cres, Edinburgh EH16 4SA, Scotland.'}, {'ForeName': 'Jean Jacques', 'Initials': 'JJ', 'LastName': 'Lehot', 'Affiliation': ""Centre Lyonnais d'Enseignement par la Simulation en Santé, SAMSEI, Université Claude Bernard Lyon 1, 8 avenue Rockefeller- 69372 LYON CEDEX 08, Lyon, France.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rimmele', 'Affiliation': ""Centre Lyonnais d'Enseignement par la Simulation en Santé, SAMSEI, Université Claude Bernard Lyon 1, 8 avenue Rockefeller- 69372 LYON CEDEX 08, Lyon, France.""}, {'ForeName': 'Jean Christophe', 'Initials': 'JC', 'LastName': 'Cejka', 'Affiliation': ""Centre Lyonnais d'Enseignement par la Simulation en Santé, SAMSEI, Université Claude Bernard Lyon 1, 8 avenue Rockefeller- 69372 LYON CEDEX 08, Lyon, France.""}]",Military medicine,['10.1093/milmed/usz482']
836,31555836,[Treatment adherence and effectiveness of anti-Vascular Endothelial Growth Faktor(VEGF) treatment of diabetic macular edema in the clinical routine : Comparison between cooperative and unicentric organization of treatment].,"BACKGROUND


Intravitreal injection of anti-vascular endothelial growth factor (VEGF) is an established method for treatment of diabetic macular edema (DME); however, to ensure the best possible functional results continuous treatment of patients over a long period with regular control visits are necessary. The adherence of patients to the treatment is of great importance for success.
METHODS


In order to make implementation of treatment easier for patients, an internet-based referral platform was established to enable the follow-up examination to be performed by an ophthalmologist using spectal domain optical coherence tomography (SD-OCT) close to the patients place of residence. Based on 50 patients the effectiveness of this cooperative treatment (IT-Cooperation) was compared to 50 patients who were controlled in the treatment center for DME patients over a period of 2 years.
RESULTS


Patients in the IT-Cooperation group received an average of 6.3 injections in the first year of follow-up compared to the lower number of 5.2 injections for patients attending the treatment center. During the second year the average number of injections decreased to 2.7 (IT-Cooperation) and 2.4 (treatment center). Patients of the IT-Cooperation showed an average of 12.0 control visits in contrast to the average number of 9.6 visits (p < 0.01) for patients attending the treatment center in the first year of observation. This difference between the two groups was significant and was confirmed in the second year of follow-up with 8.3 visits in the IT-Cooperation group compared to 4.4 visits in the treatment center group (p < 0.01).
CONCLUSION


The greater number of follow-up examinations close to the patient's place of residence for the IT-Cooperation group significantly improved the quality of treatment adherence in DME patients; however, intensive exchange of information between the ophthalmologist performing the control examinations and the treatment center where the injections were carried out is mandatory.",2020,During the second year the average number of injections decreased to 2.7 (IT-Cooperation) and 2.4 (treatment center).,"['50 patients who were controlled in the treatment center for DME patients over a period of 2\xa0years', 'diabetic macular edema', 'diabetic macular edema (DME']","['anti-vascular endothelial growth factor (VEGF', 'anti-Vascular Endothelial Growth Faktor(VEGF']",['quality of treatment adherence'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0641456', 'cui_str': 'DMES'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}]",,0.0180065,During the second year the average number of injections decreased to 2.7 (IT-Cooperation) and 2.4 (treatment center).,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Faatz', 'Affiliation': 'Augenzentrum am St.\xa0Franziskus-Hospital Münster, Hohenzollernring\xa074, 48145, Münster, Deutschland. henrik.faatz@augen-franziskus.de.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Rothaus', 'Affiliation': 'Augenzentrum am St.\xa0Franziskus-Hospital Münster, Hohenzollernring\xa074, 48145, Münster, Deutschland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Westhues', 'Affiliation': 'Augenzentrum am St.\xa0Franziskus-Hospital Münster, Hohenzollernring\xa074, 48145, Münster, Deutschland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Heimes-Bussmann', 'Affiliation': 'Augenzentrum am St.\xa0Franziskus-Hospital Münster, Hohenzollernring\xa074, 48145, Münster, Deutschland.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Farecki', 'Affiliation': 'Augenzentrum am St.\xa0Franziskus-Hospital Münster, Hohenzollernring\xa074, 48145, Münster, Deutschland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ziegler', 'Affiliation': 'Augenzentrum am St.\xa0Franziskus-Hospital Münster, Hohenzollernring\xa074, 48145, Münster, Deutschland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gutfleisch', 'Affiliation': 'Augenzentrum am St.\xa0Franziskus-Hospital Münster, Hohenzollernring\xa074, 48145, Münster, Deutschland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Spital', 'Affiliation': 'Augenzentrum am St.\xa0Franziskus-Hospital Münster, Hohenzollernring\xa074, 48145, Münster, Deutschland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lommatzsch', 'Affiliation': 'Augenzentrum am St.\xa0Franziskus-Hospital Münster, Hohenzollernring\xa074, 48145, Münster, Deutschland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Pauleikhoff', 'Affiliation': 'Augenzentrum am St.\xa0Franziskus-Hospital Münster, Hohenzollernring\xa074, 48145, Münster, Deutschland.'}]",Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft,['10.1007/s00347-019-00977-7']
837,32418770,Comment on: Severe obesity and vitamin D deficiency treatment options before the bariatric surgery: a randomized clinical trial.,,2020,,[],[],[],[],[],[],,0.0865464,,"[{'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Furtado', 'Affiliation': 'Department of Bariatric Surgery, University of Maryland Medical Center, Baltimore, Maryland.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.04.004']
838,26199949,First-in-Human Evaluation of the Safety and Immunogenicity of a Recombinant Vesicular Stomatitis Virus Human Immunodeficiency Virus-1 gag Vaccine (HVTN 090).,"Background.  We report the first-in-human safety and immunogenicity evaluation of a highly attenuated, replication-competent recombinant vesicular stomatitis virus (rVSV) human immunodeficiency virus (HIV)-1 vaccine. Methods.  Sixty healthy, HIV-1-uninfected adults were enrolled in a randomized, double-blinded, placebo-controlled dose-escalation study. Groups of 12 participants received rVSV HIV-1 gag vaccine at 5 dose levels (4.6 × 10(3) to 3.4 × 10(7) particle forming units) (N = 10/group) or placebo (N = 2/group), delivered intramuscularly as bilateral injections at 0 and 2 months. Safety monitoring included VSV cultures from blood, urine, saliva, and swabs of oral lesions. Vesicular stomatitis virus-neutralizing antibodies, T-cell immunogenicity, and HIV-1 specific binding antibodies were assessed. Results.  Local and systemic reactogenicity symptoms were mild to moderate and increased with dose. No severe reactogenicity or product-related serious adverse events were reported, and all rVSV cultures were negative. All vaccine recipients became seropositive for VSV after 2 vaccinations. gag-specific T-cell responses were detected in 63% of participants by interferon-γ enzyme-linked immunospot at the highest dose post boost. Conclusions.  An attenuated replication-competent rVSV gag vaccine has an acceptable safety profile in healthy adults. This rVSV vector is a promising new vaccine platform for the development of vaccines to combat HIV-1 and other serious human diseases.",2015,gag-specific T-cell responses were detected in 63% of participants by interferon-γ enzyme-linked immunospot at the highest dose post boost.,"['Sixty healthy, HIV-1-uninfected adults', 'healthy adults']","['replication-competent recombinant vesicular stomatitis virus (rVSV) human immunodeficiency virus (HIV)-1 vaccine', 'rVSV HIV-1 gag vaccine', 'placebo', 'Recombinant Vesicular Stomatitis Virus Human Immunodeficiency Virus-1 gag Vaccine (HVTN 090']","['gag-specific T-cell responses', 'Local and systemic reactogenicity symptoms', 'VSV cultures from blood, urine, saliva, and swabs of oral lesions', 'severe reactogenicity or product-related serious adverse events']","[{'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C1623048', 'cui_str': 'Vesicular stomatitis virus (organism)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0328767', 'cui_str': 'Mycteroperca microlepis (organism)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0328767', 'cui_str': 'Mycteroperca microlepis (organism)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0005768'}, {'cui': 'C0042037'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C1261188', 'cui_str': 'Swab (physical object)'}, {'cui': 'C0149744', 'cui_str': 'Oral lesion (finding)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.274579,gag-specific T-cell responses were detected in 63% of participants by interferon-γ enzyme-linked immunospot at the highest dose post boost.,"[{'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Fuchs', 'Affiliation': 'San Francisco Department of Public Health, California ; University of California , San Francisco.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Frank', 'Affiliation': 'University of Pennsylvania , Philadelphia.'}, {'ForeName': 'Marnie L', 'Initials': 'ML', 'LastName': 'Elizaga', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Allen', 'Affiliation': 'Division of AIDS, National Institutes of Allergy and Infectious Diseases , Bethesda, Maryland.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Frahm', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Kochar', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention , Fred Hutchinson Cancer Research Center , Seattle, Washington.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention , Fred Hutchinson Cancer Research Center , Seattle, Washington.'}, {'ForeName': 'Srilatha', 'Initials': 'S', 'LastName': 'Edupuganti', 'Affiliation': 'Emory University , Atlanta, Georgia.'}, {'ForeName': 'Spyros A', 'Initials': 'SA', 'LastName': 'Kalams', 'Affiliation': 'Vanderbilt University , Nashville, Tennessee.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Duke Human Vaccine Institute, Duke University Medical Center , Durham, North Carolina.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Sheets', 'Affiliation': 'Division of AIDS, National Institutes of Allergy and Infectious Diseases , Bethesda, Maryland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pensiero', 'Affiliation': 'Division of AIDS, National Institutes of Allergy and Infectious Diseases , Bethesda, Maryland.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Tremblay', 'Affiliation': 'Profectus Biosciences, Inc. , Tarrytown, New York.'}, {'ForeName': 'Terry J', 'Initials': 'TJ', 'LastName': 'Higgins', 'Affiliation': 'Profectus Biosciences, Inc. , Tarrytown, New York.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Latham', 'Affiliation': 'Profectus Biosciences, Inc. , Tarrytown, New York.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Egan', 'Affiliation': 'Profectus Biosciences, Inc. , Tarrytown, New York.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Clarke', 'Affiliation': 'Profectus Biosciences, Inc. , Tarrytown, New York.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Eldridge', 'Affiliation': 'Profectus Biosciences, Inc. , Tarrytown, New York.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mulligan', 'Affiliation': ''}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Rouphael', 'Affiliation': ''}, {'ForeName': 'Scharla', 'Initials': 'S', 'LastName': 'Estep', 'Affiliation': ''}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Rybczyk', 'Affiliation': ''}, {'ForeName': 'Deb', 'Initials': 'D', 'LastName': 'Dunbar', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Buchbinder', 'Affiliation': ''}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Wagner', 'Affiliation': ''}, {'ForeName': 'Reese', 'Initials': 'R', 'LastName': 'Isbell', 'Affiliation': ''}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Chinnell', 'Affiliation': ''}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Bae', 'Affiliation': ''}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Escamilla', 'Affiliation': ''}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Tseng', 'Affiliation': ''}, {'ForeName': 'Ramey', 'Initials': 'R', 'LastName': 'Fair', 'Affiliation': ''}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Ramirez', 'Affiliation': ''}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Broder', 'Affiliation': ''}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Briesemeister', 'Affiliation': ''}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Ferrara', 'Affiliation': ''}]",Open forum infectious diseases,['10.1093/ofid/ofv082']
839,31549147,Treatment Outcome of a Shorter Regimen Containing Clofazimine for Multidrug-resistant Tuberculosis: A Randomized Control Trial in China.,"BACKGROUND


The emergence of multidrug-resistant tuberculosis (MDR-TB) poses a serious obstacle to global TB control programs.
METHODS


We carried out a prospective, randomized, multicenter study in China that was focused on the potential of a shorter regimen containing clofazimine (CFZ) for the treatment of MDR-TB. There were 135 MDR-TB cases that met eligibility requirements and were randomly stratified into either the control group or experimental group. Patients in the control group received an 18-month treatment regimen, whereas patients in the experimental group received a 12-month treatment regimen containing CFZ.
RESULTS


At the completion of the treatment period, the difference in sputum-culture conversion rates between the experimental group and the control group was not significant. Notably, by the end of 3 months of treatment, 68.7% patients receiving the experimental regimen had sputum-culture conversion, as compared with 55.9% of those receiving the control regimen; this was a significant difference, suggesting an early sputum conversion (P = .04). There were 67 adverse events reported in 56 patients in this study, including 32 in the control group and 35 in the experimental group. No significant difference in the overall incidences of adverse events was observed between the 2 groups.
CONCLUSIONS


The MDR-TB patients treated with the shorter regimen containing CFZ had a comparable successful outcome rate when compared to those with the standard regimen. The patients assigned to the experimental group achieved more rapid sputum-culture conversion, reflecting superior antimicrobial activity against MDR-TB.
CLINICAL TRIALS REGISTRATION


Chinese Clinical Trial Registry ChiCTR 1800020391.",2020,"The patients assigned in the experimental group achieve more rapid sputum culture conversion, reflecting the superior antimicrobial activity against MDR-TB.","['135 MDR-TB cases met eligibility requirements', 'multidrug-resistant tuberculosis', 'MDR-TB']","['CFZ', 'clofazimine (CFZ', 'clofazimine']","['rapid sputum culture conversion', 'early sputum conversion', 'sputum-culture conversion', 'successful outcome rate', 'overall incidence of adverse events', '67 adverse events']","[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0206526', 'cui_str': 'Tuberculosis, Multi-Drug Resistant'}]","[{'cui': 'C0008996', 'cui_str': 'Clofazimine'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0523174', 'cui_str': 'Microbial culture of sputum (procedure)'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0329544,"The patients assigned in the experimental group achieve more rapid sputum culture conversion, reflecting the superior antimicrobial activity against MDR-TB.","[{'ForeName': 'Yadong', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': ""Department of Tuberculosis, Beijing Chest Hospital of Capital Medical University, Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Qiu', 'Affiliation': ""Department of Drug-Resistant Tuberculosis, Jiamusi Tuberculosis Control Hospital, Jiamusi, People's Republic of China.""}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Tuberculosis, Fuzhou Pulmonary Hospital of Fujian, Fuzhou, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Tuberculosis, Beijing Chest Hospital of Capital Medical University, Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Jing', 'Affiliation': ""Department of Tuberculosis, Beijing Chest Hospital of Capital Medical University, Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Hongqiu', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': ""Department of Pulmonary,The Third People's Hospital of Zhenjiang, Zhenjiang, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""Department of Tuberculosis, Shenyang Chest Hospital, Liaoning Province Shenyang, People's Republic of China.""}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Chest, Qingdao Chest Hospital, Qingdao, People's Republic of China.""}, {'ForeName': 'Chunxiang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Tuberculosis, Changsha Central Hospital, Changsha, People's Republic of China.""}, {'ForeName': ""Xiu'e"", 'Initials': 'X', 'LastName': 'Xi', 'Affiliation': ""Department of Tuberculosis, Xinxiang Medical College Affiliated Hospital, Xinxiang, People's Republic of China.""}, {'ForeName': 'Hongyun', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': ""Clinic and Research Center of Tuberculosis, Shanghai Key Lab of Tuberculosis, Shanghai Pulmonary Hospital of Tongji University, Shanghai, People's Republic of China.""}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': ""Department of Pulmonary, The Third People's Hospital of Shenzhen, Shenzhen, People's Republic of China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Tuberculosis, Nanjing Chest Hospital, Nanjing, People's Republic of China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': ""Department of Epidemiology and Biostatistics, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences & School of Basic Medicine, Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Qingfeng', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Tuberculosis, Beijing Chest Hospital of Capital Medical University, Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Ru', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': ""Department of Tuberculosis, Beijing Chest Hospital of Capital Medical University, Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Tuberculosis, Beijing Chest Hospital of Capital Medical University, Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Pang', 'Affiliation': ""National Clinical Laboratory on Tuberculosis, Beijing Chest Hospital of Capital Medical University, Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Naihui', 'Initials': 'N', 'LastName': 'Chu', 'Affiliation': ""Department of Tuberculosis, Beijing Chest Hospital of Capital Medical University, Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People's Republic of China.""}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz915']
840,31549310,Cooperative parent-mediated therapy for Italian preschool children with autism spectrum disorder: a randomized controlled trial.,"Parent-mediated intervention is widely used for pre-schoolers with autism spectrum disorder (ASD). Previous studies indicate small-to-moderate effects on social communication skills, but with a wide heterogeneity that requires further research. In this randomized controlled trial (RCT), cooperative parent-mediated therapy (CPMT) an individual parent coaching program for young children with ASD was administered to preschool children with ASD. All children received the same low-intensity psychosocial intervention (LPI) delivered in community settings, to evaluate the potential additional benefit of CPMT. Thirty-four participants with ASD (7 females; 27 males; aged 2, 6, 11 years) and their parents were included in the trial. The primary blinded outcome was social communication skills, assessed using the ADOS-G social communication algorithm score (ADOS-G SC). Secondary outcomes included ASD symptom severity, parent-rated language abilities and emotional/behavioral problems, and self-reported caregiver stress. Evaluations were made at baseline and post-treatment (at 6 months) by an independent multidisciplinary team. Results documented that CPMT showed an additional benefit on LPI with significant improvements of the primary blinded outcome, socio-communication skills, and of some secondary outcomes such as ASD symptom severity, emotional problems and parental stress related to parent-child dysfunctional interaction. No additional benefit was found for language abilities. Findings of our RCT show that CPMT provide an additional significant short-term treatment benefit on ASD core symptoms, when compared with active control group receiving only LPI.",2020,No additional benefit was found for language abilities.,"['young children with ASD was administered to preschool children with ASD', 'Thirty-four participants with ASD (7 females; 27 males; aged 2, 6, 11\xa0years) and their parents were included in the trial', 'Italian preschool children with autism spectrum disorder']","['same low-intensity psychosocial intervention (LPI', 'cooperative parent-mediated therapy (CPMT', 'Cooperative parent-mediated therapy', 'CPMT']","['ASD symptom severity, parent-rated language abilities and emotional/behavioral problems, and self-reported caregiver stress', 'socio-communication skills', 'social communication skills, assessed using the ADOS-G social communication algorithm score (ADOS-G SC', 'ASD symptom severity, emotional problems and parental stress related to parent-child dysfunctional interaction', 'language abilities']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0233514', 'cui_str': 'Behavioral Problem'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0002045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems (finding)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",34.0,0.339734,No additional benefit was found for language abilities.,"[{'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Valeri', 'Affiliation': ""Department of Neuroscience, IRCCS Children's Hospital Bambino Gesù, Piazza Sant' Onofrio, 4 00165, Rome, Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Casula', 'Affiliation': ""Department of Neuroscience, IRCCS Children's Hospital Bambino Gesù, Piazza Sant' Onofrio, 4 00165, Rome, Italy.""}, {'ForeName': 'Deny', 'Initials': 'D', 'LastName': 'Menghini', 'Affiliation': ""Department of Neuroscience, IRCCS Children's Hospital Bambino Gesù, Piazza Sant' Onofrio, 4 00165, Rome, Italy.""}, {'ForeName': 'Filomena Alessandra', 'Initials': 'FA', 'LastName': 'Amendola', 'Affiliation': ""Department of Neuroscience, IRCCS Children's Hospital Bambino Gesù, Piazza Sant' Onofrio, 4 00165, Rome, Italy.""}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Napoli', 'Affiliation': ""Department of Neuroscience, IRCCS Children's Hospital Bambino Gesù, Piazza Sant' Onofrio, 4 00165, Rome, Italy.""}, {'ForeName': 'Patrizio', 'Initials': 'P', 'LastName': 'Pasqualetti', 'Affiliation': 'Service of Medical Statistics and Information Technology, Fatebenefratelli Foundation for Health Research and Education, Rome, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Vicari', 'Affiliation': ""Department of Neuroscience, IRCCS Children's Hospital Bambino Gesù, Piazza Sant' Onofrio, 4 00165, Rome, Italy. giovanni.valeri@opbg.net.""}]",European child & adolescent psychiatry,['10.1007/s00787-019-01395-5']
841,26085041,"Ziprasidone Augmentation of Escitalopram for Major Depressive Disorder: Efficacy Results From a Randomized, Double-Blind, Placebo-Controlled Study.","OBJECTIVE


The authors sought to test the efficacy of adjunctive ziprasidone in adults with nonpsychotic unipolar major depression experiencing persistent symptoms after 8 weeks of open-label treatment with escitalopram.
METHOD


This was an 8-week, randomized, double-blind, parallel-group, placebo-controlled trial conducted at three academic medical centers. Participants were 139 outpatients with persistent symptoms of major depression after an 8-week open-label trial of escitalopram (phase 1), randomly assigned in a 1:1 ratio to receive adjunctive ziprasidone (escitalopram plus ziprasidone, N=71) or adjunctive placebo (escitalopram plus placebo, N=68), with 8 weekly follow-up assessments. The primary outcome measure was clinical response, defined as a reduction of at least 50% in score on the 17-item Hamilton Depression Rating Scale (HAM-D). The Hamilton Anxiety Rating scale (HAM-A) and Visual Analog Scale for Pain were defined a priori as key secondary outcome measures.
RESULTS


Rates of clinical response (35.2% compared with 20.5%) and mean improvement in HAM-D total scores (-6.4 [SD=6.4] compared with -3.3 [SD=6.2]) were significantly greater for the escitalopram plus ziprasidone group. Several secondary measures of antidepressant efficacy also favored adjunctive ziprasidone. The escitalopram plus ziprasidone group also showed significantly greater improvement on HAM-A score but not on Visual Analog Scale for Pain score. Ten (14%) patients in the escitalopram plus ziprasidone group discontinued treatment because of intolerance, compared with none in the escitalopram plus placebo group.
CONCLUSIONS


Ziprasidone as an adjunct to escitalopram demonstrated antidepressant efficacy in adult patients with major depressive disorder experiencing persistent symptoms after 8 weeks of open-label treatment with escitalopram.",2015,The escitalopram plus ziprasidone group also showed significantly greater improvement on HAM-A score but not on Visual Analog Scale for Pain score.,"['adult patients with major depressive disorder experiencing persistent symptoms after 8 weeks of open-label treatment with escitalopram', 'Major Depressive Disorder', 'controlled trial conducted at three academic medical centers', 'adults with nonpsychotic unipolar major depression experiencing persistent symptoms after 8 weeks of open-label treatment with escitalopram', 'Participants were 139 outpatients with persistent symptoms of major depression after an 8-week open-label trial of escitalopram (phase 1']","['placebo', 'Placebo', 'adjunctive ziprasidone (escitalopram plus ziprasidone, N=71) or adjunctive placebo (escitalopram plus placebo', 'ziprasidone', 'Ziprasidone Augmentation of Escitalopram', 'Ziprasidone', 'adjunctive ziprasidone']","['Visual Analog Scale for Pain score', 'antidepressant efficacy', 'Hamilton Anxiety Rating scale (HAM-A) and Visual Analog Scale for Pain', 'Rates of clinical response', 'HAM-D total scores', 'clinical response, defined as a reduction of at least 50% in score on the 17-item Hamilton Depression Rating Scale (HAM-D', 'HAM-A score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0443340', 'cui_str': 'Unipolar (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0380393', 'cui_str': 'ziprasidone'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",139.0,0.397755,The escitalopram plus ziprasidone group also showed significantly greater improvement on HAM-A score but not on Visual Analog Scale for Pain score.,"[{'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'From the Massachusetts General Hospital Clinical Trials Network and Institute, the Massachusetts General Hospital Depression Clinical and Research Program, and Harvard Medical School, Boston; the Department of Psychiatry and Psychology, Mayo Medical School, Rochester, Minn.; the Department of Psychiatry and Behavioral Neurobiology, University of Alabama-Birmingham School of Medicine, Birmingham.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'From the Massachusetts General Hospital Clinical Trials Network and Institute, the Massachusetts General Hospital Depression Clinical and Research Program, and Harvard Medical School, Boston; the Department of Psychiatry and Psychology, Mayo Medical School, Rochester, Minn.; the Department of Psychiatry and Behavioral Neurobiology, University of Alabama-Birmingham School of Medicine, Birmingham.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Baer', 'Affiliation': 'From the Massachusetts General Hospital Clinical Trials Network and Institute, the Massachusetts General Hospital Depression Clinical and Research Program, and Harvard Medical School, Boston; the Department of Psychiatry and Psychology, Mayo Medical School, Rochester, Minn.; the Department of Psychiatry and Behavioral Neurobiology, University of Alabama-Birmingham School of Medicine, Birmingham.'}, {'ForeName': 'Michaela B', 'Initials': 'MB', 'LastName': 'Swee', 'Affiliation': 'From the Massachusetts General Hospital Clinical Trials Network and Institute, the Massachusetts General Hospital Depression Clinical and Research Program, and Harvard Medical School, Boston; the Department of Psychiatry and Psychology, Mayo Medical School, Rochester, Minn.; the Department of Psychiatry and Behavioral Neurobiology, University of Alabama-Birmingham School of Medicine, Birmingham.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Jaeger', 'Affiliation': 'From the Massachusetts General Hospital Clinical Trials Network and Institute, the Massachusetts General Hospital Depression Clinical and Research Program, and Harvard Medical School, Boston; the Department of Psychiatry and Psychology, Mayo Medical School, Rochester, Minn.; the Department of Psychiatry and Behavioral Neurobiology, University of Alabama-Birmingham School of Medicine, Birmingham.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Bobo', 'Affiliation': 'From the Massachusetts General Hospital Clinical Trials Network and Institute, the Massachusetts General Hospital Depression Clinical and Research Program, and Harvard Medical School, Boston; the Department of Psychiatry and Psychology, Mayo Medical School, Rochester, Minn.; the Department of Psychiatry and Behavioral Neurobiology, University of Alabama-Birmingham School of Medicine, Birmingham.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'From the Massachusetts General Hospital Clinical Trials Network and Institute, the Massachusetts General Hospital Depression Clinical and Research Program, and Harvard Medical School, Boston; the Department of Psychiatry and Psychology, Mayo Medical School, Rochester, Minn.; the Department of Psychiatry and Behavioral Neurobiology, University of Alabama-Birmingham School of Medicine, Birmingham.'}]",The American journal of psychiatry,['10.1176/appi.ajp.2015.14101251']
842,23817973,Phase II clinical study of modified FOLFOX7 (intermittent oxaliplatin administration) plus bevacizumab in patients with unresectable metastatic colorectal cancer-CRAFT study.,"PURPOSE


Continuous treatment with FOLFOX therapy is associated with peripheral nerve toxicity, and to improve this inconvenient side effect various methods of administration are being investigated. A regimen of intermittent oxaliplatin administration by continuous infusion therapy, i.e., modified FOLFOX7 (mFOLFOX7) + bevacizumab, was designed with the goal of alleviating severe peripheral nerve disorders and hematological toxicity. A phase II clinical study was conducted to evaluate the efficacy and safety of this regimen.
METHODS


Previously untreated patients were assigned to mFOLFOX7 (oxaliplatin 85 mg/m(2), levofolinate [l-LV] 200 mg/m(2), 5-fluorouracil [5-FU] 2400 mg/m(2)) + bevacizumab (5 mg/kg) administered every 2 weeks for 8 cycles, maintenance without oxaliplatin for 8 cycles, and reintroduction of mFOLFOX7 + bevacizumab for 8 cycles or until disease progression. Progression free survival (PFS) following the first dose (PFS 1) and following reintroduction of oxaliplatin (PFS 2) were used as indices for assessing the efficacy of intermittent administration.
RESULTS


Fifty-two patients were enrolled, with median age of 64 years (range, 36-74). Median PFS 1 was 11.8 months (95 % confidence interval [CI], 9.5 to 13.7), median time to treatment failure was 10.3 months (95 % CI, 5.6 to 12.1), percentage of patients with neutropenia of grade 3 or higher was 7.8 %, and percentage with peripheral nerve disorders was 3.9 %. Response rate was 50 %, and 84.4 % of patients who started modified simplified LV5FU2 + bevacizumab were reintroduced to oxaliplatin.
CONCLUSION


By excluding 5-FU bolus administration and administering bevacizumab continuously the mFOLFOX7 + bevacizumab regimen with preplanned withdrawal of oxaliplatin showed high tolerability and prevented severe peripheral neuropathy and neutropenia without reducing efficacy.",2013,"Response rate was 50 %, and 84.4 % of patients who started modified simplified LV5FU2 + bevacizumab were reintroduced to oxaliplatin.
","['patients with unresectable metastatic colorectal cancer-CRAFT study', 'Fifty-two patients were enrolled, with median age of 64 years (range, 36-74']","['mFOLFOX7 (oxaliplatin 85 mg/m(2), levofolinate [l-LV] 200 mg/m(2), 5-fluorouracil', 'bevacizumab', 'intermittent oxaliplatin', 'modified FOLFOX7 (intermittent oxaliplatin administration) plus bevacizumab', 'FOLFOX therapy', 'modified FOLFOX7 (mFOLFOX7) + bevacizumab', 'oxaliplatin', 'LV5FU2 + bevacizumab', 'oxaliplatin for 8 cycles, and reintroduction of mFOLFOX7 + bevacizumab', '5-FU] 2400 mg/m(2)) + bevacizumab']","['peripheral nerve disorders', 'median time to treatment failure', 'Response rate', 'efficacy and safety', 'Progression free survival (PFS', 'Median PFS', 'severe peripheral neuropathy and neutropenia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517656', 'cui_str': 'Two thousand four hundred'}]","[{'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3494202', 'cui_str': 'Time-to-Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}]",52.0,0.0417936,"Response rate was 50 %, and 84.4 % of patients who started modified simplified LV5FU2 + bevacizumab were reintroduced to oxaliplatin.
","[{'ForeName': 'Tohru', 'Initials': 'T', 'LastName': 'Tezuka', 'Affiliation': 'Department of Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara City, Chiba, Japan, 299-0111, tohru_tezuka@tokyo-hmt.jp.'}, {'ForeName': 'Chikuma', 'Initials': 'C', 'LastName': 'Hamada', 'Affiliation': ''}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Ishida', 'Affiliation': ''}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Ooshiro', 'Affiliation': ''}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Matsuoka', 'Affiliation': ''}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Kawasaki', 'Affiliation': ''}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Mishima', 'Affiliation': ''}, {'ForeName': 'Kotaro', 'Initials': 'K', 'LastName': 'Maeda', 'Affiliation': ''}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Sakamoto', 'Affiliation': ''}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Koda', 'Affiliation': ''}]",Investigational new drugs,['10.1007/s10637-013-9982-3']
843,31884313,"The effects of thalamic and posterior subthalamic deep brain stimulation on speech in patients with essential tremor - A prospective, randomized, doubleblind crossover study.","OBJECTIVE


To prospectively evaluate the effect of PSA- and VIM DBS on speech in ET patients.
METHODS


Leads were implanted bilaterally with contacts placed in both VIM and PSA. Thirteen patients were analyzed pre- and postoperatively. Preoperative speech of ET patients was compared to healthy controls. PSA- and VIM-DBS were evaluated in a randomized, double-blind crossover phase.
RESULTS


At preoperative baseline, we found reduced intelligibility. Differences in acoustic and VAS data ('ability to speak') compared to controls were gradient. Articulation rate could be predicted by disease duration. Decreased articulation rate, spirantization and voicing were found for PSA- and VIM-DBS. Targets did not differ in terms of speech deterioration.
CONCLUSION


Speech in ET patients without DBS can be impaired, dependent on patient's individual characteristics. Both PSA- and VIM-DBS affect speech in a comparable way. Thus, the PSA can be considered an alternative DBS target in ET without higher risk of dysarthria.",2020,"Decreased articulation rate, spirantization and voicing were found for PSA- and VIM-DBS.","['ET patients', 'patients with essential tremor ']","['PSA- and VIM DBS', 'thalamic and posterior subthalamic deep brain stimulation']","['Articulation rate', 'Decreased articulation rate, spirantization and voicing', 'reduced intelligibility', 'PSA- and VIM-DBS', ""acoustic and VAS data ('ability to speak""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0270736', 'cui_str': 'Benign Essential Tremor'}]","[{'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0394162', 'cui_str': 'Deep Brain Stimulation'}]","[{'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0589416', 'cui_str': 'Intelligibility, function (observable entity)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0564214', 'cui_str': 'Ability to speak (observable entity)'}]",,0.0238303,"Decreased articulation rate, spirantization and voicing were found for PSA- and VIM-DBS.","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Becker', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Kerpener Str. 62, 50937 Cologne, Germany.'}, {'ForeName': 'Tabea', 'Initials': 'T', 'LastName': 'Thies', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Kerpener Str. 62, 50937 Cologne, Germany; University of Cologne, Faculty of Arts and Humanities, Department of Linguistics, IfL Phonetics, Herbert-Lewin-Str 6, 50931 Cologne, Germany.'}, {'ForeName': 'Jan Niklas', 'Initials': 'JN', 'LastName': 'Petry-Schmelzer', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Kerpener Str. 62, 50937 Cologne, Germany.'}, {'ForeName': 'Till A', 'Initials': 'TA', 'LastName': 'Dembek', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Kerpener Str. 62, 50937 Cologne, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Reker', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Kerpener Str. 62, 50937 Cologne, Germany.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Mücke', 'Affiliation': 'University of Cologne, Faculty of Arts and Humanities, Department of Linguistics, IfL Phonetics, Herbert-Lewin-Str 6, 50931 Cologne, Germany.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Grice', 'Affiliation': 'University of Cologne, Faculty of Arts and Humanities, Department of Linguistics, IfL Phonetics, Herbert-Lewin-Str 6, 50931 Cologne, Germany.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Visser-Vandewalle', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Stereotactic and Functional Neurosurgery, Kerpener Str. 62, 50937 Cologne, Germany.'}, {'ForeName': 'Gereon R', 'Initials': 'GR', 'LastName': 'Fink', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Kerpener Str. 62, 50937 Cologne, Germany; Research Center Jülich, Cognitive Neuroscience, Institute of Neuroscience and Medicine (INM-3), Leo-Brandt-Straße, 52425 Jülich, Germany.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Barbe', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Kerpener Str. 62, 50937 Cologne, Germany. Electronic address: michael.barbe@uk-koeln.de.'}]",Brain and language,['10.1016/j.bandl.2019.104724']
844,25555626,Academic Outcomes Following a School-Based RCT for ADHD: 6-Year Follow-Up.,"Objective:  For children with high levels of ADHD symptoms, to investigate the impact of early school-based interventions on academic outcomes in mid-childhood.  Method:  A 6-year follow-up of 4- to 5-year-olds ( N  = 52,075) whose schools participated in a cluster randomized controlled trial for children at risk of ADHD. School-level interventions involved the provision of a booklet with evidence-based information (book) and/or feedback of names (identification) of children with high levels of ADHD symptoms. At ages 10 to 11 years, outcome measures were scores in English and mathematics tests.  Results:  For children with high levels of ADHD symptoms, the interventions had no impact on academic outcomes. When all children were analyzed, the book intervention had a positive impact on mathematics. Baseline inattention was associated with poorer academic outcomes, whereas impulsiveness was associated with better academic outcomes.  Conclusion:  The provision of evidence-based information about helping children with ADHD at school may have wider academic benefits.",2020,"Baseline inattention was associated with poorer academic outcomes, whereas impulsiveness was associated with better academic outcomes.
","['A 6-year follow-up of 4- to 5-year-olds (N = 52,075) whose schools participated in a cluster randomized controlled trial for children at risk of ADHD', 'children with high levels of ADHD symptoms']","['School-Based RCT for ADHD', 'booklet with evidence-based information (book) and/or feedback of names (identification']",['scores in English and mathematics tests'],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0425119', 'cui_str': 'Child at risk (finding)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C4522128', 'cui_str': 'Name (property)'}, {'cui': 'C0020792', 'cui_str': 'Identification'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",52075.0,0.071229,"Baseline inattention was associated with poorer academic outcomes, whereas impulsiveness was associated with better academic outcomes.
","[{'ForeName': 'Kapil', 'Initials': 'K', 'LastName': 'Sayal', 'Affiliation': 'University of Nottingham, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Merrell', 'Affiliation': 'Durham University, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Tymms', 'Affiliation': 'Durham University, UK.'}, {'ForeName': 'Adetayo', 'Initials': 'A', 'LastName': 'Kasim', 'Affiliation': 'Durham University, UK.'}]",Journal of attention disorders,['10.1177/1087054714562588']
845,25872925,Investigating the non-specific effects of BCG vaccination on the innate immune system in Ugandan neonates: study protocol for a randomised controlled trial.,"BACKGROUND


The potential for Bacillus Calmette-Guérin (BCG) vaccination to protect infants against non-mycobacterial disease has been suggested by a randomised controlled trial conducted in low birth-weight infants in West Africa. Trials to confirm these findings in healthy term infants, and in a non-West African setting, have not yet been carried out. In addition, a biological mechanism to explain such heterologous effects of BCG in the neonatal period has not been confirmed. This trial aims to address these issues by evaluating whether BCG non-specifically enhances the innate immune system in term Ugandan neonates, leading to increased protection from a variety of infectious diseases.
METHODS


This trial will be an investigator-blinded, randomised controlled trial of 560 Ugandan neonates, comparing those receiving BCG at birth with those receiving BCG at 6 weeks of age. This design allows comparison of outcomes between BCG-vaccinated and -naïve infants until 6 weeks of age, and between early and delayed BCG-vaccinated infants from 6 weeks of age onwards. The primary outcomes of the study will be a panel of innate immune parameters. Secondary outcomes will include clinical illness measures.
DISCUSSION


Investigation of the possible broadly protective effects of neonatal BCG immunisation, and the optimal vaccination timing to produce these effects, could have profound implications for public healthcare policy. Evidence of protection against heterologous pathogens would underscore the importance of prioritising BCG administration in a timely manner for all infants, provide advocacy against the termination of BCG's use and support novel anti-tuberculous vaccine strategies that would safeguard such beneficial effects.
TRIAL REGISTRATION


ISRCTN59683017 : registration date: 15 January 2014.",2015,"This trial aims to address these issues by evaluating whether BCG non-specifically enhances the innate immune system in term Ugandan neonates, leading to increased protection from a variety of infectious diseases.
","['low birth-weight infants in West Africa', '560 Ugandan neonates, comparing those receiving BCG at birth with those receiving BCG at 6\xa0weeks of age', 'healthy term infants', 'infants until 6\xa0weeks of age, and between early and delayed BCG-vaccinated infants from 6\xa0weeks of age onwards', 'Ugandan neonates']","['BCG-vaccinated and -naïve', 'Bacillus Calmette-Guérin (BCG) vaccination', 'BCG vaccination']","['clinical illness measures', 'panel of innate immune parameters']","[{'cui': 'C0021288', 'cui_str': 'Low Birth Weight Infant'}, {'cui': 'C0001747', 'cui_str': 'West Africa'}, {'cui': 'C0241520', 'cui_str': 'Ugandans (ethnic group)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0085957', 'cui_str': 'BCG'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0085957', 'cui_str': 'BCG'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0199804', 'cui_str': 'BCG immunization'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",560.0,0.326631,"This trial aims to address these issues by evaluating whether BCG non-specifically enhances the innate immune system in term Ugandan neonates, leading to increased protection from a variety of infectious diseases.
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Prentice', 'Affiliation': 'Wellcome Trust - Bloomsbury Centre for Global Health Research, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. Sarah.prentice@lshtm.ac.uk.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Webb', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. Emily.webb@lshtm.ac.uk.'}, {'ForeName': 'Hazel M', 'Initials': 'HM', 'LastName': 'Dockrell', 'Affiliation': 'Wellcome Trust - Bloomsbury Centre for Global Health Research, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. Hazel.dockrell@lshtm.ac.uk.'}, {'ForeName': 'Pontiano', 'Initials': 'P', 'LastName': 'Kaleebu', 'Affiliation': 'MRC/Uganda Virus Research Institute on AIDS, Plot 51-59, Nakiwogo Road, PO Box 49, Entebbe, Uganda. pontiano.kaleebu@mrcuganda.org.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Elliott', 'Affiliation': 'Wellcome Trust - Bloomsbury Centre for Global Health Research, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. alison.elliott@mrcuganda.org.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Cose', 'Affiliation': 'Department of Infection and Immunology, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. Stephen.cose@lshtm.ac.uk.'}]",Trials,['10.1186/s13063-015-0682-5']
846,30543140,Sleep hygiene in adolescents with asthma.,"Objective:  Youth with asthma are at-risk for sleep difficulties due to nocturnal asthma symptoms. Sleep hygiene, or the ability to practice consistent sleep behaviors and habits, impacts youth sleep quality and may, as a result, influence daytime cognitive functioning. The current study sought to examine the impact sleep hygiene has on sleep quality, health-related quality of life (HRQL) and sustained attention among adolescents with asthma. It was hypothesized that worse sleep hygiene would be associated with poorer sleep quality, lower school-related and overall HRQL and worse sustained attention.  Methods:  Participants included 41 adolescents with persistent asthma ( M age  = 14.83, SD = 1.28; 51.2% male) recruited from a pediatric pulmonology clinic. Participants completed the adolescent sleep hygiene scale (ASHS), Adolescent Sleep Wake Scale (ASWS) and the Pediatric Quality of Life Index 4.0 generic core scales (PedsQL). Participants also completed the psychomotor vigilance task (PVT), an objective test of sustained attention.  Results:  Higher sleep hygiene scores were related to higher reported sleep quality ( β  = 0.377,  p  = 0.015,  f 2  = 0.166), higher reported school-related HRQL ( β  = 0.321,  p  = 0.040,  f 2  = 0.115) and better sustained attention ( β  = 0.327,  p  = 0.045,  f 2  = 0.120).  Conclusions:  Sleep hygiene may be an important factor in sleep quality and deficits in daytime dysfunction including sustained attention and school-related quality of life. As adolescents with asthma are at heightened risk for these outcomes associated with disturbed sleep, sleep hygiene may serve as an important domain for clinical intervention.",2020,"It was hypothesized that worse sleep hygiene would be associated with poorer sleep quality, lower school-related and overall HRQL and worse sustained attention.
","['Participants included 41 adolescents with persistent asthma (M age \u2009=\u200914.83, SD\u2009=\u20091.28; 51.2% male) recruited from a pediatric pulmonology clinic', 'adolescents with asthma']",[],"['psychomotor vigilance task (PVT', 'worse sleep hygiene', 'sleep quality, health-related quality of life (HRQL', 'sleep hygiene scores', 'adolescent sleep hygiene scale (ASHS), Adolescent Sleep Wake Scale (ASWS) and the Pediatric Quality of Life Index 4.0 generic core scales (PedsQL', 'Sleep hygiene', 'poorer sleep quality, lower school-related and overall HRQL and worse sustained attention', 'sleep quality']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1635023', 'cui_str': 'Pediatric pulmonology'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]",[],"[{'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0222045'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index (assessment scale)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",41.0,0.0431807,"It was hypothesized that worse sleep hygiene would be associated with poorer sleep quality, lower school-related and overall HRQL and worse sustained attention.
","[{'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Lawless', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Elise M', 'Initials': 'EM', 'LastName': 'Turner', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'LeFave', 'Affiliation': 'Pediatric Pulmonary and Allergy Division, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Koinis-Mitchell', 'Affiliation': ""Bradley/Hasbro Children's Research Center, Brown University, Providence, RI, USA.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Fedele', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2018.1553049']
847,31972593,Mitomycin C-augmented Phacotrabeculectomy Versus Phacoemulsification in Primary Angle-closure Glaucoma: A Randomized Controlled Study.,,2020,,['Primary Angle-closure Glaucoma'],['Mitomycin C-augmented Phacotrabeculectomy Versus Phacoemulsification'],[],"[{'cui': 'C0017606', 'cui_str': 'Primary angle-closure glaucoma (disorder)'}]","[{'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1167708', 'cui_str': 'Phacotrabeculectomy'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}]",[],,0.0798094,,"[{'ForeName': 'Mayuri', 'Initials': 'M', 'LastName': 'Borgohain', 'Affiliation': 'Sri Sankaradeva Nethralaya, Guwahati Assam, India.'}, {'ForeName': 'Shahinur', 'Initials': 'S', 'LastName': 'Tayab', 'Affiliation': ''}, {'ForeName': 'Prafulla', 'Initials': 'P', 'LastName': 'Sarma', 'Affiliation': ''}, {'ForeName': 'Chengchira A', 'Initials': 'CA', 'LastName': 'Sangma', 'Affiliation': ''}, {'ForeName': 'Nitu', 'Initials': 'N', 'LastName': 'Kumari', 'Affiliation': ''}, {'ForeName': 'Palak', 'Initials': 'P', 'LastName': 'Chiraniya', 'Affiliation': ''}]",Journal of glaucoma,['10.1097/IJG.0000000000001433']
848,24981241,Non-randomized controlled prospective study on perioperative levels of stress and dysautonomia during dental implant surgery.,"PURPOSE


The purpose of this study was to compare pre- and postoperative autonomic activities and changes in salivary stress biomarkers between patients who received only local anesthesia and those who received local anesthesia together with intravenous sedation in dental implant surgery.
METHODS


A total of 21 patients were enrolled in this non-randomized controlled prospective study; 7 subjects underwent implant surgery under local anesthesia with intravenous sedation and 14 subjects underwent surgery under only local anesthesia. Stress was evaluated by measuring salivary levels of chromogranin A (CgA) and a spectral analysis of heart rate variability (HRV) at baseline (on a day other than the day of surgery), 1h preoperatively, and 1h postoperatively. HRV analysis yields low- (LF) and high-frequency (HF) components, the LF/HF ratio, and the component coefficient of variance (CCV[HF]), which provide indices of sympathetic and parasympathetic regulatory activity.
RESULTS


CgA levels were significantly higher (p<0.05) at baseline in patients who received sedation than those who did not, but CgA levels did not differ prior to surgery. Also, the values of most parameters, including LF, HF, LF/HF (L/H), and CCV(HF), did not significantly differ between groups or among the three time points. Only ΔL/H and ΔCCV(HF) were significantly lower (p<0.05) at 1h preoperatively in patients who received sedation than those who received only local anesthesia.
CONCLUSIONS


CgA levels were high in both groups immediately before surgery, and thus CgA values immediately before surgery may not be a reliable indicator of the need for intravenous sedation. Also, spectral analysis of HRV, especially ΔL/H and ΔCCV(HF), could be useful for assessing tension and anxiety.",2014,"RESULTS


CgA levels were significantly higher (p<0.05) at baseline in patients who received sedation than those who did not, but CgA levels did not differ prior to surgery.","['21 patients', 'patients who received only local anesthesia and those who received local anesthesia together with intravenous sedation in dental implant surgery']","['dental implant surgery', 'implant surgery under local anesthesia with intravenous sedation and 14 subjects underwent surgery under only local anesthesia']","['LF, HF, LF/HF (L/H), and CCV(HF', 'CgA levels', 'salivary levels of chromogranin A (CgA) and a spectral analysis of heart rate variability (HRV', 'salivary stress biomarkers']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0412775', 'cui_str': 'Intravenous sedation (procedure)'}, {'cui': 'C0011373', 'cui_str': 'Dental Implants'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0011373', 'cui_str': 'Dental Implants'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0412775', 'cui_str': 'Intravenous sedation (procedure)'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}]","[{'cui': 'C2346686', 'cui_str': 'L/h'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0055633', 'cui_str': 'Secretory Protein I, Parathyroid Gland'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",21.0,0.0451669,"RESULTS


CgA levels were significantly higher (p<0.05) at baseline in patients who received sedation than those who did not, but CgA levels did not differ prior to surgery.","[{'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Morino', 'Affiliation': 'Department of Oral Reconstruction and Rehabilitation, Kyushu Dental University, Graduate School, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Masaki', 'Affiliation': 'Department of Oral Reconstruction and Rehabilitation, Kyushu Dental University, Graduate School, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Seo', 'Affiliation': 'Department of Oral Reconstruction and Rehabilitation, Kyushu Dental University, Graduate School, Japan.'}, {'ForeName': 'Chisato', 'Initials': 'C', 'LastName': 'Mukai', 'Affiliation': 'Department of Oral Reconstruction and Rehabilitation, Kyushu Dental University, Graduate School, Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Mukaibo', 'Affiliation': 'Department of Oral Reconstruction and Rehabilitation, Kyushu Dental University, Graduate School, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Kondo', 'Affiliation': 'Department of Oral Reconstruction and Rehabilitation, Kyushu Dental University, Graduate School, Japan.'}, {'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Shiiba', 'Affiliation': 'Department of Dental Anesthesiology, Kyushu Dental University, Japan.'}, {'ForeName': 'Tetsuji', 'Initials': 'T', 'LastName': 'Nakamoto', 'Affiliation': 'Department of Oral Reconstruction and Rehabilitation, Kyushu Dental University, Graduate School, Japan.'}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Hosokawa', 'Affiliation': 'Department of Oral Reconstruction and Rehabilitation, Kyushu Dental University, Graduate School, Japan. Electronic address: hosokawa@kyu-dent.ac.jp.'}]",Journal of prosthodontic research,['10.1016/j.jpor.2014.03.006']
849,25168656,Marginal fit and microleakage of cast and metal laser sintered copings--an in vitro study.,"PURPOSE


This study aimed to compare the marginal fit and microleakage of metal laser sintered Co-Cr alloy copings and conventional cast Ni-Cr alloy copings using a stereomicroscope.
METHODS


Forty extracted maxillary premolars were randomly divided into two groups. One group was subjected to coping fabrication using conventional lost wax (LW) technique while the other group was subjected to coping fabrication using metal laser sintering (MLS) technology. The marginal fit of these copings were compared before and after ceramic addition using images obtained with a steromicroscope and an ImageJ analysis software. All the specimens were cemented using Type 1 glass ionomer cement and were subjected to thermocycling. The specimens were evaluated for microleakage using stereomicroscope and 2% methylene blue die used as a tracer. The data were subjected to statistical analysis using paired t-test, Mann-Whitney test and Chi-Square test.
RESULTS


The mean marginal fit of copings before and after ceramic addition in Group B (MLS) was better than the copings in Group A (LW) and was statistically significant (P<0.05). The influence of ceramic firing had a significant (P<0.05) increase in mean marginal gap in Group A (LW) but not in Group B (MLS). And the difference in mean microleakage between the groups was not statistically significant (P≥0.05).
CONCLUSION


The copings fabricated using MLS technique had a better marginal fit and an observable decrease in microleakage when compared to the copings fabricated using the conventional lost wax (LW) technique.",2014,The influence of ceramic firing had a significant (P<0.05) increase in mean marginal gap in Group A (LW) but not in Group B (MLS).,['Forty extracted maxillary premolars'],"['coping fabrication using conventional lost wax (LW) technique while the other group was subjected to coping fabrication using metal laser sintering (MLS) technology', 'metal laser sintered Co-Cr alloy copings and conventional cast Ni-Cr alloy copings']","['mean marginal gap', 'mean microleakage', 'mean marginal fit of copings']","[{'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0740486', 'cui_str': 'Ear Wax'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002154', 'cui_str': 'Alloys'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}]",40.0,0.0213488,The influence of ceramic firing had a significant (P<0.05) increase in mean marginal gap in Group A (LW) but not in Group B (MLS).,"[{'ForeName': 'Manoj Kumar', 'Initials': 'MK', 'LastName': 'Sundar', 'Affiliation': 'Department of Prosthodontics, V.S. Dental College & Hospital, K.R. Road, V.V. Puram, Bangalore 560004, Karnataka, India. Electronic address: manojs87@gmail.com.'}, {'ForeName': 'Satish Babu', 'Initials': 'SB', 'LastName': 'Chikmagalur', 'Affiliation': 'Department of Prosthodontics, V.S. Dental College & Hospital, K.R. Road, V.V. Puram, Bangalore 560004, Karnataka, India. Electronic address: drclsatishbabu@gmail.com.'}, {'ForeName': 'Fayaz', 'Initials': 'F', 'LastName': 'Pasha', 'Affiliation': 'Department of Prosthodontics, V.S. Dental College & Hospital, K.R. Road, V.V. Puram, Bangalore 560004, Karnataka, India. Electronic address: fayazpasha2000@yahoo.co.in.'}]",Journal of prosthodontic research,['10.1016/j.jpor.2014.07.002']
850,23869890,Effects of lower body positive pressure on cardiovascular responses during walking in elderly women.,"This study was undertaken to investigate the effects of lower body positive pressure (LBPP) on cardiovascular responses during a 15-min walking trial in young (22.1+/-0.4 years) and elderly women (67.8+/-1.1 years). The application of 20 mm Hg LBPP reduced ground reaction forces by 31.2+/-0.5 kgw in both groups. We hypothesized that cardiovascular responses to LBPP during walking were different between the young and elderly subjects. Applying 20 mm Hg of LBPP increased diastolic and mean blood pressure but not systolic blood pressure in both groups. LBPP-induced reduction in heart rate (HR) occurred more quickly in the young group compared to the elderly group (p<0.05). Applying LBPP also decreased double product (systolic blood pressure x HR) in both groups, suggesting that LBPP reduces myocardial oxygen consumption during exercise. These results suggest that heart rate responses to LBPP during exercise vary with increasing age.",2013,LBPP-induced reduction in heart rate (HR) occurred more quickly in the young group compared to the elderly group (p<0.05).,"['young (22.1+/-0.4 years) and elderly women (67.8+/-1.1 years', 'elderly women', 'young and elderly subjects']","['LBPP', 'lower body positive pressure', 'lower body positive pressure (LBPP']","['ground reaction forces', 'systolic blood pressure', 'heart rate (HR', 'cardiovascular responses', 'double product (systolic blood pressure x HR', 'diastolic and mean blood pressure', 'myocardial oxygen consumption']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman (person)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0428863', 'cui_str': 'Myocardial oxygen consumption (observable entity)'}]",,0.0327449,LBPP-induced reduction in heart rate (HR) occurred more quickly in the young group compared to the elderly group (p<0.05).,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sota', 'Affiliation': 'Department of Rehabilitation, Tottori University Hospital, Yonago, Japan. tsota@med.tottori-u.ac.jp.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Matsuo', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Uchida', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hagino', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Kawai', 'Affiliation': ''}]",Physiological research,[]
851,32418236,Post-treatment endodontic pain following occlusal reduction in mandibular posterior teeth with symptomatic irreversible pulpitis and sensitivity to percussion: a single-centre randomized controlled trial.,"AIM


This randomized, prospective, controlled trial assessed the effect of occlusal reduction on post-treatment endodontic pain and medication intake following root canal treatment of mandibular posterior teeth with symptomatic irreversible pulpitis with sensitivity to percussion treated in two visits.
METHODOLOGY


Three hundred and eight patients were randomly assigned into two equal groups according to whether occlusal reduction was done or not (n = 154). For all patients, root canal treatment was carried out in two visits without intracanal medication. Patients assessed their pain using the 0-10 numerical rating scale (NRS) 6, 12, 24 and 48 h after the first visit (post-instrumentation) and 6 and 12 h following root canal filling (post-obturation). Patients, also, recorded their medication intake (sham or analgesic), post-instrumentation and post-obturation; patients initially received a sham capsule, but, if pain persisted, an analgesic was prescribed. Data were analysed using Mann-Whitney U-test, Friedman's test, Wilcoxon's rank test and chi-square (χ 2  ) test. The relative risk (RR) and its 95% confidence interval (CI) were calculated for binary data.
RESULTS


Occlusal reduction was associated with lower pain intensity than no occlusal reduction at 12 and 24 h post-instrumentation (P < 0.05). Pain intensity significantly and gradually decreased with both groups at all post-instrumentation and post-obturation time-points compared to preoperative pain (P < 0.05). The RR of moderate-to-severe pain was 0.61 (95% CI: 0.41, 0.91) 12 h post-instrumentation, and the RR of pain incidence, regardless of its level, was 0.75 (95% CI: 0.61, 0.92) 24 h post-instrumentation. There was no significant difference in medication intake (sham or analgesic) between groups (P > 0.05).
CONCLUSIONS


Occlusal reduction was effective in reducing the intensity of postoperative pain 12 h and 24 h after root canal instrumentation in the first visit in patients with symptomatic irreversible pulpitis with sensitivity to percussion. Occlusal reduction lowered the risk of moderate-to-severe pain by about 40% 12 h post-instrumentation and the overall risk of pain by 25% 24 h post-instrumentation; yet, it did not affect medication intake.",2020,Pain intensity significantly and gradually decreased with both groups at all postinstrumentation and postobturation timepoints compared to preoperative pain (p<0.05).,"['mandibular posterior teeth with symptomatic irreversible pulpitis and sensitivity to percussion', 'Three hundred and eight patients', 'mandibular posterior teeth with symptomatic irreversible pulpitis with sensitivity to percussion treated in two visits', 'patients with symptomatic irreversible pulpitis with sensitivity to percussion']","['occlusal reduction', 'root canal treatment']","['Postendodontic pain', 'pain intensity', 'postendodontic pain and medication intake', 'Pain intensity', 'Relative Risk (RR) and its 95% confidence interval (CI', 'RR of pain incidence', 'intensity of postoperative pain', 'overall risk of pain', 'RR of moderate-to-severe pain', 'risk of moderate-to-severe pain', 'medication intake']","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C4039735', 'cui_str': 'Symptomatic irreversible pulpitis'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0030987', 'cui_str': 'Percussion'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]",308.0,0.181418,Pain intensity significantly and gradually decreased with both groups at all postinstrumentation and postobturation timepoints compared to preoperative pain (p<0.05).,"[{'ForeName': 'Y E', 'Initials': 'YE', 'LastName': 'Ahmed', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Emara', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Sarhan', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'El Boghdadi', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'M A A', 'Initials': 'MAA', 'LastName': 'El-Bayoumi', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'H M M', 'Initials': 'HMM', 'LastName': 'El-Far', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'Sabet', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Abou El-Nasr', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'S I', 'Initials': 'SI', 'LastName': 'Gawdat', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'S A W', 'Initials': 'SAW', 'LastName': 'Amin', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}]",International endodontic journal,['10.1111/iej.13328']
852,31541718,Changes in Pain-Related Fear and Pain When Avoidance Behavior is no Longer Effective.,"Avoidance is considered key in the development of chronic pain. However, little is known about how avoidance behavior subsequently affects pain-related fear and pain. We investigated this using a robotic arm reaching avoidance task. In a between-subjects design both Experimental Group (n = 30) and Yoked Control Group (n = 30) participants perform either of 3 movement trajectories (T1-T3) to reach a target location. During acquisition, only participants of the Experimental Group could partially or fully avoid a painful electrocutaneous stimulus by choosing the intermediate trajectory (T2; 50% reinforcement) or the longest trajectory (T3; 0% reinforcement) versus the shortest trajectory (T1: 100% reinforcement). After acquisition, contingencies changed (all trajectories 50% reinforced), and the acquired avoidance behavior no longer effectively prevented pain from occurring. The Yoked Control Group received the same reinforcement schedule as the Experimental Group irrespective of their behavior. When avoidance behavior became ineffective for the Experimental Group, pain-related fear increased for the previously safe(r) trajectories (T2 and T3) and remained the same for T1, whereas pain threshold and tolerance declined. For the Yoked Group, pain-related fear increased for all trajectories. The Experimental Group persisted in emitting avoidance behavior following the contingency change, albeit at a lower frequency than during acquisition. PERSPECTIVE: Results indicate participants become more afraid of and sensitive to pain, when previously acquired avoidance is no longer effective. Also, participants continue to show avoidance behavior despite it being not adaptive anymore. These findings suggest that ineffective avoidance may play role in the maintenance and development of chronic pain.",2020,"When avoidance behaviour became ineffective for the Experimental Group, pain-related fear increased for the previously safe(r) trajectories (T2 and T3) and remained the same for T1, whereas pain threshold and tolerance declined.",[],[],"['pain-related fear and pain', 'pain-related fear', 'pain', 'emitting avoidance behaviour']",[],[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0178494', 'cui_str': 'Avoidance Behavior'}]",,0.0424807,"When avoidance behaviour became ineffective for the Experimental Group, pain-related fear increased for the previously safe(r) trajectories (T2 and T3) and remained the same for T1, whereas pain threshold and tolerance declined.","[{'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'van Vliet', 'Affiliation': 'Research Group Health Psychology, KU Leuven, Leuven, Belgium; Experimental Health Psychology, Maastricht University, Maastricht, The Netherlands. Electronic address: christine.vanvliet@kuleuven.be.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Meulders', 'Affiliation': 'Research Group Health Psychology, KU Leuven, Leuven, Belgium; Experimental Health Psychology, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Linda M G', 'Initials': 'LMG', 'LastName': 'Vancleef', 'Affiliation': 'Experimental Health Psychology, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Meyers', 'Affiliation': 'Research Group Health Psychology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Johan W S', 'Initials': 'JWS', 'LastName': 'Vlaeyen', 'Affiliation': 'Research Group Health Psychology, KU Leuven, Leuven, Belgium; Experimental Health Psychology, Maastricht University, Maastricht, The Netherlands.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.09.002']
853,32492920,"Comparisons between Manual Lymph Drainage, Abdominal Massage, and Electrical Stimulation on Functional Constipation Outcomes: A Randomized, Controlled Trial.","BACKGROUND


Evidence supports abdominal massage (AM) or electrical stimulation (ES) as effective in treating functional constipation (FC). Manual lymph drainage (MLD) may also be beneficial, however, it was not previously investigated or compared to ES and AM.
METHODS


Sixteen college-aged males and 36 females were recruited. Participants were randomly assigned to MLD, AM or ES. Heart rate variability (HRV) measures for total power (TP), high frequency (HF), low frequency and LF/HF ratio assessed ANS outcomes. state-trait anxiety inventory (STAI) and stress response inventory (SRI) assessed psychological factors and bowel movement frequency (BMF) and duration (BMD) were recorded daily.
RESULTS


MLD significantly improved all ANS measures (p≤0.01); AM significantly improved LF, HF and LF/HF ratios (p = 0.04); and ES significantly improved LF (p = 0.1). STAI measures improved, but not significantly in all groups. SRI improved significantly from MLD (p < 0.01), AM (p = 0.04) and ES (p < 0.01), but changes were not significant between groups. BMD improved significantly in all groups (p≤ 0.02). BMF improved significantly only following MLD and AM (p < 0.1), but differences between groups were not significant (p = 0.39).
CONCLUSIONS


MLD significantly reduced FC symptoms and MLD had greater improvements than AM or ES.",2020,"RESULTS


MLD significantly improved all ANS measures (p≤0.01); AM significantly improved LF, HF and LF/HF ratios (p = 0.04); and ES significantly improved LF (p = 0.1).",['Sixteen college-aged males and 36 females were recruited'],"['Manual Lymph Drainage, Abdominal Massage, and Electrical Stimulation', 'MLD, AM or ES', 'Manual lymph drainage (MLD', 'abdominal massage (AM) or electrical stimulation (ES']","['SRI', 'Functional Constipation Outcomes', 'FC symptoms and MLD', 'BMF', 'Heart rate variability (HRV) measures for total power (TP), high frequency (HF), low frequency and LF/HF ratio assessed ANS outcomes', 'STAI measures', 'BMD', 'LF, HF and LF/HF ratios', 'state-trait anxiety inventory (STAI) and stress response inventory (SRI) assessed psychological factors and bowel movement frequency (BMF) and duration (BMD']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0556834', 'cui_str': 'Manual lymphatic drainage'}, {'cui': 'C2316341', 'cui_str': 'Massage of abdomen'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0556834', 'cui_str': 'Manual lymphatic drainage'}, {'cui': 'C0426642', 'cui_str': 'Frequency of bowel action'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0033898', 'cui_str': 'Factors, Psychological'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",36.0,0.135208,"RESULTS


MLD significantly improved all ANS measures (p≤0.01); AM significantly improved LF, HF and LF/HF ratios (p = 0.04); and ES significantly improved LF (p = 0.1).","[{'ForeName': 'Jacqueline S', 'Initials': 'JS', 'LastName': 'Drouin', 'Affiliation': 'School of Health Sciences, Oakland University, 433 Meadow Brook Road, Rochester, MI 48309-4451, USA.'}, {'ForeName': 'Lucinda', 'Initials': 'L', 'LastName': 'Pfalzer', 'Affiliation': 'Physical Therapy Department, University of Michigan-Flint, 2157 WSW Bldg., Flint, MI 48502-195, USA.'}, {'ForeName': 'Jung Myo', 'Initials': 'JM', 'LastName': 'Shim', 'Affiliation': 'Department of Skin and Health Care, Suseong University, 15 Dalgubeol-daero 528-gil, Suseong-gu, Daegu 13557, Korea.'}, {'ForeName': 'Seong Jung', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, College of Health and Science, Kangwon National University, 346, Hwangjo-gil, Dogye-eup, Samcheok-si, Gangwon-do 24341, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17113924']
854,23773375,Influence of different flask systems on tooth displacement and framework misfit in mandibular fixed implant-supported complete dentures.,"PURPOSE


To evaluate the influence of different metallic flask systems for acrylic resin denture processing on tooth displacement and framework misfit of mandibular fixed implant-supported complete dentures.
METHODS


Standard mandibular implant-supported complete dentures in five implants were waxed and randomly assigned to three groups: G1 - conventional flask, G2 - double flask, and G3 - occlusion flask. Framework misfit in all the implants and the linear distances between teeth (I-I - incisor-to-incisor; P-P - premolar-to-premolar; M-M - molar-to-molar; RI-RM - right-incisor-to-right-molar; and LI-LM - left-incisor-to-left-molar) were measured before and after denture processing using an optical microscope. Dentures were processed by hot water curing cycle (9h/74°C). Collected data were analyzed by paired Student's t-test and one-way ANOVA (α=0.05).
RESULTS


All the measured distances presented changes in tooth displacement after denture processing. However, the M-M distance for G1 (p=0.003) and the P-P (p=0.042) and LI-LM (p=0.044) distances for G3 showed statistically significant differences. Differences between the flask systems were not statistically significant. Statistically significant differences in the framework misfit due to denture processing were found for all the implants and groups, with the exception of right median implant for G2 and right distal implant for G3. A comparison of the flask systems found statistically significant differences in which G1 presented an increase in the misfit values and G2 and G3 a decrease.
CONCLUSIONS


Different flask systems did not cause significant changes in tooth displacement. Frameworks misfit values were influenced by the different flask systems. The conventional flask presented an increase in the framework misfit, while the experimental flasks showed a decrease.",2013,"Statistically significant differences in the framework misfit due to denture processing were found for all the implants and groups, with the exception of right median implant for G2 and right distal implant for G3.","['mandibular fixed implant-supported complete dentures', 'Standard mandibular implant-supported complete dentures in five implants', 'acrylic resin denture processing on tooth displacement and framework misfit of mandibular fixed implant-supported complete dentures']","['G1 - conventional flask, G2 - double flask, and G3 - occlusion flask']","['framework misfit due to denture processing', 'tooth displacement', 'Frameworks misfit values', 'misfit values and G2 and G3 a decrease', 'LI-LM', 'tooth displacement and framework misfit']","[{'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0011455', 'cui_str': 'Denture, Complete'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001222', 'cui_str': 'Acrylic Resins'}, {'cui': 'C0011394', 'cui_str': 'Dentures'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}]","[{'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0011394', 'cui_str': 'Dentures'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",5.0,0.0706872,"Statistically significant differences in the framework misfit due to denture processing were found for all the implants and groups, with the exception of right median implant for G2 and right distal implant for G3.","[{'ForeName': 'Conrado Reinoldes', 'Initials': 'CR', 'LastName': 'Caetano', 'Affiliation': 'Piracicaba Dental School, University of Campinas, Piracicaba, SP, Brazil.'}, {'ForeName': 'Rafael Leonardo Xediek', 'Initials': 'RL', 'LastName': 'Consani', 'Affiliation': ''}, {'ForeName': 'Ataís', 'Initials': 'A', 'LastName': 'Bacchi', 'Affiliation': ''}, {'ForeName': 'Américo Bortolazzo', 'Initials': 'AB', 'LastName': 'Correr', 'Affiliation': ''}, {'ForeName': 'Mateus Bertolini Fernandes', 'Initials': 'MB', 'LastName': 'Dos Santos', 'Affiliation': ''}]",Journal of prosthodontic research,['10.1016/j.jpor.2013.04.001']
855,31855906,"Efficacy of Intra-Articular Polynucleotides Associated With Hyaluronic Acid Versus Hyaluronic Acid Alone in the Treatment of Knee Osteoarthritis: A Randomized, Double-Blind, Controlled Clinical Trial.","OBJECTIVE


Pain and range of motion loss are the main clinical features of osteoarthritis (OA). Hyaluronic acid (HA) is one of the infiltrative therapies for OA treatment; however, its effectiveness is a matter of an ongoing debate in clinical practice. Polynucleotides (PNs), a DNA-derived macromolecule with natural origin and trophic activity, were found to favor cell growth and collagen production, in preclinical and clinical studies regarding cartilage regeneration. This study aimed at evaluating whether injection of PNs, in combination with HA [PNs associated with HA (PNHA)], can ameliorate pain and function of knees affected by OA, more than HA alone.
DESIGN


A randomized, double-blind, controlled clinical trial.
PATIENTS


The study enrolled 100 patients, then randomized to receive PNHA or HA alone (3 weekly knee I.A. injections).
INTERVENTIONS AND MAIN OUTCOME MEASURES


Pain reduction, decrease of proinflammatory synovial fluid (SF) factors, and improvement in knee function were evaluated by Knee Society Score and WOMAC scores, after 2, 6, and 12 months and by biochemical and immunoenzymatic analyses of SF at the end of the treatment.
RESULTS


Knee Society Score total score and pain item significantly ameliorated in both groups, showing better results in PNHA- than in the HA-treated group. A significant reduction in the WOMAC score was observed over time for both groups. No significant adverse events were reported in either group.
CONCLUSIONS


These findings suggest that I.A. injection of PNs, in combination with HA, is more effective in improving knee function and pain, in a joint affected by OA, compared with HA alone.",2020,"RESULTS


Knee Society Score total score and pain item significantly ameliorated in both groups, showing better results in PNHA- than in the HA-treated group.","['100 patients', 'Knee Osteoarthritis']","['PNHA or HA alone', 'Hyaluronic Acid Versus Hyaluronic Acid Alone', 'Hyaluronic acid (HA', 'HA [PNs associated with HA (PNHA']","['knee function and pain', 'WOMAC score', 'Knee Society Score and WOMAC scores', 'Pain reduction, decrease of proinflammatory synovial fluid (SF) factors, and improvement in knee function', 'adverse events', 'Knee Society Score total score and pain item']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0039097', 'cui_str': 'Synovia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",100.0,0.245541,"RESULTS


Knee Society Score total score and pain item significantly ameliorated in both groups, showing better results in PNHA- than in the HA-treated group.","[{'ForeName': 'Dante', 'Initials': 'D', 'LastName': 'Dallari', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Sabbioni', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Nicolandrea', 'Initials': 'N', 'LastName': 'Del Piccolo', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Carubbi', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Veronesi', 'Affiliation': 'Laboratory of Preclinical and Surgical Studies, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Torricelli', 'Affiliation': 'Laboratory of Preclinical and Surgical Studies, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Fini', 'Affiliation': 'Laboratory of Preclinical and Surgical Studies, Rizzoli Orthopedic Institute, Bologna, Italy.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000569']
856,31855907,Oral Hypertonic Saline Is Effective in Reversing Acute Mild-to-Moderate Symptomatic Exercise-Associated Hyponatremia.,"OBJECTIVES


To determine whether oral administration of 3% hypertonic saline (HTS) is as efficacious as intravenous (IV) 3% saline in reversing symptoms of mild-to-moderate symptomatic exercise-associated hyponatremia (EAH) in athletes during and after a long-distance triathlon.
DESIGN


Noninferiority, open-label, parallel-group, randomized control trial to IV or oral HTS. We used permuted block randomization with sealed envelopes, containing the word either ""oral"" or ""IV.""
SETTING


Annual long-distance triathlon (3.8-km swim, 180-km bike, and 42-km run) at Mont-Tremblant, Quebec, Canada.
PARTICIPANTS


Twenty race finishers with mild to moderately symptomatic EAH.
INDEPENDENT VARIABLES


Age, sex, race finish time, and 9 clinical symptoms.
MAIN OUTCOME MEASURES


Time from treatment to discharge.
METHODS


We successfully randomized 20 participants to receive either an oral (n = 11) or IV (n = 9) bolus of HTS. We performed venipuncture to measure serum sodium (Na) at presentation to the medical clinic and at time of symptom resolution after the intervention.
RESULTS


The average time from treatment to discharge was 75.8 minutes (SD 29.7) for the IV treatment group and 50.3 minutes (SD 26.8) for the oral treatment group (t test, P = 0.02). Serum Na before and after treatment was not significantly different in both groups. There was no difference on presentation between groups in age, sex, or race finish time, both groups presented with an average of 6 symptoms.
CONCLUSIONS


Oral HTS is effective in reversing symptoms of mild-to-moderate hyponatremia in EAH.",2020,"There was no difference on presentation between groups in age, sex, or race finish time, both groups presented with an average of 6 symptoms.
","['Annual long-distance triathlon (3.8-km swim, 180-km bike, and 42-km run) at Mont-Tremblant, Quebec, Canada', 'Twenty race finishers with mild to moderately symptomatic EAH']","['Oral Hypertonic Saline', 'sealed envelopes, containing the word either ""oral"" or ""IV', 'HTS', 'oral HTS', '3% hypertonic saline (HTS']",['average time'],"[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}]",20.0,0.145485,"There was no difference on presentation between groups in age, sex, or race finish time, both groups presented with an average of 6 symptoms.
","[{'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Bridges', 'Affiliation': 'Department of Emergency Medicine, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Tawfeeq', 'Initials': 'T', 'LastName': 'Altherwi', 'Affiliation': 'EM FRCP Program-McGill University, Montreal, QC, Canada.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Correa', 'Affiliation': 'Department of Mathematics and Statistics, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Hew-Butler', 'Affiliation': 'Oakland University, Rochester, Michigan.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000573']
857,32423038,A Longitudinal Study of a Multicomponent Exercise Intervention with Remote Guidance among Breast Cancer Patients.,"Purpose : Breast cancer patients in treatment suffer from long-term side effects that seriously influence their physical and mental health. The aim of this study was to examine effectiveness of a 12-week multicomponent exercise (ME) with remote guidance intervention on health-related outcomes after one year among breast cancer patients.  Methods : In phases I-III, 60 patients (51.2 ± 7.9 years) with breast cancer (BC) who completed chemotherapy/postoperative radiotherapy within the previous four months to two years were randomly assigned to 1) multicomponent exercise with remote guidance (ME) and 2) usual care (UC). Eligible participants were approached to assess cancer-related quality of life (QOL), muscle strength, cardiorespiratory endurance, and physical activity (PA) barriers after one year.  Results : The results demonstrated that, after one year, the ME group reported higher vitality-related QOL (5.776, 95% confidence interval [CI] 0.987, 10.565, effect size [ES] = 0.360), mental health-related QOL (9.938, 95% CI 4.146, 15.729, ES = 0.512), leg strength and endurance (2.880, CI 1.337, 4.423, ES = 0.557), and strength and endurance of upper extremities (2.745, 95% CI 1.076, 4.415, ES = 0.491) and lower physical activity (PA) hindrance (5.120, 95% CI 1.976, 8.264, ES = 0.486) than the UC group.  Conclusion : The ME group observed significant differences from the UC group in QOL, muscle strength, cardiopulmonary endurance, and PA participation. These findings suggested that the multicomponent exercise intervention with remote guidance produced long-term health benefits for breast cancer patients.",2020,"The results demonstrated that, after one year, the ME group reported higher vitality-related QOL (5.776, 95% confidence interval [CI] 0.987, 10.565, effect size [ES] = 0.360), mental health-related QOL (9.938, 95% CI 4.146, 15.729, ES = 0.512), leg strength and endurance (2.880, CI 1.337, 4.423, ES = 0.557), and strength and endurance of upper extremities (2.745, 95% CI 1.076, 4.415, ES = 0.491) and lower physical activity (PA) hindrance (5.120, 95% CI 1.976, 8.264, ES = 0.486) than the UC group.  ","['breast cancer patients', 'Breast Cancer Patients', '60 patients (51.2 ± 7.9 years) with breast cancer (BC) who completed']","['multicomponent exercise (ME) with remote guidance intervention', 'multicomponent exercise intervention', 'Multicomponent Exercise Intervention', 'chemotherapy', 'multicomponent exercise with remote guidance (ME) and 2) usual care (UC', 'postoperative radiotherapy']","['higher vitality-related QOL', 'leg strength and endurance', 'lower physical activity (PA) hindrance', 'mental health-related QOL', 'QOL, muscle strength, cardiopulmonary endurance, and PA participation', 'strength and endurance of upper extremities', 'cancer-related quality of life (QOL), muscle strength, cardiorespiratory endurance, and physical activity (PA) barriers']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",,0.0333744,"The results demonstrated that, after one year, the ME group reported higher vitality-related QOL (5.776, 95% confidence interval [CI] 0.987, 10.565, effect size [ES] = 0.360), mental health-related QOL (9.938, 95% CI 4.146, 15.729, ES = 0.512), leg strength and endurance (2.880, CI 1.337, 4.423, ES = 0.557), and strength and endurance of upper extremities (2.745, 95% CI 1.076, 4.415, ES = 0.491) and lower physical activity (PA) hindrance (5.120, 95% CI 1.976, 8.264, ES = 0.486) than the UC group.  ","[{'ForeName': 'Xiaosheng', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'Department of Sport and Health, School of Physical Education, Shandong University, Jinan 250061, China.'}, {'ForeName': 'Xiangren', 'Initials': 'X', 'LastName': 'Yi', 'Affiliation': 'Department of Sport and Health, School of Physical Education, Shandong University, Jinan 250061, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Ding', 'Affiliation': 'College of Physical Education, Shandong Normal University, Jinan 250014, China.'}, {'ForeName': 'Zan', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'School of Kinesiology, University of Minnesota, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'McDonough', 'Affiliation': 'School of Kinesiology, University of Minnesota, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Nuo', 'Initials': 'N', 'LastName': 'Yi', 'Affiliation': 'Department of Kinesiology, College of Health Science University of Wisconsin, Milwaukee, WI 53201, USA.'}, {'ForeName': 'Wenzhen', 'Initials': 'W', 'LastName': 'Qiao', 'Affiliation': 'Department of Science and Technology, Shandong Institute of Commerce and Technology, Jinan 250103, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17103425']
858,32422871,The Psychological Effects of a Campus Forest Therapy Program.,"This study aimed to examine the psychological effects of a campus forest therapy program. To evaluate these, pre-test and post-test control group design was employed. A total of 38 participants participated in this study (19 in the campus forest therapy program group, and 19 in control). The Profile of Mood State (POMS) questionnaire and Modified form of the Stress Response Inventory (SRI-MF) were administered to each participant to assess psychological effects. The results of this study revealed that participants in the campus forest therapy program group had significantly positive increases in their mood and stress response compared with those of control group participants. In conclusion, the campus forest therapy program is an efficient strategy to provide psychological health benefits to university students and our study can inform decision-makers on the priority of the campus forest program in societal efforts to promote psychological well-being among university students.",2020,The Profile of Mood State (POMS) questionnaire and Modified form of the Stress Response Inventory (SRI-MF) were administered to each participant to assess psychological effects.,"['university students', '38 participants participated in this study (19 in the campus forest therapy program group, and 19 in control']",[],"['mood and stress response', 'Profile of Mood State (POMS) questionnaire and Modified form of the Stress Response Inventory (SRI-MF']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086312', 'cui_str': 'Forest'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",38.0,0.0197324,The Profile of Mood State (POMS) questionnaire and Modified form of the Stress Response Inventory (SRI-MF) were administered to each participant to assess psychological effects.,"[{'ForeName': 'Jin Gun', 'Initials': 'JG', 'LastName': 'Kim', 'Affiliation': 'Department of Forest Therapy, Chungbuk National University, Cheongju 28644, Korea.'}, {'ForeName': 'Tae Gyu', 'Initials': 'TG', 'LastName': 'Khil', 'Affiliation': 'Department of Forest Therapy, Chungbuk National University, Cheongju 28644, Korea.'}, {'ForeName': 'Youngsuwn', 'Initials': 'Y', 'LastName': 'Lim', 'Affiliation': 'Department of Forest Therapy, Chungbuk National University, Cheongju 28644, Korea.'}, {'ForeName': 'Kyungja', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Department of Forest Therapy, Chungbuk National University, Cheongju 28644, Korea.'}, {'ForeName': 'Minja', 'Initials': 'M', 'LastName': 'Shin', 'Affiliation': 'Department of Forest Therapy, Chungbuk National University, Cheongju 28644, Korea.'}, {'ForeName': 'Won Sop', 'Initials': 'WS', 'LastName': 'Shin', 'Affiliation': 'Department of Forest Sciences, Chungbuk National University, Cheongju 28644, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17103409']
859,31916036,Anti-inflammatory potential of an essential oil-containing mouthwash in elderly subjects enrolled in supportive periodontal therapy: a 6-week randomised controlled clinical trial.,"OBJECTIVES


Essential oils and other plant extracts have evoked interest as sources of natural medicinal products. They have been proven to exert antibacterial, antifungal, antiviral and antioxidant properties, but the mechanism of action has not been fully elucidated.
AIM


This study aims to evaluate the potential of a sage-containing mouthwash to alleviate inflammatory signs of intra-oral mucosa and gingiva in comparison with a water/alcohol-based placebo.
MATERIAL AND METHODS


This study was conducted as a randomised, placebo-controlled, double-blind, parallel design clinical study. Forty-eight dentate subjects were randomly assigned to a test (sage-containing mouthwash) or a placebo group (water/alcohol-based solution). Subjects rinsed once daily for 30 s over a period of 6 weeks. Sulcus Bleeding Index (SBI), Plaque Index (PLI), tooth staining, xerostomia and degree of stomatitis were assessed at baseline and after 6 weeks.
RESULTS


Subjects' mean age was 77.5 ± 7.3 years. SBI was reduced from 1.3 ± 0.9 to 0.8 ± 0.7 (test, p = 0.0029) and 1.4 ± 0.9 to 1.1 ± 0.7 (placebo, p = 0.0105). Similarly, PLI was reduced from 1.2 ± 0.5 to 1.0 ± 0.3 (test, p = 0.0080) and 1.3 ± 0.4 to 1.1 ± 0.6 (placebo, p = 0.0087); no between-group differences were found (p > 0.05). Stomatitis, xerostomia and tooth staining revealed no change after 6 weeks.
CONCLUSION


The irrigation with a sage-containing mouthwash did not result in a superior beneficial effect on inflammatory parameters and plaque indices compared with the placebo. The expected contribution of the plant extracts to their potential impact on oral health may need further investigation.
CLINICAL RELEVANCE


The proposed mouthwash might be suitable for patients with inflammatory signs of the gingiva who prefer natural remedies.",2020,The irrigation with a sage-containing mouthwash did not result in a superior beneficial effect on inflammatory parameters and plaque indices compared with the placebo.,"['elderly subjects enrolled in supportive periodontal therapy', 'Forty-eight dentate subjects', ""Subjects' mean age was 77.5\u2009±\u20097.3\xa0years"", 'patients with inflammatory signs of the gingiva who prefer natural remedies']","['sage-containing mouthwash', 'placebo', 'essential oil-containing mouthwash', 'water/alcohol-based placebo', 'placebo group (water/alcohol-based solution']","['SBI', 'PLI', 'Sulcus Bleeding Index (SBI), Plaque Index (PLI), tooth staining, xerostomia and degree of stomatitis', 'inflammatory parameters and plaque indices', 'Stomatitis, xerostomia and tooth staining']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0017562', 'cui_str': 'Gums'}, {'cui': 'C3543840', 'cui_str': 'Preferred'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}]","[{'cui': 'C1122976', 'cui_str': 'Sage (substance)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0028910', 'cui_str': 'Oils, Essential'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.386102,The irrigation with a sage-containing mouthwash did not result in a superior beneficial effect on inflammatory parameters and plaque indices compared with the placebo.,"[{'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Jünger', 'Affiliation': 'Division of Gerodontology, Department of Reconstructive Dentistry and Gerodontology, School of Dental Medicine, University of Bern, Freiburgstrasse 7, 3010, Bern, Switzerland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Jaun-Ventrice', 'Affiliation': 'Division of Gerodontology, Department of Reconstructive Dentistry and Gerodontology, School of Dental Medicine, University of Bern, Freiburgstrasse 7, 3010, Bern, Switzerland.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Guldener', 'Affiliation': 'Department of Periodontology, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Christoph A', 'Initials': 'CA', 'LastName': 'Ramseier', 'Affiliation': 'Department of Periodontology, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Reissmann', 'Affiliation': 'Department of Prosthetic Dentistry, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schimmel', 'Affiliation': 'Division of Gerodontology, Department of Reconstructive Dentistry and Gerodontology, School of Dental Medicine, University of Bern, Freiburgstrasse 7, 3010, Bern, Switzerland. martin.schimmel@zmk.unibe.ch.'}]",Clinical oral investigations,['10.1007/s00784-019-03194-3']
860,32060506,Impact of a 4-hour Introductory eFAST Training Intervention Among Ultrasound-Naïve U.S. Military Medics.,"INTRODUCTION


Advances in the portability of ultrasound have allowed it to be increasingly employed at the point of care in austere settings. Battlefield constraints often limit the availability of medical officers throughout the operational environment, leading to increased interest in whether highly portable ultrasound devices can be employed by military medics to enhance their provision of combat casualty care. Data evaluating optimal training for effective medic employment of ultrasound is limited however. This prospective observational cohort study's primary objective was to assess the impact of a 4-hour introductory training intervention on ultrasound-naïve military medic participants' knowledge/performance of the eFAST application.
MATERIALS AND METHODS


Conventional U.S. Army Medics, all naïve to ultrasound, were recruited from across JBLM. Volunteer participants underwent baseline eFAST knowledge assessment via a 50-question multiple-choice exam. Participants were then randomized to receive either conventional, expert-led classroom didactic training or didactic training via an online, asynchronously available platform. All participants then underwent expert-led, small group hands-on training and practice. Participants' eFAST performance was then assessed with both live and phantom models, followed by a post-course knowledge exam. Concurrently, emergency medicine (EM) resident physician volunteers, serving as standard criterion for trained personnel, underwent the same OSCE assessments, followed by a written exam to assess their baseline eFAST knowledge. Primary outcome measures included (1) post-course knowledge improvement, (2) eFAST exam technical adequacy, and (3) eFAST exam OSCE score. Secondary outcome measures were time to exam completion and diagnostic accuracy rate for hemoperitoneum and hemopericardium. These outcome measures were then compared across medic cohorts and to those of the EM resident physician cohort.
RESULTS


A total of 34 medics completed the study. After 4 hours of ultrasound training, overall eFAST knowledge among the 34 medics improved from a baseline mean of 27% on the pretest to 83% post-test. For eFAST exam performance, the medics scored an average of 20.8 out of a maximum of 22 points on the OSCE. There were no statistically significant differences between the medics who received asynchronous learning versus traditional classroom-based learning, and the medics demonstrated comparable performance to previously trained EM resident physicians.
CONCLUSIONS


A 4-hour introductory eFAST training intervention can effectively train conventional military medics to perform the eFAST exam. Online, asynchronously available platforms may effectively mitigate some of the resource requirement burden associated with point-of-care ultrasound training. Future studies evaluating medic eFAST performance on real-world battlefield trauma patients are needed. Skill and knowledge retention must also be assessed for this degradable skill to determine frequency of refresher training when not regularly performed.",2020,"There were no statistically significant differences between the medics who received asynchronous learning versus traditional classroom-based learning, and the medics demonstrated comparable performance to previously trained EM resident physicians.
","['A total of 34 medics completed the study', 'Volunteer participants underwent baseline eFAST knowledge assessment via a 50-question multiple-choice exam', 'Conventional U.S. Army Medics, all naïve to ultrasound, were recruited from across JBLM']","['4-hour Introductory eFAST Training Intervention', 'asynchronous learning', 'conventional, expert-led classroom didactic training or didactic training via an online, asynchronously available platform', '4-hour introductory training intervention', 'introductory eFAST training intervention']","['time to exam completion and diagnostic accuracy rate for hemoperitoneum and hemopericardium', 'overall eFAST knowledge', '1) post-course knowledge improvement, (2) eFAST exam technical adequacy, and (3) eFAST exam OSCE score']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C1292426', 'cui_str': '4 hours (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439581', 'cui_str': 'Asynchronous (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0019065', 'cui_str': 'Hemoperitoneum'}, {'cui': 'C0019064', 'cui_str': 'Hemopericardium'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C4704780', 'cui_str': 'Extended Focused Assessment with Sonography for Trauma'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0579016,"There were no statistically significant differences between the medics who received asynchronous learning versus traditional classroom-based learning, and the medics demonstrated comparable performance to previously trained EM resident physicians.
","[{'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Monti', 'Affiliation': 'Henry M. Jackson Foundation for the Advancement of Military Medicine, Madigan Army Medical Center, 9040 Jackson Avenue, Joint Base Lewis-McChord, Washington 98431.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Perreault', 'Affiliation': 'Department of Emergency Medicine, Madigan Army Medical Center, 9040 Jackson Avenue, Joint Base Lewis-McChord, Washington 98431.'}]",Military medicine,['10.1093/milmed/usaa014']
861,32427415,"Authors' reply re: Antenatal magnesium sulphate for the prevention of cerebral palsy in infants born preterm: a double-blind, randomised, placebo-controlled, multi-centre trial: Time range for treatment with magnesium sulphate.",,2020,,"['born preterm', 'cerebral palsy in infants']","['magnesium sulphate', 'Antenatal magnesium sulphate', 'placebo']",[],"[{'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.770591,,"[{'ForeName': 'Hanne Trap', 'Initials': 'HT', 'LastName': 'Wolf', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Brok', 'Affiliation': 'Department of Paediatric and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Tine Brink', 'Initials': 'TB', 'LastName': 'Henriksen', 'Affiliation': 'Perinatal Epidemiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Hanne Kristine', 'Initials': 'HK', 'LastName': 'Hegaard', 'Affiliation': 'Department of Obstetrics and Gynaecology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Gorm', 'Initials': 'G', 'LastName': 'Greisen', 'Affiliation': 'Department of Neonatology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Weber', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Pryds', 'Affiliation': 'Department of Paediatrics, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Jannie Dalby', 'Initials': 'JD', 'LastName': 'Salvig', 'Affiliation': 'Department of Obstetrics and Gynaecology, Skejby University Hospital, Skejby, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Hedegaard', 'Affiliation': 'Department of Obstetrics, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Pinborg', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Lene Drasbek', 'Initials': 'LD', 'LastName': 'Huusom', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre Hospital, Hvidovre, Denmark.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16267']
862,31403675,Treating Parents for Tobacco Use in the Pediatric Setting: The Clinical Effort Against Secondhand Smoke Exposure Cluster Randomized Clinical Trial.,"Importance


Despite the availability of free and effective treatment, few pediatric practices identify and treat parental tobacco use.
Objective


To determine if the Clinical Effort Against Secondhand Smoke Exposure (CEASE) intervention can be implemented and sustained in pediatric practices and test whether implementing CEASE led to changes in practice-level prevalence of smoking among parents over 2 years.
Design, Setting, and Participants


This cluster randomized clinical trial was conducted from April 2015 to October 2017. Ten pediatric practices in 5 states were randomized to either implement the CEASE protocol or maintain usual care (as a control group). All parents who screened positive for tobacco use by exit survey after their child's clinical visit 2 weeks (from April to October 2015) and 2 years after intervention implementation (April to October 2017) were eligible to participate. Data analysis occurred from January 2018 to March 2019.
Interventions


The CEASE intervention is a practice-change intervention designed to facilitate both routine screening in pediatric settings of families for tobacco use and delivery of tobacco cessation treatment to individuals in screened households who use tobacco.
Main Outcomes and Measures


The primary outcome was delivery of meaningful tobacco treatment, defined as the prescription of nicotine replacement therapy or quit line enrollment. Furthermore, changes in practice-level smoking prevalence and cotinine-confirmed quit rates over the 2 years of intervention implementation were assessed.
Results


Of the 8184 parents screened after their child's visit 2 weeks after intervention implementation, 961 (27.1%) were identified as currently smoking in intervention practices; 1103 parents (23.9%) were currently smoking in control practices. Among the 822 and 701 eligible parents who completed the survey in intervention and control practices, respectively 364 in the intervention practices (44.3%) vs 1 in a control practice (0.1%) received meaningful treatment at that visit (risk difference, 44.0% [95% CI, 9.8%-84.8%]). Two years later, of the 9794 parents screened, 1261 (24.4%) in intervention practices and 1149 (25.0%) in control practices were identified as currently smoking. Among the 804 and 727 eligible parents completing the survey in intervention and control practices, respectively, 113 in the intervention practices (14.1%) vs 2 in the control practices (0.3%) received meaningful treatment at that visit (risk difference, 12.8% [95% CI, 3.3%-37.8%]). Change in smoking prevalence over the 2 years of intervention implementation favored the intervention (-2.7% vs 1.1%; difference -3.7% [95% CI, -6.3% to -1.2%]), as did the cotinine-confirmed quit rate (2.4% vs -3.2%; difference, 5.5% [95% CI, 1.4%-9.6%]).
Conclusions and Relevance


In this trial, integrating screening and treatment for parental tobacco use in pediatric practices showed both immediate and long-term increases in treatment delivery, a decline in practice-level parental smoking prevalence, and an increase in cotinine-confirmed cessation, compared with usual care.
Trial Registration


ClinicalTrials.gov identifier: NCT01882348.",2019,"The CEASE intervention is a practice-change intervention designed to facilitate both routine screening in pediatric settings of families for tobacco use and delivery of tobacco cessation treatment to individuals in screened households who use tobacco.
","['Treating Parents for Tobacco Use in the Pediatric Setting', '822 and 701 eligible parents who completed the survey in intervention and control practices, respectively 364 in the intervention practices (44.3%) vs 1 in a control practice (0.1', ""8184 parents screened after their child's visit 2 weeks after intervention implementation, 961 (27.1%) were identified as currently smoking in intervention practices; 1103 parents (23.9%) were currently smoking in control practices"", 'Ten pediatric practices in 5 states', ""All parents who screened positive for tobacco use by exit survey after their child's clinical visit 2 weeks (from April to October 2015) and 2 years after intervention implementation (April to October 2017) were eligible to participate"", 'Two years later, of the 9794 parents screened, 1261 (24.4%) in intervention practices and 1149 (25.0%) in control practices were identified as currently smoking']","['tobacco cessation treatment', 'Secondhand Smoke Exposure (CEASE) intervention', 'CEASE protocol or maintain usual care']","['practice-level smoking prevalence and cotinine-confirmed quit rates', 'delivery of meaningful tobacco treatment, defined as the prescription of nicotine replacement therapy or quit line enrollment', 'smoking prevalence', 'cotinine-confirmed quit rate']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0337094', 'cui_str': 'Exit (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}]","[{'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0037370', 'cui_str': 'Smoking, Passive'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]",1103.0,0.094182,"The CEASE intervention is a practice-change intervention designed to facilitate both routine screening in pediatric settings of families for tobacco use and delivery of tobacco cessation treatment to individuals in screened households who use tobacco.
","[{'ForeName': 'Emara', 'Initials': 'E', 'LastName': 'Nabi-Burza', 'Affiliation': 'Division of General Academic Pediatrics, Massachusetts General Hospital for Children, Boston.'}, {'ForeName': 'Jeremy E', 'Initials': 'JE', 'LastName': 'Drehmer', 'Affiliation': 'Division of General Academic Pediatrics, Massachusetts General Hospital for Children, Boston.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Hipple Walters', 'Affiliation': 'Division of General Academic Pediatrics, Massachusetts General Hospital for Children, Boston.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Rigotti', 'Affiliation': 'Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Ossip', 'Affiliation': 'Department of Public Health Sciences, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Levy', 'Affiliation': 'Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Klein', 'Affiliation': 'American Academy of Pediatrics, Julius B. Richmond Center of Excellence, Itasca, Illinois.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Regan', 'Affiliation': 'Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Gorzkowski', 'Affiliation': 'American Academy of Pediatrics, Julius B. Richmond Center of Excellence, Itasca, Illinois.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Winickoff', 'Affiliation': 'Division of General Academic Pediatrics, Massachusetts General Hospital for Children, Boston.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2019.2639']
863,22364141,A switch in therapy to a reverse transcriptase inhibitor sparing combination of lopinavir/ritonavir and raltegravir in virologically suppressed HIV-infected patients: a pilot randomized trial to assess efficacy and safety profile: the KITE study.,"A nucleoside reverse transcriptase inhibitor (NRTI) backbone is a recommended component of standard highly active antiretroviral therapy (sHAART). However, long-term NRTI exposure can be limited by toxicities. NRTI class-sparing alternatives are warranted in select patient populations. This is a 48-week single-center, open-label pilot study in which 60 HIV-infected adults with plasma HIV-1 RNA (<50 copies/ml) on sHAART were randomized (2:1) to lopinavir/ritonavir (LPV/r) 400/100 mg BID+raltegravir (RAL) 400 mg BID switch (LPV-r/RAL arm) or to continue on sHAART. The primary endpoint was the proportion of subjects with HIV-RNA<50 copies/ml at week 48. Secondary efficacy and immunologic and safety endpoints were evaluated. Demographics and baseline lipid profile were similar across arms. Mean entry CD4 T cell count was 493 cells/mm(3). At week 48, 92% [95% confidence interval (CI): 83-100%] of the LPV-r/RAL arm and 88% (95% CI: 75-100%) of the sHAART arm had HIV-RNA<50 copies/ml (p=0.70). Lipid profile (mean ± SEM, mg/dl, LPV-r/RAL vs. sHAART) at week 24 was total-cholesterol 194 ± 5 vs. 176 ± 9 (p=0.07), triglycerides 234 ± 30 vs. 133 ± 27 (p=0.003), and LDL-cholesterol 121 ± 6 vs. 110 ± 8 (p=0.27). There were no serious adverse events (AEs) in either arm. Regimen change occurred in three LPV-r/RAL subjects (n=1, due to LPV-r/RAL-related AEs) vs. 0 in sHAART. There were no differences between arms in bone mineral density, total body fat composition, creatinine clearance, or CD4 T cell counts at week 48. In virologically suppressed patients on HAART, switching therapy to the NRTI-sparing LPV-r/RAL combination produced similar sustained virologic suppression and immunologic profile as sHAART. AEs were comparable between arms, but the LPV-r/RAL arm experienced higher triglyceridemia.",2012,"There were no differences between arms in bone mineral density, total body fat composition, creatinine clearance, or CD4 T cell counts at week 48.","['virologically suppressed HIV-infected patients', '60 HIV-infected adults with plasma HIV-1 RNA (<50 copies/ml) on sHAART']","['lopinavir/ritonavir (LPV/r) 400/100', 'mg BID+raltegravir (RAL', 'lopinavir/ritonavir and raltegravir', 'nucleoside reverse transcriptase inhibitor (NRTI) backbone']","['bone mineral density, total body fat composition, creatinine clearance, or CD4 T cell counts', 'triglyceridemia', 'Demographics and baseline lipid profile', 'Lipid profile', 'proportion of subjects with HIV-RNA<50 copies/ml', 'Mean entry CD4 T cell count']","[{'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir / Ritonavir'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C0028621', 'cui_str': 'Nucleosides'}, {'cui': 'C4521921', 'cui_str': 'Reverse transcriptase inhibitor'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0424677', 'cui_str': 'Total body fat (observable entity)'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.206431,"There were no differences between arms in bone mineral density, total body fat composition, creatinine clearance, or CD4 T cell counts at week 48.","[{'ForeName': 'Ighovwerha', 'Initials': 'I', 'LastName': 'Ofotokun', 'Affiliation': 'Emory University School of Medicine, Department of Medicine, Division of Infectious Diseases, Atlanta, Georgia 30303, USA. iofotok@emory.edu'}, {'ForeName': 'Anandi N', 'Initials': 'AN', 'LastName': 'Sheth', 'Affiliation': ''}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Sanford', 'Affiliation': ''}, {'ForeName': 'Kirk A', 'Initials': 'KA', 'LastName': 'Easley', 'Affiliation': ''}, {'ForeName': 'Neeta', 'Initials': 'N', 'LastName': 'Shenvi', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'White', 'Affiliation': ''}, {'ForeName': 'Molly E', 'Initials': 'ME', 'LastName': 'Eaton', 'Affiliation': ''}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Del Rio', 'Affiliation': ''}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Lennox', 'Affiliation': ''}]",AIDS research and human retroviruses,[]
864,32423126,Effects of Combined Resistance and Power Training on Cognitive Function in Older Women: A Randomized Controlled Trial.,"The present study compared the effects of traditional resistance training (TRT) and combined power training (PT) and TRT (PTRT) on cognitive parameters and serum brain-derived neurotrophic factor (BDNF) levels in non-demented, well-functioning, community-dwelling older women. Forty-five older women were randomized into one of three experimental groups: TRT, PTRT, and control group (CG). Cognitive tests explored global cognitive function, short-term memory, and dual-task performance. Serum BDNF levels were assessed at baseline and after the intervention. Exercise sessions were performed twice a week over 22 weeks. In TRT, exercise sessions were based on three sets of 8-10 repetitions at ""difficult"" intensity. In PTRT, the first session was based on PT (three sets of 8-10 repetitions at ""moderate"" intensity), while the second session was similar to the TRT. Our analyses indicated that overall cognitive function, short-term memory, and dual-task performance were similarly improved after TRT and PTRT. Serum BDNF concentrations were not altered by any training protocol. In conclusion, the two RT programs tested in the present trial improved global cognitive function, short-term memory and dual task performance in non-demented, well-functioning, community-dwelling older women. In addition, our findings suggest that mechanisms other than BDNF may be associated with such improvements.",2020,"Our analyses indicated that overall cognitive function, short-term memory, and dual-task performance were similarly improved after TRT and PTRT.","['Forty-five older women', 'Older Women', 'non-demented, well-functioning, community-dwelling older women']","['traditional resistance training (TRT) and combined power training (PT) and TRT (PTRT', 'TRT, PTRT, and control group (CG', 'Combined Resistance and Power Training']","['cognitive parameters and serum brain-derived neurotrophic factor (BDNF) levels', 'global cognitive function, short-term memory, and dual-task performance', 'Serum BDNF concentrations', 'global cognitive function, short-term memory and dual task performance', 'Serum BDNF levels', 'Cognitive Function', 'overall cognitive function, short-term memory, and dual-task performance']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0860630', 'cui_str': 'Demented'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",45.0,0.0217528,"Our analyses indicated that overall cognitive function, short-term memory, and dual-task performance were similarly improved after TRT and PTRT.","[{'ForeName': 'Hélio José', 'Initials': 'HJ', 'LastName': 'Coelho-Júnior', 'Affiliation': 'Applied Kinesiology Laboratory-AKL, School of Physical Education, University of Campinas, Campinas, SP 13083-851, Brazil.'}, {'ForeName': 'Ivan de Oliveira', 'Initials': 'IO', 'LastName': 'Gonçalves', 'Affiliation': 'Center of Health Sciences, University of Mogi das Cruzes, Mogi das Cruzes 08780-911, Brazil.'}, {'ForeName': 'Ricardo Aurélio Carvalho', 'Initials': 'RAC', 'LastName': 'Sampaio', 'Affiliation': 'Applied Kinesiology Laboratory-AKL, School of Physical Education, University of Campinas, Campinas, SP 13083-851, Brazil.'}, {'ForeName': 'Priscila Yukari Sewo', 'Initials': 'PYS', 'LastName': 'Sampaio', 'Affiliation': 'Applied Kinesiology Laboratory-AKL, School of Physical Education, University of Campinas, Campinas, SP 13083-851, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Lusa Cadore', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Federal University of Rio Grande do Sul, Porto Alegre, RS 90040-060, Brazil.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Calvani', 'Affiliation': 'Institute of Internal Medicine and Geriatrics, Università Cattolica del Sacro Cuore, 00168 Rome, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Picca', 'Affiliation': 'Institute of Internal Medicine and Geriatrics, Università Cattolica del Sacro Cuore, 00168 Rome, Italy.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), Navarra Institute for Health Research (IdiSNA), 31008 Pamplona, Spain.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Marzetti', 'Affiliation': 'Fondazione Policlinico Universitario ""Agostino Gemelli"" IRCCS, 00168 Rome, Italy.'}, {'ForeName': 'Marco Carlos', 'Initials': 'MC', 'LastName': 'Uchida', 'Affiliation': 'Applied Kinesiology Laboratory-AKL, School of Physical Education, University of Campinas, Campinas, SP 13083-851, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph17103435']
865,32423151,Effects of Different Ankle Supports on the Single-Leg Lateral Drop Landing Following Muscle Fatigue in Athletes with Functional Ankle Instability.,"BACKGROUND


Ankle support has been utilized for athletes with functional ankle instability (FAI), however, its effect on the landing performance during muscle fatigue is not well understood. This study aimed to examine the effects of ankle supports (ankle brace vs. Kinesio tape) on athletes with FAI following fatigued single-leg landing.
METHODS


Thirty-three young FAI athletes (CAIT scores < 24) were randomly allocated to control (Cn), ankle brace (AB) and Kinesio tape (KT) groups. All athletes performed single-leg lateral drop landings following ankle fatigue protocol. The fatigue-induced changes in kinetic parameters were measured among three groups.
RESULTS


A significant increase in peak vertical ground reaction force (vGRF) was found in the AB group (0.12% body weight (BW)) compared to that of the KT (0.02% BW) and Cn (median = 0.01% BW) groups. Significant decrease in both COP medial-lateral (ML) and anterior-posterior (AP) ranges were also found in the KT group (median = -0.15% foot width (FW) & median = -0.28% foot length (FL)) than those of the Cn group (median = 0.67% FW& median = 0.88% FL).
CONCLUSIONS


Ankle braces might hamper the ability to absorb the impact force during landing. On the other hand, Kinesio tape might be beneficial for the postural control during landing.",2020,A significant increase in peak vertical ground reaction force (vGRF) was found in the AB group (0.12% body weight (BW)) compared to that of the KT (0.02% BW) and Cn (median = 0.01% BW) groups.,"['Athletes with Functional Ankle Instability', 'athletes with FAI following fatigued single-leg landing', 'Thirty-three young FAI athletes (CAIT scores < 24', 'athletes with functional ankle instability (FAI']","['Single-Leg Lateral Drop Landing', 'ankle supports (ankle brace vs. Kinesio tape', 'control (Cn), ankle brace (AB) and Kinesio tape (KT']","['peak vertical ground reaction force (vGRF', 'COP medial-lateral (ML) and anterior-posterior (AP) ranges']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0277851', 'cui_str': 'Ankle instability'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",33.0,0.0268298,A significant increase in peak vertical ground reaction force (vGRF) was found in the AB group (0.12% body weight (BW)) compared to that of the KT (0.02% BW) and Cn (median = 0.01% BW) groups.,"[{'ForeName': 'Cheng-Chieh', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'Department of Physical Therapy, Tzu Hui Institute of Technology, Pingtung 926001, Taiwan.'}, {'ForeName': 'Shing-Jye', 'Initials': 'SJ', 'LastName': 'Chen', 'Affiliation': 'Department of Product Design, College of Design, Tainan University of Technology, Tainan 71002, Taiwan.'}, {'ForeName': 'Wan-Chin', 'Initials': 'WC', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, College of Medicine, National Cheng Kung University, Tainan 70101, Taiwan.'}, {'ForeName': 'Cheng-Feng', 'Initials': 'CF', 'LastName': 'Lin', 'Affiliation': 'Department of Physical Therapy, College of Medicine, National Cheng Kung University, Tainan 70101, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17103438']
866,21357906,Treatment of chronic rhinosinusitis with nasal polyposis with oral steroids followed by topical steroids: a randomized trial.,"BACKGROUND


Chronic rhinosinusitis (CRS) with nasal polyposis is common. The long-term efficacy and safety of approaches to medical management are not well-known.
OBJECTIVE


To evaluate the efficacy and safety of a 2-week regimen of oral steroid therapy followed by 26 weeks of sequential topical steroid maintenance therapy.
DESIGN


Parallel randomized trial with computer-generated block randomization and central allocation. Patients and investigators were blinded to group assignment. (ClinicalTrials.gov registration number: NCT00788749)
SETTING


A specialty rhinology clinic in Tayside, Scotland.
PATIENTS


60 adults with CRS and moderate-sized or larger nasal polyps who were referred by their primary physicians for specialty care.
INTERVENTIONS


Patients were randomly assigned in a 1:1 ratio to receive oral prednisolone, 25 mg/d, or placebo for 2 weeks, followed in both groups by fluticasone propionate nasal drops, 400 µg twice daily, for 8 weeks and then fluticasone propionate nasal spray, 200 µg twice daily, for 18 weeks.
MEASUREMENTS


Polyp grading (primary outcome), hyposmia score, quality of life, symptoms, nasal patency, adrenal function, and bone turnover.
RESULTS


The mean decrease in polyp grade from baseline to 2 weeks was 2.1 units (SD, 1.1) in the prednisolone group and 0.1 unit (SD, 1.0) in the placebo group (mean difference between groups, -1.8 units [95% CI, -2.4 to -1.2 units]; P < 0.001). The difference between groups was -1.08 units (CI, -1.74 to -0.42 unit; P = 0.001) at 10 weeks and -0.8 unit (CI, -1.8 to 0.2 unit; P = 0.11) at 28 weeks. The mean decrease in hyposmia score from baseline to 2 weeks was 31.12 mm (SD, 30.1) in the prednisolone group and 1.41 mm (SD, 30.6) in the placebo group (mean difference between groups, -28.33 mm [CI, -42.71 to -13.96 mm]; P = 0.002). The difference between groups was -16.06 mm (CI, -30.99 to -1.13 mm; P = 0.03) at 10 weeks and -12.13 mm (CI, -30.55 to 6.29 mm; P = 0.19) at 28 weeks. Prednisolone therapy resulted in transient suppression of adrenal function and increase in bone turnover after 2 weeks, with a return to baseline at 10 and 28 weeks.
LIMITATIONS


Patients were referred from primary care to a single-center rhinology clinic, which limits the generalizability of results. Serial measurements of surrogates of nasal inflammation (such as nitric oxide or cytokine levels) were not performed.
CONCLUSION


Initial oral steroid therapy followed by topical steroid therapy seems to be more effective over 6 months than topical steroid therapy alone in decreasing polyp size and improving olfaction in patients referred for specialty care of CRS with at least moderate nasal polyposis.
PRIMARY FUNDING SOURCE


Chief Scientist Office, Scotland; National Health Service Tayside Small Grants Scheme; and an Anonymous Trust grant from University of Dundee.",2011,"The difference between groups was -16.06 mm (CI, -30.99 to -1.13 mm; P = 0.03) at 10 weeks and -12.13 mm (CI, -30.55 to 6.29 mm; P = 0.19) at 28 weeks.","['A specialty rhinology clinic in Tayside, Scotland', 'Patients were referred from primary care to a single-center rhinology clinic', 'Chronic rhinosinusitis (CRS) with nasal polyposis', 'chronic rhinosinusitis with nasal polyposis with', '60 adults with CRS and moderate-sized or larger nasal polyps who were referred by their primary physicians for specialty care', 'patients referred for specialty care of CRS with at least moderate nasal polyposis']","['placebo', 'oral prednisolone', 'fluticasone propionate nasal spray', 'fluticasone propionate nasal drops', 'oral steroids', 'prednisolone', 'oral steroid therapy', 'topical steroids', 'Prednisolone therapy']","['transient suppression of adrenal function', 'Polyp grading (primary outcome), hyposmia score, quality of life, symptoms, nasal patency, adrenal function, and bone turnover', 'efficacy and safety', 'mean decrease in polyp grade', 'bone turnover', 'polyp size and improving olfaction', 'Serial measurements of surrogates of nasal inflammation (such as nitric oxide or cytokine levels', 'hyposmia score']","[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0454914', 'cui_str': 'Tayside (geographic location)'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0149516', 'cui_str': 'Chronic sinusitis (disorder)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0334108', 'cui_str': 'Multiple polyps (morphologic abnormality)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0027430', 'cui_str': 'Nasal Polyps'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C0991524', 'cui_str': 'Nasal drops'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0574135', 'cui_str': 'Oral steroid therapy (procedure)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2364082', 'cui_str': 'Sense of smell impaired (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C1299212', 'cui_str': 'Polyp size'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0037361', 'cui_str': 'Sense of Smell'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C2718128', 'cui_str': 'Nasal inflammation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",60.0,0.360044,"The difference between groups was -16.06 mm (CI, -30.99 to -1.13 mm; P = 0.03) at 10 weeks and -12.13 mm (CI, -30.55 to 6.29 mm; P = 0.19) at 28 weeks.","[{'ForeName': 'Sriram', 'Initials': 'S', 'LastName': 'Vaidyanathan', 'Affiliation': 'Ninewells Hospital, University of Dundee, United Kingdom.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Barnes', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Williamson', 'Affiliation': ''}, {'ForeName': 'Pippa', 'Initials': 'P', 'LastName': 'Hopkinson', 'Affiliation': ''}, {'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Donnan', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lipworth', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/0003-4819-154-5-201103010-00003']
867,22318468,N-acetylcysteine reduces oxidative stress in sickle cell patients.,"Oxidative stress is of importance in the pathophysiology of sickle cell disease (SCD). In this open label randomized pilot study the effects of oral N-acetylcysteine (NAC) on phosphatidylserine (PS) expression as marker of cellular oxidative damage (primary end point), and markers of hemolysis, coagulation and endothelial activation and NAC tolerability (secondary end points) were studied. Eleven consecutive patients (ten homozygous [HbSS] sickle cell patients, one HbSβ(0)-thalassemia patient) were randomly assigned to treatment with either 1,200 or 2,400 mg NAC daily during 6 weeks. The data indicate an increment in whole blood glutathione levels and a decrease in erythrocyte outer membrane phosphatidylserine exposure, plasma levels of advanced glycation end-products (AGEs) and cell-free hemoglobin after 6 weeks of NAC treatment in both dose groups. One patient did not tolerate the 2,400 mg dose and continued with the 1,200 mg dose. During the study period, none of the patients experienced painful crises or other significant SCD or NAC related complications. These data indicate that N-acetylcysteine treatment of sickle cell patients may reduce SCD related oxidative stress.",2012,"During the study period, none of the patients experienced painful crises or other significant SCD or NAC related complications.","['Eleven consecutive patients (ten homozygous [HbSS] sickle cell patients, one HbSβ(0)-thalassemia patient', 'sickle cell patients']","['N-acetylcysteine', 'oral N-acetylcysteine (NAC']","['painful crises', 'whole blood glutathione levels', 'oxidative stress', 'phosphatidylserine (PS) expression as marker of cellular oxidative damage (primary end point), and markers of hemolysis, coagulation and endothelial activation and NAC tolerability', 'erythrocyte outer membrane phosphatidylserine exposure, plasma levels of advanced glycation end-products (AGEs) and cell-free hemoglobin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0221283', 'cui_str': 'Drepanocyte (cell)'}, {'cui': 'C0039730', 'cui_str': 'Thalassemia'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231224', 'cui_str': 'Crisis (finding)'}, {'cui': 'C0370231', 'cui_str': 'Whole blood (substance)'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0031623', 'cui_str': 'Phosphatidyl Serines'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C2937287', 'cui_str': 'Hemolysis (observable entity)'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation Endproducts'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C3854324', 'cui_str': 'Free hemoglobin'}]",11.0,0.0225314,"During the study period, none of the patients experienced painful crises or other significant SCD or NAC related complications.","[{'ForeName': 'Erfan', 'Initials': 'E', 'LastName': 'Nur', 'Affiliation': 'Department of Internal Medicine, Slotervaart Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Dees P', 'Initials': 'DP', 'LastName': 'Brandjes', 'Affiliation': ''}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Teerlink', 'Affiliation': ''}, {'ForeName': 'Hans-Martin', 'Initials': 'HM', 'LastName': 'Otten', 'Affiliation': ''}, {'ForeName': 'Ronald P J', 'Initials': 'RP', 'LastName': 'Oude Elferink', 'Affiliation': ''}, {'ForeName': 'Frits', 'Initials': 'F', 'LastName': 'Muskiet', 'Affiliation': ''}, {'ForeName': 'Ludo M', 'Initials': 'LM', 'LastName': 'Evers', 'Affiliation': ''}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'ten Cate', 'Affiliation': ''}, {'ForeName': 'Bart J', 'Initials': 'BJ', 'LastName': 'Biemond', 'Affiliation': ''}, {'ForeName': 'Ashley J', 'Initials': 'AJ', 'LastName': 'Duits', 'Affiliation': ''}, {'ForeName': 'John-John B', 'Initials': 'JJ', 'LastName': 'Schnog', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of hematology,['10.1007/s00277-011-1404-z']
868,21905250,Identifying common trajectories of joint space narrowing over two years in knee osteoarthritis.,"OBJECTIVE


Little is known about the natural history of knee osteoarthritis (OA). We sought to identify common patterns of joint space narrowing (JSN) in well-characterized knee OA patients in the placebo arm of a 2-year international study.
METHODS


We performed secondary data analyses of 622 adults ages 39-80 years in North America (n = 310) and Europe (n = 312) with symptomatic knee OA. Fluoroscopically positioned semiflexed anteroposterior radiographs were obtained at 0, 12, and 24 months. Group-based trajectory modeling was used to identify distinctive groups of individuals with similar trajectories of JSN, taking into account sex, age, and body mass index.
RESULTS


Seven groups were identified. Four exhibited joint space width (JSW) stability over 2 years representing the most common trajectory (71%), which was unrelated to initial JSW. Atypical courses included slow, rapid, and moderate progressors; most had significant JSN at study entry. Slow progressors (20%) had a mean JSN of 0.2 mm over 2 years. Only 2% of the sample demonstrated rapid JSN (2.1 mm), while 7% had JSN of 0.7 mm. Rapid progressors tended to be men, while slow and moderate progressors were older and heavier.
CONCLUSION


Most (70%) people with OA demonstrated no significant JSN over 2 years; 20% showed slow progression, 7% had moderate, and 2% had rapid JSN. Progressors tended to have less JSW at study entry and were older and heavier; rapid progressors were more likely to be men. Understanding common patterns of the course of knee OA may offer new opportunities to target those at greatest risk of disability.",2011,"JSW) stability over 2 years representing the most common trajectory (71%), which was unrelated to initial JSW.",['622 adults ages 39-80 years in North America (n = 310) and Europe (n = 312) with symptomatic knee OA'],"['joint space narrowing (JSN', 'placebo']",['joint space width '],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C4517706', 'cui_str': '312 (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]","[{'cui': 'C1859695'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0224497', 'cui_str': 'Articular space (body structure)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}]",312.0,0.0635856,"JSW) stability over 2 years representing the most common trajectory (71%), which was unrelated to initial JSW.","[{'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Bartlett', 'Affiliation': 'McGill University Health Center, Montreal, Quebec, Canada. Susan.bartlett@mcgill.ca'}, {'ForeName': 'Shari M', 'Initials': 'SM', 'LastName': 'Ling', 'Affiliation': ''}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Mayo', 'Affiliation': ''}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Scott', 'Affiliation': ''}, {'ForeName': 'Clifton O', 'Initials': 'CO', 'LastName': 'Bingham', 'Affiliation': ''}]",Arthritis care & research,['10.1002/acr.20614']
869,32423935,Innovative equipment to monitor and control salt usage when cooking at home: iMC SALT research protocol for a randomised controlled trial.,"INTRODUCTION


Excessive salt intake is a public health concern due to its deleterious impact on health. Most of the salt consumed come from those that are added when cooking. This study will improve knowledge on the effectiveness of interventions to reduce salt consumption among consumers.
METHODS AND ANALYSIS


In this randomised clinical trial, we will be evaluating the efficacy of an intervention-the Salt Control H, an innovative prototype equipment to monitor and control use of salt when cooking-among workers from a public university, with the aim of reducing their dietary salt intake. We will randomly select 260 workers who meet the eligibility criteria and who are enrolled to an occupational health appointment and randomise them into one of the two arms of the study (either control or intervention), with matched baseline characteristics (sex and hypertension). The intervention will last for 8 weeks, during which the participants will use the equipment at home to monitor and control their use of salt when cooking. The main outcome will be 24-hour urinary sodium excretion at baseline, at fourth and eighth weeks of intervention, and at 6 months after intervention.
ETHICS AND DISSEMINATION


Ethical approval for the study has been obtained from the Ethics Committee of the Centro Hospitalar Universitário São João. The results of the investigation will be published in peer-reviewed scientific papers and presented at international conferences.
TRIAL REGISTRATION NUMBER


NCT03974477 EQUIPMENT PROVISIONAL PATENT NUMBER: Registered at INPI: 20191000033265.",2020,"In this randomised clinical trial, we will be evaluating the efficacy of an intervention-the Salt Control H, an innovative prototype equipment to monitor and control use of salt when cooking-among workers from a public university, with the aim of reducing their dietary salt intake.","['260 workers who meet the eligibility criteria and who are enrolled to an occupational health appointment and randomise them into one of the two arms of the study (either control or intervention), with matched baseline characteristics (sex and hypertension', 'workers from a public university']",[],['24-hour urinary sodium excretion'],"[{'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0079920', 'cui_str': 'Occupational Health'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0041740', 'cui_str': 'University'}]",[],"[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}]",,0.0781949,"In this randomised clinical trial, we will be evaluating the efficacy of an intervention-the Salt Control H, an innovative prototype equipment to monitor and control use of salt when cooking-among workers from a public university, with the aim of reducing their dietary salt intake.","[{'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Gonçalves', 'Affiliation': 'Faculdade de Ciências da Nutrição e Alimentação, Universidade do Porto, Porto, Portugal carlagoncalves.pt@gmail.com.'}, {'ForeName': 'Tânia', 'Initials': 'T', 'LastName': 'Silva-Santos', 'Affiliation': 'Faculdade de Ciências da Nutrição e Alimentação, Universidade do Porto, Porto, Portugal.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Abreu', 'Affiliation': 'CIAFEL - Centro de Investigação em Atividade Física, Saúde e Lazer, Universidade do Porto, Porto, Portugal.'}, {'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Padrão', 'Affiliation': 'Faculdade de Ciências da Nutrição e Alimentação, Universidade do Porto, Porto, Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Graça', 'Affiliation': 'Faculdade de Ciências da Nutrição e Alimentação, Universidade do Porto, Porto, Portugal.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Oliveira', 'Affiliation': 'INEGI - Instituto de Engenharia Mecânica e Gestão Industrial, Porto, Portugal.'}, {'ForeName': 'Sílvia', 'Initials': 'S', 'LastName': 'Esteves', 'Affiliation': 'INEGI - Instituto de Engenharia Mecânica e Gestão Industrial, Porto, Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Norton', 'Affiliation': 'UP EPIUnit - Institute of Public Health, Universidade do Porto, Porto, Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Moreira', 'Affiliation': 'Faculdade de Ciências da Nutrição e Alimentação, Universidade do Porto, Porto, Portugal.'}, {'ForeName': 'Olívia', 'Initials': 'O', 'LastName': 'Pinho', 'Affiliation': 'Faculdade de Ciências da Nutrição e Alimentação, Universidade do Porto, Porto, Portugal.'}]",BMJ open,['10.1136/bmjopen-2019-035898']
870,32005334,Randomized Controlled Trial of a Smartphone Application as an Adjunct to Acceptance and Commitment Therapy for Smoking Cessation.,"There is a major public health need for innovative and efficacious behavioral and cognitive interventions for smoking cessation. This randomized controlled trial evaluated the efficacy of an acceptance and commitment therapy (ACT) smartphone application in augmenting ACT group treatment for smoking cessation. One hundred fifty adults smoking 10 or more cigarettes per day were randomly assigned to 6 weekly group sessions of behavioral support, ACT, or ACT combined with the smartphone application. Access to the app was provided from the start of the in-person treatment until the 6-month follow-up assessment. Participants were encouraged to make their quit attempts after the third session, and the posttreatment assessment occurred 3 weeks later. Measures of smoking status and ACT processes were obtained at baseline, posttreatment, and 6-month follow-up. Biochemically verified quit rates in the combined, ACT, and behavioral support groups were 36% (p = .079 relative to ACT; p = .193 relative to behavioral support), 20% (p = .630 relative to behavioral support) and 24% at posttreatment, as compared with 24% (p = .630 relative to behavioral support), 24% (p = .630 relative to behavioral support) and 20% at follow-up. There was no significant difference (p = > .999) in the primary outcome of biochemically verified 7-day point-prevalence abstinence at 6-month follow-up between the combined and ACT groups. The combined group reported significantly greater smoking reduction, acceptance and present-moment awareness than the behavioral support group at posttreatment, but not at follow-up. There were no significant differences between the groups in positive mental health. Contrary to hypotheses, the ACT group did not display significant improvements in positive mental health or ACT processes relative to the behavioral support group at posttreatment or follow-up. Implications and directions for future research are discussed.",2020,"The combined group reported significantly greater smoking reduction, acceptance and present-moment awareness than the behavioral support group at posttreatment, but not at follow-up.","['smoking cessation', 'Smoking Cessation', 'One hundred fifty adults smoking 10 or more cigarettes per day']","['behavioral support, ACT, or ACT combined with the smartphone application', 'Smartphone Application', 'acceptance and commitment therapy (ACT) smartphone application']","['positive mental health', 'smoking reduction, acceptance and present-moment awareness', '7-day point-prevalence abstinence', 'quit rates', 'positive mental health or ACT processes', 'smoking status and ACT processes']","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",150.0,0.0415619,"The combined group reported significantly greater smoking reduction, acceptance and present-moment awareness than the behavioral support group at posttreatment, but not at follow-up.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': ""O'Connor"", 'Affiliation': 'University College Dublin. Electronic address: martin.o-connor.5@ucdconnect.ie.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Whelan', 'Affiliation': 'Trinity College Dublin, The University of Dublin.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Bricker', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Division of Public Health Sciences, Seattle, WA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'McHugh', 'Affiliation': 'University College Dublin.'}]",Behavior therapy,['10.1016/j.beth.2019.06.003']
871,32005343,Interpretation Bias Modification Versus Progressive Muscle Relaxation for Social Anxiety Disorder: A Web-Based Controlled Trial.,"Computerized interpretation bias modification (IBM) programs show promise for the treatment of anxiety disorders, though they have rarely been compared to active treatments. The goal of the present study was to compare the efficacy of IBM to progressive muscle relaxation (PMR) for the treatment of social anxiety disorder (SAD). Sixty-four participants with SAD were recruited from across the United States and randomly assigned to 8 internet-delivered twice-weekly sessions of IBM or PMR. Participants were administered assessments of primary symptom outcomes and interpersonal suicide risk factors at posttreatment and 3-month follow-up. IBM led to significantly lower negative interpretation bias than PMR at posttreatment but not follow-up. Both conditions experienced comparable reductions in social anxiety from pretreatment to follow-up (IBM d = 1.37, PMR d = 1.28). They also experienced significant reductions in depression and general anxiety that did not differ from one another. Additionally, IBM led to greater reductions in thwarted belongingness than PMR at posttreatment but not follow-up. Overall, these findings suggest IBM is not more effective than PMR for reducing social anxiety, though there was some evidence of its superiority in decreasing suicide risk. Limitations and directions for future research are discussed.",2020,"Additionally, IBM led to greater reductions in thwarted belongingness than PMR at posttreatment but not follow-up.","['social anxiety disorder (SAD', 'Sixty-four participants with SAD', 'Social Anxiety Disorder']","['IBM to progressive muscle relaxation (PMR', 'Computerized interpretation bias modification (IBM) programs', 'Interpretation Bias Modification Versus Progressive Muscle Relaxation', 'PMR', 'IBM or PMR', 'IBM']","['depression and general anxiety', 'interpersonal suicide risk factors', 'social anxiety']","[{'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C4517839', 'cui_str': '64'}]","[{'cui': 'C0004361', 'cui_str': 'Progressive Relaxation'}, {'cui': 'C0459471', 'cui_str': 'Interpretation (attribute)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0563664', 'cui_str': 'Suicide risk'}, {'cui': 'C0424166', 'cui_str': 'Social Anxiety'}]",64.0,0.0307006,"Additionally, IBM led to greater reductions in thwarted belongingness than PMR at posttreatment but not follow-up.","[{'ForeName': 'Jesse R', 'Initials': 'JR', 'LastName': 'Cougle', 'Affiliation': 'Florida State University. Electronic address: cougle@psy.fsu.edu.'}, {'ForeName': 'Natalie L', 'Initials': 'NL', 'LastName': 'Wilver', 'Affiliation': 'Florida State University.'}, {'ForeName': 'Taylor N', 'Initials': 'TN', 'LastName': 'Day', 'Affiliation': 'Florida State University.'}, {'ForeName': 'Berta J', 'Initials': 'BJ', 'LastName': 'Summers', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Okey', 'Affiliation': 'Arizona State University.'}, {'ForeName': 'Corinne N', 'Initials': 'CN', 'LastName': 'Carlton', 'Affiliation': 'Virginia Polytechnic Institute.'}]",Behavior therapy,['10.1016/j.beth.2019.05.009']
872,31855909,Changes on Tendon Stiffness and Clinical Outcomes in Athletes Are Associated With Patellar Tendinopathy After Eccentric Exercise.,"OBJECTIVE


Eccentric exercise is commonly used as a form of loading exercise for individuals with patellar tendinopathy. This study investigated the change of mechanical properties and clinical outcomes and their interrelationships after a 12-week single-legged decline-board exercise with and without extracorporeal shockwave therapy (ESWT).
DESIGN


Randomized controlled trial.
SETTING


Outpatient clinic of a university.
PARTICIPANTS


Thirty-four male in-season athletes with patellar tendinopathy for more than 3 months were randomized into exercise and combined groups.
INTERVENTIONS


The exercise group received a 12-week single-legged decline-squat exercise, and the combined group performed an identical exercise program in addition to a weekly session of ESWT in the initial 6 weeks.
MAIN OUTCOME MEASURES


Tendon stiffness and strain were examined using ultrasonography and dynamometry. Visual analog scale and Victoria Institute of Sports Assessment-patella (VISA-p) score were used to assess pain and dysfunction. These parameters were measured at preintervention and postintervention.
RESULTS


Significant time effect but no significant group effect on the outcome measures; significant reduction in tendon stiffness (P = 0.02) and increase in tendon strain (P = 0.00); and reduction of intensity of pain (P = 0.00) and dysfunction (P = 0.00) were observed. Significant correlations between changes in tendon stiffness and VISA-p score (ρ = -0.58, P = 0.05); alteration in tendon strain, pain intensity (ρ = -0.63, P = 0.03); and VISA-p score (ρ = 0.60, P = 0.04) were detected after the exercise program.
CONCLUSIONS


Eccentric exercise-induced modulation on tendon mechanical properties and clinical symptoms are associated in athletes with patellar tendinopathy.",2020,"RESULTS


Significant time effect but no significant group effect on the outcome measures; significant reduction in tendon stiffness (P = 0.02) and increase in tendon strain (P = 0.00); and reduction of intensity of pain (P = 0.00) and dysfunction (P = 0.00) were observed.","['Outpatient clinic of a university', 'athletes with patellar tendinopathy', 'individuals with patellar tendinopathy', 'Thirty-four male in-season athletes with patellar tendinopathy for more than 3 months']","['Eccentric exercise', 'single-legged decline-board exercise with and without extracorporeal shockwave therapy (ESWT', 'Eccentric exercise-induced modulation', '12-week single-legged decline-squat exercise, and the combined group performed an identical exercise program in addition to a weekly session of ESWT']","['Tendon Stiffness and Clinical Outcomes', 'pain and dysfunction', 'Visual analog scale and Victoria Institute of Sports Assessment-patella (VISA-p) score', 'Tendon stiffness and strain', 'reduction of intensity of pain', 'tendon stiffness and VISA-p score', 'tendon stiffness', 'tendon mechanical properties and clinical symptoms', 'tendon strain', 'tendon strain, pain intensity']","[{'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C1568272', 'cui_str': 'Tendinopathy'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0030647', 'cui_str': 'Kneecap'}, {'cui': 'C1318881', 'cui_str': 'Infection due to vancomycin intermediate Staphylococcus aureus'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0434303', 'cui_str': 'Tendon strain (disorder)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",34.0,0.0305104,"RESULTS


Significant time effect but no significant group effect on the outcome measures; significant reduction in tendon stiffness (P = 0.02) and increase in tendon strain (P = 0.00); and reduction of intensity of pain (P = 0.00) and dysfunction (P = 0.00) were observed.","[{'ForeName': 'Wai-Chun', 'Initials': 'WC', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}, {'ForeName': 'Gabriel Yin-Fat', 'Initials': 'GY', 'LastName': 'Ng', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}, {'ForeName': 'Zhi-Jie', 'Initials': 'ZJ', 'LastName': 'Zhang', 'Affiliation': 'Department of Physical Therapy, Luoyang Orthopedic Hospital of Henan Province, Luoyang, Henan, China.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Malliaras', 'Affiliation': 'Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Masci', 'Affiliation': 'Pure Sports Medicine, London, United Kingdom.'}, {'ForeName': 'Siu-Ngor', 'Initials': 'SN', 'LastName': 'Fu', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000562']
873,32423936,Effectiveness of a self-managed digital exercise programme to prevent falls in older community-dwelling adults: study protocol for the Safe Step randomised controlled trial.,"INTRODUCTION


Exercise interventions have a strong evidence base for falls prevention. However, exercise can be challenging to implement and often has limited reach and poor adherence. Digital technology provides opportunities for both increased access to the intervention and support over time. Further knowledge needs to be gained regarding the effectiveness of completely self-managed digital exercise interventions. The main objective of this study is to compare the effectiveness of a self-managed digital exercise programme, Safe Step, in combination with monthly educational videos with educational videos alone, on falls over 1 year in older community-dwelling adults.
METHODS AND ANALYSIS


A two-arm parallel randomised controlled trial will be conducted with at least 1400 community-living older adults (70+ years) who experience impaired balance. Participants will be recruited throughout Sweden with enrolment through the project website. They will be randomly allocated to either the Safe Step exercise programme with additional monthly educational videos about healthy ageing and fall prevention, or the monthly education videos alone. Participants receiving the exercise intervention will be asked to exercise at home for at least 30 min, 3 times/week with support of the Safe Step application. The primary outcome will be rate of falls (fall per person year). Participants will keep a fall calendar and report falls at the end of each month through a digital questionnaire. Further assessments of secondary outcomes will be made through self-reported questionnaires and a self-test of 30 s chair stand test at baseline and 3, 6, 9 and 12 months after study start. Data will be analysed according to the intention-to-treat principle.
ETHICS AND DISSEMINATION


Ethical approval was obtained by The Regional Ethical Review Board in Umeå (Dnr 2018/433-31). Findings will be disseminated through the project web-site, peer-reviewed journals, national and international conferences and through senior citizen organisations' newsletters.
TRIAL REGISTRATION NUMBER


NCT03963570.",2020,"They will be randomly allocated to either the Safe Step exercise programme with additional monthly educational videos about healthy ageing and fall prevention, or the monthly education videos alone.","['older community-dwelling adults', 'Participants will be recruited throughout Sweden with enrolment through the project website', '1400 community-living older adults (70+ years) who experience impaired balance']","['exercise intervention', 'self-managed digital exercise programme', 'self-managed digital exercise programme, Safe Step, in combination with monthly educational videos with educational videos alone', 'Safe Step exercise programme with additional monthly educational videos about healthy ageing and fall prevention, or the monthly education videos alone']",['rate of falls (fall per person year'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0557143', 'cui_str': 'Lives in a community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C2963171', 'cui_str': 'Healthy Ageing'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.158995,"They will be randomly allocated to either the Safe Step exercise programme with additional monthly educational videos about healthy ageing and fall prevention, or the monthly education videos alone.","[{'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Pettersson', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden beatrice.pettersson@umu.se.'}, {'ForeName': 'Lillemor', 'Initials': 'L', 'LastName': 'Lundin-Olsson', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Dawn A', 'Initials': 'DA', 'LastName': 'Skelton', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Liv', 'Affiliation': 'Department of Public Health and Clinical Medicine, Section of Sustainable Health, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Zingmark', 'Affiliation': 'Health and Social Care Administration, Municipality of Östersund, Östersund, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Rosendahl', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Sandlund', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden.'}]",BMJ open,['10.1136/bmjopen-2019-036194']
874,21495524,A randomized controlled trial to assess effectiveness of a spiritually-based intervention to help chronically ill adults.,"OBJECTIVE


Creative, cost-effective ways are needed to help older adults deal effectively with chronic diseases. Spiritual beliefs and practices are often used to deal with health problems. We evaluated whether a minimal intervention, consisting of a video and workbook encouraging use of patient spiritual coping, would be inoffensive and improve perceived health status.
METHODS


A randomized clinical trial of 100 older, chronically ill adults were assigned to a Spiritual (SPIRIT) or Educational (EDUC--standard cardiac risk reduction) intervention. Individuals in each group were shown a 28-minute video and given a workbook to complete over 4 weeks. Selected psychosocial and health outcome measures were administered at baseline and 6 weeks later.
RESULTS


Participants were mostly female (62%), with a mean age of 65.8 +/- 9.6 years and had an average of three chronic illnesses. More than 90% were Christian. At baseline, frequent daily spiritual experiences (DSE) were associated with being African American (p < .05) and increased pain (p < .01) and co-morbidities (p < or = .01). Energy increased significantly (p < .05) in the SPIRIT group and decreased in the EDUC group. Improvements in pain, mood, health perceptions, illness intrusiveness, and self-efficacy were not statistically significant.
CONCLUSIONS


A minimal intervention encouraging spiritual coping was inoffensive to patients, associated with increased energy, and required no additional clinician time.",2011,"At baseline, frequent daily spiritual experiences (DSE) were associated with being African American (p < .05) and increased pain (p < .01) and co-morbidities (p < or = .01).","['chronically ill adults', '100 older, chronically ill adults', 'Participants were mostly female (62%), with a mean age of 65.8 ']","['spiritually-based intervention', 'Spiritual (SPIRIT) or Educational (EDUC--standard cardiac risk reduction) intervention']","['co-morbidities', 'frequent daily spiritual experiences (DSE', 'pain', 'pain, mood, health perceptions, illness intrusiveness, and self-efficacy']","[{'cui': 'C0008715', 'cui_str': 'Chronically Ill'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",100.0,0.0728975,"At baseline, frequent daily spiritual experiences (DSE) were associated with being African American (p < .05) and increased pain (p < .01) and co-morbidities (p < or = .01).","[{'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'McCauley', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, Maryland 21202, USA. jmccauley430@yahoo.com'}, {'ForeName': 'Steffany', 'Initials': 'S', 'LastName': 'Haaz', 'Affiliation': ''}, {'ForeName': 'Margaret J', 'Initials': 'MJ', 'LastName': 'Tarpley', 'Affiliation': ''}, {'ForeName': 'Harold G', 'Initials': 'HG', 'LastName': 'Koenig', 'Affiliation': ''}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Bartlett', 'Affiliation': ''}]",International journal of psychiatry in medicine,[]
875,32423930,"Efficacy and safety of xuezhikang once per day versus two times per day in patients with mild to moderate hypercholesterolaemia (APEX study): a protocol for a multicentre, prospective randomised controlled, open-label, non-inferiority study.","INTRODUCTION


Reduction in low-density lipoprotein cholesterol (LDL-C) improves clinical outcomes in patients with coronary artery disease. However, rates of lipid-lowering medication adherence are far from ideal. Reducing dosage frequency from multiple dosing to once-daily dosing may improve patients' medication adherence. Xuezhikang (XZK), an extract of Chinese red yeast rice, contains a family of naturally occurring statins and is traditionally prescribed as 600 mg two times per day. A comParative Efficacy study of XZK (APEX study) is designed to test the hypothesis that XZK prescribed 1200 mg once per day (OD group) is non-inferior to 600 mg two times per day (TD group) in patients with hypercholesterolaemia.
METHODS AND ANALYSIS


The APEX study is a multicentre, prospective randomised controlled, open-label, non-inferiority study. We plan to recruit 316 patients aged ≥18 years with a diagnosis of mild to moderate hypercholesterolaemia for primary prevention. Patients will be randomised (1:1) to OD group and TD group. The OD group take XZK 1200 mg once per day after dinner while TD group take a traditional dose of 600 mg, two times per day after meals. Participants will have an 8-week medication period and be followed up at weeks 0, 4 and 8. The primary end point is the mean percentage change from baseline to week 8 in serum LDL-C. Secondary end points are safety and lipid-lowering effect on other lipoproteins and compliance. Data analyses will be on the intention-to-treat principle using non-inferiority analysis.
ETHICS AND DISSEMINATION


The research had been approved by the Clinical Research and Laboratory Animal Ethics Committee of the First Affiliated Hospital, Sun Yat-sen University ((2017)286). The results will be reported through peer-reviewed journals, seminars and conference presentations.
TRIAL REGISTRATION NUMBER


ChiCTR-IIR-17013660.",2020,The primary end point is the mean percentage change from baseline to week 8 in serum LDL-C. Secondary end points are safety and lipid-lowering effect on other lipoproteins and compliance.,"['patients with mild to moderate hypercholesterolaemia (APEX study', 'patients with hypercholesterolaemia', '316 patients aged ≥18 years with a diagnosis of mild to moderate hypercholesterolaemia for primary prevention', 'patients with coronary artery disease']","['XZK', 'xuezhikang', 'Xuezhikang (XZK']","['safety and lipid-lowering effect on other lipoproteins and compliance', 'rates of lipid-lowering medication adherence', 'Efficacy and safety', ""patients' medication adherence""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C1566069', 'cui_str': 'xuezhikang'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",316.0,0.138285,The primary end point is the mean percentage change from baseline to week 8 in serum LDL-C. Secondary end points are safety and lipid-lowering effect on other lipoproteins and compliance.,"[{'ForeName': 'Zexuan', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Dexi', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jingzhou', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Ailan', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Dong-Dan', 'Initials': 'DD', 'LastName': 'Zheng', 'Affiliation': 'Department of Cardiology, The Eastern Hospital of the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jianhao', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Central Hospital of Panyu District, Guangzhou, China.'}, {'ForeName': 'Yugang', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yili', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China yilichen2018@126.com.'}]",BMJ open,['10.1136/bmjopen-2019-034585']
876,32430452,Protocol of a randomised controlled trial assessing the impact of physical activity on bone health in children with inflammatory bowel disease.,"INTRODUCTION


Low bone mineral density (BMD) is a frequent issue in children and adolescents with inflammatory bowel disease (IBD). Several studies in healthy populations have reported a positive impact of physical activity (PA) on bone health. Recently, an observational study in paediatric patients with IBD showed a significant positive relationship between daily PA and BMD. However, intervention studies investigating a causal relationship between PA and BMD are warranted to confirm these results. The aim of this randomised controlled trial will be to investigate the effect of a PA programme on BMD in paediatric patients with IBD.
METHODS AND ANALYSIS


This trial is a multicentre (four centres), randomised, controlled, blinded end-point study. Eighty children with IBD will be randomly assigned in a 1:1 ratio to receive a programme with adapted physical exercises (intervention group) or usual PA (control group) during a 9-month period. The primary outcome is the change from baseline at 9 months (the end of the study) in whole-body BMD assessed by dual-energy X-ray absorptiometry. Secondary efficacy outcomes include the changes from baseline at 9 months in: BMD assessed in the lumbar spine and trochanter; daily PA (time spent in moderate-to-vigorous PA); body composition (fat mass and fat-free mass); fatigue resistance; quality of life and activity of IBD.
ETHICS AND DISSEMINATION


The study was approved by the Research Ethics Committee in France (Comité de Protection des Personnes, Sud-Ouest and Outre-Mer III, Bordeaux, France, No 2018/27). All procedures will be performed according to the ethical standards of the Helsinki Declaration of 1975, as revised in 2008, and the European Union's Guidelines for Good Clinical Practice. Written informed consent will be obtained from the parents or legal guardian and from the children. Research findings will be disseminated in peer-reviewed journals and scientific meetings.
TRIAL REGISTRATION NUMBER


NCT03774329.",2020,"Secondary efficacy outcomes include the changes from baseline at 9 months in: BMD assessed in the lumbar spine and trochanter; daily PA (time spent in moderate-to-vigorous PA); body composition (fat mass and fat-free mass); fatigue resistance; quality of life and activity of IBD.
ETHICS AND DISSEMINATION


","['children and adolescents with inflammatory bowel disease (IBD', 'healthy populations', 'Eighty children with IBD', 'paediatric patients with IBD', 'children with inflammatory bowel disease']","['PA programme', 'programme with adapted physical exercises (intervention group) or usual PA (control group', 'Low bone mineral density (BMD', 'physical activity']","['BMD assessed in the lumbar spine and trochanter; daily PA (time spent in moderate-to-vigorous PA); body composition (fat mass and fat-free mass); fatigue resistance; quality of life and activity of IBD.\nETHICS AND DISSEMINATION', 'bone health', 'whole-body BMD assessed by dual-energy X-ray absorptiometry']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0162370', 'cui_str': 'Trochanter'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0015000', 'cui_str': 'Ethics'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}]",80.0,0.174414,"Secondary efficacy outcomes include the changes from baseline at 9 months in: BMD assessed in the lumbar spine and trochanter; daily PA (time spent in moderate-to-vigorous PA); body composition (fat mass and fat-free mass); fatigue resistance; quality of life and activity of IBD.
ETHICS AND DISSEMINATION


","[{'ForeName': 'Jérémy', 'Initials': 'J', 'LastName': 'Vanhelst', 'Affiliation': 'Univ. Lille, Inserm, CHU Lille, U1286 - INFINITE - Institute for Translational Research in Inflammation, F-59000 Lille, France, Lille, France jeremy.vanhelst@chru-lille.fr.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Coopman', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Department of Paediatrics, Lille University, Jeanne de Flandre Children's Hospital, Lille, France.""}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': 'Univ. Lille, CHU Lille, ULR 2694 - METRICS: Evaluation des technologies de santé et des pratiques médicales, F-59000 Lille, France, Lille, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Dupont', 'Affiliation': 'Department of Paediatrics, Caen University Hospital F 14000 Caen, France and Normandy University, Caen, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Bertrand', 'Affiliation': 'Pediatric Unit, Le Havre Hospital, Le Havre, France.'}, {'ForeName': 'Djamal', 'Initials': 'D', 'LastName': 'Djeddi', 'Affiliation': 'Department of Paediatrics, Amiens University Hospital and University of Amiens, Amiens, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Turck', 'Affiliation': 'Univ. Lille, Inserm, CHU Lille, U1286 - INFINITE - Institute for Translational Research in Inflammation, F-59000 Lille, France, Lille, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Ley', 'Affiliation': 'Univ. Lille, Inserm, CHU Lille, U1286 - INFINITE - Institute for Translational Research in Inflammation, F-59000 Lille, France, Lille, France.'}]",BMJ open,['10.1136/bmjopen-2019-036400']
877,32430454,Effect of an editorial intervention to improve the completeness of reporting of randomised trials: a randomised controlled trial.,"OBJECTIVE


To evaluate the impact of an editorial intervention to improve completeness of reporting of reports of randomised trials.
DESIGN


Randomised controlled trial (RCT).
SETTING


BMJ Open 's quality improvement programme.
PARTICIPANTS


24 manuscripts describing RCTs.
INTERVENTIONS


We used an R Shiny application to randomise manuscripts (1:1 allocation ratio, blocks of 4) to the intervention (n=12) or control (n=12) group. The intervention was performed by a researcher with expertise in the content of the Consolidated Standards of Reporting Trials (CONSORT) and consisted of an evaluation of completeness of reporting of eight core CONSORT items using the submitted checklist to locate information, and the production of a report containing specific requests for authors based on the reporting issues found, provided alongside the peer review reports. The control group underwent the usual peer review.
OUTCOMES


The primary outcome is the number of adequately reported items (0-8 scale) in the revised manuscript after the first round of peer review. The main analysis was intention-to-treat (n=24), and we imputed the scores of lost to follow-up manuscripts (rejected after peer review and not resubmitted). The secondary outcome is the proportion of manuscripts where each item was adequately reported. Two blinded reviewers assessed the outcomes independently and in duplicate and solved disagreements by consensus. We also recorded the amount of time to perform the intervention.
RESULTS


Manuscripts in the intervention group (mean: 7.01; SD: 1.47) were more completely reported than those in the control group (mean: 5.68; SD: 1.43) (mean difference 1.43, 95% CI 0.31 to 2.58). We observed the main differences in items 6a (outcomes), 9 (allocation concealment mechanism), 11a (blinding) and 17a (outcomes and estimation). The mean time to perform the intervention was 87 (SD 42) min.
CONCLUSIONS


We demonstrated the benefit of involving a reporting guideline expert in the editorial process. Improving the completeness of RCTs is essential to enhance their usability.
TRIAL REGISTRATION NUMBER


NCT03751878.",2020,"RESULTS


Manuscripts in the intervention group",['24 manuscripts describing RCTs'],['editorial intervention'],"['proportion of manuscripts', 'number of adequately reported items (0-8 scale']","[{'cui': 'C0600659', 'cui_str': 'Manuscripts'}]","[{'cui': 'C0282412', 'cui_str': 'Editorial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0600659', 'cui_str': 'Manuscripts'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.116028,"RESULTS


Manuscripts in the intervention group","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Blanco', 'Affiliation': 'Statistics and Operations Research Department, Universitat Politecnica de Catalunya, Barcelona, Spain david.blanco.tena@upc.edu.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Schroter', 'Affiliation': 'The BMJ, London, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Aldcroft', 'Affiliation': 'The BMJ, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Moher', 'Affiliation': 'Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Boutron', 'Affiliation': 'Statistics and Operations Research Department, Universitat Politecnica de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Jamie J', 'Initials': 'JJ', 'LastName': 'Kirkham', 'Affiliation': 'Centre for Biostatistics, Manchester Academic Health Science Centre, Manchester University, Manchester, UK.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Cobo', 'Affiliation': 'Statistics and Operations Research Department, Universitat Politecnica de Catalunya, Barcelona, Spain.'}]",BMJ open,['10.1136/bmjopen-2020-036799']
878,31536624,"Comparison of Repeated Doses of Ivermectin Versus Ivermectin Plus Albendazole for the Treatment of Onchocerciasis: A Randomized, Open-label, Clinical Trial.","BACKGROUND


Improved treatment for onchocerciasis is needed to accelerate onchocerciasis elimination in Africa. Aiming to better exploit registered drugs, this study was undertaken to determine whether annual or semiannual treatment with ivermectin (IVM; 200 µg/kg) plus albendazole (ALB; 800 mg single dose) is superior to IVM alone.
METHODS


This trial was performed in Ghana and included 272 participants with microfilariae (MF), who were randomly assigned to 4 treatment arms: (1) IVM annually at 0, 12, and 24 months; (2) IVM semiannually at 0, 6, 12, 18, and 24 months; (3) IVM+ALB annually; or (4) IVM+ALB semiannually. Microfiladermia was determined pretreatment and at 6, 18, and 36 months. The primary outcome was the proportion of fertile and viable female worms in onchocercomata excised at 36 months.
RESULTS


Posttreatment nodule histology showed that 15/135 (11.1%), 22/155 (14.2%), 35/154 (22.7%), and 20/125 (16.0%) living female worms had normal embryogenesis in the IVM annual, IVM semiannual, IVM+ALB annual, and IVM+ALB semiannual groups, respectively (P = .1229). Proportions of dead worms also did not differ between the 4 groups (P = .9198). Proportions of patients without MF at 36 months (1 year after the last treatment) were 35/56 (63%) after annual IVM, 42/59 (71%) after semiannual IVM, 39/64 (61%) after annual IVM+ALB, and 43/53 (81%) after semiannual IVM+ALB.
CONCLUSIONS


The combination treatment of IVM plus ALB was no better than IVM alone for sterilizing, killing adult worms, or achieving sustained MF clearance. However, semiannual treatment was superior to annual treatment for achieving sustained clearance of Onchocerca volvulus MF from the skin (P = .024).
CLINICAL TRIALS REGISTRATION


ISRCTN50035143.",2020,"The combination treatment with IVM plus ALB was no better than IVM alone for sterilizing, killing of adult worms or achieving sustained MF clearance.",['Ghana and included 272 microfilaria (MF) -positive'],"['ivermectin (IVM; 200µg/kg) plus albendazole (ALB', 'ivermectin plus albendazole', 'IVM plus ALB', 'ivermectin']","['Microfiladermia', 'proportion of fertile and viable female worms in onchocercomata excised at 36 months']","[{'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0025980', 'cui_str': 'Microfilaria'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]","[{'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C0912730', 'cui_str': 'aluminum boride'}]","[{'cui': 'C0443348', 'cui_str': 'Viable (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0018889', 'cui_str': 'Helminthiasis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",,0.176554,"The combination treatment with IVM plus ALB was no better than IVM alone for sterilizing, killing of adult worms or achieving sustained MF clearance.","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Batsa Debrah', 'Affiliation': 'Kumasi Center for Collaborative Research, Kumasi, Ghana.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Klarmann-Schulz', 'Affiliation': 'Institute of Medical Microbiology, Immunology and Parasitology, University Hospital Bonn, Germany.'}, {'ForeName': 'Jubin', 'Initials': 'J', 'LastName': 'Osei-Mensah', 'Affiliation': 'Kumasi Center for Collaborative Research, Kumasi, Ghana.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Dubben', 'Affiliation': 'Institute of Medical Microbiology, Immunology and Parasitology, University Hospital Bonn, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Infectious Diseases Division, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Yusif', 'Initials': 'Y', 'LastName': 'Mubarik', 'Affiliation': 'Kumasi Center for Collaborative Research, Kumasi, Ghana.'}, {'ForeName': 'Nana Kwame', 'Initials': 'NK', 'LastName': 'Ayisi-Boateng', 'Affiliation': 'University Hospital, , Kumasi, Ghana.'}, {'ForeName': 'Arcangelo', 'Initials': 'A', 'LastName': 'Ricchiuto', 'Affiliation': 'Institute of Medical Microbiology, Immunology and Parasitology, University Hospital Bonn, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Fimmers', 'Affiliation': 'Institute for Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Konadu', 'Affiliation': 'School of Medicine and Dentistry, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Nadal', 'Affiliation': 'Institute for Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Gruetzmacher', 'Affiliation': 'Institute of Medical Microbiology, Immunology and Parasitology, University Hospital Bonn, Germany.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Weil', 'Affiliation': 'Infectious Diseases Division, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Kazura', 'Affiliation': 'Center for Global Health and Diseases, Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'King', 'Affiliation': 'Center for Global Health and Diseases, Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Alexander Y', 'Initials': 'AY', 'LastName': 'Debrah', 'Affiliation': 'Kumasi Center for Collaborative Research, Kumasi, Ghana.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Hoerauf', 'Affiliation': 'Institute of Medical Microbiology, Immunology and Parasitology, University Hospital Bonn, Germany.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz889']
879,32423937,"Effectiveness and acceptability of metformin in preventing the onset of type 2 diabetes after gestational diabetes in postnatal women: a protocol for a randomised, placebo-controlled, double-blind feasibility trial—Optimising health outcomes with Metformin to prevent diAbetes After pregnancy (OMAhA).","INTRODUCTION


Up to half of all women diagnosed with gestational diabetes mellitus develop type 2 diabetes within 5 years after delivery. Metformin is effective in preventing type 2 diabetes in high-risk non-pregnant individuals, but its effect when commenced in the postnatal period is not known. We plan to assess the feasibility of evaluating metformin versus placebo in minimising the risk of dysglycaemia including type 2 diabetes after delivery in postnatal women with a history of gestational diabetes through a randomised trial.
METHODS AND ANALYSIS


Optimising health outcomes with Metformin to prevent diAbetes After pregnancy (OMAhA) is a multicentre placebo-controlled double-blind randomised feasibility trial, where we will randomly allocate 160 postnatal women with gestational diabetes treated with medication to either metformin (intervention) or placebo (control) tablets to be taken until 1 year after delivery. The primary outcomes are rates of recruitment, randomisation, adherence and attrition. The secondary outcomes are maternal dysglycaemia, cost and quality of life outcomes in both arms, and acceptability of the study and intervention, which will be evaluated through a nested qualitative study. Feasibility outcomes will be summarised using descriptive statistics, point estimates and 95% CIs.
ETHICS AND DISSEMINATION


The OMAhA study received ethics approval from the London-Brent Research Ethics Committee (18/LO/0505). Trial findings will be published in a peer-reviewed journal, disseminated at conferences, through our Patient and Public Involvement advisory group (Katie's Team) and through social media platforms.
TRIAL REGISTRATION NUMBER


ISRCTN20930880.",2020,"The secondary outcomes are maternal dysglycaemia, cost and quality of life outcomes in both arms, and acceptability of the study and intervention, which will be evaluated through a nested qualitative study.","['women diagnosed with gestational diabetes mellitus develop type 2 diabetes within 5\u2009years after delivery', 'type 2 diabetes after gestational diabetes in postnatal women', '160 postnatal women with gestational diabetes treated with medication to either', 'diAbetes After pregnancy (OMAhA', 'to prevent diAbetes After pregnancy', 'postnatal women with a history of gestational diabetes']","['Metformin', 'metformin versus placebo', 'metformin', 'metformin (intervention) or placebo (control) tablets', 'placebo']","['maternal dysglycaemia, cost and quality of life outcomes in both arms, and acceptability of the study and intervention', 'rates of recruitment, randomisation, adherence and attrition', 'Effectiveness and acceptability']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",160.0,0.592804,"The secondary outcomes are maternal dysglycaemia, cost and quality of life outcomes in both arms, and acceptability of the study and intervention, which will be evaluated through a nested qualitative study.","[{'ForeName': 'Chiamaka Esther', 'Initials': 'CE', 'LastName': 'Amaefule', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK c.e.amaefule@qmul.ac.uk.""}, {'ForeName': 'Angeliki', 'Initials': 'A', 'LastName': 'Bolou', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Drymoussi', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Francisco Jose', 'Initials': 'FJ', 'LastName': 'Gonzalez Carreras', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Maria Del Carmen', 'Initials': 'MDC', 'LastName': 'Pardo Llorente', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Lanz', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dodds', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Sweeney', 'Affiliation': 'Institute for Health and Human Development, University of East London, London, UK.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pizzo', 'Affiliation': 'Collaborations for Leadership in Applied Health Research and Care (CLAHRC) for North Thames London, Department of Applied Health Research, University College London, London, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': ""D'Amico"", 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Heighway', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Jahnavi', 'Initials': 'J', 'LastName': 'Daru', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Soha', 'Initials': 'S', 'LastName': 'Sobhy', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Robson', 'Affiliation': 'Clinical Effectiveness Group, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Sanghi', 'Affiliation': ""Women's Division, Royal London Hospital, Barts Health NHS Trust, London, UK.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Zamora', 'Affiliation': 'Clinical Biostatistics Unit (IRYCIS) and CIBER Epidemiology and Public Health, Ramon y Cajal University Hospital, Madrid, Spain.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Harden', 'Affiliation': 'Institute for Health and Human Development, University of East London, London, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Hitman', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Khan', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Pérez', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Mohammed Sb', 'Initials': 'MS', 'LastName': 'Huda', 'Affiliation': 'Department of Diabetes and Metabolism, Barts Health NHS Trust, Royal London Hospital, London, UK.'}, {'ForeName': 'Shakila', 'Initials': 'S', 'LastName': 'Thangaratinam', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}]",BMJ open,['10.1136/bmjopen-2019-036198']
880,21130060,Effect of electromyogram biofeedback on daytime clenching behavior in subjects with masticatory muscle pain.,"PURPOSE


Although daytime clenching is believed to be one of the oral parafunctions leading to dental problems, a treatment strategy has not yet been devised. Electromyogram (EMG) biofeedback training was performed to ascertain its effect on the regulation of daytime clenching behavior.
MATERIALS AND METHODS


Twenty subjects (mean age, 30.9±5.6 years) who had mild to moderate masticatory muscle pain with daytime clenching behavior were randomly divided into either a biofeedback group (BF) or control group (CO). Subjects were fitted with a hearing-aid-shaped EMG recording and biofeedback apparatus which was used to record EMG data under natural conditions from the temporal muscle, continuously for five hours on four consecutive days. EMG data on Days 1 and 4 were recorded without biofeedback as pre-test and post-test, respectively, and on Days 2 and 3, subjects in the BF group noticed their clenching behaviors via an alert sound from the EMG biofeedback apparatus. No alert sound was given for the CO group throughout the recording sessions.
RESULTS


There was no significant difference in the number of clenching events for five hours between the BF group (4.6±2.5) and CO group (4.6±0.9) on Day 1, however a significant decrease was found in the BF group between Day 1 (4.6±2.5) and Day 4 (2.4±1.7; P<0.05).
CONCLUSION


Daytime clenching was reduced in the short-term with the help of an EMG biofeedback system under natural circumstances. Further research is needed to confirm a long-lasting effect.",2011,Daytime clenching was reduced in the short-term with the help of an EMG biofeedback system under natural circumstances.,"['Twenty subjects (mean age, 30.9±5.6 years) who had mild to moderate masticatory muscle pain with daytime clenching behavior', 'subjects with masticatory muscle pain']","['Electromyogram (EMG) biofeedback training', 'electromyogram biofeedback', 'hearing-aid-shaped EMG recording and biofeedback apparatus', 'biofeedback group (BF) or control group (CO']","['Daytime clenching', 'daytime clenching behavior', 'number of clenching events']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0024890', 'cui_str': 'Masticatory muscles'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0018768', 'cui_str': 'Hearing Aids'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0243111', 'cui_str': 'apparatus'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",20.0,0.0141286,Daytime clenching was reduced in the short-term with the help of an EMG biofeedback system under natural circumstances.,"[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Watanabe', 'Affiliation': 'Department of Fixed Prosthodontics, School of Dentistry, Iwate Medical University, 1-3-27 Chuodori, Morioka, Iwate 020-8505, Japan. akira04101980@yahoo.co.jp'}, {'ForeName': 'Kiyotaka', 'Initials': 'K', 'LastName': 'Kanemura', 'Affiliation': ''}, {'ForeName': 'Norimasa', 'Initials': 'N', 'LastName': 'Tanabe', 'Affiliation': ''}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Fujisawa', 'Affiliation': ''}]",Journal of prosthodontic research,['10.1016/j.jpor.2010.09.003']
881,31801446,Impact of Recruitment Maneuvers to Cover Adverse Effects of Donor Transfer.,"OBJECTIVES


Our aim was to investigate the negative effects of transferring brain-dead donors to the intensive care unit on the ratio of PaO₂ to inspired oxygen fraction and the benefits of recruitment maneuvers on its reversal.
MATERIALS AND METHODS


In this randomized trial, we assigned 30 brain-dead donors to an intervention group and a control group. After transfer to the intensive care unit, donors in the intervention group received a lung recruitment maneuver according to protocol for 1 hour, whereas the control group did not receive this intervention. Arterial blood gas was drawn before transfer, immediately aftertransfer, and 3 hours after transfer.
RESULTS


Before transfer to immediately after transfer, the PaO₂-to-inspired oxygen fraction ratio decreased from 281.30 ± 100.33 to 225.03 ± 95.72 mm Hg (P < .01). At 3 hours aftertransfer,the PaO₂-to-inspired oxygen fraction ratio in the intervention and control groups was 280.4 ± 120.4 and 213.4 ± 75.5 mm Hg (P = .017), respectively. The absolute difference in PaO₂-to-inspired oxygen fraction ratio from before to 3 hours after transfer was -16.9 ± 44.1 and 51.8 ± 61.4 mm Hg (P < .001), in the intervention and control groups,respectively. Increasing central venous pressure and/or transfer time further potentiated the decrease ofthe PaO₂-to-inspired oxygen fraction ratio.
CONCLUSIONS


The PaO₂-to-inspired oxygen fraction ratio decreased after transfer of brain-dead donors to the intensive care unit. This was partially reversible by standardized recruitment maneuvers.",2020,"Increasing central venous pressure and/or transfer time further potentiated the decrease ofthe PaO2-to-inspired oxygen fraction ratio.
",[],"['Materials and Methods', 'lung recruitment maneuver according to protocol for 1 hour, whereas the control group did not receive this intervention']","['PaO2-to-inspired oxygen fraction ratio', 'Arterial blood gas']",[],"[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C1822073', 'cui_str': 'PaO2'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}]",30.0,0.0399117,"Increasing central venous pressure and/or transfer time further potentiated the decrease ofthe PaO2-to-inspired oxygen fraction ratio.
","[{'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Ghorbani', 'Affiliation': 'From Tracheal Diseases Research Center (TDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences (SBMU), Tehran, Iran.'}, {'ForeName': 'Katayoun', 'Initials': 'K', 'LastName': 'Najafizadeh', 'Affiliation': ''}, {'ForeName': 'Carl-Ludwig', 'Initials': 'CL', 'LastName': 'Fischer-Fröhlich', 'Affiliation': ''}, {'ForeName': 'Meysam', 'Initials': 'M', 'LastName': 'Mojtabaee', 'Affiliation': ''}]",Experimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation,['10.6002/ect.2019.0236']
882,31531707,Co-ingestion of whey protein hydrolysate with milk minerals rich in calcium potently stimulates glucagon-like peptide-1 secretion: an RCT in healthy adults.,"PURPOSE


To examine whether calcium type and co-ingestion with protein alter gut hormone availability.
METHODS


Healthy adults aged 26 ± 7 years (mean ± SD) completed three randomized, double-blind, crossover studies. In all studies, arterialized blood was sampled postprandially over 120 min to determine GLP-1, GIP and PYY responses, alongside appetite ratings, energy expenditure and blood pressure. In study 1 (n = 20), three treatments matched for total calcium content (1058 mg) were compared: calcium citrate (CALCITR); milk minerals rich in calcium (MILK MINERALS); and milk minerals rich in calcium plus co-ingestion of 50 g whey protein hydrolysate (MILK MINERALS + PROTEIN). In study 2 (n = 6), 50 g whey protein hydrolysate (PROTEIN) was compared to MILK MINERALS + PROTEIN. In study 3 (n = 6), MILK MINERALS was compared to the vehicle of ingestion (water plus sucralose; CONTROL).
RESULTS


MILK MINERALS + PROTEIN increased GLP-1 incremental area under the curve (iAUC) by ~ ninefold (43.7 ± 11.1 pmol L -1  120 min; p < 0.001) versus both CALCITR and MILK MINERALS, with no difference detected between CALCITR (6.6 ± 3.7 pmol L -1  120 min) and MILK MINERALS (5.3 ± 3.5 pmol L -1  120 min; p > 0.999). MILK MINERALS + PROTEIN produced a GLP-1 iAUC ~ 25% greater than PROTEIN (p = 0.024; mean difference: 9.1 ± 6.9 pmol L -1  120 min), whereas the difference between MILK MINERALS versus CONTROL was small and non-significant (p = 0.098; mean difference: 4.2 ± 5.1 pmol L -1  120 min).
CONCLUSIONS


When ingested alone, milk minerals rich in calcium do not increase GLP-1 secretion compared to calcium citrate. Co-ingesting high-dose whey protein hydrolysate with milk minerals rich in calcium increases postprandial GLP-1 concentrations to some of the highest physiological levels ever reported. Registered at ClinicalTrials.gov: NCT03232034, NCT03370484, NCT03370497.",2020,"MILK MINERALS + PROTEIN produced a GLP-1 iAUC ~ 25% greater than PROTEIN (p = 0.024; mean difference: 9.1 ± 6.9 pmol L -1  120 min), whereas the difference between MILK MINERALS versus CONTROL was small and non-significant (p = 0.098; mean difference: 4.2 ± 5.1 pmol ","['Healthy adults aged 26\u2009±\u20097\xa0years (mean\u2009±\u2009SD', 'healthy adults', '50']","['calcium citrate (CALCITR); milk minerals rich in calcium (MILK MINERALS); and milk minerals rich in calcium plus', 'L -1', 'total calcium content', 'pmol\xa0L -1']","['increased GLP-1 incremental area under the curve (iAUC', 'GLP-1 secretion', 'GLP-1, GIP and PYY responses, alongside appetite ratings, energy expenditure and blood pressure']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0108101', 'cui_str': 'Calcium Citrate'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0673362', 'cui_str': 'L-1 (ester)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0439192', 'cui_str': 'pmol'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0070358', 'cui_str': 'PYY Peptide'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",,0.024686,"MILK MINERALS + PROTEIN produced a GLP-1 iAUC ~ 25% greater than PROTEIN (p = 0.024; mean difference: 9.1 ± 6.9 pmol L -1  120 min), whereas the difference between MILK MINERALS versus CONTROL was small and non-significant (p = 0.098; mean difference: 4.2 ± 5.1 pmol ","[{'ForeName': 'Yung-Chih', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Harry A', 'Initials': 'HA', 'LastName': 'Smith', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Hengist', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Oliver J', 'Initials': 'OJ', 'LastName': 'Chrzanowski-Smith', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Ulla Ramer', 'Initials': 'UR', 'LastName': 'Mikkelsen', 'Affiliation': 'Arla Foods Ingredients Group P/S, Viby J, Denmark.'}, {'ForeName': 'Harriet A', 'Initials': 'HA', 'LastName': 'Carroll', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Saunders', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK. J.T.Gonzalez@bath.ac.uk.'}]",European journal of nutrition,['10.1007/s00394-019-02092-4']
883,32430450,"Cannabidiol (CBD) and Δ 9 -tetrahydrocannabinol (THC) for chronic insomnia disorder ('CANSLEEP' trial): protocol for a randomised, placebo-controlled, double-blinded, proof-of-concept trial.","INTRODUCTION


Insomnia is a highly prevalent and costly condition that is associated with increased health risks and healthcare utilisation. Anecdotally, cannabis use is frequently reported by consumers to promote sleep. However, there is limited research on the effects of cannabis on sleep and daytime function in people with insomnia disorder using objective measures. This proof-of-concept study will evaluate the effects of a single dose of an oral cannabis-based medicine on sleep and daytime function in participants with chronic insomnia disorder.
METHODS AND ANALYSIS


A randomised, crossover, placebo-controlled, single-dose study design will be used to test the safety and efficacy of an oral oil solution ('ETC120') containing 10 mg Δ 9 -tetrahydrocannabinol (THC) and 200 mg cannabidiol (CBD) in 20 participants diagnosed with chronic insomnia disorder. Participants aged 35-60 years will be recruited over an 18-month period commencing August 2019. Each participant will receive both the active drug and matched placebo, in a counterbalanced order, during two overnight study assessment visits, with at least a 1-week washout period between each visit. The primary outcomes are total sleep time and wake after sleep onset assessed via polysomnography. In addition, 256-channel high-density electroencephalography and source modelling using structural brain MRI will be used to comprehensively examine brain activation during sleep and wake periods on ETC120 versus placebo. Next-day cognitive function, alertness and simulated driving performance will also be investigated.
ETHICS AND DISSEMINATION


Ethics approval was received from Bellberry Human Research Ethics Committee (2018-04-284). The findings will be disseminated in a peer-reviewed open-access journal and at academic conferences.
TRIAL REGISTRATION NUMBER


ANZCTRN12619000714189.",2020,"Each participant will receive both the active drug and matched placebo, in a counterbalanced order, during two overnight study assessment visits, with at least a 1-week washout period between each visit.","['20 participants diagnosed with chronic insomnia disorder', 'participants with chronic insomnia disorder', 'people with insomnia disorder', 'Participants aged 35-60 years will be recruited over an 18-month period commencing August 2019']","['Cannabidiol (CBD) and Δ 9 -tetrahydrocannabinol (THC', ""oral oil solution ('ETC120') containing 10\u2009mg Δ 9 -tetrahydrocannabinol (THC) and 200\u2009mg cannabidiol (CBD"", 'oral cannabis-based medicine', 'active drug and matched placebo', 'placebo']","['sleep and daytime function', 'safety and efficacy', 'total sleep time and wake after sleep onset assessed via polysomnography']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}]",20.0,0.542876,"Each participant will receive both the active drug and matched placebo, in a counterbalanced order, during two overnight study assessment visits, with at least a 1-week washout period between each visit.","[{'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Suraev', 'Affiliation': 'Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Grunstein', 'Affiliation': 'Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Nathaniel S', 'Initials': 'NS', 'LastName': 'Marshall', 'Affiliation': 'Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': ""D'Rozario"", 'Affiliation': 'Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Gordon', 'Affiliation': 'Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Delwyn J', 'Initials': 'DJ', 'LastName': 'Bartlett', 'Affiliation': 'Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wong', 'Affiliation': 'Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Brendon J', 'Initials': 'BJ', 'LastName': 'Yee', 'Affiliation': 'Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Vandrey', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Irwin', 'Affiliation': 'Menzies Health Institute Queensland, School Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Jonathon C', 'Initials': 'JC', 'LastName': 'Arnold', 'Affiliation': 'The University of Sydney, Lambert Initiative for Cannabinoid Therapeutics, Sydney, New South Wales, Australia.'}, {'ForeName': 'Iain S', 'Initials': 'IS', 'LastName': 'McGregor', 'Affiliation': 'The University of Sydney, Lambert Initiative for Cannabinoid Therapeutics, Sydney, New South Wales, Australia.'}, {'ForeName': 'Camilla M', 'Initials': 'CM', 'LastName': 'Hoyos', 'Affiliation': 'Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Sydney, New South Wales, Australia camilla.hoyos@sydney.edu.au.'}]",BMJ open,['10.1136/bmjopen-2019-034421']
884,21296638,No effect of conscious clenching on simple arithmetic task in healthy participants.,"PURPOSE


This study aimed to investigate whether clenching aids performance in a task requiring mental concentration in healthy participants.
MATERIALS AND METHODS


Twenty healthy participants (an average of 26.8 ± 2.0 years, nine females and 11 males) were recruited from our department. Participants performed four sets of hundred-square calculations as a mental arithmetic task. Among these sets, the third and the fourth sets were randomly divided into two conditions: one condition where participants made an effort to not allow their teeth to touch ('no tooth-contact' condition), and another where they made a conscious effort to rhythmically clench their teeth ('clenching' condition) during the task. Surface EMG was recorded from the left masseter muscle. Arithmetic performance was compared between the tooth-contact and clenching conditions using paired t-tests. In addition, we computed Pearson product-moment coefficients of the correlations between the difference in EMG activity and arithmetic performance in the two conditions.
RESULTS


No significant change in arithmetic score was found between the no tooth-contact (68.8 ± 12.2) and clenching conditions (66.5 ± 12.7; P=0.27). No significant correlation was found between the difference in EMG activity and changes in arithmetic performance (r=0.32, P=0.17).
CONCLUSION


In healthy participants, conscious clenching was not associated with any benefit in arithmetic performance. Although our study was limited by only measuring the short-term effects of clenching on a simple arithmetic task, the results indicate that it may not be harmful for clinicians to encourage their patients to refrain from clenching their teeth.",2011,No significant change in arithmetic score was found between the no tooth-contact (68.8 ± 12.2) and clenching conditions (66.5 ± 12.7; P=0.27).,"['Twenty healthy participants (an average of 26.8 ± 2.0 years, nine females and 11 males', 'healthy participants']","['conscious clenching', 'clenching aids performance']","['conscious clenching', 'EMG activity and changes in arithmetic performance', 'Surface EMG', 'simple arithmetic task', 'arithmetic score', 'Arithmetic performance', 'EMG activity and arithmetic performance']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}]",[],"[{'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0430815', 'cui_str': 'Surface Electromyography'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",20.0,0.0199822,No significant change in arithmetic score was found between the no tooth-contact (68.8 ± 12.2) and clenching conditions (66.5 ± 12.7; P=0.27).,"[{'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Mizumori', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, Osaka, Japan. tmizumor@dent.osaka-u.ac.jp'}, {'ForeName': 'Yasuyoshi', 'Initials': 'Y', 'LastName': 'Kobayashi', 'Affiliation': ''}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Inano', 'Affiliation': ''}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Sumiya', 'Affiliation': ''}, {'ForeName': 'Fumiko', 'Initials': 'F', 'LastName': 'Murashima', 'Affiliation': ''}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Yatani', 'Affiliation': ''}]",Journal of prosthodontic research,['10.1016/j.jpor.2010.12.004']
885,32423941,Internet-based cognitive-behavioural therapy for prevention of depression during pregnancy and in the post partum (iPDP): a protocol for a large-scale randomised controlled trial.,"INTRODUCTION


The objective of this randomised controlled trial (RCT) is to examine the effects of smartphone-based cognitive-behavioural therapy (CBT) in preventing the onset of major depressive episodes (MDE) among pregnant women.
METHODS AND ANALYSIS


The target study population will be pregnant women of 16-20 weeks gestation who are currently users of 'Luna Luna Baby', the most widely used app for pregnant women in Japan. Those who meet the eligibility criteria will be randomly allocated to the 6-module internet CBT programme that was newly developed for pregnant women (n=2500), or to a treatment-as-usual control group (n=2500). Participants in the intervention groups will be required to complete the programme by 32 weeks gestation. The primary outcomes are the number of new onsets of MDE, measured by using WHO Composite International Diagnostic Interview 3.0 at 32 weeks gestation and 3 months post partum. Survival analysis will be conducted to test for the effectiveness of the intervention on the time to the onset of MDE.
ETHICS AND DISSEMINATION


The study plan has been approved by the Research Ethics Review Board of the Graduate School of Medicine/Faculty of Medicine, the University of Tokyo (2019150NI). If the intervention programmes are found to produce a significant positive effect in this RCT, these programmes can be made available for all users of the app in the future.
TRIAL REGISTRATION NUMBER


UMIN000038190; Pre-results.",2020,"The objective of this randomised controlled trial (RCT) is to examine the effects of smartphone-based cognitive-behavioural therapy (CBT) in preventing the onset of major depressive episodes (MDE) among pregnant women.
","[""pregnant women of 16-20 weeks gestation who are currently users of 'Luna Luna Baby', the most widely used app for pregnant women in Japan"", 'pregnant women']","['6-module internet CBT programme', 'Internet-based cognitive-behavioural therapy', 'smartphone-based cognitive-behavioural therapy (CBT']","['number of new onsets of MDE, measured by using WHO Composite International Diagnostic Interview']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451085', 'cui_str': 'Composite international diagnostic interview'}]",,0.184564,"The objective of this randomised controlled trial (RCT) is to examine the effects of smartphone-based cognitive-behavioural therapy (CBT) in preventing the onset of major depressive episodes (MDE) among pregnant women.
","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Nishi', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan d-nishi@m.u-tokyo.ac.jp.'}, {'ForeName': 'Kotaro', 'Initials': 'K', 'LastName': 'Imamura', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Obikane', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Natsu', 'Initials': 'N', 'LastName': 'Sasaki', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Naonori', 'Initials': 'N', 'LastName': 'Yasuma', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Sekiya', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Matsuyama', 'Affiliation': 'Department of Biostatistics, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Norito', 'Initials': 'N', 'LastName': 'Kawakami', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}]",BMJ open,['10.1136/bmjopen-2019-036482']
886,31535213,"Soy isoflavones interact with calcium and contribute to blood pressure homeostasis in women: a randomized, double-blind, placebo controlled trial.","BACKGROUND


Estrogens and calcium regulate vascular health but caused adverse cardiovascular events in randomized trials.
OBJECTIVES


Whether phytoestrogenic soy isoflavones modulate the physiological effects of calcium on blood pressure was explored.
DESIGN


A double-blind, randomized study assigned 99 premenopausal women to 136.6 mg isoflavones (as aglycone equivalents) and 98 to placebo for 5 days per week for up to 2 years. Blood pressure, serum calcium and urinary excretion of daidzein (DE) and genistein (GE) were measured repeatedly before and during treatment.
RESULTS


Isoflavones did not affect blood pressure per intake dose assignment (i.e. intention-to-treat, n = 197), but significantly affected blood pressure per measured urinary excretion of isoflavones (i.e. per protocol analysis, n = 166). Isoflavones inversely moderated calcium effects on systolic blood pressure (SBP) (interaction term β-estimates: - 3.1 for DE, - 12.86 for GE, all P < 0.05), and decreased diastolic blood pressure (DBP) (β-estimates: - 0.84 for DE, - 2.82 for GE, all P < 0.05) after controlling for calcium. The net intervention effects between the maximum and no isoflavone excretion were - 17.7 and + 13.8 mmHg changes of SBP, respectively, at serum calcium of 10.61 and 8.0 mg/dL, and about 2.6 mmHg decrease of DBP.
CONCLUSIONS


Moderation by isoflavones of the physiological effect of calcium tends to normalize SBP, and this effect is most significant when calcium concentrations are at the upper and lower limits of the physiological norm. Isoflavones decrease DBP independent of calcium levels. Further studies are needed to assess the impact of this novel micronutrient effect on blood pressure homeostasis and cardiovascular health.
TRIAL REGISTRATION


www.clinicaltrials.gov identifier: NCT00204490.",2020,"Blood pressure, serum calcium and urinary excretion of daidzein (DE) and genistein (GE) were measured repeatedly before and during treatment.
","['99 premenopausal women to 136.6\xa0mg isoflavones (as aglycone equivalents) and 98 to', 'women']","['placebo', 'Soy isoflavones interact with calcium', 'Isoflavones', 'phytoestrogenic soy isoflavones']","['blood pressure', 'DBP', 'blood pressure homeostasis', 'systolic blood pressure (SBP', 'Blood pressure, serum calcium and urinary excretion of daidzein (DE) and genistein (GE', 'blood pressure per measured urinary excretion of isoflavones', 'diastolic blood pressure (DBP', 'isoflavone excretion']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0304518', 'cui_str': 'Aglycone'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4076257', 'cui_str': 'Soy isoflavone (substance)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0057090', 'cui_str': 'diadzein'}, {'cui': 'C0061202', 'cui_str': 'Genistein'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}]",,0.508317,"Blood pressure, serum calcium and urinary excretion of daidzein (DE) and genistein (GE) were measured repeatedly before and during treatment.
","[{'ForeName': 'Lee-Jane W', 'Initials': 'LW', 'LastName': 'Lu', 'Affiliation': 'Department of Preventive Medicine and Community Health, The University of Texas Medical Branch, 700 Harborside Dr., Galveston, TX, 77555-1109, USA. llu@utmb.edu.'}, {'ForeName': 'Nai-Wei', 'Initials': 'NW', 'LastName': 'Chen', 'Affiliation': 'Department of Preventive Medicine and Community Health, The University of Texas Medical Branch, 700 Harborside Dr., Galveston, TX, 77555-1109, USA.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Nayeem', 'Affiliation': 'Department of Preventive Medicine and Community Health, The University of Texas Medical Branch, 700 Harborside Dr., Galveston, TX, 77555-1109, USA.'}, {'ForeName': 'Manubai', 'Initials': 'M', 'LastName': 'Nagamani', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch, 301 University Blvd, Galveston, TX, 77555, USA.'}, {'ForeName': 'Karl E', 'Initials': 'KE', 'LastName': 'Anderson', 'Affiliation': 'Department of Preventive Medicine and Community Health, The University of Texas Medical Branch, 700 Harborside Dr., Galveston, TX, 77555-1109, USA. kanderso@utmb.edu.'}]",European journal of nutrition,['10.1007/s00394-019-02085-3']
887,31521870,Tyrosine negatively affects flexible-like behaviour under cognitively demanding conditions.,"BACKGROUND


The catecholaminergic precursor to dopamine, tyrosine, is an important modulator of cognitive performance. A number of studies have demonstrated that the beneficial effects of tyrosine on cognitive performance are most pronounced when individuals are exposed to stressful situations, such as hypothermia. However, little is known about whether manipulation of stress using non-aversive stimuli, such as cognitive demand, can also bring about similar improvements.
METHODS


We conducted a randomized, double-blind, placebo-controlled experiment to test the effects of tyrosine administration and cognitive load (low or high) on cognitive flexibility, a measure known to be influenced by catecholaminergic function. A total of 70 healthy volunteers completed a baseline cognitive flexibility test (Wisconsin Card Sorting Test: WCST). Participants were given a dose of either tyrosine (2.0 g) or placebo (cellulose) and subject to either low cognitive load (simple reaction time task) or high cognitive load (digit memory span task), immediately followed by a WCST for a second time.
RESULTS


Contrary to expectations, we found that instead of ameliorating performance under the high cognitive load condition, tyrosine worsened cognitive flexibility.
LIMITATIONS


Physiological marker of stress was not measured.
CONCLUSIONS


Our results suggest that aversive stressors and cognitive demand modulate the effects of tyrosine on cognitive performance in a differential manner.",2020,"Contrary to expectations, we found that instead of ameliorating performance under the high cognitive load condition, tyrosine worsened cognitive flexibility.
",['70 healthy volunteers'],"['baseline cognitive flexibility test (Wisconsin Card Sorting Test: WCST', 'placebo', 'tyrosine', 'tyrosine administration and cognitive load (low or high', 'placebo (cellulose) and subject to either low cognitive load (simple reaction time task) or high cognitive load (digit memory span task), immediately followed by a WCST']","['cognitive performance', 'cognitive flexibility']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0451592', 'cui_str': 'Wisconsin Card Sorting Test'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0041485', 'cui_str': 'L-tyrosine'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}]",70.0,0.138341,"Contrary to expectations, we found that instead of ameliorating performance under the high cognitive load condition, tyrosine worsened cognitive flexibility.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Robson', 'Affiliation': 'Department of Psychology, Sociology and Politics, Sheffield Hallam University, Sheffield, United Kingdom. Electronic address: ar2091@exchange.shu.ac.uk.'}, {'ForeName': 'Lee Wei', 'Initials': 'LW', 'LastName': 'Lim', 'Affiliation': 'School of Biomedical Sciences, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pok Fu Lam, Hong Kong, China.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Aquili', 'Affiliation': 'Department of Psychology, Sociology and Politics, Sheffield Hallam University, Sheffield, United Kingdom.'}]",Journal of affective disorders,['10.1016/j.jad.2019.09.031']
888,32430445,Patient-centred and economic effectiveness of a decision aid for patients with age-related cataract in China: study protocol of a randomised controlled trial.,"INTRODUCTION


The need for cataract surgery is on the rise due to our ageing population and high demands for greater visual functioning. Although the majority of patients want to participate in a shared decision-making process, no decision aid has been available to improve the quality of decision. The present study aims to determine whether a decision aid increases informed decision about cataract surgery.
METHODS AND ANALYSIS


A parallel randomised controlled trial (772 participants) will be conducted. The decision aid will be implemented among patients with any age-related cataract in Yuexiu District, which is socioeconomically representative of a major metropolitan region in Southern China. Participants will be randomly assigned to receive either a patient decision aid or a traditional booklet, and they will complete three surveys: (1) baseline assessment before the intervention (time point (T)1), 2 weeks (T2) and 1 year (T3) after the intervention. The control group receives a traditional booklet with standard general information developed by the National Eye Institute to help patients understand cataract, whereas the intervention group receives a patient decision aid that includes not only the standard general information, but also the quantitative risk information on the possible outcomes of cataract surgery as well as value clarification exercise. The primary study outcome is the informed decision, the percentage of patients who have adequate knowledge and demonstrate consistency between attitudes and intentions. Secondary outcomes include perceived importance of cataract surgery benefits/harms, decision conflict and confidence, anticipated regret and booklet utilisation and acceptability at 2 weeks, and surgical rates and a cost-utility estimate of the decision aid at 1 year.
ETHICS AND DISSEMINATION


Ethics approval was obtained from the Ethics Committee of Zhongshan Ophthalmic Center (reference number: 2019KYPJ090). Results will be published in peer-reviewed journals and presented at scientific meetings for academic audiences.
TRIAL REGISTRATION NUMBER


NCT03992807.",2020,"The decision aid will be implemented among patients with any age-related cataract in Yuexiu District, which is socioeconomically representative of a major metropolitan region in Southern China.","['patients with any age-related cataract in Yuexiu District, which is socioeconomically representative of a major metropolitan region in Southern China', '772 participants', 'patients with age-related cataract in China']","['patient decision aid or a traditional booklet, and they will complete three surveys: (1) baseline assessment before the intervention', 'traditional booklet with standard general information developed by the National Eye Institute to help patients understand cataract, whereas the intervention group receives a patient decision aid that includes not only the standard general information, but also the quantitative risk information on the possible outcomes of cataract surgery as well as value clarification exercise']","['perceived importance of cataract surgery benefits/harms, decision conflict and confidence, anticipated regret and booklet utilisation and acceptability at 2 weeks, and surgical rates and a cost-utility estimate of the decision aid at 1 year']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0205449', 'cui_str': '3'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1955969', 'cui_str': 'National Eye Institute'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0150401', 'cui_str': 'Values clarification'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0439234', 'cui_str': 'year'}]",772.0,0.141142,"The decision aid will be implemented among patients with any age-related cataract in Yuexiu District, which is socioeconomically representative of a major metropolitan region in Southern China.","[{'ForeName': 'Yingfeng', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China zhyfeng@mail.sysu.edu.cn.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Qu', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Chunxiao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Yuxin', 'Initials': 'Y', 'LastName': 'Zhong', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Mingguang', 'Initials': 'M', 'LastName': 'He', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Yizhi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}]",BMJ open,['10.1136/bmjopen-2019-032242']
889,31578572,Beta-blockers in heart failure patients with severe chronic kidney disease-time for a randomized controlled trial?,,2020,,['heart failure patients with severe chronic kidney disease-time'],['Beta-blockers'],[],"[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0330390', 'cui_str': 'Beta (organism)'}]",[],,0.0510105,,"[{'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Department of Medicine, Division of Nephrology, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': 'University of Lorraine, Inserm 1433 CIC-P CHRU de Nancy, Inserm U1116 and FCRIN INI-CRCT, Nancy, France.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz187']
890,32430455,Evaluating the real-world implementation of the Family Nurse Partnership in England: protocol for a data linkage study.,"INTRODUCTION


Almost 20 000 babies are born to teenage mothers each year in England, with poorer outcomes for mothers and babies than among older mothers. A nurse home visitation programme in the USA was found to improve a wide range of outcomes for young mothers and their children. However, a randomised controlled trial in England found no effect on short-term primary outcomes, although cognitive development up to age 2 showed improvement. Our study will use linked routinely collected health, education and social care data to evaluate the real-world effects of the Family Nurse Partnership (FNP) on child outcomes up to age 7, with a focus on identifying whether the FNP works better for particular groups of families, thereby informing programme targeting and resource allocation.
METHODS AND ANALYSIS


We will construct a retrospective cohort of all women aged 13-24 years giving birth in English NHS hospitals between 2010 and 2017, linking information on mothers and children from FNP programme data, Hospital Episodes Statistics and the National Pupil Database. To assess the effectiveness of FNP, we will compare outcomes for eligible mothers ever and never enrolled in FNP, and their children, using two analysis strategies to adjust for measured confounding: propensity score matching and analyses adjusting for maternal characteristics up to enrolment/28 weeks gestation. Outcomes of interest include early childhood development, childhood unplanned hospital admissions for injury or maltreatment-related diagnoses and children in care. Subgroup analyses will determine whether the effect of FNP varied according to maternal characteristics (eg, age and education).
ETHICS AND DISSEMINATION


The Nottingham Research Ethics Committee approved this study. Mothers participating in FNP were supportive of our planned research. Results will inform policy-makers for targeting home visiting programmes. Methodological findings on the accuracy and reliability of cross-sectoral data linkage will be of interest to researchers.",2020,A nurse home visitation programme in the USA was found to improve a wide range of outcomes for young mothers and their children.,"['retrospective cohort of all women aged 13-24 years giving birth in English NHS hospitals between 2010 and 2017, linking information on mothers and children from FNP programme data, Hospital Episodes Statistics and the National Pupil Database', 'young mothers and their children', 'eligible mothers ever and never enrolled in FNP, and their children', 'Mothers participating in FNP were supportive of our planned research']","['FNP', 'Family Nurse Partnership (FNP']","['early childhood development, childhood unplanned hospital admissions for injury or maltreatment-related diagnoses and children in care', 'cognitive development']","[{'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0728735', 'cui_str': 'Child in care'}]",,0.099084,A nurse home visitation programme in the USA was found to improve a wide range of outcomes for young mothers and their children.,"[{'ForeName': 'Francesca L', 'Initials': 'FL', 'LastName': 'Cavallaro', 'Affiliation': 'Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Gilbert', 'Affiliation': 'Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wijlaars', 'Affiliation': 'Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Eilis', 'Initials': 'E', 'LastName': 'Kennedy', 'Affiliation': 'Children, Young Adults and Families Directorate, Tavistock and Portman NHS Foundation Trust, London, UK.'}, {'ForeName': 'Ailsa', 'Initials': 'A', 'LastName': 'Swarbrick', 'Affiliation': 'Family Nurse Partnership National Unit, Tavistock and Portman NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'van der Meulen', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Harron', 'Affiliation': 'Great Ormond Street Institute of Child Health, University College London, London, UK k.harron@ucl.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2020-038530']
891,31448819,In reference to Dexmedetomidine versus propofol at different sedation depths during drug-induced sleep endoscopy: A randomized trial.,,2020,,[],"['Dexmedetomidine', 'propofol']",[],[],"[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]",[],,0.0388472,,"[{'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Cammaroto', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Gobbi', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'De Vito', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Meccariello', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Giannicola', 'Initials': 'G', 'LastName': 'Iannella', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Vicini', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}]",The Laryngoscope,['10.1002/lary.28261']
892,31943598,New brief temperament guidance program for parents of infants: A pilot evaluation.,"PROBLEM


Intensive temperament guidance programs have been successfully utilized to improve caregiver understanding of temperament and teach strategies for appropriately responding to temperament traits. However, the effects of providing brief psychoeducational temperament information to parents have not been previously examined.
METHODS


Mothers of 3-12-month infants (n = 35) participated in an intervention examining the impact of a comprehensive temperament brochure on temperament knowledge, program attitudes, and parent-child interactions.
FINDINGS


Mothers demonstrated increased temperament knowledge and were generally accepting of the program. Behavioral changes in mother-child interactions were observed. Sensitivity increased, and interactions shifted from more parent-directed to more balanced following the intervention. Infant gender functioned as a moderator of intervention effects for two mother-infant interaction dynamics. A significant increase in reciprocity was observed between mothers and boys, largely as a function of significantly lower levels of reciprocity preintervention. Child gender also interacted with directedness, in that interactions became more balanced for girls, but remained more mother-directed with boys. Finally, maternal education functioned as a moderator of tempo, as mothers in the higher education group shifted from slower to moderate tempo following the intervention.
CONCLUSIONS


Promising results suggest the need for continued implementation and evaluation of brief temperament interventions.",2020,"A significant increase in reciprocity was observed between mothers and boys, largely as a function of significantly lower levels of reciprocity preintervention.","['parents of infants', 'Mothers of 3-12-month infants (n\u2009=\u200935']","['New brief temperament guidance program', 'comprehensive temperament brochure on temperament knowledge, program attitudes, and parent-child interactions']","['Behavioral changes', 'temperament knowledge', 'reciprocity']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0174951,"A significant increase in reciprocity was observed between mothers and boys, largely as a function of significantly lower levels of reciprocity preintervention.","[{'ForeName': 'Sydney L', 'Initials': 'SL', 'LastName': 'Iverson', 'Affiliation': 'The Seattle Clinic, Seattle, Washington.'}, {'ForeName': 'Eric E', 'Initials': 'EE', 'LastName': 'Desmarais', 'Affiliation': 'Department of Psychology, Washington State University, Pullman, Washington.'}, {'ForeName': 'Alyssa A', 'Initials': 'AA', 'LastName': 'Neumann', 'Affiliation': 'Department of Psychology, Washington State University, Pullman, Washington.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Gartstein', 'Affiliation': 'Department of Psychology, Washington State University, Pullman, Washington.'}]","Journal of child and adolescent psychiatric nursing : official publication of the Association of Child and Adolescent Psychiatric Nurses, Inc",['10.1111/jcap.12263']
893,20089469,Influence of mandibular residual ridge resorption on objective masticatory measures of lingualized and fully bilateral balanced denture articulation.,"PURPOSE


To assess the influence of mandibular residual ridge resorption (RRR) on objective masticatory measures of two occlusal schemes: lingualized occlusion (LO) and fully bilateral balanced articulation (FBBA).
METHODS


The enrolled patients (n=22) were randomly allocated one set of complete dentures with either LO or FBBA. Maximum occlusal force, masticatory performance (by the MPI), and mandibular movements were measured at 3- and 6-month follow-ups. Mandibular RRR was assessed as the sum of the mandibular bone height at the midline, first premolar region, and least vertical height region, and from the mental foramen to the alveolar crest, measured on panoramic radiographs; the treatment groups were subclassified into severe or moderate RRR subgroups by the value of the sum of individual measurements.
RESULTS


Significant differences were observed in the between-subgroup comparisons (Kruskal-Wallis test) of the MPI (3 months, p=0.01; 6 months, p=0.04) and linear deviation from intercuspal position (anterior-posterior: 6 months, p=0.01; inferior-superior: 3 months, p=0.008; 6 months, p=0.02). The patients with severe RRR in the FBBA group showed a significant decrease in the MPI and increase in linear inferior deviation from intercuspal position at 3 months (post hoc comparison) as well as a significant increase in the linear posterior and inferior deviation from intercuspal position at 6 months.
CONCLUSIONS


LO is the preferable occlusal scheme for patients with severe RRR.",2010,"The patients with severe RRR in the FBBA group showed a significant decrease in the MPI and increase in linear inferior deviation from intercuspal position at 3 months (post hoc comparison) as well as a significant increase in the linear posterior and inferior deviation from intercuspal position at 6 months.
","['enrolled patients (n=22', 'patients with severe RRR', 'lingualized and fully bilateral balanced denture articulation']","['mandibular residual ridge resorption (RRR', 'two occlusal schemes: lingualized occlusion (LO) and fully bilateral balanced articulation (FBBA', 'LO or FBBA']","['Maximum occlusal force, masticatory performance (by the MPI), and mandibular movements', 'linear posterior and inferior deviation', 'Mandibular RRR', 'MPI', 'linear inferior deviation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0011394', 'cui_str': 'Dentures'}]","[{'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0332243', 'cui_str': 'Ridging (qualifier value)'}, {'cui': 'C4039695', 'cui_str': 'Occlusal scheme'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0005654', 'cui_str': 'Occlusal Force'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}]",22.0,0.0244415,"The patients with severe RRR in the FBBA group showed a significant decrease in the MPI and increase in linear inferior deviation from intercuspal position at 3 months (post hoc comparison) as well as a significant increase in the linear posterior and inferior deviation from intercuspal position at 6 months.
","[{'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Matsumaru', 'Affiliation': 'Department of Gnatho-Oral Prosthetic Rehabilitation, Nihon University School of Dentistry at Matsudo, 2-870-1 Sakaecho-Nishi, Matsudo, Chiba 271-8587, Japan. matsumaru.yuichi@nihon-u.ac.jp'}]",Journal of prosthodontic research,['10.1016/j.jpor.2009.11.008']
894,32065831,Effect of Intravenous Interferon β-1a on Death and Days Free From Mechanical Ventilation Among Patients With Moderate to Severe Acute Respiratory Distress Syndrome: A Randomized Clinical Trial.,"Importance


Acute respiratory distress syndrome (ARDS) is associated with high mortality. Interferon (IFN) β-1a may prevent the underlying event of vascular leakage.
Objective


To determine the efficacy and adverse events of IFN-β-1a in patients with moderate to severe ARDS.
Design, Setting, and Participants


Multicenter, randomized, double-blind, parallel-group trial conducted at 74 intensive care units in 8 European countries (December 2015-December 2017) that included 301 adults with moderate to severe ARDS according to the Berlin definition. The radiological and partial pressure of oxygen, arterial (Pao2)/fraction of inspired oxygen (Fio2) criteria for ARDS had to be met within a 24-hour period, and the administration of the first dose of the study drug had to occur within 48 hours of the diagnosis of ARDS. The last patient visit was on March 6, 2018.
Interventions


Patients were randomized to receive an intravenous injection of 10 μg of IFN-β-1a (144 patients) or placebo (152 patients) once daily for 6 days.
Main Outcomes and Measures


The primary outcome was a score combining death and number of ventilator-free days at day 28 (score ranged from -1 for death to 27 if the patient was off ventilator on the first day). There were 16 secondary outcomes, including 28-day mortality, which were tested hierarchically to control type I error.
Results


Among 301 patients who were randomized (mean age, 58 years; 103 women [34.2%]), 296 (98.3%) completed the trial and were included in the primary analysis. At 28 days, the median composite score of death and number of ventilator-free days at day 28 was 10 days (interquartile range, -1 to 20) in the IFN-β-1a group and 8.5 days (interquartile range, 0 to 20) in the placebo group (P = .82). There was no significant difference in 28-day mortality between the IFN-β-1a vs placebo groups (26.4% vs 23.0%; difference, 3.4% [95% CI, -8.1% to 14.8%]; P = .53). Seventy-four patients (25.0%) experienced adverse events considered to be related to treatment during the study (41 patients [28.5%] in the IFN-β-1a group and 33 [21.7%] in the placebo group).
Conclusions and Relevance


Among adults with moderate or severe ARDS, intravenous IFN-β-1a administered for 6 days, compared with placebo, resulted in no significant difference in a composite score that included death and number of ventilator-free days over 28 days. These results do not support the use of IFN-β-1a in the management of ARDS.
Trial Registration


ClinicalTrials.gov Identifier: NCT02622724.",2020,"There was no significant difference in 28-day mortality between the IFN-β-1a vs placebo groups (26.4% vs 23.0%; difference, 3.4% [95% CI, -8.1% to 14.8%]; P = .53).","['adults with moderate or severe ARDS', '301 patients who were randomized (mean age, 58 years; 103 women [34.2%]), 296 (98.3%) completed the trial and were included in the primary analysis', 'Importance\n\n\nAcute respiratory distress syndrome (ARDS', '74 intensive care units in 8 European countries (December 2015-December 2017) that included 301 adults with moderate to severe ARDS according to the Berlin definition', 'Patients With Moderate to Severe Acute Respiratory Distress Syndrome', 'patients with moderate to severe ARDS']","['IFN-β-1a vs placebo', 'placebo', 'Intravenous Interferon β-1a', 'IFN-β-1a', 'intravenous injection of 10 μg of IFN-β-1a', 'Free From Mechanical Ventilation', 'Interferon (IFN) β-1a']","['radiological and partial pressure of oxygen, arterial (Pao2)/fraction of inspired oxygen (Fio2) criteria for ARDS', 'score combining death and number of ventilator-free days', 'median composite score of death and number of ventilator-free days', 'adverse events', 'composite score that included death and number of ventilator-free days', '28-day mortality', 'Death and Days']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0021494', 'cui_str': 'Intravenous Injections'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}]","[{'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",301.0,0.762358,"There was no significant difference in 28-day mortality between the IFN-β-1a vs placebo groups (26.4% vs 23.0%; difference, 3.4% [95% CI, -8.1% to 14.8%]; P = .53).","[{'ForeName': 'V Marco', 'Initials': 'VM', 'LastName': 'Ranieri', 'Affiliation': ""Alma Mater Studiorum-Università di Bologna, Dipartimento di Scienze Mediche e Chirurgiche, Anesthesia and Intensive Care Medicine, Policlinico di Sant'Orsola, Bologna, Italy.""}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Pettilä', 'Affiliation': 'Division of Intensive Care, Department of Anesthesiology, Intensive Care, and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Matti K', 'Initials': 'MK', 'LastName': 'Karvonen', 'Affiliation': 'Faron Pharmaceuticals Ltd, Turku, Finland.'}, {'ForeName': 'Juho', 'Initials': 'J', 'LastName': 'Jalkanen', 'Affiliation': 'Faron Pharmaceuticals Ltd, Turku, Finland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nightingale', 'Affiliation': 'Manchester University NHS Foundation Trust, Wythenshawe Hospital, Manchester, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brealey', 'Affiliation': 'Critical Care, University College London Hospitals, NHS Foundation Trust and National Institute for Health Research Biomedical Research Centre at University College London Hospitals NHS Foundation Trust and University College London, London, United Kingdom.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Mancebo', 'Affiliation': 'Department of Intensive Care, Hospital de la Santa Creu I Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Ricard', 'Initials': 'R', 'LastName': 'Ferrer', 'Affiliation': ""Department of Intensive Care/SODIR Research Group-VHIR Hospital Universitari Vall d'Hebron UCI, Barcelona, Spain.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Mercat', 'Affiliation': ""Médecine Intensive-Réanimation CHU d'Angers, Université d'Angers, Angers, France.""}, {'ForeName': 'Nicolò', 'Initials': 'N', 'LastName': 'Patroniti', 'Affiliation': 'Dipartimento di scienze diagnostiche e integrate, Università degli studi di Genova, Genova, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Quintel', 'Affiliation': 'Anesthesiology and Operative Intensive Care Medicine, Universitätsmedizin Göttingen, Göttingen, Germany.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Vincent', 'Affiliation': 'Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Marjatta', 'Initials': 'M', 'LastName': 'Okkonen', 'Affiliation': 'Division of Intensive Care, Department of Anesthesiology, Intensive Care, and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Ferhat', 'Initials': 'F', 'LastName': 'Meziani', 'Affiliation': 'Université de Strasbourg (UNISTRA), Faculté de Médecine, Hôpitaux universitaires de Strasbourg, Nouvel Hôpital Civil, Service de réanimation, Strasbourg, France.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Bellani', 'Affiliation': 'Azienda Ospedaliera San Gerardo, Milan, Italy.'}, {'ForeName': 'Niall', 'Initials': 'N', 'LastName': 'MacCallum', 'Affiliation': 'Critical Care, University College London Hospitals, NHS Foundation Trust and National Institute for Health Research Biomedical Research Centre at University College London Hospitals NHS Foundation Trust and University College London, London, United Kingdom.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Creteur', 'Affiliation': 'Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kluge', 'Affiliation': 'Department of Intensive Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Artigas-Raventos', 'Affiliation': 'Corporacion Sanitaria Universitaria Parc Tauli CIBER Enfermedades Respiratorias Autonomous University of Barcelona, Sabadell, Spain.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Maksimow', 'Affiliation': 'Faron Pharmaceuticals Ltd, Turku, Finland.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Piippo', 'Affiliation': 'Faron Pharmaceuticals Ltd, Turku, Finland.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Elima', 'Affiliation': 'Medicity research Laboratory, University of Turku, Turku, Finland.'}, {'ForeName': 'Sirpa', 'Initials': 'S', 'LastName': 'Jalkanen', 'Affiliation': 'Medicity research Laboratory, University of Turku, Turku, Finland.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Jalkanen', 'Affiliation': 'Faron Pharmaceuticals Ltd, Turku, Finland.'}, {'ForeName': 'Geoff', 'Initials': 'G', 'LastName': 'Bellingan', 'Affiliation': 'Critical Care, University College London Hospitals, NHS Foundation Trust and National Institute for Health Research Biomedical Research Centre at University College London Hospitals NHS Foundation Trust and University College London, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2019.22525']
895,31455824,"Morphine compared to placebo for procedural pain in preterm infants: safety, efficacy and equipoise.",,2019,,['preterm infants'],"['placebo', 'Morphine']",[],"[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]",[],,0.11121,,"[{'ForeName': 'Omri David', 'Initials': 'OD', 'LastName': 'Soffer', 'Affiliation': ""Division of Newborn Medicine, Boston Children's Hospital, Boston, MA, USA. Omri.soffer@childrens.harvard.edu.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cornelissen', 'Affiliation': ""Division of Pain Medicine, Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Cummings', 'Affiliation': ""Division of Newborn Medicine, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Berde', 'Affiliation': ""Division of Pain Medicine, Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Boston, MA, USA.""}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0476-9']
896,31856954,Postoperative opioid misuse in patients with opioid use disorders maintained on opioid agonist treatment.,"BACKGROUND


Patients recovering from opioid use disorders (OUD) may be prone to relapse and opioid misuse in the postoperative period due to re-exposure to prescription opioids for pain control. This retrospective study analyzed the incidence of confirmed opioid misuse in the postoperative period in patients with OUDs enrolled in an opioid agonist treatment (OAT) program.
METHODS


The study population was US veterans with a diagnosis of OUD who enrolled in the OAT program at VA Maryland Health Care System (Baltimore, Maryland, USA) between 1/1/2000 and 12/31/2016. The patients were excluded if they were enrolled in OAT for less than a year, or if they had surgery within the first 180 days after OAT admission. The surgical group consisted of veterans who had surgery or an invasive procedure during their enrollment in the OAT program. The control (reference) group consisted of enrolled veterans who did not have any invasive procedure. The primary outcome was the first opioid misuse within 365 days after surgery date in the surgical group or a randomly assigned sham surgery date in controls. Opioid misuse was defined as either inappropriate use of opioids detected via urinalysis or admission with a diagnosis of an opioid overdose.
RESULTS


From a total of 1352 patients enrolled in the OAT program, 413 were excluded because they were enrolled for less than a year, and 26 were excluded because they had surgery within the first 180 days after admission to the OAT program. Of the 923 eligible patients, 87 had surgery while enrolled and 836 did not. Using propensity scores, all 87 of the surgical cases were matched to 249 of the control cases. In the matched groups, surgery was positively associated with postoperative opioid misuse (odds ratio (OR) of 1.91, 95% CI 1.05-3.48, p = 0.034) in logistic regression.
CONCLUSION


Among patients with a history of opioid use disorders, the postoperative period was associated with an increased risk of opioid misuse. Moreover, opioid misuse among patients in an opioid agonist treatment program may well be considered a surgical hazard.",2020,"In the matched groups, surgery was positively associated with postoperative opioid misuse (odds ratio (OR) of 1.91, 95% CI 1.05-3.48, p = 0.034) in logistic regression.
","['patients with a history of opioid use disorders', 'patients were excluded if they were enrolled in OAT for less than a year, or if they had surgery within the first 180 days after OAT admission', '923 eligible patients, 87 had surgery while enrolled and 836 did not', 'veterans who had surgery or an invasive procedure during their enrollment in the OAT program', 'enrolled veterans who did not have any invasive procedure', 'Patients recovering from opioid use disorders (OUD', '1352 patients enrolled in the OAT program, 413 were excluded because they were enrolled for less than a year, and 26 were excluded because they had surgery within the first 180\u202fdays after admission to the OAT program', 'patients with OUDs enrolled in an opioid agonist treatment (OAT) program', 'study population was US veterans with a diagnosis of OUD who enrolled in the OAT program at VA Maryland Health Care System (Baltimore, Maryland, USA) between 1/1/2000 and 12/31/2016', 'patients with opioid use disorders maintained on opioid agonist treatment']",[],"['postoperative opioid misuse', 'risk of opioid misuse']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0028753', 'cui_str': 'Oats (substance)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0348025', 'cui_str': 'Open approach - access (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0521108', 'cui_str': 'Recovering from (contextual qualifier) (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}]",[],"[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",1352.0,0.0472194,"In the matched groups, surgery was positively associated with postoperative opioid misuse (odds ratio (OR) of 1.91, 95% CI 1.05-3.48, p = 0.034) in logistic regression.
","[{'ForeName': 'Khodadad', 'Initials': 'K', 'LastName': 'Namiranian', 'Affiliation': 'VA Maryland Health Care System, Baltimore, MD, United States of America; Department of Anesthesiology, University of Maryland, Baltimore, MD, United States of America. Electronic address: Khodadad.namiranian@va.gov.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Siglin', 'Affiliation': 'School of Medicine, University of Maryland, Baltimore, MD, United States of America.'}, {'ForeName': 'John David', 'Initials': 'JD', 'LastName': 'Sorkin', 'Affiliation': 'Baltimore VA Medical Center Geriatric Research, Education and Clinical Center, VA Maryland Health Care System, Baltimore, MD, United States of America; Division of Gerontology and Geriatric Medicine, University of Maryland, Baltimore, MD, United States of America.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Norris', 'Affiliation': 'VA Maryland Health Care System, Baltimore, MD, United States of America; Department of Anesthesiology, University of Maryland, Baltimore, MD, United States of America.'}, {'ForeName': 'Minu', 'Initials': 'M', 'LastName': 'Aghevli', 'Affiliation': 'VA Maryland Health Care System, Baltimore, MD, United States of America.'}, {'ForeName': 'Edward C', 'Initials': 'EC', 'LastName': 'Covington', 'Affiliation': 'Neurological Institute (Emeritus), Cleveland Clinic, Cleveland, OH, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.10.007']
897,19635614,Bazedoxifene/conjugated estrogens (BZA/CE): incidence of uterine bleeding in postmenopausal women.,"OBJECTIVE


To evaluate the effect of bazedoxifene/conjugated estrogens (BZA/CE), a tissue selective estrogen complex, on uterine bleeding in postmenopausal women.
DESIGN


International, multicenter, randomized, double-blind, placebo- and active-controlled, phase III study (Selective estrogen Menopause And Response to Therapy [SMART]-1).
SETTING


Outpatient clinical.
PATIENT(S)


Healthy, postmenopausal women (N = 3,397) aged 40 to 75 years with an intact uterus.
INTERVENTION(S)


Daily oral therapy with BZA 10, 20, or 40 mg, each with CE 0.625 or 0.45 mg, raloxifene 60 mg, or placebo.
MAIN OUTCOME MEASURE(S)


Cumulative amenorrhea profiles and the incidence of bleeding or spotting over 2 years.
RESULT(S)


Treatment with BZA 20 or 40 mg with CE 0.625 or 0.45 mg was associated with rates of cumulative amenorrhea (>83% during cycles 1-13 and >93% during cycles 10-13) and bleeding or spotting that were comparable to those with placebo. Subjects who received BZA 10 mg/CE 0.625 mg experienced slightly lower cumulative amenorrhea rates throughout the study compared with placebo-treated subjects.
CONCLUSION(S)


Postmenopausal women treated with BZA 20 or 40 mg with CE 0.625 or 0.45 mg had high rates of cumulative amenorrhea that were similar to those reported with placebo. This new menopausal therapy may offer a favorable bleeding and tolerability profile.",2009,"Daily oral therapy with BZA 10, 20, or 40 mg, each with CE 0.625 or 0.45 mg, raloxifene 60 mg, or placebo.
","['postmenopausal women', 'Outpatient clinical', 'Healthy, postmenopausal women (N = 3,397) aged 40 to 75 years with an intact uterus']","['bazedoxifene/conjugated estrogens (BZA/CE', 'placebo', 'BZA 10 mg/CE', 'raloxifene 60 mg, or placebo', 'BZA', 'Bazedoxifene/conjugated estrogens (BZA/CE', 'CE']","['rates of cumulative amenorrhea', 'Cumulative amenorrhea profiles and the incidence of bleeding or spotting', 'cumulative amenorrhea rates', 'bleeding or spotting', 'cumulative amenorrhea']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0042149', 'cui_str': 'Womb'}]","[{'cui': 'C2346970', 'cui_str': 'bazedoxifene'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0244404', 'cui_str': 'Raloxifene'}]","[{'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",3397.0,0.355419,"Daily oral therapy with BZA 10, 20, or 40 mg, each with CE 0.625 or 0.45 mg, raloxifene 60 mg, or placebo.
","[{'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Archer', 'Affiliation': 'CONRAD Clinical Research Center, Eastern Virginia Medical School, Norfolk, Virginia. Electronic address: archerdf@evms.edu.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Lewis', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Carr', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Olivier', 'Affiliation': 'Wyeth Research, Collegeville, Pennsylvania.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Pickar', 'Affiliation': 'Wyeth Research, Collegeville, Pennsylvania.'}]",Fertility and sterility,['10.1016/j.fertnstert.2009.05.093']
898,19800061,Early and short follicular gonadotropin-releasing hormone antagonist supplementation improves the meiotic status and competence of retrieved oocytes in in vitro fertilization-embryo transfer cycles.,"OBJECTIVE


To investigate whether early and short follicular administration of GnRH antagonist using the flexible protocol has the potential to improve IVF-ET clinical results.
DESIGN


Prospective, controlled, randomized study.
SETTING


University-affiliated assisted reproductive technology unit.
PATIENT(S)


Fifty-three consecutive infertile women were enrolled to the study and control groups.
INTERVENTION(S)


Both groups were treated with recombinant FSH and the flexible GnRH antagonist protocol. Women in the study group were additionally supplemented with three injections of GnRH antagonist (0.25 mg/d on days 1, 2, and 3 of the menstrual cycle).
MAIN OUTCOME MEASURE(S)


Hormonal milieu, oocyte meiotic status, competence for normal fertilization, cleavage, and clinical pregnancy rate.
RESULT(S)


Both groups had comparable baseline characteristics. The duration of recombinant FSH treatment was significantly longer in the study group as compared with the control group (10.9+/-3.1 and 9.7+/-1.3 days, respectively). The number of follicles>or=14 mm and E2 level on the day of hCG administration, number of retrieved oocytes, and endometrial thickness were similar between the two groups. However, the fertilization rate was significantly higher in the study as compared with the control group (85%+/-16% and 69%+/-24%, respectively). Moreover, the cumulative rate of mature first polar body oocytes was significantly higher in the study group as compared with the control group (93% and 85%, respectively). Concomitantly, day-3 FSH and LH levels after initiation of treatment were significantly lower in the study as compared with the control group (6.1+/-2.4 mIU/mL vs. 7.2+/-1.9 mIU/mL and 2.4+/-1.6 mIU/mL vs. 5.6+/-2.7 mIU/mL, respectively).
CONCLUSION(S)


Early and short follicular GnRH antagonist supplementation using flexible GnRH antagonist treatment improves the meiotic status and competence of retrieved oocytes. It seems that early and short pituitary shutdown has the potential to improve clinical results in IVF-ET GnRH antagonist cycles.",2010,"Moreover, the cumulative rate of mature first polar body oocytes was significantly higher in the study group as compared with the control group (93% and 85%, respectively).","['Fifty-three consecutive infertile women were enrolled to the study and control groups', 'University-affiliated assisted reproductive technology unit']","['gonadotropin-releasing hormone antagonist supplementation', 'GnRH antagonist', 'recombinant FSH', 'flexible GnRH antagonist treatment']","['cumulative rate of mature first polar body oocytes', 'Hormonal milieu, oocyte meiotic status, competence for normal fertilization, cleavage, and clinical pregnancy rate', 'meiotic status and competence of retrieved oocytes', 'number of retrieved oocytes, and endometrial thickness', 'fertilization rate', 'day-3 FSH and LH levels', 'number of follicles>or=14 mm and E2 level', 'duration of recombinant FSH treatment']","[{'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0872104', 'cui_str': 'Assisted Reproductive Technologies'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0522259', 'cui_str': 'Hormone antagonist'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0227883', 'cui_str': 'First polar body (cell)'}, {'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.0468687,"Moreover, the cumulative rate of mature first polar body oocytes was significantly higher in the study group as compared with the control group (93% and 85%, respectively).","[{'ForeName': 'Johnny S', 'Initials': 'JS', 'LastName': 'Younis', 'Affiliation': 'Reproductive Medicine Unit, Department of Obstetrics and Gynecology, Poriya Medical Center, Tiberias, Israel; The Bruce Rappaport Faculty of Medicine, The Technion, Haifa, Israel. Electronic address: jsy@netvision.net.il.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Soltsman', 'Affiliation': 'Reproductive Medicine Unit, Department of Obstetrics and Gynecology, Poriya Medical Center, Tiberias, Israel.'}, {'ForeName': 'Ido', 'Initials': 'I', 'LastName': 'Izhaki', 'Affiliation': 'Department of Evolutionary and Environmental Biology, Haifa University, Haifa, Israel.'}, {'ForeName': 'Orit', 'Initials': 'O', 'LastName': 'Radin', 'Affiliation': 'Reproductive Medicine Unit, Department of Obstetrics and Gynecology, Poriya Medical Center, Tiberias, Israel.'}, {'ForeName': 'Shalom', 'Initials': 'S', 'LastName': 'Bar-Ami', 'Affiliation': 'Reproductive Medicine Unit, Department of Obstetrics and Gynecology, Poriya Medical Center, Tiberias, Israel.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Ben-Ami', 'Affiliation': 'Reproductive Medicine Unit, Department of Obstetrics and Gynecology, Poriya Medical Center, Tiberias, Israel; The Bruce Rappaport Faculty of Medicine, The Technion, Haifa, Israel.'}]",Fertility and sterility,['10.1016/j.fertnstert.2009.08.033']
899,31525257,Effect of Xylocaine spray for analgesia during amniocentesis: a randomized controlled trial.,"OBJECTIVE


To compare the effect of Xylocaine spray on pain score during amniocentesis METHODS: Singleton pregnant women undergoing amniocentesis were recruited. Each participant was randomly assigned into three groups. Group 1 (Xylocaine spray): 1 min before the procedure, 8 puffs (80 mg) of 10% Lidocaine spray were sprayed on abdominal wall: group 2 (placebo): 8 puffs of sterile normal saline were sprayed: and group 3 (control): no spray was used. The participants rated their pain through a 10-cm visual analog scale before, during, and 30 min after amniocentesis. Main outcome of study was difference in pain score among three groups.
RESULTS


A total 570 pregnant women participated; 191 in the Xylocaine group, 193 in placebo group, and 186 in control group. Baseline pain was not different. The median procedural pain score was significantly different (2.3, 3.3, and 2.8 respectively; p 0.001). Post-hoc analysis showed that the procedural pain score in Xylocaine group was significantly lower than placebo or control group (p value <0.001 and 0.02, respectively). However, the pain score 30 min after procedure was not different.
CONCLUSION


Xylocaine spray can significantly decrease pain during amniocentesis, however, the clinical significance is unclear given that the procedure-related discomfort is mild and short-lived.",2019,"The median procedural pain score was significantly different (2.3, 3.3 and 2.8 respectively; p 0.001).","['A total 570 pregnant women participated; 191 in the Xylocaine group, 193 in placebo group, and 186 in control group', 'Singleton pregnant women undergoing amniocentesis were recruited', 'analgesia during amniocentesis']","['placebo', 'Xylocaine spray', 'Xylocaine', 'Lidocaine spray were sprayed on abdominal wall: group 2 (placebo): 8 puffs of sterile normal saline were sprayed: and group 3 (control): no spray']","['pain score', 'procedural pain score', 'median procedural pain score', 'pain', 'Baseline pain', 'pain through a 10-cm visual analog scale']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0699094', 'cui_str': 'Xylocaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0002627', 'cui_str': 'Amniocentesis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0699094', 'cui_str': 'Xylocaine'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0836916', 'cui_str': 'Abdominal Wall'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C1533107', 'cui_str': 'Puffs'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1619712', 'cui_str': 'Pain, Procedural'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",570.0,0.33751,"The median procedural pain score was significantly different (2.3, 3.3 and 2.8 respectively; p 0.001).","[{'ForeName': 'Panupun', 'Initials': 'P', 'LastName': 'Homkrun', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Theera', 'Initials': 'T', 'LastName': 'Tongsong', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Kasemsri', 'Initials': 'K', 'LastName': 'Srisupundit', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}]",Prenatal diagnosis,['10.1002/pd.5559']
900,31902311,"Effect of New Zealand Blackcurrant on Blood Pressure, Cognitive Function and Functional Performance in Older Adults.","New Zealand blackcurrant (NZBC) can increase exercise performance in young adults, potentially by anthocyanin-induced cardiovascular function alterations and increased blood flow, however, effects upon blood pressure, functional exercise performance and cognitive function in older adults is unknown. In a randomized, double-blind, placebo-controlled, cross-over design, 14 older adults (age: 69 ± 4 years, height: 172 ± 9 cm, body mass: 85 ± 12) ingested NZBC extract (600 mg·day -1  CurraNZ™) or placebo (PL, 600 mg microcrystalline cellulose) for 7-days (7-day washout between conditions). On day-7, 2-hours following consumption of the capsules, resting blood pressure, cognitive function (Cambridge neuropsychological test automated battery) and 6-minute walk test performance and were measured. Intake of NZBC caused a decrease ( p  < 0.05) in systolic (PL: 136 ± 14; NZBC: 130 ± 12 mmHg) and diastolic (PL: 84 ± 11; NZBC 78 ± 6 mmHg) blood pressure. There was no effect on 6-minute walk performance or cognitive function variables. Future research should address optimization of intake and examine cardiovascular responses during exercise.",2020,Intake of NZBC caused a decrease ( p  < 0.05) in systolic (PL: 136 ± 14; NZBC: 130 ± 12 mmHg) and diastolic (PL: 84 ± 11; NZBC 78 ± 6 mmHg) blood pressure.,"['14 older adults (age: 69\u2009±\u20094\u2009years, height: 172\u2009±\u20099\u2009cm, body mass: 85\u2009±\u200912) ingested', 'young adults', 'older adults', 'Older Adults']","['New Zealand Blackcurrant', 'New Zealand blackcurrant (NZBC', 'placebo (PL, 600\u2009mg microcrystalline cellulose', 'placebo', 'NZBC extract', 'NZBC']","['exercise performance', 'Blood Pressure, Cognitive Function and Functional Performance', 'resting blood pressure, cognitive function (Cambridge neuropsychological test automated battery) and 6-minute walk test performance', '6-minute walk performance or cognitive function variables']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0453277', 'cui_str': 'Black Currant'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0669247', 'cui_str': 'microcrystalline cellulose'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C3853978'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C4505411', 'cui_str': 'Cambridge Neuropsychological Test Automated Battery'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",,0.194445,Intake of NZBC caused a decrease ( p  < 0.05) in systolic (PL: 136 ± 14; NZBC: 130 ± 12 mmHg) and diastolic (PL: 84 ± 11; NZBC 78 ± 6 mmHg) blood pressure.,"[{'ForeName': 'Matthew David', 'Initials': 'MD', 'LastName': 'Cook', 'Affiliation': 'School of Sport and Exercise Science, University of Worcester, Worcester, United Kingdom.'}, {'ForeName': 'Amber Kaur', 'Initials': 'AK', 'LastName': 'Sandu BSc Hons', 'Affiliation': 'School of Sport and Exercise Science, University of Worcester, Worcester, United Kingdom.'}, {'ForeName': 'Jennifer Patricia', 'Initials': 'JP', 'LastName': 'Joyce PhD', 'Affiliation': 'School of Sport and Exercise Science, University of Worcester, Worcester, United Kingdom.'}]",Journal of nutrition in gerontology and geriatrics,['10.1080/21551197.2019.1707740']
901,32431299,Modification effects of T2DM-susceptible SNPs on the reduction of blood glucose in response to lifestyle interventions.,"In recent years, it has been demonstrated that some susceptible gene loci of type 2 diabetes mellitus (T2DM) are not only associated with the susceptibility risk of T2DM, but also the modifying effects of lifestyle interventions. To further explore the modifying effects of the single nucleotide polymorphism (SNP) on the onset of T2DM and the reduction of blood glucose in response to lifestyle interventions among the high-risk population, we performed a lifestyle intervention study in two Deqing rural communities during the period from June to December in 2017. The intensive lifestyle interventions were conducted among the study subjects of the intervention group while those in the control group only received conventional and general health education. All participants were genotyped by the MassARRY system. This study showed that for SNP rs9502570, fasting blood glucose showed a significantly greater reduction for individuals with CC + CT genotype than those with TT genotype ( P =0.031). In the intervention group, the glycated hemoglobin A1C (HbA1C) decreased by 0.03% for those with CC+CT genotype, while HbA1C increased by 0.27% for those with TT genotype ( P =0.012). The difference in the reduction of fasting blood glucose and HbA1c between the intervention and control groups was also statistically significant between individuals with TT and those with CC+CT genotype. For SNP rs10811661, the reduction of fasting blood glucose was significantly higher in people with TT genotype than those with CC + CT genotype (0.44 mmol/L vs 0.12 mmol/L,  P =0.021). The difference in reduction of fasting blood glucose between the intervention group and control group was also statistically significant between TT and CC+CT genotype ( P <0.001). In summary, the SNP genotypes of both rs9502570 and rs10811661 could modify the effects of lifestyle interventions on reducing fasting blood glucose and HbA1C among the high risk rural population for T2DM. The present study has provided supporting evidence for future development of individualized intervention measures for high-risk population of T2DM.",2020,The difference in the reduction of fasting blood glucose and HbA1c between the intervention and control groups was also statistically significant between individuals with TT and those with CC+CT genotype.,['two Deqing rural communities during the period from June to December in 2017'],"['T2DM-susceptible SNPs', 'single nucleotide polymorphism (SNP', 'control group only received conventional and general health education']","['fasting blood glucose', 'reduction of fasting blood glucose', 'blood glucose', 'SNP rs9502570, fasting blood glucose', 'fasting blood glucose and HbA1c', 'HbA1C', 'glycated hemoglobin A1C (HbA1C', 'fasting blood glucose and HbA1C']","[{'cui': 'C0086944', 'cui_str': 'Rural Communities'}]","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",2.0,0.0109742,The difference in the reduction of fasting blood glucose and HbA1c between the intervention and control groups was also statistically significant between individuals with TT and those with CC+CT genotype.,"[{'ForeName': 'Yu Zhuo', 'Initials': 'YZ', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology, School of Public Health, Key Laboratory of Public Health Safety of Ministry of Education, Key Laboratory of Health Technology Assessment, National Health Commission, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Yi Ming', 'Initials': 'YM', 'LastName': 'Zhang', 'Affiliation': 'Deqing County Center for Disease Prevention and Control, Deqing County 313200, China.'}, {'ForeName': 'Xiao Lian', 'Initials': 'XL', 'LastName': 'Dong', 'Affiliation': 'Deqing County Center for Disease Prevention and Control, Deqing County 313200, China.'}, {'ForeName': 'Xue Cai', 'Initials': 'XC', 'LastName': 'Wang', 'Affiliation': 'Deqing County Center for Disease Prevention and Control, Deqing County 313200, China.'}, {'ForeName': 'Jian Fu', 'Initials': 'JF', 'LastName': 'Zhu', 'Affiliation': 'Deqing County Center for Disease Prevention and Control, Deqing County 313200, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology, School of Public Health, Key Laboratory of Public Health Safety of Ministry of Education, Key Laboratory of Health Technology Assessment, National Health Commission, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': 'Department of Epidemiology, School of Public Health, Key Laboratory of Public Health Safety of Ministry of Education, Key Laboratory of Health Technology Assessment, National Health Commission, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Faculty of Medicine, University of Ottawa, Ottawa K1N6N5, Canada.'}, {'ForeName': 'Qing Wu', 'Initials': 'QW', 'LastName': 'Jiang', 'Affiliation': 'Department of Epidemiology, School of Public Health, Key Laboratory of Public Health Safety of Ministry of Education, Key Laboratory of Health Technology Assessment, National Health Commission, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Chao Wei', 'Initials': 'CW', 'LastName': 'Fu', 'Affiliation': 'Department of Epidemiology, School of Public Health, Key Laboratory of Public Health Safety of Ministry of Education, Key Laboratory of Health Technology Assessment, National Health Commission, Fudan University, Shanghai 200032, China.'}]",Yi chuan = Hereditas,['10.16288/j.yczz.19-304']
902,19782973,Mechanically expanding the zona pellucida of human frozen thawed embryos: a new method of assisted hatching.,"OBJECTIVE


To determine whether a new assisted hatching (AH) method increases the implantation and clinical pregnancy rates of frozen-thawed day-3 (D3) embryos.
DESIGN


Prospective study.
SETTING


A university hospital in vitro fertilization (IVF) program.
PATIENT(S)


Patients who had their first IVF/intracytoplasmic sperm injection (ICSI) cycles between June 1, 2006, and December 31, 2008, with fresh IVF-embryo transfer failures or without fresh embryo transfer.
INTERVENTION(S)


The couples were randomized into thawed embryo transfer after AH versus no AH. In the AH group, the zona pellucida (ZP) of D3 frozen-thawed embryos was expanded by injected hydrostatic pressure after thawing. In the control group, embryos were pierced by ICSI needles without expanding the ZP.
MAIN OUTCOME MEASURE(S)


Clinical pregnancy and implantation rates.
RESULT(S)


The morphologic features of the blastomeres were carefully monitored and recorded. In the AH group, 244 embryos were thawed, and 178 (73.0%) survived; in the control group, 259 embryos were thawed, and 190 (73.4%) survived. Despite the transfer of a similar number of embryos, the AH group resulted in statistically significantly higher implantation and clinical pregnancy rates compared with the no AH group.
CONCLUSION(S)


Mechanically expanding the ZP of frozen-thawed D3 embryos with injected hydrostatic pressure after thawing increases the implantation rate compared with control embryos.",2010,"Despite the transfer of a similar number of embryos, the AH group resulted in statistically significantly higher implantation and clinical pregnancy rates compared with the no AH group.
","['\n\n\nPatients who had their first IVF/intracytoplasmic sperm injection (ICSI) cycles between June 1, 2006, and December 31, 2008, with fresh IVF-embryo transfer failures or without fresh embryo transfer', 'A university hospital in vitro fertilization (IVF) program']","['embryo transfer after AH versus no AH', 'new assisted hatching (AH', 'frozen-thawed day-3 (D3) embryos']","['implantation rate', 'Clinical pregnancy and implantation rates', 'implantation and clinical pregnancy rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo (substance)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}]",244.0,0.0320797,"Despite the transfer of a similar number of embryos, the AH group resulted in statistically significantly higher implantation and clinical pregnancy rates compared with the no AH group.
","[{'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Fang', 'Affiliation': ""Reproductive Medicine Center, First Affiliated Hospital of Sun Yat-Sen University, Guangdong, People's Republic of China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ""Reproductive Medicine Center, First Affiliated Hospital of Sun Yat-Sen University, Guangdong, People's Republic of China. Electronic address: lilitao@gmail.com.""}, {'ForeName': 'Ben-Yu', 'Initials': 'BY', 'LastName': 'Miao', 'Affiliation': ""Reproductive Medicine Center, First Affiliated Hospital of Sun Yat-Sen University, Guangdong, People's Republic of China.""}, {'ForeName': 'Guang-Lun', 'Initials': 'GL', 'LastName': 'Zhuang', 'Affiliation': ""Reproductive Medicine Center, First Affiliated Hospital of Sun Yat-Sen University, Guangdong, People's Republic of China.""}, {'ForeName': 'Canquan', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': ""Reproductive Medicine Center, First Affiliated Hospital of Sun Yat-Sen University, Guangdong, People's Republic of China.""}]",Fertility and sterility,['10.1016/j.fertnstert.2009.08.014']
903,19635613,Endometrial effects of a tissue selective estrogen complex containing bazedoxifene/conjugated estrogens as a menopausal therapy.,"OBJECTIVE


To evaluate the endometrial safety of a tissue selective estrogen complex (TSEC; pairing of a selective estrogen receptor modulator [SERM] with estrogens) composed of bazedoxifene/conjugated estrogens (BZA/CE) in postmenopausal women.
DESIGN


Randomized, double-blind, multicenter, placebo- and active-controlled, phase 3 study (Selective estrogen Menopause And Response to Therapy [SMART]-1).
SETTING


Outpatient clinical.
PATIENT(S)


Healthy, postmenopausal women (n = 3,397) age 40-75 with an intact uterus.
INTERVENTION(S)


Single tablets of BZA (10, 20, or 40 mg) combined with CE (0.625 or 0.45 mg); raloxifene (60 mg); or placebo daily for 2 years.
MAIN OUTCOME MEASURE(S)


Incidence of endometrial hyperplasia at 12 months in the efficacy evaluable population.
RESULT(S)


Treatment with BZA (20 or 40 mg)/CE (0.625 or 0.45 mg) was associated with low rates (<1%) of endometrial hyperplasia that were not significantly different from those reported with placebo over 24 months. Endometrial thickness with BZA (20 or 40 mg)/CE (0.625 or 0.45 mg) was not significantly different from that with placebo.
CONCLUSION(S)


When combined with CE (0.625 mg or 0.45 mg), BZA (20 mg) was the lowest effective dose that prevented endometrial hyperplasia over 2 years of study, creating the possibility for a new, progestin-free menopausal therapy.",2009,"Endometrial thickness with BZA (20 or 40 mg)/CE (0.625 or 0.45 mg) was not significantly different from that with placebo.
","['postmenopausal women', 'Outpatient clinical', 'Healthy, postmenopausal women (n = 3,397) age 40-75 with an intact uterus']","['bazedoxifene/conjugated estrogens (BZA/CE', 'placebo', 'tissue selective estrogen complex (TSEC', 'raloxifene', 'tissue selective estrogen complex containing bazedoxifene/conjugated estrogens', 'BZA', 'CE']","['endometrial hyperplasia', 'Endometrial thickness']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0042149', 'cui_str': 'Womb'}]","[{'cui': 'C2346970', 'cui_str': 'bazedoxifene'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0244404', 'cui_str': 'Raloxifene'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0014938', 'cui_str': 'conjugated estrogens'}]","[{'cui': 'C0014173', 'cui_str': 'Endometrial Hyperplasia'}]",3397.0,0.438224,"Endometrial thickness with BZA (20 or 40 mg)/CE (0.625 or 0.45 mg) was not significantly different from that with placebo.
","[{'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Pickar', 'Affiliation': 'Wyeth Research, Collegeville, Pennsylvania. Electronic address: pickarj@wyeth.com.'}, {'ForeName': 'I-Tien', 'Initials': 'IT', 'LastName': 'Yeh', 'Affiliation': 'University of Texas Health Science Center, San Antonio, Texas.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Bachmann', 'Affiliation': 'Robert Wood Johnson University Hospital, New Brunswick, New Jersey.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Speroff', 'Affiliation': 'Oregon Health and Science University, Portland, Oregon.'}]",Fertility and sterility,['10.1016/j.fertnstert.2009.05.094']
904,19782353,Comparison of the effectiveness of single versus double intrauterine insemination with three different timing regimens.,"OBJECTIVE


To compare double insemination with two different single insemination regimens.
DESIGN


Prospective study.
SETTING


Tertiary education and research hospital.
PATIENT(S)


Four hundred and fifty patients with unexplained infertility, male factor, and ovulatory dysfunction underwent controlled ovarian hyperstimulation with gonadotropin.
INTERVENTION(S)


The patients were divided randomly into three groups: patients in group 1 underwent a single preovulatory intrauterine insemination (IUI) performed 24 hours after hCG administration. Patients in group 2 underwent two IUIs performed 12 and 36 hours after hCG administration. Patients in group 3 underwent a single periovulatory IUI performed 36 hours after hCG administration.
MAIN OUTCOME MEASURE(S)


Pregnancy rate.
RESULT(S)


The total pregnancy rate per patient was 14.2 % (64 pregnancies in 450 patients). Group 1 had 17 pregnancies (11.3%), while groups 2 and 3 had 21 (14.0%) and 26 (17.2%) pregnancies, respectively. The difference between the three groups in regard to pregnancy rates was statistically not significant.
CONCLUSION(S)


Despite the 36th hour being the preferred timing for IUI, there was no difference regarding pregnancy rates between single 24th hour and double 12th- and 36th-hour inseminations. This finding suggests that the 24th-hour IUI might be preferred in demanding situations.",2010,"The difference between the three groups in regard to pregnancy rates was statistically not significant.
","['Four hundred and fifty patients with unexplained infertility, male factor, and ovulatory dysfunction underwent controlled ovarian hyperstimulation with gonadotropin', 'Tertiary education and research hospital']",['single preovulatory intrauterine insemination (IUI'],"['Pregnancy rate', 'pregnancy rates', 'total pregnancy rate']","[{'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory (finding)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C3160882', 'cui_str': 'Controlled ovarian hyperstimulation'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0035168'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination (procedure)'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",450.0,0.0551588,"The difference between the three groups in regard to pregnancy rates was statistically not significant.
","[{'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Tonguc', 'Affiliation': ""Zekai Tahir Burak Women's Health Research and Education Hospital, Department of Reproductive Endocrinology, Baskent University School of Medicine, Ankara, Turkey. Electronic address: esratonguc@yahoo.com.""}, {'ForeName': 'Turgut', 'Initials': 'T', 'LastName': 'Var', 'Affiliation': ""Zekai Tahir Burak Women's Health Research and Education Hospital, Department of Reproductive Endocrinology, Baskent University School of Medicine, Ankara, Turkey.""}, {'ForeName': 'Gogsen', 'Initials': 'G', 'LastName': 'Onalan', 'Affiliation': 'Department of Obstetrics and Gynecology, Baskent University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Sibel', 'Initials': 'S', 'LastName': 'Altinbas', 'Affiliation': ""Zekai Tahir Burak Women's Health Research and Education Hospital, Department of Reproductive Endocrinology, Baskent University School of Medicine, Ankara, Turkey.""}, {'ForeName': 'Aytekin', 'Initials': 'A', 'LastName': 'Tokmak', 'Affiliation': ""Zekai Tahir Burak Women's Health Research and Education Hospital, Department of Reproductive Endocrinology, Baskent University School of Medicine, Ankara, Turkey.""}, {'ForeName': 'Nafiye', 'Initials': 'N', 'LastName': 'Karakaş', 'Affiliation': ""Zekai Tahir Burak Women's Health Research and Education Hospital, Department of Reproductive Endocrinology, Baskent University School of Medicine, Ankara, Turkey.""}, {'ForeName': 'Cavidan', 'Initials': 'C', 'LastName': 'Gulerman', 'Affiliation': ""Zekai Tahir Burak Women's Health Research and Education Hospital, Department of Reproductive Endocrinology, Baskent University School of Medicine, Ankara, Turkey.""}]",Fertility and sterility,['10.1016/j.fertnstert.2009.08.030']
905,19732888,Letrozole versus combined metformin and clomiphene citrate for ovulation induction in clomiphene-resistant women with polycystic ovary syndrome: a randomized controlled trial.,"OBJECTIVE


To compare the effect of letrozole with combined metformin and clomiphene citrate (CC) for ovulation induction in CC-resistant women with polycystic ovary syndrome (PCOS).
DESIGN


A randomized controlled trial.
SETTING


University teaching hospital and a private practice setting.
PATIENT(S)


Two hundred fifty anovulatory women (582 cycles) with CC-resistant PCOS.
INTERVENTION(S)


Patients received 2.5 mg of letrozole daily (123 patients, 285 cycles) or combined metformin-CC (127 patients, 297 cycles) for three treatment cycles.
MAIN OUTCOME MEASURE(S)


Ovulation rate, number of follicles, serum E(2), serum P, endometrial thickness, pregnancy, and miscarriage rates.
RESULT(S)


Ovulation occurred in 185/285 cycles (64.9%) in the letrozole group versus 207/297 cycles (69.6%) in the combined metformin-CC group, without statistically significant difference. The total number of follicles was significantly more in the combined metformin-CC group (4.4+/-0.4 vs. 6.8+/-0.3). A nonsignificant increase in endometrial thickness on the day of hCG administration was observed in the letrozole group (9.5+/-0.2 mm vs. 9.1+/-0.1 mm). No statistically significant difference regarding the pregnancy rate (PR) was observed between both groups (14.7% vs. 14.4%).
CONCLUSION(S)


Letrozole and combined metformin-CC are equally effective for inducing ovulation and achieving pregnancy in patients with CC-resistant PCOS.",2010,"No statistically significant difference regarding the pregnancy rate (PR) was observed between both groups (14.7% vs. 14.4%).
","['CC-resistant women with polycystic ovary syndrome (PCOS', 'University teaching hospital and a private practice setting', 'clomiphene-resistant women with polycystic ovary syndrome', 'Two hundred fifty anovulatory women (582 cycles) with CC-resistant PCOS', 'patients with CC-resistant PCOS']","['letrozole with combined metformin and clomiphene citrate (CC', 'Letrozole', 'Letrozole and combined metformin-CC', 'letrozole', 'metformin and clomiphene citrate', 'combined metformin-CC']","['endometrial thickness', 'Ovulation rate, number of follicles, serum E(2), serum P, endometrial thickness, pregnancy, and miscarriage rates', 'Ovulation', 'pregnancy rate (PR', 'total number of follicles']","[{'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0009008', 'cui_str': 'Clomiphene'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0429468', 'cui_str': 'Anovulatory (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.127884,"No statistically significant difference regarding the pregnancy rate (PR) was observed between both groups (14.7% vs. 14.4%).
","[{'ForeName': 'Hatem', 'Initials': 'H', 'LastName': 'Abu Hashim', 'Affiliation': 'Departments of Obstetrics & Gynecology, Mansoura University, Mansoura, Egypt. Electronic address: hatem_ah@hotmail.com.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Shokeir', 'Affiliation': 'Departments of Obstetrics & Gynecology, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Badawy', 'Affiliation': 'Departments of Obstetrics & Gynecology, Mansoura University, Mansoura, Egypt.'}]",Fertility and sterility,['10.1016/j.fertnstert.2009.07.985']
906,19635615,Evaluation of bazedoxifene/conjugated estrogens for the treatment of menopausal symptoms and effects on metabolic parameters and overall safety profile.,"OBJECTIVE


To evaluate the effects of a tissue-selective estrogen complex (TSEC) composed of bazedoxifene/conjugated estrogens (BZA/CE) on menopausal symptoms, metabolic parameters, and overall safety.
DESIGN


Multicenter, double-blind, placebo- and active-controlled phase 3 trial (Selective estrogens, Menopause, And Response to Therapy [SMART]-1).
SETTING


Outpatient clinical.
PATIENT(S)


Healthy, postmenopausal women (n = 3,397) age 40 to 75 with an intact uterus.
INTERVENTION(S)


Single tablets of BZA (10, 20, or 40 mg), each with CE (0.625 or 0.45 mg); raloxifene 60 mg; or placebo taken daily for 2 years.
MAIN OUTCOME MEASURE(S)


Hot flushes, breast pain, vaginal atrophy, metabolic parameters, and adverse events.
RESULT(S)


BZA (20 mg)/CE (0.625 or 0.45 mg) significantly reduced the frequency and severity of hot flushes and improved measures of vaginal atrophy compared with placebo. At week 12, the daily number of hot flushes decreased by 51.7% to 85.7% with all BZA/CE doses vs. 17.1% for placebo. BZA/CE improved lipid parameters and homocysteine levels, did not significantly change carbohydrate metabolism, and had only minor effects on some coagulation parameters. The incidences of breast pain and adverse events were similar between BZA/CE and placebo.
CONCLUSION


The TSEC composed of BZA (20 mg)/CE (0.625 or 0.45 mg) is an effective and safe treatment for menopausal symptoms.",2009,"BZA/CE improved lipid parameters and homocysteine levels, did not significantly change carbohydrate metabolism, and had only minor effects on some coagulation parameters.","['Outpatient clinical', 'Healthy, postmenopausal women (n = 3,397) age 40 to 75 with an intact uterus']","['bazedoxifene/conjugated estrogens (BZA/CE', 'placebo', 'bazedoxifene/conjugated estrogens', 'raloxifene', 'BZA/CE', 'BZA', 'tissue-selective estrogen complex (TSEC', 'CE']","['Hot flushes, breast pain, vaginal atrophy, metabolic parameters, and adverse events', 'metabolic parameters and overall safety profile', 'incidences of breast pain and adverse events', 'vaginal atrophy', 'lipid parameters and homocysteine levels', 'daily number of hot flushes', 'menopausal symptoms, metabolic parameters, and overall safety', 'frequency and severity of hot flushes']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0042149', 'cui_str': 'Womb'}]","[{'cui': 'C2346970', 'cui_str': 'bazedoxifene'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0014938', 'cui_str': 'conjugated estrogens'}, {'cui': 'C0244404', 'cui_str': 'Raloxifene'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}]","[{'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0024902', 'cui_str': 'Mammalgia'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C2242817', 'cui_str': 'Homocysteine measurement (procedure)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",3397.0,0.170067,"BZA/CE improved lipid parameters and homocysteine levels, did not significantly change carbohydrate metabolism, and had only minor effects on some coagulation parameters.","[{'ForeName': 'Rogerio A', 'Initials': 'RA', 'LastName': 'Lobo', 'Affiliation': 'Columbia University Medical Center, New York, New York. Electronic address: ral35@columbia.edu.'}, {'ForeName': 'JoAnn V', 'Initials': 'JV', 'LastName': 'Pinkerton', 'Affiliation': 'University of Virginia Health System, Charlottesville, Virginia.'}, {'ForeName': 'Margery L S', 'Initials': 'MLS', 'LastName': 'Gass', 'Affiliation': 'University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Maxine H', 'Initials': 'MH', 'LastName': 'Dorin', 'Affiliation': 'University of New Mexico Medical School, Albuquerque, New Mexico.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Ronkin', 'Affiliation': 'Wyeth Research, Collegeville, Pennsylvania.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Pickar', 'Affiliation': 'Wyeth Research, Collegeville, Pennsylvania.'}, {'ForeName': 'Ginger', 'Initials': 'G', 'LastName': 'Constantine', 'Affiliation': 'Wyeth Research, Collegeville, Pennsylvania.'}]",Fertility and sterility,['10.1016/j.fertnstert.2009.03.113']
907,19635616,Efficacy of tissue-selective estrogen complex of bazedoxifene/conjugated estrogens for osteoporosis prevention in at-risk postmenopausal women.,"OBJECTIVE


To evaluate the efficacy of the tissue-selective estrogen complex, bazedoxifene/conjugated estrogens (BZA/CE), for postmenopausal osteoporosis prevention.
DESIGN


Multicenter, randomized, double-blind, placebo- and active-controlled, phase 3 trial (Selective estrogen Menopause And Response to Therapy [SMART]-1).
SETTING


Outpatient clinical study.
PATIENT(S)


Women (n = 3,397) more than 5 years and 1-5 years postmenopause were enrolled in the Osteoporosis Prevention I and II Substudies, respectively.
INTERVENTION(S)


Single tablets of BZA (10, 20, or 40 mg) each with CE (0.625 or 0.45 mg), raloxifene (60 mg), or a placebo taken daily for 2 years.
MAIN OUTCOME MEASURE(S)


The primary outcome for both substudies was change in bone mineral density of the lumbar spine; bone mineral density was also measured at the hip.
RESULT(S)


In both substudies, bone mineral density increased significantly more with all BZA/CE doses compared with placebo at the lumbar spine and total hip, and for most BZA/CE doses compared with raloxifene at the lumbar spine. Osteocalcin and N-telopeptide significantly decreased with all BZA/CE doses vs. placebo and most BZA/CE doses vs. raloxifene.
CONCLUSION(S)


BZA/CE combinations decreased bone turnover and bone loss in postmenopausal women at increased risk for osteoporosis.",2009,"Osteocalcin and N-telopeptide significantly decreased with all BZA/CE doses vs. placebo and most BZA/CE doses vs. raloxifene.
","['Outpatient clinical study', 'Women (n = 3,397) more than 5 years and 1-5 years postmenopause were enrolled in the Osteoporosis Prevention I and II Substudies, respectively', 'at-risk postmenopausal women', 'postmenopausal women at increased risk for osteoporosis']","['tissue-selective estrogen complex, bazedoxifene/conjugated estrogens (BZA/CE', 'placebo', 'raloxifene', 'BZA/CE', 'BZA', 'tissue-selective estrogen complex of bazedoxifene/conjugated estrogens', 'CE']","['bone mineral density of the lumbar spine; bone mineral density', 'bone turnover and bone loss', 'bone mineral density', 'Osteocalcin and N-telopeptide']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0206159', 'cui_str': 'Post-menopausal Period'}, {'cui': 'C3650929', 'cui_str': 'Prevention of osteoporosis (procedure)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C2346970', 'cui_str': 'bazedoxifene'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0244404', 'cui_str': 'Raloxifene'}, {'cui': 'C0014938', 'cui_str': 'conjugated estrogens'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C1868706', 'cui_str': 'N-telopeptide'}]",,0.210632,"Osteocalcin and N-telopeptide significantly decreased with all BZA/CE doses vs. placebo and most BZA/CE doses vs. raloxifene.
","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lindsay', 'Affiliation': 'Department of Medicine, Helen Hayes Hospital, West Haverstraw, New York, New York, and Columbia University, New York, New York. Electronic address: lindsayr@helenhayeshosp.org.'}, {'ForeName': 'J Christopher', 'Initials': 'JC', 'LastName': 'Gallagher', 'Affiliation': 'Bone Metabolism Unit, Creighton University School of Medicine, Omaha, Nebraska.'}, {'ForeName': 'Risa', 'Initials': 'R', 'LastName': 'Kagan', 'Affiliation': 'Foundation for Osteoporosis Research and Education, Oakland, California and East Bay Physicians Medical Group, Berkeley, California.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Pickar', 'Affiliation': 'Clinical Research and Development, Wyeth Research, Philadelphia, Pennsylvania.'}, {'ForeName': 'Ginger', 'Initials': 'G', 'LastName': 'Constantine', 'Affiliation': 'Clinical Research and Development, Wyeth Research, Philadelphia, Pennsylvania.'}]",Fertility and sterility,['10.1016/j.fertnstert.2009.02.093']
908,18930200,Stimulation of endometrium embryo transfer can improve implantation and pregnancy rates for patients undergoing assisted reproductive technology for the first time with a high-grade blastocyst.,"OBJECTIVE


To evaluate whether stimulation of endometrium embryo transfer (SEET) can improve implantation rate and pregnancy rate (PR) for patients undergoing assisted reproductive technology (ART) for the first time by injecting embryo culture supernatant into the uterus before blastocyst transfer (BT).
DESIGN


Randomized, controlled trial.
SETTING


Private in vitro fertilization clinic.
PATIENT(S)


Forty-eight women in the BT group, 48 women in the stimulation group who had culture medium injected into the uterus before BT, and 48 women in the SEET group.
INTERVENTION(S)


Injection of embryo culture supernatant and injection of culture medium.
MAIN OUTCOME MEASURE(S)


Implantation rates and PRs.
RESULT(S)


Odds ratios of successful implantation rate for stimulation and SEET in patients with high-grade blastocysts, having BT as reference, were 2.58 and 6.46 without adjustment, and 5.91 and 9.20 after adjusting for basal FSH levels and period of infertility. Odds ratios of clinical pregnancies were 2.47 and 4.32 without adjustment, and 4.46 and 5.10 with adjustment, respectively. In groups with low-grade blastocysts, such tendencies were not observed.
CONCLUSION(S)


The SEET may be an effective method for increasing implantation rate and PR for first-time ART patients who have a high-grade blastocyst.",2009,"CONCLUSION(S)


The SEET may be an effective method for increasing implantation rate and PR for first-time ART patients who have a high-grade blastocyst.","['Private in vitro fertilization clinic', 'Forty-eight women in the BT group, 48 women in the stimulation group who had culture medium injected into the uterus before BT, and 48 women in the SEET group', 'patients undergoing assisted reproductive technology (ART) for the first time by injecting embryo culture supernatant into the uterus before blastocyst transfer (BT', 'patients undergoing assisted reproductive technology for the first time with a high-grade blastocyst']","['endometrium embryo transfer', 'endometrium embryo transfer (SEET', 'embryo culture supernatant and injection of culture medium']","['implantation rate and pregnancy rate (PR', 'Odds ratios of clinical pregnancies', 'Implantation rates and PRs', 'implantation and pregnancy rates', 'implantation rate and PR']","[{'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0010454', 'cui_str': 'Culture Media'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0042149', 'cui_str': 'Womb'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0872104', 'cui_str': 'Assisted Reproductive Technologies'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0936221', 'cui_str': 'Blastocyst Transfer'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0005705', 'cui_str': 'Embryo stage 3 structure'}]","[{'cui': 'C0014180', 'cui_str': 'Endometrium'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0010454', 'cui_str': 'Culture Media'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]",48.0,0.0655868,"CONCLUSION(S)


The SEET may be an effective method for increasing implantation rate and PR for first-time ART patients who have a high-grade blastocyst.","[{'ForeName': 'Sakae', 'Initials': 'S', 'LastName': 'Goto', 'Affiliation': ""Hanabusa Women's Clinic, Kobe, Japan. Electronic address: gotoms@tcn.zaq.ne.jp.""}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kadowaki', 'Affiliation': 'Department of Health Science, Shiga University of Medical Science, Otsu, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Hashimoto', 'Affiliation': ""Hanabusa Women's Clinic, Kobe, Japan.""}, {'ForeName': 'Shoji', 'Initials': 'S', 'LastName': 'Kokeguchi', 'Affiliation': ""Hanabusa Women's Clinic, Kobe, Japan.""}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Shiotani', 'Affiliation': ""Hanabusa Women's Clinic, Kobe, Japan.""}]",Fertility and sterility,['10.1016/j.fertnstert.2008.08.076']
909,19394002,A prospective randomized placebo-controlled study of the effect of acupuncture in infertile patients with severe oligoasthenozoospermia.,"In this first prospective, randomized, single-blind, placebo-controlled study, 28 infertile patients with severe oligoasthenozoospermia received acupuncture according to the principles of traditional Chinese medicine (TCM) and 29 infertile patients received placebo acupuncture. A significantly higher percentage of motile sperm (World Health Organization categories A-C), but no effect on sperm concentration, was found after acupuncture compared with placebo acupuncture.",2009,"A significantly higher percentage of motile sperm (World Health Organization categories A-C), but no effect on sperm concentration, was found after acupuncture compared with placebo acupuncture.","['28 infertile patients with severe oligoasthenozoospermia received', 'infertile patients with severe oligoasthenozoospermia', '29 infertile patients received']","['acupuncture', 'traditional Chinese medicine (TCM', 'placebo', 'placebo acupuncture']","['sperm concentration', 'motile sperm']","[{'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3164407', 'cui_str': 'Oligoasthenozoospermia (finding)'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1261167', 'cui_str': 'Sperm concentration'}, {'cui': 'C4301985', 'cui_str': 'Motile spermatozoa'}]",28.0,0.36928,"A significantly higher percentage of motile sperm (World Health Organization categories A-C), but no effect on sperm concentration, was found after acupuncture compared with placebo acupuncture.","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Dieterle', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Witten/Herdecke, Dortmund, Germany; Infertility Center Dortmund, Dortmund, Germany. Electronic address: dieterle@ivf-dortmund.de.'}, {'ForeName': 'Chunfang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Witten/Herdecke, Dortmund, Germany; Department of Rehabilitation Medicine, Tongji Medical College, Wuhan, People's Republic of China.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Greb', 'Affiliation': 'Infertility Center Dortmund, Dortmund, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Bartzsch', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Witten/Herdecke, Dortmund, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hatzmann', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Witten/Herdecke, Dortmund, Germany.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': ""Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Witten/Herdecke, Dortmund, Germany; Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, People's Republic of China.""}]",Fertility and sterility,['10.1016/j.fertnstert.2009.02.041']
910,19261275,Intrauterine insemination with or without mild ovarian stimulation in couples with male subfertility due to oligo/astheno- and/or teratozoospermia or antisperm antibodies: a prospective cross-over trial.,"Seventy-three couples with male subfertility, which was due to oligo/astheno- and/or teratozoospermia (n = 63) or antisperm antibodies (n = 10), were randomly assigned to sequential timed natural intercourse, intrauterine insemination (IUI) and IUI + mild ovarian hyperstimulation. From the analysis of 384 observed cycles, IUI was shown to be effective in oligo/asthenozoospermia without severe teratozoospermia, when it was associated with moderate multifollicular induction, and in male immunologic subfertility, IUI was highly effective in nonstimulated cycles also.",2009,"From the analysis of 384 observed cycles, IUI was shown to be effective in oligo/asthenozoospermia without severe teratozoospermia, when it was associated with moderate multifollicular induction, and in male immunologic subfertility, IUI was highly effective in nonstimulated cycles also.","['couples with male subfertility due to oligo/astheno', 'Seventy-three couples with male subfertility, which was due to oligo/astheno', 'n = 63) or antisperm antibodies (n = 10']","['sequential timed natural intercourse, intrauterine insemination (IUI) and IUI + mild ovarian hyperstimulation', 'teratozoospermia or antisperm antibodies', 'and/or teratozoospermia', 'Intrauterine insemination with or without mild ovarian stimulation']",[],"[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0848676', 'cui_str': 'Sub-Fertility, Male'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1137305', 'cui_str': 'oligo(caprolactone)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination (procedure)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0549383', 'cui_str': 'Hyperstimulation of ovaries (disorder)'}, {'cui': 'C0403824', 'cui_str': 'Abnormal Spermatozoa'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}]",[],,0.0452318,"From the analysis of 384 observed cycles, IUI was shown to be effective in oligo/asthenozoospermia without severe teratozoospermia, when it was associated with moderate multifollicular induction, and in male immunologic subfertility, IUI was highly effective in nonstimulated cycles also.","[{'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Francavilla', 'Affiliation': ""Andrologic Unit, Department of Internal Medicine, University of L'Aquila, L'Aquila, Italy. Electronic address: francavi@cc.univaq.it.""}, {'ForeName': 'Filomena', 'Initials': 'F', 'LastName': 'Sciarretta', 'Affiliation': ""Andrologic Unit, Department of Internal Medicine, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Sorgentone', 'Affiliation': ""Andrologic Unit, Department of Internal Medicine, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Necozione', 'Affiliation': ""Epidemiology, Department of Internal Medicine, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Santucci', 'Affiliation': ""Andrologic Unit, Department of Internal Medicine, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Arcangelo', 'Initials': 'A', 'LastName': 'Barbonetti', 'Affiliation': ""Andrologic Unit, Department of Internal Medicine, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Francavilla', 'Affiliation': ""Andrologic Unit, Department of Internal Medicine, University of L'Aquila, L'Aquila, Italy.""}]",Fertility and sterility,['10.1016/j.fertnstert.2009.01.112']
911,32430771,Hypopharyngeal packing during adenotonsillectomy by cold dissection in children: a randomized controlled trial.,"PURPOSE


Nausea and vomiting occur in up to 70% of children after adenotonsillectomy, ingested blood during procedure being one of the reasons for emesis. Hypopharyngeal packing (HP) is a common practice among otolaryngologists to prevent blood from being swallowed, but studies in nasal surgeries in adults failed to show efficacy of this technique in reducing postoperative nausea and vomiting (PONV). There are no studies evaluating the effect of HP in adenotonsillectomy in children. The aim of this study is to evaluate the efficacy HP during adenotonsillectomy in children in the prevention of PONV.
METHODS


This is a randomized, double-blinded, controlled trial. Children aged 4-16 years, scheduled for adenotonsillectomy due to sleep-disordered breathing were enrolled in Hospital da Criança Santo Antônio (Brazil). 192 participants were screened, while 129 were enrolled and completed follow-up for primary outcome. Patients were randomized in a consecutive manner to receive HP or not during adenotonsillectomy. PONV occurrence was assessed in the first 24 h after surgery in HP and control group and relative risk with 95% confidence interval was calculated.
RESULTS


There were 129 patients randomized, 64 in the HP and 65 in the control group. Female were 40.3% and mean ± SD age was 7.3 ± 2.9. Baseline characteristics and surgery variables were distributed similarly between the groups. Incidence of PONV was 20.3% in the HP and 23.1% in the control group. The relative risk for PONV was 0.88 (95% CI 0.46-1.70).
CONCLUSION


Our results suggest that there is no benefit of HP during adenotonsillectomy in children for the prevention of PONV.
TRIAL REGISTRATION


Brazilian Register of Randomized Trials (REBEC) identifier: RBR-3zjn27; Universal Trial Number U1111-1197-7461.",2020,The relative risk for PONV was 0.88,"['children', '129 patients randomized, 64 in the HP and 65 in the control group', 'children in the prevention of PONV', '192 participants were screened, while 129 were enrolled and completed follow-up for primary outcome', 'Female were 40.3% and mean\u2009±\u2009SD age was 7.3\u2009±\u20092.9', 'Children aged 4-16\xa0years, scheduled for adenotonsillectomy due to sleep-disordered breathing were enrolled in Hospital da Criança Santo Antônio (Brazil']","['HP or not during adenotonsillectomy', 'HP', 'Hypopharyngeal packing during adenotonsillectomy by cold dissection', 'adenotonsillectomy', 'Hypopharyngeal packing (HP']","['relative risk for PONV', 'PONV occurrence', 'postoperative nausea and vomiting (PONV', 'efficacy HP', 'Incidence of PONV']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020629', 'cui_str': 'Hypopharyngeal structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0020629', 'cui_str': 'Hypopharyngeal structure'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}]","[{'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0020629', 'cui_str': 'Hypopharyngeal structure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",192.0,0.550873,The relative risk for PONV was 0.88,"[{'ForeName': 'Luciana Pimentel', 'Initials': 'LP', 'LastName': 'Oppermann', 'Affiliation': 'Department of Pediatric Otolaryngology of Hospital da Criança Santo Antônio/Postgraduate Program in Pediatrics, Irmandade da Santa Casa de Misericórdia de Porto Alegre/Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil. luopp24@hotmail.com.'}, {'ForeName': 'José Faibes', 'Initials': 'JF', 'LastName': 'Lubianca Neto', 'Affiliation': 'Department of Pediatric Otolaryngology of Hospital da Criança Santo Antônio/Postgraduate Program in Pediatrics, Irmandade da Santa Casa de Misericórdia de Porto Alegre/Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Renata Loss', 'Initials': 'RL', 'LastName': 'Drummond', 'Affiliation': 'Department of Pediatric Otolaryngology of Hospital da Criança Santo Antônio, Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Sérgio Luis', 'Initials': 'SL', 'LastName': 'Amantéa', 'Affiliation': 'Department of Pediatrics of Hospital da Criança Santo Antônio/Postgraduate Program in Pediatrics, Irmandade da Santa Casa de Misericórdia de Porto Alegre/Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Mariele', 'Initials': 'M', 'LastName': 'Bressan', 'Affiliation': 'Department of Otolaryngology, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Eduardo Esteves de Alcântara Marques', 'Initials': 'EEAM', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Otolaryngology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Maira Isis Dos Santos', 'Initials': 'MIDS', 'LastName': 'Stangler', 'Affiliation': 'Department of Corporate Education in Nursing of Hospital da Criança Santo Antônio/Postgraduate Program in Pediatrics, Irmandade da Santa Casa de Misericórdia de Porto Alegre/Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06032-5']
912,31638647,With our powers combined: Does the pooled analysis of existing randomized data regarding treatment of atrial fibrillation in heart failure settle the case for catheter ablation?,,2020,,[],[],[],[],[],[],,0.0328373,,"[{'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Honarbakhsh', 'Affiliation': 'The Barts Heart Centre, Barts Health NHS Trust, Department of Arrhythmia Management, London, UK.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Prabhu', 'Affiliation': 'The Alfred Hospital and Baker Heart and Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Ross J', 'Initials': 'RJ', 'LastName': 'Hunter', 'Affiliation': 'The Barts Heart Centre, Barts Health NHS Trust, Department of Arrhythmia Management, London, UK.'}]",European heart journal,['10.1093/eurheartj/ehz704']
913,19540477,"Intercourse compliance, ovulation, and treatment success in the National Institute of Child Health and Human Development-Reproductive Medicine Network's Pregnancy in Polycystic Ovary Syndrome (PPCOS) Trial.","OBJECTIVE


To investigate the relationship among intercourse compliance, ovulation, and the occurrence of pregnancy in the Reproductive Medicine Network's Pregnancy in Polycystic Ovary Syndrome (RMNPPCOS) Trial.
DESIGN


Post hoc data analysis of subjects in the Reproductive Medicine Network PPCOS Trial.
SETTING


Academic medical centers.
INTERVENTION(S)


None.
PATIENT(S)


Six hundred twenty-six infertile women with polycystic ovary syndrome with a mean age of 28.1+/-4 years and mean body mass index of 35.2+/-8.7 kg/m2.
MAIN OUTCOME MEASURE(S)


Intercourse compliance, ovulation, and pregnancy.
RESULT(S)


Data on 2925 cycles were included in the analysis, of which 1340 were ovulatory cycles and 1585 were nonovulatory cycles. The rates of intercourse compliance in the PPCOS trial were similar across all treatment groups at all cycles except cycle 4. Among cycles with known ovulation status, 81.2% of patients were compliant with intercourse instructions. Patients were more intercourse compliant in those cycles during which ovulation occurred (83.2% vs. 79.4%). With regard to ovulatory cycles, there was no difference in the occurrence of pregnancy when comparing intercourse compliant versus intercourse noncompliant cycles.
CONCLUSION(S)


Intercourse compliance was not associated with the occurrence of pregnancy in ovulatory cycles in the PPCOS Trial. The occurrence of ovulation still remains a critical predictor for the occurrence of pregnancy.",2010,"With regard to ovulatory cycles, there was no difference in the occurrence of pregnancy when comparing intercourse compliant versus intercourse noncompliant cycles.
","['Polycystic Ovary Syndrome (RMNPPCOS) Trial', 'subjects in the Reproductive Medicine Network PPCOS Trial', '2925 cycles were included in the analysis, of which 1340 were ovulatory cycles and 1585 were nonovulatory cycles', 'Academic medical centers', '\n\n\nSix hundred twenty-six infertile women with polycystic ovary syndrome with a mean age of 28.1+/-4 years and mean body mass index of 35.2+/-8.7 kg/m2']",[],"['Intercourse compliance', 'rates of intercourse compliance', 'Intercourse compliance, ovulation, and pregnancy', 'Intercourse compliance, ovulation, and treatment success', 'occurrence of pregnancy']","[{'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0242668', 'cui_str': 'Reproductive Medicine'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory (finding)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]",[],"[{'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",626.0,0.13944,"With regard to ovulatory cycles, there was no difference in the occurrence of pregnancy when comparing intercourse compliant versus intercourse noncompliant cycles.
","[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Pagidas', 'Affiliation': 'Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Providence, Rhode Island. Electronic address: kpagidas@wihri.org.'}, {'ForeName': 'Sandra A', 'Initials': 'SA', 'LastName': 'Carson', 'Affiliation': 'Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Providence, Rhode Island.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'McGovern', 'Affiliation': ""Department of Obstetrics, Gynecology and Women's Health, University of Medicine and Dentistry, New Jersey-New Jersey Medical School, Newark, New Jersey.""}, {'ForeName': 'Huiman X', 'Initials': 'HX', 'LastName': 'Barnhart', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Evan R', 'Initials': 'ER', 'LastName': 'Myers', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina; Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Legro', 'Affiliation': 'Department of Obstetrics and Gynecology, Pennsylvania State University, Hershey, Pennsylvania.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Diamond', 'Affiliation': 'Department of Obstetrics and Gynecology, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Carr', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Schlaff', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado, Denver, Colorado.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Coutifaris', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Steinkampf', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama, Birmingham, Alabama.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Cataldo', 'Affiliation': 'Stanford University, Palo Alto, California.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Nestler', 'Affiliation': 'Department of Medicine, Virginia Commonwealth University School of Medicine.'}, {'ForeName': 'Gabey', 'Initials': 'G', 'LastName': 'Gosman', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Giudice', 'Affiliation': 'Reproductive Sciences Branch, National Institute of Child Health and Human Development, Bethesda, Maryland, and Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Fertility and sterility,['10.1016/j.fertnstert.2009.05.047']
914,19022433,Two novel serum biomarkers for endometriosis screened by surface-enhanced laser desorption/ionization time-of-flight mass spectrometry and their change after laparoscopic removal of endometriosis.,"OBJECTIVE


To explore novel endometriosis serum biomarkers by surface-enhanced laser desorption/ionization time-of-flight mass spectrometry (SELDI-TOF-MS).
DESIGN


First, we aimed to discover the potential biomarkers of endometriosis by SELDI-TOF-MS. Second, blinded test was performed to characterize the effectiveness of the model by examining the sensitivity and specificity. Third, 29 postoperative patients with endometriosis were recruited to monitor the change of potential biomarkers after laparoscopic surgery.
SETTING


Collaborative investigation in an academic research environment.
PATIENT(S)


Fifty-nine patients with endometriosis, 31 patients without endometriosis, and 30 healthy volunteers.
INTERVENTION(S)


Blood serum of endometriosis and control group patients.
MAIN OUTCOME MEASURE(S)


Protein expression.
RESULT(S)


Two endometriosis-specific proteins were found in the preliminary screening study. Furthermore, the blinded test was performed and showed a sensitivity of 86.67% and a specificity of 96.77% of the markers for detecting endometriosis, which are significantly higher than those of CA-125 for distinguishing patients with endometriosis from patients without endometriosis. After surgery, the levels of these biomarker proteins decreased to levels comparable with those of patients without endometriosis.
CONCLUSION(S)


We discovered the potential biomarkers of endometriosis and set up a diagnostic model with a sensitivity of 86.67% and a specificity of 96.77%, which is significantly higher than that of CA-125 for detecting endometriosis, The levels of these proteins decreased to levels comparable with those of patients without endometriosis.",2009,"Furthermore, the blinded test was performed and showed a sensitivity of 86.67% and a specificity of 96.77% of the markers for detecting endometriosis, which are significantly higher than those of CA-125 for distinguishing patients with endometriosis from patients without endometriosis.","['29 postoperative patients with endometriosis', 'Fifty-nine patients with endometriosis, 31 patients without endometriosis, and 30 healthy volunteers']",['CA-125'],[],"[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0201549', 'cui_str': 'CA 125 measurement (procedure)'}]",[],59.0,0.0166332,"Furthermore, the blinded test was performed and showed a sensitivity of 86.67% and a specificity of 96.77% of the markers for detecting endometriosis, which are significantly higher than those of CA-125 for distinguishing patients with endometriosis from patients without endometriosis.","[{'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Jing', 'Affiliation': ""Department of Obstetrics and Gynecology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, People's Republic of China. Electronic address: jijiho66@163.com.""}, {'ForeName': 'Yuhuan', 'Initials': 'Y', 'LastName': 'Qiao', 'Affiliation': ""Department of Obstetrics and Gynecology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, People's Republic of China.""}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Suginami', 'Affiliation': 'Department of Obstetrics and Gynecology, National Hospital Organization Kyoto Medical Center, Fushimi, Kyoto, Japan; Hiroshi Suginami, Takanohara Central Hospital, Ukyo, Nara, Japan.'}, {'ForeName': 'Fumiaki', 'Initials': 'F', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Obstetrics and Gynecology, National Hospital Organization Kyoto Medical Center, Fushimi, Kyoto, Japan.'}, {'ForeName': 'Huirong', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': ""Department of Obstetrics and Gynecology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, People's Republic of China.""}, {'ForeName': 'Xiuli', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Center of Anal-Colorectal Surgery, the 150th Central Hospital of PLA, Luoyang, Henan Province, People's Republic of China.""}]",Fertility and sterility,['10.1016/j.fertnstert.2008.08.078']
915,19591981,"Polycystic ovary syndrome and cardiovascular risk in young patients treated with drospirenone-ethinylestradiol or contraceptive vaginal ring. A prospective, randomized, pilot study.","OBJECTIVE


To compare the effects of a pill containing drospirenone with those of a combined contraceptive vaginal ring on the lipid and carbohydrate metabolism and on the surrogate markers of arterial function.
SETTING


Bologna University School of Medicine.
PATIENT(S)


Thirty-seven women with polycystic ovary syndrome (PCOS) were randomly submitted to drospirenone+ethinylestradiol (group I; n=19) or combined contraceptive vaginal ring (group II; n=18) therapy. The duration of the study was 6 months.
INTERVENTION(S)


The effect of treatments was assessed after 6 months of therapy.
MAIN OUTCOME MEASURE(S)


Utero-ovarian ultrasound analysis and color Doppler evaluation of uterine and stromal ovarian arteries. In addition, analysis of brachial artery flow-mediated vasodilatation and 24-hour ambulatory blood pressure monitoring were performed. Fasting blood samples were drawn for testing biochemical and hormonal parameters and nitrites/nitrates.
RESULT(S)


Both treatments improved hirsutism, hyperandrogenemia, and ultrasound and color Doppler ovarian parameters. Both drospirenone+ethinylestradiol or contraceptive vaginal ring induced a slight but significant increase of diurnal and 24-hour blood pressure. Although both therapies worsened the lipid profile, the oral pill administration was associated with a more evident increase of circulating triglycerides. The 6-month treatment with the vaginal ring significantly improved the area under the curve for glucose, insulin, and C-peptide, whereas the drospirenone+ethinylestradiol pill induced an increase in the insulinogenic index and homeostatic model assessment estimate for insulin resistance values.
CONCLUSION(S)


Vaginal hormonal contraception appears to be preferable to oral ethinylestradiol + drospirenone administration in hyperinsulinemic patients with PCOS.",2010,"The 6-month treatment with the vaginal ring significantly improved the area under the curve for glucose, insulin, and C-peptide, whereas the drospirenone+ethinylestradiol pill induced an increase in the insulinogenic index and homeostatic model assessment estimate for insulin resistance values.
","['Bologna University School of Medicine', 'Thirty-seven women with polycystic ovary syndrome (PCOS', 'young patients treated with', 'hyperinsulinemic patients with PCOS', 'uterine and stromal ovarian arteries']","['drospirenone-ethinylestradiol or contraceptive vaginal ring', 'combined contraceptive vaginal ring', 'pill containing drospirenone', 'drospirenone+ethinylestradiol', 'ethinylestradiol + drospirenone']","['diurnal and 24-hour blood pressure', 'hirsutism, hyperandrogenemia, and ultrasound and color Doppler ovarian parameters', 'area under the curve for glucose, insulin, and C-peptide', 'brachial artery flow-mediated vasodilatation and 24-hour ambulatory blood pressure monitoring', 'circulating triglycerides', 'Fasting blood samples', 'Polycystic ovary syndrome and cardiovascular risk', 'insulinogenic index and homeostatic model assessment estimate for insulin resistance values']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0226411', 'cui_str': 'Structure of ovarian artery'}]","[{'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C1282173', 'cui_str': '24 hour blood pressure'}, {'cui': 'C0019572', 'cui_str': 'Hirsutism'}, {'cui': 'C1299574', 'cui_str': 'Hyperandrogenemia'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0006087', 'cui_str': 'Brachial Artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0042401', 'cui_str': 'Vasorelaxation'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0242876', 'cui_str': 'Blood Pressure Monitoring, Ambulatory'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",37.0,0.0364816,"The 6-month treatment with the vaginal ring significantly improved the area under the curve for glucose, insulin, and C-peptide, whereas the drospirenone+ethinylestradiol pill induced an increase in the insulinogenic index and homeostatic model assessment estimate for insulin resistance values.
","[{'ForeName': 'Cesare', 'Initials': 'C', 'LastName': 'Battaglia', 'Affiliation': 'Department of Gynecology and Pathophysiology of Human Reproduction, University of Bologna, Bologna, Italy. Electronic address: cesare.battaglia@unibo.it.'}, {'ForeName': 'Fulvia', 'Initials': 'F', 'LastName': 'Mancini', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Medicine, Institut Universitari Dexeus, Barcelona, Spain.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Fabbri', 'Affiliation': 'Department of Gynecology and Pathophysiology of Human Reproduction, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Persico', 'Affiliation': 'Department of Gynecology and Pathophysiology of Human Reproduction, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Busacchi', 'Affiliation': 'Department of Gynecology and Pathophysiology of Human Reproduction, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Facchinetti', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Modena-Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Venturoli', 'Affiliation': 'Department of Gynecology and Pathophysiology of Human Reproduction, University of Bologna, Bologna, Italy.'}]",Fertility and sterility,['10.1016/j.fertnstert.2009.05.044']
916,19608168,Single and multidose pharmacokinetic study of a vaginal micronized progesterone insert (Endometrin) compared with vaginal gel in healthy reproductive-aged female subjects.,"OBJECTIVE


To determine pharmacokinetic profiles of two times a day and three times a day dosage regimens of Endometrin, a micronized progesterone vaginal insert for luteal support in assisted reproductive technology, compared with a gel.
DESIGN


A single-center, randomized, open-label, single-day, and multiple-day (5 days) parallel design pharmacokinetic study.
SETTING


University clinical research unit.
PATIENT(S)


Three groups of six healthy subjects, ages 18 to 40 years.
INTERVENTION(S)


Endometrin vaginal inserts two times a day or three times a day, or gel daily.
MAIN OUTCOME MEASURE(S)


Pharmacokinetic profiles.
RESULT(S)


Progesterone serum concentrations increased rapidly following administration of Endometrin vaginal insert, producing higher peak concentrations (Cmax) and clearing faster than gel. On the single day of dosing, mean Cmax was 17.0+/-2.7 ng/mL in the two times a day group, 19.8+/-2.9 ng/mL in the three times a day group, and 6.82+/-1.69 ng/mL in the gel group. Endometrin treatments reached steady state within the first 2 days (24-36 hours), much more rapidly than the gel, which had not reached steady state by 5 days. At 5 days, the Endometrin treatments produced sustained progesterone concentrations exceeding 10 mg/mL across 24 hours.
CONCLUSIONS


Endometrin vaginal inserts reached higher Cmax, produced greater systemic exposure (area under the curve 0-24), achieved steady state more rapidly, and cleared more rapidly after termination of therapy than the comparator.",2010,"CONCLUSIONS


Endometrin vaginal inserts reached higher Cmax, produced greater systemic exposure (area under the curve 0-24), achieved steady state more rapidly, and cleared more rapidly after termination of therapy than the comparator.","['healthy reproductive-aged female subjects', 'University clinical research unit', 'Three groups of six healthy subjects, ages 18 to 40 years']","['vaginal micronized progesterone insert (Endometrin', 'Endometrin, a micronized progesterone vaginal', 'vaginal gel']","['sustained progesterone concentrations', 'peak concentrations (Cmax) and clearing faster', 'Progesterone serum concentrations', 'mean Cmax']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C1961968', 'cui_str': 'Endometrin'}, {'cui': 'C0042257', 'cui_str': 'Vaginal Jelly'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",6.0,0.0378758,"CONCLUSIONS


Endometrin vaginal inserts reached higher Cmax, produced greater systemic exposure (area under the curve 0-24), achieved steady state more rapidly, and cleared more rapidly after termination of therapy than the comparator.","[{'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Blake', 'Affiliation': 'Ferring Pharmaceuticals, Inc., Parsippany, New Jersey.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Norris', 'Affiliation': 'Division of Gynecology, Department of Obstetrics and Gynecology, Miller School of Medicine, University of Miami, Miami, Florida.'}, {'ForeName': 'Sally Faith', 'Initials': 'SF', 'LastName': 'Dorfman', 'Affiliation': 'Ferring Pharmaceuticals, Inc., Parsippany, New Jersey. Electronic address: Sally.Dorfman@Ferring.com.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Longstreth', 'Affiliation': 'Longstreth & Associates, Inc., Mundelein, Illinois.'}, {'ForeName': 'Vladimir I', 'Initials': 'VI', 'LastName': 'Yankov', 'Affiliation': 'Ferring Pharmaceuticals, Inc., Parsippany, New Jersey.'}]",Fertility and sterility,['10.1016/j.fertnstert.2009.06.014']
917,19567768,"Psychological distress in women with uterovaginal agenesis (Mayer-Rokitansky-Kuster-Hauser Syndrome, MRKH).","BACKGROUND


Uterovaginal agenesis (Mayer-Rokitansky-Küster-Hauser Syndrome; MRKH) is a congenital nonformation of the vagina and the uterus, but with normal ovaries.
OBJECTIVE


The authors investigated the psychological impact of this disorder, about which very little is known.
METHOD


A group of 66 women with MRKH were compared with 31 control-group women on a range of self-rating scales assessing psychological distress and self-esteem.
RESULTS


Women with MRKH had significantly more pathological scores on some of the scales and subscales, such as phobic anxiety and psychoticism (interpersonal alienation), with a similar trend for subscales measuring depression and anxiety.
CONCLUSION


MRKH has a lasting negative impact on affected women's level of psychological distress and self-esteem.",2009,"RESULTS


Women with MRKH had significantly more pathological scores on some of the scales and subscales, such as phobic anxiety and psychoticism (interpersonal alienation), with a similar trend for subscales measuring depression and anxiety.
","['women with uterovaginal agenesis (Mayer-Rokitansky-Kuster-Hauser Syndrome, MRKH', 'A group of 66 women with MRKH']","['31 control-group women on a range of self-rating scales assessing psychological distress and self-esteem', 'MRKH']","['pathological scores', 'phobic anxiety and psychoticism (interpersonal alienation', 'Psychological distress']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332907', 'cui_str': 'Congenital absence (morphologic abnormality)'}, {'cui': 'C1698581', 'cui_str': 'Mullerian Aplasia-Dysgenesis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0222045'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}]","[{'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0349231', 'cui_str': 'Phobias'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",66.0,0.119496,"RESULTS


Women with MRKH had significantly more pathological scores on some of the scales and subscales, such as phobic anxiety and psychoticism (interpersonal alienation), with a similar trend for subscales measuring depression and anxiety.
","[{'ForeName': 'Jacoline G', 'Initials': 'JG', 'LastName': 'Heller-Boersma', 'Affiliation': '""Scaling Your Mountains"" Therapeutic Practice, 11 Gregory St., The Attic Rm., Sandy Bay Holistic Veterinary Centre, Sandy Bay, Hobart, 7005 Tasmania, Australia. scalingyourmountains@bigpond.com'}, {'ForeName': 'Ulrike H', 'Initials': 'UH', 'LastName': 'Schmidt', 'Affiliation': ''}, {'ForeName': 'D Keith', 'Initials': 'DK', 'LastName': 'Edmonds', 'Affiliation': ''}]",Psychosomatics,['10.1176/appi.psy.50.3.277']
918,19541299,"GnRH analogue treatment before hysteroscopic resection of submucous myomas: a prospective, randomized, multicenter study.","OBJECTIVE


To evaluate the efficacy of GnRH analogue treatment before hysteroscopic resection of submucous myomas in patients with abnormal uterine bleeding.
DESIGN


Multicenter, prospective, randomized, clinical study.
SETTING


Tertiary-care university hospitals.
PATIENT(S)


Thirty-nine consecutive patients with submucous myomas graded as G0 or G1 according to the European Society for Gynecological Endoscopy classification (myoma size 10-35 mm).
INTERVENTION(S)


Patients were randomized to either direct surgery or 2 months of GnRH analogues before undergoing hysteroscopic resection of the submucous myoma.
MAIN OUTCOME MEASURE(S)


Operating times, fluid absorption, difficulty of the operation, surgeon satisfaction with the procedure, intra- and postoperative complications, postoperative pain, and patient satisfaction were recorded.
RESULT(S)


Patients treated with GnRH analogue had significantly shorter operative times (15.9+/-3.1 minutes vs. 21.3+/-4.0 minutes) and significantly reduced fluid absorption (378+/-137 mL vs. 566+/-199 mL) compared with no preoperative medical treatment. Operative difficulty and overall surgeon satisfaction were significantly better in the GnRH analogue group. Patient satisfaction was similar in the two groups.
CONCLUSION(S)


GnRH analogue treatment before hysteroscopic resection of G0-G1 10-35 mm submucous myomas was effective in reducing operative times, fluid absorption, and difficulty of the procedure.",2010,"GnRH analogue treatment before hysteroscopic resection of G0-G1 10-35 mm submucous myomas was effective in reducing operative times, fluid absorption, and difficulty of the procedure.","['patients with abnormal uterine bleeding', 'Thirty-nine consecutive patients with submucous myomas graded as G0 or G1 according to the European Society for Gynecological Endoscopy classification (myoma size 10-35 mm', 'before hysteroscopic resection of submucous myomas', 'Tertiary-care university hospitals']","['GnRH analogue treatment before hysteroscopic resection', 'direct surgery or 2 months of GnRH analogues before undergoing hysteroscopic resection of the submucous myoma', 'GnRH analogue treatment']","['Operating times, fluid absorption, difficulty of the operation, surgeon satisfaction with the procedure, intra- and postoperative complications, postoperative pain, and patient satisfaction', 'Patient satisfaction', 'shorter operative times', 'operative times, fluid absorption, and difficulty of the procedure', 'fluid absorption', 'Operative difficulty and overall surgeon satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3650625', 'cui_str': 'Abnormal uterine bleeding (disorder)'}, {'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0473278', 'cui_str': 'Gynecological endoscopic examination (procedure)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0027086', 'cui_str': 'Myoma'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0027086', 'cui_str': 'Myoma'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",39.0,0.111229,"GnRH analogue treatment before hysteroscopic resection of G0-G1 10-35 mm submucous myomas was effective in reducing operative times, fluid absorption, and difficulty of the procedure.","[{'ForeName': 'Ludovico', 'Initials': 'L', 'LastName': 'Muzii', 'Affiliation': 'Department of Obstetrics and Gynecology, Campus Bio-Medico University, Rome, Italy. Electronic address: l.muzii@unicampus.it.'}, {'ForeName': 'Terenzio', 'Initials': 'T', 'LastName': 'Boni', 'Affiliation': 'Department of Obstetrics and Gynecology, ""Sapienza"" University, Rome, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Bellati', 'Affiliation': 'Department of Obstetrics and Gynecology, ""Sapienza"" University, Rome, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Marana', 'Affiliation': 'Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart and International Scientific Institute ""Paolo VI,"" Rome, Italy.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Ruggiero', 'Affiliation': 'Department of Obstetrics and Gynecology, Campus Bio-Medico University, Rome, Italy.'}, {'ForeName': 'Marzio A', 'Initials': 'MA', 'LastName': 'Zullo', 'Affiliation': 'Department of Obstetrics and Gynecology, Campus Bio-Medico University, Rome, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Angioli', 'Affiliation': 'Department of Obstetrics and Gynecology, Campus Bio-Medico University, Rome, Italy.'}, {'ForeName': 'Pierluigi Benedetti', 'Initials': 'PB', 'LastName': 'Panici', 'Affiliation': 'Department of Obstetrics and Gynecology, ""Sapienza"" University, Rome, Italy.'}]",Fertility and sterility,['10.1016/j.fertnstert.2009.05.070']
919,18829015,Gonadotropin administration after gonadotropin-releasing-hormone agonist: a therapeutic option in severe testiculopathies.,"OBJECTIVE


To evaluate the effect of recombinant human follicle-stimulating hormone (FSH) plus human chorionic gonadotropin (hCG) on seminal parameters and pregnancy rate in severe testiculopathies after high FSH plasma concentrations have been suppressed.
DESIGN


Prospective, controlled, randomized clinical study.
SETTING


Infertility center at a university hospital.
PATIENT(S)


Eighty-seven men affected by severe testiculopathy.
INTERVENTION(S)


We treated 57 men with a gonadotropin-releasing hormone agonist (GnRH-a) and then with recombinant human FSH and hCG, and 30 patients did not receive any treatment. Seminal parameters and sperm aneuploidies were evaluated during and after the treatment period. Couples did not achieve a spontaneous pregnancy received assisted reproduction treatment.
MAIN OUTCOME MEASURE(S)


Seminal parameters, sperm aneuploidies, testicular cytologic analysis, FSH, luteinizing hormone, testosterone, inhibin B concentrations, and pregnancy rate.
RESULT(S)


After the therapy period, the treated group showed statistically significant improvement in sperm parameters and sperm aneuploidies. No changes were observed in the untreated group. A trend toward an increase in pregnancy rate also was observed among treated couples (cumulative pregnancy rates 31.6% treated vs. 20.0% untreated), although the increase was not statistically significant. The improvement of seminal parameters in the treated group allowed some patients to undergo in vitro fertilization-embryo transfer instead of intracytoplasmic sperm injection.
CONCLUSION(S)


Results from this controlled, randomized clinical trial show that FSH therapy improves sperm parameters in severe male factor infertility when endogenous high FSH plasma levels are suppressed. In cases of severely impaired testicles, a rational treatment of male infertility is mandatory to improve the outcome of assisted reproduction techniques.",2009,"In cases of severely impaired testicles, a rational treatment of male infertility is mandatory to improve the outcome of assisted reproduction techniques.","['57 men with a', '\n\n\nEighty-seven men affected by severe testiculopathy.\nINTERVENTION(S', 'Infertility center at a university hospital']","['Gonadotropin administration after gonadotropin-releasing-hormone agonist', 'gonadotropin-releasing hormone agonist (GnRH-a) and then with recombinant human FSH and hCG', 'FSH therapy', 'recombinant human follicle-stimulating hormone (FSH) plus human chorionic gonadotropin (hCG']","['Seminal parameters and sperm aneuploidies', 'seminal parameters', 'Seminal parameters, sperm aneuploidies, testicular cytologic analysis, FSH, luteinizing hormone, testosterone, inhibin B concentrations, and pregnancy rate', 'sperm parameters', 'pregnancy rate', 'sperm parameters and sperm aneuploidies']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0016774', 'cui_str': 'Follicle Stimulating Hormone, Human'}, {'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement (procedure)'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0037868', 'cui_str': 'Sperm'}, {'cui': 'C0002938', 'cui_str': 'Aneuploid'}, {'cui': 'C0205471', 'cui_str': 'Cytologic (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0023607', 'cui_str': 'Luteinizing Hormone'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0971174', 'cui_str': 'inhibin B'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}]",87.0,0.102563,"In cases of severely impaired testicles, a rational treatment of male infertility is mandatory to improve the outcome of assisted reproduction techniques.","[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Foresta', 'Affiliation': 'Section of Clinical Pathology and Centre for Male Gamete Cryopreservation, Department of Histology, Microbiology, and Medical Biotechnologies, University of Padova, Padova, Italy. Electronic address: carlo.foresta@unipd.it.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Selice', 'Affiliation': 'Section of Clinical Pathology and Centre for Male Gamete Cryopreservation, Department of Histology, Microbiology, and Medical Biotechnologies, University of Padova, Padova, Italy.'}, {'ForeName': 'Afra', 'Initials': 'A', 'LastName': 'Moretti', 'Affiliation': 'Section of Clinical Pathology and Centre for Male Gamete Cryopreservation, Department of Histology, Microbiology, and Medical Biotechnologies, University of Padova, Padova, Italy.'}, {'ForeName': 'Mauro Antonio', 'Initials': 'MA', 'LastName': 'Pati', 'Affiliation': 'Section of Clinical Pathology and Centre for Male Gamete Cryopreservation, Department of Histology, Microbiology, and Medical Biotechnologies, University of Padova, Padova, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Carraro', 'Affiliation': 'Section of Clinical Pathology and Centre for Male Gamete Cryopreservation, Department of Histology, Microbiology, and Medical Biotechnologies, University of Padova, Padova, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Engl', 'Affiliation': 'Obstetrics and Gynaecology Unit, Brunico, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Garolla', 'Affiliation': 'Section of Clinical Pathology and Centre for Male Gamete Cryopreservation, Department of Histology, Microbiology, and Medical Biotechnologies, University of Padova, Padova, Italy.'}]",Fertility and sterility,['10.1016/j.fertnstert.2008.07.1766']
920,19356750,Patient satisfaction and clinical outcome after injecting gonadotropins with use of a needle-free carbon dioxide injection system for controlled ovarian hyperstimulation for in vitro fertilization.,"In this prospective, randomized clinical trial, we tested the hypothesis that a needle-free CO(2) injection system (Biojector 2000) would be better tolerated by patients when compared with traditional sharp needles used for gonadotropin injections during stimulation for IVF. As measured by our questionnaire, the needle-free CO(2) injection system was not better tolerated by patients, even though it was equally effective clinically.",2009,"As measured by our questionnaire, the needle-free CO(2) injection system was not better tolerated by patients, even though it was equally effective clinically.",['controlled ovarian hyperstimulation for in vitro fertilization'],"['gonadotropin injections', 'needle-free carbon dioxide injection system', 'needle-free CO(2) injection system (Biojector 2000']",[],"[{'cui': 'C3160882', 'cui_str': 'Controlled ovarian hyperstimulation'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}]","[{'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0470277', 'cui_str': '2000'}]",[],,0.0214955,"As measured by our questionnaire, the needle-free CO(2) injection system was not better tolerated by patients, even though it was equally effective clinically.","[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Solnica', 'Affiliation': 'New Jersey Medical School/University of Medicine and Dentistry of New Jersey, Newark, New Jersey.'}, {'ForeName': 'Cheongeun', 'Initials': 'C', 'LastName': 'Oh', 'Affiliation': 'New York University School of Medicine, Department of Environmental Medicine, New York, New York.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Cho', 'Affiliation': 'New Jersey Medical School/University of Medicine and Dentistry of New Jersey, Newark, New Jersey; University Reproductive Associates, Hasbrouck Heights, New Jersey.'}, {'ForeName': 'Jacquelyn S', 'Initials': 'JS', 'LastName': 'Loughlin', 'Affiliation': 'New Jersey Medical School/University of Medicine and Dentistry of New Jersey, Newark, New Jersey; University Reproductive Associates, Hasbrouck Heights, New Jersey.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'McCulloh', 'Affiliation': 'New Jersey Medical School/University of Medicine and Dentistry of New Jersey, Newark, New Jersey; University Reproductive Associates, Hasbrouck Heights, New Jersey.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'McGovern', 'Affiliation': 'New Jersey Medical School/University of Medicine and Dentistry of New Jersey, Newark, New Jersey; University Reproductive Associates, Hasbrouck Heights, New Jersey. Electronic address: mcgovepg@umdnj.edu.'}]",Fertility and sterility,['10.1016/j.fertnstert.2009.03.013']
921,18973893,Low-dose aspirin in non-tubal IVF patients with previous failed conception: a prospective randomized double-blind placebo-controlled trial.,"OBJECTIVE


To analyze whether the administration of low-dose aspirin during IVF treatment improves the uterine blood flow and improves ongoing pregnancy rates for non-tubal factor IVF patients with previous failed conception.
DESIGN


Prospective double-blind placebo-controlled trial.
SETTING


University fertility clinic.
PATIENT(S)


Non-tubal IVF patients with previous failed conception.
INTERVENTION(S)


Daily 100 mg aspirin or placebo throughout an IVF treatment with a long GnRH-agonist stimulation protocol.
MAIN OUTCOME MEASURE(S)


Ongoing pregnancy rate, pulsatility index of the uterine artery.
RESULT(S)


Of 169 patients, 84 were assigned to aspirin treatment and 85 to placebo treatment. In the aspirin group, 28 patients (35.4%) had an ongoing pregnancy, and in the placebo group, 26 patients (31.0%) had an ongoing pregnancy. Multilevel analyses showed that the pulsatility index of the uterine artery was not affected by aspirin or placebo treatment.
CONCLUSION(S)


Low-dose aspirin administration during IVF treatment does not improve pregnancy rates of non-tubal factor IVF patients with previous failed conception, and it does not affect the arterial uterine blood flow.",2009,"In the aspirin group, 28 patients (35.4%) had an ongoing pregnancy, and in the placebo group, 26 patients (31.0%) had an ongoing pregnancy.","['non-tubal factor IVF patients with previous failed conception', '169 patients, 84 were assigned to', 'University fertility clinic', 'non-tubal IVF patients with previous failed conception', '\n\n\nNon-tubal IVF patients with previous failed conception']","['Low-dose aspirin', 'placebo', 'low-dose aspirin', 'aspirin or placebo', 'aspirin']","['Ongoing pregnancy rate, pulsatility index of the uterine artery', 'arterial uterine blood flow', 'uterine blood flow and improves ongoing pregnancy rates', 'pregnancy rates', 'pulsatility index of the uterine artery']","[{'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0226378', 'cui_str': 'Uterine Artery'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",169.0,0.684864,"In the aspirin group, 28 patients (35.4%) had an ongoing pregnancy, and in the placebo group, 26 patients (31.0%) had an ongoing pregnancy.","[{'ForeName': 'Marieke J', 'Initials': 'MJ', 'LastName': 'Lambers', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Medicine Free University Medical Center, Amsterdam, The Netherlands. Electronic address: mj.lambers@vumc.nl.'}, {'ForeName': 'Diederik A', 'Initials': 'DA', 'LastName': 'Hoozemans', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Medicine Free University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Roel', 'Initials': 'R', 'LastName': 'Schats', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Medicine Free University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Homburg', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Medicine Free University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Cornelis B', 'Initials': 'CB', 'LastName': 'Lambalk', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Medicine Free University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter G A', 'Initials': 'PGA', 'LastName': 'Hompes', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Medicine Free University Medical Center, Amsterdam, The Netherlands.'}]",Fertility and sterility,['10.1016/j.fertnstert.2008.07.1759']
922,18930212,The impact of electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cysts: a prospective clinical study of 191 patients.,"OBJECTIVE


To investigate the impact of electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cysts and the possible mechanisms.
DESIGN


A prospective study.
SETTING


Obstetrics and Gynecology Department of a university hospital.
PATIENT(S)


191 patients with benign ovarian cysts undergoing ovarian cystectomy.
INTERVENTION(S)


Laparoscopic ovarian cystectomy using bipolar or ultrasonic scalpel electrocoagulation and laparotomic ovarian cystectomy using sutures after the excision of ovarian cysts.
MAIN OUTCOME MEASURE(S)


Follicle-stimulating hormone (FSH) assay and transvaginal ultrasound evaluating basal antral follicle number, mean ovarian diameter, and ovarian stromal blood flow velocity at day 3 of menstrual cycles 1, 3, 6, and 12 after surgery.
RESULT(S)


When comparing the bipolar group and ultrasonic scalpel group with the suture group, a statistically significant increase of the mean FSH value was found in bilateral-cyst patients at 1-, 3-, 6-, and 12-month follow-up evaluations and in unilateral-cyst patients at the 1-month follow-up evaluation. Statistically significant decreases of basal antral follicle number and mean ovarian diameter were found during the 3-, 6-, 12-month follow-up evaluations as well as statistically significant decreases of peak systolic velocity at all of the follow-up evaluations.
CONCLUSION(S)


Electrocoagulation after laparoscopic excision of ovarian cysts is associated with a statistically significant reduction in ovarian reserve, which is partly a consequence of the damage to the ovarian vascular system.",2009,"Statistically significant decreases of basal antral follicle number and mean ovarian diameter were found during the 3-, 6-, 12-month follow-up evaluations as well as statistically significant decreases of peak systolic velocity at all of the follow-up evaluations.
","['Obstetrics and Gynecology Department of a university hospital', '191 patients with benign ovarian cysts undergoing ovarian cystectomy', 'after laparoscopic excision of ovarian cysts', '191 patients']","['Laparoscopic ovarian cystectomy using bipolar or ultrasonic scalpel electrocoagulation and laparotomic ovarian cystectomy using sutures', 'ultrasonic scalpel', 'Electrocoagulation', 'electrocoagulation']","['peak systolic velocity', 'ovarian reserve', 'Follicle-stimulating hormone (FSH) assay and transvaginal ultrasound evaluating basal antral follicle number, mean ovarian diameter, and ovarian stromal blood flow velocity', 'basal antral follicle number and mean ovarian diameter', 'mean FSH value']","[{'cui': 'C0587480', 'cui_str': 'Obstetrics and gynecology department (environment)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0740364', 'cui_str': 'Benign cyst of ovary'}, {'cui': 'C0195488', 'cui_str': 'Removal of ovarian cyst (procedure)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0029927', 'cui_str': 'Ovarian Cysts'}]","[{'cui': 'C0195488', 'cui_str': 'Removal of ovarian cyst (procedure)'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C1456803', 'cui_str': 'Ultrasonics'}, {'cui': 'C0392220', 'cui_str': 'Surgical knife, device (physical object)'}, {'cui': 'C0013804', 'cui_str': 'Surgical Diathermy'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}]","[{'cui': 'C0442710', 'cui_str': 'Peak systolic, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",191.0,0.0333383,"Statistically significant decreases of basal antral follicle number and mean ovarian diameter were found during the 3-, 6-, 12-month follow-up evaluations as well as statistically significant decreases of peak systolic velocity at all of the follow-up evaluations.
","[{'ForeName': 'Chang-Zhong', 'Initials': 'CZ', 'LastName': 'Li', 'Affiliation': ""Department of Obstetrics and Gynecology, Shandong Provincial Hospital, Shandong University, Jinan, People's Republic of China. Electronic address: lichangzhong@hotmail.com.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': ""Department of Oncology, Shandong Tumor Hospital, Jinan, People's Republic of China.""}, {'ForeName': 'Ze-Qing', 'Initials': 'ZQ', 'LastName': 'Wen', 'Affiliation': ""Department of Obstetrics and Gynecology, Shandong Provincial Hospital, Shandong University, Jinan, People's Republic of China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': ""School of Public Health, Shandong University, Jinan, People's Republic of China.""}]",Fertility and sterility,['10.1016/j.fertnstert.2008.08.071']
923,18930224,Laparoscopic management of ureteral lesions in gynecology.,"OBJECTIVE


To investigate the outcome of laparoscopic repair of ureteral injury in laparoscopic gynecologic surgery.
DESIGN


Prospective trial.
SETTING


University hospital.
PATIENT(S)


Forty patients with a ureteral lesion in laparoscopic surgery between 1991 and 2007.
INTERVENTION(S)


Laparoscopic ureteral repair, laparoscopic-assisted or blind stent insertion.
MAIN OUTCOME MEASURE(S)


Treatment outcome of ureteral lesion analyzed by type of injury, time of diagnosis, and management.
RESULT(S)


In 4,350 consecutive laparoscopic gynecologic interventions, 42 lesions occurred, 5 during hysterectomy, 1 during adnexectomy, and 36 during deep endometriosis surgery. In the latter group (n = 1,427), the incidence was 1.5% and 21% in women without and with hydronephrosis, respectively. In eight women in whom a stent was inserted after surgery without laparoscopic guidance, five were uneventful and three needed a second intervention. In all 34 women in whom a laparoscopic repair over a stent was performed, the outcome was uneventful, whether diagnosed and treated during surgery (n = 25) or after surgery (n = 9).
CONCLUSION(S)


Laparoscopic repair over a stent was uneventful for all lacerations, transections, and fistulas, whether performed during or after surgery, and was superior to blind stent insertion. In women with hydronephrosis and deep endometriosis, a preoperative stent insertion seems to be mandatory.",2009,"Laparoscopic repair over a stent was uneventful for all lacerations, transections, and fistulas, whether performed during or after surgery, and was superior to blind stent insertion.","['University hospital', '\n\n\nForty patients with a ureteral lesion in laparoscopic surgery between 1991 and 2007', '4,350 consecutive laparoscopic gynecologic interventions, 42 lesions occurred, 5 during hysterectomy, 1 during adnexectomy, and 36 during deep endometriosis surgery', 'women with hydronephrosis and deep endometriosis', '34 women in whom a', 'ureteral lesions in gynecology']","['Laparoscopic repair', 'Laparoscopic management', 'laparoscopic repair', 'laparoscopic gynecologic surgery', 'Laparoscopic ureteral repair, laparoscopic-assisted or blind stent insertion']","['ureteral lesion analyzed by type of injury, time of diagnosis, and management']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0036132', 'cui_str': 'Salpingo-oophorectomy'}, {'cui': 'C4510788', 'cui_str': 'Deep endometriosis'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0020295', 'cui_str': 'Hydronephrosis'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}]","[{'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0038902', 'cui_str': 'Gynecological Surgical Procedure'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0522776', 'cui_str': 'Placement of stent (procedure)'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0449499', 'cui_str': 'Type of injury (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]",40.0,0.295032,"Laparoscopic repair over a stent was uneventful for all lacerations, transections, and fistulas, whether performed during or after surgery, and was superior to blind stent insertion.","[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'De Cicco', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium; Department of Obstetrics and Gynecology, University Hospital A. Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy. Electronic address: carlodecicco@gmail.com.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Schonman', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Craessaerts', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Van Cleynenbreugel', 'Affiliation': 'Department of Urology, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Ussia', 'Affiliation': 'Department of Obstetrics and Gynecology, Villa Giose, Crotone, Italy.'}, {'ForeName': 'Philippe Robert', 'Initials': 'PR', 'LastName': 'Koninckx', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium; Department of Obstetrics and Gynecology, University Hospital A. Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy.'}]",Fertility and sterility,['10.1016/j.fertnstert.2008.08.021']
924,18793779,The DNA integrity of cryopreserved spermatozoa separated for use in assisted reproductive technology is unaffected by the type of cryoprotectant used but is related to the DNA integrity of the fresh separated preparation.,"OBJECTIVE


To investigate and compare seven different commercially available cryoprotectant media in terms of the DNA integrity of spermatozoa recovered after cryopreservation and separation using density gradient centrifugation (DGC).
DESIGN


A prospective clinical study.
SETTING


Tertiary care fertility clinic.
PATIENT(S)


Three hundred twenty men presenting for infertility investigations.
INTERVENTION(S)


Each sample was randomly assigned to one of seven commercially available cryoprotectants or to no cryoprotectant.
MAIN OUTCOME MEASURE(S)


Percentage sperm DNA fragmentation after cryopreservation and preparation using DGC.
RESULT(S)


The mean percentage fragmentation was significantly higher post-thaw and post-DGC; however, some patients (26.3%) demonstrated a lower percentage fragmentation post-thaw. No single cryoprotectant was identified as the best at preserving DNA integrity. The difference in fragmentation after thawing and DGC was found to be highly dependent on the prefreeze fragmentation. Motility was also significantly correlated with the difference in fragmentation post-thaw (r = -0.161).
CONCLUSION(S)


Neither the presence nor type of cryoprotectant affects the DNA integrity of spermatozoa after cryopreservation and DGC. Individuals with lower prefreeze fragmentation in DGC-prepared spermatozoa have larger increases in fragmentation and are less likely to exhibit lower levels of fragmentation post-thaw. The reverse effect observed in those with higher prefreeze fragmentation gives rise to a possible novel method of reducing fragmentation in sperm used for assisted reproductive technology treatment cycles without the need for testicular sperm retrievals.",2009,Neither the presence nor type of cryoprotectant affects the DNA integrity of spermatozoa after cryopreservation and DGC.,"['\n\n\nThree hundred twenty men presenting for infertility investigations', 'Tertiary care fertility clinic']",['seven commercially available cryoprotectants or to no cryoprotectant'],"['Percentage sperm DNA fragmentation', 'Motility', 'mean percentage fragmentation']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0037868', 'cui_str': 'Sperm'}, {'cui': 'C0376669', 'cui_str': 'DNA Fragmentation'}, {'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation (morphologic abnormality)'}]",320.0,0.0255268,Neither the presence nor type of cryoprotectant affects the DNA integrity of spermatozoa after cryopreservation and DGC.,"[{'ForeName': 'Laura Kelly', 'Initials': 'LK', 'LastName': 'Thomson', 'Affiliation': 'Fertility First, Hurstville, Australia. Electronic address: lthomson@fertilityfirst.com.au.'}, {'ForeName': 'Steven Denis', 'Initials': 'SD', 'LastName': 'Fleming', 'Affiliation': 'Department of Obstetrics and Gynecology, Westmead Hospital, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Schulke', 'Affiliation': 'Fertility First, Hurstville, Australia.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Barone', 'Affiliation': 'Fertility First, Hurstville, Australia.'}, {'ForeName': 'Julie-Anne', 'Initials': 'JA', 'LastName': 'Zieschang', 'Affiliation': 'Fertility First, Hurstville, Australia.'}, {'ForeName': 'Anne Melton', 'Initials': 'AM', 'LastName': 'Clark', 'Affiliation': 'Fertility First, Hurstville, Australia.'}]",Fertility and sterility,['10.1016/j.fertnstert.2008.07.1747']
925,18177867,Comparison of efficacy of aromatase inhibitor and clomiphene citrate in induction of ovulation in polycystic ovarian syndrome.,"OBJECTIVE


To compare the effectiveness of letrozole and clomiphene citrate (CC) in induction of ovulation in polycystic ovary syndrome (PCOS).
DESIGN


Prospective, randomized, not blinded, controlled trial.
SETTING


A tertiary level infertility care center.
PATIENT(S)


Sixty-four anovulatory patients with PCOS, who failed to ovulate when taking 100 mg/day CC in previous cycles.
INTERVENTION(S)


Patients were randomly divided into two groups by lottery and treated with either 7.5 mg/day letrozole (an aromatase inhibitor) or 150 mg/day CC for 5 days starting from day 3 of the menstrual cycle.
MAIN OUTCOME MEASURE(S)


Occurrence of ovulation, endometrial thickness, and pregnancy rate (PR).
RESULT(S)


Twenty (62.5%) patients from the letrozole group and 12 (37.50%) patients from the CC group ovulated during the observation period. Mean serum E2 level was 817.75 pg/mL and 448.03 pg/mL in the CC and letrozole groups, respectively, on the day of hCG administration. The mean endometrial thickness on the day of hCG administration was 9.03 mm and 10.37 mm in the CC and letrozole groups, respectively. The mean D21 serum P was 13.09 ng/mL and 19.09 ng/mL in the CC and letrozole groups, respectively. Thirteen patients from the letrozole group (40.63%) and six patients from the CC group (18.75%) became pregnant.
CONCLUSION(S)


Letrozole has better ovulation and PR in comparison to CC in patients with PCOS.",2009,"Mean serum E2 level was 817.75 pg/mL and 448.03 pg/mL in the CC and letrozole groups, respectively, on the day of hCG administration.","['\n\n\nTwenty (62.5', 'polycystic ovarian syndrome', '\n\n\nSixty-four anovulatory patients with PCOS, who failed to ovulate when taking 100 mg/day CC in previous cycles', 'A tertiary level infertility care center', 'patients with PCOS', 'polycystic ovary syndrome (PCOS']","['aromatase inhibitor and clomiphene citrate', 'letrozole (an aromatase inhibitor', 'letrozole', 'Letrozole', 'letrozole and clomiphene citrate (CC', 'hCG']","['Mean serum E2 level', 'mean endometrial thickness', 'mean D21 serum P', 'Occurrence of ovulation, endometrial thickness, and pregnancy rate (PR']","[{'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0429468', 'cui_str': 'Anovulatory (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1171199', 'cui_str': 'Family planning: infertility'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}]",,0.0386652,"Mean serum E2 level was 817.75 pg/mL and 448.03 pg/mL in the CC and letrozole groups, respectively, on the day of hCG administration.","[{'ForeName': 'Mosammat Rashida', 'Initials': 'MR', 'LastName': 'Begum', 'Affiliation': 'Dhaka Medical College, Dhaka, Bangladesh. Electronic address: rashida_icrc@yahoo.com.'}, {'ForeName': 'Jannatul', 'Initials': 'J', 'LastName': 'Ferdous', 'Affiliation': 'Bangabandhu Sheik Mujib University, Dhaka, Bangladesh.'}, {'ForeName': 'Anowara', 'Initials': 'A', 'LastName': 'Begum', 'Affiliation': 'Dhaka Medical College, Dhaka, Bangladesh.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Quadir', 'Affiliation': 'Sir Salimullah Medical College, Dhaka, Bangladesh.'}]",Fertility and sterility,['10.1016/j.fertnstert.2007.08.044']
926,18692823,Clomiphene citrate or aromatase inhibitors for superovulation in women with unexplained infertility undergoing intrauterine insemination: a prospective randomized trial.,"OBJECTIVE


To compare clomiphene citrate (CC) and letrozole used for superovulation before intrauterine insemination (IUI) in unexplained infertility.
DESIGN


Prospective randomized trial.
SETTING


A university teaching hospital and a private practice setting.
PATIENT(S)


Four hundred and twelve infertile women with unexplained infertility.
INTERVENTION(S)


Patients were randomized to treatment with 100 mg of CC daily (207 patients, 404 cycles) or 5 mg of letrozole daily (205 patients, 400 cycles) for 5 days starting on day 3 of menses. The IUI was done 36 +/- 4 hours after human chorionic gonadotropin (hCG) injection.
MAIN OUTCOME MEASURE(S)


Number of follicles, serum estradiol level, serum progesterone level, endometrial thickness, and pregnancy and miscarriage rates.
RESULT(S)


The total number of follicles during stimulation was statistically significantly greater in the CC group (3.1 +/- 0.36 vs. 1.6 +/- 0.41). There was no statistically significant difference in pretreatment endometrial thickness between the two groups or endometrial thickness at the time of hCG administration. Serum E(2) and progesterone concentrations were statistically significantly higher in the CC group. The days to hCG injection were similar in both groups. Pregnancy occurred in 73 out of 205 patients (400 cycles) in the letrozole group (35.6% and 18.2%, respectively) and 78 out of 207 patients (404 cycles) (37.6% and 19.3%, respectively) in the CC group; the differences were not statistically significant. Two twin pregnancies occurred in the CC group.
CONCLUSION(S)


This study found no superiority between letrozole and CC for inducing ovulation in women with unexplained infertility before IUI.",2009,There was no statistically significant difference in pretreatment endometrial thickness between the two groups or endometrial thickness at the time of hCG administration.,"['women with unexplained infertility before IUI', 'women with unexplained infertility undergoing intrauterine insemination', 'Four hundred and twelve infertile women with unexplained infertility', 'A university teaching hospital and a private practice setting']","['clomiphene citrate (CC) and letrozole', 'human chorionic gonadotropin (hCG) injection', 'letrozole and CC', 'letrozole', 'Clomiphene citrate or aromatase inhibitors']","['Pregnancy', 'pretreatment endometrial thickness', 'total number of follicles during stimulation', 'Number of follicles, serum estradiol level, serum progesterone level, endometrial thickness, and pregnancy and miscarriage rates', 'Serum E(2) and progesterone concentrations']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility (finding)'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination (procedure)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0036849', 'cui_str': 'Set'}]","[{'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement (procedure)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}]","[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0428410', 'cui_str': 'Serum progesterone measurement'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",412.0,0.07962,There was no statistically significant difference in pretreatment endometrial thickness between the two groups or endometrial thickness at the time of hCG administration.,"[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Badawy', 'Affiliation': 'Department of Obstetrics and Gynecology, Mansoura University, Mansoura, Egypt. Electronic address: ambadawy@yahoo.com.'}, {'ForeName': 'Abubaker', 'Initials': 'A', 'LastName': 'Elnashar', 'Affiliation': 'Department of Obstetrics and Gynecology, Benha University, Benha, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Totongy', 'Affiliation': 'Department of Obstetrics and Gynecology, Mansoura University, Mansoura, Egypt.'}]",Fertility and sterility,['10.1016/j.fertnstert.2008.06.013']
927,32432339,Time course of 75%-100% efficacy response of adjunctive brivaracetam.,"BACKGROUND


Time to sustained seizure frequency reduction can provide clinically meaningful epilepsy outcomes.
AIMS OF THE STUDY


To examine the time course of brivaracetam (BRV) efficacy in adults with focal seizures and focal to bilateral tonic-clonic seizures (FBTCS).
METHODS


Post hoc analysis of data pooled from three randomized controlled trials of oral adjunctive BRV in adults with epilepsy. Patients with focal epilepsy and a subpopulation with FBTCS receiving BRV 50, 100, or 200 mg/d (initiated without up-titration) or placebo for 12 weeks were analyzed for time to sustained ≥75%, ≥90%, and 100% seizure reduction without interruption from first day until trial ends.
RESULTS


Evaluation included 1160 patients with focal seizures, including 352 patients with FBTCS. Sustained ≥75%, ≥90%, and 100% response in focal seizures was higher from day 1 for BRV 100 and 200 mg/d vs placebo (P < .01). Sustained ≥75% and 100% FBTCS reduction from day 1 was higher for BRV 100 and 200-mg/d groups vs placebo (P < .01).
CONCLUSIONS


The majority of patients achieving 75%-100% sustained seizure frequency reduction (all focal seizure types and the subpopulation with FBTCS) with oral BRV (100 or 200 mg/d) achieved this response on the first-treatment day.",2020,"Sustained ≥75% and 100% FBTCS reduction from day 1 was higher for BRV 100 and 200-mg/d groups vs placebo (P <.01).
","['1160 patients with focal seizures, including 352 patients with FBTCS', 'Patients with focal epilepsy and a subpopulation with FBTCS receiving BRV 50, 100, or 200 mg/d (initiated without up-titration) or', 'adults with focal seizures and focal to bilateral tonic-clonic seizures (FBTCS', 'adults with epilepsy']","['oral adjunctive BRV', 'adjunctive brivaracetam', 'oral BRV', 'placebo']","['focal seizures', 'time course of brivaracetam (BRV) efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C0014547', 'cui_str': 'Localization-related epilepsy'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",1160.0,0.262434,"Sustained ≥75% and 100% FBTCS reduction from day 1 was higher for BRV 100 and 200-mg/d groups vs placebo (P <.01).
","[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, Bethesda, MD, USA.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Laloyaux', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Elmoufti', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gasalla', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA.'}, {'ForeName': 'Melinda S', 'Initials': 'MS', 'LastName': 'Martin', 'Affiliation': 'UCB Pharma, Smyrna, GA, USA.'}]",Acta neurologica Scandinavica,['10.1111/ane.13287']
928,31981566,Change in Clinical Practice Associated With a Large Randomized Controlled Trial Comparing RBC Transfusion Strategies.,,2020,,[],[],[],[],[],[],,0.109654,,"[{'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Trentino', 'Affiliation': 'School of Population and Global Health, University of Western Australia, Perth, Australia; Data and Digital Innovation, East Metropolitan Health Service, Perth, Australia. Electronic address: kevin.trentino@uwa.edu.au.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sanfilippo', 'Affiliation': 'School of Population and Global Health, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Leahy', 'Affiliation': 'Department of Haematology, PathWest Laboratory Medicine, Royal Perth Hospital, Perth, Australia.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Farmer', 'Affiliation': 'Medical School and Division of Surgery, University of Western Australia, Perth, Australia; School of Health Sciences and Graduate Studies, Curtin University, Perth, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Gilfillan', 'Affiliation': 'Department of Cardiothoracic Surgery, Fiona Stanley Hospital, Perth, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Murray', 'Affiliation': 'School of Population and Global Health, University of Western Australia, Perth, Australia.'}]",Chest,['10.1016/j.chest.2020.01.004']
929,18166179,Clomiphene citrate or anastrozole for ovulation induction in women with polycystic ovary syndrome? A prospective controlled trial.,"OBJECTIVE


To compare the effects of anastrozole (1 mg) and clomiphene citrate (CC; 100 mg) used for ovulation induction in women with polycystic ovary syndrome.
DESIGN


Prospective controlled trial.
SETTING


University teaching hospital and private-practice setting.
PATIENT(S)


The study comprised a total of 216 infertile women (469 cycles) with polycystic ovary syndrome.
INTERVENTION(S)


Patients received anastrozole (1 mg/d; 115 patients, 243 cycles) for 5 days, starting on day 3 of menses. A matched historical group of patients with polycystic ovary syndrome who were treated with CC (100 mg/d; 101 patients, 226 cycles) was used as a control group. Timed intercourse was advised 24-36 hours after hCG injection.
MAIN OUTCOME MEASURE(S)


Number of follicles, serum E(2), serum P, endometrial thickness, and pregnancy and miscarriage rates.
RESULT(S)


The mean age, parity, and duration of infertility in both groups were similar, but statistically significantly more polycystic ovaries were found in the anastrozole group (odds ratio = 2.44; 95% confidence interval = 1.19-5.02). The total numbers of follicles were significantly higher in the CC group (3.8 +/- 0.6 vs. 3.4 +/- 0.5). Endometrial thickness at the time of hCG administration was significantly greater in the anastrozole group (10.1 +/- 0.22 mm vs. 8.2 +/- 0.69 mm). The duration of stimulation was similar in the two groups. Ovulation occurred in 165 (67.9%) of 243 cycles in the anastrozole group and in 150 (68.6%) of 226 cycles in the CC group without significant difference. Serum P was significantly higher in the CC group (7.1 +/- 1.11 vs. 8.1 +/- 0.88 ng/mL). The pregnancy and miscarriage rates were similar in the two groups.
CONCLUSION(S)


Anastrozole was associated with significantly fewer mature and growing follicles, thicker endometrium, and slightly higher pregnancy rate. Anastrozole may be helpful in situations in which multiple pregnancy is not desirable or the risk of ovarian hyperstimulation syndrome is high.",2009,"The pregnancy and miscarriage rates were similar in the two groups.
","['patients with polycystic ovary syndrome', 'University teaching hospital and private-practice setting', 'women with polycystic ovary syndrome', '216 infertile women (469 cycles) with polycystic ovary syndrome']","['CC', 'Anastrozole', 'clomiphene citrate (CC', 'Clomiphene citrate or anastrozole', 'anastrozole']","['mean age, parity, and duration of infertility', 'Ovulation', 'Timed intercourse', 'mature and growing follicles, thicker endometrium', 'total numbers of follicles', 'polycystic ovaries', 'Number of follicles, serum E(2), serum P, endometrial thickness, and pregnancy and miscarriage rates', 'Serum P', 'pregnancy and miscarriage rates', 'pregnancy rate', 'Endometrial thickness', 'duration of stimulation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}]","[{'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}, {'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C1280412', 'cui_str': 'Thick (qualifier value)'}, {'cui': 'C0014180', 'cui_str': 'Endometrium'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]",216.0,0.138802,"The pregnancy and miscarriage rates were similar in the two groups.
","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Badawy', 'Affiliation': 'Department of Obstetrics and Gynecology, Mansoura University, Mansoura, Egypt. Electronic address: ambadawy@yahoo.com.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Abdel Aal', 'Affiliation': 'Department of Clinical Pathology, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abulatta', 'Affiliation': 'Department of Radiology, Mansoura University, Mansoura, Egypt.'}]",Fertility and sterility,['10.1016/j.fertnstert.2007.08.034']
930,32427723,Smartphone App and Carbon Monoxide Self-Monitoring Support for Smoking Cessation: A Randomized Controlled Trial Nested into the Swiss HIV Cohort Study.,,2020,,"['smoking cessation', 'Swiss HIV Cohort Study']",['Smartphone app and carbon monoxide self-monitoring support'],[],"[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",[],,0.0705271,,"[{'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Gryaznov', 'Affiliation': 'Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Chammartin', 'Affiliation': 'Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Stoeckle', 'Affiliation': 'Division of Infectious Diseases and Hospital Hygiene University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Anagnostopoulos', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Dominique Laurent', 'Initials': 'DL', 'LastName': 'Braun', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Hansjakob', 'Initials': 'H', 'LastName': 'Furrer', 'Affiliation': 'Department of Infectious Diseases, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Noémie', 'Initials': 'N', 'LastName': 'Boillat-Blanco', 'Affiliation': 'Infectious Diseases Service, University Hospital of Lausanne, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Enos', 'Initials': 'E', 'LastName': 'Bernasconi', 'Affiliation': 'Division of Infectious Diseases, Ospedale Regionale di Lugano-Civico e Italiano, Lugano, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schmid', 'Affiliation': 'Division of Infectious Diseases and Hospital Hygiene, Kantonsspital St. Gallen, St.Gallen, Switzerland.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Nordmann', 'Affiliation': 'Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Heiner C', 'Initials': 'HC', 'LastName': 'Bucher', 'Affiliation': 'Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, University of Basel, Basel, Switzerland.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002396']
931,31521794,"Evaluating the Effects of Acupuncture Using a Dental Pain Model in Healthy Subjects - A Randomized, Cross-Over Trial.","Acupuncture is a complementary and nonpharmacological intervention that can be effective for the management of chronic pain in addition to or instead of medication. Various animal models for neuropathic pain, inflammatory pain, cancer-related pain, and visceral pain already exist in acupuncture research. We used a newly validated human pain model and examined whether acupuncture can influence experimentally induced dental pain. For this study, we compared the impact of manual acupuncture (real acupuncture), manual stimulation of a needle inserted at nonacupuncture points (sham acupuncture) and no acupuncture on experimentally induced dental pain in 35 healthy men who were randomized to different sequences of all 3 interventions in a within-subject design. BORG CR10 pain ratings and autonomic responses (electrodermal activity and heart rate variability) were investigated. An initial mixed model with repeated measures included preintervention pain ratings and the trial sequence as covariates. The results showed that acupuncture was effective in reducing pain intensity when compared to no acupuncture (β = -.708, P = .002), corresponding to a medium Cohen's d effect size of .56. The comparison to the sham acupuncture revealed no statistically significant difference. No differences in autonomic responses between real and sham acupuncture were found during the intervention procedures. PERSPECTIVE: This study established a dental pain model for acupuncture research and provided evidence that experimentally induced dental pain can be influenced by either real acupuncture or manual stimulation of needles at nonacupuncture points. The data do not support that acupoint specificity is a significant factor in reducing experimental pain.",2020,"The results showed that acupuncture was effective in reducing pain intensity when compared to no acupuncture (β =-0.708, p = 0.002), corresponding to a medium Cohen's d effect size of 0.56.","['healthy subjects', 'thirty-five healthy men']","['manual acupuncture (real acupuncture), manual stimulation of a needle inserted at non-acupuncture points (sham acupuncture) and no acupuncture', 'acupuncture', 'Acupuncture']","['BORG CR10 pain ratings and autonomic responses (electrodermal activity and heart rate variability', 'preintervention pain ratings', 'autonomic responses', 'pain intensity', 'dental pain']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}]",35.0,0.186861,"The results showed that acupuncture was effective in reducing pain intensity when compared to no acupuncture (β =-0.708, p = 0.002), corresponding to a medium Cohen's d effect size of 0.56.","[{'ForeName': 'Nuno M P', 'Initials': 'NMP', 'LastName': 'de Matos', 'Affiliation': 'Institute for Complementary and Integrative Medicine, University of Zurich and University Hospital Zurich, Zurich, Switzerland; Clinic of Cranio-Maxillofacial and Oral Surgery, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pach', 'Affiliation': 'Institute for Complementary and Integrative Medicine, University of Zurich and University Hospital Zurich, Zurich, Switzerland; Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute for Social Medicine, Epidemiology and Health Economics, Berlin, Germany. Electronic address: daniel.pach@uzh.ch.'}, {'ForeName': 'Jing Jing', 'Initials': 'JJ', 'LastName': 'Xing', 'Affiliation': 'First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Barth', 'Affiliation': 'Institute for Complementary and Integrative Medicine, University of Zurich and University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Lara Elena', 'Initials': 'LE', 'LastName': 'Beyer', 'Affiliation': 'Institute for Complementary and Integrative Medicine, University of Zurich and University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Xuemin', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Institute for Complementary and Integrative Medicine, University of Zurich and University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kern', 'Affiliation': 'Institute for Complementary and Integrative Medicine, University of Zurich and University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Nenad', 'Initials': 'N', 'LastName': 'Lukic', 'Affiliation': 'Clinic of Cranio-Maxillofacial and Oral Surgery, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Dominik A', 'Initials': 'DA', 'LastName': 'Ettlin', 'Affiliation': 'Clinic of Cranio-Maxillofacial and Oral Surgery, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Brügger', 'Affiliation': 'Clinic of Cranio-Maxillofacial and Oral Surgery, Center of Dental Medicine, University of Zurich, Zurich, Switzerland; Institute for Biomedical Engineering, ETH Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Claudia M', 'Initials': 'CM', 'LastName': 'Witt', 'Affiliation': 'Institute for Complementary and Integrative Medicine, University of Zurich and University Hospital Zurich, Zurich, Switzerland; Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute for Social Medicine, Epidemiology and Health Economics, Berlin, Germany; Center for Integrative Medicine, University of Maryland School of Medicine Baltimore, Baltimore, Maryland.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.08.013']
932,31521520,Comparing effectiveness of polydeoxyribonucleotide injection and corticosteroid injection in plantar fasciitis treatment: A prospective randomized clinical study.,"BACKGROUND


This study aimed to compare the efficacy and safety of polydeoxyribonucleotide (PDRN) injection and corticosteroid injection for plantar fasciitis.
METHODS


This study included 44 patients with plantar fasciitis, randomly allocated to the PDRN and corticosteroid groups. Evaluation using the visual analogue scale (VAS) pain score and Manchester-Oxford foot questionnaire (MOXFQ) was conducted at baseline, 1, 2, 6weeks and 6months. The thickness and echogenicity of the plantar fascia in ultrasonography and complications were recorded.
RESULTS


Corticosteroid injection elicited more pain relief than did PDRN injection at 2 (p=0.010) and 6weeks (p=0.016); however, it showed no superiority at 6months (p=0.523). MOXFQ showed similar outcomes. The thickness and echogenicity did not differ between groups and no complications were reported in either group.
CONCLUSIONS


We demonstrated that PDRN injection could be an effective and safe option for plantar fasciitis and was comparable to corticosteroid injection after 6months follow up.
LEVEL OF EVIDENCE


II, comparative study.",2020,"RESULTS


Corticosteroid injection elicited more pain relief than did PDRN injection at 2 (p=0.010) and 6weeks (p=0.016); however, it showed no superiority at 6months (p=0.523).","['plantar fasciitis treatment', '44 patients with plantar fasciitis']","['polydeoxyribonucleotide (PDRN) injection and corticosteroid injection', 'polydeoxyribonucleotide injection and corticosteroid injection', 'MOXFQ', 'PDRN and corticosteroid', 'PDRN injection']","['effective and safe option for plantar fasciitis', 'pain relief', 'visual analogue scale (VAS) pain score and Manchester-Oxford foot questionnaire (MOXFQ', 'thickness and echogenicity', 'thickness and echogenicity of the plantar fascia in ultrasonography and complications']","[{'cui': 'C0149756', 'cui_str': ""Policeman's Heel""}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0032468', 'cui_str': 'Polydeoxyribonucleotides'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0149756', 'cui_str': ""Policeman's Heel""}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",44.0,0.0362363,"RESULTS


Corticosteroid injection elicited more pain relief than did PDRN injection at 2 (p=0.010) and 6weeks (p=0.016); however, it showed no superiority at 6months (p=0.523).","[{'ForeName': 'Dong-Oh', 'Initials': 'DO', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopedic Surgery, Myongji Hospital, Hanyang University College of Medicine, 697-24 Hwajung-dong, Deokyang-gu, Goyang-si, Gyeonggi-do 10475, Republic of Korea. Electronic address: ronaki@naver.com.'}, {'ForeName': 'Jeong-Hyun', 'Initials': 'JH', 'LastName': 'Yoo', 'Affiliation': 'Department of Orthopedic Surgery, Myongji Hospital, Hanyang University College of Medicine, 697-24 Hwajung-dong, Deokyang-gu, Goyang-si, Gyeonggi-do 10475, Republic of Korea. Electronic address: yjh89331@mjh.or.kr.'}, {'ForeName': 'Hyung-In', 'Initials': 'HI', 'LastName': 'Cho', 'Affiliation': 'Department of Orthopedic Surgery, Myongji Hospital, Hanyang University College of Medicine, 697-24 Hwajung-dong, Deokyang-gu, Goyang-si, Gyeonggi-do 10475, Republic of Korea. Electronic address: 90candy-eye@hanmail.net.'}, {'ForeName': 'Soonghwan', 'Initials': 'S', 'LastName': 'Cho', 'Affiliation': 'Department of Orthopedic Surgery, Myongji Hospital, Hanyang University College of Medicine, 697-24 Hwajung-dong, Deokyang-gu, Goyang-si, Gyeonggi-do 10475, Republic of Korea. Electronic address: plushyy@naver.com.'}, {'ForeName': 'Hyung Rae', 'Initials': 'HR', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Myongji Hospital, Hanyang University College of Medicine, 697-24 Hwajung-dong, Deokyang-gu, Goyang-si, Gyeonggi-do 10475, Republic of Korea. Electronic address: callmex@hanmail.net.'}]",Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons,['10.1016/j.fas.2019.08.005']
933,31522849,"Sustained outcomes in oral immunotherapy for peanut allergy (POISED study): a large, randomised, double-blind, placebo-controlled, phase 2 study.","BACKGROUND


Dietary avoidance is recommended for peanut allergies. We evaluated the sustained effects of peanut allergy oral immunotherapy (OIT) in a randomised long-term study in adults and children.
METHODS


In this randomised, double-blind, placebo-controlled, phase 2 study, we enrolled participants at the Sean N Parker Center for Allergy and Asthma Research at Stanford University (Stanford, CA, USA) with peanut allergy aged 7-55 years with a positive result from a double-blind, placebo-controlled, food challenge (DBPCFC; ≤500 mg of peanut protein), a positive skin-prick test (SPT) result (≥5 mm wheal diameter above the negative control), and peanut-specific immunoglobulin (Ig)E concentration of more than 4 kU/L. Participants were randomly assigned (2·4:1·4:1) in a two-by-two block design via a computerised system to be built up and maintained on 4000 mg peanut protein through to week 104 then discontinued on peanut (peanut-0 group), to be built up and maintained on 4000 mg peanut protein through to week 104 then to ingest 300 mg peanut protein daily (peanut-300 group) for 52 weeks, or to receive oat flour (placebo group). DBPCFCs to 4000 mg peanut protein were done at baseline and weeks 104, 117, 130, 143, and 156. The pharmacist assigned treatment on the basis of a randomised computer list. Peanut or placebo (oat) flour was administered orally and participants and the study team were masked throughout by use of oat flour that was similar in look and feel to the peanut flour and nose clips, as tolerated, to mask taste. The statistician was also masked. The primary endpoint was the proportion of participants who passed DBPCFCs to a cumulative dose of 4000 mg at both 104 and 117 weeks. The primary efficacy analysis was done in the intention-to-treat population. Safety was assessed in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT02103270.
FINDINGS


Between April 15, 2014, and March 2, 2016, of 152 individuals assessed, we enrolled 120 participants, who were randomly assigned to the peanut-0 (n=60), peanut-300 (n=35), and placebo groups (n=25). 21 (35%) of peanut-0 group participants and one (4%) placebo group participant passed the 4000 mg challenge at both 104 and 117 weeks (odds ratio [OR] 12·7, 95% CI 1·8-554·8; p=0·0024). Over the entire study, the most common adverse events were mild gastrointestinal symptoms, which were seen in 90 of 120 patients (50/60 in the peanut-0 group, 29/35 in the peanut-300 group, and 11/25 in the placebo group) and skin disorders, which were seen in 50/120 patients (26/60 in the peanut-0 group, 15/35 in the peanut-300 group, and 9/25 in the placebo group). Adverse events decreased over time in all groups. Two participants in the peanut groups had serious adverse events during the 3-year study. In the peanut-0 group, in which eight (13%) of 60 participants passed DBPCFCs at week 156, higher baseline peanut-specific IgG4 to IgE ratio and lower Ara h 2 IgE and basophil activation responses were associated with sustained unresponsiveness. No treatment-related deaths occurred.
INTERPRETATION


Our study suggests that peanut OIT could desensitise individuals with peanut allergy to 4000 mg peanut protein but discontinuation, or even reduction to 300 mg daily, could increase the likelihood of regaining clinical reactivity to peanut. Since baseline blood tests correlated with week 117 treatment outcomes, this study might aid in optimal patient selection for this therapy.
FUNDING


National Institute of Allergy and Infectious Diseases.",2019,"Our study suggests that peanut OIT could desensitise individuals with peanut allergy to 4000 mg peanut protein but discontinuation, or even reduction to 300 mg daily, could increase the likelihood of regaining clinical reactivity to peanut.","['enrolled participants at the Sean N Parker Center for Allergy and Asthma Research at Stanford University (Stanford, CA, USA) with peanut allergy aged 7-55 years with a positive result from a double-blind, placebo-controlled, food challenge (DBPCFC; ≤500 mg of peanut protein), a positive skin-prick test (SPT) result (≥5 mm wheal diameter above the negative control), and peanut-specific immunoglobulin (Ig)E concentration of more than 4 kU/L. Participants', 'adults and children', 'Between April 15, 2014, and March 2, 2016, of 152 individuals assessed, we enrolled 120 participants']","['oat flour (placebo', 'oral immunotherapy', 'placebo', 'DBPCFCs', 'Peanut or placebo (oat) flour', 'peanut allergy oral immunotherapy (OIT']","['proportion of participants who passed DBPCFCs', 'Safety', 'Adverse events', 'skin disorders', 'serious adverse events', 'baseline peanut-specific IgG4 to IgE ratio and lower Ara h 2 IgE and basophil activation responses']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0035168'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0559470', 'cui_str': 'Groundnut Hypersensitivity'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0430561', 'cui_str': 'Prick test (procedure)'}, {'cui': 'C0221232', 'cui_str': 'Wheal'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1270751', 'cui_str': 'Arachis hypogaea specific immunoglobulin E (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0028753', 'cui_str': 'Oats (substance)'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0559470', 'cui_str': 'Groundnut Hypersensitivity'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037274', 'cui_str': 'Dermatoses'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020860', 'cui_str': 'IgG4'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0063241', 'cui_str': 'hypoxanthine arabinoside'}, {'cui': 'C4316898', 'cui_str': 'Basophil, segmented (cell)'}]",120.0,0.566722,"Our study suggests that peanut OIT could desensitise individuals with peanut allergy to 4000 mg peanut protein but discontinuation, or even reduction to 300 mg daily, could increase the likelihood of regaining clinical reactivity to peanut.","[{'ForeName': 'R Sharon', 'Initials': 'RS', 'LastName': 'Chinthrajah', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Purington', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Medicine, Stanford University, Stanford, CA, USA; Quantitative Sciences Unit, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Andorf', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Long', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': ""O'Laughlin"", 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Shu Chen', 'Initials': 'SC', 'LastName': 'Lyu', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Monali', 'Initials': 'M', 'LastName': 'Manohar', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Boyd', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Pathology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Tibshirani', 'Affiliation': 'Department of Biomedical Data Sciences, Stanford University, Stanford, CA, USA; Department of Statistics, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Holden', 'Initials': 'H', 'LastName': 'Maecker', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Microbiology and Immunology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Marshall', 'Initials': 'M', 'LastName': 'Plaut', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Mukai', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Pathology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Mindy', 'Initials': 'M', 'LastName': 'Tsai', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Pathology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'Quantitative Sciences Unit, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Galli', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Pathology, Stanford University, Stanford, CA, USA; Department of Microbiology and Immunology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Kari C', 'Initials': 'KC', 'LastName': 'Nadeau', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Medicine, Stanford University, Stanford, CA, USA. Electronic address: knadeau@stanford.edu.'}]","Lancet (London, England)",['10.1016/S0140-6736(19)31793-3']
934,32429063,Probiotic NVP-1703 Alleviates Allergic Rhinitis by Inducing IL-10 Expression: A Four-week Clinical Trial.,"Although several recent studies reported that probiotics might be beneficial for allergic rhinitis (AR), the effect of probiotics on AR is not consistent and have not been reproduced between studies. We aimed to determine the efficacy and safety of probiotic NVP-1703, a mixture of  Bifidobacterium longum  and  Lactobacillus plantarum , in subjects with perennial AR. Adult subjects with perennial AR received either NVP-1703 ( n  = 47) or placebo ( n  = 48) for four weeks. Total nasal symptom scores (TNSS), rhinitis control assessment test (RCAT), blood eosinophil count, allergen-specific IgE, and immunological parameters in serum and urine were compared at baseline and after four weeks. TNSS changes from baseline at weeks 1, 3, and 4 were significant between the NVP-1703 and placebo groups ( p  = 0.033, 0.031, and 0.029, respectively). RCAT score showed significant differences between the NVP-1703 and placebo groups ( p  = 0.049) at week 4.  Dermatophagoides farinae -specific IgE levels and serum IL-10 levels were significantly different between the NVP-1703 and placebo groups ( p  = 0.033 and  p  = 0.047, respectively). IL-10/IL-4 and IL-10/IL-13 ratios were different between the NVP-1703 and placebo groups at week 4 ( p  = 0.046 and 0.018, respectively). NVP-1703 treatment reduced urinary prostaglandin F 2α  and leukotriene E 4  levels ( p  > 0.05). Therefore, NVP-1703 can be treatment option for perennial AR.",2020,NVP-1703 treatment reduced urinary prostaglandin F 2α  and leukotriene E 4  levels ( p  > 0.05).,"['subjects with perennial AR', 'Alleviates Allergic Rhinitis by Inducing IL-10 Expression', 'Adult subjects with perennial AR']","['Probiotic NVP-1703', 'probiotic NVP-1703, a mixture of  Bifidobacterium longum  and  Lactobacillus plantarum', 'NVP-1703', 'NVP-1703 and placebo', 'placebo']","['RCAT score', 'Dermatophagoides farinae -specific IgE levels and serum IL-10 levels', 'TNSS changes', 'Total nasal symptom scores (TNSS), rhinitis control assessment test (RCAT), blood eosinophil count, allergen-specific IgE, and immunological parameters in serum and urine', 'IL-10/IL-4 and IL-10/IL-13 ratios', 'urinary prostaglandin F 2α  and leukotriene E 4  levels']","[{'cui': 'C0035457', 'cui_str': 'Perennial allergic rhinitis'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0314977', 'cui_str': 'Bifidobacterium longum'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0323677', 'cui_str': 'Dermatophagoides farinae'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0443736', 'cui_str': 'Allergen specific immunoglobulin E'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0033561', 'cui_str': 'F series prostaglandin'}, {'cui': 'C0125644', 'cui_str': 'LTE4'}]",,0.0815145,NVP-1703 treatment reduced urinary prostaglandin F 2α  and leukotriene E 4  levels ( p  > 0.05).,"[{'ForeName': 'Min-Gyu', 'Initials': 'MG', 'LastName': 'Kang', 'Affiliation': 'Department of Allergy and Clinical Immunology, Chungbuk National University Hospital, Cheongju 28644, Korea.'}, {'ForeName': 'Seung-Won', 'Initials': 'SW', 'LastName': 'Han', 'Affiliation': 'PB Business Department, Navipharm Inc., Suwon 16209, Korea.'}, {'ForeName': 'Hye-Ryun', 'Initials': 'HR', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, Division of Allergy and Clinical Immunology, Seoul National University Hospital, Seoul 03080, Korea.'}, {'ForeName': 'Seok-Jin', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Hallym University Dongtan Sacred Heart Hospital, Hwaseong 18450, Korea.'}, {'ForeName': 'Dong-Hyun', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Neurobiota Research Center, College of Pharmacy, Kyung Hee University, Seoul 02453, Korea.'}, {'ForeName': 'Jeong-Hee', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Allergy and Clinical Immunology Research Center, Hallym University College of Medicine, Chuncheon 24252, Korea.'}]",Nutrients,['10.3390/nu12051427']
935,31955271,"Evaluation of adhesion of Streptococcus mutans, plaque accumulation on zirconia and stainless steel crowns, and surrounding gingival inflammation in primary molars: randomized controlled trial.","OBJECTIVE


To evaluate the adhesion of Streptococcus mutans to preformed zirconia and stainless steel crowns and compare plaque accumulation and gingival inflammation over a period of 1 year.
MATERIALS AND METHODS


Thirty children between 6 to 9 years with pulpectomised bilateral mandibular primary second molars were randomly divided into zirconia/stainless steel groups. Plaque was collected from the crowns using swabs at 3, 6, 9, and 12 months. Gingival and plaque index were recorded at all follow-ups. S. mutans was cultured on tryptone-yeast-cysteine-sucrose-bacitracin agar, and organisms were expressed as colony-forming units. Within-group analysis was performed using repeated measures ANOVA and between-groups using the independent T test.
RESULTS


S. mutans were found in significantly higher numbers on the stainless steel crowns as compared with zirconia crowns at all the follow-ups. Gingival inflammation and plaque index scores were also significantly higher around the stainless steel crowns as compared with zirconia at the end of 12 months follow-up.
CONCLUSION


Adhesion of S. mutans to stainless steel crowns was significantly greater when compared with zirconia, and minimal gingival inflammation and plaque accumulation was found in the tooth restored with zirconia crowns as compared with stainless steel crowns.
CLINICAL RELEVANCE


Preformed zirconia crowns prevents adhesion of S. mutans onto its surface, and reduces plaque accumulation around the crown, inflammation of surrounding gingiva compared to conventional stainless-steel crowns. Pediatric zirconia crowns could help in reducing the overall microbial density and prevalence in the oral cavity, thus reducing the caries risk in the long term.",2020,"Gingival inflammation and plaque index scores were also significantly higher around the stainless steel crowns as compared with zirconia at the end of 12 months follow-up.
","['zirconia and stainless steel crowns, and surrounding gingival inflammation in primary molars', 'Thirty children between 6 to 9\xa0years with pulpectomised bilateral mandibular primary second molars']","['zirconia and stainless steel crowns', 'zirconia/stainless steel groups']","['Gingival inflammation and plaque index scores', 'caries risk', 'Gingival and plaque index', 'plaque accumulation and gingival inflammation', 'minimal gingival inflammation and plaque accumulation', 'overall microbial density and prevalence']","[{'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0038126', 'cui_str': 'Stainless Steel'}, {'cui': 'C3853546', 'cui_str': 'Dental Crowns'}, {'cui': 'C1282914', 'cui_str': 'Surrounding (qualifier value)'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}]","[{'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0038126', 'cui_str': 'Stainless Steel'}, {'cui': 'C3853546', 'cui_str': 'Dental Crowns'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4521854', 'cui_str': 'Gingival (intended site)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",30.0,0.04469,"Gingival inflammation and plaque index scores were also significantly higher around the stainless steel crowns as compared with zirconia at the end of 12 months follow-up.
","[{'ForeName': 'Mebin George', 'Initials': 'MG', 'LastName': 'Mathew', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Saveetha Dental College, Saveetha Institute of Medical and Technical Sciences, Chennai, 600077, India. mebingmathew@gmail.com.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Samuel', 'Affiliation': 'Department of Public Health Dentistry, Saveetha Dental College, Saveetha Institute of Medical and Technical Sciences, Chennai, 600077, India.'}, {'ForeName': 'Ashu Jagdish', 'Initials': 'AJ', 'LastName': 'Soni', 'Affiliation': ""Dr. Ashu's Dental Clinic, Vadodara, 390024, India.""}, {'ForeName': 'Korishettar Basavaraj', 'Initials': 'KB', 'LastName': 'Roopa', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, College of Dental Sciences, Davangere, 577004, India.'}]",Clinical oral investigations,['10.1007/s00784-020-03204-9']
936,32429553,Effects of Cognitive Behavioral Group Program for Mental Health Promotion of University Students.,"This study aimed to explore the effects of a group cognitive behavioral program on depression, self-esteem, and interpersonal relations among undergraduate students. A non-equivalent control group pretest-posttest design was used. A convenient sample of 37 undergraduates (18 in the experimental group and 19 in the control group) at K university located in Changwon, South Korea was used. Data were collected from February 4, 2019 to June 18, 2019. The experimental group received eight sessions of the program, which were scheduled twice a week, with each session lasting 90 min. Collected data were analyzed using a chi-square test, Fisher's exact test, independent  t -test, and repeated measures ANOVA by SPSS/WIN 23.0 (SPSS, Inc., Chicago, IL, USA). The interaction of group and time was significant, indicating that the experimental group showed an improvement in depression, self-esteem, and personal relationship compared to the control group. A significant group by time interaction for depression, self-esteem, and personal relationship was also found between the two groups. The study results revealed that the group cognitive behavioral program was effective in reducing depression and improving self-esteem and interpersonal relation. Therefore, the group cognitive behavioral program can be used for promoting the mental health of students as well as for preventing depression in a university setting.",2020,"A significant group by time interaction for depression, self-esteem, and personal relationship was also found between the two groups.","['37 undergraduates (18 in the experimental group and 19 in the control group) at K university located in Changwon, South Korea was used', 'undergraduate students', 'Mental Health Promotion of University Students', 'Data were collected from February 4, 2019 to June 18, 2019']","['Cognitive Behavioral Group Program', 'group cognitive behavioral program']","['depression and improving self-esteem and interpersonal relation', 'time interaction for depression, self-esteem, and personal relationship', 'depression, self-esteem, and interpersonal relations', 'depression, self-esteem, and personal relationship']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0184645', 'cui_str': 'Mental health promotion'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.0129976,"A significant group by time interaction for depression, self-esteem, and personal relationship was also found between the two groups.","[{'ForeName': 'Soojung', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Kyungnam University, 7, Gyeongnamdaehak-ro, Masanhappo-gu, Changwon-si, Gyeongnam 51767, Korea.'}, {'ForeName': 'Eunjoo', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Kyungnam University, 7, Gyeongnamdaehak-ro, Masanhappo-gu, Changwon-si, Gyeongnam 51767, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17103500']
937,17681303,Local injury to the endometrium in controlled ovarian hyperstimulation cycles improves implantation rates.,"OBJECTIVE


To explore the possibility that local injury to the endometrium in controlled ovarian hyperstimulation cycle improves the incidence of embryo implantation and to analyze the gene expression profile in the endometria of pregnant and nonpregnant patients in in vitro fertilization/embryo transfer (IVF-ET).
DESIGN


Prospective study.
SETTING


A clinical assisted reproductive center of a university hospital.
PATIENT(S)


Women undergoing fresh IVF-ET cycles (n = 121), treated with a long protocol for controlled ovarian hyperstimulation, whose endometrium were diagnosed by B-ultrasound showing irregular echo.
INTERVENTION(S)


Local injury to the endometrium of 60 patients in controlled ovarian hyperstimulation cycle, who were randomly selected from a total of 121 patients. Seven endometrial biopsies samples from day 10 were analyzed by Affymetrix U133 plus 2.0 gene chip.
MAIN OUTCOME MEASURE(S)


Outcomes of IVF-ET and gene expression assayed by gene chip technology.
RESULT(S)


Transfer of the same number of embryos (135 in the experimental and control patients, respectively) resulted in rates of implantation (33.33% vs. 17.78%), clinical pregnancy (48.33% vs. 27.86%), and ongoing or live births per ET (41.67% vs. 22.96%) that were higher in the experimental group compared with controls. Statistically significant differences of the expression level of 218 genes (41 up-regulated and 177 down-regulated) were detected in the endometrial biopsy samples from clinical pregnant patients and nonpregnant patients.
CONCLUSION(S)


The results suggested local injury to the endometrium during a COH cycle improved the rates of embryo implantation, clinical pregnancy and live birth in ART. We also demonstrated a statistically significant difference in the messenger RNA (mRNA) expression profiles in the endometrium of pregnant and nonpregnant patients. Further studies on the genes identified herein will assist in predicting implantation competence.",2008,"Statistically significant differences of the expression level of 218 genes (41 up-regulated and 177 down-regulated) were detected in the endometrial biopsy samples from clinical pregnant patients and nonpregnant patients.
","['60 patients in controlled ovarian hyperstimulation cycle, who were randomly selected from a total of 121 patients', '\n\n\nWomen undergoing fresh IVF-ET cycles (n = 121), treated with a long protocol for controlled ovarian hyperstimulation, whose endometrium were diagnosed by B-ultrasound showing irregular echo', 'A clinical assisted reproductive center of a university hospital', 'pregnant and nonpregnant patients in in vitro fertilization/embryo transfer (IVF-ET']",[],"['rates of embryo implantation, clinical pregnancy and live birth in ART', 'messenger RNA (mRNA) expression profiles', 'clinical pregnancy', 'implantation rates', 'rates of implantation', 'IVF-ET and gene expression assayed by gene chip technology']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3160882', 'cui_str': 'Controlled ovarian hyperstimulation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0014180', 'cui_str': 'Endometrium'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0205271', 'cui_str': 'Irregular (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}]",[],"[{'cui': 'C0029976', 'cui_str': 'Ovum Implantation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0872345', 'cui_str': 'Gene Chips'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]",121.0,0.066775,"Statistically significant differences of the expression level of 218 genes (41 up-regulated and 177 down-regulated) were detected in the endometrial biopsy samples from clinical pregnant patients and nonpregnant patients.
","[{'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': ""Department of Reproductive Medicine, Peking University Shenzhen Hospital, Medical Central of Peking University and Hong Kong Science and Technology University, Shenzhen, Guangdong, People's Republic of China.""}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': ""Department of Reproductive Medicine, Peking University Shenzhen Hospital, Medical Central of Peking University and Hong Kong Science and Technology University, Shenzhen, Guangdong, People's Republic of China. Electronic address: lrivf@163.com.""}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ""Department of Reproductive Medicine, Peking University Shenzhen Hospital, Medical Central of Peking University and Hong Kong Science and Technology University, Shenzhen, Guangdong, People's Republic of China.""}, {'ForeName': 'Hai-Xiong', 'Initials': 'HX', 'LastName': 'Huang', 'Affiliation': ""Department of Reproductive Medicine, Peking University Shenzhen Hospital, Medical Central of Peking University and Hong Kong Science and Technology University, Shenzhen, Guangdong, People's Republic of China.""}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zhong', 'Affiliation': ""Department of Reproductive Medicine, Peking University Shenzhen Hospital, Medical Central of Peking University and Hong Kong Science and Technology University, Shenzhen, Guangdong, People's Republic of China.""}]",Fertility and sterility,['10.1016/j.fertnstert.2007.05.064']
938,32428586,"Integrating an online weight management program with population health management in primary care: Design, methods, and baseline data from the PROPS randomized controlled trial (Partnerships for Reducing Overweight and Obesity with Patient-centered Strategies).","BACKGROUND


Scalable, low-cost weight management strategies are needed in primary care. We conducted a pragmatic, cluster-randomized controlled trial to examine the effectiveness of an online weight management program integrated with population health management support.
METHODS


We adapted an online weight management program and integrated it with population health management support in 15 primary care practices (24 clinics). We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI). Eligible participants had to be ages 20 to 70 and have a recent primary care visit, body mass index (BMI) ≥ 27 and < 40 kg/m 2 , and a diagnosis of hypertension or type 2 diabetes. Participants attended routine visits and completed surveys over 18 months. The primary outcome is absolute weight change at 12 months (± 90 days) after enrollment, calculated from weights measured at primary care visits and recorded in the electronic health record.
RESULTS


We enrolled 840 participants between July 2016 and August 2017 (326 UC, 216 OP, and 298 CI.) At enrollment, participants' mean age was 59.3 years, their mean weight was 203.1 pounds, and their mean BMI was 32.5 kg/m 2 ; 60% of participants were female, 76.8% were white, 96.4% had hypertension, and 24.4% had type 2 diabetes.
CONCLUSION


It is feasible to adapt an online weight management program and integrate it with population health management support in primary care. The results of this trial will provide valuable information about the effectiveness of these strategies in primary care settings. ClinicalTrials.govregistration number:NCT02656693.",2020,"We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI).","['Eligible participants had to be ages 20 to 70 and have a recent primary care visit, body mass index (BMI)\u202f≥\u202f27 and\u202f<\u202f40\u202fkg/m 2 , and a diagnosis of hypertension or type 2 diabetes', '15 primary care practices (24 clinics', ""At enrollment, participants' mean age was 59.3\u202fyears, their mean weight was 203.1 pounds, and their mean BMI was 32.5\u202fkg/m 2 ; 60% of participants were female, 76% were white, 96.4% had hypertension, and 24.4% had type 2 diabetes"", 'We enrolled 840 participants between July 2016 and August 2017 (326 UC, 216 OP, and 298 CI']","['online weight management program with population health management', 'online weight management program and integrated it with population health management support', 'usual care (UC), online program alone (OP), or combined intervention (CI', 'online weight management program integrated with population health management support']","['absolute weight change at 12\u202fmonths (± 90\u202fdays) after enrollment, calculated from weights measured at primary care visits and recorded in the electronic health record']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439219', 'cui_str': 'lb'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C4704688', 'cui_str': 'Population Health Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0043101', 'cui_str': 'Weights and Measures'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}]",840.0,0.0950447,"We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI).","[{'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Baer', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America. Electronic address: hbaer@bwh.harvard.edu.""}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'De La Cruz', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Ronen', 'Initials': 'R', 'LastName': 'Rozenblum', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Nyryan V', 'Initials': 'NV', 'LastName': 'Nolido', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America.""}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Metzler', 'Affiliation': ""Department of Nutrition, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Block', 'Affiliation': ""Harvard Medical School, Boston, MA, United States of America; Department of Population Medicine, Harvard Pilgrim Healthcare Institute, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Florencia', 'Initials': 'F', 'LastName': 'Halperin', 'Affiliation': ""Harvard Medical School, Boston, MA, United States of America; Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'McManus', 'Affiliation': ""Department of Nutrition, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Louis J', 'Initials': 'LJ', 'LastName': 'Aronne', 'Affiliation': 'BMIQ Professionals Program, Intellihealth/BMIQ, United States of America; Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine, New York, NY, United States of America.'}, {'ForeName': 'Guadalupe', 'Initials': 'G', 'LastName': 'Minero', 'Affiliation': 'BMIQ Professionals Program, Intellihealth/BMIQ, United States of America.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Bates', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106026']
939,31844937,Opposing sex-dependent effects of oxytocin on the perception of gaze direction.,"BACKGROUND


Gaze direction is an important cue of the eye region. Previous studies have revealed that oxytocin (OXT) increases orienting to the eye region of face. However, little has been known about the effect of OXT in men and women on the perception of gaze direction particularly when associated with different emotions.
OBJECTIVES


We investigated how oxytocin would affect gaze direction judgments for threatening, angry, and neutral facial expressions and whether this effect would be modulated by observers' sex.
METHODS


We used the cone of direct gaze (CoDG) task. Participants were required to judge the gaze direction of face between directed and averted gaze.
RESULTS


Results showed opposing sex-dependent effects of OXT such that OXT, as compared with placebo, tended to decrease the CoDG in men but increase it in women. The CoDG was marginally wider in men than in women in the placebo condition, and however, this difference was abolished following OXT treatment. We also found that the perception of gaze direction varied as a function of emotional expression such that the CoDG for angry and neutral faces was wider than that for fearful faces and the CoDG for angry faces was marginally wider than that for neutral ones. However, there was no significant interaction between treatment and facial expression.
CONCLUSIONS


Our findings provide the first evidence for sex-dependent effects of OXT on gaze direction perception, suggesting that OXT attenuates the self-referential judgment of gaze directions of others in men and enhances it in women despite differentiated emotions of faces.",2020,"The CoDG was marginally wider in men than in women in the placebo condition, and however, this difference was abolished following OXT treatment.",[],"['oxytocin (OXT', 'placebo', 'OXT', 'direct gaze (CoDG) task', 'oxytocin']","['gaze direction judgments for threatening, angry, and neutral facial expressions', 'gaze direction of face between directed and averted gaze', 'perception of gaze direction']",[],"[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0553544', 'cui_str': 'Gaze (finding)'}]","[{'cui': 'C1455770', 'cui_str': 'Gaze directions'}, {'cui': 'C0022423', 'cui_str': 'Judgment'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0015457', 'cui_str': 'Facial Expression'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0553544', 'cui_str': 'Gaze (finding)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0651216,"The CoDG was marginally wider in men than in women in the placebo condition, and however, this difference was abolished following OXT treatment.","[{'ForeName': 'Yahuan', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': ""Institute for Brain and Psychological Sciences, Sichuan Normal University, Chengdu, 610068, People's Republic of China.""}, {'ForeName': 'Jinmeng', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Institute for Brain and Psychological Sciences, Sichuan Normal University, Chengdu, 610068, People's Republic of China.""}, {'ForeName': 'Zhonghua', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': ""Institute for Brain and Psychological Sciences, Sichuan Normal University, Chengdu, 610068, People's Republic of China. huzhonghua2000@163.com.""}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': ""School of Foreign Languages, University of Electronic Science and Technology of China, Chengdu, 611731, People's Republic of China. hohxil@sina.com.""}]",Psychopharmacology,['10.1007/s00213-019-05423-9']
940,31844967,"The effect of hesperidin supplementation on metabolic profiles in patients with metabolic syndrome: a randomized, double-blind, placebo-controlled clinical trial.","PURPOSE


Hesperidin as an antioxidant flavonoid exerts anti-adipogenic, anti-inflammatory, anti-oxidant and anti-hypercholesterolemic effects. Besides, the increasing prevalence of metabolic syndrome (MetS) and its allied complications, on the one hand, and the willingness of individuals to use natural products for curing their diseases, on the other hand, led to the design of this study to evaluate the efficacy of hesperidin in normalizing the metabolic abnormalities in patients with MetS.
METHODS


In this clinical trial with a parallel-group design, 49 patients with MetS received either 500-mg hesperidin or placebo, twice daily, for 12 weeks. Number of participants with treated MetS was considered as a primary end point. Anthropometric parameters, dietary intake, physical activity, lipid profile, glucose homeostasis parameter, tumor necrosis factor alpha (TNF-α), high-sensitivity C-reactive protein (hs-CRP) were assessed at the beginning and at the end of the study. This trial is registered at clinicaltrials.gov as NCT03734874.
RESULTS


Compared with the placebo group, hesperidin decreased fasting glucose level (- 6.07 vs. - 13.32 mg/dL, P = 0.043), triglyceride (- 8.83 vs. - 49.09 mg/dL, P = 0.049), systolic blood pressure (- 0.58 vs. - 2.68 mmHg, P = 0.048) and TNF-α (- 1.29 vs. - 4.44 pg/mL, P = 0.009). Based on the within-group analysis, hesperidin led to significant decrease in serum levels of glucose, insulin, triglyceride, total cholesterol, low density lipoprotein cholesterol, TNF-α and hs-CRP, while in control group only glucose and insulin significantly decreased.
CONCLUSIONS


The results indicate that hesperidin supplementation can improve metabolic abnormalities and inflammatory status in patients with MetS.",2020,"Compared with the placebo group, hesperidin decreased fasting glucose level (- 6.07 vs. - 13.32 mg/dL, P = 0.043), triglyceride (- 8.83 vs. - 49.09 ","['patients with metabolic syndrome', '49 patients with MetS received either', 'patients with MetS']","['500-mg hesperidin or placebo', 'placebo', 'hesperidin supplementation']","['systolic blood pressure', 'Anthropometric parameters, dietary intake, physical activity, lipid profile, glucose homeostasis parameter, tumor necrosis factor alpha (TNF-α), high-sensitivity C-reactive protein (hs-CRP', 'triglyceride', 'TNF-α', 'serum levels of glucose, insulin, triglyceride, total cholesterol, low density lipoprotein cholesterol, TNF-α and hs-CRP', 'metabolic profiles', 'hesperidin decreased fasting glucose level', 'metabolic abnormalities and inflammatory status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}]","[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0019392', 'cui_str': 'Hesperidin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0019392', 'cui_str': 'Hesperidin'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",49.0,0.167652,"Compared with the placebo group, hesperidin decreased fasting glucose level (- 6.07 vs. - 13.32 mg/dL, P = 0.043), triglyceride (- 8.83 vs. - 49.09 ","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Yari', 'Affiliation': 'Student Research Committee, Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Movahedian', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition Sciences and Food Technology, National Nutrition and Food Technology, Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Imani', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences (TUMS), Tehran, Iran.'}, {'ForeName': 'Seyed Moayed', 'Initials': 'SM', 'LastName': 'Alavian', 'Affiliation': 'Middle East Liver Diseases (MELD) Center, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hedayati', 'Affiliation': 'Cellular and Molecular Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Hekmatdoost', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition Sciences and Food Technology, National Nutrition and Food Technology, Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Azita.Hekmatdoost@cw.bc.ca.'}]",European journal of nutrition,['10.1007/s00394-019-02105-2']
941,32078037,"Incorrect design and analysis render conclusion unsubstantiated: comment on ""A digital movement in the world of inactive children: favourable outcomes of playing active video games in a pilot randomized trial"".",,2020,,[],[],[],[],[],[],,0.138104,,"[{'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Golzarri-Arroyo', 'Affiliation': 'School of Public Health, Indiana University - Bloomington, Bloomington, IN, USA. lgolzarr@indiana.edu.'}, {'ForeName': 'Colby J', 'Initials': 'CJ', 'LastName': 'Vorland', 'Affiliation': 'School of Public Health, Indiana University - Bloomington, Bloomington, IN, USA.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Oakes', 'Affiliation': 'School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Ethan T', 'Initials': 'ET', 'LastName': 'Hunt', 'Affiliation': 'Department of Exercise Science, Arnold School of Public Health, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Brown', 'Affiliation': 'School of Public Health, Indiana University - Bloomington, Bloomington, IN, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Allison', 'Affiliation': 'School of Public Health, Indiana University - Bloomington, Bloomington, IN, USA.'}]",European journal of pediatrics,['10.1007/s00431-020-03590-y']
942,32074616,Changes in Therapeutic Alliance and in Social Inhibition as Mediators of the Effect of the Cognitive Behavioral Analysis System of Psychotherapy: A Secondary Analysis from a Randomized Clinical Trial.,,2020,,[],['Psychotherapy'],[],[],"[{'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]",[],,0.115922,,"[{'ForeName': 'Jan Philipp', 'Initials': 'JP', 'LastName': 'Klein', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, Lübeck, Germany, philipp.klein@uksh.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Probst', 'Affiliation': 'Department for Psychotherapy and Biopsychosocial Health, Danube University Krems, Krems, Austria.'}, {'ForeName': 'Levente', 'Initials': 'L', 'LastName': 'Kriston', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Nele', 'Initials': 'N', 'LastName': 'Assmann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, Lübeck, Germany.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Bailer', 'Affiliation': 'Department of Clinical Psychology, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Eich', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, Lübeck, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schweiger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, Lübeck, Germany.'}, {'ForeName': 'Nikola Maria', 'Initials': 'NM', 'LastName': 'Stenzel', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Psychologische Hochschule Berlin, Berlin, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Wambach', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Marburg, Marburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hautzinger', 'Affiliation': 'Department of Psychology, Clinical Psychology and Psychotherapy, Eberhard Karls University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Schramm', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Freiburg, Freiburg, Germany.'}]",Psychotherapy and psychosomatics,['10.1159/000506082']
943,32127255,Exercise program and blood pressure in children: The moderating role of sedentary time.,"OBJECTIVES


The aim of the present study was to test a before-school physical activity intervention (Active-Start intervention) on blood pressure in children and examine whether sedentary time moderates the effect of the intervention on blood pressure.
DESIGN


Randomized controlled trial.
METHODS


The Active-Start intervention comprising 170 children (8-10 years old) from three public schools with low socioeconomic status in Santiago (Chile). The exercise intervention was delivered daily, before starting the first school-class (8:00-8:30 a.m.), for 8 weeks. The intervention was mainly a program of cooperative physical games at moderate-vigorous intensity. Resting systolic and diastolic blood pressure was determined from the average of two measurements at baseline and at the end of intervention. Moderate-to-vigorous physical activity and sedentary time was assessed using a GENEActiv tri-axial accelerometer prior to the program intervention.
RESULTS


The Active-Start intervention decreased blood pressure levels in children (p<0.01) but did not change relative to the control group. Johnson-Neyman analysis revealed a significant relationship between the effect of intervention on systolic blood pressure and mean arterial pressure when sedentary time was below, but not at or above, 657 and 659min per day (i.e., the effect of physical exercise disappears), respectively.
CONCLUSIONS


The effect of physical activity on blood pressure could disappear in children with excessive sedentary time, which highlights the need to reduce total levels of sedentary time in the day-to-day life of young people in and out of schools.",2020,The Active-Start intervention decreased blood pressure levels in children (p<0.01) but did not change relative to the control group.,"['170 children (8-10 years old) from three public schools with low socioeconomic status in Santiago (Chile', 'children with excessive sedentary time', 'children']","['physical activity', 'exercise intervention', 'Exercise program', 'school physical activity intervention (Active-Start intervention']","['Moderate-to-vigorous physical activity and sedentary time', 'systolic blood pressure and mean arterial pressure', 'blood pressure levels', 'blood pressure', 'Resting systolic and diastolic blood pressure']","[{'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0557800', 'cui_str': 'Public school (environment)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0008107', 'cui_str': 'Chile'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}]",170.0,0.0246919,The Active-Start intervention decreased blood pressure levels in children (p<0.01) but did not change relative to the control group.,"[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'García-Hermoso', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN), Universidad Pública de Navarra (UPNA), IdiSNA, Spain; Laboratorio de Ciencias de la Actividad Física, el Deporte y la Salud, Facultad de Ciencias Médicas, Universidad de Santiago de Chile, USACH, Chile. Electronic address: antonio.garciah@unavarra.es.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Hormazábal-Aguayo', 'Affiliation': 'Laboratorio de Ciencias de la Actividad Física, el Deporte y la Salud, Facultad de Ciencias Médicas, Universidad de Santiago de Chile, USACH, Chile.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'González-Calderón', 'Affiliation': 'Laboratorio de Ciencias de la Actividad Física, el Deporte y la Salud, Facultad de Ciencias Médicas, Universidad de Santiago de Chile, USACH, Chile.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Russell-Guzmán', 'Affiliation': 'Escuela de Pedagogía en Educación Física, Facultad de Educación, Universidad Autónoma de Chile, Chile.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Vicencio-Rojas', 'Affiliation': 'Laboratorio de Ciencias de la Actividad Física, el Deporte y la Salud, Facultad de Ciencias Médicas, Universidad de Santiago de Chile, USACH, Chile.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Chacana-Cañas', 'Affiliation': 'Laboratorio de Ciencias de la Actividad Física, el Deporte y la Salud, Facultad de Ciencias Médicas, Universidad de Santiago de Chile, USACH, Chile.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Urrutia-Reyes', 'Affiliation': 'Laboratorio de Ciencias de la Actividad Física, el Deporte y la Salud, Facultad de Ciencias Médicas, Universidad de Santiago de Chile, USACH, Chile.'}, {'ForeName': 'Robinson', 'Initials': 'R', 'LastName': 'Ramírez-Vélez', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN), Universidad Pública de Navarra (UPNA), IdiSNA, Spain; Department of Health Sciences, Public University of Navarra, CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Spain.'}, {'ForeName': 'Alicia M', 'Initials': 'AM', 'LastName': 'Alonso-Martinez', 'Affiliation': 'Department of Health Sciences, Public University of Navarra, CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Spain.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN), Universidad Pública de Navarra (UPNA), IdiSNA, Spain; Department of Health Sciences, Public University of Navarra, CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Spain.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Fernández-Vergara', 'Affiliation': 'Laboratorio de Ciencias de la Actividad Física, el Deporte y la Salud, Facultad de Ciencias Médicas, Universidad de Santiago de Chile, USACH, Chile.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.02.012']
944,32434761,A School-Based Intervention for Mental Illness Stigma: A Cluster Randomized Trial.,"OBJECTIVES


To determine the effectiveness of a school-based curriculum, Eliminating the Stigma of Differences (ESD), in improving attitudinal and/or behavioral contexts regarding mental illness in schools and increasing the likelihood that youth seek treatment for mental health problems when needed.
METHODS


We conducted a cluster randomized trial in sixth-grade classes from 14 schools in 2011 and 2012 with follow-up at 6-month intervals through 24 months (2012-2015). Using a fully crossed 2 × 2 × 2 factorial design, we compared ESD to a no-intervention control and to 2 comparator interventions: (1) contact with 2 young adults with a history of mental illness and (2) exposure to antistigma printed materials. We implemented interventions in classrooms in an ethnically and socioeconomically diverse school district. There were 416 youth who participated in the follow-up, and 312 (75%) of these participated for the full 2 years. Outcome measures were knowledge and positive attitudes, social distance from peers with mental illness, and mental health treatment seeking.
RESULTS


Youth assigned to ESD reported greater knowledge and positive attitudes and reduced social distance (Cohen's d = 0.35 and 0.16, respectively) than youth in the comparator interventions and no-intervention groups across the 2-year follow-up. Youth with high levels of mental health symptoms were more likely (odds ratio = 3.51; confidence interval = 1.08-11.31) to seek treatment during follow-up if assigned to ESD than if they were assigned to comparator interventions or no intervention.
CONCLUSIONS


ESD shows potential for improving the social climate related to mental illnesses in schools and increasing treatment seeking when needed. ESD and interventions like it show promise as part of a public mental health response to youth with mental health needs in schools.",2020,"Youth with high levels of mental health symptoms were more likely (odds ratio = 3.51; confidence interval = 1.08-11.31) to seek treatment during follow-up if assigned to ESD than if they were assigned to comparator interventions or no intervention.
","['416 youth who participated in the follow-up, and 312 (75%) of these participated for the full 2 years', 'sixth-grade classes from 14 schools in 2011 and 2012 with follow-up at 6-month intervals through 24 months (2012-2015', 'classrooms in an ethnically and socioeconomically diverse school district', 'Mental Illness Stigma']",['ESD to a no-intervention control and to 2 comparator interventions: (1) contact with 2 young adults with a history of mental illness and (2) exposure to antistigma printed materials'],"['mental health symptoms', 'knowledge and positive attitudes, social distance from peers with mental illness, and mental health treatment seeking', 'knowledge and positive attitudes and reduced social distance']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0034036', 'cui_str': 'Printed material'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0037412', 'cui_str': 'Social Distance'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}]",2.0,0.0591902,"Youth with high levels of mental health symptoms were more likely (odds ratio = 3.51; confidence interval = 1.08-11.31) to seek treatment during follow-up if assigned to ESD than if they were assigned to comparator interventions or no intervention.
","[{'ForeName': 'Bruce G', 'Initials': 'BG', 'LastName': 'Link', 'Affiliation': 'Department of Sociology, School of Public Policy, University of California, Riverside, Riverside, California; bruce.link@ucr.edu.'}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'DuPont-Reyes', 'Affiliation': 'Latino Research Institute, The University of Texas at Austin, Austin, Texas.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Barkin', 'Affiliation': 'Mental Health Connection of Tarrant County, Fort Worth, Texas.'}, {'ForeName': 'Alice P', 'Initials': 'AP', 'LastName': 'Villatoro', 'Affiliation': 'Latino Research Institute, The University of Texas at Austin, Austin, Texas.'}, {'ForeName': 'Jo C', 'Initials': 'JC', 'LastName': 'Phelan', 'Affiliation': 'Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, New York; and.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Painter', 'Affiliation': 'School of Social Work, University of Texas Arlington, Arlington, Texas.'}]",Pediatrics,['10.1542/peds.2019-0780']
945,17681339,Evaluation of ovarian adhesion formation after laparoscopic ovarian drilling by second-look minilaparoscopy.,"OBJECTIVE


To determine the incidence, site, and grade of ovarian adhesion formation after laparoscopic ovarian drilling (LOD) and analyze the association between the number of punctures made and the incidence and grade of adhesions, and evaluate the lateral distribution of the adhesions.
DESIGN


Prospective clinical study.
SETTING


University hospital endocrine and infertility center.
PATIENT(S)


Ninety-six anovulatory infertile women with polycystic ovarian syndrome (PCOS) treated with LOD.
INTERVENTION(S)


Women were randomized into two study groups of 48 women each, one treated with 6 punctures on the left ovary and 12 on the right, and the other treated with 6 punctures on the right ovary and 12 on the left. A short-term second-look minilaparoscopy was performed to evaluate postsurgical adhesion formation.
MAIN OUTCOME MEASURE(S)


[1] Evaluation of the incidence and grade (thin, dense, cohesive) of ovarian adhesions; [2] comparative analysis of the incidence and grade of ovarian adhesions between ovaries treated with 6 and 12 punctures; and [3] comparative analysis of the incidence and grade of ovarian adhesions between the two sides.
RESULT(S)


Adhesion formation was detected in 54 of the 90 women (60%) and in 83 of the 180 ovaries treated (46%). Dense adhesions were more likely to develop on the left ovaries to a statistically significant extent, and independently of the number of ovarian punctures performed (odds ratio [OR] = 4.34, 95% confidence interval [CI] = 1.72-10.94). Logistic regression analysis showed that the incidence of ovarian adhesions was independent of both number of punctures (OR = 1.05, 95% CI = 0.58-1.88) and side (OR = 1.37, 95% CI = 0.76-2.46).
CONCLUSION(S)


The incidence of ovarian adhesion formation after LOD was high, and their extent and severity was not influenced by the number of ovarian punctures; however, the left ovary appeared more prone to develop severe adhesions than the contralateral one.",2008,"Dense adhesions were more likely to develop on the left ovaries to a statistically significant extent, and independently of the number of ovarian punctures performed (odds ratio [OR] = 4.34, 95% confidence interval [CI] = 1.72-10.94).","['University hospital endocrine and infertility center', '\n\n\nNinety-six', 'anovulatory infertile women with polycystic ovarian syndrome (PCOS) treated with LOD']","['laparoscopic ovarian drilling by second-look minilaparoscopy', 'laparoscopic ovarian drilling (LOD']","['number of ovarian punctures', 'incidence of ovarian adhesions', 'incidence and grade of ovarian adhesions', 'Adhesion formation', 'ovarian adhesion formation']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0429468', 'cui_str': 'Anovulatory (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0473275', 'cui_str': 'Multicauterization of ovary (procedure)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1868824', 'cui_str': 'Ovarian adhesion'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}]",,0.0526363,"Dense adhesions were more likely to develop on the left ovaries to a statistically significant extent, and independently of the number of ovarian punctures performed (odds ratio [OR] = 4.34, 95% confidence interval [CI] = 1.72-10.94).","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Mercorio', 'Affiliation': 'Department of Gynaecology and Obstetrics, and Pathophysiology of Human Reproduction, University of Naples ""Federico II,"" Naples, Italy. Electronic address: fmercorio@libero.it.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Mercorio', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Foggia, Foggia, Italy.'}, {'ForeName': 'Attilio', 'Initials': 'A', 'LastName': 'Di Spiezio Sardo', 'Affiliation': 'Department of Gynaecology and Obstetrics, and Pathophysiology of Human Reproduction, University of Naples ""Federico II,"" Naples, Italy.'}, {'ForeName': 'Gian', 'Initials': 'G', 'LastName': 'Vincenzo Barba', 'Affiliation': 'Epidemiology of Population Genetics, Institute of Food Science, C.N.R. Avellino, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Pellicano', 'Affiliation': 'Department of Gynaecology and Obstetrics, and Pathophysiology of Human Reproduction, University of Naples ""Federico II,"" Naples, Italy.'}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'Nappi', 'Affiliation': 'Department of Gynaecology and Obstetrics, and Pathophysiology of Human Reproduction, University of Naples ""Federico II,"" Naples, Italy.'}]",Fertility and sterility,['10.1016/j.fertnstert.2007.05.009']
946,32069467,"Effectiveness of an Adjunctive Psychotherapeutic Intervention Developed for Enhancing the Placebo Effect of Antidepressants Used within an Inpatient-Treatment Program of Major Depression: A Pragmatic Parallel-Group, Randomized Controlled Trial.",,2020,,['Major Depression'],['Adjunctive Psychotherapeutic Intervention'],[],"[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]",[],[],,0.0681857,,"[{'ForeName': 'Benedikt Bernd', 'Initials': 'BB', 'LastName': 'Claus', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatic Medicine, Evangelisches Krankenhaus Castrop-Rauxel, Academic Teaching Hospital of the University of Duisburg-Essen, Castrop-Rauxel, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Scherbaum', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, LVR-Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Bonnet', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatic Medicine, Evangelisches Krankenhaus Castrop-Rauxel, Academic Teaching Hospital of the University of Duisburg-Essen, Castrop-Rauxel, Germany, udo.bonnet@uni-due.de.'}]",Psychotherapy and psychosomatics,['10.1159/000505855']
947,17662284,Randomized double-blind comparison of laser zona pellucida thinning and breaching in frozen-thawed embryo transfer at the cleavage stage.,"OBJECTIVE


To compare the implantation and ongoing pregnancy rates of frozen-thawed embryo transfer (FET) using laser thinning with those of laser breaching of the zona pellucida (ZP).
DESIGN


Double-blind randomized study.
SETTING


A tertiary assisted reproduction unit.
PATIENT(S)


Infertile patients undergoing FET cycles.
INTERVENTION(S)


In the thinning group, more than a quarter of the ZP's outer half-diameter was removed by using a 1,480-nm noncontact laser, whereas a hole about 30 microm in size was created in the ZP in the breaching group.
MAIN OUTCOME MEASURE(S)


Implantation and ongoing pregnancy rates.
RESULT(S)


On the day of the FET, 180 patients were randomly divided into the thinning and breaching groups according to a computer-generated randomization list that was placed in sealed envelopes. The two groups were comparable in terms of demographic characteristics, ovarian response of the stimulated cycle, and quality of fresh and frozen-thawed embryos. The implantation and ongoing pregnancy rates of the thinning group were significantly higher than the corresponding rates of the breaching group but were similar to those of patients without ZP thinning or breaching.
CONCLUSION(S)


Laser ZP thinning is associated with significantly higher implantation and ongoing pregnancy rates in FET cycles compared with the case of laser ZP breaching.",2008,Laser ZP thinning is associated with significantly higher implantation and ongoing pregnancy rates in FET cycles compared with the case of laser ZP breaching.,"['\n\n\nInfertile patients undergoing FET cycles', '180 patients']","['laser zona pellucida thinning and breaching', 'frozen-thawed embryo transfer (FET']","['implantation and ongoing pregnancy rates', 'Implantation and ongoing pregnancy rates', 'demographic characteristics, ovarian response of the stimulated cycle, and quality of fresh and frozen-thawed embryos']","[{'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0643582', 'cui_str': 'FETS'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0043519', 'cui_str': 'Zona Pellucida'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0643582', 'cui_str': 'FETS'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0677542', 'cui_str': 'Frozen (qualifier value)'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}]",180.0,0.163451,Laser ZP thinning is associated with significantly higher implantation and ongoing pregnancy rates in FET cycles compared with the case of laser ZP breaching.,"[{'ForeName': 'Ernest Hung Yu', 'Initials': 'EHY', 'LastName': 'Ng', 'Affiliation': ""Department of Obstetrics and Gynaecology, The University of Hong Kong, Hong Kong Special Administrative Region, People's Republic of China. Electronic address: nghye@hkucc.hku.hk.""}, {'ForeName': 'Estella Yee Lan', 'Initials': 'EYL', 'LastName': 'Lau', 'Affiliation': ""Department of Obstetrics and Gynaecology, The University of Hong Kong, Hong Kong Special Administrative Region, People's Republic of China.""}, {'ForeName': 'William Shu Biu', 'Initials': 'WSB', 'LastName': 'Yeung', 'Affiliation': ""Department of Obstetrics and Gynaecology, The University of Hong Kong, Hong Kong Special Administrative Region, People's Republic of China.""}, {'ForeName': 'Tak Ming', 'Initials': 'TM', 'LastName': 'Cheung', 'Affiliation': ""Department of Obstetrics and Gynaecology, The University of Hong Kong, Hong Kong Special Administrative Region, People's Republic of China.""}, {'ForeName': 'Oi Shan', 'Initials': 'OS', 'LastName': 'Tang', 'Affiliation': ""Department of Obstetrics and Gynaecology, The University of Hong Kong, Hong Kong Special Administrative Region, People's Republic of China.""}, {'ForeName': 'Pak Chung', 'Initials': 'PC', 'LastName': 'Ho', 'Affiliation': ""Department of Obstetrics and Gynaecology, The University of Hong Kong, Hong Kong Special Administrative Region, People's Republic of China.""}]",Fertility and sterility,['10.1016/j.fertnstert.2007.05.016']
948,17603048,"Effect of sibutramine on weight reduction in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial.","OBJECTIVE


To examine the efficacy of sibutramine together with brief lifestyle modification for weight reduction in obese women with polycystic ovary syndrome (PCOS).
DESIGN


Investigator-initiated, multicenter, double-blind, randomized, parallel-group clinical trial.
SETTING


Departments of Obstetrics and Gynecology in primary care, referral centers, and private practice.
PATIENT(S)


Forty-two patients with confirmed PCOS were included in the study, and 34 patients completed the study.
INTERVENTION


Sibutramine 15 mg once daily together with brief lifestyle modification was compare with placebo together with brief lifestyle modification.
MAIN OUTCOME MEASURE(S)


The primary endpoint was to assess weight loss. Secondary endpoints included the efficacy of sibutramine for treatment of menstrual pattern and cardiovascular risk factors.
RESULT(S)


After 6 months the sibutramine group had lost 7.8 +/- 5.1 kg compared with a weight loss of 2.8 +/- 6.2 kg in the placebo group. Sibutramine treatment resulted in significant decreases in apolipoprotein B, apolipoprotein B/apolipoprotein A ratio, triglycerides, and cystatin C levels.
CONCLUSION(S)


Sibutramine in combination with lifestyle intervention results in significant weight reduction in obese patients with PCOS. In addition to the weight loss, sibutramine seems to have beneficial effects on metabolic and cardiovascular risk factors.",2008,"Sibutramine treatment resulted in significant decreases in apolipoprotein B, apolipoprotein B/apolipoprotein A ratio, triglycerides, and cystatin C levels.
","['Forty-two patients with confirmed PCOS were included in the study, and 34 patients completed the study', 'obese patients with PCOS', 'obese women with polycystic ovary syndrome (PCOS', 'women with polycystic ovary syndrome', 'Departments of Obstetrics and Gynecology in primary care, referral centers, and private practice']","['Sibutramine', 'lifestyle intervention', 'placebo', 'sibutramine']","['apolipoprotein B, apolipoprotein B/apolipoprotein A ratio, triglycerides, and cystatin C levels', 'weight reduction', 'menstrual pattern and cardiovascular risk factors', 'weight loss']","[{'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}]","[{'cui': 'C0074493', 'cui_str': 'sibutramine'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0003592', 'cui_str': 'Apo-A'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",42.0,0.592698,"Sibutramine treatment resulted in significant decreases in apolipoprotein B, apolipoprotein B/apolipoprotein A ratio, triglycerides, and cystatin C levels.
","[{'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Lindholm', 'Affiliation': 'Department of Obstetrics and Gynecology, Sunderby Hospital, Luleå, Sweden. Electronic address: asa.lindholm@nll.se.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Bixo', 'Affiliation': 'Department of Clinical Science, Obstetrics and Gynecology, University Hospital, Umeå, Sweden.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Björn', 'Affiliation': 'Department of Clinical Science, Obstetrics and Gynecology, University Hospital, Umeå, Sweden; Läkarhuset Björnen, Piteå, Sweden.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Wölner-Hanssen', 'Affiliation': 'Department of Obstetrics and Gynecology, Lund University Hospital, Lund, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Eliasson', 'Affiliation': 'Department of Internal Medicine, Sunderby Hospital, Luleå, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Larsson', 'Affiliation': 'Department of Clinical Chemistry, University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Owe', 'Initials': 'O', 'LastName': 'Johnson', 'Affiliation': 'Department of Internal Medicine, University Hospital, Umeå, Sweden.'}, {'ForeName': 'Inger Sundström', 'Initials': 'IS', 'LastName': 'Poromaa', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}]",Fertility and sterility,['10.1016/j.fertnstert.2007.05.002']
949,32428718,Prospective Randomized Study on the Effects of Improved Sleep Quality After Craniotomy on Melatonin Concentrations and Inflammatory Response in Neurosurgical Intensive Care Patients.,"OBJECTIVE


Sleep disorders in intensive care units after a craniotomy can decrease melatonin secretion and increase the inflammatory stress response. The aim of this study was to investigate the influence of improving sleep quality via eye patches and earplugs on melatonin secretion and inflammatory mediator release.
METHODS


The study enrolled 41 patients who underwent craniotomy. Patients were randomized into 2 groups. ""Group Intervention"" received a sleep-promoting intervention with eye patches and earplugs to provide light and noise isolation, while ""Group Control"" received standard care. Blood levels of C-reactive protein and interleukin 1 and interleukin 6 along with urine levels of 6-sulphatoxymelatonin (aMT6) were measured preoperatively (baseline) and on postoperative days 1 and 3. Sleep quality was assessed with the Richards-Campbell Sleep Questionnaire.
RESULTS


Sleep quality was higher in the intervention group (Richards-Campbell score:80.61 ± 11.96 vs. 33.50 ± 16.32; P < 0.001). Urine aMT6 levels increased significantly in the intervention group in spot urine samples from 10.15 (5.38-14.40) ng/mL at baseline to 14.52 (6.24-29.11) and 11.51 (7.88-29.05) ng/mL on postoperative days 1 and 3. They also increased in 24-hour urine samples from 25.73 (8.24-52.73) ng/mL at baseline to 35.38 (11.48-95.65) and 39.18 (2.36-125.23) ng/mL on postoperative days 1 and 3 (P = 0.001 and P = 0.005, respectively). The aMT6 concentration did not change significantly in the control group. The C-reactive protein concentrations increased postoperatively compared with baseline concentrations in both groups (P = 0.001 and P < 0.001).
CONCLUSIONS


Melatonin secretion significantly increased as a result of improving postoperative sleep quality by noise and light isolation in neurosurgical intensive care unit patients after craniotomy.",2020,"The CRP concentrations increased postoperatively compared to baseline concentrations in both groups (p=0.001 and p<0.001).
","['neurosurgical ICU patients after craniotomy', 'neurosurgical intensive-care patients 2 ', '41 patients who underwent craniotomy']","['sleep-promoting intervention with eye patches and earplugs to provide light and noise isolation, while Group Control received standard care']","['levels', 'Blood levels of C reactive protein (CRP) and interleukin 1(IL-1) and 6 (IL-6) along with urine levels of 6-sulphatoxymelatonin (aMT6', '24-hour urine samples', 'aMT6 concentration', 'Urine aMT6', 'Sleep quality', 'postoperative sleep quality', 'CRP concentrations', 'melatonin secretion', 'sleep quality', 'inflammatory stress response']","[{'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0776981', 'cui_str': 'Eye patch'}, {'cui': 'C1135964', 'cui_str': 'Ear plug'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0049713', 'cui_str': '6-sulfatoxymelatonin'}, {'cui': 'C0456209', 'cui_str': '24 hour urine sample'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",41.0,0.140342,"The CRP concentrations increased postoperatively compared to baseline concentrations in both groups (p=0.001 and p<0.001).
","[{'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Arık', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey. Electronic address: emineincearik@yahoo.com.'}, {'ForeName': 'Habibullah', 'Initials': 'H', 'LastName': 'Dolgun', 'Affiliation': 'Department of Neurosurgery, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Sahin', 'Initials': 'S', 'LastName': 'Hanalioglu', 'Affiliation': 'Department of Neurosurgery, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Omer Selcuk', 'Initials': 'OS', 'LastName': 'Sahin', 'Affiliation': 'Department of Neurosurgery, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Ucar', 'Affiliation': 'Department of Clinical Biochemistry, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Yazicioglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Ihsan', 'Initials': 'I', 'LastName': 'Dogan', 'Affiliation': 'Department of Neurosurgery, Ankara University, İbn-i Sina Hospital, Ankara, Turkey.'}, {'ForeName': 'Erdal Resit', 'Initials': 'ER', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Neurosurgery, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}]",World neurosurgery,['10.1016/j.wneu.2020.05.017']
950,17686479,Anastrozole or letrozole for ovulation induction in clomiphene-resistant women with polycystic ovarian syndrome: a prospective randomized trial.,"OBJECTIVE


To compare the effects of letrozole (2.5 mg) and anastrozole (1 mg) meant for ovulation induction in clomiphene (CC)-resistant women with PCOS.
DESIGN


Prospective randomized trial.
SETTING


University teaching hospital and private practice setting.
PATIENT(S)


The study comprised a total of 220 infertile women (574 cycles) with CC-resistant PCOS.
INTERVENTION(S)


Patients were randomized to treatment with 2.5 mg of letrozole daily (111 patients, 295 cycles) or 1 mg of anastrozole daily (109 patients, 279 cycles) for 5 days from day 3 of menses.
MAIN OUTCOME MEASURE(S)


Number of follicles, serum E(2), serum P, endometrial thickness, pregnancy rate (PR), and miscarriage rate.
RESULT(S)


The total number of follicles was significantly more in the anastrozole group (5.4 +/- 0.4 vs. 5.8 +/- 0.4). The number of follicles > or = 14 mm (3.1 +/- 0.3 vs. 2.7 +/- 0.2) and > or = 18 mm (2.3 +/- 0.1 vs. 3.1 +/- 0.2) were significantly higher in the anastrozole group. The endometrial thickness at the time of hCG administration was significantly more in the anastrozole group (9.1 +/- 0.2 vs. 10.2 +/- 0.7 mm). The duration to reach a dominant follicle was longer in the letrozole group (12.1 +/- 1.3 days vs. 8.8 +/- 1.9 days) but without statistical significant difference. Ovulation occurred in 183/295 cycles (62%) in the letrozole group and 177/279 cycles (63.4%) in the anastrozole group, whereas pregnancy occurred in 36/295 cycles (12.2%) in the letrozole group and 42/279 cycles (15.1%) in the anastrozole group and the differences were not statistically significant.
CONCLUSION(S)


The results of this study did not show a significant difference in PR or miscarriage rate between anastrozole and letrozole when used for ovulation induction in women with CC-resistant PCOS.",2008,The endometrial thickness at the time of hCG administration was significantly more in the anastrozole group (9.1 +/-,"['women with CC-resistant PCOS', 'University teaching hospital and private practice setting', 'clomiphene (CC)-resistant women with PCOS', '220 infertile women (574 cycles) with CC-resistant PCOS', 'clomiphene-resistant women with polycystic ovarian syndrome']","['Anastrozole or letrozole', 'anastrozole', 'letrozole', 'anastrozole and letrozole']","['Number of follicles, serum E(2), serum P, endometrial thickness, pregnancy rate (PR), and miscarriage rate', 'endometrial thickness', 'Ovulation', 'total number of follicles', 'pregnancy', 'duration to reach a dominant follicle', 'PR or miscarriage rate']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0009008', 'cui_str': 'Clomiphene'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}]","[{'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}]",220.0,0.0807456,The endometrial thickness at the time of hCG administration was significantly more in the anastrozole group (9.1 +/-,"[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Badawy', 'Affiliation': 'Department of Obstetrics & Gynecology, Mansoura University, Mansoura, Egypt. Electronic address: ambadawy@yahoo.com.'}, {'ForeName': 'Abeer', 'Initials': 'A', 'LastName': 'Mosbah', 'Affiliation': 'Department of Clinical Pathology, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Shady', 'Affiliation': 'Department of Radiology, Mansoura University, Mansoura, Egypt.'}]",Fertility and sterility,['10.1016/j.fertnstert.2007.05.010']
951,17582406,Clomiphene citrate or letrozole for ovulation induction in women with polycystic ovarian syndrome: a prospective randomized trial.,"OBJECTIVE


To compare the effects of letrozole (5 mg) and clomiphene citrate (100 mg) for ovulation induction in women with polycystic ovary syndrome (PCOS).
DESIGN


Prospective randomized trial.
SETTING


University teaching hospital and private practice setting.
PATIENT(S)


The study comprised a total of 438 infertile women (1063 cycles) with PCOS.
INTERVENTION(S)


Patients were randomized to treatment with 5 mg of letrozole daily (218 patients, 545 cycles) or 100 mg of clomiphene citrate daily (220 patients, 518 cycles) for 5 days starting on day 3 of menses. Timed intercourse was advised 24 to 36 hours after hCG injection.
MAIN OUTCOME MEASURE(S)


Number of follicles, serum estradiol, serum progesterone, endometrial thickness, and pregnancy and miscarriage rates.
RESULT(S)


The mean age, parity, and duration of infertility in both groups were similar. The total number of follicles was statistically significantly greater in the clomiphene citrate group (6.8 +/- 0.3 versus 4.4 +/- 0.4). Endometrial thickness at the time of hCG administration was statistically significantly greater in the CC group (9.2 +/- 0.7 mm versus 8.1 +/- 0.2 mm). The duration to reach a dominant follicle was statistically significantly longer in the letrozole group (12.1 +/- 1.3 versus 8.8 +/- 2.9 days). Ovulation occurred in 365 out of 540 cycles (67.5%) in letrozole group and 371 out of 523 cycles (70.9%) without a statistically significant difference. Levels of serum estradiol and progesterone were statistically significantly higher in the clomiphene citrate group. The pregnancy rate per cycle was 15.1% in the letrozole group and 17.9% in the clomiphene citrate group without statistically difference between the groups.
CONCLUSION(S)


The results of this study did not show any advantage to the use of letrozole over clomiphene citrate as a first-line treatment for induction of ovulation in women with PCOS.",2009,Levels of serum estradiol and progesterone were statistically significantly higher in the clomiphene citrate group.,"['women with polycystic ovary syndrome (PCOS', 'University teaching hospital and private practice setting', '438 infertile women (1063 cycles) with PCOS', 'women with PCOS', 'women with polycystic ovarian syndrome']","['clomiphene citrate daily', 'Clomiphene citrate or letrozole', 'letrozole', 'clomiphene citrate']","['Number of follicles, serum estradiol, serum progesterone, endometrial thickness, and pregnancy and miscarriage rates', 'mean age, parity, and duration of infertility', 'Ovulation', 'Timed intercourse', 'pregnancy rate per cycle', 'total number of follicles', 'Levels of serum estradiol and progesterone', 'duration to reach a dominant follicle', 'Endometrial thickness']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}]","[{'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}]",438.0,0.0622772,Levels of serum estradiol and progesterone were statistically significantly higher in the clomiphene citrate group.,"[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Badawy', 'Affiliation': 'Department of Obstetrics and Gynecology, Mansoura University, Mansoura, Egypt. Electronic address: ambadawy@yahoo.com.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Abdel Aal', 'Affiliation': 'Department of Clinical Pathology, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abulatta', 'Affiliation': 'Department of Radiology, Mansoura University, Mansoura, Egypt.'}]",Fertility and sterility,['10.1016/j.fertnstert.2007.02.062']
952,30871934,Bone turnover markers in women participating in a dose-finding trial of a contraceptive vaginal ring releasing Nestorone and estradiol.,"OBJECTIVE


To evaluate changes in the bone turnover markers CTx and P1NP during 6 months' use of novel continuous contraceptive vaginal rings delivering Nestorone (NES) 200 mcg/day and three doses of estradiol (E2) (10, 20, and 40 mcg/day).
STUDY DESIGN


This randomized trial enrolled 189 women who used two consecutive vaginal rings over 180 days. Frequent blood sampling permitted analysis of NES, E2, CTx and P1NP concentrations. The bone-turnover marker analyses included only women with complete sampling and excluded women with characteristics that might interfere with accurate measurement of bone markers such as afternoon sampling, poor ring compliance or recent pregnancy. We evaluated the change from baseline to 6 months in CTx and P1NP, stratified by ring dose and by average circulating E2 concentrations.
RESULTS


One hundred fifty-one women completed the study, and 82 women had complete data available for the bone marker analyses; the three dosage groups were balanced with regard to baseline characteristics. E2 concentrations remained low throughout treatment, regardless of which dose ring the participant used. Individual CTx changes from baseline averaged 27±56% (p<.01). Similarly, individual P1NP changes averaged 11±33% (p=.04). These increases were within the premenopausal reference ranges, and unrelated to treatment dose or to circulating E2 concentrations.
CONCLUSIONS


The low E2 dose of these rings was associated with low E2 concentrations and modest increases in serum bone turnover makers. Because we have only 6-month bone turnover markers and no direct evidence of bone loss or bone density change, these results must be interpreted with caution.
IMPLICATIONS


Nestorone, a 19-norprogesterone derivative, leads to complete ovarian suppression, which should yield excellent contraceptive effectiveness. To prevent potential adverse effects on bone, the NES contraceptive ring should be combined with higher doses of E2 than were assessed in this study.",2019,"These increases were within the premenopausal reference ranges, and unrelated to treatment dose or to circulating E2 concentrations.
","['women participating in a dose-finding trial of a', 'One hundred fifty-one women completed the study, and 82 women had complete data available for the bone marker analyses; the three dosage groups were balanced with regard to baseline characteristics', '189 women who used two consecutive vaginal rings over 180 days']","['estradiol (E2', 'contraceptive vaginal ring releasing Nestorone and estradiol', 'Nestorone (NES']","['Bone turnover markers', 'E2 concentrations', 'Individual CTx changes', 'serum bone turnover makers', 'NES, E2, CTx and P1NP concentrations']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0181734', 'cui_str': 'Bone marker'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0283986', 'cui_str': 'Nestorone'}]","[{'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0554244', 'cui_str': 'Maker (occupation)'}]",189.0,0.0707135,"These increases were within the premenopausal reference ranges, and unrelated to treatment dose or to circulating E2 concentrations.
","[{'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Tiedeken', 'Affiliation': 'Department of Obstetrics and Gynecology, and Department of Epidemiology, Columbia University Irving Medical Center, New York, NY.'}, {'ForeName': 'Carolyn L', 'Initials': 'CL', 'LastName': 'Westhoff', 'Affiliation': 'Department of Obstetrics and Gynecology, and Department of Epidemiology, Columbia University Irving Medical Center, New York, NY. Electronic address: clw3@columbia.edu.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': 'Department of Medicine, Columbia University Irving Medical Center, New York, NY.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Cremers', 'Affiliation': 'Department of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, NY.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Sitruk-Ware', 'Affiliation': 'Population Council, Center for Biomedical Research, NY, New York.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Blithe', 'Affiliation': 'Contraceptive Development Program, NICHD, NIH, Bethesda, MD.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contraception,['10.1016/j.contraception.2019.02.012']
953,32434666,Transcutaneous electrical nerve stimulation and heat to reduce pain in a chronic low back pain population: a randomized controlled clinical trial.,"BACKGROUND


Low back pain is the leading cause of disability worldwide. The therapeutic management of patients with chronic LBP is challenging.
OBJECTIVES


The aim of this study is to evaluate the effects of heat and transcutaneous electrical nerve stimulation combined on pain relief in participants with chronic low back pain.
METHODS


Fifty participants with chronic (≥3 months) low back pain were randomly assigned to two groups: HeatTens (n=25) and control group (n=25). Primary outcome was pain. Secondary outcomes were pressure pain thresholds, temporal summation, conditioned pain modulation, fear-avoidance and beliefs questionnaire, central sensitization inventory, quality of life, and medication use. The control group received no treatment and continued usual care. After four weeks of treatment, all measurements were repeated.
RESULTS


Fifty individuals participated in this study. Significant higher pressure pain threshold measures after both 30min and 4 weeks for the lower back region and the second plantar toe were found only in the experimental group.
CONCLUSION


The combination of heat and transcutaneous electrical nerve stimulation does not reduce pain scores in patients with chronic low back pain. Pressure pain threshold values significantly improved, showing beneficial effects of the experimental treatment. ClinicalTrials.gov: NCT03643731 (https://clinicaltrials.gov/ct2/show/NCT03643731).",2020,"Significant higher pressure pain threshold measures after both 30min and 4 weeks for the lower back region and the second plantar toe were found only in the experimental group.
","['patients with chronic low back pain', 'participants with chronic low back pain', 'Fifty participants with chronic (≥3 months) low back pain', 'chronic low back pain population', 'patients with chronic LBP', 'Fifty individuals participated in this study']","['heat and transcutaneous electrical nerve stimulation combined', 'Transcutaneous electrical nerve stimulation and heat to reduce pain', 'no treatment and continued usual care', 'heat and transcutaneous electrical nerve stimulation']","['pain scores', 'pain relief', 'Pressure pain threshold values', 'pressure pain thresholds, temporal summation, conditioned pain modulation, fear-avoidance and beliefs questionnaire, central sensitization inventory, quality of life, and medication use', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2938905', 'cui_str': 'Central Sensitization'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",50.0,0.110104,"Significant higher pressure pain threshold measures after both 30min and 4 weeks for the lower back region and the second plantar toe were found only in the experimental group.
","[{'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Leemans', 'Affiliation': 'Rehabilitation Research Department, Vrije Universiteit Brussel, Brussels, Belgium; Pain in Motion International Research Group, Belgium. Electronic address: Lynn.Leemans@vub.be.'}, {'ForeName': 'Ömer', 'Initials': 'Ö', 'LastName': 'Elma', 'Affiliation': 'Pain in Motion International Research Group, Belgium.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Nijs', 'Affiliation': 'Pain in Motion International Research Group, Belgium; Department of Physical Medicine and Physiotherapy, University Hospital Brussels, Belgium.'}, {'ForeName': 'Timothy H', 'Initials': 'TH', 'LastName': 'Wideman', 'Affiliation': 'School of Physical and Occupational Therapy, McGill University, Canada.'}, {'ForeName': 'Carolie', 'Initials': 'C', 'LastName': 'Siffain', 'Affiliation': 'Rehabilitation Research Department, Vrije Universiteit Brussel, Brussels, Belgium; Pain in Motion International Research Group, Belgium.'}, {'ForeName': 'Hester', 'Initials': 'H', 'LastName': 'den Bandt', 'Affiliation': 'Pain in Motion International Research Group, Belgium; Department of Physiotherapy, University of Applied Sciences Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Van Laere', 'Affiliation': 'Interfaculty Center Data Processing and Statistics, Vrije Universiteit Brussel, Belgium.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Beckwée', 'Affiliation': 'Rehabilitation Research Department, Vrije Universiteit Brussel, Brussels, Belgium; Frailty in Ageing Research Department, Vrije Universiteit Brussel, Brussels, Belgium; Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp, Belgium.'}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2020.04.001']
954,17658525,Effect of 17alpha-hydroxyprogesterone caproate before embryo transfer on the outcome of in vitro fertilization and embryo transfer: a randomized trial.,"OBJECTIVE


To assess the effect of 17alpha-hydroxyprogesterone caproate (17-HPC) given before embryo transfer on the pregnancy outcome of IVF-embryo transfer (ET) cycles.
DESIGN


Randomized controlled study.
SETTING


A university-based hospital IVF unit.
PATIENT(S)


One hundred twenty-five consecutive patients undergoing IVF-ET were randomly assigned into treatment and control groups.
INTERVENTION(S)


In the treatment group, 63 patients received 17-HPC (250 mg, i.m.), 1 day before ET. The control group consisted of 62 patients who did not receive any injections.
MAIN OUTCOME MEASURE(S)


Pregnancy and multiple-pregnancy rates.
RESULT(S)


The two groups were similar with respect to the age of patients, total dose of FSH, number of oocytes and embryos obtained, and number and quality of embryos transferred. There was no significant difference in the pregnancy rate (34.9% vs. 38.7%) or in the rate of multiple gestation (15.9% vs. 9.7%) between cases and controls, respectively.
CONCLUSION(S)


The use of 17-HPC before ET does not appear to affect the outcome of IVF-ET.",2008,"The two groups were similar with respect to the age of patients, total dose of FSH, number of oocytes and embryos obtained, and number and quality of embryos transferred.","['A university-based hospital IVF unit', 'One hundred twenty-five consecutive patients undergoing IVF-ET']","['17alpha-hydroxyprogesterone caproate', '62 patients who did not receive any injections', '17-HPC', '17alpha-hydroxyprogesterone caproate (17-HPC']","['Pregnancy and multiple-pregnancy rates', 'rate of multiple gestation', 'vitro fertilization and embryo transfer', 'total dose of FSH, number of oocytes and embryos obtained, and number and quality of embryos transferred', 'pregnancy rate']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0044971', 'cui_str': 'hydroxyprogesterone caproate (USP)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0768635', 'cui_str': 'HPC(III)'}]","[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0032989', 'cui_str': 'Multiple Pregnancy'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes (qualifier value)'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}]",125.0,0.0538897,"The two groups were similar with respect to the age of patients, total dose of FSH, number of oocytes and embryos obtained, and number and quality of embryos transferred.","[{'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Abu-Musa', 'Affiliation': 'Department of Obstetrics and Gynecology, American University of Beirut Medical Center, Beirut, Lebanon. Electronic address: aa06@aub.edu.lb.'}, {'ForeName': 'Ihab', 'Initials': 'I', 'LastName': 'Usta', 'Affiliation': 'Department of Obstetrics and Gynecology, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Anwar', 'Initials': 'A', 'LastName': 'Nassar', 'Affiliation': 'Department of Obstetrics and Gynecology, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Fatiha', 'Initials': 'F', 'LastName': 'Hajami', 'Affiliation': 'Department of Obstetrics and Gynecology, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Hannoun', 'Affiliation': 'Department of Obstetrics and Gynecology, American University of Beirut Medical Center, Beirut, Lebanon.'}]",Fertility and sterility,['10.1016/j.fertnstert.2007.05.043']
955,32428523,A randomized clinical trial to arrest dentin caries in young children using silver diamine fluoride.,"OBJECTIVES


The study aimed to compare the effectiveness of 38% silver diamine fluoride (SDF) solution, and 5% sodium fluoride (NaF) varnish applied semiannually in arresting dentin caries in young children with high caries risk.
METHODS


Children aged 1-3 years who had at least one active dentin carious lesion were randomly allocated into 2 groups as follows: Group 1 = 38% SDF (Topamine), and Group 2 = 5% NaF varnish (Duraphat). Both agents were applied every 6 months onto the carious surface. Lesion activity was assessed by the visual-tactile examination. Baseline and follow-up examinations were conducted by the same examiner. The children's demographic background, oral health-related habits, and oral hygiene practices, as well as parental satisfaction with children's dental appearance were collected at baseline and the 12-month follow-up.
RESULTS


At baseline, 153 and 149 children were recruited in Group 1 and Group 2, respectively. The mean dmfs scores in Groups 1 and 2 were 8.89 and 9.79, respectively. After 12 months, 87.1% remained in the study. The caries arrest rate of Group 1 (35.7%) was significantly higher than that of Group 2 (20.9%) (p < 0.001). The results of the multilevel logistic regression analysis confirmed that the treatment in Group 1 was more effective in arresting dentin carious lesions than that of Group 2 (OR = 2.04; 95% CI, 1.41-2.96). The presence of plaque on caries lesions, tooth type, tooth surface type, frequency of milk feeding, snack taking, and family income influenced on caries activity. Regardless of the intervention groups, there were no differences in parental satisfaction with on the child's dental appearance before and after receiving the intervention.
CONCLUSION


Based on the 12-month results, 38% SDF is more effective than 5% NaF varnish in arresting dentin carious lesions in young children. SDF has no negative impact on parental satisfaction with the child's dental appearance.
CLINICAL SIGNIFICANCE


To control dentin carious lesions in young children with high caries risk, 38% SDF is more effective than 5% NaF varnish.",2020,The caries arrest rate of Group 1 (35.7%) was significantly higher than that of Group 2 (20.9%) (p <  0.001).,"['young children using', 'young children', 'Children aged 1-3 years who had at least one active dentin carious lesion', 'young children with high caries risk']","['SDF', '38% silver diamine fluoride (SDF) solution, and 5% sodium fluoride (NaF) varnish', 'silver diamine fluoride', 'NaF varnish', 'SDF (Topamine), and Group 2\u2009=\u20095% NaF varnish (Duraphat']","['dentin carious lesions', 'mean dmfs scores', 'Lesion activity', 'caries arrest rate', 'dentin caries', 'effective in arresting dentin carious lesions', 'parental satisfaction', 'presence of plaque on caries lesions, tooth type, tooth surface type, frequency of milk feeding, snack taking, and family income influenced on caries activity']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0058817', 'cui_str': 'Duraphat'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0266848', 'cui_str': 'Arrested dental caries'}, {'cui': 'C0266846', 'cui_str': 'Dental caries extending into dentin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0447301', 'cui_str': 'Tooth surface'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0021162', 'cui_str': 'Income'}]",,0.0269155,The caries arrest rate of Group 1 (35.7%) was significantly higher than that of Group 2 (20.9%) (p <  0.001).,"[{'ForeName': 'Sirinan', 'Initials': 'S', 'LastName': 'Mabangkhru', 'Affiliation': 'Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Duangporn', 'Initials': 'D', 'LastName': 'Duangthip', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Chun Hung', 'Initials': 'CH', 'LastName': 'Chu', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Araya', 'Initials': 'A', 'LastName': 'Phonghanyudh', 'Affiliation': 'Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Varangkanar', 'Initials': 'V', 'LastName': 'Jirarattanasopha', 'Affiliation': 'Faculty of Dentistry, Mahidol University, Bangkok, Thailand. Electronic address: Varangkanar.jir@mahidol.ac.th.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103375']
956,32434932,Vaginal probiotic adherence and acceptability in Rwandan women with high sexual risk participating in a pilot randomised controlled trial: a mixed-methods approach.,"OBJECTIVES


To evaluate adherence and acceptability of intermittent vaginal probiotic or antibiotic use to prevent bacterial vaginosis (BV) recurrence.
DESIGN


Repeated adherence and acceptability assessments using mixed methods within a pilot randomised controlled trial.
SETTING


Research clinic in Kigali, Rwanda.
PARTICIPANTS


Rwandan women with high sexual risk.
INTERVENTIONS


Women diagnosed with BV and/or trichomoniasis were randomised to four groups (n=17 each) after completing metronidazole treatment: behavioural counselling only, or behavioural counselling plus 2-month intermittent use of oral metronidazole, Ecologic Femi+ (EF+) vaginal capsule or Gynophilus LP (GynLP) vaginal tablet.
OUTCOME MEASURES


Adherence and acceptability were assessed by structured face-to-face interviews, semi-structured focus group discussions and in-depth interviews, daily diaries and counting of used/unused study products in randomised women (n=68). Vaginal infection knowledge was assessed by structured face-to-face interviews in randomised women and women attending recruitment sessions (n=131).
RESULTS


Most women (93%) were sex workers, 99.2% were unfamiliar with BV and none had ever used probiotics. All probiotic users (n=32) reported that insertion became easier over time. Triangulated adherence data showed that 17/17 EF+ users and 13/16 GynLP users used ≥80% of required doses (Fisher's exact p=0.103). Younger age (p=0.076), asking many questions at enrolment (p=0.116), having menses (p=0.104) and reporting urogenital symptoms (p=0.103) were non-significantly associated with lower perfect adherence. Women believed that the probiotics reduced BV recurrence, but reported that partners were sometimes unsupportive of study participation. Self-reported vaginal washing practices decreased during follow-up, but sexual risk behaviours did not. Most women (12/15) with an uncircumcised steady partner discussed penile hygiene with him, but many women found this difficult, especially with male clients.
CONCLUSIONS


High-risk women require education about vaginal infections. Vaginal probiotic acceptability and adherence were high in this cohort. Our results can be used to inform future product development and to fine-tune counselling messages in prevention programmes.
TRIAL REGISTRATION NUMBER


NCT02459665.",2020,"Younger age (p=0.076), asking many questions at enrolment (p=0.116), having menses (p=0.104) and reporting urogenital symptoms (p=0.103) were non-significantly associated with lower perfect adherence.","['Research clinic in Kigali, Rwanda', 'randomised women and women attending recruitment sessions (n=131', 'Rwandan women with high sexual risk participating', 'Rwandan women with high sexual risk', 'Women diagnosed with BV and/or trichomoniasis', 'Most women (93%) were sex workers, 99.2% were unfamiliar with BV and none had ever used probiotics']","['EF+) vaginal capsule or Gynophilus LP (GynLP) vaginal tablet', 'intermittent vaginal probiotic or antibiotic', 'metronidazole treatment: behavioural counselling only, or behavioural counselling plus 2-month intermittent use of oral metronidazole, Ecologic Femi']","['Self-reported vaginal washing practices', 'Vaginal probiotic adherence and acceptability', 'Vaginal infection knowledge', 'sexual risk behaviours', 'Adherence and acceptability', 'BV recurrence', 'Vaginal probiotic acceptability and adherence', 'reporting urogenital symptoms']","[{'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0040921', 'cui_str': 'Infection by Trichomonas'}, {'cui': 'C0240816', 'cui_str': 'Sex worker'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}]","[{'cui': 'C1273011', 'cui_str': 'Vaginal capsule'}, {'cui': 'C0042264', 'cui_str': 'Vaginal tablet'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0360345', 'cui_str': 'Metronidazole-containing product in oral dose form'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0404521', 'cui_str': 'Infective vaginitis'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.22675,"Younger age (p=0.076), asking many questions at enrolment (p=0.116), having menses (p=0.104) and reporting urogenital symptoms (p=0.103) were non-significantly associated with lower perfect adherence.","[{'ForeName': 'Marijn C', 'Initials': 'MC', 'LastName': 'Verwijs', 'Affiliation': 'Department of Clinical Infection, Microbiology and Immunology, Institute of Infection and Global Health, University of Liverpool, Liverpool, Merseyside, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Agaba', 'Affiliation': 'Rinda Ubuzima, Kigali, Rwanda.'}, {'ForeName': 'Marie Michele', 'Initials': 'MM', 'LastName': 'Umulisa', 'Affiliation': 'Rinda Ubuzima, Kigali, Rwanda.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Uwineza', 'Affiliation': 'Rinda Ubuzima, Kigali, Rwanda.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Nivoliez', 'Affiliation': 'Biose, Aurillac, France.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Lievens', 'Affiliation': 'Winclove, Amsterdam, The Netherlands.'}, {'ForeName': 'Janneke H H M', 'Initials': 'JHHM', 'LastName': 'van de Wijgert', 'Affiliation': 'Department of Clinical Infection, Microbiology and Immunology, Institute of Infection and Global Health, University of Liverpool, Liverpool, Merseyside, UK j.vandewijgert@liverpool.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-031819']
957,31494273,Effects of Oxytocin on Placebo and Nocebo Effects in a Pain Conditioning Paradigm: A Randomized Controlled Trial.,"Oxytocin has been shown to increase trust, decrease anxiety, and affect learning as has been observed in conditioning paradigms. Trust, anxiety, and learning are important factors that influence placebo effects. In this study, we investigated whether oxytocin can increase placebo analgesia, decrease nocebo hyperalgesia, and influence extinction processes of both. Eighty male volunteers were assigned to a 40 IU of oxytocin nasal spray group, or to a placebo control group. Placebo analgesia and nocebo hyperalgesia were induced by a conditioning procedure in combination with verbal suggestions. The results demonstrate that the conditioning procedure successfully elicited significant placebo analgesia and nocebo hyperalgesia responses (P < .001). Furthermore, extinction was observed (P < .001), although placebo and nocebo responses did not return to baseline and remained significant. Oxytocin did not influence placebo analgesia or nocebo hyperalgesia and had no effect on extinction. This study provides support against the placebo-boosting effects of oxytocin and was the first one to demonstrate that it also did not influence nocebo effects or extinction processes, however, these results pertain to only a male sample. As managing placebo and nocebo effects has widespread clinical implications, further research should investigate other neurobiological or behavioral pathways to boost placebo and decrease nocebo effects. PERSPECTIVE: The present study demonstrated that placebo analgesia and nocebo hyperalgesia can be successfully induced by conditioning and verbal suggestions. We could not confirm the hypothesis that oxytocin affects either of these phenomena. Other pharmacological agents and behavioral manipulations for increasing placebo and decreasing nocebo effects should be investigated.",2020,"Furthermore, extinction was observed (p < .001), although placebo and nocebo responses did not return to baseline and remained significant.","['Eighty male volunteers', 'a pain conditioning paradigm']","['Placebo', 'oxytocin nasal spray', 'oxytocin', 'placebo', 'Oxytocin', 'placebo control group']","['placebo analgesia and nocebo hyperalgesia responses', 'nocebo hyperalgesia', 'extinction']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesic Sensations'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}]",80.0,0.345239,"Furthermore, extinction was observed (p < .001), although placebo and nocebo responses did not return to baseline and remained significant.","[{'ForeName': 'Aleksandrina', 'Initials': 'A', 'LastName': 'Skvortsova', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Institute of Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Leiden, The Netherlands; Leiden Institute for Brain and Cognition, Leiden, The Netherlands. Electronic address: a.skvortsova@fsw.leidenuniv.nl.'}, {'ForeName': 'Dieuwke S', 'Initials': 'DS', 'LastName': 'Veldhuijzen', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Institute of Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Leiden, The Netherlands; Leiden Institute for Brain and Cognition, Leiden, The Netherlands.'}, {'ForeName': 'Henriët', 'Initials': 'H', 'LastName': 'van Middendorp', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Institute of Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Leiden, The Netherlands; Leiden Institute for Brain and Cognition, Leiden, The Netherlands.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Colloca', 'Affiliation': 'Department of Pain Translational Symptoms Science, School of Nursing and Department of Anaesthesiology, Medicine, University of Maryland Baltimore, Baltimore, Maryland.'}, {'ForeName': 'Andrea W M', 'Initials': 'AWM', 'LastName': 'Evers', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Institute of Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Leiden, The Netherlands; Leiden Institute for Brain and Cognition, Leiden, The Netherlands; Department of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.08.010']
958,31366999,The effectiveness of home versus community-based weight control programmes initiated soon after breast cancer diagnosis: a randomised controlled trial.,"BACKGROUND


Breast cancer diagnosis may be a teachable moment for lifestyle behaviour change and to prevent adjuvant therapy associated weight gain. We assessed the acceptability and effectiveness of two weight control programmes initiated soon after breast cancer diagnosis to reduce weight amongst overweight or obese women and prevent gains in normal-weight women.
METHODS


Overweight or obese (n = 243) and normal weight (n = 166) women were randomised to a three-month unsupervised home (home), a supervised community weight control programme (community) or to standard written advice (control). Primary end points were change in weight and body fat at 12 months. Secondary end points included change in insulin, cardiovascular risk markers, quality of life and cost-effectiveness of the programmes.
RESULTS


Forty-three percent of eligible women were recruited. Both programmes reduced weight and body fat: home vs. control mean (95% CI); weight -2.3 (-3.5, -1.0) kg, body fat -1.6 (-2.6, -0.7) kg, community vs. control; weight -2.4 (-3.6, -1.1) kg, body fat -1.4 (-2.4, -0.5) kg (all p < 0.001). The community group increased physical activity, reduced insulin, cardiovascular disease risk markers, increased QOL and was cost-effective.
CONCLUSIONS


The programmes were equally effective for weight control, but the community programme had additional benefits.
CLINICAL TRIAL REGISTRATION


ISRCTN68576140.",2019,Both programmes reduced weight and body fat: home vs. control,"['overweight or obese women and prevent gains in normal-weight women', 'Forty-three percent of eligible women were recruited', 'Overweight or obese (n\u2009=\u2009243) and normal weight (n\u2009', '166) women', 'breast cancer diagnosis']","['home versus community-based weight control programmes', 'supervised community weight control programme (community) or to standard written advice (control']","['change in weight and body fat', 'acceptability and effectiveness', 'change in insulin, cardiovascular risk markers, quality of life and cost-effectiveness of the programmes', 'physical activity, reduced insulin, cardiovascular disease risk markers, increased QOL and was cost-effective', 'weight and body fat']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen (regime/therapy)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0034380'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",,0.108066,Both programmes reduced weight and body fat: home vs. control,"[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Harvie', 'Affiliation': 'Prevent Breast Cancer Research Unit, The Nightingale Centre, Manchester University NHS Foundation Trust, Manchester, UK. michelle.harvie@manchester.ac.uk.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Pegington', 'Affiliation': 'Prevent Breast Cancer Research Unit, The Nightingale Centre, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'McMullan', 'Affiliation': 'Prevent Breast Cancer Research Unit, The Nightingale Centre, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Bundred', 'Affiliation': 'Manchester Breast Centre, Manchester Cancer Research Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Livingstone', 'Affiliation': 'The Nightingale Centre, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Campbell', 'Affiliation': 'School of Applied Sciences, Edinburgh Napier University, Edinburgh, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Wolstenholme', 'Affiliation': 'Nuffield Department of Population Health, Health Economics Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Eleanora', 'Initials': 'E', 'LastName': 'Lovato', 'Affiliation': 'Nuffield Department of Population Health, Health Economics Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Campbell', 'Affiliation': 'National Perinatal Epidemiology Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Adams', 'Affiliation': 'Clinical Radiology, Faculty of Medicine Biology and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Speed', 'Affiliation': 'The School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Morris', 'Affiliation': 'Department of Medical Statistics, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Howell', 'Affiliation': 'Manchester Breast Centre, Manchester Cancer Research Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Howell', 'Affiliation': 'Prevent Breast Cancer Research Unit, The Nightingale Centre, Manchester University NHS Foundation Trust, Manchester, UK.'}]",British journal of cancer,['10.1038/s41416-019-0522-6']
959,32105411,Association of adoption of transradial access for percutaneous coronary intervention in ST elevation myocardial infarction with door-to-balloon time.,"OBJECTIVES


We aimed to study adoption of transradial primary percutaneous coronary intervention (TR-PPCI) for ST elevation myocardial infarction (STEMI) (""radial first"" approach) and its association with door-to-balloon time (D2BT).
BACKGROUND


TR-PPCI for STEMI is underutilized in the United States due to concerns about prolonging D2BT. Whether operators and hospitals adopting a radial first approach in STEMI incur prolonged D2BT is unknown.
METHODS


In 1,272 consecutive cases of STEMI with PPCI at our hospital from January 1, 2011, to December 31, 2016, we studied TR-PPCI adoption and its association with D2BT including a propensity matched analysis of similar risk TR-PPCI and trans-femoral primary PCI (TF-PPCI) patients.
RESULTS


With major increases in hospital-level TR-PPCI (hospital TR-PPCI rate: 2.6% in 2011 to 79.4% in 2016, p-trend<.001) and operator-level TR-PPCI (mean operator TR-PPCI rate: 2.9% in 2011 to 81.1% in 2016, p-trend = .005), median hospital level D2BT decreased from 102 min [81, 142] in 2011 to 84 min [60, 105] in 2016 (p-trend<.001). TF crossover (10.3%; n = 57) was not associated with unadjusted D2BT (TR-PPCI success 91 min [72, 112] vs. TF crossover 99 min [70, 115], p = .432) or D2BT adjusted for study year and presenting location (7.2% longer D2BT with TF crossover, 95% CI: -4.0% to +18.5%, p = .208). Among 273 propensity-matched pairs, unadjusted D2BT (TR-PPCI 98 [78, 117] min vs. TF-PPCI 101 [76, 132] min, p = .304), and D2BT adjusted for study year and presenting location (5.0% shorter D2BT with TR-PPCI, 95% CI: -12.4% to +2.4%, p = .188) were similar.
CONCLUSIONS


TR-PPCI can be successfully implemented without compromising D2BT performance.",2020,"RESULTS


With major increases in hospital-level TR-PPCI (hospital TR-PPCI rate: 2.6% in 2011 to 79.4% in 2016, p-trend<.001) and operator-level TR-PPCI (mean operator TR-PPCI rate: 2.9% in 2011 to 81.1% in 2016, p-trend = .005)","['1,272 consecutive cases of STEMI with PPCI at our hospital from January 1, 2011, to December 31, 2016, we studied TR-PPCI adoption and its association with D2BT including a propensity matched analysis of similar risk TR-PPCI and trans-femoral primary PCI (TF-PPCI) patients']","['percutaneous coronary intervention', 'transradial primary percutaneous coronary intervention (TR-PPCI']","['hospital-level TR-PPCI (hospital TR-PPCI rate', 'operator-level TR-PPCI', 'D2BT performance', 'median hospital level D2BT']","[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.0342675,"RESULTS


With major increases in hospital-level TR-PPCI (hospital TR-PPCI rate: 2.6% in 2011 to 79.4% in 2016, p-trend<.001) and operator-level TR-PPCI (mean operator TR-PPCI rate: 2.9% in 2011 to 81.1% in 2016, p-trend = .005)","[{'ForeName': 'Chetan P', 'Initials': 'CP', 'LastName': 'Huded', 'Affiliation': 'Heart and Vascular Institute Center for Healthcare Delivery Innovation, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Samir R', 'Initials': 'SR', 'LastName': 'Kapadia', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Jad A', 'Initials': 'JA', 'LastName': 'Ballout', 'Affiliation': 'Medicine Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Krishnaswamy', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Ellis', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Raymond', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Cho', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Conrad', 'Initials': 'C', 'LastName': 'Simpfendorfer', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bajzer', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Nair', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'A Michael', 'Initials': 'AM', 'LastName': 'Lincoff', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Kravitz', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Venu', 'Initials': 'V', 'LastName': 'Menon', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hantz', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Umesh N', 'Initials': 'UN', 'LastName': 'Khot', 'Affiliation': 'Heart and Vascular Institute Center for Healthcare Delivery Innovation, Cleveland Clinic, Cleveland, Ohio.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28785']
960,31845007,Pilot study of a telehealth perioperative physical activity intervention for older adults with cancer and their caregivers.,"BACKGROUND


Older adults undergoing cancer surgery are at greater risk for poor postoperative outcomes. Caregivers also endure significant burden. Participation in perioperative physical activity may improve physical functioning and enhance overall well-being for both patients and caregivers. In this study, we assessed the feasibility of a personalized telehealth intervention to enhance physical activity for older (≥ 65 years) gastrointestinal (GI) and lung cancer surgery patients/caregivers.
METHODS


Participants completed four telehealth sessions with physical therapy/occupational therapy (PT/OT) before surgery and up to 2 weeks post-discharge. Outcomes included preop geriatric assessment, functional measures, and validated measures for symptoms and psychological distress. Pre/post-intervention trends/trajectories for outcomes were explored.
RESULTS


Thirty-four patient/caregiver dyads (16, GI; 18, lung) were included. Accrual rate was 76% over 8 months; retention rate was 88% over 2 months. Median for postop of a 6-min walk test, timed up and go, and short physical performance battery test scores improved from baseline to postop. Participant satisfaction scores were high.
CONCLUSION


Our conceptually based, personalized, multimodal, telehealth perioperative physical activity intervention for older patient/caregiver dyads is feasible and acceptable. It offers an opportunity to improve postoperative outcomes by promoting functional recovery through telehealth, behavior change, and self-monitoring approaches.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03267524.",2020,"Median for postop of a 6-min walk test, timed up and go, and short physical performance battery test scores improved from baseline to postop.","['Thirty-four patient/caregiver dyads (16', '65\xa0years) gastrointestinal (GI) and lung cancer surgery patients/caregivers', 'older patient/caregiver dyads', 'Participants completed four', 'older adults with cancer and their caregivers', 'older (≥', 'Older adults undergoing cancer surgery']","['telehealth perioperative physical activity intervention', 'telehealth sessions with physical therapy/occupational therapy (PT/OT', 'personalized telehealth intervention']","['retention rate', 'preop geriatric assessment, functional measures, and validated measures for symptoms and psychological distress', 'Median for postop of a 6-min walk test, timed up and go, and short physical performance battery test scores', 'Participant satisfaction scores', 'Accrual rate']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0920424'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0017463', 'cui_str': 'Geriatric Assessment'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0476829,"Median for postop of a 6-min walk test, timed up and go, and short physical performance battery test scores improved from baseline to postop.","[{'ForeName': 'Kelly J', 'Initials': 'KJ', 'LastName': 'Lafaro', 'Affiliation': 'Department of Surgery, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Dan J', 'Initials': 'DJ', 'LastName': 'Raz', 'Affiliation': 'Department of Surgery, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Jae Y', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Hite', 'Affiliation': 'Department of Rehabilitation, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Ruel', 'Affiliation': 'Department of Information Sciences, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Gouri', 'Initials': 'G', 'LastName': 'Varatkar', 'Affiliation': 'Department of Rehabilitation, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Erhunmwunsee', 'Affiliation': 'Department of Surgery, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Laleh', 'Initials': 'L', 'LastName': 'Melstrom', 'Affiliation': 'Department of Surgery, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Byrne', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Gagandeep', 'Initials': 'G', 'LastName': 'Singh', 'Affiliation': 'Department of Surgery, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Yuman', 'Initials': 'Y', 'LastName': 'Fong', 'Affiliation': 'Department of Surgery, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Sun', 'Affiliation': 'Department of Surgery, City of Hope, Duarte, CA, USA. vsun@coh.org.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05230-0']
961,32045616,Predictors of overall and test-specific colorectal Cancer screening adherence.,"This study investigated predictors of overall and test-specific colorectal cancer screening (CRCS). Stool blood test (SBT) and/or colonoscopy screening were offered to primary care patients in two randomized controlled trials which assessed the impact of behavioral interventions on screening. Data were obtained through surveys and electronic medical records. Among 1942 participants, 646 (33%) screened. Exposure to interventions was associated with higher overall CRCS by twofold to threefold; older age, African American race, being married, and having a higher screening decision stage were also associated with higher overall CRCS (odds ratios = 1.30, 1.31, 1.34, and 5.59, respectively). Intervention, older age, female gender, and being married were associated with higher SBT adherence, while preference for colonoscopy was associated with lower SBT adherence. Intervention and higher decision stage were associated with higher colonoscopy adherence, while preference for SBT was associated with lower colonoscopy adherence. Among older individuals, African Americans had higher overall CRCS than whites, but this was not true among younger individuals (interaction p = .041). The higher screening adherence of African Americans over whites was due to stronger screening with a non-preferred test, i.e., higher SBT adherence only among individuals who preferred colonoscopy and higher colonoscopy adherence only among individuals who preferred SBT. Intervention exposure, sociodemographic background, and screening decision stage predicted overall CRCS adherence. Gender and test preference also affected test-specific screening adherence. Interactions involving race and test preference suggest that it is important to provide both colonoscopy and SBT screening options to patients, particularly African Americans.",2020,"Intervention and higher decision stage were associated with higher colonoscopy adherence, while preference for SBT was associated with lower colonoscopy adherence.","['1942 participants, 646 (33%) screened', 'patients, particularly African Americans', 'older individuals, African Americans', 'African Americans over whites']","['specific colorectal cancer screening (CRCS', 'Stool blood test (SBT) and/or colonoscopy screening']","['SBT adherence', 'overall CRCS', 'overall CRCS adherence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0329383,"Intervention and higher decision stage were associated with higher colonoscopy adherence, while preference for SBT was associated with lower colonoscopy adherence.","[{'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Daskalakis', 'Affiliation': 'Thomas Jefferson University, Department of Pharmacology & Experimental Therapeutics, Division of Biostatistics, United States of America. Electronic address: constantine.daskalakis@jefferson.edu.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'DiCarlo', 'Affiliation': 'Thomas Jefferson University, Department of Medical Oncology, Division of Population Science, United States of America.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hegarty', 'Affiliation': 'Thomas Jefferson University, Department of Pharmacology & Experimental Therapeutics, Division of Biostatistics, United States of America.'}, {'ForeName': 'Anuragh', 'Initials': 'A', 'LastName': 'Gudur', 'Affiliation': 'Drexel University College of Medicine, United States of America.'}, {'ForeName': 'Sally W', 'Initials': 'SW', 'LastName': 'Vernon', 'Affiliation': 'University of Texas School of Public Health, Center for Health Promotion and Prevention Research, Division of Health Promotion and Behavioral Sciences, United States of America.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'Myers', 'Affiliation': 'Thomas Jefferson University, Department of Medical Oncology, Division of Population Science, United States of America.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106022']
962,32436761,Glyceryl trinitrate in first-episode psychosis unmedicated with antipsychotics: A randomised controlled pilot study.,"BACKGROUND


There is a pressing need for new classes of treatment for psychosis. A key therapeutic target for novel compounds is the NMDA receptor, which may be modulated by nitric oxide donors such as sodium nitroprusside (SNP). Recent studies of SNP in patients with psychosis have mixed results, and the drug has to be administered intravenously. Glyceryl trinitrate (GTN) is a well-established cardiovascular medicine that is also a nitric oxide donor, and can be given orally.
AIMS


We explored the safety and potential effects of GTN in unmedicated patients with a first episode of psychosis.
METHODS


This was a single-centre, randomised, double-blind, placebo-controlled trial from December 2016 to April 2019 (ClinicalTrials.gov identifier: NCT02906553). Patients received 3 × sprays of GTN or placebo for three consecutive days, and were re-assessed on Days 1, 2, 3 and 7. The primary outcome was cognition (Jumping to Conclusions task), secondary outcomes were symptoms (Positive and Negative Syndrome Scale (PANSS)), verbal memory (Hopkins Verbal Learning task), and mood (Bond-Lader Visual Analogue Scales).
RESULTS


Nineteen patients were randomised, and 13 participants were included in the analyses. Compared with placebo, GTN was well tolerated, but was not associated with significant effects on cognition, symptoms, or mood. Bayesian statistics indicate that our results were 2× more likely under the null hypothesis than the alternative hypothesis, providing anecdotal evidence that GTN does not improve psychotic symptoms.
CONCLUSIONS


We found no indication of an effect of GTN on symptoms of psychosis or cognition.",2020,"Compared with placebo, GTN was well tolerated, but was not associated with significant effects on cognition, symptoms, or mood.","['Nineteen patients were randomised, and 13 participants were included in the analyses', 'patients with psychosis', 'unmedicated patients with a first episode of psychosis', 'controlled trial from December 2016 to April 2019 (ClinicalTrials.gov identifier', 'first-episode psychosis unmedicated with antipsychotics']","['GTN', 'Glyceryl trinitrate (GTN', 'SNP', 'placebo, GTN', '3 × sprays of GTN or placebo', 'Glyceryl trinitrate', 'placebo']","['tolerated', 'cognition (Jumping to Conclusions task), secondary outcomes were symptoms (Positive and Negative Syndrome Scale (PANSS)), verbal memory (Hopkins Verbal Learning task), and mood (Bond-Lader Visual Analogue Scales', 'symptoms of psychosis or cognition', 'psychotic symptoms', 'cognition, symptoms, or mood']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0037533', 'cui_str': 'Sodium nitroprusside'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}]",19.0,0.469584,"Compared with placebo, GTN was well tolerated, but was not associated with significant effects on cognition, symptoms, or mood.","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Merritt', 'Affiliation': 'Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, London, UK.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Catalan', 'Affiliation': 'Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, London, UK.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Cowley', 'Affiliation': 'Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, London, UK.'}, {'ForeName': 'Arsime', 'Initials': 'A', 'LastName': 'Demjaha', 'Affiliation': 'Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, London, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, London, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'McGuire', 'Affiliation': 'Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, London, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Cooper', 'Affiliation': 'Newham Centre for Mental Health, Unit for Social and Community Psychiatry, Queen Mary University of London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Morrison', 'Affiliation': 'Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, London, UK.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120922967']
963,31021036,Randomized trial of facilitated subcutaneous immunoglobulin in multifocal motor neuropathy.,"BACKGROUND AND PURPOSE


To optimize subcutaneous therapy with immunoglobulins, large volume infusion of immunoglobulin G facilitated by pretreatment with hyaluronidase (fSCIG) was compared to conventional infusion of multiple small dosages (cSCIG) in 20 patients with multifocal motor neuropathy.
METHODS


A randomized, non-inferiority and observer-blinded cross-over design was applied with a treatment period of 24 weeks for each therapy.
RESULTS


In 18 patients fSCIG was feasible, two patients leaving the study due to side-effects. The primary study variable, isometric strength, was unchanged, being 100.8% [95% confidence interval (CI) 94.8%-107.1%) in fSCIG and 105.9% (95% CI 99.8%-112.0%) in cSCIG. Secondary end-points of disability, functions, impairments and quality of life showed no differences between the two treatments. Mild and short-lasting generalized side-effects were similar in the two groups, whereas the relative frequency of localized side-effects at the injection site was increased after fSCIG [0.63 (95% CI 0.23-1.00) vs. 0.09 (95% CI 0.00-0.22), P = 0.005]. The preference of the patients favoured fSCIG for two out of five visual analogue scale scores as well as the total mean score of all preferences (P = 0.03).
CONCLUSIONS


Facilitated SCIG seems effective, feasible and safe. In addition, it is preferred by patients but is accompanied by a higher frequency of short-lasting localized side-effects.",2019,"The primary study variable, isometric strength, was unchanged, being 100.8% [95% confidence interval (CI) 94.8%-107.1%) in fSCIG and 105.9% (95% CI 99.8%-112.0%) in cSCIG.","['20 patients with multifocal motor neuropathy', 'multifocal motor neuropathy']","['immunoglobulin G facilitated by pretreatment with hyaluronidase (fSCIG', 'conventional infusion of multiple small dosages (cSCIG', 'facilitated subcutaneous immunoglobulin']","['isometric strength', 'effective, feasible and safe', 'Mild and short-lasting generalized side-effects', 'disability, functions, impairments and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0393847', 'cui_str': 'Motor neuropathy with multiple conduction block (disorder)'}]","[{'cui': 'C0202087', 'cui_str': 'Immunoglobulin G measurement (procedure)'}, {'cui': 'C0020197', 'cui_str': 'Hyaluronidase'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0021027', 'cui_str': 'Immune Globulins'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0034380'}]",20.0,0.118924,"The primary study variable, isometric strength, was unchanged, being 100.8% [95% confidence interval (CI) 94.8%-107.1%) in fSCIG and 105.9% (95% CI 99.8%-112.0%) in cSCIG.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Al-Zuhairy', 'Affiliation': 'Department of Neurology, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jakobsen', 'Affiliation': 'Department of Neurology, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Andersen', 'Affiliation': 'Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Sindrup', 'Affiliation': 'Department of Neurology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'L K', 'Initials': 'LK', 'LastName': 'Markvardsen', 'Affiliation': 'Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}]",European journal of neurology,['10.1111/ene.13978']
964,31937586,Effect of rovatirelin in patients with cerebellar ataxia: two randomised double-blind placebo-controlled phase 3 trials.,"OBJECTIVE


To investigate the efficacy of rovatirelin, a thyrotropin-releasing hormone analogue, for ataxias in patients with spinocerebellar degeneration (SCD).
METHODS


Two multicentre, randomised, double-blind, placebo-controlled phase 3 studies (KPS1301, KPS1305) enrolled patients with predominant cerebellar ataxia, including SCA6, SCA31 or cortical cerebellar atrophy. KPS1301 enrolled patients with truncal ataxia and KPS1305 enrolled patients with truncal and limb ataxia. Each study included 4 weeks of pretreatment, a 28-week or 24-week treatment period and 4 weeks of follow-up. Patients were randomised (1:1:1) to rovatirelin (1.6 or 2.4 mg) or placebo in KPS1301, and randomised (1:1) to rovatirelin 2.4 mg or placebo in KPS1305. The primary endpoint was change in Scale for the Assessment and Rating of Ataxia (SARA) total scores. Pooled analysis was performed in patients who met the SARA recruitment criteria of KPS1305.
RESULTS


From October 2013 to May 2014, KPS1301 enrolled 411 patients; 374 were randomised to rovatirelin 1.6 mg (n=125), rovatirelin 2.4 mg (n=126) or placebo (n=123). From November 2016 to August 2017, KPS1305 enrolled 241 patients; 203 were randomised to rovatirelin 2.4 mg (n=101) or placebo (n=102). The primary endpoint showed no significant difference between rovatirelin and placebo in these two studies. In the pooled analysis (n=278), the difference between rovatirelin 2.4 mg (n=140) and placebo (n=138) was -0.61 (-1.64 vs -1.03; 95% CI -1.16 to -0.06; p=0.029) in the adjusted mean change in the SARA total score.
CONCLUSIONS


Rovatirelin is a potentially effective treatment option for SCD.
TRIAL REGISTRATION NUMBER


NCT01970098; NCT02889302.",2020,The primary endpoint showed no significant difference between rovatirelin and placebo in these two studies.,"['patients with spinocerebellar degeneration (SCD', 'From October 2013 to May 2014, KPS1301 enrolled 411 patients; 374', 'patients with cerebellar ataxia', 'enrolled patients with predominant cerebellar ataxia, including SCA6, SCA31 or cortical cerebellar atrophy', 'From November 2016 to August 2017, KPS1305 enrolled 241 patients; 203', 'enrolled patients with truncal ataxia and KPS1305 enrolled patients with truncal and limb ataxia']","['placebo-controlled phase 3 studies (KPS1301, KPS1305', 'rovatirelin 1.6\u2009mg (n=125), rovatirelin 2.4\u2009mg (n=126) or placebo', 'placebo in KPS1301', 'rovatirelin, a thyrotropin-releasing hormone analogue', 'rovatirelin', 'rovatirelin 2.4\u2009mg (n=101) or placebo', 'placebo', 'KPS1301', 'rovatirelin 2.4\u2009mg or placebo in KPS1305']","['change in Scale for the Assessment and Rating of Ataxia (SARA) total scores', 'SARA total score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037952', 'cui_str': 'Spinocerebellar Diseases'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}, {'cui': 'C0007758', 'cui_str': 'Cerebellar Incoordination'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0740279', 'cui_str': 'Cerebellar atrophy'}, {'cui': 'C0427190', 'cui_str': 'Ataxia, Truncal'}, {'cui': 'C0750937', 'cui_str': 'Ataxia, Appendicular'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4278752', 'cui_str': 'rovatirelin'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0040162', 'cui_str': 'protirelin'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0222045'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0004134', 'cui_str': 'Dyssynergia'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",411.0,0.652056,The primary endpoint showed no significant difference between rovatirelin and placebo in these two studies.,"[{'ForeName': 'Masatoyo', 'Initials': 'M', 'LastName': 'Nishizawa', 'Affiliation': 'Brain Research Institute, Niigata University, Niigata, Japan nishizawamasatoyo@gmail.com.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Onodera', 'Affiliation': 'Department of Neurology, Brain Research Institute, Niigata University, Niigata, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Hirakawa', 'Affiliation': 'Department of Biostatistics and Bioinformatics, The University of Tokyo, Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Shimizu', 'Affiliation': 'Strategic Alliance Department, Kissei Pharmaceutical Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Yamada', 'Affiliation': 'Clinical Data Science Department, Kissei Pharmaceutical Co., Ltd, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2019-322168']
965,31929469,High-intensity interval training induced PGC-1∝ and AdipoR1 gene expressions and improved insulin sensitivity in obese individuals.,"INTRODUCTION


High-intensity interval training (HIIT) has been found to improve cardiometabolic health outcome as compared to moderate-intensity continuous exercise. However, there is still limited data on the benefits of HIIT on the expression of regulatory proteins that are linked to skeletal muscle metabolism and insulin sensitivity in obese adults. This study investigated the effects of HIIT intervention on expressions of peroxisome proliferatoractivated receptor-γ coactivator 1-∝ (PGC-1∝) and adiponectin receptor-1 (AdipoR1), insulin sensitivity (HOMAIR index), and body composition in overweight/obese individuals.
METHODS


Fifty overweight/obese individuals aged 22-29 years were assigned to either no-exercise control (n=25) or HIIT (n=25) group. The HIIT group underwent a 12-week intervention, three days/week, with intensity of 65-80% of age-based maximum heart rate. Anthropometric measurements, homeostatic model of insulin resistance (HOMA-IR) and gene expression analysis were conducted at baseline and post intervention.
RESULTS


Significant time-by-group interactions (p<0.001) were found for body weight, BMI, waist circumference and body fat percentage. The HIIT group had lower body weight (2.3%, p<0.001), BMI (2.7%, p<0.001), waist circumference (2.4%, p<0.001) and body fat percentage (4.3%, p<0.001) post intervention. Compared to baseline, expressions of PGC-1∝ and AdipoR1 were increased by approximately three-fold (p=0.019) and two-fold (p=0.003) respectively, along with improved insulin sensitivity (33%, p=0.019) in the HIIT group.
CONCLUSION


Findings suggest that HIIT possibly improved insulin sensitivity through modulation of PGC-1∝ and AdipoR1. This study also showed that improved metabolic responses can occur despite modest reduction in body weight in overweight/obese individuals undergoing HIIT intervention.",2019,"The HIIT group had lower body weight (2.3%, p<0.001), BMI (2.7%, p<0.001), waist circumference (2.4%, p<0.001) and body fat percentage (4.3%","['n=25) or HIIT (n=25) group', 'Fifty overweight/obese individuals aged 22-29 years', 'obese adults', 'overweight/obese individuals', 'overweight/obese individuals undergoing HIIT intervention', 'obese individuals']","['no-exercise control', 'HIIT intervention', 'PGC-1∝', 'High-intensity interval training (HIIT']","['body weight, BMI, waist circumference and body fat percentage', 'expressions of peroxisome proliferatoractivated receptor-γ coactivator 1-∝ (PGC-1∝) and adiponectin receptor-1 (AdipoR1), insulin sensitivity (HOMAIR index), and body composition', 'BMI', 'insulin sensitivity', 'expressions of PGC-1∝ and AdipoR1', 'Anthropometric measurements, homeostatic model of insulin resistance (HOMA-IR) and gene expression analysis', 'waist circumference', 'lower body weight', 'body fat percentage', 'cardiometabolic health outcome', 'body weight']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0752063'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1955918', 'cui_str': 'Receptors, Adiponectin'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0478056,"The HIIT group had lower body weight (2.3%, p<0.001), BMI (2.7%, p<0.001), waist circumference (2.4%, p<0.001) and body fat percentage (4.3%","[{'ForeName': 'N H', 'Initials': 'NH', 'LastName': ""Asilah Za'don"", 'Affiliation': 'Universiti Kebangsaan Malaysia, Faculty of Health Sciences, Center for Health and Applied Sciences, Bandar Tun Razak, Cheras, Kuala Lumpur, Malaysia. arimifitri@ukm.edu.my.'}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Amirul Farhana', 'Affiliation': 'University Selangor (UNISEL), Faculty of Engineering and Life Sciences, Department of Health Sciences, Shah Alam, Selangor Darul Ehsan, Malaysia.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Farhanim', 'Affiliation': 'Universiti Teknologi Mara (UiTM), Faculty of Sport Science & Recreation, Shah Alam, Selangor, Malaysia.'}, {'ForeName': 'T O', 'Initials': 'TO', 'LastName': 'Sharifah Izwan', 'Affiliation': 'University Selangor (UNISEL), Faculty of Engineering and Life Sciences, Department of Health Sciences, Shah Alam, Selangor Darul Ehsan, Malaysia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Appukutty', 'Affiliation': 'Universiti Teknologi Mara (UiTM), Faculty of Sport Science & Recreation, Shah Alam, Selangor, Malaysia.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Salim', 'Affiliation': 'Universiti Teknologi Mara (UiTM), Faculty of Medicine, Institute of Medical Molecular Biotechnology, Shah Alam, Selangor, Malaysia.'}, {'ForeName': 'N M F', 'Initials': 'NMF', 'LastName': 'Farah', 'Affiliation': 'Universiti Kebangsaan Malaysia, Faculty of Health Sciences, Center for Community Health, Bandar Tun Razak, Cheras, Kuala Lumpur, Malaysia.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Arimi Fitri', 'Affiliation': 'Universiti Kebangsaan Malaysia, Faculty of Health Sciences, Center for Healthy Ageing & Wellness, Bandar Tun Razak, Cheras, Kuala Lumpur, Malaysia.'}]",The Medical journal of Malaysia,[]
966,32436724,Evaluation of a brief interval exercise training (IET) intervention for first-time prisoners with elevated anxiety symptoms.,"ABSTRACT   Background:  Exercise training has a history of alleviating anxiety in various populations, but research into its effects on prison inmates is limited. Confinement to prison is a highly distressing event for those who have never experienced incarceration, which can dramatically increase anxiety-related symptoms and may exacerbate suicidal risk.  Methods:  Thirty-seven first-time prisoners with elevated anxiety symptoms completed the State-Trait Anxiety Inventory before and after a 6-week long treatment period consisting of interval exercise training (IET;  n  = 20) or no intervention (waiting-list;  n  = 17). Prisoners in the IET intervention had to exercise three times per week (40 min per session) under the supervision of the first and/or second author. Exercise intensity was self-monitored using the Borg's RPE-15 scale, with targets in the range 13-15 (""somewhat hard""-""hard"").  Results:  Those who received the IET intervention showed a significantly greater reduction in anxiety than prisoners in the waiting-list. The effect size for IET was of moderate-to-large magnitude (Cohen's  d  = -0.71).  Conclusion:  The authors conclude that the lower levels of anxiety reported following IET suggest that supervised exercise training is an effective coping strategy to deal with incarceration.  Trial registration:  ClinicalTrials.gov identifier: NCT04019171.",2020,showed a significantly greater reduction in anxiety than prisoners in the waiting-list.,"['Thirty-seven first-time prisoners with elevated anxiety symptoms completed the State-Trait Anxiety Inventory before and after a 6-week long treatment period consisting of', 'first-time prisoners with elevated anxiety symptoms']","['IET intervention', 'brief interval exercise training (IET) intervention', 'Exercise training', 'supervised exercise training', 'interval exercise training (IET;  n \u2009=\u200920) or no intervention (waiting-list;  n \u2009=\u200917']",['anxiety'],"[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0491,showed a significantly greater reduction in anxiety than prisoners in the waiting-list.,"[{'ForeName': 'Fabien D', 'Initials': 'FD', 'LastName': 'Legrand', 'Affiliation': 'Department of Psychology, C2S, EA 6291, Université de Reims Champagne Ardenne, Reims, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Ory', 'Affiliation': 'Department of Psychology, C2S, EA 6291, Université de Reims Champagne Ardenne, Reims, France.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Herring', 'Affiliation': 'Department of Physical Education and Sports Sciences, Health Research Institute, University of Limerick, Limerick, Ireland.'}]","Anxiety, stress, and coping",['10.1080/10615806.2020.1768244']
967,32435906,Evaluation of the effects of photobiomodulation therapy and ozone applications after gingivectomy and gingivoplasty on postoperative pain and patients' oral health-related quality of life.,"The aim of this study was to evaluate the effects of photobiomodulation therapy (PBM) and ozone applications on patients' quality of life after gingivectomy and gingivoplasty. In this study, 36 patients with chronic inflammatory gingival enlargement underwent gingivectomy and gingivoplasty. The groups were randomly divided into control (n = 12), PBM (n = 12) and ozone (n = 12) groups. GaAlAs diode laser 810 nm wavelength at a non-contact and continuous mode with a power of 0.3 W and a density of 4 J/cm 2  used for PBM for 1 min. Ozone was applied for 1 min for every 5 mm 2  in contact mode at power level 9 using probe number 3. PBM and ozone applications were performed immediately after the operation, on the 3rd and 7th days. Pain assessment was performed at 3rd, 7th, 14th and 28th days after gingivectomy and gingivoplasty by using visual analogue scale (VAS). Oral Health Impact Profile (OHIP-14) records were obtained from the patients before gingivectomy and gingivoplasty and postoperative 7th and 14th days. OHIP-14 questions were also evaluated individually. VAS pain levels of the control group measured on the 3rd day were higher than the PBM group and on the 7th day were found to be significantly higher than both groups (p < 0.05). The total OHIP-14 score of the control group on the 7th postoperative day was found to be higher than the PBM group (p < 0.05). The mean score obtained from the third question of OHIP-14 at 7th and 14th day of the PBM group was found to be lower than the control and ozone groups (p < 0.05). The PBM and ozone applications after gingivectomy and gingivoplasty reduce the pain levels of patients and have a positive effect on patients' quality of life.",2020,VAS pain levels of the control group measured on the 3rd day were higher than the PBM group and on the 7th day were found to be significantly higher than both groups (p < 0.05).,"[""patients' quality of life after gingivectomy and gingivoplasty"", '36 patients with chronic inflammatory gingival enlargement underwent gingivectomy and gingivoplasty']","['photobiomodulation therapy and ozone applications after gingivectomy and gingivoplasty', 'GaAlAs diode laser 810', 'photobiomodulation therapy (PBM) and ozone applications', 'PBM']","[""postoperative pain and patients' oral health-related quality of life"", 'pain levels', 'total OHIP-14 score', 'Pain assessment', 'VAS pain levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0017573', 'cui_str': 'Gingivectomy'}, {'cui': 'C0017576', 'cui_str': 'Gingivoplasty'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0017566', 'cui_str': 'Hyperplasia of gingiva'}]","[{'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0017573', 'cui_str': 'Gingivectomy'}, {'cui': 'C0017576', 'cui_str': 'Gingivoplasty'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",36.0,0.014578,VAS pain levels of the control group measured on the 3rd day were higher than the PBM group and on the 7th day were found to be significantly higher than both groups (p < 0.05).,"[{'ForeName': 'Mustafa Özay', 'Initials': 'MÖ', 'LastName': 'Uslu', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Inonu University, 44280, Malatya, Turkey. mustafaozayuslu@hotmail.com.'}, {'ForeName': 'Semih', 'Initials': 'S', 'LastName': 'Akgül', 'Affiliation': 'Malatya Şehit Mehmet Kılınç Oral And Dental Health Hospital, 44280, Malatya, Turkey.'}]",Lasers in medical science,['10.1007/s10103-020-03037-8']
968,31929472,Comparison of the efficacy and level of adherence for morning versus evening versus before bedtime administration of simvastatin in hypercholesterolemic patients.,"BACKGROUND


Simvastatin is usually taken in the evening due to the circadian rhythm of hepatic cholesterol biosynthesis. The degree of reduction of low-density lipoprotein cholesterol (LDL-C) and the level of adherence to different administration time remained unknown in the Malaysian population. This study aims to investigate the effect of simvastatin on the percentage changes of lipid profile and the level of adherence to when simvastatin was instructed to be taken at different timing.
METHODS


Nine primary care health clinics across Malaysia participated in this study. 147 statin-naive subjects were selected through convenient sampling and randomised into one of the three arms (after breakfast, after dinner or before bedtime). Differences on percentage reduction of LDL-C from baseline and level of adherence among the three groups at week-16 were compared. The main outcomes measured in this study were the percentage change of lipid parameters and the percentage of high-adherence (MMAS=8) at week-16.
RESULTS


59.2% of the patients were male. The mean age of the study population was 53.93± 10.85 years. Most of the patients were Malays (69.4%); followed by Indians (22.4%) and Chinese (8.2%). LDL-C decreased from 4.26 (Standard Deviation, SD1.01) to 2.36 (SD0.69)mmol/L at week-16 for patients taking simvastatin before bedtime; an absolute reduction of 44.95%.The differences of LDL-C percentage reduction between three arms were significantly different (p<0.001). The greatest LDL-C reduction was observed when simvastatin was taken before bedtime and revealed 56.2% patients with high-adherence at week-16.
CONCLUSION


Simvastatin showed superior LDL-reduction and higher level of adherence when being instructed to be taken before bedtime.",2019,The degree of reduction of low-density lipoprotein cholesterol (LDL-C) and the level of adherence to different administration time remained unknown in the Malaysian population.,"['hypercholesterolemic patients', 'Nine primary care health clinics across Malaysia participated in this study', '147 statin-naive subjects']","['Simvastatin', 'simvastatin']","['LDL-C', 'greatest LDL-C reduction', 'superior LDL-reduction and higher level of adherence', 'LDL-C percentage reduction', 'efficacy and level of adherence', 'LDL-C from baseline and level of adherence', 'percentage change of lipid parameters and the percentage of high-adherence (MMAS=8', 'degree of reduction of low-density lipoprotein cholesterol (LDL-C']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}]","[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}]",147.0,0.0862477,The degree of reduction of low-density lipoprotein cholesterol (LDL-C) and the level of adherence to different administration time remained unknown in the Malaysian population.,"[{'ForeName': 'W K', 'Initials': 'WK', 'LastName': 'Heng', 'Affiliation': 'AIMST University, Faculty of Pharmacy, Bedong, Kedah, Malaysia. yenpingng@hotmail.com.'}, {'ForeName': 'Y P', 'Initials': 'YP', 'LastName': 'Ng', 'Affiliation': 'AIMST University, Faculty of Pharmacy, Clinical Pharmacy, Bedong, Kedah, Malaysia.'}, {'ForeName': 'G S', 'Initials': 'GS', 'LastName': 'Ooi', 'Affiliation': 'Science University of Malaysia, Discipline of Clinical Pharmacy, Gelugor, Penang, Malaysia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Habshoh', 'Affiliation': 'Bandar Sungai Petani Health Clinic, Department of Family Medicine, Sungai Petani, Kedah, Malaysia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nurazlin', 'Affiliation': 'Taiping Health Clinic, Department of Family Medicine, Taiping, Perak, Malaysia.'}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Nor Azah', 'Affiliation': 'Bakar Arang Health Clinic, Department of Family Medicine, Batu Arang, Selangor, Malaysia.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hasniza', 'Affiliation': 'Merbok Health Clinic, Department of Family Medicine, Kuala Muda, Kedah, Malaysia.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Noriza', 'Affiliation': 'Bedong Health Clinic, Department of Family Medicine Specialist, Bedong, Kedah, Malaysia.'}]",The Medical journal of Malaysia,[]
969,32435018,[USEFULNESS OF RUPATADINE FOR PRURITUS OF PATIENTS WITH ATOPIC DERMATITIS].,"BACKGROUND


Histamine H1 receptor antagonists (antihistamines) are recommended as adjunctive therapy for atopic dermatitis (AD). However, their long-term usefulness and the effect of updosing have not been clarified.
PURPOSE


To analyzed the long-term usefulness and the effect of updosing of rupatadine, a second generation antihistamine, for patients with AD.
METHODS


Efficacy and safety of rupatadine were evaluated in 66 AD patients, including 50 patients with dose escalation by post hoc analysis of the phase III trial of rupatadine for Japanese patients with pruritus associated with skin diseases.
RESULTS


The mean score at baseline total pruritus score (TPS) was 4.682. It decreased to 3.885 at 2 weeks, and 2.376 at 52 weeks by rupatadine administration. The change (of one week after baseline TPS) was significant. Baseline TPS of dose escalation groups, either after 2 weeks or after week 4, were higher than those of 10mg maintenance dose cases, but no significant difference was shown in the change from baseline TPS among the groups at 52 weeks. The occurrence of adverse drug reactions and somnolence were observed in 19.7% and 15.2% of the subjects.
CONCLUSION


These results suggest the long-term usefulness of rupatadine for pruritus in AD.",2020,"The occurrence of adverse drug reactions and somnolence were observed in 19.7% and 15.2% of the subjects.
","['atopic dermatitis (AD', 'patients with AD', '66 AD patients, including 50 patients with dose escalation by post hoc analysis of the phase III trial of rupatadine for Japanese patients with pruritus associated with skin diseases']","['rupatadine', 'Histamine H1 receptor antagonists (antihistamines', 'rupatadine, a second generation antihistamine']","['occurrence of adverse drug reactions and somnolence', 'mean score at baseline total pruritus score (TPS']","[{'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0534301', 'cui_str': 'rupatadine'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}]","[{'cui': 'C0534301', 'cui_str': 'rupatadine'}, {'cui': 'C0019592', 'cui_str': 'Histamine H1 receptor antagonist'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}, {'cui': 'C1136312', 'cui_str': 'Second Generation H1 Antagonists'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033774', 'cui_str': 'Itching'}]",66.0,0.0566319,"The occurrence of adverse drug reactions and somnolence were observed in 19.7% and 15.2% of the subjects.
","[{'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Hide', 'Affiliation': 'Department of Dermatology, Graduate School of Biomedical and Health Sciences, Hiroshima University.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Hirata', 'Affiliation': 'Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation.'}, {'ForeName': 'Naruyasu', 'Initials': 'N', 'LastName': 'Komorita', 'Affiliation': 'Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Kubo', 'Affiliation': 'Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation.'}, {'ForeName': 'Takamasa', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Clinical Development & Regulatory Strategy Center, Teikoku Seiyaku CO LTD.'}, {'ForeName': 'Ayaka', 'Initials': 'A', 'LastName': 'Tanaka', 'Affiliation': 'Clinical Development & Regulatory Strategy Center, Teikoku Seiyaku CO LTD.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Aoki', 'Affiliation': 'Clinical Development & Regulatory Strategy Center, Teikoku Seiyaku CO LTD.'}]",Arerugi = [Allergy],['10.15036/arerugi.69.174']
970,32071901,Age-Related Serum Thyroid-Stimulating Hormone Reference Range in Older Patients Treated with Levothyroxine: A Randomized Controlled Feasibility Trial (SORTED 1).,"Introduction


Serum thyroid-stimulating hormone (TSH) increases with age but target TSH is similar in younger and older hypothyroid patients on treatment. It is unknown if quality of life (QoL), hypothyroid symptoms and cardiovascular risk factors change in older hypothyroid patients treated to an age-appropriate reference range.
Objective


To assess if a higher target serum TSH of 4.01-8.0 mU/L is feasible in, and acceptable to, older treated hypothyroid patients.
Methods


A single-blind (participant) randomised controlled feasibility trial involving 48 hypothyroid patients aged ≥80 years on established and stable levothyroxine (LT4) therapy with serum TSH levels within the standard reference range (0.4-4.0 mU/L) was conducted. Standard (0.4-4.0 mU/L) or higher (4.1-8.0 mU/L) TSH target (standard TSH [ST] or higher TSH [HT] groups) LT4 for 24 weeks was administered. The outcome measures evaluated were thyroid function tests, QoL, hypothyroid symptoms, cardiovascular risk factors and serum marker of bone resorption in participants that completed the trial ( n  = 21/24 ST group,  n  = 19/24 HT group).
Results


At 24 weeks, in the ST and HT groups, respectively, median (interquartile range) serum TSH was 1.25 (0.76-1.72) and 5.50 (4.05-9.12) mU/L, mean (± SD) free thyroxine (FT4) was 19.4 ± 3.5 and 15.9 ± 2.4 pmol/L, and daily LT4 dose was 82.1 ± 26.4 and 59.2 ± 23.9 µg. There was no suggestion of adverse impact of a higher serum TSH in the HT group with regard to any of the outcomes assessed.
Conclusions


In hypothyroid patients aged ≥80 years on LT4 therapy for 24 weeks, there was no evidence that a higher target serum TSH was associated with an adverse impact on patient reported outcomes, cardiovascular risk factors or bone resorption marker over 24 weeks. Longer-term trials assessing morbidity and mortality outcomes and health-utility in this age group are feasible and should be performed.",2020,"There was no suggestion of adverse impact of a higher serum TSH in the HT group with regard to any of the outcomes assessed.
","['48 hypothyroid patients aged ≥80 years on established and stable levothyroxine (LT4) therapy with serum TSH levels within the standard reference range (0.4-4.0 mU/L) was conducted', 'older treated hypothyroid patients', 'older hypothyroid patients treated to an age-appropriate reference range', 'hypothyroid patients aged ≥80 years on']","['LT4 therapy', 'Introduction\n\n\nSerum thyroid-stimulating hormone (TSH', 'Levothyroxine']","['serum TSH', 'thyroid function tests, QoL, hypothyroid symptoms, cardiovascular risk factors and serum marker of bone resorption', 'cardiovascular risk factors or bone resorption marker', 'target serum TSH', 'median (interquartile range) serum TSH', 'morbidity and mortality outcomes and health-utility']","[{'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1881373', 'cui_str': ""L-3,5,3',5'-Tetraiodothyronine""}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1277938', 'cui_str': 'Serum TSH measurement'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0086715', 'cui_str': 'Normal Range'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0439342', 'cui_str': 'uU/mL'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1293116', 'cui_str': 'Introduction'}, {'cui': 'C0857986', 'cui_str': 'Serum thyroid stimulating hormone'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C1881373', 'cui_str': ""L-3,5,3',5'-Tetraiodothyronine""}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0040130', 'cui_str': 'Thyroid Gland Function Tests'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0162491', 'cui_str': 'Serum Markers'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",48.0,0.120906,"There was no suggestion of adverse impact of a higher serum TSH in the HT group with regard to any of the outcomes assessed.
","[{'ForeName': 'Salman', 'Initials': 'S', 'LastName': 'Razvi', 'Affiliation': 'Institute of Genetic Medicine, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Ryan', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Ingoe', 'Affiliation': 'Department of Endocrinology, Gateshead Health NHS Foundation Trust, Gateshead, United Kingdom.'}, {'ForeName': 'Simon H', 'Initials': 'SH', 'LastName': 'Pearce', 'Affiliation': 'Institute of Genetic Medicine, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Wilkes', 'Affiliation': 'School of Medicine, University of Sunderland, Sunderland, United Kingdom.'}]",European thyroid journal,['10.1159/000504047']
971,32034912,Acoustic closed-loop stimulation during sleep improves consolidation of reward-related memory information in healthy children but not in children with attention-deficit hyperactivity disorder.,"STUDY OBJECTIVES


Slow oscillations (SO) during slow-wave sleep foster the consolidation of declarative memory. Children with attention-deficit hyperactivity disorder (ADHD) display deficits in the sleep-associated consolidation of declarative memory, possibly due to an altered function of SO. The present study aimed at enhancing SO activity using closed-looped acoustic stimulation during slow-wave sleep in children with ADHD.
METHODS


A total of 29 male children (14 with ADHD; aged 8-12 years) participated in a double-blind, placebo-controlled study trial. Children spent two experimental nights in a sleep lab, one stimulation night and one sham night. A declarative learning task (word-pair learning) with a reward condition was used as a primary outcome. Secondary outcome variables were a procedural memory (serial reaction time) and working memory (WM; n-back) task. Encoding of declarative and procedural memory took place in the evening before sleep. After sleep, the retrieval took place followed by the n-back task.
RESULTS


The stimulation successfully induced SO activity during sleep in children with and without ADHD. After stimulation, only healthy children performed better on high-rewarded memory items (primary outcome). In contrast, there were indications that only children with ADHD benefitted from the stimulation with respect to procedural as well as WM performance (secondary outcome).
CONCLUSIONS


We were able to show that the acoustic closed-loop stimulation can be applied to enhance SO activity in children with and without ADHD. Our data indicate that SO activity during sleep interacts with subsequent memory performance (primary outcome: rewarded declarative memory; secondary outcome: procedural and WM) in children with and without ADHD.",2020,"Children with ADHD display deficits in the sleep-associated consolidation of declarative memory, possibly due to an altered function of SO.","['children with and without ADHD', 'children with ADHD', 'healthy children but not in children with ADHD', 'Twenty nine male children (14 with ADHD; aged 8-12 yrs']","['declarative learning task (word-pair learning', 'placebo', 'closed-looped acoustic stimulation', 'Acoustic closed-loop stimulation']","['procedural memory (serial reaction time) and working memory (n-back) task', 'SO activity', 'declarative memory, secondary outcome: procedural and working memory']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001164', 'cui_str': 'Stimulation, Auditory'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0561782', 'cui_str': 'Procedural memory (observable entity)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",29.0,0.082638,"Children with ADHD display deficits in the sleep-associated consolidation of declarative memory, possibly due to an altered function of SO.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Prehn-Kristensen', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Center for Integrative Psychiatry, School of Medicine, Christian-Albrechts-University, Kiel, Germany.'}, {'ForeName': 'Hong-Viet V', 'Initials': 'HV', 'LastName': 'Ngo', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Lentfer', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Center for Integrative Psychiatry, School of Medicine, Christian-Albrechts-University, Kiel, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Berghäuser', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Center for Integrative Psychiatry, School of Medicine, Christian-Albrechts-University, Kiel, Germany.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Brandes', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Center for Integrative Psychiatry, School of Medicine, Christian-Albrechts-University, Kiel, Germany.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Schulze', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Center for Integrative Psychiatry, School of Medicine, Christian-Albrechts-University, Kiel, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Göder', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Center for Integrative Psychiatry, School of Medicine, Christian-Albrechts-University, Kiel, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Mölle', 'Affiliation': 'Center of Brain, Behavior and Metabolism, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Lioba', 'Initials': 'L', 'LastName': 'Baving', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Center for Integrative Psychiatry, School of Medicine, Christian-Albrechts-University, Kiel, Germany.'}]",Sleep,['10.1093/sleep/zsaa017']
972,31501069,Effect of denture adhesives on oral moisture: A multicenter randomized controlled trial.,"PURPOSE


The purpose of this study was to investigate the effect of denture adhesives on oral moisture in a 10-center parallel randomized clinical trial.
METHODS


Two hundred edentulous subjects wearing complete dentures were allocated into three groups: cream-type adhesive, powder-type adhesive and control groups. The adhesives (and saline solution in the control group) were applied to the mucosal surface of the dentures for 4 days, and baseline data and data after the intervention for eight meals over 4 days were obtained. For the main outcome, oral moisture was measured with a moisture checking device. Secondary outcomes were denture satisfaction, masticatory performance, denture retention, and occlusal force. In addition to between-group and within-group comparisons of oral moisture, investigations for secondary outcomes were undertaken in subgroups classified according to the degree of oral moisture at baseline (normal subgroup and dry mouth subgroup). Intention-to-treat analysis was also performed.
RESULTS


Between-group and within-group comparisons of oral moisture showed no significant differences. The cream-type and powder-type denture adhesives were significantly effective in the dry mouth group for denture satisfaction ratings of ability to masticate, stability, retention, and comfort of mandibular dentures (p<0.05). The masticatory performance and retentive force of the dry mouth denture adhesive using groups were significantly improved after intervention (p<0.05).
CONCLUSIONS


The oral moisture of complete denture wearers was not influenced by the use of denture adhesives. Our findings showed that denture adhesives improved subjective denture satisfaction, masticatory performance, and retention for complete denture patients with oral dryness.",2020,"The masticatory performance and retentive force of the dry mouth denture adhesive using groups were significantly improved after intervention (p<0.05).
",['Two hundred edentulous subjects wearing complete dentures'],"['denture adhesives', 'cream-type adhesive, powder-type adhesive and control groups']","['subjective denture satisfaction, masticatory performance, and retention', 'masticatory performance and retentive force', 'denture satisfaction, masticatory performance, denture retention, and occlusal force', 'oral moisture', 'denture satisfaction ratings of ability to masticate, stability, retention, and comfort of mandibular dentures']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0026644', 'cui_str': 'Mouth, Toothless'}, {'cui': 'C0011455', 'cui_str': 'Denture, Complete'}]","[{'cui': 'C0011394', 'cui_str': 'Dentures'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0011394', 'cui_str': 'Dentures'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0011397', 'cui_str': 'Denture Retention'}, {'cui': 'C0005654', 'cui_str': 'Occlusal Force'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",200.0,0.112357,"The masticatory performance and retentive force of the dry mouth denture adhesive using groups were significantly improved after intervention (p<0.05).
","[{'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Nishi', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Oral and Maxillofacial Prosthodontics, Field of Oral and Maxillofacial Rehabilitation, Course for Advanced Therapeutics, Kagoshima University Graduate School of Medical and Dental Sciences, Sakuragaoka 8-35-1, Kagoshima 890-8544, Japan. Electronic address: shar@dent.kagoshima-u.ac.jp.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Nomura', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Prosthodontics and Oral Implantology, School of Dentistry, Iwate Medical University, 19-1 Uchimaru, Morioka 020-8505, Japan. Electronic address: tarou.nmr@gmail.com.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Murakami', 'Affiliation': 'The Japan Denture Care Society, Japan; Denture Prosthodontic Restoration, Advanced Dentistry Center, Kagoshima University Medical and Dental Hospital, Sakuragaoka 8-35-1, Kagoshima 890-8544, Japan. Electronic address: kaku@dent.kagoshima-u.ac.jp.'}, {'ForeName': 'Yasuhiko', 'Initials': 'Y', 'LastName': 'Kawai', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, 2-870-1 Sakaecho-nishi, Matsudo, Chiba 271-8587, Japan. Electronic address: kawai.yasuhiko@nihon-u.ac.jp.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nishimura', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Oral and Maxillofacial Prosthodontics, Field of Oral and Maxillofacial Rehabilitation, Course for Advanced Therapeutics, Kagoshima University Graduate School of Medical and Dental Sciences, Sakuragaoka 8-35-1, Kagoshima 890-8544, Japan. Electronic address: mnishi@dent.kagoshima-u.ac.jp.'}, {'ForeName': 'Hisatomo', 'Initials': 'H', 'LastName': 'Kondo', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Prosthodontics and Oral Implantology, School of Dentistry, Iwate Medical University, 19-1 Uchimaru, Morioka 020-8505, Japan. Electronic address: hkondo@iwate-med.ac.jp.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'The Japan Denture Care Society, Japan; Division of Aging and Geriatric Dentistry, Tohoku University Graduate School of Dentistry, 4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan. Electronic address: y-itoh@dent.tohoku.ac.jp.'}, {'ForeName': 'Akito', 'Initials': 'A', 'LastName': 'Tsuboi', 'Affiliation': 'The Japan Denture Care Society, Japan; Division of Community Oral Health Science, Department of Community Medical Supports, Tohoku Medical Megabank Organization, Tohoku University, 2-1 Seiryo-machi, Aoba-ku, Sendai 980-8573, Japan. Electronic address: tsuboi@m.tohoku.ac.jp.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Hong', 'Affiliation': 'The Japan Denture Care Society, Japan; Liaison Center for Innovative Dentistry, Tohoku University Graduate School of Dentistry, 4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan. Electronic address: hong@m.tohoku.ac.jp.'}, {'ForeName': 'Suguru', 'Initials': 'S', 'LastName': 'Kimoto', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, 2-870-1 Sakaecho-nishi, Matsudo, Chiba 271-8587, Japan. Electronic address: kimoto.suguru@nihon-u.ac.jp.'}, {'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Gunji', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, 2-870-1 Sakaecho-nishi, Matsudo, Chiba 271-8587, Japan. Electronic address: gunji.atsuko@nihon-u.ac.jp.'}, {'ForeName': 'Asako', 'Initials': 'A', 'LastName': 'Suzuki', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Removable Prosthodontics, Nihon University Graduate School of Dentistry at Matsudo, 2-870-1 Sakaecho-nishi, Matsudo, Chiba 271-8587, Japan. Electronic address: maas14013@g.nihon-u.ac.jp.'}, {'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Ohwada', 'Affiliation': 'The Japan Denture Care Society, Japan; Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo, Tokyo 113-8549, Japan. Electronic address: g.ohwada.gerd@tmd.ac.jp.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Minakuchi', 'Affiliation': 'The Japan Denture Care Society, Japan; Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo, Tokyo 113-8549, Japan. Electronic address: s.minakuchi.gerd@tmd.ac.jp.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'The Japan Denture Care Society, Japan; Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo, Tokyo 113-8549, Japan. Electronic address: y.sato.gerd@tmd.ac.jp.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'The Japan Denture Care Society, Japan; Section of Oral Prosthetic Engineering, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo, Tokyo 113-8549, Japan. Electronic address: suzuki.peoe@tmd.ac.jp.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Kimoto', 'Affiliation': 'The Japan Denture Care Society, Japan; Division of Prosthodontics & Oral Implantology, Department of Oral Interdisciplinary Medicine, Graduate School of Dentistry, Kanagawa Dental University, 82 Inaoka-cho, Yokosuka, Kanagawa 238-8580, Japan. Electronic address: k.kimoto@kdu.ac.jp.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Hoshi', 'Affiliation': 'The Japan Denture Care Society, Japan; Division of Prosthodontics & Oral Implantology, Department of Oral Interdisciplinary Medicine, Graduate School of Dentistry, Kanagawa Dental University, 82 Inaoka-cho, Yokosuka, Kanagawa 238-8580, Japan. Electronic address: hoshi@kdu.ac.jp.'}, {'ForeName': 'Makiko', 'Initials': 'M', 'LastName': 'Saita', 'Affiliation': 'The Japan Denture Care Society, Japan; Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo, Tokyo 113-8549, Japan. Electronic address: saita@kdu.ac.jp.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Yoneyama', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa 230-8501, Japan. Electronic address: yoneyama-y@tsurumi-u.ac.jp.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa 230-8501, Japan. Electronic address: sato-yohei@tsurumi-u.ac.jp.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Morokuma', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa 230-8501, Japan. Electronic address: info@morokumashika.com.'}, {'ForeName': 'Joji', 'Initials': 'J', 'LastName': 'Okazaki', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Removable Prosthodontics and Occlusion, Osaka Dental University, 1-5-17 Otemae, Chuo-ku, Osaka 540-0008, Japan. Electronic address: joji@cc.osaka-dent.ac.jp.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Maeda', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Removable Prosthodontics and Occlusion, Osaka Dental University, 1-5-17 Otemae, Chuo-ku, Osaka 540-0008, Japan. Electronic address: maeda-t@cc.osaka-dent.ac.jp.'}, {'ForeName': 'Kenichiro', 'Initials': 'K', 'LastName': 'Nakai', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Removable Prosthodontics and Occlusion, Osaka Dental University, 1-5-17 Otemae, Chuo-ku, Osaka 540-0008, Japan. Electronic address: nakai-ks@cc.osaka-dent.ac.jp.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Ichikawa', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Oral and Maxillofacial Prosthodontics, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima 770-8504, Japan. Electronic address: ichi@tokushima-u.ac.jp.'}, {'ForeName': 'Kan', 'Initials': 'K', 'LastName': 'Nagao', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Oral and Maxillofacial Prosthodontics, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima 770-8504, Japan. Electronic address: kan@tokushima-u.ac.jp.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Fujimoto', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Oral and Maxillofacial Prosthodontics, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima 770-8504, Japan. Electronic address: c301451014@tokushima-u.ac.jp.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Murata', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University, 1-7-1 Sakamoto, Nagasaki 852-8588, Japan. Electronic address: hmurata@nagasaki-u.ac.jp.'}, {'ForeName': 'Tadafumi', 'Initials': 'T', 'LastName': 'Kurogi', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University, 1-7-1 Sakamoto, Nagasaki 852-8588, Japan. Electronic address: kurofumi@nagasaki-u.ac.jp.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University, 1-7-1 Sakamoto, Nagasaki 852-8588, Japan. Electronic address: kyoshida@nagasaki-u.ac.jp.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Hosoi', 'Affiliation': 'The Japan Denture Care Society, Japan; Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa 230-8501, Japan. Electronic address: hosoi-t@tsurumi-u.ac.jp.'}, {'ForeName': 'Taizo', 'Initials': 'T', 'LastName': 'Hamada', 'Affiliation': 'The Japan Denture Care Society, Japan; Hiroshima University, 1-2-3 Kasumi, Minamiku, Hiroshima, Hiroshima 734-8553, Japan. Electronic address: thamada66@gmail.com.'}]",Journal of prosthodontic research,['10.1016/j.jpor.2019.08.004']
973,31494275,Therapy Habituation at 12 Months: Spinal Cord Stimulation Versus Dorsal Root Ganglion Stimulation for Complex Regional Pain Syndrome Type I and II.,"The ACCURATE randomized, controlled trial compared outcomes of dorsal root ganglion (DRG) stimulation versus tonic spinal cord stimulation (SCS) in 152 subjects with chronic lower extremity pain due to complex regional pain syndrome (CRPS) type I or II. This ACCURATE substudy was designed to evaluate whether therapy habituation occurs with DRG stimulation as compared to SCS through 12-months. A modified intention-to-treat analysis was performed to assess percentage pain relief (PPR) and responder rates at follow-up visits (end-of-trial, 1, 3, 6, 9, 12-months postpermanent implant) for all subjects that completed trial stimulation (DRG:N = 73, SCS:N = 72). For both groups, mean PPR was significantly greater at end-of-trial (DRG = 82.2%, SCS =0 77.0%) than all other follow-ups. Following permanent DRG system implantation, none of the time points were significantly different from one another in PPR (range = 69.3-73.9%). For the SCS group, PPR at 9-months (58.3%) and 12-months (57.9%) was significantly less than at 1-month (66.9%). The responder rate also decreased for the SCS group from 1-month (68.1%) to 12-months (61.1%). After stratifying by diagnosis, it was found that only the CRPS-I population had diminishing pain relief with SCS. DRG stimulation resulted in more stable pain relief through 12-months, while tonic SCS demonstrated therapy habituation at 9- and 12-months. Trial Registration: The ACCURATE study was registered at ClinicalTrials.gov with Identifier NCT01923285. PERSPECTIVE: This article reports on an ACCURATE substudy, which found that long-term therapy habituation occurred at 12-months with SCS, but not DRG stimulation, in patients with CRPS. The underlying mechanisms of action for these results remain unclear, although several lines of inquiry are proposed.",2020,"For the SCS group, PPR at 9-months (58.3%) and 12-months (57.9%) was significantly less than at 1-month (66.9%).","['152 subjects with chronic lower extremity pain due to complex regional pain syndrome (CRPS) type I or II', 'patients with CRPS']","['dorsal root ganglion (DRG) stimulation versus tonic spinal cord stimulation (SCS', 'DRG stimulation', 'Spinal Cord Stimulation Versus Dorsal Root Ganglion Stimulation']","['percentage pain relief (PPR) and responder rates', 'Complex Regional Pain', 'therapy habituation', 'mean PPR', 'responder rate', 'stable pain relief', 'pain relief with SCS']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0034931', 'cui_str': 'CRPS Type I'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0017070', 'cui_str': 'Dorsal Root Ganglia'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0394477', 'cui_str': 'Spinal Cord Stimulation'}, {'cui': 'C0011928', 'cui_str': 'DRG'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013170', 'cui_str': 'Drug habituation (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}]",152.0,0.0632925,"For the SCS group, PPR at 9-months (58.3%) and 12-months (57.9%) was significantly less than at 1-month (66.9%).","[{'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Levy', 'Affiliation': 'Marcus Neuroscience Institute, Boca Raton, Florida.'}, {'ForeName': 'Nagy', 'Initials': 'N', 'LastName': 'Mekhail', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kramer', 'Affiliation': 'Volta Research and University of Illinois College of Medicine, Chicago, Illinois.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Poree', 'Affiliation': 'University of California at San Francisco, California.'}, {'ForeName': 'Kasra', 'Initials': 'K', 'LastName': 'Amirdelfan', 'Affiliation': 'IPM Medical Group, Inc., Walnut Creek, California.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Grigsby', 'Affiliation': 'Neurovations, Napa, California.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Staats', 'Affiliation': 'Premier Pain Center, Shrewsbury Township, New Jersey.'}, {'ForeName': 'Allen W', 'Initials': 'AW', 'LastName': 'Burton', 'Affiliation': 'Abbott Neuromodulation, Plano, Texas.'}, {'ForeName': 'Abram H', 'Initials': 'AH', 'LastName': 'Burgher', 'Affiliation': 'HOPE Research - TPC, Phoenix, Arizona.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Scowcroft', 'Affiliation': 'Pain Management Associates, Independence, Missouri.'}, {'ForeName': 'Stan', 'Initials': 'S', 'LastName': 'Golovac', 'Affiliation': 'Florida Pain, Merritt Island, Florida.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Kapural', 'Affiliation': 'Carolinas Pain Institute, Winston-Salem, North Carolina.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Paicius', 'Affiliation': 'Newport Beach Headache and Pain, Newport Beach, California.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Pope', 'Affiliation': 'Evolve Restorative Center, Santa Rosa, California.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Samuel', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'William Porter', 'Initials': 'WP', 'LastName': 'McRoberts', 'Affiliation': 'Holy Cross Hospital, Ft. Lauderdale, Florida.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schaufele', 'Affiliation': 'Drug Studies America, Marietta, Georgia.'}, {'ForeName': 'Alexander R', 'Initials': 'AR', 'LastName': 'Kent', 'Affiliation': 'Abbott Neuromodulation, Plano, Texas. Electronic address: alex.kent@abbott.com.'}, {'ForeName': 'Adil', 'Initials': 'A', 'LastName': 'Raza', 'Affiliation': 'Abbott Neuromodulation, Plano, Texas.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Deer', 'Affiliation': 'Spine and Nerve Center of the Virginias, Charleston, West Virginia.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.08.005']
974,31602689,Reducing the Biological and Psychological Toxicity of Poverty-related Stress: Initial Efficacy of the BaSICS Intervention for Early Adolescents.,"This proof-of-concept study tests the initial efficacy of the Building a Strong Identity and Coping Skills (BaSICS) intervention, a selective prevention of internalizing problems program for early adolescents exposed to high levels of poverty-related stress. Eighty-four early adolescents (M age   = 11.36 years) residing in very low-income neighborhoods were randomized to receive the 16-session intervention (n = 44) or to an assessment-only control condition (n = 40). BaSICS teaches coping skills, social identity development, and collective social action to empower youth with the ability to connect with members of their communities and cope with poverty-related stress in positive and collaborative ways. Pretest-posttest analyses showed that intervention adolescents acquired problem-solving and cognitive-restructuring skills and reduced their reliance on avoidant coping. In addition, HPA reactivity was significantly reduced in the intervention youth, but not controls. Finally, intervention youth's internalizing and somatic symptoms as reported by both youth and their parents, showed significant reductions over time, whereas control youth had no such changes. Results provide strong support for this approach to strength-building and symptom reduction in a population of early adolescents exposed to poverty-related stress.",2020,Pretest-posttest analyses showed that intervention adolescents acquired problem-solving and cognitive-restructuring skills and reduced their reliance on avoidant coping.,"['Early Adolescents', '11.36\xa0years) residing in very low-income neighborhoods', 'early adolescents exposed to high levels of poverty-related stress', 'Eighty-four early adolescents (M age  \xa0']","['Building a Strong Identity and Coping Skills (BaSICS) intervention', '16-session intervention (n\xa0=\xa044) or to an assessment-only control condition', 'BaSICS Intervention']","['HPA reactivity', 'problem-solving and cognitive-restructuring skills and reduced their reliance on avoidant coping']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032854', 'cui_str': 'Poverty'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4319623', 'cui_str': '84 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0966198', 'cui_str': ""P(1)-(6-hydroxymethylpterin)-P(4)-(5'-adenosyl)tetraphosphate""}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0150173', 'cui_str': 'Cognitive restructuring (regime/therapy)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",84.0,0.0212825,Pretest-posttest analyses showed that intervention adolescents acquired problem-solving and cognitive-restructuring skills and reduced their reliance on avoidant coping.,"[{'ForeName': 'Martha E', 'Initials': 'ME', 'LastName': 'Wadsworth', 'Affiliation': 'The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Celina M', 'Initials': 'CM', 'LastName': 'Joos', 'Affiliation': 'The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Jarl A', 'Initials': 'JA', 'LastName': 'Ahlkvist', 'Affiliation': 'The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Sarah E D', 'Initials': 'SED', 'LastName': 'Perzow', 'Affiliation': 'University of Denver, Denver, CO, USA.'}, {'ForeName': 'Emile M', 'Initials': 'EM', 'LastName': 'Tilghman-Osborne', 'Affiliation': 'The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Creavey', 'Affiliation': 'The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Gina M', 'Initials': 'GM', 'LastName': 'Brelsford', 'Affiliation': 'Penn State University Harrisburg, Middletown, PA, USA.'}]",American journal of community psychology,['10.1002/ajcp.12400']
975,31490257,"Intravenous Lidocaine for the Prevention of Postoperative Catheter-Related Bladder Discomfort in Male Patients Undergoing Transurethral Resection of Bladder Tumors: A Randomized, Double-Blind, Controlled Trial.","BACKGROUND


Male patients undergoing transurethral resection of bladder tumors (TURBT) are prone to suffer from catheter-related bladder discomfort (CRBD). Lidocaine administration has been widely performed to reduce postoperative pain. Here, the effect of intravenous lidocaine administration on moderate-to-severe CRBD was evaluated in male patients undergoing TURBT.
METHODS


Patients were randomly allocated to receive intravenous lidocaine (1.5 mg/kg bolus dose followed by a 2 mg/kg/h continuous infusion during the intraoperative period, which was continued for 1 hour postsurgery; group L) or placebo (normal saline; group C). The primary outcome was moderate-to-severe CRBD at 0 hour postsurgery (on admission to the postanesthetic care unit), analyzed using the χ test. The secondary outcome was opioid requirement during the 24-hour postoperative period. None, mild, and moderate-to-severe CRBD at 1, 2, and 6 hours postsurgery, postoperative pain, patient satisfaction, side effects of lidocaine and rescue medications (tramadol and fentanyl), and surgical complications were also assessed.
RESULTS


A total of 132 patients were included in the study (66 patients in each group). The incidence of moderate-to-severe CRBD at 0 hour postsurgery was significantly lower in group L than in group C (25.8% vs 66.7%, P < .001, relative risk: 0.386, 95% confidence interval: 0.248-0.602). Opioid requirements during the 24-hour postoperative period were significantly lower in group L than in group C (10.0 mg [interquartile range (IQR), 5.0-15.0 mg] vs 13.8 mg [IQR, 10.0-20.0 mg], P = .005). At 1 and 2 hours postsurgery (but not at 6 hours), the incidence of moderate-to-severe CRBD was significantly lower in group L than in group C (1 hour: 10.6% vs 27.3%, P = .026; 2 hours: 0.0% vs 15.2%, P = .003). Patient satisfaction was significantly greater in group L than in group C (5.0 [IQR, 4.8-6.0] vs 4.0 [IQR, 4.0-5.0], P < .001). No lidocaine-related side effects were reported. Rescue medication-related side effects and surgical complications did not differ significantly between the 2 groups.
CONCLUSIONS


Intravenous lidocaine administration resulted in lower incidence of moderate-to-severe CRBD, lower opioid requirement, and higher patient satisfaction in male patients undergoing TURBT without evidence of significant side effects.",2020,"Patient satisfaction was signi&filig;cantly greater in group L than in group C (5.0 [IQR, 4.8-6.0] vs 4.0 [IQR, 4.0-5.0], P < .001).","['Patients', 'male patients undergoing TURBT', 'Male Patients Undergoing Transurethral Resection of Bladder Tumors', '132 patients were included in the study (66 patients in each group', 'male patients undergoing', 'Male patients undergoing']","['lidocaine', 'transurethral resection of bladder tumors (TURBT', 'placebo (normal saline', 'TURBT', 'intravenous lidocaine', 'Lidocaine', 'Intravenous Lidocaine']","['postoperative pain', 'postoperative pain, patient satisfaction, side effects of lidocaine and rescue medications (tramadol and fentanyl), and surgical complications', 'side effects', 'incidence of moderate-to-severe CRBD', 'Patient satisfaction', 'moderate-to-severe CRBD', 'Opioid requirements', 'opioid requirement during the 24-hour postoperative period', 'Rescue medication-related side effects and surgical complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",132.0,0.45349,"Patient satisfaction was signi&filig;cantly greater in group L than in group C (5.0 [IQR, 4.8-6.0] vs 4.0 [IQR, 4.0-5.0], P < .001).","[{'ForeName': 'Doo-Hwan', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jun-Young', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jihion', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang-A', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sooin', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jai-Hyun', 'Initials': 'JH', 'LastName': 'Hwang', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Gi-Ho', 'Initials': 'GH', 'LastName': 'Koh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chosun University Hospital, Gwangju, Republic of Korea.'}, {'ForeName': 'Young-Kug', 'Initials': 'YK', 'LastName': 'Kim', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004405']
976,31416011,"A randomized controlled dose-escalation study of SSS07, a humanized rabbit anti-human TNF alpha antibody, in healthy Chinese adults.","AIMS


SSS07 is a rabbit derived humanized anti-human TNF-α antibody. This study aimed to explore the pharmacokinetics, safety, and immunogenicity of SSS07 when administrated subcutaneously in healthy adults.
METHODS


This was a double-blind, dose-escalation study of SSS07 in 71 adults. Dose cohorts were set to 5 mg, 15 mg, 30 mg, 50 mg, 75 mg, and 100 mg. In each dosage group, other than 100 mg, twelve healthy participants were randomly assigned to receive a single dose of SSS07 (n = 10) or placebo (n = 2). Blood samples were taken for pharmacokinetics and immunogenicity analysis.
RESULTS


No deaths, serious adverse events or drug-related withdrawals occurred in this trial. No drug limited toxicity appeared. After subcutaneous injection, SSS07 was absorbed slowly with T max  ranging from 60 to 264 h but eliminated quickly with a short half-life ranging from 21.69 to 78.4 h (1-3 days). From 5 mg to 100 mg, dose-exposure proportionality analysis found a 90% confidence interval (CI) of β of C max  (1.015-1.193), AUC 0-t  (1.096-1.263) and AUC 0-∞  (0.999-1.174) partially within the range 0.926-1.074. The plasma concentration of TNF-α decreased significantly post-dose, but a few days later, levels of TNF-α elevated rapidly and exceeded its baseline value. All participants receiving SSS07 were found to be anti-drug antibody positive during the study.
CONCLUSIONS


A single-dose injection of SSS07 was safe and well-tolerated in healthy adults. Doses of SSS07 from 5 mg to 100 mg could not be regarded as nonlinear, based on dose-exposure proportionality analysis. A high incidence of anti-drug antibodies indicated strong immunogenicity, which may influence the pharmacokinetics profile and interfere with the TNF-α inhibition capability of SSS07.",2019,"The plasma concentration of TNF-α decreased significantly post-dose, but a few days later, levels of TNF-α elevated rapidly and exceeded its baseline value.","['twelve healthy participants', 'healthy adults', '71 adults', 'healthy Chinese adults']","['SSS07', 'placebo', 'humanized rabbit anti-human TNF alpha antibody']","['pharmacokinetics, safety, and immunogenicity', 'plasma concentration of TNF-α', 'No deaths, serious adverse events']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3887509', 'cui_str': 'Rabbits'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",71.0,0.107146,"The plasma concentration of TNF-α decreased significantly post-dose, but a few days later, levels of TNF-α elevated rapidly and exceeded its baseline value.","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Pharmacy, Peking University People's Hospital, Beijing, China; Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Beijing, China.""}, {'ForeName': 'Xinyao', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'United-Power Pharma Tech Co., Ltd., Beijing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Su', 'Affiliation': ""Department of Pharmacy, Peking University People's Hospital, Beijing, China; Xuzhou Medical University, Xuzhou, China.""}, {'ForeName': 'Jiaxue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Pharmacy, Peking University People's Hospital, Beijing, China; Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Beijing, China.""}, {'ForeName': 'Shi', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ""Department of Rheumatology and Immunology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Pharmacy, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Daoli', 'Initials': 'D', 'LastName': 'Jiang', 'Affiliation': 'Department of Pharmacy, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Yitong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Aix-Marseille University, 27 bd Jean Moulin, 13385 Marseille Cedex 05, France.'}, {'ForeName': 'Tan', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': ""Department of Pharmacy, Peking University People's Hospital, Beijing, China; Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Beijing, China.""}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""The Sixth Affiliated Hospital of Guangzhou Medical University, Qingyuan People's Hospital, Qingyuan, China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'United-Power Pharma Tech Co., Ltd., Beijing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Tao', 'Affiliation': 'Shenyang Sunshine Pharmaceutical Co., Ltd, Shenyang, China.'}, {'ForeName': 'Quanrui', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Shenyang Sunshine Pharmaceutical Co., Ltd, Shenyang, China.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Xi', 'Affiliation': 'United-Power Pharma Tech Co., Ltd., Beijing, China.'}, {'ForeName': 'Zhanguo', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Rheumatology and Immunology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': 'Department of Pharmacology and Toxicology, Beijing Institute of Radiation Medicine, Beijing, China. Electronic address: songhf@nic.bmi.ac.cn.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': ""Department of Pharmacy, Peking University People's Hospital, Beijing, China. Electronic address: phaseistudy@163.com.""}]",International immunopharmacology,['10.1016/j.intimp.2019.105807']
977,31448867,Procedural and clinical performance of dual- versus single-catheter strategy for transradial coronary angiography: A meta-analysis of randomized trials.,"OBJECTIVES


We sought to compare the procedural and clinical performance of dual- versus single-catheter strategy for transradial coronary angiography.
BACKGROUND


The radial artery (RA) is recommended as the vascular access of choice in patients undergoing coronary angiography and intervention. The procedural and clinical performance of dual- versus single-catheter strategy in patients undergoing transradial coronary angiography remains a matter of debate.
METHODS


This is a study-level meta-analysis of randomized trials. The primary outcome was procedure time. The main secondary outcome was fluoroscopy time. Other outcomes of interest were contrast volume, crossover to other catheter strategy and RA spasm.
RESULTS


A total of 2,062 patients (978 randomly assigned to dual-catheter and 1,084 to single-catheter strategy) included in seven trials were available for the quantitative synthesis. A dual-catheter strategy was associated with procedure time (standardized mean difference [95% confidence intervals (CI)], 0.55 [-0.69, 1.78]; p = .32), fluoroscopy time (-0.36 [-2.39, 1.67]; p = .68) and contrast volume (-0.93 [-3.79, 1.94]; p = .44) comparable to a single-catheter strategy. The risk for crossover was lower (risk ratio [95% CI], 0.14 [0.03, 0.70]; p = .025) while the risk for RA spasm was higher (1.81 [1.54, 2.12]; p < .001) among patients assigned to dual- versus single-catheter strategy.
CONCLUSIONS


This meta-analysis provides evidence for a comparable procedural performance of either dual- or single-catheter strategy for transradial coronary angiography. The fewer crossovers with dual-catheter strategy occur at the expense of more frequent radial artery spasm.",2020,"p = .025) while the risk for RA spasm was higher (1.81 [1.54, 2.12];","['2,062 patients (978 randomly assigned to', 'patients undergoing transradial coronary angiography remains a matter of debate', 'patients undergoing coronary angiography and intervention']","['dual- versus single-catheter strategy', 'dual-catheter and 1,084 to single-catheter strategy', 'transradial coronary angiography']","['risk for RA spasm', 'procedure time', 'fluoroscopy time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0037763', 'cui_str': 'Muscular Spasm'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}]",2062.0,0.304113,"p = .025) while the risk for RA spasm was higher (1.81 [1.54, 2.12];","[{'ForeName': 'Brunilda', 'Initials': 'B', 'LastName': 'Alushi', 'Affiliation': 'Department of Cardiology, University Heart Center Berlin and Charite University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Lauten', 'Affiliation': 'Department of Cardiology, University Heart Center Berlin and Charite University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Gjin', 'Initials': 'G', 'LastName': 'Ndrepepa', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Leistner', 'Affiliation': 'Department of Cardiology, University Heart Center Berlin and Charite University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Kufner', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Erion', 'Initials': 'E', 'LastName': 'Xhepa', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Landmesser', 'Affiliation': 'Department of Cardiology, University Heart Center Berlin and Charite University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Cassese', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28458']
978,31859197,Comparison of intradermal mesotherapy with systemic therapy in the treatment of low back pain: A prospective randomized study.,"INTRODUCTION


Musculoskeletal pain such as low back pain (LBP) are routinely encountered in the ED and contribute to ED overcrowding. The aim of our study was to compare the efficiency of mesotherapy with systemic therapy in pain control in patients with lumbar disk herniation.
METHODS


We conducted this prospective parallel randomized controlled trial with the patients admitted to the emergency department with low back pain related to herniated lumbar disk. Mesotherapy was performed to one group, while intravenous dexketoprofen was administered to the control group. Changes in pain intensity at 15th minute, 30th minute, 60th minute and 24th hours after treatment using Visual Analogue Scale (VAS), need to use analgesic drug within 24 h after treatment, and adverse effect of the treatment methods were compared between groups.
RESULTS


The decreases in pain intensity were statistically significantly higher in mesotherapy group for all time intervals. The need to use analgesics was statistically significantly three fold higher in the systemic therapy group. There was no statistically significant difference in having any adverse effect between study groups during one-week follow-up period.
CONCLUSIONS


Changes in medical practices, from the systemic administration of NSAIDs to the minimally invasive techniques such as mesotherapy with potent efficacy and minimal side effects, may enhance the ability of EDs to meet the waiting time targets and improve patient's satisfaction.",2020,The need to use analgesics was statistically significantly three fold higher in the systemic therapy group.,"['low back pain', 'patients with lumbar disk herniation', 'patients admitted to the emergency department with low back pain related to herniated lumbar disk']","['intradermal mesotherapy with systemic therapy', 'mesotherapy with systemic therapy', 'dexketoprofen', 'Mesotherapy']","['Visual Analogue Scale (VAS), need to use analgesic drug', 'pain intensity', 'adverse effect']","[{'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]","[{'cui': 'C2242515', 'cui_str': 'Mesotherapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0772505', 'cui_str': 'Dexketoprofen'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0708111,The need to use analgesics was statistically significantly three fold higher in the systemic therapy group.,"[{'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Akbas', 'Affiliation': 'Department of Emergency Medicine, Bingöl State Hospital, Bingöl, Turkey. Electronic address: akbasilker@gmail.com.'}, {'ForeName': 'Abdullah Osman', 'Initials': 'AO', 'LastName': 'Kocak', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Meryem Betos', 'Initials': 'MB', 'LastName': 'Kocak', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Cakir', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.11.044']
979,31924513,Incidence and Management of Diarrhea With Adjuvant Pertuzumab and Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer.,"BACKGROUND


The APHINITY (BIG 4-11) study showed that pertuzumab significantly improved the rates of invasive disease-free survival among patients with human epidermal growth factor receptor 2 (HER2)-positive, operable breast cancer when added to adjuvant trastuzumab and chemotherapy. Because diarrhea was a common adverse event that could compromise treatment administration, we evaluated the incidence and management of diarrhea in the APHINITY study.
PATIENTS AND METHODS


The APHINITY trial is a prospective, randomized, multicenter, multinational, double-blind, placebo-controlled trial. The eligible patients were randomly assigned to receive standard adjuvant chemotherapy and 1 year of trastuzumab combined with pertuzumab or placebo. The diarrhea incidence, severity (National Cancer Institute common terminology criteria for adverse events, version 4.0), onset, and management were analyzed.
RESULTS


A total of 4805 patients were randomized. Diarrhea of any grade was the most common adverse event and occurred in 71% of patients in the pertuzumab arm versus 45% in the placebo arm. Diarrhea grade 3 to 4 was observed in 10% and 4% in the pertuzumab and placebo arms, respectively. The greatest incidence of diarrhea was reported during the concomitant administration of HER2-targeted therapy and taxane (61% vs. 34% of patients experienced an event with pertuzumab vs. placebo, respectively). A marked decrease was observed on chemotherapy cessation. Antidiarrheal agents were commonly used, and diarrhea rarely caused treatment dose modifications or discontinuation.
CONCLUSION


Diarrhea was a common adverse event in the APHINITY study. Most episodes were low grade and were generally manageable with common antidiarrheal agents. The incidence of diarrhea was greater with the combination of a taxane and HER2-targeted treatment and decreased once chemotherapy was stopped.",2020,Diarrhea of any grade was the most common adverse event and occurred in 71% of patients in the pertuzumab arm versus 45% in the placebo arm.,"['4805 patients were randomized', 'patients with human epidermal growth factor receptor 2 (HER2)-positive, operable breast cancer', 'Patients With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer']","['standard adjuvant chemotherapy and 1 year of trastuzumab combined with pertuzumab or placebo', 'placebo', 'HER2-targeted therapy and taxane', 'taxane and HER2-targeted', 'pertuzumab', 'Pertuzumab and Trastuzumab', 'trastuzumab and chemotherapy']","['chemotherapy cessation', 'Diarrhea grade 3 to 4', 'incidence of diarrhea', 'diarrhea', 'diarrhea incidence, severity (National Cancer Institute', 'Incidence and Management of Diarrhea', 'rates of invasive disease-free survival', 'Diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205188', 'cui_str': 'Operable (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",4805.0,0.285091,Diarrhea of any grade was the most common adverse event and occurred in 71% of patients in the pertuzumab arm versus 45% in the placebo arm.,"[{'ForeName': 'José', 'Initials': 'J', 'LastName': 'Bines', 'Affiliation': 'Instituto Nacional de Câncer and Clínica São Vicente, Rio de Janeiro, Brazil. Electronic address: jose_bines@yahoo.com.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Procter', 'Affiliation': 'Frontier Science, Kincraig, United Kingdom.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Restuccia', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Viale', 'Affiliation': 'University of Milan and European Institute of Oncology, Scientific Institute for Research, Hospitalization, and Healthcare, Milan, Italy.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Zardavas', 'Affiliation': 'The Breast International Group, Brussels, Belgium; Bristol-Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Suter', 'Affiliation': 'Roche Pharma, Bern, Switzerland.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Arahmani', 'Affiliation': 'The Breast International Group, Brussels, Belgium.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Van Dooren', 'Affiliation': 'Breast European Adjuvant Study Team Data Center, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Baselga', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Clark', 'Affiliation': 'Roche Products, Welwyn Garden City, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Eng-Wong', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA; Harvard Medical School, Boston, MA; Harvard T.H. Chan School of Public Health, Boston, MA; Frontier Science and Technology Research Foundation, Boston, MA.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Piccart', 'Affiliation': 'Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Mobus', 'Affiliation': 'Clinical Center Frankfurt Höchst, Frankfurt, Germany.'}, {'ForeName': 'Evandro', 'Initials': 'E', 'LastName': 'de Azambuja', 'Affiliation': 'Breast European Adjuvant Study Team Data Center, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical breast cancer,['10.1016/j.clbc.2019.06.016']
980,31362969,Short-term weight gain among preschool children in rural Burkina Faso: a secondary analysis of a randomised controlled trial.,"OBJECTIVES


Nutrition has profound effects on children's health outcomes and is linked to weight gain and cognitive development. We used data from a randomised controlled trial to evaluate the prospective associations between dietary, socioeconomic and demographic factors and short-term weight gain during the lean season in a rural area of Burkina Faso.
DESIGN


Prospective cohort data arising from a randomised controlled trial of the effect of antibiotic distribution on child growth and intestinal microbial diversity.
SETTING


Two rural communities in Nouna District, Burkina Faso.
PARTICIPANTS


246 children aged 6-59 months living in the study communities were enrolled in the study.
PRIMARY AND SECONDARY OUTCOME MEASURES


Anthropometric measurements, including weight and height, were obtained at baseline and 1 month.
RESULTS


Of 246 children, the median weight for wasted children at baseline (weight-for-height z-score <-2) was 9.7 kg (IQR 8.65-10.8) and the weight of non-wasted children was 12.8 kg (IQR 10.9-14.75). Food insecurity was significantly associated with decreased weight gain velocity (mean difference -0.03 g/kg/day, 95% CI -0.06 to -0.006, p=0.04).
CONCLUSION


Experiences of household food insecurity before the beginning of the lean season were associated with decreased weight gain in children in rural Burkina Faso during the lean season, although the mean difference was small. Understanding the relationship between timing of food insecurity and anthropometric outcomes may help to develop policies and health programme that address both of these issues.
TRIAL REGISTRATION NUMBER


NCT03187834.",2019,"Food insecurity was significantly associated with decreased weight gain velocity (mean difference -0.03 g/kg/day, 95% CI -0.06 to -0.006, p=0.04).
","['246 children aged 6-59 months living in the study communities were enrolled in the study', '246 children', 'preschool children in rural Burkina Faso', 'Two rural communities in Nouna District, Burkina Faso']","['antibiotic distribution', 'Short-term weight gain']","['weight gain velocity', 'weight and height', 'weight gain', 'median weight']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0006409', 'cui_str': 'Upper Volta'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",246.0,0.192416,"Food insecurity was significantly associated with decreased weight gain velocity (mean difference -0.03 g/kg/day, 95% CI -0.06 to -0.006, p=0.04).
","[{'ForeName': 'Elena G', 'Initials': 'EG', 'LastName': 'Dennis', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, California, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sie', 'Affiliation': 'Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Lucienne', 'Initials': 'L', 'LastName': 'Ouermi', 'Affiliation': 'Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Dah', 'Affiliation': 'Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Charlemagne', 'Initials': 'C', 'LastName': 'Tapsoba', 'Affiliation': 'Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Zabre', 'Affiliation': 'Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Institute of Public Health, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Kieran S', 'Initials': 'KS', 'LastName': ""O'Brien"", 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, California, USA.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lebas', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, California, USA.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, California, USA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, California, USA catherine.oldenburg@ucsf.edu.'}]",BMJ open,['10.1136/bmjopen-2019-029634']
981,31707829,REDUCE-IT USA: Results From the 3146 Patients Randomized in the United States.,"BACKGROUND


Some trials have found that patients from the United States derive less benefit than patients enrolled outside the United States. This prespecified REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl - Intervention Trial) subgroup analysis was conducted to determine the degree of benefit of icosapent ethyl in the United States.
METHODS


REDUCE-IT randomized 8179 statin-treated patients with qualifying triglycerides ≥135 and <500 mg/dL and low-density lipoprotein cholesterol >40 and ≤100 mg/dL and a history of atherosclerosis or diabetes mellitus to icosapent ethyl 4 g/d or placebo. The primary composite end point was cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or hospitalization for unstable angina. The key secondary composite end point was cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. A hierarchy was prespecified for examination of individual and composite end points.
RESULTS


A total of 3146 US patients (38.5% of the trial) were randomized and followed for a median of 4.9 years; 32.3% were women and 9.7% were Hispanic. The primary composite end point occurred in 24.7% of placebo-treated patients versus 18.2% of icosapent ethyl-treated patients (hazard ratio [HR], 0.69 [95% CI, 0.59-0.80];  P =0.000001); the key secondary composite end point occurred in 16.6% versus 12.1% (HR, 0.69 [95% CI, 0.57-0.83];  P =0.00008). All prespecified hierarchical end points were meaningfully and significantly reduced, including cardiovascular death (6.7% to 4.7%; HR, 0.66 [95% CI, 0.49-0.90];  P =0.007), myocardial infarction (8.8% to 6.7%; HR, 0.72 [95% CI, 0.56-0.93];  P =0.01), stroke (4.1% to 2.6%; HR, 0.63 [95% CI, 0.43-0.93];  P =0.02), and all-cause mortality (9.8% to 7.2%; HR, 0.70 [95% CI, 0.55-0.90];  P =0.004); for all-cause mortality in the US versus non-US patients,  P interaction =0.02. Safety and tolerability findings were consistent with the full study cohort.
CONCLUSIONS


Whereas the non-US subgroup showed significant reductions in the primary and key secondary end points, the US subgroup demonstrated particularly robust risk reductions across a variety of individual and composite end points, including all-cause mortality.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT01492361.",2020,"All prespecified hierarchy endpoints were meaningfully and significantly reduced, including cardiovascular death (6.7% to 4.7%, HR 0.66, 95% CI 0.49-0.90, p=0.007), myocardial infarction (8.8% to 6.7%, HR 0.72, 95% CI 0.56-0.93, p=0.01), stroke (4.1% to 2.6%, HR 0.63, 95% CI 0.43-0.93, p=0.02), and all-cause mortality (9.8% to 7.2%, HR 0.70, 95% CI 0.55-0.90, p=0.004); for all-cause mortality for the USA versus non-USA patients, p interaction =0.02.","['3,146 Patients Randomized in the United States', '8,179 statin-treated patients with qualifying triglycerides ≥135 and <500 mg/dL and low-density lipoprotein (LDL)-cholesterol >40 and ≤100 mg/dL and a history of atherosclerosis or diabetes to icosapent ethyl 4 grams/day or', '3,146 USA patients (38.5% of the trial) were randomized and followed for a median of 4.9 years; 32.3% were women, 9.7% Hispanic']",['placebo'],"['stroke', 'cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke', 'cause mortality', 'myocardial infarction', 'cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, or hospitalization for unstable angina', 'Safety and tolerability', 'cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0058978', 'cui_str': 'icosapent ethyl'}, {'cui': 'C0439417', 'cui_str': 'g/day'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",3146.0,0.454731,"All prespecified hierarchy endpoints were meaningfully and significantly reduced, including cardiovascular death (6.7% to 4.7%, HR 0.66, 95% CI 0.49-0.90, p=0.007), myocardial infarction (8.8% to 6.7%, HR 0.72, 95% CI 0.56-0.93, p=0.01), stroke (4.1% to 2.6%, HR 0.63, 95% CI 0.43-0.93, p=0.02), and all-cause mortality (9.8% to 7.2%, HR 0.70, 95% CI 0.55-0.90, p=0.004); for all-cause mortality for the USA versus non-USA patients, p interaction =0.02.","[{'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA (D.L.B.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'Department of Medicine, University of Maryland School of Medicine, Baltimore (M.M.).'}, {'ForeName': 'Eliot A', 'Initials': 'EA', 'LastName': 'Brinton', 'Affiliation': 'Utah Lipid Center, Salt Lake City (E.A.B.).'}, {'ForeName': 'Terry A', 'Initials': 'TA', 'LastName': 'Jacobson', 'Affiliation': 'Lipid Clinic and Cardiovascular Risk Reduction Program, Department of Medicine, Emory University School of Medicine, Atlanta, GA (T.A.J.).'}, {'ForeName': 'Ph Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'French Alliance for Cardiovascular Trials, Hôpital Bichat, Paris, France (P.G.S.).'}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Ketchum', 'Affiliation': 'Amarin Pharma, Inc., Bridgewater, NJ (S.B.K., R.T.D., R.A.J., L.J., C.G.).'}, {'ForeName': 'Ralph T', 'Initials': 'RT', 'LastName': 'Doyle', 'Affiliation': 'Amarin Pharma, Inc., Bridgewater, NJ (S.B.K., R.T.D., R.A.J., L.J., C.G.).'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Juliano', 'Affiliation': 'Amarin Pharma, Inc., Bridgewater, NJ (S.B.K., R.T.D., R.A.J., L.J., C.G.).'}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Jiao', 'Affiliation': 'Amarin Pharma, Inc., Bridgewater, NJ (S.B.K., R.T.D., R.A.J., L.J., C.G.).'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Granowitz', 'Affiliation': 'Amarin Pharma, Inc., Bridgewater, NJ (S.B.K., R.T.D., R.A.J., L.J., C.G.).'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Tardif', 'Affiliation': 'Montreal Heart Institute, Université de Montréal, Quebec, Canada (J.-C.T.).'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Olshansky', 'Affiliation': 'University of Iowa, Iowa City (B.O.).'}, {'ForeName': 'Mina K', 'Initials': 'MK', 'LastName': 'Chung', 'Affiliation': 'Cleveland Clinic, OH (M.K.C.).'}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Beth Israel Deaconess Hospital, Boston, MA (C.M.G.).'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (R.P.G.).""}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Budoff', 'Affiliation': 'Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center, Torrance, CA (M.J.B.).'}, {'ForeName': 'Christie M', 'Initials': 'CM', 'LastName': 'Ballantyne', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, TX (C.M.B.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.044440']
982,31645430,Maternal Humoral Immune Responses Do Not Predict Postnatal HIV-1 Transmission Risk in Antiretroviral-Treated Mothers from the IMPAACT PROMISE Study.,"To design immune interventions that can synergize with antiretroviral therapy (ART) to reduce the rate of HIV mother-to-child transmission (MTCT), it is essential to characterize maternal immune responses in the setting of ART during pregnancy and breastfeeding and define their effect on MTCT. Prior studies reported an association between breast milk envelope (Env)-specific antibodies and antibody-dependent cell cytotoxicity (ADCC) activity with reduced postnatal transmission. In this study, we investigated whether these immune correlates were similarly associated with protection in a matched case-control study of mother-infant pairs receiving maternal ART or infant nevirapine prophylaxis during breastfeeding in the International Maternal-Pediatric-Adolescent AIDS Clinical Trials Network Promoting Maternal-Infant Survival Everywhere (PROMISE) trial, assessing postnatal transmission risk in 19 transmitting and 57 nontransmitting mothers using conditional logistic regression models adjusted for maternal plasma viral load. The odds ratios of postnatal MTCT for a 1-unit increase in an immune correlate were 3.61 (95% confidence interval [CI], 0.56, 23.14) for breast milk Env-specific secretory IgA (sIgA), 2.32 (95% CI, 0.43, 12.56) for breast milk and 2.16 (95% CI, 0.51, 9.14) for plasma Env-specific IgA, and 4.57 (95% CI, 0.68, 30.48) for breast milk and 0.96 (95% CI, 0.25, 3.67) for plasma ADCC activity, with all CIs spanning 1.0. Interestingly, although mucosal IgA responses are poor in untreated HIV-infected women, there was a strong correlation between the magnitudes of breast milk and plasma Env-specific IgA in this cohort. In this analysis of the small number of postnatal virus transmissions in the landmark PROMISE study, no single antibody response was associated with breast milk transmission risk. IMPORTANCE  Each year, >150,000 infants become newly infected with HIV-1 through MTCT despite ART, with up to 42% of infections occurring during breastfeeding. Several factors contribute to continued pediatric infections, including ART nonadherence, the emergence of drug-resistant HIV strains, acute infection during breastfeeding, and poor access to ART in resource-limited areas. A better understanding of the maternal humoral immune responses that provide protection against postnatal transmission in the setting of ART is critical to guide the design of maternal vaccine strategies to further eliminate postnatal HIV transmission. In this study, we found that in women treated with antiretrovirals during pregnancy, there was a positive correlation between plasma viral load and breast milk and plasma IgA responses; however, conclusions regarding odds of MTCT risk were limited by the small sample size. These findings will inform future studies to investigate maternal immune interventions that can synergize with ART to eliminate MTCT during breastfeeding.",2019,"The odds ratios of postnatal MTCT for a 1-unit increase in an immune correlate were 3.61 (95% confidence interval [CI], 0.56, 23.14) for breast milk Env-specific secretory IgA (sIgA), 2.32 (95% CI, 0.43, 12.56) for breast milk and 2.16 (95% CI, 0.51, 9.14) for plasma Env-specific IgA, and 4.57 (95% CI, 0.68, 30.48) for breast milk and 0.96 (95% CI, 0.25, 3.67) for plasma ADCC activity, with all CIs spanning 1.0.","['150,000 infants become newly infected with HIV-1 through MTCT despite ART, with up to 42% of infections occurring during breastfeeding', '19 transmitting and 57 nontransmitting mothers']","['mother-infant pairs receiving maternal ART or infant nevirapine prophylaxis', 'antiretroviral therapy (ART']","['Maternal Humoral Immune Responses', 'plasma ADCC activity', 'cell cytotoxicity (ADCC) activity', 'mucosal IgA responses', 'plasma viral load and breast milk and plasma IgA responses', 'Maternal-Infant Survival', 'Transmission Risk', 'odds ratios of postnatal MTCT']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0282474', 'cui_str': 'Infection Transmission, Maternal-Fetal'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0242781', 'cui_str': 'Communicable Disease Transmission'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0020967', 'cui_str': 'Humoral Immunity'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003272', 'cui_str': 'Antibody-dependent cellular cytotoxicity'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0282474', 'cui_str': 'Infection Transmission, Maternal-Fetal'}]",150000.0,0.125915,"The odds ratios of postnatal MTCT for a 1-unit increase in an immune correlate were 3.61 (95% confidence interval [CI], 0.56, 23.14) for breast milk Env-specific secretory IgA (sIgA), 2.32 (95% CI, 0.43, 12.56) for breast milk and 2.16 (95% CI, 0.51, 9.14) for plasma Env-specific IgA, and 4.57 (95% CI, 0.68, 30.48) for breast milk and 0.96 (95% CI, 0.25, 3.67) for plasma ADCC activity, with all CIs spanning 1.0.","[{'ForeName': 'Eliza D', 'Initials': 'ED', 'LastName': 'Hompe', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Denise L', 'Initials': 'DL', 'LastName': 'Jacobson', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Eudailey', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Butler', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Edwards', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Pollara', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Sean S', 'Initials': 'SS', 'LastName': 'Brummel', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Genevieve G', 'Initials': 'GG', 'LastName': 'Fouda', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Lameck', 'Initials': 'L', 'LastName': 'Chinula', 'Affiliation': 'University of North Carolina Project-Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'Kamanga', 'Affiliation': 'Johns Hopkins University Research Project, Blantyre, Malawi.'}, {'ForeName': 'Aarti', 'Initials': 'A', 'LastName': 'Kinikar', 'Affiliation': 'Byramjee Jeejeebhoy Government Medical College, Pune, Maharashtra, India.'}, {'ForeName': 'Dhayendre', 'Initials': 'D', 'LastName': 'Moodley', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa and School of Clinical Medicine, College of Health Sciences, University of KwaZulu Natal, Durban, South Africa.'}, {'ForeName': 'Maxensia', 'Initials': 'M', 'LastName': 'Owor', 'Affiliation': 'Johns Hopkins University Research Collaboration, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Sallie R', 'Initials': 'SR', 'LastName': 'Permar', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, USA sallie.permar@duke.edu.'}]",mSphere,['10.1128/mSphere.00716-19']
983,31469675,Mitomycin C-augmented Phacotrabeculectomy Versus Phacoemulsification in Primary Angle-closure Glaucoma: A Randomized Controlled Study.,"PRECIS


Phacotrabeculectomy yielded similar results to phacoemulsification in primary angle-closure glaucoma (PACG) in terms of intraocular pressure (IOP) lowering, glaucoma medications and success rates. Although releasable sutures may have reduced the risk of hypotony; complications and interventions were more common with phacotrabeculectomy.
PURPOSE


To compare the efficacy and safety of phacotrabeculectomy using releasable sutures and adjunctive mitomycin C versus phacoemulsification alone in the management of PACG.
PATIENTS AND METHODS


In total, 63 eyes of 63 PACG patients were randomized to undergo either mitomycin C-augmented phacotrabeculectomy with tight scleral flap closure using releasable sutures aiming at no flow or phacoemulsification alone. The primary outcomes were success rates and complications. Secondary outcomes were IOP and glaucoma medications.
RESULTS


The IOP and glaucoma medications were significantly reduced at 1, 3, 6, and 12 months postoperatively in both groups (P<0.001). There was no statistically significant difference in IOP, IOP reduction, success rates, or survival times between both groups. Glaucoma medications were only significantly lower in the phacotrabeculectomy group at 1 and 3 months. The rates of postoperative interventions and complications were higher in the phacotrabeculectomy group. Complete success, defined as an IOP of 6 to 21 mm Hg on no medications and with no signs of glaucoma progression, was achieved in 58% in the phacotrabeculectomy group, compared with 62% in the phacoemulsification group (P=0.9). Only 2 eyes (6%) in the phacoemulsification group required a subsequent trabeculectomy.
CONCLUSIONS


Trabeculectomy did not seem to add an advantage when combined with phacoemulsification in PACG patients and was associated with more postoperative interventions. Despite the use of releasable sutures to allow titration of the IOP postoperatively, the rate of hypotony and other complications was higher in the phacotrabeculectomy group.",2019,"PRECIS


Phacotrabeculectomy yielded similar results to phacoemulsification in primary angle-closure glaucoma (PACG) in terms of intraocular pressure (IOP) lowering, glaucoma medications and success rates.","['Primary Angle-closure Glaucoma', 'In total, 63 eyes of 63 PACG patients']","['phacotrabeculectomy using releasable sutures and adjunctive mitomycin C versus phacoemulsification alone', 'Mitomycin C-augmented Phacotrabeculectomy Versus Phacoemulsification', 'mitomycin C-augmented phacotrabeculectomy with tight scleral flap closure using releasable sutures aiming at no flow or phacoemulsification alone']","['rates of postoperative interventions and complications', 'Complete success', 'intraocular pressure (IOP) lowering, glaucoma medications and success rates', 'Glaucoma medications', 'rate of hypotony and other complications', 'success rates and complications', 'IOP, IOP reduction, success rates, or survival times', 'efficacy and safety', 'glaucoma progression', 'IOP and glaucoma medications']","[{'cui': 'C0017606', 'cui_str': 'Primary angle-closure glaucoma (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1167708', 'cui_str': 'Phacotrabeculectomy'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0453911', 'cui_str': 'Tights (physical object)'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",,0.14059,"PRECIS


Phacotrabeculectomy yielded similar results to phacoemulsification in primary angle-closure glaucoma (PACG) in terms of intraocular pressure (IOP) lowering, glaucoma medications and success rates.","[{'ForeName': 'Yasmine M', 'Initials': 'YM', 'LastName': 'El Sayed', 'Affiliation': 'Department of Ophthalmology, Kasr Al-Ainy School of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Abdelrahman M', 'Initials': 'AM', 'LastName': 'Elhusseiny', 'Affiliation': ''}, {'ForeName': 'Ahmed S', 'Initials': 'AS', 'LastName': 'Albalkini', 'Affiliation': ''}, {'ForeName': 'Reem H', 'Initials': 'RH', 'LastName': 'El Sheikh', 'Affiliation': ''}, {'ForeName': 'Mona A', 'Initials': 'MA', 'LastName': 'Osman', 'Affiliation': ''}]",Journal of glaucoma,['10.1097/IJG.0000000000001345']
984,32000753,Effect of air-polishing on surface roughness of composite dental restorative material - comparison of three different air-polishing powders.,"BACKGROUND


Increased composite roughness enhances bacterial adhesion and discoloration, thus increasing the risk of gingival inflammation and secondary caries. Concerns about detrimental effects of sodium bicarbonate on surface roughness influenced the development of less abrasive powders: a glycine-based powder and an erythritol-based powder, additionally - sodium bicarbonate-based powder of reduced grain size. However, there is limited evidence on effects of these materials on the surface of dental fillings. The aim of the present study was to compare the effects of three air-polishing powders (of a reduced abrasiveness) on surface roughness of microhybrid restorative composite material.
MATERIAL AND METHODS


Microhybrid light-cure resin composite samples were placed on 64 plaster cubes and light-cured through polyester strips. Surface roughness was measured using laser confocal microscope (magnification 2160x). The specimens were randomly divided into three groups (n = 20, 20 and 24) and air-polished with: sodium bicarbonate (40 μm), glycine (25 μm) and erythritol (14 μm), respectively. Then surface roughness was remeasured, keeping the same field of observation. Specialized 3D analysis software was used for data processing. Parameters according to ISO 25178: Sa, Sq, Sku, Sp, Sv, Sz, Ssk were used to describe surface roughness.
RESULTS


Sa, Sq, Sp, Sv, Sz increased significantly following air polishing. Ssk was significantly higher, whereas Sku was significantly lower in sodium bicarbonate and erythritol groups than before air polishing. Comparison between the three powders revealed that Sa was significantly higher in sodium bicarbonate group than in glycine group. Sku was significantly higher in glycine and erythritol groups than in sodium bicarbonate group.
CONCLUSIONS


Sodium bicarbonate has a stronger detrimental effect on composite surface than glycine or erythritol. No advantage of erythritol comparing to glycine could be found.",2020,"Ssk was significantly higher, whereas Sku was significantly lower in sodium bicarbonate and erythritol groups than before air polishing.","['composite dental restorative material - comparison of three different air-polishing powders', 'Microhybrid light-cure resin composite samples were placed on 64 plaster cubes and light-cured through polyester strips']","['sodium bicarbonate', 'air-polishing', 'sodium bicarbonate (40\u2009μm), glycine', 'glycine', 'Sodium bicarbonate']","['Sa', 'Surface roughness', 'Sku']","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0182981', 'cui_str': 'Dental restorative material'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0460977', 'cui_str': 'Plasters (physical object)'}, {'cui': 'C0032474', 'cui_str': 'Polyesters'}, {'cui': 'C1321564', 'cui_str': 'Strip'}]","[{'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}]","[{'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}]",,0.0193658,"Ssk was significantly higher, whereas Sku was significantly lower in sodium bicarbonate and erythritol groups than before air polishing.","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Janiszewska-Olszowska', 'Affiliation': 'Department of Interdisciplinary Dentistry Pomeranian Medical, University in Szczecin, al. Powstancow Wlkp, 72, 70-111, Szczecin, Poland. jjo@pum.edu.pl.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Drozdzik', 'Affiliation': 'Department of Interdisciplinary Dentistry Pomeranian Medical, University in Szczecin, al. Powstancow Wlkp, 72, 70-111, Szczecin, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Tandecka', 'Affiliation': 'Faculty of Mechanical Engineering Koszalin, University of Technology, ul, Raclawicka 15-17, 75-620, Koszalin, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Grocholewicz', 'Affiliation': 'Department of Interdisciplinary Dentistry Pomeranian Medical, University in Szczecin, al. Powstancow Wlkp, 72, 70-111, Szczecin, Poland.'}]",BMC oral health,['10.1186/s12903-020-1007-y']
985,31472930,Planned early delivery or expectant management for late preterm pre-eclampsia (PHOENIX): a randomised controlled trial.,"BACKGROUND


In women with late preterm pre-eclampsia, the optimal time to initiate delivery is unclear because limitation of maternal disease progression needs to be balanced against infant complications. The aim of this trial was to determine whether planned earlier initiation of delivery reduces maternal adverse outcomes without substantial worsening of neonatal or infant outcomes, compared with expectant management (usual care) in women with late preterm pre-eclampsia.
METHODS


In this parallel-group, non-masked, multicentre, randomised controlled trial done in 46 maternity units across England and Wales, we compared planned delivery versus expectant management (usual care) with individual randomisation in women with late preterm pre-eclampsia from 34 to less than 37 weeks' gestation and a singleton or dichorionic diamniotic twin pregnancy. The co-primary maternal outcome was a composite of maternal morbidity or recorded systolic blood pressure of at least 160 mm Hg with a superiority hypothesis. The co-primary perinatal outcome was a composite of perinatal deaths or neonatal unit admission up to infant hospital discharge with a non-inferiority hypothesis (non-inferiority margin of 10% difference in incidence). Analyses were by intention to treat, together with a per-protocol analysis for the perinatal outcome. The trial was prospectively registered with the ISRCTN registry, ISRCTN01879376. The trial is closed to recruitment but follow-up is ongoing.
FINDINGS


Between Sept 29, 2014, and Dec 10, 2018, 901 women were recruited. 450 women (448 women and 471 infants analysed) were allocated to planned delivery and 451 women (451 women and 475 infants analysed) to expectant management. The incidence of the co-primary maternal outcome was significantly lower in the planned delivery group (289 [65%] women) compared with the expectant management group (338 [75%] women; adjusted relative risk 0·86, 95% CI 0·79-0·94; p=0·0005). The incidence of the co-primary perinatal outcome by intention to treat was significantly higher in the planned delivery group (196 [42%] infants) compared with the expectant management group (159 [34%] infants; 1·26, 1·08-1·47; p=0·0034). The results from the per-protocol analysis were similar. There were nine serious adverse events in the planned delivery group and 12 in the expectant management group.
INTERPRETATION


There is strong evidence to suggest that planned delivery reduces maternal morbidity and severe hypertension compared with expectant management, with more neonatal unit admissions related to prematurity but no indicators of greater neonatal morbidity. This trade-off should be discussed with women with late preterm pre-eclampsia to allow shared decision making on timing of delivery.
FUNDING


National Institute for Health Research Health Technology Assessment Programme.",2019,"There were nine serious adverse events in the planned delivery group and 12 in the expectant management group.
","['late preterm pre-eclampsia (PHOENIX', '46 maternity units across England and Wales', '450 women (448 women and 471 infants analysed) were allocated to planned delivery and 451 women (451 women and 475 infants analysed) to', ""in women with late preterm pre-eclampsia from 34 to less than 37 weeks' gestation and a singleton or dichorionic diamniotic twin pregnancy"", 'Between Sept 29, 2014, and Dec 10, 2018, 901 women were recruited', 'women with late preterm pre-eclampsia']","['expectant management', 'planned delivery versus expectant management (usual care) with individual randomisation', 'expectant management (usual care', 'Planned early delivery or expectant management']","['incidence of the co-primary maternal outcome', 'serious adverse events', 'incidence of the co-primary perinatal outcome by intention to treat', 'maternal morbidity and severe hypertension', 'composite of maternal morbidity or recorded systolic blood pressure', 'composite of perinatal deaths or neonatal unit admission up to infant hospital discharge with a non-inferiority hypothesis (non-inferiority margin of 10% difference in incidence', 'neonatal morbidity']","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C4517786', 'cui_str': '475 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C2977407', 'cui_str': 'Dichorionic diamniotic twin pregnancy'}]","[{'cui': 'C2585455', 'cui_str': 'Expectant management (procedure)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0701826', 'cui_str': 'Perinatal death (event)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}]",450.0,0.260126,"There were nine serious adverse events in the planned delivery group and 12 in the expectant management group.
","[{'ForeName': 'Lucy C', 'Initials': 'LC', 'LastName': 'Chappell', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK. Electronic address: lucy.chappell@kcl.ac.uk.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brocklehurst', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, UK.'}, {'ForeName': 'Marcus E', 'Initials': 'ME', 'LastName': 'Green', 'Affiliation': 'Action on Pre-eclampsia, Evesham, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Hunter', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, London, UK.'}, {'ForeName': 'Pollyanna', 'Initials': 'P', 'LastName': 'Hardy', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, UK.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Juszczak', 'Affiliation': 'National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Linsell', 'Affiliation': 'National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Chiocchia', 'Affiliation': 'National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Greenland', 'Affiliation': 'National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Placzek', 'Affiliation': 'National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Townend', 'Affiliation': 'National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Marlow', 'Affiliation': ""UCL EGA Institute for Women's Health, University College London, London, UK.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Sandall', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)31963-4']
986,32433915,Impact of fellow participation on colon adenoma detection rates: a multicenter randomized trial.,"BACKGROUND AND AIMS


There are limited and conflicting data on the impact of fellow participation in improving the colon adenoma detection rate. We performed a multicenter randomized controlled trial to evaluate whether fellow involvement might have a beneficial effect on adenoma detection rate.
METHODS


The trial was conducted at 4 tertiary hospitals between April and December 2019. Eight hundred twelve patients were randomized to undergo colonoscopy performed by a fellow under the supervision of a staff endoscopist or by an attending physician alone.
RESULTS


No significant differences in demographic or adenoma risk factors were detected between the 2 groups. The adenoma detection rate in the intervention group was 44.8% versus 37.1% in the control arm (P = .02). The mean number of adenomas per colonoscopy was significantly higher in the intervention group (0.65 ± 0.3 vs 0.53 ± 0.2 in the control arm, P < .001). The polyp detection rate was 69.7% in the intervention group and 62.5% in the control arm (P = .03), whereas rates of advanced and sessile/serrated adenoma detection were not different between the trial arms (P = .50 and .42, respectively). In the subgroup of more experienced fellows, the adenoma detection rate and polyp detection rate were 49.5% and 75.7%, respectively. No difference was observed between less-experienced fellows and attending physicians alone (P = .53 and 0.86, respectively). The level of bowel preparation and fellow involvement were significant predictors of increased adenoma detection rate in a multivariate analysis.
CONCLUSIONS


Our multicenter trial represents the first prospective validation of the beneficial role of fellow involvement in colonoscopy procedures. (Clinical trial registration number: NCT03908229.).",2020,"Polyp detection rate was 69.7% in the intervention group as compared to 62.5% in the control arm (p=0.03), whereas rates of advanced and sessile/serrated adenoma were not different between the trial arms (p=0.50 and 0.42, respectively).","['four tertiary hospitals between April and December 2019', 'Eight hundred twelve patients']","['Fellow Participation', ""colonoscopy performed by a fellow under staff endoscopist's supervision or by an attending physician alone""]","['demographic or adenoma risk factors', 'rates of advanced and sessile/serrated adenoma', 'Colon Adenoma Detection Rates', 'adenoma detection rate', 'Mean number of adenomas per colonoscopy', 'ADR and PDR', 'Polyp detection rate']","[{'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C1320929', 'cui_str': 'Attending physician'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205348', 'cui_str': 'Sessile'}, {'cui': 'C1266025', 'cui_str': 'Traditional serrated adenoma'}, {'cui': 'C4551463', 'cui_str': 'Colon adenoma'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C1845050', 'cui_str': 'Pigmentary Disorder, Reticulate, with Systemic Manifestations'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}]",812.0,0.134147,"Polyp detection rate was 69.7% in the intervention group as compared to 62.5% in the control arm (p=0.03), whereas rates of advanced and sessile/serrated adenoma were not different between the trial arms (p=0.50 and 0.42, respectively).","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Facciorusso', 'Affiliation': 'Gastroenterology Unit, Department of Medical Sciences, University of Foggia, Foggia, Italy.'}, {'ForeName': 'Vincenzo Rosario', 'Initials': 'VR', 'LastName': 'Buccino', 'Affiliation': 'Gastroenterology Unit, Department of Medical Sciences, University of Foggia, Foggia, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Tonti', 'Affiliation': 'Gastroenterology Unit, Department of Medical Sciences, University of Foggia, Foggia, Italy.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Licinio', 'Affiliation': 'Endoscopy Unit, Ospedale Santissima Annunziata, Taranto, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Del Prete', 'Affiliation': 'Endoscopy Unit, Ospedale A. Perrino, Brindisi, Italy.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Neve', 'Affiliation': 'Endoscopy Unit, Ospedale A. Perrino, Brindisi, Italy.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Di Maso', 'Affiliation': 'Endoscopy Unit, Ospedale Teresa Masselli Mascia, San Severo, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Muscatiello', 'Affiliation': 'Gastroenterology Unit, Department of Medical Sciences, University of Foggia, Foggia, Italy.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.05.015']
987,32439482,Inflammatory and fibroblastic effects of azithromycin on cyclosporine-induced gingival overgrowth in renal transplanted patients with and without scaling: A randomized clinical trial.,"BACKGROUND


This study aimed to evaluate the effect of azithromycin (AZM) on the inflammatory and fibroblastic part of cyclosporine A (CsA)-induced gingival overgrowth (GO) in renal transplanted patients.
METHODS


In this randomized clinical trial, subjects with GO receiving CsA were randomly divided into two groups: those receiving 5-day AZM only (n = 12; group 1) and those receiving scaling and prescribed AZM after 2 months (n = 12; group 2). Both groups were evaluated for several indices (gingival hyperplastic index, plaque and bleeding index, clinical crown length) at the first visit and the 4th and 8th week in group 1, and at the first visit and the 4th, 8th, 12th, and 16th week in group 2.
RESULTS


The sample included 24 individuals. The mean (SD) age of participants was 30.81 (11.13) and 34.80 (9.33) years in group 1 and 2, respectively. Based on ANCOVA, the changes in the hyperplastic index (GHI) and apico-coronal dimension (ACD) of it were statistically significant in professional scaling accompanied by AZM group (P = 0.012 and 0.031, respectively). However, no significant change was observed in mean indices after prescribing AZM in 5-day AZM regimen group (P = 0.664 and 0.882, respectively). According to one-way ANOVA, we found a statistically significant correlation in GHI, ACD, bleeding index (BI), and plaque index (PI) accounting for P = 0.012, 0.003, 0.002, and <0.001, respectively.
CONCLUSIONS


Findings suggest that AZM cannot influence the fibroblastic part of GO in presence of gum inflammation while the therapy can improve GO after resolving it with scaling.",2020,"Both groups were evaluated for several indices (gingival hyperplastic index, plaque and bleeding index, clinical crown length) at the first visit and the 4th and 8th week in group 1, and at the first visit and the 4th, 8th, 12th, and 16th week in group 2.
","['renal transplanted patients', 'The sample included 24 individuals', 'renal transplanted patients with and without scaling', 'subjects with GO receiving CsA']","['cyclosporine A (CsA)-induced gingival overgrowth (GO', 'AZM', 'receiving scaling and prescribed AZM', '5-day AZM', 'azithromycin (AZM', 'azithromycin', 'cyclosporine']","['gingival overgrowth', 'several indices (gingival hyperplastic index, plaque and bleeding index, clinical crown length', 'GHI, ACD, bleeding index (BI), and plaque index (PI', 'Inflammatory and fibroblastic effects', 'hyperplastic index (GHI) and apico-coronal dimension (ACD', 'mean indices', 'professional scaling']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0376480', 'cui_str': 'Gingival enlargement'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}]","[{'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0376480', 'cui_str': 'Gingival enlargement'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0376480', 'cui_str': 'Gingival enlargement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",24.0,0.0349711,"Both groups were evaluated for several indices (gingival hyperplastic index, plaque and bleeding index, clinical crown length) at the first visit and the 4th and 8th week in group 1, and at the first visit and the 4th, 8th, 12th, and 16th week in group 2.
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Beihaghi', 'Affiliation': 'Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Periodontics, School of Dentistry, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Zarei', 'Affiliation': 'Department of Oral Medicine, School of Dentistry, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Azmandian', 'Affiliation': 'Department of Nephrology, Shafa Hospital, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Hamidreza Baghani', 'Initials': 'HB', 'LastName': 'Aval', 'Affiliation': 'Department of Urology, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran. Electronic address: https://mail.google.com/mail/u/0/h/sif60x9sjdad/?&cs=wh&v=b&to=hamidreza_baghani@yahoo.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sahebkar', 'Affiliation': 'Department of Social Medicine, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}]",Journal of oral biosciences,['10.1016/j.job.2020.04.001']
988,31415063,Effect of Home-Based Exercise and Weight Loss Programs on Breast Cancer-Related Lymphedema Outcomes Among Overweight Breast Cancer Survivors: The WISER Survivor Randomized Clinical Trial.,"Importance


To our knowledge, no randomized clinical trials have assessed the effects of the combination of weight loss and home-based exercise programs on lymphedema outcomes.
Objective


To assess weight loss, home-based exercise, and the combination of weight loss and home-based exercise with clinical lymphedema outcomes among overweight breast cancer survivors.
Design, Setting, and Participants


This randomized clinical trial (Women in Steady Exercise Research [WISER] Survivor clinical trial ) of 351 overweight breast cancer survivors with breast cancer-related lymphedema (BCRL) was conducted in conference rooms at academic and community hospitals and in the homes of participants from March 12, 2012, to May 28, 2016; follow-up was conducted for 1 year from the start of the intervention. Statistical analysis by intention to treat was performed from September 26, 2018, to October 28, 2018.
Interventions


A 52-week, home-based exercise program of strength/resistance training twice per week and 180 minutes of walking per week, a weight loss program of 20 weeks of meal replacements and 52 weeks of lifestyle modification counseling, and a combination of the home-based exercise and weight loss programs.
Main Outcomes and Measures


The 12-month change in the percentage of interlimb volume difference.
Results


Of 351 participants, 90 were randomized to the control group (facility-based lymphedema care with no home-based exercise or weight loss intervention), 87 to the exercise intervention group, 87 to the weight loss intervention group, and 87 to the combined exercise and weight loss intervention group; 218 (62.1%) were white, 122 (34.8%) were black, and 11 (3.1%) were of other races or ethnicities. Median time since breast cancer diagnosis was 6 years (range, 1-29 years). Mean (SD) total upper extremity score changes from the objective clinical evaluation were -1.40 (11.10) in the control group, -2.54 (13.20) in the exercise group, -3.54 (12.88) in the weight loss group, and -3.84 (10.09) in the combined group. Mean (SD) overall upper extremity score changes from the self-report survey were -0.39 (2.33) in the control group, -0.12 (2.14) in the exercise group, -0.57 (2.47) in the weight loss group, and -0.62 (2.38) in the combined group. Weight loss from baseline was -0.55% (95% CI, -2.22% to 1.11%) in the control group, -8.06% (95% CI, -9.82% to 6.29%) in the combined group, -7.37% (95% CI, -8.90% to -5.84%) in the weight loss group, and -0.44% (95% CI, -1.81% to 0.93%) in the exercise group.
Conclusions and Relevance


Study results indicate that weight loss, home-based exercise, and combined interventions did not improve BCRL outcomes; a supervised facility-based program of exercise may be more beneficial than a home-based program for improving lymphedema outcomes.
Trial Registration


ClinicalTrials.gov identifier: NCT01515124.",2019,"Weight loss from baseline was -0.55% (95% CI, -2.22% to 1.11%) in the control group, -8.06% (95% CI, -9.82% to 6.29%) in the combined group, -7.37% (95% CI,","['351 participants', 'Breast Cancer-Related Lymphedema Outcomes', 'Overweight Breast Cancer Survivors', '351 overweight breast cancer survivors with breast cancer-related lymphedema (BCRL) was conducted in conference rooms at academic and community hospitals and in the homes of participants from March 12, 2012, to May 28, 2016; follow-up was conducted for 1 year from the start of the intervention', 'group; 218 (62.1%) were white, 122 (34.8%) were black, and 11 (3.1%) were of other races or ethnicities', 'overweight breast cancer survivors']","['home-based exercise program of strength/resistance training twice per week and 180 minutes of walking per week, a weight loss program of 20 weeks of meal replacements and 52 weeks of lifestyle modification counseling, and a combination of the home-based exercise and weight loss programs', 'Home-Based Exercise and Weight Loss Programs', 'WISER', 'control group (facility-based lymphedema care with no home-based exercise or weight loss intervention), 87 to the exercise intervention group, 87 to the weight loss intervention group, and 87 to the combined exercise and weight loss intervention']","['Mean (SD) overall upper extremity score changes', 'Weight loss', 'Median time since breast cancer diagnosis', 'Mean (SD) total upper extremity score changes']","[{'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C4517683', 'cui_str': '3.1 (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2960599', 'cui_str': 'Lymphedema care'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",351.0,0.0590946,"Weight loss from baseline was -0.55% (95% CI, -2.22% to 1.11%) in the control group, -8.06% (95% CI, -9.82% to 6.29%) in the combined group, -7.37% (95% CI,","[{'ForeName': 'Kathryn H', 'Initials': 'KH', 'LastName': 'Schmitz', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State College of Medicine, Hershey.'}, {'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Troxel', 'Affiliation': 'Department of Biostatistics, New York University School of Medicine, New York.'}, {'ForeName': 'Lorraine T', 'Initials': 'LT', 'LastName': 'Dean', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'DeMichele', 'Affiliation': 'Department of Hematology/Oncology, Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Brown', 'Affiliation': 'Department of Population and Public Health Sciences, Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Sturgeon', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State College of Medicine, Hershey.'}, {'ForeName': 'Zi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, Harlem Hospital Center, New York, New York.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Evangelisti', 'Affiliation': 'Department of Hematology/Oncology, Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Spinelli', 'Affiliation': 'Department of Physical Therapy, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Kallan', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Denlinger', 'Affiliation': 'Division of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cheville', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Renate M', 'Initials': 'RM', 'LastName': 'Winkels', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State College of Medicine, Hershey.'}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Chodosh', 'Affiliation': 'Department of Hematology/Oncology, Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Sarwer', 'Affiliation': 'Department of Social and Behavioral Sciences, Temple University, Philadelphia, Pennsylvania.'}]",JAMA oncology,['10.1001/jamaoncol.2019.2109']
989,31448950,The Effect of Tai Chi on Quality of Life in Centrally Obese Adults with Depression.,"Objectives:  The aim of this pilot study was to assess the effects of a  t'ai chi  program on health-related quality of life (HR-QOL) in centrally obese adults with depression.  Methods:  Two hundred thirteen participants were randomly allocated to either a  t'ai chi  intervention group ( n  = 106) or a usual medical care control group ( n  = 107). The  t'ai chi  group involved 3 × 1.5 h supervised and group-based training sessions per week for 24 weeks. Indicators of HR-QOL were assessed by questionnaire at baseline, 12 weeks, and 24 weeks.  Results:  There were significant improvements in favor of the  t'ai chi  group for the SF-36 subscales of physical functioning ( p  < 0.01), role physical ( p  < 0.01), and role emotional ( p  < 0.01) at 12 and 24 weeks. Scores for bodily pain were improved in the control group at 12 weeks ( p  < 0.01) and 24 weeks ( p  < 0.05), but not in the  t'ai chi  group. There was also a significant improvement in favor of the control group in general health ( p  < 0.05) at 12 weeks, but not at 24 weeks. A further analysis showed clinically significant changes in favor of the  t'ai chi  group in physical functioning ( p  < 0.05 or  p  = 0.05), role physical ( p  < 0.05), and role emotional ( p  < 0.05), and in favor of the control group in bodily pain ( p  < 0.05) at 12 and 24 weeks.  Conclusions:  The findings show that  t'ai chi  exercise improved indicators of HR-QOL including physical functioning, role physical, and role emotional in centrally obese adults with depression.",2019,"Scores for bodily pain were improved in the control group at 12 weeks ( p  < 0.01) and 24 weeks ( p  < 0.05), but not in the  t'ai chi  group.","['Two hundred thirteen participants', 'centrally obese adults with depression', 'Centrally Obese Adults with Depression']","[""t'ai chi  program"", ""t'ai chi"", ""t'ai chi  exercise"", ""t'ai chi  intervention group ( n \u2009=\u2009106) or a usual medical care control group""]","['Scores for bodily pain', 'general health', 'indicators of HR-QOL including physical functioning, role physical, and role emotional', 'Indicators of HR-QOL', 'physical functioning', 'SF-36 subscales of physical functioning', 'bodily pain', 'health-related quality of life (HR-QOL', 'role emotional', 'Quality of Life', 'role physical']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",213.0,0.0697349,"Scores for bodily pain were improved in the control group at 12 weeks ( p  < 0.01) and 24 weeks ( p  < 0.05), but not in the  t'ai chi  group.","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'School of Life Sciences, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Williams', 'Affiliation': 'The University of Queensland School of Public Health, Brisbane, Australia.'}, {'ForeName': 'Karam', 'Initials': 'K', 'LastName': 'Kostner', 'Affiliation': 'The University of Queensland School of Medicine, Brisbane, Australia.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Brown', 'Affiliation': 'The University of Queensland School of Human Movement and Nutrition Sciences, Brisbane, Australia.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0050']
990,31448420,Randomized Population Pharmacokinetic Analysis and Safety of Intravenous Acetaminophen for Acute Postoperative Pain in Neonates and Infants.,"Intravenous administration of acetaminophen is an alternative to the oral and rectal routes, which may be contraindicated in particular clinical settings. This randomized, placebo-controlled study of intravenous acetaminophen (Ofirmev, Mallinckrodt Pharmaceuticals, Bedminster, New Jersey) in neonate and infant patients with acute postoperative pain assessed pharmacokinetics (PK) and safety, in addition to efficacy and pharmacodynamics of repeated doses administered over 24 hours. Neonate and infant patients (<2 years of age) who were undergoing surgery or had experienced a traumatic injury and were expected to need pain management for at least 24 hours were enrolled. Subjects were randomly assigned to receive intravenous acetaminophen low dose, intravenous acetaminophen high dose, or placebo. A population PK model of intravenous acetaminophen was updated by combining 581 samples from the current study of 158 neonate and infant subjects with results from a previously developed model. The individual predicted-versus-observed concentrations plots showed that the structural PK model fit the blood and plasma acetaminophen concentration-versus-time profiles in the active and placebo groups. Terminal elimination half-life was prolonged in neonates and younger infants and in intermediate and older infants similar to values in adults. When compared with placebo, total rescue opioid consumption was similar and significantly fewer intravenous acetaminophen patients prematurely discontinued because of treatment-emergent adverse events (P < .01). For intravenous acetaminophen, neonates receiving 12.5 mg/kg every 6 hours had PK profiles similar to younger, intermediate, and older infants, adolescents, and adults weighing <50 kg receiving 15 mg/kg every 6 hours and adults ≥ 50 kg receiving 1000 mg every 6 hours.",2020,Terminal elimination half-life was prolonged in neonates and younger infants and in intermediate and older infants similar to values in adults.,"['neonate and infant patients with acute postoperative pain assessed pharmacokinetics (PK', 'Neonate and infant patients (<2\xa0years of age) who were undergoing surgery or had experienced a traumatic injury and were expected to need pain management for at least 24\xa0hours were enrolled', '158 neonate and infant subjects with results from a previously developed model', 'Neonates and Infants']","['intravenous acetaminophen low dose, intravenous acetaminophen high dose, or placebo', 'placebo', 'acetaminophen', 'Acetaminophen']",['total rescue opioid consumption'],"[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2215257', 'cui_str': 'Acute postoperative pain (finding)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3263723', 'cui_str': 'Injuries'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0855941', 'cui_str': 'Paracetamol increased'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.479318,Terminal elimination half-life was prolonged in neonates and younger infants and in intermediate and older infants similar to values in adults.,"[{'ForeName': 'Gregory B', 'Initials': 'GB', 'LastName': 'Hammer', 'Affiliation': ""Lucile Packard Children's Hospital at Stanford, Stanford, California, USA.""}, {'ForeName': 'Lynne G', 'Initials': 'LG', 'LastName': 'Maxwell', 'Affiliation': ""The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Brad M', 'Initials': 'BM', 'LastName': 'Taicher', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Visoiu', 'Affiliation': ""Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, USA.""}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Cooper', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Szmuk', 'Affiliation': ""Children's Medical Center of Dallas, Dallas, Texas, USA.""}, {'ForeName': 'Leng Hong', 'Initials': 'LH', 'LastName': 'Pheng', 'Affiliation': 'Certara, Princeton, New Jersey, USA.'}, {'ForeName': 'Nathalie H', 'Initials': 'NH', 'LastName': 'Gosselin', 'Affiliation': 'Certara, Princeton, New Jersey, USA.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Bedminster, New Jersey, USA.'}, {'ForeName': 'Krishna', 'Initials': 'K', 'LastName': 'Devarakonda', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Bedminster, New Jersey, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1508']
991,32437937,Causes of fever in primary care in Southeast Asia and the performance of C-reactive protein in discriminating bacterial from viral pathogens.,"OBJECTIVES


This study investigated causes of fever in the primary levels of care in Southeast Asia, and evaluated whether C-reactive protein (CRP) could distinguish bacterial from viral pathogens.
METHODS


Blood and nasopharyngeal swab specimens were taken from children and adults with fever (>37.5 °C) or history of fever (<14 days) in Thailand and Myanmar.
RESULTS


Of 773 patients with at least one blood or nasopharyngeal swab specimen collected, 227 (29.4%) had a target organism detected. Influenza virus type A was detected in 85/227 cases (37.5%), followed by dengue virus (30 cases, 13.2%), respiratory syncytial virus (24 cases, 10.6%) and Leptospira spp. (nine cases, 4.0%). Clinical outcomes were similar between patients with a bacterial or a viral organism, regardless of antibiotic prescription. CRP was higher among patients with a bacterial organism compared with those with a viral organism (median 18 mg/L, interquartile range [10-49] versus 10 mg/L [≤8-22], p = 0.003), with an area under the curve of 0.65 (95% CI 0.55-0.75).
CONCLUSIONS


Serious bacterial infections requiring antibiotics are an exception rather than the rule in the first line of care. CRP testing could assist in ruling out such cases in settings where diagnostic uncertainty is high and routine antibiotic prescription is common. The original CRP randomised controlled trial was registered with ClinicalTrials.gov, number NCT02758821.",2020,"CRP was higher among patients with a bacterial organism compared to those with a viral organism (median 18mg/L, interquartile range [10-49] versus 10mg/L [≤8-22], p-value 0.003), with an area under the curve of 0.65, 95% confidence interval (0.55-0.75).
","['fever in the primary levels of care in Southeast Asia', '773 patients with at least one blood or nasopharyngeal swab specimen collected, 227 (29.4%) had a target organism detected', 'Blood and nasopharyngeal swab specimens were taken from children and adults with fever (>37.5˚C) or history of fever (<14 days) in Thailand and Myanmar']",[],"['respiratory syncytial virus', 'CRP']","[{'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003983', 'cui_str': 'South east Asian country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0006416', 'cui_str': 'Burma'}]",[],"[{'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",773.0,0.237316,"CRP was higher among patients with a bacterial organism compared to those with a viral organism (median 18mg/L, interquartile range [10-49] versus 10mg/L [≤8-22], p-value 0.003), with an area under the curve of 0.65, 95% confidence interval (0.55-0.75).
","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Althaus', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom. Electronic address: thomas.a@tropmedres.ac.'}, {'ForeName': 'Janjira', 'Initials': 'J', 'LastName': 'Thaipadungpanit', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Greer', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Myo Maung Maung', 'Initials': 'MMM', 'LastName': 'Swe', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Myanmar-Oxford Clinical Research Unit (MOCRU), Medical Action Myanmar (MAM), Yangon, Myanmar.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Dittrich', 'Affiliation': 'Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.'}, {'ForeName': 'Pimnara', 'Initials': 'P', 'LastName': 'Peerawaranun', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pieter W', 'Initials': 'PW', 'LastName': 'Smit', 'Affiliation': 'Maasstad Ziekenhuis Hospital, Department of Medical Microbiology, Rotterdam, The Netherlands; Public Health Laboratory (GGD), Amsterdam, The Netherlands.'}, {'ForeName': 'Tri', 'Initials': 'T', 'LastName': 'Wangrangsimakul', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Blacksell', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jonas M', 'Initials': 'JM', 'LastName': 'Winchell', 'Affiliation': 'Division of Bacterial Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Maureen H', 'Initials': 'MH', 'LastName': 'Diaz', 'Affiliation': 'Division of Bacterial Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Nicholas P J', 'Initials': 'NPJ', 'LastName': 'Day', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Smithuis', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom; Myanmar-Oxford Clinical Research Unit (MOCRU), Medical Action Myanmar (MAM), Yangon, Myanmar.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Turner', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom; Cambodia-Oxford Medical Research Unit (COMRU), Angkor Hospital for Children, Siem Reap, Cambodia.'}, {'ForeName': 'Yoel', 'Initials': 'Y', 'LastName': 'Lubell', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.05.016']
992,31436843,"Attitudes, knowledge and sexual behavior among Finnish adolescents before and after an intervention.","Adolescents are an important target group for sexual health promotion, and there are numerous programs and interventions carried out in this field. The aim of this study is to describe adolescents' attitudes, knowledge and sexual behavior before and after a sexual health promotion intervention. The intervention was developed in the study and consisted of three elements: (i) class-room session, (ii) information materials and (iii) free condom distribution. The study was carried out in eight randomly selected vocational schools in Finland. The participants were first year students aged 15-19 years. The data were collected using an electronic questionnaire before intervention (intervention baseline n = 500, control baseline n = 183) and two times after the intervention (intervention first follow-up n = 173/second follow-up n = 202, control first follow-up n = 115/second follow-up n = 46). There were significant differences before and after the intervention concerning better knowledge and more frequent testing for sexually transmitted infections (STIs). Schools are an important environment to reach adolescents during the phase where their sexual health is developing and there is an increased risk of STI transmission. More school-based interventions are therefore needed, and the results of this study can be utilized when developing sexual health promotion interventions among adolescents.",2020,There were significant differences before and after the intervention concerning better knowledge and more frequent testing for sexually transmitted infections (STIs).,"['eight randomly selected vocational schools in Finland', 'adolescents', 'participants were first year students aged 15-19 years']","['electronic questionnaire before intervention (intervention baseline n\u2009=\u2009500, control baseline n\u2009=\u2009183) and two times after the intervention (intervention first follow-up n\u2009=\u2009173/second follow-up n\u2009=\u2009202, control first follow-up n\u2009=\u2009115/second follow-up']","['Attitudes, knowledge and sexual behavior']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}]",,0.0127669,There were significant differences before and after the intervention concerning better knowledge and more frequent testing for sexually transmitted infections (STIs).,"[{'ForeName': 'Marja', 'Initials': 'M', 'LastName': 'Pakarinen', 'Affiliation': 'Faculty of Social Sciences, Health Sciences.'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Kylmä', 'Affiliation': 'Faculty of Social Sciences, Health Sciences.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Helminen', 'Affiliation': 'Faculty of Social Sciences, Health Sciences, Science Center, Tampere University Hospital, Tampere University, PL 100, 33014 Tampereen yliopisto, Tampere, Finland.'}, {'ForeName': 'Tarja', 'Initials': 'T', 'LastName': 'Suominen', 'Affiliation': 'Faculty of Social Sciences, Health Sciences.'}]",Health promotion international,['10.1093/heapro/daz074']
993,31433895,"Ultrasound-guided dorsal penile nerve block vs neurostimulator-guided pudendal nerve block in children undergoing hypospadias surgery: A prospective, randomized, double-blinded trial.","BACKGROUND AND AIMS


Hypospadias is a common congenital malformation in pediatric patients. Surgical repair of this malformation is a painful procedure and has long-term effects. Pudendal and penile nerve blocks are commonly preferred techniques for maintaining postoperative analgesia. However, the conventional landmark-based penile block technique involves numerous potential complications and provides a shorter analgesic period compared to the pudendal block. A promising ultrasound-guided dorsal penile nerve block was recently described. We aimed to compare the analgesic effectiveness of ultrasound-guided penile nerve block with that of neurostimulator-guided pudendal nerve block.
METHOD


Thirty-three patients aged 1-7 years were included in this prospective, double-blinded, randomized controlled trial. Patients were divided into two groups and received either ultrasound-guided dorsal penile nerve block or neurostimulator-guided pudendal nerve block. All blocks were performed by the same two anesthesiologists, and the same surgeons performed the surgical procedures. The Face, Legs, Activity, Cry, and Consolability (FLACC) scale was used for postoperative pain management. The primary outcome of the study was time to first analgesic requirement. Secondary outcomes were FLACC scores at different time points, and types and cumulative doses of analgesic drugs.
RESULTS


Dorsal penile nerve block provided longer analgesia than pudendal nerve block (32.29 ± 5.47 hours and 21.13 ± 3.53 hours, respectively; differences in mean: 11.16, 95% CI: 7.873-14.465) (P < .001). FLACC scores at the time of first analgesic requirement were significantly lower in dorsal penile nerve block group than pudendal nerve block group (median [IQR]: 2 [2-2.5] and 3 [3-5], respectively; differences in median: -1, 95% CI: -1.851 to -0.149) (P < .001).
CONCLUSION


Ultrasound-guided dorsal penile nerve block provided a longer analgesic period and reduced opioid consumption compared to neurostimulator-guided pudendal nerve block.",2019,Dorsal penile nerve block provided longer analgesia than pudendal nerve block (32.29 ± 5.47 hours and 21.13 ± ,"['Thirty-three patients aged 1-7\xa0years', 'pediatric patients', 'children undergoing hypospadias surgery']","['Ultrasound-guided dorsal penile nerve block vs neurostimulator-guided pudendal nerve block', 'ultrasound-guided penile nerve block with that of neurostimulator-guided pudendal nerve block', 'ultrasound-guided dorsal penile nerve block or neurostimulator-guided pudendal nerve block']","['Face, Legs, Activity, Cry, and Consolability (FLACC) scale', 'FLACC scores at the time of first analgesic requirement', 'FLACC scores at different time points, and types and cumulative doses of analgesic drugs', 'analgesic effectiveness', 'time to first analgesic requirement', 'opioid consumption']","[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0848558', 'cui_str': 'Hypospadias'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0228964', 'cui_str': 'Dorsal Nerve of Penis'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0582124', 'cui_str': 'Neurostimulator, device (physical object)'}, {'cui': 'C0228959', 'cui_str': 'Pudendal Nerve'}, {'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}]","[{'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",33.0,0.217484,Dorsal penile nerve block provided longer analgesia than pudendal nerve block (32.29 ± 5.47 hours and 21.13 ± ,"[{'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Aksu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Kocaeli University, Faculty of Medicine, Kocaeli, Turkey.'}, {'ForeName': 'Mustafa Alper', 'Initials': 'MA', 'LastName': 'Akay', 'Affiliation': 'Department of Pediatric Surgery, Kocaeli University, Faculty of Medicine, Kocaeli, Turkey.'}, {'ForeName': 'Mehmet Celal', 'Initials': 'MC', 'LastName': 'Şen', 'Affiliation': 'Department of Pediatric Surgery, Kocaeli University, Faculty of Medicine, Kocaeli, Turkey.'}, {'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Gürkan', 'Affiliation': 'Department of Anesthesiology and Reanimation, Kocaeli University, Faculty of Medicine, Kocaeli, Turkey.'}]",Paediatric anaesthesia,['10.1111/pan.13727']
994,32058555,Evaluation of Prediction Models for Identifying Malignancy in Pulmonary Nodules Detected via Low-Dose Computed Tomography.,"Importance


Malignancy prediction models based on participant-related characteristics and imaging parameters from low-dose computed tomography (CT) may improve decision-making regarding nodule management and diagnosis in lung cancer screening.
Objective


To externally validate 5 malignancy prediction models that were developed in screening settings, compared with 3 models that were developed in clinical settings, in terms of discrimination and absolute risk calibration among participants in the German Lung Cancer Screening Intervention trial.
Design, Setting, and Participants


In this population-based diagnostic study, malignancy probabilities were estimated by applying 8 prediction models to data from 1159 participants in the intervention arm of the Lung Cancer Screening Intervention trial, a randomized clinical trial conducted from October 23, 2007, to April 30, 2016, with ongoing follow-up. This analysis considers end points up to 1 year after individuals' last screening visit. Inclusion criteria for participants were at least 1 noncalcified pulmonary nodule detected on any of 5 annual screening visits, receiving a lung cancer diagnosis within the active screening phase of the Lung Cancer Screening Intervention trial, and an unequivocal identification of the malignant nodules. Data analysis was performed from February 1, 2019, through December 5, 2019.
Interventions


Five annual rounds of low-dose multislice CT.
Main Outcomes and Measures


Discrimination ability and calibration of malignancy probabilities estimated by 5 models developed in data from screening studies (4 Pan-Canadian Early Detection of Lung Cancer Study [PanCan] models using a parsimonious approach including nodule spiculation [PanCan-1b] or a comprehensive approach including nodule spiculation [PanCan-2b], and PanCan-2b replacing the nodule diameter variable with mean diameter [PanCan-MD] or volume [PanCan-VOL], as well as a model developed by the UK Lung Cancer Screening trial) and 3 models developed in clinical settings (US Department of Veterans Affairs, Mayo Clinic, and Peking University People's Hospital).
Results


A total of 1159 participants (median [range] age, 57.63 [50.34-71.89] years; 763 [65.8%] men) with 3903 pulmonary nodules were included in this study. For nodules detected in the prevalence round of CT, the PanCan models showed excellent discrimination (PanCan-1b: area under the curve [AUC], 0.93 [95% CI, 0.87-0.99]; PanCan-2b: AUC, 0.94 [95% CI, 0.89-0.99]; PanCan-MD: AUC, 0.94 [95% CI, 0.91-0.98]; PanCan-VOL: AUC, 0.94 [95% CI, 0.90-0.98]), and all of the screening models except PanCan-MD and PanCan-VOL showed acceptable calibration (PanCan-1b: Spiegelhalter z = -1.081; P = .28; PanCan-2b: Spiegelhalter z = 0.436; P = .67; PanCan-MD: Spiegelhalter z = 3.888; P < .001; PanCan-VOL: Spiegelhalter z = 1.978; P = .05; UK Lung Cancer Screening trial: Spiegelhalter z = -1.076; P = .28), whereas the other models showed worse discrimination and calibration, from an AUC of 0.58 (95% CI, 0.46-0.70) for the UK Lung Cancer Screening trial model to an AUC of 0.89 (95% CI, 0.82-0.97) for the Mayo Clinic model.
Conclusions and Relevance


This diagnostic study found that PanCan models showed excellent discrimination and calibration in prevalence screenings, confirming their ability to improve nodule management in screening settings, although calibration to nodules detected in follow-up scans should be improved. The models developed by the Mayo Clinic, Peking University People's Hospital, Department of Veterans Affairs, and UK Lung Cancer Screening Trial did not perform as well.",2020,"Spiegelhalter z = 1.978; P = .05; UK Lung Cancer Screening trial: Spiegelhalter z = -1.076; P = .28), whereas the other models showed worse discrimination and calibration, from an AUC of 0.58 (95% CI, 0.46-0.70) for the UK Lung Cancer Screening trial model to an AUC of 0.89 (95% CI, 0.82-0.97) for the Mayo Clinic model.
","['Inclusion criteria for participants were at least 1 noncalcified pulmonary nodule detected on any of 5 annual screening visits, receiving a lung cancer diagnosis within the active screening phase of the Lung Cancer Screening Intervention trial, and an unequivocal identification of the malignant nodules', '1159 participants (median [range] age, 57.63', 'participants in the German Lung Cancer Screening Intervention trial', '1159 participants in the intervention arm of the Lung Cancer Screening Intervention trial, a randomized clinical trial conducted from October 23, 2007, to April 30, 2016, with ongoing follow-up', '50.34-71.89] years; 763 [65.8%] men) with 3903 pulmonary nodules']",['low-dose computed tomography (CT'],"[""nodule spiculation [PanCan-1b] or a comprehensive approach including nodule spiculation [PanCan-2b], and PanCan-2b replacing the nodule diameter variable with mean diameter [PanCan-MD] or volume [PanCan-VOL], as well as a model developed by the UK Lung Cancer Screening trial) and 3 models developed in clinical settings (US Department of Veterans Affairs, Mayo Clinic, and Peking University People's Hospital""]","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0028259', 'cui_str': 'Nodule (morphologic abnormality)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0028259', 'cui_str': 'Nodule (morphologic abnormality)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0454788', 'cui_str': 'Mayo (geographic location)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]",1159.0,0.249074,"Spiegelhalter z = 1.978; P = .05; UK Lung Cancer Screening trial: Spiegelhalter z = -1.076; P = .28), whereas the other models showed worse discrimination and calibration, from an AUC of 0.58 (95% CI, 0.46-0.70) for the UK Lung Cancer Screening trial model to an AUC of 0.89 (95% CI, 0.82-0.97) for the Mayo Clinic model.
","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'González Maldonado', 'Affiliation': 'Division of Cancer Epidemiology, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Delorme', 'Affiliation': 'Division of Radiology, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Hüsing', 'Affiliation': 'Division of Cancer Epidemiology, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Erna', 'Initials': 'E', 'LastName': 'Motsch', 'Affiliation': 'Division of Cancer Epidemiology, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Kauczor', 'Affiliation': 'Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany.'}, {'ForeName': 'Claus-Peter', 'Initials': 'CP', 'LastName': 'Heussel', 'Affiliation': 'Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Kaaks', 'Affiliation': 'Division of Cancer Epidemiology, German Cancer Research Center, Heidelberg, Germany.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.21221']
995,32133910,Increased dopamine availability magnifies nicotine effects on cognitive control: A pilot study.,"INTRODUCTION AND OBJECTIVES


The ability to adapt to new task demands flexibly and to stabilise performance in the presence of distractors is termed cognitive control and is mediated by dopaminergic and cholinergic neurotransmission. We aimed to test the hypothesis that the effect of the cholinergic agonist nicotine on cognitive control depends on baseline dopamine levels.
METHODS


Thirty-eight healthy non-smokers (16 males;  M age =24.05 years) performed a cognitive control task including distractor and switch trials twice. Subjects were split into two parallel groups. One group received 2 g of L-tyrosine two hours prior to testing to manipulate dopamine availability experimentally, while the other group received placebo on both days. One hour later, both groups received in a within-subject design: on one day, a 7 mg nicotine patch; on the other day, a matched placebo. Response time costs for distractor and switch trials served as measures of cognitive stability and flexibility.
RESULTS


Nicotinic modulation reduced response time costs in switch trials and increased costs in distractor trials (nicotine×condition,  p =0.027) with a trend-wise interaction between nicotine, L-tyrosine and trial type (nicotine×L-tyrosine×condition,  p =0.068), which was due to stronger nicotine effects under L-tyrosine.
CONCLUSIONS


Our data provide preliminary evidence that nicotine has opponent effects on cognitive stability and flexibility. Subjects who received the dopamine precursor L-tyrosine were more prone to nicotine effects on behaviours, which are improvements in cognitive flexibility at the cost of decreased cognitive stability.",2020,"Subjects who received the dopamine precursor L-tyrosine were more prone to nicotine effects on behaviours, which are improvements in cognitive flexibility at the cost of decreased cognitive stability.","['Thirty-eight healthy non-smokers (16 males;  M age =24.05 years', 'cognitive control']","['cholinergic agonist nicotine', 'dopamine precursor L-tyrosine', 'placebo', 'nicotine', 'nicotine patch', 'cognitive control task including distractor and switch trials twice']","['cognitive stability and flexibility', 'cognitive flexibility', 'Response time costs', 'response time costs']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C4554605', 'cui_str': 'Nonsmokers'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0242894', 'cui_str': 'Acetylcholine Agonists'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0041485', 'cui_str': 'L-tyrosine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1720725', 'cui_str': 'Twice'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",38.0,0.0265435,"Subjects who received the dopamine precursor L-tyrosine were more prone to nicotine effects on behaviours, which are improvements in cognitive flexibility at the cost of decreased cognitive stability.","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ahrens', 'Affiliation': 'Biological Psychology, Department of Psychology, School of Medicine and Health Sciences, Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Laux', 'Affiliation': 'Biological Psychology, Department of Psychology, School of Medicine and Health Sciences, Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Müller', 'Affiliation': 'Biological Psychology, Department of Psychology, School of Medicine and Health Sciences, Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Christiane M', 'Initials': 'CM', 'LastName': 'Thiel', 'Affiliation': 'Biological Psychology, Department of Psychology, School of Medicine and Health Sciences, Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120907989']
996,32437857,"Is a two-step impression mandatory for complete denture fabrication on the severely resorbed mandible? A randomized trial on mastication, patient satisfaction and adjustments.","OBJECTIVES


To compare one- vs two-step impression procedures for the provision of conventional complete dentures (CCDs) for edentulous individuals with severe mandibular resorption, in terms of (1) masticatory performance and ability; (2) satisfaction with mandibular CCDs; and (3) post-delivery adjustments.
METHODS


Fifty-two patients requiring maxillary + mandibular CCDs were randomly divided into two parallel arms according to the impression method of the mandibular ridge: (SI) single impression with stock trays (irreversible hydrocolloid); (TI) two-step impression in custom trays, with border molding (impression compound) followed by the impression itself (polyether). Mastication performance was evaluated by a colorimetric test, whereas patients answered questions on masticatory ability and satisfaction with mandibular CCDs (100-mm visual analogue scale). The number of post-delivery sessions for adjustments were also quantified. Outcomes were assessed at 3 and 6 months after delivery.
RESULTS


The masticatory performance was similar for both groups, regardless of time (3 months, P = 0.62; 6 months, P = 0.61). No significant difference was found for patient-reported (P > 0.05), i.e. masticatory ability (general ease of chewing and quality of grinding food; ability to chew specific foods), general satisfaction with the mandibular CCD (general satisfaction, comfort, aesthetics, ability to speak and to perform correct cleaning, retention and stability). Both methods resulted in a similar number of post-delivery adjustment sessions [SI: 3.8 (1.7); TI: 3.2 (1.4); P = 0.09].
CONCLUSIONS


Compared to a traditional approach, CCDs obtained from a single impression achieve similar masticatory performance/ability and patient satisfaction, even in patients with severely reabsorbed mandibular ridge. Both methods demand the same amount of post-delivery adjustment.
CLINICAL SIGNIFICANCE


A simplified impression technique which eliminates the secondary impression can provide CCDs of good clinical quality, which influences the OHRQoL, and satisfaction in the same extent they would by a two-step procedure, even for patients with severely reabsorbed mandibular ridges (ClinicalTrials.gov: NCT02339194).",2020,"The masticatory performance was similar for both groups, regardless of time (3 months, P = 0.62; 6 months, P = 0.61).","['patients with severely reabsorbed mandibular ridge', 'Fifty-two patients requiring maxillary\u2009+\u2009mandibular CCDs', 'edentulous individuals with severe mandibular resorption, in terms of (1) masticatory performance and ability; (2) satisfaction with mandibular CCDs; and (3) post-delivery adjustments']","['impression method of the mandibular ridge: (SI) single impression with stock trays (irreversible hydrocolloid); (TI) two-step impression in custom trays, with border molding (impression compound) followed by the impression itself (polyether', 'conventional complete dentures (CCDs']","['masticatory performance', 'Mastication performance', 'masticatory ability (general ease of chewing and quality of grinding food; ability to chew specific foods), general satisfaction with the mandibular CCD (general satisfaction, comfort, aesthetics, ability to speak and to perform correct cleaning, retention and stability', 'masticatory ability and satisfaction with mandibular CCDs (100-mm visual analogue scale', 'masticatory performance/ability and patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0453908', 'cui_str': 'Stocking'}, {'cui': 'C0184054', 'cui_str': 'Tray'}, {'cui': 'C0020266', 'cui_str': 'Hydrocolloid'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0426103', 'cui_str': 'Fetal head molding'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}]","[{'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0185051', 'cui_str': 'Removal by grinding'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0566339', 'cui_str': 'Ability to chew'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0008928', 'cui_str': 'Cleidocranial dysostosis'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0564214', 'cui_str': 'Ability to speak'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",52.0,0.0678577,"The masticatory performance was similar for both groups, regardless of time (3 months, P = 0.62; 6 months, P = 0.61).","[{'ForeName': 'Ivo S', 'Initials': 'IS', 'LastName': 'Albuquerque', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará (FFOE-UFC), Fortaleza, Brazil.'}, {'ForeName': 'Karina M', 'Initials': 'KM', 'LastName': 'Freitas-Pontes', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará (FFOE-UFC), Fortaleza, Brazil. Electronic address: kamatthes@yahoo.com.br.'}, {'ForeName': 'Raphael F', 'Initials': 'RF', 'LastName': 'de Souza', 'Affiliation': 'Oral Health and Society, Faculty of Dentistry, McGill University, 2001 McGill College Ave, Suite 500, Montreal, Quebec, Canada.'}, {'ForeName': 'Wagner A', 'Initials': 'WA', 'LastName': 'Negreiros', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará (FFOE-UFC), Fortaleza, Brazil.'}, {'ForeName': 'Marcelo B', 'Initials': 'MB', 'LastName': 'Ramos', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará (FFOE-UFC), Fortaleza, Brazil.'}, {'ForeName': 'Raniel F', 'Initials': 'RF', 'LastName': 'Peixoto', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará (FFOE-UFC), Fortaleza, Brazil.'}, {'ForeName': 'Rômulo R', 'Initials': 'RR', 'LastName': 'Regis', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará (FFOE-UFC), Fortaleza, Brazil.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103357']
997,32441760,"A peer navigation intervention to prevent HIV among mixed immigrant status Latinx GBMSM and transgender women in the United States: outcomes, perspectives and implications for PrEP uptake.","The Latinx population in the United States is disproportionately affected by HIV. Our community-based participatory research partnership developed, implemented and evaluated a Spanish-language peer navigation intervention designed to increase HIV testing and condom use among social networks of immigrant Spanish-speaking Latinx gay, bisexual and other men who have sex with men (GBMSM) and transgender women (TW). We randomized 21 social networks of Latinx GBMSM and TW, ages 18-55 years, to the intervention, known as HOLA, or a waitlist control group. Social network participants (n = 166) completed structured assessments at baseline and 12-month follow-up (24 months after baseline). Follow-up retention was 95%. Individual in-depth interviews with a sample of participants documented their intervention-related experiences, needs, and priorities to inform future research. At follow-up, HOLA participants reported increased HIV testing (adjusted odds ratio = 8.3; 95% CI = 3.0-23.0; P < 0.0001). All study participants reported increased condom use; there was no significant difference between HOLA and waitlist control participants. In-depth interviews identified critical intervention elements and impacts and community needs and priorities. The HOLA intervention is effective for increasing HIV testing among Latinx GBMSM and TW, an initial step within the HIV prevention and care continua, and may be adaptable to promote pre-exposure prophylaxis uptake.",2020,"At follow-up, HOLA participants reported increased HIV testing (adjusted odds ratio = 8.3; 95% CI = 3.0-23.0; P < 0.0001).","['Social network participants (n\u2009=\u2009166', 'immigrant Spanish-speaking Latinx gay, bisexual and other men who have sex with men (GBMSM) and transgender women (TW']","['HOLA intervention', 'peer navigation intervention']",['HIV testing'],"[{'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0019898', 'cui_str': 'Queers'}, {'cui': 'C0005639', 'cui_str': 'Bisexuality'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0459958', 'cui_str': 'HIV screening'}]",21.0,0.0335094,"At follow-up, HOLA participants reported increased HIV testing (adjusted odds ratio = 8.3; 95% CI = 3.0-23.0; P < 0.0001).","[{'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Rhodes', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Alonzo', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Lilli', 'Initials': 'L', 'LastName': 'Mann-Jackson', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Eunyoung Y', 'Initials': 'EY', 'LastName': 'Song', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Amanda E', 'Initials': 'AE', 'LastName': 'Tanner', 'Affiliation': 'Department of Public Health Education, University of North Carolina Greensboro, Greensboro, NC 27402, USA.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Garcia', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Smart', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Logan S', 'Initials': 'LS', 'LastName': 'Baker', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Eng', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, Rosenau Hall, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Reboussin', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}]",Health education research,['10.1093/her/cyaa010']
998,32122621,Surgical outcomes of plication versus resection in basic type of intermittent exotropia.,"OBJECTIVES


To compare the surgical outcomes of plication versus resection in basic type of intermittent exotropia.
DESIGN


Prospective interventional study.
PARTICIPANTS


60 patients above 6 years of age with diagnosis of basic type of intermittent exotropia.
METHODS


A randomized study was conducted in 60 patients above 6 years of age with diagnosis of basic type of intermittent exotropia. They were equally divided in two groups by computer generated random number table. Group A underwent recession and plication (RP) and group B underwent recession and resection (RR) based on post patch deviation with constant 8 mm lateral rectus recession in both groups. Parameters assessed were postoperative alignment, cosmetic outcome, improvement in binocularity & stereoacuity and dose effect. Successful outcome was defined as post patch deviation ≤ 10 Prism diopters (PD) of exophoria/exotropia to < 5 PD of esophoria/esotropia at 12 months follow up.
RESULTS


The mean preoperative and postoperative deviation was 44.67 ± 4.5 PD and 10.13 ± 3.6 PD respectively in group A and 43.17 ± 4.8 PD and 9.40 ± 3.3 PD respectively in group B (p = 0.423). The exodrift at 12 months follow up was 4.4 ± 2.8 PD in group A and 4.67 ± 3.29 PD in group B. There was statistically no significant difference in outcomes between the two groups. Mean effect of MR plication at last follow up was 5.91 PD/mm and MR resection was 5.5 PD/mm (p = 0.877).
CONCLUSION


Both procedures achieved acceptable ocular alignment and had a comparable dose effect. Plication has certain added advantages over resection hence may be preferred as an alternate tightening procedure.",2020,B. There was statistically no significant difference in outcomes between the two groups.,['60 patients above 6 years of age with diagnosis of basic type of intermittent exotropia'],"['plication versus resection', 'recession and plication (RP) and group B underwent recession and resection (RR) based on post patch deviation with constant 8 mm lateral rectus recession']","['Mean effect of MR plication', 'postoperative alignment, cosmetic outcome, improvement in binocularity & stereoacuity and dose effect', 'mean preoperative and postoperative deviation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0423062', 'cui_str': 'Intermittent exotropia (disorder)'}]","[{'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0333047', 'cui_str': 'Recession (morphologic abnormality)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0395310', 'cui_str': 'Lateral rectus recession (procedure)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C1275505', 'cui_str': 'Stereoscopic acuity (observable entity)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}]",60.0,0.03212,B. There was statistically no significant difference in outcomes between the two groups.,"[{'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Anand', 'Affiliation': 'Department of Ophthalmology, Guru Nanak Eye Centre, Maulana Azad Medical College, New Delhi, India.'}, {'ForeName': 'Siddharth', 'Initials': 'S', 'LastName': 'Baindur', 'Affiliation': 'Department of Ophthalmology, Guru Nanak Eye Centre, Maulana Azad Medical College, New Delhi, India.'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Dhiman', 'Affiliation': 'Department of Ophthalmology, Guru Nanak Eye Centre, Maulana Azad Medical College, New Delhi, India. Electronic address: dr.shwetadhiman@yahoo.com.'}, {'ForeName': 'Paromita', 'Initials': 'P', 'LastName': 'Dutta', 'Affiliation': 'Department of Ophthalmology, Guru Nanak Eye Centre, Maulana Azad Medical College, New Delhi, India.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Mishra', 'Affiliation': 'Department of Ophthalmology, Guru Nanak Eye Centre, Maulana Azad Medical College, New Delhi, India.'}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Department of Ophthalmology, Guru Nanak Eye Centre, Maulana Azad Medical College, New Delhi, India.'}, {'ForeName': 'Priyadarshini', 'Initials': 'P', 'LastName': 'Suresh', 'Affiliation': 'Department of Ophthalmology, Guru Nanak Eye Centre, Maulana Azad Medical College, New Delhi, India.'}]",Canadian journal of ophthalmology. Journal canadien d'ophtalmologie,['10.1016/j.jcjo.2020.01.009']
999,32437626,Addition of Povidone-Iodine to Fluoride Varnish for Dental Caries: A Randomized Clinical Trial.,"INTRODUCTION


Dental caries is the most common chronic childhood disease. Products of metabolism by bacteria populating the tooth surface induce development and progression of cavities.
OBJECTIVES


We sought to determine whether a polyvinylpyrrolidone-iodine (PVP-I; povidone-iodine) and NaF topical varnish was superior to one containing only NaF in prevention of new dental caries lesions in a single-center randomized active-controlled trial based on a double-blind, parallel-group design.
METHODS


The site was Pohnpei State, Federated States of Micronesia. The study population was healthy children 49 to 84 mo old who were enrolled in early childhood education: 284 were randomized (1:1 allocation), and 273 were included in year 1 analysis and 262 in year 2. The test varnish contained 10% PVP-I and 5.0% NaF. The comparator contained only 5.0% NaF but was otherwise identical. Varnishes were applied every 3 mo during 2 y. The primary outcome was the surface-level primary molar caries lesion increment (d 2-4 mfs) at 2 y. Caries lesion increments from baseline to year 1 and year 2 were compared between conditions with log-linear regression, adjusting for age and sex and whether the tooth was sound at baseline (free of caries lesions).
RESULTS


At year 1, the caries lesion increment for primary molars sound at baseline was 0.9 surfaces (SD = 1.5) for the test varnish versus 1.8 (SD = 2.2) for the comparator varnish with fluoride alone (adjusted rate ratio, 0.50; 95% CI, 0.31 to 0.81; P = .005). At year 2, the caries lesion increment for primary molars sound at baseline was 2.3 surfaces (SD = 2.8) for the test varnish as compared with 3.3 (SD = 2.7) for the comparator (adjusted rate ratio, 0.74; 95% CI, 0.52 to 1.03; P = .073). Teeth that were already cavitated at baseline did not show a preventive effect. There were no harms.
CONCLUSIONS


A dental varnish containing PVP-I and NaF is effective in the primary prevention of cavities in the primary dentition (NCT03082196).
KNOWLEDGE TRANSFER STATEMENT


This study demonstrates that periodic application of a varnish containing NaF and PVP-I is effective in prevention of caries lesions and useful in assessing the potential of combined treatment.",2020,"A dental varnish containing PVP-I and NaF is effective in the primary prevention of cavities in the primary dentition (NCT03082196).
","['healthy children 49 to 84 mo old who were enrolled in early childhood education: 284 were randomized (1:1 allocation), and 273 were included in year 1 analysis and 262 in year 2', 'Dental Caries']","['Fluoride Varnish', 'varnish containing NaF and PVP-I', 'polyvinylpyrrolidone-iodine (PVP-I; povidone-iodine) and NaF topical varnish', 'Povidone-Iodine']","['surface-level primary molar caries lesion increment', 'caries lesion increment']","[{'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",284.0,0.50793,"A dental varnish containing PVP-I and NaF is effective in the primary prevention of cavities in the primary dentition (NCT03082196).
","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Milgrom', 'Affiliation': 'Department of Oral Health Sciences, School of Dentistry, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Tut', 'Affiliation': 'Department of Oral Health Sciences, School of Dentistry, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rothen', 'Affiliation': 'Regional Clinical Dental Research Center, Institute of Translational Health Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mancl', 'Affiliation': 'Department of Oral Health Sciences, School of Dentistry, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gallen', 'Affiliation': 'Department of Dental Services, Pohnpei State Department of Health Services, Kolonia, Federated States of Micronesia.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Tanzer', 'Affiliation': 'Department of Oral and Maxillofacial Diagnostic Sciences, University of Connecticut Health, Farmington, CT, USA.'}]",JDR clinical and translational research,['10.1177/2380084420922968']
1000,32438479,Long-term results of a randomized study comparing parathyroidectomy with cinacalcet for treating tertiary hyperparathyroidism.,"Tertiary hyperparathyroidism is a common cause of hypercalcemia after kidney transplantation (KT) and has been associated with renal dysfunction, bone mineral density loss, and increased risk of fracture and cardiovascular events. In a previous 12-month clinical trial, we demonstrated that subtotal parathyroidectomy was more effective than cinacalcet for controlling hypercalcemia. In the current study, we retrospectively evaluate whether this effect is maintained after 5 years of follow-up. In total, 24 patients had data available at 5 years, 13 in the cinacalcet group and 11 in the parathyroidectomy group. At 5 years, 7 of 11 patients (64%) in the parathyroidectomy group and 6 of 13 patients (46%) in the cinacalcet group (P = .44) showed normocalcemia. However, recurrence of hypercalcemia was only observed in the cinacalcet group (P = .016). Subtotal parathyroidectomy retained a greater reduction in intact parathyroid hormone (iPTH) compared with cinacalcet group. No differences were observed in kidney function and incidence of fragility fractures between both groups. Cinacalcet was discontinued in 5 out of 13 patients. In conclusion, in kidney transplant patients with tertiary hyperparathyroidism recurrence of hypercalcemia after 5-year follow-up is more frequent in cinacalcet than after subtotal parathyroidectomy.",2020,Subtotal parathyroidectomy retained a greater reduction of intact parathyroid hormone (iPTH) compared with cinacalcet group.,"['hypercalcemia after kidney transplantation (KT', 'kidney transplant patients with tertiary hyperparathyroidism recurrence', '24 patients had data available at 5 years, 13 in the cinacalcet group and 11 in the parathyroidectomy group']","['parathyroidectomy', 'subtotal parathyroidectomy', 'Subtotal parathyroidectomy']","['recurrence of hypercalcemia', 'intact parathyroid hormone (iPTH', 'hypercalcemia', 'kidney function and incidence of fragility fractures', 'normocalcemia']","[{'cui': 'C0020437', 'cui_str': 'Hypercalcemia'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271858', 'cui_str': 'Tertiary hyperparathyroidism'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1337242', 'cui_str': 'cinacalcet'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}]","[{'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}, {'cui': 'C0193697', 'cui_str': 'Subtotal parathyroidectomy'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0020437', 'cui_str': 'Hypercalcemia'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4760971', 'cui_str': 'Fragility fracture'}]",24.0,0.0524296,Subtotal parathyroidectomy retained a greater reduction of intact parathyroid hormone (iPTH) compared with cinacalcet group.,"[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Moreno', 'Affiliation': ""Department of Surgery, Hospital Universitari de Bellvitge, University of Barcelona, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Coloma', 'Affiliation': ""Nephrology Department, Hospital Universitari de Bellvitge, University of Barcelona, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'José V', 'Initials': 'JV', 'LastName': 'Torregrosa', 'Affiliation': 'Nephrology and Renal Transplant Service, Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Montero', 'Affiliation': ""Nephrology Department, Hospital Universitari de Bellvitge, University of Barcelona, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Francos', 'Affiliation': ""Department of Surgery, Hospital Universitari de Bellvitge, University of Barcelona, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Sergi', 'Initials': 'S', 'LastName': 'Codina', 'Affiliation': ""Nephrology Department, Hospital Universitari de Bellvitge, University of Barcelona, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Manonelles', 'Affiliation': ""Nephrology Department, Hospital Universitari de Bellvitge, University of Barcelona, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'Bestard', 'Affiliation': ""Nephrology Department, Hospital Universitari de Bellvitge, University of Barcelona, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Arantxa', 'Initials': 'A', 'LastName': 'García-Barrasa', 'Affiliation': ""Department of Surgery, Hospital Universitari de Bellvitge, University of Barcelona, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Melilli', 'Affiliation': ""Nephrology Department, Hospital Universitari de Bellvitge, University of Barcelona, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Cruzado', 'Affiliation': ""Nephrology Department, Hospital Universitari de Bellvitge, University of Barcelona, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}]",Clinical transplantation,['10.1111/ctr.13988']
1001,31424244,Randomized clinical trial of exercise for nontreatment seeking adults with alcohol use disorder.,"The vast majority of individuals with alcohol use disorder (AUD) do not seek professional help despite its significant consequences upon the individual and society. Current interventions for nontreatment seeking individuals with AUD (e.g., screening, brief intervention, and referral to treatment [SBIRT]) have limited efficacy and alternative nonstigmatizing approaches are needed. This randomized clinical trial examined the utility of exercise as an intervention for sedentary nontreatment seeking adults with AUD. Participants ( N  = 66) were randomized to receive (a) a 4-month YMCA gym membership only (MO) or (b) a 4-month YMCA gym membership plus a 16-week integrated motivational intervention for exercise consisting of motivational interviewing and contingency management (MI + CM). Participants in both study conditions significantly increased their exercise behavior compared to baseline, and the MI + CM participants exercised significantly more often and an overall larger volume of exercise than the MO participants ( d s > 2.0). Significant reductions in drinking and alcohol-related consequences were noted over time but did not differ significantly by study condition and were not related to changes in exercise. Future interventions using exercise as an intervention for AUD may want to frame this type of intervention as ""wellness,"" directly link the 2 behaviors, and compare this intervention to SBIRT. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,Significant reductions in drinking and alcohol-related consequences were noted over time but did not differ significantly by study condition and were not related to changes in exercise.,"['sedentary nontreatment seeking adults with AUD', 'nontreatment seeking adults with alcohol use disorder', 'Participants ( N  = 66', 'individuals with alcohol use disorder (AUD']","['exercise', 'YMCA gym membership only (MO) or (b) a 4-month YMCA gym membership plus a 16-week integrated motivational intervention for exercise consisting of motivational interviewing and contingency management (MI + CM']","['drinking and alcohol-related consequences', 'exercise behavior', 'overall larger volume of exercise']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}]","[{'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",2019.0,0.0407427,Significant reductions in drinking and alcohol-related consequences were noted over time but did not differ significantly by study condition and were not related to changes in exercise.,"[{'ForeName': 'Jeremiah', 'Initials': 'J', 'LastName': 'Weinstock', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Petry', 'Affiliation': 'Department of Medicine, University of Connecticut.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Pescatello', 'Affiliation': 'Department of Kinesiology.'}, {'ForeName': 'Craig E', 'Initials': 'CE', 'LastName': 'Henderson', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Casey R', 'Initials': 'CR', 'LastName': 'Nelson', 'Affiliation': 'Department of Psychology.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000506']
1002,31375606,"Prevention of relapses with levamisole as adjuvant therapy in children with a first episode of idiopathic nephrotic syndrome: study protocol for a double blind, randomised placebo-controlled trial (the LEARNS study).","INTRODUCTION


Idiopathic nephrotic syndrome (INS) is characterised by a high relapse rate up to 80% after initial response to standard therapy with corticosteroids. Steroid toxicity is common and causes a great burden of disease that negatively influences the health-related quality of life (HRQoL). Recently, studies have shown that levamisole, an anthelminthic drug, significantly improves relapse-free survival in children with frequent relapses or steroid dependency. Compared with other steroid-sparing drugs, levamisole has relatively few side effects. We hypothesise that adding levamisole to standard therapy with corticosteroids in children with a first episode of INS will prevent relapses, decrease cumulative dosage of steroids used and improve HRQoL. This paper presents the study protocol for the LEARNS study (LEvamisole as Adjuvant therapy to Reduce relapses of Nephrotic Syndrome).
METHODS AND ANALYSIS


An international, double-blind, placebo-controlled randomised trial will be conducted in 20 participating hospitals in the Netherlands and Belgium. Participants (n=92) with a first episode of INS, aged 2-16 years, who achieve remission after 4 weeks of oral prednisolone will be randomly assigned (1:1) to receive either levamisole 2.5 mg/kg alternate day or placebo added to prednisolone (18-week tapering schedule) for a total of 24 weeks. Follow-up will be until 2 years after first presentation. Additionally, parents and/or children will fill out five HRQoL questionnaires. Primary outcome of the LEARNS study is occurrence of relapses within 12 months after first presentation. Secondary outcomes include time to first relapse, cumulative steroid dose after 2 years, safety parameters and quality of life scores.
ETHICS AND DISSEMINATION


The trial was approved by the Medical Ethical Committee. Results of the study will be published in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


NL6826, 2017-001025-41.",2019,Steroid toxicity is common and causes a great burden of disease that negatively influences the health-related quality of life (HRQoL).,"['children with a first episode of INS', 'children with a first episode of idiopathic nephrotic syndrome', '20 participating hospitals in the Netherlands and Belgium', 'Participants (n=92) with a first episode of INS, aged 2-16 years, who achieve remission after 4 weeks of oral', 'children with frequent relapses or steroid dependency']","['levamisole 2.5\u2009mg/kg alternate day or placebo added to prednisolone', 'placebo', 'prednisolone', 'levamisole']","['relapse-free survival', 'time to first relapse, cumulative steroid dose after 2 years, safety parameters and quality of life scores', 'occurrence of relapses', 'cumulative dosage of steroids used and improve HRQoL']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C3496337', 'cui_str': 'Nephrotic Syndrome, Type 2'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0011546', 'cui_str': 'Dependency'}]","[{'cui': 'C0023556', 'cui_str': 'Levamisole'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0558287', 'cui_str': 'Alternate days (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",,0.447957,Steroid toxicity is common and causes a great burden of disease that negatively influences the health-related quality of life (HRQoL).,"[{'ForeName': 'Floor', 'Initials': 'F', 'LastName': 'Veltkamp', 'Affiliation': 'Paediatric Nephrology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Djera H', 'Initials': 'DH', 'LastName': 'Khan', 'Affiliation': 'Pathology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Reefman', 'Affiliation': 'Paediatric Nephrology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Veissi', 'Affiliation': 'Paediatric Nephrology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Hedy A', 'Initials': 'HA', 'LastName': 'van Oers', 'Affiliation': 'Psychosocial Department, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Levtchenko', 'Affiliation': 'Paediatric Nephrology, Universitaire Ziekenhuizen Leuven, Leuven, Belgium.'}, {'ForeName': 'Ron A A', 'Initials': 'RAA', 'LastName': 'Mathôt', 'Affiliation': 'Hospital Pharmacy, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Florquin', 'Affiliation': 'Pathology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Joanna A E', 'Initials': 'JAE', 'LastName': 'van Wijk', 'Affiliation': 'Paediatric Nephrology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Michiel F', 'Initials': 'MF', 'LastName': 'Schreuder', 'Affiliation': 'Paediatric Nephrology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Haverman', 'Affiliation': 'Psychosocial Department, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Antonia H M', 'Initials': 'AHM', 'LastName': 'Bouts', 'Affiliation': 'Paediatric Nephrology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2018-027011']
1003,31801563,"A double-masked placebo-controlled trial of azithromycin to prevent child mortality in Burkina Faso, West Africa: Community Health with Azithromycin Trial (CHAT) study protocol.","BACKGROUND


Biannual, mass azithromycin distribution has previously been shown to reduce all-cause child mortality in sub-Saharan Africa. Subgroup analysis suggested that the strongest effects were in the youngest children, leading to the hypothesis that targeting younger age groups might be an effective strategy to prevent mortality. We present the methods of two randomized controlled trials designed to evaluate mass and targeted azithromycin distribution for the prevention of child mortality in Burkina Faso, West Africa.
METHODS/DESIGN


The Child Health with Azithromycin Treatment (CHAT) study consists of two nested, randomized controlled trials. In the first, communities are randomized in a 1:1 fashion to biannual, mass azithromycin distribution or placebo. The primary outcome is under-5 all-cause mortality measured at the community level. In the second, children attending primary healthcare facilities during the first 5-12 weeks of life for a healthy child visit (e.g., for vaccination) are randomized in a 1:1 fashion to a single orally administered dose of azithromycin or placebo. The primary outcome is all-cause mortality measured at 6 months of age. The trial commenced enrollment in August 2019.
DISCUSSION


This study is expected to provide evidence on two health systems delivery approaches (mass and targeted treatment) for azithromycin to prevent all-cause child mortality. The results will inform global and national policies related to azithromycin for the prevention of child mortality.
TRIAL REGISTRATION


ClinicalTrials.gov, ID: NCT03676764. Registered on 19 September 2018; prospectively registered pre results.",2019,"Subgroup analysis suggested that the strongest effects were in the youngest children, leading to the hypothesis that targeting younger age groups might be an effective strategy to prevent mortality.","['child mortality in Burkina Faso, West Africa', 'children attending primary healthcare facilities during the first 5-12\u2009weeks of life for a healthy child visit (e.g., for vaccination']","['placebo', 'azithromycin', 'Azithromycin', 'azithromycin distribution or placebo', 'azithromycin or placebo']","['cause mortality', 'under-5 all-cause mortality']","[{'cui': 'C0008083', 'cui_str': 'Child Mortality'}, {'cui': 'C0006409', 'cui_str': 'Upper Volta'}, {'cui': 'C0001747', 'cui_str': 'West Africa'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.55982,"Subgroup analysis suggested that the strongest effects were in the youngest children, leading to the hypothesis that targeting younger age groups might be an effective strategy to prevent mortality.","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sié', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Mamadou', 'Initials': 'M', 'LastName': 'Ouattara', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Mamadou', 'Initials': 'M', 'LastName': 'Bountogo', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Cheik', 'Initials': 'C', 'LastName': 'Bagagnan', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Boubacar', 'Initials': 'B', 'LastName': 'Coulibaly', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Boudo', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lebas', 'Affiliation': 'Francis I. Proctor Foundation, University of California, 513 Parnassus Ave, Room S334, San Francisco, CA, USA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Brogdon', 'Affiliation': 'Francis I. Proctor Foundation, University of California, 513 Parnassus Ave, Room S334, San Francisco, CA, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Francis I. Proctor Foundation, University of California, 513 Parnassus Ave, Room S334, San Francisco, CA, USA.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Heidelberg, Germany.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I. Proctor Foundation, University of California, 513 Parnassus Ave, Room S334, San Francisco, CA, USA.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Doan', 'Affiliation': 'Francis I. Proctor Foundation, University of California, 513 Parnassus Ave, Room S334, San Francisco, CA, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I. Proctor Foundation, University of California, 513 Parnassus Ave, Room S334, San Francisco, CA, USA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Francis I. Proctor Foundation, University of California, 513 Parnassus Ave, Room S334, San Francisco, CA, USA. catherine.oldenburg@ucsf.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-3855-9']
1004,32688225,Gender and racial/ethnic differences in physiologic responses in the Stimulant Reduction Intervention using Dosed Exercise Study.,"Exercise may be beneficial for individuals in substance use disorder (SUD) treatment given the higher rates of both medical and psychiatric comorbidity, namely mood and anxiety disorders, compared to the general population. Gender and/or racial/ethnic differences in health benefits and response to prescribed exercise have been reported and may have implications for designing exercise interventions in SUD programs.
METHOD


Data are from the National Drug Abuse Treatment Clinical Trials Network (NIDA/CTN) Stimulant Reduction Intervention using Dosed Exercise (STRIDE) trial. Gender differences across racial/ethnic groups in physiological responses and stimulant withdrawal severity across time were analyzed using linear mixed effects models.
RESULTS


Males completed significantly more exercise sessions than females and were more adherent to the prescribed exercise dose of 12 Kcal/Kg/Week. Controlling for age, race/ethnicity, treatment group and stimulant withdrawal severity, there was a significant gender by time interaction for body mass index (BMI) (p < 0.001), waist circumference (p < 0.001) and heart rate measured prior to exercise sessions (p < 0.01). For females, body mass index (BMI) and waist circumference increased over time while for males BMI and waist circumference stayed unchanged or slightly decreased with time. Heart rate over time significantly increased for females at a higher rate than in males. Stimulant withdrawal severity was similar in males and females at baseline but males exhibited a significant decrease over time while females did not. Although baseline differences were observed, there were no time by race/ethnicity differences in physiologic responses.
DISCUSSION


Gender differences in response to exercise may have implications for developing gender specific exercise interventions in SUD programs.",2020,Stimulant withdrawal severity was similar in males and females at baseline but males exhibited a significant decrease over time while females did not.,['Data are from the National Drug Abuse Treatment Clinical Trials Network (NIDA/CTN'],['Stimulant Reduction Intervention'],"['waist circumference', 'heart rate', 'time interaction for body mass index (BMI', 'Heart rate over time', 'Stimulant withdrawal severity', 'body mass index (BMI) and waist circumference', 'exercise sessions']","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0013146', 'cui_str': 'Drug abuse'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1997739', 'cui_str': 'Psychostimulant withdrawal'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0431347,Stimulant withdrawal severity was similar in males and females at baseline but males exhibited a significant decrease over time while females did not.,"[{'ForeName': 'T K', 'Initials': 'TK', 'LastName': 'Killeen', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA. Electronic address: killeent@musc.edu.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Wolf', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Greer', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Carmody', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Rethorst', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106546']
1005,31418163,Effects of transverse maxillomandibular distraction osteogenesis on obstructive sleep apnea syndrome and on the pharynx.,"PURPOSE


To assess the effects of transverse maxillomandibular distraction osteogenesis (TMDO) on the treatment of obstructive sleep apnea (OSA) and on the morphology of the pharynx.
METHODS


A clinical trial was conducted with seven patients with OSA and with transverse maxillomandibular deficiency, two women and five men aged on average 41.16 ± 10.9 years on the day of surgery. All participants were submitted to computed tomography (CT) and full-night polysomnography (PSG) before and approximately 9 months after surgery. A 95% confidence interval was defined.
RESULTS


The AHI and RDI of the participants were reduced by about 62% (from 27.65 ± 36.65 to 10.73 ± 11.78, p = 0.031 and from 41.21 ± 32.73 to 15.30 ± 13.87, p = 0.015, respectively). The airway showed a surprising mean reduction in volume of 10% (from 5.78 ± 2.53 to 4.71 ± 1.42, p = 0.437, for the upper pharynx; from 6.98 ± 2.23 to 6.23 ± 2.05, p = 0.437, for the lower pharynx; and from 12.76 ± 1.56 to 10.94 ± 2.42, p = 0.625, for the total pharynx). However, the site of the smallest area of the pharynx was considerably increased both in the anteroposterior and transverse direction and in its total area (from 0.88 ± 7.11 to 0.99 ± 0.39, p = 0.625; from 1.78 ± 0.81 to 2.05 ± 0.61, p = 0.812; and from 0.99 ± 0.74 to 1.40 ± 0.51, p = 0.180, respectively).
CONCLUSION


TMDO proved to be efficient in reducing or curing OSA, producing modifications of upper pharynx morphology with an increase of the smallest area of the pharynx.",2020,"The airway showed a surprising mean reduction in volume of 10% (from 5.78 ± 2.53 to 4.71 ± 1.42, p = 0.437, for the upper pharynx; from 6.98 ± 2.23 to 6.23 ± 2.05, p = 0.437, for the lower pharynx; and from 12.76 ± 1.56 to 10.94 ± 2.42, p = 0.625, for the total pharynx).","['seven patients with OSA and with transverse maxillomandibular deficiency, two women and five men aged on average 41.16\u2009±\u200910.9\xa0years on the day of surgery']","['TMDO', 'computed tomography (CT) and full-night polysomnography (PSG', 'transverse maxillomandibular distraction osteogenesis (TMDO', 'transverse maxillomandibular distraction osteogenesis']","['obstructive sleep apnea (OSA', 'AHI and RDI', 'obstructive sleep apnea syndrome']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0446380', 'cui_str': 'Transverse (qualifier value)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0058721', 'cui_str': 'TMDO'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0446380', 'cui_str': 'Transverse (qualifier value)'}, {'cui': 'C0524975', 'cui_str': 'Osteogenesis, Distraction'}]","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]",,0.0290673,"The airway showed a surprising mean reduction in volume of 10% (from 5.78 ± 2.53 to 4.71 ± 1.42, p = 0.437, for the upper pharynx; from 6.98 ± 2.23 to 6.23 ± 2.05, p = 0.437, for the lower pharynx; and from 12.76 ± 1.56 to 10.94 ± 2.42, p = 0.625, for the total pharynx).","[{'ForeName': 'Pedro Pileggi', 'Initials': 'PP', 'LastName': 'Vinha', 'Affiliation': 'Department of Ophthalmology, Otorhinolaryngology and Head and Neck Surgery, Faculty of Medicine of Ribeirão Preto, University of São Paulo, Av. Bandeirantes, 3900, Ribeirão Preto, SP, 14049-900, Brazil. pvinha@usp.br.'}, {'ForeName': 'Ana Célia', 'Initials': 'AC', 'LastName': 'Faria', 'Affiliation': 'Department of Ophthalmology, Otorhinolaryngology and Head and Neck Surgery, Faculty of Medicine of Ribeirão Preto, University of São Paulo, Av. Bandeirantes, 3900, Ribeirão Preto, SP, 14049-900, Brazil.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Christino', 'Affiliation': 'Department of Ophthalmology, Otorhinolaryngology and Head and Neck Surgery, Faculty of Medicine of Ribeirão Preto, University of São Paulo, Av. Bandeirantes, 3900, Ribeirão Preto, SP, 14049-900, Brazil.'}, {'ForeName': 'Francisco Veríssimo', 'Initials': 'FV', 'LastName': 'de Mello-Filho', 'Affiliation': 'Department of Ophthalmology, Otorhinolaryngology and Head and Neck Surgery, Faculty of Medicine of Ribeirão Preto, University of São Paulo, Av. Bandeirantes, 3900, Ribeirão Preto, SP, 14049-900, Brazil.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-019-01916-1']
1006,31413313,A monocentric study of steroid-refractory acute graft-versus-host disease treatment with tacrolimus and mTOR inhibitor.,"Acute graft-versus-host disease (aGVHD) remains one of the leading causes of morbidity and mortality after allogeneic hematopoietic stem cell transplantation. No consensus exists on the best second-line treatment of steroid-refractory acute GVHD (SR-aGVHD). Previously published smaller studies on the use of sirolimus in SR-aGVHD treatment report a response rate of 57 to 86%, with 40% overall survival. The association of tacrolimus and mTOR inhibitor is supported by pre-clinical data and has been used as GVHD prophylaxis. We report 42 patients who received tacrolimus and mTOR inhibitor as a second- or third-line treatment of SR-aGVHD. Thirty-one patients were treated in second-line, with an overall response rate of 48.5% (complete response: 42%). Eleven patients were treated in third-line, with an overall response rate of 27%. Thirty-eight patients had at least one episode of infection, due to bacteria, viruses, fungi and parasites in 61, 42, 12 and two episodes, respectively. For patients treated in second-line, six-month and one-year survival were 61% and 42%, respectively. None of the patients treated in third-line survived. These results were not promising enough to initiate a phase three randomized clinical trial, but tacrolimus and mTOR inhibitor can be discussed among other options for patients with SR-aGVHD.",2020,"For patients treated in second-line, six-month and one-year survival were 61% and 42%, respectively.","['42 patients who received', 'patients with SR-aGVHD', 'allogeneic hematopoietic stem cell transplantation']","['tacrolimus and mTOR inhibitor as a second- or third-line treatment of SR-aGVHD', 'tacrolimus and mTOR inhibitor']","['response rate', 'year survival', 'overall response rate', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C2986605', 'cui_str': 'Third line treatment'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",42.0,0.0304372,"For patients treated in second-line, six-month and one-year survival were 61% and 42%, respectively.","[{'ForeName': 'Alienor', 'Initials': 'A', 'LastName': 'Xhaard', 'Affiliation': ""Service d'hématologie-greffe, Hôpital Saint-Louis, Université Paris Diderot, Paris, France. alienor.xhaard@aphp.fr.""}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Launay', 'Affiliation': 'Service de pharmacologie, Hôpital Européen Georges-Pompidou, Paris, France.'}, {'ForeName': 'Flore', 'Initials': 'F', 'LastName': 'Sicre de Fontbrune', 'Affiliation': ""Service d'hématologie-greffe, Hôpital Saint-Louis, Université Paris Diderot, Paris, France.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Michonneau', 'Affiliation': ""Service d'hématologie-greffe, Hôpital Saint-Louis, Université Paris Diderot, Paris, France.""}, {'ForeName': 'Aurelien', 'Initials': 'A', 'LastName': 'Sutra Del Galy', 'Affiliation': ""Service d'hématologie-greffe, Hôpital Saint-Louis, Université Paris Diderot, Paris, France.""}, {'ForeName': 'Tereza', 'Initials': 'T', 'LastName': 'Coman', 'Affiliation': ""Service d'hématologie-greffe, Hôpital Saint-Louis, Université Paris Diderot, Paris, France.""}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Pagliuca', 'Affiliation': ""Service d'hématologie-greffe, Hôpital Saint-Louis, Université Paris Diderot, Paris, France.""}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Dhedin', 'Affiliation': ""Service d'hématologie adolescents-jeunes adultes, Hôpital Saint-Louis, Université Paris Diderot, Paris, France.""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Robin', 'Affiliation': ""Service d'hématologie-greffe, Hôpital Saint-Louis, Université Paris Diderot, Paris, France.""}, {'ForeName': 'Regis', 'Initials': 'R', 'LastName': 'Peffault de Latour', 'Affiliation': ""Service d'hématologie-greffe, Hôpital Saint-Louis, Université Paris Diderot, Paris, France.""}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Socie', 'Affiliation': ""Service d'hématologie-greffe, Hôpital Saint-Louis, Université Paris Diderot, Paris, France.""}]",Bone marrow transplantation,['10.1038/s41409-019-0633-y']
1007,31411351,Effect of different fraction of inspired oxygen on development of atelectasis in mechanically ventilated children: A randomized controlled trial.,"BACKGROUND


The use of high fraction of inspired oxygen (F I  O 2  ) can cause direct pulmonary toxicity and pulmonary complications. The purpose of this study was to evaluate the effect of different F I  O 2  on development of intraoperative atelectasis in mechanically ventilated children using lung ultrasound.
METHODS


In this randomized controlled, patient- and sonographer-blinded trial, 86 children (≤6 years) undergoing noncardiac surgery were allocated into a low (n = 43) or high (n = 43) F I  O 2  group. The low F I  O 2  group consistently received 30% air-oxygen mixture during preoxygenation, ultrasound-guided recruitment maneuver, and mechanical ventilation. The high F I  O 2  group received 100% oxygen during preoxygenation and ultrasound-guided recruitment maneuver and 60% air-oxygen mixture during mechanical ventilation. Positive end-expiratory pressure of 5 cm H 2  O was applied in both groups. Lung ultrasound was performed one minute after the start of mechanical ventilation and at the end of surgery in both groups. Primary outcome was significant atelectasis incidence (consolidation score of ≥2 in any region) on the postoperative lung ultrasound. Secondary outcomes included significant atelectasis incidence on the preoperative lung ultrasound, incidences of intra- and postoperative desaturation, and incidences of postoperative fever and postoperative pulmonary complications.
RESULTS


Significant atelectasis incidence on the postoperative lung ultrasound was similar between the low and high F I  O 2  groups (28% vs 37%; Pearson chi-square value = 0.847; P = .357; OR 1.531; 95% CI 0.617-3.800). Significant atelectasis incidence on the preoperative lung ultrasound was also similar between the groups (12% vs 9%; Pearson chi-square value = 0.124; P = .725; OR 0.779; 95% CI 0.194-3.125). There were no statistically significant differences in the other secondary outcomes.
CONCLUSIONS


F I  O 2  did not affect significant atelectasis formation in mechanically ventilated children who received ultrasound-guided recruitment maneuver and positive end-expiratory pressure.",2019,F I  O 2  did not affect significant atelectasis formation in mechanically ventilated children who received ultrasound-guided recruitment maneuver and positive end-expiratory pressure.,"['mechanically ventilated children', 'mechanically ventilated children using lung ultrasound', '86 children (≤6\xa0years) undergoing noncardiac surgery were allocated into a low (n\xa0=\xa043) or high (n\xa0=\xa043']","['30% air-oxygen mixture during preoxygenation, ultrasound-guided recruitment maneuver, and mechanical ventilation', 'F I  O 2', 'fraction of inspired oxygen', '100% oxygen during preoxygenation and ultrasound-guided recruitment maneuver and 60% air-oxygen mixture during mechanical ventilation']","['atelectasis formation', 'significant atelectasis incidence on the preoperative lung ultrasound, incidences of intra- and postoperative desaturation, and incidences of postoperative fever and postoperative pulmonary complications', 'atelectasis incidence (consolidation score of ≥2 in any region) on the postoperative lung ultrasound', 'Positive end-expiratory pressure', 'preoperative lung ultrasound', 'postoperative lung ultrasound']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0412792', 'cui_str': 'Preoxygenation (procedure)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0004144', 'cui_str': 'Lung Collapse'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0424786', 'cui_str': 'Postoperative fever (finding)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}]",86.0,0.180537,F I  O 2  did not affect significant atelectasis formation in mechanically ventilated children who received ultrasound-guided recruitment maneuver and positive end-expiratory pressure.,"[{'ForeName': 'In-Kyung', 'Initials': 'IK', 'LastName': 'Song', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young-Eun', 'Initials': 'YE', 'LastName': 'Jang', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Eun-Hee', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Seokha', 'Initials': 'S', 'LastName': 'Yoo', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Hee-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin-Tae', 'Initials': 'JT', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Seoul National University College of Medicine, Seoul, Korea.'}]",Paediatric anaesthesia,['10.1111/pan.13718']
1008,32140784,Eldecalcitol is superior to alfacalcidol in maintaining bone mineral density in glucocorticoid-induced osteoporosis patients (e-GLORIA).,"INTRODUCTION


Eldecalcitol increases bone mineral density (BMD) and reduces vertebral fracture in patients with primary osteoporosis. However, the effect of eldecalcitol on BMD and fracture in glucocorticoid-induced osteoporosis (GIO) patients is unknown. This study was undertaken to compare the effect of eldecalcitol on BMD and fracture with that of alfacalcidol in GIO patients.
MATERIALS AND METHODS


A randomized, open-label, parallel group study was conducted to identify the effectiveness and safety of monotherapy with 0.75 μg eldecalcitol compared with 1.0 μg alfacalcidol in GIO patients.
RESULTS


Lumbar spine BMD increased with eldecalcitol, but decreased with alfacalcidol at 12 and 24 months (between group difference 1.29%, p < 0.01, and 1.10%, p < 0.05, respectively). Total hip and femoral neck BMD were maintained until 24 months by eldecalcitol, but decreased by alfacalcidol (between group difference 0.97%, p < 0.05 and 1.22%, p < 0.05, respectively). Both bone formation and resorption markers were more strongly suppressed by eldecalcitol than by alfacalcidol. Eldecalcitol showed better effect on BMD than alfacalcidol in patients with no prevalent fracture and BMD > 70% of the young adult mean, and with ≤ 3 months of previous glucocorticoid treatment. No significant difference in the incidence of vertebral fracture was found, and the incidence of adverse events was similar between the two groups.
CONCLUSIONS


Eldecalcitol was more effective than alfacalcidol in maintaining BMD in GIO patients. Because eldecalcitol was effective in patients with no or short-term previous glucocorticoid treatment, as well as those without prevalent fracture or low BMD, eldecalcitol can be a good candidate for primary prevention of GIO.
CLINICAL TRIAL REGISTRATION NUMBER


UMIN000011700.",2020,"No significant difference in the incidence of vertebral fracture was found, and the incidence of adverse events was similar between the two groups.
","['GIO patients', 'patients with primary osteoporosis']","['monotherapy', 'Eldecalcitol', 'eldecalcitol']","['bone mineral density', 'incidence of adverse events', 'incidence of vertebral fracture', 'bone mineral density (BMD', 'effectiveness and safety', 'vertebral fracture', 'BMD', 'bone formation and resorption markers', 'Lumbar spine BMD', 'Total hip and femoral neck BMD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0410438', 'cui_str': 'Primary osteoporosis (disorder)'}]","[{'cui': 'C2828245', 'cui_str': '2-(3-hydroxypropoxy)calcitriol'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}]",,0.0374739,"No significant difference in the incidence of vertebral fracture was found, and the incidence of adverse events was similar between the two groups.
","[{'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Fujii Memorial Institute of Medical Sciences, Tokushima University, Tokushima, 770-8530, Japan. toshio.matsumoto@tokushima-u.ac.jp.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Laboratory for Autoimmune Diseases, RIKEN Center for Integrative Medical Sciences, Yokohama, Kanagawa, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan.'}, {'ForeName': 'Sakae', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Orthopaedic Surgery, The University of Tokyo Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Nakano', 'Affiliation': 'Tamana Central Hospital, Tamana, Kumamoto, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Ito', 'Affiliation': 'The Open University of Japan, Nagasaki, Nagasaki, Japan.'}, {'ForeName': 'Tatsushi', 'Initials': 'T', 'LastName': 'Tomomitsu', 'Affiliation': 'Department of Radiology, Kawasaki Medical School, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Hirakawa', 'Affiliation': 'Department of Biostatistics and Bioinformatics, The University of Tokyo Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Soen', 'Affiliation': 'Department of Orthopaedic Surgery and Rheumatology, Kindai University Nara Hospital, Ikoma, Nara, Japan.'}]",Journal of bone and mineral metabolism,['10.1007/s00774-020-01091-4']
1009,32062040,No Association Between Vitamin D Supplementation and Risk of Colorectal Adenomas or Serrated Polyps in a Randomized Trial.,"BACKGROUND & AIMS


The effects of vitamin D on risk of colorectal cancer precursors are not clear. We examined the influence of vitamin D supplementation on risk of colorectal adenomas and serrated polyps in a prespecified ancillary study of a large-scale prevention trial (the vitamin D and omegA-3 trial, VITAL) of individuals who were free of cancer and cardiovascular disease at enrollment.
METHODS


In VITAL trial, 25,871 adults with no history of cancer or cardiovascular disease (12,786 men 50 years or older and 13,085 women 55 years or older) were randomly assigned to groups given daily dietary supplements (2000 IU vitamin D 3  and 1 g marine n-3 fatty acid) or placebo. Patients were assigned to groups from November 2011 through March 2014 and the study ended on December 31, 2017. We confirmed conventional adenomas and serrated polyps by reviewing histopathology reports from participants who had reported a diagnosis of polyps and were asked by their doctors to return for a repeat colonoscopy or sigmoidoscopy in 5 years or less. We calculated the odds ratios (ORs) and 95% CIs by logistic regression, after adjusting for age, sex, n-3 treatment assignment, and history of endoscopy at time of randomization.
RESULTS


During a median follow-up of 5.3 years, we documented 308 cases of conventional adenomas in 12,927 participants in the vitamin D group and 287 cases in 12,944 participants in the placebo group (OR for the association of vitamin D supplementation with adenoma, 1.08; 95% CI, 0.92-1.27). There were 172 cases of serrated polyps in the vitamin D group and 169 cases in the placebo group (OR for the association of vitamin D supplementation with serrated polyp, 1.02; 95% CI, 0.82-1.26). Supplementation was not associated with polyp size, location, multiplicity, or histologic features. We found evidence for an interaction between vitamin D supplementation and serum level of 25-hydroxyvitamin D, measured in 15,787 participants. Among individuals with serum levels of 25-hydroxyvitamin D below 30 ng/mL, the OR associated with supplementation for conventional adenoma was 0.82 (95% CI, 0.60-1.13), whereas among individuals with serum levels of 25-hydroxyvitamin D above 30 ng/mL, the OR for conventional adenoma was 1.20 (95% CI, 0.92-1.55) (P for interaction = .07). There was a significant interaction between vitamin D supplementation and serum level of 25-hydroxyvitamin D in their association with advanced adenoma (P for interaction = .04).
CONCLUSIONS


Based on an ancillary study of data from the VITAL trial, daily vitamin D supplementation (2000 IU) was not associated with risk of colorectal cancer precursors in average-risk adults not selected for vitamin D insufficiency. A potential benefit for individuals with low baseline level of vitamin D requires further investigation. ClinicalTrials.gov number: NCT01169259.",2020,"Supplementation was not associated with polyp size, location, multiplicity, or histologic features.","['15,787 participants', '25,871 adults with no history of cancer or cardiovascular disease (12,786 men 50 y or older and 13,085 women 55 y or older', 'Patients were assigned to groups from November 2011 through March 2014 and the study ended on December 31, 2017', 'individuals with low baseline level of vitamin D', 'participants who had reported a diagnosis of polyps and were asked by their doctors to return for a repeated endoscopy in 5 years or less', 'individuals who were free of cancer and cardiovascular disease at enrollment']","['vitamin D supplementation', 'placebo', 'daily dietary supplements (2000 IU vitamin D 3  and 1 g marine n-3 fatty acid) or placebo', 'Vitamin D Supplementation', 'vitamin D']","['serum level of 25-hydroxyvitamin D', 'polyp size, location, multiplicity, or histologic features', 'risk of colorectal adenomas and serrated polyps', 'vitamin D supplementation and serum level of 25-hydroxyvitamin D', 'serum levels of 25-hydroxyvitamin D']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C1299212', 'cui_str': 'Polyp size'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0449822', 'cui_str': 'Multiplicity (attribute)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C3266123', 'cui_str': 'Serrated polyp (morphologic abnormality)'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]",25871.0,0.571433,"Supplementation was not associated with polyp size, location, multiplicity, or histologic features.","[{'ForeName': 'Mingyang', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Clinical and Translational Epidemiology Unit, Mongan Institute, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts; Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts. Electronic address: mingyangsong@mail.harvard.edu.'}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': ""Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts; Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Rimma', 'Initials': 'R', 'LastName': 'Dushkes', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gordon', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Walter', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Wu', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Chan', 'Affiliation': ""Clinical and Translational Epidemiology Unit, Mongan Institute, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts; Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts; Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts; Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Broad Institute of Massachusetts Institute of Technology and Harvard, Cambridge, Massachusetts.""}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Ogino', 'Affiliation': ""Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Broad Institute of Massachusetts Institute of Technology and Harvard, Cambridge, Massachusetts; Department of Oncologic Pathology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts; Program in MPE Molecular Pathological Epidemiology, Department of Pathology, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': 'Yale Cancer Center, New Haven, Connecticut; Department of Medicine, Yale School of Medicine, New Haven, Connecticut; Smilow Cancer Hospital, New Haven, Connecticut.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Meyerhardt', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Giovannucci', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Department of Medicine, Yale School of Medicine, New Haven, Connecticut.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.02.013']
1010,32496600,Can a participatory organizational intervention improve social capital and organizational readiness to change? Cluster randomized controlled trial at five Danish hospitals.,"AIM


This study investigates the effect of a participatory organizational intervention on social capital and organizational readiness for change.
DESIGN


Cluster randomized controlled trial.
METHODS


In 2016, 27 departments from five hospitals in Denmark were randomly allocated at the department level to 1 year of participatory intervention (14 clusters, 316 healthcare workers) or a control group (13 clusters, 309 healthcare workers). The participatory intervention consisted of 2 × 2 hr workshops, where managers, 2-5 healthcare workers from each department, and the hospital's health and safety staff, developed action plans for implementing solutions for improving the use of assistive devices at the department throughout the 1-year intervention period. Workplace social capital: (a) within teams (bonding); (b) between teams and nearest leaders (linking A); and (c) between teams and distant leaders (linking B) and organizational readiness for change were measured using questionnaires at baseline, 6, and 12 months.
RESULTS


No group-by-time interaction occurred for any of the outcome measures. However, explorative post hoc analysis showed within-group improvements in bonding and linking B social capital and organizational readiness for change following the participatory intervention.
CONCLUSION


Participatory organizational interventions may improve social capital within teams and between teams and distant leaders and organizational readiness for change.
IMPACT


Implementing participatory interventions at the workplace may be a cost-effective strategy as they provide additional benefits, e.g., increased social capital and improved organizational readiness for change, that exceed the primary outcome of the intervention.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT02708550) March 2016.",2020,No group by time interaction occurred for any of the outcome measures.,"['In 2016, twenty-seven departments from five hospitals in Denmark were randomly allocated at the department level to one year of participatory intervention (14 clusters, 316 healthcare workers) or a control group (13 clusters, 309 healthcare workers']","['Participatory organizational interventions', 'participatory organizational intervention']","['social capital and organizational readiness', 'time interaction', 'bonding and linking B social capital and Organizational readiness']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0029246', 'cui_str': 'Organizations'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1510639', 'cui_str': 'Social Capital'}, {'cui': 'C0029246', 'cui_str': 'Organizations'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]",,0.0589774,No group by time interaction occurred for any of the outcome measures.,"[{'ForeName': 'Markus Due', 'Initials': 'MD', 'LastName': 'Jakobsen', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Clausen', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Lars Louis', 'Initials': 'LL', 'LastName': 'Andersen', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}]",Journal of advanced nursing,['10.1111/jan.14441']
1011,31409183,Electroacupuncture Modulates Resting-State Functional Connectivity in the Default Mode Network for Healthy Older Adults.,"Aging involves cognitive decline and prominent alterations in brain activity. Electroacupuncture (EA), a traditional Chinese medicine approach, is demonstrated to be effective in improving cognitive function of older adults. However, the specific neural mechanism underlying this modulation effect remains unclear. In this study, we used functional magnetic resonance imaging (fMRI) to investigate whether EA could improve cognitive performance of community-dwelling older adults and whether these potential improvements are associated with the EA-induced brain functional connectivity alterations. Thirty healthy older adults were recruited and randomly assigned to the EA group and the control group. Behaviorally, we observed an EA-induced improvement in cognitive performance of older adults in the Montreal Cognitive Assessment. On a neural perspective, the EA intervention significantly increased the functional connectivity within the default mode network. Moreover, we found a positive association between the improvement in delayed memory performance and the alterations in the ventral medial prefrontal cortex-hippocampal formation connectivity in the EA group. This study extends previous findings by showing that healthy older adults exhibit neural plasticity manifested as increased functional connectivity after EA sessions, which could induce therapeutic effects in the treatment of neurodegenerative diseases.",2020,"Moreover, we found a positive association between the improvement in delayed memory performance and the alterations in the ventral medial prefrontal cortex-hippocampal formation connectivity in the EA group.","['community-dwelling older adults', 'Thirty healthy older adults', 'healthy older adults', 'Healthy Older Adults', 'older adults']","['Electroacupuncture', 'Electroacupuncture (EA', 'functional magnetic resonance imaging (fMRI', 'EA']","['delayed memory performance', 'functional connectivity', 'cognitive performance', 'ventral medial prefrontal cortex-hippocampal formation connectivity']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0376364', 'cui_str': 'Delayed Memory'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C3850122', 'cui_str': 'Ventral Medial Prefrontal Cortex'}, {'cui': 'C0175202', 'cui_str': 'Hippocampal Formation'}]",30.0,0.0270251,"Moreover, we found a positive association between the improvement in delayed memory performance and the alterations in the ventral medial prefrontal cortex-hippocampal formation connectivity in the EA group.","[{'ForeName': 'Dong-Qiong', 'Initials': 'DQ', 'LastName': 'Fan', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing, China.'}, {'ForeName': 'Hai-Chao', 'Initials': 'HC', 'LastName': 'Zhao', 'Affiliation': 'School of Biological Science and Medical Engineering, Beihang University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Sheng', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing, China.'}, {'ForeName': 'Yun-Rui', 'Initials': 'YR', 'LastName': 'Liu', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing, China.'}]",Journal of geriatric psychiatry and neurology,['10.1177/0891988719868304']
1012,32054380,Benefits of a Dance Intervention on Balance in Adolescents with Cerebral Palsy.,"AIMS


Cerebral palsy (CP) impacts motor functions such as balance, limits of stability and walking, and may also affect other functions such as attention and rhythm production. Motor and non-motor deficits lead to difficulties in daily life activities. The main objective of this study was to evaluate the effects of a dance intervention on balance in adolescents with CP. The secondary objectives were to evaluate the effects of this intervention on walking speed, attention, and rhythm production.
METHODS


A pre-post design study with a double baseline was conducted on ten adolescents with CP in order to assess the effects of a 10-week dance intervention. The dance intervention focused on improving balance and limits of stability. Outcomes on static and dynamic balance were evaluated with clinical and laboratory tests before and after the intervention. Walking speed, attention, and rhythm production were also evaluated before and after the intervention.
RESULTS


Balance improved after the dance intervention as assessed with both the clinical tests and a laboratory test. Rhythm production also improved after the dance intervention.
CONCLUSIONS


Results suggest that a 10-week dance intervention is an effective activity to improve static and dynamic balance as well as rhythmic production in adolescents with CP.",2020,Rhythm production also improved after the dance intervention.,"['ten adolescents with CP', 'adolescents with CP', 'Adolescents with Cerebral Palsy']","['Dance Intervention', 'dance intervention']","['walking speed, attention, and rhythm production', 'balance and limits of stability', 'Rhythm production', 'static and dynamic balance', 'Walking speed, attention, and rhythm production']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}]","[{'cui': 'C0010963', 'cui_str': 'Dancing'}]","[{'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033268'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}]",10.0,0.0199103,Rhythm production also improved after the dance intervention.,"[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Cherriere', 'Affiliation': 'Centre de Réadaptation Marie Enfant, Centre de Recherche du CHU Sainte Justine, Montréal, Canada.'}, {'ForeName': 'Mélissa', 'Initials': 'M', 'LastName': 'Martel', 'Affiliation': 'Centre de Réadaptation Marie Enfant, Centre de Recherche du CHU Sainte Justine, Montréal, Canada.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Sarrasin', 'Affiliation': 'Centre de Réadaptation Marie Enfant, Centre de Recherche du CHU Sainte Justine, Montréal, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Ballaz', 'Affiliation': 'Centre de Réadaptation Marie Enfant, Centre de Recherche du CHU Sainte Justine, Montréal, Canada.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Tallet', 'Affiliation': 'ToNIC Toulouse NeuroImaging Center, Université de Toulouse, Inserm, UPS, Toulouse, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lemay', 'Affiliation': 'Centre de Réadaptation Marie Enfant, Centre de Recherche du CHU Sainte Justine, Montréal, Canada.'}]",Physical & occupational therapy in pediatrics,['10.1080/01942638.2020.1720053']
1013,32063157,Nebulised normal saline in moderate acute bronchiolitis and pneumonia in a low- to middle-income country: a randomised trial in Papua New Guinea.,"BACKGROUND


Acute lower respiratory tract infections are the commonest cause of hospitalisation in young children and supportive care remains the cornerstone of management. A randomised open trial was undertaken at the Port Moresby General Hospital Children's Emergency Department (CED) to determine whether nebulised normal saline had beneficial effects.
METHODS


Children <2 years of age presenting with a clinical diagnosis of moderate acute bronchiolitis or moderate pneumonia were randomised to receive standard care alone or with nebulised normal saline administered hourly. The outcomes were the difference in respiratory distress scores (RDS) and oxygen saturation between 0 and 4 hours, and admission rates.
RESULTS


A total of 199 patients participated; 100 patients were randomised to normal saline and 99 to standard care. At 4 hours there was a significant difference in the change of the respiratory distress scores: mean RDS reduced by 3.41 (95% CI 3.0-3.8) in the normal saline group, and for the standard group, the RDS reduced by 1.96 (95% CI 1.5-2.4,  p  < 0.0001). In those receiving normal saline oxygen saturation measured by pulse oximetry (SpO 2 ) increased by a mean of 7% (95% CI 6.0-7.9) to 90.7% at 4 hours. For those receiving standard care, the SpO 2  increased by a mean of 4% (95% CI 2.8-5.2) to 87.5% at 4 hours ( p  < 0.001). Of 100 patients, 58 (58%) in the normal saline group and 24 of 99 (24.2%) in the standard arm were discharged from the Children's Emergency Department ( p  < 0.001).
CONCLUSIONS


This study supports the use of nebulised normal saline in the treatment of moderate acute bronchiolitis or pneumonia in an emergency department setting in a low- to middle-income country.
ABBREVIATIONS


ALRI, acute lower respiratory infection; CED, Children's Emergency Department; NaCl, sodium chloride; PMGH, Port Moresby General Hospital; PNG, Papua New Guinea; RDS, respiratory distress score; SpO 2 , oxygen saturation by pulse oximetry.",2020,In those receiving normal saline oxygen saturation measured by pulse oximetry (SpO 2 ) increased by a mean of 7% (95% CI 6.0-7.9) to 90.7% at 4 hours.,"['moderate acute bronchiolitis or pneumonia in an emergency department setting in a low- to middle-income country', ""Port Moresby General Hospital Children's Emergency Department (CED"", 'moderate acute bronchiolitis and pneumonia in a low- to middle-income country', 'Abbreviations ', '199 patients participated; 100 patients', 'Methods : Children <2\xa0years of age presenting with a clinical diagnosis of moderate acute bronchiolitis or moderate pneumonia']","[' ', 'nebulised normal saline', 'standard care alone or with nebulised normal saline administered hourly', 'normal saline', 'Nebulised normal saline']","['respiratory distress scores: mean RDS', 'pulse oximetry (SpO 2 ', 'RDS', 'respiratory distress scores (RDS) and oxygen saturation between 0 and 4\xa0hours, and admission rates']","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0001311', 'cui_str': 'Acute capillary bronchiolitis'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0000723', 'cui_str': 'Abbreviations'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0558292', 'cui_str': 'Hourly (qualifier value)'}]","[{'cui': 'C0476273', 'cui_str': 'Respiratory distress (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0034108', 'cui_str': 'Oximetry, Pulse'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C1292426', 'cui_str': '4 hours (qualifier value)'}]",199.0,0.259124,In those receiving normal saline oxygen saturation measured by pulse oximetry (SpO 2 ) increased by a mean of 7% (95% CI 6.0-7.9) to 90.7% at 4 hours.,"[{'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Pukai', 'Affiliation': 'Paediatrics Department, Port Moresby General Hospital , Port Moresby, Papua New Guinea.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Duke', 'Affiliation': 'Discipline of Child Health, School of Medicine and Health Sciences, University of Papua New Guinea , Port Moresby Papua New Guinea.'}]",Paediatrics and international child health,['10.1080/20469047.2020.1725338']
1014,32042773,PEEP guided by electrical impedance tomography during one-lung ventilation in elderly patients undergoing thoracoscopic surgery.,"Background


To examine the influence of positive end-expiratory pressure (PEEP) settings on lung mechanics and oxygenation in elderly patients undergoing thoracoscopic surgery.
Methods


One hundred patients aged >65 years were randomly allocated into either the PEEP 5  or the electrical impedance tomography (EIT) group (PEEP EIT ). Each group underwent volume-controlled ventilation (tidal volume 6 mL/kg predicted body weight) with the PEEP either fixed at 5 cmH 2 O or set at an individualized EIT setting. The primary endpoint was the ratio of the arterial oxygen partial pressure to the fractional inspired oxygen (PaO 2 /FiO 2 ). The secondary endpoints included the driving pressure, and dynamic respiratory system compliance (C dyn ). Other outcomes, such as the mean airway pressure (P mean ), mean arterial pressure (MAP), lung complications and the length of hospital stay were explored.
Results


The optimal PEEP set by EIT was significantly higher (range from 9-13 cmH 2 O) than the fixed PEEP. PaO 2 /FiO 2  was 47 mmHg higher (95% CI: 7-86 mmHg; P=0.021), C dyn  was 4.3 mL/cmH 2 O higher (95% CI: 2.1-6.7 cmH 2 O; P<0.001), and the driving pressure was 3.7 cmH 2 O lower (95% CI: 2.2-5.1 mmH 2 O; P<0.001) at 0.5 h during one-lung ventilation (OLV) in the PEEP EIT  group than in the PEEP 5  group. At 1 h during OLV, PaO 2 /FiO 2  was 93 mmHg higher (95% CI: 58-128 mmHg; P<0.001), C dyn  was 4.4 mL/cmH 2 O higher (95% CI: 1.9-6.9 mL/cmH 2 O; P=0.001), and the driving pressure was 4.9 cmH 2 O lower (95% CI: 3.8-6.1 cmH 2 O; P<0.001) in the PEEP EIT  group than in the PEEP 5  group. PaO 2 /FiO 2  was 107 mmHg higher (95% CI: 56-158 mmHg; P<0.001) in the PEEP EIT  group than in the PEEP 5  group during double-lung ventilation at the end of surgery.
Conclusions


PEEP values determined with EIT effectively improved oxygenation and lung mechanics during one lung ventilation in elderly patients undergoing thoracoscopic surgery.",2019,"PaO 2 /FiO 2  was 47 mmHg higher (95% CI: 7-86 mmHg; P=0.021), C dyn  was 4.3 mL/cmH 2","['elderly patients undergoing thoracoscopic surgery', 'One hundred patients aged >65 years']","['positive end-expiratory pressure (PEEP) settings', 'PEEP guided by electrical impedance tomography', 'volume-controlled ventilation (tidal volume 6 mL/kg predicted body weight) with the PEEP either fixed at 5 cmH 2 O or set at an individualized EIT setting', 'PEEP 5  or the electrical impedance tomography (EIT) group (PEEP EIT ']","['driving pressure', 'oxygenation and lung mechanics', 'mean airway pressure (P mean ), mean arterial pressure (MAP), lung complications and the length of hospital stay', 'driving pressure, and dynamic respiratory system compliance (C dyn ', 'ratio of the arterial oxygen partial pressure to the fractional inspired oxygen (PaO 2 /FiO 2 ']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751551', 'cui_str': 'Surgical Procedures, Thoracoscopic'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0807495', 'cui_str': 'Positive end expiratory pressure setting'}, {'cui': 'C0863179', 'cui_str': 'Peeping'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0162537', 'cui_str': 'Electrical Impedance'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C1320708', 'cui_str': 'Volume controlled ventilation'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C3541375', 'cui_str': 'RESPIRATORY SYSTEM'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}]",100.0,0.152047,"PaO 2 /FiO 2  was 47 mmHg higher (95% CI: 7-86 mmHg; P=0.021), C dyn  was 4.3 mL/cmH 2","[{'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, China.'}, {'ForeName': 'Chengya', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, China.'}, {'ForeName': 'Meiying', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, China.'}, {'ForeName': 'Jingxiang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, China.'}, {'ForeName': 'Inez', 'Initials': 'I', 'LastName': 'Frerichs', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Medical Center of Schleswig-Holstein, Campus Kiel, Germany.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Moeller', 'Affiliation': 'Institute of Technical Medicine, Furtwangen University, Villingen-Schwenningen, Germany.'}, {'ForeName': 'Zhanqi', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Institute of Technical Medicine, Furtwangen University, Villingen-Schwenningen, Germany.'}]",Annals of translational medicine,['10.21037/atm.2019.11.95']
1015,32168288,Impact of Simulation-Based Learning on National Ranking Medical Examination Results in France: A Randomized Trial (SimECNi Study).,"INTRODUCTION


In France, the National Ranking Examination (ECNi) evaluates medical students based on their clinical reasoning. Simulation-based education on ECNi preparation has not been assessed. Our objective is to establish the added value of high-fidelity (HF) simulation-based learning in ECNi preparation compared with the current standard.
METHODS


We performed a controlled, prospective study. Fifth-year medical students from Nancy and Nice participated in a 3-phase process. In phase 1, students were tested on 6 themes (A-F) that were each presented as an ECNi clinical case and were randomized into 2 groups (#1 and #2). A 20-point grading scale was used. In phase 2, group #1 carried out HF simulation on themes A, B, and C, whereas group #2 did so on themes D, E, and F. Students were tested, in phase 3, with a new set of clinical cases on the same 6 themes. Progression in scores between phases 1 and 3 was analyzed.
RESULTS


One hundred sixty-six medical students randomized into 2 groups partook in the study. In phase 1, there was no significant difference in scores between groups. In phase 3, group #1 had significantly higher scores than group #2 for cases A, B, and C. Scores were significantly higher in group #2 for cases D, E, and F. Average scoring significantly improved between phases 1 and 3 with a 1.4-point gain for cases A, B, and C in group #1 and a 2.10-point gain for cases D, E, and F in group #2.
CONCLUSIONS


Our study shows that HF simulation learning significantly increases ECNi-like test results when compared with traditional forms.",2020,"In phase 3, group #1 had significantly higher scores than group #2 for cases A, B, and C. Scores were significantly higher in group #2 for cases D, E, and F. Average","['One hundred sixty-six medical students', 'France', 'Fifth-year medical students from Nancy and Nice participated in a 3-phase process']","['Simulation-Based Learning', 'HF simulation learning']",[],"[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0721912', 'cui_str': ""N'ICE""}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}]",[],166.0,0.018537,"In phase 3, group #1 had significantly higher scores than group #2 for cases A, B, and C. Scores were significantly higher in group #2 for cases D, E, and F. Average","[{'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Galland', 'Affiliation': ""From the Service de Médecine Interne (J.G.), Hôpital Lariboisière, Assistance Publique -Hôpitaux de Paris; Sorbonne Université Faculté de Médecine Diderot, Université de Paris Diderot (J.G.), faculté de médecine Sorbonne, F-75020 Paris; Service de Médecine Interne (N.M., M.L.), Hôpital Archet 1, CHU Nice; Université de Nice Sophia-Antipolis (M.L., J.-P.F.), Faculté de Médecine de Nice, Nice; Université de Lorraine (H.H., C.B., M.B.), faculté de médecine de Nancy, Vandœuvre-Lès-Nancy; Unité de méthodologie (C.B.), data management et statistique, DRCI, CHRU de Nancy, Nancy; Service de Médecine Générale d'Urgence (J.-P.F.), Hôpital Saint Roch, CHU, Nice; and Service de Neuroradiologie (M.B.), Hôpital Central, CHRU Nancy, Nancy, France.""}, {'ForeName': 'Nihal', 'Initials': 'N', 'LastName': 'Martis', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Levraut', 'Affiliation': ''}, {'ForeName': 'Hind', 'Initials': 'H', 'LastName': 'Hani', 'Affiliation': ''}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Baumann', 'Affiliation': ''}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Fournier', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Braun', 'Affiliation': ''}]",Simulation in healthcare : journal of the Society for Simulation in Healthcare,['10.1097/SIH.0000000000000431']
1016,32500725,Evaluation of the Switch From Amiodarone to Dronedarone in Patients With Atrial Fibrillation: Results of the ARTEMIS AF Studies.,"BACKGROUND


Switching between antiarrhythmic drugs is timed to minimize arrhythmia recurrence and adverse reactions. Dronedarone and amiodarone have similar electrophysiological profiles; however, little is known about the optimal timing of switching, given the long half-life of amiodarone.
METHODS


The ARTEMIS atrial fibrillation (AF) Loading and Long-term studies evaluated switching patients with paroxysmal/persistent AF from amiodarone to dronedarone. Patients were randomized based on the timing of the switch: immediate, after a 2-week, or after a 4-week washout of amiodarone. Patients who did not convert to sinus rhythm after amiodarone loading underwent electrical cardioversion. The primary objectives were, for the Loading study, to evaluate recurrence of AF ≤60 days; and for the Long-term study, to profile the pharmacokinetics of dronedarone and its metabolite according to different timings of dronedarone initiation.
RESULTS


In ARTEMIS AF Loading, 176 were randomized (planned 768) after a 28 ± 2 days load of oral amiodarone. Atrial fibrillation recurrence trended less in the immediate switch versus 4-week washout group (hazard ratio [HR] = 0.65 [97.5% CI: 0.34-1.23];  P  = .14) and in the 2-week washout versus the 4-week washout group (HR = 0.75 [97.5% CI: 0.41-1.37];  P  = .32). In ARTEMIS AF Long-term, 108 patients were randomized (planned 105). Pharmacokinetic analyses (n = 97) showed no significant differences for dronedarone/SR35021 exposures in the 3 groups.
CONCLUSION


The trial was terminated early due to poor recruitment and so our findings are limited by low numbers. However, immediate switching from amiodarone to dronedarone appeared to be well tolerated and safe.",2020,"Pharmacokinetic analyses (n = 97) showed no significant differences for dronedarone/SR35021 exposures in the 3 groups.
","['108 patients were randomized (planned 105', 'Patients With Atrial Fibrillation', 'Patients who did not convert to sinus rhythm after amiodarone loading underwent electrical cardioversion', 'patients with paroxysmal/persistent AF from']","['dronedarone', 'amiodarone to dronedarone', 'amiodarone', 'Dronedarone', 'Amiodarone']","['Atrial fibrillation recurrence', 'tolerated and safe']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}]","[{'cui': 'C0766326', 'cui_str': 'dronedarone'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",108.0,0.0279373,"Pharmacokinetic analyses (n = 97) showed no significant differences for dronedarone/SR35021 exposures in the 3 groups.
","[{'ForeName': 'Gerald V', 'Initials': 'GV', 'LastName': 'Naccarelli', 'Affiliation': 'Division of Cardiology, Heart and Vascular Institute, Penn State University College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Camm', 'Affiliation': ""Cardiology Clinical Academic Group Molecular & Clinical Sciences Institute, St George's University of London, London, UK.""}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Le Heuzey', 'Affiliation': 'Hôpital Européen Georges Pompidou, Université Paris V René Descartes, Paris, France.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Lombardi', 'Affiliation': 'Cardiologia, Fondazione IRCCS Ospedale Maggiore Policlinico, Milan, Italy.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Tamargo', 'Affiliation': 'Department of Pharmacology and Toxicology, School of Medicine, CIBERCV, University Complutense, Madrid, Spain.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Martinez', 'Affiliation': 'Sanofi, Montpellier, France.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Naditch-Brûlé', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248420926874']
1017,32498113,"Pharmacokinetics, Safety, and Bioequivalence of Two Empagliflozin Formulations after Single Oral Administration under Fasting and Fed Conditions in Healthy Chinese Subjects: An Open-label Randomized Single-dose Two-sequence, Two-treatment, Two-period Crossover Study.","OBJECTIVES


To evaluate the pharmacokinetic properties and safety of empagliflozin, and the bioequivalence of test formulation empagliflozin tablet compared with the brand-name drug Jardiance (reference formulation) after single oral administration under fasting and fed conditions in healthy Chinese subjects.
METHODS


An open-label randomized single-dose two-sequence, two-treatment, two-period crossover study was conducted in healthy Chinese subjects, with 30 subjects under fasting condition and another 30 subjects under fed condition. Under each condition, subjects received a single oral administration of either the test or reference empagliflozin formulation, and then they received a single oral dose of the other formulation after a 7-day washout period.
RESULTS


A total of 29 subjects under each condition completed the study. The maximum plasma drug concentration, the area under the plasma concentration-time curve (AUC) from 0 to t (AUC 0-t  ), and the AUC from 0 to infinity (AUC 0-∞  ) of test formulation and reference formulation was 186.90 ± 47.21 and 190.60 ± 40.94 ng/ml, 1303.04 ± 234.28 and 1267.78 ± 217.07 ng·hour/ml, and 1328.08 ± 243.84 and 1293.22 ± 224.82 ng·hour/ml under fasting condition, and 151.55 ± 23.86 and 154.08 ± 30.40 ng/ml, 1215.65 ± 197.62 and 1199.26 ± 186.23 ng·hour/ml, and 1241.76 ± 202.47 and 1225.54 ± 192.10 ng·hour/ml under fed condition, respectively.
CONCLUSIONS


The two formulations of empagliflozin were bioequivalent, and both were generally well tolerated under fasting and fed conditions.",2020,"The maximum plasma concentration (C max  ), the area under the plasma concentration-time curve (AUC) from 0 to t (AUC 0-t  ), and the AUC from 0 to infinity (AUC 0-∞  ) of test formulation and reference formulation was 186.90 ± 47.21 and 190.60 ± 40.94 ng/mL, 1303.04 ± 234.28 and 1267.78 ± 217.07 ng·h/mL, and 1328.08 ± 243.84 and 1293.22 ± 224.82 ng·h/mL under fasting condition, and 151.55 ± 23.86 and 154.08 ± 30.40 ng/mL, 1215.65 ± 197.62 and 1199.26 ± 186.23 ng·h/mL, and 1241.76 ± 202.47 and 1225.54 ± 192.10 ng·h/mL under fed condition, respectively.
","['29 subjects under each condition completed the study', 'healthy Chinese subjects', 'healthy Chinese subjects, with 30 subjects under fasting condition and another 30 subjects under fed condition']","['empagliflozin formulations', 'empagliflozin formulation', 'empagliflozin']","['maximum plasma concentration (C max  ), the area under the plasma concentration-time curve (AUC', 'Pharmacokinetics, safety, and bioequivalence']","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}]",30.0,0.0489666,"The maximum plasma concentration (C max  ), the area under the plasma concentration-time curve (AUC) from 0 to t (AUC 0-t  ), and the AUC from 0 to infinity (AUC 0-∞  ) of test formulation and reference formulation was 186.90 ± 47.21 and 190.60 ± 40.94 ng/mL, 1303.04 ± 234.28 and 1267.78 ± 217.07 ng·h/mL, and 1328.08 ± 243.84 and 1293.22 ± 224.82 ng·h/mL under fasting condition, and 151.55 ± 23.86 and 154.08 ± 30.40 ng/mL, 1215.65 ± 197.62 and 1199.26 ± 186.23 ng·h/mL, and 1241.76 ± 202.47 and 1225.54 ± 192.10 ng·h/mL under fed condition, respectively.
","[{'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Aihua', 'Initials': 'A', 'LastName': 'Du', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Siqi', 'Initials': 'S', 'LastName': 'Zang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Xiaona', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Zejuan', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Haiqing', 'Initials': 'H', 'LastName': 'Zhen', 'Affiliation': 'GCP Office, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Yujing', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Beijing Sun-Novo Pharmaceutical Research Co., Ltd., Beijing, China.'}, {'ForeName': 'Shuya', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""President's Office, Aerospace 731 Hospital, Beijing, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}]",Pharmacotherapy,['10.1002/phar.2432']
1018,32502164,Effect of practice exergames on the mood states and self-esteem of elementary school boys and girls during physical education classes: A cluster-randomized controlled natural experiment.,"Reduced physical exercise can impact children's mental health. Use of active electronic games can help promote psychological health. Physical education (PE class) uses different resources, methods, and contents to promote student health. We investigated the effect of exergames on the mood and self-esteem of children and compare it that of with traditional PE classes. From a sample of 213 children (7-11 years old), 140 from 10 classes of the fourth and fifth grades of elementary school (59 boys, 81 girls; mean age 9.41±0.48 years), allocated to an experimental group (EG; n = 68; five clusters) and a PE group (PE; n = 72; five clusters), participated in this experimental controlled study. The EG practiced exergames during three 40-minute classes, and the PE group held three routine curricular PE classes. Brunel's Mood Scale and Rosenberg's Self-Esteem Scale were applied. Repeated measures ANOVA identified differences between sexes and groups. The main results of the EG demonstrated reduced tension in girls (p <0.05; ES: 0.62; 95% CI: 0.17-1.05). Regarding sex comparisons, anger was lower in girls (F: 4.57; p <0.05; ES: 0.61; 95% CI: 0.11-1.11) in the EG. Vigor was higher in girls in the EG than in those in the PE group (F: 5.46; p <0.05; ES: 0.56; 95% CI: 0.12-1.01). The main results of the PE group indicated increased self-esteem in boys (p <0.05; ES: 0.58; 95% CI: 0.08-1.07) and reduction of girls' mental confusion (p <0.05; ES 0.58; 95% CI 0.15-1.06). Thus, exergames impact boys' and girls' self-esteem and mood, as well as traditional physical education classes. Further study on exergames in schools is essential, with long-term effects on physical and mental health. Exergames bring interesting, varied content, technology, and innovation that can increase the attractiveness of physical education.",2020,The main results of the EG demonstrated reduced tension in girls (p <0.05; ES: 0.62; 95% CI: 0.17-1.05).,"['213 children (7-11 years old), 140 from 10 classes of the fourth and fifth grades of elementary school (59 boys, 81 girls; mean age 9.41±0.48 years', 'elementary school boys and girls during physical education classes']","['physical exercise', 'Physical education (PE class', 'practice exergames', 'active electronic games']","[""Brunel's Mood Scale and Rosenberg's Self-Esteem Scale"", 'Vigor', ""reduction of girls' mental confusion"", 'mood states and self-esteem', 'self-esteem']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582666', 'cui_str': 'Rosenberg self-esteem scale'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}]",213.0,0.0680954,The main results of the EG demonstrated reduced tension in girls (p <0.05; ES: 0.62; 95% CI: 0.17-1.05).,"[{'ForeName': 'Alexandro', 'Initials': 'A', 'LastName': 'Andrade', 'Affiliation': 'Laboratory of Sport and Exercise Psychology, Santa Catarina State University, Florianópolis, Brazil.'}, {'ForeName': 'Whyllerton Mayron da', 'Initials': 'WMD', 'LastName': 'Cruz', 'Affiliation': 'Laboratory of Sport and Exercise Psychology, Santa Catarina State University, Florianópolis, Brazil.'}, {'ForeName': 'Clara Knierim', 'Initials': 'CK', 'LastName': 'Correia', 'Affiliation': 'Laboratory of Aquatic Biomechanics, Santa Catarina State University, Florianópolis, Brazil.'}, {'ForeName': 'Ana Luiza Goya', 'Initials': 'ALG', 'LastName': 'Santos', 'Affiliation': 'Laboratory of Sport and Exercise Psychology, Santa Catarina State University, Florianópolis, Brazil.'}, {'ForeName': 'Guilherme Guimarães', 'Initials': 'GG', 'LastName': 'Bevilacqua', 'Affiliation': 'Laboratory of Sport and Exercise Psychology, Santa Catarina State University, Florianópolis, Brazil.'}]",PloS one,['10.1371/journal.pone.0232392']
1019,32502179,"Efficacy of topical bevacizumab 0.05% eye drops in dry eye disease: A double-masked, randomized trial.","The objective of this double-masked, placebo-controlled, randomized trial was to assess the efficacy and safety of bevacizumab 0.05% eye drops in dry eye patients. This study included Dry Eye Workshop Study (DEWS) Grade 3-4 dry eye participants (n = 31) whose tear break-up time (TBUT) was ≤5 seconds(s). Participants were randomized to undergo treatment with either bevacizumab 0.05% eye drops (n = 19) or placebo (n = 12). The primary outcome was TBUT, and the proportion of responders (increase of ≥3s in TBUT at week 12), ocular surface disease index (OSDI) score, Schirmer test, and Oxford scheme grade were secondary outcomes. All outcomes were measured at 1-, 4- and 12 weeks. TBUT in bevacizumab group differed significantly from TBUT in placebo group within 12 weeks (P = 0.001). Moreover, the improvement of TBUT in bevacizumab group versus placebo group at 4- and 12 weeks differed significantly from that difference at baseline (P = 0.002 and P = 0.003, respectively). The proportion of participants achieving increase of 3 seconds or more of TBUT at week 12 in the bevacizumab group was significantly greater than that in the placebo group (P = 0.02). Oxford scheme grade at 1-, 4- and 12 weeks differed significantly from the values at baseline in bevacizumab group (P = 0.001, P = 0.01, and P = 0.03, respectively). OSDI scores at 1-, 4- and 12-week follow-ups were significantly lower than that at baseline in bevacizumab group (P<0.001 at each follow-up). Schirmer test were not significantly different within or between groups (the lowest P = 0.92). No adverse events occurred in this study. Patients treated with bevacizumab 0.05% eye drops showed significant improvement in tear film stability, corneal staining and symptoms.",2020,TBUT in bevacizumab group differed significantly from TBUT in placebo group within 12 weeks (P = 0.001).,"['dry eye patients', 'dry eye disease']","['bevacizumab 0.05% eye drops', 'topical bevacizumab', 'bevacizumab', 'placebo']","['tear film stability, corneal staining and symptoms', 'OSDI scores', 'proportion of participants achieving increase of 3 seconds or more of TBUT', 'efficacy and safety', 'TBUT, and the proportion of responders (increase of ≥3s in TBUT at week 12), ocular surface disease index (OSDI) score, Schirmer test, and Oxford scheme grade', 'adverse events']","[{'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",31.0,0.52162,TBUT in bevacizumab group differed significantly from TBUT in placebo group within 12 weeks (P = 0.001).,"[{'ForeName': 'Ngamjit', 'Initials': 'N', 'LastName': 'Kasetsuwan', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Kanawat', 'Initials': 'K', 'LastName': 'Chantaralawan', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Usanee', 'Initials': 'U', 'LastName': 'Reinprayoon', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Lita', 'Initials': 'L', 'LastName': 'Uthaithammarat', 'Affiliation': 'Department of Anatomy, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}]",PloS one,['10.1371/journal.pone.0234186']
1020,32502206,Digital versus analogue record systems for mass casualty incidents at sea-Results from an exploratory study.,"OBJECTIVE


Mis-triage may have serious consequences for patients in mass casualty incidents (MCI) at sea. The purpose of this study was to assess outcome, reliability and validity of an analogue and a digital recording system for triage of a MCI at sea.
METHODS


The study based on a triage exercise conducted with a cross-over-design. Forty-eight volunteers were presented a fictional MCI with 50 cases. The volunteers were randomly assigned to start with the analogue (Group A, starting with the analogue followed by the digital system) or digital system (Group B, starting with the digital followed by the analogue system). Triage score distribution and agreement between the triage methods and a predefined standard were reported. Reliability was analysed using Cronbach's Alpha and Cohen's Kappa. Validity was measured through sensitivity, specificity and predictive value. Treatment, period and carry-over-effects were analysed using a linear mixed-effects model.
RESULTS


The number of patients triaged (total: n = 3545) with the analogue system (n = 1914; 79.75%) was significantly higher (p = 0.001) than with the digital system (n = 1631; 67.96%). A trend towards a higher percentage of correct triages with the digital system was observed (p = 0.282). Ratio of under-triage was significantly smaller with the digital system (p = 0.001). Validity measured with Cronbach's Alpha and Cohen's Kappa was higher with the digital system. So was sensitivity (category; green: 80.67%, yellow: 73.24%, red: 83.54%; analogue: green: 93.28%, yellow: 82.36%, red: 94.04%) and specificity of the digital system (green: 78.07%, yellow: 63.75%, red: 66.25%; analogue: green: 85.50%, yellow: 79.88%, red: 91.50%). Comparing the predictive values and accuracy, the digital system showed higher scores than the analogue system. No significant patterns of carry-over-effects were observed.
CONCLUSIONS


Significant differences were found for the number of triages comparing the analogue and digital recording system. The digital system has a slightly higher reliability and validity than the analogue triage system.",2020,A trend towards a higher percentage of correct triages with the digital system was observed (p = 0.282).,"['patients in mass casualty incidents (MCI) at sea', 'Forty-eight volunteers were presented a fictional MCI with 50 cases']","['analogue (Group A, starting with the analogue followed by the digital system) or digital system', 'analogue']","['Ratio of under-triage', 'specificity of the digital system ', 'sensitivity, specificity and predictive value']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1955957', 'cui_str': 'Mass Casualty Incidents'}, {'cui': 'C0036493', 'cui_str': 'Sea'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",3545.0,0.0347985,A trend towards a higher percentage of correct triages with the digital system was observed (p = 0.282).,"[{'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Henning', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Mustafa Sinan', 'Initials': 'MS', 'LastName': 'Bakir', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Lyubomir', 'Initials': 'L', 'LastName': 'Haralambiev', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schulz-Drost', 'Affiliation': 'Department of Trauma Surgery, Helios Kliniken Schwerin, Schwerin, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hinz', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kohlmann', 'Affiliation': 'Institute for Community Medicine, Section Methods in Community Medicine, University Medicine Greifswald, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Ekkernkamp', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Gümbel', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}]",PloS one,['10.1371/journal.pone.0234156']
1021,32498073,Systematic manipulations of the biological stress systems result in sex-specific compensatory stress responses and negative mood outcomes.,"Women are twice as likely as men to be diagnosed with anxiety and mood disorders. One potential underlying mechanism is sex differences in physiological and psychological responses to stress; however, no studies to date have investigated this proposed mechanism experimentally. In a double-blind, placebo-controlled design, pharmacological challenges were administered to individually suppress the hypothalamic-pituitary-adrenal (HPA) axis, or the sympathetic nervous system (SNS) prior to stress exposure, to investigate sex differences in the resulting cross talk among the physiological and psychological stress responses. Sex-specific compensatory patterns and psychological effects emerged when the stress systems were manipulated. Men demonstrated heightened SNS reactivity to stress when the HPA axis was suppressed, and greater HPA reactivity after SNS suppression. This ability to react appropriately to the stressor, even with one system, did not lead to significant negative mood effects. In women, higher baseline activation (but dampened reactivity to stress) of SNS or HPA was observed when the other system was suppressed. This was coupled with worsened mood in response to stress when either stress system was compromised. Our results indicate that men and women may be differentially sensitive to fluctuations of their stress systems. This might be a potential link that underlies the sexual dimorphism in vulnerability for psychopathology.",2020,"This ability to react appropriately to the stressor, even with one system, did not lead to significant negative mood effects.",[],['placebo'],['HPA reactivity'],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.0182391,"This ability to react appropriately to the stressor, even with one system, did not lead to significant negative mood effects.","[{'ForeName': 'Nida', 'Initials': 'N', 'LastName': 'Ali', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada. nida.ali@mail.mcgill.ca.'}, {'ForeName': 'Jonas P', 'Initials': 'JP', 'LastName': 'Nitschke', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Cory', 'Initials': 'C', 'LastName': 'Cooperman', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Baldwin', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Pruessner', 'Affiliation': 'Faculty of Medicine, McGill Centre for Studies in Aging, McGill University, Montreal, QC, Canada.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0726-8']
1022,32497099,Redesign and validation of a computer programming course using Inductive Teaching Method.,"Inductive Teaching Method (ITM) promotes effective learning in technological education (Felder & Silverman, 1988). Students prefer ITM more as it makes the subject easily understandable (Goltermann, 2011). The ITM motivates the students to actively participate in class activities and therefore could be considered a better approach to teach computer programming. There has been little research on implementing ITM in computer science courses despite its potential to improve effective learning. In this research, an existing computer programming lab course is taught using a traditional Deductive Teaching Method (DTM). The course is redesigned and taught by adopting the ITM instead. Furthermore, a comprehensive plan has been devised to deliver the course content in computer labs. The course was evaluated in an experiment consisting of 81 undergraduate students. The students in the Experimental Group (EG) (N = 45) were taught using the redesigned ITM course, whereas the students in the Control Group (CG) (N = 36) were taught using the DTM course. The performance of both groups was compared in terms of the marks obtained by them. A pre-test conducted to compare pre-course mathematical and analytical abilities showed that CG was better in analytical reasoning with no significant differences in mathematical abilities. Three post-tests were used to evaluate the groups theoretical and practical competence in programming and showed EG improved performance with large, medium, and small effect sizes as compared to CG. The results of this research could help computer programming educators to implement inductive strategies that could improve the learning of the computer programming.",2020,"Three post-tests were used to evaluate the groups theoretical and practical competence in programming and showed EG improved performance with large, medium, and small effect sizes as compared to CG.",['81 undergraduate students'],['Inductive Teaching Method (ITM'],[],"[{'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0039403', 'cui_str': 'Teaching Methods'}]",[],45.0,0.0100507,"Three post-tests were used to evaluate the groups theoretical and practical competence in programming and showed EG improved performance with large, medium, and small effect sizes as compared to CG.","[{'ForeName': 'Iftikhar Ahmed', 'Initials': 'IA', 'LastName': 'Khan', 'Affiliation': 'Department of Computer Science, COMSATS University Islamabad, Abbottabad, Pakistan.'}, {'ForeName': 'Mehreen', 'Initials': 'M', 'LastName': 'Iftikhar', 'Affiliation': 'Department of Computer Science, COMSATS University Islamabad, Abbottabad, Pakistan.'}, {'ForeName': 'Syed Sajid', 'Initials': 'SS', 'LastName': 'Hussain', 'Affiliation': 'Department of Computer Science, COMSATS University Islamabad, Abbottabad, Pakistan.'}, {'ForeName': 'Attiqa', 'Initials': 'A', 'LastName': 'Rehman', 'Affiliation': 'Department of Computer Science, COMSATS University Islamabad, Abbottabad, Pakistan.'}, {'ForeName': 'Nosheen', 'Initials': 'N', 'LastName': 'Gul', 'Affiliation': 'Department of Computer Science, COMSATS University Islamabad, Abbottabad, Pakistan.'}, {'ForeName': 'Waqas', 'Initials': 'W', 'LastName': 'Jadoon', 'Affiliation': 'Department of Computer Science, COMSATS University Islamabad, Abbottabad, Pakistan.'}, {'ForeName': 'Babar', 'Initials': 'B', 'LastName': 'Nazir', 'Affiliation': 'Department of Computer Science, COMSATS University Islamabad, Abbottabad, Pakistan.'}]",PloS one,['10.1371/journal.pone.0233716']
1023,32503365,Effect of Stress Management Counseling on Self-Efficacy and Continuity of Exclusive Breastfeeding.,"Background:  Self-efficacy is an important motivational factor that can be affected by physiological responses such as stress.  Objective:  The study aimed to determine the effect of stress management counseling on self-efficacy and continuity of exclusive breastfeeding in mothers.  Materials and Methods:  This randomized controlled trial was carried out on 46 pregnant women recruited at three Childbirth Preparation Centers of Zanjan (Iran) in 2018. The eligible women were allocated into two intervention and control groups according to the block design. Stress management counseling was carried out individually in four sessions, twice a week at 35 and 36 weeks of gestation. The control group only received routine cares. The self-efficacy and continuity of exclusive breastfeeding were measured monthly up to 4 months after childbirth.  Results:  Breastfeeding self-efficacy showed a statistically significant difference between the two study groups at 1 and 4 months after childbirth ( p  = 0.001). More women in the control group terminated exclusive breastfeeding compared to those in the intervention group (16 (72.7%) versus 8 (34.8%),  p  = 0.013).  Conclusion:  The results showed that integration of stress management counseling in breastfeeding education package can improve the self-efficacy and continuation of breastfeeding in mothers.",2020,"More women in the control group terminated exclusive breastfeeding compared to those in the intervention group (16 (72.7%) versus 8 (34.8%),  p  = 0.013).  ","['46 pregnant women recruited at three Childbirth Preparation Centers of Zanjan (Iran) in 2018', 'mothers']","['routine cares', 'stress management counseling', 'Stress Management Counseling']","['exclusive breastfeeding', 'self-efficacy and continuity of exclusive breastfeeding', 'Self-Efficacy and Continuity of Exclusive Breastfeeding', 'self-efficacy and continuation of breastfeeding', 'Breastfeeding self-efficacy']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0150169', 'cui_str': 'Childbirth preparation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]",46.0,0.0306649,"More women in the control group terminated exclusive breastfeeding compared to those in the intervention group (16 (72.7%) versus 8 (34.8%),  p  = 0.013).  ","[{'ForeName': 'Elmira', 'Initials': 'E', 'LastName': 'Azizi', 'Affiliation': 'Department of Midwifery, Social Determinants of Health Research Center, School of Nursing and Midwifery, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Maleki', 'Affiliation': 'Department of Midwifery, Social Determinants of Health Research Center, School of Nursing and Midwifery, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Saeideh', 'Initials': 'S', 'LastName': 'Mazloomzadeh', 'Affiliation': 'Social Determinants of Health Research Center, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Pirzeh', 'Affiliation': 'Department of Psychiatry, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2019.0251']
1024,32506309,"Evaluation of Fixed-Dose Combinations of Ibuprofen and Acetaminophen in the Treatment of Postsurgical Dental Pain: A Pilot, Dose-Ranging, Randomized Study.","INTRODUCTION


Ibuprofen and acetaminophen provide analgesia via different mechanisms of action and do not exhibit drug-drug interactions; therefore, combining low doses of each may provide greater efficacy without compromising safety.
OBJECTIVES


The present study assessed the analgesic efficacy of fixed-dose combinations (FDCs) of ibuprofen/acetaminophen (IBU/APAP) compared with ibuprofen 400 mg and placebo.
METHODS


This 12-h, double-blind, proof-of-concept study compared three FDCs of IBU/APAP (200 mg/500 mg, 250 mg/500 mg, and 300 mg/500 mg) with ibuprofen 400 mg and placebo in patients with moderate-to-severe pain following third molar extraction. The primary endpoint was the time-weighted sum of pain relief and pain intensity difference scores from 0 to 8 h after dosing (SPRID[4] 0-8 ). Time to meaningful pain relief (TMPR), duration of pain relief, and adverse events (AEs) were also assessed.
RESULTS


In total, 394 patients were randomized. All active treatments were superior to placebo for SPRID[4] 0-8  (all p < 0.001) but not significantly different from ibuprofen 400 mg. Median TMPR with FDCs and ibuprofen (44.5-54.1 and 56.2 min, respectively) was faster than with placebo (> 720 min; all p < 0.001 vs. placebo). Duration of pain relief was similar with the FDCs and ibuprofen 400 mg (9.7 -11.1 h) and longer than with placebo (1.6 h; all p < 0.001). AE incidence was comparable with all treatments.
CONCLUSION


Each IBU/APAP FDC provided analgesic efficacy comparable to that with ibuprofen 400 mg and superior to that with placebo. Each FDC provided MPR in < 1 h, duration of pain relief > 9 h, and tolerability similar to that with ibuprofen and placebo. CLINICALTRIALS.
GOV REGISTRATION


NCT01559259.",2020,All active treatments were superior to placebo for SPRID[4] 0-8  (all p < 0.001) but not significantly different from ibuprofen 400 mg.,"['patients with moderate-to-severe pain following third molar extraction', '394 patients were randomized']","['ibuprofen 400\xa0mg and placebo', 'ibuprofen/acetaminophen (IBU/APAP', 'placebo', 'FDCs and ibuprofen', 'Ibuprofen and Acetaminophen', 'APAP', 'ibuprofen', 'Ibuprofen and acetaminophen']","['Median TMPR with FDCs and ibuprofen', 'time-weighted sum of pain relief and pain intensity difference scores', 'Time to meaningful pain relief (TMPR), duration of pain relief, and adverse events (AEs', 'Duration of pain relief', 'duration of pain relief', 'analgesic efficacy', 'AE incidence', 'Postsurgical Dental Pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0992428', 'cui_str': 'Ibuprofen 400 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0721022', 'cui_str': 'Ibu'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040460', 'cui_str': 'Toothache'}]",394.0,0.565432,All active treatments were superior to placebo for SPRID[4] 0-8  (all p < 0.001) but not significantly different from ibuprofen 400 mg.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kellstein', 'Affiliation': 'Pfizer Consumer Healthcare, Madison, NJ, USA. david.kellstein@gmail.com.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Leyva', 'Affiliation': 'Pfizer Consumer Healthcare, Madison, NJ, USA.'}]",Drugs in R&D,['10.1007/s40268-020-00310-7']
1025,32499312,The Diet of Higher Insulinemic Potential Is Not Associated with Worse Survival in Patients with Stage III Colon Cancer (Alliance).,"BACKGROUND


Hyperinsulinemia is considered to be important in the development of colon cancer, but few studies have investigated the associations of hyperinsulinemia with colon cancer survival via dietary scores.
METHODS


Empirical dietary index for hyperinsulinemia (EDIH) was derived to assess the insulinemic potential of daily diets reflecting the long-term insulin exposure, with higher (more positive) scores indicating higher insulinemic diets. We prospectively estimated the HRs and 95% confidence intervals (CI) to investigate the association of EDIH with disease-free, recurrence-free, and overall survival among patients with stage III colon cancer (1999-2009) enrolled in a randomized adjuvant chemotherapy trial (CALGB 89803).
RESULTS


Of 1,024 patients (median follow-up: 7.3 years), 311 died, 350 had recurrences, and 394 had events for disease-free survival. Compared with patients in the lowest quintile of EDIH, the corresponding HRs of patients in the highest quintile for disease-free survival events, cancer recurrence, and overall mortality were 0.80 (95% CI, 0.56-1.15), 0.76 (95% CI, 0.51-1.11), and 0.77 (95% CI, 0.52-1.14).
CONCLUSIONS


Higher EDIH was not associated with the risk of colon cancer recurrence or mortality in this population of patients with stage III colon cancer.
IMPACT


EDIH, as a measure of dietary insulinemic potential, may be associated with colon cancer risk but not survival in patients with late-stage colon cancer.",2020,"CONCLUSIONS


Higher EDIH was not associated with the risk of colon cancer recurrence or mortality in this population of stage III colon cancer patients.
","['late stage colon cancer patients', 'Patients with Stage III Colon Cancer (Alliance', 'patients with stage III colon cancer (1999-2009) enrolled in a randomized adjuvant chemotherapy trial (CALGB 89803', 'stage III colon cancer patients']",[],"['hazard ratios (HR', 'risk of colon cancer recurrence or mortality', 'EDIH with disease-free, recurrence-free, and overall survival', 'disease-free survival', 'disease-free survival events, cancer recurrence, and overall mortality']","[{'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278480', 'cui_str': 'Carcinoma of colon, stage III'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",,0.343602,"CONCLUSIONS


Higher EDIH was not associated with the risk of colon cancer recurrence or mortality in this population of stage III colon cancer patients.
","[{'ForeName': 'En', 'Initials': 'E', 'LastName': 'Cheng', 'Affiliation': 'Department of Chronic Disease Epidemiology, Yale School of Public Health, New Haven, Connecticut.'}, {'ForeName': 'Sui', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Division of Medical Oncology, Dana-Farber/Partners Cancer Care, Boston, Massachusetts.'}, {'ForeName': 'Fang-Shu', 'Initials': 'FS', 'LastName': 'Ou', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mullen', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Kimmie', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': 'Division of Medical Oncology, Dana-Farber/Partners Cancer Care, Boston, Massachusetts.'}, {'ForeName': 'Leonard B', 'Initials': 'LB', 'LastName': 'Saltz', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mayer', 'Affiliation': 'Division of Medical Oncology, Dana-Farber/Partners Cancer Care, Boston, Massachusetts.'}, {'ForeName': 'Rex B', 'Initials': 'RB', 'LastName': 'Mowat', 'Affiliation': 'Toledo Community Hospital Oncology Program, Toledo, Ohio.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Whittom', 'Affiliation': 'Hôpital du Sacré-Coeur de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hantel', 'Affiliation': 'Loyola University, Stritch School of Medicine, Naperville, Illinois.'}, {'ForeName': 'Al', 'Initials': 'A', 'LastName': 'Benson', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Atienza', 'Affiliation': 'Virginia Oncology Associates, Norfolk, Virginia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Messino', 'Affiliation': 'Southeast Cancer Oncology Research Consortium, Mission Hospitals, Asheville, North Carolina.'}, {'ForeName': 'Hedy', 'Initials': 'H', 'LastName': 'Kindler', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Giovannucci', 'Affiliation': 'Department of Epidemiology and Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Van Blarigan', 'Affiliation': 'Department of Epidemiology and Biostatistics and Department of Urology, University of California, San Francisco, California.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Meyerhardt', 'Affiliation': 'Division of Medical Oncology, Dana-Farber/Partners Cancer Care, Boston, Massachusetts.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': 'Department of Chronic Disease Epidemiology, Yale School of Public Health, New Haven, Connecticut. charles.fuchs@yale.edu.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-19-1454']
1026,32507863,Moxifloxacin versus amoxicillin plus metronidazole as adjunctive therapy for generalized aggressive periodontitis: a pilot randomized controlled clinical trial.,"OBJECTIVE


Adjunctive antimicrobials improve probing depth and clinical attachment loss compared with subgingival debridement (SD) alone in patients with aggressive periodontitis. The microbiologic and clinical effectiveness of moxifloxacin (MOX) and amoxicillin plus metronidazole (AMOX+ME) as adjunctive therapies for generalized aggressive periodontitis were compared.
METHOD AND MATERIALS


This pilot randomized controlled clinical trial included 36 patients who were assigned to one of three therapy groups: SD plus systemic MOX (400 mg QD for 7 days), SD plus systemic AMOX+ME (500 mg TID each for 7 days), or SD plus placebo. Probing depth, clinical attachment loss, bleeding on probing, and plaque were recorded at baseline and 3 and 6 months after treatment. Subgingival plaque samples were analyzed.
RESULTS


All treatments resulted in significant probing depth and clinical attachment loss reduction compared with the baseline values (P < .0001 for all), with the effects still present at 6 months posttreatment, but the patients taking antibiotic protocols presented the most significant gains (P < .0001). There was a significant reduction in the occurrence of gingival pockets ≥ 6 mm at 6 months in all treatment groups (P < .0001), favoring the MOX and AMOX+ME groups. Adjunctive MOX diminished subgingival Aggregatibacter actinomycetemcomitans to unnoticeable stages, after the follow-up period. Adverse events were noted only in some patients of the AMOX+ME group.
CONCLUSIONS


This pilot clinical trial proposes that using MOX and AMOX+ME as adjuncts to SD improves the clinical and microbiologic parameters in comparison to mechanical therapy alone; however, the MOX protocol did not cause adverse events and decreased subgingival A actinomycetemcomitans to imperceptible levels.",2020,"All treatments resulted in significant probing depth and clinical attachment loss reduction compared with the baseline values (P < .0001 for all), with the effects still present at 6 months posttreatment, but the patients taking antibiotic protocols presented the most significant gains (P < .0001).","['generalized aggressive periodontitis', '36 patients who were assigned to one of three therapy groups', 'patients with aggressive periodontitis']","['SD plus systemic AMOX+ME', 'subgingival debridement (SD) alone', 'AMOX+ME', 'Moxifloxacin', 'MOX and AMOX+ME', 'amoxicillin plus metronidazole', 'SD plus systemic MOX', 'moxifloxacin (MOX) and amoxicillin plus metronidazole (AMOX+ME', 'placebo']","['Adverse events', 'significant probing depth and clinical attachment loss reduction', 'Probing depth, clinical attachment loss, bleeding on probing, and plaque', 'probing depth and clinical attachment loss', 'occurrence of gingival pockets']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0001342', 'cui_str': 'Acute periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}]","[{'cui': 'C0595817', 'cui_str': 'Subgingival route'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0017571', 'cui_str': 'Gingival pocket'}]",36.0,0.171925,"All treatments resulted in significant probing depth and clinical attachment loss reduction compared with the baseline values (P < .0001 for all), with the effects still present at 6 months posttreatment, but the patients taking antibiotic protocols presented the most significant gains (P < .0001).","[{'ForeName': 'Carlos M', 'Initials': 'CM', 'LastName': 'Ardila', 'Affiliation': ''}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Flórez-Flórez', 'Affiliation': ''}, {'ForeName': 'Luis-David', 'Initials': 'LD', 'LastName': 'Castañeda-Parra', 'Affiliation': ''}, {'ForeName': 'Isabel C', 'Initials': 'IC', 'LastName': 'Guzmán', 'Affiliation': ''}, {'ForeName': 'Jader A', 'Initials': 'JA', 'LastName': 'Bedoya-García', 'Affiliation': ''}]","Quintessence international (Berlin, Germany : 1985)",['10.3290/j.qi.a44715']
1027,32498373,High-Intensity Training Reduces CVD Risk Factors among Rotating Shift Workers: An Eight-Week Intervention in Industry.,"Rotating shift work is associated with risk factors for cardiovascular disease (CVD). We have studied the effect of 17 min high-intensity training three times a week over eight weeks on CVD risk factors among shift workers.  Sixty-five shift workers from two plants were recruited. They were all deemed healthy at the initial health screening and in 100% work. From plant A, 42 workers, and plant B, 23 workers participated. After the intervention, 56 workers were retested. The intervention group consisted of 19 participants from plant A who had participated in at least 10 sessions. Twenty workers from plant B and 17 workers from plant A that not had taken part in the training were included in the control group. All workers reported physical activity (PA) by questionnaires before and after the training intervention. We measured blood pressure, heart rate, lipids, glycated hemoglobin (HbA1c), and C-reactive protein (CRP) and arterial stiffness. Maximal oxygen uptake (V̇O 2max ) was assessed by bicycle ergometry. The intervention group favorably differed significantly from the control group in improvement of systolic and diastolic blood pressure and glycated hemoglobin (HbA1c). Short training sessions with 4 min of high-intensity PA, three times a week, for eight weeks among rotating shift workers reduced some CVD risk factors. PA interventions in occupational settings may thus decrease coronary heart disease and stroke incidences in this vulnerable group of workers.",2020,The intervention group favorably differed significantly from the control group in improvement of systolic and diastolic blood pressure and glycated hemoglobin (HbA1c).,"['Rotating Shift Workers', '19 participants from plant A who had participated in at least 10 sessions', 'Sixty-five shift workers from two plants were recruited', 'From plant A, 42 workers, and plant B, 23 workers participated', 'Twenty workers from plant B and 17 workers from plant A that not had taken part in the training were included in the control group']","['High-Intensity Training', 'PA interventions']","['CVD Risk Factors', 'Maximal oxygen uptake (V̇O 2max ', 'CVD risk factors', 'blood pressure, heart rate, lipids, glycated hemoglobin (HbA1c), and C-reactive protein (CRP) and arterial stiffness', 'coronary heart disease and stroke incidences', 'physical activity (PA', 'systolic and diastolic blood pressure and glycated hemoglobin (HbA1c']","[{'cui': 'C0555009', 'cui_str': 'Rotating shift worker'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0425104', 'cui_str': 'Shift worker'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",19.0,0.0220527,The intervention group favorably differed significantly from the control group in improvement of systolic and diastolic blood pressure and glycated hemoglobin (HbA1c).,"[{'ForeName': 'Asgeir', 'Initials': 'A', 'LastName': 'Mamen', 'Affiliation': 'School of Health Sciences, Kristiania University College, Box 1190, Sentrum, 0107 Oslo, Norway.'}, {'ForeName': 'Reidun', 'Initials': 'R', 'LastName': 'Øvstebø', 'Affiliation': 'The Blood Cell Research Group, Department of Medical Biochemistry, Oslo University Hospital, 0450 Ullevaal, Norway.'}, {'ForeName': 'Per Anton', 'Initials': 'PA', 'LastName': 'Sirnes', 'Affiliation': 'Østlandske Hjertesenter, 1523 Moss, Norway.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Nielsen', 'Affiliation': 'Ringvoll BHT, 1523 Moss, Norway.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Skogstad', 'Affiliation': 'Ringvoll BHT, 1523 Moss, Norway.'}]",International journal of environmental research and public health,['10.3390/ijerph17113943']
1028,32497783,Study protocol: Using peer support to aid in prevention and treatment in prediabetes (UPSTART).,"BACKGROUND


There is an urgent need to develop and evaluate effective and scalable interventions to prevent or delay the onset of type 2 diabetes mellitus (T2DM).
METHODS


In this randomized controlled pragmatic trial, 296 adults with prediabetes will be randomized to either a peer support arm or enhanced usual care. Participants in the peer support arm meet face-to-face initially with a trained peer coach who also is a patient at the same health center to receive information on locally available wellness and diabetes prevention programs, discuss behavioral goals related to diabetes prevention, and develop an action plan for the next week to meet their goals. Over six months, peer coaches call their assigned participants weekly to provide support for weekly action steps. In the final 6 months, coaches call participants at least once monthly. Participants in the enhanced usual care arm receive information on local resources and periodic updates on available diabetes prevention programs and resources. Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed.
RESULTS


At least 296 participants and approximately 75 peer supporters will be enrolled.
DISCUSSION


Despite evidence that healthy lifestyle interventions can improve health behaviors and reduce risk for T2DM, engagement in recommended behavior change is low. This is especially true among racial and ethnic minority and low-income adults. Regular outreach and ongoing support from a peer coach may help participants to initiate and sustain healthy behavior changes to reduce their risk of diabetes.
TRIAL REGISTRATION


The ClinicalTrials.gov registration number is NCT03689530.",2020,"Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed.
","['296 adults with prediabetes', 'At least 296 participants and approximately 75 peer supporters will be enrolled']","['peer support arm or enhanced usual care', 'peer support arm meet face-to-face initially with a trained peer coach who also is a patient at the same health center to receive information on locally available wellness and diabetes prevention programs, discuss behavioral goals related to diabetes prevention, and develop an action plan']","['Changes in A1c, weight, waist circumference', 'health behaviors']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",296.0,0.0609549,"Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed.
","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America. Electronic address: mheisler@umich.edu.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kullgren', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America; Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor, MI, United States of America; University of Michigan Institute for Healthcare Policy and Innovation, Ann Arbor, MI, United States of America. Electronic address: jkullgre@med.umich.edu.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Richardson', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America. Electronic address: caroli@umich.edu.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Stoll', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America. Electronic address: scstoll@umich.edu.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Alvarado Nieves', 'Affiliation': 'University of Michigan, Department of Internal Medicine- Metabolism, Endocrinology and Diabetes, United States of America. Electronic address: alvaradc@med.umich.edu.'}, {'ForeName': 'Deanne', 'Initials': 'D', 'LastName': 'Wiley', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: deanne.wiley@kp.org.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Sedgwick', 'Affiliation': 'Kaiser Permanente Northern California Division of Research, United States of America. Electronic address: Tali.S.Sedgwick@kp.org.'}, {'ForeName': 'Alyce', 'Initials': 'A', 'LastName': 'Adams', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: Alyce.S.Adams@kp.org.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Hedderson', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: Monique.m.hedderson@kp.org.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'The Permanente Medical Group (Kaiser Permanente, Northern California), United States of America. Electronic address: Eileen.Kim@kp.org.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rao', 'Affiliation': 'The Permanente Medical Group (Kaiser Permanente, Northern California), United States of America. Electronic address: megan.rao@kp.org.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Schmittdiel', 'Affiliation': 'Kaiser Permanente Northern California Division of Research, United States of America. Electronic address: Julie.A.Schmittdiel@kp.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106048']
1029,32512364,Intake of Camelina Sativa Oil and Fatty Fish Alter the Plasma Lipid Mediator Profile in Subjects with Impaired Glucose Metabolism - A Randomized Controlled Trial.,"n-3 and n-6 polyunsaturated fatty acids (PUFAs) and their lipid mediator metabolites are associated with inflammation. We investigated the effect of dietary intake of plant- and animal-derived n-3 PUFAs and fish protein on the circulatory concentrations of lipid mediators. Seventy-nine subjects with impaired fasting glucose who completed the controlled dietary intervention after randomization to the fatty fish (FF, n=20), lean fish (LF, n=21), Camelina sativa oil (CSO, n=18) or control group (n=20) for 12 weeks were studied. Lipid mediator profiling from fasting plasma samples before and after the intervention was performed by liquid chromatography-mass spectrometry (LC-MS/MS). The FF diet increased concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE) and 4- and 17-hydroxydocosahexaenoic acid (4-, 17-HDoHE) derived from eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), respectively. Concentrations of lipid mediators derived from α-linolenic acid (ALA) increased and arachidonic acid (AA) derived 5-iso prostaglandin F 2α -VI decreased in the CSO group. There were no significant changes in lipid mediators in the LF group. The dietary intake of both plant and animal-based n-3 PUFAs increased circulatory concentrations of lipid mediators with potential anti-inflammatory properties.",2020,The FF diet increased concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE) and,"['Subjects with Impaired Glucose Metabolism ', 'Seventy-nine subjects with impaired fasting glucose who completed the controlled dietary intervention after randomization to the fatty fish (FF, n=20), lean fish (LF, n=21']","['plant- and animal-derived n-3 PUFAs and fish protein', 'Camelina sativa oil (CSO, n=18) or control group', 'Camelina Sativa Oil and Fatty Fish', 'n-3 and n-6 polyunsaturated fatty acids (PUFAs', 'plant and animal-based n-3 PUFAs', '4- and 17-hydroxydocosahexaenoic acid (4-, 17-HDoHE) derived from eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA']","['lipid mediators', 'arachidonic acid (AA) derived 5-iso prostaglandin F 2α -VI', 'concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE', 'Plasma Lipid Mediator Profile']","[{'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish'}, {'cui': 'C0016163', 'cui_str': 'Fish'}]","[{'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0598294', 'cui_str': 'Fish Proteins'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0639949', 'cui_str': '17-hydroxy-4,7,10,13,15,19-docosahexaenoic acid'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0033561', 'cui_str': 'F series prostaglandin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3251952', 'cui_str': '18(R)-hydroxyeicosapentaenoic acid'}, {'cui': 'C0019215', 'cui_str': ""N-2-Hydroxyethylpiperazine-N'-2'-ethanesulfonic Acid""}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}]",79.0,0.053379,The FF diet increased concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE) and,"[{'ForeName': 'Topi', 'Initials': 'T', 'LastName': 'Meuronen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland. Electronic address: topim@uef.fi.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Lankinen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Fauland', 'Affiliation': 'Division of Physiological Chemistry 2, Department of Medical Biochemistry and Biophysics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Bun-Ichi', 'Initials': 'BI', 'LastName': 'Shimizu', 'Affiliation': 'Division of Physiological Chemistry 2, Department of Medical Biochemistry and Biophysics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Vanessa D', 'Initials': 'VD', 'LastName': 'de Mello', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Laaksonen', 'Affiliation': 'Department of Medicine, Endocrinology and Clinical Nutrition, Kuopio University Hospital, 70029 Kuopio University Hospital, Finland; Institute of Biomedicine, Physiology, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Craig E', 'Initials': 'CE', 'LastName': 'Wheelock', 'Affiliation': 'Division of Physiological Chemistry 2, Department of Medical Biochemistry and Biophysics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Arja T', 'Initials': 'AT', 'LastName': 'Erkkilä', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Ursula S', 'Initials': 'US', 'LastName': 'Schwab', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland; Department of Medicine, Endocrinology and Clinical Nutrition, Kuopio University Hospital, 70029 Kuopio University Hospital, Finland.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2020.102143']
1030,32512477,"Effect of a maximal exercise test on serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium in athletes.","AIM


This study aims to determine the changes induced by a maximal exercise test until exhaustion on the serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr) in athletes (AG) and sedentary students (SG).
METHODS


Fifty subjects participated in the study divided into two groups. In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students. Both groups performed an exercise test until exhaustion, starting at 8 or 10 km/h respectively, and increasing the speed at 1 km/h every 400 m. Serum and urine samples were obtained from all participants before and after the test.
RESULTS


Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG. Comparing the pre and post-test values, corrected or non-corrected for hemoconcentration in serum and for creatinine in urine, AG showed a decrease in serum Mg (p < 0.05), in serum P (p < 0.01) and in urinary Sr (p < 0.01) while an increase was observed in urinary P (p < 0.05) and in urinary Rb (p < 0.05).
CONCLUSIONS


It can be concluded that a treadmill test until exhaustion leads to changes in serum and urinary concentrations of minerals in both AG and SG males. This may reflect an adaptive response of the body to overcome the physical stress and, in some cases, to avoid loss of these elements.",2020,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","['athletes', 'athletes (AG) and sedentary students (SG', 'In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students', 'Fifty subjects participated in the study divided into two groups']",['maximal exercise test'],"['urinary Rb', 'serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr', 'urinary Sr', 'serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0035930', 'cui_str': 'Rubidium'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0232827', 'cui_str': 'Urinary concentration'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0038467', 'cui_str': 'Strontium'}]",25.0,0.0207851,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Muñoz', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: diegomun@unex.es.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Grijota', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: fgrijota@gmail.com.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Siquier-Coll', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: jsiquier@alumnos.unex.es.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Toro-Román', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: vtororom@alumnos.unex.es.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Bartolomé', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: ignbs.1991@gmail.com.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Maynar-Mariño', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: mmaynar@unex.es.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126572']
1031,32506922,Exploratory Analysis of the Impact of an mHealth Medication Adherence Intervention on Tacrolimus Trough Concentration Variability: Post Hoc Results of a Randomized Controlled Trial.,"BACKGROUND


Medication nonadherence is a leading cause of late allograft loss in kidney transplantation (KT). Tacrolimus trough coefficient of variation (CV), measured using the coefficient of variation, is strongly correlated with acute rejection, graft function, and graft loss.
OBJECTIVE


The objective of this study was to determine if this mobile health (mHealth) intervention aimed at improving medication adherence in a nonadherent KT population would affect high intrapatient tacrolimus variability.
METHODS


A 6-month, prospective, parallel-arm, randomized controlled clinical trial was conducted to determine the effects of an mHealth intervention on tacrolimus CV. Intervention arm participants utilized an electronic medication tray and an mHealth app to monitor home-based adherence. Tailored motivational reinforcement messages were delivered to promote competence for adherence. Tacrolimus CV was measured using a 12-month rolling average, assessed at monthly intervals (6-month intervention period and 6 months after completion of the study); 80 were included, 40 in each arm.
RESULTS


At baseline, tacrolimus CV was similar between arms (37% ± 15% intervention, 37% ± 13% control,  P  = 0.894). Patients randomized to the intervention had a significant reduction in mean 12-month tacrolimus CVs ( P  = 0.046) and a significant improvement in the proportion achieving low tacrolimus CV (tacrolimus CV < 40%;  P  = 0.001), as compared with the control arm.
CONCLUSION AND RELEVANCE


High tacrolimus CV is a risk factor for acute rejection and graft loss; these results offer the potential promise of improved medication adherence and clinical outcomes through the use of innovative technology.",2020,"Patients randomized to the intervention had a significant reduction in mean 12-month tacrolimus CVs ( P  = 0.046) and a significant improvement in the proportion achieving low tacrolimus CV (tacrolimus CV < 40%;  P  = 0.001), as compared with the control arm.  ",['kidney transplantation (KT'],"['mHealth intervention', 'mHealth Medication Adherence Intervention', 'tacrolimus CV', 'Tacrolimus CV', 'electronic medication tray and an mHealth app to monitor home-based adherence']","['proportion achieving low tacrolimus CV', 'Tacrolimus trough coefficient of variation (CV', 'tacrolimus CV', 'mean 12-month tacrolimus CVs', 'acute rejection, graft function, and graft loss']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0184054', 'cui_str': 'Tray'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008509', 'cui_str': 'Sampling of chorionic villus'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}]",,0.159573,"Patients randomized to the intervention had a significant reduction in mean 12-month tacrolimus CVs ( P  = 0.046) and a significant improvement in the proportion achieving low tacrolimus CV (tacrolimus CV < 40%;  P  = 0.001), as compared with the control arm.  ","[{'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'McGillicuddy', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Chandler', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Luke R', 'Initials': 'LR', 'LastName': 'Sox', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Taber', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}]",The Annals of pharmacotherapy,['10.1177/1060028020931806']
1032,32505660,Frontal-midline theta frequency and probabilistic learning: A transcranial alternating current stimulation study.,"Probabilistic learning is a fundamental cognitive ability that extracts and represents regularities of our environment enabling predictive processing during perception and acquisition of perceptual, motor, cognitive, and social skills. Previous studies show competition between neural networks related to executive function/working memory vs. probabilistic learning. Theta synchronization has been associated with the former while desynchronization with the latter in correlational studies. In the present paper our aim was to test causal relationship between fronto-parietal midline theta synchronization and probabilistic learning with non-invasive transcranial alternating current (tACS) stimulation. We hypothesize that theta synchronization disrupts probabilistic learning performance by modulating the competitive relationship. Twenty-six young adults performed the Alternating Serial Reaction Time (ASRT) task to assess probabilistic learning in two sessions that took place one week apart. Stimulation was applied in a double-blind cross-over within-subject design with an active theta tACS and a sham stimulation in a counter-balanced order between participants. Sinusoidal current was administered with 1 mA peak-to-peak intensity throughout the task (approximately 20 min) for the active stimulation and 30 s for the sham. We did not find an effect of fronto-parietal midline theta tACS on probabilistic learning comparing performance during active and sham stimulation. To influence probabilistic learning, we suggest applying higher current intensity and stimulation parameters more precisely aligned to endogenous brain activity for future studies.",2020,We did not find an effect of fronto-parietal midline theta tACS on probabilistic learning comparing performance during active and sham stimulation.,['Twenty-six young adults'],"['fronto-parietal midline theta synchronization and probabilistic learning with non-invasive transcranial alternating current (tACS) stimulation', 'probabilistic learning', 'fronto-parietal midline theta tACS', 'Probabilistic learning', 'Alternating Serial Reaction Time (ASRT) task to assess probabilistic learning']",['probabilistic learning performance'],"[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}]",26.0,0.103353,We did not find an effect of fronto-parietal midline theta tACS on probabilistic learning comparing performance during active and sham stimulation.,"[{'ForeName': 'Zsófia', 'Initials': 'Z', 'LastName': 'Zavecz', 'Affiliation': 'Doctoral School of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary.'}, {'ForeName': 'Kata', 'Initials': 'K', 'LastName': 'Horváth', 'Affiliation': 'Doctoral School of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary.'}, {'ForeName': 'Péter', 'Initials': 'P', 'LastName': 'Solymosi', 'Affiliation': 'Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Janacsek', 'Affiliation': 'Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary; Centre of Thinking and Learning, Institute for Lifecourse Development, School of Human Sciences, University of Greenwich, London, United Kingdom.'}, {'ForeName': 'Dezso', 'Initials': 'D', 'LastName': 'Nemeth', 'Affiliation': 'Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary; Lyon Neuroscience Research Center (CRNL), INSERM, CNRS, Université Claude Bernard Lyon 1, Lyon, France. Electronic address: dezso.nemeth@univ-lyon1.fr.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112733']
1033,32512184,"Accelerated iTBS treatment applied to the left DLPFC in depressed patients results in a rapid volume increase in the left hippocampal dentate gyrus, not driven by brain perfusion.","BACKGROUND


Accelerated intermittent Theta Burst Stimulation (aiTBS) has been shown to be an effective antidepressant treatment. Although neurobiological changes shortly after this intervention have been reported, whether aiTBS results in structural brain changes must still be determined. Furthermore, it possible that rapid volumetric changes are driven by factors other than neurotrophic processes.
OBJECTIVES


We examined whether possible grey matter volumetric (GMV) increases after aiTBS treatment could be driven by increased brain perfusion, measured by Arterial Spin Labeling (ASL).
METHODS


46 treatment-resistant depressed patients were randomized to receive 20 sessions of active or sham iTBS applied to the left dorsolateral prefrontal cortex. All sessions were delivered over 4 days at 5 sessions per day (trial registration: http://clinicaltrials.gov/show/NCT01832805). Patients were scanned the day before starting stimulation and three days after aiTBS.
RESULTS


There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation. These GMV increases became more pronounced when accounting for changes in cerebral perfusion.
CONCLUSIONS


Active, but not sham, aiTBS, resulted in acute volumetric changes in parts of the left dentate gyrus, suggesting a connection with adult neurogenesis. Furthermore, taking cerebral perfusion measurements into account impacts on detection of the GMV changes. Whether these hippocampal volumetric changes produced by active aiTBS are necessary for long-term clinical improvement remains to be determined.",2020,"There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation.",['46 treatment-resistant depressed patients'],"['Accelerated intermittent Theta Burst Stimulation (aiTBS', '20 sessions of active or sham iTBS']","['Arterial Spin Labeling (ASL', 'left hippocampal GMV']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}]",46.0,0.102893,"There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation.","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'Ghent University, Department of Psychiatry and Medical Psychology, Ghent Experimental Psychiatry (GHEP) Lab, Ghent, Belgium; Vrije Universiteit Brussel (VUB), Department of Psychiatry, Universitair Ziekenhuis Brussel (UZBrussel), Laarbeeklaan 101, 1090, Brussels, Belgium; Eindhoven University of Technology, Department of Electrical Engineering, Eindhoven, the Netherlands.'}, {'ForeName': 'GuoRong', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Key Laboratory of Cognition and Personality, Faculty of Psychology, Southwest University, Chongqing, China. Electronic address: guorongwu@swu.edu.cn.'}, {'ForeName': 'Harold A', 'Initials': 'HA', 'LastName': 'Sackeim', 'Affiliation': 'Columbia University, Department of Psychiatry, New York, NY, USA; Columbia University, Department of Radiology, New York, NY, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.05.015']
1034,32512234,Oxygen supplementation increases the total work and muscle damage markers but reduces the inflammatory response in COPD patients.,"INTRODUCTION


Oxygen supplementation (O 2 -Suppl) is recommended for pulmonary rehabilitation with higher exercise intensities. However, high-intensity exercise tends toward muscle damage and a greater inflammatory response. We aimed to investigate the effect of O 2 -Suppl during exercise test (EET) on CRP level and muscle damage (CPK, LDH, lactate) in non-hypoxemic COPD patients.
METHODS


Eleven non-depleted patients with COPD (FEV 1  65.5 ± 4.3 %) performed two EET (room-air or O 2 -Suppl-100 %), through a blind, randomized, and placebo-controlled crossover design. CPK, LDH and CRP were measured before, immediately after and 24 h after EET.
RESULTS


Exercise time was higher with O 2 -Suppl (49.9 ± 37.3 %; p = 0.001) and increases in CPK and LDH were observed compared to basal values in the O 2 -Suppl (28.4UI/L and 28.3 UI/L). The O 2 -Suppl protocol resulted in a lower increase in CRP (92.1 ± 112.4 % vs. 400.1 ± 384.9 %; p = 0.003).
CONCLUSIONS


O 2 -Suppl increases exercise-tolerance, resulting in increased muscle injury markers in COPD. However, oxygen supplementation attenuates the inflammatory response, even upon increased physical exercise.",2020,"RESULTS


Exercise time was higher with O 2 -Suppl (49.9 ± 37.3%; p = 0.001) and increases in CPK and LDH were observed compared to basal values in the O 2 -Suppl (28.4UI/L and 28.3 UI/L).","['Eleven non-depleted patients with COPD (FEV 1  65.5\u2009±\u20094.3%) performed two EET (room-air or O 2 -Suppl-100', 'COPD patients', 'non-hypoxemic COPD patients']","['oxygen supplementation', 'Oxygen supplementation (O 2 -Suppl', 'O 2 -Suppl during exercise test (EET', 'Oxygen supplementation', 'placebo']","['Exercise time', 'CRP', 'CPK and LDH', 'CPK, LDH and CRP', 'total work and muscle damage markers', 'physical exercise', 'exercise-tolerance', 'CRP level and muscle damage (CPK, LDH, lactate', 'inflammatory response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}]",11.0,0.185322,"RESULTS


Exercise time was higher with O 2 -Suppl (49.9 ± 37.3%; p = 0.001) and increases in CPK and LDH were observed compared to basal values in the O 2 -Suppl (28.4UI/L and 28.3 UI/L).","[{'ForeName': 'Daniela Rodrigues', 'Initials': 'DR', 'LastName': 'Andrade', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Kelly Critine', 'Initials': 'KC', 'LastName': 'Pinto', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Julia Sampel', 'Initials': 'JS', 'LastName': 'de Castro', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Daniela Kuguimoto', 'Initials': 'DK', 'LastName': 'Andaku', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Viviani Aparecida', 'Initials': 'VA', 'LastName': 'Lara', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Fabio Augusto', 'Initials': 'FA', 'LastName': 'de Luca', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Gun', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Felipe Augusto Rodrigues', 'Initials': 'FAR', 'LastName': 'Mendes', 'Affiliation': 'Department of Physiotherapy, Ibirapuera University (UNIB), São Paulo, Brazil.'}, {'ForeName': 'Mayron F', 'Initials': 'MF', 'LastName': 'Oliveira', 'Affiliation': 'Pulmonary Function and Clinical Exercise Physiology Unit (SEFICE), Respiratory Division, Department of Medicine, Federal University of São Paulo (UNIFESP), São Paulo, Brazil; VO2Care Research Group, Research Physiotherapy Coordinator of Vila Nova Star Hospital, São Paulo, SP, Brazil.'}, {'ForeName': 'Wladimir Musetti', 'Initials': 'WM', 'LastName': 'Medeiros', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil; Department of Physiotherapy, Ibirapuera University (UNIB), São Paulo, Brazil; Pulmonary Function and Clinical Exercise Physiology Unit (SEFICE), Respiratory Division, Department of Medicine, Federal University of São Paulo (UNIFESP), São Paulo, Brazil; HEART - Institute of Cardiology, Department of Education and Research, São Paulo, Brazil. Electronic address: wmusettimedeiros@hotmail.com.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103475']
1035,32510976,Single-Session Bronchial Thermoplasty Guided by  129 Xe Magnetic Resonance Imaging. A Pilot Randomized Controlled Clinical Trial.,"Rationale:  Adverse events have limited the use of bronchial thermoplasty (BT) in severe asthma. Objectives:  We sought to evaluate the effectiveness and safety of using  129 Xe magnetic resonance imaging ( 129 Xe MRI) to prioritize the most involved airways for guided BT. Methods:  Thirty subjects with severe asthma were imaged with volumetric computed tomography and  129 Xe MRI to quantitate segmental ventilation defects. Subjects were randomized to treatment of the six most involved airways in the first session (guided group) or a standard three-session BT (unguided). The primary outcome was the change in Asthma Quality of Life Questionnaire score from baseline to 12 weeks after the first BT for the guided group compared with after three treatments for the unguided group. Measurements and Main Results:  There was no significant difference in quality of life after one guided compared with three unguided BTs (change in Asthma Quality of Life Questionnaire guided = 0.91 [95% confidence interval, 0.28-1.53]; unguided = 1.49 [95% confidence interval, 0.84-2.14];  P  = 0.201). After one BT, the guided group had a greater reduction in the percentage of poorly and nonventilated lung from baseline when compared with unguided (-17.2%;  P  = 0.009). Thirty-three percent experienced asthma exacerbations after one guided BT compared with 73% after three unguided BTs ( P  = 0.028). Conclusions:  Results of this pilot study suggest that similar short-term improvements can be achieved with one BT treatment guided by  129 Xe MRI when compared with standard three-treatment-session BT with fewer periprocedure adverse events.",2020,"MEASUREMENTS AND MAIN RESULTS


There was no significant difference in quality of life after one guided compared to three unguided BTs (ΔAQLQ guided= 0.91[95% CI, 0.28 to 1.53], unguided=1.49 [95% CI, 0.84 to 2.14] P=0.201).",['Thirty subjects with severe asthma were imaged with volumetric CT and 129Xe MRI to quantitate segmental ventilation defects'],"['standard three-session BT (unguided', '129 Xe Magnetic Resonance Imaging', 'Single-Session Bronchial Thermoplasty Guided by']","['quality of life', 'percent of poorly/non-ventilated lung', 'change in Asthma Quality of Life Questionnaire (AQLQ) score', 'asthma exacerbations', 'AQLQ and asthma control tests (ACT']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0860888', 'cui_str': 'Spiral computed tomography scan'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3854686', 'cui_str': 'Thermoplasty of bronchus'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205169', 'cui_str': 'Bad'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}]",30.0,0.171046,"MEASUREMENTS AND MAIN RESULTS


There was no significant difference in quality of life after one guided compared to three unguided BTs (ΔAQLQ guided= 0.91[95% CI, 0.28 to 1.53], unguided=1.49 [95% CI, 0.84 to 2.14] P=0.201).","[{'ForeName': 'Chase S', 'Initials': 'CS', 'LastName': 'Hall', 'Affiliation': 'University of Kansas School of Medicine, Kansas City, Kansas.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Quirk', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Goss', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Lew', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Kozlowski', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Thomen', 'Affiliation': 'University of Missouri, Columbia, Missouri.'}, {'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Woods', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Tustison', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, Virginia; and.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Mugler', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, Virginia; and.'}, {'ForeName': 'Lora', 'Initials': 'L', 'LastName': 'Gallagher', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Koch', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Ken B', 'Initials': 'KB', 'LastName': 'Schechtman', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Iulian C', 'Initials': 'IC', 'LastName': 'Ruset', 'Affiliation': 'Xemed LLC, Durham, New Hampshire.'}, {'ForeName': 'F William', 'Initials': 'FW', 'LastName': 'Hersman', 'Affiliation': 'Xemed LLC, Durham, New Hampshire.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'University of Kansas School of Medicine, Kansas City, Kansas.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201905-1021OC']
1036,32516149,Olanzapine for the Prevention of Postdischarge Nausea and Vomiting after Ambulatory Surgery: A Randomized Controlled Trial: Erratum.,,2020,,['after Ambulatory Surgery'],['Olanzapine'],['Postdischarge Nausea and Vomiting'],"[{'cui': 'C0002428', 'cui_str': 'Ambulatory surgery'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}]",,0.139129,,[],Anesthesiology,['10.1097/ALN.0000000000003438']
1037,32511803,Improving Outcomes Among Young Adults with type 1 diabetes: The D1 Now Randomised Pilot Study Protocol.,"BACKGROUND


Young adults (18-25 years old) living with type 1 diabetes mellitus often have sub-optimal glycaemic levels which can increase their risk of long term diabetes complications. Informed by health psychology theory and using a (public and patient involvement) young adult-centred approach, we have developed a complex intervention, entitled D1 Now, to improve outcomes in this target group. The D1 Now intervention includes three components; 1) a support-worker, 2) an interactive messaging system and 3) an agenda setting tool for use during clinic consultations.
AIMS


The aim of the D1 Now pilot study is to gather and analyse acceptability and feasibility data to allow us to (1) refine the D1 Now intervention, and (2) determine the feasibility of a definitive Randomised Control Trial (RCT) of the intervention.
METHODS


Diabetes clinics on the island of Ireland will be recruited and randomised to a D1 Now intervention arm or a usual care control arm. For a participant to be eligible they should be 18-25 years old and living with type 1 diabetes for at least 12 months. Participant outcomes (influenced by a Core Outcome Set) include change in HbA1c, clinic attendance, number of episodes of severe hypoglycaemia and of diabetic ketoacidosis, diabetes distress, self-management, quality of life and perceived level of control over diabetes; these will be will be measured at baseline and after 12 months follow-up for descriptive statistics only. An assessment of treatment fidelity, a health economic analysis and a qualitative sub-study will also be incorporated into the pilot study. ISRCTN (ref: ISRCTN74114336).",2020,"The D1 Now intervention has three components: (1) a support worker; 2) an interactive messaging system; and 3) an agenda-setting tool for use during clinic consultations.
","['Young adults (aged 18-25 years) living with type 1 diabetes mellitus', 'young adults with type 1 diabetes', 'Diabetes clinics on the island of Ireland will be recruited and randomized to a D1', 'aged 18-25 years and living with type 1 diabetes for at least 12 months']",[],"['change in HbA 1c  , clinic attendance, number of episodes of severe hypoglycaemia and of diabetic ketoacidosis, diabetes distress, self-management, quality of life and perceived level of control over diabetes']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3839636', 'cui_str': 'Diabetes clinic'}, {'cui': 'C0022130', 'cui_str': 'Island'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.094398,"The D1 Now intervention has three components: (1) a support worker; 2) an interactive messaging system; and 3) an agenda-setting tool for use during clinic consultations.
","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Casey', 'Affiliation': 'Physical Activity for Health Cluster, Health Research Institute, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Byrne', 'Affiliation': 'Health Behaviour Change Research Group, School of Psychology, NUI Galway, Galway, Ireland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Casey', 'Affiliation': 'School of Nursing & Midwifery, NUI Galway, Galway, Ireland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gillespie', 'Affiliation': 'Health Economics & Policy Analysis Centre, Centre for Research in Medical Devices, NUI Galway, Galway, Ireland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hobbins', 'Affiliation': 'Centre for Research in Medical Devices (Cúram) and Health Economics and Policy Analysis Centre (HEPAC), NUI Galway, Galway, Ireland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Newell', 'Affiliation': 'School of Mathematics, Statistics & Applied Mathematics, NUI Galway, Galway, Ireland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Morrissey', 'Affiliation': 'Health Behaviour Change Research Group, School of Psychology, NUI Galway, Galway, Ireland.'}, {'ForeName': 'S F', 'Initials': 'SF', 'LastName': 'Dinneen', 'Affiliation': 'School of Medicine, NUI Galway, Galway, Ireland.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14337']
1038,32512690,Attentiveness and Fidgeting While Using a Stand-Biased Desk in Elementary School Children.,"Standing desks are a viable option to decrease sedentary time in the classroom. However, it is important that standing desks are not detrimental to classroom behavior or learning. The purpose of this study was to evaluate the impact of stand-biased desks on fidgeting and attentiveness. Ninety-seven students in grades 3, 4, and 6 (ages 8-12 years) volunteered to participate in this study. The intervention employed a within-classroom crossover design, with teacher-determined allocation for seating within each classroom and included the replacement of one-half of the traditional sitting desks with stand-biased desks. Direct observation of student's attentive and fidgeting behaviors occurred at three assessment periods, at baseline when all students were in a sitting desk condition and at the end of each nine-week intervention. Stand-biased desks did not influence fidgeting behavior, but did have an impact on attentive behavior. Students that were less attentive at baseline had a 40-80% increase incidence rate in non-attentive behavior while in the traditional desk as compared to the stand-biased desk after the intervention. While fidgeting and non-attentive episodes ( p  = 0.034) were significantly related, the type of desk did not significantly moderate this relationship ( p  = 0.810). Standing desks can be incorporated into the classroom without negatively influencing classroom behavior.",2020,Students that were less attentive at baseline had a 40-80% increase incidence rate in non-attentive behavior while in the traditional desk as compared to the stand-biased desk after the intervention.,"['Elementary School Children', 'Ninety-seven students in grades 3, 4, and 6 (ages 8-12 years) volunteered to participate in this study']",['teacher-determined allocation for seating within each classroom and included the replacement of one-half of the traditional sitting desks with stand-biased desks'],"['Attentiveness and Fidgeting', 'sedentary time']","[{'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}]","[{'cui': 'C0233413', 'cui_str': 'Attentiveness'}, {'cui': 'C0424235', 'cui_str': 'Fidgeting'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",97.0,0.0251875,Students that were less attentive at baseline had a 40-80% increase incidence rate in non-attentive behavior while in the traditional desk as compared to the stand-biased desk after the intervention.,"[{'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Swartz', 'Affiliation': 'Department of Kinesiology, University of Wisconsin-Milwaukee, Milwaukee, WI 53201, USA.'}, {'ForeName': 'Nathan R', 'Initials': 'NR', 'LastName': 'Tokarek', 'Affiliation': 'Department of Kinesiology, University of Wisconsin-Milwaukee, Milwaukee, WI 53201, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Strath', 'Affiliation': 'Department of Kinesiology, University of Wisconsin-Milwaukee, Milwaukee, WI 53201, USA.'}, {'ForeName': 'Krista M', 'Initials': 'KM', 'LastName': 'Lisdahl', 'Affiliation': 'Department of Psychology, University of Wisconsin-Milwaukee, Milwaukee, WI 53201, USA.'}, {'ForeName': 'Chi C', 'Initials': 'CC', 'LastName': 'Cho', 'Affiliation': 'Center for Aging and Translational Research, University of Wisconsin-Milwaukee, Milwaukee, WI 53201, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17113976']
1039,32516291,Effects of dapagliflozin and gliclazide on the cardiorenal axis in people with type 2 diabetes.,"OBJECTIVES


There is a bidirectional relationship between cardiovascular and renal disease. The drug-class of SGLT2 inhibitors improves outcomes at both ends of this so called cardiorenal axis. We assessed the effects of SGLT2 inhibition and sulfonylurea treatment on systemic hemodynamic function and investigated whether SGLT2 inhibitor-induced changes in systemic hemodynamics correlate with changes in renal hemodynamics.
METHODS


Forty-four people with type 2 diabetes were randomized to 12 weeks of dapagliflozin 10 mg/day or gliclazide 30 mg/day treatment. Systemic hemodynamic function, autonomic nervous system activity, and vascular stiffness were measured noninvasively, whereas renal hemodynamics, glomerular filtration rate (GFR) and effective renal plasma flow, were assessed with gold-standard urinary clearances of inulin or iohexol and para-aminohippuric acid, respectively. Correlation analyses were performed to assess relationships between dapagliflozin-induced changes in cardiovascular and renal variables.
RESULTS


Dapagliflozin reduced stroke volume by 4%, cardiac output by 5%, vascular stiffness by 11%, and mean arterial pressure by 5% from baseline, without increasing heart rate or sympathetic activity, while simultaneously lowering glomerular filtration rate by 8%. Despite similar improvements in glycemic control by dapagliflozin and gliclazide (-0.5 ± 0.5 versus-0.7 ± 0.5%; P = 0.12), gliclazide did not affect any of these measurements. There was no clear association between the dapagliflozin-induced changes in cardiovascular and renal physiology.
CONCLUSION


Dapagliflozin seemingly influences systemic and renal hemodynamics independently and beyond glucose lowering in people with type 2 diabetes.This clinical trial was registered at https://clinicalTrials.gov (ID: NCT02682563).",2020,"RESULTS


Dapagliflozin reduced stroke volume by 4%, cardiac output by 5%, vascular stiffness by 11%, and mean arterial pressure by 5% from baseline, without increasing heart rate or sympathetic activity, while simultaneously lowering glomerular filtration rate by 8%.","['people with type 2 diabetes', 'Forty-four people with type 2 diabetes']","['gliclazide', 'dapagliflozin and gliclazide', 'dapagliflozin', 'SGLT2 inhibitors', 'SGLT2 inhibition and sulfonylurea', 'dapagliflozin 10\u200amg/day or gliclazide', 'Dapagliflozin']","['heart rate or sympathetic activity', 'cardiovascular and renal physiology', 'stroke volume', 'cardiac output', 'systemic and renal hemodynamics', 'vascular stiffness', 'mean arterial pressure', 'glomerular filtration rate', 'renal hemodynamics, glomerular filtration rate (GFR) and effective renal plasma flow', 'cardiovascular and renal variables', 'glycemic control', 'Systemic hemodynamic function, autonomic nervous system activity, and vascular stiffness']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C0017631', 'cui_str': 'Gliclazide'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C1505133', 'cui_str': 'SLC5A2 protein, human'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C3178781', 'cui_str': 'Vascular Stiffness'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0206088', 'cui_str': 'Effective renal plasma flow'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}]",44.0,0.164568,"RESULTS


Dapagliflozin reduced stroke volume by 4%, cardiac output by 5%, vascular stiffness by 11%, and mean arterial pressure by 5% from baseline, without increasing heart rate or sympathetic activity, while simultaneously lowering glomerular filtration rate by 8%.","[{'ForeName': 'Erik J M', 'Initials': 'EJM', 'LastName': 'van Bommel', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam.'}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Smits', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam.'}, {'ForeName': 'Danique', 'Initials': 'D', 'LastName': 'Ruiter', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam.'}, {'ForeName': 'Marcel H A', 'Initials': 'MHA', 'LastName': 'Muskiet', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam.'}, {'ForeName': 'Mark H H', 'Initials': 'MHH', 'LastName': 'Kramer', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Nieuwdorp', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam.'}, {'ForeName': 'Daan J', 'Initials': 'DJ', 'LastName': 'Touw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen.'}, {'ForeName': 'Jaap A', 'Initials': 'JA', 'LastName': 'Joles', 'Affiliation': 'Department of Nephrology and Hypertension, University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Daniël H', 'Initials': 'DH', 'LastName': 'van Raalte', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam.'}]",Journal of hypertension,['10.1097/HJH.0000000000002480']
1040,32516300,Improving Spatiotemporal Gait Asymmetry Has Limited Functional Benefit for Individuals Poststroke.,"BACKGROUND AND PURPOSE


Prior literature suggests a relationship between spatiotemporal gait asymmetry and metabolic cost of walking, balance, endurance, quality of life, and physical activity in people with chronic stroke. Our purpose was to determine whether targeting spatiotemporal gait symmetry would concomitantly improve these measures.
METHODS


This study represents secondary outcome measures from a trial in which 48 participants with chronic stroke were randomized to groups that all targeted spatiotemporal gait asymmetry. Measures of balance, daily step count, endurance (6-minute walk test [6MWT), metabolic cost of walking, quality of life (Stroke Impact Scale [SIS]), and overground spatiotemporal asymmetries were collected 1 week prior to and following training. Separate analyses were performed for those who trained for spatial versus temporal asymmetry. The effect of time (pre/post) was examined for all measures and correlational analyses evaluated the potential relationships between changes in spatiotemporal asymmetry and all other measures.
RESULTS


Individuals who trained to target step length asymmetry improved balance, 6MWT distance, metabolic cost of walking, and SIS-Mobility. Individuals who trained to target stance time asymmetry improved balance, 6MWT distance, SIS-Mobility, and SIS-Global recovery scores. However, step length asymmetry improvements were only related to improved 6MWT distance (P = 0.025; r = -0.49). Stance time asymmetry improvements were only related to improved metabolic cost of walking (P = 0.031; r = 0.558).
DISCUSSION AND CONCLUSIONS


Despite a targeted training approach and noted improvements in most measures, these changes did not appear to arise from improved spatiotemporal gait asymmetry. Furthermore, improvements in gait function observed in the laboratory setting did not appear to translate to increased community mobility.Video Abstract available for more insights from the authors (see the Video, Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A316).",2020,"Stance time asymmetry improvements were only related to improved metabolic cost of walking (P = 0.031; r = 0.558).
","['48 participants with chronic stroke', 'people with chronic stroke']",[],"['balance, 6MWT distance, SIS-Mobility, and SIS-Global recovery scores', 'spatiotemporal gait asymmetry and metabolic cost of walking, balance, endurance, quality of life, and physical activity', 'spatiotemporal gait asymmetry', '6MWT distance', 'metabolic cost of walking', 'community mobility', 'balance, 6MWT distance, metabolic cost of walking, and SIS-Mobility', 'gait function', 'balance, daily step count, endurance (6-minute walk test [6MWT), metabolic cost of walking, quality of life (Stroke Impact Scale [SIS]), and overground spatiotemporal asymmetries']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",48.0,0.0316495,"Stance time asymmetry improvements were only related to improved metabolic cost of walking (P = 0.031; r = 0.558).
","[{'ForeName': 'Hannah P', 'Initials': 'HP', 'LastName': 'Ryan', 'Affiliation': 'Division of Physical Therapy, Department of Allied Health Sciences, University of North Carolina at Chapel Hill, Chapel Hill.'}, {'ForeName': 'Carty', 'Initials': 'C', 'LastName': 'Husted', 'Affiliation': ''}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Lewek', 'Affiliation': ''}]",Journal of neurologic physical therapy : JNPT,['10.1097/NPT.0000000000000321']
1041,32517513,The effects of a dialogue-based intervention to promote psychosocial well-being after stroke: a randomized controlled trial.,"OBJECTIVE


To evaluate the effect of a dialogue-based intervention targeting psychosocial well-being at 12 months post-stroke.
DESIGN


Multicenter, prospective, randomized, assessor-blinded, controlled trial with two parallel groups.
SETTING


Community.
SUBJECTS


Three-hundred and twenty-two adults (⩾18 years) with stroke within the last four weeks were randomly allocated into intervention group ( n  = 166) or control group ( n  = 156).
INTERVENTIONS


The intervention group received a dialogue-based intervention to promote psychosocial well-being, comprising eight individual 1-1½ hour sessions delivered during the first six months post-stroke.
MAIN MEASURES


The primary outcome measure was the General Health Questionnaire-28 (GHQ-28). Secondary outcome measures included the Stroke and Aphasia Quality of Life Scale-39g, the Sense of Coherence scale, and the Yale Brown single-item questionnaire.
RESULTS


The mean (SD) age of the participants was 66.8 (12.1) years in the intervention group and 65.7 (13.3) years in the control group. At 12 months post-stroke, the mean (SE) GHQ-28 score was 20.6 (0.84) in the intervention group and 19.9 (0.85) in the control group. There were no between-group differences in psychosocial well-being at 12 months post-stroke (mean difference: -0.74, 95% confidence interval (CI): -3.08, 1.60). The secondary outcomes showed no statistically significant between-group difference in health-related quality of life, sense of coherence, or depression at 12 months.
CONCLUSION


The results of this trial did not demonstrate lower levels of emotional distress and anxiety or higher levels of health-related quality of life in the intervention group (dialogue-based intervention) as compared to the control group (usual care) at 12 months post-stroke.",2020,The results of this trial did not demonstrate lower levels of emotional distress and anxiety or higher levels of health-related quality of life in the intervention group (dialogue-based intervention) as compared to the control group (usual care) at 12 months post-stroke.,"['The mean (SD) age of the participants was 66.8 (12.1) years in the intervention group and 65.7 (13.3) years in the control group', 'Three-hundred and twenty-two adults (⩾18\u2009years) with stroke within the last four weeks', 'Community']","['dialogue-based intervention to promote psychosocial well-being', 'dialogue-based intervention']","['health-related quality of life, sense of coherence, or depression', 'emotional distress and anxiety or higher levels of health-related quality of life', 'Stroke and Aphasia Quality of Life Scale-39g, the Sense of Coherence scale, and the Yale Brown single-item questionnaire', 'General Health Questionnaire-28 (GHQ-28', 'mean (SE) GHQ-28 score']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517844', 'cui_str': '66.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3178983', 'cui_str': 'Salutogenesis'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",322.0,0.103993,The results of this trial did not demonstrate lower levels of emotional distress and anxiety or higher levels of health-related quality of life in the intervention group (dialogue-based intervention) as compared to the control group (usual care) at 12 months post-stroke.,"[{'ForeName': 'Line Kildal', 'Initials': 'LK', 'LastName': 'Bragstad', 'Affiliation': 'Research Center for Habilitation and Rehabilitation Services and Models (CHARM), Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Ellen Gabrielsen', 'Initials': 'EG', 'LastName': 'Hjelle', 'Affiliation': 'Research Center for Habilitation and Rehabilitation Services and Models (CHARM), Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Zucknick', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Department of Biostatistics, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Unni', 'Initials': 'U', 'LastName': 'Sveen', 'Affiliation': 'Department of Geriatric Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Thommessen', 'Affiliation': 'Department of Neurology, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Berit Arnesveen', 'Initials': 'BA', 'LastName': 'Bronken', 'Affiliation': 'Department of Health and Nursing Sciences, Faculty of Social and Health Sciences, Inland Norway University of Applied Sciences, Elverum, Norway.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Martinsen', 'Affiliation': 'Department of Health and Nursing Sciences, Faculty of Social and Health Sciences, Inland Norway University of Applied Sciences, Elverum, Norway.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Kitzmüller', 'Affiliation': 'Department of Health and Care Sciences, Faculty of Health Sciences, UiT, The Arctic University of Norway, Narvik, Norway.'}, {'ForeName': 'Margrete', 'Initials': 'M', 'LastName': 'Mangset', 'Affiliation': 'Department of Geriatric Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Kari Johanne', 'Initials': 'KJ', 'LastName': 'Kvigne', 'Affiliation': 'Department of Health and Nursing Sciences, Faculty of Social and Health Sciences, Inland Norway University of Applied Sciences, Elverum, Norway.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Hilari', 'Affiliation': 'Centre for Language and Communication Sciences Research, School of Health Sciences, City, University of London, London, UK.'}, {'ForeName': 'C Elizabeth', 'Initials': 'CE', 'LastName': 'Lightbody', 'Affiliation': 'School of Nursing, University of Central Lancashire, Lancashire, UK.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Kirkevold', 'Affiliation': 'Research Center for Habilitation and Rehabilitation Services and Models (CHARM), Institute of Health and Society, University of Oslo, Oslo, Norway.'}]",Clinical rehabilitation,['10.1177/0269215520929737']
1042,32686337,Raloxifene Prevents Early Periprosthetic Bone Loss for Postmenopausal Women after Uncemented Total Hip Arthroplasty: A Randomized Placebo-Controlled Clinical Trial.,"OBJECTIVE


To examine the results of raloxifene for prevention of periprosthetic bone loss around the femoral stem in patients undergoing total hip arthroplasty (THA).
METHODS


Between January 2015 and May 2017, 240 female patients between 55 and 80 years underwent primary THA and were randomly allocated to receive 60 mg raloxifene hydrochloride per day (treatment group, TG, n = 120) or placebo (control group, CG, n = 120) orally at bedtime using computer-generated randomization sequence generation. Baseline data, the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), women's quality of life (QoL) score, bone mineral density (BMD) around the prosthesis, and adverse events were compared between the two groups. The measuring range of BMD around the prosthesis was divided into seven regions of interest (ROI). The sample size was calculated to detect a mean difference in BMD of 0.15 g/cm 2  with a standard deviation (SD) of 0.3. The error was set at 0.05 and the power level at 90% with additional compensation for a possible dropout rate of 20%.
RESULTS


A total of 240 participants in the study up to 24 months after THA. There were no significant differences in the mean BMD of all the zones between groups before surgery (all P > 0.05). However, there were significant differences in the BMD of Gruen zones 4 and 7 between groups at 6 months postoperatively (both P < 0.05); there were significant differences in Gruen zones 1, 4, 6, and 7 at 12 months postoperatively (all P < 0.01); there were significant differences in Gruen zones 1, 2, 4, 6, and 7 at 24 months postoperatively (all P < 0.001). Patients taking raloxifene reported higher QoL scores, with better improvement in BMD in all areas except in zones 3 and 5 compared with the control group. There were no significant differences in WOMAC pain (P = 0.4045), WOMAC function (P = 0.4456) and women's QoL scores (P = 0.5983) between groups before surgery. However, WOMAC pain, WOMAC function and women's QoL score in the treatment group were significantly better at all time points (all P < 0.05). Patients in the treatment group showed no increased adverse events, including cardiac events, stroke, venous thromboembolism, and gynecological cancer (all P > 0.05), but did show decreased odds of breast cancer in comparison with those using a placebo (P = 0.0437).
CONCLUSION


Raloxifene can help inhibit bone loss around the prosthesis and improve the QoL of postmenopausal women after THA with no increased adverse events, and can even decrease the odds of breast cancer.",2020,"There were no significant differences in WOMAC pain (P = 0.4045), WOMAC function (P = 0.4456) and women's QoL scores (P = 0.5983) between groups before surgery.","['240 female patients between 55 and 80\u2009years underwent primary THA', 'Between January 2015 and May 2017', '240 participants in the study up to 24\u2009months after THA', 'Postmenopausal Women after Uncemented Total Hip Arthroplasty', 'patients undergoing total hip arthroplasty (THA']","['Placebo', 'placebo (control group, CG, n = 120) orally at bedtime using computer-generated randomization sequence generation', 'Raloxifene', 'raloxifene hydrochloride', 'raloxifene', 'placebo']","[""WOMAC pain, WOMAC function and women's QoL score"", 'bone loss', 'periprosthetic bone loss', 'Early Periprosthetic Bone Loss', ""Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), women's quality of life (QoL) score, bone mineral density (BMD) around the prosthesis, and adverse events"", 'BMD', 'odds of breast cancer', 'range of BMD', ""women's QoL scores"", 'QoL scores', 'WOMAC pain', 'adverse events, including cardiac events, stroke, venous thromboembolism, and gynecological cancer', 'adverse events', 'WOMAC function', 'BMD of Gruen zones', 'mean BMD']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0244404', 'cui_str': 'Raloxifene'}, {'cui': 'C0618111', 'cui_str': 'Raloxifene hydrochloride'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",240.0,0.0719752,"There were no significant differences in WOMAC pain (P = 0.4045), WOMAC function (P = 0.4456) and women's QoL scores (P = 0.5983) between groups before surgery.","[{'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Gong', 'Affiliation': 'Department of Orthopaedic Surgery, China-Japan Friendship Hospital, Peking Union Medical College, Chinese Academy of Medical College, Beijing, China.'}, {'ForeName': 'Yao-Yao', 'Initials': 'YY', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Bao Ding Maternal and Children Hospital, Baoding, China.'}, {'ForeName': 'Huan-Juan', 'Initials': 'HJ', 'LastName': 'Qian', 'Affiliation': 'Department of Orthopedics Surgery, 81 Group Military Hospital of Chinese PLA, Baoding, China.'}, {'ForeName': 'Ling-Kun', 'Initials': 'LK', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics Surgery, 81 Group Military Hospital of Chinese PLA, Baoding, China.'}, {'ForeName': 'Ming-Sheng', 'Initials': 'MS', 'LastName': 'Tan', 'Affiliation': 'Department of Orthopaedic Surgery, China-Japan Friendship Hospital, Peking Union Medical College, Chinese Academy of Medical College, Beijing, China.'}]",Orthopaedic surgery,['10.1111/os.12696']
1043,32512124,Placebo-induced pain reduction is associated with negative coupling between brain networks at rest.,"Placebos can reduce pain by inducing beliefs in the effectiveness of an actually inert treatment. Such top-down effects on pain typically engage lateral and medial prefrontal regions, the insula, somatosensory cortex, as well as the thalamus and brainstem during pain anticipation or perception. Considering the level of large-scale brain networks, these regions spatially align with fronto-parietal/executive control, salience, and sensory-motor networks, but it is unclear if and how placebos alter interactions between them during rest. Here, we investigated how placebo analgesia affected intrinsic network coupling. Ninety-nine human participants were randomly assigned to a placebo or control group and underwent resting-state fMRI after pain processing. Results revealed inverse coupling between two resting-state networks in placebo but not control participants. Specifically, networks comprised the bilateral somatosensory cortex and posterior insula, as well as the brainstem, thalamus, striatal regions, dorsal and rostral anterior cingulate cortex, and the anterior insula, respectively. Across participants, more negative between-network coupling was associated with lower individual pain intensity as assessed during a preceding pain task, and there was no significant relation with expectations of medication effectiveness in the placebo group. Altogether, these findings provide initial evidence that placebo analgesia affects the intrinsic communication between large-scale brain networks, even in the absence of pain. We suggest a theoretical model where placebo analgesia might affect processing within a descending pain-modulatory network, potentially segregating it from somatosensory regions that may code for painful experiences.",2020,"Across participants, more negative between-network coupling was associated with lower individual pain intensity as assessed during a preceding pain task, and there was no significant relation with expectations of medication effectiveness in the placebo group.",['Ninety-nine human participants'],"['Placebos', 'Placebo', 'placebo or control group and underwent resting-state fMRI after pain processing', 'placebo']","['individual pain intensity', 'pain reduction', 'medication effectiveness', 'pain']","[{'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0423732', 'cui_str': 'After pains'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",99.0,0.206348,"Across participants, more negative between-network coupling was associated with lower individual pain intensity as assessed during a preceding pain task, and there was no significant relation with expectations of medication effectiveness in the placebo group.","[{'ForeName': 'Isabella C', 'Initials': 'IC', 'LastName': 'Wagner', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010, Vienna, Austria. Electronic address: isabella.wagner@univie.ac.at.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Rütgen', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010, Vienna, Austria.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hummer', 'Affiliation': 'MR Centre of Excellence, Centre for Medical Physics and Biomedical Engineering, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Windischberger', 'Affiliation': 'MR Centre of Excellence, Centre for Medical Physics and Biomedical Engineering, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Lamm', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010, Vienna, Austria.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117024']
1044,32512127,"Creating while taking turns, the choice to unlocking group creative potential.","This study aimed to examine how communication modes affect creative idea generation in groups. Three communication mode conditions were created: natural (N), turn-taking (T), and electronic brainstorming (E). Participants were randomly recruited and grouped in dyads to solve one alternative uses task (AUT) in each condition, during which functional near-infrared spectroscopy (fNIRS)-based hyperscanning was used to record interpersonal neural responses. No difference was observed in AUT fluency across the three conditions, but AUT uniqueness was higher in the T condition than in the E condition. In addition, AUT uniqueness, AUT fluency, and perspective-taking behaviours increased faster in the T condition than in the other conditions. The T condition also showed higher perspective-taking behaviours than did the other conditions. Moreover, fNIRS data showed higher interpersonal brain synchronisation (IBS) increments at the right angular gyrus in the T condition than in the other conditions, which positively predicted perspective-taking behaviours between individuals during group creativity tasks. These findings indicate that when group members create together while taking turns, both creative performance and interpersonal interaction processes can be stimulated.",2020,"No difference was observed in AUT fluency across the three conditions, but AUT uniqueness was higher in the T condition than in the E condition.",[],[],"['AUT fluency, and perspective-taking behaviours', 'perspective-taking behaviours', 'interpersonal brain synchronisation (IBS', 'AUT fluency']",[],[],"[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]",,0.0212556,"No difference was observed in AUT fluency across the three conditions, but AUT uniqueness was higher in the T condition than in the E condition.","[{'ForeName': 'Kelong', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'Shanghai Key Laboratory of Brain Functional Genomics, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'Shanghai Key Laboratory of Brain Functional Genomics, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Hao', 'Affiliation': 'Shanghai Key Laboratory of Brain Functional Genomics, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China. Electronic address: nhao@psy.ecnu.edu.cn.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117025']
1045,32512353,A Randomized Controlled Trial of Transcultural Validation of Group-Based Psychosocial Intervention for Patients with Bipolar Disorder.,"Adjunctive psychosocial interventions are part of the preferred method to treat bipolar disorder (BD). This study aimed to conduct a randomized control and protocol-guided trial, in order to evaluate the feasibility and effectiveness of adjunctive group-based treatments for Chinese outpatients with BD. A single-blind trial in which 68 outpatients with BD were randomly assigned to either treatment as usual (TAU) or to an experimental group with 12 additional weekly sessions and 3 monthly booster sessions. Participants were assessed at baseline for mood condition, suicidal ideation, medication adherence, and quality of life (QoL), with follow-up assessments every 3 months over a 1-year period. The overall retention rate of this study was 89.7%. The results showed significant differences between groups for the variables evaluated, which included achieving euthymia, decrease of depression symptoms, and improvement of QoL. No improvements in medication adherence, reduction in manic symptoms, or suicidal ideation was observed. The results of this study support the transcultural validity and efficacy of group-based psychosocial intervention as anadjunct to TAU among Chinese outpatients with BD to promote improvements during the course of the illness including achieving euthymia, reducing depressive symptoms, and improving QoL.",2020,"The results showed significant differences between groups for the variables evaluated, which included achieving euthymia, decrease of depression symptoms, and improvement of QoL. No improvements in medication adherence, reduction in manic symptoms, or suicidal ideation was observed.","['68 outpatients with BD', 'Patients with Bipolar Disorder', 'Chinese outpatients with BD']","['Adjunctive psychosocial interventions', 'psychosocial intervention', 'Group-Based Psychosocial Intervention']","['mood condition, suicidal ideation, medication adherence, and quality of life (QoL', 'medication adherence, reduction in manic symptoms, or suicidal ideation', 'feasibility and effectiveness', 'depression symptoms', 'transcultural validity and efficacy', 'depressive symptoms, and improving QoL', 'overall retention rate']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",68.0,0.0479467,"The results showed significant differences between groups for the variables evaluated, which included achieving euthymia, decrease of depression symptoms, and improvement of QoL. No improvements in medication adherence, reduction in manic symptoms, or suicidal ideation was observed.","[{'ForeName': 'Chen-Ju', 'Initials': 'CJ', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Institute of Health and Welfare Policy, National Yang-Ming University.'}, {'ForeName': 'Yu-Hsin', 'Initials': 'YH', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical College, Taipei, Taiwan.'}, {'ForeName': 'Kuo-Yang', 'Initials': 'KY', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, Taiwan Adventist Hospital, Taipei, Taiwan.'}, {'ForeName': 'Shu-I', 'Initials': 'SI', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Audiology and Speech Language Pathology, MacKay Medical College, Taipei, Taiwan.'}, {'ForeName': 'Yi-Hung', 'Initials': 'YH', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hsiao-Mei', 'Initials': 'HM', 'LastName': 'Yeh', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chih-Hung', 'Initials': 'CH', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical College, Taipei, Taiwan.'}, {'ForeName': 'I-Chieh', 'Initials': 'IC', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hui-Chun', 'Initials': 'HC', 'LastName': 'Huang', 'Affiliation': 'Department of Medical Research, MacKay Memorial Hospital, Taipei, Taiwan; MacKay Junior College of Medicine, Nursing and Management, Taipei, Taiwan.'}, {'ForeName': 'Fang-Ju', 'Initials': 'FJ', 'LastName': 'Sun', 'Affiliation': 'Department of Medical Research, MacKay Memorial Hospital, Taipei, Taiwan; MacKay Junior College of Medicine, Nursing and Management, Taipei, Taiwan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'School of Medicine, Deakin University, Victoria, Australia.'}, {'ForeName': 'Shen-Ing', 'Initials': 'SI', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical College, Taipei, Taiwan; Department of Medical Research, MacKay Memorial Hospital, Taipei, Taiwan. Electronic address: maryliuyip@gmail.com.'}]",Psychiatry research,['10.1016/j.psychres.2020.113139']
1046,32513018,The effect of high-intensity versus low-level laser therapy in the management of plantar fasciitis: randomized participant blind controlled trial.,"OBJECTIVES


To evaluate and compare the efficacy of high-intensity laser therapy (HILT) and low-level laser therapy (LLLT) for plantar fasciitis.
DESIGN


A participant blind randomized controlled trial with parallel group design and an active comparator with follow-up at four weeks.
SETTINGS


Outpatient, University hospital.
SUBJECTS


Unilateral plantar fasciitis participants ( n  = 102) were randomly assigned into two groups. Recruitment period was from January 2017 to April 2019.
INTERVENTIONS


Interventions included eight sessions of laser therapy over three weeks and single session of patient education. The HILT group ( n  = 51) received HILT and the LLLT group ( n  = 51) received LLLT.
MAIN MEASURES


Primary outcomes: visual analogue scale; secondary outcomes: pressure algometry, sonography of plantar fascia thickness (time frame: baseline to three-week and four-week follow-up) and numeric rating scale (0%-100%) for opinion of participants on effect of treatment (time frame: three weeks). Data presented: mean (SD) or  n  (%).
RESULTS


There was no statistically significant difference between the groups according to visual analogue scale (pain in general reduction in three weeks: 2.57(3.45) vs. 2.88(3.28) cm), pressure algometry (pain threshold difference between healthy and affected heel reduction in three weeks: 1.80(6.39) vs. 1.77(2.85) kg) and sonography measurements (plantar fascia thickness difference between healthy and affected heel reduction in three weeks: 0.19(0.56) vs. 0.30(0.57) mm). There was a statistically significant difference between the groups in participants' opinion in favor to HILT group (efficacy of treatment better than 50%: 26(51%) vs. 37(73%)).
CONCLUSION


No statistically significant difference between groups was observed.",2020,"There was a statistically significant difference between the groups in participants' opinion in favor to HILT group (efficacy of treatment better than 50%: 26(51%) vs. 37(73%)).
","['Outpatient, University hospital', 'plantar fasciitis', 'Unilateral plantar fasciitis participants ( n \u2009=\u2009102']","['Interventions included eight sessions of laser therapy', 'LLLT', 'high-intensity versus low-level laser therapy', 'HILT and the LLLT', 'high-intensity laser therapy (HILT) and low-level laser therapy (LLLT']","['visual analogue scale (pain in general reduction', 'visual analogue scale; secondary outcomes: pressure algometry, sonography of plantar fascia thickness (time frame: baseline to three-week and four-week follow-up) and numeric rating scale', 'pressure algometry (pain threshold difference between healthy and affected heel reduction']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0149756', 'cui_str': 'Plantar fasciitis'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0332168', 'cui_str': 'Time frame'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4082109', 'cui_str': 'Three weeks'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}]",,0.152495,"There was a statistically significant difference between the groups in participants' opinion in favor to HILT group (efficacy of treatment better than 50%: 26(51%) vs. 37(73%)).
","[{'ForeName': 'Dovile', 'Initials': 'D', 'LastName': 'Naruseviciute', 'Affiliation': 'Department of Rehabilitation, The Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Raimondas', 'Initials': 'R', 'LastName': 'Kubilius', 'Affiliation': 'Department of Rehabilitation, The Lithuanian University of Health Sciences, Kaunas, Lithuania.'}]",Clinical rehabilitation,['10.1177/0269215520929073']
1047,32517117,Manipulating Self-Avatar Body Dimensions in Virtual Worlds to Complement an Internet-Delivered Intervention to Increase Physical Activity in Overweight Women.,"Virtual reality has been found to be a useful tool for positively influencing relevant psychological variables in order to increase physical activity (PA), especially in the overweight population. This study investigates the use of avatars and their physical variations to extend the effectiveness of existing interventions to promote PA. The main objective is to analyze the influence of the avatars' body dimensions on the efficacy of an Internet intervention to increase PA levels and improve other relevant variables (motivation toward PA, enjoyment, anxiety, self-efficacy, and PA goals). A total of 42 overweight women received a brief online intervention, and they were randomly assigned to one of three conditions: the ""Ideal avatar"" (IAC: participants are represented by avatars with ideal body dimensions); the ""Real avatar"" (RAC: participants are represented by avatars with participants' current body dimensions); and the ""Non avatar"" (NAC: participants are not represented by avatars). Results showed that the online intervention was effective in increasing PA practice and self-efficacy expectations. However, manipulating the body dimensions of avatars did not improve this intervention, although ideal avatars helped to reduce the anxiety experienced during PA in this population.",2020,"However, manipulating the body dimensions of avatars did not improve this intervention, although ideal avatars helped to reduce the anxiety experienced during PA in this population.","['Overweight Women', '42 overweight women']","['Internet intervention', 'Non avatar"" (NAC', 'brief online intervention', 'Ideal avatar"" (IAC: participants are represented by avatars with ideal body dimensions); the ""Real avatar"" (RAC']","['PA practice and self-efficacy expectations', 'PA levels and improve other relevant variables (motivation toward PA, enjoyment, anxiety, self-efficacy, and PA goals']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0668624', 'cui_str': 'AKT1 protein, human'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",42.0,0.0140915,"However, manipulating the body dimensions of avatars did not improve this intervention, although ideal avatars helped to reduce the anxiety experienced during PA in this population.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Navarro', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Ausiàs', 'Initials': 'A', 'LastName': 'Cebolla', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Llorens', 'Affiliation': 'Neurorehabilitation and Brain Research Group, Instituto de investigación e Innovación en Bioingenieria, Universitat Politécnica de Valencia, 46022 Valencia, Spain.'}, {'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'Borrego', 'Affiliation': 'Neurorehabilitation and Brain Research Group, Instituto de investigación e Innovación en Bioingenieria, Universitat Politécnica de Valencia, 46022 Valencia, Spain.'}, {'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Baños', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, University of Valencia, 46010 Valencia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17114045']
1048,32521299,Efficacy of buffered hypertonic seawater in different phenotypes of chronic rhinosinusitis with nasal polyps after endoscopic sinus surgery: a randomized double-blind study.,"PURPOSE


Nasal douching is commonly used as a postoperative management strategy for chronic rhinosinusitis with nasal polyps (CRSwNP). Few studies to date have compared the effectiveness of nasal douching in CRSwNP phenotypes after endoscopic sinus surgery (ESS). We evaluated the efficacy of seawater types in eosinophilic CRSwNP (ECRSwNP) and noneosinophilic CRSwNP (nonECRSwNP) after ESS.
METHODS


Patients with bilateral CRSwNP who had undergone ESS were blindly randomized to receive buffered hypertonic seawater (BHS) (n = 48) or physiological seawater (PS) (n = 45). CRSwNP patients were stratified by phenotypes (ECRSwNP and nonECRSwNP) retrospectively according to whether tissue eosinophils exceeded 10%. Follow-up evaluations were conducted at 2, 8, 16, and 24 weeks after surgery. Evaluations included the 22-item Sino-Nasal Outcome Test (SNOT-22), visual analog scale (VAS), Lund-Kennedy endoscopic score (LKES), saccharine clearance time (SCT), and adverse events.
RESULTS


All of the patients experienced significant improvements in SNOT-22 scores, VAS scores, and LKES over time. BHS resulted in better improvement of LEKS and SCT relative to PS at 8 weeks postoperatively. Mucosal edema formation was significantly reduced with less crusting among HBS recipients at 8 weeks. After stratification, only patients in the nonECRSwNP + BHS subgroup showed a significant improvement in LEKS and SCT at 8 weeks postoperatively. Side effect profiles were not significantly different among the groups.
CONCLUSIONS


BHS has a better inhibitory effect on mucosal edema and crusting during the early postoperative care period of CRSwNP. Among all of the patients, nonECRSwNP patients showed a significant improvement in LEKS and SCT at 8 weeks.",2020,"Side effect profiles were not significantly different among the groups.
","['chronic rhinosinusitis with nasal polyps after endoscopic sinus surgery', 'Patients with bilateral CRSwNP who had undergone ESS', 'chronic rhinosinusitis with nasal polyps (CRSwNP']","['buffered hypertonic seawater (BHS) (n\xa0=\xa048) or physiological seawater (PS) ', 'nonECRSwNP + BHS', 'noneosinophilic CRSwNP (nonECRSwNP', 'BHS', 'buffered hypertonic seawater']","['Mucosal edema formation', '22-item Sino-Nasal Outcome Test (SNOT-22), visual analog scale (VAS), Lund-Kennedy endoscopic score (LKES), saccharine clearance time (SCT), and adverse events', 'mucosal edema and crusting', 'LEKS and SCT relative to PS', 'LEKS and SCT', 'SNOT-22 scores, VAS scores, and LKES over time']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036499', 'cui_str': 'Sea Water'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}]","[{'cui': 'C0521481', 'cui_str': 'Mucous membrane edema'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C5197689', 'cui_str': 'Sinonasal Outcome Test'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205204', 'cui_str': 'Crust'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036499', 'cui_str': 'Sea Water'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",,0.0772097,"Side effect profiles were not significantly different among the groups.
","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Zhi-Qun', 'Initials': 'ZQ', 'LastName': 'Huang', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Luo', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Meng-Yue', 'Initials': 'MY', 'LastName': 'Li', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Jun-Hao', 'Initials': 'JH', 'LastName': 'Tu', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China. Electronic address: yjholly@email.ncu.edu.cn.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102554']
1049,32511226,"Safety and efficacy of co-administered diethylcarbamazine, albendazole and ivermectin during mass drug administration for lymphatic filariasis in Haiti: Results from a two-armed, open-label, cluster-randomized, community study.","In Haiti, 22 communes still require mass drug administration (MDA) to eliminate lymphatic filariasis (LF) as a public health problem. Several clinical trials have shown that a single oral dose of ivermectin (IVM), diethylcarbamazine (DEC) and albendazole (ALB) (IDA) is more effective than DEC plus ALB (DA) for clearing Wuchereria bancrofti microfilariae (Mf). We performed a cluster-randomized community study to compare the safety and efficacy of IDA and DA in an LF-endemic area in northern Haiti. Ten localities were randomized to receive either DA or IDA. Participants were monitored for adverse events (AE), parasite antigenemia, and microfilaremia. Antigen-positive participants were retested one year after MDA to assess treatment efficacy. Fewer participants (11.0%, 321/2917) experienced at least one AE after IDA compared to DA (17.3%, 491/2844, P<0.001). Most AEs were mild, and the three most common AEs reported were headaches, dizziness and abdominal pain. Serious AEs developed in three participants who received DA. Baseline prevalence for filarial antigenemia was 8.0% (239/3004) in IDA localities and 11.5% (344/2994) in DA localities (<0.001). Of those with positive antigenemia, 17.6% (42/239) in IDA localities and 20.9% (72/344, P = 0.25) in DA localities were microfilaremic. One year after treatment, 84% percent of persons with positive filarial antigen tests at baseline could be retested. Clearance rates for filarial antigenemia were 20.5% (41/200) after IDA versus 25.4% (74/289) after DA (P = 0.3). However, 94.4% (34/36) of IDA recipients and 75.9% (44/58) of DA recipients with baseline microfilaremia were Mf negative at the time of retest (P = 0.02). Thus, MDA with IDA was at least as well tolerated and significantly more effective for clearing Mf compared to the standard DA regimen in this study. Effective MDA coverage with IDA could accelerate the elimination of LF as a public health problem in the 22 communes that still require MDA in Haiti.",2020,Baseline prevalence for filarial antigenemia was 8.0% (239/3004) in IDA localities and 11.5% (344/2994) in DA localities (<0.001).,"['lymphatic filariasis in Haiti', 'LF-endemic area in northern Haiti']","['IDA and DA', 'ivermectin (IVM), diethylcarbamazine (DEC) and albendazole (ALB) (IDA', 'DA or IDA', 'diethylcarbamazine, albendazole and ivermectin', 'DEC plus ALB (DA']","['Clearance rates for filarial antigenemia', 'filarial antigenemia', 'Safety and efficacy', 'headaches, dizziness and abdominal pain', 'adverse events (AE), parasite antigenemia, and microfilaremia']","[{'cui': 'C0013884', 'cui_str': 'Lymphatic filariasis'}, {'cui': 'C0018510', 'cui_str': 'Haiti'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001909', 'cui_str': 'Albania'}, {'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0012191', 'cui_str': 'Diethylcarbamazine'}, {'cui': 'C0001911', 'cui_str': 'Albendazole'}]","[{'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C1621857', 'cui_str': 'Filarial worm'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}]",10.0,0.218718,Baseline prevalence for filarial antigenemia was 8.0% (239/3004) in IDA localities and 11.5% (344/2994) in DA localities (<0.001).,"[{'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Dubray', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Anita D', 'Initials': 'AD', 'LastName': 'Sircar', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Valery Madsen', 'Initials': 'VM', 'LastName': 'Beau de Rochars', 'Affiliation': 'University of Florida, Gainsville, Florida, United States of America.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Bogus', 'Affiliation': 'Washington University in St. Louis, St. Louis, Missouri, United States of America.'}, {'ForeName': 'Abdel N', 'Initials': 'AN', 'LastName': 'Direny', 'Affiliation': 'RTI International, Washington, District of Columbia, United States of America.'}, {'ForeName': 'Jean Romuald', 'Initials': 'JR', 'LastName': 'Ernest', 'Affiliation': 'IMA World Health, Port-au-Prince, Haiti.'}, {'ForeName': 'Carl R', 'Initials': 'CR', 'LastName': 'Fayette', 'Affiliation': 'IMA World Health, Port-au-Prince, Haiti.'}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Goss', 'Affiliation': 'Washington University in St. Louis, St. Louis, Missouri, United States of America.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Hast', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Kobie', 'Initials': 'K', 'LastName': ""O'Brian"", 'Affiliation': 'Washington University in St. Louis, St. Louis, Missouri, United States of America.'}, {'ForeName': 'Guy Emmanuel', 'Initials': 'GE', 'LastName': 'Pavilus', 'Affiliation': 'IMA World Health, Port-au-Prince, Haiti.'}, {'ForeName': 'Daniel Frantz', 'Initials': 'DF', 'LastName': 'Sabin', 'Affiliation': 'IMA World Health, Port-au-Prince, Haiti.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Wiegand', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Weil', 'Affiliation': 'Washington University in St. Louis, St. Louis, Missouri, United States of America.'}, {'ForeName': 'Jean Frantz', 'Initials': 'JF', 'LastName': 'Lemoine', 'Affiliation': 'Ministère de la Santé et de la Population, Port-au-Prince, Haïti.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008298']
1050,32512930,The Development and Effectiveness of a Clinical Training Violence Prevention Program for Nursing Students.,"The study aimed to develop and evaluate a violence prevention program for nursing students to improve communication self-efficacy, problem-focused coping style, emotion-focused coping style, and the ability to cope with violence. Using an eight-session violence prevention program, the study was designed as quasi experimental, with a pretest, posttest, and follow-up assessment with a nonequivalent control group. Nursing students from the fourth year of a university were selected as participants; 22 students were assigned to the experimental group and 23 to the control group. Data analysis included Chi-square, Fisher's exact test, Levene's Test, Mann-Whitney U-test, and repeated measures ANOVA. Results showed that the experimental group showed significantly higher posttest scores for the problem-focused coping style (F = 20.77,  p  < 0.001), intra-individual and interaction effects for the emotion-focused coping style (F = 12.03,  p  < 0.001), and the ability to cope with violence (U = 70,  p  < 0.001) than the control group. Thus, the workplace violence prevention program was effective for nursing students.",2020,"Results showed that the experimental group showed significantly higher posttest scores for the problem-focused coping style (F = 20.77,  p  < 0.001), intra-individual and interaction effects for the emotion-focused coping style (F = 12.03,  p  < 0.001), and the ability to cope with violence (U = 70,  p  < 0.001) than the control group.","['Nursing students from the fourth year of a university were selected as participants; 22 students', 'nursing students', 'Nursing Students']","['Clinical Training Violence Prevention Program', 'workplace violence prevention program', 'violence prevention program']","['coping style', ""Chi-square, Fisher's exact test, Levene's Test, Mann-Whitney U-test, and repeated measures ANOVA"", 'ability to cope with violence', 'intra-individual and interaction effects for the emotion-focused coping style']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0150215', 'cui_str': 'Violence prevention'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3658335', 'cui_str': 'Workplace Violence'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0376586', 'cui_str': 'Life-Breath (Philosophy)'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0325045', 'cui_str': 'Martes pennanti'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0242927', 'cui_str': 'Mann-Whitney U Test'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0002780', 'cui_str': 'Analysis, Variance'}, {'cui': 'C0424097', 'cui_str': 'Ability to cope'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]",22.0,0.0137831,"Results showed that the experimental group showed significantly higher posttest scores for the problem-focused coping style (F = 20.77,  p  < 0.001), intra-individual and interaction effects for the emotion-focused coping style (F = 12.03,  p  < 0.001), and the ability to cope with violence (U = 70,  p  < 0.001) than the control group.","[{'ForeName': 'Yunhwa', 'Initials': 'Y', 'LastName': 'Jeong', 'Affiliation': 'Department of Nursing and Kyongbuk Science College, Gyeongsangbuk-do 39913, Korea.'}, {'ForeName': 'Kyunghee', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Keimyung University, Daegu 42601, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17114004']
1051,32517382,Post-Exercise Recovery of Ultra-Short-Term Heart Rate Variability after Yo-Yo Intermittent Recovery Test and Repeated Sprint Ability Test.,"This study aimed to examine the agreement and acceptance of ultra-short-term heart rate (HR) variability (HRV UST ) measures during post-exercise recovery in college football players. Twenty-five male college football players (age: 19.80 ± 1.08 years) from the first division of national university championship voluntarily participated in the study. The participants completed both a repeated sprint ability test (RSA) and a Yo-Yo intermittent recovery test level 1 (YYIR1) in a randomized order and separated by 7 days. Electrocardiographic signals (ECG) were recorded in a supine position 10 min before and 30 min after the exercise protocols. The HR and HRV data were analyzed in the time segments of baseline 5~10 min (Baseline), post-exercise 0~5 min (Post 1), post-exercise 5~10 min (Post 2), and post-exercise 25~30 min (Post 3). The natural logarithm of the standard deviation of normal-to-normal intervals (LnSDNN), root mean square of successive normal-to-normal interval differences (LnRMSSD), and LnSDNN:LnRMSSD ratio was compared in the 1st min HRV UST  and 5-min criterion (HRV criterion ) of each time segment. The correlation of time-domain HRV variables to 5-min natural logarithm of low frequency power (LnLF) and high frequency power (LnHF), and LF:HF ratio were calculated. The results showed that the HRV UST  of LnSDNN, LnRMSSD, and LnSDNN:LnRMSSD ratio showed trivial to small effect sizes (ES) (-0.00~0.49), very large and nearly perfect interclass correlation coefficients (ICC) (0.74~0.95), and relatively small values of bias (RSA: 0.01~-0.12; YYIR1: -0.01~-0.16) to the HRV criterion  in both exercise protocols. In addition, the HRV UST  of LnLF, LnHF, and LnLF:LnHF showed trivial to small ES (-0.04~-0.54), small to large ICC (-0.02~0.68), and relatively small values of bias (RSA: -0.02~0.65; YYIR1: 0.03~-0.23) to the HRV criterion  in both exercise protocols. Lastly, the 1-min LnSDNN:LnRMSSD ratio was significantly correlated to the 5-min LnLF:LnHF ratio with moderate~high level ( r  = 0.43~0.72;  p  < 0.05) during 30-min post-exercise recovery. The post-exercise 1-min HRV assessment in LnSDNN, LnRMSSD, and LnSDNN:LnRMSSD ratio was acceptable and accurate in the RSA and YYIR1 tests, compared to the 5-min time segment of measurement. The moderate to high correlation coefficient of the HRV UST  LnSDNN:LnRMSSD ratio to the HRV criterion  LnLF:LnHF ratio indicated the capacity to facilitate the post-exercise shortening duration of HRV measurement after maximal anaerobic or aerobic shuttle running. Using ultra-short-term record of LnSDNN:LnRMSSD ratio as a surrogate for standard measure of LnLF:LnHF ratio after short-term bouts of maximal intensity field-based shuttle running is warranted.",2020,"The natural logarithm of the standard deviation of normal-to-normal intervals (LnSDNN), root mean square of successive normal-to-normal interval differences (LnRMSSD), and LnSDNN:LnRMSSD ratio was compared in the 1st min HRV UST  and 5-min criterion (HRV criterion ) of each time segment.","['college football players', 'Twenty-five male college football players (age: 19.80 ± 1.08 years) from the first division of national university championship voluntarily participated in the study']",['repeated sprint ability test (RSA) and a Yo-Yo intermittent recovery test level 1 (YYIR1'],"['natural logarithm of the standard deviation of normal-to-normal intervals (LnSDNN), root mean square of successive normal-to-normal interval differences (LnRMSSD), and LnSDNN:LnRMSSD ratio', 'Electrocardiographic signals (ECG', 'agreement and acceptance of ultra-short-term heart rate (HR) variability', 'HRV UST ) measures', 'HR and HRV data', 'time-domain HRV variables to 5-min natural logarithm of low frequency power (LnLF) and high frequency power (LnHF), and LF:HF ratio']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517489', 'cui_str': '1.08'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}]","[{'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}]",25.0,0.0701879,"The natural logarithm of the standard deviation of normal-to-normal intervals (LnSDNN), root mean square of successive normal-to-normal interval differences (LnRMSSD), and LnSDNN:LnRMSSD ratio was compared in the 1st min HRV UST  and 5-min criterion (HRV criterion ) of each time segment.","[{'ForeName': 'Chin-Hwai', 'Initials': 'CH', 'LastName': 'Hung', 'Affiliation': 'Physical Education Office, Fu Jen Catholic University, New Taipei City 24205, Taiwan.'}, {'ForeName': 'Filipe Manuel', 'Initials': 'FM', 'LastName': 'Clemente', 'Affiliation': ""Escola Superior Desporto e Lazer, Instituto Politécnico de Viana do Castelo, Rua Escola Industrial e Comercial de Nun'Álvares, 4900-347 Viana do Castelo, Portugal.""}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Bezerra', 'Affiliation': ""Escola Superior Desporto e Lazer, Instituto Politécnico de Viana do Castelo, Rua Escola Industrial e Comercial de Nun'Álvares, 4900-347 Viana do Castelo, Portugal.""}, {'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Chiu', 'Affiliation': 'Physical Education Office, Fu Jen Catholic University, New Taipei City 24205, Taiwan.'}, {'ForeName': 'Chia-Hua', 'Initials': 'CH', 'LastName': 'Chien', 'Affiliation': 'Department of Exercise and Health Sciences, University of Taipei, Taipei 11153, Taiwan.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Crowley-McHattan', 'Affiliation': 'School of Health and Human Sciences, Southern Cross University, Lismore 2480, Australia.'}, {'ForeName': 'Yung-Sheng', 'Initials': 'YS', 'LastName': 'Chen', 'Affiliation': 'Department of Exercise and Health Sciences, University of Taipei, Taipei 11153, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17114070']
1052,32521448,Design cues for tobacco communication: Heuristic interpretations and usability of online health information about harmful chemicals.,"OBJECTIVE


Many people have a poor understanding of the numerous chemicals in tobacco products that cause severe health harms. The US government must display a list of these harmful chemicals for the public. Online disclosures are one promising solution, but evidence is needed for effective design strategies to encourage interpretation and use of information as intended.
METHOD


To examine the impact of website designs for the activation of heuristics and usability perceptions, a national probability sample of US adolescents and adults (n = 1441) was randomized in a 3 (chemical format) × 2 (webpage layout) between-subjects online experiment. Chemicals were displayed as names only, with a visual risk indicator, or with numerical ranges. Layouts displayed health harms at the top of the webpage separate from chemicals or the chemicals grouped by associated health harms. Participants viewed a webpage and reported activated heuristics, usability (perceived ease of use and usefulness), and intentions to use the website.
RESULTS


Displaying risk indicators increased website usability by encouraging users to rely on colors to interpret the risk of the chemicals (all p < .01). Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
CONCLUSION


Assessing heuristics gives insights for how US adolescents and adults interpret chemical information and the impact of design strategies on usability. Public disclosures of chemicals in tobacco products could be optimized with color-coded risk indicators and layouts placing chemicals near the harms they cause.",2020,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
",['US adolescents and adults (n = 1441'],[],['website usability'],"[{'cui': 'C0002838', 'cui_str': 'Andorra'}]",[],[],1441.0,0.0625486,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
","[{'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Lazard', 'Affiliation': 'School of Media and Journalism, University of North Carolina at Chapel Hill, NC 27599-3365, United States; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, NC 27599-3365, United States. Electronic address: lazard@unc.edu.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104177']
1053,32526153,"Compared to conventional physiotherapy, does the use of an ankle trainer device after Weber B ankle fracture operation improve outcome and shorten hospital stay? A randomized controlled trial.","OBJECTIVE


To compare the functional outcomes and length of hospital stay for patients treated with conventional physiotherapy compared to a new ankle trainer device after Weber B ankle fractures.
DESIGN


The patients were randomized, and then followed up at 3, 6, 12 and 52 weeks by a blinded physiotherapist.
SETTING


This study was done at a level 1 trauma centre.
SUBJECTS


One hundred and forty consecutive patients with Weber B ankle fractures that were operated on were screened for eligibility, of whom 113 were included in the study.
INTERVENTIONS


Conventional physiotherapy with stretching exercises, using a non-elastic band or using new ankle trainer.
MAIN MEASURES


Outcomes were evaluated with Olerud-Molander ankle score, Visual analogue scale for pain and ankle dorsiflexion at 3, 6, 12 and 52 weeks follow-up. Time of hospitalization and complications were registered.
RESULTS


Superior Olerud-Molander ankle scores were observed at three weeks follow-up in the ankle trainer group 40.9 (10.8), compared to the conventional group 35.3 (14.2) ( P  = 0.021). At one-year follow-up, there was no difference between the groups ( P  = 0.386). The ankle trainer group had a shorter hospital stay with a mean 2.6 days (0.98) compared to 3.2 days (1.47) in the conventional group ( P  = 0.026).
CONCLUSION


The patients who were treated with the new ankle trainer device recovered more rapidly, evaluated by the Olerud-Molander ankle score and had a shorter stay in hospital compared to the conventional physiotherapy group. No between group differences could be observed at long-term follow-up.",2020,"RESULTS


Superior Olerud-Molander ankle scores were observed at three weeks follow-up in the ankle trainer group 40.9 (10.8), compared to the conventional group 35.3 (14.2) ( P  = 0.021).","['patients treated with', 'One hundred and forty consecutive patients with Weber B ankle fractures that were operated on were screened for eligibility, of whom 113 were included in the study']","['Conventional physiotherapy with stretching exercises, using a non-elastic band or using new ankle trainer', 'conventional physiotherapy']","['Time of hospitalization and complications', 'shorter hospital stay', 'Superior Olerud-Molander ankle scores', 'Olerud-Molander ankle score, Visual analogue scale for pain and ankle dorsiflexion', 'functional outcomes and length of hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0582525', 'cui_str': 'weber'}, {'cui': 'C0159877', 'cui_str': 'Fracture of ankle'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",140.0,0.117407,"RESULTS


Superior Olerud-Molander ankle scores were observed at three weeks follow-up in the ankle trainer group 40.9 (10.8), compared to the conventional group 35.3 (14.2) ( P  = 0.021).","[{'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Molund', 'Affiliation': 'Department of Orthopaedic, Sykehuset Østfold HF, Grålum, Norway.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hellesnes', 'Affiliation': 'Department of Orthopaedic, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Gøran', 'Initials': 'G', 'LastName': 'Berdal', 'Affiliation': 'Department of Orthopaedic, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Bernt Stray', 'Initials': 'BS', 'LastName': 'Andreassen', 'Affiliation': 'Department of Orthopaedic, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Geir Stray', 'Initials': 'GS', 'LastName': 'Andreassen', 'Affiliation': 'Department of Orthopaedic, Oslo University Hospital, Oslo, Norway.'}]",Clinical rehabilitation,['10.1177/0269215520929727']
1054,32511110,Effectiveness of a Home-Based Telehealth Exercise Training Program for Patients With Cardiometabolic Multimorbidity: A Randomized Controlled Trial.,"BACKGROUND


Exercise training has positive effects on the management of cardiometabolic conditions. Little is known about the effectiveness of home-based telehealth exercise training programs among patients with cardiometabolic multimorbidity, which is associated with functional decline and decreased health-related quality of life.
OBJECTIVE


The aim of this study was to determine the effectiveness of a 12-week home-based telehealth exercise training program designed to increase physical activity and exercise capacity and improve health-related quality of life in patients with cardiometabolic multimorbidity.
METHODS


A randomized controlled trial was conducted. Fifty eligible patients with 2 or more cardiometabolic conditions from outpatient clinics of a medical center in Northern Taiwan were randomized to either an experimental group (EG; received a 12-week home-based telehealth exercise training program) or a control group (CG; maintained usual lifestyles). The home-based telehealth exercise training program consisted of 36 individualized home-based exercise training sessions and a weekly reminder for maintenance of exercise and providing patient support. Amounts of physical activity, exercise capacity, and health-related quality of life were assessed at baseline and 12 weeks. Generalized estimating equations were used to examine the intervention effects via the interaction of time and group.
RESULTS


The EG had higher amounts of physical activity (β = 1333, P = .004) and moderate-intensity physical activity (β = 330, P = .04) than the CG after the intervention. The EG had increased exercise capacity (VO2peak, β = 4.43, P = .04), as well as improved health-related quality of life (physical function, β = 7.55, P = .03; and physical component summary, β = 4.42, P = .03) compared with those in the CG.
CONCLUSIONS


A 12-week home-based telehealth exercise training program is feasible and effective in increasing amounts of physical activity, elevating exercise capacity, and improving health-related quality of life in patients with cardiometabolic multimorbidity.",2020,"The EG had increased exercise capacity (VO2peak, β = 4.43, P = .04), as well as improved health-related quality of life (physical function, β = 7.55, P = .03; and physical component summary, β = 4.42, P = .03) compared with those in the CG.
","['Fifty eligible patients with 2 or more cardiometabolic conditions from outpatient clinics of a medical center in Northern Taiwan', 'Patients With Cardiometabolic Multimorbidity', 'patients with cardiometabolic multimorbidity']","['home-based telehealth exercise training program', 'Exercise training', '36 individualized home-based exercise training sessions and a weekly reminder for maintenance of exercise and providing patient support', 'experimental group (EG; received a 12-week home-based telehealth exercise training program) or a control group (CG; maintained usual lifestyles', 'Home-Based Telehealth Exercise Training Program']","['physical activity, exercise capacity, and health-related quality of life', 'physical activity and exercise capacity and improve health-related quality of life', 'exercise capacity', 'physical activity', 'moderate-intensity physical activity', 'improved health-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",50.0,0.0281242,"The EG had increased exercise capacity (VO2peak, β = 4.43, P = .04), as well as improved health-related quality of life (physical function, β = 7.55, P = .03; and physical component summary, β = 4.42, P = .03) compared with those in the CG.
","[{'ForeName': 'Shang-Lin', 'Initials': 'SL', 'LastName': 'Chiang', 'Affiliation': 'Shang-Lin Chiang, MD, PhD Assistant Professor, Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC. Chien-Lung Shen, PhD Director, Taiwan Textile Research Institute, Taipei, Taiwan, ROC. Liang-Cheng Chen, MD Professor, Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC. Yi-Pang Lo, RN, MSN Assistant Head Nurse, Department of Nursing, Songshan Branch of Tri-Service General Hospital, Taipei, Taiwan, ROC. Chueh-Ho Lin, PT, PhD Assistant Professor, Master Program in Long-Term Care, Taipei Medical University; Center for Nursing and Healthcare Research in Clinical Practice Application, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan, ROC. Chia-Huei Lin, RN, PhD Assistant Professor, School of Nursing, National Defense Medical Center, and Supervisor, Department of Nursing, Songshan Branch of Tri-Service General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Chien-Lung', 'Initials': 'CL', 'LastName': 'Shen', 'Affiliation': ''}, {'ForeName': 'Liang-Cheng', 'Initials': 'LC', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Yi-Pang', 'Initials': 'YP', 'LastName': 'Lo', 'Affiliation': ''}, {'ForeName': 'Chueh-Ho', 'Initials': 'CH', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Chia-Huei', 'Initials': 'CH', 'LastName': 'Lin', 'Affiliation': ''}]",The Journal of cardiovascular nursing,['10.1097/JCN.0000000000000693']
1055,32517165,When Do Good Deeds Lead to Good Feelings? Eudaimonic Orientation Moderates the Happiness Benefits of Prosocial Behavior.,"Engaging in prosocial behavior is considered an effective way to increase happiness in a sustainable manner. However, there is insufficient knowledge about the conditions under which such a happiness effect occurs. From a person-activity congruence perspective, we proposed that an individual's eudaimonic orientation moderates the effect of prosocial behavior on happiness, whereas hedonic orientation does not. For this purpose, 128 participants were assigned to play a game in which half of them were explained the benevolence impact of playing the game (the benevolence condition), and the other half played the same game without this knowledge (the control condition). Participants' eudaimonic and hedonic orientations were assessed before the game, and their post-task happiness were measured after the game. The results showed that participants in the benevolence condition reported higher post-task positive affect than those in the control condition. Furthermore, this happiness effect was moderated by participants' eudaimonic orientation-participants with high eudaimonic orientation reaped greater benefits from benevolence, and their hedonic orientation did not moderate the relationship between benevolence and happiness. The importance of the effect of person-activity congruence on happiness is discussed, along with the implications of these findings for sustainably pursuing happiness.",2020,The results showed that participants in the benevolence condition reported higher post-task positive affect than those in the control condition.,['128 participants'],[],"['eudaimonic and hedonic orientations', 'higher post-task positive affect']",[],[],"[{'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",128.0,0.0317442,The results showed that participants in the benevolence condition reported higher post-task positive affect than those in the control condition.,"[{'ForeName': 'Weipeng', 'Initials': 'W', 'LastName': 'Lai', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou 310058, China.'}, {'ForeName': 'Zhixu', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou 310058, China.'}, {'ForeName': 'Yanhui', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou 310058, China.'}, {'ForeName': 'Qionghan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou 310058, China.'}, {'ForeName': 'Hezhi', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou 310058, China.'}, {'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou 310058, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17114053']
1056,32519431,Optimizing patient expectations to improve therapeutic response to medical treatment: A randomized controlled trial of iron infusion therapy.,"OBJECTIVES


Patient expectations have the ability to influence health outcomes and have been shown to play an important role as part of the placebo effect to influence the response to medical treatments. Increasing positive expectations have been proposed as an intervention to improve treatment response, although evidence for this to date is limited. We investigated whether a brief 10-min intervention directly targeting patient expectations prior to an iron infusion could enhance expectations and improve treatment response, in terms of patients' reported fatigue.
DESIGN


Randomized controlled trial.
METHODS


Forty-three patients diagnosed with iron deficiency anaemia were randomized to a brief expectation intervention or active control group prior to an intravenous iron infusion. Chalder Fatigue Scale scores were assessed prior to randomization and at one and four weeks.
RESULTS


The expectation intervention significantly improved patients' expectations about the effectiveness of the intravenous iron infusion, t(21) = -3.95, p = .001. While there were no significant differences between groups in fatigue at the one-week follow-up, fatigue was significantly lower in the intervention group at the four-week follow-up compared to the control group, F(1, 25) = 6.25, p = .019. This was largely influenced by a significant reduction in physical, as opposed to mental fatigue scores.
CONCLUSIONS


Boosting patients' positive expectations may be an effective way of enhancing patient response to treatment. In particular, targeting patient expectations with a brief intervention prior to medical treatments may result in a greater and longer therapeutic effect.",2020,"While there were no significant differences between groups in fatigue at the one-week follow-up, fatigue was significantly lower in the intervention group at the four-week follow-up compared to the control group, F(1, 25) = 6.25, p = .019.",['Forty-three patients diagnosed with iron deficiency anaemia'],['brief expectation intervention or active control group prior to an intravenous iron infusion'],"['Chalder Fatigue Scale scores', 'fatigue']","[{'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",43.0,0.104222,"While there were no significant differences between groups in fatigue at the one-week follow-up, fatigue was significantly lower in the intervention group at the four-week follow-up compared to the control group, F(1, 25) = 6.25, p = .019.","[{'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Akroyd', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, New Zealand.'}, {'ForeName': 'Kerry N', 'Initials': 'KN', 'LastName': 'Gunn', 'Affiliation': 'Department of Anaesthesia, Auckland City Hospital, New Zealand.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rankin', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, New Zealand.'}, {'ForeName': 'Meihana', 'Initials': 'M', 'LastName': 'Douglas', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, New Zealand.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kleinstäuber', 'Affiliation': 'Department of Psychological Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Rief', 'Affiliation': 'Division of Clinical Psychology, University of Marburg, Germany.'}, {'ForeName': 'Keith J', 'Initials': 'KJ', 'LastName': 'Petrie', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, New Zealand.'}]",British journal of health psychology,['10.1111/bjhp.12435']
1057,32520718,Dose-Response Relationship of a Web-Based Tailored Intervention Promoting Human Papillomavirus Vaccination: Process Evaluation of a Randomized Controlled Trial.,"BACKGROUND


In the Netherlands, human papillomavirus (HPV) vaccination uptake remains low. To improve informed decision making (IDM) and HPV vaccination acceptability, we systematically developed an interactive, web-based tailored intervention to which mothers of Dutch girls were invited to participate.
OBJECTIVE


The aim of this study was to provide insight into the intervention's working mechanisms by evaluating (1) program use, (2) program acceptability, and (3) the relationship of program use with program acceptability and intervention effects (ie, dose-response relationship).
METHODS


Only mothers from the intervention arm of a randomized controlled trial that assessed the effectiveness of the web-based, tailored intervention were included in this study. They were invited to visit the website of the web-based intervention between baseline (January 2015, just before access to the intervention) and follow up (March 2015, prior to the first HPV vaccination). Indicators for program use were time of website use (ie, duration of intervention exposure) and completeness (ie, proportion of all available web pages visited). HPV vaccination uptake registered by Praeventis was used as the primary outcome. Secondary outcomes were IDM, decisional conflict, and social-psychological determinants of HPV vaccination uptake.
RESULTS


Among the 3995 invited mothers, 2509 (62.80%) logged on to the website, 2239 of whom (89.24%) visited at least one page of the intervention components. On average, mothers spent 21.39 minutes (SD 12.41) on the website and completed 50.04% (SD 26.18%) of the website components. Participants rated the website 7.64 (SD 1.39) on a 10-point scale. Program acceptability was significantly associated with completeness (β=4.36, P<.001), but not with time of website use (β=-.07, P=.77). Intention-to-treat analysis (N=3995) showed a significant positive effect of completeness on all outcome measures (all P<.003; Bonferroni-corrected α=.05/15 factors), including on HPV vaccination uptake. Time of website use had a significant positive effect on all outcomes (all P<.003), except for uptake (P=.20), risk perception when not vaccinated (P=.14), subjective norms (P=.03), and habit (P=.01).
CONCLUSIONS


Program use and acceptability of the intervention were adequate. Completeness was positively associated with acceptability. Furthermore, positive effects (ie, dose-response effects) were found for completeness and time of website use on the mothers' IDM, decisional conflict, and almost all of the social-psychological determinants of HPV vaccination acceptability. In addition, the extent to which mothers completed the intervention had a positive impact on their daughters' vaccination uptake. This indicates that the web-based, tailored intervention fits well with the mothers' needs, and that completeness of use is essential for improving HPV vaccination uptake, acceptability, and IDM. Program use should therefore be promoted.
TRIAL REGISTRATION


Netherlands Trial Register NTR4795; https://www.trialregister.nl/trial/4795.",2020,"Time of website use had a significant positive effect on all outcomes (P's <.003), except for uptake (P = .195), risk perception when not vaccinated (P = .144), subjective norms (P = .032), and habit (P = .013).
","['mothers of Dutch girls to-be-invited', '3995 invited mothers, 2509 mothers (62.80%) logged in', '2239 mothers (89.24%) visited at least one page of the intervention components']",[],"['decision-making (IDM), decisional conflict, and social psychological determinants of HPV vaccination uptake', 'Program acceptability', 'risk perception', 'HPV vaccination uptake', 'HPV vaccination uptake, acceptability, and IDM', 'completeness and time of website use on the mothers IDM, decisional conflict, and almost all of the social-psychological determinants of HPV vaccination acceptability', 'subjective norms']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013862', 'cui_str': 'Polyacrylamide gel electrophoresis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",[],"[{'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}]",3995.0,0.0847614,"Time of website use had a significant positive effect on all outcomes (P's <.003), except for uptake (P = .195), risk perception when not vaccinated (P = .144), subjective norms (P = .032), and habit (P = .013).
","[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Pot', 'Affiliation': 'Child Health, Netherlands Organization for Applied Scientific Research (TNO), Leiden, Netherlands.'}, {'ForeName': 'Theo Gwm', 'Initials': 'TG', 'LastName': 'Paulussen', 'Affiliation': 'Child Health, Netherlands Organization for Applied Scientific Research (TNO), Leiden, Netherlands.'}, {'ForeName': 'Robert Ac', 'Initials': 'RA', 'LastName': 'Ruiter', 'Affiliation': 'Department of Work and Social Psychology, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Mollema', 'Affiliation': 'National Institute for Public Health and the Environment (RIVM), Centre for Infectious Disease Control, Bilthoven, Netherlands.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Hofstra', 'Affiliation': 'Child Health, Netherlands Organization for Applied Scientific Research (TNO), Leiden, Netherlands.'}, {'ForeName': 'Hilde M', 'Initials': 'HM', 'LastName': 'Van Keulen', 'Affiliation': 'Child Health, Netherlands Organization for Applied Scientific Research (TNO), Leiden, Netherlands.'}]",Journal of medical Internet research,['10.2196/14822']
1058,32520816,The Effects of a Pain Psychology and Neuroscience Self-Evaluation Internet Intervention: A Randomized Controlled Trial.,"OBJECTIVES


Many patients' chronic musculoskeletal pain is strongly influenced by central nervous system processes such as sensitization or amplification. Education about pain neuroscience can change patients' beliefs but has less consistent effects on pain outcomes. Patients may have greater clinical benefits if the educational intervention is personalized, and they evaluate various psychosocial risk factors with respect to their pain. We developed and tested a brief, internet-based Pain Psychology and Neuroscience (PPN) self-evaluation intervention.
MATERIALS AND METHODS


From a patient registry, 104 adults reporting chronic musculoskeletal pain were randomized to the PPN intervention or a matched, active, education control condition. At baseline and 1-month (primary endpoint) and 10-month follow-ups, participants reported pain severity (primary outcome) and multiple secondary outcomes. Primary analyses compared the 2 experimental conditions using analyses of covariances; post hoc exploratory analyses compared the effects of PPN in subgroups of patients who met criteria for fibromyalgia (FM; n=50) or who did not (n=54; primarily spinal pain).
RESULTS


At 1-month follow-up, compared with the control condition, PPN led to significantly lower pain severity (ηp =0.05) and interference (ηp =0.04), greater brain (ηp =0.07) and psychological (ηp =0.07) attributions for pain, and greater readiness for pain self-management (ηp =0.08). Effects on distress, pain catastrophizing, kinesiophobia, and life satisfaction were not significant. Exploratory analyses showed that the PPN intervention was especially beneficial for patients without FM but was of less benefit for those with FM. Most of the effects (except attributions) were lost at 10 months.
DISCUSSION


A brief PPN self-evaluation intervention, presented on-line, can yield short-term improvements in musculoskeletal pain severity and interference, especially for people with spinal/localized pain rather than FM, perhaps because the psychology/neuroscience perspective is more novel for such patients.",2020,"At 1-month follow-up, compared to the control condition, PPN led to significantly lower pain severity (ηp=0.05) and interference (ηp=0.04), greater brain (ηp=0.07) and psychological (ηp=0.07) attributions for pain, and greater readiness for pain self-management (ηp=0.08).","['104 adults reporting chronic musculoskeletal pain', ""patients' chronic musculoskeletal pain"", 'From a patient registry']","['internet-based Pain Psychology and Neuroscience (PPN) self-evaluation intervention', 'PPN intervention or a matched, active, education control condition', 'PPN intervention', 'Pain Psychology and Neuroscience Self-Evaluation Internet Intervention', 'PPN']","['pain outcomes', 'pain severity (ηp=0.05) and interference (ηp=0.04), greater brain (ηp=0.07) and psychological (ηp=0.07) attributions for pain, and greater readiness for pain self-management', 'distress, pain catastrophizing, kinesiophobia, and life satisfaction', 'pain severity']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",104.0,0.06102,"At 1-month follow-up, compared to the control condition, PPN led to significantly lower pain severity (ηp=0.05) and interference (ηp=0.04), greater brain (ηp=0.07) and psychological (ηp=0.07) attributions for pain, and greater readiness for pain self-management (ηp=0.08).","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kohns', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Michigan Health System, Ann Arbor.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Urbanik', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Geisser', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Michigan Health System, Ann Arbor.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Schubiner', 'Affiliation': 'Department of Internal Medicine, Ascension Providence Hospital and Michigan State University, Southfield, MI.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Lumley', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000857']
1059,32522591,Mothers' DASH diet adherence and food purchases after week-long episodic future thinking intervention.,"Prospection has helped participants forego the temptation to buy and eat higher calorie nutrient poor foods in favor of buying and eating fewer calories and healthier macronutrient profiles in laboratory tasks and brief field studies. This pilot study examines whether episodic future thinking (EFT) improves mothers' dietary behavior and food purchasing over a longer 7-10-day period. The study utilized a 2 × 2 factorial design with mothers (N = 60) randomized to EFT or standardized episodic thinking (SET) crossed with dietary approaches to stop hypertension (DASH) diet education or a food safety education control. Participants listened to their cues (e.g., recordings of themselves imagining a future event or recalling a past episode) using a mobile ecological momentary intervention (EMI) tool and returned to complete a follow-up dietary recall and submit food receipts. Results showed diets of mothers in the EFT groups became more concordant with the DASH diet (η p 2  = 0.08, p < .05) than mothers in the SET group. When considering food purchases for the family, there was an EFT effect on milligrams of sodium purchased (η p 2  = 0.07, p < .05) and a trend towards a decrease in grams of fat purchased (η p 2  = 0.06, p = .06), however, these findings were no longer significant after correcting for multiple comparisons. There were no DASH education effects and no DASH by EFT interactions observed. The dietary intake and food purchasing results should be replicated in larger more representative samples.",2020,"Results showed diets of mothers in the EFT groups became more concordant with the DASH diet (η p 2  = 0.08, p < .05) than mothers in the SET group.",['2\u202f×\u202f2 factorial design with mothers (N\u202f=\u202f60) randomized to'],"['episodic future thinking (EFT', 'EFT or standardized episodic thinking (SET) crossed with dietary approaches to stop hypertension (DASH) diet education or a food safety education control', 'mobile ecological momentary intervention (EMI) tool and returned to complete a follow-up dietary recall and submit food receipts']","['DASH education effects', ""mothers' dietary behavior and food purchasing"", 'grams of fat purchased']","[{'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C1456535', 'cui_str': 'Food Safety'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",60.0,0.0401892,"Results showed diets of mothers in the EFT groups became more concordant with the DASH diet (η p 2  = 0.08, p < .05) than mothers in the SET group.","[{'ForeName': 'Kelseanna', 'Initials': 'K', 'LastName': 'Hollis-Hansen', 'Affiliation': 'Department of Population Health, University of Texas at Austin, Dell Medical School, Austin, TX, USA; University of Texas at Austin, Steve Hicks School of Social Work, Austin, TX, USA. Electronic address: kelseanna.hollishansen@austin.utexas.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Seidman', 'Affiliation': 'Department of Pediatrics, Division of Behavioral Medicine, University at Buffalo, Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': ""O'Donnell"", 'Affiliation': 'Department of Pediatrics, Division of Behavioral Medicine, University at Buffalo, Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Leonard H', 'Initials': 'LH', 'LastName': 'Epstein', 'Affiliation': 'Department of Pediatrics, Division of Behavioral Medicine, University at Buffalo, Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}]",Appetite,['10.1016/j.appet.2020.104757']
1060,32524934,"Examining child intake frequency, mothers' own liking and child early exposure as potential predictors of child liking for restricted foods and drinks at 5 years old.","OBJECTIVE


To examine longitudinal patterns of child introduction to foods and drinks targeted for restriction by parents and associations between child intake frequency, mother's own liking, child early exposure and child liking for restricted foods and drinks at 5 years old.
DESIGN


The study involved secondary analyses of longitudinal data from mothers and children participating in the NOURISH randomised controlled trial. Patterns of descriptive data were examined, and a binary logistic regression model tested for prediction of child liking of a selection of restricted foods and drinks.
SETTING


Brisbane and Adelaide, Australia.
PARTICIPANTS


Two hundred and eleven mothers and their first born 5-year-old children.
RESULTS


The proportion of children who had tried the selected restricted foods and drinks progressively increased from 14 months to 5 years old. Mothers' own high liking for both sweet and savoury restricted foods and drinks predicted child high liking for the same items at 5 years old. Child high intake frequency at 5 years old also predicted child high liking for sweet foods and drinks, but child early exposure did not predict child liking for the restricted items examined.
CONCLUSIONS


These results challenge the belief that limiting children's intake of foods high in sugar, fat and/or salt will increase their liking for them. Findings instead suggest that restricting children's access to such foods may be beneficial. While further research is required, mothers should be made aware that their own food preferences may inadvertently influence their child's liking for the very foods they are trying to restrict.",2020,Mothers' own high liking for both sweet and savoury restricted foods and drinks predicted child high liking for the same items at 5 years old.,"['Two hundred and eleven mothers and their first born 5-year-old children', 'Brisbane and Adelaide, Australia', 'mothers and children participating in the NOURISH randomised controlled trial']",[],[],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],[],211.0,0.0156282,Mothers' own high liking for both sweet and savoury restricted foods and drinks predicted child high liking for the same items at 5 years old.,"[{'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Jackson', 'Affiliation': 'School of Exercise and Nutrition Sciences, Queensland University of Technology, Brisbane, Queensland4059, Australia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Jansen', 'Affiliation': 'School of Exercise and Nutrition Sciences, Queensland University of Technology, Brisbane, Queensland4059, Australia.'}, {'ForeName': 'Kimberley M', 'Initials': 'KM', 'LastName': 'Mallan', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Brisbane, Queensland, Australia.'}]",Public health nutrition,['10.1017/S1368980020000312']
1061,32524948,Rapid Reduction of  Campylobacter  Species in the Gut Microbiome of Preschool Children after Oral Azithromycin: A Randomized Controlled Trial.,"Campylobacter  has emerged as a potential important cause of childhood morbidity in sub-Saharan Africa. Biannual mass azithromycin distribution has previously been shown to reduce all-cause child mortality in sub-Saharan Africa. We conducted a randomized controlled trial in Burkina Faso in which children were randomized in a 1:1 fashion to a 5-day course of azithromycin or placebo to investigate the effect of oral antibiotics on the gut microbiome. We evaluated the changes in the gut microbiome of preschool children treated with azithromycin using metagenomic DNA sequencing. We found that three  Campylobacter  species were reduced with azithromycin treatment compared with placebo. These results were consistent with other studies that have shown decreases in  Campylobacter  species after azithromycin treatment, generating the hypothesis that a decrease in  Campylobacter  may contribute to observations of reduction in mortality following azithromycin distribution.",2020,We found that three  Campylobacter  species were reduced with azithromycin treatment compared with placebo.,"['Preschool Children after Oral', 'preschool children treated with']","['azithromycin', 'Azithromycin', 'azithromycin or placebo', 'placebo']",[],"[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0812107,We found that three  Campylobacter  species were reduced with azithromycin treatment compared with placebo.,"[{'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Hinterwirth', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sié', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Boubacar', 'Initials': 'B', 'LastName': 'Coulibaly', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Lucienne', 'Initials': 'L', 'LastName': 'Ouermi', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Dah', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Charlemagne', 'Initials': 'C', 'LastName': 'Tapsoba', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Cindi', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Doan', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, California.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0940']
1062,32530412,The Effects of Intensive Versus Routine Treatment in Patients with Acute Kidney Injury.,"BACKGROUND


In patients with acute kidney injury (AKI), specialized treatment-initiated in response to an early-warning system- may be beneficial compared with routine treatment.
METHOD


To explore effect estimators in a pilot trial (DRKS00010530), patients with AKI on regular wards of a university hospital were treated either in the usual way (control group) or more intensively (intervention group). The subjects were allotted randomly to the two treatment groups. The more intensive treatment consisted of an early warning system for a rise in the serum creatinine concentration, immediate consultation of a specialist, and the issuance of a patient kidney passport. The primary endpoint was recovery of renal function after AKI during the index hospitalization. Renal complications and process indicators were the secondary endpoints.
RESULTS


The proportion of patients whose renal function returned to baseline after AKI was 50% in the intervention group (N = 26) and 42% in the control group (N = 26) (odds ratio 1.4, 95% confidence interval [0.5; 4.0], p = 0.58). The calculated glomerular filtration rate went down, from hospital admission to discharge, by 3 mL/min/1.73 m2 (1st-3rd quartile: [6; -20]) in the intervention group and by 13 mL/min/1.73 m2 in the control group (1st-3rd quartile: [0; -25]; p = 0.09). Complications of AKI such as hyperkalemia, pulmonary edema, and renal acidosis were rarer in the intervention group (15% versus 39%; p = 0.03). In the intervention group, compared with the control group, the cause of AKI was identified more frequently (27% versus 4%; p = 0.05); drugs with relevance to the kidney were discontinued more frequently (65% versus 31%; p = 0.01); and the diagnosis of AKI was more frequently documented in the patient's chart (58% versus 37%; p = 0.03).
CONCLUSION


Specialized consultations supported by an early warning system for AKI seem to be beneficial for patients. The findings of this pilot trial should be verified in larger-scale randomized controlled trials.",2020,"The calculated glomerular filtration rate went down, from hospital admission to discharge, by 3 mL/min/1.73 m2 (1st-3rd quartile:","['patients with acute kidney injury (AKI', 'Patients with Acute Kidney Injury', 'patients with AKI on regular wards of a university hospital']",['Intensive Versus Routine Treatment'],"['cause of AKI', 'renal function', 'recovery of renal function', 'calculated glomerular filtration rate', 'diagnosis of AKI', 'Complications of AKI such as hyperkalemia, pulmonary edema, and renal acidosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0034063', 'cui_str': 'Pulmonary edema'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0001122', 'cui_str': 'Acidosis'}]",,0.061064,"The calculated glomerular filtration rate went down, from hospital admission to discharge, by 3 mL/min/1.73 m2 (1st-3rd quartile:","[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Haase-Fielitz', 'Affiliation': 'Department of Cardiology, Brandenburg Heart Center, Immanuel Hospital, Bernau; Brandenburg Medical School Theodor Fontane; Institute of Social Medicine and Health Systems Research, Magdeburg University, Magdeburg; Department of Nephrology and Endocrinology, Ernst von Bergmann Hospital, Potsdam; Department of Urology and Pediatric Urology, Magdeburg University Hospital, Magdeburg; Department of Orthopedics and Trauma Surgery, Ameos Hospital, Schönebeck; Institute of Laboratory Medicine, Leipzig University Hospital, Leipzig; Diaverum Renal Care Center Am Neuen Garten, Potsdam; Faculty of Medicine, Otto-von-Guericke University of Magdeburg; Department of Nephrology, Essen University Hospital, Essen.'}, {'ForeName': 'Saban', 'Initials': 'S', 'LastName': 'Elitok', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schostak', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ernst', 'Affiliation': ''}, {'ForeName': 'Berend', 'Initials': 'B', 'LastName': 'Isermann', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Albert', 'Affiliation': ''}, {'ForeName': 'Bernt-Peter', 'Initials': 'BP', 'LastName': 'Robra', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kribben', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Haase', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2020.0289']
1063,32533792,"Perioperative COX2 and β-adrenergic blockade improves biomarkers of tumor metastasis, immunity, and inflammation in colorectal cancer: A randomized controlled trial.","BACKGROUND


Preclinical studies have implicated excess release of catecholamines and prostaglandins in the mediation of prometastatic processes during surgical treatment of cancer. In this study, we tested the combined perioperative blockade of these pathways in patients with colorectal cancer (CRC).
METHODS


In a randomized, double-blind, placebo-controlled biomarker trial involving 34 patients, the β-blocker propranolol and the COX2-inhibitor etodolac were administered for 20 perioperative days, starting 5 days before surgery. Excised tumors were subjected to whole genome messenger RNA profiling and transcriptional control pathway analyses.
RESULTS


Drugs were well-tolerated, with minor complications in both the treatment group and the placebo group. Treatment resulted in a significant improvement (P < .05) of tumor molecular markers of malignant and metastatic potential, including 1) reduced epithelial-to-mesenchymal transition, 2) reduced tumor infiltrating CD14 +  monocytes and CD19 +  B cells, and 3) increased tumor infiltrating CD56 +  natural killer cells. Transcriptional activity analyses indicated a favorable drug impact on 12 of 19 a priori hypothesized CRC-related transcription factors, including the GATA, STAT, and EGR families as well as the CREB family that mediates the gene regulatory impact of β-adrenergic- and prostaglandin-signaling. Alterations observed in these transcriptional activities were previously associated with improved long-term clinical outcomes. Three-year recurrence rates were assessed for long-term safety analyses. An intent-to-treat analysis revealed that recurrence rates were 12.5% (2/16) in the treatment group and 33.3% (6/18) in the placebo group (P = .239), and in protocol-compliant patients, recurrence rates were 0% (0/11) in the treatment group and 29.4% (5/17) in the placebo group (P = .054).
CONCLUSIONS


The favorable biomarker impacts and clinical outcomes provide a rationale for future randomized placebo-controlled trials in larger samples to assess the effects of perioperative propranolol/etodolac treatment on oncological clinical outcomes.",2020,"Treatment resulted in a significant improvement (P < .05) of tumor molecular markers of malignant and metastatic potential, including 1) reduced epithelial-to-mesenchymal transition, 2) reduced tumor infiltrating CD14 +  monocytes and CD19 +  B cells, and 3) increased tumor infiltrating CD56 +  natural killer cells.","['colorectal cancer', '34 patients, the', 'patients with colorectal cancer (CRC']","['β-blocker propranolol and the COX2-inhibitor etodolac', 'Perioperative COX2 and\xa0β-adrenergic blockade', 'propranolol/etodolac treatment', 'placebo']","['recurrence rates', 'tumor molecular markers of malignant and metastatic potential, including 1) reduced epithelial-to-mesenchymal transition, 2) reduced tumor infiltrating CD14 +  monocytes and CD19 +  B cells, and 3) increased tumor infiltrating CD56 +  natural killer cells', 'tolerated']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C1257954', 'cui_str': 'Cyclooxygenase-2 inhibitor'}, {'cui': 'C0059865', 'cui_str': 'Etodolac'}, {'cui': 'C1565860', 'cui_str': 'PTGS2 protein, human'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1523298', 'cui_str': 'Epithelial-Mesenchymal Transformation'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0108748', 'cui_str': 'Lymphocyte antigen CD19'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0108754', 'cui_str': 'Lymphocyte antigen CD56'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}]",34.0,0.578287,"Treatment resulted in a significant improvement (P < .05) of tumor molecular markers of malignant and metastatic potential, including 1) reduced epithelial-to-mesenchymal transition, 2) reduced tumor infiltrating CD14 +  monocytes and CD19 +  B cells, and 3) increased tumor infiltrating CD56 +  natural killer cells.","[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Haldar', 'Affiliation': 'Sagol School of Neuroscience and School of Psychological Sciences, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Itay', 'Initials': 'I', 'LastName': 'Ricon-Becker', 'Affiliation': 'Sagol School of Neuroscience and School of Psychological Sciences, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Arielle', 'Initials': 'A', 'LastName': 'Radin', 'Affiliation': 'Department of Psychology, UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Mordechai', 'Initials': 'M', 'LastName': 'Gutman', 'Affiliation': 'Department of Surgery and Transplantation, Sheba Medical Center, Ramat-Gan, Israel.'}, {'ForeName': 'Steve W', 'Initials': 'SW', 'LastName': 'Cole', 'Affiliation': 'Departments of Medicine and Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Oded', 'Initials': 'O', 'LastName': 'Zmora', 'Affiliation': ""Department of Surgery, Shamir Medical Center, Be'er-Ya'akov, Israel.""}, {'ForeName': 'Shamgar', 'Initials': 'S', 'LastName': 'Ben-Eliyahu', 'Affiliation': 'Sagol School of Neuroscience and School of Psychological Sciences, Tel-Aviv University, Tel-Aviv, Israel.'}]",Cancer,['10.1002/cncr.32950']
1064,32531968,Influence of Music on Closed Motor Skills: A Controlled Study with Novice Female Dart-Throwers.,"The influence of music heard at different tempos is analyzed during the execution of a dart-throwing task. The sample consisted of 56 female university students (Mean age = 23.38, SD = 6.773). The participants were randomly assigned to GC (group control without music;  n  = 18), GS (group with slow-paced music at a tempo of 60 BPM;  n  = 19) and GF (group with fast-paced music at a tempo of 105 BPM;  n  = 19). All participants performed a dart-throwing task in two phases. Analysis of the scores obtained during Phase 1 and Phase 2 of dart throwing (examining both between-group differences and within-group differences, i.e., changes in scores from Phase 1 to Phase 2 using a mixed factorial ANOVA) revealed no differences in dart-throwing scores. There were, however, differences in execution time, where the participants in GS needed more time to complete the task than those in GF ( F (2 , 55)  = 4.426,  p  = 0.017) with a large effect size ( ŋ 2 p  = 0.143), although neither of these groups differed from GC. The results are discussed in terms of the role of music in precision tasks and the synchronization of the task with the pace of the music .",2020,"There were, however, differences in execution time, where the participants in GS needed more time to complete the task than those in GF ( F (2 , 55)  = 4.426,  p  = 0.017) with a large effect size ( ŋ 2 p  = 0.143), although neither of these groups differed from GC.","['56 female university students (Mean age = 23.38, SD = 6.773', 'Novice Female Dart-Throwers']","['GC', 'Music', 'GS (group with slow-paced music at a tempo of 60 BPM;  n  = 19) and GF (group with fast-paced music']","['Closed Motor Skills', 'execution time']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336707', 'cui_str': 'Dart'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0076082', 'cui_str': 'tempamine'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]","[{'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0510927,"There were, however, differences in execution time, where the participants in GS needed more time to complete the task than those in GF ( F (2 , 55)  = 4.426,  p  = 0.017) with a large effect size ( ŋ 2 p  = 0.143), although neither of these groups differed from GC.","[{'ForeName': 'Félix', 'Initials': 'F', 'LastName': 'Arbinaga', 'Affiliation': 'Department of Clinical and Experimental Psychology, Faculty of Education, Psychology and Sports Science, University of Huelva, 21007 Huelva, Spain.'}, {'ForeName': 'Nehemías', 'Initials': 'N', 'LastName': 'Romero-Pérez', 'Affiliation': 'Department of Social, Evolutionary and Educational Psychology, Faculty of Education, Psychology and Sports Science, University of Huelva, 21007 Huelva, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Torres-Rosado', 'Affiliation': 'Department of Clinical and Experimental Psychology, Faculty of Education, Psychology and Sports Science, University of Huelva, 21007 Huelva, Spain.'}, {'ForeName': 'Eduardo J', 'Initials': 'EJ', 'LastName': 'Fernández-Ozcorta', 'Affiliation': 'Department of Physical Activity and Sports, Center for University Studies Cardenal Spínola CEU, University of Seville Attached Centre, 41930 Sevilla, Spain.'}, {'ForeName': 'María Isabel', 'Initials': 'MI', 'LastName': 'Mendoza-Sierra', 'Affiliation': 'Department of Social, Evolutionary and Educational Psychology, Faculty of Education, Psychology and Sports Science, University of Huelva, 21007 Huelva, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17114146']
1065,32540134,Event-related desynchronization of alpha and beta band neural oscillations predicts speech and limb motor timing deficits in normal aging.,"Normal aging is associated with decline of motor timing mechanisms implicated in planning and execution of movement. Evidence from previous studies has highlighted the relationship between neural oscillatory activities and motor timing processing in neurotypical younger adults; however, it remains unclear how normal aging affects the underlying neural mechanisms of movement in older populations. In the present study, we recorded EEG activities in two groups of younger and older adults while they performed randomized speech and limb motor reaction time tasks cued by temporally predictable and unpredictable sensory stimuli. Our data showed that older adults were significantly slower than their younger counterparts during speech production and limb movement, especially in response to temporally unpredictable sensory stimuli. This behavioral effect was accompanied by significant desynchronization of alpha (7-12 Hz) and beta (13-25 Hz) band neural oscillatory activities in older compared with younger adults, primarily during the preparatory pre-motor phase of responses for speech production and limb movement. In addition, we found that faster motor reaction times in younger adults were significantly correlated with weaker desynchronization of pre-motor alpha and beta band neural activities irrespective of stimulus timing and response modality. However, the pre-motor components of alpha and beta activities were timing-specific in older adults and were more strongly desynchronized in response to temporally predictable sensory stimuli. These findings highlight the role of alpha and beta band neural oscillations in motor timing processing mechanisms and reflect their functional deficits during the planning phase of speech production and limb movement in normal aging.",2020,"Our data showed that older adults were significantly slower than their younger counterparts during speech production and limb movement, especially in response to temporally unpredictable sensory stimuli.","['Normal Aging', 'neurotypical younger adults', 'two groups of younger and older adults', 'older adults']",['randomized speech and limb motor reaction time tasks cued by temporally predictable and unpredictable sensory stimuli'],['faster motor reaction times'],"[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",,0.0320888,"Our data showed that older adults were significantly slower than their younger counterparts during speech production and limb movement, especially in response to temporally unpredictable sensory stimuli.","[{'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Johari', 'Affiliation': 'Speech Neuroscience Lab, Department of Communication Sciences and Disorders, University of South Carolina, Columbia, SC, United States; Department of Psychology, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Roozbeh', 'Initials': 'R', 'LastName': 'Behroozmand', 'Affiliation': 'Speech Neuroscience Lab, Department of Communication Sciences and Disorders, University of South Carolina, Columbia, SC, United States. Electronic address: r-behroozmand@sc.edu.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112763']
1066,32540150,Sleeve gastrectomy and Roux-en-Y gastric bypass in the treatment of type 2 diabetes. Two-year results from a Swedish multicenter randomized controlled trial.,"BACKGROUND


Obesity is a world-wide epidemic and it is a risk factor for type 2 diabetes (T2D). Few randomized controlled studies have compared the 2 most common surgical procedures, Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) in the treatment of obese patients with T2D.
OBJECTIVES


To compare diabetes remission rates (glycosylated hemoglobin ≤6.0%, without diabetes medications) in obese T2D patients (body mass index, 35-50) undergoing RYGB or SG.
SETTING


Three University Hospital clinics and 1 Regional Hospital in Sweden.
METHODS


Forty-nine patients with T2D were included. Twenty-five were randomized to RYGB and 24 to SG. There was no difference between groups regarding patient characteristics, duration of T2D, overall usage of antidiabetic medications, or glycosylated hemoglobin levels. All patients (100%) completed 1-year follow-up and 47 (95.9%) 2-year follow-up.
RESULTS


Remission of T2D was not significantly different between the RYGB and SG, reaching 44% and 46% (n = 25 and n = 24, respectively, P = .897, power = .80) at 1 year, and 48% and 55% (n = 25 and n = 22, respectively, P = .654) at 2 years of follow-up. Similarly, mean glycosylated hemoglobin was improved in both groups at 1 and 2 years, with no significant differences between the groups (RYGB baseline versus 1 yr; mean ± standard deviation: 7.9 ± 1.5 versus 5.8 ± .6%, P < .0001; versus 2 yr: 5.9 ± .7%, P < .0001; SG baseline versus 1 yr: 8.2 ± 1.9 versus 5.9 ± .7%, P < .0001; versus 2 yr: 5.9 ± 1.1%, P < .0001). Total weight loss was not different but percentage excess weight loss was higher after RYGB compared with SG both at 1 and 2 years; mean ± standard deviation: 78 ± 22 versus 60 ± 22%, and 76 ± 24 versus 54 ± 21%, respectively (P < .01 for both). Waist circumference also decreased significantly more in the RYGB group.
CONCLUSIONS


Despite superior excess weight loss after RYGB, T2D remission rates did not differ significantly between RYGB and SG after 2 years. Long-term follow-up data are needed to define the role of SG in the treatment of patients with obesity and T2D.",2020,"RESULTS


Remission of T2D was not significantly different between the RYGB and SG, reaching 44% and 46% (n = 25 and n = 24, respectively, P = .897, power = .80) at 1 year, and 48% and 55% (n = 25 and n = 22, respectively, P = .654) at 2 years of follow-up.","['patients with obesity and T2D', 'obese patients with T2D', 'obese T2D patients (body mass index, 35-50) undergoing RYGB or SG', 'Forty-nine patients with T2D were included', 'Twenty-five were randomized to RYGB and 24 to SG', 'type 2 diabetes', 'Three University Hospital clinics and 1 Regional Hospital in Sweden']","['Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG', 'Sleeve gastrectomy and Roux-en-Y gastric bypass']","['Waist circumference', 'Total weight loss', 'T2D remission rates', 'mean glycosylated hemoglobin', 'patient characteristics, duration of T2D, overall usage of antidiabetic medications, or glycosylated hemoglobin levels', 'Remission of T2D', 'diabetes remission rates', 'weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017853', 'cui_str': 'Glycosylated hemoglobin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",49.0,0.0638498,"RESULTS


Remission of T2D was not significantly different between the RYGB and SG, reaching 44% and 46% (n = 25 and n = 24, respectively, P = .897, power = .80) at 1 year, and 48% and 55% (n = 25 and n = 22, respectively, P = .654) at 2 years of follow-up.","[{'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Wallenius', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital Östra, University of Gothenburg, Gothenburg, Sweden. Electronic address: ville.wallenius@gastro.gu.se.'}, {'ForeName': 'Aiham', 'Initials': 'A', 'LastName': 'Alaraj', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Niclas', 'Initials': 'N', 'LastName': 'Björnfot', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Orrenius', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Kylebäck', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Björklund', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital Östra, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Werling', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Thorell', 'Affiliation': 'Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Stockholm, Sweden; Department of Surgery, Ersta Hospital, Stockholm, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Fändriks', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Almantas', 'Initials': 'A', 'LastName': 'Maleckas', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden; Department of Surgery, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.04.033']
1067,32541620,Cost-Effectiveness and Return-on-Investment of the Dynamic Work Intervention Compared With Usual Practice to Reduce Sedentary Behavior.,"OBJECTIVE


To assess the cost-effectiveness and return-on-investment (ROI) of the Dynamic Work (DW) Intervention, a worksite intervention aimed at reducing sitting time among office workers.
METHODS


In total, 244 workers were randomized to the intervention or control group. Overall sitting time, standing time, step counts, quality-adjusted life years (QALYs), and costs were measured over 12 months. The cost-effectiveness analysis was performed from the societal perspective and the ROI analysis from the employers' perspective.
RESULTS


No significant differences in effects and societal costs were observed between groups. Presenteeism costs were significantly lower in the intervention group. The probability of the intervention being cost-effective was 0.90 at a willingness-to-pay of 20,000&OV0556;/QALY. The probability of financial savings was 0.86.
CONCLUSION


The intervention may be considered cost-effective from the societal perspective depending on the willingness-to-pay. From the employer perspective, the intervention seems cost-beneficial.",2020,Presenteeism costs were significantly lower in the intervention group.,"['office workers', '244 workers']","['Dynamic Work Intervention', 'Dynamic Work (DW) Intervention']","['Presenteeism costs', 'cost-effectiveness and return-on-investment (ROI', 'Overall sitting time, standing time, step counts, quality-adjusted life years (QALYs), and costs', 'Cost-Effectiveness and Return-on-Investment', 'effects and societal costs', 'probability of financial savings']","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C4517660', 'cui_str': '244'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4042785', 'cui_str': 'Sickness Presence'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0021953', 'cui_str': 'Investments'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0036245', 'cui_str': 'Savings'}]",244.0,0.0277514,Presenteeism costs were significantly lower in the intervention group.,"[{'ForeName': 'Ângela J', 'Initials': 'ÂJ', 'LastName': 'Ben', 'Affiliation': 'Department of Health Sciences, Faculty Science, Amsterdam Public Health Research Institute (Dr Ben, Dr van Dongen, Dr Bosmans); and Department of Public and Occupational Health, Amsterdam Public Health Research Institute, Amsterdam UMC (Dr Jelsma, Ms Renaud, Dr Huysmans, Dr van Nassau, Dr van der Beek, Dr van der Ploeg), Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Judith G M', 'Initials': 'JGM', 'LastName': 'Jelsma', 'Affiliation': ''}, {'ForeName': 'Lidewij R', 'Initials': 'LR', 'LastName': 'Renaud', 'Affiliation': ''}, {'ForeName': 'Maaike A', 'Initials': 'MA', 'LastName': 'Huysmans', 'Affiliation': ''}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'van Nassau', 'Affiliation': ''}, {'ForeName': 'Allard J', 'Initials': 'AJ', 'LastName': 'van der Beek', 'Affiliation': ''}, {'ForeName': 'Hidde P', 'Initials': 'HP', 'LastName': 'van der Ploeg', 'Affiliation': ''}, {'ForeName': 'Johanna M', 'Initials': 'JM', 'LastName': 'van Dongen', 'Affiliation': ''}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001930']
1068,32543021,Effect of short-acting exenatide administered three times daily on markers of cardiovascular disease in type 1 diabetes: A randomized double-blind placebo-controlled trial.,"AIMS


To investigate the effect of adding the short-acting glucagon-like peptide 1 receptor agonist (GLP-1RA) exenatide to insulin treatment on markers of cardiovascular risk in type 1 diabetes.
MATERIALS AND METHODS


In a randomized, double-blind, parallel-group trial, 108 individuals with type 1 diabetes aged ≥18 years on multiple daily injection therapy with a body mass index >22.0 kg/m 2  and glycated haemoglobin concentration of 59 to 88 mmol/mol (7.5%-10.0%) were randomized (1:1) to preprandial subcutaneous injection of 10 μg exenatide (Byetta®) or placebo three times daily over 26 weeks as add-on treatment to existing insulin therapy. Reported markers of cardiovascular risk were secondary endpoints and were analyzed in a baseline-adjusted linear mixed model in the intention-to-treat population. The primary results of this study, the MAG1C (Meal-time Administration of exenatide for Glycaemic control in type 1 diabetes Cases) trial, were previously reported.
RESULTS


Exenatide changed total fat mass by -2.6 kg (95% confidence interval [CI] -3.6; -1.6; P < 0.0001) and lean body mass by -1.1 kg (95% CI -1.9; -0.4; P = 0.01) compared with placebo, as assessed by dual-energy X-ray absorptiometry. Fat mass reductions were similar for central and peripheral fat mass. Exenatide did not change levels of interleukin-2 or -6; tumour necrosis factor-α; C-reactive protein; N-terminal prohormone of brain natriuretic peptide; or 8-oxo-7,8-dihydroguanosine (RNA oxidation marker) and 8-oxo-7,8-dihydro-2'-deoxyguanosine (DNA oxidation marker).
CONCLUSIONS


Exenatide added to insulin therapy in type 1 diabetes for 26 weeks resulted in body weight loss primarily from fat mass reduction, but had no effect on biomarkers of cardiovascular disease risk.",2020,Exenatide did not change levels of interleukin-2 or -6; tumour necrosis factor-α,"['type 1 diabetes', '108 individuals with type 1 diabetes aged ≥18\u2009years on multiple daily injection therapy with a body mass index >22.0\u2009kg/m 2  and glycated haemoglobin concentration of 59 to 88\u2009mmol/mol (7.5%-10.0']","['exenatide', 'Exenatide', 'short-acting exenatide', ""8-oxo-7,8-dihydroguanosine (RNA oxidation marker) and 8-oxo-7,8-dihydro-2'-deoxyguanosine (DNA oxidation marker"", 'short-acting glucagon-like peptide 1 receptor agonist (GLP-1RA) exenatide to insulin treatment', 'preprandial subcutaneous injection of 10 μg exenatide (Byetta®) or placebo three times daily over 26\u2009weeks as add-on treatment to existing insulin therapy', 'placebo']","['cardiovascular risk', 'body weight loss', 'change levels of interleukin-2 or -6; tumour necrosis factor-α', 'lean body mass', 'cardiovascular disease', 'total fat mass', 'Fat mass reductions']","[{'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C4517859', 'cui_str': '7.5'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0050092', 'cui_str': '8-hydroxyguanosine'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0050078', 'cui_str': '8-hydroxy-deoxyguanosine'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1550738', 'cui_str': 'Before food'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C1636686', 'cui_str': 'Byetta'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",108.0,0.741312,Exenatide did not change levels of interleukin-2 or -6; tumour necrosis factor-α,"[{'ForeName': 'Nicklas J', 'Initials': 'NJ', 'LastName': 'Johansen', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Dejgaard', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Asger', 'Initials': 'A', 'LastName': 'Lund', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Schlüntz', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Emil L', 'Initials': 'EL', 'LastName': 'Larsen', 'Affiliation': 'Department of Clinical Pharmacology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henrik E', 'Initials': 'HE', 'LastName': 'Poulsen', 'Affiliation': 'Department of Clinical Pharmacology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens P', 'Initials': 'JP', 'LastName': 'Goetze', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Holger J', 'Initials': 'HJ', 'LastName': 'Møller', 'Affiliation': 'Department of Clinical Biochemistry, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Henrik U', 'Initials': 'HU', 'LastName': 'Andersen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14078']
1069,32543122,Study within a trial protocol: Same-day consent vs. delayed consent in a randomized trial.,"BACKGROUND


Randomized trials are designed to evaluate the effects of health care interventions. The recruitment process in a randomized trial can be challenging. Poor recruitment can have a negative impact on the allocated budget and estimated completion date of the study and may result in an underpowered research that will not adequately answer the original research question.
AIM


We aim to perform a Study Within A Trial (SWAT) to evaluate the impact of same-day consent or delayed consent on recruitment and retention in the host trial.
METHODS


This SWAT is designed as an observational study. However, the host trial is a randomized controlled trial evaluating the effectiveness of an intensive lifestyle modification program in patients with peripheral arterial disease. For this trial and SWAT, same-day consent is defined as the patient giving consent on the same day, after the investigator has fully explained the predesigned information leaflet for the host trial. Delayed consent is defined as the patient feeling they still need further time to consider their decision to participate or not.
SWAT REGISTRATION


The SWAT was registered on the Northern Ireland Network for Trials Methodology Research.",2020,"However, the host trial is a randomized controlled trial evaluating the effectiveness of an intensive lifestyle modification program in patients with peripheral arterial disease.",['patients with peripheral arterial disease'],['intensive lifestyle modification program'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.1771,"However, the host trial is a randomized controlled trial evaluating the effectiveness of an intensive lifestyle modification program in patients with peripheral arterial disease.","[{'ForeName': 'Marah', 'Initials': 'M', 'LastName': 'Elfghi', 'Affiliation': 'School of Medicine, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Fionnuala', 'Initials': 'F', 'LastName': 'Jordan', 'Affiliation': 'School of Medicine, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Sherif', 'Initials': 'S', 'LastName': 'Sultan', 'Affiliation': 'Department of Vascular and Endovascular Surgery, University College Hospital, Galway, Ireland.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Tawfick', 'Affiliation': 'School of Medicine, National University of Ireland, Galway, Ireland.'}]",Journal of evidence-based medicine,['10.1111/jebm.12392']
1070,32518854,"Fecal microbiota transplantation for patients on antibiotic treatment with  C. difficile  infection history (GRAFT): Study protocol for a phase II, randomized, double-blind, placebo-controlled trial to prevent recurrent  C. difficile  infections.","Recurrent  Clostridiodes difficile  infections (rCDIs) are a burdensome problem. Patients with a history of CDI that are prescribed antibiotics are at a high risk for recurrence. Fecal microbiota transplantation (FMT) has been shown to be an effective treatment for rCDI, though there is little information on the impact of FMT with antibiotics on the gut microbiome. We are conducting a clinical trial of FMT to prevent rCDI in patients with a history of CDI currently taking antibiotics. Our primary objective is to determine the effect of FMT on the gut microbiome during antibiotic exposure. Our secondary aim is to assess safety and feasibility of using FMT as a prophylaxis for CDI. We plan to enroll 30 patients into a phase II randomized, double-blind, placebo-controlled trial with three arms: (1) 5 FMT capsules per day during antibiotic treatment and for 7 days post antibiotic cessation, (2) a one-time dose of 30 FMT capsules 48-72 h post cessation of antibiotic treatment, or (3) 5 placebo capsules per day during antibiotic treatment and for 7 days post antibiotic treatment. Patients provide stool samples throughout the duration of the study and are cultured  C. difficile.  Sequencing of the V4 region of the 16S rRNA gene will be carried out to assess the gut microbiota. Results of this study will provide information on the impact of FMT on the gut microbiome as well as the necessary data to examine whether or not prophylactic FMT should be explored further as a way to prevent CDI recurrence.",2020,We are conducting a clinical trial of FMT to prevent rCDI in patients with a history of CDI currently taking antibiotics.,"['patients with a history of CDI currently taking antibiotics', 'patients on antibiotic treatment with  C. difficile  infection history (GRAFT', 'recurrent  C. difficile  infections']","['FMT capsules per day during antibiotic treatment and for 7 days post antibiotic cessation, (2) a one-time dose of 30 FMT capsules 48-72\xa0h post cessation of antibiotic treatment, or (3) 5 placebo', 'FMT', 'Fecal microbiota transplantation (FMT', 'placebo']",['Fecal microbiota transplantation'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0282601', 'cui_str': 'Compact Disk Interactive'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}]",,0.33438,We are conducting a clinical trial of FMT to prevent rCDI in patients with a history of CDI currently taking antibiotics.,"[{'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Kates', 'Affiliation': 'Division of Infectious Disease, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Ilsa', 'Initials': 'I', 'LastName': 'Gaulke', 'Affiliation': 'Division of Infectious Disease, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'De Wolfe', 'Affiliation': 'Division of Infectious Disease, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Zimbric', 'Affiliation': 'Division of Infectious Disease, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Haight', 'Affiliation': 'Division of Infectious Disease, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Watson', 'Affiliation': 'Division of Infectious Disease, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Garret', 'Initials': 'G', 'LastName': 'Suen', 'Affiliation': 'Department of Bacteriology, College of Agricultural and Life Sciences, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Kyungmann', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Biostatistics & Medical Informatics, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Nasia', 'Initials': 'N', 'LastName': 'Safdar', 'Affiliation': 'Division of Infectious Disease, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100576']
1071,32521745,"Effects of 6 Weeks of Traditional Resistance Training or High Intensity Interval Resistance Training on Body Composition, Aerobic Power and Strength in Healthy Young Subjects: A Randomized Parallel Trial.","Consistent practice of physical activity has well known positive effects on general health; however, time for exercise remains one major barrier for many. An acute bout of high intensity interval resistance training (HIIRT) increases acute resting energy expenditure (REE) and decreases respiratory ratio (RR), suggesting its potential role on weight loss and increased fatty acid oxidation. The aim of this study was to test the long-term effect of HIIRT on body composition, lipid profile and muscle strength using a randomized parallel trial. Twenty healthy young adults (22.15 1.95 years) were randomized to perform either a HIIRT ( N  = 11) protocol, consisting of three sets of 6 repetitions at 6 repetition maximum (RM) and then 20 seconds of rest between repetitions until exhaustion repeated for 3 times with 2'30″ rest between sets or a traditional training (TRT, N = 9) protocol of 3 sets of 15 reps with 75 sec of rest between sets. Body composition, resting energy metabolism, aerobic capacity, muscle strength and blood measurements were taken before and after 8 weeks of training. Both protocols enhanced muscle strength, but only HIIRT improved endurance strength performance (+22.07%,  p  < 0.05) and lean body mass (+2.82%,  p  < 0.05). REE and RR were unaltered as lipid profile. HIIRT represents a valid training method to improve muscle strength and mass, but its role on body weight control was not confirmed.",2020,"Both protocols enhanced muscle strength, but only HIIRT improved endurance strength performance (+22.07%,  p  < 0.05) and lean body mass (+2.82%,  p  < 0.05).","['Twenty healthy young adults (22.15 1.95 years', 'Healthy Young Subjects']","['high intensity interval resistance training (HIIRT', 'HIIRT', 'Traditional Resistance Training or High Intensity Interval Resistance Training']","['Body Composition, Aerobic Power and Strength', 'Body composition, resting energy metabolism, aerobic capacity, muscle strength and blood measurements', 'endurance strength performance', 'lean body mass', 'weight loss and increased fatty acid oxidation', 'body composition, lipid profile and muscle strength', 'muscle strength', 'REE and RR']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0429743', 'cui_str': 'Respiratory ratio'}]",20.0,0.041387,"Both protocols enhanced muscle strength, but only HIIRT improved endurance strength performance (+22.07%,  p  < 0.05) and lean body mass (+2.82%,  p  < 0.05).","[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Moro', 'Affiliation': 'Department of Biomedical Sciences, University of Padova, 35122 Padova, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Marcolin', 'Affiliation': 'Department of Biomedical Sciences, University of Padova, 35122 Padova, Italy.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Bianco', 'Affiliation': 'Department of Psychology, Educational Science and Human Movement, University of Palermo, 90133 Palermo, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bolzetta', 'Affiliation': 'Department of Medicine, University of Padova, 35122 Padova, Italy.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Berton', 'Affiliation': 'Department of Medicine, University of Padova, 35122 Padova, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Sergi', 'Affiliation': 'Department of Medicine, University of Padova, 35122 Padova, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Paoli', 'Affiliation': 'Department of Biomedical Sciences, University of Padova, 35122 Padova, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17114093']
1072,32521782,"Effect of Morning vs. Evening Turmeric Consumption on Urine Oxidative Stress Biomarkers in Obese, Middle-Aged Adults: A Feasibility Study.","The circadian rhythm of biological systems is an important consideration in developing health interventions. The immune and oxidative defense systems exhibit circadian periodicity, with an anticipatory increase in activity coincident with the onset of the active period. Spice consumption is associated with enhanced oxidative defense. The objective of this study was to test the feasibility of a protocol, comparing the effects of morning vs. evening consumption of turmeric on urine markers of oxidative stress in obese, middle-aged adults. Using a within-sample design, participants received each of four clock time x treatment administrations, each separated by one week: morning turmeric; evening turmeric; morning control; evening control. Participants prepared for each lab visit by consuming a low-antioxidant diet for two days and fasting for 12 h. Urine was collected in the lab at baseline and one-hour post-meal and at home for the following five hours. The results showed that the processes were successful in executing the protocol and collecting the measurements and that participants understood and adhered to the instructions. The findings also revealed that the spice treatment did not elicit the expected antioxidant effect and that the six-hour post-treatment urine collection period did not detect differences in urine endpoints across treatments. This feasibility study revealed that modifications to the spice treatment and urine sampling timeline are needed before implementing a larger study.",2020,The results showed that the processes were successful in executing the protocol and collecting the measurements and that participants understood and adhered to the instructions.,"['obese, middle-aged adults', 'Obese, Middle-Aged Adults']","['morning vs. evening consumption of turmeric', 'Morning vs. Evening Turmeric Consumption']","['Urine Oxidative Stress Biomarkers', 'antioxidant effect']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0041356', 'cui_str': 'Turmeric'}]","[{'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3179302', 'cui_str': 'Antioxidant Effects'}]",,0.0773991,The results showed that the processes were successful in executing the protocol and collecting the measurements and that participants understood and adhered to the instructions.,"[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Blanton', 'Affiliation': 'Department of Nutrition and Dietetics, Idaho State University, Pocatello, ID 83209, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Gordon', 'Affiliation': 'Department of Nutrition and Dietetics, Idaho State University, Pocatello, ID 83209, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17114088']
1073,32521785,An Exploration of the Effectiveness of a Peer-Led Pain Management Program (PAP) for Nursing Home Residents with Chronic Pain and an Evaluation of Their Experiences: A Pilot Randomized Controlled Trial.,"Background:  80% of nursing home residents have reported chronic pain, which is often accepted by older adults as part of aging. Peer support models are being used to help individuals manage their chronic conditions and overcome the challenges of limited healthcare resources. The aims of this study were: (i) to examine the effectiveness of a 12 week peer-led pain management program (PAP) for nursing home residents and (ii) to evaluate their experiences.  Methods:  A cluster randomized controlled trial (RCT) was used. The 12 week pain management program was provided for the experimental group. Outcomes were measured at three time points. The participants' satisfaction and acceptance were evaluated by a semi-structured interview after the program was completed.  Results:  Pain self-efficacy, pain intensity, pain interference, pain knowledge, and depression levels improved after the completion of the 12 week peer-led PAP. The pain-intensity level reported at week 12 was significantly lower in the experimental group than in the control group. Semi-structured interviews showed that the nursing home residents were satisfied with the pain education that they received.  Conclusions:  The 12 week peer-led PAP appeared to improve the pain-related and psychological outcome measures in nursing home residents, and the feedback on the peer-led PAP from the nursing home residents was positive.",2020,"The 12 week peer-led PAP appeared to improve the pain-related and psychological outcome measures in nursing home residents, and the feedback on the peer-led PAP from the nursing home residents was positive.",['Nursing Home Residents with Chronic Pain and an Evaluation of Their Experiences'],"['12 week peer-led pain management program (PAP', 'Peer-Led Pain Management Program (PAP']","['pain-related and psychological outcome measures', 'pain-intensity level', 'chronic pain', 'Pain self-efficacy, pain intensity, pain interference, pain knowledge, and depression levels']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}]",,0.0648035,"The 12 week peer-led PAP appeared to improve the pain-related and psychological outcome measures in nursing home residents, and the feedback on the peer-led PAP from the nursing home residents was positive.","[{'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Tse', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong, China.'}, {'ForeName': 'Yajie', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong, China.'}, {'ForeName': 'Shuk Kwan', 'Initials': 'SK', 'LastName': 'Tang', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong, China.'}, {'ForeName': 'Shamay S M', 'Initials': 'SSM', 'LastName': 'Ng', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Bai', 'Affiliation': 'Department of Applied Social Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong, China.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong, China.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Lo', 'Affiliation': 'Department of Geriatrics and Palliative Medicine, Shatin Hospital, Hospital Authority, Kowloon, Hong Kong, China.'}, {'ForeName': 'Suey Shuk Yu', 'Initials': 'SSY', 'LastName': 'Yeung', 'Affiliation': 'Department of Human Movement Sciences, Vrije Universiteit Amsterdam, 1081 HV Amsterdam, The Netherlands.'}]",International journal of environmental research and public health,['10.3390/ijerph17114090']
1074,32682938,Comparison of Corticosteroid Injection Dosages in Mild to Moderate Idiopathic Carpal Tunnel Syndrome: A Randomized Controlled Trial.,"OBJECTIVES


To evaluate whether the therapeutic effect of ultrasound-guided injections with 10 mg or 40 mg triamcinolone acetonide (TA) was dose-dependent in patients with idiopathic mild to moderate carpal tunnel syndrome (CTS).
DESIGN


Prospective, double-blind, randomized controlled study with 12 weeks of follow-up.
SETTING


Rehabilitation outpatient clinic of a single medical center.
PARTICIPANTS


Patients with CTS (N=56).
INTERVENTION


Participants were randomly assigned to 2 treatment groups for injection: (A) 40 mg TA+2% lidocaine hydrochloride or (B) 10 mg TA+2% lidocaine hydrochloride.
MAIN OUTCOME MEASURES


Participants were evaluated using visual analog scale (VAS) and Boston Carpal Tunnel Questionnaire (BCTQ, including Symptom Severity Scale [SSS] and Functional Status Scale [FSS]) at baseline and 6 and 12 weeks after injection). Nerve conduction studies, including parameters of distal motor latency, amplitude of compound motor action potential, amplitude of sensory nerve action potential and sensory nerve conduction velocity of median nerve, and the patient's subjective impression of improvement, were recorded before injection and 6 and 12 weeks after injection.
RESULTS


No significant differences were observed in baseline demographic characteristics and clinical evaluations. The parameters in group A and B at baseline, 6 weeks, and 12 weeks were (1) SSS: 2.17±0.14, 1.19±0.04, and 1.34±0.09 and 1.87±0.11, 1.21±0.07, and 1.26±0.04; (2) FSS: 1.63±0.07, 1.27±0.06, and 1.33±0.08 and 1.50±0.10, 1.18±0.05, and 1.26±0.05; (3) VAS: 6.4±0.3, 2.2±0.3, and 3.0±0.1 and 6.7±0.3, 2.0±0.3, and 3.1±0.3, respectively, and significantly decreased after 6 and 12 weeks in both treatment groups (P<.05). All parameters of nerve conduction studies improved in both groups after 12 weeks (P<.05). VAS, BCTQ, and nerve conduction studies did not show significant intergroup differences after 6 and 12 weeks.
CONCLUSION


In patients with idiopathic mild to moderate CTS, ultrasound-guided injection with 10 and 40 mg TA yield similar improvements in BCTQ, VAS, and nerve conduction studies at the 12-week follow-up.",2020,All parameters of NCS improved in both groups after 12 weeks (p<0.05).,"['patients with idiopathic mild to moderate CTS', 'Patients with CTS (N=56', 'Rehabilitation outpatient clinic of a single medical center', 'patients with idiopathic mild to moderate carpal tunnel syndrome (CTS', 'mild to moderate idiopathic carpal tunnel syndrome']","['corticosteroid injection dosages', 'injection: (A) 40 mg TA + 2% lidocaine hydrochloride or (B) 10 mg TA + 2% lidocaine hydrochloride', 'ultrasound-guided injections with 10 mg or 40 mg triamcinolone acetonide (TA']","['Visual Analogue Scale (VAS) and Boston Carpal Tunnel Questionnaire (BCTQ, including Symptom Severity Scale (SSS) and Functional Status Scale (FSS', ""parameters of distal motor latency, amplitude of compound motor action potential, amplitude of sensory nerve action potential and sensory nerve conduction velocity of median nerve, and the patient's subjective impression of improvement"", 'baseline demographic characteristics and clinical evaluations', 'NCS', 'BCTQ, VAS, and NCS', 'VAS, BCTQ, and NCS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0546869', 'cui_str': 'Lidocaine hydrochloride'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0265224', 'cui_str': 'Freeman-Sheldon syndrome'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0001272', 'cui_str': 'Action Potentials'}, {'cui': 'C0522219', 'cui_str': 'Sensory potential'}, {'cui': 'C0457378', 'cui_str': 'Sensory nerve conduction velocity'}, {'cui': 'C0025058', 'cui_str': 'Structure of median nerve'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}]",,0.0597336,All parameters of NCS improved in both groups after 12 weeks (p<0.05).,"[{'ForeName': 'Po-Cheng', 'Initials': 'PC', 'LastName': 'Hsu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Bei-Hu Branch, Taipei, Taiwan; Institute of Clinical Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Kwong-Kum', 'Initials': 'KK', 'LastName': 'Liao', 'Affiliation': 'Department of Neurology, Taipei Veterans General Hospital, Taipei, Taiwan; Department of Neurology, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Kon-Ping', 'Initials': 'KP', 'LastName': 'Lin', 'Affiliation': 'Department of Neurology, Taipei Veterans General Hospital, Taipei, Taiwan; Department of Neurology, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Jan-Wei', 'Initials': 'JW', 'LastName': 'Chiu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Pin-Yi', 'Initials': 'PY', 'LastName': 'Wu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chen-Liang', 'Initials': 'CL', 'LastName': 'Chou', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, Taiwan; Department of Physical Medicine and Rehabilitation, School of Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Nin-Yi', 'Initials': 'NY', 'LastName': 'Wang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Jia-Chi', 'Initials': 'JC', 'LastName': 'Wang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, Taiwan; Department of Physical Medicine and Rehabilitation, School of Medicine, National Yang Ming University, Taipei, Taiwan. Electronic address: jcwang0726@gmail.com.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.06.018']
1075,32525863,"Energy-dense vs routine enteral nutrition in New Zealand Europeans, Māori, and Pacific Peoples who are critically ill.","AIMS


To evaluate the effect of energy-dense vs routine enteral nutrition on day-90 mortality by ethnic group in critically ill adults.
METHODS


Pre-planned subgroup analysis of the 1,257 New Zealanders in a 4,000-participant randomised trial comparing energy-dense enteral nutrition (1.5kcal/mL) with routine enteral nutrition (1kcal/mL) in mechanically ventilated intensive care unit (ICU) patients. The primary purpose of this analysis was to evaluate responses to study treatment by ethnic group (European, Māori, and Pacific Peoples) using ethnicity data recorded in the clinical records. The secondary purpose was to compare the characteristics and outcomes of patients by ethnic group. The primary outcome was day-90 mortality.
RESULTS


Among 1,138 patients included in the primary outcome analysis, 165 of 569 (29.0%) assigned to energy-dense nutrition and 156 of 569 patients (27.4%) assigned to routine nutrition died by day 90 (odds ratio; 1.06; 95% CI, 0.92-1.22). There was no statistically significant interaction between treatment allocation and ethnicity with respect to day-90 mortality. Day-90 mortality rates did not vary statistically significantly by ethnic group.
CONCLUSIONS


Among mechanically ventilated adults in New Zealand ICUs, the effect on day-90 mortality of energy-dense vs routine enteral nutrition did not vary by ethnicity.",2020,"Day-90 mortality rates did not vary statistically significantly by ethnic group.
","['mechanically ventilated intensive care unit (ICU) patients', 'critically ill adults', '1,138 patients', 'mechanically ventilated adults in New Zealand ICUs', 'patients by ethnic group']","['Energy-dense vs routine enteral nutrition', 'energy-dense enteral nutrition (1.5kcal/mL) with routine enteral nutrition (1kcal/mL', 'energy-dense vs routine enteral nutrition']","['Day-90 mortality rates', 'day-90 mortality']","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}]","[{'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.201762,"Day-90 mortality rates did not vary statistically significantly by ethnic group.
","[{'ForeName': 'Alice L', 'Initials': 'AL', 'LastName': 'Reid', 'Affiliation': 'Research Fellow, Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Marianne J', 'Initials': 'MJ', 'LastName': 'Chapman', 'Affiliation': 'Research Director, Intensive Care Unit, Royal Adelaide Hospital, Adelaide, SA, Australia; Professor, Faculty of Health and Medical Sciences, The University of Adelaide, SA, Australia; Adjunct Associate Professor, School of Epidemiology and Preventive Medicine, Monash University, VIC, Australia.'}, {'ForeName': 'Sandra L', 'Initials': 'SL', 'LastName': 'Peake', 'Affiliation': 'Director, Department of Intensive Care Medicine, The Queen Elizabeth Hospital, Woodville South, SA, Australia; Professor, Faculty of Health and Medical Sciences, University of Adelaide, SA, Australia; Adjunct Associate Professor, School of Epidemiology and Preventive Medicine, Monash University, VIC, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Intensive Care Specialist, Intensive Care Unit, Austin Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Davies', 'Affiliation': 'Intensive Care Specialist, Intensive Care Unit, Frankston, VIC, Australia.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Deane', 'Affiliation': 'Principal Research Fellow, The University of Melbourne, Melbourne Medical School, Department of Medicine and Radiology, Royal Melbourne Hospital, Parkville, VIC, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Professor of Medicine & Head Endocrine Unit, Adelaide Medical School, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hurford', 'Affiliation': 'ICU Trials Project Manager, Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Biostatistician, Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, SA, Australia.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Little', 'Affiliation': 'Project Manager, School of Epidemiology and Preventive Medicine, Monash University, VIC, Australia.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Mackle', 'Affiliation': 'ICU Programme Manager, Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Stephanie N', 'Initials': 'SN', 'LastName': ""O'Connor"", 'Affiliation': 'ICU Clinical Research Manager, Royal Adelaide Hospital, Adelaide, SA, Australia; Affiliate Senior Lecturer, Acute Care Medicine, The University of Adelaide, SA, Australia.'}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Ridley', 'Affiliation': 'Senior Research Fellow, Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Patricia J', 'Initials': 'PJ', 'LastName': 'Williams', 'Affiliation': 'Research Coordinator, Department of Intensive Care Medicine, The Queen Elizabeth Hospital, Woodville South, SA, Australia; Affiliate Lecturer, Acute Care Medicine, The University of Adelaide, SA, Australia; Adjunct Research Fellow, Department of Epidemiology and Preventative Medicine, Monash University, VIC, Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Young', 'Affiliation': 'Deputy Director, Medical Research Institute of New Zealand, Wellington; Intensive Care Specialist, Wellington Hospital, Wellington.'}]",The New Zealand medical journal,[]
1076,32533622,Blood pressure after follow-up in a stroke prevention clinic.,"OBJECTIVES


In Denmark, 25% of hospital admissions with stroke are recurrent strokes. With thrombolytic treatment, more patients survive with only minor disability. This promising development should be followed up by intensive secondary prevention. Hypertension is the most important target. We aimed at testing the hypotheses that early follow-up in a preventive clinic would result in (a) a higher proportion of patients with blood pressure at target and (b) time to stroke recurrence, myocardial infarction, and death would be longer in the intervention group compared to controls.
MATERIALS AND METHODS


Eligible patients admitted to the stroke unit of Herlev Hospital were randomized shortly before discharge to intervention or control group. Of 78 included participants, data from 73 were available for follow-up 9 months after inclusion. Patients in the intervention group were seen in the clinic within 1 week. In case of hypertension, treatment was initiated or supplied with a new drug. We used individual targets for blood pressure according to diagnosis of stroke and patients' comorbidity. Patients in the intervention group had a median of five visits to the preventive clinic.
RESULTS


In the intervention group, blood pressure was treated to target in 25 patients (69%) versus 14 (38%) in the control group (p = .007). Median time to first event was 44 months (4-49) in the intervention group and 19 months (4-37) in controls (p = .316).
CONCLUSIONS


Treatment of hypertension to individual targets after stroke is feasible. It may postpone recurrent stroke and death in stroke survivors.",2020,"In the intervention group, blood pressure was treated to target in 25 patients (69%) versus 14 (38%) in the control group (p = .007).","['Of 78 included participants, data from 73 were available for follow-up 9\xa0months after inclusion', 'In Denmark, 25% of hospital admissions with stroke are recurrent strokes', 'Eligible patients admitted to the stroke unit of Herlev Hospital']",[],"['blood pressure', 'median of five visits to the preventive clinic', 'Median time to first event', 'blood pressure at target and (b) time to stroke recurrence, myocardial infarction, and death', 'Blood pressure']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0587502', 'cui_str': 'Stroke unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],"[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",78.0,0.0464616,"In the intervention group, blood pressure was treated to target in 25 patients (69%) versus 14 (38%) in the control group (p = .007).","[{'ForeName': 'Agnete Hviid', 'Initials': 'AH', 'LastName': 'Hornnes', 'Affiliation': 'Department of Neurology, Herlev og Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'Mai Bang', 'Initials': 'MB', 'LastName': 'Poulsen', 'Affiliation': 'Department of Neurology, Rigshospitalet, Copenhagen, Denmark.'}]",Brain and behavior,['10.1002/brb3.1667']
1077,32533644,Effects of oxiracetam combined with ginkgo biloba extract in the treatment of acute intracerebral hemorrhage: A clinical study.,"PURPOSE


The present clinical study was conducted to investigate the effect of oxiracetam combined with ginkgo biloba extract in treating patients with acute intracerebral hemorrhage.
METHODS


Ninety-eight patients with acute cerebral hemorrhage admitted to our hospital were divided into three groups. The differences of brain edema and cerebral hemorrhage were compared between the three groups after 1 and 2 weeks of treatment, and the recovery of neurological function, serum inflammatory factors, AQP-4, MMP-9, cognitive function, activities of daily living, and adverse reactions were compared between the three groups after 2 weeks of treatment.
RESULTS


There was no significant difference among the three groups before treatment (p > .05). After treatment, the recovery of neurological function, serum inflammatory factors, AQP-4, MMP-9 levels, cognitive function, and activities of daily living were improved. Among them, the neurological function recovery, serum inflammatory factors, AQP-4, MMP-9 levels, cognitive function, and activities of daily living in the combined treatment group and the control group elicited greater results than those in the routine group. The results of the combined treatment group showed the most significant difference (p < .05). The concentration of IL-6 decreased from 135.98 ± 12.54 to 91.83 ± 7.69 pg/ml, AQP-4 from 227.55 μg/L ± 21.06 to 114.31 ± 9.22 μg/L, and MMP-9 from 172.39 ± 9.81 to 94.98 ± 5.01 ng/ml. In addition, the neurological function recovery, the levels of serum inflammatory factors, cognitive function, and activities of daily living in the combined treatment group were better than those in the control group (p < .05). The mean score of MRS in the combined treatment group decreased from 3.36 ± 0.98 at admission to 1.91 ± 0.38.
CONCLUSION


Oxiracetam combined with Ginkgo biloba extract in the treatment of acute cerebral hemorrhage has a significant improvement effect.",2020,"After treatment, the recovery of neurological function, serum inflammatory factors, AQP-4, MMP-9 levels, cognitive function, and activities of daily living were improved.","['acute intracerebral hemorrhage', 'patients with acute intracerebral hemorrhage', 'Ninety-eight patients with acute cerebral hemorrhage admitted to our hospital']","['Ginkgo biloba extract', 'oxiracetam combined with ginkgo biloba extract']","['neurological function recovery, serum inflammatory factors, AQP-4, MMP-9 levels, cognitive function, and activities of daily living', 'neurological function recovery, the levels of serum inflammatory factors, cognitive function, and activities of daily living', 'acute cerebral hemorrhage', 'brain edema and cerebral hemorrhage', 'recovery of neurological function, serum inflammatory factors, AQP-4, MMP-9 levels, cognitive function, and activities of daily living', 'concentration of IL-6', 'mean score of MRS', 'recovery of neurological function, serum inflammatory factors, AQP-4, MMP-9, cognitive function, activities of daily living, and adverse reactions']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0772125', 'cui_str': 'Ginkgo biloba extract'}, {'cui': 'C0069772', 'cui_str': 'oxiracetam'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0006114', 'cui_str': 'Cerebral edema'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",98.0,0.0301242,"After treatment, the recovery of neurological function, serum inflammatory factors, AQP-4, MMP-9 levels, cognitive function, and activities of daily living were improved.","[{'ForeName': 'Xiu-Xiu', 'Initials': 'XX', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Linyi Central Hospital, Linyi, China.'}, {'ForeName': 'Shi-Hui', 'Initials': 'SH', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Linyi Central Hospital, Linyi, China.'}, {'ForeName': 'Su-Jing', 'Initials': 'SJ', 'LastName': 'Zhuang', 'Affiliation': 'Department of Neurology, Linyi Central Hospital, Linyi, China.'}, {'ForeName': 'Shi-Feng', 'Initials': 'SF', 'LastName': 'Guo', 'Affiliation': 'Department of Neurology, Linyi Central Hospital, Linyi, China.'}, {'ForeName': 'Shou-Liang', 'Initials': 'SL', 'LastName': 'Pang', 'Affiliation': 'Department of Neurology, Linyi Central Hospital, Linyi, China.'}]",Brain and behavior,['10.1002/brb3.1661']
1078,32531956,Effect of a Six-Week Intermittent Fasting Intervention Program on the Composition of the Human Body in Women over 60 Years of Age.,"The objective of this research was to determine the effectiveness of intermittent fasting (IF) in reducing body fat and lowering body mass index. An additional objective was to determine the feasibility of applying IF in overweight women over 60 years of age, which was assessed by the ratio of subjects who resigned from the diet plan. This study included a group of 45 women over 60 years of age. The intervention in the experimental group involved complete abstinence from food intake for 16 h per day, from 20:00 p.m. to 12:00 a.m. (the next day). The results demonstrated that the body weight in the subjects in the experimental group (EXP) group decreased by almost 2 kg and this decrease was visible in the remaining parameters related to body fat mass. The skeletal muscle mass did not change significantly, which indicates an actual decrease in the fat mass. The proportion of subjects who did not succeed in following the prescribed diet plan was 12%. The application of intermittent fasting in female subjects over 60 years of age resulted in positive changes in body composition. Time-restricted feeding (TRF) was characterized by a lower resignation rate compared to other diets involving intermittent fasting.",2020,Time-restricted feeding (TRF) was characterized by a lower resignation rate compared to other diets involving intermittent fasting.,"['Women over 60 Years of Age', 'female subjects over 60 years of age resulted in positive changes in body composition', 'overweight women over 60 years of age, which was assessed by the ratio of subjects who resigned from the diet plan', '45 women over 60 years of age']",['Six-Week Intermittent Fasting Intervention Program'],"['body weight', 'body fat and lowering body mass index', 'Time-restricted feeding (TRF', 'skeletal muscle mass']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4704881', 'cui_str': 'Intermittent Fasting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",,0.0208379,Time-restricted feeding (TRF) was characterized by a lower resignation rate compared to other diets involving intermittent fasting.,"[{'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Domaszewski', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Opole University of Technology, 45-758 Opole, Poland.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Konieczny', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Opole University of Technology, 45-758 Opole, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Pakosz', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Opole University of Technology, 45-758 Opole, Poland.'}, {'ForeName': 'Dawid', 'Initials': 'D', 'LastName': 'Bączkowicz', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Opole University of Technology, 45-758 Opole, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Sadowska-Krępa', 'Affiliation': 'Institute of Sport Sciences, the Jerzy Kukuczka Academy of Physical Education, 40-065 Katowice, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17114138']
1079,32540553,Metronomic oral chemotherapy with cyclophosphamide plus capecitabine combined with trastuzumab (HEX) as first line therapy of HER-2 positive advanced breast cancer: A phase II trial of the Gruppo Oncologico Italia Meridionale (GOIM).,"BACKGROUND


The combination of chemotherapy plus anti HER-2 agents is the mainstay of HER-2 positive advanced breast cancer (ABC) therapy. We conducted a phase II trial testing activity and safety of trastuzumab and metronomic capecitabine/cyclophosphamide (HEX) as first-line therapy in HER-2 positive ABC.
Methods. Patients at first relapse or with synchronous metastasis were treated with trastuzumab (4 mg/kg, biweekly) plus oral capecitabine (1500 mg/daily) and cyclophosphamide (50 mg/daily). Primary endpoint was objective response rate (ORR), secondary endpoints progression-free survival (PFS), clinical benefit rate (CBR; PR + CR + SD for ≥ 24 weeks) and tolerability. Optimal two-stage design was applied.
RESULTS


Sixty patients with measurable ABC, tumors scored as +3 for HER-2 or FISH +, untreated for advanced disease were enrolled. Median age was 62.5 years, visceral metastases were present in most patients (57.9%). Median number of cycles was 16 (range 1-98). ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%). Fifteen patients had SD (25%). The CBR was 78.2%. Nine progressions were observed (15%). Median PFS was 11 months. One year PFS was 47.7%. Median OS was 45.9 months. Worst toxicities were grade 3 hand-foot syndrome in 2 pts (3.3%), grade 3 anaemia in 2 pts (3.3%), grade 2 nausea in 2 pts (3.3%) and grade 3-4 diarrhea in 2 pts (3.3%). Cardiac toxicity grade 1 was reported in 1 pt.
CONCLUSIONS


Combination of trastuzumab and metronomic oral chemotherapy has clinical activity. The tolerability was excellent and allowed the prolonged delivery of treatment.",2020,"ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%).","['Patients at first relapse or with synchronous metastasis', 'HER-2 positive advanced breast cancer', 'HER-2 positive advanced breast cancer (ABC) therapy', 'Sixty patients with measurable ABC, tumors scored as\xa0+3 for HER-2 or FISH\xa0+, untreated for advanced disease were enrolled', 'Fifteen patients had SD (25']","['trastuzumab', 'cyclophosphamide', 'chemotherapy plus anti HER-2 agents', 'trastuzumab and metronomic capecitabine/cyclophosphamide (HEX', 'trastuzumab and metronomic oral chemotherapy', 'oral capecitabine', 'Metronomic oral chemotherapy with cyclophosphamide plus capecitabine combined with trastuzumab (HEX']","['Median PFS', 'grade 2 nausea', 'Median OS', 'Worst toxicities', 'grade 3 anaemia', 'ORR', 'objective response rate (ORR), secondary endpoints progression-free survival (PFS), clinical benefit rate (CBR; PR\xa0+\xa0CR\xa0+\xa0SD for\xa0≥\xa024 weeks) and tolerability', 'Cardiac toxicity grade 1', 'tolerability', 'Median number of cycles', 'visceral metastases', 'grade 3-4 diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0419073', 'cui_str': 'Oral chemotherapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",9.0,0.0480206,"ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%).","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Orlando', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy. Electronic address: laura.orlando68@gmail.com.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Lorusso', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giotta', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Di Maio', 'Affiliation': 'Department of Oncology, University of Turin at Ordine Mauriziano Hospital, Turin, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Schiavone', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Palma', 'Initials': 'P', 'LastName': 'Fedele', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Quaranta', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Caliolo', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Ciccarese', 'Affiliation': 'Medical Oncology, Ospedale Vito Fazzi, Lecce, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Cinefra', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Sante', 'Initials': 'S', 'LastName': 'Romito', 'Affiliation': 'Medical Oncology, Ospedali Riuniti, Foggia, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Pisconti', 'Affiliation': 'Medical Oncology, Ospedale Moscato, Taranto, Italy.'}, {'ForeName': 'Salvatore Del', 'Initials': 'SD', 'LastName': 'Prete', 'Affiliation': 'Medical Oncology, Ospedale San Giovanni di Dio, Frattamaggiore, Napoli, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Aieta', 'Affiliation': 'Medical Oncology, Ospedale Oncologico Regionale, Rionero in Vulture, Potenza, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Rizzi', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Evaristo', 'Initials': 'E', 'LastName': 'Maiello', 'Affiliation': 'Medical Oncology, Ospedale Sollievo Della Sofferenza, IRCCS, San Giovanni Rotondo, Foggia, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Colucci', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Cinieri', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.06.002']
1080,32540588,Deep transcranial magnetic stimulation for obsessive-compulsive disorder is efficacious even in patients who failed multiple medications and CBT.,"OCD is a chronic and disabling disease with a lifetime prevalence of 2%-3%. About 40-60% of these patients do not adequately respond to pharmacotherapy and CBT. Deep transcranial magnetic stimulation (dTMS) was shown to be safe and effective as a treatment alternative for OCD and recently received regulatory approvals. Yet it is unclear whether patients who failed numerous medications and/or CBT can still benefit from dTMS. Here, we analyzed recent data from a double-blind multicenter dTMS study and found efficacy of this novel treatment even in OCD patient cohorts who previously failed to respond to multiple medications and CBT.",2020,Deep transcranial magnetic stimulation (dTMS) was shown to be safe and effective as a treatment alternative for OCD and recently received regulatory approvals.,"['OCD patient cohorts who previously failed to respond to multiple medications and CBT', 'patients who failed multiple medications and CBT']","['OCD', 'Deep transcranial magnetic stimulation', 'Deep transcranial magnetic stimulation (dTMS']",[],"[{'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]",[],,0.0274375,Deep transcranial magnetic stimulation (dTMS) was shown to be safe and effective as a treatment alternative for OCD and recently received regulatory approvals.,"[{'ForeName': 'Yiftach', 'Initials': 'Y', 'LastName': 'Roth', 'Affiliation': 'The Department of Life Sciences and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Noam', 'Initials': 'N', 'LastName': 'Barnea-Ygael', 'Affiliation': 'The Department of Life Sciences and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Carmi', 'Affiliation': 'Chaim Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Storch', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Baylor College of Medicine, TX, USA.'}, {'ForeName': 'Aron', 'Initials': 'A', 'LastName': 'Tendler', 'Affiliation': 'Advanced Mental Health Care, Inc., Palm Beach, FL, USA.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Zangen', 'Affiliation': 'The Department of Life Sciences and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel. Electronic address: azangen@bgu.ac.il.'}]",Psychiatry research,['10.1016/j.psychres.2020.113179']
1081,32540624,Effects of night-time bicycling visibility aids on vehicle passing distance.,"Bicycling at night is dangerous, with vehicle passing distances being a key concern, given that the main cause of night-time bicycling fatalities is from motorists hitting bicyclists from behind. However, little is known about vehicle passing distances at night or how they are affected by bicyclist visibility. This study assessed the impact of different bicyclist visibility configurations on vehicle passing distances at night-time. Fourteen licenced drivers with normal vision (age 24.2 ± 3.7 years) drove an experimental vehicle with low-beam headlights around a 1-km section of a closed-road circuit at night. Each lap involved passing two bicyclists displaying one of four visibility configurations: Control (red rear-facing light and reflector), Handlebars (control plus two red rear-facing lights on each handlebar), Helmet (control plus one red rear-facing light on the helmet), and Leg Retro-reflectors (control plus retro-reflective strips positioned on the knees and ankles). Participants were instructed to pass each bicyclist at a distance of 1-metre at a speed no greater than 50 km/hr, consistent with Queensland's Minimum Passing Distance rule. Participants completed eight laps, two for each configuration, in a randomised sequence. Passing distance was measured using a vehicle-mounted ultra-sonic sensor (ToughSonic14; Senix). Following each lap, participants rated the difficulty level in judging the 1-metre passing distance, as well as their estimated passing distance. Visibility configuration significantly affected passing distance (p = 0.001), with wider passing distances for the Handlebar configuration (1.54 ± 0.62 m), followed by the Helmet (1.51 ± 0.63 m), Leg Retro-reflectors (1.50 ± 0.62 m) which were all significantly greater than the Control (1.42 ± 0.57 m), but not significantly different from each other. There was also a significant effect of visibility configuration on difficulty rating (p = 0.035), with the Control rated as the most difficult, followed by Helmet, Handlebars and Leg Retro-reflectors. Overall, additional visibility aids resulted in wider vehicle passing distances, likely due to enhanced visual cues for drivers. The findings suggest that bicyclists should incorporate additional visibility aids to encourage safer passing distances of vehicles at night-time.",2020,"Visibility configuration significantly affected passing distance (p = 0.001), with wider passing distances for the Handlebar configuration (1.54 ± 0.62 m), followed by the Helmet (1.51 ± 0.63 m), Leg Retro-reflectors (1.50 ± 0.62 m) which were all significantly greater than the Control (1.42 ± 0.57 m), but not significantly different from each other.",['Fourteen licenced drivers with normal vision (age 24.2\u202f±\u202f3.7 years) drove an experimental vehicle with low-beam headlights around a 1-km section of a closed-road circuit at night'],"['visibility configurations: Control (red rear-facing light and reflector), Handlebars (control plus two red rear-facing lights on each handlebar), Helmet (control plus one red rear-facing light on the helmet), and Leg Retro-reflectors (control plus retro-reflective strips positioned on the knees and ankles', 'night-time bicycling visibility aids']","['visibility configuration on difficulty rating', 'Leg Retro-reflectors']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0234622', 'cui_str': 'Normal vision'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]","[{'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018884', 'cui_str': 'Helmet'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}]",,0.0635457,"Visibility configuration significantly affected passing distance (p = 0.001), with wider passing distances for the Handlebar configuration (1.54 ± 0.62 m), followed by the Helmet (1.51 ± 0.63 m), Leg Retro-reflectors (1.50 ± 0.62 m) which were all significantly greater than the Control (1.42 ± 0.57 m), but not significantly different from each other.","[{'ForeName': 'Alex A', 'Initials': 'AA', 'LastName': 'Black', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia. Electronic address: aa.black@qut.edu.au.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Duff', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Hutchinson', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Ng', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Kirby', 'Initials': 'K', 'LastName': 'Phillips', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'Rose', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Ussher', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Wood', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105636']
1082,32682994,Time limited eating in adolescents with obesity (time LEAd): Study protocol.,"BACKGROUND


Time limited eating (TLE) has been shown to be effective for weight loss and improvement of glycemic control in adults with obesity and type 2 diabetes (T2D), but has not been well studied in adolescents. TLE may be a more feasible, flexible and effective dietary intervention for adolescents because it removes the need for intensive counting of calories or macronutrients, and emphasizes eating during a specified time period.
OBJECTIVES


The aim of this study is to assess the feasibility of a TLE approach in adolescents with obesity using a continuous glucose monitor (CGM) to promote adherence to the intervention.
METHODS


We propose a prospective, randomized controlled trial, in 60 adolescents (ages 14-18) with obesity (BMI% ≥ 95th percentile). Youth will be randomized to one of three treatment groups for a 12-week intervention: Group 1) Low sugar and carbohydrate education (LSC, 5% of total daily calories from sugar (<35 g)/day; <90 g carbohydrate (CHO)/day) + blinded CGM (used to monitor adherence and glycemic outcomes without real time feedback), Group 2) LSC + TLE (16-h fast/8-h feed for 5 days per week) + blinded CGM, and Group 3) LSC + TLE+ real time feedback via CGM (to evaluate effect of providing CGM data on intervention efficacy). Outcomes will include change in total body fat (TBF) percentage measured on DEXA scan, BMI status and fasting blood glucose at 12 weeks compared to baseline.
CONCLUSIONS


TLE is a potentially powerful lifestyle intervention that could be readily integrated into pediatric weight management programs to optimize their impact and accelerate healthy changes.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03954223.",2020,"TLE may be a more feasible, flexible and effective dietary intervention for adolescents because it removes the need for intensive counting of calories or macronutrients, and emphasizes eating during a specified time period.
","['60 adolescents (ages 14-18) with obesity (BMI%\u202f≥\u202f95th percentile', 'adolescents with obesity (time LEAd', 'adolescents with obesity using a', 'adults with obesity and type 2 diabetes (T2D']","['TLE approach', 'LSC\u202f+\u202fTLE', 'TLE', 'Low sugar and carbohydrate education (LSC, 5% of total daily calories from sugar (<35\u202fg)/day; <90\u202fg carbohydrate (CHO)/day)\u202f+\u202fblinded CGM', 'continuous glucose monitor (CGM']","['total body fat (TBF) percentage measured on DEXA scan, BMI status and fasting blood glucose']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332186', 'cui_str': 'Definite time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439175', 'cui_str': '% of total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}]","[{'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}]",,0.0740017,"TLE may be a more feasible, flexible and effective dietary intervention for adolescents because it removes the need for intensive counting of calories or macronutrients, and emphasizes eating during a specified time period.
","[{'ForeName': 'Alaina P', 'Initials': 'AP', 'LastName': 'Vidmar', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States of America. Electronic address: avidmar@chla.usc.edu.""}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': 'Goran', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States of America.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Naguib', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States of America.""}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Fink', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States of America.""}, {'ForeName': 'Choo Phei', 'Initials': 'CP', 'LastName': 'Wee', 'Affiliation': 'CTSI Biostatics Core, Saban Research Institute, Los Angeles, CA, United States of America.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hegedus', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States of America.""}, {'ForeName': 'Kelleen', 'Initials': 'K', 'LastName': 'Lopez', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States of America.""}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Gonzalez', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States of America.""}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Raymond', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106082']
1083,32545223,Impact of Molar Furcations on Photodynamic Therapy Outcomes: A 6-Month Split-Mouth Randomized Clinical Trial.,"The effectiveness of adjunctive photodynamic treatment (PDT) to non-surgical periodontal therapy has been shown to depend on initial periodontal status. As molar furcation involvement impairs healing response to non-surgical periodontal therapy, the aim of this study was to evaluate the impact of furcation involvement on PDT outcomes. Thirty-six patients suffering from severe chronic periodontitis were included in a 6-month split-mouth randomized clinical trial. PDT applications used the toluidine blue O and a light-emitting diode (LED) with a red spectrum. Repeated PDT applications were performed in addition to non-surgical periodontal treatment at baseline and at 3-months. Pocket probing depth (PPD), plaque index, bleeding on probing, and clinical attachment level were recorded at baseline, and again at 3- and 6-months. Furcation sites of molars were compared to other sites of molars and non-molars. Multilevel analysis showed no PDT effect in molar furcation sites while an additional significant reduction (odds ratio = 0.67) of pockets with PPD > 5 mm in other sites at 3-months was measured. PPD reduction appeared delayed in molar furcation sites treated with PDT. There is no additional apparent benefit to use PDT in molar furcation sites for the reduction of pockets with PPD > 5 mm contrary to other sites.",2020,There is no additional apparent benefit to use PDT in molar furcation sites for the reduction of pockets with PPD > 5 mm contrary to other sites.,['Thirty-six patients suffering from severe chronic periodontitis'],"['Molar Furcations', 'adjunctive photodynamic treatment (PDT']","['healing response', 'Photodynamic Therapy Outcomes', 'PPD reduction', 'Pocket probing depth (PPD), plaque index, bleeding on probing, and clinical attachment level', 'PDT effect in molar furcation sites']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}]","[{'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",36.0,0.0345002,There is no additional apparent benefit to use PDT in molar furcation sites for the reduction of pockets with PPD > 5 mm contrary to other sites.,"[{'ForeName': 'Aymeric', 'Initials': 'A', 'LastName': 'Courval', 'Affiliation': 'Department of Periodontology, Dental Faculty, University of Strasbourg, 67000 Strasbourg, France.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Harmouche', 'Affiliation': 'Department of Periodontology, Dental Faculty, University of Strasbourg, 67000 Strasbourg, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Mathieu', 'Affiliation': 'Department of Periodontology, Dental Faculty, University of Strasbourg, 67000 Strasbourg, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Petit', 'Affiliation': 'Department of Periodontology, Dental Faculty, University of Strasbourg, 67000 Strasbourg, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Huck', 'Affiliation': 'Department of Periodontology, Dental Faculty, University of Strasbourg, 67000 Strasbourg, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Séverac', 'Affiliation': 'Methodology and Biostatistics Group, Public Health Department, University Hospitals of Strasbourg, 67000 Strasbourg, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Davideau', 'Affiliation': 'Department of Periodontology, Dental Faculty, University of Strasbourg, 67000 Strasbourg, France.'}]",International journal of environmental research and public health,['10.3390/ijerph17114162']
1084,32683215,Intensive upper extremity training improved whole body movement control for children with unilateral spastic cerebral palsy.,"BACKGROUND


Children with unilateral spastic cerebral palsy (USCP) exhibit impaired bimanual coordination, gait control, and whole body movement control. Intensive upper extremity training has been found to be effective for improving upper extremity function. However, the effectiveness of the intensive upper extremity training on whole body movement control is not known.
RESEARCH QUESTION


The present study aimed to evaluate the effects of Constraint Induced Movement Therapy (CIMT) and Hand Arm Bimanual Intensive Therapy (HABIT) on bimanual coordination and gait control during a complex whole body task.
METHODS


Sixteen children with congenital hemiplegia (age 6-12 years; GMFCS: I-II, MACS: I-II) were randomly assigned to either CIMT or HABIT for 6 h per day training for 15 days. Children were asked to perform two whole body tasks (walking with and without a tray carrying) while 3-D kinematic analysis was performed before and after training.
RESULTS


After training, the HABIT group increased the symmetry in height of their hands during tray carrying (more leveled tray). Both CIMT and HABIT groups decreased the lateral motion of the tray. The CIMT group increased speed and stride length after training in both the walking and tray carrying tasks. Both groups also increased their minimum toe clearance (all p < 0.05).
SIGNIFICANCE


Two types of intensive upper extremity training have provided significant improvements to whole body movement control for children with USCP. Adhering to the specificity of practice concept, HABIT improved bimanual coordination after training during the whole body tray carrying tasks. Given extensive interactions between the upper and lower extremities in real-world activities, future studies should focus on the effects of such combined training.",2020,"Both groups also increased their minimum toe clearance (all p < 0.05).
","['children with unilateral spastic cerebral palsy', 'Children with unilateral spastic cerebral palsy (USCP', 'children with USCP', 'Sixteen children with congenital hemiplegia (age 6-12 years; GMFCS']","['CIMT or HABIT', 'Intensive upper extremity training improved whole body movement control', 'CIMT', 'Constraint Induced Movement Therapy (CIMT) and Hand Arm Bimanual Intensive Therapy (HABIT', 'intensive upper extremity training', 'Intensive upper extremity training']","['bimanual coordination and gait control', 'symmetry in height of their hands', 'speed and stride length', 'lateral motion of the tray', 'minimum toe clearance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0270805', 'cui_str': 'Hemiplegic cerebral palsy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0427083', 'cui_str': 'Control of movement'}]","[{'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0184054', 'cui_str': 'Tray'}, {'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",16.0,0.0108967,"Both groups also increased their minimum toe clearance (all p < 0.05).
","[{'ForeName': 'Ya-Ching', 'Initials': 'YC', 'LastName': 'Hung', 'Affiliation': 'Department of Family, Nutrition, and Exercise Sciences, Queens College, City University of New York, 65-30 Kissena Blvd, Flushing, NY 11367, USA. Electronic address: yaching.hung@qc.cuny.edu.'}, {'ForeName': 'Fawzia', 'Initials': 'F', 'LastName': 'Shirzad', 'Affiliation': 'Department of Family, Nutrition, and Exercise Sciences, Queens College, City University of New York, 65-30 Kissena Blvd, Flushing, NY 11367, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Saleem', 'Affiliation': 'Department of Family, Nutrition, and Exercise Sciences, Queens College, City University of New York, 65-30 Kissena Blvd, Flushing, NY 11367, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Gordon', 'Affiliation': 'Department of Biobehavioral Sciences, Teachers College, Columbia University, 525 West 120th Street, Box 199, NY 10027, USA.'}]",Gait & posture,['10.1016/j.gaitpost.2020.07.009']
1085,32556194,Indirect effect of oral azithromycin on the gut resistome of untreated children: a randomized controlled trial.,"BACKGROUND


Antibiotic use by one individual may affect selection for antimicrobial resistance in close contacts. Here we evaluated whether oral antibiotic treatment of one child within a household affected the gut resistome of an untreated cohabiting child.
METHODS


Households with at least two children <5 y of age were randomized in a 1:1 fashion to a 5d course of azithromycin or placebo. To evaluate indirect effects of azithromycin treatment on the gut resistome, we randomly assigned one child in the house to azithromycin and one to placebo. In placebo households, each child received placebo. We performed DNA sequencing of rectal swabs collected 5 d after the last antibiotic dose. We estimated risk ratios for the presence of genetic resistance determinants at the class level using modified Poisson models for children in azithromycin households compared with placebo households and assessed the composition of the resistome using permutational analysis of variance (PERMANOVA).
RESULTS


Of 58 children (n = 30 azithromycin households, n = 28 placebo households) with post-treatment rectal swabs, genetic resistance determinants were common but there was no significant difference at the class (p = 0.54 for macrolides) or gene (p = 0.94 for structure by PERMANOVA, p = 0.94 for diversity) level between untreated children in azithromycin households compared with placebo households.
CONCLUSIONS


The results are encouraging that one child's antibiotic use may not influence the resistome of another child. Trial registration: ClinicalTrials.gov NCT03187834.",2020,"RESULTS


Of 58 children (n = 30 azithromycin households, n = 28 placebo households) with post-treatment rectal swabs, genetic resistance determinants were common but there was no significant difference at the class (p = 0.54 for macrolides) or gene (p = 0.94 for structure by PERMANOVA, p = 0.94 for diversity) level between untreated children in azithromycin households compared with placebo households.
","['one child within a household affected the gut resistome of an untreated cohabiting child', 'untreated children', 'Households with at least two children', '58 children (n = 30']","['placebo', 'azithromycin', 'azithromycin or placebo', 'oral azithromycin']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0221179', 'cui_str': 'Cohabiting'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]",[],58.0,0.445207,"RESULTS


Of 58 children (n = 30 azithromycin households, n = 28 placebo households) with post-treatment rectal swabs, genetic resistance determinants were common but there was no significant difference at the class (p = 0.54 for macrolides) or gene (p = 0.94 for structure by PERMANOVA, p = 0.94 for diversity) level between untreated children in azithromycin households compared with placebo households.
","[{'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Francis I Proctor Foundation, 513 Parnassus Avenue, University of California, San Francisco, San Francisco, CA 94143, USA.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Hinterwirth', 'Affiliation': 'Francis I Proctor Foundation, 513 Parnassus Avenue, University of California, San Francisco, San Francisco, CA 94143, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Worden', 'Affiliation': 'Francis I Proctor Foundation, 513 Parnassus Avenue, University of California, San Francisco, San Francisco, CA 94143, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sié', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Rue Namory Keita, Nouna, Burkina Faso.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Dah', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Rue Namory Keita, Nouna, Burkina Faso.'}, {'ForeName': 'Lucienne', 'Initials': 'L', 'LastName': 'Ouermi', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Rue Namory Keita, Nouna, Burkina Faso.'}, {'ForeName': 'Boubacar', 'Initials': 'B', 'LastName': 'Coulibaly', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Rue Namory Keita, Nouna, Burkina Faso.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': 'Francis I Proctor Foundation, 513 Parnassus Avenue, University of California, San Francisco, San Francisco, CA 94143, USA.'}, {'ForeName': 'Cindi', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Francis I Proctor Foundation, 513 Parnassus Avenue, University of California, San Francisco, San Francisco, CA 94143, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Ruder', 'Affiliation': 'Francis I Proctor Foundation, 513 Parnassus Avenue, University of California, San Francisco, San Francisco, CA 94143, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation, 513 Parnassus Avenue, University of California, San Francisco, San Francisco, CA 94143, USA.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I Proctor Foundation, 513 Parnassus Avenue, University of California, San Francisco, San Francisco, CA 94143, USA.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Doan', 'Affiliation': 'Francis I Proctor Foundation, 513 Parnassus Avenue, University of California, San Francisco, San Francisco, CA 94143, USA.'}]",International health,['10.1093/inthealth/ihaa029']
1086,32553888,Effect of practical hyperoxic high-intensity interval training on exercise performance.,"This study investigated the effect of a practical hyperoxic high-intensity interval training (HIIT) on aerobic and anaerobic exercise capacity. Sixteen male athletes were randomized into 2 groups: normoxic HIIT (NHIIT, n = 8) group or hyperoxic HIIT (HHIIT, n = 8) group and trained for 3 weeks (2 days/week) on a cycle ergometer (2-min intervals, with 2-min rest between intervals) at maximal workload, which was obtained during a maximal graded exercise test under normoxia. All training sessions were performed until exhaustion. Participants performed maximal graded exercise, submaximal exercise, and 90-s maximal exercise tests before and after the training period. Maximal oxygen uptake (P < 0.01) increased significantly in both groups. Blood lactate curve during submaximal exercise improved significantly only in the HHIIT group (P < 0.01). Mean power output during maximal exercise increased significantly only in the HHIIT group (P = 0.02). This study demonstrated that a practical hyperoxic HHIIT might be effective for improving aerobic capacity and anaerobic performance.",2020,Blood lactate curve during submaximal exercise improved significantly only in the HHIIT group (P <  0.01).,['Sixteen male athletes'],"['normoxic HIIT (NHIIT, n\u2009=\u20098) group or hyperoxic HIIT (HHIIT, n\u2009=\u20098) group and trained for 3 weeks (2 days/week) on a cycle ergometer (2-min intervals, with 2-min rest between intervals) at maximal workload, which was obtained during a maximal graded exercise test under normoxia', 'maximal graded exercise, submaximal exercise, and 90-s maximal exercise tests', 'practical hyperoxic high-intensity interval training', 'practical hyperoxic high-intensity interval training (HIIT']","['Mean power output during maximal exercise', 'Blood lactate curve during submaximal exercise', 'Maximal oxygen uptake', 'aerobic capacity and anaerobic performance', 'aerobic and anaerobic exercise capacity', 'exercise performance']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",16.0,0.0253253,Blood lactate curve during submaximal exercise improved significantly only in the HHIIT group (P <  0.01).,"[{'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Kon', 'Affiliation': 'School of International Liberal Studies, Chukyo University, 101-2 Yagotohonmachi, Showa-ku, Nagoya, 466-8666, Japan; Department of Sports Sciences, Japan Institute of Sports Sciences, 3-15-1 Nishigaoka, Kita-ku, Tokyo, 115-0056, Japan. Electronic address: kon.michihiro@gmail.com.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Nakagaki', 'Affiliation': 'Department of Sports Sciences, Japan Institute of Sports Sciences, 3-15-1 Nishigaoka, Kita-ku, Tokyo, 115-0056, Japan; Department of Sports Sciences, Yamanashi Gakuin University, 2-4-5 Sakaori, Kofu, Yamanashi, 400-8575, Japan.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Ebi', 'Affiliation': 'Department of Sports Sciences, Japan Institute of Sports Sciences, 3-15-1 Nishigaoka, Kita-ku, Tokyo, 115-0056, Japan.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103481']
1087,32521556,A Randomized Trial of Voice-Generated Inpatient Progress Notes: Effects on Professional Fee Billing.,"BACKGROUND


Prior evaluations of automated speech recognition (ASR) to create hospital progress notes have not analyzed its effect on professional revenue billing codes. As ASR becomes a more common method of entering clinical notes, clinicians, hospital administrators, and payers should understand whether this technology alters charges associated with inpatient physician services.
OBJECTIVES


This study aimed to measure the difference in professional fee charges between using voice and keyboard to create inpatient progress notes.
METHODS


In a randomized trial of a novel voice with ASR system, called voice-generated enhanced electronic note system (VGEENS), to generate physician notes, we compared 1,613 notes created using intervention (VGEENS) or control (keyboard with template) created by 31 physicians. We measured three outcomes, as follows: (1) professional fee billing levels assigned by blinded coders, (2) number of elements within each note domain, and (3) frequency of organ system evaluations documented in review of systems (ROS) and physical exam.
RESULTS


Participants using VGEENS generated a greater portion of high-level (99233) notes than control users (31.8 vs. 24.3%,  p  < 0.01). After adjustment for clustering by author, the finding persisted; intervention notes were 1.43 times more likely (95% confidence interval [CI]: 1.14-1.79) to receive a high-level code. Notes created using voice contained an average of 1.34 more history of present illness components (95% CI: 0.14-2.54) and 1.62 more review of systems components (95% CI: 0.48-2.76). The number of physical exam components was unchanged.
CONCLUSION


Using this voice with ASR system as tested slightly increases documentation of patient symptom details without reliance on copy and paste and may raise physician charges. Increased provider reimbursement may encourage hospital and provider group to offer use of voice and ASR to create hospital progress notes as an alternative to usual methods.",2020,Notes created using voice contained an average of 1.34 more history of present illness components (95% CI: 0.14-2.54) and 1.62 more review of systems components (95% CI: 0.48-2.76).,[],"['1,613 notes created using intervention (VGEENS) or control (keyboard with template) created by 31 physicians', 'novel voice with ASR system, called voice-generated enhanced electronic note system (VGEENS', 'automated speech recognition (ASR']","['professional fee billing levels assigned by blinded coders, (2) number of elements within each note domain, and (3) frequency of organ system evaluations documented in review of systems (ROS) and physical exam', 'greater portion of high-level', 'number of physical exam components']",[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4317132', 'cui_str': 'Template'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0015751', 'cui_str': 'Fees'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0460002', 'cui_str': 'Body system structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0489633', 'cui_str': 'Review of systems'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",99233.0,0.0952634,Notes created using voice contained an average of 1.34 more history of present illness components (95% CI: 0.14-2.54) and 1.62 more review of systems components (95% CI: 0.48-2.76).,"[{'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'White', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle, Washington, United States.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle, Washington, United States.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Garrison', 'Affiliation': 'Department of Health Services, University of Washington School of Public Health, and Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington, United States.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Payne', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle, Washington, United States.'}]",Applied clinical informatics,['10.1055/s-0040-1713134']
1088,32524862,Effect of clarithromycin pre-treatment on the pharmacokinetics of metoclopramide after their simultaneous oral intake.,"OBJECTIVE


The objective of this study was to assess the influence of enzyme suppression on the values of various pharmacokinetic factors of orally administered metoclopramide.
METHOD


This study was conducted in two phases and a 4-week duration was adopted for drug washout. This randomized study involved 12 healthy human volunteers who received a single oral dose of metoclopramide 20 mg. After the washout period, volunteers received clarithromycin 500 mg two times per day for consecutive 5 days. On test day (fifth day), a single oral dose of metoclopramide 20 mg was also given to the volunteers, and collection of blood samples was conducted at pre-decided time points. Various pharmacokinetic parameters such as C max,  T max , and AUC 0-∞  of metoclopramide were determined by analyzing the blood samples using a validated HPLC-UV method.
RESULTS


Clarithromycin increased the mean values of C max , AUC 0-∞ , and T 1/2  of metoclopramide by 46%, 78.6%, and 9.8%, respectively.
CONCLUSION


Clarithromycin noticeably increased the concentration of plasma metoclopramide. This study's results provide  in vivo  confirmation of the CYP3A4 involvement in metoclopramide metabolism, in addition to CYP2D6. Therefore, metoclopramide pharmacokinetics may be clinically affected by clarithromycin and other potent enzyme inhibitors.",2020,"RESULTS


Clarithromycin increased the mean values of C max , AUC 0-∞  and T 1/2  of metoclopramide by 46%, 78.6%, and 9.8%, respectively.
",['twelve healthy human volunteers who received a single oral dose of'],"['metoclopramide 20 mg', 'metoclopramide', 'clarithromycin', 'Clarithromycin']","['mean values of C max , AUC 0-∞  and T 1/2  of metoclopramide', 'concentration of plasma metoclopramide', 'C max,  T max , and AUC 0-∞  of metoclopramide']","[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",12.0,0.034377,"RESULTS


Clarithromycin increased the mean values of C max , AUC 0-∞  and T 1/2  of metoclopramide by 46%, 78.6%, and 9.8%, respectively.
","[{'ForeName': 'Iram', 'Initials': 'I', 'LastName': 'Kaukab', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Bahauddin Zakariya University , Multan, Pakistan.'}, {'ForeName': 'Syed Nisar Hussain', 'Initials': 'SNH', 'LastName': 'Shah', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Bahauddin Zakariya University , Multan, Pakistan.'}, {'ForeName': 'Zelal Jaber', 'Initials': 'ZJ', 'LastName': 'Kharaba', 'Affiliation': 'Department of Clinical Sciences, College of Pharmacy, Al-Ain University of Science and Technology , Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Manal Ali', 'Initials': 'MA', 'LastName': 'Buabeid', 'Affiliation': 'Department of Clinical Sciences, Ajman University , United Arab Emirates.'}, {'ForeName': 'Yaseen Abd', 'Initials': 'YA', 'LastName': 'Alfoteih', 'Affiliation': 'Department of Dental Surgery, City University College of Ajman , Ajman, United Arab Emirates.'}, {'ForeName': 'Ghulam', 'Initials': 'G', 'LastName': 'Murtaza', 'Affiliation': 'Department of Pharmacy, COMSATS Institute of Information Technology , Lahore, Pakistan.'}]",Expert opinion on drug metabolism & toxicology,['10.1080/17425255.2020.1779699']
1089,32530523,"Patient-reported outcomes after 10-year follow-up of intensive, multifactorial treatment in individuals with screen-detected type 2 diabetes: the ADDITION-Europe trial.","AIMS


To present the longer-term impact of multifactorial treatment of type 2 diabetes on self-reported health status, diabetes-specific quality of life, and diabetes treatment satisfaction at 10-year follow up of the ADDITION-Europe trial.
METHODS


The ADDITION-Europe trial enrolled 3057 individuals with screen-detected type 2 diabetes from four centres [Denmark, the UK (Cambridge and Leicester) and the Netherlands], between 2001 and 2006. Participants were randomized at general practice level to intensive treatment or to routine care . The trial ended in 2009 and a 10-year follow-up was performed at the end of 2014. We measured self-reported health status (36-item Short-Form Health Survey and EQ-5D), diabetes-specific quality of life (Audit of Diabetes-Dependent Quality of Life questionnaire), and diabetes treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire) at different time points during the study period. A mixed-effects model was applied to estimate the effect of intensive treatment (intention-to-treat analyses) on patient-reported outcome measures for each centre. Centre-specific estimates were pooled using a fixed effects meta-analysis.
RESULTS


There was no difference in patient-reported outcome measures between the routine care and intensive treatment arms in this 10-year follow-up study [EQ-5D: -0.01 (95% CI -0.03, 0.01); Physical Composite Score (36-item Short-Form Health Survey): -0.27 (95% CI -1.11, 0.57), Audit of Diabetes-Dependent Quality of Life questionnaire: -0.01 (95% CI -0.11, 0.10); and Diabetes Treatment Satisfaction Questionnaire: -0.20 (95% CI -0.70, 0.29)].
CONCLUSIONS


Intensive, multifactorial treatment of individuals with screen-detected type 2 diabetes did not affect self-reported health status, diabetes-specific quality of life, or diabetes treatment satisfaction at 10-year follow-up compared to routine care.",2020,There was no difference in patient-reported outcome measures between the routine care and intensive treatment arms in this 10-year follow-up study [EQ-5D: -0.01,"['3057 individuals with screen-detected type 2 diabetes from four centres [Denmark, the UK (Cambridge and Leicester) and the Netherlands], between 2001 and 2006', 'individuals with screen-detected type 2 diabetes']",['intensive treatment or to routine care '],"['self-reported health status (36-item Short-Form Health Survey and EQ-5D), diabetes-specific quality of life (Audit of Diabetes-Dependent Quality of Life questionnaire), and diabetes treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire', 'Physical Composite Score (36-item Short-Form Health Survey', 'health status, diabetes-specific quality of life, or diabetes treatment satisfaction', 'Audit of Diabetes-Dependent Quality of Life questionnaire', 'Diabetes Treatment Satisfaction Questionnaire: -0.20', 'health status, diabetes-specific quality of life, and diabetes treatment satisfaction']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0451116', 'cui_str': 'Diabetes treatment satisfaction questionnaire'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",3057.0,0.0852594,There was no difference in patient-reported outcome measures between the routine care and intensive treatment arms in this 10-year follow-up study [EQ-5D: -0.01,"[{'ForeName': 'E-M', 'Initials': 'EM', 'LastName': 'Dalsgaard', 'Affiliation': 'Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sandbaek', 'Affiliation': 'Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Griffin', 'Affiliation': 'MRC Epidemiology Unit, Institute of Metabolic Science, School of Clinical Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'G E H M', 'Initials': 'GEHM', 'LastName': 'Rutten', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, University Medical Centre, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Irving', 'Affiliation': 'Primary Care Unit, Institute of Public Health, School of Clinical Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Vos', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, University Medical Centre, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Webb', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'Wareham', 'Affiliation': 'MRC Epidemiology Unit, Institute of Metabolic Science, School of Clinical Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Witte', 'Affiliation': 'Department of Public Health, Aarhus University, Aarhus, Denmark.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14342']
1090,32526916,Immediate Effects of Tibialis Anterior and Calf Muscle Taping on Center of Pressure Excursion in Chronic Stroke Patients: A Cross-Over Study.,"Stroke patients often have muscles spasticity, difficulty with posture control, and tend to fall. This study investigated the use of kinesiology tape for patients with spasticity of ankle muscles after stroke. This study had a randomized, repeated measures design, and evaluated the immediate effect of kinesiology tape on the center of pressure (COP) excursion when applied to the calf and tibialis anterior muscles in stroke survivors. We determined that the taping attachment direction affects the COP movement. Twenty subjects were randomly assigned to the tibialis anterior taping condition, calf taping condition, or nontaping condition. Condition excursion was assessed. The measured variables included the paretic side area, nonparetic side area, forward area, and backward area of COP. All evaluations were conducted immediately after taping. COP excursion for chronic stroke survivors improved after tibialis anterior and calf taping (p < 0.05). Calf taping conditions increased significantly in the forward area (p < 0.05), and tibialis anterior taping conditions increased significantly in the backward area (p < 0.05). Kinesiology tape immediately increased the forward and backward COP excursion for patients with stroke.",2020,"Calf taping conditions increased significantly in the forward area (p < 0.05), and tibialis anterior taping conditions increased significantly in the backward area (p < 0.05).","['Twenty subjects', 'patients with spasticity of ankle muscles after stroke', 'Chronic Stroke Patients', 'stroke survivors', 'patients with stroke']","['tibialis anterior taping condition, calf taping condition, or nontaping condition', 'Tibialis Anterior and Calf Muscle Taping', 'kinesiology tape']","['center of pressure (COP) excursion', 'COP excursion for chronic stroke survivors', 'forward and backward COP excursion', 'tibialis anterior taping conditions', 'Calf taping conditions', 'paretic side area, nonparetic side area, forward area, and backward area of COP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",20.0,0.0161572,"Calf taping conditions increased significantly in the forward area (p < 0.05), and tibialis anterior taping conditions increased significantly in the backward area (p < 0.05).","[{'ForeName': 'Shin Jun', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Gangdong University, 278, Daehak-gil, Gamgok-myeon, Eumseong-gun, Chungcheongbuk-do 27600, Korea.'}, {'ForeName': 'Tae-Hyun', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'NEULBOM Hospital 17, Poeun-daero 59 beon-gil, Suji-gu, Yongin-si, Gyeonggi-do 16864, Korea.'}, {'ForeName': 'Seunghue', 'Initials': 'S', 'LastName': 'Oh', 'Affiliation': 'Department of Physical Therapy, Graduate School, Dankook University, 119, Dandae-ro, Dongnam-gu, Cheonan-si, Chungnam 330-714, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17114109']
1091,32527120,Using medical comics to explore challenging everyday topics in medicine: lessons learned from teaching medical humanities.,"BACKGROUND


Studying medicine requires an extensive acquisition of knowledge, skills and attitudes. At the MedUni Vienna, this wide range of skills is strengthened by discussing aspects of medical humanities (MH) with medical students in their pre-clinical fifth study year. Medical comics (MCs), as a part of MH, offer the possibility to address challenging situations within medical settings through the use of graphic illustrations. Thus, patient stories as well as different perspectives of patients, caregivers, and medical staff can be addressed.
METHODS


A total of 506 medical students were randomly assigned to one of three MCs within a blended learning setting via the Moodle online learning platform. The medical students were instructed to reflect on the MC by answering three questions within one week. Depending on the MC assigned, the learning objectives were to (I) comprehend demands on a young doctor during a night shift, (II) reflect on a patient examination situation, or (III) recognize patients' physical and/or emotional needs. The word counts of the answers and the time spent online answering the questions in the learning platform were analyzed. This was followed by an analysis in which the answers and their content were rated on a three-point Likert scale (insufficient, sufficient, exceptional). Subsequently, an MH and MCs lecture was held that incorporated the medical students' reflections. After the lecture, a one-minute paper (OMP) survey comprising two questions was conducted on the learning platform.
RESULTS


Of the 506 medical students assigned the online task, 505 completed it. On average, each medical student wrote 110.87 words (SD: 78.54; range, 4.00-602.00) and spent 12.75 minutes (SD: 11.60) on the task. Of all the answers, 84% were rated as sufficient or exceptional. Two OMP questions: (I) ""What was the most important thing you learned today?"", and (II) ""What questions remain unanswered?"" were answered by the medical students. ""What was the most important thing you learned today?"" was answered by 78% (n=393) of the medical students with a profound statement. When asked ""What questions remain unanswered?"", 85% (n=429) of the medical students stated that nothing was left unanswered. All the answers included 154 positive and 28 negative comments on the lecture.
CONCLUSIONS


The study results indicate that medical students saw great potential in the use of MCs in medical teaching in terms of addressing challenging topics and reflecting on them deeply. This kind of blended learning (a form of learning in which the advantages of face-to-face events and e-learning are combined) successfully showed that medical students can gain a deeper understanding of MH and be inspired through the use of MCs.",2020,"On average, each medical student wrote 110.87 words (SD: 78.54; range, 4.00-602.00) and spent 12.75 minutes (SD: 11.60) on the task.","['506 medical students assigned the online task', '506 medical students', '78% (n=393) of the medical students with a profound statement']","['blended learning', 'MCs within a blended learning setting via the Moodle online learning platform']",[],"[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439808', 'cui_str': 'Profound'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C4505477', 'cui_str': 'Online Education'}]",[],506.0,0.014258,"On average, each medical student wrote 110.87 words (SD: 78.54; range, 4.00-602.00) and spent 12.75 minutes (SD: 11.60) on the task.","[{'ForeName': 'Eva Katharina', 'Initials': 'EK', 'LastName': 'Masel', 'Affiliation': 'Department of Internal Medicine I, Division of Palliative Care, Medical University of Vienna, Vienna, Austria. eva.masel@gmx.at.'}, {'ForeName': 'Feroniki', 'Initials': 'F', 'LastName': 'Adamidis', 'Affiliation': 'Department of Internal Medicine I, Division of Palliative Care, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kitta', 'Affiliation': 'Department of Internal Medicine I, Division of Palliative Care, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Gruebl', 'Affiliation': 'Department of Internal Medicine I, Division of Palliative Care, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Unseld', 'Affiliation': 'Department of Internal Medicine I, Division of Palliative Care, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Pavelka', 'Affiliation': 'Teaching Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Herbert Hans', 'Initials': 'HH', 'LastName': 'Watzke', 'Affiliation': 'Department of Internal Medicine I, Division of Palliative Care, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Zlabinger', 'Affiliation': 'Teaching Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Praschinger', 'Affiliation': 'Teaching Center, Medical University of Vienna, Vienna, Austria.'}]",Annals of palliative medicine,['10.21037/apm-20-261']
1092,32530814,An Internet-Based Intervention to Alleviate Stress During Social Isolation With Guided Relaxation and Meditation: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Psychophysiological stress and decreased well-being are relevant issues during prolonged social isolation periods. Relaxation practices may represent helpful exercises to cope with anxiety and stressful sensations.
OBJECTIVE


The aim of this research protocol is to test whether remote relaxation practices such as natural sounds, deep respiration, and body scan meditation promote relaxation and improved emotional state and reduce psychomotor activation and the preoccupation related to the coronavirus disease (COVID-19) pandemic.
METHODS


The study population will consist of 3 experimental groups that will randomly receive one of 3 internet-based audio clips containing a single session of guided breathing exercise, guided body scan exercise, or natural sounds. The participants will listen to the fully automated audio clip for 7 minutes and complete pre-post self-assessment scales on their perceived relaxation, psychomotor activation, level of worry associated with COVID-19, and emotional state. At the end of the session, the participants will also be asked to provide qualitative reports on their subjective experiences.
RESULTS


Analyses will be performed to test the differences in the efficacy of the different audio clips in an internet-based intervention on 252 participants (84 per group), investigating whether natural sounds or remote guided practices such as deep respiration and body scan meditation positively enhance the participants' perceived psychological state.
CONCLUSIONS


The study will provide information on if and to what extent guided practices can help in reducing psychological side effects related to social isolation during the COVID-19 pandemic.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/19236.",2020,"RESULTS


Analysis will test the difference in efficacy between audio clips in an internet-based intervention on 252 subjects (84 per group), investigating whether natural sounds or remote guided practices like deep respiration and body scan enhance in a positive way the perceived psychological state.
",['252 subjects (84 per group'],"['online audio clips containing a single session of guided breathing exercise, guided body scan exercise, or natural sounds', 'audio clips']","['relaxation, psychomotor activation, level of worries associated with COVID-19 and emotional state']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}]","[{'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}]",252.0,0.031618,"RESULTS


Analysis will test the difference in efficacy between audio clips in an internet-based intervention on 252 subjects (84 per group), investigating whether natural sounds or remote guided practices like deep respiration and body scan enhance in a positive way the perceived psychological state.
","[{'ForeName': 'Silvia Maria Francesca', 'Initials': 'SMF', 'LastName': 'Pizzoli', 'Affiliation': 'Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Marzorati', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, European Institute of Oncology (Istituto di Ricovero e Cura a Carattere Scientifico), Milan, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Mazzoni', 'Affiliation': 'Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Pravettoni', 'Affiliation': 'Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.'}]",JMIR research protocols,['10.2196/19236']
1093,32534120,Effect of traditional Chinese medicine formula GeGen decoction on primary dysmenorrhea: A randomized controlled trial study.,"ETHNOPHARMACOLOGICAL RELEVANCE


GeGen Decoction, a well-known Chinese herbal formula, is widely used in China and other Asian countries to treat gynecological diseases, including primary dysmenorrhea. Pharmacological studies have confirmed that GeGen Decoction is able to inhibit spasmodic contractions of the uterus in vivo and in vitro.
AIM OF THE STUDY


The objective of this study is to examine the efficacy and safety of GeGen Decoction on primary dysmenorrheic patients.
METHODS


This was a randomized, double-blinded, placebo-controlled trial. GeGen Decoction or placebo was administered a week before the expected start of each cycle for three consecutive menstrual periods. Between-group differences in pain intensity were detected by visual analogue scale (VAS). In addition, serum levels of arginine vasopressin (AVP) and estrogen (E) were examined by enzyme-linked immunosorbent assay. Metabolomic analysis was further used to evaluate the influence of GeGen Decoction on the metabolomics of primary dysmenorrheic patients.
RESULTS


A total of 71 primary dysmenorrheic women were recruited and 30 participants met the criteria were randomized into GeGen Decoction or placebo group. After three consecutive menstrual cycles' treatments, the VAS score of the GeGen Decoction group was significantly lower than that of the placebo group. Both serum levels of AVP and E decreased after GeGen Decoction administration, while the placebo seemed to have little effect on either of the index. Moreover, after GeGen Decoction treatment, seven important metabolites were identified by metabolomic analysis compared to the placebo group. No abnormalities in blood biochemical and routine physical examination pre and post GeGen Decoction intervention were observed.
CONCLUSIONS


GeGen Decoction can remarkably relieve the severity of menstrual pain without obvious adverse effects. Its therapeutic effect on primary dysmenorrhea might be related to the regulation of pituitary hypothalamic ovarian hormones, and interfering with the metabolic change.",2020,"After three consecutive menstrual cycles' treatment, the VAS score of the GeGen Decoction group was significantly lower than that of the placebo group.","['primary dysmenorrhea', 'primary dysmenorrheic patients', '71 primary dysmenorrheic women were recruited and 30 participants met the criteria']","['GeGen Decoction', 'traditional Chinese medicine formula GeGen decoction', 'GeGen Decoction or placebo', 'placebo']","['VAS score', 'pain intensity', 'blood biochemical and routine physical examination pre and post GeGen Decoction intervention', 'visual analogue scale (VAS', 'serum levels of arginine vasopressin (AVP) and estrogen (E', 'serum levels of AVP and E', 'efficacy and safety', 'severity of menstrual pain']","[{'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}]",71.0,0.369829,"After three consecutive menstrual cycles' treatment, the VAS score of the GeGen Decoction group was significantly lower than that of the placebo group.","[{'ForeName': 'Chengzhi', 'Initials': 'C', 'LastName': 'Chai', 'Affiliation': 'Jiangsu Provincial Key Laboratory for TCM Evaluation and Translational Development, School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu Province, 211198, PR China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Hong', 'Affiliation': 'Jiangsu Provincial Key Laboratory for TCM Evaluation and Translational Development, School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu Province, 211198, PR China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Shanxi University, Taiyuan, Shanxi Province, PR China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Jiangsu Provincial Key Laboratory for TCM Evaluation and Translational Development, School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu Province, 211198, PR China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zong', 'Affiliation': 'Hospital Affiliated to Shanxi University of Traditional Chinese Medicine, Taiyuan, Shanxi Province, PR China.'}, {'ForeName': 'Changsong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Traditional Chinese Medicine, Zhongda Hospital, Southeast University, Nanjing, Jiangsu Province, PR China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Traditional Chinese Medicine, Zhongda Hospital, Southeast University, Nanjing, Jiangsu Province, PR China. Electronic address: liuzhigang729@seu.edu.cn.'}, {'ForeName': 'Boyang', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Jiangsu Provincial Key Laboratory for TCM Evaluation and Translational Development, School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu Province, 211198, PR China. Electronic address: boyangyu59@163.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113053']
1094,32534221,The three-year effect of a single zoledronate infusion on bone mineral density and bone turnover markers following denosumab discontinuation in women with postmenopausal osteoporosis.,"INTRODUCTION


In women with postmenopausal osteoporosis denosumab discontinuation is associated with rapid bone loss that could be potentially prevented by a single zoledronate infusion for two years. The longer-term effects, however, of zoledronate treatment are unknown. We aimed to study the effect of a single zoledronate infusion during the third year following denosumab discontinuation, in initially treatment-naive postmenopausal women who became osteopenic after 2.4 ± 0.2 years of denosumab therapy.
METHODS


We report the 1-year follow-up results of a single arm observational extension of a previously reported 2-year multicenter prospective randomized clinical trial. The primary endpoint of this extension was the change in lumbar spine bone mineral density (LS-BMD); secondary endpoints were changes in femoral neck (FN)-BMD and markers of bone turnover (BTM) during the 3rd year from the zoledronate infusion. Changes are presented as mean and SEM.
RESULTS


LS-BMD did not change significantly at year 3 compared to year 2 (-1.35 ± 1.1%, p = 1.00) and compared to baseline (-1.96 ± 1.44%, p = 1.00). FN-BMD values did not change while serum P1NP values decreased and CTX values remained unchanged during the third-year of the follow-up. In 4 of the 23 studied women BMD values returned to the osteoporotic range at 3 years.
CONCLUSIONS


A single i.v. infusion of zoledronate 5 mg, given 6 months after the last injection of denosumab therapy maintains for three years BMD gains in the majority of patients previously treated with denosumab for an approximate period of 2.5 years. Follow-up of patients is, however, recommended because about one-fifth of treated women will require additional antiosteoporotic treatment.",2020,FN-BMD values did not change while serum P1NP values decreased and CTX values remained unchanged during the third-year of the follow-up.,"['women with postmenopausal osteoporosis', 'initially treatment-naive postmenopausal women who became osteopenic after 2.4\u202f±\u202f0.2\u202fyears of denosumab therapy']","['single zoledronate infusion', 'zoledronate infusion', 'denosumab', 'zoledronate', 'denosumab discontinuation']","['CTX values', 'femoral neck (FN)-BMD and markers of bone turnover (BTM', 'FN-BMD values', 'lumbar spine bone mineral density (LS-BMD', 'bone mineral density and bone turnover markers', 'LS-BMD']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal osteoporosis'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3839270', 'cui_str': 'Denosumab therapy'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0392938', 'cui_str': 'Zoledronate'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]","[{'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]",23.0,0.0926873,FN-BMD values did not change while serum P1NP values decreased and CTX values remained unchanged during the third-year of the follow-up.,"[{'ForeName': 'Polyzois', 'Initials': 'P', 'LastName': 'Makras', 'Affiliation': 'Department of Endocrinology and Diabetes and Department of Medical Research, 251 Hellenic Air Force & VA General Hospital, Athens, Greece.'}, {'ForeName': 'Socrates E', 'Initials': 'SE', 'LastName': 'Papapoulos', 'Affiliation': 'Center for Bone Quality, Department of Internal Medicine, Section Endocrinology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Stergios A', 'Initials': 'SA', 'LastName': 'Polyzos', 'Affiliation': 'First Laboratory of Pharmacology, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Natasha M', 'Initials': 'NM', 'LastName': 'Appelman-Dijkstra', 'Affiliation': 'Center for Bone Quality, Department of Internal Medicine, Section Endocrinology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Athanasios D', 'Initials': 'AD', 'LastName': 'Anastasilakis', 'Affiliation': 'Department of Endocrinology, 424 General Military Hospital, Thessaloniki, Greece. Electronic address: a.anastasilakis@gmail.com.'}]",Bone,['10.1016/j.bone.2020.115478']
1095,32534628,"Safety and immunogenicity of a mosquito saliva peptide-based vaccine: a randomised, placebo-controlled, double-blind, phase 1 trial.","BACKGROUND


In animal models, immunity to mosquito salivary proteins protects animals against mosquito-borne disease. These findings provide a rationale to vaccinate against mosquito saliva instead of the pathogen itself. To our knowledge, no vector salivary protein-based vaccine has been tested for safety and immunogenicity in humans. We aimed to assess the safety and immunogenicity of Anopheles gambiae saliva vaccine (AGS-v), a peptide-based vaccine derived from four A gambiae salivary proteins, in humans.
METHODS


In this randomised, placebo-controlled, double-blind, phase 1 trial, participants were enrolled at the National Institutes of Health Clinical Center in Bethesda, MD, USA. Participants were eligible if they were healthy adults, aged 18-50 years with no history of severe allergic reactions to mosquito bites. Participants were randomly assigned (1:1:1), using block randomisation and a computer-generated randomisation sequence, to treatment with either 200 nmol of AGS-v vaccine alone, 200 nmol of AGS-v with adjuvant (Montanide ISA 51), or sterile water as placebo. Participants and clinicians were masked to treatment assignment. Participants were given a subcutaneous injection of their allocated treatment at day 0 and day 21, followed by exposure to feeding by an uninfected Aedes aegypti mosquito at day 42 to assess subsequent risk to mosquito bites in a controlled setting. The primary endpoints were safety and immunogenicity at day 42 after the first immunisation. Participants who were given at least one dose of assigned treatment were assessed for the primary endpoints and analysis was by intention to treat. The trial was registered with ClinicalTrials.gov, NCT03055000, and is closed for accrual.
FINDINGS


Between Feb 15 and Sept 10, 2017, we enrolled and randomly assigned 49 healthy adult participants to the adjuvanted vaccine (n=17), vaccine alone (n=16), or placebo group (n=16). Five participants did not complete the two-injection regimen with mosquito feeding at day 42, but were included in the safety analyses. No systemic safety concerns were identified; however, one participant in the adjuvanted vaccine group developed a grade 3 erythematous rash at the injection site. Pain, swelling, erythema, and itching were the most commonly reported local symptoms and were significantly increased in the adjuvanted vaccine group compared with both other treatment groups (nine [53%] of 17 participants in the adjuvanted vaccine group, two [13%] of 16 in the vaccine only group, and one [6%] of 16 in the placebo group; p=0·004). By day 42, participants who were given the adjuvanted vaccine had a significant increase in vaccine-specific total IgG antibodies compared with at baseline than did participants who were give vaccine only (absolute difference of log 10 -fold change of 0·64 [95% CI 0·39 to 0·89]; p=0·0002) and who were given placebo (0·62 [0·34 to 0·91]; p=0·0001). We saw a significant increase in IFN-γ production by peripheral blood mononuclear cells at day 42 in the adjuvanted vaccine group compared with in the placebo group (absolute difference of log 10  ratio of vaccine peptide-stimulated vs negative control 0·17 [95% CI 0·061 to 0·27]; p=0·009) but we saw no difference between the IFN-γ production in the vaccine only group compared with the placebo group (0·022 [-0·072 to 0·116]; p=0·63).
INTERPRETATION


AGS-v was well tolerated, and, when adjuvanted, immunogenic. These findings suggest that vector-targeted vaccine administration in humans is safe and could be a viable option for the increasing burden of vector-borne disease.
FUNDING


Office of the Director and the Division of Intramural Research at the National Institute of Allergy and Infectious Diseases, and National Institutes of Health.",2020,We saw a significant increase in IFN-γ production by peripheral blood mononuclear cells at day 42 in the adjuvanted vaccine group compared with in the placebo group (absolute difference of log 10  ratio of vaccine peptide-stimulated vs negative control 0·17,"['Participants were eligible if they were healthy adults, aged 18-50 years with no history of severe allergic reactions to mosquito bites', '49 healthy adult participants to the adjuvanted vaccine (n=17', 'Between Feb 15 and Sept 10, 2017', 'participants were enrolled at the National Institutes of Health Clinical Center in Bethesda, MD, USA']","['AGS-v vaccine alone, 200 nmol of AGS-v with adjuvant (Montanide ISA 51), or sterile water as placebo', 'vaccine alone', 'Anopheles gambiae saliva vaccine (AGS-v), a peptide-based vaccine', 'mosquito saliva peptide-based vaccine', 'placebo']","['Safety and immunogenicity', 'vaccine-specific total IgG antibodies', 'Pain, swelling, erythema, and itching', 'grade 3 erythematous rash', 'IFN-γ production', 'safety and immunogenicity', 'IFN-γ production by peripheral blood mononuclear cells']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0417744', 'cui_str': 'Mosquito bite'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439191', 'cui_str': 'nmol'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C1311732', 'cui_str': 'montanide ISA 51'}, {'cui': 'C0359299', 'cui_str': 'sterile water'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4047355', 'cui_str': 'Mosquito saliva'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0234913', 'cui_str': 'Rash erythematous'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}]",49.0,0.7465,We saw a significant increase in IFN-γ production by peripheral blood mononuclear cells at day 42 in the adjuvanted vaccine group compared with in the placebo group (absolute difference of log 10  ratio of vaccine peptide-stimulated vs negative control 0·17,"[{'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Manning', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institutes of Health, Bethesda, MD, USA. Electronic address: jessica.manning@nih.gov.'}, {'ForeName': 'Fabiano', 'Initials': 'F', 'LastName': 'Oliveira', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Iliano V', 'Initials': 'IV', 'LastName': 'Coutinho-Abreu', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Herbert', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Meneses', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Shaden', 'Initials': 'S', 'LastName': 'Kamhawi', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Holly Ann', 'Initials': 'HA', 'LastName': 'Baus', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Han', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Czajkowski', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Luz Angela', 'Initials': 'LA', 'LastName': 'Rosas', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Cervantes-Medina', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Rani', 'Initials': 'R', 'LastName': 'Athota', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Reed', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Allyson', 'Initials': 'A', 'LastName': 'Mateja', 'Affiliation': 'Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, sponsored by the National Cancer Institute, National Institutes of Health, Frederick, MD, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hunsberger', 'Affiliation': 'Biostatistics Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'James', 'Affiliation': 'SEEK, PepTcell, London, UK.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Pleguezuelos', 'Affiliation': 'SEEK, PepTcell, London, UK.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Stoloff', 'Affiliation': 'SEEK, PepTcell, London, UK.'}, {'ForeName': 'Jesus G', 'Initials': 'JG', 'LastName': 'Valenzuela', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Memoli', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31048-5']
1096,32536538,Palatal needle-free anesthesia for upper molars extraction. A randomized clinical trial.,"BACKGROUND


The aim of this study was to compare the ability of liposomal and non-liposomal lidocaine and prilocaine in hydrogel formulations to promote topical anesthesia in palatal mucosa during upper molar extractions.
METHODS


In this randomized, cross over, triple-blinded clinical trial, a liposomal and a non-liposomal formulation of the eutectic mixture of local anesthetics, 2.5% lidocaine and 2.5% prilocaine, were used to promote palatal anesthesia without the local anesthetic infiltration during bilateral upper molars extractions.
RESULTS


From the total of 40 patients included in this study, the non-liposomal eutectic lidocaine-prilocaine formulation failed in 40% of cases, unlike the liposomal formulation, which was effective for all patients (Fisher's exact test, p < 0.0001). Furthermore, the liposomal formulation (26.75 ± 7,47 min) induced longer anesthesia duration (t-test, p < 0.0001) than the non-liposomal formulation (16.78 ± 4.75 min). No mucosal ulceration or discomfort was reported for both formulations.
CONCLUSION


The liposomal formulation was able to induce adequate anesthesia in palatal mucosa during dental extraction, avoiding the local anesthetic infiltration. For the first time, a topical formulation allowed upper molars surgical removal without injection of any local anesthetic agent into palatal mucosa in adults.",2020,"The liposomal formulation was able to induce adequate anesthesia in palatal mucosa during dental extraction, avoiding the local anesthetic infiltration.","['palatal mucosa during upper molar extractions', 'adults']","['liposomal and a non-liposomal formulation of the eutectic mixture of local anesthetics, 2.5% lidocaine and 2.5% prilocaine', 'Palatal needle-free anesthesia', 'liposomal and non-liposomal lidocaine and prilocaine', 'lidocaine-prilocaine']","['longer anesthesia duration', 'mucosal ulceration or discomfort']","[{'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0059079', 'cui_str': 'Eutectic Mixture of Local Anesthetics'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0617623', 'cui_str': 'Lidocaine- and prilocaine-containing product'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0236053', 'cui_str': 'Mucosal ulcer'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",40.0,0.116154,"The liposomal formulation was able to induce adequate anesthesia in palatal mucosa during dental extraction, avoiding the local anesthetic infiltration.","[{'ForeName': 'Klinger de Souza', 'Initials': 'KS', 'LastName': 'Amorim', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, 901 Limeira Avenue, 13414-903, Piracibaba, São Paulo, Brazil. Electronic address: klinger.amorim@outlook.com.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Franz-Montan', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, 901 Limeira Avenue, 13414-903, Piracibaba, São Paulo, Brazil.'}, {'ForeName': 'Francisco Carlos', 'Initials': 'FC', 'LastName': 'Groppo', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, 901 Limeira Avenue, 13414-903, Piracibaba, São Paulo, Brazil.'}, {'ForeName': 'Bruno Vilela', 'Initials': 'BV', 'LastName': 'Muniz', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, 901 Limeira Avenue, 13414-903, Piracibaba, São Paulo, Brazil.'}, {'ForeName': 'Jaiza Samara Macena de', 'Initials': 'JSM', 'LastName': 'Araújo', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, 901 Limeira Avenue, 13414-903, Piracibaba, São Paulo, Brazil.'}, {'ForeName': 'José Vânison Ferreira', 'Initials': 'JVF', 'LastName': 'Santana', 'Affiliation': 'Federal University of Sergipe, Oral Surgery and Anesthesiology Area of Dentistry Department, St Cláudio Batista, 49060-108, Aracaju, Cidade Nova, Sergipe, Brazil.'}, {'ForeName': 'Anne Caroline Gercina Carvalho', 'Initials': 'ACGC', 'LastName': 'Dantas', 'Affiliation': 'Federal University of Sergipe, Oral Surgery and Anesthesiology Area of Dentistry Department, St Cláudio Batista, 49060-108, Aracaju, Cidade Nova, Sergipe, Brazil.'}, {'ForeName': 'Eneida', 'Initials': 'E', 'LastName': 'de Paula', 'Affiliation': 'Biochemistry and Tissue Biology Department, Biology Institute, University of Campinas, St Monteiro Lobato 255, 13083-862, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Liane Maciel de Almeida', 'Initials': 'LMA', 'LastName': 'Souza', 'Affiliation': 'Federal University of Sergipe, Oral Surgery and Anesthesiology Area of Dentistry Department, St Cláudio Batista, 49060-108, Aracaju, Cidade Nova, Sergipe, Brazil.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2020.05.001']
1097,32536587,Effect of Pretreatment and Activation Mode on the Interfacial Adaptation of Nanoceramic Resin Inlay and Self-adhesive Resin Cement.,"OBJECTIVES


The first objective of this study was to determine if the luting material used for resin nanoceramic inlay affects interfacial adaptation. The second was to investigate whether pretreatment and the adhesive curing method before cementation affects interfacial adaptation. The final objective was to compare activation modes of luting material.
METHODS


Class I cavities were prepared on extracted human third molars. Resin nanoceramic inlays were fabricated using Lava Ultimate CAD/CAM block (3 M). For the control groups, inlays were cemented using Panavia V5 (Kuraray Noritake). For the experimental groups, teeth were randomly divided into five experimental groups with four subgroups using different self-adhesive cements (SACs). Cement in Group I was dual-cured without pretreatment. In Group II, the cement was dual-cured after polyacrylic acid treatment of the tooth cavity. In Groups III and IV, the cement was dual-cured after universal dentin adhesive treatment with pre-cure and co-cure methods. In Group V, the inlay was cemented in self-cure mode. After thermocycling, interfacial adaptation at the inlay-tooth interface was measured using swept-source optical coherence tomography (SS-OCT) imaging. Finally, polymerization shrinkage strain of the luting material was measured and compared.
RESULTS


Interfacial adaptation differed depending on the luting material. After application of a universal adhesive, some subgroups showed improved interfacial adaptation. Interfacial adaptation and polymerization shrinkage strain differed significantly depending on activation mode.
SIGNIFICANCE


Interfacial adaptation for a resin nanoceramic inlay can differ according to the type of SAC and activation mode. For some SACs, application of a universal adhesive before cementation improves interfacial adaptation.",2020,"Interfacial adaptation and polymerization shrinkage strain differed significantly depending on activation mode.
","['Class', 'Nanoceramic Resin Inlay and Self-adhesive Resin Cement']",['self-adhesive cements (SACs'],"['interfacial adaptation', 'Interfacial adaptation and polymerization shrinkage strain']","[{'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0376523', 'cui_str': 'Resin Cement'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0382302', 'cui_str': 'Adhesive cement'}]","[{'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0314672', 'cui_str': 'Polymerization'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}]",,0.0172676,"Interfacial adaptation and polymerization shrinkage strain differed significantly depending on activation mode.
","[{'ForeName': 'Seung-Hoon', 'Initials': 'SH', 'LastName': 'Han', 'Affiliation': 'Department of Conservative Dentistry, St. Vincent Hospital, College of Medicine, The Catholic University of Korea, 93 Jungbu-daero, Paldal-gu, Suwon, Gyeonggi-do, South Korea. Electronic address: han7537@hotmail.com.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Shimada', 'Affiliation': 'Department of Operative Dentistry, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525, Japan; Department of Cariology and Operative Dentistry, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-0034 Japan. Electronic address: shimada.ope@okayama-u.ac.jp.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Sadr', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, University of Washington, 1959 NE Pacific St, B162, Seattle, WA, 98195 USA. Electronic address: arsadr@uw.edu.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Tagami', 'Affiliation': 'Department of Cariology and Operative Dentistry, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-0034 Japan. Electronic address: tagami.ope@tmd.ac.jp.'}, {'ForeName': 'Kee-Yeon', 'Initials': 'KY', 'LastName': 'Kum', 'Affiliation': 'Department of Conservative Dentistry, Dental Research Institute, National Dental Care Center for Persons with Special Needs, Seoul National University Dental Hospital, Seoul National University School of Dentistry, 101 Daehak-ro, Jongno-gu, Seoul, 08030, Republic of Korea. Electronic address: kum6139@snu.ac.kr.'}, {'ForeName': 'Sung-Ho', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Department of Conservative Dentistry, Oral Science Research Center, College of Dentistry, Yonsei University, #50 Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea. Electronic address: sunghopark@yuhs.ac.'}]",Dental materials : official publication of the Academy of Dental Materials,['10.1016/j.dental.2020.05.005']
1098,32683106,Effect of combined exercise training on pentraxins and pro- inflammatory cytokines in people with multiple sclerosis as a function of disability status.,"OBJECTIVES


There is some evidence for beneficial effects of exercise on cytokines in people with multiple sclerosis (MS), but it is unclear if such effects differ by disability status (i.e., stage of the disease). This study investigated the effect of combined exercise training on pentraxins and pro- inflammatory cytokines in people with multiple sclerosis as a function of disability status.
METHODS


This randomized control trial included 94 women with MS who were randomly assigned into exercise or control conditions with randomization stratified by Expanded Disability Status Scale (EDSS) scores of low (EDSS < 4.5), moderate (4.5 ≤ EDSS ≤ 6), or high (EDSS ≥ 6.5) disability. The exercise program lasted 12 weeks and comprised resistance, endurance, Pilates, balance and stretch exercises performed? days/week; the control condition involved a waitlist control. We measured resting levels of inflammatory factors, functional capacity, and lipid profile before and after the 12-week intervention period.
RESULTS


Combined exercise training significantly decreased hs-CRP (p = 0.029) and IL-6 (p = 0.001) and increased PTX-3 (p = 0.001) and IFN-ƴ (p = 0.001), but there was no significant change in Fibrin D-dimer (FDD) (p = 0.876) compared with control, and those effects were independent of disability status. 1RM for lat pull-down, knee extension, and seated row and 6MWT (i.e., walking further) significantly increased and TUG performance significantly decreased (i.e., faster performance) (all, p < 0.001) after combined exercise compared with control, and this too was independent of disability status.
CONCLUSIONS


Exercise may stimulate anti-inflammatory effects in MS, and this is generally not influenced by disability status. Exercise training may be an adjuvant for disease-modifying therapy among people with MS, and such effects might not be moderated by disability status.",2020,"RESULTS


Combined exercise training significantly decreased hs-CRP (p = 0.029) and IL-6 (p = 0.001) and increased PTX-3 (p = 0.001) and IFN-ƴ (p = 0.001), but there was no significant change in Fibrin D-dimer (FDD) (p = 0.876) compared with control, and those effects were independent of disability status.","['people with multiple sclerosis', '94 women with MS', 'people with multiple sclerosis (MS']","['Combined exercise training', 'exercise or control conditions with randomization stratified by Expanded Disability Status Scale (EDSS) scores of low (EDSS\xa0<\xa04.5), moderate (4.5\xa0≤', 'exercise program lasted 12\xa0weeks and comprised resistance, endurance, Pilates, balance and stretch exercises performed', 'Exercise training', 'combined exercise training']","['Fibrin D-dimer (FDD', 'resting levels of inflammatory factors, functional capacity, and lipid profile', 'faster performance', 'TUG performance', 'pentraxins and pro- inflammatory cytokines', 'PTX-3', 'IL-6', 'hs-CRP']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",94.0,0.0328348,"RESULTS


Combined exercise training significantly decreased hs-CRP (p = 0.029) and IL-6 (p = 0.001) and increased PTX-3 (p = 0.001) and IFN-ƴ (p = 0.001), but there was no significant change in Fibrin D-dimer (FDD) (p = 0.876) compared with control, and those effects were independent of disability status.","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran. Electronic address: farmarzi@sku.ac.ir.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Banitalebi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Raisi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Samieyan', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Saberi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mardaniyan Ghahfarrokhi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Raoof', 'Initials': 'R', 'LastName': 'Negaresh', 'Affiliation': 'Department of Physical Education & Sport Sciences, Faculty of Humanities, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",Cytokine,['10.1016/j.cyto.2020.155196']
1099,32554218,Potential benefits of environmental volunteering programs of the health of older adults: a pilot study.,"PURPOSE


To study the effects of participating in a 12-week environmental volunteering program on the physical performance of older adults across different age groups MATERIALS AND METHODS: We conducted a pretest-posttest pilot study with a single group. The intervention consisted of twice-weekly recycling activities and once-weekly rehabilitation exercise at community-based care centers. The recycling activities of the environmental volunteering program included sorting and handling paper products, plastics, and metals; disposing electronic products; and sorting clothes. The rehabilitation exercise program comprised a 90-min course for special needs and 30 min of health education. The evaluation tools were the handgrip strength, five-times-sit-to-stand test, sit-and-reach test, Timed Up and Go (TUG) test and usual and fast gait speeds.
RESULTS


In total, 45 participants completed the program. After the program, the participants showed significantly great improvements compared to baseline in all outcome measures. We further divided these participants into two age subgroups [65-75 years (n = 31) and >75 years (n = 14)]. The 65-75-year subgroup only showed significant improvements in handgrip strength, TUG and usual gait speed. However, the >75-year subgroup showed significant improvements in all outcome measures.
CONCLUSIONS


This innovative environmental volunteering program conducted in a local Taiwanese community can be a sustainable and feasible model to improve physical performance in the participants, the subgroup aged >75 years in particular. It also provides a potential avenue for researchers and policymakers to address environmental and aging-related issues.",2020,"The 65-75-year subgroup only showed significant improvements in handgrip strength, TUG and usual gait speed.","['older adults across different age groups', 'older adults', 'participants into two age subgroups [65-75 years (n\u2009=\u200931) and >75 years (n\u2009=\u200914', 'participants, the subgroup aged >75 years in particular', '45 participants completed the program']","['twice-weekly recycling activities and once-weekly rehabilitation exercise at community-based care centers', 'rehabilitation exercise program', 'environmental volunteering program', 'environmental volunteering programs']","['handgrip strength, TUG and usual gait speed', 'handgrip strength, five-times-sit-to-stand test, sit-and-reach test, Timed Up and Go (TUG) test and usual and fast gait speeds']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0282114', 'cui_str': 'Recycling'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",45.0,0.0265483,"The 65-75-year subgroup only showed significant improvements in handgrip strength, TUG and usual gait speed.","[{'ForeName': 'Jia-Ching', 'Initials': 'JC', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan; Department of Physical Therapy, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Qi-Xing', 'Initials': 'QX', 'LastName': 'Chang', 'Affiliation': 'Department of Rehabilitation Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Chung-Chao', 'Initials': 'CC', 'LastName': 'Liang', 'Affiliation': 'Department of Rehabilitation Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan; Department of Medicine, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Jyh-Gang', 'Initials': 'JG', 'LastName': 'Hsieh', 'Affiliation': 'Department of Family Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Peter Pin-Sung', 'Initials': 'PP', 'LastName': 'Liu', 'Affiliation': 'Center for Aging and Health, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Chia-Feng', 'Initials': 'CF', 'LastName': 'Yen', 'Affiliation': 'Department of Public Health, Tzu Chi University, Hualien, Taiwan. Electronic address: mapleyeng@gmail.com.'}, {'ForeName': 'Ching-Hui', 'Initials': 'CH', 'LastName': 'Loh', 'Affiliation': 'Department of Family Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan; Center for Aging and Health, Buddhist Tzu Chi General Hospital, Hualien, Taiwan. Electronic address: twdoc1960@gmail.com.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104113']
1100,32561468,Enhancing prolonged exposure therapy for PTSD among veterans with oxytocin: Design of a multisite randomized controlled trial.,"Posttraumatic stress disorder (PTSD) is the most highly prevalent mental health disorder among U.S. military Veterans. Prolonged Exposure (PE) therapy is one of the most widely used evidence-based treatments for PTSD, but there is substantial room for improvement in outcomes and retention rates. Accumulating data suggest that oxytocin offers a promising pharmacological approach towards achieving this goal. Therefore, the primary objective of this two-site Phase II study is to examine the ability of oxytocin (vs. placebo) administration combined with PE therapy to (1) reduce PTSD symptom severity, (2) accelerate the rate of PTSD symptom improvement, and (3) improve PE adherence and retention rates. To accomplish these objectives, we will employ a randomized, double-blind, placebo-controlled trial and use standardized, repeated dependent measures of change at five time points (baseline, mid-treatment, end of treatment, and 3 and 6 month follow-up). Intranasal oxytocin (40 IU) will be administered directly prior to each PE therapy session. Findings from this study will provide critical new information regarding the efficacy of oxytocin to augment psychosocial treatment for PTSD, as well as information regarding the physiological mechanisms underlying PTSD and positive treatment response. ClinicalTrials.gov Identifier: NCT04228289.",2020,"Findings from this study will provide critical new information regarding the efficacy of oxytocin to augment psychosocial treatment for PTSD, as well as information regarding the physiological mechanisms underlying PTSD and positive treatment response.","['Posttraumatic stress disorder (PTSD', 'PTSD among veterans with']","['Prolonged Exposure (PE) therapy', 'oxytocin', 'oxytocin (vs. placebo) administration combined with PE therapy', 'Intranasal oxytocin', 'placebo']","['PTSD symptom severity, (2) accelerate the rate of PTSD symptom improvement, and (3) improve PE adherence and retention rates']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.421747,"Findings from this study will provide critical new information regarding the efficacy of oxytocin to augment psychosocial treatment for PTSD, as well as information regarding the physiological mechanisms underlying PTSD and positive treatment response.","[{'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: hellmuth@musc.edu.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Mitchell', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; Department of Neurology, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: jennifer.mitchell@ucsf.edu.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Department of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: bakern@musc.edu.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Woolley', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: josh.woolley@ucsf.edu.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Wangelin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: bethany.wangelin@va.gov.'}, {'ForeName': 'Sudie E', 'Initials': 'SE', 'LastName': 'Back', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: backs@musc.edu.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'McQuaid', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: john.mcquaid@va.gov.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Neylan', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; Department of Neurology, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: thomas.neylan@ucsf.edu.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Wolfe', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: william.wolfe@ucsf.edu.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: bradykt@musc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106074']
1101,32562670,Extended short-term follow-up for a trial of treatment of unruptured arteriovenous malformations.,,2020,,[],[],[],[],[],[],,0.0181838,,"[{'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Rothwell', 'Affiliation': 'Wolfson Centre for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences, University of Oxford, John Radcliffe Hospital, Oxford, OX3 9DU, UK. Electronic address: peter.rothwell@ndcn.ox.ac.uk.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30178-2']
1102,32563171,Adjunctive perampanel and myoclonic and absence seizures: Post hoc analysis of data from study 332 in patients with idiopathic generalized epilepsy.,"PURPOSE


This post hoc analysis assessed the effects of adjunctive perampanel on myoclonic and absence seizure outcomes in patients (aged ≥12 years) with idiopathic generalized epilepsy (IGE) and generalized tonic-clonic seizures during the double-blind (up to 8 mg/day) and open-label extension (OLEx; up to 12 mg/day) phases of Study 332.
METHODS


Patients experiencing myoclonic and/or absence seizures during study baseline were included. Assessments for myoclonic and absence seizures included: median percent change in seizure frequency, number of seizure days and seizure-free days (all per 28 days), 50 % and 75 % responder rates, seizure-freedom rates, seizure worsening, and monitoring of treatment-emergent adverse events (TEAEs).
RESULTS


During the double-blind phase, myoclonic and/or absence seizures were reported in 47/163 and 60/163 patients, respectively. Median percent reductions in seizure frequency per 28 days from study baseline were 52.5% and 24.5% (myoclonic seizures) and 7.6 % and 41.2 % (absence seizures) for placebo and perampanel, respectively; seizure-freedom rates were 13.0 % and 16.7 % (myoclonic seizures) and 12.1 % and 22.2 % (absence seizures), respectively. During the OLEx phase, 46/138 and 52/138 patients experienced myoclonic and/or absence seizures, respectively. Responses during the double-blind phase were maintained during long-term (>104 weeks) adjunctive perampanel treatment. The frequency/type of TEAEs was consistent with the known safety profile of perampanel.
CONCLUSION


In this post hoc analysis, adjunctive perampanel was not associated with any overall worsening of absence seizures. Further research is needed to investigate the effect of adjunctive perampanel in IGE patients with myoclonic and/or absence seizures.",2020,"In this post hoc analysis, adjunctive perampanel was not associated with any overall worsening of absence seizures.","['and myoclonic and absence seizures', 'patients (aged ≥12 years) with idiopathic generalized epilepsy (IGE) and generalized tonic-clonic seizures during the double-blind (up to 8 mg/day) and open-label extension (OLEx; up to 12 mg/day) phases of Study 332', 'Patients experiencing myoclonic and/or absence seizures during study baseline were included', 'patients with idiopathic generalized epilepsy', 'IGE patients with myoclonic and/or absence seizures']","['Adjunctive perampanel', 'adjunctive perampanel', 'placebo']","['responder rates, seizure-freedom rates, seizure worsening, and monitoring of treatment-emergent adverse events (TEAEs', 'seizure frequency', 'overall worsening of absence seizures', 'myoclonic and/or absence seizures', 'seizure frequency, number of seizure days and seizure-free days', 'seizure-freedom rates', 'myoclonic and absence seizure outcomes']","[{'cui': 'C0014553', 'cui_str': 'Absence seizure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270850', 'cui_str': 'Idiopathic generalized epilepsy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2698764', 'cui_str': 'perampanel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0014553', 'cui_str': 'Absence seizure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.383148,"In this post hoc analysis, adjunctive perampanel was not associated with any overall worsening of absence seizures.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Bethel Epilepsy Centre, Maraweg 21, 33617, Bielefeld, Germany. Electronic address: Christian.Brandt@mara.de.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Wechsler', 'Affiliation': 'Idaho Comprehensive Epilepsy Center, 1499 West Hays St., Boise, ID, 83702, USA. Electronic address: rtw@idahoepilepsy.com.'}, {'ForeName': 'Terence J', 'Initials': 'TJ', 'LastName': ""O'Brien"", 'Affiliation': 'The Department of Neuroscience, The Central Clinical School, Monash University, The Alfred Centre, 99 Commercial Road, Melbourne, VIC, 3004, Australia; The Departments of Medicine, The Royal Melbourne Hospital, The University of Melbourne, Grattan St., Parkville, VIC, 3010, Australia. Electronic address: terence.obrien@monash.edu.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Patten', 'Affiliation': 'Eisai Ltd., Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, UK. Electronic address: Anna_Patten@eisai.net.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Malhotra', 'Affiliation': 'Eisai Inc., 100 Tice Blvd, Woodcliff Lake, NJ, 07677, USA. Electronic address: Manoj_Malhotra@eisai.com.'}, {'ForeName': 'Leock Y', 'Initials': 'LY', 'LastName': 'Ngo', 'Affiliation': 'Eisai Inc., 100 Tice Blvd, Woodcliff Lake, NJ, 07677, USA. Electronic address: Stella_Ngo@eisai.com.'}, {'ForeName': 'Bernhard J', 'Initials': 'BJ', 'LastName': 'Steinhoff', 'Affiliation': 'Kork Epilepsy Centre, Landstraße 1, 77694, Kehl-Kork, Germany. Electronic address: BSteinhoff@epilepsiezentrum.de.'}]",Seizure,['10.1016/j.seizure.2020.06.011']
1103,32563173,Impact of childhood adversity on network reconfiguration dynamics during working memory in hypogonadal women.,"Many women with no history of cognitive difficulties experience executive dysfunction during menopause. Significant adversity during childhood negatively impacts executive function into adulthood and may be an indicator of women at risk of a mid-life cognitive decline. Previous studies have indicated that alterations in functional network connectivity underlie these negative effects of childhood adversity. There is growing evidence that functional brain networks are not static during executive tasks; instead, such networks reconfigure over time. Optimal dynamics are necessary for efficient executive function; while too little reconfiguration is insufficient for peak performance, too much reconfiguration (supra-optimal reconfiguration) is also maladaptive and associated with poorer performance. Here we examined the impact of adverse childhood experiences (ACEs) on network flexibility, a measure of dynamic reconfiguration, during a letter n-back task within three networks that support executive function: frontoparietal, salience, and default mode networks. Several animal and human subject studies have suggested that childhood adversity exerts lasting effects on executive function via serotonergic mechanisms. Tryptophan depletion (TD) was used to examine whether serotonin function drives ACE effects on network flexibility. We hypothesized that ACE would be associated with higher flexibility (supra-optimal flexibility) and that TD would further increase this measure. Forty women underwent functional imaging at two time points in this double-blind, placebo controlled, crossover study. Participants also completed the Penn Conditional Exclusion Test, a task assessing abstraction and mental flexibility. The effects of ACE and TD were evaluated using generalized estimating equations. ACE was associated with higher flexibility across networks (frontoparietal β = 0.00748, D = 2.79, p = 0.005; salience β = 0.00679, D = 3.02, p = 0.003; and default mode β = 0.00910, D = 3.53, p = 0.0004). While there was no interaction between ACE and TD, active TD increased network flexibility in both ACE groups in comparison to sham depletion (frontoparietal β = 0.00489, D = 2.15, p = 0.03; salience β = 0.00393, D = 1.91, p = 0.06; default mode β = 0.00334, D = 1.73, p = 0.08). These results suggest that childhood adversity has lasting impacts on dynamic reconfiguration of functional brain networks supporting executive function and that decreasing serotonin levels may exacerbate these effects.",2020,"While there was no interaction between ACE and TD, active TD increased network flexibility in both ACE groups in comparison to sham depletion (frontoparietal β = 0.00489, D =","['Forty women underwent', 'hypogonadal women', 'Many women with no history of cognitive difficulties experience executive dysfunction during menopause']","['ACE', 'Tryptophan depletion (TD', 'functional imaging', 'placebo']","['ACE and TD, active TD increased network flexibility']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C2748208', 'cui_str': 'Executive dysfunction'}, {'cui': 'C0587112', 'cui_str': 'During menopause'}]","[{'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",40.0,0.0712399,"While there was no interaction between ACE and TD, active TD increased network flexibility in both ACE groups in comparison to sham depletion (frontoparietal β = 0.00489, D =","[{'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Shanmugan', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA; Penn PROMOTES Research on Sex and Gender in Health, University of Pennsylvania, Philadelphia, PA, USA. Electronic address: sheilashanmugan@gmail.com.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Cao', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Theodore D', 'Initials': 'TD', 'LastName': 'Satterthwaite', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Mary D', 'Initials': 'MD', 'LastName': 'Sammel', 'Affiliation': 'Penn PROMOTES Research on Sex and Gender in Health, University of Pennsylvania, Philadelphia, PA, USA; Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA; Obstetrics and Gynecology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Arian', 'Initials': 'A', 'LastName': 'Ashourvan', 'Affiliation': 'Department of Bioengineering, University of Pennsylvania, Philadelphia, PA, USA; Department of Neurology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Danielle S', 'Initials': 'DS', 'LastName': 'Bassett', 'Affiliation': 'Department of Bioengineering, University of Pennsylvania, Philadelphia, PA, USA; Department of Neurology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA; Department of Physics & Astronomy, University of Pennsylvania, Philadelphia, PA, USA; Department of Electrical & Systems Engineering, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Kosha', 'Initials': 'K', 'LastName': 'Ruparel', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ruben C', 'Initials': 'RC', 'LastName': 'Gur', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'C Neill', 'Initials': 'CN', 'LastName': 'Epperson', 'Affiliation': 'Department of Psychiatry, Anschutz Medical Campus, University of Colorado, Aurora, CO USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Loughead', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104710']
1104,32567679,Fitness and strength responses to distinct exercise modes in twins: Studies of Twin Responses to Understand Exercise as a THerapy (STRUETH) study.,"KEY POINTS


Exercise is considered medicine; however, the individual degree of responsiveness to a standardized dose of exercise is idiosyncratic. Individual responsiveness between distinct exercise modalities and the genetic/environmental contributions to exercise response are not well understood. In this novel randomized cross-over design study, monozygotic and dizygotic twins, as pairs, underwent 3 months of resistance and endurance training, separated by a 3 month washout period, aiming to assess training responses in strength and fitness outcomes to dichotomous training modalities, as well as the genetic/environmental contributions to exercise response. Our findings indicate that (i) individual responsiveness differs between exercise modalities; (ii) low-responders to one mode may be 'rescued' by switching to an alternate mode of exercise; and (iii) genes may not play as large a role, as previously estimated from cross-sectional data, for exercise training adaptation. The present study has implications for those charged with optimizing the benefits of exercise by means of individualizing the exercise prescription.
ABSTRACT


Exercise response is idiosyncratic, although the degree of responsiveness, concordance in response between modalities and genetic contribution to responsiveness are not well understood. We investigated this using a novel randomized cross-over design of dichotomous exercise interventions in mono-(MZ) and di-zygotic (DZ) twin pairs. We studied strength (1RM) and fitness (    V   ̇   O   2   max      ) responses in 84 same-sex untrained twins (30 MZ, 12 DZ pairs; 24.9 ± 5.4 years). Twins, as pairs, underwent 3 months of resistance (RES) and endurance (END) training, separated by a 3 month washout period. Training responses and genetic/environmental contributions to responses were assessed. Leg strength 1RM increased following RES but not END (△47 ± 29 vs. 3 ± 26 kg; P < 0.001), whereas    V   ̇   O   2   max      increased following END but not RES (△0.25 ± 0.26 vs. 0.04 ± 0.25 L min -1  ; P < 0.001). A higher percentage of individuals responded to RES for strength and to END for    V   ̇   O   2   max      (P < 0.0001). Within-individual responses to each mode were not correlated (P > 0.05). Cross-sectional intraclass correlations were higher for MZ than DZ pairs for all variables, largely as a result of shared environment. Following training, MZ, but not DZ pairs, were significantly correlated for strength change to RES (r MZ   = 0.62, P = 0.002) and END (r MZ   = 0.36, P = 0.04), and for    V   ̇   O   2   max      change to END (L min -1  , r MZ   = 0.45, P = 0.02) with a mixture of unshared/shared environmental contributions. Our findings indicate that individual responsiveness differs between modalities and low-responders to one mode may be 'rescued' by switching to an alternate mode. Additionally, genes may not play as large a role as previously estimated from cross-sectional data for training adaptation, and/or cross-sectional data do not reflect longitudinal training effects. The present study has implications for optimizing the individualization of exercise prescription.",2020,A higher percentage of individuals responded to RES for strength and to END for VO 2  max (P < 0.0001).,"['84 same-sex untrained twins (30MZ, 12DZ pairs; 24.9\xa0±\xa05.4\xa0yr', 'mono-(MZ) and di-zygotic (DZ) twin pairs', 'monozygotic and dizygotic twins, as pairs, underwent 3 months of resistance and endurance training', 'twins']","['495·In', 'dichotomous exercise interventions']","['Leg strength 1RM', 'resistance (RES) and endurance (END) training', 'strength change to RES', 'strength (1RM) and fitness (VO 2  max) responses']","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0041429', 'cui_str': 'Fraternal twin'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",,0.0319865,A higher percentage of individuals responded to RES for strength and to END for VO 2  max (P < 0.0001).,"[{'ForeName': 'Channa E', 'Initials': 'CE', 'LastName': 'Marsh', 'Affiliation': 'School of Human Sciences, Exercise and Sport Science, The University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Hannah J', 'Initials': 'HJ', 'LastName': 'Thomas', 'Affiliation': 'School of Human Sciences, Exercise and Sport Science, The University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Louise H', 'Initials': 'LH', 'LastName': 'Naylor', 'Affiliation': 'School of Human Sciences, Exercise and Sport Science, The University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Katrina J', 'Initials': 'KJ', 'LastName': 'Scurrah', 'Affiliation': 'Twins Research Australia, Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'School of Human Sciences, Exercise and Sport Science, The University of Western Australia, Perth, WA, Australia.'}]",The Journal of physiology,['10.1113/JP280048']
1105,32563787,Tolerability and effectiveness of povidone-iodine or mupirocin versus saline sinus irrigations for chronic rhinosinusitis.,"OBJECTIVES


The role of topical anti-infectives in acute exacerbations of chronic rhinosinusitis is controversial. Povidone-iodine is an anti-bacterial and anti-viral that is affordable and available over-the-counter and may demonstrate advantages over mupirocin as a sinus irrigation therapy. The objective was to compare povidone-iodine or mupirocin versus saline sinus irrigations for sinusitis exacerbations in post-surgery subjects as well as to assess tolerability of povidone-iodine sinus irrigations.
MATERIALS AND METHODS


This was a prospective single-blinded (clinician only) randomized controlled trial. Subjects were post-surgery with acute exacerbations of chronic rhinosinusitis and gram-positive bacteria on culture. They received povidone-iodine, mupirocin, or saline sinus irrigations, twice daily for 30 days. Outcomes were post-treatment culture negativity (primary) and Sinonasal Outcome Test-20 and Lund-Kennedy endoscopic score change (secondary).
RESULTS


Of the 62 subjects analyzed, post-treatment culture negativity rate was higher in the MUP (14/20, 70%) group compared to the PI (9/21, 43%) and SAL (9/19, 47%) groups, although this was not significant (p = 0.29). Povidone-iodine sinus irrigations at the 1% concentration were very well-tolerated, similar to saline irrigations. There were no significant differences in Sinonasal Outcome Test-20 score (povidone-iodine -0.3 [-0.6, 0.05] vs. mupirocin -0.3 [-0.7, 0.05] vs. saline -0.4 [-0.8, 0.05]; p = 0.86) or Lund-Kennedy endoscopic score (povidone-iodine -3.5 [-7, -0.5] vs. mupirocin -2 [-4, 2] vs. saline -3 [-5, 0]; p = 0.45) change. No serious adverse effects were reported.
CONCLUSIONS


In patients who have had prior sinus surgery with acute exacerbations of CRS and gram-positive bacteria on culture, mupirocin sinus irrigations achieved a better post-treatment culture ""control"" rate compared to saline and povidone-iodine. In addition, 1% povidone-iodine solution was well-tolerated as a sinus irrigation and may represent a feasible method for temporarily disinfecting the sinonasal cavity of bacteria and viruses such as COVID-19.",2020,"There were no significant differences in Sinonasal Outcome Test-20 score (povidone-iodine -0.3 [-0.6, 0.05] vs. mupirocin -0.3","['patients who have had prior sinus surgery with acute exacerbations of CRS and gram-positive bacteria on culture, mupirocin sinus irrigations', 'sinusitis exacerbations in post-surgery subjects', 'chronic rhinosinusitis', '62 subjects analyzed', 'Subjects were post-surgery with acute exacerbations of chronic rhinosinusitis and gram-positive bacteria on culture']","['povidone-iodine, mupirocin, or saline sinus irrigations', 'Povidone-iodine sinus irrigations', 'saline -3', 'povidone-iodine solution', 'saline and povidone-iodine', 'Povidone-iodine', 'povidone-iodine or mupirocin versus saline sinus irrigations', 'topical anti-infectives']","['Lund-Kennedy endoscopic score', 'Tolerability and effectiveness', 'Sinonasal Outcome Test-20 score', 'culture negativity rate', 'culture negativity (primary) and Sinonasal Outcome Test-20 and Lund-Kennedy endoscopic score change (secondary', 'serious adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018154', 'cui_str': 'Gram-positive bacteria'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0085259', 'cui_str': 'Mupirocin'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0037199', 'cui_str': 'Sinusitis'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0085259', 'cui_str': 'Mupirocin'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C5197691', 'cui_str': 'SNOT-20'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.208361,"There were no significant differences in Sinonasal Outcome Test-20 score (povidone-iodine -0.3 [-0.6, 0.05] vs. mupirocin -0.3","[{'ForeName': 'Victoria S', 'Initials': 'VS', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, University of Washington, Box 356515, Seattle, WA 98195, United States of America. Electronic address: vlee39@uic.edu.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Pottinger', 'Affiliation': 'Department of Medicine, Division of Allergy & Infectious Diseases, University of Washington, 1959 NE Pacific St, PO Box 356130, Courier BB-302, Seattle, WA 98195, United States of America.'}, {'ForeName': 'Greg E', 'Initials': 'GE', 'LastName': 'Davis', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, University of Washington, Box 356515, Seattle, WA 98195, United States of America.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102604']
1106,32526832,"Effects of Particulate Matter Education on Self-Care Knowledge Regarding Air Pollution, Symptom Changes, and Indoor Air Quality among Patients with Chronic Obstructive Pulmonary Disease.","The burden of illness resulting from adverse environmental exposure is significant. Numerous studies have examined self-care behaviors among patients with chronic obstructive pulmonary disease (COPD), but seldom assess these behaviors in relation to air pollution. The study aims to examine the effects of particulate matter (PM) education on prevention and self-care knowledge regarding air pollution, symptom changes, and indoor PM concentration levels among patients with COPD. A longitudinal, quasi-experimental design using a generalized estimating equation examined the effectiveness of the education intervention. Participants were 63 patients with COPD, of whom only 25 received intervention. Levels of PM 2.5  and PM 10  decreased in the first-month follow-up in the experimental group. Improvement of knowledge and prevention regarding PM in the first and third months were also greater in the experimental group compared to the control. Regarding the COPD assessment test and physical domain scores, the experimental group exhibited a greater improvement in the first-month follow-up. Scores on the psychological domain significantly changed in the sixth-month follow-up. The PM education coordinated by nurses improved the health of participants, maintaining six-month effects. Further studies should evaluate the practice barriers and effects of health education on preventive self-care behaviors regarding indoor PM among patients with COPD.",2020,Improvement of knowledge and prevention regarding PM in the first and third months were also greater in the experimental group compared to the control.,"['Participants were 63 patients with COPD, of whom only 25 received intervention', 'patients with chronic obstructive pulmonary disease (COPD', 'patients with COPD', 'Patients with Chronic Obstructive Pulmonary Disease']","['Particulate Matter Education', 'particulate matter (PM) education']","['psychological domain', 'Self-Care Knowledge Regarding Air Pollution, Symptom Changes, and Indoor Air Quality', 'COPD assessment test and physical domain scores', 'prevention and self-care knowledge regarding air pollution, symptom changes, and indoor PM concentration levels', 'Levels of PM 2.5  and PM 10']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0085760', 'cui_str': 'Indoor Air Quality'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3844011', 'cui_str': '2.5'}]",63.0,0.0204067,Improvement of knowledge and prevention regarding PM in the first and third months were also greater in the experimental group compared to the control.,"[{'ForeName': 'Su-Er', 'Initials': 'SE', 'LastName': 'Guo', 'Affiliation': 'Department of Nursing and Graduate Institute of Nursing, College of Nursing, Chang Gung University of Science and Technology (CGUST), Chiayi County 613016, Taiwan.'}, {'ForeName': 'Miao-Ching', 'Initials': 'MC', 'LastName': 'Chi', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Chang Gung Memorial Hospital, Chiayi County 613016, Taiwan.'}, {'ForeName': 'Su-Lun', 'Initials': 'SL', 'LastName': 'Hwang', 'Affiliation': 'Department of Nursing and Graduate Institute of Nursing, College of Nursing, Chang Gung University of Science and Technology (CGUST), Chiayi County 613016, Taiwan.'}, {'ForeName': 'Chieh-Mo', 'Initials': 'CM', 'LastName': 'Lin', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Chang Gung Memorial Hospital, Chiayi County 613016, Taiwan.'}, {'ForeName': 'Yu-Ching', 'Initials': 'YC', 'LastName': 'Lin', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Chang Gung Memorial Hospital, Chiayi County 613016, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17114103']
1107,32526849,Therapeutic Atmosphere in Psychotherapy Sessions.,"There is uncertainty concerning what the active ingredients in psychotherapy are. The First Experimental Study of Transference interpretations (FEST) was a randomized controlled trial of the effects of transference work (TW) in psychodynamic psychotherapy. Women with low quality of object relations (QOR) showed a large positive effect of transference work, while men with high QOR showed a slight negative effect. The present study aimed to expand the knowledge from the FEST by investigating the therapeutic atmosphere with Structural Analysis of Social Behavior (SASB). Two-way ANOVAs were conducted to investigate differences between SASB cluster scores between subgroups. The therapeutic atmosphere was characterized by Protect-Trust, Affirm-Disclose and Control-Submit. Multilevel modeling was used to assess the relationship between a therapist variable and outcomes for men and women. Contrary to expectations, no significant differences in therapeutic atmosphere between subgroups (with or without TW in women with low QOR and men with high QOR) were observed using the process measure SASB.",2020,"Contrary to expectations, no significant differences in therapeutic atmosphere between subgroups (with or without TW in women with low QOR and men with high QOR) were observed using the process measure SASB.","['Women with low quality of object relations (QOR', 'women with low QOR and men with high QOR', 'men and women']","['Transference interpretations (FEST', 'transference work (TW']","['therapeutic atmosphere', 'SASB cluster scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205864', 'cui_str': 'Object Relations'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0040678', 'cui_str': 'Transference'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0004178', 'cui_str': 'Atmosphere'}, {'cui': 'C0204514', 'cui_str': 'Structural analysis'}, {'cui': 'C0037397', 'cui_str': 'Social behavior'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0323645,"Contrary to expectations, no significant differences in therapeutic atmosphere between subgroups (with or without TW in women with low QOR and men with high QOR) were observed using the process measure SASB.","[{'ForeName': 'Marte L', 'Initials': 'ML', 'LastName': 'Siegel', 'Affiliation': 'Department of Psychology, University of Oslo, Forskningsveien 3A, 0373 Oslo, Norway.'}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Gullestad Binder', 'Affiliation': 'Department of Psychology, University of Oslo, Forskningsveien 3A, 0373 Oslo, Norway.'}, {'ForeName': 'Hanne Sofie J', 'Initials': 'HSJ', 'LastName': 'Dahl', 'Affiliation': 'Department of Psychology, University of Oslo, Forskningsveien 3A, 0373 Oslo, Norway.'}, {'ForeName': 'Nikolai O', 'Initials': 'NO', 'LastName': 'Czajkowski', 'Affiliation': 'Department of Psychology, University of Oslo, Forskningsveien 3A, 0373 Oslo, Norway.'}, {'ForeName': 'Kenneth L', 'Initials': 'KL', 'LastName': 'Critchfield', 'Affiliation': 'Department of Graduate Psychology, James Madison University, Harrisonburg, VA 22807, USA.'}, {'ForeName': 'Per A', 'Initials': 'PA', 'LastName': 'Høglend', 'Affiliation': 'Division of Mental Health and Addiction, University of Oslo, Kirkeveien 166, 0450 Oslo, Norway.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Ulberg', 'Affiliation': 'Division of Mental Health and Addiction, University of Oslo, Kirkeveien 166, 0450 Oslo, Norway.'}]",International journal of environmental research and public health,['10.3390/ijerph17114105']
1108,32526852,"Prebiotic Therapy with Inulin Associated with Low Protein Diet in Chronic Kidney Disease Patients: Evaluation of Nutritional, Cardiovascular and Psychocognitive Parameters.","A relationship between dysbiotic gut microbiome and chronic kidney disease (CKD) has been recently documented; it contributes to CKD-related complications, including cardiovascular disease. Aim: We tested how a low-protein diet (LPD)-with or without oral inulin supplementation as a prebiotic-modulates some inflammatory, atherosclerosis and endothelial dysfunction indices and nutritional markers, as well as psychocognitive functions in CKD patients. We conducted a prospective, case-control study on CKD patients on conservative therapy, divided in two groups: the intervention group treated with LPD (0.6 g/kg/day) plus inulin (19 g/day) and a control group treated with LPD without inulin, for six consecutive months. Clinical and hematochemical parameters as well as instrumental, and psychocognitive assessments (by SF-36 survey and MMSE, HAM-D, BDI-II) were recorded in all the participants at baseline (T0), at three months (T1) and at six months (T2). A total of 41 patients were enrolled: 18 in the intervention group and 23 in the control group. At T2, in both groups, we observed a significant reduction of serum nitrogen and phosphorus ( p  ≤ 0.01) and serum uric acid ( p  ≤ 0.03), and an improvement in metabolic acidosis (bicarbonates,  p  ≤ 0.01; base excess,  p  ≤ 0.02). Moreover, at T2 the intervention group showed a reduction in serum insulin ( p  = 0.008) and fasting glucose levels ( p  = 0.022), HOMA-IR ( p  = 0.004), as well as lower total serum cholesterol ( p  = 0.012), triglycerides ( p  = 0.016), C-reactive protein ( p  = 0.044) and homocysteine ( p  = 0.044) and higher HDL ( p  < 0.001) with respect to baseline. We also observed a significant amelioration of some quality of life and functional status indices (SF-36 survey) among the intervention group compared to controls, without a significant improvement in the cognitive state (MMSE). On the other hand, an amelioration in mood (by HAM-D and BDI-II) was found in the intervention group and in controls (only by BID-II). In conclusion, LPD in association with oral inulin supplementation improved glycemic and lipid metabolism and ameliorated the systemic inflammatory state, likely reducing cardiovascular risk in CKD patients and this may represent a promising therapeutic option, also improving quality of life and mood.",2020,"Moreover, at T2 the intervention group showed a reduction in serum insulin ( p  = 0.008) and fasting glucose levels ( p  = 0.022), HOMA-IR ( p  = 0.004), as well as lower total serum cholesterol ( p  = 0.012), triglycerides ( p  = 0.016), C-reactive protein ( p  = 0.044) and homocysteine ( p  = 0.044) and higher HDL ( p  < 0.001) with respect to baseline.","['Chronic Kidney Disease Patients', 'chronic kidney disease (CKD', 'CKD patients', '41 patients were enrolled: 18 in the intervention group and 23 in the control group']","['CKD', 'Prebiotic Therapy with Inulin Associated with Low Protein Diet', 'low-protein diet (LPD)-with or without oral inulin supplementation', 'LPD', 'oral inulin supplementation', 'control group treated with LPD without inulin']","['serum nitrogen and phosphorus', 'fasting glucose levels', 'total serum cholesterol', 'triglycerides', 'cardiovascular risk', 'HOMA-IR', 'quality of life and functional status indices (SF-36 survey', 'metabolic acidosis', 'instrumental, and psychocognitive assessments (by SF-36 survey and MMSE, HAM-D, BDI-II', 'cognitive state (MMSE', 'homocysteine', 'reduction in serum insulin', 'serum uric acid', 'C-reactive protein', 'quality of life and mood', 'glycemic and lipid metabolism']","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0242972', 'cui_str': 'Low protein diet'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C1445957', 'cui_str': 'Serum total cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451175', 'cui_str': 'Functional status index'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0220981', 'cui_str': 'Metabolic acidosis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",41.0,0.0147668,"Moreover, at T2 the intervention group showed a reduction in serum insulin ( p  = 0.008) and fasting glucose levels ( p  = 0.022), HOMA-IR ( p  = 0.004), as well as lower total serum cholesterol ( p  = 0.012), triglycerides ( p  = 0.016), C-reactive protein ( p  = 0.044) and homocysteine ( p  = 0.044) and higher HDL ( p  < 0.001) with respect to baseline.","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Lai', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Mazzaferro', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Muscaritoli', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Mastroluca', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Testorio', 'Affiliation': 'Department of Obstetrical-Gynecological Sciences and Urologic Sciences, Unit of Nephrology, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Adolfo', 'Initials': 'A', 'LastName': 'Perrotta', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Ylenia', 'Initials': 'Y', 'LastName': 'Esposito', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Carta', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Campagna', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Di Grado', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Cesarina', 'Initials': 'C', 'LastName': 'Ramaccini', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'De Leo', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Galani', 'Affiliation': 'Department of Clinical and Experimental Sciences, University of Brescia, 25123 Brescia, Italy.'}, {'ForeName': 'Maria Ida', 'Initials': 'MI', 'LastName': 'Amabile', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Molfino', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy.'}]",Toxins,['10.3390/toxins12060381']
1109,32532144,Process Evaluation of a Clustered Randomized Control Trial of a Comprehensive Intervention to Reduce the Risk of Cardiovascular Events in Primary Health Care in Rural China.,"BACKGROUND


Cardiovascular disease (CVD) is a major public health challenge in China. This study aims to understand the processes of implementing a comprehensive intervention to reduce CVD events in areas of drug therapy, lifestyle changes, and adherence support in a clustered randomized controlled trial (cRCT). This trial consisted of 67 clusters spanning over 3 years in Zhejiang Province, China.
METHOD


A qualitative process evaluation was nested within the cRCT conducted in 9 township hospitals with 27 healthcare providers, 18 semi-structured interviews, and 23 observational studies of clinical practices within the intervention arm.
RESULTS


Effective and repeated trainings using an interactive approach were crucial to improve the prescribing behaviour of family doctors and their patient communication skills. However, the awareness of patients remained limited, thus compromising their use of CVD preventive drugs and adoption of healthy lifestyles. Health system factors further constrained providers' and patients' responses to the intervention. Financial barrier was a major concern because of the low coverage of health insurance. Other barriers included limited doctor-patient trust and suboptimal staff motivation.
CONCLUSION


Our study suggests the feasibility of implementing a comprehensive CVD risk reduction strategy in China's rural primary care facilities. However, health system barriers need to be addressed to ensure the success and sustainability of the intervention.",2020,"RESULTS


Effective and repeated trainings using an interactive approach were crucial to improve the prescribing behaviour of family doctors and their patient communication skills.","['9 township hospitals with 27 healthcare providers, 18 semi-structured interviews, and 23 observational studies of clinical practices within the intervention arm', 'Primary Health Care in Rural China', '67 clusters spanning over 3 years in Zhejiang Province, China', ""China's rural primary care facilities""]","['comprehensive intervention', 'Comprehensive Intervention', 'comprehensive CVD risk reduction strategy']","['prescribing behaviour of family doctors and their patient communication skills', 'Risk of Cardiovascular Events']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]","[{'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.0934951,"RESULTS


Effective and repeated trainings using an interactive approach were crucial to improve the prescribing behaviour of family doctors and their patient communication skills.","[{'ForeName': 'Guanyang', 'Initials': 'G', 'LastName': 'Zou', 'Affiliation': 'School of Economics and Management, Guangzhou University of Chinese Medicine, Guangzhou 510006, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of STDs Prevention and Control, Dermatology Hospital, Southern Medical University, Guangzhou 510091, China.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'King', 'Affiliation': 'Nuffield Centre for International Health and Development, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Zhitong', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Division of Clinical Epidemiology &Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON M5T 3M7, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Walley', 'Affiliation': 'Nuffield Centre for International Health and Development, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Gong', 'Affiliation': 'Zhejiang Provincial Centre for Disease Prevention and Control, Hangzhou 310052, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Zhejiang Provincial Centre for Disease Prevention and Control, Hangzhou 310052, China.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Division of Clinical Epidemiology &Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON M5T 3M7, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph17114156']
1110,32540779,Comparison of simple frenotomy with 4-flap Z-frenuloplasty in treatment for ankyloglossia with articulation difficulty: A prospective randomized study.,"OBJECTIVE


To compare the surgical outcomes of simple frenotomy and the 4-flap Z-frenuloplasty according to the articulation test values and tongue-tie classification in patients with ankyloglossia with articulation difficulty.
STUDY DESIGN


prospective randomized study.
SETTING


Tertiary academic center.
SUBJECTS


and methods: Children with ankyloglossia with articulation difficulty were randomly divided into 2 groups for surgical treatment. Patients were evaluated for the tongue-tie classification and articulation test before surgery. Three months after the operation, the frenulum classification and articulation test were re-evaluated to compare the differences in surgical outcome between the two surgical methods.
RESULTS


Out of 37 patients, 19 underwent the 4-flap Z-frenuloplasty and 18, the simple frenotomy. No differences were observed in the baseline characteristics of the patients assigned to both groups. Changes in the tongue-tie classification and improvement in the articulation test results were observed with both the surgical methods. Both surgical groups had significant improvement in the speech articulation test (consonants) but there was no difference in the speech outcomes between the surgical groups.
CONCLUSION


Although there was no significant difference in the surgical outcome between the two surgical methods, ankyloglossia patients showed improvement in a Korean speech articulation test 3 months after undergoing surgery to release the lingual frenulum.",2020,"Both surgical groups had significant improvement in the speech articulation test (consonants) but there was no difference in the speech outcomes between the surgical groups.
","['patients with ankyloglossia with articulation difficulty', 'ankyloglossia with articulation difficulty', 'and methods', 'Children with ankyloglossia with articulation difficulty', 'Tertiary academic center', '37 patients, 19 underwent the 4-flap Z-frenuloplasty and 18, the simple frenotomy']","['simple frenotomy and the 4-flap Z-frenuloplasty', 'simple frenotomy with 4-flap Z-frenuloplasty']","['speech articulation test', 'speech outcomes', 'surgical outcome', 'Korean speech articulation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152415', 'cui_str': 'Tongue tie'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0192139', 'cui_str': 'Incision of lingual frenum'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0192139', 'cui_str': 'Incision of lingual frenum'}, {'cui': 'C0038925', 'cui_str': 'Flap'}]","[{'cui': 'C0037819', 'cui_str': 'Speech Articulation Tests'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}]",37.0,0.0322658,"Both surgical groups had significant improvement in the speech articulation test (consonants) but there was no difference in the speech outcomes between the surgical groups.
","[{'ForeName': 'Tae Hoon', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Department of Otorhinolaryngology - Head & Neck Surgery, School of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Young Chan', 'Initials': 'YC', 'LastName': 'Lee', 'Affiliation': 'Department of Otorhinolaryngology - Head & Neck Surgery, School of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Don', 'Initials': 'SD', 'LastName': 'Yoo', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Ah', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Gyu', 'Initials': 'YG', 'LastName': 'Eun', 'Affiliation': 'Department of Otorhinolaryngology - Head & Neck Surgery, School of Medicine, Kyung Hee University, Seoul, Republic of Korea. Electronic address: ygeun@khu.ac.kr.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110146']
1111,32535338,A serious-game for child sexual abuse prevention: An evaluation of orbit.,"BACKGROUND


Greater public and professional awareness of the extent and impact of child sexual abuse (CSA) has prompted the inclusions of prevention initiatives within school curricula. However CSA education is not always soundly grounded in empirical evidence, and evaluations of the impact of programs often inadequate.
OBJECTIVE


This paper reports on a randomized-control trial of an empirically informed serious-game for CSA prevention, for children aged 8-10 years. The study also evaluates the impact on learning of complementary classroom lessons and part completion of the Orbit game.
PARTICIPANTS AND SETTING


The evaluation involved 139 students (female = 78; male = 61) aged 8-10 years (Mage = 9.64, SD = 0.33), from an elementary school in Queensland, Australia.
METHOD


All children were pre-tested and post-tested (at 3 months) for knowledge of abuse prevention using the Children's Knowledge of Abuse Questionnaire-Revised (CKAQ-R-III), and a short form (SF) mapped to the learning objectives of Orbit . Children were assigned to one of three groups; i) play Orbit (n = 50); ii) play Orbit and CSA lessons (n = 55); and iii) control (n = 34).
RESULTS


Children in the Orbit play, and Orbit play and lesson groups, significantly (p < .001) increased their CKAQ SF scores, whereas those in the control group did not. Furthermore, those children who completed all of Orbit significantly (p < .001) increased their post-test CKAQ scores, whereas those who didn't complete the game did not.
CONCLUSIONS


This study shows the strength of a serious-games approach for school CSA prevention whilst reporting how child completion can impact learnings.",2020,"RESULTS


Children in the Orbit play, and Orbit play and lesson groups, significantly (p < .001) increased their CKAQ SF scores, whereas those in the control group did not.","['child sexual abuse (CSA', 'child sexual abuse prevention', ""All children were pre-tested and post-tested (at 3 months) for knowledge of abuse prevention using the Children's Knowledge of Abuse Questionnaire-Revised (CKAQ-R-III), and a short form (SF) mapped to the learning objectives of Orbit "", 'The evaluation involved 139 students (female\u202f=\u202f78; male\u202f=\u202f61) aged 8-10 years (Mage\u202f=\u202f9.64, SD\u202f=\u202f0.33), from an elementary school in Queensland, Australia', 'children aged 8-10 years']",['play Orbit (n\u202f=\u202f50); ii) play Orbit and CSA lessons (n\u202f=\u202f55); and iii) control'],"['post-test CKAQ scores', 'CKAQ SF scores']","[{'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1261558', 'cui_str': 'Abuse prevention'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0029180', 'cui_str': 'Orbital cavity'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517449', 'cui_str': '0.33'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0029180', 'cui_str': 'Orbital cavity'}, {'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",139.0,0.0282223,"RESULTS


Children in the Orbit play, and Orbit play and lesson groups, significantly (p < .001) increased their CKAQ SF scores, whereas those in the control group did not.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Queensland, Australia. Electronic address: cmjones@usc.edu.au.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Scholes', 'Affiliation': 'Institute for Learning Sciences & Teacher Education, Australian Catholic University, Queensland, Australia. Electronic address: laura.scholes@acu.edu.au.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Rolfe', 'Affiliation': 'Ecoludology Games, Queensland, Australia. Electronic address: ben@ecoludology.com.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Stieler-Hunt', 'Affiliation': 'School of Creative Industries, University of the Sunshine Coast, Queensland, Australia. Electronic address: cstieler@usc.edu.au.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104569']
1112,32682996,THR1VE! Positive psychology intervention to treat diabetes distress in teens with type 1 diabetes: Rationale and trial design.,"Adolescents with type 1 diabetes (T1D) experience high rates of diabetes distress, which negatively influence self-management and glycemic control. Building on effective positive psychology interventions to improve adherence in adults, as well as our pilot work to adapt these interventions for adolescents, we developed a positive psychology intervention for adolescents with T1D. The goal of THR1VE! is to reduce diabetes distress in adolescents with T1D and improve their diabetes outcomes. This multi-site randomized controlled trial compares a Diabetes Education + text-message-based Positive Affect intervention, to a Diabetes Education control condition. In the ongoing trial, we are evaluating the effects of the intervention on adolescents' diabetes distress, self-management, and glycemic control. This paper describes the rationale, trial design, and methodology of the THR1VE! Study.",2020,"Adolescents with type 1 diabetes (T1D) experience high rates of diabetes distress, which negatively influence self-management and glycemic control.","['Adolescents with type 1 diabetes (T1D) experience high rates of diabetes distress', 'teens with type 1 diabetes', 'adolescents with T1D']","['Diabetes Education + text-message-based Positive Affect intervention', 'Positive psychology intervention']","[""adolescents' diabetes distress, self-management, and glycemic control"", 'diabetes distress']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0417244,"Adolescents with type 1 diabetes (T1D) experience high rates of diabetes distress, which negatively influence self-management and glycemic control.","[{'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Jaser', 'Affiliation': 'Vanderbilt University Medical Center, USA. Electronic address: sarah.jaser@vumc.org.'}, {'ForeName': 'Karishma', 'Initials': 'K', 'LastName': 'Datye', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Morrow', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Sinisterra', 'Affiliation': ""Children's National Hospital, USA.""}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'LeStourgeon', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Fayo', 'Initials': 'F', 'LastName': 'Abadula', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Grace E', 'Initials': 'GE', 'LastName': 'Bell', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Streisand', 'Affiliation': ""Children's National Hospital, USA.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106086']
1113,32549196,Efficacy and Safety of Botulinum Toxin Type A on Persistent Myofascial Pain: A Randomized Clinical Trial.,"This study assessed the safety and efficacy of three different doses of BoNT-A for persistent myofascial pain (MFP). One hundred female subjects were randomly assigned into five groups ( n  = 20): oral appliance (OA), saline solution (SS) and three BoNT-A groups with different doses. Pain intensity and pressure pain threshold were evaluated up to 24 weeks after treatment. Adverse effects related to muscle contraction, masticatory performance, muscle thickness and mandibular bone volume were also assessed. Changes over time were compared within and between groups. The ""nparLD"" package and Wilcoxon signed-rank test were used to analyze the data. BoNT-A reduced pain intensity ( p  < 0.0001) and increased pressure pain threshold ( p  < 0.0001) for up to 24 weeks compared to the placebo. No differences were found between BoNT-A and OA at the last follow-up. A transient decline in masticatory performance ( p  < 0.05) and muscle contraction ( p  < 0.0001), and a decrease in muscle thickness ( p  < 0.05) and coronoid and condylar process bone volume ( p  < 0.05) were found as dose-related adverse effects of BoNT-A. Regardless of the dose, BoNT-A was as effective as OA on MFP. Notwithstanding, due to BoNT-A dose-related adverse effects, we suggest the use of low doses of BoNT-A in MFP patients that do not benefit from conservative treatments.",2020,A reduced pain intensity ( p  < 0.0001) and increased pressure pain threshold ( p  < 0.0001) for up to 24 weeks compared to the placebo.,"['Persistent Myofascial Pain', 'persistent myofascial pain (MFP', 'One hundred female subjects']","['placebo', 'Botulinum Toxin Type A', 'oral appliance (OA), saline solution (SS']","['Efficacy and Safety', 'masticatory performance', 'muscle contraction', 'pain intensity', 'pressure pain threshold', 'safety and efficacy', 'muscle thickness', 'coronoid and condylar process bone volume', 'Pain intensity and pressure pain threshold', 'muscle contraction, masticatory performance, muscle thickness and mandibular bone volume']","[{'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0553642', 'cui_str': 'Myofascial pain'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}]",100.0,0.166347,A reduced pain intensity ( p  < 0.0001) and increased pressure pain threshold ( p  < 0.0001) for up to 24 weeks compared to the placebo.,"[{'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'De la Torre Canales', 'Affiliation': 'Department of Prosthodontics and Periodontology, Piracicaba Dental School, University of Campinas, Sao Paulo 13414-903, Brazil.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Alvarez-Pinzon', 'Affiliation': 'Department of Prosthodontics and Periodontology, Piracicaba Dental School, University of Campinas, Sao Paulo 13414-903, Brazil.'}, {'ForeName': 'Victor Ricardo Manuel', 'Initials': 'VRM', 'LastName': 'Muñoz-Lora', 'Affiliation': 'Department of Prosthodontics and Periodontology, Piracicaba Dental School, University of Campinas, Sao Paulo 13414-903, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Vieira Peroni', 'Affiliation': 'Department of Oral Diagnosis, Piracicaba Dental School, University of Campinas, Sao Paulo 13414-903, Brazil.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farias Gomes', 'Affiliation': 'Department of Oral Diagnosis, Piracicaba Dental School, University of Campinas, Sao Paulo 13414-903, Brazil.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Sánchez-Ayala', 'Affiliation': 'Department of Dentistry, State University of Ponta Grossa, Paraná 84030-900, Brazil.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Haiter-Neto', 'Affiliation': 'Department of Oral Diagnosis, Piracicaba Dental School, University of Campinas, Sao Paulo 13414-903, Brazil.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Manfredini', 'Affiliation': 'Department of Dentistry, University of Siena, 53100 Siena, Italy.'}, {'ForeName': 'Célia Marisa', 'Initials': 'CM', 'LastName': 'Rizzatti-Barbosa', 'Affiliation': 'Department of Prosthodontics and Periodontology, Piracicaba Dental School, University of Campinas, Sao Paulo 13414-903, Brazil.'}]",Toxins,['10.3390/toxins12060395']
1114,32553836,Early Weight Gain Forecasts Accelerated Eruption of Deciduous Teeth and Later Overweight Status during the First Year.,"OBJECTIVES


To determine whether early diet and weight gain velocity have independent or interactive effects on deciduous teeth emergence and overweight status during the first year.
STUDY DESIGN


Monthly measures of anthropometry and teeth eruption were collected during a 1-year trial (0.5-12.5 months) on formula-fed infants in which the type of randomized infant formula (cow milk or extensively hydrolyzed protein) diet significantly affected early (0.5-4.5 months) weight gain velocity. Generalized linear mixed models determined whether early diet and weight gain velocity had independent or interactive effects on timing and pattern of teeth eruption. Data from a trial on breastfed infants were used to explore effects of breast milk vs infant formula diets on teeth eruption and overweight status at 10.5 months.
RESULTS


Independent of infant formula diet, velocities of weight gain had direct effects on the age of first deciduous tooth (P < .04) and number of erupted teeth over time (P < .002). Greater velocity of weight gain from 0.5 to 4.5 months caused earlier and more frequent eruption of deciduous teeth from 4.5 to 12.5 months. Exploratory follow-up analyses on the breastfed and formula-fed diet groups found early weight gain velocity (P = .001), but not diet or its interaction, had significant effects. Infants in the upper quartile for weight gain velocity had more primary teeth (P = .002), and a greater proportion of them were overweight (P < .001) at 10.5 months.
CONCLUSIONS


Faster weight gain accretion forecasted accelerated primary teeth eruption and increased percentage of children who were overweight-risk factors for dental caries and obesity.
TRIAL REGISTRATION


ClinicalTrials.govNCT01700205 [2012-2015] and NCT01667549 [2012-2015].",2020,"Exploratory follow-up analyses on the BF and FF diet groups found early weight gain velocity (P=0.001), but not diet or its interaction, had significant effects.",[],"['formula-fed (FF) infants in which the type of randomized infant formula (cow milk or extensively hydrolyzed protein) diet', 'breast milk versus infant formula diets']","['Greater velocity of weight gain', 'frequent eruption of deciduous teeth', 'weight gain velocity', 'teeth eruption and overweight status']",[],"[{'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C0040437', 'cui_str': 'Tooth erupted'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.0416378,"Exploratory follow-up analyses on the BF and FF diet groups found early weight gain velocity (P=0.001), but not diet or its interaction, had significant effects.","[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Mennella', 'Affiliation': 'Monell Chemical Senses Center, Philadelphia, PA. Electronic address: mennella@monell.org.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Reiter', 'Affiliation': 'Monell Chemical Senses Center, Philadelphia, PA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Brewer', 'Affiliation': 'University of Delaware, Newark, DE.'}, {'ForeName': 'Ryan T', 'Initials': 'RT', 'LastName': 'Pohlig', 'Affiliation': 'University of Delaware, Newark, DE.'}, {'ForeName': 'Virginia A', 'Initials': 'VA', 'LastName': 'Stallings', 'Affiliation': ""Children's Hospital of Philadelphia, Division of Gastroenterology, Hepatology and Nutrition, Philadelphia, PA.""}, {'ForeName': 'Jillian C', 'Initials': 'JC', 'LastName': 'Trabulsi', 'Affiliation': 'University of Delaware, Newark, DE.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.06.019']
1115,32495411,Chronic antioxidant administration restores macrovascular function in patients with heart failure with reduced ejection fraction.,"NEW FINDINGS


What is the central question of this study? We aimed to examine oxidative stress, antioxidant capacity and macro- and microvascular function in response to 30 days of oral antioxidant administration in patients with heart failure with reduced ejection fraction. What is the main finding and its importance? We observed an approximately twofold improvement in macrovascular function, assessed via brachial artery flow-mediated dilatation, and a reduction in oxidative stress after antioxidant administration in patients with heart failure with reduced ejection fraction. The improvement in macrovascular function was reversed 1 week after treatment cessation. These findings have identified the potential of oral antioxidant administration to optimize macrovascular health in this patient group.
ABSTRACT


Heart failure with reduced ejection fraction (HFrEF) is characterized by macrovascular dysfunction and elevated oxidative stress that may be mitigated by antioxidant (AOx) administration. In this prospective study, we assessed flow-mediated dilatation (FMD) and reactive hyperaemia responses in 14 healthy, older control participants and 14 patients with HFrEF, followed by 30 days of oral AOx administration (1 g vitamin C, 600 I.U. vitamin E and 0.6 g α-lipoic acid) in the patient group. Blood biomarkers of oxidative stress (malondialdehyde) and AOx capacity (ferric reducing ability of plasma) were also assessed. Patients with HFrEF had a lower %FMD (2.63 ± 1.57%) than control participants (5.62 ± 2.60%), and AOx administration improved %FMD in patients with HFrEF (30 days, 4.90 ± 2.38%), effectively restoring macrovascular function to that of control participants. In a subset of patients, we observed a progressive improvement in %FMD across the treatment period (2.62 ± 1.62, 4.23 ± 2.69, 4.33 ± 2.24 and 4.97 ± 2.56% at days 0, 10, 20 and 30, respectively, n = 12) that was abolished 7 days after treatment cessation (2.99 ± 1.78%, n = 9). No difference in reactive hyperaemia was evident between groups or as a consequence of the AOx treatment. Ferric reducing ability of plasma levels increased (from 6.08 ± 2.80 to 6.70 ± 1.59 mm, day 0 versus 30) and malondialdehyde levels decreased (from 6.81 ± 2.80 to 6.22 ± 2.84 μm, day 0 versus 30) after treatment. These findings demonstrate the efficacy of chronic AOx administration in attenuating oxidative stress, improving AOx capacity and restoring macrovascular function in patients with HFrEF.",2020,Blood biomarkers of oxidative stress (malondialdehyde) and AOx capacity (ferric reducing ability of plasma) were also assessed.,"['14 healthy, older control participants and 14 patients with HFrEF, followed by 30\xa0days of oral AOx administration ', 'patients with HFrEF', 'patients with heart failure with reduced ejection fraction']","['vitamin\xa0E and 0.6\xa0g α-lipoic acid', 'oral antioxidant', 'Chronic antioxidant']","['Ferric reducing ability of plasma levels', 'Blood biomarkers of oxidative stress (malondialdehyde) and AOx capacity (ferric reducing ability of plasma', 'malondialdehyde levels', 'oxidative stress', 'FMD', 'reactive hyperaemia', 'AOx capacity and restoring macrovascular function', 'oxidative stress, antioxidant capacity and macro- and microvascular function', 'macrovascular function', 'macrovascular function, assessed via brachial artery flow-mediated dilatation', 'flow-mediated dilatation (FMD) and reactive hyperaemia responses']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C3848561', 'cui_str': 'ferric cation'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0442436', 'cui_str': 'Via brachial artery'}]",,0.083719,Blood biomarkers of oxidative stress (malondialdehyde) and AOx capacity (ferric reducing ability of plasma) were also assessed.,"[{'ForeName': 'Kanokwan', 'Initials': 'K', 'LastName': 'Bunsawat', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Ratchford', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Jeremy K', 'Initials': 'JK', 'LastName': 'Alpenglow', 'Affiliation': 'Department of Nutrition and Integrative Physiology, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Soung Hun', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Department of Nutrition and Integrative Physiology, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Jarrett', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Stehlik', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Stavros G', 'Initials': 'SG', 'LastName': 'Drakos', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Russell S', 'Initials': 'RS', 'LastName': 'Richardson', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'D Walter', 'Initials': 'DW', 'LastName': 'Wray', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, University of Utah, Salt Lake City, UT, USA.'}]",Experimental physiology,['10.1113/EP088686']
1116,32563863,DHA-enriched fish oil reduces insulin resistance in overweight and obese adults.,"Adipose tissue inflammation is major factor in the development of insulin resistance (IR). Long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFA) docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) are anti-inflammatory bioactive lipids, thus may protect against type 2 diabetes (T2D) development. Previous research has demonstrated a sex-dependent association between LCn-3PUFA and T2D, and evidence suggests LCn-3PUFA may improve IR in a sex-dependent manner. This double-blind, randomized, parallel-arm placebo-controlled study aimed to determine whether DHA-enriched fish oil (FO) supplementation improves IR. Sex-dependent effects were assessed by testing for an interaction between sex and treatment in the multiple regression models. Men and women with abdominal obesity (waist circumference: males, ≥102 cm; females, ≥88 cm) and without diabetes were recruited from the community. Participants (age: 50.9 ± 12.7 years, female: 63.7%, BMI: 32.4 ± 6.6 kg/m 2 ) were randomly allocated to either 2 g FO (860 mg DHA + 120 mg EPA) (intervention, n = 38) or 2 g corn oil (CO) /day (control, n = 35) for 12 weeks in a double-blind randomised controlled trial. A fasting blood sample was collected at 0 and 12 weeks for assessment of IR, glucose and blood lipid profile. Sixty-eight participants completed the intervention. Compared with CO (n = 32), FO (n = 36) significantly reduced fasting insulin by -1.62 μIU/L (95%CI: -2.99, -0.26,) (p = 0.021) and HOMA-IR by -0.40 units (95%CI: -0.78, -0.02, p = 0.038). Higher insulin and HOMA-IR at baseline were associated with greater reductions in the FO group (p < 0.001). There was no interaction between sex and treatment for the change in insulin (p-interaction sex*treatment  = 0.816) or HOMA-IR (p-interaction sex*treatment  = 0.825). DHA-enriched FO reduces IR in adults with abdominal obesity, however, sex-dependent differences were not evident in this study.",2020,Higher insulin and HOMA-IR at baseline were associated with greater reductions in the FO group (p < 0.001).,"['overweight and obese adults', 'Participants (age: 50.9\xa0±\xa012.7 years, female: 63.7%, BMI: 32.4\xa0±\xa06.6\xa0kg/m 2 ', 'adults with abdominal obesity', 'Men and women with abdominal obesity (waist circumference: males, ≥102\xa0cm; females, ≥88\xa0cm) and without diabetes were recruited from the community']","['FO (860\xa0mg DHA\xa0+\xa0120\xa0mg EPA) (intervention, n\xa0=\xa038) or 2\xa0g corn oil (CO', 'μIU/L (95%CI', 'DHA-enriched FO', 'DHA-enriched fish oil (FO) supplementation', 'CO', 'Long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFA) docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA', 'DHA-enriched fish oil', 'placebo']","['HOMA-IR', 'insulin resistance', 'IR, glucose and blood lipid profile', 'Higher insulin and HOMA-IR', 'fasting insulin']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517546', 'cui_str': '12.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517709', 'cui_str': '32.4'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",68.0,0.375942,Higher insulin and HOMA-IR at baseline were associated with greater reductions in the FO group (p < 0.001).,"[{'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Abbott', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Australia; Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Australia.'}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Burrows', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Australia; School of Health Sciences, University of Newcastle, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Acharya', 'Affiliation': 'School of Public Health and Medicine, University of Newcastle, Australia; Department of Endocrinology and Diabetes, John Hunter Hospital, Newcastle, Australia.'}, {'ForeName': 'R N', 'Initials': 'RN', 'LastName': 'Thota', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Australia; Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Australia; Riddet Institute, Massey University, Palmerston North, New Zealand.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Garg', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Australia; Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Australia; Riddet Institute, Massey University, Palmerston North, New Zealand. Electronic address: manohar.garg@newcastle.edu.au.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2020.102154']
1117,32563939,Association of Meteorin-Like Hormone with insulin resistance and body composition in healthy Iranian adults.,"BACKGROUND AND AIMS


Sedentary behavior and/or physical inactivity are modifiable risk factors for noncommunicable diseases. Myokines are one of the mediators of physical activity health benefits. Relationship between regular physical activity (RPA) and baseline plasma Meteorin-Like Hormone (Metrnl) has not been explored in human. Hence, we compared baseline plasma Metrnl between sedentary individuals and ones with recreational physical activities, and role of Metrnl as a biological messenger between physical activity and insulin resistance and body composition was also explored.
METHODS


Forty healthy young men (aged: 21 ± 2.1 yrs; BMI: 23 ± 3.44 kg/m 2 ) completed the study. Participants were equally assigned into two groups of control (sedentary) and case (recreational athletes). Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR) were assessed under resting conditions.
RESULTS


Except for baseline blood glucose, baseline plasma Metrnl, insulin, HOMA-IR and body mass index and body fat percentage were similar between two groups (P > 0.05). However, after Metrnl correction for the degree of insulin resistance index (Metrnl/HOMA-IR), recreational athletes showed a significantly greater baseline compared to sedentary subjects (P < 0.05). Baseline blood glucose showed a negative and significant correlation with baseline plasma Metrnl (P < 0.05).
CONCLUSIONS


Baseline plasma Metrnl is correlated with regular physical activity and insulin sensitivity, but not with body composition parameters. Metrnl may be one possible mediator of the beneficial effects of PA on insulin sensitivity in healthy humans. Hence, increasing awareness of the benefits of physical activity and incorporating physical activity into lifestyle are of great importance for people with non-communicable diseases.",2020,"Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR) were assessed under resting conditions.
","['healthy humans', 'Forty healthy young men (aged: 21\xa0±\xa02.1\xa0yrs', 'people with non-communicable diseases', 'healthy Iranian adults']","['Meteorin-Like Hormone with insulin resistance and body composition', 'regular physical activity (RPA) and baseline plasma Meteorin-Like Hormone (Metrnl']","['Baseline blood glucose', 'degree of insulin resistance index (Metrnl/HOMA-IR', 'baseline plasma Metrnl', 'baseline blood glucose, baseline plasma Metrnl, insulin, HOMA-IR and body mass index and body fat percentage', 'Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4505065', 'cui_str': 'Non-infectious Diseases'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",40.0,0.0269477,"Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR) were assessed under resting conditions.
","[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Alizadeh', 'Affiliation': 'Faculty of Sport Sciences, University of Mazandaran, Babolsar, Mazandaran, Iran. Electronic address: h.alizadeh.aw@gmail.com.'}, {'ForeName': 'Aliakbar', 'Initials': 'A', 'LastName': 'Alizadeh', 'Affiliation': 'Department of Sport Physiology, Faculty of Sport Sciences, Shahid Chamran University of Ahvaz, Ahvaz, Iran. Electronic address: aliakbar.alizadeh1984@gmail.com.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.05.031']
1118,32683489,A brief bout of exercise in hypoxia reduces ventricular filling rate and stroke volume response during muscle metaboreflex activation.,"PURPOSE


The hemodynamic consequences of exercise in hypoxia have not been completely investigated. The present investigation aimed at studying the hemodynamic effects of contemporary normobaric hypoxia and metaboreflex activation.
METHODS


Eleven physically active, healthy males (age 32.7 ± 7.2 years) completed a cardiopulmonary test on an electromagnetically braked cycle-ergometer to determine their maximum workload (W max ). On separate days, participants performed two randomly assigned exercise sessions (3 minutes pedalling at 30% of W max ): (1) one in normoxia (NORMO), and (2) one in normobaric hypoxia with FiO 2  set to 13.5% (HYPO). After each session, the following protocol was randomly assigned: either (1) post-exercise muscle ischemia (PEMI) to study the metaboreflex, or (2) a control exercise recovery session, i.e., without metaboreflex activation. Hemodynamics were assessed with impedance cardiography.
RESULTS


The main result was that the HYPO session impaired the ventricular filling rate (measured as stroke volume/diastolic time) response during PEMI versus control condition in comparison to the NORMO test (31.33 ± 68.03 vs. 81.52 ± 49.23 ml·s -1 ,respectively, p = 0.003). This caused a reduction in the stroke volume response (1.45 ± 9.49 vs. 10.68 ± 8.21 ml, p = 0.020). As a consequence, cardiac output response was impaired during the HYPO test.
CONCLUSIONS


The present investigation suggests that a brief exercise bout in hypoxia is capable of impairing cardiac filling rate as well as stroke volume during the metaboreflex. These results are in good accordance with recent findings showing that among hemodynamic modulators, ventricular filling is the most sensible variable to hypoxic stimuli.",2020,"This caused a reduction in the stroke volume response (1.45 ± 9.49 vs. 10.68 ± 8.21 ml, p = 0.020).","['Eleven physically active, healthy males (age 32.7\u2009±\u20097.2\xa0years) completed a']","['post-exercise muscle ischemia (PEMI) to study the metaboreflex, or (2) a control exercise recovery session, i.e., without metaboreflex activation', 'cardiopulmonary test on an electromagnetically braked cycle-ergometer to determine their maximum workload (W max ', 'exercise sessions (3 minutes pedalling at 30% of W max ): (1) one in normoxia (NORMO), and (2) one in normobaric hypoxia with FiO 2  set to 13.5% (HYPO']","['stroke volume/diastolic time) response', 'cardiac output response', 'ventricular filling rate', 'stroke volume response']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0337108', 'cui_str': 'Brake'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C4517559', 'cui_str': '13.5'}]","[{'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}]",11.0,0.067047,"This caused a reduction in the stroke volume response (1.45 ± 9.49 vs. 10.68 ± 8.21 ml, p = 0.020).","[{'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Mulliri', 'Affiliation': 'Sports Physiology Laboratory, Department of Medical Sciences and Public Health, University of Cagliari, Via Porcell 4, 09124, Cagliari, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Magnani', 'Affiliation': 'Sports Physiology Laboratory, Department of Medical Sciences and Public Health, University of Cagliari, Via Porcell 4, 09124, Cagliari, Italy.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Roberto', 'Affiliation': 'Sports Physiology Laboratory, Department of Medical Sciences and Public Health, University of Cagliari, Via Porcell 4, 09124, Cagliari, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Sechi', 'Affiliation': 'Sports Physiology Laboratory, Department of Medical Sciences and Public Health, University of Cagliari, Via Porcell 4, 09124, Cagliari, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Ghiani', 'Affiliation': 'Sports Physiology Laboratory, Department of Medical Sciences and Public Health, University of Cagliari, Via Porcell 4, 09124, Cagliari, Italy.'}, {'ForeName': 'Gianmarco', 'Initials': 'G', 'LastName': 'Sainas', 'Affiliation': 'Sports Physiology Laboratory, Department of Medical Sciences and Public Health, University of Cagliari, Via Porcell 4, 09124, Cagliari, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Nughedu', 'Affiliation': 'Sports Physiology Laboratory, Department of Medical Sciences and Public Health, University of Cagliari, Via Porcell 4, 09124, Cagliari, Italy.'}, {'ForeName': 'Seyed Alireza', 'Initials': 'SA', 'LastName': 'Hosseini Kakhak', 'Affiliation': 'Faculty of Physical Education and Sport Sciences, Hakim Sabzevari University, Sabzevar, Iran.'}, {'ForeName': 'Pier Paolo', 'Initials': 'PP', 'LastName': 'Bassareo', 'Affiliation': 'University College of Dublin, Mater Misericordiae University Teaching Hospital, Dublin, Ireland.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Crisafulli', 'Affiliation': 'Sports Physiology Laboratory, Department of Medical Sciences and Public Health, University of Cagliari, Via Porcell 4, 09124, Cagliari, Italy. crisafulli@tiscali.it.'}]",European journal of applied physiology,['10.1007/s00421-020-04435-0']
1119,32568845,Anesthesia and Circulating Tumor Cells in Primary Breast Cancer Patients: A Randomized Controlled Trial.,"BACKGROUND


The effect of anesthetic drugs on cancer outcomes remains unclear. This trial aimed to assess postoperative circulating tumor cell counts-an independent prognostic factor for breast cancer-to determine how anesthesia may indirectly affect prognosis. It was hypothesized that patients receiving sevoflurane would have higher postoperative tumor cell counts.
METHODS


The parallel, randomized controlled trial was conducted in two centers in Switzerland. Patients aged 18 to 85 yr without metastases and scheduled for primary breast cancer surgery were eligible. The patients were randomly assigned to either sevoflurane or propofol anesthesia. The patients and outcome assessors were blinded. The primary outcome was circulating tumor cell counts over time, assessed at three time points postoperatively (0, 48, and 72 h) by the CellSearch assay. Secondary outcomes included maximal circulating tumor cells value, positivity (cutoff: at least 1 and at least 5 tumor cells/7.5 ml blood), and the association between natural killer cell activity and tumor cell counts. This trial was registered with ClinicalTrials.gov (NCT02005770).
RESULTS


Between March 2014 and April 2018, 210 participants were enrolled, assigned to sevoflurane (n = 107) or propofol (n = 103) anesthesia, and eventually included in the analysis. Anesthesia type did not affect circulating tumor cell counts over time (median circulating tumor cell count [interquartile range]; for propofol: 1 [0 to 4] at 0 h, 1 [0 to 2] at 48 h, and 0 [0 to 1] at 72 h; and for sevoflurane: 1 [0 to 4] at 0 h, 0 [0 to 2] at 48 h, and 1 [0 to 2] at 72 h; rate ratio, 1.27 [95% CI, 0.95 to 1.71]; P = 0.103) or positivity. In one secondary analysis, administrating sevoflurane led to a significant increase in maximal tumor cell counts postoperatively. There was no association between natural killer cell activity and circulating tumor cell counts.
CONCLUSIONS


In this randomized controlled trial investigating the effect of anesthesia on an independent prognostic factor for breast cancer, there was no difference between sevoflurane and propofol with respect to circulating tumor cell counts over time.",2020,"There was no association between natural killer cell activity and circulating tumor cell counts.
","['nonmetastatic and metastatic breast cancer', 'n = 103) anesthesia, and eventually included in the analysis', 'Between March 2014 and April 2018, 210 participants were enrolled, assigned to', 'n = 107) or', 'Patients aged 18 to 85 yr without metastases and scheduled for primary breast cancer surgery were eligible', 'two centers in Switzerland', 'primary breast cancer patients receiving', 'Primary Breast Cancer Patients']","['sevoflurane anesthesia', 'sevoflurane and propofol', 'sevoflurane or propofol anesthesia', 'sevoflurane', 'propofol']","['natural killer cell activity and tumor cell counts', 'maximal tumor cell counts postoperatively', 'maximal circulating tumor cells value, positivity (cutoff', 'circulating tumor cell counts', 'natural killer cell activity and circulating tumor cell counts', 'postoperative tumor cell counts']","[{'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",210.0,0.167967,"There was no association between natural killer cell activity and circulating tumor cell counts.
","[{'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Hovaguimian', 'Affiliation': 'From the Institute of Anesthesiology, University Hospital of Zurich and University of Zurich, Zurich, Switzerland (F.H., M.S., B.B.-S.) the Epidemiology, Biostatistics and Prevention Institute, Department of Public and Global Health (F.H.) the Epidemiology, Biostatistics and Prevention Institute, Department of Epidemiology (J.B., M.A.P.) the Institute of Physiology and Zurich Center for Integrative Human Physiology (B.R.Z., M.S., B.B.-S.) the Cytometry Facility (C.D., C.E.), University of Zurich, Zurich, Switzerland the Department of Gynecology, University Hospital of Zurich, Zurich, Switzerland (K.J.D., D.F.) the Institute of Anesthesiology, Hirslanden Clinic Zurich, Zurich, Switzerland (U.R., M.S.) the Faculty of Medicine, University of Basel, Basel, Switzerland (M.S.) the Department of Surgery (C.T.) the Clinical Trial Unit (B.P.), Breast Center Zurich, Zurich, Switzerland the Department of Anesthesiology, University of Illinois College of Medicine at Chicago, Chicago, Illinois (B.B.-S.).'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Braun', 'Affiliation': ''}, {'ForeName': 'Birgit Roth', 'Initials': 'BR', 'LastName': ""Z'graggen"", 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schläpfer', 'Affiliation': ''}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Dumrese', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Ewald', 'Affiliation': ''}, {'ForeName': 'Konstantin J', 'Initials': 'KJ', 'LastName': 'Dedes', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fink', 'Affiliation': ''}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Rölli', 'Affiliation': ''}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Seeberger', 'Affiliation': ''}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Tausch', 'Affiliation': ''}, {'ForeName': 'Bärbel', 'Initials': 'B', 'LastName': 'Papassotiropoulos', 'Affiliation': ''}, {'ForeName': 'Milo A', 'Initials': 'MA', 'LastName': 'Puhan', 'Affiliation': ''}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Beck-Schimmer', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003409']
1120,32526688,Examining the effect of a brief psychoeducation intervention based on self-regulation model on sexual satisfaction for women with breast cancer: A randomized controlled trial.,"PURPOSE


The main goal of this study was to investigate whether the Self-Regulation Model could improve sexual satisfaction for women diagnosed with breast cancer.
METHODS


Adult women diagnosed with breast cancer were recruited from a hospital in Qazvin, Iran. Participants were randomly assigned to either an intervention group (n = 40) or a control group (n = 40). All participants were administered a demographic questionnaire and an Index of Sexual Satisfaction (ISS) pre-intervention, immediately post-intervention, and 1, 2, and 3 months following the intervention. The control group completed the assessments along the same time line as the intervention group. Women in the experimental group were provided three sessions of a psychological individual intervention which included psychoeducation regarding their diagnosis and personalized intervention strategies to improve their overall sexual satisfaction with sexual intercourse. Each intervention took between 60 and 90 min to administer.
RESULTS


The experimental and control group participants were well balanced in terms of demographic characteristics and sexual satisfaction scores before the intervention. The intervention group showed a positive increasing trend in the sexual satisfaction scores over time while the control group participants had a negative trend (p < 0.05). There were also statistical differences in the sexual satisfaction scores at each follow-up month (p < 0.05) adjusted for the baseline score and relevant demographical variables, showing longer term effects with a significant increase in sexual satisfaction over time.
CONCLUSION


Providing a psychoeducational based intervention provided an increase of sexual satisfaction during intercourse for women diagnosed with breast cancer. The psychoeducation based intervention provided an opportunity for participants to dispel common myths regarding their disease and obtain new strategies and skills to improve their sexual satisfaction from intercourse with their partners.",2020,"There were also statistical differences in the sexual satisfaction scores at each follow-up month (p < 0.05) adjusted for the baseline score and relevant demographical variables, showing longer term effects with a significant increase in sexual satisfaction over time.
","['women diagnosed with breast cancer', 'Adult women diagnosed with breast cancer were recruited from a hospital in Qazvin, Iran', 'women with breast cancer']","['psychoeducational based intervention', 'Self-Regulation Model', 'psychological individual intervention which included psychoeducation regarding their diagnosis and personalized intervention strategies', 'psychoeducation intervention based on self-regulation model']","['demographic characteristics and sexual satisfaction scores', 'sexual satisfaction scores', 'sexual satisfaction']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0871356', 'cui_str': 'Sexual Gratification'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0482538,"There were also statistical differences in the sexual satisfaction scores at each follow-up month (p < 0.05) adjusted for the baseline score and relevant demographical variables, showing longer term effects with a significant increase in sexual satisfaction over time.
","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Abedini', 'Affiliation': 'Student Research Committee, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Frouzan', 'Initials': 'F', 'LastName': 'Olfati', 'Affiliation': 'Metabolic Diseases Research Center, School of Nursing and Midwifery, Qazvin University of Medical Sciences, Qazvin, Iran. Electronic address: folfati@qums.ac.ir.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Oveisi', 'Affiliation': 'Metabolic Disease Research Center, School of Medicine, Qazvin University of Medical Science, Qazvin, Iran. Electronic address: soveysi@qums.ac.ir.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Bahrami', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran. Electronic address: nbahrami@qums.ac.ir.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Astrologo', 'Affiliation': 'Interpersonal Relationships & Development Laboratory, Centre for Research in Human Development, Department of Psychology, Concordia University, Montréal, QC, Canada. Electronic address: lisa.astrologo@live.ca.'}, {'ForeName': 'Yiong Huak', 'Initials': 'YH', 'LastName': 'Chan', 'Affiliation': 'Biostatistics Unit, Yong Loo Lin School of Medicine, National University Health System, Singapore. Electronic address: yiong_huak_chan@nuhs.edu.sg.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2019.101673']
1121,32527941,Comparing Circulating Tumor Cell Counts with Dynamic Tumor Size Changes as Predictor of Overall Survival: A Quantitative Modeling Framework.,"PURPOSE


Quantitative relationships between treatment-induced changes in tumor size and circulating tumor cell (CTC) counts, and their links to overall survival (OS), are lacking. We present a population modeling framework identifying and quantifying such relationships, based on longitudinal data collected in patients with metastatic colorectal cancer (mCRC) to evaluate the value of tumor size and CTC counts as predictors of OS.
EXPERIMENTAL DESIGN


A pharmacometric approach (i.e., population pharmacodynamic modeling) was used to characterize the changes in tumor size and CTC count and evaluate them as predictors of OS in 451 patients with mCRC treated with chemotherapy and targeted therapy in a prospectively randomized phase III study (CAIRO2).
RESULTS


A tumor size model of tumor quiescence and drug resistance was used to characterize the tumor size time-course, and was, in addition to the total normalized dose (i.e., of all administered drugs) in a given cycle, related to the CTC counts through a negative binomial model (CTC model). Tumor size changes did not contribute additional predictive value when the mean CTC count was a predictor of OS. Treatment reduced the typical mean count from 1.43 to 0.477 (HR = 3.94). The modeling framework was applied to explore whether dose modifications (increased and reduced) would result in a CTC count below 1/7.5 mL after 1 to 2 weeks of treatment.
CONCLUSIONS


Time-varying CTC counts can be useful for early predicting OS in patients with mCRC, and may therefore have potential for model-based treatment individualization. Although tumor size was connected to CTC, its link to OS was weaker.",2020,Treatment reduced the typical mean count from 1.43 to 0.477 (HR= 3.94).,"['patients with mCRC', 'patients with metastatic colorectal cancer (mCRC', '451 patients with mCRC treated with']",['chemotherapy and targeted therapy'],"['tumor size and circulating tumor cell (CTC) counts, and their links to overall survival (OS', 'typical mean count']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",451.0,0.0171847,Treatment reduced the typical mean count from 1.43 to 0.477 (HR= 3.94).,"[{'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Netterberg', 'Affiliation': 'Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Mats O', 'Initials': 'MO', 'LastName': 'Karlsson', 'Affiliation': 'Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Leon W M M', 'Initials': 'LWMM', 'LastName': 'Terstappen', 'Affiliation': 'Department of Medical Cell BioPhysics, Faculty of Science and Technology, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Koopman', 'Affiliation': 'Department of Medical Oncology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Cornelis J A', 'Initials': 'CJA', 'LastName': 'Punt', 'Affiliation': 'Department of Medical Oncology, Amsterdam University Medical Centres, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Lena E', 'Initials': 'LE', 'LastName': 'Friberg', 'Affiliation': 'Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden. lena.friberg@farmbio.uu.se.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-2570']
1122,32531622,Comparison of functional outcomes of cartilage tympanoplasty with silastic sheet versus Gelfoam packing in middle ear.,"BACKGROUND AND AIM


Tympanoplasty is a common surgery in otorhinolaryngology field. In majority of procedures, in addition to the graft used for closure of tympanic membrane, a packing material is essential to be placed in the middle ear cavity. The main goals of packing can be summarized as providing support to the tympanic membrane and ossicular grafts, aeration of middle ear cavity and hemostasis. Several packing materials are currently available for using in middle ear surgeries. Each agent is associated with particular advantages and disadvantages, so choosing the proper packing agent is essential in tympanoplasty surgeries. In this study we aimed to compare two common packing materials (Gelfoam and silastic sheets) in cartilage tympanoplasty surgeries.
METHODS AND MATERIALS


In this block-randomized clinical trial, 78 patients undergoing tympanoplasty in Vali-e-asr hospital in 2017 and 2018 were enrolled. They were randomly assigned to silastic sheet or gelfoam groups. The functional outcomes were compared between the groups. Statistical analysis was performed by SPSS.
RESULTS


Success was achieved in 32 (82.1%) patients and 34 (87.2%) patients in gelfoam and silastic sheets' groups, respectively (p = 0.530). The perforation area percentage was significantly lower (P = 0.007) in Gelfoam group. The other parameters were statistically the same in both groups (P > 0.05).
CONCLUSION


Overall, Gelfoam and silastic sheet methods had similar efficacy in cartilage tympanoplasty. Using each method depends on the preferrence of surgeon and patients' characteristics. Multi-center studies with larger sample sizes are needed for more conclusive results.",2020,The perforation area percentage was significantly lower (P = 0.007) in Gelfoam group.,"['78 patients undergoing tympanoplasty in Vali-e-asr hospital in 2017 and 2018 were enrolled', 'middle ear']","['packing materials (Gelfoam and silastic sheets', 'cartilage tympanoplasty with silastic sheet versus Gelfoam packing', 'silastic sheet or gelfoam']","['Success', 'perforation area percentage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure'}]","[{'cui': 'C1289829', 'cui_str': 'Packing material'}, {'cui': 'C0918040', 'cui_str': 'Gelfoam'}, {'cui': 'C0074517', 'cui_str': 'Silastic'}, {'cui': 'C0439643', 'cui_str': 'Sheets'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}]","[{'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",78.0,0.0554288,The perforation area percentage was significantly lower (P = 0.007) in Gelfoam group.,"[{'ForeName': 'Mahtab Rabbani', 'Initials': 'MR', 'LastName': 'Anari', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir Miratashi', 'Initials': 'AM', 'LastName': 'Yazdi', 'Affiliation': 'Surgery Department, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Kazemi', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atie', 'Initials': 'A', 'LastName': 'Moghtadaie', 'Affiliation': 'Internal Medicine Department, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abolfazl', 'Initials': 'A', 'LastName': 'Farbod', 'Affiliation': 'School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Emami', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: hd_emami@yahoo.com.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102588']
1123,32534250,External trigeminal nerve stimulation for drug resistant epilepsy: A randomized controlled trial.,"BACKGROUND


External trigeminal nerve stimulation (ETNS) is an emergent, non-invasive neurostimulation therapy delivered bilaterally with adhesive skin electrodes. In previous studies, ETNS was associated to a decrease in seizure frequency in patients with focal drug-resistant epilepsy (DRE).
OBJECTIVE


To determine the long-term efficacy and tolerability of ETNS in patients with focal DRE. Moreover, to explore whether its efficacy depends on the epileptogenic zone (frontal or temporal), and its impact on mood, cognitive function, quality of life, and trigeminal nerve excitability.
METHODS


Forty consecutive patients with frontal or temporal DRE, unsuitable for surgery, were randomized to ETNS or usual medical treatment. Participants were evaluated at 3, 6 and 12 months for efficacy, side effects, mood scales, neuropsychological tests and trigeminal nerve excitability.
RESULTS


Subjects had a median of 15 seizures per month and had tried a median of 12.5 antiepileptic drugs. At 12 months, percentage of responders was 50% in ETNS group and 0% in control group. Seizure frequency in ETNS group decreased by -43.5% from baseline. Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively). Median stimulation intensity was 6.2 mA. ETNS improved quality of life, but not anxiety or depression. Long-term ETNS affected neither neuropsychological function, nor trigeminal nerve excitability. No relevant adverse events were observed.
CONCLUSIONS


ETNS is an effective and well-tolerated therapy for focal DRE. Patients with temporal epilepsy showed a better response than those with frontal epilepsy. Future studies with larger populations may define its role compared to other neurostimulation techniques.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that ETNS reduces seizure frequency in patients with focal DRE.",2020,"Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively).","['Patients with temporal epilepsy', 'Subjects had a median of 15 seizures per month and had tried a median of 12.5 antiepileptic drugs', 'patients with focal drug-resistant epilepsy (DRE', 'drug resistant epilepsy', 'Forty consecutive patients with frontal or temporal DRE, unsuitable for surgery', 'patients with focal DRE']","['ETNS or usual medical treatment', 'External trigeminal nerve stimulation (ETNS', 'ETNS', 'External trigeminal nerve stimulation']","['quality of life', 'seizure frequency', 'neuropsychological function, nor trigeminal nerve excitability', 'efficacy, side effects, mood scales, neuropsychological tests and trigeminal nerve excitability', 'Seizure frequency', 'Median stimulation intensity', 'adverse events', 'anxiety or depression', 'mood, cognitive function, quality of life, and trigeminal nerve excitability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C1096063', 'cui_str': 'Refractory epilepsy'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0040996', 'cui_str': 'Trigeminal nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040996', 'cui_str': 'Trigeminal nerve structure'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",40.0,0.130105,"Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively).","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Gil-López', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain. Electronic address: fran.gil.lopez@gmail.com.""}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Boget', 'Affiliation': 'Epilepsy Unit, Department of Neuropsychology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Manzanares', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Donaire', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Conde-Blanco', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Baillés', 'Affiliation': 'Epilepsy Unit, Department of Psychiatry, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Pintor', 'Affiliation': 'Epilepsy Unit, Department of Psychiatry, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Setoaín', 'Affiliation': 'Epilepsy Unit, Department of Nuclear Medicine, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Bargalló', 'Affiliation': 'Epilepsy Unit, Department of Neurorradiology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Navarro', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Casanova', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Valls', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Roldán', 'Affiliation': 'Epilepsy Unit, Department of Neurosurgery, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Rumià', 'Affiliation': 'Epilepsy Unit, Department of Neurosurgery, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Casanovas', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Domenech', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Ferrán', 'Initials': 'F', 'LastName': 'Torres', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Carreño', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}]",Brain stimulation,['10.1016/j.brs.2020.06.005']
1124,32534252,"Two weeks of image-guided left dorsolateral prefrontal cortex repetitive transcranial magnetic stimulation improves smoking cessation: A double-blind, sham-controlled, randomized clinical trial.","BACKGROUND


Previous studies have found that repetitive transcranial magnetic stimulation (rTMS) to the left dorsal lateral prefrontal cortex (LDLPFC) transiently reduces smoking craving, decreases cigarette consumption, and increases abstinence rates.
OBJECTIVE


We investigated whether 10 daily MRI-guided rTMS sessions over two weeks to the LDLPFC paired with craving cues could reduce cigarette consumption and induce smoking cessation.
METHODS


We enrolled 42 treatment-seeking nicotine-dependent smokers (≥10 cigarettes per day) in a randomized, double-blind, sham-controlled trial. Participants received 10 daily sessions over 2 weeks of either active or sham MRI-guided rTMS (10Hz, 3000 pulses each session) to the LDLPFC concurrently with video smoking cues. The primary outcome was a reduction in biochemically confirmed cigarette consumption with a secondary outcome of abstinence on the target quit date. We also recorded cue-induced craving and withdrawal symptoms.
RESULTS


Compared to sham (n = 17), participants receiving active rTMS (n = 21) smoked significantly fewer cigarettes per day during the 2-week treatment (mean [SD], 13.73[9.18] vs. 11.06[9.29], P < .005) and at 1-month follow-up (12.78[9.53] vs. 7.93[7.24], P < .001). Active rTMS participants were also more likely to quit by their target quit rate (23.81%vs. 0%, OR 11.67, 90% CL, 0.96-141.32, x 2  = 4.66, P = .031). Furthermore, rTMS significantly reduced mean craving throughout the treatments and at follow-up (29.93[13.12] vs. 25.01[14.45], P < .001). Interestingly across the active treatment sample, more lateral coil location was associated with more success in quitting (-43.43[0.40] vs. -41.79[2.24], P < .013).
CONCLUSIONS


Daily MRI-guided rTMS to the LDLPFC for 10 days reduces cigarette consumption and cued craving for up to one month and also increases the likelihood of smoking cessation.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02401672.",2020,"Compared to sham (n=17), participants receiving active rTMS (n=21) smoked significantly fewer cigarettes per day during the 2-week treatment (mean [SD], 13.73[9.18] vs. 11.06[9.29], P<.005) and at 1-month follow-up (12.78[9.53] vs. 7.93[7.24], P<.001).",['enrolled 42 treatment-seeking nicotine-dependent smokers (≥10 cigarettes per day'],"['rTMS', 'Image-guided Left Dorsolateral Prefrontal Cortex Repetitive Transcranial Magnetic Stimulation Improves Smoking Cessation', 'active rTMS', 'repetitive transcranial magnetic stimulation (rTMS', 'LDLPFC paired with craving cues', 'active or sham MRI-guided rTMS (10Hz, 3000 pulses each session) to the LDLPFC concurrently with video smoking cues']","['abstinence on the target quit date', 'likelihood of smoking cessation', 'lateral coil location', 'cigarette consumption and cued craving', 'mean craving', 'likely to quit by their target quit rate']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}]",42.0,0.428626,"Compared to sham (n=17), participants receiving active rTMS (n=21) smoked significantly fewer cigarettes per day during the 2-week treatment (mean [SD], 13.73[9.18] vs. 11.06[9.29], P<.005) and at 1-month follow-up (12.78[9.53] vs. 7.93[7.24], P<.001).","[{'ForeName': 'Xingbao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Center for Biomedical Imaging, Medical University of South Carolina, Charleston, SC, 29425, USA. Electronic address: lixi@musc.edu.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Hartwell', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, 29401, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Henderson', 'Affiliation': 'Center for Biomedical Imaging, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Bashar W', 'Initials': 'BW', 'LastName': 'Badran', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, 29401, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'George', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, 29401, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.06.007']
1125,32534376,Fatty acid desaturation in red blood cell membranes of patients with type 2 diabetes is improved by zinc supplementation.,"BACKGROUND/OBJECTIVE


Membrane flexibility can be a determining factor in pathophysiological mechanisms of type 2 diabetes (T2D). As a cofactor of delta-5 desaturase (D5D) and delta-6 desaturase (D6D), and gene expression regulator, zinc may play a role modulating membrane flexibility by increasing membrane polyunsaturated fatty acids (PUFA) abundance. The objective of this study was to evaluate the effect of a 24-month zinc supplementation (30 mg elemental zinc) on membrane fatty acid composition in patients with T2D.
SUBJECTS/METHODS


Sixty patients with T2D were evaluated. Thirty were randomly assigned to the zinc supplemented group and thirty to the placebo group. Fatty acid composition in red blood cell (RBC) membranes was determined by gas chromatography. Expression of gene encoding for D5D (FADS1), and D6D (FADS2) were evaluated in peripheral blood mononuclear cells by real-time polymerase chain reaction.
RESULTS


After 24 months of supplementation, a greater abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA was found (p = 0.001, p = 0.007, p = 0.033, p = 0.048, respectively). The unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index was increased in the zinc supplemented group at month 24 (p = 0.003 and p  = 0.000, respectively). FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
CONCLUSIONS


Supplementation with 30 mg/d elemental zinc during 24 months in patients with T2D had an effect on the composition of RBC membranes increasing PUFA abundance and in turn, improving membrane flexibility. This effect may be mediated by induction of D5D gene expression.",2020,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
","['patients with T2D', 'Sixty patients with T2D were evaluated', 'patients with type 2 diabetes']","['Fatty acid desaturation', 'zinc supplementation (30\u202fmg elemental zinc', 'placebo']","['membrane flexibility', 'Expression of gene encoding for D5D (FADS1), and D6D (FADS2', 'Fatty acid composition in red blood cell (RBC) membranes', 'abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA', 'FADS1 gene', 'unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index', 'membrane fatty acid composition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0057338', 'cui_str': 'delta-5 fatty acid desaturase'}, {'cui': 'C0065017', 'cui_str': 'Linoleoyl-CoA desaturase'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0050877', 'cui_str': 'adrenic acid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1276035', 'cui_str': 'Pena-Shokeir syndrome type I'}, {'cui': 'C0015690', 'cui_str': 'Unsaturated fatty acid'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",60.0,0.126956,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
","[{'ForeName': 'María Catalina', 'Initials': 'MC', 'LastName': 'Hernández', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Rojas', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Carrasco', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Basfi-Fer', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Valenzuela', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Juana', 'Initials': 'J', 'LastName': 'Codoceo', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Inostroza', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ruz', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile. Electronic address: mruz@med.uchile.cl.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126571']
1126,32541171,"Randomized, Double-Blind, Placebo-Controlled Phase Ⅱ Study on the Efficacy and Safety of Vitamin K1 Ointment for Cetuximab or Panitumumab-Induced Acneiform Eruptions-VIKTORIA Study.","PURPOSE


Skin toxicities associated with anti-epidermal growth factor receptor(EGFR)antibodies, have a profound effect on the continuation of treatment. We assessed the efficacy and safety of vitamin K1(VK1)ointment for acneiform eruptions induced by anti-EGFR antibody treatment.
METHODS


The VK1 ointment was applied to one-half of an affected area and placebo ointment was applied to the other half twice a day for 8 weeks, with photography and clinical evaluation being performed every 2 weeks. The primary endpoint was the change of the VK1/placebo ratio for the number of acneiform eruptions counted by an independent dermatologist between the onset and end of the treatment period.
RESULTS


A total of 30 patients were enrolled. The mean VK1/placebo ratio for the number of acneiform eruptions between the onset and end of the treatment period was -0.158±0.680 and 0.146±0.575, respectively, which was not statistically significant(p=0.069). The mean number of acneiform eruptions at each treatment period at the VK1 and placebo application sites was gradually decreased according to the treatment period.
CONCLUSION


VK1 ointment was not effective against acneiform eruptions induced by treatment with cetuximab or panitumumab. Reassessment of the VK1 concentration in the ointment and the endpoint of skin lesions is required before designing further studies.",2020,VK1 ointment was not effective against acneiform eruptions induced by treatment with cetuximab or panitumumab.,['30 patients were enrolled'],"['Vitamin K1 Ointment for Cetuximab or Panitumumab', 'vitamin K1(VK1)ointment', 'VK1 ointment', 'Placebo', 'placebo ointment', 'cetuximab or panitumumab']","['change of the VK1/placebo ratio for the number of acneiform eruptions', 'effective against acneiform eruptions', 'efficacy and safety', 'mean number of acneiform eruptions', 'mean VK1/placebo ratio for the number of acneiform eruptions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0031862', 'cui_str': 'Vitamin K 1'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175167', 'cui_str': 'Acneiform eruption'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",30.0,0.123209,VK1 ointment was not effective against acneiform eruptions induced by treatment with cetuximab or panitumumab.,"[{'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Hashimoto', 'Affiliation': 'Dept. of Pharmacy, National Cancer Center Hospital.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Iwasa', 'Affiliation': ''}, {'ForeName': 'Takako', 'Initials': 'T', 'LastName': 'Yanai-Takahashi', 'Affiliation': ''}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Honma', 'Affiliation': ''}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kato', 'Affiliation': ''}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Hamaguchi', 'Affiliation': ''}, {'ForeName': 'Yasuhide', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': ''}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Shimada', 'Affiliation': ''}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Yamazaki', 'Affiliation': ''}, {'ForeName': 'Yasuhisa', 'Initials': 'Y', 'LastName': 'Kato', 'Affiliation': ''}]",Gan to kagaku ryoho. Cancer & chemotherapy,[]
1127,32542578,Does Organizing Mentor-Mentee Matches into Small Groups Enhance Treatment Effects in a Site-Based Mentoring Program for Adolescents? Results of a Randomized Controlled Trial.,"Formal youth mentoring is an effective intervention strategy for healthy development during adolescence. Modest and varied effects across programs, however, demonstrate a need to identify factors that can reliably improve outcomes for mentored youth. The purpose of this randomized controlled trial was to test the relative impact of embedding mentee-mentor matches in small groups on youth outcomes and to examine whether this effect was mediated by the quality of the program setting and mentoring relationship quality. Participants included 676 adolescents (M age  = 14.21, range = 11-18; 41.6% female) enrolled in Campus Connections, a site-based youth mentoring program. Most measured outcomes in both conditions (i.e., mentoring groups and a control condition in which pairs were not embedded in a group) were significantly better at post-intervention as compared to pre-intervention. The hypothesis that mentoring groups would have stronger impact, however, was not supported. The results imply that organizing mentor-mentee matches in small groups offer no advantage or disadvantage and that youth may be able to garner benefit from both structures.",2020,"The hypothesis that mentoring groups would have stronger impact, however, was not supported.","['Participants included 676 adolescents (M age \u2009=\u200914.21, range\u2009=\u200911-18; 41.6% female) enrolled in Campus Connections, a site-based youth mentoring program', 'healthy development during adolescence']",[],[],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",[],[],676.0,0.0674145,"The hypothesis that mentoring groups would have stronger impact, however, was not supported.","[{'ForeName': 'Shelley A', 'Initials': 'SA', 'LastName': 'Haddock', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA. shelley.haddock@colostate.edu.'}, {'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Weiler', 'Affiliation': 'University of Minnesota, St. Paul, MN, 55108, USA.'}, {'ForeName': 'Hyanghee', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Kimberly L', 'Initials': 'KL', 'LastName': 'Henry', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lucas-Thompson', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Toni S', 'Initials': 'TS', 'LastName': 'Zimmerman', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Krafchick', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Gereon F', 'Initials': 'GF', 'LastName': 'Fredrickson', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Yetz', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Lise M', 'Initials': 'LM', 'LastName': 'Youngblade', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}]",Journal of youth and adolescence,['10.1007/s10964-020-01267-1']
1128,31811378,The effect of different imaging techniques for the visualisation of evidence in court on jury comprehension.,"Evidence presented within a courtroom should be clear so that the members of the jury can understand it. The presentation of distressing images, such as human remains, can have a negative effect on the jury since photographic images may evoke emotional responses. Therefore, it is important to understand how other visual mediums may improve comprehension, bias, or distress individuals. For this study, 91 individuals were randomly assigned one of three visual evidence formats in a mock courtroom exercise. These included photographs, 3D visualisations, or a 3D-printed model. The results show that the use of 3D imaging improves the juror's understanding of technical language used within a courtroom, which in turn better informs the juror's in their decision-making.",2020,"The results show that the use of 3D imaging improves the juror's understanding of technical language used within a courtroom, which in turn better informs the juror's in their decision-making.",['91 individuals'],['mock courtroom exercise'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0562577', 'cui_str': 'Mocking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",[],91.0,0.0432794,"The results show that the use of 3D imaging improves the juror's understanding of technical language used within a courtroom, which in turn better informs the juror's in their decision-making.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Errickson', 'Affiliation': 'Cranfield Forensic Institute, Defence Academy of the United Kingdom, Cranfield University, Shrivenham, SN6 8LA, UK. david.errickson@cranfield.ac.uk.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Fawcett', 'Affiliation': 'Department of Psychology, Manchester Metropolitan University, Manchester, M15 6BH, UK.'}, {'ForeName': 'T J U', 'Initials': 'TJU', 'LastName': 'Thompson', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Borough Road, Middlesbrough, TS1 3BA, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Campbell', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Borough Road, Middlesbrough, TS1 3BA, UK.'}]",International journal of legal medicine,['10.1007/s00414-019-02221-y']
1129,32683063,Pharmacological Dilutional Therapy Using the Vasopressin Antagonist Tolvaptan for Young Patients With Cystinuria: A Pilot Investigation.,"OBJECTIVE


To perform a pilot study of short-term safety, tolerability, and impact on urinary stone risk parameters of the vasopressin V2-receptor antagonist tolvaptan (which increases urinary excretion of free water) among adolescents and young adults with cystinuria.
MATERIALS AND METHODS


We enrolled cystinuria patients age 12-25 years. Subjects were treated for 4 days at low-dose tolvaptan (0.3 mg/kg/day, maximum 30 mg) and 4 days at high dose (0.6 mg/kg/day, maximum 60 mg). Twenty-four-hour urine collections were done at baseline, day 3-4 of the dosing period, day 7-8 of the dosing period, and 3-6 days after washout. Primary outcome was cystine capacity (mg/L, target capacity > 0). Secondary outcomes included other urinary/serum parameters, tolerability, and thirst response.
RESULTS


Two females (17, 23 years) and 2 males (13, 24 years) were enrolled. Cystine capacity respectively went from baseline of -312, -82, -353, and -628 mg/L to 97, 111, 75, and -3 mg/L on high dose (Figure 1). Twenty-four-hour volume went from 1.96, 3.0, 2.1, and 0.91 L to 11.74, 6.5, 9.9, and 2.8 L on high dose (Figure 2). There were no abnormalities in serum electrolytes or liver enzymes. Subjects did experience extreme thirst (9/10 on visual scale), but none discontinued treatment or reduced dose.
CONCLUSION


Dilutional therapy with tolvaptan increased both cystine capacity and urinary volumes. This treatment approach has the potential to reduce recurrence of stones in this population. Further investigation should study longer term effects and safety, and determine optimal dosing to improve tolerability.",2020,There were no abnormalities in serum electrolytes or liver enzymes.,"['adolescents and young adults with cystinuria', '2 females (17, 23 yrs) and 2 males (13, 24 yrs) were enrolled', 'We enrolled cystinuria patients age 12-25 yrs', 'young patients with cystinuria']","['tolvaptan', 'Pharmacological dilutional therapy', 'vasopressin antagonist tolvaptan', 'vasopressin V2-receptor antagonist tolvaptan']","['24-hour volume', 'serum electrolytes or liver enzymes', 'Cystine capacity', 'urinary/serum parameters, tolerability, and thirst response', 'tolerability', 'cystine capacity and urinary volumes', 'cystine capacity (mg/L, target capacity > 0', 'urinary excretion of free water']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0010691', 'cui_str': 'Cystinuria'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3537128', 'cui_str': 'Vasopressin receptor antagonist'}, {'cui': 'C0162829', 'cui_str': 'V2 Receptors'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0587355', 'cui_str': 'Electrolytes measurement, serum'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0010682', 'cui_str': 'Cystine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]",,0.0469341,There were no abnormalities in serum electrolytes or liver enzymes.,"[{'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Nelson', 'Affiliation': ""Department of Urology, Boston Children's Hospital and Harvard Medical School, Boston, MA. Electronic address: caleb.nelson@childrens.harvard.edu.""}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Kurtz', 'Affiliation': ""Department of Urology, Boston Children's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Alyssia', 'Initials': 'A', 'LastName': 'Venna', 'Affiliation': ""Department of Urology, Boston Children's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Bartley G', 'Initials': 'BG', 'LastName': 'Cilento', 'Affiliation': ""Department of Urology, Boston Children's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Baum', 'Affiliation': ""Division of Nephrology, Boston Children's Hospital and Harvard Medical School, Boston, MA.""}]",Urology,['10.1016/j.urology.2020.07.002']
1130,32544161,Usability and acceptability of a two-way texting intervention for post-operative follow-up for voluntary medical male circumcision in Zimbabwe.,"BACKGROUND


Voluntary medical male circumcision (MC) is safe and effective. Nevertheless, MC programs require multiple post-operative visits. In Zimbabwe, a randomized control trial (RCT) found that post-operative two-way texting (2wT) between clients and MC providers instead of in-person reviews reduced provider workload and safeguarded patient safety. A critical component of the RCT assessed usability and acceptability of 2wT among providers and clients. These findings inform scale-up of the 2wT approach to post-operative follow-up.
METHODS


The RCT assigned 362 adult MC clients with cell phones into 2wT; these men responded to 13 automated daily texts supported by interactive texting or in-person follow-up, when needed. A subset of 100 texting clients filled a self-administered usability survey on day 14. 2wT acceptability was ascertained via 2wT response rates. Among 2wT providers, eight key informant interviews focused on 2wT acceptability and usability. Influences of wage and age on response rates and client-reported potential AEs were explored using linear and logistic regression models, respectively.
RESULTS


Clients felt confident, comfortable, satisfied, and well-supported with 2wT-based follow-up; few noted texting challenges or concerns about healing. Clients felt 2wT saved them time and money. Response rates (92%) suggested 2wT acceptability. Both clients and providers felt 2wT was highly usable. Providers noted 2wT saved them time, empowered clients to engage in their healing, and closed gaps in MC service quality. For scale, providers reinforced good post-operative counseling on AEs and texting instructions. Wage and age did not influence text response rates or potential AE texts.
CONCLUSION


Results strongly suggest that 2wT is highly usable and acceptable for providers and patients. Men with concerns solicited provider guidance and reassurance offered via text. Providers noted that men engaged proactively in their healing. 2wT between providers and patients should be expanded for MC and considered for other short-term care contexts. The trial is registered on ClinicalTrials.gov, trial NCT03119337, and was activated on April 18, 2017. https://clinicaltrials.gov/ct2/show/NCT03119337.",2020,"Wage and age did not influence text response rates or potential AE texts.
","['100 texting clients filled a self-administered usability survey on day 14', 'post-operative follow-up for voluntary medical male circumcision in Zimbabwe', '362 adult MC clients with cell phones into 2wT; these men', 'Men with concerns solicited provider guidance and reassurance offered via text']",[],"['Providers noted 2wT saved them time, empowered clients to engage in their healing, and closed gaps in MC service quality', '2wT acceptability and usability', 'Response rates', 'Usability and acceptability', 'Clients felt 2wT saved them time and money']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0043476', 'cui_str': 'Zimbabwe'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1136359', 'cui_str': 'Cellular Phone'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0204558', 'cui_str': 'Group reassurance'}, {'cui': 'C1444648', 'cui_str': 'Offered'}]",[],"[{'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}]",362.0,0.0385762,"Wage and age did not influence text response rates or potential AE texts.
","[{'ForeName': 'Caryl', 'Initials': 'C', 'LastName': 'Feldacker', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Holeman', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Vernon', 'Initials': 'V', 'LastName': 'Murenje', 'Affiliation': 'International Training and Education Center for Health (I-TECH), Harare, Zimbabwe.'}, {'ForeName': 'Sinokuthemba', 'Initials': 'S', 'LastName': 'Xaba', 'Affiliation': 'Ministry of Health and Child Care, Harare, Zimbabwe.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Korir', 'Affiliation': 'Medic Mobile, Nairobi, Kenya.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Wambua', 'Affiliation': 'Medic Mobile, Nairobi, Kenya.'}, {'ForeName': 'Batsirai', 'Initials': 'B', 'LastName': 'Makunike-Chikwinya', 'Affiliation': 'International Training and Education Center for Health (I-TECH), Harare, Zimbabwe.'}, {'ForeName': 'Marrianne', 'Initials': 'M', 'LastName': 'Holec', 'Affiliation': 'International Training and Education Center for Health (I-TECH), Seattle, WA, United States of America.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Barnhart', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Mufuta', 'Initials': 'M', 'LastName': 'Tshimanga', 'Affiliation': 'Zimbabwe Community Health Intervention Project (ZiCHIRE), Harare, Zimbabwe.'}]",PloS one,['10.1371/journal.pone.0233234']
1131,32556354,"Efficacy of radial extracorporeal shock wave therapy compared with botulinum toxin type A injection in treatment of lower extremity spasticity in subjects with cerebral palsy: A randomized, controlled, cross-over study.","OBJECTIVES


To investigate whether botulinum toxin type A (BTX-A) injection is more effective than radial extracorporeal shock wave therapy in reducing plantar flexor muscle spasticity in subjects with cerebral palsy.
METHODS


A total of 68 subjects with cerebral palsy were randomly allocated to BTX-A injection (Group 1) or radial extracorporeal shock wave therapy (Group 2) (first experiment; E1). Outcome was evaluated using the Tardieu V1 and V3 stretches, at 3 weeks, 2 months (M2) and M3 after baseline. At M6 subjects in Group 1 received radial extracorporeal shock wave therapy and subjects in Group 2 received BTX-A injection (second experiment; E2); outcome was evaluated as in E1. Treatment success was defined as improvement in foot dorsiflexion ≥10° when performing the V3 stretch at M2 in both experiments.
RESULTS


In both experiments mean V1 and V3 significantly improved over time. In E1 both treatments resulted in similar treatment success. In E2 fewer subjects treated with BTX-A injection reached the criteria of treatment success than did subjects treated with radial extracorporeal shock wave therapy, which was due to a carry-over effect from E1. No significant complications were observed.
CONCLUSION


BTX-A injection is not superior to radial extracorporeal shock wave therapy in the treatment of plantar flexor muscle spasticity in subjects with cerebral palsy.",2020,BTX-A injection is not superior to radial extracorporeal shock wave therapy in the treatment of plantar flexor muscle spasticity in subjects with cerebral palsy.,"['subjects with cerebral palsy', '68 subjects with cerebral palsy']","['BTX-A injection (Group 1) or radial extracorporeal shock wave therapy', 'radial extracorporeal shock wave therapy', 'botulinum toxin type', 'BTX-A injection', 'botulinum toxin type A (BTX-A) injection']",['plantar flexor muscle spasticity'],"[{'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]","[{'cui': 'C4060200', 'cui_str': 'Botulinum Toxin Type A Injection [Botox]'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}]",68.0,0.0388298,BTX-A injection is not superior to radial extracorporeal shock wave therapy in the treatment of plantar flexor muscle spasticity in subjects with cerebral palsy.,"[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Vidal', 'Affiliation': 'Blanquerna School of Health Science, Ramon Llull University, Barcelona, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Martí-Fàbregas', 'Affiliation': ''}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Canet', 'Affiliation': ''}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Roqué', 'Affiliation': ''}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Morral', 'Affiliation': ''}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Tur', 'Affiliation': ''}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schmitz', 'Affiliation': ''}, {'ForeName': 'Mercè', 'Initials': 'M', 'LastName': 'Sitjà-Rabert', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2703']
1132,32554133,A video-game based cognitive training for breast cancer survivors with cognitive impairment: A prospective randomized pilot trial.,"INTRODUCTION


We investigated whether a web-based cognitive training video game is an effective approach to improve cognitive decline in combination with our standard of care for rehabilitation of breast cancer (BC) patients.
MATERIALS AND METHODS


Self-selected BC patients between 18 and 71 years old complaining of disturbing cognitive impairment were studied. The patients received access to a web-based internet video game and online cognitive assessments (Aquasnap, Cambridge, MyCQ™). The early intervention group (n = 23) had a training program of 6 months of at least three times a week for a minimum of 60 min of game playing per week at home in addition to standard of care rehabilitation. The delayed intervention (n = 23) received standard of care for three months, followed by three months of similar MyCQ training. Outcome measures were the MyCQ (sub)scores and Activity of Daily Life (ADL), mood, subjective cognition and functional cognitive status measured by classic neuropsychological tests.
RESULTS


At baseline the means for CFQ (a measure of self-reported cognitive failure), anxiety, PSQI and self-reflectiveness were beyond normal range in both groups. CFQ improved significantly better in the intervention group (p = 0.029). Combining the evolution over time in the entire population a significant improvement was seen for overall MyCQ score, level of fear, physical and emotional role limitation, and health change (all p < 0.05), but self-reflectivess deteriorated (p < 0.05)). Significant differences in the various MyCQ subtests over time were: improved speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N back 1 and 2 (all p < 0.05).
CONCLUSION


A program of cognitive training improves cognitive functioning over time. ""Aquasnap"" has a beneficial effect on the perception of subjective cognitive functioning (CFQ) but the exact role of video gaming in this process remains uncertain.",2020,"Significant differences in the various MyCQ subtests over time were: improved speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N","['Self-selected BC patients between 18 and 71 years old complaining of disturbing cognitive impairment were studied', 'breast cancer (BC) patients', 'breast cancer survivors with cognitive impairment']","['video-game based cognitive training', 'cognitive training', 'web-based cognitive training video game', 'MyCQ training', 'access to a web-based internet video game and online cognitive assessments (Aquasnap, Cambridge, MyCQ™']","['speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N', 'cognitive failure), anxiety, PSQI and self-reflectiveness', 'cognitive functioning', 'MyCQ (sub)scores and Activity of Daily Life (ADL), mood, subjective cognition and functional cognitive status measured by classic neuropsychological tests', 'overall MyCQ score, level of fear, physical and emotional role limitation, and health change', 'CFQ']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1319227', 'cui_str': 'Level of fear'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0411642,"Significant differences in the various MyCQ subtests over time were: improved speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bellens', 'Affiliation': 'Multidisciplinary Oncologic Center Antwerp (MOCA), Antwerp University Hospital, Edegem, B2650, Belgium; Centre for Oncological Research (CORE), University of Antwerp, Wilrijk, B2610, Belgium.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Roelant', 'Affiliation': 'Clinical Trial Center (CTC), CRC Antwerp, Antwerp University Hospital, University of Antwerp, Edegem, B2650, Belgium; StatUa, Center for Statistics, University of Antwerp, Antwerp, B2000, Belgium.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Sabbe', 'Affiliation': 'Department of Psychiatry, Antwerp University, Wilrijk, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': 'Multidisciplinary Oncologic Center Antwerp (MOCA), Antwerp University Hospital, Edegem, B2650, Belgium; Centre for Oncological Research (CORE), University of Antwerp, Wilrijk, B2610, Belgium.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'van Dam', 'Affiliation': 'Multidisciplinary Oncologic Center Antwerp (MOCA), Antwerp University Hospital, Edegem, B2650, Belgium; Centre for Oncological Research (CORE), University of Antwerp, Wilrijk, B2610, Belgium. Electronic address: peter.vandam@telenet.be.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.06.003']
1133,32554135,The relationship between the tympanostomy tube extrusion time and viscosity.,"OBJECTIVE


The purpose of the study was to assess the correlation between the tympanostomy tube extrusion time and the viscosity of the middle ear fluid.
METHODS


Thirty-three patients who were scheduled for a tympanostomy tube (TT) insertion were included in the study. During the paracentesis procedure, fluid from the middle ear was obtained, and the viscosity was measured with a viscometer. Patients with effusion values below and above the median viscosity value of 439 cP (cP) were assigned to Group 1 and Group 2, respectively. After the surgery, the patients were followed up monthly until the tubes were observed to be extruded.
RESULTS


The analysis of the correlation between the tube extrusion time and the viscosity was statistically insignificant (p > 0.05). The mean tube extrusion time of Group 1 (12.65 ± 4.152 months) was slightly lower than that of Group 2 (13.81 ± 4.43 months); however, the difference was not statistically significant.
CONCLUSION


The tube extrusion time can be longer or shorter and is independent of the effusion viscosity. Further studies are needed to clarify the factors that affect the TT extrusion time.
TRIAL REGISTRATION NUMBER


NCT03848026.",2020,The analysis of the correlation between the tube extrusion time and the viscosity was statistically insignificant (p > 0.05).,"['Patients with effusion values below and above the median viscosity value of 439\xa0cP (cP', 'Thirty-three patients who were scheduled for a tympanostomy tube (TT) insertion were included in the study']",[],"['mean tube extrusion time', 'tube extrusion time and the viscosity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013687', 'cui_str': 'Effusion'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0850121', 'cui_str': 'Tympanic ventilation tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0443213', 'cui_str': 'Extrusion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}]",33.0,0.0301946,The analysis of the correlation between the tube extrusion time and the viscosity was statistically insignificant (p > 0.05).,"[{'ForeName': 'Nazan', 'Initials': 'N', 'LastName': 'Degirmenci', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: ndegirmenci@bezmialem.edu.tr.'}, {'ForeName': 'Selahattin', 'Initials': 'S', 'LastName': 'Tugrul', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: selahattintugrul@yahoo.com.'}, {'ForeName': 'Seda Sezen', 'Initials': 'SS', 'LastName': 'Goktas', 'Affiliation': '75. Yil Boyabat State Hospital, Department of Otorhinolaryngology and Head and Neck Surgery, Sinop, Turkey. Electronic address: sedasezengoktas@gmail.com.'}, {'ForeName': 'Erol', 'Initials': 'E', 'LastName': 'Senturk', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: erolsent@gmail.com.'}, {'ForeName': 'Omer Faruk', 'Initials': 'OF', 'LastName': 'Calim', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: omercalim@yahoo.com.'}, {'ForeName': 'Remzi', 'Initials': 'R', 'LastName': 'Dogan', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: dr.remzidogan@hotmail.com.'}, {'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Yenigun', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: alperyenigun@gmail.com.'}, {'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Ozturan', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: orhanent@yahoo.com.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110140']
1134,32554173,Neuroendocrine biomarkers of prolonged exposure treatment response in military-related PTSD.,"Posttraumatic stress disorder (PTSD) is associated with dysregulation of the neuroendocrine system, including cortisol, allopregnanolone, and pregnanolone. Preliminary evidence from animal models suggests that baseline levels of these biomarkers may predict response to PTSD treatment. We report the change in biomarkers over the course of PTSD treatment. Biomarkers were sampled from individuals participating in (1) a randomized controlled trial comparing a web-version of Prolonged Exposure (Web-PE) therapy to in-person Present-Centered Therapy (PCT) and (2) from individuals participating in a nonrandomized effectiveness study testing PE delivered in-person as part of an intensive outpatient PTSD program. We found that higher cortisol reactivity during script-driven imagery was associated with higher baseline PTSD severity and that baseline allopregnanolone, pregnanolone, and cortisol reactivity were associated with degree of symptom change over the course of intensive outpatient treatment. These findings demonstrate that peripherally assessed biomarkers are associated with PTSD severity and likelihood of successful treatment outcome of PE delivered daily over two weeks. These assessments could be used to determine which patients are likely to respond to treatment and which patients require augmentation to increase the likelihood of optimal response to PTSD treatment.",2020,"Posttraumatic stress disorder (PTSD) is associated with dysregulation of the neuroendocrine system, including cortisol, allopregnanolone, and pregnanolone.","['military-related PTSD', 'Posttraumatic stress disorder (PTSD']","['web-version of Prolonged Exposure (Web-PE) therapy to in-person Present-Centered Therapy (PCT', 'pregnanolone']",['higher cortisol reactivity'],"[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033008', 'cui_str': '3 alpha, 5 beta-Tetrahydroprogesterone'}]","[{'cui': 'C0541847', 'cui_str': 'Cortisol increased'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.0279829,"Posttraumatic stress disorder (PTSD) is associated with dysregulation of the neuroendocrine system, including cortisol, allopregnanolone, and pregnanolone.","[{'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'Atlanta VA Medical Center, 1670 Clairmont Road, Decatur, GA, 30033, USA; Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: sheila.a.m.rauch@emory.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Sripada', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, USA; University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI, 48109, USA. Electronic address: rekaufma@med.umich.edu.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Burton', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: mark.steven.burton@emory.edu.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Michopoulos', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: vmichop@emory.edu.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Kerley', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: kimberly.kerley@emory.edu.'}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Marx', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, 40 Duke Medicine Circle, Durham, NC, 27710, USA; Durham Veterans Administration Medical Center and VA Mid-Atlantic MIRECC, 508 Fulton Street, Durham, NC, 27705, USA. Electronic address: christine.marx@duke.edu.'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Kilts', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, 40 Duke Medicine Circle, Durham, NC, 27710, USA; Durham Veterans Administration Medical Center and VA Mid-Atlantic MIRECC, 508 Fulton Street, Durham, NC, 27705, USA. Electronic address: jason.kilts@duke.edu.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Naylor', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, 40 Duke Medicine Circle, Durham, NC, 27710, USA; Durham Veterans Administration Medical Center and VA Mid-Atlantic MIRECC, 508 Fulton Street, Durham, NC, 27705, USA. Electronic address: jennifer.naylor@duke.edu.'}, {'ForeName': 'Barbara O', 'Initials': 'BO', 'LastName': 'Rothbaum', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: brothba@emory.edu.'}, {'ForeName': 'Carmen P', 'Initials': 'CP', 'LastName': 'McLean', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Health Care System, 795 Willow Rd, Menlo Park, CA, 94025, USA; Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences, 291 Campus Dr., Stanford, CA, 94305, USA. Electronic address: Carmen.McLean4@va.gov.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Emory University School of Medicine, Department of Obstetrics and Gynecology, 101 Woodruff Circle NE, Ste 4217, Atlanta, 30322, USA. Electronic address: alicia.smith@emory.edu.'}, {'ForeName': 'Seth D', 'Initials': 'SD', 'LastName': 'Norrholm', 'Affiliation': 'Atlanta VA Medical Center, 1670 Clairmont Road, Decatur, GA, 30033, USA; Wayne State University, 3901 Chrysler Dr, Detroit, MI, 48201, USA. Electronic address: SNorrholm@wayne.edu.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Jovanovic', 'Affiliation': 'Wayne State University, 3901 Chrysler Dr, Detroit, MI, 48201, USA. Electronic address: tjovanovic@med.wayne.edu.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Liberzon', 'Affiliation': 'Texas A&M University, 8447 Riverside Parkway, Bryan, TX, 77808-3260, USA. Electronic address: liberzon@tamu.edu.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Williamson', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, 40 Duke Medicine Circle, Durham, NC, 27710, USA; Durham Veterans Administration Medical Center and VA Mid-Atlantic MIRECC, 508 Fulton Street, Durham, NC, 27705, USA. Electronic address: douglas.williamson@duke.edu.'}, {'ForeName': 'Col Jeffrey S', 'Initials': 'CJS', 'LastName': 'Yarvis', 'Affiliation': 'Carl R. Darnall Army Medical Center, Department of Behavioral Health, 36065 Santa Fe Ave., Fort Hood, TX, 76544, USA. Electronic address: jeffrey.s.yarvis.mil@mail.mil.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Dondanville', 'Affiliation': 'University of Texas Health Science Center at San Antonio, Department of Psychiatry and Behavioral Sciences, 7703 Floyd Curl Dr., San Antonio, TX, 78229, USA. Electronic address: Dondanville@uthscsa.edu.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'University of Texas Health Science Center at San Antonio, Department of Psychiatry and Behavioral Sciences, 7703 Floyd Curl Dr., San Antonio, TX, 78229, USA. Electronic address: youngs1@uthscsa.edu.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Keane', 'Affiliation': 'VA Boston Healthcare System, National Center for PTSD (116B-2), 150 South Huntington Avenue, Boston, MA, 02130, USA; Boston University School of Medicine, Department of Psychiatry, 720 Harrison Avenue, Room 906, Boston, MA, 02118, USA. Electronic address: Terry.Keane@va.gov.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'University of Texas Health Science Center at San Antonio, Department of Psychiatry and Behavioral Sciences, 7703 Floyd Curl Dr., San Antonio, TX, 78229, USA; South Texas Veterans Health Care System, Research and Development Service, 7400 Merton Minter, San Antonio, TX, 78229, USA; University of Texas at San Antonio, Department of Psychology, One UTSA Circle, San Antonio, TX, 78249, USA. Electronic address: petersona3@uthscsa.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104749']
1135,32444433,"Protocol for a randomised controlled trial of Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS).","INTRODUCTION


Shoulder pain due to irreparable rotator cuff tears can cause substantial disability, but treatment options are limited. A balloon spacer is a relatively simple addition to a standard arthroscopic debridement procedure, but it is costly and there is no current randomised trial evidence to support its use. This trial will evaluate the clinical and cost-effectiveness of a subacromial balloon spacer for individuals undergoing arthroscopic debridement for irreparable rotator cuff tears.New surgical procedures can provide substantial benefit to patients. Good quality randomised controlled trials (RCTs) are needed, but trials in surgery are typically long and expensive, exposing patients to risk and the healthcare system to substantial costs. One way to improve the efficiency of trials is with an adaptive sample size. Such methods are well established in drug trials but have rarely, if ever, been used in surgical trials.
METHODS AND ANALYSIS


Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS) is a participant and assessor blinded, adaptive, multicentre RCT comparing arthroscopic debridement with the InSpace balloon (Stryker, USA) to arthroscopic debridement alone for people with a symptomatic irreparable rotator cuff tear. It uses a group sequential adaptive design where interim analyses are performed using all of the 3, 6 and 12-month data that are available at each time point. A maximum of 221 participants will be randomised (1:1 ratio), this will provide 90% power (at the 5% level) for a 6 point difference in the primary outcome; the Oxford Shoulder Score at 12 months. A substudy will use deltoid-active MRI scans in 56 participants to assess the function of the balloon. Analysis will be on an intention-to-treat basis and reported according to principles established in the Consolidated Standards of Reporting Trials statement.
ETHICS AND DISSEMINATION


NRES number 18/WM/0025. The results will be disseminated via peer-reviewed publications, presentations at conferences, lay summaries and social media.
TRIAL REGISTRATION NUMBER


ISRCTN17825590.",2020,"A balloon spacer is a relatively simple addition to a standard arthroscopic debridement procedure, but it is costly and there is no current randomised trial evidence to support its use.","['56 participants', 'Subacromial spacer for Tears Affecting Rotator cuff Tendons', 'Tears Affecting Rotator cuff Tendons', '221 participants', 'people with a symptomatic irreparable rotator cuff tear', 'individuals undergoing arthroscopic debridement for irreparable rotator cuff tears']","['subacromial balloon spacer', 'arthroscopic debridement with the InSpace balloon (Stryker, USA', 'deltoid-active MRI scans', 'arthroscopic debridement alone', 'Subacromial spacer']",['Oxford Shoulder Score'],"[{'cui': 'C0221874', 'cui_str': 'Spacer'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0221874', 'cui_str': 'Spacer'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C2960740', 'cui_str': 'Oxford shoulder score'}]",221.0,0.251892,"A balloon spacer is a relatively simple addition to a standard arthroscopic debridement procedure, but it is costly and there is no current randomised trial evidence to support its use.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Metcalfe', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK A.Metcalfe@warwick.ac.uk.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Gemperle Mannion', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Parsons', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Parsons', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Fox', 'Affiliation': 'Patient Representative, Durham, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kearney', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Lawrence', 'Affiliation': 'University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Bush', 'Affiliation': 'University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Kerri', 'Initials': 'K', 'LastName': 'McGowan', 'Affiliation': 'University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Iftekhar', 'Initials': 'I', 'LastName': 'Khan', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Hutchinson', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gates', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Stallard', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Drew', 'Affiliation': 'University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}]",BMJ open,['10.1136/bmjopen-2020-036829']
1136,31814522,"The Effectiveness of an Oral Sensorimotor Stimulation Protocol for the Early Achievement of Exclusive Oral Feeding in Premature Infants. A Randomized, Controlled Trial.","Aims:  This study is aimed to investigate the effectiveness of an oral stimulation protocol in preterm infants compared to usual care, to reduce the time for achieving safe full oral feeding. Methods:  47 preterm infants (25- 30 weeks of gestational age) were randomized into two groups. Babies of the EG (n = 24) received a 10-minute oral stimulation protocol while the CG (n = 23) received the standard care. The primary outcome were the days from the initiation of the intervention until the achievement of full oral feeding. Secondary outcomes were: days from the first day the intervention started until achieving a first oral intake of 30% in the first 5 minutes, days from the first day the intervention started until achieving a first oral intake of 100%, and days of hospitalization. A parametric survival model with Gaussian distribution was used. Results:  The EG achieved full oral feeding 8.3 days before the CG (p = 0.013). EG also achieved the first oral intake of 30% in the first five minutes, 6.03 days before (p = 0.019) and of 100%, 5.88 days before (p = 0.040). EG also spent 6.9 days less hospitalized than CG (p = 0.028). Conclusion:  Oral stimulation in preterm infants significantly shortens the time to achieve full oral feeding and reduces the length of hospitalization.",2020,EG also spent 6.9 days less hospitalized than CG (p = 0.028).,"['Premature Infants', 'Babies of the EG (n = 24', 'preterm infants', '47 preterm infants (25- 30 weeks of gestational age']","['Oral Sensorimotor Stimulation Protocol', '10-minute oral stimulation protocol while the CG', 'oral stimulation protocol']","['intervention started until achieving a first oral intake of 100%, and days of hospitalization', 'time to achieve full oral feeding and reduces the length of hospitalization', 'intervention started until achieving a first oral intake', 'achievement of full oral feeding']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}]",47.0,0.0333618,EG also spent 6.9 days less hospitalized than CG (p = 0.028).,"[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Aguilar-Rodríguez', 'Affiliation': 'Rehabilitation Service, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'León-Castro', 'Affiliation': 'Rehabilitation Service, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Álvarez-Cerezo', 'Affiliation': 'Rehabilitation Service, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Aledón-Andújar', 'Affiliation': 'Rehabilitation Service, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Escrig-Fernández', 'Affiliation': 'Division of Neonatology, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Josefina L', 'Initials': 'JL', 'LastName': 'Rodríguez de Dios-Benlloch', 'Affiliation': 'Division of Neonatology, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hervás-Marín', 'Affiliation': 'Data Science, Biostatistics and Bioinformatics, Health Research Institute La Fe, Valencia, Spain.'}, {'ForeName': 'Máximo', 'Initials': 'M', 'LastName': 'Vento-Torres', 'Affiliation': 'Division of Neonatology, University and Polytechnic Hospital La Fe, Valencia, Spain.'}]",Physical & occupational therapy in pediatrics,['10.1080/01942638.2019.1698688']
1137,32682992,Characterizing the analgesic effects of real and imagined acupuncture using functional and structure MRI.,"Acupuncture and imagery interventions for pain management have a long history. The present study comparatively investigated whether acupuncture and video-guided acupuncture imagery treatment (VGAIT, watching a video of acupuncture on the participant's own body while imagining it being applied) could modulate brain regional connectivity to produce analgesic effects. The study also examined whether pre-intervention brain functional and structural features could be used to predict the magnitude of analgesic effects. Twenty-four healthy participants were recruited and received four different interventions (real acupuncture, sham acupuncture, VGAIT, and VGAIT control) in random order using a cross-over design. Pain thresholds and magnetic resonance imaging (MRI) data were collected before and after each intervention. We first compared the modulatory effects of real acupuncture and VGAIT on intra- and inter-regional intrinsic brain connectivity and found that real acupuncture decreased regional homogeneity (ReHo) and functional connectivity (FC) in sensorimotor areas, whereas VGAIT increased ReHo in basal ganglia (BG) (i.e., putamen) and FC between the BG subcortical network and default mode network. The altered ReHo and FC were associated with changes in pain threshold after real acupuncture and VGAIT, respectively. A multimodality fusion approach with pre-intervention ReHo and gray matter volume (GMV) as features was used to explore the brain profiles underlying individual variability of pain threshold changes by real acupuncture and VGAIT. Variability in acupuncture responses was associated with ReHo and GMV in BG, whereas VGAIT responses were associated with ReHo and GMV in the anterior insula. These results suggest that, through different pathways, both real acupuncture and VGAIT can modulate brain systems to produce analgesic effects.",2020,"The altered ReHo and FC were associated with changes in pain threshold after real acupuncture and VGAIT, respectively.",['Twenty-four healthy participants'],"['real acupuncture and VGAIT', 'acupuncture and video-guided acupuncture imagery treatment (VGAIT, watching a video of acupuncture', 'pre-intervention ReHo and grey matter volume (GMV', 'interventions (real acupuncture, sham acupuncture, VGAIT, and VGAIT control', 'Acupuncture and imagery interventions']","['pain threshold', 'Pain thresholds and magnetic resonance imaging (MRI) data', 'regional homogeneity (ReHo) and functional connectivity (FC']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",24.0,0.0799386,"The altered ReHo and FC were associated with changes in pain threshold after real acupuncture and VGAIT, respectively.","[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, United States.'}, {'ForeName': 'Yiheng', 'Initials': 'Y', 'LastName': 'Tu', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, United States.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, United States.'}, {'ForeName': 'Scott P', 'Initials': 'SP', 'LastName': 'Orr', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, United States.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, United States; Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, United States. Electronic address: jkong2@mgh.harvard.edu.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117176']
1138,32540634,"A randomized, double blind, placebo controlled study to evaluate the effects of ashwagandha (Withania somnifera) extract on sleep quality in healthy adults.","OBJECTIVE


Non-restorative sleep (NRS) affects 10% people worldwide, leading to poor sleep quality, as well as physical and cognitive fatigue. This is the first human study in which an extract of ashwagandha (Withania somnifera Dunal L.) was evaluated for effects in improving overall sleep quality in subjects with NRS.
METHODS


In this randomized, double-blind, placebo-controlled trial, 150 healthy subjects scoring high on non-restorative sleep measures were given 120 mg of standardized ashwagandha extract (Shoden®) once daily for six weeks. Subjects were evaluated using the Restorative Sleep Questionnaire-weekly version and World Health Organization Quality of Life-Bref (WHOQOL) scale. Sleep actigraphy was used to measure the onset of sleep latency, sleep efficiency, total sleep time and wake after sleep onset. Safety of the treatment was determined by testing of vitals, hematology, biochemistry and urinalysis.
RESULTS


A total of 144 subjects completed the study, with no dropouts due to adverse events. A 72% increase in self-reported sleep quality was found for the treatment group, compared with 29% in the placebo group (p < 0.001). Based on activity monitoring data, the treatment group showed significant improvement in sleep efficiency (SE) (p < 0.01), total sleep time (p < 0.001) and sleep latency (p < 0.01) and wake after sleep onset (WASO) (p < 0.05) versus placebo after six weeks. In the ashwagandha group quality of life (QOL) scores showed significant improvement in physical (p < 0.001), psychological (p < 0.001), and environment domains (p < 0.01).
CONCLUSIONS


Supplementation with the standardized ashwagandha extract for six weeks improved the overall quality of sleep by significantly improving the NRS condition in healthy subjects. No treatment related adverse events were reported in the study.
TRIAL REGISTRATION


Clinical Trials Registry-India (www.ctri.nic.in). Registration number: CTRI/2017/02/007801.",2020,"Based on activity monitoring data, the treatment group showed significant improvement in sleep efficiency (SE) (p < 0.01), total sleep time (p < 0.001) and sleep latency (p < 0.01) and wake after sleep onset (WASO) (p < 0.05) versus placebo after six weeks.","['subjects with NRS', 'healthy subjects', 'healthy adults', '150 healthy subjects scoring high on non-restorative sleep measures', '144 subjects completed the study, with no dropouts due to adverse events']","['standardized ashwagandha extract (Shoden®', 'ashwagandha (Withania somnifera) extract', 'placebo']","['Sleep actigraphy', 'Restorative Sleep Questionnaire-weekly version and World Health Organization Quality of Life-Bref (WHOQOL) scale', 'total sleep time', 'overall quality of sleep', 'onset of sleep latency, sleep efficiency, total sleep time and wake after sleep onset', 'overall sleep quality', 'sleep latency', 'adverse events', 'quality of life (QOL) scores', 'sleep quality', 'self-reported sleep quality', 'sleep efficiency (SE']","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]","[{'cui': 'C0613707', 'cui_str': 'Ashwagandha'}, {'cui': 'C1061163', 'cui_str': 'Withania somnifera'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",150.0,0.234196,"Based on activity monitoring data, the treatment group showed significant improvement in sleep efficiency (SE) (p < 0.01), total sleep time (p < 0.001) and sleep latency (p < 0.01) and wake after sleep onset (WASO) (p < 0.05) versus placebo after six weeks.","[{'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Deshpande', 'Affiliation': 'International Institute of Sleep Sciences (IISS), NEST Hospital, Second Floor, Behind SBI Naupada Br, Off Gokhale Road, Naupada, Thane, Maharashtra, 400602, India. Electronic address: abhijitd1965@gmail.com.'}, {'ForeName': 'Nushafreen', 'Initials': 'N', 'LastName': 'Irani', 'Affiliation': 'International Institute of Sleep Sciences (IISS), NEST Hospital, Second Floor, Behind SBI Naupada Br, Off Gokhale Road, Naupada, Thane, Maharashtra, 400602, India.'}, {'ForeName': 'Ratna', 'Initials': 'R', 'LastName': 'Balkrishnan', 'Affiliation': 'International Institute of Sleep Sciences (IISS), NEST Hospital, Second Floor, Behind SBI Naupada Br, Off Gokhale Road, Naupada, Thane, Maharashtra, 400602, India.'}, {'ForeName': 'Irin Rosanna', 'Initials': 'IR', 'LastName': 'Benny', 'Affiliation': 'Amala Institute of Medical Sciences, Amala Nagar PO, Thrissur, Kerala, 680555, India.'}]",Sleep medicine,['10.1016/j.sleep.2020.03.012']
1139,32542748,"Prospective, randomized trial of treatment for mild ulnar neuropathy at the elbow.",,2020,,['mild ulnar neuropathy at the elbow'],[],[],"[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0154743', 'cui_str': 'Ulnar neuropathy'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}]",[],[],,0.0211104,,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Podnar', 'Affiliation': 'Institute of Clinical Neurophysiology, Division of Neurology, University Medical Center, Ljubljana, Slovenia.'}]",Muscle & nerve,['10.1002/mus.27005']
1140,32543382,Cost Saving of Short Hospitalization Nonoperative Management for Acute Uncomplicated Appendicitis.,"BACKGROUND


Nonoperative management (NOM) of uncomplicated appendicitis has gained recognition as an alternative to surgery. In the largest published randomized trial (Appendicitis Acuta), patients received a 3-d hospital stay for intravenous antibiotics; however, cost implications for health care systems remain unknown. We hypothesized short stay protocols would be cost saving compared with a long stay protocol.
MATERIALS AND METHODS


We constructed a Markov model comparing the cost of three protocols for NOM of acute uncomplicated appendicitis: (1) long stay (3-d hospitalization), (2) short stay (1-d hospitalization), and (3) emergency department (ED) discharge. The long stay protocol was modeled on data from the APPAC trial. Model variables were abstracted from national database and literature review. One-way and two-way sensitivity analyses were performed to determine the impact of uncertainty on the model.
RESULTS


The long stay treatment protocol had a total 5-y projected cost of $10,735 per patient. The short stay treatment protocol costs $8026 per patient, and the ED discharge protocol costs $6,825, which was $2709 and $3910 less than the long stay protocol, respectively. One-way sensitivity analysis demonstrated that the relative risk of treatment failure with the short stay protocol needed to exceed 6.3 (absolute risk increase of 31%) and with the ED discharge protocol needed to exceed 8.75 (absolute risk increase of 45%) in order for the long stay protocol to become cost saving.
CONCLUSIONS


Short duration hospitalization protocols to treat appendicitis nonoperatively with antibiotics are cost saving under almost all model scenarios. Future consideration of patient preferences and health-related quality of life will need to be made to determine if short stay treatment protocols are cost-effective.",2020,"The short stay treatment protocol costs $8026 per patient, and the ED discharge protocol costs $6,825, which was $2709 and $3910 less than the long stay protocol, respectively.",['Acute Uncomplicated Appendicitis'],"['3-d hospital stay for intravenous antibiotics', 'Nonoperative management (NOM']","['ED discharge protocol costs', 'short stay treatment protocol costs', 'stay (3-d hospitalization), (2) short stay (1-d hospitalization), and (3) emergency department (ED) discharge', 'total 5-y projected cost']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}]",,0.0383425,"The short stay treatment protocol costs $8026 per patient, and the ED discharge protocol costs $6,825, which was $2709 and $3910 less than the long stay protocol, respectively.","[{'ForeName': 'Max A', 'Initials': 'MA', 'LastName': 'Schumm', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California. Electronic address: mschumm@mednet.ucla.edu.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Childers', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'James X', 'Initials': 'JX', 'LastName': 'Wu', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'Kyle A', 'Initials': 'KA', 'LastName': 'Zanocco', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}]",The Journal of surgical research,['10.1016/j.jss.2020.05.028']
1141,32536123,[A multicenter randomized prospective study of concurrent chemoradiation with 60 Gy versus 50 Gy for inoperable esophageal squamous cell carcinoma].,"Objective:  To determine whether 60 Gy is superior to standard 50 Gy for definitive concurrent chemoradiation(CCRT) in esophageal squamous cell carcinoma (ESCC) using modern radiation technology in a phase Ⅲ prospective randomized trial.  Methods:  From April 2013 to May 2017, 331 patients from 22 hospitals who were pathologically confirmed with stage ⅢA-ⅣA ESCC were randomized to 60 Gy or 50 Gy with random number table. Total of 305 patients were analyzed, including 152 in 60 Gy group and 153 in 50 Gy group. The median age was 63 years, 242(79.3%) males and 63(20.7%) females. The median length of primary tumor was 5.6 cm. The clinical characteristics between two groups were comparable. All patients were delivered 2 Gy per fraction, 5 fractions per week. Concurrent weekly chemotherapy with docetaxel (25 mg/m(2)) and cisplatin (25 mg/m(2)) and 2 cycles consolidation chemotherapy with docetaxel (70 mg/m(2)) and cisplatin (25 mg/m(2), d1-3) were administrated. The primary endpoint was local/regional progression-free survival (LRPFS). The data were compared with Pearson chi-square test or Fisher's exact test.  Results:  At a median follow-up of 27.3 months, the disease progression rate was 37.5% (57/152), 43.8% (67/153) in the high and standard-dose group, respectively (χ(2)=1.251,  P= 0.263). The 1, 2, 3-year LRPFS rate was 75.4%, 56.8%, 52.1% and 74.2%, 58.4%, 50.1%, respectively ( HR : 0.95, 95 %CI : 0.69-1.31,  P= 0.761). The 1, 2, 3-year overall survival rate was 84.1%, 64.8%, 54.1% and 85.4%, 62.9%, 54.0%, respectively ( HR : 0.98, 95 %CI : 0.71-1.38,  P= 0.927). The 1, 2, 3-year progression-free survival rate was 70.8%, 54.2%, 48.5% and 65.5%, 51.9%, 45.1%, respectively ( HR : 0.93, 95 %CI : 0.68-1.26,  P= 0.621). The incidence rates in toxicities between the two groups were similar except for higher rate of severe pneumonitis in high dose group (χ(2)=11.596,  P= 0.021).  Conclusions:  The efficacy in disease control is similar between 60 Gy and 50 Gy using modern radiation technology concurrent with chemotherapy for ESCC. The 50 Gy should be recommended as the regular radiation dose with CCRT for ESCC.",2020,The efficacy in disease control is similar between 60 Gy and 50 Gy using modern radiation technology concurrent with chemotherapy for ESCC.,"['Total of 305 patients were analyzed, including 152 in 60 Gy group and 153 in 50 Gy group', 'Methods:  From April 2013 to May 2017, 331 patients from 22 hospitals who were pathologically confirmed with stage ⅢA-ⅣA ESCC', 'esophageal squamous cell carcinoma (ESCC', 'inoperable esophageal squamous cell carcinoma', 'The median age was 63 years, 242(79.3%) males and 63(20.7%) females']","['cisplatin (25 mg/m(2)) and 2 cycles consolidation chemotherapy with docetaxel', 'concurrent chemoradiation with 60 Gy versus 50 Gy', 'chemotherapy with docetaxel', 'cisplatin', 'standard 50 Gy for definitive concurrent chemoradiation(CCRT']","['incidence rates in toxicities', '3-year overall survival rate', 'local/regional progression-free survival (LRPFS', 'median length of primary tumor', 'disease progression rate', 'severe pneumonitis', '3-year LRPFS rate', '3-year progression-free survival rate']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C3179017', 'cui_str': 'Consolidation Chemotherapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3714636', 'cui_str': 'Pneumonitis'}]",305.0,0.101413,The efficacy in disease control is similar between 60 Gy and 50 Gy using modern radiation technology concurrent with chemotherapy for ESCC.,"[{'ForeName': 'Y J', 'Initials': 'YJ', 'LastName': 'Xu', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, the Department of Thoracic Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences; Zhejiang Cancer Hospital, Hangzhou 310022, China.'}, {'ForeName': 'W G', 'Initials': 'WG', 'LastName': 'Zhu', 'Affiliation': ""the Department of Radiation Oncology, Huai'an First People's Hospital, Huai'an 223300, China.""}, {'ForeName': 'Z X', 'Initials': 'ZX', 'LastName': 'Liao', 'Affiliation': 'the Department of Radiation Oncology, University of Taxes, M.D. Anderson Cancer Center, Houston 77030, the United States.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Kong', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, the Department of Thoracic Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences; Zhejiang Cancer Hospital, Hangzhou 310022, China.'}, {'ForeName': 'W W', 'Initials': 'WW', 'LastName': 'Wang', 'Affiliation': ""the Department of Radiation Oncology, Huai'an First People's Hospital, Huai'an 223300, China.""}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Li', 'Affiliation': 'the Department of Thoracic Radiation Oncology, Fujian Cancer Hospital, Fuzhou 350014, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Huang', 'Affiliation': ""the Department of Radiation Oncology, Foshan First People's Hospital, Foshan 528000, China.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'He', 'Affiliation': ""the Department of Radiation Oncology, Foshan First People's Hospital, Foshan 528000, China.""}, {'ForeName': 'X M', 'Initials': 'XM', 'LastName': 'Yang', 'Affiliation': ""the Department of Medical Oncology, Jiaxing First People's Hospital, Jiaxing 314000, China.""}, {'ForeName': 'L P', 'Initials': 'LP', 'LastName': 'Liu', 'Affiliation': ""the Department of Oncology, Jining First People's Hospital, Jining 272011, China.""}, {'ForeName': 'Z W', 'Initials': 'ZW', 'LastName': 'Sun', 'Affiliation': ""the Department of Oncology, Jining First People's Hospital, Jining 272011, China.""}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'He', 'Affiliation': ""the Department of Radiation Oncology, Quzhou People's Hospital, Quzhou 324000, China.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': 'the Department of Radiation Oncology, Affiliated Cancer Hospital, Sun Yat-Sen University, Guangzhou 510080, China(is working in the First Affiliated Hospital of Sun Yat-Sen University).'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': ""the Department of Radiation Oncology, Sichuan Provincial People's Hospital, Chengdu 610072, China.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pu', 'Affiliation': ""the Department of Radiation Oncology, Lianshui People's Hospital, Lianshui 223400, China.""}, {'ForeName': 'W Y', 'Initials': 'WY', 'LastName': 'Hu', 'Affiliation': 'the Department of Radiation Oncology, Jinhua Central Hospital, Jinhua 321000, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'the Department of Radiation Oncology, Anhui Provincial Hospital, Hefei 230001, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'the Department of Radiation Oncology, Affiliated Hospital of Bengbu Medical College, Bengbu 233004, China.'}, {'ForeName': 'Z G', 'Initials': 'ZG', 'LastName': 'Liu', 'Affiliation': 'the Department of Radiation Oncology, Hunan Cancer Hospital, Changsha 410013, China(is working in the Fifth Affiliated Hospital of Sun Yat-Sen University now).'}, {'ForeName': 'T T', 'Initials': 'TT', 'LastName': 'Zhuang', 'Affiliation': 'the Department of Radiation Oncology, Affiliated Cancer Hospital of Shantou University Medical College, Shantou 515031, China.'}, {'ForeName': 'B X', 'Initials': 'BX', 'LastName': 'Tan', 'Affiliation': 'the Department of Radiation Oncology, Affiliated Hospital of North Sichuan Medical College, Nanchong 637000, China.'}, {'ForeName': 'X H', 'Initials': 'XH', 'LastName': 'Du', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, the Department of Thoracic Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences; Zhejiang Cancer Hospital, Hangzhou 310022, China.'}, {'ForeName': 'G Q', 'Initials': 'GQ', 'LastName': 'Qiu', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, the Department of Thoracic Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences; Zhejiang Cancer Hospital, Hangzhou 310022, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, the Department of Thoracic Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences; Zhejiang Cancer Hospital, Hangzhou 310022, China.'}, {'ForeName': 'Y L', 'Initials': 'YL', 'LastName': 'Ji', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, the Department of Thoracic Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences; Zhejiang Cancer Hospital, Hangzhou 310022, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, the Department of Thoracic Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences; Zhejiang Cancer Hospital, Hangzhou 310022, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, the Department of Thoracic Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences; Zhejiang Cancer Hospital, Hangzhou 310022, China.'}, {'ForeName': 'H L', 'Initials': 'HL', 'LastName': 'Ma', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, the Department of Thoracic Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences; Zhejiang Cancer Hospital, Hangzhou 310022, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, the Department of Thoracic Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences; Zhejiang Cancer Hospital, Hangzhou 310022, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': ""the Department of Radiation Oncology, Changzhou First People's Hospital, Changzhou 213003, China.""}, {'ForeName': 'A W', 'Initials': 'AW', 'LastName': 'Liu', 'Affiliation': 'the Department of Radiation Oncology, Second Affiliated Hospital of Nanchang University, Nanchang 330006, China.'}, {'ForeName': 'X D', 'Initials': 'XD', 'LastName': 'Liang', 'Affiliation': ""the Department of Radiation Oncology, Zhejiang People's Hospital, Hangzhou 310014, China.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tao', 'Affiliation': 'the Department of Radiation Oncology, Jiangsu Cancer Hospital, Nanjing 210009, China.'}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Zhou', 'Affiliation': 'the Department of Radiation Oncology, First Affiliated Hospital of Suzhou University, Suzhou 215006, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'the Department of Radiation Oncology, Affiliated Cancer Hospital of Guangzhou Medical University, Guangzhou 510095, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, the Department of Thoracic Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences; Zhejiang Cancer Hospital, Hangzhou 310022, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20200303-00574']
1142,32548702,"Association of diabetes-related autoantibodies with the incidence of asthma, eczema and allergic rhinitis in the TRIGR randomised clinical trial.","AIMS/HYPOTHESIS


This paper presents the relationship between islet autoantibodies, precursors of type 1 diabetes, and the development of persistent asthma, allergic rhinitis and atopic eczema.
METHODS


A total of 2159 newborns who had a first-degree relative with type 1 diabetes and selected HLA genotypes were followed until the youngest participant reached 10 years of age. Islet cell antibodies (ICA) were detected using indirect immunofluorescence. Autoantibodies to insulin (IAA), GAD (GADA), the tyrosine phosphatase-related insulinoma-associated 2 molecule (IA-2A) and zinc transporter 8 (ZnT8A) were quantified with the use of specific radiobinding assays. As an ancillary study, the incidence of asthma, allergic rhinitis and eczema was assessed in 1106 of these children using the International Study of Asthma and Allergies in Childhood (ISAAC) core questionnaire when the children were 9-11 years old. HRs with 95% CIs were calculated to depict the incidence of these diseases following seroconversion to autoantibody positivity.
RESULTS


The cumulative incidence of atopic eczema, allergic rhinitis and persistent asthma were 22%, 9% and 7.5%, respectively, by 9-11 years of age. The occurrence of diabetes-related autoantibodies showed a protective association with subsequently reported incidence of asthma and eczema. The incidence of rhinitis was not significantly related to the occurrence of IAA or GADA (statistical power was limited), but demonstrated the same inverse relationship as did the other diseases with ICA or when multiple autoantibodies first appeared together.
CONCLUSIONS/INTERPRETATION


The findings add evidence to the relationships between these atopic diseases and diabetes-related autoimmunity and also suggest that, for eczema, the interaction depends upon which autoantibody appeared first.
TRIAL REGISTRATION


ClinicalTrials.gov NCT00179777 Graphical abstract.",2020,"The incidence of rhinitis was not significantly related to the occurrence of IAA or GADA (statistical power was limited), but demonstrated the same inverse relationship as did the other diseases with ICA or when multiple autoantibodies first appeared together.
","['2159 newborns who had a first-degree relative with type 1 diabetes and selected HLA genotypes were followed until the youngest participant reached 10\xa0years of age', '1106 of these children using the International Study of Asthma and Allergies in Childhood (ISAAC) core questionnaire when the children were 9-11\xa0years old']",[],"['occurrence of IAA or GADA', 'cumulative incidence of atopic eczema, allergic rhinitis and persistent asthma', 'incidence of asthma, allergic rhinitis and eczema', 'Autoantibodies to insulin (IAA), GAD (GADA', 'incidence of rhinitis', 'Islet cell antibodies (ICA']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0444502', 'cui_str': 'First degree'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0004358', 'cui_str': 'Autoantibody'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder'}, {'cui': 'C0008711', 'cui_str': 'Chronic rhinitis'}, {'cui': 'C0063900', 'cui_str': 'Anti-pancreatic islet cell antibody'}]",2159.0,0.0442462,"The incidence of rhinitis was not significantly related to the occurrence of IAA or GADA (statistical power was limited), but demonstrated the same inverse relationship as did the other diseases with ICA or when multiple autoantibodies first appeared together.
","[{'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Krischer', 'Affiliation': 'Health Informatics Institute, Morsani College of Medicine, University of South Florida, 3650 Spectrum Boulevard, Suite 100, Tampa, FL, 33612, USA. jeffrey.krischer@epi.usf.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cuthbertson', 'Affiliation': 'Health Informatics Institute, Morsani College of Medicine, University of South Florida, 3650 Spectrum Boulevard, Suite 100, Tampa, FL, 33612, USA.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Couluris', 'Affiliation': 'Department of Pediatrics, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Knip', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Suvi M', 'Initials': 'SM', 'LastName': 'Virtanen', 'Affiliation': 'Unit of Public Health Promotion, National Institute for Health and Welfare, Helsinki, Finland.'}]",Diabetologia,['10.1007/s00125-020-05188-3']
1143,32546421,Small changes in glucose variability induced by low and high glycemic index diets are not associated with changes in β-cell function in adults with pre-diabetes.,"Oscillating glucose levels can increase oxidative stress and may contribute to β-cell dysfunction. We tested the hypothesis that increased glycemic variability contributes to β-cell dysfunction by experimentally altering glucose variability with controlled diets varying in glycemic index (GI). Fifty-two adults with prediabetes received a 2-week moderate GI (GI = 55-58) control diet followed by randomization to a four-week low GI (LGI: GI < 35) or high GI (HGI HI > 70) diet. Those on the HGI diet were randomized to placebo or the antioxidant N-acetylcysteine (NAC). Participants underwent blinded CGMS, fasting oxidative stress markers and an intravenous glucose tolerance test to estimate β-cell function (disposition index: DI). On the control diet, DI was inversely correlated with SD glucose (r = -0.314, p = 0.03), but neither DI nor glucose variability were associated with oxidative stress markers. The LGI diet decreased SD glucose (Control 0.96 ± 0.08 vs. LGI 0.79 ± 0.06, p = 0.02) while the HGI diet increased it (Control 0.88 ± 0.06 vs. HGI 1.06 ± 0.07, p = 0.03). Neither DI nor oxidative stress markers changed after the LGI or HGI diets. NAC had no effect on DI, glucose variability or oxidative stress markers. We conclude small changes in glucose variability induced by dietary GI in adults with pre-diabetes are unlikely to contribute to β-cell dysfunction.",2020,"The LGI diet decreased SD glucose (Control 0.96 ± 0.08 vs. LGI 0.79 ± 0.06, p = 0.02) while the HGI diet increased it (Control 0.88 ± 0.06 vs. HGI 1.06 ± 0.07, p = 0.03).","['Fifty-two adults with prediabetes received a', 'adults with pre-diabetes']","['2-week moderate GI (GI\u202f=\u202f55-58) control diet followed by randomization to a four-week low GI (LGI: GI\u202f<\u202f35) or high GI (HGI HI', 'antioxidant N-acetylcysteine (NAC', 'NAC', 'placebo']","['oxidative stress markers', 'oxidative stress', 'SD glucose', 'glucose variability', 'β-cell function', 'DI, glucose variability or oxidative stress markers']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}]",52.0,0.0150612,"The LGI diet decreased SD glucose (Control 0.96 ± 0.08 vs. LGI 0.79 ± 0.06, p = 0.02) while the HGI diet increased it (Control 0.88 ± 0.06 vs. HGI 1.06 ± 0.07, p = 0.03).","[{'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Utzschneider', 'Affiliation': 'Research and Development, Department of Medicine, 1660 S Columbian Way (151), VA Puget Sound Health Care System, Seattle, WA 98108, USA; Division of Metabolism, Endocrinology and Nutrition, University of Washington, 1959 NE Pacific Street, Seattle, WA 98195-6426, USA. Electronic address: kutzschn@uw.edu.'}, {'ForeName': 'Tonya N', 'Initials': 'TN', 'LastName': 'Johnson', 'Affiliation': 'Research and Development, Department of Medicine, 1660 S Columbian Way (151), VA Puget Sound Health Care System, Seattle, WA 98108, USA; Seattle Institute for BIomedical and Clinical Research, Seattle, WA, USA.'}, {'ForeName': 'Kara L', 'Initials': 'KL', 'LastName': 'Breymeyer', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA 98109, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Bettcher', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, 1959 NE Pacific Street, Seattle, WA 98195-6426, USA. Electronic address: bettcher@uw.edu.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Raftery', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, 1959 NE Pacific Street, Seattle, WA 98195-6426, USA. Electronic address: draftery@uw.edu.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Newton', 'Affiliation': 'Kaiser Permanente Health Research Institute, 1730 Minor Ave, Seattle, WA 98101, USA. Electronic address: Katherine.M.Newton@kp.org.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Neuhouser', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA 98109, USA. Electronic address: mneuhous@fredhutch.org.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2020.107586']
1144,32552207,"Re: Long-Term Oncological Outcomes from an Early Phase Randomised Controlled Three-Arm Trial of Open, Robotic, and Laparoscopic Radical Cystectomy (CORAL).",,2020,,[],"['Open, Robotic, and Laparoscopic Radical Cystectomy (CORAL']",[],[],"[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0324034', 'cui_str': 'Coral'}]",[],,0.0947995,,"[{'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Cadeddu', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001166']
1145,32554025,swCRTdesign: An R Package for Stepped Wedge Trial Design and Analysis.,"BACKGROUND AND OBJECTIVE


Stepped wedge trials (SWTs) are a type of cluster-randomized trial that are commonly used to evaluate health care interventions. Most SWT-related software packages have restrictive assumptions about the study design and correlation structure of the data. The objective of this paper is to present a package and corresponding web-based graphical user interface (GUI) that provide researchers with another, more flexible option for SWT design and analysis.
METHODS


We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design. Possible sources of correlation include clusters, time within clusters, and treatment within clusters.
RESULTS


swCRTdesign allows a user to calculate power, simulate SWT data to streamline simulation studies (e.g. to estimate power), and create descriptive summaries and plots. Additionally, a GUI, developed using shiny, is available to calculate power and create power curves and design plots.
CONCLUSIONS


The swCRTdesign package accommodates a wide variety of SWT designs, and makes it easy to account for some sources of correlation which are not found in other packages. The user-friendly web-based GUI makes some swCRTdesign features accessible to researchers not familiar with R. These two resources will make appropriately complex SWT calculations more accessible to scientists from a wide variety of backgrounds.",2020,"We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design.",[],['swCRTdesign'],[],[],[],[],,0.150645,"We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design.","[{'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Voldal', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States. Electronic address: voldal@uw.edu.'}, {'ForeName': 'Navneet R', 'Initials': 'NR', 'LastName': 'Hakhu', 'Affiliation': 'Department of Statistics, University of California, Irvine, Irvine, CA 92697, United States.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Xia', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Hughes', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}]",Computer methods and programs in biomedicine,['10.1016/j.cmpb.2020.105514']
1146,32555047,"Effect of NSAID Use on Bone Healing in Pediatric Fractures: A Preliminary, Prospective, Randomized, Blinded Study.","BACKGROUND


This study aimed to investigate if nonsteroidal anti-inflammatory drugs (NSAIDs) used in the acute phase of bone healing in children with fractures result in delayed union or nonunion as compared with patients who do not take NSAIDs for pain control during this same time period.
METHODS


In this prospective, randomized, parallel, single-blinded study, skeletally immature patients with long bone fractures were randomized to 1 of 2 groups for their postfracture pain management. The NSAID group was prescribed weight-based ibuprofen, whereas the control group was not allowed any NSAID medication and instead prescribed weight-based acetaminophen. Both groups were allowed to use oxycodone for breakthrough pain. The primary outcome was fracture healing assessed at 2, 6, and 10 weeks.
RESULTS


One-hundred-two patients were enrolled between February 6, 2014 and September 23, 2016. Ninety-five patients (with 97 fractures) completed a 6-month follow-up (46 patients with 47 fractures in the control group and 49 patients 50 fractures in the NSAID group). None achieved healing at 1 to 2 weeks. By 6 weeks, 37 of 45 patients (82%) of control group and 46 out of 50 patients (92%) of ibuprofen group had healed fractures (P=0.22). At 10 to 12 week follow-up, 46 (98%) of the control group fractures were healed and 50 (100%) of the ibuprofen group fractures were healed. All were healed by 6 months. Healing was documented at a mean of 40 days in the control group and 31 days in the ibuprofen group (P=0.76). The mean number of days breakthrough oxycodone was used was 2.4 days in the control group and 1.9 days in the NSAID group (P=0.48).
CONCLUSION


Ibuprofen is an effective medication for fracture pain in children and its use does not impair clinical or radiographic long bone fracture healing in skeletally immature patients.
LEVEL OF EVIDENCE


Level I-therapeutic.",2020,Healing was documented at a mean of 40 days in the control group and 31 days in the ibuprofen group (P=0.76).,"['One-hundred-two patients were enrolled between February 6, 2014 and September 23, 2016', 'skeletally immature patients', 'Pediatric Fractures', 'Ninety-five patients (with 97 fractures) completed a 6-month follow-up (46 patients with 47 fractures in the control group and 49 patients 50 fractures in the NSAID group', 'skeletally immature patients with long bone fractures', 'children with fractures result in delayed union or nonunion as compared with patients who do not take NSAIDs for pain control during this same time period']","['NSAID', 'nonsteroidal anti-inflammatory drugs (NSAIDs', 'Ibuprofen', 'oxycodone', 'ibuprofen', 'acetaminophen']","['healing', 'healed fractures', 'Bone Healing', 'fracture healing', 'mean number of days breakthrough oxycodone', 'Healing']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205252', 'cui_str': 'Immature'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0222647', 'cui_str': 'Structure of long bone'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}]","[{'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0152231', 'cui_str': 'Fracture, healed'}, {'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}]",102.0,0.0423132,Healing was documented at a mean of 40 days in the control group and 31 days in the ibuprofen group (P=0.76).,"[{'ForeName': 'Julia A V', 'Initials': 'JAV', 'LastName': 'Nuelle', 'Affiliation': 'Department of Orthopaedic Surgery, University of Missouri Health System, Columbia, MO.'}, {'ForeName': 'Kelsie M', 'Initials': 'KM', 'LastName': 'Coe', 'Affiliation': ''}, {'ForeName': 'Harvey A', 'Initials': 'HA', 'LastName': 'Oliver', 'Affiliation': ''}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Cook', 'Affiliation': ''}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Hoernschemeyer', 'Affiliation': ''}, {'ForeName': 'Sumit K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': ''}]",Journal of pediatric orthopedics,['10.1097/BPO.0000000000001603']
1147,32555148,Effect of bolus enteral tube feeding on body weight in ambulatory adults with obesity and type 2 diabetes: a feasibility pilot randomized trial.,"BACKGROUND/OBJECTIVES


To ascertain the effect on body weight of 14 days of bolus enteral feeding with mixed meal (MM) and electrolyte solution (ES) in ambulatory adults with type 2 diabetes and obesity, and also the safety and feasibility of using a modified, intraorally anchored enteral feeding tube for this purpose.
SUBJECTS/METHODS


We conducted a randomized, crossover pilot trial with 16 participants. A 140 cm, 8-French feeding tube was placed in the jejunum under electromagnetic guidance and anchored intraorally. Participants were randomized to self-administer 120 mL 523 kJ (125 kcal) MM, or 50 kJ (12 kcal) ES four times/day for 14 days. After ≥14 days without the tube, participants crossed over to the other treatment. The primary outcome compared weight change between treatments. Thereafter, participants could elect to undergo additional MM cycles. Participants were encouraged to continue with all usual activities including eating ad lib throughout the study.
RESULTS


Ten participants withdrew prior to completing two randomized 14-day cycles (4 social, 3 intolerant of anchor, and 3 intolerant of tube). Six participants were assessed for the primary outcome and showed no significant difference in weight loss between MM and ES (p = 0.082). For the secondary outcome of within-group weight loss, average weight loss from baseline was significant for MM but not for ES: -2.40 kg (95% CI: -3.78, -1.02; p = 0.008) vs. -0.64 kg (95% CI: -2.01, 0.74; p = 0.27). A total of 23 2-week cycles were completed (12 paired, 2 unpaired, and 9 additional), with no significant adverse events for 334 days of tube use.
CONCLUSIONS


Repeated bolus nutrient administration via enteral feeding tube is associated with weight loss in adults with obesity and type 2 diabetes, with no significant difference seen between MM and ES feeds. The prototype device was safe, but requires development for further investigation into the effect of bolus jejunal feeding on weight and to improve acceptability.",2020,Six participants were assessed for the primary outcome and showed no significant difference in weight loss between MM and ES (p = 0.082).,"['adults with obesity and type 2 diabetes', 'ambulatory adults with obesity and type 2 diabetes', 'ambulatory adults with type 2 diabetes and obesity', '16 participants']","['bolus enteral tube feeding', 'bolus enteral feeding with mixed meal (MM) and electrolyte solution (ES']","['body weight', 'weight loss', 'weight loss, average weight loss', 'weight change']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0041281', 'cui_str': 'Tube feeding of patient'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C3541941', 'cui_str': 'Electrolyte solutions'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",6.0,0.0865442,Six participants were assessed for the primary outcome and showed no significant difference in weight loss between MM and ES (p = 0.082).,"[{'ForeName': 'E O', 'Initials': 'EO', 'LastName': 'Beale', 'Affiliation': 'Division of Endocrinology and Diabetes, Keck School of Medicine, University of Southern California, Los Angeles, 90033, CA, USA. beale@usc.edu.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Diabetes, Keck School of Medicine, University of Southern California, Los Angeles, 90033, CA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Diabetes, Keck School of Medicine, University of Southern California, Los Angeles, 90033, CA, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Diabetes, Keck School of Medicine, University of Southern California, Los Angeles, 90033, CA, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Soffer', 'Affiliation': 'Division of Gastroenterology, Keck School of Medicine, University of Southern California, Los Angeles, 90033, CA, USA.'}, {'ForeName': 'P F', 'Initials': 'PF', 'LastName': 'Crookes', 'Affiliation': 'Division of Foregut Surgery, Keck School of Medicine, University of Southern California, Los Angeles, 90033, CA, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Eagilen', 'Affiliation': 'Edward R. Roybal Comprehensive Health Center Dental Clinic, East Los Angeles, 90022, CA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Edward R. Roybal Comprehensive Health Center Dental Clinic, East Los Angeles, 90022, CA, USA.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Mack', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, 90033, CA, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tong', 'Affiliation': 'Herman Ostrow School of Dentistry University of Southern California, Los Angeles, 90033, CA, USA.'}]",Nutrition & diabetes,['10.1038/s41387-020-0125-6']
1148,32559716,A randomized controlled trial of digital cognitive behavioral therapy for insomnia in pregnant women.,"OBJECTIVE


Despite high rates of prenatal insomnia, efficacious treatment options for this population are quite limited. Early evidence from randomized controlled trials (RCTs) support the efficacy of face-to-face cognitive-behavioral therapy for insomnia (CBTI) for prenatal insomnia. Yet, as many patients are unable to access this specialist-driven care, a critical need exists to increase its accessibility. This RCT examined the efficacy internet-based digital CBTI in pregnant women with insomnia.
METHODS


Single-site RCT. A total of 91 pregnant women (29.03 ± 4.16 years) nearing/entering the third trimester who screened positive for clinical insomnia on the Insomnia Severity Index (ISI) were randomized to digital CBTI or digital sleep education control. The ISI, Pittsburgh Sleep Quality Index (PSQI), Edinburgh Postnatal Depression Scale (EPDS), and Pre-Sleep Arousal Scale's Cognitive factor (PSAS-C) served as study outcomes, which were collected before treatment and after treatment during pregnancy, then six weeks after childbirth.
RESULTS


From pre to posttreatment, CBTI patients reported reductions in ISI (-4.91 points, p < 0.001) and PSQI (-2.98 points, p < 0.001) and increases in nightly sleep duration by 32 min (p = 0.008). Sleep symptoms did not change during pregnancy in the control group. After childbirth, CBTI patients, relative to controls, slept longer by 40 min per night (p = 0.01) and reported better sleep maintenance. No pre or postnatal treatment effects on depression or cognitive arousal were observed.
CONCLUSIONS


Digital CBTI improves sleep quality and sleep duration during pregnancy and after childbirth. To better optimize outcomes, CBTI should be tailored to meet the changing needs of women as the progress through pregnancy and early parenting. NAME: Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression. URL: clinicaltrials.gov. Registration: NCT03596879.",2020,"From pre to posttreatment, CBTI patients reported reductions in ISI (-4.91 points, p < 0.001) and PSQI (-2.98 points, p < 0.001) and increases in nightly sleep duration by 32 min (p = 0.008).","['insomnia (CBTI) for prenatal insomnia', 'pregnant women with insomnia', '91 pregnant women (29.03\xa0±\xa04.16 years) nearing/entering the third trimester who screened positive for clinical insomnia on the Insomnia Severity Index (ISI', 'pregnant women']","['Digital CBTI', 'digital CBTI or digital sleep education control', 'digital cognitive behavioral therapy', 'face-to-face cognitive-behavioral therapy', 'NAME']","['nightly sleep duration', 'PSQI', 'sleep quality and sleep duration', 'sleep maintenance', 'ISI', 'depression or cognitive arousal', ""ISI, Pittsburgh Sleep Quality Index (PSQI), Edinburgh Postnatal Depression Scale (EPDS), and Pre-Sleep Arousal Scale's Cognitive factor (PSAS-C"", 'Sleep symptoms', 'Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}]",91.0,0.126542,"From pre to posttreatment, CBTI patients reported reductions in ISI (-4.91 points, p < 0.001) and PSQI (-2.98 points, p < 0.001) and increases in nightly sleep duration by 32 min (p = 0.008).","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kalmbach', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA. Electronic address: dkalmba1@hfhs.org.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': ""O'Brien"", 'Affiliation': 'Departments of Obstetrics & Gynecology and Neurology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Swanson', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Roopina', 'Initials': 'R', 'LastName': 'Sangha', 'Affiliation': 'Department of Obstetrics & Gynecology, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Srijan', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Guille', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cuamatzi-Castelan', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Alasdair L', 'Initials': 'AL', 'LastName': 'Henry', 'Affiliation': 'Big Health Inc, San Francisco, CA, USA; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Roth', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}]",Sleep medicine,['10.1016/j.sleep.2020.03.016']
1149,32562433,Effects of illness representation-focused patient education on illness representations and self-care in patients with heart failure: A randomised clinical trial.,"AIMS AND OBJECTIVES


To examine the effect of an illness representation-focused patient education intervention on illness representations and self-care behaviours in patients with heart failure 3 months after discharge from the hospital.
BACKGROUND


Few intervention studies have examined the effect of illness representation-focused interventions on illness representations and self-care in patients with heart failure.
DESIGN


A randomised clinical trial based on the Consolidated Standard of Reporting Trials-CONSORT 2010-guidelines was employed. The Clinical Trial Registry number is TCTR20190903002.
METHODS


One hundred and seven participants were randomly assigned to 2 groups, and 62 participants (n = 30 in the intervention group and n = 32 in the usual care group) completed the baseline and one- and three-month postdischarge follow-up assessments. The instruments included the Survey of Illness Beliefs in Heart Failure and the Self-care of Heart Failure Index. The intervention group received illness representation-focused patient education while hospitalised and telephone follow-ups after discharge. Data were analysed with linear mixed-effects model analysis.
RESULTS


The 107 participants had a mean age of 62.17 years and a mean left ventricular ejection of 53.03%. At baseline, the two groups tended to have accurate illness beliefs but insufficient self-care confidence and self-care maintenance. The analysis showed no significant differences between groups in the illness representation total scores, dimension scores or self-care maintenance scores but did show a significant difference in the self-care confidence scores (F = 3.42, p < .05) over the three months.
CONCLUSION


The study did not show an effect of the intervention on illness representations or self-care maintenance behaviours. However, the intervention did maintain participants' self-care confidence three months after discharge.
RELEVANCE TO CLINICAL PRACTICE


It is necessary to conduct long-term follow-ups of patients' illness representations, discuss the implementation of self-care behaviours with patients, enhance patients' self-care confidence, and involve family members or caregivers in self-care practices when needed.",2020,"The analysis showed no significant differences between groups in the illness representation total scores, dimension scores or self-care maintenance scores but did show a significant difference in the self-care confidence scores (F = 3.42, p < .05) over the three months.
","['patients with heart failure three months after discharge from the hospital', '107 participants had a mean age of 62.17 years and a mean left ventricular ejection of 53.03', 'One hundred seven participants were randomly assigned to 2 groups, and 62 participants (n = 30 in the intervention group and n = 32 in the', 'Patients with Heart Failure', 'patients with heart failure']","['illness representation-focused patient education intervention', 'Illness Representation-Focused Patient Education', 'illness representation-focused patient education while hospitalized and telephone follow-ups after discharge', 'usual care group) completed the baseline and one- and three-month post-discharge follow-up assessments']","['illness representations or self-care maintenance behaviours', 'illness representations and self-care behaviours', 'illness representation total scores, dimension scores or self-care maintenance scores', 'Survey of Illness Beliefs in Heart Failure and the Self-care of Heart Failure Index', 'Illness Representations and Self-care', 'self-care confidence scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2733342', 'cui_str': 'Left ventricular ejection'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C1320368', 'cui_str': 'Post-discharge follow-up'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",107.0,0.121429,"The analysis showed no significant differences between groups in the illness representation total scores, dimension scores or self-care maintenance scores but did show a significant difference in the self-care confidence scores (F = 3.42, p < .05) over the three months.
","[{'ForeName': 'Wan-Tzu', 'Initials': 'WT', 'LastName': 'Chang', 'Affiliation': 'Department of Nursing, National Cheng Kung University Hospital, Tainan, Taiwan.'}, {'ForeName': 'Shan-Tair', 'Initials': 'ST', 'LastName': 'Wang', 'Affiliation': 'Ditmanson Medical Foundation Chiayi Christian Hospital, Chiayi City, Taiwan.'}, {'ForeName': 'Chi-Hsin', 'Initials': 'CH', 'LastName': 'Hsu', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Liang-Miin', 'Initials': 'LM', 'LastName': 'Tsai', 'Affiliation': 'Department of Internal Medicine, Tainan Municipal Hospital, Tainan, Taiwan.'}, {'ForeName': 'Shih-Hung', 'Initials': 'SH', 'LastName': 'Chan', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Hsing-Mei', 'Initials': 'HM', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}]",Journal of clinical nursing,['10.1111/jocn.15384']
1150,32567518,A Clustered Randomized Trial Informing Patients on Dialysis About Their Ability to Donate Organs and Tissues.,"INTRODUCTION


The transplant waiting list exceeds the number of organs available. One means of increasing the organ pool is to broaden potential donors to include those with chronic diseases.
RESEARCH QUESTIONS


The study tested the effectiveness of using peer mentors to encourage individuals on dialysis to enroll on an organ donor registry.
DESIGN


Dialysis units were pair-matched by size and racial composition and then randomized to one of 2 interventions: meetings with a peer mentor (experimental intervention) or organ donation mailings (control). Peer mentors were trained to discuss organ donation with individuals on dialysis during in-person meetings at dialysis units. The primary outcome was verified registration in the state's donor registry.
RESULTS


After adjusting for age, gender, race, income, and education and accounting for correlation within the dialysis center, there was a significant intervention effect. Among individuals in the intervention group, the odds of enrolling (verified) on the donor registry were 2.52 times higher than those in the control group.
DISCUSSION


The use of peer mentors to discuss donating organs after death with individuals on dialysis can increase enrollment on a donor registry. Dispelling myths about chronic illness and donation can counter widely held misconceptions and help persons make an informed choice about end-of-life decisions and present an opportunity to increase the number of organs and tissues available for transplant.",2020,"Among individuals in the intervention group, the odds of enrolling (verified) on the donor registry were 2.52 times higher than those in the control group.
",[],['peer mentor (experimental intervention) or organ donation mailings (control'],"[""verified registration in the state's donor registry""]",[],"[{'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]",,0.028342,"Among individuals in the intervention group, the odds of enrolling (verified) on the donor registry were 2.52 times higher than those in the control group.
","[{'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Andrews', 'Affiliation': '456953National Kidney Foundation of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Nanhua', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': ""Division of Biostatistics and Epidemiology, 2518Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Allyce Haney', 'Initials': 'AH', 'LastName': 'Smith', 'Affiliation': 'Greenfield Health Systems, Bingham Farms, MI, USA.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Loughery', 'Affiliation': '456953National Kidney Foundation of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Department of Health Behavior & Health Education, 51329University of Michigan School of Public Health, Ann Arbor, MI, USA.'}, {'ForeName': 'Remonia', 'Initials': 'R', 'LastName': 'Chapman', 'Affiliation': 'Gift of Life Michigan, Minority Organ and Tissue Transplant Education Program, Ann Arbor, MI, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Jenkins Riley', 'Affiliation': 'Greenfield Health Systems, Bingham Farms, MI, USA.'}, {'ForeName': 'Sheri', 'Initials': 'S', 'LastName': 'Stav', 'Affiliation': 'Greenfield Health Systems, Bingham Farms, MI, USA.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Yee', 'Affiliation': '2971Henry Ford Health System, Detroit, MI, USA.'}]","Progress in transplantation (Aliso Viejo, Calif.)",['10.1177/1526924820933840']
1151,32568196,"Safety, Tolerability, and Pharmacokinetics of Crenezumab in Patients with Mild-to-Moderate Alzheimer's Disease Treated with Escalating Doses for up to 133 Weeks.","BACKGROUND


Crenezumab is a fully humanized, monoclonal anti-amyloid-β immunoglobulin G4 antibody.
OBJECTIVE


This Phase Ib study (NCT02353598) evaluated the safety, tolerability, and pharmacokinetics of crenezumabat doses of ≤120 mg/kg administered intravenously every 4 weeks (q4w). Immunogenicity and exploratory biomarkers were also evaluated.
METHODS


In this multicenter, double-blind study, participants (aged 50-90 years) with mild-to-moderate Alzheimer's disease (AD) and amyloid-positive positron emission tomography (PET) scan were randomized to receive crenezumab 30 or 45 mg/kg (Cohort 1, n = 21), 60 mg/kg (Cohort 2, n = 21), or 120 mg/kg (Cohort 3, n = 19) or corresponding placebo (n = 14) intravenously q4w for 13 weeks. Seventy-one participants were subsequently enrolled in an optional open-label extension (OLE) and received crenezumab at the originally assigned dose level, except for Cohort 3 (crenezumab 60 mg/kg during OLE). Participants received regular brain MRIs to assess amyloid-related imaging abnormalities (ARIA). Results up to Week 133 are reported.
RESULTS


Approximately 94% of participants experienced ≥1 adverse event (AE). Most AEs were mild or moderate; 15.5% experienced a Grade ≥3 AE. No ARIA-edema/effusion (ARIA-E) events were observed. New ARIA-micro hemorrhages and hemosiderosis (ARIA-H) were reported in 4.9% (double-blind treatment period) and 9.9% (combined double-blind treatment and OLE periods) of participants. Steady-state trough concentrations of crenezumab were dose-proportional and maintained for each dose level.
CONCLUSION


Crenezumab doses of ≤120 mg/kg intravenously q4w were well tolerated. The observed safety profile for ≤133 weeks of treatment in a mild-to-moderate AD population was similar to that seen in previous trials.",2020,No ARIA-edema/effusion (ARIA-E) events were observed.,"[""Patients with Mild-To-Moderate Alzheimer's Disease Treated with Escalating Doses for up to 133\xa0Weeks"", ""participants (aged 50-90 years) with mild-to-moderate Alzheimer's disease (AD) and amyloid-positive PET scan"", 'Seventy-one participants were subsequently enrolled in an optional open-label extension (OLE) and received']","['regular brain MRIs', 'crenezumab', 'placebo']","['xSafety, Tolerability, and Pharmacokinetics of Crenezumab', 'New ARIA-micro hemorrhages and hemosiderosis (ARIA-H', 'tolerated', '≥1 adverse event (AE', 'safety, tolerability, and pharmacokinetics', 'Immunogenicity and exploratory biomarkers', 'No ARIA-edema/effusion (ARIA-E) events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C3493199', 'cui_str': 'crenezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C3493199', 'cui_str': 'crenezumab'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3495884', 'cui_str': 'Amyloid related imaging abnormalities'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0019114', 'cui_str': 'Hemosiderosis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3267084', 'cui_str': 'Amyloid related imaging abnormality-oedema/effusion'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",71.0,0.439878,No ARIA-edema/effusion (ARIA-E) events were observed.,"[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Guthrie', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Honig', 'Affiliation': 'Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Kaycee M', 'Initials': 'KM', 'LastName': 'Sink', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Blondeau', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Quartino', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dolton', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Carrasco-Triguero', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Qinshu', 'Initials': 'Q', 'LastName': 'Lian', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Bittner', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Clayton', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Ostrowitzki', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200134']
1152,32449896,Peritoneal Flap in Robot-Assisted Radical Prostatectomy.,"BACKGROUND


Lymphocele is the most common complication arising after pelvic lymph node dissection (PLND) in the setting of robot-assisted radical prostatectomy (RARP). The only data available until now on the utility of a peritoneal flap to prevent lymphocele were retrospectively acquired.
METHODS


A randomized, controlled, multi-center trial with blinded assessment of endpoints was carried out on 232 patients with prostate cancer who underwent RARP with PLND. The patients in the intervention group were given a peritoneal flap; in the control group, surgery was performed without this modification. The two joint primary endpoints were the rates of symptomatic lymphocele during the same hospitalization as the operative procedure (iT1) and within 90 days of surgery (iT2). The secondary endpoints were lymphocele volume, the need for treatment of lymphocele, complications requiring an intervention, and the degree of postoperative stress incontinence. German Clinical Trials Register number: DRKS00011115.
RESULTS


The data were evaluated in an intention-to-treat analysis, which, in this trial, was identical to an as-treated analysis. 108 patients (46.6%) were allotted to the intervention group. There were no statistically significant intergroup differences with respect to any clinical or histopathological criteria. A median of 16 lymph nodes were removed (interquartile range, 11-21). A symptomatic lymphocele arose in 1.3% (iT1) and 9.1% (iT2) of the patients, without any statistically significant difference between the two trial groups (p = 0.599 and p = 0.820, respectively). Nor did the groups differ significantly with respect to lymphocele volume (p = 0.670 on hospital discharge [T1], p = 0.650 90 days after surgery [T2]) or the type and frequency of need for subsequent surgical intervention (p = 0.535; iT2). 81.5% of all patients (n = 189) had no complications at all in the first three months after surgery. Nor were there any intergroup differences at 90 days with respect to the degree of stress urinary incontinence (p = 0.306) or complications (p = 0.486).
CONCLUSION


A peritoneal flap after RARP was not found to influence the rate of postoperative lymphocele, whether asymptomatic or requiring treatment.",2020,"Nor did the groups differ significantly with respect to lymphocele volume (p = 0.670 on hospital discharge [T1], p = 0.650 90 days after surgery [T2]) or the type and frequency of need for subsequent surgical intervention (p = 0.535; iT2).","['232 patients with prostate cancer who underwent RARP with PLND', '108 patients (46.6']","['Peritoneal Flap in Robot-Assisted Radical Prostatectomy', 'peritoneal flap', 'robot-assisted radical prostatectomy (RARP']","['degree of stress urinary incontinence', 'rate of postoperative lymphocele', 'lymphocele volume, the need for treatment of lymphocele, complications requiring an intervention, and the degree of postoperative stress incontinence', 'rates of symptomatic lymphocele during the same hospitalization as the operative procedure (iT1) and within 90 days of surgery (iT2', 'lymphocele volume', 'symptomatic lymphocele', 'no complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy'}, {'cui': 'C4517530', 'cui_str': '108'}]","[{'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C1998084', 'cui_str': 'Lymphocele after surgical procedure'}, {'cui': 'C0024248', 'cui_str': 'Lymphocele'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",232.0,0.0672329,"Nor did the groups differ significantly with respect to lymphocele volume (p = 0.670 on hospital discharge [T1], p = 0.650 90 days after surgery [T2]) or the type and frequency of need for subsequent surgical intervention (p = 0.535; iT2).","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Bründl', 'Affiliation': 'Department of Urology, University of Regensburg, Caritas St. Josef Medical Center, Regensburg, Germany; Department of Urology and Andrology, Hospital of St. John of God (Krankenhaus der Barmherzigen Brüder Wien), Vienna, Austria; Department of Urology and Andrology, Paracelsus Medical University Salzburg, Salzburg, Austria; Department of Urology, St. Elisabeth Hospital Straubing, Straubing, Germany; Department of Urology, Vivantes Humboldt Hospital Berlin, Berlin Germany; These two authors are co-first authors.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Lenart', 'Affiliation': ''}, {'ForeName': 'Gjoko', 'Initials': 'G', 'LastName': 'Stojanoski', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gilfrich', 'Affiliation': ''}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Rosenhammer', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stolzlechner', 'Affiliation': ''}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Ponholzer', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dreissig', 'Affiliation': ''}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Weikert', 'Affiliation': ''}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Burger', 'Affiliation': ''}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'May', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2020.0243']
1153,32580207,Metabolic activity in subcallosal cingulate predicts response to deep brain stimulation for depression.,"Subcallosal cingulate (SCC) deep brain stimulation (DBS) is a promising therapy for treatment-resistant depression (TRD), but response rates in open-label studies were not replicated in a large multicenter trial. Identifying biomarkers of response could improve patient selection and outcomes. We examined SCC metabolic activity as both a predictor and marker of SCC DBS treatment response. Brain glucose metabolism (CMRGlu) was measured with [18F] FDG-PET at baseline and 6 months post DBS in 20 TRD patients in a double-blind randomized controlled trial where two stimulation types (long pulse width (LPW) n = 9 and short pulse width (SPW) n = 11) were used. Responders (n = 10) were defined by a ≥48% reduction in Hamilton Depression Rating Scale scores after 6 months. The response rates were similar with five responders in each stimulation group: LPW (55.6%) and SPW (44.5%). First, differences in SCC CMRGlu in responders and non-responders were compared at baseline. Then machine learning analysis was performed with a leave-one-out cross-validation using a Gaussian naive Bayes classifier to test whether baseline CMRGlu in SCC could categorize responders. Finally, we compared 6-month change in metabolic activity with change in depression severity. All analyses were controlled for age. Baseline SCC CMRGlu was significantly higher in responders than non-responders. The machine learning analysis predicted response with 80% accuracy. Furthermore, reduction in SCC CMRGlu 6 months post DBS correlated with symptom improvement (r(17) = 0.509; p = 0.031). This is the first evidence of an image-based treatment selection biomarker that predicts SCC DBS response. Future studies could utilize SCC metabolic activity for prospective patient selection.",2020,The response rates were similar with five responders in each stimulation group: LPW (55.6%) and SPW (44.5%).,['20 TRD patients'],['Subcallosal cingulate (SCC) deep brain stimulation (DBS'],"['Brain glucose metabolism (CMRGlu', 'Baseline SCC CMRGlu', 'SCC metabolic activity', 'response rates', 'metabolic activity', 'Hamilton Depression Rating Scale scores']","[{'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.0983597,The response rates were similar with five responders in each stimulation group: LPW (55.6%) and SPW (44.5%).,"[{'ForeName': 'Elliot C', 'Initials': 'EC', 'LastName': 'Brown', 'Affiliation': 'Mathison Centre for Mental Health Research & Education, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Darren L', 'Initials': 'DL', 'LastName': 'Clark', 'Affiliation': 'Mathison Centre for Mental Health Research & Education, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Nils D', 'Initials': 'ND', 'LastName': 'Forkert', 'Affiliation': 'Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Molnar', 'Affiliation': 'Department of Radiology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Zelma H T', 'Initials': 'ZHT', 'LastName': 'Kiss', 'Affiliation': 'Mathison Centre for Mental Health Research & Education, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Rajamannar', 'Initials': 'R', 'LastName': 'Ramasubbu', 'Affiliation': 'Mathison Centre for Mental Health Research & Education, University of Calgary, Calgary, AB, Canada. rramasub@ucalgary.ca.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0745-5']
1154,32457078,"Efficacy of maternal B 12  supplementation in vegetarian women for improving infant neurodevelopment: protocol for the MATCOBIND multicentre, double-blind, randomised controlled trial.","INTRODUCTION


Vitamin B 12  deficiency is widely prevalent across many low- and middle-income countries, especially where the diet is low in animal sources. While many observational studies show associations between B 12  deficiency in pregnancy and infant cognitive function (including memory, language and motor skills), evidence from clinical trials is sparse and inconclusive.
METHODS AND ANALYSIS


This double-blind, multicentre, randomised controlled trial will enrol 720 vegetarian pregnant women in their first trimester from antenatal clinics at two hospitals (one in India and one in Nepal). Eligible mothers who give written consent will be randomised to receive either 250 mcg methylcobalamin or 50 mcg (quasi control), from enrolment to 6 months post-partum, given as an oral daily capsule. All mothers and their infants will continue to receive standard clinical care. The primary trial outcome is the offspring's neurodevelopment status at 9 months of age, assessed using the Development Assessment Scale of Indian Infants. Secondary outcomes include the infant's biochemical B 12  status at age 9 months and maternal biochemical B 12  status in the first and third trimesters. Maternal biochemical B 12  status will also be assessed in the first trimester. Modification of association by a priori identified factors will also be explored.
ETHICAL CONSIDERATIONS AND DISSEMINATION


The study protocol has been approved by ethical committees at each study site (India and Nepal) and at University College London, UK. The study results will be disseminated to healthcare professionals and academics globally via conferences, presentations and publications. Researchers at each study site will share results with participants during their follow-up visits. Trial registration number CTRI/2018/07/015048 (Clinical Trial Registry of India); NCT04083560 (ClinicalTrials.gov).",2020,"This double-blind, multicentre, randomised controlled trial will enrol 720 vegetarian pregnant women in their first trimester from antenatal clinics at two hospitals (one in India and one in Nepal).","['Eligible mothers who give written consent', '720 vegetarian pregnant women in their first trimester from antenatal clinics at two hospitals (one in India and one in Nepal', 'vegetarian women for improving infant neurodevelopment']","['250 mcg methylcobalamin', 'maternal B 12  supplementation']","[""offspring's neurodevelopment status at 9 months of age, assessed using the Development Assessment Scale of Indian Infants"", ""infant's biochemical B 12  status at age 9 months and maternal biochemical B 12  status in the first and third trimesters""]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C4517865', 'cui_str': '720'}, {'cui': 'C0042441', 'cui_str': 'Vegetarian'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0065844', 'cui_str': 'mecobalamin'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}]",720.0,0.478247,"This double-blind, multicentre, randomised controlled trial will enrol 720 vegetarian pregnant women in their first trimester from antenatal clinics at two hospitals (one in India and one in Nepal).","[{'ForeName': 'Jitender', 'Initials': 'J', 'LastName': 'Nagpal', 'Affiliation': 'Pediatrics, Sitaram Bhartia Institute of Science and Research, New Delhi, Delhi, India.'}, {'ForeName': 'Manu Raj', 'Initials': 'MR', 'LastName': 'Mathur', 'Affiliation': 'Public Health Foundation of India, New Delhi, India.'}, {'ForeName': 'Swapnil', 'Initials': 'S', 'LastName': 'Rawat', 'Affiliation': 'Pediatrics, Sitaram Bhartia Institute of Science and Research, New Delhi, Delhi, India.'}, {'ForeName': 'Deepti', 'Initials': 'D', 'LastName': 'Nagrath', 'Affiliation': 'Public Health Foundation of India, New Delhi, India.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'UCL GOS Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Singhal', 'Affiliation': 'UCL GOS Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Heys', 'Affiliation': 'UCL GOS Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Cortina Borja', 'Affiliation': 'UCL GOS Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Augustin', 'Affiliation': 'UCL GOS Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Jageshwor', 'Initials': 'J', 'LastName': 'Gautam', 'Affiliation': ""Obstetrics and Gynaecology, Paropakar Maternity & Women's Hospital, Kathmandu, Nepal.""}, {'ForeName': 'Rajendra', 'Initials': 'R', 'LastName': 'Pant', 'Affiliation': ""Obstetrics and Gynaecology, Paropakar Maternity & Women's Hospital, Kathmandu, Nepal.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Swabey', 'Affiliation': 'UCL GOS Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Lakhanpaul', 'Affiliation': 'UCL GOS Institute of Child Health, University College London, London, UK m.lakhanpaul@ucl.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-034987']
1155,32457082,"Enhanced PeriOperative Care and Health protection programme for the prevention of surgical site infections after elective abdominal surgery (EPOCH): study protocol of a randomised controlled, multicentre, superiority trial.","INTRODUCTION


Surgical site infections (SSI) are a common postoperative complication. During the development of the new WHO guidelines on SSI prevention, also in the Netherlands was concluded that perioperative care could be optimised beyond the current standard practice. We selected a limited set of readily available, cheap and evidence-based interventions from these new guidelines that are not part of standard practice in the Netherlands and formulated an Enhanced PeriOperative Care and Health bundle (EPOCH). Here, we describe the protocol for an open-label, randomised controlled, parallel-group, superiority trial to test the effect of the EPOCH bundle added to (national) standard care in comparison to standard care alone on the incidence of SSI.
METHODS AND ANALYSIS


EPOCH consists of intraoperative high fractional inspired oxygen (0.80); goal-directed fluid therapy; active preoperative, intraoperative and postoperative warming; perioperative glucose control and treatment of severe hyperglycaemia (>10 mmol l-1 ) and standardised surgical site handling. Patients scheduled for elective abdominal surgery with an incision larger than 5 cm are eligible for inclusion. Participants are randomised daily, 1:1 according to variable block sizes, and stratified per participating centre to either EPOCH added to standard care or standard care only. The primary endpoint will be SSI incidence according to the Centers for Disease Control and Prevention (CDC) definition within 30 days as part of routine clinical follow-up. Four additional questionnaires will be sent out over the course of 90 days to capture disability and costs. Other secondary endpoints include anastomotic leakage, incidence of incisional hernia, serious adverse events, hospital readmissions, length of stay and cost effectiveness. Analysis of the primary endpoint will be on an intention-to-treat basis.
ETHICS AND DISSEMINATION


Ethics approval is granted by the Amsterdam UMC Medical Ethics Committee (reference 2015_121). Results will be disseminated through peer-reviewed journals and summaries shared with stakeholders. This protocol is published before analysis of the results.
TRIAL REGISTRATION NUMBER


Registered in the Dutch Trial Register: NL5572.",2020,"Other secondary endpoints include anastomotic leakage, incidence of incisional hernia, serious adverse events, hospital readmissions, length of stay and cost effectiveness.","['severe hyperglycaemia (>10 mmol l-1 ) and standardised surgical site handling', 'Patients scheduled for elective abdominal surgery with an incision larger than 5 cm are eligible for inclusion', 'surgical site infections after elective abdominal surgery (EPOCH']","['EPOCH bundle added to (national) standard care', 'intraoperative high fractional inspired oxygen (0.80); goal-directed fluid therapy; active preoperative, intraoperative and postoperative warming; perioperative glucose control', 'EPOCH added to standard care or standard care only']","['SSI incidence according to the Centers for Disease Control and Prevention (CDC) definition within 30 days as part of routine clinical follow-up', 'anastomotic leakage, incidence of incisional hernia, serious adverse events, hospital readmissions, length of stay and cost effectiveness', 'intention-to-treat basis']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0600472', 'cui_str': 'L1 Elements'}, {'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0150706', 'cui_str': 'Perioperative care'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0150706', 'cui_str': 'Perioperative care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",,0.182783,"Other secondary endpoints include anastomotic leakage, incidence of incisional hernia, serious adverse events, hospital readmissions, length of stay and cost effectiveness.","[{'ForeName': 'Stijn W', 'Initials': 'SW', 'LastName': 'de Jonge', 'Affiliation': 'Department of Surgery, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Wolfhagen', 'Affiliation': 'Department of Surgery, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands.'}, {'ForeName': 'Quirine Jj', 'Initials': 'QJ', 'LastName': 'Boldingh', 'Affiliation': 'Department of Surgery, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands.'}, {'ForeName': 'Wouter J', 'Initials': 'WJ', 'LastName': 'Bom', 'Affiliation': 'Department of Surgery, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Posthuma', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands.'}, {'ForeName': 'Jochem Cg', 'Initials': 'JC', 'LastName': 'Scheijmans', 'Affiliation': 'Department of Surgery, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands.'}, {'ForeName': 'Bart Mf', 'Initials': 'BM', 'LastName': 'van der Leeuw', 'Affiliation': 'Department of Anesthesiology, Albert Schweitzer Hospital, Dordrecht, Noord-Holland, Netherlands.'}, {'ForeName': 'Joost Ab', 'Initials': 'JA', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Surgery, Albert Schweitzer Hospital, Dordrecht, Zuid-Holland, Netherlands.'}, {'ForeName': 'Jens Peter', 'Initials': 'JP', 'LastName': 'Hering', 'Affiliation': 'Anesthesiology, Dijklander Ziekenhuis, Hoorn, Noord-Holland, Netherlands.'}, {'ForeName': 'Dirk Ja', 'Initials': 'DJ', 'LastName': 'Sonneveld', 'Affiliation': 'Department of Surgery, Dijklander Ziekenhuis, Hoorn, Noord-Holland, Netherlands.'}, {'ForeName': 'Otto E', 'Initials': 'OE', 'LastName': 'van Geffen', 'Affiliation': 'Department of Anesthesiology, Tergooiziekenhuizen, Hilversum, Noord-Holland, Netherlands.'}, {'ForeName': 'Eduard R', 'Initials': 'ER', 'LastName': 'Hendriks', 'Affiliation': 'Department of Surgery, Tergooiziekenhuizen, Hilversum, Noord-Holland, Netherlands.'}, {'ForeName': 'Ewoud B', 'Initials': 'EB', 'LastName': 'Kluyver', 'Affiliation': 'Department of Anesthesiology, Rode Kruis Ziekenhuis, Beverwijk, Noord-Holland, Netherlands.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Demirkiran', 'Affiliation': 'Department of Surgery, Rode Kruis Ziekenhuis, Beverwijk, Noord-Holland, Netherlands.'}, {'ForeName': 'Luc Rcw', 'Initials': 'LR', 'LastName': 'van Lonkhuijzen', 'Affiliation': 'Department of Gynaecologic Oncology, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Slotema', 'Affiliation': ""Department of Anesthesiology, Jeroen Bosch Hospital, 's-Hertogenbosch, Noord-Brabant, Netherlands.""}, {'ForeName': 'Werner A', 'Initials': 'WA', 'LastName': 'Draaisma', 'Affiliation': ""Department of Surgery, Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, Noord-Brabant, Netherlands.""}, {'ForeName': 'Seppe Jsha', 'Initials': 'SJ', 'LastName': 'Koopman', 'Affiliation': 'Department of Anesthesiology, Maasstad Ziekenhuis, Rotterdam, Zuid-Holland, Netherlands.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'van Rossem', 'Affiliation': 'Department of Surgery, Maasstad Ziekenhuis, Rotterdam, Zuid-Holland, Netherlands.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Over', 'Affiliation': 'Department of Anesthesiology, Gelre Ziekenhuizen, Apeldoorn, Gelderland, Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'van Duijvendijk', 'Affiliation': 'Department of Surgery, Gelre Ziekenhuizen, Apeldoorn, Gelderland, Netherlands.'}, {'ForeName': 'Marcel Gw', 'Initials': 'MG', 'LastName': 'Dijkgraaf', 'Affiliation': 'Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Hollmann', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands.'}, {'ForeName': 'Marja A', 'Initials': 'MA', 'LastName': 'Boermeester', 'Affiliation': 'Department of Surgery, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands m.a.boermeester@amsterdamumc.nl.'}]",BMJ open,['10.1136/bmjopen-2020-038196']
1156,32457083,"Faecal microbiota transplant to ERadicate gastrointestinal carriage of Antibiotic Resistant Organisms (FERARO): a prospective, randomised placebo-controlled feasibility trial.","INTRODUCTION


Antimicrobial resistance is rising, largely due to the indiscriminate use of antimicrobials. The human gut is the largest reservoir of antibiotic resistant bacteria (ARB). Individuals colonised with ARB have the potential to spread these organisms both in the community and hospital settings. Infections with ARB such as extended spectrum beta-lactamase producing enterobacteriales (ESBL-E) and carbapenemase producing enterobacteriales (CPE) are more difficult to treat and are associated with an increased morbidity and mortality. Presently, there is no effective decolonisation strategy for these ARB. Faecal microbiota transplant (FMT) has emerged as a potential strategy for decolonisation of ARB from the human gut, however there is significant uncertainty about the feasibility, effectiveness and safety of using this approach.
METHODS AND ANALYSIS


Prospective, randomised, patient-blinded, placebo-controlled feasibility trial of FMT to eradicate gastrointestinal carriage of ARB. Eighty patients with a recent history of invasive infection secondary to ESBL-E or CPE and persistent gastrointestinal carriage will be randomised 1:1 to receive encapsulated FMT or placebo. The primary outcome measure is consent rate (as a proportion of patients who fulfil inclusion/exclusion criteria); this will be used to determine if a substantive trial is feasible. Participants will be followed up at 1 week, 1 month, 3 months and 6 months and monitored for adverse events as well as gastrointestinal carriage rates of ARB after intervention.
ETHICS AND DISSEMINATION


Research ethics approval was obtained by London-City and East Research Ethics Committee (ref 20/LO/0117). Trial results will be published in a peer-reviewed journal and presented at international conferences.
TRIAL REGISTRATION NUMBER


ISRCTN registration number 34 467 677 and EudraCT number 2019-001618-41.",2020,"Faecal microbiota transplant (FMT) has emerged as a potential strategy for decolonisation of ARB from the human gut, however there is significant uncertainty about the feasibility, effectiveness and safety of using this approach.
","['number 34\u2009467', 'Eighty patients with a recent history of invasive infection secondary to ESBL-E or CPE and persistent gastrointestinal carriage', 'Faecal microbiota transplant (FMT', 'Faecal microbiota transplant to ERadicate gastrointestinal carriage of Antibiotic Resistant Organisms (FERARO']","['encapsulated FMT or placebo', 'FMT', 'placebo']","['consent rate', 'gastrointestinal carriage rates of ARB']","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4517784', 'cui_str': '467'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0442886', 'cui_str': 'Secondary infection'}, {'cui': 'C0486433', 'cui_str': 'Extended-spectrum beta lactamase'}, {'cui': 'C1040967', 'cui_str': 'Order Enterobacterales'}, {'cui': 'C0246081', 'cui_str': 'carbapenemase'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0029235', 'cui_str': 'Organism'}]","[{'cui': 'C0205223', 'cui_str': 'Encapsulated'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1444090', 'cui_str': 'Resistant bacteria'}]",80.0,0.359758,"Faecal microbiota transplant (FMT) has emerged as a potential strategy for decolonisation of ARB from the human gut, however there is significant uncertainty about the feasibility, effectiveness and safety of using this approach.
","[{'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Merrick', 'Affiliation': ""Centre for Clinical Infection and Diagnostics Research, Guy's and Saint Thomas' Hospitals NHS Trust, London, UK.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Robinson', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'Catey', 'Initials': 'C', 'LastName': 'Bunce', 'Affiliation': ""Primary Care and Public Health Sciences, King's College London, London, UK.""}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Allen', 'Affiliation': ""Pharmacy Department, Guy's and Saint Thomas' Hospitals NHS Trust, London, UK.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Bisnauthsing', 'Affiliation': ""Centre for Clinical Infection and Diagnostics Research, Guy's and Saint Thomas' Hospitals NHS Trust, London, UK.""}, {'ForeName': 'Chi Chi', 'Initials': 'CC', 'LastName': 'Izundu', 'Affiliation': ""Care of Guy's and Saint Thomas' NHS Trust, London, UK.""}, {'ForeName': 'Jordana', 'Initials': 'J', 'LastName': 'Bell', 'Affiliation': ""Department of Twin Research and Genetic Epidemiology, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Amos', 'Affiliation': 'National Institute for Biological Standards and Control, Potters Bar, UK.'}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Shankar-Hari', 'Affiliation': ""Department of Infectious Diseases, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Goodman', 'Affiliation': ""Centre for Clinical Infection and Diagnostics Research, Guy's and Saint Thomas' Hospitals NHS Trust, London, UK.""}, {'ForeName': 'Debbie L', 'Initials': 'DL', 'LastName': 'Shawcross', 'Affiliation': ""Institute of Liver Studies, Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Goldenberg', 'Affiliation': ""Centre for Clinical Infection and Diagnostics Research, Guy's and Saint Thomas' Hospitals NHS Trust, London, UK Simon.Goldenberg@gstt.nhs.uk.""}]",BMJ open,['10.1136/bmjopen-2020-038847']
1157,32457106,Open-Label Crossover Oral Bioequivalence Pharmacokinetics Comparison for a 3-Day Loading Dose Regimen and 15-Day Steady-State Administration of SUBA-Itraconazole and Conventional Itraconazole Capsules in Healthy Adults.,"Super bioavailability (SUBA) itraconazole (S-ITZ), which releases drug in the duodenum, and conventional itraconazole (C-ITZ), which releases drug in the stomach, were compared in two pharmacokinetic (PK) studies: a 3-day loading dose study and a 15-day steady-state administration study. These were crossover oral bioequivalence studies performed under fed conditions in healthy adult volunteers. In the loading dose study, C-ITZ (two doses of 100 mg each) and S-ITZ (two doses of 65 mg each) were administered three times daily for 3 days and once on day 4 ( n  = 15). For the steady-state administration study, C-ITZ (two doses of 100 mg each) and S-ITZ (two doses of 65 mg each) were administered twice daily for 14 days and a last dose was administered 30 min after a meal on day 15 ( n  = 16). Blood samples collected throughout both studies were analyzed for ITZ and hydroxy-ITZ (OH-ITZ) levels. Least-squares geometric means were used to compare the maximum peak concentration of drug after administration at steady state prior to administration of the subsequent dose ( C   max_ss ), the minimum drug level after administration prior to the subsequent dose ( C   trough ), and the area under the curve over the dosing interval (AUC tau ) of each formulation. The ratios of itraconazole (ITZ) and OH-ITZ for S-ITZ to C-ITZ were between 107% and 118% in both studies for  C   max_ss ,  C   trough , and AUC tau , which were within the U.S. FDA-required bioequivalence range of 80% to 125%. At the end of the steady-state administration study, 13 of 16 volunteers obtained higher mean ITZ blood  C   trough  levels of >1,000 ng/ml when they were administered S-ITZ (81%) than when they were administered C-ITZ (44%). The study drugs were well tolerated in both studies, with similar adverse events (AEs). All treatment-emergent AEs resolved after study completion. One volunteer receiving C-ITZ discontinued due to a treatment-unrelated AE in the steady-state administration study. No serious AEs were reported. Total, trough, and peak ITZ and OH-ITZ exposures were similar between the two formulations. Therefore, SUBA-ITZ, which has 35% less drug than C-ITZ, was bioequivalent to C-ITZ in healthy adult volunteers and exhibited a safety profile similar to that of C-ITZ.",2020,"Total, trough and peak ITZ and OH-ITZ exposure were similar between formulations.","['healthy adult volunteers', 'Healthy Adults']","['SUBA™-Itraconazole and Conventional Itraconazole Capsules', 'C-ITZ (2x100 mg) and S-ITZ', 'conventional ITZ (C-ITZ', 'SUBA™-itraconazole']","['mean C trough  ITZ blood levels ', 'Total, trough and peak ITZ and OH-ITZ exposure', 'Ratios of ITZ and OH-ITZ for S-ITZ to C-ITZ']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1244751', 'cui_str': 'Itraconazole Oral Capsule'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]",,0.0196089,"Total, trough and peak ITZ and OH-ITZ exposure were similar between formulations.","[{'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Thompson', 'Affiliation': 'UC Davis School of Medicine, Department of Internal Medicine, Division of Infectious Diseases, Sacramento, California, USA.'}, {'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'Lewis', 'Affiliation': 'Department of Medical Affairs, Mayne Pharma, Inc., Raleigh, North Carolina, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Mudge', 'Affiliation': 'Department of Medical Affairs, Mayne Pharma, LLC, Melbourne, Australia.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Patterson', 'Affiliation': 'University of Texas Health Science Center, Division of Infectious Diseases, San Antonio, Texas, USA.'}, {'ForeName': 'Bruce P', 'Initials': 'BP', 'LastName': 'Burnett', 'Affiliation': 'Department of Medical Affairs, Mayne Pharma, Inc., Raleigh, North Carolina, USA bruce.burnett@maynepharma.com.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00400-20']
1158,32462740,Vitamin D supplementation for sickle cell disease.,"BACKGROUND


Sickle cell disease (SCD) is a genetic chronic haemolytic and pro-inflammatory disorder. With increased catabolism and deficits in energy and nutrient intake, individuals with SCD suffer multiple macro- and micro-nutritional deficiencies, including vitamin D deficiency. This is an update of a previous review.
OBJECTIVES


To investigate the effects of vitamin D supplementation in children and adults with SCD and to compare different dose regimens. To determine the effects of vitamin D supplementation on general health (e.g. growth status and health-related quality of life), on musculoskeletal health (including bone mineral density, pain crises, bone fracture and muscle health), on respiratory health (including lung function, acute chest syndrome, acute exacerbation of asthma and respiratory infections) and the safety of vitamin D supplementation.
SEARCH METHODS


We searched the Cochrane Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. Date of last search: 19 March 2020. We also searched database such as PubMed, clinical trial registries and the reference lists of relevant articles and reviews. Date of last search: 14 January 2020.
SELECTION CRITERIA


Randomised controlled trials (RCTs) and quasi-RCTs comparing oral administration of any form of vitamin D supplementation at any dose and for any duration to another type or dose of vitamin D or placebo or no supplementation in people with SCD, of all ages, gender, and phenotypes.
DATA COLLECTION AND ANALYSIS


Two authors independently extracted the data and assessed the risk of bias of the included studies. They used the GRADE guidelines to assess the quality of the evidence.
MAIN RESULTS


Vitamin D versus placebo One double-blind RCT (n = 39) compared oral vitamin D3 (cholecalciferol) supplementation (20 participants) to placebo (19 participants) for six weeks. Only 25 participants completed the full six months of follow-up. The study had a high risk of bias due to incomplete outcome data, but a low risk of bias for randomisation, allocation concealment, blinding (of participants, personnel and outcome assessors) and selective outcome reporting; and an unclear risk of other biases. Vitamin D supplementation probably led to higher serum 25(OH)D levels at eight weeks, mean difference (MD) 29.79 (95% confidence interval (CI) 26.63 to 32.95); at 16 weeks, MD 12.67 (95% CI 10.43 to 14.90); and at 24 weeks, MD 15.52 (95% CI 13.50 to 17.54) (moderate-quality evidence). There was little or no difference in adverse events (tingling of lips or hands) between the vitamin D and placebo groups, risk ratio 3.16 (95% CI 0.14 to 72.84) (low-quality evidence). Vitamin D supplementation probably caused fewer pain days compared to the placebo group at eight weeks, MD -10.00 (95% CI -16.47 to -3.53) (low-quality evidence), but probably led to a lower (worse) health-related quality of life score (change from baseline in physical functioning PedsQL scores); at both 16 weeks, MD -12.56 (95% CI -16.44 to -8.69) and 24 weeks, MD -12.59 (95% CI -17.43 to -7.76), although this may not be the case at eight weeks (low-quality evidence). Vitamin D supplementation regimens compared Two double-blind RCTs (83 participants) compared different regimens of vitamin D. One RCT (n = 62) compared oral vitamin D3 7000 IU/day to 4000 IU/day for 12 weeks, while the second RCT (n = 21) compared oral vitamin D3 100,000 IU/month to 12,000 IU/month for 24 months. Both RCTs had low risk of bias for blinding (of participants, personnel and outcome assessors) and incomplete outcome data, but the risk of selective outcome reporting bias was high. The bias from randomisation and allocation concealment was low in one study but not in the second. There was an unclear risk of other biases. When comparing oral vitamin D 100,000 IU/month to 12,000 IU/month, the higher dose may have resulted in higher serum 25(OH)D levels at one year, MD 16.40 (95% CI 12.59 to 20.21) and at two years, MD 18.96 (95% CI 15.20 to 22.72) (low-quality evidence). There was little or no difference in adverse events between doses (low-quality evidence). There were more episodes of acute chest syndrome in the high-dose group, at one year, MD 0.27 (95% CI 0.02 to 0.52) but there was little or no difference at two years, MD 0.09 (95% CI -0.04 to 0.22) (moderate-quality evidence). At one year and two years there was also little or no difference between the doses in the presence of pain (moderate-quality evidence) or forced expiratory volume in one second % predicted. However, the high-dose group had lower values for % predicted forced vital capacity at both one and two years, MD -7.20% predicted (95% CI -14.15 to -0.25) and MD -7.10% predicted (95% CI -14.03 to -0.17), respectively. There were little or no differences between dose regimens in the muscle health of either hand or the dominant hand. The study comparing oral vitamin D3 7000 IU/day to 4000 IU/day (21 participants) did not provide data for analysis, but median serum 25(OH)D levels were reported to be lower in the low-dose group at both six and 12 weeks. At 12 weeks the median serum parathyroid hormone level was lower in the high-dose group.
AUTHORS' CONCLUSIONS


We included three RCTs of varying quality. We consider that the current evidence presented in this review is not of sufficient quality to guide clinical practice. Until further evidence becomes available, clinicians should consider the relevant existing guidelines for vitamin D supplementation and dietary reference intakes for calcium and vitamin D. Well-designed RCTs of parallel design, are required to determine the effects and the safety of vitamin D supplementation as well as to assess the relative benefits of different doses in children and adults with SCD.",2020,"There was little or no difference in adverse events (tingling of lips or hands) between the vitamin D and placebo groups, risk ratio 3.16 (95% CI 0.14 to 72.84) (low-quality evidence).","['sickle cell disease', 'children and adults with SCD', 'people with SCD, of all ages, gender, and phenotypes']","['vitamin D. One RCT', 'vitamin D or placebo or no supplementation', 'Vitamin D supplementation', 'oral vitamin D3', 'vitamin D supplementation', 'oral vitamin D3 (cholecalciferol) supplementation', 'placebo']","['general health (e.g. growth status and health-related quality of life', 'musculoskeletal health (including bone mineral density, pain crises, bone fracture and muscle health), on respiratory health (including lung function, acute chest syndrome, acute exacerbation of asthma and respiratory infections', 'forced vital capacity', 'pain days', 'episodes of acute chest syndrome', 'presence of pain (moderate-quality evidence) or forced expiratory volume', 'adverse events (tingling of lips or hands', 'lower (worse) health-related quality of life score', 'adverse events', 'median serum parathyroid hormone level', 'median serum 25(OH)D levels', 'serum 25(OH)D levels']","[{'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}]","[{'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0231225', 'cui_str': 'Pain crisis'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0742343', 'cui_str': 'Acute chest syndrome'}, {'cui': 'C0347950', 'cui_str': 'Acute exacerbation of asthma'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0877487', 'cui_str': 'Tingling lips'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0428408', 'cui_str': 'Serum parathyroid hormone measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.658415,"There was little or no difference in adverse events (tingling of lips or hands) between the vitamin D and placebo groups, risk ratio 3.16 (95% CI 0.14 to 72.84) (low-quality evidence).","[{'ForeName': 'Htoo Htoo Kyaw', 'Initials': 'HHK', 'LastName': 'Soe', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Melaka-Manipal Medical College, Manipal Academy of Higher Education (MAHE), Melaka, Malaysia.'}, {'ForeName': 'Adinegara Bl', 'Initials': 'AB', 'LastName': 'Abas', 'Affiliation': 'Department of Community Medicine, Melaka-Manipal Medical College (Manipal Academy of Higher Education), Melaka, Malaysia.'}, {'ForeName': 'Nan Nitra', 'Initials': 'NN', 'LastName': 'Than', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Melaka-Manipal Medical College (MMMC), Manipal Academy of Higher Education(MAHE), Melaka, Malaysia.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Ni', 'Affiliation': 'Faculty of Medicine, SEGi University, Sibu, Malaysia.'}, {'ForeName': 'Jaspal', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Faculty of Medicine, Melaka-Manipal Medical College, Melaka, Malaysia.'}, {'ForeName': 'Abdul Razzak Bin Mohd', 'Initials': 'ARBM', 'LastName': 'Said', 'Affiliation': 'Melaka-Manipal Medical College, Melaka, Malaysia.'}, {'ForeName': 'Ifeyinwa', 'Initials': 'I', 'LastName': 'Osunkwo', 'Affiliation': 'Comprehensive Sickle Cell Program, Aflac Cancer and Blood Disorders Service, Emory University School of Medicine, Atlanta, Georgia, USA.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD010858.pub3']
1159,32459651,A Wearable Technology Delivering a Web-Based Diabetes Prevention Program to People at High Risk of Type 2 Diabetes: Randomized Controlled Trial.,"BACKGROUND


Intensive lifestyle interventions are effective in reducing the risk of type 2 diabetes, but the implementation of learnings from landmark studies is expensive and time consuming. The availability of digital lifestyle interventions is increasing, but evidence of their effectiveness is limited.
OBJECTIVE


This randomized controlled trial (RCT) aimed to test the feasibility of a web-based diabetes prevention program (DPP) with step-dependent feedback messages versus a standard web-based DPP in people with prediabetes.
METHODS


We employed a two-arm, parallel, single-blind RCT for people at high risk of developing diabetes. Patients with a hemoglobin A 1c  (HbA 1c ) level of 39-47 mmol/mol were recruited from 21 general practices in London. The intervention integrated a smartphone app delivering a web-based DPP course with SMS texts incorporating motivational interviewing techniques and step-dependent feedback messages delivered via a wearable device over 12 months. The control group received the wearable technology and access to the web-based DDP but not the SMS texts. As this was a feasibility study, the primary aim was to estimate potential sample size at different stages of the study, including the size of the target study population and the proportion of participants who consented, were randomized, and completed follow-up. We also measured the main outcomes for a full-scale RCT, namely, change in weight and physical activity at 6- and 12-month follow-ups, and secondary outcomes, including changes in the HbA 1c  level, blood pressure, waist circumference, waist-to-hip ratio, and lipid levels.
RESULTS


We enrolled 200 participants: 98 were randomized to the intervention and 102 were randomized to the control group. The follow-up rate was higher in the control group (87/102, 85.3%) than in the intervention group (69/98, 70%) at 12 months. There was no treatment effect on weight at 6 months (mean difference 0.15; 95% CI -0.93 to 1.23) or 12 months (mean difference 0.07 kg; 95% CI -1.29 to 1.44) or for physical activity levels at 6 months (mean difference -382.90 steps; 95% CI -860.65 to 94.85) or 12 months (mean difference 92.64 steps; 95% CI -380.92 to 566.20). We did not observe a treatment effect on the secondary outcomes measured at the 6-month or 12-month follow-up. For the intervention group, the mean weight was 92.33 (SD 15.67) kg at baseline, 91.34 (SD 16.04) kg at 6 months, and 89.41 (SD 14.93) kg at 12 months. For the control group, the mean weight was 92.59 (SD 17.43) kg at baseline, 91.71 (SD 16.48) kg at 6 months, and 91.10 (SD 15.82) kg at 12 months. In the intervention group, the mean physical activity was 7308.40 (SD 4911.93) steps at baseline, 5008.76 (SD 2733.22) steps at 6 months, and 4814.66 (SD 3419.65) steps at 12 months. In the control group, the mean physical activity was 7599.28 (SD 3881.04) steps at baseline, 6148.83 (SD 3433.77) steps at 6 months, and 5006.30 (SD 3681.1) steps at 12 months.
CONCLUSIONS


This study demonstrates that it is feasible to successfully recruit and retain patients in an RCT of a web-based DPP.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02919397; http://clinicaltrials.gov/ct2/show/NCT02919397.",2020,We did not observe a treatment effect on the secondary outcomes measured at 6-month or 12-month follow-up.,"['people with pre-diabetes', 'People at High Risk of Type 2 Diabetes', 'We enrolled 200 participants: 98', 'people at high risk of developing diabetes', 'Patients with a hemoglobin A1c (HbA1c) level of 39-47 mmol/mol were recruited from 21 general practices in London']","['smartphone app delivering a web-based DPP course with SMS texts incorporating motivational interviewing techniques and step-dependent feedback messages delivered via a wearable device over 12 months', 'Wearable Technology Delivering a Web-Based Diabetes Prevention Program', 'web-based diabetes prevention program (DPP) with step-dependent feedback messages versus a standard web-based DPP']","['weight', 'PA levels', 'change in HbA1c, blood pressure, waist circumference, waist-to-hip ratio, and lipid levels', 'full-scale RCT, namely, change in weight and physical activity (PA']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0023973', 'cui_str': 'London'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C4076391', 'cui_str': 'Motivational interviewing technique'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",200.0,0.204808,We did not observe a treatment effect on the secondary outcomes measured at 6-month or 12-month follow-up.,"[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Staite', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bayley', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Ebaa', 'Initials': 'E', 'LastName': 'Al-Ozairi', 'Affiliation': 'Faculty of Medicine, Department of Medicine & Dasman Diabetes Institute, Kuwait University, Al Kuwayt, Kuwait.'}, {'ForeName': 'Kurtis', 'Initials': 'K', 'LastName': 'Stewart', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, United Kingdom.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hopkins', 'Affiliation': ""King's College Hospital NHS Foundation Trust, King's Health Partners, London, United Kingdom.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rundle', 'Affiliation': ""South Thames Cleft Service, St Thomas' Hospital, London, United Kingdom.""}, {'ForeName': 'Neel', 'Initials': 'N', 'LastName': 'Basudev', 'Affiliation': 'Health Innovation Network, London, United Kingdom.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mohamedali', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Khalida', 'Initials': 'K', 'LastName': 'Ismail', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, United Kingdom.""}]",JMIR mHealth and uHealth,['10.2196/15448']
1160,32544925,Selective kappa-opioid antagonism ameliorates anhedonic behavior: evidence from the Fast-fail Trial in Mood and Anxiety Spectrum Disorders (FAST-MAS).,"Anhedonia remains a major clinical issue for which there is few effective interventions. Untreated or poorly controlled anhedonia has been linked to worse disease course and increased suicidal behavior across disorders. Taking a proof-of-mechanism approach under the auspices of the National Institute of Mental Health FAST-FAIL initiative, we were the first to show that, in a transdiagnostic sample screened for elevated self-reported anhedonia, 8 weeks of treatment with a kappa-opioid receptor (KOR) antagonist resulted in significantly higher reward-related activation in one of the core hubs of the brain reward system (the ventral striatum), better reward learning in the Probabilistic Reward Task (PRT), and lower anhedonic symptoms, relative to 8 weeks of placebo. Here, we performed secondary analyses of the PRT data to investigate the putative effects of KOR antagonism on anhedonic behavior with more precision by using trial-level model-based Bayesian computational modeling and probability analyses. We found that, relative to placebo, KOR antagonism resulted in significantly higher learning rate (i.e., ability to learn from reward feedback) and a more sustained preference toward the more frequently rewarded stimulus, but unaltered reward sensitivity (i.e., the hedonic response to reward feedback). Collectively, these findings provide novel evidence that in a transdiagnostic sample characterized by elevated anhedonia, KOR antagonism improved the ability to modulate behavior as a function of prior rewards. Together with confirmation of target engagement in the primary report (Krystal et al., Nat Med, 2020), the current findings suggest that further transdiagnostic investigation of KOR antagonism for anhedonia is warranted.",2020,"We found that, relative to placebo, KOR antagonism resulted in significantly higher learning rate (i.e., ability to learn from reward feedback) and a more sustained preference toward the more frequently rewarded stimulus, but unaltered reward sensitivity (i.e., the hedonic response to reward feedback).",[],"['placebo, KOR antagonism', 'KOR antagonism', 'placebo']","['learning rate (i.e., ability to learn from reward feedback']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0064239', 'cui_str': 'kappa Opioid Receptor'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0233832', 'cui_str': 'Learning ability'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",,0.0633681,"We found that, relative to placebo, KOR antagonism resulted in significantly higher learning rate (i.e., ability to learn from reward feedback) and a more sustained preference toward the more frequently rewarded stimulus, but unaltered reward sensitivity (i.e., the hedonic response to reward feedback).","[{'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'McLean Hospital, Harvard Medical School, Belmont, MA, USA. dap@mclean.harvard.edu.'}, {'ForeName': 'Moria', 'Initials': 'M', 'LastName': 'Smoski', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Yuen-Siang', 'Initials': 'YS', 'LastName': 'Ang', 'Affiliation': 'McLean Hospital, Harvard Medical School, Belmont, MA, USA.'}, {'ForeName': 'Alexis E', 'Initials': 'AE', 'LastName': 'Whitton', 'Affiliation': 'School of Medical Sciences, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Sanjay J', 'Initials': 'SJ', 'LastName': 'Mathew', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nurnberger', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Lisanby', 'Affiliation': 'National Institute of Mental Health, Bethesda, MD, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Murrough', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Hongqiu', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Weiner', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': 'Case Western Reserve School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Goodman', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'William Z', 'Initials': 'WZ', 'LastName': 'Potter', 'Affiliation': 'National Institute of Mental Health, Bethesda, MD, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Krystal', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0738-4']
1161,32558709,Pitfalls in the Detection of Insulinomas With Glucagon-Like Peptide-1 Receptor Imaging.,"PURPOSE


Physiological pancreaticoduodenal uptake of radiolabeled exendin-4 in Brunner glands of the proximal duodenum is the most common pitfall for false interpretation of glucagon-like peptide-1 receptor (GLP-1R) imaging. The aim of this study was to analyze the pancreaticoduodenal uptake in GLP-1R PET/CT and SPECT/CT images and to identify additional potential reading pitfalls in patients with suspected insulinoma.
METHODS


A post hoc analysis of a prospective study, including 52 consecutive patients, was performed. All patients underwent 1 Ga-exendin-4 PET/CT and 2 In-exendin-4 SPECT/CT scans (4 and 72 hours postinjection) in a randomized crossover order. Three board-certified nuclear medicine physicians read all scans independently. They were unaware of other results. Reference standard was surgery with histopathological confirmation of an insulinoma/nesidioblastosis and normalization of blood glucose levels after surgery.
RESULTS


There were no false-positive readings. However, there were a number of false-negative PET/CT and SPECT/CT readings, respectively: (1) due to false interpretation of uptake in the pancreaticoduodenal region (falsely interpreted as physiological uptake in Brunner glands instead of an insulinoma in 0.6% vs 9.0%), (2) due to ectopic insulinoma (0% vs 2.6%), (3) due to small insulinoma (1.9% vs 5.1%), (4) due to insulinoma overlap with kidneys (1.9% vs 4.5%), and (5) due to nesidioblastosis (0.6% and 1.9%). Pitfalls were identified in all GLP-1R PET/CT and SPECT/CT scans.
CONCLUSIONS


Peripancreatic uptake, small size of an insulinoma, insulinoma overlap with kidneys, and presence of nesidioblastosis are potential pitfalls in GLP-1R imaging, which can lead to false reading results.",2020,There were no false-positive readings.,"['patients with suspected insulinoma', '52 consecutive patients, was performed']",['GLP-1R PET/CT and SPECT/CT images'],"['blood glucose levels', 'ectopic insulinoma']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0021670', 'cui_str': 'Insulinoma'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0378073', 'cui_str': 'GLP-1R Receptor'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}, {'cui': 'C3472245', 'cui_str': 'Single photon emission computed tomography with computed tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0340464', 'cui_str': 'Ectopic beats'}, {'cui': 'C0021670', 'cui_str': 'Insulinoma'}]",52.0,0.0465109,There were no false-positive readings.,"[{'ForeName': 'Kwadwo', 'Initials': 'K', 'LastName': 'Antwi', 'Affiliation': 'From the Clinic of Radiology and Nuclear Medicine.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Hepprich', 'Affiliation': 'Division of Endocrinology, Diabetology and Metabolism, University Hospital Basel.'}, {'ForeName': 'Natasha A', 'Initials': 'NA', 'LastName': 'Müller', 'Affiliation': 'Faculty of Clinical Medicine, University of Basel, Basel.'}, {'ForeName': 'Jean Claude', 'Initials': 'JC', 'LastName': 'Reubi', 'Affiliation': 'Division of Cell Biology and Experimental Cancer Research, Institute of Pathology, University of Bern, Bern.'}, {'ForeName': 'Melpomeni', 'Initials': 'M', 'LastName': 'Fani', 'Affiliation': 'From the Clinic of Radiology and Nuclear Medicine.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Rottenburger', 'Affiliation': 'From the Clinic of Radiology and Nuclear Medicine.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Nicolas', 'Affiliation': 'From the Clinic of Radiology and Nuclear Medicine.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Kaul', 'Affiliation': 'From the Clinic of Radiology and Nuclear Medicine.'}, {'ForeName': 'Emanuel R', 'Initials': 'ER', 'LastName': 'Christ', 'Affiliation': 'Division of Endocrinology, Diabetology and Metabolism, University Hospital Basel.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Wild', 'Affiliation': 'From the Clinic of Radiology and Nuclear Medicine.'}]",Clinical nuclear medicine,['10.1097/RLU.0000000000003124']
1162,32554380,"Effectiveness of an 8-Week Web-Based Mindfulness Virtual Community Intervention for University Students on Symptoms of Stress, Anxiety, and Depression: Randomized Controlled Trial.","BACKGROUND


A student mental health crisis is increasingly acknowledged and will only intensify with the COVID-19 crisis. Given accessibility of methods with demonstrated efficacy in reducing depression and anxiety (eg, mindfulness meditation and cognitive behavioral therapy [CBT]) and limitations imposed by geographic obstructions and localized expertise, web-based alternatives have become vehicles for scaled-up delivery of benefits at modest cost. Mindfulness Virtual Community (MVC), a web-based program informed by CBT constructs and featuring online videos, discussion forums, and videoconferencing, was developed to target depression, anxiety, and experiences of excess stress among university students.
OBJECTIVE


The aim of this study was to assess the effectiveness of an 8-week web-based mindfulness and CBT program in reducing symptoms of depression, anxiety, and stress (primary outcomes) and increasing mindfulness (secondary outcome) within a randomized controlled trial (RCT) with undergraduate students at a large Canadian university.
METHODS


An RCT was designed to assess undergraduate students (n=160) who were randomly allocated to a web-based guided mindfulness-CBT condition (n=80) or to a waitlist control (WLC) condition (n=80). The 8-week intervention consisted of a web-based platform comprising (1) 12 video-based modules with psychoeducation on students' preidentified life challenges and applied mindfulness practice; (2) anonymous peer-to-peer discussion forums; and (3) anonymous, group-based, professionally guided 20-minute live videoconferences. The outcomes (depression, anxiety, stress, and mindfulness) were measured via an online survey at baseline and at 8 weeks postintervention using the Patient Health Questionnaire-9 (PHQ9), the Beck Anxiety Inventory (BAI), the Perceived Stress Scale (PSS), and the Five Facets Mindfulness Questionnaire Short Form (FFMQ-SF). Analyses employed generalized estimation equation methods with AR(1) covariance structures and were adjusted for possible covariates (gender, age, country of birth, ethnicity, English as first language, paid work, unpaid work, relationship status, physical exercise, self-rated health, and access to private mental health counseling).
RESULTS


Of the 159 students who provided T1 data, 32 were males and 125 were females with a mean age of 22.55 years. Participants in the MVC (n=79) and WLC (n=80) groups were similar in sociodemographic characteristics at T1 with the exception of gender and weekly hours of unpaid volunteer work. At postintervention follow-up, according to the adjusted comparisons, there were statistically significant between-group reductions in depression scores (β=-2.21, P=.01) and anxiety scores (β=-4.82, P=.006), and a significant increase in mindfulness scores (β=4.84, P=.02) compared with the WLC group. There were no statistically significant differences in perceived stress for MVC (β=.64, P=.48) compared with WLC.
CONCLUSIONS


With the MVC intervention, there were significantly reduced depression and anxiety symptoms but no significant effect on perceived stress. Online mindfulness interventions can be effective in addressing common mental health conditions among postsecondary populations on a large scale, simultaneously reducing the current burden on traditional counseling services.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN12249616; http://www.isrctn.com/ISRCTN12249616.",2020,"There were no statistically significant differences in perceived stress for MVC (β = .64, P = .48) compared to WLC.
","['32 were males and 125 were females with a mean age of 22.55 years', 'undergraduate students at a large Canadian university', 'undergraduate students (n = 160', '159 students who provided T1 data', 'Participants in the MVC (n = 79) and WLC (n = 80) groups were similar in sociodemographic characteristics at T1 with the exception of gender and weekly hours of unpaid volunteer work', 'University Students on Symptoms of Stress, Anxiety, and Depression', 'university students']","['web-based guided mindfulness-CBT condition (n = 80) or to a waitlist control condition (WLC', 'Eight-Week Web-Based Mindfulness Virtual Community Intervention', 'mindfulness meditation and cognitive behavioural therapy [CBT', 'Mindfulness Virtual Community (MVC), a web-based program informed by cognitive behavioral therapy (CBT) constructs and featuring online videos, discussion forums, and videoconferencing', 'eight-week web-based mindfulness and cognitive behavioural therapy (CBT) program', 'Online mindfulness interventions', ""web-based platform consisting of (1) 12 video-based modules with psycho-education on students' preidentified life challenges and applied mindfulness practice; (2) anonymous peer-to-peer discussion forums; and (3) anonymous, group-based, professionally guided 20-minute live videoconferences""]","['mindfulness scores', 'outcomes (depression, anxiety, stress, and mindfulness', 'depression scores', 'Patient Health Questionniare-9 (PHQ9), the Beck Anxiety Inventory (BAI), the Perceived Stress Scale (PSS), and the Five Facets Mindfulness Questionnaire Short Form (FFMQ-SF', 'depression and anxiety symptoms', 'anxiety scores', 'symptoms of depression, anxiety, and stress (primary outcomes', 'perceived stress for MVC']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",160.0,0.0566538,"There were no statistically significant differences in perceived stress for MVC (β = .64, P = .48) compared to WLC.
","[{'ForeName': 'Christo', 'Initials': 'C', 'LastName': 'El Morr', 'Affiliation': 'School of Health Policy and Management, York University, Toronto, ON, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ritvo', 'Affiliation': 'School of Kinesiology and Health Science, York University, Toronto, ON, Canada.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Ahmad', 'Affiliation': 'School of Health Policy and Management, York University, Toronto, ON, Canada.'}, {'ForeName': 'Rahim', 'Initials': 'R', 'LastName': 'Moineddin', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'School of Health Policy and Management, York University, Toronto, ON, Canada.'}]",JMIR mental health,['10.2196/18595']
1163,32555582,Malleability of rumination: An exploratory model of CBT-based plasticity and long-term reduced risk for depressive relapse among youth from a pilot randomized clinical trial.,"CLINICAL TRIALS REGISTRATION


NCT01905267, https://clinicaltrials.gov/ct2/show/NCT01905267.",2020,"CLINICAL TRIALS REGISTRATION


NCT01905267, https://clinicaltrials.gov/ct2/show/NCT01905267.",[],[],[],[],[],[],,0.264659,"CLINICAL TRIALS REGISTRATION


NCT01905267, https://clinicaltrials.gov/ct2/show/NCT01905267.","[{'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Bessette', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, United States of America.'}, {'ForeName': 'Rachel H', 'Initials': 'RH', 'LastName': 'Jacobs', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Heleniak', 'Affiliation': 'Department of Psychology, Columbia University, New York City, NY, United States of America.'}, {'ForeName': 'Amy T', 'Initials': 'AT', 'LastName': 'Peters', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States of America.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Welsh', 'Affiliation': 'Department of Psychiatry, University of Utah, Salt Lake City, UT, United States of America.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Watkins', 'Affiliation': 'Mood Disorders Centre, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Langenecker', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, United States of America.'}]",PloS one,['10.1371/journal.pone.0233539']
1164,32555681,Improving measles vaccine uptake rates in Nigeria: An RCT evaluating the impact of incentive sizes and reminder calls on vaccine uptake.,"OBJECTIVE


To assess the impact of increasing incentive size and reminder calls on the measles vaccine uptake rate.
DESIGN


Randomized controlled trial, randomized at individual level, stratified by clinic.
SETTING


Nigeria.
PARTICIPANTS


1088 caregivers with children aged nine months or older; had received at least one previous conditional cash transfer (CCT) at a program clinic, had received their Penta-3 immunization but had not yet received their measles immunization, and the caregiver had provided a phone number.
INTERVENTION


Nine clinics were randomized to two models; caregivers in Model 1 received a default of 2000 Nigerian Naira (NGN) for completing the measles vaccine, and those in Model 2 received by 3000 NGN. Caregivers from the respective clinics were then randomized to one of the four arms: 1) control (baseline amount of 2000 NGN or 3000 NGN), 2) baseline amount plus a reminder call, 3) baseline amount plus 1000 NGN and a reminder call, and 4) baseline amount plus 3000 NGN and a reminder call.
MAIN OUTCOME MEASURE


Receipt of measles vaccine as reported on a child health card.
RESULTS


Overall, there was no clear trend that increasing the incentive amount resulted in an increase in vaccine uptake rates. In Model 1 households, an additional 1000 NGN and 3000 NGN resulted in a 6.4 percentage point (95% CI: -2.3-15, p-value = 0.15) and 11.8 percentage point (95% CI: 3.9-19.6, p-value = 0.003) increase in the probability of completing the measles vaccines, respectively. This increase, however, was only significant for the 3000 NGN increase. On the other hand, in Model 2 households, increasing the incentive by 1000 NGN and 3000 NGN increased the probability by 3.3 (95% CI: -3.8-10.4, p-value = 0.36) and 3.3 (95% CI: -3.7-10.4, p-value = 0.35) percentage points. These increases were not statistically significant. Adding reminder calls to CCTs increased the probability of completing the measles vaccine; caregivers who received reminder calls plus CCTs were 5.1 percentage points more likely to get their children vaccinated (95% CI: 0.50-9.8, p-value = 0.03) compared to those who received CCTs and did not receive a reminder call. These results were largely driven by caregivers who went to clinics in Model 1.
CONCLUSION


A combination of increasing incentive amounts and reminder calls modestly improves measles immunization rates. However, this program also shows that there is substantial regional heterogeneity in response to both incentives and calls. While one possible conclusion is that a larger incentive and phone reminders are more likely to work in higher income and higher baseline coverage settings, the study is not designed to evaluate this claim. Rather, policymakers could consider experimenting with a similar low-cost calling study as part of the design of other cash transfer programs to identify whether adding reminder phone calls could increase the impact of the program.",2020,"NGN resulted in a 6.4 percentage point (95% CI: -2.3-15, p-value = 0.15) and 11.8 percentage point (95% CI: 3.9-19.6, p-value = 0.003) increase in the probability of completing the measles vaccines, respectively.","['Nigeria', '1088 caregivers with children aged nine months or older']","['least one previous conditional cash transfer (CCT) at a program clinic, had received their Penta-3 immunization but had not yet received their measles immunization, and the caregiver had provided a phone number', 'control (baseline amount of 2000 NGN or 3000 NGN), 2) baseline amount plus a reminder call, 3) baseline amount plus 1000 NGN and a reminder call, and 4) baseline amount plus 3000 NGN and a reminder call', 'vaccine', 'Model 1 received a default of 2000 Nigerian Naira (NGN) for completing the measles vaccine, and those in Model 2 received by 3000 NGN', 'CCTs']","['vaccine uptake rates', 'measles immunization rates']","[{'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0025007', 'cui_str': 'Measles'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1556089', 'cui_str': 'Nigerians'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0025010', 'cui_str': 'Measles vaccine'}, {'cui': 'C4049005', 'cui_str': 'Cataract, total congenital with posterior sutural opacities in Heterozygotes'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}]",9.0,0.319228,"NGN resulted in a 6.4 percentage point (95% CI: -2.3-15, p-value = 0.15) and 11.8 percentage point (95% CI: 3.9-19.6, p-value = 0.003) increase in the probability of completing the measles vaccines, respectively.","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Brownstone', 'Affiliation': 'IDinsight, San Francisco, California, United States of America.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Connor', 'Affiliation': 'IDinsight, San Francisco, California, United States of America.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Stein', 'Affiliation': 'IDinsight, San Francisco, California, United States of America.'}]",PloS one,['10.1371/journal.pone.0233149']
1165,32555695,"Prognostic factors for changes in the timed 4-stair climb in patients with Duchenne muscular dystrophy, and implications for measuring drug efficacy: A multi-institutional collaboration.","The timed 4-stair climb (4SC) assessment has been used to measure function in Duchenne muscular dystrophy (DMD) practice and research. We sought to identify prognostic factors for changes in 4SC, assess their consistency across data sources, and the extent to which prognostic scores could be useful in DMD clinical trial design and analysis. Data from patients with DMD in the placebo arm of a phase 3 trial (Tadalafil DMD trial) and two real-world sources (Universitaire Ziekenhuizen, Leuven, Belgium [Leuven] and Cincinnati Children's Hospital Medical Center [CCHMC]) were analyzed. One-year changes in 4SC completion time and velocity (stairs/second) were analyzed. Prognostic models included age, height, weight, steroid use, and multiple timed function tests and were developed using multivariable regression, separately in each data source. Simulations were used to quantify impacts on trial sample size requirements. Data on 1-year changes in 4SC were available from the Tadalafil DMD trial (n = 92) Leuven (n = 67), and CCHMC (n = 212). Models incorporating multiple timed function tests, height, and weight significantly improved prognostic accuracy for 1-year change in 4SC (R2: 29%-36% for 4SC velocity, and 29%-34% for 4SC time) compared to models including only age, baseline 4SC and steroid duration (R2:8%-17% for 4SC velocity and 2%-13% for 4SC time). Measures of walking and rising ability contributed important prognostic information for changes in 4SC. In a randomized trial with equal allocation to treatment and placebo, adjustment for such a prognostic score would enable detection (at 80% power) of a treatment effect of 0.25 stairs/second with 100-120 patients, compared to 170-190 patients without prognostic score adjustment. Combining measures of ambulatory function doubled prognostic accuracy for 1-year changes in 4SC completion time and velocity. Randomized clinical trials incorporating a validated prognostic score could reduce sample size requirements by approximately 40%. Knowledge of important prognostic factors can also inform adjusted comparisons to external controls.",2020,"Models incorporating multiple timed function tests, height, and weight significantly improved prognostic accuracy for 1-year change in 4SC (R2: 29%-36% for 4SC velocity, and 29%-34% for 4SC time) compared to models including only age, baseline 4SC and steroid duration (R2:8%-17% for 4SC velocity and 2%-13% for 4SC time).","['patients with Duchenne muscular dystrophy', 'patients with DMD in the']",['placebo'],"['sample size requirements', '4SC completion time and velocity (stairs/second']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013264', 'cui_str': 'Duchenne muscular dystrophy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205436', 'cui_str': 'Second'}]",212.0,0.0551207,"Models incorporating multiple timed function tests, height, and weight significantly improved prognostic accuracy for 1-year change in 4SC (R2: 29%-36% for 4SC velocity, and 29%-34% for 4SC time) compared to models including only age, baseline 4SC and steroid duration (R2:8%-17% for 4SC velocity and 2%-13% for 4SC time).","[{'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Goemans', 'Affiliation': 'Department of Child Neurology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Wong', 'Affiliation': 'Department of Pediatrics, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Van den Hauwe', 'Affiliation': 'Department of Child Neurology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Signorovitch', 'Affiliation': 'Analysis Group Inc., Boston, Massachusetts, United States of America.'}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Sajeev', 'Affiliation': 'Analysis Group Inc., Boston, Massachusetts, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cox', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, United States of America.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Landry', 'Affiliation': 'Eli Lilly and Company, Toronto, Ontario, Canada.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Jenkins', 'Affiliation': 'Analysis Group Inc., London, United Kingdom.'}, {'ForeName': 'Ibrahima', 'Initials': 'I', 'LastName': 'Dieye', 'Affiliation': 'Analysis Group Inc., Boston, Massachusetts, United States of America.'}, {'ForeName': 'Zhiwen', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': 'Analysis Group Inc., Boston, Massachusetts, United States of America.'}, {'ForeName': 'Intekhab', 'Initials': 'I', 'LastName': 'Hossain', 'Affiliation': 'Analysis Group Inc., Boston, Massachusetts, United States of America.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Ward', 'Affiliation': 'The Collaborative Trajectory Analysis Project, Cambridge, Massachusetts, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0232870']
1166,32567140,"Physical activity, sitting time and sleep duration before and during pregnancy and pregnancy outcomes: A prospective panel study.","AIMS AND OBJECTIVES


To examine how changes in physical activity, sitting time and sleep duration through pre-, mid- and late pregnancy are in association with Caesarean section, medically indicated Caesarean section and small for gestational age.
BACKGROUND


While circadian activities could change throughout pregnancy, studies exploring the effect of change in those activities on pregnancy outcomes remain limited.
DESIGN


This study applied a prospective panel design.
METHODS


A self-reported questionnaire was used to assess the three activities before and during pregnancy and was administered three times from August 2015-July 2017. Multiple logistic regression models were used. The analysis included 488, 477 and 455 participants in the models for Caesarean section, medically indicated Caesarean section and small for gestational age, respectively. This study followed the STROBE guidelines.
RESULTS


The mean age of participants was 32.18 years, and more than half (54.90%) were primiparous. Sleep duration of >8 hr/day before pregnancy and experiencing a decrease in mid-pregnancy was a risk factor for Caesarean section and medically indicated Caesarean section. Sitting ≥8 hr/weekday in pre-, mid- and late pregnancy had a protective effect for Caesarean section and medically indicated Caesarean section. Sitting <8 hr in mid-pregnancy and experiencing a decrease in late pregnancy was a risk factor for small-for-gestational-age infants. Physical activity was not significantly related to pregnancy outcomes.
CONCLUSION


Sleep duration of 7-8 hr and sitting time of more than 8 hr/day seem beneficial for women both before and during pregnancy.
RELEVANCE TO CLINICAL PRACTICE


Health professionals could assess pregnant women or those intending to become pregnant regarding their sleep and sitting behaviour and provide relevant interventions.",2020,"Physical activity was not significantly related to pregnancy outcomes.
","['The mean age of participants was 32.18 years, and more than half (54.90%) were primiparous', 'The analysis included 488, 477, and 455 participants in the models for caesarean section, medically-indicated caesarean section, and small for gestational age, respectively']",['Sitting'],"['Physical Activity, Sitting Time, and Sleep Duration', 'Physical activity', 'physical activity, sitting time, and sleep duration through pre-, mid-, and late pregnancy in association with caesarean section, medically-indicated caesarean section, and small for gestational age', 'Sleep duration', 'protective effect for caesarean section and medically-indicated caesarean section', 'late pregnancy']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0188153,"Physical activity was not significantly related to pregnancy outcomes.
","[{'ForeName': 'Shiue-Shan', 'Initials': 'SS', 'LastName': 'Weng', 'Affiliation': 'School of Nursing, Institute of Community Health Care, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Yu-Hsiang', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynecology, Taipei Tzu Chi Hospital, Taipei, Taiwan.'}, {'ForeName': 'Li-Yin', 'Initials': 'LY', 'LastName': 'Chien', 'Affiliation': 'School of Nursing, Institute of Community Health Care, National Yang-Ming University, Taipei, Taiwan.'}]",Journal of clinical nursing,['10.1111/jocn.15388']
1167,32563378,"Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial.","BACKGROUND


Tranexamic acid reduces surgical bleeding and reduces death due to bleeding in patients with trauma. Meta-analyses of small trials show that tranexamic acid might decrease deaths from gastrointestinal bleeding. We aimed to assess the effects of tranexamic acid in patients with gastrointestinal bleeding.
METHODS


We did an international, multicentre, randomised, placebo-controlled trial in 164 hospitals in 15 countries. Patients were enrolled if the responsible clinician was uncertain whether to use tranexamic acid, were aged above the minimum age considered an adult in their country (either aged 16 years and older or aged 18 years and older), and had significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding. Patients were randomly assigned by selection of a numbered treatment pack from a box containing eight packs that were identical apart from the pack number. Patients received either a loading dose of 1 g tranexamic acid, which was added to 100 mL infusion bag of 0·9% sodium chloride and infused by slow intravenous injection over 10 min, followed by a maintenance dose of 3 g tranexamic acid added to 1 L of any isotonic intravenous solution and infused at 125 mg/h for 24 h, or placebo (sodium chloride 0·9%). Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcome was death due to bleeding within 5 days of randomisation; analysis excluded patients who received neither dose of the allocated treatment and those for whom outcome data on death were unavailable. This trial was registered with Current Controlled Trials, ISRCTN11225767, and ClinicalTrials.gov, NCT01658124.
FINDINGS


Between July 4, 2013, and June 21, 2019, we randomly allocated 12 009 patients to receive tranexamic acid (5994, 49·9%) or matching placebo (6015, 50·1%), of whom 11 952 (99·5%) received the first dose of the allocated treatment. Death due to bleeding within 5 days of randomisation occurred in 222 (4%) of 5956 patients in the tranexamic acid group and in 226 (4%) of 5981 patients in the placebo group (risk ratio [RR] 0·99, 95% CI 0·82-1·18). Arterial thromboembolic events (myocardial infarction or stroke) were similar in the tranexamic acid group and placebo group (42 [0·7%] of 5952 vs 46 [0·8%] of 5977; 0·92; 0·60 to 1·39). Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of 5952 vs 26 [0·4%] of 5977; RR 1·85; 95% CI 1·15 to 2·98).
INTERPRETATION


We found that tranexamic acid did not reduce death from gastrointestinal bleeding. On the basis of our results, tranexamic acid should not be used for the treatment of gastrointestinal bleeding outside the context of a randomised trial.
FUNDING


UK National Institute for Health Research Health Technology Assessment Programme.",2020,Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of 5952 vs 26 [0·4%] of 5977;,"['patients with gastrointestinal bleeding', 'Patients were enrolled if the responsible clinician was uncertain whether to use tranexamic acid, were aged above the minimum age considered an adult in their country (either aged 16 years and older or aged 18 years and older), and had significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding', 'patients with trauma', '164 hospitals in 15 countries', 'patients with acute gastrointestinal bleeding (HALT-IT', 'Between July 4, 2013, and June 21, 2019, we randomly allocated 12\u2008009 patients to receive']","['Tranexamic acid', 'placebo', 'matching placebo', 'tranexamic acid added to 1 L of any isotonic intravenous solution and infused at 125 mg/h for 24 h, or placebo (sodium chloride 0·9', 'tranexamic acid', '0·9% sodium chloride']","['death due to bleeding', 'death and thromboembolic events', 'Venous thromboembolic events (deep vein thrombosis or pulmonary embolism', 'Arterial thromboembolic events (myocardial infarction or stroke', 'Death due to bleeding', 'death from gastrointestinal bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C1273518', 'cui_str': 'Responsible to'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0024050', 'cui_str': 'Lower gastrointestinal hemorrhage'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0266807', 'cui_str': 'Acute gastrointestinal hemorrhage'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C0104485', 'cui_str': 'AT 125'}, {'cui': 'C0439421', 'cui_str': 'mg/h'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}]",12009.0,0.734066,Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of 5952 vs 26 [0·4%] of 5977;,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30848-5']
1168,32565318,Impact of Sequencing of Androgen Suppression and Radiation Therapy on Testosterone Recovery in Localized Prostate Cancer.,"PURPOSE


We performed a secondary analysis of a phase 3 randomized trial to determine the influence of sequencing of radiation therapy and androgen deprivation therapy (ADT) on posttreatment testosterone recovery and implications of testosterone recovery on subsequent relapse.
METHODS AND MATERIALS


Patients with localized prostate cancer with Gleason score ≤7, clinical stage T1b to T3a, and prostate-specific antigen <30 ng/mL were randomized to neoadjuvant and concurrent ADT for 6 months starting 4 months before prostate radiation therapy (NHT arm) or concurrent and adjuvant ADT for 6 months starting simultaneously with radiation therapy (CAHT arm). Full testosterone recovery (FTR) was defined as recovery of testosterone to >10.5 nmol/L in patients with baseline ≥10.5 nmol/L or to baseline level in patients with baseline <10.5 nmol/L. Restricted mean survival time (RMST) since ADT initiation to supracastrate testosterone level (>1.7 nmol/L), and to FTR was compared between the arms using a truncation time point of 36 months.
RESULTS


The adjusted difference in RMST to supracastrate testosterone between the CAHT and NHT arm was 1.5 months (95% confidence interval [CI], 0.5-2.5; P = .005). No difference was noted in RMST to FTR between the arms (18.7 vs 18.5 months, adjusted difference: 0.5; 95% CI, -1.4 to 2.4; P = .61). There was no evidence of heterogeneity of treatment effect (interaction P = .76) on risk of relapse over subgroups stratified by testosterone recovery to supracastrate level at 15 months after start of ADT. Based on a multistate Markov model, no independent effect of time to FTR on risk of subsequent relapse was observed (adjusted hazard ratio: 1.02; 95% CI, 0.96-1.08).
CONCLUSIONS


Patients should be counseled that an additional 12 months on average is needed for FTR to occur after treatment with prostate radiation therapy and 6 months of ADT. This is independent of the sequencing of ADT and radiation therapy. Furthermore, recovery of testosterone does not appear to affect the risk of subsequent relapse.",2020,There was no evidence of heterogeneity of treatment effect (interaction p=0.76) on risk of relapse over subgroups stratified by testosterone recovery to supra-castrate level at 15 months after start of ADT.,"['Localized prostate cancer patients with Gleason', 'Localized Prostate Cancer']","['neoadjuvant and concurrent ADT', 'prostate radiotherapy (NHT arm) or concurrent and adjuvant ADT', 'Androgen Suppression and Radiotherapy', 'radiotherapy and ADT', 'prostate radiotherapy']","['RMST to FTR', 'mean survival time (RMST) since ADT initiation to supra-castrate testosterone level', 'RMST to supra-castrate testosterone', 'risk of subsequent relapse', 'risk of relapse', 'Full testosterone recovery (FTR', 'score ≤7, clinical stage T1b-T3a, and prostate-specific antigen', 'recovery of testosterone']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0948317', 'cui_str': 'Radiotherapy to prostate'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0086595', 'cui_str': 'Mean Survival Time'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205563', 'cui_str': 'Clinical stage finding'}, {'cui': 'C0475385', 'cui_str': 'Tumor stage T1b'}, {'cui': 'C0475390', 'cui_str': 'Tumor stage T3a'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}]",,0.251948,There was no evidence of heterogeneity of treatment effect (interaction p=0.76) on risk of relapse over subgroups stratified by testosterone recovery to supra-castrate level at 15 months after start of ADT.,"[{'ForeName': 'Soumyajit', 'Initials': 'S', 'LastName': 'Roy', 'Affiliation': 'Radiation Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland; Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada; Department of Radiology, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Grimes', 'Affiliation': 'Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada.'}, {'ForeName': 'Libni', 'Initials': 'L', 'LastName': 'Eapen', 'Affiliation': 'Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada; Department of Radiology, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Spratt', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Malone', 'Affiliation': 'Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Craig', 'Affiliation': 'Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Morgan', 'Affiliation': 'Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada; Department of Radiology, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Malone', 'Affiliation': 'Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada; Department of Radiology, University of Ottawa, Ottawa, Ontario, Canada. Electronic address: smalone@toh.ca.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.06.017']
1169,32565319,Efficacy of Dose-Escalated Chemoradiation on Complete Tumor Response in Patients with Locally Advanced Rectal Cancer (RECTAL-BOOST): A Phase 2 Randomized Controlled Trial.,"PURPOSE


Pathologic complete tumor response after chemoradiation in patients with locally advanced rectal cancer (LARC) is associated with a favorable prognosis and allows organ-sparing treatment strategies. In the RECTAL-BOOST trial, we aimed to investigate the effect of an external radiation boost to the tumor before chemoradiation on pathologic or sustained clinical complete tumor response in LARC.
METHODS AND MATERIALS


This multicenter, nonblinded, phase 2 randomized controlled trial followed the trials-within-cohorts design, which is a pragmatic trial design allowing cohort participants to be randomized for an experimental intervention. Patients in the intervention group are offered the intervention (and can either accept or refuse this), whereas patients in the control group are not notified about the randomization. Participants of a colorectal cancer cohort referred for chemoradiation of LARC to either of 2 radiation therapy centers were eligible. Patients were randomized to no boost or an external radiation boost (5 × 3 Gy) without concurrent chemotherapy, directly followed by standard pelvic chemoradiation (25 × 2 Gy with concurrent capecitabine). The primary outcome was pathologic complete response (ie, ypT0N0) in patients with planned surgery at 12 weeks, or, as surrogate for pathologic complete response, a 2-year sustained clinical complete response for patients treated with an organ preservation strategy. Analyses were intention to treat. The study was registered with ClinicalTrials.gov, number NCT01951521.
RESULTS


Between September 2014 and July 2018, 128 patients were randomized. Fifty-one of the 64 (79.7%) patients in the intervention group accepted and received a boost. Compared with the control group, fewer patients in the intervention group had a cT4 stage and a low rectal tumor (31.3% vs 17.2% and 56.3% vs 45.3%, respectively), and more patients had a cN2 stage (59.4% vs 70.3%, respectively). Rate of pathologic or sustained clinical complete tumor response was similar between the groups: 23 of 64 (35.9%; 95% confidence interval [CI], 24.3-48.9) in the intervention group versus 24 of 64 (37.5%; 95% CI, 25.7-50.5) in the control group (odds ratio [OR] = 0.94; 95% CI, 0.46-1.92). Near-complete or complete tumor regression was more common in the intervention group (34 of 49; 69.4%) than in the control group (24 of 53; 45.3%; (OR = 2.74, 95% CI 1.21-6.18). Grade ≥3 acute toxicity was comparable: 6 of 64 (9.4%) in the intervention group versus 5 of 64 (7.8%) in the control group (OR = 1.22; 95% CI, 0.35-4.22).
CONCLUSIONS


Dose escalation with an external radiation therapy boost to the tumor before neoadjuvant chemoradiation did not increase the pathologic or sustained clinical complete tumor response rate in LARC.",2020,"Compared with the control group, fewer patients in the intervention group had a cT4-stage and a low rectal tumour (31.3% versus 17.2% and 56.3% versus 45.3% respectively), and more patients had a cN2-stage (59.4% versus 70.3% respectively).","['patients with locally advanced rectal cancer (RECTAL-BOOST', 'Between Sept 2014 and July 2018, 128 patients were randomised', 'patients with locally advanced rectal cancer', 'Participants of a colorectal cancer cohort referred for chemoradiation of LARC to either of two radiotherapy centres were eligible']","['external radiation boost', 'external radiotherapy', 'external radiation boost (5 x 3 Gy) without concurrent chemotherapy directly followed by standard pelvic chemoradiation (25 x 2 Gy with concurrent capecitabine', 'dose-escalated chemoradiation']","['Rate of pathological or sustained clinical complete tumour response', 'pathological complete response (pCR, i.e. ypT0N0', 'cN2-stage', 'complete tumour response', 'cT4-stage and a low rectal tumour', 'Grade >3 acute toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C2919491', 'cui_str': 'Boost radiation therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",128.0,0.233842,"Compared with the control group, fewer patients in the intervention group had a cT4-stage and a low rectal tumour (31.3% versus 17.2% and 56.3% versus 45.3% respectively), and more patients had a cN2-stage (59.4% versus 70.3% respectively).","[{'ForeName': 'Alice M', 'Initials': 'AM', 'LastName': 'Couwenberg', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, the Netherlands. Electronic address: A.M.Couwenberg@umcutrecht.nl.'}, {'ForeName': 'Johannes P M', 'Initials': 'JPM', 'LastName': 'Burbach', 'Affiliation': 'Department of Surgery, Medical Center Leeuwarden, the Netherlands.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Berbee', 'Affiliation': 'Department of Radiation Oncology (MAASTRO), GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Miangela M', 'Initials': 'MM', 'LastName': 'Lacle', 'Affiliation': 'Department of Pathology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Arensman', 'Affiliation': 'Department of Pathology, Meander Medical Centre, Amersfoort, the Netherlands.'}, {'ForeName': 'Mihaela G', 'Initials': 'MG', 'LastName': 'Raicu', 'Affiliation': 'Department of Pathology, St. Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Wessels', 'Affiliation': 'Department of Radiology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Verdult', 'Affiliation': 'Department of Radiology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Roodhart', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Onne', 'Initials': 'O', 'LastName': 'Reerink', 'Affiliation': 'Department of Radiation Oncology, Insala Clinic, Zwolle, The Netherlands.'}, {'ForeName': 'Sieske', 'Initials': 'S', 'LastName': 'Hoendervangers', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Buijsen', 'Affiliation': 'Department of Radiation Oncology (MAASTRO), GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Heike I', 'Initials': 'HI', 'LastName': 'Grabsch', 'Affiliation': ""Department of Pathology, GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands; Pathology and Data Analytics, Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, United Kingdom.""}, {'ForeName': 'Apollo', 'Initials': 'A', 'LastName': 'Pronk', 'Affiliation': 'Department of Surgery, Diakonessenhuis, Utrecht, The Netherlands.'}, {'ForeName': 'Esther C J', 'Initials': 'ECJ', 'LastName': 'Consten', 'Affiliation': 'Department of Surgery, Meander Medical Center, Amersfoort, The Netherlands; Department of Surgery, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Anke B', 'Initials': 'AB', 'LastName': 'Smits', 'Affiliation': 'Department of Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Joost T', 'Initials': 'JT', 'LastName': 'Heikens', 'Affiliation': 'Department of Surgery, Hospital Rievierenland, Tiel, The Netherlands.'}, {'ForeName': 'Ane L', 'Initials': 'AL', 'LastName': 'Appelt', 'Affiliation': ""Radiotherapy Research Group, Leeds Institute of Medicine at St James's, University of Leeds, Leeds, United Kingdom; Leeds Cancer Centre, St James University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Wilhelmina M U', 'Initials': 'WMU', 'LastName': 'van Grevenstein', 'Affiliation': 'Department of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Helena M', 'Initials': 'HM', 'LastName': 'Verkooijen', 'Affiliation': 'Imaging Division, University Medical Center Utrecht, Utrecht, The Netherlands; Faculty of Medicine, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Martijn P W', 'Initials': 'MPW', 'LastName': 'Intven', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, the Netherlands.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.06.013']
1170,32573779,"Oncological outcomes for patients with locally advanced prostate cancer treated with neoadjuvant endocrine and external-beam radiation therapy followed by adjuvant continuous/intermittent endocrine therapy in an open-label, randomized, phase 3 trial.","BACKGROUND


To date, research has not determined the optimal procedure for adjuvant androgen deprivation therapy (ADT) in patients with locally advanced prostate cancer (PCa) treated for 6 months with neoadjuvant ADT and external-beam radiation therapy (EBRT).
METHODS


A multicenter, randomized, phase 3 trial enrolled 303 patients with locally advanced PCa between 2001 and 2006. Participants were treated with neoadjuvant ADT for 6 months. Then, 280 patients whose prostate-specific antigen levels were less than pretreatment levels and less than 10 ng/mL were randomized. All 280 participants were treated with 72 Gy of EBRT in combination with adjuvant ADT for 8 months. Thereafter, participants were assigned to long-term ADT (5 years in all; arm 1) or intermittent ADT (arm 2). The primary endpoint was modified biochemical relapse-free survival (bRFS) with respect to nonmetastatic castration-resistant prostate cancer (nmCRPC) progression, clinical relapse, or any cause of death.
RESULTS


The median follow-up time after randomization was 8.2 years. Among the 136 and 144 men assigned to trial arms 1 and 2, respectively, 24 and 30 progressed to nmCRPC or clinical relapse, and 5 and 6 died of PCa. The 5-year modified bRFS rates were 84.8% and 82.8% in trial arms 1 and 2, respectively (hazard ratio, 1.132; 95% confidence interval, 0.744-1.722).
CONCLUSIONS


Although modified bRFS data did not demonstrate noninferiority for arm 2, intermittent adjuvant ADT after EBRT with 14 months of neoadjuvant and short-term adjuvant ADT is a promising treatment strategy, especially in a population of responders after 6 months of ADT for locally advanced PCa.",2020,"Although modified bRFS data did not demonstrate noninferiority for arm 2, intermittent adjuvant ADT after EBRT with 14 months of neoadjuvant and short-term adjuvant ADT is a promising treatment strategy, especially in a population of responders after 6 months of ADT for locally advanced PCa.","['280 patients whose prostate-specific antigen levels were less than pretreatment levels and less than 10\xa0ng/mL were randomized', '136 and 144 men assigned to trial arms 1 and 2, respectively, 24 and 30 progressed to nmCRPC or clinical relapse, and 5 and 6 died of PCa', '303 patients with locally advanced PCa between 2001 and 2006', 'patients with locally advanced prostate cancer (PCa) treated for 6\xa0months with', 'patients with locally advanced prostate cancer treated with', 'All 280 participants were treated with 72\xa0Gy of']","['neoadjuvant ADT', 'EBRT in combination with adjuvant ADT', 'adjuvant androgen deprivation therapy (ADT', 'intermittent ADT', 'neoadjuvant endocrine and external-beam radiation therapy followed by adjuvant continuous/intermittent endocrine therapy', 'neoadjuvant ADT and external-beam radiation therapy (EBRT']","['modified biochemical relapse-free survival (bRFS) with respect to nonmetastatic castration-resistant prostate cancer (nmCRPC) progression, clinical relapse, or any cause of death', '5-year modified bRFS rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",303.0,0.149061,"Although modified bRFS data did not demonstrate noninferiority for arm 2, intermittent adjuvant ADT after EBRT with 14 months of neoadjuvant and short-term adjuvant ADT is a promising treatment strategy, especially in a population of responders after 6 months of ADT for locally advanced PCa.","[{'ForeName': 'Kazuto', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Department of Urology, Gunma University Graduate School of Medicine, Maebashi, Japan.'}, {'ForeName': 'Mikio', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Urology, Isesaki Municipal Hospital, Isesaki, Japan.'}, {'ForeName': 'Motokiyo', 'Initials': 'M', 'LastName': 'Komiyama', 'Affiliation': 'Department of Urology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Naito', 'Affiliation': 'Department of Urology, Graduate School of Medicine, Kyusyu University, Fukuoka, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Nishimura', 'Affiliation': 'Department of Urology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Yonese', 'Affiliation': 'Department of Urology, Cancer Institute Hospital, Tokyo, Japan.'}, {'ForeName': 'Katsuyoshi', 'Initials': 'K', 'LastName': 'Hashine', 'Affiliation': 'Department of Urology, Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Department of Urology, Tokyo Medical Center, Tokyo, Japan.'}, {'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Arai', 'Affiliation': 'Department of Urology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Shinohara', 'Affiliation': 'Department of Urology, Tokyo Metropolitan Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Masumori', 'Affiliation': 'Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Shimizu', 'Affiliation': 'Department of Urology, Gunma Cancer Center Hospital, Ohta, Japan.'}, {'ForeName': 'Takefumi', 'Initials': 'T', 'LastName': 'Satoh', 'Affiliation': 'Department of Urology, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Yamauchi', 'Affiliation': 'Department of Urology, Ibaraki Prefectural Central Hospital, Kasama, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Tochigi', 'Affiliation': 'Department of Urology, Miyagi Cancer Center, Natori, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Takezawa', 'Affiliation': 'Department of Urology, Isesaki Municipal Hospital, Isesaki, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Urology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Yokomizo', 'Affiliation': 'Department of Urology, Graduate School of Medicine, Kyusyu University, Fukuoka, Japan.'}, {'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Kakimoto', 'Affiliation': 'Department of Urology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Iwao', 'Initials': 'I', 'LastName': 'Fukui', 'Affiliation': 'Department of Urology, Cancer Institute Hospital, Tokyo, Japan.'}, {'ForeName': 'Katsuyuki', 'Initials': 'K', 'LastName': 'Karasawa', 'Affiliation': 'Department of Radiation Oncology, Tokyo Metropolitan Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Taiji', 'Initials': 'T', 'LastName': 'Tsukamoto', 'Affiliation': 'Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Miwako', 'Initials': 'M', 'LastName': 'Nozaki', 'Affiliation': 'Department of Radiation Oncology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Hasumi', 'Affiliation': 'Department of Urology, Gunma Cancer Center Hospital, Ohta, Japan.'}, {'ForeName': 'Hiromichi', 'Initials': 'H', 'LastName': 'Ishiyama', 'Affiliation': 'Department of Radiation and Radiation Oncology, Kitasato University, Sagamihara, Japan.'}, {'ForeName': 'Mikinobu', 'Initials': 'M', 'LastName': 'Ohtani', 'Affiliation': 'Department of Urology, Ibaraki Prefectural Central Hospital, Kasama, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Kuwahara', 'Affiliation': 'Sendai Jin-Hinyokika, Sendai, Japan.'}, {'ForeName': 'Masaoki', 'Initials': 'M', 'LastName': 'Harada', 'Affiliation': 'Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ohashi', 'Affiliation': 'University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Kotake', 'Affiliation': 'Kotake Clinic, Osaka, Japan.'}, {'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Kakizoe', 'Affiliation': 'Japan Society for Cancer, Tokyo, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Department of Urology, Gunma University Graduate School of Medicine, Maebashi, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Yamanaka', 'Affiliation': 'Institute for Preventive Medicine, Kurosawa Hospital, Takasaki, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cancer,['10.1002/cncr.33034']
1171,32574006,A Randomized Comparison of Carbon Nanoparticles in Endoscopic Lymph Node Dissection Via the Bilateral Areola Approach for Papillary Thyroid Cancer.,"OBJECTIVE


We assess the value of carbon nanoparticles (CNP) staining in patients undergoing endoscopic thyroidectomy and central compartment lymph node (CLN) dissection via the bilateral areola approach [endoscopic thyroidectomy via bilateral areola approach (ETBAA)].
METHODS


This was a prospective randomized study. Three hundred two consecutive early-stage thyroid cancer patients eligible for ETBAA were recruited at the Division of Thyroid Surgery, China-Japan Union Hospital, Jilin University, China. CLN were mapped and retrieved under the guidance of stained or unstained CNP. The location, detection rates, positive nodes, and number of stained lymph nodes were compared.
RESULTS


ETBAA patients were randomly divided into a CNP group (n=152) and a control group (n=150). In the CNP group, the imaging of lymphatic flow could be observed in 1016 (95.9%) lymph nodes, whereas 43 (4.1%) were unstained. The mean number of stained lymph nodes in each procedure was 6.68 (range, 3 to 12). The total number of dissected lymph nodes was 1059 in the CNP group and 872 in the control group (P=0.00). There was a significant difference of inadvertent parathyroidectomy between the 2 groups: 0.5% versus 3.9% in lobectomy (P=0.035) and 0.6% versus 5.2% in total thyroidectomy (P=0.012). However, the rates of hypoparathyroidism were not significantly different (P>0.05). There were no cases of CNP-related adverse effects.
CONCLUSIONS


The lymphatic navigation by CNP increases the number of detected CLN without the involvement of radioactive isotopes. However, CNP did not lower hypocalcemia, did not improve parathyroid hormone range, and there was no significant difference in the percentage of metastatic lymph nodes between the 2 groups.",2020,There was a significant difference of inadvertent parathyroidectomy between the 2 groups: 0.5% versus 3.9% in lobectomy (P=0.035) and 0.6% versus 5.2% in total thyroidectomy (P=0.012).,"['Endoscopic Lymph Node Dissection', 'Three hundred two consecutive early-stage thyroid cancer patients eligible for ETBAA were recruited at the Division of Thyroid Surgery, China-Japan Union Hospital, Jilin University, China', 'patients undergoing endoscopic thyroidectomy and central compartment lymph node (CLN) dissection via the bilateral areola approach ', 'Papillary Thyroid Cancer']","['carbon nanoparticles (CNP) staining', 'endoscopic thyroidectomy via bilateral areola approach (ETBAA', 'Carbon Nanoparticles', 'CNP']","['total number of dissected lymph nodes', 'hypocalcemia', 'mean number of stained lymph nodes', 'location, detection rates, positive nodes, and number of stained lymph nodes', 'percentage of metastatic lymph nodes', 'inadvertent parathyroidectomy', 'rates of hypoparathyroidism', 'imaging of lymphatic flow', 'parathyroid hormone range']","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0222608', 'cui_str': 'Areola structure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0193769', 'cui_str': 'Operation on thyroid gland'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0238463', 'cui_str': 'Papillary thyroid carcinoma'}]","[{'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0222608', 'cui_str': 'Areola structure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205239', 'cui_str': 'Dissecting'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}, {'cui': 'C0020626', 'cui_str': 'Hypoparathyroidism'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",302.0,0.0547605,There was a significant difference of inadvertent parathyroidectomy between the 2 groups: 0.5% versus 3.9% in lobectomy (P=0.035) and 0.6% versus 5.2% in total thyroidectomy (P=0.012).,"[{'ForeName': 'Daqi', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Division of Thyroid Surgery, China-Japan Union Hospital of Jilin University, Jilin Provincial Key Laboratory of Surgical Translational Medicine, Jilin Provincial Precision Medicine Laboratory of Molecular Biology and Translational Medicine on Differentiated Thyroid Carcinoma.'}, {'ForeName': 'Yantao', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': 'Division of Thyroid Surgery, China-Japan Union Hospital of Jilin University, Jilin Provincial Key Laboratory of Surgical Translational Medicine, Jilin Provincial Precision Medicine Laboratory of Molecular Biology and Translational Medicine on Differentiated Thyroid Carcinoma.'}, {'ForeName': 'Gianlorenzo', 'Initials': 'G', 'LastName': 'Dionigi', 'Affiliation': 'Department of Human Pathology in Adulthood and Childhood ""G. Barresi"", Division for Endocrine and Minimally Invasive Surgery, University Hospital G. Martino, University of Messina, Messina, Italy.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""Division of Pathology, China-Japan Union Hospital of Jilin University, Changchun City, Jilin Province, People's Republic of China.""}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Division of Thyroid Surgery, China-Japan Union Hospital of Jilin University, Jilin Provincial Key Laboratory of Surgical Translational Medicine, Jilin Provincial Precision Medicine Laboratory of Molecular Biology and Translational Medicine on Differentiated Thyroid Carcinoma.'}, {'ForeName': 'Tie', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Division of Thyroid Surgery, China-Japan Union Hospital of Jilin University, Jilin Provincial Key Laboratory of Surgical Translational Medicine, Jilin Provincial Precision Medicine Laboratory of Molecular Biology and Translational Medicine on Differentiated Thyroid Carcinoma.'}, {'ForeName': 'Gaofeng', 'Initials': 'G', 'LastName': 'Xue', 'Affiliation': 'Division of Thyroid Surgery, China-Japan Union Hospital of Jilin University, Jilin Provincial Key Laboratory of Surgical Translational Medicine, Jilin Provincial Precision Medicine Laboratory of Molecular Biology and Translational Medicine on Differentiated Thyroid Carcinoma.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Division of Thyroid Surgery, China-Japan Union Hospital of Jilin University, Jilin Provincial Key Laboratory of Surgical Translational Medicine, Jilin Provincial Precision Medicine Laboratory of Molecular Biology and Translational Medicine on Differentiated Thyroid Carcinoma.'}]","Surgical laparoscopy, endoscopy & percutaneous techniques",['10.1097/SLE.0000000000000793']
1172,32574895,Randomized controlled study comparing tonsillectomy safety and patient satisfaction outcomes between HARMONIC ACE® + shears and monopolar diathermy in an adult population - A pilot study.,"PURPOSE


Various types of the harmonic scalpel blades have been used for tonsillectomy since the early 2000s with varying successes. The HARMONIC ACE® + 23 cm shears is a relatively new blade which has not been studied in an adult population yet.
METHODOLOGY


A randomized controlled pilot study was performed comparing the HARMONIC ACE® + 23 cm shears (HS) and monopolar electrocautery (EC) tonsillectomy in 20 patients. Intraoperative blood loss, pain control, return to normal diet and activity as well as patient satisfaction outcomes were compared between these two arms.
RESULTS


The operative time was comparable. Compared to the EC arm, there was less intraoperative bleeding, lower risks of delayed haemorrhage and readmission in the HS arm. Post-operative pain scores and use of analgesia were similar. There was earlier return to normal diet and activity in the HS arm compared to the EC arm. More patients in the HS arm recommended using HARMONIC ACE® + 23 cm shears compared to those in the EC arm. This is a non-inferiority study which suggests that the HARMONIC ACE® + 23 cm shears is comparable to monopolar electrocautery in terms of efficacy and post-operative complication rates with better patient satisfaction outcomes. The main weakness of the study is a small study population.
CONCLUSION


This is the first reported study comparing the use of the HARMONIC ACE® + 23 cm shears with monopolar cautery in tonsillectomy. A prospective adequately powered study validated by objective outcome measures would be useful to verify the findings from this pilot study.",2020,"Compared to the EC arm, there was less intraoperative bleeding, lower risks of delayed haemorrhage and readmission in the HS arm.",['20 patients'],"['ACE®\xa0+\xa0shears and monopolar diathermy', 'harmonic scalpel blades', 'ACE®\xa0+\xa023\xa0cm shears (HS) and monopolar electrocautery (EC) tonsillectomy', 'ACE®\xa0+\xa023\xa0cm shears with monopolar cautery in tonsillectomy']","['Post-operative pain scores and use of analgesia', 'intraoperative bleeding, lower risks of delayed haemorrhage and readmission', 'operative time', 'Intraoperative blood loss, pain control, return to normal diet and activity as well as patient satisfaction outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0012002', 'cui_str': 'Diathermy'}, {'cui': 'C0392220', 'cui_str': 'Scalpel'}, {'cui': 'C2948008', 'cui_str': 'Blade'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0007471', 'cui_str': 'Cauterization - action'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0502624,"Compared to the EC arm, there was less intraoperative bleeding, lower risks of delayed haemorrhage and readmission in the HS arm.","[{'ForeName': 'Wei Ming James', 'Initials': 'WMJ', 'LastName': 'Kwek', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore.'}, {'ForeName': 'Shu May Celeste Ann', 'Initials': 'SMCA', 'LastName': 'Chua', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore.'}, {'ForeName': 'Shu Hui', 'Initials': 'SH', 'LastName': 'Xu', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore.'}, {'ForeName': 'Toh Hui Leonard', 'Initials': 'THL', 'LastName': 'Tan', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore.'}, {'ForeName': 'Xin Yong', 'Initials': 'XY', 'LastName': 'Huang', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Loh', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore.'}, {'ForeName': 'Tee Sin', 'Initials': 'TS', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore. Electronic address: lee.tee.sin@singhealth.com.sg.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102568']
1173,32584417,Slicing and dicing small cell lung cancer to improve trial outcomes.,,2020,,[],[],[],[],[],[],,0.0334025,,"[{'ForeName': 'Asrar', 'Initials': 'A', 'LastName': 'AlAhmadi', 'Affiliation': 'Division of Hematology and Oncology, University Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Dowlati', 'Affiliation': 'Division of Hematology and Oncology, University Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, Ohio.'}]",Cancer,['10.1002/cncr.33047']
1174,32446323,Estimating lifetime benefits of comprehensive disease-modifying pharmacological therapies in patients with heart failure with reduced ejection fraction: a comparative analysis of three randomised controlled trials.,"BACKGROUND


Three drug classes (mineralocorticoid receptor antagonists [MRAs], angiotensin receptor-neprilysin inhibitors [ARNIs], and sodium/glucose cotransporter 2 [SGLT2] inhibitors) reduce mortality in patients with heart failure with reduced ejection fraction (HFrEF) beyond conventional therapy consisting of angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) and β blockers. Each class was previously studied with different background therapies and the expected treatment benefits with their combined use are not known. Here, we used data from three previously reported randomised controlled trials to estimate lifetime gains in event-free survival and overall survival with comprehensive therapy versus conventional therapy in patients with chronic HFrEF.
METHODS


In this cross-trial analysis, we estimated treatment effects of comprehensive disease-modifying pharmacological therapy (ARNI, β blocker, MRA, and SGLT2 inhibitor) versus conventional therapy (ACE inhibitor or ARB and β blocker) in patients with chronic HFrEF by making indirect comparisons of three pivotal trials, EMPHASIS-HF (n=2737), PARADIGM-HF (n=8399), and DAPA-HF (n=4744). Our primary endpoint was a composite of cardiovascular death or first hospital admission for heart failure; we also assessed these endpoints individually and assessed all-cause mortality. Assuming these relative treatment effects are consistent over time, we then projected incremental long-term gains in event-free survival and overall survival with comprehensive disease-modifying therapy in the control group of the EMPHASIS-HF trial (ACE inhibitor or ARB and β blocker).
FINDINGS


The hazard ratio (HR) for the imputed aggregate treatment effects of comprehensive disease-modifying therapy versus conventional therapy on the primary endpoint of cardiovascular death or hospital admission for heart failure was 0·38 (95% CI 0·30-0·47). HRs were also favourable for cardiovascular death alone (HR 0·50 [95% CI 0·37-0·67]), hospital admission for heart failure alone (0·32 [0·24-0·43]), and all-cause mortality (0·53 [0·40-0·70]). Treatment with comprehensive disease-modifying pharmacological therapy was estimated to afford 2·7 additional years (for an 80-year-old) to 8·3 additional years (for a 55-year-old) free from cardiovascular death or first hospital admission for heart failure and 1·4 additional years (for an 80-year-old) to 6·3 additional years (for a 55-year-old) of survival compared with conventional therapy.
INTERPRETATION


Among patients with HFrEF, the anticipated aggregate treatment effects of early comprehensive disease-modifying pharmacological therapy are substantial and support the combination use of an ARNI, β blocker, MRA, and SGLT2 inhibitor as a new therapeutic standard.
FUNDING


None.",2020,HRs were also favourable for cardiovascular death alone (HR 0·50 [,"['patients with heart failure with reduced ejection fraction (HFrEF) beyond conventional therapy consisting of', '2·7 additional years (for an 80-year-old) to 8·3 additional years (for a 55-year-old) free from cardiovascular death or first hospital admission for heart failure and 1·4 additional years (for an 80-year-old) to 6·3 additional years (for a 55-year-old) of survival compared with conventional therapy', 'patients with HFrEF', 'patients with heart failure with reduced ejection fraction', 'patients with chronic HFrEF.\nMETHODS', 'patients with chronic HFrEF by making indirect comparisons of three pivotal trials, EMPHASIS-HF (n=2737), PARADIGM-HF (n=8399), and DAPA-HF (n=4744']","['comprehensive disease-modifying pharmacological therapy', 'angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) and β blockers', 'comprehensive disease-modifying pharmacological therapies', 'comprehensive therapy versus conventional therapy', 'comprehensive disease-modifying pharmacological therapy (ARNI, β blocker, MRA, and SGLT2 inhibitor) versus conventional therapy (ACE inhibitor or ARB and β blocker']","['cardiovascular death or hospital admission for heart failure', 'hospital admission for heart failure alone (0·32', 'hazard ratio (HR', 'composite of cardiovascular death or first hospital admission for heart failure', 'cardiovascular death alone (HR 0·50 ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4280934', 'cui_str': 'Reduced ejection fraction co-occurrent and due to chronic heart failure'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0022709', 'cui_str': 'Dipeptidyl carboxypeptidase I'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0243032', 'cui_str': 'Magnetic resonance imaging (MRI) of vessels'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",,0.181843,HRs were also favourable for cardiovascular death alone (HR 0·50 [,"[{'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Cunningham', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Pedro Ferreira', 'Affiliation': ""Université de Lorraine INSERM, Centre d'Investigations Cliniques Plurithématique 1433, INSERM U1116, CHRU de Nancy, F-CRIN INI-CRCT, Nancy, France; Department of Physiology and Cardiothoracic Surgery, University of Porto, Porto, Portugal.""}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Université de Lorraine INSERM, Centre d'Investigations Cliniques Plurithématique 1433, INSERM U1116, CHRU de Nancy, F-CRIN INI-CRCT, Nancy, France.""}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX, USA; Imperial College, London, UK.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Division of Cardiology, David Geffen School of Medicine, University of California, Los Angeles Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: ssolomon@bwh.harvard.edu.""}]","Lancet (London, England)",['10.1016/S0140-6736(20)30748-0']
1175,32466396,Does Post-Activation Performance Enhancement Occur During the Bench Press Exercise under Blood Flow Restriction?,"Background :  The aim of the present study was to evaluate the effects of post-activation performance enhancement (PAPE) during successive sets of the bench press (BP) exercise under blood flow restriction (BFR). Methods :  The study included 10 strength-trained males (age = 29.8 ± 4.6 years; body mass = 94.3 ± 3.6 kg; BP 1-repetition maximum (1RM) = 168.5 ± 26.4 kg). The experiment was performed following a randomized crossover design, where each participant performed two different exercise protocols: under blood flow restriction (BFR) and control test protocol (CONT) without blood flow restriction. During the experimental sessions, the study participants performed 3 sets of 3 repetitions of the BP exercise at 70%1RM with a 5 min rest interval between sets. The differences in peak power output (PP), mean power output (MP), peak bar velocity (PV), and mean bar velocity (MV) between the CONT and BFR conditions were examined using 2-way (condition × set) repeated measures ANOVA. Furthermore, t-test comparisons between conditions were made for the set 2-set 1, set 3-set 1, and set 3-set 2 delta values for all variables. Results :  The post hoc results for condition × set interaction in PP showed a significant increase in set 2 compared to set 1 for BFR ( p  < 0.01) and CONT ( p  = 0.01) conditions, a significant increase in set 3 compared to set 1 for the CONT ( p  = 0.01) condition, as well as a significant decrease in set 3 compared to set 1 for BFR condition occurred ( p  < 0.01). The post hoc results for condition × set interaction in PV showed a significant increase in set 2 compared to set 1 for BFR ( p  < 0.01) and CONT ( p  = 0.01) conditions, a significant increase in set 3 compared to set 1 for CONT ( p  = 0.03) condition, as well as a significant decrease in set 3 compared to set 1 for BFR condition ( p  < 0.01). The t-test comparisons showed significant differences in PP ( p  < 0.01) and PV ( p  = 0.01) for set 3-set 2 delta values between BFR and CONT conditions. Conclusion :  The PAPE effect was analyzed through changes in power output and bar velocity that occurred under both the CONT and BFR conditions. However, the effects of PAPE have different kinetics in successive sets for BFR and for CONT conditions.",2020,The t-test comparisons showed significant differences in PP ( p  < 0.01) and PV ( p  = 0.01) for set 3-set 2 delta values between BFR and CONT conditions.,['10 strength-trained males (age = 29.8 ± 4.6 years; body mass = 94.3 ± 3.6 kg; BP 1-repetition maximum (1RM) = 168.5 ± 26.4 kg'],"['exercise protocols: under blood flow restriction (BFR) and control test protocol (CONT) without blood flow restriction', 'PAPE', 'post-activation performance enhancement (PAPE', 'BP exercise']","['peak power output (PP), mean power output (MP), peak bar velocity (PV), and mean bar velocity (MV) between the CONT and BFR conditions', 'PP', 'BFR condition', 'blood flow restriction (BFR', 'power output and bar velocity']","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1272570', 'cui_str': 'Test control'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",10.0,0.0189799,The t-test comparisons showed significant differences in PP ( p  < 0.01) and PV ( p  = 0.01) for set 3-set 2 delta values between BFR and CONT conditions.,"[{'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Wilk', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Krzysztofik', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Filip', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Szkudlarek', 'Affiliation': 'Department of Physical Pharmacy, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical University of Silesia in Katowice, 40-055 Katowice, Poland.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Lockie', 'Affiliation': 'Center for Sports Performance, Department of Kinesiology, California State University, Fullerton, CA 92831, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Zajac', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17113752']
1176,32466961,Sunitinib Versus Sorafenib as Initial Targeted Therapy for mCC-RCC With Favorable/Intermediate Risk: Multicenter Randomized Trial CROSS-J-RCC.,"PURPOSE


The present study compared the efficacy of sunitinib and sorafenib as first-line treatment of metastatic clear cell renal cell carcinoma (mCC-RCC) with favorable or intermediate Memorial Sloan Kettering Cancer Center (MSKCC) risk.
PATIENTS AND METHODS


Treatment-naive patients with mCC-RCC were randomized to receive open-label sunitinib followed by sorafenib (SU/SO) or sorafenib followed by sunitinib (SO/SU). The primary endpoint was first-line progression-free survival (PFS). The secondary endpoints were total PFS and overall survival (OS).
RESULTS


Of the 124 patients enrolled at 39 institutions from February 2010 to July 2012, 120 were evaluated. The median first-line PFS duration was 8.7 and 7.0 months in the SU/SO and SO/SU groups, respectively (hazard ratio [HR], 0.67; 95% confidence interval [CI], 0.42-1.08). The total PFS and OS were not significantly different between the SU/SO and SO/SU groups (27.8 and 22.6 months; HR, 0.73; 95% CI, 0.428-1.246; and 38.4 and 30.9 months; HR, 0.934; 95% CI, 0.588-1.485, respectively). The subgroup analysis revealed that the total PFS with SU/SO was superior to the total PFS with SO/SU in the patients with favorable MSKCC risk and those with < 5 metastatic sites). SO/SU was superior to SU/SO for patients without previous nephrectomy.
CONCLUSIONS


No statistically significant differences were found in first-line PFS, total PFS, or OS between the 2 treatment arms (ClinicalTrials.gov identifier, NCT01481870).",2020,"No statistically significant differences were found in first-line PFS, total PFS, or OS between the 2 treatment arms (ClinicalTrials.gov identifier, NCT01481870).","['Treatment-naive patients with mCC-RCC', 'mCC-RCC With Favorable/Intermediate Risk', 'metastatic clear cell renal cell carcinoma (mCC-RCC) with favorable or intermediate Memorial Sloan Kettering Cancer Center (MSKCC) risk', 'patients without previous nephrectomy', '124 patients enrolled at 39 institutions from February 2010 to July 2012, 120 were evaluated']","['open-label sunitinib followed by sorafenib (SU/SO) or sorafenib followed by sunitinib (SO/SU', 'sunitinib and sorafenib', 'Sunitinib Versus Sorafenib']","['total PFS and overall survival (OS', 'median first-line PFS duration', 'first-line progression-free survival (PFS', 'first-line PFS, total PFS, or OS', 'total PFS and OS']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0279702', 'cui_str': 'Clear cell carcinoma of kidney'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0027695', 'cui_str': 'Kidney excision'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",124.0,0.0953987,"No statistically significant differences were found in first-line PFS, total PFS, or OS between the 2 treatment arms (ClinicalTrials.gov identifier, NCT01481870).","[{'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Department of Urology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan. Electronic address: ytomita@med.niigata-u.ac.jp.'}, {'ForeName': 'Sei', 'Initials': 'S', 'LastName': 'Naito', 'Affiliation': 'Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Sassa', 'Affiliation': 'Department of Urology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Takahashi', 'Affiliation': 'Department of Urology, Hakodate Goryoukaku Hospital, Hokkaido, Japan.'}, {'ForeName': 'Tsunenori', 'Initials': 'T', 'LastName': 'Kondo', 'Affiliation': ""Department of Urology, Tokyo Women's Medical University Medical Center East, Tokyo, Japan.""}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Koie', 'Affiliation': 'Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan; Department of Urology, Gifu University School of Medicine, Seki, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Obara', 'Affiliation': 'Department of Urology, Iwate Medical University, Morioka, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Urology, Okayama University Graduate School of Medicine, Okayama, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Teishima', 'Affiliation': 'Department of Urology, Graduate School of Biomedical Health Science, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Department of Urology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Hideyasu', 'Initials': 'H', 'LastName': 'Matsuyama', 'Affiliation': 'Department of Urology, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Ueda', 'Affiliation': 'Department of Urology, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Urology, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kishida', 'Affiliation': 'Department of Urology, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Ryoichi', 'Initials': 'R', 'LastName': 'Shiroki', 'Affiliation': 'Department of Urology, Fujita Health University School of Medicine, Toyoake, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Saika', 'Affiliation': 'Department of Urology, Ehime University, Matsuyama, Japan.'}, {'ForeName': 'Nobuo', 'Initials': 'N', 'LastName': 'Shinohara', 'Affiliation': 'Department of Urology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Mototsugu', 'Initials': 'M', 'LastName': 'Oya', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiro-Omi', 'Initials': 'HO', 'LastName': 'Kanayama', 'Affiliation': 'Department of Urology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}]",Clinical genitourinary cancer,['10.1016/j.clgc.2020.01.001']
1177,32471404,Effectiveness of a theory-based back care intervention on spine-related behavior among pupils: a school-based randomised controlled trial (T-Bak study).,"BACKGROUND


Children's health and welfare have a special place in research and policy in many countries. One of the most important concerns is the increasing rate of backache in children due to many of behavioral risk factors. The aim of this study was to evaluate the effectiveness of an educational program on promoting back-related behavior as well as knowledge, skills, beliefs, and self-efficacy among fifth grade girls.
METHODS


The theory-based back care (T-Bak) study was a school-based randomised controlled trial (RCT) that assessed the effectiveness of developing a back care training program based on the social cognitive theory (SCT). A total of 104 schoolchildren aged 11 ± 1.0 years were assigned to intervention (n = 52) and control (n = 52) groups. The intervention group received six sessions training on proper lifting and carrying techniques, having proper posture during daily activities, and correct backpack wearing techniques with a 1-week interval while the control group received nothing. Then, the two groups were assessed for knowledge, skills, self-efficacy, beliefs, and behavior at four points in time: baseline, immediate, three and six-months post-intervention. The changes of the outcomes investigated using univariate repeated measures analysis of variance. Partial eta squared measure (η p 2 ) was used to calculate effect sizes.
RESULTS


A positive change was found for the intervention group back-related behavior from baseline to immediate post-intervention and follow-ups (F = 78.865, p < 0.001, η p 2  = 0.22). Overall there were 36.4% improvement for knowledge (η p 2  = 0.21), 53.2% for the skills (η p 2  = 0.25), 19.5% for the self-efficacy (η p 2  = 0.11), and 25.6% for the beliefs (η p 2  = 0.14) scores from baseline to 6 months' follow-up assessments among the intervention group (p < 0.001). The results also showed a significant interaction effect between group and time.
CONCLUSION


The T-Bak intervention was effective in improving back-related behavior in pupils. It is now available and could be evaluated further in back-care related studies.
TRIAL REGISTRATION


Current Controlled Trials IRCT20180528039885N1, 30th Oct 2018, 'Prospectively registered'. https://www.irct.ir/trial/31534.",2020,"A positive change was found for the intervention group back-related behavior from baseline to immediate post-intervention and follow-ups (F = 78.865, p < 0.001, η p 2  = 0.22).","['104 schoolchildren aged 11\u2009±\u20091.0\u2009years', 'spine-related behavior among pupils']","['theory-based back care intervention', 'six sessions training on proper lifting and carrying techniques, having proper posture during daily activities, and correct backpack wearing techniques with a 1-week interval while the control group received nothing', 'educational program']","['rate of backache', 'knowledge, skills, self-efficacy, beliefs, and behavior', 'knowledge', 'knowledge, skills, beliefs, and self-efficacy']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0204750', 'cui_str': 'Special back care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",104.0,0.0707787,"A positive change was found for the intervention group back-related behavior from baseline to immediate post-intervention and follow-ups (F = 78.865, p < 0.001, η p 2  = 0.22).","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Akbari-Chehrehbargh', 'Affiliation': 'Department of Health Education, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Sedigheh Sadat', 'Initials': 'SS', 'LastName': 'Tavafian', 'Affiliation': 'Department of Health Education, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran. Tavafian@modares.ac.ir.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Montazeri', 'Affiliation': 'Health Metrics Research Center, Iranian Institutes for Health Sciences Research, ACECR, Tehran, Iran. montazeri@acecr.ac.ir.'}]",BMC public health,['10.1186/s12889-020-08566-z']
1178,32473556,Functional training with blood occlusion influences muscle quality indices in older adults.,"OBJECTIVES


This study aimed to determine if functional training with blood flow restriction (BFR) has a greater effect on muscle quality indices and performance of older men when compared to functional training without BFR.
MATERIALS AND METHODS


Thirty men (67.7 ± 5.8 years) were randomly assigned to one of the following three groups: functional training (FT), functional training with blood flow restriction (FTBFR), and control (C). Participants in both experimental groups trained three sessions per week for six weeks. The training program included eleven body exercises, which were performed in 2-4 sets of 10 repetitions. FTBFR group wore pneumatic cuffs on their extremities that begun with 50 % of estimated arterial occlusion pressure and increased by 10 % every 2 weeks. Before and after the intervention period, subjects completed a series of tests to assess physical performances along with changes serum muscle quality indices.
RESULTS


A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05). In addition, the levels of CAF in FTBFR group was significantly lower compared to control group. Moreover, the circulatory levels of N-terminal propeptide type III collagen (P3NP) were reduced significantly in FT and C groups (p ≤ 0.05) but did not statistically differ from baseline in FTBFR group (p > 0.05). These changes were accompanied by significant improvements in dynamic strength, flexibility, static, and dynamic balance in both training groups (p ≤ 0.01).
CONCLUSIONS


The finding showed greater improvements in muscle quality indices and functional performance of older men when exercises performed with BFR.",2020,A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05).,"['Thirty men (67.7\u202f±\u202f5.8 years', 'older adults', 'older men']","['Functional training with blood occlusion', 'FTBFR group wore pneumatic cuffs', 'functional training with blood flow restriction (BFR', 'functional training (FT), functional training with blood flow restriction (FTBFR), and control (C']","['circulatory levels of N-terminal propeptide type III collagen (P3NP', 'dynamic strength, flexibility, static, and dynamic balance', 'serum C-terminal Agrin Fragment (CAF) levels', 'arterial occlusion pressure', 'muscle quality indices and functional performance', 'levels of CAF']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0009332', 'cui_str': 'Collagen type III'}, {'cui': 'C0072054', 'cui_str': 'procollagen Type III-N-terminal peptide'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4077009', 'cui_str': 'C-terminal agrin fragment'}, {'cui': 'C0264995', 'cui_str': 'Occlusion of artery'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0143913,A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05).,"[{'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Bigdeli', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Mohammad Hasan', 'Initials': 'MH', 'LastName': 'Dehghaniyan', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Amani-Shalamzari', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran. Electronic address: amani_sadegh@khu.ac.ir.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rajabi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Gahreman', 'Affiliation': 'College of Health and Human Sciences, Charles Darwin University, Darwin, Northern Territory, Australia.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104110']
1179,32559392,The Effect of Motivational Interviewing on Self-Efficacy and Continuation of Exclusive Breastfeeding Rates: A Quasi-Experimental Study.,"Background:  Self-efficacy is a decisive psychological and motivational factor in maintaining exclusive breastfeeding (EBF). The aim of this study was to explore the impact of motivational interviewing (MI) on EBF self-efficacy and EBF in primiparous women.  Materials and Methods:  This quasi-experimental study was conducted on 140 primiparous women admitted to a number of comprehensive health centers in Zahedan in 2019. The health centers were determined through multistage random sampling, and the subjects were selected from each center using convenience sampling. The selected women were equally divided into the intervention and control groups. The two groups took the pretest by filling out a demographic questionnaire and a breastfeeding self-efficacy questionnaire. The intervention group attended four 45- to 60-minute MI sessions on breastfeeding. The EBF continuation sheet and the breastfeeding self-efficacy questionnaire were filled out 6 months postpartum. Data were analyzed in SPSS 22 using paired  t -test, independent  t -test, chi-square test, and covariance analysis.  Results:  Based on the results, the mean and standard deviation of the number of EBF days were significantly higher in the intervention group (137.68 ± 65.50) compared with that of the control group (99.51 ± 80.62). In addition, the mean score of breastfeeding self-efficacy after MI was significantly different between the two groups ( p  = 0.0001).  Conclusion:  Because of the significantly positive impact of MI on enhancing EBF self-efficacy and continuation, it is recommended to integrate this counseling strategy into the care programs designed for women in pregnancy and even postpartum period.",2020,"In addition, the mean score of breastfeeding self-efficacy after MI was significantly different between the two groups ( p  = 0.0001).  ","['primiparous women', '140 primiparous women admitted to a number of comprehensive health centers in Zahedan in 2019']","['motivational interviewing (MI', 'Motivational Interviewing']","['Self-Efficacy and Continuation of Exclusive Breastfeeding Rates', 'breastfeeding self-efficacy questionnaire', 'EBF self-efficacy and EBF', 'mean score of breastfeeding self-efficacy after MI', 'EBF self-efficacy and continuation', 'mean and standard deviation of the number of EBF days']","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0475309', 'cui_str': 'Health center'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",140.0,0.0167012,"In addition, the mean score of breastfeeding self-efficacy after MI was significantly different between the two groups ( p  = 0.0001).  ","[{'ForeName': 'Homeyra', 'Initials': 'H', 'LastName': 'Naroee', 'Affiliation': 'Department of Midwifery, Nursing and Midwifery School, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Marzihe', 'Initials': 'M', 'LastName': 'Rakhshkhorshid', 'Affiliation': 'Department of Midwifery, Nursing and Midwifery School, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Shakiba', 'Affiliation': 'Department of Psychiatry, Medicine School, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Navidian', 'Affiliation': 'Department of Counseling, Pregnancy Health Research Center, Nursing and Midwifery School, Zahedan University of Medical Sciences, Zahedan, Iran.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2019.0252']
1180,32561426,Recombinant human thrombopoietin in critically ill patients with sepsis-associated thrombocytopenia: A clinical study.,"BACKGROUND


Sepsis causes varying degrees of thrombocytopenia that are closely related to the likelihood of patient mortality. This study analysed the effect of recombinant human thrombopoietin (rhTPO) on the platelet count in critically ill patients with sepsis-associated thrombocytopenia and provided a reference for its treatment.
MATERIAL/METHODS


The study was a retrospective analysis of the clinical data of patients. Patients were divided into an rhTPO group and control group according to rhTPO use during treatment. Demographical and clinical data (age, sex, history of hypertension, diabetes, platelet counts, mortality rate, etc.) of the patients were collected and analysed using statistical software; p < 0.05 was considered statistically significant.
RESULTS


Of 213 patients, 84 constituted the rhTPO group and 129 constituted the control group. The increase in platelet counts was significantly higher in the rhTPO group than in the control group on the third day (43.01 ± 18.23 × 10 9 /L vs. 36.31 ± 14.17 × 10 9 /L, p = 0.003), fifth day (71.51 ± 39.59 × 10 9 /L vs. 42.95 ± 20.48 × 10 9 /L, p < 0.001) and seventh day (115.36 ± 69.41 × 10 9 /L vs. 62.54 ± 42.70 × 10 9 /L, p < 0.001). Further statistical analysis of the data of patients with platelet counts ≤30 × 10 9 /L and >30 × 10 9 /L and APACHE II scores >15 and ≤15 at the time of diagnosis showed that the increase in platelet counts in the rhTPO group was greater. There was no significant between-group difference in volume of platelet transfusions (rhTPO group 15.42 ± 17.20 vs. control group 10.93 ± 17.48, p = 0.068). The cost of ICU treatment in patients with rhTPO was higher (RMB 126,936.21 ± 86,548.27 vs. 101,685.28 ± 77,291.75, p = 0.027); however, the ICU stay time was shorter (9.20 ± 5.38 vs. 10.88 ± 6.82, p = 0.047). There was no significant difference in 28-day mortality (rhTPO group: 25.0% vs. control group: 34.1%, p = 0.158) between the two groups.
CONCLUSION


For patients with severe thrombocytopenia or severe sepsis, rhTPO was efficacious in increasing their platelet counts, resulting in a shorter ICU stay time.",2020,The increase in platelet counts was significantly higher in the rhTPO group than in the control group on the third day (43.01±18.23×10 9,"['patients with severe thrombocytopenia or patients with severe sepsis', 'patients with platelet counts', 'critically ill patients with sepsis-associated thrombocytopenia and provided a reference for its treatment', '213 patients', '84 patients constituted the rhTPO group and 129 constituted the control group', 'critically ill patients with sepsis-associated thrombocytopenia', '≤30×10 9']","['recombinant human thrombopoietin (rhTPO', 'Recombinant human thrombopoietin', 'rhTPO']","['ICU stay time', 'platelet counts', 'volume of platelet transfusions', 'cost of ICU treatment', '28-days mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C1719672', 'cui_str': 'Severe Sepsis'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040052', 'cui_str': 'Thrombopoietin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040052', 'cui_str': 'Thrombopoietin'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0086818', 'cui_str': 'Platelet transfusion'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",213.0,0.0258731,The increase in platelet counts was significantly higher in the rhTPO group than in the control group on the third day (43.01±18.23×10 9,"[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Critical Care Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Jin', 'Affiliation': ""Emergency Department, Xi'an Aerospace General Hospital, Xi'an, China.""}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': ""Department of Critical Care Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Critical Care Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. Electronic address: wangxuejd2008@126.com.""}, {'ForeName': 'Litao', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': ""Department of Critical Care Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. Electronic address: glt2002@xjtu.edu.cn.""}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.06.045']
1181,32561466,A randomized clinical trial of a collaborative home-based diabetes intervention to reduce emergency department visits and hospitalizations in black individuals with diabetes.,"The prevalence of diabetes mellitus (DM) in black individuals (blacks) is twice that of white individuals (whites), and blacks are more likely to have worse glycemic control, less optimal medication regimens, and higher levels of mistrust in the medical system. These three factors account for higher rates of acute medical care use in blacks with DM. To address this disparity, we developed DM I-TEAM (Diabetes Interprofessional Team to Enhance Adherence to Medical Care), a home-based multidisciplinary behavioral intervention that integrates care from a community health worker (CHW), the participant's primary care physician (PCP), a DM nurse educator, and a clinical pharmacist. Treatment is delivered during 9 sessions over 1 year, and includes diabetes education and goal setting, telehealth visits with participants' PCP and a DM nurse educator, and comprehensive medication reviews by a pharmacist. We describe the rationale and methods for a randomized controlled trial to test the efficacy of DM I-TEAM to reduce emergency department (ED) visits and hospitalizations. We are enrolling 200 blacks with DM during an ED visit. Participants are randomized to DM I-TEAM or Usual Medical Care (UMC). Follow-up assessments are conducted at 6 and 12 months. The primary outcome is the number of ED visits and hospitalizations over 12 months, and is measured by participant self-report and medical record review. Secondary outcomes include hemoglobin A1c (HbA1c), number of potentially inappropriate medications (PIMs), and trust in health care.",2020,"The prevalence of diabetes mellitus (DM) in black individuals (blacks) is twice that of white individuals (whites), and blacks are more likely to have worse glycemic control, less optimal medication regimens, and higher levels of mistrust in the medical system.","['200 blacks with DM during an ED visit', 'blacks with DM', 'black individuals (blacks', 'black individuals with diabetes']","['DM I-TEAM', 'collaborative home-based diabetes intervention', 'DM I-TEAM or Usual Medical Care (UMC']","['hemoglobin A1c (HbA1c), number of potentially inappropriate medications (PIMs), and trust in health care', 'emergency department (ED) visits and hospitalizations', 'prevalence of diabetes mellitus (DM', 'number of ED visits and hospitalizations over 12\u202fmonths, and is measured by participant self-report and medical record review']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0730229', 'cui_str': 'Medical records review'}]",200.0,0.0803291,"The prevalence of diabetes mellitus (DM) in black individuals (blacks) is twice that of white individuals (whites), and blacks are more likely to have worse glycemic control, less optimal medication regimens, and higher levels of mistrust in the medical system.","[{'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Casten', 'Affiliation': 'Department of Psychiatry and Human Behavior, Sidney Kimmel Medical College at Thomas, Jefferson University, United States of America. Electronic address: Robin.Casten@Jefferson.edu.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Rovner', 'Affiliation': 'Departments of Neurology, Psychiatry, and Ophthalmology, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Anna Marie', 'Initials': 'AM', 'LastName': 'Chang', 'Affiliation': 'Department of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Judd E', 'Initials': 'JE', 'LastName': 'Hollander', 'Affiliation': 'Department of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Kelley', 'Affiliation': 'Department of Neurology, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Leiby', 'Affiliation': 'Division of Biostatistics, Department of Pharmacology and Experimental Therapeutics, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Ginah', 'Initials': 'G', 'LastName': 'Nightingale', 'Affiliation': 'Jefferson College of Pharmacy at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pizzi', 'Affiliation': 'Center for Health Outcomes, Policy, and Economics, Ernest Mario School of Pharmacy, Rutgers University, United States of America.'}, {'ForeName': 'Neva', 'Initials': 'N', 'LastName': 'White', 'Affiliation': 'Center for Urban Health, Thomas Jefferson University Hospital, United States of America.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Rising', 'Affiliation': 'Department of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106069']
1182,32561467,A randomized comparison trial of culturally adapted HIV prevention approaches for Native Americans reducing trauma symptoms versus substance misuse: The Healing Seasons protocol.,"Native Americans (NA) experience interrelated risks of trauma exposure, substance use, and HIV risk behaviors that put them at increased risk for HIV infection. Despite these known risk factors, there are very few published randomized trials testing interventions to reduce trauma-related symptoms and substance misuse among NA.
METHODS


The Healing Seasons study is a randomized comparsion trial of two counseling strategies, Narrative Exposure Therapy (NET) addressing PTSD or Motivational interviewing with cognitive behavioral therapy skills training (MIST) addressing substance misuse as a means to prevent HIV among NA. Using a community-based participatory research approach, we adapted both evidence-based interventions to be specific to the risk contexts and realities of NA and to include psychoeducational and skill-building components that include cultural-specific stories, virtues, and traditional treatment strategies. Participants, 16 years and older, were recruited from a Pacific Northwest tribal community, screened over the phone, enrolled in person, and randomized in equal numbers to NET or MIST. We stratified by age (16-29 years and 30 or older) and gender (male or female identified) to ensure balance between treatment arms. The primary outcomes were number of sex partners and frequency of sexual acts (with and without condoms), sex under the influence of substances, frequency of substance use, and PTSD severity.
DISCUSSION


Behavioral interventions for NA are needed to prevent HIV risk behaviors when faced with trauma symptoms and substance misuse. This study will provide evidence to determine feasibility and efficacy of addressing related risk factors as part of counseling-based HIV prevention intervention to reduce sexual risk among this population.
TRIAL REGISTRATION


ClinicalTrials.gov number, NCT03112369, registered April 12, 2017.",2020,"Using a community-based participatory research approach, we adapted both evidence-based interventions to be specific to the risk contexts and realities of NA and to include psychoeducational and skill-building components that include cultural-specific stories, virtues, and traditional treatment strategies.","['Native Americans reducing trauma symptoms versus substance misuse', 'We stratified by age (16-29\u202fyears and 30 or older) and gender (male or female identified', 'Participants, 16\u202fyears and older, were recruited from a Pacific Northwest tribal community, screened over the phone, enrolled in person']","['NET or MIST', 'culturally adapted HIV prevention approaches', 'Narrative Exposure Therapy (NET) addressing PTSD or Motivational interviewing with cognitive behavioral therapy skills training (MIST', 'counseling-based HIV prevention intervention']","['number of sex partners and frequency of sexual acts (with and without condoms), sex under the influence of substances, frequency of substance use, and PTSD severity', 'HIV risk behaviors']","[{'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030170', 'cui_str': 'Pacific Northwest'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]",,0.0757073,"Using a community-based participatory research approach, we adapted both evidence-based interventions to be specific to the risk contexts and realities of NA and to include psychoeducational and skill-building components that include cultural-specific stories, virtues, and traditional treatment strategies.","[{'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Pearson', 'Affiliation': 'Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA. Electronic address: pearsonc@uw.edu.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kaysen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Huh', 'Affiliation': 'Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bedard-Gillgan', 'Affiliation': 'Department of Psychiatry, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Walker', 'Affiliation': 'Innovative Programs Research Group, School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Marin', 'Affiliation': 'Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Saluskin', 'Affiliation': 'Yakama Nation Behavioral Health Services, Toppenish, WA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106070']
1183,32562806,Impact of health warning labels on snack selection: An online experimental study.,"Excessive consumption of energy-dense food increases the risk of obesity, which in turn increases the risk of non-communicable diseases, including heart disease, type 2 diabetes and most non-smoking-related cancers. Health warning labels (HWLs) that communicate the adverse health consequences of excess energy consumption could reduce intake of energy-dense foods. The aim of the current study was to estimate the impact on selection of energy-dense snacks of (a) image-and-text HWLs (b) text-only HWLs and (c) calorie information. In a between-subjects, 3 (HWL: image-and-text, text-only, no label) x 2 (calorie information: present, absent), factorial experimental design, participants (N = 4134) were randomised to view a selection of energy-dense and non-energy-dense snacks with one of five label types or no label. The primary outcome was the proportion of participants selecting an energy-dense snack in a hypothetical vending machine task. The proportion of participants selecting an energy-dense snack was reduced in all label groups, relative to the no label group (no label: 59%; calories only: 54%; text-only HWL: 48%; text-only HWL with calories: 44%; image-and-text HWL: 37%; image-and-text HWL with calories: 38%). Compared to the no label group, participants were least likely to select an energy-dense snack in the image-and-text HWL group (OR = 0.46, 95%CI = 0.40, 0.54, p < 0.001). Health warning labels - particularly those including an image and text - have the potential to reduce selection of energy-dense snacks in an online setting. Their impact on selection and consumption in real-world settings awaits testing.",2020,"The proportion of participants selecting an energy-dense snack was reduced in all label groups, relative to the no label group (no label: 59%; calories only: 54%; text-only HWL: 48%; text-only HWL with calories: 44%; image-and-text HWL: 37%; image-and-text HWL with calories: 38%).","['participants (N\u202f=\u202f4,134', 'snack selection']","['energy-dense snacks of (a) image-and-text HWLs (b) text-only HWLs and (c) calorie information', 'health warning labels', 'energy-dense and non-energy-dense snacks with one of five label types or no label']","['proportion of participants selecting an energy-dense snack', 'proportion of participants selecting an energy-dense snack in a hypothetical vending machine task']","[{'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}]","[{'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0336779', 'cui_str': 'Machine'}]",4134.0,0.0769476,"The proportion of participants selecting an energy-dense snack was reduced in all label groups, relative to the no label group (no label: 59%; calories only: 54%; text-only HWL: 48%; text-only HWL with calories: 44%; image-and-text HWL: 37%; image-and-text HWL with calories: 38%).","[{'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Clarke', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK. Electronic address: ncc42@medschl.cam.ac.uk.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Pechey', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Mantzari', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Anna K M', 'Initials': 'AKM', 'LastName': 'Blackwell', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'De-Loyde', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Morris', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Munafò', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Marteau', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Hollands', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}]",Appetite,['10.1016/j.appet.2020.104744']
1184,32568433,Alterations in Functional Connectivity During Different Phases of the Triggered Migraine Attack.,"OBJECTIVE


To understand the changes in functional connectivity between brain areas of potential importance in migraine during different phases of the attack.
BACKGROUND


Migraine is a symptomatically heterogeneous disorder. Understanding the possible changes in brain function and, therefore, neurobiology during different phases of the migraine attack is important in developing disease biomarkers and advancing therapeutics.
DESIGN


Randomized, double‐blind, placebo‐controlled, multi‐visit experimental study.
METHODS


Subjects aged 18‐50 years with migraine with and without aura (≤22 headache days per month) were recruited from across the UK using advertising, from both population and hospital clinic samples (n  = 53). Consented subjects were randomized to a 0.5 µg/kg/min nitroglycerin infusion or to placebo over 20 minutes across different study visits, during the period February 2015‐July 2017.* All subjects were exposed to a nitroglycerin infusion at least on 1 occasion at screening.** For those subjects who consented to participate in imaging visits (n  = 25), structural T1, T2 and FLAIR sequences and resting state blood oxygen level dependant contrast (rsBOLD) time series, using a multiecho EPI sequence, were conducted over 30‐40 minutes at baseline and rsBOLD during premonitory symptoms and migraine headache on a 3T General Electric MR750 MRI scanner. For the placebo visit, the imaging was conducted at the same times following infusion in the absence of symptoms.
RESULTS


Montreal Neurological Institute (MNI) coordinates were used to characterize identified brain areas of connectivity change. Using repeated measures ANOVA models with time (visit number) and trigger substance (nitroglycerin/placebo) as factors, significant positive functional coupling was found between the thalami bilaterally and the right precuneus and cuneus regions during the nitroglycerin‐triggered premonitory phase (T  = 3.23, peak connectivity change at [−6, −68, 40] for left thalamus, P  = 0.012 and [−4, −68, 40] for right thalamus, P  = 0.019). The nitroglycerin‐triggered premonitory phase was associated with a change in the direction of connectivity from positive to negative between the pons and the limbic lobe (T  = 3.47, peak connectivity change at [2, 8, 50], P  < 0.001). The headache phase of the nitroglycerin‐triggered migraine attack was associated with ongoing negative functional coupling between the pons and the cingulate and frontal cortices, and positive functional coupling between the pons and the cerebellar tonsils and medulla (T  = 3.47, peak connectivity change at [−8, −52, −58], P  = 0.007).
CONCLUSIONS


Understanding the functional reorganization between subcortical and cortical brain areas in different phases of the migraine attack provides novel insights into the abnormal sensory processing and integration during migraine, as well as functional correlation with clinical symptoms displayed during each phase. [*Correction added on July 22, 2020 after first online publication: This sentence was revised from, ""Consented subjects had a 0.5 μg/kg/min nitroglycerin infusion…"".] [**Correction added on July 22, 2020 after first online publication: This sentence was revised from, ""… at least on 1 occasion at screening.""].",2020,"The headache phase of the nitroglycerin-triggered migraine attack was associated with ongoing negative functional coupling between the pons and the cingulate and frontal cortices, and positive functional coupling between the pons and the cerebellar tonsils and medulla (T = 3.47, peak connectivity change at [-8, -52, -58], P = .007).
","['Montreal Neurological Institute (MNI', 'Subjects aged 18-50\xa0years with migraine with and without aura (≤22 headache days per month) were recruited from across the UK using advertising, from both population and hospital clinic samples (n\xa0=\xa053']","['substance (nitroglycerin/placebo', 'nitroglycerin infusion or to placebo', 'nitroglycerin', 'placebo']","['Functional Connectivity', 'positive functional coupling', 'structural T1, T2 and FLAIR sequences and resting state blood oxygen level']","[{'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0236018', 'cui_str': 'Aura'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C0001690', 'cui_str': 'Advertising as Topic'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0587906', 'cui_str': 'Hospital clinic'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.063712,"The headache phase of the nitroglycerin-triggered migraine attack was associated with ongoing negative functional coupling between the pons and the cingulate and frontal cortices, and positive functional coupling between the pons and the cerebellar tonsils and medulla (T = 3.47, peak connectivity change at [-8, -52, -58], P = .007).
","[{'ForeName': 'Nazia', 'Initials': 'N', 'LastName': 'Karsan', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Pyari R', 'Initials': 'PR', 'LastName': 'Bose', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': ""O'Daly"", 'Affiliation': ""Department of Neuroimaging, Centre for Neuroimaging Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Fernando O', 'Initials': 'FO', 'LastName': 'Zelaya', 'Affiliation': ""Department of Neuroimaging, Centre for Neuroimaging Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",Headache,['10.1111/head.13865']
1185,32568447,Thematic analysis of acceptability and fidelity of engagement for behaviour change interventions: The Let's Move It intervention interview study.,"OBJECTIVES


Intervention participants' responses to and engagement with interventions are a key intermediate step between interventions and intended outcomes. The aim of this study was to qualitatively investigate crucial aspects of engagement, namely acceptability (experienced cognitive and emotional responses to the intervention), receipt (comprehension of intervention content), and skill enactment (skill performance in target settings), within the Let's Move It, a multi-component school-based physical activity intervention.
DESIGN


A longitudinal qualitative study embedded in a cluster-randomized trial, with individual interviews of purposefully sampled intervention participants immediately post-intervention (n = 21) and at 14 months (n = 14).
METHODS


Semi-structured interviews were analysed using thematic analysis. Abductive coding process was taken to identify categories for themes.
RESULTS


The analysis resulted in 12 themes and 18 subthemes. Overall, participants reported perceived effectiveness of and affective attitude towards the intervention (acceptability) and understood the main messages and skills (receipt). For example, findings indicated comprehension of the non-judgemental nature and choice-providing messages of the intervention underpinned by self-determination theory. Despite reporting understanding how and why to perform the skills, not using them was a highlighted theme (skill enactment), particularly for self-regulatory techniques such as planning. Friends' role as key self-motivation technique was a prevalent theme. In the within-individual analysis, three different engager types were identified: positive, ambivalent, and negative.
CONCLUSION


Identifying misunderstandings and difficulties in skill acquisition can help interpret main trial outcomes and inform further intervention optimization. This study provides an example of how to use thematic analysis to assess acceptability, receipt, and enactment in interventions.",2020,"Overall, participants reported perceived effectiveness of and affective attitude towards the intervention (acceptability) and understood the main messages and skills (receipt).",[],[],"['acceptability and fidelity of engagement for behaviour change interventions', 'effectiveness of and affective attitude towards the intervention (acceptability) and understood the main messages and skills (receipt']",[],[],"[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",21.0,0.0465529,"Overall, participants reported perceived effectiveness of and affective attitude towards the intervention (acceptability) and understood the main messages and skills (receipt).","[{'ForeName': 'Minttu', 'Initials': 'M', 'LastName': 'Palsola', 'Affiliation': 'Faculty of Social Sciences, University of Helsinki, Finland.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Renko', 'Affiliation': 'Faculty of Social Sciences, University of Helsinki, Finland.'}, {'ForeName': 'Katri', 'Initials': 'K', 'LastName': 'Kostamo', 'Affiliation': 'Faculty of Social Sciences, University of Helsinki, Finland.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Lorencatto', 'Affiliation': 'Centre for Behaviour Change, University College London, UK.'}, {'ForeName': 'Nelli', 'Initials': 'N', 'LastName': 'Hankonen', 'Affiliation': 'Faculty of Social Sciences, University of Helsinki, Finland.'}]",British journal of health psychology,['10.1111/bjhp.12433']
1186,32565123,An acute bout of swimming increases post-exercise energy intake in young healthy men and women.,"Single bouts of land-based exercise (for example, walking, running, cycling) do not typically alter post-exercise energy intake on the day of exercise. However, anecdotal and preliminary empirical evidence suggests that swimming may increase appetite and energy intake. This study compared the acute effects of swimming on appetite, energy intake, and food preference and reward, versus exertion-matched cycling and a resting control. Thirty-two men (n = 17; mean ± SD age 24 ± 2 years, body mass index [BMI] 25.0 ± 2.6 kg/m 2 ) and women (n = 15; age 22 ± 3 years, BMI 22.8 ± 2.3 kg/m 2 ) completed three experimental trials (swimming, cycling, control) in a randomised, crossover design. The exercise trials involved 60-min of 'hard' exercise (self-selected rating of perceived exertion: 15) performed 90-min after a standardised breakfast. Food preference and reward were assessed via the Leeds Food Preference Questionnaire 15-min after exercise, whilst ad libitum energy intake was determined 30-min after exercise. The control trial involved identical procedures except no exercise was performed. Compared with control (3259 ± 1265 kJ), swimming increased ad libitum energy intake (3857 ± 1611 kJ; ES = 0.47, 95% CI of the mean difference between trials 185, 1010 kJ, P = 0.005); the magnitude of increase was smaller after cycling (3652 ± 1619 kJ; ES = 0.31, 95% CI -21, 805 kJ, P = 0.062). Ad libitum energy intake was similar between swimming and cycling (ES = 0.16, 95% CI -207, 618 kJ, P = 0.324). This effect was consistent across sexes and unrelated to food preference and reward which were similar after swimming and cycling compared with control. This study has identified an orexigenic effect of swimming. Further research is needed to identify the responsible mechanism(s), including the relevance of water immersion and water temperature per se.",2020,This effect was consistent across sexes and unrelated to food preference and reward which were similar after swimming and cycling compared with control.,"['young healthy men and women', 'Thirty-two men (n\u202f=\u202f17; mean\u202f±\u202fSD age 24\u202f±\u202f2 years, body mass index [BMI] 25.0\u202f±\u202f2.6\u202fkg/m 2 ) and women (n\u202f=\u202f15', 'age 22\u202f±\u202f3 years, BMI 22.8\u202f±\u202f2.3\u202fkg/m 2 ']","[""60-min of 'hard' exercise (self-selected rating of perceived exertion: 15) performed 90-min after a standardised breakfast"", 'Single bouts of land-based exercise']","['appetite, energy intake, and food preference and reward, versus exertion-matched cycling', 'Ad libitum energy intake', 'appetite and energy intake']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517633', 'cui_str': '2.6'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0016483', 'cui_str': 'Food Preferences'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]",,0.135485,This effect was consistent across sexes and unrelated to food preference and reward which were similar after swimming and cycling compared with control.,"[{'ForeName': 'Alice E', 'Initials': 'AE', 'LastName': 'Thackray', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: A.E.Thackray@lboro.ac.uk.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Willis', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: S.Willis2@lboro.ac.uk.'}, {'ForeName': 'Aron P', 'Initials': 'AP', 'LastName': 'Sherry', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: A.P.Sherry@lboro.ac.uk.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Clayton', 'Affiliation': 'School of Science and Technology, Nottingham Trent University, UK. Electronic address: David.Clayton@ntu.ac.uk.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Broom', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, Coventry University, UK. Electronic address: ad5173@coventry.ac.uk.'}, {'ForeName': 'Mayada', 'Initials': 'M', 'LastName': 'Demashkieh', 'Affiliation': 'Department of Physical Education and Sport Science, Nanyang Technological University, Singapore. Electronic address: Mayada.Demashkieh@nie.edu.sg.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Sargeant', 'Affiliation': 'National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK; Diabetes Research Centre, University of Leicester, UK. Electronic address: js928@leicester.ac.uk.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'James', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK. Electronic address: L.James@lboro.ac.uk.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'Faculty of Medicine and Health, University of Leeds, UK. Electronic address: G.S.Finlayson@leeds.ac.uk.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stensel', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: D.J.Stensel@lboro.ac.uk.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'King', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: j.a.king@lboro.ac.uk.'}]",Appetite,['10.1016/j.appet.2020.104785']
1187,32573910,Early changes in bone turnover and inflammatory biomarkers and clinically significant bone mineral density loss over 48 weeks among HIV-infected patients with virological failure of a standard first-line antiretroviral therapy regimen in the SECOND-LINE study.,"OBJECTIVES


We assessed whether changes at week 12 in markers of bone turnover, inflammation, and immune activation were associated with clinically important (≥ 5%) bone mineral density (BMD) loss from baseline to week 48 at the proximal femur (hip) and lumbar spine in the SECOND-LINE study.
METHODS


We measured concentrations of procollagen type 1 pro-peptide (P1NP), carboxyl-terminal collagen crosslinks (CTX), high-sensitivity C-reactive protein (hs-CRP), D-dimer, interleukin (IL)-6, tumor necrosis factor (TNF), neopterin, and soluble CD14 and 163 at weeks 0, 12, and 48 in 123 SECOND-LINE dual-energy X-ray absorptiometry (DXA) substudy participants. Linear regression was used to compare changes in biomarkers. Predictors of ≥ 5% BMD loss were examined using multivariable regression.
RESULTS


The mean age was 38 years, the mean CD4 T-cell count was 252 cells/µL and the mean viral load was 4.2 log HIV-1 RNA copies/mL; 56% of participants were female and 47% were randomized to receive a nucleos(t)ide reverse transcriptase inhibitor [N(t)RTI]-based regimen [91% (53/58) were randomized to receive a tenofovir disoproxil fumarate (TDF)-containing regimen]. Over 48 weeks, 71% in the N(t)RTI arm experienced ≥ 5% hip BMD loss vs. 29% in the raltegravir arm (P = 0.001). Week 12 changes in P1NP and CTX were significantly greater among patients experiencing ≥ 5% hip BMD loss, patients randomized to N(t)RTI, and male patients. Predictors of ≥ 5% hip BMD loss at week 48 were P1NP increase [odds ratio (OR) 5.0; 95% confidence interval (CI) 1.1-27; P < 0.043]; N(t)RTI randomization (OR 6.7; 95% CI 2.0-27.1; P < 0.003), being African, higher baseline CD4 T cell count , and smoking.
CONCLUSIONS


In a diverse cohort of viraemic HIV-infected patients, switching to second-line antiretroviral therapy (ART) was associated with clinically significant BMD loss, which was correlated with an early increase in P1NP. Measurement of P1NP may facilitate timely interventions to reduce rapid BMD loss among at-risk patients.",2020,"Week 12 changes in P1NP and CTX were significantly greater among patients experiencing ≥ 5% hip BMD loss, patients randomized to N(t)RTI, and male patients.",['participants were female and 47'],"['tenofovir disoproxil fumarate (TDF)-containing regimen', 'nucleos(t)ide reverse transcriptase inhibitor']","['rapid BMD loss', 'mean CD4 T-cell count', 'BMD loss', 'bone mineral density loss', 'bone mineral density (BMD) loss', 'hip BMD loss', 'bone turnover and inflammatory biomarkers', 'baseline CD4 T cell count , and smoking', 'P1NP and CTX', 'concentrations of procollagen type 1 pro-peptide (P1NP), carboxyl-terminal collagen crosslinks (CTX), high-sensitivity C-reactive protein (hs-CRP), D-dimer, interleukin (IL)-6, tumor necrosis factor (TNF), neopterin, and soluble CD14', 'bone turnover, inflammation, and immune activation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0028621', 'cui_str': 'Nucleoside'}, {'cui': 'C0282519', 'cui_str': 'Reverse transcriptase inhibitor'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0068527', 'cui_str': 'Neopterin'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439662', 'cui_str': 'Immune'}]",,0.153457,"Week 12 changes in P1NP and CTX were significantly greater among patients experiencing ≥ 5% hip BMD loss, patients randomized to N(t)RTI, and male patients.","[{'ForeName': 'G E', 'Initials': 'GE', 'LastName': 'Mwasakifwa', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Amin', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'C P', 'Initials': 'CP', 'LastName': 'White', 'Affiliation': 'Department of Endocrinology, Prince of Wales Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Center', 'Affiliation': 'The Garvan Institute of Medical Research, Sydney, NSW, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kelleher', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Boyd', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, NSW, Australia.'}]",HIV medicine,['10.1111/hiv.12882']
1188,32570126,A Prospective Study Investigating Blood Patch Pleurodesis for Postoperative Air Leaks After Pulmonary Resection.,"BACKGROUND


Prolonged air leaks (PALs) after lung resection are one of the most common complications in thoracic surgery. Several options are available to treat PALs. The autologous blood patch pleurodesis is commonly used but has not been thoroughly investigated.
MATERIALS AND METHODS


We conducted a prospective randomized study including all consecutive patients with PALs after pulmonary resections. Patients were randomized to either having received pleurodesis by injecting 100 mL autologous blood at d 5 and 6 (Group A) or being placed under observation (Group B). Patients from either group undergoing revisions were further investigated by a post hoc analysis and formed Group C.
RESULTS


A total of 24 patients were included: 10 patients were randomized to group A and 14 to group B. Six patients (3 from each group) underwent surgical revision and were included in Group C. Groups A and B did not differ in baseline characteristics. The median time to drainage removal was 9 d (range: 5-23 d) in Group A; 9 d (range: 2-20 d) in Group B; and 6 d in Group C (range: 3-10 d), (A/B versus C, P < 0.04; A versus B was not significant).
CONCLUSIONS


There is no evidence indicating a benefit for blood patch pleurodeses in patients undergoing lung resections and presenting with postoperative PALs for more than 5 d. An early operative closure of postoperative air leakage seems to be more effective.",2020,"The median time to drainage removal was 9 d (range: 5-23 d) in Group A; 9 d (range: 2-20 d) in Group B; and 6 d in Group C (range: 3-10 d), (A/B versus C, P ","['all consecutive patients with PALs after pulmonary resections', 'patients undergoing lung resections and presenting with postoperative PALs for more than 5\xa0d', '24 patients were included: 10 patients']","['pleurodesis by injecting 100\xa0mL autologous blood at d 5 and 6 (Group A) or being placed under observation', 'surgical revision', 'Blood Patch Pleurodesis']","['Postoperative Air Leaks', 'blood patch pleurodeses', 'median time to drainage removal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]",24.0,0.10955,"The median time to drainage removal was 9 d (range: 5-23 d) in Group A; 9 d (range: 2-20 d) in Group B; and 6 d in Group C (range: 3-10 d), (A/B versus C, P ","[{'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Ploenes', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Ioanis', 'Initials': 'I', 'LastName': 'Kyritsis', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Mardanzai', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Muhmann', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Langehegermann', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Slama', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Hegedüs', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Aigner', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany. Electronic address: clemens.aigner@rlk.uk-essen.de.'}]",The Journal of surgical research,['10.1016/j.jss.2020.05.012']
1189,32574844,"Effect of soluble corn fiber supplementation for 1 year on bone metabolism in children, the MetA-bone trial: Rationale and design.","Calcium intake is critical for adequate bone mineralization in adolescence, but it is usually inadequate in US adolescents. A strategy to maximize bone mineralization is to increase calcium absorption, which could be achieved by soluble corn fiber (SCF). There are no studies determining the long-term effects of SCF on bone mass in children.
OBJECTIVES


To determine the effect of one-year SCF supplementation compared to placebo on bone mass and bone biomarkers in children with low habitual calcium intake. We hypothesize that SCF supplementation will result in a higher bone mineral content and higher levels of bone formation and lower bone resorption biomarkers.
METHODS


240 healthy children (10-13 years), with usual low calcium intake, will be randomized to four experimental groups for 1 year: (1) SCF (12 g/d); (2) SCF (12 g/d) + 600 mg/d of calcium; (3) Placebo (maltodextrin); and (4) Placebo +600 mg/d of calcium. The supplements have been pre-mixed with a flavored powder beverage and participants will only need to dilute it in water and drink this twice per day. Bone will be measured using dual energy x-ray absorptiometry (DXA) at baseline, 6 and 12 months. Serum bone biomarkers will be measured at baseline and at 12 months.
CONCLUSIONS


If supplementing diets with SCF lead to higher bone mass during adolescence, this could help achieve the genetic potential for PBM and to start adult life with stronger bones. If successful, SCF can be incorporated into diets for promoting bone health in adolescents.",2020,"We hypothesize that SCF supplementation will result in a higher bone mineral content and higher levels of bone formation and lower bone resorption biomarkers.
","['240 healthy children (10-13\u202fyears', 'adolescents', 'children with low habitual calcium intake', 'children']","['SCF', 'usual low calcium intake', 'soluble corn fiber supplementation', 'calcium; (3) Placebo (maltodextrin', 'Calcium intake', 'SCF supplementation', 'Placebo +600\u202fmg/d of calcium', 'placebo']","['bone metabolism', 'Serum bone biomarkers', 'bone mineral content and higher levels of bone formation and lower bone resorption biomarkers', 'bone mass and bone biomarkers']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}]","[{'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0860967', 'cui_str': 'Calcium low'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",240.0,0.314368,"We hypothesize that SCF supplementation will result in a higher bone mineral content and higher levels of bone formation and lower bone resorption biomarkers.
","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Palacios', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America. Electronic address: cristina.palacios@fiu.edu.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Trak-Fellermeier', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Pérez', 'Affiliation': 'Department of Biostatistics and Epidemiology, Graduate School of Public Health, Medical Sciences Campus, University of Puerto Rico, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Huffman', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hernandez Suarez', 'Affiliation': 'Vice Provost for Population Health and Well-being, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Bursac', 'Affiliation': 'Department of Biostatistics, Robert Stempel College of Public Health, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'T B', 'Initials': 'TB', 'LastName': 'Gambon', 'Affiliation': 'Pediatrician, Citrus Health Network, 551 W 51st Pl, Hialeah, FL 33012, United States of America.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Nakatsu', 'Affiliation': 'Department of Agronomy, College of Agriculture, Purdue University, 915 West State Street, West Lafayette, IN 47907-2053, United States of America.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Weaver', 'Affiliation': 'Distinguished Professor emerita, Purdue University, 610 Purdue Mall, West Lafayette, IN 47907, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106061']
1190,32444327,Effects of aldose reductase inhibitors on renal blood flow parameters in patients with early diabetic nephropathy.,"OBJECTIVE


To investigate the changes of renal blood flow parameters in patients with early-stage diabetic nephropathy (DN) treated with Aldose reductase inhibitors (ARI)/Epalrestat.
METHODS


In this prospective, 120 early DN patients aged 20-75 years from the Endocrinology Department of Chengyang District People's Hospital of Qingdao City in 2015 were randomized to intervention group including 68 patients and control group including 52 patients. Two groups of patients separately received Epalrestat and placebo for 3 months. Renal vascular parameters and blood biochemical index were collected at baseline and after intervention.
RESULTS


After 3 months of supplementation, Epalrestat significantly improved the renal and segmental renal arterial end-diastolic blood flow velocity (EDV) and the interlobular artery peak systolic blood flow velocity (PSV) compared with placebo. While Epalrestat markedly decreased the blood flow resistance index (RI) in interlobular artery compared to placebo. There were no significant changes in fasting blood glucose (FBG), diastolic blood pressure (DBP), systolic blood pressure (SBP), serum urinary acid (SUA), low-density lipoprotein cholesterol (LDL), triacylglycerol (TG), total cholesterol (TC), high density lipoprotein cholesterol (HDL), waist circumference (WC) and body mass index (BMI).
CONCLUSION


Epalrestat can effectively improve renal arterial blood flow and renal arterial perfusion, which play a protective role in early DN.",2020,While Epalrestat markedly decreased the blood flow resistance index (RI) in interlobular artery compared to placebo.,"[""120 early DN patients aged 20-75\u202fyears from the Endocrinology Department of Chengyang District People's Hospital of Qingdao City in 2015 were randomized to intervention group including 68 patients and control group including 52 patients"", 'patients with early diabetic nephropathy', 'patients with early-stage diabetic nephropathy (DN) treated with']","['placebo', 'Epalrestat and placebo', 'aldose reductase inhibitors', 'Aldose reductase inhibitors (ARI)/Epalrestat']","['renal arterial blood flow and renal arterial perfusion', 'renal blood flow parameters', 'fasting blood glucose (FBG), diastolic blood pressure (DBP), systolic blood pressure (SBP), serum urinary acid (SUA), low-density lipoprotein cholesterol (LDL), triacylglycerol (TG), total cholesterol (TC), high density lipoprotein cholesterol (HDL), waist circumference (WC) and body mass index (BMI', 'renal and segmental renal arterial end-diastolic blood flow velocity (EDV) and the interlobular artery peak systolic blood flow velocity (PSV', 'blood flow resistance index (RI', 'Renal vascular parameters and blood biochemical index']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0587463', 'cui_str': 'Endocrinology department'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0095278', 'cui_str': 'epalrestat'}, {'cui': 'C3653979', 'cui_str': 'Aldose reductase inhibitors'}, {'cui': 'C0002003', 'cui_str': 'Aldehyde reductase'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0229665', 'cui_str': 'Arterial blood'}, {'cui': 'C0398345', 'cui_str': 'Arterial perfusion'}, {'cui': 'C0035070', 'cui_str': 'Circulation, Renal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}]",2015.0,0.0377669,While Epalrestat markedly decreased the blood flow resistance index (RI) in interlobular artery compared to placebo.,"[{'ForeName': 'Mingxia', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': ""Laizhou People's Hospital, No.1718 Wuli Street, Laizhou City 261400, Shandong, China.""}, {'ForeName': 'Fangfang', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""Laizhou People's Hospital, No.1718 Wuli Street, Laizhou City 261400, Shandong, China.""}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Liang', 'Affiliation': ""Department of Endocrinology, Chengyang People's Hospital in Qingdao, No.600 Changcheng Road Chengyang District, Qingdao 266109, China.""}, {'ForeName': 'Xiaopang', 'Initials': 'X', 'LastName': 'Rao', 'Affiliation': ""Department of Endocrinology, Chengyang People's Hospital in Qingdao, No.600 Changcheng Road Chengyang District, Qingdao 266109, China. Electronic address: docrxp@126.com.""}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2020.107620']
1191,32446176,"Efficacy and safety of safinamide as an add-on therapy to L-DOPA for patients with Parkinson's disease: A randomized, double-blind, placebo-controlled, phase II/III study.","INTRODUCTION


Safinamide is a reversible and selective monoamine oxidase-B (MAO-B) and sodium channel inhibitor with demonstrated efficacy in mid-to late-stage Parkinson's disease (PD) as an adjunct to l-DOPA. This study aimed to confirm the efficacy and safety of safinamide in PD patients with wearing-off.
METHODS


This 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study included Japanese PD patients with wearing-off on l-DOPA treatment. Patients were randomized to receive placebo (P), safinamide 50 mg/day (S50), or safinamide 100 mg/day (S100). The primary endpoint was the change from baseline in mean daily ON-time without troublesome dyskinesias (ON-time). Other measures included the changes in mean daily OFF-time, the unified Parkinson's disease rating scale (UPDRS) score, and the PDQ-39 summary index.
RESULTS


A total of 406 subjects were randomized, of whom 349 completed the study. Baseline characteristics were balanced. Differences in the change of mean daily ON-time at Week 24 compared with the P group were 1.39 h (p = 0.0002) in the S50 group and 1.66 h (p < 0.0001) in the S100 group. Changes from baseline in mean daily OFF-time, UPDRS Part II total score (OFF phase), UPDRS Part III total score (ON phase), and UPDRS Part I also showed significant improvements. Adverse events occurred in 58.9%, 60.2%, and 61.4% of the P, S50, and S100 groups, respectively. The most common adverse drug reactions were dyskinesias (2.1%, 8.3%, and 10.6%) and visual hallucinations (1.4%, 3.0%, and 4.5%).
CONCLUSION


As an adjunct to l-DOPA, safinamide safely increased ON-time and improved PD symptoms/signs in PD patients with wearing-off.",2020,Differences in the change of mean daily ON-time at Week 24 compared with the P group were 1.39 h (p = 0.0002) in the S50 group and 1.66 h (p < 0.0001) in the S100 group.,"[""patients with Parkinson's disease"", 'PD patients with wearing-off', 'Japanese PD patients with wearing-off on l-DOPA treatment', 'A total of 406 subjects were randomized, of whom 349 completed the study']","['sodium channel inhibitor', 'safinamide', 'placebo (P), safinamide 50\xa0mg/day (S50), or safinamide 100\xa0mg/day (S100', 'placebo']","['Adverse events', 'dyskinesias', 'Efficacy and safety', 'mean daily OFF-time, UPDRS Part II total score (OFF phase), UPDRS Part III total score (ON phase), and UPDRS Part', 'visual hallucinations', 'mean daily ON-time', 'efficacy and safety', ""mean daily OFF-time, the unified Parkinson's disease rating scale (UPDRS) score, and the PDQ-39 summary index"", 'change from baseline in mean daily ON-time without troublesome dyskinesias (ON-time', 'ON-time and improved PD symptoms/signs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0872271', 'cui_str': 'Sodium channel blocker'}, {'cui': 'C1098261', 'cui_str': 'safinamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4475891', 'cui_str': 'safinamide 50 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4475900', 'cui_str': 'safinamide 100 MG'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0233763', 'cui_str': 'Visual hallucinations'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220912', 'cui_str': 'signs'}]",406.0,0.175291,Differences in the change of mean daily ON-time at Week 24 compared with the P group were 1.39 h (p = 0.0002) in the S50 group and 1.66 h (p < 0.0001) in the S100 group.,"[{'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Hattori', 'Affiliation': 'Department of Neurology, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan. Electronic address: nhattori@juntendo.ac.jp.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Tsuboi', 'Affiliation': 'Department of Neurology, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan. Electronic address: tsuboi@cis.fukuoka-u.ac.jp.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Yamamoto', 'Affiliation': 'Meiji Seika Pharma Co., Ltd., 2-4-16 Kyobashi, Chuo-ku, Tokyo, 104-8002, Japan. Electronic address: akihiko.yamamoto@meiji.com.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Sasagawa', 'Affiliation': 'Meiji Seika Pharma Co., Ltd., 2-4-16 Kyobashi, Chuo-ku, Tokyo, 104-8002, Japan. Electronic address: yuuji.sasagawa@meiji.com.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nomoto', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Graduate School of Medicine, Ehime University, Shizugawa, Tohon, Ehime, 791-0295, Japan; Saiseikai Imabari Center for Health and Welfare, 7-6-1 Kitamura, Imabari, Ehime, 799-1592, Japan. Electronic address: nomoto@m.ehime-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.04.012']
1192,31805802,Feasibility Study of a Therapeutic Mobility Summer Camp for Children with Severe Cerebral Palsy: Power Fun.,"Aim:  Powered mobility has positive effects on development of children with limited independent locomotion, but many are deprived of this opportunity due to their limitations. This study aimed to evaluate the feasibility of Power Fun, a therapeutic summer camp, for students with severe cerebral palsy (CP). Methods:  Five students with CP, ages 11-15, received personally adapted powered wheelchairs and participated daily in the camp. The camp ran five days a week during three weeks and included two mobility sessions daily. Assessments were conducted three weeks prior to the camp (T1), at baseline (T2), post-intervention (T3) and six weeks follow-up (T4). Measures used were Power Mobility Program (PMP), Assessment of Learning Power mobility use (ALP), Wheelchair Outcome Measure for Young People (WhOM-YP), Goal Attainment Scaling (GAS) and Dimensions of Mastery Questionnaire (DMQ). Results:  All participants finished the camp. Outcome measures showed no change between T1-T2 but improved significantly ( p <.05) after the intervention (T2-T3), and gains were maintained at T4 (Wilcoxon signed-rank test). Goals improved to slightly above the expected outcome (GAS average 0.11). Conclusions:  Power Fun shows good feasibility and significant improvement in mobility skills and goals of children with severe CP. Further studies are warranted.",2020,"Outcome measures showed no change between T1-T2 but improved significantly ( p <.05) after the intervention (T2-T3), and gains were maintained at T4 (Wilcoxon signed-rank test).","['children with severe CP', 'Children with Severe Cerebral Palsy', 'Five students with CP, ages 11-15, received personally adapted powered wheelchairs and participated daily in the camp', 'students with severe cerebral palsy (CP']",['Therapeutic Mobility Summer Camp'],"['Power Mobility Program (PMP), Assessment of Learning Power mobility use (ALP), Wheelchair Outcome Measure for Young People (WhOM-YP), Goal Attainment Scaling (GAS) and Dimensions of Mastery Questionnaire (DMQ', 'mobility skills and goals']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2092170', 'cui_str': 'Motorized wheelchair device'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0043143', 'cui_str': 'Wheelchair'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",5.0,0.0248582,"Outcome measures showed no change between T1-T2 but improved significantly ( p <.05) after the intervention (T2-T3), and gains were maintained at T4 (Wilcoxon signed-rank test).","[{'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Rosenberg', 'Affiliation': 'School of Occupational Therapy, Hebrew University, Jerusalem, Israel.'}, {'ForeName': 'Adina', 'Initials': 'A', 'LastName': 'Maeir', 'Affiliation': 'School of Occupational Therapy, Hebrew University, Jerusalem, Israel.'}, {'ForeName': 'Yafit', 'Initials': 'Y', 'LastName': 'Gilboa', 'Affiliation': 'School of Occupational Therapy, Hebrew University, Jerusalem, Israel.'}]",Physical & occupational therapy in pediatrics,['10.1080/01942638.2019.1695699']
1193,32569082,Are endogenous opioid mechanisms involved in the effects of aerobic exercise training on chronic low back pain?: a randomized controlled trial.,"Aerobic exercise is believed to be an effective chronic low back pain (CLBP) intervention, although its mechanisms remain largely untested. This study evaluated whether endogenous opioid (EO) mechanisms contributed to the analgesic effects of an aerobic exercise intervention for CLBP. Individuals with CLBP were randomized to a 6-week, 18-session aerobic exercise intervention (n = 38) or usual activity control (n = 44). Before and after the intervention, participants underwent separate laboratory sessions to assess responses to evoked heat pain after receiving saline placebo or intravenous naloxone (opioid antagonist) in a double-blinded, crossover fashion. Chronic pain intensity and interference were assessed before and after the intervention. Endogenous opioid analgesia was indexed by naloxone-placebo condition differences in evoked pain responses (blockade effects). Relative to controls, exercise participants reported significantly greater pre-post intervention decreases in chronic pain intensity and interference (Ps < 0.04) and larger reductions in placebo condition evoked pain responsiveness (McGill Pain Questionnaire-Short Form [MPQ]-Total). At the group level, EO analgesia (MPQ-Total blockade effects) increased significantly pre-post intervention only among female exercisers (P = 0.03). Dose-response effects were suggested by a significant positive association in the exercise group between exercise intensity (based on meeting heart rate targets) and EO increases (MPQ-Present Pain Intensity; P = 0.04). Enhanced EO analgesia (MPQ-Total) was associated with a significantly greater improvement in average chronic pain intensity (P = 0.009). Aerobic exercise training in the absence of other interventions appears effective for CLBP management. Aerobic exercise-related enhancements in endogenous pain inhibition, in part EO-related, likely contribute to these benefits.",2020,Enhanced EO analgesia (MPQ-Total) was associated with significantly greater improvement in average chronic pain intensity (p = .009).,['Individuals with CLBP'],"['aerobic exercise intervention', 'naloxone-placebo', 'aerobic exercise training', '18-session aerobic exercise intervention', 'naloxone (opioid antagonist', 'Aerobic exercise', 'endogenous opioid (EO', 'Aerobic exercise training', 'usual activity control', 'saline placebo']","['chronic pain intensity and interference', 'evoked pain responses', 'Chronic pain intensity and interference', 'EO analgesia (MPQ-Total blockade effects', 'placebo condition evoked pain responsiveness (McGill Pain Questionnaire-Short Form [MPQ]-Total', 'Enhanced EO analgesia (MPQ-Total', 'EO analgesia', 'average chronic pain intensity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0027410', 'cui_str': 'Opioid receptor antagonist'}, {'cui': 'C0205752', 'cui_str': 'Endogenous Opiates'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C0205752', 'cui_str': 'Endogenous Opiates'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",44.0,0.37122,Enhanced EO analgesia (MPQ-Total) was associated with significantly greater improvement in average chronic pain intensity (p = .009).,"[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bruehl', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, United States.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Burns', 'Affiliation': 'Department of Psychiatry, Rush University, Chicago, IL, United States.'}, {'ForeName': 'Kelli', 'Initials': 'K', 'LastName': 'Koltyn', 'Affiliation': 'Department of Kinesiology, University of Wisconsin, Madison, WI, United States.'}, {'ForeName': 'Rajnish', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, United States.'}, {'ForeName': 'Asokumar', 'Initials': 'A', 'LastName': 'Buvanendran', 'Affiliation': 'Department of Anesthesiology, Rush University, Chicago, IL, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Edwards', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, United States.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Chont', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, United States.'}, {'ForeName': 'Yung Hsuan', 'Initials': 'YH', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry, Rush University, Chicago, IL, United States.'}, {'ForeName': 'Dima', 'Initials': 'D', 'LastName': 'Quʼd', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, United States.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Stone', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, United States.'}]",Pain,['10.1097/j.pain.0000000000001969']
1194,32569757,"A prospective, multi-center randomized, controlled, blinded trial of vagus nerve stimulation for difficult to treat depression: A novel design for a novel treatment.","Few treatment options exist for patients with difficult-to-treat depression (DTD). One potentially efficacious treatment is vagus nerve stimulation (VNS): chronic stimulation of the vagus nerve using an implanted stimulator. Given a series of recent VNS clinical studies, including a large, five-year naturalistic investigation, the Center for Medicare and Medicaid Services (CMS) reconsidered the previous non coverage determination and announced coverage for patients participating in a ""coverage with evidence"" trial. This study, entitled, A PRospective, Multi-cEnter, Randomized Controlled Blinded Trial DemOnstrating the Safety and Effectiveness of VNS Therapy® System as AdjunctivE Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression (RECOVER), includes DTD patients with at least four unsuccessful antidepressant treatments in the current episode and will randomize both unipolar and bipolar DTD participants, each up to 500 evaluable enrollees. Predetermined interim analyses will define the necessary sample size. All participants will be implanted with VNS devices: half receive active stimulation during year one, and half receive delayed stimulation after year one. Participants will be followed for 5 years. This RCT is unique for DTD studies: 1) large sample size and long study duration (one year of controlled comparison); 2) use of a percent time in response as the primary outcome measure, given the chronic illness and its fluctuating course (vis-à-vis meeting a response criteria at a single time point); 3) inclusion of diverse measures of VNS impact on function, including quality of life, degree of disability, health status, and suicidality.",2020,Randomized Controlled Blinded Trial DemOnstrating the Safety and Effectiveness of VNS Therapy® System as AdjunctivE Therapy,"['depression', 'patients with difficult-to-treat depression (DTD', 'Subjects With Treatment-Resistant Depression (RECOVER), includes DTD patients with at least four unsuccessful antidepressant treatments in the current episode and will randomize both unipolar and bipolar DTD participants, each up to 500 evaluable enrollees']","['vagus nerve stimulation', 'VNS Therapy® System as AdjunctivE Therapy']","['quality of life, degree of disability, health status, and suicidality']","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0220726', 'cui_str': 'Diastrophic dysplasia'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0443340', 'cui_str': 'Unipolar'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0018759', 'cui_str': 'Health status'}]",,0.0937023,Randomized Controlled Blinded Trial DemOnstrating the Safety and Effectiveness of VNS Therapy® System as AdjunctivE Therapy,"[{'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Conway', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, 660 S. Euclid Ave, Campus Box 8134, St. Louis, MO 63110, USA. Electronic address: conwaycr@wustl.edu.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Olin', 'Affiliation': 'LivaNova PLC, London, United Kingdom. Electronic address: bryan.olin@livanova.com.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Aaronson', 'Affiliation': 'Sheppard Pratt Health System, Department of Psychiatry, University of Maryland, Baltimore, MD, USA. Electronic address: SAaronson@sheppardpratt.org.'}, {'ForeName': 'Harold A', 'Initials': 'HA', 'LastName': 'Sackeim', 'Affiliation': 'Departments of Psychiatry and Radiology, Columbia University, New York, NY, USA. Electronic address: has1@columbia.edu.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bunker', 'Affiliation': 'LivaNova PLC, Houston, TX, USA. Electronic address: Mark.Bunker@livanova.com.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Kriedt', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, 660 S. Euclid Ave, Campus Box 8134, St. Louis, MO 63110, USA. Electronic address: ckriedt@wustl.edu.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Greco', 'Affiliation': 'LivaNova PLC, SORIN Group Italia S.r.l., Milano, Italy. Electronic address: teresa.greco@livanova.com.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Broglio', 'Affiliation': 'Department of Statistics and Data Sciences, University of Texas, Austin, TX, USA.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Vestrucci', 'Affiliation': 'Berry Consultants, Austin, TX, USA; Department of Statistics and Data Sciences, University of Texas, Austin, TX, USA. Electronic address: matteo@berryconsultants.net.'}, {'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Rush', 'Affiliation': 'Duke-NUS Medical School, Singapore; Duke University, Durham, NC, USA; Texas Tech University, Permian Basin, TX, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106066']
1195,32571399,The short-term effects of sedentary behaviour on cerebral hemodynamics and cognitive performance in older adults: a cross-over design on the potential impact of mental and/or physical activity.,"BACKGROUND


Sedentary behaviour might be a potential risk factor for cognitive decline. However, the short-term effects of sedentary behaviour on (cerebro) vascular and cognitive performance in older people are unknown.
METHODS


We used a cross-over design with 22 older adults (78 years, 9 females) to assess the short-term hemodynamic and cognitive effects of three hours uninterrupted sitting and explored if these effects can be counteracted with regular (every 30 min) two-minute walking breaks. In addition, we investigated if low versus high mental activity during the three hours of sitting modified these effects. Before and after each condition, alertness, executive functioning, and working memory were assessed with the Test of Attentional Performance battery. Additionally, cerebral blood flow velocity (Transcranial Doppler) and blood pressure (Finapres) were measured in rest, and during sit-to-stand and CO 2  challenges to assess baroreflex sensitivity, cerebral autoregulation, and cerebral vasomotor reactivity.
RESULTS


No short-term differences were observed in cognitive performance, cerebral blood flow velocity, baroreflex sensitivity, cerebral autoregulation, or cerebral vasomotor reactivity across time, or between conditions. Blood pressure and cerebrovascular resistance increased over time (8.6 mmHg (5.0;12.1), p < 0.001), and 0.23 in resistance (0.01;0.45), p = 0.04). However, these effects were not mitigated by mental activity or by short walking breaks to interrupt sitting.
CONCLUSIONS


In older individuals, three hours of sitting did not influence cognitive performance or cerebral perfusion. However, the sitting period increased blood pressure and cerebrovascular resistance, which are known to negatively impact brain health in the long-term. Importantly, we found that these effects in older individuals cannot be mitigated by higher mental activity and/or regular walking breaks.
TRIAL REGISTRATION


Clinical trial registration URL: https://www.toetsingonline.nl/. Unique identifier: NL64309.091.17. Date of registration: 06-02-2018.",2020,"No short-term differences were observed in cognitive performance, cerebral blood flow velocity, baroreflex sensitivity, cerebral autoregulation, or cerebral vasomotor reactivity across time, or between conditions.","['older people', 'older adults', '22 older adults (78\u2009years, 9 females', 'older individuals']",['sedentary behaviour'],"['blood pressure and cerebrovascular resistance', 'cerebral hemodynamics and cognitive performance', 'baroreflex sensitivity, cerebral autoregulation, and cerebral vasomotor reactivity', 'alertness, executive functioning, and working memory', 'cognitive performance or cerebral perfusion', 'Blood pressure and cerebrovascular resistance', 'mental activity and/or regular walking breaks', 'Attentional Performance battery', 'cerebral blood flow velocity (Transcranial Doppler) and blood pressure (Finapres', 'cognitive performance, cerebral blood flow velocity, baroreflex sensitivity, cerebral autoregulation, or cerebral vasomotor reactivity across time, or between conditions']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0206077', 'cui_str': 'Transcranial doppler ultrasonography'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",22.0,0.07167,"No short-term differences were observed in cognitive performance, cerebral blood flow velocity, baroreflex sensitivity, cerebral autoregulation, or cerebral vasomotor reactivity across time, or between conditions.","[{'ForeName': 'Carlijn M', 'Initials': 'CM', 'LastName': 'Maasakkers', 'Affiliation': 'Department of Geriatrics/Radboud Alzheimer Center, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'René J F', 'Initials': 'RJF', 'LastName': 'Melis', 'Affiliation': 'Department of Geriatrics/Radboud Alzheimer Center, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Roy P C', 'Initials': 'RPC', 'LastName': 'Kessels', 'Affiliation': 'Department of Medical Psychology/Radboudumc Alzheimer Center, Donders Institute for Brain, Cognition and Behavior, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Gardiner', 'Affiliation': 'Centre for Health Services Research, Faculty of Medicine, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Marcel G M', 'Initials': 'MGM', 'LastName': 'Olde Rikkert', 'Affiliation': 'Department of Geriatrics/Radboud Alzheimer Center, Donders Institute for Brain, Cognition and Behavior, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Dick H J', 'Initials': 'DHJ', 'LastName': 'Thijssen', 'Affiliation': 'Department of Physiology, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Jurgen A H R', 'Initials': 'JAHR', 'LastName': 'Claassen', 'Affiliation': 'Department of Geriatrics/Radboud Alzheimer Center, Donders Institute for Brain, Cognition and Behavior, Radboud University Medical Center, Nijmegen, The Netherlands. Jurgen.Claassen@radboudumc.nl.'}]",Alzheimer's research & therapy,['10.1186/s13195-020-00644-z']
1196,32577708,"Effect of audiovisual eyeglasses on intraoperative pain, anxiety, and hemodynamic changes during mandibular third molar extraction: a randomized controlled clinical trial.","OBJECTIVES


To determine the effect of audiovisual eyeglasses in terms of anxiety relief, hemodynamic changes, and intraoperative pain in patients undergoing surgical removal of a mandibular third molar.
METHOD AND MATERIALS


A randomized controlled clinical trial with two parallel groups was carried out in patients undergoing mandibular third molar extraction. Fifteen patients watched a video with multimedia eyeglasses during the surgical procedure, whereas 15 controls had their eyes covered during extraction. The patients completed anxiety questionnaires before and after surgery. Hemodynamic changes, intraoperative pain, duration of the surgery, and overall satisfaction were recorded.
RESULTS


Thirty patients were analyzed. Intraoperative pain and the need for supplemental anesthesia were significantly more frequent in the control group (53.3% versus 13.3%; P < .05). The surgical procedure was also briefer when the eyeglasses were used (17.2 versus 28.1 minutes). Overall satisfaction was similar in both groups. No significant differences were found between the two study groups in terms of anxiety and hemodynamic parameters.
CONCLUSIONS


The use audiovisual eyeglasses should be routinely considered during mandibular third molar extraction since these devices allow reduction of intraoperative pain and surgery time. However, patient anxiety level and hemodynamic parameters seem to remain unaltered.",2020,Intraoperative pain and the need for supplemental anesthesia were significantly more frequent in the control group (53.3% versus 13.3%; P < .05).,"['patients undergoing mandibular third molar extraction', 'patients undergoing surgical removal of a mandibular third molar', 'mandibular third molar extraction', 'Thirty patients were analyzed', 'Fifteen patients watched a video with multimedia eyeglasses during the surgical procedure, whereas 15 controls had their eyes covered during extraction']",['audiovisual eyeglasses'],"['anxiety questionnaires', 'Overall satisfaction', 'anxiety relief, hemodynamic changes, and intraoperative pain', 'intraoperative pain, anxiety, and hemodynamic changes', 'Intraoperative pain and the need for supplemental anesthesia', 'anxiety and hemodynamic parameters', 'Hemodynamic changes, intraoperative pain, duration of the surgery, and overall satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0347984', 'cui_str': 'During'}]","[{'cui': 'C0015421', 'cui_str': 'Eyeglasses'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",30.0,0.0923606,Intraoperative pain and the need for supplemental anesthesia were significantly more frequent in the control group (53.3% versus 13.3%; P < .05).,"[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Luque-Ribas', 'Affiliation': ''}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Figueiredo', 'Affiliation': ''}, {'ForeName': 'Inês', 'Initials': 'I', 'LastName': 'Guerra-Pereira', 'Affiliation': ''}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Valmaseda-Castellón', 'Affiliation': ''}]","Quintessence international (Berlin, Germany : 1985)",['10.3290/j.qi.a44811']
1197,32574167,On-line anxiety level detection from biosignals: Machine learning based on a randomized controlled trial with spider-fearful individuals.,"We present performance results concerning the validation for anxiety level detection based on trained mathematical models using supervised machine learning techniques. The model training is based on biosignals acquired in a randomized controlled trial. Wearable sensors were used to collect electrocardiogram, electrodermal activity, and respiration from spider-fearful individuals. We designed and applied ten approaches for data labeling considering individual biosignals as well as subjective ratings. Performance results revealed a selection of trained models adapted for two-level (low and high) and three-level (low, medium and high) classification of anxiety using a minimal set of six features. We obtained a remarkable accuracy of 89.8% for the two-level classification and of 74.4% for the three-level classification using a short time window length of ten seconds when applying the approach that uses subjective ratings for data labeling. Bagged Trees proved to be the most suitable classifier type among the classification models studied. The trained models will have a practical impact on the feasibility study of an augmented reality exposure therapy based on a therapeutic game for the treatment of arachnophobia.",2020,We obtained a remarkable accuracy of 89.8% for the two-level classification and of 74.4% for the three-level classification using a short time window length of ten seconds when applying the approach that uses subjective ratings for data labeling.,['spider-fearful individuals'],[],[],"[{'cui': 'C0037913', 'cui_str': 'Order Araneae'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],[],,0.0208422,We obtained a remarkable accuracy of 89.8% for the two-level classification and of 74.4% for the three-level classification using a short time window length of ten seconds when applying the approach that uses subjective ratings for data labeling.,"[{'ForeName': 'Frank R', 'Initials': 'FR', 'LastName': 'Ihmig', 'Affiliation': 'Department of Biomedical Microsystems, Fraunhofer-Institut für Biomedizinische Technik IBMT, Sulzbach/Saar, Germany.'}, {'ForeName': 'Antonio Gogeascoechea', 'Initials': 'AG', 'LastName': 'H', 'Affiliation': 'Faculty of Electrical Engineering, Mathematics and Computer Science, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Neurohr-Parakenings', 'Affiliation': 'Department of Biomedical Microsystems, Fraunhofer-Institut für Biomedizinische Technik IBMT, Sulzbach/Saar, Germany.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Schäfer', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Lass-Hennemann', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Michael', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}]",PloS one,['10.1371/journal.pone.0231517']
1198,32574173,Foreskin surface area is not associated with sub-preputial microbiome composition or penile cytokines.,"OBJECTIVE


Male circumcision (MC) reduces acquisition of HIV-1 in heterosexual men by at least 60%, but the biological mechanism for this protection is incompletely understood. Previous studies have shown that a larger foreskin size, increased abundance of anaerobic bacteria in the sub-preputial space, and higher levels of pro-inflammatory cytokines on the penis are all prospectively associated with risk of HIV-1 acquisition. Since coverage of the glans on the non-erect penis is dependent on foreskin size, a larger foreskin could result in a less aerobic environment that might preferentially support anaerobic bacterial growth and induce inflammation. We therefore assessed the relationship between foreskin size, penile microbiome composition and local inflammation.
METHODS


This is a retrospective, cross-sectional analysis of 82 HIV-uninfected men who participated in a randomized trial of MC for HIV-1 prevention in Rakai, Uganda between 2003-2006. Sub-preputial swabs were collected prior to MC and assessed for cytokines (multiplexed immunosorbent assay) and bacterial load (qPCR) and taxon abundance (sequencing). Foreskin size was measured immediately after MC.
RESULTS


Foreskin surface area did not correlate with total bacterial load (rho = 0.05) nor the abundance of key taxa of bacteria previously associated with HIV-1 risk (rho = 0.04-0.25). Foreskin surface area also did not correlate with sub-preputial cytokine concentrations previously associated with HIV-1 risk (IL-8 rho = 0.05).
CONCLUSIONS


Larger foreskin size is not associated with either increased penile anaerobes or pro-inflammatory cytokines. These data suggest that foreskin size does not increase HIV-1 risk through changes in penile microbiome composition or penile inflammation.",2020,"RESULTS


Foreskin surface area did not correlate with total bacterial load (rho = 0.05) nor the abundance of key taxa of bacteria previously associated with HIV-1 risk (rho = 0.04-0.25).","['heterosexual men', '82 HIV-uninfected men who participated in a randomized trial of MC for HIV-1 prevention in Rakai, Uganda between 2003-2006']",['Male circumcision (MC'],"['Foreskin size', 'cytokines (multiplexed immunosorbent assay) and bacterial load (qPCR) and taxon abundance (sequencing', 'total bacterial load']","[{'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C0008819', 'cui_str': 'Circumcision'}]","[{'cui': 'C0227952', 'cui_str': 'Preputial structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021075', 'cui_str': 'Immunoadsorbents'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C2936404', 'cui_str': 'Bacterial Load'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.061171,"RESULTS


Foreskin surface area did not correlate with total bacterial load (rho = 0.05) nor the abundance of key taxa of bacteria previously associated with HIV-1 risk (rho = 0.04-0.25).","[{'ForeName': 'Godfrey', 'Initials': 'G', 'LastName': 'Kigozi', 'Affiliation': 'Rakai Health Sciences Program, Kalisizo, Uganda.'}, {'ForeName': 'Cindy M', 'Initials': 'CM', 'LastName': 'Liu', 'Affiliation': 'Department of Environmental and Occupational Health, Milken Institute School of Public Health, George Washington University, Washington, DC, United States of America.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Park', 'Affiliation': 'Department of Environmental and Occupational Health, Milken Institute School of Public Health, George Washington University, Washington, DC, United States of America.'}, {'ForeName': 'Zoe R', 'Initials': 'ZR', 'LastName': 'Packman', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, United States of America.'}, {'ForeName': 'Ronald H', 'Initials': 'RH', 'LastName': 'Gray', 'Affiliation': 'Rakai Health Sciences Program, Kalisizo, Uganda.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Kaul', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Aaron A R', 'Initials': 'AAR', 'LastName': 'Tobian', 'Affiliation': 'Rakai Health Sciences Program, Kalisizo, Uganda.'}, {'ForeName': 'Alison G', 'Initials': 'AG', 'LastName': 'Abraham', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States of America.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Ssekasanvu', 'Affiliation': 'Rakai Health Sciences Program, Kalisizo, Uganda.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Kagaayi', 'Affiliation': 'Rakai Health Sciences Program, Kalisizo, Uganda.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Prodger', 'Affiliation': 'Department of Microbiology and Immunology, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.'}]",PloS one,['10.1371/journal.pone.0234256']
1199,32576004,Application of an education model using the WeChat public platform in the standardized training of anesthesiology residents.,"BACKGROUND


Standardized training of clinical residents is an important way to train high-level clinicians and is an important step to ensure quality clinical work. WeChat facilitates efficient information dissemination and feedback, convenient communication. In the new media era, the influence of WeChat has inspired changes in educational methods, to explore the role of an education model using the WeChat public platform in the standardized training of anesthesiology residents.
METHODS


A total of 40 anesthesiology residents undergoing standardized training in our department from January 2016 to August 2017 were selected as subjects and randomly divided into 2 groups: traditional group (n=20) and WeChat group (n=20). In the WeChat group, in addition to the traditional clinical teaching model (lectures), the residents also received push information from the WeChat public platform for anesthesia education. The residents in the traditional group did not receive the push information and only received traditional clinical teaching. Three months later, assessment scores of and teaching quality in the 2 groups were evaluated. Teaching quality was evaluated using peer assessment and self-assessment questionnaires.
RESULTS


Residents in the WeChat group performed significantly better on assessments than those in traditional group regarding theoretical knowledge of anesthesiology, understanding mechanisms, operation ability, current knowledge, case analyses and use of professional English (P<0.05). The questionnaire results indicated that the degree of satisfaction of the residents and teachers in the WeChat group was significantly higher than that in the traditional group (P<0.05). The theoretical knowledge scores, operational skill scores and overall scores in the WeChat group were significantly higher than those in the traditional group (P<0.05).
CONCLUSIONS


Applying an education model based on the WeChat public platform in standardized training of anesthesiology residents can significantly improve teaching efficacy and satisfaction, enhance comprehensive assessment results, and improve teaching quality.",2020,"RESULTS


Residents in the WeChat group performed significantly better on assessments than those in traditional group regarding theoretical knowledge of anesthesiology, understanding mechanisms, operation ability, current knowledge, case analyses and use of professional English (P<0.05).","['40 anesthesiology residents undergoing standardized training in our department from January 2016 to August 2017', 'anesthesiology residents']","['push information and only received traditional clinical teaching', 'WeChat']","['teaching quality', 'theoretical knowledge scores, operational skill scores and overall scores', 'Teaching quality', 'teaching efficacy and satisfaction', 'assessment scores of and teaching quality', 'theoretical knowledge of anesthesiology, understanding mechanisms, operation ability, current knowledge, case analyses and use of professional English']","[{'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0039401', 'cui_str': 'Education'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0376245', 'cui_str': 'English language'}]",,0.0113754,"RESULTS


Residents in the WeChat group performed significantly better on assessments than those in traditional group regarding theoretical knowledge of anesthesiology, understanding mechanisms, operation ability, current knowledge, case analyses and use of professional English (P<0.05).","[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Guanghui', 'Initials': 'G', 'LastName': 'An', 'Affiliation': 'Department of Anesthesiology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'You', 'Affiliation': 'Department of Anesthesiology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Shiwei', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jinbao', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. lijinbaoshanghai@163.com.'}]",Annals of palliative medicine,['10.21037/apm-19-390']
1200,32579549,"A novel nutritional supplement containing amino acids and chromium decreases postprandial glucose response in a randomized, double-blind, placebo-controlled study.","High postprandial blood glucose levels are associated with increased mortality, cardiovascular events and development of diabetes in the general population. Interventions targeting postprandial glucose have been shown to prevent both cardiovascular events and diabetes. This study evaluates the efficacy and safety of a novel nutritional supplement targeting postprandial glucose excursions in non-diabetic adults. Sixty overweight healthy male and female participants were recruited at two centers and randomized in a double-blind, placebo-controlled, crossover design. The supplement, a water-based drink containing 2.6g of amino acids (L-Leucine, L-Threonine, L-Lysine Monohydrochloride, L-Isoleucine, L-Valine) and 250 mcg of chromium picolinate, was consumed with a standardized carbohydrate-rich meal. The primary endpoint was the incremental area under the curve (iAUC) for venous blood glucose from 0 to 120 minutes. Secondary endpoints included glucose iAUC 0-180 minutes and the maximum glucose concentration (Cmax), for both venous and capillary blood glucose. In the intention-to-treat-analysis (n = 60) the supplement resulted in a decreased venous blood glucose iAUC0-120min compared to placebo, mean (SE) of 68.7 (6.6) versus 52.2 (6.8) respectively, a difference of -16.5 mmol/L•min (95% CI -3.1 to -30.0, p = 0.017). The Cmax for venous blood glucose for the supplement and placebo were 6.45 (0.12) versus 6.10 (<0.12), respectively, a difference of -0.35 mmol/L (95% CI -0.17 to -0.53, p<0.001). In the per protocol-analysis (n = 48), the supplement resulted in a decreased Cmax compared to placebo from 6.42 (0.14) to 6.12 (0.14), a difference of -0.29 mmol/L (95% CI -0.12 to -0.47, p = 0.002). No significant differences in capillary blood glucose were found, as measured by regular bed-side glucometers. The nutritional supplement drink containing amino acids and chromium improves the postprandial glucose homeostasis in overweight adults without diabetes. Future studies should clarify, whether regular consumption of the supplement improves markers of disease or could play a role in a diet aiming at preventing the development of diabetes.",2020,"In the intention-to-treat-analysis (n = 60) the supplement resulted in a decreased venous blood glucose iAUC0-120min compared to placebo, mean (SE) of 68.7 (6.6) versus 52.2 (6.8) respectively, a difference of -16.5 mmol/L•min (95% CI -3.1 to -30.0, p = 0.017).","['Sixty overweight healthy male and female participants', 'non-diabetic adults', 'overweight adults without diabetes']","['novel nutritional supplement targeting postprandial glucose excursions', 'nutritional supplement drink containing amino acids and chromium', 'water-based drink containing 2.6g of amino acids (L-Leucine, L-Threonine, L-Lysine Monohydrochloride, L-Isoleucine, L-Valine) and 250 mcg of chromium picolinate, was consumed with a standardized carbohydrate-rich meal', 'amino acids and chromium', 'placebo']","['glucose iAUC 0-180 minutes and the maximum glucose concentration (Cmax), for both venous and capillary blood glucose', 'High postprandial blood glucose levels', 'capillary blood glucose', 'incremental area under the curve (iAUC) for venous blood glucose', 'Cmax for venous blood glucose', 'efficacy and safety', 'postprandial glucose homeostasis', 'postprandial glucose response', 'mortality, cardiovascular events and development of diabetes', 'venous blood glucose iAUC0-120min']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0040005', 'cui_str': 'Threonine'}, {'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C0022192', 'cui_str': 'Isoleucine'}, {'cui': 'C0042285', 'cui_str': 'Valine'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0163657', 'cui_str': 'CHROMIUM PICOLINATE'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",60.0,0.255059,"In the intention-to-treat-analysis (n = 60) the supplement resulted in a decreased venous blood glucose iAUC0-120min compared to placebo, mean (SE) of 68.7 (6.6) versus 52.2 (6.8) respectively, a difference of -16.5 mmol/L•min (95% CI -3.1 to -30.0, p = 0.017).","[{'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Östman', 'Affiliation': 'Food for Health Science Center, Lund University, Lund, Sweden.'}, {'ForeName': 'Azat', 'Initials': 'A', 'LastName': 'Samigullin', 'Affiliation': 'StarScience GmbH, Heidelberg, Germany.'}, {'ForeName': 'Lovisa', 'Initials': 'L', 'LastName': 'Heyman-Lindén', 'Affiliation': 'Aventure AB, Lund, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Andersson', 'Affiliation': 'Aventure AB, Lund, Sweden.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Björck', 'Affiliation': 'Food for Health Science Center, Lund University, Lund, Sweden.'}, {'ForeName': 'Rickard', 'Initials': 'R', 'LastName': 'Öste', 'Affiliation': 'Food for Health Science Center, Lund University, Lund, Sweden.'}, {'ForeName': 'Per M', 'Initials': 'PM', 'LastName': 'Humpert', 'Affiliation': 'StarScience GmbH, Heidelberg, Germany.'}]",PloS one,['10.1371/journal.pone.0234237']
1201,32449505,The Effects of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients with Digestive System or Lung Cancer: Protocol for a Randomized Controlled Trial.,"BACKGROUND


The side effects of chemotherapy, specifically chemotherapy-induced nausea and vomiting, are a concern for patients. To relieve these side effects, antiemetic drugs are recommended. However, some patients report that these drugs are not sufficiently effective. Moreover, patients with chronic disease, including cancer, are increasingly interested in complementary and alternative medicines, and express the desire for nonpharmacological treatments to be used in hospitals. Foot reflexology is a holistic approach that is reported to significantly reduce the severity of chemotherapy-induced nausea and vomiting in patients with breast cancer. Some of the chemotherapy treatments for patients with lung and digestive system cancer are moderately or highly emetic.
OBJECTIVE


The primary objective of this study is to assess the benefits of foot reflexology, together with conventional treatments, on the severity and frequency of chemotherapy-induced nausea and vomiting in patients with lung or digestive system cancer. The secondary objectives to be assessed are quality of life, anxiety, and self-esteem.
METHODS


This study is an open-label randomized controlled trial conducted over 22 months (18 months intervention and 4 months follow-up). Eligible participants are patients with a lung or digestive system cancer with an indication for platinum-based chemotherapy. Participants are randomized into two groups: conventional care with foot reflexology and conventional care without foot reflexology. Foot reflexology sessions (30 minutes) are performed on an outpatient or inpatient basis. It was estimated that 40 participants per group will be required. The benefits of foot reflexology will be assessed by comparing the relative change in the severity of nausea and vomiting, as assessed by a visual analogue scale, and the frequency of these side effects between the two groups. The secondary objectives will be assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; Hospital and Anxiety Depression Scale; and Body Image Questionnaire.
RESULTS


This study was approved by the regional ethics committee (Île de France X CPP) on April 3, 2018 (No. ID RCB 2018-A00571-54). Enrollment started in June 2018. Data analysis will be performed during the second quarter of 2020 and results will be published in the last quarter of 2020.
CONCLUSIONS


The lack of knowledge regarding the efficacy and safety of foot reflexology limits oncologists to recommend it for this use. This study will provide evidence of the benefits of foot reflexology. If efficacy is confirmed, foot reflexology may be a promising complement to conventional antiemetic drugs.
TRIAL REGISTRATION


Clinicaltrials.gov NCT03508180; https://www.clinicaltrials.gov/ct2/show/NCT03508180.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17232.",2020,Foot reflexology is a holistic approach that is reported to decrease significant reduction in the severity of chemotherapy-induced nausea and vomiting in breast cancer patients.,"['patients with chronic disease, including cancer', 'Eligible participants are patients with a lung or digestive cancer with indication for platinum-based chemotherapy', 'lung and digestive cancer patients', 'breast cancer patients', 'digestive or lung cancer patients']","['chemotherapy', 'Foot reflexology sessions', 'foot reflexology', 'conventional care with foot reflexology and conventional care without foot reflexology']","['Cancer Quality of Life Questionnaire - Core 30 items, Hospital and Anxiety Depression Scale and Body Image Questionnaire', 'quality of life, anxiety, and self-esteem', 'nausea and vomiting', 'severity and frequency of chemotherapy-induced nausea and vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0012238', 'cui_str': 'Digestive system function'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0451107', 'cui_str': 'Depression anxiety scale'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0401160', 'cui_str': 'Chemotherapy-induced nausea and vomiting'}]",70.0,0.0859635,Foot reflexology is a holistic approach that is reported to decrease significant reduction in the severity of chemotherapy-induced nausea and vomiting in breast cancer patients.,"[{'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Murat-Ringot', 'Affiliation': 'Centre de Coordination en Cancérologie, Hospices Civils de Lyon, Pierre-Benite, France.'}, {'ForeName': 'Pierre Jean', 'Initials': 'PJ', 'LastName': 'Souquet', 'Affiliation': 'Centre de Coordination en Cancérologie, Hospices Civils de Lyon, Pierre-Benite, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Chauvenet', 'Affiliation': 'Centre de Coordination en Cancérologie, Hospices Civils de Lyon, Pierre-Benite, France.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Rentler', 'Affiliation': 'Centre de Coordination en Cancérologie, Hospices Civils de Lyon, Pierre-Benite, France.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Subtil', 'Affiliation': 'Centre de Coordination en Cancérologie, Hospices Civils de Lyon, Pierre-Benite, France.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Schott', 'Affiliation': 'HESPER EA7425, Université Lyon 1, Lyon, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Preau', 'Affiliation': 'Laboratoire GREPS EA 4163, Institut de Psychologie, Université Lyon 2, Bron, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Piriou', 'Affiliation': 'HESPER EA7425, Université Lyon 1, Lyon, France.'}]",JMIR research protocols,['10.2196/17232']
1202,32449542,Should We Consider Deep Brain Stimulation Discontinuation in Late-Stage Parkinson's Disease?,"BACKGROUND


Subthalamic deep brain stimulation (STN-DBS) effects may decrease with Parkinson's disease (PD) progression. There is no indication if, when, and how to consider the interruption of DBS treatment in late-stage PD. The objective of the current study was to investigate the percentage of ""poor stimulation responders"" among late-stage PD patients for elaborating an algorithm to decide whether and when DBS discontinuation may be considered.
METHODS


Late-stage PD patients (Hoehn Yahr stage ≥4 and Schwab and England Scale <50 in medication on/stimulation on condition) treated with STN-DBS for at least 5 years underwent a crossover, double-blind, randomized evaluation of acute effects of stimulation. Physicians, caregivers, and patients were blinded to stimulation conditions. Poor stimulation responders (MDS-UPDRS part III change <10% between stimulation on/medication off and stimulation off/medication off) maintained the stimulation off/medication on condition for 1 month for open-label assessment.
RESULTS


Thirty-six patients were included. The acute effect of stimulation was significant (17% MDS-UPDRS part III), with 80% of patients classified as ""good responders."" Seven patients were classified as ""poor stimulation responders,"" and the stimulation was switched off, but in 4 cases the stimulation was switched back ""on"" because of worsening of parkinsonism and dysphagia with a variable time delay (up to 10 days). No serious adverse effects occurred.
CONCLUSIONS


The vast majority of late-stage PD patients (92%) show a meaningful response to STN-DBS. Effects of stimulation may take days to disappear after its discontinuation. We present a safe and effective decisional algorithm that could guide physicians and caregivers in making challenging therapeutic decisions in late-stage PD. © 2020 International Parkinson and Movement Disorder Society.",2020,"No serious adverse effects occurred.
","['Thirty-six patients were included', 'Late-stage PD patients (Hoehn Yahr stage ≥4 and Schwab and England Scale <50 in medication on/stimulation on condition) treated with STN-DBS for at least 5\u2009years']","['Deep Brain Stimulation Discontinuation', 'Subthalamic deep brain stimulation (STN-DBS']",[],"[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0038427', 'cui_str': 'Bruneomycin'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0038427', 'cui_str': 'Bruneomycin'}]",[],36.0,0.041704,"No serious adverse effects occurred.
","[{'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Fabbri', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini,"", University of Torino, Turin, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Zibetti', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini,"", University of Torino, Turin, Italy.'}, {'ForeName': 'Mario Giorgio', 'Initials': 'MG', 'LastName': 'Rizzone', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini,"", University of Torino, Turin, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Giannini', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Borellini', 'Affiliation': ""U.O. Neurofisiopatologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Stefani', 'Affiliation': 'Department of System Medicine, UOSD Parkinson, University of Rome ""Tor Vergata,"", Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bove', 'Affiliation': 'U.O.C. Neurologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bruno', 'Affiliation': 'IRCCS Neuromed, Pozzilli, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Calandra-Buonaura', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Modugno', 'Affiliation': 'IRCCS Neuromed, Pozzilli, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Piano', 'Affiliation': 'U.O.C. Neurologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Peppe', 'Affiliation': 'IRCCS Santa Lucia Foundation, Rome, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Ardolino', 'Affiliation': ""U.O. Neurofisiopatologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Romagnolo', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini,"", University of Torino, Turin, Italy.'}, {'ForeName': 'Carlo Alberto', 'Initials': 'CA', 'LastName': 'Artusi', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini,"", University of Torino, Turin, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Berchialla', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Torino, Torino, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Montanaro', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini,"", University of Torino, Turin, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Cortelli', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.'}, {'ForeName': 'Romito', 'Initials': 'R', 'LastName': 'Luigi', 'Affiliation': 'Department of Clinical Neurosciences, Movement Disorders Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Eleopra', 'Affiliation': 'Department of Clinical Neurosciences, Movement Disorders Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Brigida', 'Initials': 'B', 'LastName': 'Minafra', 'Affiliation': 'Parkinson and Movement Disorder Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Pacchetti', 'Affiliation': 'Parkinson and Movement Disorder Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Tufo', 'Affiliation': 'U.O.C. Neurochirurgia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Cogiamanian', 'Affiliation': ""U.O. Neurofisiopatologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.""}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Lopiano', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini,"", University of Torino, Turin, Italy.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28091']
1203,32448020,Glutamatergic and GABAergic reactivity and cognition in 22q11.2 deletion syndrome and healthy volunteers: A randomized double-blind 7-Tesla pharmacological MRS study.,"AIMS


22q11.2 deletion syndrome (22q11.2DS) is associated with impaired cognitive functioning. Glutamatergic pathways have been linked with cognition and are hypothesized to be disrupted in 22q11.2DS patients, possibly 'shifting' the excitatory (glutamate)/inhibitory (GABA) balance. Hence, the glutamate/GABA balance may constitute a target for pharmacological treatment. We aimed to examine alterations of glutamate/GABA metabolites in 22q11.2DS  in vivo  using riluzole, a compound with glutamate/GABA-modulating action, as pharmacological challenge.
METHODS


Seventeen 22q11.2DS patients and 20 matched healthy controls were enrolled in this randomized double-blind placebo-controlled crossover study. Glutamate and glutamine concentrations in the anterior cingulate cortex (ACC) and striatum, as well as ACC GABA concentrations were obtained after placebo and after a single dose of 50 mg riluzole using 7-Tesla magnetic resonance spectroscopy (MRS). Within the 22q11.2DS group, the relationship between metabolite concentrations and cognition was examined.
RESULTS


No group differences were found in ACC and striatal metabolite concentrations following placebo. Riluzole numerically decreased ACC ( η 2   = 0.094 ) but not striatal glutamate concentrations as well as ACC GABA concentrations ( η 2   = 0.176 ) in all subjects. In both regions, riluzole did not alter glutamine concentration. No interaction effects were found. Although not significant after Bonferroni correction, ACC glutamate concentrations were inversely correlated with cognitive functions in 22q11.2DS patients.
DISCUSSION


We did not demonstrate altered ACC and striatal metabolite concentrations in 22q11.2DS. Nevertheless, these results suggest that glutamate and GABA can be modulated with a single dose of riluzole. Possibly, riluzole may have memory-enhancing effects in 22q11.2DS. Future studies should examine the long-term effects of riluzole on cognition.",2020,Riluzole numerically decreased ACC ( η 2   = 0.094 ) but not striatal glutamate concentrations as well as ACC GABA concentrations ( η 2   = 0.176 ) in all subjects.,"['Seventeen 22q11.2DS patients and 20 matched healthy controls', '22q11.2 deletion syndrome and healthy volunteers', '22q11.2DS patients']","['Riluzole', 'riluzole', 'placebo']","['ACC GABA concentrations', 'ACC glutamate concentrations', 'ACC and striatal metabolite concentrations', 'cognitive functions', 'ACC', 'glutamine concentration']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0220704', 'cui_str': 'Velo-cardio-facial syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012236', 'cui_str': ""DiGeorge's syndrome""}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0073379', 'cui_str': 'Riluzole'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}]",,0.0789898,Riluzole numerically decreased ACC ( η 2   = 0.094 ) but not striatal glutamate concentrations as well as ACC GABA concentrations ( η 2   = 0.176 ) in all subjects.,"[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Vingerhoets', 'Affiliation': 'Department of Psychiatry & Neuropsychology, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Desmond Hy', 'Initials': 'DH', 'LastName': 'Tse', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'van Oudenaren', 'Affiliation': 'Department of Psychiatry & Neuropsychology, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Hernaus', 'Affiliation': 'Department of Psychiatry & Neuropsychology, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'van Duin', 'Affiliation': 'Department of Psychiatry & Neuropsychology, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Janneke', 'Initials': 'J', 'LastName': 'Zinkstok', 'Affiliation': 'Department of Psychiatry & UMC Utrecht Brain Center, University Medical Center, Utrecht, the Netherlands.'}, {'ForeName': 'Johannes G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Jacobus Fa', 'Initials': 'JF', 'LastName': 'Jansen', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Grainne', 'Initials': 'G', 'LastName': 'McAlonan', 'Affiliation': ""The Sackler Institute for Translational Neurodevelopment, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'van Amelsvoort', 'Affiliation': 'Department of Psychiatry & Neuropsychology, Maastricht University, Maastricht, the Netherlands.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120922977']
1204,32452969,"Performance of Male Condoms When Used With and Without a Silicone Placebo Vaginal Ring-A Randomized, Crossover Trial.","BACKGROUND


The dapivirine vaginal ring reduced the risk of HIV infection by approximately 30% in Phase III trials. To ensure higher levels of protection against HIV and sexually transmitted infections, women should be counseled to use condoms when using the vaginal ring. This article evaluates the compatibility of male condoms with a placebo vaginal ring.
METHODS


This was a 2-period crossover, randomized, noninferiority trial. Couples in 2 sites in the United States were randomized to male condom use, with and without a placebo silicone vaginal ring, and asked to use 4 male condoms in each period. The primary noninferiority end points were total clinical failure and their component failure events (clinical breakage or slippage). Frequencies and percentages were calculated for each failure mode and differences in performance of the 2 periods using the male condom without the ring as reference. Noninferiority was defined using a 3% margin at the 5% significance level. Safety and acceptability were also assessed.
RESULTS


Seventy couples were enrolled, and 68 completed the trial with a total of 275 male condoms used in each period. Total condom clinical failure rates were 2.2% and 4.0% in the presence and absence of the vaginal ring, respectively, with a difference of -1.9% (95% confidence interval: -5.3% to 1.5%), thereby demonstrating noninferiority when used with the ring. There was no difference in safety between the 2 periods.
DISCUSSION


Concurrent use of the placebo silicone vaginal ring had no significant effect on male condom functionality or safety outcomes.",2020,"There was no difference in safety between the two periods.
","['Couples in two sites in the United States of America', 'Seventy couples were enrolled, and 68 completed the trial with a total of 275 male condoms used in each period', 'male condoms with a placebo vaginal ring']","['Silicone Placebo', 'placebo silicone vaginal ring']","['risk of HIV infection', 'Total condom clinical failure rates', 'safety', 'total clinical failure and their component failure events (clinical breakage or slippage', 'male condom functionality or safety outcomes', 'Safety and acceptability']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}]","[{'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",275.0,0.452772,"There was no difference in safety between the two periods.
","[{'ForeName': 'Annalene', 'Initials': 'A', 'LastName': 'Nel', 'Affiliation': 'International Partnership for Microbicides, Silver Spring, MD.'}, {'ForeName': 'Mariëtte', 'Initials': 'M', 'LastName': 'Malherbe', 'Affiliation': 'International Partnership for Microbicides, Silver Spring, MD.'}, {'ForeName': 'Neliëtte', 'Initials': 'N', 'LastName': 'van Niekerk', 'Affiliation': 'International Partnership for Microbicides, Silver Spring, MD.'}, {'ForeName': 'Mags', 'Initials': 'M', 'LastName': 'Beksinska', 'Affiliation': 'MRU [Maternal, Adolescent and Child Health Research Unit], Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Greener', 'Affiliation': 'MRU [Maternal, Adolescent and Child Health Research Unit], Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Smit', 'Affiliation': 'MRU [Maternal, Adolescent and Child Health Research Unit], Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Frezieres', 'Affiliation': 'Essential Access Health, Los Angeles, CA.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Walsh', 'Affiliation': 'Essential Access Health, Los Angeles, CA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002397']
1205,32452973,"Performance and Acceptability of the FC2 Female Condom When Used With and Without a Silicone Placebo Vaginal Ring-A Randomized, Crossover Trial.","BACKGROUND


The silicone Dapivirine Vaginal Ring 25 mg, has been developed to provide an additional HIV prevention option for women. If approved for use, women will always be counselled to use condoms when using the vaginal ring for maximum protection. This paper evaluates the compatibility of female condoms with the ring.
METHODS


This was a 2-period crossover, randomized noninferiority trial. Couples in 2 sites in the United States of America were randomized to FC2 Female Condom (FC2) with and without a placebo silicone ring and asked to use 4 female condoms in each period. The primary noninferiority endpoint was the clinical failure rate during intercourse or withdrawal (self-reported clinical breakage, slippage, misdirection, and invagination). Frequencies and percentages were calculated for each failure mode and differences in performance of the 2 periods, using the female condom without the ring as reference. Noninferiority was defined using an 8% margin at the 5% significance level. Safety and tolerability were also assessed.
RESULTS


Eighty-one couples were enrolled and 79 completed the trial using a total of 596 female condoms (297 and 299 with/without a ring inserted, respectively). Total female condom clinical failure was 14.1% and 15.7% in the presence and absence of a ring, respectively, with a difference of -2.1% (95% confidence interval: -7.8% to 3.6%), thereby demonstrating noninferiority when used with the ring. There were no differences in safety and tolerability between the 2 periods.
DISCUSSION


Concurrent use of the placebo silicone vaginal ring had no significant effect on female condom functionality or safety outcomes.",2020,"There were no differences in safety and tolerability between the two periods.
","['female condoms with the ring', 'Eighty-one couples were enrolled and 79 completed the trial using a total of 596 female condoms (297 and 299 with/without a ring inserted, respectively', 'Couples in two sites in the United States of America', 'women']","['FC2 Female Condom®', 'FC2 Female Condom (FC2) with and without a placebo silicone', 'placebo silicone vaginal ring']","['Total female condom clinical failure', 'Safety and tolerability', 'safety and tolerability', 'female condom functionality or safety outcomes', 'clinical failure rate during intercourse or withdrawal (self-reported clinical breakage, slippage, misdirection and invagination', 'Performance and Acceptability']","[{'cui': 'C0221829', 'cui_str': 'Female condom'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0221829', 'cui_str': 'Female condom'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0221829', 'cui_str': 'Female condom'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0221224', 'cui_str': 'Invagination'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",81.0,0.391157,"There were no differences in safety and tolerability between the two periods.
","[{'ForeName': 'Annalene', 'Initials': 'A', 'LastName': 'Nel', 'Affiliation': 'International Partnership for Microbicides, Silver Spring, MD.'}, {'ForeName': 'Mariëtte', 'Initials': 'M', 'LastName': 'Malherbe', 'Affiliation': 'International Partnership for Microbicides, Silver Spring, MD.'}, {'ForeName': 'Neliëtte', 'Initials': 'N', 'LastName': 'van Niekerk', 'Affiliation': 'International Partnership for Microbicides, Silver Spring, MD.'}, {'ForeName': 'Mags', 'Initials': 'M', 'LastName': 'Beksinska', 'Affiliation': 'MRU [Maternal, Adolescent and Child Health Research Unit], Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Greener', 'Affiliation': 'MRU [Maternal, Adolescent and Child Health Research Unit], Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Smit', 'Affiliation': 'MRU [Maternal, Adolescent and Child Health Research Unit], Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Frezieres', 'Affiliation': 'Essential Access Health, Los Angeles, CA.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Walsh', 'Affiliation': 'Essential Access Health, Los Angeles, CA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002408']
1206,32450497,Effect of brexpiprazole on control of impulsivity in schizophrenia: A randomized functional magnetic resonance imaging study.,"Impulsivity in schizophrenia is a risk factor for suicide, drug abuse, and other risk-taking behaviors. This exploratory, multicenter, randomized, double-blind, functional magnetic resonance imaging (fMRI) study assessed the effects of brexpiprazole on brain regions that control impulsive behavior. Thirty-eight outpatients with stable schizophrenia and impulsivity symptoms were randomized to 6 weeks of brexpiprazole 2 or 4 mg/day. The prespecified outcome measure was blood oxygen-level dependent (BOLD) activation in the right ventrolateral prefrontal cortex (VLPFC) during performance of tasks associated with inhibition/control of impulsivity: the go/no-go task and stop-signal task. Secondary objectives evaluated the efficacy, safety and tolerability of brexpiprazole. Over 6 weeks, patients receiving brexpiprazole had no statistically significant change in right VLPFC BOLD activation during the go/no-go task, but showed a significant decrease in right VLPFC BOLD activation during the stop-signal task. Brexpiprazole was also associated with significantly improved stop-signal reaction time (SSRT). No worsening of psychiatric symptoms, functioning, or impulsivity occurred in these patients. No unexpected safety or tolerability concerns were identified. In conclusion, brexpiprazole treatment among patients with schizophrenia and impulsivity was associated with decreased right VLPFC activation and decreased SSRT, supportive of a benefit of brexpiprazole on inhibition-related brain activation and behavior. ClinicalTrials.gov identifier: NCT02194933.",2020,"Over 6 weeks, patients receiving brexpiprazole had no statistically significant change in right VLPFC BOLD activation during the go/no-go task, but showed a significant decrease in right VLPFC BOLD activation during the stop-signal task.","['Thirty-eight outpatients with stable schizophrenia and impulsivity symptoms', 'schizophrenia', 'patients with schizophrenia and impulsivity']","['brexpiprazole', 'functional magnetic resonance imaging (fMRI', 'Brexpiprazole']","['blood oxygen-level dependent (BOLD) activation in the right ventrolateral prefrontal cortex (VLPFC) during performance of tasks associated with inhibition/control of impulsivity: the go/no-go task and stop-signal task', 'right VLPFC BOLD activation', 'safety or tolerability concerns', 'right VLPFC activation', 'psychiatric symptoms, functioning, or impulsivity', 'efficacy, safety and tolerability of brexpiprazole', 'stop-signal reaction time (SSRT']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3885614', 'cui_str': 'brexpiprazole'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C3266730', 'cui_str': 'Ventrolateral'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3885614', 'cui_str': 'brexpiprazole'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",38.0,0.07473,"Over 6 weeks, patients receiving brexpiprazole had no statistically significant change in right VLPFC BOLD activation during the go/no-go task, but showed a significant decrease in right VLPFC BOLD activation during the stop-signal task.","[{'ForeName': 'Theo Gm', 'Initials': 'TG', 'LastName': 'van Erp', 'Affiliation': 'Clinical and Translational Neuroscience Laboratory, University of California-Irvine, Irvine, CA, United States; Center for the Neurobiology of Learning and Memory, University of California-Irvine, Irvine, CA, United States. Electronic address: tvanerp@uci.edu.'}, {'ForeName': 'Ross A', 'Initials': 'RA', 'LastName': 'Baker', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, United States.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Cox', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, United States.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Okame', 'Affiliation': 'Otsuka Pharmaceutical Co. Ltd., Kanda Tsukasa-machi, Chiyoda-ku, Tokyo101-8535, Japan.'}, {'ForeName': 'Yoshitsugu', 'Initials': 'Y', 'LastName': 'Kojima', 'Affiliation': 'Otsuka Pharmaceutical Co. Ltd., Kanda Tsukasa-machi, Chiyoda-ku, Tokyo101-8535, Japan.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Eramo', 'Affiliation': 'Lundbeck LLC, Deerfield, IL, United States.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Potkin', 'Affiliation': 'University of California-Irvine, Irvine, CA, United States; Tibor Rubin Veterans Affairs Medical Center, Long Beach, CA, United States. Electronic address: sgpotkin@gmail.com.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2020.111085']
1207,32479544,Long-term effects of a three-component lifestyle intervention on emotional well-being in women with Polycystic Ovary Syndrome (PCOS): A secondary analysis of a randomized controlled trial.,"Many women with Polycystic Ovary Syndrome (PCOS) report high depression rates. The relationship between PCOS and these high depression rates is unclear. Two-component lifestyle interventions have revealed short-term effects on depression scores in this group of women. In general, 3-component interventions including diet, exercise, and cognitive behavioral therapy (CBT) are more effective in the long-term to improve emotional well-being. This has not yet been studied in women with PCOS. This study examined the effect of 20 CBT lifestyle (LS) sessions combined with a healthy diet and physical therapy with or without 9 months additional feedback through Short Message Service (SMS) via mobile phone, compared to care as usual (CAU, involving advice to lose weight). In this secondary analysis, 155 women with PCOS and a BMI above 25 kg/m2 were eligible. Depression scores decreased significantly in the LS programme compared to CAU (P = 0.045). In both the LS programme without SMS (P = 0.036) and the LS programme with SMS (P = 0.011) depression scores decreased while no change was observed in CAU (P = 0.875). Self-esteem scores improved significantly in the LS programme compared to CAU (P = 0.027). No differences in body image scores were observed in LS participants compared to CAU (P = 0.087), although body image improved significantly in both the LS without SMS (P = 0.001) and with SMS (P = 0.008) study arms. We found no significant mediating role by androgens in the relationship between LS participants and emotional well-being. Only weight-loss mediated the relationship between LS and self-esteem. To conclude, a three-component lifestyle intervention programme with or without additional SMS resulted in significant improvements in depression and self-esteem compared to CAU, in women with PCOS, obesity, and a wish to achieve a pregnancy. Testosterone, androstenedione, DHEA, insulin, HOMA-IR, and cortisol did not mediate this effect. Weight loss mediated the effects on self-esteem but not on depression and body-image. This suggests that lifestyle treatment independent of weight loss can reduce depression and body-image, but both lifestyle treatment and weight loss can improve self-esteem. Thus, a three-component lifestyle intervention based on CBT could prove successful in improving mood in women with PCOS who are overweight or obese and attempting to become pregnant.",2020,Self-esteem scores improved significantly in the LS programme compared to CAU (P = 0.027).,"['155 women with PCOS and a BMI above 25 kg/m2 were eligible', 'women with Polycystic Ovary Syndrome (PCOS', 'women with PCOS', 'women with PCOS who are overweight or obese and attempting to become pregnant']","['three-component lifestyle intervention', 'CBT', '3-component interventions including diet, exercise, and cognitive behavioral therapy (CBT', '20 CBT lifestyle (LS) sessions combined with a healthy diet and physical therapy with or without 9 months additional feedback through Short Message Service (SMS) via mobile phone, compared to care as usual (CAU, involving advice to lose weight']","['Depression scores', 'depression and self-esteem', 'Testosterone, androstenedione, DHEA, insulin, HOMA-IR, and cortisol', 'depression scores', 'body image scores', 'self-esteem', 'Self-esteem scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}]","[{'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0444892', 'cui_str': 'CAU'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0002860', 'cui_str': 'Androstenedione'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]",155.0,0.0638994,Self-esteem scores improved significantly in the LS programme compared to CAU (P = 0.027).,"[{'ForeName': 'Geranne', 'Initials': 'G', 'LastName': 'Jiskoot', 'Affiliation': 'Division Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Dietz de Loos', 'Affiliation': 'Division Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Annemerle', 'Initials': 'A', 'LastName': 'Beerthuizen', 'Affiliation': 'Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Reinier', 'Initials': 'R', 'LastName': 'Timman', 'Affiliation': 'Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Busschbach', 'Affiliation': 'Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Joop', 'Initials': 'J', 'LastName': 'Laven', 'Affiliation': 'Division Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Erasmus MC, Rotterdam, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0233876']
1208,32480307,Prolonged-release melatonin in Parkinson's disease patients with a poor sleep quality: A randomized trial.,"BACKGROUND


The present study was a randomized, double-blind, placebo-controlled, multi-center trial to evaluate the efficacy and safety of prolonged-release melatonin (PRM) in Parkinson's disease (PD) patients with poor sleep quality.
METHODS


PD patients with a global Pittsburgh Sleep Quality Index (PSQI) score > 5 were included. Patients were assessed using the PSQI, a rapid eye movement sleep behavior disorder screening questionnaire, the Epworth Sleepiness Scale, Non-Motor Symptoms Scale (NMSS), Parkinson's Disease Quality of Life-39 (PDQ-39), and Unified Parkinson's Disease Rating Scale (UPDRS)-III at the beginning of the study and after 4 weeks of treatment with 2 mg of PRM. Partial correlation analysis was performed to investigate the relationship between PSQI score and the other scales.
RESULTS


Thirty-four PD patients with poor sleep quality were enrolled and divided into 2 groups based on medication; PRM (n = 16) and placebo (n = 18). Regarding efficacy, PSQI was significantly improved in the PRM group compared to the control group. Improvement in the NMSS and PDQ-39 summary index were observed in the PRM but not in the placebo group; UPDRS-III score was not significantly changed in either group. PSQI improvement correlated with improvement in NMSS score and PDQ-39 summary index. Regarding safety, all enrolled subjects did not complain of side effects due to PRM.
CONCLUSION


PRM is an effective and safe treatment option for subjective sleep quality in PD patients and beneficial effects on sleep quality are associated with improved non-motor symptoms and quality of life in PD patients.",2020,Improvement in the NMSS and PDQ-39 summary index were observed in the PRM but not in the placebo group; UPDRS-III score was not significantly changed in either group.,"['PD patients with a global Pittsburgh Sleep Quality Index (PSQI) score', 'Thirty-four PD patients with poor sleep quality', ""Parkinson's disease (PD) patients with poor sleep quality"", '\xa05 were included', ""Parkinson's disease patients with a poor sleep quality""]","['Prolonged-release melatonin', 'prolonged-release melatonin (PRM', 'PRM', 'placebo']","['subjective sleep quality', ""PSQI, a rapid eye movement sleep behavior disorder screening questionnaire, the Epworth Sleepiness Scale, Non-Motor Symptoms Scale (NMSS), Parkinson's Disease Quality of Life-39 (PDQ-39), and Unified Parkinson's Disease Rating Scale"", 'efficacy, PSQI', 'NMSS and PDQ-39 summary index', 'efficacy and safety', 'NMSS score and PDQ-39 summary index', 'UPDRS-III score']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0751772', 'cui_str': 'REM sleep behavior disorder'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439070', 'cui_str': 'III'}]",,0.0488383,Improvement in the NMSS and PDQ-39 summary index were observed in the PRM but not in the placebo group; UPDRS-III score was not significantly changed in either group.,"[{'ForeName': 'Jong Hyeon', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': 'Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; Neuroscience Center, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Minkyeong', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; Neuroscience Center, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Suyeon', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Biostatistics, Soonchunhyang University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Wooyoung', 'Initials': 'W', 'LastName': 'Jang', 'Affiliation': 'Department of Neurology, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Republic of Korea.'}, {'ForeName': 'Jinse', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Haeundae Paik Hospital, Inje University, Busan, Republic of Korea.'}, {'ForeName': 'Eungseok', 'Initials': 'E', 'LastName': 'Oh', 'Affiliation': 'Department of Neurology, Chungnam National University Hospital, College of Medicine, Daejun, Republic of Korea.'}, {'ForeName': 'Jin Whan', 'Initials': 'JW', 'LastName': 'Cho', 'Affiliation': 'Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; Neuroscience Center, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; Neuroscience Center, Samsung Medical Center, Seoul, Republic of Korea. Electronic address: sunnyfor@hanmail.net.'}, {'ForeName': 'Jinyoung', 'Initials': 'J', 'LastName': 'Youn', 'Affiliation': 'Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; Neuroscience Center, Samsung Medical Center, Seoul, Republic of Korea. Electronic address: genian@skku.edu.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.03.029']
1209,32480319,Effectiveness of an app-based cognitive behavioral therapy program for postpartum depression in primary care: A randomized controlled trial.,"OBJECTIVE


The objective of this study was to examine the effect of mobile phone applications (App) based cognitive behavioral therapy (CBT) on postpartum depression.
METHOD


A non-blinded parallel-group randomized controlled trial was conducted. The study population consisted of women attended to three health care centers in Kerman, Iran. Participants were recruited between September and November 2018, and randomized 1:1 to either the intervention group (mobile application access) or control group (no mobile application access). All participants completed the Edinburgh Postnatal Depression Scale (EPDS) at the baseline and 2 months after baseline. Data were analyzed using inferential statistics including chi-square, independent sample t-test, paired t-test and linear regression.
RESULTS


A total of 75 women with an average age of 27 years participated in this study. Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001). However, in the intervention group, the average EPDS score after intervention was 8.18 and in the control group was 15.05, which was statistically significant (p < 0.001).
CONCLUSION


These findings provide proof that providing a CBT program using a mobile application can lead to clinically important improvements in outcomes for mothers who suffer from postpartum depression.",2020,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","['Participants were recruited between September and November 2018', 'postpartum depression in primary care', 'women attended to three health care centers in Kerman, Iran', 'mothers who suffer from postpartum depression', '75 women with an average age of 27 years participated in this study']","['intervention group (mobile application access) or control group (no mobile application access', 'app-based cognitive behavioral therapy program', 'mobile phone applications (App) based cognitive behavioral therapy (CBT']","['Edinburgh Postnatal Depression Scale (EPDS', 'average EPDS score', 'EPDS score']","[{'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score'}]",75.0,0.174326,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Jannati', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Mazhari', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Ahmadian', 'Affiliation': 'Medical Informatics Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: ahmadianle@yahoo.com.'}, {'ForeName': 'Moghaddameh', 'Initials': 'M', 'LastName': 'Mirzaee', 'Affiliation': 'Epidemiology and Biostatistics, Kerman University of Medical Sciences, Kerman, Iran.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104145']
1210,32481623,Changes in Thyroid and Glycemic Status and Food Intake in Children with Excess Weight Who Were Submitted for a Multi-Component School Intervention for 16 Months.,"We investigated if children with excess weight who submitted to two types of intervention at school for 16 months showed improvements in thyroid and glycemic function and food intake. Children (8-11 years) with a body mass index-for-age (BMI/A) of ≥1 Z score were divided into two groups: Treatment 1 ( n  = 73) involved motivation to adopt healthier lifestyle; Treatment 2 ( n  = 103) involved performing weekly nutritional education, motivational, and physical activities at school. A semi-quantitative food frequency questionnaire was used. The delta BMI/A were similar after 16 months; Treatment 1 showed higher decrease in thyroid-stimulating hormone (TSH; median (range)): -0.45 (-3.19 to 2.17) and 0.06 (-4.57 to 1.63) mIU/L,  p  = 0.001), FreeT3 (-0.46 (-2.92 to 1.54) and -0.15 (-2.46 to 1.38) pmol/L,  p  = 0.038), and FreeT4 -1.41 (-6.18 to 3.47) and -0.90 (-4.89 to 2.96) pmol/L,  p  = 0.018), followed by decrease in energy intake (7304 (6806 to 7840) and 8267 (7739 to 8832) kJ,  P treatment = 0.439,  P time <0.001, interaction group-time  p  < 0.001), macronutrients and sugar. A positive correlation between FreeT3 and BMI/A, and a negative correlation with FreeT4 and insulin were found at baseline (r 0.212,  p  < 0.01; r -0.155,  p  < 0.01, respectively) and follow-up (r 0.222,  p  < 0.01; r -0.221,  p  < 0.01). The decrease in overall diet and particularly sugar intake was accompanied by a greater reduction in TSH and FreeT3 in Treatment 1, demonstrating the impact of dietary intake on thyroid function.",2020,"The delta BMI/A were similar after 16 months; Treatment 1 showed higher decrease in thyroid-stimulating hormone (TSH; median (range)): -0.45 (-3.19 to 2.17) and 0.06 (-4.57 to 1.63) mIU/L,  p  = 0.001), FreeT3 (-0.46 (-2.92 to 1.54) and -0.15","['Children with Excess Weight', 'children with excess weight who submitted to two types of intervention at school for 16 months', 'Children (8-11 years) with a body mass index-for-age (BMI/A) of ≥1 Z score']","['motivation to adopt healthier lifestyle; Treatment 2 ( n  = 103) involved performing weekly nutritional education, motivational, and physical activities at school']","['Thyroid and Glycemic Status and Food Intake', 'thyroid-stimulating hormone', 'thyroid and glycemic function and food intake', 'overall diet and particularly sugar intake', 'energy intake']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0204934', 'cui_str': 'Nutrition education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0556234', 'cui_str': 'Sugar intake'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",,0.0203566,"The delta BMI/A were similar after 16 months; Treatment 1 showed higher decrease in thyroid-stimulating hormone (TSH; median (range)): -0.45 (-3.19 to 2.17) and 0.06 (-4.57 to 1.63) mIU/L,  p  = 0.001), FreeT3 (-0.46 (-2.92 to 1.54) and -0.15","[{'ForeName': 'Vinicius J B', 'Initials': 'VJB', 'LastName': 'Martins', 'Affiliation': 'Department of Physiology and Pathology, Federal University of Paraíba, Health Sciences Center, Campus I, Cidade Universitária, João Pessoa, PB 58051-900, Brazil.'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Filgueiras', 'Affiliation': 'Department of Physiology, Federal University of São Paulo, Rua Botucatu, 862, Edifício de Ciências Biomédicas, 2 andar, São Paulo, SP 04023-060, Brazil.'}, {'ForeName': 'Viviane B P', 'Initials': 'VBP', 'LastName': 'Almeida', 'Affiliation': 'Department of Physiology, Federal University of São Paulo, Rua Botucatu, 862, Edifício de Ciências Biomédicas, 2 andar, São Paulo, SP 04023-060, Brazil.'}, {'ForeName': 'Rúbia C S', 'Initials': 'RCS', 'LastName': 'de Moraes', 'Affiliation': 'Department of Nutrition, Federal University of Paraíba, Health Sciences Center, Campus I, Cidade Universitária, João Pessoa, PB 58051-900, Brazil.'}, {'ForeName': 'Ana L', 'Initials': 'AL', 'LastName': 'Sawaya', 'Affiliation': 'Department of Physiology, Federal University of São Paulo, Rua Botucatu, 862, Edifício de Ciências Biomédicas, 2 andar, São Paulo, SP 04023-060, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph17113825']
1211,32482525,A Randomized Parallel Controlled Phase II Trial of Recombinant Human Endostatin Added to Neoadjuvant Chemotherapy for Stage III Breast Cancer.,"BACKGROUND


To explore the potential advantage of preoperative anti-angiogenosis therapy, we implemented a study to evaluate the efficacy of recombinant human endostatin (EN) in combination with neoadjuvant chemotherapy in the treatment of stage III breast cancer.
PATIENTS AND METHODS


Eighty-seven patients were randomized to neoadjuvant TEC (docetaxel, epirubicin, and cyclophosphamide) or to EN+TEC, followed by surgery. The primary endpoint was the objective response rate (ORR). Secondary endpoints included pathologic complete response (pCR), relapse-free survival (RFS), overall survival (OS), and safety.
RESULTS


Patients receiving EN+TEC achieved significantly higher ORR (81.82%; 36/44) compared with those receiving TEC (58.14%; 25/43; P=0.016). There was a non-significant trend of increased pCR with EN treatment (15.91% vs. 6.98%). The median follow-up was 54 months and revealed a significantly higher RFS with EN+TEC (median, 67.3 months; 95% confidence interval [CI], 61.0-73.7 months), compared with TEC (median, 55.0 months; 95% CI, 48.3-61.7 months; P =0.014). EN+TEC also significantly improved OS (74.2 months; 95% CI, 68.9-79.6 months), compared with TEC (59.1 months; 95% CI, 52.0-66.1 months; P =0 .006). The 3- and 5-year OS rates are estimated to be 88.5% and 82.8% with EN+TEC and 76.7% and 54.4% with TEC, respectively. Cox proportional regression analyses showed that EN+TEC was associated with improved OS (hazard ratio, 0.377; 95% CI, 0.418-0.959; P =0 .041). There was no significant difference in adverse events between EN+TEC and TEC.
CONCLUSION


The combination of EN+TEC neoadjuvant chemotherapy significantly improved the ORR and OS, suggesting a benefit of adding anti-angiogenesis to standard chemotherapy in the treatment of locally advanced breast cancer.",2020,"Cox proportional regression analyses showed that EN+TEC was associated with improved OS (hazard ratio, 0.377; 95% CI, 0.418-0.959; P =0","['locally advanced breast cancer', 'Stage III Breast Cancer', 'stage III breast cancer', 'Eighty-seven patients']","['neoadjuvant TEC (docetaxel, epirubicin, and cyclophosphamide) or to EN+TEC, followed by surgery', 'Recombinant Human Endostatin Added to Neoadjuvant Chemotherapy', 'recombinant human endostatin (EN', 'preoperative anti-angiogenosis therapy', 'neoadjuvant chemotherapy']","['OS', 'objective response rate (ORR', 'ORR and OS', 'ORR', '3- and 5-year OS rates', 'adverse events', 'pathologic complete response (pCR), relapse-free survival (RFS), overall survival (OS), and safety']","[{'cui': 'C3495949', 'cui_str': 'Locally advanced breast cancer'}, {'cui': 'C4721421', 'cui_str': 'Breast cancer stage III'}, {'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0229951', 'cui_str': 'Thymic epithelial cell'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0534628', 'cui_str': 'Endostatin'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",87.0,0.0599547,"Cox proportional regression analyses showed that EN+TEC was associated with improved OS (hazard ratio, 0.377; 95% CI, 0.418-0.959; P =0","[{'ForeName': 'Xiangmei', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Research Center, Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Zhenzhen', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'OHSU-PSU School of Public Health, Oregon Health and Science University, Portland, OR.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Cao', 'Affiliation': 'Breast Center, Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Beichen', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Motomi', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Shiuh-Wen', 'Initials': 'SW', 'LastName': 'Luoh', 'Affiliation': 'Division of Hematology and Medical Oncology, Knight Cancer Institute, Oregon Health and Science University, Portland, OR.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Bergan', 'Affiliation': 'Division of Hematology/Oncology, Knight Cancer Institute, Oregon Health and Science University, Portland, OR.'}, {'ForeName': 'Yueping', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Pathology, Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Yunjiang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Breast Center, Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China. Electronic address: lyj818326@outlook.com.'}]",Clinical breast cancer,['10.1016/j.clbc.2020.04.009']
1212,32486007,No Significant Differences in Muscle Growth and Strength Development When Consuming Soy and Whey Protein Supplements Matched for Leucine Following a 12 Week Resistance Training Program in Men and Women: A Randomized Trial.,"There are conflicting reports regarding the efficacy of plant versus animal-derived protein to support muscle and strength development with resistance training. The purpose of this study was to determine whether soy and whey protein supplements matched for leucine would comparably support strength increases and muscle growth following 12 weeks of resistance training. Sixty-one untrained young men ( n  = 19) and women ( n  = 42) (18-35 year) enrolled in this study, and 48 completed the trial (17 men, 31 women). All participants engaged in supervised resistance training 3×/week and consumed 19 grams of whey protein isolate or 26 grams of soy protein isolate, both containing 2 g (grams) of leucine. Multi-level modeling indicated that total body mass (0.68 kg; 95% CI: 0.08, 1.29 kg;  p  < 0.001), lean body mass (1.54 kg; 95% CI: 0.94, 2.15 kg;  p  < 0.001), and peak torque of leg extensors (40.27 Nm; 95% CI: 28.98, 51.57 Nm,  p  < 0.001) and flexors (20.44 Nm; 95% CI: 12.10, 28.79 Nm;  p  < 0.001) increased in both groups. Vastus lateralis muscle thickness tended to increase, but this did not reach statistical significance (0.12 cm; 95% CI: -0.01, 0.26 cm;  p  = 0.08). No differences between groups were observed ( p  > 0.05). These data indicate that increases in lean mass and strength in untrained participants are comparable when strength training and supplementing with soy or whey matched for leucine.",2020,"Vastus lateralis muscle thickness tended to increase, but this did not reach statistical significance (0.12 cm; 95% CI: -0.01, 0.26 cm;  p  = 0.08).","['Sixty-one untrained young men ( n  = 19) and women ( n  = 42) (18-35 year) enrolled in this study, and 48 completed the trial (17 men, 31 women', 'untrained participants', 'Men and Women']","['Resistance Training Program', 'soy and whey protein supplements matched for leucine', 'supervised resistance training 3×/week and consumed 19 grams of whey protein isolate or 26 grams of soy protein isolate, both containing 2 g (grams) of leucine', 'Consuming Soy and Whey Protein Supplements Matched for Leucine']","['lean mass and strength', 'total body mass', 'lean body mass', 'Vastus lateralis muscle thickness', 'Muscle Growth and Strength Development', 'peak torque of leg extensors']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0677666', 'cui_str': 'soy protein isolate'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",61.0,0.0891844,"Vastus lateralis muscle thickness tended to increase, but this did not reach statistical significance (0.12 cm; 95% CI: -0.01, 0.26 cm;  p  = 0.08).","[{'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Lynch', 'Affiliation': 'Department of Kinesiology, Point Loma Nazarene University, San Diego, CA 92106, USA.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Buman', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Dickinson', 'Affiliation': 'Health Sciences, Central Washington University, Ellensburg, WA, 98926, USA.'}, {'ForeName': 'Lynda B', 'Initials': 'LB', 'LastName': 'Ransdell', 'Affiliation': 'College of Health and Human Services, Northern Arizona University, Flagstaff, AZ 86011, USA.'}, {'ForeName': 'Carol S', 'Initials': 'CS', 'LastName': 'Johnston', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Wharton', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ 85004, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17113871']
1213,32580032,Design of a cluster-randomized trial of the effectiveness and cost-effectiveness of metformin on prevention of type 2 diabetes among prediabetic Mexican adults (the PRuDENTE initiative of Mexico City).,"INTRODUCTION


Type 2 diabetes (T2D) is a global epidemic, and nations are struggling to implement effective healthcare strategies to reduce the burden. While efficacy studies demonstrate that metformin can reduce incident T2D by half among younger, obese adults with prediabetes, its real-world effectiveness are understudied, and its use for T2D prevention in primary care is low. We describe the design of a pragmatic trial to evaluate the incremental effectiveness of metformin, as an adjunct to a simple lifestyle counseling.
METHODS


The ""Prevención de la Diabetes con Ejercicio, Nutrición y Tratamiento"" [Diabetes Prevention with Exercise, Nutrition and Treatment; PRuDENTE, (Spanish acronym)] is a cluster-randomized trial in Mexico City's public primary healthcare system. The study randomly assigns 51 clinics to deliver one of two interventions for 36 months: 1) lifestyle only; 2) lifestyle plus metformin, to 3060 patients ages 30-65 with impaired fasting glucose and obesity. The primary endpoint is incident T2D (fasting glucose ≥126 mg/dL, or HbA1c ≥6.5%). We will also measure a range of implementation-related process outcomes at the clinic-, clinician- and patient-levels to inform interpretations of effectiveness and enable efforts to refine, adapt, adopt and disseminate the model. We will also estimate the cost-effectiveness of metformin as an adjunct to lifestyle counseling in Mexico.
DISCUSSION


Findings from this pragmatic trial will generate new translational knowledge in Mexico and beyond, both with respect to metformin's real-world effectiveness among an 'at-risk' population, and uncovering facilitators and barriers to the reach, adoption and implementation of metformin preventive therapy in public primary care settings.
TRIAL REGISTRATION


This trial is registered at Clinicaltrials.gov (NCT03194009).",2020,Nutrición y,"['prediabetic Mexican adults (the PRuDENTE initiative of Mexico City', '3060 patients ages 30-65 with impaired fasting glucose and obesity', 'Nutrición y']","['lifestyle only; 2) lifestyle plus metformin', 'metformin']","['incident T2D (fasting glucose ≥126\u202fmg/dL, or HbA1c ≥6.5']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1272092', 'cui_str': 'Impaired fasting glycaemia'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",3060.0,0.0429361,Nutrición y,"[{'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Rodríguez', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA. Electronic address: Luis.Rodriguez@ucsf.edu.'}, {'ForeName': 'Simón', 'Initials': 'S', 'LastName': 'Barquera', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Aguilar-Salinas', 'Affiliation': 'Division of Nutrition, Salvador Zubiran National Institute of Medical Sciences and Nutrition, Mexico City, Mexico.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Sepúlveda-Amor', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA; Institute for Global Health Sciences, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Luz María', 'Initials': 'LM', 'LastName': 'Sánchez-Romero', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Denova-Gutiérrez', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Nydia', 'Initials': 'N', 'LastName': 'Balderas', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'Moreno-Loaeza', 'Affiliation': 'Research Unit on Metabolic Diseases, Salvador Zubiran National Institute of Medical Sciences and Nutrition, Mexico City, Mexico; Medical, Dental and Health Sciences, National Autonomous University of Mexico, Mexico City, Mexico.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Handley', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA; Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, USA; UCSF Center for Vulnerable Populations, San Francisco General Hospital, San Francisco, CA, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Department of Medicine, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Oliva', 'Initials': 'O', 'LastName': 'López-Arellano', 'Affiliation': 'Ministry of Health, Mexico City, Mexico.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Gallardo-Hernández', 'Affiliation': 'Ministry of Health, Mexico City, Mexico.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Schillinger', 'Affiliation': 'Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, USA; UCSF Center for Vulnerable Populations, San Francisco General Hospital, San Francisco, CA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106067']
1214,32446880,Changes in parental feeding practices and preschoolers' food intake following a randomized controlled childhood obesity trial.,"Childhood obesity treatment involving parents is most effective during the preschool age. However, the mechanisms of change are not known. The present study reports on secondary outcomes (changes in parental feeding practices and child food intake) of early obesity treatment. The More and Less study is a randomized controlled trial conducted in Stockholm County, Sweden. Children with obesity (n = 174, mean BMI SDS 3.0, mean age 5 years, 56% girls) and their parents (60% with foreign background, 40% with a university degree) were randomized to: 1) standard treatment focusing on lifestyle recommendations (ST), 2) a parent support program with boosters (PGB), and 3) a parent support program without boosters (PGNB). The Child Feeding Questionnaire (CFQ) was used to measure parental feeding practices. Child food intake was assessed with a Food Frequency Questionnaire (FFQ). We calculated the monthly changes in CFQ practices and FFQ items based on four measurements. We did not find any significant between-group differences in parental feeding practices and child food intake over time. However, general linear models showed that changes in certain feeding practices predicted changes in child food intake. When ST was compared to the parent support groups, some associations moved in opposite directions. For example, increasing maternal restriction predicted increased consumption of cookies/buns in PGNB (b = 2.3, p < 0.05) and decreased consumption of cookies/buns in ST (b = -2.1, p < 0.05). This is among the few studies to examine the effect of parental feeding practices on child food intake and weight status after obesity treatment among preschoolers. We found no evidence that changes in feeding practices or changes in child food intake mediated child weight loss. Future studies should consider other intermediary processes related to general parenting practices and parent-child interactions.",2020,We did not find any significant between-group differences in parental feeding practices and child food habits over time.,"['Children with obesity (n\u202f=\u202f174, mean BMI SDS 3.0, mean age 5 years, 56% girls) and their parents (60% with foreign background, 40% with a university degree', 'child food habits and weight status after obesity treatment among preschoolers', 'Stockholm County, Sweden']","['standard treatment focusing on lifestyle recommendations (ST), 2) a parent support program with boosters (PGB), and 3) a parent support program without boosters (PGNB', 'parental feeding practices']","['Food Frequency Questionnaire (FFQ', 'parental feeding practices and child food habits) of early obesity treatment', 'consumption of cookies/buns in ST', 'Child Feeding Questionnaire (CFQ']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3853210', 'cui_str': 'Cookie'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}]",,0.0264302,We did not find any significant between-group differences in parental feeding practices and child food habits over time.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Somaraki', 'Affiliation': 'Department of Food Studies, Nutrition and Dietetics, Uppsala University, Uppsala, Sweden. Electronic address: maria.somaraki@ikv.uu.se.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Eli', 'Affiliation': 'Unit for Biocultural Variation and Obesity, School of Anthropology and Museum Ethnography, University of Oxford, Oxford, UK; Social Science and Systems in Health, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK. Electronic address: karin.eli@anthro.ox.ac.uk.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Sorjonen', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Solna, Sweden. Electronic address: kimmo.sorjonen@ki.se.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ek', 'Affiliation': 'Division of Pediatrics, Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden. Electronic address: anna.ek@ki.se.'}, {'ForeName': 'Pernilla', 'Initials': 'P', 'LastName': 'Sandvik', 'Affiliation': 'Department of Food Studies, Nutrition and Dietetics, Uppsala University, Uppsala, Sweden. Electronic address: pernilla.sandvik@ikv.uu.se.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Nowicka', 'Affiliation': 'Department of Food Studies, Nutrition and Dietetics, Uppsala University, Uppsala, Sweden; Division of Pediatrics, Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden. Electronic address: paulina.nowicka@ikv.uu.se.'}]",Appetite,['10.1016/j.appet.2020.104746']
1215,32448790,10-Valent pneumococcal non-typeable  H. influenzae  protein D conjugate vaccine (PHiD-CV10) versus 13-valent pneumococcal conjugate vaccine (PCV13) as a booster dose to broaden and strengthen protection from otitis media (PREVIX_BOOST) in Australian Aboriginal children: study protocol for a randomised controlled trial.,"INTRODUCTION


Streptococcus pneumoniae  and non-typeable  Haemophilus influenzae  (NTHi) are major otitis media pathogens that densely co-colonise the nasopharynx and infect the middle ear of Australian Aboriginal infants from very early in life. Our co-primary hypotheses are that at 18 months of age infants receiving 10-valent pneumococcal  Haemophilus influenzae  protein D conjugate vaccine (PHiD-CV10) compared with those receiving 13-valent pneumococcal conjugate vaccine (PCV13) as a booster at 12 months of age will have higher antibody levels to  Haemophilus influenzae  protein D and that infants receiving PCV13 will have higher antibody levels to PCV13-only serotypes 3, 6A and 19A.
METHODS AND ANALYSES


Our randomised controlled trial will enrol 270 Aboriginal children at 12 months of age to a booster dose of either PHiD-CV10 or PCV13. Children who completed the three-dose primary course schedules of PHiD-CV10 at 2, 4, 6 months of age; PCV13 at 2, 4, 6 months of age; or a combination schedule of PHiD-CV10 at 1, 2, 4 months of age plus PCV13 at 6 months of age are eligible. The co-primary assessor-blinded outcomes when the infants are 18 months of age are as follows: (a) IgG geometric mean concentration (GMC) and proportion with IgG ≥100 EU/mL for protein D, and (b) IgG GMC and the proportion with IgG ≥0.35 µg/mL for pneumococcal serotypes 3, 6A and 19A. Secondary immunogenicity comparisons of six primary and booster dose schedules of 10 shared serotypes at 18 months of age, nasopharyngeal carriage, all forms of otitis media, hearing loss and developmental milestones at 18, 24, 30 and 36 months of age will be reported.
ETHICS AND DISSEMINATION


Ethics committees of NT Department of Health, Menzies, WA Department of Health and WA Aboriginal Health approved the study. Results will be presented to communities, at conferences and published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT01735084.",2020,"Children who completed the three-dose primary course schedules of PHiD-CV10 at 2, 4, 6 months of age; PCV13 at 2, 4, 6 months of age; or a combination schedule of PHiD-CV10 at 1, 2, 4 months of age plus PCV13 at 6 months of age are eligible.","['Australian Aboriginal children', '270 Aboriginal children at 12 months of age to a booster dose of either', 'infants are 18\u2009months of age are as follows: (a) IgG geometric mean concentration (GMC) and proportion with IgG ≥100 EU/mL for protein D, and (b) IgG GMC and the proportion with IgG ≥0.35\u2009µg/mL for pneumococcal serotypes 3, 6A and 19A. Secondary immunogenicity comparisons of six primary and booster dose schedules of 10 shared serotypes at 18 months of age, nasopharyngeal carriage, all forms of otitis media, hearing loss and developmental milestones at 18, 24, 30 and 36 months of age will be reported']","['13-valent pneumococcal conjugate vaccine (PCV13', 'Streptococcus pneumoniae  and non-typeable  Haemophilus influenzae  (NTHi', 'PHiD-CV10 or PCV13', '10-Valent pneumococcal non-typeable  H. influenzae  protein D conjugate vaccine (PHiD-CV10) versus 13-valent pneumococcal conjugate vaccine (PCV13']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1532292', 'cui_str': 'Ehrlich units/milliliter'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0029882', 'cui_str': 'Otitis media'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C3152625', 'cui_str': 'Pneumococcal 13-valent conjugate vaccine'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0018483', 'cui_str': 'Haemophilus influenzae'}, {'cui': 'C1864445', 'cui_str': 'Histiocytosis-lymphadenopathy plus syndrome'}, {'cui': 'C0450819', 'cui_str': 'CV10'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}]",[],270.0,0.230418,"Children who completed the three-dose primary course schedules of PHiD-CV10 at 2, 4, 6 months of age; PCV13 at 2, 4, 6 months of age; or a combination schedule of PHiD-CV10 at 1, 2, 4 months of age plus PCV13 at 6 months of age are eligible.","[{'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Oguoma', 'Affiliation': 'Child Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Wilson', 'Affiliation': 'Child Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Mulholland', 'Affiliation': 'Infection and Immunity: Pneumococcal Research, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.'}, {'ForeName': 'Mathuram', 'Initials': 'M', 'LastName': 'Santosham', 'Affiliation': 'Center American Indian Health, John Hopkins School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Torzillo', 'Affiliation': 'Respiratory Medicine, Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McIntyre', 'Affiliation': 'Director, National Centre for Immunisation Research and Surveillance, Sydney, New South Wales, Australia.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Smith-Vaughan', 'Affiliation': 'Child Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Balloch', 'Affiliation': 'Pneumococcal Immunology, Murdoch Childrens Research Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Chatfield', 'Affiliation': 'Cerebral Palsy and Rehabilitation Research Centre, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Lehmann', 'Affiliation': 'Division of Population Sciences, Telethon Institute for Child Health Research, West Perth, Western Australia, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Binks', 'Affiliation': 'Child Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': 'Child Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Carapetis', 'Affiliation': 'Director, Telethon Kids Institute, Perth, Western Australia, Australia.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Krause', 'Affiliation': 'Centre for Disease Control, Department of Health, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Andrews', 'Affiliation': 'Child Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Snelling', 'Affiliation': 'Infectious Disease Implementation Research Team, Princess Margaret Hospital for Children, Perth, Western Australia, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Licciardi', 'Affiliation': 'Infections and Immunity: Pneumococcal Research, Murdoch Childrens Research Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Morris', 'Affiliation': 'Child Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Amanda Jane', 'Initials': 'AJ', 'LastName': 'Leach', 'Affiliation': 'Child Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia amanda.leach@menzies.edu.au.'}]",BMJ open,['10.1136/bmjopen-2019-033511']
1216,32448796,Study protocol for the antidepressant advisor (ADeSS): a decision support system for antidepressant treatment for depression in UK primary care: a feasibility study.,"INTRODUCTION


The Antidepressant Advisor Study is a feasibility trial of a computerised decision-support tool which uses an algorithm to provide antidepressant treatment guidance for general practitioners (GPs) in the UK primary care service. The tool is the first in the UK to implement national guidelines on antidepressant treatment guidance into a computerised decision-support tool.
METHODS AND ANALYSIS


The study is a parallel group, cluster-randomised controlled feasibility trial where participants are blind to treatment allocation. GPs were assigned to two treatment arms: (1) treatment-as-usual (TAU) and (2) computerised decision-support tool to assist with antidepressant choices. The study will assess recruitment and lost to follow-up rates, GP satisfaction with the tool and impact on health service use. A meaningful long-term roll-out unit cost will be calculated for the tool, and service use data will be collected at baseline and follow-up to inform a full economic evaluation of a future trial.
ETHICS AND DISSEMINATION


The study has received National Health Service ethical approval from the London-Camberwell St Giles Research Ethics Committee (ref: 17/LO/2074). The trial was pre-registered in the Clinical Trials.gov registry. The results of the study will be published in a pre-publication archive within 1 year of completion of the last follow-up assessment.
TRIAL REGISTRATION NUMBER


NCT03628027.",2020,"The tool is the first in the UK to implement national guidelines on antidepressant treatment guidance into a computerised decision-support tool.
","['depression in UK primary care', 'general practitioners (GPs) in the UK primary care service']","['treatment-as-usual (TAU) and (2) computerised decision-support tool to assist with antidepressant choices', 'antidepressant advisor (ADeSS']",[],"[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]",[],,0.105514,"The tool is the first in the UK to implement national guidelines on antidepressant treatment guidance into a computerised decision-support tool.
","[{'ForeName': 'Phillippa', 'Initials': 'P', 'LastName': 'Harrison', 'Affiliation': ""Centre for Affective Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Ewan', 'Initials': 'E', 'LastName': 'Carr', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Goldsmith', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Allan H', 'Initials': 'AH', 'LastName': 'Young', 'Affiliation': ""Centre for Affective Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ashworth', 'Affiliation': ""Department of Population Health Sciences, King's College London, London, UK.""}, {'ForeName': 'Diede', 'Initials': 'D', 'LastName': 'Fennema', 'Affiliation': ""Centre for Affective Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Barrett', 'Affiliation': ""Department of Health Services & Population Research, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Zahn', 'Affiliation': ""Centre for Affective Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK Roland.zahn@kcl.ac.uk.""}]",BMJ open,['10.1136/bmjopen-2019-035905']
1217,32459669,"Use of real-time visual feedback during overground walking training on gait symmetry and velocity in patients with post-stroke hemiparesis: randomized controlled, single-blind study.","This study aimed to determine the efficacy of using real-time visual feedback during overground walking training to improve walking function in patients with post-stroke hemiparesis. Twenty-four patients with post-stroke hemiparesis who were able to walk independently under less impact of synergy pattern on the affected lower limbs (Brunnstrom stage IV or V) were randomly assigned to either the experimental group or the control group. All subjects performed overground walking for 30 min, three times a week for 6 weeks, with real-time visual feedback (weight load to the affected lower limb) provided during training for subjects in the experimental group. Outcome measures comprised the timed up-and-go test and gait parameters (step length, stride length, single and double support times, step and stride length ratios, and single support time ratio). In between-group comparison, the changes between pre-test and post-test scores in all parameters were significantly greater in the experimental group than in the control group (P < 0.05), except for double support time and step length ratio. Furthermore, post-test values of all parameters were significantly more improved in the experimental group than in the control group (P < 0.05). Our findings suggest that real-time visual feedback may be an advantageous therapeutic adjunct to reinforce the effects of overground walking training in patients with post-stroke hemiparesis.",2020,"In between-group comparison, the changes between pre-test and post-test scores in all parameters were significantly greater in the experimental group than in the control group (P < 0.05), except for double support time and step length ratio.","['Twenty-four patients with post-stroke hemiparesis who were able to walk independently under less impact of synergy pattern on the affected lower limbs (Brunnstrom stage IV or V', 'patients with post-stroke hemiparesis']","['overground walking training', 'real-time visual feedback during overground walking training']","['gait symmetry and velocity', 'walking function', 'timed up-and-go test and gait parameters (step length, stride length, single and double support times, step and stride length ratios, and single support time ratio', 'double support time and step length ratio']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C2712089', 'cui_str': 'Able to walk'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1264675', 'cui_str': 'Time ratio'}]",24.0,0.0246643,"In between-group comparison, the changes between pre-test and post-test scores in all parameters were significantly greater in the experimental group than in the control group (P < 0.05), except for double support time and step length ratio.","[{'ForeName': 'Jin-Seop', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, College of Health Science, Sunmoon University, 70 Sumoon-ro 221 Beon-Gil, Tangjeong-Myeon, Asan-Si, Chungcheongnam-do.'}, {'ForeName': 'Duck-Won', 'Initials': 'DW', 'LastName': 'Oh', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Cheongju University, 298 Daeseong-ro, Cheongwon-gu, Cheongju, Chungcheongbuk-do, Republic of Korea.'}]",International journal of rehabilitation research. Internationale Zeitschrift fur Rehabilitationsforschung. Revue internationale de recherches de readaptation,['10.1097/MRR.0000000000000419']
1218,31388184,Diagnosis of epithelial ovarian cancer using a combined protein biomarker panel.,"BACKGROUND


An early detection tool for EOC was constructed from analysis of biomarker expression data from serum collected during the UKCTOCS.
METHODS


This study included 49 EOC cases (19 Type I and 30 Type II) and 31 controls, representing 482 serial samples spanning seven years pre-diagnosis. A logit model was trained by analysis of dysregulation of expression data of four putative biomarkers, (CA125, phosphatidylcholine-sterol acyltransferase, vitamin K-dependent protein Z and C-reactive protein); by scoring the specificity associated with dysregulation from the baseline expression for each individual.
RESULTS


The model is discriminatory, passes k-fold and leave-one-out cross-validations and was further validated in a Type I EOC set. Samples were analysed as a simulated annual screening programme, the algorithm diagnosed cases with >30% PPV 1-2 years pre-diagnosis. For Type II cases (~80% were HGS) the algorithm classified 64% at 1 year and 28% at 2 years tDx as severe.
CONCLUSIONS


The panel has the potential to diagnose EOC one-two years earlier than current diagnosis. This analysis provides a tangible worked example demonstrating the potential for development as a screening tool and scrutiny of its properties. Limits on interpretation imposed by the number of samples available are discussed.",2019,"The model is discriminatory, passes k-fold and leave-one-out cross-validations and was further validated in a Type I EOC set.","['For Type II cases (~80% were HGS', '49 EOC cases (19 Type I and 30 Type II) and 31 controls, representing 482 serial samples spanning seven years pre-diagnosis']",[],[],"[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1568891', 'cui_str': 'HGS protein, human'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",[],[],49.0,0.0221786,"The model is discriminatory, passes k-fold and leave-one-out cross-validations and was further validated in a Type I EOC set.","[{'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Russell', 'Affiliation': 'Stoller Biomarker Discovery Centre and Manchester Molecular Pathology Innovation Centre, Division of Cancer Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Ciaren', 'Initials': 'C', 'LastName': 'Graham', 'Affiliation': 'School of Biological Sciences, Queens University Belfast, Chlorine Gardens, Belfast, BT9 5DL, UK.'}, {'ForeName': 'Alfonsina', 'Initials': 'A', 'LastName': ""D'Amato"", 'Affiliation': 'Department of Pharmaceutical Sciences, University of Milan, Milano, Lombardy, Italy.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Gentry-Maharaj', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, Faculty of Population Health Sciences, University College London, London, UK.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Ryan', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, Faculty of Population Health Sciences, University College London, London, UK.'}, {'ForeName': 'Jatinderpal K', 'Initials': 'JK', 'LastName': 'Kalsi', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, Faculty of Population Health Sciences, University College London, London, UK.'}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Whetton', 'Affiliation': 'Stoller Biomarker Discovery Centre and Manchester Molecular Pathology Innovation Centre, Division of Cancer Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Menon', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, Faculty of Population Health Sciences, University College London, London, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Jacobs', 'Affiliation': 'Stoller Biomarker Discovery Centre and Manchester Molecular Pathology Innovation Centre, Division of Cancer Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, UK. i.jacobs@unsw.edu.au.'}, {'ForeName': 'Robert L J', 'Initials': 'RLJ', 'LastName': 'Graham', 'Affiliation': 'School of Biological Sciences, Queens University Belfast, Chlorine Gardens, Belfast, BT9 5DL, UK. r.graham@qub.ac.uk.'}]",British journal of cancer,['10.1038/s41416-019-0544-0']
1219,31388185,Tumour-infiltrating CD8 +  lymphocytes and colorectal cancer recurrence by tumour and nodal stage.,"BACKGROUND


Intratumoural T-cell infiltrate intensity cortes wrelaith clinical outcome in stage II/III colorectal cancer (CRC). We aimed to determine whether this association varies across this heterogeneous group.
METHODS


We performed a pooled analysis of 1804 CRCs from the QUASAR2 and VICTOR trials. Intratumoural CD8 +  and CD3 +  densities were quantified by immunohistochemistry in tissue microarray (TMA) cores, and their association with clinical outcome analysed by Cox regression. We validated our results using publicly available gene expression data in a pooled analysis of 1375 CRCs from seven independent series.
RESULTS


In QUASAR2, intratumoural CD8 +  was a stronger predictor of CRC recurrence than CD3 +  and showed similar discriminative ability to both markers in combination. Pooled multivariable analysis of both trials showed increasing CD8 +  density was associated with reduced recurrence risk independent of confounders including DNA mismatch repair deficiency, POLE mutation and chromosomal instability (multivariable hazard ratio [HR] for each two-fold increase = 0.92, 95%CI = 0.87-0.97, P = 3.6 × 10 -3 ). This association was not uniform across risk strata defined by tumour and nodal stage: absent in low-risk (pT3,N0) cases (HR = 1.03, 95%CI = 0.87-1.21, P = 0.75), modest in intermediate-risk (pT4,N0 or pT1-3,N1-2) cases (HR = 0.92, 95%CI = 0.86-1.0, P = 0.046) and strong in high-risk (pT4,N1-2) cases (HR = 0.87, 95%CI = 0.79-0.97, P = 9.4 × 10 -3 ); P INTERACTION  = 0.090. Analysis of tumour CD8A expression in the independent validation cohort revealed similar variation in prognostic value across risk strata (P INTERACTION  = 0.048).
CONCLUSIONS


The prognostic value of intratumoural CD8 +  cell infiltration in stage II/III CRC varies across tumour and nodal risk strata.",2019,"This association was not uniform across risk strata defined by tumour and nodal stage: absent in low-risk (pT3,N0) cases (HR = 1.03, 95%CI = 0.87-1.21, P = 0.75), modest in intermediate-risk (pT4,N0 or pT1-3,N1-2) cases (HR = 0.92, 95%CI = 0.86-1.0, P = 0.046) and strong in high-risk (pT4,N1-2) cases (HR = 0.87, 95%CI = 0.79-0.97, P = 9.4 × 10 -3 ); P INTERACTION  = 0.090.",['stage II/III colorectal cancer (CRC'],[],"['tumour CD8A expression', 'CRC recurrence', 'Tumour-infiltrating CD8 +  lymphocytes and colorectal cancer recurrence', 'CD8 +  density', 'DNA mismatch repair deficiency, POLE mutation and chromosomal instability', 'Intratumoural CD8 +  and CD3 +  densities']","[{'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]",[],"[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1155661', 'cui_str': 'DNA mismatch repair'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0337815', 'cui_str': 'Poles'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1257806', 'cui_str': 'Chromosome Instability'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}]",1804.0,0.198792,"This association was not uniform across risk strata defined by tumour and nodal stage: absent in low-risk (pT3,N0) cases (HR = 1.03, 95%CI = 0.87-1.21, P = 0.75), modest in intermediate-risk (pT4,N0 or pT1-3,N1-2) cases (HR = 0.92, 95%CI = 0.86-1.0, P = 0.046) and strong in high-risk (pT4,N1-2) cases (HR = 0.87, 95%CI = 0.79-0.97, P = 9.4 × 10 -3 ); P INTERACTION  = 0.090.","[{'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Glaire', 'Affiliation': 'Cancer Genomics and Immunology Group, The Wellcome Centre for Human Genetics, University of Oxford, Roosevelt Drive, Oxford, OX3 7BN, UK.'}, {'ForeName': 'Enric', 'Initials': 'E', 'LastName': 'Domingo', 'Affiliation': 'Cancer Genomics and Immunology Group, The Wellcome Centre for Human Genetics, University of Oxford, Roosevelt Drive, Oxford, OX3 7BN, UK.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Sveen', 'Affiliation': 'Department of Molecular Oncology, Institute for Cancer Research & K.G. Jebsen Colorectal Cancer Research Centre, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jarle', 'Initials': 'J', 'LastName': 'Bruun', 'Affiliation': 'Department of Molecular Oncology, Institute for Cancer Research & K.G. Jebsen Colorectal Cancer Research Centre, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Arild', 'Initials': 'A', 'LastName': 'Nesbakken', 'Affiliation': 'Department of Gastroenterological Surgery & K.G. Jebsen Colorectal Cancer Research Centre, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Nicholson', 'Affiliation': 'Department of Statistics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Novelli', 'Affiliation': 'Department of Histopathology, UCL, Rockefeller Building, University Street, London, WC1E 6JJ, UK.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Lawson', 'Affiliation': 'Department of Histopathology, UCL, Rockefeller Building, University Street, London, WC1E 6JJ, UK.'}, {'ForeName': 'Dahmane', 'Initials': 'D', 'LastName': 'Oukrif', 'Affiliation': 'Department of Histopathology, UCL, Rockefeller Building, University Street, London, WC1E 6JJ, UK.'}, {'ForeName': 'Wanja', 'Initials': 'W', 'LastName': 'Kildal', 'Affiliation': 'Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Havard E', 'Initials': 'HE', 'LastName': 'Danielsen', 'Affiliation': 'Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kerr', 'Affiliation': 'Oxford Cancer Centre, Churchill Hospital, Oxford University Hospitals Foundation NHS Trust, Oxford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kerr', 'Affiliation': 'Nuffield Division of Clinical Laboratory Sciences, University of Oxford, Oxford, OX3 9 DU, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Tomlinson', 'Affiliation': 'Institute of Cancer and Genomic Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Ragnhild A', 'Initials': 'RA', 'LastName': 'Lothe', 'Affiliation': 'Department of Molecular Oncology, Institute for Cancer Research & K.G. Jebsen Colorectal Cancer Research Centre, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Church', 'Affiliation': 'Cancer Genomics and Immunology Group, The Wellcome Centre for Human Genetics, University of Oxford, Roosevelt Drive, Oxford, OX3 7BN, UK. dchurch@well.ox.ac.uk.'}]",British journal of cancer,['10.1038/s41416-019-0540-4']
1220,32461289,Pneumoperitoneum preconditioning for the prevention of renal function after laparoscopic partial nephrectomy: protocol for a double-blind randomised controlled trial.,"INTRODUCTION


Renal ischaemia reperfusion injury is an inevitable pathophysiology in different clinical situations including laparoscopic partial nephrectomy (LPN), which can obviously decrease the renal function after surgery. Pneumoperitoneum preconditioning (PP) is a promising approach that can yield a protective effect on kidney, which has already been demonstrated in some animal models. The present study is designed to assess whether the PP can yield a clinical renoprotective role after LPN.
METHODS AND ANALYSIS


This study is a randomised, prospective, double-blind and parallel controlled clinical trial. Eligible participants will be patients with renal tumours and willing to choose elective LPN. Patients randomised to the treatment arm will receive PP consisted of three cycles of 5 min insufflation and 5 min desufflation before LPN, while the control arm will receive a sham operation. The primary endpoints are glomerular filtration rate and the level of serum cystatin C within 6 months after desufflation. The secondary endpoints are serum creatinine, estimated glomerular filtration rate, alanine transaminase, serum amylase, intestinal fatty acid binding protein, postoperative hospital stay, the incidence of adverse events and mortality in postoperative 6 months.
ETHICS AND DISSEMINATION


This study has been approved by the institutional ethics committee of Nanjing First Hospital. The results of this study will be reported faithfully through scientific conferences or published articles.
TRIAL REGISTRATION NUMBER


NCT03822338.",2020,"The secondary endpoints are serum creatinine, estimated glomerular filtration rate, alanine transaminase, serum amylase, intestinal fatty acid binding protein, postoperative hospital stay, the incidence of adverse events and mortality in postoperative 6 months.
","['Eligible participants will be patients with renal tumours and willing to choose elective LPN', 'renal function after laparoscopic partial nephrectomy']","['laparoscopic partial nephrectomy (LPN', 'Pneumoperitoneum preconditioning (PP', 'Pneumoperitoneum preconditioning']","['renal function', 'serum creatinine, estimated glomerular filtration rate, alanine transaminase, serum amylase, intestinal fatty acid binding protein, postoperative hospital stay, the incidence of adverse events and mortality in postoperative 6 months', 'glomerular filtration rate and the level of serum cystatin C']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022665', 'cui_str': 'Neoplasm of kidney'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1144661', 'cui_str': 'Laparoscopic partial nephrectomy'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]","[{'cui': 'C1144661', 'cui_str': 'Laparoscopic partial nephrectomy'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0201885', 'cui_str': 'Amylase measurement, serum'}, {'cui': 'C0163314', 'cui_str': 'Intestinal Fatty Acid-Binding Protein'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}]",,0.715931,"The secondary endpoints are serum creatinine, estimated glomerular filtration rate, alanine transaminase, serum amylase, intestinal fatty acid binding protein, postoperative hospital stay, the incidence of adverse events and mortality in postoperative 6 months.
","[{'ForeName': 'Changcheng', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China.'}, {'ForeName': 'Luwei', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China.'}, {'ForeName': 'Yuzheng', 'Initials': 'Y', 'LastName': 'Ge', 'Affiliation': 'Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China.'}, {'ForeName': 'Liuhua', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Nuclear Medicine Center, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China.'}, {'ForeName': 'Jingyu', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China.'}, {'ForeName': 'Gaojian', 'Initials': 'G', 'LastName': 'Pan', 'Affiliation': 'Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China.'}, {'ForeName': 'Tianli', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China.'}, {'ForeName': 'Ruipeng', 'Initials': 'R', 'LastName': 'Jia', 'Affiliation': 'Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China urojiarp@njmu.edu.cn.'}]",BMJ open,['10.1136/bmjopen-2019-032002']
1221,32461297,Lengthening adalimumab dosing interval in quiescent Crohn's disease patients: protocol for the pragmatic randomised non-inferiority LADI study.,"INTRODUCTION


Adalimumab is effective for maintenance of remission in patients with Crohn's disease (CD) at a dose of 40 mg subcutaneously every 2 weeks. However, adalimumab is associated with (long-term) adverse events and is costly. The aim of this study is to demonstrate non-inferiority and cost-effectiveness of disease activity guided adalimumab interval lengthening compared to standard dosing of every other week (EOW).
METHODS AND ANALYSIS


The Lengthening Adalimumab Dosing Interval (LADI) study is a pragmatic, multicentre, open label, randomised controlled non-inferiority trial. Non-inferiority is reached if the difference in cumulative incidence of persistent (>8 weeks) flares does not exceed the non-inferiority margin of 15%. 174 CD patients on adalimumab maintenance therapy in long-term (>9 months) clinical and biochemical remission will be included (C-reactive protein (CRP) <10 mg/L, faecal calprotectin (FC) <150 µg/g, Harvey-Bradshaw Index (HBI) <5). Patients will be randomised 2:1 into the intervention (adalimumab interval lengthening) or control group (adalimumab EOW). The intervention group will lengthen the adalimumab administration interval to every 3 weeks, and after 24 weeks to every 4 weeks. Clinical and biochemical disease activity will be monitored every 12 weeks by physician global assessment, HBI, CRP and FC. In case of disease flare, dosing will be increased. A flare is defined as two of three of the following criteria; FC>250 µg/g, CRP≥10 mg/l, HBI≥5. Secondary outcomes include cumulative incidence of transient flares, adverse events, predictors for successful dose reduction and cost-effectiveness.
ETHICS AND DISSEMINATION


The study is approved by the Medical Ethics Committee Arnhem-Nijmegen, the Netherlands (registration number NL58948.091.16). Results will be published in peer-reviewed journals and presented at international conferences.
TRIAL REGISTRATION NUMBERS


EudraCT registry (2016-003321-42); Clinicaltrials.gov registry (NCT03172377); Dutch trial registry (NTRID6417).",2020,Non-inferiority is reached if the difference in cumulative incidence of persistent (>8 weeks) flares does not exceed the non-inferiority margin of 15%.,"['174\u2009CD patients on', ""quiescent Crohn's disease patients"", ""patients with Crohn's disease (CD""]","['CRP≥10 mg/l, HBI≥5', 'adalimumab', 'intervention (adalimumab interval lengthening) or control group (adalimumab EOW', 'Adalimumab', 'adalimumab interval lengthening', 'adalimumab maintenance therapy', 'Lengthening adalimumab']","['cumulative incidence of transient flares, adverse events, predictors for successful dose reduction and cost-effectiveness']","[{'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0392744', 'cui_str': 'Lengthened'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0441592', 'cui_str': 'Surgical lengthening - action'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.22005,Non-inferiority is reached if the difference in cumulative incidence of persistent (>8 weeks) flares does not exceed the non-inferiority margin of 15%.,"[{'ForeName': 'L J T', 'Initials': 'LJT', 'LastName': 'Smits', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'R W M', 'Initials': 'RWM', 'LastName': 'Pauwels', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Kievit', 'Affiliation': 'Department for Health Evidence, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'de Jong', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'de Vries', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Hoentjen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'van der Woude', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, The Netherlands c.vanderwoude@erasmusmc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-035326']
1222,32461298,Protocol for hypofractionated adaptive radiotherapy to the bladder within a multicentre phase II randomised trial: radiotherapy planning and delivery guidance.,"INTRODUCTION


Patients with muscle invasive bladder cancer (MIBC) who are unfit and unsuitable for standard radical treatment with cystectomy or daily radiotherapy present a large unmet clinical need. Untreated, they suffer high cancer specific mortality and risk significant disease-related local symptoms. Hypofractionated radiotherapy (delivering higher doses in fewer fractions/visits) is a potential treatment solution but could be compromised by the mobile nature of the bladder, resulting in target misses in a significant proportion of fractions. Adaptive 'plan of the day' image-guided radiotherapy delivery may improve the precision and accuracy of treatment. We aim to demonstrate within a randomised multicentre phase II trial feasibility of plan of the day hypofractionated bladder radiotherapy delivery with acceptable rates of toxicity.
METHODS AND ANALYSIS


Patients with T2-T4aN0M0 MIBC receiving 36 Gy in 6-weekly fractions are randomised (1:1) between treatment delivered using a single-standard plan or adaptive radiotherapy using a library of three plans (small, medium and large). A cone beam CT taken prior to each treatment is used to visualise the anatomy and select the most appropriate plan depending on the bladder shape and size. A comprehensive radiotherapy quality assurance programme has been instituted to ensure standardisation of radiotherapy planning and delivery. The primary endpoint is to exclude  > 30% acute grade  > 3 non-genitourinary toxicity at 3 months for adaptive radiotherapy in patients who received  > 1 fraction (p0=0.7, p1=0.9, α=0.05, β=0.2). Secondary endpoints include local disease control, symptom control, late toxicity, overall survival, patient-reported outcomes and proportion of fractions benefiting from adaptive planning. Target recruitment is 62 patients.
ETHICS AND DISSEMINATION


The trial is approved by the London-Surrey Borders Research Ethics Committee (13/LO/1350). The results will be disseminated via peer-reviewed scientific journals, conference presentations and submission to regulatory authorities.
TRIAL REGISTRATION NUMBER


NCT01810757.",2020,"The primary endpoint is to exclude  > 30% acute grade  > 3 non-genitourinary toxicity at 3 months for adaptive radiotherapy in patients who received  > 1 fraction (p0=0.7, p1=0.9, α=0.05, β=0.2).","['Patients with T2-T4aN0M0 MIBC receiving 36\u2009Gy in 6-weekly fractions', 'Patients with muscle invasive bladder cancer (MIBC) who are unfit and unsuitable for', '62 patients']","['adaptive radiotherapy', 'standard radical treatment with cystectomy or daily radiotherapy', 'radiotherapy planning and delivery guidance', 'single-standard plan or adaptive radiotherapy', 'plan of the day hypofractionated bladder radiotherapy', 'hypofractionated adaptive radiotherapy', 'Hypofractionated radiotherapy']","['exclude  > 30% acute grade  > 3 non-genitourinary toxicity', 'local disease control, symptom control, late toxicity, overall survival, patient-reported outcomes and proportion of fractions benefiting from adaptive planning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0010651', 'cui_str': 'Bladder excision'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0454111', 'cui_str': 'Radiotherapy planning'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0852246', 'cui_str': 'Bladder radiotherapies'}]","[{'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0277565', 'cui_str': 'Local disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}]",,0.169588,"The primary endpoint is to exclude  > 30% acute grade  > 3 non-genitourinary toxicity at 3 months for adaptive radiotherapy in patients who received  > 1 fraction (p0=0.7, p1=0.9, α=0.05, β=0.2).","[{'ForeName': 'Shaista', 'Initials': 'S', 'LastName': 'Hafeez', 'Affiliation': 'Radiotherapy and Imaging, The Institute of Cancer Research, London, UK shaista.hafeez@icr.ac.uk.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Patel', 'Affiliation': 'Mount Vernon Hospital, National Radiotherapy Trials Quality Assurance Group, Northwood, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Webster', 'Affiliation': 'Mount Vernon Hospital, National Radiotherapy Trials Quality Assurance Group, Northwood, UK.'}, {'ForeName': 'Karole', 'Initials': 'K', 'LastName': 'Warren-Oseni', 'Affiliation': 'Radiotherapy and Imaging, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Hansen', 'Affiliation': 'Laboratory of Radiation Physics, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'McNair', 'Affiliation': 'Radiotherapy and Imaging, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miles', 'Affiliation': 'Mount Vernon Hospital, National Radiotherapy Trials Quality Assurance Group, Northwood, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Huddart', 'Affiliation': 'Radiotherapy and Imaging, The Institute of Cancer Research, London, UK.'}]",BMJ open,['10.1136/bmjopen-2020-037134']
1223,32473149,Linear Growth between Early and Late Childhood and Cognitive Outcomes at 6-9 Years of Age.,"OBJECTIVES


To assess the extent to which linear growth beyond the early years of life determines later cognitive development.
STUDY DESIGN


We revisited children from New Delhi, India, who had participated in a randomized controlled trial 6 years before and assessed neurodevelopment using standardized and validated psychometric tools (Wechsler Intelligence Scale for Children, 4th edition; Crichton Vocabulary Scales; and Neuropsychological test battery). The associations of change in height for age z scores between early (12-36 months) and late (6-9 years) childhood with cognitive outcomes at 6-9 years of age were explored using linear regression models, after adjustment for appropriate confounders.
RESULTS


Out of the 1000 North Indian children who were enrolled in the original study, 791 consented to participate in this follow-up. Height for age z scores in the first 2 years of life was significantly associated with both the Wechsler Intelligence Scale for Children-Crichton Vocabulary Scales (standardized β coefficient [β], 0.15; 95% CI, 0.08-0.23), and the Neuropsychological test battery-II z-score (β, 0.09; 95% CI, 0.03-0.18) at 6-9 years of age. There were no significant associations between change in height for age z scores between early and later childhood and Wechsler Intelligence Scale for Children-Crichton Vocabulary Scales (β, -0.03; 95% CI, -0.11 to 0.04) or Neuropsychological test battery-II z-scores (β, -0.04; 95% CI, -0.12 to 0.06).
CONCLUSIONS


Linear growth between early and late childhood is not associated with later cognitive outcomes. Our findings support the current practice of investing public health efforts to accelerate linear growth in the first 2-3 years of life.",2020,"There were no significant associations between change in HAZ scores between early and later childhood and WISC-CVS [ẞ -0.03, 95% CI: -0.11 to 0.04] or NEPSY-II z-scores [ẞ -0.04, 95% CI: -0.12 to 0.06].
","['revisited children from New Delhi, India who had participated', '1,000 North Indian children that were enrolled in the original study, 791 consented to participate in this follow-up']",['HAZ'],"['psychometric tools (Wechsler Intelligence Scale for Children 4 th  edition, WISC-IV INDIA ; Crichton Vocabulary Scales, CVS; and Neuropsychological test battery, NEPSY-II', 'HAZ scores', 'Linear Growth between Early and Late Childhood and Cognitive Outcomes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086541', 'cui_str': 'Dry form of cutaneous leishmaniasis'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",[],"[{'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0204457', 'cui_str': 'Wechsler intelligence scale for children'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0451093', 'cui_str': 'Crichton vocabulary scale'}, {'cui': 'C0008509', 'cui_str': 'Sampling of chorionic villus'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C2987126', 'cui_str': 'NEPSY'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0581295,"There were no significant associations between change in HAZ scores between early and later childhood and WISC-CVS [ẞ -0.03, 95% CI: -0.11 to 0.04] or NEPSY-II z-scores [ẞ -0.04, 95% CI: -0.12 to 0.06].
","[{'ForeName': 'Ravi Prakash', 'Initials': 'RP', 'LastName': 'Upadhyay', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, New Delhi, India; Centre for International Health, Bergen, Norway.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hysing', 'Affiliation': 'Department of Psychosocial Science, Faculty of Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Taneja', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, New Delhi, India. Electronic address: sunita.taneja@sas.org.in.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Kvestad', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, West, NORCE Norwegian Research Centre, Bergen, Norway.'}, {'ForeName': 'Nita', 'Initials': 'N', 'LastName': 'Bhandari', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.'}, {'ForeName': 'Tor A', 'Initials': 'TA', 'LastName': 'Strand', 'Affiliation': 'Centre for International Health, Bergen, Norway; Department of Research, Innlandet Hospital Trust, Lillehammer, Norway.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.05.043']
1224,32474130,Randomized controlled trial protocol for project BRIDGE: A telephone-administered motivational interviewing intervention targeting risky sexual behavior in older people living with HIV.,"PURPOSE


By 2020, 70% of people living with HIV in the United States will be greater than 50 years of age. As many as 37% of sexually active older people living with HIV (OPLWH) engage in HIV transmission sexual behaviors. In spite of repeated calls for secondary prevention interventions to reduce condomless sex in OPLWH, no age-appropriate, evidence-based secondary prevention interventions exist for this group. Furthermore, many OPLWH face barriers to engaging in face-to-face secondary prevention services because of HIV- and age-related stigma, comorbid mental and physical health conditions that complicate travel, or geographic isolation. High rates of depression in OPLWH may further complicate engagement in interventions intended to reduce HIV transmissions. Telephone-administered motivational interviewing may be a feasible and efficacious intervention for this population.
METHODS


This randomized controlled trial will test the efficacy of a 5-session telephone-administered motivational interviewing plus behavioral skills training (teleMI+BST) intervention versus a 5-session telephone-administered coping effectiveness training (teleCET) control intervention to reduce condomless sex in OPLWH. A diverse sample of 336 OPLWH will be recruited across the U.S. The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners. Secondary analyses will examine the efficacy of teleMI+BST to reduce depressive symptoms in mildly depressed OPLWH.
CONCLUSION


This is the first large-scale RCT intended to reduce HIV sexual transmission risk behavior in OPLWH and will add to the literature on secondary prevention telehealth interventions for people living with HIV. ClinicalTrials.gov Identifier: NCT03004170. This trial has been conducted by the approval of the Institutional Review Board. Participants provided verbal consent to participate in this trial.",2020,The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners.,"['older people living with HIV', 'people living with HIV', 'A diverse sample of 336 OPLWH will be recruited across the U.S']","['teleMI+BST', 'Telephone-administered motivational interviewing', '5-session telephone-administered motivational interviewing plus behavioral skills training (teleMI+BST) intervention versus a 5-session telephone-administered coping effectiveness training (teleCET) control intervention', 'telephone-administered motivational interviewing intervention']",['depressive symptoms'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",336.0,0.216379,The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners.,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Kahler', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA.'}, {'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Heckman', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Marilyn S', 'Initials': 'MS', 'LastName': 'Huckans', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Feldstein Ewing', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Parsons', 'Affiliation': 'Mindful Designs, 791 Salem Street, Teaneck, NJ 07666, USA.'}, {'ForeName': 'Alissa', 'Initials': 'A', 'LastName': 'Phelps', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sutton', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Holloway', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Travis I', 'Initials': 'TI', 'LastName': 'Lovejoy', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA. Electronic address: lovejoy@ohsu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106047']
1225,32489005,Effectiveness of a self-regulation intervention for weight loss: A randomized controlled trial.,"OBJECTIVES


To evaluate effectiveness and acceptability of a novel intervention, based on self-regulation theory, for weight loss.
DESIGN


A two-arm parallel group design was employed.
METHODS


Adult participants with a BMI ≥ 30 kg/m 2  and the aim to lose weight were recruited and randomized to either a control or intervention group. Both groups were asked to weigh themselves daily for eight weeks. The intervention group was encouraged to use a weight tracking app, and complete daily and weekly questionnaires to prompt action planning, reflection, and evaluation of actions. Participants chose daily actions from a menu of 53 behaviours. The primary outcome was weight change after 8 weeks, assessed using linear mixed effects models. At follow-up, 20 intervention group participants were interviewed regarding their experiences in the trial.
RESULTS


100 participants were recruited, and 98% were followed up at 8 weeks. Mean weight loss was -4.18 kg (SD = 3.84) in the intervention compared to -1.01 kg (SD = 2.67) in the control group; the adjusted difference was -3.20 kg (95% CI -4.49, -1.92). Participants rated the intervention's usefulness as 8.25 (SD = 2.04) on a scale from 1 to 10. Adherence was a significant independent predictor of weight loss success (-1.54 kg per one SD, 95% CI -2.16, -0.93), but not a mediator of the intervention effect. Participants reported that the intervention enabled them to experiment with and identify effective weight loss actions.
CONCLUSIONS


Guiding participants through the self-regulation process was feasible, acceptable to participants, and led to significantly greater short-term weight loss than unguided self-weighing.",2020,"Adherence was a significant independent predictor of weight loss success (-1.54 kg per one SD, 95% CI -2.16, -0.93), but not a mediator of the intervention effect.","['Adult participants with a BMI\xa0≥', '100 participants were recruited, and 98% were followed up at 8\xa0weeks', '30\xa0kg/m 2  and the aim to lose weight']",['self-regulation intervention'],"['weight loss', 'Mean weight loss', 'weight loss success', 'weight change']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",100.0,0.142796,"Adherence was a significant independent predictor of weight loss success (-1.54 kg per one SD, 95% CI -2.16, -0.93), but not a mediator of the intervention effect.","[{'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Frie', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Hartmann-Boyce', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, UK.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, UK.'}]",British journal of health psychology,['10.1111/bjhp.12436']
1226,32484818,The impact of a high-quality basic life support police-based first responder system on outcome after out-of-hospital cardiac arrest.,"BACKGROUND


Laypersons' efforts to initiate basic life support (BLS) in witnessed Out-of-Hospital Cardiac Arrest (OHCA) remain comparably low within western society. Therefore, in order to shorten no-flow times in cardiac arrest, several police-based first responder systems equipped with automated external defibrillators (Pol-AED) were established in urban areas, which subsequently allow early BLS and AED administration by police officers. However, data on the quality of BLS and AED use in such a system and its impact on patient outcome remain scarce and inconclusive.
METHODS


A total of 85 Pol-AED cases were randomly assigned to a gender, age and first rhythm matched non-Pol-AED control group (n = 170) in a 1:2 ratio. Data on quality of BLS were extracted via trans-thoracic impedance tracings of used AED devices.
RESULTS


Comparing Pol-AED cases and the control group, we observed a similar compression rate per minute (p = 0.677) and compression ratio (p = 0.651), mirroring an overall high quality of BLS administered by police officers. Time to the first shock was significantly shorter in Pol-AED cases (6 minutes [IQR: 2-10] vs. 12 minutes [IQR: 8-17]; p<0.001). While Pol-AED was not associated with increased sustained return of spontaneous circulation (p = 0.564), a strong and independent impact on survival until hospital discharge (adj. OR: 1.85 [95%CI: 1.06-3.23; p = 0.030]) and a borderline significance for the association with favorable neurological outcome (adj. OR: 1.58 [95%CI: 0.96-2.89; p = 0.052) were observed.
CONCLUSION


We were able to demonstrate an early start and a high quality of BLS and AED use in Pol-AED assessed OHCA cases. Moreover, the presence of Pol-AED care was associated with better patient survival and borderline significance for favorable neurological outcome.",2020,"While Pol-AED was not associated with increased sustained return of spontaneous circulation (p = 0.564), a strong and independent impact on survival until hospital discharge (adj.",['A total of 85 Pol-AED cases'],['high-quality basic life support police-based first responder system'],"['compression rate per minute', 'quality of BLS', 'survival until hospital discharge', 'compression ratio', 'sustained return of spontaneous circulation']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085098', 'cui_str': 'Police'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3178988', 'cui_str': 'Emergency First Responders'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0085098', 'cui_str': 'Police'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3178988', 'cui_str': 'Emergency First Responders'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}]",170.0,0.0618399,"While Pol-AED was not associated with increased sustained return of spontaneous circulation (p = 0.564), a strong and independent impact on survival until hospital discharge (adj.","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Krammel', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Lobmeyr', 'Affiliation': 'PULS-Austrian Cardiac Arrest Awareness Association, Vienna, Austria.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Sulzgruber', 'Affiliation': 'PULS-Austrian Cardiac Arrest Awareness Association, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Winnisch', 'Affiliation': 'PULS-Austrian Cardiac Arrest Awareness Association, Vienna, Austria.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Weidenauer', 'Affiliation': 'PULS-Austrian Cardiac Arrest Awareness Association, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Poppe', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Datler', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Zeiner', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Keferboeck', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Eichelter', 'Affiliation': 'PULS-Austrian Cardiac Arrest Awareness Association, Vienna, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hamp', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Uray', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schnaubelt', 'Affiliation': 'PULS-Austrian Cardiac Arrest Awareness Association, Vienna, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Nuernberger', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.'}]",PloS one,['10.1371/journal.pone.0233966']
1227,32585338,Targeting T cells in inflammatory bowel disease.,"T cells play a pivotal role in the immune response underlying inflammatory bowel disease (IBD) pathogenesis. On this basis, over the past 25 years several drugs have assessed to target T cells in IBD patients. Amongst anti-CD3 antibodies, visilizumab and foralumab did not show clinical efficacy in ulcerative colitis (UC) and Crohn's disease (CD) patients, respectively, whereas otelixizumab has been tested in vitro only. The anti-CD4 BF-5 and cM-T412, and the anti-CD25 basiliximab and daclizumab were not effective in CD and UC patients, respectively. The anti-NKG2D antibody NNC0142-0002 showed clinical benefit in CD patients, in particular in biologic naïve ones, in a randomized, double-blind, parallel-group, placebo-controlled trial. The anti-CD40L M90 and the GSK1349571A blocking calcium release-activated calcium (CRAC) channels, which are involved in the T cell activation and proliferation, were tested only in ex vivo/in vitro experiments. Apart from ustekinumab, all the other drugs targeting T cell-derived cytokines failed. The reinduction of lamina propria T cell apoptosis is a mechanism to modulate T cell survival exploited by cyclosporin A, azathioprine and anti-tumor necrosis factor-α agents, such as infliximab, adalimumab and golimumab. In this article, we review the drugs targeting T cells via surface receptors, via T cell-derived cytokines, via CRAC channels or by inducing apoptosis.",2020,"Amongst anti-CD3 antibodies, visilizumab and foralumab did not show clinical efficacy in ulcerative colitis (UC) and Crohn's disease (CD) patients, respectively, whereas otelixizumab has been tested in vitro only.","[""ulcerative colitis (UC) and Crohn's disease (CD) patients""]","['cyclosporin A, azathioprine', 'daclizumab', 'placebo']",[],"[{'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0663182', 'cui_str': 'Daclizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0961703,"Amongst anti-CD3 antibodies, visilizumab and foralumab did not show clinical efficacy in ulcerative colitis (UC) and Crohn's disease (CD) patients, respectively, whereas otelixizumab has been tested in vitro only.","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Giuffrida', 'Affiliation': 'First Department of Internal Medicine, San Matteo Hospital Foundation, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Di Sabatino', 'Affiliation': 'First Department of Internal Medicine, San Matteo Hospital Foundation, University of Pavia, Pavia, Italy. Electronic address: a.disabatino@smatteo.pv.it.'}]",Pharmacological research,['10.1016/j.phrs.2020.105040']
1228,32585354,The benefits and costs of changing treatment technique in electroconvulsive therapy due to insufficient improvement of a major depressive episode.,"BACKGROUND


Electroconvulsive therapy (ECT) technique is often changed after insufficient improvement, yet there has been little research on switching strategies.
OBJECTIVE


To document clinical outcome in ECT nonresponders who were received a second course using high dose, brief pulse, bifrontotemporal (HD BP BL) ECT, and compare relapse rates and cognitive effects relative to patients who received only one ECT course and as a function of the type of ECT first received.
METHODS


Patients were classified as receiving Weak, Strong, or HD BP BL ECT during three randomized trials at Columbia University. Nonresponders received HD BP BL ECT. In a separate multi-site trial, Optimization of ECT, patients were randomized to right unilateral or BL ECT and nonresponders also received further treatment with HD BP BL ECT.
RESULTS


Remission rates with a second course of HD BP BL ECT were high in ECT nonresponders, approximately 60% and 40% in the Columbia University and Optimization of ECT studies, respectively. Clinical outcome was independent of the type of ECT first received. A second course with HD BP BL ECT resulted in greater retrograde amnesia immediately, two months, and six months following ECT.
CONCLUSIONS


In the largest samples of ECT nonresponders studied to date, a second course of ECT had marked antidepressant effects. Since the therapeutic effects were independent of the technique first administered, it is possible that many patients may benefit simply from longer courses of ECT. Randomized trials are needed to determine whether, when, and how to change treatment technique in ECT.",2020,Clinical outcome was independent of the type of ECT first received.,"['Patients were classified as receiving Weak, Strong, or HD BP BL ECT during three randomized trials at Columbia University', 'patients who received only one ECT course and as a function of the type of ECT first received']","['Electroconvulsive therapy (ECT) technique', 'right unilateral or BL ECT', 'Electroconvulsive Therapy', 'HD BP BL ECT']","['retrograde amnesia', 'HD BP BL ECT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0002624', 'cui_str': 'Retrograde amnesia'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]",,0.0665526,Clinical outcome was independent of the type of ECT first received.,"[{'ForeName': 'Harold A', 'Initials': 'HA', 'LastName': 'Sackeim', 'Affiliation': 'Department of Psychiatry, Columbia University, NY, USA; Department of Radiology, Columbia University, NY, USA. Electronic address: has1@columbia.edu.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Prudic', 'Affiliation': 'Department of Psychiatry, Columbia University, NY, USA; New York State Psychiatric Institute, NY, USA.'}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Devanand', 'Affiliation': 'Department of Psychiatry, Columbia University, NY, USA; New York State Psychiatric Institute, NY, USA; Department of Neurology, Columbia University, NY, USA.'}, {'ForeName': 'Mitchell S', 'Initials': 'MS', 'LastName': 'Nobler', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, New York Medical College, NY, USA.'}, {'ForeName': 'Roger F', 'Initials': 'RF', 'LastName': 'Haskett', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Rosenquist', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'McCall', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.06.016']
1229,32453168,Dislocation rates of perineural catheters placed either perpendicular or parallel to the femoral nerve: A randomised controlled trial.,"BACKGROUND


Ultrasound has increased the efficacy of femoral nerve catheters but their postoperative dislocation still remains a common problem. Although catheter placement parallel to the nerve seems to reduce dislocation rates in other nerves and plexuses, the possible advantage for femoral nerve catheter placement remains unclear.
OBJECTIVE


To compare the dislocation rates of femoral catheters when placed perpendicular or parallel to the femoral nerve.
DESIGN


Randomised controlled study.
SETTING


University orthopaedic hospital. Duration of study: October 2018 to June 2019.
PATIENTS


Eighty patients scheduled for major knee surgery with femoral catheter were enrolled and randomly allocated in two groups. Data from 78 patients could be analysed.
INTERVENTIONS


The femoral nerve catheters was placed perpendicular to the nerve in Group 1 (n=40), whereas in Group 2 (n=38) parallel to it. For Group 1 the short-axis view of the nerve and an in-plane puncture was used. For Group 2 we used the short-axis view of the nerve and an out-of-plane puncture technique combined with rotation of the transducer to the long-axis view with the needle in-plane.
MAIN OUTCOME MEASURES


Primary outcome was the catheter dislocation rate in the first 48 h. Secondary outcomes were pain scores and sensory blockade.
RESULTS


There was no statistically significant difference between the two techniques regarding dislocation of the catheters at 24 or 48 h (at 48 h, Group 1: 15%, Group 2: 2.6%, P = 0.109). Also pain scores, sensory blockade and rescue doses of ropivacaine did not differ between the groups. However, in Group 2 the technique took longer.
CONCLUSION


Rotating the ultrasound probe to the long-axis in-plane view enabled examination of the catheter position when it was placed parallel to the nerve. The parallel placement of the catheter required more time, but did not significantly improve dislocation rate, pain scores or sensory blockade.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT03693755.",2020,"The parallel placement of the catheter required more time, but did not significantly improve dislocation rate, pain scores or sensory blockade.
","['University orthopaedic hospital', '78 patients could be analysed', 'Eighty patients scheduled for major knee surgery with femoral catheter', 'Duration of study: October 2018 to June 2019']","['perineural catheters placed either perpendicular or parallel to the femoral nerve', 'ropivacaine', 'plane puncture technique combined with rotation of the transducer to the long-axis view with the needle in-plane']","['Dislocation rates', 'dislocation of the catheters', 'pain scores and sensory blockade', 'catheter dislocation rate', 'dislocation rates', 'pain scores, sensory blockade and rescue doses', 'dislocation rate, pain scores or sensory blockade', 'dislocation rates of femoral catheters']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0187769', 'cui_str': 'Operative procedure on knee'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1518982', 'cui_str': 'Perineural route'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C1295725', 'cui_str': 'Perpendicular axis'}, {'cui': 'C0015808', 'cui_str': 'Structure of femoral nerve'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0040661', 'cui_str': 'Transducer'}, {'cui': 'C0522487', 'cui_str': 'Long axis'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]","[{'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]",80.0,0.154648,"The parallel placement of the catheter required more time, but did not significantly improve dislocation rate, pain scores or sensory blockade.
","[{'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Kalimeris', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Rupnik', 'Affiliation': ''}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Allenspach', 'Affiliation': ''}, {'ForeName': 'Sandro F', 'Initials': 'SF', 'LastName': 'Fucentese', 'Affiliation': ''}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Götschi', 'Affiliation': ''}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Aguirre', 'Affiliation': ''}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Eichenberger', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001237']
1230,32450057,Influence of Bleeding Risk on Outcomes of Radial and Femoral Access for Percutaneous Coronary Intervention: An Analysis From the GLOBAL LEADERS Trial.,"BACKGROUND


Radial artery access has been shown to reduce mortality and bleeding events, especially in patients with acute coronary syndromes. Despite this, interventional cardiologists experienced in femoral artery access still prefer that route for percutaneous coronary intervention. Little is known regarding the merits of each vascular access in patients stratified by their risk of bleeding.
METHODS


Patients from the Global Leaders trial were dichotomized into low or high risk of bleeding by the median of the PRECISE-DAPT score. Clinical outcomes were compared at 30 days.
RESULTS


In the overall population, there were no statistical differences between radial and femoral access in the rate of the primary end point, a composite of all-cause mortality, or new Q-wave myocardial infarction (MI) (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.42-1.15). Radial access was associated with a significantly lower rate of the secondary safety end point, Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding (HR 0.55, 95% CI 0.36-0.84). Compared by bleeding risk strata, in the high bleeding score population, the primary (HR 0.47, 95% CI 0.26-0.85; P = 0.012; P interaction  = 0.019) and secondary safety (HR 0.57, 95% CI 0.35-0.95; P = 0.030; P interaction  = 0.631) end points favoured radial access. In the low bleeding score population, however, the differences in the primary and secondary safety end points between radial and femoral artery access were no longer statistically significant.
CONCLUSIONS


Our findings suggest that the outcomes of mortality or new Q-wave MI and BARC 3 or 5 bleeding favour radial access in patients with a high, but not those with a low, risk of bleeding. Because this was not a primary analysis, it should be considered hypothesis generating.",2020,"In the overall population, there were no statistical differences between radial and femoral access in the rate of the primary end point, a composite of all-cause mortality, or new Q-wave myocardial infarction (MI) (hazard ratio [HR]","['Percutaneous Coronary Intervention', 'patients with acute coronary syndromes', 'Patients from the Global Leaders trial were dichotomized into low or high risk of bleeding by the median of the PRECISE-DAPT score']",[],"['radial and femoral artery access', 'secondary safety end point, Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding', 'mortality and bleeding events', 'bleeding risk strata', 'mortality or new Q-wave MI and BARC 3 or 5 bleeding favour radial access', 'secondary safety', 'composite of all-cause mortality, or new Q-wave myocardial infarction (MI) (hazard ratio [HR']","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4039184', 'cui_str': 'High risk of bleeding'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0634829', 'cui_str': '1,2-dilinolenoyl-3-(4-aminobutyryl)propane-1,2,3-triol'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",[],"[{'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0429089', 'cui_str': 'Electrocardiogram Q waves'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.402974,"In the overall population, there were no statistical differences between radial and femoral access in the rate of the primary end point, a composite of all-cause mortality, or new Q-wave myocardial infarction (MI) (hazard ratio [HR]","[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': ""Department of Cardiology. Xijing Hospital, Xi'an, China; Department of Cardiology, Radboud University, Nijmegen, The Netherlands; Department of Cardiology, National University of Ireland, Galway, Ireland.""}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Buszman', 'Affiliation': 'Centre for Cardiovascular Research and Development, American Heart of Poland, Kostkowice, Poland; Andrzej Frycz Modrzewski Krakow University, Krakow, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Buszman', 'Affiliation': 'Centre for Cardiovascular Research and Development, American Heart of Poland, Ustron, Poland.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Cardiology Division. Department of Internal Medicine, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Department of Cardiology, Royal Blackburn Hospital, Blackburn, UK.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands; Department of Cardiology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Rutao', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology. Xijing Hospital, Xi'an, China; Department of Cardiology, Radboud University, Nijmegen, The Netherlands; Department of Cardiology, National University of Ireland, Galway, Ireland.""}, {'ForeName': 'Chun Chin', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Department of Cardiology, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Erasmus Medical Center, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands; Department of Cardiology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands; Department of Cardiology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Ton', 'Initials': 'T', 'LastName': 'Slagboom', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Aminian', 'Affiliation': 'Division of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium.'}, {'ForeName': 'Christoph Kurt', 'Initials': 'CK', 'LastName': 'Naber', 'Affiliation': 'Department of Cardiology and Angiology, Elisabeth-Krankenhaus Essen, Essen, Germany.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Carrie', 'Affiliation': 'Cardiology B Department, CHU Toulouse, Hôpital Rangueil, Toulouse, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Kerckhoff Heart Center, Bad Nauheim, Germany.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': ""Hôpital Bichat, l'Assistance Publique-Hôpitaux de Paris, Université Paris-Diderot, Paris, France; Royal Brompton Hospital, Imperial College, London, United Kingdom.""}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Erasmus Medical Center, Erasmus University, Rotterdam, The Netherlands; Department of Cardiology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Robert-Jan van', 'Initials': 'RV', 'LastName': 'Geuns', 'Affiliation': 'Department of Cardiology, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, United Kingdom; Department of Cardiology, National University of Ireland, Galway, Ireland. Electronic address: patrick.w.j.c.serruys@gmail.com.'}, {'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Zurakowski', 'Affiliation': 'Andrzej Frycz Modrzewski Krakow University, Krakow, Poland; American Heart of Poland, Chrzanow, Poland.'}]",The Canadian journal of cardiology,['10.1016/j.cjca.2020.01.029']
1231,32450102,Prevalence of microvascular and macrovascular disease in the Glycemia Reduction Approaches in Diabetes - A Comparative Effectiveness (GRADE) Study cohort.,"AIMS


The Glycemia Reduction Approaches in Diabetes - A Comparative Effectiveness (GRADE) trial is a randomized clinical trial comparing glycemic effects of four diabetes medications added to metformin in type 2 diabetes (T2D). Microvascular and macrovascular diseases are secondary outcomes. We evaluated the prevalence and risk factor relationships for microvascular and macrovascular complications in the GRADE cohort at study entry.
METHODS


Complication prevalence and risk factors were analyzed based on data from screening in all consenting participants meeting GRADE eligibility. Logistic regression and Z-statistics were used to assess risk factor relationships with complications.
RESULTS


We enrolled 5047 T2D participants [mean age 57 years; 36% female; mean known T2D duration 4 years (all < 10 years); mean HbA1c 8.0% (∼64 mmol/mol) at screening]. Urinary albumin/creatinine ratio (ACR) ≥ 30 mg/gram was present in 15.9% participants; peripheral neuropathy (by Michigan Neuropathy Screening Instrument) in 21.5%; cardiovascular autonomic neuropathy by electrocardiography-derived indices in 9.7%; self-reported retinopathy in 1.0%. Myocardial infarction ascertained by self-report or electrocardiogram was present in 7.3%, and self-reported history of stroke in 2.0%.
CONCLUSIONS


In the GRADE cohort with < 10 years of T2D and a mean HbA1c of 8.0%, diabetes complications were present in a substantial fraction of participants, more so than might otherwise have been expected.",2020,Urinary albumin/creatinine ratio (ACR) ≥30 mg/gram was present in 15.9% participants; peripheral neuropathy (by Michigan Neuropathy Screening Instrument) in 21.5%; cardiovascular autonomic neuropathy by electrocardiography-derived indices in 9.7%; self-reported retinopathy in 1.0%.,"['5047 T2D participants [mean age 57 years; 36% female; mean knownT2D duration 4 years (all<10 years); mean', 'Diabetes ', 'type 2 diabetes (T2D']",['metformin'],"['peripheral neuropathy', 'diabetes complications', 'Myocardial infarction ascertained by self-report or electrocardiogram', 'Urinary albumin/creatinine ratio (ACR) ≥30 mg/gram', 'cardiovascular autonomic neuropathy']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0342257', 'cui_str': 'Diabetic complication'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0259749', 'cui_str': 'Autonomic neuropathy'}]",5047.0,0.0726804,Urinary albumin/creatinine ratio (ACR) ≥30 mg/gram was present in 15.9% participants; peripheral neuropathy (by Michigan Neuropathy Screening Instrument) in 21.5%; cardiovascular autonomic neuropathy by electrocardiography-derived indices in 9.7%; self-reported retinopathy in 1.0%.,"[{'ForeName': 'Kieren J', 'Initials': 'KJ', 'LastName': 'Mather', 'Affiliation': 'Division of Endocrinology & Metabolism, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, United States.'}, {'ForeName': 'Ionut', 'Initials': 'I', 'LastName': 'Bebu', 'Affiliation': 'The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, MD, United States. Electronic address: grademail@bsc.gwu.edu.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Baker', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, Department of Medicine, University of Colorado School of Medicine, Aurora, CO, United States.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Cohen', 'Affiliation': 'Division of Endocrinology, Diabetes & Metabolism, Department of Medicine, University of Cincinnati College of Medicine & Endocrine Section, Cincinnati VA Medical Center, Cincinnati OH, United States.'}, {'ForeName': 'Jill P', 'Initials': 'JP', 'LastName': 'Crandall', 'Affiliation': 'Division of Endocrinology and Fleischer Institute for Diabetes & Metabolism, Albert Einstein College of Medicine, Bronx, NY, United States.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'DeSouza', 'Affiliation': 'Division of Diabetes, Endocrinology & Metabolism, University of Nebraska College of Medicine, Omaha, NE, United States.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Green', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Duke University Medical Center, Durham, NC, United States.'}, {'ForeName': 'M Sue', 'Initials': 'MS', 'LastName': 'Kirkman', 'Affiliation': 'Division of Endocrinology & Metabolism, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, United States.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Krause-Steinrauf', 'Affiliation': 'The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, MD, United States.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Larkin', 'Affiliation': 'Massachusetts General Hospital Diabetes Center and Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Pettus', 'Affiliation': 'Division of Endocrinology & Metabolism, Department of Medicine, University of California, San Diego, CA, United States.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Seaquist', 'Affiliation': 'Division of Diabetes and Endocrinology, Department of Medicine, University of Minnesota Medical School, Minneapolis, MN, United States.'}, {'ForeName': 'Elsayed Z', 'Initials': 'EZ', 'LastName': 'Soliman', 'Affiliation': 'Epidemiological Cardiology Research Center, Department of Epidemiology and Prevention and Department of Internal Medicine-Cardiology Section, Wake Forest School of Medicine, Winston Salem, NC, United States.'}, {'ForeName': 'Emily B', 'Initials': 'EB', 'LastName': 'Schroeder', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, United States.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Wexler', 'Affiliation': 'Massachusetts General Hospital Diabetes Center and Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Pop-Busui', 'Affiliation': 'Division of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108235']
1232,32454841,The Restorative Effect of the Natural Environment on University Students' Psychological Health.,"The present study evaluated the effect of a three-week intervention aimed at improving psychological health in university students. Participants included 200 Australian students randomly assigned to an experimental or waitlist control group, with 42 adhering to intervention instructions. Participants in the experimental group read a story about someone who used the natural environment to decrease stress and burnout levels and to increase their perceived satisfaction with life. They were then instructed to spend 20 minutes each week, for three weeks, in any chosen natural environment. Waitlist control participants received intervention instructions three weeks later. Restorativeness was positively associated with life satisfaction and negatively related to stress and burnout. Experimental participants, compared to waitlist control participants, experienced a significant decrease in stress; however, the intervention had no effect on life satisfaction or burnout. More research is still needed to determine the practical significance of nature exposure on university students' psychological health.",2020,"Experimental participants, compared to waitlist control participants, experienced a significant decrease in stress; however, the intervention had no effect on life satisfaction or burnout.","['university students', 'Participants included 200 Australian students randomly assigned to an', ""University Students' Psychological Health""]","['experimental or waitlist control group, with 42 adhering to intervention instructions', 'Natural Environment']","['psychological health', 'stress', 'life satisfaction']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0557745', 'cui_str': 'Natural environment'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",200.0,0.0230612,"Experimental participants, compared to waitlist control participants, experienced a significant decrease in stress; however, the intervention had no effect on life satisfaction or burnout.","[{'ForeName': 'Emma A', 'Initials': 'EA', 'LastName': 'Payne', 'Affiliation': 'University of New England, Armidale, Australia.'}, {'ForeName': 'Natasha M', 'Initials': 'NM', 'LastName': 'Loi', 'Affiliation': 'University of New England, Armidale, Australia.'}, {'ForeName': 'Einar B', 'Initials': 'EB', 'LastName': 'Thorsteinsson', 'Affiliation': 'University of New England, Armidale, Australia.'}]",Journal of environmental and public health,['10.1155/2020/4210285']
1233,32456442,"Herbal Drug EPs 7630  versus  Amoxicillin in Patients with Uncomplicated Acute Bacterial Rhinosinusitis: A Randomized, Open-Label Study.","OBJECTIVE


Previous investigations suggest the use of extract from the root of  Pelargonium sidoides  (EPs 7630) for the therapy of uncomplicated acute upper airway inflammations, due to its strong antimicrobial and immunomodulatory effect. We aimed to compare clinical efficacy, safety and bactericidal effect of EPs 7630 and amoxicillin monotherapy in treatment of patients with mild to moderate acute bacterial rhinosinusitis (ABRS).
METHODS


Fifty ABRS patients were divided into two groups by randomization. Group 1 (n = 25) received EPs 7630 tablets, 3 × 20 mg/day per os for 10 days. Group 2 (n = 25) received amoxicillin tablets 3 × 500 mg/day per os, for 10 days. We assessed total symptom score (TSS), individual symptom scores for each symptom (nasal obstruction, rhinorrhea, postnasal drip, facial pain/pressure, loss of the sense of smell), endoscopic findings, including total endoscopic score (TES) and individual endoscopic signs (mucosal edema, mucopurulent secretion), before and after treatment. Samples of discharge taken from the middle meatus of all patients were cultivated for bacteria before and after therapy.
RESULTS


Higher absolute improvement after treatment was found for TSS, nasal obstruction, facial pain/pressure, impaired sense of smell, TES, mucosal edema and mucopurulent secretion in EPs 7630 group compared to amoxicillin group ( P  < .001 for all parameters). However, there were no differences in absolute improvement of rhinorrhea score and postnasal drip score between groups ( P  = .248;  P  = .679, respectively). Fewer types of bacteria grew on culture from middle meatal samples in EPs 7630 group compared to amoxicillin group. There were no reported adverse events from patients from either group.
CONCLUSION


Our results demonstrated better clinical and antimicrobial efficacy of EPs 7630 than amoxicillin. EPs 7630 was shown as a potent agent and good alternative to antibiotic treatment of uncomplicated ABRS.",2020,"RESULTS


Higher absolute improvement after treatment was found for TSS, nasal obstruction, facial pain/pressure, impaired sense of smell, TES, mucosal edema and mucopurulent secretion in EPs 7630 group compared to amoxicillin group ( P  < .001 for all parameters).","['Fifty ABRS patients', 'Patients with Uncomplicated Acute Bacterial Rhinosinusitis', 'patients with mild to moderate acute bacterial rhinosinusitis (ABRS']","['amoxicillin', 'EPs 7630 and amoxicillin monotherapy', 'amoxicillin tablets', 'Herbal Drug EPs 7630  versus  Amoxicillin']","['rhinorrhea score and postnasal drip score', 'clinical efficacy, safety and bactericidal effect', 'TSS, nasal obstruction, facial pain/pressure, impaired sense of smell, TES, mucosal edema and mucopurulent secretion', 'adverse events', 'total symptom score (TSS), individual symptom scores for each symptom (nasal obstruction, rhinorrhea, postnasal drip, facial pain/pressure, loss of the sense of smell), endoscopic findings, including total endoscopic score (TES) and individual endoscopic signs (mucosal edema, mucopurulent secretion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C1244600', 'cui_str': 'Amoxicillin Oral Tablet'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032781', 'cui_str': 'Posterior rhinorrhea'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C2364082', 'cui_str': 'Sense of smell impaired'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0521481', 'cui_str': 'Mucous membrane edema'}, {'cui': 'C0443266', 'cui_str': 'Mucopurulent'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003126', 'cui_str': 'Loss of sense of smell'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0220912', 'cui_str': 'signs'}]",50.0,0.0241304,"RESULTS


Higher absolute improvement after treatment was found for TSS, nasal obstruction, facial pain/pressure, impaired sense of smell, TES, mucosal edema and mucopurulent secretion in EPs 7630 group compared to amoxicillin group ( P  < .001 for all parameters).","[{'ForeName': 'Aleksandar', 'Initials': 'A', 'LastName': 'Perić', 'Affiliation': 'Department of Otorhinolaryngology, Military Medical Academy Faculty of Medicine, University of Defence, Belgrade, Serbia.'}, {'ForeName': 'Dejan', 'Initials': 'D', 'LastName': 'Gaćeša', 'Affiliation': 'ENT Hospital ""Dr. Žutić"", Belgrade, Serbia.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Barać', 'Affiliation': 'School of Medicine, University in Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Sotirović', 'Affiliation': 'Department of Otorhinolaryngology, Military Medical Academy Faculty of Medicine, University of Defence, Belgrade, Serbia.'}, {'ForeName': 'Aneta V', 'Initials': 'AV', 'LastName': 'Perić', 'Affiliation': 'Institute for Pharmacy, Military Medical Academy Faculty of Medicine, University of Defence, Belgrade, Serbia.'}]","The Annals of otology, rhinology, and laryngology",['10.1177/0003489420918266']
1234,32458282,EEG Theta/Beta Ratio Neurofeedback Training in Healthy Females.,A growing number of studies suggest that EEG theta/beta ratio (TBR) is inversely related to executive cognitive control. Neurofeedback training aimed at reducing TBR (TBR NFT) might provide a tool to study causality in this relation and might enhance human performance. To investigate whether TBR NFT reduces TBR in healthy participants. Twelve healthy female participants were assigned (single blind) to one of three groups. Groups differed on baseline durations and one group received only sham NFT. TBR NFT consisted of eight or fourteen 25-min sessions. No evidence was found that TBR NFT had any effect on TBR. The current TBR NFT protocol is possibly ineffective. This is in line with a previous study with a different protocol.,2020,No evidence was found that TBR NFT had any effect on TBR.,"['healthy participants', 'Healthy Females', 'Twelve healthy female participants']","['sham NFT', 'Neurofeedback training aimed at reducing TBR (TBR NFT', 'TBR NFT']","['TBR', 'EEG Theta/Beta Ratio Neurofeedback Training', 'EEG theta/beta ratio (TBR']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0085400', 'cui_str': 'Neurofibrillary degeneration'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",12.0,0.0266986,No evidence was found that TBR NFT had any effect on TBR.,"[{'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'van Son', 'Affiliation': 'Institute of Psychology, Leiden University, Leiden, The Netherlands. dana.vanson@yale.edu.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'van der Does', 'Affiliation': 'Institute of Psychology, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Guido P H', 'Initials': 'GPH', 'LastName': 'Band', 'Affiliation': 'Institute of Psychology, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Putman', 'Affiliation': 'Institute of Psychology, Leiden University, Leiden, The Netherlands.'}]",Applied psychophysiology and biofeedback,['10.1007/s10484-020-09472-1']
1235,32463117,K ATP  channels modulate cerebral blood flow and oxygen delivery during isocapnic hypoxia in humans.,"KEY POINTS


ATP-sensitive K +  (K ATP  ) channels mediate hypoxia-induced cerebral vasodilatation and hyperperfusion in animals. We tested whether K ATP  channels blockade affects the increase in human cerebral blood flow (CBF) and the maintenance of oxygen delivery (CDO 2  ) during hypoxia. Hypoxia-induced increases in the anterior circulation and total cerebral perfusion were attenuated under K ATP  channels blockade affecting the relative changes of brain oxygen delivery. Therefore, in humans, K ATP  channels activation modulates the vascular tone in the anterior circulation of the brain, contributing to CBF and CDO 2  responses to hypoxia.
ABSTRACT


ATP-sensitive K +  (K ATP  ) channels mediate hypoxia-induced cerebral vasodilatation and hyperperfusion in animals. We tested whether K ATP  channels blockade affects the increase in cerebral blood flow (CBF) and the maintenance of oxygen delivery (CDO 2  ) during hypoxia in humans. Nine healthy men were exposed to 5-min trials of normoxia and isocapnic hypoxia (IHX, 10% O 2  ) before (BGB) and 3 h after glibenclamide ingestion (AGB). Mean arterial pressure (MAP), arterial saturation (  S   a   O   2        ), partial pressure of oxygen (  P   a   O   2        ) and carbon dioxide (  P   aC   O   2        ), internal carotid artery blood flow (ICABF), vertebral artery blood flow (VABF), total (t)CBF (Doppler ultrasound) and CDO 2  were quantified during the trials. IHX provoked similar reductions in  S   a   O   2        and  P   a   O   2        , while MAP was not affected by oxygen desaturation or K ATP  blockade. A smaller increase in ICABF (ΔBGB: 36 ± 23 vs. ΔAGB 11 ± 18%, p = 0.019) but not in VABF (∆BGB 26 ± 21 vs. ∆AGB 27 ± 27%, p = 0.893) was observed during the hypoxic trial under K ATP  channels blockade. Thus, IHX-induced increases in tCBF (∆BGB 32 ± 19 vs. ∆AGB 14 ± 13%, p = 0.012) and CDO 2  relative changes (∆BGB 7 ± 13 vs. ∆AGB -6 ± 14%, p = 0.048) were attenuated during the AGB hypoxic trial. In a separate protocol, 6 healthy men (5 from protocol 1) underwent a 5-min exposure to normoxia and IHX before and 3 h after placebo (5 mg of cornstarch) ingestion. IHX reduced  S   a   O   2        and  P   a   O   2        , but placebo did not affect the ICABF, VABF, tCBF, or CDO 2  responses. Therefore, in humans, K ATP  channels activation modulates vascular tone in the anterior rather than the posterior circulation of the brain, contributing to tCBF and CDO 2  responses to hypoxia.",2020,"IHX reduced SaO 2  and PaO 2  , but placebo did not affect ICABF, VABF, tCBF, or CDO 2  responses.","['6\xa0healthy men (5 from protocol 1) underwent', 'Nine healthy men', 'humans']","['normoxia and isocapnic hypoxia (IHX, 10% O 2  ) before (BGB) and 3\xa0h after glibenclamide ingestion (AGB', 'IHX', 'KATP channels blockade', '5-min exposure to normoxia and IHX before and 3\xa0h after placebo (5\xa0mg of cornstarch) ingestion', 'KATP channels', 'placebo']","['anterior circulation and total cerebral perfusion', 'ICABF', 'human cerebral blood flow (CBF', 'tCBF', 'Mean arterial pressure (MAP), arterial saturation (SaO 2  ), oxygen (PaO 2  ) and carbon dioxide (PaCO 2  ) partial pressure, internal carotid artery blood flow (ICABF), vertebral artery blood flow (VABF), total (t)CBF (Doppler Ultrasound) and CDO 2', 'cerebral blood flow (CBF', 'cerebral blood flow and oxygen delivery', 'ICABF, VABF, tCBF, or CDO 2  responses']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1955862', 'cui_str': 'ATP-Sensitive Potassium Channels'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1384515', 'cui_str': 'corn starch'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0007276', 'cui_str': 'Internal carotid artery structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0042559', 'cui_str': 'Structure of vertebral artery'}, {'cui': 'C0162481', 'cui_str': 'Doppler ultrasound'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}]",9.0,0.0504265,"IHX reduced SaO 2  and PaO 2  , but placebo did not affect ICABF, VABF, tCBF, or CDO 2  responses.","[{'ForeName': 'Marcos P', 'Initials': 'MP', 'LastName': 'Rocha', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'Monique O', 'Initials': 'MO', 'LastName': 'Campos', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'João D', 'Initials': 'JD', 'LastName': 'Mattos', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Mansur', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'Helena N M', 'Initials': 'HNM', 'LastName': 'Rocha', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'Niels H', 'Initials': 'NH', 'LastName': 'Secher', 'Affiliation': 'Department of Anaesthesia, The Copenhagen Muscle Research Centre, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Antonio C L', 'Initials': 'ACL', 'LastName': 'Nóbrega', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'Igor A', 'Initials': 'IA', 'LastName': 'Fernandes', 'Affiliation': 'NeuroV̇ASQ̇-Integrative Physiology Laboratory, Faculty of Physical Education, University of Brasília, Brazil.'}]",The Journal of physiology,['10.1113/JP279751']
1236,32459635,Promoting Employees' Recovery During Shift Work: Protocol for a Workplace Intervention Study.,"BACKGROUND


Shift work can be demanding owing to disturbances in the biological and social rhythms. This can cause short-term negative effects in employees, such as increased fatigue and reduced alertness. A potential way to counteract these negative effects is to enhance employees' recovery from work during working hours.
OBJECTIVE


The aim of this study is to develop and implement an intervention that focuses on promoting ""on-job"" recovery of shift workers.
METHODS


This study is performed in 2 department units with shift workers at a multinational company in the steel industry. For each department, an intervention will be developed and implemented through an iterative process of user-centered design and evaluation. This approach consists of various sessions in which employees and a project group (ie, researchers, line managers, human resource managers, and occupational health experts) provide input on the intervention content and implementation. Intervention effects will be evaluated using pretest and posttest web-based surveys. Digital ecological momentary assessment will be performed to gain insight into the link between the intervention and daily within-person processes. The intervention process and participants' perception of the interventions will be assessed through a process evaluation. Intervention results will be analyzed by performing mixed model repeated measures analyses and multilevel analyses.
RESULTS


This study is supported by the Netherlands Organization for Applied Scientific Research Work and Health Research Program, which is funded by the Ministry of Economic Affairs and supported by the Dutch Ministry of Social Affairs and Employment, program number 19.204.1-3. This study was approved by the institutional review board on February 7, 2019. From June to August 2019, baseline data were collected, and from November to December 2019, the first follow-up data were collected. The second follow-up data collection and data analysis are planned for the first two quarters of 2020. Dissemination of the results is planned for the last two quarters of 2020.
CONCLUSIONS


A strength of this study design is the participatory action approach to enhance the stakeholder commitments, intervention adherence, and compliance. Moreover, since the target group will be participating in the development and implementation of the intervention, the proposed impact will be high. In addition, the short-term as well as the long-term effects will be evaluated. Finally, this study uses a unique combination of quantitative and qualitative evaluation methods. A limitation of this study is that it is impossible to randomly assign participants to an intervention or control group. Furthermore, the follow-up period (6 months) might be too short to establish health-related effects. Lastly, the results of this study might be specific to the department, organization, or sector, which limits the generalizability of the findings. However, as workplace intervention research for shift workers is scarce, this study might serve as a starting point for future research on shift work interventions.",2020,"For each of two departmental units of shift workers, an intervention will be developed and implemented through an iterative process of user-centered design and evaluation.",[],['Digital Ecological Momentary Assessment (EMA'],[],[],"[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}]",[],,0.0487991,"For each of two departmental units of shift workers, an intervention will be developed and implemented through an iterative process of user-centered design and evaluation.","[{'ForeName': 'Irene Mw', 'Initials': 'IM', 'LastName': 'Niks', 'Affiliation': 'The Netherlands Organization for Applied Scientific Research (TNO), Leiden, Netherlands.'}, {'ForeName': 'Alwin', 'Initials': 'A', 'LastName': 'van Drongelen', 'Affiliation': 'The Netherlands Organization for Applied Scientific Research (TNO), Leiden, Netherlands.'}, {'ForeName': 'Elsbeth M', 'Initials': 'EM', 'LastName': 'de Korte', 'Affiliation': 'The Netherlands Organization for Applied Scientific Research (TNO), Leiden, Netherlands.'}]",JMIR research protocols,['10.2196/17368']
1237,32459670,"Effects of combining manual lymphatic drainage and Kinesiotaping on pain, edema, and range of motion in patients with total knee replacement: a randomized clinical trial.","Total knee replacement (TKR) is continuously increasing with significantly faster recovery times. Soft tissue pain and edema of operated limbs play an important role in early functional recovery. The present study aims to evaluate the effectiveness of the combination of Kinesiotaping and Lymphatic drainage for the containment of pain and edema as well as the improvement of the range of motion of the knee as integration with standard postoperative rehabilitation. Ninety-nine TKR patients were included in the randomized clinical trial and divided into three groups: Kinesiotaping and Lymphatic drainage Group, Lymphatic drainage Group, and Kinesiotaping Group. The assessment was carried out on days 2-4-6 postoperation. All the patients had also standard reeducation sessions. It was observed that both Kinesiotaping and Lymphatic drainage was useful in reducing pain and edema. A significantly higher improvement was observed in the group in which Lymphatic drainage was associated with Kinesiotaping with respect to the individual treatments, for pain and leg circumference over and under the knee, and at the ankle. Range of motion of the knee did not show any difference since the flexion degree was similar in all the three groups. No difference was found between Kinesiotaping and Lymphatic drainage. In conclusion, the treatment with a combination Kinesiotaping and Lymphatic drainage provided better results on pain and edema observed as early as the first days after the intervention, thus may be considered a valid support for standard rehabilitation and pharmacological intervention.",2020,Range of motion of the knee did not show any difference since the flexion degree was similar in all the three groups.,"['Ninety-nine TKR patients', 'patients with total knee replacement']","['manual lymphatic drainage and Kinesiotaping', 'Kinesiotaping and Lymphatic drainage', 'Kinesiotaping and Lymphatic drainage Group, Lymphatic drainage Group, and Kinesiotaping Group', 'Total knee replacement (TKR']","['Kinesiotaping and Lymphatic drainage', 'pain, edema, and range of motion', 'flexion degree', 'pain and edema', 'pain and leg circumference']","[{'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0556834', 'cui_str': 'Manual lymphatic drainage'}, {'cui': 'C0398480', 'cui_str': 'Drainage of lymphatics'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0398480', 'cui_str': 'Drainage of lymphatics'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}]",99.0,0.031628,Range of motion of the knee did not show any difference since the flexion degree was similar in all the three groups.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Tornatore', 'Affiliation': 'Physical Medicine and Rehabilitation Unit, IRCCS-Istituto Ortopedico Rizzoli, Bagheria.'}, {'ForeName': 'Maria Laura', 'Initials': 'ML', 'LastName': 'De Luca', 'Affiliation': 'Physical Medicine and Rehabilitation Unit, IRCCS-Istituto Ortopedico Rizzoli, Bagheria.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Ciccarello', 'Affiliation': 'Anesthesia-Resuscitation and Intensive care Unit, Rizzoli Sicilia Department, Bagheria, Palermo, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Benedetti', 'Affiliation': 'Physical Medicine and Rehabilitation Unit, IRCCS-Istituto Ortopedico Rizzoli, Bagheria.'}]",International journal of rehabilitation research. Internationale Zeitschrift fur Rehabilitationsforschung. Revue internationale de recherches de readaptation,['10.1097/MRR.0000000000000417']
1238,32460459,Effectiveness of nivolumab versus regorafenib in hepatocellular carcinoma patients who failed sorafenib treatment.,"BACKGROUND/AIMS


Several treatment options are currently available for patients with hepatocellular carcinoma (HCC) failing previous sorafenib treatment. We aimed to compare the effectiveness of regorafenib and nivolumab in these patients.
METHODS


Consecutive HCC patients who received regorafenib or nivolumab after failure of sorafenib treatment were included. Primary endpoint was overall survival (OS) and secondary endpoints were time to progression, tumor response rate, and adverse events. Inverse probability of treatment weighting (IPTW) using the propensity score was conducted to reduce treatment selection bias.
RESULTS


Among 150 study patients, 102 patients received regorafenib and 48 patients received nivolumab. Median OS was 6.9 (95% confidence interval [CI], 3.0-10.8) months for regorafenib and 5.9 (95% CI, 3.7-8.1) months for nivolumab (P=0.77 by log-rank test). In multivariable analysis, nivolumab was associated with prolonged OS (vs. regorafenib: adjusted hazard ratio [aHR], 0.54; 95% CI, 0.30-0.96; P=0.04). Time to progression was not significantly different between groups (nivolumab vs. regorafenib: aHR, 0.82; 95% CI, 0.51-1.30; P=0.48). HRs were maintained after IPTW. Objective response rates were 5.9% and 16.7% in patients treated with regorafenib and nivolumab, respectively (P=0.04).
CONCLUSION


After sorafenib failure, the use of nivolumab may be associated with improved OS and better objective response rate as compared to using regorafenib.",2020,"In multivariable analysis, nivolumab was associated with prolonged OS (vs. regorafenib: adjusted hazard ratio [aHR], 0.54; 95% CI, 0.30-0.96; P=0.04).","['150 study patients', 'Consecutive HCC patients who received regorafenib or nivolumab after failure of sorafenib treatment were included', 'patients with hepatocellular carcinoma (HCC) failing previous sorafenib treatment', '102 patients received', 'hepatocellular carcinoma patients who failed sorafenib treatment']","['nivolumab versus regorafenib', 'regorafenib', 'nivolumab', 'regorafenib and nivolumab']","['overall survival (OS) and secondary endpoints were time to progression, tumor response rate, and adverse events', 'Median OS', 'Objective response rates', 'Time to progression', 'OS and better objective response rate']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205156', 'cui_str': 'Previous'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",150.0,0.318331,"In multivariable analysis, nivolumab was associated with prolonged OS (vs. regorafenib: adjusted hazard ratio [aHR], 0.54; 95% CI, 0.30-0.96; P=0.04).","[{'ForeName': 'Cheol-Hyung', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yun Bin', 'Initials': 'YB', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Minseok Albert', 'Initials': 'MA', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Heejoon', 'Initials': 'H', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyunwoo', 'Initials': 'H', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sun Woong', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Eun Ju', 'Initials': 'EJ', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyung-Hun', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Jeong-Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Su Jong', 'Initials': 'SJ', 'LastName': 'Yu', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jung-Hwan', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Tae-You', 'Initials': 'TY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Yoon Jun', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}]",Clinical and molecular hepatology,['10.3350/cmh.2019.0049n']
1239,32460460,Entecavir+tenofovir vs. lamivudine/telbivudine+adefovir in chronic hepatitis B patients with prior suboptimal response.,"BACKGROUND/AIMS


Suboptimal responses to lamivudine or telbivudine plus adefovir (LAM/LdT+ADV) rescue therapy are common in patients with LAM-resistant hepatitis B virus (HBV) infections. We compared patients switched to entecavir plus tenofovir (ETV+TDF) to those maintained on LAM/LdT+ADV.
METHODS


This prospective randomized controlled trial examined 91 patients whose serum HBV DNA levels were greater than 60 IU/mL after at least 24 weeks of treatment with LAM/LdT+ADV for LAM-resistant HBV. Patients were randomized to receive a new treatment (ETV+TDF, n=45) or maintained on the same treatment (LAM/LdT+ADV, n=46) for 48 weeks. Patients with baseline ADV resistance were excluded.
RESULTS


Compared to LAM/LdT+ADV group, ETV+TDF group had more patients with a virologic response (42/45 [93.33%] vs. 3/46 [6.52%], P<0.001) and had a greater mean reduction in serum HBV DNA level from baseline (-4.16 vs. -0.37 log10 IU/mL, P<0.001). Multivariate analysis indicated that high baseline HBV DNA level (P=0.005) and LAM/LdT+ADV maintenance therapy (P=0.001) were negatively associated with virologic response. At week 48, additional ADV- or ETV-associated mutations were cleared in ETV+TDF group, but such mutations were present in 4.3% of patients in LAM/LdT+ADV group (P=0.106). The two groups had similar rates of adverse events.
CONCLUSION


ETV+TDF combination treatment led to a significantly higher rate of virologic response compared to LAM/LdT+ADV combination treatment in patients with LAM-resistant HBV who had suboptimal responses to LAM/LdT+ADV regardless of HBV genotypic resistance profile (NCT01597934).",2020,Multivariate analysis indicated that high baseline HBV DNA level (P=0.005) and LAM/LdT+ADV maintenance therapy (P=0.001) were negatively associated with virologic response.,"['patients with LAM-resistant hepatitis B virus (HBV) infections', '91 patients whose', 'chronic hepatitis B patients with prior suboptimal response', 'Patients with baseline ADV resistance were excluded']","['lamivudine or telbivudine plus adefovir (LAM/LdT+ADV', 'Entecavir+tenofovir vs. lamivudine/telbivudine+adefovir', 'LAM/LdT+ADV', 'entecavir plus tenofovir (ETV+TDF', 'ETV+TDF', 'new treatment (ETV+TDF, n=45) or maintained on the same treatment (LAM/LdT+ADV']","['rate of virologic response', 'high baseline HBV DNA level', 'rates of adverse events', 'virologic response', 'serum HBV DNA level', 'serum HBV DNA levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0065041', 'cui_str': 'lipoarabinomannan'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C1453933', 'cui_str': 'telbivudine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0050175', 'cui_str': 'adefovir'}, {'cui': 'C0065041', 'cui_str': 'lipoarabinomannan'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0369332', 'cui_str': 'Hepatitis B virus DNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0019378', 'cui_str': 'Cercopithecine herpesvirus 1'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}]",91.0,0.051612,Multivariate analysis indicated that high baseline HBV DNA level (P=0.005) and LAM/LdT+ADV maintenance therapy (P=0.001) were negatively associated with virologic response.,"[{'ForeName': 'Hyun Young', 'Initials': 'HY', 'LastName': 'Woo', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Pusan National University, Busan, Korea.'}, {'ForeName': 'Jun Yong', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Si Hyun', 'Initials': 'SH', 'LastName': 'Bae', 'Affiliation': 'Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Chang Wook', 'Initials': 'CW', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Jae Young', 'Initials': 'JY', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine, Institute for Digestive Research, Digestive Disease Center, Soonchunhyang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Won Young', 'Initials': 'WY', 'LastName': 'Tak', 'Affiliation': 'Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Dong Joon', 'Initials': 'DJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.'}, {'ForeName': 'In Hee', 'Initials': 'IH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Chonbuk National University Hospital, Chonbuk National University College of Medicine, Chonju, Korea.'}, {'ForeName': 'Jeong', 'Initials': 'J', 'LastName': 'Heo', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Pusan National University, Busan, Korea.'}, {'ForeName': 'Sang Hoon', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}]",Clinical and molecular hepatology,['10.3350/cmh.2019.0044n']
1240,32467054,Severe perioperative morbidity after robot-assisted versus conventional laparoscopy in gynecologic oncology: Results of the randomized ROBOGYN-1004 trial.,"OBJECTIVE


In gynecologic oncology, minimally invasive surgery using conventional laparoscopy (CL) decreases the incidence of severe morbidity compared to open surgery. In 2005, robot-assisted laparoscopy (RL) was approved for use in gynecology in the US. This study aimed to assess whether RL is superior to CL in terms of morbidity incidence.
METHODS


ROBOGYN-1004 (ClinicalTrials.gov, NCT01247779) was a multicenter, phase III, superiority randomized trial that compared RL and CL in patients with gynecologic cancer requiring minimally invasive surgery. Patients were recruited between 2010 and 2015. The primary endpoint was incidence of severe perioperative morbidity (severe complications during or 6 months after surgery).
RESULTS


Overall, 369 of 385 patients were included in the as-treated analysis: 176 and 193 underwent RL and CL, respectively. The median operating time for RL was 190 (range, 75-432) minutes and for CL was 145 (33-407) minutes (p < 0.001). The blood loss volumes for the corresponding procedures were 100 (0-2500) and 50 (0-1000) mL (p = 0.003), respectively. The overall rates of conversion to open surgery for the corresponding procedures were 7% (10/176) and 5% (10/193), respectively (p = 0.52). Severe perioperative morbidity occurred in 28% (49/176) and 21% (41/192) of patients who underwent RL and CL, respectively (p = 0.15). At a median follow-up of 25.1 months (range, 0.6-78.2), no significant differences in overall and disease-free survival were observed between the groups.
CONCLUSIONS


RL was not found superior to CL with regard to the incidence of severe perioperative morbidity in patients with gynecologic cancer. In addition, RL involved a longer operating time than CL.",2020,"CONCLUSIONS


RL was not found superior to CL with regard to the incidence of severe perioperative morbidity in patients with gynecologic cancer.","['Patients were recruited between 2010 and 2015', 'patients with gynecologic cancer requiring minimally invasive surgery', 'gynecologic oncology', 'patients with gynecologic cancer', '369 of 385 patients were included in the as-treated analysis']","['conventional laparoscopy (CL', 'RL and CL', 'robot-assisted laparoscopy (RL', 'robot-assisted versus conventional laparoscopy', 'RL']","['Severe perioperative morbidity', 'median operating time for RL', 'severe perioperative morbidity (severe complications', 'overall and disease-free survival', 'severe perioperative morbidity', 'severe morbidity', 'overall rates of conversion to open surgery', 'blood loss volumes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}, {'cui': 'C4517751', 'cui_str': '385'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C3494226', 'cui_str': 'Conversion to an Open Procedure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",385.0,0.185524,"CONCLUSIONS


RL was not found superior to CL with regard to the incidence of severe perioperative morbidity in patients with gynecologic cancer.","[{'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Narducci', 'Affiliation': 'Oscar Lambret Cancer Center, Lille, France. Electronic address: f-narducci@o-lambret.fr.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Bogart', 'Affiliation': 'Oscar Lambret Cancer Center, Lille, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hebert', 'Affiliation': 'Tours University Hospital, Tours, France.'}, {'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Gauthier', 'Affiliation': 'Limoges University Hospital, Limoges, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Collinet', 'Affiliation': 'Lille University Hospital, Lille, France.'}, {'ForeName': 'Jean Marc', 'Initials': 'JM', 'LastName': 'Classe', 'Affiliation': ""Institut de Cancérologie de l'Ouest, Nantes, France.""}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Lecuru', 'Affiliation': 'Georges-Pompidou University Hospital, Paris, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Delest', 'Affiliation': 'Polyclinique Bordeaux Nord Aquitaine, Bordeaux, France.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Motton', 'Affiliation': 'Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Conri', 'Affiliation': 'Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ferrer', 'Affiliation': 'Nimes University Hospital, Nimes, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Marchal', 'Affiliation': 'CRAN, UMR 7039, Université de Lorraine, CNRS Institut de Cancérologie de Lorraine Vandoeuvre-les-Nancy, France.'}, {'ForeName': 'Gwenael', 'Initials': 'G', 'LastName': 'Ferron', 'Affiliation': 'Institut Claudius Regaud Cancer Center, Toulouse, France.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Probst', 'Affiliation': 'Oscar Lambret Cancer Center, Lille, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Thery', 'Affiliation': 'Oscar Lambret Cancer Center, Lille, France.'}, {'ForeName': 'Marie-Cécile', 'Initials': 'MC', 'LastName': 'Le Deley', 'Affiliation': 'Oscar Lambret Cancer Center, Lille, France; Université Paris-Saclay, Université Paris-Sud, UVSQ, CESP, INSERM, Villejuif, France.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Lefebvre', 'Affiliation': 'Oscar Lambret Cancer Center, Lille, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Francon', 'Affiliation': 'Institut Paoli Calmettes Cancer Center, Marseille, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Leblanc', 'Affiliation': 'Oscar Lambret Cancer Center, Lille, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lambaudie', 'Affiliation': 'Institut Paoli Calmettes Cancer Center, Marseille, France.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.05.010']
1241,32470863,The effect of Korean Red Ginseng on sarcopenia biomarkers in type 2 diabetes patients.,"BACKGROUND


The elderly population is growing rapidly worldwide and sarcopenia, which is considered as a new geriatric syndrome has become an important issue. In particular, diabetes is known to be an important risk factor for sarcopenia. In this study, we investigated the effects of Korean Red Ginseng (KRG) on biomarkers of sarcopenia in middle and old age diabetes patients.
PATIENTS AND METHODS


This study was a randomized, double-blind, placebo-controlled trial. Participants were randomly allocated to either the placebo or KRG group and took corresponding tablets for 24 weeks. The primary outcomes were changes in sarcopenia biomarkers at week 24. Secondary outcomes were changes in inflammatory and antioxidant markers and lean body mass at week 24.
RESULTS


Fifty-nine patients completed the study. Follistatin and sex hormone binding globulin (SHBG) were significantly improved in KRG group. In the subgroup analysis, female postmenopausal patients over the age of 55 showed a significant improvement in serum SHBG, follistatin, and growth differentiation factor 15 (GDF-15) and an attenuated reduction in Troponin T (TNT) after the administration of KRG.
CONCLUSION


Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women. A further, larger population study with a longer follow-up period is warranted to verify and understand the effects of KRG on sarcopenia.",2020,"Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women.","['type 2 diabetes patients', 'Fifty-nine patients completed the study', 'middle and old age diabetes patients', 'old postmenopausal women']","['placebo or KRG', 'Korean Red Ginseng (KRG', 'KRG', 'Korean Red Ginseng', 'placebo']","['serum SHBG, follistatin, and growth differentiation factor 15 (GDF-15) and an attenuated reduction in Troponin T (TNT', 'sarcopenia biomarkers', 'changes in inflammatory and antioxidant markers and lean body mass', 'changes in sarcopenia biomarkers', 'follistatin and SHBG levels', 'Follistatin and sex hormone binding globulin (SHBG']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0873137', 'cui_str': 'Korean ginseng preparation'}]","[{'cui': 'C0455307', 'cui_str': 'Serum sex hormone binding globulin measurement'}, {'cui': 'C0060623', 'cui_str': 'Activin-Binding Protein'}, {'cui': 'C0668195', 'cui_str': 'Macrophage Inhibitory Cytokine 1'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}]",59.0,0.135337,"Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women.","[{'ForeName': 'Kahui', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea.'}, {'ForeName': 'Chul Woo', 'Initials': 'CW', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea; Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea.'}, {'ForeName': 'YuSik', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea. Electronic address: cromoton@yuhs.ac.'}, {'ForeName': 'Ji Sun', 'Initials': 'JS', 'LastName': 'Nam', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea; Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea. Electronic address: jisunn@yuhs.ac.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104108']
1242,32473365,Central nervous system activities of extract Mangifera indica L.,"ETHNOBOTANICAL RELEVANCE


Leaves of Mangifera indica L. have folk-uses in tropical regions of the world as health teas, as a remedy for exhaustion and fatigue, as a vegetable, and as a medicine. Mangifera indica leaf extract (MLE) had previously been demonstrated to alter brain electrical activity in-vivo. The aim of the present series of studies was to investigate whether mangiferin, a major compound in leaves and in MLE, is responsible for the neurocognitive activity of MLE, and if the CNS activities of MLE have translational potential.
MATERIALS AND METHODS


MLE, tradename Zynamite, is produced by Nektium Pharma, Spain. Isolated mangiferin was tested in-vitro in radioligand binding and enzyme inhibition studies against 106 CNS targets. Changes in the electroencephalograms (EEG's) of MLE and mangiferin were recorded in-vivo from four brain regions. Two double blind randomized placebo-controlled crossover clinical trials were conducted, each with 16 subjects. At 90 min and at 60 min respectively, after oral intake of 500 mg MLE, EEG recordings, psychometric tests, mood state, and tolerability were studied.
RESULTS


Isolated mangiferin is a selective inhibitor of catechol-O-methyltransferase (COMT) with an IC50 of 1.1 μM, with no activity on the CNS targets of caffeine. Both mangiferin and MLE induce similar changes in long-term potentiation (LTP) in the hippocampus in-vitro, and induce a similar pattern of EEG changes in-vivo. In both translational clinical trials MLE was well tolerated, with no cardiovascular side-effects. In both studies MLE caused significant spectral changes in brain electrical activity in cortical regions during cognitive challenges, different to the attenuated spectral changes induced by caffeine. There were no significant changes in the psychometric tests other than reaction time for all groups. In the second study there was a trend to faster reaction time within group for MLE (p = 0.066) and the percentage improvement in reaction time for MLE compared to placebo was significant (p = 0.049). In the first study MLE improved all scores for Profile of Mood States (POMS), with the score for ""fatigue"" significantly improved (p = 0.015); in the second study the POMS score for ""dejection"" was improved in the caffeine group, p = 0.05.
CONCLUSIONS


Mangiferin is a COMT inhibitor of moderate potency and is the major CNS-active compound in MLE. Both mangiferin and MLE increase hippocampal LTP in-vitro, and induce a similar pattern of changes in brain electrical activity in-vivo. While the translational clinical trials of MLE are limited by being single dose studies in a small number of subjects, they provide the first clinical evidence that the extract is well tolerated with no cardiovascular side-effects, can induce changes in brain electrical activity, may give a faster reaction time, and decrease fatigue. These CNS activities support the reported folk-uses use of mango leaf tea as a substitute for tea and as a traditional remedy for fatigue and exhaustion. Extract Mangifera indica L., Zynamite, has nootropic potential, and larger clinical studies are needed to realise this potential.",2020,"Both mangiferin and MLE induce similar changes in long term potentiation (LTP) in the hippocampus in-vitro, and induce a similar pattern of EEG changes in-vivo.",['16 subjects'],"['Mangifera indica leaf extract (MLE', 'caffeine', 'mangiferin and MLE', 'MLE', 'extract Mangifera indica L', 'placebo']","['fatigue', 'POMS score for ""dejection', 'Profile of Mood States (POMS', 'brain electrical activity', 'psychometric tests, mood state, and tolerability', 'reaction time for MLE', 'faster reaction time']",[],"[{'cui': 'C4081111', 'cui_str': 'mango leaf extract'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0065654', 'cui_str': 'mangiferin'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0330955', 'cui_str': 'Mangifera indica'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234388', 'cui_str': 'Electrical activity of brain'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C4081111', 'cui_str': 'mango leaf extract'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",,0.0364453,"Both mangiferin and MLE induce similar changes in long term potentiation (LTP) in the hippocampus in-vitro, and induce a similar pattern of EEG changes in-vivo.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'López-Ríos', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain. Electronic address: llopez@nektium.com.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Wiebe', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain. Electronic address: jwiebe@nektium.com.'}, {'ForeName': 'Tanausú', 'Initials': 'T', 'LastName': 'Vega-Morales', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain. Electronic address: tvega@nektium.com.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Gericke', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain; Department of Botany and Plant Biotechnology, University of Johannesburg, Auckland Park, 2006, Johannesburg, South Africa. Electronic address: ngericke@nektium.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.112996']
1243,32473403,Testing a self-directed lifestyle intervention among veterans: The D-ELITE pragmatic clinical trial.,"Nearly half of Veterans have obesity, fueling chronic diseases. The Department of Veterans Affairs (VA) offers an evidence-based behavioral weight management intervention called MOVE!, mostly delivered through in-person group sessions. Few eligible Veterans participate due to factors like distance and preferences, mirroring barriers in the general population. Practical alternatives to standard in-person programs are needed to improve access and engagement. A self-directed lifestyle intervention called D-ELITE-delivered through pre-recorded videos by DVD or online streaming-previously efficacious in a general primary care population, may provide such an alternative. This pragmatic clinical trial will evaluate whether D-ELITE improves weight and general health status among Veterans with obesity, relative to VA usual care. The yearlong intervention includes one orientation by phone, supplemental lifestyle coaching primarily via technology-based messages, 12 DVD or online streaming sessions over 3 months, and continued self-directed weight management for months 4-12. Participants use MyFitnessPal.com or paper booklets for self-monitoring weight, diet, and physical activity. Follow-up assessments at 12 and 24 months are administered by mail or phone. The study hypothesis is that compared with usual care, D-ELITE will lead to greater improvements in 12-month weight loss, per VA electronic health records, and general physical health status, assessed using the self-reported SF-12 physical composite score. We will also explore D-ELITE's effects on secondary biometric (e.g., HbA1c) and intermediate (e.g., diet) outcomes, reach, and budget impact. If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.",2020,"If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.","['veterans', 'Veterans with obesity, relative to VA usual care']","['supplemental lifestyle coaching primarily via technology-based messages, 12 DVD or online streaming sessions', 'self-directed lifestyle intervention', 'self-directed lifestyle intervention called D-ELITE-delivered through pre-recorded videos by DVD or online streaming-previously efficacious']","['secondary biometric (e.g., HbA1c) and intermediate (e.g., diet) outcomes, reach, and budget impact', 'weight and general health status']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.02449,"If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.","[{'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'Hoerster', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; VA Puget Sound Healthcare System, Seattle Division, Mental Health Service, 1660 South Columbian Way (S-116), Seattle, WA 98108, United States; University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45(th) Street, Suite 300, Seattle, WA 98105, United States. Electronic address: Katherine.Hoerster@va.gov.'}, {'ForeName': 'Margaret P', 'Initials': 'MP', 'LastName': 'Collins', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Margaret.Collins@va.gov.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Au', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; University of Washington, Department of Medicine, 1959 NE Pacific St, Seattle, WA 98195, United States. Electronic address: David.Au@va.gov.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Lane', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Amber.Lane2@va.gov.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Epler', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Eric.Epler@va.gov.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McDowell', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Jennifer.McDowell@va.gov.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Barón', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13001 E. 17(th) Place, Aurora, CO 80045, United States. Electronic address: Anna.Baron@cuanschutz.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rise', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Peter.Rise@va.gov.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Plumley', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Robert.Plumley@va.gov.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Tanya.Nguyen@va.gov.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Schooler', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Mary.Schooler@va.gov.'}, {'ForeName': 'Linnaea', 'Initials': 'L', 'LastName': 'Schuttner', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; University of Washington, Department of Medicine, 1959 NE Pacific St, Seattle, WA 98195, United States. Electronic address: Linnaea.Schuttner@va.gov.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'University of Illinois at Chicago, Department of Medicine, 1747 W. Roosevelt Rd, Room 586 (MC 275), Chicago, IL 60608, United States. Electronic address: maj2015@uic.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106045']
1244,32589506,"Treatment with Volanesorsen, a 2'-O-Methoxyethyl-Modified Antisense Oligonucleotide Targeting  APOC3  mRNA, Does Not Affect the QTc Interval in Healthy Volunteers.","The aim of this study was to assess the effect of volanesorsen on the corrected QT (QTc) interval. This thorough QT study enrolled 52 healthy male and female subjects who were randomized at a single site in a four-way crossover study. Subjects were randomly assigned to 1 of 12 treatment sequences and crossed over into four treatment periods over the course of which each subject was to receive a single therapeutic dose of volanesorsen as a 300 mg subcutaneous (SC) injection, a single supratherapeutic dose of volanesorsen as 300 mg intravenous (IV) infusion, a single oral (PO) dose of moxifloxacin (positive control), and placebo dose. The study demonstrated that volanesorsen 300 mg SC and 300 mg IV did not have a clinically relevant effect on ΔΔQTcF exceeding 10 ms. The largest mean effect at any postdose time point was 3.0 ms (90% confidence interval [CI]: 0.8-5.2) after SC dosing and 1.8 ms (90% CI -0.4 to 4.0) after IV dosing. Volanesorsen, at the studied therapeutic and supratherapeutic doses, does not have a clinically meaningful effect on the QTc.",2020,"Volanesorsen, at the studied therapeutic and supratherapeutic doses, does not have a clinically meaningful effect on the QTc.","['Healthy Volunteers', '52 healthy male and female subjects']","['volanesorsen as a 300\u2009mg subcutaneous (SC) injection, a single supratherapeutic dose of volanesorsen as 300\u2009mg intravenous (IV) infusion, a single oral (PO) dose of moxifloxacin (positive control), and placebo', 'volanesorsen 300\u2009mg SC', 'volanesorsen']","['Corrected QT Interval', 'corrected QT (QTc) interval', 'ΔΔQTcF']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4726970', 'cui_str': 'Volanesorsen'}, {'cui': 'C0100700', 'cui_str': 'A 300'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]",52.0,0.214881,"Volanesorsen, at the studied therapeutic and supratherapeutic doses, does not have a clinically meaningful effect on the QTc.","[{'ForeName': 'Lynnetta M', 'Initials': 'LM', 'LastName': 'Watts', 'Affiliation': 'Clinical Development, Ionis Pharmaceutical, Inc, Carlsbad, California, USA.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Karwatowska-Prokopczuk', 'Affiliation': 'Clinical Development, Akcea Therapeutic, Boston, Massachusetts, USA.'}, {'ForeName': 'Eunju', 'Initials': 'E', 'LastName': 'Hurh', 'Affiliation': 'Clinical Development, Akcea Therapeutic, Boston, Massachusetts, USA.'}, {'ForeName': 'Veronica J', 'Initials': 'VJ', 'LastName': 'Alexander', 'Affiliation': 'Clinical Development, Ionis Pharmaceutical, Inc, Carlsbad, California, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Balogh', 'Affiliation': 'Clinical Development, Ionis Pharmaceutical, Inc, Carlsbad, California, USA.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': ""O'Dea"", 'Affiliation': 'Clinical Development, Akcea Therapeutic, Boston, Massachusetts, USA.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Geary', 'Affiliation': 'Clinical Development, Ionis Pharmaceutical, Inc, Carlsbad, California, USA.'}, {'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Tsimikas', 'Affiliation': 'Clinical Development, Ionis Pharmaceutical, Inc, Carlsbad, California, USA.'}]",Nucleic acid therapeutics,['10.1089/nat.2019.0837']
1245,32590001,"A Randomized Trial of Parenteral Nutrition Using a Mixed Lipid Emulsion Containing Fish Oil in Infants of Extremely Low Birth Weight: Neurodevelopmental Outcome at 12 and 24 Months Corrected Age, A Secondary Outcome Analysis.","OBJECTIVE


To examine whether parenteral nutrition using a mixed lipid emulsion containing fish oil improves the neurodevelopmental outcomes of extremely low birth weight infants.
STUDY DESIGN


The study is a secondary outcome analysis of a double-blind randomized trial of 230 extremely low birth weight infants performed at a single level IV neonatal care unit (Medical University Vienna; June 2012 to June 2015). Participants received either a mixed lipid emulsion composed of soybean oil, medium chain triglycerides, olive oil, and fish oil, or a soybean oil-based lipid emulsion for parenteral nutrition. Neurodevelopment of study participants was assessed at 12 and 24 months corrected age (August 2013 to October 2017) using the Bayley Scales of Infant-Toddler Development, third edition.
RESULTS


At discharge, 206 of the 230 study participants were eligible. At 12 and 24 months corrected age, 174 of 206 (85%) and 164 of 206 (80%) infants were evaluated. At 12 months, there was no significant difference in cognitive (mixed lipid: median, 95 [IQR, 85-101]; soybean oil: median, 95 [IQR, 85-100]; P = .71), language (mixed lipid: median, 86 [IQR, 77-94], soybean oil: median, 89 [IQR, 79-94]; P = .48), or motor scores (mixed lipid: median, 88 [IQR, 76-94], soybean oil: median, 88 [IQR, 79-94]; P = .69). At 24 months, there was again no significant difference in cognitive (mixed lipid: median, 95 [IQR, 80-105], soybean oil: median, 95 [IQR, 90-105]; P = .17), language (mixed lipid: median, 89 [IQR, 75-97], soybean oil 89 [IQR, 77-100]; P = .54), and motor scores (mixed lipid: median, 94 [IQR, 82-103], soybean oil: median, 94 [IQR, 85-103]; P = .53).
CONCLUSIONS


Parenteral nutrition using a mixed lipid emulsion containing fish oil did not improve neurodevelopment of extremely low birth weight infants at 12 and 24 months corrected age.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT01585935.",2020,Parenteral nutrition using a mixed lipid emulsion containing fish oil did not improve neurodevelopment of ELBW infants at 12 and 24 months corrected age.,"['230 ELBW infants performed at a single level IV neonatal care unit (Medical University Vienna; 06/2012-06/2015', 'infants of extremely low birth weight', 'extremely low birth weight (ELBW) infants', 'Neurodevelopment of study participants was assessed at 12 and 24 months corrected age (08/2013-10/2017) using the Bayley Scales of Infant-Toddler Development, Third edition']","['mixed lipid emulsion composed of soybean oil, medium chain triglycerides, olive oil, and fish oil, or a soybean oil-based lipid emulsion', 'parenteral nutrition', 'mixed lipid emulsion containing fish oil']",[],"[{'cui': 'C0456065', 'cui_str': 'Extremely low birth weight infant'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0441796', 'cui_str': 'Third edition'}]","[{'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0037732', 'cui_str': 'Soybean Oil'}, {'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]",[],230.0,0.224401,Parenteral nutrition using a mixed lipid emulsion containing fish oil did not improve neurodevelopment of ELBW infants at 12 and 24 months corrected age.,"[{'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Thanhaeuser', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Fuiko', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Oberleitner-Leeb', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Brandstaetter', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Binder', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Thajer', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Huber-Dangl', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Haiden', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Eleonore', 'Initials': 'E', 'LastName': 'Pablik', 'Affiliation': 'Section for Medical Statistics, CeMSIIS, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Berger', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Repa', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Vienna, Austria. Electronic address: andreas.repa@meduniwien.ac.at.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.06.056']
1246,32590658,Feasibility of Surgeon-Delivered Audit and Feedback Incorporating Peer Surgical Coaching to Reduce Fistula Incidence following Cleft Palate Repair: A Pilot Trial.,"BACKGROUND


Improving surgeons' technical performance may reduce their frequency of postoperative complications. The authors conducted a pilot trial to evaluate the feasibility of a surgeon-delivered audit and feedback intervention incorporating peer surgical coaching on technical performance among surgeons performing cleft palate repair, in advance of a future effectiveness trial.
METHODS


A nonrandomized, two-arm, unblinded pilot trial enrolled surgeons performing cleft palate repair. Participants completed a baseline audit of fistula incidence. Participants with a fistula incidence above the median were allocated to an intensive feedback intervention that included selecting a peer surgical coach, observing the coach perform palate repair, reviewing operative video of their own surgical technique with the coach, and proposing and implementing changes in their technique. All others were allocated to simple feedback (receiving audit results). Outcomes assessed were proportion of surgeons completing the baseline audit, disclosing their fistula incidence to peers, and completing the feedback intervention.
RESULTS


Seven surgeons enrolled in the trial. All seven completed the baseline audit and disclosed their fistula incidence to other participants. The median baseline fistula incidence was 0.4 percent (range, 0 to 10.5 percent). Two surgeons were unable to receive the feedback intervention. Of the five remaining surgeons, two were allocated to intensive feedback and three to simple feedback. All surgeons completed their assigned feedback intervention. Among surgeons receiving intensive feedback, fistula incidence was 5.9 percent at baseline and 0.0 percent following feedback (adjusted OR, 0.98; 95 percent CI, 0.44 to 2.17).
CONCLUSION


Surgeon-delivered audit and feedback incorporating peer coaching on technical performance was feasible for surgeons.",2020,"Participants with a fistula incidence above the median were allocated to an intensive feedback intervention that included selecting a peer surgical coach, observing the coach perform palate repair, reviewing operative video of their own surgical technique with the coach, and proposing and implementing changes in their technique.","['Participants with a fistula incidence above the median', 'Cleft Palate Repair', 'Seven surgeons enrolled in the trial', 'surgeons performing cleft palate repair']","['Surgeon-delivered audit and feedback incorporating peer coaching', 'intensive feedback intervention that included selecting a peer surgical coach, observing the coach perform palate repair, reviewing operative video of their own surgical technique with the coach, and proposing and implementing changes in their technique', 'Surgeon-Delivered Audit and Feedback Incorporating Peer Surgical Coaching', 'surgeon-delivered audit and feedback intervention incorporating peer surgical coaching', 'cleft palate repair']","['median baseline fistula incidence', 'proportion of surgeons completing the baseline audit, disclosing their fistula incidence to peers, and completing the feedback intervention', 'Fistula Incidence', 'fistula incidence']","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0192086', 'cui_str': 'Repair of cleft palate'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0337358', 'cui_str': 'Repair of palate'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0192086', 'cui_str': 'Repair of cleft palate'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",2.0,0.216518,"Participants with a fistula incidence above the median were allocated to an intensive feedback intervention that included selecting a peer surgical coach, observing the coach perform palate repair, reviewing operative video of their own surgical technique with the coach, and proposing and implementing changes in their technique.","[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Sitzman', 'Affiliation': ""Phoenix and Scottsdale, Ariz.; Seattle, Wash.; Durham, N.C.; Toronto and London, Ontario, Canada; Hershey, Pa.; and Akron and Cincinnati, Ohio From the Division of Plastic Surgery, Phoenix Children's Hospital; the Department of Surgery, Mayo Clinic College of Medicine; the Americleft Task Force Surgeon Subgroup; the Divisions of Craniofacial and Plastic Surgery and Plastic Surgery, Department of Surgery, Seattle Children's Hospital; the Division of Plastic, Maxillofacial & Oral Surgery, Duke University Hospital & Children's Health Center; the Cleft Lip and Palate Program, Division of Plastic Surgery, The Hospital for Sick Children; the Department of Surgery, University of Toronto; the Departments of Surgery, Pediatrics, and Neurosurgery, Penn State Hershey Medical Center; the Barrow Cleft and Craniofacial Center; the Division of Plastic and Reconstructive Surgery, Division of Paediatric Surgery, and the Department of Paediatrics, University of Western Ontario; Akron Children's Hospital; and the James M. Anderson Center for Health Systems Excellence, Cincinnati Children's Hospital Medical Center, and the University of Cincinnati College of Medicine.""}, {'ForeName': 'Raymond W', 'Initials': 'RW', 'LastName': 'Tse', 'Affiliation': ''}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Allori', 'Affiliation': ''}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Fisher', 'Affiliation': ''}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Samson', 'Affiliation': ''}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Beals', 'Affiliation': ''}, {'ForeName': 'Damir B', 'Initials': 'DB', 'LastName': 'Matic', 'Affiliation': ''}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Marcus', 'Affiliation': ''}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Grossoehme', 'Affiliation': ''}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Britto', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006907']
1247,32591370,A multicenter phase II randomized trial of durvalumab (MEDI-4736) versus physician's choice chemotherapy in recurrent ovarian clear cell adenocarcinoma (MOCCA).,"BACKGROUND


The optimal treatment of recurrent ovarian clear cell carcinoma remains unknown. There is increasing rationale to support the role of immune checkpoint inhibitors targeting the programmed cell death protein 1 (PD - 1)/programmed death-ligand 1 (PD-L1) axis in ovarian clear cell carcinoma.
PRIMARY OBJECTIVE


To evaluate the efficacy of durvalumab (MEDI-4736) compared with standard chemotherapy in patients with recurrent ovarian clear cell carcinoma.
STUDY HYPOTHESIS


Patients with recurrent ovarian clear cell carcinoma treated with durvalumab will have improved progression-free survival compared with those treated with chemotherapy of physician's choice.
TRIAL DESIGN


The MOCCA study is a multicenter, open-label, randomized phase II trial in patients with recurrent ovarian clear cell carcinoma, which recruited from eight sites across Gynecologic Cancer Group Singapore (GCGS), Korean Gynecologic-Oncology Group (KGOG), and Australia New Zealand Gynecological Oncology Group (ANZGOG). Enrolled patients were randomized in a 2:1 ratio to receive durvalumab or physician's choice of chemotherapy until disease progression, intolerable toxicity, or withdrawal of patient consent.
MAJOR INCLUSION/EXCLUSION CRITERIA


Eligible patients required histologically documented diagnosis of recurrent ovarian clear cell carcinoma, as evidenced by WT1 negativity. All patients must have been of Eastern Cooperative Oncology Group (ECOG) performance status 2 or better, and have had previous treatment with, and progressed or recurred after prior platinum-based chemotherapy. No more than four prior lines of treatment were allowed and prior immune checkpoint inhibitor treatment was not permitted.
PRIMARY ENDPOINTS


The primary endpoint was the median progression-free survival following treatment with durvalumab, compared with physician's choice of chemotherapy. Progression-free survival was defined as the time from the first day of treatment to the first observation of disease progression, or death due to any cause, or last follow-up.
SAMPLE SIZE


The target sample size was 46 patients.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS


Accrual has been completed and results are expected to be presented by mid-2021.
TRIAL REGISTRATION


Clinicaltrials.gov: NCT03405454.",2020,"The primary endpoint was the median progression-free survival following treatment with durvalumab, compared with physician's choice of chemotherapy.","['recurrent ovarian clear cell adenocarcinoma (MOCCA', 'patients with recurrent ovarian clear cell carcinoma', '46 patients', 'All patients must have been of Eastern Cooperative Oncology Group (ECOG) performance status 2 or better, and have had previous treatment with, and progressed or recurred after prior platinum-based chemotherapy', 'Patients with recurrent ovarian clear cell carcinoma treated with', 'patients with recurrent ovarian clear cell carcinoma, which recruited from eight sites across Gynecologic Cancer Group Singapore (GCGS), Korean Gynecologic-Oncology Group (KGOG), and Australia New Zealand Gynecological Oncology Group (ANZGOG']","['standard chemotherapy', ""durvalumab or physician's choice of chemotherapy until disease progression, intolerable toxicity, or withdrawal of patient consent"", 'durvalumab', 'durvalumab (MEDI-4736', ""physician's choice chemotherapy""]","['progression-free survival', 'Progression-free survival', 'median progression-free survival']","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1518693', 'cui_str': 'Clear cell adenocarcinoma of ovary'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3544205', 'cui_str': 'Ovarian clear cell carcinoma'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C3641122', 'cui_str': 'MEDI4736'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",46.0,0.0700606,"The primary endpoint was the median progression-free survival following treatment with durvalumab, compared with physician's choice of chemotherapy.","[{'ForeName': 'Natalie Yl', 'Initials': 'NY', 'LastName': 'Ngoi', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, Singapore.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Heong', 'Affiliation': 'Department of Medical Oncology, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Ow', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, Singapore.'}, {'ForeName': 'Wen Yee', 'Initials': 'WY', 'LastName': 'Chay', 'Affiliation': 'Division of Medical Oncology, National Cancer Centre Singapore, Singapore.'}, {'ForeName': 'Hee Seung', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Chel Hun', 'Initials': 'CH', 'LastName': 'Choi', 'Affiliation': 'Department of Obstetrics and Gynecology, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Goss', 'Affiliation': 'Box Hill Hospital, Box Hill, Victoria, Australia.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Goh', 'Affiliation': ""Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.""}, {'ForeName': 'Bee Choo', 'Initials': 'BC', 'LastName': 'Tai', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Diana Gz', 'Initials': 'DG', 'LastName': 'Lim', 'Affiliation': 'Department of Pathology, National University Hospital, Singapore.'}, {'ForeName': 'Nivashini', 'Initials': 'N', 'LastName': 'Kaliaperumal', 'Affiliation': 'Institute of Molecular and Cell Biology, Agency for Science, Technology and Research, Singapore.'}, {'ForeName': 'Veonice B', 'Initials': 'VB', 'LastName': 'Au', 'Affiliation': 'Institute of Molecular and Cell Biology, Agency for Science, Technology and Research, Singapore.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Connolly', 'Affiliation': 'Institute of Molecular and Cell Biology, Agency for Science, Technology and Research, Singapore.'}, {'ForeName': 'Jae-Weon', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Friedlander', 'Affiliation': 'The Prince of Wales Hospital, Randwick, New South Wales, Australia.'}, {'ForeName': 'Kidong', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Bundang Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'David Sp', 'Initials': 'DS', 'LastName': 'Tan', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, Singapore david_sp_tan@nuhs.edu.sg.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001604']
1248,32592995,Proactive Integrated Consultation-Liaison Psychiatry: A new service model for the psychiatric care of general hospital inpatients.,"OBJECTIVE


To describe a new service model for the psychiatric care of general hospital inpatients, called Proactive Integrated Consultation-Liaison Psychiatry ('Proactive Integrated Psychological Medicine' in the UK).
METHOD


The new service model was developed especially for general hospital inpatient populations with multimorbidity, such as older medical inpatients. Its design was informed by the published literature and the clinical experience of C-L psychiatrists. It was operationalized by a process of iterative piloting.
RESULTS


The rationale for the new model and the principles underpinning it are outlined. Details of how to implement it, including a service manual and associated workbook, are provided. The training of clinicians to deliver it is described. The effectiveness and cost-effectiveness of this new service model is being evaluated. Whilst we have found it feasible to deliver and well-accepted by ward teams, potential challenges to its wider implementation are discussed.
CONCLUSION


Proactive Integrated Consultation-Liaison Psychiatry (PICLP) is a fusion of proactive consultation and integrated care, operationalized in a field-tested service manual. Initial experience indicates that it is feasible to deliver. Its effectiveness and cost effectiveness for older patients on acute medical wards is currently being evaluated in a large multicentre randomized controlled trial (The HOME Study).",2020,"The new service model was developed especially for general hospital inpatient populations with multimorbidity, such as older medical inpatients.","['general hospital inpatient populations with multimorbidity, such as older medical inpatients', ""general hospital inpatients, called Proactive Integrated Consultation-Liaison Psychiatry ('Proactive Integrated Psychological Medicine' in the UK"", 'general hospital inpatients', 'older patients on acute medical wards']","['Proactive Integrated Consultation-Liaison Psychiatry (PICLP', 'Proactive Integrated Consultation-Liaison Psychiatry']",['effectiveness and cost-effectiveness'],"[{'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0145088,"The new service model was developed especially for general hospital inpatient populations with multimorbidity, such as older medical inpatients.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sharpe', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK. Electronic address: michael.sharpe@psych.ox.ac.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Toynbee', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2020.06.005']
1249,32593791,Differential effects of modafinil on performance of low-performing and high-performing individuals during total sleep deprivation.,"BACKGROUND


Individual responses to the effects of inadequate sleep have been well documented; some people are more vulnerable to the effects of sleep loss than others. Fatigue-vulnerable individuals generally require access to effective fatigue countermeasures; however, the question arises as to whether these fatigue-vulnerable individuals receive the same benefits shown in group efficacy data. The present study administered modafinil to individuals to determine its differential effects on performance of best and worst performers during sleep deprivation.
METHODS


A sample of 22 men, age 21-40 yrs., was tested on 2 separate occasions during which they were kept awake for 36 h. During one period they received 200 mg modafinil; during the other they received placebo. Participants were tested on a variety of tasks while rested and at 5-hr intervals across the continuous wakefulness period. Performance for each cognitive task and subjective measure of fatigue from the placebo period was used to group individuals into high (HP) or low performance (LP) groups to indicate fatigue vulnerability for each task.
RESULTS


Results indicated that on the MTS task, the HP group performed the same throughout the testing period, regardless of whether they received modafinil or not. However, the LP group significantly improved after receiving modafinil compared to placebo. Performance on the PVT showed the HP group had a small decrease in the number of lapses after receiving modafinil compared to placebo, whereas the LP group had a large decrease in lapses after receiving modafinil compared to placebo. Performance on the RDM showed no difference between groups, regardless of drug condition. Groups did not differ after receiving modafinil on subjective fatigue measured by the POMS.
CONCLUSIONS


Depending on the task, HP individuals did not benefit substantially when administered modafinil compared to placebo. However, the LP individuals improved after receiving modafinil compared to placebo.",2020,"Performance on the PVT showed the HP group had a small decrease in the number of lapses after receiving modafinil compared to placebo, whereas the LP group had a large decrease in lapses after receiving modafinil compared to placebo.","['low-performing and high-performing individuals during total sleep deprivation', 'group individuals into high (HP) or low performance (LP) groups to indicate fatigue vulnerability for each task', 'A sample of 22 men, age 21-40\u202fyrs., was tested on 2 separate occasions during which they were kept awake for 36\u202fh']","['modafinil', '200\u202fmg modafinil', 'placebo']","['subjective fatigue', 'lapses', 'number of lapses']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0521125', 'cui_str': 'For'}]","[{'cui': 'C0066677', 'cui_str': 'modafinil'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.090569,"Performance on the PVT showed the HP group had a small decrease in the number of lapses after receiving modafinil compared to placebo, whereas the LP group had a large decrease in lapses after receiving modafinil compared to placebo.","[{'ForeName': 'J Lynn', 'Initials': 'JL', 'LastName': 'Caldwell', 'Affiliation': 'Naval Medical Research Unit Dayton, United States of America. Electronic address: jo.caldwell@us.af.mil.'}, {'ForeName': 'Valarie M', 'Initials': 'VM', 'LastName': 'Schroeder', 'Affiliation': 'The Henry M. Jackson Foundation for the Advancement of Military Medicine, United States of America.'}, {'ForeName': 'Christina L', 'Initials': 'CL', 'LastName': 'Kunkle', 'Affiliation': 'The Henry M. Jackson Foundation for the Advancement of Military Medicine, United States of America.'}, {'ForeName': 'Henry G', 'Initials': 'HG', 'LastName': 'Stephenson', 'Affiliation': 'The Henry M. Jackson Foundation for the Advancement of Military Medicine, United States of America.'}]","Pharmacology, biochemistry, and behavior",['10.1016/j.pbb.2020.172968']
1250,32460997,An international randomized phase III trial of pulse actinomycin-D versus multi-day methotrexate for the treatment of low risk gestational trophoblastic neoplasia; NRG/GOG 275.,"OBJECTIVES


Methotrexate and actinomycin-D are both effective first-line drugs for low-risk (WHO score 0-6) Gestational Trophoblastic Neoplasia (GTN) with considerable debate about which is more effective, less toxic, and better tolerated. The primary trial objective was to test if treatment with multi-day methotrexate (MTX) was inferior to pulse actinomycin-D (ACT-D). Secondary objectives included evaluation of severity and frequency of adverse events, and impact on quality of life (QOL).
METHODS


This was a prospective international cooperative group randomized phase III two arm non-inferiority study (Clinical Trials Identifier: (NCT01535053). The control arm was ACT-D; the experimental arm was multi-day MTX regimen (institutional preference of 5 or 8 day). Outcome measures included complete response rate, recurrence rate, toxicity, and QOL as measured by FACT-G and FACIT supplemental items.
RESULTS


The complete response rates for multi-day methotrexate and pulse actinomycin-D were 88% (23/26 patients) and 79% (22/28 patients) (p = NS) respectively, there were two recurrences in each arm, and 100% of patients survived. Significant toxicity was minimal, but mouth sores (mucositis), and eye pain were significantly more common in the MTX arm (p = 0.001 and 0.01 respectively). Quality of life showed no significant difference in overall quality of life, body image, sexual function, or treatment related side effects. The study was closed for low accrual rate (target 384, actual accrual 57), precluding statistical analysis of the primary objective.
CONCLUSIONS


The complete response rate for multi-day methotrexate was higher than actinomycin-D, but did not reach statistical significance. The multi-day MTX regimens were associated with significantly more mucositis and were significantly less convenient.",2020,"The complete response rate for multi-day methotrexate was higher than actinomycin-D, but did not reach statistical significance.",['low risk gestational trophoblastic neoplasia; NRG/GOG 275'],"['pulse actinomycin-D (ACT-D', 'pulse actinomycin-D versus multi-day methotrexate', 'MTX', 'multi-day methotrexate (MTX', 'Methotrexate and actinomycin-D']","['complete response rates', 'mouth sores (mucositis), and eye pain', 'mucositis', 'evaluation of severity and frequency of adverse events, and impact on quality of life (QOL', 'Significant toxicity', 'overall quality of life, body image, sexual function, or treatment related side effects', 'complete response rate, recurrence rate, toxicity, and QOL as measured by FACT-G and FACIT supplemental items', 'complete response rate']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C1135868', 'cui_str': 'Gestational trophoblastic neoplasia'}, {'cui': 'C4517676', 'cui_str': '275'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0010934', 'cui_str': 'Dactinomycin'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0149745', 'cui_str': 'Ulcer of mouth'}, {'cui': 'C0151827', 'cui_str': 'Pain in eye'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.121683,"The complete response rate for multi-day methotrexate was higher than actinomycin-D, but did not reach statistical significance.","[{'ForeName': 'Julian C', 'Initials': 'JC', 'LastName': 'Schink', 'Affiliation': 'Cancer Treatment Centers of America, Comprehensive Care and Research Center, Chicago, IL, USA. Electronic address: Julian.schink@CTCA-hope.com.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Filiaci', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA. Electronic address: FiliaciV@NRGOncology.org.'}, {'ForeName': 'Helen Q', 'Initials': 'HQ', 'LastName': 'Huang', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA. Electronic address: HuangH@NRGOncology.org.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Tidy', 'Affiliation': 'Sheffield Teaching Hospitals, NHS Trust, Royal Hallamshire Hospital, Glossop Rd, Sheffield S10 2JF, UK. Electronic address: John.Tidy@sth.nhs.uk.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Winter', 'Affiliation': 'Sheffield Teaching Hospitals, NHS Trust, Royal Hallamshire Hospital, Glossop Rd, Sheffield S10 2JF, UK. Electronic address: matthew.winter@sth.nhs.uk.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Carter', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, 641 Lexington Avenue, New York, NY, USA. Electronic address: carterj@mskcc.org.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Anderson', 'Affiliation': 'Northwestern University, Chicago, IL, USA. Electronic address: naanders@nm.org.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Moxley', 'Affiliation': 'Oklahoma University Health Science Center, Oklahoma City, OK, USA. Electronic address: Katherine-Moxley@ouhsc.edu.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Yabuno', 'Affiliation': 'Saitama Medical University International Medical Center, Saitama, Japan. Electronic address: yabunoakira@yahoo.co.jp.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Taylor', 'Affiliation': 'Gynecologic Oncology, Magee-Womens Hospital of University of Pittsburgh Medical Center, Pittsburgh, PA, USA. Electronic address: taylorse@upmc.edu.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kushnir', 'Affiliation': ""Gynecologic Oncology, Women's Cancer Center of Nevada, Las Vegas, NV, USA. Electronic address: ckushnir@wccenter.com.""}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Horowitz', 'Affiliation': 'Harvard Medical School, Massachusetts General Hospital, Boston, MA, USA. Electronic address: nhorowitz@partners.org.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Miller', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA. Electronic address: david.miller@utsouthwestern.edu.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.05.013']
1251,32466446,Multicomponent Exercise Program Reduces Frailty and Inflammatory Biomarkers and Improves Physical Performance in Community-Dwelling Older Adults: A Randomized Controlled Trial.,"The efficacy of exercise to reverse frailty in the aging population has not been extensively investigated. This study aimed to investigate the effectiveness of a multicomponent exercise program (MCEP) on frailty, physical performance (handgrip strength, Berg Balance Scale (BBS), Timed Up and Go test (TUG), and VO 2 Max), blood biomarkers (Interleukin-6 (IL-6) and C-reactive protein (CRP)) in frail older adults. A randomized controlled trial using an allocation concealment method, included 64 older adults (77.78 ± 7.24 years), were divided into two parallel groups using block randomization: an MCEP group ( n  = 32) and a control group ( n  = 32). The combined center- and home-based MCEP training consisted of chair aerobic, resistance, and balance, which was carried out 3 days per week for 24 weeks. A mixed model repeated measure ANOVA demonstrated significant interaction effects of group x time for BBS, TUG and frailty scores ( p  < 0.001). Additionally, the post-hoc analysis revealed that the MCEP group showed significantly improved BBS, TUG, and frailty scores ( p  < 0.01), at both 12- and 24-weeks. When compared with controls at 12-weeks, the MCEP group decreased IL-6 and CRP levels ( p  < 0.05). The combined center- and home-based MCEP were effective in reversing frailty to pre-frailty and improving physical performance especially balance in the older population.",2020,"A mixed model repeated measure ANOVA demonstrated significant interaction effects of group x time for BBS, TUG and frailty scores ( p  < 0.001).","['frail older adults', 'Community-Dwelling Older Adults', '64 older adults (77.78 ± 7.24 years']","['Multicomponent Exercise Program', 'multicomponent exercise program (MCEP', 'MCEP', 'combined center- and home-based MCEP']","['BBS, TUG and frailty scores', 'Frailty and Inflammatory Biomarkers and Improves Physical Performance', 'frailty, physical performance (handgrip strength, Berg Balance Scale (BBS), Timed Up and Go test (TUG), and VO 2 Max), blood biomarkers (Interleukin-6 (IL-6) and C-reactive protein (CRP', 'BBS, TUG, and frailty scores', 'IL-6 and CRP levels']","[{'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",64.0,0.0358322,"A mixed model repeated measure ANOVA demonstrated significant interaction effects of group x time for BBS, TUG and frailty scores ( p  < 0.001).","[{'ForeName': 'Uratcha', 'Initials': 'U', 'LastName': 'Sadjapong', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Supachai', 'Initials': 'S', 'LastName': 'Yodkeeree', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Somporn', 'Initials': 'S', 'LastName': 'Sungkarat', 'Affiliation': 'Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Penprapa', 'Initials': 'P', 'LastName': 'Siviroj', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}]",International journal of environmental research and public health,['10.3390/ijerph17113760']
1252,32466496,Dance Fitness Classes Improve the Health-Related Quality of Life in Sedentary Women.,"This study aims to analyze the effect of two dance-focused and choreographic fitness classes on Health-Related Quality of Life (HRQoL) in sedentary worker women.  Methods :  65 sedentary middle-aged worker women (38 ± 7.3 years old) completed a 16-week intervention randomly assigned to: (1) dance fitness group based on Zumba Fitness classes (DF group,  n  = 25)], (2) dance fitness + functional strength training group (DFFT group,  n  = 20), and (3) control group ( n  = 20). HRQoL was assessed by the 36-Item Short-Form Health-Survey (SF-36), which evaluates 8 dimensions of health [General Health (GH), Physical Functioning (PF), Social Functioning (SF), Physical Role (PR), Emotional Role (ER), Bodily Pain (BP), Vitality (V), and Mental Health (MH)] scored from 0 (worst) to 100 (best health status).  Results : The control group statistically differed from both exercise groups in PF and PR, and from the DF group in SF and MH showing a lower score. No statistical differences were observed between exercise groups post-intervention, except in V. DF group showed increases in GH, PF, SF, V, PR, and MH post-intervention.  Conclusion : A 16-week dance fitness intervention based on Zumba Fitness classes generates notable improvements in a wide range of HRQoL dimensions in sedentary middle-aged worker women, especially in V, PR and MH dimensions.",2020,"The control group statistically differed from both exercise groups in PF and PR, and from the DF group in SF and MH showing a lower score.","['sedentary middle-aged worker women', '65 sedentary middle-aged worker women (38 ± 7.3 years old', 'Sedentary Women', 'sedentary worker women']","['dance fitness group based on Zumba Fitness classes (DF group,  n  = 25)], (2) dance fitness + functional strength training group (DFFT group,  n  = 20), and (3) control group']","['Health-Related Quality of Life (HRQoL', 'HRQoL', 'health [General Health (GH), Physical Functioning (PF), Social Functioning (SF), Physical Role (PR), Emotional Role (ER), Bodily Pain (BP), Vitality (V), and Mental Health (MH)] scored from 0 (worst) to 100 (best health status', 'GH, PF, SF, V, PR, and MH post-intervention', 'Health-Related Quality of Life', 'HRQoL dimensions']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",65.0,0.0337697,"The control group statistically differed from both exercise groups in PF and PR, and from the DF group in SF and MH showing a lower score.","[{'ForeName': 'Yaira', 'Initials': 'Y', 'LastName': 'Barranco-Ruiz', 'Affiliation': 'Department of Physical Education and Sports, PROFITH ""PROmoting FITness and Health through physical activity"" Research Group, Sport and Health University Research Institute (iMUDS), Faculty of Education and Sport Sciences, University of Granada, 52071 Melilla, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Paz-Viteri', 'Affiliation': 'Pedagogy School of Physical Activity and Sports, Faculty of Education Sciences, National University of Chimborazo, 060150 Riobamba, Ecuador.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Villa-González', 'Affiliation': 'Department of Physical Education and Sports, PROFITH ""PROmoting FITness and Health through physical activity"" Research Group, Sport and Health University Research Institute (iMUDS), Faculty of Education and Sport Sciences, University of Granada, 52071 Melilla, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17113771']
1253,32466588,"Effect of Neuromuscular Electrical Stimulation on Masseter Muscle Thickness and Maximal Bite Force Among Healthy Community-Dwelling Persons Aged 65 Years and Older: A Randomized, Double Blind, Placebo-Controlled Study.","AIM


This study investigated the effect of neuromuscular electrical stimulation (NMES) on masseter muscle thickness and maximal bite force among healthy community-dwelling elderly persons older than 65 years.
MATERIALS AND METHODS


A total of 40 participants were randomly assigned to the experimental and placebo groups. In the experimental group, NMES was applied to both masseter muscles, and electrical signals were gradually increased until the participants felt a grabbing sensation (range 6.0-7.5 mA) in the masseter muscle. The placebo group, in contrast, underwent NMES in the same manner and procedure as the experimental group with less electrical intensity (0.5 mA). All interventions were administered five times a week for six weeks, 20 min per day. The outcomes were masseter muscle thickness assessed using ultrasound and maximal bite force using a bite force meter. The level of significance was set as  p  < 0.05.
RESULTS


The experimental group showed a significant increase in both masseter muscle thickness and maximal bite force as compared with the placebo group (p = 0.002 and 0.019, respectively). Moreover, the degree of change in the masseter muscle thickness and maximal bite force significantly increased in the experimental and placebo groups (p < 0.001, both).
CONCLUSIONS


This study demonstrated that NMES could be an effective modality for increasing masseter muscle thickness and maximal bite force in healthy older adults.",2020,"The experimental group showed a significant increase in both masseter muscle thickness and maximal bite force as compared with the placebo group (p = 0.002 and 0.019, respectively).","['A total of 40 participants', 'healthy community-dwelling elderly persons older than 65 years', 'Aged 65 Years and Older', 'Healthy Community-Dwelling Persons', 'healthy older adults']","['Placebo', 'NMES', 'neuromuscular electrical stimulation (NMES', 'Neuromuscular Electrical Stimulation', 'placebo']","['electrical intensity', 'Masseter Muscle Thickness and Maximal Bite Force', 'masseter muscle thickness assessed using ultrasound and maximal bite force using a bite force meter', 'masseter muscle thickness and maximal bite force']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0024876', 'cui_str': 'Masseter muscle structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0005654', 'cui_str': 'Masticatory Force'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0441074', 'cui_str': 'Meters'}]",40.0,0.200011,"The experimental group showed a significant increase in both masseter muscle thickness and maximal bite force as compared with the placebo group (p = 0.002 and 0.019, respectively).","[{'ForeName': 'Moon-Young', 'Initials': 'MY', 'LastName': 'Chang', 'Affiliation': 'Department of Occupational Therapy, Inje University, Gimhae 50834, Korea.'}, {'ForeName': 'Gihyoun', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Young-Jin', 'Initials': 'YJ', 'LastName': 'Jung', 'Affiliation': 'Department of Radiological Science, Health Sciences Division, Dongseo University, Busan 47011, Korea.'}, {'ForeName': 'Ji-Su', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Advanced Human Resource Development Project Group for Health Care in Aging Friendly Industry, Dongseo University, Busan 47011, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17113783']
1254,32468956,"Pembrolizumab or Placebo Plus Etoposide and Platinum as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer: Randomized, Double-Blind, Phase III KEYNOTE-604 Study.","PURPOSE


Pembrolizumab monotherapy has shown antitumor activity in patients with small-cell lung cancer (SCLC). The randomized, double-blind, phase III KEYNOTE-604 study compared pembrolizumab plus etoposide and platinum (EP) with placebo plus EP for patients with previously untreated extensive-stage (ES) SCLC.
METHODS


Eligible patients were randomly assigned 1:1 to pembrolizumab 200 mg once every 3 weeks or saline placebo for up to 35 cycles plus 4 cycles of EP. Primary end points were progression-free survival (PFS; RECIST version 1.1, blinded central review) and overall survival (OS) in the intention-to-treat population. Objective response rate (ORR) and duration of response were secondary end points. Prespecified efficacy boundaries were one-sided  P  = .0048 for PFS and .0128 for OS.
RESULTS


Of the 453 participants, 228 were randomly assigned to pembrolizumab plus EP and 225 to placebo plus EP. Pembrolizumab plus EP significantly improved PFS (hazard ratio [HR], 0.75; 95% CI, 0.61 to 0.91;  P  = .0023). Twelve-month PFS estimates were 13.6% with pembrolizumab plus EP and 3.1% with placebo plus EP. Although pembrolizumab plus EP prolonged OS, the significance threshold was not met (HR, 0.80; 95% CI, 0.64 to 0.98;  P  = .0164). Twenty-four-month OS estimates were 22.5% and 11.2%, respectively. ORR was 70.6% in the pembrolizumab plus EP group and 61.8% in the placebo plus EP group; the estimated proportion of responders remaining in response at 12 months was 19.3% and 3.3%, respectively. In the pembrolizumab plus EP and placebo plus EP groups, respectively, any-cause adverse events were grade 3-4 in 76.7% and 74.9%, grade 5 in 6.3% and 5.4%, and led to discontinuation of any drug in 14.8% and 6.3%.
CONCLUSION


Pembrolizumab plus EP significantly improved PFS compared with placebo plus EP as first-line therapy for patients with ES-SCLC. No unexpected toxicities were seen with pembrolizumab plus EP. These data support the benefit of pembrolizumab in ES-SCLC.",2020,"Pembrolizumab plus EP significantly improved PFS (hazard ratio [HR], 0.75; 95% CI, 0.61 to 0.91;  P  = .0023).","['453 participants', 'patients with ES-SCLC', 'patients with small-cell lung cancer (SCLC', 'Extensive-Stage Small-Cell Lung Cancer', 'Eligible patients', 'patients with previously untreated extensive-stage (ES) SCLC']","['Pembrolizumab or Placebo Plus Etoposide and Platinum', 'pembrolizumab plus EP', 'placebo plus EP', 'Pembrolizumab plus EP', 'pembrolizumab 200 mg once every 3 weeks or saline placebo', 'pembrolizumab plus EP and placebo plus EP', 'Pembrolizumab monotherapy', 'pembrolizumab plus etoposide and platinum (EP) with placebo plus EP']","['PFS', 'Objective response rate (ORR) and duration of response', 'toxicities', 'ORR', 'progression-free survival (PFS; RECIST version 1.1, blinded central review) and overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278726', 'cui_str': 'Small cell lung cancer extensive stage'}, {'cui': 'C0149925', 'cui_str': 'Small cell carcinoma of lung'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",453.0,0.588583,"Pembrolizumab plus EP significantly improved PFS (hazard ratio [HR], 0.75; 95% CI, 0.61 to 0.91;  P  = .0023).","[{'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Rudin', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Awad', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Navarro', 'Affiliation': ""Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Gottfried', 'Affiliation': 'Meir Medical Center, Kfar-Saba, Israel.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Csőszi', 'Affiliation': 'Hetényi Géza Kórház Onkológiai Központ, Szolnok, Hungary.'}, {'ForeName': 'Parneet K', 'Initials': 'PK', 'LastName': 'Cheema', 'Affiliation': 'William Osler Health System, University of Toronto, Brampton, Ontario, Canada.'}, {'ForeName': 'Delvys', 'Initials': 'D', 'LastName': 'Rodriguez-Abreu', 'Affiliation': 'Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Mirjana', 'Initials': 'M', 'LastName': 'Wollner', 'Affiliation': 'Rambam Medical Center, Haifa, Israel.'}, {'ForeName': 'James Chih-Hsin', 'Initials': 'JC', 'LastName': 'Yang', 'Affiliation': 'National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Mazieres', 'Affiliation': 'Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Orlandi', 'Affiliation': 'Oncología-Health and Care, Santiago, Chile.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Luft', 'Affiliation': 'Leningrad Regional Clinical Hospital, St Petersburg, Russia.'}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Gümüş', 'Affiliation': 'Istanbul Medeniyet University Hospital, Istanbul, Turkey.'}, {'ForeName': 'Terufumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Kalemkerian', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Merck & Co, Kenilworth, NJ.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Ebiana', 'Affiliation': 'Merck & Co, Kenilworth, NJ.'}, {'ForeName': 'M Catherine', 'Initials': 'MC', 'LastName': 'Pietanza', 'Affiliation': 'Merck & Co, Kenilworth, NJ.'}, {'ForeName': 'Hye Ryun', 'Initials': 'HR', 'LastName': 'Kim', 'Affiliation': 'Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00793']
1255,32469906,"Training intervention to improve hygiene practices in Islamic boarding school in Yogyakarta, Indonesia: A mixed-method study.","BACKGROUND


The primary objective of this study was to determine the effect of a training intervention in overall improvement in students' (santris) knowledge, behavior, and outcome.
METHODS


A mixed-methods exploratory sequential design was applied. First, qualitative data were collected from three focus group discussions with 20 supervisors and one in-depth interview with school principal to explore current hygiene practices. The information was then used to develop training intervention using either video, poster, and leaflet. To measure the effect, a stepped wedge cluster design with pre- and post-test analyses was conducted. A total of 452 junior high school santris in one Islamic boarding school were non-randomly allocated to either three intervention groups. Outcome measures were knowledge, personal behavior, and room hygiene. Codes and categories were produced in the qualitative analysis, while paired t-tests and Wilcoxon rank tests test were used in the quantitative analysis.
RESULTS


The qualitative study identified poor practices on personal and room hygiene among the santris and proposed a training intervention. Overall, there was a significant increase in knowledge and personal behavior after the intervention (7.22 ± 1.34 pre-intervention to 7.70 ± 0.74 post-intervention and 9.75 ± 2.98 pre-intervention to 12.16 ± 2.12 post-intervention, respectively, p < 0.001). Room hygiene was significantly improved among boys and those who received leaflets.
CONCLUSION


Having developed a specific training materials, school-based hygiene training intervention improved knowledge and personal behavior. Its effect on room hygiene particularly for female santris needs further strengthening of the intervention in this Islamic boarding school setting.",2020,"Overall, there was a significant increase in knowledge and personal behavior after the intervention (7.22 ± 1.34 pre-intervention to 7.70 ± 0.74 post-intervention and 9.75 ± 2.98 pre-intervention to 12.16 ± 2.12 post-intervention, respectively, p < 0.001).","['Islamic boarding school in Yogyakarta, Indonesia', '452 junior high school santris in one Islamic boarding school']","['training intervention', 'Training intervention']","[""overall improvement in students' (santris) knowledge, behavior, and outcome"", 'knowledge and personal behavior', 'Room hygiene', 'knowledge, personal behavior, and room hygiene']","[{'cui': 'C0022126', 'cui_str': 'Islam'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}]",452.0,0.0218919,"Overall, there was a significant increase in knowledge and personal behavior after the intervention (7.22 ± 1.34 pre-intervention to 7.70 ± 0.74 post-intervention and 9.75 ± 2.98 pre-intervention to 12.16 ± 2.12 post-intervention, respectively, p < 0.001).","[{'ForeName': 'Vita', 'Initials': 'V', 'LastName': 'Widyasari', 'Affiliation': 'International Health, Public Health Graduate Program, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Yayi Suryo', 'Initials': 'YS', 'LastName': 'Prabandari', 'Affiliation': 'Department of Health Behavior, Environment, and Social Medicine, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Utarini', 'Affiliation': 'Department of Health Policy and Management, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}]",PloS one,['10.1371/journal.pone.0233267']
1256,32471080,"Effectiveness of a Family Intervention to Increase Physical Activity in Disadvantaged Areas-A Healthy Generation, a Controlled Pilot Study.","There are large social inequalities in health. The purpose of this study was to evaluate the effects of a family intervention on physical activity (PA) and sedentary time (ST) in children and their parents. In this controlled pilot study, all 8-9-year-old children from four schools from a socioeconomically disadvantaged area in Sweden were invited and 67 children and 94 parents were included. The intervention was run by a foundation in co-operation with the municipality. The 9-month program included: (1) activity sessions, (2) healthy meals, (3) health information and (4) parental support groups. PA was primary outcome and ST was secondary outcome, measured by accelerometry. In total, 40 of the children (60%) and 45 of the adults (50%) had at least one day of valid accelerometer data at both baseline and follow-up. Significant intervention effects for the whole group were found in total PA ( p  = 0.048, mean difference (MD) intervention/control 150 counts per minute) and in vigorous PA ( p  = 0.02, MD 8 min/day) during the weekends. There were no differences between groups in the other PA variables or ST. This pilot study shows that it is possible to influence PA in families from a disadvantaged area through a family program.",2020,"Significant intervention effects for the whole group were found in total PA ( p  = 0.048, mean difference (MD) intervention/control 150 counts per minute) and in vigorous PA ( p  = 0.02, MD 8 min/day) during the weekends.","['all 8-9-year-old children from four schools from a socioeconomically disadvantaged area in Sweden were invited and 67 children and 94 parents were included', 'families from a disadvantaged area through a family program', 'Disadvantaged Areas', 'children and their parents']","['activity sessions, (2) healthy meals, (3) health information and (4) parental support groups', 'family intervention', 'Family Intervention']","['physical activity (PA) and sedentary time (ST', 'total PA']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0418946', 'cui_str': 'Parental support'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0240404,"Significant intervention effects for the whole group were found in total PA ( p  = 0.048, mean difference (MD) intervention/control 150 counts per minute) and in vigorous PA ( p  = 0.02, MD 8 min/day) during the weekends.","[{'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Nyberg', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, 171 77 Stockholm, Sweden.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Andermo', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, 171 77 Stockholm, Sweden.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Nordenfelt', 'Affiliation': 'The Foundation A Healthy Generation, 118 63 Stockholm, Sweden.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Lidin', 'Affiliation': 'Department of Medicine, Karolinska Institutet, 171 76 Stockholm, Sweden.'}, {'ForeName': 'Mai-Lis', 'Initials': 'ML', 'LastName': 'Hellénius', 'Affiliation': 'Department of Medicine, Karolinska Institutet, 171 76 Stockholm, Sweden.'}]",International journal of environmental research and public health,['10.3390/ijerph17113794']
1257,32471186,Vitamin E-Bonded Membranes Do Not Influence Markers of Oxidative Stress in Hemodialysis Patients with Homozygous Glutathione Transferase M1 Gene Deletion.,"BACKGROUND


Increased oxidative stress is a hallmark of end-stage renal disease. Hemodialysis (HD) patients lacking glutathione transferase M1 (GSTM1) enzyme activity exhibit enhanced oxidative DNA damage and higher mortality rate than those with active GSTM1 enzyme. To our knowledge, this is the first study to use the vitamin E-bonded membranes (VEM) in patients with homozygous  GSTM1  gene deletion, and we aimed to determine the effect of VEM on oxidative and inflammatory status in HD patients with homozygous  GSTM1  gene deletion.
METHODS


GSTM1  genotypes were determined by polymerase chain reaction (PCR) in 170 chronic HD patients. Those with  GSTM1-null  genotype were randomized and 80 were included in the study. Forty of them were dialyzed for three months with VEM, while the other forty were dialyzed with high-flux same-surface polysulfone dialyzers. Markers of protein and lipid oxidative damage and inflammation (thiol groups, malondialdehyde (MDA), Interleukin-6 (IL-6)), together with plasma antioxidant activity (glutathione peroxidase (GPX), superoxide dismutase (SOD)) were determined.
RESULTS


Seventy-five patients finished the study. There were no differences at baseline in markers of protein and lipid oxidative damage, inflammation and plasma antioxidant activity. After three months of therapy, GPX, MDA, and thiol groups increased significantly in both groups, but without statistical significance between groups. SOD and C reactive protein (CRP) did not change significantly during the three-month period. IL-6 increased in the control group, and at the same time, decreased in the VEM group, but without statistical significance. Hemoglobin (Hb) value, red blood cells, erythropoiesis resistance index (ERI), serum ferritin and iron did not change significantly within or between groups. Regarding other laboratory parameters, proteins, albumins, triglycerides, serum phosphorus, serum bicarbonate and Kt/V showed significant improvements within groups but with no significant difference between groups.
CONCLUSIONS


Our data shows that therapy with VEM over three months had no benefit over standard polysulfone membrane in decreasing by-products of oxidative stress and inflammation in dialysis patients lacking GSTM1 enzyme activity.",2020,"After three months of therapy, GPX, MDA, and thiol groups increased significantly in both groups, but without statistical significance between groups.","['Seventy-five patients finished the study', '170 chronic HD patients', 'Hemodialysis Patients with Homozygous Glutathione Transferase M1 Gene Deletion', 'patients with homozygous  GSTM1  gene deletion', 'Those with  GSTM1-null  genotype were randomized and 80 were included in the study', 'HD patients with homozygous  GSTM1  gene deletion']","['VEM', 'Vitamin E-Bonded Membranes', 'polymerase chain reaction (PCR', 'vitamin E-bonded membranes (VEM']","['Hemoglobin (Hb) value, red blood cells, erythropoiesis resistance index (ERI), serum ferritin and iron', 'Markers of protein and lipid oxidative damage and inflammation (thiol groups, malondialdehyde (MDA), Interleukin-6 (IL-6)), together with plasma antioxidant activity (glutathione peroxidase (GPX), superoxide dismutase (SOD', 'Oxidative Stress', 'SOD and C reactive protein (CRP', 'markers of protein and lipid oxidative damage, inflammation and plasma antioxidant activity', 'IL-6', 'triglycerides, serum phosphorus, serum bicarbonate and Kt/V']","[{'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C1740835', 'cui_str': 'Chronic haemodialysis'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0019904', 'cui_str': 'Homozygote'}, {'cui': 'C0017837', 'cui_str': 'Glutathione transferase'}, {'cui': 'C0017260', 'cui_str': 'Gene deletion'}, {'cui': 'C1738886', 'cui_str': 'GSTM1 protein, human'}, {'cui': 'C0456148', 'cui_str': 'Null'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0038734', 'cui_str': 'Sulfhydryls'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C0429662', 'cui_str': 'kt/V'}]",170.0,0.0267835,"After three months of therapy, GPX, MDA, and thiol groups increased significantly in both groups, but without statistical significance between groups.","[{'ForeName': 'Petar', 'Initials': 'P', 'LastName': 'Djuric', 'Affiliation': 'Clinical Department for Renal Diseases, Zvezdara University Medical Center, 11000 Belgrade, Serbia.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Suvakov', 'Affiliation': 'Institute of Medical and Clinical Biochemistry, 11000 Belgrade, Serbia.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Simic', 'Affiliation': 'Institute of Medical and Clinical Biochemistry, 11000 Belgrade, Serbia.'}, {'ForeName': 'Dragana', 'Initials': 'D', 'LastName': 'Markovic', 'Affiliation': 'Clinical Department for Renal Diseases, Zvezdara University Medical Center, 11000 Belgrade, Serbia.'}, {'ForeName': 'Djurdja', 'Initials': 'D', 'LastName': 'Jerotic', 'Affiliation': 'Institute of Medical and Clinical Biochemistry, 11000 Belgrade, Serbia.'}, {'ForeName': 'Aleksandar', 'Initials': 'A', 'LastName': 'Jankovic', 'Affiliation': 'Clinical Department for Renal Diseases, Zvezdara University Medical Center, 11000 Belgrade, Serbia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Bulatovic', 'Affiliation': 'Clinical Department for Renal Diseases, Zvezdara University Medical Center, 11000 Belgrade, Serbia.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Tosic Dragovic', 'Affiliation': 'Clinical Department for Renal Diseases, Zvezdara University Medical Center, 11000 Belgrade, Serbia.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Damjanovic', 'Affiliation': 'Clinical Department for Renal Diseases, Zvezdara University Medical Center, 11000 Belgrade, Serbia.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Marinkovic', 'Affiliation': 'Institute of Medical Statistics and Informatics, Faculty of Medicine, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Radomir', 'Initials': 'R', 'LastName': 'Naumovic', 'Affiliation': 'Clinical Department for Renal Diseases, Zvezdara University Medical Center, 11000 Belgrade, Serbia.'}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Dimkovic', 'Affiliation': 'Clinical Department for Renal Diseases, Zvezdara University Medical Center, 11000 Belgrade, Serbia.'}]",Toxins,['10.3390/toxins12060352']
1258,32473338,Outcomes of elective use of the chimney endovascular technique in pararenal aortic pathologic processes.,"OBJECTIVE


In the treatment of pararenal abdominal aortic aneurysms and aortic pathologic processes, chimney endovascular aneurysm repair (CHEVAR) represents an alternative technique for urgent cases. The aim of the study was to evaluate the outcomes of CHEVAR in the elective setting.
METHODS


We performed a retrospective analysis of prospectively collected records of 165 consecutive asymptomatic CHEVAR patients who were treated between March 2009 and January 2018 with the Endurant stent graft (Medtronic, Santa Rosa, Calif). A total of 244 chimney grafts (CGs) were implanted. The primary end point was clinical success, defined as freedom from procedure-related mortality, persistent type IA endoleak, occlusion or high-grade stenosis (>70%) of CGs, and any chimney technique-related secondary procedure for the entire follow-up period. Secondary clinical success included patients with successful treatment of a primary end point with a secondary endovascular procedure.
RESULTS


All 244 targeted chimney vessels were successfully cannulated. Total perioperative morbidity was 7.8% (n = 13), including 3 (1.8%) cases of bowel ischemia, 1 (0.6%) patient with renal ischemia, and 1 patient (0.6%) with stroke. Median follow-up was 25.5 ± 2.2 months. Both 30-day and follow-up procedure-related mortality rates were 1.8% (n = 3). Primary and secondary freedom from persistent type IA endoleak rates were 96.4% (n = 159) and 99.4% (n = 164), respectively. Primary and secondary CG patency rates were 92.2% (n = 225) and 95.9% (n = 234), respectively. The rate of reinterventions related to the chimney technique was 10.9% (n = 18), and 83.3% of them were performed by endovascular means. The estimated cumulative primary patency and freedom from persistent type IA endoleak were 87.5% and 95.3%, respectively, and the primary and secondary clinical successes rates at midterm were 80.3% and 87.5%, respectively.
CONCLUSIONS


The elective use of CHEVAR with the Endurant stent graft in our series showed favorable midterm clinical results, which are similar to the published results of other total endovascular modalities. A prospective randomized trial of elective treatment of pararenal abdominal aortic aneurysms and aortic pathologic processes with current endovascular options is needed to assess the value of CHEVAR in the elective setting.",2020,"Primary endpoint was the clinical success defined as freedom from procedure-related mortality, persistent type Ia endoleak, occlusion or high-grade stenosis (>70%) of CGs and from any chimney technique related secondary procedure for the entire follow-up period.","['pararenal aortic pathologic processes', '165 consecutive asymptomatic CHEVAR patients, which were treated between March 2009 and January 2018 with the Endurant stent-graft (Medtronic, Santa-Rosa, CA, USA', 'A total of 244 chimney-grafts (CGs']","['chimney EVAR (CHEVAR', 'elective PAA', 'CHEVAR', 'chimney endovascular technique', 'CHEVAR technique with the Endurant stent-graft']","['persistent type Ia endoleak rates', 'mortality rates', 'cumulative primary patency and freedom from persistent type Ia Endoleak', 'chimney technique reinterventions rate', 'bowel ischemia', 'clinical success defined as freedom from procedure-related mortality, persistent type Ia endoleak, occlusion or high-grade stenosis', 'Total perioperative morbidity', 'secondary chimney grafts patency rates', 'renal ischemia']","[{'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0030660', 'cui_str': 'Pathological process'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0557689', 'cui_str': 'Chimney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517660', 'cui_str': '244'}]","[{'cui': 'C0557689', 'cui_str': 'Chimney'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0267964', 'cui_str': 'Pancreatic acinar atrophy'}, {'cui': 'C2936204', 'cui_str': 'Intravascular Techniques'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]","[{'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1504464', 'cui_str': 'Endoleak'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0557689', 'cui_str': 'Chimney'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0156149', 'cui_str': 'Gastrointestinal tract vascular insufficiency'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0920646', 'cui_str': 'Ischemia of kidney'}]",165.0,0.0322111,"Primary endpoint was the clinical success defined as freedom from procedure-related mortality, persistent type Ia endoleak, occlusion or high-grade stenosis (>70%) of CGs and from any chimney technique related secondary procedure for the entire follow-up period.","[{'ForeName': 'Georgios A', 'Initials': 'GA', 'LastName': 'Pitoulias', 'Affiliation': 'Department of Vascular Surgery, St. Franziskus Hospital Münster, Münster, Germany; Second Department of Surgery, Division of Vascular Surgery, School of Medicine, Aristotle University of Thessaloniki, ""G. Gennimatas"" Hospital, Thessaloniki, Greece. Electronic address: pitoulias@yahoo.com.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Torsello', 'Affiliation': 'Department of Vascular Surgery, St. Franziskus Hospital Münster, Münster, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Austermann', 'Affiliation': 'Department of Vascular Surgery, St. Franziskus Hospital Münster, Münster, Germany.'}, {'ForeName': 'Apostolos G', 'Initials': 'AG', 'LastName': 'Pitoulias', 'Affiliation': 'Second Department of Surgery, Division of Vascular Surgery, School of Medicine, Aristotle University of Thessaloniki, ""G. Gennimatas"" Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Marco D', 'Initials': 'MD', 'LastName': 'Pipitone', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Cardiovascular Department, University Hospital of Cattinara ASUITs, Trieste, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Fazzini', 'Affiliation': 'Department of Vascular Surgery, St. Franziskus Hospital Münster, Münster, Germany.'}, {'ForeName': 'Konstantinos P', 'Initials': 'KP', 'LastName': 'Donas', 'Affiliation': 'Department of Vascular Surgery, Research Vascular Centre, Asklepios Clinic Langen, University of Frankfurt, Langen, Germany.'}]",Journal of vascular surgery,['10.1016/j.jvs.2020.05.029']
1259,32473046,"A randomized, controlled trial comparing the immunogenecity and safety of a 23-valent pneumococcal polysaccharide vaccination to a repeated dose 13-valent pneumococcal conjugate vaccination in kidney transplant recipients.","BACKGROUND


The risk of invasive pneumococcal disease is significant among solid organ transplant (SOT) recipients. The optimal pneumococcal vaccination strategy for SOT patients is not known.
METHODS


The potential kidney transplant recipients in dialysis were randomized into two arms: to receive a 23-valent pneumococcal polysaccharide vaccine (PPV23) before transplantation or to receive a 13-valent pneumococcal conjugate vaccine (PCV13) before transplantation and a second dose of PCV13 six months after the transplantation. Serotype-specific antibody concentrations and opsonophagocytic activity (OPA) were measured before and after the first vaccination (visits V1,V2) and six and seven months after the transplantation, for example, before and after the second PCV13 (visits V3,V4).
RESULTS


Out of 133 participants, 48 (PCV13 arm) and 46 (PPV23 arm) received a kidney transplant, and 37 + 37 in both arms completed the study. After the first vaccination, the geometric mean concentrations (GMCs) in the PCV13 arm were significantly higher for 9/13 serotypes and the OPA geometric mean titers (GMTs) were significantly higher for 4/13 serotypes. At V3, the antibody levels had declined but OPA remained significantly higher for 7/13 (PCV13) vs 4/13 (PPV23) serotypes. At V4, the GMCs for 9/13 serotypes and the GMTs for 12/13 serotypes were significantly higher in the PCV13 arm. The GMCs but not GMTs were lower than at V2. There was no difference in adverse effects. No vaccine-related allograft rejection was detected.
CONCLUSIONS


The immunogenicity of PCV13 was better in dialysis patients, and revaccination with PCV13 was immunogenic and safe.",2020,"The immunogenicity of PCV13 was better in dialysis patients, and revaccination with PCV13 was immunogenic and safe .","['kidney transplant recipients in dialysis', 'Out of 133 participants, 48 (PCV13 arm) and 46 (PPV23 arm) received a kidney transplant, and 37 + 37 in both arms completed the study', 'kidney transplant recipients', 'solid organ transplant (SOT) recipients', 'SOT patients']","['23-valent pneumococcal polysaccharide vaccine (PPV23) before transplantation or to receive a 13-valent pneumococcal conjugate vaccine (PCV13', '23-valent pneumococcal polysaccharide vaccination']","['geometric mean concentrations (GMCs', 'allograft rejection', 'immunogenicity of PCV13', 'OPA', 'adverse effects', 'antibody levels', 'OPA geometric mean titres (GMTs', 'Serotype-specific antibody concentrations and opsonophagocytic activity (OPA']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0730400', 'cui_str': 'Solid organ transplant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0961101', 'cui_str': '23-valent pneumococcal capsular polysaccharide vaccine'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C3152625', 'cui_str': 'Pneumococcal 13-valent conjugate vaccine'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody'}]",133.0,0.0617085,"The immunogenicity of PCV13 was better in dialysis patients, and revaccination with PCV13 was immunogenic and safe .","[{'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Eriksson', 'Affiliation': 'HUH Inflammation Center, Division of Infectious Diseases of Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Käyhty', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Saha', 'Affiliation': 'Division of Nephrology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Lahdenkari', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Petri', 'Initials': 'P', 'LastName': 'Koskinen', 'Affiliation': 'HUH Abdominal Center, Division of Nephrology, Helsinki University Hospital and Helsinki University, Helsinki, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Mäkisalo', 'Affiliation': 'HUH Abdominal Center, Division of Liver Diseases and Transplantation, Helsinki University Hospital and Helsinki University, Helsinki, Finland.'}, {'ForeName': 'Veli-Jukka', 'Initials': 'VJ', 'LastName': 'Anttila', 'Affiliation': 'HUH Inflammation Center, Division of Infectious Diseases of Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}]",Transplant infectious disease : an official journal of the Transplantation Society,['10.1111/tid.13343']
1260,32474427,Development and evaluation of a patient-centred program for low anterior resection syndrome: protocol for a randomized controlled trial.,"INTRODUCTION


Low anterior resection syndrome (LARS) is described as disordered bowel function after rectal resection that leads to a detriment in quality of life, and affects the majority of individuals following restorative proctectomy for rectal cancer. The management of LARS includes personalised troubleshooting and effective self-management behaviours. Thus, affected individuals need to be well informed and appropriately engaged in their own LARS management. This manuscript describes the development of a LARS patient-centred programme (LPCP) and the study protocol for its evaluation in a randomised controlled trial.
METHODS AND ANALYSIS


This will be a multicentre, randomised, assessor-blind, parallel-groups, pragmatic trial evaluating the impact of an LPCP, consisting of an informational booklet, patient diaries and nurse support, on patient-reported outcomes after restorative proctectomy for rectal cancer. The informational booklet was developed by a multidisciplinary LARS team, and was vetted in a focus group and semistructured interviews involving patients, caregivers, and healthcare professionals. The primary outcome will be global quality of life (QoL), as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30), at 6 months after surgery. The treatment effect on global QoL will be modelled using generalised estimating equations. Secondary outcomes include symptom change, patient activation, bowel function measures, emotional distress, knowledge about LARS and satisfaction with the LPCP.
ETHICS AND DISSEMINATION


The Research Ethics Committee (REC) at the Integrated Health and Social Services Network for West-Central Montreal (health network responsible for the Jewish General Hospital) is the overseeing REC for all Quebec sites. They have granted ethical approval (MP-05-2019-1628) for all Quebec hospitals (Jewish General Hospital, McGill University Health Center, CHU de Quebec) and have granted full authorisation to begin research at the Jewish General Hospital. Patient recruitment will not begin at the other Quebec sites until inter-institutional contracts are finalised and feasibility/authorisation for research is granted by their respective REC. The results of this study will be presented at national and international conferences, and a manuscript with results will be submitted for publication in a high-impact peer-reviewed journal.
TRIAL REGISTRATION NUMBER


NCT03828318; Pre-results.",2020,"Secondary outcomes include symptom change, patient activation, bowel function measures, emotional distress, knowledge about LARS and satisfaction with the LPCP.
","['for rectal cancer', 'low anterior resection syndrome']","['restorative proctectomy', 'LARS patient-centred programme (LPCP']","['symptom change, patient activation, bowel function measures, emotional distress, knowledge about LARS and satisfaction with the LPCP', 'global quality of life (QoL), as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30']","[{'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C4524073', 'cui_str': 'Low anterior resection syndrome'}]","[{'cui': 'C0193062', 'cui_str': 'Resection of rectum'}, {'cui': 'C4524073', 'cui_str': 'Low anterior resection syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C4524073', 'cui_str': 'Low anterior resection syndrome'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.228641,"Secondary outcomes include symptom change, patient activation, bowel function measures, emotional distress, knowledge about LARS and satisfaction with the LPCP.
","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Garfinkle', 'Affiliation': 'Division of Colon and Rectal Surgery, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Carmen G', 'Initials': 'CG', 'LastName': 'Loiselle', 'Affiliation': 'Department of Oncology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Julio F', 'Initials': 'JF', 'LastName': 'Fiore', 'Affiliation': 'Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Liliana G', 'Initials': 'LG', 'LastName': 'Bordeianou', 'Affiliation': 'Section of Colon and Rectal Surgery, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'A Sender', 'Initials': 'AS', 'LastName': 'Liberman', 'Affiliation': 'Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Morin', 'Affiliation': 'Division of Colon and Rectal Surgery, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Faria', 'Affiliation': 'Division of Colon and Rectal Surgery, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Ghitulescu', 'Affiliation': 'Division of Colon and Rectal Surgery, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Carol-Ann', 'Initials': 'CA', 'LastName': 'Vasilevsky', 'Affiliation': 'Division of Colon and Rectal Surgery, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Sahir R', 'Initials': 'SR', 'LastName': 'Bhatnagar', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Marylise', 'Initials': 'M', 'LastName': 'Boutros', 'Affiliation': 'Division of Colon and Rectal Surgery, Jewish General Hospital, Montreal, Quebec, Canada maryliseboutros@gmail.com.'}]",BMJ open,['10.1136/bmjopen-2019-035587']
1261,32475771,"Corrigendum to ""Effect of patient education on palliative care knowledge and acceptability of outpatient palliative care services among gynecologic oncology patients: A randomized controlled trial"" [Gynecol. Oncol. 156 (2020) 482-487].",,2020,,"['156 (2020', 'gynecologic oncology patients']",[],[],"[{'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],[],,0.0849144,,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Graul', 'Affiliation': ""Department of Gynecologic Oncology, St. Luke's University Health System, Bethlehem, PA, United States of America. Electronic address: Ashley.graul@sluhn.org.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Haggerty', 'Affiliation': 'Department of Gynecologic Oncology, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Stickley', 'Affiliation': 'Department of Gynecologic Oncology, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Department of Palliative Care, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Morales', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bogner', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Burger', 'Affiliation': 'Department of Gynecologic Oncology, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Morgan', 'Affiliation': 'Department of Gynecologic Oncology, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ko', 'Affiliation': 'Department of Gynecologic Oncology, University of Pennsylvania, Philadelphia, PA, United States of America.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.05.015']
1262,32476640,"Effects of the  Rango Cards  game intervention on food consumption, nutritional knowledge and self-efficacy in the adoption of healthy eating practices of high school students: a cluster randomised controlled trial.","OBJECTIVE


The study aimed to assess the impact of a game-based nutritional intervention on food consumption, nutritional knowledge and self-efficacy in the adoption of healthy eating practices.
DESIGN


This cluster randomised controlled trial included both male and female high school students from private schools in the Federal District, Brazil. Four schools were randomly selected for each group. Investigated variables were age, sex, monthly family income, maternal education level, dietary perceptions and practices, nutritional knowledge and self-efficacy in the adoption of healthy eating practices.
SETTING


Intervention group participants were instructed to play Rango Cards, a digital game developed for the study, on their own, for a period of 7-17 d, while the control group was not provided with any game or material during the study.
PARTICIPANTS


The study included 319 adolescents (mean age = 15·8 (sd 0·7) years).
RESULTS


Significant reductions were observed in the intervention group compared with the control group for the following variables: habit of eating while watching TV or studying and having meals at fast food restaurants. The intervention group showed increased knowledge of the effects of fruit and vegetable consumption as well as improved self-efficacy in the adoption of healthy eating practices such as reducing Na intake and preparing healthy meals.
CONCLUSIONS


The design of Rango Cards is potentially capable of effecting positive changes. Therefore, the digital game promotes autonomy and self-care among adolescents with regard to healthy eating.",2020,"RESULTS


Significant reductions were observed in the intervention group compared with the control group for the following variables: habit of eating while watching TV or studying and having meals at fast food restaurants.","['The study included 319 adolescents (mean age = 15·8', 'healthy eating practices', 'adolescents with regard to healthy eating', 'healthy eating practices of high school students', 'male and female high school students from private schools in the Federal District, Brazil']","['play Rango Cards, a digital game', 'game-based nutritional intervention', 'Rango Cards  game intervention']","['knowledge of the effects of fruit and vegetable consumption', 'food consumption, nutritional knowledge and self-efficacy', 'self-efficacy']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0567466', 'cui_str': 'Eating practice'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",319.0,0.0509513,"RESULTS


Significant reductions were observed in the intervention group compared with the control group for the following variables: habit of eating while watching TV or studying and having meals at fast food restaurants.","[{'ForeName': 'Carolina Martins Dos Santos', 'Initials': 'CMDS', 'LastName': 'Chagas', 'Affiliation': 'Federal University of Lavras, Department of Nutrition,\xa0Minas Gerais37200-000, Brazil.'}, {'ForeName': 'Giselle Rhai-Sa', 'Initials': 'GR', 'LastName': 'Melo', 'Affiliation': 'University of Brasilia, School of Health Sciences, Graduate Program in Human Nutrition, Federal District, Brazil.'}, {'ForeName': 'Raquel Braz Assunção', 'Initials': 'RBA', 'LastName': 'Botelho', 'Affiliation': 'University of Brasilia, School of Health Sciences, Post-Graduate Program in Human Nutrition, Federal District, Brazil.'}, {'ForeName': 'Natacha', 'Initials': 'N', 'LastName': 'Toral', 'Affiliation': 'University of Brasilia, School of Health Sciences, Post-Graduate Program in Human Nutrition, Federal District, Brazil.'}]",Public health nutrition,['10.1017/S1368980020000531']
1263,32476659,Enhanced Enrollment in the National Diabetes Prevention Program to Increase Engagement and Weight Loss for the Underserved: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Type 2 diabetes affects 9.4% of US adults with higher rates among racial and ethnic minorities and individuals of low socioeconomic status. The National Diabetes Prevention Program (NDPP) is an evidence-based and widely disseminated behavioral intervention to reduce diabetes incidence through modest weight loss. However, retention in the yearlong NDPP is problematic and leads to suboptimal weight loss, especially among diverse, underserved populations. Strategies to improve NDPP engagement and weight loss are needed urgently. Pilot results of the pre-NDPP, a novel enhancement to enrollment in the NDPP based on the Health Belief Model, were highly successful in a nonrandomized cohort study among 1140 racially diverse, predominately low-income participants. A total of 75 presession participants had doubled attendance and weight loss as compared with earlier participants who did not receive presessions. On the basis of these promising results, we are conducting a randomized controlled trial (RCT) to determine whether pre-NDPP reliably improves NDPP outcomes, as reported on ClinicalTrials.gov.
OBJECTIVE


This study aims to (1) conduct an RCT comparing NDPP attendance and weight loss outcomes between participants who receive pre-NDPP versus direct enrollment into the NDPP (usual care), (2) examine potential effect mediators (perceived risk for developing diabetes and self-efficacy and readiness for weight control) and moderators (race and ethnicity; income level), and (3) evaluate implementation factors, including cost and projected return on investment.
METHODS


This two-arm RCT will compare outcomes among diverse, predominately low-income participants who receive pre-NDPP versus direct enrollment into the NDPP (usual care). This is a type 1 hybrid effectiveness-implementation design to determine clinical effectiveness through an RCT, while assessing factors that may impact future pre-NDPP dissemination and implementation, including cost. Our primary research question is whether pre-NDPP improves NDPP attendance and weight loss compared with standard NDPP delivery.
RESULTS


This project was funded in April 2019. Recruitment is underway as of July 2019. Initial participants began the intervention in October 2019. Data analysis and results reporting are expected to be completed in 2024.
CONCLUSIONS


This RCT of pre-NDPP may lead to future dissemination of a scalable, evidence-based strategy to improve success of the NDPP, reduce disparities in NDPP effectiveness, and help prevent type 2 diabetes across the country.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04022499; https://clinicaltrials.gov/ct2/show/NCT04022499.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/15499.",2020,A total of 75 presession participants had doubled attendance and weight loss as compared with earlier participants who did not receive presessions.,"['1140 racially diverse, predominately low-income participants', 'diverse, predominately low-income participants who receive pre-NDPP versus direct enrollment into the NDPP (usual care', 'Initial participants began the intervention in October 2019', 'participants who receive pre-NDPP versus direct enrollment into the NDPP (usual care']","['pre-NDPP', 'National Diabetes Prevention Program (NDPP']","['NDPP outcomes', 'NDPP attendance and weight loss', 'NDPP engagement and weight loss', 'doubled attendance and weight loss', 'cost and projected return on investment']","[{'cui': 'C4517539', 'cui_str': '1140'}, {'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0021953', 'cui_str': 'Investments'}]",75.0,0.145978,A total of 75 presession participants had doubled attendance and weight loss as compared with earlier participants who did not receive presessions.,"[{'ForeName': 'Natalie D', 'Initials': 'ND', 'LastName': 'Ritchie', 'Affiliation': 'Office of Research, Denver Health, Denver, CO, United States.'}, {'ForeName': 'Jodi Summers', 'Initials': 'JS', 'LastName': 'Holtrop', 'Affiliation': 'Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO, United States.'}, {'ForeName': 'R Mark', 'Initials': 'RM', 'LastName': 'Gritz', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science, University of Colorado School of Medicine, Aurora, CO, United States.'}, {'ForeName': 'Katherine Ann', 'Initials': 'KA', 'LastName': 'Sauder', 'Affiliation': 'Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO, United States.'}, {'ForeName': 'Michael Josh', 'Initials': 'MJ', 'LastName': 'Durfee', 'Affiliation': 'Office of Research, Denver Health, Denver, CO, United States.'}, {'ForeName': 'L Miriam', 'Initials': 'LM', 'LastName': 'Dickinson', 'Affiliation': 'Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO, United States.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Kaufmann', 'Affiliation': 'Villanova University College of Nursing, Philadelphia, PA, United States.'}]",JMIR research protocols,['10.2196/15499']
1264,32476658,Sustainability of Community-Based Specialized Mental Health Services in Five European Countries: Protocol for Five Randomized Controlled Trial-Based Health-Economic Evaluations Embedded in the RECOVER-E Program.,"BACKGROUND


Community-based recovery-oriented mental health services for people with severe mental disorders have not been fully implemented in Bulgaria, Croatia, Macedonia, Montenegro, and Romania. The RECOVER-E project facilitates the implementation of specialized mental health care delivered by setting up services, implementing the services, and evaluating multidisciplinary community mental health teams. The outcomes of the RECOVER-E project are assessed in a trial-based outcome evaluation in each of the participating countries with a health-economic evaluation linked to these trials.
OBJECTIVE


The aim of this protocol paper is to describe the methodology that will be used for the health-economic evaluation alongside the trials.
METHODS


Implementation sites have been selected in each of the five countries where hospital-based mental health services are available (care as usual [CAU]) for patients with severe mental disorders (severe depression, bipolar disorder, schizophrenia, and other psychotic disorders). The newly implemented health care system will involve community-based recovery-oriented mental health care (CMHC). At each site, 180 consenting patients will be randomized to either CAU or CMHC. Patient-level outcomes are personal and social functioning and quality-adjusted life years (QALYs). Data on participants' health care use will be collected and corresponding health care costs will be computed. This enables evaluation of health care costs of CMHC as compared with CAU, and these costs can be related to patient-level outcomes (functioning and QALY gains) in health-economic evaluation.
RESULTS


Data collection was started in December 2018 (Croatia), February 2019 (Montenegro), April 2019 (Romania), June 2019 (North Macedonia), and October 2019 (Bulgaria). The findings of the outcome evaluations will be reported for each of the five countries separately, and the five trials will be pooled for multilevel analysis on a combined dataset.
CONCLUSIONS


The results of the health-economic evaluation of the RECOVER-E project will contribute to the growing evidence base on the health and economic benefits of recovery-oriented and community-based service models for health systems in transition.
TRIAL REGISTRATION


(1) ClinicalTrials.gov NCT03922425 (Bulgaria); https://clinicaltrials.gov/ct2/show/NCT03922425 (2) ClinicalTrials.gov NCT03862209 (Croatia); https://clinicaltrials.gov/ct2/show/NCT03862209 (3) ClinicalTrials.gov NCT03892473 (Macedonia); https://clinicaltrials.gov/ct2/show/NCT03892473 (4) ClinicalTrials.gov NCT03837340 (Montenegro); https://clinicaltrials.gov/ct2/show/NCT03837340 (5) ClinicalTrials.gov NCT03884933 (Romania); https://clinicaltrials.gov/ct2/show/NCT03884933.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17454.",2020,"The outcomes of the RECOVER-E project are assessed in a trial-based outcome evaluation in each of the participating countries with a health-economic evaluation linked to these trials.
","['Implementation sites have been selected in each of the five countries where hospital-based mental health services are available (care as usual [CAU]) for patients with severe mental disorders (severe depression, bipolar disorder, schizophrenia, and other psychotic disorders', 'people with severe mental disorders', 'Five European Countries', '180 consenting patients']","['CAU or CMHC', 'Community-based recovery-oriented mental health services']",['personal and social functioning and quality-adjusted life years (QALYs'],"[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0444892', 'cui_str': 'CAU'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}]","[{'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",,0.29357,"The outcomes of the RECOVER-E project are assessed in a trial-based outcome evaluation in each of the participating countries with a health-economic evaluation linked to these trials.
","[{'ForeName': 'Ben F M', 'Initials': 'BFM', 'LastName': 'Wijnen', 'Affiliation': 'Center for Economic Evaluation and Machine Learning, Trimbos Institute, Utrecht, Netherlands.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Smit', 'Affiliation': 'Center for Economic Evaluation and Machine Learning, Trimbos Institute, Utrecht, Netherlands.'}, {'ForeName': 'Ana Ivičević', 'Initials': 'AI', 'LastName': 'Uhernik', 'Affiliation': 'Division of Public Health, Croatian Institute of Public Health, Zagreb, Croatia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Istvanovic', 'Affiliation': 'Division of Public Health, Croatian Institute of Public Health, Zagreb, Croatia.'}, {'ForeName': 'Jovo', 'Initials': 'J', 'LastName': 'Dedovic', 'Affiliation': 'Special Psychiatric Hospital Dobrota, Kotor, .'}, {'ForeName': 'Roumyana', 'Initials': 'R', 'LastName': 'Dinolova', 'Affiliation': 'National Centre of Public Health Protection-Mental Health, Sofia, Bulgaria.'}, {'ForeName': 'Raluca', 'Initials': 'R', 'LastName': 'Nica', 'Affiliation': 'Romanian League for Mental Health, Bucharest, Romania.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Velickovski', 'Affiliation': 'University Clinic of Psychiatry, Skopje, the Former Yugoslav Republic of Macedonia.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Wensing', 'Affiliation': 'Department of General Practice and Health Service Research, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Ionela', 'Initials': 'I', 'LastName': 'Petrea', 'Affiliation': 'Department of Public Mental Health, Trimbos Institute, Utrecht, Netherlands.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Shields-Zeeman', 'Affiliation': 'Department of Public Mental Health, Trimbos Institute, Utrecht, Netherlands.'}]",JMIR research protocols,['10.2196/17454']
1265,32598165,"Maternal Infant-Feeding Attitudes, Infant Eating Behaviors, and Maternal Feeding Choice at 3 and 6 Months Postpartum: A Comparative Multicenter International Study.","Objective:  The aim of this study was to compare mothers' attitudes toward infant feeding and infant eating behavior in different countries, and their associations with infant feeding at 3 and 6 months.  Methods:  Data from 164 mothers with healthy term infants recruited for a randomized trial comparing breast pumps from the UK ( n  = 68), Russia ( n  = 51), and China ( n  = 45) were included in this analysis. Feeding practices were assessed using questionnaires at 3 and 6 months. Maternal attitudes toward infant feeding and infant eating behaviors were measured by Iowa Infant Feeding Attitudes Scale (IIFAS) and Baby Eating Behavior Questionnaire (BEBQ) at 5-6 weeks postpartum; scores were compared between countries and associations with infant feeding at 3 and 6 months were examined.  Results:  IIFAS score was significantly different between countries; mean scores in Chinese and Russian mothers (China 64.6 ± 4.88 and Russia 61.5 ± 6.15) lay in the range of ""neutral breastfeeding attitudes,"" while British mothers had more positive attitudes (70.6 ± 6.47, post hoc  p  < 0.001). Russian infants had higher scores for ""general appetite"" (mean = 4.8 ± 0.41,  p  < 0.05) and ""satiety responsiveness"" (mean = 8.7 ± 1.08,  p  < 0.01) than Chinese or British infants. Longer duration of full-time education was associated with more positive attitudes toward breastfeeding in the whole sample ( p  < 0.001) and in the United Kingdom ( p  < 0.05). The majority of mothers were exclusively breastfeeding (EBF) at 3 months. Total IIFAS and BEBQ scores were not significant predictors of EBF at 3 and 6 months ( p  > 0.05), although greater agreement with the IIFAS statement ""Formula feeding is more convenient than breastfeeding"" was associated with lower EBF at 3 months (OR = 0.47, 95% CI: 0.29-0.78,  p  < 0.01).  Conclusions:  Maternal attitudes toward infant feeding and perceptions of infant eating behavior differed between countries, but were not associated with EBF at 6 months. Mothers with a greater baseline perception that formula feeding is more convenient than breastfeeding were less likely to EBF at 3 months; this could be a potential target for education.",2020,"Total IIFAS and BEBQ scores were not significant predictors of EBF at 3 and 6 months ( p  > 0.05), although greater agreement with the IIFAS statement ""Formula feeding is more convenient than breastfeeding"" was associated with lower EBF at 3 months (OR = 0.47, 95% CI: 0.29-0.78,  p  < 0.01).  ","['164 mothers with healthy term infants recruited for a randomized trial comparing breast pumps from the UK ( n \u2009=\u200968), Russia ( n \u2009=\u200951), and China ( n \u2009=\u200945', ""mothers' attitudes toward infant feeding and infant eating behavior in different countries, and their associations with infant feeding at 3 and 6 months""]",[],"['Iowa Infant Feeding Attitudes Scale (IIFAS) and Baby Eating Behavior Questionnaire (BEBQ', 'Longer duration of full-time education', 'positive attitudes toward breastfeeding', 'Maternal Infant-Feeding Attitudes, Infant Eating Behaviors, and Maternal Feeding Choice', 'satiety responsiveness', 'IIFAS score', 'positive attitudes', 'Maternal attitudes toward infant feeding and infant eating behaviors', 'general appetite', 'Total IIFAS and BEBQ scores', 'Maternal attitudes toward infant feeding and perceptions of infant eating behavior']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0182541', 'cui_str': 'Breast pump'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],"[{'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0682295', 'cui_str': 'Full-time employment'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",164.0,0.0418655,"Total IIFAS and BEBQ scores were not significant predictors of EBF at 3 and 6 months ( p  > 0.05), although greater agreement with the IIFAS statement ""Formula feeding is more convenient than breastfeeding"" was associated with lower EBF at 3 months (OR = 0.47, 95% CI: 0.29-0.78,  p  < 0.01).  ","[{'ForeName': 'Jinyue', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Childhood Nutrition Research, Population Policy and Practice Research and Teaching Department, UCL Great Ormond Street Institute of Child Health, London, United Kingdom.'}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': ""Beijing Children's Hospital Affiliated to Capital Medical University, Beijing, China.""}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Lukoyanova', 'Affiliation': 'Department of Nutrition for Sick and Healthy Children, ""National Medical Research Center of Children\'s Health"" of the Ministry of Health of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Borovik', 'Affiliation': 'Department of Nutrition for Sick and Healthy Children, ""National Medical Research Center of Children\'s Health"" of the Ministry of Health of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'Mary S', 'Initials': 'MS', 'LastName': 'Fewtrell', 'Affiliation': 'Childhood Nutrition Research, Population Policy and Practice Research and Teaching Department, UCL Great Ormond Street Institute of Child Health, London, United Kingdom.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2020.0066']
1266,32599652,"Single-Dose Pharmacokinetics and Pharmacodynamics of Transthyretin Targeting N-acetylgalactosamine-Small Interfering Ribonucleic Acid Conjugate, Vutrisiran, in Healthy Subjects.","Vutrisiran (ALN-TTRsc02) is a liver-directed, investigational, small interfering ribonucleic acid drug for the treatment of transthyretin (TTR)-mediated amyloidosis. This phase I, randomized, single-blind, placebo-controlled, single ascending dose study evaluated the pharmacodynamics, pharmacokinetics, and safety profile of subcutaneously administered vutrisiran (5-300 mg) in healthy subjects (n = 80). Vutrisiran treatment achieved potent and sustained TTR reduction in a dose-dependent manner, with mean maximum TTR reduction of 57-97%, maintained for ≥ 90 days post dose. Vutrisiran was rapidly absorbed (peak plasma concentration 3-5 hours post dose), had a short plasma half-life (4.2-7.5 hours), and plasma concentrations increased in a dose-proportional manner. Pharmacodynamic and pharmacokinetic results were similar in Japanese and non-Japanese subjects. Vutrisiran had an acceptable safety profile; the most common treatment-related adverse event was mild, transient injection site reactions in four (6.7%) vutrisiran-treated subjects. The favorable pharmacokinetic, pharmacodynamic, and safety results observed here support vutrisiran's continued clinical development.",2020,"Vutrisiran had an acceptable safety profile; the most common treatment-related adverse event was mild, transient injection site reactions in four (6.7%) vutrisiran-treated subjects.","['healthy subjects (n = 80', 'Japanese and non-Japanese subjects', 'Healthy Subjects']","['subcutaneously-administered vutrisiran', 'placebo']","['mean maximum TTR reduction', 'potent and sustained TTR reduction', 'plasma concentrations', 'pharmacodynamics, pharmacokinetics, and safety profile']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.034292,"Vutrisiran had an acceptable safety profile; the most common treatment-related adverse event was mild, transient injection site reactions in four (6.7%) vutrisiran-treated subjects.","[{'ForeName': 'Bahru A', 'Initials': 'BA', 'LastName': 'Habtemariam', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Karsten', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Husain', 'Initials': 'H', 'LastName': 'Attarwala', 'Affiliation': 'Moderna Therapeutics, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Goel', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Melch', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Clausen', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Pushkal', 'Initials': 'P', 'LastName': 'Garg', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Akshay K', 'Initials': 'AK', 'LastName': 'Vaishnaw', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Marianne T', 'Initials': 'MT', 'LastName': 'Sweetser', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Gabriel J', 'Initials': 'GJ', 'LastName': 'Robbie', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, Massachusetts, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vest', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, Massachusetts, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1974']
1267,32603494,Similar safety and efficacy in previously treated adults with growth hormone deficiency randomized to once-weekly somapacitan or daily growth hormone.,"OBJECTIVE


Somapacitan is a long-acting, reversible albumin-binding growth hormone (GH) derivative in development. This study aimed to evaluate the safety and efficacy of once-weekly somapacitan versus daily GH over 52 weeks in Japanese patients with adult growth hormone deficiency (AGHD).
DESIGN


Phase 3, multicentre, randomized, parallel-group, open-label, active-controlled trial (NCT03075644).
PATIENTS


Previously GH-treated Japanese patients with AGHD were randomized 3:1 to somapacitan (n = 46) or daily GH (n = 16) for 20 weeks' dose titration and 32 weeks' fixed-dose treatment.
MEASUREMENTS


Primary endpoint was the incidence of adverse events (AEs). Secondary endpoints included change from baseline to week 52 in visceral, subcutaneous and total adipose tissue (VAT, SAT and TAT).
RESULTS


Mean (SD) prescribed doses after titration were 1.780 (1.058) mg/week for somapacitan and 0.197 (0.083) mg/day for daily GH. Rate of AEs per 100 patient-years was similar between arms (somapacitan, 312.7; daily GH, 309.8). Four AEs in the somapacitan arm were serious; none were considered treatment-related. Mean insulin-like growth factor-I standard deviation score (IGF-I SDS) was maintained from baseline in both arms. No significant differences were observed between arms for change from baseline to week 52 in VAT, SAT or TAT (estimated difference, somapacitan - daily GH [95% CI]: -1.74 [-18.13; 14.66], -11.53 [-35.54; 12.48] and - 12.85 [-47.31; 21.62] cm 2  , respectively).
CONCLUSIONS


Treatment in both groups was well tolerated, with no unexpected safety findings. Impact on adipose tissue was similar to somapacitan and daily GH in patients with AGHD. A short visual summary of our work is available at https://bit.ly/3946YNF.",2020,"No significant differences were observed between arms for change from baseline to week 52 in VAT, SAT or TAT (estimated difference, somapacitan - daily GH [95% CI]:","['Patients Previously GH-treated Japanese patients with AGHD', 'Japanese patients with adult growth hormone deficiency (AGHD', 'previously treated adults with growth hormone deficiency', 'patients with AGHD', '21.62']","['once-weekly somapacitan versus daily GH', 'somapacitan or daily growth hormone', 'daily GH', 'somapacitan']","['I standard deviation score (IGF-I SDS', 'VAT, SAT or TAT', 'adipose tissue', 'change from baseline to week\xa052 in visceral, subcutaneous and total adipose tissue (VAT, SAT and TAT', 'safety and efficacy', 'incidence of adverse events (AEs', 'Mean insulin-like growth factor']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C1720505', 'cui_str': 'Adult growth hormone deficiency'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271561', 'cui_str': 'Growth hormone deficiency'}]","[{'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}]","[{'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0042427', 'cui_str': 'Vatican City'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0017375', 'cui_str': 'TAT gene'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}]",,0.297851,"No significant differences were observed between arms for change from baseline to week 52 in VAT, SAT or TAT (estimated difference, somapacitan - daily GH [95% CI]:","[{'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Otsuka', 'Affiliation': 'Department of General Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Tahara', 'Affiliation': 'Department of Neurosurgery, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Ogawa', 'Affiliation': 'CMR Development Division, Novo Nordisk Pharma Ltd., Tokyo, Japan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Højby Rasmussen', 'Affiliation': 'Global Development, Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Takano', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, Kitasato University, Sagamihara, Japan.'}]",Clinical endocrinology,['10.1111/cen.14273']
1268,32607574,Relationship Between Intensive Care Unit Delirium Severity and 2-Year Mortality and Health Care Utilization.,"BACKGROUND


Critical care patients with delirium are at an increased risk of functional decline and mortality long term.
OBJECTIVE


To determine the relationship between delirium severity in the intensive care unit and mortality and acute health care utilization within 2 years after hospital discharge.
METHODS


A secondary data analysis of the Pharmacological Management of Delirium and Deprescribe randomized controlled trials. Patients were assessed twice daily for delirium or coma using the Richmond Agitation-Sedation Scale and the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Delirium severity was measured using the CAM-ICU-7. Mean delirium severity (from time of randomization to discharge) was categorized as rapidly resolving, mild to moderate, or severe. Cox proportional hazards regression was used to model time to death, first emergency department visit, and rehospitalization. Analyses were adjusted for age, sex, race, Charlson Comorbidity Index, Acute Physiology and Chronic Health Evaluation II score, discharge location, diagnosis, and intensive care unit type.
RESULTS


Of 434 patients, those with severe delirium had higher mortality risk than those with rapidly resolving delirium (hazard ratio 2.21; 95% CI, 1.35-3.61). Those with 5 or more days of delirium or coma had higher mortality risk than those with less than 5 days (hazard ratio 1.52; 95% CI, 1.07-2.17). Delirium severity and number of days of delirium or coma were not associated with time to emergency department visits and rehospitalizations.
CONCLUSION


Increased delirium severity and days of delirium or coma are associated with higher mortality risk 2 years after discharge.",2020,"Delirium severity and number of days of delirium or coma were not associated with time to emergency department visits and rehospitalizations.
",[],[],"['mortality risk', 'Mean delirium severity', 'Delirium severity and number of days of delirium or coma', 'Delirium severity', 'delirium or coma using the Richmond Agitation-Sedation Scale']",[],[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}]",434.0,0.192125,"Delirium severity and number of days of delirium or coma were not associated with time to emergency department visits and rehospitalizations.
","[{'ForeName': 'Patricia S', 'Initials': 'PS', 'LastName': 'Andrews', 'Affiliation': 'About the Authors: Patricia S. Andrews is an assistant professor, Department of Psychiatry and Behavioral Sciences, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Sophia Wang is an assistant professor, Department of Psychiatry, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Perkins', 'Affiliation': 'Anthony J. Perkins is a staff biostatistician, Department of Biostatistics, Indiana University School of Medicine.'}, {'ForeName': 'Sujuan', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Sujuan Gao is a professor, Department of Biostatistics, Indiana University School of Medicine.'}, {'ForeName': 'Sikandar', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Sikandar Khan is an assistant professor, Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Department of Medicine, Indiana University School of Medicine; and a research scientist, Indiana University Center for Aging Research, Regenstrief Institute, Indianapolis, Indiana.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Lindroth', 'Affiliation': 'Heidi Lindroth is a postdoctoral fellow, Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Department of Medicine, Indiana University School of Medicine; and an affiliate at the Indiana University Center for Aging Research, Regenstrief Institute.'}, {'ForeName': 'Malaz', 'Initials': 'M', 'LastName': 'Boustani', 'Affiliation': 'Malaz Boustani is a professor, Department of Medicine, Indiana University School of Medicine; the founding director, Center for Health Innovation and Implementation Science at Indiana Clinical Translational Science Institute; director of senior care innovation, Eskenazi Hospital; and a research scientist, Indiana University Center for Aging Research, Regen strief Institute.'}, {'ForeName': 'Babar', 'Initials': 'B', 'LastName': 'Khan', 'Affiliation': 'Babar Khan is an associate professor, Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Department of Medicine, Indiana University School of Medicine; and a research scientist, Indiana University Center for Aging Research, Regenstrief Institute.'}]","American journal of critical care : an official publication, American Association of Critical-Care Nurses",['10.4037/ajcc2020498']
1269,32474710,Ultrasound-guided pudendal nerve block in patients undergoing open hemorrhoidectomy: a double-blind randomized controlled trial.,"PURPOSE


In this double-blind randomized trial, we aimed to compare the postoperative pain, complications, and length of hospital stay in patients undergoing open hemorrhoidectomy under spinal anesthesia with or without the pudendal nerve block.
METHODS


Patients undergoing Milligan-Morgan hemorrhoidectomy under spinal anesthesia were randomized to undergo a pudendal nerve block or no intervention. Postoperative pain on the visual analogue scale (VAS) at 6, 12, 24, and 48 h; opioid administration; and length of hospital stay were recorded and analyzed.
RESULTS


Over the study period, 49 patients were included and 23 randomized in the treatment arm. No differences in terms of age, gender, and preoperative risk factors were noted between groups. The pain on the VAS at 6, 12, 24, and 48 h was 2.8 vs. 4.6 (p = 0.046), 3.4 vs. 4.7 (p = 0.697), 1.4 vs. 3.1 (p = 0.016), and 1.0 vs. 2.1 (p = 0.288) in the treatment and control groups respectively. No differences in opioids use or complications were noted. Length of hospital stay was 1.2 vs. 1.8 days respectively (p = 0.046). No complications directly associated to the pudendal nerve block were observed. Multivariate analysis revealed that the pudendal nerve block was an independent factor reducing the postoperative pain.
CONCLUSIONS


The ultrasound-guided pudendal nerve block in patients undergoing open hemorrhoidectomy under spinal anesthesia showed a statistically significant reduction in postoperative pain and length of hospital stay. The proposed technique appeared to be safe and feasible and may be recommendable in patients undergoing open hemorrhoidectomy.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04251884.",2020,Length of hospital stay was 1.2 vs. 1.8 days respectively (p = 0.046).,"['patients undergoing open hemorrhoidectomy', 'patients undergoing open', 'Patients undergoing Milligan-Morgan hemorrhoidectomy under spinal anesthesia', '49 patients were included and 23 randomized in the treatment arm', 'patients undergoing open hemorrhoidectomy under spinal anesthesia', 'patients undergoing open hemorrhoidectomy under spinal anesthesia with or without the pudendal nerve block']","['Ultrasound-guided pudendal nerve block', 'pudendal nerve block or no intervention', 'hemorrhoidectomy']","['pain on the VAS', 'postoperative pain', 'Length of hospital stay', 'length of hospital stay', 'opioids use or complications', 'postoperative pain, complications, and length of hospital stay', 'pudendal nerve block', 'postoperative pain and length of hospital stay', 'Postoperative pain on the visual analogue scale (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0473074', 'cui_str': 'Open hemorrhoidectomy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0582521', 'cui_str': 'Morgan'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0394776', 'cui_str': 'Injection of anesthetic agent into pudendal nerve'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394776', 'cui_str': 'Injection of anesthetic agent into pudendal nerve'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0394776', 'cui_str': 'Injection of anesthetic agent into pudendal nerve'}]",49.0,0.227957,Length of hospital stay was 1.2 vs. 1.8 days respectively (p = 0.046).,"[{'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Di Giuseppe', 'Affiliation': 'Surgery, Ospedale Regionale di Bellinzona e Valli, Bellinzona, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Saporito', 'Affiliation': 'Anesthesiology, Ospedale Regionale di Bellinzona e Valli, Bellinzona, Switzerland.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'La Regina', 'Affiliation': 'Surgery, Ospedale Regionale di Bellinzona e Valli, Bellinzona, Switzerland.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Tasciotti', 'Affiliation': 'Anesthesiology, Ospedale Regionale di Bellinzona e Valli, Bellinzona, Switzerland.'}, {'ForeName': 'Enea', 'Initials': 'E', 'LastName': 'Ghielmini', 'Affiliation': 'Surgery, University Hospital of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Vannelli', 'Affiliation': 'Surgery, Ospedale Valduce, Como, Italy.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Pini', 'Affiliation': 'Surgery, Ospedale Regionale di Bellinzona e Valli, Bellinzona, Switzerland.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Mongelli', 'Affiliation': 'Surgery, Ospedale Regionale di Lugano, 6900, Lugano, Switzerland. francesco.mongelli@mail.com.'}]",International journal of colorectal disease,['10.1007/s00384-020-03630-x']
1270,32476162,"Eflapegrastim, a Long-Acting Granulocyte-Colony Stimulating Factor for the Management of Chemotherapy-Induced Neutropenia: Results of a Phase III Trial.","BACKGROUND


Eflapegrastim, a novel, long-acting recombinant human granulocyte-colony stimulating factor (rhG-CSF), consists of a rhG-CSF analog conjugated to a human IgG4 Fc fragment via a short polyethylene glycol linker. Preclinical and phase I and II pharmacodynamic and pharmacokinetic data showed increased potency for neutrophil counts for eflapegrastim versus pegfilgrastim. This open-label phase III trial compared the efficacy and safety of eflapegrastim with pegfilgrastim for reducing the risk of chemotherapy-induced neutropenia.
MATERIALS AND METHODS


Patients with early-stage breast cancer were randomized 1:1 to fixed-dose eflapegrastim 13.2 mg (3.6 mg G-CSF) or standard pegfilgrastim (6 mg G-CSF) following standard docetaxel plus cyclophosphamide chemotherapy for 4 cycles. The primary objective was to demonstrate the noninferiority of eflapegrastim compared with pegfilgrastim in mean duration of severe neutropenia (DSN; grade 4) in cycle 1.
RESULTS


Eligible patients were randomized 1:1 to study arms (eflapegrastim, n = 196; pegfilgrastim, n = 210). The incidence of cycle 1 severe neutropenia was 16% (n = 31) for eflapegrastim versus 24% (n = 51) for pegfilgrastim, reducing the relative risk by 35% (p = .034). The difference in mean cycle 1 DSN (-0.148 day) met the primary endpoint of noninferiority (p < .0001) and also showed statistical superiority for eflapegrastim (p = .013). Noninferiority was maintained for the duration of treatment (all cycles, p < .0001), and secondary efficacy endpoints and safety results were also comparable for study arms.
CONCLUSION


These results demonstrate noninferiority and comparable safety for eflapegrastim at a lower G-CSF dose versus pegfilgrastim. The potential for increased potency of eflapegrastim to deliver improved clinical benefit warrants further clinical study in patients at higher risk for CIN.
IMPLICATIONS FOR PRACTICE


Chemotherapy-induced neutropenia (CIN) remains a significant clinical dilemma for oncology patients who are striving to complete their prescribed chemotherapy regimen. In a randomized, phase III trial comparing eflapegrastim to pegfilgrastim in the prevention of CIN, the efficacy of eflapegrastim was noninferior to pegfilgrastim and had comparable safety. Nevertheless, the risk of CIN remains a great concern for patients undergoing chemotherapy, as the condition frequently results in chemotherapy delays, dose reductions, and treatment discontinuations.",2020,"Noninferiority was maintained for the duration of treatment (all cycles, p < .0001), and secondary efficacy endpoints and safety results were also comparable for study arms.
","['patients at higher risk for CIN', 'oncology patients who are striving to complete their prescribed chemotherapy regimen', 'Patients with early-stage breast cancer', 'Eligible patients']","['pegfilgrastim', 'eflapegrastim 13.2 mg (3.6 mg G-CSF) or standard pegfilgrastim', 'eflapegrastim with pegfilgrastim', 'standard docetaxel plus cyclophosphamide chemotherapy']","['mean cycle 1 DSN', 'incidence of cycle 1 severe neutropenia', 'neutrophil counts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1827687', 'cui_str': 'Chemotherapy-induced neutropenia'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}]",,0.0418564,"Noninferiority was maintained for the duration of treatment (all cycles, p < .0001), and secondary efficacy endpoints and safety results were also comparable for study arms.
","[{'ForeName': 'Lee S', 'Initials': 'LS', 'LastName': 'Schwartzberg', 'Affiliation': 'West Cancer Center, Germantown, Tennessee, USA.'}, {'ForeName': 'Gajanan', 'Initials': 'G', 'LastName': 'Bhat', 'Affiliation': 'Spectrum Pharmaceuticals, Inc., Irvine, California, USA.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Peguero', 'Affiliation': 'Oncology Consultants PA, Houston, Texas, USA.'}, {'ForeName': 'Richy', 'Initials': 'R', 'LastName': 'Agajanian', 'Affiliation': 'The Oncology Institute of Hope and Innovation, Downey, California, USA.'}, {'ForeName': 'Jayaram S', 'Initials': 'JS', 'LastName': 'Bharadwaj', 'Affiliation': 'Pacific Cancer Medical Center, Anaheim, California, USA.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Restrepo', 'Affiliation': 'Texas Oncology PA, McAllen, Texas, USA.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Hlalah', 'Affiliation': 'Bond Clinic PA, Winter Haven, Florida, USA.'}, {'ForeName': 'Inderjit', 'Initials': 'I', 'LastName': 'Mehmi', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Simi Valley, California, USA.'}, {'ForeName': 'Shanta', 'Initials': 'S', 'LastName': 'Chawla', 'Affiliation': 'Spectrum Pharmaceuticals, Inc., Irvine, California, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Hasal', 'Affiliation': 'Spectrum Pharmaceuticals, Inc., Irvine, California, USA.'}, {'ForeName': 'Zane', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Spectrum Pharmaceuticals, Inc., Irvine, California, USA.'}, {'ForeName': 'Patrick Wayne', 'Initials': 'PW', 'LastName': 'Cobb', 'Affiliation': 'St. Vincent Frontier Cancer Center, Billings, Montana, USA.'}]",The oncologist,['10.1634/theoncologist.2020-0105']
1271,32482565,A Plea for Optimizing Selection in Current Adjuvant Immunotherapy Trials for High-risk Nonmetastatic Renal Cell Carcinoma According to Expected Cancer-specific Mortality.,"BACKGROUND


Tyrosine kinase inhibitor-based adjuvant therapy showed no survival benefits for patients with high-risk nonmetastatic renal cell carcinoma (nmRCC). Five randomized immune-oncology checkpoint inhibitor trials are ongoing. We assessed the effect of stage, grade, and histologic type on cancer-specific mortality (CSM) in candidates for 1 of the 4 North American ongoing immune-oncology checkpoint inhibitor trials of high-risk nmRCC.
PATIENTS AND METHODS


From the Surveillance, Epidemiology, and End Results database (2001-2015), we identified patients who had undergone surgery for nmRCC and had met the inclusion criteria for the PROSPER RCC (nivolumab in treating patients with localized kidney cancer undergoing nephrectomy), CheckMate 914 (a study comparing the combination of nivolumab and ipilimumab versus placebo in participants with localized renal cell carcinoma), KEYNOTE-564 [safety and efficacy study of pembrolizumab (MK-3475) as monotherapy in the adjuvant treatment of renal cell carcinoma post nephrectomy], or IMmotion010 [a study of atezolizumab as adjuvant therapy in participants with renal cell carcinoma (RCC) at high risk of developing metastasis following nephrectomy] trials. Kaplan-Meier and multivariable Cox regression models were used to assess the 10-year CSM rates in the overall cohort according to stage, grade, and histologic characteristics, and in 4 generated random samples according to the eligible patients for each of the 4 trials.
RESULTS


Of 116,750 patients who had undergone surgery for nmRCC, 18,559 (15.9%) had fulfilled the inclusion criteria for 1 of the 4 trials. The greatest proportion of higher stage and grade combinations and sarcomatoid histologic features would have qualified for IMmotion010, followed by KEYNOTE-564, CheckMate 914, and PROSPER RCC. Multivariable Cox regression models demonstrated the most unfavorable prognosis for stage N1 grade 3/4 (hazard ratio [HR], 11.5; P < .001), stage T4N0 grade 3/4 (HR, 9.8; P < .001), and sarcomatoid histologic features (HR, 5.5; P < .001). Among the 4 random samples, the difference in the qualifying criteria resulted in the greatest versus progressively lower CSM rates in the IMmotion010, KEYNOTE-564, CheckMate 914, and PROSPER RCC trials, respectively (P < .001).
CONCLUSIONS


Our findings indicate that participation in adjuvant immunotherapy trials should be predominantly encouraged for patients with high-grade stage T3, T4, and N1 and patients with any stage with sarcomatoid pathologic features.",2020,"Among the 4 random samples, the difference in the qualifying criteria resulted in the greatest versus progressively lower CSM rates in the IMmotion010, KEYNOTE-564, CheckMate 914, and PROSPER RCC trials, respectively (P < .001).
","['patients with localized kidney cancer undergoing', 'High-risk Nonmetastatic Renal Cell Carcinoma', '116,750 patients who had undergone surgery for nmRCC, 18,559 (15.9%) had fulfilled the inclusion criteria for 1 of the 4 trials', 'participants with localized renal cell carcinoma', 'patients with high-grade stage T3, T4, and N1 and patients with any stage with sarcomatoid pathologic features', 'From the Surveillance, Epidemiology, and End Results database (2001-2015', 'patients who had undergone surgery for nmRCC and had met the inclusion criteria for the PROSPER RCC', 'renal cell carcinoma post nephrectomy', 'participants with renal cell carcinoma (RCC) at high risk of developing metastasis following nephrectomy] trials', 'patients with high-risk nonmetastatic renal cell carcinoma (nmRCC']","['Tyrosine kinase inhibitor-based adjuvant therapy', 'pembrolizumab (MK-3475', 'atezolizumab', 'nephrectomy', 'nivolumab and ipilimumab versus placebo']","['10-year CSM rates', 'sarcomatoid histologic features', 'survival benefits', 'cancer-specific mortality (CSM', 'CSM rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0740457', 'cui_str': 'Malignant tumor of kidney'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0475374', 'cui_str': 'T3 category'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0027695', 'cui_str': 'Kidney excision'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C3660977', 'cui_str': 'MK-3475'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0027695', 'cui_str': 'Kidney excision'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",116750.0,0.234096,"Among the 4 random samples, the difference in the qualifying criteria resulted in the greatest versus progressively lower CSM rates in the IMmotion010, KEYNOTE-564, CheckMate 914, and PROSPER RCC trials, respectively (P < .001).
","[{'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Palumbo', 'Affiliation': 'Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Center, Montreal, QC, Canada; Urology Unit, ASST Spedali Civili of Brescia, Department of Medical and Surgical Specialties, Radiological Science and Public Health, University of Brescia, Brescia, Italy. Electronic address: palumbo.carlotta@gmail.com.'}, {'ForeName': 'Elio', 'Initials': 'E', 'LastName': 'Mazzone', 'Affiliation': 'Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Center, Montreal, QC, Canada; Division of Experimental Oncology, Unit of Urology, Urological Research Institute, IRCCS San Raffaele Scientific Institute, and Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Francesco A', 'Initials': 'FA', 'LastName': 'Mistretta', 'Affiliation': 'Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Center, Montreal, QC, Canada; Department of Urology, European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Knipper', 'Affiliation': 'Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Center, Montreal, QC, Canada; Martini Klinik, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Perrotte', 'Affiliation': 'Division of Urology, University of Montreal Hospital Center, Montreal, QC, Canada.'}, {'ForeName': 'Shahrokh F', 'Initials': 'SF', 'LastName': 'Shariat', 'Affiliation': 'Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Department of Urology, Weill Cornell Medical College, New York, NY; Department of Urology, University of Texas Southwestern Medical School, Dallas, TX; Department of Urology, Second Faculty of Medicine, Charles University, Prague, Czech Republic; Institute for Urology and Reproductive Health, I.M. Sechenov First Moscow State Medical University, Moscow, Russia.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': 'Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Center, Montreal, QC, Canada; Division of Urology, University of Montreal Hospital Center, Montreal, QC, Canada.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Kapoor', 'Affiliation': 'Division of Urology, Department of Surgery, Juravinski Cancer Centre, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Lattouf', 'Affiliation': 'Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Center, Montreal, QC, Canada; Department of Surgery, Université de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Simeone', 'Affiliation': 'Urology Unit, ASST Spedali Civili of Brescia, Department of Medical and Surgical Specialties, Radiological Science and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Briganti', 'Affiliation': 'Division of Experimental Oncology, Unit of Urology, Urological Research Institute, IRCCS San Raffaele Scientific Institute, and Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Antonelli', 'Affiliation': 'Urology Unit, ASST Spedali Civili of Brescia, Department of Medical and Surgical Specialties, Radiological Science and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Pierre I', 'Initials': 'PI', 'LastName': 'Karakiewicz', 'Affiliation': 'Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Center, Montreal, QC, Canada; Division of Urology, University of Montreal Hospital Center, Montreal, QC, Canada.'}]",Clinical genitourinary cancer,['10.1016/j.clgc.2019.11.010']
1272,32484441,Facebook as a Novel Tool for Continuous Professional Education on Dementia: Pilot Randomized Controlled Trial.,"BACKGROUND


Social network sites (SNSs) are widely exploited in health education and communication by the general public, including patients with various conditions. Nevertheless, there is an absence of evidence evaluating SNSs in connecting health professionals for professional purposes.
OBJECTIVE


This pilot randomized controlled trial was designed to evaluate the feasibility of an intervention aiming to investigate the effects of a continuous professional education program utilizing Facebook to obtain knowledge on dementia and care for patients with dementia.
METHODS


Eighty health professionals from Hong Kong were recruited for participation in the study and randomized at a 1:1 ratio by a block randomization method to the intervention group (n=40) and control group (n=40). The intervention was an 8-week educational program developed to deliver updated knowledge on dementia care from a multidisciplinary perspective, either by Facebook (intervention group) or by email (control group) from October 2018 to January 2019. The primary outcomes were the effects of the intervention, measured by differences in the means of changes in pre- and postintervention scores of knowledge assessments from the 25-item Dementia Knowledge Assessment Scale (DKAS) and formative evaluation of 20 multiple choice questions. Other outcome measurements included participant compliance, participant engagement in Facebook, satisfaction, and self-perceived uses of Facebook for continuing professional education programs.
RESULTS


Significantly more intervention group participants (n=35) completed the study than the control group (n=25) (P<.001). The overall retention rate was 75% (60/80). The mean of changes in scores in the intervention group were significant in all assessments (P<.001). A significant difference in the mean of changes in scores between the two groups was identified in the DKAS subscale Communication and Behavior (95% CI 0.4-3.3, P=.02). There was no significant difference in the total DKAS scores, scores of other DKAS subscales, and multiple choice questions. Participant compliance was significantly higher in the intervention group than in the control group (P<.001). The mean numbers of participants accessing the learning materials were 31.5 (SD 3.9) and 17.6 (SD 5.2) in the intervention and control group, respectively. Polls attracted the highest level of participant engagement, followed by videos. Intervention group participants scored significantly higher in favoring the use of Facebook for the continuing education program (P=.03). Overall, participants were satisfied with the interventions (mean score 4 of a total of 5, SD 0.6).
CONCLUSIONS


The significantly higher retention rate, together with the high levels of participant compliance and engagement, demonstrate that Facebook is a promising tool for professional education. Education delivered through Facebook was significantly more effective at improving participants' knowledge of how people with dementia communicate and behave. Participants demonstrated positive attitudes toward utilizing Facebook for professional learning. These findings provide evidence for the feasibility of using Facebook as an intervention delivery tool in a manner that can be rolled out into practical settings.",2020,Intervention group participants scored significantly higher in favoring the use of Facebook for the continuing education program (P=.03).,"['Eighty health professionals from Hong Kong were recruited for participation in the study and randomized at a 1:1 ratio by a block randomization method to the intervention group (n=40) and control group (n=40', 'patients with dementia', 'Continuous Professional Education on Dementia', 'patients with various conditions']","['8-week educational program developed to deliver updated knowledge on dementia care from a multidisciplinary perspective, either by Facebook (intervention group) or by email (control group', 'continuous professional education program utilizing Facebook', 'Facebook']","['total DKAS scores, scores of other DKAS subscales, and multiple choice questions', 'mean numbers of participants accessing the learning materials', 'mean of changes in scores', 'means of changes in pre- and postintervention scores of knowledge assessments from the 25-item Dementia Knowledge Assessment Scale (DKAS) and formative evaluation of 20 multiple choice questions', 'participant compliance, participant engagement in Facebook, satisfaction, and self-perceived uses of Facebook for continuing professional education programs', 'DKAS subscale Communication and Behavior', 'overall retention rate', 'Participant compliance']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013647', 'cui_str': 'Professional Education'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013647', 'cui_str': 'Professional Education'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013647', 'cui_str': 'Professional Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.081195,Intervention group participants scored significantly higher in favoring the use of Facebook for the continuing education program (P=.03).,"[{'ForeName': 'Windy Sy', 'Initials': 'WS', 'LastName': 'Chan', 'Affiliation': 'School of Health Sciences, Caritas Institute of Higher Education, New Territories, China (Hong Kong).'}, {'ForeName': 'Angela Ym', 'Initials': 'AY', 'LastName': 'Leung', 'Affiliation': 'Centre for Gerontological Nursing, School of Nursing, The Hong Kong Polytechnic University, Kowloon, China (Hong Kong).'}]",Journal of medical Internet research,['10.2196/16772']
1273,32479559,Effects of singing bowl exposure on Karolinska sleepiness scale and pupillographic sleepiness test: A randomised crossover study.,"BACKGROUND


The aim of this study was to investigate the effects on subjective and objective sleepiness of a stay above a large struck singing bowl compared to a relaxation period in a silent singing bowl.
METHODS


Fifty-eight healthy subjects were recruited for the study, 48 participated on two days, one week apart, during the same timeslot. The Karolinska sleepiness scale was used to evaluate current subjective sleepiness, and the relative pupillary unrest index to assess objective sleepiness. In this randomized cross-over study, the intervention consisted of a 20-minute stay in a hammock while the singing bowl, positioned beneath, was struck seven times. The controlled comparator was a 20-minute stay in the same hammock above the singing bowl, but without being struck. After these two interventions subjective and objective sleepiness were re-evaluated.
RESULTS


The mean relative pupillary unrest index values after relaxation in the struck and silent singing bowl groups were 0.74 and respectively 0.71 (p = 0.460). The median Karolinska sleepiness scale value after relaxation with the struck singing bowl was 3 compared with 4 (p = 0.041) for the silent singing bowl.
DISCUSSION


This study evaluated the influence of a struck singing bowl on sleepiness during daytime. Subjective sleepiness was significantly lower after relaxation above a struck singing bowl. After gender stratification, the difference was still significant in women. Objective sleepiness was not different in both groups. Finally, we can only speculate if women may be more susceptible to subjective improvements in case of sleepiness and show another perception of relaxation in a struck singing bowl compared to men.",2020,The mean relative pupillary unrest index values after relaxation in the struck and silent singing bowl groups were 0.74 and respectively 0.71,"['Fifty-eight healthy subjects were recruited for the study, 48 participated on two days, one week apart, during the same timeslot']","['singing bowl exposure', 'struck singing bowl']","['Karolinska sleepiness scale', 'mean relative pupillary unrest index values', 'Karolinska sleepiness scale and pupillographic sleepiness test', 'Objective sleepiness', 'Subjective sleepiness', 'median Karolinska sleepiness scale value']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1442452', 'cui_str': 'One week'}]","[{'cui': 'C0234857', 'cui_str': 'Singing'}, {'cui': 'C0336949', 'cui_str': 'Bowling'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0038452', 'cui_str': 'Employee Strikes'}]","[{'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0858854', 'cui_str': 'Unrest'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",58.0,0.0151798,The mean relative pupillary unrest index values after relaxation in the struck and silent singing bowl groups were 0.74 and respectively 0.71,"[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Bergmann', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Riedinger', 'Affiliation': 'Department of Therapeutic Radiology and Oncology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Ambra', 'Initials': 'A', 'LastName': 'Stefani', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mitterling', 'Affiliation': 'Department of Neurology 1, Kepler University Hospital, Linz, Austria.'}, {'ForeName': 'Evi', 'Initials': 'E', 'LastName': 'Holzknecht', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Grassmayr', 'Affiliation': 'Bell Foundry Grassmayr, Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Högl', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}]",PloS one,['10.1371/journal.pone.0233982']
1274,32488332,Effect of a rabeprazole half-dose twice daily on acid inhibition in patients with different CYP2C19 alleles.,"PURPOSE


Fractional doses of proton pump inhibitors (PPIs) more often than once daily (qd) inhibit 24-h acid secretion more effectively than an increase in the standard single daily dose. Although rabeprazole 5 mg qd is covered for prevention of aspirin-induced gastric injury under the Japanese insurance system, it is unclear whether rabeprazole 5 mg twice daily (bid) would more effectively inhibit acid secretion. We compared acid inhibition between rabeprazole 10 mg qd and 5 mg bid in healthy volunteers with different alleles of CYP2C19.
METHODS


Twelve Helicobacter pylori-negative healthy volunteers (CYP2C19 genotypes: extensive metabolizer (EM) (n = 6) and poor metabolizer (PM) (n = 6)) received three kinds of regimen for 7 days under a randomized crossover design: rabeprazole 5 mg qd (5 mg QD), 10 mg qd (10 mg QD), and 5 mg bid (5 mg BID). A 24-hour pH monitoring was conducted before the trial and on day 7 of each regimen.
RESULTS


No significant differences in median pH values (4.0 (1.9-5.9)) and (4.4 (2.1-6.5)) or percent time of pH ≥ 4 (50.7% (11.9-86.8%) and 56.8% (19.3-83.9%)) were seen between the 10 mg QD and 5 mg BID regimens. Median pHs and percent time of pH ≥ 4 in CYP2C19 PMs were significantly higher than those in EMs. With 5 mg BID, there was no significant difference in percent-time with pH ≥ 4 between daytime and nighttime, but the 10 mg QD showed a significant difference.
CONCLUSION


Rabeprazole 5 mg bid provided no therapeutic advantage for acid inhibition compared with rabeprazole 10 mg qd, regardless of CYP2C19 genotype status.",2020,"CONCLUSION


Rabeprazole 5 mg bid provided no therapeutic advantage for acid inhibition compared with rabeprazole 10 mg qd, regardless of CYP2C19 genotype status.","['healthy volunteers with different alleles of CYP2C19', 'patients with different CYP2C19 alleles', 'Twelve Helicobacter pylori-negative healthy volunteers (CYP2C19 genotypes: extensive metabolizer (EM) (n = 6) and poor metabolizer (PM) (n = 6']","['proton pump inhibitors (PPIs', 'rabeprazole', 'Rabeprazole']","['percent-time with pH ≥ 4 between daytime and nighttime', 'median pH values', 'Median pHs and percent time of pH ≥ 4 in CYP2C19 PMs']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]","[{'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0378482', 'cui_str': 'rabeprazole'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0033046', 'cui_str': 'Premenstrual syndrome'}]",12.0,0.0294771,"CONCLUSION


Rabeprazole 5 mg bid provided no therapeutic advantage for acid inhibition compared with rabeprazole 10 mg qd, regardless of CYP2C19 genotype status.","[{'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Murata', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization, Kyoto Medical Center, Kyoto, 612-8555, Japan.'}, {'ForeName': 'Mitsushige', 'Initials': 'M', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Gastroenterological Endoscopy, Tokyo Medical University Hospital, 6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan. sugimo@tokyo-med.ac.jp.'}]",European journal of clinical pharmacology,['10.1007/s00228-020-02917-w']
1275,32488368,Footprint preparation with nanofractures in a supraspinatus repair cuts in half the retear rate at 1-year follow-up. A randomized controlled trial.,"PURPOSE


To evaluate if adding nanofractures to the footprint of a supraspinatus tear repair would have any effect in the outcomes at one-year follow-up.
METHODS


Multicentric, triple-blinded, randomized trial with 12-months follow-up. Subjects with isolated symptomatic reparable supraspinatus tears smaller than 3 cm and without grade 4 fatty infiltration were included. These were randomized to two groups: In the Control group an arthroscopic supraspinatus repair was performed; in the Nanofracture group the footprint was additionally prepared with nanofractures (1 mm wide, 9 mm deep microfractures). Clinical evaluation was done with Constant score, EQ-5D-3L, and Brief Pain Inventory. The primary outcome was the retear rate in MRI at 12-months follow-up. Secondary outcomes were: characteristics of the retear (at the footprint or at the musculotendinous junction) and clinical outcomes.
RESULTS


Seventy-one subjects were randomized. Two were lost to follow-up, leaving 69 participants available for assessment at 12-months follow-up (33 in the Control group and 36 in the Nanofracture Group). The Nanofracture group had lower retear rates than the Control group (7/36 [19.4%] vs 14/33 [42.4%], differences significant, p = 0.038). Retear rates at the musculotendinous junction were similar but the Nanofracture group had better tendon healing rates to the bone (34/36 [94.4%] vs. 24/33 [66.71%], p = 0.014). Clinically both groups had significant improvements, but no differences were found between groups.
CONCLUSION


Adding nanofractures at the footprint during an isolated supraspinatus repair lowers in half the retear rate at 12-months follow-up. This is due to improved healing at the footprint.
LEVEL OF EVIDENCE


Level I.",2020,"Retear rates at the musculotendinous junction were similar but the Nanofracture group had better tendon healing rates to the bone (34/36 [94.4%] vs. 24/33 [66.71%], p = 0.014).","['Subjects with isolated symptomatic reparable supraspinatus tears smaller than 3\xa0cm and without grade 4 fatty infiltration were included', 'Seventy-one subjects were randomized']",['arthroscopic supraspinatus repair'],"['tendon healing rates', 'characteristics of the retear (at the footprint or at the musculotendinous junction) and clinical outcomes', 'retear rates', 'retear rate in MRI', 'Constant score, EQ-5D-3L, and Brief Pain Inventory']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0439059', 'cui_str': 'Supraspinatus tear'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0333575', 'cui_str': 'Fatty infiltration'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0450389', 'cui_str': '71'}]","[{'cui': 'C0584869', 'cui_str': 'Supraspinatus muscle structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0584646', 'cui_str': 'Musculotendinous junction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",71.0,0.122116,"Retear rates at the musculotendinous junction were similar but the Nanofracture group had better tendon healing rates to the bone (34/36 [94.4%] vs. 24/33 [66.71%], p = 0.014).","[{'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Ruiz Ibán', 'Affiliation': 'Unidad de Hombro y Codo, Hospital Universitario Ramón y Cajal, Cta Colmenar km 9,100, 28046, Madrid, Spain. drmri@hotmail.com.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Sanchez Alepuz', 'Affiliation': 'Hospital IMED Valencia, Valencia, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Diaz Heredia', 'Affiliation': 'Unidad de Hombro y Codo, Hospital Universitario Ramón y Cajal, Cta Colmenar km 9,100, 28046, Madrid, Spain.'}, {'ForeName': 'Abdul-Ilah', 'Initials': 'AI', 'LastName': 'Hachem', 'Affiliation': 'Head of the Shoulder Unit, Hospital Universitario de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Ezagüi Bentolila', 'Affiliation': 'Hospital Egarsat, Barcelona, Spain.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Calvo', 'Affiliation': 'Arthrosport, Zaragoza, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Verdú', 'Affiliation': 'Unidad de Hombro y Codo, Hospital General Universitario de Elche, Elche, Alicante, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'de Rus Aznar', 'Affiliation': 'Unidad de Hombro y Codo, Hospital Universitario Ramón y Cajal, Cta Colmenar km 9,100, 28046, Madrid, Spain.'}, {'ForeName': 'Francesc', 'Initials': 'F', 'LastName': 'Soler Romagosa', 'Affiliation': 'Traumadvance, Terrassa, Barcelona, Spain.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-06073-7']
1276,32490570,Safety and Feasibility of Additional Tumor Debulking to First-Line Palliative Combination Chemotherapy for Patients with Multiorgan Metastatic Colorectal Cancer.,"INTRODUCTION


Local treatment of metastases is frequently performed in patients with multiorgan metastatic colorectal carcinoma (mCRC) analogous to selected patients with oligometastatic disease for whom this is standard of care. The ORCHESTRA trial (NCT01792934) was designed to prospectively evaluate overall survival benefit from tumor debulking in addition to chemotherapy in patients with multiorgan mCRC. Here, we report the preplanned safety and feasibility evaluation after inclusion of the first 100 patients.
METHODS


Patients were eligible if at least 80% tumor debulking was deemed feasible by resection, radiotherapy and/or thermal ablative therapy. In case of clinical benefit after three or four cycles of respectively 5-fluorouracil/leucovorin or capecitabine and oxaliplatin ± bevacizumab patients were randomized to tumor debulking followed by chemotherapy in the intervention arm, or standard treatment with chemotherapy.
RESULTS


Twelve patients dropped out prior to randomization for various reasons. Eighty-eight patients were randomized to the standard (n = 43) or intervention arm (n = 45). No patients withdrew after randomization. Debulking was performed in 82% (n = 37). Two patients had no lesions left to treat, five had progressive disease, and one patient died prior to local treatment. In 15 patients (40%) 21 serious adverse events related to debulking were reported. Postoperative mortality was 2.7% (n = 1). After debulking chemotherapy was resumed in 89% of patients.
CONCLUSION


Tumor debulking is feasible and does not prohibit administration of palliative chemotherapy in the majority of patients with multiorgan mCRC, despite the occurrence of serious adverse events related to local treatment.
IMPLICATIONS FOR PRACTICE


This first prospective randomized trial on tumor debulking in addition to chemotherapy shows that local treatment of metastases is feasible in patients with multiorgan metastatic colorectal cancer and does not prohibit administration of palliative systemic therapy, despite the occurrence of serious adverse events related to local treatment. The trial continues accrual, and overall survival (OS) data and quality of life assessment are collected to determine whether the primary aim of >6 months OS benefit with preserved quality of life will be met. This will support evidence-based decision making in multidisciplinary colorectal cancer care and can be readily implemented in daily practice.",2020,"shows that local treatment of metastases is feasible in patients with multiorgan metastatic colorectal cancer and does not prohibit administration of palliative systemic therapy, despite the occurrence of serious adverse events related to local treatment.","['patients with multiorgan metastatic colorectal cancer', 'Patients were eligible if at least 80% tumor debulking was deemed feasible by resection', 'patients with multiorgan mCRC', '100 patients', 'Eighty-eight patients', 'patients with multiorgan metastatic colorectal carcinoma (mCRC', 'Patients with Multiorgan Metastatic Colorectal Cancer']","['chemotherapy', 'radiotherapy and/or thermal ablative therapy', 'Additional Tumor Debulking to First-Line Palliative Combination Chemotherapy', '5-fluorouracil/leucovorin or capecitabine and oxaliplatin ± bevacizumab']","['overall survival (OS) data and quality of life assessment', 'Postoperative mortality', 'overall survival benefit']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517898', 'cui_str': '88'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",88.0,0.0760622,"shows that local treatment of metastases is feasible in patients with multiorgan metastatic colorectal cancer and does not prohibit administration of palliative systemic therapy, despite the occurrence of serious adverse events related to local treatment.","[{'ForeName': 'Elske C', 'Initials': 'EC', 'LastName': 'Gootjes', 'Affiliation': 'Department of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'van der Stok', 'Affiliation': 'Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Tineke E', 'Initials': 'TE', 'LastName': 'Buffart', 'Affiliation': 'Department of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Bakkerus', 'Affiliation': 'Department of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Mariette', 'Initials': 'M', 'LastName': 'Labots', 'Affiliation': 'Department of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Barbara M', 'Initials': 'BM', 'LastName': 'Zonderhuis', 'Affiliation': 'Department of Surgery, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Jurriaan B', 'Initials': 'JB', 'LastName': 'Tuynman', 'Affiliation': 'Department of Surgery, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Martijn R', 'Initials': 'MR', 'LastName': 'Meijerink', 'Affiliation': 'Department of Radiology and Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Cornelis J A', 'Initials': 'CJA', 'LastName': 'Haasbeek', 'Affiliation': 'Department of Radiotherapy, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Ten Tije', 'Affiliation': 'Department of Medical Oncology, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Jan-Willem B', 'Initials': 'JB', 'LastName': 'de Groot', 'Affiliation': 'Department of Medical Oncology, Isala, The Netherlands.'}, {'ForeName': 'Mathijs P', 'Initials': 'MP', 'LastName': 'Hendriks', 'Affiliation': 'Department of Medical Oncology, Northwest Clinics, Alkmaar, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'van Meerten', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Joost J M E', 'Initials': 'JJME', 'LastName': 'Nuyttens', 'Affiliation': 'Department of Radiotherapy, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'Grunhagen', 'Affiliation': 'Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Cornelis', 'Initials': 'C', 'LastName': 'Verhoef', 'Affiliation': 'Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Henk M W', 'Initials': 'HMW', 'LastName': 'Verheul', 'Affiliation': 'Department of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The oncologist,['10.1634/theoncologist.2019-0693']
1277,32585261,Evaluation of various irrigation activation systems to eliminate bacteria from the root canal system: A randomized controlled single blinded trial.,"OBJECTIVE


To evaluate the effect of NaOCl irrigant activation using passive ultrasonic activation, F-files, XP-endo Finisher files and or needle irrigation alone on the reduction of intracanal bacteria from root canals in teeth undergoing root canal treatment.
METHODS


Eighty patients with asymptomatic apical periodontitis were randomly divided into four groups. Access cavities were prepared and pre-treatment samples were taken (S1). Canals were then prepared and post-instrumentation samples (S2) taken. NaOCl was then activated with the various irrigant activation systems and post-irrigation samples (S3) taken. The samples were processed and colony forming units (CFUs) of bacteria were determined. The reduction in CFUs among the experimental groups were analysed using the Kruskal Wallis test and pairwise comparisons with the Mann-Whitney test. The Friedman test was used to compare the differences in the reduction of CFUs within the groups.
RESULTS


Overall, for all groups there was a significant reduction in the CFUs from S1 to S2 (P < 0.05) and from S2 to S3 (P < 0.05). Both XP-endo Finisher and passive ultrasonic activation techniques were associated with the greatest reduction in CFUs with no significant difference between them (P = 0.24). However, both were associated with significantly lower CFUs when compared to F-file activation and needle irrigation (P < 0.05). F-file activation reduced the CFUs significantly more compared to needle irrigation (P = 0.04).
CONCLUSIONS


XP-endo Finisher file activation and passive ultrasonic activation were equivalent in terms of reduction in CFUs. F-file activation did not reduce the CFUs to the same extent as the XP-endo Finisher file and ultrasonic activation but reduced the CFUs more than needle irrigation.
CLINICAL SIGNIFICANCE


The present study highlights the effect of new XP-endo Finisher file and passive ultrasonic activation in reducing the bacterial load from the root canal system which is important for the success of root canal treatment.",2020,Both XP-endo Finisher and passive ultrasonic activation techniques were associated with the greatest reduction in CFUs with no significant difference between them (P = 0.24).,"['teeth undergoing root canal treatment', 'Eighty patients with asymptomatic apical periodontitis']","['passive ultrasonic activation, F-files, XP-endo Finisher files and or needle irrigation alone', 'new XP-endo Finisher file and passive ultrasonic activation']",['reduction in CFUs'],"[{'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0031030', 'cui_str': 'Apical periodontitis'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]",80.0,0.0138556,Both XP-endo Finisher and passive ultrasonic activation techniques were associated with the greatest reduction in CFUs with no significant difference between them (P = 0.24).,"[{'ForeName': 'Nidambur Vasudev', 'Initials': 'NV', 'LastName': 'Ballal', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Manipal College of Dental Sciences, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India. Electronic address: drballal@yahoo.com.'}, {'ForeName': 'Poornika', 'Initials': 'P', 'LastName': 'Gandhi', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Manipal College of Dental Sciences, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Padmaja A', 'Initials': 'PA', 'LastName': 'Shenoy', 'Affiliation': 'Department of Microbiology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Paul M H', 'Initials': 'PMH', 'LastName': 'Dummer', 'Affiliation': 'School of Dentistry, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103412']
1278,32585263,Restorations after selective caries removal: 5-Year randomized trial.,"OBJECTIVE


To compare the survival of restorations placed in deep caries lesions after selective caries removal to soft dentin (SCRSD) over a 5-year period. A secondary aim was to investigate whether the material (amalgam or resin composite) affected the survival of restorations.
METHODS


This study used data derived from a multicenter randomized controlled clinical trial (Clinical trials registration NCT00887952). Inclusion criteria were: patients with permanent molars presenting occlusal or proximal deep caries lesions (≥1/2 of the dentin thickness on radiographic examination), positive response to a cold test, absence of spontaneous pain, negative sensitivity to percussion, and absence of periapical lesions. The teeth were randomized into SCRSD and restoration in a single visit or stepwise excavation (SW). Each of these groups was divided according to the filling material: amalgam (AM) or resin composite (RC). Survival analyses were performed to estimate therapy success rates over 5 years (adjusted Weibull regression model).
RESULTS


172 restorations were evaluated, 95 from SCRSD group and 77 from SW group, being 61 AMG and 111 RC. The 5-year survival analysis showed similar success rates for SW (76 %) and SCRSD (79 %) as well as for AM and RC (p > 0.05).
CONCLUSION


This study showed that, after a 5-year follow-up period, the presence of decayed tissue beneath restorations in deep caries lesions did not seem to affect restoration survival. Amalgam and resin composite restorations had similar survival rates, irrespective of the caries removal technique used - SCRSD or SW.
CLINICAL SIGNIFICANCE


Selective caries removal to soft dentin can be used in the management of deep caries to avoid pulp exposure and preserve tooth structure without affecting restoration longevity.",2020,"Amalgam and resin composite restorations had similar survival rates, irrespective of the caries removal technique used - SCRSD or SW.
","['Inclusion criteria were: patients with permanent molars presenting occlusal or proximal deep caries lesions (≥1/2 of the dentin thickness on radiographic examination), positive response to a cold test, absence of spontaneous pain, negative sensitivity to percussion, and absence of periapical lesions']","['filling material: amalgam (AM) or resin composite (RC', 'material (amalgam or resin composite']","['5-year survival', 'survival rates', 'restoration survival', 'SCRSD', 'survival of restorations']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0333523', 'cui_str': 'Deep caries'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C1997216', 'cui_str': 'Spontaneous pain'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0030987', 'cui_str': 'Percussion'}, {'cui': 'C0729269', 'cui_str': 'Periapical'}]","[{'cui': 'C0440137', 'cui_str': 'Filling material'}, {'cui': 'C0440138', 'cui_str': 'Amalgam (silver) dental filling material'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}]",172.0,0.117992,"Amalgam and resin composite restorations had similar survival rates, irrespective of the caries removal technique used - SCRSD or SW.
","[{'ForeName': 'Juliana Jobim', 'Initials': 'JJ', 'LastName': 'Jardim', 'Affiliation': 'Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Heliana Dantas', 'Initials': 'HD', 'LastName': 'Mestrinho', 'Affiliation': 'Brasilia University, Brasilia, DF, Brazil.'}, {'ForeName': 'Bárbara', 'Initials': 'B', 'LastName': 'Koppe', 'Affiliation': 'Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Lilian Marly', 'Initials': 'LM', 'LastName': 'de Paula', 'Affiliation': 'Brasilia University, Brasilia, DF, Brazil.'}, {'ForeName': 'Luana Severo', 'Initials': 'LS', 'LastName': 'Alves', 'Affiliation': 'Federal University of Santa Maria, Santa Maria, RS, Brazil. Electronic address: luanaseal@gmail.com.'}, {'ForeName': 'Paulo Márcio', 'Initials': 'PM', 'LastName': 'Yamaguti', 'Affiliation': 'Brasilia University, Brasilia, DF, Brazil.'}, {'ForeName': 'Júlio César Franco', 'Initials': 'JCF', 'LastName': 'Almeida', 'Affiliation': 'Brasilia University, Brasilia, DF, Brazil.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Maltz', 'Affiliation': 'Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103416']
1279,32586427,Predictors of Cognitive Behavioral Therapy for Insomnia (CBTi) Outcomes in Active-Duty U.S. Army Personnel.,"Cognitive behavioral therapy for insomnia (CBTi) is well established as the first-line treatment for the management of chronic insomnia. Identifying predictors of response to CBTi should enable the field to efficiently utilize resources to treat those who are likely to respond and to personalize treatment approaches to optimize outcomes for those who are less likely to respond to traditional CBTi. Although a range of studies have been conducted, no clear pattern of predictors of response to CBTi has emerged. The purpose of this study was to examine the impact and relative importance of a comprehensive group of pretreatment predictors of insomnia outcomes in 99 active-duty service members who received in-person CBTi in a randomized clinical trial. Results indicated that higher levels of baseline insomnia severity and total sleep time predicted greater improvements on the Insomnia Severity Index (ISI) following treatment. Higher depression symptoms and a history of head injury predicted a worse response to treatment (i.e., smaller improvements on the ISI). Clinically meaningful improvements, as measured by the reliable change index (RCI), were found in 59% of the sample. Over and above baseline insomnia severity, only depressive symptoms predicted this outcome. Future studies should examine if modifications to CBTi based on these predictors of response can improve outcomes.",2020,"Clinically meaningful improvements, as measured by the reliable change index (RCI), were found in 59% of the sample.","['99 active-duty service members who received in-person CBTi in a randomized clinical trial', 'Insomnia (CBTi']","['Cognitive behavioral therapy', 'Cognitive Behavioral Therapy']","['baseline insomnia severity and total sleep time', 'Insomnia Severity Index (ISI', 'reliable change index (RCI', 'insomnia outcomes', 'Higher depression symptoms']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0313955,"Clinically meaningful improvements, as measured by the reliable change index (RCI), were found in 59% of the sample.","[{'ForeName': 'Kristi E', 'Initials': 'KE', 'LastName': 'Pruiksma', 'Affiliation': 'University of Texas Health Science Center at San Antonio. Electronic address: pruiksma@uthscsa.edu.'}, {'ForeName': 'Willie J', 'Initials': 'WJ', 'LastName': 'Hale', 'Affiliation': 'University of Texas Health Science Center at San Antonio; University of Texas at San Antonio.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Mintz', 'Affiliation': 'University of Texas Health Science Center at San Antonio.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'University of Texas Health Science Center at San Antonio; South Texas Veterans Health Care System, San Antonio; University of Texas at San Antonio.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'University of Texas Health Science Center at San Antonio.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Wilkerson', 'Affiliation': 'Medical University of South Carolina.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Nicholson', 'Affiliation': 'Carl R. Darnall Army Medical Center, Fort Hood, TX.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Dondanville', 'Affiliation': 'University of Texas Health Science Center at San Antonio.'}, {'ForeName': 'Brooke A', 'Initials': 'BA', 'LastName': 'Fina', 'Affiliation': 'University of Texas Health Science Center at San Antonio.'}, {'ForeName': 'Elisa V', 'Initials': 'EV', 'LastName': 'Borah', 'Affiliation': 'University of Texas Health Science Center at San Antonio.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Roache', 'Affiliation': 'University of Texas Health Science Center at San Antonio.'}, {'ForeName': 'Brett T', 'Initials': 'BT', 'LastName': 'Litz', 'Affiliation': 'VA Boston Healthcare System; Boston University.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Bryan', 'Affiliation': 'National Center for Veterans Studies, Salt Lake City, UT; University of Utah.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Taylor', 'Affiliation': 'University of Arizona.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Behavior therapy,['10.1016/j.beth.2020.02.001']
1280,32586428,Brief Behavioral Treatment for Insomnia vs. Cognitive Behavioral Therapy for Insomnia: Results of a Randomized Noninferiority Clinical Trial Among Veterans.,"The goal of this study was to compare a brief behavioral treatment for insomnia (BBTI), which has fewer sessions (4), shorter duration (<30-45 minutes), and delivers treatment in-person plus phone calls to cognitive behavioral therapy for insomnia (CBTI), which has 5 in-person sessions. The hypothesis was BBTI would be noninferior to CBTI. The Reliable Change Index was used to establish a noninferiority margin (NIM) of 3.43, representing the maximum allowable difference between groups on the pre-post Insomnia Severity Index change (ΔISI). Sixty-three veterans with chronic insomnia were randomized to either BBTI or CBTI and veterans in both groups had significant reductions of their insomnia severity per the ISI and improved their sleep onset latency, total wake time, sleep efficiency, and sleep quality per sleep diaries. While CBTI had a larger pre-post ΔISI, this was not significantly different than ΔISI BBTI and was less than the NIM. However, the 95% confidence interval of the between group pre-post ΔISI extended beyond the NIM, and thus BBTI was inconclusively noninferior to CBTI. Limitations, such as small sample size and high rate of dropout, indicate further study is needed to compare brief, alternative yet complementary behavioral insomnia interventions to CBTI. Still, evidence-based brief and flexible treatment options will help to further enhance access to care for veterans with chronic insomnia, especially in non-mental-health settings like primary care.",2020,"While CBTI had a larger pre-post ΔISI, this was not significantly different than ΔISI BBTI and was less than the NIM.","['Insomnia', 'Veterans', 'Sixty-three veterans with chronic insomnia', 'veterans with chronic insomnia']","['Brief Behavioral Treatment for Insomnia vs. Cognitive Behavioral Therapy', 'BBTI or CBTI']","['Insomnia Severity Index change (ΔISI', 'insomnia severity per the ISI and improved their sleep onset latency, total wake time, sleep efficiency, and sleep quality per sleep diaries']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]",,0.0360929,"While CBTI had a larger pre-post ΔISI, this was not significantly different than ΔISI BBTI and was less than the NIM.","[{'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Bramoweth', 'Affiliation': 'VA Pittsburgh Healthcare System. Electronic address: Adam.Bramoweth@va.gov.'}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Lederer', 'Affiliation': 'VA Pittsburgh Healthcare System.'}, {'ForeName': 'Ada O', 'Initials': 'AO', 'LastName': 'Youk', 'Affiliation': 'VA Pittsburgh Healthcare System; University of Pittsburgh.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Germain', 'Affiliation': 'University of Pittsburgh School of Medicine.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Chinman', 'Affiliation': 'VA Pittsburgh Healthcare System; RAND Corporation.'}]",Behavior therapy,['10.1016/j.beth.2020.02.002']
1281,32586429,Effectiveness of an mHealth Intervention for Infant Sleep Disturbances.,"Bedtime problems and night wakings are highly prevalent in infants. This study assessed the real-world effectiveness of an mHealth behavioral sleep intervention (Customized Sleep Profile; CSP). Caregivers (83.9% mothers) of 404 infants (age 6 to 11.9 m, M = 8.32 m, 51.2% male) used the CSP (free and publicly available behavioral sleep intervention delivered via smartphone application, Johnson's® Bedtime® Baby Sleep App). Caregivers completed the Brief Infant Sleep Questionnaire-Revised (BISQ-R) at baseline and again 4 to 28 days later. Changes in sleep patterns were analyzed, based on sleep problem status (problem versus no problem sleepers; PS; NPS). Sleep onset latency improved in both groups. Earlier bedtimes, longer continuous stretches of sleep, as well as decreased number and duration of night wakings, were evident in the PS group only. The BISQ-R Total score, total nighttime sleep, and total 24-hour sleep time improved for both groups, with a greater change for the PS group. Further, caregivers of infants in the PS group decreased feeding (bedtime and overnight) and picking up overnight, and perceived better sleep. Bedtime routine regularity, bedtime difficulty, sleep onset difficulty, and caregiver confidence improved for both groups, with the PS group showing a greater magnitude of change. Thus, a real-world, publicly available, mHealth behavioral sleep intervention was associated with improved outcomes for older infants. Intervention recommendations resulted in changes in caregivers' behavior and improvements in caregiver-reported sleep outcomes in infants, in as few as 4 days.",2020,"The BISQ-R Total score, total nighttime sleep, and total 24-hour sleep time improved for both groups, with a greater change for the PS group.","['Caregivers (83.9% mothers) of 404 infants (age 6 to 11.9 m', 'Infant Sleep Disturbances', 'older infants']","['mHealth behavioral sleep intervention (Customized Sleep Profile; CSP', ""CSP (free and publicly available behavioral sleep intervention delivered via smartphone application, Johnson's® Bedtime® Baby Sleep App"", 'mHealth Intervention']","[""caregivers' behavior and improvements in caregiver-reported sleep outcomes"", 'Bedtime routine regularity, bedtime difficulty, sleep onset difficulty, and caregiver confidence', 'BISQ-R Total score, total nighttime sleep, and total 24-hour sleep time', 'feeding (bedtime and overnight) and picking up overnight, and perceived better sleep', 'number and duration of night wakings', 'Bedtime problems and night wakings', 'Brief Infant Sleep Questionnaire-Revised (BISQ-R', 'Sleep onset latency']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010701', 'cui_str': 'Phyllodes tumour'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}]",404.0,0.0378914,"The BISQ-R Total score, total nighttime sleep, and total 24-hour sleep time improved for both groups, with a greater change for the PS group.","[{'ForeName': 'Erin S', 'Initials': 'ES', 'LastName': 'Leichman', 'Affiliation': ""Saint Joseph's University. Electronic address: erin.leichman@sju.edu.""}, {'ForeName': 'Russell A', 'Initials': 'RA', 'LastName': 'Gould', 'Affiliation': 'Johnson & Johnson Consumer Inc.'}, {'ForeName': 'Ariel A', 'Initials': 'AA', 'LastName': 'Williamson', 'Affiliation': ""Children's Hospital of Philadelphia.""}, {'ForeName': 'Russel M', 'Initials': 'RM', 'LastName': 'Walters', 'Affiliation': 'Johnson & Johnson Consumer Inc.'}, {'ForeName': 'Jodi A', 'Initials': 'JA', 'LastName': 'Mindell', 'Affiliation': ""Saint Joseph's University; Children's Hospital of Philadelphia.""}]",Behavior therapy,['10.1016/j.beth.2019.12.011']
1282,32588435,Ketogenic diets for drug-resistant epilepsy.,"BACKGROUND


Ketogenic diets (KDs) are high in fat and low in carbohydrates and have been suggested to reduce seizure frequency in people with epilepsy. Such diets may be beneficial for children with drug-resistant epilepsy. This is an update of a review first published in 2003, and last updated in 2018.
OBJECTIVES


To assess the effects of ketogenic diets for people with drug-resistant epilepsy.
SEARCH METHODS


For this update, we searched the Cochrane Register of Studies (CRS Web) and MEDLINE (Ovid, 1946 to 26 April 2019) on 29 April 2019. The Cochrane Register of Studies includes the Cochrane Epilepsy Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), and randomised controlled trials (RCTs) from Embase, ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We imposed no language restrictions. We checked the reference lists of retrieved studies for additional relevant studies.
SELECTION CRITERIA


RCTs or quasi-RCTs of KDs for people of any age with drug-resistant epilepsy.
DATA COLLECTION AND ANALYSIS


Two review authors independently applied predefined criteria to extract data and evaluated study quality. We assessed the outcomes: seizure freedom, seizure reduction (50% or greater reduction in seizure frequency), adverse effects, cognition and behaviour, quality of life, and attrition rate. We incorporated a meta-analysis. We utilised an intention-to-treat (ITT) population for all primary analyses. We presented the results as risk ratios (RRs) with 95% confidence intervals (CIs).
MAIN RESULTS


We identified 13 studies with 932 participants; 711 children (4 months to 18 years) and 221 adults (16 years and over). We assessed all 13 studies to be at high risk of performance and detection bias, due to lack of blinding. Assessments varied from low to high risk of bias for all other domains. We rated the evidence for all outcomes as low to very low certainty. Ketogenic diets versus usual care for children Seizure freedom (RR 3.16, 95% CI 1.20 to 8.35; P = 0.02; 4 studies, 385 participants; very low-certainty evidence) and seizure reduction (RR 5.80, 95% CI 3.48 to 9.65; P < 0.001; 4 studies, 385 participants; low-certainty evidence) favoured KDs (including: classic KD, medium-chain triglyceride (MCT) KD combined, MCT KD only, simplified modified Atkins diet (MAD) compared to usual care for children. We are not confident that these estimated effects are accurate. The most commonly reported adverse effects were vomiting, constipation and diarrhoea for both the intervention and usual care group, but the true effect could be substantially different (low-certainty evidence). Ketogenic diet versus usual care for adults In adults, no participants experienced seizure freedom. Seizure reduction favoured KDs (MAD only) over usual care but, again, we are not confident that the effect estimated is accurate (RR 5.03, 95% CI 0.26 to 97.68; P = 0.29; 2 studies, 141 participants; very low-certainty evidence). Adults receiving MAD most commonly reported vomiting, constipation and diarrhoea (very low-certainty evidence). One study reported a reduction in body mass index (BMI) plus increased cholesterol in the MAD group. The other reported weight loss. The true effect could be substantially different to that reported. Ketogenic diet versus ketogenic diet for children Up to 55% of children achieved seizure freedom with a classical 4:1 KD after three months whilst up to 85% of children achieved seizure reduction (very low-certainty evidence). One trial reported a greater incidence of seizure reduction with gradual-onset KD, as opposed to fasting-onset KD. Up to 25% of children were seizure free with MAD and up to 60% achieved seizure reduction. Up to 25% of children became seizure free with MAD and up to 60% experienced seizure reduction. One study used a simplified MAD (sMAD) and reported that 15% of children gained seizure freedom rates and 56% achieved seizure reduction. We judged all the evidence described as very low certainty, thus we are very unsure whether the results are accurate. The most commonly reported adverse effects were vomiting, constipation and diarrhoea (5 studies, very low-certainty evidence). Two studies reported weight loss. One stated that weight loss and gastrointestinal disturbances were more frequent, with 4:1 versus 3:1 KD, whilst one reported no difference in weight loss with 20 mg/d versus 10 mg/d carbohydrates. In one study, there was a higher incidence of hypercalcuria amongst children receiving classic KD compared to MAD. All effects described are unlikely to be accurate. Ketogenic diet versus ketogenic diet for adults One study randomised 80 adults (aged 18 years and over) to either MAD plus KetoCal during the first month with MAD alone for the second month, or MAD alone for the first month followed by MAD plus KetoCal for the second month. No adults achieved seizure freedom. More adults achieved seizure reduction at one month with MAD alone (42.5%) compared to MAD plus KetoCal (32.5%), however, by three months only 10% of adults in both groups maintained seizure reduction. The evidence for both outcomes was of very low certainty; we are very uncertain whether the effects are accurate. Constipation was more frequently reported in the MAD plus KetoCal group (17.5%) compared to the MAD only group (5%) (1 study, very low-certainty evidence). Diarrhoea and increase/change in seizure pattern/semiology were also commonly reported (17.5% to 20% of participants). The true effects of the diets could be substantially different to that reported.
AUTHORS' CONCLUSIONS


The evidence suggests that KDs could demonstrate effectiveness in children with drug-resistant epilepsy, however, the evidence for the use of KDs in adults remains uncertain. We identified a limited number of studies which all had small sample sizes. Due to the associated risk of bias and imprecision caused by small study populations, the evidence for the use of KDs was of low to very low certainty. More palatable but related diets, such as the MAD, may have a similar effect on seizure control as the classical KD, but could be associated with fewer adverse effects. This assumption requires more investigation. For people who have drug-resistant epilepsy or who are unsuitable for surgical intervention, KDs remain a valid option. Further research is required, particularly for adults with drug-resistant epilepsy.",2020,"Constipation was more frequently reported in the MAD plus KetoCal group (17.5%) compared to the MAD only group (5%) (1 study, very low-certainty evidence).","['932 participants; 711 children (4 months to 18 years) and 221 adults (16 years and over', 'children with drug-resistant epilepsy', 'people of any age with drug-resistant epilepsy', '1946 to 26 April 2019) on 29 April 2019', 'people with epilepsy', 'adults with drug-resistant epilepsy', 'For people who have drug-resistant epilepsy or who are unsuitable for surgical intervention, KDs remain a valid option', 'adults One study randomised 80 adults (aged 18 years and over) to either', 'adults', 'Adults receiving', 'people with drug-resistant epilepsy']","['Ketogenic diets', 'Ketogenic diet versus usual care', 'Ketogenic diet versus ketogenic diet', 'ketogenic diets', 'simplified MAD (sMAD', 'MAD plus KetoCal', 'Ketogenic diets versus usual care', 'MAD']","['seizure frequency), adverse effects, cognition and behaviour, quality of life, and attrition rate', 'seizure freedom rates', 'Diarrhoea', 'body mass index (BMI) plus increased cholesterol', 'seizure free with MAD', 'Constipation', 'outcomes: seizure freedom, seizure reduction', 'vomiting, constipation and diarrhoea', 'weight loss', 'weight loss and gastrointestinal disturbances', 'seizure pattern/semiology', 'seizure reduction', 'seizure freedom']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1096063', 'cui_str': 'Refractory epilepsy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0232459', 'cui_str': 'Abnormal digestive tract function'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",80.0,0.178047,"Constipation was more frequently reported in the MAD plus KetoCal group (17.5%) compared to the MAD only group (5%) (1 study, very low-certainty evidence).","[{'ForeName': 'Kirsty J', 'Initials': 'KJ', 'LastName': 'Martin-McGill', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Bresnahan', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Levy', 'Affiliation': 'The Croft Shifta Health Centre, Rochdale, UK.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Cooper', 'Affiliation': 'Centre for Clinical Neurosciences, Salford Royal Hospitals NHS Trust, Salford, UK.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD001903.pub5']
1283,31805778,The EMDR Recent Birth Trauma Protocol: a pilot randomised clinical trial after traumatic childbirth.,"Objective:  This pilot study investigated the effectiveness of brief EMDR intervention as compared to treatment-as-usual (TAU) in women with post-partum PTSD symptoms. Design:  A pilot randomised controlled trial was conducted to evaluate possible differences between one EMDR session ( n  = 19) and one TAU session ( n  = 18) delivered in a maternity ward in the aftermath of childbirth. Main Outcome Measures:  The primary outcome measure was the rate of remission of post-partum post-traumatic stress symptoms (i.e. IES-R score <23) in both groups at 6-weeks (T1) and 12-weeks' post-partum (T2). Secondary outcome measures were mother-to-infant bonding, post-partum depressive symptoms, the presence of flashbacks and level of distress. Results:  Most of the women improved their post-partum post-traumatic stress symptoms after only one treatment session. EMDR resulted more effective than TAU in reducing the proportion of women with post-partum post-traumatic stress symptoms at 6-weeks' post-partum (78.9% EMDR vs. 39.9% TAU;  p  = .020). Moreover, women treated with EMDR experienced less flashbacks and distress as compared to TAU. No significant difference was found between treatments on mother-to-infant bonding and post-partum depressive symptoms. Conclusions:  These findings, although preliminary, suggest that a brief EMDR intervention could be a viable and promising tool in the early treatment of post-traumatic stress related to traumatic childbirth.",2020,EMDR resulted more effective than TAU in reducing the proportion of women with post-partum post-traumatic stress symptoms at 6-weeks' post-partum (78.9% EMDR vs. 39.9% TAU;  ,['women with post-partum PTSD symptoms'],"['EMDR', 'EMDR session ( n \u2009=\u200919) and one TAU session ( n \u2009=\u200918) delivered in a maternity ward in the aftermath of childbirth', 'EMDR intervention', 'TAU']","['rate of remission of post-partum post-traumatic stress symptoms', 'mother-to-infant bonding and post-partum depressive symptoms', 'proportion of women with post-partum post-traumatic stress symptoms', 'flashbacks and distress', 'mother-to-infant bonding, post-partum depressive symptoms, the presence of flashbacks and level of distress']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0870535', 'cui_str': 'EMDR'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0236720', 'cui_str': 'Flashbacks'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.191435,EMDR resulted more effective than TAU in reducing the proportion of women with post-partum post-traumatic stress symptoms at 6-weeks' post-partum (78.9% EMDR vs. 39.9% TAU;  ,"[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Chiorino', 'Affiliation': 'Unit of Perinatal Psychology, Consultorio Familiare Accreditato Genitori Oggi - Mangiagalli, Milan, Italy.'}, {'ForeName': 'Maria Caterina', 'Initials': 'MC', 'LastName': 'Cattaneo', 'Affiliation': 'Unit of Perinatal Psychology, Consultorio Familiare Accreditato Genitori Oggi - Mangiagalli, Milan, Italy.'}, {'ForeName': 'Elena A', 'Initials': 'EA', 'LastName': 'Macchi', 'Affiliation': 'Unit of Perinatal Psychology, Consultorio Familiare Accreditato Genitori Oggi - Mangiagalli, Milan, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Salerno', 'Affiliation': 'Unit of Perinatal Psychology, Consultorio Familiare Accreditato Genitori Oggi - Mangiagalli, Milan, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Roveraro', 'Affiliation': 'Unit of Perinatal Psychology, Consultorio Familiare Accreditato Genitori Oggi - Mangiagalli, Milan, Italy.'}, {'ForeName': 'Giorgia G', 'Initials': 'GG', 'LastName': 'Bertolucci', 'Affiliation': 'Unit of Perinatal Psychology, Consultorio Familiare Accreditato Genitori Oggi - Mangiagalli, Milan, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Mosca', 'Affiliation': ""Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, NICU, Milan, Italy.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Fumagalli', 'Affiliation': ""Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, NICU, Milan, Italy.""}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Cortinovis', 'Affiliation': 'Department of Clinical Sciences and Community Health, Laboratory G.A. Maccacaro, University of Milan, Milan, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Carletto', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Turin, Orbassano, Italy.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Fernandez', 'Affiliation': 'Center of Research and Studies in Psychotraumatology, Milan, Italy.'}]",Psychology & health,['10.1080/08870446.2019.1699088']
1284,32613209,"Free gingival grafts vs mucosal excision in increasing the amount of keratinized mucosa during exposure of submerged orthodontic implants: a comparative, split-mouth study.","OBJECTIVES


The aim of the present study was to compare the clinical outcomes after using free gingival grafts (FGGs) and mucosal excision during exposure of submerged orthodontic implants.
METHOD AND MATERIALS


Bilateral sites in 28 subjects were divided into two groups: In the FGG group, FGG augmentation was performed around the orthodontic implants, and in the mucosal excision group, a periosteal bed was made after mucosal excision to promote attached mucosa with no additional soft-tissue augmentation. Outcomes measured during the course of the study were the width of attached mucosa, soft tissue regrowth, degree of inflammation, oral debris, and shrinkage of the attached mucosa around the orthodontic implants over a period of 3 months.
RESULTS


FGG was more effective in increasing the width of attached mucosa over simple excision of the mucosa alone (2.87 mm vs 1.5 mm; P = .001). In both the groups, there was minimal postoperative soft tissue regrowth over the orthodontic implants, with no statistical significance difference between them (P > .05). The AM in both the treatment modalities demonstrated significant shrinkage (44% in FGG group vs 68% in mucosal excision group; P = .001). However, sites receiving augmentation showed significantly less inflammation than sites treated with mucosal excision (0.63 vs 1.5; P = .001). There was no statistical difference in oral debri accumulation between both the treatment modalities (P = .43) at the end of study period.
CONCLUSION


Over a simple mucosal excision, using a FGG results in an uninflamed and immobile band of attached mucosa around an orthodontic implant, which offers greater comfort and stability during its function.",2020,"In both the groups, there was minimal postoperative soft tissue regrowth over the orthodontic implants, with no statistical significance difference between them (P > .05).",['Bilateral sites in 28 subjects'],"['mucosal excision group, a periosteal bed was made after mucosal excision to promote attached mucosa with no additional soft-tissue augmentation', 'FGG group, FGG augmentation', 'FGG', 'free gingival grafts (FGGs) and mucosal excision', 'Free gingival grafts vs mucosal excision']","['width of attached mucosa, soft tissue regrowth, degree of inflammation, oral debris, and shrinkage of the attached mucosa around the orthodontic implants over a period of 3 months', 'width of attached mucosa', 'oral debri accumulation', 'inflammation', 'shrinkage', 'minimal postoperative soft tissue regrowth']","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442033', 'cui_str': 'Periosteal'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0398967', 'cui_str': 'Free soft dentoalveolar tissue graft procedure, including donor site'}]","[{'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",28.0,0.023507,"In both the groups, there was minimal postoperative soft tissue regrowth over the orthodontic implants, with no statistical significance difference between them (P > .05).","[{'ForeName': 'Rampalli Viswa', 'Initials': 'RV', 'LastName': 'Chandra', 'Affiliation': ''}, {'ForeName': 'Kidambi', 'Initials': 'K', 'LastName': 'Sneha', 'Affiliation': ''}, {'ForeName': 'Purra', 'Initials': 'P', 'LastName': 'Anvesha', 'Affiliation': ''}]","Quintessence international (Berlin, Germany : 1985)",['10.3290/j.qi.a44893']
1285,32609523,Effectiveness of Resistive Vibration Exercise and Whey Protein Supplementation Plus Alkaline Salt on the Skeletal Muscle Proteome Following 21 Days of Bed Rest in Healthy Males.,"Muscle atrophy is a deleterious consequence of physical inactivity and is associated with increased morbidity and mortality. The aim of this study was to decipher the mechanisms involved in disuse muscle atrophy in eight healthy men using a 21 day bed rest with a cross-over design (control, with resistive vibration exercise (RVE), or RVE combined with whey protein supplementation and an alkaline salt (NEX)). The main physiological findings show a significant reduction in whole-body fat-free mass (CON -4.1%, RVE -4.3%, NEX -2.7%,  p  < 0.05), maximal oxygen consumption (CON -20.5%, RVE -6.46%, NEX -7.9%,  p  < 0.05), and maximal voluntary contraction (CON -15%, RVE -12%, and NEX -9.5%,  p  < 0.05) and a reduction in mitochondrial enzyme activity (CON -30.7%, RVE -31.3%, NEX -17%,  p  < 0.05). The benefits of nutrition and exercise countermeasure were evident with an increase in leg lean mass (CON -1.7%, RVE +8.9%, NEX +15%,  p  < 0.05). Changes to the vastus lateralis muscle proteome were characterized using mass spectrometry-based label-free quantitative proteomics, the findings of which suggest alterations to cell metabolism, mitochondrial metabolism, protein synthesis, and degradation pathways during bed rest. The observed changes were partially mitigated during RVE, but there were no significant pathway changes during the NEX trial. The mass spectrometry proteomics data have been deposited to the ProteomeXchange Consortium with the dataset identifier PXD006882. In conclusion, resistive vibration exercise, when combined with whey/alkalizing salt supplementation, could be an effective strategy to prevent skeletal muscle protein changes, muscle atrophy, and insulin sensitivity during medium duration bed rest.",2020,"The main physiological findings show a significant reduction in whole body fat free mass (CON -4.1%, RVE -4.3%, NEX -2.7%, p<0.05), maximal oxygen consumption (CON -20.5%, RVE -6.46%, NEX -7.9%, p<0.05) and maximal voluntary contraction (","['21 days of bedrest in healthy males', '8 healthy men using']","['resistive vibration exercise', '21-day bed rest with a cross-over design (control, with resistive vibration exercise (RVE) or RVE combined with whey protein supplementation and an alkaline salt (NEX', 'resistive vibration exercise and whey protein supplementation plus alkaline salt']","['whole body fat free mass', 'mitochondrial enzyme activity', 'maximal voluntary contraction ', 'morbidity and mortality', 'maximal oxygen consumption', 'leg lean mass']","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",8.0,0.031534,"The main physiological findings show a significant reduction in whole body fat free mass (CON -4.1%, RVE -4.3%, NEX -2.7%, p<0.05), maximal oxygen consumption (CON -20.5%, RVE -6.46%, NEX -7.9%, p<0.05) and maximal voluntary contraction (","[{'ForeName': 'Helena C', 'Initials': 'HC', 'LastName': 'Kenny', 'Affiliation': '3U Diabetes Partnership, School of Health and Human Performance, Dublin City University, Dublin 9, Ireland.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Tascher', 'Affiliation': 'Département Sciences Analytiques, Université de Strasbourg, CNRS, IPHC UMR 7178, F-67000 Strasbourg 67087, France.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ziemianin', 'Affiliation': 'Département Sciences Analytiques, Université de Strasbourg, CNRS, IPHC UMR 7178, F-67000 Strasbourg 67087, France.'}, {'ForeName': 'Floriane', 'Initials': 'F', 'LastName': 'Rudwill', 'Affiliation': ""Départment d'Ecologie, Physiologie et Ethologie, Université de Strasbourg, Institut Pluridisiplinaire Hubert Curien. CNRS, UMR 7178, Strasbourg 67087, France.""}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Zahariev', 'Affiliation': ""Départment d'Ecologie, Physiologie et Ethologie, Université de Strasbourg, Institut Pluridisiplinaire Hubert Curien. CNRS, UMR 7178, Strasbourg 67087, France.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Chery', 'Affiliation': ""Départment d'Ecologie, Physiologie et Ethologie, Université de Strasbourg, Institut Pluridisiplinaire Hubert Curien. CNRS, UMR 7178, Strasbourg 67087, France.""}, {'ForeName': 'Guillemette', 'Initials': 'G', 'LastName': 'Gauquelin-Koch', 'Affiliation': ""Centre National d'Etudes Spatiales (CNES), Paris 75001, France.""}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Barielle', 'Affiliation': 'Institut de Médecine et de Physiologie Spatiales, Toulouse 31400, France.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Heer', 'Affiliation': 'Profil, Hellersbergstrasse 9, Neuss D-41460, Germany.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Blanc', 'Affiliation': ""Départment d'Ecologie, Physiologie et Ethologie, Université de Strasbourg, Institut Pluridisiplinaire Hubert Curien. CNRS, UMR 7178, Strasbourg 67087, France.""}, {'ForeName': 'Donal J', 'Initials': 'DJ', 'LastName': ""O'Gorman"", 'Affiliation': '3U Diabetes Partnership, School of Health and Human Performance, Dublin City University, Dublin 9, Ireland.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Bertile', 'Affiliation': 'Département Sciences Analytiques, Université de Strasbourg, CNRS, IPHC UMR 7178, F-67000 Strasbourg 67087, France.'}]",Journal of proteome research,['10.1021/acs.jproteome.0c00256']
1286,32610059,Behavioral economics informed message content in text message reminders to improve cervical screening participation: Two pragmatic randomized controlled trials.,"The objective of the reported research was to assess the impact of text message (SMS) reminders and their content on cervical screening rates. Women invited for cervical screening in Northwest London from February-October 2015 were eligible. 3133 women aged 24-29 (Study 1) were randomized (1, 1) to 'no SMS' (control), or a primary care physician (PCP) endorsed SMS (SMS-PCP). 11,405 women aged 30-64 (Study 2), were randomized (1, 1:1:1:1:1:1) to either: no SMS, an SMS without manipulation (SMS), the SMS-PCP, an SMS with a total or proportionate social norm (SMS-SNT or SMS-SNP), or an SMS with a gain-framed or loss-framed message (SMS-GF and SMS-LF). The primary outcome was participation at 18 weeks. In Study 1 participation was significantly higher in the SMS-PCP arm (31.4%) compared to control (26.4%, aOR, 1.29, 95%CI: 1.09-1·51; p = 0.002). In Study 2 participation was highest in the SMS-PCP (38.4%) and SMS (38.1%) arms compared to control (34.4%), (aOR: 1.19, 95%CI: 1.03-1.38; p = 0.02 and aOR: 1.18, 95%CI: 1.02-1.37; p = 0.03, respectively). The results demonstrate that behavioral SMSs improve cervical screening participation. The message content plays an important role in the impact of SMS. The results from this trial have already been used to designing effective policy for cervical cancer screening. The NHS Cervical Screening Programme started running a London-wide screening SMS campaign which was based on the cervical screening trial described here. According to figures published by Public Health England, after six months attendance increased by 4.8%, which is the equivalent of 13,400 more women being screened at 18 weeks.",2020,"In Study 1 participation was significantly higher in the SMS-PCP arm (31.4%) compared to control (26.4%, aOR, 1.29, 95%CI: 1.09-1·51; p = 0.002).","['3133 women aged 24-29 (Study 1', 'Women invited for cervical screening in Northwest London from February-October 2015 were eligible', '11,405 women aged 30-64 (Study 2']","['behavioral SMSs', ""no SMS' (control), or a primary care physician (PCP) endorsed SMS (SMS-PCP""]","['cervical screening participation', 'SMS-PCP', 'cervical screening rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0023973', 'cui_str': 'London'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0795864', 'cui_str': 'Smith-Magenis syndrome'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}]",11405.0,0.199584,"In Study 1 participation was significantly higher in the SMS-PCP arm (31.4%) compared to control (26.4%, aOR, 1.29, 95%CI: 1.09-1·51; p = 0.002).","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Huf', 'Affiliation': ""Department of Surgery and Cancer, Imperial College London, St Mary's Hospital Campus, 10th Floor Queen Elizabeth Queen Mother Wing, Praed Street, London W2 1NY, UK.""}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Kerrison', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'King', 'Affiliation': ""Department of Surgery and Cancer, Imperial College London, St Mary's Hospital Campus, 10th Floor Queen Elizabeth Queen Mother Wing, Praed Street, London W2 1NY, UK.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Chadborn', 'Affiliation': 'Public Health England, Wellington House, 133-155 Waterloo Road, London SE1 8UG, UK.'}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Richmond', 'Affiliation': 'Breast Cancer Now, 5th Floor Ibex House, 42-47 Minories, London EC3N 1DY, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'West of London Breast Screening Service, Imperial College Healthcare NHS Trust, First Floor, Charing Cross Hospital, Fulham Palace Road, London W6 8RF, UK.'}, {'ForeName': 'Ellis', 'Initials': 'E', 'LastName': 'Friedman', 'Affiliation': 'Faculty of Public Health, 4 St Andrews Place, London NW1 4LB, UK.'}, {'ForeName': 'Heema', 'Initials': 'H', 'LastName': 'Shukla', 'Affiliation': 'Global Health Capacity, Unit 4, Vista Place, Coy Pond Business Park Ingworth Road, Poole, BH12 1JY, UK.'}, {'ForeName': 'Fu-Min', 'Initials': 'FM', 'LastName': 'Tseng', 'Affiliation': ""Department of Surgery and Cancer, Imperial College London, St Mary's Hospital Campus, 10th Floor Queen Elizabeth Queen Mother Wing, Praed Street, London W2 1NY, UK.""}, {'ForeName': 'Gaby', 'Initials': 'G', 'LastName': 'Judah', 'Affiliation': ""Department of Surgery and Cancer, Imperial College London, St Mary's Hospital Campus, 10th Floor Queen Elizabeth Queen Mother Wing, Praed Street, London W2 1NY, UK.""}, {'ForeName': 'Ara', 'Initials': 'A', 'LastName': 'Darzi', 'Affiliation': ""Department of Surgery and Cancer, Imperial College London, St Mary's Hospital Campus, 10th Floor Queen Elizabeth Queen Mother Wing, Praed Street, London W2 1NY, UK.""}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Vlaev', 'Affiliation': 'Warwick Business School, University of Warwick, Scarman Rd, Coventry CV4 7AL, UK. Electronic address: ivo.vlaev@wbs.ac.uk.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106170']
1287,32610672,Effects of Bag Mask Ventilation and Advanced Airway Management on Adherence to Ventilation Recommendations and Chest Compression Fraction: A Prospective Randomized Simulator-Based Trial.,"The role of advanced airway management (AAM) in cardiopulmonary resuscitation (CPR) is currently debated as observational studies reported better outcomes after bag-mask ventilation (BMV), and the only prospective randomized trial was inconclusive. Adherence to CPR guidelines ventilation recommendations is unknown and difficult to assess in clinical trials. This study compared AAM and BMV with regard to adherence to ventilation recommendations and chest compression fractions in simulated cardiac arrests. A total of 154 teams of 3-4 physicians were randomized to perform CPR with resuscitation equipment restricting airway management to BMV only or equipment allowing for all forms of AAM. BMV teams ventilated 6 ± 6/min and AAM teams 19 ± 8/min (range 3-42/min;  p  < 0.0001 vs. BMV). 68/78 BMV teams and 23/71 AAM teams adhered to the ventilation recommendations ( p  < 0.0001). BMV teams had lower compression fractions than AAM teams (78 ± 7% vs. 86 ± 6%,  p  < 0.0001) resulting entirely from higher no-flow times for ventilation (9 ± 4% vs. 3 ± 3 %;  p  < 0.0001). Compared to BMV, AAM leads to significant hyperventilation and lower adherence to ventilation recommendations but favourable compression fractions. The cumulative effect of deviations from ventilation recommendations has the potential to blur findings in clinical trials.",2020,68/78 BMV teams and 23/71 AAM teams adhered to the ventilation recommendations ( p  < 0.0001).,['A total of 154 teams of 3-4 physicians'],"['bag-mask ventilation (BMV', 'advanced airway management (AAM', 'cardiopulmonary resuscitation (CPR', 'CPR with resuscitation equipment restricting airway management to BMV only or equipment allowing for all forms of AAM', 'Bag Mask Ventilation and Advanced Airway Management']","['compression fractions', 'Adherence to Ventilation Recommendations and Chest Compression Fraction']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]","[{'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]","[{'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}]",,0.0244432,68/78 BMV teams and 23/71 AAM teams adhered to the ventilation recommendations ( p  < 0.0001).,"[{'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Department of Anaesthesiology, Bethesda Hospital, 47053 Duisburg, Germany.'}, {'ForeName': 'Timur', 'Initials': 'T', 'LastName': 'Sellmann', 'Affiliation': 'Department of Anaesthesiology, Bethesda Hospital, 47053 Duisburg, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Wetzchewald', 'Affiliation': 'Institution for Emergency Medicine, 59755 Arnsberg, Germany.'}, {'ForeName': 'Heidrun', 'Initials': 'H', 'LastName': 'Schwager', 'Affiliation': 'Institution for Emergency Medicine, 59755 Arnsberg, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Russo', 'Affiliation': 'Department of Anaesthesiology 1, Witten/Herdecke University, 58455 Witten, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Marsch', 'Affiliation': 'Department of Intensive Care, University Hospital, 4031 Basel, Switzerland.'}]",Journal of clinical medicine,['10.3390/jcm9072045']
1288,31427720,The impact of complex karyotype on the overall survival of patients with relapsed chronic lymphocytic leukemia treated with idelalisib plus rituximab.,,2020,,['patients with relapsed chronic lymphocytic leukemia treated with'],"['idelalisib plus rituximab', 'complex karyotype']",['overall survival'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C2698692', 'cui_str': 'idelalisib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0022526', 'cui_str': 'Karyotype determination'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0533494,,"[{'ForeName': 'Karl-Anton', 'Initials': 'KA', 'LastName': 'Kreuzer', 'Affiliation': 'Department I of Internal Medicine, University of Cologne, Cologne, Germany. karl-anton.kreuzer@uni-koeln.de.'}, {'ForeName': 'Richard R', 'Initials': 'RR', 'LastName': 'Furman', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Department III of Internal Medicine, Ulm University Medical Center, Ulm, Germany.'}, {'ForeName': 'Ronald L', 'Initials': 'RL', 'LastName': 'Dubowy', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Yeonhee', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Veerendra', 'Initials': 'V', 'LastName': 'Munugalavadla', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Lilienweiss', 'Affiliation': 'Department I of Internal Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Hans Christian', 'Initials': 'HC', 'LastName': 'Reinhardt', 'Affiliation': 'Department I of Internal Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Cramer', 'Affiliation': 'Department I of Internal Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Eichhorst', 'Affiliation': 'Department I of Internal Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': ""St. James's University Hospital, Leeds, UK.""}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': 'University of California-Irvine, Irvine Chao Family Comprehensive Cancer Center, Orange, CA, USA.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Pettitt', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Department I of Internal Medicine, University of Cologne, Cologne, Germany.'}]",Leukemia,['10.1038/s41375-019-0533-6']
1289,32615145,Does connectedness to nature improve the eating behaviours of pre-schoolers? Emerging evidence from the Play&Grow randomised controlled trial in Hong Kong.,"BACKGROUND


Nature-based interventions, which focus on outdoor play, mental health, and self-directed autonomous play, are becoming popular in promoting well-being. The objective of this study was to test whether connecting to nature would contribute to better feeding and eating habits in families with pre-schoolers.
METHODS


241 families with children aged two to five were randomly assigned to the Intervention (IG) and Control Groups (CG). IG received 10 sessions of a family-based programme, which included a novel Connectedness to Nature (CN) element. CG received only the government's health recommendations. The effectiveness of the intervention's primary outcomes (CN, eating/feeding behaviours) was analysed by a repeated measures structural equation model with intervention status as a causal predictor.
RESULTS


204 families (IG, n = 120; CG, n = 84) completed the measurements before and after the trial. The intervention had a medium effect on caregivers' CN (f 2  = 0.16, (95%CI = 0.06, 0.30)) and a large effect on children's CN (f 2  = 0.58, (95%CI = 0.36, 0.89)). In the IG, children's CN strongly predicted caregivers' feeding style (β = 0.48 (p < .01, 95%CI = 0.14, 0.83)) and moderately, children's eating behaviours (β = 0.21 (p = .16, 95%CI = -0.09, 0.52)). This produced a positive trend for greater vegetable consumption in the IG compared to the CG (β = 0.20 (95%CI = 0.01, 0.39) vs. β = -0.05, (95%CI = -0.18, 0.08)). Interestingly, the path values in the CG significantly reflected the traditional pattern, (e.g., parental feeding style strongly influenced children's eating behaviour (β = 0.33, p = .001, 95%CI = 0.13, 0.54).
CONCLUSIONS


The Play&Grow intervention positively increased caregivers' and children's CN. It also improved eating behaviors in children independent of their caregivers' feeding style. This may indicate a higher degree of autonomy in children's eating behaviour if they are exposed to nature. Further research should test the CN component in promotion of healthy eating in pre-schoolers.",2020,"The intervention had a medium effect on caregivers' CN (f 2  = 0.16, (95%CI = 0.06, 0.30)) and a large effect on children's CN (f 2  = 0.58, (95%CI = 0.36, 0.89)).","['241 families with children aged two to five', '204 families (IG n\u202f=\u202f120, CG n\u202f=\u202f84']","['Intervention (IG) and Control Groups (CG', 'Play&Grow intervention']","[""children's eating behaviours"", 'vegetable consumption', 'feeding and eating habits', ""caregivers' feeding style"", ""caregivers' and children's CN"", ""children's eating behaviour"", 'eating behaviors']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0349590', 'cui_str': 'Nature'}]",241.0,0.128134,"The intervention had a medium effect on caregivers' CN (f 2  = 0.16, (95%CI = 0.06, 0.30)) and a large effect on children's CN (f 2  = 0.58, (95%CI = 0.36, 0.89)).","[{'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Sobko', 'Affiliation': 'School of Biological Sciences, Faculty of Science, The University of Hong Kong, Hong Kong. Electronic address: tsobko@hku.hk.'}, {'ForeName': 'Gavin T L', 'Initials': 'GTL', 'LastName': 'Brown', 'Affiliation': 'Quantitative Data Analysis and Research Unit, Faculty of Education & Social Work, The University of Auckland, New Zealand.'}, {'ForeName': 'Will H G', 'Initials': 'WHG', 'LastName': 'Cheng', 'Affiliation': 'School of Biological Sciences, Faculty of Science, The University of Hong Kong, Hong Kong.'}]",Appetite,['10.1016/j.appet.2020.104781']
1290,32615462,The effect of baclofen on objective and subjective sleep measures in a model of transient insomnia.,"STUDY OBJECTIVES


Insomnia is a common medical complaint. Current pharmacologic treatments have modest efficacy and numerous side effects. Baclofen is a gamma-aminobutyric acid (GABA)b receptor agonist used to treat spasticity in various medical conditions. Several studies noted that baclofen, when used to treat sleep related disorders, resulted in improvement in sleep parameters. Measures of insomnia, however, were not assessed in those studies. To date, baclofen has not been assessed for efficacy in the treatment of insomnia.
METHODS


We randomized 20 healthy subjects to baclofen or placebo in a cross over design. All subjects underwent two polysomnograms (PSG) assessing sleep parameters. Baclofen or placebo was given 90 min prior to lights out in random order for each subject. Lights out occurred two hours earlier than the subject's median habitual bedtime.
RESULTS


Baclofen resulted in significantly less objective wake after sleep onset and stage 1 sleep, and significantly increased total sleep time (TST), sleep efficiency, and stage 3/4 sleep. There was no effect on sleep onset latency (SOL). Self-report variables indicated significantly less subjective awakenings from sleep and increased subjective sleep quality. There was no effect on subjective TST or subjective SOL.
CONCLUSIONS


This study showed that baclofen was superior to placebo with regard to several objective and subjective measures used to assess sleep quality. These data support the notion that baclofen shows promise as an effective hypnotic drug.",2020,This study showed that baclofen was superior to placebo with regard to several objective and subjective measures used to assess sleep quality.,['20 healthy subjects to'],"['baclofen', 'baclofen or placebo', 'Baclofen or placebo', 'placebo']","['subjective awakenings from sleep and increased subjective sleep quality', 'sleep parameters', 'sleep onset latency (SOL', 'subjective TST or subjective SOL', 'total sleep time (TST), sleep efficiency, and stage 3/4 sleep', 'objective wake after sleep onset and stage 1 sleep', 'sleep quality', 'objective and subjective sleep measures']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",20.0,0.028149,This study showed that baclofen was superior to placebo with regard to several objective and subjective measures used to assess sleep quality.,"[{'ForeName': 'Samih', 'Initials': 'S', 'LastName': 'Raad', 'Affiliation': 'University of Oklahoma Health Sciences Center, Section of Pulmonary Critical Care & Sleep Medicine, Oklahoma City, OK, USA. Electronic address: Samih-Raad@ouhsc.edu.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Wilkerson', 'Affiliation': 'Lynn Health Science Institute, Oklahoma City, OK, USA. Electronic address: Meredith-Wilkerson@ouhsc.edu.'}, {'ForeName': 'Kellie R', 'Initials': 'KR', 'LastName': 'Jones', 'Affiliation': 'University of Oklahoma Health Sciences Center, Section of Pulmonary Critical Care & Sleep Medicine, Oklahoma City, OK, USA. Electronic address: Kellie-Jones@ouhsc.edu.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Orr', 'Affiliation': 'University of Oklahoma Health Sciences Center, Lynn Health Science Institute, Oklahoma City, OK, USA. Electronic address: worr@lhsi.net.'}]",Sleep medicine,['10.1016/j.sleep.2020.03.028']
1291,32616022,Sources of potential bias when combining routine data linkage and a national survey of secondary school-aged children: a record linkage study.,"BACKGROUND


Linking survey data to administrative records requires informed participant consent. When linkage includes child data, this includes parental and child consent. Little is known of the potential impacts of introducing consent to data linkage on response rates and biases in school-based surveys. This paper assessed: i) the impact on overall parental consent rates and sample representativeness when consent for linkage was introduced and ii) the quality of identifiable data provided to facilitate linkage.
METHODS


Including an option for data linkage was piloted in a sub-sample of schools participating in the Student Health and Wellbeing survey, a national survey of adolescents in Wales, UK. Schools agreeing to participate were randomized 2:1 to receive versus not receive the data linkage question. Survey responses from consenting students were anonymised and linked to routine datasets (e.g. general practice, inpatient, and outpatient records). Parental withdrawal rates were calculated for linkage and non-linkage samples. Multilevel logistic regression models were used to compare characteristics between: i) consenters and non-consenters; ii) successfully and unsuccessfully linked students; and iii) the linked cohort and peers within the general population, with additional comparisons of mental health diagnoses and health service contacts.
RESULTS


The sub-sample comprised 64 eligible schools (out of 193), with data linkage piloted in 39. Parental consent was comparable across linkage and non-linkage schools. 48.7% (n = 9232) of students consented to data linkage. Modelling showed these students were more likely to be younger, more affluent, have higher positive mental wellbeing, and report fewer risk-related behaviours compared to non-consenters. Overall, 69.8% of consenting students were successfully linked, with higher rates of success among younger students. The linked cohort had lower rates of mental health diagnoses (5.8% vs. 8.8%) and specialist contacts (5.2% vs. 7.7%) than general population peers.
CONCLUSIONS


Introducing data linkage within a national survey of adolescents had no impact on study completion rates. However, students consenting to data linkage, and those successfully linked, differed from non-consenting students on several key characteristics, raising questions concerning the representativeness of linked cohorts. Further research is needed to better understand decision-making processes around providing consent to data linkage in adolescent populations.",2020,"The linked cohort had lower rates of mental health diagnoses (5.8% vs. 8.8%) and specialist contacts (5.2% vs. 7.7%) than general population peers.
","['secondary school-aged children', '64 eligible schools (out of 193), with data linkage piloted in 39', 'consenting students were anonymised and linked to routine datasets (e.g. general practice, inpatient, and outpatient records', 'cohort and peers within the general population, with additional comparisons of mental health diagnoses and health service contacts', 'Including an option for data linkage was piloted in a sub-sample of schools participating in the Student Health and Wellbeing survey, a national survey of adolescents in Wales, UK']",[],"['mental health diagnoses', 'positive mental wellbeing', 'Parental withdrawal rates', 'specialist contacts']","[{'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0242239', 'cui_str': 'Data Linkage'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043015', 'cui_str': 'Wales'}]",[],"[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",,0.0463772,"The linked cohort had lower rates of mental health diagnoses (5.8% vs. 8.8%) and specialist contacts (5.2% vs. 7.7%) than general population peers.
","[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Morgan', 'Affiliation': 'Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), School of Social Sciences, Cardiff University, Cardiff, CF10 3BD, UK. morgank22@cardiff.ac.uk.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Page', 'Affiliation': 'Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), School of Social Sciences, Cardiff University, Cardiff, CF10 3BD, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': 'Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), School of Social Sciences, Cardiff University, Cardiff, CF10 3BD, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Long', 'Affiliation': 'Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), School of Social Sciences, Cardiff University, Cardiff, CF10 3BD, UK.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Hewitt', 'Affiliation': 'Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), School of Social Sciences, Cardiff University, Cardiff, CF10 3BD, UK.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Del Pozo-Banos', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'John', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Murphy', 'Affiliation': 'Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), School of Social Sciences, Cardiff University, Cardiff, CF10 3BD, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Moore', 'Affiliation': 'Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), School of Social Sciences, Cardiff University, Cardiff, CF10 3BD, UK.'}]",BMC medical research methodology,['10.1186/s12874-020-01064-1']
1292,32484444,A Social Media-Based Support Group for Youth Living With HIV in Nigeria (SMART Connections): Randomized Controlled Trial.,"BACKGROUND


Youth living with HIV (YLHIV) enrolled in HIV treatment experience higher loss to follow-up, suboptimal treatment adherence, and greater HIV-related mortality compared with younger children or adults. Despite poorer health outcomes, few interventions target youth specifically. Expanding access to mobile phone technology, in low- and middle-income countries (LMICs) in particular, has increased interest in using this technology to improve health outcomes. mHealth interventions may present innovative opportunities to improve adherence and retention among YLHIV in LMICs.
OBJECTIVE


This study aimed to test the effectiveness of a structured support group intervention, Social Media to promote Adherence and Retention in Treatment (SMART) Connections, delivered through a social media platform, on HIV treatment retention among YLHIV aged 15 to 24 years and on secondary outcomes of antiretroviral therapy (ART) adherence, HIV knowledge, and social support.
METHODS


We conducted a parallel, unblinded randomized controlled trial. YLHIV enrolled in HIV treatment for less than 12 months were randomized in a 1:1 ratio to receive SMART Connections (intervention) or standard of care alone (control). We collected data at baseline and endline through structured interviews and medical record extraction. We also conducted in-depth interviews with subsets of intervention group participants. The primary outcome was retention in HIV treatment. We conducted a time-to-event analysis examining time retained in treatment from study enrollment to the date the participant was no longer classified as active-on-treatment.
RESULTS


A total of 349 YLHIV enrolled in the study and were randomly allocated to the intervention group (n=177) or control group (n=172). Our primary analysis included data from 324 participants at endline. The probability of being retained in treatment did not differ significantly between the 2 study arms during the study. Retention was high at endline, with 75.7% (112/163) of intervention group participants and 83.4% (126/161) of control group participants active on treatment. HIV-related knowledge was significantly better in the intervention group at endline, but no statistically significant differences were found for ART adherence or social support. Intervention group participants overwhelmingly reported that the intervention was useful, that they enjoyed taking part, and that they would recommend it to other YLHIV.
CONCLUSIONS


Our findings of improved HIV knowledge and high acceptability are encouraging, despite a lack of measurable effect on retention. Retention was greater than anticipated in both groups, likely a result of external efforts that began partway through the study. Qualitative data indicate that the SMART Connections intervention may have contributed to retention, adherence, and social support in ways that were not captured quantitatively. Web-based delivery of support group interventions can permit people to access information and other group members privately, when convenient, and without travel. Such digital health interventions may help fill critical gaps in services available for YLHIV.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03516318; https://clinicaltrials.gov/ct2/show/NCT03516318.",2020,"HIV-related knowledge was significantly better in the intervention group at endline, but no statistically significant differences were found for ART adherence or social support.","['YLHIV aged 15 to 24 years and on secondary outcomes of antiretroviral therapy (ART) adherence, HIV knowledge, and social support', 'Youth living with HIV (YLHIV', 'A total of 349 YLHIV enrolled in the study and were randomly allocated to the intervention group (n=177) or control group (n=172', 'YLHIV enrolled in HIV treatment for less than 12 months', 'Youth Living With HIV in Nigeria (SMART Connections', '324 participants at endline']","['structured support group intervention, Social Media', 'SMART Connections intervention', 'SMART Connections (intervention) or standard of care alone (control']","['Retention', 'probability of being retained', 'ART adherence or social support', 'retention in HIV treatment', 'HIV-related knowledge']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C4517713', 'cui_str': '324'}]","[{'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",349.0,0.189111,"HIV-related knowledge was significantly better in the intervention group at endline, but no statistically significant differences were found for ART adherence or social support.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Dulli', 'Affiliation': 'FHI 360, Durham, NC, United States.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Ridgeway', 'Affiliation': 'FHI 360, Durham, NC, United States.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Packer', 'Affiliation': 'FHI 360, Durham, NC, United States.'}, {'ForeName': 'Kate R', 'Initials': 'KR', 'LastName': 'Murray', 'Affiliation': 'FHI 360, Durham, NC, United States.'}, {'ForeName': 'Tolulope', 'Initials': 'T', 'LastName': 'Mumuni', 'Affiliation': 'Center for Population and Reproductive Health, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Kate F', 'Initials': 'KF', 'LastName': 'Plourde', 'Affiliation': 'FHI 360, Durham, NC, United States.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'FHI 360, Durham, NC, United States.'}, {'ForeName': 'Adesola', 'Initials': 'A', 'LastName': 'Olumide', 'Affiliation': 'Center for Population and Reproductive Health, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Oladosu', 'Initials': 'O', 'LastName': 'Ojengbede', 'Affiliation': 'Center for Population and Reproductive Health, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Donna R', 'Initials': 'DR', 'LastName': 'McCarraher', 'Affiliation': 'FHI 360, Durham, NC, United States.'}]",Journal of medical Internet research,['10.2196/18343']
1293,32484446,Promoting Antenatal Care Attendance Through a Text Messaging Intervention in Samoa: Quasi-Experimental Study.,"BACKGROUND


Antenatal care (ANC) has the potential to improve maternal health, but it remains underutilized and unevenly implemented in many low- and middle-income countries. Increasingly, text messaging programs for pregnant women show evidence that they can improve the utilization of ANC during pregnancy; however, gaps remain regarding how implementation affects outcomes.
OBJECTIVE


This study aimed to assess facilitators and barriers to implementation of an SMS text messaging intervention for pregnant women in Samoa and to assess its impact on ANC attendance.
METHODS


This study took place in Upolu, Samoa, from March to August 2014 and employed a quasi-experimental design. Half (n=3) of the public antenatal clinics on the island offered adult pregnant women the SMS text messaging intervention, with 552 women registering for the messages. At the comparison clinics (n=3), 255 women registered and received usual care. The intervention consisted of unidirectional text messages containing health tips and appointment reminders. The outcome of interest was the number of attended antenatal visits. Implementation data were also collected through a survey of the participating midwives (n=7) and implementation notes. Data analysis included a comparison of women's baseline characteristics between the two groups, followed by the use of negative binomial regressions to test for associations between participation in the intervention and increased ANC attendance, controlling for individual characteristics and accounting for the clustering of women within clinics.
RESULTS


The comparison of ANC attendance rates found that women receiving the SMS text messaging intervention attended 15% fewer ANC visits than the comparison group (P=.004), controlling for individual characteristics and clustering. Data analysis of the implementation process suggests that barriers to successful implementation include women registering very late in pregnancy, sharing their phone with others, and inconsistent explanation of the intervention to women.
CONCLUSIONS


These results suggest that unidirectional text messages do not encourage, and might even discourage, ANC attendance in Samoa. Interpreted with other evidence in the literature, these results suggest that SMS text messaging interventions are more effective when they facilitate better communication between patients and health workers. This study is an important contribution to our understanding of when SMS text messaging interventions are and are not effective in improving maternal health care utilization.",2020,"The comparison of ANC attendance rates found that women receiving the SMS text messaging intervention attended 15% fewer ANC visits than the comparison group (P=.004), controlling for individual characteristics and clustering.","['pregnant women in Samoa', 'Half (n=3) of the public antenatal clinics on the island offered adult pregnant women the', '255 women registered and received usual care', '552 women registering for the messages', 'pregnant women']","['SMS text messaging intervention', 'unidirectional text messages containing health tips and appointment reminders', 'SMS text messaging interventions']","['ANC attendance rates', 'number of attended antenatal visits']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0242537', 'cui_str': 'Navigator Islands'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0022130', 'cui_str': 'Island'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}]",255.0,0.0661568,"The comparison of ANC attendance rates found that women receiving the SMS text messaging intervention attended 15% fewer ANC visits than the comparison group (P=.004), controlling for individual characteristics and clustering.","[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Watterson', 'Affiliation': 'School of Public Health, University of California, Berkeley, Berkeley, CA, United States.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Castaneda', 'Affiliation': 'Facebook Research, Menlo Park, CA, United States.'}, {'ForeName': 'Caricia', 'Initials': 'C', 'LastName': 'Catalani', 'Affiliation': 'Design for Health, IDEO, San Francisco, CA, United States.'}]",JMIR mHealth and uHealth,['10.2196/15890']
1294,32484448,"Comparing a Social and Communication App, Telephone Intervention, and Usual Care for Diabetes Self-Management: 3-Arm Quasiexperimental Evaluation Study.","BACKGROUND


Many technology-assisted innovations have been used to manage disease. However, most of these innovations are not broadly used by older adults due to their cost. Additionally, disease management through technology-assisted innovations has not been compared with other interventions.
OBJECTIVE


In this study, we tested the employment of a free and widely used social and communication app to help older adults with diabetes manage their distress and glycemic control. We also compared the effectiveness of the app with 2 other methods, namely telephone and conventional health education, and determined which subgroup experiences the most effects within each intervention.
METHODS


Adults aged ≥50 years with type 2 diabetes were recruited from Southern Taiwan (N=231) and were allocated to different 3-month interventions. Informed consent was obtained at the Ministry of Science and Technology and approved by the National Cheng Kung University Hospital Institutional Review Board (No. A-ER-102-425).
RESULTS


Participants in the mobile-based group had significant reductions in hemoglobin A1c compared with the telephone-based and usual care groups (mean changes of -0.4%, 0.1%, and 0.03%, respectively; P=.02). Diabetes-specific distress decreased to a greater extent in the mobile-based group compared to the other 2 groups (mean changes of -5.16, -3.49, and -2.44, respectively, P=.02). Subgroup analyses further revealed that the effects on reducing blood glucose levels in the social and communication app groups were especially evident in patients with lower distress scores, and diabetes-related distress was especially evident in participants who were younger than 60 years or had higher educational levels.
CONCLUSIONS


The findings of this study inform more flexible use of social and communication apps with in-person diabetes education and counselling.",2020,"RESULTS


Participants in the mobile-based group had significant reductions in hemoglobin A1c compared with the telephone-based and usual care groups (mean changes of -0.4%, 0.1%, and 0.03%, respectively; P=.02).","['Adults aged ≥50 years with type 2 diabetes were recruited from Southern Taiwan (N=231', 'older adults with diabetes manage their distress and glycemic control']","['Social and Communication App, Telephone Intervention, and Usual Care']","['blood glucose levels', 'hemoglobin A1c', 'diabetes-related distress', 'Diabetes-specific distress']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",,0.0432114,"RESULTS


Participants in the mobile-based group had significant reductions in hemoglobin A1c compared with the telephone-based and usual care groups (mean changes of -0.4%, 0.1%, and 0.03%, respectively; P=.02).","[{'ForeName': 'Ching-Ju', 'Initials': 'CJ', 'LastName': 'Chiu', 'Affiliation': 'Institute of Gerontology, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Yung-Chen', 'Initials': 'YC', 'LastName': 'Yu', 'Affiliation': 'Department of Nursing, National Cheng Kung University Hospital, Tainan, Taiwan.'}, {'ForeName': 'Ye-Fong', 'Initials': 'YF', 'LastName': 'Du', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, National Cheng Kung University Hospital, Tainan, Taiwan.'}, {'ForeName': 'Yi-Ching', 'Initials': 'YC', 'LastName': 'Yang', 'Affiliation': 'Department of Family Medicine, National Cheng Kung University Hospital, Tainan, Taiwan.'}, {'ForeName': 'Jou-Yin', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': 'Department of Public Health, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Li-Ping', 'Initials': 'LP', 'LastName': 'Wong', 'Affiliation': 'Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Chanuantong', 'Initials': 'C', 'LastName': 'Tanasugarn', 'Affiliation': 'Faculty of Public Health, Mahidol University, Bangkok, Thailand.'}]",JMIR mHealth and uHealth,['10.2196/14024']
1295,32485917,Tibial Nerve Block: Supramalleolar or Retromalleolar Approach? A Randomized Trial in 110 Participants.,"Of the five nerves that innervate the foot, the one in which anesthetic blocking presents the greatest difficulty is the tibial nerve. The aim of this clinical trial was to establish a protocol for two tibial nerve block anesthetic techniques to later compare the anesthetic efficiency of retromalleolar blocking and supramalleolar blocking in order to ascertain whether the supramalleolar approach achieved a higher effective blocking rate. A total of 110 tibial nerve blocks were performed. Location of the injection site was based on a prior ultrasound assessment of the tibial nerve. The block administered was 3 mL of 2% mepivacaine. The two anesthetic techniques under study provided very similar clinical results. The tibial nerve success rate was 81.8% for the retromalleolar technique and 78.2% for the supramalleolar technique. No significant differences in absolute latency time ( p  = 0.287), percentage of effective nerve blocks ( p  = 0.634), anesthetic block duration ( p  = 0.895), or pain level during puncture ( p  = 0.847) were found between the two techniques. The greater ease in locating the tibial nerve at the retromalleolar approach could suggest that this is the technique of choice for tibial nerve blocking, especially in the case of professionals new to the field. The supramalleolar technique could be worth considering for those more experienced professionals.",2020,"No significant differences in absolute latency time ( p  = 0.287), percentage of effective nerve blocks ( p  = 0.634), anesthetic block duration ( p  = 0.895), or pain level during puncture ( p  = 0.847) were found between the two techniques.",['110 Participants'],['mepivacaine'],"['absolute latency time', 'pain level', 'tibial nerve success rate', 'anesthetic block duration', 'percentage of effective nerve blocks']","[{'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C0025384', 'cui_str': 'Mepivacaine'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}]",110.0,0.0376973,"No significant differences in absolute latency time ( p  = 0.287), percentage of effective nerve blocks ( p  = 0.634), anesthetic block duration ( p  = 0.895), or pain level during puncture ( p  = 0.847) were found between the two techniques.","[{'ForeName': 'María', 'Initials': 'M', 'LastName': 'Benimeli-Fenollar', 'Affiliation': 'Department of Nursing, University of Valencia, c/Jaume Roig s/n, 46010 Valencia, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Montiel-Company', 'Affiliation': 'Department of Stomatology, University of Valencia, c/Gascó Oliag, 1, 46010 Valencia, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Almerich-Silla', 'Affiliation': 'Department of Stomatology, University of Valencia, c/Gascó Oliag, 1, 46010 Valencia, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Cibrián', 'Affiliation': 'Department of Physiology, University of Valencia, c/Blasco Ibánez, 15, 46010 Valencia, Spain.'}, {'ForeName': 'Cecili', 'Initials': 'C', 'LastName': 'Macián-Romero', 'Affiliation': 'Department of Nursing, University of Valencia, c/Jaume Roig s/n, 46010 Valencia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17113860']
1296,32485945,"Sprint Interval Running and Continuous Running Produce Training Specific Adaptations, Despite a Similar Improvement of Aerobic Endurance Capacity-A Randomized Trial of Healthy Adults.","The purpose of the present study was to investigate training-specific adaptations to eight weeks of moderate intensity continuous training (CT) and sprint interval training (SIT). Young healthy subjects ( n  = 25; 9 males and 16 females) performed either continuous training (30-60 min, 70-80% peak heart rate) or sprint interval training (5-10 near maximal 30 s sprints, 3 min recovery) three times per week for eight weeks. Maximal oxygen consumption, 20 m shuttle run test and 5·60 m sprint test were performed before and after the intervention. Furthermore, heart rate, oxygen pulse, respiratory exchange ratio, lactate and running economy were assessed at five submaximal intensities, before and after the training interventions. Maximal oxygen uptake increased after CT (before: 47.9 ± 1.5; after: 49.7 ± 1.5 mL·kg -1 ·min -1 ,  p  < 0.05) and SIT (before: 50.5 ± 1.6; after: 53.3 ± 1.5 mL·kg -1 ·min -1 ,  p  < 0.01), with no statistically significant differences between groups. Both groups increased 20 m shuttle run performance and 60 m sprint performance, but SIT performed better than CT at the 4th and 5th 60 m sprint after the intervention ( p  < 0.05). At submaximal intensities, CT, but not SIT, reduced heart rate ( p  < 0.05), whereas lactate decreased in both groups. In conclusion, both groups demonstrated similar improvements of several performance measures including VO 2max , but sprint performance was better after SIT, and CT caused training-specific adaptations at submaximal intensities.",2020,"Both groups increased 20 m shuttle run performance and 60 m sprint performance, but SIT performed better than CT at the 4th and 5th 60 m sprint after the intervention ( p  < 0.05).","['Healthy Adults', 'Young healthy subjects ( n  = 25; 9 males and 16 females']","['continuous training', 'moderate intensity continuous training (CT) and sprint interval training (SIT', 'Sprint Interval Running and Continuous Running Produce Training Specific Adaptations', 'sprint interval training']","['Maximal oxygen consumption, 20 m shuttle run test and 5·60 m sprint test', 'lactate', 'Maximal oxygen uptake', 'heart rate', 'Furthermore, heart rate, oxygen pulse, respiratory exchange ratio, lactate and running economy', '20 m shuttle run performance and 60 m sprint performance', 'several performance measures including VO 2max , but sprint performance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",,0.025306,"Both groups increased 20 m shuttle run performance and 60 m sprint performance, but SIT performed better than CT at the 4th and 5th 60 m sprint after the intervention ( p  < 0.05).","[{'ForeName': 'Sigbjørn', 'Initials': 'S', 'LastName': 'Litleskare', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}, {'ForeName': 'Eystein', 'Initials': 'E', 'LastName': 'Enoksen', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Sandvei', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Støen', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}, {'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Stensrud', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}, {'ForeName': 'Egil', 'Initials': 'E', 'LastName': 'Johansen', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}]",International journal of environmental research and public health,['10.3390/ijerph17113865']
1297,32490838,The Use of a Smartphone App and an Activity Tracker to Promote Physical Activity in the Management of Chronic Obstructive Pulmonary Disease: Randomized Controlled Feasibility Study.,"BACKGROUND


Chronic obstructive pulmonary disease (COPD) is highly prevalent and significantly affects the daily functioning of patients. Self-management strategies, including increasing physical activity, can help people with COPD have better health and a better quality of life. Digital mobile health (mHealth) techniques have the potential to aid the delivery of self-management interventions for COPD. We developed an mHealth intervention (Self-Management supported by Assistive, Rehabilitative, and Telehealth technologies-COPD [SMART-COPD]), delivered via a smartphone app and an activity tracker, to help people with COPD maintain (or increase) physical activity after undertaking pulmonary rehabilitation (PR).
OBJECTIVE


This study aimed to determine the feasibility and acceptability of using the SMART-COPD intervention for the self-management of physical activity and to explore the feasibility of conducting a future randomized controlled trial (RCT) to investigate its effectiveness.
METHODS


We conducted a randomized feasibility study. A total of 30 participants with COPD were randomly allocated to receive the SMART-COPD intervention (n=19) or control (n=11). Participants used SMART-COPD throughout PR and for 8 weeks afterward (ie, maintenance) to set physical activity goals and monitor their progress. Questionnaire-based and physical activity-based outcome measures were taken at baseline, the end of PR, and the end of maintenance. Participants, and health care professionals involved in PR delivery, were interviewed about their experiences with the technology.
RESULTS


Overall, 47% (14/30) of participants withdrew from the study. Difficulty in using the technology was a common reason for withdrawal. Participants who completed the study had better baseline health and more prior experience with digital technology, compared with participants who withdrew. Participants who completed the study were generally positive about the technology and found it easy to use. Some participants felt their health had benefitted from using the technology and that it assisted them in achieving physical activity goals. Activity tracking and self-reporting were both found to be problematic as outcome measures of physical activity for this study. There was dissatisfaction among some control group members regarding their allocation.
CONCLUSIONS


mHealth shows promise in helping people with COPD self-manage their physical activity levels. mHealth interventions for COPD self-management may be more acceptable to people with prior experience of using digital technology and may be more beneficial if used at an earlier stage of COPD. Simplicity and usability were more important for engagement with the SMART-COPD intervention than personalization; therefore, the intervention should be simplified for future use. Future evaluation will require consideration of individual factors and their effect on mHealth efficacy and use; within-subject comparison of step count values; and an opportunity for control group participants to use the intervention if an RCT were to be carried out. Sample size calculations for a future evaluation would need to consider the high dropout rates.",2020,mHealth interventions for COPD self-management may be more acceptable to people with prior experience of using digital technology and may be more beneficial if used at an earlier stage of COPD.,"['Chronic obstructive pulmonary disease (COPD', '30 participants with COPD', 'Participants, and health care professionals involved in PR delivery, were interviewed about their experiences with the technology', 'Chronic Obstructive Pulmonary Disease', 'Participants who completed the study had better baseline health and more prior experience with digital technology, compared with participants who withdrew']","['SMART-COPD intervention', 'Smartphone App and an Activity Tracker to Promote Physical Activity']","['Simplicity and usability', 'Questionnaire-based and physical activity-based outcome measures']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}]","[{'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1454365', 'cui_str': 'Simplicity (adhesive)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}]",30.0,0.0578692,mHealth interventions for COPD self-management may be more acceptable to people with prior experience of using digital technology and may be more beneficial if used at an earlier stage of COPD.,"[{'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Bentley', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Powell', 'Affiliation': 'School of Education, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Potter', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Parker', 'Affiliation': 'School of Human Sciences, The University of Derby, Derby, United Kingdom.'}, {'ForeName': 'Gail A', 'Initials': 'GA', 'LastName': 'Mountain', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Yvonne Kiera', 'Initials': 'YK', 'LastName': 'Bartlett', 'Affiliation': 'Manchester Centre for Health Psychology, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Farwer', 'Affiliation': 'Library, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Cath', 'Initials': 'C', 'LastName': ""O'Connor"", 'Affiliation': 'Sheffield Teaching Hospitals NHS Foundation Trust, Integrated Community Care Team, Sheffield, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Burns', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Cresswell', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Heather D', 'Initials': 'HD', 'LastName': 'Dunn', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Hawley', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, United Kingdom.'}]",JMIR mHealth and uHealth,['10.2196/16203']
1298,32586139,Patients with Obesity Have Better Long-Term Outcomes after Hospitalization for COPD Exacerbation.,"Obesity has been shown to have a paradoxical benefit in a number of conditions, but the long-term effects in obesity after chronic obstructive pulmonary disease (COPD) exacerbation is still unclear. In this study, the effects of obesity on short- and long-term outcomes after a COPD exacerbation were evaluated. This was a secondary analysis of the Rapid Empiric Treatment with Oseltamivir Study (RETOS): a prospective, randomized, unblinded clinical trial. Patients were included in the study if they were hospitalized for acute exacerbation of COPD. Obesity was noted as patients with BMI >30. Clinical outcomes of time to clinical stability, length of stay, and mortality were compared. A total of 301 patients were included in the study, 122 (41%) patients were obese. There was no significant difference in the length of stay and time to clinical stability between patients with and without obesity. Mortality for patients with and without obesity was 3% and 3% at 30 days, 7% and 18% at six months, and 8% and 28% at one year, respectively. After adjusting with multivariable regression analysis, patients with obesity had a significant reduction in odds of dying at one year (adjusted odds ratio (aOR): 0.18; 95% CI: 0.06-0.58;  p  = .004) and at six months (aOR: 0.28; 95% CI: 0.09-0.89;  p  = .031). Our study showed that obesity was associated with reduced mortality at one year and six months after a COPD exacerbation. Although patients with obesity had higher rates of comorbidities, they had reduced mortality at one year after multivariable regression analysis.",2020,There was no significant difference in the length of stay and time to clinical stability between patients with and without obesity.,"['Patients were included in the study if they were hospitalized for acute exacerbation of COPD', 'A total of 301 patients were included in the study, 122 (41%) patients were obese', 'Patients with Obesity']",[],"['reduced mortality', 'Obesity', 'Mortality', 'time to clinical stability, length of stay, and mortality', 'length of stay and time to clinical stability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",[],"[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",301.0,0.17615,There was no significant difference in the length of stay and time to clinical stability between patients with and without obesity.,"[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'DeLapp', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Disorders Medicine, University of Louisville School of Medicine, Louisville, KY, USA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Glick', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Louisville School of Medicine, Louisville, KY, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Furmanek', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Louisville School of Medicine, Louisville, KY, USA.'}, {'ForeName': 'Julio A', 'Initials': 'JA', 'LastName': 'Ramirez', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Louisville School of Medicine, Louisville, KY, USA.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Cavallazzi', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Disorders Medicine, University of Louisville School of Medicine, Louisville, KY, USA.'}]",COPD,['10.1080/15412555.2020.1781805']
1299,32586176,"Re: Health Care Hotspotting-A Randomized, Controlled Trial.",,2020,,[],[],[],[],[],[],,0.217515,,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Resnick', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001171.02']
1300,32586177,Re: Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression among Men with Early-Stage Prostate Cancer: The MEAL Randomized Clinical Trial.,,2020,,['Men with Early-Stage Prostate Cancer'],['Behavioral Intervention to Increase Vegetable Consumption'],['Cancer Progression'],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0178874', 'cui_str': 'Tumor progression'}]",,0.0490649,,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Resnick', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001171']
1301,32586190,"Re: The Daily Therapy with L-Arginine 2,500 mg and Tadalafil 5 mg in Combination and in Monotherapy for the Treatment of Erectile Dysfunction: A Prospective, Randomized Multicentre Study.",,2020,,['Erectile Dysfunction'],"['L-Arginine 2,500 mg and Tadalafil 5 mg in Combination and in Monotherapy']",[],"[{'cui': 'C0242350', 'cui_str': 'Impotence'}]","[{'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C1331168', 'cui_str': 'tadalafil 5 MG'}]",[],,0.018511,,"[{'ForeName': 'Allen D', 'Initials': 'AD', 'LastName': 'Seftel', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001167.03']
1302,32588785,"Association between change in maternal physical activity during pregnancy and infant size, in a sample overweight or obese women.","Physical activity (PA) naturally declines during pregnancy and its effects on infant size are unclear, especially in overweight or obese pregnancies, a low-active subpopulation that tends deliver heavier infants. The objective of this study was to evaluate changes in prenatal PA and infant birthweight in a group of overweight or obese pregnant women. We employed a prospective analysis using data from a randomized controlled exercise trial (2001 to 2006) in sedentary, overweight or obese pregnant women in Michigan. Women with complete data on peak oxygen consumption, daily PA (via pedometers) and birthweight were included in the analyses. Change in PA was estimated via repeated measures analyses, and then its influence on infant birthweight was assessed via linear regression. Eighty-nine pregnant women were included and considered low-active (6,579.91 ± 2379.17 steps/day). PA declined from months 4 to 8 (-399.73 ± 371.38 steps∙day -1 ∙month -1 ). Analyses showed that the decline in PA (β = -0.28 g, 95%CI: -0.70, 0.25 g,  p  = .35) was not associated with birthweight. The findings of this study demonstrated that the decline in maternal PA during mid- to late-pregnancy, in overweight or obese women, was unrelated to infant birthweight. Future investigations should employ rigorous measurements of PA and infant anthropometry in this subpopulation.",2020,PA declined from months 4 to 8 (-399.73 ± 371.38 steps∙day -1 ∙month -1 ).,"['Eighty-nine pregnant women were included and considered low-active (6,579.91\xa0±\xa02379.17 steps/day', 'group of overweight or obese pregnant women', 'sample overweight or obese women', '2001 to 2006) in sedentary, overweight or obese pregnant women in Michigan']",[],"['peak oxygen consumption, daily PA (via pedometers) and birthweight', 'prenatal PA and infant birthweight', 'maternal PA', 'maternal physical activity']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}]",[],"[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",89.0,0.122053,PA declined from months 4 to 8 (-399.73 ± 371.38 steps∙day -1 ∙month -1 ).,"[{'ForeName': 'Samantha M', 'Initials': 'SM', 'LastName': 'McDonald', 'Affiliation': 'School of Dental Medicine, East Carolina University , Greenville, North Carolina, USA.'}, {'ForeName': 'SeonAe', 'Initials': 'S', 'LastName': 'Yeo', 'Affiliation': 'College of Nursing, University of North Carolina , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of South Carolina , Columbia, South Carolina, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wilcox', 'Affiliation': 'University of South Carolina , Columbia, SC, USA.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Sui', 'Affiliation': 'University of South Carolina , Columbia, SC, USA.'}, {'ForeName': 'Russell R', 'Initials': 'RR', 'LastName': 'Pate', 'Affiliation': 'University of South Carolina , Columbia, SC, USA.'}]",Women & health,['10.1080/03630242.2020.1779904']
1303,32584834,Gender-differences in predictors for time to metabolic syndrome resolution: A secondary analysis of a randomized controlled trial study.,"Understanding gender differences in health-related behaviors and their impacts is a crucial aspect of effective primary care. We studied gender-based differences in predictors of metabolic syndrome (MetS) resolution among newly diagnosed MetS patients. This study was a secondary analysis of a prospective clinical trial study comprising of 637 middle-aged and older adults (226 men and 411 women) who underwent a regular health checkup and were newly diagnosed with MetS at 16 different health clinics of 14 metropolitan cities and provinces. We conducted Cox proportional hazard analysis to estimate cumulative probability of MetS resolution within a 12-month observation period. Among the 637 patients, 47.6% of participants achieved MetS resolution. The resolution rate was similar among men and women (44.7% and 49.1%, respectively, P = 0.320). Low household income (Hazard ratio = 2.62, 95% confidence interval: 1.13-6.08) and current employment (2.29, 1.26-4.13) were associated with a higher cumulative probability of MetS resolution in men than in women. For women, however, longer sleeping hours (1.18, 1.04-1.34) and living with a partner (1.58, 1.06-2.35) were positive predictors of MetS resolution. Being overweight (0.63, 0.44-0.89) was associated with lower cumulative probability of MetS resolution in women than in men. The factors associated with cumulative probability of MetS resolution within the 12-month follow-up were different between men and women. These findings facilitate further exploration on gender-based differences in risk factors for less optimal improvements in MetS.",2020,"Low household income (Hazard ratio = 2.62, 95% confidence interval: 1.13-6.08) and current employment (2.29, 1.26-4.13) were associated with a higher cumulative probability of MetS resolution in men than in women.","['637 middle-aged and older adults (226 men and 411 women) who underwent a regular health checkup and were newly diagnosed with MetS at 16 different health clinics of 14 metropolitan cities and provinces', 'newly diagnosed MetS patients']",[],"['metabolic syndrome (MetS) resolution', 'current employment', 'cumulative probability of MetS resolution', 'MetS resolution', 'resolution rate']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0260860', 'cui_str': 'General medical examination'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",637.0,0.231571,"Low household income (Hazard ratio = 2.62, 95% confidence interval: 1.13-6.08) and current employment (2.29, 1.26-4.13) were associated with a higher cumulative probability of MetS resolution in men than in women.","[{'ForeName': 'Seung-Ah', 'Initials': 'SA', 'LastName': 'Choe', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, CHA University, Gyunggi-do, Republic of Korea.'}, {'ForeName': 'Nan-He', 'Initials': 'NH', 'LastName': 'Yoon', 'Affiliation': 'Department of Health Administration, Hanyang Cyber University, Seoul, Republic of Korea.'}, {'ForeName': 'Seunghyun', 'Initials': 'S', 'LastName': 'Yoo', 'Affiliation': 'Department of Public Health Science, Graduate School of Public Health, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Hyekyeong', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Health Convergence, Ewha Womans University, Seoul, Republic of Korea.'}]",PloS one,['10.1371/journal.pone.0234035']
1304,32584881,"Effect of maternal prenatal food supplementation, gestational weight gain, and breast-feeding on infant growth during the first 24 months of life in rural Vietnam.","Growth faltering among children during the first five years of life is a common problem among low and middle-income countries. The purpose of this study was to determine the effect of a nutrient-rich, food-based supplement given to Vietnamese rural women prior to and/or during pregnancy on the growth of their infants during first 24 months of life and to identify maternal and newborn factors associated with the infant's growth. This prospective cohort study included 236 infants born to mothers who had received nutritional advice or a food supplement from pre-conception to term or from mid-gestation to term as part of a prior randomized controlled trial. Infant anthropometry and feeding information were monitored monthly and the infant weight for age Z-score (WAZ), length for age Z-score (LAZ), and weight for length Z-score (WLZ) were assessed at 6, 12, 18, and 24 months of age using mixed-effects regression modeling. Compared to the non-supplemented mothers, infants born to mothers receiving food supplementation from mid-gestation to term had significantly higher WLZ only at 18 months (p = 0.03) and did not differ in other outcomes. Supplementation from pre-conception to term did not affect infant growth at any time point during the first 24 months. In the entire study cohort, maternal height and gestational weight gain were positively associated with the infant's WAZ and LAZ from 6 to 24 months of age. Programs designed to improve gestational weight gain among women performing demanding physical work throughout a reproductive cycle may improve postnatal infant growth. Trial registration: Registered Clinical Trials.Gov: NCT01235767.",2020,Supplementation from pre-conception to term did not affect infant growth at any time point during the first 24 months.,"['236 infants born to mothers who had received nutritional advice or a food supplement from pre-conception to term or from mid-gestation to term as part of a prior randomized controlled trial', 'rural Vietnam', ""Vietnamese rural women prior to and/or during pregnancy on the growth of their infants during first 24 months of life and to identify maternal and newborn factors associated with the infant's growth""]","['maternal prenatal food supplementation, gestational weight gain, and breast-feeding', 'nutrient-rich, food-based supplement']","['maternal height and gestational weight gain', 'infant weight for age Z-score (WAZ), length for age Z-score (LAZ), and weight for length Z-score (WLZ', 'WLZ', 'gestational weight gain']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",236.0,0.0761669,Supplementation from pre-conception to term did not affect infant growth at any time point during the first 24 months.,"[{'ForeName': 'Phi N', 'Initials': 'PN', 'LastName': 'Quyen', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Hoang T', 'Initials': 'HT', 'LastName': 'Nga', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Chaffee', 'Affiliation': 'University of California San Francisco, San Francisco, California, United States of America.'}, {'ForeName': 'Tu', 'Initials': 'T', 'LastName': 'Ngu', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Janet C', 'Initials': 'JC', 'LastName': 'King', 'Affiliation': ""Children's Hospital Oakland Research Institute, Oakland, California, United States of America.""}]",PloS one,['10.1371/journal.pone.0233671']
1305,32589630,Effect of tailoring anticoagulant treatment duration by applying a recurrence risk prediction model in patients with venous thromboembolism compared to usual care: A randomized controlled trial.,"BACKGROUND


Patients with unprovoked (i.e., without the presence of apparent transient risk factors such as recent surgery) venous thromboembolism (VTE) are at risk of recurrence if anticoagulants are stopped after 3-6 months, yet their risk remains heterogeneous. Thus, prolonging anticoagulant treatment should be considered in high-risk patients, whereas stopping is likely preferred in those with a low predicted risk. The Vienna Prediction Model (VPM) could aid clinicians in estimating this risk, yet its clinical effects and external validity are currently unknown. The aim of this study was to investigate the clinical impact of this model on reducing recurrence risk in patients with unprovoked VTE, compared to usual care.
METHODS AND FINDINGS


In a randomized controlled trial, the decision to prolong or stop anticoagulant treatment was guided by predicted recurrence risk using the VPM (n = 441), which was compared with usual care (n = 442). Patients with unprovoked VTE were recruited from local thrombosis services in the Netherlands (in Utrecht, Harderwijk, Ede, Amersfoort, Zwolle, Hilversum, Rotterdam, Deventer, and Enschede) between 22 July 2011 and 30 November 2015, with 24-month follow-up complete for all patients by early 2018. The primary outcome was recurrent VTE during 24 months of follow-up. Secondary outcomes included major bleeding and clinically relevant non-major (CRNM) bleeding. In the total study population of 883 patients, mean age was 55 years, and 507 (57.4%) were men. A total of 96 recurrent VTE events (10.9%) were observed, 46 in the intervention arm and 50 in the control arm (risk ratio 0.92, 95% CI 0.63-1.35, p = 0.67). Major bleeding occurred in 4 patients, 2 in each treatment arm, whereas CRNM bleeding occurred in 20 patients (12 in intervention arm versus 8 in control arm). The VPM showed good discriminative power (c-statistic 0.76, 95% CI 0.69-0.83) and moderate to good calibration, notably at the lower spectrum of predicted risk. For instance, in 284 patients with a predicted risk of >2% to 4%, the observed rate of recurrence was 2.5% (95% CI 0.7% to 4.3%). The main limitation of this study is that it did not enroll the preplanned number of 750 patients in each study arm due to declining recruitment rate.
CONCLUSIONS


Our results show that application of the VPM in all patients with unprovoked VTE is unlikely to reduce overall recurrence risk. Yet, in those with a low predicted risk of recurrence, the observed rate was also low, suggesting that it might be safe to stop anticoagulant treatment in these patients.
TRIAL REGISTRATION


Netherlands Trial Register NTR2680.",2020,"The VPM showed good discriminative power (c-statistic 0.76, 95% CI 0.69-0.83) and moderate to good calibration, notably at the lower spectrum of predicted risk.","['284 patients', '883 patients, mean age was 55 years, and 507 (57.4%) were men', 'patients with venous thromboembolism compared to usual care', 'Patients with unprovoked VTE were recruited from local thrombosis services in the Netherlands (in Utrecht, Harderwijk, Ede, Amersfoort, Zwolle, Hilversum, Rotterdam, Deventer, and Enschede) between 22 July 2011 and 30 November 2015, with 24-month follow-up complete for all patients by early 2018', 'patients with unprovoked VTE, compared to usual care']",[],"['CRNM bleeding', 'recurrence risk', 'recurrent VTE', 'major bleeding and clinically relevant non-major (CRNM) bleeding', 'overall recurrence risk', 'Major bleeding', 'rate of recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0450381', 'cui_str': '507'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",284.0,0.138641,"The VPM showed good discriminative power (c-statistic 0.76, 95% CI 0.69-0.83) and moderate to good calibration, notably at the lower spectrum of predicted risk.","[{'ForeName': 'Geert-Jan', 'Initials': 'GJ', 'LastName': 'Geersing', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Janneke M T', 'Initials': 'JMT', 'LastName': 'Hendriksen', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Nicolaas P A', 'Initials': 'NPA', 'LastName': 'Zuithoff', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Kit C', 'Initials': 'KC', 'LastName': 'Roes', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Ruud', 'Initials': 'R', 'LastName': 'Oudega', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Takada', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Roger E G', 'Initials': 'REG', 'LastName': 'Schutgens', 'Affiliation': 'Van Creveld Clinic, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Karel G M', 'Initials': 'KGM', 'LastName': 'Moons', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}]",PLoS medicine,['10.1371/journal.pmed.1003142']
1306,32589632,"A randomized controlled trial comparing the effectiveness of individual versus household treatment for Scabies in Lambaréné, Gabon.","BACKGROUND


It is unclear whether individual treatment of scabies is similarly effective compared to household treatment. This study compared these two treatment strategies with topical benzyl benzoate for treating scabies in Lambaréné, Gabon.
METHODS


Participants presenting with uncomplicated scabies were randomized into either the Individual Treatment group, where only the affected participants received treatment, or the Household Treatment group, where all family members were treated in parallel to the affected participants regardless of signs and symptoms. The primary endpoint was clinical cure after 28 days; the secondary endpoint was the proportion of affected household members per household after 28 days.
RESULTS


After 28 days, from a total of 79 participants assessed, 67% (n = 53) were clinically cured; 59% (20/34) in the Individual Treatment group and 73% (33/45) in the Household Treatment group. Participants in the Household Treatment group had about twice the odds of being cured (odds ratio 1.9, 95% confidence interval: 0.8-4.9; p = 0.17). For the secondary outcome, an effect of similar size was observed.
CONCLUSIONS


Our findings show that treating close contacts of persons affected by scabies may be beneficial to patients and contacts, however, the benefit was less pronounced than anticipated and further research is needed to definitively answer this question.",2020,"Participants in the Household Treatment group had about twice the odds of being cured (odds ratio 1.9, 95% confidence interval: 0.8-4.9; p = 0.17).",['Participants presenting with uncomplicated scabies'],['topical benzyl benzoate'],['clinical cure'],"[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0036262', 'cui_str': 'Infestation by Sarcoptes scabiei var hominis'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0053289', 'cui_str': 'benzyl benzoate'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}]",53.0,0.160026,"Participants in the Household Treatment group had about twice the odds of being cured (odds ratio 1.9, 95% confidence interval: 0.8-4.9; p = 0.17).","[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Matthewman', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}, {'ForeName': 'Rella Zoleko', 'Initials': 'RZ', 'LastName': 'Manego', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}, {'ForeName': 'Lia Betty', 'Initials': 'LB', 'LastName': 'Dimessa Mbadinga', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Šinkovec', 'Affiliation': 'Center for Medical Statistics, Informatics and Intelligent Systems, Institute of Clinical Biometrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Völker', 'Affiliation': 'Department of Tropical Medicine, Bernhard Nocht Institute for Tropical Medicine, & I Dep. of Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Malik', 'Initials': 'M', 'LastName': 'Akinosho', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Haedrich', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': ""Tardif d'Hamonville"", 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lell', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}, {'ForeName': 'Ayola Akim', 'Initials': 'AA', 'LastName': 'Adegnika', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ramharter', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}, {'ForeName': 'Ghyslain', 'Initials': 'G', 'LastName': 'Mombo-Ngoma', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008423']
1307,32589686,Optimal priming of poxvirus vector (NYVAC)-based HIV vaccine regimens for T cell responses requires three DNA injections. Results of the randomized multicentre EV03/ANRS VAC20 Phase I/II Trial.,"DNA vectors have been widely used as a priming of poxvirus vaccine in prime/boost regimens. Whether the number of DNA impacts qualitatively or quantitatively the immune response is not fully explored. With the aim to reinforce T-cell responses by optimizing the prime-boost regimen, the multicentric EV03/ANRS VAC20 phase I/II trial, randomized 147 HIV-negative volunteers to either 3xDNA plus 1xNYVAC (weeks 0, 4, 8 plus 24; n = 74) or to 2xDNA plus 2xNYVAC (weeks 0, 4 plus 20, 24; n = 73) groups. T-cell responses (IFN-γ ELISPOT) to at least one peptide pool were higher in the 3xDNA than the 2xDNA groups (91% and 80% of vaccinees) (P = 0.049). In the 3xDNA arm, 26 (37%) recipients developed a broader T-cell response (Env plus at least to one of the Gag, Pol, Nef pools) than in the 2xDNA (15; 22%) arms (primary endpoint; P = 0.047) with a higher magnitude against Env (at week 26) (P<0.001). In both groups, vaccine regimens induced HIV-specific polyfunctional CD4 and CD8 T cells and the production of Th1, Th2 and Th17/IL-21 cytokines. Antibody responses were also elicited in up to 81% of vaccines. A higher percentage of IgG responders was noted in the 2xDNA arm compared to the 3xDNA arm, while the 3xDNA group tended to elicit a higher magnitude of IgG3 response against specific Env antigens. We show here that the modulation of the prime strategy, without modifying the route or the dose of administration, or the combination of vectors, may influence the quality of the responses.",2020,T-cell responses (IFN-γ ELISPOT) to at least one peptide pool were higher in the 3xDNA than the 2xDNA groups (91% and 80% of vaccinees) (P = 0.049).,['147 HIV-negative volunteers to either'],"['poxvirus vector (NYVAC)-based HIV vaccine regimens', '3xDNA plus 1xNYVAC', '2xDNA plus 2xNYVAC']","['Antibody responses', 'IgG responders', 'HIV-specific polyfunctional CD4 and CD8 T cells and the production of Th1, Th2 and Th17/IL-21 cytokines', 'broader T-cell response', 'T-cell responses (IFN-γ ELISPOT', 'IgG3 response']","[{'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0032868', 'cui_str': 'Poxviridae'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0920508', 'cui_str': 'Enzyme linked immunospot assay'}, {'cui': 'C0020859', 'cui_str': 'Immunoglobulin IgG3'}]",147.0,0.0624733,T-cell responses (IFN-γ ELISPOT) to at least one peptide pool were higher in the 3xDNA than the 2xDNA groups (91% and 80% of vaccinees) (P = 0.049).,"[{'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Lévy', 'Affiliation': 'Vaccine Research Institute, Université Paris-Est Créteil, Faculté de Médecine, INSERM U955, équipe 16, Créteil, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lacabaratz', 'Affiliation': 'Vaccine Research Institute, Université Paris-Est Créteil, Faculté de Médecine, INSERM U955, équipe 16, Créteil, France.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Ellefsen-Lavoie', 'Affiliation': 'Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Stöhr', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, United Kingdom.'}, {'ForeName': 'Jean-Daniel', 'Initials': 'JD', 'LastName': 'Lelièvre', 'Affiliation': 'Vaccine Research Institute, Université Paris-Est Créteil, Faculté de Médecine, INSERM U955, équipe 16, Créteil, France.'}, {'ForeName': 'Pierre-Alexandre', 'Initials': 'PA', 'LastName': 'Bart', 'Affiliation': 'Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Launay', 'Affiliation': 'Université de Paris, Faculté de médecine Paris Descartes; Inserm, CIC 1417, F-CRIN I-REIVAC; Assistance Publique-Hôpitaux de Paris, CIC Cochin Pasteur, Paris, France.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Weber', 'Affiliation': 'Imperial College London, London, United Kingdom.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Salzberger', 'Affiliation': 'University Hospital, Institute of Clinical Microbiology and Hygiene, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Wiedemann', 'Affiliation': 'Vaccine Research Institute, Université Paris-Est Créteil, Faculté de Médecine, INSERM U955, équipe 16, Créteil, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Surenaud', 'Affiliation': 'Vaccine Research Institute, Université Paris-Est Créteil, Faculté de Médecine, INSERM U955, équipe 16, Créteil, France.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Koelle', 'Affiliation': 'Department of Medicine & Department of Global Health, University of Washington, Fred Hutchinson Cancer Research Center Seattle, Washington, United States of America.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Wolf', 'Affiliation': 'University Hospital, Institute of Clinical Microbiology and Hygiene, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Wagner', 'Affiliation': 'University Hospital, Institute of Clinical Microbiology and Hygiene, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Rieux', 'Affiliation': 'Vaccine Research Institute, Université Paris-Est Créteil, Faculté de Médecine, INSERM U955, équipe 16, Créteil, France.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Montefiori', 'Affiliation': 'Department of Surgery, Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, United States of America.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Yates', 'Affiliation': 'Department of Surgery, Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, United States of America.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Department of Surgery, Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, United States of America.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Gottardo', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Mayer', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Ding', 'Affiliation': 'EuroVacc Foundation, Lausanne, Switzerland.'}, {'ForeName': 'Rodolphe', 'Initials': 'R', 'LastName': 'Thiébaut', 'Affiliation': 'Inserm, Bordeaux Population Health Research Center, UMR 1219, University Bordeaux, ISPED, CIC 1401-EC, Univ Bordeaux, Bordeaux, France.'}, {'ForeName': 'Sheena', 'Initials': 'S', 'LastName': 'McCormack', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, United Kingdom.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Chêne', 'Affiliation': 'Inserm, Bordeaux Population Health Research Center, UMR 1219, University Bordeaux, ISPED, CIC 1401-EC, Univ Bordeaux, Bordeaux, France.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pantaleo', 'Affiliation': 'Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.'}]",PLoS pathogens,['10.1371/journal.ppat.1008522']
1308,32596938,Re: Incidence and characteristics of pregnancy-related death across ten low- and middle-income geographical regions: secondary analysis of a cluster randomised controlled trial: The underestimated scourge of eclampsia in low-income countries.,,2020,,[],[],[],[],[],[],,0.361711,,"[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Scioscia', 'Affiliation': 'Department of Obstetrics and Gynaecology, Policlinico Hospital, Abano Terme, Padua, Italy.'}, {'ForeName': 'Edgardo', 'Initials': 'E', 'LastName': 'Somigliana', 'Affiliation': ""Università degli Studi di Milano and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Sartie', 'Initials': 'S', 'LastName': 'Kenneh', 'Affiliation': 'Ministry of Health and Sanitation, Government of Sierra Leone, Freetown, Sierra Leone.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Robillard', 'Affiliation': ""Service de Néonatologie-Centre d'Etudes Périnatales Océan Indien (CEPOI), Centre Hospitalier Universitaire Sud Réunion, Saint-Pierre Cedex, La Réunion, France.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Dalle Carbonare', 'Affiliation': 'Department of Obstetrics and Gynaecology, Policlinico Hospital, Abano Terme, Padua, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Putoto', 'Affiliation': 'Operational Research Unit, Doctors with Africa CUAMM, Padua, Italy.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16351']
1309,32593547,Pegvaliase for the treatment of phenylketonuria: Results of the phase 2 dose-finding studies with long-term follow-up.,"BACKGROUND


Phenylketonuria (PKU) is characterized by a deficiency in phenylalanine hydroxylase (PAH) that may lead to elevated blood phenylalanine (Phe) and significant neurocognitive and neuropsychological comorbidities. Pegvaliase (PALYNZIQ®, BioMarin Pharmaceutical Inc.) is a PEGylated recombinant Anabaena variabilis phenylalanine ammonia lyase (PAL), which converts Phe to trans-cinnamic acid and ammonia, and was approved in May 2018 in the United States and in May 2019 in the European Union for decreasing blood Phe levels in adults with PKU with blood Phe levels >600 μmol/L. The efficacy and safety of pegvaliase was assessed in two phase 2 dose-finding studies in adults with PKU (PAL-002, NCT00925054, and PAL-004, NCT01212744). Participants completing these studies could enroll in a long-term extension study (PAL-003, NCT00924703).
METHODS


Participants in PAL-002 received pegvaliase 0.001, 0.003, 0.01, 0.03, or 0.1 mg/kg weekly for 8 weeks, then continued treatment for a further 8 weeks with dose and/or frequency adjusted to achieve blood Phe concentrations of 60 to 600 μmol/L. Participants in PAL-004 received pegvaliase 0.001 to 0.4 mg/kg 5 days/week for 13 weeks, with modifications made to the starting dose in response to safety and/or efficacy, followed by 3 additional weeks of follow-up assessments. The maximum allowable daily dose in both studies was 1.0 mg/kg/day (5.0 mg/kg/week). Participants who completed any of the phase 2 studies (PAL-002; PAL-004; or a third phase 2 study, 165-205) were eligible to enroll in an open-label, multicenter, long-term extension study (PAL-003, NCT00924703).
RESULTS


Thirty-seven of the 40 enrolled participants completed PAL-002 and 15 of the 16 enrolled participants completed PAL-004. Mean blood Phe at baseline was 1311.0 (standard deviation [SD] 354) μmol/L in PAL-002 and 1482.1 (SD 363.5) μmol/L in PAL-004. Mean blood Phe did not substantially decrease with pegvaliase treatment in PAL-002 (-206.3 [SD 287.1] μmol/L at Week 16) or PAL-004 (-410.8 [SD 653.7] μmol/L at Week 13). In PAL-004, mean blood Phe dropped from baseline by 929.1 μmol/L (SD 691.1) by Week 2; subsequent to dose modifications and interruptions, this early decrease in mean Phe level was not sustained. With increased pegvaliase dose and duration in PAL-003, mean blood Phe levels steadily decreased from baseline, with mean reductions by Week 120 of 68.8% (SD 44.2%) in PAL-002 participants and 75.9% (SD 32.4%) in PAL-004 participants. All participants in PAL-002 and PAL-004 reported ≥1 adverse event (AE), with higher exposure-adjusted event rates in PAL-004. The majority of AEs were mild (87.2% in PAL-002, 86.7% in PAL-004) or moderate (12.4% in PAL-002, 13.3% in PAL-004). The most commonly reported AEs in PAL-002 were injection site reaction (50.0% of participants), headache (42.1%), injection site erythema (36.8%), nausea (34.2%), and arthralgia (29.0%), and in PAL-004 were arthralgia (75.0%), headache (62.5%), dizziness (56.3%), injection site erythema (56.3%), and injection site reaction (50.0%).
CONCLUSIONS


In two phase 2 dose-finding studies, pegvaliase did not lead to substantial blood Phe reductions. Higher and more frequent pegvaliase dosing in PAL-004 led to a substantial initial drop in blood Phe, but an increase in the number of hypersensitivity AEs and dose reductions or interruptions. With increased dose and duration of treatment in PAL-003, mean blood Phe reduction was substantial and sustained, and the frequency of hypersensitivity AEs decreased and stabilized. Together, these studies led to the development of an induction-titration-maintenance regimen that has been approved for pegvaliase, with patients starting at a low weekly dose that gradually increases in dose and frequency until they achieve a standard non-weight-based daily maintenance dose. This regimen has been tested in a third phase 2 study, as well as in two successful phase 3 studies of pegvaliase.",2020,Mean blood Phe did not substantially decrease with pegvaliase treatment in PAL-002 (-206.3 [SD 287.1] μmol/L at Week 16) or PAL-004 (-410.8 [SD 653.7] μmol/L at Week 13).,"['Thirty-seven of the 40 enrolled participants completed PAL-002 and 15 of the 16 enrolled participants completed', 'adults with PKU with blood Phe levels', 'Participants who completed any of the phase 2 studies (PAL-002; PAL-004; or a third phase 2 study, 165-205) were eligible to enroll in an open-label, multicenter, long-term extension study (PAL-003, NCT00924703']",['PAL-004'],"['headache', 'dizziness', 'efficacy and safety of pegvaliase', 'frequency of hypersensitivity AEs', 'mean blood Phe', 'injection site reaction', 'pegvaliase dose and duration in PAL-003, mean blood Phe levels', 'nausea', 'arthralgia', 'injection site erythema', 'adverse event (AE', 'Mean blood Phe']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031454', 'cui_str': 'Phenylalanine ammonia-lyase'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0031485', 'cui_str': 'Phenylketonuria'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0428204', 'cui_str': 'Phenylalanine level - finding'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0031454', 'cui_str': 'Phenylalanine ammonia-lyase'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4519229', 'cui_str': 'pegvaliase'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0031454', 'cui_str': 'Phenylalanine ammonia-lyase'}, {'cui': 'C0428204', 'cui_str': 'Phenylalanine level - finding'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0852625', 'cui_str': 'Injection site erythema'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",40.0,0.118836,Mean blood Phe did not substantially decrease with pegvaliase treatment in PAL-002 (-206.3 [SD 287.1] μmol/L at Week 16) or PAL-004 (-410.8 [SD 653.7] μmol/L at Week 13).,"[{'ForeName': 'Barbara K', 'Initials': 'BK', 'LastName': 'Burton', 'Affiliation': ""Department of Pediatrics, Division of Genetics, Birth Defects & Metabolism, Ann & Robert H. Lurie Children's Hospital of Chicago, 225 E Chicago Ave, Chicago, IL 60611, United States of America. Electronic address: BBurton@luriechildrens.org.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Longo', 'Affiliation': 'Department of Pediatrics, Division of Medical Genetics, University of Utah, 295 Chipeta Way, Salt Lake City, UT 84108, United States of America. Electronic address: Nicola.Longo@hsc.utah.edu.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Vockley', 'Affiliation': ""Department of Pediatrics, Division of Medical Genetics, University of Pittsburgh and Children's Hospital of Pittsburgh, 4401 Penn Ave, Pittsburgh, PA 15224, United States of America. Electronic address: vockleyg@upmc.edu.""}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Grange', 'Affiliation': 'Department of Pediatrics, Division of Genetics and Genomic Medicine, Washington University, 660 S Euclid Ave, St. Louis, MO 63110, United States of America. Electronic address: grangedk@wustl.edu.'}, {'ForeName': 'Cary O', 'Initials': 'CO', 'LastName': 'Harding', 'Affiliation': 'Department of Molecular and Medical Genetics, Oregon Health & Science University, Portland, OR 97239, United States of America. Electronic address: hardingc@ohsu.edu.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Decker', 'Affiliation': 'Research and Development, BioMarin Pharmaceutical Inc., 105 Digital Dr, Novato, CA 94949, United States of America.'}, {'ForeName': 'Mingjin', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Research and Development, BioMarin Pharmaceutical Inc., 105 Digital Dr, Novato, CA 94949, United States of America. Electronic address: mili@bmrn.com.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Lau', 'Affiliation': 'Research and Development, BioMarin Pharmaceutical Inc., 105 Digital Dr, Novato, CA 94949, United States of America. Electronic address: klau@bmrn.com.'}, {'ForeName': 'Orli', 'Initials': 'O', 'LastName': 'Rosen', 'Affiliation': 'Research and Development, BioMarin Pharmaceutical Inc., 105 Digital Dr, Novato, CA 94949, United States of America. Electronic address: orli.rosen@bmrn.com.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Larimore', 'Affiliation': 'Research and Development, BioMarin Pharmaceutical Inc., 105 Digital Dr, Novato, CA 94949, United States of America. Electronic address: KLarimore@bmrn.com.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Thomas', 'Affiliation': 'Department of Pediatrics, Section of Clinical Genetics and Metabolism, University of Colorado School of Medicine, 12605 E 16th St, Aurora, CO 80045, United States of America. Electronic address: janet.thomas@childrenscolorado.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Molecular genetics and metabolism,['10.1016/j.ymgme.2020.06.006']
1310,32618267,"Adherence to Mass Drug Administration with Dihydroartemisinin-Piperaquine and  Plasmodium falciparum  Clearance in Southern Province, Zambia.","Mass drug administration (MDA) with artemisinin combination therapy is a potentially useful tool for malaria elimination programs, but its success depends partly on drug effectiveness and treatment coverage in the targeted population. As part of a cluster-randomized controlled trial in Southern Province, Zambia evaluating the impact of MDA and household focal MDA (fMDA) with dihydroartemisinin-piperaquine (DHAp), sub-studies were conducted investigating population drug adherence rates and effectiveness of DHAp as administered in clearing  Plasmodium falciparum  infections following household mass administration. Adherence information was reported for 181,534 of 336,821 DHAp (53.9%) treatments administered during four rounds of MDA/fMDA, of which 153,197 (84.4%) reported completing the full course of DHAp. The proportion of participants fully adhering to the treatment regimen differed by MDA modality (MDA versus fMDA), RDT status, and whether the first dose was observed by those administering treatments. Among a subset of participants receiving DHAp and selected for longitudinal follow-up, 58 were positive for asexual-stage  P. falciparum  infection by microscopy at baseline. None of the 45 participants followed up at days 3 and/or 7 were slide positive for asexual-stage parasitemia. For those with longer term follow-up, one participant was positive 47 days after treatment, and two additional participants were positive after 69 days, although these two were determined to be new infections by genotyping. High completion of a 3-day course of DHAp and parasite clearance in the context of household MDA are promising as Zambia's National Malaria Programme continues to weigh appropriate interventions for malaria elimination.",2020,None of the 45 participants followed up at days 3 and/or 7 were slide positive for asexual-stage parasitemia.,"['Southern Province, Zambia evaluating the impact of MDA and household focal MDA (fMDA) with', 'Southern Province, Zambia']","['Dihydroartemisinin-Piperaquine', 'DHAp', 'artemisinin combination therapy', 'dihydroartemisinin-piperaquine (DHAp']","['Adherence information', 'MDA modality (MDA versus fMDA), RDT status', 'slide positive for asexual-stage parasitemia']","[{'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}]","[{'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0206743', 'cui_str': 'Malignant rhabdoid tumor'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332246', 'cui_str': 'Sliding'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}]",,0.179382,None of the 45 participants followed up at days 3 and/or 7 were slide positive for asexual-stage parasitemia.,"[{'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Finn', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Travis R', 'Initials': 'TR', 'LastName': 'Porter', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Hawela', 'Initials': 'H', 'LastName': 'Moonga', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Chainama Hospital Grounds, Lusaka, Zambia.'}, {'ForeName': 'Kafula', 'Initials': 'K', 'LastName': 'Silumbe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Rachel F', 'Initials': 'RF', 'LastName': 'Daniels', 'Affiliation': 'The Broad Institute of MIT and Harvard, Cambridge, Massachusetts.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Volkman', 'Affiliation': 'Simmons University, Boston, Massachusetts.'}, {'ForeName': 'Joshua O', 'Initials': 'JO', 'LastName': 'Yukich', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Keating', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Steketee', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0667']
1311,32618279,"Safety and immunogenicity of a Zika purified inactivated virus vaccine given via standard, accelerated, or shortened schedules: a single-centre, double-blind, sequential-group, randomised, placebo-controlled, phase 1 trial.","BACKGROUND


The development of an effective vaccine against Zika virus remains a public health priority. A Zika purified inactivated virus (ZPIV) vaccine candidate has been shown to protect animals against Zika virus challenge and to be well tolerated and immunogenic in humans up to 8 weeks of follow-up. We aimed to assess the safety and immunogenicity of ZPIV in humans up to 52 weeks of follow-up when given via standard or accelerated vaccination schedules.
METHODS


We did a single-centre, double-blind, randomised controlled, phase 1 trial in healthy adults aged 18-50 years with no known history of flavivirus vaccination or infection at Beth Israel Deaconess Medical Center in Boston, MA, USA. Participants were sequentially enrolled into one of three groups: ZPIV given at weeks 0 and 4 (standard regimen), weeks 0 and 2 (accelerated regimen), or week 0 alone (single-dose regimen). Within each group, participants were randomly assigned using a computer-generated randomisation schedule to receive an intramuscular injection of 5 μg ZPIV or saline placebo, in a ratio of 5:1. The sponsor, clinical staff, investigators, participants, and laboratory personnel were masked to treatment assignment. The primary endpoint was safety up to day 364 after final dose administration, and secondary endpoints were proportion of participants with positive humoral immune responses (50% microneutralisation titre [MN 50 ] ≥100) and geometric mean MN 50  at observed peak response (ie, the highest neutralising antibody level observed for an individual participant across all timepoints) and week 28. All participants who received at least one dose of ZPIV or placebo were included in the safety population; the analysis of immunogenicity at observed peak included all participants who received at least one dose of ZPIV or placebo and had any adverse events or immunogenicity data after dosing. The week 28 immunogenicity analysis population consisted of all participants who received ZPIV or placebo and had immunogenicity data available at week 28. This trial is registered with ClinicalTrials.gov, NCT02937233.
FINDINGS


Between Dec 8, 2016, and May 17, 2017, 12 participants were enrolled into each group and then randomly assigned to vaccine (n=10) or placebo (n=2). There were no serious or grade 3 treatment-related adverse events. The most common reactions among the 30 participants who received the vaccine were injection-site pain (24 [80%]), fatigue (16 [53%]), and headache (14 [46%]). A positive response at observed peak titre was detected in all participants who received ZPIV via the standard regimen, in eight (80%) of ten participants who received ZPIV via the accelerated regimen, and in none of the ten participants who received ZPIV via the single-dose regimen. The geometric mean of all individual participants' observed peak values was 1153·9 (95% CI 455·2-2925·2) in the standard regimen group, 517·7 (142·9-1875·6) in the accelerated regimen group, and 6·3 (3·7-10·8) in the single-dose regimen group. At week 28, a positive response was observed in one (13%) of eight participants who received ZPIV via the standard regimen and in no participant who received ZPIV via the accelerated (n=7) or single-dose (n=10) regimens. The geomteric mean titre (GMT) at this timepoint was 13·9 (95% CI 3·5-55·1) in the standard regimen group and 6·9 (4·0-11·9) in the accelerated regimen group; antibody titres were undetectable at 28 weeks in participants who received ZPIV via the single-dose regimen. For all vaccine schedules, GMTs peaked 2 weeks after the final vaccination and declined to less than 100 by study week 16. There was no difference in observed peak GMTs between the standard 4-week and the accelerated 2-week boosting regimens (p=0·4494).
INTERPRETATION


ZPIV was safe and well tolerated in humans up to 52 weeks of follow-up. ZPIV immunogenicity required two doses and was not durable. Additional studies of ZPIV to optimise dosing schedules are ongoing.
FUNDING


The Henry M Jackson Foundation for the Advancement of Military Medicine.",2020,"There was no difference in observed peak GMTs between the standard 4-week and the accelerated 2-week boosting regimens (p=0·4494).
","['healthy adults aged 18-50 years with no known history of flavivirus vaccination or infection at Beth Israel Deaconess Medical Center in Boston, MA, USA']","['intramuscular injection of 5 μg ZPIV or saline placebo', 'ZPIV or placebo', 'Zika purified inactivated virus vaccine', 'vaccine', 'ZPIV', 'placebo']","['headache', 'Safety and immunogenicity', 'fatigue', 'ZPIV immunogenicity', 'geomteric mean titre (GMT', 'injection-site pain', 'adverse events or immunogenicity data', 'safety and immunogenicity', 'proportion of participants with positive humoral immune responses', 'serious or grade 3 treatment-related adverse events', ' antibody titres', 'geometric mean MN 50  at observed peak response (ie, the highest neutralising antibody level', 'positive response', 'peak titre', 'observed peak GMTs']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0016215', 'cui_str': 'Flavivirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0276289', 'cui_str': 'Zika virus disease'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0276289', 'cui_str': 'Zika virus disease'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0020967', 'cui_str': 'Humoral Immunity'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",12.0,0.542669,"There was no difference in observed peak GMTs between the standard 4-week and the accelerated 2-week boosting regimens (p=0·4494).
","[{'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Stephenson', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Chen Sabrina', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hale', 'Affiliation': 'University of Vermont Medical Center, Burlington, VT, USA; Larner College of Medicine, Burlington, VT, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Ansel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Diane G', 'Initials': 'DG', 'LastName': 'Kanjilal', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jaegle', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Peter', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Borducchi', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Nkolola', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Tatenda', 'Initials': 'T', 'LastName': 'Makoni', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Fogel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Bradshaw', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tyler', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Moseley', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Abishek', 'Initials': 'A', 'LastName': 'Chandrashekar', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Yanosick', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Seaman', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Eckels', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'De La Barrera', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Emmes, Rockville, MD, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dawson', 'Affiliation': 'Emmes, Rockville, MD, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Thomas', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Nelson L', 'Initials': 'NL', 'LastName': 'Michael', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Kayvon', 'Initials': 'K', 'LastName': 'Modjarrad', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA. Electronic address: dbarouch@bidmc.harvard.edu.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30085-2']
1312,32619848,The influence of placebo administration on the first- night effect in patients with insomnia disorder.,"OBJECTIVE


We aimed to investigate the effects of placebo on the first-night effect (FNE) in insomniacs.
METHODS


In sum, 36 patients with insomnia disorder who met the DSM-5 criteria were enrolled in this study. Sixteen patients with insomnia disorder were given two days of placebo intervention (placebo-administration group, PL). Twenty patients with insomnia disorder (drug-free group, DF) were not given any interventions. All participants underwent two consecutive nights of polysomnographic (PSG) testing in the sleep laboratory. Sleep diaries were recorded during one week at home before the PSG nights and on two subsequent nights.
RESULTS


The results demonstrated that compared with the DF group, sleep onset latency (SOL), time in bed (TIB) and wake after sleep onset (WASO) significantly increased and sleep efficiency (SE) significantly decreased in the first sleep lab night in the PL group (all p < 0.05). Moreover, compared with the second night, significant differences were observed in lower self-reported total sleep time (TST) and more subjective WASO during the first night in the PL group (all p < 0.05). However, no significant difference was found in the duration and percentage of N1, N2, N3 and REM between the two groups.
CONCLUSION


In patients with insomnia disorder, placebo administration may increase the occurrence of worse sleep without causing a change in the duration and percentage of N1, N2, N3 and REM on the first sleep lab night. In some cases, a placebo may not serve as treatment but may result in a nocebo effect.",2020,"However, no significant difference was found in the duration and percentage of N1, N2, N3 and REM between the two groups.
","['patients with insomnia disorder', 'Twenty patients with insomnia disorder (drug-free group, DF', 'All participants underwent two consecutive nights of polysomnographic (PSG) testing in the sleep laboratory', '36 patients with insomnia disorder who met the DSM-5 criteria', 'insomniacs', 'Sixteen patients with insomnia disorder']","['placebo intervention (placebo-administration group, PL', 'placebo']","['duration and percentage of N1, N2, N3 and REM', 'Sleep diaries', 'occurrence of worse sleep', 'lower self-reported total sleep time (TST) and more subjective WASO', 'sleep onset latency (SOL), time in bed (TIB) and wake after sleep onset (WASO', 'sleep efficiency (SE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0560134', 'cui_str': 'rem'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",36.0,0.0242769,"However, no significant difference was found in the duration and percentage of N1, N2, N3 and REM between the two groups.
","[{'ForeName': 'Sifan', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Yuezhen', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Neuropsychiatry, Behavioral Neurology and Sleep Center, Beijing Tian Tan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Shao', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Sijia', 'Initials': 'S', 'LastName': 'Lou', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Pan', 'Affiliation': 'Sleep Medicine Center, Suzhou Guangji Hospital, The Affiliated Guangji Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yao', 'Affiliation': 'Department of Physiology, College of Basic Medicine, Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Xiangdong', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Sleep Medicine Center, Department of Respiratory and Critical Care Medicine, Translational Neuroscience Center, State Key Laboratory, West China Hospital, Sichuan University, Chengdu, China. Electronic address: 2372564613@qq.com.'}, {'ForeName': 'Hongqiang', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China. Electronic address: sunhq@bjmu.edu.cn.'}]",Sleep medicine,['10.1016/j.sleep.2020.03.002']
1313,31829910,Diode Laser Vaporization for Benign Prostate Hyperplasia: Outcome After 126 Procedures.,"Purpose:  Photoselective vaporization of the prostate (PVP) with a 940-nm diode laser is an option for treating symptoms caused by benign prostatic hyperplasia (BPH). Here, we present our experience using this technology.  Methods:  We prospectively evaluated 126 patients with lower urinary tract symptoms (LUTS) secondary to BPH who underwent PVP with a 940-nm diode laser from January 2011 to January 2014. The patients were assessed using the International Prostate Symptom Score (IPSS), quality of life (QoL) score, prostate-specific antigen (PSA) level, maximum urinary flow (Qmax) by uroflowmetry, postvoid residual volume, and prostate volume by ultrasound at baseline and 3, 6, 12, and 24 months after the procedure.  Results:  The average patient age was 68.8 ± 8.7 years (range 48-90 years), whereas the average preoperative parameters were as follows: IPSS, 26.1 ± 5.2; IPSS-QoL, 4.9 ± 0.8; Qmax, 4.5 ± 3.1 mL/s; prostate volume, 76.5 ± 35.5 mL; and PSA level, 3.9 ± 2.6 ng/mL. The average catheterization time was 24.7 ± 25.5 hours (range 3-120 hours), and the length of hospital stay was 22.4 ± 17.0 hours (range 8-144 hours). The mean follow-up duration was 17.9 months (range 1-36 months). All parameters showed significant improvement after 12 months. After 24 months, the IPSS (8.8 ± 5.4,  p  < 0.07), IPSS-QoL (1.6 ± 0.9,  p  < 0.13), Qmax (15.9 ± 7.3 mL/s,  p  < 0.11), and PSA level (1.2 ± 0.8 ng/mL,  p  < 0.11) were improved compared with the baseline, but the difference was not significant, probably due to the small number of patients evaluated in this period. No patients required a transfusion.  Conclusions:  The results suggest that PVP with a 940-nm diode laser is safe, effective, and durable for the treatment of LUTS secondary to BPH. The patients continue to be monitored for evaluation of the long-term results. A prospective randomized study would allow more solid conclusions regarding the technology to be reached.",2019,"After 24 months, the IPSS (8.8 ± 5.4,  p  < 0.07), IPSS-QoL (1.6 ± 0.9,  p  < 0.13), Qmax (15.9 ± 7.3 mL/s,  p  < 0.11), and PSA level (1.2 ± 0.8 ng/mL,  p  < 0.11) were improved compared with the baseline, but the difference was not significant, probably due to the small number of patients evaluated in this period.","['benign prostatic hyperplasia (BPH', 'The average patient age was 68.8\u2009±\u20098.7 years (range 48-90 years), whereas the average preoperative parameters were as follows', '126 patients with lower urinary tract symptoms (LUTS) secondary to BPH who underwent PVP with a 940-nm diode laser from January 2011 to January 2014', 'Benign Prostate Hyperplasia']","['Diode Laser Vaporization', 'Photoselective vaporization of the prostate (PVP', 'PVP', '940-nm diode laser']","['International Prostate Symptom Score (IPSS), quality of life (QoL) score, prostate-specific antigen (PSA) level, maximum urinary flow (Qmax) by uroflowmetry, postvoid residual volume, and prostate volume by ultrasound', 'PSA level', 'average catheterization time', 'length of hospital stay', 'IPSS', 'IPSS-QoL']","[{'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0032856', 'cui_str': 'Povidone'}, {'cui': 'C4517905', 'cui_str': '940'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C1704272', 'cui_str': 'Benign prostatic hyperplasia'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0348007', 'cui_str': 'Laser Ablation'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0032856', 'cui_str': 'Povidone'}, {'cui': 'C4517905', 'cui_str': '940'}]","[{'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C0200008', 'cui_str': 'Uroflowmetry'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}]",126.0,0.0254412,"After 24 months, the IPSS (8.8 ± 5.4,  p  < 0.07), IPSS-QoL (1.6 ± 0.9,  p  < 0.13), Qmax (15.9 ± 7.3 mL/s,  p  < 0.11), and PSA level (1.2 ± 0.8 ng/mL,  p  < 0.11) were improved compared with the baseline, but the difference was not significant, probably due to the small number of patients evaluated in this period.","[{'ForeName': 'Eduardo Yukio', 'Initials': 'EY', 'LastName': 'Tanaka', 'Affiliation': 'Department of Urology, Hospital Brigadeiro, São Paulo, Brazil.'}, {'ForeName': 'Frederico Teixeira', 'Initials': 'FT', 'LastName': 'Barbosa', 'Affiliation': 'Department of Urology, Hospital Brigadeiro, São Paulo, Brazil.'}, {'ForeName': 'Claudio Bovolenta', 'Initials': 'CB', 'LastName': 'Murta', 'Affiliation': 'Department of Urology, Hospital Brigadeiro, São Paulo, Brazil.'}, {'ForeName': 'Joaquim Francisco', 'Initials': 'JF', 'LastName': 'Claro', 'Affiliation': 'Department of Urology, Hospital Brigadeiro, São Paulo, Brazil.'}, {'ForeName': 'Joao Padua', 'Initials': 'JP', 'LastName': 'Manzano', 'Affiliation': 'Department of Urology, Hospital Brigadeiro, São Paulo, Brazil.'}]",Journal of endourology,['10.1089/end.2019.0311']
1314,32586433,Group Intervention for Adolescent Anxiety and Depression: Outcomes of a Randomized Trial with Adolescents in Kenya.,"Youth mental health interventions in low-resource communities may benefit from including empirically supported elements, using stigma-free content, and using trained lay-providers. We developed and evaluated such an intervention, targeting adolescent depression and anxiety in Kenya, where mental health care is limited by social stigma and a paucity of providers. Kenyan adolescents (N = 51, ages 14-17, 60.78% female) from a school in an urban slum in Nairobi with self-reported moderate-to-severe symptoms of depression or anxiety were randomized to the 4-week ""Shamiri"" (""thrive"") group intervention or a study skills control intervention of equal duration. The Shamiri intervention included growth mindset, gratitude, and value affirmation exercises. The content was delivered by recent high school graduates (ages 17-21, 60% male) trained as lay-providers. Participants met in school once-a-week in groups of 9-12 youths (average group size 10). Compared to the study-skills control, Shamiri produced greater reductions in adolescent depression symptoms (p = .038; d = .32) and anxiety symptoms (p = .039; d = .54) from baseline to 4-week follow-up, and greater improvements in academic performance (p = .034; d = .32) from the school-term before versus after the intervention. There were no effects on overall social support or perceived control, but the Shamiri group showed larger increases in perceived social support from friends (p = .028, d = .71). This appears to be the first report that a brief, lay-provider delivered, community-based intervention may reduce internalizing symptoms and improve academic outcomes in high-symptom adolescents in Sub-Saharan Africa. Larger replications with extended follow-ups will help gauge the strength and durability of these effects.",2020,"Compared to the study-skills control, Shamiri produced greater reductions in adolescent depression symptoms (p = .038; d = .32) and anxiety symptoms (p = .039; d = .54) from baseline to 4-week follow-up, and greater improvements in academic performance (p = .034; d = .32) from the school-term before versus after the intervention.","['Participants met in school once-a-week in groups of 9-12 youths (average group size 10', 'Adolescents in Kenya', 'high-symptom adolescents in Sub-Saharan Africa', 'Kenyan adolescents (N\u202f=\u202f51, ages 14-17, 60.78% female) from a school in an urban slum in Nairobi with self-reported moderate-to-severe symptoms of depression or anxiety']","['4-week ""Shamiri"" (""thrive"") group intervention or a study skills control intervention of equal duration']","['anxiety symptoms', 'growth mindset, gratitude, and value affirmation exercises', 'overall social support', 'adolescent depression symptoms', 'academic performance', 'perceived social support']","[{'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0037345', 'cui_str': 'Slums'}, {'cui': 'C0027345', 'cui_str': 'Nairobi sheep virus disease'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C2938208', 'cui_str': 'Thrive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0871455', 'cui_str': 'Study Skills'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0333652,"Compared to the study-skills control, Shamiri produced greater reductions in adolescent depression symptoms (p = .038; d = .32) and anxiety symptoms (p = .039; d = .54) from baseline to 4-week follow-up, and greater improvements in academic performance (p = .034; d = .32) from the school-term before versus after the intervention.","[{'ForeName': 'Tom L', 'Initials': 'TL', 'LastName': 'Osborn', 'Affiliation': 'Harvard University; Shamiri Institute, Pittsfield, MA. Electronic address: osborn@shamiri.institute.'}, {'ForeName': 'Akash R', 'Initials': 'AR', 'LastName': 'Wasil', 'Affiliation': 'Harvard University; University of Pennsylvania.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Venturo-Conerly', 'Affiliation': 'Harvard University; Shamiri Institute, Pittsfield, MA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Schleider', 'Affiliation': 'Stony Brook University.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Weisz', 'Affiliation': 'Harvard University.'}]",Behavior therapy,['10.1016/j.beth.2019.09.005']
1315,32586434,"Be a Mom, a Web-Based Intervention to Prevent Postpartum Depression: Results From a Pilot Randomized Controlled Trial.","Be a Mom is a self-guided web-based intervention, grounded in cognitive behavioral therapy, delivered to postpartum women to prevent persistent postpartum depression [PPD] symptoms. We aimed to evaluate Be a Mom in terms of its preliminary efficacy, feasibility, and acceptability. A pilot randomized, two-arm controlled trial was conducted. Eligible women (presenting PPD risk-factors and/or early-onset PPD symptoms) were enrolled in the study and were randomly assigned to the intervention (Be a Mom) or to the waiting-list control group. Participants in both groups completed baseline (T1) and postintervention (T2) assessments. The 194 women presenting risk factors/early-onset PPD symptoms were allocated to the intervention (n = 98) or to the control (n = 96) group. A significant Time × Group interaction effect was found for both depressive and anxiety symptoms, with women in the intervention group presenting a larger decrease in symptoms from T1 to T2 (p < .05). Less than half of the women (41.8%) completed Be a Mom. Most women (71.4%) would use Be a Mom again if needed. Results provide preliminary evidence of the Be a Mom's efficacy, acceptability and feasibility, although further research is needed to establish Be a Mom as a selective/indicative preventive intervention for persistent PPD.",2020,"A significant Time × Group interaction effect was found for both depressive and anxiety symptoms, with women in the intervention group presenting a larger decrease in symptoms from T1 to T2 (p < .05).","['Eligible women (presenting PPD risk-factors and/or early-onset PPD symptoms', '194 women presenting risk factors/early-onset PPD symptoms']",['waiting-list control group'],['depressive and anxiety symptoms'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",194.0,0.154431,"A significant Time × Group interaction effect was found for both depressive and anxiety symptoms, with women in the intervention group presenting a larger decrease in symptoms from T1 to T2 (p < .05).","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Fonseca', 'Affiliation': 'CINEICC - Center for Research in Neuropsychology and Cognitive-Behavioral Intervention, University of Coimbra. Electronic address: anadfonseca@fpce.uc.pt.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Alves', 'Affiliation': 'CINEICC - Center for Research in Neuropsychology and Cognitive-Behavioral Intervention, University of Coimbra.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Monteiro', 'Affiliation': 'CINEICC - Center for Research in Neuropsychology and Cognitive-Behavioral Intervention, University of Coimbra.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Gorayeb', 'Affiliation': 'University of São Paulo.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Canavarro', 'Affiliation': 'CINEICC - Center for Research in Neuropsychology and Cognitive-Behavioral Intervention, University of Coimbra.'}]",Behavior therapy,['10.1016/j.beth.2019.09.007']
1316,32589156,Interactive Guidance Intervention to Address Sustained Social Withdrawal in Preterm Infants in Chile: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Preterm newborns can be exposed early to significant perinatal stress, and this stress can increase the risk of altered socioemotional development. Sustained social withdrawal in infants is an early indicator of emotional distress which is expressed by low reactivity to the environment, and if persistent, is frequently associated with altered psychological development. Infants born prematurely have a higher probability of developing sustained social withdrawal (adjusted odds ratio 1.84, 95% CI 1.04-3.26) than infants born full term, and there is a correlation between weight at birth and sustained social withdrawal at 12 months of age.
OBJECTIVE


The aims of this study are to compare the effect of the interactive guidance intervention to that of routine pediatric care on sustained social withdrawal in infants born moderately or late preterm and to explore the relationship between sustained social withdrawal in these infants and factors such as neonatal intensive care unit hospitalization variables, parental depression, and posttraumatic stress symptoms.
METHODS


This study is designed as a multicenter randomized controlled trial. Moderate and late preterm newborns and their parents were recruited and randomized (1:1 allocation ratio) to control and experimental groups. During neonatal intensive care unit hospitalization, daily duration of skin-to-skin contact, breastfeeding, and parental visits were recorded. Also, a daily score for neonatal pain and painful invasive procedures were recorded. After discharge from neonatal intensive care, for the duration of the study, both groups will attend follow-up consultations with neonatologists at 2, 6, and 12 months of age (corrected for gestational age) and will receive routine pediatric care. Every consultation will be recorded and assessed with the Alarm Distress Baby Scale to detect sustained social withdrawal (indicated by a score of 5 or higher). The neonatologists will perform an interactive guidance intervention if an infant in the intervention group exhibits sustained social withdrawal. In each follow-up consultation, parents will fill out the Edinburgh Postnatal Depression Scale, the modified Perinatal Posttraumatic Stress Disorder Questionnaire, and the Impact of Event Scale-revised.
RESULTS


Recruitment for this trial started in September 2017. As of May 2020, we have completed enrollment (N=110 infants born moderately or late preterm). We aim to publish the results by mid-2021.
CONCLUSIONS


This is the first randomized controlled trial with a sample of infants born moderately or late preterm infants who will attend pediatric follow-up consultations during their first year (corrected for gestational age at birth) with neonatologists trained in the Alarm Distress Baby Scale and who will receive this interactive guidance intervention. If successful, this early intervention will show significant potential to be implemented in both public and private health care, given its low cost of training staff and that the intervention takes place during routine pediatric follow-up.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03212547; https://clinicaltrials.gov/ct2/show/NCT03212547.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17943.",2020,"Infants born prematurely have a higher probability of developing sustained social withdrawal (adjusted odds ratio 1.84, 95% CI 1.04-3.26) than infants born full term, and there is a correlation between weight at birth and sustained social withdrawal at 12 months of age.
","['infants born moderately or late preterm', 'N=110 infants born moderately or late preterm', 'Moderate and late preterm newborns and their parents', 'infants born moderately or late preterm infants who will attend pediatric follow-up consultations during their first year (corrected for gestational age at birth) with neonatologists trained in the Alarm Distress Baby Scale and who will receive this', 'Preterm Infants in Chile', 'Preterm newborns']","['routine pediatric care', 'interactive guidance intervention', 'Interactive Guidance Intervention']","['higher probability of developing sustained social withdrawal', 'neonatal pain and painful invasive procedures', 'weight at birth and sustained social withdrawal', 'Edinburgh Postnatal Depression Scale, the modified Perinatal Posttraumatic Stress Disorder Questionnaire', 'daily duration of skin-to-skin contact, breastfeeding, and parental visits']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C3898619', 'cui_str': 'Late preterm infant'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0422322', 'cui_str': 'Follow-up consultation'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0456129', 'cui_str': 'Length of gestation at birth'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0008107', 'cui_str': 'Chile'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C3839839', 'cui_str': 'Pediatric care'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0424095', 'cui_str': 'Social withdrawal'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]",,0.149628,"Infants born prematurely have a higher probability of developing sustained social withdrawal (adjusted odds ratio 1.84, 95% CI 1.04-3.26) than infants born full term, and there is a correlation between weight at birth and sustained social withdrawal at 12 months of age.
","[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Bustamante Loyola', 'Affiliation': 'Neonatology Unit, Clinica Alemana de Santiago, Santiago, Chile.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Perez Retamal', 'Affiliation': 'Neonatology Unit, Clinica Alemana de Santiago, Santiago, Chile.'}, {'ForeName': 'Monica Isabel', 'Initials': 'MI', 'LastName': 'Morgues Nudman', 'Affiliation': 'Neonatology Unit, Hospital San Jose, Santiago, Chile.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Maturana', 'Affiliation': 'Neonatology Unit, Clinica Alemana de Santiago, Santiago, Chile.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Salinas Gonzalez', 'Affiliation': 'Neonatology Unit, Clinica Alemana de Santiago, Santiago, Chile.'}, {'ForeName': 'Horacio', 'Initials': 'H', 'LastName': 'Cox', 'Affiliation': 'Neonatology Unit, Clinica Alemana de Santiago, Santiago, Chile.'}, {'ForeName': 'José Miguel', 'Initials': 'JM', 'LastName': 'González Mas', 'Affiliation': 'Neonatology Unit, Clinica Alemana de Santiago, Santiago, Chile.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Muñoz', 'Affiliation': 'Neonatology Unit, Hospital San Jose, Santiago, Chile.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Lopez', 'Affiliation': 'Neonatology Unit, Hospital San Jose, Santiago, Chile.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Mendiburo-Seguel', 'Affiliation': 'Faculty of Education and Social Sciences, Universidad Andrés Bello, Santiago, Chile.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Simó', 'Affiliation': 'Faculty of Psychology, Universitat de Valencia, Valencia, Spain.'}, {'ForeName': 'Pascual', 'Initials': 'P', 'LastName': 'Palau Subiela', 'Affiliation': 'Spain Association for Infant Mental Health Since Gestation, Valencia, Spain.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Guedeney', 'Affiliation': 'Hospital Bichat Claude Bernard, Assistance Publique-Hôpitaux de Paris, Paris, France.'}]",JMIR research protocols,['10.2196/17943']
1317,31832821,Incidence of peripheral neuropathy associated with eribulin mesylate versus vinorelbine in patients with metastatic breast cancer: sub-group analysis of a randomized phase III study.,"BACKGROUND


Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most significant neurologic complications of chemotherapy, impacting patient's behavior and quality of life. CIPN is mostly sensory, with rare incidences of autonomic dysfunction and other neuropathy.
METHODS


We conducted a single-center sub-group analysis of patients with metastatic breast cancer enrolled in a phase III study (NCT02225470) set up to compare eribulin mesylate (1.4 mg/m 2  on days 1 and 8 every 21 days) with vinorelbine (25 mg/m 2  on days 1, 8, and 15 every 21 days). The analysis investigated incidence of peripheral neuropathy, time to onset of neuropathy, and safety.
RESULTS


Our analysis included 110 women with a mean age of 50.7 (SD = 10.9). The median accumulated dose of eribulin was 11.2 mg/m 2  and 125.0 mg/m 2  for vinorelbine. Among patients in the eribulin group, a performance status (ECOG PS) of 2 was correlated with peripheral sensory neuropathy (p = 0.015), and accumulated eribulin dose (≥ 10 mg/m 2 ) was associated with all neuropathy and peripheral sensory neuropathy (p = 0.003 and p = 0.007, respectively). In the vinorelbine group, patient age (≥ 65 years) was positively associated with all neuropathy (p = 0.043). The time to onset of neuropathy appeared to be longer for eribulin versus vinorelbine (35.3 vs. 34.6 weeks; p = 0.046), with a significantly higher incidence of autonomic neuropathy at weeks 2 and 10 observed among patients receiving vinorelbine (p = 0.008 and p = 0.043, respectively).
CONCLUSION


Vinorelbine is associated with a higher incidence of autonomic neuropathy than eribulin in patients with metastatic breast cancer. Furthermore, the onset of neurotoxicity appears to occur earlier with vinorelbine than eribulin.",2020,Vinorelbine is associated with a higher incidence of autonomic neuropathy than eribulin in patients with metastatic breast cancer.,"['patients with metastatic breast cancer', '110 women with a mean age of 50.7 (SD = 10.9', 'patients with metastatic breast cancer enrolled in a phase III study (NCT02225470) set up to compare eribulin mesylate ']","['Vinorelbine', 'vinorelbine', 'eribulin mesylate versus vinorelbine']","['performance status (ECOG PS', 'autonomic neuropathy', 'peripheral neuropathy, time to onset of neuropathy, and safety', 'peripheral sensory neuropathy', 'time to onset of neuropathy', 'neuropathy and peripheral sensory neuropathy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C2608038', 'cui_str': 'Eribulin mesylate'}]","[{'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C2608038', 'cui_str': 'Eribulin mesylate'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}, {'cui': 'C0259749', 'cui_str': 'Autonomic neuropathy'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}]",110.0,0.0360162,Vinorelbine is associated with a higher incidence of autonomic neuropathy than eribulin in patients with metastatic breast cancer.,"[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Medical Oncology, Changzheng Hospital, Second Military Medical University, Shanghai, 200003, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Biyun', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Xichun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 200032, China. xchu2009@hotmail.com.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05112-5']
1318,31834519,Effects of ginger adjunct to the standard prophylaxis on reducing carboplatin and paclitaxel-induced nausea vomiting: a randomized controlled study.,"PURPOSE


To determine effects of ginger on reducing the severity of nausea and/or vomiting among gynecologic cancer patients receiving a combined carboplatin-paclitaxel regimen.
METHODS


The research was a randomized, double-blinded, crossover, placebo-controlled trial. Participants were patients with gynecologic malignancies receiving carboplatin-paclitaxel chemotherapy at King Chulalongkorn Memorial Hospital. Either ginger (2 g per day) or placebo was prescribed in adjunct to standard antiemetic prophylaxis, in alternated cycles between groups: in group 1, ginger was prescribed in odd cycles and placebo in even cycles and vice versa in group 2. Patients with gut obstruction or brain or bowel metastasis, those using anticoagulants or other ginger or antiemetic medications, or patients who had ginger allergy were excluded from the study. Statistics were analyzed by STATA version 15.1.
RESULTS


Overall, 47 participants were recruited. Mean age was 53.9 years. Seventeen subjects were chemotherapy-naïve. In an acute phase of nausea, ginger therapy significantly reduced the mean nausea score comparing to placebo (P = 0.03). However, in the delayed phase, there were no significant differences between groups. For the acute and delayed phase of vomiting, there was no difference between the groups. No serious adverse effects were demonstrated in the ginger group (P > 0.05).
CONCLUSION


Adjunct ginger therapy on standard nausea and vomiting prophylaxis protocol especially in day 1 has benefit in reducing an acute phase nausea in patients receiving a combined carboplatin-paclitaxel regimen. The benefit on delayed phase nausea and vomiting is still equivocal.",2020,"In an acute phase of nausea, ginger therapy significantly reduced the mean nausea score comparing to placebo (P = 0.03).","['patients receiving a combined carboplatin-paclitaxel regimen', 'gynecologic cancer patients receiving a combined carboplatin-paclitaxel regimen', 'Patients with gut obstruction or brain or bowel metastasis, those using anticoagulants or other ginger or antiemetic medications, or patients who had ginger allergy were excluded from the study', '47 participants were recruited', 'Seventeen subjects were chemotherapy-naïve', 'at King Chulalongkorn Memorial Hospital', 'Participants were patients with gynecologic malignancies receiving', 'Mean age was 53.9 years']","['carboplatin and paclitaxel', 'carboplatin-paclitaxel chemotherapy', 'placebo']","['nausea vomiting', 'nausea and/or vomiting', 'mean nausea score', 'vomiting', 'acute phase nausea', 'serious adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0162751', 'cui_str': 'Ginger'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439557', 'cui_str': 'Acute phase'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",47.0,0.284531,"In an acute phase of nausea, ginger therapy significantly reduced the mean nausea score comparing to placebo (P = 0.03).","[{'ForeName': 'Apiradee', 'Initials': 'A', 'LastName': 'Uthaipaisanwong', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Shina', 'Initials': 'S', 'LastName': 'Oranratanaphan', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand. dr_shina@hotmail.com.'}, {'ForeName': 'Natdanai', 'Initials': 'N', 'LastName': 'Musigavong', 'Affiliation': 'Department of Pharmacy, Chaophya Abhaibhubejhr Hospital, Prachin Buri, Thailand.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05201-5']
1319,32590653,Keeping the Finger on the Pulse: Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia with Adrenaline.,"BACKGROUND


The wide-awake local anesthesia no tourniquet (WALANT) technique in hand surgery is gaining popularity. The authors aimed to prospectively analyze the frequency and type of arrhythmias in patients undergoing hand surgery under local anesthesia and to examine whether the addition of adrenaline affects their incidence.
METHODS


Adult patients undergoing hand surgery under local anesthesia were randomized into two groups: group 1, local anesthesia with lidocaine and tourniquet; and group 2, local anesthesia with lidocaine and adrenaline (WALANT). Patients with a history of arrhythmias were excluded. Patients were connected to Holter electrocardiographic monitoring before surgery and up until discharge. The records were blindly compared between the groups regarding types of arrhythmias, and frequency and timing relative to injection and tourniquet inflation.
RESULTS


One hundred two patients were included between August of 2018 and August of 2019 (age, 59.7 ± 13.6 years; 71 percent women; 51 in each group). No major arrhythmia (ventricular tachycardia, ventricular fibrillation, atrial fibrillation) or arrhythmia-related symptoms were recorded for either group. Minor arrhythmias (including atrial premature beats, ventricular premature beats, and atrial tachycardia) were recorded in 68 patients (66.6 percent), with no statistical difference between the groups. There were three patients with minor arrhythmias during inflation of the tourniquet. Patients in the adrenaline group had 2 percent sinus tachycardia during injection and 4 percent asymptomatic bradyarrhythmias. These findings do not require any further treatment.
CONCLUSIONS


The authors' results show that hand operations using WALANT technique in patients with no history of arrhythmia are safe and are not arrhythmogenic; therefore, there is no need for routine perioperative continuous electrocardiographic monitoring.
CLINICAL QUESTION/LEVEL OF EVIDENCE


Therapeutic, II.",2020,"No major arrhythmia (ventricular tachycardia, ventricular fibrillation, atrial fibrillation) or arrhythmia-related symptoms were recorded for either group.","['One hundred two patients were included between August of 2018 and August of 2019 (age, 59.7 ± 13.6 years; 71 percent women; 51 in each group', 'Patients with a history of arrhythmias were excluded', 'Adult patients undergoing hand surgery under local anesthesia', 'patients undergoing hand surgery under local anesthesia']","['adrenaline', 'Adrenaline', 'local anesthesia with lidocaine and tourniquet; and group 2, local anesthesia with lidocaine and adrenaline (WALANT']","['Minor arrhythmias (including atrial premature beats, ventricular premature beats, and atrial tachycardia', 'sinus tachycardia', 'major arrhythmia (ventricular tachycardia, ventricular fibrillation, atrial fibrillation) or arrhythmia-related symptoms']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0187067', 'cui_str': 'Operative procedure on hand'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0234422', 'cui_str': 'Awake'}]","[{'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033036', 'cui_str': 'Atrial premature complex'}, {'cui': 'C0151636', 'cui_str': 'Ventricular premature beats'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}, {'cui': 'C0039239', 'cui_str': 'Sinus tachycardia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0042514', 'cui_str': 'Ventricular tachycardia'}, {'cui': 'C0042510', 'cui_str': 'Ventricular fibrillation'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",3.0,0.0466821,"No major arrhythmia (ventricular tachycardia, ventricular fibrillation, atrial fibrillation) or arrhythmia-related symptoms were recorded for either group.","[{'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Farkash', 'Affiliation': 'Ashdod and Beer-Sheva, Israel From the Hand Surgery Unit, the Department of Orthopedic Surgery, and the Electrophysiology and Pacing Unit, Cardiology Department, Assuta Ashdod University Hospital; and the Faculty of Health Sciences, Ben-Gurion University of the Negev.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Herman', 'Affiliation': ''}, {'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Kalimian', 'Affiliation': ''}, {'ForeName': 'Ohad', 'Initials': 'O', 'LastName': 'Segal', 'Affiliation': ''}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Avishag', 'Initials': 'A', 'LastName': 'Laish-Farkash', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006902']
1320,32593046,"An open-label, multicentre, randomized comparative study of efficacy, safety and tolerability of the 5 plant - extract BNO 1012 in the Delayed Antibiotic Prescription Method in children, aged 6 to 11 years with acute viral and post-viral rhinosinusitis.","Acute rhinosinusitis (ARS) can be characterized as bacterial (ABRS) and require antibiotic therapy only in 0.5-5% of cases. In most cases, the disease is in a viral and post-viral form, which requires pathogenetic and symptomatic treatment. The study objective was to determine the efficacy of BNO 1012 extract in the technology of delayed antibiotic prescribing in children with acute rhinosinusitis.
METHODS


292 children aged 6 to 11 years with ARS were randomized in the multicenter, comparative study. They received an extract of five medicinal plants in addition to standard symptomatic therapy or standard therapy only. EVALUATION CRITERIA: reduction of the sinusitis severity according to a 4-point medical assessment scale (nasal congestion, severity of anterior and posterior rhinorrhea) at each visit, dynamics of self-scoring of rhinorrhea and headache (according to a 10-point visual analogue scale), ""therapeutic benefit"" in days, frequency of antibiotic prescriptions due to the use of an extract of five plants.
RESULTS


The use of the 5-plant extract BNO 1012 in addition to the standard symptomatic treatment of acute rhinosinusitis provides a clinically significant, adequate reduction in the severity of rhinorrhea, nasal congestion and post-nasal drip, assessed by a physician at V2 (p < 0.005). Significant differences are noted in the patient's self-scoring of rhinorrhea on the second or third day in viral RS, and from the fourth to the eighth day in post-viral RS. Symptoms of similar intensity in control group were observed at V3. Thus, in the first week of treatment, the treatment group compared to the control one showed a ""therapeutic benefit"" of three days. The use of BNO 1012 in patients with acute rhinosinusitis can 1.81-fold reduce the prescription of antibacterial drugs.
CONCLUSION


The combination of five medicinal plants is effective for the treatment of acute rhinosinusitis in children aged 6 to 11 years. Its use provides a significant ""therapeutic benefit"" when administered in addition to standard symptomatic therapy, reducing the need for antibiotic use.",2020,The combination of five medicinal plants is effective for the treatment of acute rhinosinusitis in children aged 6 to 11 years.,"['children, aged 6 to 11\u202fyears with acute viral and post-viral rhinosinusitis', '292 children aged 6 to 11\u202fyears with ARS', 'children with acute rhinosinusitis', 'Acute rhinosinusitis (ARS', 'patients with acute rhinosinusitis', 'acute rhinosinusitis in children aged 6 to 11\u202fyears']",['5 plant - extract BNO'],"['efficacy, safety and tolerability', ""patient's self-scoring of rhinorrhea"", 'severity of rhinorrhea, nasal congestion and post-nasal drip']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032081', 'cui_str': 'Plant extract'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C0032781', 'cui_str': 'Posterior rhinorrhea'}]",292.0,0.0255448,The combination of five medicinal plants is effective for the treatment of acute rhinosinusitis in children aged 6 to 11 years.,"[{'ForeName': 'Vasyl I', 'Initials': 'VI', 'LastName': 'Popovych', 'Affiliation': 'ENT - Department of Ivano-Frankivsk National Medical University, Halytska Street, 2, Ivano-Frankivsk, Ivano-Frankivsk Region 76000, Ukraine. Electronic address: popovych_ent@ukr.net.'}, {'ForeName': 'Halyna V', 'Initials': 'HV', 'LastName': 'Beketova', 'Affiliation': 'Department of Children and Adolescent Diseases of the National Academy of Postgraduate Education, 9, Dorogozhytska Street, Kyiv 04112, Ukraine.'}, {'ForeName': 'Ivana V', 'Initials': 'IV', 'LastName': 'Koshel', 'Affiliation': 'Department of Therapy and Family Medicine of Institute of Postgraduate Education of Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Halytska Street, 2, Ivano-Frankivsk, Ivano-Frankivsk Region 76000, Ukraine.'}, {'ForeName': 'Olha A', 'Initials': 'OA', 'LastName': 'Tsodikova', 'Affiliation': 'Department of Outpatient Pediatrics KhMAPE, 58 Amosova Street, Kharkiv, Kharkiv Region 61176, Ukraine.'}, {'ForeName': 'Tetiana A', 'Initials': 'TA', 'LastName': 'Kriuchko', 'Affiliation': 'Department of Pediatrics №2 of Ukrainian Dental Academy, European Street, 39, Poltava, Poltava Region 36011, Ukraine.'}, {'ForeName': 'Aleksandr E', 'Initials': 'AE', 'LastName': 'Abaturov', 'Affiliation': 'Department of Pediatrics and Medical Genetics of Dnipropetrovsk Medical Academy, Volodymyra Vernadskoho Street, 9, Dnipro, Dnipropetrovsk Region 49044, Ukraine.'}, {'ForeName': 'Liudmyla I', 'Initials': 'LI', 'LastName': 'Vakulenko', 'Affiliation': 'Department of Pediatrics No. 2, Dnipropetrovsk Medical Academy, Volodymyra Vernadskoho Street, 9, Dnipro, Dnipropetrovsk Region 49044, Ukraine.'}, {'ForeName': 'Iurii V', 'Initials': 'IV', 'LastName': 'Gavrylenko', 'Affiliation': 'Department of Pediatric Otolaryngology of the National Academy of the Postgraduate Education, 9, Dorogozhytska Street, Kyiv 04112, Ukraine.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102564']
1321,32593123,Quality of life changes in response to yoga therapy in patients with schizophrenia: Reanalysis of Three randomized controlled trials.,,2020,,['patients with schizophrenia'],['yoga therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}]",[],,0.0595902,,"[{'ForeName': 'Saeko', 'Initials': 'S', 'LastName': 'Ikai-Tani', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan; Faculty of Kinesiology & Physical Education, University of Toronto, 55 Harbord Street, M5S 2W6, Toronto, ON, Canada. Electronic address: sako0609@gmail.com.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Tani', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan; Kimel Family Translational Imaging-Genetics Laboratory, Centre for Addiction and Mental Health, 1001 Queen St W, M6J 1H4, Toronto, ON, Canada.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Kamiyama', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Mimura', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Uchida', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan; Geriatric Mental Health Program, Centre for Addiction and Mental Health, 1001 Queen St W, M6J 1H4, Toronto, ON, Canada.'}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.102250']
1322,32593717,Caring for older veterans with chronic low back pain using a geriatric syndrome approach: Rationale and methods for the aging back clinics (ABC) trial.,"The purpose of the ongoing trial is to improve care of older Veterans with chronic low back pain (CLBP, i.e., low back pain for ≥6 months on ≥ half the days). Current CLBP care is limited by being either overly spine-focused or non-specifically prescribed and both approaches frequently lead to suboptimal reduction in pain and improvement in function. Through prior studies we have laid the foundation for a patient-centered approach to care for older Veterans with CLBP in which the spine is a source of vulnerability but not the sole treatment target. The approach considers CLBP a geriatric syndrome, a final common pathway for the expression of multiple contributors rather than a disease of the spine. We describe here the rationale and design of a randomized controlled trial to test the efficacy of an older Veteran-centered approach to CLBP care in ""Aging Back Clinics (ABCs)"" compared with Usual Care (UC). Three hundred thirty Veterans age 65-89 with CLBP will be randomized to ABCs or UC and followed for 12 months after randomization. We will assess the impact of ABCs on our primary outcome of pain-associated disability with the Oswestry Disability Index at 6 and 12 months, and secondary outcomes of pain intensity, health-related quality of life, balance confidence, mobility and healthcare utilization. If shown efficacious, the approach tested in ABCs has the potential to transform the care of older adults with CLBP by improving the quality of life for millions, reducing morbidity and saving substantial healthcare costs.",2020,"If shown efficacious, the approach tested in ABCs has the potential to transform the care of older adults with CLBP by improving the quality of life for millions, reducing morbidity and saving substantial healthcare costs.","['Three hundred thirty Veterans age 65-89 with CLBP', 'older Veterans with chronic low back pain (CLBP, i.e., low back pain for ≥6\u202fmonths on ≥ half the days', 'older veterans with chronic low back pain using a geriatric syndrome approach', 'older adults with CLBP']","['ABCs or UC', 'older Veteran-centered approach to CLBP care', 'Usual Care (UC']","['pain-associated disability with the Oswestry Disability Index', 'pain intensity, health-related quality of life, balance confidence, mobility and healthcare utilization']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",330.0,0.0631505,"If shown efficacious, the approach tested in ABCs has the potential to transform the care of older adults with CLBP by improving the quality of life for millions, reducing morbidity and saving substantial healthcare costs.","[{'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Weiner', 'Affiliation': 'Geriatric Research, Education and Clinic Center, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America; University of Pittsburgh School of Medicine, Pittsburgh, PA, United States of America. Electronic address: debra.weiner@va.gov.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Gentili', 'Affiliation': 'Central Virginia VA Health Care System, Richmond, VA, United States of America; Virginia Commonwealth University Health System, Richmond, VA.'}, {'ForeName': 'Meika A', 'Initials': 'MA', 'LastName': 'Fang', 'Affiliation': 'Geriatric Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States of America; David Geffen School of Medicine at UCLA Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Garay', 'Affiliation': 'VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Thiru', 'Initials': 'T', 'LastName': 'Annaswamy', 'Affiliation': 'VA North Texas Health Care System, Dallas, TX, United States of America; University of Texas Southwestern Medical Center, Dallas, TX, United States of America.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Castle', 'Affiliation': 'Geriatric Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States of America; David Geffen School of Medicine at UCLA Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Lenore', 'Initials': 'L', 'LastName': 'Joseph', 'Affiliation': 'Central Virginia VA Health Care System, Richmond, VA, United States of America; Virginia Commonwealth University Health System, Richmond, VA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lawson', 'Affiliation': 'Central Virginia VA Health Care System, Richmond, VA, United States of America; Virginia Commonwealth University Health System, Richmond, VA.'}, {'ForeName': 'Cathy C', 'Initials': 'CC', 'LastName': 'Lee', 'Affiliation': 'Geriatric Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States of America; David Geffen School of Medicine at UCLA Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Una E', 'Initials': 'UE', 'LastName': 'Makris', 'Affiliation': 'VA North Texas Health Care System, Dallas, TX, United States of America; University of Texas Southwestern Medical Center, Dallas, TX, United States of America.'}, {'ForeName': 'Michelle I', 'Initials': 'MI', 'LastName': 'Rossi', 'Affiliation': 'Geriatric Research, Education and Clinic Center, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America; University of Pittsburgh School of Medicine, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Thorn', 'Affiliation': 'University of Alabama, Tuscaloosa, AL, United States of America.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Clemens', 'Affiliation': 'Geriatric Research, Education and Clinic Center, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Newman', 'Affiliation': 'Geriatric Research, Education and Clinic Center, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Subashan', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, United States of America; University of Pittsburgh Graduate School of Public Health, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106077']
1323,32593753,Correlation between effectual time and the curative effect in patients with all frequency descending sudden deafness after treatment.,"OBJECTIVE


To discuss the correlation between effectual time and the curative effect in patients with all frequency descending sudden deafness.
METHODS


According to effectual time, the subjects were divided into first week effectual group and second week effectual group and the curative effect of each group was compared.
RESULTS


In patients with flat descent sudden deafness, the curative rate of the first week effectual group was higher than that of the second week effectual group, but there was no significant difference between the two groups (χ 2  = 1.584, P = 0.208). Meanwhile, the total significant effective rate of the first week effectual group was higher than that of the second week effectual group, without obvious difference between the two groups (χ 2  = 0.227, P = 0.634). Furthermore, in patients with total deafness type of sudden deafness, the curative rate of the first week effectual group was higher than that of the second week effectual group, showing no remarkable difference between the two groups (χ 2  = 2.726, P = 0.099). Besides, there was no remarkable difference in the comparison of the total significant effective rate (χ 2  = 2.933, P = 0.087), which was higher in the first week effectual group than that in the second week effectual group.
CONCLUSION


The course of treatment should be at least 2 weeks in patients with all frequency descending sudden deafness after onset.",2020,"Besides, there was no remarkable difference in the comparison of the total significant effective rate (χ 2  = 2.933, P = 0.087), which was higher in the first week effectual group than that in the second week effectual group.
","['patients with all frequency descending sudden deafness after treatment', 'patients with all frequency descending sudden deafness']",[],"['curative rate', 'total significant effective rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C1148477', 'cui_str': 'Sudden Deafness'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}]",[],"[{'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.014918,"Besides, there was no remarkable difference in the comparison of the total significant effective rate (χ 2  = 2.933, P = 0.087), which was higher in the first week effectual group than that in the second week effectual group.
","[{'ForeName': 'Jian-Ping', 'Initials': 'JP', 'LastName': 'Si', 'Affiliation': 'Handan Central Hospital, Handan, Hebei 056000, China. Electronic address: sjpemail@126.com.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Handan Central Hospital, Handan, Hebei 056000, China.'}, {'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Li', 'Affiliation': 'Handan Central Hospital, Handan, Hebei 056000, China.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102621']
1324,32594612,Safety and tolerability of elbasvir/grazoprevir in chronic hepatitis C virus therapy: Integrated analysis from clinical trials.,"Direct-acting antiviral treatments for chronic hepatitis C virus (HCV) infection are generally safe; however, understanding the safety profile of each regimen is essential for their continued use. Safety data were pooled from 12 clinical trials of elbasvir/grazoprevir (EBR/GZR) that enrolled adult participants with HCV infection. Pooled analyses are presented for participants receiving EBR/GZR for 12 weeks and those receiving EBR/GZR plus ribavirin (RBV) for 16-18 weeks. Safety data are also presented for participants with comorbidities receiving EBR/GZR for 12 weeks in individual clinical trials (chronic kidney disease [CKD] stage 4/5, inherited blood disorders [IBLD] or receiving opioid agonist therapy [OAT]). Among 1743 participants receiving EBR/GZR for 12 weeks, 1068 (61.3%) reported ≥1 adverse event (AE) and 491 had AEs (28.2%) considered drug-related. The most frequent AEs were headache (10.6%), fatigue (8.7%), nasopharyngitis (5.8%), nausea (5.1%) and diarrhoea (5.0%). Serious AEs were reported by 37 participants (2.1%), and 12 (0.7%) discontinued treatment due to an AE. In populations with CKD 4/5 or IBLD or receiving OAT, safety was similar in participants receiving EBR/GZR for 12 weeks and those receiving placebo. Some AEs occurred at higher frequencies in participants receiving RBV compared with those receiving EBR/GZR alone: fatigue (32.7% vs 8.7%); headache (21.6% vs 10.6%); and nausea (15.8% vs 5.1%). Safety was similar in participants with and those without cirrhosis. Grade 3/4 alanine aminotransferase elevations were reported in 0.7% participants. EBR/GZR is a safe treatment option for individuals with HCV genotype (GT) 1 or GT4 infections, even those with challenging comorbidities such as CKD or IBLD and those receiving OAT.",2020,"EBR/GZR is a safe treatment option for individuals with HCV genotype (GT)1 or GT4 infections, even those with challenging comorbidities such as CKD or IBLD and in those receiving OAT.","['participants with comorbidities receiving EBR/GZR for 12 weeks in individual clinical trials (chronic kidney disease [CKD] stage 4/5, inherited blood disorders [IBLD', '1743 participants receiving', 'participants with and those without cirrhosis', 'enrolled adult participants with HCV infection']","['opioid agonist therapy [OAT', 'Direct-acting antiviral treatments', 'EBR/GZR plus ribavirin (RBV', 'elbasvir/grazoprevir', 'EBR/GZR', 'elbasvir/grazoprevir (EBR/GZR', 'placebo']","['headache', 'diarrhea', 'Safety and tolerability', 'Safety', 'fatigue', '≥1 adverse event (AE', 'IBLD or receiving OAT, safety', 'Grade 3/4 alanine aminotransferase elevations', 'nasopharyngitis', 'nausea']","[{'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C4080453', 'cui_str': 'elbasvir and grazoprevir'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0018939', 'cui_str': 'Disorder of hematopoietic system'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0028753', 'cui_str': 'Oats'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C2363964', 'cui_str': 'Antiviral treatment'}, {'cui': 'C4080453', 'cui_str': 'elbasvir and grazoprevir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0028753', 'cui_str': 'Oats'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",1743.0,0.0643241,"EBR/GZR is a safe treatment option for individuals with HCV genotype (GT)1 or GT4 infections, even those with challenging comorbidities such as CKD or IBLD and in those receiving OAT.","[{'ForeName': 'Gayatri', 'Initials': 'G', 'LastName': 'Nangia', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Vierling', 'Affiliation': 'Departments of Medicine and Surgery, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kwo', 'Affiliation': 'Department of Medicine-Gastroenterology and Hepatology, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Deborah D', 'Initials': 'DD', 'LastName': 'Brown', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Stephanie O', 'Initials': 'SO', 'LastName': 'Klopfer', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Robertson', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Haber', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'K Rajender', 'Initials': 'KR', 'LastName': 'Reddy', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, PA, USA.'}]",Journal of viral hepatitis,['10.1111/jvh.13357']
1325,32683755,First-trimester screening based on cell-free DNA vs combined screening: A randomized clinical trial on women's experience.,"OBJECTIVE


To compare women's experience of first-trimester combined screening (FTCS), with women's experience of an approach that uses the combination of a detailed early anatomy scan and cell-free DNA (cfDNA) analysis.
METHODS


This was single-center, open label, parallel group, randomized clinical trial. Pregnant women were randomized at the time of their first prenatal visit to either a policy of first-trimester risk assessment based on FTCS, or to a policy of first-trimester risk assessment based on ultrasound findings and cfDNA. FTCS included ultrasound evaluation with crown-rump length, nuchal translucency (NT) measurement, and a detailed ultrasound scan, along with biochemistry (PAPP-A and free beta hCG). In this group, invasive diagnostic testing was offered to patients with risk >1 in 100, or NT >3.5 mm, or any fetal abnormalities on ultrasound. Women randomized in the intervention group received an approach of first-trimester risk assessment based on ultrasound findings and cfDNA. cfDNA analysis included a simultaneous microarray-based assay of non-polymorphic (chromosomes 13, 18, 21, X and Y) and polymorphic loci to estimate chromosome proportion and fetal fraction. In the intervention group, invasive diagnostic testing was offered to patients with abnormal cfDNA screening results, or NT >3.5 mm, or any fetal abnormalities on ultrasound. Participants received pre-test and post-test questionnaires regarding to measure reassurance, satisfaction, and anxiety. The primary outcome was the post-test reassurance, defined as mean score of reassurance post-test questionnaire. The effect of the assigned screening test on the mean of each outcome was quantified as mean difference (MD) with 95% confidence interval (CI).
RESULTS


Forty women with singleton gestations were enrolled in the trial. Mean score for reassurance was significantly higher in the cfDNA group compared to the FTCS group in the pre-test questionnaire (MD 0.80 points, 95% CI 0.27 to 1.33) and in the post-test questionnaire (MD 16.50 points, 95% CI 2.18 to 30.82). Women randomized to the cfDNA group had higher satisfaction and lower mean anxiety score as assessed in the STAI pre-test questionnaire.
CONCLUSIONS


First-trimester risk assessment for fetal aneuploidy with a combination of a detailed ultrasound examination and cfDNA is associated with better maternal reassurance and better maternal satisfaction compared to the standard first-trimester combined screening with nuchal translucency, and biochemistry.
TRIAL REGISTRATION


Clinicaltrials.gov NCT04077060.",2020,"Women randomized to the cfDNA group had higher satisfication and lower mean anxiety score as assessed in the STAI pre-test questionnaire.
","['Pregnant women', '40 women with singleton gestations', ""women's experience""]","['cfDNA', 'first-trimester combined screening (FTCS', 'FTCS', 'approach of first-trimester risk assessment based on ultrasound findings and cfDNA', 'First-trimester screening based on cell-free DNA vs combined screening', 'policy of first-trimester risk assessment based on FTCS, or to a policy of first-trimester risk assessment based on ultrasound findings and cfDNA']","['ultrasound evaluation with crown-rump length, nuchal translucency (NT) measurement', 'Mean score for reassurance', 'maternal reassurance and better maternal satisfaction', 'post-test reassurance, defined as mean score of reassurance post-test questionnaire', 'mean anxiety score']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C4289789', 'cui_str': 'Cell free DNA'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1299966', 'cui_str': 'Ultrasound scan finding'}, {'cui': 'C0242456', 'cui_str': 'Policy'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C2825540', 'cui_str': 'Crown rump length'}, {'cui': 'C1449855', 'cui_str': 'Nuchal Fold'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0204558', 'cui_str': 'Group reassurance'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",40.0,0.147153,"Women randomized to the cfDNA group had higher satisfication and lower mean anxiety score as assessed in the STAI pre-test questionnaire.
","[{'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Migliorini', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Saccone', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Fiora', 'Initials': 'F', 'LastName': 'Silvestro', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Massaro', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Arduino', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': ""D'Alessandro"", 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Petti', 'Affiliation': 'Department of Molecular Medicine and Medical Biotechnologies, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Jessica Anna Cinzia', 'Initials': 'JAC', 'LastName': 'Paino', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Guida', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Mariavittoria', 'Initials': 'M', 'LastName': 'Locci', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Fulvio', 'Initials': 'F', 'LastName': 'Zullo', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}]",Prenatal diagnosis,['10.1002/pd.5800']
1326,32602170,Genetic Variant in CHRNA5 and Response to Varenicline and Combination Nicotine Replacement in a Randomized Placebo-Controlled Trial.,"It is unclear if genetic variants affect smoking cessation treatment response. This study tested whether variants in the cholinergic receptor nicotinic alpha 5 subunit (CHRNA5) predict response to smoking cessation medication by directly comparing the two most effective smoking cessation pharmacotherapies. In this genotype-stratified randomized, double-blind, placebo-controlled clinical trial (May 2015-August 2019 in St Louis, Missouri), smokers were randomized by genotype in blocks of six (1:1:1 ratio) to three conditions: 12 weeks of placebo (n = 273), combination nicotine patch and lozenge (combination nicotine replacement therapy, cNRT, n = 275), or varenicline (n = 274). All participants received counseling and were followed for 12 months. The primary end point was biochemically verified 7-day point prevalence abstinence at the end of treatment (EOT, week 12). Trial registration and eligibility criteria are on clinicaltrials.gov (https://clinicaltrials.gov/) (NCT02351167). We conducted the genetic analyses separately for 516 European ancestry (EA) smokers and 306 non-EA smokers (including 270 African American smokers). In African American smokers, there was a genotype-by-treatment interaction for EOT abstinence (χ 2   = 10.7, degrees of freedom = 2. P = 0.0049): specifically, cNRT was more effective in smokers with rs16969968 GG genotype than was placebo, while varenicline was more effective in smokers of GA/AA genotypes. In EA ancestry smokers, there was no significant genotype-by-treatment interaction. In the whole sample, although both were effective at EOT, only varenicline, and not cNRT, was significantly effective relative to placebo at 6-month follow-up. Importantly, this study suggests that genetic information can further enhance smoking cessation treatment effectiveness.",2020,"In the whole sample, only varenicline, and not cNRT, produced higher abstinence at 6-month follow-up.","['African American smokers', '516 European American (EA) smokers and 306 non-EA smokers (including 270 African American smokers']","['varenicline, and not cNRT', 'placebo', 'cholinergic receptor nicotinic alpha 5 subunit (CHRNA5', 'Varenicline and Combination Nicotine Replacement', 'varenicline', 'combination nicotine patch and lozenge (cNRT, n=275), or varenicline', 'cNRT']",['7-day point prevalence abstinence'],"[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319603', 'cui_str': '270'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034792', 'cui_str': 'Cholinergic receptor'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",,0.197091,"In the whole sample, only varenicline, and not cNRT, produced higher abstinence at 6-month follow-up.","[{'ForeName': 'Li-Shiun', 'Initials': 'LS', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bray', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Smock', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Jingling', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Stoneking', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Culverhouse', 'Affiliation': 'John T. Milliken Department of Medicine, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Saccone', 'Affiliation': 'Department of Genetics, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Christopher I', 'Initials': 'CI', 'LastName': 'Amos', 'Affiliation': 'Department of Biomedical Data Science, Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Carney', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Jorenby', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Bierut', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1971']
1327,32602557,Prevention of adhesive capsulitis following pacemaker implantation: A randomized controlled study.,"INTRODUCTION


Gradual painful loss of active and passive range of motion in shoulder joint was introduced as adhesive capsulitis (AC). Disabilities in patients with AC are absenteeism from work, loss to leisure time, and recurrent seeking to health care services. The aim of this study was to evaluate the incidence of AC following pacemaker implementation. The effect of physical therapy and exercise education was also evaluated to prevent AC following pacemaker implementation.
METHODS


This study is a randomized clinical controlled trial. It was conducted on 62 pacemaker candidates. Patients with no shoulder pain and without any motion limits were enrolled in the study consecutively. The patients randomly were divided into two groups after pacemaker implementation. One group was treated with physical therapy (group A, n = 28) and the other group did not (group B, n = 34). The incidence of AC was assessed in both groups after 4 months.
RESULTS


A total of 62 patients were enrolled in the study. The mean age was 63.2 ± 12.1 years in the group A and 67.1 ± 17.6 years in the group B. Age was not significantly different between groups. A total of 11 patients (17.7%) had AC 16 weeks after the initial visit (two patients in group A and nine patients in group B; P = .004).
CONCLUSIONS


Incidence of AC is 17.7% following device implantation. Exercise education and physical therapy significantly reduces AC incidence following pacemaker implantation.",2020,Exercise education and physical therapy significantly reduces adhesive capsulitis incidence following pacemaker implantation.,"['Patients with no shoulder pain and without any motion limits were enrolled the study consecutively', 'pacemaker implantation', '62 patients were enrolled in the study']","['physical therapy and exercise education', 'Exercise education and physical therapy', 'physical therapy']","['incidence of adhesive capsulitis', 'adhesive capsulitis incidence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0582396', 'cui_str': 'Exercise education'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0158300', 'cui_str': 'Capsulitis, Adhesive'}]",62.0,0.0523918,Exercise education and physical therapy significantly reduces adhesive capsulitis incidence following pacemaker implantation.,"[{'ForeName': 'Mohammad Vahid', 'Initials': 'MV', 'LastName': 'Jorat', 'Affiliation': 'Cardiovascular Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Seyedeh Mahdieh', 'Initials': 'SM', 'LastName': 'Namayandeh', 'Affiliation': 'Cardiovascular Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mehdipour Namdar', 'Affiliation': 'Cardiovascular Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Aslani', 'Affiliation': 'Cardiovascular Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Pacing and clinical electrophysiology : PACE,['10.1111/pace.13999']
1328,32627073,"A randomized, double-blind, parallel-group, single‑dose, pharmacokinetic bioequivalence study of INTP24 and bevacizumab in healthy adult men.","PURPOSE


To demonstrate pharmacokinetic (PK) equivalence and to compare safety of INTP24 (bevacizumab biosimilar) with that of US-bevacizumab and EU-bevacizumab in healthy male subjects.
METHODS


In this randomized, parallel-group, double-blind study, male subjects were randomized (1:1:1) to receive a single 1 mg/kg intravenous infusion of either INTP24, US-bevacizumab, or EU-bevacizumab. The primary endpoint was area under serum concentration (AUC) from time zero to infinity (AUC 0-∞ ). Secondary endpoints were AUC from time zero to last quantifiable concentration (AUC 0-t ), maximum concentration (C max ), other PK parameters, immunogenicity, and safety.
RESULTS


A total of 117 subjects (39/group) were dosed; 113 subjects (37, 37, and 39 in INPT24, US-bevacizumab, and EU-bevacizumab groups, respectively) completed the study and were included in the PK analysis. Baseline demographics were similar across the three groups. The 90% confidence intervals (CI) of geometric mean ratios (GMR) of ln-transformed AUC 0-∞  and C max  of INTP24 relative to US-bevacizumab and EU-bevacizumab were within the acceptance range of 80%-125% (INTP24 vs. US-bevacizumab, 96.55-112.51% and 99.16-112.79%: INTP24 vs. EU-bevacizumab, 94.84-110.17% and 96.32-109.28%). The 90% CIs of GMRs for AUC 0-t  was also within 80-125% for INTP24 vs. US-bevacizumab and INTP24 vs. EU-bevacizumab. Safety and immunogenicity profiles were similar across the three groups. Twenty-one (17.95%) subjects experienced at least one AE and 9 (7.69%) were ADA positive. One treatment-related serious adverse event (varicella zoster infection) was reported in INTP24 group.
CONCLUSION


This study demonstrated PK bioequivalence of INTP24 to US-bevacizumab and EU-bevacizumab in healthy male subjects and showed similar safety and immunogenicity profiles across the treatment groups.",2020,This study demonstrated PK bioequivalence of INTP24 to US-bevacizumab and EU-bevacizumab in healthy male subjects and showed similar safety and immunogenicity profiles across the treatment groups.,"['male subjects', 'healthy adult men', 'healthy male subjects', '117 subjects (39/group) were dosed; 113 subjects (37, 37, and 39 in', 'groups, respectively) completed the study and were included in the PK analysis']","['INPT24, US-bevacizumab, and EU-bevacizumab', 'INTP24 to US-bevacizumab and EU-bevacizumab', 'INTP24, US-bevacizumab, or EU-bevacizumab', 'INTP24 vs. US-bevacizumab and INTP24 vs. EU-bevacizumab', 'INTP24', 'INTP24 and bevacizumab', 'bevacizumab', 'bevacizumab biosimilar) with that of US-bevacizumab and EU-bevacizumab']","['AUC from time zero to last quantifiable concentration (AUC 0-t ), maximum concentration (C max ), other PK parameters, immunogenicity, and safety', 'serious adverse event (varicella zoster infection', 'confidence intervals (CI) of geometric mean ratios (GMR) of ln-transformed AUC 0-∞  and C max  of INTP24 relative to US-bevacizumab and EU-bevacizumab', 'Safety and immunogenicity profiles', 'ADA positive', 'area under serum concentration (AUC) from time zero to infinity (AUC 0-∞ ', 'pharmacokinetic (PK) equivalence']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0586989', 'cui_str': 'Varicella-zoster virus infection'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0001457', 'cui_str': 'Adenosine deaminase'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",117.0,0.205122,This study demonstrated PK bioequivalence of INTP24 to US-bevacizumab and EU-bevacizumab in healthy male subjects and showed similar safety and immunogenicity profiles across the treatment groups.,"[{'ForeName': 'Inderjeet', 'Initials': 'I', 'LastName': 'Singh', 'Affiliation': 'Intas Pharmaceuticals Ltd. (Biopharma Division), Plot No: 423/P/A, Sarkhej-Bavla Highway, Moraiya, Sanand, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': 'Ronak', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Lambda Therapeutic Research Ltd., Lambda House, Plot No. 38, Survey No. 388, Near Silver Oak Club, S. G. Highway, Gota, Ahmedabad, Gujarat, 382481, India.'}, {'ForeName': 'Akash', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Lambda Therapeutic Research Ltd., Lambda House, Plot No. 38, Survey No. 388, Near Silver Oak Club, S. G. Highway, Gota, Ahmedabad, Gujarat, 382481, India.'}, {'ForeName': 'Vinu', 'Initials': 'V', 'LastName': 'Jose', 'Affiliation': 'Intas Pharmaceuticals Ltd. (Biopharma Division), Plot No: 423/P/A, Sarkhej-Bavla Highway, Moraiya, Sanand, Ahmedabad, Gujarat, 382213, India. vinu_jose@intaspharma.com.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04111-2']
1329,32627192,Caring for others without losing yourself: An adaptation of the Mindful Self-Compassion Program for Healthcare Communities.,"OBJECTIVE


Two studies examined the efficacy of the Self-Compassion for Healthcare Communities (SCHC) program for enhancing wellbeing and reducing burnout among healthcare professionals.
METHOD


Study 1 (N = 58) had a quasi-experimental design and compared wellbeing outcomes for the SCHC group compared to a waitlist control group. Study 2 (N = 23) did not include a control group and examined the effect of SCHC on burnout.
RESULTS


Study 1 found that SCHC significantly increased self-compassion and wellbeing. All gains were maintained for three months. Study 2 found that in addition to enhancing wellbeing, SCHC significantly reduced secondary traumatic stress and burnout. Changes in self-compassion explained gains in other outcomes, and initial levels of self-compassion moderated outcomes so that those initially low in self-compassion benefitted more.
CONCLUSIONS


Findings suggest that the SCHC program may be an effective way to increase self-compassion, enhance wellbeing, and reduce burnout for healthcare professionals.",2020,"Changes in self-compassion explained gains in other outcomes, and initial levels of self-compassion moderated outcomes so that those initially low in self-compassion benefitted more.
",['Study 1 (N\u2009=\u200958'],"['Self-Compassion for Healthcare Communities (SCHC) program', 'SCHC', 'waitlist control group']","['self-compassion and wellbeing', 'self-compassion, enhance wellbeing', 'secondary traumatic stress']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C4042834', 'cui_str': 'Vicarious Traumatization'}]",,0.0128047,"Changes in self-compassion explained gains in other outcomes, and initial levels of self-compassion moderated outcomes so that those initially low in self-compassion benefitted more.
","[{'ForeName': 'Kristin D', 'Initials': 'KD', 'LastName': 'Neff', 'Affiliation': 'Department of Educational Psychology, University of Texas at Austin, Austin, Texas, USA.'}, {'ForeName': 'Marissa C', 'Initials': 'MC', 'LastName': 'Knox', 'Affiliation': 'Department of Educational Psychology, University of Texas at Austin, Austin, Texas, USA.'}, {'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'Long', 'Affiliation': ""Center for Resiliency, Dell Children's Medical Center of Central Texas, Austin, Texas, USA.""}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Gregory', 'Affiliation': ""Center for Resiliency, Dell Children's Medical Center of Central Texas, Austin, Texas, USA.""}]",Journal of clinical psychology,['10.1002/jclp.23007']
1330,32584909,Machine learning insight into the role of imaging and clinical variables for the prediction of obstructive coronary artery disease and revascularization: An exploratory analysis of the CONSERVE study.,"BACKGROUND


Machine learning (ML) is able to extract patterns and develop algorithms to construct data-driven models. We use ML models to gain insight into the relative importance of variables to predict obstructive coronary artery disease (CAD) using the Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization (CONSERVE) study, as well as to compare prediction of obstructive CAD to the CAD consortium clinical score (CAD2). We further perform ML analysis to gain insight into the role of imaging and clinical variables for revascularization.
METHODS


For prediction of obstructive CAD, the entire ICA arm of the study, comprising 719 patients was used. For revascularization, 1,028 patients were randomized to invasive coronary angiography (ICA) or coronary computed tomographic angiography (CCTA). Data was randomly split into 80% training 20% test sets for building and validation. Models used extreme gradient boosting (XGBoost).
RESULTS


Mean age was 60.6 ± 11.5 years and 64.3% were female. For the prediction of obstructive CAD, the AUC was significantly higher for ML at 0.779 (95% CI: 0.672-0.886) than for CAD2 (0.696 [95% CI: 0.594-0.798]) (P = 0.01). BMI, age, and angina severity were the most important variables. For revascularization, the model obtained an overall area under the receiver-operation curve (AUC) of 0.958 (95% CI = 0.933-0.983). Performance did not differ whether the imaging parameters used were from ICA (AUC 0.947, 95% CI = 0.903-0.990) or CCTA (AUC 0.941, 95% CI = 0.895-0.988) (P = 0.90). The ML model obtained sensitivity and specificity of 89.2% and 92.9%, respectively. Number of vessels with ≥70% stenosis, maximum segment stenosis severity (SSS) and body mass index (BMI) were the most important variables. Exclusion of imaging variables resulted in performance deterioration, with an AUC of 0.705 (95% CI 0.614-0.795) (P <0.0001).
CONCLUSIONS


For obstructive CAD, the ML model outperformed CAD2. BMI is an important variable, although currently not included in most scores. In this ML model, imaging variables were most associated with revascularization. Imaging modality did not influence model performance. Removal of imaging variables reduced model performance.",2020,"For the prediction of obstructive CAD, the AUC was significantly higher for ML at 0.779 (95% CI: 0.672-0.886) than for CAD2 (0.696 [95% CI: 0.594-0.798])","['1,028 patients were randomized to', 'Mean age was 60.6 ± 11.5 years and 64.3% were female', 'obstructive coronary artery disease and revascularization', '719 patients was used']","['Machine learning (ML', 'invasive coronary angiography (ICA) or coronary computed tomographic angiography (CCTA', 'Coronary Computed Tomographic Angiography']","['Performance', 'BMI', 'Number of vessels with ≥70% stenosis, maximum segment stenosis severity (SSS) and body mass index (BMI', 'BMI, age, and angina severity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]","[{'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}]",1028.0,0.0893556,"For the prediction of obstructive CAD, the AUC was significantly higher for ML at 0.779 (95% CI: 0.672-0.886) than for CAD2 (0.696 [95% CI: 0.594-0.798])","[{'ForeName': 'Lohendran', 'Initials': 'L', 'LastName': 'Baskaran', 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Xiaohan', 'Initials': 'X', 'LastName': 'Ying', 'Affiliation': 'Dalio Institute of Cardiovascular Imaging, Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Zhuoran', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Subhi J', 'Initials': 'SJ', 'LastName': ""Al'Aref"", 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Benjamin C', 'Initials': 'BC', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Sang-Eun', 'Initials': 'SE', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Integrative Cardiovascular Imaging Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Danad', 'Affiliation': 'VU Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Hyung-Bok', 'Initials': 'HB', 'LastName': 'Park', 'Affiliation': 'Myongji Hospital, Seonam University College of Medicine, Gyeonggi-do, South Korea.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Bathina', 'Affiliation': 'CARE Hospital and FACTS Foundation, Hyderabad, India.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Baggiano', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Beltrama', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Cerci', 'Affiliation': 'Quanta Diagnostico Nuclear, Curitiba, Brazil.'}, {'ForeName': 'Eui-Young', 'Initials': 'EY', 'LastName': 'Choi', 'Affiliation': 'Gangnam Severance Hospital, Seoul, South Korea.'}, {'ForeName': 'Jung-Hyun', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Pusan National University Hospital, Busan, South Korea.'}, {'ForeName': 'So-Yeon', 'Initials': 'SY', 'LastName': 'Choi', 'Affiliation': 'Ajou University Hospital, Gyeonggi-do, South Korea.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Cole', 'Affiliation': 'Cardiology Associates of Mobile, Mobile, Alabama, United States of America.'}, {'ForeName': 'Joon-Hyung', 'Initials': 'JH', 'LastName': 'Doh', 'Affiliation': 'Inje University, Ilsan Paik Hospital, Gyeonggi-do, South Korea.'}, {'ForeName': 'Sang-Jin', 'Initials': 'SJ', 'LastName': 'Ha', 'Affiliation': 'Gangneung Asan Hospital, Gangwon-do, South Korea.'}, {'ForeName': 'Ae-Young', 'Initials': 'AY', 'LastName': 'Her', 'Affiliation': 'Kangwon National University Hospital, Gangwon-do, South Korea.'}, {'ForeName': 'Cezary', 'Initials': 'C', 'LastName': 'Kepka', 'Affiliation': 'Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Jang-Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Wonju Severance Hospital, Gangwon-do, South Korea.'}, {'ForeName': 'Jin-Won', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Korea University Guro Hospital, Seoul, South Korea.'}, {'ForeName': 'Sang-Wook', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Chung-Ang University Hospital, Seoul, South Korea.'}, {'ForeName': 'Woong', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Yeungnam University Hospital, Daegu, South Korea.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Dalio Institute of Cardiovascular Imaging, Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Dalio Institute of Cardiovascular Imaging, Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Heo', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ji Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Dalio Institute of Cardiovascular Imaging, Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Ji-Min', 'Initials': 'JM', 'LastName': 'Sung', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Valeti', 'Affiliation': 'Department of Medicine, Stanford Medicine, Stanford, California, United States of America.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Andreini', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pontone', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Donghee', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': 'Department of Imaging, Cedars-Sinai Medical Center, Cedars-Sinai Heart Institute, Los Angeles, California, United States of America.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Villines', 'Affiliation': 'Department of Medicine, University of Virginia Health System, Charlottesville, Virginia, United States of America.'}, {'ForeName': 'Fay', 'Initials': 'F', 'LastName': 'Lin', 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Hyuk-Jae', 'Initials': 'HJ', 'LastName': 'Chang', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Integrative Cardiovascular Imaging Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Min', 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Leslee J', 'Initials': 'LJ', 'LastName': 'Shaw', 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}]",PloS one,['10.1371/journal.pone.0233791']
1331,32590137,Bone turnover markers in children living with HIV remaining on ritonavir-boosted lopinavir or switching to efavirenz.,"INTRODUCTION


We previously found lower bone mass but similar bone turnover in pre-pubertal children living with HIV (CLWH) on a ritonavir-boosted lopinavir (LPV/r)-based vs. efavirenz-based antiretroviral therapy regimen 2 years after switch. Here, we evaluate if bone turnover differed between the groups close to the time of switch.
METHODS


Samples from 108 children remaining on LPV/r and 104 children switched to efavirenz were available for analysis 8 weeks post-randomization. Bone turnover markers, including C-telopeptide of type 1 collagen (CTx), procollagen type-I N-terminal propeptide (P1NP), and osteocalcin were measured. Markers of immune activation were also measured, including IL-6, TNF-alpha, soluble CD14 and high-sensitivity C-reactive protein (CRP).
RESULTS


Eight weeks post-randomization, we did not detect differences in CTx (1.42 vs. 1.44 ng/mL, p = 0.85) or P1NP concentrations (622 vs. 513 ng/mL, p = 0.68) between treatment groups. At 8 weeks, the treatment groups also had similar levels of IL-6, TNF-alpha, soluble CD14 and high-sensitivity CRP. Osteocalcin (ng/mL) was higher in the LPV/r than efavirenz group both at 8 weeks (88.6 vs. 67.3, p = 0.001) and 2 years (67.6 vs. 49.8, p = 0.001).
CONCLUSIONS


Overall, we failed to detect difference in bone turnover by P1NP and CTx in virologically-suppressed CLWH on different regimens at a time point close to the switch. We did observe higher levels of total osteocalcin in children remaining on LPV/r compared to children switched to efavirenz. Future studies should focus on uncovering the mechanism and determining whether perturbation in undercarboxylated osteocalcin could explain some of the bone side effects noted with protease inhibitors.",2020,"At 8 weeks, the treatment groups also had similar levels of IL-6, TNF-alpha, soluble CD14 and high-sensitivity CRP.","['children living with HIV remaining on ritonavir-boosted lopinavir or switching to', 'Samples from 108 children remaining on LPV/r and 104 children switched to', 'pre-pubertal children living with HIV (CLWH) on a']","['efavirenz', 'ritonavir-boosted lopinavir (LPV/r)-based vs. efavirenz-based antiretroviral therapy']","['IL-6, TNF-alpha, soluble CD14 and high-sensitivity C-reactive protein (CRP', 'Bone turnover markers, including C-telopeptide of type 1 collagen (CTx), procollagen type-I N-terminal propeptide (P1NP), and osteocalcin', 'levels of IL-6, TNF-alpha, soluble CD14 and high-sensitivity CRP', 'Osteocalcin', 'bone turnover by P1NP and CTx', 'total osteocalcin', 'CTx', 'Bone turnover markers', 'bone turnover', 'P1NP concentrations', 'Markers of immune activation']","[{'cui': 'C0553288', 'cui_str': 'Lives with children'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C1628325', 'cui_str': 'Pre-pubertal'}]","[{'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1448177', 'cui_str': 'TNF protein, human'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0041457', 'cui_str': 'Type I Procollagen'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439662', 'cui_str': 'Immune'}]",,0.0664262,"At 8 weeks, the treatment groups also had similar levels of IL-6, TNF-alpha, soluble CD14 and high-sensitivity CRP.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Shiau', 'Affiliation': 'Department of Biostatistics and Epidemiology, Rutgers School of Public Health, Piscataway, NJ, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Yin', 'Affiliation': 'Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Strehlau', 'Affiliation': 'Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Pediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Elaine J', 'Initials': 'EJ', 'LastName': 'Abrams', 'Affiliation': 'Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA; Department of Pediatrics, College of Physicians and Surgeons, Columbia University, New York, NY, USA; ICAP at Columbia, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Coovadia', 'Affiliation': 'Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Pediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Kuhn', 'Affiliation': 'Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York, NY, USA; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Arpadi', 'Affiliation': 'Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York, NY, USA; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA; Department of Pediatrics, College of Physicians and Surgeons, Columbia University, New York, NY, USA; ICAP at Columbia, Mailman School of Public Health, Columbia University, New York, NY, USA. Electronic address: sma2@columbia.edu.'}]",Bone,['10.1016/j.bone.2020.115500']
1332,32591295,Noninferiority of heart failure nurse titration versus heart failure cardiologist titration. ETIFIC multicenter randomized trial.,"INTRODUCTION AND OBJECTIVES


Beta-blockers, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin-II-receptor-blockers (ARB), and mineralocorticoid-receptor antagonists decrease mortality and heart failure (HF) hospitalizations in HF patients with reduced left ventricular ejection fraction. The effect is dose-dependent. Careful titration is recommended. However, suboptimal doses are common in clinical practice. This study aimed to compare the safety and efficacy of dose titration of the aforementioned drugs by HF nurses vs HF cardiologists.
METHODS


ETIFIC was a multicenter (n=20) noninferiority randomized controlled open label trial. A total of 320 hospitalized patients with new-onset HF, reduced ejection fraction and New York Heart Association II-III, without beta-blocker contraindications were randomized 1:1 in blocks of 4 patients each stratified by hospital: 164 to HF nurse titration vs 156 to HF cardiologist titration (144 vs 145 analyzed). The primary endpoint was the beta-blocker mean relative dose (% of target dose) achieved at 4 months. Secondary endpoints included ACE inhibitors, ARB, and mineralocorticoid-receptor antagonists mean relative doses, associated variables, adverse events, and clinical outcomes at 6 months.
RESULTS


The mean±standard deviation relative doses achieved by HF nurses vs HF cardiologists were as follows: beta-blockers 71.09%±31.49% vs 56.29%±31.32%, with a difference of 14.8% (95%CI, 7.5-22.1), P <.001; ACE inhibitors 72.61%±29.80% vs 56.13%±30.37%, P <.001; ARB 44.48%±33.47% vs 43.51%±33.69%, P=.93; and mineralocorticoid-receptor antagonists 71%±32.12% vs 70.47%±29.78%, P=.86; mean±standard deviation visits were 6.41±2.82 vs 2.81±1.58, P <.001, while the number (%) of adverse events were 34 (23.6) vs 30 (20.7), P=.55; and at 6 months HF hospitalizations were 1 (0.69) vs 9 (5.51), P=.01.
CONCLUSIONS


ETIFIC is the first multicenter randomized trial to demonstrate the noninferiority of HF specialist-nurse titration vs HF cardiologist titration. Moreover, HF nurses achieved higher beta-blocker/ACE inhibitors doses, with more outpatient visits and fewer HF hospitalizations. Trial registry number: NCT02546856.",2020,"Moreover, HF nurses achieved higher beta-blocker/ACE inhibitors doses, with more outpatient visits and fewer HF hospitalizations.","['320 hospitalized patients with new-onset HF, reduced ejection fraction and New York Heart Association II-III, without beta-blocker contraindications were randomized 1:1 in blocks of 4 patients each stratified by hospital: 164 to', 'HF patients with reduced left ventricular ejection fraction']","['angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin-II-receptor-blockers (ARB', 'HF nurse titration vs 156 to HF cardiologist titration']","['mortality and heart failure (HF) hospitalizations', 'safety and efficacy', 'adverse events', 'ACE inhibitors, ARB, and mineralocorticoid-receptor antagonists mean relative doses, associated variables, adverse events, and clinical outcomes at 6 months', 'mean±standard deviation visits', 'beta-blocker mean relative dose']","[{'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}]","[{'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0175906', 'cui_str': 'Cardiologist'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",320.0,0.116585,"Moreover, HF nurses achieved higher beta-blocker/ACE inhibitors doses, with more outpatient visits and fewer HF hospitalizations.","[{'ForeName': 'Juana', 'Initials': 'J', 'LastName': 'Oyanguren', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Galdakao-Usansolo, OSI Barrualde-Galdakao-Osakidetza, Servicio Vasco de Salud, Galdakao, Bizkaia, Spain; BIOCRUCES, Instituto de Investigación Sanitaria, Bizkaia, Spain. Electronic address: juanaoy@hotmail.com.'}, {'ForeName': 'Lluisa', 'Initials': 'L', 'LastName': 'Garcia-Garrido', 'Affiliation': ""Unidad de Insuficiencia Cardiaca, Servicio de Cardiología, Hospital Universitario Dr. Josep Trueta, Girona, Spain; Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IDIBGI), Girona, Spain.""}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Nebot-Margalef', 'Affiliation': ""Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain; Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Barcelona, Spain.""}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Latorre-García', 'Affiliation': 'BIOCRUCES, Instituto de Investigación Sanitaria, Bizkaia, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Torcal-Laguna', 'Affiliation': 'BIOCRUCES, Instituto de Investigación Sanitaria, Bizkaia, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Comín-Colet', 'Affiliation': ""Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain; Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Barcelona, Spain.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Roure', 'Affiliation': ""Unidad de Insuficiencia Cardiaca, Servicio de Cardiología, Hospital Universitario Dr. Josep Trueta, Girona, Spain; Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IDIBGI), Girona, Spain.""}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'González-Costello', 'Affiliation': ""Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain; Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Barcelona, Spain.""}, {'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Manito', 'Affiliation': ""Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain; Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Barcelona, Spain.""}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'García-Pinilla', 'Affiliation': 'Unidad de Insuficiencia Cardiaca, Servicio de Cardiología, Hospital Virgen de la Victoria, Málaga, Spain; Instituto de Investigación Sanitaria (IDIMA), Málaga, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Sánchez-Paule', 'Affiliation': 'Unidad de Insuficiencia Cardiaca, Servicio de Cardiología, Hospital Virgen de la Victoria, Málaga, Spain; Instituto de Investigación Sanitaria (IDIMA), Málaga, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Varela-Román', 'Affiliation': 'Unidad de Insuficiencia Cardiaca, Servicio de Cardiología, Hospital Universitario de Santiago, Santiago de Compostela, La Coruña, Spain; Instituto de Investigación Sanitaria de Santiago de Compostela (IDIS), La Coruña, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Moure', 'Affiliation': 'Unidad de Insuficiencia Cardiaca, Servicio de Cardiología, Hospital Universitario de Santiago, Santiago de Compostela, La Coruña, Spain; Instituto de Investigación Sanitaria de Santiago de Compostela (IDIS), La Coruña, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Segovia-Cubero', 'Affiliation': 'Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Puerta de Hierro Majadahonda, Majadahonda, Madrid, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Soria', 'Affiliation': 'Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Puerta de Hierro Majadahonda, Majadahonda, Madrid, Spain.'}, {'ForeName': 'Eunate', 'Initials': 'E', 'LastName': 'Arana-Arri', 'Affiliation': 'BIOCRUCES, Instituto de Investigación Sanitaria, Bizkaia, Spain.'}, {'ForeName': 'Iñaki', 'Initials': 'I', 'LastName': 'Lekuona', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Galdakao-Usansolo, OSI Barrualde-Galdakao-Osakidetza, Servicio Vasco de Salud, Galdakao, Bizkaia, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Revista espanola de cardiologia (English ed.),['10.1016/j.rec.2020.04.016']
1333,32597548,"Randomized trial of an intensified, multifactorial intervention in patients with advanced-stage diabetic kidney disease: Diabetic Nephropathy Remission and Regression Team Trial in Japan (DNETT-Japan).","AIMS/INTRODUCTION


We evaluated the efficacy of multifactorial intensive treatment (IT) on renal outcomes in patients with type 2 diabetes and advanced-stage diabetic kidney disease (DKD).
MATERIALS AND METHODS


The Diabetic Nephropathy Remission and Regression Team Trial in Japan (DNETT-Japan) is a multicenter, open-label, randomized controlled trial with a 5-year follow-up period. We randomly assigned 164 patients with advanced-stage diabetic kidney disease (urinary albumin-to-creatinine ratio ≥300 mg/g creatinine, serum creatinine level 1.2-2.5 mg/dL in men and 1.0-2.5 mg/dL in women) to receive either IT or conventional treatment. The primary composite outcome was end-stage kidney failure, doubling of serum creatinine or death from any cause, which was assessed in the intention-to-treat population.
RESULTS


The IT tended to reduce the risk of primary end-points as compared with conventional treatment, but the difference between treatment groups did not reach the statistically significant level (hazard ratio 0.69, 95% confidence interval 0.43-1.11; P = 0.13). Meanwhile, the decrease in serum low-density lipoprotein cholesterol level and the use of statin were significantly associated with the decrease in primary outcome (hazard ratio 1.14; 95% confidence interval 1.05-1.23, P < 0.001 and hazard ratio 0.53, 95% confidence interval 0.28-0.998, P < 0.05, respectively). The incidence of adverse events was not different between treatment groups.
CONCLUSIONS


The risk of kidney events tended to decrease by IT, although it was not statistically significant. Lipid control using statin was associated with a lower risk of adverse kidney events. Further follow-up study might show the effect of IT in patients with advanced diabetic kidney disease.",2020,"The IT tended to reduce the risk of primary endpoints as compared to CT, but the difference between treatment groups did not reach the statistically significant level (hazard ratio (HR), 0.69; 95% confidence interval [CI], 0.43 to 1.11; P=0.13).","['Diabetic Nephropathy Remission and Regression Team Trial in Japan (DNETT-Japan', '164 patients with advanced stage of DKD (urinary albumin-to-creatinine ratio ≥300', 'patients with advanced DKD', 'Patients with Advanced Stage of Diabetic Kidney Disease', 'patients with type 2 diabetes and advanced stage of diabetic kidney disease (DKD']","['Intensified, Multifactorial Intervention', 'IT or conventional treatment (CT', 'multifactorial intensive treatment (IT']","['renal outcomes', 'risk of kidney events', 'adverse events', 'serum LDL cholesterol level', 'stage kidney failure, doubling of serum creatinine, or death from any cause, which was assessed in the intention-to treat population']","[{'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0428474', 'cui_str': 'Serum LDL cholesterol measurement'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",164.0,0.147588,"The IT tended to reduce the risk of primary endpoints as compared to CT, but the difference between treatment groups did not reach the statistically significant level (hazard ratio (HR), 0.69; 95% confidence interval [CI], 0.43 to 1.11; P=0.13).","[{'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Shikata', 'Affiliation': 'Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Haneda', 'Affiliation': 'Division of Metabolism and Biosystemic Science, Department of Medicine, Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Toshiharu', 'Initials': 'T', 'LastName': 'Ninomiya', 'Affiliation': 'Department of Epidemiology and Public Health, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Koya', 'Affiliation': 'Department of Diabetology & Endocrinology, Kanazawa Medical University, Ishikawa, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Health Administration Center, Niigata University, Niigata, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Suzuki', 'Affiliation': 'Suzuki Diabetes Clinic, Kanagawa, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Ishida', 'Affiliation': 'Research Center for Health Care, Nagahama City Hospital, Shiga, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Akai', 'Affiliation': 'Division of Metabolism and Diabetes, Tohoku Medical and Pharmaceutical University, Sendai, Japan.'}, {'ForeName': 'Yasuhiko', 'Initials': 'Y', 'LastName': 'Tomino', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Juntendo University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Uzu', 'Affiliation': 'Division of Nephrology, Department of Medicine, Nippon Life Hospital, Osaka, Japan.'}, {'ForeName': 'Motonobu', 'Initials': 'M', 'LastName': 'Nishimura', 'Affiliation': 'Department of Diabetes and Endocrinology, National Hospital Organization Chiba-East National Hospital, Chiba, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Maeda', 'Affiliation': 'Department of Advanced Genomic and Laboratory Medicine, Graduate School of Medicine, University of the Ryukyus, Okinawa, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Ogawa', 'Affiliation': 'Okayama Diabetes and Neurology Clinic, Okayama, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Miyamoto', 'Affiliation': 'Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Makino', 'Affiliation': 'Okayama University, Okayama, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of diabetes investigation,['10.1111/jdi.13339']
1334,32594328,Correction to: Footprint preparation with nanofractures in a supraspinatus repair cuts in half the retear rate at 1-year follow-up. A randomized controlled trial.,The article Footprint preparation with nanofractures in a supraspinatus repair cuts in half the retear rate at 1-year follow-up.,2020,The article Footprint preparation with nanofractures in a supraspinatus repair cuts in half the retear rate at 1-year follow-up.,[],[],[],[],[],[],,0.062914,The article Footprint preparation with nanofractures in a supraspinatus repair cuts in half the retear rate at 1-year follow-up.,"[{'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Ruiz Ibán', 'Affiliation': 'Unidad de Hombro y Codo, Hospital Universitario Ramón y Cajal, Cta Colmenar km 9,100, 28046, Madrid, Spain. drmri@hotmail.com.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Sanchez Alepuz', 'Affiliation': 'Hospital IMED Valencia, Valencia, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Diaz Heredia', 'Affiliation': 'Unidad de Hombro y Codo, Hospital Universitario Ramón y Cajal, Cta Colmenar km 9,100, 28046, Madrid, Spain.'}, {'ForeName': 'Abdul-Ilah', 'Initials': 'AI', 'LastName': 'Hachem', 'Affiliation': 'Head of the Shoulder Unit, Hospital Universitario de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Ezagüi Bentolila', 'Affiliation': 'Hospital Egarsat, Barcelona, Spain.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Calvo', 'Affiliation': 'Arthrosport, Zaragoza, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Verdú', 'Affiliation': 'Unidad de Hombro y Codo, Hospital General Universitario de Elche, Elche, Alicante, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'de Rus Aznar', 'Affiliation': 'Unidad de Hombro y Codo, Hospital Universitario Ramón y Cajal, Cta Colmenar km 9,100, 28046, Madrid, Spain.'}, {'ForeName': 'Francesc', 'Initials': 'F', 'LastName': 'Soler Romagosa', 'Affiliation': 'Traumadvance, Terrassa, Barcelona, Spain.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-06118-x']
1335,32598217,Laparoscopic Repair of Pediatric Inguinal Hernia: Disconnection of the Hernial Sac Versus Disconnection and Peritoneal Closure.,"Background/Purpose:  Many techniques have been described for the treatment of pediatric inguinal hernia (PIH). Some authors emphasized the importance of disconnecting the sac, to create a scar, and to close the peritoneum mimicking the open approach. Others stated that peritoneal disconnection alone is enough for treatment of PIH regardless of the size of the internal ring. In this study, we compare the short-term results of laparoscopic disconnection of PIH sac versus disconnection and peritoneal closure.  Patients and Methods:  The study was carried from March 2016 to March 2017, on 34 patients with 40 PIH. Patients were randomly divided into two groups: group A, subjected to laparoscopic hernia sac disconnection and group B, subjected to laparoscopic hernia sac disconnection with peritoneal closure. Both groups were compared regarding the operative details, including complications and conversion, postoperative complications and recurrence.  Results:  Group A included 20 hernias in 15 patients, whereas group B included 20 hernias in 19 patients. The age ranged from 1 to 23 months. In group A, the mean operative time (OT) was 34.6 and 39.4 minutes, for unilateral and bilateral cases, respectively, whereas in group B, it was 45.1 minutes for unilateral cases and 65 minutes for 1 bilateral case. The OT was significantly shorter in group A for unilateral cases. There was no conversion and no intraoperative complications. Three recurrences occurred in group A (15% of hernias/20% of cases) with no recurrences in group B; difference was statistically insignificant. All 3 recurrences occurred in hernias with an internal ring diameter (IRD) >10 mm. Hospital stay was statistically shorter in group B.  Conclusion:  Both laparoscopic sac disconnection with internal ring closure and sac disconnection only are safe and effective treatments of PIH. However, the latter technique is not recommended for cases with IRD >10 mm because of the unacceptable high recurrence with rings >10 mm.",2020,All 3 recurrences occurred in hernias with an internal ring diameter (IRD),"['March 2016 to March 2017, on 34 patients with 40 PIH', 'Group A included 20 hernias in 15 patients, whereas group B included 20 hernias in 19 patients', 'pediatric inguinal hernia (PIH']","['laparoscopic disconnection of PIH sac versus disconnection and peritoneal closure', 'internal ring diameter (IRD', 'laparoscopic hernia sac disconnection and group B, subjected to laparoscopic hernia sac disconnection with peritoneal closure', 'Laparoscopic Repair of Pediatric Inguinal Hernia: Disconnection of the Hernial Sac Versus Disconnection and Peritoneal Closure', 'laparoscopic sac disconnection with internal ring closure and sac disconnection']","['OT', 'mean operative time (OT', 'no conversion and no intraoperative complications', 'Hospital stay', 'operative details, including complications and conversion, postoperative complications and recurrence']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033373', 'cui_str': 'Prolactin inhibiting factor'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0033373', 'cui_str': 'Prolactin inhibiting factor'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0333062', 'cui_str': 'Hernia sac'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",34.0,0.0206724,All 3 recurrences occurred in hernias with an internal ring diameter (IRD),"[{'ForeName': 'Akram Mohamed', 'Initials': 'AM', 'LastName': 'Elbatarny', 'Affiliation': 'Department of Pediatric Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohammad G', 'Initials': 'MG', 'LastName': 'Khairallah', 'Affiliation': 'Department of Pediatric Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mostafa M', 'Initials': 'MM', 'LastName': 'Elsayed', 'Affiliation': 'Department of Pediatric Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Amel A', 'Initials': 'AA', 'LastName': 'Hashish', 'Affiliation': 'Department of Pediatric Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]",Journal of laparoendoscopic & advanced surgical techniques. Part A,['10.1089/lap.2018.0679']
1336,32608554,Effects of mirror neuron system-based training on rehabilitation of stroke patients.,"OBJECTIVE


To investigate the clinical effects of the mirror neuron system (MNS)-based training on upper extremity motor function and cognitive function in stroke patients.
METHODS


Sixty stroke patients (time from stroke onset 3-9 months) with upper extremity paresis (Brunnstrom stage II-IV) and cognitive impairment (MoCA score ≥ 15) were enrolled in this study. Patients were randomly allocated into MNS treatment group (N = 30) and control group (N = 30). Both groups underwent regular training for upper extremity motor function and cognitive function, and the MNS group was trained with a therapeutic apparatus named mirror neuron system training (MNST) including different levels of action observation training (AOT). Training lasted 20 min/day, 5 days/week for 8 weeks. MoCA, reaction time, and Wisconsin Card Sorting Test (WCST) were assessed at baseline and 8 weeks after training. Furthermore, Fugl-Meyer assessment (FMA) and Modified Barthel index (MBI) were adopted to evaluated upper extremity motor function and daily life ability.
RESULTS


After 8 consecutive weeks' training, both groups showed significant improvements on the upper extremity motor function, cognitive function, and daily life ability score after training (p < .05). The MNS group showed significantly improved upper extremity motor function and cognitive function (p < .05) compared with control group.
CONCLUSIONS


Combining MNS-based and conventional training can improve upper extremity motor function and cognitive function in stroke patients.",2020,"The MNS group showed significantly improved upper extremity motor function and cognitive function (p < .05) compared with control group.
","['stroke patients', 'Sixty stroke patients (time from stroke onset 3-9\xa0months) with upper extremity paresis (Brunnstrom stage II-IV) and cognitive impairment']","['mirror neuron system-based training', 'regular training', 'MNS group was trained with a therapeutic apparatus named mirror neuron system training (MNST) including different levels of action observation training (AOT', 'Combining MNS-based and conventional training', 'MNS', 'mirror neuron system (MNS)-based training']","['Furthermore, Fugl-Meyer assessment (FMA) and Modified Barthel index (MBI', 'upper extremity motor function and cognitive function', 'upper extremity motor function, cognitive function, and daily life ability score', 'MoCA, reaction time, and Wisconsin Card Sorting Test (WCST']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0751409', 'cui_str': 'Monoparesis - arm'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C3178760', 'cui_str': 'Mirror Neurons'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0243111', 'cui_str': 'apparatus'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0451592', 'cui_str': 'Wisconsin card sorting test'}]",60.0,0.0126903,"The MNS group showed significantly improved upper extremity motor function and cognitive function (p < .05) compared with control group.
","[{'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Mao', 'Affiliation': 'Department of Rehabilitation Medicine, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation Medicine, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Department of Rehabilitation Medicine, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jiawei', 'Initials': 'J', 'LastName': 'Ni', 'Affiliation': 'Department of Rehabilitation Medicine, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Chunlei', 'Initials': 'C', 'LastName': 'Shan', 'Affiliation': 'School of Rehabilitation Science and Institute of Rehabilitation Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}]",Brain and behavior,['10.1002/brb3.1729']
1337,32603956,Leptin mediates improvements in cognitive function following treatment with infliximab in adults with bipolar depression.,"A potential role for leptin in the pathophysiology of bipolar disorder (BD) has been proposed. We recently investigated the effects of the tumor necrosis factor-alpha (TNF-α) antagonist infliximab in individuals with bipolar depression. Leptin is known to interact with the TNF-α system. Herein, we aimed to explore infliximab's effects on leptin and its relationship with brain structure and function. Sixty adults with bipolar depression were enrolled in this randomized, double-blind, 12-week clinical trial of adjunctive infliximab (n = 29) and saline control (n = 31), which were administered intravenously at weeks 0, 2, and 6. Plasma concentrations of leptin, TNF-α and soluble TNF receptors (sTNFR) 1 and 2 were assessed at weeks 0, 2, 6, and 12. We observed a significant decrease in leptin levels in infliximab-treated patients, relative to placebo. Infliximab treatment also significantly reduced TNF-α and sTNFR2, but not sTNFR1 levels. Changes in sTNR2 levels at week 6 significantly determined changes in leptin at week 12 in infliximab-, but not placebo-treated participants. Improvements in verbal memory and increases in global cortical volume were associated with reduction in leptin levels in the treatment group. Mediation analysis indicated that cognitive improvement in infliximab-treated patients was mediated by reductions in leptin levels, which in its turn were determined by decreases in sTNR2 levels. In conclusion, infliximab treatment reduced plasma leptin levels in individuals with BD, through modulation of sTNFR2. Decreases in leptin signaling were associated with an increase in global cortical volume and better performance in a verbal memory task.",2020,"Infliximab treatment also significantly reduced TNF-α and sTNFR2, but not sTNFR1 levels.","['Sixty adults with bipolar depression', 'individuals with BD', 'adults with bipolar depression', 'individuals with bipolar depression']","['Leptin', 'saline control', 'adjunctive infliximab', 'infliximab', 'Infliximab', 'tumor necrosis factor-alpha (TNF-α) antagonist infliximab', 'placebo']","['leptin', 'cognitive improvement', 'global cortical volume and better performance in a verbal memory task', 'cognitive function', 'Plasma concentrations of leptin, TNF-α and soluble TNF receptors (sTNFR', 'verbal memory', 'plasma leptin levels', 'global cortical volume', 'leptin signaling', 'leptin levels', 'TNF-α and sTNFR2', 'sTNR2 levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}]","[{'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0077503', 'cui_str': 'Tumor Necrosis Factor Receptor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",60.0,0.149116,"Infliximab treatment also significantly reduced TNF-α and sTNFR2, but not sTNFR1 levels.","[{'ForeName': 'Rodrigo B', 'Initials': 'RB', 'LastName': 'Mansur', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada. Electronic address: rodrigo.mansur@uhn.ca.'}, {'ForeName': 'Mehala', 'Initials': 'M', 'LastName': 'Subramaniapillai', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Yena', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Zihang', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Carmona', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychology, Ryerson University, Toronto, ON, Canada.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Shekotikhina', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; University of Ottawa, Department of Psychiatry, Ottawa, ON, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Iacobucci', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Rodrigues', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Nasri', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Houman', 'Initials': 'H', 'LastName': 'Rashidian', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Rosenblat', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Brietzke', 'Affiliation': ""Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Kingston General Hospital, Providence Care Hospital, Department of Psychiatry, Queen's University School of Medicine, Kingston, ON, Canada.""}, {'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Cosgrove', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Kramer', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Suppes', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'McIntyre', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104779']
1338,32603994,A randomized-controlled examination of the effect of cognitive reappraisal instruction on maternal accommodation of child anxiety symptoms.,"Parental accommodation plays a key role in the maintenance of child anxiety, yet much of the research to date has been correlational, making it difficult to draw conclusions about underlying mechanisms. Given preliminary evidence that parental beliefs play a role in parental accommodation, the present study sought to experimentally reduce accommodation by targeting parental attitudes about child anxiety. Mothers of children ages 4-9 (N = 47) were randomly assigned to either receive brief instruction in cognitive reappraisal (EXP) or to a control intervention in which they received no instruction (CON). At pre- and post-intervention mothers were presented with bogus information that their child was experiencing varying levels of distress while completing a task in a nearby room. Maternal distress, negative affect and perceived likelihood of accommodation in the context of child distress were measured pre- and post-intervention. EXP mothers reported greater pre- to post-intervention decreases in distress and perceived likelihood of accommodation, compared to CON mothers. EXP and CON mothers showed similar changes in negative affect. Findings from this study provide preliminary experimental evidence that targeting maternal beliefs about child anxiety can result in changes in maternal distress and behavior following exposure to child distress. Implications for prevention and treatment are discussed.",2020,"EXP mothers reported greater pre- to post-intervention decreases in distress and perceived likelihood of accommodation, compared to CON mothers.",['Mothers of children ages 4-9 (N = 47'],"['cognitive reappraisal instruction', 'brief instruction in cognitive reappraisal (EXP) or to a control intervention in which they received no instruction (CON']","['distress and perceived likelihood of accommodation', 'Maternal distress, negative affect and perceived likelihood of accommodation in the context of child distress', 'maternal accommodation of child anxiety symptoms']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0473485', 'cui_str': 'Maternal distress'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",47.0,0.050831,"EXP mothers reported greater pre- to post-intervention decreases in distress and perceived likelihood of accommodation, compared to CON mothers.","[{'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. #2, Boston, MA, 02215, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Langer', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. #2, Boston, MA, 02215, United States.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Comer', 'Affiliation': 'Department of Psychology, Florida International University, 11200 SW 8th Street, Miami, FL, 33199, United States.'}, {'ForeName': 'Martha C', 'Initials': 'MC', 'LastName': 'Tompson', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. #2, Boston, MA, 02215, United States.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102260']
1339,32605298,Efficacy of Panitumumab and Cetuximab in Patients with Colorectal Cancer Previously Treated with Bevacizumab; a Combined Analysis of Individual Patient Data from ASPECCT and WJOG6510G.,"BACKGROUND


Phase-III ASPECCT and randomised phase-II WJOG6510G trials demonstrated the noninferiority of panitumumab, when compared with cetuximab, for overall survival in patients with chemotherapy-refractory wild-type  KRAS  exon 2 metastatic colorectal cancer.
METHODS


The subgroup that received bevacizumab either prior to panitumumab or cetuximab monotherapy (ASPECCT) or in combination with irinotecan (WJOG6510G) was included. Multivariate Cox models were created, including the treatment arms as covariates together with patient, disease and treatment characteristics.
RESULTS


We included 185 and 189 patients in the panitumumab and cetuximab arms, respectively. The median overall survival was 12.8 and 10.1 months [ p  = 0.0031; log-rank test, stratified by trial; hazard ratio (HR), 0.72; 95% confidence interval (CI), 0.58-0.90], and the median progression-free survival was 4.7 and 4.1 months, in the panitumumab and cetuximab arms, respectively ( p  = 0.0207; HR, 0.79; 95% CI, 0.64-0.97). The treatment regimen was an independent prognostic factor of overall survival (adjusted HR, 0.69; 95% CI, 0.54-0.87;  p  = 0.0013).
CONCLUSIONS


Panitumumab significantly prolonged the overall survival and progression-free survival, when compared with cetuximab in the cohort that previously received bevacizumab in the included studies. Clinical Trial Registration :  ASPECCT trial registered with ClinicalTrials.gov (NCT01001377) and WJOG6510G trial registered with UMIN-CTR (UMIN000006643).",2020,"G trials demonstrated the noninferiority of panitumumab, when compared with cetuximab, for overall survival in patients with chemotherapy-refractory wild-type  KRAS  exon 2 metastatic colorectal cancer.
","['patients with chemotherapy-refractory wild-type  KRAS  exon 2 metastatic colorectal cancer', '185 and 189 patients in the panitumumab and cetuximab arms, respectively', 'Patients with Colorectal Cancer']","['Bevacizumab', 'WJOG6510', 'cetuximab', 'ASPECCT and WJOG6510G', 'bevacizumab either prior to panitumumab or cetuximab monotherapy (ASPECCT) or in combination with irinotecan (WJOG6510G', 'panitumumab', 'Panitumumab and Cetuximab', 'bevacizumab']","['median progression-free survival', 'overall survival', 'median overall survival', 'prognostic factor of overall survival', 'overall survival and progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}]",,0.446552,"G trials demonstrated the noninferiority of panitumumab, when compared with cetuximab, for overall survival in patients with chemotherapy-refractory wild-type  KRAS  exon 2 metastatic colorectal cancer.
","[{'ForeName': 'Hiroya', 'Initials': 'H', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Centre Hospital East, Kashiwa 277-8577, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University School of Medicine, Yokohama 236-0004, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sakai', 'Affiliation': 'Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita 565-0871, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Centre, Nagoya 464-8681, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Centre, Shizuoka 411-8777, Japan.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Nakata', 'Affiliation': 'Department of Clinical Oncology, Kyoto Pharmaceutical University, Kyoto 607-8414, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kimura', 'Affiliation': 'Department of Analytical and Bioinorganic Chemistry, Kyoto Pharmaceutical University, Kyoto 607-8414, Japan.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ruff', 'Affiliation': 'University of Witwatersrand MRC Common Epithelial Cancers Research Centre, Johannesburg 2193, South Africa.'}, {'ForeName': 'Tae Won', 'Initials': 'TW', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Centre, University of Ulsan College of Medicine, Seoul 05505, Korea.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': 'Department of Oncology, U.Z.A. University Hospital Antwerp, 2650 Edegem, Belgium.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Price', 'Affiliation': 'Department of Medical Oncology, Queen Elizabeth Hospital and University of Adelaide, 5011 Woodville, Australia.'}]",Cancers,['10.3390/cancers12071715']
1340,32610581,"Pimasertib Versus Dacarbazine in Patients With Unresectable  NRAS -Mutated Cutaneous Melanoma: Phase II, Randomized, Controlled Trial with Crossover.","This study investigated the efficacy and safety of pimasertib ( MEK 1/ MEK 2 inhibitor) versus dacarbazine (DTIC) in patients with untreated  NRAS -mutated melanoma. Phase II, multicenter, open-label trial. Patients with unresectable, stage IIIc/IVM1  NRAS -mutated cutaneous melanoma were randomized 2:1 to pimasertib (60 mg; oral twice-daily) or DTIC (1000 mg/m 2 ; intravenously) on Day 1 of each 21-day cycle. Patients progressing on DTIC could crossover to pimasertib. Primary endpoint: investigator-assessed progression-free survival (PFS); secondary endpoints: overall survival (OS), objective response rate (ORR), quality of life (QoL), and safety. Overall, 194 patients were randomized (pimasertib  n  = 130, DTIC  n  = 64), and 191 received treatment (pimasertib  n  = 130, DTIC  n  = 61). PFS was significantly improved with pimasertib versus DTIC (median 13 versus 7 weeks, respectively; hazard ratio (HR) 0.59, 95% confidence interval (CI) 0.42-0.83;  p  = 0.0022). ORR was improved with pimasertib (odds ratio 2.24, 95% CI 1.00-4.98;  p  = 0.0453). OS was similar between treatments (median 9 versus 11 months, respectively; HR 0.89, 95% CI 0.61-1.30); 64% of patients receiving DTIC crossed over to pimasertib. Serious adverse events (AEs) were more frequent for pimasertib (57%) than DTIC (20%). The most common treatment-emergent AEs were diarrhea (82%) and blood creatine phosphokinase (CPK) increase (68%) for pimasertib, and nausea (41%) and fatigue (38%) for DTIC. Most frequent grade ≥3 AEs were CPK increase (34%) for pimasertib and neutropenia (15%) for DTIC. Mean QoL scores (baseline and last assessment) were similar between treatments. Pimasertib has activity in  NRAS -mutated cutaneous melanoma and a safety profile consistent with known toxicities of  MEK  inhibitors. Trial registration: ClinicalTrials.gov, NCT01693068.",2020,"ORR was improved with pimasertib (odds ratio 2.24, 95% CI 1.00-4.98;  p  = 0.0453).","['patients with untreated  NRAS -mutated melanoma', '194 patients were randomized (pimasertib  n  = 130, DTIC  n  = 64), and 191 received treatment (pimasertib  n  = 130, DTIC  n  = 61', 'Patients With Unresectable  NRAS -Mutated Cutaneous Melanoma', 'Patients with unresectable, stage IIIc/IVM1', 'NRAS -mutated cutaneous melanoma']","['DTIC', 'Pimasertib Versus Dacarbazine', 'dacarbazine (DTIC']","['diarrhea', 'progression-free survival (PFS); secondary endpoints: overall survival (OS), objective response rate (ORR), quality of life (QoL), and safety', 'PFS', 'OS', 'fatigue', 'Serious adverse events (AEs', 'ORR', 'CPK increase', 'efficacy and safety', 'blood creatine phosphokinase (CPK) increase', 'pimasertib and neutropenia', 'Mean QoL scores', 'nausea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0456608', 'cui_str': 'Stage 3C'}]","[{'cui': 'C0010927', 'cui_str': 'Dacarbazine'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0151576', 'cui_str': 'Creatine phosphokinase increased'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0853034', 'cui_str': 'Blood creatine phosphokinase increased'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",194.0,0.626062,"ORR was improved with pimasertib (odds ratio 2.24, 95% CI 1.00-4.98;  p  = 0.0453).","[{'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Lebbé', 'Affiliation': 'AP-HP Dermatology CIC Department, Saint Louis Hospital, and INSERM U976, Université de Paris, 75010 Paris, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dutriaux', 'Affiliation': 'Dermatology, Hopital Saint-Andre-CHU, 33000 Bordeaux, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lesimple', 'Affiliation': 'Medical Oncology Department, Comprehensive Cancer Center Eugène Marquis, 35000 Rennes, France.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Kruit', 'Affiliation': 'Internal Oncology, Erasmus MC Cancer Institute, 3008 AE Rotterdam, The Netherlands.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Kerger', 'Affiliation': 'Medical Oncology, Institut Jules Bordet, 1000 Brussels, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Thomas', 'Affiliation': 'Department of Dermatology, Centre Hospitalier Lyon Sud, 69310 Pierre Bénite, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Guillot', 'Affiliation': 'Department of Dermatology, Hôpital Saint Eloi, 34295 Montpellier, France.'}, {'ForeName': 'Filippo de', 'Initials': 'F', 'LastName': 'Braud', 'Affiliation': 'Department of Medical Oncology, Istituto Nazionale dei Tumori, Università degli Studi di Milano, 20133 Milano, Italy.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Garbe', 'Affiliation': 'Department of Dermatology, University Hospital Tübingen, 72076 Tübingen, Germany.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Department of Dermatology and Cutaneous Oncology Service, Hôpital de la Timone, 13005 Marseille, France.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Loquai', 'Affiliation': 'Department of Dermatology, University Medical Center Mainz, 55019 Mainz, Germany.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Ferraresi', 'Affiliation': 'Division of Medical Oncology 1, IRCCS ""Regina Elena"" National Cancer Institute, 00144 Roma, Italy.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Dermatology Department, Institut Gustave Roussy and Paris Sud University, 94800 Villejuif, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Vasey', 'Affiliation': 'Icon Cancer Care, The Wesley Hospital, Auchenflower, QLD 4066, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Conry', 'Affiliation': 'Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL 35233, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Isaacs', 'Affiliation': 'MidCentral Regional Cancer Treatment Service, Palmerston North Hospital, Palmerston North 4442, New Zealand.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Espinosa', 'Affiliation': 'Medical Oncology Department, Hospital Universitario La Paz, 28046 Madrid, Spain.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Schueler', 'Affiliation': 'Global Biostatistics Oncology, Merck KGaA, 64293 Darmstadt, Germany.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Massimini', 'Affiliation': 'GCDU Oncology, Merck KGaA, 64293 Darmstadt, Germany.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Dréno', 'Affiliation': 'Department of Dermato Cancerology, CIC 1413, CRCINA Inserm 1232, CHU Nantes, 44093 Nantes, France.'}]",Cancers,['10.3390/cancers12071727']
1341,32630241,Percutaneous Electrolysis in the Treatment of Lateral Epicondylalgia: A Single-Blind Randomized Controlled Trial.,"Few studies have considered the effects of percutaneous electrolysis (PE) in the treatment of lateral epicondylalgia (LE). For this reason, the objective of this study was to compare the effects of PE with an evidence-based approach-trigger point dry needling (TDN)-in patients with LE. A randomized controlled trial was conducted in which 32 participants with LE were randomly assigned to two treatment groups, the PE group ( n  = 16) and the TDN group ( n  = 16). Both groups received four therapy sessions and an eccentric exercise program to be performed daily. The numerical pain rating scale (NPRS), pressure pain thresholds (PPT), quality of life, and range of motion were measured before treatment, at the end of treatment, and at one- and three-month follow-ups. Significant between-group mean differences were found after treatment for NPRS ( p  < 0.001) and flexion movement ( p  = 0.006). At one-month follow-up, significant mean differences between groups were found for NPRS ( p  < 0.001), PPT ( p  = 0.021), and flexion ( p  = 0.036). At three-months follow-up, significant mean differences between groups were found for NPRS ( p  < 0.001), PPT ( p  = 0.004), and flexion ( p  = 0.003). This study provides evidence that PE could be more effective than TDN for short- and medium-term improvement of pain and PPTs in LE when added to an eccentric exercise program.",2020,Significant between-group mean differences were found after treatment for NPRS ( p  < 0.001) and flexion movement ( p  = 0.006).,"['patients with LE', '32 participants with LE', 'Lateral Epicondylalgia']","['PE with an evidence-based approach-trigger point dry needling (TDN)-in', 'TDN', 'percutaneous electrolysis (PE', 'Percutaneous Electrolysis', 'PE', 'eccentric exercise program']","['numerical pain rating scale (NPRS), pressure pain thresholds (PPT), quality of life, and range of motion', 'NPRS', 'flexion movement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0013829', 'cui_str': 'Electrolysis - action'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",32.0,0.110392,Significant between-group mean differences were found after treatment for NPRS ( p  < 0.001) and flexion movement ( p  = 0.006).,"[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Rodríguez-Huguet', 'Affiliation': 'Department of Nursery and Physiotherapy, University of Cádiz, 11009 Cádiz, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Góngora-Rodríguez', 'Affiliation': 'Policlínica Santa María Clinic, 11008 Cádiz, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Lomas-Vega', 'Affiliation': 'Department of Health Sciences, University of Jaén, Campus las Lagunillas, 23071 Jaén, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Martín-Valero', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, University of Málaga, 29071 Málaga, Spain.'}, {'ForeName': 'Ángeles', 'Initials': 'Á', 'LastName': 'Díaz-Fernández', 'Affiliation': 'Department of Health Sciences, University of Jaén, Campus las Lagunillas, 23071 Jaén, Spain.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Obrero-Gaitán', 'Affiliation': 'Department of Health Sciences, University of Jaén, Campus las Lagunillas, 23071 Jaén, Spain.'}, {'ForeName': 'Alfonso Javier', 'Initials': 'AJ', 'LastName': 'Ibáñez-Vera', 'Affiliation': 'Department of Health Sciences, University of Jaén, Campus las Lagunillas, 23071 Jaén, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rodríguez-Almagro', 'Affiliation': 'Department of Health Sciences, University of Jaén, Campus las Lagunillas, 23071 Jaén, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9072068']
1342,32600481,Interleukin-6 and total antioxidant capacity levels following  N -acetylcysteine and a combination nutraceutical intervention in a randomised controlled trial for bipolar disorder.,"OBJECTIVE


The aims of this study were to evaluate changes in inflammatory and oxidative stress levels following treatment with N-acetylcysteine (NAC) or mitochondrial-enhancing agents (CT), and to assess the how these changes may predict and/or moderate clinical outcomes primarily the Montgomery-Åsberg Depression Rating Scale (MADRS).
METHODS


This study involved secondary analysis of a placebo-controlled randomised trial (n = 163). Serum samples were collected at baseline and week 16 of the clinical trial to determine changes in Interleukin-6 (IL-6) and total antioxidant capacity (TAC) following adjunctive CT and/or NAC treatment, and to explore the predictability of the outcome or moderator effects of these markers.
RESULTS


In the NAC-treated group, no difference was observed in serum IL-6 and TAC levels after 16 weeks of treatment with NAC or CT. However, results from a moderator analysis showed that in the CT group, lower IL-6 levels at baseline was a significant moderator of MADRS χ2 (df) = 4.90, p = 0.027) and Clinical Global Impression-Improvement (CGI-I, χ2 (df) = 6.28 p = 0.012). In addition, IL-6 was a non-specific but significant predictor of functioning (based on the Social and Occupational Functioning Assessment Scale (SOFAS)), indicating that individuals with higher IL-6 levels at baseline had a greater improvement on SOFAS regardless of their treatment (p = 0.023).
CONCLUSION


Participants with lower IL-6 levels at baseline had a better response to the adjunctive treatment with the mitochondrial-enhancing agents in terms of improvements in MADRS and CGI-I outcomes.",2020,"In the NAC treated group, no difference was observed in serum IL-6 and TAC levels after 16 weeks of treatment with NAC or CT.",['bipolar disorder'],"['N-acetylcysteine and a combination nutraceutical intervention', 'N-acetylcysteine (NAC) or mitochondrial-enhancing agents (CT', 'placebo']","['Clinical Global Impression-improvement (CGI-I, X2', 'SOFAS regardless', 'IL-6 levels', 'serum IL-6 and TAC levels', 'lower IL-6 levels', 'interleukin (IL)-6 and total antioxidant capacity (TAC', 'Interleukin-6 and total antioxidant capacity levels', 'inflammatory and oxidative stress levels', 'Montgomery-Åsberg Depression Rating Scale (MADRS', 'Social and Occupational Functioning Assessment Scale (SOFAS']","[{'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C1518478', 'cui_str': 'Nutriceuticals'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}]",163.0,0.296478,"In the NAC treated group, no difference was observed in serum IL-6 and TAC levels after 16 weeks of treatment with NAC or CT.","[{'ForeName': 'C C', 'Initials': 'CC', 'LastName': 'Bortolasci', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation, Deakin University, Barwon Health, Geelong, Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Voigt', 'Affiliation': 'University of Bremen, Bremen, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation, Deakin University, Barwon Health, Geelong, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mohebbi', 'Affiliation': 'Biostatistics Unit, Faculty of Health, Deakin University, Geelong, Australia.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gray', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation, Deakin University, Barwon Health, Geelong, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dodd', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation, Deakin University, Barwon Health, Geelong, Australia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Walder', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation, Deakin University, Barwon Health, Geelong, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation, Deakin University, Barwon Health, Geelong, Australia.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Cotton', 'Affiliation': 'Orygen, Parkville, Australia.'}, {'ForeName': 'G S', 'Initials': 'GS', 'LastName': 'Malhi', 'Affiliation': 'Northern Clinical School, Department of Psychiatry, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Ng', 'Affiliation': 'Professorial Unit, The Melbourne Clinic, Department of Psychiatry, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Dowling', 'Affiliation': 'Professorial Unit, The Melbourne Clinic, Department of Psychiatry, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sarris', 'Affiliation': 'Professorial Unit, The Melbourne Clinic, Department of Psychiatry, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'O M', 'Initials': 'OM', 'LastName': 'Dean', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation, Deakin University, Barwon Health, Geelong, Australia.'}]",Acta neuropsychiatrica,['10.1017/neu.2020.25']
1343,32598387,Bleeding profile of women using a drospirenone-only pill 4 mg over nine cycles in comparison with desogestrel 0.075 mg.,"BACKGROUND


Progestin-only pills are associated with irregular bleeding pattern including amenorrhea. Desogestrel 75mcg even being a pill that inhibits ovulation shows a poor cycle control that limits a more common use. A drospirenone (DRSP)-only pill was developed to improve the bleeding profile.
METHODS


A phase III study in healthy women aged 18 to 45 years was performed to compare the bleeding profile and safety of women taking a DRSP only pill in a regime of 24 days of 4 mg of DRSP tablets followed by 4 days of placebo versus desogestrel 0.075 mg per day continuously over 9 cycles. A total of 858 women with 6691 drospirenone and 332 women with 2487 desogestrel treatment cycles were analyzed. The primary endpoint was the proportion of women with bleeding/spotting days in each cycle from cycles 2 to 9 and cumulative in cycles 2 to 4 and cycles 7 to 9 including and excluding those with amenorrhea.
FINDINGS


In each cycle, up to cycle 7, the proportion of women with unscheduled bleeding including those which did not bleed was statistically significantly lower in the DRSP group than in the DSG group (p = 0.0001, chi-square test). The mean [SD] number of unscheduled bleeding and spotting days during cycles 2-9 was statistically significantly lower in the DRSP group than in the DSG group (21.5 [22.86] days vs. 34.7 [33.73] days, p = 0.0003, Wilcoxon-rank-sum-test). Excluding amenorrhoeic women following results were obtained: In the cycles 2-6, the proportion of women with unscheduled bleeding was statistically significantly lower in the DRSP group than in the DSG group (p = 0.0001, chi-square test). The mean [SD] number of bleeding days was 8.6 [8.52] days vs. 12.9 [16.47] days, p = 0.0233.
CONCLUSIONS


This report describes the improvement in bleeding profile of women using the new DRSP only oral contraceptive in comparison to DSG providing a better quality of live and adherence to the contraceptive method. EudraCT registration number: 2011-002396-42.",2020,"In the cycles 2-6, the proportion of women with unscheduled bleeding was statistically significantly lower in the DRSP group than in the DSG group (p = 0.0001, chi-square test).","['858 women with 6691 drospirenone and 332 women with 2487 desogestrel treatment cycles were analyzed', 'healthy women aged 18 to 45 years', 'Excluding amenorrhoeic women following results were obtained']","['DRSP', 'placebo versus desogestrel', 'drospirenone (DRSP)-only pill', 'drospirenone', 'DRSP tablets', 'Desogestrel']","['mean [SD] number of bleeding days', 'proportion of women with unscheduled bleeding', 'bleeding profile and safety', 'quality of live and adherence', 'bleeding profile', 'proportion of women with bleeding/spotting days', 'proportion of women with unscheduled bleeding including those which did not bleed', 'mean [SD] number of unscheduled bleeding and spotting days']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}]","[{'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]",858.0,0.0815399,"In the cycles 2-6, the proportion of women with unscheduled bleeding was statistically significantly lower in the DRSP group than in the DSG group (p = 0.0001, chi-square test).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Palacios', 'Affiliation': 'Salud y Medicina de la Mujer, Director-Instituto Palacios, Madrid, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Colli', 'Affiliation': 'Exeltis HealthCare Madrid, Madrid, Spain.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Regidor', 'Affiliation': 'Exeltis Europe, Ismaning, Germany.'}]",PloS one,['10.1371/journal.pone.0231856']
1344,32608055,Can radiographic patellofemoral osteoarthritis be diagnosed using clinical assessments?,"INTRODUCTION


The aim of this study was to determine whether participant characteristics and clinical assessments could identify radiographic osteoarthritis (OA) in individuals with clinically diagnosed, symptomatic patellofemoral osteoarthritis (PFOA).
METHODS


Participant characteristics and clinical assessments were obtained from 179 individuals aged 50 years and over with clinically diagnosed symptomatic PFOA, who were enrolled in a randomised trial. Anteroposterior, lateral, and skyline X-rays were taken of the symptomatic knee. The presence of radiographic PFOA was defined as ""no or early PFOA"" (Kellgren and Lawrence [KL] grade ≤1 in the PF compartment) or ""definite PFOA"" (KL grade ≥2). Diagnostic test statistics were applied to ascertain which participant characteristics and clinical assessments could identify the presence of definite radiographic PFOA.
RESULTS


A total of 118 participants (66%) had definite radiographic PFOA. Univariate analysis identified that older age (>61 years), female sex, higher body mass index (BMI) (>29 kg/m 2  ), longer pain duration (>2.75 years), higher maximum knee pain during stair ambulation (>47/100 mm), and fewer repeated single step-ups to pain onset (<21) were associated with the presence of definite radiographic PFOA. Multivariate logistic regression indicated that BMI, pain duration, and repeated single step-ups to pain onset were independently associated with radiographic PFOA and identified the presence of definite radiographic PFOA with an overall accuracy of 73%.
CONCLUSION


In individuals over 50 years of age with a clinical diagnosis of PFOA, higher BMI, longer pain duration, and fewer repeated single step-ups to pain onset increased the likelihood of radiographic PFOA. However, overall diagnostic accuracy was modest, suggesting that radiographic PFOA cannot be confidently identified using these tests.",2020,"Multivariate logistic regression indicated that BMI, pain duration, and repeated single step-ups to pain onset were independently associated with radiographic PFOA and identified the presence of definite radiographic PFOA with an overall accuracy of 73%.
","['older age (>61 years), female sex, higher body mass index (BMI) (>29 kg/m 2  ), longer pain duration (>2.75 years), higher maximum knee pain during stair ambulation (>47/100 mm), and fewer repeated single step-ups to pain onset (<21', '118 participants (66%) had definite radiographic PFOA', '179 individuals aged 50 years and over with clinically diagnosed symptomatic PFOA, who were enrolled in a randomised trial', 'individuals with clinically diagnosed, symptomatic patellofemoral osteoarthritis (PFOA']",[],"['BMI, pain duration, and repeated single step-ups to pain onset', 'radiographic osteoarthritis (OA', 'overall diagnostic accuracy', 'radiographic PFOA']","[{'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517639', 'cui_str': '2.75'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C1542808', 'cui_str': 'Patellofemoral osteoarthritis'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1542808', 'cui_str': 'Patellofemoral osteoarthritis'}]",118.0,0.0692962,"Multivariate logistic regression indicated that BMI, pain duration, and repeated single step-ups to pain onset were independently associated with radiographic PFOA and identified the presence of definite radiographic PFOA with an overall accuracy of 73%.
","[{'ForeName': 'Jade M', 'Initials': 'JM', 'LastName': 'Tan', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Hylton B', 'Initials': 'HB', 'LastName': 'Menz', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Shannon E', 'Initials': 'SE', 'LastName': 'Munteanu', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Collins', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Harvi F', 'Initials': 'HF', 'LastName': 'Hart', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Joel W', 'Initials': 'JW', 'LastName': 'Donnar', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Gearoid', 'Initials': 'G', 'LastName': 'Cleary', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Isobel C', 'Initials': 'IC', 'LastName': ""O'Sullivan"", 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Liam R', 'Initials': 'LR', 'LastName': 'Maclachlan', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Derham', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Kay M', 'Initials': 'KM', 'LastName': 'Crossley', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}]",Musculoskeletal care,['10.1002/msc.1490']
1345,32607569,Safety and Effectiveness of Early Oral Hydration in Patients After Cardiothoracic Surgery.,"BACKGROUND


Patients fast after cardiothoracic surgery because of concerns for nausea, vomiting, dysphagia, and aspiration pneumonia; fasting, however, causes thirst, a distressing symptom. To our knowledge, no studies exist to guide hydration practices in this population.
OBJECTIVE


To determine the effect of early oral hydration on adverse events and thirst in patients after cardiothoracic surgery.
METHODS


This study applied a prospective 2-group design in which 149 patients from an 18-bed cardiothoracic intensive care unit were randomized to either usual care (a 6-hour fast) or early oral hydration after extubation. The research protocol involved nurses evaluating patients' readiness for oral hydration and then offering them ice chips. If patients tolerated the ice chips, they were allowed to drink water 1 hour later.
RESULTS


Most patients (91.3%) had undergone coronary artery or valve surgery, or both. Demographic and clinical variables were similar in both groups. No significant between-group differences were found for the incidence of nausea, vomiting, or dysphagia, and no aspiration pneumonia occurred. Significantly more patients with a high thirst level were in the usual care group (81.2%) than in the early oral hydration group (56.5%; P = .002, r2 test). After adjustment for demographic and clinical variables by using logistic regression, early oral hydration was independently and negatively associated with a high thirst level (odds ratio, 0.30 [95% CI, 0.13-0.69]; P = .004).
CONCLUSION


This research provides new evidence that oral hydration (ice chips and water) soon after extubation is safe and significantly reduces thirst in particular patients.",2020,"No significant between-group differences were found for the incidence of nausea, vomiting, or dysphagia, and no aspiration pneumonia occurred.","['149 patients from an 18-bed cardiothoracic intensive care unit', 'Patients', 'patients after cardiothoracic surgery']","['usual care (a 6-hour fast) or early oral hydration after extubation', 'Early Oral Hydration']","['incidence of nausea, vomiting, or dysphagia, and no aspiration pneumonia', 'undergone coronary artery or valve surgery', 'Safety and Effectiveness']","[{'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1274037', 'cui_str': 'Cardiothoracic surgery'}]","[{'cui': 'C1292428', 'cui_str': '6 hours'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0032290', 'cui_str': 'Aspiration pneumonia'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",149.0,0.0365417,"No significant between-group differences were found for the incidence of nausea, vomiting, or dysphagia, and no aspiration pneumonia occurred.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ford', 'Affiliation': 'About the Authors: Catherine Ford and Donna McCormick are clinical nurses; Katrien Derycke-Chapman, Judith Marshall, Jessica Mancarella, and Anne Chepulis are former clinical nurses in the cardiothoracic intensive care unit, Heart and Vascular Center, Yale New Haven Hospital, New Haven, Connecticut.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'McCormick', 'Affiliation': 'About the Authors: Catherine Ford and Donna McCormick are clinical nurses; Katrien Derycke-Chapman, Judith Marshall, Jessica Mancarella, and Anne Chepulis are former clinical nurses in the cardiothoracic intensive care unit, Heart and Vascular Center, Yale New Haven Hospital, New Haven, Connecticut.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Parkosewich', 'Affiliation': 'About the Authors: Catherine Ford and Donna McCormick are clinical nurses; Katrien Derycke-Chapman, Judith Marshall, Jessica Mancarella, and Anne Chepulis are former clinical nurses in the cardiothoracic intensive care unit, Heart and Vascular Center, Yale New Haven Hospital, New Haven, Connecticut.'}, {'ForeName': 'Katrien', 'Initials': 'K', 'LastName': 'Derycke-Chapman', 'Affiliation': 'About the Authors: Catherine Ford and Donna McCormick are clinical nurses; Katrien Derycke-Chapman, Judith Marshall, Jessica Mancarella, and Anne Chepulis are former clinical nurses in the cardiothoracic intensive care unit, Heart and Vascular Center, Yale New Haven Hospital, New Haven, Connecticut.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'About the Authors: Catherine Ford and Donna McCormick are clinical nurses; Katrien Derycke-Chapman, Judith Marshall, Jessica Mancarella, and Anne Chepulis are former clinical nurses in the cardiothoracic intensive care unit, Heart and Vascular Center, Yale New Haven Hospital, New Haven, Connecticut.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mancarella', 'Affiliation': 'About the Authors: Catherine Ford and Donna McCormick are clinical nurses; Katrien Derycke-Chapman, Judith Marshall, Jessica Mancarella, and Anne Chepulis are former clinical nurses in the cardiothoracic intensive care unit, Heart and Vascular Center, Yale New Haven Hospital, New Haven, Connecticut.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Chepulis', 'Affiliation': 'About the Authors: Catherine Ford and Donna McCormick are clinical nurses; Katrien Derycke-Chapman, Judith Marshall, Jessica Mancarella, and Anne Chepulis are former clinical nurses in the cardiothoracic intensive care unit, Heart and Vascular Center, Yale New Haven Hospital, New Haven, Connecticut.'}]","American journal of critical care : an official publication, American Association of Critical-Care Nurses",['10.4037/ajcc2020841']
1346,32604427,Association of Successful Ultrasound-Accelerated Catheter-Directed Thrombolysis with Postthrombotic Syndrome: A Post Hoc Analysis of the CAVA Trial.,"BACKGROUND


The CAVA trial did not show the anticipated risk reduction for postthrombotic syndrome (PTS) after thrombus removal via additional ultrasound-accelerated catheter-directed thrombolysis (UACDT) in patients with acute iliofemoral deep vein thrombosis (IFDVT). Difficulties in achieving an effective degree of recanalization through thrombolysis may have influenced outcomes. We therefore assessed whether successful UACDT (restored patency ≥ 90%) did reduce the development of PTS.
METHODS


This CAVA trial post hoc analysis compared the proportion of PTS at 1-year follow-up between patients with successful UACDT and patients that received standard treatment only. In addition, clinical impact as well as determinants of successful thrombolysis were explored.
RESULTS


UACDT was initiated in 77 (50.7%) patients and considered successful in 41 (53.2%, interrater agreement  κ  = 0.7, 95% confidence interval 0.47-0.83). PTS developed in 15/41 (36.6%) patients in the successful UACDT group versus 33/75 (44.0%) controls ( p  = 0.44). In this comparison, successful UACDT was associated with lower Venous Clinical Severity Score (3.50 ± 2.57 vs. 4.82 ± 2.74,  p  = 0.02) and higher EuroQOL-5D (EQ-5D) scores (40.2 ± 36.4 vs. 23.4 ± 34.4,  p  = 0.01). Compared with unsuccessful UACDT, successful UACDT was associated with a shorter symptom duration at inclusion ( p  = 0.05), and higher rates of performed adjunctive procedures ( p  < 0.001) and stent placement ( p  < 0.001).
CONCLUSION


Successful UACDT was not associated with a reduced proportion of PTS 1 year after acute IFDVT compared with patients receiving standard treatment alone. There was, however, a significant reduction in symptom severity and improvement of generic quality of life according to the EQ-5D. Better patient selection and optimization of treatment protocols are needed to assess the full potential of UACDT for the prevention of PTS.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov number, NCT00970619.",2020,Successful UACDT was not associated with a reduced proportion of PTS 1 year after acute IFDVT compared with patients receiving standard treatment alone.,"['patients with acute iliofemoral deep vein thrombosis (IFDVT', 'with Postthrombotic Syndrome']","['Successful Ultrasound-Accelerated Catheter-Directed Thrombolysis', 'thrombus removal via additional ultrasound-accelerated catheter-directed thrombolysis (UACDT']","['stent placement', 'Venous Clinical Severity Score', 'higher rates of performed adjunctive procedures', 'higher EuroQOL-5D (EQ-5D) scores', 'PTS', 'symptom severity and improvement of generic quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0340714', 'cui_str': 'Iliofemoral deep vein thrombosis'}, {'cui': 'C0032807', 'cui_str': 'Postthrombotic syndrome'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0522776', 'cui_str': 'Placement of stent'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032807', 'cui_str': 'Postthrombotic syndrome'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.355072,Successful UACDT was not associated with a reduced proportion of PTS 1 year after acute IFDVT compared with patients receiving standard treatment alone.,"[{'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Notten', 'Affiliation': 'Department of Vascular Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Carsten W K P', 'Initials': 'CWKP', 'LastName': 'Arnoldussen', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Rutger', 'Initials': 'R', 'LastName': 'Brans', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'André A E A', 'Initials': 'AAEA', 'LastName': 'de Smet', 'Affiliation': 'Department of Vascular Surgery, Maasstad Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Lidwine W', 'Initials': 'LW', 'LastName': 'Tick', 'Affiliation': 'Department of Internal Medicine, Maxima Medical Centre, Eindhoven, The Netherlands.'}, {'ForeName': 'Marlène H W', 'Initials': 'MHW', 'LastName': 'van de Poel', 'Affiliation': 'Department of Internal Medicine, Laurentius Hospital, Roermond, The Netherlands.'}, {'ForeName': 'Otmar R M', 'Initials': 'ORM', 'LastName': 'Wikkeling', 'Affiliation': 'Department of Vascular Surgery, Nij Smellinghe Hospital, Drachten, The Netherlands.'}, {'ForeName': 'Louis-Jean', 'Initials': 'LJ', 'LastName': 'Vleming', 'Affiliation': 'Department of Internal Medicine, Haga Hospital, The Hague, The Netherlands.'}, {'ForeName': 'Ad', 'Initials': 'A', 'LastName': 'Koster', 'Affiliation': 'Department of Internal Medicine, VieCuri Medical Centre, Venlo, The Netherlands.'}, {'ForeName': 'Kon-Siong G', 'Initials': 'KG', 'LastName': 'Jie', 'Affiliation': 'Department of Internal Medicine, Zuyderland Medical Centre, Sittard, The Netherlands.'}, {'ForeName': 'Esther M G', 'Initials': 'EMG', 'LastName': 'Jacobs', 'Affiliation': 'Department of Internal Medicine, Elkerliek Hospital, Helmond, The Netherlands.'}, {'ForeName': 'Harm P', 'Initials': 'HP', 'LastName': 'Ebben', 'Affiliation': 'Department of Vascular Surgery, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Planken', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Ten Cate', 'Affiliation': 'Cardiovascular Research Institute Maastricht (CARIM), School for Cardiovascular Diseases, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Cees H A', 'Initials': 'CHA', 'LastName': 'Wittens', 'Affiliation': 'Department of Vascular Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Arina J', 'Initials': 'AJ', 'LastName': 'Ten Cate-Hoek', 'Affiliation': 'Cardiovascular Research Institute Maastricht (CARIM), School for Cardiovascular Diseases, Maastricht University Medical Centre, Maastricht, The Netherlands.'}]",Thrombosis and haemostasis,['10.1055/s-0040-1713171']
1347,32605075,Lifestyle Intervention on Body Weight and Physical Activity in Patients with Breast Cancer can reduce the Risk of Death in Obese Women: The EMILI Study.,":  Background obesity and sedentary lifestyle have been shown to negatively affect survival in breast cancer (BC). The purpose of this study was to test the efficacy of a lifestyle intervention on body mass index (BMI) and physical activity (PA) levels among BC survivors in Modena, Italy, in order to show an outcome improvement in obese and overweight patients.
METHODS


This study is a single-arm experimental design, conducted between November 2009 and May 2016 on 430 women affected by BC. Weight, BMI, and PA were assessed at baseline, at 12 months, and at the end of the study. Survival curves were estimated among normal, overweight, and obese patients.
RESULTS


Mean BMI decreased from baseline to the end of the study was equal to 2.9% ( p  = 0.065) in overweight patients and 3.3% in obese patients ( p  = 0.048). Mean PA increase from baseline to the end of the study was equal to 125% ( p  < 0.001) in normal patients, 200% ( p  < 0.001) in overweight patients and 100% ( p  < 0.001) in obese patients. After 70 months of follow-up, the 5-year overall survival (OS) rate was 96%, 96%, and 93%, respectively in normal, obese, and overweight patients. Overweight patients had significantly worse OS than normal ones (HR = 3.69, 95%CI = 1.82-4.53  p  = 0.027) whereas no statistically significant differences were seen between obese and normal patients (HR 2.45, 95%CI = 0.68-8.78,  p  = 0.169).
CONCLUSIONS


A lifestyle intervention can lead to clinically meaningful weight loss and increase PA in patients with BC. These results could contribute to improving the OS in obese patients compared to overweight ones.",2020,"Overweight patients had significantly worse OS than normal ones (HR = 3.69, 95%CI = 1.82-4.53  p  = 0.027) whereas no statistically significant differences were seen between obese and normal patients (HR 2.45, 95%CI = 0.68-8.78,  p  = 0.169).
","['patients with BC', 'November 2009 and May 2016 on 430 women affected by BC', 'obese patients', 'Patients with Breast Cancer', 'obese and overweight patients', 'Obese Women']","['Lifestyle Intervention', 'lifestyle intervention']","['Weight, BMI, and PA', '5-year overall survival (OS) rate', 'body mass index (BMI) and physical activity (PA) levels', 'Mean BMI', 'Survival curves', 'Mean PA increase', 'Body Weight and Physical Activity', 'Risk of Death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",430.0,0.0353551,"Overweight patients had significantly worse OS than normal ones (HR = 3.69, 95%CI = 1.82-4.53  p  = 0.027) whereas no statistically significant differences were seen between obese and normal patients (HR 2.45, 95%CI = 0.68-8.78,  p  = 0.169).
","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cortesi', 'Affiliation': 'Department of Oncology and Hematology, Azienda Ospedaliero-Universitaria di Modena, 41124 Modena, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Sebastiani', 'Affiliation': 'Department of Oncology and Hematology, Azienda Ospedaliero-Universitaria di Modena, 41124 Modena, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Iannone', 'Affiliation': 'Department of Surgery, Medicine, Dentistry and Morphological Sciences with Transplant Surgery, Oncology and Regenerative Medicine Relevance, University of Modena and Reggio Emilia, 41124 Modena, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Marcheselli', 'Affiliation': 'Department of Oncology and Hematology, Azienda Ospedaliero-Universitaria di Modena, 41124 Modena, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Venturelli', 'Affiliation': 'Department of Oncology and Hematology, Azienda Ospedaliero-Universitaria di Modena, 41124 Modena, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Piombino', 'Affiliation': 'Department of Oncology and Hematology, Azienda Ospedaliero-Universitaria di Modena, 41124 Modena, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Toss', 'Affiliation': 'Department of Oncology and Hematology, Azienda Ospedaliero-Universitaria di Modena, 41124 Modena, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Federico', 'Affiliation': 'Department of Oncology and Hematology, Azienda Ospedaliero-Universitaria di Modena, 41124 Modena, Italy.'}]",Cancers,['10.3390/cancers12071709']
1348,32605121,Effects of Plyometric and Repeated Sprint Training on Physical Performance.,"The purpose of study was to resolve the effect of plyometric training and repeated sprint training on physical performance. The study was conducted on 41 subjects in two experimental groups (plyometric/repeated sprints training). Before and after the training program, subjects were subjected to diagnostic procedures that included standard test protocols. Results proved a statistically significant difference only after the plyometric training program compared to the repeated sprint group in countermovement jump (8.65% vs. 2.21%). In variable repeated jumps, an increased value was recorded (2.9% vs. 4.29%), like in sprint variables after the training program where certain trends of progress happened after the repeated sprint ability training and the specificity of the program (5 m = 0.89%, 10 m = 1.07% and 25 m = 1.35%), while plyometric training recorded unchanged values at 5 and 10 m, and a 0.27% improvement at 25 m. Stagnation of the 20-yard test was recorded in both groups. There was no difference between training programs in any variables of functional capacities, with similar measures recorded in repeated sprint ability. After six weeks of both training types, positive changes can be expected in explosive strength of lower extremities, increases in acceleration area, and maximum speed.",2020,"There was no difference between training programs in any variables of functional capacities, with similar measures recorded in repeated sprint ability.",['41 subjects in two experimental groups (plyometric/repeated sprints training'],"['Plyometric and Repeated Sprint Training', 'plyometric training and repeated sprint training']","['Physical Performance', 'explosive strength of lower extremities, increases in acceleration area, and maximum speed', 'physical performance']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0454374', 'cui_str': 'Sprint training'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0454374', 'cui_str': 'Sprint training'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015330', 'cui_str': 'Explosive device'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",41.0,0.0169028,"There was no difference between training programs in any variables of functional capacities, with similar measures recorded in repeated sprint ability.","[{'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Krakan', 'Affiliation': 'Faculty of Kinesiology, University of Zagreb, 10.000 Zagreb, Croatia.'}, {'ForeName': 'Luka', 'Initials': 'L', 'LastName': 'Milanovic', 'Affiliation': 'Faculty of Kinesiology, University of Zagreb, 10.000 Zagreb, Croatia.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Belcic', 'Affiliation': 'Faculty of Kinesiology, University of Zagreb, 10.000 Zagreb, Croatia.'}]","Sports (Basel, Switzerland)",['10.3390/sports8070091']
1349,32611648,"A Biomarker-enriched, Randomized Phase II Trial of Adavosertib (AZD1775) Plus Paclitaxel and Carboplatin for Women with Platinum-sensitive  TP53 -mutant Ovarian Cancer.","PURPOSE


Preclinical studies show that adavosertib, a WEE1 kinase inhibitor, sensitizes  TP53 -mutant cells to chemotherapy. We hypothesized that adavosertib, plus chemotherapy, would enhance efficacy versus placebo in  TP53 -mutated ovarian cancer.
PATIENTS AND METHODS


Following safety run-in, this double-blind phase II trial (NCT01357161) randomized women with  TP53 -mutated, platinum-sensitive ovarian cancer to oral adavosertib (225 mg twice daily for 2.5 days/21-day cycle) or placebo, plus carboplatin (AUC5) and paclitaxel (175 mg/m 2 ), until disease progression or for six cycles. The primary endpoints were progression-free survival (PFS) by enhanced RECIST v1.1 [ePFS (volumetric)] and safety. Secondary/exploratory objectives included PFS by RECIST v1.1 (single dimension), objective response rate, overall survival, and analysis of tumor gene profile versus sensitivity to adavosertib.
RESULTS


A total of 121 patients were randomized to adavosertib (A+C;  n  = 59) and placebo (P+C;  n  = 62) plus chemotherapy. Adding adavosertib to chemotherapy improved ePFS [median, 7.9 (95% confidence interval (CI), 6.9-9.9) vs. 7.3 months (5.6-8.2); HR 0.63 (95% CI, 0.38-1.06); two-sided  P  = 0.080], meeting the predefined significance threshold ( P  < 0.2). Clinical benefit was observed following A+C for patients with different  TP53  mutation subtypes, identifying possible response biomarkers. An increase in adverse events was seen with A+C versus P+C: greatest for diarrhea (adavosertib 75%; placebo 37%), vomiting (63%; 27%), anemia (53%; 32%), and all grade ≥3 adverse events (78%; 65%).
CONCLUSIONS


Establishing an optimal strategy for managing tolerability and identifying specific patient populations most likely to benefit from treatment may increase clinical benefit. Future studies should consider additional adavosertib doses within the chemotherapy treatment cycle and the potential for maintenance therapy.",2020,An increase in adverse events was seen with A+C versus P+C: greatest for diarrhea,"['women with platinum-sensitive  TP53 -mutant ovarian cancer', '121 patients', 'women with  TP53 -mutated, platinum-sensitive ovarian cancer to oral adavosertib (225 mg twice daily for 2.5 days/21-day cycle) or']","['adavosertib, plus chemotherapy', 'adavosertib (AZD1775) plus paclitaxel and carboplatin', 'placebo (P+C; n=62) plus chemotherapy', 'adavosertib (A+C', 'placebo, plus carboplatin (AUC5) and paclitaxel', 'placebo']","['diarrhea', 'progression-free survival (PFS) by enhanced RECIST v1.1 (ePFS [volumetric]) and safety', 'PFS by RECIST v1.1 (single dimension), objective response rate, overall survival, and analysis of tumor gene profile versus sensitivity to adavosertib', 'grade ≥3 adverse events', 'vomiting', 'anemia', 'adverse events', 'ePFS']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0079419', 'cui_str': 'Genes, TP53'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",121.0,0.652253,An increase in adverse events was seen with A+C versus P+C: greatest for diarrhea,"[{'ForeName': 'Amit M', 'Initials': 'AM', 'LastName': 'Oza', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Canada. amit.oza@uhn.ca.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Estevez-Diz', 'Affiliation': 'Instituto do Cancer do Estado de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Eva-Maria', 'Initials': 'EM', 'LastName': 'Grischke', 'Affiliation': 'Universitäts-Frauenklinik Tübingen, Tübingen, Germany.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, United Kingdom.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Marmé', 'Affiliation': 'Nationales Centrum für Tumorerkrankungen, Heidelberg, Germany.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Provencher', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Montreal, Canada.""}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Uyar', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Johanne I', 'Initials': 'JI', 'LastName': 'Weberpals', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Wenham', 'Affiliation': 'H Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Laing', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tracy', 'Affiliation': 'MT Statistics Ltd, East Kilbride, United Kingdom.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Freshwater', 'Affiliation': 'MRL, Merck & Co, Inc, Kenilworth, New Jersey.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Lee', 'Affiliation': 'MRL, Merck & Co, Inc, Kenilworth, New Jersey.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'MRL, Merck & Co, Inc, Kenilworth, New Jersey.'}, {'ForeName': 'Jingjun', 'Initials': 'J', 'LastName': 'Qiu', 'Affiliation': 'Merck Sharp & Dohme R&D, Beijing, China.'}, {'ForeName': 'Shelonitda', 'Initials': 'S', 'LastName': 'Rose', 'Affiliation': 'MRL, Merck & Co, Inc, Kenilworth, New Jersey.'}, {'ForeName': 'Eric H', 'Initials': 'EH', 'LastName': 'Rubin', 'Affiliation': 'MRL, Merck & Co, Inc, Kenilworth, New Jersey.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Moore', 'Affiliation': 'Stephenson Oklahoma Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0219']
1350,32613451,Muscle pain induced by hypertonic saline in the knee extensors decreases single-limb isometric time to task failure.,"PURPOSE


Increased nociceptive activity and the experience of exercise-induced pain (EIP) may contribute to fatigue during endurance exercise. To investigate this, a pain model that produces pain similar to EIP and decouples its relationship to exercise intensity is required. This study (1) compared the quality of pain caused by a hypertonic saline injection into the vastus lateralis in resting and exercise conditions, and (2) investigated whether this pain contributes to changes in time to task failure.
METHODS


On separate days, 18 participants completed a time to task failure at 20% maximal voluntary torque (MVT), a resting hypertonic saline intramuscular injection, and in a further three visits a time to task failure at 10% MVT following injection of isotonic saline, hypertonic saline or a control (no injection).
RESULTS


In a subset of eligible participants (n = 12), the hypertonic saline combined with 10% MVT produced a qualitative experience of pain (assessed by the McGill Pain Questionnaire) that felt similar to EIP. 10% MVT with hypertonic saline significantly elevated pain intensity in the first 20% of the time to task failure and caused a significantly (P < 0.05) shorter time to task failure (448 ± 240 s) compared with the isotonic saline (605 ± 285 s) and control (514 ± 197 s) conditions.
CONCLUSION


These findings demonstrate that hypertonic saline increases the intensity of pain during exercise, which results in a faster occurrence of exercise-induced fatigue. These results provide important evidence supporting pain as a limiting factor in endurance performance.",2020,"10% MVT with hypertonic saline significantly elevated pain intensity in the first 20% of the time to task failure and caused a significantly (P < 0.05) shorter time to task failure (448 ± 240 s) compared with the isotonic saline (605 ± 285 s) and control (514 ± 197 s) conditions.
",['18 participants completed a time to task failure at 20'],"['hypertonic saline combined with 10% MVT', 'maximal voluntary torque (MVT), a resting hypertonic saline intramuscular injection', 'isotonic saline, hypertonic saline or a control (no injection', 'exercise-induced pain (EIP', 'isotonic saline', 'hypertonic saline injection', 'hypertonic saline']","['quality of pain', 'knee extensors decreases single-limb isometric time to task failure', 'intensity of pain', 'elevated pain intensity', 'qualitative experience of pain', 'McGill Pain Questionnaire']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}]",,0.144328,"10% MVT with hypertonic saline significantly elevated pain intensity in the first 20% of the time to task failure and caused a significantly (P < 0.05) shorter time to task failure (448 ± 240 s) compared with the isotonic saline (605 ± 285 s) and control (514 ± 197 s) conditions.
","[{'ForeName': 'Samuel A', 'Initials': 'SA', 'LastName': 'Smith', 'Affiliation': 'Endurance Research Group, School of Sport and Exercise Sciences, University of Kent, Chatham, Kent, ME4 4AG, UK.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Micklewright', 'Affiliation': 'School of Sport, Rehabilitation and Exercise Sciences, University of Essex, Wivenhoe Park, Colchester, UK.'}, {'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Winter', 'Affiliation': 'Endurance Research Group, School of Sport and Exercise Sciences, University of Kent, Chatham, Kent, ME4 4AG, UK.'}, {'ForeName': 'Alexis R', 'Initials': 'AR', 'LastName': 'Mauger', 'Affiliation': 'Endurance Research Group, School of Sport and Exercise Sciences, University of Kent, Chatham, Kent, ME4 4AG, UK. lex.mauger@gmail.com.'}]",European journal of applied physiology,['10.1007/s00421-020-04425-2']
1351,32618242,Assessment of the Acceptability of Testing and Treatment during a Mass Drug Administration Trial for Malaria in Zambia Using Mixed Methods.,"From 2014 to 2016, a community-randomized controlled trial in Southern Province, Zambia, compared mass drug administration (MDA) and focal MDA (fMDA) with the standard of care. Acceptability of the intervention was assessed quantitatively using closed-ended and Likert scale-based questions posed during three household surveys conducted from April to May in 2014, 2015, and 2016 in 40 health catchments that implemented MDA and fMDA and 20 catchments that served as trial controls. In 2014 and 2015, 47 households per catchment were selected, targeting 1,880 households in MDA and fMDA trial arms; in 2016, 55 households per catchment were selected for a target of 2,200 households in MDA and fMDA trial arms. Concurrently, 27 focus group discussions and 23 in-depth interviews with 248 participants were conducted on reasons for testing and treatment refusal, reasons for nonadherence, and community perception of the MDA campaign. Results demonstrated that the MDA campaign was highly accepted with more than 99% of respondents stating that they would take treatment if positive for malaria. High acceptability at baseline could be associated with test-and-treat campaigns recently conducted in the study area. There was a large increase in the acceptability of prophylactic treatment if negative for malaria from the baseline to follow-up survey for adults and children, from 62% to 96% for each. This likely resulted from an intensive community-wide sensitization program that occurred before the first treatment round at each household during community health worker visits.",2020,"There was a large increase in the acceptability of prophylactic treatment if negative for malaria from the baseline to follow-up survey for adults and children, from 62% to 96% for each.","['2014, 2015, and 2016 in 40 health catchments that implemented MDA and fMDA and 20 catchments that served as trial controls', 'In 2014 and 2015, 47 households per catchment were selected, targeting 1,880 households in MDA and fMDA trial arms; in 2016, 55 households per catchment were selected for a target of 2,200 households in MDA and fMDA trial arms', 'Malaria in Zambia Using Mixed Methods', 'From 2014 to 2016, a community-randomized controlled trial in Southern Province, Zambia, compared mass drug administration (MDA) and focal MDA (fMDA) with the standard of care']",[],[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]",[],[],248.0,0.0973838,"There was a large increase in the acceptability of prophylactic treatment if negative for malaria from the baseline to follow-up survey for adults and children, from 62% to 96% for each.","[{'ForeName': 'Kafula', 'Initials': 'K', 'LastName': 'Silumbe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Finn', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Jennings', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Chilumba', 'Initials': 'C', 'LastName': 'Sikombe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Chiyende', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Busiku', 'Initials': 'B', 'LastName': 'Hamainza', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Chizema Kawesha', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Earle', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Steketee', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0663']
1352,32618245,"A Longitudinal Cohort to Monitor Malaria Infection Incidence during Mass Drug Administration in Southern Province, Zambia.","Rigorous evidence of effectiveness is needed to determine where and when to apply mass drug administration (MDA) or focal MDA (fMDA) as part of a malaria elimination strategy. The Zambia National Malaria Elimination Centre recently completed a community-randomized controlled trial in Southern Province to evaluate MDA and fMDA for transmission reduction. To assess the role of MDA and fMDA on infection incidence, we enrolled a longitudinal cohort for an 18-month period of data collection including monthly malaria parasite infection detection based on polymerase chain reaction and compared time to first infection and cumulative infection incidence outcomes across study arms using Cox proportional hazards and negative binomial models. A total of 2,026 individuals from 733 households were enrolled and completed sufficient follow-up for inclusion in analysis. Infection incidence declined dramatically across all study arms during the period of study, and MDA was associated with reduced risk of first infection (hazards ratio: 0.36; 95% CI: 0.16-0.80) and cumulative infection incidence during the first rainy season (first 5 months of follow-up) (incidence rate ratio: 0.34; 95% CI: 0.12-0.95). No significant effect was found for fMDA or for either arm over the full study period. Polymerase chain reaction infection status at baseline was strongly associated with follow-up infection. The short-term effects of MDA suggest it may be an impactful accelerator of transmission reduction in areas with high coverage of case management and vector control and should be considered as part of a malaria elimination strategy.",2020,The short-term effects of MDA suggest it may be an impactful accelerator of transmission reduction in areas with high coverage of case management and vector control and should be considered as part of a malaria elimination strategy.,"['Southern Province, Zambia', '2,026 individuals from 733 households were enrolled and completed sufficient follow-up for inclusion in analysis']","['MDA', 'MDA and fMDA']","['Infection incidence', 'cumulative infection incidence', 'Polymerase chain reaction infection status', 'reduced risk of first infection']","[{'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0517627', 'cui_str': 'Infection status'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",2026.0,0.0828922,The short-term effects of MDA suggest it may be an impactful accelerator of transmission reduction in areas with high coverage of case management and vector control and should be considered as part of a malaria elimination strategy.,"[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Travis R', 'Initials': 'TR', 'LastName': 'Porter', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Mulenga C', 'Initials': 'MC', 'LastName': 'Mwenda', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Joshua O', 'Initials': 'JO', 'LastName': 'Yukich', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Finn', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Lungu', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Kafula', 'Initials': 'K', 'LastName': 'Silumbe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Mambwe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Chishimba', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Conceptor', 'Initials': 'C', 'LastName': 'Mulube', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Bridges', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Busiku', 'Initials': 'B', 'LastName': 'Hamainza', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Slutsker', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Steketee', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0657']
1353,32618247,"Impact of Four Rounds of Mass Drug Administration with Dihydroartemisinin-Piperaquine Implemented in Southern Province, Zambia.","Over the past decade, Zambia has made substantial progress against malaria and has recently set the ambitious goal of eliminating by 2021. In the context of very high vector control and improved access to malaria diagnosis and treatment in Southern Province, we implemented a community-randomized controlled trial to assess the impact of four rounds of community-wide mass drug administration (MDA) and household-level MDA (focal MDA) with dihydroartemisinin-piperaquine (DHAP) implemented between December 2014 and February 2016. The mass treatment campaigns achieved relatively good household coverage (63-79%), were widely accepted by the community (ranging from 87% to 94%), and achieved very high adherence to the DHAP regimen (81-96%). Significant declines in all malaria study end points were observed, irrespective of the exposure group, with the overall parasite prevalence during the peak transmission season declining by 87.2% from 31.3% at baseline to 4.0% in 2016 at the end of the trial. Children in areas of lower transmission (< 10% prevalence at baseline) that received four MDA rounds had a 72% (95% CI = 12-91%) reduction in malaria parasite prevalence as compared with those with the standard of care without any mass treatment. Mass drug administration consistently had the largest short-term effect size across study end points in areas of lower transmission following the first two MDA rounds. In the context of achieving very high vector control coverage and improved access to diagnosis and treatment for malaria, our results suggest that MDA should be considered for implementation in African settings for rapidly reducing malaria outcomes in lower transmission settings.",2020,"Significant declines in all malaria study end points were observed, irrespective of the exposure group, with the overall parasite prevalence during the peak transmission season declining by 87.2% from 31.3% at baseline to 4.0% in 2016 at the end of the trial.","['Southern Province', 'Southern Province, Zambia']","['community-wide mass drug administration (MDA) and household-level MDA (focal MDA) with dihydroartemisinin-piperaquine (DHAP', 'Dihydroartemisinin-Piperaquine', 'MDA']","['malaria parasite prevalence', 'overall parasite prevalence']","[{'cui': 'C0043445', 'cui_str': 'Zambia'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}]","[{'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0868305,"Significant declines in all malaria study end points were observed, irrespective of the exposure group, with the overall parasite prevalence during the peak transmission season declining by 87.2% from 31.3% at baseline to 4.0% in 2016 at the end of the trial.","[{'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Kafula', 'Initials': 'K', 'LastName': 'Silumbe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Finn', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Travis R', 'Initials': 'TR', 'LastName': 'Porter', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Chalwe', 'Affiliation': 'Institute for Medical Research and Training, University Teaching Hospital, Lusaka, Zambia.'}, {'ForeName': 'Busiku', 'Initials': 'B', 'LastName': 'Hamainza', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Hawela', 'Initials': 'H', 'LastName': 'Moonga', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Kooma', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Chizema Kawesha', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Mulakwa', 'Initials': 'M', 'LastName': 'Kamuliwo', 'Affiliation': 'Zambia Ministry of Health, Southern Provincial Health Office, Choma, Zambia.'}, {'ForeName': 'Joshua O', 'Initials': 'JO', 'LastName': 'Yukich', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Keating', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Kammerle', 'Initials': 'K', 'LastName': 'Schneider', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Ruben O', 'Initials': 'RO', 'LastName': 'Conner', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Earle', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Slutsker', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Steketee', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0659']
1354,32619050,Super-mini percutaneous nephrolithotomy (PCNL) vs standard PCNL for the management of renal calculi of <2 cm: a randomised controlled study.,"OBJECTIVE


To compare the effectiveness and safety of standard percutaneous nephrolithotomy (sPCNL) and super-mini PCNL (SMP).
PATIENTS AND METHODS


A total of 150 patients presenting with renal calculi of <2 cm were randomised to either sPCNL (Group 1) or SMP (Group 2). Randomisation was based on centralised computer-generated numbers. Variables studied included: stone-free rates (SFRs), operative time, intra- and postoperative complications, postoperative pain score, analgesic requirement, and hospital stay. Statistical analysis was performed using a t-test or Mann-Whitney U-test for continuous variables and chi-squared test or Fisher's exact test for categorical variables.
RESULTS


Between September 2018 and April 2019, 75 patients were included in each group. The SFRs of the groups were similar (97.33 vs 98.66%, P = 0.56). The mean (sd) operative time was significantly longer in Group 2, at 36.40 (14.07) vs 23.12 (11.96) min (P < 0.001). The mean (sd) decrease in haemoglobin was significantly less in Group 2, at 3.0 (4.9) vs 7.5 (6.5) g/L (P < 0.001). The mean (sd) pain score at 24 h was significantly lower in Group 2, at 0.3 (0.46) vs 0.75 (0.53) (P < 0.001). The mean (sd) analgesic requirement was significantly less in Group 2, at 67 (22.49) vs 91.5 (30.56) mg tramadol (P < 0.001). The mean (sd) hospital stay was significantly less in Group 2, at 28.38 (3.6) vs 39.84 (3.7) h (P < 0.001).
CONCLUSIONS


SMP is equally as effective as sPCNL for managing renal calculi of <2 cm, with improved safety. Although SMP is associated with a longer operative time, it has a significantly lower incidence of bleeding and postoperative pain, and a shorter hospital stay.",2020,"The stone free rates in both groups were similar (97.33 vs 98.66%, p = 0.56).","['75 patients were included in each group', 'Between September 2018 and April 2019', 'renal calculi < 2 cm', '150 patients presenting with renal calculi < 2 cm']","['Super-mini Percutaneous Nephrolithotomy (SMP) vs Standard Percutaneous Nephrolithotomy (sPNL', 'SMP', 'standard and super-mini PNL (SMP']","['stone free rates, operating time, intra-operative and postoperative complications, postoperative pain score, analgesic requirement and hospital stay', 'stone free rates', 'efficacy and safety', 'Mean [SD] decrease in hemoglobin', 'Mean [SD] pain score', 'bleeding, postoperative pain score and lesser hospital stay', 'Mean [SD] operating time (minutes', 'Mean [SD] hospital stay (hours', 'Mean [SD] analgesic requirement (mg tramadol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]",75.0,0.0697676,"The stone free rates in both groups were similar (97.33 vs 98.66%, p = 0.56).","[{'ForeName': 'Raja Sekhar', 'Initials': 'RS', 'LastName': 'Guddeti', 'Affiliation': 'Department of Urology, Kasturba Hospital, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, India.'}, {'ForeName': 'Padmaraj', 'Initials': 'P', 'LastName': 'Hegde', 'Affiliation': 'Department of Urology, Kasturba Hospital, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, India.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Chawla', 'Affiliation': 'Department of Urology, Kasturba Hospital, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, India.'}, {'ForeName': 'Jean J M C H', 'Initials': 'JJMCH', 'LastName': 'de la Rosette', 'Affiliation': 'Department of Urology, Istanbul Medipol University, Istanbul, Turkey.'}, {'ForeName': 'Maria Pilar', 'Initials': 'MP', 'LastName': 'Laguna Pes', 'Affiliation': 'Department of Urology, Istanbul Medipol University, Istanbul, Turkey.'}, {'ForeName': 'Aseem', 'Initials': 'A', 'LastName': 'Kapadia', 'Affiliation': 'Department of Urology, Kasturba Hospital, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, India.'}]",BJU international,['10.1111/bju.15144']
1355,32619832,Definitive chemoradiotherapy plus cetuximab for cancer in the oesophagus or gastro-oesophageal junction.,"BACKGROUND


Chemoradiotherapy is standard treatment for localized oesophageal cancer unsuitable for surgery. We aimed to evaluate the efficacy of cetuximab in combination with chemoradiotherapy.
METHODS


This non-randomised multicentre phase II trial recruited patients aged 18-75 with WHO performance status 0-2 having squamous cell carcinoma or adenocarcinoma in the oesophagus or gastro-oesophageal junction, T2-4, N0-3, M0 not suitable for surgery. Chemotherapy was three 21-day cycles of fluorouracil 750 mg/m2 D1-5 and oxaliplatin D1 (cycle 1:130mg/m 2, cycle 2-3:85 mg/m 2). Radiotherapy was 50Gy in 2Gy/fraction, 5 days a week, concurrent with cycle 2 and 3 and weekly cetuximab. The primary objective was loco-regional control at one year.
RESULTS


52 patients were included. 51 were eligible for toxicity and survival analysis and 46 for recurrence analysis. Full radiotherapy dose was delivered to 80%, 75% received all three cycles of chemotherapy and 75% received four or more doses of cetuximab. The most common related grade III-IV adverse events were gastro-intestinal(16), hypersensitivity(6) and infection(5). There were two drug-related deaths. Within six months from the end of treatment, six patients died from complications from fistulas. The loco-regional control rate at one year was 47.3%(95%CI 30.9%-62.1%). Overall survival at three years was 29.1%(95% CI 17.4-41.9%).
CONCLUSIONS


Oxaliplatin and fluorouracil given concurrent with radiotherapy and cetuximab had an acceptable safety profile and showed a clinical response in patients with locoregionally advanced oesophageal cancer unsuitable for surgery. However, the primary end-point was not met, and the addition of cetuximab to definitive chemoradiotherapy cannot be recommended.",2020,"Overall survival at three years was 29.1%(95% CI 17.4-41.9%).
","['localized oesophageal cancer unsuitable for surgery', 'cancer in the oesophagus or gastro-oesophageal junction', 'patients with locoregionally advanced oesophageal cancer unsuitable for surgery', 'patients aged 18-75 with WHO performance status 0-2 having squamous cell carcinoma or adenocarcinoma in the oesophagus or gastro-oesophageal junction, T2-4, N0-3, M0 not suitable for surgery', '52 patients were included']","['radiotherapy and cetuximab', 'Chemotherapy', 'Definitive chemoradiotherapy plus cetuximab', 'Oxaliplatin and fluorouracil', 'Full radiotherapy', 'cetuximab', 'Chemoradiotherapy', 'fluorouracil 750 mg/m2 D1-5 and oxaliplatin D1 (cycle 1:130mg', 'Radiotherapy']","['toxicity and survival analysis', 'Overall survival', 'loco-regional control at one year', 'loco-regional control rate']","[{'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0546837', 'cui_str': 'Malignant tumor of esophagus'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4082117', 'cui_str': 'One year'}]",52.0,0.16028,"Overall survival at three years was 29.1%(95% CI 17.4-41.9%).
","[{'ForeName': 'Gabriella Alexandersson', 'Initials': 'GA', 'LastName': 'von Döbeln', 'Affiliation': 'Theme Cancer, Karolinska University Hospital, Stockholm, Sweden. Electronic address: gabriella.alexandersson-vondobeln@sll.se.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Wagenius', 'Affiliation': 'Theme Cancer, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Holtved', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Anne-Birgitte', 'Initials': 'AB', 'LastName': 'Jacobsen', 'Affiliation': 'Department of Oncology, Oslo University hospital, Oslo, Norway.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Nilsson', 'Affiliation': 'Department of Clinical Sciences Intervention and Technology Karolinska Institutet Division of Upper Abdominal Cancer, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Jingru', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Baeksgaard', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen, Denmark.'}]",Cancer treatment and research communications,['10.1016/j.ctarc.2020.100187']
1356,32620370,Evaluation of effectiveness of three-dimensional printed ear splint therapy following ear elevation surgery in microtia patients: A randomized controlled trial.,"AIM


This study aimed to compare the effectiveness of a 3D-printed ear splint with that of a conventional thermoplastic ear splint after microtia reconstruction.
METHODS


Patients who underwent ear elevation surgery with postauricular fascia coverage between October 2017 and October 2018 were included. They were randomly divided into the experimental group (3D-printed ear splint) and the control group (thermoplastic ear splint) and underwent routine postoperative rehabilitation and antiscar therapy. Splint therapy was initiated 4 weeks postoperatively and continued until 24 weeks postoperatively. The evaluated indices were the Vancouver scar scale score (VSS score), cranioauricular distance, patient compliance, complications (dermatitis, skin ulcers, skin necrosis), and patient satisfaction. A two-group t-test was carried out to compare all variables except patient satisfaction, which was compared using the Mann-Whitney U-test; p < 0.05 was considered significant.
RESULTS


Twenty patients were included in each group. At 4 weeks postoperatively, the VSS score (p = 0.748) and cranioauricular distance (p = 0.647) showed no significant differences between the groups. At 24 weeks postoperatively, the mean VSS scores were 4.85 ± 1.46 and 6.25 ± 1.74 (p = 0.009), the mean cranioauricular distances were 15.80 ± 1.82 mm and 13.95 ± 1.93 mm (p = 0.004), and the patient satisfaction scores were 4.5 ± 0.51 and 3.7 ± 0.47 (p < 0.001) in the experimental group and the control group, respectively, all showing significant differences. Two patients in each group exhibited skin irritation or skin ulcers, which resolved after 6 months of follow-up.
CONCLUSION


The application of 3D-printed ear splints provides better inhibition of scar contracture, better maintenance of ear projection and higher patient satisfaction than conventional ear splints following ear elevation surgery in microtia patients. Therefore, 3D-printed ear splints should be preferred over conventional ear splints whenever possible.",2020,"At 4 weeks postoperatively, the VSS score (p = 0.748) and cranioauricular distance (p = 0.647) showed no significant differences between the groups.","['microtia patients', 'Twenty patients were included in each group', 'Patients who underwent ear elevation surgery with postauricular fascia coverage between October 2017 and October 2018 were included']","['Splint therapy', '3D-printed ear splint', 'three-dimensional printed ear splint therapy', 'conventional thermoplastic ear splint', 'conventional ear splints', 'control group (thermoplastic ear splint) and underwent routine postoperative rehabilitation and antiscar therapy']","['mean cranioauricular distances', 'mean VSS scores', 'skin irritation or skin ulcers', 'Vancouver scar scale score (VSS score), cranioauricular distance, patient compliance, complications (dermatitis, skin ulcers, skin necrosis), and patient satisfaction', 'VSS score', 'cranioauricular distance', 'patient satisfaction scores']","[{'cui': 'C0152423', 'cui_str': 'Microtia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0442168', 'cui_str': 'Postauricular'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}]","[{'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0152030', 'cui_str': 'Skin irritation'}, {'cui': 'C0037299', 'cui_str': 'Skin ulcer'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0151799', 'cui_str': 'Skin necrosis'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}]",20.0,0.0512882,"At 4 weeks postoperatively, the VSS score (p = 0.748) and cranioauricular distance (p = 0.647) showed no significant differences between the groups.","[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, People's Republic of China.""}, {'ForeName': 'Zin Mar', 'Initials': 'ZM', 'LastName': 'Aung', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, People's Republic of China.""}, {'ForeName': 'Sousan', 'Initials': 'S', 'LastName': 'Cheong', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, People's Republic of China.""}, {'ForeName': 'Taeho', 'Initials': 'T', 'LastName': 'Won', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, People's Republic of China.""}, {'ForeName': 'Ruhong', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, People's Republic of China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, People's Republic of China.""}, {'ForeName': 'Jiajun', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, People's Republic of China. Electronic address: fanjj3177@sh9hospital.org.""}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, People's Republic of China. Electronic address: handong12000@163.com.""}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2020.06.003']
1357,32627271,The impact of the glucagon-like peptide-1 receptor agonist liraglutide on natriuretic peptides in heart failure patients with reduced ejection fraction with and without type 2 diabetes.,"AIM


To assess the effect of liraglutide, a glucagon-like peptide-1 receptor agonist, on urinary sodium excretion as well as on circulating adrenomedullin and copeptin levels in patients with type 2 diabetes (T2D).
MATERIALS AND METHODS


In the LIVE study, patients (n = 241) with left ventricular ejection fraction ≤45% were randomized to liraglutide 1.8 mg daily or placebo for 24 weeks, and 30% had a concomitant diagnosis of T2D. Plasma levels of N-terminal brain-natriuretic-peptide (NT-proBNP) (a predefined secondary endpoint), midregional pro-atrial-natriuretic-peptide (MR-proANP), midregional pro-adrenomedullin (MR-proADM) and copeptin were measured at baseline and after 24 weeks in this substudy. The potential effect modification of T2D was assessed.
RESULTS


In the eligible subgroup of 231 patients with available biomarkers (115 randomized to liraglutide and 116 to placebo), MR-proANP decreased by 12% (P = .002) and NT-proBNP by 9% (P = .009) during liraglutide treatment compared with placebo at week 24. Interaction with T2D for the treatment effect of change in MR-proANP and NT-proBNP levels was P = .003 and P = .03, respectively. Consequently, in patients with T2D, liraglutide decreased MR-proANP by 27% (P < .001) and NT-proBNP by 25% (P = .02) compared with placebo, whereas no change was observed in patients without T2D. There was no effect of liraglutide on MR-proADM (P = .10) or copeptin (P = .52).
CONCLUSION


Liraglutide decreased the A- and B-type natriuretic peptides significantly in patients with heart failure with reduced ejection fraction (HFrEF) and concomitant T2D, suggesting a beneficial mechanism of liraglutide in T2D patients with HFrEF.",2020,"There was no effect of liraglutide on MR-proADM (P=0.10) or copeptin (P=0.52).
","['T2D patients with HFrEF', 'patients with type 2 diabetes (T2D', 'Heart Failure Patients with Reduced Ejection Fraction with and without Type 2 Diabetes', 'patients (n=241) with LVEF≤45', 'heart failure patients with reduced ejection fraction (HFrEF', '231 patients with available biomarkers (115 randomized to']","['liraglutide 1.8 mg daily or placebo', 'liraglutide', 'Liraglutide', 'Glucagon-like peptide-1 receptor agonist liraglutide', 'Glucagon-Like Peptide-1 Receptor Agonist Liraglutide', 'placebo']","['MR-proANP', 'NT-proBNP', 'MR-proANP and NT-proBNP levels', 'A- and B-type natriuretic peptides', 'MR-proADM', 'concomitant diagnosis of T2D. Plasma levels of NT-proBNP (predefined secondary endpoint), MR-proANP, midregional-pro-adrenomedullin (MR-proADM) and copeptin']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4517540', 'cui_str': '115'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0027481', 'cui_str': 'A-type natriuretic peptide'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0215825', 'cui_str': 'ADM(1-52)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0056279', 'cui_str': 'copeptins'}]",231.0,0.132527,"There was no effect of liraglutide on MR-proADM (P=0.10) or copeptin (P=0.52).
","[{'ForeName': 'Roni', 'Initials': 'R', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Jorsal', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Rasmus S', 'Initials': 'RS', 'LastName': 'Tougaard', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jon J', 'Initials': 'JJ', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Endocrinology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Videbaek', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Fredriksberg University Hospital, Fredriksberg, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Faber', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Flyvbjerg', 'Affiliation': 'Steno Diabetes Center, Copenhagen, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Wiggers', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Tarnow', 'Affiliation': 'Steno Diabetes Center Sjaelland, Holbaek, Denmark.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Kistorp', 'Affiliation': 'Department of Endocrinology, Rigshospitalet, Copenhagen, Denmark.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14135']
1358,32622394,"Ambulatory management of primary spontaneous pneumothorax: an open-label, randomised controlled trial.","BACKGROUND


Primary spontaneous pneumothorax occurs in otherwise healthy young patients. Optimal management is not defined and often results in prolonged hospitalisation. Data on efficacy of ambulatory options are poor. We aimed to describe the duration of hospitalisation and safety of ambulatory management compared with standard care.
METHODS


In this open-label, randomised controlled trial, adults (aged 16-55 years) with symptomatic primary spontaneous pneumothorax were recruited from 24 UK hospitals during a period of 3 years. Patients were randomly assigned (1:1) to treatment with either an ambulatory device or standard guideline-based management (aspiration, standard chest tube insertion, or both). The primary outcome was total length of hospital stay including re-admission up to 30 days after randomisation. Patients with available data were included in the primary analysis and all assigned patients were included in the safety analysis. The trial was prospectively registered with the International Standard Randomised Clinical Trials Number, ISRCTN79151659.
FINDINGS


Of 776 patients screened between July, 2015, and March, 2019, 236 (30%) were randomly assigned to ambulatory care (n=117) and standard care (n=119). At day 30, the median hospitalisation was significantly shorter in the 114 patients with available data who received ambulatory treatment (0 days [IQR 0-3]) than in the 113 with available data who received standard care (4 days [IQR 0-8]; p<0·0001; median difference 2 days [95% CI 1-3]). 110 (47%) of 236 patients had adverse events, including 64 (55%) of 117 patients in the ambulatory care arm and 46 (39%) of 119 in the standard care arm. All 14 serious adverse events occurred in patients who received ambulatory care, eight (57%) of which were related to the intervention, including an enlarging pneumothorax, asymptomatic pulmonary oedema, and the device malfunctioning, leaking, or dislodging.
INTERPRETATION


Ambulatory management of primary spontaneous pneumothorax significantly reduced the duration of hospitalisation including re-admissions in the first 30 days, but at the expense of increased adverse events. This data suggests that primary spontaneous pneumothorax can be managed for outpatients, using ambulatory devices in those who require intervention.
FUNDING


UK National Institute for Health Research.",2020,"INTERPRETATION


Ambulatory management of primary spontaneous pneumothorax significantly reduced the duration of hospitalisation including re-admissions in the first 30 days, but at the expense of increased adverse events.","['Patients with available data were included in the primary analysis and all assigned patients were included in the safety analysis', '110 (47%) of 236 patients had adverse events, including 64 (55%) of 117 patients in the ambulatory care arm and 46 (39%) of 119 in the standard care arm', '776 patients screened between July, 2015, and March, 2019, 236 (30%) were randomly assigned to ambulatory care (n=117) and standard care (n=119', 'primary spontaneous pneumothorax', 'adults (aged 16-55 years) with symptomatic primary spontaneous pneumothorax were recruited from 24 UK hospitals during a period of 3 years', 'otherwise healthy young patients']","['ambulatory device or standard guideline-based management (aspiration, standard chest tube insertion, or both', 'ambulatory management compared with standard care']","['duration of hospitalisation including re-admissions', 'total length of hospital stay including re-admission', 'adverse events', 'median hospitalisation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1868193', 'cui_str': 'Primary spontaneous pneumothorax'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0189476', 'cui_str': 'Insertion of pleural tube drain'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.148264,"INTERPRETATION


Ambulatory management of primary spontaneous pneumothorax significantly reduced the duration of hospitalisation including re-admissions in the first 30 days, but at the expense of increased adverse events.","[{'ForeName': 'Rob J', 'Initials': 'RJ', 'LastName': 'Hallifax', 'Affiliation': 'Oxford Centre for Respiratory Medicine, University of Oxford, Oxford, UK. Electronic address: robert.hallifax@ndm.ox.ac.uk.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'McKeown', 'Affiliation': 'Royal Berkshire National Health Service (NHS) Foundation Trust, Reading, UK.'}, {'ForeName': 'Parthipan', 'Initials': 'P', 'LastName': 'Sivakumar', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Fairbairn', 'Affiliation': 'Queen Margaret Hospital, NHS Fife, Dunfermline, UK.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Peter', 'Affiliation': 'Royal United Hospitals Bath NHS Foundation Trust, Bath, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Leitch', 'Affiliation': 'Western General Hospital, NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Knight', 'Affiliation': 'West Hertfordshire Hospitals NHS Trust, Watford, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Stanton', 'Affiliation': 'Great Western Hospital NHS Foundation Trust, Swindon, UK.'}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Ijaz', 'Affiliation': 'University Hospitals of Morecambe Bay NHS Foundation Trust, Lancaster, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Marciniak', 'Affiliation': 'Department of Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Cameron', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Amrithraj', 'Initials': 'A', 'LastName': 'Bhatta', 'Affiliation': 'Blackpool Fylde and Wyre Hospitals NHS Foundation Trust, Blackpool, UK.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Blyth', 'Affiliation': 'Queen Elizabeth University Hospital, Glasgow, UK; Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Reddy', 'Affiliation': 'Kettering General Hospital, Kettering, UK.'}, {'ForeName': 'Marie-Clare', 'Initials': 'MC', 'LastName': 'Harris', 'Affiliation': 'Royal Infirmary of Edinburgh, NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Nadeem', 'Initials': 'N', 'LastName': 'Maddekar', 'Affiliation': 'University Hospitals of North Midlands, Stoke-on-Trent, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Walker', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'West', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Laskawiec-Szkonter', 'Affiliation': 'Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Corcoran', 'Affiliation': 'University Hospitals Plymouth NHS Trust, Plymouth, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gerry', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Corran', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Harvey', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Maskell', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, UK.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Miller', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Najib M', 'Initials': 'NM', 'LastName': 'Rahman', 'Affiliation': 'Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31043-6']
1359,32622397,Thulium laser transurethral vaporesection of the prostate versus transurethral resection of the prostate for men with lower urinary tract symptoms or urinary retention (UNBLOCS): a randomised controlled trial.,"BACKGROUND


Transurethral resection of the prostate (TURP) is the standard operation for benign prostatic obstruction. Thulium laser transurethral vaporesection of the prostate (ThuVARP) is a technique with suggested advantages over TURP, including reduced complications and hospital stay. We aimed to investigate TURP versus ThuVARP in men with lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction.
METHODS


In this randomised, blinded, parallel-group, pragmatic equivalence trial, men in seven UK hospitals with bothersome lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction were randomly assigned (1:1) at the point of surgery to receive ThuVARP or TURP. Patients were masked until follow-up completion. Centres used their usual TURP procedure (monopolar or bipolar). All trial surgeons underwent training on the ThuVARP technique. Co-primary outcomes were maximum urinary flow rate (Qmax) and International Prostate Symptom Score (IPSS) at 12-months post-surgery. Equivalence was defined as a difference of 2·5 points or less for IPSS and 4 mL per s or less for Qmax. Analysis was done according to the intention-to-treat principle. The trial is registered with the ISRCTN Registry, ISRCTN00788389.
FINDINGS


Between July 23, 2014, and Dec 30, 2016, 410 men were randomly assigned to ThuVARP or TURP, 205 per study group. TURP was superior for Qmax (mean 23·2 mL per s for TURP and 20·2 mL per s for ThuVARP; adjusted difference in means -3·12, 95% CI -5·79 to -0·45). Equivalence was shown for IPSS (mean 6·3 for TURP and 6·4 for ThuVARP; adjusted difference in means 0·28, -0·92 to 1·49). Mean hospital stay was 48 h in both study groups. 91 (45%) of 204 patients in the TURP group and 96 (47%) of 203 patients in the ThuVARP group had at least one complication.
INTERPRETATION


TURP and ThuVARP were equivalent for urinary symptom improvement (IPSS) 12-months post-surgery, and TURP was superior for Qmax. Anticipated laser benefits for ThuVARP of reduced hospital stay and complications were not observed.
FUNDING


UK National Institute for Health Research Health Technology Assessment Programme.",2020,"INTERPRETATION


TURP and ThuVARP were equivalent for urinary symptom improvement (IPSS) 12-months post-surgery, and TURP was superior for Qmax.","['men in seven UK hospitals with bothersome lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction', 'Between July 23, 2014, and Dec 30, 2016, 410 men', 'men with lower urinary tract symptoms or urinary retention (UNBLOCS', 'men with lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction']","['TURP', 'ThuVARP technique', 'ThuVARP', 'Thulium laser transurethral vaporesection of the prostate versus transurethral resection', 'ThuVARP or TURP', 'TURP versus ThuVARP', 'Transurethral resection of the prostate (TURP', 'usual TURP procedure (monopolar or bipolar', 'Thulium laser transurethral vaporesection of the prostate (ThuVARP']","['maximum urinary flow rate (Qmax) and International Prostate Symptom Score (IPSS', 'Mean hospital stay', 'hospital stay and complications']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0268889', 'cui_str': 'Prostatic obstruction'}]","[{'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040066', 'cui_str': 'Thulium'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0429783', 'cui_str': 'Urinary flow rate'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",410.0,0.20003,"INTERPRETATION


TURP and ThuVARP were equivalent for urinary symptom improvement (IPSS) 12-months post-surgery, and TURP was superior for Qmax.","[{'ForeName': 'Hashim', 'Initials': 'H', 'LastName': 'Hashim', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, North Bristol NHS Trust, Bristol, UK. Electronic address: h.hashim@gmail.com.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Worthington', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Abrams', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Young', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Taylor', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sian M', 'Initials': 'SM', 'LastName': 'Noble', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sara T', 'Initials': 'ST', 'LastName': 'Brookes', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Cotterill', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Page', 'Affiliation': 'Department of Urology, Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'K Satchi', 'Initials': 'KS', 'LastName': 'Swami', 'Affiliation': 'Urology Department, Aberdeen Royal Infirmary, NHS Grampian, Aberdeen, UK.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30537-7']
1360,32618249,"Cost-Effectiveness of Focal Mass Drug Administration and Mass Drug Administration with Dihydroartemisinin-Piperaquine for Malaria Prevention in Southern Province, Zambia: Results of a Community-Randomized Controlled Trial.","Community-wide administration of antimalarial drugs in therapeutic doses is a potential tool to prevent malaria infection and reduce the malaria parasite reservoir. To measure the effectiveness and cost of using the antimalarial drug combination dihydroartemisinin-piperaquine (DHAp) through different community-wide distribution strategies, Zambia's National Malaria Control Centre conducted a three-armed community-randomized controlled trial. The trial arms were as follows: 1) standard of care (SoC) malaria interventions, 2) SoC plus focal mass drug administration (fMDA), and 3) SoC plus MDA. Mass drug administration consisted of offering all eligible individuals DHAP, irrespective of a rapid diagnostic test (RDT) result. Focal mass drug administration consisted of offering DHAP to all eligible individuals who resided in a household where anyone tested positive by RDT. Results indicate that the costs of fMDA and MDA per person targeted and reached are similar (US$9.01 versus US$8.49 per person, respectively,  P  = 0.87), but that MDA was superior in all cost-effectiveness measures, including cost per infection averted, cost per case averted, cost per death averted, and cost per disability-adjusted life year averted. Subsequent costing of the MDA intervention in a non-trial, operational setting yielded significantly lower costs per person reached (US$2.90). Mass drug administration with DHAp also met the WHO thresholds for ""cost-effective interventions"" in the Zambian setting in 90% of simulations conducted using a probabilistic sensitivity analysis based on trial costs, whereas fMDA met these criteria in approximately 50% of simulations. A sensitivity analysis using costs from operational deployment and trial effectiveness yielded improved cost-effectiveness estimates. Mass drug administration may be a cost-effective intervention in the Zambian context and can help reduce the parasite reservoir substantially. Mass drug administration was more cost-effective in relatively higher transmission settings. In all scenarios examined, the cost-effectiveness of MDA was superior to that of fMDA.",2020,"Mass drug administration with DHAp also met the WHO thresholds for ""cost-effective interventions"" in the Zambian setting in 90% of simulations conducted using a probabilistic sensitivity analysis based on trial costs, whereas fMDA met these criteria in approximately 50% of simulations.","['Southern Province, Zambia', 'eligible individuals who resided in a household where anyone tested positive by RDT']","['SoC plus focal mass drug administration (fMDA), and 3) SoC plus MDA', 'MDA intervention', 'Focal Mass Drug Administration and Mass Drug Administration with Dihydroartemisinin-Piperaquine', 'antimalarial drug combination dihydroartemisinin-piperaquine (DHAp']","['costs of fMDA and MDA', 'cost-effectiveness of MDA', 'cost-effectiveness estimates', 'cost per infection averted, cost per case averted, cost per death averted, and cost per disability-adjusted life year averted']","[{'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0206743', 'cui_str': 'Malignant rhabdoid tumor'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0003374', 'cui_str': 'Antimalarial'}, {'cui': 'C0012324', 'cui_str': 'Dihydroxyacetone 3-Phosphate'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.139118,"Mass drug administration with DHAp also met the WHO thresholds for ""cost-effective interventions"" in the Zambian setting in 90% of simulations conducted using a probabilistic sensitivity analysis based on trial costs, whereas fMDA met these criteria in approximately 50% of simulations.","[{'ForeName': 'Joshua O', 'Initials': 'JO', 'LastName': 'Yukich', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Callie', 'Initials': 'C', 'LastName': 'Scott', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Seattle, Washington.'}, {'ForeName': 'Kafula', 'Initials': 'K', 'LastName': 'Silumbe', 'Affiliation': 'PATH MACEPA, Lusaka, Zambia.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Larson', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Finn', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Busiku', 'Initials': 'B', 'LastName': 'Hamainza', 'Affiliation': 'National Malaria Control Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Ruben O', 'Initials': 'RO', 'LastName': 'Conner', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Seattle, Washington.'}, {'ForeName': 'Travis R', 'Initials': 'TR', 'LastName': 'Porter', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Keating', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Steketee', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Seattle, Washington.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH MACEPA, Lusaka, Zambia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0661']
1361,32618251,"Treatment Coverage Estimation for Mass Drug Administration for Malaria with Dihydroartemisinin-Piperaquine in Southern Province, Zambia.","Mass drug administration (MDA) is currently being considered as an intervention in low-transmission areas to complement existing malaria control and elimination efforts. The effectiveness of any MDA strategy is dependent on achieving high epidemiologic coverage and participant adherence rates. A community-randomized controlled trial was conducted from November 2014 to March 2016 to evaluate the impact of four rounds of MDA or focal MDA (fMDA)-where treatment was given to all eligible household members if anyone in the household had a positive malaria rapid diagnostic test-on malaria outcomes in Southern Province, Zambia (population approximately 300,000). This study examined epidemiologic coverage and program reach using capture-recapture and satellite enumeration methods to estimate the degree to which the trial reached targeted individuals. Overall, it was found that the percentage of households visited by campaign teams ranged from 62.9% (95% CI: 60.0-65.8) to a high of 77.4% (95% CI: 73.8-81.0) across four rounds of treatment. When the maximum number of visited households across all campaign rounds was used as the numerator, program reach for at least one visit would have been 86.4% (95% CI: 80.8-92.0) in MDA and 83.5% (95% CI: 78.0-89.1) in fMDA trial arms. As per the protocol, the trial provided dihydroartemisinin-piperaquine treatment to an average of 58.8% and 13.3% of the estimated population based on capture-recapture in MDA and fMDA, respectively, across the four rounds.",2020,"Overall, it was found that the percentage of households visited by campaign teams ranged from 62.9% (95% CI: 60.0-65.8) to a high of 77.4% (95% CI: 73.8-81.0) across four rounds of treatment.","['Malaria with Dihydroartemisinin-Piperaquine in Southern Province, Zambia', 'eligible household members if anyone in the household had a positive malaria rapid diagnostic test-on malaria outcomes in Southern Province, Zambia (population approximately 300,000']",['MDA or focal MDA (fMDA)-where treatment'],[],"[{'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}]","[{'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.101887,"Overall, it was found that the percentage of households visited by campaign teams ranged from 62.9% (95% CI: 60.0-65.8) to a high of 77.4% (95% CI: 73.8-81.0) across four rounds of treatment.","[{'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Finn', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Joshua O', 'Initials': 'JO', 'LastName': 'Yukich', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Travis R', 'Initials': 'TR', 'LastName': 'Porter', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lungu', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Busiku', 'Initials': 'B', 'LastName': 'Hamainza', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Chainama Hospital, Lusaka, Zambia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Chizema Kawesha', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Chainama Hospital, Lusaka, Zambia.'}, {'ForeName': 'Ruben O', 'Initials': 'RO', 'LastName': 'Conner', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Kafula', 'Initials': 'K', 'LastName': 'Silumbe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Steketee', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Keating', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0665']
1362,32618265,"Moving from Malaria Burden Reduction toward Elimination: An Evaluation of Mass Drug Administration in Southern Province, Zambia.","From December 2014 to February 2016, a cluster randomized controlled trial was carried out in 60 health facility catchment areas along Lake Kariba in Zambia's Southern Province. The trial sought to evaluate the impact of four rounds of a mass drug administration (MDA) intervention with dihydroartemisinin-piperaquine (DHAP) or focal MDA with DHAP at the household level compared with a control population that received the standard of care. This study was the first randomized controlled trial with DHAP for MDA in sub-Saharan Africa and was conducted through a collaboration between the National Malaria Elimination Programme in the Zambian Ministry of Health, the PATH Malaria Control and Elimination Partnership in Africa, and the Center for Applied Malaria Research and Evaluation at Tulane University. This article serves as an introduction to a collection of articles designed to explore different aspects of the intervention. By describing the recent history of malaria control in Zambia leading up to the trial-from the scale-up of point-of-care diagnosis and treatment, vector control, and indoor residual spraying early in the twenty-first century, to the efforts made to sustain the gains achieved with that approach-it provides a rationale for the implementation of a trial that has informed a new national strategic plan and solidified malaria elimination as Zambia's national goal.",2020,"By describing the recent history of malaria control in Zambia leading up to the trial-from the scale-up of point-of-care diagnosis and treatment, vector control, and indoor residual spraying early in the twenty-first century, to the efforts made to sustain the gains achieved with that approach-it provides a rationale for the implementation of a trial that has informed a new national strategic plan and solidified malaria elimination as Zambia's national goal.","['sub-Saharan Africa and was conducted through a collaboration between the National Malaria Elimination Programme in the Zambian Ministry of Health, the PATH Malaria Control and Elimination Partnership in Africa, and the Center for Applied Malaria Research and Evaluation at Tulane University', ""60 health facility catchment areas along Lake Kariba in Zambia's Southern Province"", 'Southern Province, Zambia']","['Elimination', 'DHAP', 'mass drug administration (MDA) intervention with dihydroartemisinin-piperaquine (DHAP) or focal MDA with DHAP']",[],"[{'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0007403', 'cui_str': 'Health Catchment Area'}, {'cui': 'C0337049', 'cui_str': 'Lake'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}]","[{'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205234', 'cui_str': 'Focal'}]",[],,0.0505108,"By describing the recent history of malaria control in Zambia leading up to the trial-from the scale-up of point-of-care diagnosis and treatment, vector control, and indoor residual spraying early in the twenty-first century, to the efforts made to sustain the gains achieved with that approach-it provides a rationale for the implementation of a trial that has informed a new national strategic plan and solidified malaria elimination as Zambia's national goal.","[{'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Maya S', 'Initials': 'MS', 'LastName': 'Fraser', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Manuel T', 'Initials': 'MT', 'LastName': 'Lewis', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Slutsker', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Chizema Kawesha', 'Affiliation': 'National Malaria Control Centre, Zambia Ministry of Health, Lusaka, Zambia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0669']
1363,32618538,Influence of pre-schooler and parent nutrition education on carotenoid levels of Mexican-heritage children.,"OBJECTIVE


To determine the mediating effect of direct preschool and parent nutrition education on changes in skin carotenoids scores over 2 years in children of Mexican heritage.
DESIGN


In a quasi-experimental, community-based study, two school districts were randomly assigned to either a comparison group (parent workshops unrelated to nutrition) or a childhood obesity prevention intervention group which included nutrition education at family nights for parents and at school for children. Changes in skin carotenoid intensity scores (diffCAROT, year 2015 minus 2013) were measured in children as a proxy for fruit and vegetable consumption using Resonance Raman Spectroscopy.
SETTING


Two rural, low-income, school districts from a county in California's Central Valley.
PARTICIPANTS


316 Mexican heritage families with children aged 3-8 years.
RESULTS


Intervention group children improved over 2 years in skin carotenoid scores relative to comparison group children (diffCAROT mean +1419 (sd 9540) v. -3473 (sd 9272), P = 0·0001). Parent attendance at nutrition education classes partially mediated the intervention effect on diffCAROT (P = 0·02). Controlling for child's age and other covariates, participation in preschool during the study had a significant positive effect on diffCAROT among intervention children compared with controls (P < 0·03), whereas no significant difference by group was observed among those not enrolled in preschool or already enrolled in elementary school.
CONCLUSIONS


Programmes that combine direct parent and preschool nutrition education may be effective in low-income Mexican heritage families to improve children's intake of fruit and vegetables.",2020,"RESULTS


Intervention group children improved over 2 years in skin carotenoid scores relative to comparison group children (diffCAROT mean +1419 (sd 9540) v. -3473 (sd 9272), P = 0·0001).","['316 Mexican heritage families with children aged 3-8 years', ""Two rural, low-income, school districts from a county in California's Central Valley"", 'In a quasi-experimental, community-based study, two school districts', 'children of Mexican heritage', 'Mexican-heritage children']","['direct preschool and parent nutrition education', 'pre-schooler and parent nutrition education', 'comparison group (parent workshops unrelated to nutrition) or a childhood obesity prevention intervention group which included nutrition education at family nights for parents and at school for children']","['skin carotenoid scores', 'skin carotenoid intensity scores', 'skin carotenoids scores']","[{'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0563004', 'cui_str': 'Valley'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.0238306,"RESULTS


Intervention group children improved over 2 years in skin carotenoid scores relative to comparison group children (diffCAROT mean +1419 (sd 9540) v. -3473 (sd 9272), P = 0·0001).","[{'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'University of California Cooperative Extension, Yolo County, Woodland, CA95695, USA.'}, {'ForeName': 'Lucia L', 'Initials': 'LL', 'LastName': 'Kaiser', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Rosa D', 'Initials': 'RD', 'LastName': 'Manzo', 'Affiliation': 'Health Sciences Research Institute, University of California, Merced, CA, USA.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Aguilera', 'Affiliation': 'Department of Public Health, University of California, Merced, CA, USA.'}, {'ForeName': 'L Karina', 'Initials': 'LK', 'LastName': 'Diaz Rios', 'Affiliation': 'Division of Agriculture and Natural Resources, University of California, Merced, CA, USA.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Macias', 'Affiliation': 'University of California Cooperative Extension, Fresno County, CA, USA.'}]",Public health nutrition,['10.1017/S1368980019004579']
1364,32618884,Heart failure and renal outcomes according to baseline and achieved blood pressure in patients with type 2 diabetes: results from EMPA-REG OUTCOME.,"BACKGROUND


The sodium-glucose co-transporter 2 (SGLT2) inhibitor empagliflozin reduced cardiovascular death or heart failure hospitalizations in type 2 diabetes (T2D) in addition to a reduction of SBP. As heart failure patients often present with low SBP, which can challenge treatment initiation, we explored if empagliflozin's effect on SBP was independent of baseline SBP and heart failure status, and if the effect on cardiovascular and heart failure outcomes was influenced by updated mean SBP or by an early change in SBP after drug initiation.
METHODS AND RESULTS


A total of 7020 patients were treated with empagliflozin 10 mg, 25 mg or placebo and followed for a median of 3.1 years. All of them had BP measurement at baseline. We evaluated changes in SBP in the context of heart failure status at baseline and according to baseline SBP categories (<120, 120--<130, 130--<140, 140--<160, ≥160 mmHg). The updated mean SBP during the trial was calculated as a time-dependent variable. We then assessed the association of baseline and updated mean SBP with three-point major adverse cardiovascular events (3P-MACE), hospitalization for heart failure, cardiovascular death, hospitalization for heart failure or cardiovascular death, all-cause death, and incident/worsening nephropathy, and whether treatment effect of empagliflozin vs. placebo on these outcomes differed if adjusted for updated mean SBP. Finally, we evaluated the impact of early decline in SBP (≥5 mmHg at week 4) on the treatment effect of empagliflozin vs. placebo on these outcomes. Analyses were performed via Cox regression adjusting for baseline risk factors including a term for treatment subgroup interaction, and by landmark analyses starting at week 4. The difference in SBP reduction at week 12 between empagliflozin and placebo was 3--5 mmHg and similar regardless of baseline SBP category or HF status at baseline. Baseline SBP and updated mean SBP categories showed no association with cardiovascular outcomes, but was associated with new/worsening nephropathy. The treatment effects of empagliflozin on all explored outcomes were independent of updated mean SBP as well of the early drop in SBP on treatment.
CONCLUSION


In addition to decreasing SBP, empagliflozin reduced cardiovascular, heart failure and renal outcomes independently of updated mean SBP during the trial, and of the early SBP drop. These results suggest a BP-independent effect of empagliflozin on cardiovascular and heart failure outcomes. CLINICALTRIALS.
GOV IDENTIFIER


NCT01131676.",2020,"In addition to decreasing SBP, empagliflozin reduced cardiovascular, heart failure and renal outcomes independently of updated mean SBP during the trial, and of the early SBP drop.","['7020 patients', 'patients with type 2 diabetes']","['empagliflozin', 'empagliflozin vs. placebo', 'sodium-glucose co-transporter 2 (SGLT2) inhibitor empagliflozin', 'empagliflozin 10\u200amg, 25\u200amg or placebo', 'placebo']","['Heart failure and renal outcomes', 'SBP, empagliflozin reduced cardiovascular, heart failure and renal outcomes', 'blood pressure', 'cardiovascular and heart failure outcomes', 'cardiovascular death or heart failure hospitalizations', 'adverse cardiovascular events (3P-MACE), hospitalization for heart failure, cardiovascular death, hospitalization for heart failure or cardiovascular death, all-cause death, and incident/worsening nephropathy', 'SBP reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3848773', 'cui_str': 'empagliflozin 10 MG [Jardiance]'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",7020.0,0.0734859,"In addition to decreasing SBP, empagliflozin reduced cardiovascular, heart failure and renal outcomes independently of updated mean SBP during the trial, and of the early SBP drop.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Klinik für Innere Medizin III, Saarland University Medical Center, Homburg/Saar, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fitchett', 'Affiliation': ""St. Michael's Hospital, Division of Cardiology, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Anne Pernille', 'Initials': 'AP', 'LastName': 'Ofstad', 'Affiliation': 'Medical Department, Boehringer Ingelheim Ks, Asker, Norway.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Boehringer Ingelheim International GmbH & Co KG, Ingelheim.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kaspers', 'Affiliation': 'Boehringer Ingelheim International GmbH & Co KG, Ingelheim.'}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH & Co KG, Ingelheim.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Zwiener', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Department of Medicine, Wuerzburg University Clinic, Wuerzburg.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Marx', 'Affiliation': 'Department of Internal Medicine I, Cardiology, University Hospital Aachen, RWTH Aachen University Aachen, Germany.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Mancia', 'Affiliation': 'Clinica Medica, University of Milano-Bicocca, Ospedale San Gerardo, Monza, Italy.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK) and Berlin Institute of Health Center for Regenerative Therapies (BCRT).'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Mahfoud', 'Affiliation': 'Klinik für Innere Medizin III, Saarland University Medical Center, Homburg/Saar, Germany.'}]",Journal of hypertension,['10.1097/HJH.0000000000002492']
1365,32619458,"Acute psychological stress, autonomic function, and arterial stiffness among women.","This study aimed to investigate the effect of acute psychological stress on autonomic function and arterial stiffness, and to test a mediating role of changes in autonomic function between acute stress and arterial stiffness. Eighty-five healthy female adults were randomized into either an experimental or control group. The Trier Social Stress Test (TSST) was used to induce acute psychological stress. Autonomic function (measured by pre-ejection period [PEP] from cardiac impedance and high frequency [HF] of heart rate variability [HRV]) and arterial stiffness (measured by carotid and femoral pulse wave velocity [cfPWV] and augmentation index [AIx]) were assessed before and after the TSST. The mean age of the participants was 28.78 (±9.84) years old. Experimental group participants had a significant increase in cfPWV (p = .025) and AIx (p = .017) following the stressor, compared with those in the control group, after controlling for age, body mass index, and systolic blood pressure. However, no significant group differences were observed in changes in PEP (p = .181) and HF (p = .058). Changes in PEP and HF were neither associated with changes in cfPWV (p = .975 and p = .654, respectively), nor in AIx (p = .376 and p = .323, respectively). The results suggest that even a brief period of mild to moderate stress, which does not cause sustainable changes in autonomic function, may still exert significant adverse effects on arterial stiffness. The changes in arterial stiffness were not related to changes in autonomic function. Future experimental studies with several measurement points are recommended to identify distinct effects of stress on autonomic function and arterial stiffness.",2020,"Experimental group participants had a significant increase in cfPWV (p = .025) and AIx (p = .017) following the stressor, compared with those in the control group, after controlling for age, body mass index, and systolic blood pressure.","['The mean age of the participants was 28.78 (±9.84) years old', 'Eighty-five healthy female adults', 'women']",['Trier Social Stress Test (TSST'],"['heart rate variability [HRV]) and arterial stiffness (measured by carotid and femoral pulse wave velocity [cfPWV] and augmentation index [AIx', 'cfPWV', 'Autonomic function', 'Acute psychological stress, autonomic function, and arterial stiffness', 'arterial stiffness', 'autonomic function and arterial stiffness', 'systolic blood pressure', 'autonomic function', 'changes in PEP']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0686752', 'cui_str': 'Well female adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0232148', 'cui_str': 'Femoral pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0999177', 'cui_str': 'Aix'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031642', 'cui_str': 'Phosphoenolpyruvate'}]",85.0,0.0168326,"Experimental group participants had a significant increase in cfPWV (p = .025) and AIx (p = .017) following the stressor, compared with those in the control group, after controlling for age, body mass index, and systolic blood pressure.","[{'ForeName': 'Jeongok G', 'Initials': 'JG', 'LastName': 'Logan', 'Affiliation': 'University of Virginia, School of Nursing, McLeod Hall 4011, 225 Jeanette Lancaster Way, Charlottesville, VA 22903, United States. Electronic address: jl3zj@virginia.edu.'}, {'ForeName': 'Bethany A', 'Initials': 'BA', 'LastName': 'Teachman', 'Affiliation': 'University of Virginia, Department of Psychology, 207 Gilmer Hall, Charlottesville, VA 22903, United States. Electronic address: bat5x@virginia.edu.'}, {'ForeName': 'Xiaoyue', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'University of Virginia, School of Nursing, McLeod Hall 4034, 225 Jeanette Lancaster Way, Charlottesville, VA 22903, United States. Electronic address: xl5tb@virginia.edu.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Farber', 'Affiliation': 'University of Virginia, Public Health Sciences, OMS 3817B, Charlottesville, VA 22908, United States. Electronic address: crf2s@virginia.edu.'}, {'ForeName': 'Zhenqi', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'University of Virginia, School of Medicine, Suite 2100, 450 Ray C. Hunt Drive, Charlottesville, VA 22903, United States. Electronic address: zl3e@virginia.edu.'}, {'ForeName': 'Brian H', 'Initials': 'BH', 'LastName': 'Annex', 'Affiliation': 'Augusta University, Medical College of Georgia, 1120 15th St. Augusta, GA 30912, United States. Electronic address: bannex@augusta.edu.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.06.015']
1366,32619524,Design of a randomized placebo controlled trial of high dose intravenous thiamine for the prevention of delirium in allogeneic hematopoietic stem cell transplantation.,"BACKGROUND


Delirium is a highly prevalent and preventable neuropsychiatric condition with major health consequences. Thiamine deficiency is a well-established cause of delirium in those with chronic, severe alcoholism, but there remains an underappreciation of its significance in non-alcoholic populations, including patients with cancer. Treatment of suspected thiamine-related mental status changes with high dose intravenous (IV) thiamine has preliminary evidence for improving a variety of cognitive symptoms in oncology inpatient settings but has never been studied for the prevention of delirium in any population.
OBJECTIVES


The primary objective of this clinical trial is to determine if high dose IV thiamine can prevent delirium in patients receiving allogeneic hematopoietic stem cell transplantation (HSCT) for treatment of cancer. Secondary objectives are to determine if thiamine status is predictive of delirium onset and if high dose IV thiamine can attenuate the deleterious impact of delirium on health-related quality of life (HRQOL), functional status, and long-term neuropsychiatric outcomes.
METHODS


In this phase II study, we are recruiting 60 patients undergoing allogeneic HSCT, randomizing them to treatment with high dose IV thiamine (n = 30) versus placebo (n = 30), and systematically evaluating all participants for delirium and related comorbidities. We use the Delirium Rating Scale to measure the severity and duration of delirium during hospitalization for HSCT. We obtain thiamine levels weekly during the transplantation hospitalization. We assess HRQOL, functional status, depression, post-traumatic stress symptoms, and cognitive function prior to and at one, three, and six months after transplantation.",2020,"Treatment of suspected thiamine-related mental status changes with high dose intravenous (IV) thiamine has preliminary evidence for improving a variety of cognitive symptoms in oncology inpatient settings but has never been studied for the prevention of delirium in any population.
","['60 patients undergoing allogeneic HSCT, randomizing them to treatment with high dose', 'patients receiving allogeneic hematopoietic stem cell transplantation (HSCT) for treatment of cancer', 'Allogeneic Hematopoietic Stem Cell Transplantation', 'patients with cancer']","['Placebo', 'Thiamine', 'thiamine', 'intravenous (IV) thiamine', 'IV thiamine', 'placebo']","['HRQOL, functional status, depression, post-traumatic stress symptoms, and cognitive function', 'Delirium Rating Scale', 'health-related quality of life (HRQOL), functional status, and long-term neuropsychiatric outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",60.0,0.367689,"Treatment of suspected thiamine-related mental status changes with high dose intravenous (IV) thiamine has preliminary evidence for improving a variety of cognitive symptoms in oncology inpatient settings but has never been studied for the prevention of delirium in any population.
","[{'ForeName': 'Zev M', 'Initials': 'ZM', 'LastName': 'Nakamura', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. Electronic address: zev_nakamura@med.unc.edu.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Deal', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Rosenstein', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Quillen', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Chien', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Wood', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Shea', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Eliza M', 'Initials': 'EM', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106076']
1367,32619525,Modulation of startle and heart rate responses by fear of physical activity in patients with heart failure and in healthy adults.,"Fear of physical activity (FoPA) has been suggested as a barrier to physical activity in patients with heart failure and might be associated with low adherence to exercise regimen despite medical guideline recommendations. The present study examined physiological indicators of FoPA by assessing startle modulation (via EMG at the orbicularis oculi muscle) and heart rate responses (derived from ECG) after affective priming with lexical stimuli of positive, neutral, and negative valence, as well as words related to physical activity as potentially phobic cues. After screening for FoPA in patients with heart failure and healthy adults, twenty participants each were assigned to one of three subsamples: a healthy control group and two cardiac patient groups scoring either low or high on FoPA. The high-FoPA group showed startle potentiation and more pronounced heart rate acceleration (than did controls) in the phobic prime condition, indicating defensive response mobilization. Among the patients, higher FoPA accounted for 30% of the startle potentiation by phobic priming, whereas general anxiety, depression, and disease severity were no significant predictors of startle modulation. These findings suggest that FoPA in patients with heart failure is associated with defensive responses on a physiological level that might be indicative of avoidance behavior, thereby contributing to low adherence to exercise regimen. Thus, FoPA presents a significant target for psychological interventions to foster physical activity in cardiac patients.",2020,"Differences in FoPA accounted for 30% of the startle potentiation by phobic priming, whereas general anxiety, depression, and disease severity were no significant predictors in patients with heart failure.","['patients with heart failure', 'patients with heart failure and associated with lower physical activity despite medical exercise prescriptions', 'patients with heart failure and healthy adults, twenty participants each', 'Patients with Heart Failure and in Healthy Adults']","['Fear of physical activity (FoPA', 'FoPA', 'healthy control group and two cardiac patient groups scoring either low or high on FoPA']","['startle potentiation and heart rate acceleration (i.e., mobilization of defensive behavior', 'general anxiety, depression, and disease severity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0588464', 'cui_str': 'Exercise on prescription'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0086188', 'cui_str': 'Drug Potentiation'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",20.0,0.0134447,"Differences in FoPA accounted for 30% of the startle potentiation by phobic priming, whereas general anxiety, depression, and disease severity were no significant predictors in patients with heart failure.","[{'ForeName': 'Jeremia Mark', 'Initials': 'JM', 'LastName': 'Hoffmann', 'Affiliation': 'Division of Health Psychology, Department of Nursing Science, Trier University, Universitätsring 15, D-54286 Trier, Germany.'}, {'ForeName': 'Johannes B', 'Initials': 'JB', 'LastName': 'Finke', 'Affiliation': 'Department of Clinical Psychology, University of Siegen, Adolf-Reichwein-Straße 2a, D-57076 Siegen, Germany; Institute of Psychobiology, Department of Clinical Psychophysiology, Trier University, Johanniterufer 15, D-54290 Trier, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Schächinger', 'Affiliation': 'Institute of Psychobiology, Department of Clinical Psychophysiology, Trier University, Johanniterufer 15, D-54290 Trier, Germany.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Schulz', 'Affiliation': 'Institute for Health and Behaviour, Department of Behavioural and Cognitive Sciences, University of Luxembourg, 11, Porte des Sciences, L-4366 Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Vögele', 'Affiliation': 'Institute for Health and Behaviour, Department of Behavioural and Cognitive Sciences, University of Luxembourg, 11, Porte des Sciences, L-4366 Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Spaderna', 'Affiliation': 'Division of Health Psychology, Department of Nursing Science, Trier University, Universitätsring 15, D-54286 Trier, Germany. Electronic address: spaderna@uni-trier.de.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113044']
1368,32627052,The influence of different concentrations of flavanol chocolate bars under acute supplement conditions on exercise and performance.,"OBJECTIVE


The purpose of this study was to assess the effects and acute dosage of different flavanol concentrations in a dark chocolate bar on physiological parameters during steady state (SS) and incremental exercise.
METHODS


In a double-blind, randomised, crossover study, 15 healthy participants with a mean ± SD age of 30 ± 7 years; stature 176.8 ± 8.6 cm and body mass 80.3 ± 8.4 kg supplemented with high flavanol (HF) (1060 mg), moderate flavanol (MF) (746 mg), low flavanol (LF) (406 mg), or a control (CON) (88 mg) chocolate bar (~ 34 g), 2 h prior to 40 min of SS cycling (80% gas-exchange threshold) followed by an incremental test to volitional fatigue. During the SS cycle oxygen consumption ([Formula: see text]), respiratory exchange ratio (RER) and heart rate (HR) were continuously monitored. Plasma samples were collected prior to commencing exercise to determine nitrate (NO 3 - ) and nitrite (NO 2 - ) levels under each condition.
RESULTS


There was no observed effect between flavanol concentrations on [Formula: see text], RER, and HR during SS cycling (P > 0.05). [Formula: see text], peak power, HR peak, and RER peak also did not significantly differ between conditions (P > 0.05). There was a small trend for higher plasma NO 2 -  levels following higher flavanol concentration; however, this did not reach statistical significance (P > 0.05).
CONCLUSION


Acute supplementation with cocoa of differing flavanol concentrations does not appear to have any effect on exercise and performance. It is plausible that longer flavanol supplementation periods might have greater accumulative effects and thus may potentially elicit a larger effect.",2020,"There was no observed effect between flavanol concentrations on [Formula: see text], RER, and HR during SS cycling (P > 0.05).",['15 healthy participants with a mean\u2009±\u2009SD age of 30\u2009±\u20097\xa0years; stature 176.8\u2009±\u20098.6\xa0cm and body mass 80.3\u2009±\u20098.4\xa0kg supplemented with'],"['high flavanol (HF', 'moderate flavanol (MF) (746\xa0mg), low flavanol (LF) (406\xa0mg), or a control (CON) (88\xa0mg) chocolate bar (~\u200934\xa0g), 2\xa0h prior to 40\xa0min of SS cycling (80% gas-exchange threshold) followed by an incremental test to volitional fatigue', 'flavanol chocolate']","['peak power, HR peak, and RER peak', 'respiratory exchange ratio (RER) and heart rate (HR', 'flavanol concentrations on [Formula: see text], RER, and HR during SS cycling']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}]",15.0,0.127664,"There was no observed effect between flavanol concentrations on [Formula: see text], RER, and HR during SS cycling (P > 0.05).","[{'ForeName': 'Rishikesh K', 'Initials': 'RK', 'LastName': 'Patel', 'Affiliation': ""Faculty of Sport, Health and Applied Science, St Mary's University, London, UK. Rishi.patel@stmarys.ac.uk.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Brouner', 'Affiliation': 'School of Life Sciences, Kingston University, London, UK.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Allgrove', 'Affiliation': 'School of Life Sciences, Kingston University, London, UK.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Spendiff', 'Affiliation': 'School of Life Sciences, Kingston University, London, UK.'}]",European journal of applied physiology,['10.1007/s00421-020-04389-3']
1369,32628258,Advance Care Planning Video Intervention Among Long-Stay Nursing Home Residents: A Pragmatic Cluster Randomized Clinical Trial.,"Importance


Standardized, evidenced-based approaches to conducting advance care planning (ACP) in nursing homes are lacking.
Objective


To test the effect of an ACP video program on hospital transfers, burdensome treatments, and hospice enrollment among long-stay nursing home residents with and without advanced illness.
Design, Setting, and Participants


The Pragmatic Trial of Video Education in Nursing Homes was a pragmatic cluster randomized clinical trial conducted between February 1, 2016, and May 31, 2019, at 360 nursing homes (119 intervention and 241 control) in 32 states owned by 2 for-profit corporations. Participants included 4171 long-stay residents with advanced dementia or cardiopulmonary disease (hereafter referred to as advanced illness) in the intervention group and 8308 long-stay residents with advanced illness in the control group, 5764 long-stay residents without advanced illness in the intervention group, and 11 773 long-stay residents without advanced illness in the control group. Analyses followed the intention-to-treat principle.
Interventions


Five 6- to 10-minute ACP videos were made available on tablet computers or online. Designated champions (mostly social workers) in intervention facilities were instructed to offer residents (or their proxies) the opportunity to view a video(s) on admission and every 6 months. Control facilities used usual ACP practices.
Main Outcomes and Measures


Twelve-month outcomes were measured for each resident. The primary outcome was hospital transfers per 1000 person-days alive in the advanced illness cohort. Secondary outcomes included the proportion of residents with or without advanced illness experiencing 1 or more hospital transfer, 1 or more burdensome treatment, and hospice enrollment. To monitor fidelity, champions completed reports in the electronic record whenever they offered to show residents a video.
Results


The study included 4171 long-stay residents with advanced illness in the intervention group (2970 women [71.2%]; mean [SD] age, 83.6 [9.1] years), and 8308 long-stay residents with advanced illness in the control group (5857 women [70.5%]; mean [SD] age, 83.6 [8.9] years), 5764 long-stay residents without advanced illness in the intervention group (3692 women [64.1%]; mean [SD] age, 81.5 [9.2] years), and 11 773 long-stay residents without advanced illness in the control group (7467 women [63.4%]; mean [SD] age, 81.3 [9.2] years). There was no significant reduction in hospital transfers per 1000 person-days alive in the intervention vs control groups (rate [SE], 3.7 [0.2]; 95% CI, 3.4-4.0 vs 3.9 [0.3]; 95% CI, 3.6-4.1; rate difference [SE], -0.2 [0.3]; 95% CI, -0.5 to 0.2). Secondary outcomes did not significantly differ between trial groups among residents with and without advanced illness. Based on champions' reports, 912 of 4171 residents with advanced illness (21.9%) viewed ACP videos. Facility-level rates of showing ACP videos ranged from 0% (14 of 119 facilities [11.8%]) to more than 40% (22 facilities [18.5%]).
Conclusions and Relevance


This study found that an ACP video program was not effective in reducing hospital transfers, decreasing burdensome treatment use, or increasing hospice enrollment among long-stay residents with or without advanced illness. Intervention fidelity was low, highlighting the challenges of implementing new programs in nursing homes.
Trial Registration


ClinicalTrials.gov Identifier: NCT02612688.",2020,"This study found that an ACP video program was not effective in reducing hospital transfers, decreasing burdensome treatment use, or increasing hospice enrollment among long-stay residents with or without advanced illness.","['Nursing Homes was a pragmatic cluster randomized clinical trial conducted between February 1, 2016, and May 31, 2019, at 360 nursing homes (119 intervention and 241 control) in 32 states owned by 2 for-profit corporations', 'Long-Stay Nursing Home Residents', '4171 residents with advanced illness (21.9%) viewed ACP videos', '4171 long-stay residents with advanced illness in the intervention group (2970 women [71.2%]; mean [SD] age, 83.6 [9.1] years), and 8308 long-stay residents with advanced illness in the control group (5857 women [70.5%]; mean [SD] age, 83.6 [8.9] years), 5764 long-stay residents without advanced illness in the intervention group (3692 women [64.1%]; mean [SD] age, 81.5 [9.2] years), and 11\u202f773 long-stay residents without advanced illness in the control group (7467 women [63.4%]; mean [SD] age, 81.3 [9.2] years', 'Participants included 4171 long-stay residents with advanced dementia or cardiopulmonary disease (hereafter referred to as advanced illness) in the intervention group and 8308 long-stay residents with advanced illness in the control group, 5764 long-stay residents without advanced illness in the intervention group, and 11\u202f773 long-stay residents without advanced illness in the control group', 'long-stay residents with or without advanced illness', 'long-stay nursing home residents with and without advanced illness']","['advance care planning (ACP', 'Video Education', 'Advance Care Planning Video Intervention', 'ACP video program']","['proportion of residents with or without advanced illness experiencing 1 or more hospital transfer, 1 or more burdensome treatment, and hospice enrollment', 'hospital transfers, burdensome treatments, and hospice enrollment', 'hospital transfers', 'hospital transfers per 1000 person-days alive in the advanced illness cohort', 'Facility-level rates of showing ACP videos']","[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0034072', 'cui_str': 'Cor pulmonale'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0042655', 'cui_str': 'Video'}]",4171.0,0.160497,"This study found that an ACP video program was not effective in reducing hospital transfers, decreasing burdensome treatment use, or increasing hospice enrollment among long-stay residents with or without advanced illness.","[{'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Mitchell', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, Massachusetts.'}, {'ForeName': 'Angelo E', 'Initials': 'AE', 'LastName': 'Volandes', 'Affiliation': 'Section of General Medicine, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Roee', 'Initials': 'R', 'LastName': 'Gutman', 'Affiliation': 'Department of Biostatistics, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Gozalo', 'Affiliation': 'Center for Gerontology and Healthcare Research, Department of Health Services, Policy, and Practice, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Ogarek', 'Affiliation': 'Center for Gerontology and Healthcare Research, Department of Health Services, Policy, and Practice, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Lacey', 'Initials': 'L', 'LastName': 'Loomer', 'Affiliation': 'Center for Gerontology and Healthcare Research, Department of Health Services, Policy, and Practice, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'McCreedy', 'Affiliation': 'Center for Gerontology and Healthcare Research, Department of Health Services, Policy, and Practice, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Ruoshui', 'Initials': 'R', 'LastName': 'Zhai', 'Affiliation': 'Center for Gerontology and Healthcare Research, Department of Health Services, Policy, and Practice, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Mor', 'Affiliation': 'Center for Gerontology and Healthcare Research, Department of Health Services, Policy, and Practice, Brown University School of Public Health, Providence, Rhode Island.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.2366']
1370,32623182,"Gemcitabine plus nab-paclitaxel until progression or alternating with FOLFIRI.3, as first-line treatment for patients with metastatic pancreatic adenocarcinoma: The Federation Francophone de Cancérologie Digestive-PRODIGE 37 randomised phase II study (FIRGEMAX).","BACKGROUND


Chemotherapy is effective in metastatic pancreatic adenocarcinoma (mPA), but new approaches are still needed to improve patients' survival and quality of life. We have previously published good efficacy and tolerability results on a sequential treatment strategy of gemcitabine followed by an intensified FOLFIRI (5FU+irinotecan) regimen. In the present study, we evaluated the same sequence but replaced gemcitabine by the new gemcitabine + nab-paclitaxel standard first-line combination.
PATIENTS AND METHODS


We randomised chemotherapy-naive patients with proven mPA, bilirubin levels ≤1.5 upper limit of normal values and performance status 0-2 to alternately receive gemcitabine + nab-paclitaxel for 2 months then FOLFIRI.3 for 2 months in arm A, or gemcitabine + nab-paclitaxel alone until progression in arm B. The primary objective was to increase the 6-month progression-free survival (PFS) rate from 40% (H 0 ) to 60% (H 1 ); using the binomial exact method, 124 patients were required. Analyses were carried out in preplanned modified intention-to-treat (mITT) and per-protocol (PP) populations.
RESULTS


Between November 2015 and November 2016, 127 patients were enrolled. Main grade III-IV toxicities (% in arm A/B) were: diarrhoea (12.5/1.7), neutropenia (46.9/31, including febrile neutropenia: 1.6/0), skin toxicity (6.3/13.8), and peripheral neuropathy (6.3/8.6). No toxic deaths occurred. The objective response rate was 40.3% (95% confidence interval [CI]: 28.1-53.6) in arm A and 26.7% (95% CI: 16.1-39.7) in arm B. The primary end-point (6-month PFS rate) was 45.2% [one-sided 95% CI: 34.3-56.4] in arm A and 23.3% in arm B [one-sided 95% CI: 14.3-32.3] in the mITT population. In the PP population, median PFS and OS were 7.6 months and 6 months and 14.5 months and 12.2 months in arm A and B, respectively.
CONCLUSIONS


The FIRGEMAX strategy with gemcitabine + nab-paclitaxel alternating with FOLFIRI.3 every 2 months, appears feasible and effective, with manageable toxicities, in patients able to reach >2mo of treatment.
TRIAL REGISTRATION INFORMATION


EudraCT: 2014-004449-28: NCT: 0282701.",2020,The objective response rate was 40.3% (95% confidence interval [CI]: 28.1-53.6) in arm A and 26.7% (95% CI: 16.1-39.7) in arm,"['We randomised chemotherapy-naive patients with proven mPA, bilirubin levels ≤1.5 upper limit of normal values and performance status\xa00-2 to alternately receive', 'metastatic pancreatic adenocarcinoma (mPA', 'patients with metastatic pancreatic adenocarcinoma', 'Between November 2015 and November 2016', '127 patients were enrolled']","['gemcitabine\xa0+\xa0nab-paclitaxel', 'Gemcitabine plus nab-paclitaxel until progression or alternating with FOLFIRI.3', 'gemcitabine\xa0+\xa0nab-paclitaxel standard first-line combination', 'gemcitabine\xa0+\xa0nab-paclitaxel alone until progression in arm B', 'gemcitabine', 'gemcitabine\xa0+\xa0nab-paclitaxel alternating with FOLFIRI.3']","['peripheral neuropathy', 'toxic deaths', 'neutropenia', 'diarrhoea', 'Main grade III-IV toxicities', 'median PFS and OS', 'skin toxicity', 'objective response rate', '6-month progression-free survival (PFS) rate']","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0861727', 'cui_str': 'Pancreatic adenocarcinoma metastatic'}, {'cui': 'C0344395', 'cui_str': 'Bilirubin measurement'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0086715', 'cui_str': 'Normal range'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",127.0,0.0595149,The objective response rate was 40.3% (95% confidence interval [CI]: 28.1-53.6) in arm A and 26.7% (95% CI: 16.1-39.7) in arm,"[{'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rinaldi', 'Affiliation': 'Department of Hepato-gastroenterology, European Hospital, Marseille, France.'}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Pointet', 'Affiliation': 'Department of Hepato-gastroenterology, Georges Pompidou European Hospital, Paris, France.'}, {'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Khemissa Akouz', 'Affiliation': 'Department of Hepato-gastroenterology, Saint Jean Hospital, Perpignan, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Le Malicot', 'Affiliation': 'Biostatistics Department, Francophone Federation of Digestive Cancerology, EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, Dijon, France.'}, {'ForeName': 'Bidaut', 'Initials': 'B', 'LastName': 'Wahiba', 'Affiliation': 'Department of Hepato-gastroenterology, European Hospital, Marseille, France.'}, {'ForeName': 'Samy', 'Initials': 'S', 'LastName': 'Louafi', 'Affiliation': 'Department of Oncology, Sud Francilien Hospital Center, Corbeil-Essonnes, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Gratet', 'Affiliation': 'Oncology and Hematology ONCOSUD Unit, Clinic Pasteur, Toulouse, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Miglianico', 'Affiliation': 'Department of Radiotherapy, Private Hospital Center, Saint-Grégoire, France.'}, {'ForeName': 'Hortense', 'Initials': 'H', 'LastName': 'Laharie', 'Affiliation': 'Department of Oncology and Radiotherapy, Clinic Tivoli, Bordeaux, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Bouhier Leporrier', 'Affiliation': 'Department of Hepato-gastroenterology, University Hospital, Caen, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Thirot Bidault', 'Affiliation': 'Department of Hepato-gastroenterology, Private Hospital, Antony, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Texereau', 'Affiliation': 'Department of Hepato-gastroenterology, Layne Hospital, Mont-De-Marsan, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Coriat', 'Affiliation': 'Department of Hepato-gastroenterology, Cochin Hospital, APHP, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Terrebonne', 'Affiliation': 'Department of Hepato-gastroenterology, Haut Lévêque Hospital, Pessac, France.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Gouttebel', 'Affiliation': 'Department of Oncology, Drôme Nord Hospital, Romans Sur Isère, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Malka', 'Affiliation': 'Department of Hepato-gastroenterology, Gustave Roussy Cancer Campus, Villejuif, France.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Bachet', 'Affiliation': 'Department of Hepato-gastroenterology, Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Côme', 'Initials': 'C', 'LastName': 'Lepage', 'Affiliation': 'Department of Hepato-gastroenterology, University Hospital of Dijon, EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, Dijon, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Taieb', 'Affiliation': 'Department of Hepato-gastroenterology, Sorbonne Paris City, Paris Descartes University, Georges Pompidou European Hospital, Paris, France. Electronic address: jtaieb75@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.05.018']
1371,32633861,Anti-vascular endothelial growth factor for macular oedema secondary to branch retinal vein occlusion.,"BACKGROUND


Branch retinal vein occlusion (BRVO) is one of the most commonly occurring retinal vascular abnormalities. The most common cause of visual loss in people with BRVO is macular oedema (MO). Grid or focal laser photocoagulation has been shown to reduce the risk of visual loss. Limitations to this treatment exist, however, and newer modalities may have equal or improved efficacy. Antiangiogenic therapy with anti-vascular endothelial growth factor (anti-VEGF) has recently been used successfully to treat MO resulting from a variety of causes.
OBJECTIVES


To investigate the efficacy and gather evidence from randomised controlled trials (RCTs) on the potential harms of anti-vascular endothelial growth factor (VEGF) agents for the treatment of macular oedema (MO) secondary to branch retinal vein occlusion (BRVO).
SEARCH METHODS


We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2019, Issue 6); MEDLINE Ovid; Embase Ovid; the ISRCTN registry; ClinicalTrials.gov; and the WHO ICTRP. The date of the last search was 12 June 2019.
SELECTION CRITERIA


We included randomised controlled trials (RCTs) investigating BRVO. Eligible trials had to have at least six months' follow-up where anti-VEGF treatment was compared with another treatment, no treatment, or placebo. We excluded trials where combination treatments (anti-VEGF plus other treatments) were used; and trials that investigated the dose and duration of treatment without a comparison group (other treatment/no treatment/sham).
DATA COLLECTION AND ANALYSIS


Two review authors independently extracted the data using standard methodological procedures expected by Cochrane. The primary outcome was the proportion of participants with an improvement from baseline in best-corrected visual acuity of greater than or equal to 15 letters (3 lines) on the Early Treatment in Diabetic Retinopathy Study (ETDRS) Chart at six months and 12 months of follow-up. The secondary outcomes were the proportion of participants who lost greater than or equal to 15 ETDRS letters (3 lines) and the mean visual acuity (VA) change at six and 12 months, as well as the change in central retinal thickness (CRT) on optical coherence tomography from baseline at six and 12 months. We also collected data on adverse events and quality of life (QoL).
MAIN RESULTS


We found eight RCTs of 1631 participants that met the inclusion criteria after independent and duplicate review of the search results. These studies took place in Europe, North America, Eastern Mediterranean region and East Asia. Included participants were adults aged 18 or over with VA of 20/40 or worse. Studies varied by duration of disease but permitted previously treated eyes as long as there was sufficient treatment-free interval. All anti-VEGF agents (bevacizumab, ranibizumab and aflibercept) and steroids (triamcinolone and dexamethasone) were included. Overall, we judged the studies to be at moderate or unclear risk of bias. Four of the eight studies did not mask participants or outcome assessors, or both. One trial compared anti-VEGF to sham. At six months, eyes receiving anti-VEGF were significantly more likely to have a gain of 15 or more ETDRS letters (risk ratio (RR) 1.72, 95% confidence interval (CI) 1.19 to 2.49; 283 participants; moderate-certainty evidence). Mean VA was better in the anti-VEGF group at six months compared with control (mean difference (MD) 7.50 letters, 95% CI 5.29 to 9.71; 282 participants; moderate-certainty evidence). Anti-VEGF also proved more effective at reducing CRT at six months (MD -57.50 microns, 95% CI -108.63 to -6.37; 281 participants; lower CRT is better; moderate-certainty evidence). There was only very low-certainty evidence on adverse effects. There were no reports of endophthalmitis. Mean change in QoL (measured using the National Eye Institute Visual Functioning Questionnaire VFQ-25) was better in people treated with anti-VEGF compared with people treated with sham (MD 7.6 higher score, 95% CI 4.3 to 10.9; 281 participants; moderate-certainty evidence). Three RCTs compared anti-VEGF with macular laser (total participants = 473). The proportion of eyes gaining 15 or more letters was greater in the anti-VEGF group at six months (RR 2.09, 95% CI 1.44 to 3.05; 2 studies, 201 participants; moderate-certainty evidence). Mean VA in the anti-VEGF groups was better than the laser groups at six months (MD 9.63 letters, 95% CI 7.23 to 12.03; 3 studies, 473 participants; moderate-certainty evidence). There was a greater reduction in CRT in the anti-VEGF group compared with the laser group at six months (MD -147.47 microns, 95% CI -200.19 to -94.75; 2 studies, 201 participants; moderate-certainty evidence). There was only very low-certainty evidence on adverse events. There were no reports of endophthalmitis. QoL outcomes were not reported. Four studies compared anti-VEGF with intravitreal steroid (875 participants). The proportion of eyes gaining 15 or more ETDRS letters was greater in the anti-VEGF group at six months (RR 1.67, 95% CI 1.33 to 2.10; 2 studies, 330 participants; high-certainty evidence) and 12 months (RR 1.76, 95% CI 1.36 to 2.28; 1 study, 307 participants; high-certainty evidence). Mean VA was better in the anti-VEGF group at six months (MD 8.22 letters, 95% CI 5.69 to 10.76; 2 studies, 330 participants; high-certainty evidence) and 12 months (MD 9.15 letters, 95% CI 6.32 to 11.97; 2 studies, 343 participants; high-certainty evidence). Mean CRT also showed a greater reduction in the anti-VEGF arm at 12 months compared with intravitreal steroid (MD -26.92 microns, 95% CI -65.88 to 12.04; 2 studies, 343 participants; moderate-certainty evidence). People receiving anti-VEGF showed a greater improvement in QoL at 12 months compared to those receiving steroid (MD 3.10, 95% CI 0.22 to 5.98; 1 study, 307 participants; moderate-certainty evidence). Moderate-certainty evidence suggested increased risk of cataract and raised IOP with steroids. There was only very low-certainty evidence on APTC events. No cases of endophthalmitis were observed.
AUTHORS' CONCLUSIONS


The available RCT evidence suggests that treatment of MO secondary to BRVO with anti-VEGF improves visual and anatomical outcomes at six and 12 months.",2020,"Mean VA was better in the anti-VEGF group at six months (MD 8.22 letters, 95% CI 5.69 to 10.76; 2 studies, 330 participants; high-certainty evidence) and 12 months (MD 9.15 letters, 95% CI 6.32 to 11.97; 2 studies, 343 participants; high-certainty evidence).","['macular oedema (MO) secondary to branch retinal vein occlusion (BRVO', '1631 participants that met the inclusion criteria after independent and duplicate review of the search results', 'Included participants were adults aged 18 or over with VA of 20/40 or worse', 'Europe, North America, Eastern Mediterranean region and East Asia', 'macular oedema secondary to branch retinal vein occlusion', 'people with BRVO is macular oedema (MO']","['comparison group (other treatment/no treatment/sham', 'anti-VEGF with intravitreal steroid', 'Antiangiogenic therapy with anti-vascular endothelial growth factor (anti-VEGF', 'placebo', 'anti-VEGF', 'Branch retinal vein occlusion (BRVO', 'VEGF agents (bevacizumab, ranibizumab and aflibercept) and steroids (triamcinolone and dexamethasone', 'Grid or focal laser photocoagulation', 'anti-vascular endothelial growth factor (VEGF) agents', 'Anti-vascular endothelial growth factor']","['CRT', 'visual and anatomical outcomes', 'gain of 15 or more ETDRS letters', 'visual loss', 'endophthalmitis', 'central retinal thickness (CRT', 'Diabetic Retinopathy Study (ETDRS', 'risk of visual loss', 'adverse events', 'adverse events and quality of life (QoL', 'QoL', 'proportion of eyes gaining 15 or more ETDRS letters', 'QoL outcomes', 'proportion of participants with an improvement from baseline in best-corrected visual acuity', 'proportion of eyes gaining 15 or more letters', 'Mean VA', 'Mean CRT', 'proportion of participants who lost greater than or equal to 15 ETDRS letters (3 lines) and the mean visual acuity (VA) change', 'National Eye Institute Visual Functioning Questionnaire VFQ-25', 'adverse effects', 'Mean change in QoL']","[{'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0339505', 'cui_str': 'Venous retinal branch occlusion'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0699752', 'cui_str': 'Review of'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0442752', 'cui_str': 'Distance vision 6/12'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0282645', 'cui_str': 'Mediterranean Region'}, {'cui': 'C0015631', 'cui_str': 'Far east country'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C2363719', 'cui_str': 'Antiangiogenic therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0339505', 'cui_str': 'Venous retinal branch occlusion'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0948675', 'cui_str': 'Focal laser photocoagulation'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}, {'cui': 'C0014236', 'cui_str': 'Endophthalmitis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1955969', 'cui_str': 'National Eye Institute'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",307.0,0.421011,"Mean VA was better in the anti-VEGF group at six months (MD 8.22 letters, 95% CI 5.69 to 10.76; 2 studies, 330 participants; high-certainty evidence) and 12 months (MD 9.15 letters, 95% CI 6.32 to 11.97; 2 studies, 343 participants; high-certainty evidence).","[{'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Shalchi', 'Affiliation': 'Moorfields Eye Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Mahroo', 'Affiliation': 'Moorfields Eye Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Catey', 'Initials': 'C', 'LastName': 'Bunce', 'Affiliation': 'London, UK.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Mitry', 'Affiliation': 'Moorfields Eye Hospital NHS Foundation Trust, London, UK.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD009510.pub3']
1372,32633901,Time course of pupillary response to threat words before and after attention bias modification for transdiagnostic anxiety disorders: A randomized controlled trial.,"INTRODUCTION


Altered attention to threatening stimuli at initial and sustained stages of processing may be dissociable dimensions that influence the development and maintenance of transdiagnostic symptoms of anxiety, such as vigilance, and possibly require distinct intervention. Attention bias modification (ABM) interventions were created to implicitly train attention away from threatening stimuli and have shown efficacy in treating anxiety. ABM alters neurocognitive functioning during initial stages of threat processing, but less is known regarding effects of ABM on neural indices of threat processing at sustained (i.e., intermediate and late) stages, or if ABM-related neural changes relate to symptom response. The current study utilized pupillary response as a temporally sensitive and cost-effective peripheral marker of neurocognitive response to ABM.
MATERIALS AND METHODS


In a randomized controlled trial, 79 patients with transdiagnostic anxiety provided baseline data, 70 were randomized to receive eight sessions of twice-weekly ABM (n = 49) or sham training (n = 21), and 65 completed their assigned treatment condition and returned for post-training assessment.
RESULTS


Among ABM, but not sham, patients, pupillary response to threat words during initial and intermediate stages decreased from pre- to post-training. Pre- to post-training reductions in intermediate and late pupillary response to threat were positively correlated with reductions in patient-reported vigilance among ABM, but not sham, patients.
CONCLUSIONS


All measured stages of threat processing had relevance in understanding the neural mechanisms of ABM, with overlapping yet dissociable roles exhibited within a single neurophysiological marker across an initial-intermediate-late time continuum. Pupillometry may be well suited to measure both target engagement and treatment outcome following ABM.",2020,"Pre- to post-training reductions in intermediate and late pupillary response to threat were positively correlated with reductions in patient-reported vigilance among ABM, but not sham, patients.
","['79 patients with transdiagnostic anxiety provided baseline data, 70', 'transdiagnostic anxiety disorders']","['ABM', 'twice-weekly ABM (n\xa0=\xa049) or sham training']",['pupillary response to threat words during initial and intermediate stages'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",79.0,0.0719312,"Pre- to post-training reductions in intermediate and late pupillary response to threat were positively correlated with reductions in patient-reported vigilance among ABM, but not sham, patients.
","[{'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Woody', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Vaughn-Coaxum', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Greg J', 'Initials': 'GJ', 'LastName': 'Siegle', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Rebecca B', 'Initials': 'RB', 'LastName': 'Price', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Brain and behavior,['10.1002/brb3.1664']
1373,32633899,Corticomotor reorganization during short-term visuomotor training in the lower back: A randomized controlled study.,"INTRODUCTION


Accumulating evidence suggests that motor skill training is associated with structural and functional reorganization of the primary motor cortex. However, previous studies have focussed primarily upon the upper limb, and it is unclear whether comparable reorganization occurs following training of other regions, such as the lower back. Although this holds important implications for rehabilitation, no studies have examined corticomotor adaptations following short-term motor training in the lower back.
METHOD


The aims of this study were to (a) determine whether a short-term lumbopelvic tilt visuomotor task induced reorganization of the corticomotor representations of lower back muscles, (b) quantify the variability of corticomotor responses to motor training, and (c) determine whether any improvements in task performance were correlated with corticomotor reorganization. Participants were allocated randomly to perform a lumbopelvic tilt motor training task (n = 15) or a finger abduction control task involving no lumbopelvic movement (n = 15). Transcranial magnetic stimulation was used to map corticomotor representations of the lumbar erector spinae before, during, and after repeated performance of the allocated task.
RESULTS


No relationship between corticomotor reorganization and improved task performance was identified. Substantial variability was observed in terms of corticomotor responses to motor training, with approximately 50% of participants showing no corticomotor reorganization despite significant improvements in task performance.
CONCLUSION


These findings suggest that short-term improvements in lower back visuomotor task performance may be driven by changes in remote subcortical and/or spinal networks rather than adaptations in corticomotor pathways. However, further research using tasks of varying complexities and durations is required to confirm this hypothesis.",2020,No relationship between corticomotor reorganization and improved task performance was identified.,[],"['motor skill training', 'Corticomotor reorganization during short-term visuomotor training', 'Transcranial magnetic stimulation', 'lumbopelvic tilt motor training task (n\xa0=\xa015) or a finger abduction control task involving no lumbopelvic movement']","['task performance', 'lower back visuomotor task performance']",[],"[{'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]","[{'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",,0.0295293,No relationship between corticomotor reorganization and improved task performance was identified.,"[{'ForeName': 'Rocco', 'Initials': 'R', 'LastName': 'Cavaleri', 'Affiliation': 'School of Health Sciences, Western Sydney University, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Lucy S', 'Initials': 'LS', 'LastName': 'Chipchase', 'Affiliation': 'School of Health Sciences, Western Sydney University, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Massé-Alarie', 'Affiliation': 'CIRRIS Research Centre, Department of Rehabilitation, Laval University, Quebec, Canada.'}, {'ForeName': 'Siobhan M', 'Initials': 'SM', 'LastName': 'Schabrun', 'Affiliation': 'Neuroscience Research Australia, Randwick, New South Wales, Australia.'}, {'ForeName': 'Muath A', 'Initials': 'MA', 'LastName': 'Shraim', 'Affiliation': 'Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Hodges', 'Affiliation': 'Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}]",Brain and behavior,['10.1002/brb3.1702']
1374,32648464,Management and experience of postural placement in postoperative mechanical ventilation of newborns.,"BACKGROUND


Congenital diaphragmatic hernia (CDH) is a neonatal condition that mainly occurs when the abdominal organs herniate into the thorax, obstructing the development of the lungs. Postoperative neonatal breathing disorder is one of the main causes of neonatal death. This study summarizes the postoperative nursing status of 30 cases of neonatal CDH in our hospital, and explores the effect of body position in mechanical ventilation care following CDH surgery.
METHODS


A total of 30 CHD children admitted in our hospital between June, 2018 and October, 2019 were included. The neonates were divided into preterm infant group (n=15) and full-term infant group (n=15). Each child was immediately transferred to the newborn intensive care unit (NICU) ward after surgery and received the hospital's NCIU special care. Besides routine nursing, each child was placed in a randomly selected primary position (the prone position or supine position). After 30 min, their oxygenation indexes were measured, and then their position (prone position or supine position) was changed. After 30 min, the neonates' oxygenation indicators were measured again. A hospital-made satisfaction questionnaire was used to evaluate the parents' satisfaction with nursing care.
RESULTS


Two children died of respiratory failure (one in the preterm group and one in the full-term group), and the rest were in a stable condition after surgery. There was no significant difference between the rates of parent satisfaction in the two groups (preterm infant group: 96.67% verse full-term group: 93.33%, P>0.05). In both groups, the partial pressure of oxygen in arterial blood (PaO2), partial pressure of oxygen in arterial blood/fraction of inspiration O2 (PaO2/FiO2), and partial pressure of oxygen in arterial blood/partial pressure of oxygen in the alveolar gas (PaO2/PAO2) in prone position were significantly higher than those in supine position (P<0.05); the alveolar-arterial oxygen difference (A-aDO2) was significantly lower than that in the supine position (0.05).
CONCLUSIONS


The prone position can improve the oxygenation index of children after surgery, and improve their respiratory system function. This method is suitable for newborn postoperative NICU care.",2020,"There was no significant difference between the rates of parent satisfaction in the two groups (preterm infant group: 96.67% verse full-term group: 93.33%, P>0.05).","['30 CHD children admitted in our hospital between June, 2018 and October, 2019 were included', 'postoperative mechanical ventilation of newborns', 'Congenital diaphragmatic hernia (CDH']","['postural placement', ""newborn intensive care unit (NICU) ward after surgery and received the hospital's NCIU special care""]","['respiratory failure', 'alveolar-arterial oxygen difference (A-aDO2', 'rates of parent satisfaction', 'partial pressure of oxygen in arterial blood (PaO2), partial pressure of oxygen in arterial blood/fraction of inspiration O2 (PaO2/FiO2), and partial pressure of oxygen in arterial blood/partial pressure of oxygen in the alveolar gas (PaO2/PAO2) in prone position']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0235833', 'cui_str': 'Congenital diaphragmatic hernia'}]","[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205555', 'cui_str': 'Special'}]","[{'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1822073', 'cui_str': 'PaO2'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}]",30.0,0.0439864,"There was no significant difference between the rates of parent satisfaction in the two groups (preterm infant group: 96.67% verse full-term group: 93.33%, P>0.05).","[{'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': ""Department of Outpatient, Huai'an Maternal and Child Health Care Center, Huai'an, China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Neonatology, Huai'an Maternal and Child Health Care Center, Huai'an, China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Outpatient, Huai'an Maternal and Child Health Care Center, Huai'an, China.""}, {'ForeName': 'Yongfeng', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': ""Department of Sterilization Supply Room, Huai'an Maternal and Child Health Care Center, Huai'an, China. zya0626@163.com.""}]",Annals of palliative medicine,['10.21037/apm-20-1003']
1375,32645968,Feasibility Randomized Trial for an Intensive Memory-Focused Training Program for School-Aged Children with Acquired Brain Injury.,"(1) Background: Memory deficits are common sequelae of pediatric Acquired Brain Injury (ABI). Only methods for non-focused cognitive remediation are available to the pediatric field. The aims of this feasibility trial are the description, implementation, and test of an intensive program specific to the training and re-adaptation of memory function in children, called Intensive Memory-Focused Training Program (IM-FTP); (2) Methods: Eleven children and adolescents with ABI (mean age at injury = 12.2 years, brain tumor survivors excluded) were clinically assessed and rehabilitated over 1-month through IM-FTP, including physio-kinesis/occupational, speech, and neuropsychology treatments. Each patient received a psychometric evaluation and a brain functional MRI at enrollment and at discharge. Ten pediatric controls with ABI (mean age at injury = 13.8 years) were clinically assessed, and rehabilitated through a standard program; (3) Results: After treatment, both groups had marked improvement in both immediate and delayed recall. IM-FTP was associated with better learning of semantically related and unrelated words, and larger improvement in immediate recall in prose memory. Imaging showed functional modification in the left frontal inferior cortex; (4) Conclusions: We described an age-independent reproducible multidisciplinary memory-focused rehabilitation protocol, which can be adapted to single patients while preserving inter-subject comparability, and is applicable up to a few months after injury. IM-FTP will now be employed in a powered clinical trial.",2020,"IM-FTP was associated with better learning of semantically related and unrelated words, and larger improvement in immediate recall in prose memory.","['School-Aged Children with Acquired Brain Injury', 'Ten pediatric controls with ABI (mean age at injury = 13.8 years) were clinically assessed, and rehabilitated through a standard program; (3) Results', 'pediatric Acquired Brain Injury (ABI', 'children, called Intensive Memory-Focused Training Program (IM-FTP); (2) Methods: Eleven children and adolescents with ABI (mean age at injury = 12.2 years, brain tumor survivors excluded) were clinically assessed and rehabilitated over 1-month through IM-FTP, including physio-kinesis/occupational, speech, and neuropsychology treatments']","['IM-FTP', 'Intensive Memory-Focused Training Program']",['immediate and delayed recall'],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022699', 'cui_str': 'Kinesis'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0027903', 'cui_str': 'Neuropsychology'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",11.0,0.0850281,"IM-FTP was associated with better learning of semantically related and unrelated words, and larger improvement in immediate recall in prose memory.","[{'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Recla', 'Affiliation': 'Neurophysiatric Department, Neuropsychological and Cognitive-behavioral Service, Scientific Institute, I.R.C.C.S. Eugenio Medea, 23842 Bosisio Parini, Italy.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Molteni', 'Affiliation': ""School of Biomedical Engineering & Imaging Sciences, and Centre for Medical Engineering, King's College, SE1 7EU London, UK.""}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Manfredi', 'Affiliation': 'Neurophysiatric Department, Neuropsychological and Cognitive-behavioral Service, Scientific Institute, I.R.C.C.S. Eugenio Medea, 23842 Bosisio Parini, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Arrigoni', 'Affiliation': 'Neuroimaging Lab, Scientific Institute, I.R.C.C.S. Eugenio Medea, 23842 Bosisio Parini, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Nordio', 'Affiliation': 'Neuroimaging Lab, Scientific Institute, I.R.C.C.S. Eugenio Medea, 23842 Bosisio Parini, Italy.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Galbiati', 'Affiliation': 'Neurophysiatric Department, Neuropsychological and Cognitive-behavioral Service, Scientific Institute, I.R.C.C.S. Eugenio Medea, 23842 Bosisio Parini, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Pastore', 'Affiliation': 'Neurophysiatric Department, Neuropsychological and Cognitive-behavioral Service, Scientific Institute, I.R.C.C.S. Eugenio Medea, 23842 Bosisio Parini, Italy.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Modat', 'Affiliation': ""School of Biomedical Engineering & Imaging Sciences, and Centre for Medical Engineering, King's College, SE1 7EU London, UK.""}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Strazzer', 'Affiliation': 'Neurophysiatric Department, Scientific Institute, I.R.C.C.S. Eugenio Medea, 23842 Bosisio Parini, Italy.'}]",Brain sciences,['10.3390/brainsci10070430']
1376,32651046,Corrigendum to 'Dynamic risk assessment based on positron emission tomography scanning in diffuse large B-cell lymphoma: Post-hoc analysis from the PETAL trial' [Eur J Canc 124 (January 2020) 25-36].,,2020,,['diffuse large B-cell lymphoma'],"[""Corrigendum to 'Dynamic risk assessment based on positron emission tomography scanning""]",[],"[{'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]",[],,0.0252584,,"[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Schmitz', 'Affiliation': 'Department of Hematology, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany. Electronic address: christine.schmitz@uk-essen.de.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hüttmann', 'Affiliation': 'Department of Hematology, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Stefan P', 'Initials': 'SP', 'LastName': 'Müller', 'Affiliation': 'Department of Nuclear Medicine, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Maher', 'Initials': 'M', 'LastName': 'Hanoun', 'Affiliation': 'Department of Hematology, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Boellaard', 'Affiliation': 'Department of Radiology and Nuclear Medicine, VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Brinkmann', 'Affiliation': 'Center for Clinical Trials, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Karl-Heinz', 'Initials': 'KH', 'LastName': 'Jöckel', 'Affiliation': 'Institute for Medical Informatics, Biometry and Epidemiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Dührsen', 'Affiliation': 'Department of Hematology, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Rekowski', 'Affiliation': 'Institute for Medical Informatics, Biometry and Epidemiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.05.019']
1377,32651047,Do peer social relationships mediate the harmful effects of a housing mobility experiment on boys' risky behaviors?,"PURPOSE


The purpose of this study was to understand why a housing mobility experiment caused harmful effects on adolescent boys' risky behaviors.
METHODS


Moving to Opportunity (MTO) (1994-2010) randomly assigned volunteer families to a treatment group receiving a Section 8 rental voucher or a public housing control group. Our outcome was a global risky behavior index (RBI; measured in 2002, n = 750 boys) measuring the fraction of 10 items the youth engaged in, 6 measuring past 30-day substance use and 4 measuring recent risky sexual behavior. Potential mediators (measured in 2002) included peer social relationships (e.g., peer drug use, peer gang membership).
RESULTS


The voucher treatment main effect on boys' RBI was harmful (B (SE) = 0.05 (0.02), 95% CI 0.01, 0.08), and treatment marginally increased having friends who used drugs compared to controls (B (SE) = 0.67 (0.23), 95% CI 0.22, 1.12). Having friends who used drugs marginally mediated the MTO treatment effect on RBI (indirect effect: B (SE) = 0.02(.01), 95% CI -0.002, 0.04), reducing the total treatment effect by 39%.
CONCLUSIONS


Incorporating additional supports into housing voucher programs may help support teenage boys who experience disruptions to their social networks, to buffer potential adverse consequences of residential mobility.",2020,"Having friends who used drugs marginally mediated the MTO treatment effect on RBI (indirect effect: B (SE) = 0.02(.01), 95% CI -0.002, 0.04), reducing the total treatment effect by 39%.
","[""adolescent boys' risky behaviors""]",['Section 8 rental voucher or a public housing control group'],"['total treatment effect', 'risky sexual behavior', 'global risky behavior index (RBI', 'peer social relationships (e.g., peer drug use, peer gang membership']","[{'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0034028', 'cui_str': 'Public Housing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}]",,0.0719186,"Having friends who used drugs marginally mediated the MTO treatment effect on RBI (indirect effect: B (SE) = 0.02(.01), 95% CI -0.002, 0.04), reducing the total treatment effect by 39%.
","[{'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Schmidt', 'Affiliation': 'Minnesota Population Center, University of Minnesota, Minneapolis. Electronic address: schmidtn@umn.edu.'}, {'ForeName': 'Naomi Harada', 'Initials': 'NH', 'LastName': 'Thyden', 'Affiliation': 'Department of Epidemiology and Community Health, University of Minnesota School of Public Health, Minneapolis.'}, {'ForeName': 'Huiyun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Minnesota Population Center, University of Minnesota, Minneapolis.'}, {'ForeName': 'Theresa L', 'Initials': 'TL', 'LastName': 'Osypuk', 'Affiliation': 'Minnesota Population Center, University of Minnesota, Minneapolis; Department of Epidemiology and Community Health, University of Minnesota School of Public Health, Minneapolis.'}]",Annals of epidemiology,['10.1016/j.annepidem.2020.05.007']
1378,32651634,Intermittent versus continuous enteral nutrition attenuates increases in insulin and leptin during short-term bed rest.,"PURPOSE


To compare endocrine responses to intermittent vs continuous enteral nutrition provision during short-term bed rest.
METHODS


Twenty healthy men underwent 7 days of bed rest, during which they were randomized to receive enteral nutrition (47%E as carbohydrate, 34%E as fat, 16%E as protein and 3%E as fibre) in a continuous (CONTINUOUS; n = 10; 24 h day -1  at a constant rate) or intermittent (INTERMITTENT; n = 10; as 4 meals per day separated by 5 h) pattern. Daily plasma samples were taken every morning to assess metabolite/hormone concentrations.
RESULTS


During bed rest, plasma leptin concentrations were elevated to a lesser extent with INTERMITTENT vs CONTINUOUS (iAUC: 0.42 ± 0.38 vs 0.95 ± 0.48 nmol L -1 , respectively; P = 0.014) as were insulin concentrations (interaction effect, P < 0.001) which reached a peak of 369 ± 225 pmol L -1  in CONTINUOUS, compared to 94 ± 38 pmol L -1  in INTERMITTENT (P = 0.001). Changes in glucose infusion rate were positively correlated with changes in fasting plasma GLP-1 concentrations (r = 0.44, P = 0.049).
CONCLUSION


Intermittent enteral nutrition attenuates the progressive rise in plasma leptin and insulinemia seen with continuous feeding during bed rest, suggesting that continuous feeding increases insulin requirements to maintain euglycemia. This raises the possibility that hepatic insulin sensitivity is impaired to a greater extent with continuous versus intermittent feeding during bed rest. To attenuate endocrine and metabolic changes with enteral feeding, an intermittent feeding strategy may, therefore, be preferable to continuous provision of nutrition. This trial was registered on clinicaltrials.gov as NCT02521025.",2020,"During bed rest, plasma leptin concentrations were elevated to a lesser extent with INTERMITTENT vs CONTINUOUS (iAUC: 0.42 ± 0.38 vs 0.95 ± 0.48 nmol L -1 , respectively; P = 0.014) as were insulin concentrations (interaction effect, P < 0.001) which reached a peak of 369 ± 225 ","['Twenty healthy men underwent 7\xa0days of bed rest, during which they were randomized to receive']","['enteral nutrition (47%E as carbohydrate, 34%E as fat, 16%E as protein and 3%E as fibre', 'continuous enteral nutrition']","['Changes in glucose infusion rate', 'insulin concentrations (interaction effect', 'insulin and leptin', 'fasting plasma GLP-1 concentrations', 'plasma leptin concentrations']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}]","[{'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]",20.0,0.0678729,"During bed rest, plasma leptin concentrations were elevated to a lesser extent with INTERMITTENT vs CONTINUOUS (iAUC: 0.42 ± 0.38 vs 0.95 ± 0.48 nmol L -1 , respectively; P = 0.014) as were insulin concentrations (interaction effect, P < 0.001) which reached a peak of 369 ± 225 ","[{'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Department for Health, University of Bath, Bath, UK. J.T.Gonzalez@bath.ac.uk.'}, {'ForeName': 'Marlou L', 'Initials': 'ML', 'LastName': 'Dirks', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+ (MUMC+), Maastricht, The Netherlands.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Holwerda', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+ (MUMC+), Maastricht, The Netherlands.'}, {'ForeName': 'Imre W K', 'Initials': 'IWK', 'LastName': 'Kouw', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+ (MUMC+), Maastricht, The Netherlands.'}, {'ForeName': 'Luc J C', 'Initials': 'LJC', 'LastName': 'van Loon', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+ (MUMC+), Maastricht, The Netherlands.'}]",European journal of applied physiology,['10.1007/s00421-020-04431-4']
1379,32649584,The Effect of Interactive Educational Workshops With or Without Standardized Patients on the Clinical Skills of Midwifery Students in Providing Sexual Health Counseling.,"BACKGROUND AND OBJECTIVES


Insufficient skills among health personnel, including midwives, can lead to failure in evaluating and providing sexual health counseling services to clients. Thus, the purpose of this study was to compare the effect of 2 interactive educational workshops with or without standardized patients (SPs) on midwifery students' clinical skills in providing sexual health counseling at Mashhad University of Medical Sciences, Mashhad, Iran, in 2014 to 2015.
RESEARCH METHODS


In this randomized controlled trial, 62 midwifery students were selected through convenient sampling method and then randomly divided into 2 groups who received 1 of 2 interactive educational workshops, with or without SPs in 10-hour educational programs. The students' skills in providing sexual health counseling were evaluated before and 2 weeks after the education through an Objective Structured Clinical Examination composed of 5 stations using validated checklists. The data were then analyzed using the SPSS Software (Version 16) through descriptive statistics as well as independent t test, paired t test, Mann-Whitney U, χ, and Fisher exact tests. The level of significance was considered by P < 0.05.
RESULTS


There was no significant difference between the mean scores of students' clinical skills in providing sexual health counseling services in the group educated with or without SPs (22.4 ± 7.0 and 23.0 ± 9.4, P = 0.77). However, 2 weeks after the interventions, the mean scores were 75.8 ± 11.2 and 47.0 ± 8.9, respectively, meaning a significant difference between the study groups (P < 0.0001).
CONCLUSIONS


Although both teaching methods could promote clinical skills among the midwifery students, the effect of interactive workshop with SPs was much significantly stronger.",2020,"There was no significant difference between the mean scores of students' clinical skills in providing sexual health counseling services in the group educated with or without SPs (22.4 ± 7.0 and 23.0 ± 9.4, P = 0.77).","['Patients on the Clinical Skills of Midwifery Students in Providing Sexual Health Counseling', '62 midwifery students', ""midwifery students' clinical skills in providing sexual health counseling at Mashhad University of Medical Sciences, Mashhad, Iran, in 2014 to 2015""]","['Interactive Educational Workshops With or Without Standardized', '2 interactive educational workshops with or without standardized patients (SPs', '2 interactive educational workshops, with or without SPs in 10-hour educational programs']","[""mean scores of students' clinical skills in providing sexual health counseling services"", 'mean scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008973', 'cui_str': 'Clinical Skills'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008973', 'cui_str': 'Clinical Skills'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",62.0,0.0304016,"There was no significant difference between the mean scores of students' clinical skills in providing sexual health counseling services in the group educated with or without SPs (22.4 ± 7.0 and 23.0 ± 9.4, P = 0.77).","[{'ForeName': 'Talat', 'Initials': 'T', 'LastName': 'Khadivzadeh', 'Affiliation': 'From the Nursing and Midwifery Care Research Center (T.K.), School of Nursing and Midwifery, Mashhad University of Medical Sciences; Department of Midwifery (M.A.S.S.), School of Nursing and Midwifery, Mashhad University of Medical Sciences; Department of Midwifery (K.M.), School of Nursing and Midwifery, Mashhad University of Medical Sciences; and Department of Medical-Surgical Nursing (S.R.M.), School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Ardaghi Sefat Seighalani', 'Affiliation': ''}, {'ForeName': 'Khadijeh', 'Initials': 'K', 'LastName': 'Mirzaii', 'Affiliation': ''}, {'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Mazloum', 'Affiliation': ''}]",Simulation in healthcare : journal of the Society for Simulation in Healthcare,['10.1097/SIH.0000000000000439']
1380,32650155,Comparative effects of water- and land-based combined exercise training in hypertensive older adults.,"OBJECTIVES


A randomized controlled trial was designed to compare water- and land-based combined (aerobic and resistance) exercise training programs on cardiometabolic parameters, functional fitness, and quality-of-life (QoL) in hypertensive older adults.
METHODS


Fifty-three participants were divided into three groups: 1) land-based exercise group (LET, n=17), 2) water-based exercise group (WET, n=16), and 3) control group (CON, n=20). All programs comprised of a 12-week supervised training program (three 1-hr sessions per week), followed by a 12-week self-supervised training program. Blood pressure (BP), glutathione peroxidase (GPx), total nitrite/nitrate (NOx-), malondialdehyde (MDA), high-sensitive C-reactive protein (hs-CRP), blood lipids, functional fitness, and QoL were assessed before and after each period.
RESULTS


Following the supervised period, systolic BP, rate-pressure product, GPx, NOx-, MDA, hs-CRP concentrations, physical and psychological domains, and overall QoL significantly improved in both training groups. Only the WET improved LDL-C and lipoprotein combine index. Meanwhile, the 30s chair-stand test and 2-min step test improved only in the LET. Succeeding the self-supervised period, systolic BP and NOx- concentration significantly improved in both training groups. Notwithstanding, the 30s chair-standing and arm curl tests improved only in the LET.
CONCLUSIONS


Both training programs rendered ameliorated systolic BP, antioxidant capacity and inflammation, muscular strength, aerobic endurance and QoL with a higher progression in the LET. Nevertheless, metabolic variables were greater improved in the WET. Additionally, due to greater exercise participation, the WET program may be a useful tool in motivating hypertensive older adults to continuously exercise on their own.",2020,"Both training programs rendered ameliorated systolic BP, antioxidant capacity and inflammation, muscular strength, aerobic endurance and QoL with a higher progression in the LET.","['hypertensive older adults', 'motivating hypertensive older adults', 'Fifty-three participants were divided into three groups: 1']","['water- and land-based combined (aerobic and resistance) exercise training programs', 'land-based exercise group (LET, n=17), 2) water-based exercise group (WET, n=16), and 3) control group (CON', 'supervised training program', 'water- and land-based combined exercise training']","['metabolic variables', 'ameliorated systolic BP, antioxidant capacity and inflammation, muscular strength, aerobic endurance and QoL', 'cardiometabolic parameters, functional fitness, and quality-of-life (QoL', 'systolic BP and NOx- concentration', 'Blood pressure (BP), glutathione peroxidase (GPx), total nitrite/nitrate (NOx-), malondialdehyde (MDA), high-sensitive C-reactive protein (hs-CRP), blood lipids, functional fitness, and QoL', 'LDL-C and lipoprotein combine index', 'systolic BP, rate-pressure product, GPx, NOx-, MDA, hs-CRP concentrations, physical and psychological domains, and overall QoL']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0086562', 'cui_str': 'Energy Transfer, Linear'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",53.0,0.0142118,"Both training programs rendered ameliorated systolic BP, antioxidant capacity and inflammation, muscular strength, aerobic endurance and QoL with a higher progression in the LET.","[{'ForeName': 'Ratree', 'Initials': 'R', 'LastName': 'Ruangthai', 'Affiliation': 'Department of Sports Science and Health, Faculty of Sports Science, Kasetsart University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Jatuporn', 'Initials': 'J', 'LastName': 'Phoemsapthawee', 'Affiliation': 'Department of Sports Science and Health, Faculty of Sports Science, Kasetsart University, Nakhon Pathom, Thailand. Electronic address: jatuporn.w@ku.th.'}, {'ForeName': 'Niromlee', 'Initials': 'N', 'LastName': 'Makaje', 'Affiliation': 'Department of Sports Science and Health, Faculty of Sports Science, Kasetsart University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Phornphon', 'Initials': 'P', 'LastName': 'Phimphaphorn', 'Affiliation': 'Department of Sports Science and Health, Faculty of Sports Science, Kasetsart University, Nakhon Pathom, Thailand.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104164']
1381,32650548,A Multidisciplinary Approach for Improving Quality of Life and Self-Management in Diabetic Kidney Disease: A Crossover Study.,"Individuals with diabetic kidney disease are at high risk of complications and challenged to self-manage. Previous research suggested that multidisciplinary approaches would improve health outcomes. This study investigated the effect of a multidisciplinary self-management approach of diabetic kidney disease on quality of life, and self-management, glycemic control, and renal function. A uniform balanced crossover design was used because it attains a high level of statistical power with a lower sample size. A total of 32 participants (aged 67.8 ± 10.8) were randomized into four study arms. In differing sequences, each participant was treated twice with three months of usual care alternated with three months of multidisciplinary management. The intervention improved the present dimension of quality of life demonstrating higher mean rank as compared to usual care (52.49 vs. 41.01;  p  = 0.026, 95% CI) and three self-care activities, general diet habits, diabetes diet habits, and blood sugar testing (respectively: 55.43 vs. 38.31;  p  = 0.002, 56.84 vs. 37.02;  p  = 0.000, 53.84 vs. 39.77;  p  = 0.008; 95% CI). Antihypertensive medication engagement was high across the study period (Mean = 95.38%, Min = 69%, Max = 100%). Glycemic control and renal function indicators were similar for the intervention and the usual care. Studies are needed to determine how the new recommended therapies for diabetic kidney disease such as SGLT2 inhibitors and GLP-1 receptor agonists impact on self-management and quality of life.",2020,"The intervention improved the present dimension of quality of life demonstrating higher mean rank as compared to usual care (52.49 vs. 41.01;  p  = 0.026, 95% CI) and three self-care activities, general diet habits, diabetes diet habits, and blood sugar testing (respectively: 55.43 vs. 38.31;  ","['Diabetic Kidney Disease', '32 participants (aged 67.8 ± 10.8', 'Individuals with diabetic kidney disease']",['multidisciplinary self-management approach'],"['Antihypertensive medication engagement', 'Glycemic control and renal function indicators', 'Quality of Life and Self-Management', 'self-care activities, general diet habits, diabetes diet habits, and blood sugar testing', 'health outcomes', 'quality of life, and self-management, glycemic control, and renal function', 'present dimension of quality of life']","[{'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0301563', 'cui_str': 'General diet'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",32.0,0.0424056,"The intervention improved the present dimension of quality of life demonstrating higher mean rank as compared to usual care (52.49 vs. 41.01;  p  = 0.026, 95% CI) and three self-care activities, general diet habits, diabetes diet habits, and blood sugar testing (respectively: 55.43 vs. 38.31;  ","[{'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Helou', 'Affiliation': 'School of Health Sciences (HESAV), HES-SO University of Applied Sciences and Arts Western Switzerland, 1011 Lausanne, Switzerland.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Talhouedec', 'Affiliation': 'Clinique de La Source, 1004 Lausanne, Switzerland.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Zumstein-Shaha', 'Affiliation': 'Department of Health, Bern University of Applied Sciences, 3010 Bern, Switzerland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Zanchi', 'Affiliation': 'Service of Nephrology and Hypertension, Service of Endocrinology, Diabetes and Metabolism, Department of Medicine, Lausanne University Hospital and University of Lausanne, 1011 Lausanne, Switzerland.'}]",Journal of clinical medicine,['10.3390/jcm9072160']
1382,32652462,Improving medication adherence with adjuvant aromatase inhibitor in women with breast cancer: A randomised controlled trial to evaluate the effect of short message service (SMS) reminder.,"BACKGROUND


Medication adherence is crucial for improving clinical outcomes in the treatment of patients. We evaluate the effect of short message service (SMS) reminder on medication adherence and serum hormones in patients with breast cancer on aromatase inhibitors.
METHODS


An open-label, multi-centre, prospective randomised controlled trial of SMS versus Standard Care was conducted. Medication adherence was assessed via self-report using the Simplified Medication Adherence Questionnaire at baseline, 6 month, and 1 year. Androstenedione, estradiol, and estrone were measured at baseline and 1 year. The χ 2  test and mixed effects logistic regression was performed to compare medication adherence between groups. Difference in androstenedione and estrone levels were assessed using analysis of covariance, whereas χ 2  test and logistic regression was used for estradiol. Analysis was based on intention-to-treat.
RESULTS


A total of 244 patients were randomised to receive weekly SMS reminder (n = 123) or Standard Care (n = 121) between May 2015 and December 2018. The odds of adherence was higher at 6-month in SMS (OR = 1.78, 95% CI 1.04-3.05, p = 0.034), and not significantly different at 1-year (OR = 1.15, 95% CI: 0.67-1.96 p = 0.617). Mixed effects logistic regression analysis showed higher odds of adherence in SMS over the 1-year period (OR = 2.35, 95% CI: 1.01-5.49, p = 0.048). There was no difference in serum hormone levels between groups.
CONCLUSION


SMS reminder improved medication adherence in the short-term but had no effect on serum hormones levels in the longer term. Future studies could investigate the use of tailored SMS intervention according to patient preference to improve its sustainability.",2020,"CONCLUSION


SMS reminder improved medication adherence in the short-term but had no effect on serum hormones levels in the longer term.","['patients with breast cancer on aromatase inhibitors', 'patients', '244 patients', 'women with breast cancer']","['short message service (SMS) reminder', 'SMS', 'adjuvant aromatase inhibitor', 'SMS intervention', 'SMS reminder (n\xa0=\xa0123) or Standard Care']","['Medication adherence', 'Androstenedione, estradiol, and estrone', 'medication adherence and serum hormones', 'odds of adherence', 'serum hormones levels', 'androstenedione and estrone levels', 'serum hormone levels', 'medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0002860', 'cui_str': 'Androstenedione'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0236379', 'cui_str': 'Estrone measurement'}]",244.0,0.22356,"CONCLUSION


SMS reminder improved medication adherence in the short-term but had no effect on serum hormones levels in the longer term.","[{'ForeName': 'Eng Hooi', 'Initials': 'EH', 'LastName': 'Tan', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, 12 Science Drive 2, #10-03F, 117549, Singapore.'}, {'ForeName': 'Andrea Li Ann', 'Initials': 'ALA', 'LastName': 'Wong', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Chuan Chien', 'Initials': 'CC', 'LastName': 'Tan', 'Affiliation': 'Department of General Surgery, Ng Teng Fong General Hospital, 1 Jurong East Street 21, 609606, Singapore.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Wong', 'Affiliation': 'Division of Oncology Pharmacy, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Sing Huang', 'Initials': 'SH', 'LastName': 'Tan', 'Affiliation': 'OncoCare Cancer Centre, 6 Napier Road, #02-17/18/19, Gleneagles Medical Centr, 258499, Singapore.'}, {'ForeName': 'Li En Yvonne', 'Initials': 'LEY', 'LastName': 'Ang', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Siew Eng', 'Initials': 'SE', 'LastName': 'Lim', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Wan Qin', 'Initials': 'WQ', 'LastName': 'Chong', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Jingshan', 'Initials': 'J', 'LastName': 'Ho', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Soo Chin', 'Initials': 'SC', 'LastName': 'Lee', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Bee Choo', 'Initials': 'BC', 'LastName': 'Tai', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, 12 Science Drive 2, #10-03F, 117549, Singapore; Yong Loo Lin School of Medicine, National University of Singapore and National University Health System, 1E Kent Ridge Road, 119228, Singapore. Electronic address: ephtbc@nus.edu.sg.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.06.012']
1383,32621905,The ENGAGE-2 study: Engaging self-regulation targets to understand the mechanisms of behavior change and improve mood and weight outcomes in a randomized controlled trial (Phase 2).,"Despite evidence for effective integrated behavior therapy for treating comorbid obesity and depression, treatment response is highly variable and the underlying neurobiological mechanisms remain unknown. This hampers efforts to identify mechanistic targets in order to optimize treatment precision and potency. Funded within the NIH Science of Behavior Change (SOBC) Research Network, the 2-phased ENGAGE research project applies an experimental precision medicine approach to address this gap. The Phase 1 study focused on demonstrating technical feasibility, target engagement and potential neural mechanisms of responses to an integrated behavior therapy. This therapy combines a video-based behavioral weight loss program and problem-solving therapy for depression, with as-needed intensification of antidepressant medications, and its clinical effectiveness was demonstrated within a parent randomized clinical trial. Here, we describe the ENGAGE Phase 2 (ENGAGE-2) study protocol which builds on Phase 1 in 2 ways: (1) pilot testing of an motivational interviewing-enhanced, integrated behavior therapy in an independent, primarily minority patient sample, and (2) evaluation of a priori defined neural targets, specifically the negative affect (threat and sadness) circuits which demonstrated engagement and malleability in Phase 1, as mediators of therapeutic outcomes. Additionally, the Phase 2 study includes a conceptual and methodological extension to explore the role of microbiome-gut-brain and systemic immunological pathways in integrated behavioral treatment of obesity and depression. This protocol paper documents the conceptualization, design and the transdisciplinary methodologies in ENGAGE-2, which can inform future clinical and translational research in experimental precision medicine for behavior change and chronic disease management. Trial registration: ClinicalTrials.gov #NCT 03,841,682.",2020,"The Phase 1 study focused on demonstrating technical feasibility, target engagement and potential neural mechanisms of responses to an integrated behavior therapy.",[],"['motivational interviewing-enhanced, integrated behavior therapy', 'video-based behavioral weight loss program and problem-solving therapy']",[],[],"[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}]",[],,0.0347898,"The Phase 1 study focused on demonstrating technical feasibility, target engagement and potential neural mechanisms of responses to an integrated behavior therapy.","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lv', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Olusola A', 'Initials': 'OA', 'LastName': 'Ajilore', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL 60612, United States.'}, {'ForeName': 'Corina R', 'Initials': 'CR', 'LastName': 'Ronneberg', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Venditti', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, United States.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Snowden', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA 98104, United States.'}, {'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Lavori', 'Affiliation': 'Department of Biomedical Data Science, Stanford University, Stanford, CA 94305, United States.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, Palo Alto, CA 94304, United States.'}, {'ForeName': 'Andrea N', 'Initials': 'AN', 'LastName': 'Goldstein-Piekarski', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, United States; MIRECC VISN21, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA 94304, United States.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Wielgosz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, United States.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Wittels', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Amruta', 'Initials': 'A', 'LastName': 'Barve', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Aashutos S', 'Initials': 'AS', 'LastName': 'Patel', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Tessa L', 'Initials': 'TL', 'LastName': 'Eckley', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Stetz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, United States.'}, {'ForeName': 'Ben S', 'Initials': 'BS', 'LastName': 'Gerber', 'Affiliation': 'Division of Academic Internal Medicine and Geriatrics, College of Medicine, University of Illinois at Chicago, Chicago, IL 60612, United States.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Smyth', 'Affiliation': 'Departments of Biobehavioral Health and Medicine, Pennsylvania State University, University Park, PA 16802, United States.'}, {'ForeName': 'Janine M', 'Initials': 'JM', 'LastName': 'Simmons', 'Affiliation': 'National Institute of Mental Health (NIMH), National Institutes of Health, Bethesda, MD 20892, United States.'}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Rosas', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, Palo Alto, CA 94304, United States; Department of Medicine, Stanford University, Palo Alto, CA 94304, United States.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, United States; MIRECC VISN21, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA 94304, United States.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States; Department of Medicine, University of Illinois at Chicago, Chicago, IL 60608, United States. Electronic address: maj2015@uic.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106072']
1384,32622071,Delta-like 1 (DLK1) is a possible mediator of vitamin D effects on bone and energy metabolism.,"Vitamin D effects on bone and mineral metabolism are well recognized, and its anti-inflammatory actions are gaining particular interest. Delta-like 1 (DLK1) is a protein, expressed by progenitor cells of different tissues, and increases the size of progenitor cell population during the inflammatory phase of tissue regeneration. DLK1 also plays a role in energy metabolism as it antagonizes insulin signaling in bone. In this one-year randomized clinical trial of overweight elderly individuals that received either 600 or 3750 IU daily cholecalciferol we assessed the effect of vitamin D supplementation on pre-specified secondary outcomes: DLK1, leptin, adiponectin, C-Reactive Protein (CRP) and Vascular Cell Adhesion Molecule (VCAM). We also examined correlations between DLK1 and bone (BMD, bone markers), fat (adipokines, body composition), insulin sensitivity and inflammatory markers. Multivariate analyses were conducted to further explore these associations. Overall, there was a significant increase in serum DLK1 and leptin and a decrease in VCAM, but no change in CRP, after 12 months of vitamin D supplementation. DLK1 was negatively correlated with BMD and positively correlated with bone markers, associations that persisted after adjusting for age, gender and BMI. DLK1 was also positively associated with indices of insulin resistance and negatively with indices of insulin sensitivity. Correlations between DLK1 and fat parameters, such as adipokines, and DXA derived fat mass were less consistent. There were no correlations between DLK1 and inflammatory markers. In conclusion, twelve months supplementation of vitamin D3 increased serum DLK1. DLK1 was negatively associated with indices of bone health and fuel metabolism, and with 1,25(OH) 2 D levels. Similar to the role of DLK1 in animal models, our findings support the hypothesis that DLK1 can be targeted to regulate bone and energy metabolism and develop drugs to improve BMD and insulin sensitivity. However, further studies are needed to explore the role of DLK1 and its relationship to vitamin D metabolites in vivo.",2020,"Correlations between DLK1 and fat parameters, such as adipokines, and DXA derived fat mass were less consistent.",['overweight elderly individuals'],"['Vitamin D', 'Delta-like 1 (DLK1', '600 or 3750\u202fIU daily cholecalciferol', 'vitamin D supplementation', 'vitamin D3']","['bone health and fuel metabolism, and with 1,25(OH) 2 D levels', 'serum DLK1 and leptin', 'serum DLK1', 'DLK1 and inflammatory markers', 'DLK1', 'BMD and insulin sensitivity', 'leptin, adiponectin, C-Reactive Protein (CRP) and Vascular Cell Adhesion Molecule (VCAM', 'VCAM', 'DLK1and bone (BMD, bone markers), fat (adipokines, body composition), insulin sensitivity and inflammatory markers', 'bone and mineral metabolism', 'insulin resistance and negatively with indices of insulin sensitivity']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517746', 'cui_str': '3750'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0181734', 'cui_str': 'Bone marker'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0714769,"Correlations between DLK1 and fat parameters, such as adipokines, and DXA derived fat mass were less consistent.","[{'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Bassatne', 'Affiliation': 'Calcium Metabolism and Osteoporosis Program, Division of Endocrinology and Metabolism, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Jafari', 'Affiliation': 'Molecular Endocrinology and Stem Cell Research Unit (KMEB), Department of Endocrinology and Metabolism, Odense University Hospital and Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Department of Cellular and Molecular Medicine, Novo Nordisk Foundation Center for Stem Cell Biology (DanStem), University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Moustapha', 'Initials': 'M', 'LastName': 'Kassem', 'Affiliation': 'Molecular Endocrinology and Stem Cell Research Unit (KMEB), Department of Endocrinology and Metabolism, Odense University Hospital and Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Mantzoros', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Rahme', 'Affiliation': 'Calcium Metabolism and Osteoporosis Program, Division of Endocrinology and Metabolism, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Ghada', 'Initials': 'G', 'LastName': 'El-Hajj Fuleihan', 'Affiliation': 'Calcium Metabolism and Osteoporosis Program, Division of Endocrinology and Metabolism, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon. Electronic address: gf01@aub.edu.lb.'}]",Bone,['10.1016/j.bone.2020.115510']
1385,32629091,Early-onset pneumonia following bag-mask ventilation versus endotracheal intubation during cardiopulmonary resuscitation: A substudy of the CAAM trial.,"AIM


Early-onset pneumonia (EOP) is a common in-hospital complication in survivors of out-of-hospital cardiac arrest. In this substudy of the CAAM trial, we aimed to compare whether bag mask ventilation (BMV) compared to endotracheal intubation (ETI) performed during cardiopulmonary resuscitation increases the risk of developing EOP.
METHODS


Adult patients from the CAAM trial that survived beyond 12 h of hospitalization were included. Information about in-hospital management and outcome of study subjects was systematically collected. Our primary aim was to compare the incidence of EOP in the BMV and ETI group using a series of bivariate analysis adjusting for one variable at a time and a logistic regression controlled for survival beyond 96 h, age, gender, catecholamine administration, no flow time, and initial shockable rhythm.
RESULTS


Of 627 patients from the CAAM trial that survived to hospital admission, 409 patients were hospitalized beyond 12 h and thus included (202 randomized to BMV and 20 7 randomized to ETI). Patients in the BMV group had a significantly longer period of unsecured airway during prehospital cardiopulmonary resuscitation (BMV (median): 33 min; ETI (median): 17 min, p < 0.0001). No significant difference in the development of EOP according to airway management was identified on univariate analysis (BMV: 53%, ETI: 53%, Odds Ratio 1.0 [0.7-1.5], p = 1.0). We found no difference in the development of EOP according to airway management in the series of bivariate analyses or in the multivariable regression analysis either.
CONCLUSION


In this substudy of the CAAM trial, development of early-onset pneumonia in out-of-hospital cardiac arrest survivors did not depend on airway management technique during CPR.",2020,"No significant difference in the development of EOP according to airway management was identified on univariate analysis (BMV: 53%, ETI: 53%, Odds Ratio 1.0 [0.7 - 1.5], p = 1.0).","['cardiopulmonary resuscitation', 'Adult patients from the CAAM trial that survived beyond 12\u2009hours of hospitalization were included', '627 patients from the CAAM trial that survived to hospital admission', '409 patients were hospitalized beyond 12\u2009hours and thus included (202 randomized to BMV and 20 7 randomized to ETI']","['endotracheal intubation (ETI', 'bag-mask ventilation versus endotracheal intubation', 'bag mask ventilation (BMV']","['development of EOP according to airway management', 'risk of developing EOP', 'incidence of EOP']","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",627.0,0.0603892,"No significant difference in the development of EOP according to airway management was identified on univariate analysis (BMV: 53%, ETI: 53%, Odds Ratio 1.0 [0.7 - 1.5], p = 1.0).","[{'ForeName': 'Josefine S', 'Initials': 'JS', 'LastName': 'Baekgaard', 'Affiliation': 'Department of Anesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Denmark; Urgences et Samu 93, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France. Electronic address: josefine.stokholm.baekgaard.01@regionh.dk.'}, {'ForeName': 'Mohamed N', 'Initials': 'MN', 'LastName': 'Triba', 'Affiliation': ""Sorbonne Paris Cité, Equipe Nanomédecine Biomarqueurs Détection, Laboratoire de Chimie, Structures et Propriétés de Biomateriaux et d'Agents Therapeutiques, UMR CNRS 7244, University Paris 13 Bobigny, France.""}, {'ForeName': 'Morgane', 'Initials': 'M', 'LastName': 'Brandeis', 'Affiliation': 'Service des Urgences, Hopital Ballanger, 93600 Aulnays, France.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Steinmetz', 'Affiliation': 'Department of Anesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Cohen', 'Affiliation': 'Intensive Care Unit, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Gorlicki', 'Affiliation': 'Urgences et Samu 93, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France.'}, {'ForeName': 'Lars S', 'Initials': 'LS', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Anesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Deltour', 'Affiliation': 'Urgences et Samu 93, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Lapostolle', 'Affiliation': 'Urgences et Samu 93, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Adnet', 'Affiliation': 'Urgences et Samu 93, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France.'}]",Resuscitation,['10.1016/j.resuscitation.2020.06.011']
1386,32630663,Intensive Motion Style Acupuncture Treatment (MSAT) Is Effective for Patients with Acute Whiplash Injury: A Randomized Controlled Trial.,"In this single-center, parallel, randomized controlled trial, we aim to examine the effects and safety of motion style acupuncture treatment (MSAT; a combination of acupuncture and Doin therapy) on pain reduction and functional improvement in patients with whiplash-associated disorders (WADs). Ninety-seven patients with cervical pain admitted to the Bucheon Jaseng Hospital of Korean Medicine, South Korea, due to acute whiplash injury were treated with integrative Korean medicine (IKM) with (MSAT group, 48 patients) or without (control group, 49 patients) an additional 3-day MSAT during hospitalization (5-14 days) and followed-up for 90 days. The mean numeric rating scale (NRS) scores of the MSAT and control groups at baseline were 5.67 (95% confidence interval (CI), 5.33, 6.01) and 5.44 (95% CI, 5.06, 5.82), respectively, and on day 5, 3.55 (95% CI, 3.04, 4.06) and 4.59 (95% CI, 4.10-5.07), respectively. The NRS change difference between the groups was -1.07 (95% CI, -1.76, -0.37). The rate of recovery of neck pain (NRS score change ≥ 2 points) was significantly faster in the MSAT than in the control group (log-rank test  p  = 0.0055). IKM treatment combined with MSAT may be effective in reducing the pain and improving the range of motion in patients with WADs.",2020,The rate of recovery of neck pain (NRS score change ≥ 2 points) was significantly faster in the MSAT than in the control group (log-rank test  p  = 0.0055).,"['Patients with Acute Whiplash Injury', 'patients with WADs', 'Ninety-seven patients with cervical pain admitted to the Bucheon Jaseng Hospital of Korean Medicine, South Korea, due to acute whiplash injury', 'patients with whiplash-associated disorders (WADs']","['Intensive Motion Style Acupuncture Treatment (MSAT', 'acupuncture and Doin therapy', 'integrative Korean medicine (IKM) with (MSAT group, 48 patients) or without (control group, 49 patients) an additional 3-day MSAT', 'MSAT', 'motion style acupuncture treatment (MSAT']","['NRS change difference', 'mean numeric rating scale (NRS) scores', 'pain', 'pain reduction and functional improvement', 'rate of recovery of neck pain (NRS score change ≥ 2 points']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0043145', 'cui_str': 'Whiplash injury to neck'}, {'cui': 'C1292726', 'cui_str': 'Associated disorder'}, {'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}]",97.0,0.231885,The rate of recovery of neck pain (NRS score change ≥ 2 points) was significantly faster in the MSAT than in the control group (log-rank test  p  = 0.0055).,"[{'ForeName': 'Doori', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'Bucheon Jaseng Hospital of Korean Medicine, Bucheon 420010, Korea.'}, {'ForeName': 'Kyoung-Sun', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Jaseng Spine and Joint Research Institute, Jaseng Medical Foundations, Gangnam-gu, Seoul 100011, Korea.'}, {'ForeName': 'Jin-Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Jaseng Hospital of Korean Medicine, Gangnam-gu, Seoul 100011, Korea.'}, {'ForeName': 'Won-Hyung', 'Initials': 'WH', 'LastName': 'Ryu', 'Affiliation': 'Bucheon Jaseng Hospital of Korean Medicine, Bucheon 420010, Korea.'}, {'ForeName': 'Heeyoung', 'Initials': 'H', 'LastName': 'Moon', 'Affiliation': 'Bucheon Jaseng Hospital of Korean Medicine, Bucheon 420010, Korea.'}, {'ForeName': 'Jiwon', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Bucheon Jaseng Hospital of Korean Medicine, Bucheon 420010, Korea.'}, {'ForeName': 'Yong-Hyun', 'Initials': 'YH', 'LastName': 'Jeon', 'Affiliation': 'Bucheon Jaseng Hospital of Korean Medicine, Bucheon 420010, Korea.'}, {'ForeName': 'Ji-Yeon', 'Initials': 'JY', 'LastName': 'Seo', 'Affiliation': 'Bucheon Jaseng Hospital of Korean Medicine, Bucheon 420010, Korea.'}, {'ForeName': 'Young-Joo', 'Initials': 'YJ', 'LastName': 'Moon', 'Affiliation': 'Bucheon Jaseng Hospital of Korean Medicine, Bucheon 420010, Korea.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Namgoong', 'Affiliation': 'Bucheon Jaseng Hospital of Korean Medicine, Bucheon 420010, Korea.'}, {'ForeName': 'Byung-Cheul', 'Initials': 'BC', 'LastName': 'Shin', 'Affiliation': 'School of Korean Medicine, Pusan National University, Yangsan, Kyungnam 50612, Korea.'}, {'ForeName': 'In-Hyuk', 'Initials': 'IH', 'LastName': 'Ha', 'Affiliation': 'Jaseng Spine and Joint Research Institute, Jaseng Medical Foundations, Gangnam-gu, Seoul 100011, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9072079']
1387,32639465,Daptomycin for Pediatric Gram-Positive Acute Hematogenous Osteomyelitis.,"BACKGROUND


We prospectively evaluated efficacy and safety of daptomycin versus active comparator in children with acute hematogenous osteomyelitis (AHO).
METHODS


Randomized, controlled, double-blind, global, multicenter, phase 3 trial. Patients 1-17 years of age with suspected/confirmed AHO requiring hospitalization and intravenous therapy were randomized 1:1 to intravenous daptomycin (once-daily, age-adjusted doses) or comparator (vancomycin, nafcillin or equivalent) ≥4 days, followed by oral therapy (14-42 days total). Primary endpoint: protocol-defined clinical improvement by Day 5 in the modified intention-to-treat (MITT) population (confirmed AHO, ≥1 dose of study treatment); differences between study arms were evaluated using a prespecified 15% noninferiority margin for daptomycin.
RESULTS


Seventy-three patients per arm received treatment. Pathogens were isolated from 62% of patients (83% methicillin-susceptible Staphylococcus aureus, 9% methicillin-resistant S. aureus [MRSA]). Clinical improvement by Day 5 was observed in 55/71 (78%) daptomycin- and 58/70 (83%) comparator-treated MITT patients (95% confidence interval [CI]: -19.4, 7.4). This difference was not statistically significant; however, daptomycin did not meet the prespecified 15% noninferiority margin, since the lower bound of the 95% CI extended below 15%. Overall, 82% of daptomycin and 87% of comparator patients achieved clinical cure at the test-of-cure visit (secondary endpoint). More comparator patients had treatment-emergent (63% vs. 46%) and treatment-related (18% vs. 7%) adverse events.
CONCLUSIONS


Differences between daptomycin and comparator for the primary endpoint were not statistically significant; however, prespecified noninferiority criteria for daptomycin were not met. With insufficient cases of confirmed MRSA, we could not evaluate daptomycin for MRSA AHO. Our nonvalidated protocol design yields valuable information for implementing future trials in AHO (ClinicalTrials.gov NCT01922011).",2020,"comparator-treated MITT patients (95% confidence interval [CI]: -19.4, 7.4).","['Patients 1-17 years of age with suspected/confirmed AHO requiring hospitalization and intravenous therapy', 'children with acute hematogenous osteomyelitis (AHO']","['daptomycin', 'comparator (vancomycin, nafcillin or equivalent) ≥4 days, followed by oral therapy', 'intravenous daptomycin', 'Daptomycin']","['clinical cure', 'protocol-defined clinical improvement by Day 5 in the modified intention-to-treat (MITT) population (confirmed AHO, ≥1 dose of study treatment); differences', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0455142', 'cui_str': 'Intravenous therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0600123', 'cui_str': 'Acute hematogenous osteomyelitis'}]","[{'cui': 'C0057144', 'cui_str': 'Daptomycin'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0027324', 'cui_str': 'Nafcillin'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0600123', 'cui_str': 'Acute hematogenous osteomyelitis'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.601159,"comparator-treated MITT patients (95% confidence interval [CI]: -19.4, 7.4).","[{'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Bradley', 'Affiliation': ""From the Division of Infectious Diseases, Rady Children's Hospital San Diego, San Diego, CA.""}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Arrieta', 'Affiliation': ""Children's Hospital of Orange County, Orange, CA.""}, {'ForeName': 'Valeri A', 'Initials': 'VA', 'LastName': 'Digtyar', 'Affiliation': ""Dnipropetrovsk Regional Children's Clinical Hospital, Dnipropetrovsk, Ukraine.""}, {'ForeName': 'Myra W', 'Initials': 'MW', 'LastName': 'Popejoy', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Anjana', 'Initials': 'A', 'LastName': 'Grandhi', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Bokesch', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Hershberger', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Dorr', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Tan', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Murata', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Dominik J', 'Initials': 'DJ', 'LastName': 'Wolf', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Mekki', 'Initials': 'M', 'LastName': 'Bensaci', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002790']
1388,32634486,Team clinic: Expansion of a multidisciplinary care model for adolescents with type 1 diabetes.,"BACKGROUND


Adolescent and young adults (AYA) with Type 1 Diabetes (T1D) experience more difficulty with glycemic control than patients in all other age groups. The shared medical appointment (SMA) model has been effective in multiple healthcare populations, but the feasibility and effectiveness of SMA in AYA patients with T1D is unclear.
METHODS


This research leverages the team's multidisciplinary expertise to develop an engaging intervention toolkit and test the implementation of the Team Clinic care model for the treatment of T1D among middle school adolescents in a large urban children's hospital serving an economically, racially and ethnically diverse population. In Phase 1, the team will manualize the Team Clinic care model into an engaging, age-appropriate educational and intervention toolkit. In Phase 2, the team will conduct a randomized clinical trial to test the feasibility and usability of the toolkit from the provider perspective (team member satisfaction; clinical efficiency; compliance with American Diabetes Association, American Association of Diabetes Educators, and California Children's Services standards; and payor-level cost data) and the preliminary efficacy of the intervention toolkit on patient- and family-level outcomes (attendance, acceptability/satisfaction with care, patient-level cost data, diabetes outcomes, diabetes family conflict, diabetes distress, and depression).
DISCUSSION


AYA patients with T1D often receive care in clinics and institutions with limited resources and time. This research tests the feasibility and efficacy of an innovative and potentially cost-effective SMA model to address the unique needs of underserved populations, while meeting national and state clinical standards. Trial registration The study is registered with ClinicalTrials.gov (Protocol Record: NCT04190368).",2020,"This research tests the feasibility and efficacy of an innovative and potentially cost-effective SMA model to address the unique needs of underserved populations, while meeting national and state clinical standards.","['Adolescent and young adults (AYA) with Type 1 Diabetes (T1D) experience more difficulty with glycemic control than patients in all other age groups', 'adolescents with type 1 diabetes', 'patients with T1D often receive care in clinics and institutions with limited resources and time', ""middle school adolescents in a large urban children's hospital serving an economically, racially and ethnically diverse population""]",[],"['patient- and family-level outcomes (attendance, acceptability/satisfaction with care, patient-level cost data, diabetes outcomes, diabetes family conflict, diabetes distress, and depression']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0233542', 'cui_str': 'Family conflict'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.0267749,"This research tests the feasibility and efficacy of an innovative and potentially cost-effective SMA model to address the unique needs of underserved populations, while meeting national and state clinical standards.","[{'ForeName': 'Sarah-Jeanne', 'Initials': 'SJ', 'LastName': 'Salvy', 'Affiliation': 'Research Center for Health Equity, Cedars-Sinai Medical Center, United States of America.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Ruelas', 'Affiliation': 'Keck School of Medicine, University of Southern California, United States of America.'}, {'ForeName': 'Shideh', 'Initials': 'S', 'LastName': 'Majidi', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, United States of America.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': 'Booster Shot Media, United States of America.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Ashwal', 'Affiliation': 'Booster Shot Media, United States of America.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Reid', 'Affiliation': ""The Vision Center, Children's Hospital Los Angeles, United States of America.""}, {'ForeName': 'D Steven', 'Initials': 'DS', 'LastName': 'Fox', 'Affiliation': 'School of Pharmacy, University of Southern California, United States of America.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'McClain', 'Affiliation': 'School of Social Work, University of Southern California, United States of America.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Raymond', 'Affiliation': ""Center for Endocrinology, Diabetes, & Metabolism, Children's Hospital Los Angeles, United States of America. Electronic address: jraymond@chla.usc.edu.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106079']
1389,32634551,Effects of resistance training on hepcidin levels and iron bioavailability in older individuals with end-stage renal disease: A randomized controlled trial.,"Anemia is an inherent complication of older individuals with end-stage renal disease (ESRD) that is associated with inflammation which in turn is an important factor in the activation of hepcidin that contributes to the decrease in serum iron. Athough resistance training (RT) seems to reduce inflammation in ESRD, its influence on hepcidin and iron availability in hemodialysis patients is unclear. Therefore, the aim of this study was to exemine the effects of RT in on inflammatory profile, hepcidin, and iron status in older individuals with ESRD. End-stage renal disease patients (N: 157, age: 66.8 ± 3.6; body mass: 73 ± 15 body mass index:27 ± 3), were assigned to control (CTL n: 76) and exercise groups (RT n: 81). RT consisted of 24 weeks/3 days per week of a moderate intensity. There was an increase in the bioavailability of iron (ΔRT: 22.2; ΔCTL: -1 μg/dL, p < 0.0001), a decrease in hepcidin levels (ΔRT: -7.9; ΔCTL: 0.2 ng/mL, p < 0.0001),and an improvement of the inflammatory profile. These novel findings show that RT is a potential coadjuvant to reduce iron deficiency by decreasing the levels of hepcidin and pro-inflammatory markers in older patients undergoing hemodialysis.",2020,"There was an increase in the bioavailability of iron (ΔRT: 22.2; ΔCTL: -1 μg/dL, p < 0.0001), a decrease in hepcidin levels (ΔRT: -7.9; ΔCTL: 0.2 ng/mL, p < 0.0001),and an improvement of the inflammatory profile.","['N: 157, age: 66.8\u202f±\u202f3.6; body mass: 73\u202f±\u202f15 body mass index:27\u202f±\u202f3', 'older individuals with ESRD', 'older individuals with end-stage renal disease', 'older individuals with end-stage renal disease (ESRD', 'older patients undergoing hemodialysis', 'hemodialysis patients', 'End-stage renal disease patients']","['Athough resistance training (RT', 'RT', 'resistance training']","['inflammatory profile, hepcidin, and iron status', 'hepcidin levels and iron bioavailability', 'hepcidin levels', 'bioavailability of iron']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517844', 'cui_str': '66.8'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",157.0,0.0490397,"There was an increase in the bioavailability of iron (ΔRT: 22.2; ΔCTL: -1 μg/dL, p < 0.0001), a decrease in hepcidin levels (ΔRT: -7.9; ΔCTL: 0.2 ng/mL, p < 0.0001),and an improvement of the inflammatory profile.","[{'ForeName': 'Sting Ray Gouveia', 'Initials': 'SRG', 'LastName': 'Moura', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Hugo Luca', 'Initials': 'HL', 'LastName': 'Corrêa', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil. Electronic address: hugo.efucb@gmail.com.'}, {'ForeName': 'Rodrigo Vanerson Passos', 'Initials': 'RVP', 'LastName': 'Neves', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Cláudio Avelino Rodrigues', 'Initials': 'CAR', 'LastName': 'Santos', 'Affiliation': 'Federal University of Tocantins, Medicine Department, Tocantins, Brazil.'}, {'ForeName': 'Luiz Sinésio Silva', 'Initials': 'LSS', 'LastName': 'Neto', 'Affiliation': 'Federal University of Tocantins, Medicine Department, Tocantins, Brazil.'}, {'ForeName': 'Victor Lopes', 'Initials': 'VL', 'LastName': 'Silva', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Michel Kendy', 'Initials': 'MK', 'LastName': 'Souza', 'Affiliation': 'Federal University of Tocantins, Medicine Department, Tocantins, Brazil.'}, {'ForeName': 'Lysleine Alves', 'Initials': 'LA', 'LastName': 'Deus', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Andrea Lucena', 'Initials': 'AL', 'LastName': 'Reis', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Herbert Gustavo', 'Initials': 'HG', 'LastName': 'Simões', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Fabiani Lage Rodrigues', 'Initials': 'FLR', 'LastName': 'Beal', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Milton Rocha', 'Initials': 'MR', 'LastName': 'Moraes', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Navalta', 'Affiliation': 'University of Nevada, Las Vegas, Department of Kinesiology and Nutrition Sciences, Las Vegas, NV, USA.'}, {'ForeName': 'Jonato', 'Initials': 'J', 'LastName': 'Prestes', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'André Bonadias', 'Initials': 'AB', 'LastName': 'Gadelha', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil; Federal Institute of Education, Science and Technology Goiano, Goiás, Brazil.'}, {'ForeName': 'Thiago Dos Santos', 'Initials': 'TDS', 'LastName': 'Rosa', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}]",Experimental gerontology,['10.1016/j.exger.2020.111017']
1390,32634565,Optical Coherence Tomography Contribution Assessment in the Revascularization of Long Femoropopliteal Occlusive Lesions (TASC C and D): A Randomized Trial.,"BACKGROUND


Endovascular treatment has become the first-line revascularization technique for femoropopliteal lesions. This technique lacks reliable and accurate morphological control of the arterial segment treated. Intraoperative 2-dimensional angiogram consumes iodinated contrast media and increases X-ray exposure; this subsequently provides no 3-dimensional information on the quality of the revascularization completed, what could explain some of the early and late failures of the technique. We evaluated whether intraoperative optical coherence tomography (OCT) control in addition to standard angiogram could improve the primary patency rate at 12 months in comparison to standard angiogram alone in patients with occlusive femoropopliteal lesions.
METHODS


The tomography by optical coherence in femoral artery trial is a multicentric, prospective, randomized, controlled, and single-blind study including patients with long de novo occlusive femoropopliteal lesions. The randomization will be achieved in 2 balanced groups of patients after crossing successfully the lesion: group 1 with intraoperative OCT control in addition to standard angiogram and group 2 with standard angiogram alone. The randomization will be stratified by center. The protocol has been submitted and approved by a French ethic's committee under reference number CPP2019-12-098. The study has been registered under the reference number NCT04434586 on the Web site of clinicaltrials.gov.
RESULTS


The primary outcome of the study is the primary patency at 12 months. The number of patients who need to be treated is 166 (83 in each group) considering 5% of no workable data. Symptoms' improvement, target lesion revascularization, target vessel revascularization, quality-of-life questionnaires, cost utility, and cost effectiveness will be analyzed as secondary end-point variables at 12 months.
CONCLUSIONS


The present study is to evaluate the potential benefit for patients on the result of endovascular revascularization of long occlusive femoropopliteal lesion at 12 months when using intraoperative OCT control.",2020,"Symptoms' improvement, target lesion revascularisation, target vessel revascularisation, quality of life questionnaires, cost-utility and cost-effectiveness will be analysed as secondary endpoint variables at 12 months.
","['patients with long de novo occlusive femoropopliteal lesions', 'patients with occlusive femoropopliteal lesions', 'patients on the result of endovascular revascularisation of long occlusive femoro-popliteal lesion at 12-month when using intraoperative OCT control ']","['standard angiogram alone', 'OCT (optical coherence tomography) contribution assessment', 'intra-operative OCT control in addition to standard angiogram and group 2 with standard angiogram alone', 'intra-operative optical coherence tomography (OCT) control']","[""Symptoms' improvement, target lesion revascularisation, target vessel revascularisation, quality of life questionnaires, cost-utility and cost-effectiveness"", 'primary patency rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0442037', 'cui_str': 'Popliteal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}]",,0.0699652,"Symptoms' improvement, target lesion revascularisation, target vessel revascularisation, quality of life questionnaires, cost-utility and cost-effectiveness will be analysed as secondary endpoint variables at 12 months.
","[{'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dubosq', 'Affiliation': 'Department of Vascular Surgery, Institut Cœur-Poumon, CHU Lille, Lille, France.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Gouëffic', 'Affiliation': 'Vascular Center, Groupe Hospitalier Paris Saint Joseph, Paris, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Duhamel', 'Affiliation': 'Univ. Lille, CHU Lille, Metrics: Évaluation des Technologies de santé et des Pratiques Médicales, Lille, France.'}, {'ForeName': 'Fanette', 'Initials': 'F', 'LastName': 'Denies', 'Affiliation': 'Univ. Lille, CHU Lille, Metrics: Évaluation des Technologies de santé et des Pratiques Médicales, Lille, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Dervaux', 'Affiliation': 'Univ. Lille, CHU Lille, Metrics: Évaluation des Technologies de santé et des Pratiques Médicales, Lille, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Goyault', 'Affiliation': 'Department of Vascular and Oncological Interventional Radiology, Institut Cardiovasculaire de Strasbourg (ICS), Clinique Rhena, Strasbourg, France.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sobocinski', 'Affiliation': 'Department of Vascular Surgery, Institut Cœur-Poumon, CHU Lille, Lille, France. Electronic address: jonathan.sobocinski@univ-lille.fr.'}]",Annals of vascular surgery,['10.1016/j.avsg.2020.06.061']
1391,32635406,Modulation of Phenylalanine and Tyrosine Metabolism in HIV-1 Infected Patients with Neurocognitive Impairment: Results from a Clinical Trial.,"To investigate the effects of oral bacteriotherapy on intestinal phenylalanine and tyrosine metabolism, in this longitudinal, double-arm trial, 15 virally suppressed HIV+ individuals underwent blood and fecal sample collection at baseline and after 6 months of oral bacteriotherapy. A baseline fecal sample was collected from 15 healthy individuals and served as control group for the baseline levels of fecal phenylalanine and tyrosine. CD4 and CD8 immune activation (CD38 + ) was evaluated by flow cytometry. Amino acid evaluation on fecal samples was conducted by Proton Nuclear Magnetic Resonance. Results showed that HIV+ participants displayed higher baseline phenylalanine/tyrosine ratio values than healthy volunteers. A significand reduction in phenylalanine/tyrosine ratio and peripheral CD4 +  CD38 +  activation was observed at the end of oral bacteriotherapy. In conclusion, probiotics beneficially affect the immune activation of HIV+ individuals. Therefore, the restoration of intestinal amino acid metabolism could represent the mechanisms through which probiotics exert these desirable effects.",2020,A significand reduction in phenylalanine/tyrosine ratio and peripheral CD4 +  CD38 +  activation was observed at the end of oral bacteriotherapy.,"['HIV-1 Infected Patients with Neurocognitive Impairment', '15 virally suppressed HIV+ individuals underwent blood and fecal sample collection at baseline and after 6 months of oral bacteriotherapy', '15 healthy individuals and served as control group for the baseline levels of fecal phenylalanine and tyrosine']","['oral bacteriotherapy', 'Phenylalanine and Tyrosine Metabolism']","['baseline phenylalanine/tyrosine ratio values', 'phenylalanine/tyrosine ratio and peripheral CD4 +  CD38 +  activation', 'CD4 and CD8 immune activation (CD38 + ']","[{'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0200345', 'cui_str': 'Specimen collection'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0041485', 'cui_str': 'Tyrosine'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0041485', 'cui_str': 'Tyrosine'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0041485', 'cui_str': 'Tyrosine'}, {'cui': 'C1532109', 'cui_str': 'Ratio value'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0075742', 'cui_str': 'Lymphocyte antigen CD38'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0439662', 'cui_str': 'Immune'}]",15.0,0.0875068,A significand reduction in phenylalanine/tyrosine ratio and peripheral CD4 +  CD38 +  activation was observed at the end of oral bacteriotherapy.,"[{'ForeName': 'Giuseppe P', 'Initials': 'GP', 'LastName': 'Innocenti', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza, University of Rome, viale del Policlinico 155, 00161 Rome, Italy.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Santinelli', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza, University of Rome, viale del Policlinico 155, 00161 Rome, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Laghi', 'Affiliation': 'Department of Agro-Food Science and Technology, University of Bologna, Viale Fanin 46, 40127 Bologna, Italy.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Borrazzo', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza, University of Rome, viale del Policlinico 155, 00161 Rome, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pinacchio', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza, University of Rome, viale del Policlinico 155, 00161 Rome, Italy.'}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Fratino', 'Affiliation': 'Department of Neurology Sapienza, University of Rome, Piazzale Aldo Moro 5, 00185 Rome, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Celani', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza, University of Rome, viale del Policlinico 155, 00161 Rome, Italy.'}, {'ForeName': 'Eugenio N', 'Initials': 'EN', 'LastName': 'Cavallari', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza, University of Rome, viale del Policlinico 155, 00161 Rome, Italy.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Scagnolari', 'Affiliation': 'Laboratory of Virology, Department of Molecular Medicine, Affiliated to Istituto Pasteur Italia-Cenci Bolognetti Foundation, Sapienza, University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Frasca', 'Affiliation': 'Laboratory of Virology, Department of Molecular Medicine, Affiliated to Istituto Pasteur Italia-Cenci Bolognetti Foundation, Sapienza, University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Antonelli', 'Affiliation': 'Laboratory of Virology, Department of Molecular Medicine, Affiliated to Istituto Pasteur Italia-Cenci Bolognetti Foundation, Sapienza, University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Claudio M', 'Initials': 'CM', 'LastName': 'Mastroianni', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza, University of Rome, viale del Policlinico 155, 00161 Rome, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': ""d'Ettorre"", 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza, University of Rome, viale del Policlinico 155, 00161 Rome, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Ceccarelli', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza, University of Rome, viale del Policlinico 155, 00161 Rome, Italy.'}]",Metabolites,['10.3390/metabo10070274']
1392,32638172,Intravenous Migraine Treatment in Children and Adolescents.,"PURPOSE OF REVIEW


Pediatric migraine is a common, chronic, and disabling neurological disorder in children and adolescents. Outpatient management is not always effective, and intravenous migraine management may be necessary for headache treatment in the pediatric emergency department. Most current treatment is based on retrospective evidence and there is a lack of well-designed randomized double-blinded controlled pediatric studies. Intravenous drug treatment agents including intravenous fluids, prochlorperazine, diphenhydramine, metoclopramide, dexamethasone, magnesium, valproate and propofol, and dihydroergotamine are reviewed in this paper.
RECENT FINDINGS


Nineteen studies were reviewed including one prospective randomized double-blind; one single-blinded randomized; one prospective; and one open-label, randomized clinical trial. Most studies were retrospective and the quality of the studies was limited. No definite conclusions can be drawn from the studies, but appropriate prospective trials between major pediatric headache institutions will move pediatric intravenous migraine management forward.",2020,"No definite conclusions can be drawn from the studies, but appropriate prospective trials between major pediatric headache institutions will move pediatric intravenous migraine management forward.","['Children and Adolescents', 'children and adolescents', 'Nineteen studies']","['Intravenous Migraine', 'prochlorperazine, diphenhydramine, metoclopramide, dexamethasone, magnesium, valproate and propofol, and dihydroergotamine']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0033229', 'cui_str': 'Prochlorperazine'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0012291', 'cui_str': 'Dihydroergotamine'}]",[],19.0,0.131823,"No definite conclusions can be drawn from the studies, but appropriate prospective trials between major pediatric headache institutions will move pediatric intravenous migraine management forward.","[{'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Werner', 'Affiliation': 'Division of Pediatric Neurology, Duke University Medical Center, Durham, NC, USA. klaus.werner@duke.edu.'}, {'ForeName': 'Sharoon', 'Initials': 'S', 'LastName': 'Qaiser', 'Affiliation': ""Department of Neurology, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, E4-310, 3333 Burnet Avenue, Cincinnati, OH, 45229, USA.""}, {'ForeName': 'Marielle', 'Initials': 'M', 'LastName': 'Kabbouche', 'Affiliation': ""Department of Neurology, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, E4-310, 3333 Burnet Avenue, Cincinnati, OH, 45229, USA.""}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Murphy', 'Affiliation': 'Medical Center Library & Archives, Duke University Medical Center, Durham, NC, 27710, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Maconochie', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Hershey', 'Affiliation': ""Department of Neurology, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, E4-310, 3333 Burnet Avenue, Cincinnati, OH, 45229, USA.""}]",Current pain and headache reports,['10.1007/s11916-020-00867-7']
1393,32629403,Monomethyl fumarate has better gastrointestinal tolerability profile compared with dimethyl fumarate.,"BACKGROUND


Monomethyl fumarate (MMF) is the pharmacologically active metabolite of dimethyl fumarate (DMF). MMF formulated as Bafiertam™ 190 mg and DMF formulated as Tecfidera 240 mg deliver bioequivalent exposure of MMF and therefore possess the same efficacy/safety profiles. DMF is a widely used oral treatment for relapsing-remitting forms of multiple sclerosis (RRMS) but is limited in some patients, primarily female, by issues with gastrointestinal (GI) tolerability.
METHODS


This was a randomized, double-blind, head-to-head, 5-week study evaluating the GI tolerability of MMF 190 mg vs DMF 240 mg, administered twice daily in healthy subjects, using a derivative of the self-administered Modified Overall Gastrointestinal Symptom Scale (MOGISS). Subjects were stratified (3:1, female:male) and randomized (1:1) to the treatments. The primary endpoint was the Area Under the Curve (AUC) in each of the individual symptoms in the MOGISS over the 5-week treatment period. Other endpoints included the AUC over the 5-week treatment period in the MOGISS composite and total scores; duration and severity of GI events; Number and percentage of subjects reporting GI events during the overall treatment period, and assessment of safety/tolerability.
RESULTS


Inferential analysis of the hierarchical testing of overall treatment differences in each MOGISS symptom AUC occurred in a predefined sequence starting with Abdominal Pain. For each symptom, LSMean AUC values were lower for MMF than DMF, however, the first primary endpoint, Abdominal Pain, was not statistically different between treatments; thus, all subsequent statistical analyses were considered exploratory. The side effects and safety profiles observed were consistent with the known profiles of DMF, with no new or unique safety concerns noted.
CONCLUSIONS


Bafiertam showed an improved gastrointestinal tolerability profile compared with Tecfidera, with less severe GI events and fewer days of self-assessed GI symptoms, fewer GI adverse events, and lower discontinuation rates because of GI adverse events.",2020,"The side effects and safety profiles observed were consistent with the known profiles of DMF, with no new or unique safety concerns noted.
",['healthy subjects'],"['DMF', 'Monomethyl fumarate (MMF', 'MMF 190 mg vs DMF']","['LSMean AUC values', 'MOGISS composite and total scores; duration and severity of GI events; Number and percentage of subjects reporting GI events', 'gastrointestinal tolerability profile', 'derivative of the self-administered Modified Overall Gastrointestinal Symptom Scale (MOGISS', 'Area Under the Curve (AUC', 'safety/tolerability', 'Abdominal Pain', 'GI tolerability', 'severe GI events and fewer days of self-assessed GI symptoms, fewer GI adverse events']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0058218', 'cui_str': 'dimethyl fumarate'}, {'cui': 'C3848524', 'cui_str': 'monomethyl fumarate'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}, {'cui': 'C4517622', 'cui_str': '190'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0797155,"The side effects and safety profiles observed were consistent with the known profiles of DMF, with no new or unique safety concerns noted.
","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wynn', 'Affiliation': 'Consultants in Neurology, Ltd, Northbrook, IL 60062, USA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Lategan', 'Affiliation': 'Banner Life Sciences, 3890 Premier Dr., Suite 110, High Point, NC 27265, USA. Electronic address: Lategan@bannerls.com.'}, {'ForeName': 'Tiffany N', 'Initials': 'TN', 'LastName': 'Sprague', 'Affiliation': 'Banner Life Sciences, 3890 Premier Dr., Suite 110, High Point, NC 27265, USA.'}, {'ForeName': 'Franck S', 'Initials': 'FS', 'LastName': 'Rousseau', 'Affiliation': 'Banner Life Sciences, 3890 Premier Dr., Suite 110, High Point, NC 27265, USA.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Fox', 'Affiliation': 'Central Texas Neurology Consultants, Round Rock, TX 78681, USA.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102335']
1394,32631142,Mixed-effects models for the design and analysis of stepped wedge cluster randomized trials: An overview.,"The stepped wedge cluster randomized design has received increasing attention in pragmatic clinical trials and implementation science research. The key feature of the design is the unidirectional crossover of clusters from the control to intervention conditions on a staggered schedule, which induces confounding of the intervention effect by time. The stepped wedge design first appeared in the Gambia hepatitis study in the 1980s. However, the statistical model used for the design and analysis was not formally introduced until 2007 in an article by Hussey and Hughes. Since then, a variety of mixed-effects model extensions have been proposed for the design and analysis of these trials. In this article, we explore these extensions under a unified perspective. We provide a general model representation and regard various model extensions as alternative ways to characterize the secular trend, intervention effect, as well as sources of heterogeneity. We review the key model ingredients and clarify their implications for the design and analysis. The article serves as an entry point to the evolving statistical literatures on stepped wedge designs.",2020,"We provide a general model representation and regard various model extensions as alternative ways to characterize the secular trend, intervention effect, as well as sources of heterogeneity.",[],[],[],[],[],[],,0.0502379,"We provide a general model representation and regard various model extensions as alternative ways to characterize the secular trend, intervention effect, as well as sources of heterogeneity.","[{'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Hughes', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Hemming', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Melnick', 'Affiliation': 'Department of Emergency Medicine, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Washington, Seattle, WA, USA.'}]",Statistical methods in medical research,['10.1177/0962280220932962']
1395,32639241,The 11th Trial of a Cardiovascular Clinical Trialist: Coronavirus-2: Part 2.,,2020,,[],[],[],[],[],[],,0.0214642,,"[{'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Frishman', 'Affiliation': 'Department of Medicine, New York Medical College/Westchester Medical Center, Valhalla, NY.'}]",Cardiology in review,['10.1097/CRD.0000000000000328']
1396,32639280,Predictive and prognostic value of magnesium serum level in FOLFIRI plus cetuximab or bevacizumab treated patients with stage IV colorectal cancer: results from the FIRE-3 (AIO KRK-0306) study.,"Magnesium wasting is a frequent side effect of epidermal growth factor receptor (EGFR)-antibody treatment as magnesium-absorption mechanisms are dependent on EGFR signaling. EGFR-inhibition results in decreased renal reabsorption. There is evidence that hypomagnesemia during cetuximab treatment correlates with response. The prognostic role of hypomagnesemia during bevacizumab treatment has not been studied yet. Here, we evaluate the prognostic value of hypomagnesemia in patients with metastatic colorectal cancer treated with FOLFIRI plus cetuximab or bevacizumab as first-line therapy. A total of 391 of 752 patients of the firstline irinotecan study population had magnesium levels measured at baseline and for the first three cycles (6 weeks) of treatment. Of those, 240 had Rat Sarkoma wildtype tumors. Overall hypomagnesemia was more common in the cetuximab compared to the bevacizumab arm (80 vs. 43%, P < 0.005). During therapy, magnesium showed a time-dependent decrease to 80% of baseline in the cetuximab and to 89% in the bevacizumab arm. Whereas magnesium continued to decrease over time in the cetuximab-treated patients, it remained stable in the bevacizumab-treated. Overall response rate (ORR) was associated with higher magnesium at week 6 (20.9 vs. 79.1%, P = 0.041). Bevacizumab-treated patients with magnesium levels below the median value at week 6 had a significantly longer progression-free survival (PFS; 11.7 vs. 9.9 months, P = 0.034; hazard ratio 0.73) and a trend towards longer overall survival (OS) (29.6 vs. 23.2 months, P = 0.089; hazard ratio 0.77). Hypomagnesemia at predefined time points and magnesium nadir had no significant effect on ORR, OS and PFS in the cetuximab arm. Our data show different magnesium kinetics in patients with metastatic colorectal cancer treated with cetuximab or bevacizumab. For patients treated with cetuximab, hypomagnesemia did not have an impact on response and survival. Hypomagnesemia might have a prognostic value in bevacizumab treatment.",2020,"Hypomagnesemia at predefined time points and magnesium nadir had no significant effect on ORR, OS and PFS in the cetuximab arm.","['treated patients with stage IV colorectal cancer', 'A total of 391 of 752 patients of the firstline irinotecan study population had', 'patients with metastatic colorectal cancer treated with', '240 had Rat Sarkoma wildtype tumors']","['FOLFIRI plus cetuximab or bevacizumab', 'cetuximab or bevacizumab', 'bevacizumab', 'Bevacizumab']","['ORR, OS and PFS', 'Overall response rate (ORR', 'renal reabsorption', 'progression-free survival', 'overall survival (OS', 'hypomagnesemia', 'Hypomagnesemia', 'Overall hypomagnesemia', 'prognostic value of hypomagnesemia', 'response and survival', 'magnesium levels']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0677950', 'cui_str': 'Colorectal cancer stage IV'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2610986', 'cui_str': 'Renal Absorption'}, {'cui': 'C0151723', 'cui_str': 'Hypomagnesemia'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum'}]",,0.154894,"Hypomagnesemia at predefined time points and magnesium nadir had no significant effect on ORR, OS and PFS in the cetuximab arm.","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schulz', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU), Munich.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU), Munich.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Heinrich', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU), Munich.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Haas', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU), Munich.'}, {'ForeName': 'Julian W', 'Initials': 'JW', 'LastName': 'Holch', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU), Munich.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Fraccaroli', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU), Munich.'}, {'ForeName': 'Swantje', 'Initials': 'S', 'LastName': 'Held', 'Affiliation': 'ClinAssess GmbH, Leverkusen.'}, {'ForeName': 'Jobst C', 'Initials': 'JC', 'LastName': 'von Einem', 'Affiliation': 'Division of Hematology, Oncology and Tumor Immunology (CCM), Department of Medicine, Charité - Universitaetsmedizin Berlin, Berlin.'}, {'ForeName': 'Dominik P', 'Initials': 'DP', 'LastName': 'Modest', 'Affiliation': 'Division of Hematology, Oncology and Tumor Immunology (CCM), Department of Medicine, Charité - Universitaetsmedizin Berlin, Berlin.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Fischer von Weikersthal', 'Affiliation': 'Department of Hematology and Oncology, Gesundheitszentrum St. Marien, Amberg.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kullmann', 'Affiliation': 'Department of Medicine I, Klinikum Weiden, Weiden.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Moehler', 'Affiliation': 'Department of Medicine II, University Hospital, Johannes Gutenberg University Clinic Mainz, Mainz, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Scheithauer', 'Affiliation': 'Department of Internal Medicine I and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Jung', 'Affiliation': 'Institute of Pathology, University of Munich, Munich, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Stintzing', 'Affiliation': 'Division of Hematology, Oncology and Tumor Immunology (CCM), Department of Medicine, Charité - Universitaetsmedizin Berlin, Berlin.'}]",Anti-cancer drugs,['10.1097/CAD.0000000000000965']
1397,32634485,Virtual mind-body treatment for adolescents with neurofibromatosis: Study protocol for a single-blind randomized controlled trial.,"BACKGROUND


Neurofibromatoses (NF) are a group of genetically distinct disorders of the nervous system unified by the predisposition to nerve sheath tumors. Although adolescents with NF types 1 and 2 (NF1 and NF2) report poor quality of life and high psychosocial burden, there are no evidence-based interventions to address these needs. This paper presents the study design and protocol for the first randomized controlled trial (RCT) of a mind-body intervention for adolescents with NF, Resilient Youth with NF (RY-NF), versus an educational control group, Health Education for NF (HE-NF), both delivered in groups via secure live video.
METHODS


This is an ongoing, single-blind efficacy RCT. Recruitment began in November 2019 and will continue until March 2022. We will enroll 200 English-speaking, geographically diverse adolescents (ages 12-17) with NF1 and NF2 who report significant distress or difficulty coping with their NF symptoms. We will use a shared-baseline, linear mixed model to compare the effect of RY-NF versus HE-NF on changes in quality of life (QoL) and psychosocial outcomes from baseline to post-intervention, and 6- and 12-month follow-ups. We will also develop NF-specific minimal clinically important difference (MCID) for QoL variables, and conduct mediation and moderation analyses to understand mechanisms of improvement.
DISCUSSION


This study has important clinical and public health implications for the psychosocial functioning of adolescents with NF. It provides a model for efficient delivery of virtual psychosocial care for adolescents with rare diseases. Plans for dissemination and implementation of the RY-NF should efficacy be ascertained are also discussed.",2020,"Although adolescents with NF types 1 and 2 (NF1 and NF2) report poor quality of life and high psychosocial burden, there are no evidence-based interventions to address these needs.","['adolescents with NF, Resilient Youth with NF (RY-NF', 'adolescents with neurofibromatosis', 'adolescents with NF', 'adolescents with rare diseases', '200 English-speaking, geographically diverse adolescents (ages 12-17) with NF1 and NF2 who report significant distress or difficulty coping with their NF symptoms']","['educational control group, Health Education for NF (HE-NF', 'Virtual mind-body treatment', 'mind-body intervention', 'RY-NF versus HE-NF']",['quality of life (QoL) and psychosocial outcomes'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0027831', 'cui_str': 'Neurofibromatosis type 1'}, {'cui': 'C0678236', 'cui_str': 'Rare Diseases'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027832', 'cui_str': 'Neurofibromatosis type 2'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0582154', 'cui_str': 'Difficulty coping'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1513305', 'cui_str': 'Mind-Body Medicine'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0666435,"Although adolescents with NF types 1 and 2 (NF1 and NF2) report poor quality of life and high psychosocial burden, there are no evidence-based interventions to address these needs.","[{'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Reichman', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Psychiatry Department, Massachusetts General Hospital, One Bowdoin, Square, 1st floor Boston, 02114 Boston, MA, United States of America. Electronic address: mreichman@mgh.harvard.edu.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Riklin', 'Affiliation': 'Department of Psychology, Fordham University, Dealy 336, 441 East Fordham Rd, Bronx, NY 10458, United States of America. Electronic address: eriklin@fordham.edu.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Macklin', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital, 50 Staniford Street, St 560, Boston, MA 02114, United States of America. Electronic address: emacklin@mgh.harvard.edu.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Vranceanu', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Psychiatry Department, Massachusetts General Hospital, One Bowdoin, Square, 1st floor Boston, 02114 Boston, MA, United States of America; Harvard Medical School, One Bowdoin Square, 1st floor Boston, 02114 Boston, MA, United States of America. Electronic address: avranceanu@mgh.harvard.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106078']
1398,32634745,"Examining sex, adverse childhood experiences, and oxytocin on neuroendocrine reactivity in smokers.","Adverse childhood experiences (ACE) are associated with greater neuroendocrine responses to social stress in substance users. The neuropeptide oxytocin might attenuate this relationship. Given sex differences in ACE exposure and neuroendocrine stress reactivity, it is unknown whether this association is similar for males and females. Therefore, this secondary analysis evaluated the interactive effect of sex, ACE, and acute oxytocin administration on neuroendocrine stress responses in adult cigarette smokers (N = 144). Participants completed the Adverse Childhood Experiences Questionnaire at screening and were randomized to receive intranasal oxytocin or placebo before undergoing the Trier Social Stress Task (TSST). Cortisol levels were assessed at pre- and post-medication administration and at 20 and 40 min following the TSST. Generalized linear mixed models were developed to predict post-TSST cortisol levels. Predictors included treatment assignment (placebo vs. oxytocin), sex (male vs. female), ACE (0-10 total score), pre-medication cortisol levels, and minutes since medication administration. The hypothesized three-way interaction between sex, oxytocin, and ACE scores was significant. Linear associations between ACE scores and cortisol reactivity indicated higher ACE scores were associated with attenuated cortisol response in females, regardless of treatment condition. For males, higher ACE scores were associated with heightened cortisol response, an effect that was attenuated by oxytocin. Results indicate that the association between ACE and neuroendocrine reactivity to social stress, as well as the attenuating effect of oxytocin, is differentially impacted by sex. Males with greater childhood adversity may be more likely to benefit from oxytocin's anxiolytic properties.",2020,"For males, higher ACE scores were associated with heightened cortisol response, an effect that was attenuated by oxytocin.","['adult cigarette smokers (N\u2009=\u2009144', 'smokers', 'Participants completed the Adverse Childhood Experiences Questionnaire at screening']","['oxytocin', 'treatment assignment (placebo vs. oxytocin', 'neuropeptide oxytocin', 'intranasal oxytocin or placebo', 'oxytocin administration']","['sex (male vs. female), ACE (0-10 total score), pre-medication cortisol levels, and minutes since medication administration', 'cortisol response', 'ACE scores', 'Cortisol levels', 'ACE scores and cortisol reactivity indicated higher ACE scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4284014', 'cui_str': 'Adverse Childhood Experience questionnaire'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4296616', 'cui_str': 'Adverse Childhood Experiences'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0291417,"For males, higher ACE scores were associated with heightened cortisol response, an effect that was attenuated by oxytocin.","[{'ForeName': 'Caitlyn O', 'Initials': 'CO', 'LastName': 'Hood', 'Affiliation': 'Department of Psychology, College of Arts & Sciences, University of Kentucky, United States. Electronic address: caitlyn.hood@uky.edu.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Tomko', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Department of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Breanna M', 'Initials': 'BM', 'LastName': 'Tuck', 'Affiliation': 'Steve Hicks School of Social Work, University of Texas at Austin, United States.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States; Ralph H. Johnson VA Medical Center, United States.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Saladin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, United States; Department of Health Sciences and Research, College of Health Professions, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'McClure', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104752']
1399,32634760,Effect of dose-dense adjuvant chemotherapy in hormone receptor positive/HER2-negative early breast cancer patients according to immunohistochemically defined luminal subtype: an exploratory analysis of the GIM2 trial.,"BACKGROUND


Luminal A-like and luminal B-like subtypes have different sensitivity to (neo)adjuvant chemotherapy, but their role in predicting dose-dense (DD) efficacy in the high-risk setting is unknown. In this exploratory analysis of the Gruppo Italiano Mammella 2 (GIM2) trial, we investigated DD efficacy according to luminal-like subtypes.
METHODS


Patients with node-positive early breast cancer were randomised to receive either DD or standard-interval (SI) anthracycline-based chemotherapy followed by paclitaxel. In our analysis, luminal A-like cohort was identified as having a Ki67 < 20% and a progesterone receptor (PgR) ≥ 20%; luminal B-like cohort as having a Ki67 ≥ 20% and/or a PgR < 20%.
RESULTS


Out of 2003 patients enrolled in the GIM2 trial, 412 had luminal A-like and 638 luminal B-like breast cancer. After a median follow-up of 7.9 years, disease-free survival (DFS) was 80.8% (95% confidence interval [CI] 76.4-84.5) and 70.5% (66.5-74.2) in luminal A-like and luminal B-like cohorts; overall survival (OS) was 91.6% (88.2-94.1) and 85.1% (81.7-87.9), respectively. We found no significant interaction between treatment and luminal subtype (interaction p = 0.603 and 0.535 for DFS and OS, respectively). When DD efficacy was investigated separately in each cohort, luminal-B like cohort appeared to benefit more from the DD schedule both in terms of DFS (unadjusted hazard ratio [HR] 0.72 [95% CI 0.54-0.96]) and OS (unadjusted HR 0.61 [95% CI 0.40-0.94]), compared with the luminal A-like cohort (unadjusted HR for DFS 0.89 [95% CI 0.59-1.33]; unadjusted HR for OS 0.83 [95% CI 0.45-1.54]).
CONCLUSIONS


No significant interaction between luminal-like subtype and treatment was observed. Patients in the luminal B-like cohort seemed to benefit more from DD schedule.",2020,"We found no significant interaction between treatment and luminal subtype (interaction p = 0.603 and 0.535 for DFS and OS, respectively).","['2003 patients enrolled in the GIM2 trial, 412 had luminal A-like and 638 luminal B-like breast cancer', 'Patients with node-positive early breast cancer', 'hormone receptor positive/HER2-negative early breast cancer patients according to immunohistochemically defined luminal subtype']","['DD or standard-interval (SI) anthracycline-based chemotherapy followed by paclitaxel', 'progesterone receptor (PgR', 'dose-dense adjuvant chemotherapy']","['overall survival (OS', 'disease-free survival (DFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0034833', 'cui_str': 'Progesterone receptor'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",2003.0,0.206045,"We found no significant interaction between treatment and luminal subtype (interaction p = 0.603 and 0.535 for DFS and OS, respectively).","[{'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Conte', 'Affiliation': 'Medical Oncology Unit 2, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genoa, GE, Italy; Translational Genomics and Targeted Therapeutics in Solid Tumors, August Pi i Sunyer Biomedical Research Institute, Carrer de Rosselló, 149, 08036, Barcelona, Spain.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Bruzzone', 'Affiliation': 'Clinical Epidemiology Unit, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genoa, GE, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Lambertini', 'Affiliation': 'Medical Oncology Department, UOC Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 1632, Genoa, GE, Italy; Department of Internal Medicine and Medical Specialties (DiMI), School of Medicine, University of Genova, Viale Benedetto XV, 10, 16132, Genoa, GE, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Poggio', 'Affiliation': 'Medical Oncology Unit 2, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genoa, GE, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Bighin', 'Affiliation': 'Medical Oncology Unit 2, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genoa, GE, Italy.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Blondeaux', 'Affiliation': 'Medical Oncology Unit 2, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genoa, GE, Italy.'}, {'ForeName': 'Michelino', 'Initials': 'M', 'LastName': 'De Laurentiis', 'Affiliation': 'Breast Unit, Istituto Nazionale Tumori-Fondazione ""G. Pascale"", Via Mariano Semmola, 53, 80131, Naples, NA, Italy.'}, {'ForeName': 'Enrichetta', 'Initials': 'E', 'LastName': 'Valle', 'Affiliation': 'Department of Medical Oncology, Ospedale Businco, Via Edward Jenner, 1, 09121, Cagliari, CA, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cognetti', 'Affiliation': 'Department of Clinical and Molecolar Medicine, La Sapienza University, Viale Regina Elena, 324, 00161, Rome, RM, Italy.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Nisticò', 'Affiliation': 'Department of Medical Oncology 1, Istituto Nazionale Tumori ""Regina Elena"", Via Elio Chianesi, 53, 00128, Rome, RM, Italy.'}, {'ForeName': 'Sabino', 'Initials': 'S', 'LastName': 'De Placido', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Sergio Pansini, 5, 80131, Naples, NA, Italy.'}, {'ForeName': 'Ornella', 'Initials': 'O', 'LastName': 'Garrone', 'Affiliation': 'Breast Unit, Department of Oncology, Azienda Ospedaliera Santa Croce e Carle, Via Michele Coppino, 26, 12100, Cuneo, CN, Italy.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gamucci', 'Affiliation': 'Department of Medical Oncology, Ospedale Sandro Pertini, Via dei Monti Tiburtini, 385/389, 00157, Rome, RM, Italy; Department of Medical Oncology, Ospedale SS Trinità, Località San Marciano, 03039, Sora, FR, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Montemurro', 'Affiliation': 'Multidisciplinary Oncology Outpatient Clinic, Candiolo Cancer Institute, FPO-IRCCS, Strada Provinciale, 142, 10060, Turin, TO, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Puglisi', 'Affiliation': 'Department of Medicine, University of Udine, Piazzale Massimiliano Kolbe, 4, 33100, Udine, Italy; Department of Medical Oncology, IRCCS Centro di Riferimento Oncologico Aviano - National Cancer Institute, Via Franco Gallini, 2, 33081, Aviano, PN, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Cardinali', 'Affiliation': 'Breast Unit, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genoa, GE, Italy.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Fregatti', 'Affiliation': 'Department of Surgical Sciences and Integrated Diagnostic (DISC), University of Genova, Viale Benedetto XV, 6, 1612, Genoa, GE, Italy; Department of Surgery, IRCCS Policlinico San Martino, Largo Rosanna Benzi 10, 1632, Genoa, GE, Italy.'}, {'ForeName': 'Loredana', 'Initials': 'L', 'LastName': 'Miglietta', 'Affiliation': 'Medical Oncology Unit 2, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genoa, GE, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Boccardo', 'Affiliation': 'Medical Oncology Department, UOC Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 1632, Genoa, GE, Italy; Department of Internal Medicine and Medical Specialties (DiMI), School of Medicine, University of Genova, Viale Benedetto XV, 10, 16132, Genoa, GE, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Ceppi', 'Affiliation': 'Clinical Epidemiology Unit, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genoa, GE, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Del Mastro', 'Affiliation': 'Department of Internal Medicine and Medical Specialties (DiMI), School of Medicine, University of Genova, Viale Benedetto XV, 10, 16132, Genoa, GE, Italy; Breast Unit, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genoa, GE, Italy. Electronic address: lucia.delmastro@hsanmartino.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.05.007']
1400,32640130,Phase 1-2 Trial of Antisense Oligonucleotide Tofersen for  SOD1  ALS.,"BACKGROUND


Tofersen is an antisense oligonucleotide that mediates the degradation of superoxide dismutase 1 (SOD1) messenger RNA to reduce SOD1 protein synthesis. Intrathecal administration of tofersen is being studied for the treatment of amyotrophic lateral sclerosis (ALS) due to  SOD1  mutations.
METHODS


We conducted a phase 1-2 ascending-dose trial evaluating tofersen in adults with ALS due to  SOD1  mutations. In each dose cohort (20, 40, 60, or 100 mg), participants were randomly assigned in a 3:1 ratio to receive five doses of tofersen or placebo, administered intrathecally for 12 weeks. The primary outcomes were safety and pharmacokinetics. The secondary outcome was the change from baseline in the cerebrospinal fluid (CSF) SOD1 concentration at day 85. Clinical function and vital capacity were measured.
RESULTS


A total of 50 participants underwent randomization and were included in the analyses; 48 participants received all five planned doses. Lumbar puncture-related adverse events were observed in most participants. Elevations in CSF white-cell count and protein were reported as adverse events in 4 and 5 participants, respectively, who received tofersen. Among participants who received tofersen, one died from pulmonary embolus on day 137, and one from respiratory failure on day 152; one participant in the placebo group died from respiratory failure on day 52. The difference at day 85 in the change from baseline in the CSF SOD1 concentration between the tofersen groups and the placebo group was 2 percentage points (95% confidence interval [CI], -18 to 27) for the 20-mg dose, -25 percentage points (95% CI, -40 to -5) for the 40-mg dose, -19 percentage points (95% CI, -35 to 2) for the 60-mg dose, and -33 percentage points (95% CI, -47 to -16) for the 100-mg dose.
CONCLUSIONS


In adults with ALS due to  SOD1  mutations, CSF SOD1 concentrations decreased at the highest concentration of tofersen administered intrathecally over a period of 12 weeks. CSF pleocytosis occurred in some participants receiving tofersen. Lumbar puncture-related adverse events were observed in most participants. (Funded by Biogen; ClinicalTrials.gov number, NCT02623699; EudraCT number, 2015-004098-33.).",2020,"In adults with ALS due to  SOD1  mutations, CSF SOD1 concentrations decreased at the highest concentration of tofersen administered intrathecally over a period of 12 weeks.","['50 participants underwent randomization and were included in the analyses; 48 participants', 'participants who received tofersen, one died from pulmonary embolus on day 137, and one from respiratory failure on day 152; one participant in the', 'adults with ALS due to  SOD1  mutations']","['tofersen or placebo', 'placebo']","['Clinical function and vital capacity', 'safety and pharmacokinetics', 'cerebrospinal fluid (CSF) SOD1 concentration', 'CSF pleocytosis', 'Lumbar puncture-related adverse events', 'CSF SOD1 concentrations', 'CSF SOD1 concentration']","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0669516', 'cui_str': 'Superoxide Dismutase 1'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0422813', 'cui_str': 'Clinical function'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0669516', 'cui_str': 'Superoxide Dismutase 1'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0151857', 'cui_str': 'Pleocytosis'}, {'cui': 'C0037943', 'cui_str': 'Lumbar puncture'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",50.0,0.595845,"In adults with ALS due to  SOD1  mutations, CSF SOD1 concentrations decreased at the highest concentration of tofersen administered intrathecally over a period of 12 weeks.","[{'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Miller', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Merit', 'Initials': 'M', 'LastName': 'Cudkowicz', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Shaw', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Andersen', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Nazem', 'Initials': 'N', 'LastName': 'Atassi', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Bucelli', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Genge', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Glass', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Shafeeq', 'Initials': 'S', 'LastName': 'Ladha', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Albert L', 'Initials': 'AL', 'LastName': 'Ludolph', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Maragakis', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'McDermott', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Pestronk', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ravits', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Salachas', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Trudell', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Van Damme', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Lorne', 'Initials': 'L', 'LastName': 'Zinman', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'C Frank', 'Initials': 'CF', 'LastName': 'Bennett', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Lane', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Sandrock', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Runz', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Graham', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Houshyar', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'McCampbell', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Nestorov', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Ih', 'Initials': 'I', 'LastName': 'Chang', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Manjit', 'Initials': 'M', 'LastName': 'McNeill', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Fanning', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Fradette', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Toby A', 'Initials': 'TA', 'LastName': 'Ferguson', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}]",The New England journal of medicine,['10.1056/NEJMoa2003715']
1401,32660010,"The Effect of  Lactobacillus acidophilus  YT1 (MENOLACTO) on Improving Menopausal Symptoms: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial.","This study evaluated the efficacy of  Lactobacillus acidophilus  YT1 (MENOLACTO) for alleviating menopausal symptoms. This study was a multi-center, randomized, double-blinded, placebo-controlled clinical trial involving female subjects (ages: 40-60 years) with menopausal symptoms and a Kupperman index (KMI) score ≥ 20. Subjects were administered 1 × 10 8  CFU/day MENOLACTO or placebo, with the primary endpoint being total KMI score, and the effect of secondary endpoints on alleviating menopausal symptoms according to individual categories of the modified KMI, as well as a quality of life questionnaire (MENQOL questionnaire). After 12 weeks, total KMI scores decreased significantly, demonstrating improved menopausal symptoms relative to placebo along with improved modified KMI scores. Additionally, quality of life, according to the MENQOL questionnaire, significantly improved in all four symptoms-physical, psychosocial, vasomotor, and sexual symptoms. Moreover, we observed no significant difference between the two groups or significant changes in blood follicle-stimulating hormone and estradiol levels or endometrial thickness. These results demonstrated that MENOLACTO alleviated menopausal symptoms without notable side effects and improved quality of life, suggesting its efficacy as an alternative supplement to alleviate menopausal symptoms in women ineligible for hormonal therapy.",2020,"Moreover, we observed no significant difference between the two groups or significant changes in blood follicle-stimulating hormone and estradiol levels or endometrial thickness.",['female subjects (ages: 40-60 years) with menopausal symptoms and a Kupperman index (KMI) score ≥ 20'],"['Lactobacillus acidophilus  YT1 (MENOLACTO', 'Placebo', 'placebo']","['quality of life', 'quality of life, according to the MENQOL questionnaire', 'alleviating menopausal symptoms according to individual categories of the modified KMI, as well as a quality of life questionnaire (MENQOL questionnaire', 'Menopausal Symptoms', 'total KMI scores', 'blood follicle-stimulating hormone and estradiol levels or endometrial thickness', 'symptoms-physical, psychosocial, vasomotor, and sexual symptoms', 'total KMI score']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0857249', 'cui_str': 'Blood follicle stimulating hormone'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0425722', 'cui_str': 'Sexual symptom'}]",,0.446017,"Moreover, we observed no significant difference between the two groups or significant changes in blood follicle-stimulating hormone and estradiol levels or endometrial thickness.","[{'ForeName': 'Eun Yeong', 'Initials': 'EY', 'LastName': 'Lim', 'Affiliation': 'Division of Food Functionality Research, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'So-Young', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Division of Food Functionality Research, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'Hee Soon', 'Initials': 'HS', 'LastName': 'Shin', 'Affiliation': 'Division of Food Functionality Research, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'Jaekwang', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Division of Food Functionality Research, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'Young-Do', 'Initials': 'YD', 'LastName': 'Nam', 'Affiliation': 'Division of Food Functionality Research, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'Dong Ock', 'Initials': 'DO', 'LastName': 'Lee', 'Affiliation': 'Center for Gynecologic Cancer, National Cancer Center Korea, Goyang-si 10408, Korea.'}, {'ForeName': 'Ji Young', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynecology, Konkuk University Hospital, Konkuk University School of Medicine, Seoul 05030, Korea.'}, {'ForeName': 'Sung Hum', 'Initials': 'SH', 'LastName': 'Yeon', 'Affiliation': 'R&D Center, Huons Co., Ltd., Ansan 15588, Korea.'}, {'ForeName': 'Rak Ho', 'Initials': 'RH', 'LastName': 'Son', 'Affiliation': 'R&D Center, Huons Co., Ltd., Ansan 15588, Korea.'}, {'ForeName': 'Chae Lee', 'Initials': 'CL', 'LastName': 'Park', 'Affiliation': 'R&D Center, Huons Co., Ltd., Ansan 15588, Korea.'}, {'ForeName': 'Yun Haeng', 'Initials': 'YH', 'LastName': 'Heo', 'Affiliation': 'Clinical Operation Team, Huons Co., Ltd., Seongnam-si 13486, Korea.'}, {'ForeName': 'Yun Tai', 'Initials': 'YT', 'LastName': 'Kim', 'Affiliation': 'Division of Food Functionality Research, Korea Food Research Institute, Wanju 55365, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9072173']
1402,32639645,"Effects of thoracic nerve block on perioperative lung injury, immune function, and recovery after thoracic surgery.","BACKGROUND


To investigate the effects of thoracic nerve block on perioperative lung injury, immune function, and recovery after thoracic surgery METHODS: A total of 120 patients with lung cancer were randomly allocated into three groups: general anesthesia group (GAL group), thoracic paravertebral nerve block (TPVB) combined with general anesthesia (TPL group), and TPVB (with paravertebral dexmedetomidine) combined with general anesthesia group (TDL group); 120 patients with esophageal cancer were randomly allocated into three groups: general anesthesia group (GAE group), TPVB combined with general anesthesia group (TPE group), and thoracic epidural block combined with general anesthesia group (TEE group). Lung injury and immune function were evaluated. Hemodynamic changes, early recovery in post-anesthesia care unit, pain, 6-min walking test (6MWT), drug consumption, and life quality were also observed. The duration in the PACU of patients was retrospectively analyzed. The effect of dexmedetomidine on lung injury was established in vitro.
RESULTS


The lung injury, including injury scores, apoptosis, and inflammation, were decreased in the TDL group compared with the GAL group and TPL group. The ratio of CD4 +  /CD8 +  cells at the end of surgery was higher in the TPE group than in the GAE group. More stable hemodynamic was found in TPL group and TPE group. Acute pain was alleviated and the 6MWT was enhanced by TPVB with or without dexmedetomidine. Anesthetic consumption was decreased by thoracic nerve block.
CONCLUSIONS


Thoracic nerve block, especially TPVB with or without paravertebral dexmedetomidine, can enhance recovery after thoracic surgery. Protection against independent lung injury and cellular immune dysfunction may be a potential mechanism.",2020,Acute pain was alleviated and the 6MWT was enhanced by TPVB with or without dexmedetomidine.,"['group); 120 patients with esophageal cancer', '120 patients with lung cancer']","['TPL', 'Thoracic nerve block, especially TPVB with or without paravertebral dexmedetomidine', 'TPE', 'general anesthesia group (GAL group), thoracic paravertebral nerve block (TPVB) combined with general anesthesia (TPL group), and TPVB (with paravertebral dexmedetomidine) combined with general anesthesia group (TDL', 'thoracic nerve block', 'GAL', 'dexmedetomidine', 'general anesthesia group (GAE group), TPVB combined with general anesthesia group (TPE group), and thoracic epidural block combined with general anesthesia group (TEE group']","['lung injury, including injury scores, apoptosis, and inflammation', 'Hemodynamic changes, early recovery in post-anesthesia care unit, pain, 6-min walking test (6MWT), drug consumption, and life quality', 'Anesthetic consumption', 'Lung injury and immune function', 'Acute pain', 'ratio of CD4 +  /CD8 +  cells', 'perioperative lung injury, immune function, and recovery']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]","[{'cui': 'C0039983', 'cui_str': 'Structure of thoracic spinal nerve'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0198806', 'cui_str': 'Paravertebral anesthesia'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0060993', 'cui_str': 'Galanin'}, {'cui': 'C0394835', 'cui_str': 'Local anesthetic thoracic epidural block'}]","[{'cui': 'C0273115', 'cui_str': 'Injury of lung'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]",120.0,0.0497344,Acute pain was alleviated and the 6MWT was enhanced by TPVB with or without dexmedetomidine.,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Center for Clinical Single Cell Biomedicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan, P. R. China.""}, {'ForeName': 'Xuhui', 'Initials': 'X', 'LastName': 'Cong', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Center for Clinical Single Cell Biomedicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan, P. R. China.""}, {'ForeName': 'Liyuan', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Center for Clinical Single Cell Biomedicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan, P. R. China.""}, {'ForeName': 'Mingyang', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Center for Clinical Single Cell Biomedicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan, P. R. China.""}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Center for Clinical Single Cell Biomedicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan, P. R. China.""}, {'ForeName': 'Hongfang', 'Initials': 'H', 'LastName': 'Geng', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Center for Clinical Single Cell Biomedicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan, P. R. China.""}, {'ForeName': 'Jianqin', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': ""Department of General Medicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan, P. R. China.""}, {'ForeName': 'Jiaqiang', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Center for Clinical Single Cell Biomedicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan, P. R. China.""}]",Clinical and translational medicine,['10.1002/ctm2.38']
1403,32639688,Evaluation of the recovery outcome of poststroke cognitive impairment after cluster needling of scalp acupuncture therapy based on functional near-infrared spectroscopy.,"BACKGROUND


Cognitive impairment often arises in patients suffered from stroke. Acupuncture is a recommended treatment option for stroke by the World Health Organization (WHO) and has been shown to improve the cognitive function of patients with poststroke cognitive impairment (PSCI).
METHODS


In the present study, we assessed the efficacy of scalp acupuncture with cluster needling on PSCI patients. Fifty six PSCI patients were randomly separated into the reference group who received drug treatment only and the treatment group who received cluster needling of scalp acupuncture on top of drug treatment. Cognitive function was compared between the two groups before and after treatment. We also took the advantage of functional near-infrared spectroscopy to assess the cerebral hemoglobin levels.
RESULTS


We reveal that applying cluster needling of scalp acupuncture on top of drug treatment can significantly improve the cognitive function and elevate the cerebral hemoglobin levels compared to patients treated with drug only.
CONCLUSIONS


Our results suggest that cluster needling of scalp acupuncture is an effective treatment against PSCI and shed light on its application on other neurological disorders.",2020,Cognitive function was compared between the two groups before and after treatment.,"['patients suffered from stroke', 'PSCI patients', 'patients with poststroke cognitive impairment (PSCI', 'Fifty six PSCI patients']","['scalp acupuncture', 'scalp acupuncture with cluster needling', 'Acupuncture', 'scalp acupuncture therapy', 'cluster needling of scalp acupuncture']","['Cognitive function', 'cognitive function', 'cerebral hemoglobin levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}]",56.0,0.0410108,Cognitive function was compared between the two groups before and after treatment.,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': 'The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Jingge', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'Heilongjiang University of Traditional Chinese Medicine, Harbin, China.'}]",Brain and behavior,['10.1002/brb3.1731']
1404,32635585,Effect of Non-Surgical Periodontal Treatment on Oxidative Stress Markers in Leukocytes and Their Interaction with the Endothelium in Obese Subjects with Periodontitis: A Pilot Study.,"AIM


The primary objective of this pilot study was to evaluate the effect of non-surgical periodontal treatment. The secondary aim was to evaluate the effect of dietary therapy on both parameters of oxidative stress in leukocytes and leukocyte-endothelial cell interactions in an obese population.
METHODS


This was a pilot study with a before-and-after design. Forty-nine obese subjects with periodontitis were randomized by means of the minimization method and assigned to one of two groups, one of which underwent dietary therapy while the other did not. All the subjects underwent non-surgical periodontal treatment. We determined periodontal, inflammatory and oxidative stress parameters-total reactive oxygen species (ROS), superoxide production, intracellular Ca 2+ , mitochondrial membrane potential and superoxide dismutase (SOD) activity. We also evaluated interactions between leukocytes and endothelium cells-velocity, rolling flux and adhesion-at baseline and 12 weeks after intervention.
RESULTS


Periodontal treatment improved the periodontal health of all the patients, with a reduction in serum retinol-binding protein 4 (RBP4), total superoxide production and cytosolic Ca 2+  in leukocytes. In the patients undergoing dietary therapy, there were less leukocyte adhesion to the endothelium, an effect that was accompanied by a decrease in TNFα, P-selectin and total ROS and an increase in SOD activity.
CONCLUSIONS


Whereas non-surgical periodontal treatment induces an improvement in leukocyte homeostasis, dietary therapy as an adjuvant reduces systemic inflammation and increases antioxidant status which, in turn, modulates leukocyte-endothelium dynamics.",2020,"RESULTS


Periodontal treatment improved the periodontal health of all the patients, with a reduction in serum retinol-binding protein 4 (RBP4), total superoxide production and cytosolic Ca 2+  in leukocytes.","['obese population', 'Obese Subjects with Periodontitis', 'Forty-nine obese subjects with periodontitis']","['Surgical Periodontal Treatment', 'dietary therapy']","['periodontal, inflammatory and oxidative stress parameters-total reactive oxygen species (ROS), superoxide production, intracellular Ca 2+ , mitochondrial membrane potential and superoxide dismutase (SOD) activity', 'TNFα, P-selectin and total ROS', 'SOD activity', 'leukocytes and endothelium cells-velocity, rolling flux and adhesion', 'serum retinol-binding protein 4 (RBP4), total superoxide production and cytosolic Ca 2+  in leukocytes', 'periodontal health', 'leukocyte adhesion', 'leukocyte homeostasis']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0162772', 'cui_str': 'Oxygen Species, Reactive'}, {'cui': 'C0038836', 'cui_str': 'Superoxide'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0596235', 'cui_str': 'Calcium ion'}, {'cui': 'C1720920', 'cui_str': 'Mitochondrial Membrane Potential'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1438309', 'cui_str': 'RBP4 protein, human'}, {'cui': 'C1383501', 'cui_str': 'Cytoplasmic matrix'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}]",49.0,0.0293666,"RESULTS


Periodontal treatment improved the periodontal health of all the patients, with a reduction in serum retinol-binding protein 4 (RBP4), total superoxide production and cytosolic Ca 2+  in leukocytes.","[{'ForeName': 'Mayte', 'Initials': 'M', 'LastName': 'Martínez-Herrera', 'Affiliation': 'Department of Stomatology, University of Valencia, Gascó i Oliag 1, 46010 Valencia, Spain.'}, {'ForeName': 'Zaida', 'Initials': 'Z', 'LastName': 'Abad-Jiménez', 'Affiliation': 'Department of Endocrinology and Nutrition, University Hospital Doctor Peset-FISABIO, Av. Gaspar Aguilar 90, 46017 Valencia, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Silvestre', 'Affiliation': 'Department of Stomatology, University of Valencia, Gascó i Oliag 1, 46010 Valencia, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'López-Domènech', 'Affiliation': 'Department of Endocrinology and Nutrition, University Hospital Doctor Peset-FISABIO, Av. Gaspar Aguilar 90, 46017 Valencia, Spain.'}, {'ForeName': 'Cecilia Fabiana', 'Initials': 'CF', 'LastName': 'Márquez-Arrico', 'Affiliation': 'Department of Stomatology, University of Valencia, Gascó i Oliag 1, 46010 Valencia, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Silvestre-Rangil', 'Affiliation': 'Department of Stomatology, University Hospital Doctor Peset-FISABIO, Av. Gaspar Aguilar 90, 46017 Valencia, Spain.'}, {'ForeName': 'Víctor M', 'Initials': 'VM', 'LastName': 'Víctor', 'Affiliation': 'Department of Endocrinology and Nutrition, University Hospital Doctor Peset-FISABIO, Av. Gaspar Aguilar 90, 46017 Valencia, Spain.'}, {'ForeName': 'Milagros', 'Initials': 'M', 'LastName': 'Rocha', 'Affiliation': 'Department of Endocrinology and Nutrition, University Hospital Doctor Peset-FISABIO, Av. Gaspar Aguilar 90, 46017 Valencia, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9072117']
1405,32643857,Impact of microvascular disease on cardiovascular outcomes in type 2 diabetes: Results from the LEADER and SUSTAIN 6 clinical trials.,"The randomized, double-blind, cardiovascular outcomes trials LEADER (NCT01179048) and SUSTAIN 6 (NCT01720446) showed cardiovascular risk reduction in patients with type 2 diabetes treated with liraglutide and semaglutide, respectively, compared with placebo. This post hoc analysis examined the impact of microvascular disease at baseline on cardiovascular outcomes in these trials, and the efficacy of liraglutide (1.8 mg) and once-weekly semaglutide (0.5-1.0 mg) in patients with and without microvascular disease. In total, 9340 patients from LEADER and 3297 patients from SUSTAIN 6 were included in this analysis; of these, 5761 and 2356 had a history of microvascular disease at baseline and 3835 and 1640 had a history of both microvascular and macrovascular disease, respectively. Patients with microvascular disease were shown to have an increased risk of major adverse cardiovascular events compared with patients without microvascular disease (hazard ratio [95% confidence interval] in LEADER: 1.15 [1.03; 1.29], P = .0136; SUSTAIN 6: 1.56 [1.14; 2.17], P = .0064). Liraglutide and semaglutide consistently reduced cardiovascular risk in patients with and without microvascular disease.",2020,Patients with microvascular disease were shown to have increased risk of major adverse cardiovascular events (MACE) compared with patients without microvascular disease (hazard ratio [95% confidence interval] in LEADER: 1.15 [1.03;1.29],"['9340 patients from LEADER and 3297 patients from SUSTAIN 6 were included in this analysis; of these, 5761 and 2356 had a history of microvascular disease at baseline and 3835 and 1640 had a history of both microvascular and macrovascular disease, respectively', 'patients with type 2 diabetes treated with liraglutide and semaglutide, respectively, compared with', 'Patients with microvascular disease', 'patients with and without microvascular disease', 'type 2 diabetes']","['liraglutide', 'Liraglutide', 'placebo']","['risk of major adverse cardiovascular events (MACE', 'cardiovascular risk reduction', 'cardiovascular risk', 'cardiovascular outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2609253', 'cui_str': 'Macrovascular disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",9340.0,0.266225,Patients with microvascular disease were shown to have increased risk of major adverse cardiovascular events (MACE) compared with patients without microvascular disease (hazard ratio [95% confidence interval] in LEADER: 1.15 [1.03;1.29],"[{'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""St. Michael's Hospital and University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Bain', 'Affiliation': 'Swansea University Medical School, Swansea, UK.'}, {'ForeName': 'Julie Broe', 'Initials': 'JB', 'LastName': 'Honoré', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'F E Mann', 'Affiliation': 'KfH Kidney Center, Munich, and Department of Nephrology, Friedrich Alexander University of Erlangen, Erlangen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'A Nauck', 'Affiliation': 'Diabetes Center Bochum-Hattingen, St Josef Hospital (Ruhr-Universität Bochum), Bochum, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'E Pratley', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, Florida, USA.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sejersten Ripa', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14140']
1406,32647961,Three-dimensional prediction of nose morphology in Chinese young adults: a pilot study combining cone-beam computed tomography and 3dMD photogrammetry system.,"The nose is the most prominent part of the face and is a crucial factor for facial esthetics as well as facial reconstruction. Although some studies have explored the features of external nose and predicted the relationships between skeletal structures and soft tissues in the nasal region, the reliability and applicability of methods used in previous studies have not been reproduced. In addition, the majority of previous studies have focused on the sagittal direction, whereas the thickness of the soft tissues was rarely analyzed in three dimensions. A few studies have explained the specific characteristics of the nose of Chinese individuals. The aim of this study was to investigate the relationship between the hard nasal structures and soft external nose in three dimensions and to predict the morphology of the nose based on hard-tissue measurements. To eliminate the influence of low resolution of CBCT and increase the accuracy of measurement, three-dimensional (3D) images captured by cone-beam computed tomography (CBCT) and 3dMD photogrammetry system were used in this study. Twenty-six measurements (15 measurements for hard tissue and 11 measurements for soft tissue) based on 5 craniometric and 5 capulometric landmarks of the nose of 120 males and 120 females were obtained. All of the subjects were randomly divided into an experimental group (180 subjects consisting of 90 males and 90 females) and a test group (60 subjects consisting of 30 males and 30 females). Correlation coefficients between hard- and soft-tissue measurements were analyzed, and regression equations were obtained based on the experimental group and served as predictors to estimate nasal morphology in the test group. Most hard- and soft-tissue measurements appeared significantly different between genders. The strongest correlation was found between basis nasi protrusion and nasospinale protrusion (0.499) in males, and nasal height and nTr-nsTr (0.593) in females. For the regression equations, the highest value of R 2  was observed in the nasal bridge length in males (0.257) and nasal tip protrusion in females (0.389). The proportion of subjects with predicted errors < 10% was over 86.7% in males and 70.0% in females. Our study proved that a combined CBCT and 3dMD photogrammetry system is a reliable method for nasal morphology estimation. Further research should investigate other influencing factors such as age, skeletal types, facial proportions, or population variance in nasal morphology estimation.",2020,Our study proved that a combined CBCT and 3dMD photogrammetry system is a reliable method for nasal morphology estimation.,"['180 subjects consisting of 90 males and 90 females) and a test group (60 subjects consisting of 30 males and 30 females', 'Chinese young adults', '120 males and 120 females were obtained']",['cone-beam computed tomography and 3dMD photogrammetry system'],"['nasal bridge length', 'nasal tip protrusion']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}]","[{'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0031747', 'cui_str': 'Photogrammetry'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0225408', 'cui_str': 'Structure of dorsum of nose'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0225409', 'cui_str': 'Structure of apex of nose'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}]",180.0,0.0203007,Our study proved that a combined CBCT and 3dMD photogrammetry system is a reliable method for nasal morphology estimation.,"[{'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Chu', 'Affiliation': ""Key Laboratory of Shaanxi Province for Craniofacial Precision Medicine Research, College of Stomatology, Xi'an Jiaotong University, 98 XiWu Road, Xi'an, 710004, Shaanxi, People's Republic of China.""}, {'ForeName': 'Jia-Min', 'Initials': 'JM', 'LastName': 'Zhao', 'Affiliation': ""Key Laboratory of Shaanxi Province for Craniofacial Precision Medicine Research, College of Stomatology, Xi'an Jiaotong University, 98 XiWu Road, Xi'an, 710004, Shaanxi, People's Republic of China.""}, {'ForeName': 'Meng-Qi', 'Initials': 'MQ', 'LastName': 'Han', 'Affiliation': ""Key Laboratory of Shaanxi Province for Craniofacial Precision Medicine Research, College of Stomatology, Xi'an Jiaotong University, 98 XiWu Road, Xi'an, 710004, Shaanxi, People's Republic of China.""}, {'ForeName': 'Qing-Nan', 'Initials': 'QN', 'LastName': 'Mou', 'Affiliation': ""Key Laboratory of Shaanxi Province for Craniofacial Precision Medicine Research, College of Stomatology, Xi'an Jiaotong University, 98 XiWu Road, Xi'an, 710004, Shaanxi, People's Republic of China.""}, {'ForeName': 'Ling-Ling', 'Initials': 'LL', 'LastName': 'Ji', 'Affiliation': ""Key Laboratory of Shaanxi Province for Craniofacial Precision Medicine Research, College of Stomatology, Xi'an Jiaotong University, 98 XiWu Road, Xi'an, 710004, Shaanxi, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ""Key Laboratory of Shaanxi Province for Craniofacial Precision Medicine Research, College of Stomatology, Xi'an Jiaotong University, 98 XiWu Road, Xi'an, 710004, Shaanxi, People's Republic of China.""}, {'ForeName': 'Teng', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': ""College of Medicine and Forensics, Xi'an Jiaotong University Health Science Center, 76 West Yanta Road, Xi'an, 710004, Shaanxi, People's Republic of China.""}, {'ForeName': 'Shao-Yi', 'Initials': 'SY', 'LastName': 'Du', 'Affiliation': ""Institute of Artificial Intelligence and Robotics, College of Artificial Intelligence, Xi'an Jiaotong University, 28 Xianning West Road, Xi'an, 710049, Shaanxi, People's Republic of China. dushaoyi@xjtu.edu.cn.""}, {'ForeName': 'Yu-Cheng', 'Initials': 'YC', 'LastName': 'Guo', 'Affiliation': ""Key Laboratory of Shaanxi Province for Craniofacial Precision Medicine Research, College of Stomatology, Xi'an Jiaotong University, 98 XiWu Road, Xi'an, 710004, Shaanxi, People's Republic of China. xjtu-guoyucheng@163.com.""}]",International journal of legal medicine,['10.1007/s00414-020-02351-8']
1407,32648019,"Correction to: Low-phytate wholegrain bread instead of high-phytate wholegrain bread in a total diet context did not improve iron status of healthy Swedish females: a 12 week, randomized, parallel-design intervention study.",ue to author error the paper was published wit.,2020,ue to author error the paper was published wit.,['healthy Swedish females'],['wholegrain bread'],[],"[{'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0006138', 'cui_str': 'Bread'}]",[],,0.0171175,ue to author error the paper was published wit.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hoppe', 'Affiliation': 'Department of Gastroenterology and Hepatology, Clinical Nutrition Unit, Sahlgrenska University Hospital, Göteborg, Sweden. michael.hoppe@nutrition.gu.se.'}, {'ForeName': 'Alastair B', 'Initials': 'AB', 'LastName': 'Ross', 'Affiliation': 'Department of Biology and Biological Engineering, Food and Nutrition Science, Chalmers University of Technology, Göteborg, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Svelander', 'Affiliation': 'Department of Biology and Biological Engineering, Food and Nutrition Science, Chalmers University of Technology, Göteborg, Sweden.'}, {'ForeName': 'Ann-Sofie', 'Initials': 'AS', 'LastName': 'Sandberg', 'Affiliation': 'Department of Biology and Biological Engineering, Food and Nutrition Science, Chalmers University of Technology, Göteborg, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Hulthén', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy at the University of Gothenburg, Göteborg, Sweden.'}]",European journal of nutrition,['10.1007/s00394-020-02286-1']
1408,32648021,"Reply to the comments by Vorland et al. on our paper: ""low-phytate wholegrain bread instead of high-phytate wholegrain bread in a total diet context did not improve iron status of healthy Swedish females: a 12-week, randomized, parallel-design intervention study"".",,2020,,['healthy Swedish females'],[],[],"[{'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],[],,0.0128649,,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hoppe', 'Affiliation': 'Department of Gastroenterology and Hepatology, Clinical Nutrition Unit, Sahlgrenska University Hospital, Göteborg, Sweden. michael.hoppe@nutrition.gu.se.'}, {'ForeName': 'Alastair B', 'Initials': 'AB', 'LastName': 'Ross', 'Affiliation': 'Lincoln Research Centre, AgResearch, Springs Road, Lincoln, Christchurch, New Zealand.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Svelander', 'Affiliation': 'Department of Biology and Biological Engineering, Food and Nutrition Science, Chalmers University of Technology, Göteborg, Sweden.'}, {'ForeName': 'Ann-Sofie', 'Initials': 'AS', 'LastName': 'Sandberg', 'Affiliation': 'Department of Biology and Biological Engineering, Food and Nutrition Science, Chalmers University of Technology, Göteborg, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Hulthén', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy at the University of Gothenburg, Göteborg, Sweden.'}]",European journal of nutrition,['10.1007/s00394-020-02288-z']
1409,32651146,Short-term efficacy of ORS formulation and propranolol regimen in children with POTS.,"BACKGROUND


To evaluate the short-term effectiveness of reduced-osmolarity oral rehydration salt formulation (ORS) and propranolol in children diagnosed with postural orthostatic tachycardia syndrome (POTS) in head-up tilt testing (HUTT).
METHODS


Children were admitted with symptoms of orthostatic intolerance (OI) occurring in a standing position and disappearing in the supine position. Patients with heart rate increments of ≥40bpm and symptoms of OI constituted the pediatric POTS group in HUTT. A total of 70 pediatric patients with POTS were included in the study. POTS patients were divided into two groups based on whether they were prescribed reduced-osmolarity ORS and propranolol or not. The study group comprised patients on a regimen of reduced-osmolarity ORS and propranolol (n=34), while the control group comprised patients who were not prescribed any medication (n=36). The frequency of symptoms and standardized symptom scores were analyzed before and after 3 months of treatment in both groups.
RESULTS


The post-treatment frequency of syncopal attacks was significantly reduced in both groups (P<0.01 for both groups), but the post-treatment standardized symptom scores were significantly reduced in the pediatric study group compared with the control group (P<0.01).
CONCLUSION


The frequency of syncopal attacks was significantly reduced and the symptom scores for OI were improved in the study group. The improvement in OI symptom scores was better in the treatment group than in the control group. The control group symptoms persisted and caused extreme difficulty in their daily activities. In view of its clinical efficacy, we strongly advocate the use of combined treatment of reduced-osmolarity ORS and low-dose propranolol in pediatric patients with POTS.",2020,"The post-treatment frequency of syncopal attacks was significantly reduced in both groups (P<0.01 for both groups), but the post-treatment standardized symptom scores were significantly reduced in the pediatric study group compared with the control group (P<0.01).
","['Children were admitted with symptoms of orthostatic intolerance (OI) occurring in a standing position and disappearing in the supine position', 'children with POTS', 'children diagnosed with postural orthostatic tachycardia syndrome (POTS) in head-up tilt testing (HUTT', 'n=34), while the control group comprised patients who were not prescribed any medication (n=36', 'Patients with heart rate increments of ≥40bpm and symptoms of OI constituted the pediatric POTS group in HUTT', 'pediatric patients with POTS', '70 pediatric patients with POTS were included in the study']","['reduced-osmolarity oral rehydration salt formulation (ORS) and propranolol', 'propranolol', 'reduced-osmolarity ORS and propranolol', 'ORS formulation and propranolol']","['frequency of symptoms and standardized symptom scores', 'frequency of syncopal attacks', 'syncopal attacks', 'standardized symptom scores', 'symptom scores for OI', 'OI symptom scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1535893', 'cui_str': 'Orthostatic intolerance'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C1299624', 'cui_str': 'Postural orthostatic tachycardia syndrome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1293898', 'cui_str': 'Head up'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0029387', 'cui_str': 'Osmolarity'}, {'cui': 'C3653405', 'cui_str': 'Oral rehydration salt formulations'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0436350', 'cui_str': 'Symptom frequency'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}, {'cui': 'C1535893', 'cui_str': 'Orthostatic intolerance'}]",70.0,0.0281252,"The post-treatment frequency of syncopal attacks was significantly reduced in both groups (P<0.01 for both groups), but the post-treatment standardized symptom scores were significantly reduced in the pediatric study group compared with the control group (P<0.01).
","[{'ForeName': 'Yilmaz', 'Initials': 'Y', 'LastName': 'Yozgat', 'Affiliation': 'Department of Pediatric Cardiology, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Hafize Otcu', 'Initials': 'HO', 'LastName': 'Temur', 'Affiliation': 'Department of Radiology, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Senay', 'Initials': 'S', 'LastName': 'Coban', 'Affiliation': 'Department of Pediatric Cardiology, Istanbul Medipol University, Istanbul, Turkey.'}, {'ForeName': 'Taliha', 'Initials': 'T', 'LastName': 'Oner', 'Affiliation': ""Department of Pediatric Cardiology, Izmir Dr. Behcet Uz Children's Hospital, Izmir, Turkey.""}, {'ForeName': 'Utku', 'Initials': 'U', 'LastName': 'Karaarslan', 'Affiliation': ""Department of Pediatrics, Izmir Dr. Behcet Uz Children's Hospital, Izmir, Turkey.""}, {'ForeName': 'Can Yilmaz', 'Initials': 'CY', 'LastName': 'Yozgat', 'Affiliation': 'Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey. Electronic address: yozgatyilmaz@gmail.com.'}, {'ForeName': 'Cem', 'Initials': 'C', 'LastName': 'Karadeniz', 'Affiliation': ""Department of Pediatric Cardiology, Izmir Dr. Behcet Uz Children's Hospital, Izmir, Turkey.""}, {'ForeName': 'Serap Nur', 'Initials': 'SN', 'LastName': 'Ergor', 'Affiliation': 'Department of Neonatology, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Ufuk', 'Initials': 'U', 'LastName': 'Erenberk', 'Affiliation': 'Department of Pediatrics, Bezmialem Vakif University, Istanbul, Turkey.'}]",Archives de pediatrie : organe officiel de la Societe francaise de pediatrie,['10.1016/j.arcped.2020.06.001']
1410,32650518,"Trimebutine Maleate Monotherapy for Functional Dyspepsia: A Multicenter, Randomized, Double-Blind Placebo Controlled Prospective Trial.","Background and Objectives:  Functional dyspepsia (FD) is one of the most common functional gastrointestinal disorders; it has a great impact on patient quality of life and is difficult to treat satisfactorily. This study evaluates the efficacy and safety of trimebutine maleate (TM) in patients with FD.  Materials and Methods : Α multicenter, randomized, double-blind, placebo controlled, prospective study was conducted, including 211 patients with FD. Participants were randomized to receive TM 300 mg twice per day (BID, 108 patients) or placebo BID (103 patients) for 4 weeks. The Glasgow Dyspepsia Severity Score (GDSS) was used to evaluate the relief of dyspepsia symptoms. Moreover, as a pilot secondary endpoint, a substudy (eight participants on TM and eight on placebo) was conducted in to evaluate gastric emptying (GE), estimated using a 99mTc-Tin Colloid Semi Solid Meal Scintigraphy test.  Results : Of the 211 patients enrolled, 185 (87.7%) (97 (52.4%) in the TM group and 88 (47.6%) in the placebo group) completed the study and were analyzed. The groups did not differ in their demographic and medical history data. Regarding symptom relief, being the primary endpoint, a statistically significant reduction in GDSS for the TM group was revealed between the first (2-week) and final (4-week) visit ( p -value = 0.02). The 99 mTc-Tin Colloid Semi Solid Meal Scintigraphy testing showed that TM significantly accelerated GE obtained at 50 min (median emptying 75.5% in the TM group vs. 66.6% in the placebo group,  p  = 0.036). Adverse effects of low to moderate severity were reported in 12.3% of the patients on TM.  Conclusion : TM monotherapy appears to be an effective and safe approach to treating FD, although the findings presented here warrant further confirmation.",2020,"Regarding symptom relief, being the primary endpoint, a statistically significant reduction in GDSS for the TM group was revealed between the first (2-week) and final (4-week) visit ( p -value = 0.02).","['211 patients with FD', '211 patients enrolled, 185 (87.7%) (97 (52.4%) in the TM group and 88 (47.6%) in the placebo group) completed the study and were analyzed', 'Functional Dyspepsia', 'patients with FD']","['Placebo', 'Trimebutine Maleate Monotherapy', 'Functional dyspepsia (FD', 'TM monotherapy', 'TM', 'trimebutine maleate (TM', 'placebo BID', 'placebo']","['relief of dyspepsia symptoms', 'efficacy and safety', 'Glasgow Dyspepsia Severity Score (GDSS', 'GDSS', 'gastric emptying (GE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0877833', 'cui_str': 'Trimebutine maleate'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}]","[{'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}]",211.0,0.534728,"Regarding symptom relief, being the primary endpoint, a statistically significant reduction in GDSS for the TM group was revealed between the first (2-week) and final (4-week) visit ( p -value = 0.02).","[{'ForeName': 'Jannis', 'Initials': 'J', 'LastName': 'Kountouras', 'Affiliation': 'Second Medical Clinic, School of Medicine, Aristotle University of Thessaloniki, Ippokration Hospital, 54642 Thessaloniki, Macedonia, Greece.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Gavalas', 'Affiliation': 'Second Medical Clinic, School of Medicine, Aristotle University of Thessaloniki, Ippokration Hospital, 54642 Thessaloniki, Macedonia, Greece.'}, {'ForeName': 'Apostolis', 'Initials': 'A', 'LastName': 'Papaefthymiou', 'Affiliation': 'Second Medical Clinic, School of Medicine, Aristotle University of Thessaloniki, Ippokration Hospital, 54642 Thessaloniki, Macedonia, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Tsechelidis', 'Affiliation': 'Second Medical Clinic, School of Medicine, Aristotle University of Thessaloniki, Ippokration Hospital, 54642 Thessaloniki, Macedonia, Greece.'}, {'ForeName': 'Stergios A', 'Initials': 'SA', 'LastName': 'Polyzos', 'Affiliation': 'Second Medical Clinic, School of Medicine, Aristotle University of Thessaloniki, Ippokration Hospital, 54642 Thessaloniki, Macedonia, Greece.'}, {'ForeName': 'Serhat', 'Initials': 'S', 'LastName': 'Bor', 'Affiliation': 'Division of Gastroenterology, Ege University School of Medicine, 35330 Izmir, Turkey.'}, {'ForeName': 'Mircea', 'Initials': 'M', 'LastName': 'Diculescu', 'Affiliation': 'Gastroenterology and Hepatology Department, Clinic Fundeni Institute, 4204003 Bucharest, Romania.'}, {'ForeName': 'Κhaled', 'Initials': 'Κ', 'LastName': 'Jadallah', 'Affiliation': 'Department of Internal Medicine, King Abdullah University Hospital, 22110 Irbid, Jordan.'}, {'ForeName': 'Mazurek', 'Initials': 'M', 'LastName': 'Tadeusz', 'Affiliation': 'Medicor Centrum, ul. Jabłoskiego 2/4 35-068 Rzeszów, Poland.'}, {'ForeName': 'Tarkan', 'Initials': 'T', 'LastName': 'Karakan', 'Affiliation': 'Department of Gastroenterology, Gazi University School of Medicine, 06560 Ankara, Turkey.'}, {'ForeName': 'Αnna', 'Initials': 'Α', 'LastName': 'Bochenek', 'Affiliation': 'Centrum Badawcze Wspolczesnej Terapii, 02679 Warszawa, Poland.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Rozciecha', 'Affiliation': 'LexMedica, Rudolfa Weigla 12, Krzyki, 53114 Wrocław, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Dabrowski', 'Affiliation': 'Department of Rheumatology of Clinical Hospital 2, University of Rzeszow, Lwowska 60, 35-301 Rzeszow, Poland.'}, {'ForeName': 'Zeno', 'Initials': 'Z', 'LastName': 'Sparchez', 'Affiliation': 'Third Medical Clinic, University of Medicine and Pharmacy, Croitorilor Street no.19-21, 400162 Cluj-Napoca, Romania.'}, {'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Sezgin', 'Affiliation': 'Mersin University, Faculty of Medicine, Department of Gastroenterology, 33343 Mersin, Turkey.'}, {'ForeName': 'Macit', 'Initials': 'M', 'LastName': 'Gülten', 'Affiliation': 'Department of Gastroenterology, Uludag University, 16059 Bursa, Turkey.'}, {'ForeName': 'Niazy Abu', 'Initials': 'NA', 'LastName': 'Farsakh', 'Affiliation': 'Department of Internal Medicine, King Abdullah University Hospital, 22110 Irbid, Jordan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Doulberis', 'Affiliation': 'Second Medical Clinic, School of Medicine, Aristotle University of Thessaloniki, Ippokration Hospital, 54642 Thessaloniki, Macedonia, Greece.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56070339']
1411,32652307,Comparing Needles and Methods of Endoscopic Ultrasound-Guided Fine-Needle Biopsy to Optimize Specimen Quality and Diagnostic Accuracy for Patients With Pancreatic Masses in a Randomized Trial.,"BACKGROUND & AIMS


Given the lack of procedure standardization, findings vary from analyses of pancreatic tissues collected by endoscopic ultrasound-guided fine-needle biopsy. It is not clear which needle and technique yield the best specimen for analysis. We compared the specimen quality and accuracy of diagnoses made from samples collected by fine-needle biopsy needles using different collection techniques.
METHODS


Patients found to have pancreatic masses during imaging (n = 129) were assigned randomly to groups from whom pancreatic tissue samples were collected by reverse-bevel, Menghini-tip, franseen, or fork-tip needles. A second randomization determined the technical sequence of biopsies in each patient (suction, no suction, and stylet retraction). Two independent pathologists, blinded to the type of needle and sampling technique, analyzed all the samples. Final diagnoses of malignancy were made based on surgical resection, death from cancer progression, or findings from radiology or clinical follow-up evaluations (reference standard). The primary objective was to compare the cellularity of the samples collected, defined as the proportion of core tissue in the biopsy sample. Secondary objectives were to compare the accuracy of diagnoses made from biopsy samples and identify factors associated with high cellularity.
RESULTS


One-hundred and nine patients had a final diagnosis of malignancy (84.5%) and 20 patients had benign disease (15.5%). Samples collected by fork-tip or franseen needles had significantly higher cellularity than samples collected by reverse-bevels or Menghini-tip needles (P < .001). Neoplasias were identified with greater than 90% accuracy using samples collected by fork-tip or franseen needles (P < .001 compared with other needles). On multivariable regression analysis, use of franseen needles (odds ratio [OR], 4.42; 95% CI, 2.58-7.58; P < .001) or fork-tip needles (OR, 3.86; 95% CI, 2.24-6.64; P < .001), stylet retraction (OR, 2.13; 95% CI, 1.21-3.72; P = .008), no suction (OR, 2.74; 95% CI, 1.57-4.80; P < .001), and pancreatic mass larger than 3 cm (OR, 1.92; 95% CI, 1.21-3.05; P = .005) were associated with high cellularity of the sample.
CONCLUSIONS


In patients with suspected pancreatic cancer, samples with the highest degree of cellularity in a single biopsy, resulting in a diagnostic accuracy of 90% of higher, were collected by fine-needle biopsy using the franseen or fork-tip needle. Clinicaltrials.gov no: NCT04085055.",2020,"On multivariable regression analysis, use of franseen needles (odds ratio [OR], 4.42; 95% CI, 2.58-7.58; P<.001) or fork-tip needles (OR, 3.86; 95% CI, 2.24-6.64; P<.001), stylet retraction (OR, 2.13; 95% CI, 1.21-3.72; P=.008), no suction (OR, 2.74; 95% CI, 1.57-4.80; P<.001), and pancreatic mass >3 cm (OR, 1.92; 95% CI, 1.21-3.05; P=.005) were associated with high cellularity of sample.
","['Patients with Pancreatic Masses', 'Patients found to have pancreatic masses during imaging (n=129', 'patients with suspected pancreatic cancer']","['pancreatic tissue samples were collected by reverse-bevel, Menghini-tip, franseen, or fork-tip needles', 'Endoscopic Ultrasound-Guided Fine-Needle Biopsy']","['accuracy of diagnoses made from biopsy samples and identify factors associated with high cellularity', 'final diagnosis of malignancy', 'benign disease', 'stylet retraction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877425', 'cui_str': 'Mass of pancreas'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}]","[{'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C1292533', 'cui_str': 'Tissue specimen'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0546910', 'cui_str': 'Fork'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0085846', 'cui_str': 'Fine needle biopsy'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0677862', 'cui_str': 'Biopsy sample'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332144', 'cui_str': 'Final diagnosis (discharge)'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0183663', 'cui_str': 'Stylet'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}]",129.0,0.0481015,"On multivariable regression analysis, use of franseen needles (odds ratio [OR], 4.42; 95% CI, 2.58-7.58; P<.001) or fork-tip needles (OR, 3.86; 95% CI, 2.24-6.64; P<.001), stylet retraction (OR, 2.13; 95% CI, 1.21-3.72; P=.008), no suction (OR, 2.74; 95% CI, 1.57-4.80; P<.001), and pancreatic mass >3 cm (OR, 1.92; 95% CI, 1.21-3.05; P=.005) were associated with high cellularity of sample.
","[{'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Young Bang', 'Affiliation': 'Center for Interventional Endoscopy.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Krall', 'Affiliation': 'Department of Pathology, AdventHealth Orlando, Orlando, Florida.'}, {'ForeName': 'Nirag', 'Initials': 'N', 'LastName': 'Jhala', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Temple University Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Charanjeet', 'Initials': 'C', 'LastName': 'Singh', 'Affiliation': 'Department of Pathology, AdventHealth Orlando, Orlando, Florida.'}, {'ForeName': 'Mohamedtaki', 'Initials': 'M', 'LastName': 'Tejani', 'Affiliation': 'Department of Medical Oncology.'}, {'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Arnoletti', 'Affiliation': 'Center for Surgical Oncology, AdventHealth Cancer Institute, Orlando, Florida.'}, {'ForeName': 'Udayakumar', 'Initials': 'U', 'LastName': 'Navaneethan', 'Affiliation': 'Center for Interventional Endoscopy.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hawes', 'Affiliation': 'Center for Interventional Endoscopy.'}, {'ForeName': 'Shyam', 'Initials': 'S', 'LastName': 'Varadarajulu', 'Affiliation': 'Center for Interventional Endoscopy. Electronic address: svaradarajulu@yahoo.com.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.06.042']
1412,32652863,Impact of interval walking training managed through smart mobile devices on albuminuria and leptin/adiponectin ratio in patients with type 2 diabetes.,"BACKGROUND


Interval walking training has demonstrated more pronounced positive effects on physical fitness and metabolism in type 2 diabetes (T2D), compared to continuous walking. One of the pathogenic mechanisms of T2D is associated with derangements in leptin/adiponectin axis, which might predispose affected individuals to vascular inflammation and albuminuria. The aim of this study was to investigate the effects of interval walking training delivered through smart mobile devices upon albuminuria and leptin/adiponectin ratio in patients with T2D.
METHODS


Patients with T2D aged 35-75 were randomized into control (n = 26) and interval training (IT, n = 14) groups. Patients in IT group had to perform three 60-min interval walking sessions (3 min intervals of slow and fast walking with the intensity of 40% and 70% of the peak energy expenditure) per week delivered by smartphone application for four months. The adherence to training was monitored remotely. Outcome measures were albuminuria, leptin/adiponectin ratio, obesity indicators, and glycaemic control. Leptin and adiponectin concentration was measured in serum samples by Luminex technology.
RESULTS


In the IT group compared to control group, we observed a statistically significant decrease in albuminuria (p = .002) and leptin/adiponectin ratio (p = .01), as well as a decrease in HbA1c close to statistical significance (p = .09). In IT group, changes in leptin/adiponectin ratio correlated significantly with changes in hip circumference (p = .024).
CONCLUSION


Interval walking training is beneficial for vascular health in T2D via impact on albuminuria and leptin/adiponectin ratio.",2020,"In IT group, changes in leptin/adiponectin ratio correlated significantly with changes in hip circumference (p = .024).
","['patients with T2D.\nMETHODS\n\n\nPatients with T2D aged 35-75', 'patients with type 2 diabetes']","['interval walking training managed through smart mobile devices', 'smart mobile devices', 'interval walking training', 'Interval walking training']","['hip circumference', 'albuminuria and leptin/adiponectin ratio', 'Leptin and adiponectin concentration', 'albuminuria, leptin/adiponectin ratio, obesity indicators, and glycaemic control', 'leptin/adiponectin ratio', 'changes in leptin/adiponectin ratio', 'albuminuria']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",75.0,0.0424762,"In IT group, changes in leptin/adiponectin ratio correlated significantly with changes in hip circumference (p = .024).
","[{'ForeName': 'Jelizaveta', 'Initials': 'J', 'LastName': 'Sokolovska', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Ostrovska', 'Affiliation': 'Latvian Academy of Sport Education, Riga, Latvia.'}, {'ForeName': 'Leonora', 'Initials': 'L', 'LastName': 'Pahirko', 'Affiliation': 'Faculty of Physics, Mathematics and Optometry, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Gunita', 'Initials': 'G', 'LastName': 'Varblane', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Ksenija', 'Initials': 'K', 'LastName': 'Krilatiha', 'Affiliation': 'Faculty of Computing, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Austris', 'Initials': 'A', 'LastName': 'Cirulnieks', 'Affiliation': 'Faculty of Computing, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Inese', 'Initials': 'I', 'LastName': 'Folkmane', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Valdis', 'Initials': 'V', 'LastName': 'Pirags', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Janis', 'Initials': 'J', 'LastName': 'Valeinis', 'Affiliation': 'Faculty of Physics, Mathematics and Optometry, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Aija', 'Initials': 'A', 'LastName': 'Klavina', 'Affiliation': 'Latvian Academy of Sport Education, Riga, Latvia.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Selavo', 'Affiliation': 'Faculty of Computing, University of Latvia, Riga, Latvia.'}]",Physiological reports,['10.14814/phy2.14506']
1413,32653539,The management of diabetes in everyday life study: Design and methods for a pragmatic randomized controlled trial comparing the effectiveness of text messaging versus health coaching.,"Background African American patients with uncontrolled diabetes living in medically underserved areas need effective clinic-based interventions to improve self-care behaviors. Text messaging (TM) and health coaching (HC) are among the most promising low-cost population-based approaches, but little is known about their comparative effectiveness in real-world clinical settings. Objective Use a pragmatic randomized controlled trial design to determine the comparative effectiveness of TM and HC with enhanced usual care (EC) in African American adults with uncontrolled diabetes and multiple chronic health conditions. Methods/design The Management of Diabetes in Everyday Life (MODEL) study is randomizing 646 patients (n = 581with anticipated 90% retention) to 3 intervention arms: TM, HC, and EC. Participants are African American adults living in medically underserved areas of the Mid-South, age ≥ 18, with uncontrolled diabetes (A1c ≥ 8), one or more additional chronic conditions, and who have a phone with texting and voicemail capability. Primary outcome measures: the general diet, exercise, and medication adherence subscales of the revised Summary of Diabetes Self-Care Activities questionnaire assessed at one year. Secondary outcomes: diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c). The study will also assess heterogeneity of treatment effects by six key baseline participant characteristics. Conclusions We describe the design and methods of the MODEL study along with design revisions required during implementation in a pragmatic setting. This trial, upon its conclusion, will allow us to compare the effectiveness of two promising low-cost primary care-based strategies for supporting self-care behaviors among African Americans individuals with uncontrolled diabetes. ClinicalTrials.gov registration number: NCT02957513.",2020,"Secondary outcomes: diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c).","['African American adults with uncontrolled diabetes and multiple chronic health conditions', ' African American patients with uncontrolled diabetes living in medically underserved areas', 'Participants are African American adults living in medically underserved areas of the Mid-South, age ≥ 18, with uncontrolled diabetes (A1c ≥ 8), one or more additional chronic conditions, and who have a phone with texting and voicemail capability', '646 patients (n\u202f=\u202f581with anticipated 90% retention) to 3 intervention arms: TM, HC, and EC', 'African Americans individuals with uncontrolled diabetes']","['Text messaging (TM) and health coaching (HC', 'text messaging versus health coaching', 'TM and HC with enhanced usual care (EC']","['diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c', 'general diet, exercise, and medication adherence subscales of the revised Summary of Diabetes Self-Care Activities questionnaire assessed at one year']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C3266262', 'cui_str': 'Multiple chronic diseases'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0025112', 'cui_str': 'Area, Medically Underserved'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0301563', 'cui_str': 'General diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4082117', 'cui_str': 'One year'}]",646.0,0.105121,"Secondary outcomes: diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c).","[{'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Bailey', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Division of General Internal Medicine, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America; Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America. Electronic address: jeb@uthsc.edu.'}, {'ForeName': 'Satya', 'Initials': 'S', 'LastName': 'Surbhi', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Division of General Internal Medicine, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Gatwood', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; College of Pharmacy, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Butterworth', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Q-consult, LLC, St. Petersburg, FL, United States of America.'}, {'ForeName': 'Mace', 'Initials': 'M', 'LastName': 'Coday', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Sohul A', 'Initials': 'SA', 'LastName': 'Shuvo', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Institute for Health Outcomes and Policy, College of Graduate Health Sciences, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Ankur A', 'Initials': 'AA', 'LastName': 'Dashputre', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Institute for Health Outcomes and Policy, College of Graduate Health Sciences, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Brooks', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Department of Surgery, Anne Arundel Medical Center, Annapolis, MD, United States of America.'}, {'ForeName': 'Bonnie L', 'Initials': 'BL', 'LastName': 'Binkley', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Carrie Jo', 'Initials': 'CJ', 'LastName': 'Riordan', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Helmut O', 'Initials': 'HO', 'LastName': 'Steinberg', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Division of Endocrinology, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Gutierrez', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Haley', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Cardella L', 'Initials': 'CL', 'LastName': 'Leak', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Tolley', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106080']
1414,32654257,Improving Follow-up Attendance for Discharged Emergency Care Patients Using Automated Phone System to Self-schedule: A Randomized Controlled Trial.,"BACKGROUND


Automated phone appointment reminders have improved adherence with follow-up appointments in a variety of hospital settings, but have mixed results in patients discharged from the emergency department (ED). Increasing adherence to follow-up care has been a priority in the ED to improve patient outcomes and reduce unnecessary future visits.
METHODS


We conducted a prospective randomized open, blinded end-point (PROBE) trial of 278 adult patients discharged from the ED and referred to a provider for follow-up care. Participants in the intervention arm received a self-scheduling text or phone message that automatically connected them to their referral provider to schedule a follow-up appointment and sent them appointment reminders. Those in the control arm received standard-of-care written instructions to contact listed referral providers. The primary outcome was time to appointment. The secondary outcome was time to return visit to the ED.
RESULTS


The automated reminders increased the cumulative incidence of keeping the referral appointment after ED discharge (p < 0.001, Gray's test). Of participants randomized to the automated phone intervention, 49.3% (n = 74) kept their follow-up appointment versus 23.4% (n = 30) in the control arm, with a hazard ratio (HR) and 95% confidence interval (CI) over the duration of the study period of 2.4 (1.6 to 3.7; p < 0.001). In a sensitivity analysis using 30 days of follow-up data, 42.0% (n = 63) of participants randomized to the phone intervention kept their follow-up versus 21.1% (n = 27) in the control arm, with a HR (95% CI) of 2.2 (1.4 to 3.5; p < 0.001). There was no difference in ED revisits between the intervention and control group within 120 days postdischarge.
CONCLUSIONS


An automated self-scheduling phone system significantly improved follow-up adherence after ED discharge, but did not decrease ED revisits.",2020,"An automated self-scheduling phone system significantly improved follow-up adherence after ED discharge, but did not decrease ED revisits.","['278 adult patients discharged from the ED and referred to a provider for follow-up care', 'patients discharged from the emergency department (ED', 'Discharged Emergency Care Patients']",['self-scheduling text or phone message that automatically connected them to their referral provider to schedule a follow-up appointment and sent them appointment reminders'],"['cumulative incidence of keeping the referral appointment after ED discharge', 'time to return visit to the ED', 'ED revisits', 'time to appointment']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C3899107', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205539', 'cui_str': 'Scheduled - procedure status'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}]",278.0,0.137672,"An automated self-scheduling phone system significantly improved follow-up adherence after ED discharge, but did not decrease ED revisits.","[{'ForeName': 'Kyla L', 'Initials': 'KL', 'LastName': 'Bauer', 'Affiliation': 'From the, School of Medicine, Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Omolade O', 'Initials': 'OO', 'LastName': 'Sogade', 'Affiliation': 'From the, School of Medicine, Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Brian F', 'Initials': 'BF', 'LastName': 'Gage', 'Affiliation': 'General Medical Sciences, Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Ruoff', 'Affiliation': 'and the, Department of Emergency Medicine, School of Medicine, Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Lawrence M', 'Initials': 'LM', 'LastName': 'Lewis', 'Affiliation': 'and the, Department of Emergency Medicine, School of Medicine, Washington University, St. Louis, MO, USA.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14080']
1415,32659437,Testing the effectiveness of physical activity advice delivered via text messaging vs. human phone advisors in a Latino population: The On The Move randomized controlled trial design and methods.,"Physical inactivity is a key risk factor for a range of chronic diseases and conditions, yet, approximately 50% of U.S. adults fall below recommended levels of regular aerobic physical activity (PA). This is particularly true for ethnic minority populations such as Latino adults for whom few culturally adapted programs have been developed and tested. Text messaging (SMS) represents a convenient and accessible communication channel for delivering targeted PA information and support, but has not been rigorously evaluated against standard telehealth advising programs. The objective of the On The Move randomized controlled trial is to test the effectiveness of a linguistically and culturally targeted SMS PA intervention (SMS PA Advisor) versus two comparison conditions: a) a standard, staff-delivered phone PA intervention (Telephone PA Advisor) and b) an attention-control arm consisting of a culturally targeted SMS intervention to promote a healthy diet (SMS Nutrition Advisor). The study sample (N = 350) consists of generally healthy, insufficiently active Latino adults ages 35 years and older living in five northern California counties. Study assessments occur at baseline, 6, and 12 months, with a subset of participants completing 18-month assessments. The primary outcome is 12-month change in walking, and secondary outcomes include other forms of PA, assessed via validated self-report measures and supported by accelerometry, and physical function and well-being variables. Potential mediators and moderators of intervention success will be explored to better determine which subgroups do best with which type of intervention. Here we present the study design and methods, including recruitment strategies and yields. Trial Registration: clinicaltrial.gov Identifier = NCT02385591.",2020,Potential mediators and moderators of intervention success will be explored to better determine which subgroups do best with which type of intervention.,"['Latino population', 'The study sample (N\u202f=\u202f350) consists of generally healthy, insufficiently active Latino adults ages 35\u202fyears and older living in five northern California counties']","['phone PA intervention (Telephone PA Advisor) and b) an attention-control arm consisting of a culturally targeted SMS intervention', 'linguistically and culturally targeted SMS PA intervention (SMS PA Advisor', 'Text messaging (SMS', 'physical activity advice delivered via text messaging vs. human phone advisors']","['12-month change in walking, and secondary outcomes include other forms of PA, assessed via validated self-report measures and supported by accelerometry, and physical function and well-being variables']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0006754', 'cui_str': 'California'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",,0.0964757,Potential mediators and moderators of intervention success will be explored to better determine which subgroups do best with which type of intervention.,"[{'ForeName': 'Abby C', 'Initials': 'AC', 'LastName': 'King', 'Affiliation': 'Department of Epidemiology & Population Health, Stanford University School of Medicine, Stanford, CA 94305, United States of America; Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: king@stanford.edu.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Campero', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: icampero@stanford.edu.'}, {'ForeName': 'Jylana L', 'Initials': 'JL', 'LastName': 'Sheats', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: JSheats@tulane.edu.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Castro Sweet', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: cynthia@omadahealth.com.'}, {'ForeName': 'Patricia Rodriguez', 'Initials': 'PR', 'LastName': 'Espinosa', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: prespinosa@stanford.edu.'}, {'ForeName': 'Dulce', 'Initials': 'D', 'LastName': 'Garcia', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: dgarcia3@stanford.edu.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hauser', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: mehauser@stanford.edu.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Done', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: mdone@stanford.edu.'}, {'ForeName': 'Michele L', 'Initials': 'ML', 'LastName': 'Patel', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: michele.patel@stanford.edu.'}, {'ForeName': 'Nina M', 'Initials': 'NM', 'LastName': 'Parikh', 'Affiliation': 'CareMessage, Inc., San Francisco, California 94115, United States of America. Electronic address: nparikh@caremessage.org.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Corral', 'Affiliation': 'CareMessage, Inc., San Francisco, California 94115, United States of America. Electronic address: ccorral@caremessage.org.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Ahn', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: dahn@stanford.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106084']
1416,32661682,"Within-group comparisons led to unsubstantiated conclusions in ""Low-phytate wholegrain bread instead of high-phytate wholegrain bread in a total diet context did not improve iron status of healthy Swedish females: a 12-week, randomized, parallel-design intervention Study"".",,2020,,['healthy Swedish females'],[],[],"[{'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],[],,0.027488,,"[{'ForeName': 'Colby J', 'Initials': 'CJ', 'LastName': 'Vorland', 'Affiliation': 'Department of Applied Health Science, Indiana University School of Public Health-Bloomington, Bloomington, IN, USA. cvorland@iu.edu.'}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Mestre', 'Affiliation': 'Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington, IN, USA.'}, {'ForeName': 'Sachintha S', 'Initials': 'SS', 'LastName': 'Mendis', 'Affiliation': 'Department of Agricultural and Resource Economics, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Brown', 'Affiliation': 'Department of Applied Health Science, Indiana University School of Public Health-Bloomington, Bloomington, IN, USA. awb1@iu.edu.'}]",European journal of nutrition,['10.1007/s00394-020-02287-0']
1417,32666599,"Human Fetal Cell Therapy in Huntington's Disease: A Randomized, Multicenter, Phase II Trial.","BACKGROUND


Huntington's disease is a rare, severe, inherited neurodegenerative disease in which we assessed the safety and efficacy of grafting human fetal ganglionic eminence intrastriatally.
METHODS


Patients at the early stage of the disease were enrolled in the Multicentric Intracerebral Grafting in Huntington's Disease trial, a delayed-start phase II randomized study. After a run-in period of 12 months, patients were randomized at month 12 to either the treatment group (transplanted at month 13-month 14) or the control group and secondarily treated 20 months later (month 33-month 34). The primary outcome was total motor score compared between both groups 20 months postrandomization (month 32). Secondary outcomes included clinical, imaging, and electrophysiological findings and a comparison of pregraft and postgraft total motor score slopes during the entire study period (month 0-month 52) regardless of the time of transplant.
RESULTS


Of 54 randomized patients, 45 were transplanted; 26 immediately (treatment) and 19 delayed (control). Mean total motor score at month 32 did not differ between groups (treated controls difference in means adjusted for M12: +2.9 [95% confidence interval, -2.8 to 8.6]; P = 0.31). Its rate of decline after transplantation was similar to that before transplantation. A total of 27 severe adverse events were recorded in the randomized patients, 10 of which were related to the transplant procedure. Improvement of procedures during the trial significantly decreased the frequency of surgical events.We found antihuman leucocytes antigen antibodies in 40% of the patients.
CONCLUSION


No clinical benefit was found in this trial. This may have been related to graft rejection. Ectopia and high track number negatively influence the graft outcome. Procedural adjustments substantially improved surgical safety. (ClinicalTrials.gov NCT00190450.) © 2020 International Parkinson and Movement Disorder Society.",2020,"Mean total motor score at month 32 did not differ between groups (treated controls difference in means adjusted for M12: +2.9 [95% confidence interval, -2.8 to 8.6]; P = 0.31).","[""Huntington's Disease"", ""Patients at the early stage of the disease were enrolled in the Multicentric Intracerebral Grafting in Huntington's Disease trial, a delayed-start phase II randomized study"", '54 randomized patients', '40% of the patients']",['Human Fetal Cell Therapy'],"['total motor score', 'antihuman leucocytes antigen antibodies', 'surgical safety', 'frequency of surgical events', 'Mean total motor score', 'clinical, imaging, and electrophysiological findings and a comparison of pregraft and postgraft total motor score slopes']","[{'cui': 'C0020179', 'cui_str': ""Huntington's chorea""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439743', 'cui_str': 'Multicentric'}, {'cui': 'C0442111', 'cui_str': 'Intracerebral'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0439170', 'cui_str': '% fetal cells'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023516', 'cui_str': 'Leukocyte'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}]",54.0,0.162444,"Mean total motor score at month 32 did not differ between groups (treated controls difference in means adjusted for M12: +2.9 [95% confidence interval, -2.8 to 8.6]; P = 0.31).","[{'ForeName': 'Anne-Catherine', 'Initials': 'AC', 'LastName': 'Bachoud-Lévi', 'Affiliation': ""Assistance Publique-Hôpitaux de Paris, National Reference Center for Huntington's Disease, Neurology Department, Henri Mondor-Albert Chenevier Hospital, Créteil, France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28201']
1418,32647911,Single-Inhaler Triple Therapy and Health-Related Quality of Life in COPD: The IMPACT Study.,"INTRODUCTION


The phase 3 InforMing the PAthway of COPD (chronic obstructive pulmonary disease) Treatment (IMPACT) trial, single-inhaler therapy with fluticasone furoate (FF) 100 μg, umeclidinium (UMEC) 62.5 μg, and vilanterol (VI) 25 μg demonstrated a reduction in the rate of moderate or severe exacerbations compared with FF/VI or UMEC/VI in patients with symptomatic COPD at risk of exacerbations. This article reports additional evidence of improvements in symptoms and health-related quality of life (HRQoL) with FF/UMEC/VI compared with either FF/VI or UMEC/VI from the IMPACT study.
METHODS


Patient-reported HRQoL assessments and symptom measures included as pre-specified IMPACT end points were the St George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Baseline Dyspnea Index (BDI) as the anchor for the Transitional Dyspnea Index (TDI) focal score (BDI/TDI) in a subset of patients enrolled at study sites in North America and Europe. Change from baseline was assessed at weeks 4, 28, and 52.
RESULTS


The intent-to-treat population included 10,355 patients (TDI population: 5058 patients). Clinically meaningful improvements in SGRQ total score between baseline and week 52 favored FF/UMEC/VI over FF/VI (- 1.8 units, p < 0.001) and UMEC/VI (- 1.8 units, p < 0.001). Similar improvements in the CAT and TDI focal score were also observed with FF/UMEC/VI versus FF/VI or UMEC/VI.
CONCLUSIONS


This study demonstrates that in patients with symptomatic COPD at risk of exacerbations, once-daily FF/UMEC/VI, compared with FF/VI or UMEC/VI, improves patient-perceived HRQoL and symptoms.
TRIAL REGISTRATION NUMBER


NCT02164513.",2020,Clinically meaningful improvements in SGRQ total score between baseline and week 52 favored FF/UMEC/VI over FF/VI,"['10,355 patients (TDI population: 5058 patients', 'COPD', 'patients enrolled at study sites in North America and Europe', 'patients with symptomatic COPD at risk of exacerbations']","['fluticasone furoate (FF) 100\xa0μg, umeclidinium (UMEC) 62.5\xa0μg, and vilanterol (VI']","[""St George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Baseline Dyspnea Index (BDI) as the anchor for the Transitional Dyspnea Index (TDI) focal score (BDI/TDI"", 'SGRQ total score', 'rate of moderate or severe exacerbations', 'CAT and TDI focal score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3661274', 'cui_str': 'umeclidinium'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",10355.0,0.664861,Clinically meaningful improvements in SGRQ total score between baseline and week 52 favored FF/UMEC/VI over FF/VI,"[{'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Tabberer', 'Affiliation': 'GlaxoSmithKline plc, Stockley Park West, Uxbridge, Middlesex, UK. margaret.x.tabberer@gsk.com.'}, {'ForeName': 'C Elaine', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': 'GlaxoSmithKline plc, Research Triangle Park, NC, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kilbride', 'Affiliation': 'GlaxoSmithKline plc, Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lomas', 'Affiliation': 'UCL Respiratory, University College London, London, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Pascoe', 'Affiliation': 'GlaxoSmithKline plc, Collegeville, PA, USA.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'The Centre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'The Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lange', 'Affiliation': 'University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'The Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'University of Michigan, Pulmonary and Critical Care, Ann Arbor, MI, USA.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Morrys C', 'Initials': 'MC', 'LastName': 'Kaisermann', 'Affiliation': 'GlaxoSmithKline plc, Collegeville, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GlaxoSmithKline plc, Collegeville, PA, USA.'}]",Advances in therapy,['10.1007/s12325-020-01409-8']
1419,32648474,Predictors and Clinical Outcomes of Crossover From Radial to Femoral Access During Primary Percutaneous Coronary Intervention.,"Access site complications are more common with femoral access (FA) than radial access (RA). However, due to the higher rate of failure and crossover, door-to-balloon time (DBT) is prolonged by RA. Records of 3600 patients who underwent primary percutaneous coronary intervention (pPCI) between January 2016 and June 2019 were retrospectively reviewed. A total of 130 patients with crossover from RA to FA were identified and compared with the data of 501 patients who underwent pPCI with successful RA during 2018. Regression analysis was performed to determine the predictors of crossover. Crossover to the femoral approach occurred in 5.9% of our cases. Mean DBT was 17 minutes longer in the crossover group (61 ± 72 minutes vs 78 ± 79 minutes,  P  = .026). Female sex (odds ratio [OR]: 1.8; 95% CI, 0.99-3.46,  P  = .046) and anterior myocardial infarction (AntMI; OR: 0.52; 95% CI, 0.33-0.88,  P  = .007) were independent predictors of crossover. In-hospital mortality rates were significantly higher in the crossover group than in the radial success group (5.4% vs 1.8%,  P  = .020). Crossover to FA due to radial failure is associated with delayed DBT and increased rate of in-hospital mortality. Female sex and AntMI were primary predictors of crossover.",2020,"Mean DBT was 17 minutes longer in the crossover group (61 ± 72 minutes vs 78 ± 79 minutes,  P  = .026).","['3600 patients who underwent primary percutaneous coronary intervention (pPCI) between January 2016 and June 2019 were retrospectively reviewed', '130 patients with crossover from RA to FA were identified and compared with the data of 501 patients who underwent pPCI with successful RA during 2018', 'Female sex (odds ratio ']",['Crossover From Radial to Femoral Access'],"['rate of in-hospital mortality', 'hospital mortality rates', 'anterior myocardial infarction', 'Mean DBT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]","[{'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0444454', 'cui_str': 'Access'}]","[{'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0340293', 'cui_str': 'Myocardial Infarction, Anterior Wall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0557698', 'cui_str': 'Door'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",130.0,0.0870107,"Mean DBT was 17 minutes longer in the crossover group (61 ± 72 minutes vs 78 ± 79 minutes,  P  = .026).","[{'ForeName': 'Salih', 'Initials': 'S', 'LastName': 'Şahinkuş', 'Affiliation': 'Cardiology Department, 175679Sakarya University Education and Research Hospital, Sakarya, Turkey.'}, {'ForeName': 'Muhammet Necati Murat', 'Initials': 'MNM', 'LastName': 'Aksoy', 'Affiliation': 'Cardiology Department, 175679Sakarya University Education and Research Hospital, Sakarya, Turkey.'}, {'ForeName': 'Ercan', 'Initials': 'E', 'LastName': 'Aydin', 'Affiliation': 'Cardiology Department, Vakfıkebir State Hospital, Trabzon, Turkey.'}]",Angiology,['10.1177/0003319720940128']
1420,32648810,Efficacy and safety of brexpiprazole in patients with schizophrenia presenting with severe symptoms:  Post-hoc  analysis of short- and long-term studies.,"BACKGROUND


The treatment of patients with severe schizophrenia symptoms can be complicated and expensive.
AIMS


The purpose of this study was to evaluate the short- and long-term effects of brexpiprazole in patients with schizophrenia presenting with severe symptoms.
METHODS


Data were pooled from three six-week, randomized, double-blind, placebo-controlled studies and two 52-week, open-label extension studies. In the short-term studies, 1405 patients received placebo or brexpiprazole 2-4 mg/day; 412 brexpiprazole-treated patients rolled over into the long-term studies and received brexpiprazole 1-4 mg/day. More severe symptoms were defined as a Positive and Negative Syndrome Scale Total score >95 (median score at baseline). Outcomes included change in Positive and Negative Syndrome Scale Total and Personal and Social Performance scale scores.
RESULTS


Brexpiprazole improved Positive and Negative Syndrome Scale Total score over 6 weeks among more severely ill patients, with a least squares mean difference versus placebo of -6.76 (95% confidence limits: -9.80, -3.72;  p <0.0001; Cohen's  d : 0.43). Brexpiprazole also improved Personal and Social Performance scale score over 6 weeks in more severely ill patients (least squares mean difference: 4.38; limits: 2.14, 6.62;  p =0.0001; Cohen's  d : 0.38). Improvement of functioning was greatest in the 'Self-care' domain, followed by 'Personal and social relationships'. Among less severely ill patients, brexpiprazole was superior to placebo on Positive and Negative Syndrome Scale Total and Personal and Social Performance scale at Week 6. Improvements were maintained over 58 weeks. No new safety or tolerability concerns were observed.
CONCLUSIONS


Brexpiprazole is an efficacious and well-tolerated treatment for schizophrenia in patients with more severe, and less severe, symptoms.",2020,"Among less severely ill patients, brexpiprazole was superior to placebo on Positive and Negative Syndrome Scale Total and Personal and Social Performance scale at Week 6.","['patients with schizophrenia presenting with severe symptoms', '1405 patients received', 'patients with severe schizophrenia symptoms']","['brexpiprazole-treated patients rolled over into the long-term studies and received brexpiprazole 1-4 mg/day', 'Brexpiprazole', 'brexpiprazole', 'placebo or brexpiprazole', 'placebo']","['change in Positive and Negative Syndrome Scale Total and Personal and Social Performance scale scores', 'Positive and Negative Syndrome Scale Total and Personal and Social Performance scale', 'Personal and Social Performance scale score', 'severe symptoms', 'Efficacy and safety', 'Positive and Negative Syndrome Scale Total score', 'new safety or tolerability concerns']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C3885614', 'cui_str': 'brexpiprazole'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543436', 'cui_str': 'Does roll over'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205314', 'cui_str': 'New'}]",1405.0,0.236428,"Among less severely ill patients, brexpiprazole was superior to placebo on Positive and Negative Syndrome Scale Total and Personal and Social Performance scale at Week 6.","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Meade', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, USA.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, USA.'}, {'ForeName': 'Stine R', 'Initials': 'SR', 'LastName': 'Meehan', 'Affiliation': 'H. Lundbeck A/S, Valby, Copenhagen, Denmark.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Weiss', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, USA.'}, {'ForeName': 'Zahinoor', 'Initials': 'Z', 'LastName': 'Ismail', 'Affiliation': 'Department of Psychiatry and Hotchkiss Brain Institute, University of Calgary, Calgary, Canada.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120936485']
1421,32645683,Eye tracking of smoking-related stimuli in tobacco use disorder: A proof-of-concept study combining attention bias modification with alpha-transcranial alternating current stimulation.,"BACKGROUND


Tobacco use disorder (TUD) is characterized by the presence of an attentional bias (AB) towards smoking-related stimuli. We investigated whether combining an AB modification paradigm (ABM) with transcranial alternating current stimulation (tACS) applied over the dorsolateral prefrontal cortex (DLPFC) reduces the AB towards smoking-related stimuli, as well as craving level and impulsive choices.
METHODS


In a sham-controlled, crossover preliminary study, 19 subjects with TUD received two stimulation arms: 1) active tACS (10 Hz, 2 mA, 30 min) combined with ABM and 2) sham tACS combined with ABM, in a randomized order, separated by one week. AB towards smoking cues during passive observation of smoking and neutral cues was assessed with an eye-tracking device and reactions times at a visual-probe task. Craving level was measured with the Questionnaire of Smoking Urges. Impulsive choices were assessed with the delay discounting task.
RESULTS


Active tACS combined with ABM reduced the amount of time spent looking at smoking-related pictures (p = 0.03), prevented the increase of self-reported desire to smoke (p = 0.026), and reduced the proportion of impulsive choices (p = 0.049), compared to sham tACS combined with ABM. No significant effects were reported on other craving dimensions and on AB based on reaction times.
CONCLUSIONS


These preliminary findings suggest that combining tACS with ABM may help smokers who wish to quit by reducing the desire to smoke, attention to smoking-cues, and impulsive decision-making.",2020,"RESULTS


Active tACS combined with ABM reduced the amount of time spent looking at smoking-related pictures (p = 0.03), prevented the increase of self-reported desire to smoke (p = 0.026), and reduced the proportion of impulsive choices (p = 0.049), compared to sham tACS combined with ABM.","['19 subjects with TUD received two stimulation arms: 1', 'tobacco use disorder']","['tACS with ABM', 'alpha-transcranial alternating current stimulation', 'active tACS (10 Hz, 2 mA, 30 min) combined with ABM and 2) sham tACS combined with ABM', 'AB modification paradigm (ABM) with transcranial alternating current stimulation (tACS']","['Impulsive choices', 'increase of self-reported desire to smoke', 'delay discounting task', 'proportion of impulsive choices', 'craving dimensions and on AB based on reaction times', 'Craving level', 'time spent looking at smoking-related pictures']","[{'cui': 'C0040336', 'cui_str': 'Tobacco abuse'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}]","[{'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C3850035', 'cui_str': 'Intertemporal Preferences'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}]",19.0,0.0484381,"RESULTS


Active tACS combined with ABM reduced the amount of time spent looking at smoking-related pictures (p = 0.03), prevented the increase of self-reported desire to smoke (p = 0.026), and reduced the proportion of impulsive choices (p = 0.049), compared to sham tACS combined with ABM.","[{'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Mondino', 'Affiliation': ""Department of Psychiatry and Neurosciences, Medical School, Université Laval, CERVO Brain Research Center, Centre intégré universitaire en santé et services sociaux de la Capitale-Nationale, 2325 rue de l'Université, Quebec City, QC, G1V 0A6, Canada.""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lenglos', 'Affiliation': ""Department of Psychiatry and Neurosciences, Medical School, Université Laval, CERVO Brain Research Center, Centre intégré universitaire en santé et services sociaux de la Capitale-Nationale, 2325 rue de l'Université, Quebec City, QC, G1V 0A6, Canada.""}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Cinti', 'Affiliation': ""Department of Psychiatry and Neurosciences, Medical School, Université Laval, CERVO Brain Research Center, Centre intégré universitaire en santé et services sociaux de la Capitale-Nationale, 2325 rue de l'Université, Quebec City, QC, G1V 0A6, Canada.""}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Renauld', 'Affiliation': ""Department of Psychiatry and Neurosciences, Medical School, Université Laval, CERVO Brain Research Center, Centre intégré universitaire en santé et services sociaux de la Capitale-Nationale, 2325 rue de l'Université, Quebec City, QC, G1V 0A6, Canada.""}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Fecteau', 'Affiliation': ""Department of Psychiatry and Neurosciences, Medical School, Université Laval, CERVO Brain Research Center, Centre intégré universitaire en santé et services sociaux de la Capitale-Nationale, 2325 rue de l'Université, Quebec City, QC, G1V 0A6, Canada. Electronic address: shirley.fecteau@fmed.ulaval.ca.""}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108152']
1422,32650261,Efficacy and safety of systemic tranexamic acid administration in total knee arthroplasty: A case series.,"INTRODUCTION


Total knee arthroplasty (TKA) are associated with significant postoperative blood loss. Tranexamic acid (TXA) is a potent agent with antifibrinolytic activity, that can be administered via the intravenous (IV) and/or topical (intra-articular, IA) route, which can possibly interrupt the cascade of events due to hemostatic irregularities close to the source of bleeding. However, the literature contains scarce scientific evidence related to IV only TXA usage in TKA. The current study aims to compare the outcome between patients who were administered IV TXA and a control group in terms of blood loss, transfusion rate, and incidence of deep vein thrombosis (DVT) and thromboembolism (TE).
METHODS


110 patients, who underwent TKA were placed into two groups: 1) 34 patients who received IV TXA; and 2) 76 patients in the control group. In the TXA group, patients received an IV TXA dose of 1 g, 30 min before incision. Two drains were placed.
RESULTS


Usage of IV TXA showed better results when compared to the control group in terms of mean blood transfusion (0.5 less transfusion during hospital stay), hemoglobin drop (10%). No cases of DVT or TE were noted among the two study groups.
CONCLUSION


Use of IV TXA provided significantly better results compared to no TXA use with respect to all variables related to postoperative blood loss in TKA. Moreover, TXA use is safe in terms of incidence of symptomatic DVT and TE.",2020,Use of IV TXA provided significantly better results compared to no TXA use with respect to all variables related to postoperative blood loss in TKA.,"['total knee arthroplasty', '110 patients, who underwent TKA were placed into two groups: 1) 34 patients who received']","['IV TXA', 'TXA', 'systemic tranexamic acid', 'Tranexamic acid (TXA', 'Total knee arthroplasty (TKA']","['mean blood transfusion', 'DVT or TE', 'Efficacy and safety', 'blood loss, transfusion rate, and incidence of deep vein thrombosis (DVT) and thromboembolism (TE']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",110.0,0.0314014,Use of IV TXA provided significantly better results compared to no TXA use with respect to all variables related to postoperative blood loss in TKA.,"[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Maalouly', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Josephmaalouly2@gmail.com.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'El Assaad', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Donna.elassaad@lau.edu.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Ayoubi', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: rami.ayoubi1@gmail.com.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Tawk', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Antoniostawk@gmail.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Darwish', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Mohammaddarwish2@gmail.com.'}, {'ForeName': 'Dany', 'Initials': 'D', 'LastName': 'Aouad', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Dany_aouad@hotmail.com.'}, {'ForeName': 'Georgio', 'Initials': 'G', 'LastName': 'Lati', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Georgio.lati@gmail.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Darwish', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Mohammaddarwish2@gmail.com.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'El Rassi', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: gselrassi@gmail.com.'}]",International journal of surgery case reports,['10.1016/j.ijscr.2020.06.077']
1423,32652064,Validation of an enhanced recovery after surgery protocol in gynecologic surgery: an Italian randomized study.,"BACKGROUND


The enhanced recovery after surgery concept, which was introduced 20 years ago, is based on a multimodal approach to improve the functional rehabilitation of patients after surgery.
OBJECTIVE


This study aimed to validate an enhanced recovery after surgery protocol in gynecologic surgery for both benign and malignant diseases (endometrial cancer and advanced ovarian cancer) and to measure the adherence to the enhanced recovery after surgery protocol items in a randomized trial setting.
STUDY DESIGN


In this trial (NCT03347409), we randomly assigned patients to undergo standard perioperative care or enhanced recovery after surgery protocol. The primary outcome is a shorter length of stay in favor of the enhanced recovery after surgery protocol. Secondary outcomes include measurement of adherence to the enhanced recovery after surgery protocol items: comparison of postoperative pain, vomiting, and nausea; anesthesiologic and surgical complications up to 30 days after surgery; rate of readmissions; the time to event in hours for bowel movements, flatus, drinking, hunger, eating, and walking; and the quality of recovery using a validated questionnaire (QoR-15). Finally, we explored the length of stay in the prespecified subgroups at randomization, based on the type of surgical access and gynecologic disease.
RESULTS


A total of 168 women were available for analysis: 85 women (50.6%) were assigned to the standard perioperative care group, and 83 women (49.4%) were assigned to the enhanced recovery after surgery protocol group. The 2 groups were similar for age, body mass index, comorbidities, anesthesiological risk, smoking habits, surgical access, and complexity of surgical procedures. Seventy-two patients (42.9%) underwent surgery for benign disease, 48 (28.6%) for endometrial cancer, and 48 (28.6%) for ovarian cancer. Women in the enhanced recovery after surgery protocol group had a shorter length of stay (median: 2 [interquartile range, 2-3] vs 4 [interquartile range, 4-7] days; P<.001). A decreased rate of postoperative complications was noted for the enhanced recovery after surgery protocol group, as well as an earlier time to occur for all the events. Mean adherence to protocol items was 84.8% (95% confidence interval, 79.7-89.8), and we registered a better satisfaction in the enhanced recovery after surgery protocol group. The shortening of the length of stay was confirmed also in the prespecified subgroup analysis.
CONCLUSION


Application of the enhanced recovery after surgery protocol in gynecologic surgery translated to a shorter length of stay regardless of surgical access and type of gynecologic disease. Adherence to the enhanced recovery after surgery protocol items in the setting of a randomized trial was high.",2020,"The two groups were similar for age, BMI, comorbidities, anesthesiological risk, smoking habits, surgical access and complexity of surgical procedures.","['gynecological surgery', 'gynecological surgery both for benign and malignant disease (endometrial cancer and advanced ovarian cancer', 'A total of 168 women were available for analysis, of them 85 (50.6%) underwent standard perioperative care while 83 (49.4%) were assigned to']","['ERAS protocol', 'standard perioperative care or ERAS protocol', 'ERAS', 'surgery (ERAS) protocol']","['shortening of the length of stay', 'Mean adherence to protocol items', 'shorter length of stay in favor of ERAS', 'shorter length of stay, regardless of surgical access and type of gynecological disease', 'measurement of adherence to ERAS items, comparison of postoperative pain, vomiting and nausea, anesthesiological and surgical complications up to thirty days after surgery, rate of readmissions, the time-to-event in hours for bowel movements, flatus, drink, hunger, eating and walking and lastly the quality of recovery using a validated questionnaire (QoR 15', 'shorter length of stay', 'rate of postoperative complications']","[{'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150706', 'cui_str': 'Perioperative care'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150706', 'cui_str': 'Perioperative care'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0017411', 'cui_str': 'Disorder of female genital organs'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",168.0,0.160542,"The two groups were similar for age, BMI, comorbidities, anesthesiological risk, smoking habits, surgical access and complexity of surgical procedures.","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Ferrari', 'Affiliation': 'Department of Obstetrics and Gynecology, Spedali Civili, Brescia, Italy. Electronic address: f.ferrari.obgyn@gmail.com.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Forte', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Sbalzer', 'Affiliation': 'Department of Anesthesia, Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Zizioli', 'Affiliation': 'Department of Obstetrics and Gynecology, Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Mauri', 'Affiliation': 'Department of Obstetrics and Gynecology, Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Maggi', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Sartori', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Odicino', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Brescia, Brescia, Italy.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.07.003']
1424,32652557,Metamizole but not ibuprofen reduces the plasma concentration of sertraline: Implications for the concurrent treatment of pain and depression/anxiety disorders.,"AIM


Comorbidity of pain and depression or anxiety is a challenging clinical phenomenon, often requiring the concurrent application of antidepressant and analgesic drugs. Growing evidence suggests that the analgesic metamizole exhibits cytochrome P450 inducing properties. In the present study, we assessed the impact of metamizole and ibuprofen on plasma concentrations of the selective serotonin reuptake inhibitor sertraline.
METHODS


Out of a therapeutic drug monitoring (TDM) database, three groups of patients were compared: patients receiving sertraline and metamizole (n = 15), patients receiving sertraline and ibuprofen (n = 19), and a matched control group without one of the analgesics (n = 19).
RESULTS


Metamizole was associated with 67% lower median sertraline plasma concentrations compared to the control group (14 vs 42 ng/mL, P < 0.001). In contrast, differences between the ibuprofen group and the control group did not reach statistical significance (31 vs 42 ng/mL, P = 0.128). Moreover, the metamizole group demonstrated lower dose-adjusted drug concentrations than the ibuprofen group (0.10 vs 0.26 (ng/mL)/(mg/day), P = 0.008). Finally, the metamizole group exhibited a higher proportion of patients whose sertraline concentrations were below the therapeutic reference range (40% in the metamizole group, 5% in the ibuprofen group, 0% in the control group, P = 0.005) indicating therapeutically insufficient drug concentrations.
CONCLUSION


Our findings support preliminary evidence that metamizole acts as a potent inductor of cytochrome P450 isoenzymes CYP2B6 and CYP3A4. We observed a clinically meaningful pharmacokinetic interaction between metamizole and sertraline, leading to insufficiently low sertraline drug concentrations. Clinicians should therefore consider alternative drug combinations or apply TDM-guided dose adjustment of sertraline.",2020,"RESULTS


Metamizole was associated with 67% lower median sertraline plasma concentrations compared to the control group (14 vs. 42 ng/mL; p<0.001).",['n=19) and a matched control group without one of the analgesics (n=19'],"['sertraline', 'Ibuprofen', 'sertraline and ibuprofen', 'sertraline and metamizole', 'metamizole and ibuprofen', 'ibuprofen']","['lower dose-adjusted drug concentrations', 'plasma concentration', 'sertraline concentrations', 'median sertraline plasma concentrations']","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0012586', 'cui_str': 'Dipyrone'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.045651,"RESULTS


Metamizole was associated with 67% lower median sertraline plasma concentrations compared to the control group (14 vs. 42 ng/mL; p<0.001).","[{'ForeName': 'Arnim Johannes', 'Initials': 'AJ', 'LastName': 'Gaebler', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Schoretsanitis', 'Affiliation': 'Psychiatry Research, Northwell Health, The Zucker Hillside Hospital, Glen Oaks, New York, USA.'}, {'ForeName': 'Nagia', 'Initials': 'N', 'LastName': 'Ben Omar', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Clinical Pharmacology, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Ekkehard', 'Initials': 'E', 'LastName': 'Haen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Clinical Pharmacology, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Endres', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Clinical Pharmacology, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Hiemke', 'Affiliation': 'Department of Psychiatry and Psychotherapy and Institute of Clinical Chemistry and Laboratory Medicine, University Medical Center of Mainz, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Paulzen', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, RWTH Aachen, Aachen, Germany.'}]",British journal of clinical pharmacology,['10.1111/bcp.14471']
1425,32656738,Dynamic Eye Tracking as a Predictor and Outcome Measure of Social Skills Intervention in Adolescents and Adults with Autism Spectrum Disorder.,"To evaluate an eye tracking task as a predictor and outcome measure of treatment response for autism spectrum disorder (ASD) social skills interventions, adolescents and young adults with ASD completed the eye tracking task before, immediately after, and two months after completing Social Cognition and Interaction Training for Autism (SCIT-A). The study compared SCIT-A participants (n = 20) to participants with ASD who received treatment as usual (TAU; n = 21). Overall, increased visual attention to faces and background objects and decreased attention to hands playing with toys at baseline were associated with improved social functioning immediately following intervention, suggesting this eye tracking task may reliably predict ASD social intervention outcomes.",2020,"Overall, increased visual attention to faces and background objects and decreased attention to hands playing with toys at baseline were associated with improved social functioning immediately following intervention, suggesting this eye tracking task may reliably predict ASD social intervention outcomes.","['Adolescents and Adults with Autism Spectrum Disorder', 'autism spectrum disorder (ASD) social skills interventions, adolescents and young adults with ASD']",['Social Skills Intervention'],"['visual attention to faces and background objects and decreased attention to hands playing with toys', 'social functioning']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0589102', 'cui_str': 'Visual attention'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0040565', 'cui_str': 'Toy'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}]",,0.0620067,"Overall, increased visual attention to faces and background objects and decreased attention to hands playing with toys at baseline were associated with improved social functioning immediately following intervention, suggesting this eye tracking task may reliably predict ASD social intervention outcomes.","[{'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Greene', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Parish-Morris', 'Affiliation': ""Center for Autism Research, Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.""}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Sullivan', 'Affiliation': 'Carolina Institute for Developmental Disabilities, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Kinard', 'Affiliation': 'Carolina Institute for Developmental Disabilities, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Maya G', 'Initials': 'MG', 'LastName': 'Mosner', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Turner-Brown', 'Affiliation': 'TEACCH Autism Program, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Penn', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Wiesen', 'Affiliation': 'The Odum Institute, The University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Ashley A', 'Initials': 'AA', 'LastName': 'Pallathra', 'Affiliation': 'Center for Neurobiology and Behavior, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Brodkin', 'Affiliation': 'Center for Neurobiology and Behavior, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Schultz', 'Affiliation': ""Center for Autism Research, Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.""}, {'ForeName': 'Gabriel S', 'Initials': 'GS', 'LastName': 'Dichter', 'Affiliation': 'Carolina Institute for Developmental Disabilities, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA. dichter@med.unc.edu.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04594-1']
1426,32653447,Effect of Dapagliflozin in Patients With HFrEF Treated With Sacubitril/Valsartan: The DAPA-HF Trial.,"OBJECTIVES


This study assessed the efficacy and safety of dapagliflozin in patients who were or were not taking sacubitril/valsartan at baseline in the DAPA-HF (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure) trial.
BACKGROUND


Both the angiotensin receptor neprilysin-inhibitor sacubitril/valsartan and the sodium glucose co-transporter 2 inhibitor dapagliflozin reduced cardiovascular death and heart failure (HF) hospitalization in patients with HF with reduced ejection fraction (HFrEF). Whether either of these classes of drugs influences the effectiveness or safety of the other remains unknown.
METHODS


DAPA-HF was a 4,744 patient trial that compared dapagliflozin with placebo in patients with HFrEF. Patients were analyzed according to whether they were taking sacubitril/valsartan at randomization. The efficacy of dapagliflozin on the primary composite outcome (CV death or episode of worsening heart failure), its components, and all-cause death was examined according to sacubitril/valsartan and the interaction tested. Predefined safety outcomes were examined by sacubitril/valsartan group.
RESULTS


A total of 508 patients (10.7%) enrolled in DAPA-HF were treated with sacubitril/valsartan at baseline. Patients prescribed sacubitril/valsartan were more likely to be from North America or Europe, to have lower ejection fractions and systolic and diastolic blood pressures, but were similar with respect to age, New York Heart Association functional class, history of diabetes, and use of other evidence-based HF therapies. The benefit of dapagliflozin compared with placebo was similar in patients taking sacubitril/valsartan (hazard ratio: 0.75; 95% confidence interval 0.50 to 1.13) compared with those not taking sacubitril/valsartan (hazard ratio: 0.74; 95% confidence interval 0.65 to 0.86) for the primary endpoint of cardiovascular death or worsening HF; similar findings were observed for secondary endpoints. All measures of safety, including episodes related to hypovolemia, were similar among patients randomized to dapagliflozin or placebo, whether they received background sacubitril/valsartan.
CONCLUSIONS


Dapagliflozin was similarly efficacious and safe in patients who were and who were not taking sacubitril/valsartan in the DAPA-HF trial, which suggested that the use of both agents together could further lower morbidity and mortality in patients with HFrEF. (Dapagliflozin And Prevention of Adverse outcomes in Heart Failure [DAPA-HF]; NCT03036124).",2020,"All measures of safety, including episodes related to hypovolemia, were similar among patients randomized to dapagliflozin or placebo, whether they received background sacubitril/valsartan.
","['patients with HF with reduced ejection fraction (HFrEF', '508 patients (10.7%) enrolled in DAPA-HF were treated with', 'Patients With HFrEF', 'DAPA-HF was a 4,744 patient trial that compared', 'patients who were and who were not taking sacubitril', 'patients with HFrEF', 'patients who were or were not taking sacubitril/valsartan at baseline in the DAPA-HF (Study to Evaluate the Effect of', 'Patients With Chronic Heart Failure) trial']","['dapagliflozin or placebo', 'valsartan', 'dapagliflozin with placebo', 'dapagliflozin', 'background sacubitril/valsartan', 'Dapagliflozin', 'sacubitril/valsartan', 'Sacubitril/Valsartan', 'placebo']","['cardiovascular death', 'primary composite outcome (CV death or episode of worsening heart failure), its components, and all-cause death', 'efficacy and safety', 'cardiovascular death and heart failure (HF) hospitalization', 'ejection fractions and systolic and diastolic blood pressures', 'morbidity and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C5191365', 'cui_str': '10.7'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4033447', 'cui_str': 'sacubitril'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",508.0,0.140024,"All measures of safety, including episodes related to hypovolemia, were similar among patients randomized to dapagliflozin or placebo, whether they received background sacubitril/valsartan.
","[{'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: ssolomon@bwh.harvard.edu.""}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, Scotland.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Dewan', 'Affiliation': 'BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, Scotland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Riggshospital, Copenhagen, Denmark.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""St. Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Kansas.""}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'Universidad Nacional de Córdoba, Córdoba, Argentina.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Center for Heart Diseases, University Hospital, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University Medical School, New Haven, Connecticut.'}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lindholm', 'Affiliation': 'Section of Endocrinology, Yale University Medical School, New Haven, Connecticut.'}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjostrand', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, Scotland.'}]",JACC. Heart failure,['10.1016/j.jchf.2020.04.008']
1427,32654212,mNIS+7 and lower limb function in inotersen treatment of hereditary transthyretin-mediated amyloidosis.,"INTRODUCTION


Inotersen, an antisense oligonucleotide inhibitor of transthyretin (TTR) protein production, demonstrated significant benefit versus placebo in the modified Neuropathy Impairment Score (NIS) +7 neurophysiologic tests (mNIS+7) in patients with hereditary TTR-mediated amyloidosis (hATTR) with polyneuropathy. This analysis assessed the mNIS+7 components by anatomic location and the lower limb function (LLF) test.
METHODS


Adults with hATTR in the NEURO-TTR trial (NCT01737398) were randomly assigned to receive weekly doses of subcutaneous inotersen 300 mg or placebo for 65 weeks. The mNIS+7 and LLF were assessed at 35 and 66 weeks.
RESULTS


All major mNIS+7 components (muscle weakness, muscle stretch reflexes, sensation) and the LLF showed significant efficacy in patients receiving inotersen versus placebo; however, NIS-reflexes (upper limb), touch pressure (upper and lower limbs), and heart rate during deep breathing did not show significant effects.
DISCUSSION


The results of this analysis reinforce the beneficial effect of inotersen on slowing neuropathy progression in patients with hATTR polyneuropathy.",2020,"Inotersen, an antisense oligonucleotide inhibitor of TTR protein production, demonstrated significant benefit versus placebo in the modified Neuropathy Impairment Score +7 neurophysiologic tests (mNIS+7) in patients with hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy.","['Adults with hATTR', 'patients with hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy', 'patients with hATTR polyneuropathy']","['subcutaneous inotersen 300 mg or placebo', 'placebo']","['All major mNIS+7 components (muscle weakness, muscle stretch reflexes, sensation', 'mNIS+7 and LLF', 'Mnis+7 And Lower Limb Function', 'NIS-reflexes (upper limb), touch pressure (upper and lower limbs), and heart rate deep breathing']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002726', 'cui_str': 'Amyloidosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0206247', 'cui_str': 'Polyneuropathy in amyloidosis'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4731850', 'cui_str': 'inotersen'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C0407178', 'cui_str': 'Stretching of muscle'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1504824', 'cui_str': 'SLC5A5 protein, human'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1321587', 'cui_str': 'Excessively deep breathing'}]",,0.124471,"Inotersen, an antisense oligonucleotide inhibitor of TTR protein production, demonstrated significant benefit versus placebo in the modified Neuropathy Impairment Score +7 neurophysiologic tests (mNIS+7) in patients with hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy.","[{'ForeName': 'P James B', 'Initials': 'PJB', 'LastName': 'Dyck', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Kincaid', 'Affiliation': 'Department of Neurology, Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Janice F', 'Initials': 'JF', 'LastName': 'Wiesman', 'Affiliation': 'Department of Neurology, New York University, New York, New York, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Polydefkis', 'Affiliation': 'Department of Neurology, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Litchy', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Mauermann', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Ackermann', 'Affiliation': 'Otonomy, Inc., San Diego, California, USA.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Guthrie', 'Affiliation': 'Aurora Bio, San Francisco, California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pollock', 'Affiliation': 'Akcea Therapeutics, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Shiangtung W', 'Initials': 'SW', 'LastName': 'Jung', 'Affiliation': 'Ionis Pharmaceuticals, Inc., Carlsbad, California, USA.'}, {'ForeName': 'Brenda F', 'Initials': 'BF', 'LastName': 'Baker', 'Affiliation': 'Ionis Pharmaceuticals, Inc., Carlsbad, California, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Dyck', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}]",Muscle & nerve,['10.1002/mus.27022']
1428,32659247,Children overcoming picky eating (COPE) - A cluster randomised controlled trial.,"OBJECTIVES


Food neophobia limits dietary variety in children and adults. Interventions to alleviate the impact of neophobia on children's dietary variety have had varying success. The potential effectiveness of mindfulness, a process of bringing awareness to the present moment, has received little attention. This trial aimed to explore the effectiveness of two mindfulness exercises on novel food acceptance for children.
METHODS


A cluster-randomised controlled trial with three trial arms compared the impact of two mindfulness exercises (mindful breathing and mindful raisin-eating) and a non-mindful control task on anticipated liking and intake of a novel fruit. Seventy-one children aged 10-12 years engaged in one of the three tasks at school over five days and were offered a novel fruit at the end of the intervention. Children self-reported mindfulness, food neophobia and anxiety at baseline and follow-up.
RESULTS


Two mixed-effects models showed that, controlling for school effects and covariates (including mindfulness, food neophobia and anxiety), children in the mindful raisin-eating arm reported greater anticipated liking of a novel fruit and children in both mindfulness arms consumed greater amounts of a novel fruit than children in the control arm. Mixed-design ANOVAs indicated that mindfulness, food neophobia and anxiety did not change over time in each trial arm.
CONCLUSIONS


The results provide promising evidence for the potential effectiveness of mindfulness interventions in encouraging children to try new foods. The mechanisms underlying effectiveness remain unclear and further research, exploring long-term effects and the possibility to generalise these findings to other food groups such as vegetables, is needed.",2020,"Mixed-design ANOVAs indicated that mindfulness, food neophobia and anxiety did not change over time in each trial arm.
","['children and adults', 'Children overcoming picky eating (COPE) ', 'Seventy-one children aged 10-12 years engaged in one of the three tasks at school over five days and were offered a novel fruit at the end of the intervention', 'children']","['mindfulness exercises (mindful breathing and mindful raisin-eating) and a non-mindful control task', 'mindfulness exercises']","['school effects and covariates (including mindfulness, food neophobia and anxiety', 'mindfulness, food neophobia and anxiety', 'Children self-reported mindfulness, food neophobia and anxiety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0453310', 'cui_str': 'Raisins'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3840121', 'cui_str': 'Avoidant restrictive food intake disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",71.0,0.0797824,"Mixed-design ANOVAs indicated that mindfulness, food neophobia and anxiety did not change over time in each trial arm.
","[{'ForeName': 'Carmel', 'Initials': 'C', 'LastName': 'Bennett', 'Affiliation': 'Birmingham and Solihull Mental Health NHS Foundation Trust, UK. Electronic address: carmelbennett@nhs.net.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Copello', 'Affiliation': 'Birmingham and Solihull Mental Health NHS Foundation Trust, UK; School of Psychology, University of Birmingham, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'School of Psychology, University of Birmingham, UK.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Blissett', 'Affiliation': 'Department of Psychology, School of Life and Health Sciences, Aston University, UK.'}]",Appetite,['10.1016/j.appet.2020.104791']
1429,32659699,A web-based daily care training to improve the quality of life of mothers of children with cerebral palsy: A randomized controlled trial.,"BACKGROUND


Mothers of moderately to severely affected children with cerebral palsy (CP) have to spend a long time to take care of their children. This time-consuming responsibility affects their physical and psychosocial health. Therefore, mothers as caregivers are required to receive special training to take care of their children.
AIMS


The aim of this study was to evaluate the effectiveness of a developed web-based intervention for daily care training of children with CP on their mothers' quality of life (QOL), anxiety, depression, stress, and their musculoskeletal pain.
METHODS AND PROCEDURES


This study was a single blind randomized controlled trial. 91 mothers of children with CP with Gross Motor Function Classification System (GMFCS) levels III, IѴ, and Ѵ, who aged from 4 to 12 years were assigned to the intervention and control groups using block randomization. Mothers in the control group received their routine face to face occupational therapy intervention and mothers in the intervention group received 12 weeks web-based intervention. QOL, depression, anxiety, stress, and pain were measured before and after the intervention in both groups.
OUTCOMES AND RESULTS


The results of analysis of covariance showed that after controlling the mean score of pretest of pain, the mean score of post-tests in the intervention and control groups was significantly different (P < 0.05). The mean scores of physical health and total QOL scores of post-tests in the intervention group were significantly higher than the control group with controlling pretest scores.
CONCLUSIONS AND IMPLICATIONS


Designed web-based intervention affects the caregivers' QOL and pain significantly. This intervention can be used to provide daily care training for mothers of children with CP.",2020,"The mean scores of physical health and total QOL scores of post-tests in the intervention group were significantly higher than the control group with controlling pretest scores.
","['91 mothers of children with CP with Gross Motor Function Classification System (GMFCS) levels III, IѴ, and Ѵ, who aged from 4 to 12 years', 'mothers of children with cerebral palsy', 'Mothers of moderately to severely affected children with cerebral palsy (CP', 'mothers of children with CP', 'children with CP on their mothers']","['special training', 'A web-based daily care training', 'routine face to face occupational therapy intervention and mothers in the intervention group received 12 weeks web-based intervention']","['quality of life', 'QOL, depression, anxiety, stress, and pain', 'mean score of pretest of pain', 'quality of life (QOL), anxiety, depression, stress, and their musculoskeletal pain', 'mean scores of physical health and total QOL scores of post-tests']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441927', 'cui_str': 'Level III'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",91.0,0.0560542,"The mean scores of physical health and total QOL scores of post-tests in the intervention group were significantly higher than the control group with controlling pretest scores.
","[{'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Nobakht', 'Affiliation': 'Pediatric Neurorehabilitation Research Center and Occupational Therapy Department, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rassafiani', 'Affiliation': 'Occupational Therapy Department, Faculty of Allied Health Sciences, Kuwait University, Kuwait. Pediatric Neurorehabilitation Research Center, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran. Electronic address: mrassafiani@yahoo.com.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Hosseini', 'Affiliation': 'Social Determinants of Health Research Center and Occupational Therapy Department, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hosseinzadeh', 'Affiliation': 'Biosatistics Department, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}]",Research in developmental disabilities,['10.1016/j.ridd.2020.103731']
1430,32659714,The effect of web-based training on life quality and spousal adjustment for women with breast cancer and their spouses.,"PURPOSE


The aim of the study was to examine the effects of web-based training that was structured in line with Roy's Adaptation Model on the ""life quality"" of women with breast cancer, and on the ""spousal adjustment"" of women and their spouses.
METHOD


The study used a pretest-posttest, quasi-experimental controlled group design and 83 women with breast cancer and their spouses were enrolled. The data were collected at baseline and again three months later using the Functional Assessment of Cancer Therapy-breast cancer scale and the Dyadic Adjustment Scale as data collection tools.
RESULTS


The average scores of life quality and agreement between spouses in the web-based training group were higher than in the control group. More specifically, the physical well-being (p=0.002), emotional well-being (p<0.001), functional well-being (p=0.001), breast cancer module scores (p<0.001) and dyadic cohesion (p=0.003) and dyadic consensus (p<0.001) sub-dimension scores of the women in the intervention group were higher than those in the control group in the third month. Similarly, the third month mean score of dyadic consensus (p<0.001) and affectional expression (p=0.023) of the spouses in the intervention group were higher than those in the control group.
CONCLUSIONS


The web-based training programme that was prepared by nurses in line with Roy's Adaptation Model improved the life quality and couples' adjustment in women with breast cancer. Web-based training can be used to improve patient care outcomes because of the continuity of training for women and their spouses.",2020,"Similarly, the third month mean score of dyadic consensus (p<0.001) and affectional expression (p=0.023) of the spouses in the intervention group were higher than those in the control group.
","['women with breast cancer', '83 women with breast cancer and their spouses were enrolled', 'women with breast cancer, and on the ""spousal adjustment"" of women and their spouses', 'women with breast cancer and their spouses']",['web-based training'],"['dyadic consensus (p<0.001) sub-dimension scores', 'life quality and spousal adjustment', 'Functional Assessment of Cancer Therapy-breast cancer scale and the Dyadic Adjustment Scale', 'life quality', 'average scores of life quality', 'emotional well-being (p<0.001), functional well-being (p=0.001), breast cancer module scores (p<0.001) and dyadic cohesion', 'mean score of dyadic consensus (p<0.001) and affectional expression']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",83.0,0.0223756,"Similarly, the third month mean score of dyadic consensus (p<0.001) and affectional expression (p=0.023) of the spouses in the intervention group were higher than those in the control group.
","[{'ForeName': 'Saadet', 'Initials': 'S', 'LastName': 'Çömez', 'Affiliation': 'Mehmet Akif Ersoy University, Faculty of Health Sciences, Department of Nursing, Burdur, Turkey. Electronic address: saadet.andic@gmail.com.'}, {'ForeName': 'Özgül', 'Initials': 'Ö', 'LastName': 'Karayurt', 'Affiliation': 'Izmir University of Economics, Faculty of Health Sciences, Department of Nursing, Izmir, Turkey.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2020.101758']
1431,32663699,A randomized control trial of activity scheduling for caring for older adults with dementia and its impact on their spouse care-givers.,"INTRODUCTION


Participating in meaningful activities is important for any individual's wellbeing. Activity scheduling enables older adults with dementia and their spouse caregivers to structure their activities in accordance with the things they value.
METHODS


In examining the effectiveness of activity scheduling, this report details the results of a 12-week single-blinded randomized control trial using a parallel group experimental design.
RESULTS


From August 2018 to August 2019, 100 community-dwelling older adults with mild to moderate dementia and their spouses completed this study. The experimental group (n = 50) practicing activity scheduling showed improvements than in control group (n = 50), with respect to alleviating the impact of the caregiving role, reducing the behavioural and psychological symptoms of dementia, decreasing the caring demand and generally improving the quality of life, with Cohen's d = .61, .45, .50 and 43 respectively. Moreover, there were significant differences between the groups indicated that over time, the experimental group showed an improvement with regard to alleviating the role of caring, with Cohen's d = .64, and alleviating disruptive and depressive behavior, with an effect size of .45 and .50 respectively. The number of caring hours needed dropped from 6.98 to 5.98 h in the experimental group.
DISCUSSION & CONCLUSION


There were more activities that older adults with dementia and their spouse caregivers would like to do, and could participate in, than we had expected. Activity scheduling can facilitate their participation. This is a very important topic as non-pharmacological interventions are needed for this even-growing segment of the population.",2020,"The experimental group (n = 50) practicing activity scheduling showed improvements than in control group (n = 50), with respect to alleviating the impact of the caregiving role, reducing the behavioural and psychological symptoms of dementia, decreasing the caring demand and generally improving the quality of life, with Cohen's d = .61, .45, .50 and 43 respectively.","['older adults with dementia and its impact on their spouse care-givers', 'older adults with dementia and their spouse caregivers', 'From August 2018 to August 2019, 100 community-dwelling older adults with mild to moderate dementia and their spouses completed this study']",[],"['number of caring hours needed', 'alleviating disruptive and depressive behavior']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0087015', 'cui_str': 'Spouse Caregivers'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0283988,"The experimental group (n = 50) practicing activity scheduling showed improvements than in control group (n = 50), with respect to alleviating the impact of the caregiving role, reducing the behavioural and psychological symptoms of dementia, decreasing the caring demand and generally improving the quality of life, with Cohen's d = .61, .45, .50 and 43 respectively.","[{'ForeName': 'Frank Ho-Yin', 'Initials': 'FH', 'LastName': 'Lai', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong. Electronic address: frank.hy.lai@polyu.edu.hk.'}, {'ForeName': 'Elaine Wai-Hung', 'Initials': 'EW', 'LastName': 'Yan', 'Affiliation': 'Occupational Therapy Department, Kowloon Hospital, Hong Kong.'}, {'ForeName': 'Wing-Sze', 'Initials': 'WS', 'LastName': 'Tsui', 'Affiliation': ""Chung Hok Elderly Centre, Women's Welfare Club Western District, Hong Kong.""}, {'ForeName': 'Kathy Ka-Ying', 'Initials': 'KK', 'LastName': 'Yu', 'Affiliation': 'Tai Po Integrated Service for Senior Citizens, The Salvation Army Hong Kong & Macau Command, Hong Kong.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104167']
1432,32664003,"Can personalized treatment prediction improve the outcomes, compared with the group average approach, in a randomized trial? Developing and validating a multivariable prediction model in a pragmatic megatrial of acute treatment for major depression.","BACKGROUND


Clinical trials have traditionally been analysed at the aggregate level, assuming that the group average would be applicable to all eligible and similar patients. We re-analyzed a mega-trial of antidepressant therapy for major depression to explore whether a multivariable prediction model may lead to different treatment recommendations for individual participants.
METHODS


The trial compared the second-line treatment strategies of continuing sertraline, combining it with mirtazapine or switching to mirtazapine after initial failure to remit on sertraline among 1,544 patients with major depression. The outcome was the Personal Health Questionnaire-9 (PHQ-9) at week 9: the original analyses showed that both combining and switching resulted in greater reduction in PHQ-9 by 1.0 point than continuing. We considered several models of penalized regression or machine learning.
RESULTS


Models using support vector machines (SVMs) provided the best performance. Using SVMs, continuing sertraline was predicted to be the best treatment for 123 patients, combining for 696 patients, and switching for 725 patients. In the last two subgroups, both combining and switching were equally superior to continuing by 1.2 to 1.4 points, resulting in the same treatment recommendations as with the original aggregate data level analyses; in the first subgroup, however, switching was substantively inferior to combining (-3.1, 95%CI: -5.4 to -0.5).
LIMITATIONS


Stronger predictors are needed to make more precise predictions.
CONCLUSIONS


The multivariable prediction models led to improved recommendations for a minority of participants than the group average approach in a megatrial.",2020,"In the last two subgroups, both combining and switching were equally superior to continuing by 1.2 to 1.4 points, resulting in the same treatment recommendations as with the original aggregate data level analyses; in the first subgroup, however, switching was substantively inferior to combining (-3.1, 95%CI: -5.4 to -0.5).
","['123 patients, combining for 696 patients, and switching for 725 patients', 'individual participants', '1,544 patients with major depression']","['support vector machines (SVMs', 'antidepressant therapy', 'mirtazapine or switching to mirtazapine']","['Personal Health Questionnaire-9 (PHQ-9', 'PHQ-9']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C2699740', 'cui_str': 'Support Vector Machine'}, {'cui': 'C1096649', 'cui_str': 'Antidepressant therapy'}, {'cui': 'C0049506', 'cui_str': 'Mirtazapine'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",1544.0,0.0523889,"In the last two subgroups, both combining and switching were equally superior to continuing by 1.2 to 1.4 points, resulting in the same treatment recommendations as with the original aggregate data level analyses; in the first subgroup, however, switching was substantively inferior to combining (-3.1, 95%CI: -5.4 to -0.5).
","[{'ForeName': 'Toshi A', 'Initials': 'TA', 'LastName': 'Furukawa', 'Affiliation': 'Departments of Health Promotion and Human Behavior and of Clinical Epidemiology, Kyoto University Graduate School of Medicine / School of Public Health, Kyoto, Japan. Electronic address: furukawa@kuhp.kyoto-u.ac.jp.'}, {'ForeName': 'Thomas P A', 'Initials': 'TPA', 'LastName': 'Debray', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, UMC Utrecht, Utrecht University, The Netherlands. Electronic address: T.Debray@umcutrecht.nl.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Akechi', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan. Electronic address: takechi@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Mitsuhiko', 'Initials': 'M', 'LastName': 'Yamada', 'Affiliation': 'Department of Neuropsychopharmacology, National Institute of Mental Health, National Center of Neurology and Psychiatry, Tokyo, Japan. Electronic address: mitsuhiko_yamada@ncnp.go.jp.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Aratama Kokorono Clinic, Nagoya, Japan. Electronic address: aratama8177@yahoo.co.jp.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Seo', 'Affiliation': 'Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland. Electronic address: swj8874@gmail.com.'}, {'ForeName': 'Orestis', 'Initials': 'O', 'LastName': 'Efthimiou', 'Affiliation': 'Institute of Social and Preventive Medicine, University of Bern, Switzerland. Electronic address: oremiou@gmail.com.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.141']
1433,32669306,Effects of Intensive Blood Pressure Control in Patients with and without Albuminuria:  Post Hoc  Analyses from SPRINT.,"BACKGROUND AND OBJECTIVES


It is unclear whether the presence of albuminuria modifies the effects of intensive systolic BP control on risk of eGFR decline, cardiovascular events, or mortality.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


The Systolic Blood Pressure Intervention Trial randomized nondiabetic adults ≥50 years of age at high cardiovascular risk to a systolic BP target of <120 or <140 mm Hg, measured by automated office BP. We compared the absolute risk differences and hazard ratios of ≥40% eGFR decline, the Systolic Blood Pressure Intervention Trial primary cardiovascular composite outcome, and all-cause death in those with or without baseline albuminuria (urine albumin-creatinine ratio ≥30 mg/g).
RESULTS


Over a median follow-up of 3.1 years, 69 of 1723 (4%) participants with baseline albuminuria developed ≥40% eGFR decline compared with 61 of 7162 (1%) participants without albuminuria. Incidence rates of ≥40% eGFR decline were higher in participants with albuminuria (intensive, 1.74 per 100 person-years; standard, 1.17 per 100 person-years) than in participants without albuminuria (intensive, 0.48 per 100 person-years; standard, 0.11 per 100 person-years). Although effects of intensive BP lowering on ≥40% eGFR decline varied by albuminuria on the relative scale (hazard ratio, 1.48; 95% confidence interval, 0.91 to 2.39 for albumin-creatinine ratio ≥30 mg/g; hazard ratio, 4.55; 95% confidence interval, 2.37 to 8.75 for albumin-creatinine ratio <30 mg/g;  P  value for interaction <0.001), the absolute increase in ≥40% eGFR decline did not differ by baseline albuminuria (incidence difference, 0.38 events per 100 person-years for albumin-creatinine ratio ≥30 mg/g; incidence difference, 0.58 events per 100 person-years for albumin-creatinine ratio <30 mg/g;  P  value for interaction =0.60). Albuminuria did not significantly modify the beneficial effects of intensive systolic BP lowering on cardiovascular events or mortality evaluated on relative or absolute scales.
CONCLUSIONS


Albuminuria did not modify the absolute benefits and risks of intensive systolic BP lowering.",2020,"Albuminuria did not significantly modify the beneficial effects of intensive systolic BP lowering on cardiovascular events or mortality evaluated on relative or absolute scales.
","['nondiabetic adults ≥50 years of age at high cardiovascular risk to a systolic BP target of <120 or <140 mm Hg, measured by automated office BP', 'Patients with and without Albuminuria', 'participants with albuminuria (intensive, 1.74 per 100 person-years; standard, 1.17 per 100 person-years) than in participants without albuminuria (intensive, 0.48 per 100 person-years; standard, 0.11 per 100 person-years']",['Intensive Blood Pressure Control'],"['eGFR decline, cardiovascular events, or mortality', 'Incidence rates of ≥40% eGFR decline']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4517494', 'cui_str': '1.17'}, {'cui': 'C4517461', 'cui_str': '0.48'}, {'cui': 'C4517425', 'cui_str': '0.11'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.459874,"Albuminuria did not significantly modify the beneficial effects of intensive systolic BP lowering on cardiovascular events or mortality evaluated on relative or absolute scales.
","[{'ForeName': 'Alex R', 'Initials': 'AR', 'LastName': 'Chang', 'Affiliation': 'Kidney Health Research Institute, Department of Population Health Sciences, Geisinger Health System, Danville, Pennsylvania achang@geisinger.edu.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Kramer', 'Affiliation': 'Division of Nephrology, Loyola University Medical Center, Maywood, Illinois.'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Wei', 'Affiliation': 'Division of Nephrology & Hypertension, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Boucher', 'Affiliation': 'Division of Nephrology & Hypertension, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': 'Morgan E', 'Initials': 'ME', 'LastName': 'Grams', 'Affiliation': 'Division of Nephrology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Berlowitz', 'Affiliation': 'Department of Public Health, University of Massachusetts-Lowell, Lowell, Massachusetts.'}, {'ForeName': 'Udayan', 'Initials': 'U', 'LastName': 'Bhatt', 'Affiliation': 'Division of Nephrology, The Ohio State University College of Medicine, Columbus, Ohio.'}, {'ForeName': 'Debbie L', 'Initials': 'DL', 'LastName': 'Cohen', 'Affiliation': 'Renal Division, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Drawz', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Punzi', 'Affiliation': 'Punzi Medical Center, Trinity Hypertension and Metabolic Research Institute, Carollton, Texas.'}, {'ForeName': 'Barry I', 'Initials': 'BI', 'LastName': 'Freedman', 'Affiliation': 'Section on Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Haley', 'Affiliation': 'Division of Nephrology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Amret', 'Initials': 'A', 'LastName': 'Hawfield', 'Affiliation': 'Section on Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Horwitz', 'Affiliation': 'Division of Nephrology, MetroHealth Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McLouth', 'Affiliation': 'Division of Public Health Sciences, Department of Biostatistics and Data Science, Wake Forest Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Morisky', 'Affiliation': 'Department of Community Health Sciences, University of California, Los Angeles Fielding School of Public Health, Los Angeles, California.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Papademetriou', 'Affiliation': 'Department of Cardiology, Veterans Affairs Medical Center, Georgetown University, Washington, DC.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Rocco', 'Affiliation': 'Section on Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Wall', 'Affiliation': 'Division of Nephrology, Veterans Affairs Medical Center, Memphis, Tennessee.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Weiner', 'Affiliation': 'Division of Nephrology, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Zias', 'Affiliation': 'Stony Brook University School of Medicine, Stony Brook, New York.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Beddhu', 'Affiliation': 'Division of Nephrology & Hypertension, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.12371019']
1434,32671684,"Efficacy of Tiotropium/Olodaterol Compared with Tiotropium as a First-Line Maintenance Treatment in Patients with COPD Who Are Naïve to LAMA, LABA and ICS: Pooled Analysis of Four Clinical Trials.","INTRODUCTION


The efficacy of tiotropium/olodaterol compared with tiotropium in patients with chronic obstructive pulmonary disease (COPD) has been demonstrated in a large clinical programme. Currently, randomised controlled trial (RCT) data on dual bronchodilation as first-line maintenance therapy are limited. In this post hoc analysis of pooled data from four RCTs, we compared the efficacy of tiotropium/olodaterol versus tiotropium as maintenance therapy in patients with COPD who were not receiving maintenance treatment with long-acting muscarinic antagonists (LAMAs), long-acting β 2 -agonists (LABAs) or inhaled corticosteroids (ICS) (""maintenance naïve"") at study entry.
METHODS


TONADO ®  1/2 (52 weeks) and OTEMTO ®  1/2 (12 weeks) were phase III RCTs in patients with COPD. TONADO 1/2 and OTEMTO 1/2 enrolled patients with post-bronchodilator forced expiratory volume in 1 s (FEV 1 ) < 80% predicted (lower limit FEV 1  ≥ 30% in OTEMTO 1/2 only). We examined the effect of tiotropium/olodaterol 5/5 µg versus tiotropium 5 µg on trough FEV 1  response, St. George's Respiratory Questionnaire (SGRQ) total score and Transition Dyspnoea Index (TDI) focal score at 12 weeks in four pooled studies.
RESULTS


The pooled analysis included 1078 maintenance-naïve patients. There were significant improvements with tiotropium/olodaterol versus tiotropium in trough FEV 1  [0.056 L; 95% confidence interval (CI) 0.033, 0.079; P < 0.0001], SGRQ score (- 1.780; 95% CI - 3.126 to - 0.434; P = 0.0096) and TDI score (0.409; 95% CI 0.077, 0.741; P = 0.0158) at week 12. For patients receiving tiotropium/olodaterol, the odds of achieving a minimal clinically important difference from baseline in any of the analysed outcomes (FEV 1  ≥ 0.1 L, SGRQ ≥ 4.0 points or TDI ≥ 1.0 point) were higher versus tiotropium.
CONCLUSIONS


In patients who were maintenance naïve at baseline, treatment initiation with tiotropium/olodaterol resulted in greater improvements in lung function, health status and dyspnoea severity compared with tiotropium alone, without compromising patient safety. These results support the use of dual bronchodilation with tiotropium/olodaterol as first-line maintenance treatment in patients with COPD.
TRIAL REGISTRATION


ClinicalTrials.gov: TONADO ®  1 and 2 (NCT01431274 and NCT01431287, registered 8 September 2011) and OTEMTO ®  1 and 2 (NCT01964352 and NCT02006732, registered 14 October 2013).",2020,"There were significant improvements with tiotropium/olodaterol versus tiotropium in trough FEV 1  [0.056 L; 95% confidence interval (CI) 0.033, 0.079; P < 0.0001], SGRQ score (- 1.780; 95% CI - 3.126 to - 0.434; P = 0.0096) and TDI score (0.409; 95% CI 0.077, 0.741; P = 0.0158) at week 12.","['1078 maintenance-naïve patients', 'patients with COPD', '1/2 enrolled patients with post-bronchodilator forced expiratory volume in 1\xa0s (FEV 1 )\u2009<\u200980% predicted (lower limit FEV 1 \u2009≥\u200930% in OTEMTO\xa01/2 only', 'patients with COPD who were not receiving maintenance treatment with long-acting muscarinic antagonists (LAMAs), long-acting β 2 -agonists (LABAs) or inhaled corticosteroids (ICS) (""maintenance naïve"") at study entry', 'patients with chronic obstructive pulmonary disease (COPD', 'Patients with COPD']","['tiotropium/olodaterol\xa05/5\xa0µg versus tiotropium', 'ICS', 'Tiotropium/Olodaterol', 'tiotropium/olodaterol', 'tiotropium/olodaterol versus tiotropium', 'Tiotropium', 'tiotropium']","['lung function, health status and dyspnoea severity', 'SGRQ score', 'TDI score', ""trough FEV 1  response, St. George's Respiratory Questionnaire (SGRQ) total score and Transition Dyspnoea Index (TDI) focal score""]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205976', 'cui_str': 'Toluene di-isocyanate-containing product'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205234', 'cui_str': 'Focal'}]",,0.220967,"There were significant improvements with tiotropium/olodaterol versus tiotropium in trough FEV 1  [0.056 L; 95% confidence interval (CI) 0.033, 0.079; P < 0.0001], SGRQ score (- 1.780; 95% CI - 3.126 to - 0.434; P = 0.0096) and TDI score (0.409; 95% CI 0.077, 0.741; P = 0.0158) at week 12.","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Buhl', 'Affiliation': 'Pulmonary Department, Johannes Gutenberg Universitat Mainz, Mainz, Germany. Roland.Buhl@unimedizin-mainz.de.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'de la Hoz', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Wenqiong', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.'}]",Advances in therapy,['10.1007/s12325-020-01411-0']
1435,32668743,Assessment of Mortality and Factors Affecting Outcome of Use of Paclitaxel-Coated Stents and Bare Metal Stents in Femoropopliteal PAD.,"The use of drug-coated devices in intravascular therapy is aimed at preventing neointimal hyperplasia caused by excessive proliferation of vascular smooth muscle and thereby restenosis. Although its use seemed initially promising, a recent publication has shown an increased risk of mortality with paclitaxel-coated devices, and there is an urgent need to reaffirm assessments of drug-eluting stents (DES).
OBJECTIVE


The aim of the study was to compare mortality and effectiveness of paclitaxel-coated stents and bare-metal stents (BMS) in the treatment of peripheral arterial disease (PAD) with long-term follow-up.
MATERIALS AND METHODS


In a single center randomized study, 256 patients with PAD were treated intravascularly with stent implantation. Patients were randomized into two groups: the first (n = 126) were treated with DES, and the second (n = 130) were treated with BMS. The study included evaluation after the procedure, after about 6 months and 36 months. Co-morbidities, with risks for atherosclerosis, were analyzed in all patients. Patients were evaluated for clinical outcome, restenosis frequency, and safety (complications and total mortality).
RESULTS


Clinical benefit at the end of the investigation was statistically significantly better in the DES group compared with the BMS group: 85.7% versus 66.2% ( p  = 0.0003), respectively. Restenosis occurred significantly less frequently in patients with DES: 16.0% versus BMS: 35.0%,  p  = 0.012. There was no significant effect of comorbidities on the frequency of restenoses. There were no differences in all-cause mortality over the three years with paclitaxel and no-paclitaxel stents cohorts (8.7% versus 7.1%; long-rank  p  = 0.575). No association was found with mortality and treatment with DES or BMS.
CONCLUSIONS


The use of paclitaxel-coated stents gave good clinical benefit and caused a significantly lower frequency of restenosis compared to bare-metal stents. The use of paclitaxel-coated stents did not increase mortality.",2020,"Restenosis occurred significantly less frequently in patients with DES: 16.0% versus BMS: 35.0%,  p  = 0.012.","['Femoropopliteal PAD', '256 patients with PAD', 'peripheral arterial disease (PAD']","['BMS', 'stent implantation', 'Paclitaxel-Coated Stents and Bare Metal Stents', 'paclitaxel-coated stents and bare-metal stents (BMS', 'paclitaxel-coated stents']","['frequency of restenosis', 'clinical outcome, restenosis frequency, and safety (complications and total mortality', 'mortality and effectiveness', 'frequency of restenoses', 'mortality', 'Restenosis', 'cause mortality']","[{'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2825200', 'cui_str': 'Bare metal stent'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0453946', 'cui_str': 'Coat'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",256.0,0.0305396,"Restenosis occurred significantly less frequently in patients with DES: 16.0% versus BMS: 35.0%,  p  = 0.012.","[{'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Falkowski', 'Affiliation': 'Department of Interventional Radiology, Pomeranian Medical University, 70-111 Szczecin, Poland.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Bogacki', 'Affiliation': 'Department of Interventional Radiology, Pomeranian Medical University, 70-111 Szczecin, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Szemitko', 'Affiliation': 'Department of Interventional Radiology, Pomeranian Medical University, 70-111 Szczecin, Poland.'}]",Journal of clinical medicine,['10.3390/jcm9072221']
1436,32653055,"Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trial.","BACKGROUND


Vitiligo is a chronic autoimmune disease resulting in skin depigmentation and reduced quality of life. There is no approved treatment for vitiligo repigmentation and current off-label therapies have limited efficacy, emphasising the need for improved treatment options. We investigated the therapeutic potential of ruxolitinib cream in patients with vitiligo and report the efficacy and safety results up to 52 weeks of double-blind treatment.
METHODS


We did a multicentre, randomised, double-blind, phase 2 study for adult patients with vitiligo in 26 US hospitals and medical centres in 18 states. Patients with depigmentation of 0·5% or more of their facial body surface area (BSA) and 3% or more of their non-facial BSA were randomly assigned (1:1:1:1:1) by use of an interactive response technology system to receive ruxolitinib cream (1·5% twice daily, 1·5% once daily, 0·5% once daily, or 0·15% once daily) or vehicle (control group) twice daily on lesions constituting 20% or less of their total BSA for 24 weeks. Patients in the control group in addition to patients in the 0·15% once daily group who did not show a 25% or higher improvement from baseline in facial Vitiligo Area Scoring Index (F-VASI) at week 24 were re-randomised to one of three higher ruxolitinib cream doses (0·5% once daily, 1·5% once daily, 1·5% twice daily). Patients in the 0·5% once daily, 1·5% once daily, or 1·5% twice daily groups remained at their original dose up to week 52. Patients, investigators, and the study sponsor (except members of the interim analysis and primary endpoint analysis data monitoring teams) remained masked to treatment assignment throughout the study. The primary endpoint was the proportion of patients achieving a 50% or higher improvement from baseline in F-VASI (F-VASI50) at week 24, assessed in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT03099304.
FINDINGS


Between June 7, 2017, and March 21, 2018, 205 patients were screened for eligibility, 48 were excluded and 157 patients (mean age, 48·3 years [SD 12·9]; 73 [46%] male and 84 [54%] female) were randomly assigned to either an intervention group or the control group. 32 (20%) of 157 were assigned to the control group, 31 (20%) to the 0·15% once daily group, 31 (20%) to the 0·5% once daily group, 30 (19%) to the 1·5% once daily group, and 33 (21%) to the 1·5% twice daily group. F-VASI50 at week 24 was reached by significantly more patients given ruxolitinib cream at 1·5% twice daily (15 [45%] of 33) and 1·5% once daily (15 [50%] of 30) than were treated with vehicle (one [3%] of 32). Four patients had serious treatment-emergent adverse events (one patient in the 1·5% twice daily group developed subdural haematoma; one patient in the 1·5% once daily group had a seizure; one patient in the 0·5% once daily group had coronary artery occlusion; and one patient in the 0·5% once daily group had oesophageal achalasia), all of which were unrelated to study treatment. Application site pruritus was the most common treatment-related adverse event among patients given ruxolitinib cream (one [3%] of 33 in the 1·5% twice daily group; three [10%] of 30 in the 1·5% once daily group; three [10%] of 31 in the 0·5% once daily group; and six [19%] of 31 in the 0·15% once daily group)with three [9%] of 32 patients showing application site pruritis in the control group. Acne was noted as a treatment-related adverse event in 13 (10%) of 125 patients who received ruxolitinib cream and one (3%) of 32 patients who received vehicle cream. All treatment-related adverse events were mild or moderate in severity and similar across treatment groups.
INTERPRETATION


Treatment with ruxolitinib cream was associated with substantial repigmentation of vitiligo lesions up to 52 weeks of treatment, and all doses were well tolerated. These data suggest that ruxolitinib cream might be an effective treatment option for patients with vitiligo.
FUNDING


Incyte.",2020,Application site pruritus was the most common treatment-related adverse event among patients given ruxolitinib cream (one [3%] of 33 in the 1·5% twice daily group; three [10%] of 30 in the 1·5% once daily group; three [10%] of 31 in the 0·5% once daily group; and six [19%] of 31 in the 0·15% once daily group)with three [9%] of 32 patients showing application site pruritis in the control group.,"['vitiligo', 'patients with vitiligo', 'adult patients with vitiligo in 26 US hospitals and medical centres in 18 states', '205 patients were screened for eligibility, 48 were excluded and 157 patients (mean age, 48·3 years [SD 12·9]; 73 [46%] male and 84 [54%] female', 'Between June 7, 2017, and March 21, 2018', 'Patients with depigmentation of 0·5% or more of their facial body surface area (BSA) and 3% or more of their non-facial BSA']","['interactive response technology system to receive ruxolitinib cream (1·5% twice daily, 1·5% once daily, 0·5% once daily, or 0·15% once daily) or vehicle (control group) twice daily on lesions constituting 20% or less of their total BSA', 'ruxolitinib cream', 'Ruxolitinib cream', 'vehicle cream']","['substantial repigmentation of vitiligo lesions', 'tolerated', 'F-VASI50', 'oesophageal achalasia', 'serious treatment-emergent adverse events', 'facial Vitiligo Area Scoring Index', 'subdural haematoma', 'proportion of patients achieving a 50% or higher improvement from baseline in F-VASI (F-VASI50', 'coronary artery occlusion']","[{'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0162835', 'cui_str': 'Hypopigmentation'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C2931926', 'cui_str': 'ruxolitinib'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0229978', 'cui_str': '90 percent of body surface or more'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0014848', 'cui_str': 'Achalasia of esophagus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018946', 'cui_str': 'Subdural hematoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0151814', 'cui_str': 'Coronary occlusion'}]",205.0,0.162939,Application site pruritus was the most common treatment-related adverse event among patients given ruxolitinib cream (one [3%] of 33 in the 1·5% twice daily group; three [10%] of 30 in the 1·5% once daily group; three [10%] of 31 in the 0·5% once daily group; and six [19%] of 31 in the 0·15% once daily group)with three [9%] of 32 patients showing application site pruritis in the control group.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rosmarin', 'Affiliation': 'Tufts Medical Center, Boston, MA, USA. Electronic address: drosmarin@tuftsmedicalcenter.org.'}, {'ForeName': 'Amit G', 'Initials': 'AG', 'LastName': 'Pandya', 'Affiliation': 'Palo Alto Foundation Medical Group, Mountain View, CA, USA; University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Pearl', 'Initials': 'P', 'LastName': 'Grimes', 'Affiliation': 'The Vitiligo and Pigmentation Institute of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Iltefat', 'Initials': 'I', 'LastName': 'Hamzavi', 'Affiliation': 'Henry Ford Medical Center, Detroit, MI, USA.'}, {'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Butler', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Kuo', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Sun', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Ji', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Howell', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Harris', 'Affiliation': 'University of Massachusetts Medical School, Worcester, MA, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)30609-7']
1437,32653721,Leveraging immersive technology to expand access to opioid overdose reversal training in community settings: Results from a randomized controlled equivalence trial.,"BACKGROUND


Immersive video (e.g. virtual reality) poses a promising and engaging alternative to standard in-person trainings and can potentially increase access to evidence-based opioid overdose prevention programs (OOPPs). Therefore, the objective of this equivalence study was to test whether the immersive video OOPP was equivalent to a standard in-person OOPP for changes in opioid overdose knowledge and attitudes.
METHODS


A team of nurses and communication researchers developed a 9-minute immersive video OOPP. To test whether this immersive video OOPP (treatment) demonstrated equivalent gains in opioid overdose response knowledge and attitudes as in-person OOPPs (standard of care control), researchers deployed a two-day field experiment in Philadelphia, Pennsylvania, USA. In this equivalence trial, 9 libraries were randomly assigned to offer treatment or control OOPP to community members attending naloxone giveaway events. In this equivalence design, a difference between treatment and control groups pre- to post-training scores within -1.0 to 1.0 supports equivalence between the trainings.
RESULTS


Results demonstrate participants (N = 94) exposed to the immersive video OOPP had equivalent improvements on posttest knowledge (β=-0.18, p = .61) and more favorable attitudes about responding to an opioid overdose (β=0.26, p = .02) than those exposed to the standard OOPP. However, these minor differences in knowledge and attitudes were within the equivalence interval indicating that the immersive video OOPP remained equivalently effective for community members.
CONCLUSIONS


Community partnerships, like those between public health departments and libraries, can provide opportunities for deploying novel immersive video OOPP that, alongside standard offerings, can strengthen community response to the opioid crisis.",2020,"RESULTS


Results demonstrate participants (N = 94) exposed to the immersive video OOPP had equivalent improvements on posttest knowledge (β=-0.18, p = .61) and more favorable attitudes about responding to an opioid overdose (β=0.26, p = .02) than those exposed to the standard OOPP.",['community settings'],"['immersive video OOPP (treatment', 'immersive video OOPP', 'control OOPP']","['posttest knowledge', 'favorable attitudes about responding to an opioid overdose']","[{'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}]",9.0,0.046718,"RESULTS


Results demonstrate participants (N = 94) exposed to the immersive video OOPP had equivalent improvements on posttest knowledge (β=-0.18, p = .61) and more favorable attitudes about responding to an opioid overdose (β=0.26, p = .02) than those exposed to the standard OOPP.","[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Herbert', 'Affiliation': 'Woods Institute for the Environment, Stanford University, 473 Via Ortega, Stanford, CA, USA.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Axson', 'Affiliation': 'School of Nursing, University of Pennsylvania, 418 Curie Boulevard, Philadelphia, PA, USA.'}, {'ForeName': 'Leeann', 'Initials': 'L', 'LastName': 'Siegel', 'Affiliation': 'Annenberg School for Communication, University of Pennsylvania, 620 Walnut Street, Philadelphia, PA, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Cassidy', 'Affiliation': 'Annenberg School for Communication, University of Pennsylvania, 620 Walnut Street, Philadelphia, PA, USA.'}, {'ForeName': 'Ann Marie', 'Initials': 'AM', 'LastName': 'Hoyt-Brennan', 'Affiliation': 'School of Nursing, University of Pennsylvania, 418 Curie Boulevard, Philadelphia, PA, USA.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Whitney', 'Affiliation': 'School of Nursing, University of Pennsylvania, 418 Curie Boulevard, Philadelphia, PA, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Herens', 'Affiliation': 'Division of Substance Use Prevention and Harm Reduction, Philadelphia Department of Public Health, 1101 Market Street, 13th Floor, Suite 1320, Philadelphia PA, USA.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Giordano', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing, Emory University, 1520 Clifton Road, Atlanta, GA, USA. Electronic address: ngiorda@emory.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108160']
1438,32653726,High rate of antimicrobial resistance and multiple mutations in the dihydrofolate reductase gene among Streptococcus pneumoniae isolated from HIV-infected adults in a community setting in Tanzania.,"OBJECTIVES


The aim of this study was to characterize molecular mechanisms of resistance to trimethoprim and other antibiotics in Streptococcus pneumoniae isolates from HIV-infected adults in Dar es Salaam, Tanzania.
METHODS


A total of 1877 nasopharyngeal swabs were collected and screened for pneumococcal colonization from 537 newly diagnosed individuals with HIV at four clinic visits during a 1-year follow-up from 2017-2018 as part of the randomized clinical trial CoTrimResist (ClinicalTrials.gov ID: NCT03087890).
RESULTS


A total of 76 pneumococcal isolates were obtained. Of the 70 isolates that could be serotyped, 42 (60.0%) were vaccine serotypes included in pneumococcal conjugate vaccine 23 (PCV23). The majority of isolates (73.7%; 56/76) were non-susceptible to penicillin (MICs of 0.06-2μg/mL). Isolates were frequently resistant to co-trimoxazole (trimethoprim/sulfamethoxazole) (71.1%) but less so to azithromycin (22.4%), erythromycin (21.1%), chloramphenicol (18.4%), tetracycline (14.5%), clindamycin (10.5%) and levofloxacin (0%). Moreover, 26.3% were multidrug-resistant (resistant to ≥3 antibiotic classes). Vaccine-type pneumococci were resistant to more classes of antibiotics, were more frequently resistant to erythromycin, azithromycin, clindamycin and tetracycline, and had higher MICs to penicillin (median, 0.19μg/mL; range, 0.002-1.5μg/mL) compared with non-vaccine serotypes (median, 0.125μg/mL; range, 0.012-0.25μg/mL) (P=0.003). Co-trimoxazole-resistant isolates carried from 1 to 11 different mutations in the dihydrofolate reductase (DHFR) gene, most commonly Ile100Leu (100%), Glu20Asp (91.8%), Glu94Asp (61.2%), Leu135Phe (57.1%), His26Tyr (53.1%), Asp92Ala (53.1%) and His120Gln (53.1%).
CONCLUSION


Streptococcus pneumoniae isolated from HIV-diagnosed patients were frequently non-susceptible to penicillin and co-trimoxazole. Most isolates carried multiple mutations in DHFR.",2020,"Vaccine-type pneumococci were resistant to more classes of antibiotics; more frequently resistant to erythromycin, azithromycin, clindamycin and tetracycline, and had higher MIC-values towards penicillin (Median 0.19; range 0.002-1.5) versus non-vaccine types (Median 0.125; range 0.012-0.25), p = 0.003.","['1877 nasopharyngeal swabs were collected and screened for pneumococcal colonization from 537 newly diagnosed individuals with HIV at four clinic visits during a one-year follow-up from 2017 -2018', 'Twenty-six percent were multi-drug resistant (resistant to ≥3 antibiotic classes', 'Streptococcus pneumoniae isolates from HIV-infected adults in Dar es Salaam, Tanzania', 'Streptococcus pneumoniae isolated from HIV-infected adults in a community setting in Tanzania']","['clindamycin', 'tetracycline', 'erythromycin, azithromycin, clindamycin and tetracycline', 'levofloxacin', 'chloramphenicol', 'erythromycin', 'azithromycin']",['penicillin non-susceptible minimum inhibitory concentration (MIC'],"[{'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022595', 'cui_str': 'Darier disease'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0008947', 'cui_str': 'Clindamycin'}, {'cui': 'C0039644', 'cui_str': 'Tetracycline'}, {'cui': 'C0014806', 'cui_str': 'Erythromycin'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0008168', 'cui_str': 'Chloramphenicol'}]","[{'cui': 'C0030842', 'cui_str': 'Penicillin'}, {'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0427978', 'cui_str': 'MIC'}]",1877.0,0.4074,"Vaccine-type pneumococci were resistant to more classes of antibiotics; more frequently resistant to erythromycin, azithromycin, clindamycin and tetracycline, and had higher MIC-values towards penicillin (Median 0.19; range 0.002-1.5) versus non-vaccine types (Median 0.125; range 0.012-0.25), p = 0.003.","[{'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Manyahi', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway; National Centre for Tropical Infectious Diseases, Department of Medicine, Haukeland University Hospital, Bergen, Norway; Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences (MUHAS), Dar es Salaam, Tanzania. Electronic address: manyahijoel@yahoo.com.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Moyo', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway; Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences (MUHAS), Dar es Salaam, Tanzania.'}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Aboud', 'Affiliation': 'Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences (MUHAS), Dar es Salaam, Tanzania.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Langeland', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway; National Centre for Tropical Infectious Diseases, Department of Medicine, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Blomberg', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway; National Centre for Tropical Infectious Diseases, Department of Medicine, Haukeland University Hospital, Bergen, Norway.'}]",Journal of global antimicrobial resistance,['10.1016/j.jgar.2020.06.026']
1439,32654400,Safety and efficacy of single pass vs multipass emission with 755 alexandrite laser for all-skin-type hair removal: A pilot study.,"Lasers are considered the most efficient methods for hair reduction. The goal of these devices is to provide long-term effects without adverse reactions. This is a randomized split-body controlled study on body hair removal and pseudofolliculitis (PFC) treatment, comparing the standard single pass (SP) emission with the multipass emission (Moveo handpiece) with 755 alexandrite laser. Patients with Fitzpatrick skin types I to VI underwent laser hair removal, by treating one side of the body using the standard SP and the other side with Moveo. Treated areas included face, arms, legs, trunk, axillae and groins. Each patient underwent a minimum of three to a maximum of eight treatments, every 6 weeks, with a 6-month follow-up. Hair reduction, side effects, PFC severity score and patient satisfaction were recorded for all patients. Totally, 108 patients were enrolled, of whom 96 were female. The overall hair reduction rate (% ± SD), independent of skin type, was estimated as 87 ± 5.5 for standard SP and 78.5 ± 7.6 for Moveo. No significant statistically differences were found between the two groups. Side effects included pain, which was higher after standard SP (4.2 ± 0.8) than after Moveo treatment (1.5 ± 0.5). A statistical significant difference between the two devices was found (P = .0002). PFC score improved in almost all the patients. Patients declared to be satisfied with both the treatments, reporting a preference for Moveo (84% vs 16%) (P = .01). Standard SP and Moveo 755 alexandrite laser seems to be safe and effective treatments for hair removal in all Fitzpatrick skin types and for PFC. Moveo has a higher security profile with fewer side effects.",2020,"Side effects included pain, which was higher after standard SP (4.2 ± 0.8) than after Moveo treatment (1.5 ± 0.5).","['108 patients were enrolled, of whom 96 were female', 'Patients with Fitzpatrick skin types I-VI underwent laser hair removal, by treating one side of the body using the standard SP and the other side with Moveo']","['Single Pass Versus MultiPass emission with 755 alexandrite Laser', 'standard Single Pass (SP) emission with the MultiPass emission (Moveo handpiece) with 755 alexandrite laser', 'body hair removal and pseudofolliculitis (PFC']","['Hair reduction, side effects, PFC severity score and patient satisfaction', 'overall hair reduction rate', 'PFC score', 'Safety and Efficacy']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0587210', 'cui_str': 'Laser removal of hair'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0445262', 'cui_str': 'Single pass'}]","[{'cui': 'C0445262', 'cui_str': 'Single pass'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C4517872', 'cui_str': '755'}, {'cui': 'C0392245', 'cui_str': 'Alexandrite laser device'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0181115', 'cui_str': 'Handpiece'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0018504', 'cui_str': 'Epilation'}, {'cui': 'C0406191', 'cui_str': 'Pseudofolliculitis'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0406191', 'cui_str': 'Pseudofolliculitis'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",108.0,0.0449255,"Side effects included pain, which was higher after standard SP (4.2 ± 0.8) than after Moveo treatment (1.5 ± 0.5).","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bonan', 'Affiliation': 'Laser Cutaneous Cosmetic & Plastic Surgery Unit, Villa Donatello Clinic, Florence, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Troiano', 'Affiliation': 'Laser Cutaneous Cosmetic & Plastic Surgery Unit, Villa Donatello Clinic, Florence, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Verdelli', 'Affiliation': 'Laser Cutaneous Cosmetic & Plastic Surgery Unit, Villa Donatello Clinic, Florence, Italy.'}]",Dermatologic therapy,['10.1111/dth.14001']
1440,32654554,Carbidopa for Afferent Baroreflex Failure in Familial Dysautonomia: A Double-Blind Randomized Crossover Clinical Trial.,"Afferent lesions of the arterial baroreflex occur in familial dysautonomia. This leads to excessive blood pressure variability with falls and frequent surges that damage the organs. These hypertensive surges are the result of excess peripheral catecholamine release and have no adequate treatment. Carbidopa is a selective DOPA-decarboxylase inhibitor that suppresses catecholamines production outside the brain. To learn whether carbidopa can inhibit catecholamine-induced hypertensive surges in patients with severe afferent baroreflex failure, we conducted a double-blind randomized crossover trial in which patients with familial dysautonomia received high dose carbidopa (600 mg/day), low-dose carbidopa (300 mg/day), or matching placebo in 3 4-week treatment periods. Among the 22 patients enrolled (13 females/8 males), the median age was 26 (range, 12-59 years). At enrollment, patients had hypertensive peaks to 164/116 (range, 144/92 to 213/150 mm Hg). Twenty-four hour urinary norepinephrine excretion, a marker of peripheral catecholamine release, was significantly suppressed on both high dose and low dose carbidopa, compared with placebo ( P =0.0075). The 2 co-primary end points of the trial were met. The SD of systolic BP variability was reduced at both carbidopa doses (low dose: 17±4; high dose: 18±5 mm Hg) compared with placebo (23±7 mm Hg;  P =0.0013), and there was a significant reduction in the systolic BP peaks on active treatment ( P =0.0015). High- and low-dose carbidopa were similarly effective and well tolerated. This study provides class Ib evidence that carbidopa can reduce blood pressure variability in patients with congenital afferent baroreflex failure. Similar beneficial effects are observed in patients with acquired baroreflex lesions.",2020,"Twenty-four hour urinary norepinephrine excretion, a marker of peripheral catecholamine release, was significantly suppressed on both high dose and low dose carbidopa, compared with placebo ( P =0.0075).","['patients had hypertensive peaks to 164/116 (range, 144/92 to 213/150 mm Hg', 'patients with congenital afferent baroreflex failure', 'Familial Dysautonomia', 'familial dysautonomia', '22 patients enrolled (13 females/8 males), the median age was 26 (range, 12-59 years', 'patients with familial dysautonomia', 'patients with severe afferent baroreflex failure', 'patients with acquired baroreflex lesions']","['placebo', 'carbidopa', 'High- and low-dose carbidopa', 'Carbidopa']","['SD of systolic BP variability', 'effective and well tolerated', 'systolic BP peaks', 'blood pressure variability']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0013364', 'cui_str': 'Familial dysautonomia'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",22.0,0.236703,"Twenty-four hour urinary norepinephrine excretion, a marker of peripheral catecholamine release, was significantly suppressed on both high dose and low dose carbidopa, compared with placebo ( P =0.0075).","[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Norcliffe-Kaufmann', 'Affiliation': 'From the Department of Neurology, NYU Dysautonomia Center, New York University School of Medicine.'}, {'ForeName': 'Jose-Alberto', 'Initials': 'JA', 'LastName': 'Palma', 'Affiliation': 'From the Department of Neurology, NYU Dysautonomia Center, New York University School of Medicine.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Martinez', 'Affiliation': 'From the Department of Neurology, NYU Dysautonomia Center, New York University School of Medicine.'}, {'ForeName': 'Horacio', 'Initials': 'H', 'LastName': 'Kaufmann', 'Affiliation': 'From the Department of Neurology, NYU Dysautonomia Center, New York University School of Medicine.'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.15267']
1441,32656692,Pilot Randomized Controlled Trial of an Interconception Intervention Provided by Public Health Nurses.,"OBJECTIVES


Preconception health impacts perinatal outcomes, but the difficulty in engaging reproductive-aged individuals in health promotion activities is a barrier to effective implementation of preconception interventions. Since most women have more than one pregnancy and many risk factors repeat across pregnancies, the time between pregnancies-the interconception period-may be an opportune time to improve health. Our objective was to examine the feasibility and acceptability of an interconception intervention delivered by public health nurses.
METHODS


We conducted a pilot randomized controlled trial in three small urban and rural public health units in Ontario, Canada, in 2017-2018 among women who were ≥ 18 years of age and between 2 and 12 months postpartum after a first birth. Women randomly allocated to the intervention group received a preconception risk assessment, tailored health education, and referral for clinical follow-up as needed, while those in the control group received standard care. Primary outcomes were intervention feasibility, adherence, and acceptability.
RESULTS


Of 66 eligible women, 61% agreed to participate and were randomized to the intervention (n = 16) or control (n = 24) groups. The follow-up rate was 78% at 1 month and 71% at 3 months. Most women (83%) were satisfied with the intervention, including the number and length of sessions and content of recommendations.
CONCLUSIONS FOR PRACTICE


Results demonstrate the potential feasibility and acceptability of an interconception intervention delivered in a public health setting. The short- and long-term impacts of the intervention on knowledge, behavior, and health should be tested in a larger sample.",2020,"Most women (83%) were satisfied with the intervention, including the number and length of sessions and content of recommendations.
","['engaging reproductive-aged individuals in health promotion activities', '66 eligible women', 'Public Health Nurses', '18\xa0years of age and between 2 and 12\xa0months postpartum after a first birth', 'three small urban and rural public health units in Ontario, Canada, in 2017-2018 among women who were\u2009≥']","['interconception intervention', 'preconception risk assessment, tailored health education, and referral for clinical follow-up as needed, while those in the control group received standard care', 'Interconception Intervention']","['feasibility and acceptability', 'knowledge, behavior, and health', 'intervention feasibility, adherence, and acceptability', 'number and length of sessions and content of recommendations']","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034022', 'cui_str': 'Public health nurse'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0016145', 'cui_str': 'First Birth'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",66.0,0.0888779,"Most women (83%) were satisfied with the intervention, including the number and length of sessions and content of recommendations.
","[{'ForeName': 'Saranyah', 'Initials': 'S', 'LastName': 'Ravindran', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Shaira', 'Initials': 'S', 'LastName': 'Yoganathan', 'Affiliation': 'Interdisciplinary Centre for Health & Society, University of Toronto Scarborough, Toronto, ON, Canada.'}, {'ForeName': 'Zoe F', 'Initials': 'ZF', 'LastName': 'Cairncross', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Cindy-Lee', 'Initials': 'CL', 'LastName': 'Dennis', 'Affiliation': ""Women's College Research Institute, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Enders', 'Affiliation': 'Ontario Public Health Association, Toronto, ON, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Graves', 'Affiliation': 'Department of Family and Community Medicine, Western Michigan University Homer Stryker M.D. School of Medicine, Kalamazoo, MI, USA.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'Mill', 'Affiliation': 'Ontario Public Health Association, Toronto, ON, Canada.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'Telner', 'Affiliation': 'Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Hilary K', 'Initials': 'HK', 'LastName': 'Brown', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada. hk.brown@utoronto.ca.'}]",Maternal and child health journal,['10.1007/s10995-020-02980-w']
1442,32658765,Assessment of stress markers in restrained individuals following physical stress with and without sham CED activation.,"INTRODUCTION


Law enforcement and pre-hospital care personnel often confront individuals who must be physically restrained. Many are under the influence of illicit substances, and law enforcement officers may need to use a controlled electrical device (CED) to gain control of the individual and they are often placed into the prone maximum restraint (PMR) position. These techniques have previously been evaluated for their physiologic effects. The purpose of this study was to investigate the psychological effects of anticipating and experiencing a sham CED activation in healthy human subjects who were exercised and restrained compared with no sham activation by assessing the differences in a panel of several known biomarkers of stress.
METHODS


We performed a randomized, crossover controlled human subject trial to study the stress associated with exercise, physical exhaustion, and restraint with and without an added psychological stress simulating the field use of a CED. Twenty five total subjects; each subject performed two different trials each consisting of a brief period of intense exercise on a treadmill to exhaustion followed by placement in the PMR with and without induced psychological stress. Blood samples were collected for analysis pre and post exercise, as well as 10 min after completion of the exercise. A panel of hormones and stress markers were measured.
RESULTS


We found no significant differences in any of the stress biomarkers measured between the two study groups. A trend towards higher levels of copeptin was measured in the sham CED activation arm.
CONCLUSION


During a brief period of intense exercise followed by the psychological stress of anticipated CED application, there did not appear to be statistically significant changes in the stress panel of biomarkers measured, only a trend towards significance for higher copeptin levels in the patients exposed to the psychological stress.",2020,We found no significant differences in any of the stress biomarkers measured between the two study groups.,"['healthy human subjects', 'Twenty five total subjects']",['intense exercise on a treadmill to exhaustion followed by placement in the PMR with and without induced psychological stress'],"['stress biomarkers', 'levels of copeptin']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0056279', 'cui_str': 'copeptins'}]",25.0,0.0515782,We found no significant differences in any of the stress biomarkers measured between the two study groups.,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sloane', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA. Electronic address: csloane@ucsd.edu.'}, {'ForeName': 'Deborah C', 'Initials': 'DC', 'LastName': 'Mash', 'Affiliation': 'Department of Neurology, Molecular and Cellular Pharmacology, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Theodore C', 'Initials': 'TC', 'LastName': 'Chan', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Kolkhorst', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University San Diego, CA, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Neuman', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Castillo', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lasoff', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Wardi', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA; Division of Pulmonary, Critical Care, and Sleep Medicine, University of California, San Diego, San Diego, CA, USA.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Department of Neurology, Molecular and Cellular Pharmacology, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Vilke', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA.'}]",Journal of forensic and legal medicine,['10.1016/j.jflm.2020.101982']
1443,32659482,Transcranial random noise stimulation is more effective than transcranial direct current stimulation for enhancing working memory in healthy individuals: Behavioural and electrophysiological evidence.,"BACKGROUND


Transcranial direct current stimulation (tDCS) has been shown to improve working memory (WM) performance in healthy individuals, however effects tend to be modest and variable. Transcranial random noise stimulation (tRNS) can be delivered with a direct-current offset (DC-offset) to induce equal or even greater effects on cortical excitability than tDCS. To-date, no research has directly compared the effects of these techniques on WM performance or underlying neurophysiological activity.
OBJECTIVE


To compare the effects of anodal tDCS, tRNS + DC-offset, or sham stimulation over the left dorsolateral prefrontal cortex (DLPFC) on WM performance and task-related EEG oscillatory activity in healthy adults.
METHODS


Using a between-subjects design, 49 participants were allocated to receive either anodal tDCS (N = 16), high-frequency tRNS + DC-offset (N = 16), or sham stimulation (N = 17) to the left DLPFC. Changes in WM performance were assessed using the Sternberg WM task completed before and 5- and 25-min post-stimulation. Event-related synchronisation/desynchronisation (ERS/ERD) of oscillatory activity was analysed from EEG recorded during WM encoding and maintenance.
RESULTS


tRNS induced more pronounced and consistent enhancements in WM accuracy when compared to both tDCS and sham stimulation. Improvements in WM performance following tRNS were accompanied by increased theta ERS and diminished gamma ERD during WM encoding, which were significantly greater than those observed following anodal tDCS or sham stimulation.
CONCLUSIONS


These findings demonstrate the potential of tRNS + DC-offset to modulate cognitive and electrophysiological measures of WM and raise the possibility that tRNS + DC-offset may be more effective and reliable than tDCS for enhancing WM performance in healthy individuals.",2020,"Improvements in WM performance following tRNS were accompanied by increased theta ERS and diminished gamma ERD during WM encoding, which were significantly greater than those observed following anodal tDCS or sham stimulation.
","['49 participants', 'healthy individuals', 'healthy adults', 'Healthy Individuals']","['Transcranial direct current stimulation (tDCS', 'high-frequency tRNS + DC-offset (N = 16), or sham stimulation (N = 17) to the left DLPFC', 'anodal tDCS', 'tDCS', 'Transcranial random noise stimulation (tRNS', 'Transcranial Direct Current Stimulation', 'Transcranial Random Noise Stimulation', 'anodal tDCS, tRNS + DC-offset, or sham stimulation']","['WM performance and task-related EEG oscillatory activity', 'Event-related synchronisation/desynchronisation (ERS/ERD) of oscillatory activity', 'Changes in WM performance', 'working memory (WM) performance', 'WM accuracy', 'theta ERS and diminished gamma ERD', 'WM performance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C3852967', 'cui_str': 'Transcranial Random Noise Stimulation'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2931783', 'cui_str': 'Enamel-renal syndrome'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}]",49.0,0.0357647,"Improvements in WM performance following tRNS were accompanied by increased theta ERS and diminished gamma ERD during WM encoding, which were significantly greater than those observed following anodal tDCS or sham stimulation.
","[{'ForeName': 'O W', 'Initials': 'OW', 'LastName': 'Murphy', 'Affiliation': 'Monash Alfred Psychiatry Research Centre, Central Clinical School, The Alfred and Monash University, Melbourne, Australia; Monash Institute of Cognitive and Clinical Neurosciences, School of Psychological Science and Monash Biomedical Imaging, Monash University, Melbourne, Australia; Epworth Centre for Innovation in Mental Health, Epworth Healthcare, Camberwell, VIC, Australia; Department of Psychiatry, Central Clinical School, Monash University, Melbourne, VIC, Australia. Electronic address: oscar.murphy@monash.edu.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Hoy', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare, Camberwell, VIC, Australia; Department of Psychiatry, Central Clinical School, Monash University, Melbourne, VIC, Australia. Electronic address: kate.hoy@monash.edu.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wong', 'Affiliation': 'Monash Institute of Cognitive and Clinical Neurosciences, School of Psychological Science and Monash Biomedical Imaging, Monash University, Melbourne, Australia; School of Psychology and Public Health, La Trobe University, Bundoora, VIC, Australia. Electronic address: d.wong@latrobe.edu.au.'}, {'ForeName': 'N W', 'Initials': 'NW', 'LastName': 'Bailey', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare, Camberwell, VIC, Australia; Department of Psychiatry, Central Clinical School, Monash University, Melbourne, VIC, Australia. Electronic address: neil.bailey@monash.edu.'}, {'ForeName': 'P B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare, Camberwell, VIC, Australia; Department of Psychiatry, Central Clinical School, Monash University, Melbourne, VIC, Australia. Electronic address: paul.fitzgerald@monash.edu.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Segrave', 'Affiliation': 'Brain and Mental Health Research Hub, School of Psychological Sciences and Monash Biomedical Imaging, Monash Institute of Cognitive and Clinical Neuroscience, Monash University, Clayton, Australia. Electronic address: rebecca.segrave@monash.edu.'}]",Brain stimulation,['10.1016/j.brs.2020.07.001']
1444,32659483,Non-invasive vagal nerve stimulation decreases brain activity during trauma scripts.,"BACKGROUND


Traumatic stress can have lasting effects on neurobiology and result in psychiatric conditions such as posttraumatic stress disorder (PTSD). We hypothesize that non-invasive cervical vagal nerve stimulation (nVNS) may alleviate trauma symptoms by reducing stress sympathetic reactivity. This study examined how nVNS alters neural responses to personalized traumatic scripts.
METHODS


Nineteen participants who had experienced trauma but did not have the diagnosis of PTSD completed this double-blind sham-controlled study. In three sequential time blocks, personalized traumatic scripts were presented to participants immediately followed by either sham stimulation (n = 8; 0-14 V, 0.2 Hz, pulse width = 5s) or active nVNS (n = 11; 0-30 V, 25 Hz, pulse width = 40 ms). Brain activity during traumatic scripts was assessed using High Resolution Positron Emission Tomography (HR-PET) with radiolabeled water to measure brain blood flow.
RESULTS


Traumatic scripts resulted in significant activations within the bilateral medial and orbital prefrontal cortex, premotor cortex, anterior cingulate, thalamus, insula, hippocampus, right amygdala, and right putamen. Greater activation was observed during sham stimulation compared to nVNS within the bilateral prefrontal and orbitofrontal cortex, premotor cortex, temporal lobe, parahippocampal gyrus, insula, and left anterior cingulate. During the first exposure to the trauma scripts, greater activations were found in the motor cortices and ventral visual stream whereas prefrontal cortex and anterior cingulate activations were more predominant with later script presentations for those subjects receiving sham stimulation.
CONCLUSION


nVNS decreases neural reactivity to an emotional stressor in limbic and other brain areas involved in stress, with changes over repeated exposures suggesting a shift from scene appraisal to cognitively processing the emotional event.",2020,"Greater activation was observed during sham stimulation compared to nVNS within the bilateral prefrontal and orbitofrontal cortex, premotor cortex, temporal lobe, parahippocampal gyrus, insula, and left anterior cingulate.",['Nineteen participants who had experienced trauma but did not have the diagnosis of PTSD completed this double-blind sham-controlled study'],"['invasive cervical vagal nerve stimulation (nVNS', 'active nVNS', 'nVNS']","['bilateral medial and orbital prefrontal cortex, premotor cortex, anterior cingulate, thalamus, insula, hippocampus, right amygdala, and right putamen', 'motor cortices and ventral visual stream whereas prefrontal cortex and anterior cingulate activations', 'Greater activation', 'Brain activity']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0699036', 'cui_str': 'Orbital'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0228202', 'cui_str': 'Premotor cortex'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0442540', 'cui_str': 'Stream'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",19.0,0.0708328,"Greater activation was observed during sham stimulation compared to nVNS within the bilateral prefrontal and orbitofrontal cortex, premotor cortex, temporal lobe, parahippocampal gyrus, insula, and left anterior cingulate.","[{'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Wittbrodt', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA. Electronic address: mattwittbrodt@emory.edu.'}, {'ForeName': 'Nil Z', 'Initials': 'NZ', 'LastName': 'Gurel', 'Affiliation': 'Department of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, USA.'}, {'ForeName': 'Jonathon A', 'Initials': 'JA', 'LastName': 'Nye', 'Affiliation': 'Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Ladd', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Md Mobashir H', 'Initials': 'MMH', 'LastName': 'Shandhi', 'Affiliation': 'Department of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, USA.'}, {'ForeName': 'Minxuan', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Amit J', 'Initials': 'AJ', 'LastName': 'Shah', 'Affiliation': 'Department of Medicine (Cardiology), Emory University School of Medicine, Atlanta, GA, USA; Atlanta VA Medical Center, Decatur, GA, USA.'}, {'ForeName': 'Bradley D', 'Initials': 'BD', 'LastName': 'Pearce', 'Affiliation': 'Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Zuhayr S', 'Initials': 'ZS', 'LastName': 'Alam', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Rapaport', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Murrah', 'Affiliation': 'Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Yi-An', 'Initials': 'YA', 'LastName': 'Ko', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Ammer A', 'Initials': 'AA', 'LastName': 'Haffer', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Lucy H', 'Initials': 'LH', 'LastName': 'Shallenberger', 'Affiliation': 'Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Vaccarino', 'Affiliation': 'Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA; Department of Medicine (Cardiology), Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Omer T', 'Initials': 'OT', 'LastName': 'Inan', 'Affiliation': 'Department of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, USA; Wallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology, Atlanta, GA, USA.'}, {'ForeName': 'J Douglas', 'Initials': 'JD', 'LastName': 'Bremner', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA; Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA; Atlanta VA Medical Center, Decatur, GA, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.07.002']
1445,32659637,Cost and cost-effectiveness of three strategies for implementing motivational interviewing for substance misuse on medical inpatient units.,"BACKGROUND


This study conducted cost and cost-effectiveness analyses of three strategies for implementing motivational interviewing for substance misuse on general medical inpatient units: workshop, apprenticeship, and consult.
METHODS


The economic analyses were conducted prospectively alongside a type 3 hybrid effectiveness-implementation randomized trial comprising 38 medical providers, 1173 inpatients, and four consultation-liaison motivational interviewing experts. The trial took place in a university affiliated teaching hospital in New Haven, CT, USA. After completing a 1-day workshop on motivational interviewing, providers were randomized to conditions. The primary outcome measure was the number of study-eligible patients who received a motivational interview. The economic analyses included the costs of both start-up and on-going activities in each condition. Incremental cost-effectiveness ratios were used to determine cost effectiveness. Results are presented from the healthcare provider (i.e., hospital) perspective in 2018 US dollars.
RESULTS


The total cost per patient receiving a motivational interview averaged $804.53, $606.52, and $185.65 for workshop, apprenticeship, and consult, respectively. Workshop and apprenticeship were extended dominated by the combination of consult and doing nothing. Doing nothing is cost effective when the willingness-to-pay for an additional patient receiving a motivational interview is less than $185.65, and consult is cost-effective when the willingness-to-pay for an additional patient receiving a motivational interview is greater than $185.65.
CONCLUSIONS


Given that typical reimbursements for brief intervention services for substance misuse are $35-$65, none of the three implementation strategies is likely to be economically viable from the healthcare provider perspective.",2020,"The total cost per patient receiving a motivational interview averaged $804.53, $606.52, and $185.65 for workshop, apprenticeship, and consult, respectively.","['substance misuse on medical inpatient units', '38 medical providers, 1173 inpatients, and four consultation-liaison motivational interviewing experts', 'university affiliated teaching hospital in New Haven, CT, USA']",['implementing motivational interviewing'],"['Cost and cost-effectiveness', 'Incremental cost-effectiveness ratios', 'total cost per patient receiving a motivational interview']","[{'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]",38.0,0.0294972,"The total cost per patient receiving a motivational interview averaged $804.53, $606.52, and $185.65 for workshop, apprenticeship, and consult, respectively.","[{'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Olmstead', 'Affiliation': 'The University of Texas at Austin, Lyndon B. Johnson School of Public Affairs, Sid Richardson Hall, Unit 3, Austin, TX, 78712, USA. Electronic address: tolmstead@austin.utexas.edu.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Yonkers', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, 300 George Street, Suite 901, New Haven, CT, 06520, USA; Yale School of Medicine, Department of Obstetrics, Gynecology & Reproductive Sciences, 333 Cedar Street, New Haven, CT, 06510, USA; Yale School of Epidemiology and Public Health Division of Chronic Disease, 60 College Street, New Haven, CT, 06520, USA.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Forray', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, 300 George Street, Suite 901, New Haven, CT, 06520, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Zimbrean', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, 300 George Street, Suite 901, New Haven, CT, 06520, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Gilstad-Hayden', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, 300 George Street, Suite 901, New Haven, CT, 06520, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Martino', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, 300 George Street, Suite 901, New Haven, CT, 06520, USA; VA Connecticut Healthcare System, Psychology Service, 950 Campbell Avenue (116B), West Haven, CT, 06516, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108156']
1446,32659641,A comparative study of autologous rectus fascia pubovaginal sling surgery and synthetic transobturator vaginal tape procedure in treatment of women with urodynamic stress urinary incontinence.,"OBJECTIVE


To compare short term results of autologous rectus fascia pubovaginal sling surgery with synthetic transobturator vaginal tape procedure in treatment of female stress urinary incontinence (SUI) STUDY DESIGN: It was a comparative study on 30 women between 25-65 years of age with urodynamic proven SUI who were randomly allocated to autologous rectus fascia pubovaginal sling surgery (Group I)(15 women) and synthetic transobturator vaginal tape procedure (Group II) (15 women). Preoperative and postoperative ICIQ (International Consultation on Incontinence Questionnaire) score, urodynamic study and serum CRP and IL-6 were done in all cases.
RESULTS


The baseline characteristics in terms of age, body mass index (BMI), parity, mean ICIQ score and mean preoperative CRP and IL-6 levels were similar in two groups. Mean operative time was significantly longer (55.60 ± 5.77 vs 25.27 ± 4.32 minutes, p = 0.001) in group I than group II. Mean hospital stay of 7.1 ± 1.2 vs 1.2 ± 0.4 days, mean duration of catheterization 5.8 vs 1.2 day (<0.01) and postoperative urinary retention requiring recathterization were all significantly higher in group I than II. Wound infection was more in group I than in group II (p = 0.01) while groin pain was significantly more in group II (p = 0.01). One patient developed vesicovaginal fistula, while one patient required cutting of tape in group I. Pdet at Q max (Detrusor pressure at peak urine flow) increased significantly in both the groups after surgery. ICIQ score was zero in both the groups indicating 100 % success. Surgical trauma was more in group I as shown by significantly higher CRP levels.
CONCLUSION


The success rate of the two groups was similar but, autologous rectus fascia sling surgery took longer, had more complications and urinary retention as compared to transobturator vaginal tape procedure.",2020,"Mean operative time was significantly longer (55.60 ± 5.77 vs 25.27 ± 4.32 minutes, p = 0.001) in group I than group II.","['Group II) (15 women', 'women with urodynamic stress urinary incontinence', '30 women between 25-65 years of age with urodynamic proven SUI', 'female stress urinary incontinence']","['autologous rectus fascia pubovaginal sling surgery (Group I)(15 women) and synthetic transobturator vaginal tape procedure', 'autologous rectus fascia pubovaginal sling surgery and synthetic transobturator vaginal tape procedure', 'autologous rectus fascia pubovaginal sling surgery with synthetic transobturator vaginal tape procedure']","['Preoperative and postoperative ICIQ ', 'Mean operative time', 'Mean hospital stay', 'ICIQ score', 'Surgical trauma', 'CRP and IL-6', 'Wound infection', 'postoperative urinary retention requiring recathterization', 'CRP levels', 'complications and urinary retention', 'groin pain', 'vesicovaginal fistula', 'mean duration of catheterization', 'success rate', 'body mass index (BMI), parity, mean ICIQ score and mean preoperative CRP and IL-6 levels', 'Incontinence Questionnaire) score, urodynamic study and serum']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0456369', 'cui_str': 'Proven'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0225234', 'cui_str': 'Structure of fascia of rectus abdominis muscle'}, {'cui': 'C0183346', 'cui_str': 'Sling'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0239783', 'cui_str': 'Inguinal pain'}, {'cui': 'C0042582', 'cui_str': 'Vesicovaginal fistula'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",30.0,0.0224989,"Mean operative time was significantly longer (55.60 ± 5.77 vs 25.27 ± 4.32 minutes, p = 0.001) in group I than group II.","[{'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India. Electronic address: jbsharma@aiims.ac.in.'}, {'ForeName': 'Manasi Kamalakar', 'Initials': 'MK', 'LastName': 'Deoghare', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Neerja', 'Initials': 'N', 'LastName': 'Bhatla', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Garima', 'Initials': 'G', 'LastName': 'Kachhawa', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Reeta', 'Initials': 'R', 'LastName': 'Mahey', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Kumari', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Amlesh', 'Initials': 'A', 'LastName': 'Seth', 'Affiliation': 'Department of Urology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Alpana', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Department of Biochemistry, All India Institute of Medical Sciences, New Delhi, India.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.06.062']
1447,32660126,Feasibility and Preliminary Effectiveness of a Tele-Prehabilitation Program in Esophagogastric Cancer Patients.,"Tele-rehabilitation provides better access to healthcare services and optimizes exercise adherence. However, its feasibility and effectiveness are unknown in the preoperative period in esophagogastric cancer patients. We aimed to assess the feasibility and the preliminary effects of a ""tele-prehabilitation"" program in esophagogastric cancer patients requiring surgery. Enrolled participants performed an internet-based tele-prehabilitation including aerobic, resistance and inspiratory muscle training over 2-4 weeks. The primary outcome was feasibility, measured in terms of recruitment, retention and attendance rates, adverse events and patient satisfaction. Secondary outcomes (functional exercise capacity, fatigue, quality of life, anxiety and depression) were assessed at baseline, presurgery, and 4 and 12 weeks postsurgery. Among the 24 eligible subjects, 23 were enrolled, 22 performed the intervention and 15 completed the study. Recruitment and retention rates were both 96%. Attendances to aerobic and resistance sessions and inspiratory muscle training were 77% and 68%, respectively. No adverse events occurred, and the satisfaction was excellent. After prehabilitation, participants significantly improved fatigue ( p  = 0.039), quality of life ( p  = 0.009), physical well-being ( p  = 0.034), emotional well-being ( p  = 0.005) and anxiety ( p  = 0.044). This study demonstrated the feasibility of a tele-prehabilitation in esophagogastric cancer patients undergoing surgery, with a high recruitment rate, retention rate and satisfaction, a good attendance to exercise sessions and no exercise-related adverse events.",2020,"After prehabilitation, participants significantly improved fatigue ( p  = 0.039), quality of life ( p  = 0.009), physical well-being ( p  = 0.034), emotional well-being ( p  = 0.005) and anxiety ( p  = 0.044).","['Esophagogastric Cancer Patients', 'esophagogastric cancer patients requiring surgery', 'esophagogastric cancer patients undergoing surgery, with a high recruitment rate, retention rate and satisfaction, a good attendance to exercise sessions and no exercise-related adverse events', 'esophagogastric cancer patients', '24 eligible subjects, 23 were enrolled, 22 performed the intervention and 15 completed the study']","['internet-based tele-prehabilitation including aerobic, resistance and inspiratory muscle training over 2-4 weeks', 'Tele-Prehabilitation Program', 'tele-prehabilitation"" program']","['quality of life', 'fatigue', 'anxiety', 'Recruitment and retention rates', 'recruitment, retention and attendance rates, adverse events and patient satisfaction', 'Attendances to aerobic and resistance sessions and inspiratory muscle training', 'adverse events', 'Secondary outcomes (functional exercise capacity, fatigue, quality of life, anxiety and depression']","[{'cui': 'C0475468', 'cui_str': 'Esophagogastric'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",23.0,0.0511008,"After prehabilitation, participants significantly improved fatigue ( p  = 0.039), quality of life ( p  = 0.009), physical well-being ( p  = 0.034), emotional well-being ( p  = 0.005) and anxiety ( p  = 0.044).","[{'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Piraux', 'Affiliation': 'Pôle de Neuro Musculo Skeletal Lab, Pôle de Pneumologie, ORL & Dermatologie, Institut de Recherche Expérimentale et Clinique, Clinical Neuroscience, Institute of Neurosciences, Université Catholique de Louvain, 1200 Brussels, Belgium.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Caty', 'Affiliation': 'Pôle de Neuro Musculo Skeletal Lab, Institut de Recherche Expérimentale et Clinique, Clinical Neuroscience, Institute of Neurosciences, Université Catholique de Louvain, Service de Médecine Physique et Réadaptation, Cliniques Universitaires Saint-Luc, 1200 Brussels, Belgium.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Reychler', 'Affiliation': 'Pôle de Pneumologie, ORL & Dermatologie, Institut de Recherche Expérimentale et Clinique, Université catholique de Louvain, Haute Ecole Léonard de Vinci, PARNASSE-ISEI, Secteur de kinésithérapie, Service de Pneumologie, Cliniques Universitaires Saint-Luc, 1200 Brussels, Belgium.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Forget', 'Affiliation': 'Institute of Applied Health Sciences, Epidemiology Group, University of Aberdeen, NHS Grampian, Department of Anaesthetics, Aberdeen AB25 2ZD, UK: forgetpatrice@yahoo.fr.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Deswysen', 'Affiliation': 'Upper Gastrointestinal Surgery Unit, Cliniques Universitaires Saint-Luc, 1200 Brussels, Belgium.'}]",Journal of clinical medicine,['10.3390/jcm9072176']
1448,32660667,Effect of oral or intragastric delivery of the bitter tastant quinine on food intake and appetite sensations: a randomised crossover trial.,"Stimulation of gastrointestinal taste receptors affects eating behaviour. Intraduodenal infusion of tastants leads to increased satiation and reduced food intake, whereas intraileal infusion of tastants does not affect eating behaviour. Currently, it is unknown whether oral- or intragastric administration of tastants induces a larger effect on eating behaviour. This study investigated the effects of oral- and/or intragastric administration of quinine on food intake, appetite sensations and heart rate variability (HRV). In a blinded randomised crossover trial, thirty-two healthy volunteers participated in four interventions with a 1-week washout: oral placebo and intragastric placebo (OPGP), oral quinine and intragastric placebo (OQGP), oral placebo and intragastric quinine (OPGQ) and oral quinine and intragastric quinine (OQGQ). On test days, 150 min after a standardised breakfast, subjects ingested a capsule containing quinine or placebo and were sham-fed a mixture of quinine or placebo orally. At 50 min after intervention, subjects received an ad libitum meal to measure food intake. Visual analogue scales for appetite sensations were collected, and HRV measurements were performed at regular intervals. Oral and/or intragastric delivery of the bitter tastant quinine did not affect food intake (OPGP: 3273·6 (sem 131·8) kJ, OQGP: 3072·7 (sem 132·2) kJ, OPGQ: 3289·0 (sem 132·6) kJ and OQGQ: 3204·1 (sem 133·1) kJ, P = 0·069). Desire to eat and hunger decreased after OQGP and OPGQ compared with OPGP (P < 0·001 and P < 0·05, respectively), whereas satiation, fullness and HRV did not differ between interventions. In conclusion, sole oral sham feeding with and sole intragastric delivery of quinine decreased desire to eat and hunger, without affecting food intake, satiation, fullness or HRV.",2020,"Desire to eat and hunger decreased after OQGP and OPGQ compared with OPGP (p<.001 and p<.05, respectively), whereas satiation, fullness and HRV did not differ between interventions.",['32 healthy volunteers participated in four interventions with a one-week washout: oral'],"['OQGQ', 'placebo/intragastric placebo (OPGP), oral quinine/intragastric placebo (OQGP), oral placebo/intragastric quinine (OPGQ), and oral quinine/intragastric quinine (OQGQ', 'OPGQ', 'OPGP', 'ad libitum meal to measure food intake', 'bitter tastant quinine', 'capsule containing quinine or placebo and were sham-fed a mixture of quinine or placebo']","['Desire to eat and hunger', 'food intake OPGP', 'food intake, appetite sensations, and heart rate variability (HRV', 'Visual analogue scales for appetite sensations', 'satiation, fullness and HRV', 'desire to eat and hunger, without affecting food intake, satiation, fullness, or HRV', 'food intake and appetite sensations']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0034417', 'cui_str': 'Quinine'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0235290', 'cui_str': 'Taste bitter'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}]","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",32.0,0.383977,"Desire to eat and hunger decreased after OQGP and OPGQ compared with OPGP (p<.001 and p<.05, respectively), whereas satiation, fullness and HRV did not differ between interventions.","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Klaassen', 'Affiliation': 'Food Innovation and Health, Centre for Healthy Eating and Food Innovation, Maastricht University, 5911 AAVenlo, The Netherlands.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Keszthelyi', 'Affiliation': 'Division of Gastroenterology-Hepatology, Department of Internal Medicine, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre, 6202AZ Maastricht, The Netherlands.'}, {'ForeName': 'Annick M E', 'Initials': 'AME', 'LastName': 'Alleleyn', 'Affiliation': 'Division of Gastroenterology-Hepatology, Department of Internal Medicine, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre, 6202AZ Maastricht, The Netherlands.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Wilms', 'Affiliation': 'Division of Gastroenterology-Hepatology, Department of Internal Medicine, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre, 6202AZ Maastricht, The Netherlands.'}, {'ForeName': 'Aalt', 'Initials': 'A', 'LastName': 'Bast', 'Affiliation': 'Food Innovation and Health, Centre for Healthy Eating and Food Innovation, Maastricht University, 5911 AAVenlo, The Netherlands.'}, {'ForeName': 'Adrian A M', 'Initials': 'AAM', 'LastName': 'Masclee', 'Affiliation': 'Division of Gastroenterology-Hepatology, Department of Internal Medicine, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre, 6202AZ Maastricht, The Netherlands.'}, {'ForeName': 'Freddy J', 'Initials': 'FJ', 'LastName': 'Troost', 'Affiliation': 'Food Innovation and Health, Centre for Healthy Eating and Food Innovation, Maastricht University, 5911 AAVenlo, The Netherlands.'}]",The British journal of nutrition,['10.1017/S0007114520002536']
1449,32660919,Directed vertebral manipulation is not better than generic vertebral manipulation in patients with chronic low back pain: a randomised trial.,"QUESTION


In people with chronic low back pain, what is the average effect of directing manipulation at the most painful lumbar level compared with generic manipulation of the spine?
DESIGN


Randomised controlled trial with concealed allocation, a blinded assessor and intention-to-treat analysis.
PARTICIPANTS


148 people with non-specific chronic low back pain with a minimum level of pain intensity of 3 points (measured from 0 to 10 on the Pain Numerical Rating Scale).
INTERVENTIONS


All participants received 10 spinal manipulation sessions over a 4-week period. The experimental group received treatment to the most painful segment of the lower back. The control group received treatment to the thoracic spine.
OUTCOME MEASURES


The primary outcome was pain intensity, measured at the end of the intervention (Week 4). Secondary outcomes were: pain intensity at Weeks 12 and 26; pressure pain threshold at Week 4; and global perceived change since onset and disability, both measured at Weeks 4, 12 and 26.
RESULTS


Each group was randomly allocated 74 participants. Data were collected at all time points for 71 participants (96%) in the experimental group and 72 (97%) in the control group. There were no clinically important between-group differences for pain intensity, disability or global perceived effect at any time point. The estimate of the effect of directing manipulation at the most painful lumbar level, as compared with generic manipulation, on pain intensity was too small to be considered clinically important: MD 0 (95% CI -0.9 to 0.9) at Week 4 and -0.1 (95% CI -1.0 to 0.8) at Week 26.
CONCLUSION


No clinically important differences were observed between directed manipulation and generic manipulation in people with chronic low back pain.
TRIAL REGISTRATION


NCT02883634.",2020,"There were no clinically important between-group differences for pain intensity, disability or global perceived effect at any time point.","['148 people with non-specific chronic low back pain with a minimum level of pain intensity of 3 points (measured from 0 to 10 on the Pain Numerical Rating Scale', 'people with chronic low back pain', 'patients with chronic low back pain']","['10 spinal manipulation sessions', 'Directed vertebral manipulation', 'generic vertebral manipulation']","['pain intensity', 'pain intensity at Weeks 12 and 26; pressure pain threshold at Week 4; and global perceived change since onset and disability', 'pain intensity, disability or global perceived effect']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449770', 'cui_str': 'Measured from'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",148.0,0.284812,"There were no clinically important between-group differences for pain intensity, disability or global perceived effect at any time point.","[{'ForeName': 'Ronaldo Fernando', 'Initials': 'RF', 'LastName': 'de Oliveira', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Leonardo Oliveira Pena', 'Initials': 'LOP', 'LastName': 'Costa', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, São Paulo, Brazil. Electronic address: lcos3060@gmail.com.'}, {'ForeName': 'Leonardo Penteado', 'Initials': 'LP', 'LastName': 'Nascimento', 'Affiliation': 'Escola de Osteopatia de Madrid Internacional, São Paulo, Brazil.'}, {'ForeName': 'Lívia Leticia', 'Initials': 'LL', 'LastName': 'Rissato', 'Affiliation': 'Physical Therapy Department, UBS Santo Antônio do Aracanguá, Santo Antônio do Aracanguá, Brazil.'}]",Journal of physiotherapy,['10.1016/j.jphys.2020.06.007']
1450,32676833,Correction to: Does Organizing Mentor-Mentee Matches into Small Groups Enhance Treatment Effects in a Site-Based Mentoring Program for Adolescents? Results of a Randomized Controlled Trial.,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,[],[],[],[],[],[],,0.0383541,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Shelley A', 'Initials': 'SA', 'LastName': 'Haddock', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA. shelley.haddock@colostate.edu.'}, {'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Weiler', 'Affiliation': 'University of Minnesota, St. Paul, MN, 55108, USA.'}, {'ForeName': 'Hyanghee', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Kimberly L', 'Initials': 'KL', 'LastName': 'Henry', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lucas-Thompson', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Toni S', 'Initials': 'TS', 'LastName': 'Zimmerman', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Krafchick', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Gereon F', 'Initials': 'GF', 'LastName': 'Fredrickson', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Yetz', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Lise M', 'Initials': 'LM', 'LastName': 'Youngblade', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}]",Journal of youth and adolescence,['10.1007/s10964-020-01283-1']
1451,32673766,Making sense of cross-trial comparisons for the frontline treatment of advanced-stage Hodgkin lymphoma.,,2020,,['advanced-stage Hodgkin lymphoma'],[],[],"[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0019829', 'cui_str': 'Hodgkin lymphoma'}]",[],[],,0.0468669,,"[{'ForeName': 'Deepesh P', 'Initials': 'DP', 'LastName': 'Lad', 'Affiliation': 'Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India. Electronic address: deepesh.lad12@gmail.com.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.05.012']
1452,32674155,"Corrigendum to: ""Sustained Long-Term Outcomes With Closed-Loop Spinal Cord Stimulation: 12-Month Results of the Prospective, Multicenter, Open-Label Avalon Study"" by Russo et al. Neurosurgery, 2020, nyaa003, https://doi.org/10.1093/neuros/nyaa003.",,2020,,[],['Closed-Loop Spinal Cord Stimulation'],[],[],"[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}]",[],,0.0133076,,[],Neurosurgery,['10.1093/neuros/nyaa332']
1453,32673160,Adaptations to exercise in compensators and noncompensators in the E-MECHANIC Trial.,"Rating of perceived exertion (RPE) and respiratory exchange ratio (RER) have previously been associated with acute exercise compensation. This study examined adaptations in the RPE and RER with long-term exercise training in individuals who did (noncompensators) and did not (compensators) lose the expected amount of weight. Participants ( n  = 110, 71.8% women, means ± SD; age 49 ± 12 yr) completed 24 wk of supervised exercise training at 65-85% V̇o 2peak  to achieve a prescribed dose of 8 kcal·kg body wt -1 ·wk -1  (8 KKW) or 20 KKW. Participants were categorized as noncompensators ( n  = 55) or compensators ( n  = 55) based on the percent of expected weight loss (%EWL) achieved. Changes in RPE and RER during exercise over time (baseline,  week 12 ,  week 24 ) were compared by weight compensation category. Individual %EWL in relation to RPE, RER, and training intensity (%V̇o 2peak ) was evaluated over the same time period. RPE and RER for a given workload decreased from baseline to  week 12  and stabilized through  week 24 , regardless of weight compensation (time  P  < 0.0001). Noncompensators had a higher RPE relative to heart rate, which was partly explained by higher %V̇o 2peak . RPE and %V̇o 2peak  both positively predicted %EWL, independent of age, sex, and exercise dose. Training intensity and RPE were positively associated with weight loss on the individual level, warranting further investigation into self-selection in exercise-based programs. Understanding individual heterogeneity in training intensity and behavioral responses may improve future weight management efforts that involve exercise. NEW & NOTEWORTHY  In sedentary individuals with overweight and obesity, achievement of expected weight loss from long-term exercise training was associated with individual adaptations in perceived exertion. Contrary to our hypothesis, those with higher relative perceived exertion achieved a larger proportion of their expected weight loss, which was partly explained by a higher self-selected exercise training intensity.",2020,"Non-compensators had a higher RPE relative to heart rate, which was partly explained by higher %VO 2peak .","['Participants (n = 110, 71.8% F, mean ± SD age 49 ± 12 years) completed 24 weeks of', 'Participants were categorized as non-compensators (n=55) or compensators (n=55) based on the percent of expected weight loss (%EWL) achieved', 'individuals who did (non-compensators) and did not (compensators']","['supervised exercise training at 65-85% VO 2peak  to achieve a prescribed dose of 8 kcal/kg body weight/week (8 KKW) or 20 KKW', 'RER with long-term exercise training', 'Perceived Exertion (RPE) and respiratory exchange ratio (RER']","['weight loss', 'RPE relative to heart rate']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0560602', 'cui_str': 'kcal/kg body weight'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.0200206,"Non-compensators had a higher RPE relative to heart rate, which was partly explained by higher %VO 2peak .","[{'ForeName': 'S Nicole', 'Initials': 'SN', 'LastName': 'Fearnbach', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Johannsen', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'Candice A', 'Initials': 'CA', 'LastName': 'Myers', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Apolzan', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Johnson', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'Conrad P', 'Initials': 'CP', 'LastName': 'Earnest', 'Affiliation': 'Texas A&M University, College Station, Texas.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Rood', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'Catrine', 'Initials': 'C', 'LastName': 'Tudor-Locke', 'Affiliation': 'University of North Carolina Charlotte, Charlotte, North Carolina.'}, {'ForeName': 'Melissa N', 'Initials': 'MN', 'LastName': 'Harris', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Church', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00826.2019']
1454,32673274,"Development of ""Advancing People of Color in Clinical Trials Now!"": Web-Based Randomized Controlled Trial Protocol.","BACKGROUND


Participation in clinical trials among people of color remains low, compared with white subjects. This protocol describes the development of ""Advancing People of Color in Clinical Trials Now!"" (ACT Now!), a culturally tailored website designed to influence clinical trial decision making among people of color.
OBJECTIVE


This cluster randomized study aims to test the efficacy of a culturally tailored website to increase literacy, self-efficacy, and willingness to enroll in clinical trials among people of color.
METHODS


ACT Now! is a randomized trial including 2 groups: (1) intervention group (n=50) with access to the culturally tailored website and (2) control group (n=50) exposed to a standard clinical recruitment website. Clinical trial literacy and willingness to enroll in a clinical trial will be measured before and after exposure to the website corresponding to their assigned group (intervention or control). Surveys will be conducted at baseline and during the 1-month postintervention and 3-month follow-up. Website architecture and wireframing will be informed by the literature and experts in the field. Statistical analysis will be conducted using a two-tailed t test, with 80% power, at .05 alpha level, to increase clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials 3 months post intervention.
RESULTS


We will design a culturally tailored website that will provide leverage for community stakeholders to influence clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials among racial and ethnic groups. ACT Now! applies a community-based participatory research approach through the use of a community steering committee (CSC). The CSC provides input during the research study conception, development, implementation, and enrollment. CSC relationships help foster trust among communities of color. ACT Now! has the potential to fill a gap in clinical trial enrollment among people of color through an accessible web-based website. This study was funded in July 2017 and obtained institutional review board approval in spring 2017. As of December 2019, we had enrolled 100 participants. Data analyses are expected to be completed by June 2020, and expected results are to be published in fall 2020.
CONCLUSIONS


ACT Now! has the potential to fill an important gap in clinical trial enrollment among people of color through an accessible web-based website.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03243071; https://clinicaltrials.gov/ct2/show/NCT00102401.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17589.",2020,ACT Now! has the potential to fill a gap in clinical trial enrollment among people of color through an accessible web-based website.,"['As of December 2019, we had enrolled 100 participants', 'ACT', 'people of color']","['intervention group (n=50) with access to the culturally tailored website and (2) control group (n=50) exposed to a standard clinical recruitment website', 'culturally tailored website', 'ACT']","['clinical trial literacy, self-efficacy, and willingness']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009393', 'cui_str': 'Color'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}]","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",100.0,0.157381,ACT Now! has the potential to fill a gap in clinical trial enrollment among people of color through an accessible web-based website.,"[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Chung', 'Affiliation': 'NYU Grossman School of Medicine, New York, NY, United States.'}, {'ForeName': 'Azizi', 'Initials': 'A', 'LastName': 'Seixas', 'Affiliation': 'NYU Grossman School of Medicine, New York, NY, United States.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': 'NYU Grossman School of Medicine, New York, NY, United States.'}, {'ForeName': 'Yalini', 'Initials': 'Y', 'LastName': 'Senathirajah', 'Affiliation': 'University of Pittsburgh, Department of Biomedical Informatics, Pittsburgh, PA, United States.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Robbins', 'Affiliation': ""Brigham and Women's, Boston, MA, United States.""}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Newsome Garcia', 'Affiliation': 'Morehouse School of Medicine, Atlanta, GA, United States.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Ravenell', 'Affiliation': 'NYU Grossman School of Medicine, New York, NY, United States.'}, {'ForeName': 'Girardin', 'Initials': 'G', 'LastName': 'Jean-Louis', 'Affiliation': 'NYU Grossman School of Medicine, New York, NY, United States.'}]",JMIR research protocols,['10.2196/17589']
1455,32687924,"Intake of Lactiplantibacillus plantarum HEAL9 reduces the inflammatory markers soluble fractalkine and CD163 during acute stress: A randomized, double blind, placebo-controlled study.","The intestine and the brain are connected via the brain-gut axis and the intestinal microbiota influences the immune activation and signaling molecules that are involved in the stress response. The aim of the study was to investigate if intake of the probiotic strain Lactiplantibacillus plantarum HEAL9 (LPHEAL9) for four weeks could counteract elevated cortisol and inflammation levels in subjects with chronic stress that are exposed to an acute stress test (Trier Social Stress Test, TSST). Seventy participants were included, and 63 participants completed the study (LPHEAL9, n = 32; placebo, n  =  31). Cardiovascular reactivity and cortisol levels were affected by the TSST, but no differences between the groups were observed. Intake of LPHEAL9 did, however, result in significantly decreased plasma levels of two inflammatory markers (soluble fractalkine and CD163) compared to placebo. In conclusion, intake of LPHEAL9 for four weeks may reduce inflammatory markers coupled to acute stress in chronically stressed individuals.",2020,"Intake of LPHEAL9 did, however, result in significantly decreased plasma levels of two inflammatory markers (soluble fractalkine and CD163) compared to placebo.","['acute stress', 'subjects with chronic stress', 'chronically stressed individuals', 'Seventy participants were included, and 63 participants completed the study (LPHEAL9, n=32; placebo, n=31']","['probiotic strain Lactobacillus plantarum HEAL9 (LPHEAL9', 'Lactobacillus plantarum HEAL9', 'placebo']","['elevated cortisol and inflammation levels', 'plasma levels', 'Cardiovascular reactivity and cortisol levels']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]",70.0,0.191303,"Intake of LPHEAL9 did, however, result in significantly decreased plasma levels of two inflammatory markers (soluble fractalkine and CD163) compared to placebo.","[{'ForeName': 'Gunilla', 'Initials': 'G', 'LastName': 'Önning', 'Affiliation': 'Biomedical Nutrition, Pure and Applied Biochemistry, Lund University, Lund, Sweden; Probi AB, Lund, Sweden. Electronic address: gunilla.onning@probi.com.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Hillman', 'Affiliation': 'Department of Clinical Sciences Lund, Diabetes Research Laboratory, Lund University, Lund, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hedin', 'Affiliation': 'Department of Food Technology, Engineering and Nutrition, Lund University, Lund, Sweden.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Montelius', 'Affiliation': 'Probi AB, Lund, Sweden.'}, {'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Eriksson', 'Affiliation': 'Ergonomics and Aerosol Technology, Department of Design Studies, Lund University, Lund, Sweden.'}, {'ForeName': 'Siv', 'Initials': 'S', 'LastName': 'Ahrné', 'Affiliation': 'Department of Food Technology, Engineering and Nutrition, Lund University, Lund, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jönsson', 'Affiliation': 'Department of Psychology, Faculty of Education, Kristianstad University, Kristianstad, Sweden.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113083']
1456,32679370,Early application of caffeine improves white matter development in very preterm infants.,"The aim of this study was to evaluate the effect of early prophylactic caffeine treatment on white matter development in very preterm infants using cerebral magnetic resonance imaging. A total of 194 preterm infants (≤32 weeks gestational age) were randomly assigned to the caffeine (n = 96) or placebo (n = 93) treatment group and administered with either caffeine or placebo within 72 h after birth. Cerebral magnetic resonance imaging, including diffuse tensor imaging examination, was performed at 34-36 weeks of corrected gestational age, and the fractional anisotropy (FA) and apparent diffusion coefficient (ADC) values were measured. In total, 160 infants were included in the final analysis, including 80 cases in the placebo group and 80 cases in the caffeine group. There were fewer instances of apnea of prematurity and shorter assisted ventilation times for infants in the caffeine group compared to the placebo group (p < 0.05). Infants in the caffeine group had significantly higher FA values in white matter, including the posterior limb of the internal capsule, the corpus callosum, the frontal, occipital, and parietal white matter, the cerebellum, and the cerebral peduncle, compared to infants in the placebo group. ADC values in the above white matter areas were significantly reduced in the caffeine group. However, there were no significant differences regarding the FA and ADC in the gray matter between the two groups. These results demonstrate that early administration of caffeine improves white matter micro-structural development in preterm infants, but with no significant effect on short-term complications related to prematurity.",2020,"Infants in the caffeine group had significantly higher FA values in white matter, including the posterior limb of the internal capsule, the corpus callosum, the frontal, occipital, and parietal white matter, the cerebellum, and the cerebral peduncle, compared to infants in the placebo group.","['very preterm infants', 'very preterm infants using cerebral magnetic resonance imaging', 'preterm infants', '194 preterm infants (≤32 weeks gestational age', '160 infants were included in the final analysis, including 80 cases in the placebo group and 80 cases in the caffeine group']","['placebo', 'caffeine', 'caffeine or placebo', 'prophylactic caffeine']","['white matter micro-structural development', 'apnea of prematurity and shorter assisted ventilation times', 'FA values', 'fractional anisotropy (FA) and apparent diffusion coefficient (ADC) values', 'FA and ADC', 'ADC values']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0475715', 'cui_str': 'Apnea of prematurity'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}]",194.0,0.144528,"Infants in the caffeine group had significantly higher FA values in white matter, including the posterior limb of the internal capsule, the corpus callosum, the frontal, occipital, and parietal white matter, the cerebellum, and the cerebral peduncle, compared to infants in the placebo group.","[{'ForeName': 'Shasha', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Yanchao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Brain Imaging, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Ruili', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Xiaoan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Brain Imaging, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China; Center for Perinatal Medicine and Health, Institute of Neuroscience and Physiology, Sahlgrenska Academy, Gothenburg University, Gothenburg 40530, Sweden.'}, {'ForeName': 'Falin', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Changlian', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': ""Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China; Center for Brain Repair and Rehabilitation, Institute of Neuroscience and Physiology, Sahlgrenska Academy, Gothenburg University, Gothenburg 40530, Sweden; Department of Women's and Children's Health, Karolinska Institutet, Stockholm 17177, Sweden. Electronic address: changlian.zhu@neuro.gu.se.""}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103495']
1457,32679403,"Commentary on Liu, K. et al. (2018). Handgrip exercise reduces peripherally-inserted central catheter-related venous thrombosis in patients with solid cancers: A randomized controlled trial.",,2020,,['patients with solid cancers'],['Handgrip exercise reduces peripherally-inserted central catheter-related venous thrombosis'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}]",[],,0.162369,,"[{'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Wen', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Guangxi Medical University, No. 6, Shuangyong Road, 530021 Nanning, Guangxi, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Ying', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Guangxi Medical University, No. 6, Shuangyong Road, 530021 Nanning, Guangxi, China. Electronic address: yanpingying0116@126.com.'}, {'ForeName': 'Jianpeng', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Medicine, The First Affiliated Hospital of Guangxi Medical University, No. 6, Shuangyong Road, 530021 Nanning, Guangxi, China.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103691']
1458,32662200,Comparison of the effectiveness of simple carbohydrates on hypoglycemic episodes in children and adolescents with type 1 diabetes mellitus: A randomized study in a diabetes camp.,"BACKGROUND


Hypoglycemia is the most common and severe complication of insulin treatment during the management of type 1 diabetes mellitus (T1DM). Despite its importance, there is a lack of data about the efficacy and superiority of the carbohydrate sources used in hypoglycemia management in children and adolescents.
OBJECTIVE


We aimed to compare the effectiveness of honey, fruit juice, and sugar cubes as simple carbohydrates used in the primary treatment of hypoglycemia in children and adolescents with T1DM, who attended a diabetes summer camp.
METHODS


A prospective randomized study was performed in a 5-days-long diabetes summer camp. Three different types of simple carbohydrates; sugar cubes, honey, or fruit juice were randomly given for the treatment of hypoglycemia and the recovery results in the three groups were compared.
RESULTS


About 32 patients (53.1% male, mean age 12.9 ± 1.9 years) were included and 158 mild hypoglycemic episodes were observed. Sugar cubes, honey, and fruit juice were given in 46 (29.1%), 60 (37.9%), and 52 (33%) events, respectively. We found that honey and fruit juice had similar efficiency in recovering hypoglycemia in 15 minutes with a rate of 95% and 98%, respectively. However, sugar cubes had a significantly lower impact on treatment of hypoglycemia than the others, with a recovery rate of 84.7% at 15 minutes.
CONCLUSIONS


This study showed, for the first time, that honey and fruit juice were more effective in treating hypoglycemia than sugar cubes, and can be preferred in treating hypoglycemic events in children and adolescents with T1DM.",2020,"However, sugar cubes had a significantly lower impact on treatment of hypoglycemia than the others, with a recovery rate of 84.7% at 15 minutes.
","['children and adolescents with T1DM, who attended a diabetes summer camp', 'Thirty-two patients (53.1% male, mean age 12.9±1.9\u2009years) were included and 158 mild hypoglycemic episodes', 'children and adolescents with T1DM', 'Children and Adolescents with Type 1 Diabetes Mellitus', 'a Diabetes Camp', 'five-days-long diabetes summer camp', 'children and adolescents']","['honey, fruit juice and sugar cubes', 'Simple Carbohydrates']","['recovering hypoglycemia', 'hypoglycemia', 'Hypoglycemic Episodes', 'Sugar cubes, honey and fruit juice', 'recovery rate']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycaemic episode'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205166', 'cui_str': 'Long'}]","[{'cui': 'C0019906', 'cui_str': 'Honey'}, {'cui': 'C0452453', 'cui_str': 'Fruit juice'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205352', 'cui_str': 'Simple'}]","[{'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycaemic episode'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0019906', 'cui_str': 'Honey'}, {'cui': 'C0452453', 'cui_str': 'Fruit juice'}]",,0.0307224,"However, sugar cubes had a significantly lower impact on treatment of hypoglycemia than the others, with a recovery rate of 84.7% at 15 minutes.
","[{'ForeName': 'Ibrahim Mert', 'Initials': 'IM', 'LastName': 'Erbas', 'Affiliation': 'Division of Pediatric Endocrinology, Faculty of Medicine, Dokuz Eylül University, İzmir, Turkey.'}, {'ForeName': 'Ayhan', 'Initials': 'A', 'LastName': 'Abaci', 'Affiliation': 'Division of Pediatric Endocrinology, Faculty of Medicine, Dokuz Eylül University, İzmir, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Anik', 'Affiliation': 'Division of Pediatric Endocrinology, Faculty of Medicine, Adnan Menderes University, Aydın, Turkey.'}, {'ForeName': 'Erdem', 'Initials': 'E', 'LastName': 'Simsek', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Dokuz Eylül University, İzmir, Turkey.'}, {'ForeName': 'Hale Unver', 'Initials': 'HU', 'LastName': 'Tuhan', 'Affiliation': 'Division of Pediatric Endocrinology, Faculty of Medicine, Dokuz Eylül University, İzmir, Turkey.'}, {'ForeName': 'Cemil', 'Initials': 'C', 'LastName': 'Kocyigit', 'Affiliation': 'Division of Pediatric Endocrinology, Tepecik Training and Research Hospital, İzmir, Turkey.'}, {'ForeName': 'Melek', 'Initials': 'M', 'LastName': 'Yıldız', 'Affiliation': ""Division of Pediatric Endocrinology, Dr Behçet Uz Children's Hospital, İzmir, Turkey.""}, {'ForeName': 'Bumin Nuri', 'Initials': 'BN', 'LastName': 'Dundar', 'Affiliation': 'Division of Pediatric Endocrinology, Faculty of Medicine, İzmir Kâtip Çelebi University, İzmir, Turkey.'}, {'ForeName': 'Ece', 'Initials': 'E', 'LastName': 'Bober', 'Affiliation': 'Division of Pediatric Endocrinology, Faculty of Medicine, Dokuz Eylül University, İzmir, Turkey.'}, {'ForeName': 'Gonul', 'Initials': 'G', 'LastName': 'Catli', 'Affiliation': 'Division of Pediatric Endocrinology, Faculty of Medicine, İzmir Kâtip Çelebi University, İzmir, Turkey.'}]",Pediatric diabetes,['10.1111/pedi.13077']
1459,32667105,Culturally tailored evidence-based substance use disorder treatments are efficacious with an American Indian Southwest tribe: an open-label pilot-feasibility randomized controlled trial.,"BACKGROUND AND AIMS


Many evidence-based treatments (EBTs) for substance use disorder (SUD) exist, yet few are tailored to Indigenous patients. This trial tested the efficacy of a culturally tailored EBT that combined Motivational Interviewing and the Community Reinforcement Approach (MICRA) versus treatment as usual (TAU).
DESIGN


A mixed efficacy/effectiveness randomized controlled trial of MICRA (n = 38) and TAU (n = 41) using a parallel design with follow-up assessments at 4-, 8-, and 12- months post baseline.
SETTING


United States, reservation-based outpatient, addiction specialty care treatment program.
PARTICIPANTS


79 (68% male) American Indian and Alaska Native (AI/AN) Tribal members meeting criteria for SUD and seeking SUD treatment.
INTERVENTIONS


MICRA (individual therapy sessions beginning with MI for 2-3 sessions) compared with TAU (individual and group counseling sessions in a didactic style with Twelve-Step philosophy and elements of relapse prevention).
MEASURES


Demographics, percent days abstinent (PDA; the primary outcome at 12months assessed by Form 90D), Inventory of Drug Use Consequences, Alcohol and Drug Use Self-Efficacy Scale, Native American Spirituality Scale, and SCID-DSM-IV-TR.
FINDINGS


There was no evidence for the benefit of MICRA over TAU (MICRA PDA = 72.63%, TAU = 73.62%, treatment effect: B = -4.04 (SE = 5.47); 95% CI = -14.941, 6.866; BF = 3.44) in the primary outcome. Both groups showed improvements in PDA, SUD severity, and negative consequences from baseline to the 12-month follow-up. Neither self-efficacy nor spirituality were significant mediators of MICRA.
CONCLUSIONS


There were no treatment group differences between culturally tailored evidence-based treatments for substance use disorder and treatment as usual in this randomized controlled trial with American Indian and Alaska Native participants. Nonetheless, participants improved over time on several substance-related outcomes.",2020,"Both groups showed improvements in PDA, SUD severity, and negative consequences from baseline to the 12-month follow-up.","['79 (68% male) American Indian and Alaska Native (AI/AN', 'United States, reservation-based outpatient, addiction specialty care treatment program', 'n=38) and TAU (n=41', 'American Indian and Alaska Native participants', 'Tribal members meeting criteria for SUD and seeking SUD treatment', 'American Indian Southwest Tribe']","['MICRA', 'Culturally Tailored Evidence-based Substance Use Disorder Treatments', 'culturally tailored EBT that combined motivational interviewing and the Community Reinforcement Approach (MICRA) versus Treatment as Usual (TAU', 'MICRA (individual therapy sessions beginning with MI for 2 to 3 sessions) compared with TAU (individual and group counseling sessions']","['Form 90D), Inventory of Drug Use Consequences, Alcohol and Drug Use Self-Efficacy Scale, Native American Spirituality Scale, and SCID-DSM-IV-TR', 'PDA, SUD severity, and negative consequences']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0040881', 'cui_str': 'Tribes'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0204525', 'cui_str': 'Individual psychotherapy'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0237547', 'cui_str': 'Group counseling'}]","[{'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0237104', 'cui_str': 'Spirituality'}, {'cui': 'C0085110', 'cui_str': 'Severe combined immunodeficiency disease'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",,0.107365,"Both groups showed improvements in PDA, SUD severity, and negative consequences from baseline to the 12-month follow-up.","[{'ForeName': 'Kamilla L', 'Initials': 'KL', 'LastName': 'Venner', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, New Mexico, USA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Serier', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, New Mexico, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Sarafin', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, New Mexico, USA.'}, {'ForeName': 'Brenna L', 'Initials': 'BL', 'LastName': 'Greenfield', 'Affiliation': 'University of Minnesota, Duluth Medical School, Duluth, Minnesota, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Hirchak', 'Affiliation': 'Center on Alcoholism, Substance Abuse, and Addiction, Albuquerque, New Mexico, USA.'}, {'ForeName': 'Jane Ellen', 'Initials': 'JE', 'LastName': 'Smith', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, New Mexico, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, New Mexico, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15191']
1460,32663055,Exploring the Impact of Mindfulness on False-Memory Susceptibility.,"Wilson, Mickes, Stolarz-Fantino, Evrard, and Fantino (2015) presented data from three well-powered experiments suggesting that a brief mindfulness induction can increase false-memory susceptibility. However, we had concerns about some of the methodology, including whether mind wandering is the best control condition for brief mindfulness inductions. Here, we report the findings from a preregistered double-blind randomized controlled trial designed to replicate and extend Wilson et al.'s findings. Participants ( N  = 287) underwent 15-min mindfulness or mind-wandering inductions or completed a join-the-dots task before being presented with lists of words related to nonpresented critical lures. This was followed by free-recall and recognition tasks. There was no evidence for an effect of state of mind on correct or false recall or recognition. Furthermore, manipulation checks revealed that mindfulness and mind-wandering inductions activated overlapping states of mind. Exploratory analyses provided some support for mindfulness increasing false memory, but it appears that mind wandering may not be the right control for brief mindfulness research.",2020,There was no evidence for an effect of state of mind on correct or false recall or recognition.,['Participants ( N  = 287) underwent'],['15-min mindfulness or mind-wandering inductions or completed a join-the-dots task before being presented with lists of words related to nonpresented critical lures'],"['false-memory susceptibility', 'False-Memory Susceptibility']","[{'cui': 'C4517682', 'cui_str': '287'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0233569', 'cui_str': 'Wandering'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}]","[{'cui': 'C0561845', 'cui_str': 'False memories'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}]",,0.0455014,There was no evidence for an effect of state of mind on correct or false recall or recognition.,"[{'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sherman', 'Affiliation': 'School of Psychology, Keele University.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Grange', 'Affiliation': 'School of Psychology, Keele University.'}]",Psychological science,['10.1177/0956797620929302']
1461,32663479,The Effect of Proprioceptive Exercises on Balance and Physical Function in Institutionalized Older Adults: A Randomized Controlled Trial.,"OBJECTIVES


To evaluate the efficacy of a proprioceptive exercise program on functional mobility, musculoskeletal endurance, dynamic and static balance, gait, and risk of falls in institutionalized older adults.
DESIGN


Randomized, single-blind, controlled trial.
SETTING


A Spanish nursing home in the autonomous community of Extremadura, Spain.
PARTICIPANTS


An initial sample was created by recruiting 148 older adult volunteers. The final sample (N=42) was randomly divided into 2 groups.
INTERVENTIONS


Both the control and experimental group received physical therapy treatment based on a combination of adapted exercises and other physical therapy techniques (physical therapy intervention program) for a period of 12 weeks. This program consisted of 45 minutes (group intervention) plus 100 minutes (individual intervention) a week, for a total of 36 sessions (29 hours). The experimental group received a proprioceptive training program during the same intervention period, which was conducted twice weekly (24 sessions), with each session lasting 55 minutes.
MAIN OUTCOME MEASURES


Timed Up and Go (TUG), Cooper, Tinetti, 1-leg stance, and the Morse Fall Scale (MFS).
RESULTS


Analysis of variance showed a time × group interaction in TUG score (F=10.41, P=.002), Cooper test (F=5.94, P=.019), Tinetti score (F=6.41, P=.015), and MFS scores (F=5.24, P=.028). Differences between groups were achieved for TUG scores (d=0.76), Tinetti scores (d=1.12), 1-leg stance test scores (d=0.77), and MFS scale scores (d=0.85). In the experimental group, within-group analyses showed pre- to post-treatment differences for TUG scores (d=0.72), Cooper test scores in meters (d=0.18), Tinetti scores (d=0.60), 1-leg stance scores (d=0.55), and MFS scores (d=0.42).
CONCLUSIONS


A proprioceptive exercise program demonstrated significant improvements compared with the control group in areas such as functional mobility, musculoskeletal endurance, balance, gait, and risk of falls in institutionalized older adults. This study may help to enhance our understanding of the impact of a specific protocol for a proprioceptive rehabilitation program.",2020,"A proprioceptive exercise program produced significant improvements compared to the control group in areas such as functional mobility, musculoskeletal endurance, balance, gait, and risk of falls in institutionalized older adults.","['institutionalized older adults', '148 older adult volunteers', 'A Spanish nursing home from the Autonomous Community of Extremadura, Spain']","['physical therapy treatment based on a combination of adapted exercises and other physical therapy techniques (physical therapy intervention program', 'proprioceptive exercises', 'proprioceptive exercise program', 'proprioceptive training program']","['functional mobility, musculoskeletal endurance, balance, gait, and risk of falls', 'functional mobility, musculoskeletal endurance, dynamic and static balance, gait, and risk of falls', 'Tinetti scores', 'Cooper test', 'MORSE scores', 'TUG scores', 'balance and physical function', 'MORSE scale scores', 'One-Leg Stance test scores', 'time x group interaction in TUG scores', 'One-Leg Stance scores']","[{'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0949766', 'cui_str': 'Physical therapy procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0029709', 'cui_str': 'Other physical therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0454280', 'cui_str': 'Proprioceptive exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0335912', 'cui_str': 'Cooper'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",148.0,0.0221272,"A proprioceptive exercise program produced significant improvements compared to the control group in areas such as functional mobility, musculoskeletal endurance, balance, gait, and risk of falls in institutionalized older adults.","[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Espejo-Antúnez', 'Affiliation': 'Department of Medical-Surgical Therapy, Medicine Faculty, Extremadura University, Badajoz, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Pérez-Mármol', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, University of Granada, Granada, Spain. Electronic address: josemapm@ugr.es.'}, {'ForeName': 'M de Los Ángeles', 'Initials': 'MLÁ', 'LastName': 'Cardero-Durán', 'Affiliation': 'Puente Real II Healthcare Center, Avda. Federico Mayor Zaragoza, Badajoz, Spain.'}, {'ForeName': 'José Vicente', 'Initials': 'JV', 'LastName': 'Toledo-Marhuenda', 'Affiliation': 'Department of Pathology and Surgery, Area of Physiotherapy, Medicine Faculty, Miguel Hernández University, Alicante, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Albornoz-Cabello', 'Affiliation': 'Department of Physiotherapy, University of Sevilla, Sevilla, Spain.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.06.010']
1462,32664548,Effects of Elastic Resistance Exercise on Postoperative Outcomes Linked to the ICF Core Sets for Osteoarthritis after Total Knee Replacement in Overweight and Obese Older Women with Sarcopenia Risk: A Randomized Controlled Trial.,"(1) Background: Knee osteoarthritis (KOA) and aging are associated with high sarcopenia risk; sarcopenia may further affect outcomes after total knee replacement (TKR). Elastic resistance exercise training (RET) limits muscle attenuation in older adults. We aimed to identify the effects of post-TKR elastic RET on lean mass (LM) and functional outcomes in overweight and obese older women with KOA by using the brief International Classification of Functioning, Disability and Health Core Set for osteoarthritis (Brief-ICF-OA). (2) Methods: Eligible women aged ≥60 years who had received unilateral primary TKR were randomly divided into an experimental group (EG), which received postoperative RET twice weekly for 12 weeks, and a control group (CG), which received standard care. The primary and secondary outcome measures were LM and physical capacity, respectively, and were linked to the Brief-ICF-OA. The assessment time points were 2 weeks prior to surgery (T 0 ) and postoperative at 1 month (T 1 ; before RET) and 4 months (T 2 ; upon completion of RET) of follow-up. An independent t test with an intention-to-treat analysis was conducted to determine the between-group differences in changes of outcome measures at T 1  and T 2  from T 0 . (3) Results: Forty patients (age: 70.9 ± 7.3 years) were randomly assigned to the EG ( n  = 20) or CG ( n  = 20). At T 2 , the EG exhibited significantly greater improvements in leg LM (mean difference (MD) = 0.86 kg,  p  = 0.004) and gait speed (MD = 0.26 m/s,  p  = 0.005) compared with the CG. Furthermore, the EG generally obtained significantly higher odds ratios than the CG for treatment success for most Brief-ICF-OA categories (all  p  < 0.001). Conclusions: Early intervention of elastic RET after TKR yielded positive postoperative outcomes based on the Brief-ICF-OA. The findings of this study may facilitate clinical decision-making regarding the optimal post-TKR rehabilitation strategy for older women with KOA.",2020,"At T 2 , the EG exhibited significantly greater improvements in leg LM (mean difference (MD) = 0.86 kg,  p  = 0.004) and gait speed (MD = 0.26 m/s,  p  = 0.005) compared with the CG.","['Osteoarthritis after Total Knee Replacement in Overweight and Obese Older Women with Sarcopenia Risk', 'older adults', 'Forty patients (age: 70.9 ± 7.3 years', 'overweight and obese older women with KOA by using the brief International Classification of Functioning, Disability and Health Core Set for osteoarthritis (Brief-ICF-OA', '2) Methods: Eligible women aged ≥60 years who had received unilateral primary TKR', 'older women with KOA']","['Elastic resistance exercise training (RET', 'postoperative RET', 'Elastic Resistance Exercise', 'CG', 'post-TKR elastic RET']","['leg LM', 'lean mass (LM) and functional outcomes', 'LM and physical capacity, respectively, and were linked to the Brief-ICF-OA', 'gait speed']","[{'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0009797', 'cui_str': 'Informed Consent Forms'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009797', 'cui_str': 'Informed Consent Forms'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",40.0,0.0549851,"At T 2 , the EG exhibited significantly greater improvements in leg LM (mean difference (MD) = 0.86 kg,  p  = 0.004) and gait speed (MD = 0.26 m/s,  p  = 0.005) compared with the CG.","[{'ForeName': 'Chun-De', 'Initials': 'CD', 'LastName': 'Liao', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University, New Taipei City 23561, Taiwan.'}, {'ForeName': 'Yen-Shuo', 'Initials': 'YS', 'LastName': 'Chiu', 'Affiliation': 'Department of Orthopedics, Shuang Ho Hospital, Taipei Medical University, New Taipei City 23561, Taiwan.'}, {'ForeName': 'Jan-Wen', 'Initials': 'JW', 'LastName': 'Ku', 'Affiliation': 'Department of Radiology, Shuang Ho Hospital, Taipei Medical University, New Taipei City 23561, Taiwan.'}, {'ForeName': 'Shih-Wei', 'Initials': 'SW', 'LastName': 'Huang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University, New Taipei City 23561, Taiwan.'}, {'ForeName': 'Tsan-Hon', 'Initials': 'TH', 'LastName': 'Liou', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University, New Taipei City 23561, Taiwan.'}]",Journal of clinical medicine,['10.3390/jcm9072194']
1463,32664552,Pain Neuroscience Education Plus Usual Care Is More Effective Than Usual Care Alone to Improve Self-Efficacy Beliefs in People with Chronic Musculoskeletal Pain: A Non-Randomized Controlled Trial.,"Self-efficacy beliefs are associated with less physical impairment and pain intensity in people with chronic pain. Interventions that build self-efficacy beliefs may foster behavioral changes among this population. A non-randomized trial has been carried out to evaluate the effectiveness of pain neuroscience education (PNE) plus usual care in modifying self-efficacy beliefs, pain intensity, pain interference and analgesics consumption in people with chronic musculoskeletal pain. Participants were allocated to an experimental (PNE plus usual care,  n =  49) and a control (usual care alone,  n =  51) group. The primary outcome was self-efficacy beliefs (Chronic Pain Self-Efficacy Scale), and the secondary outcomes were pain intensity, pain interference (Graded Chronic Pain Scale) and analgesics consumption. The participant's pain knowledge (revised Neurophysiology of Pain Questionnaire) after PNE intervention was also assessed to analyze its influence on every outcome measure. All the outcome measures were assessed at the baseline and at four-week and four-month follow-ups. PNE plus usual care was more effective than usual care alone to increase self-efficacy beliefs and decrease pain intensity and pain interference at all follow-up points. No differences between groups were found in terms of analgesics consumption. Knowledge of pain neurophysiology did not modify the effects of PNE plus usual care in any of the outcome measures. These results should be taken with caution because of the non-randomized nature of this design, the limited follow-ups and the uncertainty of the presence of clinical changes in self-efficacy for participants. Larger, methodological sound trials are needed.",2020,Knowledge of pain neurophysiology did not modify the effects of PNE plus usual care in any of the outcome measures.,"['people with chronic musculoskeletal pain', 'people with chronic pain', 'People with Chronic Musculoskeletal Pain']","['Usual Care Alone', 'pain neuroscience education (PNE) plus usual care', 'experimental (PNE plus usual care,  n =  49) and a control (usual care alone,  n =  51) group']","['pain knowledge (revised Neurophysiology of Pain Questionnaire', 'physical impairment and pain intensity', 'analgesics consumption', 'self-efficacy beliefs and decrease pain intensity and pain interference', 'pain intensity, pain interference and analgesics consumption', 'self-efficacy beliefs (Chronic Pain Self-Efficacy Scale), and the secondary outcomes were pain intensity, pain interference (Graded Chronic Pain Scale) and analgesics consumption', 'Self-Efficacy Beliefs']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0027901', 'cui_str': 'Neurophysiology'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0231171', 'cui_str': 'Physical impairment'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",,0.0923249,Knowledge of pain neurophysiology did not modify the effects of PNE plus usual care in any of the outcome measures.,"[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rondon-Ramos', 'Affiliation': 'Servicio Andaluz de Salud, Distrito de Atención Primaria Costa del Sol, U.G.C. Las Lagunas, 29650 Mijas, Málaga, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martinez-Calderon', 'Affiliation': 'Universidad de Málaga, Facultad de Ciencias de la Salud, Departamento de Fisioterapia, 29071 Málaga, Spain.'}, {'ForeName': 'Juan Luis', 'Initials': 'JL', 'LastName': 'Diaz-Cerrillo', 'Affiliation': 'Servicio Andaluz de Salud, Distrito de Atención Primaria Costa del Sol, U.G.C. La Carihuela, 29620 Torremolinos, Málaga, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Rivas-Ruiz', 'Affiliation': 'Research Unit, Agencia Sanitaria Costa del Sol, 29603 Marbella, Málaga, Spain.'}, {'ForeName': 'Gina Rocio', 'Initials': 'GR', 'LastName': 'Ariza-Hurtado', 'Affiliation': 'Servicio Andaluz de Salud, Distrito de Atención Primaria Costa del Sol, U.G.C. San Pedro de Alcántara, 29670 Marbella, Málaga, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Clavero-Cano', 'Affiliation': 'Servicio Andaluz de Salud, Distrito de Atención Primaria Costa del Sol, U.G.C. Las Albarizas, 29600 Marbella, Málaga, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Luque-Suarez', 'Affiliation': 'Universidad de Málaga, Facultad de Ciencias de la Salud, Departamento de Fisioterapia, 29071 Málaga, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9072195']
1464,32664567,Artificial Saliva in Diabetic Xerostomia (ASDIX): Double Blind Trial of Aldiamed ®  Versus Placebo.,"Xerostomia is a symptom frequently present in patients with type 1 (T1DM) and type 2 diabetes mellitus (T2DM). In the present trial, the activity of an artificial saliva (aldiamed ®  spray) in comparison to a placebo spray were used to evaluate the xerostomia and the saliva antioxidant capacity (SAT). Sixty patients of both genders with T1DM or T2DM were randomized into two groups of 30 subjects each. The experiment was a double-blind study approved by the Ethics Committee of the ""G. d'Annunzio University"" of Chieti and Pescara. Moreover, measurements of the stimulated saliva flow rate and the ultrasonography of the submandibular and parotid glands were performed at both the study time points. The results demonstrated statistically significant differences between the treatments in terms of the xerostomia average score. Specifically, the values were at baseline and after 30 days 2.9 ± 1.31 and 3.0 ± 1.44 and 1.4 ± 1.48 and 2.4 ± 0.99 for aldiamed ®  spray and the placebo, respectively. Meanwhile, no statistically significant differences were shown between the two groups for the other variables, such as the salivary flow rate, the antioxidant capacity of the saliva, and the ultrasonography of the major salivary glands.",2020,"Meanwhile, no statistically significant differences were shown between the two groups for the other variables, such as the salivary flow rate, the antioxidant capacity of the saliva, and the ultrasonography of the major salivary glands.","['Diabetic Xerostomia (ASDIX', 'patients with type 1 (T1DM) and type 2 diabetes mellitus (T2DM', 'Sixty patients of both genders with T1DM or T2DM']",['Aldiamed ®  Versus Placebo'],"['stimulated saliva flow rate', 'xerostomia and the saliva antioxidant capacity (SAT', 'salivary flow rate, the antioxidant capacity of the saliva, and the ultrasonography of the major salivary glands', 'xerostomia average score', 'Xerostomia']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0429177', 'cui_str': 'Salivary flow rate'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0930553', 'cui_str': 'Major salivary gland structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.205281,"Meanwhile, no statistically significant differences were shown between the two groups for the other variables, such as the salivary flow rate, the antioxidant capacity of the saliva, and the ultrasonography of the major salivary glands.","[{'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Sinjari', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Feragalli', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Cornelli', 'Affiliation': 'Stritch School of Medicine, Loyola University Chicago, Maywood, IL 60611, USA.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Belcaro', 'Affiliation': 'Irwin Labs, University of Chieti, 65010 Spoltore, Italy.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Vitacolonna', 'Affiliation': 'Department of Medicine and Aging Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Manlio', 'Initials': 'M', 'LastName': 'Santilli', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Imena', 'Initials': 'I', 'LastName': 'Rexhepi', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Gianmaria', 'Initials': 'G', 'LastName': ""D'Addazio"", 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Zuccari', 'Affiliation': 'Marchegiani Analysis Laboratory, 65122 Pescara, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Caputi', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}]",Journal of clinical medicine,['10.3390/jcm9072196']
1465,32669717,Investigation of the safety and feasibility of AAV1/SERCA2a gene transfer in patients with chronic heart failure supported with a left ventricular assist device - the SERCA-LVAD TRIAL.,"The SERCA-LVAD trial was a phase 2a trial assessing the safety and feasibility of delivering an adeno-associated vector 1 carrying the cardiac isoform of the sarcoplasmic reticulum calcium ATPase (AAV1/SERCA2a) to adult chronic heart failure patients implanted with a left ventricular assist device. The SERCA-LVAD trial was one of a program of AAV1/SERCA2a cardiac gene therapy trials including CUPID1, CUPID 2 and AGENT trials. Enroled subjects were randomised to receive a single intracoronary infusion of 1 × 10 13  DNase-resistant AAV1/SERCA2a particles or a placebo solution in a double-blinded design, stratified by presence of neutralising antibodies to AAV. Elective endomyocardial biopsy was performed at 6 months unless the subject had undergone cardiac transplantation, with myocardial samples assessed for the presence of exogenous viral DNA from the treatment vector. Safety assessments including ELISPOT were serially performed. Although designed as a 24 subject trial, recruitment was stopped after five subjects had been randomised and received infusion due to the neutral result from the CUPID 2 trial. Here we describe the results from the 5 patients at 3 years follow up, which confirmed that viral DNA was delivered to the failing human heart in 2 patients receiving gene therapy with vector detectable at follow up endomyocardial biopsy or cardiac transplantation. Absolute levels of detectable transgene DNA were low, and no functional benefit was observed. There were no safety concerns in this small cohort. This trial identified some of the challenges of performing gene therapy trials in this LVAD patient cohort which may help guide future trial design.",2020,"Absolute levels of detectable transgene DNA were low, and no functional benefit was observed.","['adult chronic heart failure patients implanted with a left ventricular assist device', 'patients with chronic heart failure supported with a left ventricular assist device - the SERCA-LVAD TRIAL']","['Elective endomyocardial biopsy', 'sarcoplasmic reticulum calcium ATPase (AAV1/SERCA2a', 'single intracoronary infusion of 1\u2009×\u200910 13  DNase-resistant AAV1/SERCA2a particles or a placebo solution', 'AAV1/SERCA2a gene transfer', 'failing human heart in 2 patients receiving gene therapy with vector detectable at follow up endomyocardial biopsy or cardiac transplantation']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0189785', 'cui_str': 'Endomyocardial biopsy'}, {'cui': 'C0916181', 'cui_str': 'Calcium-Transporting ATPases, Sarcoplasmic Reticulum'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0595454', 'cui_str': 'Intracoronary route'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0011519', 'cui_str': 'Deoxyribonuclease I'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}]",[],,0.220029,"Absolute levels of detectable transgene DNA were low, and no functional benefit was observed.","[{'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Lyon', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK. a.lyon@imperial.ac.uk.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Babalis', 'Affiliation': 'Imperial Clinical Trials Unit (ICTU), School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Morley-Smith', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hedger', 'Affiliation': 'NIHR Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield Hospitals NHS Trust, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Suarez Barrientos', 'Affiliation': 'NIHR Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield Hospitals NHS Trust, London, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Foldes', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'L S', 'Initials': 'LS', 'LastName': 'Couch', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Chowdhury', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Tzortzis', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Peters', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Rog-Zielinska', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'H-Y', 'Initials': 'HY', 'LastName': 'Yang', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Welch', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'C T', 'Initials': 'CT', 'LastName': 'Bowles', 'Affiliation': 'NIHR Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield Hospitals NHS Trust, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rahman Haley', 'Affiliation': 'NIHR Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield Hospitals NHS Trust, London, UK.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Bell', 'Affiliation': 'Department of Histopathology, Royal Brompton and Harefield Hospitals NHS Trust, Freiburg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rice', 'Affiliation': 'Department of Histopathology, Royal Brompton and Harefield Hospitals NHS Trust, Freiburg, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sasikaran', 'Affiliation': 'Imperial Clinical Trials Unit (ICTU), School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Johnson', 'Affiliation': 'Imperial Clinical Trials Unit (ICTU), School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Falaschetti', 'Affiliation': 'Imperial Clinical Trials Unit (ICTU), School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Parameshwar', 'Affiliation': 'Royal Papworth Hospital NHS Trust, Cambridge, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lewis', 'Affiliation': 'Royal Papworth Hospital NHS Trust, Cambridge, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tsui', 'Affiliation': 'Royal Papworth Hospital NHS Trust, Cambridge, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Simon', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pepper', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Rudy', 'Affiliation': 'Celladon Corporation, San Diego, CA, USA.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Zsebo', 'Affiliation': 'Celladon Corporation, San Diego, CA, USA.'}, {'ForeName': 'K T', 'Initials': 'KT', 'LastName': 'Macleod', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Terracciano', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Hajjar', 'Affiliation': 'Phospholamban Foundation, Amsterdam, Netherlands.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Banner', 'Affiliation': 'NIHR Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield Hospitals NHS Trust, London, UK.'}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Harding', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}]",Gene therapy,['10.1038/s41434-020-0171-7']
1466,32671687,Influence of Fasting Glucose Levels on Achieving Glycemic Target in Individuals with Type 2 Diabetes: a Post Hoc Analysis.,"INTRODUCTION


FPG GOAL was a 24-week, open-label, treat-to-target randomized controlled trial which demonstrated that the optimal self-monitored fasting blood glucose (SM-FBG) target for most Chinese individuals with type 2 diabetes (T2D) using insulin glargine 100 IU/mL was 3.9-6.1 mmol/L. Individuals who achieved lower fasting plasma glucose (FPG) levels might achieve the target HbA1c of < 7% without increasing the risk of hypoglycemia.
METHODS


For this post hoc analysis, individuals were redivided into three groups based on their actual laboratory FPG levels at 24 weeks: level 1, ≤ 5.6 mmol/L; level 2, > 5.6 to ≤ 6.1 mmol/L; and level 3, > 6.1 to ≤ 7.0 mmol/L.
RESULTS


At week 24, 863 individuals with diabetes had available FPG data and 179, 122, and 179 individuals achieved FPG levels 1, 2, and 3, respectively. The proportion of individuals with HbA1c < 7% or HbA1c < 7% without hypoglycemia (≤ 3.9 or ≤ 3.0 mmol/L) was significantly higher in FPG levels 1 (p < 0.01) and 2 (p < 0.05) than in level 3. The least squares mean changes from baseline in HbA1c (- 1.77% and - 1.66% vs - 1.34%; both p < 0.001) and 2-h postprandial glucose (- 3.88 mmol/L and - 3.98 mmol/L vs - 3.22 mmol/L; both p < 0.05) were also significantly higher in FPG levels 1 and 2 compared with level 3. Linear regression analysis showed a moderate relationship between FPG and HbA1c levels at 24 weeks (r = 0.449).
CONCLUSIONS


Chinese individuals with T2D who achieved lower FPG levels with insulin glargine 100 IU/mL were more likely to achieve the recommended target HbA1c of < 7% compared with those with higher FPG levels. ClinicalTrials.gov identifier NCT02545842.",2020,mL were more likely to achieve the recommended target HbA1c of < 7% compared with those with higher FPG levels.,"['Individuals with Type\xa02 Diabetes', '863 individuals with diabetes had available FPG data and 179, 122, and 179 individuals achieved', 'Chinese individuals with type\xa02 diabetes (T2D) using']","['insulin glargine', 'Fasting Glucose Levels']","['FPG levels', 'actual laboratory FPG levels', 'hypoglycemia', '2-h postprandial glucose', 'fasting plasma glucose (FPG) levels', 'FPG and HbA1c levels']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}]","[{'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",863.0,0.0347012,mL were more likely to achieve the recommended target HbA1c of < 7% compared with those with higher FPG levels.,"[{'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Nanjing First Hospital, Nanjing, China.'}, {'ForeName': 'Minxiang', 'Initials': 'M', 'LastName': 'Lei', 'Affiliation': 'Xiangya Hospital Central South University, Changsha, China.'}, {'ForeName': 'Yunguang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Sanofi Investment Co., Ltd., Shanghai, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Sanofi Investment Co., Ltd., Shanghai, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Cui', 'Affiliation': 'Sanofi Investment Co., Ltd., Shanghai, China.'}, {'ForeName': 'Wenying', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China. ywying_1010@163.com.'}]",Advances in therapy,['10.1007/s12325-020-01410-1']
1467,32671846,"Similar pharmacokinetics of three dosing regimens comprising two oral delayed-release mesalamine formulations in healthy adult volunteers: Randomised, open-label, parallel-group study.","AIMS


Mesalamine is the first-line therapy for treating mild-to-moderate ulcerative colitis. Multiple mesalamine formulations are available, with similar safety and efficacy profiles. Mesalamine is commonly administered as divided dosing, although once-daily dosing may provide benefits for patients. We evaluated the pharmacokinetics of three dosing regimens of two oral delayed-release mesalamine formulations in healthy adult volunteers.
METHODS


A randomised, open-label, parallel-group study of mesalamine pharmacokinetics following Lialda 2 × 1.2 g once daily (QD) (dose A), Asacol 6 × 400 mg QD (dose B), or Asacol 2 × 400 mg three times daily (TID) (dose C) over 7 days. Assessments included 5-aminosalicylic acid (5-ASA) and N-acetyl 5-aminosalicylic acid (N-Ac-5-ASA, primary metabolite) pharmacokinetics (A e  (%), AUC 0-24  and C max  ), safety and tolerability.
RESULTS


All enrolled volunteers (n = 37) completed the study. Steady state was achieved for all treatments by day 4. Ratios (95% CI) of means for steady-state AUC 0-24  (dose A vs B 90.3% [39.8, 204.8], dose A vs C 123.5% [55.3, 275.7], dose B vs C 136.8% [61.3, 305.5]) and C max  (dose A vs B 106.0% [46.4, 242.2], dose A vs C 133.0% [59.1, 299.0], dose B vs C 125.5% [55.8, 282.1]) were similar for all 5-ASA treatments. Mean urinary excretion of 5-ASA plus N-Ac-5-ASA was comparable between treatments (dose A 21.3%, dose B 20.2%, dose C 17.9%). All treatment regimens were well tolerated; no safety issues were observed.
CONCLUSIONS


Plasma and urine pharmacokinetics for Asacol TID, Asacol QD, and Lialda QD are similar, suggesting similar daily systemic exposures can be obtained with either TID or QD dosing. NCT00751699.",2020,Mean urinary excretion of 5-ASA plus N-Ac-5-ASA was comparable between treatments [Dose A: 21.3%; Dose B: 20.2%; Dose C: 17.9%].,"['All enrolled volunteers [N = 37] completed the study', 'Healthy Adult Volunteers', 'healthy adult volunteers']","['Asacol 6× 400 mg QD', 'Asacol 2× 400 mg three-times-daily [TID', 'mesalamine pharmacokinetics following Lialda 2× 1.2 g once-daily [QD', 'oral delayed-release mesalamine formulations', 'Mesalamine', 'Two Oral Delayed-Release Mesalamine Formulations']","['safety and tolerability', 'Mean urinary excretion of 5-ASA plus N-Ac-5-ASA', 'Steady-state', '5-aminosalicylic acid [5-ASA] and N-acetyl 5-aminosalicylic acid [N-Ac-5-ASA; primary metabolite] pharmacokinetics ', 'tolerated; no safety issues']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0678172', 'cui_str': 'Asacol'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0127615', 'cui_str': 'mesalamine'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1873792', 'cui_str': 'Lialda'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0127615', 'cui_str': 'mesalamine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004475', 'cui_str': 'Azacitidine'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0067638', 'cui_str': 'N-acetyl-5-aminosalicylic acid'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",,0.146909,Mean urinary excretion of 5-ASA plus N-Ac-5-ASA was comparable between treatments [Dose A: 21.3%; Dose B: 20.2%; Dose C: 17.9%].,"[{'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Vande Casteele', 'Affiliation': 'University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Abhijeet', 'Initials': 'A', 'LastName': 'Jakate', 'Affiliation': 'Allergan plc, Jersey City, NJ, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'McNamee', 'Affiliation': 'Allergan Biologics Ltd, Liverpool, UK.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'University of California, San Diego, La Jolla, CA, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.14479']
1468,32672806,Effectiveness of a Multimedia Educational Intervention to Improve Understanding of the Risks and Benefits of Palliative Chemotherapy in Patients With Advanced Cancer: A Randomized Clinical Trial.,"Importance


Despite requirements of informed consent, patients with advanced cancer often receive palliative chemotherapy (PC) without understanding that the likelihood of cure is remote.
Objective


To determine whether a PC educational video and booklet at treatment initiation could improve patients' understanding of its benefits and risks.
Interventions


Regimen-specific PC videos and booklets presenting information about logistics, potential benefits, life expectancy (optional), adverse effects, and alternatives. Videos featured authentic patients sharing diverse experiences. After receiving treatment recommendations, research assistants distributed materials to patients for independent review.
Design, Setting, and Participants


Multicenter randomized clinical trial of patients with advanced colorectal or pancreatic cancer starting first-line or second-line PC in 5 US cancer centers with enrollment from June 2015 to September 2017 and follow-up to December 2019.
Main Outcomes and Measures


The primary outcome was accurate expectations of chemotherapy benefits at 3 months, defined as responding ""not at all likely"" to ""What is your understanding of how likely the chemotherapy is to cure your cancer?"" (from the Cancer Care Outcomes Research and Surveillance study). Secondary outcomes included understanding of adverse effects, decisional conflict (SURE test), regret (Decisional Regret Scale), and distress (Functional Assessment of Cancer Therapy-General emotional well-being subscale).
Results


Among 186 patients with advanced colorectal or pancreatic cancer who were starting first-line or second-line PC (94 randomized to usual care, 92 to intervention; mean [SD] age, 59.3 [12.6] [range, 28-86] years; 107 [58%] male; 118 [63.4%] colorectal and 68 [36.6%] pancreatic cancer), most patients wanted ""a lot"" of information or ""as much information as possible"" about adverse effects (149, 80.1%), likelihood of cure (148, 79.6%), and prognosis (148, 79.6%). Among the intervention arm, 59 (78%) reviewed the booklet and 30 (40%) reviewed the video within 2 weeks. The primary outcome did not differ between intervention and control arms (52.6%; 95% CI, 40.3%-65.0%; vs 55.5%; 95% CI, 45.1%-66.0%). Accurate adverse effect understanding was more common among intervention than control patients (56.0%; 95% CI, 44.3%-67.7%; vs 40.2%; 95% CI, 29.5%-50.9%; P = .05), although this did not meet the threshold for statistical significance. The intervention did not increase distress, despite frank prognostic information. Other secondary outcomes were similar.
Conclusions and Relevance


Provision of an educational video and booklet did not alter patients' expectation of cure from PC. Alternative delivery strategies, such as integration with nurse teaching, could be explored in future studies.
Trial Registration


ClinicalTrials.gov Identifier: NCT02282722.",2020,"Accurate adverse effect understanding was more common among intervention than control patients (56.0%; 95% CI, 44.3%-67.7%; vs 40.2%; 95% CI, 29.5%-50.9%; P = .05), although this did not meet the threshold for statistical significance.","['Patients With Advanced Cancer', 'patients with advanced cancer often receive', 'patients with advanced colorectal or pancreatic cancer starting first-line or second-line PC in 5 US cancer centers with enrollment from June 2015 to September 2017 and follow-up to December 2019', '186 patients with advanced colorectal or pancreatic cancer who were starting first-line or second-line PC (94 randomized to usual care, 92 to intervention; mean [SD] age, 59.3 [12.6] [range, 28-86] years; 107 [58%] male; 118 [63.4%] colorectal and 68']","['Palliative Chemotherapy', 'palliative chemotherapy (PC', 'PC educational video and booklet', 'Multimedia Educational Intervention']","['likelihood of cure', 'understanding of adverse effects, decisional conflict (SURE test), regret (Decisional Regret Scale), and distress (Functional Assessment of Cancer Therapy-General emotional well-being subscale', 'accurate expectations of chemotherapy benefits', 'distress, despite frank prognostic information', 'pancreatic cancer']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517545', 'cui_str': '12.6'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517542', 'cui_str': '118'}]","[{'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0398650', 'cui_str': 'Idiopathic thrombocytopenic purpura'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}]",186.0,0.171388,"Accurate adverse effect understanding was more common among intervention than control patients (56.0%; 95% CI, 44.3%-67.7%; vs 40.2%; 95% CI, 29.5%-50.9%; P = .05), although this did not meet the threshold for statistical significance.","[{'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Enzinger', 'Affiliation': 'Division of Population Sciences, Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Uno', 'Affiliation': 'Division of Population Sciences, Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'McCleary', 'Affiliation': 'Division of Gastrointestinal Oncology, Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Frank', 'Affiliation': ""Susan F. Smith Center for Women's Cancers, Dana-Farber/Partners CancerCare, Boston, Massachusetts.""}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Sanoff', 'Affiliation': 'Division of Medical Oncology, University of North Carolina Lineberger Cancer Center, Chapel Hill.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Van Loon', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, University of California, San Francisco.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Matin', 'Affiliation': 'Division of Medical Oncology, Virginia Commonwealth University, Richmond.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bullock', 'Affiliation': 'Division of Medical Oncology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Cronin', 'Affiliation': 'Division of Population Sciences, Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Cibotti', 'Affiliation': 'Department of Nursing, Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Bagley', 'Affiliation': 'Department of Nursing, Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Schrag', 'Affiliation': 'Division of Population Sciences, Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}]",JAMA oncology,['10.1001/jamaoncol.2020.1921']
1469,32668483,Platelet Inhibition with Ticagrelor versus Clopidogrel in Diabetic Patients after Percutaneous Coronary Intervention for Chronic Coronary Syndromes.,"BACKGROUND


Clopidogrel is currently the only P2Y 12  inhibitor with class I recommendation in patients after percutaneous coronary intervention (PCI) for chronic coronary syndromes (CCS). Diabetic patients have reduced therapeutic response to clopidogrel.
PURPOSE


This study assessed the antiplatelet effect of ticagrelor versus clopidogrel in diabetic patients after recent PCI for CCS.
METHODS


Eligible patients were randomly assigned to receive ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily, in addition to aspirin 100 mg once daily for 15 days. P2Y 12  reaction unit (PRU) and percent inhibition were measured by VerifyNow P2Y 12  assay. High on-treatment platelet reactivity (HOPR) was defined as PRU > 208. Bleeding was assessed by the Platelet Inhibition and Patient Outcomes criteria. Cardiac ischemic events were evaluated as adverse events.
RESULTS


The baseline characteristics of the patients ( n  = 39) were well balanced between the two groups. Both before and 2 to 4 hours after the final study dose on day 15, PRU was lower (41.3 ± 35.8 vs. 192.6 ± 49.5,  p  < 0.001; 36.6 ± 25.8 vs. 187.6 ± 70.9,  p  < 0.001), percent inhibition was higher (83.0% [70.5%, 96.0%] vs. 16.0% [0%, 25.0%],  p  < 0.001; 85.0% [76.0%, 96.5%] vs. 25.0% [0%, 39.0%],  p  < 0.001), and HOPR occurred less frequently (0% [0/20] vs. 26.3% [5/19],  p  = 0.020; 0% [0/20] vs. 31.6% [6/19],  p  = 0.008) in the ticagrelor group ( n  = 20) compared with the clopidogrel group ( n  = 19). No major or minor bleeding, or serious adverse events occurred in both groups.
CONCLUSION


Ticagrelor achieved greater peak and trough platelet inhibition than did clopidogrel in diabetic patients after recent PCI for CCS, which suggests the potential use of ticagrelor in this clinical setting.",2020,"No major or minor bleeding, or serious adverse events occurred in both groups.
","['chronic coronary syndromes (CCS', 'Diabetic Patients after Percutaneous Coronary Intervention for Chronic Coronary Syndromes', 'Diabetic patients', 'diabetic patients after recent PCI for CCS', 'diabetic patients', 'Eligible patients']","['Ticagrelor', 'percutaneous coronary intervention (PCI', 'Clopidogrel', 'ticagrelor 90\u2009mg twice daily or clopidogrel 75\u2009mg once daily, in addition to aspirin', 'clopidogrel', 'ticagrelor']","['percent inhibition', 'Bleeding', 'No major or minor bleeding, or serious adverse events', 'Cardiac ischemic events', 'peak and trough platelet inhibition', 'P2Y 12  reaction unit (PRU) and percent inhibition', 'HOPR', 'Platelet Inhibition']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332185', 'cui_str': 'Recent'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C3163568', 'cui_str': 'Ticagrelor 90 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C1124675', 'cui_str': 'clopidogrel 75 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C1628982', 'cui_str': '% inhib'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]",,0.0644685,"No major or minor bleeding, or serious adverse events occurred in both groups.
","[{'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Tian', 'Affiliation': 'Department of Cardiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Medical Research and Biometrics Center, Fu-Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Laboratory Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shuyang', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Thrombosis and haemostasis,['10.1055/s-0040-1713375']
1470,32687836,Failure of tDCS to modulate motor excitability and speech motor learning.,"Transcranial direct current stimulation (tDCS) modulates cortical excitability in a polarity-specific way and, when used in combination with a behavioural task, it can alter performance. TDCS has the potential, therefore, for use as an adjunct to therapies designed to treat disorders affecting speech, including, but not limited to acquired aphasias and developmental stuttering. For this reason, it is important to conduct studies evaluating its effectiveness and the parameters optimal for stimulation. Here, we aimed to evaluate the effects of bi-hemispheric tDCS over speech motor cortex on performance of a complex speech motor learning task, namely the repetition of tongue twisters. A previous study in older participants showed that tDCS could modulate performance on a similar task. To further understand the effects of tDCS, we also measured the excitability of the speech motor cortex before and after stimulation. Three groups of 20 healthy young controls received: (i) anodal tDCS to the left IFG/LipM1 and cathodal tDCS to the right hemisphere homologue; or (ii) cathodal tDCS over the left and anodal over the right; or (iii) sham stimulation. Participants heard and repeated novel tongue twisters and matched simple sentences before, during and 10 min after the stimulation. One mA tDCS was delivered concurrent with task performance for 13 min. Motor excitability was measured using transcranial magnetic stimulation to elicit motor-evoked potentials in the lip before and immediately after tDCS. The study was double-blind, randomized, and sham-controlled; the design and analysis were pre-registered. Performance on the task improved from baseline to after stimulation but was not significantly modulated by tDCS. Similarly, a small decrease in motor excitability was seen in all three stimulation groups but did not differ among them and was unrelated to task performance. Bayesian analyses provide substantial evidence in support of the null hypotheses in both cases, namely that tongue twister performance and motor excitability were not affected by tDCS. We discuss our findings in the context of the previous positive results for a similar task. We conclude that tDCS may be most effective when brain function is sub-optimal due to age-related declines or pathology. Further study is required to determine why tDCS failed to modulate excitability in the speech motor cortex in the expected ways.",2020,"Similarly, a small decrease in motor excitability was seen in all three stimulation groups but did not differ among them and were unrelated to task performance.","['older participants', '20 healthy young controls received: (i']","['bi-hemispheric tDCS', 'Transcranial direct current stimulation (tDCS', 'TDCS', 'tDCS', 'anodal tDCS to the left IFG/LipM1 and cathodal tDCS to the right hemisphere homologue; or (ii) cathodal tDCS over the left and anodal over the right; or (iii) sham stimulation']","['tongue twister performance and motor excitability', 'motor excitability', 'Motor excitability']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205139', 'cui_str': 'Hemispheric'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C0546911', 'cui_str': 'To the right'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0335670', 'cui_str': 'Twister'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}]",20.0,0.046913,"Similarly, a small decrease in motor excitability was seen in all three stimulation groups but did not differ among them and were unrelated to task performance.","[{'ForeName': 'Charlotte E E', 'Initials': 'CEE', 'LastName': 'Wiltshire', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, Department of Experimental Psychology, Radcliffe Observatory Quarter, University of Oxford, OX2 6GG, UK. Electronic address: charlotte.wiltshire@psy.ox.ac.uk.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Watkins', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, Department of Experimental Psychology, Radcliffe Observatory Quarter, University of Oxford, OX2 6GG, UK. Electronic address: kate.watkins@psy.ox.ac.uk.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107568']
1471,32675595,HIPEC in advanced epithelial ovarian cancer: why is there controversy?,"PURPOSE OF REVIEW


The randomized OVHIPEC study provided further evidence that adding heated intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery significantly improved recurrence-free and overall survival in stage III epithelial ovarian cancer (EOC) patients, who were ineligible for primary cytoreductive surgery due to extensive intraperitoneal disease. Because opinions have been divided as to whether HIPEC is now a new standard of care for advanced EOC, the pros and cons of this approach are examined. A comparison with the ongoing discussion about the role of intraperitoneal chemotherapy is made.
RECENT FINDINGS


For both techniques, experience is crucial and a learning curve essential. Compared with intraperitoneal chemotherapy, intraoperative application of HIPEC provides superior distribution through the peritoneal cavity. HIPEC, as given in OVHIPEC, did not significantly increase adverse events, had no negative effect on quality of life and was cost-effective.
SUMMARY


Despite the ongoing debate about HIPEC, an important first step in attempting to demonstrate the efficacy of HIPEC in the first-line setting has been made with OVHIPEC. Critics have been of value to optimize future trials with HIPEC in patients with EOC.",2020,"HIPEC, as given in OVHIPEC, did not significantly increase adverse events, had no negative effect on quality of life and was cost-effective.
","['advanced epithelial ovarian cancer', 'patients with EOC', 'stage III epithelial ovarian cancer (EOC) patients, who were ineligible for primary cytoreductive surgery due to extensive intraperitoneal disease']","['intraperitoneal chemotherapy, intraoperative application of HIPEC', 'HIPEC', 'heated intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery', 'intraperitoneal chemotherapy']","['quality of life and was cost-effective', 'recurrence-free and overall survival', 'adverse events']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0461488,"HIPEC, as given in OVHIPEC, did not significantly increase adverse events, had no negative effect on quality of life and was cost-effective.
","[{'ForeName': 'Jan B', 'Initials': 'JB', 'LastName': 'Vermorken', 'Affiliation': 'Department of Medical Oncology.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'van Dam', 'Affiliation': 'Department of Gynecologic Oncology, Antwerp University Hospital, Edegem.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Brand', 'Affiliation': 'Department of Gynecological Oncology, Westmead Hospital.'}]",Current opinion in oncology,['10.1097/CCO.0000000000000659']
1472,32678530,Dexamethasone in Hospitalized Patients with Covid-19 - Preliminary Report.,"BACKGROUND


Coronavirus disease 2019 (Covid-19) is associated with diffuse lung damage. Glucocorticoids may modulate inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death.
METHODS


In this controlled, open-label trial comparing a range of possible treatments in patients who were hospitalized with Covid-19, we randomly assigned patients to receive oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days or to receive usual care alone. The primary outcome was 28-day mortality. Here, we report the preliminary results of this comparison.
RESULTS


A total of 2104 patients were assigned to receive dexamethasone and 4321 to receive usual care. Overall, 482 patients (22.9%) in the dexamethasone group and 1110 patients (25.7%) in the usual care group died within 28 days after randomization (age-adjusted rate ratio, 0.83; 95% confidence interval [CI], 0.75 to 0.93; P<0.001). The proportional and absolute between-group differences in mortality varied considerably according to the level of respiratory support that the patients were receiving at the time of randomization. In the dexamethasone group, the incidence of death was lower than that in the usual care group among patients receiving invasive mechanical ventilation (29.3% vs. 41.4%; rate ratio, 0.64; 95% CI, 0.51 to 0.81) and among those receiving oxygen without invasive mechanical ventilation (23.3% vs. 26.2%; rate ratio, 0.82; 95% CI, 0.72 to 0.94) but not among those who were receiving no respiratory support at randomization (17.8% vs. 14.0%; rate ratio, 1.19; 95% CI, 0.91 to 1.55).
CONCLUSIONS


In patients hospitalized with Covid-19, the use of dexamethasone resulted in lower 28-day mortality among those who were receiving either invasive mechanical ventilation or oxygen alone at randomization but not among those receiving no respiratory support. (Funded by the Medical Research Council and National Institute for Health Research and others; RECOVERY ClinicalTrials.gov number, NCT04381936; ISRCTN number, 50189673.).",2020,"In the dexamethasone group, the incidence of death was lower than that in the usual care group among patients receiving invasive mechanical ventilation (29.3% vs. 41.4%; rate ratio, 0.64; 95% CI, 0.51 to 0.81) and among those receiving oxygen without invasive mechanical ventilation (23.3% vs. 26.2%; rate ratio, 0.82; 95% CI, 0.72 to 0.94) but not among those who were receiving no respiratory support at randomization (17.8% vs. 14.0%; rate ratio, 1.19; 95% CI, 0.91 to 1.55).
","['Hospitalized Patients with Covid-19 - Preliminary Report', '2104 patients', 'patients who were hospitalized with Covid-19']","['usual care alone', 'dexamethasone and 4321 to receive usual care', 'dexamethasone', 'Glucocorticoids', 'invasive mechanical ventilation or oxygen alone', 'oral or intravenous dexamethasone', 'Dexamethasone']","['incidence of death', 'mortality', '28-day mortality', 'receiving oxygen without invasive mechanical ventilation']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}]",2104.0,0.237066,"In the dexamethasone group, the incidence of death was lower than that in the usual care group among patients receiving invasive mechanical ventilation (29.3% vs. 41.4%; rate ratio, 0.64; 95% CI, 0.51 to 0.81) and among those receiving oxygen without invasive mechanical ventilation (23.3% vs. 26.2%; rate ratio, 0.82; 95% CI, 0.72 to 0.94) but not among those who were receiving no respiratory support at randomization (17.8% vs. 14.0%; rate ratio, 1.19; 95% CI, 0.91 to 1.55).
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Horby', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Wei Shen', 'Initials': 'WS', 'LastName': 'Lim', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Emberson', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Mafham', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Bell', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Linsell', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Staplin', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Brightling', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ustianowski', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Einas', 'Initials': 'E', 'LastName': 'Elmahi', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Prudon', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Felton', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chadwick', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Kanchan', 'Initials': 'K', 'LastName': 'Rege', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Fegan', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Lucy C', 'Initials': 'LC', 'LastName': 'Chappell', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Saul N', 'Initials': 'SN', 'LastName': 'Faust', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Jeffery', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Montgomery', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Rowan', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Juszczak', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'J Kenneth', 'Initials': 'JK', 'LastName': 'Baillie', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Haynes', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Landray', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}]",The New England journal of medicine,['10.1056/NEJMoa2021436']
1473,32666396,Modified Encircling Scleral Buckle Technique Without Subretinal Fluid Drainage or Retinopexy.,"INTRODUCTION


Scleral buckling (SB) tends to be more challenging and time-consuming for compared to the pars plana vitrectomy for repairing rhegmatogenous retinal detachments (RRDs). This study characterizes a novel and simplified technique for SB.
METHODS


In this single-masked randomized interventional study, patients with RRDs who were eligible for SB were randomly assigned to either the standard (S) or modified (M) technique of SB. In the modified approach, neither intraoperative break localization nor cryopexy or subretinal fluid drainage was done. A large tire (276/279) was placed where preoperative retinal breaks had been localized with a 240 encircling band placed for support of the remaining retina. Patients were followed for 12 months and the primary outcomes were differences between the surgical groups in operative time, anatomical success, visual acuity, and complication rate.
RESULTS


Thirty-six eyes were included in the study (18 in each arm). There were no differences in baseline patient demographics or characteristics including gender, age, lens and macular status, preoperative vision, and symptom duration. The mean length of surgery was 72.2 ± 13.2 and 56.2 ± 9.5 min in groups S and M, respectively (P = 0.001). Complete retinal reattachment at the end of month 12 after single surgery was 80.6% overall; 77.8% (14/18) in group S and 83.3% (15/18) in group M (P > 0.999). After 12 months, both groups achieved similar final best-corrected visual acuity (BCVA): 0.26 ± 0.23 and 0.23 ± 0.17 logMAR in groups S and M, respectively (P = 0.231). Controlling for preoperative BCVA on ANCOVA testing, there were no significant differences in visual improvement between the two groups [F (1,26) = 0.02, P = 0.966 (95% CI) - 0.128 to 0.123)]. Scleral perforation (2:1), vitreous hemorrhage (3:2), and transient rise of intraocular pressure (3:4) all occurred at a low and similar rate between the two groups (S:M).
CONCLUSION


Modified SB technique was non-inferior compared to the standard approach for anatomical and visual outcomes. Shortening surgical time while maintaining low complication rates makes this an appropriate approach to SB, especially for vitreoretinal surgery trainees.",2020,"Shortening surgical time while maintaining low complication rates makes this an appropriate approach to SB, especially for vitreoretinal surgery trainees.","['Thirty-six eyes were included in the study (18 in each arm', 'patients with RRDs who were eligible for SB']","['pars plana vitrectomy', 'standard (S) or modified (M) technique of SB', 'Scleral buckling (SB', 'Modified Encircling Scleral Buckle Technique Without Subretinal Fluid Drainage or Retinopexy', 'Modified SB technique']","['Scleral perforation (2:1), vitreous hemorrhage (3:2), and transient rise of intraocular pressure', 'similar final best-corrected visual acuity (BCVA', 'visual improvement', 'Complete retinal reattachment', 'mean length of surgery', 'baseline patient demographics or characteristics including gender, age, lens and macular status, preoperative vision, and symptom duration', 'operative time, anatomical success, visual acuity, and complication rate']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment'}, {'cui': 'C0036411', 'cui_str': 'Scleral buckling'}]","[{'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0036411', 'cui_str': 'Scleral buckling'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1868761', 'cui_str': 'Retinopexy'}]","[{'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0042909', 'cui_str': 'Vitreous hemorrhage'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0185042', 'cui_str': 'Reattachment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",36.0,0.258528,"Shortening surgical time while maintaining low complication rates makes this an appropriate approach to SB, especially for vitreoretinal surgery trainees.","[{'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Mafi', 'Affiliation': 'Department of Ophthalmology, Farabi Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Mirghorbani', 'Affiliation': 'Department of Ophthalmology, Farabi Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Ghahvehchian', 'Affiliation': 'Department of Ophthalmology, Farabi Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'S Saeed', 'Initials': 'SS', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Ophthalmology, Farabi Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Riazi-Esfahani', 'Affiliation': 'Department of Ophthalmology, Farabi Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Khalili Pour', 'Affiliation': 'Department of Ophthalmology, Farabi Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Mahmoudi', 'Affiliation': 'Department of Ophthalmology, Farabi Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Khojasteh', 'Affiliation': 'Department of Ophthalmology, Farabi Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran. khojaste_hasan@yahoo.com.'}, {'ForeName': 'Bobeck S', 'Initials': 'BS', 'LastName': 'Modjtahedi', 'Affiliation': 'Department of Ophthalmology, Southern California Permanente Medical Group, Baldwin Park, CA, USA.'}]",Ophthalmology and therapy,['10.1007/s40123-020-00279-1']
1474,32663139,Effects of a Novel Contextual Just-In-Time Mobile App Intervention (LowSalt4Life) on Sodium Intake in Adults With Hypertension: Pilot Randomized Controlled Trial.,"BACKGROUND


High dietary sodium intake is a significant public health problem in the United States. High sodium consumption is associated with high blood pressure and high risk of cardiovascular disease.
OBJECTIVE


The aim of this study was to evaluate the effect of a just-in-time adaptive mobile app intervention, namely, LowSalt4Life, on reducing sodium intake in adults with hypertension.
METHODS


In this study, 50 participants aged ≥18 years who were under treatment for hypertension were randomized (1:1, stratified by gender) into 2 groups, namely, the App group (LowSalt4Life intervention) and the No App group (usual dietary advice) in a single-center, prospective, open-label randomized controlled trial for 8 weeks. The primary endpoint was the change in the 24-hour urinary sodium excretion estimated from spot urine by using the Kawasaki equation, which was analyzed using unpaired two-sided t tests. Secondary outcomes included the change in the sodium intake measured by the food frequency questionnaire (FFQ), the 24-hour urinary sodium excretion, blood pressure levels, and the self-reported confidence in following a low-sodium diet.
RESULTS


From baseline to week 8, there was a significant reduction in the Kawasaki-estimated 24-hour urinary sodium excretion calculated from spot urine in the App group compared to that in the No App group (-462 [SD 1220] mg vs 381 [SD 1460] mg, respectively; P=.03). The change in the 24-hour urinary sodium excretion was -637 (SD 1524) mg in the App group and -322 (SD 1485) mg in the No App group (P=.47). The changes in the estimated sodium intake as measured by 24-hour dietary recall and by FFQ in the App group were -1537 (SD 2693) mg and -1553 (SD 1764) mg while those in the No App group were -233 (SD 2150) mg and -515 (SD 1081) mg, respectively (P=.07 and P=.01, respectively). The systolic blood pressure change from baseline to week 8 in the App group was -7.5 mmHg while that in the No App group was -0.7 mmHg (P=.12), but the self-confidence in following a low-sodium diet was not significantly different between the 2 groups.
CONCLUSIONS


This study shows that a contextual just-in-time mobile app intervention resulted in a greater reduction in the dietary sodium intake in adults with hypertension than that in the control group over a 8-week period, as measured by the estimated 24-hour urinary sodium excretion from spot urine and FFQ. The intervention group did not show a significant difference from the control group in the self-confidence in following a low sodium diet and in the 24-hour urinary sodium excretion or dietary intake of sodium as measured by the 24-hour dietary recall. A larger clinical trial is warranted to further elucidate the effects of the LowSalt4Life intervention on sodium intake and blood pressure levels in adults with hypertension.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03099343; https://clinicaltrials.gov/ct2/show/NCT03099343.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/11282.",2020,"There was not a statistically significant difference in self-confidence following a low sodium diet, 24-hour urinary sodium excretion or dietary intake of sodium measured by 24-hour dietary recall compared to control over 8 weeks.","['adults with hypertension, a contextual just-in-time mobile application intervention', 'adults with hypertension', '50 patients aged ≥18 years with treated hypertension']","['mobile application (LowSalt4Life) or usual care (No App', 'LowSalt4Life intervention', 'novel contextual just-in-time mobile application intervention']","['systolic BP change', 'change in sodium intake measured by FFQ and 24-hour urinary sodium excretion, as well as self-reported confidence in following a low sodium diet, and blood pressure (BP', 'blood pressure', 'self-confidence', 'change in 24-hour urinary sodium excretion', 'dietary sodium intake', '24-hour urinary sodium excretion', 'Kawasaki estimated 24-hour urinary sodium excretion', 'Food Frequency Questionnaire (FFQ', '24-hour urinary sodium excretion or dietary intake of sodium measured by 24-hour dietary recall', 'sodium intake and blood pressure', 'estimated sodium intake by 24-hour dietary recall']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0012169', 'cui_str': 'Low sodium diet'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0425433', 'cui_str': 'Dietary sodium intake'}, {'cui': 'C0026691', 'cui_str': 'Acute febrile mucocutaneous lymph node syndrome'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",50.0,0.0406352,"There was not a statistically significant difference in self-confidence following a low sodium diet, 24-hour urinary sodium excretion or dietary intake of sodium measured by 24-hour dietary recall compared to control over 8 weeks.","[{'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Dorsch', 'Affiliation': 'University of Michigan College of Pharmacy, Ann Arbor, MI, United States.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Cornellier', 'Affiliation': 'University of Michigan Health System, Ann Arbor, MI, United States.'}, {'ForeName': 'Armella D', 'Initials': 'AD', 'LastName': 'Poggi', 'Affiliation': 'University of Michigan Health System, Ann Arbor, MI, United States.'}, {'ForeName': 'Feriha', 'Initials': 'F', 'LastName': 'Bilgen', 'Affiliation': 'University of Michigan Health System, Ann Arbor, MI, United States.'}, {'ForeName': 'Peiyu', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'University of Michigan Health System, Ann Arbor, MI, United States.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'University of Michigan Health System, Ann Arbor, MI, United States.'}, {'ForeName': 'Lawrence C', 'Initials': 'LC', 'LastName': 'An', 'Affiliation': 'University of Michigan Health System, Ann Arbor, MI, United States.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Hummel', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI, United States.'}]",JMIR mHealth and uHealth,['10.2196/16696']
1475,32671930,Authors' reply re: Incidence and characteristics of pregnancy-related death across ten low- and middle-income geographical regions: secondary analysis of a cluster randomised controlled trial: The underestimated incidence of eclampsia in low-income countries: variation between regions.,,2020,,[],[],['Incidence and characteristics of pregnancy-related death'],[],[],"[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.326366,,"[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Vousden', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Lucy C', 'Initials': 'LC', 'LastName': 'Chappell', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16353']
1476,32674447,Topical Corticosteroids a Viable Solution for Oral Graft Versus Host Disease? A Systematic Insight on Randomized Clinical Trials.,"Background and Objectives:  This research attempts to provide a clear view of the literature on randomized clinical trials (RCTs) concerning the efficacy of topical dexamethasone, clobetasol and budesonide in oral graft versus host disease (GVHD).  Materials and Methods:  An electronic search of the PubMed, Web of Science and Scopus databases was carried out for eligible RCTs. Studies were included if they had adult patients with oral GVHD treatment with topical corticosteroids, and if the RCT study was published in English. The Cochrane Risk of Bias tool was used to assess the quality of these studies. Overall, three RCTs were included (an Open, Randomized, Multicenter Trial; a Randomized Double-Blind Clinical Trial; and an Open-Label Phase II Randomized Trial).  Results:  The trials involved 76 patients, of which 44 patients received topical dexamethasone, 14 patients received topical clobetasol and 18 patients received topical budesonide. Topical agents were most frequently used when oral tissues were the sole site of involvement. It appears that the best overall response is present for budesonide with no difference between the four arms, followed by clobetasol, and then by dexamethasone. The limitation of the current study is mainly represented by the fact that overall response was derived in two of the studies from other parameters. Moreover, both budesonide and clobetasol were used in only one study each, while two assessed dexamethasone.  Conclusions:  Based on the clinical trials, all three agents seem to be effective in treating oral GVHD and had a satisfactory safety profile. There is still a need for assessing high quality RCTs to assess the efficacy of these therapies on a larger cohort.",2020,"It appears that the best overall response is present for budesonide with no difference between the four arms, followed by clobetasol, and then by dexamethasone.","['76 patients, of which 44 patients received', 'Studies were included if they had adult patients with oral GVHD treatment with topical corticosteroids, and if the RCT study was published in English']","['topical clobetasol', 'dexamethasone', 'topical dexamethasone', 'Topical Corticosteroids', 'topical budesonide', 'topical dexamethasone, clobetasol and budesonide', 'budesonide']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018133', 'cui_str': 'Graft versus host disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0376245', 'cui_str': 'English language'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0008992', 'cui_str': 'Clobetasol'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}]",[],76.0,0.24645,"It appears that the best overall response is present for budesonide with no difference between the four arms, followed by clobetasol, and then by dexamethasone.","[{'ForeName': 'Arin', 'Initials': 'A', 'LastName': 'Sava', 'Affiliation': 'Department of Oral Rehabilitation, University of Medicine and Pharmacy ""Iuliu Hatieganu"", 400012 Cluj-Napoca, Romania.'}, {'ForeName': 'Andra', 'Initials': 'A', 'LastName': 'Piciu', 'Affiliation': 'Department of Medical Oncology, University of Medicine and Pharmacy ""Iuliu Hatieganu"", 400012 Cluj-Napoca, Romania.'}, {'ForeName': 'Sergiu', 'Initials': 'S', 'LastName': 'Pasca', 'Affiliation': 'Department of Hematology, University of Medicine and Pharmacy ""Iuliu Hatieganu"", 400012 Cluj-Napoca, Romania.'}, {'ForeName': 'Alexandru', 'Initials': 'A', 'LastName': 'Mester', 'Affiliation': 'Department of Oral Health, University of Medicine and Pharmacy ""Iuliu Hatieganu"", 400012 Cluj-Napoca, Romania.'}, {'ForeName': 'Ciprian', 'Initials': 'C', 'LastName': 'Tomuleasa', 'Affiliation': 'Department of Hematology, University of Medicine and Pharmacy ""Iuliu Hatieganu"", 400012 Cluj-Napoca, Romania.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56070349']
1477,32676977,"A Phase I, Randomized, Single‑Blind, Placebo‑Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Oral TRV250, a G Protein-Selective Delta Receptor Agonist, in Healthy Subjects.","BACKGROUND


The delta opioid receptor (DOR) has been identified as a therapeutic target for migraine, with DOR agonists exhibiting low abuse potential compared with conventional µ-opioid agonists. TRV250 is a novel small molecule agonist of the DOR that is preferentially selective for G-protein signaling, with relatively little activation of the β-arrestin2 post-receptor signaling pathway. This selectivity provides reduced susceptibility to proconvulsant activity seen with non-selective DOR agonists. TRV250 significantly reduced nitroglycerin-evoked hyperalgesia in rodents, indicating a potential utility in acute migraine without the risk of seizure activity or abuse potential.
OBJECTIVE


This trial evaluated the safety, tolerability, and pharmacokinetics of ascending dose levels of TRV250 administered subcutaneously (SC) and the relative bioavailability of TRV250 administered orally compared with SC administration.
METHODS


This was a two-part, single ascending dose study. Part A included four cohorts of healthy adults (N = 38). Each cohort was dosed on three occasions (placebo and two different dose levels of TRV250, allocated in randomized order and administered by SC route). In Part B, a single cohort of nine subjects received an oral dose of either TRV250 (n = 7) or placebo (n = 2) in a fed or fasted state. Serial blood samples were obtained for pharmacokinetic determination across a 24-h post-dose period. Safety assessments included clinical laboratory measures, vital signs, 12-lead electrocardiogram (ECG), and electroencephalogram (EEG) pre- and post-dosing.
RESULTS


TRV250 was well tolerated. There were no serious adverse events (SAEs), and all AEs were mild in severity. Injection-site reactions and headache were the most common AEs. One subject was withdrawn from the study due to a TRV250-related AE of postural orthostatic tachycardia. There were no clinically relevant changes in physical examination, hematology, clinical chemistry, urinalysis, suicidal ideation, or vital signs, with the exception of orthostatic changes in some subjects. No subject experienced abnormalities in EEGs or experienced a change from baseline in heart-rate-corrected QT interval (QTcF) > 60 ms, or an absolute QTcF interval > 480 ms at any post-dosing observation. Peak and total plasma exposure to TRV250 increased in a dose-proportional manner following 0.1-30 mg SC doses, with the mean half-life ranging from 2.39 to 3.76 h. Oral bioavailability of TRV250 ranged from 14% (fasting) to 19% (fed) relative to SC dosing, while administration with food increased the AUC but decreased the rate of absorption as reflected by a modest delay in median time to maximum concentration and a slight reduction in maximum concentration.
CONCLUSION


The findings from the first-in-human study support further evaluation of TRV250, a G-protein selective DOR agonist, in the treatment of acute migraine.",2020,"There were no clinically relevant changes in physical examination, hematology, clinical chemistry, urinalysis, suicidal ideation, or vital signs, with the exception of orthostatic changes in some subjects.","['Part A included four cohorts of healthy adults (N\u2009=\u200938', 'Healthy Subjects']","['occasions (placebo', 'Subcutaneous and Oral TRV250, a G Protein-Selective Delta Receptor Agonist', 'TRV250 administered subcutaneously (SC', 'TRV250', 'placebo']","['clinical laboratory measures, vital signs, 12-lead electrocardiogram (ECG), and electroencephalogram (EEG) pre- and post-dosing', 'absolute QTcF interval\u2009', 'tolerated', 'rate of absorption', 'safety, tolerability, and pharmacokinetics', 'Peak and total plasma exposure to TRV250', 'physical examination, hematology, clinical chemistry, urinalysis, suicidal ideation, or vital signs', 'serious adverse events (SAEs', 'nitroglycerin-evoked hyperalgesia', 'heart-rate-corrected QT interval (QTcF)\u2009']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0086376', 'cui_str': 'G protein'}, {'cui': 'C0140057', 'cui_str': 'delta Opioid Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0008000', 'cui_str': 'Clinical Chemistry'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]",,0.101361,"There were no clinically relevant changes in physical examination, hematology, clinical chemistry, urinalysis, suicidal ideation, or vital signs, with the exception of orthostatic changes in some subjects.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Fossler', 'Affiliation': 'Clinical Development and Quantitative Sciences, Trevena, Inc., 955 Chesterbrook Boulevard, Suite 110, Chesterbrook, PA, 19087, USA. mfossler@trevena.com.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Schmith', 'Affiliation': 'Nuventra Pharma Sciences, Durham, NC, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Greene', 'Affiliation': 'Nuventra Pharma Sciences, Durham, NC, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Lohmer', 'Affiliation': 'Nuventra Pharma Sciences, Durham, NC, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Kramer', 'Affiliation': 'Scientific Operations and Alliance Management, Trevena Inc, 955 Chesterbrook Boulevard, Suite 110, Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Arscott', 'Affiliation': 'Clinical Operations and Medical Affairs Department, Trevena Inc, 955 Chesterbrook Boulevard, Suite 110, Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Ian E', 'Initials': 'IE', 'LastName': 'James', 'Affiliation': 'Clinical Operations and Medical Affairs Department, Trevena Inc, 955 Chesterbrook Boulevard, Suite 110, Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Demitrack', 'Affiliation': 'Clinical Operations and Medical Affairs Department, Trevena Inc, 955 Chesterbrook Boulevard, Suite 110, Chesterbrook, PA, 19087, USA.'}]",CNS drugs,['10.1007/s40263-020-00738-0']
1478,32677037,Nutritional interventions for treating foot ulcers in people with diabetes.,"BACKGROUND


Foot ulcers in people with diabetes are non-healing, or poorly healing, partial, or full-thickness wounds below the ankle. These ulcers are common, expensive to manage and cause significant morbidity and mortality. The presence of a wound has an impact on nutritional status because of the metabolic cost of repairing tissue damage, in addition to the nutrient losses via wound fluid. Nutritional interventions may improve wound healing of foot ulcers in people with diabetes.
OBJECTIVES


To evaluate the effects of nutritional interventions on the healing of foot ulcers in people with diabetes.
SEARCH METHODS


In March 2020 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.
SELECTION CRITERIA


We included randomised controlled trials (RCTs) that evaluated the effect of nutritional interventions on the healing of foot ulcers in people with diabetes.
DATA COLLECTION AND ANALYSIS


Two review authors, working independently, assessed included RCTs for their risk of bias and rated the certainty of evidence using GRADE methodology, using pre-determined inclusion and quality criteria.
MAIN RESULTS


We identified nine RCTs (629 participants). Studies explored oral nutritional interventions as follows: a protein (20 g protein per 200 mL bottle), 1 kcal/mL ready-to-drink, nutritional supplement with added vitamins, minerals and trace elements; arginine, glutamine and β-hydroxy-β-methylbutyrate supplement; 220 mg zinc sulphate supplements; 250 mg magnesium oxide supplements; 1000 mg/day omega-3 fatty acid from flaxseed oil; 150,000 IU of vitamin D, versus 300,000 IU of vitamin D; 250 mg magnesium oxide plus 400 IU vitamin E and 50,000 IU vitamin D supplements. The comparator in eight studies was placebo, and in one study a different dose of vitamin D. Eight studies reported the primary outcome measure of ulcer healing; only two studies reported a measure of complete healing. Six further studies reported measures of change in ulcer dimension, these studies reported only individual parameters of ulcer dimensions (i.e. length, width and depth) and not change in ulcer volume. All of the evidence identified was very low certainty. We downgraded it for risks of bias, indirectness and imprecision. It is uncertain whether oral nutritional supplement with 20 g protein per 200 mL bottle, 1 kcal/mL, nutritional supplement with added vitamins, minerals and trace elements, increases the proportion of ulcers healed at six months more than placebo (risk ratio (RR) 0.80, 95% confidence interval (CI) 0.42 to 1.53). It is also uncertain whether arginine, glutamine and β-hydroxy-β-methylbutyrate supplement increases the proportion of ulcers healed at 16 weeks compared with placebo (RR 1.09, 95% CI 0.85 to 1.40). It is uncertain whether the following interventions change parameters of ulcer dimensions over time when compared with placebo; 220 mg zinc sulphate supplement containing 50 mg elemental zinc, 250 mg magnesium oxide supplement, 1000 mg/day omega-3 fatty acid from flaxseed oil supplement, magnesium and vitamin E co-supplementation and vitamin D supplementation. It is also uncertain whether 150,000 IU of vitamin D, impacts ulcer dimensions when compared with 300,000 IU of vitamin D. Two studies explored some of the secondary outcomes of interest for this review. It is uncertain whether oral nutritional supplement with 20 g protein per 200 mL bottle, 1 kcal/mL, nutritional supplement with added vitamins, minerals and trace elements, reduces the number of deaths (RR 0.96, 95% CI 0.06 to 14.60) or amputations (RR 4.82, 95% CI 0.24 to 95.88) more than placebo. It is uncertain whether arginine, glutamine and β-hydroxy-β-methylbutyrate supplement increases health-related quality of life at 16 weeks more than placebo (MD -0.03, 95% CI -0.09 to 0.03). It is also uncertain whether arginine, glutamine and β-hydroxy-β-methylbutyrate supplement reduces the numbers of new ulcers (RR 1.04, 95% CI 0.71 to 1.51), or amputations (RR 0.66, 95% CI 0.16 to 2.69) more than placebo. None of the included studies reported the secondary outcomes cost of intervention, acceptability of the intervention (or satisfaction) with respect to patient comfort, length of patient hospital stay, surgical interventions, or osteomyelitis incidence. One study exploring the impact of arginine, glutamine and β-hydroxy-β-methylbutyrate supplement versus placebo did not report on any relevant outcomes.
AUTHORS' CONCLUSIONS


Evidence for the impact of nutritional interventions on the healing of foot ulcers in people with diabetes compared with no nutritional supplementation, or compared with a different dose of nutritional supplementation, remains uncertain, with eight studies showing no clear benefit or harm. It is also uncertain whether there is a difference in rates of adverse events, amputation rate, development of new foot ulcers, or quality of life, between nutritional interventions and placebo. More research is needed to clarify the impact of nutritional interventions on the healing of foot ulcers in people with diabetes.",2020,"It is also uncertain whether there is a difference in rates of adverse events, amputation rate, development of new foot ulcers, or quality of life, between nutritional interventions and placebo.",['people with diabetes'],"['arginine, glutamine and β-hydroxy-β-methylbutyrate', 'magnesium oxide plus 400\u2009IU vitamin E and 50,000 IU vitamin D supplements', 'Nutritional interventions', 'nutritional interventions', 'kcal/mL ready-to-drink, nutritional supplement with added vitamins, minerals and trace elements; arginine, glutamine and β-hydroxy-β-methylbutyrate supplement; 220 mg zinc sulphate supplements; 250 mg magnesium oxide supplements; 1000 mg/day omega-3 fatty acid from flaxseed oil; 150,000 IU of vitamin D', 'magnesium oxide supplement, 1000 mg/day omega-3 fatty acid from flaxseed oil supplement, magnesium and vitamin E co-supplementation and vitamin D supplementation', 'vitamin D', 'arginine, glutamine and β-hydroxy-β-methylbutyrate supplement versus placebo', 'placebo']","['ulcer healing', 'health-related quality of life', 'wound healing of foot ulcers', 'numbers of new ulcers', 'complete healing', 'number of deaths', 'proportion of ulcers healed', 'healing of foot ulcers', 'acceptability of the intervention (or satisfaction) with respect to patient comfort, length of patient hospital stay, surgical interventions, or osteomyelitis incidence', 'rates of adverse events, amputation rate, development of new foot ulcers, or quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0024477', 'cui_str': 'Magnesium Oxide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0560598', 'cui_str': 'kcal/mL'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0078794', 'cui_str': 'Zinc Sulfate'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0030015', 'cui_str': 'Oxides'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0023754', 'cui_str': 'Linseed Oil'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0333293', 'cui_str': 'Healing ulcer'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0085119', 'cui_str': 'Ulcer of foot'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0029443', 'cui_str': 'Osteomyelitis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",,0.351557,"It is also uncertain whether there is a difference in rates of adverse events, amputation rate, development of new foot ulcers, or quality of life, between nutritional interventions and placebo.","[{'ForeName': 'Zena Eh', 'Initials': 'ZE', 'LastName': 'Moore', 'Affiliation': 'School of Nursing & Midwifery, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Meave A', 'Initials': 'MA', 'LastName': 'Corcoran', 'Affiliation': 'Department of Endocrinology, Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'Declan', 'Initials': 'D', 'LastName': 'Patton', 'Affiliation': 'School of Nursing & Midwifery, Royal College of Surgeons in Ireland, Dublin, Ireland.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD011378.pub2']
1479,32674280,A Phase 2 Clinical Trial on the Use of Cibinetide for the Treatment of Diabetic Macular Edema.,"PURPOSE


Evaluating the effects of cibinetide in diabetic macular edema (DME).
METHODS


Phase 2 trial. Naïve patients with >400 µm central retinal thickness (CRT) DME in one/both eyes were recruited (May 2016-April 2017) at the Belfast Health and Social Care Trust. The study eye was that with best vision and lowest CRT. Patients self-administered cibinetide 4 mg/day subcutaneously for 12 weeks. Primary and secondary outcomes: mean change from baseline to week 12 in best corrected visual acuity (BCVA), CRT, central retinal sensitivity, tear production, patient-reported outcomes, adverse events and antibodies to cibinetide. Descriptive statistics were used; exploratory analyses focused on non-study eyes, diabetic control, serum cytokines and albuminuria.
RESULTS


Nine patients were recruited; eight completed the study. There was no improvement in mean change baseline-week 12 in BCVA (-2.9 + 5.0), CRT (10 + 94.6 microns), central retinal sensitivity (-0.53 + 1.9 dB) or tear production (-0.13 + 7.7 mm), but there was an improvement in National Eye Institute Visual Function Questionnaire (NEI VFQ-25) composite scores (2.7 + 3.1). Some participants experienced improvements in CRT, tear production, diabetic control and albuminuria. No serious adverse events/reactions or anti-cibinetide antibodies were seen.
CONCLUSIONS


The cibinetide 12-week course was safe. Improvements in NEI VFQ-25 scores, CRT, tear production, diabetic control and albuminuria, observed in some participants, warrant further investigation.
TRIAL REGISTRATION


EudraCT number: 2015-001940-12. ISRCTN16962255-registration date 25.06.15.",2020,"Improvements in NEI VFQ-25 scores, CRT, tear production, diabetic control and albuminuria, observed in some participants, warrant further investigation.
","['Diabetic Macular Edema', 'diabetic macular edema (DME', 'Naïve patients with >400 µm central retinal thickness (CRT) DME in one/both eyes were recruited (May 2016-April 2017) at the Belfast Health and Social Care Trust', 'Nine patients were recruited; eight completed the study']","['Cibinetide', 'cibinetide']","['NEI VFQ-25 scores, CRT, tear production, diabetic control and albuminuria', 'central retinal sensitivity', 'corrected visual acuity (BCVA), CRT, central retinal sensitivity, tear production, patient-reported outcomes, adverse events and antibodies to cibinetide', 'National Eye Institute Visual Function Questionnaire (NEI VFQ-25) composite scores', 'tear production', 'CRT, tear production, diabetic control and albuminuria', 'diabetic control, serum cytokines and albuminuria', 'mean change baseline-week 12 in BCVA']","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0229118', 'cui_str': 'Structure of both eyes'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0419189', 'cui_str': 'Social care'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4519283', 'cui_str': 'cibinetide'}]","[{'cui': 'C1955969', 'cui_str': 'National Eye Institute'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0423153', 'cui_str': 'Lacrimation'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C4519283', 'cui_str': 'cibinetide'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}]",9.0,0.0339834,"Improvements in NEI VFQ-25 scores, CRT, tear production, diabetic control and albuminuria, observed in some participants, warrant further investigation.
","[{'ForeName': 'Noemi', 'Initials': 'N', 'LastName': 'Lois', 'Affiliation': 'The Wellcome-Wolfson Institute for Experimental Medicine, Queens University Belfast, 97 Lisburn Road, Belfast BT9 7BL, UK.'}, {'ForeName': 'Evie', 'Initials': 'E', 'LastName': 'Gardner', 'Affiliation': 'The Northern Ireland Clinical Trials Unit (NICTU), 1st Floor, Elliott Dynes Centre, Royal Hospitals, Belfast BT12 6BA, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McFarland', 'Affiliation': 'Pharmacy Department, Royal Group of Hospitals, Belfast BT12 6BA, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Armstrong', 'Affiliation': 'The Wellcome-Wolfson Institute for Experimental Medicine, Queens University Belfast, 97 Lisburn Road, Belfast BT9 7BL, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'McNally', 'Affiliation': 'The Northern Ireland Clinical Trials Unit (NICTU), 1st Floor, Elliott Dynes Centre, Royal Hospitals, Belfast BT12 6BA, UK.'}, {'ForeName': 'Nuala Jane', 'Initials': 'NJ', 'LastName': 'Lavery', 'Affiliation': 'The Wellcome-Wolfson Institute for Experimental Medicine, Queens University Belfast, 97 Lisburn Road, Belfast BT9 7BL, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Campbell', 'Affiliation': 'The Northern Ireland Clinical Trials Unit (NICTU), 1st Floor, Elliott Dynes Centre, Royal Hospitals, Belfast BT12 6BA, UK.'}, {'ForeName': 'Rita I', 'Initials': 'RI', 'LastName': 'Kirk', 'Affiliation': 'Araim Pharmaceuticals, 580 White Plains Road, Suite 210, Tarrytown, NY 10591, USA.'}, {'ForeName': 'Daiva', 'Initials': 'D', 'LastName': 'Bajorunas', 'Affiliation': 'Araim Pharmaceuticals, 580 White Plains Road, Suite 210, Tarrytown, NY 10591, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Dunne', 'Affiliation': 'Araim Pharmaceuticals, 580 White Plains Road, Suite 210, Tarrytown, NY 10591, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Cerami', 'Affiliation': 'Araim Pharmaceuticals, 580 White Plains Road, Suite 210, Tarrytown, NY 10591, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Brines', 'Affiliation': 'Araim Pharmaceuticals, 580 White Plains Road, Suite 210, Tarrytown, NY 10591, USA.'}]",Journal of clinical medicine,['10.3390/jcm9072225']
1480,32673233,Efficacy of a Guided Web-Based Self-Management Intervention for Depression or Dysthymia: Randomized Controlled Trial With a 12-Month Follow-Up Using an Active Control Condition.,"BACKGROUND


An increasing number of studies suggest that web-based interventions for patients with depression can reduce their symptoms and are expected to fill currently existing treatment gaps. However, evidence for their efficacy has mainly been derived from comparisons with wait-list or treatment as usual controls. In particular, designs using wait-list controls are unlikely to induce hope and may even have nocebo effects, making it difficult to draw conclusions about the intervention's efficacy. Studies using active controls are rare and have not yielded conclusive results.
OBJECTIVE


The main objective of this study is to assess the acute and long-term antidepressant efficacy of a 6-week, guided, web-based self-management intervention building on the principles of cognitive behavioral therapy (iFightDepression tool) for patients with depression compared with web-based progressive muscle relaxation as an active control condition.
METHODS


A total of 348 patients with mild-to-moderate depressive symptoms or dysthymia (according to the Mini International Neuropsychiatric Interview) were recruited online and randomly assigned to 1 of the 2 intervention arms. Acute antidepressant effects after 6 weeks and long-term effects at 3-, 6-, and 12-month follow-up were studied using the Inventory of Depressive Symptomatology-self-rating as a primary outcome parameter and change in quality of life (Short Form 12) and user satisfaction (client satisfaction questionnaire) as secondary outcome parameters. Treatment effects were assessed using mixed model analyses.
RESULTS


Over the entire observation period, a greater reduction in symptoms of depression (P=.01) and a greater improvement of life quality (P<.001) was found in the intervention group compared with the active control group. Separate tests for each time point revealed significant effects on depressive symptoms at the 3-month follow-up (d=0.281; 95% CI 0.069 to 0.493), but not after 6 weeks (main outcome:d=0.192; 95% CI -0.020 to 0.404) and 6 and 12 months. The intervention was significantly superior to the control condition with respect to user satisfaction (25.31 vs 21.97; t 259 =5.804; P<.01).
CONCLUSIONS


The fact that antidepressant effects have been found for a guided self-management tool in comparison with an active control strengthens the evidence base for the efficacy of web-based interventions. The antidepressant effect became most prominent at the 3-month follow-up. After 6 weeks of intervention, significant positive effects were observed on life quality but not on depressive symptoms. Although the effect size of such web-based interventions on symptoms of depression might be smaller than that suggested by earlier studies using wait-list control conditions, they can be a cost-effective addition to antidepressants and face-to-face psychotherapy.
TRIAL REGISTRATION


International Clinical Trials Registry Platform ICTRP080-15-09032015; https://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00009323.",2020,"Over the entire observation period, a greater reduction in symptoms of depression (P=.01) and a greater improvement of life quality (P<.001) was found in the intervention group compared with the active control group.","['patients with depression', '348 patients with mild-to-moderate depressive symptoms or dysthymia (according to the Mini International Neuropsychiatric Interview', 'patients with depression compared with web-based progressive muscle relaxation as an active control condition', 'Depression or Dysthymia']","['Guided Web-Based Self-Management Intervention', 'cognitive behavioral therapy (iFightDepression tool']","['Acute antidepressant effects', 'symptoms of depression', 'life quality', 'quality of life (Short Form 12) and user satisfaction (client satisfaction questionnaire', 'depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0013415', 'cui_str': 'Dysthymia'}, {'cui': 'C4505426', 'cui_str': 'Mini International Neuropsychiatric Interview'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",348.0,0.133249,"Over the entire observation period, a greater reduction in symptoms of depression (P=.01) and a greater improvement of life quality (P<.001) was found in the intervention group compared with the active control group.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Oehler', 'Affiliation': 'German Depression Foundation, Leipzig, Germany.'}, {'ForeName': 'Frauke', 'Initials': 'F', 'LastName': 'Görges', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Leipzig, Leipzig, Germany.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Rogalla', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Leipzig, Leipzig, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rummel-Kluge', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Leipzig, Leipzig, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Hegerl', 'Affiliation': 'Department of Psychiatry, Psychosomatics and Psychotherapy, Goethe-Universität Frankfurt, Frankfurt, Germany.'}]",Journal of medical Internet research,['10.2196/15361']
1481,32673255,Assessment of the Effectiveness and Cost-Effectiveness of Tailored Web- and Text-Based Smoking Cessation Support in Primary Care (iQuit in Practice II): Protocol for a Randomized Controlled Trial.,"BACKGROUND


The prevalence of smoking is declining; however, it continues to be a major public health burden. In England, primary care is the health setting that provides smoking cessation support to most smokers. However, this setting has one of the lowest success rates. The iQuit in practice intervention (iQuit) is a tailored web-based and text message intervention developed for use in primary care consultations as an adjunct to routine smoking cessation support with the aim of increasing success rates. iQuit has demonstrated feasibility, acceptability, and potential effectiveness.
OBJECTIVE


This definitive trial aims to determine the effectiveness and cost-effectiveness of iQuit when used as an adjunct to the usual support provided to patients who wish to quit smoking, compared with usual care alone.
METHODS


The iQuit in Practice II trial is a two-arm, parallel-group, randomized controlled trial (RCT) with a 1:1 individual allocation comparing usual care (ie, pharmacotherapy combined with multisession behavioral support)-the control-with usual care plus iQuit-the intervention. Participants were recruited through primary care clinics and talked to a smoking cessation advisor. Participants were randomized during the initial consultation, and those allocated to the intervention group received a tailored advice report and 90 days of text messaging in addition to the standard support provided to all patients.
RESULTS


The primary outcome is self-reported prolonged abstinence biochemically verified using saliva cotinine at 6 months after the quit date. A sample size of 1700 participants, with 850 per arm, would yield 90% power to detect a 4.3% difference in validated quit rates between the groups at the two-sided 5% level of significance. The Cambridge East Research Ethics Committee approved the study in February 2016, and funding for the study was granted from May 2016. In total, 1671 participants were recruited between August 2016 and July 2019. Follow-up for all participants was completed in January 2020. Data analysis will begin in the summer of 2020.
CONCLUSIONS


iQuit in Practice II is a definitive, pragmatic RCT assessing whether a digital intervention can augment the impact of routine smoking cessation support in primary care. Previous research has found good acceptability and feasibility for delivering iQuit among smoking cessation advisors working in primary care. If demonstrated to be cost-effective, iQuit could be delivered across primary care and other settings, such as community pharmacies. The potential benefit would likely be highest where less behavioral support is delivered.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number (ISRCTN): 44559004; http://www.isrctn.com /ISRCTN44559004.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17160.",2020,The iQuit in practice intervention (iQuit) is a tailored web-based and text message intervention developed for use in primary care consultations as an adjunct to routine smoking cessation support with the aim of increasing success rates.,"['patients who wish to quit smoking, compared with usual care alone', '1671 participants were recruited between August 2016 and July 2019', 'Primary Care (iQuit in Practice II', 'Participants were recruited through primary care clinics and talked to a smoking cessation advisor']","['tailored advice report and 90 days of text messaging in addition to the standard support provided to all patients', 'Tailored Web- and Text-Based Smoking Cessation Support', 'usual care (ie, pharmacotherapy combined with multisession behavioral support)-the control-with usual care plus iQuit-the intervention']","['self-reported prolonged abstinence biochemically verified using saliva cotinine', 'validated quit rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]","[{'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}]",1671.0,0.0975898,The iQuit in practice intervention (iQuit) is a tailored web-based and text message intervention developed for use in primary care consultations as an adjunct to routine smoking cessation support with the aim of increasing success rates.,"[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Proctor', 'Affiliation': 'University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Naughton', 'Affiliation': 'University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Sloan', 'Affiliation': 'University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hopewell', 'Affiliation': 'University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Brimicombe', 'Affiliation': 'University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'A Toby', 'Initials': 'AT', 'LastName': 'Prevost', 'Affiliation': 'Imperial College London, London, United Kingdom.'}, {'ForeName': 'Edward C F', 'Initials': 'ECF', 'LastName': 'Wilson', 'Affiliation': 'University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Coleman', 'Affiliation': 'University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sutton', 'Affiliation': 'University of Cambridge, Cambridge, United Kingdom.'}]",JMIR research protocols,['10.2196/17160']
1482,32678713,Optimization of Photobiomodulation Protocol for Chemotherapy-Induced Mucositis in Pediatric Patients.,"Objective:  To determine optimal settings of a specific diode laser for reducing the severity of oral mucositis (OM) in pediatric patients.  Background:  Photobiomodulation (PBM) has been reported to reduce the severity of chemotherapy-induced OM. Treatment parameters for PBM are difficult to determine due to different reports in the literature.  Materials and methods:  Patients with OM graded WHO 3 or 4 were randomly assigned to three groups with different laser settings (group A: power 250 mW, the energy density 8.8 and 15.5 J/cm 2  for WHO grade 3 and 4, respectively; group B: power 500 mW, energy density as in group A; group C: power 250 mW, energy density was half of groups A and B). PBM was performed on all lesion areas. The mean number of PBM sessions to a decrease from WHO 3 or 4 to WHO 2, 1, or 0 was calculated for each patient. Multiple linear regression was used to determine whether the test groups differed in the mean number of sessions to a decrease of OM.  Results:  The mean number of PBM sessions to reduce from severe mucositis to mild or no mucositis was 3.8 [standard deviation (SD) = 3.5] in group A, 4.4 (SD = 2.3) in group B, and 4.0 (SD = 2.7) in group C. The differences in the number of PBM sessions for OM severity decrease were not statistically significantly different among the three study groups.  Conclusions:  Because of the lack of statistically significant differences between the groups, more patient practical laser parameters could be applied, that is, a shorter irradiation time.",2020,Multiple linear regression was used to determine whether the test groups differed in the mean number of sessions to a decrease of OM.  ,"['Patients with OM graded WHO 3 or 4', 'Pediatric Patients', 'pediatric patients']","[':  Photobiomodulation (PBM', 'specific diode laser']","['number of PBM sessions for OM severity decrease', 'mean number of PBM sessions', 'severe mucositis to mild or no mucositis', 'severity of oral mucositis (OM', 'PBM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0065764', 'cui_str': 'MBD protocol'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0065764', 'cui_str': 'MBD protocol'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}]",,0.0295031,Multiple linear regression was used to determine whether the test groups differed in the mean number of sessions to a decrease of OM.  ,"[{'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Tomaževič', 'Affiliation': 'Department of Paediatric and Preventive Dentistry, Dental Clinic, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Urša', 'Initials': 'U', 'LastName': 'Potočnik', 'Affiliation': 'Dental Studio Škrlj Golob, Domžale, Slovenia.'}, {'ForeName': 'Daša', 'Initials': 'D', 'LastName': 'Cizerl', 'Affiliation': 'Department of Paediatric and Preventive Dentistry, Dental Clinic, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Janez', 'Initials': 'J', 'LastName': 'Jazbec', 'Affiliation': ""Department of Oncology and Haematology, Children's Hospital, University Medical Centre Ljubljana, Ljubljana, Slovenia.""}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2019.4794']
1483,32678725,"A randomized blinded retrospective study: the combined use of micro-needling technique, low-level laser therapy and autologous non-activated platelet-rich plasma improves hair re-growth in patients with androgenic alopecia.","INTRODUCTION


Mini-invasive therapies based on autologous non-activated Platelet-Rich Plasma (ANA-PRP), Low-Level Laser Therapy (LLL-T), and Micro-Needling Technique (MN-T) used in combining for hair re-growth need to be standardized.
OBJECTIVES


The work aims to show  in vivo  outcomes resulted from retrospective case-series study in which ANA-PRP + MN-T + LLL-T were used in combined in patients affected by Androgenic alopecia.
METHODS


23 patients were treated, of which 13 males were classified in stage I-V by the Norwood-Hamilton scale, and 10 females were classified in stage I-III by the Ludwig scale. Assessment of hair re-growth was evaluated with photography, physician's and patient's global assessment scale, and standardized phototrichograms during a follow-up: T0 - baseline, T1 - 12 weeks, T2 - 23 weeks, T3 - 44 weeks, T4 - 58 weeks.
RESULTS


Interesting outcomes represented by a hair density increase of 81 ± 5 hairs/cm 2  and 57 ± 7 hairs/cm 2  respectively at T1 and T2 compared with baseline (173 ± 5 hairs/cm 2  at T1 and 149 ± 9 hairs/cm 2  at T2 versus 92 ± 2 hairs/cm 2  at baseline) were observed using computerized trichograms.
EXPERT OPINION


The main limitation in the autologous regenerative therapies and biotechnologies in hair-regrowth is the extreme variability of PRP products used, in the absence of standardized protocols and widely shared. Appropriate PRP preparations have to be pick after carefully thinking about their bio-molecular specifications and intended indications for use in patients. This approach will aid in matching the optimal PRP product to specific patient factors, leading to improved outcomes and the elucidation of the cost-effectiveness of this treatment. The combined use of biotechnologies as the association of PRP with micro-needling and low-level laser therapy may improve the results in terms of hair count and hair density compared with those obtained by alone PRP. All the procedures must be performed in the full respect of international and local rules.
CONCLUSIONS


The effect of the combined use of MN-T, LLL-T, and ANA-PRP has been demonstrated.",2020,"Interesting outcomes represented by a hair density increase of 81 ± 5 hairs/cm 2  and 57 ± 7 hairs/cm 2  respectively at T1 and T2 compared with baseline (173 ± 5 hairs/cm 2  at T1 and 149 ± 9 hairs/cm 2  at T2 versus 92 ± 2 hairs/cm 2  at baseline) were observed using computerized trichograms.
","['patients with Androgenic Alopecia', '23 patients were treated, of which 13 males were classified in stage I - V by the Norwood-Hamilton scale, and 10 females were classified in stage I - III by the Ludwig scale']","['Micro-needling Technique, Low-Level Laser Therapy and Autologous Non-Activated Platelet-Rich Plasma', 'ANA-PRP + MN-T + LLL-T', 'MN-T, LLL-T, and ANA-PRP', 'Mini-invasive therapies based on autologous non-activated Platelet-Rich Plasma (ANA-PRP), Low-Level Laser Therapy (LLL-T), and Micro-Needling Technique (MN-T']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0024081', 'cui_str': ""Ludwig's angina""}]","[{'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],13.0,0.0364,"Interesting outcomes represented by a hair density increase of 81 ± 5 hairs/cm 2  and 57 ± 7 hairs/cm 2  respectively at T1 and T2 compared with baseline (173 ± 5 hairs/cm 2  at T1 and 149 ± 9 hairs/cm 2  at T2 versus 92 ± 2 hairs/cm 2  at baseline) were observed using computerized trichograms.
","[{'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Gentile', 'Affiliation': 'Department of Surgical Sciences, Plastic and Reconstructive Surgery, University of Rome ""Tor Vergata"" School of Medicine , Rome, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dionisi', 'Affiliation': 'Dionisi Law Firm , Rome, Italy.'}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Pizzicannella', 'Affiliation': 'ASL02 Lanciano-Vasto Chieti, Ss. Annunziata Hospital , Chieti, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'de Angelis', 'Affiliation': 'Department of Surgical Sciences, Plastic and Reconstructive Surgery, University of Rome ""Tor Vergata"" School of Medicine , Rome, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'de Fazio', 'Affiliation': 'Institute of Plastic Surgery, Galeazzi Hospital , Milan, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Garcovich', 'Affiliation': 'Institute of Dermatology, F. Policlinico Gemelli IRCSS, Università Cattolica del Sacro Cuore , Rome, Italy.'}]",Expert opinion on biological therapy,['10.1080/14712598.2020.1797676']
1484,32679755,Effects of 3D Moving Platform Exercise on Physiological Parameters and Pain in Patients with Chronic Low Back Pain.,"Background and objectives:  Patient-handling activities predispose women to chronic low back pain (CLBP), but sufficient evidence is not available on whether a 3D moving platform, made for core stability exercise, affects pain, trunk flexibility, and static/dynamic muscle contractions in CLBP patients.  Materials and Methods:  The participants were twenty-nine women who were randomly divided into a control group (CON) and a 3D exercise group (3DEG), which took part in 3D moving exercise three times a week for 8 weeks. Both groups measured a visual analog scale (VAS) about their CLBP. Body composition, forward and backward trunk flexibilities, static muscle contraction property in rectus abdominis, and erector spinae were measured by tensiomyography, which found contraction time (Tc) and maximal displacement (Dm). Dynamic muscle contraction property in the abdomen and back were measured with an isokinetic device, which could measure peak torque (Pt) and work per repetition (Wr), before and after the trial.  Results:  The 3DEG had a significantly decreased fat mass and waist/hip ratio, as well as improved static muscle contractions of the erector spinae. The Wr of trunk extensor of 3D exercise group were also significantly increased. In the VAS, although the scores showed a significant change in some variables, while others did not. The Δ% in feeling pain at rest or at night, during exercise, walking, sitting in a hard chair, sitting in a soft chair, and lying down in 3DEG were significantly changed after 8 weeks. This indicates that the platform exercise provided a greater reduction of pain for activities that are done on a daily basis.  Conclusions : This study confirms that the 3D moving platform exercise can provide the similar effect of the core stability exercise used in previous studies. Moreover, this study suggests that 3D moving platform exercise is a suitable means to reduce fatness, to increase trunk extensor, and to increase trunk backward flexibility, which led to reduced back pain in the women with CLBP.",2020,"The 3DEG had a significantly decreased fat mass and waist/hip ratio, as well as improved static muscle contractions of the erector spinae.","['CLBP patients', 'women with CLBP', 'participants were twenty-nine women', 'Patients with Chronic Low Back Pain', 'Patient-handling activities predispose women to chronic low back pain (CLBP']","['3D Moving Platform Exercise', 'control group (CON) and a 3D exercise group (3DEG']","['pain for activities', 'fat mass and waist/hip ratio', 'visual analog scale (VAS', 'trunk backward flexibility', 'back pain', 'peak torque (Pt) and work per repetition (Wr', 'contraction time (Tc) and maximal displacement (Dm', 'static muscle contractions', 'Physiological Parameters and Pain', 'Body composition, forward and backward trunk flexibilities, static muscle contraction property in rectus abdominis, and erector spinae']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C2350569', 'cui_str': 'Patient Handling'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}]",29.0,0.0385122,"The 3DEG had a significantly decreased fat mass and waist/hip ratio, as well as improved static muscle contractions of the erector spinae.","[{'ForeName': 'Soochul', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Education Major of Physical Education, Graduate School of Education of Hanseo University, Hanseo 1-Ro, Haemi-myeon, Seosan 31962, Korea.'}, {'ForeName': 'Yongseok', 'Initials': 'Y', 'LastName': 'Jee', 'Affiliation': 'Department of Education Major of Physical Education, Graduate School of Education of Hanseo University, Hanseo 1-Ro, Haemi-myeon, Seosan 31962, Korea.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56070351']
1485,32682074,Pulmonary deposition of budesonide/glycopyrronium/formoterol fumarate dihydrate metered dose inhaler formulated using co-suspension delivery technology in healthy male subjects.,"This gamma scintigraphy imaging study assessed pulmonary, extrathoracic and regional lung deposition patterns of a radiolabelled inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β 2 -agonist triple fixed-dose combination budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF 320/14.4/10 μg), delivered by pressurised metered dose inhaler (pMDI) using innovative co-suspension delivery technology (Aerosphere™). In this Phase I, randomised, single-centre, single-dose, two-period, crossover study (NCT03740373), 10 healthy male adults received two actuations of BGF MDI (160/7.2/4.8 μg per actuation) radiolabelled with  99m Tc, not exceeding 5 MBq per actuation. Immediately following each inhalation, subjects performed a 10- or 3-second breath-hold, then exhaled into an exhalation filter. The primary objective was to assess the pulmonary deposition of BGF MDI following the 10-second breath-hold. The secondary objectives were to assess deposition after the 3-second breath-hold and lung regional and extrathoracic deposition after each breath-hold length. Imaging of the lungs, stomach, head and neck was recorded by gamma scintigraphy immediately after exhalation. The mean BGF MDI emitted dose deposited in the lungs was 37.7% for the 10-second breath-hold and 34.5% for the 3-second breath-hold. Emitted dose detected in the exhalation filter was ≤0.4% for both breath-hold lengths. The mean normalised peripheral/central ratio was 0.65 and 0.75 for the 10- and 3-second breath-holds, respectively, while the standardised central/peripheral ratios were 1.79 and 1.40, respectively. There were no new or unexpected safety findings. In conclusion, BGF MDI was efficiently deposited in the central and the peripheral regions of the lungs, with similar regional deposition patterns following a 10- and 3-second breath-hold.",2020,"The mean normalised peripheral/central ratio was 0.65 and 0.75 for the 10- and 3-second breath-holds, respectively, while the standardised central/peripheral ratios were 1.79 and 1.40, respectively.","['10 healthy male adults received', 'healthy male subjects']","['two actuations of BGF MDI', 'budesonide/glycopyrronium/formoterol fumarate dihydrate']","['exhalation filter', 'deposition after the 3-second breath-hold and lung regional and extrathoracic deposition after each breath-hold length', 'mean BGF MDI', 'pulmonary deposition of BGF MDI', 'mean normalised peripheral/central ratio', 'BGF MDI']","[{'cui': 'C0686751', 'cui_str': 'Well male adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C4319628', 'cui_str': 'Actuation'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C1579393', 'cui_str': 'Formoterol fumarate dihydrate'}]","[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",10.0,0.0611695,"The mean normalised peripheral/central ratio was 0.65 and 0.75 for the 10- and 3-second breath-holds, respectively, while the standardised central/peripheral ratios were 1.79 and 1.40, respectively.","[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Israel', 'Affiliation': 'Simbec Research Ltd, Merthyr Tydfil, South Wales, CF48 4DR, UK.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Kelly Services Global LLC, Suite 401A, 999W. Big Beaver Rd., Troy, MI, 48084, USA.'}, {'ForeName': 'Kiernan', 'Initials': 'K', 'LastName': 'DeAngelis', 'Affiliation': 'Formerly of AstraZeneca, 4222 Emperor Blvd, Suite 560, Durham, NC, 27703, USA.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Aurivillius', 'Affiliation': 'AstraZeneca Gothenburg, Pepparedsleden 1, SE-431 50, Mölndal, Sweden.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorinsky', 'Affiliation': 'AstraZeneca, 4222 Emperor Blvd, Suite 560, Durham, NC, 27703, USA. Electronic address: paul.dorinsky1@astrazeneca.com.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Roche', 'Affiliation': 'Respiratory Medicine, Hôpital Cochin (AP-HP), University Paris Descartes, 27 Rue du Faubourg Saint-Jacques, 75014 Paris, France.'}, {'ForeName': 'Omar S', 'Initials': 'OS', 'LastName': 'Usmani', 'Affiliation': 'National Heart and Lung Institute (NHLI), Imperial College London & Royal Brompton Hospital, Guy Scadding Building, Dovehouse St, Chelsea, London SW3 6LY, UK.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2020.105472']
1486,32682174,The renin secretion profile under the influence of sleep deprivation and the neuropeptides CRH and GHRH.,"It is already known that during normal sleep plasma renin activity (PRA) shows oscillations with decreases during rapid-eye-movement (REM) sleep and increases during non-REM (NREM) sleep. We also know that renin correlates positively with slow-wave sleep (SWS). Sleep deprivation is known to enhance significantly SWS and slow wave activity (SWA, known as δ power). Based on these findings we addressed the question whether and to which extent sleep deprivation may affect the synchronization found between PRA and REM sleep during normal sleep and whether this synchronization is affected by other sleep regulating factors. To investigate these questions we compared sleep EEG and sleep-related free renin levels in 48 normal women and men 19-69 years old between nights before and after 40 h of sleep deprivation. During the recovery night, four bolus injections of either GHRH, CRH or placebo were injected via long catheter around sleep onset. When compared to baseline after each of the treatments SWS, SWA and renin levels increased. The characteristical oscillation profiles of renin during normal sleep were also preserved after sleep deprivation. Similar to normal sleep our data support also a distinct link between nocturnal renin secretion and SWS after sleep deprivation and that independent of the applied treatments.",2020,"When compared to baseline after each of the treatments SWS, SWA and renin levels increased.",['48 normal women and men 19-69 years old between nights before and after 40\u2009h of sleep deprivation'],"['GHRH, CRH or placebo']","['renin correlates positively with slow-wave sleep (SWS', 'SWA and renin levels', 'sleep EEG and sleep-related free renin levels']","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]","[{'cui': 'C0037668', 'cui_str': 'Somatotropin releasing factor'}, {'cui': 'C0010132', 'cui_str': 'Corticotropin-Releasing Hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}, {'cui': 'C0038977', 'cui_str': 'Swahili language'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0200101', 'cui_str': 'Sleep electroencephalogram'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",48.0,0.0236425,"When compared to baseline after each of the treatments SWS, SWA and renin levels increased.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Künzel', 'Affiliation': 'Medizinische Klinik und Poliklinik IV, Klinikum der Universität München, Germany; Max-Planck-Institut für Psychiatrie München, Germany. Electronic address: Heike.Kuenzel@med.uni-muenchen.de.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Schüssler', 'Affiliation': 'Max-Planck-Institut für Psychiatrie München, Germany; Universität Regensburg, Klinik und Poliklinik für Psychiatrie, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Yassouridis', 'Affiliation': 'Max-Planck-Institut für Psychiatrie München, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Uhr', 'Affiliation': 'Max-Planck-Institut für Psychiatrie München, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kluge', 'Affiliation': 'Max-Planck-Institut für Psychiatrie München, Germany; Universität Leipzig, Klinik und Poliklinik für Psychiatrie und Psychotherapie, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Steiger', 'Affiliation': 'Max-Planck-Institut für Psychiatrie München, Germany.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104799']
1487,32682277,Effects of repeated exposure to fearful and disgusting stimuli on fear renewal in blood-injection-injury phobia.,"Although exposure is effective for blood-injection-injury (BII) phobia, fear often returns after treatment. While disgust has been implicated in BII phobia, its effects on fear renewal are unclear. To address this knowledge gap, the present study examined the effect of repeated video exposure to fearful and disgusting stimuli in multiple contexts on fear renewal in BII phobia. Individuals with BII phobia (N = 57) were randomized to Disgust-Specific Exposure (DSE) which included exposure to disgusting but threat-irrelevant stimuli (i.e., vomit), Fear-Specific Exposure (FSE) which included exposure to threat-relevant stimuli (i.e., injections), or General Negative Exposure (GNE) which included exposure designed to elicit negative affect (i.e., tornado) without being disgusting or threat-relevant. During session one, participants watched a pre- and post-exposure assessment injection video (""pre/post assessment""), and a novel injection video after exposure to assess renewal effects (""novel 1""). Participants came in one week later to rate the same videos, and a new injection video (""novel 2""). For week one outcomes, comparisons of covariate adjusted means indicated the fear-specific group reported significantly lower levels of anxiety than the general-negative group to the post-exposure and novel 1 stimulus. When presented with the post-exposure stimuli during week two, the disgust-specific and fear-specific groups reported significantly lower levels of anxiety than the general negative group. The fear-specific group also reported significantly lower levels of anxiety than the disgust-specific and general-negative groups when presented with novel 1 and novel 2 stimuli at week two. These findings suggest that repeated exposure to threat-relevant cues in multiple contexts does reduce the return of anxiety. However, repeated exposure to disgusting but threat irrelevant stimuli may also produce some therapeutic effects. The implications of the integration of disgust-relevant processes into exposure-based treatment of BII phobia are discussed.",2020,The fear-specific group also reported significantly lower levels of anxiety than the disgust-specific and general-negative groups when presented with novel 1 and novel 2 stimuli at week two.,"['Individuals with BII phobia (N = 57', 'blood-injection-injury phobia', 'multiple contexts on fear renewal in BII phobia']","['Disgust-Specific Exposure (DSE) which included exposure to disgusting but threat-irrelevant stimuli (i.e., vomit), Fear-Specific Exposure (FSE) which included exposure to threat-relevant stimuli (i.e., injections), or General Negative Exposure', 'repeated exposure to fearful and disgusting stimuli', 'pre- and post-exposure assessment injection video (""pre/post assessment']","['return of anxiety', 'levels of anxiety']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0349231', 'cui_str': 'Phobia'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]","[{'cui': 'C0683283', 'cui_str': 'Disgust'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",57.0,0.00929875,The fear-specific group also reported significantly lower levels of anxiety than the disgust-specific and general-negative groups when presented with novel 1 and novel 2 stimuli at week two.,"[{'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Jessup', 'Affiliation': 'Vanderbilt University, United States.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Tomarken', 'Affiliation': 'Vanderbilt University, United States.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Viar-Paxton', 'Affiliation': 'Vanderbilt University, United States.'}, {'ForeName': 'Bunmi O', 'Initials': 'BO', 'LastName': 'Olatunji', 'Affiliation': 'Vanderbilt University, United States. Electronic address: olubunmi.o.olatunji@vanderbilt.edu.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102272']
1488,32682457,"S-1 plus leucovorin and oxaliplatin versus S-1 plus cisplatin as first-line therapy in patients with advanced gastric cancer (SOLAR): a randomised, open-label, phase 3 trial.","BACKGROUND


S-1 plus leucovorin and oxaliplatin showed promising efficacy for treatment of advanced gastric cancer in a randomised phase 2 study. We aimed to evaluate the efficacy and safety of oral TAS-118 (S-1 plus leucovorin) and oxaliplatin versus S-1 plus cisplatin in patients with advanced gastric cancer.
METHODS


We did a randomised, open-label, phase 3 trial in 62 centres across Japan and South Korea. Patients aged 20 years or older, with a histologically confirmed advanced gastric cancer with negative or unknown HER2 status, with Eastern Cooperative Oncology Group performance status of 0 or 1, measurable or evaluable metastatic lesions, and no previous treatment were randomly assigned (1:1) via an interactive web response system using the minimisation method, stratified by performance status, presence of a measurable lesion, and country, to receive TAS-118 (S-1 40-60 mg and leucovorin 25 mg orally twice daily for 7 days) plus oxaliplatin (85 mg/m 2  intravenously on day 1) every 2 weeks, or S-1 (40-60 mg orally twice daily) for 21 days plus cisplatin (60 mg/m 2  intravenously on day 1 or 8) every 5 weeks. The primary endpoint was overall survival in patients who had advanced gastric cancer with measurable or evaluable metastatic lesions and who received the study drug. Safety was assessed in all patients who received the study drug. This study was registered at ClinicalTrials.gov, NCT02322593.
FINDINGS


Between Jan 28, 2015, and Dec 5, 2016, 711 patients were randomised to TAS-118 plus oxaliplatin (n=356) or S-1 plus cisplatin (n=355). 11 untreated patients and 19 ineligible patients were excluded from the primary analysis (TAS-118 plus oxaliplatin group n=347, S-1 plus cisplatin group n=334) following recommendation from the independent data monitoring committee. After median follow-up of 26·0 months (IQR 22·0-32·8), median overall survival was 16·0 months (95% CI 13·8-18·3) in the TAS-118 plus oxaliplatin group and 15·1 months (95% CI 13·6-16·4) in the S-1 plus cisplatin group (hazard ratio 0·83, 95% CI 0·69-0·99; p=0·039). The most common grade 3 or higher adverse events in the 352 patients in the TAS-118 plus oxaliplatin group and the 348 patients in the S-1 plus cisplatin group were anaemia (56 [16%] vs 64 [18%]), neutropenia (54 [15%] vs 88 [25%]), decreased appetite (53 [15%] vs 46 [13%]), diarrhoea (33 [9%] vs 15 [4%]), and peripheral sensory neuropathy (30 [9%] vs one [<1%]). Serious adverse events were observed in 155 (44%) of 352 patients in the TAS-118 plus oxaliplatin group and 159 (46%) of 348 patients in the S-1 plus cisplatin group. Two treatment-related deaths occurred in the TAS-118 plus oxaliplatin group (pulmonary tuberculosis and viral pneumonia).
INTERPRETATION


TAS-118 plus oxaliplatin showed a clinically meaningful improvement in efficacy compared with S-1 plus cisplatin, and could be considered a new first-line treatment option for advanced gastric cancer in Asian patients.
FUNDING


Taiho Pharmaceutical and Yakult Honsha.",2020,"Two treatment-related deaths occurred in the TAS-118 plus oxaliplatin group (pulmonary tuberculosis and viral pneumonia).
","['advanced gastric cancer in Asian patients', 'patients with advanced gastric cancer (SOLAR', 'Patients aged 20 years or older, with a histologically confirmed advanced gastric cancer with negative or unknown HER2 status, with Eastern Cooperative Oncology Group performance status of 0 or 1, measurable or evaluable metastatic lesions, and no previous treatment', 'patients with advanced gastric cancer', 'Between Jan 28, 2015, and Dec 5, 2016, 711 patients', '11 untreated patients and 19 ineligible patients were excluded from the primary analysis ', '62 centres across Japan and South Korea', 'group n=334) following recommendation from the independent data monitoring committee', 'advanced gastric cancer', 'patients who had advanced gastric cancer with measurable or evaluable metastatic lesions and who received the study drug']","['oxaliplatin', 'TAS-118 (S-1 40-60 mg and leucovorin 25 mg orally twice daily for 7 days) plus oxaliplatin', 'TAS-118 plus oxaliplatin', 'S-1', 'leucovorin and oxaliplatin', 'cisplatin', 'S-1 plus cisplatin', 'S-1 plus leucovorin and oxaliplatin versus S-1 plus cisplatin', 'oral TAS-118 (S-1 plus leucovorin) and oxaliplatin versus S-1 plus cisplatin']","['Safety', 'neutropenia', 'overall survival', 'diarrhoea', 'efficacy and safety', 'anaemia', 'peripheral sensory neuropathy', 'median overall survival', 'adverse events', 'deaths', 'decreased appetite', 'Serious adverse events']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0559483', 'cui_str': 'Pentalogy of Cantrell'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C1125365', 'cui_str': 'Leucovorin 25 MG'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}]",11.0,0.251793,"Two treatment-related deaths occurred in the TAS-118 plus oxaliplatin group (pulmonary tuberculosis and viral pneumonia).
","[{'ForeName': 'Yoon-Koo', 'Initials': 'YK', 'LastName': 'Kang', 'Affiliation': 'Department of Oncology, Asan Medical Centre, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Keisho', 'Initials': 'K', 'LastName': 'Chin', 'Affiliation': 'Department of Gastroenterology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Hyun Cheol', 'Initials': 'HC', 'LastName': 'Chung', 'Affiliation': 'Division of Medical Oncology, Institute for Cancer Research, Yonsei University College of Medicine, Yonsei University Health System, Seoul, South Korea.'}, {'ForeName': 'Shigenori', 'Initials': 'S', 'LastName': 'Kadowaki', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Centre Hospital, Aichi, Japan.'}, {'ForeName': 'Sang Cheul', 'Initials': 'SC', 'LastName': 'Oh', 'Affiliation': 'Department of Oncology, Korea University Guro Hospital, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Norisuke', 'Initials': 'N', 'LastName': 'Nakayama', 'Affiliation': 'Department of Gastroenterology, Kanagawa Cancer Centre, Kanagawa, Japan.'}, {'ForeName': 'Keun-Wook', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Division of Haematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Gastroenterology, Saitama Cancer Centre, Saitama, Japan.'}, {'ForeName': 'Ik-Joo', 'Initials': 'IJ', 'LastName': 'Chung', 'Affiliation': 'Department of Haematology-Oncology, Chonnam National University Hwasun Hospital, Chonnam National University College of Medicine, Hwasun, South Korea.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Tsuda', 'Affiliation': 'Department of Gastroenterological Oncology, Hyogo Cancer Centre, Hyogo, Japan.'}, {'ForeName': 'Se Hoon', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Department of Medicine, Division of Haematology-Oncology, Samsung Medical Centre, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Hosaka', 'Affiliation': 'Department of Gastroenterology, Gunma Prefectural Cancer Centre, Gunma, Japan.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Hironaka', 'Affiliation': 'Clinical Trial Promotion Department, Chiba Cancer Centre, Chiba, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Miyata', 'Affiliation': 'Department of Medical Oncology, Saku Central Hospital Advanced Care Centre, Nagano, Japan.'}, {'ForeName': 'Min-Hee', 'Initials': 'MH', 'LastName': 'Ryu', 'Affiliation': 'Department of Oncology, Asan Medical Centre, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Baba', 'Affiliation': 'Department of Gastroenterological Surgery, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Department of Gastroenterology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Yung-Jue', 'Initials': 'YJ', 'LastName': 'Bang', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Division of Gastrointestinal Medical Oncology, National Cancer Centre Hospital, Tokyo, Japan. Electronic address: nboku@ncc.go.jp.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30315-6']
1489,32689839,Inspiratory Muscle Training Potentiates the Beneficial Effects of Proportional Assisted Ventilation on Exertional Dyspnea and Exercise Tolerance in COPD: A Proof-of-Concept Randomized and Controlled Trial.,"During pulmonary rehabilitation, a subset of subjects with COPD requires adjunct therapy to achieve high-intensity training. Both noninvasive ventilation (NIV) and inspiratory muscle training (IMT) are available to assist these subjects. We aimed to prime the respiratory muscles before NIV with IMT, anticipating additive effects for maximal exercise tolerance ( T   lim ) and dyspnea/leg fatigue relief throughout the exercise as primary outcomes. Changes in the respiratory pattern were secondary outcomes. COPD subjects performed a total of four identical constant work rate tests on a cycle ergometer at 75% of maximum work rate, under control ventilation (SHAM, 4 cm H 2 O) or proportional assisted ventilation (PAV, individually adjusted), before and after 10 sessions of high-intensity IMT (three times/week) during 30 days. Two-way RM ANOVA with appropriate corrections were performed. Final analysis in nine subjects showed improved  T   lim  (Δ = 111 s) and lower minute-ventilation (Δ = 4 L . min -1 ) at exhaustion, when comparing the IMT effects within the PAV modality ( p =  0.001 and  p =  0.036, respectively) and improved  T   lim  for PAV  vs.  SHAM (PAV main-effect,  p  = 0.001; IMT main-effect,  p  = 0.006; PAV  vs.  IMT interaction,  p  = 0.034). In addition, IMT + PAV association, compared to PAV alone, resulted in lower respiratory frequency (IMT main-effect,  p  = 0.009; time main-effect,  p  < 0.0001; IMT  vs.  time interaction,  p  = 0.242) and lower inspiratory time related to duty cycle (IMT main-effect,  p  = 0.018; time main-effect,  p  = 0.0001; IMT  vs.  time interaction,  p  = 0.004) throughout exercise. The addition of IMT prior to a PAV-supported aerobic bout potentiates exercise tolerance and dyspnea relief and induces favourable changes in ventilatory pattern in severe COPD during high-intensity training ( Brazilian Registry of Clinical Trials ,  number  RBR-6n3dzz).",2020,"min -1 ) at exhaustion, when comparing the IMT effects within the PAV modality ( p =  0.001 and  p =  0.036, respectively) and improved  T   lim  for PAV  vs.  SHAM","['COPD subjects', 'COPD']","['control ventilation (SHAM, 4\u2009cm H 2 O) or proportional assisted ventilation', 'SHAM', 'noninvasive ventilation (NIV) and inspiratory muscle training (IMT', 'Proportional Assisted Ventilation', 'Inspiratory Muscle Training', 'IMT']","['lower minute-ventilation', 'Exertional Dyspnea and Exercise Tolerance', 'maximal exercise tolerance ( T   lim ) and dyspnea/leg fatigue relief', 'lower inspiratory time related to duty cycle (IMT main-effect']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0419011', 'cui_str': 'Controlled ventilation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C3178855', 'cui_str': 'Proportional Assist Ventilation'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0231807', 'cui_str': 'Dyspnea on exertion'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0449205', 'cui_str': 'LIM'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0428686', 'cui_str': 'Inspiratory time'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0682771,"min -1 ) at exhaustion, when comparing the IMT effects within the PAV modality ( p =  0.001 and  p =  0.036, respectively) and improved  T   lim  for PAV  vs.  SHAM","[{'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Koch', 'Affiliation': 'Laboratory of Respiratory Pathophysiology (LAFIR), Maria Aparecida Pedrossian Universitary Hospital (HUMAP), Campo Grande, Mato Grosso do Sul, Brazil.'}, {'ForeName': 'Tiago Rodrigues de Lemos', 'Initials': 'TRL', 'LastName': 'Augusto', 'Affiliation': 'Laboratory of Respiratory Pathophysiology (LAFIR), Maria Aparecida Pedrossian Universitary Hospital (HUMAP), Campo Grande, Mato Grosso do Sul, Brazil.'}, {'ForeName': 'Alessandro Gomes', 'Initials': 'AG', 'LastName': 'Ramos', 'Affiliation': 'Laboratory of Respiratory Pathophysiology (LAFIR), Maria Aparecida Pedrossian Universitary Hospital (HUMAP), Campo Grande, Mato Grosso do Sul, Brazil.'}, {'ForeName': 'Paulo de Tarso', 'Initials': 'PT', 'LastName': 'Müller', 'Affiliation': 'Laboratory of Respiratory Pathophysiology (LAFIR), Maria Aparecida Pedrossian Universitary Hospital (HUMAP), Campo Grande, Mato Grosso do Sul, Brazil.'}]",COPD,['10.1080/15412555.2020.1789085']
1490,32695314,Effect of supraneural transforaminal epidural steroid injection combined with caudal epidural steroid injection with catheter in chronic radicular pain management: Double blinded randomized controlled trial.,"Background:  Epidural steroid injection (ESI) has been used in managing chronic radicular pain. Regarding various techniques of ESI, the synergistic effect of caudal ESI (CESI) on transforaminal ESI (TFESI) in chronic lumbosacral radicular pain in prospective randomized controlled trial has not been determined.   Methods :  A total of 54 eligible patients with lumbosacral radicular pain were randomly allocated to undergo TFESI plus CESI (TC group) or TFESI alone (T group).  The effective response to treatment was predefined by at least a 30% reduced verbal numerical rating scale (VNRS) from baseline between group comparison and the functional outcomes as measured by improved Oswestry Disability Index by least 15 points from baseline. All participants were evaluated using a single blinded outcome assessor before the  procedure and at 1, 3 and 6 months after the procedure. P <0.05 was considered as statistically significant.   Results :  Average VNRS reduced significantly from baseline after receiving procedure at 1, 3 and 6 months in both groups (P-value <0.05). The TC group exhibited more effective and showed significant pain relief compared with the T group at 3 months (P=0.01). However, no statistical difference was observed between sub group analysis in pain relief and insignificant difference between group comparisons of functional outcomes.  Conclusions : A treatment combining TFESI and CESI showed significant pain relief over TFESI alone at 3 months. No effect was found concerning functional evaluation.  Registration:  Thai Clinical Trials Registry ID TCTR20171101002 01/11/2017F.",2020,A treatment combining TFESI and CESI showed significant pain relief over TFESI alone in spondylolithesis and failed back surgery syndrome at 1 month.,"['chronic radicular pain management', 'chronic lumbosacral radicular pain', '54 eligible patients with lumbosacral radicular pain']","['Epidural steroid injection (ESI', 'TC', 'TFESI and CESI', 'caudal ESI (CESI', 'TFESI plus CESI (TC group) or TFESI alone (T group', 'supraneural transforaminal epidural steroid injection combined with caudal epidural steroid injection with catheter', 'transforaminal ESI (TFESI']","['Average VNRS', 'Oswestry Disability Index', 'pain relief', 'verbal numerical rating scale (VNRS']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0278147', 'cui_str': 'Radicular pain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0450206', 'cui_str': 'Lumbosacral'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0196394', 'cui_str': 'Epidural steroid injection'}, {'cui': 'C0142580', 'cui_str': 'PI3 protein, human'}, {'cui': 'C0205097', 'cui_str': 'Caudal'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036669', 'cui_str': 'Group T'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0394837', 'cui_str': 'Local anesthetic sacral epidural block'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}]","[{'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",54.0,0.143353,A treatment combining TFESI and CESI showed significant pain relief over TFESI alone in spondylolithesis and failed back surgery syndrome at 1 month.,"[{'ForeName': 'Sithapan', 'Initials': 'S', 'LastName': 'Munjupong', 'Affiliation': 'Department of Anaesthesiology, Phramongkutklao Hospital and College of Medicine, Bangkok, Bangkok, 10400, Thailand.'}, {'ForeName': 'Wipoo', 'Initials': 'W', 'LastName': 'Kumnerddee', 'Affiliation': 'Department of Rehabilitation Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Bangkok, 10400, Thailand.'}]",F1000Research,['10.12688/f1000research.23188.2']
1491,32668823,Effects of α-tocopherol on hemolysis and oxidative stress markers on red blood cells in β-thalassemia major.,"BACKGROUND


The accumulation of unpaired α-globin chains in patients with β-thalassemia major may clinically create ineffective erythropoiesis, hemolysis, and chronic anemia. Multiple blood transfusions and iron overload cause cellular oxidative damage. However, α-tocopherol, an antioxidant, is a potent scavenger of lipid radicals in the membranes of red blood cells (RBCs) of patients with β-thalassemia major.
PURPOSE


To evaluate the effects of α-tocopherol on hemolysis and oxidative stress markers on the RBC membranes of patients with β-thalassemia major.
METHODS


Forty subjects included in this randomized controlled trial were allocated to the placebo and α-tocopherol groups. Doses of α-tocopherol were based on Institute of Medicine recommendations: 4-8 years old, 200 mg/day; 9-13 years old, 400 mg/day; 14-18 years old, 600 mg/day. Hemolysis, oxidative stress, and antioxidant variables were evaluated before and after 4-week α-tocopherol or placebo treatment, performed before blood transfusions.
RESULTS


Significant enhancements in plasma haptoglobin were noted in the α-tocopherol group (3.01 mg/dL; range, 0.60-42.42 mg/dL; P=0.021). However, there was no significant intergroup difference in osmotic fragility test results; hemopexin, malondialdehyde, reduced glutathione (GSH), or oxidized glutathione (GSSG) levels; or GSH/GSSG ratio.
CONCLUSION


Use of α-tocopherol could indirectly improve hemolysis and haptoglobin levels. However, it played no significant role in oxidative stress or as an endogen antioxidant marker in β-thalassemia major.",2020,"Results


Significant enhancements in plasma haptoglobin were noted in the α-tocopherol group (3.01 mg/dL; range, 0.60-42.42 mg/dL; P=0.021).","['Methods\n\n\nForty subjects', 'β-thalassemia major', 'patients with β-thalassemia major']","['α-tocopherol or placebo', 'placebo and α-tocopherol', 'α-tocopherol']","['hemolysis and haptoglobin levels', 'oxidative stress', 'Hemolysis, oxidative stress, and antioxidant variables', 'plasma haptoglobin', 'osmotic fragility test results; hemopexin, malondialdehyde, reduced glutathione (GSH), or oxidized glutathione (GSSG) levels; or GSH/GSSG ratio']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0002875', 'cui_str': 'Homozygous beta thalassemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019054', 'cui_str': 'Haemolysis'}, {'cui': 'C0018595', 'cui_str': 'Haptoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0029392', 'cui_str': 'Osmotic fragility'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0019067', 'cui_str': 'Hemopexin'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}, {'cui': 'C0061516', 'cui_str': 'Glutathione Disulfide'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",40.0,0.0385745,"Results


Significant enhancements in plasma haptoglobin were noted in the α-tocopherol group (3.01 mg/dL; range, 0.60-42.42 mg/dL; P=0.021).","[{'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Sovira', 'Affiliation': 'Division of Pediatric Emergency & Intensive Care, Department of Pediatrics, Faculty of Medicine, University of Syiah Kualal/Dr. Zainoel Abidin Hospital, Banda Aceh, Indonesia.'}, {'ForeName': 'Munar', 'Initials': 'M', 'LastName': 'Lubis', 'Affiliation': 'Division of Pediatric Emergency & Intensive Care, Department of Pediatrics, Faculty of Medicine, University of Sumatera Utara/University of Sumatera Utara Hospital, Medan, Indonesia.'}, {'ForeName': 'Pustika Amalia', 'Initials': 'PA', 'LastName': 'Wahidiyat', 'Affiliation': 'Division of Hematology Oncology, Department of Pediatrics, Faculty of Medicine, University of Indonesia/Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Franciscus D', 'Initials': 'FD', 'LastName': 'Suyatna', 'Affiliation': 'Department of Pharmacology and Therapeutics, Faculty of Medicine, University of Indonesia/Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Djajadiman', 'Initials': 'D', 'LastName': 'Gatot', 'Affiliation': 'Division of Hematology Oncology, Department of Pediatrics, Faculty of Medicine, University of Indonesia/Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Saptawati', 'Initials': 'S', 'LastName': 'Bardosono', 'Affiliation': 'Department of Nutrition, Faculty of Medicine, University of Indonesia/Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sadikin', 'Affiliation': 'Department of Biochemistry and Molecular Biology, Faculty of Medicine, University of Indonesia/Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}]",Clinical and experimental pediatrics,['10.3345/cep.2019.00542']
1492,32676134,"Effectiveness of Acupuncture Treatment on Chemotherapy-Induced Peripheral Neuropathy: A Pilot, Randomized, Assessor-Blinded, Controlled Trial.","Objective


This pilot study aims to evaluate the effectiveness and safety of acupuncture in the treatment of chemotherapy-induced peripheral neuropathy (CIPN).
Methods


This study was a pilot randomized controlled trial, which was conducted with cooperation between Beijing University of Chinese Medicine (BUCM), China, and Tehran University of Medical Science (TUMS), Iran. Forty participants with CIPN were randomly assigned (1 : 1) to receive twelve sessions of acupuncture (20 minutes each session over 4 weeks) or take one 300 mg tablet of vitamin B1 and three 300 mg capsules of gabapentin per day for 4 weeks, after which both groups were followed up for 4 weeks. The primary endpoint was CIPN symptom severity measured by the Numerical Rating Scale (NRS). The secondary endpoints included sensory neuropathy grade evaluated by the National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE), neurophysiological assessment of CIPN by the nerve conduction study (NCS), and the patient overall satisfaction with treatment. Safety was assessed at each visit.
Results


The NRS and NCI-CTCAE sensory neuropathy grading scales decreased significantly over time in both groups (both  P  < 0.001), with a significantly higher reduction in the acupuncture group ( P  < 0.001 and  P  = 0.03, respectively). In addition, the acupuncture group showed a higher overall satisfaction with the treatment at the end of treatment and after 4 weeks follow-up, in comparison with the vit B1 and gabapentin group ( P  = 0.01 and  P  = 0.001, respectively). The NCS (except for the latency of the sural nerve) in the acupuncture group improved significantly ( P  < 0.05), while improvement in the vit B1 and gabapentin group was not observed ( P  > 0.05).
Conclusion


Our study revealed that acupuncture, as a kind of traditional Chinese therapeutic method, is significantly effective and safe in the treatment of CIPN. Moreover, acupuncture is more effective than using vitamin B1 and gabapentin as the conventional treatment.  Trial registration.  This trial is registered with the Iranian Registry of Clinical Trials (IRCT20190615043900N1).",2020,"The NCS (except for the latency of the sural nerve) in the acupuncture group improved significantly ( P  < 0.05), while improvement in the vit B1 and gabapentin group was not observed ( P  > 0.05).
","['Chemotherapy-Induced Peripheral Neuropathy', 'Forty participants with CIPN', 'cooperation between Beijing University of Chinese Medicine (BUCM), China, and Tehran University of Medical Science']","['acupuncture', 'vitamin B1 and gabapentin', 'gabapentin', 'vit B1 and gabapentin', 'Acupuncture', 'vitamin B1 and three 300\u2009mg capsules of gabapentin']","['CIPN symptom severity measured by the Numerical Rating Scale (NRS', 'Safety', 'overall satisfaction', 'NRS and NCI-CTCAE sensory neuropathy grading scales', 'effectiveness and safety', 'sensory neuropathy grade evaluated by the National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE), neurophysiological assessment of CIPN by the nerve conduction study (NCS), and the patient overall satisfaction with treatment']","[{'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0200125', 'cui_str': 'Nerve conduction study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",40.0,0.246775,"The NCS (except for the latency of the sural nerve) in the acupuncture group improved significantly ( P  < 0.05), while improvement in the vit B1 and gabapentin group was not observed ( P  > 0.05).
","[{'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Iravani', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing 100029, China.'}, {'ForeName': 'Amir Hooman', 'Initials': 'AH', 'LastName': 'Kazemi Motlagh', 'Affiliation': 'School of Persian Medicine, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Seyede Zahra', 'Initials': 'SZ', 'LastName': 'Emami Razavi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Imam Khomeini Hospital Complex, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Shahi', 'Affiliation': 'Department of Hematology and Medical Oncology, Imam Khomeini Hospital Complex, Cancer Institute Research Center, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology and Oncology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Hou', 'Affiliation': 'Department of Hematology and Oncology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, 3 Affiliated Hospital, Beijing University of Chinese Medicine, Beijing 100029, China.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Afshari Fard', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing 100029, China.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Aghili', 'Affiliation': 'Department of Radiation Oncology, Radiation Oncology Research Center, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Karimi', 'Affiliation': 'School of Persian Medicine, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Rezaeizadeh', 'Affiliation': 'School of Persian Medicine, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Baixiao', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China.'}]",Pain research & management,['10.1155/2020/2504674']
1493,32676136,Postendodontic Pain after Pulpotomy or Root Canal Treatment in Mature Teeth with Carious Pulp Exposure: A Multicenter Randomized Controlled Trial.,"This equivalence, randomized, clinical trial aimed to compare the postoperative pain of root canal therapy (RCT) with pulpotomy with mineral trioxide aggregate (PMTA) or calcium-enriched mixture (PCEM) in permanent mature teeth. In seven academic centers, 550 cariously exposed pulps were included and randomly allocated into PMTA ( n  = 188), PCEM ( n  = 194), or RCT ( n  = 168) arms. Preoperative ""Pain Intensity"" (PI) on Numerical Rating Scale and postoperative PIs until day 7 were recorded. Patients' demographic and pre-/intra-/postoperative factors/conditions were recorded/analysed. The arms were homogeneous in terms of demographics. The mean preoperative PIs were similar ( P =0.998), the mean sum PIs recorded during 10 postoperative intervals were comparable ( P =0.939), and the trend/changes in pain relief were parallel ( P =0.821) in all study arms. The incidences of preoperative moderate-severe pain in RCT, PMTA, and PCEM arms were 56.5%, 55.7%, and 56.7%, which after 24 hours considerably decreased to 13.1%, 10.6%, and 12.9%, respectively ( P =0.578). The time span of endodontic procedures was statistically different; RCT = 69.73, PMTA = 35.37, and PCEM = 33.62 minutes ( P  < 0.001). Patients with greater preoperative pain, symptomatic apical periodontitis, or presence of PDL widening suffered more pain ( P =0.002, 0.035, and 0.023, resp.); however, other pre-/intra-/postoperative factors/conditions were comparable. Pulpotomy with MTA/CEM and RCT demonstrate comparable and effective postoperative pain relief.",2020,"The mean preoperative PIs were similar ( P =0.998), the mean sum PIs recorded during 10 postoperative intervals were comparable ( P =0.939), and the trend/changes in pain relief were parallel ( P =0.821) in all study arms.","['In seven academic centers, 550 cariously exposed pulps', 'permanent mature teeth', 'Mature Teeth with Carious Pulp Exposure']","['RCT', 'root canal therapy (RCT) with pulpotomy with mineral trioxide aggregate (PMTA) or calcium-enriched mixture (PCEM', 'PMTA', 'PCEM', 'Pulpotomy or Root Canal Treatment', 'MTA/CEM and RCT']","['Postendodontic Pain', 'mean preoperative PIs', 'pain relief', 'effective postoperative pain relief', 'time span of endodontic procedures', 'mean sum PIs', 'incidences of preoperative moderate-severe pain', 'Preoperative ""Pain Intensity"" (PI) on Numerical Rating Scale and postoperative PIs', 'preoperative pain, symptomatic apical periodontitis', 'pain']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}, {'cui': 'C0253527', 'cui_str': 'mineral trioxide aggregate'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0378574', 'cui_str': '2-chloroethyl methyl sulfide'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0031030', 'cui_str': 'Apical periodontitis'}]",,0.121584,"The mean preoperative PIs were similar ( P =0.998), the mean sum PIs recorded during 10 postoperative intervals were comparable ( P =0.939), and the trend/changes in pain relief were parallel ( P =0.821) in all study arms.","[{'ForeName': 'Mohammad Jafar', 'Initials': 'MJ', 'LastName': 'Eghbal', 'Affiliation': 'Iranian Center for Endodontic Research, Research Institute for Dental Sciences, Shahid Beheshti University of Medical Sciences, Tehran 1983963113, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Haeri', 'Affiliation': 'Iranian Center for Endodontic Research, Research Institute for Dental Sciences, Shahid Beheshti University of Medical Sciences, Tehran 1983963113, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Shahravan', 'Affiliation': 'Endodontology Research Center, Endodontic Department, Dental School, Kerman University of Medical Sciences, Kerman 7618751689, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Kazemi', 'Affiliation': 'Endodontic Department, Dental School, Shahed University, Tehran 1417755351, Iran.'}, {'ForeName': 'Fariborz', 'Initials': 'F', 'LastName': 'Moazami', 'Affiliation': 'Endodontic Department, Dental School, Shiraz University of Medical Science, Shiraz 7134814336, Iran.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Mozayeni', 'Affiliation': 'Endodontic Department, Dental School, Shahid Beheshti University of Medical Sciences, Tehran 1983963113, Iran.'}, {'ForeName': 'Eshaghali', 'Initials': 'E', 'LastName': 'Saberi', 'Affiliation': 'Endodontic Department, Oral and Dental Diseases Research Center, Dental School, Zahedan University of Medical Sciences, Zahedan 9816743463, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Samiei', 'Affiliation': 'Endodontic Department, Dental School, Tabriz University of Medical Sciences, Tabriz 5166614713, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Vatanpour', 'Affiliation': 'Endodontic Department, Dental Branch, Islamic Azad University, Tehran 1946853314, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Akbarzade Baghban', 'Affiliation': 'Department of Basic Sciences, Proteomics Research Center, School of Rehabilitation, Shahid Beheshti University of Medical Sciences, Tehran 1616913111, Iran.'}, {'ForeName': 'Mahta', 'Initials': 'M', 'LastName': 'Fazlyab', 'Affiliation': 'Endodontic Department, Dental Branch, Islamic Azad University, Tehran 1946853314, Iran.'}, {'ForeName': 'Ardavan', 'Initials': 'A', 'LastName': 'Parhizkar', 'Affiliation': 'Iranian Center for Endodontic Research, Research Institute for Dental Sciences, Shahid Beheshti University of Medical Sciences, Tehran 1983963113, Iran.'}, {'ForeName': 'Mahboobe', 'Initials': 'M', 'LastName': 'Ahmadi', 'Affiliation': 'Endodontic Department, Oral and Dental Diseases Research Center, Dental School, Zahedan University of Medical Sciences, Zahedan 9816743463, Iran.'}, {'ForeName': 'Nazila', 'Initials': 'N', 'LastName': 'Akbarian Rad', 'Affiliation': 'Endodontic Department, Dental School, Shahid Beheshti University of Medical Sciences, Tehran 1983963113, Iran.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Bijari', 'Affiliation': 'Endodontic Department, Oral and Dental Diseases Research Center, Dental School, Zahedan University of Medical Sciences, Zahedan 9816743463, Iran.'}, {'ForeName': 'Delaram', 'Initials': 'D', 'LastName': 'Bineshmarvasti', 'Affiliation': 'Endodontic Department, Dental Branch, Islamic Azad University, Tehran 1946853314, Iran.'}, {'ForeName': 'Paria', 'Initials': 'P', 'LastName': 'Davoudi', 'Affiliation': 'Endodontic Department, Dental School, Tabriz University of Medical Sciences, Tabriz 5166614713, Iran.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Dehghan', 'Affiliation': 'Endodontic Department, Dental School, Shiraz University of Medical Science, Shiraz 7134814336, Iran.'}, {'ForeName': 'Mandana', 'Initials': 'M', 'LastName': 'Dehghani', 'Affiliation': 'Endodontic Department, Dental School, Shiraz University of Medical Science, Shiraz 7134814336, Iran.'}, {'ForeName': 'Habibollah', 'Initials': 'H', 'LastName': 'Ebrahimi', 'Affiliation': 'Endodontic Department, Oral and Dental Diseases Research Center, Dental School, Zahedan University of Medical Sciences, Zahedan 9816743463, Iran.'}, {'ForeName': 'Nafiseh', 'Initials': 'N', 'LastName': 'Emami', 'Affiliation': 'Endodontic Department, Dental Branch, Islamic Azad University, Tehran 1946853314, Iran.'}, {'ForeName': 'Nafiseh', 'Initials': 'N', 'LastName': 'Farajian', 'Affiliation': 'Endodontic Department, Dental School, Shahed University, Tehran 1417755351, Iran.'}, {'ForeName': 'Rahim', 'Initials': 'R', 'LastName': 'Fereidooni', 'Affiliation': 'Endodontology Research Center, Endodontic Department, Dental School, Kerman University of Medical Sciences, Kerman 7618751689, Iran.'}, {'ForeName': 'Gelareh', 'Initials': 'G', 'LastName': 'Ghobadi', 'Affiliation': 'Endodontic Department, Dental Branch, Islamic Azad University, Tehran 1946853314, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Ghodrati', 'Affiliation': 'Endodontic Department, Dental School, Tabriz University of Medical Sciences, Tabriz 5166614713, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Gohari', 'Affiliation': 'Endodontic Department, Dental School, Shahid Beheshti University of Medical Sciences, Tehran 1983963113, Iran.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Hashemi', 'Affiliation': 'Endodontology Research Center, Endodontic Department, Dental School, Kerman University of Medical Sciences, Kerman 7618751689, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Hosseini', 'Affiliation': 'Endodontic Department, Dental School, Shahid Beheshti University of Medical Sciences, Tehran 1983963113, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Karami', 'Affiliation': 'Endodontic Department, Dental School, Shiraz University of Medical Science, Shiraz 7134814336, Iran.'}, {'ForeName': 'Nasir', 'Initials': 'N', 'LastName': 'Kheirabadi', 'Affiliation': 'Endodontology Research Center, Endodontic Department, Dental School, Kerman University of Medical Sciences, Kerman 7618751689, Iran.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Kozegari', 'Affiliation': 'Endodontic Department, Dental School, Tabriz University of Medical Sciences, Tabriz 5166614713, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Labaf Ghasemi', 'Affiliation': 'Endodontic Department, Dental Branch, Islamic Azad University, Tehran 1946853314, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Majidi', 'Affiliation': 'Endodontic Department, Dental School, Tabriz University of Medical Sciences, Tabriz 5166614713, Iran.'}, {'ForeName': 'Parastu', 'Initials': 'P', 'LastName': 'Malekzadeh', 'Affiliation': 'Endodontic Department, Dental School, Shiraz University of Medical Science, Shiraz 7134814336, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Mehrabi', 'Affiliation': 'Endodontic Department, Dental School, Shiraz University of Medical Science, Shiraz 7134814336, Iran.'}, {'ForeName': 'Mehrnush', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Endodontic Department, Dental School, Tabriz University of Medical Sciences, Tabriz 5166614713, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Moradi Eslami', 'Affiliation': 'Endodontic Department, Dental Branch, Islamic Azad University, Tehran 1946853314, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Noghani', 'Affiliation': 'Endodontic Department, Dental School, Tabriz University of Medical Sciences, Tabriz 5166614713, Iran.'}, {'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Omatali', 'Affiliation': 'Endodontic Department, Dental Branch, Islamic Azad University, Tehran 1946853314, Iran.'}, {'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Pourhatami', 'Affiliation': 'Endodontic Department, Dental School, Shiraz University of Medical Science, Shiraz 7134814336, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Rahbani Nobar', 'Affiliation': 'Endodontic Department, Dental School, Shahid Beheshti University of Medical Sciences, Tehran 1983963113, Iran.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Rahmani', 'Affiliation': 'Endodontology Research Center, Endodontic Department, Dental School, Kerman University of Medical Sciences, Kerman 7618751689, Iran.'}, {'ForeName': 'Parviz', 'Initials': 'P', 'LastName': 'Shafaq', 'Affiliation': 'Endodontic Department, Dental School, Shahid Beheshti University of Medical Sciences, Tehran 1983963113, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Soofiabadi', 'Affiliation': 'Endodontology Research Center, Endodontic Department, Dental School, Kerman University of Medical Sciences, Kerman 7618751689, Iran.'}, {'ForeName': 'Somaye', 'Initials': 'S', 'LastName': 'Teimoori', 'Affiliation': 'Endodontic Department, Dental School, Shahed University, Tehran 1417755351, Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Vatandoost', 'Affiliation': 'Endodontic Department, Dental School, Shahid Beheshti University of Medical Sciences, Tehran 1983963113, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Asgary', 'Affiliation': 'Iranian Center for Endodontic Research, Research Institute for Dental Sciences, Shahid Beheshti University of Medical Sciences, Tehran 1983963113, Iran.'}]",Pain research & management,['10.1155/2020/5853412']
1494,32678299,The influence of foot and back massage on blood pressure and sleep quality in females with essential hypertension: a randomized controlled study.,"The present study was conducted with the aim of investigating the influence of foot and back massage on blood pressure and sleep quality in females with essential hypertension. Non-pharmacologic methods like massage may be effective for balancing blood pressure and solving sleep problems. This is a randomized controlled study conducted in accordance with CONSORT rules. Females with essential hypertension were applied a total of six sessions of 30 min of foot and back massage twice weekly during 3 weeks. The study included a total of 90 patients of whom 60 were in intervention group (foot massage group, back massage group) and 30 in control group. Data were collected through personal data form (PDF) which included descriptive characteristics, Pittsburgh Sleep Quality Index (PSQI). Six sessions of foot massage and back massage were detected to lead to a reduction in systolic blood pressure (SBP) and diastolic blood pressure (DBP) values and the difference was statistically significant (p < 0.001). A strong statistical difference was found between mean pretest posttest scores of overall and sub-dimensional scores of PSQI in females in intervention group (p < 0.001). Foot and back massage was found to be effective in reducing blood pressure and improving sleep quality.",2020,A strong statistical difference was found between mean pretest posttest scores of overall and sub-dimensional scores of PSQI in females in intervention group (p < 0.001).,"['Females with essential hypertension', '90 patients of whom 60 were in', 'females with essential hypertension']","['foot and back massage', 'intervention group (foot massage group, back massage group) and 30 in control group']","['blood pressure and sleep quality', 'blood pressure and improving sleep quality', 'systolic blood pressure (SBP) and diastolic blood pressure (DBP) values', 'Pittsburgh Sleep Quality Index (PSQI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}]",90.0,0.0242063,A strong statistical difference was found between mean pretest posttest scores of overall and sub-dimensional scores of PSQI in females in intervention group (p < 0.001).,"[{'ForeName': 'Gürcan', 'Initials': 'G', 'LastName': 'Arslan', 'Affiliation': 'Department of Internal Diseases Nursing, Faculty of Health Sciences, Sivas Cumhuriyet University, Sivas, Turkey. gurcansolmaz@hotmail.com.'}, {'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Ceyhan', 'Affiliation': 'Department of Internal Diseases Nursing, Faculty of Health Sciences, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Mukadder', 'Initials': 'M', 'LastName': 'Mollaoğlu', 'Affiliation': 'Department of Internal Diseases Nursing, Faculty of Health Sciences, Sivas Cumhuriyet University, Sivas, Turkey.'}]",Journal of human hypertension,['10.1038/s41371-020-0371-z']
1495,32674036,Effects of a nurse-led medication self-management programme in women with oral treatments for metastatic breast cancer: A mixed-method randomised controlled trial.,"PURPOSE


Adherence to medication is the most important challenge facing patients receiving oral anticancer treatment. This study aimed to evaluate the effects of a patient-centred medication self-management support programme in patients with metastatic breast cancer undergoing oral anticancer treatment.
METHODS


This trial was a two-phased mixed-method randomised controlled study. Eligible participants were 155 patients with metastatic breast cancer newly prescribed an oral chemotherapy or targeted therapy agent. The intervention group received the patient-centred medication self-management support programme conducted by trained nurses. Primary outcome was adherence to medication at three months after the commencement of treatment, calculated by medication possession ratio (MPR). Secondary outcomes included self-efficacy, functional assessment, psychological distress, symptom severity and symptom interference, and patient satisfaction. After the completion of the intervention study, focus group interviews were conducted among intervention nurses.
RESULTS


Both intervention and control groups maintained more than 90% of MPR and no significant difference was observed in the primary outcome. Regarding secondary outcomes, only general self-efficacy was significantly different in the two groups. In the qualitative study, the intervention nurses perceived improvement in the patients' self-efficacy, ability to anticipate the impact of treatment and adjust to life, and avoidance of loneliness.
CONCLUSIONS


A significant effect of the programme was not found in the program because the adherence rate was high in both groups. Improvement in the patients' self-efficacy was observed both quantitatively and qualitatively.
TRIAL REGISTRATION


UMIN Clinical Trials Registry (UMIN-CTR), Japan, UMIN000016597. (27 February 2015).",2020,Both intervention and control groups maintained more than 90% of MPR and no significant difference was observed in the primary outcome.,"['patients receiving oral anticancer treatment', 'Eligible participants were 155 patients with metastatic breast cancer newly prescribed an oral chemotherapy or targeted therapy agent', 'patients with metastatic breast cancer undergoing oral anticancer treatment', 'women with oral treatments for metastatic breast cancer']","['patient-centred medication self-management support programme', 'patient-centred medication self-management support programme conducted by trained nurses', 'nurse-led medication self-management programme']","['self-efficacy, functional assessment, psychological distress, symptom severity and symptom interference, and patient satisfaction', 'adherence to medication', 'adherence rate', 'medication possession ratio (MPR', 'general self-efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0419073', 'cui_str': 'Oral chemotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0036600', 'cui_str': 'Self-medication'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",155.0,0.0763852,Both intervention and control groups maintained more than 90% of MPR and no significant difference was observed in the primary outcome.,"[{'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Komatsu', 'Affiliation': 'Japanese Red Cross Kyushu International College of Nursing, 1-1 Asty Munakata-City, Fukuoka-Prefecture, 811-4157, Japan. Electronic address: h-komatsu@jrckicn.ac.jp.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Yagasaki', 'Affiliation': 'Faculty of Nursing and Medical Care, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan. Electronic address: yagasaki@sfc.keio.ac.jp.'}, {'ForeName': 'Takuhiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Biostatistics, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan. Electronic address: yamaguchi@med.tohoku.ac.jp.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Mori', 'Affiliation': 'Division of Nursing, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. Electronic address: aymori@ncc.go.jp.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Kawano', 'Affiliation': 'Nursing Department, Kanagawa Cancer Center, 2-3-1 Nakao, Yokohamashi, Kanagawa, 241-8515, Japan. Electronic address: gairai@kcch.jp.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Minamoto', 'Affiliation': 'Nursing Division, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa-shi, Chiba-ken, 277-8577, Japan. Electronic address: nminamot@east.ncc.go.jp.'}, {'ForeName': 'Orie', 'Initials': 'O', 'LastName': 'Honma', 'Affiliation': 'Division of Nursing, Showa University Hospital, 1-5-8, Hatanodai, Shinagawaku, Tokyo, 142-8666, Japan. Electronic address: ori-miya20@cmed.showa-u.ac.jp.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'Department of Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. Electronic address: ketamura@ncc.go.jp.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2020.101780']
1496,32674048,"Cyclosporine or methotrexate, which one is more promising in the treatment of lichen planopilaris?; A comparative clinical trial.","BACKGROUND


Lichen Planopilaris (LPP) is a primary scarring alopecia with unknown etiology and its management is a challenge for dermatologists. We aimed to compare the safety and efficacy of methotrexate and cyclosporine in LPP patients.
METHODS


In a randomized clinical trials, 33 patients were randomly allocated to receive either 15-mg oral methotrexate per week or 3-5-mg/kg/day cyclosporine for six months. During the treatment course, side effects, signs/symptoms and laboratory test were assessed periodically. Lichen planopilaris activity index (LPPAI) was measured at baseline and 2, 4, and 6 months after the intervention. Score of both photography and patient's opinion were also obtained. The collected data were analyzed in SPSS software (Ver.25.0. Armonk, NY: IBM Corp).
RESULTS


Both medications had positive effects on the signs and symptoms of LPP with a significant difference between the variables (p < 0.05), and the results showed similar efficacy at the end of 6th months of the therapy with both cyclosporine and methotrexate (p > 0.05).
CONCLUSIONS


Regarding the results of the present study, both cyclosporine and methotrexate are effective in treating refractory lichen planopilaris and we propose methotrexate as a possible earlier choice over cyclosporine. This study was registered in Iranian Registry of Clinical Trials (IRCT20190717044256N1).",2020,"Both medications had positive effects on the signs and symptoms of LPP with a significant difference between the variables (p < 0.05), and the results showed similar efficacy at the end of 6th months of the therapy with both cyclosporine and methotrexate (p > 0.05).
","['LPP patients', '33 patients']","['Lichen Planopilaris (LPP', 'cyclosporine and methotrexate', '15-mg oral methotrexate per week or 3-5-mg/kg/day cyclosporine', 'Cyclosporine or methotrexate', 'methotrexate and cyclosporine', 'cyclosporine']","['side effects, signs/symptoms and laboratory test', 'safety and efficacy', 'Lichen planopilaris activity index (LPPAI', 'signs and symptoms of LPP']","[{'cui': 'C0023645', 'cui_str': 'Lichen planopilaris'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0023645', 'cui_str': 'Lichen planopilaris'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0023645', 'cui_str': 'Lichen planopilaris'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",33.0,0.113439,"Both medications had positive effects on the signs and symptoms of LPP with a significant difference between the variables (p < 0.05), and the results showed similar efficacy at the end of 6th months of the therapy with both cyclosporine and methotrexate (p > 0.05).
","[{'ForeName': 'Farahnaz', 'Initials': 'F', 'LastName': 'Fatemi Naeini', 'Affiliation': 'Skin Diseases and Leishmaniasis Research Center, Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: fatemi@med.mui.ac.ir.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Mohaghegh', 'Affiliation': 'Skin Diseases and Leishmaniasis Research Center, Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: f.mohaghegh@med.mui.ac.ir.'}, {'ForeName': 'Minoo', 'Initials': 'M', 'LastName': 'Jelvan', 'Affiliation': 'Skin Diseases and Leishmaniasis Research Center, Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: minoo.jelvan@gmail.com.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Asilian', 'Affiliation': 'Skin Diseases and Leishmaniasis Research Center, Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: asilian@med.mui.ac.ir.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Saber', 'Affiliation': 'Skin Diseases and Leishmaniasis Research Center, Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: mi.saber@med.mui.ac.ir.'}]",International immunopharmacology,['10.1016/j.intimp.2020.106765']
1497,32673261,"Evidence-Based Decision Aid for Patients With Parkinson Disease: Protocol for Interview Study, Online Survey, and Two Randomized Controlled Trials.","BACKGROUND


Shared decision making is particularly important in situations with different treatment alternatives. For the treatment of idiopathic Parkinson disease, both pharmacological and surgical approaches can be applied.
OBJECTIVE


In this research project, a series of studies will be conducted to investigate how decision aids for patients with idiopathic Parkinson disease should be designed in order to support the decision-making process.
METHODS


In Study 1a, qualitative interviews will be conducted to determine which needs frequently occur for patients with idiopathic Parkinson disease. In Study 1b, the identified needs will then be rated for personal relevance by an independent group of patients in an online survey. In Study 2, a randomized controlled trial will be used to pretest different decision aids in a sample group of people who do not have a medical background and who do not have Parkinson disease. In Study 3, a randomized controlled trial will be used to investigate the effect of the decision aids that had been evaluated as positive in Study 2 with patients who have idiopathic Parkinson disease.
RESULTS


This series of studies received ethical approval in January 2020. As of June 2020, data collection for Study 1a has started, and it is estimated that Studies 1a, 1b, 2, and 3 will take approximately 4, 4, 6, and 6 months to complete, respectively. It is planned to present the results and analyses at international conferences and to submit the results to peer-reviewed journals for publication, once the studies have been completed. The findings will also be shared with clinicians and patients through presentations at information events.
CONCLUSIONS


This series of studies is intended to result in an evidence-based decision aid for patients with idiopathic Parkinson disease in order to support the informed and reflected shared decision-making process. We further intend to contribute to a deeper understanding of the individual preferences of patients with idiopathic Parkinson disease and the impact of those preferences on treatment decisions.",2020,"As of June 2020, data collection for Study 1a has started, and it is estimated that Studies 1a, 1b, 2, and 3 will take approximately 4, 4, 6, and 6 months to complete, respectively.","['Patients With Parkinson Disease', 'patients with idiopathic Parkinson disease', 'patients who have idiopathic Parkinson disease', 'sample group of people who do not have a medical background and who do not have Parkinson disease']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]",[],[],2.0,0.0680163,"As of June 2020, data collection for Study 1a has started, and it is estimated that Studies 1a, 1b, 2, and 3 will take approximately 4, 4, 6, and 6 months to complete, respectively.","[{'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Bientzle', 'Affiliation': 'Leibniz-Institut für Wissensmedien, Tübingen, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Kimmerle', 'Affiliation': 'Leibniz-Institut für Wissensmedien, Tübingen, Germany.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Eggeling', 'Affiliation': 'Leibniz-Institut für Wissensmedien, Tübingen, Germany.'}, {'ForeName': 'Idil', 'Initials': 'I', 'LastName': 'Cebi', 'Affiliation': 'Division of Functional and Restorative Neurosurgery and Tübingen NeuroCampus, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Weiss', 'Affiliation': 'Department of Neurodegenerative Diseases, Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Gharabaghi', 'Affiliation': 'Division of Functional and Restorative Neurosurgery and Tübingen NeuroCampus, University of Tübingen, Tübingen, Germany.'}]",JMIR research protocols,['10.2196/17482']
1498,32673262,Implementing mHealth Interventions in a Resource-Constrained Setting: Case Study From Uganda.,"BACKGROUND


Mobile health (mHealth) interventions are becoming more common in low-income countries. Existing research often overlooks implementation challenges associated with the design and technology requirements of mHealth interventions.
OBJECTIVE


We aimed to characterize the challenges that we encountered in the implementation of a complex mHealth intervention in Uganda.
METHODS


We customized a commercial mobile survey app to facilitate a two-arm household-randomized, controlled trial of home-based tuberculosis (TB) contact investigation. We incorporated digital fingerprinting for patient identification in both study arms and automated SMS messages in the intervention arm only. A local research team systematically documented challenges to implementation in biweekly site visit reports, project management reports, and minutes from biweekly conference calls. We then classified these challenges using the Consolidated Framework for Implementation Research (CFIR).
RESULTS


We identified challenges in three principal CFIR domains: (1) intervention characteristics, (2) inner setting, and (3) characteristics of implementers. The adaptability of the app to the local setting was limited by software and hardware requirements. The complexity and logistics of implementing the intervention further hindered its adaptability. Study staff reported that community health workers (CHWs) were enthusiastic regarding the use of technology to enhance TB contact investigation during training and the initial phase of implementation. After experiencing technological failures, their trust in the technology declined along with their use of it. Finally, complex data structures impeded the development and execution of a data management plan that would allow for articulation of goals and provide timely feedback to study staff, CHWs, and participants.
CONCLUSIONS


mHealth technologies have the potential to make delivery of public health interventions more direct and efficient, but we found that a lack of adaptability, excessive complexity, loss of trust among end users, and a lack of effective feedback systems can undermine implementation, especially in low-resource settings where digital services have not yet proliferated. Implementers should anticipate and strive to avoid these barriers by investing in and adapting to local human and material resources, prioritizing feedback from end users, and optimizing data management and quality assurance procedures.
TRIAL REGISTRATION


Pan-African Clinical Trials Registration PACTR201509000877140; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=877.",2020,Study staff reported that community health workers (CHWs) were enthusiastic regarding the use of technology to enhance TB contact investigation during training and the initial phase of implementation.,"['community health workers (CHWs', 'We customized a commercial mobile survey app to facilitate a two-arm household-randomized, controlled trial of home-based tuberculosis (TB) contact investigation', 'Uganda']",[],[],"[{'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]",[],[],,0.074366,Study staff reported that community health workers (CHWs) were enthusiastic regarding the use of technology to enhance TB contact investigation during training and the initial phase of implementation.,"[{'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Meyer', 'Affiliation': 'Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, United States.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Armstrong-Hough', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Babirye', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mark', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Turimumahoro', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Ayakaka', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Haberer', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Achilles', 'Initials': 'A', 'LastName': 'Katamba', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'J Lucian', 'Initials': 'JL', 'LastName': 'Davis', 'Affiliation': 'Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, United States.'}]",JMIR mHealth and uHealth,['10.2196/19552']
1499,32673265,Del Nido Cardioplegia Versus Cold Blood Cardioplegia in Adult Cardiac Surgery: Protocol for a Randomized Controlled Trial.,"BACKGROUND


The use of cardioplegia solutions as a myocardial protection technique is essential during cardiac surgery with cardiopulmonary bypass. The del Nido cardioplegia solution (DNS) has been widely used as a myocardial preservation technique for pediatric patients undergoing cardiac surgery with cardiopulmonary bypass. Its unique pharmacological features have created growing interest for adult cardiac surgery, especially for elderly patients or those with ventricular dysfunction who are more prone to ischemia-reperfusion injury. Ever since its implementation, several retrospective studies have been published to validate the efficacy, safety, and efficiency of DNS in adult patients undergoing coronary revascularization, valve replacement, or combined procedures. Recently, a meta-analysis based on nine retrospective studies was published claiming the noninferiority of DNS compared to other conventional cardioplegia solutions. Few prospective randomized studies have been conducted whose primary outcome was the assessment of DNS clinical efficacy compared to other solutions commonly used in adult patients.
OBJECTIVE


The aim of this randomized clinical trial is to assess the benefits of DNS compared to Cardi-Braun blood cardioplegia solution in clinical and biochemical terms regarding myocardial protection during adult cardiac surgery.
METHODS


This is the protocol of a controlled, randomized, single-center clinical trial carried out at the Puerta de Hierro Majadahonda University Hospital in Spain. A total of 474 participants over the age of 18 years undergoing elective cardiac surgery with cardiopulmonary bypass will be assigned to groups by simple randomization to receive either DNS or Cardi-Braun blood cardioplegia solution. The primary outcome will be the differences between groups in myocardial protection in biochemical terms (ie, perioperative troponin levels) and clinical terms (ie, presence of the composite variable acute cardiovascular event). The clinical trial will be carried out under conditions of respect for the fundamental rights of the person and the ethical principles that affect biomedical research with human beings, as well as in accordance with international recommendations contained in the Declaration of Helsinki and its subsequent revisions.
RESULTS


The inclusion process started in 2018. Data cleaning and analyses are expected to take place in the fall of 2020 and the results are expected in January 2021.
CONCLUSIONS


This study is particularly relevant as it will be one of the first to analyze the clinical effects of del Nido cardioplegia on the basis of direct myocardial protection parameters. In light of published studies, carrying out prospective studies based on primary clinical objectives with a larger sample, high-risk patients, and longer cardiopulmonary bypass times continues to be necessary. We believe that our study addresses an important gap in the knowledge of del Nido cardioplegia in adult patient cardiac surgery and will be able to clarify the possible benefits of this method in a large population of patients undergoing these procedures.
TRIAL REGISTRATION


European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) 2017-005144-14; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2017-005144-14+; ClinicalTrials.gov NCT04094168; https://clinicaltrials.gov/ct2/show/NCT04094168.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17826.",2020,The del Nido cardioplegia solution (DNS) has been widely used as a myocardial preservation technique for pediatric patients undergoing cardiac surgery with cardiopulmonary bypass.,"['cardiac surgery with cardiopulmonary bypass', 'adult patient cardiac surgery', 'adult patients undergoing coronary revascularization, valve replacement, or combined procedures', 'patients undergoing these procedures', 'Puerta de Hierro Majadahonda University Hospital in Spain', 'adult patients', 'Adult Cardiac Surgery', 'elderly patients or those with ventricular dysfunction who are more prone to ischemia-reperfusion injury', '474 participants over the age of 18 years undergoing elective cardiac surgery with cardiopulmonary bypass', 'pediatric patients undergoing cardiac surgery with cardiopulmonary bypass']","['DNS', 'cardioplegia solutions', 'DNS or Cardi-Braun blood cardioplegia solution', 'Del Nido Cardioplegia Versus Cold Blood Cardioplegia', 'Cardi-Braun blood cardioplegia solution']","['myocardial protection in biochemical terms (ie, perioperative troponin levels) and clinical terms (ie, presence of the composite variable acute cardiovascular event']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0302583', 'cui_str': 'Iron'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0242973', 'cui_str': 'Ventricular dysfunction'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-reperfusion injury'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}, {'cui': 'C0007200', 'cui_str': 'cardioplegia solutions'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0018791', 'cui_str': 'Induced cardioplegia'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",474.0,0.161391,The del Nido cardioplegia solution (DNS) has been widely used as a myocardial preservation technique for pediatric patients undergoing cardiac surgery with cardiopulmonary bypass.,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Garcia-Suarez', 'Affiliation': 'Department of Anesthesiology and Critical Care, Puerta de Hierro Majadahonda University Hospital, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Garcia Fernandez', 'Affiliation': 'Department of Anesthesiology and Critical Care, Puerta de Hierro Majadahonda University Hospital, Madrid, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Sanz', 'Affiliation': 'Department of Anesthesiology and Critical Care, Puerta de Hierro Majadahonda University Hospital, Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Martinez Lopez', 'Affiliation': 'Department of Cardiovascular Surgery, Puerta de Hierro Majadahonda University Hospital, Majadahonda, Madrid, Spain.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Reques', 'Affiliation': 'Department of Cardiovascular Surgery, Puerta de Hierro Majadahonda University Hospital, Majadahonda, Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Forteza Gil', 'Affiliation': 'Department of Cardiovascular Surgery, Puerta de Hierro Majadahonda University Hospital, Majadahonda, Madrid, Spain.'}]",JMIR research protocols,['10.2196/17826']
1500,32679209,Intralymphatic immunotherapy improves grass pollen allergic rhinoconjunctivitis: A 3-year randomized placebo-controlled trial.,"BACKGROUND


Allergic rhinoconjunctivitis is a global health problem. Different allergen immunotherapy regimes are marketed but have low adherence because they are expensive, complex, and time-consuming. New allergen immunotherapy forms are needed.
OBJECTIVE


In a 3-year follow-up double-blind randomized placebo-controlled trial, we aimed to investigate the effect of intralymphatic allergen immunotherapy (ILIT).
METHODS


Patients with grass pollen rhinoconjunctivitis were treated with 3 ILIT injections and an ILIT booster 1 year later, 3 ILIT injections and a placebo booster, or 3 placebo injections and a placebo booster. Primary outcome was improvement in a combined symptom and medication score (cSMS). A novel evaluation tool with a linear regression model of cSMS and grass pollen counts was developed. Secondary outcomes were changes in grass specific immunoglobulins and skin and nasal provocation tests to grass pollen.
RESULTS


A total of 36 patients were included. Log 10 -transformed cSMS was reduced by 0.30 (95% CI, 0.11-0.49; P = .002), equaling 48.5% (95% CI, 24.5%-62%), in the entire 3-year follow-up period, significant only in the first follow-up season but not in the second and third seasons. The regression model showed a 37% (P < .001) reduction in cSMS. The booster injection 1 year later had no additional effect. Secondary, repeated measures of IgE and IgG 4  to grass showed significant between-group difference and within-group change in the ILIT groups. No change in provocation test results was found.
CONCLUSIONS


ILIT gives a substantial reduction in grass pollen allergy symptoms and use of rescue medication, significant in the first season after treatment. A booster injection had no additional effect.",2020,"Secondary, repeated measures of IgE and IgG 4  to grass, showed significant between-group difference and within-group change in the ILIT groups.","['36 patients were included', 'Patients with grass pollen rhinoconjunctivitis']","['ILIT injections and an ILIT booster one year later, three ILIT injection and a placebo booster or three placebo injections and a placebo booster', 'intralymphatic AIT (ILIT', 'Intralymphatic Immunotherapy', 'placebo']","['grass pollen allergic rhinoconjunctivitis', 'provocation test', 'cSMS', 'combined symptom and medication score, cSMS', 'repeated measures of IgE and IgG 4  to grass', 'changes in grass specific immunoglobulins and skin and nasal provocation tests to grass pollen']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0440307', 'cui_str': 'grass pollen'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}]","[{'cui': 'C1512956', 'cui_str': 'Intralymphatic route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0162352', 'cui_str': 'Hyposensitization to allergens'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0440307', 'cui_str': 'grass pollen'}, {'cui': 'C0861154', 'cui_str': 'Allergic rhinoconjunctivitis'}, {'cui': 'C0449428', 'cui_str': 'Provocation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4521841', 'cui_str': 'US Military enlisted E9'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0018210', 'cui_str': 'Poaceae'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0358334', 'cui_str': 'Specific immunoglobulins'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0027431', 'cui_str': 'Nasal provocation test'}]",36.0,0.678572,"Secondary, repeated measures of IgE and IgG 4  to grass, showed significant between-group difference and within-group change in the ILIT groups.","[{'ForeName': 'Søren Helbo', 'Initials': 'SH', 'LastName': 'Skaarup', 'Affiliation': 'Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Johannes Martin', 'Initials': 'JM', 'LastName': 'Schmid', 'Affiliation': 'Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Skjold', 'Affiliation': 'Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Graumann', 'Affiliation': 'Department of Radiology, Odense University Hospital, Odense, Denmark; Research and Innovation Unit of Radiology, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Hans Jürgen', 'Initials': 'HJ', 'LastName': 'Hoffmann', 'Affiliation': 'Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark. Electronic address: hjh@clin.au.dk.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.07.002']
1501,32679537,Blood pressure postpartum (BP 2 ) RCT protocol: Follow-up and lifestyle behaviour change strategies in the first 12 months after hypertensive pregnancy.,"OBJECTIVES


Women who had hypertensive disorders of pregnancy (HDP) are twice as likely to experience maternal cardiovascular disease later in life. The primary aim of this study (BP 2 ) is to compare outcomes of 3 different management strategies, including lifestyle behaviour change (LBC), in the first 12 months postpartum in women who had HDP in their preceding pregnancy. Secondary aims include assessing the effects on other cardiometabolic parameters.
STUDY DESIGN


Three-arm multicentre randomised trial in metropolitan Australian hospitals, (registration: ACTRN12618002004246) target sample size 480. Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2) Brief intervention: information package as per group 1, plus assessment and brief LBC counselling at a specialised clinic with an obstetric physician and dietitian 6 months postpartum 3) Extended intervention: as per group 2 plus enrolment into a 6 month telephone-based LBC program from 6 to 12 months postpartum. All women have an outcome assessment at 12 months.
MAIN OUTCOME MEASURES


Primary outcomes: (a) BP change or (b) weight change and/or waist circumference change.
SECONDARY OUTCOMES


maternal health-related quality of life, engagement and retention in LBC program, biochemical markers, vascular function testing, infant weight trajectory, incremental cost-effectiveness ratios. The study is powered to detect a 4 mmHg difference in systolic BP between groups, or a 4 kg weight loss difference/2cm waist circumference change.
CONCLUSIONS


BP 2  will provide evidence regarding the feasibility and effectiveness of postpartum LBC interventions and structured clinical follow-up in improving cardiovascular health markers after HDP.",2020,Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2),"['women who had HDP in their preceding pregnancy', 'Three-arm multicentre randomised trial in metropolitan Australian hospitals, (registration: ACTRN12618002004246) target sample size 480', 'Women who had hypertensive disorders of pregnancy (HDP']","['LBC counselling at a specialised clinic with an obstetric physician and dietitian 6\xa0months postpartum 3) Extended intervention: as per group 2 plus enrolment into a 6\xa0month telephone-based LBC program', 'Optimised usual care: information package and family doctor follow-up 6\xa0months postpartum 2']","['Blood pressure postpartum (BP 2 ', 'BP change or (b) weight change and/or waist circumference change', 'maternal health-related quality of life, engagement and retention in LBC program, biochemical markers, vascular function testing, infant weight trajectory, incremental cost-effectiveness ratios', 'systolic BP', 'lifestyle behaviour change (LBC']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C4319609', 'cui_str': '480'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0589124', 'cui_str': 'Follow-up 6 months'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4704805', 'cui_str': 'Weight Trajectory'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",480.0,0.118249,Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2),"[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Henry', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia; The George Institute for Global Health, Sydney, Australia. Electronic address: Amanda.Henry@unsw.edu.au.""}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Arnott', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia; Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; Faculty of Medicine, University of New South Wales, Sydney, Australia; Sydney Medical School, University of Sydney, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Makris', 'Affiliation': 'Faculty of Medicine, University of New South Wales, Sydney, Australia; School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Hennessy', 'Affiliation': 'School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Beech', 'Affiliation': 'Royal Hospital for Women, Randwick, New South Wales, Australia.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Pettit', 'Affiliation': 'Department of Renal Medicine, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Se Homer', 'Affiliation': 'Burnet Institute, Melbourne, Victoria, Australia; Faculty of Health, University of Technology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Craig', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Roberts', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.""}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Hyett', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; Sydney Medical School, University of Sydney, Australia.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Chambers', 'Affiliation': ""National Perinatal Epidemiology and Statistics Unit, School of Women's and Children's Health and Centre for Big Data Research in Health, University of New South Wales, Sydney, NSW, Australia.""}, {'ForeName': 'Oisin', 'Initials': 'O', 'LastName': 'Fitzgerald', 'Affiliation': ""National Perinatal Epidemiology and Statistics Unit, School of Women's and Children's Health and Centre for Big Data Research in Health, University of New South Wales, Sydney, NSW, Australia.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Gow', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mann', 'Affiliation': 'General Practitioner, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Challis', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Royal Hospital for Women, Randwick, New South Wales, Australia.""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Gale', 'Affiliation': 'New South Wales Ministry of Health, North Sydney, New South Wales, Australia.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Ruhotas', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Emilee', 'Initials': 'E', 'LastName': 'Kirwin', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Denney-Wilson', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Department of Renal Medicine, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.07.001']
1502,32687974,Design and rationale for a randomized trial of a theory- and technology- enhanced physical activity intervention for Latinas: The Seamos Activas II study.,"INTRODUCTION


Latina women report disproportionately high rates of physical inactivity and related chronic health conditions. Physical activity (PA) efforts to date have shown modest success in this at-risk population; thus, more effective interventions are necessary to help Latinas reach national PA guidelines and reduce related health disparities. This paper describes the design, rationale, and baseline findings from the Seamos Activas II intervention.
METHODS/DESIGN


The ongoing RCT will test the efficacy of the Seamos Saludables PA print intervention vs. a theory-and technology-enhanced version (Seamos Activas II). The purpose of the study is to increase the percentage of Latinas meeting the national PA guidelines compared to the prior trial, improve biomarkers related to disease, and extend generalizability to a broader and more representative population of Latinas (i.e. Mexican/Mexican-Americans). Intervention refinements included further targeting key constructs of Social Cognitive Theory, and incorporating interactive text message-based self-monitoring strategies. The primary outcome is change in minutes per week of MVPA measured by ActiGraph GT3X+ accelerometers at 6- and 12-months. Secondary PA outcomes assessed by the 7-Day PA Recall will be used to corroborate findings.
RESULTS


Participants (N = 199) are Latinas 18-65 years (mean = 43.8) of predominantly Mexican origin (89%). At baseline, objectively measured MVPA was 39.51 min/week (SD = 71.20, median = 10) and self-reported MVPA was 12.47 min/week (SD = 22.54, median = 0).Participants reported generally low self-efficacy and higher cognitive vs. behavioral processes of change.
CONCLUSION


Addressing interactivity and accountability through text messaging, and more rigorously targeting theoretical constructs may be key to helping Latinas achieve nationally recommended PA levels and thereby reducing health disparities.",2020,"Intervention refinements included further targeting key constructs of Social Cognitive Theory, and incorporating interactive text message-based self-monitoring strategies.","['representative population of Latinas (i.e. Mexican/Mexican-Americans', 'Latina women report disproportionately high rates of physical inactivity and related chronic health conditions', 'Participants (N\u202f=\u202f199) are Latinas 18-65\u202fyears (mean\u202f=\u202f43.8) of predominantly Mexican origin (89', 'Latinas']","['Social Cognitive Theory, and incorporating interactive text message-based self-monitoring strategies', 'theory- and technology- enhanced physical activity intervention']","['low self-efficacy and higher cognitive vs. behavioral processes of change', 'change in minutes per week of MVPA measured by ActiGraph GT3X+ accelerometers']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0025884', 'cui_str': 'Chicanos'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3890554', 'cui_str': 'Physical Inactivity'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2712043', 'cui_str': 'Lacking belief in own ability'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0266557,"Intervention refinements included further targeting key constructs of Social Cognitive Theory, and incorporating interactive text message-based self-monitoring strategies.","[{'ForeName': 'Tanya J', 'Initials': 'TJ', 'LastName': 'Benitez', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, United States of America.'}, {'ForeName': 'Shira I', 'Initials': 'SI', 'LastName': 'Dunsiger', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, United States of America.'}, {'ForeName': 'Dori J', 'Initials': 'DJ', 'LastName': 'Pekmezi', 'Affiliation': 'Department of Health Behavior, School of Public Health at University of Alabama at Birmingham, Birmingham, AL, United States of America.'}, {'ForeName': 'Britta A', 'Initials': 'BA', 'LastName': 'Larsen', 'Affiliation': 'Department of Family Medicine & Public Health, University of California San Diego, La Jolla, CA, United States of America.'}, {'ForeName': 'Andrea S', 'Initials': 'AS', 'LastName': 'Mendoza-Vasconez', 'Affiliation': 'School of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Linke', 'Affiliation': 'Department of Family Medicine & Public Health, University of California San Diego, La Jolla, CA, United States of America.'}, {'ForeName': 'Beth C', 'Initials': 'BC', 'LastName': 'Bock', 'Affiliation': 'Department of Psychiatry & Human Behavior, Alpert Medical School, Brown University, Providence, RI, United States of America.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Gans', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, United States of America; Department of Human Development and Family Studies, University of Connecticut, Storrs, CT, United States of America.'}, {'ForeName': 'Sheri J', 'Initials': 'SJ', 'LastName': 'Hartman', 'Affiliation': 'Department of Family Medicine & Public Health, University of California San Diego, La Jolla, CA, United States of America.'}, {'ForeName': 'Bess H', 'Initials': 'BH', 'LastName': 'Marcus', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, United States of America. Electronic address: bess_marcus@brown.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106081']
1503,32700364,Interventions commonly available during pandemics for heavy menstrual bleeding: an overview of Cochrane Reviews.,"BACKGROUND


Within the context of heavy menstrual bleeding, pandemics impact upon women's assessment and treatment by healthcare providers.
OBJECTIVES


To summarise the evidence from Cochrane Reviews evaluating interventions for heavy menstrual bleeding that are commonly available during pandemics.
METHODS


We sought published Cochrane Reviews, evaluating interventions that can continue during pandemics for women with heavy menstrual bleeding with no known underlying cause. We identified Cochrane Reviews by searching the Cochrane Database of Systematic Reviews in June 2020. The primary outcome was menstrual bleeding. Secondary outcomes included quality of life, patient satisfaction, side effects, and serious adverse events. We undertook the selection of systematic reviews, data extraction, and quality assessment in duplicate. We resolved any disagreements by discussion. We assessed review quality using the Assessing the Methodological Quality of Systematic Reviews (AMSTAR) 2 tool, and the certainty of the evidence for each outcome using GRADE methods.
MAIN RESULTS


We included four Cochrane Reviews, with 11 comparisons, data from 44 randomised controlled trials (RCTs), and 3196 women. We assessed all the reviews to be high quality. Non-steroidal anti-inflammatory drugs (NSAIDs) NSAIDs may be more effective in reducing heavy menstrual bleeding than placebo (mean difference (MD) -124 mL per cycle, 95% confidence interval (CI) -186 to -62 mL per cycle; 1 RCT, 11 women; low-certainty evidence). Mefenamic acid may be similar to naproxen (MD 21 mL per cycle, 95% CI -6 to 48 mL per cycle; 2 RCTs, 61 women; low-certainty evidence), and NSAIDs may be similar to combined hormonal contraceptives for heavy menstrual bleeding (MD 25 mL per cycle, 95% CI -22 to 73 mL per cycle; 1 RCT, 26 women; low-certainty evidence). NSAIDs may be be less effective in reducing menstrual bleeding than antifibrinolytics (relative risk (RR) 0.70, 95% CI 0.58 to 0.85; 2 RCTs, 161 women; low-certainty evidence). We are uncertain whether NSAIDs reduce menstrual blood loss more than short-cycle progestogens (RR 0.80, 95% CI 0.49 to 1.32; 1 RCT 32 women; very low-certainty evidence). Antifibrinolytics Antifibrinolytics appear to be more effective in reducing heavy menstrual bleeding than placebo (MD -53 mL per cycle, 95% CI -63 to -44 mL per cycle; 4 RCTs, 565 women; moderate-certainty evidence). Antifibrinolytics may be similar to placebo on the incidence of side effects (RR 1.05, 95% CI 0.93 to 1.18; 1 RCT, 297 women; low-certainty evidence), and they are probably similar on the incidence of serious adverse events (thrombotic events; RR 0.10, 95% CI 0.00 to 2.46; 2 RCT, 468 women; moderate-certainty evidence). Antifibrinolytics may be more effective in reducing heavy menstrual bleeding than short-cycle progestogen (MD -111 mL per cycle, 95% CI -178 mL to -44 mL per cycle; 1 RCT, 46 women; low-certainty evidence). We are uncertain whether antifibrinolytics are similar to short-cycle progestogens on quality of life (RR 1.67, 95% CI 0.76 to 3.64; 1 RCT, 44 women; very low-certainty evidence), patient satisfaction (RR 0.91, 95% CI 0.59 to 1.39; 1 RCT, 42 women; very low-certainty evidence), or side effects (RR 0.85, 95% CI 0.65 to 1.12; 3 RCTs, 211 women; very low-certainty evidence). We are uncertain whether antifibrinolytics are more effective in reducing heavy menstrual bleeding when compared with long-cycle progestogen (MD -9 points per cycle, 95% CI -30 to 12 points per cycle; 2 RCTs, 184 women; low-certainty evidence). Antifibrinolytics may increase self-reported improvement in menstrual bleeding when compared with long-cycle medroxyprogesterone acetate (RR 1.32, 95% CI 1.08 to 1.61; 1 RCT, 94 women; low-certainty evidence). Antifibrinolytics may be similar to long-cycle progestogens on quality of life (MD 5, 95% CI -2.49 to 12.49; 1 RCT, 90 women; low-certainty evidence). We are uncertain whether antifibrinolytics are similar to long-cycle progestogens on side effects (RR 0.58, 95% CI 0.33 to 1.00; 2 RCTs, 184 women; very low-certainty evidence). There were no trials comparing antifibrinolytics to combined hormonal contraceptives. Combined hormonal contraceptives Combined hormonal contraceptives appear to be more effective for heavy menstrual bleeding than placebo or no treatment (RR 13.25, 95% CI 2.94 to 59.64; 2 RCTs, 363 women; moderate-certainty evidence). Combined hormonal contraceptives are probably similar to placebo on the incidence of side effects (RR 1.53, 95% CI 0.90 to 2.60; 2 RCTs, 411 women; moderate-certainty evidence). Progestogens There were no trials comparing progestogens to placebo. Limitations in the evidence included risk of bias in the primary RCTs, inconsistency between the primary RCTs, and imprecision in effect estimates.
AUTHORS' CONCLUSIONS


There is moderate-certainty evidence that antifibrinolytics and combined hormonal contraceptives reduce heavy menstrual bleeding compared with placebo. There is low-certainty evidence that NSAIDs reduce heavy menstrual bleeding compared with placebo. There is low-certainty evidence that antifibrinolytics are more effective in reducing heavy menstrual bleeding when compared with NSAIDs and short-cycle progestogens, but we are unable to draw conclusions about the effects of antifibrinolytics compared to long-cycle progestogens, on low-certainty evidence.",2020,"Combined hormonal contraceptives are probably similar to placebo on the incidence of side effects (RR 1.53, 95% CI 0.90 to 2.60; 2 RCTs, 411 women; moderate-certainty evidence).","['heavy menstrual bleeding', 'women with heavy menstrual bleeding with no known underlying cause', '3196 women']","['Progestogens', 'Mefenamic acid', 'medroxyprogesterone acetate', 'placebo']","['quality of life', 'quality of life, patient satisfaction, side effects, and serious adverse events', 'heavy menstrual bleeding', 'menstrual blood loss', 'menstrual bleeding', 'patient satisfaction', 'side effects']","[{'cui': 'C0025323', 'cui_str': 'Menorrhagia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205309', 'cui_str': 'Known'}]","[{'cui': 'C0033306', 'cui_str': 'Progestational hormone'}, {'cui': 'C0025152', 'cui_str': 'mefenamic acid'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0025323', 'cui_str': 'Menorrhagia'}, {'cui': 'C0694689', 'cui_str': 'Menstrual blood'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}]",4.0,0.562988,"Combined hormonal contraceptives are probably similar to placebo on the incidence of side effects (RR 1.53, 95% CI 0.90 to 2.60; 2 RCTs, 411 women; moderate-certainty evidence).","[{'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Bofill Rodriguez', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Lethaby', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Farquhar', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'James Mn', 'Initials': 'JM', 'LastName': 'Duffy', 'Affiliation': ""King's Fertility, Fetal Medicine Research Institute, London, UK.""}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD013651.pub2']
1504,32703038,Multiple functions of policosanol in elderly patients with dyslipidemia.,"OBJECTIVE


To determine the multiple functions of policosanol in elderly dyslipidemia patients. Methodology:  There were 294 elderly dyslipidemia patients enrolled into this clinical study. They were randomly divided into four groups, as follows: 20 mg policosanol (group A, n = 64); 10 mg policosanol (group B, n = 72); 20 mg atorvastatin (group C, n = 91); and 10 mg policosanol + 20 mg atorvastatin (group D, n = 62). Plasma platelet count, platelet aggregation rate, circulating endothelial cell (CEC) count, high sensitivity C-reactive protein (hs-CRP), and carotid intima-media thickness (IMT) were measured before the study (week 0) and at weeks 12, 24, and 52.
RESULTS


In group A, the platelet aggregation rate caused by adenosine diphosphate (ADP) after treatment was significantly decreased compared with before treatment (48.79% ± 20.29% vs. 40.37% ± 23.56%), but the arachidonic acid (AA)-induced platelet aggregation rates were similar. The platelet aggregation rates induced by AA and ADP in groups B, C, and D did not change significantly. CEC counts and hs-CRP and homocysteine levels in all groups after treatment were significantly lower compared with before treatment, but carotid IMTs were similar.
CONCLUSION


Policosanol regulates blood lipid levels and improves endothelial cell function, and it could delay the progress of atherosclerosis. Trial registration number:  ChiCTR-RRC-17013396 (retrospectively registered).",2020,"In group A, the platelet aggregation rate caused by adenosine diphosphate (ADP) after treatment was significantly decreased compared with before treatment (48.79% ± 20.29% vs. 40.37% ± 23.56%), but the arachidonic acid (AA)-induced platelet aggregation rates were similar.","['elderly patients with dyslipidemia', '294 elderly dyslipidemia patients enrolled into this clinical study', 'elderly dyslipidemia patients']","['atorvastatin', 'policosanol', 'Policosanol', 'policosanol\u2009+\u200920\u2009mg atorvastatin']","['arachidonic acid (AA)-induced platelet aggregation rates', 'Plasma platelet count, platelet aggregation rate, circulating endothelial cell (CEC) count, high sensitivity C-reactive protein (hs-CRP), and carotid intima-media thickness (IMT', 'platelet aggregation rates', 'endothelial cell function', 'CEC counts and hs-CRP and homocysteine levels', 'carotid IMTs', 'platelet aggregation rate caused by adenosine diphosphate (ADP']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0215278', 'cui_str': 'policosanol'}]","[{'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C1268819', 'cui_str': 'Induced platelet aggregation'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0334121', 'cui_str': 'Inflammatory myofibroblastic tumor'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0318601', 'cui_str': 'Canine enteric calicivirus'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C2242817', 'cui_str': 'Homocysteine measurement'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0001459', 'cui_str': 'Adenosine diphosphate'}]",294.0,0.0213996,"In group A, the platelet aggregation rate caused by adenosine diphosphate (ADP) after treatment was significantly decreased compared with before treatment (48.79% ± 20.29% vs. 40.37% ± 23.56%), but the arachidonic acid (AA)-induced platelet aggregation rates were similar.","[{'ForeName': 'Chunlin', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Second Department of Internal Medicine, 316 Hospital of PLA, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'First Department of Cardiovascular Diseases, South Building, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Quanjin', 'Initials': 'Q', 'LastName': 'Si', 'Affiliation': 'First Department of Cardiovascular Diseases, South Building, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Kailiang', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'First Department of Cardiovascular Diseases, South Building, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'First Department of Cardiovascular Diseases, South Building, Chinese PLA General Hospital, Beijing, China.'}]",The Journal of international medical research,['10.1177/0300060520936082']
1505,32680742,Preoperative physiotherapy is cost-effective for preventing pulmonary complications after major abdominal surgery: a health economic analysis of a multicentre randomised trial.,"QUESTION


Is preoperative physiotherapy cost-effective in reducing postoperative pulmonary complications (PPC) and improving quality-adjusted life years (QALYs) after major abdominal surgery?
DESIGN


Cost-effectiveness analysis from the hospitals' perspective within a multicentre randomised controlled trial with concealed allocation, blinded assessors and intention-to-treat analysis.
PARTICIPANTS


Four hundred and forty-one adults awaiting elective upper abdominal surgery attending pre-anaesthetic clinics at three public hospitals in Australia and New Zealand.
INTERVENTIONS


The experimental group received an information booklet and a 30-minute face-to-face session, involving respiratory education and breathing exercise training, with a physiotherapist. The control group received the information booklet only.
OUTCOME MEASURES


The probability of cost-effectiveness and incremental net benefits was estimated using bootstrapped incremental PPC and QALY cost-effectiveness ratios plotted on cost-effectiveness planes and associated probability curves through a range of willingness-to-pay amounts. Cost-effectiveness modelling utilised 21-day postoperative hospital cost audit data and QALYs estimated from Short Form-Six Domain health utilities and mortality to 12 months.
RESULTS


Preoperative physiotherapy had 95% probability of being cost-effective with an incremental net benefit to participating hospitals of A$4,958 (95% CI 10 to 9,197) for each PPC prevented, given that the hospitals were willing to pay $45,000 to provide the service. Cost-utility for QALY gains was less certain. Sensitivity analyses strengthened cost-effectiveness findings. Improved cost-effectiveness and QALY gains were detected when experienced physiotherapists delivered the intervention.
CONCLUSIONS


Preoperative physiotherapy aimed at preventing PPCs was highly likely to be cost-effective from the hospitals' perspective. For each PPC prevented, preoperative physiotherapy is likely to cost the hospitals less than the costs estimated to treat a PPC after surgery. Potential QALY gains require confirmation.
TRIAL REGISTRATION


ACTRN12613000664741.",2020,"QUESTION


Is preoperative physiotherapy cost-effective in reducing postoperative pulmonary complications (PPC) and improving quality-adjusted life years (QALYs) after major abdominal surgery?
","['Four hundred and forty-one adults awaiting elective upper abdominal surgery attending pre-anaesthetic clinics at three public hospitals in Australia and New Zealand', 'pulmonary complications after major abdominal surgery']","['Preoperative physiotherapy', 'information booklet and a 30-minute face-to-face session, involving respiratory education and breathing exercise training, with a physiotherapist', 'information booklet only']","['cost-effectiveness and QALY gains', 'Cost-utility for QALY gains', 'probability of cost-effectiveness and incremental net benefits']","[{'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1998150', 'cui_str': 'Respiratory education'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}]",441.0,0.169058,"QUESTION


Is preoperative physiotherapy cost-effective in reducing postoperative pulmonary complications (PPC) and improving quality-adjusted life years (QALYs) after major abdominal surgery?
","[{'ForeName': 'Ianthe', 'Initials': 'I', 'LastName': 'Boden', 'Affiliation': 'Department of Physiotherapy, Launceston General Hospital, Launceston, Australia; Melbourne School of Health Sciences, The University of Melbourne, Melbourne, Australia. Electronic address: ianthe.boden@ths.tas.gov.au.'}, {'ForeName': 'Iain K', 'Initials': 'IK', 'LastName': 'Robertson', 'Affiliation': 'School of Health Sciences, University of Tasmania, Launceston, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Neil', 'Affiliation': 'Health Economics Research Group, Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Reeve', 'Affiliation': 'School of Clinical Sciences, Faculty of Health and Environmental Sciences, Auckland University of Technology, Auckland, New Zealand; Physiotherapy Department, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Palmer', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia; Centre for Health Policy, School of Population and Global Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Skinner', 'Affiliation': 'Department of Physiotherapy, The University of Melbourne, Melbourne, Australia; Allied Health Research Unit, Faculty of Medicine Nursing and Health Science, Monash University, Melbourne, Australia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Browning', 'Affiliation': 'Department of Physiotherapy, The University of Melbourne, Melbourne, Australia; Directorate of Community Integration, Allied Health and Service Planning, Western Health, Melbourne, Australia.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Anderson', 'Affiliation': 'Physiotherapy Department, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Cat', 'Initials': 'C', 'LastName': 'Hill', 'Affiliation': 'Physiotherapy Department, North West Regional Hospital, Burnie, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Story', 'Affiliation': 'Centre for Integrated Critical Care, Melbourne Medical School, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Denehy', 'Affiliation': 'Head Melbourne School of Health Sciences, The University of Melbourne, Melbourne, Australia; Allied Health Research lead, Peter McCallum Cancer Centre, Melbourne, Australia.'}]",Journal of physiotherapy,['10.1016/j.jphys.2020.06.005']
1506,32682049,"Employee perseverance in a ""no phone use while driving"" organizational road-safety intervention.","INTRODUCTION


This interdisciplinary study explores factors that contribute to the perseverance of participants in an organizational ""no phone use while driving"" road-safety intervention.
METHOD


The study sample comprised 200 employees (mean age 43 years; 104 females [52 %], 96 males [48 %]) from 8 organizations in Israel. Subjects completed a 4-month organizational intervention using a smartphone application that monitored smartphone use, operationalized as taps per minute, where each tap represents a single instance of contact with the screen (e.g., touching, tapping or swiping). The app also silenced notifications during the intervention stage. Changes over time in tapping-while-driving behavior were examined through self-report questionnaires and objectively through the application's monitoring function. Validated measures were used to examine factors associated with perseverance in the program.
RESULTS


Organizational safety climate and gender (male) were positively related to perseverance in the intervention. Contrary to our hypothesis, safety motivation was not found to influence perseverance.
CONCLUSIONS


The present intervention is most effective for employees with high safety climate perceptions and for male employees.
PRACTICAL APPLICATIONS


The organizational intervention presented in the current study was shown to be effective in reducing smartphone use (touching, tapping or swiping) while driving. Our findings show that people will download and use an app that actively reduces their incentive to use their phones at the wheel by silencing incoming notifications. The findings support calls to harness the positive potential of information and communications technologies for organizational interventions.",2020,"The organizational intervention presented in the current study was shown to be effective in reducing smartphone use (touching, tapping or swiping) while driving.","['employees with high safety climate perceptions and for male employees', '200 employees (mean age 43 years; 104 females [52 %], 96 males [48 %]) from 8 organizations in Israel']",[],['safety motivation'],"[{'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0022271', 'cui_str': 'Israel'}]",[],"[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",200.0,0.0146053,"The organizational intervention presented in the current study was shown to be effective in reducing smartphone use (touching, tapping or swiping) while driving.","[{'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Rispler', 'Affiliation': 'Faculty of Welfare and Health Sciences, Department of Human Services, University of Haifa, Mount Carmel, Haifa, 31905, Israel. Electronic address: clararispler5510@gmail.com.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Luria', 'Affiliation': 'Faculty of Welfare and Health Sciences, Department of Human Services, University of Haifa, Mount Carmel, Haifa, 31905, Israel. Electronic address: gluria@univ.haifa.ac.il.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105689']
1507,32688208,PROFAST: A randomised trial implementing enhanced recovery after surgery for highcomplexity advanced ovarian cancer surgery.,"BACKGROUND


Enhanced recovery after surgery (ERAS) programs include multiple perioperative elements designed to achieve early recovery after surgery and a shorter length of stay (LOS) in hospital. The PROFAST trial aimed to expand the evidence base for implementing ERAS in advanced gynaecologic oncology surgery.
METHODS


This prospective, interventional randomised clinical trial enrolled women undergoing surgery for either suspected or diagnosed advanced ovarian cancer, at a reference hospital in gynaecologic oncology in Barcelona (Spain) and who were treated after either an ERAS protocol or conventional management (CM) protocol. All enrolled women who underwent cytoreductive surgery were included in the primary analysis. The primary outcome was reduction in LOS, and secondary outcomes were incidence and type of intraoperative and postoperative complications, rate of readmission and mortality within a 30-d follow-up period. This trial is registered at ClinicalTrials.gov, number NCT02172638.
FINDINGS


From June 2014 to March 2018, 110 women were recruited, of which eleven were excluded. The ERAS group comprised 50 patients, and the CM group, 49 patients. Both groups were comparable with respect to baseline characteristics and complexity of the cytoreductive surgery, with an overall medium/high Aletti surgical complexity score of 7.4. Overall compliance to the ERAS protocol was 92%. As compared with the patients in the CM group, patients in the ERAS group had a decreased median of LOS of two days (7 versus 9 days; p = 0.0099) and a decreased rate of readmission (6% versus 20%, p = 0.0334). No further significant differences were detected with respect to incidence of intraoperative or postoperative complications, severe (Clavien-Dindo grade IIIB-IV) complications, Comprehensive Complication Index, reoperation during primary stay, or mortality.
INTERPRETATION


Patients with advanced ovarian cancer in the ERAS program had a decreased LOS and decreased rate of readmission as compared with those in CM, with no increased morbidity or mortality. This study provides important evidence for the benefits of ERAS management even for gynaecologic surgeries of medium/high complexity and suggests that ERAS should be a standard practice for cytoreductive surgeries for peritoneal carcinomatosis.",2020,"No further significant differences were detected with respect to incidence of intraoperative or postoperative complications, severe (Clavien-Dindo grade IIIB-IV) complications, Comprehensive Complication Index, reoperation during primary stay, or mortality.
","['Patients with advanced ovarian cancer', 'enrolled women undergoing surgery for either suspected or diagnosed advanced ovarian cancer, at a reference hospital in gynaecologic oncology in Barcelona (Spain) and who were treated after either an', 'All enrolled women who underwent cytoreductive surgery were included in the primary analysis', 'From June 2014 to March 2018, 110 women were recruited, of which eleven were excluded', 'advanced gynaecologic oncology surgery', 'highcomplexity advanced ovarian cancer surgery']","['PROFAST', 'ERAS', 'ERAS protocol or conventional management (CM) protocol']","['incidence of intraoperative or postoperative complications, severe (Clavien-Dindo grade IIIB-IV) complications, Comprehensive Complication Index, reoperation during primary stay, or mortality', 'incidence and type of intraoperative and postoperative complications, rate of readmission\xa0and mortality within a 30-d\xa0follow-up period', 'rate of readmission', 'morbidity or mortality', 'median of LOS', 'reduction in LOS', 'Overall compliance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0381011', 'cui_str': 'ProFast'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",110.0,0.308005,"No further significant differences were detected with respect to incidence of intraoperative or postoperative complications, severe (Clavien-Dindo grade IIIB-IV) complications, Comprehensive Complication Index, reoperation during primary stay, or mortality.
","[{'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Sánchez-Iglesias', 'Affiliation': ""Gynecological Oncology Department, Vall d'Hebron University Hospital, Barcelona, Spain. Electronic address: jlsanig@yahoo.es.""}, {'ForeName': 'Melchor', 'Initials': 'M', 'LastName': 'Carbonell-Socias', 'Affiliation': ""Gynecological Oncology Department, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Ma Assumpció', 'Initials': 'MA', 'LastName': 'Pérez-Benavente', 'Affiliation': ""Gynecological Oncology Department, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Monreal Clua', 'Affiliation': ""Gynecological Oncology Department, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Manrique-Muñoz', 'Affiliation': ""Unit of Anesthesiology and Resuscitation, Vall d'Hebron Hospital, Barcelona, Spain.""}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'García Gorriz', 'Affiliation': ""Unit of Anesthesiology and Resuscitation, Vall d'Hebron Hospital, Barcelona, Spain.""}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Burgos-Peláez', 'Affiliation': ""Nutritional Support Unit, Endocrinology and Nutrition Service, Vall d'Hebron Hospital, Barcelona, Spain.""}, {'ForeName': 'Hegoi', 'Initials': 'H', 'LastName': 'Segurola Gurrutxaga', 'Affiliation': ""Nutritional Support Unit, Endocrinology and Nutrition Service, Vall d'Hebron Hospital, Barcelona, Spain.""}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Pamies Serrano', 'Affiliation': ""Nutritional Support Unit, Endocrinology and Nutrition Service, Vall d'Hebron Hospital, Barcelona, Spain.""}, {'ForeName': 'Ma Del', 'Initials': 'MD', 'LastName': 'Pilar Gutiérrez-Barceló', 'Affiliation': ""Nutritional Support Unit, Endocrinology and Nutrition Service, Vall d'Hebron Hospital, Barcelona, Spain.""}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Serrano-Castro', 'Affiliation': ""Nursing Unit for Gynecologic Oncology and Breast Diseases, Vall d'Hebron Hospital, Barcelona, Spain.""}, {'ForeName': 'Ma Teresa', 'Initials': 'MT', 'LastName': 'Balcells-Farré', 'Affiliation': ""Data and Innovation Department, Vall d'Hebron Hospital, Barcelona, Spain; Research Group of Healthcare System Management, Vall d'Hebron Institut de Recerca (VHIR), Barcelona, Spain.""}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Pérez-Barragán', 'Affiliation': ""Data and Innovation Department, Vall d'Hebron Hospital, Barcelona, Spain; Research Group of Healthcare System Management, Vall d'Hebron Institut de Recerca (VHIR), Barcelona, Spain.""}, {'ForeName': 'Axelle', 'Initials': 'A', 'LastName': 'Scaillet-Houberechts', 'Affiliation': ""Data and Innovation Department, Vall d'Hebron Hospital, Barcelona, Spain; Research Group of Healthcare System Management, Vall d'Hebron Institut de Recerca (VHIR), Barcelona, Spain.""}, {'ForeName': 'Yolima', 'Initials': 'Y', 'LastName': 'Cossio-Gil', 'Affiliation': ""Data and Innovation Department, Vall d'Hebron Hospital, Barcelona, Spain; Research Group of Healthcare System Management, Vall d'Hebron Institut de Recerca (VHIR), Barcelona, Spain.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gil-Moreno', 'Affiliation': ""Gynecological Oncology Department, Vall d'Hebron University Hospital, Barcelona, Spain; Biomedical Research Group in Gynecology, Vall d'Hebron Research Institute (VHIR), Universitat Autonoma de Barcelona, CIBERONC, Barcelona, Spain. Electronic address: antonioimma@yahoo.es.""}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.06.011']
1508,32687174,"Efficacy and Safety of a Naphthoquine-Azithromycin Co-Formulation for Malaria Prophylaxis in Southeast Asia: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial.","BACKGROUND


A prophylactic antimalarial drug that is both effective for protection and improves compliance is in high demand.
METHODS


We conducted a randomized, placebo-controlled, double-blinded, phase-3 trial to evaluate the 1:1 fixed-dose combination of naphthoquine-azithromycin (NQAZ) for safety and protection against Plasmodium infections in villages along the China-Myanmar border. A total of 631 residents, 5-65 years old, were randomized into the drug group (319) and the placebo group (312) to receive NZAQ and placebo, respectively, as a single-dose monthly treatment. Follow-ups were conducted weekly to monitor for adverse events and malaria infections.
RESULTS


Of the 531 subjects completing the trial, there were 46 and 3 blood smear-positive Plasmodium infections in the placebo and treatment groups, respectively. For the intent-to-treat analysis, the single-dose monthly NQAZ treatment had 93.62% protective efficacy (95% confidence interval [CI]: 91.72-95.52%). For the per-protocol analysis, NQAZ treatment provided a 93.04% protective efficacy (95% CI: 90.98-95.1%). Three smear-positive cases in the NQAZ group were all due to acute falciparum malaria. In comparison, NQAZ treatment provided 100% protection against the relapsing malaria Plasmodium vivax and Plasmodium ovale. The treatment group had 5.6% of participants experiencing transient elevation of liver transaminases as compared to 2.2% in the placebo group (P > 0.05).
CONCLUSIONS


Monthly prophylaxis with NQAZ tablets was well tolerated and highly effective for preventing Plasmodium infections. It may prove useful for eliminating P. vivax in areas with a high prevalence of glucose-6-phosphate dehydrogenase deficiency in the population.",2020,"The treatment group had 5.6% of participants experiencing transient elevation of liver transaminases as compared to 2.2% in the placebo group (P > 0.05).
","['531 subjects completing the trial', 'villages along the China-Myanmar border', 'Malaria Prophylaxis in Southeast Asia', 'A total of 631 residents, 5-65 years old']","['Placebo', 'NQAZ', 'NQAZ tablets', 'NZAQ and placebo', 'naphthoquine-azithromycin (NQAZ', 'Naphthoquine-Azithromycin Co-Formulation', 'placebo']","['Efficacy and Safety', 'relapsing malaria Plasmodium vivax and Plasmodium ovale', 'protective efficacy', 'blood smear-positive Plasmodium infections', 'tolerated and highly effective for preventing Plasmodium infections', 'transient elevation of liver transaminases']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0006416', 'cui_str': 'Burma'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0199244', 'cui_str': 'Antimalarial prophylaxis'}, {'cui': 'C0003983', 'cui_str': 'South east Asian country'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4058704', 'cui_str': 'NAPHTHOQUINE'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C1245010', 'cui_str': 'Azithromycin Oral Tablet'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0024537', 'cui_str': 'Vivax malaria'}, {'cui': 'C0320744', 'cui_str': 'Plasmodium ovale'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}]",631.0,0.633984,"The treatment group had 5.6% of participants experiencing transient elevation of liver transaminases as compared to 2.2% in the placebo group (P > 0.05).
","[{'ForeName': 'Henglin', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': ""Yunnan Institute of Parasitic Diseases, Yunnan Provincial Center of Malaria Research, Pu'er, Yunnan, China.""}, {'ForeName': 'Jingyan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Institute of Microbiology and Epidemiology, Chinese Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Yunnan Institute of Parasitic Diseases, Yunnan Provincial Center of Malaria Research, Pu'er, Yunnan, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Immunology, College of Basic Medical Sciences, China Medical University, Shenyang, Liaoning, China.'}, {'ForeName': 'Seetha', 'Initials': 'S', 'LastName': 'Lakshmi', 'Affiliation': 'Department of Internal Medicine, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Xingliang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Yunnan Institute of Parasitic Diseases, Yunnan Provincial Center of Malaria Research, Pu'er, Yunnan, China.""}, {'ForeName': 'Renhua', 'Initials': 'R', 'LastName': 'Nie', 'Affiliation': ""Yunnan Institute of Parasitic Diseases, Yunnan Provincial Center of Malaria Research, Pu'er, Yunnan, China.""}, {'ForeName': 'Chunfu', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Yunnan Institute of Parasitic Diseases, Yunnan Provincial Center of Malaria Research, Pu'er, Yunnan, China.""}, {'ForeName': 'Hengye', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Yunnan Institute of Parasitic Diseases, Yunnan Provincial Center of Malaria Research, Pu'er, Yunnan, China.""}, {'ForeName': 'Yaming', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Department of Immunology, College of Basic Medical Sciences, China Medical University, Shenyang, Liaoning, China.'}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Menezes', 'Affiliation': 'Department of Internal Medicine, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Liwang', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': 'Department of Internal Medicine, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1018']
1509,32682815,Acceptance and Commitment Therapy for Primary Headache Sufferers: A Randomized Controlled Trial of Efficacy.,"Prevention of headaches via avoidance of triggers remains the main behavioral treatment suggestion for headache management despite trigger avoidance resulting in increases in potency, lifestyle restrictions, internal locus of control decreases, pain exacerbation and maintenance. New approaches, such as Acceptance and Commitment Therapy (ACT), instead emphasize acceptance and valued living as alternatives to avoidance. Though ACT is an empirically supported treatment for chronic pain, there is limited evidence for headache management while preliminary outcome studies are afflicted with methodological limitations. This study compared an ACT-based group headache-specific intervention to wait-list control, in a randomized clinical trial, on disability, distress, medical utilization, functioning, and quality of life. Ninety-four individuals with primary headache (84% women; Mage = 43 years; 87.35% migraine diagnosis) were randomized into 2 groups (47 in each). Assessments occurred: before, immediately after, and at 3 months following treatment end. Only the ACT group was additionally assessed at 6- and 12-month follow-up. Results (intent to treat analyses corroborated by linear mixed model analyses) showed substantial improvements in favor of ACT compared to control, on disability, quality of life, functional status, and depression at 3-, 6-, and 12-month follow-up. Improvements were maintained in the ACT group at 6- and 12-month follow-up. At 3-month follow-up, clinical improvement occurred in headache-related disability (63%) and 65% in quality of life in ACT versus 37% and 35% in control. These findings offer new evidence for the utility and efficacy of ACT in localized pain conditions and yields evidence for both statistical and clinical improvements over a years' period. PERSPECTIVE: An Acceptance and Commitment Therapy approach focusing on acceptance and values-based activities was found to improve disability, functioning, and quality of life among patients with primary headaches.",2020,"At 3-month follow-up, clinical improvement occurred in headache-related disability (63%) and 65% in quality of life in ACT vs. 37% & 35% in control.","['94 individuals with primary headache (84% women; Mage=43 years; 87.35% migraine diagnosis', 'Primary Headache Sufferers', 'patients with primary headaches']","['ACT-based group headache-specific intervention to wait-list control', 'ACT']","['quality of life', 'headache-related disability', 'disability, quality of life, functional status, and depression', 'disability, distress, medical utilization, functioning and quality of life', 'disability, functioning and quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",94.0,0.0922623,"At 3-month follow-up, clinical improvement occurred in headache-related disability (63%) and 65% in quality of life in ACT vs. 37% & 35% in control.","[{'ForeName': 'Vasilis S', 'Initials': 'VS', 'LastName': 'Vasiliou', 'Affiliation': 'Department of Applied Psychology, University College Cork, Cork, Ireland.'}, {'ForeName': 'Evangelos C', 'Initials': 'EC', 'LastName': 'Karademas', 'Affiliation': 'Department of Psychology, University of Crete, Rethymnon, Greece.'}, {'ForeName': 'Yiolanda', 'Initials': 'Y', 'LastName': 'Christou', 'Affiliation': ""Neurology Clinic B', The Cyprus Institute of Neurology and Genetics, Nicosia, Cyprus.""}, {'ForeName': 'Savvas', 'Initials': 'S', 'LastName': 'Papacostas', 'Affiliation': ""Neurology Clinic B', The Cyprus Institute of Neurology and Genetics, Nicosia, Cyprus.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Karekla', 'Affiliation': 'Department of Psychology, ACThealthy Laboratory, University of Cyprus, Nicosia, Cyprus. Electronic address: mkarekla@ucy.ac.cy.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2020.06.006']
1510,32692247,Clinical study on different doses and fractionated radiotherapies for multiple brain metastases of non-EGFR mutant lung adenocarcinoma.,"BACKGROUND


To study the effects and adverse reactions of different doses and fractionated radiotherapies on non-epidermal growth factor receptor (EGFR) mutant lung adenocarcinoma patients with multiple brain metastases.
METHODS


In total, 80 patients eligible for inclusion were randomly divided into 4 groups. Group A included whole brain radiotherapy (WBRT) alone 300 cGy/fraction ×10 fractions, at a total dose of 3,000 cGy. Group B included WBRT alone 180 cGy/fraction ×22 fractions, at a total dose of 3,960 cGy. Group C included intracranial metastases radiotherapy alone 250 cGy/fraction ×22 fractions at a total dose of 5,500 cGy. Group D included the whole brain + intracranial metastases group (SIB group) whole brain 180 cGy/fraction ×22 fractions intracranial metastases 250 cGy/fraction ×22 fractions, at a total dose 3,960 cGy, 5,500 cGy, respectively.
RESULTS


The median survival time of intracranial disease-free survival (IPFS) in group A, group B, group C, and group D was 6, 9, 8, and 13 months, respectively (P=0.000). The median overall survival (OS) time was 16, 24.5, 24, and 30 months, respectively (P=0.150). There was a significant difference in IPFS between different doses and fractionated radiotherapies, but there was no difference in OS. Multivariate analysis showed that the radiotherapy dose of intracranial metastases was positively correlated with IPFS and OS. The incidence rate of adverse reaction of memory decline in 0.5, 1, and 2 years in group A, group B, group C, and group D was respectively 10.0%, 15.0%, 5.0%, and 15.0% (P=0.006); 20.0%, 45.0%, 30.0%, and 60.0% (P=0.000); 10.0%, 20.0%, 35.0%, and 65.0% (P=0.000). The incidence rates of memory decline in the groups of WBRT were significantly more increased than in the non-WBRT group.
CONCLUSIONS


Radiotherapy is effective for multiple brain metastases of lung adenocarcinoma, the increase of radiotherapy dose can improve IPFS and OS, and the adverse reaction of memory decline after WBRT is increased but tolerable. Therefore, WBRT and simultaneous integrated boost (SIB) radiotherapy of intracranial metastases is recommended for multiple brain metastases of non-EGFR-mutant lung adenocarcinoma.",2020,"The incidence rates of memory decline in the groups of WBRT were significantly more increased than in the non-WBRT group.
","['multiple brain metastases of non-EGFR mutant lung adenocarcinoma', '80 patients eligible for inclusion', 'lung adenocarcinoma patients with multiple brain metastases']","['whole brain radiotherapy (WBRT) alone 300 cGy/fraction ×10 fractions', 'WBRT and simultaneous integrated boost (SIB) radiotherapy', 'fractionated radiotherapies', 'whole brain + intracranial metastases group (SIB group) whole brain 180 cGy/fraction ×22 fractions intracranial metastases 250 cGy/fraction ×22 fractions', 'WBRT', 'Radiotherapy']","['median survival time of intracranial disease-free survival (IPFS', 'IPFS', 'OS', 'median overall survival (OS) time', 'incidence rate of adverse reaction of memory decline', 'incidence rates of memory decline']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0152013', 'cui_str': 'Adenocarcinoma of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C1520143', 'cui_str': 'Whole brain radiation therapy'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0556645', 'cui_str': 'cGy'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",80.0,0.0197721,"The incidence rates of memory decline in the groups of WBRT were significantly more increased than in the non-WBRT group.
","[{'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'School of Medicine and Life Science, University of Jinan-Shandong Academy of Medical Sciences, Jining Tumor Hospital, Jinan, China.'}, {'ForeName': 'Xuedong', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Radiation Oncology (Chest Section), Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.'}, {'ForeName': 'Jinzhi', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology (Chest Section), Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology (Chest Section), Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.'}, {'ForeName': 'Changsheng', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Department of Radiophysics and Technology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Sun', 'Affiliation': 'Department of Radiophysics and Technology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Shao', 'Affiliation': 'Department of Radiation Oncology (Chest Section), Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China. shaoqian2009@sina.com.'}]",Annals of palliative medicine,['10.21037/apm-20-1203']
1511,32693009,Physical exercise interventions have no effect on serum BDNF concentration in older adults living in long-term nursing homes.,"Physical exercise protects against age-related cognitive decline. Brain-derived neurotrophic factor (BDNF) may mediate some of the cognitive benefits of physical exercise, but the effect of physical exercise on serum BDNF is unclear. Indeed, differential findings have been reported depending on the characteristics of the participants and the intensity, duration, and type of exercise. The aim of this study was to determine whether three different physical exercise interventions alter serum BDNF levels in older adults living in long-term nursing homes (LTNHs) and whether changes in physical, cognitive, and dual-task performance are related to changes in serum BDNF. LTNH study participants (n = 126) were randomly assigned to multicomponent or dual-task training or a walking program and serum BDNF levels were analyzed by ELISA. We also assessed physical, cognitive, and dual-task parameters. Neither the multicomponent, dual-task, nor walking exercise programs caused changes in serum BDNF concentration in older adults living in LTNHs. Changes in BDNF during the interventions were not significantly associated with modifications in physical, cognitive or dual-task performance parameters. Our results provide new evidence clarifying the relationship between physical and cognitive exercise and BDNF.",2020,"Neither the multicomponent, dual-task, nor walking exercise programs caused changes in serum BDNF concentration in older adults living in LTNHs.","['older adults living in long-term nursing homes (LTNHs', 'older adults living in LTNHs', 'LTNH study participants (n\u202f=\u202f126', 'older adults living in long-term nursing homes']","['physical exercise interventions', 'multicomponent or dual-task training or a walking program and serum BDNF levels were analyzed by ELISA', 'Physical exercise', 'multicomponent, dual-task, nor walking exercise programs', 'Physical exercise interventions']","['physical, cognitive, and dual-task parameters', 'physical, cognitive or dual-task performance parameters', 'serum BDNF levels', 'serum BDNF concentration']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0470256', 'cui_str': '126'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",126.0,0.0209679,"Neither the multicomponent, dual-task, nor walking exercise programs caused changes in serum BDNF concentration in older adults living in LTNHs.","[{'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Rezola-Pardo', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursery, University of the Basque Country, Bo Sarriena s/n, Leioa 48940, Bizkaia, Spain. Electronic address: chloe.rezola@ehu.eus.'}, {'ForeName': 'Gotzone', 'Initials': 'G', 'LastName': 'Hervás', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursery, University of the Basque Country, Bo Sarriena s/n, Leioa 48940, Bizkaia, Spain. Electronic address: gotzone.hervas@ehu.eus.'}, {'ForeName': 'Haritz', 'Initials': 'H', 'LastName': 'Arrieta', 'Affiliation': 'Department of Nursing II, Faculty of Medicine and Nursery, University of the Basque Country (UPV/EHU), Paseo Dr. J. Beguiristain, 105, Donostia/San Sebastian 20014, Gipuzkoa, Spain; Onkologikoa Foundation, Paseo Doctor Beguiristain, 121, Donostia/San Sebastián 20014, Gipuzkoa, Spain. Electronic address: haritz.arrieta@ehu.eus.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Hernández-de Diego', 'Affiliation': 'Zorroaga Foundation, Alto Zorroaga, 1, Donostia/San Sebastian 20014, Gipuzkoa, Spain. Electronic address: s.hernandez@zorroaga.eus.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Ruiz-Litago', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursery, University of the Basque Country, Bo Sarriena s/n, Leioa 48940, Bizkaia, Spain. Electronic address: fatima.ruiz@ehu.eus.'}, {'ForeName': 'Susana Maria', 'Initials': 'SM', 'LastName': 'Gil', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursery, University of the Basque Country, Bo Sarriena s/n, Leioa 48940, Bizkaia, Spain. Electronic address: susana.gil@ehu.eus.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Rodriguez-Larrad', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursery, University of the Basque Country, Bo Sarriena s/n, Leioa 48940, Bizkaia, Spain. Electronic address: ana.rodriguez@ehu.eus.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Irazusta', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursery, University of the Basque Country, Bo Sarriena s/n, Leioa 48940, Bizkaia, Spain. Electronic address: jon.irazusta@ehu.eus.'}]",Experimental gerontology,['10.1016/j.exger.2020.111024']
1512,32694748,A tele-health intervention to increase physical fitness in people with spinal cord injury and cardiometabolic disease or risk factors: a pilot randomized controlled trial.,"STUDY DESIGN


Clinical trial.
OBJECTIVES


We used a single-blind parallel-group design to test the feasibility and preliminary efficacy of a telehealth-based physical activity counseling intervention to increase physical fitness in people with SCI.
SETTING


Seattle, Washington, United States.
METHODS


We recruited under-active, manual wheelchair-using adults at least 1-year post-SCI who had at least two cardiometabolic risk factors/diseases. Participants underwent baseline tests of peak cardiorespiratory fitness; lipids, glucose and insulin; muscle and fat mass; self-reported physical activity, depression, pain and other factors. Participants were assigned 1:1 to treatment vs. usual care (UC) control conditions via concealed computerized randomization. Treatment was delivered via telephone and adapted from the 16-session Diabetes Prevention Program. All baseline tests were repeated at 6 months. Prespecified feasibility goals were to recruit at least nine participants/quarter and retain 85% with complete fitness testing at 6 months. Prespecified efficacy goals were to demonstrate at least a medium treatment effect size (0.50) on fitness, self-reported physical activity, and other outcomes.
RESULTS


Seven participants were randomized to treatment, 8 to UC over 15 months. Maximum recruitment was only 5.4 participants/quarter. Thirteen (87%) of participants were retained. The effects of treatment on fitness and most cardiometabolic risk factors did not meet expectations, whereas the effects on self-reported physical activity, depression, and pain did meet expectations.
CONCLUSIONS


The study did not meet key efficacy and feasibility objectives, yet there were some promising effects on self-report measures and lessons to be learned for designing future trials.",2020,"The effects of treatment on fitness and most cardiometabolic risk factors did not meet expectations, whereas the effects on self-reported physical activity, depression, and pain did meet expectations.
","['We recruited under-active, manual wheelchair-using adults at least 1-year post-SCI who had at least two cardiometabolic risk factors/diseases', 'Seattle, Washington, United States', 'people with spinal cord injury and cardiometabolic disease or risk factors', 'people with SCI']","['usual care (UC) control conditions via concealed computerized randomization', 'telehealth-based physical activity counseling intervention', 'health intervention']","['physical fitness', 'fitness, self-reported physical activity, and other outcomes', 'peak cardiorespiratory fitness; lipids, glucose and insulin; muscle and fat mass; self-reported physical activity, depression, pain and other factors']","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0184423', 'cui_str': 'Manual wheelchair'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0443189', 'cui_str': 'Concealed'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",7.0,0.120234,"The effects of treatment on fitness and most cardiometabolic risk factors did not meet expectations, whereas the effects on self-reported physical activity, depression, and pain did meet expectations.
","[{'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Bombardier', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA. chb@uw.edu.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Dyer', 'Affiliation': 'Peacehealth Medical Group, Vancouver, WA, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Burns', 'Affiliation': 'The Miami Project to Cure Paralysis, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Crane', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Takahashi', 'Affiliation': 'Department of Ophthalmology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Barber', 'Affiliation': 'Department of Neurosurgery, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Nash', 'Affiliation': 'Departments of Neurological Surgery, Physical Medicine & Rehabilitation and Physical Therapy, University of Miami Miller School of Medicine, Miami, FL, USA.'}]",Spinal cord,['10.1038/s41393-020-0523-6']
1513,32697909,Improved Fast Randomized Iteration Approach to Full Configuration Interaction.,"We present three modifications to our recently introduced fast randomized iteration method for full configuration interaction (FCI-FRI) and investigate their effects on the method's performance for Ne, H 2 O, and N 2 . The initiator approximation, originally developed for full configuration interaction quantum Monte Carlo, significantly reduces statistical error in FCI-FRI when few samples are used in compression operations, enabling its application to larger chemical systems. The semistochastic extension, which involves exactly preserving a fixed subset of elements in each compression, improves statistical efficiency in some cases but reduces it in others. We also developed a new approach to sampling excitations that yields consistent improvements in statistical efficiency and reductions in computational cost. We discuss possible strategies based on our findings for improving the performance of stochastic quantum chemistry methods more generally.",2020,"The initiator approximation, originally developed for full configuration interaction quantum Monte Carlo, significantly reduces statistical error in FCI-FRI when few samples are used in compression operations, enabling its application to larger chemical systems.",[],[],[],[],[],[],,0.0381083,"The initiator approximation, originally developed for full configuration interaction quantum Monte Carlo, significantly reduces statistical error in FCI-FRI when few samples are used in compression operations, enabling its application to larger chemical systems.","[{'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Greene', 'Affiliation': 'Department of Chemistry, Columbia University, New York, New York 10027, United States.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Webber', 'Affiliation': 'Courant Institute of Mathematical Sciences, New York University, New York, New York 10012, United States.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Weare', 'Affiliation': 'Courant Institute of Mathematical Sciences, New York University, New York, New York 10012, United States.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Berkelbach', 'Affiliation': 'Department of Chemistry, Columbia University, New York, New York 10027, United States.'}]",Journal of chemical theory and computation,['10.1021/acs.jctc.0c00437']
1514,32702783,Aspirin (single dose) for perineal pain in the early postpartum period.,"BACKGROUND


Perineal trauma, due to spontaneous tears, surgical incision (episiotomy), or in association with operative vaginal birth, is common after vaginal birth, and is often associated with postpartum perineal pain. Birth over an intact perineum may also lead to perineal pain. There are adverse health consequences associated with perineal pain for the women and their babies in the short- and long-term, and the pain may interfere with newborn care and the establishment of breastfeeding. Aspirin has been used in the management of postpartum perineal pain, and its effectiveness and safety should be assessed. This is an update of the review, last published in 2017.
OBJECTIVES


To determine the effects of a single dose of aspirin (acetylsalicylic acid), including at different doses, in the relief of acute postpartum perineal pain.
SEARCH METHODS


For this update, we searched the Cochrane Pregnancy and Childbirth's Trials Register (4 October 2019), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (4 October 2019) and screened reference lists of retrieved studies.
SELECTION CRITERIA


Randomised controlled trials (RCTs), assessing single dose aspirin compared with placebo, no treatment, a different dose of aspirin, or single dose paracetamol or acetaminophen, for women with perineal pain in the early postpartum period. We planned to include cluster-RCTs, but none were identified. We excluded quasi-RCTs and cross-over studies.
DATA COLLECTION AND ANALYSIS


Two review authors independently assessed study eligibility, extracted data and assessed the risk of bias of the included RCTs. Data were checked for accuracy. The certainty of the evidence for the main comparison (aspirin versus placebo) was assessed using the GRADE approach.
MAIN RESULTS


We included 17 RCTs, 16 of which randomised 1132 women to aspirin or placebo; one RCT did not report numbers of women. Two RCTs (of 16) did not contribute data to meta-analyses. All women had perineal pain post-episiotomy, and were not breastfeeding. Studies were published between 1967 and 1997, and the risk of bias was often unclear, due to poor reporting. We included four comparisons: aspirin versus placebo (15 RCTs); 300 mg versus 600 mg aspirin (1 RCT); 600 mg versus 1200 mg aspirin (2 RCTs); and 300 mg versus 1200 mg aspirin (1 RCT). Aspirin versus placebo Aspirin may result in more women reporting adequate pain relief four to eight hours after administration compared with placebo (risk ratio (RR) 2.03, 95% confidence interval (CI) 1.69 to 2.42; 13 RCTs, 1001 women; low-certainty evidence). It is uncertain whether aspirin compared with placebo has an effect on the need for additional pain relief (RR 0.25, 95% CI 0.17 to 0.37; 10 RCTs, 744 women; very low-certainty evidence), or maternal adverse effects (RR 1.08, 95% CI 0.57 to 2.06; 14 RCTs, 1067 women; very low-certainty evidence), four to eight hours after administration. Analyses based on dose did not reveal any clear subgroup differences. 300 mg versus 600 mg aspirin It is uncertain whether over four hours after administration, 300 mg compared with 600 mg aspirin has an effect on adequate pain relief (RR 0.82, 95% CI 0.36 to 1.86; 1 RCT, 81 women) or the need for additional pain relief (RR 0.68, 95% CI 0.12 to 3.88; 1 RCT, 81 women). There were no maternal adverse effects in either aspirin group. 600 mg versus 1200 mg aspirin It is uncertain whether over four to eight hours after administration, 600 mg compared with 1200 mg aspirin has an effect on adequate pain relief (RR 0.85, 95% CI 0.52 to 1.39; 2 RCTs, 121 women), the need for additional pain relief (RR 1.32, 95% CI 0.30 to 5.68; 2 RCTs, 121 women), or maternal adverse effects (RR 3.00, 95% CI 0.13 to 69.52; 2 RCTs, 121 women). 300 mg versus 1200 mg aspirin It is uncertain whether over four hours after administration, 300 mg compared with 1200 mg aspirin has an effect on adequate pain relief (RR 0.62, 95% CI 0.29 to 1.32; 1 RCT, 80 women) or need for additional pain relief (RR 2.00, 95% CI 0.19 to 21.18; 1 RCT, 80 women). There were no maternal adverse effects in either aspirin group. None of the included RCTs reported on neonatal adverse effects. No RCTs reported on secondary review outcomes of: prolonged hospitalisation due to perineal pain; re-hospitalisation due to perineal pain; fully breastfeeding at discharge; mixed feeding at discharge; fully breastfeeding at six weeks; mixed feeding at six weeks; perineal pain at six weeks; maternal views; or maternal postpartum depression.
AUTHORS' CONCLUSIONS


Single dose aspirin may increase adequate pain relief in women with perineal pain post-episiotomy compared with placebo. It is uncertain whether aspirin has an effect on the need for additional analgesia, or on maternal adverse effects, compared with placebo. We downgraded the certainty of the evidence because of study limitations (risk of bias), imprecision, and publication bias. Aspirin may be considered for use in non-breastfeeding women with post-episiotomy perineal pain. Included RCTs excluded breastfeeding women, so there was no evidence to assess the effects of aspirin on neonatal adverse effects or breastfeeding. Future RCTs should be designed to ensure low risk of bias, and address gaps in the evidence, such as the secondary outcomes established for this review. Current research has focused on women with post-episiotomy pain; future RCTs could be extended to include women with perineal pain associated with spontaneous tears or operative birth.",2020,"It is uncertain whether aspirin compared with placebo has an effect on the need for additional pain relief (RR 0.25, 95% CI 0.17 to 0.37; 10 RCTs, 744 women; very low-certainty evidence), or maternal adverse effects (RR 1.08, 95% CI 0.57 to 2.06; 14 RCTs, 1067 women; very low-certainty evidence), four to eight hours after administration.","['non-breastfeeding women with post-episiotomy perineal pain', 'women with perineal pain in the early postpartum period', '17 RCTs, 16 of which randomised 1132 women to', 'women with post-episiotomy pain', 'women with perineal pain post-episiotomy']","['aspirin or placebo', 'aspirin versus placebo', 'RCT', 'placebo Aspirin', 'aspirin, or single dose paracetamol or acetaminophen', 'Aspirin', 'aspirin', 'aspirin (acetylsalicylic acid', 'placebo']","['maternal adverse effects', 'prolonged hospitalisation due to perineal pain; re-hospitalisation due to perineal pain; fully breastfeeding at discharge; mixed feeding at discharge; fully breastfeeding at six weeks; mixed feeding at six weeks; perineal pain at six weeks; maternal views; or maternal postpartum depression', 'pain relief', 'neonatal adverse effects', 'additional pain relief', 'adequate pain relief', 'perineal pain']","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0235641', 'cui_str': 'Pain in female perineum'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0406846', 'cui_str': 'Post-episiotomy pain'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0235641', 'cui_str': 'Pain in female perineum'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0549411', 'cui_str': 'Neonatal adverse effect'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}]",,0.696765,"It is uncertain whether aspirin compared with placebo has an effect on the need for additional pain relief (RR 0.25, 95% CI 0.17 to 0.37; 10 RCTs, 744 women; very low-certainty evidence), or maternal adverse effects (RR 1.08, 95% CI 0.57 to 2.06; 14 RCTs, 1067 women; very low-certainty evidence), four to eight hours after administration.","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Shepherd', 'Affiliation': 'Robinson Research Institute, Discipline of Obstetrics and Gynaecology, Adelaide Medical School, The University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Rosalie M', 'Initials': 'RM', 'LastName': 'Grivell', 'Affiliation': 'Department of Obstetrics and Gynaecology, Flinders University and Flinders Medical Centre, Bedford Park, Australia.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012129.pub3']
1515,32708741,Locally Applied Slow-Release of Minocycline Microspheres in the Treatment of Peri-Implant Mucositis: An Experimental In Vivo Study.,"BACKGROUND


The objective of this is preclinical investigation was to evaluate the differential drug sustainability and pharmacodynamic properties of two local minocycline microsphere carriers: chitosan-coated alginate (CA) and poly(meth)acrylate-glycerin (PG).
METHODS


Four dental implants were placed unilaterally in the edentulous mandible of six beagle dogs. Each implant was randomly assigned to receive one of the following four treatments: (i) CA (CA-based minocycline), (ii) placebo (CA substrate without minocycline), (iii) PG (PG-based minocycline) and (iv) control (mechanical debridement only). After inducing peri-implant mucositis, the randomly assigned treatments were administered into the gingival sulcus twice at a 4-week interval using a plastic-tipped syringe. Drug sustainability and pharmacodynamic (clinical, radiographical and cell marker intensity) evaluations were performed after each administration.
RESULTS


The CA microspheres remained longer around the healing abutment compared to the PG microspheres at both administrations and a longer bacteriostatic effect was observed from CA (7.0 ± 5.7 days) compared to PG (1.2 ± 2.6 days). The efficacy of the applied therapies based on clinical, radiographical and histological analyses were comparable across all treatment groups.
CONCLUSIONS


CA microspheres showed longer carrier and bacteriostatic effect sustainability when compared to PG microspheres, however, longer drug sustainability did not lead to improved treatment outcomes.",2020,The CA microspheres remained longer around the healing abutment compared to the PG microspheres at both administrations and a longer bacteriostatic effect was observed from CA (7.0 ± 5.7 days) compared to PG (1.2 ± 2.6 days).,"['Peri-Implant Mucositis', 'Four dental implants were placed unilaterally in the edentulous mandible of six beagle dogs']","['Minocycline Microspheres', 'CA microspheres', 'CA (CA-based minocycline), (ii) placebo (CA substrate without minocycline), (iii) PG (PG-based minocycline) and (iv) control (mechanical debridement only', 'minocycline microsphere carriers: chitosan-coated alginate (CA) and poly(meth)acrylate-glycerin (PG']","['longer carrier and bacteriostatic effect sustainability', 'bacteriostatic effect', 'Drug sustainability and pharmacodynamic (clinical, radiographical and cell marker intensity) evaluations', 'CA microspheres']","[{'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C3853359', 'cui_str': 'Edentulous mandible'}, {'cui': 'C0324306', 'cui_str': 'Beagle'}, {'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}]","[{'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C0026032', 'cui_str': 'Microbeads'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0002040', 'cui_str': 'Alginates'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0597265', 'cui_str': 'polyacrylate'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0162969', 'cui_str': 'Chitosan'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1611701', 'cui_str': 'Cell marker'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0002040', 'cui_str': 'Alginates'}, {'cui': 'C0026032', 'cui_str': 'Microbeads'}]",,0.0567987,The CA microspheres remained longer around the healing abutment compared to the PG microspheres at both administrations and a longer bacteriostatic effect was observed from CA (7.0 ± 5.7 days) compared to PG (1.2 ± 2.6 days).,"[{'ForeName': 'Sung-Wook', 'Initials': 'SW', 'LastName': 'Yoon', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, Seoul 03772, Korea.'}, {'ForeName': 'Myong-Ji', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, Seoul 03772, Korea.'}, {'ForeName': 'Kyeong-Won', 'Initials': 'KW', 'LastName': 'Paeng', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, Seoul 03772, Korea.'}, {'ForeName': 'Kyeong Ae', 'Initials': 'KA', 'LastName': 'Yu', 'Affiliation': 'College of Pharmacy, Chungbuk National University, Cheongju 28165, Korea.'}, {'ForeName': 'Chong-Kil', 'Initials': 'CK', 'LastName': 'Lee', 'Affiliation': 'College of Pharmacy, Chungbuk National University, Cheongju 28165, Korea.'}, {'ForeName': 'Young Woo', 'Initials': 'YW', 'LastName': 'Song', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, Seoul 03772, Korea.'}, {'ForeName': 'Jae-Kook', 'Initials': 'JK', 'LastName': 'Cha', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, Seoul 03772, Korea.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Sanz', 'Affiliation': 'Section of Graduate Periodontology, Faculty of Odontology, Complutense University of Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Ui-Won', 'Initials': 'UW', 'LastName': 'Jung', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, Seoul 03772, Korea.'}]",Pharmaceutics,['10.3390/pharmaceutics12070668']
1516,32710147,A phase Ι study to evaluate the application of photocyanine using pharmacokinetic and pharmacodynamic analysis in patients with malignancy.,"PURPOSE


Photodynamic therapy (PDT) schedules are based on sensitiser dose, light dose, and drug-light interval. The aim of the phase Ι study was to choose optimal dose and drug-light interval for PDT with photocyanine using pharmacokinetics (PK) and pharmacodynamics (PD).
METHODS


Twenty-eight cancer patients were enrolled. In trial A, 12 patients received one of four ascending doses of photocyanine intravenously 24 h prior to 180-270 J/cm 2  illumination. 0.2 mg/kg dose was infused to ten patients 12-48 h prior to 120 J/cm 2  illumination in trial B. In trial C, 0.1 mg/kg dose was infused to six patients 6 or 12 h prior to 180-270 J/cm 2  illumination. Serum concentrations of photocyanine were measured, and simulations were performed to assess the effect of drug exposure in tissue on responses.
RESULTS


Analysis of photocyanine levels of patients indicated that the two-compartment model best fit the data. Simulations showed that the rates of the drug entering tissues and leaving tissues were equal at 8-12 h after injection. Patients experienced pain which was related to photocyanine serum levels, especially with serum levels above 2500 ng/ml. Fewer non-responders were observed at serum levels higher than 1000 ng/ml for illumination at least 12 h after administration.
CONCLUSION


It is the first report of human trials of photocyanine, and the results suggested that patients receive 180 J/cm 2  illumination about 20-30 min at serum concentrations of photocyanine between 1000 and 2500 ng/ml at least 10 h after administration.",2020,"Fewer non-responders were observed at serum levels higher than 1000 ng/ml for illumination at least 12 h after administration.
","['Twenty-eight cancer patients were enrolled', '12 patients', 'patients with malignancy']","['photocyanine', 'Photodynamic therapy (PDT', 'photocyanine using pharmacokinetics (PK) and pharmacodynamics (PD']","['rates of the drug entering tissues and leaving tissues', 'Serum concentrations of photocyanine']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",28.0,0.0857011,"Fewer non-responders were observed at serum levels higher than 1000 ng/ml for illumination at least 12 h after administration.
","[{'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""State Key Laboratory of Oncology in Southern China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, People's Republic of China.""}, {'ForeName': 'Bingtian', 'Initials': 'B', 'LastName': 'Bi', 'Affiliation': ""State Key Laboratory of Oncology in Southern China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, People's Republic of China.""}, {'ForeName': 'Guangyu', 'Initials': 'G', 'LastName': 'Luo', 'Affiliation': ""State Key Laboratory of Oncology in Southern China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhan', 'Affiliation': ""State Key Laboratory of Oncology in Southern China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, People's Republic of China.""}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ""State Key Laboratory of Oncology in Southern China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, People's Republic of China.""}, {'ForeName': 'Jibin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""State Key Laboratory of Oncology in Southern China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, People's Republic of China.""}, {'ForeName': 'Naisheng', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': ""College of Chemistry, Fuzhou University, Fuzhou, 350108, People's Republic of China.""}, {'ForeName': 'Jinling', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': ""College of Chemistry, Fuzhou University, Fuzhou, 350108, People's Republic of China.""}, {'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Xue', 'Affiliation': ""College of Chemistry, Fuzhou University, Fuzhou, 350108, People's Republic of China. xuejinping66@fzu.edu.cn.""}, {'ForeName': 'Guoliang', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': ""State Key Laboratory of Oncology in Southern China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, People's Republic of China. xugl@sysucc.org.cn.""}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04096-y']
1517,32707226,Cardiovascular changes during peanut-induced allergic reactions in human subjects.,"BACKGROUND


Food allergy is the most common cause of anaphylaxis. Changes in posture during acute reactions can trigger fatal outcomes, but the impact of allergic reactions on the cardiovascular system in nonfatal reactions remains poorly understood.
OBJECTIVE


Our aim was to systematically evaluate changes in cardiovascular function during acute allergic reactions to peanut.
METHODS


Participants underwent double-blind placebo-controlled food challenge to peanut as part of a clinical trial. Changes in hemodynamic parameters (heart rate, stroke volume, blood pressure, and peripheral blood flow) and electrocardiogram findings during food challenges were assessed using noninvasive continuous monitoring.
RESULTS


A total of 57 adults (median age 24 years [interquartile range = 20-29]), 53% of whom were female, participated; 22 (39%) had anaphylaxis. Acute reactions were associated with significant changes in stroke volume (mean decrease of 4.2% [95% CI = 0.8-7.6; P = .03]), heart rate (mean increase 11.6% [95% CI = 8.4-14.8; P < .0001]), and peripheral blood flow (mean increase 19.7% [95% CI = 10.8-28.6; P < .0001]), irrespective of reaction severity. These changes were reproduced at a subsequent repeat peanut challenge in 26 participants, and could be reversed with administration of intravenous fluids which resulted in faster resolution of abdominal symptoms.
CONCLUSIONS


In this first detailed human study of cardiovascular changes during food-induced allergic reactions, we found evidence for significant fluid redistribution, independent of reaction severity. This provides a sound rationale for optimizing venous return during significant allergic reactions to food. Finally, these data provide a new paradigm for understanding severity in anaphylaxis, in which poor outcomes may occur as a result of a failure in compensatory mechanisms.",2020,"mean increase 11.6%, 95%CI 8.4 to 14.8; p<0.0001) and peripheral blood flow (mean increase 19.7%, 95%CI 10.8 to 28.6; p<0.0001), irrespective of reaction severity.","['57 adults (median age 24 (IQR 20-29) years, 53% female) participated; 22 (39%) had anaphylaxis', 'Participants underwent double-blind', 'human subjects']",['placebo'],"['heart rate ', 'Acute reactions', 'hemodynamic parameters (heart rate, stroke volume, blood pressure, peripheral blood flow) and electrocardiogram during food challenges', 'stroke volume', 'cardiovascular function', 'Cardiovascular changes', 'peripheral blood flow']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0425710', 'cui_str': 'Peripheral blood flow'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular function'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",57.0,0.414272,"mean increase 11.6%, 95%CI 8.4 to 14.8; p<0.0001) and peripheral blood flow (mean increase 19.7%, 95%CI 10.8 to 28.6; p<0.0001), irrespective of reaction severity.","[{'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Ruiz-Garcia', 'Affiliation': 'Section of Inflammation, Repair and Development, National Heart & Lung Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Bartra', 'Affiliation': 'Section of Inflammation, Repair and Development, National Heart & Lung Institute, Imperial College London, London, United Kingdom; Hospital Clínic Barcelona, Barcelona, Spain.'}, {'ForeName': 'Olaya', 'Initials': 'O', 'LastName': 'Alvarez', 'Affiliation': 'Section of Inflammation, Repair and Development, National Heart & Lung Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Ashna', 'Initials': 'A', 'LastName': 'Lakhani', 'Affiliation': 'Section of Inflammation, Repair and Development, National Heart & Lung Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Shalinee', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Section of Inflammation, Repair and Development, National Heart & Lung Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'Section of Inflammation, Repair and Development, National Heart & Lung Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Sim', 'Affiliation': 'Section of Inflammation, Repair and Development, National Heart & Lung Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Mohamed H', 'Initials': 'MH', 'LastName': 'Shamji', 'Affiliation': 'Section of Inflammation, Repair and Development, National Heart & Lung Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Skypala', 'Affiliation': 'Section of Inflammation, Repair and Development, National Heart & Lung Institute, Imperial College London, London, United Kingdom; Royal Brompton and Harefield Hospitals NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'E N Clare', 'Initials': 'ENC', 'LastName': 'Mills', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Alexander R', 'Initials': 'AR', 'LastName': 'Lyon', 'Affiliation': 'Myocardial Function, National Heart & Lung Institute, Imperial College London, London, United Kingdom; Cardiology Department, Royal Brompton and Harefield Hospitals NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Hayward', 'Affiliation': 'Myocardial Function, National Heart & Lung Institute, Imperial College London, London, United Kingdom; Cardiology Department, Royal Brompton and Harefield Hospitals NHS Foundation Trust, London, United Kingdom; Barts Health NHS Trust, London, United Kingdom.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Durham', 'Affiliation': 'Section of Inflammation, Repair and Development, National Heart & Lung Institute, Imperial College London, London, United Kingdom; Royal Brompton and Harefield Hospitals NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Turner', 'Affiliation': 'Section of Inflammation, Repair and Development, National Heart & Lung Institute, Imperial College London, London, United Kingdom. Electronic address: p.turner@imperial.ac.uk.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Boyle', 'Affiliation': 'Section of Inflammation, Repair and Development, National Heart & Lung Institute, Imperial College London, London, United Kingdom.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.06.033']
1518,32707294,Effects of stress on 6- and 7-year-old children's emotional memory differs by gender.,"Understanding effects of emotional valence and stress on children's memory is important for educational and legal contexts. This study disentangled the effects of emotional content of to-be-remembered information (i.e., items differing in emotional valence and arousal), stress exposure, and associated cortisol secretion on children's memory. We also examined whether girls' memory is more affected by stress induction. A total of 143 6- and 7-year-old children were randomly allocated to the Trier Social Stress Test for Children (n = 103) or a control condition (n = 40). At 25 min after stressor onset, children incidentally encoded 75 objects varying in emotional valence (crossed with arousal) together with neutral scene backgrounds. We found that response bias corrected memory was worse for low-arousing negative items than for neutral and positive items, with the latter two categories not being different from each other. Whereas boys' memory was largely unaffected by stress, girls in the stress condition showed worse memory for negative items, especially the low-arousing ones, than girls in the control condition. Girls, compared with boys, reported higher subjective stress increases following stress exposure and had higher cortisol stress responses. Whereas a higher cortisol stress response was associated with better emotional memory in girls in the stress condition, boys' memory was not associated with their cortisol secretion. Taken together, our study suggests that 6- and 7-year-old children, more so girls, show memory suppression for negative information. Girls' memory for negative information, compared with that of boys, is also more strongly modulated by stress experience and the associated cortisol response.",2020,A total of 143 6- and 7-year-old children were randomly allocated to the Trier Social Stress Test for Children (n = 103) or a control condition (n = 40).,"[""6- and 7-year-old children's emotional memory differs by gender"", 'A total of 143 6- and 7-year-old children', ""children's memory""]",['Trier Social Stress Test for Children (n\xa0=\xa0103) or a control condition'],"['cortisol response', 'cortisol stress responses', 'cortisol stress response']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517573', 'cui_str': '143'}]","[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",143.0,0.0372713,A total of 143 6- and 7-year-old children were randomly allocated to the Trier Social Stress Test for Children (n = 103) or a control condition (n = 40).,"[{'ForeName': 'Laurel', 'Initials': 'L', 'LastName': 'Raffington', 'Affiliation': 'Center for Lifespan Psychology, Max Planck Institute for Human Development, 14195 Berlin, Germany; Department of Psychology, University of Texas at Austin, Austin, TX 78712, USA.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Falck', 'Affiliation': 'Center for Lifespan Psychology, Max Planck Institute for Human Development, 14195 Berlin, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Heim', 'Affiliation': 'Institute of Medical Psychology, Charité - Universitäts medizin Berlin, 10117 Berlin, Germany; Department of Biobehavioral Health, Pennsylvania State University, University Park, PA 16802, USA.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Mather', 'Affiliation': 'Leonard Davis School of Gerontology, University of Southern California, Los Angeles, CA 90089, USA.'}, {'ForeName': 'Yee Lee', 'Initials': 'YL', 'LastName': 'Shing', 'Affiliation': 'Center for Lifespan Psychology, Max Planck Institute for Human Development, 14195 Berlin, Germany; Institute of Psychology, Goethe-Universität Frankfurt, 60323 Frankfurt am Main, Germany. Electronic address: shing@psych.uni-frankfurt.de.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2020.104924']
1519,32707332,An invited commentary: The efficacy of transversus abdominis plane block with or without dexmedetomidine for postoperative analgesia in renal transplantation. A randomized controlled trial.,,2020,,['renal transplantation'],['transversus abdominis plane block with or without dexmedetomidine'],[],"[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]",[],,0.168804,,"[{'ForeName': 'Yuhang', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University, Guizhou, 563000, China. Electronic address: yulang5301@sina.com.'}, {'ForeName': 'Taowu', 'Initials': 'T', 'LastName': 'Gong', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University, Guizhou, 563000, China. Electronic address: chenmingaini1232@sina.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.07.008']
1520,32710888,Effects of Ramadan intermittent fasting on inflammatory and biochemical biomarkers in males with obesity.,"BACKGROUND


To determine the effects of Ramadan intermittent fasting (RIF) on inflammatory (C-reactive protein (CRP), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α)) and biochemical markers of liver-renal function (aspartate aminotransferase (AST), alanine amino transferase (ALT), bilirubin, lactate dehydrogenase (LDH), urea and creatinine) in males with obesity.
MATERIALS AND METHODS


Twenty-eight males with obesity were randomly allocated to an experimental group (EG, n = 14) or a control group (CG, n = 14). The EG group completed their fasting rituals for the entire month of Ramadan (30 days) whereas the CG group continued with their normal daily habits. Blood samples were collected 24 h before the start of Ramadan (T0), on the 15th day of Ramadan (T1), the day after the end of Ramadan (T2), and 21 days after the end of Ramadan (T3). Resting plasma volume variation between pre and post-RIF (ΔPV) was calculated.
RESULTS


Decreases were noted for interleukin-6 (p = 0.02, d = 1.4) and tumor necrosis factor-alpha (p = 0.01, d = 0.7), with no changes for C-reactive protein (p = 0.3; d = 0.1) in the EG compared to CG group. There were no changes (P > 0.05) in ΔPV recorded after RIF for either EG (-0.035 ± 0.02%) and CG (0.055 ± 0.06%).
CONCLUSION


This study demonstrates that RIF improves systemic inflammation biomarkers in males with obesity. Moreover, RIF did not negatively affect biomarkers of liver and renal function.",2020,"RESULTS


Decreases were noted for interleukin-6 (p = 0.02, d = 1.4) and tumor necrosis factor-alpha (p = 0.01, d = 0.7), with no changes for C-reactive protein (p = 0.3; d=0.1) in the EG compared to CG group.","['males with obesity', 'Twenty-eight males with obesity']","['Ramadan intermittent fasting', 'Ramadan intermittent fasting (RIF', 'RIF']","['systemic inflammation biomarkers', 'inflammatory (C-reactive protein (CRP), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α)) and biochemical markers of liver-renal function (aspartate aminotransferase (AST), alanine amino transferase (ALT), bilirubin, lactate dehydrogenase (LDH), urea and creatinine', 'Blood samples', 'biomarkers of liver and renal function', 'inflammatory and biochemical biomarkers', 'tumor necrosis factor-alpha']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C4704881', 'cui_str': 'Intermittent Fasting'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0057041', 'cui_str': 'D-amino-acid transaminase'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}]",28.0,0.0245917,"RESULTS


Decreases were noted for interleukin-6 (p = 0.02, d = 1.4) and tumor necrosis factor-alpha (p = 0.01, d = 0.7), with no changes for C-reactive protein (p = 0.3; d=0.1) in the EG compared to CG group.","[{'ForeName': 'Hassane', 'Initials': 'H', 'LastName': 'Zouhal', 'Affiliation': 'Univ Rennes, M2S (Laboratoire Mouvement, Sport, Santé) - EA 1274, F-35000 Rennes, France. Electronic address: hassane.zouhal@univ-rennes2.fr.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Damoon', 'Initials': 'D', 'LastName': 'Ashtary-Larky', 'Affiliation': 'Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, USA.'}, {'ForeName': 'Raoua', 'Initials': 'R', 'LastName': 'Triki', 'Affiliation': 'ISSEP Ksar Said, University of Manouba, Tunis, Tunisia.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Hackney', 'Affiliation': 'Department of Exercise & Sport Science, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Laher', 'Affiliation': 'Department of Anesthesiology, Pharmacology and Therapeutics, The University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Abderraouf Ben', 'Initials': 'AB', 'LastName': 'Abderrahman', 'Affiliation': 'ISSEP Ksar Said, University of Manouba, Tunis, Tunisia.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113090']
1521,32640131,A Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries.,"BACKGROUND


Injuries from falls are major contributors to complications and death in older adults. Despite evidence from efficacy trials that many falls can be prevented, rates of falls resulting in injury have not declined.
METHODS


We conducted a pragmatic, cluster-randomized trial to evaluate the effectiveness of a multifactorial intervention that included risk assessment and individualized plans, administered by specially trained nurses, to prevent fall injuries. A total of 86 primary care practices across 10 health care systems were randomly assigned to the intervention or to enhanced usual care (the control) (43 practices each). The participants were community-dwelling adults, 70 years of age or older, who were at increased risk for fall injuries. The primary outcome, assessed in a time-to-event analysis, was the first serious fall injury, adjudicated with the use of participant report, electronic health records, and claims data. We hypothesized that the event rate would be lower by 20% in the intervention group than in the control group.
RESULTS


The demographic and baseline characteristics of the participants were similar in the intervention group (2802 participants) and the control group (2649 participants); the mean age was 80 years, and 62.0% of the participants were women. The rate of a first adjudicated serious fall injury did not differ significantly between the groups, as assessed in a time-to-first-event analysis (events per 100 person-years of follow-up, 4.9 in the intervention group and 5.3 in the control group; hazard ratio, 0.92; 95% confidence interval [CI], 0.80 to 1.06; P = 0.25). The rate of a first participant-reported fall injury was 25.6 events per 100 person-years of follow-up in the intervention group and 28.6 events per 100 person-years of follow-up in the control group (hazard ratio, 0.90; 95% CI, 0.83 to 0.99; P = 0.004). The rates of hospitalization or death were similar in the two groups.
CONCLUSIONS


A multifactorial intervention, administered by nurses, did not result in a significantly lower rate of a first adjudicated serious fall injury than enhanced usual care. (Funded by the Patient-Centered Outcomes Research Institute and others; STRIDE ClinicalTrials.gov number, NCT02475850.).",2020,A total of 86 primary care practices across 10 health care systems were randomly assigned to the intervention or to enhanced usual care (the control) (43 practices each).,"['participants were similar in the intervention group (2802 participants) and the control group (2649 participants); the mean age was 80 years, and 62.0% of the participants were women', '86 primary care practices across 10 health care systems', 'older adults', 'participants were community-dwelling adults, 70 years of age or older, who were at increased risk for fall injuries']","['multifactorial intervention', 'intervention or to enhanced usual care (the control']","['time-to-event analysis, was the first serious fall injury, adjudicated with the use of participant report, electronic health records, and claims data', 'rate of a first adjudicated serious fall injury', 'rate of a first participant-reported fall injury', 'rates of hospitalization or death']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0051533', 'cui_str': 'Am 80'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0085639', 'cui_str': 'Falls'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",2802.0,0.136147,A total of 86 primary care practices across 10 health care systems were randomly assigned to the intervention or to enhanced usual care (the control) (43 practices each).,"[{'ForeName': 'Shalender', 'Initials': 'S', 'LastName': 'Bhasin', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Gill', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Reuben', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Nancy K', 'Initials': 'NK', 'LastName': 'Latham', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ganz', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Erich J', 'Initials': 'EJ', 'LastName': 'Greene', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dziura', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Shehzad', 'Initials': 'S', 'LastName': 'Basaria', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Jerry H', 'Initials': 'JH', 'LastName': 'Gurwitz', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Patricia C', 'Initials': 'PC', 'LastName': 'Dykes', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'McMahon', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Storer', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Gazarian', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Miller', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Travison', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Esserman', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Martha B', 'Initials': 'MB', 'LastName': 'Carnie', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Goehring', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Fagan', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Greenspan', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Alexander', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Wiggins', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Ko', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Albert L', 'Initials': 'AL', 'LastName': 'Siu', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Volpi', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Albert W', 'Initials': 'AW', 'LastName': 'Wu', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Rich', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Waring', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Wallace', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Carri', 'Initials': 'C', 'LastName': 'Casteel', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Resnick', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Magaziner', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Charpentier', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Araujo', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Haseena', 'Initials': 'H', 'LastName': 'Rajeevan', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Meng', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Allore', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Brooke F', 'Initials': 'BF', 'LastName': 'Brawley', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Rich', 'Initials': 'R', 'LastName': 'Eder', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'McGloin', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Eleni A', 'Initials': 'EA', 'LastName': 'Skokos', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Pamela W', 'Initials': 'PW', 'LastName': 'Duncan', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Baker', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Boult', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Rosaly', 'Initials': 'R', 'LastName': 'Correa-de-Araujo', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Peduzzi', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2002183']
1522,32640286,Deconstructing the effects of concentration meditation practice on interference control: The roles of controlled attention and inflammatory activity.,"Prior work has linked meditation practice to improvements in interference control. However, the mechanisms underlying these improvements are relatively unknown. In the context of meditation training, improvements in interference control could result eitherfrom increases in controlled attention to goal-relevant stimuli, or from reductions in automatic capture by goal-irrelevant stimuli. Moreover, few studies have linked training-related changes in attention to physiological processes, such as inflammatory activity, that are thought to influence cognitive function. This study addresses these gaps by examining associations between cognitive performance and cytokines in the context of an intensive meditation retreat. Participants were randomly assigned to complete 3 months of meditation training first, or to serve as waitlist controls. The waitlist-control participants then later completed a separate 3-month training intervention. We assessed participants' interference control with a flanker task and used computational modeling to derive component processes of controlled and automatic attention. We also collected blood samples at the beginning, middle, and end of training to quantify changes in cytokine activity. Participants who completed training evidenced better controlled attention than waitlist controls during the first retreat intervention, and controls showed significant improvements in controlled attention when they completed their own, second retreat. Importantly, inflammatory activity was inversely associated with controlled attention during both interventions. Our results suggest that practice of concentration meditation influences interference control by enhancing controlled attention to goal-relevant task elements, and that inflammatory activity relates to individual differences in controlled attention.",2020,"Participants who completed training evidenced better controlled attention than waitlist controls during the first retreat intervention, and controls showed significant improvements in controlled attention when they completed their own, second retreat.",[],"['concentration meditation practice', 'concentration meditation', 'meditation training', 'meditation training first, or to serve as waiting-list controls']","['inflammatory activity', 'interference control']",[],"[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0134664,"Participants who completed training evidenced better controlled attention than waitlist controls during the first retreat intervention, and controls showed significant improvements in controlled attention when they completed their own, second retreat.","[{'ForeName': 'Grant S', 'Initials': 'GS', 'LastName': 'Shields', 'Affiliation': 'Department of Psychological Science, University of Arkansas, Fayetteville, AR, USA. Electronic address: gshields@uark.edu.'}, {'ForeName': 'Alea C', 'Initials': 'AC', 'LastName': 'Skwara', 'Affiliation': 'Center for Mind and Brain, University of California, Davis, CA, USA; Department of Psychology, University of California, Davis, CA, USA.'}, {'ForeName': 'Brandon G', 'Initials': 'BG', 'LastName': 'King', 'Affiliation': 'Center for Mind and Brain, University of California, Davis, CA, USA.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Zanesco', 'Affiliation': 'Department of Psychology, University of Miami, Coral Gables, FL, USA.'}, {'ForeName': 'Firdaus S', 'Initials': 'FS', 'LastName': 'Dhabhar', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Department of Microbiology & Immunology, and The Sylvester Comprehensive Cancer Center, Miller School of Medicine, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Clifford D', 'Initials': 'CD', 'LastName': 'Saron', 'Affiliation': 'Center for Mind and Brain, University of California, Davis, CA, USA. Electronic address: cdsaron@ucdavis.edu.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2020.06.034']
1523,32681460,Reduced Hypoglycemia Risk in Type 2 Diabetes Patients Switched to/Initiating Insulin Glargine 300 vs 100 U/ml: A European Real-World Study.,"INTRODUCTION


Randomized controlled trials and real-world data from the USA have shown similar glycemic control with insulin glargine 300 U/ml (Gla-300) and insulin glargine 100 U/ml (Gla-100) and reduced hypoglycemia risk with Gla-300. This real-world study describes the efficacy and safety of Gla-300 and Gla-100 in patients with type 2 diabetes (T2D) in France, Spain, and Germany.
METHODS


This retrospective chart review analysis used anonymized data for adults with T2D switching basal insulin analog (BIA) therapy to Gla-300 or Gla-100, or insulin-naïve patients initiating Gla-300 or Gla-100. Outcomes included change from baseline to 6-month follow-up in glycated hemoglobin A1c (A1C), total and severe hypoglycemia incidences and events, insulin dose, and reasons for BIA choice.
RESULTS


Six hundred sixty-five physicians (33.8% Spain, 31.7% France, 34.4% Germany) provided chart data for patients switching to Gla-300 (n = 679) or Gla-100 (n = 429) or initiating Gla-300 (n = 719) or Gla-100 (n = 711). After adjustment for baseline characteristics, A1C reductions from baseline were similar for patients switching to Gla-300 or Gla-100 (- 0.87% vs. - 0.93%; p = 0.326) while those switched to Gla-300 vs. Gla-100 had a significantly greater mean reduction in hypoglycemic events (- 1.29 vs. - 0.81 events during 6 months; p = 0.012). Mean insulin doses after titration were 0.43 ± 0.36 and 0.40 ± 0.28 U/kg in Gla-300 and Gla-100 switchers, respectively. Factors that significantly influenced BIA choice included a lower risk of hypoglycemia (for Gla-300) and physician familiarity (for Gla-100). Outcomes for insulin-naïve patients were broadly similar to those of switchers.
CONCLUSIONS


In this real-world European study, patients with T2D who switched therapy to Gla-300 or Gla-100 had improved glycemic control and reduced hypoglycemia at 6 months, with significant hypoglycemia advantages with Gla-300.",2020,"Outcomes for insulin-naïve patients were broadly similar to those of switchers.
","['Six hundred sixty-five physicians', '300 vs 100 U', 'adults with T2D switching basal insulin analog (BIA) therapy to Gla-300 or Gla-100, or insulin-naïve patients initiating Gla-300 or Gla-100', 'patients with type 2 diabetes (T2D) in France, Spain, and Germany']","['Gla-300 and Gla-100', 'Insulin Glargine']","['glycated hemoglobin A1c (A1C), total and severe hypoglycemia incidences and events, insulin dose, and reasons for BIA choice', 'risk of hypoglycemia (for Gla-300) and physician familiarity (for Gla-100', 'Hypoglycemia Risk', 'Mean insulin doses', 'glycemic control and reduced hypoglycemia', 'hypoglycemic events', 'hypoglycemia risk']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}]",,0.0204853,"Outcomes for insulin-naïve patients were broadly similar to those of switchers.
","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escalada', 'Affiliation': 'Clinic University of Navarra, Pamplona, Spain. fjavier.escalada@gmail.com.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Bonnet', 'Affiliation': 'CHU de Rennes, Université Rennes 1, Rennes, France.'}, {'ForeName': 'Jasmanda', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Bonnemaire', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Shaloo', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Kantar, New York, NY, USA.'}, {'ForeName': 'Janelle M', 'Initials': 'JM', 'LastName': 'Cambron-Mellott', 'Affiliation': 'Kantar, New York, NY, USA.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Nicholls', 'Affiliation': 'Sanofi, Reading, UK.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Müller-Wieland', 'Affiliation': 'Department of Medicine, University Hospital Aachen, Aachen, Germany.'}]",Advances in therapy,['10.1007/s12325-020-01436-5']
1524,32681461,"The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP3652 in First-in-Human and Ascending Multiple Oral Dose Studies in Healthy Subjects.","INTRODUCTION


Inhibitors of fatty acid amide hydrolase (FAAH) increase the levels of endocannabinoids and have shown analgesic and anti-inflammatory activity in animal models. ASP3652 is a peripherally acting FAAH inhibitor in development for the treatment of chronic bladder and pelvic pain disorders. Here we describe the safety, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of ASP3652 administered in healthy non-elderly and elderly male and female volunteers.
METHODS


Study 1 was a combined single-ascending dose and food-effect study in which ASP3652 was given as single doses (1-600 mg) or matching placebo in healthy subjects. Study 2 was a multiple ascending dose study in which ASP3652 or matching placebo was administered in multiple oral doses (10-300 mg bid and 600 mg qd for 14 days) to healthy subjects. In both studies, the levels of ASP3652, FAAH, endocannabinoids (eCBs) and safety were evaluated.
RESULTS


ASP3652 was readily absorbed to reach C max  at 1 h after a single dose. Steady state was reached within 3 days after the start of multiple dosing. The C max  and AUC of ASP3652 increased in a slightly more than dose-proportional manner after a single dose of ASP3652 at 30-600 mg. There was some accumulation (15-38%) based on C max  and AUC 12h  upon multiple doses. C max  was 47% lower in combination with food. There was no significant effect of gender or age on the pharmacokinetics of ASP3652. FAAH activity was inhibited in a dose-dependent manner in all dose groups after single and multiple doses of ASP3652, paralleled by an increase in plasma levels of anandamide (AEA). The incidence of adverse events following multiple doses was similar across all treatment groups including the placebo group.
CONCLUSIONS


Single and multiple doses of ASP3652 were safe and well tolerated and increased endogenous cannabinoid plasma levels.",2020,"FAAH activity was inhibited in a dose-dependent manner in all dose groups after single and multiple doses of ASP3652, paralleled by an increase in plasma levels of anandamide (AEA).","['healthy subjects', 'Healthy Subjects', 'healthy non-elderly and elderly male and female volunteers']","['placebo', 'ASP3652', 'matching placebo', 'ASP3652 or matching placebo']","['Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP3652', 'plasma levels of anandamide (AEA', 'safe and well tolerated and increased endogenous cannabinoid plasma levels', 'FAAH activity', 'Steady state', 'levels of ASP3652, FAAH, endocannabinoids (eCBs) and safety', 'adverse events', 'C max  and AUC of ASP3652']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0211726', 'cui_str': 'anandamide'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1172779', 'cui_str': 'Endocannabinoid'}, {'cui': 'C0531004', 'cui_str': 'fatty acid amide hydrolase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",,0.0491394,"FAAH activity was inhibited in a dose-dependent manner in all dose groups after single and multiple doses of ASP3652, paralleled by an increase in plasma levels of anandamide (AEA).","[{'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Takizawa', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan. masaomi.takizawa@astellas.com.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Cerneus', 'Affiliation': 'Astellas Pharma Europe B. V., Leiden, The Netherlands.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Michon', 'Affiliation': 'Astellas Pharma Europe B. V., Leiden, The Netherlands.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Rijnders', 'Affiliation': 'Astellas Pharma Europe B. V., Leiden, The Netherlands.'}, {'ForeName': 'Desiree', 'Initials': 'D', 'LastName': 'van der Heide', 'Affiliation': 'Astellas Pharma Europe B. V., Leiden, The Netherlands.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Meijer', 'Affiliation': 'Astellas Pharma Europe B. V., Leiden, The Netherlands.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Stoelzel', 'Affiliation': 'Astellas Pharma Europe B. V., Leiden, The Netherlands.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Astellas Pharma Inc., Ibaraki, Japan.'}]",Advances in therapy,['10.1007/s12325-020-01402-1']
1525,32686972,Text message-based lifestyle intervention in primary care patients with hypertension: a randomized controlled pilot trial.,"OBJECTIVE


To evaluate the feasibility of a randomized controlled pilot study with lifestyle-promoting text messages as a treatment for hypertension in primary care.
DESIGN


Randomized controlled pilot trial.
SETTING


Three primary health care centers in southern Sweden.
SUBJECTS


Sixty patients aged 40-80 years with hypertension were included.
MAIN OUTCOME MEASURES


Feasibility of the pilot study, i.e. recruitment rate, dropout rate and eligibility criteria. Secondary outcomes were change in blood pressure and other cardiovascular risk factors.
METHODS


Thirty participants were randomized to the intervention group with four lifestyle-promoting text messages sent every week for six months. The control group received usual care. The baseline and follow-up visits for all 60 patients included measurements of blood pressure, anthropometrics, blood tests and a self-reported questionnaire.
RESULTS


All feasibility criteria (recruitment rate (≥55%), dropout rate (≤15%) and eligibility (60 eligible patients during the four-month inclusion period) for the pilot study were fulfilled. This means that a larger study with a similar design may be conducted. After six months, there were no significant improvements in cardiovascular risk factors. However, we found favorable trends for all secondary outcomes in the intervention group as compared to the control group.
CONCLUSION


Lifestyle modification in patients with hypertension is important to reduce cardiovascular risk. However, primary healthcare has limited resources to work with modifying lifestyle habits. This is the first pilot study to test the feasibility of text message-based lifestyle intervention in patients with hypertension in Swedish primary healthcare. Whether significant improvement in cardiovascular risk factors may be achieved in a larger study population remains to be evaluated. Key points This pilot randomized controlled trial (RCT) is the first study to evaluate the feasibility of text message-based lifestyle advice to patients with hypertension in Swedish primary healthcare. •All feasibility criteria for the pilot study were fulfilled. This outcome means that a larger study with a similar design may be conducted. •The study was not powered to find significant changes in cardiovascular risk factors. Nevertheless, after six months we found favorable trends for all secondary outcomes in the intervention group compared to control. •If a future larger study can show significant results, this intervention could serve as a useful tool in everyday primary healthcare.",2020,"After six months, there were no significant improvements in cardiovascular risk factors.","['primary care patients with hypertension', 'hypertension in primary care', 'Sixty patients aged 40-80\u2009years with hypertension were included', 'patients with hypertension', 'patients with hypertension in Swedish primary healthcare', 'Three primary health care centers in southern Sweden', 'Thirty participants']","['text message-based lifestyle advice', 'text message-based lifestyle intervention', 'usual care', 'lifestyle-promoting text messages', 'Text message-based lifestyle intervention']","['dropout rate', 'blood pressure, anthropometrics, blood tests and a self-reported questionnaire', 'blood pressure and other cardiovascular risk factors', 'cardiovascular risk factors']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",30.0,0.0772197,"After six months, there were no significant improvements in cardiovascular risk factors.","[{'ForeName': 'Beata Borgström', 'Initials': 'BB', 'LastName': 'Bolmsjö', 'Affiliation': 'Department of Clinical Sciences Malmö, Lund University, Sweden.'}, {'ForeName': 'Moa', 'Initials': 'M', 'LastName': 'Wolff', 'Affiliation': 'Department of Clinical Sciences Malmö, Lund University, Sweden.'}, {'ForeName': 'Veronica Milos', 'Initials': 'VM', 'LastName': 'Nymberg', 'Affiliation': 'Department of Clinical Sciences Malmö, Lund University, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Sandberg', 'Affiliation': 'Department of Health Sciences, Lund University, Sweden.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Midlöv', 'Affiliation': 'Department of Clinical Sciences Malmö, Lund University, Sweden.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Calling', 'Affiliation': 'Department of Clinical Sciences Malmö, Lund University, Sweden.'}]",Scandinavian journal of primary health care,['10.1080/02813432.2020.1794392']
1526,32682735,Effect of an Informative Video on Anxiety and Hemodynamic Parameters in Patients Requiring Mandibular Third Molar Extraction: A Randomized Clinical Trial.,"PURPOSE


The purpose was to determine the effect of watching an informative video about mandibular third molar (M3M) removal on patient anxiety and hemodynamic parameters.
PATIENTS AND METHODS


A randomized controlled clinical trial was carried out in healthy patients (aged between 18 and 40 years) requiring M3M extraction under local anesthesia. Patients with previous tooth extractions, psychiatric disorders, or cardiac problems or patients undergoing anxiolytic or antidepressant drug treatment were excluded. Participants were randomized into 2 groups according to whether they watched an informative video about the surgical procedure (video group) or not (control group). The primary outcome variable was the difference between groups regarding patient anxiety assessed with the State-Trait Anxiety Inventory (STAI) and the Modified Dental Anxiety Scale (MDAS). The secondary outcome variables were hemodynamic parameters recorded during different moments of the surgical procedure. Descriptive, bivariate, and multivariate analyses were performed, and a repeated-measures mixed model was generated. Statistical significance was considered for P < .05.
RESULTS


Fifty patients referred for M3M extraction met the inclusion criteria. The final data analysis was based on 47 patients: 25 from the video group and 22 controls. The bivariate analysis showed the video group to have a significant decrease in anxiety as measured by the MDAS (P = .006; 95% confidence interval [CI], -4.1 to -0.7) and STAI-State (P = .003; 95% CI, -13.7 to -0.7). A significantly lower heart rate was likewise found in the video group (χ 2  = 4.30, df = 1, P = .038). The linear regression analysis adjusting for the STAI-Trait also showed lower dental anxiety measured by the MDAS in the video group (P = .023; 95% CI, 0.32 to 4.14).
CONCLUSIONS


Providing preoperative information through an informative video about M3M removal significantly reduces patient anxiety and heart rate during the surgical procedure.",2020,"A significantly lower heart rate was likewise found in the video group (χ 2  = 4.30, df = 1, P = .038).","['47 patients: 25 from the video group and 22 controls', 'Patients Requiring Mandibular Third Molar Extraction', 'Fifty patients referred for M3M extraction met the inclusion criteria', 'healthy patients (aged between 18 and 40\xa0years) requiring M3M extraction under local anesthesia', 'Patients with previous tooth extractions, psychiatric disorders, or cardiac problems or patients undergoing anxiolytic or antidepressant drug treatment were excluded']","['informative video about the surgical procedure (video group) or not (control group', 'watching an informative video about mandibular third molar (M3M) removal', 'Informative Video']","['patient anxiety and heart rate', 'anxiety', 'hemodynamic parameters recorded during different moments of the surgical procedure', 'Anxiety and Hemodynamic Parameters', 'dental anxiety', 'heart rate', 'patient anxiety assessed with the State-Trait Anxiety Inventory (STAI) and the Modified Dental Anxiety Scale (MDAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0040616', 'cui_str': 'Anxiolytic agent'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0085380', 'cui_str': 'Dental phobia'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",50.0,0.095681,"A significantly lower heart rate was likewise found in the video group (χ 2  = 4.30, df = 1, P = .038).","[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Toledano-Serrabona', 'Affiliation': 'Fellow of the Master Degree of Oral Surgery and Implantology, School of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Sánchez-Torres', 'Affiliation': 'Associate Professor of Oral Surgery, Master Degree Program in Oral Surgery and Implantology, School of Medicine and Health Sciences, University of Barcelona; and Researcher at IDIBELL (Bellvitge Biomedical Research Institute), Barcelona, Spain.'}, {'ForeName': 'Octavi', 'Initials': 'O', 'LastName': 'Camps-Font', 'Affiliation': 'Associate Professor of Oral Surgery, Master Degree Program in Oral Surgery and Implantology, School of Medicine and Health Sciences, University of Barcelona; and Researcher at IDIBELL (Bellvitge Biomedical Research Institute), Barcelona, Spain.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Figueiredo', 'Affiliation': 'Lecturer in Oral Surgery and Coordinator of the Master Degree Program in Oral Surgery and Implantology, School of Medicine and Health Sciences, University of Barcelona; and Researcher at IDIBELL (Bellvitge Biomedical Research Institute), Barcelona, Spain. Electronic address: ruipfigueiredo@hotmail.com.'}, {'ForeName': 'Cosme', 'Initials': 'C', 'LastName': 'Gay-Escoda', 'Affiliation': 'Chairman and Professor of Oral and Maxillofacial Surgery, School of Medicine and Health Sciences, University of Barcelona; Director of the Master Degree Program in Oral Surgery and Implantology, EFHRE International University/FUCSO (Fundacio Catalana per a la Salut Oral); Coordinator/Researcher at IDIBELL (Bellvitge Biomedical Research Institute); and Head of the Oral Surgery, Implantology and Maxillofacial Surgery Department, Teknon Medical Center, Barcelona, Spain.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Valmaseda-Castellón', 'Affiliation': 'Senior Lecturer in Oral Surgery and Director of the Master Degree Program in Oral Surgery and Implantology, School of Medicine and Health Sciences, University of Barcelona; and Researcher at IDIBELL (Bellvitge Biomedical Research Institute), Barcelona, Spain.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.06.024']
1527,32697288,Dialectical Behavior Therapy for Posttraumatic Stress Disorder (DBT-PTSD) Compared With Cognitive Processing Therapy (CPT) in Complex Presentations of PTSD in Women Survivors of Childhood Abuse: A Randomized Clinical Trial.,"Importance


Childhood abuse significantly increases the risk of developing posttraumatic stress disorder (PTSD), often accompanied by symptoms of borderline personality disorder (BPD) and other co-occurring mental disorders. Despite the high prevalence, systematic evaluations of evidence-based treatments for PTSD after childhood abuse are sparse.
Objective


To compare the efficacy of dialectical behavior therapy for PTSD (DBT-PTSD), a new, specifically designed, phase-based treatment program, against that of cognitive processing therapy (CPT), one of the best empirically supported treatments for PTSD.
Design, Setting, and Participants


From January 2014 to October 2016, women who sought treatment were included in a multicenter randomized clinical trial with blinded outcome assessments at 3 German university outpatient clinics. The participants were prospectively observed for 15 months. Women with childhood abuse-associated PTSD who additionally met 3 or more DSM-5 criteria for BPD, including affective instability, were included. Data analysis took place from October 2018 to December 2019.
Interventions


Participants received equal dosages and frequencies of DBT-PTSD or CPT, up to 45 individual sessions within 1 year and 3 additional sessions during the following 3 months.
Main Outcomes and Measures


The predefined primary outcome was the course of the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score from randomization to month 15. Intent-to-treat analyses based on dimensional CAPS-5 scores were complemented by categorical outcome measures assessing symptomatic remission, reliable improvement, and reliable recovery.
Results


Of 955 consecutive individuals assessed for eligibility, 193 were randomized (DBT-PTSD, 98; CPT, 95; mean [SD] age, 36.3 [11.1] years) and included in the intent-to-treat analyses. Analysis revealed significantly improved CAPS-5 scores in both groups (effect sizes: DBT-PTSD: d, 1.35; CPT: d, 0.98) and a small but statistically significant superiority of DBT-PTSD (group difference: 4.82 [95% CI, 0.67-8.96]; P = .02; d, 0.33). Compared with the CPT group, participants in the DBT-PTSD group were less likely to drop out early (37 [39.0%] vs 25 [25.5%]; P = .046) and had higher rates of symptomatic remission (35 [40.7%] vs 52 [58.4%]; P = .02), reliable improvement (53 [55.8%] vs 73 [74.5%]; P = .006), and reliable recovery (34 [38.6%] vs 52 [57.1%]; P = .01).
Conclusions and Relevance


These findings support the efficacy of DBT-PTSD and CPT in the treatment of women with childhood abuse-associated complex PTSD. Results pertaining to the primary outcomes favored DBT-PTSD. The study shows that even severe childhood abuse-associated PTSD with emotion dysregulation can be treated efficaciously.
Trial Registration


German Clinical Trials Register: DRKS00005578.",2020,"Analysis revealed significantly improved CAPS-5 scores in both groups (effect sizes: DBT-PTSD: d, 1.35; CPT: d, 0.98) and a small but statistically significant superiority of DBT-PTSD (group difference: 4.82 [95% CI, 0.67-8.96]; P = .02; d, 0.33).","['women with childhood abuse-associated complex PTSD', 'Posttraumatic Stress Disorder (DBT-PTSD', 'From January 2014 to October 2016, women who sought treatment were included in a multicenter randomized clinical trial with blinded outcome assessments at 3 German university outpatient clinics', '955 consecutive individuals assessed for eligibility, 193 were randomized (DBT-PTSD, 98', 'Women Survivors of Childhood Abuse', 'Women with childhood abuse-associated PTSD who additionally met 3 or more DSM-5 criteria for BPD, including affective instability, were included']","['DBT-PTSD and CPT', 'CPT', 'Dialectical Behavior Therapy', 'DBT-PTSD or CPT', 'cognitive processing therapy (CPT', 'dialectical behavior therapy', 'Cognitive Processing Therapy (CPT']","['CAPS-5 scores', 'DBT-PTSD', 'symptomatic remission, reliable improvement, and reliable recovery', 'rates of symptomatic remission', 'course of the Clinician-Administered PTSD Scale for DSM-5', 'dimensional CAPS-5 scores', 'reliable recovery']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C2733207', 'cui_str': 'Complex posttraumatic stress disorder'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C3472347', 'cui_str': 'Digital breast tomosynthesis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0085565', 'cui_str': 'Outcome Assessment (Health Care)'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}]","[{'cui': 'C3472347', 'cui_str': 'Digital breast tomosynthesis'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1321145', 'cui_str': 'Dialectical behavior therapy'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3472347', 'cui_str': 'Digital breast tomosynthesis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]",193.0,0.0786922,"Analysis revealed significantly improved CAPS-5 scores in both groups (effect sizes: DBT-PTSD: d, 1.35; CPT: d, 0.98) and a small but statistically significant superiority of DBT-PTSD (group difference: 4.82 [95% CI, 0.67-8.96]; P = .02; d, 0.33).","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bohus', 'Affiliation': 'Institute of Psychiatric and Psychosomatic Psychotherapy, Central Institute of Mental Health Mannheim, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Kleindienst', 'Affiliation': 'Institute of Psychiatric and Psychosomatic Psychotherapy, Central Institute of Mental Health Mannheim, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hahn', 'Affiliation': 'Institute of Psychiatric and Psychosomatic Psychotherapy, Central Institute of Mental Health Mannheim, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Meike', 'Initials': 'M', 'LastName': 'Müller-Engelmann', 'Affiliation': 'Institute of Psychology, Goethe University Frankfurt am Main, Frankfurt, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Ludäscher', 'Affiliation': 'Institute of Psychiatric and Psychosomatic Psychotherapy, Central Institute of Mental Health Mannheim, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Steil', 'Affiliation': 'Institute of Psychology, Goethe University Frankfurt am Main, Frankfurt, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fydrich', 'Affiliation': 'Department of Psychology, Faculty of Life Sciences, Humboldt University, Berlin, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Kuehner', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Central Institute of Mental Health Mannheim, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Resick', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Stiglmayr', 'Affiliation': 'AWP Berlin, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schmahl', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health Mannheim, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Kathlen', 'Initials': 'K', 'LastName': 'Priebe', 'Affiliation': 'Institute of Psychiatric and Psychosomatic Psychotherapy, Central Institute of Mental Health Mannheim, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.2148']
1528,32694328,The Impact of Unguided Trauma Simulation Practice on Novice Performance: A Randomized Controlled Trial.,"INTRODUCTION


The purpose of this investigation was to determine the impact of simulator practice on task completion time, radiation use, success rate, and overall quality in a simulation of placing a distal locking screw.
METHODS


This was a prospective, randomized control trial with one-to-one randomization and parallel group design. Twenty-eight volunteer novice trainees (medical and premedical students) participated. Using the TraumaVision Virtual Reality Simulator (Swemac, Sweden), subjects performed locking screw placement using the ""perfect circle"" technique. All subjects underwent a pretest and posttest on the simulator. The simulator group completed three additional simulator training sessions. The primary outcome variables were simulator-collected task completion time, success rate, radiation exposure time, and overall score.
RESULTS


No notable difference existed between groups for pretest completion time, radiation use, success rate, or overall score. No notable difference in posttest radiation use or overall procedure score was found between groups. A significant difference existed in posttest total completion time (trained = 251.2 ± 103.4; control = 497.3 ± 223.1; P = 0.001) and success rate (64.3% versus 100%; P = 0.041) between groups. In addition, a significant difference existed in variance between groups for completion time (P = 0.029).
CONCLUSIONS


These findings suggest that independent simulator practice leads to improved speed and success rates; however, radiation use and overall score do not improve in the same manner. The design of simulator-based curriculum must be tailored to specific educational objectives and ultimately validated in the clinical setting.",2020,"No notable difference existed between groups for pretest completion time, radiation use, success rate, or overall score.","['Twenty-eight volunteer novice trainees (medical and premedical students) participated', 'Novice Performance']","['additional simulator training sessions', 'locking screw placement', 'Unguided Trauma Simulation Practice']","['posttest total completion time', 'posttest radiation use or overall procedure score', 'task completion time, radiation use, success rate, and overall quality', 'simulator-collected task completion time, success rate, radiation exposure time, and overall score', 'pretest completion time, radiation use, success rate, or overall score', 'success rate']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0038498', 'cui_str': 'Premedical Student'}]","[{'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0441273', 'cui_str': 'Locking screw'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}]",28.0,0.168417,"No notable difference existed between groups for pretest completion time, radiation use, success rate, or overall score.","[{'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Wang', 'Affiliation': 'From the Department of Orthopaedic Surgery, Mount Sinai Icahn School of Medicine, New York, NY (Dr. Wang), the Department of Orthopaedic Surgery, University of Wisconsin School of Medicine, Madison, WI (Dr. Bernardoni and Dr. Cotter), the Department of Orthopaedic Surgery, Midwest Orthopaedics, Rush University Medical Center, Chicago, IL (Dr. Levine), and the Department of Orthopaedic Surgery, University of Colorado School of Medicine, Denver, CO (Dr. Frank).'}, {'ForeName': 'Eamon D', 'Initials': 'ED', 'LastName': 'Bernardoni', 'Affiliation': ''}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Cotter', 'Affiliation': ''}, {'ForeName': 'Brett R', 'Initials': 'BR', 'LastName': 'Levine', 'Affiliation': ''}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Frank', 'Affiliation': ''}]",The Journal of the American Academy of Orthopaedic Surgeons,['10.5435/JAAOS-D-19-00225']
1529,32700954,A multiple baseline study of a brief alcohol reduction and family engagement intervention for fathers in Kenya.,"OBJECTIVE


To evaluate a lay provider-delivered, brief intervention to reduce problem drinking and related family consequences among men in Kenya. The 5-session intervention combines behavioral activation (BA) and motivational interviewing (MI). It integrates family-related material explicitly and addresses central cultural factors through gender transformative strategies.
METHOD


A nonconcurrent multiple-baseline design was used. We initiated treatment with 9 men ages 30 to 48 who were fathers and screened positive for problem drinking; the median Alcohol Use Identification Test score was 17 (harmful range). Participants were randomized to staggered start dates. We measured the primary outcome of weekly alcohol consumption 4 weeks before treatment, during treatment, and 4 weeks posttreatment using the Timeline Followback measure. Secondary outcomes were assessed using a pre-post assessment (1-month) of men's depression symptoms, drinking- and family-related problem behavior, involvement with child, time with family, family functioning, relationship quality (child and partner), and harsh treatment of child and partner. Men, partners, and children (ages 8-17) reported on family outcomes.
RESULTS


Eight men completed treatment. Mixed-effects hurdle model analysis showed that alcohol use, both number of days drinking and amount consumed, significantly decreased during and after treatment. Odds of not drinking were 5.1 times higher posttreatment (95% CI [3.3, 7.9]). When men did drink posttreatment, they drank 50% less (95% CI [0.39, 0.65]). Wilcoxon signed-ranks test demonstrated pre-post improvements in depression symptoms and family related outcomes.
CONCLUSION


Results provide preliminary evidence that a BA-MI intervention developed for lay providers may reduce alcohol use and improve family outcomes among men in Kenya. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"When men did drink posttreatment, they drank 50% less (95% CI [0.39, 0.65]).","['Eight men completed treatment', '9 men ages 30 to 48 who were fathers and screened positive for problem drinking; the median Alcohol Use Identification Test score was 17 (harmful range', 'Men, partners, and children (ages 8-17) reported on family outcomes', 'men in Kenya', 'fathers in Kenya']","['alcohol reduction and family engagement intervention', 'BA-MI intervention', '5-session intervention combines behavioral activation (BA) and motivational interviewing (MI']","[""pre-post assessment (1-month) of men's depression symptoms, drinking- and family-related problem behavior, involvement with child, time with family, family functioning, relationship quality (child and partner), and harsh treatment of child and partner"", 'depression symptoms and family related outcomes']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0500725,"When men did drink posttreatment, they drank 50% less (95% CI [0.39, 0.65]).","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Giusto', 'Affiliation': 'Department of Psychology and Neuroscience.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Green', 'Affiliation': 'Duke Global Health Institute.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Simmons', 'Affiliation': 'Department of Biostatistics and Bioinformatics.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ayuku', 'Affiliation': 'Department of Behavioural Sciences.'}, {'ForeName': 'Puja', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Eve S', 'Initials': 'ES', 'LastName': 'Puffer', 'Affiliation': 'Department of Psychology and Neuroscience.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000559']
1530,32704547,Sweet taste does not modulate pain perception in adult humans.,"Background : Sugar is routinely used to comfort neonates undergoing painful procedures, and animal studies have shown that sucrose increases the time to withdrawal from painful stimuli. However, there are no published studies examining the effects of sweet substances on heat pain thresholds and percept in adult humans.  Methods : Healthy adult volunteers (n=27, aged 18-48 years) were recruited to a controlled, double-blind, randomised, cross-over study to characterise the effect of tasting solutions of equivalent sweetness (10% sucrose and 0.016% sucralose) on warm detection and heat pain thresholds and the percept ratings of painfully hot stimuli. The effect of anticipation of a sweet taste on heat pain threshold was also assessed.  Results : Tasting either sucrose or sucralose had no significant effect on the percept of an individually titrated hot stimulus (54.5±4.2 and 54.9±3.2 vs 53.2±3.5 for water, 0-100 visual analogue scale), on the warm detection or heat pain threshold (43.3±0.8, 43.2±0.8 vs 43.0±0.8°C). Anticipation of a sweet substance similarly did not affect heat pain thresholds.  Conclusions : Sucrose and sucralose solutions had no analgesic effect when assessed using heat detection thresholds and percept ratings of painfully hot stimuli despite being perceived as sweeter and more pleasant than water. These findings are in contrast to results reported from previous animal studies in which thermal analgesia from sweet solutions is robust. Given the ubiquitous availability of sugar rich drinks in the modern environment, the lack of observable effect may be due to an insufficient hedonic value of the test solutions when compared to the experience of a laboratory rodent. Alternatively, sweet tastes may have a specific effect on pain tolerance rather than the threshold and acute percept measures assayed in this study.",2020,Conclusions : Sucrose and sucralose solutions had no analgesic effect when assessed using heat detection thresholds and percept ratings of painfully hot stimuli despite being perceived as sweeter and more pleasant than water.,"['Healthy adult volunteers (n=27, aged 18-48 years', 'adult humans']","['Sweet taste', 'sucrose or sucralose', 'tasting solutions of equivalent sweetness (10% sucrose and 0.016% sucralose) on warm detection and heat pain thresholds and the percept ratings of painfully hot stimuli', 'sweet substances']","['warm detection or heat pain threshold', 'percept of an individually titrated hot stimulus', 'pain perception', 'pain tolerance', 'heat pain threshold', 'heat pain thresholds']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0858600', 'cui_str': 'Taste sweet'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0077046', 'cui_str': 'sucralose'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0439861', 'cui_str': 'Substance'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",,0.175084,Conclusions : Sucrose and sucralose solutions had no analgesic effect when assessed using heat detection thresholds and percept ratings of painfully hot stimuli despite being perceived as sweeter and more pleasant than water.,"[{'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Mooney', 'Affiliation': 'School of Physiology, Pharmacology & Neuroscience, Biomedical Sciences Building, University of Bristol, Bristol, BS8 1TD, UK.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Davies', 'Affiliation': 'Nuffield Department of Clinical Neuroscience, University of Oxford, Level 6 West Wing, John Radcliffe Hospital, Oxford, OX3 9DU, UK.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Pickering', 'Affiliation': 'School of Physiology, Pharmacology & Neuroscience, Biomedical Sciences Building, University of Bristol, Bristol, BS8 1TD, UK.'}]",Wellcome open research,['10.12688/wellcomeopenres.15726.2']
1531,32708699,A Randomized Controlled Trial of Thermo-Sensitive Sol-Gel Anti-Adhesion Agent after Gynecologic Surgery.,"Postoperative abdominal adhesions can lead to several adverse consequences such as pelvic pain, bowel obstruction, and infertility. We aimed to explore the anti-adhesion efficacy and safety of a thermo-sensitive sol-gel agent in patients who receive abdominopelvic surgery for benign gynecologic disease. This study was a randomized, controlled, single-blind clinical trial of women undergoing benign gynecologic surgery between January 2017 and December 2017. The patients were randomly assigned to three groups with a 1:1:1 ratio: experimental group (received the thermo-sensitive sol-gel agent), control group (untreated), and comparator group (received 4% icodextrin). Patients were followed for 4 weeks postoperatively, and efficacy was evaluated by performing the visceral slide test to identify adhesion formation. In total, 183 patients were enrolled in the study, and 178 (97.3%) completed the trial. The incidence rate of abdominal adhesion formation was significantly lower in the experimental group than in the control group (7.9% vs. 21.1%,  p  = 0.040); however, it was similar between the experimental and comparator groups (7.9% vs. 13.8%.  p  = 0.299). At 4 weeks, no differences in adhesion-related symptoms were observed between the experimental and control groups. Adverse events were mostly mild and did not differ significantly among the three groups ( p  = 0.375). In conclusion, use of a thermo-sensitive sol-gel agent was safe and effective to prevent abdominal adhesions after benign gynecologic surgeries.",2020,Adverse events were mostly mild and did not differ significantly among the three groups ( p  = 0.375).,"['patients who receive abdominopelvic surgery for benign gynecologic disease', 'after Gynecologic Surgery', '183 patients were enrolled in the study, and 178 (97.3%) completed the trial', 'women undergoing benign gynecologic surgery between January 2017 and December 2017']","['thermo-sensitive sol-gel agent', 'Thermo-Sensitive Sol-Gel Anti-Adhesion Agent', 'thermo-sensitive sol-gel agent), control group (untreated), and comparator group (received 4% icodextrin']","['adhesion-related symptoms', 'abdominal adhesions', 'Adverse events', 'incidence rate of abdominal adhesion formation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0017411', 'cui_str': 'Disorder of female genital organs'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0538727', 'cui_str': 'icodextrin'}]","[{'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0549357', 'cui_str': 'Abdominal adhesions'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",183.0,0.0586886,Adverse events were mostly mild and did not differ significantly among the three groups ( p  = 0.375).,"[{'ForeName': 'Young Im', 'Initials': 'YI', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University Hospital, Seoul 03080, Korea.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul 03080, Korea.'}, {'ForeName': 'Se Ik', 'Initials': 'SI', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul 03080, Korea.'}, {'ForeName': 'Aeran', 'Initials': 'A', 'LastName': 'Seol', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul 03080, Korea.'}, {'ForeName': 'Eun Ji', 'Initials': 'EJ', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul 03080, Korea.'}, {'ForeName': 'Hee Seung', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul 03080, Korea.'}, {'ForeName': 'Yong Sang', 'Initials': 'YS', 'LastName': 'Song', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul 03080, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9072261']
1532,32710219,Correction to: Osseous ingrowth in allogeneic bone blocks applied for vertical bone augmentation: a preclinical randomized controlled study.,"In the article by Möst et al., entitled ""Osseous ingrowth in allogeneic bone blocks applied for vertical bone augmentation: a preclinical randomized controlled study.",2020,"In the article by Möst et al., entitled ""Osseous ingrowth in allogeneic bone blocks applied for vertical bone augmentation: a preclinical randomized controlled study.",['vertical bone augmentation'],[],[],"[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]",[],[],,0.0260633,"In the article by Möst et al., entitled ""Osseous ingrowth in allogeneic bone blocks applied for vertical bone augmentation: a preclinical randomized controlled study.","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Moest', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Erlangen-Nürnberg, Glueckstraße 11, 91054, Erlangen, Germany. tobias.moest@uk-erlangen.de.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Frabschka', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Erlangen-Nürnberg, Glueckstraße 11, 91054, Erlangen, Germany.'}, {'ForeName': 'Marco Rainer', 'Initials': 'MR', 'LastName': 'Kesting', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Erlangen-Nürnberg, Glueckstraße 11, 91054, Erlangen, Germany.'}, {'ForeName': 'Christian Martin', 'Initials': 'CM', 'LastName': 'Schmitt', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Erlangen-Nürnberg, Glueckstraße 11, 91054, Erlangen, Germany.'}, {'ForeName': 'Gesche', 'Initials': 'G', 'LastName': 'Frohwitter', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Erlangen-Nürnberg, Glueckstraße 11, 91054, Erlangen, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Lutz', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Erlangen-Nürnberg, Glueckstraße 11, 91054, Erlangen, Germany.'}, {'ForeName': 'Karl Andreas', 'Initials': 'KA', 'LastName': 'Schlegel', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Erlangen-Nürnberg, Glueckstraße 11, 91054, Erlangen, Germany.'}]",Clinical oral investigations,['10.1007/s00784-020-03466-3']
1533,32707403,"Changes to stance limb peak, cumulative, and regional plantar foot forces among normal walking and three mobility aids in healthy older adults.","BACKGROUND


Mobility aids are commonly prescribed to offload an injured lower extremity. Device selection may impact stance foot loading patterns and foot health in clinical populations at risk of foot ulceration.
RESEARCH QUESTIONS


Two questions motivated this study: How does device selection influence peak plantar and regional (rearfoot, mid foot and forefoot) foot forces on the stance foot? Does device selection influence peak, cumulative, and regional plantar forces within a 200 m walking trial?
METHODS


Twenty-one older adults walked 200 m at self-selected pace in four randomized conditions for this prospective crossover study. Participants used a walker, crutches, wheeled knee walker (WKW), and no assistive device (control condition). Plantar forces were measured using a wireless in-shoe system (Loadsol, Novel Inc., St. Paul, MN). Repeated measures analyses of variance were used to determine differences in peak and cumulative total and regional forces among walking conditions. Paired sample t-tests compared forces during first and last 30 s epochs of each condition to determine device influence over time.
RESULTS


The WKW reduced peak net forces by 0.29 and 0.35 bodyweight (BW) when compared to the walker or control condition with similar trends in all foot regions. Crutch use had similar peak forces as control. There were no differences in the number of steps taken within devices comparing first and last epochs. Crutches had a 0.04 and 0.07 BW increase in peak net and forefoot forces during the last epoch. Walker use had 66.44 BW lower cumulative forefoot forces in the last epoch.
SIGNIFICANCE


Crutches had similar stance foot loading as normal walking while a walker lowered forefoot forces at the expense of increased steps. A WKW may be the best choice to 'protect' tissues in the stance foot from exposure to peak and cumulative forces in the forefoot region.",2020,The WKW reduced peak net forces by 0.29 and 0.35 bodyweight (BW) when compared to the walker or control condition with similar trends in all foot regions.,"['healthy older adults', 'Twenty-one older adults walked 200 m at self-selected pace']",['normal walking and three mobility aids'],"['device selection influence peak, cumulative, and regional plantar forces', 'peak net forces', 'Plantar forces', 'peak net and forefoot forces', 'stance limb peak, cumulative, and regional plantar foot forces', 'peak and cumulative total and regional forces among walking conditions', 'cumulative forefoot forces']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C3495449', 'cui_str': 'Mobility aid'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",21.0,0.0456241,The WKW reduced peak net forces by 0.29 and 0.35 bodyweight (BW) when compared to the walker or control condition with similar trends in all foot regions.,"[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Kingston', 'Affiliation': 'College of Medicine, University of Saskatchewan, 107 Wiggins Rd, Saskatoon, SK, S7N 5E5, Canada. Electronic address: david.kingston@usask.ca.'}, {'ForeName': 'A Gary', 'Initials': 'AG', 'LastName': 'Linassi', 'Affiliation': 'College of Medicine, University of Saskatchewan, 107 Wiggins Rd, Saskatoon, SK, S7N 5E5, Canada; School of Rehabilitation Science, University of Saskatchewan, Suite 3400, 3rd Floor, 104 Clinic Pl, Saskatoon, SK, S7N 2Z4, Canada. Electronic address: anl931@mail.usask.ca.'}, {'ForeName': 'Audrey R', 'Initials': 'AR', 'LastName': 'Zucker-Levin', 'Affiliation': 'School of Rehabilitation Science, University of Saskatchewan, Suite 3400, 3rd Floor, 104 Clinic Pl, Saskatoon, SK, S7N 2Z4, Canada. Electronic address: audrey.zuckerlevin@usask.ca.'}]",Gait & posture,['10.1016/j.gaitpost.2020.07.015']
1534,32708292,The Impact of Novel Anticoagulants on the Upper Gastrointestinal Tract Mucosa.,"Background and objectives:  Although treatment with novel oral non-vitamin K antagonist 3anticoagulants (NOACs) is associated with an overall decrease in hemorrhagic complications compared to warfarin, the incidence of gastrointestinal bleeding remains contradictory.  Materials and Methods:  After the exclusion of patients with pre-existing pathological lesions in the upper gastrointestinal tract (GIT) on esophageal-gastroduodenoscopy (EGD) at entry, a cohort of 80 patients (mean age of 74.8 ± 2.0 years) was randomly divided into four equivalent groups, treated with dabigatran, rivaroxaban, apixaban, or warfarin. Patients were prospectively followed up for three months of treatment, with a focus on anamnestic and endoscopic signs of bleeding. In addition, bleeding risk factors were evaluated.  Results:  In none of the patients treated with warfarin or NOACs was any serious or clinically significant bleeding recorded within the follow-up period. The incidence of clinical bleeding and endoscopically detected bleeding in the upper GT after three months of treatment was not statistically different among groups (χ 2  = 2.8458;  p  = 0.41608). The presence of  Helicobacter pylori  (HP) was a risk factor for upper GIT bleeding ( p  < 0.05), while the use of proton pump inhibitors (PPIs) was a protective factor ( p  = 0.206; Spearman's correlation coefficient = 0.205). We did not record any post-biopsy continued bleeding.  Conclusions:  No significant GIT bleeding was found in any of the treatment groups, so we consider it beneficial to perform routine EGD before the initiation of any anticoagulant therapy in patients with an increased risk of upper GIT bleeding. Detection and eradication of HP as well as preventive PPI treatment may mitigate the occurrence of endoscopic bleeding. Endoscopic biopsy during the NOAC treatment is safe.",2020,"The presence of  Helicobacter pylori  (HP) was a risk factor for upper GIT bleeding ( p  < 0.05), while the use of proton pump inhibitors (PPIs) was a protective factor ( p  = 0.206; Spearman's correlation coefficient = 0.205).","['patients with pre-existing pathological lesions in the upper gastrointestinal tract (GIT) on esophageal-gastroduodenoscopy (EGD) at entry, a cohort of 80 patients (mean age of 74.8 ± 2.0 years']","['novel oral non-vitamin K antagonist 3anticoagulants (NOACs', 'dabigatran, rivaroxaban, apixaban, or warfarin', 'warfarin or NOACs', 'Novel Anticoagulants', 'Endoscopic biopsy']","['bleeding risk factors', 'GIT bleeding', 'hemorrhagic complications', 'presence of  Helicobacter pylori  (HP', 'risk of upper GIT bleeding', 'anamnestic and endoscopic signs of bleeding', 'incidence of clinical bleeding and endoscopically detected bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0192657', 'cui_str': 'Gastroduodenoscopy'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0642228', 'cui_str': 'N(4)-oleylcytosine arabinoside'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0184980', 'cui_str': 'Endoscopic biopsy'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0442726', 'cui_str': 'Detected'}]",80.0,0.0200152,"The presence of  Helicobacter pylori  (HP) was a risk factor for upper GIT bleeding ( p  < 0.05), while the use of proton pump inhibitors (PPIs) was a protective factor ( p  = 0.206; Spearman's correlation coefficient = 0.205).","[{'ForeName': 'Lubomir', 'Initials': 'L', 'LastName': 'Mihalkanin', 'Affiliation': 'Gastroenterology Department, Gastro-LM, 080 01 Presov, Slovakia.'}, {'ForeName': 'Branislav', 'Initials': 'B', 'LastName': 'Stancak', 'Affiliation': 'Cardiology Department, East Slovakia Institute for Cardiovascular Diseases, 040 11 Kosice, Slovakia.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56070363']
1535,32715381,Investigation of Safety and Tolerability of ASP3652 Based on Clinical Studies of Cerebrospinal Fluid Transfer After Multiple Doses and Exposure After Single Doses at High Dose Levels.,"INTRODUCTION


The studies described here were conducted to investigate the central nervous system (CNS) transfer of ASP3652, a peripherally acting inhibitor of fatty acid amide hydrolase, after multiple doses at around the anticipated therapeutic dose and the safety, tolerability, and pharmacokinetics after single doses at corresponding supratherapeutic doses in healthy subjects.
METHODS


Study 1 was an open-label multiple dose study in which ASP3652 (300 mg bid) or matching placebo was administered in multiple doses to healthy subjects. Study 2 was a placebo-controlled, randomized 4 × 4 crossover study in which ASP3652 was given as three single ascending doses of ASP3652 (600-1800 mg) or matching placebo to healthy subjects. Levels of ASP3652 and endocannabinoids (eCBs) in plasma, cerebrospinal fluid (CSF) (study 1 only), and safety were evaluated.
RESULTS


In study 1, ASP3652 was readily absorbed to reach C max  at 1 h after dosing. AUC tau  and C max  of ASP3652 in CSF were approximately 0.2% and 0.06% of the AUC tau  and C max  in plasma after multiple doses of ASP3652 300 mg bid. At steady state the area under the response-time curve (AURC) from 0 to 12 h and the maximum response for anandamide in plasma were approximately 550-fold and 230-fold higher than those in CSF. In study 2, the C max  and AUC of ASP3652 increased higher than dose proportionally in subjects receiving 600-1800 mg ASP3652. For eCBs, although the AURC increased less than dose proportionally, maximum plasma levels were comparable across all treatment groups. The incidence of adverse events (AEs) was similar across all treatment groups including the placebo group. There was no evidence of CNS-related side effects.
CONCLUSIONS


ASP3652 showed low CNS penetration at the anticipated therapeutic dose and was well tolerable without any CNS-related AEs at supratherapeutic doses, supporting that the drug can be safely tested at the anticipated therapeutic dose.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT02034734 for study 1, NCT01815684 for study 2.",2020,"Levels of ASP3652 and endocannabinoids (eCBs) in plasma, cerebrospinal fluid (CSF)","['to healthy subjects', 'healthy subjects']","['placebo', 'ASP3652', 'matching placebo', 'ASP3652 (300\xa0mg bid) or matching placebo']","['response-time curve (AURC', 'AUC tau  and C max  of ASP3652 in CSF', 'maximum plasma levels', 'low CNS penetration', 'Cerebrospinal Fluid Transfer', 'C max  and AUC of ASP3652', 'incidence of adverse events (AEs', 'maximum response for anandamide in plasma', 'Levels of ASP3652 and endocannabinoids (eCBs) in plasma, cerebrospinal fluid (CSF']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0211726', 'cui_str': 'anandamide'}, {'cui': 'C1172779', 'cui_str': 'Endocannabinoid'}]",,0.105325,"Levels of ASP3652 and endocannabinoids (eCBs) in plasma, cerebrospinal fluid (CSF)","[{'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Takizawa', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan. masaomi.takizawa@astellas.com.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Cerneus', 'Affiliation': 'Astellas Pharma Europe B. V., Leiden, The Netherlands.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Michon', 'Affiliation': 'Astellas Pharma Europe B. V., Leiden, The Netherlands.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Rijnders', 'Affiliation': 'Astellas Pharma Europe B. V., Leiden, The Netherlands.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Meijer', 'Affiliation': 'Astellas Pharma Europe B. V., Leiden, The Netherlands.'}, {'ForeName': 'Akiyoshi', 'Initials': 'A', 'LastName': 'Someya', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Astellas Pharma Inc, Ibaraki, Japan.'}]",Advances in therapy,['10.1007/s12325-020-01451-6']
1536,32712560,Long-term evaluation of open-label pimavanserin safety and tolerability in Parkinson's disease psychosis.,"INTRODUCTION


Pimavanserin is a selective 5-HT 2A  inverse agonist/antagonist approved for treating hallucinations and delusions associated with Parkinson's disease psychosis (PDP). Results from short-term, placebo-controlled studies demonstrated a positive benefit/risk profile. This multi-year, open-label study assessed long-term safety and tolerability of pimavanserin.
METHODS


This was an open-label extension (OLE) study in patients previously completing a double-blind, placebo-controlled study or a previous OLE study. Safety was evaluated from adverse events (AEs), clinical laboratory results, motor symptoms, electrocardiograms (ECG), and mortality. Durability of response was assessed from the Clinical Global Impression-Severity (CGI-S) scale and Caregiver Burden Scale (CBS).
RESULTS


Of 459 participants treated in this OLE study (average age 71.2 years), the median duration of treatment was 454 days. Over the entire study period (approximately 11 years), ≥1 AE occurred in 392 (85.4%) patients; the majority were of mild to moderate intensity, with fall (32.0%), urinary tract infection (19.0%), and hallucination (13.7%) most common. Serious AEs occurred in 188 (41.0%) patients, and an AE leading to study termination or dose discontinuation occurred in 133 (29.0%) patients. Sixty-one patients died, 59 (12.9%) during treatment or within 30 days after the last dose of study drug; the observed mortality rate was 6.45 per 100 patient-years of exposure. Mean scores for the CGI-S scale and CBS generally remained stable for up to 192 weeks (>3.5 years).
CONCLUSIONS


Long-term treatment with pimavanserin 34 mg once daily demonstrated a favorable benefit/risk profile with no unexpected safety concerns. Mortality rates suggested no increased risk following long-term treatment.",2020,"Mean scores for the CGI-S scale and CBS generally remained stable for up to 192 weeks (>3.5 years).
","[""Parkinson's disease psychosis"", '459 participants treated in this OLE study (average age 71.2 years']","['pimavanserin', 'Pimavanserin', 'placebo']","['adverse events (AEs), clinical laboratory results, motor symptoms, electrocardiograms (ECG), and mortality', 'Mean scores for the CGI-S scale and CBS', 'Clinical Global Impression-Severity (CGI-S) scale and Caregiver Burden Scale (CBS', 'urinary tract infection', 'AE leading to study termination or dose discontinuation', 'Serious AEs', 'Mortality rates', 'observed mortality rate', 'median duration of treatment']","[{'cui': 'C3805119', 'cui_str': ""Parkinson's disease psychosis""}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1722267', 'cui_str': 'pimavanserin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}]",459.0,0.12366,"Mean scores for the CGI-S scale and CBS generally remained stable for up to 192 weeks (>3.5 years).
","[{'ForeName': 'Clive G', 'Initials': 'CG', 'LastName': 'Ballard', 'Affiliation': 'University of Exeter Medical School, Exeter, UK. Electronic address: c.ballard@exeter.ac.uk.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Kreitzman', 'Affiliation': ""Parkinson's Disease and Movement Disorders Center of Long Island, Commack, NY, USA.""}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Isaacson', 'Affiliation': ""Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, FL, USA.""}, {'ForeName': 'I-Yuan', 'Initials': 'IY', 'LastName': 'Liu', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, CA, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Norton', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, CA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Demos', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, CA, USA.'}, {'ForeName': 'Hubert H', 'Initials': 'HH', 'LastName': 'Fernandez', 'Affiliation': 'Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Tihomir V', 'Initials': 'TV', 'LastName': 'Ilic', 'Affiliation': 'Medical Faculty of Military Medical Academy, Belgrade, Serbia.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Azulay', 'Affiliation': 'Timone Hospital, Marseille, France.'}, {'ForeName': 'Joaquim J', 'Initials': 'JJ', 'LastName': 'Ferreira', 'Affiliation': 'Faculty of Medicine, University of Lisbon, Lisbon, Portugal.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Abler', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, CA, USA.'}, {'ForeName': 'Srdjan', 'Initials': 'S', 'LastName': 'Stankovic', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.06.026']
1537,32712569,"A randomized pilot trial of topiramate for alcohol use disorder in veterans with traumatic brain injury: Effects on alcohol use, cognition, and post-concussive symptoms.","BACKGROUND


Topiramate is an effective treatment for alcohol use disorder (AUD) and has also been used in the care of mild traumatic brain injury (mTBI). This pilot study aimed to obtain a preliminary assessment of topiramate's efficacy in reducing alcohol use and post-concussive symptoms, and its potential negative impact on cognitive function in 32 Veterans with co-occurring AUD and mTBI.
METHODS


This was a prospective 12-week, randomized, double-blind, placebo-controlled pilot study of flexible-dose topiramate or placebo. Primary outcome was reduction of drinking days per week within the topiramate arm. Secondary outcomes included between group comparisons of alcohol use and craving, post-concussive symptoms, and cognitive function.
RESULTS


Drinking days per week significantly decreased within both the topiramate and placebo arm. There were no significant treatment-by-week interactions on alcohol use/craving, or post-concussive symptoms in intent-to-treat analyses. In per-protocol analyses, topiramate significantly reduced number of drinks per week compared with placebo. Topiramate transiently impaired verbal fluency and working memory. Processing speed, cognitive inhibition, and mental flexibility significantly improved between weeks 1 and 12, regardless of treatment arm.
CONCLUSIONS


Significant improvement occurred in both the topiramate and placebo groups over 12 weeks of treatment in alcohol use and post-concussive symptoms. Among treatment completers there was greater reduction of alcohol use in the topiramate arm. Topiramate was also associated with negative but transient effects on cognitive function. Results suggest both a possible benefit for topiramate treatment in reducing alcohol use and some potential for negative cognitive effects in Veterans with AUD and mTBI.",2020,"Processing speed, cognitive inhibition, and mental flexibility significantly improved between weeks 1 and 12, regardless of treatment arm.
","['32 Veterans with co-occurring AUD and mTBI', 'Veterans with AUD and mTBI', 'veterans with traumatic brain injury']","['Topiramate', 'flexible-dose topiramate or placebo', 'placebo', 'topiramate']","['reduction of alcohol use', 'alcohol use/craving, or post-concussive symptoms', 'alcohol use and craving, post-concussive symptoms, and cognitive function', 'verbal fluency and working memory', 'cognitive function', 'reduction of drinking days', 'Processing speed, cognitive inhibition, and mental flexibility']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}]","[{'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0546983', 'cui_str': 'Postconcussion syndrome'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",32.0,0.0870034,"Processing speed, cognitive inhibition, and mental flexibility significantly improved between weeks 1 and 12, regardless of treatment arm.
","[{'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Pennington', 'Affiliation': 'University of California, San Francisco, Department of Psychiatry, 4150 Clement St., San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System (SFVAHCS), 4150 Clement St., San Francisco, CA, USA; Northern California Institute for Research and Education (NCIRE), 4150 Clement St., San Francisco, CA, USA. Electronic address: david.pennington2@va.gov.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Bielenberg', 'Affiliation': 'San Francisco Veterans Affairs Health Care System (SFVAHCS), 4150 Clement St., San Francisco, CA, USA; Northern California Institute for Research and Education (NCIRE), 4150 Clement St., San Francisco, CA, USA.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Lasher', 'Affiliation': 'San Francisco Veterans Affairs Health Care System (SFVAHCS), 4150 Clement St., San Francisco, CA, USA; Northern California Institute for Research and Education (NCIRE), 4150 Clement St., San Francisco, CA, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Herbst', 'Affiliation': 'University of California, San Francisco, Department of Psychiatry, 4150 Clement St., San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System (SFVAHCS), 4150 Clement St., San Francisco, CA, USA; Northern California Institute for Research and Education (NCIRE), 4150 Clement St., San Francisco, CA, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Abrams', 'Affiliation': 'San Francisco Veterans Affairs Health Care System (SFVAHCS), 4150 Clement St., San Francisco, CA, USA.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Novakovic-Agopian', 'Affiliation': 'University of California, San Francisco, Department of Psychiatry, 4150 Clement St., San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System (SFVAHCS), 4150 Clement St., San Francisco, CA, USA; Northern California Institute for Research and Education (NCIRE), 4150 Clement St., San Francisco, CA, USA.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Batki', 'Affiliation': 'University of California, San Francisco, Department of Psychiatry, 4150 Clement St., San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System (SFVAHCS), 4150 Clement St., San Francisco, CA, USA; Northern California Institute for Research and Education (NCIRE), 4150 Clement St., San Francisco, CA, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108149']
1538,32718193,Detecting asthma exacerbations using daily home monitoring and machine learning.,"OBJECTIVE


Acute exacerbations contribute significantly to the morbidity of asthma. Recent studies have shown that early detection and treatment of asthma exacerbations leads to improved outcomes. We aimed to develop a machine learning algorithm to detect severe asthma exacerbations using easily available daily monitoring data.
METHODS


We analyzed daily peak expiratory flow and symptom scores recorded by participants in the SAKURA study (NCT00839800), an international multicentre randomized controlled trial comparing budesonide/formoterol as maintenance and reliever therapy versus budesonide/formoterol maintenance plus terbutaline as reliever, in adults with persistent asthma. The dataset consisted of 728,535 records of daily monitoring data in 2010 patients, with 576 severe exacerbation events. Data post-processing techniques included normalization, standardization, calculation of differences or slopes over time and the use of smoothing filters. Principal components analysis was used to reduce the large number of derived variables to a smaller number of linearly independent components. Logistic regression, decision tree, naïve Bayes, and perceptron algorithms were evaluated. Model accuracy was assessed using stratified cross-validation. The primary outcome was the detection of exacerbations on the same day or up to three days in the future.
RESULTS


The best model used logistic regression with input variables derived from post-processed data using principal components analysis. This had an area under the receiver operating characteristic curve of 0.85, with a sensitivity of 90% and specificity of 83% for severe asthma exacerbations.
CONCLUSION


Asthma exacerbations may be detected using machine learning algorithms applied to daily self-monitoring of peak expiratory flow and asthma symptoms.",2020,"This had an area under the receiver operating characteristic curve of 0.85, with a sensitivity of 90% and specificity of 83% for severe asthma exacerbations.","['adults with persistent asthma', '2010 patients, with 576 severe exacerbation events']","['budesonide/formoterol maintenance plus terbutaline', 'daily home monitoring and machine learning', 'budesonide/formoterol', 'machine learning algorithm']","['daily peak expiratory flow and symptom scores', 'detection of exacerbations', 'morbidity of asthma', 'peak expiratory flow and asthma symptoms', 'Model accuracy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}]","[{'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039542', 'cui_str': 'Terbutaline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",,0.440755,"This had an area under the receiver operating characteristic curve of 0.85, with a sensitivity of 90% and specificity of 83% for severe asthma exacerbations.","[{'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Zhang', 'Affiliation': 'Department of Computer Engineering (INFO), INSA Rennes, Rennes, France.'}, {'ForeName': 'Leandro L', 'Initials': 'LL', 'LastName': 'Minku', 'Affiliation': 'School of Computer Science, University of Birmingham, UK.'}, {'ForeName': 'Sherif', 'Initials': 'S', 'LastName': 'Gonem', 'Affiliation': 'Department of Respiratory Medicine, Nottingham City Hospital, Nottingham, UK.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2020.1802746']
1539,32718927,Are prolonged sitting and sleep restriction a dual curse for the modern workforce? a randomised controlled trial protocol.,"INTRODUCTION


Prolonged sitting and inadequate sleep are a growing concern in society and are associated with impairments to cardiometabolic health and cognitive performance. However, the combined effect of prolonged sitting and inadequate sleep on measures of health and cognitive performance are unknown. In addition, the circadian disruption caused by shiftwork may further impact workers' cardiometabolic health and cognitive performance. This protocol paper outlines the methodology for exploring the impact of simultaneous exposure to prolonged sitting, sleep restriction and circadian disruption on cardiometabolic and cognitive performance outcomes.
METHODS AND ANALYSIS


This between-subjects study will recruit 208 males and females to complete a 7-day in-laboratory experimental protocol (1 Adaptation Day, 5 Experimental Days and 1 Recovery Day). Participants will be allocated to one of eight conditions that include all possible combinations of the following: dayshift or nightshift, sitting or breaking up sitting and 5 hour or 9 hour sleep opportunity. On arrival to the laboratory, participants will be provided with a 9 hour baseline sleep opportunity (22:00 to 07:00) and complete five simulated work shifts (09:00 to 17:30 in the dayshift condition and 22:00 to 06:30 in the nightshift condition) followed by a 9 hour recovery sleep opportunity (22:00 to 07:00). During the work shifts participants in the sitting condition will remain seated, while participants in the breaking up sitting condition will complete 3-min bouts of light-intensity walking every 30 mins on a motorised treadmill. Sleep opportunities will be 9 hour or 5 hour. Primary outcome measures include continuously measured interstitial blood glucose, heart rate and blood pressure, and a cognitive performance and self-perceived capacity testing battery completed five times per shift. Analyses will be conducted using linear mixed models.
ETHICS AND DISSEMINATION


The CQUniversity Human Ethics Committee has approved this study (0000021914). All participants who have already completed the protocol have provided informed consent. Study findings will be disseminated via scientific publications and conference presentations.
TRIAL REGISTRATION DETAILS


This study has been registered on Australian New Zealand Clinical Trials Registry (12619001516178) and is currently in the pre-results stage.",2020,"Participants will be allocated to one of eight conditions that include all possible combinations of the following: dayshift or nightshift, sitting or breaking up sitting and 5 hour or 9 hour sleep opportunity.","['208 males and females to complete a 7-day in-laboratory experimental protocol (1 Adaptation Day, 5 Experimental Days and 1 Recovery Day', 'All participants who have already completed the protocol have provided informed consent']","['dayshift or nightshift, sitting or breaking up sitting and 5\u2009hour or 9\u2009hour sleep opportunity']","['continuously measured interstitial blood glucose, heart rate and blood pressure, and a cognitive performance and self-perceived capacity testing battery completed five times per shift']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C1442467', 'cui_str': '5 hours'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1522203', 'cui_str': 'Interstitial route'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0333051', 'cui_str': 'Shift'}]",208.0,0.0567258,"Participants will be allocated to one of eight conditions that include all possible combinations of the following: dayshift or nightshift, sitting or breaking up sitting and 5 hour or 9 hour sleep opportunity.","[{'ForeName': 'Grace E', 'Initials': 'GE', 'LastName': 'Vincent', 'Affiliation': 'Appleton Institute, Central Queensland University - Adelaide Campus, Wayville, South Australia, Australia g.vincent@cqu.edu.au.'}, {'ForeName': 'Charlotte C', 'Initials': 'CC', 'LastName': 'Gupta', 'Affiliation': 'Appleton Institute, Central Queensland University - Adelaide Campus, Wayville, South Australia, Australia.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Sprajcer', 'Affiliation': 'Appleton Institute, Central Queensland University - Adelaide Campus, Wayville, South Australia, Australia.'}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Vandelanotte', 'Affiliation': 'School of Health Medical and Applied Sciences, Central Queensland University, Rockhampton, Queensland, Australia.'}, {'ForeName': 'Mitch J', 'Initials': 'MJ', 'LastName': 'Duncan', 'Affiliation': 'School of Medicine & Public Health, Faculty of Health and Medicine, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Tucker', 'Affiliation': 'Psychology Department, Swansea University, Swansea, United Kingdom.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Lastella', 'Affiliation': 'Appleton Institute, Central Queensland University - Adelaide Campus, Wayville, South Australia, Australia.'}, {'ForeName': 'Georgia A', 'Initials': 'GA', 'LastName': 'Tuckwell', 'Affiliation': 'Appleton Institute, Central Queensland University - Adelaide Campus, Wayville, South Australia, Australia.'}, {'ForeName': 'Sally A', 'Initials': 'SA', 'LastName': 'Ferguson', 'Affiliation': 'Appleton Institute, Central Queensland University - Adelaide Campus, Wayville, South Australia, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-040613']
1540,32718934,Use of a diabetes-specific nutritional shake to replace a daily breakfast and afternoon snack improves glycemic responses assessed by continuous glucose monitoring in people with type 2 diabetes: a randomized clinical pilot study.,"INTRODUCTION


This pilot study evaluated the impact of a diabetes-specific nutritional shake (DSNS) used twice daily by people with type 2 diabetes (T2D) on glycemic response assessed by continuous glucose monitoring (CGM).
RESEARCH DESIGN AND METHODS


Adults (n=81) with T2D managed by oral medications were studied in a randomized, open-label, three-group parallel study design. The study was conducted in two phases over 14 days: Baseline (days 1-6), during which study participants consumed their habitual self-selected diets (SSD), followed by the Intervention (days 7-14), during which participants were randomized as follows: (1) SSD group received no study product (n=32); (2) DSNS breakfast/afternoon snack (Bkfst/AS) group consumed one DSNS as a breakfast meal replacement and a second to replace their mid-afternoon snack (n=24); (3) DSNS breakfast/prebed snack (Bkfst/PBS) group consumed one DSNS as a breakfast meal replacement and added a second as a prebed snack (n=25). Glucose was assessed by CGM throughout the study. Additionally, participants were asked about snacking behaviors, cravings, and other questions related to the use of DSNS as meal replacements and snacks.
RESULTS


All groups reduced their postprandial glycemic response (positive area under the curve (pAUC, mg/min*dL -1 )) and adjusted peak value (mg/dL) when compared with the baseline phase. Participants consuming DSNS in place of their usual breakfast showed greater reductions in pAUC compared with the SSD group (p=0.008) for the DSNS Bkfst/AS group with a trend (p=0.069) for the DSNS Bkfst/PBS group. Adjusted peak value showed greater reductions in both DSNS groups as compared with the SSD group (p=0.002 for DSNS Bkfst/AS and p=0.010 for DSNS Bkfst/PBS). Nocturnal glucose variability was significantly decreased during the intervention phase compared with baseline phase in the DSNS Bkfst/AS group (p=0.020), with no significant differences between groups. After intervention, the DSNS Bkfst/AS group had a significantly lower percentage of participants (17%) reporting cravings for starchy meals/sides compared with before the study (33%) (p=0.046). This group also reported a significant increase in confidence in choosing foods to control their diabetes (from 58.3% to 91.7%, preintervention vs postintervention, respectively, p=0.005).
CONCLUSIONS


Use of DSNS to replace breakfast and as an afternoon snack improves both glycemic control and behavioral factors related to dietary management of diabetes.
TRAIL REGISTRATION NUMBER


NCT04230889.",2020,AS group had a significantly lower percentage of participants (17%) reporting cravings for starchy meals/sides compared with before the study (33%) (p=0.046).,"['people with type 2 diabetes (T2D', 'Adults (n=81) with T2D managed by oral medications', 'people with type 2 diabetes']","['continuous glucose monitoring (CGM', 'habitual self-selected diets (SSD', 'diabetes-specific nutritional shake to replace a daily breakfast and afternoon snack', 'diabetes-specific nutritional shake (DSNS', 'DSNS breakfast/afternoon snack (Bkfst/AS) group consumed one DSNS as a breakfast meal replacement and a second to replace their mid-afternoon snack (n=24); (3) DSNS breakfast/prebed snack (Bkfst/PBS) group consumed one DSNS as a breakfast meal replacement and added a second as a prebed snack', 'SSD']","['Glucose', 'pAUC', 'Nocturnal glucose variability', 'glycemic responses', 'postprandial glycemic response (positive area under the curve (pAUC, mg/min*dL -1 )) and adjusted peak value', 'reporting cravings for starchy meals/sides', 'confidence in choosing foods to control their diabetes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0441987', 'cui_str': 'Side'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",81.0,0.0241566,AS group had a significantly lower percentage of participants (17%) reporting cravings for starchy meals/sides compared with before the study (33%) (p=0.046).,"[{'ForeName': 'Vikkie A', 'Initials': 'VA', 'LastName': 'Mustad', 'Affiliation': 'Research and Development Department, Abbott Nutrition, Columbus, Ohio, USA.'}, {'ForeName': 'Refaat A', 'Initials': 'RA', 'LastName': 'Hegazi', 'Affiliation': 'Research and Development Department, Abbott Nutrition, Columbus, Ohio, USA Refaat.Hegazi@abbott.com.'}, {'ForeName': 'Deborah S', 'Initials': 'DS', 'LastName': 'Hustead', 'Affiliation': 'Research and Development Department, Abbott Nutrition, Columbus, Ohio, USA.'}, {'ForeName': 'Erwin S', 'Initials': 'ES', 'LastName': 'Budiman', 'Affiliation': 'Research and Development Department, Abbott Diabetes Care, Alameda, California, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Rueda', 'Affiliation': 'Research and Development Department, Abbott Nutrition, Granada, Spain.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Maki', 'Affiliation': 'President and Chief Scientist, MB Clinical Research, Boca Raton, Florida, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Powers', 'Affiliation': 'International Diabetes Center at Park Nicollet, St. Louis Park, Minnesota, USA.'}, {'ForeName': 'Jeffrey I', 'Initials': 'JI', 'LastName': 'Mechanick', 'Affiliation': 'Professor of Medicine and Medical Director, Kravis Center for Cardiovascular Health at Mount Sinai Heart, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Bergenstal', 'Affiliation': 'International Diabetes Center at Park Nicollet, St. Louis Park, Minnesota, USA.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Hamdy', 'Affiliation': 'Obesity Clinical Program, Director of Inpatient Diabetes Program, Joslin Diabetes Center, Boston, Massachusetts, USA.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2020-001258']
1541,32719487,Assessment of cognitive and neural recovery in survivors of pediatric brain tumors in a pilot clinical trial using metformin.,"We asked whether pharmacological stimulation of endogenous neural precursor cells (NPCs) may promote cognitive recovery and brain repair, focusing on the drug metformin, in parallel rodent and human studies of radiation injury. In the rodent cranial radiation model, we found that metformin enhanced the recovery of NPCs in the dentate gyrus, with sex-dependent effects on neurogenesis and cognition. A pilot double-blind, placebo-controlled crossover trial was conducted (ClinicalTrials.gov, NCT02040376) in survivors of pediatric brain tumors who had been treated with cranial radiation. Safety, feasibility, cognitive tests and MRI measures of white matter and the hippocampus were evaluated as endpoints. Twenty-four participants consented and were randomly assigned to complete 12-week cycles of metformin (A) and placebo (B) in either an AB or BA sequence with a 10-week washout period at crossover. Blood draws were conducted to monitor safety. Feasibility was assessed as recruitment rate, medication adherence and procedural adherence. Linear mixed modeling was used to examine cognitive and MRI outcomes as a function of cycle, sequence and treatment. We found no clinically relevant safety concerns and no serious adverse events associated with metformin. Sequence effects were observed for all cognitive outcomes in our linear mixed models. For the subset of participants with complete data in cycle 1, metformin was associated with better performance than placebo on tests of declarative and working memory. We present evidence that a clinical trial examining the effects of metformin on cognition and brain structure is feasible in long-term survivors of pediatric brain tumors and that metformin is safe to use and tolerable in this population. This pilot trial was not intended to test the efficacy of metformin for cognitive recovery and brain growth, but the preliminary results are encouraging and warrant further investigation in a large multicenter phase 3 trial.",2020,"For the subset of participants with complete data in cycle 1, metformin was associated with better performance than placebo on tests of declarative and working memory.","['Twenty-four participants consented', 'survivors of pediatric brain tumors', 'survivors of pediatric brain tumors who had been treated with cranial radiation']","['metformin (A) and placebo (B', 'pharmacological stimulation of endogenous neural precursor cells (NPCs', 'metformin', 'placebo']","['Safety, feasibility, cognitive tests and MRI measures of white matter and the hippocampus', 'declarative and working memory', 'recruitment rate, medication adherence and procedural adherence', 'recovery of NPCs']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0441694', 'cui_str': 'Pharmacological stimulation'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}]",24.0,0.0743775,"For the subset of participants with complete data in cycle 1, metformin was associated with better performance than placebo on tests of declarative and working memory.","[{'ForeName': 'Ramy', 'Initials': 'R', 'LastName': 'Ayoub', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Ruddy', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cox', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Adeoye', 'Initials': 'A', 'LastName': 'Oyefiade', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Derkach', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Laughlin', 'Affiliation': 'Diagnostic Imaging, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ades-Aron', 'Affiliation': 'Center for Biomedical Imaging, Department of Radiology, New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Shirzadi', 'Affiliation': 'Department of Medical Biophysics, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Els', 'Initials': 'E', 'LastName': 'Fieremans', 'Affiliation': 'Center for Biomedical Imaging, Department of Radiology, New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'MacIntosh', 'Affiliation': 'Department of Medical Biophysics, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Cynthia B', 'Initials': 'CB', 'LastName': 'de Medeiros', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Jovanka', 'Initials': 'J', 'LastName': 'Skocic', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bouffet', 'Affiliation': 'Division of Haematology/Oncology, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Freda D', 'Initials': 'FD', 'LastName': 'Miller', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Cindi M', 'Initials': 'CM', 'LastName': 'Morshead', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada. cindi.morshead@utoronto.ca.'}, {'ForeName': 'Donald J', 'Initials': 'DJ', 'LastName': 'Mabbott', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada. donald.mabbott@sickkids.ca.'}]",Nature medicine,['10.1038/s41591-020-0985-2']
1542,32692216,"Treatment of hyperlipidemic acute pancreatitis with modified Dachengqi decoction combining with conventional therapy based on ""six-hollow-organs to be unblocked"" theory.","BACKGROUND


The increase of triglyceride (TG) can induce coronary heart disease, atherosclerosis, pancreatitis and other diseases and is the most common inducing factor of acute pancreatitis (AP) second only to biliary tract disease and drinking. The pathogenesis of hyperlipidemic acute pancreatitis (HLAP) is not exactly clear, but it may be related to the toxic effect of the increase of free fatty acids produced by TG decomposition on the pancreas itself, microcirculation disorder of the pancreas, and calcium overload. At present, non-surgical therapy is the main treatment for HLAP. The key to preventing recurrence is to reduce blood lipids, change the diet structure, and reduce weight. This study aimed to treat HLAP with modified Dachengqi decoction combined with conventional therapy, based on the ""six-hollow-organs to be unblocked"" theory.
METHODS


Forty patients with HLAP who received treatment in the First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine and Puding County Hospital of Traditional Chinese Medicine from September 2016 to August 2019 were selected and divided into a control group and an intervention group, each with 20 cases, following a random number table. The control group was treated with conventional therapy while the intervention group was treated with modified Dachengqi decoction combined with conventional therapy.
RESULTS


After treatment, the cure rate and the total effective rate were 60% and 95% respectively in the intervention group, and 25% and 75% respectively in the control group (P<0.05). The TG, serum amylase, leukocyte count, and neutrophil ratio of the two groups decreased significantly after treatment, and there was a greater decrease in the intervention group than that in the control group, with this being significantly different between the two groups. The gastrointestinal function score, total score of the acute physiology and chronic health evaluation II (APACHE II), and the pain score of the visual analog scale (VAS) decreased markedly in the two groups after the treatment, with scores in the intervention group being significantly lower than those in the control group (P<0.05).
CONCLUSIONS


Modified Dachengqi decoction combined with conventional therapy has a better therapeutic effect on HLAP than conventional therapy.",2020,"After treatment, the cure rate and the total effective rate were 60% and 95% respectively in the intervention group, and 25% and 75% respectively in the control group (P<0.05).","['hyperlipidemic acute pancreatitis', 'hyperlipidemic acute pancreatitis (HLAP', 'Forty patients with HLAP who received treatment in the First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine and Puding County Hospital of Traditional Chinese Medicine from September 2016 to August 2019']","['HLAP with modified Dachengqi decoction combined with conventional therapy', 'modified Dachengqi decoction combining with conventional therapy', 'triglyceride (TG', 'conventional therapy', 'Modified Dachengqi decoction combined with conventional therapy', 'modified Dachengqi decoction combined with conventional therapy']","['gastrointestinal function score, total score of the acute physiology and chronic health evaluation II (APACHE II), and the pain score of the visual analog scale (VAS', 'TG, serum amylase, leukocyte count, and neutrophil ratio', 'cure rate and the total effective rate']","[{'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0030920', 'cui_str': 'Peptic ulcer'}, {'cui': 'C0020005', 'cui_str': 'County Hospitals'}]","[{'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1311504', 'cui_str': 'dachengqi decoction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0243028', 'cui_str': 'Acute physiology and chronic health evaluation II'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201885', 'cui_str': 'Amylase measurement, serum'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",40.0,0.0187697,"After treatment, the cure rate and the total effective rate were 60% and 95% respectively in the intervention group, and 25% and 75% respectively in the control group (P<0.05).","[{'ForeName': 'Guoxiong', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedics, the First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang, China. zgliuguoxiong@163.com.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedics, the First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Orthopedics, the First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang, China.'}, {'ForeName': 'Qiaogui', 'Initials': 'Q', 'LastName': 'Kuang', 'Affiliation': 'College of Acupuncture and Orthopedics, Guizhou University of Traditional Chinese Medicine, Guiyang, China.'}, {'ForeName': 'Xingfeng', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Orthopedics, the First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Puding County Hospital of Traditional Chinese Medicine, Anshun, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Puding County Hospital of Traditional Chinese Medicine, Anshun, China.'}]",Annals of palliative medicine,['10.21037/apm-20-1106']
1543,32692240,Effectiveness of a multidisciplinary comprehensive intervention model based on the Hospital Elderly Life Program to prevent delirium in patients with severe acute pancreatitis.,"BACKGROUND


Pancreatic encephalopathy is the most serious complication of severe acute pancreatitis (SAP) and substantially increases mortality. Delirium is a common clinical manifestation of pancreatic encephalopathy. This study aimed to assess the clinical effects of an improved version of the Hospital Elderly Life Program (HELP) on preventing delirium in elderly patients with SAP.
METHODS


A total of 106 patients with SAP aged 70 years or older were randomly divided into an experimental group (53 cases) and a control group (53 cases). The experimental group was given 2 weeks of conventional nursing combined with the HELP regimen, while the control group was given 2 weeks of conventional nursing. Conventional nursing included disease care, geriatric syndrome care and observation of critically ill patients. The incidence of delirium, severity of delirium, self-care ability, cognitive function, length of hospital stay, and patient satisfaction were compared between the 2 groups before and after the intervention.
RESULTS


The incidence of delirium was 4.00% in the experimental group and 16.98% in the control group; the difference was statistically significant (P=0.033). After 2 weeks of intervention, the experimental group showed significantly better self-care ability and cognitive function, shorter hospital stay, and greater patient satisfaction than the control group (all P<0.05).
CONCLUSIONS


The improved HELP protocol for elderly patients with SAP can reduce the incidence and severity of delirium, improve self-care ability and cognitive function, shorten hospital stay, and increase patient satisfaction.",2020,"After 2 weeks of intervention, the experimental group showed significantly better self-care ability and cognitive function, shorter hospital stay, and greater patient satisfaction than the control group (all P<0.05).
","['patients with severe acute pancreatitis', '106 patients with SAP aged 70 years or older', 'critically ill patients', 'elderly patients with SAP']","['conventional nursing combined with the HELP regimen', 'Hospital Elderly Life Program (HELP', 'multidisciplinary comprehensive intervention model']","['better self-care ability and cognitive function, shorter hospital stay, and greater patient satisfaction', 'incidence of delirium, severity of delirium, self-care ability, cognitive function, length of hospital stay, and patient satisfaction', 'incidence of delirium', 'mortality', 'incidence and severity of delirium, improve self-care ability and cognitive function, shorten hospital stay, and increase patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0562734', 'cui_str': 'Ability to perform personal care activity'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",106.0,0.0291091,"After 2 weeks of intervention, the experimental group showed significantly better self-care ability and cognitive function, shorter hospital stay, and greater patient satisfaction than the control group (all P<0.05).
","[{'ForeName': 'Zhixia', 'Initials': 'Z', 'LastName': 'Dong', 'Affiliation': 'Department of Gastroenterology, the Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Department of Gastroenterology, the Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': 'Minhua', 'Initials': 'M', 'LastName': 'Ge', 'Affiliation': 'Department of Gastroenterology, the Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': 'Department of Gastroenterology, the Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Hepatobiliary, the Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Hepatobiliary, the Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': 'Yanmin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Gastroenterology, the Affiliated Hospital of Jiangnan University, Wuxi, China. 396285432@qq.com.'}]",Annals of palliative medicine,['10.21037/apm-20-913']
1544,32692244,The appropriate dose of propofol for anesthesia induction in morbidly obese patients.,"BACKGROUND


To investigate the optimal dose of propofol in patients with morbid obesity when the anesthetic induction dosage is calculated based on lean body weight (LBW).
METHODS


Forty morbid obese patients with body mass index (BMI) ≥35 kg/m2 were randomly divided into two groups: B and M. The sequential method was used in group B to study the EC50 and 95% confidence interval (CI) that met a bispectral index (BIS) value of <50 (the initial dose was set at 2.5 mg/kg). The sequential method was used in group M to obtain the EC50 and 95% CI (the initial dose was set as 3.0 mg/kg) satisfying the mean arterial pressure (MAP) fluctuation margin of >40%. The optimal dose interval of propofol was obtained by synthetically analyzing the results of the two-sequence method.
RESULTS


There was no significant difference in the general condition between the two groups (P>0.05). There was no significant change in vital signs from when patients entered the operating room to when sufentanil was infused (P>0.05). The probit model of group B was Y=-5.411+2.343X, the EC50 of positive reaction with BIS <50 was 2.310 mg/kg, and 95% CI was 1.850-2.883 mg/kg. The probit model in the M group was Y=3.275 - 0.918X, the EC50 of positive reaction that reached >40% of the whole process of anesthetic induction was 3.567 mg/kg, and 95% CI was 1.233-7.165 mg/kg.
CONCLUSIONS


The appropriate dosage of propofol was 2.310-3.567 mg/kg when the anesthetic induction dosage for patients with morbid obesity was calculated based on LBW. With this dose, the depth of intubation is satisfactory and the hemodynamics are stable.",2020,There was no significant difference in the general condition between the two groups (P>0.05).,"['morbidly obese patients', 'patients with morbid obesity', 'Forty morbid obese patients with body mass index']","['sufentanil', 'propofol']","['general condition', 'mean arterial pressure (MAP) fluctuation margin', 'bispectral index (BIS) value', 'vital signs']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}]",40.0,0.023511,There was no significant difference in the general condition between the two groups (P>0.05).,"[{'ForeName': 'Guiping', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': ""Department of Anesthesiology, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China. xgpsyl@126.com.""}, {'ForeName': 'Nannan', 'Initials': 'N', 'LastName': 'Qiao', 'Affiliation': ""Department of Anesthesiology, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China.""}, {'ForeName': 'Yangyang', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': ""Department of Anesthesiology, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China.""}, {'ForeName': 'Alimujiang', 'Initials': 'A', 'LastName': 'Simayi', 'Affiliation': ""Department of Anesthesiology, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China.""}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesiology, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China.""}]",Annals of palliative medicine,['10.21037/apm-20-1223']
1545,32692245,Clinical research of percutaneous spinal nerve posteromedial ramus destruction in treatment for chronic facet arthrogenic low back pain: a randomized trial.,"BACKGROUND


To investigate the clinical effect of percutaneous spinal nerve posteromedial ramus destruction in treatment for chronic facet arthrogenic low back pain.
METHODS


A total of 118 patients with chronic facet arthrogenic low back pain were enrolled in our hospital from October 2015 to October 2018 and randomly divided into two groups. Of these patients, 59 received conservative treatment as the control group while 59 patients were treated with percutaneous spinal nerve posteromedial ramus destruction as the observation group. Pain score (Visual Analogue Scale, VAS), functional score (Oswestry Disability Index, ODI), treatment score (Japanese Orthopaedic Association, JOA), life quality score (Short Form 36-item Health Survey, SF-36), and lumbar mobility (range of motion, ROM) were evaluated before and after treatment. The treatment effect between two groups was compared.
RESULTS


The VAS score and ODI score at 2, 4, and 12 weeks after treatment and last follow-up in the observation group were lower than those of the control group (P<0.05). JOA score, SF-36, and ROM were higher than those of the control group (P<0.05).
CONCLUSIONS


Percutaneous spinal nerve posteromedial ramus destruction has a significant effect in treatment for chronic facet arthrogenic low back pain, which can relieve pain, improve function, and enhance quality of life.",2020,"JOA score, SF-36, and ROM were higher than those of the control group (P<0.05).
","['chronic facet arthrogenic low back pain', '118 patients with chronic facet arthrogenic low back pain were enrolled in our hospital from October 2015 to October 2018 and randomly divided into two groups']","['percutaneous spinal nerve posteromedial ramus destruction as the observation group', 'percutaneous spinal nerve posteromedial ramus destruction']","['Pain score (Visual Analogue Scale, VAS), functional score (Oswestry Disability Index, ODI), treatment score (Japanese Orthopaedic Association, JOA), life quality score (Short Form 36-item Health Survey, SF-36), and lumbar mobility (range of motion, ROM', 'VAS score and ODI score', 'JOA score, SF-36, and ROM']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0037941', 'cui_str': 'Spinal nerve structure'}, {'cui': 'C1261381', 'cui_str': 'Destructive procedure'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}]",118.0,0.0287034,"JOA score, SF-36, and ROM were higher than those of the control group (P<0.05).
","[{'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': 'The 908th Hospital of Chinese PLA, Nanchang, China.'}, {'ForeName': 'Qiujin', 'Initials': 'Q', 'LastName': 'Xiao', 'Affiliation': 'The 908th Hospital of Chinese PLA, Nanchang, China.'}, {'ForeName': 'Yinchu', 'Initials': 'Y', 'LastName': 'Shao', 'Affiliation': 'The 908th Hospital of Chinese PLA, Nanchang, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'The 908th Hospital of Chinese PLA, Nanchang, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'The 908th Hospital of Chinese PLA, Nanchang, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'The 908th Hospital of Chinese PLA, Nanchang, China.'}, {'ForeName': 'Guoyun', 'Initials': 'G', 'LastName': 'Bu', 'Affiliation': 'The 908th Hospital of Chinese PLA, Nanchang, China. 517730611@qq.com.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'The 908th Hospital of Chinese PLA, Nanchang, China. 47160843@qq.com.'}]",Annals of palliative medicine,['10.21037/apm-20-1374']
1546,32698329,Effect of a Cognitive Training Program on the Platelet APP Ratio in Patients with Alzheimer's Disease.,"In patients with Alzheimer's disease (AD), synaptic plasticity seems to be involved in cognitive improvement induced by cognitive training. The platelet amyloid precursor protein (APP) ratio (APPr), i.e., the ratio between two APP isoforms, may be a useful peripheral biomarker to investigate synaptic plasticity pathways. This study evaluates the changes in neuropsychological/cognitive performance and APPr induced by cognitive training in AD patients participating in the ""My Mind Project"". Neuropsychological/cognitive variables and APPr were evaluated in the trained group ( n  = 28) before a two-month experimental protocol, immediately after its termination at follow-up 1 (FU1), after 6 months at follow-up 2 (FU2), and after 24 months at follow-up 3 (FU3). The control group ( n  = 31) received general psychoeducational training for two months. Some memory and attention parameters were significantly improved in trained vs. control patients at FU1 and FU2 compared to baseline (Δ values). At FU3, APPr and Mini Mental State Examination (MMSE) scores decreased in trained patients. Δ APPr correlated significantly with the Δ scores of (i) MMSE at FU1, (ii) the prose memory test at FU2, and (iii) Instrumental Activities of Daily Living (IADL), the semantic word fluency test, Clinical Dementia Rating (CDR), and the attentive matrices test at FU3. Our data demonstrate that the platelet APPr correlates with key clinical variables, thereby proving that it may be a reliable biomarker of brain function in AD patients.",2020,Some memory and attention parameters were significantly improved in trained vs. control patients at FU1 and FU2 compared to baseline (Δ values).,"[""Patients with Alzheimer's Disease"", ""patients with Alzheimer's disease (AD"", 'AD patients', 'AD patients participating in the ""My Mind Project']","['cognitive training', 'general psychoeducational training', 'Cognitive Training Program']","['Some memory and attention parameters', 'Neuropsychological/cognitive variables and APPr', 'Instrumental Activities of Daily Living (IADL), the semantic word fluency test, Clinical Dementia Rating (CDR', 'prose memory test at FU2, and (iii', 'Platelet APP Ratio', 'platelet amyloid precursor protein (APP) ratio (APPr', 'At FU3, APPr and Mini Mental State Examination', 'MMSE) scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451074', 'cui_str': 'Clinical dementia rating scale'}, {'cui': 'C0021024', 'cui_str': 'Immunoglobulin, hypervariable region'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0085151', 'cui_str': 'Amyloid beta Precursor Protein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0170945,Some memory and attention parameters were significantly improved in trained vs. control patients at FU1 and FU2 compared to baseline (Δ values).,"[{'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Casoli', 'Affiliation': 'Center for Neurobiology of Aging, IRCCS INRCA, 60121 Ancona, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Giuli', 'Affiliation': 'Geriatrics Operative Unit, IRCCS INRCA, 63023 Fermo, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Balietti', 'Affiliation': 'Center for Neurobiology of Aging, IRCCS INRCA, 60121 Ancona, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Fabbietti', 'Affiliation': 'Unit of Geriatric Pharmacoepidemiology, IRCCS INRCA, 87100 Cosenza, Italy.'}, {'ForeName': 'Fiorenzo', 'Initials': 'F', 'LastName': 'Conti', 'Affiliation': 'Center for Neurobiology of Aging, IRCCS INRCA, 60121 Ancona, Italy.'}]",International journal of molecular sciences,['10.3390/ijms21145110']
1547,32697957,"Effects of long-term concurrent training to failure or not in muscle power output, muscle quality and cardiometabolic risk factors in older men: A secondary analysis of a randomized clinical trial.","This study investigated the effects of concurrent training performed either with repetitions to failure or not to failure in muscle power, muscle quality (MQ), peak oxygen uptake (VO 2peak ), and visceral fat in older men. This is an ancillary analysis of a randomized controlled trial. 36 older men (mean age ± SD; 67.1 ± 5.1 years) were randomized into three groups: one performing repetitions to failure (RFG, n = 13), another performing repetitions not to failure and 50% of the repetitions of the RFG (NFG, n = 12), and third performing repetitions not to failure with equal training volume of the RFG (ENFG, n = 11). The training was performed twice a week for 20 weeks at intensities ranging from 65 to 80% of maximal strength. In each session, the individuals started with strengthening exercises and then performed aerobic exercise (i.e., walking) on a treadmill. The primary endpoint was change from baseline to post-20 wk of absolute and relative muscle power output during squat and countermovement jump, ultrasound measurements for MQ using quadriceps echo intensity, and visceral fat thickness, as well as their VO 2peak  through a maximal incremental test on a treadmill. All training groups improved similarly and significantly jump height (ranging from 9 to 16%) and all their muscle power outcomes (mean change ranging from 2 to 7%) (P < .001). In addition, all groups significantly decreased visceral fat thickness (ranging from -11 to -21%) (P < .001), and significantly increased VO 2peak  (ranging from 4 to 8%) (P < .01), with no differences between groups. No changes were observed in the MQ outcomes. Concurrent training performed using repetitions to failure or not to failure promoted similar gains in the muscle power output, aerobic capacity, and visceral fat in healthy older men.",2020,All training groups improved similarly and significantly jump height (ranging from 9 to 16%) and all their muscle power outcomes (mean change ranging from 2 to 7%) (P < .001).,"['36 older men (mean age\u202f±\u202fSD; 67.1\u202f±\u202f5.1\u202fyears', 'healthy older men', 'older men']","['another performing repetitions not to failure and 50% of the repetitions of the RFG (NFG, n\u202f=\u202f12), and third performing repetitions not to failure with equal training volume of the RFG (ENFG, n', 'strengthening exercises and then performed aerobic exercise (i.e., walking) on a treadmill']","['VO 2peak', 'visceral fat thickness', 'MQ outcomes', 'muscle power output, muscle quality and cardiometabolic risk factors', 'change from baseline to post-20\u202fwk of absolute and relative muscle power output during squat and countermovement jump, ultrasound measurements for MQ using quadriceps echo intensity, and visceral fat thickness, as well as their VO 2peak  through a maximal incremental test on a treadmill', 'jump height', 'muscle power, muscle quality (MQ), peak oxygen uptake (VO 2peak ), and visceral fat']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}]","[{'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",36.0,0.0273081,All training groups improved similarly and significantly jump height (ranging from 9 to 16%) and all their muscle power outcomes (mean change ranging from 2 to 7%) (P < .001).,"[{'ForeName': 'Juliana L', 'Initials': 'JL', 'LastName': 'Teodoro', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Larissa X N', 'Initials': 'LXN', 'LastName': 'da Silva', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Bruno M', 'Initials': 'BM', 'LastName': 'Baroni', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Grazioli', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Lopez', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Carolina G', 'Initials': 'CG', 'LastName': 'Fritsch', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Régis', 'Initials': 'R', 'LastName': 'Radaelli', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Mikel L', 'Initials': 'ML', 'LastName': 'Saez de Asteasu', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil; Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Martim', 'Initials': 'M', 'LastName': 'Bottaro', 'Affiliation': 'College of Physical Education, University of Brasilia, Brasília, DF, Brazil.'}, {'ForeName': 'Juliano', 'Initials': 'J', 'LastName': 'Farinha', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Ronei S', 'Initials': 'RS', 'LastName': 'Pinto', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Eduardo L', 'Initials': 'EL', 'LastName': 'Cadore', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil. Electronic address: edu.cadore@ufrgs.br.'}]",Experimental gerontology,['10.1016/j.exger.2020.111023']
1548,32702309,"Pathological response in children and adults with large unresected intermediate-grade or high-grade soft tissue sarcoma receiving preoperative chemoradiotherapy with or without pazopanib (ARST1321): a multicentre, randomised, open-label, phase 2 trial.","BACKGROUND


Outcomes for children and adults with advanced soft tissue sarcoma are poor with traditional therapy. We investigated whether the addition of pazopanib to preoperative chemoradiotherapy would improve pathological near complete response rate compared with chemoradiotherapy alone.
METHODS


In this joint Children's Oncology Group and NRG Oncology multicentre, randomised, open-label, phase 2 trial, we enrolled eligible adults (aged ≥18 years) and children (aged between 2 and <18 years) from 57 hospitals in the USA and Canada with unresected, newly diagnosed trunk or extremity chemotherapy-sensitive soft tissue sarcoma, which were larger than 5 cm in diameter and of intermediate or high grade. Eligible patients had Lansky (if aged ≤16 years) or Karnofsky (if aged >16 years) performance status score of at least 70. Patients received ifosfamide (2·5 g/m 2  per dose intravenously on days 1-3 with mesna) and doxorubicin (37·5 mg/m 2  per dose intravenously on days 1-2) with 45 Gy preoperative radiotherapy, followed by surgical resection at week 13. Patients were randomly assigned (1:1) using a web-based system, in an unmasked manner, to receive oral pazopanib (if patients <18 years 350 mg/m 2  once daily; if patients ≥18 years 600 mg once daily) or not (control group), with pazopanib not given immediately before or after surgery at week 13. The study projected 100 randomly assigned patients were needed to show an improvement in the number of participants with a 90% or higher pathological response at week 13 from 40% to 60%. Analysis was done per protocol. This study has completed accrual and is registered with ClinicalTrials.gov, NCT02180867.
FINDINGS


Between July 7, 2014, and Oct 1, 2018, 81 eligible patients were enrolled and randomly assigned to the pazopanib group (n=42) or the control group (n=39). At the planned second interim analysis with 42 evaluable patients and a median follow-up of 0·8 years (IQR 0·3-1·6) in the pazopanib group and 1 year (0·3-1·6) in the control group, the number of patients with a 90% pathological response or higher was 14 (58%) of 24 patients in the pazopanib group and four (22%) of 18 patients in the control group, with a between-group difference in the number of 90% or higher pathological response of 36·1% (83·8% CI 16·5-55·8). On the basis of an interim analysis significance level of 0·081 (overall one-sided significance level of 0·20, power of 0·80, and O'Brien-Fleming-type cumulative error spending function), the 83·8% CI for response difference was between 16·5% and 55·8% and thus excluded 0. The improvement in pathological response rate with the addition of pazopanib crossed the predetermined boundary and enrolment was stopped. The most common grade 3-4 adverse events were leukopenia (16 [43%] of 37 patients), neutropenia (15 [41%]), and febrile neutropenia (15 [41%]) in the pazopanib group, and neutropenia (three [9%] of 35 patients) and febrile neutropenia (three [9%]) in the control group. 22 (59%) of 37 patients in the pazopanib group had a pazopanib-related serious adverse event. Paediatric and adult patients had a similar number of grade 3 and 4 toxicity. There were seven deaths (three in the pazopanib group and four in the control group), none of which were treatment related.
INTERPRETATION


In this presumed first prospective trial of soft tissue sarcoma spanning nearly the entire age spectrum, adding pazopanib to neoadjuvant chemoradiotherapy improved the rate of pathological near complete response, suggesting that this is a highly active and feasible combination in children and adults with advanced soft tissue sarcoma. The comparison of survival outcomes requires longer follow-up.
FUNDING


National Institutes of Health, St Baldrick's Foundation, Seattle Children's Foundation.",2020,"The most common grade 3-4 adverse events were leukopenia (16 [43%] of 37 patients), neutropenia (15 [41%]), and febrile neutropenia (15 [41%]) in the pazopanib group, and neutropenia (three [9%] of 35 patients) and febrile neutropenia (three [9%]) in the control group.","['Between July 7, 2014, and Oct 1, 2018, 81 eligible patients', 'Eligible patients had Lansky (if aged ≤16 years) or Karnofsky (if aged >16 years) performance status score of at least 70', 'children and adults with advanced soft tissue sarcoma', 'enrolled eligible adults (aged ≥18 years) and children (aged between 2 and <18 years) from 57 hospitals in the USA and Canada with unresected, newly diagnosed trunk or extremity chemotherapy-sensitive soft tissue sarcoma, which were larger than 5 cm in diameter and of intermediate or high grade', 'group (n=42) or the control group (n=39', 'children and adults with large unresected intermediate-grade or high-grade soft tissue sarcoma receiving']","['pazopanib', 'pazopanib to neoadjuvant chemoradiotherapy', 'doxorubicin (37·5 mg/m 2  per dose intravenously on days 1-2) with 45 Gy preoperative radiotherapy', 'ifosfamide', 'pazopanib to preoperative chemoradiotherapy', 'oral pazopanib', 'preoperative chemoradiotherapy with or without pazopanib (ARST1321']","['pazopanib-related serious adverse event', 'febrile neutropenia', 'neutropenia', 'grade 3 and 4 toxicity', 'Pathological response', 'pathological response rate', 'pathological response', 'leukopenia']","[{'cui': 'C1442824', 'cui_str': 'POU2F1 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0020823', 'cui_str': 'Ifosfamide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}]",100.0,0.19607,"The most common grade 3-4 adverse events were leukopenia (16 [43%] of 37 patients), neutropenia (15 [41%]), and febrile neutropenia (15 [41%]) in the pazopanib group, and neutropenia (three [9%] of 35 patients) and febrile neutropenia (three [9%]) in the control group.","[{'ForeName': 'Aaron R', 'Initials': 'AR', 'LastName': 'Weiss', 'Affiliation': 'Department of Pediatrics, Maine Medical Center, Portland, ME, USA. Electronic address: weissa2@mmc.org.'}, {'ForeName': 'Yen-Lin', 'Initials': 'YL', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Scharschmidt', 'Affiliation': ""Department of Orthopaedics, James Cancer Hospital and Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Yueh-Yun', 'Initials': 'YY', 'LastName': 'Chi', 'Affiliation': 'Department of Pediatrics and Preventative Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Department of Biostatistics, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Jennifer O', 'Initials': 'JO', 'LastName': 'Black', 'Affiliation': ""Department of Pathology, Children's Hospital Colorado, Aurora, CO, USA.""}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Davis', 'Affiliation': 'Department of Pathology, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Fanburg-Smith', 'Affiliation': ""Department of Pathology, Penn State Children's Hospital, Hershey, PA, USA.""}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Zambrano', 'Affiliation': 'Department of Pathology, Rocky Mountain Hospital for Children, Presbyterian St Luke Medical Centre, Denver, CO, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Anderson', 'Affiliation': 'Department of Biostatistics and Research Decision Sciences, Merck and Co, North Wales, PA, USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Arens', 'Affiliation': ""Department of Clinical Trials, Connecticut Children's Medical Center, Hartford, CT, USA.""}, {'ForeName': 'Odion', 'Initials': 'O', 'LastName': 'Binitie', 'Affiliation': 'Department of Sarcoma, Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Choy', 'Affiliation': 'Department of Medical Oncology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Justin W', 'Initials': 'JW', 'LastName': 'Davis', 'Affiliation': ""Children's Oncology Group, Monrovia, CA, USA.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hayes-Jordan', 'Affiliation': 'Department of Surgery, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.'}, {'ForeName': 'Simon C', 'Initials': 'SC', 'LastName': 'Kao', 'Affiliation': 'Department of Radiology, University of Iowa Carver College of Medicine, Iowa City, IA, USA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Kayton', 'Affiliation': ""Department of Surgery, Palm Beach Children's Hospital, St Mary's Medical Center, Florida Atlantic University, West Palm Beach, FL, USA.""}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Kessel', 'Affiliation': 'Imaging and Radiation Oncology Core Rhode Island, Lincoln, RI, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Lim', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Meyer', 'Affiliation': 'Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Million', 'Affiliation': 'Department of Radiation Oncology, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Okuno', 'Affiliation': 'Department of Oncology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ostrenga', 'Affiliation': 'Department of Pharmacy, University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': 'Marguerite T', 'Initials': 'MT', 'LastName': 'Parisi', 'Affiliation': ""Department of Radiology and Pediatrics, University of Washington School of Medicine and Seattle Children's Hospital, Seattle, WA, USA.""}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Pryma', 'Affiliation': 'Department of Radiology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'R Lor', 'Initials': 'RL', 'LastName': 'Randall', 'Affiliation': 'Department of Orthopaedic Surgery, University of California Davis, Sacramento, CA, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Rosen', 'Affiliation': 'Department of Radiology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Schlapkohl', 'Affiliation': 'Department of Pediatrics, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Barry L', 'Initials': 'BL', 'LastName': 'Shulkin', 'Affiliation': ""Department of Diagnostic Imaging, St Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Ethan A', 'Initials': 'EA', 'LastName': 'Smith', 'Affiliation': ""Department of Radiology and Medical Imaging, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Joel I', 'Initials': 'JI', 'LastName': 'Sorger', 'Affiliation': ""Department of Orthopaedic Surgery, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Terezakis', 'Affiliation': 'Department of Radiation Oncology, University of Minnesota, Masonic Cancer Center, Minneapolis, MN, USA.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Hawkins', 'Affiliation': ""Department of Pediatrics, University of Washington School of Medicine and Seattle Children's Hospital, Seattle, WA, USA.""}, {'ForeName': 'Sheri L', 'Initials': 'SL', 'LastName': 'Spunt', 'Affiliation': 'Department of Pediatrics, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Dian', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, Rush University Medical Center, Chicago, IL, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30325-9']
1549,32701954,Effectiveness and cost-effectiveness of the GoActive intervention to increase physical activity among UK adolescents: A cluster randomised controlled trial.,"BACKGROUND


Less than 20% of adolescents globally meet recommended levels of physical activity, and not meeting these recommended levels is associated with social disadvantage and rising disease risk. The determinants of physical activity in adolescents are multilevel and poorly understood, but the school's social environment likely plays an important role. We conducted a cluster randomised controlled trial to assess the effectiveness of a school-based programme (GoActive) to increase moderate-to-vigorous physical activity (MVPA) among adolescents.
METHODS AND FINDINGS


Non-fee-paying, co-educational schools including Year 9 students in the UK counties of Cambridgeshire and Essex were eligible for inclusion. Within participating schools (n = 16), all Year 9 students were eligible and invited to participate. Participants were 2,862 13- to 14-year-olds (84% of eligible students). After baseline assessment, schools were computer-randomised, stratified by school-level pupil premium funding (below/above county-specific median) and county (control: 8 schools, 1,319 participants, mean [SD] participants per school n = 165 [62]; intervention: 8 schools, 1,543 participants, n = 193 [43]). Measurement staff were blinded to allocation. The iteratively developed, feasibility-tested 12-week intervention, aligned with self-determination theory, trained older adolescent mentors and in-class peer-leaders to encourage classes to conduct 2 new weekly activities. Students and classes gained points and rewards for engaging in any activity in or out of school. The primary outcome was average daily minutes of accelerometer-assessed MVPA at 10-month follow-up; a mixed-methods process evaluation evaluated implementation. Of 2,862 recruited participants (52.1% male), 2,167 (76%) attended 10-month follow-up measurements; we analysed the primary outcome for 1,874 participants (65.5%). At 10 months, there was a mean (SD) decrease in MVPA of 8.3 (19.3) minutes in the control group and 10.4 (22.7) minutes in the intervention group (baseline-adjusted difference [95% confidence interval] -1.91 minutes [-5.53 to 1.70], p = 0.316). The programme cost £13 per student compared with control; it was not cost-effective. Overall, 62.9% of students and 87.3% of mentors reported that GoActive was fun. Teachers and mentors commented that their roles in programme delivery were unclear. Implementation fidelity was low. The main methodological limitation of this study was the relatively affluent and ethnically homogeneous sample.
CONCLUSIONS


In this study, we observed that a rigorously developed school-based intervention was no more effective than standard school practice at preventing declines in adolescent physical activity. Interdisciplinary research is required to understand educational-setting-specific implementation challenges. School leaders and authorities should be realistic about expectations of the effect of school-based physical activity promotion strategies implemented at scale.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN31583496.",2020,The programme cost £13 per student compared with control; it was not cost-effective.,"['1,319 participants, mean [SD] participants per school n = 165 [62]; intervention: 8 schools, 1,543 participants, n = 193 [43', 'Non-fee-paying, co-educational schools including Year 9 students in the UK counties of Cambridgeshire and Essex were eligible for inclusion', 'Of 2,862 recruited participants (52.1% male), 2,167 (76%) attended 10-month follow-up measurements; we analysed the primary outcome for 1,874 participants (65.5', 'Within participating schools (n = 16), all Year 9 students were eligible and invited to participate', 'UK adolescents', 'Participants were 2,862 13- to 14-year-olds (84% of eligible students', 'adolescents']","['school-based programme (GoActive', 'GoActive intervention']","['average daily minutes of accelerometer-assessed MVPA', 'physical activity', 'Effectiveness and cost-effectiveness', 'moderate-to-vigorous physical activity (MVPA', 'mean (SD) decrease in MVPA']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015751', 'cui_str': 'Fees'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0454843', 'cui_str': 'Cambridgeshire'}, {'cui': 'C0454853', 'cui_str': 'Essex'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",2862.0,0.114617,The programme cost £13 per student compared with control; it was not cost-effective.,"[{'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Corder', 'Affiliation': 'UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Sharp', 'Affiliation': 'UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Stephanie T', 'Initials': 'ST', 'LastName': 'Jong', 'Affiliation': 'UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Campbell', 'Initials': 'C', 'LastName': 'Foubister', 'Affiliation': 'UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Helen Elizabeth', 'Initials': 'HE', 'LastName': 'Brown', 'Affiliation': 'UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Emma K', 'Initials': 'EK', 'LastName': 'Wells', 'Affiliation': 'UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Sofie M', 'Initials': 'SM', 'LastName': 'Armitage', 'Affiliation': 'UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Caroline H D', 'Initials': 'CHD', 'LastName': 'Croxson', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Vignoles', 'Affiliation': 'Faculty of Education, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Paul O', 'Initials': 'PO', 'LastName': 'Wilkinson', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Edward C F', 'Initials': 'ECF', 'LastName': 'Wilson', 'Affiliation': 'Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Esther M F', 'Initials': 'EMF', 'LastName': 'van Sluijs', 'Affiliation': 'UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, United Kingdom.'}]",PLoS medicine,['10.1371/journal.pmed.1003210']
1550,32708930,The Effects of Loaded Plyometric Exercise during Warm-Up on Subsequent Sprint Performance in Collegiate Track Athletes: A Randomized Trial.,"Prior evidence demonstrates the efficacy by which plyometric activities during warm-up conditions augment the subsequent performance in power-centric exercise. We investigated the acute effects of loaded jump squats incorporated into a standard sprinters' warm-up protocol on subsequent sprint performance in collegiate track athletes. Sprint times of 22 male and female collegiate track athletes were measured in 10-m intervals during a 30-m sprint trial following a standard sprinters' warm-up routine with or without plyometric exercise. Subjects were tested on two separate occasions, once with loaded jump squats as the experimental treatment (two sets of eight jumps, load = 13% bodyweight) (PLYO) and once with time-equated rest as the control treatment (CON). Treatments were implemented following a standard sprinters' warm-up routine familiar to the subjects. A dependent T-test was used for comparison of sprint interval times between conditions with a significant effect indicated by a  p -value < 0.05. Sprint time did not differ between CON vs. PLYO at the 10 m (PLYO = 1.90 ± 0.12 s vs. CON = 1.90 ± 0.11 s,  p  = 0.66), 20 m (PLYO = 3.16 ± 0.21 s vs. CON = 3.15 ± 0.19 s,  p  = 0.53), and 30 m (PLYO = 4.32 ± 0.32 s vs. CON = 4.31 ± 0.28 s,  p  = 0.61) intervals. There was no interaction between treatment and sex, sex-specific ranking (above vs. below sex-specific mean), or sprint event (short vs. short-long vs. long) for 10 m, 20 m, or 30-m interval sprint times. At least within the limits of the current investigation, no evidence was provided to suggest that jump squats loaded at 13% bodyweight are an effective means to acutely potentiate sprint performance in collegiate track athletes. However, a further examination of responders indicates that the present loaded jump squat protocol may preferentially potentiate sprint performance in faster male athletes.",2020,"Sprint time did not differ between CON vs. PLYO at the 10 m (PLYO = 1.90 ± 0.12 s vs. CON = 1.90 ± 0.11 s,  p  = 0.66), 20 m (PLYO = 3.16 ± 0.21 s vs. CON = 3.15 ± 0.19 s,  p  = 0.53), and 30 m (PLYO = 4.32 ± 0.32 s vs. CON = 4.31 ± 0.28 s,  p  = 0.61) intervals.","['22 male and female collegiate track athletes', 'Collegiate Track Athletes', 'faster male athletes', 'collegiate track athletes']","[""standard sprinters' warm-up routine with or without plyometric exercise"", 'Loaded Plyometric Exercise']","['sprint performance', 'Sprint time']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}]",22.0,0.0364633,"Sprint time did not differ between CON vs. PLYO at the 10 m (PLYO = 1.90 ± 0.12 s vs. CON = 1.90 ± 0.11 s,  p  = 0.66), 20 m (PLYO = 3.16 ± 0.21 s vs. CON = 3.15 ± 0.19 s,  p  = 0.53), and 30 m (PLYO = 4.32 ± 0.32 s vs. CON = 4.31 ± 0.28 s,  p  = 0.61) intervals.","[{'ForeName': 'Kalin A', 'Initials': 'KA', 'LastName': 'Tomlinson', 'Affiliation': 'Human Performance Research Laboratory, Department of Kinesiology and Health Promotion, California State Polytechnic University, Pomona, CA 91768, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Hansen', 'Affiliation': 'Human Performance Research Laboratory, Department of Kinesiology and Health Promotion, California State Polytechnic University, Pomona, CA 91768, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Helzer', 'Affiliation': 'Human Performance Research Laboratory, Department of Kinesiology and Health Promotion, California State Polytechnic University, Pomona, CA 91768, USA.'}, {'ForeName': 'Zakkoyya H', 'Initials': 'ZH', 'LastName': 'Lewis', 'Affiliation': 'Human Performance Research Laboratory, Department of Kinesiology and Health Promotion, California State Polytechnic University, Pomona, CA 91768, USA.'}, {'ForeName': 'Whitney D', 'Initials': 'WD', 'LastName': 'Leyva', 'Affiliation': 'Human Performance Research Laboratory, Department of Kinesiology and Health Promotion, California State Polytechnic University, Pomona, CA 91768, USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'McCauley', 'Affiliation': 'Human Performance Research Laboratory, Department of Kinesiology and Health Promotion, California State Polytechnic University, Pomona, CA 91768, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Pritchard', 'Affiliation': 'Human Performance Research Laboratory, Department of Kinesiology and Health Promotion, California State Polytechnic University, Pomona, CA 91768, USA.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Silvestri', 'Affiliation': 'Human Performance Research Laboratory, Department of Kinesiology and Health Promotion, California State Polytechnic University, Pomona, CA 91768, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Quila', 'Affiliation': 'Human Performance Research Laboratory, Department of Kinesiology and Health Promotion, California State Polytechnic University, Pomona, CA 91768, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Yi', 'Affiliation': 'Human Performance Research Laboratory, Department of Kinesiology and Health Promotion, California State Polytechnic University, Pomona, CA 91768, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Jo', 'Affiliation': 'Human Performance Research Laboratory, Department of Kinesiology and Health Promotion, California State Polytechnic University, Pomona, CA 91768, USA.'}]","Sports (Basel, Switzerland)",['10.3390/sports8070101']
1551,32708938,"Effectiveness of 6-Week Nordic Walking Training on Functional Performance, Gait Quality, and Quality of Life in Parkinson's Disease.","Background and objectives:  Motor rehabilitation improves physical mobility and quality of life in Parkinson's disease (PD). As specialized rehabilitation is expensive and resource-consuming, there is a need for simpler, cost-effective methods. The purpose of the study was to determine whether Nordic Walking (NW) training may support the management of motor disability in PD.  Materials and Methods:  Forty patients (median age 64.0 years, range 50-75 years) with idiopathic PD, Hoehn and Yahr stages II-III, were randomly assigned to NW or standard rehabilitation (SR) programs, comprising twelve rehabilitation sessions conducted bi-weekly throughout the 6-week study period.  Results:  Median Unified Parkinson's Disease Rating Scale part III scores were significantly reduced with NW, by 8.5, and with SR, by 6.0 points (both  p  < 0.001), with significantly greater improvement with NW than with SR ( p  = 0.047). Gait quality and balance control, measured using the Dynamic Gait Index, improved with NW by a median of 8.0 and with SR by 5.5 points (both  p  < 0.001), with slightly greater improvement with NW, compared to the SR group ( p  = 0.064). Quality of life, assessed using the Parkinson's Disease Questionnaire (PDQ-39), improved with NW by a median of 15 and with SR by 12 points,  p  = 0.001 and  p  = 0.008, respectively.  Conclusions:  The 6-week Nordic Walking program improves functional performance, quality of gait, and quality of life in patients with PD and has comparable effectiveness to standard rehabilitation.",2020,"Gait quality and balance control, measured using the Dynamic Gait Index, improved with NW by a median of 8.0 and with SR by 5.5 points (both  p  < 0.001), with slightly greater improvement with NW, compared to the SR group ( p  = 0.064).","['patients with PD', ""Parkinson's Disease"", ""Parkinson's disease (PD"", 'Forty patients (median age 64.0 years, range 50-75 years) with idiopathic PD, Hoehn and Yahr stages II-III']","['Nordic Walking program', 'Motor rehabilitation', 'NW or standard rehabilitation (SR) programs', '6-Week Nordic Walking Training', 'Nordic Walking (NW) training']","[""Quality of life, assessed using the Parkinson's Disease Questionnaire (PDQ-39"", ""Unified Parkinson's Disease Rating Scale part III scores"", 'Functional Performance, Gait Quality, and Quality of Life', 'Dynamic Gait Index', 'physical mobility and quality of life', 'Gait quality and balance control', 'functional performance, quality of gait, and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C2919794', 'cui_str': 'Dynamic gait index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0206053,"Gait quality and balance control, measured using the Dynamic Gait Index, improved with NW by a median of 8.0 and with SR by 5.5 points (both  p  < 0.001), with slightly greater improvement with NW, compared to the SR group ( p  = 0.064).","[{'ForeName': 'Justyna', 'Initials': 'J', 'LastName': 'Szefler-Derela', 'Affiliation': 'Department of Physiotherapy, School of Health Sciences in Katowice, Medical University of Silesia, 40-055 Katowice, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Arkuszewski', 'Affiliation': 'Institute for Innovative Medicine, 15-082 Białystok, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Knapik', 'Affiliation': 'Department of Adapted Physical Activity and Sport, School of Health Sciences in Katowice, Medical University of Silesia, 40-055 Katowice, Poland.'}, {'ForeName': 'Dagmara', 'Initials': 'D', 'LastName': 'Wasiuk-Zowada', 'Affiliation': 'Department of Physiotherapy, School of Health Sciences in Katowice, Medical University of Silesia, 40-055 Katowice, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Gorzkowska', 'Affiliation': 'Department of Neurology, Faculty of Medical Sciences in Katowice, Medical University of Silesia, 40-055 Katowice, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Krzystanek', 'Affiliation': 'Department of Neurology, Faculty of Medical Sciences in Katowice, Medical University of Silesia, 40-055 Katowice, Poland.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56070356']
1552,32615171,Unique skin abnormality in patients with peanut allergy but no atopic dermatitis.,"BACKGROUND


The nonlesional skin of children with atopic dermatitis (AD) with peanut allergy (PA) is associated with increased transepidermal water loss; low urocanic acid (UCA) and pyrrolidone carboxylic acid (PCA), both of which are filaggrin breakdown products; and a reduced ratio of esterified ω-hydroxy fatty acid sphingosine ceramides (EOS-CERs) to nonhydroxy fatty acid sphingosine ceramides (NS-CERs) in the skin. The skin barrier of subjects with PA without AD (AD - PA + ) has not been studied.
OBJECTIVE


Our aim was to explore whether AD - PA +  is associated with skin barrier abnormalities.
METHODS


A total of 33 participants were enrolled, including 13 AD - PA + , 9 AD + PA + , and 11 nonatopic (NA) participants.
RESULTS


The PCA content in the stratum corneum of AD - PA +  subjects was significantly reduced versus that in NA subjects (median level, 67 vs 97 μg/mg protein [P = .028]). The ratio between cis- and trans-UCA decreased significantly from being highest in the NA group (1.62) to lowest in AD + PA +  group (0.07 [P < .001 vs in the NA group; P = .006 vs in the AD - PA +  group]), with the AD - PA +  group having an intermediate cis/trans-UCA ratio (1.17 [P = .024 vs in the NA group]). The TEWL in AD - PA +  subjects did not differ from that in the group with NA skin. Interestingly, AD - PA +  subjects had an increased EOS/NS-CER ratio versus that in the group of subjects with NA skin (1.9 vs 1.3 [P = .008]), whereas the AD + PA +  group had a decreased proportion of EOS-CERs (0.8 [P = .001] vs in the AD - PA +  group).
CONCLUSION


Our data demonstrate that irrespective of AD, PA is associated with decreased skin cis-UCA and PCA content. An increase in skin EOS-CER/NS-CER ratio separates the AD - PA +  group from the AD + PA +  and NA groups.",2020,An increase in skin EOS-CER/NS-CER ratio separates the AD - PA +  group from the AD + PA +  and NA groups.,"['patients with peanut allergy but no atopic dermatitis', '33 participants were enrolled, including 13 AD - PA + , 9 AD + PA + , and 11 nonatopic (NA) participants', 'children with atopic dermatitis (AD) with peanut allergy (PA']",[],"['skin EOS-CER/NS-CER ratio separates', 'EOS/NS-CER ratio', 'proportion of EOS-CERs', 'ratio between cis- and trans-UCA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0559470', 'cui_str': 'Allergy to peanut'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",[],"[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0237504', 'cui_str': 'CER'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0007099', 'cui_str': 'Carcinoma in situ'}, {'cui': 'C0042054', 'cui_str': 'Urocanic acid'}]",33.0,0.0250653,An increase in skin EOS-CER/NS-CER ratio separates the AD - PA +  group from the AD + PA +  and NA groups.,"[{'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Berdyshev', 'Affiliation': 'Department of Medicine, National Jewish Health, Denver, Colo.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Goleva', 'Affiliation': 'Department of Pediatrics, National Jewish Health, Denver, Colo.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Bronova', 'Affiliation': 'Department of Medicine, National Jewish Health, Denver, Colo.'}, {'ForeName': 'Anna-Sofia', 'Initials': 'AS', 'LastName': 'Bronoff', 'Affiliation': 'Department of Pediatrics, National Jewish Health, Denver, Colo.'}, {'ForeName': 'Bryce C', 'Initials': 'BC', 'LastName': 'Hoffman', 'Affiliation': 'Department of Pediatrics, National Jewish Health, Denver, Colo.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Ramirez-Gama', 'Affiliation': 'Department of Pediatrics, National Jewish Health, Denver, Colo.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Garcia', 'Affiliation': 'Department of Pediatrics, National Jewish Health, Denver, Colo.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Crumrine', 'Affiliation': 'Department of Dermatology, VA Medical Center/University of California San Francisco, San Francisco, Calif.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Elias', 'Affiliation': 'Department of Dermatology, VA Medical Center/University of California San Francisco, San Francisco, Calif.'}, {'ForeName': 'Christine B', 'Initials': 'CB', 'LastName': 'Cho', 'Affiliation': 'Department of Pediatrics, National Jewish Health, Denver, Colo; Department of Pediatrics, University of Colorado, Denver, Colo.'}, {'ForeName': 'Donald Y M', 'Initials': 'DYM', 'LastName': 'Leung', 'Affiliation': 'Department of Pediatrics, National Jewish Health, Denver, Colo; Department of Pediatrics, University of Colorado, Denver, Colo. Electronic address: Leungd@njhealth.org.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.06.015']
1553,32707101,The Family Check-Up 4 Health: Study protocol of a randomized type II hybrid effectiveness-implementation trial in integrated primary care (the healthy communities 4 healthy students study).,"BACKGROUND


Parenting interventions like the Family Check-Up have demonstrated effects on child physical and behavioral health outcomes. However, access to these programs is limited, particularly for populations experiencing health disparities. Primary care settings have become recognized as a potential delivery system in which these programs may be implemented at scale. The purpose of this trial is to test the effectiveness of the Family Check-Up 4 Health (FCU4Health) program, an adaptation of the FCU for primary care, and assess program implementation in an integrated primary care setting.
METHODS


We will conduct a hybrid type 2 effectiveness-implementation trial in partnership with a primary care clinic in a low-income, majority Latino community. Families with 2- to 5-year-old children will be eligible to participate. Families will be randomized to receive the intervention (n = 130) or services as usual (n = 70) and will be assessed annually over three years. Outcomes are informed by the RE-AIM framework (i.e., reach, effectiveness, adoption, implementation, and maintenance). Effectiveness outcomes include child health behaviors (e.g., Dietary Screener Questionnaire), behavioral health (e.g., Strengths and Difficulties Questionnaire), and parenting (e.g., Proactive Parenting). Early stage implementation outcomes are also included (e.g., cost, acceptability, appropriateness, and feasibility). Effectiveness outcomes will be assessed via intent-to-treat (ITT) analyses. Implementation outcomes will be primarily descriptive with comparisons to prior trials of FCU4Health and the original FCU.
PROJECTED OUTCOMES


This trial will provide evidence related to the potential of integrated primary care settings to deliver evidence-based preventive interventions with a dual focus on behavioral and physical health.",2020,"The purpose of this trial is to test the effectiveness of the Family Check-Up 4 Health (FCU4Health) program, an adaptation of the FCU for primary care, and assess program implementation in an integrated primary care setting.
","['partnership with a primary care clinic in a low-income, majority Latino community', 'Families with 2- to 5-year-old children', 'integrated primary care (the healthy communities 4 healthy students study']",['Family Check-Up 4 Health (FCU4Health) program'],"['RE-AIM framework (i.e., reach, effectiveness, adoption, implementation, and maintenance', 'cost, acceptability, appropriateness, and feasibility', 'child health behaviors (e.g., Dietary Screener Questionnaire), behavioral health (e.g., Strengths and Difficulties Questionnaire), and parenting (e.g., Proactive Parenting']","[{'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0420160', 'cui_str': 'History and physical examination, school'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}]",,0.0514529,"The purpose of this trial is to test the effectiveness of the Family Check-Up 4 Health (FCU4Health) program, an adaptation of the FCU for primary care, and assess program implementation in an integrated primary care setting.
","[{'ForeName': 'Cady', 'Initials': 'C', 'LastName': 'Berkel', 'Affiliation': ""REACH Institute, Arizona State University, Tempe, AZ, USA; Phoenix Children's Hospital, Phoenix, AZ, USA. Electronic address: Cady.Berkel@asu.edu.""}, {'ForeName': 'Justin D', 'Initials': 'JD', 'LastName': 'Smith', 'Affiliation': 'Center for Prevention Implementation Methodology (Ce-PIM), Department of Psychiatry and Behavioral Sciences, Department of Preventive Medicine, Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Meg M', 'Initials': 'MM', 'LastName': 'Bruening', 'Affiliation': 'Department of Nutrition, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Jordan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Fu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Mauricio', 'Affiliation': 'REACH Institute, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Grimm', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Winslow', 'Affiliation': 'REACH Institute, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Ray', 'Affiliation': 'Bayless Integrated Healthcare, Phoenix, AZ, USA.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Bourne', 'Affiliation': 'Southwest Maricopa Regional Council, First Things First, Peoria, AZ, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Dishion', 'Affiliation': 'REACH Institute, Arizona State University, Tempe, AZ, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106088']
1554,32707159,Obesity blunts cephalic-phase microvascular responses to food.,"Neurally mediated anticipatory responses, also named cephalic-phase responses, and microcirculatory regulation are two important mechanisms to maintain metabolic homeostasis. Altered cephalic-phase responses in obesity and its metabolic consequences have been proposed. There is, however, a lack of studies focusing on in vivo assessment of the microcirculation during this phase in patients with obesity. In this randomized controlled trial, we selected patients with obesity and healthy subjects after clinical and laboratory assessments. Those with obesity were randomized into two groups: experimental (cephalic-phase microvascular response stimulation - CP group, n = 13) and controls (n = 14). Healthy subjects (n = 17) were also included to form a CP control group. Skin microvascular assessment was used as a model of systemic microcirculation. Resting functional capillary density (FCD) and peak FCD during post-occlusive reactive hyperemia (PORH) were measured by dorsal finger videocapillaroscopy and expressed mainly capillary recruitment capacity. Resting red blood cell velocity (RBCV), peak RBCV during PORH (RBCV max ), and time taken to reach RBCV max  (TRBCV max ) were assessed by dynamic nailfold videocapillaroscopy and expressed the microhemodynamics. Patients with obesity (with or without stimulus) failed to show an increase on FCD during PORH post-stimulus (p = 0.221 and p = 0.307, respectively) depicting lack of capillary recruitment. In contrast, healthy subjects presented an increase in this microvascular outcome (p = 0.004). Changes in all variables of microhemodynamics occurred in both CP groups (healthy and those with obesity). During CP, we originally demonstrated an absence of capillary recruitment in subjects with obesity. These findings might contribute to the literature of microvascular impairment and metabolic conditions.",2020,"Patients with obesity (with or without stimulus) failed to show an increase on FCD during PORH post-stimulus (p=0.221 and p=0.307, respectively) depicting lack of capillary recruitment.","['healthy subjects', 'Patients with obesity (with or without stimulus', 'group, n=13) and controls (n=14', 'patients with obesity', 'Healthy subjects (n=17) were also included to form a CP control group', 'subjects with obesity', 'patients with obesity and healthy subjects after clinical and laboratory assessments']",['experimental (cephalic-phase microvascular response stimulation - CP'],"['Resting red blood cell velocity (RBCV), peak RBCV during PORH (RBCV max ), and time taken to reach RBCV max  (TRBCV max ', 'microvascular outcome', 'Skin microvascular assessment', 'FCD during PORH post-stimulus', 'Resting functional capillary density (FCD) and peak FCD during post-occlusive reactive hyperemia (PORH']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1562113', 'cui_str': 'Fleck corneal dystrophy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0006901', 'cui_str': 'Structure of capillary blood vessel (organ)'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}]",17.0,0.0160267,"Patients with obesity (with or without stimulus) failed to show an increase on FCD during PORH post-stimulus (p=0.221 and p=0.307, respectively) depicting lack of capillary recruitment.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Buss', 'Affiliation': 'Department of Nutrition Federal University of Health Sciences of Porto Alegre (UFCSPA), RS, Brazil; Graduate Program in Health Sciences, UFCSPA, RS, Brazil. Electronic address: carolinebuss@ufcspa.edu.br.'}, {'ForeName': 'Priscila A', 'Initials': 'PA', 'LastName': 'Maranhão', 'Affiliation': 'Clinical and Experimental Research Laboratory on Vascular Biology (BioVasc) Biomedical Center, State University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil; Faculty of Medicine, Center for Research in Health Technologies and Information Systems (CINTESIS), University of Porto, Porto, Portugal.'}, {'ForeName': 'Maria das Graças C', 'Initials': 'MDGC', 'LastName': 'de Souza', 'Affiliation': 'Clinical and Experimental Research Laboratory on Vascular Biology (BioVasc) Biomedical Center, State University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Eliete', 'Initials': 'E', 'LastName': 'Bouskela', 'Affiliation': 'Clinical and Experimental Research Laboratory on Vascular Biology (BioVasc) Biomedical Center, State University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Luiz Guilherme', 'Initials': 'LG', 'LastName': 'Kraemer-Aguiar', 'Affiliation': 'Clinical and Experimental Research Laboratory on Vascular Biology (BioVasc) Biomedical Center, State University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil; Department of Internal Medicine Faculty of Medical Sciences, State University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113087']
1555,32720550,Neurally adjusted ventilatory assist after surgical treatment of intracerebral hemorrhage: a randomized crossover study.,"OBJECTIVE


We assessed the neuromechanical efficiency (NME), neuroventilatory efficiency (NVE), and diaphragmatic function effects between pressure support ventilation (PSV) and neutrally adjusted ventilatory assist (NAVA).
METHODS


Fifteen patients who had undergone surgical treatment of intracerebral hemorrhage were enrolled in this randomized crossover study. The patients were assigned to PSV for the first 24 hours and then to NAVA for the following 24 hours or vice versa. The monitored ventilatory parameters under the two ventilation models were compared. NME, NVE, and diaphragmatic function were compared between the two ventilation models.
RESULTS


One patient's illness worsened during the study. The study was stopped for this patient, and intact data were obtained from the other 14 patients and analyzed. The monitored tidal volume was significantly higher with PSV than NAVA (487 [443-615] vs. 440 [400-480] mL, respectively). NME, NVE, diaphragmatic function, and the partial pressures of arterial carbon dioxide and oxygen were not significantly different between the two ventilation models.
CONCLUSION


The tidal volume was lower with NAVA than PSV; however, the patients' selected respiratory pattern during NAVA did not change the NME, NVE, or diaphragmatic function.Clinical trial registration no. ChiCTR1900022861.",2020,"The monitored tidal volume was significantly higher with PSV than NAVA (487 [443-615] vs. 440 [400-480] mL, respectively).","['Fifteen patients who had undergone surgical treatment of intracerebral hemorrhage', 'intracerebral hemorrhage']","['pressure support ventilation (PSV) and neutrally adjusted ventilatory assist (NAVA', 'NAVA']","['tidal volume', 'NME, NVE, and diaphragmatic function', 'NME, NVE, or diaphragmatic function', 'neuromechanical efficiency (NME), neuroventilatory efficiency (NVE), and diaphragmatic function effects', 'NME, NVE, diaphragmatic function, and the partial pressures of arterial carbon dioxide and oxygen', 'monitored tidal volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}]","[{'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]",15.0,0.0392167,"The monitored tidal volume was significantly higher with PSV than NAVA (487 [443-615] vs. 440 [400-480] mL, respectively).","[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'Department of Neurosurgery, Research Center for Functional Maintenance and Reconstruction of Viscera, The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital), Wuhu, China.'}, {'ForeName': 'Rongrong', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'Department of Education, The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital), Wuhu, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yao', 'Affiliation': 'Department of Neurosurgery, Research Center for Functional Maintenance and Reconstruction of Viscera, The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital), Wuhu, China.'}, {'ForeName': 'Kui', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, Research Center for Functional Maintenance and Reconstruction of Viscera, The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital), Wuhu, China.'}, {'ForeName': 'Guiliang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, Research Center for Functional Maintenance and Reconstruction of Viscera, The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital), Wuhu, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': 'Department of Neurosurgery, Research Center for Functional Maintenance and Reconstruction of Viscera, The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital), Wuhu, China.'}, {'ForeName': 'Nianlong', 'Initials': 'N', 'LastName': 'Wu', 'Affiliation': 'Department of Neurosurgery, Research Center for Functional Maintenance and Reconstruction of Viscera, The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital), Wuhu, China.'}, {'ForeName': 'Xinggen', 'Initials': 'X', 'LastName': 'Fang', 'Affiliation': 'Department of Neurosurgery, Research Center for Functional Maintenance and Reconstruction of Viscera, The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital), Wuhu, China.'}]",The Journal of international medical research,['10.1177/0300060520939837']
1556,32725073,Restrictive versus Liberal Fluid Therapy for Post-Cesarean Acute Kidney Injury in Severe Preeclampsia: a Pilot Randomized Clinical Trial.,"OBJECTIVES


The aim of this study was to determine whether a restrictive compared to a liberal fluid therapy will increase postoperative acute kidney injury (AKI) in patients with severe preeclampsia.
METHODS


A total of 46 patients (mean age, 32 years; standard deviation, 6.8 years) with severe preeclampsia were randomized to liberal (1500 ml of lactated Ringer's, n=23) or restrictive (250 ml of lactated Ringer's, n=23) intravenous fluid regimen during cesarean section. The primary outcome was the development of a postoperative renal dysfunction defined by AKI Network stage ≥1. Serum cystatin C and neutrophil gelatinase-associated lipocalin (NGAL) were evaluated at postoperative days 1 and 2. ClinicalTrials.gov: NCT02214186.
RESULTS


The rate of postoperative AKI was 43.5% in the liberal fluid group and 43.5% in the restrictive fluid group (p=1.0). Intraoperative urine output was higher in the liberal (116 ml/h, IQR 69-191) than in the restrictive fluid group (80 ml/h, IQR 37-110, p<0.05). In both groups, serum cystatin C did not change from postoperative day 1 compared to the preoperative period and significantly decreased on postoperative day 2 compared to postoperative day 1 (p<0.05). In the restrictive fluid group, NGAL levels increased on postoperative day 1 compared to the preoperative period (p<0.05) and decreased on postoperative day 2 compared to postoperative day 1 (p<0.05).
CONCLUSION


Among patients with severe preeclampsia, a restrictive fluid regimen during cesarean section was not associated with increased postoperative AKI.",2020,"Intraoperative urine output was higher in the liberal (116 ml/h, IQR 69-191) than in the restrictive fluid group (80 ml/h, IQR 37-110, p<0.05).","['patients with severe preeclampsia', 'Post-Cesarean Acute Kidney Injury in Severe Preeclampsia', '46 patients (mean age, 32 years; standard deviation, 6.8 years) with severe preeclampsia']","[""liberal (1500 ml of lactated Ringer's, n=23) or restrictive (250 ml of lactated Ringer's, n=23) intravenous fluid regimen"", 'Restrictive versus Liberal Fluid Therapy', 'liberal fluid therapy']","['Serum cystatin C and neutrophil gelatinase-associated lipocalin (NGAL', 'Intraoperative urine output', 'NGAL levels', 'postoperative AKI', 'serum cystatin C', 'rate of postoperative AKI', 'development of a postoperative renal dysfunction defined by AKI Network stage ≥1', 'postoperative acute kidney injury (AKI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0341950', 'cui_str': 'Severe pre-eclampsia'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]","[{'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0073385', 'cui_str': ""Lactated Ringer's Solution""}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",46.0,0.206813,"Intraoperative urine output was higher in the liberal (116 ml/h, IQR 69-191) than in the restrictive fluid group (80 ml/h, IQR 37-110, p<0.05).","[{'ForeName': 'Wallace Andrino da', 'Initials': 'WAD', 'LastName': 'Silva', 'Affiliation': 'Departamento de Anestesia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Carlo Victor A', 'Initials': 'CVA', 'LastName': 'Varela', 'Affiliation': 'Departamento de Anestesia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Aline Macedo', 'Initials': 'AM', 'LastName': 'Pinheiro', 'Affiliation': 'Departamento de Anestesia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Paula Castro', 'Initials': 'PC', 'LastName': 'Scherer', 'Affiliation': 'Departamento de Anestesia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Rossana P V', 'Initials': 'RPV', 'LastName': 'Francisco', 'Affiliation': 'Departamento de Obstetricia e Ginecologia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Marcelo Luis Abramides', 'Initials': 'MLA', 'LastName': 'Torres', 'Affiliation': 'Departamento de Anestesia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Maria José C', 'Initials': 'MJC', 'LastName': 'Carmona', 'Affiliation': 'Departamento de Anestesia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Bliacheriene', 'Affiliation': 'Departamento de Anestesia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Lúcia C', 'Initials': 'LC', 'LastName': 'Andrade', 'Affiliation': 'Departamento de Nefrologia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pelosi', 'Affiliation': 'Dipartimento di Scienze Chirurgiche e Diagnostiche Integrate (DISC), Universitè degli Studi di Genova, Genoa, Italy.'}, {'ForeName': 'Luiz Marcelo S', 'Initials': 'LMS', 'LastName': 'Malbouisson', 'Affiliation': 'Departamento de Anestesia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}]","Clinics (Sao Paulo, Brazil)",['10.6061/clinics/2020/e1797']
1557,32693198,Short term effects of the REAL media e-learning media literacy substance prevention curriculum: An RCT of adolescents disseminated through a community organization.,"BACKGROUND


The primary aim of this study was to evaluate the short-term effects of testing an e-learning program to reduce adolescent substance use and abuse. Early initiation of substance use is linked to a variety of negative outcomes, thus effective intervention programs are needed. One approach is to use media literacy to capitalize on adolescents' immersion with media in a variety of forms. We developed, implemented, and tested an engaging substance use prevention program by collaborating with a youth-oriented community partner (4-H).
METHODS


639 middle adolescents from nine U.S. states participated in an RCT of REAL media. Participants completed a series of online surveys and were randomized to use an online substance prevention program (REAL media) or serve as control (delayed program use). Self-report surveys were administered at three points in time. This short-term evaluation uses data from the pretest (Time 1) and short-term posttest three-month surveys, which measured demographics, self-efficacy to counterargue, and injunctive and descriptive substance use norms.
RESULTS


Participants who completed the REAL media program reported increased self-efficacy to counterargue and decreased positive injunctive norms compared to control participants who did not complete the program. No significant differences were observed for descriptive norms.
CONCLUSIONS


We found support for the REAL media program in changing key predictors of youth substance use demonstrating (1) the efficacy of media literacy interventions targeting adolescents and (2) that e-learning substance use prevention efforts can be adapted for and implemented through community organizations.",2020,"RESULTS


Participants who completed the REAL media program reported increased self-efficacy to counterargue and decreased positive injunctive norms compared to control participants who did not complete the program.",['639 middle adolescents from nine U.S. states participated in an RCT of REAL media'],"['e-learning program', 'engaging substance use prevention program by collaborating with a youth-oriented community partner (4-H', 'REAL media e-learning media literacy substance prevention curriculum', 'online substance prevention program (REAL media) or serve as control (delayed program use']",['self-efficacy to counterargue and decreased positive injunctive norms'],"[{'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}]","[{'cui': 'C0086858', 'cui_str': 'Programmed Learning'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0150358', 'cui_str': 'Substance use prevention'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}]",639.0,0.0245006,"RESULTS


Participants who completed the REAL media program reported increased self-efficacy to counterargue and decreased positive injunctive norms compared to control participants who did not complete the program.","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Greene', 'Affiliation': 'Department of Communication, Rutgers, the State University of New Jersey, 4 Huntington St., New Brunswick, NJ, 08901, USA. Electronic address: klgreene@rutgers.edu.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Ray', 'Affiliation': 'Department of Health, Behavior & Society, University of Kentucky, 343 Bowman Hall, Lexington, KY, 40536, USA.'}, {'ForeName': 'Hye Jeong', 'Initials': 'HJ', 'LastName': 'Choi', 'Affiliation': 'Department of Health Sciences, University of Missouri, 501 Clark Hall, Columbia, MO, 65211, USA.'}, {'ForeName': 'Shannon D', 'Initials': 'SD', 'LastName': 'Glenn', 'Affiliation': 'Department of Communication, Rutgers, the State University of New Jersey, 4 Huntington St., New Brunswick, NJ, 08901, USA; REAL Prevention, LLC, 130 Pearl Brook Drive, Clifton, NJ, 07013, USA.'}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Lyons', 'Affiliation': 'Department of 4-H Youth Development, Rutgers, the State University of New Jersey, 88 Lipman Drive, New Brunswick, NJ, 08901, USA.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Hecht', 'Affiliation': 'REAL Prevention, LLC, 130 Pearl Brook Drive, Clifton, NJ, 07013, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108170']
1558,32693214,Biomarkers of Type 2 Airway Inflammation as Predictors of Loss of Asthma Control During Step-Down Therapy for Well-Controlled Disease: The Long-Acting Beta-Agonist Step-Down Study (LASST).,"BACKGROUND


Biomarkers that can predict loss of asthma control among patients being considered for step-down therapy in well-controlled disease are lacking.
OBJECTIVE


To evaluate whether baseline biomarkers of type 2 airway inflammation and/or serial measurement of fractional exhaled nitric oxide (Feno) predict loss of asthma control as therapy is stepped down.
METHODS


In subanalyses of a multicenter randomized, double-blind, parallel 3-arm trial comparing strategies for step-down therapy in well-controlled asthma (Long-Acting Beta-Agonist Step-Down Study), we assessed whether baseline atopy as determined by serum aeroallergen allergy screening test (Phadiatop), baseline serum eosinophil peroxidase, or baseline or serial Feno measurements during follow-up predicted the time to loss of asthma control among participants. Loss of asthma control was defined in the study protocol. We analyzed these associations in adjusted models including all participants, after testing for interactions with assignment to each of the 3 treatment groups (continuation of stable dose of combination inhaled corticosteroid-long-acting beta-agonist, step-down of inhaled corticosteroid, or discontinuation of long-acting bronchodilator).
RESULTS


Four hundred forty-seven of the 553 Long-Acting Beta-Agonist Step-Down Study participants who were randomized to 1 of 3 treatment arms and had at least 1 biomarker measurement were included in this analysis. At baseline, higher levels of Feno were significantly associated with greater levels of multiallergen IgE levels (P < .001), but not with serum eosinophil peroxidase (P = .742). Among all participants as a group, elevations in baseline biomarkers were not predictive of a higher risk of treatment failure. In addition, Feno levels measured serially at 6-week intervals demonstrated that compared with participants with low levels (<25 parts per billion), those with intermediate (25-50 parts per billion) and high (>50 parts per billion) levels did not have significantly increased likelihood of subsequent treatment failure (hazard ratios, 1.03 [95% CI, 0.59-1.78] and 1.29 [95% CI, 0.65-2.54], respectively). There were no significant interactions of treatment group and baseline biomarkers.
CONCLUSIONS


In patients with well-controlled asthma, neither baseline levels of type 2 airway inflammatory biomarkers nor serial measures of Feno are strong predictors of treatment failure.",2020,"In patients with well-controlled asthma, neither baseline levels of type 2 airway inflammatory biomarkers nor serial measures of FeNO are strong predictors of treatment failure.",['Four hundred and forty-seven of the 553 LASST participants who were randomized to one of 3 treatment arms and had at least one biomarker measurement were included in this analysis'],"['combination ICS-LABA, step-down of inhaled corticosteroid (ICS), or discontinuation of long acting bronchodilator (LABA']","['levels of FeNO', 'likelihood of subsequent treatment failure', 'FeNO levels', 'levels of multi-allergen IgE levels', 'serum aeroallergen allergy screening test (Phadiatop), baseline serum eosinophil peroxidase (EpX), or baseline or serial FeNO measurements', 'Loss of asthma control']","[{'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001697', 'cui_str': 'Aeroallergen'}, {'cui': 'C1273434', 'cui_str': 'Allergy screening test'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",553.0,0.395791,"In patients with well-controlled asthma, neither baseline levels of type 2 airway inflammatory biomarkers nor serial measures of FeNO are strong predictors of treatment failure.","[{'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Bose', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY; Johns Hopkins School of Medicine, Baltimore, Md.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bime', 'Affiliation': 'University of Arizona College of Medicine, Tucson, Ariz.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Henderson', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, Md.'}, {'ForeName': 'Kathryn V', 'Initials': 'KV', 'LastName': 'Blake', 'Affiliation': ""Nemours Children's Health System, Jacksonville, Fla.""}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Washington University School of Medicine, St Louis, Mo.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'DiMango', 'Affiliation': 'Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Nicola A', 'Initials': 'NA', 'LastName': 'Hanania', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Janet T', 'Initials': 'JT', 'LastName': 'Holbrook', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, Md.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Irvin', 'Affiliation': 'University of Vermont, Burlington, Vt.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Kraft', 'Affiliation': 'University of Arizona College of Medicine, Tucson, Ariz.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Peters', 'Affiliation': 'Wake Forest University School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Reibman', 'Affiliation': 'New York University School of Medicine, New York, NY.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Sugar', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Md.'}, {'ForeName': 'Kaharu', 'Initials': 'K', 'LastName': 'Sumino', 'Affiliation': 'Washington University School of Medicine, St Louis, Mo.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, Md.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Rogers', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: linda.rogers@mssm.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.06.067']
1559,32693322,"Effects of messaging on public support for drug consumption rooms in scotland, UK.","BACKGROUND


There is evidence to suggest that medically supervised drug consumption rooms (DCRs) may form part of responses to reduce drug-related harm. Although DCRs have been established globally, they are perceived by some to be a controversial approach in the UK, and Government has repeatedly rejected proposals to establish one in Glasgow, Scotland. As public support is an important component of policy development and enactment, we sought to investigate the effects of different types of message framing on public support for DCR.
METHODS


We undertook a cross-sectional online study with a randomised design, conducted with a nationally representative sample. Participants were randomised to one of six message conditions comprising combinations of four components. All conditions included i) a basic description of a DCR, and conditions included combinations of ii) factual information; iii) pre-emptive refutation of common public concerns about DCR; and/or iv) a sympathetic narrative describing a mother whose son died from a heroin overdose. After reading each message, participants completed a bespoke measure assessing support for DCR. Data were analysed using ANCOVA.
RESULTS


Complete data were obtained from 1591 participants (50.3% Female; mean age 44.9 ± 16.1 years). Compared to reading a basic description of DCR alone, there was greater support for DCR in participants receiving the refutation (p < .001); sympathetic + factual (p < .05); and sympathetic + factual + refutation (p < .001) message conditions. Presenting factual or sympathetic messages alone were not associated with increased support.
CONCLUSION


Our findings suggest that public support for DCRs is not improved through communication of factual statements outlining potential benefits of the intervention alone. Advocates seeking to foster public support, and thus influence policy making, should also consider communication campaigns that address common concerns that the public might have about DCRs, and present the intervention in relation to potential benefits that they hold for people indirectly affected by drug-related harm.",2020,"Compared to reading a basic description of DCR alone, there was greater support for DCR in participants receiving the refutation (p < .001);",['1591 participants (50.3% Female; mean age 44.9\xa0±\xa016.1 years'],[],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319689', 'cui_str': '16.1'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],[],1591.0,0.119354,"Compared to reading a basic description of DCR alone, there was greater support for DCR in participants receiving the refutation (p < .001);","[{'ForeName': 'H R', 'Initials': 'HR', 'LastName': 'Sumnall', 'Affiliation': 'Public Health Institute, Liverpool John Moores University, Liverpool, UK. Electronic address: h.sumnall@ljmu.ac.uk.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Atkinson', 'Affiliation': 'Public Health Institute, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'K M A', 'Initials': 'KMA', 'LastName': 'Trayner', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK; Health Protection Scotland, Glasgow, UK.'}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Gage', 'Affiliation': 'Psychological Sciences, University of Liverpool, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'McAuley', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK; Health Protection Scotland, Glasgow, UK.'}]",The International journal on drug policy,['10.1016/j.drugpo.2020.102855']
1560,32700585,"Severe, transient pulmonary ventilation-perfusion mismatch in the lung after porcine high velocity projectile behind armor blunt trauma.","BACKGROUND


Behind armor blunt trauma (BABT) is a non-penetrating injury caused by the rapid deformation of body armor, by a projectile, which may in extreme circumstances cause death. Although there is not a high incidence of high energy BABT, the understanding of the mechanisms is still low, in relation to what is needed for safety threshold levels. BABT is also useful as a model for blunt thoracic trauma, with a compressive speed between traffic accidents and blast caused by explosives. High velocity projectile BABT causes severe hypoxia. The mechanisms are not fully known. We investigated the acute pulmonary consequences in the individual lungs, and the effects of alveolar recruitment.
METHODS


12 swine (mean weight 62.5 kg) were randomized to groups BABT by 7.62 × 51 mm NATO-type bullets (mean velocity 803 m/s) to a military grade ceramic plate armor (n = 7) or control (n = 5). Modified double lumen tracheal tubes provided respiratory dynamics in the lungs separately/intermittently for two hours, with alveolar recruitment after one hour.
RESULTS


Venous admixture increased 5 min after BABT (p < .05) and correlated with increased cardiac output. Static compliance decreased 5 minutes after BABT (p < .05) and further by recruitment (p < .005). Physiological dead space decreased 5 minutes after BABT (p < .01) and further by recruitment (p < .01), while not in the contralateral lung. V'A/Q' decreased 5 minutes after BABT (p < .05), also shown in phase III volumetric capnography (p < .05). Most effects regressed after one hour.
CONCLUSIONS


High velocity projectile BABT caused hypoxia by a severe and transient decrease in V'A/Q' to <1 and increased venous admixture in the exposed lung. Alveolar recruitment was hemodynamically and respiratory tolerable and increased V'A/Q'. Body armor development should aim at ameliorating severe pulmonary consequences from high projectile velocities which also needs to include further understanding of how primary and secondary effects are distributed between the lungs.",2020,"RESULTS


Venous admixture increased 5 min after BABT (p < .05) and correlated with increased cardiac output.","['12 swine ', 'mean weight 62.5\u2009kg']","['military grade ceramic plate armor (n\u2009=\u20097) or control', 'BABT']","['cardiac output', 'Venous admixture increased 5\u2009min after BABT', ""Alveolar recruitment was hemodynamically and respiratory tolerable and increased V'A/Q"", 'Physiological dead space', ""V'A/Q"", 'Static compliance']","[{'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4517836', 'cui_str': '62.5'}]","[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043253', 'cui_str': 'Blunt injury'}]","[{'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0043253', 'cui_str': 'Blunt injury'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0231936', 'cui_str': 'Normal ventilation-perfusion ratio'}, {'cui': 'C0231975', 'cui_str': 'Physiological dead space'}, {'cui': 'C0429681', 'cui_str': 'Static lung compliance'}]",,0.039932,"RESULTS


Venous admixture increased 5 min after BABT (p < .05) and correlated with increased cardiac output.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rocksén', 'Affiliation': 'Department of Neuroscience, section of Experimental Traumatology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ulf P', 'Initials': 'UP', 'LastName': 'Arborelius', 'Affiliation': 'Department of Neuroscience, section of Experimental Traumatology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gustavsson', 'Affiliation': 'Department of Neuroscience, section of Experimental Traumatology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Günther', 'Affiliation': 'Department of Clinical Science and Education, Section of Anesthesiology and Intensive Care, Karolinska Institutet, Stockholm, Sweden.'}]",Experimental lung research,['10.1080/01902148.2020.1797246']
1561,32706953,Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19.,"BACKGROUND


Hydroxychloroquine and azithromycin have been used to treat patients with coronavirus disease 2019 (Covid-19). However, evidence on the safety and efficacy of these therapies is limited.
METHODS


We conducted a multicenter, randomized, open-label, three-group, controlled trial involving hospitalized patients with suspected or confirmed Covid-19 who were receiving either no supplemental oxygen or a maximum of 4 liters per minute of supplemental oxygen. Patients were randomly assigned in a 1:1:1 ratio to receive standard care, standard care plus hydroxychloroquine at a dose of 400 mg twice daily, or standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days. The primary outcome was clinical status at 15 days as assessed with the use of a seven-level ordinal scale (with levels ranging from one to seven and higher scores indicating a worse condition) in the modified intention-to-treat population (patients with a confirmed diagnosis of Covid-19). Safety was also assessed.
RESULTS


A total of 667 patients underwent randomization; 504 patients had confirmed Covid-19 and were included in the modified intention-to-treat analysis. As compared with standard care, the proportional odds of having a higher score on the seven-point ordinal scale at 15 days was not affected by either hydroxychloroquine alone (odds ratio, 1.21; 95% confidence interval [CI], 0.69 to 2.11; P = 1.00) or hydroxychloroquine plus azithromycin (odds ratio, 0.99; 95% CI, 0.57 to 1.73; P = 1.00). Prolongation of the corrected QT interval and elevation of liver-enzyme levels were more frequent in patients receiving hydroxychloroquine, alone or with azithromycin, than in those who were not receiving either agent.
CONCLUSIONS


Among patients hospitalized with mild-to-moderate Covid-19, the use of hydroxychloroquine, alone or with azithromycin, did not improve clinical status at 15 days as compared with standard care. (Funded by the Coalition Covid-19 Brazil and EMS Pharma; ClinicalTrials.gov number, NCT04322123.).",2020,"Prolongation of the corrected QT interval and elevation of liver-enzyme levels were more frequent in patients receiving hydroxychloroquine, alone or with azithromycin, than in those who were not receiving either agent.
","['hospitalized patients with suspected or confirmed Covid-19 who were receiving either no supplemental oxygen or a maximum of 4 liters per minute of supplemental oxygen', 'Mild-to-Moderate Covid-19', 'patients with coronavirus disease 2019 (Covid-19', 'patients hospitalized with mild-to-moderate Covid-19', '667 patients underwent randomization; 504 patients had confirmed Covid-19 and were included in the modified intention-to-treat analysis']","['Hydroxychloroquine and azithromycin', 'hydroxychloroquine', 'hydroxychloroquine plus azithromycin', 'Hydroxychloroquine with or without Azithromycin', 'azithromycin', 'standard care, standard care plus hydroxychloroquine at a dose of 400 mg twice daily, or standard care plus hydroxychloroquine']","['safety and efficacy', 'Safety', 'Prolongation of the corrected QT interval and elevation of liver-enzyme levels', 'clinical status at 15 days as assessed with the use of a seven-level ordinal scale']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C4517851', 'cui_str': '667'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0428321', 'cui_str': 'Measurement of liver enzyme'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",667.0,0.251782,"Prolongation of the corrected QT interval and elevation of liver-enzyme levels were more frequent in patients receiving hydroxychloroquine, alone or with azithromycin, than in those who were not receiving either agent.
","[{'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Zampieri', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Regis G', 'Initials': 'RG', 'LastName': 'Rosa', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Luciano C P', 'Initials': 'LCP', 'LastName': 'Azevedo', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Viviane C', 'Initials': 'VC', 'LastName': 'Veiga', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Avezum', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Lucas P', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Marcadenti', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Letícia', 'Initials': 'L', 'LastName': 'Kawano-Dourado', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Lisboa', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Debora L M', 'Initials': 'DLM', 'LastName': 'Junqueira', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Pedro G M', 'Initials': 'PGM', 'LastName': 'de Barros E Silva', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Tramujas', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Erlon O', 'Initials': 'EO', 'LastName': 'Abreu-Silva', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Ligia N', 'Initials': 'LN', 'LastName': 'Laranjeira', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Aline T', 'Initials': 'AT', 'LastName': 'Soares', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Leandro S', 'Initials': 'LS', 'LastName': 'Echenique', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Adriano J', 'Initials': 'AJ', 'LastName': 'Pereira', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Flávio G R', 'Initials': 'FGR', 'LastName': 'Freitas', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Otávio C E', 'Initials': 'OCE', 'LastName': 'Gebara', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Vicente C S', 'Initials': 'VCS', 'LastName': 'Dantas', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Remo H M', 'Initials': 'RHM', 'LastName': 'Furtado', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Eveline P', 'Initials': 'EP', 'LastName': 'Milan', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Golin', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Fábio F', 'Initials': 'FF', 'LastName': 'Cardoso', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Israel S', 'Initials': 'IS', 'LastName': 'Maia', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Conrado R', 'Initials': 'CR', 'LastName': 'Hoffmann Filho', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Adrian P M', 'Initials': 'APM', 'LastName': 'Kormann', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Roberto B', 'Initials': 'RB', 'LastName': 'Amazonas', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Monalisa F', 'Initials': 'MF', 'LastName': 'Bocchi de Oliveira', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Ary', 'Initials': 'A', 'LastName': 'Serpa-Neto', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Maicon', 'Initials': 'M', 'LastName': 'Falavigna', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Flávia R', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2019014']
1562,32722955,"Ranibizumab versus aflibercept for diabetic macular edema: 18-month results of a comparative, prospective, randomized study and multivariate analysis of visual outcome predictors.","PURPOSE


The purpose of this study was to compare the anatomical and functional outcomes of ranibizumab versus aflibercept for the treatment of diabetic macular edema (DME) in a long-term follow-up.
METHODS


Participants in this prospective study were 112 treatment naïve patients with DME, who received treatment with either intravitreal ranibizumab (n = 54) or aflibercept (n = 58). The demographic data, the best-corrected visual acuity (BCVA) and spectral-domain optical coherence tomography (SD-OCT) characteristics were evaluated at baseline and at month 1, 2, 3, 6, 12, and 18 post treatment, while factors affecting visual outcome were determined using multivariate analysis.
RESULTS


At month 18, the mean BCVA of ranibizumab-treated eyes increased 7.9 letters compared to 6.9 letters for eyes receiving aflibercept, with greater number of injections in ranibizumab group (9.2 ± 2.3 vs. 7.6 ± 2.1 injections in the ranibizumab and aflibercept group respectively,  p  = 0.0002). The difference in letters between the two groups was not statistically significant, nor the difference in central subfield thickness at month 18. Factors associated with poorer BCVA were found to be increasing age, HbA1c ≥7.5%, increasing central retinal thickness and disrupted ellipsoid zone.
CONCLUSIONS


Ranibizumab and aflibercept presented similar anatomical and functional outcomes in 18-month follow-up in patients with DME. It is important to determine factors, affecting VA, so as to provide individualized treatment.",2020,"The difference in letters between the two groups was not statistically significant, nor the difference in central subfield thickness at month 18.","['were 112 treatment naïve patients with DME', 'diabetic macular edema (DME', 'patients with DME', 'diabetic macular edema']","['aflibercept', 'ranibizumab and aflibercept', 'Ranibizumab', 'ranibizumab versus aflibercept', 'intravitreal ranibizumab', 'Ranibizumab and aflibercept', 'ranibizumab']","['mean BCVA', 'spectral-domain optical coherence tomography (SD-OCT) characteristics', 'central subfield thickness', 'central retinal thickness']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0058217', 'cui_str': 'dimethyl ether'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}]",112.0,0.0525292,"The difference in letters between the two groups was not statistically significant, nor the difference in central subfield thickness at month 18.","[{'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Chatzirallis', 'Affiliation': '2nd Department of Ophthalmology, Ophthalmiatrion Athinon, Athens, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Theodossiadis', 'Affiliation': '2nd Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Droutsas', 'Affiliation': '1st Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Chryssanthi', 'Initials': 'C', 'LastName': 'Koutsandrea', 'Affiliation': '1st Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Ladas', 'Affiliation': '1st Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Marilita M', 'Initials': 'MM', 'LastName': 'Moschos', 'Affiliation': '1st Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece.'}]",Cutaneous and ocular toxicology,['10.1080/15569527.2020.1802741']
1563,32611638,Minimal manifestation status and prednisone withdrawal in the MGTX trial.,"OBJECTIVE


To examine whether sustained minimal manifestation status (MMS) with complete withdrawal of prednisone is better achieved in thymectomized patients with myasthenia gravis (MG).
METHODS


This study is a post hoc analysis of data from a randomized trial of thymectomy in MG (Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy [MGTX]). MGTX was a multicenter, randomized, rater-blinded 3-year trial that was followed by a voluntary 2-year extension for patients with acetylcholine receptor (AChR) antibody-positive MG without thymoma. Patients were randomized 1:1 to thymectomy plus prednisone vs prednisone alone. Participants were age 18-65 years at enrollment with disease duration less than 5 years. All patients received oral prednisone titrated up to 100 mg on alternate days until they achieved MMS, which prompted a standardized prednisone taper as long as MMS was maintained. The achievement rate of sustained MMS (no symptoms of MG for 6 months) with complete withdrawal of prednisone was compared between the thymectomy plus prednisone and prednisone alone groups.
RESULTS


Patients with MG in the thymectomy plus prednisone group achieved sustained MMS with complete withdrawal of prednisone more frequently (64% vs 38%) and quickly compared to the prednisone alone group (median time 30 months vs no median time achieved,  p  < 0.001) over the 5-year study period. Prednisone-associated adverse symptoms were more frequent in the prednisone alone group and distress level increased with higher doses of prednisone.
CONCLUSIONS


Thymectomy benefits patients with MG by increasing the likelihood of achieving sustained MMS with complete withdrawal of prednisone.
CLINICALTRIALSGOV IDENTIFIER


NCT00294658.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that for patients with generalized MG with AChR antibody, those receiving thymectomy plus prednisone are more likely to attain sustained MMS and complete prednisone withdrawal than those on prednisone alone.",2020,"Prednisone associated adverse symptoms were more frequent in the prednisone alone group and distress level increased with higher doses of prednisone.
","['generalized MG patients with AChR antibody, those receiving', 'thymectomized myasthenia gravis (MG) patients', 'patients with acetylcholine receptor (AChR) antibody positive MG without thymoma', 'Participants were age 18-65 years at enrollment with disease duration less than 5 years', 'myasthenia gravis (MGTX']","['prednisone', 'thymectomy plus prednisone', 'Prednisone', 'MGTX', 'thymectomy', 'oral prednisone', 'thymectomy plus prednisone versus prednisone alone']","['achievement rate of sustained MMS', 'distress level', 'sustained MMS', 'adverse symptoms']","[{'cui': 'C0472367', 'cui_str': 'Generalized myasthenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0236516', 'cui_str': 'Acetylcholine receptor antibody'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}, {'cui': 'C0034792', 'cui_str': 'Cholinergic receptor'}, {'cui': 'C0741132', 'cui_str': 'Antibody test positive'}, {'cui': 'C0040100', 'cui_str': 'Thymoma'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0174725', 'cui_str': 'margatoxin'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0040071', 'cui_str': 'Excision of thymus'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0174725', 'cui_str': 'margatoxin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.173208,"Prednisone associated adverse symptoms were more frequent in the prednisone alone group and distress level increased with higher doses of prednisone.
","[{'ForeName': 'Ikjae', 'Initials': 'I', 'LastName': 'Lee', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY. leeij15@gmail.com.'}, {'ForeName': 'Hui-Chien', 'Initials': 'HC', 'LastName': 'Kuo', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Inmaculada B', 'Initials': 'IB', 'LastName': 'Aban', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Cutter', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Tarrant', 'Initials': 'T', 'LastName': 'McPherson', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Kaminski', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Sussman', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Ströbel', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Oger', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Cea', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Jeannine M', 'Initials': 'JM', 'LastName': 'Heckmann', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Evoli', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Wilfred', 'Initials': 'W', 'LastName': 'Nix', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Ciafaloni', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Antonini', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Rawiphan', 'Initials': 'R', 'LastName': 'Witoonpanich', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'John O', 'Initials': 'JO', 'LastName': 'King', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Said R', 'Initials': 'SR', 'LastName': 'Beydoun', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Colin H', 'Initials': 'CH', 'LastName': 'Chalk', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Alexandru C', 'Initials': 'AC', 'LastName': 'Barboi', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Amato', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Aziz I', 'Initials': 'AI', 'LastName': 'Shaibani', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Bashar', 'Initials': 'B', 'LastName': 'Katirji', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Bryan R F', 'Initials': 'BRF', 'LastName': 'Lecky', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Buckley', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Vincent', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Elza', 'Initials': 'E', 'LastName': 'Dias-Tosta', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Yoshikawa', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Waddington-Cruz', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Pulley', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Rivner', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kostera-Pruszczyk', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Pascuzzi', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Carlayne E', 'Initials': 'CE', 'LastName': 'Jackson', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Jan J G', 'Initials': 'JJG', 'LastName': 'Verschuuren', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Janice M', 'Initials': 'JM', 'LastName': 'Massey', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Kissel', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Lineu C', 'Initials': 'LC', 'LastName': 'Werneck', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Benatar', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Barohn', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Rup', 'Initials': 'R', 'LastName': 'Tandan', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Tahseen', 'Initials': 'T', 'LastName': 'Mozaffar', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Conwit', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Minisman', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Sonett', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': 'Gil I', 'Initials': 'GI', 'LastName': 'Wolfe', 'Affiliation': 'From the Departments of Neurology (I.L.) and Biostatistics (H.-C.K., I.B.A., G.R.C., T.M., G.M.), University of Alabama at Birmingham; Department of Neurology (H.J.K.), George Washington University School of Medicine and Health Sciences, Washington, DC; Department of Neurology (J.S.), Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK; Institute of Pathology (P.S.), University Medical Center Göttingen; Division of Neurology (J.O.), University of British Columbia, Vancouver, Canada; Department of Neurology (G.C.), University of Chile, Santiago; Division of Neurology (J.M.H.), Department of Medicine, University of Cape Town, South Africa; Department of Neurology (A.E.), Catholic University, Rome, Italy; Department of Neurology (W.N.), Johannes Gutenberg University, Mainz, Germany; Department of Neurology (E.C.), University of Rochester Medical Center, NY; Department of Neurosciences (G.A.), Mental Health and Sensory Organs, Sapienza University of Rome, Italy; Division of Neurology (R.W.), Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Department of Neurology (J.O.K.), Royal Melbourne Hospital, Victoria, Australia; Department of Neurology (S.R.B.), University of Southern California, Los Angeles; Department of Neurology (C.H.C.), McGill University, Montreal, Canada; Department of Neurology (A.C.B.), Medical College of Wisconsin, Milwaukee; Department of Neurology (A.A.A.), Harvard Medical School, Boston, MA; Nerve and Muscle Center of Texas (A.I.S.), Houston; Department of Neurology (B.K.), Case Western Reserve University, Cleveland, OH; Walton Centre for Neurology and Neurosurgery (B.R.F.L.), Liverpool; Nuffield Department of Clinical Neurosciences (C.B., A.V.), Oxford University, UK; Unit of Neurology (E.D.-T.), University of Brasilia, Brazil; Department of Neurology (H.Y.), Kanazawa University, Japan; Department of Neurology (M.W.-C.), Federal University, Rio de Janeiro, Brazil; Department of Neurology (M.T.P.), University of Florida, Jacksonville; Department of Neurology (M.H.R.), Augusta University, GA; Department of Neurology (A.K.-P.), Medical University of Warsaw, Poland; Department of Neurology (R.M.P.), Indiana School of Medicine, Indianapolis; Department of Neurology (C.E.J.), University of Texas Health Science Center, San Antonio; Department of Neurology (J.J.G.V.), Leiden University Medical Center, the Netherlands; Department of Neurology (J.M.M.), Duke University Medical Center, Durham, NC; Department of Neurology (J.T.K.), Ohio State University Wexner Medical Center, Columbus; Department of Neurology (L.C.W.), Universidade Federal do Parana, Curitiba, Brazil; Department of Neurology (M.B.), University of Miami, FL; Department of Neurology (R.J.B.), University of Kansas Medical Center, Kansas City; Department of Neurological Sciences (R.T.), University of Vermont College of Medicine, Burlington; Department of Neurology (T.M.), University of California Irvine Medical Center, Orange; Division of Extramural Research (R.C.), NIH, National Institute of Neurological Disorders and Stroke, Bethesda, MD; Section of General Thoracic Surgery (J.R.S.), Columbia University Medical Center, New York; and Department of Neurology (G.I.W.), University at Buffalo Jacobs School of Medicine and Biomedical Sciences, NY.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000010031']
1564,32702522,Impact of couple conflict and mediation on how romantic partners are seen: An fMRI study.,"Previous studies on romantic love have reported increased neural activity in the brain's reward circuitry such as the striatum. To date, the extent to which this activity is modulated by couple conflict in general and mediated couple conflict in particular, is unknown. The present study seeks to fill this gap by randomly assigning 36 romantic heterosexual couples to a mediated or non-mediated conflict discussion. Before and after the conflict discussion, self-reports and functional neuroimaging data in response to a picture of the romantic partner versus an unknown person were acquired. Self-reports indicate that mediation increases conflict resolution, satisfaction about the contents and process of the discussion and decreases levels of remaining disagreement. Pre-conflict neuroimaging results replicate previous studies on romantic love, showing activations in the striatum, insula, anterior and posterior cingulate gyrus, orbitofrontal cortex, hippocampus, temporal and occipital poles and amygdala when viewing the romantic partner versus an unknown person. The general effect of conflict on neural activations in response to the romantic partner across both conditions consisted of deactivations in the striatum, insula, thalamus, precuneus and ventral tegmental area. Small volume correction analyses revealed that participants in the mediated condition trended towards having greater activation in the nucleus accumbens than participants in the non-mediated condition when looking at the romantic partner versus the unknown after the conflict discussion. Parametric modulation analyses also revealed greater activity in the nucleus accumbens when viewing the romantic partner versus the unknown for participants who felt more satisfied after the conflict resolution. Our results illustrate that mediation improves conflict resolution and is associated with increased activity in the nucleus accumbens, a key region in the brain's reward circuitry.",2020,Parametric modulation analyses also revealed greater activity in the nucleus accumbens when viewing the romantic partner versus the unknown for participants who felt more satisfied after the conflict resolution.,['36 romantic heterosexual couples to a mediated or non-mediated conflict discussion'],[],"['neural activity', 'conflict resolution']","[{'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}]",[],"[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0150526', 'cui_str': 'Conflict Resolution'}]",36.0,0.0299096,Parametric modulation analyses also revealed greater activity in the nucleus accumbens when viewing the romantic partner versus the unknown for participants who felt more satisfied after the conflict resolution.,"[{'ForeName': 'Halima', 'Initials': 'H', 'LastName': 'Rafi', 'Affiliation': 'Swiss Center for Affective Sciences, University of Geneva, Geneva, Switzerland; Department of Psychology, University of Geneva, Geneva, Switzerland. Electronic address: Halima.Rafi@unige.ch.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Bogacz', 'Affiliation': 'Swiss Center for Affective Sciences, University of Geneva, Geneva, Switzerland; Computer Vision and Multimedia Laboratory, University of Geneva, Battelle Campus, Carouge, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sander', 'Affiliation': 'Swiss Center for Affective Sciences, University of Geneva, Geneva, Switzerland; Laboratory for the Study of Emotion Elicitation and Expression, Department of Psychology, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Klimecki', 'Affiliation': 'Swiss Center for Affective Sciences, University of Geneva, Geneva, Switzerland; Laboratory for the Study of Emotion Elicitation and Expression, Department of Psychology, University of Geneva, Geneva, Switzerland; Laboratory for Behavioral Neurology and Imaging of Cognition, Department of Neuroscience, Medical School, University of Geneva, Geneva, Switzerland. Electronic address: Olga.Klimecki@unige.ch.'}]",Cortex; a journal devoted to the study of the nervous system and behavior,['10.1016/j.cortex.2020.04.036']
1565,32703808,"When possible, report a Fisher-exact  P  value and display its underlying null randomization distribution.","In randomized experiments, Fisher-exact  P  values are available and should be used to help evaluate results rather than the more commonly reported asymptotic  P  values. One reason is that using the latter can effectively alter the question being addressed by including irrelevant distributional assumptions. The Fisherian statistical framework, proposed in 1925, calculates a  P  value in a randomized experiment by using the actual randomization procedure that led to the observed data. Here, we illustrate this Fisherian framework in a crossover randomized experiment. First, we consider the first period of the experiment and analyze its data as a completely randomized experiment, ignoring the second period; then, we consider both periods. For each analysis, we focus on 10 outcomes that illustrate important differences between the asymptotic and Fisher tests for the null hypothesis of no ozone effect. For some outcomes, the traditional  P  value based on the approximating asymptotic Student's  t  distribution substantially subceeded the minimum attainable Fisher-exact  P  value. For the other outcomes, the Fisher-exact null randomization distribution substantially differed from the bell-shaped one assumed by the asymptotic  t  test. Our conclusions: When researchers choose to report  P  values in randomized experiments, 1) Fisher-exact  P  values should be used, especially in studies with small sample sizes, and 2) the shape of the actual null randomization distribution should be examined for the recondite scientific insights it may reveal.",2020,"For some outcomes, the traditional  P  value based on the approximating asymptotic Student's  t  distribution substantially subceeded the minimum attainable Fisher-exact  P  value.",[],[],[],[],[],[],,0.0315853,"For some outcomes, the traditional  P  value based on the approximating asymptotic Student's  t  distribution substantially subceeded the minimum attainable Fisher-exact  P  value.","[{'ForeName': 'M-A C', 'Initials': 'MC', 'LastName': 'Bind', 'Affiliation': 'Department of Statistics, Faculty of Arts and Sciences, Harvard University, Cambridge, MA 02138; ma.bind@mail.harvard.edu.'}, {'ForeName': 'D B', 'Initials': 'DB', 'LastName': 'Rubin', 'Affiliation': 'Yau Center for Mathematical Sciences, Tsinghua University, Beijing 100084, China.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1915454117']
1566,32705941,Use of chest X-ray in the assessment of community acquired pneumonia in primary care - an intervention study.,"OBJECTIVES


The aim of this study was to explore if consequent use of chest X-ray (CXR), when the physician is not sure of the diagnosis of pneumonia after clinical examination and CRP-testing, favors a more restrictive prescribing of antibiotics.
DESIGN


This was an intervention study conducted between September 2015 and December 2017.
SETTING


Two intervention primary health care centers (PHCCs) and three control PHCCs in the southeast of Sweden.
INTERVENTION


All patients were referred for CXR when the physician´s suspicion of pneumonia was 'unsure', or 'quite sure' after CRP-testing. Control units managed patients according to their usual routine after clinical examination and CRP-testing.
SUBJECTS


A total of 104 patients were included in the intervention group and 81 patients in the control group. The inclusion criteria of the study were clinically suspected pneumonia in patients ≥18 years, with respiratory symptoms for more than 24 h.  Main outcome measure:  Antibiotic prescribing rate.
RESULTS


In the intervention group, 85% were referred for CXR and 69% were prescribed antibiotics, as compared to 26% and 77% in the control group. The difference in antibiotic prescribing rate was not statistically significant, unadjusted OR 0.68 [0.35-1.3] and adjusted OR 1.1 [CI 0.43-3.0]. A total of 24% of patients with negative CXR were prescribed antibiotics.
CONCLUSION


This study could not prove that use of CXR when the physician was not sure of the diagnosis of pneumonia results in lowered antibiotic prescribing rate in primary care. In cases of negative findings on CXR the physicians do not seem to rely on the outcome when it comes to antibiotic prescribing. Key Points Routine use of chest X-ray when the clinical diagnosis of pneumonia is uncertain has not been proven to result in lowered antibiotic prescribing rate. Physicians do not fully rely on chest X-ray outcome and to some extent prescribe antibiotics even if negative, when community-acquired pneumonia is suspected. Chest X-ray is already used in one out of four cases in routine primary care of pneumonia patients in Sweden.",2020,"The difference in antibiotic prescribing rate was not statistically significant, unadjusted OR 0.68 [0.35-1.3] and adjusted OR 1.1 [CI 0.43-3.0].","['pneumonia patients in Sweden', 'Two intervention primary health care centers (PHCCs) and three control PHCCs in the southeast of Sweden', 'patients ≥18 years, with respiratory symptoms for more than 24\u2009h.  Main outcome measure:  Antibiotic prescribing rate', 'September 2015 and December 2017', 'Control units managed patients according to their usual routine after clinical examination and CRP-testing', '104 patients were included in the intervention group and 81 patients in the control group']","['chest X-ray', 'chest X-ray (CXR']",['antibiotic prescribing rate'],"[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C3873701', 'cui_str': 'Control unit'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}]",104.0,0.026647,"The difference in antibiotic prescribing rate was not statistically significant, unadjusted OR 0.68 [0.35-1.3] and adjusted OR 1.1 [CI 0.43-3.0].","[{'ForeName': 'Anna B', 'Initials': 'AB', 'LastName': 'Moberg', 'Affiliation': 'Kärna Primary Healthcare Centre, Linköping, Sweden.'}, {'ForeName': 'Moa', 'Initials': 'M', 'LastName': 'Kling', 'Affiliation': 'Kungsgatan Primary Healthcare Centre, Linköping, Sweden.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Paues', 'Affiliation': 'Department of Health, Medicine and Caring Sciences and Department of Radiological Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Sven Göran', 'Initials': 'SG', 'LastName': 'Fransson', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, General Practice, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Falk', 'Affiliation': 'Kärna Primary Healthcare Centre, Linköping, Sweden.'}]",Scandinavian journal of primary health care,['10.1080/02813432.2020.1794404']
1567,32708456,Long-Term Follow-Up of Targeted Biopsy Yield (LOFTY Study) in Ulcerative Colitis Surveillance Colonoscopy.,"We previously performed a randomized controlled trial (RCT) comparing targeted and random biopsy in neoplasia detection in patients with ulcerative colitis (UC), which showed the short-term effectiveness of targeted biopsy with one-time colonoscopy. In this retrospective cohort study, we investigated the long-term effectiveness of targeted biopsy in tertiary care hospitals, using the follow-up data from patients with UC for ≥ 8 years who had enrolled in the initial RCT. The primary outcome was death from colorectal cancer (CRC). Secondary outcomes were advanced neoplasia (CRC or high-grade dysplasia) and colectomy due to neoplasia after the RCT. We compared these outcomes between target and random groups. Data on 195 of the 221 patients (88.2%) enrolled in the previous RCT were collected from 28 institutions between 2008 and 2019. No patients died of CRC in either group, with a median 8.8-year follow-up demonstrating a robustness for targeted biopsy in terms of CRC death prevention. Advanced neoplasia was detected in four and three patients in the target and random groups, respectively. Colectomy was required due to neoplasia in three patients in each group. The chance of developing CRC in patients with a negative colonoscopy was low, and the targeted biopsy appeared effective in this population. Conversely, patients found with low-grade dysplasia at initial RCT have 10-fold higher risk of progression to high-grade dysplasia and/or CRC. Ten extracolonic malignancies were observed during the follow-up, resulting in four deaths. Panchromoendoscopy was used only in 4.6% and targeted biopsy was only performed in 59.1% of colonoscopies. We recommend targeted biopsy rather than > 33 random biopsies in real-world settings under adequate observation by specialists.",2020,"The chance of developing CRC in patients with a negative colonoscopy was low, and the targeted biopsy appeared effective in this population.","['patients with ulcerative colitis (UC', 'patients with UC for ≥ 8 years who had enrolled in the initial RCT', 'Ulcerative Colitis Surveillance Colonoscopy', 'Data on 195 of the 221 patients (88.2%) enrolled in the previous RCT were collected from 28 institutions between 2008 and 2019']","['random biopsy', 'Panchromoendoscopy']","['Advanced neoplasia', 'advanced neoplasia (CRC or high-grade dysplasia) and colectomy due to neoplasia after the RCT', 'died of CRC', 'death from colorectal cancer (CRC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0009274', 'cui_str': 'Excision of colon'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",28.0,0.0353662,"The chance of developing CRC in patients with a negative colonoscopy was low, and the targeted biopsy appeared effective in this population.","[{'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Hata', 'Affiliation': 'Department of Surgical Oncology, The University Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.'}, {'ForeName': 'Soichiro', 'Initials': 'S', 'LastName': 'Ishihara', 'Affiliation': 'Department of Surgical Oncology, The University Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Ajioka', 'Affiliation': 'Division of Molecular and Diagnostic Pathology, Niigata University Graduate School of Medical and Dental Sciences, 1-757 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Mitsuyama', 'Affiliation': 'Inflammatory Bowel Disease Center, Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, 67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Center for Inflammatory Bowel Disease, Division of Internal Medicine, Hyogo College of Medicine, 1-1, Mukogawa-cho, Nishinomiya, Hyogo 663-8501, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Hanai', 'Affiliation': 'Center for Gastroenterology & IBD Research Hamamatsu South Hospital, 26 Shirowa-cho, Minami-ku, Hamamatsu 430-0846, Japan.'}, {'ForeName': 'Reiko', 'Initials': 'R', 'LastName': 'Kunisaki', 'Affiliation': 'Inflammatory Bowel Disease Center, Yokohama City University Medical Center, 4-57 Urafune, Minami-ku, Yokohama 232-0024, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nakase', 'Affiliation': 'Department of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine, S-1, W-16, Chuo-ku, Sapporo 060-8543 Japan.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Matsuda', 'Affiliation': 'Department of Surgery, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi-Ku, Tokyo 117-0033, Japan.'}, {'ForeName': 'Ryuichi', 'Initials': 'R', 'LastName': 'Iwakiri', 'Affiliation': 'Faculty of Medicine, Saga University, 5-1-1, Nabeshima, Saga 849-8501, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Hida', 'Affiliation': 'Center for Inflammatory Bowel Disease, Division of Internal Medicine, Hyogo College of Medicine, 1-1, Mukogawa-cho, Nishinomiya, Hyogo 663-8501, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Endoscopy, Hiroshima University Hospital, 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Takeuchi', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Showa University School of Medicine, 1-5-8, Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Shinozaki', 'Affiliation': 'Department of Surgery, the Institute of Medical Science, the University of Tokyo, Tokyo 108-8639, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Ogata', 'Affiliation': 'Digestive Disease Center, Showa University Northern Yokohama Hospital, 35-1 Chigasaki-chuo, Tsuzuki Yokohama 224-8503, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Moriichi', 'Affiliation': 'Division of Gastroenterology and Hematology/Oncology, Department of Medicine, Asahikawa Medical University, Asahikawa 078-8510, Japan.'}, {'ForeName': 'Fumihito', 'Initials': 'F', 'LastName': 'Hirai', 'Affiliation': 'Department of Gastroenterology and Medicine, Fukuoka University Faculty of Medicine, 7-45-1 Nakanuma, Jonan-ku, Fukuoka 814-0180, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Sugihara', 'Affiliation': 'Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan.'}, {'ForeName': 'Tadakazu', 'Initials': 'T', 'LastName': 'Hisamatsu', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kyorin University School of Medicine, 6-20-2 Shinkawa, Mitaka-shi, Tokyo 181-8611, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Inflammatory Bowel Disease Center, Toho University Sakura Medical Center, 564-1 Shimoshizu, Sakura, Chiba 285-8741, Japan.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Gastroenterology and Hepatology, Advanced Research Institute, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Hibi', 'Affiliation': 'Center for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University, 5-9-1 Shirokanedai, Minato-ku, Tokyo 108-8642, Japan.'}]",Journal of clinical medicine,['10.3390/jcm9072286']
1568,32709590,An individualised self-management exercise and education program did not prevent recurrence of low back pain but may reduce care seeking: a randomised trial.,"QUESTION


What is the effect of a McKenzie-based self-management exercise and education program on the risk of recurrence of low back pain (LBP) and on the impact of LBP?
DESIGN


Randomised controlled trial with concealed allocation, blinded assessors and intention-to-treat analysis.
PARTICIPANTS


262 adults recently recovered from an episode of LBP.
INTERVENTION


The experimental group received a McKenzie-based self-management exercise and education program delivered over two individual sessions of 30 to 45 minutes with a physiotherapist, approximately 2 weeks apart. The control group received a single advice session over the phone.
OUTCOME MEASURES


The primary outcome was time to first recurrence of an episode of activity-limiting LBP. Secondary outcomes included time to recurrence of any LBP, time to a recurrence causing care seeking and a composite measure of pain and function ('impact of LBP'). Participants were followed-up monthly for ≥ 12 months.
RESULTS


The estimated effect of the experimental intervention on the risk of recurrence of an episode of: activity-limiting LBP was HR 1.11 (95% CI 0.80 to 1.54), any LBP was HR 0.95 (95% CI 0.72 to 1.26), and LBP for which care was sought was HR 0.69 (95% CI 0.46 to 1.04). The quarterly estimates of the experimental intervention's effect on impact of LBP and their 95% CIs were all within 4 points above or below 0 (no effect) on this scale from 8 to 50.
CONCLUSION


This study's best estimate is that a McKenzie-based self-management exercise and education program does not produce a worthwhile reduction in the risk of an activity-limiting episode of LBP; however, modestly reduced or moderately increased risk cannot be ruled out. It may markedly reduce the risk of an episode of LBP resulting in care seeking, but does not have any worthwhile effect on the impact of LBP over 12 months.
TRIAL REGISTRATION


ACTRN12616000926437.",2020,"It may markedly reduce the risk of an episode of LBP resulting in care seeking, but does not have any worthwhile effect on the impact of LBP over 12 months.
",['262 adults recently recovered from an episode of LBP'],"['single advice session', 'McKenzie-based self-management exercise and education program', 'individualised self-management exercise and education program']","[""time to recurrence of any LBP, time to a recurrence causing care seeking and a composite measure of pain and function ('impact of LBP"", 'time to first recurrence of an episode of activity-limiting LBP', 'risk of recurrence of an episode of: activity-limiting LBP', 'LBP']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",262.0,0.199324,"It may markedly reduce the risk of an episode of LBP resulting in care seeking, but does not have any worthwhile effect on the impact of LBP over 12 months.
","[{'ForeName': 'Tarcisio F', 'Initials': 'TF', 'LastName': 'de Campos', 'Affiliation': 'Department of Health Professions, Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, Australia. Electronic address: tarcisio.de-campos@hdr.mq.edu.au.'}, {'ForeName': 'Natasha C', 'Initials': 'NC', 'LastName': 'Pocovi', 'Affiliation': 'Department of Health Professions, Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Chris G', 'Initials': 'CG', 'LastName': 'Maher', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Clare', 'Affiliation': 'Helen Clare Physiotherapy, Sydney, Australia.'}, {'ForeName': 'Tatiane M', 'Initials': 'TM', 'LastName': 'da Silva', 'Affiliation': 'Master and Doctoral Programs in Physical Therapy, Universidade Cidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Hancock', 'Affiliation': 'Department of Health Professions, Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, Australia.'}]",Journal of physiotherapy,['10.1016/j.jphys.2020.06.006']
1569,32706731,Validation of a Mobile Version of the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form: An Observational Randomized Crossover Trial.,"BACKGROUND


The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) questionnaire is an effective tool for evaluating shoulder joint function. The development and usage of a mobile version of the ASES questionnaire has the potential to save time, money, and effort.
OBJECTIVE


The aim of this study is to assess the equivalence between the paper and mobile versions of the ASES questionnaire and their acceptability among patients.
METHODS


The paper and mobile versions of the ASES questionnaire were used to evaluate the shoulder joint function of 50 patients with shoulder pain. This study included patients from the shoulder clinic of Sun Yat-sen Memorial Hospital. The intraclass correlation coefficient (ICC) and Bland-Altman method were used to evaluate the agreement (reliability) of the scores obtained by the two methods (paper versus mobile).
RESULTS


Of the 50 patients recruited from March 2018 to May 2019, 46 (92%) completed the study. There was a high agreement between the paper and mobile versions of the ASES questionnaire (ICC=0.979, 95% CI 0.943-0.987; P<.001). The mean difference between the scores of the mobile and paper versions was 1.0, and only 1/46 (2%) had a difference greater than the minimal clinically important difference of 12 points. About 75% of patients preferred the mobile version to the paper version.
CONCLUSIONS


Our study shows that the mobile version of the ASES questionnaire is comparable to the paper version, and has a higher patient preference. This could prove to be a useful tool for epidemiological studies and patient follow-up over longer periods of time.",2020,"There was a high agreement between the paper and mobile versions of the ASES questionnaire (ICC=0.979, 95% CI 0.943-0.987; P<.001).","['American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form', '50 patients recruited from March 2018 to May 2019, 46 (92%) completed the study', '50 patients with shoulder pain', 'patients', 'patients from the shoulder clinic of Sun Yat-sen Memorial Hospital']",['Elbow Surgeons Standardized Shoulder Assessment Form (ASES) questionnaire'],[],"[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036644', 'cui_str': 'Senegal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",[],50.0,0.0611349,"There was a high agreement between the paper and mobile versions of the ASES questionnaire (ICC=0.979, 95% CI 0.943-0.987; P<.001).","[{'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Qingyue', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Menglei', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Fangqi', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yiyong', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Long', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yamuhanmode', 'Initials': 'Y', 'LastName': 'Alike', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yuanhao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Maslah Idiris', 'Initials': 'MI', 'LastName': 'Ali', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Congda', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}]",JMIR mHealth and uHealth,['10.2196/16758']
1570,32707605,Ten-year follow-up of a randomized controlled clinical trial in chronic hepatitis delta.,"Hepatitis delta virus (HDV) infection causes the most severe form of viral hepatitis. PEG-interferon alpha-2a (PEG-IFNα-2a) is the only effective treatment but its long-term clinical impact is unclear. The aim of this study was to investigate the long-term outcome after 48 weeks of pegylated interferon alpha-2a therapy. We performed a retrospective follow-up study of the Hep-Net-International-Delta-Hepatitis-Intervention-Study 1 (HIDIT-I trial). Patients had received 48 weeks of treatment with either PEG-IFNα-2a plus adefovir dipivoxil (ADV) (Group I), PEG-IFNα-2a alone (Group II) or adefovir dipivoxil alone (Group III). Liver-related complications were defined as liver-related death, liver transplantation, liver cancer and hepatic decompensation defined as development of Child-Pugh scores B or C or an increase in Model for End-stage Liver Disease (MELD) scores of five or more points in relation to baseline values. Patients were considered for further analysis when they were retreated with PEG-IFNα-2a. Follow-up data (at least 1 visit beyond post-treatment week 24) were available for 60 patients [Group I, (n = 19), Group II (n = 20), Group III (n = 21)]. Mean time of follow-up was 8.9 (1.6 - 13.4) years. 19 patients were retreated with IFN-based therapy: 42% (n = 8) in PEG-IFNα-2a arms and 58% (n = 11) in the adefovir only arm. Clinical complications on long-term follow-up occurred in 17 patients and were associated with nonresponse to therapy and baseline cirrhosis. The annual event-free survival rate in patients with cirrhosis vs noncirrhotic patients at year 5 and 10 was 70% vs 91% and 35% vs 76%. Long-term follow-up of a large randomized clinical trial suggests that off-treatment HDV RNA response to PEG-IFNα-2a treatment leads to improved clinical long-term outcome.",2020,"Liver-related complications were defined as liver-related death, liver transplantation, liver cancer and hepatic decompensation defined as development of Child Pugh scores B or C or an increase in Model for Endstage Liver Disease (MELD) scores of five or more points in relation to baseline values.","['19 patients were re-treated with', 'chronic hepatitis delta', 'patients with cirrhosis vs non-cirrhotic patients', '17 patients']","['PEG-interferon alpha-2a (PEG-IFNα-2a', 'Hep-Net-International-Delta-Hepatitis-Intervention', 'IFN-based therapy', 'PEG-IFNα-2a', 'pegylated interferon alfa-2a therapy', 'PEG-IFNα-2a plus adefovir dipivoxil (ADV) (Group I), PEG-IFNα-2a alone (Group II), or adefovir dipivoxil alone']","['survival rate', 'Clinical complications', 'liver-related death, liver transplantation, liver cancer and hepatic decompensation', 'Mean time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0019189', 'cui_str': 'Chronic hepatitis'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0439687', 'cui_str': 'Non-cirrhotic'}]","[{'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0021734', 'cui_str': 'Interferon Alfa-2a'}, {'cui': 'C0162569', 'cui_str': 'Homozygous porphyria cutanea tarda'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0011226', 'cui_str': 'Viral hepatitis D'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0540694', 'cui_str': 'adefovir dipivoxil'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0345904', 'cui_str': 'Malignant neoplasm of liver'}, {'cui': 'C1394798', 'cui_str': 'Hepatic decompensation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",19.0,0.0815091,"Liver-related complications were defined as liver-related death, liver transplantation, liver cancer and hepatic decompensation defined as development of Child Pugh scores B or C or an increase in Model for Endstage Liver Disease (MELD) scores of five or more points in relation to baseline values.","[{'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Wranke', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Svenja', 'Initials': 'S', 'LastName': 'Hardtke', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Heidrich', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Dalekos', 'Affiliation': 'Department of Medicine and Research Laboratory of Internal Medicine, University Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Kendal', 'Initials': 'K', 'LastName': 'Yalçin', 'Affiliation': 'Dicle University Medical Faculty, Diyarbakir, Turkey.'}, {'ForeName': 'Fehmi', 'Initials': 'F', 'LastName': 'Tabak', 'Affiliation': 'Department of Infectious Diseases Cerrahpaşa School of Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Selim', 'Initials': 'S', 'LastName': 'Gürel', 'Affiliation': 'Uludağ University Medical School, Bursa, Turkey.'}, {'ForeName': 'Yilmaz', 'Initials': 'Y', 'LastName': 'Çakaloğlu', 'Affiliation': 'Memorial Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ulus S', 'Initials': 'US', 'LastName': 'Akarca', 'Affiliation': 'Ege University Medical Faculty, Izmir, Turkey.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lammert', 'Affiliation': 'Department of Medicine II, Saarland University Medical Center, Saarland University, Homburg, Germany.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Häussinger', 'Affiliation': 'Department of Gastroenterology, Hepatology and Infectious Diseases, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Müller', 'Affiliation': 'Charite University, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wöbse', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Manns', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Ramazan', 'Initials': 'R', 'LastName': 'Idilman', 'Affiliation': 'Department of Gastroenterology, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Cornberg', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Heiner', 'Initials': 'H', 'LastName': 'Wedemeyer', 'Affiliation': 'German Center for Infection Research (DZIF), Partner Site HepNet Study-House, Hannover, Germany.'}, {'ForeName': 'Cihan', 'Initials': 'C', 'LastName': 'Yurdaydin', 'Affiliation': 'Department of Gastroenterology, Ankara University School of Medicine, Ankara, Turkey.'}]",Journal of viral hepatitis,['10.1111/jvh.13366']
1571,32715828,Five-Year Outcomes Prospective Study of Two First-Generation Trabecular Micro-Bypass Stents (iStent®) in Open-Angle Glaucoma.,"PURPOSE


To assess 5-year effectiveness and safety of 2 iStent® trabecular micro-bypass stents in eyes with open-angle glaucoma (OAG) not controlled on 1 medication.
MATERIALS AND METHODS


This prospective, interventional, single-arm, multi-surgeon study (NCT #1252862, clinicaltrials.gov) enrolled eyes with OAG, preoperative intraocular pressure (IOP) of 18-30 mmHg on 1 ocular hypotensive medication, and 22-38 mmHg after medication washout. Eyes underwent standalone implantation of 2 iStent devices and were followed through 60 months postoperatively. Efficacy was quantified by mean diurnal IOP and medication usage. Efficacy endpoints included the proportion of eyes with ≥20% IOP reduction versus baseline unmedicated IOP (primary efficacy), and the proportion of eyes with IOP ≤18 mmHg (secondary efficacy) without medication or secondary glaucoma surgery. Safety parameters included visual acuity, cup-to-disc ratio, visual field, and complications and adverse events.
RESULTS


Preoperative mean IOP on 1 medication was 20.6 ± 2.0 mmHg and post-washout unmedicated IOP was 24.1 ± 1.4 mmHg (n = 39). At 5 years postoperative, medication-free mean diurnal IOP reduced to 14.5 ± 2.2 mmHg, constituting a 40% decrease versus preoperative washed-out IOP ( p  < .0001). In addition, this 5-year medication-free IOP constituted a 30% decrease versus preoperative IOP on 1 medication ( p  < .0001). At Month 60, 89.7% (26/29) of eyes achieved the primary efficacy endpoint of ≥20% IOP reduction versus baseline unmedicated IOP, and 86.2% (25/29) of eyes achieved the secondary efficacy endpoint of IOP ≤18 mmHg, without medication or secondary glaucoma surgery. Throughout follow-up, 89.7-91.3% of eyes were on no medications. Favorable safety included no secondary glaucoma surgeries, minimal adverse events, and stable visual acuity, cup-to-disc ratio, and visual fields through 5 years postoperative.
CONCLUSIONS


This prospective interventional study demonstrates persistent 5-year reductions in IOP and freedom from medications, together with favorable safety, following implantation of 2 first-generation trabecular micro-bypass stents in eyes with OAG on 1 preoperative medication.",2020,"At 5 years postoperative, medication-free mean diurnal IOP reduced to 14.5 ± 2.2 mmHg, constituting a 40% decrease versus preoperative washed-out IOP ( p  < .0001).","['eyes with OAG on 1 preoperative medication', 'eyes with open-angle glaucoma (OAG', 'multi-surgeon study (NCT #1252862, clinicaltrials.gov) enrolled eyes with OAG, preoperative intraocular pressure (IOP) of 18-30\xa0mmHg on 1 ocular hypotensive medication, and 22-38\xa0mmHg after medication washout']","['2 iStent® trabecular micro-bypass stents', 'Two First-Generation Trabecular Micro-Bypass Stents (iStent®', 'implantation of 2 first-generation trabecular micro-bypass stents', 'standalone implantation of 2 iStent devices']","['5-year medication-free IOP', 'visual acuity, cup-to-disc ratio, visual field, and complications and adverse events', 'proportion of eyes with ≥20% IOP reduction versus baseline unmedicated IOP (primary efficacy', 'Efficacy', 'secondary glaucoma surgeries, minimal adverse events, and stable visual acuity, cup-to-disc ratio, and visual fields through 5\xa0years postoperative', 'medication-free mean diurnal IOP', '5-year effectiveness and safety', 'proportion of eyes with IOP ≤18\xa0mmHg (secondary efficacy) without medication or secondary glaucoma surgery']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}]","[{'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0423471', 'cui_str': 'Optic cup/disc ratio'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0149893', 'cui_str': 'Secondary glaucoma'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",,0.0665154,"At 5 years postoperative, medication-free mean diurnal IOP reduced to 14.5 ± 2.2 mmHg, constituting a 40% decrease versus preoperative washed-out IOP ( p  < .0001).","[{'ForeName': 'Hady', 'Initials': 'H', 'LastName': 'Saheb', 'Affiliation': 'Department of Ophthalmology, McGill University , Montreal, Quebec, Canada.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Donnenfeld', 'Affiliation': 'Ophthalmic Consultants of Long Island , Rockville Centre, New York, USA.'}, {'ForeName': 'Kerry D', 'Initials': 'KD', 'LastName': 'Solomon', 'Affiliation': 'Carolina Eyecare Physicians , Mt Pleasant, South Carolina, USA.'}, {'ForeName': 'Lilit', 'Initials': 'L', 'LastName': 'Voskanyan', 'Affiliation': 'S.V. Malayan Ophthalmology Center , Yerevan, Armenia.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Chang', 'Affiliation': 'Altos Eye Physicians , Los Altos, California, USA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Samuelson', 'Affiliation': 'Minnesota Eye Consultants , Minneapolis, Minnesota, USA.'}, {'ForeName': 'Iqbal Ike K', 'Initials': 'IIK', 'LastName': 'Ahmed', 'Affiliation': 'Department of Ophthalmology, University of Toronto , Toronto, Ontario, Canada.'}, {'ForeName': 'L Jay', 'Initials': 'LJ', 'LastName': 'Katz', 'Affiliation': 'Department of Ophthalmology, Wills Eye Hospital, Jefferson Medical College , Philadelphia, Pennsylvania, USA.'}]",Current eye research,['10.1080/02713683.2020.1795881']
1572,32717294,A Novel Link between the Oxytocin Receptor Gene and Impulsivity.,"Impulsivity includes hasty actions, social intrusiveness or premature decision-making. Neuropeptides like oxytocin alleviate haste and anxiety, and affect fear conditioning. However, no investigations have been done via gene-network based approach with cognitive and interventional genetic association studies to scrutinize the link between impulsive behavior and oxytocin. Here, interactive gene network and pathways associated with impulsivity were reconstructed, and serotonin transporter gene (SLC6A4) and serotoninergic synaptic transmission were identified as the most central gene and pathway related to impulsivity. Young healthy males received intranasal oxytocin or placebo, and impulsivity was evaluated via go/no-go test. Test performance scores then were analyzed based on commission and omission errors, response inhibition and reaction time. Blood DNA was extracted and a 761 bp intronic region in oxytocin receptor (OXTR) gene was amplified and sequenced using PCR-pyrosequencing. Employing Haploview, haplotypes and linkage disequilibrium (LD) pattern among all SNPs in the target sequence were determined based on D' and LOD values, and rs2254298 with the highest LD was indicated as the tag SNP. Oxytocin group and participants with GG genotype showed a significantly decreased commission error and increased inhibition. This means that oxytocin alleviated impulsive behavior, and subjects with GG genotype had lower rate of impulsivity than those with GA and AA genotypes. rs2254298 may modulate the function or expression of the OXTR gene, implying that G allele may increase the expression of OXTR gene compared to A allele. We suggest that intranasal oxytocin may notably moderate impulsive behavior and tendency to make hasty or premature decisions.",2020,Oxytocin group and participants with GG genotype showed a significantly decreased commission error and increased inhibition.,['Young healthy males'],"['Oxytocin', 'oxytocin', 'intranasal oxytocin or placebo', 'intranasal oxytocin']","['commission and omission errors, response inhibition and reaction time', 'Impulsivity includes hasty actions, social intrusiveness or premature decision-making', 'Blood DNA', 'rate of impulsivity', 'commission error and increased inhibition']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.034954,Oxytocin group and participants with GG genotype showed a significantly decreased commission error and increased inhibition.,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Bozorgmehr', 'Affiliation': 'Iran Psychiatric Hospital, Iran University of Medical Sciences (IUMS), Tehran, Iran. Electronic address: bozorgmehr.a@iums.ac.ir.'}, {'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Moayedi', 'Affiliation': 'Department of Mathematics, Payam Noor University of Tehran, Tehran, Iran.'}, {'ForeName': 'Bahman', 'Initials': 'B', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Biochemistry, Institute of Biochemistry and Biophysics (IBB), University of Tehran, Tehran, Iran. Electronic address: bahman.sadeghi@ut.ac.ir.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ghadirivasfi', 'Affiliation': 'Research Center for Addiction and Risky Behavior (ReCARB), Iran University of Medical Sciences (IUMS), Tehran, Iran. Electronic address: gadirivasfi.m@iums.ac.ir.'}, {'ForeName': 'Mohammad Taghi', 'Initials': 'MT', 'LastName': 'Joghataei', 'Affiliation': 'Cellular and Molecular Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Shahbazi', 'Affiliation': 'Cellular and Molecular Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran; Department of Neuroscience, Faculty of Advanced Technologies in Medicine, Iran University of Medical Sciences (IUMS), Tehran, Iran. Electronic address: shahbazi.a@iums.ac.ir.'}]",Neuroscience,['10.1016/j.neuroscience.2020.07.033']
1573,32717696,Using unfolding case studies to develop critical thinking skills in baccalaureate nursing students: A pilot study.,"BACKGROUND


Research has consistently demonstrated that new graduate nurses do not possess sufficient critical thinking skills when they transition to clinical practice. Unfolding case studies encourage students to participate in a number of critical thinking skills including information-seeking, logical reasoning, and analyzing of clinical data.
OBJECTIVE


The aim of this study was to determine how the use of unfolding case studies as a learning modality affected baccalaureate students' critical thinking skills in their Adult Health Theory course. The researcher compared course examination scores earned by nursing students who were taught using traditional case studies to scores obtained by nursing students who completed unfolding case studies.
SETTING


The pilot study took place at a moderate-sized comprehensive university in Wisconsin.
DESIGN


A non-experimental correlational design using course examination scores data was employed to examine how the use of unfolding case studies as a learning modality affected baccalaureate students' critical thinking skills in their Adult Health Theory course.
PARTICIPANTS


A total of 160 students comprised the intervention group while an additional 142 students represented the control group in the study.
METHODS


An independent-samples t-test was performed to explore differences in mean scores between the intervention and control groups.
RESULTS


Results of the t-test indicate that mean examination scores were significantly higher for the intervention group (M = 234.9, SD = 13.1) than for the control group (M = 228.2, SD = 13.3); t(299) =, p < .001.
CONCLUSIONS


Results of this study suggest that unfolding case studies more effectively develop students' critical thinking skills than do a more traditional, static case study.",2020,"RESULTS


Results of the t-test indicate that mean examination scores were significantly higher for the intervention group (M = 234.9, SD = 13.1) than for the control group (M = 228.2, SD = 13.3); t(299) =, p < .001.
","['A total of 160 students comprised the intervention group while an additional 142 students represented the control group in the study', 'baccalaureate nursing students', 'The pilot study took place at a moderate-sized comprehensive university in Wisconsin']",[],"['mean scores', 'mean examination scores']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",160.0,0.0283034,"RESULTS


Results of the t-test indicate that mean examination scores were significantly higher for the intervention group (M = 234.9, SD = 13.1) than for the control group (M = 228.2, SD = 13.3); t(299) =, p < .001.
","[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Englund', 'Affiliation': 'University of Wisconsin Oshkosh, College of Nursing, 800 Algoma Blvd, Oshkosh, WI, United States of America. Electronic address: englundh@uwosh.edu.'}]",Nurse education today,['10.1016/j.nedt.2020.104542']
1574,32717713,"Effect of lifetime antiepileptic drug treatment history on efficacy and tolerability of adjunctive brivaracetam in adults with focal seizures: Post-hoc analysis of a randomized, placebo-controlled trial.","OBJECTIVE


To evaluate the efficacy and tolerability of adjunctive brivaracetam (BRV) in adults with focal seizures by the number of lifetime (previous and concomitant) antiepileptic drugs (AEDs).
METHODS


Post-hoc analysis of data from N01358 (NCT01261325), a randomized, double-blind, placebo (PBO)-controlled Phase III trial evaluating BRV 100 and 200 mg/day in patients ≥16 years of age with uncontrolled focal seizures. Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
RESULTS


764 patients received at least one dose of trial medication (BRV: 503; PBO: 261; Safety Set), of whom 14.3% had 1-2, 20.8% had 3-4, 21.3% had 5-6, and 43.6% had ≥7 lifetime AEDs. In all lifetime AED subgroups, >85% of patients completed the trial. Patients with a higher number of lifetime AEDs had a younger age at epilepsy onset, longer epilepsy duration, and higher baseline seizure frequency. In patients on BRV, 50% responder rates were 49.3%, 44.4%, 47.2% and 27.4% in patients with 1-2 (n = 75), 3-4 (n = 99), 5-6 (n = 108) and ≥7 (n = 219) lifetime AEDs; 75% responder rates were 36.0%, 21.2%, 22.2% and 12.3%. In patients on PBO, 50% responder rates were 35.3%, 25.9%, 20.4% and 15.9% in patients with 1-2 (n = 34), 3-4 (n = 58), 5-6 (n = 54) and ≥7 (n = 113) lifetime AEDs; 75% responder rates were 26.5%, 6.9%, 3.7% and 4.4%. The Kaplan-Meier estimated probability of patients achieving a sustained 50% or 75% response from the first day of treatment was generally higher in patients with a lower number of lifetime AEDs (both in patients on BRV and PBO). In patients on adjunctive BRV, the incidence of drug related treatment-emergent adverse events (TEAEs) was 34.7%, 26.0%, 44.4% and 47.7% in patients with 1-2 (n = 75), 3-4 (n = 100), 5-6 (n = 108) and ≥7 (n = 220) lifetime AEDs; the incidence of discontinuations due to TEAEs was 1.3%, 3.0%, 8.3% and 10.5%.
CONCLUSIONS


This post-hoc analysis suggests a numerically higher response to adjunctive BRV in patients with fewer lifetime AEDs. The lowest response was observed in patients with ≥7 lifetime AEDs, although these patients could also benefit from adjunctive BRV treatment. Patients with fewer lifetime AEDs had lower discontinuation of BRV due to TEAEs.",2020,"Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
","['adults with focal seizures by the number of lifetime (previous and concomitant) antiepileptic drugs (AEDs', 'adults with focal seizures', 'subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs', 'patients ≥16 years of age with uncontrolled focal seizures']","['adjunctive brivaracetam (BRV', 'adjunctive brivaracetam', 'placebo']","['Efficacy and tolerability outcomes', 'responder rates', 'incidence of drug related treatment-emergent adverse events (TEAEs', 'efficacy and tolerability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0442749', 'cui_str': '6/5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}]","[{'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",764.0,0.103758,"Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
","[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, 6410 Rockledge Drive, Suite 610, Bethesda, MD 20817, USA. Electronic address: kleinp@epilepsydc.com.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'McLachlan', 'Affiliation': 'Western University, 339 Windermere Road, London, ON N6A 5A5, Canada. Electronic address: rsmcl@uwo.ca.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Foris', 'Affiliation': 'UCB Pharma, 2060 Winston Park Drive, Suite 401, Oakville, ON L6H 5R7, Canada. Electronic address: kforis@sympatico.ca.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Nondonfaz', 'Affiliation': ""UCB Pharma, Chemin du Foriest, 1420 Braine-l'Alleud, Belgium. Electronic address: xavier.nondonfaz@ucb.com.""}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Elmoufti', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: sami.elmoufti@ucb.com.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Dimova', 'Affiliation': 'UCB Pharma, Allée de la Recherche 60, 1070 Brussels, Belgium. Electronic address: svetlana.dimova@ucb.com.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Bethel Epilepsy Center, Mara Hospital, Maraweg 21, 33617 Bielefeld, Germany. Electronic address: christian.brandt@mara.de.'}]",Epilepsy research,['10.1016/j.eplepsyres.2020.106369']
1575,32718746,"Electromyographic biofeedback improves upper extremity function: a randomized, single-blinded, controlled trial.","OBJECTIVE


To examine the effects of a 6-week surface electromyographic biofeedback intervention on the re-learning of upper extremity motor function in subjects with paretic upper extremity after stroke.
DESIGN


A randomized controlled trial.
SETTING


State Centre of Attention to Brain Injury, Madrid, Spain.
PARTICIPANTS


Thirty-eight participants in the sub-acute post-stroke stage were recruited and randomly allocated into either the surface electromyographic biofeedback (sEMG-BFB) or sham biofeedback (BFB) groups.
INTERVENTIONS


The sEMG-BFB group (n=19) received the intervention focused on re-learning scapulothoracic control during arm-reaching tasks involving shoulder abduction. The sham BFB group (n=19) received a sham intervention.
OUTCOME MEASURES


Upper extremity motor function assessed using the Fugl-Meyer Assessment-Upper Extremity Scale (66 points), the glenohumeral active range of motion, and the electromyographic amplitude signal of the middle deltoid and upper trapezius muscles were collected at baseline, after the intervention, and at the one-month follow-up.
RESULTS


Compared with the sham BFB group, the sEMG-BFB group experienced significant increases in upper extremity motor function after the intervention. The mean differences between groups were as follows: 4.79 points (95% CI 2.92 to 6.66) after the intervention; 6.55 points (95% CI 3.75 to 9.34) at the one-month follow-up; improved active range of motion 15.75 points (95% CI 6 to 30) after the intervention and electromyographic activity in the upper trapezius muscle changed in favour of the sEMG-BFB.
CONCLUSIONS


In the short term, a 6-week sEMG-BFB intervention effectively improved paretic upper limb motor function. Future research is needed to determine if the sEMG-BFB intervention has any long-term effects. Clinical trial number registration: NCT02974465 (ClinicalTrials.gov).",2020,"In the short term, a 6-week sEMG-BFB intervention effectively improved paretic upper limb motor function.","['Thirty-eight participants in the sub-acute post-stroke stage', 'subjects with paretic upper extremity after stroke', 'State Centre of Attention to Brain Injury, Madrid, Spain']","['sEMG-BFB intervention', 'sEMG-BFB', 'intervention focused on re-learning scapulothoracic control during arm-reaching tasks involving shoulder abduction', 'surface electromyographic biofeedback intervention', 'Electromyographic biofeedback', 'sham BFB', 'surface electromyographic biofeedback (sEMG-BFB) or sham biofeedback (BFB) groups', 'sham intervention']","['Fugl-Meyer Assessment-Upper Extremity Scale', 'paretic upper limb motor function', 'glenohumeral active range of motion, and the electromyographic amplitude signal of the middle deltoid and upper trapezius muscles', 'upper extremity function', 'upper extremity motor function']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0204624', 'cui_str': 'Electromyographic biofeedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.0995422,"In the short term, a 6-week sEMG-BFB intervention effectively improved paretic upper limb motor function.","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Lirio-Romero', 'Affiliation': 'Faculty of Physiotherapy and Nursing, University of Castilla-La Mancha, Toledo, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Torres-Lacomba', 'Affiliation': ""Physiotherapy in Women's Health (FPSM) Research Group, University of Alcalá, Madrid, Spain. Electronic address: maria.torres@uah.es.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gómez-Blanco', 'Affiliation': 'State Center of Attention to Brain Injury, Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Acero-Cortés', 'Affiliation': 'State Center of Attention to Brain Injury, Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Retana-Garrido', 'Affiliation': 'State Center of Attention to Brain Injury, Madrid, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'de la Villa-Polo', 'Affiliation': ""Physiotherapy in Women's Health (FPSM) Research Group, University of Alcalá, Madrid, Spain.""}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Sánchez-Sánchez', 'Affiliation': ""Physiotherapy in Women's Health (FPSM) Research Group, University of Alcalá, Madrid, Spain.""}]",Physiotherapy,['10.1016/j.physio.2020.02.002']
1576,32734732,"Effects of Air Purifiers on Patients with Allergic Rhinitis: a Multicenter, Randomized, Double-Blind, and Placebo-Controlled Study.","PURPOSE


Exposure to particulate matter (PM) is a well-known risk factor in the triggering and exacerbation of allergic airway disease. Indoor environments, where people spend most of their time, are of utmost importance. To assess the effects of air purifiers [equipped with high-efficiency particulate air (HEPA) filters] on allergic rhinitis (AR) in adult patients, we performed a multicenter, randomized, double-blind, and placebo-controlled study.
MATERIALS AND METHODS


Patients with house dust mite (HDM)-induced AR were randomly assigned to either active or mockup (placebo) air-purification groups. Two air purifiers (placed in living room and bedroom) were operated for 6 weeks in each home environment. The primary study endpoint was to achieve improvement in AR symptoms and medication scores. Secondary endpoints were to achieve improvement in the quality of life (QoL) and visual analog scale (VAS) scores, as well as in the indoor (bedroom and living room) concentrations of PM 2.5  and PM 10 .
RESULTS


After 6 weeks of air purifier use, medication scores improved significantly in the active (vs. placebo) group, although subjective measures (symptoms, VAS, and QoL scores) did not differ. Bedroom PM 2.5  concentrations initially exceeded living room or outdoor levels, but declined (by up to 51.8%) following active purifier operation. Concentrations of PM 2.5  in living room and PM 10  in bedroom and living room were also significantly reduced through active purification.
CONCLUSION


The use of air purifiers with HEPA filters significantly reduced medication requirements for patients with HDM-induced AR and significantly lowered indoor PM 2.5  concentrations, regardless of room placement. Active intervention to reduce household air pollutants may help improve allergic airway disease (clinicaltrials.gov NCT03313453).",2020,"After 6 weeks of air purifier use, medication scores improved significantly in the active (vs. placebo) group, although subjective measures (symptoms, VAS, and QoL scores) did not differ.","['allergic rhinitis (AR) in adult patients', 'Patients with house dust mite (HDM)-induced AR', 'Patients with Allergic Rhinitis']","['Placebo', 'air purifiers with HEPA filters', 'Two air purifiers (placed in living room and bedroom', 'active or mockup (placebo) air-purification groups', 'Air Purifiers', 'air purifiers [equipped with high-efficiency particulate air (HEPA) filters', 'placebo']","['AR symptoms and medication scores', 'Bedroom PM 2.5  concentrations initially exceeded living room or outdoor levels', 'medication scores', 'medication requirements', 'subjective measures (symptoms, VAS, and QoL scores', 'quality of life (QoL) and visual analog scale (VAS) scores, as well as in the indoor (bedroom and living room']","[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0998367', 'cui_str': 'House dust mite'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0262774', 'cui_str': 'Air Purifier'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0457784', 'cui_str': 'Particulate'}, {'cui': 'C0180861', 'cui_str': 'Air filter'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0557652', 'cui_str': 'Bedroom'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0243114', 'cui_str': 'purification'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0180860', 'cui_str': 'Filter'}]","[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0557652', 'cui_str': 'Bedroom'}, {'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.306739,"After 6 weeks of air purifier use, medication scores improved significantly in the active (vs. placebo) group, although subjective measures (symptoms, VAS, and QoL scores) did not differ.","[{'ForeName': 'Kyung Hee', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': 'Division of Allergy and Immunology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Da Woon', 'Initials': 'DW', 'LastName': 'Sim', 'Affiliation': 'Division of Allergy and Immunology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sang Chul', 'Initials': 'SC', 'LastName': 'Lee', 'Affiliation': 'Division of Allergy and Immunology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sunyoung', 'Initials': 'S', 'LastName': 'Moon', 'Affiliation': 'Air Care Advanced R&D, Home Appliance & Air Solution Company, LG Electronics, Seoul, Korea.'}, {'ForeName': 'Eunju', 'Initials': 'E', 'LastName': 'Choe', 'Affiliation': 'Division of Allergy and Immunology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyejung', 'Initials': 'H', 'LastName': 'Shin', 'Affiliation': 'Biostatistics Collaboration Unit, Department of Biomedical Systems Informatics, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sung Ryeol', 'Initials': 'SR', 'LastName': 'Kim', 'Affiliation': 'Division of Allergy and Immunology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jae Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Division of Allergy and Immunology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyung Ho', 'Initials': 'HH', 'LastName': 'Park', 'Affiliation': 'Air Care Advanced R&D, Home Appliance & Air Solution Company, LG Electronics, Seoul, Korea.'}, {'ForeName': 'Deok', 'Initials': 'D', 'LastName': 'Huh', 'Affiliation': 'Air Care Advanced R&D, Home Appliance & Air Solution Company, LG Electronics, Seoul, Korea.'}, {'ForeName': 'Jung Won', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Division of Allergy and Immunology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}]",Yonsei medical journal,['10.3349/ymj.2020.61.8.689']
1577,32731011,The effect of Hatha yoga intervention on students' creative ability.,"There is increasing demand for individual creativity as organizations seek innovative ways to remain relevant. Higher education institutions, particularly business schools, are sensitive to this demand and are constantly in search for innovative ways to enhance the creative ability of their students. Prior studies have shown encouraging results for physical activity-oriented interventions. Building on this research, this study uses Randomized Controlled Trial (RCT) to understand if an acute combinatory intervention, involving both physical and mental exercises embodied in Hatha yoga can improve individual creativity. This study uses 92 MBA student participants to investigate the impact of a 20-minute Hatha yoga session intervention against a short 20-minute case study session for the control group. Creative ability of the participants is operationalized through divergent and convergent thinking, which are then assessed through counter-balanced forms of Guilford Alternate Uses tasks and Remote Associate Test, respectively. The results show that while Hatha yoga significantly improves divergent thinking, the control group shows deterioration in divergent thinking. There is no effect on convergent thinking. These findings lend some support to the executive function hypothesis. The study also finds that prodding a person to be more creative on a routine academic task may not enhance their creative ability.",2020,There is no effect on convergent thinking.,"['92 MBA student participants', ""students' creative ability""]",['Hatha yoga intervention'],"['divergent thinking', 'individual creativity']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0010297', 'cui_str': 'Creative thought'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010297', 'cui_str': 'Creative thought'}]",92.0,0.0286741,There is no effect on convergent thinking.,"[{'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Bollimbala', 'Affiliation': 'Manipal Academy of Higher Education, Manipal, Karnataka, 576104, India; T A Pai Management Institute, Manipal, Karnataka, 576104, India. Electronic address: ashish@tapmi.edu.in.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'James', 'Affiliation': 'IFIM Business School, Bangalore, Karnataka, India.'}, {'ForeName': 'Shirshendu', 'Initials': 'S', 'LastName': 'Ganguli', 'Affiliation': 'T A Pai Management Institute, Manipal, Karnataka, 576104, India. Electronic address: shirshenduganguli@tapmi.edu.in.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103121']
1578,32735952,Acute hyperglycaemia can impair driving skill in young type 1 diabetes mellitus patients.,"AIM


Drivers with diabetes are at increased risk of being involved in road accidents. Therefore, this study aimed to evaluate the effects of acute hyperglycaemia (AH) compared with euglycaemia on driving ability in patients with type 1 diabetes mellitus (T1DM).
METHODS


Eighteen drivers with T1DM were asked to navigate twice through nine hazardous scenarios, using a driving simulator, during euglycaemia and then again during AH (mean blood glucose: 138 ± 34 mg/dL and 321 ± 29 mg/dL, respectively) in a counterbalanced crossover study. Driving performance was continually monitored for driving speed, steering wheel angle, acceleration, and location and velocity of other vehicles and obstacles, with drivers wearing a mobile head-mounted eye-tracking system.
RESULTS


The main findings were that, during AH, participants were less likely to identify a hazard [probability of identification (POI): 0.5725 ± 0.5], glanced fewer times at the hazard (3.24 ± 5.9), maintained shorter headway (between-vehicle) distance (mean: 40.87 ± 20.15 m) and had an increased number of braking events per km driven (6.69 ± 5.20) compared with driving during euglycaemia (POI: 0.733 ± 0.4; number of glances: 3.69 ± 6.99; headway distance: 50.46 ± 26.2 m; number of braking events per km driven: 4.31 ± 3.87; P <  0.05 for all parameters).
CONCLUSION


This study provides evidence that AH impairs driving performance in young T1DM patients by demonstrating the negative effects of AH on both hazard perception and speed management.",2020,"(mean blood glucose: 138 ± 34 mg/dL and 321 ± 29 mg/dL, respectively) in a counterbalanced crossover study.","['young T1DM patients', 'Eighteen drivers with T1DM', 'patients with type 1 diabetes mellitus (T1DM', 'young type 1 diabetes mellitus patients']","['navigate twice through nine hazardous scenarios, using a driving simulator, during euglycaemia and then again during AH', 'euglycaemia', 'acute hyperglycaemia (AH']",['number of braking events'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0342301', 'cui_str': 'Acute hyperglycemia'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0337108', 'cui_str': 'Brake'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.0707027,"(mean blood glucose: 138 ± 34 mg/dL and 321 ± 29 mg/dL, respectively) in a counterbalanced crossover study.","[{'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Haim', 'Affiliation': 'Pediatric Endocrinology & Diabetes Unit, Soroka University Medical Center, Beer Sheva, Israel; Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel. Electronic address: alonhaim@bgu.ac.il.'}, {'ForeName': 'Rotem', 'Initials': 'R', 'LastName': 'Shalev Shamy', 'Affiliation': 'Pediatric Endocrinology & Diabetes Unit, Soroka University Medical Center, Beer Sheva, Israel; Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Ridel', 'Affiliation': 'Department of Industrial Engineering & Management, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Yisrael', 'Initials': 'Y', 'LastName': 'Parmet', 'Affiliation': 'Department of Industrial Engineering & Management, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Neta', 'Initials': 'N', 'LastName': 'Loewenthal', 'Affiliation': 'Pediatric Endocrinology & Diabetes Unit, Soroka University Medical Center, Beer Sheva, Israel; Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Idit', 'Initials': 'I', 'LastName': 'Liberty', 'Affiliation': 'Department of Internal Medicine, Adult Diabetes Unit, Soroka University Medical Center, Beer Sheva, Israel.'}, {'ForeName': 'Shai', 'Initials': 'S', 'LastName': 'Tejman-Yarden', 'Affiliation': 'Edmond J. Safra International Congenital Heart Center, Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Hershkovitz', 'Affiliation': 'Pediatric Endocrinology & Diabetes Unit, Soroka University Medical Center, Beer Sheva, Israel; Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Avinoam', 'Initials': 'A', 'LastName': 'Borowsky', 'Affiliation': 'Department of Industrial Engineering & Management, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}]",Diabetes & metabolism,['10.1016/j.diabet.2020.07.003']
1579,32735987,"A two-site, open-label, non-randomized trial comparing Focal Electrically-Administered Seizure Therapy (FEAST) and right unilateral ultrabrief pulse electroconvulsive therapy (RUL-UBP ECT).","BACKGROUND


Focal Electrically-Administered Seizure Therapy (FEAST) is a form of electroconvulsive therapy (ECT) that spatially focuses the electrical stimulus to initiate seizure activity in right prefrontal cortex. Two open-label non-comparative studies suggested that FEAST has reduced cognitive side effects when compared to historical data from other forms of ECT. In two different ECT clinics, we compared the efficacy and cognitive side effects of FEAST and Right Unilateral Ultrabrief Pulse (RUL-UBP) ECT.
METHODS


Using a non-randomized, open-label design, 39 depressed adults were recruited after referral for ECT. Twenty patients received FEAST (14 women; age 45.2 ± 12.7), and 19 received RUL-UBP ECT (16 women; age 43.2 ± 16.4). Key cognitive outcome measures were the postictal time to reorientation and the Columbia University Autobiographical Memory Interview: Short-Form (CUAMI-SF). Antidepressant effects were assessed using the Hamilton Rating Scale for Depression (HRSD 24 ).
RESULTS


In the Intent-to-treat sample, a repeated measures mixed model suggested no between group difference in HRSD 24  score over time (F 1,35  = 0.82, p = 0.37), while the response rate favored FEAST (FEAST: 65%; RUL-UBP ECT: 57.9%), and the remission rate favored RUL-UBP ECT (FEAST: 35%; RUL-UBP ECT: 47.4%). The FEAST group had numeric superiority in average time to reorientation (FEAST: 6.6 ± 5.0 min; RUL-UBP ECT: 8.8 ± 5.8 min; Cohens d = 0.41), and CUAMI-SF consistency score (FEAST: 69.2 ± 14.2%; RUL-UBP ECT: 63.9 ± 9.9%; Cohens d = 0.43); findings that failed to meet statistical significance.
CONCLUSIONS


FEAST exerts similar efficacy relative to an optimal form of conventional ECT and may have milder cognitive side effects. A blinded, randomized, non-inferiority trial is needed.",2020,"The FEAST group had numeric superiority in average time to reorientation (FEAST: 6.6±5.0 minutes; RUL-UBP ECT: 8.8±5.8 minutes; Cohens d = 0.41), and CUAMI-SF consistency score (FEAST: 69.2±14.2%; RUL-UBP ECT: 63.9±9.9%; Cohens d = 0.43); findings that failed to meet statistical significance.
","['Twenty patients received FEAST (14 women; age 45.2±12.7), and 19 received', '39 depressed adults were recruited after referral for ECT']","['electroconvulsive therapy (ECT', 'FEAST and Right Unilateral Ultrabrief Pulse (RUL-UBP) ECT', 'Focal Electrically-Administered Seizure Therapy (FEAST) and Right Unilateral Ultrabrief Pulse Electroconvulsive Therapy (RUL-UBP ECT', 'RUL-UBP ECT', 'FEAST', 'Focal Electrically-Administered Seizure Therapy (FEAST']","['cognitive side effects', 'CUAMI-SF consistency score', 'efficacy and cognitive side effects', 'postictal time to reorientation and the Columbia University Autobiographical Memory Interview: Short-Form (CUAMI-SF', 'Hamilton Rating Scale for Depression (HRSD 24 ', 'numeric superiority', 'Antidepressant effects', 'HRSD 24  score over time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0451013', 'cui_str': 'Autobiographical memory interview'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",39.0,0.0739028,"The FEAST group had numeric superiority in average time to reorientation (FEAST: 6.6±5.0 minutes; RUL-UBP ECT: 8.8±5.8 minutes; Cohens d = 0.41), and CUAMI-SF consistency score (FEAST: 69.2±14.2%; RUL-UBP ECT: 63.9±9.9%; Cohens d = 0.43); findings that failed to meet statistical significance.
","[{'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Sahlem', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA. Electronic address: sahlem@musc.edu.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'McCall', 'Affiliation': 'Department of Psychiatry and Health Behavior, GA, USA; Medical College of Georgia, GA, USA; Augusta University, GA, USA.'}, {'ForeName': 'E Baron', 'Initials': 'EB', 'LastName': 'Short', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Rosenquist', 'Affiliation': 'Department of Psychiatry and Health Behavior, GA, USA; Medical College of Georgia, GA, USA; Augusta University, GA, USA.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Fox', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA.'}, {'ForeName': 'Nagy A', 'Initials': 'NA', 'LastName': 'Youssef', 'Affiliation': 'Department of Psychiatry and Health Behavior, GA, USA; Medical College of Georgia, GA, USA; Augusta University, GA, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Manett', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Kerns', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA.'}, {'ForeName': 'Morgan M', 'Initials': 'MM', 'LastName': 'Dancy', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA.'}, {'ForeName': 'Laryssa', 'Initials': 'L', 'LastName': 'McCloud', 'Affiliation': 'Department of Psychiatry and Health Behavior, GA, USA; Medical College of Georgia, GA, USA; Augusta University, GA, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'George', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA; Ralph H. Johnson VA Medical Center, SC, USA.'}, {'ForeName': 'Harold A', 'Initials': 'HA', 'LastName': 'Sackeim', 'Affiliation': 'Departments of Psychiatry and Radiology, Columbia University, NY, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.07.015']
1580,32742637,The effectiveness of a contingent financial incentive to improve trial follow up; a randomised study within a trial (SWAT).,"Objectives  To evaluate the effectiveness of a contingent financial incentive (£10 note in addition to a routinely provided £10 voucher) versus no contingent financial incentive, on improving the retention rate in a randomised controlled trial (RCT).  Methods  A two arm 'Study within a Trial' (SWAT) embedded within a host RCT (SCIMITAR+). Participants were randomised to the SWAT using a 2:1 (intervention:control) allocation ratio. The primary outcome measure was the proportion of participants completing a CO breath measurement at the first SCIMITAR+ follow up time point (6 months). Secondary outcomes were withdrawing from follow-up after contact and time from assessment due date to completion.  Analyses were conducted using logistic or Cox Proportional Hazards regression as appropriate.  Results  A total of 434 participants were randomised into this SWAT. Completion of the CO breath measurement at 6 months was 88.5% (n=247) in the intervention arm of the SWAT and 85.4% (n=123) in the control arm (Difference 3.1%, OR 1.29, 95% CI 0.71-2.33, p=0.41). There was also no evidence of a difference in the proportion of participants withdrawing from follow-up after contact (intervention n=7 (2.5%), control n=5 (3.5%); OR 0.76, 95% CI 0.23-2.44, p=0.64), nor in terms of proximity of 6-month visit completion to due date (HR 1.07, 95% CI 0.86-1.33, p=0.55).  Conclusion  It is unclear if contingent financial incentives increased rates of face-to-face follow-up completion within the SCIMITAR+ trial population. However, the sample size of this SWAT was constrained by the size of the host trial and power was limited. This SWAT adds to the body of evidence for initiatives to increase response rates in trials.",2019,Contingent financial incentives did not statistically significantly increase rates of face-to-face follow-up completion within the SCIMITAR+ trial population.,['434 participants'],"['contingent financial incentive', ""Trial' (SWAT) embedded within a host RCT (SCIMITAR""]","['CO breath measurement', 'proportion of participants completing a CO breath measurement', 'withdrawing from follow-up after contact and time from assessment due date to completion']",[],"[{'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2825543', 'cui_str': 'Estimated date of delivery'}]",434.0,0.270546,Contingent financial incentives did not statistically significantly increase rates of face-to-face follow-up completion within the SCIMITAR+ trial population.,"[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Arundel', 'Affiliation': 'Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Coleman', 'Affiliation': 'Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fairhurst', 'Affiliation': 'Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Peckham', 'Affiliation': 'Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Della', 'Initials': 'D', 'LastName': 'Bailey', 'Affiliation': 'Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gilbody', 'Affiliation': 'Department of Health Sciences, University of York, York, YO10 5DD, UK.'}]",F1000Research,['10.12688/f1000research.21059.2']
1581,32743735,FAB: First UK feasibility trial of a future randomised controlled trial of Family focused treatment for Adolescents with Bipolar disorder.,"BACKGROUND


This first mixed-methods UK trial examined the feasibility and acceptability of a future definitive randomised controlled trial (RCT) to evaluate whether Family Focussed Treatment for Adolescents with Bipolar Disorder (FFT-A) UK version can improve family functioning and well-being as part of the management of Paediatric Bipolar Disorder (PBD).
METHOD


The trial used a randomised, parallel group, non-blinded design where participants received FFT-A UK (16 sessions over 6 months) immediately or after 12 months (delayed arm). Measures of family functioning, well-being and quality of life of the young person and the main carer (most commonly a parent) were completed at baseline, 6 and 12-months in both arms. Primary outcome measures included rates of eligibility, consent and retention along with estimates of variability in the measures and assessment of the intervention delivery. Qualitative interviews allowed assessment of participants' views about FFT-A and the trial processes.
RESULTS


Twenty-seven of 36 young persons with PBD and their families consented; of these, 14 families were randomised to the immediate and 13 to the delayed arm. Two families from the immediate arm withdrew consent and discontinued participation. Quantitative measures were completed by 22 families (88%) at 6-months and 21 families (84%) at 12-months. Qualitative interviews were conducted with 30 participants (9 young people, 15 parents and 6 other family members). Nine families attended 3 post-trial focus groups.
CONCLUSION


It was feasible to recruit and retain to this trial. The results highlighted that trial design and measures were acceptable to participants. A benefit in family relationships was reported by participants which they attributed to the intervention in qualitative interviews. Families recommended that future modifications include definitive trial(s) recruiting participants in the age range 15-25 years as it felt this was the age range with maximum need. Trial registration ISRCTN, ISRCTN59769322. Registered 20 January 2014, http://www.isrctn.com/ISRCTN59769322.",2020,"UK version can improve family functioning and well-being as part of the management of Paediatric Bipolar Disorder (PBD).
","['30 participants (9 young people, 15 parents and 6 other family members', 'Adolescents with Bipolar Disorder (FFT-A', 'Twenty-seven of 36 young persons with PBD and their families consented; of these, 14 families', 'Adolescents with Bipolar disorder']","['FAB', 'FFT-A UK']","['rates of eligibility, consent and retention along with estimates of variability in the measures and assessment of the intervention delivery', 'Quantitative measures', 'family functioning, well-being and quality of life of the young person and the main carer']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0021031', 'cui_str': 'Immunoglobulin, F(ab) fragment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}]","[{'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",9.0,0.206574,"UK version can improve family functioning and well-being as part of the management of Paediatric Bipolar Disorder (PBD).
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK. aditya.sharma@ncl.ac.uk.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Glod', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Forster', 'Affiliation': 'Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'McGovern', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'McGurk', 'Affiliation': 'Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Barron Millar', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'T D', 'Initials': 'TD', 'LastName': 'Meyer', 'Affiliation': 'Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center, Houston, TX, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Miklowitz', 'Affiliation': 'Department of Psychiatry, Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Ryan', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vale', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Le Couteur', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}]",International journal of bipolar disorders,['10.1186/s40345-020-00189-y']
1582,32743813,Local prolonged release of antibiotic for prevention of sternal wound infections postcardiac surgery-A novel technology.,"INTRODUCTION


Sternal wound infection (SWI) is a devastating postcardiac surgical complication. D-PLEX 100  (D-PLEX) is a localized prolonged release compound applied as a prophylactic at the completion of surgery to prevent SWI. The D-PLEX technology platform is built as a matrix of alternating layers of polymers and lipids, entrapping an antibiotic (doxycycline). The objective of this study was to assess the safety profile and pharmacokinetics of D-PLEX in reducing SWI rates postcardiac surgery.
METHOD


Eighty-one patients were enrolled in a prospective single-blind randomized controlled multicenter study. Sixty patients were treated with both D-PLEX and standard of care (SOC) and 21 with SOC alone. Both groups were followed 6 months for safety endpoints. SWI was assessed at 90 days.
RESULTS


No SWI-related serious adverse events (SAEs) occurred in either group. The mean plasma C max  in patients treated with D-PLEX was about 10 times lower than the value detected following the oral administration of doxycycline hyclate with an equivalent overall dose, and followed by a very low plasma concentration over the next 30 days. There were no sternal infections in the D-PLEX group (0/60) while there was one patient with a sternal infection in the control group (1/21, 4.8%).
CONCLUSION


D-PLEX was found to be safe for use in cardiac surgery patients. By providing localized prophylactic prolonged release of broad-spectrum antibiotics, D-PLEX has the potential to prevent SWI postcardiac surgery and long-term postoperative hospitalization, reducing high-treatment costs, morbidity, and mortality.",2020,"RESULTS


No SWI-related serious adverse events (SAEs) occurred in either group.","['cardiac surgery patients', 'Eighty-one patients', 'Sixty patients were treated with both D-PLEX and standard of care (SOC) and 21 with SOC alone']","['doxycycline', 'D-PLEX', 'antibiotic (doxycycline']","['sternal infection', 'sternal infections', 'mean plasma C max', 'SWI', 'serious adverse events (SAEs']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",60.0,0.0487843,"RESULTS


No SWI-related serious adverse events (SAEs) occurred in either group.","[{'ForeName': 'Erez', 'Initials': 'E', 'LastName': 'Kachel', 'Affiliation': 'Department of Cardiac Surgery, Poriya Medical Center, Tiberias, Israel.'}, {'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Moshkovitz', 'Affiliation': 'Department of Cardiothoracic Surgery, Assuta Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Sternik', 'Affiliation': 'Department of Cardiac Surgery, Sheba Medical Centre, Tel Hashomer, Israel.'}, {'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'Sahar', 'Affiliation': 'Department of Cardiothoracic Surgery, Soroka Medical Center, Beer Sheva, Israel.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Grosman-Rimon', 'Affiliation': 'Department of Cardiac Surgery, Poriya Medical Center, Tiberias, Israel.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Belotserkovsky', 'Affiliation': 'PolyPid Ltd, Petach-Tikva, Israel.'}, {'ForeName': 'Malka', 'Initials': 'M', 'LastName': 'Reichart', 'Affiliation': 'PolyPid Ltd, Petach-Tikva, Israel.'}, {'ForeName': 'Yafit', 'Initials': 'Y', 'LastName': 'Stark', 'Affiliation': 'PolyPid Ltd, Petach-Tikva, Israel.'}, {'ForeName': 'Noam', 'Initials': 'N', 'LastName': 'Emanuel', 'Affiliation': 'PolyPid Ltd, Petach-Tikva, Israel.'}]",Journal of cardiac surgery,['10.1111/jocs.14890']
1583,32744599,Group-Based vs Individual Pelvic Floor Muscle Training to Treat Urinary Incontinence in Older Women: A Randomized Clinical Trial.,"Importance


Urinary incontinence is one of the most prevalent health concerns experienced by older women (aged ≥60 years). Individual pelvic floor muscle training (PFMT) is the recommended first-line treatment for stress or mixed urinary incontinence in women, but human and financial resources limit its delivery. Whether group-based PFMT performs as well as individual PFMT in this population remains unclear.
Objective


To assess the efficacy of group-based PFMT relative to individual PFMT for urinary incontinence in older women.
Design, Setting, and Participants


The Group Rehabilitation or Individual Physiotherapy (GROUP) study is a single-blind, randomized, noninferiority trial conducted in 2 Canadian research centers, from July 1, 2012, to June 2, 2018. A total of 362 community-dwelling women aged 60 years or older with symptoms of stress or mixed urinary incontinence were enrolled.
Interventions


After an individual session conducted to learn how to contract pelvic floor muscles, participants completed 12-week PFMT as part of a group of 8 women (n = 178) or in individual sessions (n = 184).
Main Outcomes and Measures


The primary outcome measure was the percentage reduction in urinary incontinence episodes at 1 year, as reported in a 7-day bladder diary and relative to pretreatment baseline. Secondary outcomes included lower urinary tract-related signs, symptoms, and quality of life immediately following treatment and at 1 year. Per-protocol analysis was used.
Results


Among 362 women who were randomized (mean [SD] age, 67.9 [5.8] years), 319 women (88%) completed the 1-year follow-up and were included in the per-protocol analysis. Median percentage reduction in urinary incontinence episodes was 70% (95% CI, 44%-89%) in individual PFMT compared with 74% (95% CI, 46%-86%) in group-based PFMT. The upper boundary of the 95% CI for the difference in the percentage reduction in urinary incontinence episodes at 1 year was lower than the prespecified margin for noninferiority of 10% (difference, 4%; 95% CI, -10% to 7%; P = .58), confirming noninferiority. Individual PFMT and group-based PFMT had similar effectiveness for all secondary outcomes at 1 year. Adverse events were minor and uncommon.
Conclusions and Relevance


Results of the GROUP study suggest that group-based PFMT is not inferior to the recommended individual PFMT for the treatment of stress and mixed urinary incontinence in older women. Widespread use in clinical practice may help increase continence-care affordability and treatment availability.
Trial Registration


ClinicalTrials.gov Identifier: NCT02039830.",2020,"Median percentage reduction in urinary incontinence episodes was 70% (95% CI, 44%-89%) in individual PFMT compared with 74% (95% CI, 46%-86%) in group-based PFMT.","['older women', 'Older Women', '362 women who were randomized (mean [SD] age, 67.9 [5.8] years), 319 women (88%) completed the 1-year follow-up and were included in the per-protocol analysis', 'older women (aged ≥60 years', '2 Canadian research centers, from July 1, 2012, to June 2, 2018', '362 community-dwelling women aged 60 years or older with symptoms of stress or mixed urinary incontinence were enrolled']","['Individual pelvic floor muscle training (PFMT', 'Individual Pelvic Floor Muscle Training', 'Group Rehabilitation or Individual Physiotherapy (GROUP', 'Individual PFMT and group-based PFMT', 'group-based PFMT relative to individual PFMT']","['percentage reduction in urinary incontinence episodes at 1 year, as reported in a 7-day bladder diary and relative to pretreatment baseline', 'Adverse events', 'urinary incontinence episodes', 'lower urinary tract-related signs, symptoms, and quality of life']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0869256', 'cui_str': 'Mixed urinary incontinence'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0729866', 'cui_str': 'Lower urinary tract structure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",362.0,0.140746,"Median percentage reduction in urinary incontinence episodes was 70% (95% CI, 44%-89%) in individual PFMT compared with 74% (95% CI, 46%-86%) in group-based PFMT.","[{'ForeName': 'Chantale', 'Initials': 'C', 'LastName': 'Dumoulin', 'Affiliation': 'School of Rehabilitation, Faculty of Medicine, Université de Montréal and Research Center of the Institut Universitaire de Gériatrie de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Morin', 'Affiliation': ""School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Research Center of the Centre Hospitalier de l'Université de Sherbrooke, Sherbrooke, Québec, Canada.""}, {'ForeName': 'Coraline', 'Initials': 'C', 'LastName': 'Danieli', 'Affiliation': 'Research Institute of the McGill University Health Center, Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Québec, Canada.'}, {'ForeName': 'Licia', 'Initials': 'L', 'LastName': 'Cacciari', 'Affiliation': 'School of Rehabilitation, Faculty of Medicine, Université de Montréal and Research Center of the Institut Universitaire de Gériatrie de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Mayrand', 'Affiliation': ""Department of Obstetrics and Gynecology and Social and Preventive Medicine, Université de Montréal, Research Center of the Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Tousignant', 'Affiliation': ""School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Research Center of the Centre Hospitalier de l'Université de Sherbrooke, Sherbrooke, Québec, Canada.""}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Abrahamowicz', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health, McGill University and Research Institute of the McGill University Health Center, Montreal, Québec, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA internal medicine,['10.1001/jamainternmed.2020.2993']
1584,32708511,Lactobacillus paracasei  KW3110 Suppresses Inflammatory Stress-Induced Premature Cellular Senescence of Human Retinal Pigment Epithelium Cells and Reduces Ocular Disorders in Healthy Humans.,"Lactobacillus paracasei  KW3110 (KW3110) has anti-inflammatory effects and mitigates retinal pigment epithelium (RPE) cell damage caused by blue-light exposure. We investigated whether KW3110 suppresses chronic inflammatory stress-induced RPE cell damage by modulating immune cell activity and whether it improves ocular disorders in healthy humans. First, we showed that KW3110 treatment of mouse macrophages (J774A.1) produced significantly higher levels of interleukin-10 as compared with other lactic acid bacterium strains (all  p  < 0.01). Transferring supernatant from KW3110- and  E. coli  0111:B4 strain and adenosine 5'-triphosphate (LPS/ATP)-stimulated J774A.1 cells to human retinal pigment epithelium (ARPE-19) cells suppressed senescence-associated phenotypes, including proliferation arrest, abnormal appearance, cell cycle arrest, and upregulation of cytokines, and also suppressed expression of tight junction molecule claudin-1. A randomized, double-blind, placebo-controlled parallel-group study of healthy subjects ( n  = 88; 35 to below 50 years) ingesting placebo or KW3110-containing supplements for 8 weeks showed that changes in critical flicker frequency, an indicator of eye fatigue, from the week-0 value were significantly larger in the KW3110 group at weeks 4 ( p  = 0.040) and 8 ( p  = 0.036). These results suggest that KW3110 protects ARPE-19 cells against premature senescence and aberrant expression of tight junction molecules caused by chronic inflammatory stress, and may improve chronic eye disorders including eye fatigue.",2020,Lactobacillus paracasei  KW3110 (KW3110) has anti-inflammatory effects and mitigates retinal pigment epithelium (RPE) cell damage caused by blue-light exposure.,"['Healthy Humans', 'healthy humans', 'healthy subjects ( n  = 88; 35 to below 50 years) ingesting']","['placebo or KW3110-containing supplements', 'Lactobacillus paracasei  KW3110 (KW3110', 'KW3110', 'Lactobacillus paracasei  KW3110', 'placebo']","['critical flicker frequency, an indicator of eye fatigue']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1080735', 'cui_str': 'Lactobacillus paracasei'}]","[{'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0004095', 'cui_str': 'Accommodative asthenopia'}]",,0.0862613,Lactobacillus paracasei  KW3110 (KW3110) has anti-inflammatory effects and mitigates retinal pigment epithelium (RPE) cell damage caused by blue-light exposure.,"[{'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Yamazaki', 'Affiliation': 'KIRIN Central Research Institute, Kirin Holdings Co., Ltd., Kanagawa 236-0004, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'KIRIN Central Research Institute, Kirin Holdings Co., Ltd., Kanagawa 236-0004, Japan.'}, {'ForeName': 'Sayuri', 'Initials': 'S', 'LastName': 'Yamada', 'Affiliation': 'KIRIN Central Research Institute, Kirin Holdings Co., Ltd., Kanagawa 236-0004, Japan.'}, {'ForeName': 'Konomi', 'Initials': 'K', 'LastName': 'Ohshio', 'Affiliation': 'KIRIN Central Research Institute, Kirin Holdings Co., Ltd., Kanagawa 236-0004, Japan.'}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Sugamata', 'Affiliation': 'KIRIN Central Research Institute, Kirin Holdings Co., Ltd., Kanagawa 236-0004, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Ario Nishi-Arai Eye Clinic, Tokyo 123-0843, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Morita', 'Affiliation': 'KIRIN Central Research Institute, Kirin Holdings Co., Ltd., Kanagawa 236-0004, Japan.'}]",International journal of molecular sciences,['10.3390/ijms21145091']
1585,32708119,Neurophysiological Correlates of a Single Session of Prefrontal tDCS in Patients with Prolonged Disorders of Consciousness: A Pilot Double-Blind Randomized Controlled Study.,"Background.  Transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex (lDLPFC) was reported to promote the recovery of signs of consciousness in some patients in a minimally conscious state (MCS), but its electrophysiological effects on brain activity remain poorly understood.  Objective.  We aimed to assess behavioral (using the Coma Recovery Scale-Revised; CRS-R) and neurophysiological effects (using high density electroencephalography; hdEEG) of lDLPFC-tDCS in patients with prolonged disorders of consciousness (DOC).  Methods.  In a double-blind, sham-controlled, crossover design, one active and one sham tDCS (2 mA, 20 min) were delivered in a randomized order. Directly before and after tDCS, 10 min of hdEEG were recorded and the CRS-R was administered.  Results.  Thirteen patients with severe brain injury were enrolled in the study. We found higher relative power at the group level after the active tDCS session in the alpha band in central regions and in the theta band over the frontal and posterior regions (uncorrected results). Higher weighted symbolic mutual information (wSMI) connectivity was found between left and right parietal regions, and higher fronto-parietal weighted phase lag index (wPLI) connectivity was found, both in the alpha band (uncorrected results). At the group level, no significant treatment effect was observed. Three patients showed behavioral improvement after the active session and one patient improved after the sham.  Conclusion.  We provide preliminary indications that neurophysiological changes can be observed after a single session of tDCS in patients with prolonged DOC, although they are not necessarily paralleled with significant behavioral improvements.",2020,We found higher relative power at the group level after the active tDCS session in the alpha band in central regions and in the theta band over the frontal and posterior regions (uncorrected results).,"['patients with prolonged disorders of consciousness (DOC', 'Patients with Prolonged Disorders of Consciousness', 'Thirteen patients with severe brain injury']","['Transcranial direct current stimulation (tDCS', 'lDLPFC-tDCS', 'Prefrontal tDCS']","['higher fronto-parietal weighted phase lag index (wPLI) connectivity', 'Higher weighted symbolic mutual information (wSMI) connectivity', 'behavioral improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009792', 'cui_str': 'Consciousness Disorders'}, {'cui': 'C0011710', 'cui_str': 'desoxycorticosterone'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0948775', 'cui_str': 'High weight'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",13.0,0.240879,We found higher relative power at the group level after the active tDCS session in the alpha band in central regions and in the theta band over the frontal and posterior regions (uncorrected results).,"[{'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Carrière', 'Affiliation': 'Brain2 Clinic, Coma Science Group, GIGA Consciousness, University and University Hospital of Liège, 4000 Liège, Belgium.'}, {'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Mortaheb', 'Affiliation': 'Brain2 Clinic, Coma Science Group, GIGA Consciousness, University and University Hospital of Liège, 4000 Liège, Belgium.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Raimondo', 'Affiliation': 'Brain2 Clinic, Coma Science Group, GIGA Consciousness, University and University Hospital of Liège, 4000 Liège, Belgium.'}, {'ForeName': 'Jitka', 'Initials': 'J', 'LastName': 'Annen', 'Affiliation': 'Brain2 Clinic, Coma Science Group, GIGA Consciousness, University and University Hospital of Liège, 4000 Liège, Belgium.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Barra', 'Affiliation': 'Brain2 Clinic, Coma Science Group, GIGA Consciousness, University and University Hospital of Liège, 4000 Liège, Belgium.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Binda Fossati', 'Affiliation': 'Brain2 Clinic, Coma Science Group, GIGA Consciousness, University and University Hospital of Liège, 4000 Liège, Belgium.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Chatelle', 'Affiliation': 'Brain2 Clinic, Coma Science Group, GIGA Consciousness, University and University Hospital of Liège, 4000 Liège, Belgium.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Hermann', 'Affiliation': 'Institut du Cerveau et de la Moelle épinière, ICM, PICNIC Lab, F-75013 Paris, France.'}, {'ForeName': 'Géraldine', 'Initials': 'G', 'LastName': 'Martens', 'Affiliation': 'Brain2 Clinic, Coma Science Group, GIGA Consciousness, University and University Hospital of Liège, 4000 Liège, Belgium.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Di Perri', 'Affiliation': 'Brain2 Clinic, Coma Science Group, GIGA Consciousness, University and University Hospital of Liège, 4000 Liège, Belgium.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Laureys', 'Affiliation': 'Brain2 Clinic, Coma Science Group, GIGA Consciousness, University and University Hospital of Liège, 4000 Liège, Belgium.'}, {'ForeName': 'Aurore', 'Initials': 'A', 'LastName': 'Thibaut', 'Affiliation': 'Brain2 Clinic, Coma Science Group, GIGA Consciousness, University and University Hospital of Liège, 4000 Liège, Belgium.'}]",Brain sciences,['10.3390/brainsci10070469']
1586,32713846,Preferences for different diagnostic modalities to follow up abnormal colorectal cancer screening results: a hypothetical vignette study.,"OBJECTIVES


In England, a significant proportion of people who take part in the national bowel cancer screening programme (BCSP) and have a positive faecal occult blood test (FOBt) result, do not attend follow-up colonoscopy (CC). The aim of this study was to investigate differences in intended participation in a follow-up investigation by diagnostic modality offered including CC, CT colonography (CTC) or capsule endoscopy (CE).
SETTING


We performed a randomised online experiment with individuals who had previously completed an FOBt as part of the English BCSP.
METHODS


Participants (n=953) were randomly allocated to receive one of three online vignettes asking participants to imagine they had received an abnormal FOBt result, and that they had been invited for a follow-up test. The follow-up test offered was either: CC (n=346), CTC (n=302) or CE (n=305). Participants were then asked how likely they were to have their allocated test or if they refused, either of the other tests. Respondents were also asked to cite possible emotional and practical barriers to follow up testing. Multivariable logistic regression models were used to investigate intentions.
RESULTS


Intention to have the test was higher in the CTC group (96.7%) compared with the CC group (91.8%; OR 2.64; 95% CI 1.22 to 5.73). CTC was considered less 'off-putting' (OR 0.66, 95% CI 0.47 to 0.94) and less uncomfortable compared with CC (OR 0.51, 95% CI 0.34 to 0.77). For those who did not intend to have the test they were offered, CE (39.7%) or no investigation (34.5%) was preferable to CC (8.6%) or CTC (17.2%).
CONCLUSIONS


Alternative tests have the potential to increase attendance at diagnostic follow-up appointments.",2020,"RESULTS


Intention to have the test was higher in the CTC group (96.7%) compared with the CC group (91.8%; OR 2.64; 95% CI 1.22 to 5.73).","['Participants (n=953', 'individuals who had previously completed an FOBt as part of the English BCSP']","['online vignettes asking participants to imagine they had received an abnormal FOBt result, and that they had been invited for a follow-up test', 'CC, CT colonography (CTC) or capsule endoscopy (CE']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0201811', 'cui_str': 'Screening for occult blood in feces'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0346627', 'cui_str': 'Malignant tumor of intestine'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0201811', 'cui_str': 'Screening for occult blood in feces'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0935912', 'cui_str': 'Computed Tomographic Colonography'}, {'cui': 'C1721048', 'cui_str': 'Capsule endoscopy'}]",[],953.0,0.0915537,"RESULTS


Intention to have the test was higher in the CTC group (96.7%) compared with the CC group (91.8%; OR 2.64; 95% CI 1.22 to 5.73).","[{'ForeName': 'Aradhna', 'Initials': 'A', 'LastName': 'Kaushal', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Sandro Tiziano', 'Initials': 'ST', 'LastName': 'Stoffel', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kerrison', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'von Wagner', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK c.wagner@ucl.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-035264']
1587,32713847,Evaluation of the teaching recovery techniques community-based intervention for accompanied refugee children experiencing post-traumatic stress symptoms (Accompanied refugeeS In Sweden Trial; ASsIST): study protocol for a cluster randomised controlled trial.,"BACKGROUND


Refugee children have often experienced traumas and are at significant risk of developing mental health problems, such as symptoms of post-traumatic stress disorder (PTSD), depression and anxiety, which can continue for years after resettlement. The Accompanied refugeeS In Sweden Trial (ASsIST) aims to evaluate a community-based intervention, called 'Teaching Recovery Techniques' (TRT), for accompanied refugee minors experiencing PTSD symptoms.
METHODS/DESIGN


A cluster randomised controlled trial will be conducted in which participants will be randomly allocated to one of the two possible arms: the intervention arm (n=113) will be offered the TRT programme and the waitlist-control arm (n=113) will receive services as usual, followed by the TRT programme around 20 weeks later. Outcome data will be collected at three points: pre-intervention (T1), post-intervention (T2; c.8 weeks after randomisation) and follow-up (T3; c.20 weeks after randomisation).
ETHICS AND DISSEMINATION


Ethical approval was granted by the Regional Ethical Review Board in Uppsala (Ref. 2018/382) (24 th  February 2019). Results will be published in scientific journals.
TRIAL REGISTRATION DETAILS


ISRCTN17754931. Prospectively registered on 4 th  June 2019.",2020,"The Accompanied refugeeS In Sweden Trial (ASsIST) aims to evaluate a community-based intervention, called 'Teaching Recovery Techniques' (TRT), for accompanied refugee minors experiencing PTSD symptoms.
","['accompanied refugee children experiencing post-traumatic stress symptoms (Accompanied refugeeS', '2018/382']","['TRT programme and the waitlist-control arm (n=113) will receive services as usual, followed by the TRT programme', 'teaching recovery techniques community-based intervention']",[],"[{'cui': 'C0034961', 'cui_str': 'Refugee'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.230725,"The Accompanied refugeeS In Sweden Trial (ASsIST) aims to evaluate a community-based intervention, called 'Teaching Recovery Techniques' (TRT), for accompanied refugee minors experiencing PTSD symptoms.
","[{'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Warner', 'Affiliation': 'Child Health and Parenting, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden georgina.warner@pubcare.uu.se.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Durbeej', 'Affiliation': 'Child Health and Parenting, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Raziye', 'Initials': 'R', 'LastName': 'Salari', 'Affiliation': 'Child Health and Parenting, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Fängström', 'Affiliation': 'Child Health and Parenting, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Lampa', 'Affiliation': 'Child Health and Parenting, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Zaruhi', 'Initials': 'Z', 'LastName': 'Baghdasaryan', 'Affiliation': 'Child Health and Parenting, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Fatumo', 'Initials': 'F', 'LastName': 'Osman', 'Affiliation': 'Child Health and Parenting, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Gupta Löfving', 'Affiliation': 'Child Health and Parenting, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Perez Aronsson', 'Affiliation': 'Child Health and Parenting, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Feldman', 'Affiliation': 'Child Health and Parenting, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Filipa', 'Initials': 'F', 'LastName': 'Sampaio', 'Affiliation': 'Child Health and Parenting, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ssegonja', 'Affiliation': 'Child Health and Parenting, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bjärtå', 'Affiliation': 'Department of Psychology, Mid Sweden University, Östersund, Sweden.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Rondung', 'Affiliation': 'Department of Psychology, Mid Sweden University, Östersund, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Leiler', 'Affiliation': 'Department of Psychology, Mid Sweden University, Östersund, Sweden.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Wasteson', 'Affiliation': 'Department of Psychology, Mid Sweden University, Östersund, Sweden.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Calam', 'Affiliation': 'Division of Clinical Psychology, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Brit', 'Initials': 'B', 'LastName': 'Oppedal', 'Affiliation': 'Division of Mental Health, Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Brooks', 'Initials': 'B', 'LastName': 'Keeshin', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sarkadi', 'Affiliation': 'Child Health and Parenting, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}]",BMJ open,['10.1136/bmjopen-2019-035459']
1588,32717244,Management of Bladder Bowel Dysfunction in Children by Pelvic Floor Interferential Electrical Stimulation and Muscle Exercises: A Randomized Clinical Trial.,"OBJECTIVE


To assess efficacy of combined pelvic floor interferential (IF) electrical stimulation and muscle exercises on bladder bowel dysfunction (BBD) in children.
MATERIALS AND METHODS


A total of 34 children with BBD (6 boys, 28 girls; mean age 7.4 ± 2.2) were included in this study. Children were evaluated with kidney and bladder ultrasounds, uroflowmetry + electromyography (EMG), and a complete voiding and bowel habit diary before treatment. Exclusion criteria were neuropathic disease, anatomical defects, and mental retardation. Participants were randomly allocated into 2 treatment groups including group A (n = 17) who underwent IF electrical stimulation in addition to pelvic floor muscle (PFM) exercises and group B (n = 17) who received PFM exercises alone. All children were re-evaluated by kidney and bladder ultrasounds, uroflowmetry + EMG and a voiding and bowel habit diary at the end of treatment sessions and 6 months later.
RESULTS


Constipation improved in 14 of 17(82%) and 8 of 17(47%) children in group A and B respectively at the end of treatment sessions (P = .03). Daytime incontinence improved in all children in group A and 2 of 8(25%) children in group B after the treatment (P = .007). Urinary tract infection improved in 8 of 10(80%) and 5 of 13(38.4%) children in group A and B respectively, 6 months after the treatment (P = .02). No significant difference was observed in uroflowmetry measures between 2 groups after the treatment.
CONCLUSION


Combination of IF electrical stimulation and PFM exercises is an effective and safe modality for treatment of BBD in children.",2020,Daytime incontinence improved in all children in group A and 2/8(25%) children in group B after the treatment (P=0.007).,"['34 children with BBD (6 boys, 28 girls; mean age 7.4±2.2', 'children']","['IF electrical stimulation in addition to pelvic floor muscle (PFM) exercises', 'Pelvic Floor Interferential Electrical Stimulation and Muscle Exercises', 'Combination of IF electrical stimulation and PFM exercises', 'PFM exercises alone', 'combined pelvic floor interferential (IF) electrical stimulation and muscle exercises']","['bladder bowel dysfunction (BBD', 'uroflowmetry measures', 'Daytime incontinence', 'Urinary tract infection', 'Constipation', 'kidney and bladder ultrasounds, uroflowmetry\u202f+\u202fEMG and a voiding and bowel habit diary', 'kidney and bladder ultrasounds, uroflowmetry\u202f+\u202felectromyography (EMG), and a complete voiding and bowel habit diary']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0021831', 'cui_str': 'Disorder of intestine'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0021831', 'cui_str': 'Disorder of intestine'}, {'cui': 'C0200008', 'cui_str': 'Uroflowmetry'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0855956', 'cui_str': 'Ultrasound bladder'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",34.0,0.0402003,Daytime incontinence improved in all children in group A and 2/8(25%) children in group B after the treatment (P=0.007).,"[{'ForeName': 'Seyedeh-Sanam', 'Initials': 'SS', 'LastName': 'Ladi-Seyedian', 'Affiliation': ""Pediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Pediatric Center of Excellence, Tehran University of Medical Sciences, Tehran, Iran (IRI).""}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Sharifi-Rad', 'Affiliation': ""Pediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Pediatric Center of Excellence, Tehran University of Medical Sciences, Tehran, Iran (IRI); Department of Physical Therapy, Children's Medical Center, Pediatric Center of Excellence, Tehran University of Medical Sciences, Tehran, Iran (IRI).""}, {'ForeName': 'Abdol-Mohammad', 'Initials': 'AM', 'LastName': 'Kajbafzadeh', 'Affiliation': ""Pediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Pediatric Center of Excellence, Tehran University of Medical Sciences, Tehran, Iran (IRI). Electronic address: kajbafzd@sina.tums.ac.ir.""}]",Urology,['10.1016/j.urology.2020.07.015']
1589,32717273,Effect of high-velocity and traditional resistance exercise on serum antioxidants and inflammation biomarkers in older women: A randomized crossover trial.,"INTRODUCTION


Contrary to the production of oxidant and inflammation biomarkers, antioxidant enzymes decrease with age and the adaptive response to oxidative stress is reduced. The effects of the different resistance exercise protocols to attenuate these conditions are largely unexplored.
OBJECTIVE


We compared the acute effects of traditional resistance exercise (TRE) and high velocity RE (HVRE) on inflammatory biomarkers and antioxidant activity in elderly women.
METHODS


Fourteen elderly women (67 ± 7 years) were randomly assigned to TRE or HVRE. Blood samples were collected to measure inflammatory markers and antioxidant enzymes at three time-points (pre-exercise, post-exercise, 30 min post-exercise).
RESULTS


TRE and HVRE induced acute reductions over time on tumor necrosis factor-alpha, interleukin-6 (IL-6), soluble receptor of IL-6 (sIL-6R), as well in catalase, glutathione and superoxide dismutase antioxidant levels without differences between groups. In addition, TRE and HVRE groups displayed acute increments in interleukin-10 (IL-10) and IL-10/IL-6 ratio over time, while the HVRE protocol displayed higher IL-10 values post-exercise and 30 min post-exercise time points as compared with TRE. Based on magnitude based inference, subjects from the HVRE group demonstrated superior responsiveness for IL-6 and IL-10 as compared with the TRE group. All participants from the HVRE group displayed a minimal clinical important difference on IL-10 levels as compared to only two persons from the TRE group.
CONCLUSION


Both RE protocols were capable of positive changes in inflammatory and antioxidant status in elderly subjects, but HVRE demonstrated a superior response on IL-10. The HVRE may be incorporated to exercise recommendation in this population.",2020,"TRE and HVRE induced acute reductions over time on tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), soluble receptor of IL-6 (sIL-6R), as well in catalase, glutathione (GSH) and superoxide dismutase (SOD) antioxidant levels without differences between groups.","['older women', 'elderly subjects', 'Fourteen elderly women (67\u202f±\u202f7\u202fyears', 'elderly women']","['traditional resistance exercise (TRE) and high velocity RE (HVRE', 'HVRE', 'TRE or HVRE', 'TRE and HVRE', 'High-velocity and traditional resistance exercise']","['superior responsiveness for IL-6 and IL-10', 'inflammatory biomarkers and antioxidant activity', 'Minimal Clinical Important Difference (MCID) on IL-10 levels', 'tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), soluble receptor of IL-6 (sIL-6R), as well in catalase, glutathione (GSH) and superoxide dismutase (SOD) antioxidant levels', 'interleukin-10 (IL-10) and IL-10/IL-6 ratio', 'serum antioxidants and inflammation biomarkers']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0257766', 'cui_str': 'SILV protein, human'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",14.0,0.134689,"TRE and HVRE induced acute reductions over time on tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), soluble receptor of IL-6 (sIL-6R), as well in catalase, glutathione (GSH) and superoxide dismutase (SOD) antioxidant levels without differences between groups.","[{'ForeName': 'Danilo Leandro Santos', 'Initials': 'DLS', 'LastName': 'de Castro', 'Affiliation': 'Department of Physical Education, Catholic University of Brasilia (UCB), Brasilia, Brazil.'}, {'ForeName': 'Dahan', 'Initials': 'D', 'LastName': 'da Cunha Nascimento', 'Affiliation': 'Department of Physical Education, Catholic University of Brasilia (UCB), Brasilia, Brazil; Department of Physical Education, Center University of Distrito Federal (UDF), Brasilia, Brazil; Department of Gerontology, Catholic University of Brasilia, UCB, Brasilia, DF, Brazil.'}, {'ForeName': 'Vânia Silva Macedo', 'Initials': 'VSM', 'LastName': 'Orsano', 'Affiliation': 'Department of Physical Education, Catholic University of Brasilia (UCB), Brasilia, Brazil.'}, {'ForeName': 'Ivo Vieira', 'Initials': 'IV', 'LastName': 'de Sousa Neto', 'Affiliation': 'Laboratory of Molecular Analysis, Graduate Program of Sciences and Technology of Health, University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Fabiani Lage Rodrigues', 'Initials': 'FLR', 'LastName': 'Beal', 'Affiliation': 'Department of Nutrition, Health and Medicine School, Catholic University of Brasilia, UCB, Brasilia, DF, Brazil; Department of Gerontology, Catholic University of Brasilia, UCB, Brasilia, DF, Brazil.'}, {'ForeName': 'Whitley', 'Initials': 'W', 'LastName': 'Stone', 'Affiliation': 'School of Kinesiology Recreation and Sport, Western Kentucky University, Bowling Green, USA.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Dos Santos Rosa', 'Affiliation': 'Department of Physical Education, Catholic University of Brasilia (UCB), Brasilia, Brazil.'}, {'ForeName': 'Jonato', 'Initials': 'J', 'LastName': 'Prestes', 'Affiliation': 'Department of Physical Education, Catholic University of Brasilia (UCB), Brasilia, Brazil. Electronic address: jonatop@gmail.com.'}]",Experimental gerontology,['10.1016/j.exger.2020.111026']
1590,32719129,Randomized trial shows healthcare payment reform has equal-sized spillover effects on patients not targeted by reform.,"Changes in the way health insurers pay healthcare providers may not only directly affect the insurer's patients but may also affect patients covered by other insurers. We provide evidence of such spillovers in the context of a nationwide Medicare bundled payment reform that was implemented in some areas of the country but not in others, via random assignment. We estimate that the payment reform-which targeted traditional Medicare patients-had effects of similar magnitude on the healthcare experience of nontargeted, privately insured Medicare Advantage patients. We discuss the implications of these findings for estimates of the impact of healthcare payment reforms and more generally for the design of healthcare policy.",2020,"We estimate that the payment reform-which targeted traditional Medicare patients-had effects of similar magnitude on the healthcare experience of nontargeted, privately insured Medicare Advantage patients.",[],[],[],[],[],[],,0.0338305,"We estimate that the payment reform-which targeted traditional Medicare patients-had effects of similar magnitude on the healthcare experience of nontargeted, privately insured Medicare Advantage patients.","[{'ForeName': 'Liran', 'Initials': 'L', 'LastName': 'Einav', 'Affiliation': 'Department of Economics, Stanford University, Stanford, CA 94305.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Finkelstein', 'Affiliation': 'National Bureau of Economic Research, Cambridge, MA 02138; afink@mit.edu.'}, {'ForeName': 'Yunan', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'Graduate School of Arts and Sciences, Harvard University, Cambridge, MA 02138.'}, {'ForeName': 'Neale', 'Initials': 'N', 'LastName': 'Mahoney', 'Affiliation': 'Department of Economics, Stanford University, Stanford, CA 94305.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.2004759117']
1591,32719133,Objecting to experiments even while approving of the policies or treatments they compare.,"We resolve a controversy over two competing hypotheses about why people object to randomized experiments: 1) People unsurprisingly object to experiments only when they object to a policy or treatment the experiment contains, or 2) people can paradoxically object to experiments even when they approve of implementing either condition for everyone. Using multiple measures of preference and test criteria in five preregistered within-subjects studies with 1,955 participants, we find that people often disapprove of experiments involving randomization despite approving of the policies or treatments to be tested.",2020,"Using multiple measures of preference and test criteria in five preregistered within-subjects studies with 1,955 participants, we find that people often disapprove of experiments involving randomization despite approving of the policies or treatments to be tested.","['five preregistered within-subjects studies with 1,955 participants']",[],[],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],[],,0.0207082,"Using multiple measures of preference and test criteria in five preregistered within-subjects studies with 1,955 participants, we find that people often disapprove of experiments involving randomization despite approving of the policies or treatments to be tested.","[{'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Heck', 'Affiliation': 'Center for Translational Bioethics and Health Care Policy, Geisinger Health System, Danville, PA 17822; pheck1000@gmail.com.'}, {'ForeName': 'Christopher F', 'Initials': 'CF', 'LastName': 'Chabris', 'Affiliation': 'Autism and Developmental Medicine Institute, Geisinger Health System, Lewisburg, PA 17837.'}, {'ForeName': 'Duncan J', 'Initials': 'DJ', 'LastName': 'Watts', 'Affiliation': 'Annenberg School for Communication, University of Pennsylvania, Philadelphia, PA 19104.'}, {'ForeName': 'Michelle N', 'Initials': 'MN', 'LastName': 'Meyer', 'Affiliation': 'Center for Translational Bioethics and Health Care Policy, Geisinger Health System, Danville, PA 17822.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.2009030117']
1592,32720823,Effect of Low-dose ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Low Dose Trial.,"BACKGROUND


Studies using 1 mg of colchicine to prevent postoperative atrial fibrillation (POAF) reported conflicting results. Moreover, colchicine was associated with significant gastrointestinal (GI) side effects. This study examined whether low-dose colchicine effectively prevents POAF and whether low-dose therapy is associated with lower rates of colchicine-induced GI side effects.
METHODS


In this prospective, randomized, double-blind, placebo-controlled study, consecutive adult patients admitted for elective cardiac surgeries randomly received a 1-mg dose of colchicine (n = 81) or placebo (n = 71) orally 12 to 24 hours before surgery followed by a daily dose of 0.5 mg until hospital discharge. The primary efficacy endpoint was the development of at least one episode of POAF of ≥5 minutes. The primary safety endpoint was the development of adverse events, especially diarrhea.
RESULTS


The in-hospital mortality rate was 3.9%. POAF occurred in 13 patients (16.1%) in the colchicine group and 13 patients (18.3%) in the placebo group (odds ratio 0.85 [95% Confidence Interval = 0.37-1.99]). Diarrhea occurred in two patients in each group and necessitated treatment discontinuation in one patient in each group.
CONCLUSION


Low-dose colchicine did not prevent POAF in patients undergoing cardiac surgery. These results should be interpreted cautiously because of the small sample size and early study termination. ClinicalTrials.gov Unique Identifier number:  NCT03015831.",2020,POAF occurred in 13 patients (16.1%) in the colchicine group and 13 patients (18.3%) in the placebo group (odds ratio 0.85 [95% Confidence Interval = 0.37-1.99]).,"['consecutive adult patients admitted for elective cardiac surgeries', 'Open Heart Surgery Patients', 'patients undergoing cardiac surgery']","['placebo', 'Low-dose ColchiciNe', 'colchicine']","['postoperative atrial fibrillation (POAF', 'significant gastrointestinal (GI) side effects', 'POAF', 'hospital mortality rate', 'InciDence of Atrial Fibrillation', 'development of at least one episode of POAF of ≥5 minutes', 'development of adverse events, especially diarrhea', 'Diarrhea']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",,0.572716,POAF occurred in 13 patients (16.1%) in the colchicine group and 13 patients (18.3%) in the placebo group (odds ratio 0.85 [95% Confidence Interval = 0.37-1.99]).,"[{'ForeName': 'Ramzi A', 'Initials': 'RA', 'LastName': 'Tabbalat', 'Affiliation': 'Abdali Clemenceau Hospital, Amman, Jordan.'}, {'ForeName': 'Imad', 'Initials': 'I', 'LastName': 'Alhaddad', 'Affiliation': 'Jordan Hospital, Amman, Jordan.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Hammoudeh', 'Affiliation': 'Istishari Hospital, Amman, Jordan.'}, {'ForeName': 'Yousef S', 'Initials': 'YS', 'LastName': 'Khader', 'Affiliation': 'Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Hassan Abu', 'Initials': 'HA', 'LastName': 'Khalaf', 'Affiliation': 'Abdali Clemenceau Hospital, Amman, Jordan.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Obaidat', 'Affiliation': 'Abdali Clemenceau Hospital, Amman, Jordan.'}, {'ForeName': 'Jude', 'Initials': 'J', 'LastName': 'Barakat', 'Affiliation': 'Al Khalidi Hospital and Medical Center, Amman, Jordan.'}]",The Journal of international medical research,['10.1177/0300060520939832']
1593,32720831,"Positive effect of care bundles on patients with central venous catheter insertions at a tertiary hospital in Beijing, China.","OBJECTIVE


This study was performed to evaluate the effect of care bundles on the prevention of central venous catheter-related bloodstream infection (CRBSI) and improvement of patients' experience.
METHODS


In total, 212 patients with central venous catheter insertions were enrolled in this study. All patients were matched by sex, age, Acute Physiology and Chronic Health Evaluation II score, body mass index, department, and catheter insertion site and were randomly divided into case and control groups (n = 106 each). The control group was given conventional care, and the case group was given care bundles including nurse education, hand hygiene, maximal sterile barrier precautions, bedside observation, and evaluation. The anxiety scores, hospitalization days, CRBSI rate, and degree of satisfaction with hospitalization were compared between the two groups.
RESULTS


The patients' mean self-rating anxiety scale score and self-rating depression scale score after nursing intervention were significantly lower in the case group than in the control group. The mean number of hospitalization days and CRBSI rate were significantly lower and the satisfaction rate was significantly higher in the case group.
CONCLUSION


Care bundles are essential for preventing CRBSI. They can improve patients' psychological state and hospitalization satisfaction and reduce the hospitalization days.",2020,The patients' mean self-rating anxiety scale score and self-rating depression scale score after nursing intervention were significantly lower in the case group than in the control group.,"['All patients were matched by sex, age, Acute Physiology and Chronic Health Evaluation II score, body mass index, department, and catheter insertion site', ""patients' experience"", 'patients with central venous catheter insertions at a tertiary hospital in Beijing, China', '212 patients with central venous catheter insertions']","['conventional care, and the case group was given care bundles including nurse education, hand hygiene, maximal sterile barrier precautions, bedside observation, and evaluation']","['mean number of hospitalization days and CRBSI rate', 'satisfaction rate', ""patients' psychological state and hospitalization satisfaction"", 'mean self-rating anxiety scale score and self-rating depression scale score', 'anxiety scores, hospitalization days, CRBSI rate, and degree of satisfaction with hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4758051', 'cui_str': 'APACHE II (Acute Physiology and Chronic Health Evaluation II) score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1145640', 'cui_str': 'Central venous catheter'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C3658308', 'cui_str': 'Care Bundles'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2886794', 'cui_str': 'Catheter related bloodstream infection'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",212.0,0.0184669,The patients' mean self-rating anxiety scale score and self-rating depression scale score after nursing intervention were significantly lower in the case group than in the control group.,"[{'ForeName': 'Yuling', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Infectious Diseases, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhongying', 'Initials': 'Z', 'LastName': 'Bao', 'Affiliation': 'Department of Infectious Diseases, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Infectious Diseases, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Department of Infectious Diseases, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.'}]",The Journal of international medical research,['10.1177/0300060520942113']
1594,32720832,"A combination of three probiotic strains for treatment of acute diarrhoea in hospitalised children: an open label, randomised controlled trial.","Acute diarrhoea continues to be a leading cause of morbidity, hospitalisation, and mortality worldwide, and probiotics have been proposed as a complementary therapy in the treatment of acute diarrhoea. The goal of this study is to assess the efficacy and safety of three combined probiotic strains,  Bifidobacterium lactis  Bi-07,  Lactobacillus rhamnosus  HN001, and  Lactobacillus acidophilus  NCFM, as an adjunct to rehydration therapy in treatment of acute watery diarrhoea in hospitalised children. Eligible diarrheal children were randomised into intervention group (IG, n=96, conventional treatment for diarrhoea in combination with probiotics) and control group (CG, n=98, conventional treatment for diarrhoea without probiotics). The primary assessments of this study were duration of diarrhoea and hospital stay and improvement in diarrhoea symptoms. Significantly more children in the IG showed improvements in diarrhoea (defined as a decrease of stool frequency to no more than four times per day and an improved stool consistency within 24-48 h after the treatment) than those in the CG (96.9 vs 79.6%,  P <0.05). Children supplemented with the mixed strains had a 22.5 h shorter (121.4±13.7 h vs 143.9±19.8 h) mean duration of diarrhoea and 1.2 d shorter hospital stays (5.1±1.2 d vs 6.3±1.4 d) than children only receiving the rehydration therapy ( P <0.05). The prevalence of constipation of children in the IG (3.1%) was markedly lower ( P <0.05) than that of children in the CG (13.3%) after treatment. In conclusion, the mixture of three probiotic strains given to children aged 1-3 years resulted in shorter durations of diarrhoea and hospitalisation and a higher percentage of improved children.",2020,"Significantly more children in the IG showed improvements in diarrhoea (defined as a decrease of stool frequency to no more than four times per day and an improved stool consistency within 24-48 h after the treatment) than those in the CG (96.9 vs 79.6%,  P <0.05).","['hospitalised children', 'Eligible diarrheal children']","['probiotic strains', 'conventional treatment for diarrhoea in combination with probiotics) and control group (CG, n=98, conventional treatment for diarrhoea without probiotics']","['stool consistency', 'mean duration of diarrhoea', 'duration of diarrhoea and hospital stay and improvement in diarrhoea symptoms', 'diarrhoea', 'stool frequency', 'efficacy and safety', 'prevalence of constipation of children', 'shorter durations of diarrhoea and hospitalisation', 'hospital stays']","[{'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.0416913,"Significantly more children in the IG showed improvements in diarrhoea (defined as a decrease of stool frequency to no more than four times per day and an improved stool consistency within 24-48 h after the treatment) than those in the CG (96.9 vs 79.6%,  P <0.05).","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': ""Department of Nutrition, Chengdu Women's & Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, No. 1617, Riyue Avenue, Qingyang District, Chengdu, Sichuan 6100131, China P.R.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Xin', 'Affiliation': 'Infinitus (China) Company Ltd., Hangzhou, Zhejiang, China P.R.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': ""Department of Pediatric Intensive Care Unit, Chengdu Women's & Children's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, Sichuan, China P.R.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Department of Pediatrics, Dayi Maternal and Child Health Care Hospital, Chengdu, Sichuan, China P.R.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': 'Department of Pediatrics, Dayi Maternal and Child Health Care Hospital, Chengdu, Sichuan, China P.R.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yuan', 'Affiliation': ""Department of Nutrition, Chengdu Women's & Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, No. 1617, Riyue Avenue, Qingyang District, Chengdu, Sichuan 6100131, China P.R.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Bu', 'Affiliation': 'Department of Pediatrics, Dayi Maternal and Child Health Care Hospital, Chengdu, Sichuan, China P.R.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Pediatrics, Dayi Maternal and Child Health Care Hospital, Chengdu, Sichuan, China P.R.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ge', 'Affiliation': 'Infinitus (China) Company Ltd., Hangzhou, Zhejiang, China P.R.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, 5500 Campanile Dr, San Diego, CA 92182-7251, USA.'}]",Beneficial microbes,['10.3920/BM2020.0046']
1595,32725178,Efficacy of a Psychosocial Pain Management Intervention for Men and Women With Substance Use Disorders and Chronic Pain: A Randomized Clinical Trial.,"Importance


Chronic pain is common in those with substance use disorders (SUDs) and predicts poorer addiction treatment outcomes. A critical challenge for addiction treatment is to develop effective methods to improve pain-related and substance use-related outcomes for those in treatment for SUDs.
Objective


To examine the efficacy of an integrated behavioral pain management intervention (Improving Pain During Addiction Treatment [ImPAT]) for men and women with SUDs to treat pain, functioning, and substance use.
Design, Setting, and Participants


In this randomized clinical trial, 8 sessions of ImPAT were compared with 8 sessions of a supportive psychoeducational control (SPC) condition for adults with pain treated at a large residential SUD treatment program. Follow-up occurred at 3, 6, and 12 months postbaseline. A total of 1372 adults were screened, including 960 men and 412 women, and 510 adults were randomized, including 264 men and 246 women. The goal was to recruit approximately equal numbers of men and women to examine results separately in men and women. A total of 470 of 510 participants (92.2%) completed at least 1 follow-up assessment. Data were collected from October 3, 2011, to January 14, 2016. Data were analyzed from February 1, 2016, to May 1, 2020.
Interventions


ImPAT focused on how a psychosocial model of pain was associated with functioning and relapse prevention and provides skills to manage pain. SPC served as the active control condition and involved discussions of topics like nutrition and the course of addiction, which were intended to be relevant to the patient population and to have face validity but be distinct from the content of ImPAT.
Main Outcomes and Measurements


The primary outcomes were pain intensity, pain-related functioning, and behavioral pain tolerance at 12 months. Secondary outcomes were frequency of alcohol and drug use over 12 months.
Results


Of the 510 included participants, the mean (SD) age was 34.8 (10.3) years. A total of 133 men and 122 women were assigned to ImPAT, and a total of 131 men and 124 women were assigned to the SPC condition. Over 12 months of follow-up, randomization to the ImPAT intervention was associated with higher tolerance of pain among men, higher by a mean score of 0.11 (95% CI, 0.03 to 0.18; P = .004; Cohen d = 0.40) at 3 months and by 0.07 (95% CI, -0.01 to 0.19; P = .11; Cohen d = 0.25) at 12 months. Women receiving the ImPAT intervention experienced a reduction in pain intensity from 3 to 12 months, while women receiving the SPC condition experienced an increase in pain intensity, resulting in lower pain in the ImPAT condition by a mean score of 0.58 (95% CI, -0.07 to 1.22; P = .08; Cohen d = -0.22) at 12 months. No differences were found between the ImPAT and SPC conditions on alcohol or drug use.
Conclusions and Relevance


Behavioral pain management is not typically included in addiction treatment, but the present results indicate that this type of intervention was associated with better pain-related outcomes, including pain tolerance in men and pain intensity in women. Improvements in substance use-related outcomes beyond that achieved by treatment as usual were not observed. Treatment programs should consider providing psychosocial pain management services to augment standard addiction treatment.
Trial Registration


ClinicalTrials.gov Identifier: NCT01372267.",2020,"Over 12 months of follow-up, randomization to the ImPAT intervention was associated with higher tolerance of pain among men, higher by a mean score of 0.11 (95% CI, 0.03 to 0.18; P = .004; Cohen d = 0.40) at 3 months and by 0.07 (95% CI, -0.01 to 0.19; P = .11; Cohen d = 0.25) at 12 months.","['men and women with SUDs to treat pain, functioning, and substance use', 'adults with pain treated at a large residential SUD treatment program', 'men and pain intensity in women', 'A total of 470 of 510 participants (92.2%) completed at least 1 follow-up assessment', 'men and women', '1372 adults were screened, including 960 men and 412 women, and 510 adults were randomized, including 264 men and 246 women', 'A total of 133 men and 122 women were assigned to ImPAT, and a total of 131 men and 124 women', 'Men and Women With Substance Use Disorders and Chronic Pain']","['supportive psychoeducational control (SPC) condition', 'Psychosocial Pain Management Intervention', 'ImPAT intervention', 'integrated behavioral pain management intervention (Improving Pain During Addiction Treatment [ImPAT', 'ImPAT']","['frequency of alcohol and drug use over 12 months', 'ImPAT and SPC conditions on alcohol or drug use', 'pain intensity', 'pain intensity, pain-related functioning, and behavioral pain tolerance', 'lower pain', 'pain tolerance', 'tolerance of pain']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517800', 'cui_str': '510'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517908', 'cui_str': '960'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",1372.0,0.146191,"Over 12 months of follow-up, randomization to the ImPAT intervention was associated with higher tolerance of pain among men, higher by a mean score of 0.11 (95% CI, 0.03 to 0.18; P = .004; Cohen d = 0.40) at 3 months and by 0.07 (95% CI, -0.01 to 0.19; P = .11; Cohen d = 0.25) at 12 months.","[{'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Ilgen', 'Affiliation': 'VA Center for Clinical Management Research (CCMR), Department of Veterans Affairs Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Lara N', 'Initials': 'LN', 'LastName': 'Coughlin', 'Affiliation': 'Department of Psychiatry, University of Michigan Medical School, Ann Arbor.'}, {'ForeName': 'Amy S B', 'Initials': 'ASB', 'LastName': 'Bohnert', 'Affiliation': 'VA Center for Clinical Management Research (CCMR), Department of Veterans Affairs Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Chermack', 'Affiliation': 'VA Center for Clinical Management Research (CCMR), Department of Veterans Affairs Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Price', 'Affiliation': 'VA Center for Clinical Management Research (CCMR), Department of Veterans Affairs Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'H Myra', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'VA Center for Clinical Management Research (CCMR), Department of Veterans Affairs Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Jannausch', 'Affiliation': 'VA Center for Clinical Management Research (CCMR), Department of Veterans Affairs Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Frederic C', 'Initials': 'FC', 'LastName': 'Blow', 'Affiliation': 'VA Center for Clinical Management Research (CCMR), Department of Veterans Affairs Healthcare System, Ann Arbor, Michigan.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.2369']
1596,32728819,Immediate effects of neurodynamic nerve gliding versus static stretching on hamstring neuromechanical properties.,"PURPOSE


We investigated the immediate effects of neurodynamic nerve gliding (ND) on hamstring flexibility, viscoelasticity, and mechanosensitivity, compared with traditional static stretching (ST).
METHODS


Twenty-two physically active men aged 21.9 ± 1.9 years were divided randomly into two equal intervention groups using ST or ND. An isokinetic dynamometer was used to measure the active knee joint position sense, perform passive knee extension, record the passive extension range of motion (ROM) and the passive-resistive torque of hamstrings. Stiffness was determined from the slope of the passive torque-angle relationship. A stress relaxation test (SRT) was performed to analyze the viscoelastic behavior of the hamstrings. The passive straight leg raise (SLR) test was used to evaluate hamstring flexibility.
RESULTS


A significant interaction was observed for ROM and passive ultimate stiffness, reflected by an increase in these indicators after ND but not after SD. SLR increased significantly in both groups. After ST, a significantly faster initial stress relaxation was observed over the first 4 s. than after ND. There was no significant change in the active knee joint position sense.
CONCLUSIONS


ND provided a slightly greater increase in hamstring extensibility and passive stiffness, possibly by decreasing nerve tension and increasing strain in connective tissues than ST. The ST mostly affected the viscoelastic behavior of the hamstrings, but neither intervention had a significant impact on proprioception.",2020,"A significant interaction was observed for ROM and passive ultimate stiffness, reflected by an increase in these indicators after ND but not after SD.",['Twenty-two physically active men aged 21.9\u2009±\u20091.9\xa0years'],"['stress relaxation test (SRT', 'ST or ND', 'neurodynamic nerve gliding versus static stretching', 'traditional static stretching (ST', 'neurodynamic nerve gliding (ND']","['hamstring neuromechanical properties', 'ROM and passive ultimate stiffness', 'SLR', 'hamstring flexibility, viscoelasticity, and mechanosensitivity', 'hamstring extensibility and passive stiffness', 'initial stress relaxation', 'viscoelastic behavior', 'proprioception', 'active knee joint position sense']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0422926', 'cui_str': 'Straight leg raise test response'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0234219', 'cui_str': 'Postural sense'}]",22.0,0.0127856,"A significant interaction was observed for ROM and passive ultimate stiffness, reflected by an increase in these indicators after ND but not after SD.","[{'ForeName': 'Danguole', 'Initials': 'D', 'LastName': 'Satkunskiene', 'Affiliation': 'Institute of Sports Science and Innovation, Lithuanian Sports University, Sporto g. 6, 44221, Kaunas, Lithuania.'}, {'ForeName': ""Ra'ad M"", 'Initials': 'RM', 'LastName': 'Khair', 'Affiliation': 'Institute of Sports Science and Innovation, Lithuanian Sports University, Sporto g. 6, 44221, Kaunas, Lithuania.'}, {'ForeName': 'Pornpimol', 'Initials': 'P', 'LastName': 'Muanjai', 'Affiliation': 'Faculty of Allied Health Sciences, Burapha University, Chonburi, Thailand.'}, {'ForeName': 'Mantas', 'Initials': 'M', 'LastName': 'Mickevicius', 'Affiliation': 'Institute of Sports Science and Innovation, Lithuanian Sports University, Sporto g. 6, 44221, Kaunas, Lithuania. mantas.mickevicius@lsu.lt.'}, {'ForeName': 'Sigitas', 'Initials': 'S', 'LastName': 'Kamandulis', 'Affiliation': 'Institute of Sports Science and Innovation, Lithuanian Sports University, Sporto g. 6, 44221, Kaunas, Lithuania.'}]",European journal of applied physiology,['10.1007/s00421-020-04422-5']
1597,32735021,Platelet-rich Plasma for Androgenetic Alopecia Treatment: A Randomized Placebo-controlled Pilot Study.,"Platelet-rich plasma injections have been presented as an effective treatment for androgenetic alopecia; however, reliable study data concerning this therapy are lacking. The current randomized, placebo-controlled pilot study explored this novel therapy in 30 healthy male subjects with androgenetic alopecia. Five platelet-rich plasma treatments, at intervals of 4-6 weeks, and 2 follow-up examinations were performed. Twenty subjects were injected intracutaneously with platelet-rich plasma and 10 with physiological saline. Treatment efficacy was assessed by changes in hair number and diameter, measured with the TrichoScan system. A secondary objective was to assess clinical improvement, which was evaluated by an independent reviewer using patient photographs and a 5-point Likert scale. In addition, subject satisfaction was assessed by survey. No improvements were seen over the course of the trial, using TrichoScan measurements or visual assessment. In conclusion, these results suggest that treatment with platelet-rich plasma as a monotherapy does not improve hair growth in men with androgenetic alopecia.",2020,"No improvements were seen over the course of the trial, using TrichoScan measurements or visual assessment.","['30 healthy male subjects with androgenetic alopecia', 'Twenty subjects were', 'Androgenetic Alopecia Treatment', 'men with androgenetic alopecia']","['Platelet-rich plasma injections', 'injected intracutaneously with platelet-rich plasma and 10 with physiological saline', 'Placebo', 'placebo']","['TrichoScan measurements or visual assessment', 'hair growth']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0232407', 'cui_str': 'Hair growth'}]",30.0,0.0799981,"No improvements were seen over the course of the trial, using TrichoScan measurements or visual assessment.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gressenberger', 'Affiliation': 'Department of Dermatology, Medical University of Graz, AT-8036 Graz, Austria. paul.gressenberger@medunigraz.at.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Pregartner', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gary', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wolf', 'Affiliation': ''}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Kopera', 'Affiliation': ''}]",Acta dermato-venereologica,['10.2340/00015555-3609']
1598,32730948,An Integrative Clustering Approach to tDCS Individual Response Variability in Cognitive Performance: Beyond a Null Effect on Working Memory.,"Despite the growing interest in the use of transcranial direct current stimulation (tDCS) for the modulation of human cognitive function, there are contradictory findings regarding the cognitive benefits of this technique. Inter-individual response variability to tDCS may play a significant role. We explored the effects of anodal versus sham tDCS over the left prefrontal cortex (LPFC) on working memory performance, taking into account the inter-individual variability. Twenty-nine healthy volunteers received an 'offline' anodal tDCS (1.5 mA, 15 min) to the left prefrontal cortex (F3 electrode site) in an intra-individual, cross-over, sham-controlled experimental design. n-back and Sternberg task performance was assessed before (baseline), immediately after tDCS administration (T1) and 5 min post-T1 (T2). We applied an integrative clustering approach to characterize both the group and individual responses to tDCS, as well as identifying naturally occurring subgroups that may be present within the total sample. Anodal tDCS failed to improve working memory performance in the total sample. Cluster analysis identified a subgroup of 'responders' who significantly improved their performance after anodal (vs. sham) stimulation, although not to a greater extent than the best baseline or sham condition. The proportion of 'responders' ranged from 15% to 59% across task conditions and behavioral outputs. Our findings show a high inter-individual variability of the tDCS response, suggesting that the use of tCDS may not be an effective tool to improve working memory performance in healthy subjects. We propose that the use of clustering methods is more suitable in identifying 'responders' and for evaluating the efficacy of this technique.",2020,"Cluster analysis identified a subgroup of 'responders' who significantly improved their performance after anodal (vs. sham) stimulation, although not to a greater extent than the best baseline or sham condition.","['Twenty-nine healthy volunteers', 'healthy subjects']","['Anodal tDCS', 'transcranial direct current stimulation (tDCS', 'anodal versus sham tDCS', ""offline' anodal tDCS (1.5mA, 15min) to the left prefrontal cortex (F3 electrode site) in an intra-individual, cross-over, sham-controlled experimental design""]","['n-back and Sternberg task performance', 'working memory performance']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",29.0,0.0384338,"Cluster analysis identified a subgroup of 'responders' who significantly improved their performance after anodal (vs. sham) stimulation, although not to a greater extent than the best baseline or sham condition.","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Luque-Casado', 'Affiliation': 'Area of Sport Sciences, Faculty of Sports Sciences and Physical Education, Center for Sport Studies, King Juan Carlos University, Madrid, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Rodríguez-Freiría', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sports Sciences and Physical Education, University of A Coruna, Performance and Health Group, A Coruña, Spain.'}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Fogelson', 'Affiliation': 'Area of Sport Sciences, Faculty of Sports Sciences and Physical Education, Center for Sport Studies, King Juan Carlos University, Madrid, Spain.'}, {'ForeName': 'Eliseo', 'Initials': 'E', 'LastName': 'Iglesias-Soler', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sports Sciences and Physical Education, University of A Coruna, Performance and Health Group, A Coruña, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Fernández-Del-Olmo', 'Affiliation': 'Area of Sport Sciences, Faculty of Sports Sciences and Physical Education, Center for Sport Studies, King Juan Carlos University, Madrid, Spain. Electronic address: miguel.delolmo@urjc.es.'}]",Neuroscience,['10.1016/j.neuroscience.2020.07.036']
1599,32737760,A Comparison of Analgesia After a Thoracoscopic Lung Cancer Operation with a Sustained Epidural Block and a Sustained Paravertebral Block: A Randomized Controlled Study.,"INTRODUCTION


This study aimed to compare the challenge of puncture and catheterization and the effect of postoperative analgesia of ultrasound-guided continuous thoracic paravertebral block and the continuous epidural analgesia in patients receiving thoracoscopic surgery for lung cancer.
METHODS


One-hundred and fifty patients received elective unilateral thoracoscopic surgery for lung cancer and were randomized into three groups; test group 1 (T group), test group 2 (P group), and the control group (E group). Both of the test groups received ultrasound-guided continuous thoracic paravertebral block (TPVB) while the control group received continuous epidural analgesia. After the operation, all the patients in the test groups received the same postoperative analgesia; loading dose 0.5 mg kg -1 , background dose 0.25 mg kg -1  h -1 , patient controlled analgesia (PCA) 0.25 mg kg -1 , and a locking time of 60 min, while the patients in the control group received a loading dose of 5 ml, a background dose of 5 ml h -1 , and a locking time of 20 min. The outcomes of this study were the success rate of the puncture and catheter placement, the blocked segments, numerical rating scale (NRS) scores at rest and during coughing, and the segments with reduced or lost cold and pinpricking sensation.
RESULTS


The success rates of the puncture and catheterization in group T were the highest. Compared with group P, the failure rate of the puncture in group E was lower (p < 0.05), but the success rate of catheterization was higher (p < 0.05). The puncture time in group T was the shortest; there was no difference between group E and group T. The time of catheterization in group P was the longest, this was followed by group T, and was the fastest in group E. The stable time of the block level in group E was shorter than that in groups P and T, but was similar between groups P and T. The block level of all three groups in the 4 h postoperative period was similar (p > 0.05), while the 4 h postoperative levels of groups P and T were reduced significantly (p < 0.05).
CONCLUSION


The continuous analgesia technique of paravertebral space catheterization cannot replace the continuous epidural analgesia in thoracoscopic lung cancer surgery as the latter technique is still considered to be the gold standard.
TRIAL REGISTRATION


China Clinical Trial Registration Center identifier ChiCTR1900020973.",2020,"Compared with group P, the failure rate of the puncture in group E was lower (p < 0.05), but the success rate of catheterization was higher (p < 0.05).","['One-hundred and fifty patients received', 'for lung cancer', 'patients receiving thoracoscopic surgery for lung cancer', 'thoracoscopic lung cancer surgery']","['postoperative analgesia of ultrasound-guided continuous thoracic paravertebral block', 'Thoracoscopic Lung Cancer Operation with a Sustained Epidural Block', 'loading dose of 5\xa0ml, a background dose of 5', 'elective unilateral thoracoscopic surgery', 'paravertebral space catheterization', 'puncture and catheterization', 'ultrasound-guided continuous thoracic paravertebral block (TPVB) while the control group received continuous epidural analgesia']","['failure rate of the puncture', 'puncture time', 'success rates of the puncture and catheterization', 'stable time of the block level', 'block level', 'time of catheterization', 'success rate of the puncture and catheter placement, the blocked segments, numerical rating scale (NRS) scores at rest and during coughing, and the segments with reduced or lost cold and pinpricking sensation', 'success rate of catheterization']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C3714444', 'cui_str': 'Loading dose'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0883301', 'cui_str': 'Catheter placement'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}]",150.0,0.0451201,"Compared with group P, the failure rate of the puncture in group E was lower (p < 0.05), but the success rate of catheterization was higher (p < 0.05).","[{'ForeName': 'Qiao-Wen', 'Initials': 'QW', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou, 363000, China.'}, {'ForeName': 'Jia-Bin', 'Initials': 'JB', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou, 363000, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou, 363000, China.'}, {'ForeName': 'Wen-Qing', 'Initials': 'WQ', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou, 363000, China.'}, {'ForeName': 'Zhi-Wei', 'Initials': 'ZW', 'LastName': 'Lu', 'Affiliation': 'Department of Anesthesiology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou, 363000, China. luzhiwei9366@163.com.'}]",Advances in therapy,['10.1007/s12325-020-01446-3']
1600,32739652,"Extended antiplatelet therapy with clopidogrel alone versus clopidogrel plus aspirin after completion of 9- to 12-month dual antiplatelet therapy for acute coronary syndrome patients with both high bleeding and ischemic risk. Rationale and design of the OPT-BIRISK double-blinded, placebo-controlled randomized trial.","BACKGROUND


Dual antiplatelet therapy with aspirin and a P2Y12 inhibitor is the cornerstone for prevention ischemic events in patients with acute coronary syndromes (ACS) and undergoing percutaneous coronary intervention. However, the optimal antiplatelet strategy for ACS patients with both high bleeding and high ischemic risks is unclear.
STUDY DESIGN


The OPT-BIRISK trial is a multicenter, double-blinded, placebo-controlled randomized study designed to test the superiority of extended antiplatelet therapy with clopidogrel monotherapy compared with aspirin and clopidogrel for reduction of bleeding events in ACS patients with both high bleeding and high ischemic risks (""bi-risk""). A total of 7,700 patients who completed 9- to 12-month dual antiplatelet therapy after new-generation drug-eluting stent implantation for the treatment of ACS will be randomized to receive clopidogrel monotherapy or aspirin plus clopidogrel for 9 months followed by aspirin monotherapy for 3 months. The primary end point is Bleeding Academic Research Consortium type 2, 3, or 5 bleedings at 9 months after randomization. The key secondary end point is major adverse cardiac and cerebral events at 9 months after randomization, defined as a composite of all-cause death, myocardial infarction, stroke, or coronary artery revascularization.
CONCLUSIONS


OPT-BIRISK is the first large-scale randomized trial aimed to explore the optimal antiplatelet strategy for bi-risk ACS patients after percutaneous coronary intervention in current clinical practice. The results will add evidence regarding de-escalation antiplatelet therapy for patients at special risk.",2020,"The primary end point is Bleeding Academic Research Consortium type 2, 3, or 5 bleedings at 9 months after randomization.","['7,700 patients who completed 9- to 12-month dual antiplatelet therapy after new-generation drug-eluting stent implantation for the treatment of ACS', 'patients with acute coronary syndromes (ACS) and undergoing percutaneous coronary intervention', 'acute coronary syndrome patients with both high bleeding and ischemic risk', 'patients at special risk', 'ACS patients with both high bleeding and high ischemic risks (""bi-risk']","['clopidogrel alone versus clopidogrel plus aspirin', 'aspirin and a P2Y12 inhibitor', 'aspirin monotherapy', 'aspirin and clopidogrel', 'clopidogrel monotherapy or aspirin plus clopidogrel', 'placebo']","['major adverse cardiac and cerebral events', 'composite of all-cause death, myocardial infarction, stroke, or coronary artery revascularization', 'bleeding events', 'Bleeding Academic Research Consortium type 2, 3, or 5 bleedings']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205555', 'cui_str': 'Special'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]",7700.0,0.0625651,"The primary end point is Bleeding Academic Research Consortium type 2, 3, or 5 bleedings at 9 months after randomization.","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Quanmin', 'Initials': 'Q', 'LastName': 'Jing', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Xiaozeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Shubing', 'Initials': 'S', 'LastName': 'Qiao', 'Affiliation': 'Fu Wai Hospital of Chinese Academy of Medical Science, Beijing, China.'}, {'ForeName': 'Shaoliang', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Nanjing First Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China. Electronic address: hanyaling@263.net.'}]",American heart journal,['10.1016/j.ahj.2020.07.005']
1601,32739670,"The effects of a transitional care program on discharge readiness, transitional care quality, health services utilization and satisfaction among Chinese kidney transplant recipients: A randomized controlled trial.","BACKGROUND


Kidney transplantation is the major treatment for end-stage renal disease (ESRD). However, kidney transplant recipients (KTRs) face severe challenges during the transition period from hospital discharge to home, increasing the risk of early hospital readmission (EHR) and affecting patient safety. Nevertheless, knowledge of effective transitional care for KTRs is limited in China.
OBJECTIVE


To evaluate the effectiveness of an innovative transitional care program in improving discharge readiness, transitional care quality, health services utilization and patient satisfaction among KTRs in China.
DESIGN


A prospective randomized controlled trial.
SETTINGS AND PARTICIPANTS


Patients admitted to undergo kidney transplantation were recruited in a general tertiary hospital in Chengdu, China.
METHODS


A total of 220 eligible patients were recruited and randomly assigned to the intervention and control groups. Participants in the intervention group received a transitional care intervention developed by the research team, including a risk assessment for early readmission, health education from admission to predischarge, individualized discharge planning, and a telephone follow-up once per week for one month and WeChat follow-up postdischarge. The control group received routine care of comparable length and follow-up contact. A trained research assistant collected all patients' baseline data on admission (T0), evaluated the discharge readiness (by the Readiness for Hospital Discharge Scale) on the day of discharge (T1), collected data on transitional care quality (by the Care Transition Measure-15) and patients' satisfaction with transitional care services (by a self-developed patient satisfaction scale) on the 30th day postdischarge (T2), and collected data on hospital readmission, unscheduled outpatient department visits, and emergency room visits on the 30th and 90th days (by a self-developed health services utilization record table) (T3) postdischarge. Intervention effects were analyzed using independent samples t-tests, Wilcoxon-Mann-Whitney U tests, Chi-square tests or Fisher's exact test.
RESULTS


Compared with the control group, the intervention group showed significantly better discharge readiness (personal status, P<0.001; knowledge, P = 0.010; coping ability, P<0.001; expected support, P = 0.007; total score, P<0.001), better transitional care quality (importance of preferences, P<0.001; management preparation, P<0.001; critical understanding, P = 0.003; written and understandable care plan, P = 0.012; total score, P<0.001), lower readmission rate at T2 (P = 0.033) and at T3 (P = 0.013), lower emergency room visit rate at T3 (P = 0.014), and better satisfaction with transitional care services (P<0.001).
CONCLUSIONS


This study provides evidence that an innovative transitional care program is effective in promoting KTRs' discharge readiness, transitional care quality, reducing hospital readmission and emergency room visits, and improving their satisfaction with transitional care services.
TRIAL REGISTRATION


Clinical Trials ChiCTR1800014971.",2020,"Compared with the control group, the intervention group showed significantly better discharge readiness (personal status, P<0.001; knowledge, P = 0.010; coping ability, P<0.001; expected support, P = 0.007; total score, P<0.001), better transitional care quality (importance of preferences, P<0.001; management preparation, P<0.001; critical understanding, P = 0.003; written and understandable care plan, P = 0.012; total score, P<0.001), lower readmission rate at T2 (P = 0.033) and at T3 (P = 0.013), lower emergency room visit rate at T3 (P = 0.014), and better satisfaction with transitional care services (P<0.001).
","['A total of 220 eligible patients', 'KTRs in China', 'Chinese kidney transplant recipients', 'Patients admitted to undergo kidney transplantation were recruited in a general tertiary hospital in Chengdu, China']","['transitional care program', 'transitional care intervention developed by the research team, including a risk assessment for early readmission, health education from admission to predischarge, individualized discharge planning, and a telephone follow-up once per week for one month and WeChat follow-up postdischarge', 'routine care of comparable length and follow-up contact', 'innovative transitional care program']","['discharge readiness', ""discharge readiness (by the Readiness for Hospital Discharge Scale) on the day of discharge (T1), collected data on transitional care quality (by the Care Transition Measure-15) and patients' satisfaction with transitional care services (by a self-developed patient satisfaction scale) on the 30th day postdischarge (T2), and collected data on hospital readmission, unscheduled outpatient department visits, and emergency room visits on the 30th and 90th days (by a self-developed health services utilization record table) (T3) postdischarge"", 'lower emergency room visit rate', 'lower readmission rate', 'discharge readiness, transitional care quality, health services utilization and satisfaction', 'discharge readiness, transitional care quality, health services utilization and patient satisfaction', 'risk of early hospital readmission (EHR) and affecting patient safety', 'transitional care quality', ""samples t-tests, Wilcoxon-Mann-Whitney U tests, Chi-square tests or Fisher's exact test""]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0012622', 'cui_str': 'Discharge planning'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0242927', 'cui_str': 'Mann-Whitney U Test'}, {'cui': 'C0008041', 'cui_str': 'Chi-Square Test'}, {'cui': 'C0325045', 'cui_str': 'Martes pennanti'}]",220.0,0.0555818,"Compared with the control group, the intervention group showed significantly better discharge readiness (personal status, P<0.001; knowledge, P = 0.010; coping ability, P<0.001; expected support, P = 0.007; total score, P<0.001), better transitional care quality (importance of preferences, P<0.001; management preparation, P<0.001; critical understanding, P = 0.003; written and understandable care plan, P = 0.012; total score, P<0.001), lower readmission rate at T2 (P = 0.033) and at T3 (P = 0.013), lower emergency room visit rate at T3 (P = 0.014), and better satisfaction with transitional care services (P<0.001).
","[{'ForeName': 'Rujun', 'Initials': 'R', 'LastName': 'Hu', 'Affiliation': 'West China School of Nursing/West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China; Emergency Department, Affiliated Hospital of Zunyi Medical University, Zunyi Medical University, Zunyi 563000, Guizhou, China; School of Nursing, Zunyi Medical University, Zunyi 563000, Guizhou, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Gu', 'Affiliation': 'Department of Urology/Institute of Urology/Organ Transplantation Center,West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Qiling', 'Initials': 'Q', 'LastName': 'Tan', 'Affiliation': 'Department of Urology/Institute of Urology/Organ Transplantation Center,West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'KaiZhi', 'Initials': 'K', 'LastName': 'Xiao', 'Affiliation': 'Department of Urology/Institute of Urology/Organ Transplantation Center,West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Urology/Institute of Urology/Organ Transplantation Center,West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Xiaoyi', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Department of Nephrology, Hemodialysis Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Turun', 'Initials': 'T', 'LastName': 'Song', 'Affiliation': 'Department of Urology/Institute of Urology/Organ Transplantation Center,West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Xiaolian', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'West China School of Nursing/West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China. Electronic address: jiangxiaolianhl@163.com.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103700']
1602,32739671,Effects and mediating mechanisms of a structured limbs-exercise program on general cognitive function in older adults with mild cognitive impairment: A randomized controlled trial.,"BACKGROUND


Exercise is known to prevent cognitive decline. Sleep quality and depression symptoms, which are associated with processing speed, are considered as common mediators in the exercise-cognition putative model. However, these mediating mechanisms have not been empirically tested in an intervention study.
OBJECTIVE


The aim of this study was to evaluate the effects of a structured limbs-exercise program on general cognitive function, and to test the mediating effects and mediating pathways of depressive symptoms, sleep quality and processing speed in the relationship of exercise-induced cognitive benefits.
DESIGN


A two-arm and assessor-blinded randomized controlled trial.
SETTINGS AND PARTICIPANTS


Community-dwelling older adults with mild cognitive impairment living in an urban area in Chifeng, China.
METHODS


Participants (N=116) were randomly allocated to one of the two arms: (1) a 24-week structured limbs-exercise program (3 supervised limb exercise sessions /week, 60 min /session for the first 12 weeks and 3 unsupervised practice sessions /week, 60 min /session for the following 12 weeks) or (2) health promotion classes alone. Measures of depressive symptoms, sleep quality, processing speed, and general cognitive function were collected at baseline, 12-week, and 24-week. Multivariate analysis of variance and structural equation modeling was used to test the effectiveness and mechanisms of structured limbs-exercise-induced cognitive improvement respectively.
RESULTS


The structured limbs-exercise program was beneficial for maintaining general cognitive function at 12 weeks (mean difference = 1.20, 95% CI [0.354, 2.054], p = 0.006) and at 24 weeks (mean difference = 1.59, 95% CI [0.722, 2.458], p = 0.001) in the intervention group. The results from the goodness-of-fit indices of structural equation modeling show as following: (1) The effect of structured limbs-exercise program on cognitive function was partially mediated by depressive symptoms, sleep quality, and processing speed, with 69.22% of joint mediation proportion; (2) Relative to the combined Z values of depressive symptoms and processing speed, sleep quality was more strongly related to cognitive function in the structured limbs-exercise program (Z= 9.294, p<0.01); (3) Processing speed was affected by depressive symptoms, sleep quality, and in turn, yielding a significant effect on cognitive function; and (4) Five potential mediating pathways for improvement in general cognitive function in the structured limbs-exercise intervention were identified.
CONCLUSION


This study shows that this exercise program can maintain general cognitive function for older adults with mild cognitive impairment. Mediating variables include depressive symptoms, sleep quality and processing speed. Future research should continue to incorporate path-oriented intervention strategies in the exercise intervention to maximize improvements in cognitive function. Registration number: ChiCTR1800016299.",2020,"The structured limbs-exercise program was beneficial for maintaining general cognitive function at 12 weeks (mean difference = 1.20, 95% CI [0.354, 2.054], p = 0.006) and at 24 weeks (mean difference = 1.59, 95% CI [0.722, 2.458], p = 0.001) in the intervention group.","['Community-dwelling older adults with mild cognitive impairment living in an urban area in Chifeng, China', 'Participants (N=116', 'older adults with mild cognitive impairment']","['exercise program', '24-week structured limbs-exercise program (3 supervised limb exercise sessions /week, 60\xa0min /session for the first 12 weeks and 3 unsupervised practice sessions /week, 60\xa0min /session for the following 12 weeks) or (2) health promotion classes alone', 'structured limbs-exercise program']","['general cognitive function', 'depressive symptoms, sleep quality, and processing speed', 'depressive symptoms, sleep quality', 'depressive symptoms and processing speed, sleep quality', 'cognitive function', 'depressive symptoms, sleep quality, processing speed, and general cognitive function', 'depressive symptoms, sleep quality and processing speed', 'Sleep quality and depression symptoms']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",116.0,0.141098,"The structured limbs-exercise program was beneficial for maintaining general cognitive function at 12 weeks (mean difference = 1.20, 95% CI [0.354, 2.054], p = 0.006) and at 24 weeks (mean difference = 1.59, 95% CI [0.722, 2.458], p = 0.001) in the intervention group.","[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'School of Medicine, Huzhou University, Huzhou Central Hospital, Huzhou, Zhejiang 313000, China. Electronic address: aring2000@163.com.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Rory Meyers College of Nursing, New York University, New York, NY 10010, USA. Electronic address: bei.wu@nyu.edu.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Tao', 'Affiliation': 'AdventHealth Whole-Person Research, Orlando, FL 32804, USA. Electronic address: Hong.Tao@AdventHealth.com.'}, {'ForeName': 'Nannan', 'Initials': 'N', 'LastName': 'Chai', 'Affiliation': 'School of Nursing, Chifeng University, Chifeng, Inner Mongolia 024000, China. Electronic address: 151606873@qq.com.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'School of Medicine, Huzhou University, Huzhou Central Hospital, Huzhou, Zhejiang 313000, China. Electronic address: 17858368692@163.com.'}, {'ForeName': 'Xueting', 'Initials': 'X', 'LastName': 'Zhen', 'Affiliation': 'School of Medicine, Huzhou University, Huzhou Central Hospital, Huzhou, Zhejiang 313000, China. Electronic address: zhenxueting1029@163.com.'}, {'ForeName': 'Xianglian', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'School of Medicine, Huzhou University, Huzhou Central Hospital, Huzhou, Zhejiang 313000, China. Electronic address: 18777119676@163.com.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103706']
1603,32740179,Skin-to-Skin Care Is a Safe and Effective Comfort Measure for Infants Before and After Neonatal Cardiac Surgery.,"OBJECTIVES


To determine the effect of skin-to-skin care on stress, pain, behavioral organization, and physiologic stability of infants with critical congenital heart disease before and after neonatal cardiac surgery.
DESIGN


A baseline response-paired design was used, with infants acting as their own controls before, during, and after skin-to-skin care at two distinct time points: once in the preoperative period (T1) and once in the postoperative period (T2).
SETTING


Cardiac ICU and step-down unit in a large metropolitan freestanding children's hospital.
SUBJECTS


Convenience sample of 30 infants admitted preoperatively for critical congenital heart disease.
INTERVENTIONS


Eligible infants were placed into skin-to-skin care for 1 hour with their biological mothers once each at T1 and T2.
MEASUREMENTS AND MAIN RESULTS


Measurements of stress (salivary cortisol), pain and behavior state (COMFORT scale), and physiologic stability (vital signs) were assessed immediately before skin-to-skin care, 30 minutes into skin-to-skin care, and 30 minutes after skin-to-skin care ended. At both T1 and T2, infant pain scores were significantly decreased (p < 0.0001) and infants moved into a calmer behavior state (p < 0.0001) during skin-to-skin care as compared to baseline. At T1, infants also had significantly reduced heart rate (p = 0.002) and respiratory rate (p < 0.0001) and increased systolic blood pressure (p = 0.033) during skin-to-skin care. At both T1 and T2, infant cortisol remained stable and unchanged from pre-skin-to-skin care to during skin-to-skin care (p = 0.096 and p = 0.356, respectively), and significantly increased from during skin-to-skin care to post-skin-to-skin care (p = 0.001 and p = 0.023, respectively). Exploratory analysis revealed differences in cortisol reactivity for infants with higher baseline cortisol (> 0.3 μg/dL) versus lower (≤ 0.3 μg/dL) prior to skin-to-skin care. Infants with higher baseline cortisol at T2 experienced significantly reduced cortisol during skin-to-skin care (p = 0.025). No significant differences in demographics or baseline variables were found between infants in either group.
CONCLUSIONS


Skin-to-skin care is a low-cost, low-risk intervention that promotes comfort and supports physiologic stability in infants before and after neonatal cardiac surgery.",2020,"At both T1 and T2, infant pain scores were significantly decreased (p < 0.0001) and infants moved into a calmer behavior state (p < 0.0001) during skin-to-skin care as compared to baseline.","['infants before and after neonatal cardiac surgery', 'infants with critical congenital heart disease before and after neonatal cardiac surgery', 'Infants Before and After Neonatal Cardiac Surgery', 'Convenience sample of 30 infants admitted preoperatively for critical congenital heart disease', ""large metropolitan freestanding children's hospital""]","['skin-to-skin care', 'Skin-to-Skin Care']","['stress, pain, behavioral organization, and physiologic stability', 'Measurements of stress (salivary cortisol), pain and behavior state (COMFORT scale), and physiologic stability (vital signs', 'heart rate', 'systolic blood pressure', 'respiratory rate', 'cortisol reactivity', 'infant pain scores']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0150773', 'cui_str': 'Skin care'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",30.0,0.0256545,"At both T1 and T2, infant pain scores were significantly decreased (p < 0.0001) and infants moved into a calmer behavior state (p < 0.0001) during skin-to-skin care as compared to baseline.","[{'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Lisanti', 'Affiliation': ""1Nursing and Clinical Care Services, Children's Hospital of Philadelphia, Philadelphia, PA. 2Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, Philadelphia, PA. 3Cardiac Critical Care Medicine, Children's Hospital of Philadelphia, Philadelphia, PA. 4Clinical Anesthesiology and Critical Care, University of Pennsylvania, Philadelphia, PA. 5Adrenal and Puberty Center, Division of Endocrinology and Diabetes, Children's Hospital of Philadelphia, Philadelphia, PA. 6Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA. 7Laboratory of Innovative & Translational Nursing Research, University of Pennsylvania School of Nursing, Philadelphia, PA. 8Office of Nursing Research, University of Pennsylvania School of Nursing, Philadelphia, PA. 9Biostatistics Analysis Core, Office of Nursing Research, University of Pennsylvania School of Nursing, Philadelphia, PA. 10School of Nursing, University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Abigail C', 'Initials': 'AC', 'LastName': 'Demianczyk', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Costarino', 'Affiliation': ''}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Vogiatzi', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Hoffman', 'Affiliation': ''}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Quinn', 'Affiliation': ''}, {'ForeName': 'Jesse L', 'Initials': 'JL', 'LastName': 'Chittams', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Medoff-Cooper', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002493']
1604,32740180,Investigating the Efficacy of Hydrocolloid Dressing for Preventing Nasotracheal Tube-Related Pressure Injury in the PICU.,"OBJECTIVES


To investigate the efficacy of hydrocolloid dressing in reducing the occurrence rate and severity of nasotracheal tube-related pressure injury.
DESIGN


Randomized controlled trial.
SETTING


A PICU in a tertiary medical center in southern China.
PATIENTS


Pediatric patients received invasive mechanical ventilation via nasotracheal tubes.
INTERVENTIONS


The hydrocolloid dressing was cut into an optimal square size, which should cover the area from the nasal columella to the ala.
MEASUREMENTS AND MAIN RESULTS


Eligible participants were randomly allocated to the control group and the experimental group. The participants in the experimental group received hydrocolloid dressing to protect nasal skin from the beginning of nasotracheal intubation, while the participants in the control group received the current care procedure (without hydrocolloid dressing) unless pressure injuries occurred. The hydrocolloid dressing was changed daily to assess the nasal skin. The pressure injury staging system that was redefined and updated by the National Pressure Ulcer Advisory Panel in 2016 was used. The mean duration of nasotracheal intubation was 150.10 ± 117.09 hours in the experimental group and 161.75 ± 120.72 hours in the control group. Forty-five participants had nasotracheal tube-related pressure injuries in control group, whereas 26 patients had in experimental group (72.6% vs 43.3%; absolute difference, 29.3%, 95% CI, 12.5-46%; p = 0.001). The median survival times of the nasal skin integrity were 95.5 hours in the control group and 219.5 hours in the experimental group (p < 0.001).
CONCLUSIONS


Hydrocolloid dressing can not only reduce the occurrence rate of nasotracheal tube-related pressure injury in the child with long-term nasotracheal intubation but also improve the endurance of the nasal skin significantly.",2020,"The median survival times of the nasal skin integrity were 95.5 hours in the control group and 219.5 hours in the experimental group (p < 0.001).
","['A PICU in a tertiary medical center in southern China', 'Pediatric patients received']","['invasive mechanical ventilation via nasotracheal tubes', 'hydrocolloid dressing', 'current care procedure (without hydrocolloid dressing', 'Hydrocolloid dressing', 'Hydrocolloid Dressing']","['occurrence rate', 'mean duration of nasotracheal intubation', 'nasal skin', 'nasotracheal tube-related pressure injuries', 'median survival times of the nasal skin integrity']","[{'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0122734', 'cui_str': 'Hydrocolloid dressing'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C1286235', 'cui_str': 'Integrity of skin'}]",,0.0311669,"The median survival times of the nasal skin integrity were 95.5 hours in the control group and 219.5 hours in the experimental group (p < 0.001).
","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""1Pediatric Intensive Care Unit, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China. 2Department of Nursing, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Jinlu', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Jine', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Yanxuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002494']
1605,32740321,Minimum effective volume of 0.5% ropivacaine for ultrasound-guided costoclavicular brachial plexus block: A dose finding study.,"BACKGROUND


Costoclavicular brachial plexus block (CC-BPB) is a relatively new regional anaesthetic technique and there are no data on the minimum effective volume 90 (MEV90) of 0.5% ropivacaine required for an ultrasound-guided CC-BPB.
OBJECTIVE


To determine the MEV90 of 0.5% ropivacaine required to produce surgical anaesthesia with an ultrasound-guided CC-BPB.
DESIGN


Prospective up-down sequential allocation study design.
SETTING


University teaching hospital in Hong Kong from March 2016 to December 2017.
PATIENTS


Forty-eight, ASA physical status I to III patients, aged 70 years or less and scheduled for elective forearm or hand surgery under an ultrasound-guided CC-BPB, were recruited.
INTERVENTION


Ultrasound-guided CC-BPB was performed with the assigned volume of 0.5% ropivacaine. The Dixon 'up-and-down' sequential allocation method using the biased coin design was used to determine the MEV90 of 0.5% ropivacaine. The assigned volume of ropivacaine was based on the outcome of the previous patient. After a block failure the next patient received a volume increase of 2 ml. If the block was a success, the next patient was allocated, with a probability of b = 0.11, to receive 2 ml less, or, with a probability of 1 - b = 0.89, the same volume.
MAIN OUTCOME MEASURES


A successful block was defined as a minimum score of 14 of 16 points, using a composite sensory and motor block score at 45 min after the injection. The study was stopped when 45 successful blocks were achieved. MEV90 with 95% confidence interval was calculated using the centred isotonic regression for point and interval dose response studies.
RESULTS


The MEV90 of 0.5% ropivacaine for ultrasound-guided CC-BPB was 20.9 (95% confidence interval, 20.7 to 21.8) ml. The mean ± SD time to readiness for surgery was 31.4 ± 12.60 min.
CONCLUSION


The MEV90 of 0.5% ropivacaine required to produce surgical anaesthesia with an ultrasound-guided CC-BPB is 20.9 ml.
CLINICAL TRIAL REGISTRATION


The trial was registered with the Chinese Clinical Trials Registry (www.chictr.org.cn, ChiCTR-IOR-15007515, principal investigator: Manoj Kumar Karmakar, date of registration: 4 December 2015).
CLINICAL TRIAL NUMBER AND REGISTRY URL


ChiCTR-IOR-15007515, Chinese Clinical Trials Registry (www.chictr.org.cn).",2020,"The MEV90 of 0.5% w/v ropivacaine required to produce surgical anaesthesia with an ultrasound-guided CC-BPB is 20.9 ml.
","['III patients, aged 70 years or less and scheduled for elective forearm or hand surgery under an ultrasound-guided CC-BPB, were recruited', 'University teaching hospital in Hong Kong from March 2016 to December 2017', 'Forty-eight, ASA physical status']","['ropivacaine', 'Costoclavicular brachial plexus block (CC-BPB']",['mean\u200a±\u200aSD time to readiness'],"[{'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0187067', 'cui_str': 'Operative procedure on hand'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1608675', 'cui_str': '4-iodo-N-(4-(4-(2-methoxyphenyl)-piperazin-1-yl)butyl)-benzamide'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}, {'cui': 'C1608675', 'cui_str': '4-iodo-N-(4-(4-(2-methoxyphenyl)-piperazin-1-yl)butyl)-benzamide'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}]",45.0,0.0788485,"The MEV90 of 0.5% w/v ropivacaine required to produce surgical anaesthesia with an ultrasound-guided CC-BPB is 20.9 ml.
","[{'ForeName': 'Ming H', 'Initials': 'MH', 'LastName': 'Wong', 'Affiliation': 'From the Department of Anaesthesia & Intensive Care, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, New Territories, Hong Kong, China (MHW, MKK, LYHM, BS, WS).'}, {'ForeName': 'Manoj K', 'Initials': 'MK', 'LastName': 'Karmakar', 'Affiliation': ''}, {'ForeName': 'Louis Y H', 'Initials': 'LYH', 'LastName': 'Mok', 'Affiliation': ''}, {'ForeName': 'Banchobporn', 'Initials': 'B', 'LastName': 'Songthamwat', 'Affiliation': ''}, {'ForeName': 'Winnie', 'Initials': 'W', 'LastName': 'Samy', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001287']
1606,32741240,A social dancing pilot intervention for older adults at high risk for Alzheimer's disease and related dementias.,"Close to 6 million older US adults have Alzheimer's disease or related dementias, yet there is currently no cure or effective treatment. This single-blind randomized controlled trial (clinicaltrials.gov: NCT03475316) aims to establish feasibility, and explore the relative efficacy, of a 6-month social ballroom dancing intervention versus a 6-month active control intervention (treadmill walking) for improving executive function in 32 older adults at increased risk for Alzheimer's disease or related dementias. Dementia-at-risk status is determined with cut-scores on the memory impairment screen (≥3 to ≤6) and/or the AD8 Dementia Screening Interview (≥1). The primary outcome is a composite executive function score from digit-symbol substitution, flanker interference and walking-while-talking tasks. The secondary outcome is functional neuroplasticity during fMRI-adapted versions of digit-symbol substitution, flanker interference and walking-while-talking.",2020,"Close to 6 million older US adults have Alzheimer's disease or related dementias, yet there is currently no cure or effective treatment.","[""older adults at high risk for Alzheimer's disease and related dementias"", ""32 older adults at increased risk for Alzheimer's disease or related dementias""]","['active control intervention (treadmill\xa0walking', 'social ballroom dancing intervention']","['composite executive function score from digit-symbol substitution, flanker interference and walking-while-talking tasks', 'functional neuroplasticity during fMRI-adapted versions of digit-symbol substitution, flanker interference and walking-while-talking']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0027880', 'cui_str': 'Plasticity, Neuronal'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",32.0,0.104066,"Close to 6 million older US adults have Alzheimer's disease or related dementias, yet there is currently no cure or effective treatment.","[{'ForeName': 'Helena M', 'Initials': 'HM', 'LastName': 'Blumen', 'Affiliation': 'Department of Medicine, Albert Einstein College of Medicine, Bronx, NY\xa010461, USA.'}, {'ForeName': 'Emmeline', 'Initials': 'E', 'LastName': 'Ayers', 'Affiliation': 'Department of Neurology, Albert Einstein College of Medicine, Bronx, NY\xa010461, USA.'}, {'ForeName': 'Cuiling', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Albert Einstein College of Medicine, Bronx, NY\xa010461, USA.'}, {'ForeName': 'Anne F', 'Initials': 'AF', 'LastName': 'Ambrose', 'Affiliation': 'Department of Rehabilitation Medicine, Albert Einstein College of Medicine, Bronx, NY\xa010461, USA.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Verghese', 'Affiliation': 'Department of Medicine, Albert Einstein College of Medicine, Bronx, NY\xa010461, USA.'}]",Neurodegenerative disease management,['10.2217/nmt-2020-0002']
1607,32747213,"Efficacy and safety of a live attenuated influenza vaccine in Chinese healthy children aged 3-17 years in one study center of a randomized, double-blind, placebo-controlled phase 3 clinical trial, 2016/17 season.","BACKGROUND


No data on the safety and efficacy of a live attenuated influenza vaccine in China have ever been reported.
METHODS


At a site of a phase 3 randomized, double-blind, placebo-controlled clinical trial in eastern China, eligible healthy children aged 3-17 years underwent randomization to receive live attenuated vaccine or placebo at a ratio of 1:1. The primary objective of the study was the prevention of laboratory-confirmed influenza illness during the surveillance period, starting on day 15 after vaccination.
RESULTS


A total of 2000 participants were enrolled, with 998 receiving the vaccine and 1001 receiving placebo. Sixty-four cases of influenza-like illness were observed, of which, 44 were laboratory-confirmed (12 in vaccine group versus 32 in placebo group). Vaccine efficacy was 62.5% (95%CI: 27.6-80.6) against all types of influenza and 63.3% (95%CI: 27.5-81.5) against influenza H3N2 illness. 11 severe adverse events reported (7 in LAIV group versus 4 in placebo group) were all deemed to be non-vaccine-related. Adverse events occurred in 412 (41.3%) participants in the vaccine group versus 389 (38.9%; p = 0.274) participants in the placebo group. Significant increase incidence of fever was observed in participants in the vaccine group, especially in those aged 3-9 years.
CONCLUSIONS


The live attenuated influenza vaccine showed good efficacy and safety among 3- to 17-year-olds children during the 2016-2017 season at a site in eastern China. Clinical Trial Registry Number: NCT02964065.",2020,Vaccine efficacy was 62.5% (95%CI: 27.6-80.6) against all types of influenza and 63.3% (95%CI: 27.5-81.5) against influenza H3N2 illness.,"['17-year-olds children during the 2016-2017 season at a site in eastern China', 'eastern China, eligible healthy children aged 3-17\xa0years underwent randomization to receive', 'Chinese healthy children aged 3-17\xa0years', '2000 participants were enrolled, with 998 receiving the vaccine and 1001 receiving']","['placebo', 'live attenuated vaccine or placebo', 'live attenuated influenza vaccine']","['11 severe adverse events', 'Adverse events', 'Vaccine efficacy', 'Efficacy and safety', 'efficacy and safety', 'incidence of fever']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3652556', 'cui_str': 'influenza, live attenuated'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]",2000.0,0.738288,Vaccine efficacy was 62.5% (95%CI: 27.6-80.6) against all types of influenza and 63.3% (95%CI: 27.5-81.5) against influenza H3N2 illness.,"[{'ForeName': 'Shenyu', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou 310051, Zhejiang Province, China. Electronic address: sywang@cdc.zj.cn.'}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""Chun'an County Center for Disease Control and Prevention, Hangzhou 311700, Zhejiang Province, China. Electronic address: 411035637@qq.com.""}, {'ForeName': 'Xiongyuan', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': 'Changchun BCHT Biotechnology Co., Changchun 130012, Jilin Province, China. Electronic address: jinxiongyuan@bchtpharm.com.'}, {'ForeName': 'Zhengkai', 'Initials': 'Z', 'LastName': 'Gan', 'Affiliation': 'Xiuzhou District Center for Disease Control and Prevention, Jiaxing 314031, Zhejiang Province, China; Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou 310051, Zhejiang Province, China. Electronic address: ganzhengkai@163.com.'}, {'ForeName': 'Yanzhi', 'Initials': 'Y', 'LastName': 'Shao', 'Affiliation': ""Chun'an County Center for Disease Control and Prevention, Hangzhou 311700, Zhejiang Province, China. Electronic address: 39630267@qq.com.""}, {'ForeName': 'Changlin', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Changchun BCHT Biotechnology Co., Changchun 130012, Jilin Province, China. Electronic address: zhuchanglin@bchtpharm.com.'}, {'ForeName': 'Xiaosong', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou 310051, Zhejiang Province, China. Electronic address: xshu@cdc.zj.cn.'}, {'ForeName': 'Zhenzhen', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou 310051, Zhejiang Province, China. Electronic address: zzliang@cdc.zj.cn.'}, {'ForeName': 'Yingping', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou 310051, Zhejiang Province, China. Electronic address: yingpchen@cdc.zj.cn.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xing', 'Affiliation': 'Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou 310051, Zhejiang Province, China. Electronic address: bxing@cdc.zj.cn.'}, {'ForeName': 'Huakun', 'Initials': 'H', 'LastName': 'Lv', 'Affiliation': 'Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou 310051, Zhejiang Province, China. Electronic address: hklv@cdc.zj.cn.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Changchun BCHT Biotechnology Co., Changchun 130012, Jilin Province, China. Electronic address: xuna@bchtpharm.com.'}]",Vaccine,['10.1016/j.vaccine.2020.07.019']
1608,32749468,Effectiveness of Emotional Memory Reactivation vs Control Memory Reactivation Before Electroconvulsive Therapy in Adult Patients With Depressive Disorder: A Randomized Clinical Trial.,"Importance


Although electroconvulsive therapy (ECT) is often effective, approximately half of patients with depression undergoing ECT do not benefit sufficiently, and relapse rates are high. ECT sessions have been shown to weaken reactivated memories. The effect of emotional memory retrieval on cognitive schemas remains unknown.
Objective


To assess whether emotional memory retrieval just before patients receive ECT sessions weakens underlying cognitive schemas, improves ECT effectiveness, increases ECT response, and reduces relapse rates.
Design, Setting, and Participants


In this multicenter randomized clinical trial conducted from 2014 to 2018 in the departments of psychiatry in 3 hospitals in the Netherlands, 72 participants were randomized 1:1 to 2 parallel groups to receive either emotional memory reactivation (EMR-ECT) or control memory reactivation (CMR-ECT) interventions before ECT sessions. The Hamilton Depression Rating Scale (HDRS [total score range: 0-52, with 0-7 indicating no depression and ≥24 indicating severe depression]) was used to measure symptoms of depression during and after ECT, with a 6-month follow-up period. Participants were between ages 18 and 70 years with a primary diagnosis of unipolar major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition, Text Revision) and in whom ECT was indicated. Data analysis was performed from July to November 2019.
Interventions


EMR-ECT or CMR-ECT interventions prior to ECT sessions.
Main Outcomes and Measures


Depression scores and relapse rates within 6 months were assessed with the HDRS and analyzed using logistic and linear multiple regression analyses.
Results


A total of 66 patients (mean [SD] age, 49.3 [12.3] years; 39 [59.1%] women) were randomized to the EMR-ECT group (n = 32) or the CMR-ECT group (n = 34). Regardless of the memory intervention, 42.4% (28 of 66) of patients responded (≥50% decrease of symptom severity on the HDRS). Of patients who responded, 39.3% (11 of 28) relapsed within 6 months. Remission rates (CMR-ECT group, 29.4% [10 of 34] vs EMR-ECT group, 25.0% [8 of 32]; P = .58), mean (SD) HDRS scores after the ECT course (CMR-ECT group, 14.6 [8.6] vs EMR-ECT group, 14.9 [8.8]; P = .88), total mean (SD) number of required ECT sessions for response (CMR-ECT group, 14.9 [7.9] vs EMR-ECT group, 15.6 [7.3]; P = .39), and relapse rates (CMR-ECT group, 46.7% [7 of 15] vs EMR-ECT group, 30.8% [4 of 13]; P = .33) were not significantly altered by the intervention.
Conclusions and Relevance


Study findings suggest that the EMR-ECT intervention just before patient receipt of ECT for depression did not improve effectiveness, increase speed of response, or reduce relapse rates after the ECT course compared with patients receiving CMR-ECT.
Trial Registration


Trialregister.nl Identifier: NL4289.",2020,"Regardless of the memory intervention, 42.4% (28 of 66) of patients responded (≥50% decrease of symptom severity on the HDRS).","['Participants were between ages 18 and 70 years with a primary diagnosis of unipolar major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders', '2014 to 2018 in the departments of psychiatry in 3 hospitals in the Netherlands, 72 participants', 'Adult Patients With Depressive Disorder', '66 patients (mean [SD] age, 49.3 [12.3] years; 39 [59.1%] women']","['Emotional Memory Reactivation vs Control Memory Reactivation', 'electroconvulsive therapy (ECT', 'EMR-ECT', 'CMR-ECT', 'ECT sessions', 'emotional memory retrieval', 'Electroconvulsive Therapy', 'EMR-ECT intervention', 'emotional memory reactivation (EMR-ECT) or control memory reactivation (CMR-ECT) interventions before ECT sessions', 'EMR-ECT or CMR-ECT interventions']","['total mean (SD) number of required ECT sessions for response', 'ECT effectiveness, increases ECT response', 'relapse rates', 'Hamilton Depression Rating Scale (HDRS [total score range', 'mean (SD) HDRS scores', 'speed of response, or reduce relapse rates', 'Remission rates', 'Measures\n\n\nDepression scores and relapse rates']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0443340', 'cui_str': 'Unipolar'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C5191283', 'cui_str': '12.3'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0006802', 'cui_str': 'Cameroon'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",72.0,0.0967269,"Regardless of the memory intervention, 42.4% (28 of 66) of patients responded (≥50% decrease of symptom severity on the HDRS).","[{'ForeName': 'Dominique S', 'Initials': 'DS', 'LastName': 'Scheepens', 'Affiliation': 'Department of Psychiatry, Amsterdam Neuroscience, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Jeroen A', 'Initials': 'JA', 'LastName': 'van Waarde', 'Affiliation': 'Department of Psychiatry, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Freek', 'Initials': 'F', 'LastName': 'Ten Doesschate', 'Affiliation': 'Department of Psychiatry, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Westra', 'Affiliation': 'Department of Psychiatry, UMC Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Marijn C W', 'Initials': 'MCW', 'LastName': 'Kroes', 'Affiliation': 'Donders Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Aart H', 'Initials': 'AH', 'LastName': 'Schene', 'Affiliation': 'Donders Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Claudi L H', 'Initials': 'CLH', 'LastName': 'Bockting', 'Affiliation': 'Department of Psychiatry, Amsterdam Neuroscience, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Schoevers', 'Affiliation': 'Department of Psychiatry, UMC Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Damiaan A J P', 'Initials': 'DAJP', 'LastName': 'Denys', 'Affiliation': 'Department of Psychiatry, Amsterdam Neuroscience, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Henricus G', 'Initials': 'HG', 'LastName': 'Ruhé', 'Affiliation': 'Donders Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Guido A', 'Initials': 'GA', 'LastName': 'van Wingen', 'Affiliation': 'Department of Psychiatry, Amsterdam Neuroscience, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.12389']
1609,32749474,Correction to Data in Trial of Convalescent Plasma Treatment for COVID-19.,,2020,,[],[],[],[],[],[],,0.0321843,,[],JAMA,['10.1001/jama.2020.13216']
1610,32749491,Effect of Long-term Vitamin D3 Supplementation vs Placebo on Risk of Depression or Clinically Relevant Depressive Symptoms and on Change in Mood Scores: A Randomized Clinical Trial.,"Importance


Low levels of 25-hydroxyvitamin D have been associated with higher risk for depression later in life, but there have been few long-term, high-dose large-scale trials.
Objective


To test the effects of vitamin D3 supplementation on late-life depression risk and mood scores.
Design, Setting, and Participants


There were 18 353 men and women aged 50 years or older in the VITAL-DEP (Vitamin D and Omega-3 Trial-Depression Endpoint Prevention) ancillary study to VITAL, a randomized clinical trial of cardiovascular disease and cancer prevention among 25 871 adults in the US. There were 16 657 at risk for incident depression (ie, no depression history) and 1696 at risk for recurrent depression (ie, depression history but no treatment for depression within the past 2 years). Randomization occurred from November 2011 through March 2014; randomized treatment ended on December 31, 2017, and this was the final date of follow-up.
Intervention


Randomized assignment in a 2 × 2 factorial design to vitamin D3 (2000 IU/d of cholecalciferol) and fish oil or placebo; 9181 were randomized to vitamin D3 and 9172 were randomized to matching placebo.
Main Outcomes and Measures


The primary outcomes were the risk of depression or clinically relevant depressive symptoms (total of incident and recurrent cases) and the mean difference in mood scores (8-item Patient Health Questionnaire depression scale [PHQ-8]; score range, 0 points [least symptoms] to 24 points [most symptoms]; the minimal clinically important difference for change in scores was 0.5 points).
Results


Among the 18 353 randomized participants (mean age, 67.5 [SD, 7.1] years; 49.2% women), the median treatment duration was 5.3 years and 90.5% completed the trial (93.5% among those alive at the end of the trial). Risk of depression or clinically relevant depressive symptoms was not significantly different between the vitamin D3 group (609 depression or clinically relevant depressive symptom events; 12.9/1000 person-years) and the placebo group (625 depression or clinically relevant depressive symptom events; 13.3/1000 person-years) (hazard ratio, 0.97 [95% CI, 0.87 to 1.09]; P = .62); there were no significant differences between groups in depression incidence or recurrence. No significant differences were observed between treatment groups for change in mood scores over time; mean change in PHQ-8 score was not significantly different from zero (mean difference for change in mood scores, 0.01 points [95% CI, -0.04 to 0.05 points]).
Conclusions and Relevance


Among adults aged 50 years or older without clinically relevant depressive symptoms at baseline, treatment with vitamin D3 compared with placebo did not result in a statistically significant difference in the incidence and recurrence of depression or clinically relevant depressive symptoms or for change in mood scores over a median follow-up of 5.3 years. These findings do not support the use of vitamin D3 in adults to prevent depression.
Trial Registration


ClinicalTrials.gov Identifiers: NCT01169259 and NCT01696435.",2020,"No significant differences were observed between treatment groups for change in mood scores over time; mean change in PHQ-8 score was not significantly different from zero (mean difference for change in mood scores, 0.01 points [95% CI, -0.04 to 0.05 points]).
","['Among the 18\u202f353 randomized participants (mean age, 67.5 [SD, 7.1] years; 49.2% women', 'Participants\n\n\nThere were 18\u202f353 men and women aged 50 years or older in the VITAL-DEP (Vitamin D and Omega-3 Trial-Depression Endpoint Prevention) ancillary study to VITAL, a randomized clinical trial of cardiovascular disease and cancer prevention among 25\u202f871 adults in the US', 'adults aged 50 years or older without clinically', 'There were 16\u202f657 at risk for incident depression (ie, no depression history) and 1696 at risk for recurrent depression (ie, depression history but no treatment for depression within the past 2 years']","['Long-term Vitamin D3 Supplementation vs Placebo', '25-hydroxyvitamin D', 'vitamin D3 supplementation', 'vitamin D3 (2000 IU/d of cholecalciferol) and fish oil or placebo', 'vitamin D3', 'placebo']","['relevant depressive symptoms', 'late-life depression risk and mood scores', 'Risk of depression or clinically relevant depressive symptoms', 'depression incidence or recurrence', 'Risk of Depression or Clinically Relevant Depressive Symptoms', 'mood scores', 'risk of depression or clinically relevant depressive symptoms (total of incident and recurrent cases) and the mean difference in mood scores (8-item Patient Health Questionnaire depression scale [PHQ-8]; score range, 0 points [least symptoms', 'median treatment duration', 'Mood Scores', 'incidence and recurrence of depression or clinically relevant depressive symptoms', 'PHQ-8 score']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0057472', 'cui_str': '1-(2-(dodecyloxy)ethyl)pyrrolidine hydrochloride'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0221480', 'cui_str': 'Recurrent depression'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444637', 'cui_str': 'Past'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}]",25871.0,0.741621,"No significant differences were observed between treatment groups for change in mood scores over time; mean change in PHQ-8 score was not significantly different from zero (mean difference for change in mood scores, 0.01 points [95% CI, -0.04 to 0.05 points]).
","[{'ForeName': 'Olivia I', 'Initials': 'OI', 'LastName': 'Okereke', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Reynolds', 'Affiliation': 'Department of Psychiatry, UPMC and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mischoulon', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, VA Boston Healthcare System, Brockton, Massachusetts.'}, {'ForeName': 'Chirag M', 'Initials': 'CM', 'LastName': 'Vyas', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston.'}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': 'Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Weinberg', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Bubes', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Copeland', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Friedenberg', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': 'Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': 'Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}]",JAMA,['10.1001/jama.2020.10224']
1611,32745732,Smartphone-based application to improve medication adherence in patients after surgical coronary revascularization.,"BACKGROUND


Secondary preventive therapies play a key role in the prevention of adverse events after coronary artery bypass grafting (CABG). However, adherence to secondary preventive drugs after CABG is often poor. With the increasing penetration of smartphones, health-related smartphone applications might provide an opportunity to improve medication adherence. We aimed to evaluate the effectiveness and feasibility of using a smartphone-based application to improve medication adherence in patients after CABG.
METHODS


The Measurement and Improvement Studies of Surgical coronary revascularizatION: medication adherence (MISSION-2) study is a multicenter randomized controlled trial that planned to enroll over 1000 patients who underwent isolated CABG at one of four large teaching hospitals in China; all enrolled participants had access to a smartphone and were able to operate at least three smartphone applications. The investigators randomly assigned the participants to one of two groups: (1) the intervention group with an advanced smartphone application for 6 months which was designed specifically for this trial and did not exist before. Participants could receive medication reminders and cardiac health education by the smartphone application or (2) the control group with usual care. The primary outcome was CABG secondary preventive medication adherence as measured by the translated Chinese version of the 8-item Morisky Medication Adherence Scale (MMAS-8) at 6 months after randomization. The secondary outcomes were mortality, major adverse cardiovascular and cerebrovascular events (MACCE), cardiovascular rehospitalization, self-reported secondary preventive medication use after 6 months of follow-up, blood pressure (BP), body mass index (BMI), and self-reported smoking status. All analyses were conducted using the intention-to-treat principle.
RESULTS


A total of 1000 patients (mean age, 57.28 [SD, 9.09] years; 85.5% male) with coronary heart disease after CABG were enrolled between September 2015 and September 2016 and were randomly assigned to the intervention (n = 501) or control group (n = 499). At 6 months, the proportion of low-adherence participants, categorized by MMAS-8 scores, was 11.8% in the intervention group and 11.7% in the control group (RR = 1.005, 95% CI 0.682 to 1.480, P = 1.000). Similar results were found in sensitivity analyses that considered participants who withdrew from the study, or were lost to follow-up as nonadherent. There were no significant differences in the secondary clinical outcome measures, and there were no significant differences in the primary outcome across the subgroups tested. In the intervention group, the proportion of participants who used and operated the application during the first month after CABG was 88.1%; however, the use rate decreased sharply from 42.5% in the second month to 9.2% by the end of the study (6 months).
CONCLUSIONS


A smartphone-based application supporting secondary prevention among patients after CABG did not lead to a greater adherence to secondary preventive medications. The limited room for improvement in medication adherence and the low participants' engagement with the smartphone applications might account for these non-significant outcomes.",2020,A smartphone-based application supporting secondary prevention among patients after CABG did not lead to a greater adherence to secondary preventive medications.,"['patients after CABG', 'coronary artery bypass grafting (CABG', 'patients after surgical coronary revascularization', '1000 patients who underwent isolated CABG at one of four large teaching hospitals in China; all enrolled participants had access to a smartphone and were able to operate at least three smartphone applications', '1000 patients (mean age, 57.28 [SD, 9.09] years; 85.5% male) with coronary heart disease after CABG were enrolled between September 2015 and September 2016']","['Surgical coronary revascularizatION', 'smartphone-based application', 'Smartphone-based application', 'medication reminders and cardiac health education by the smartphone application or (2) the control group with usual care', 'intervention group with an advanced smartphone application']","['proportion of low-adherence participants, categorized by MMAS-8 scores', 'mortality, major adverse cardiovascular and cerebrovascular events (MACCE), cardiovascular rehospitalization, self-reported secondary preventive medication use after 6 months of follow-up, blood pressure (BP), body mass index (BMI), and self-reported smoking status', 'CABG secondary preventive medication adherence as measured by the translated Chinese version of the 8-item Morisky Medication Adherence Scale (MMAS-8', 'medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0066409', 'cui_str': 'Methylmethacrylate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040710', 'cui_str': 'Translating'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",1000.0,0.0677726,A smartphone-based application supporting secondary prevention among patients after CABG did not lead to a greater adherence to secondary preventive medications.,"[{'ForeName': 'Chunyu', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chongyang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Junzhe', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hanning', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Limeng', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Huishan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular Surgery, General Hospital of Shenyang Military Region, Shenyang, Liaoning, China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiovascular Surgery, TEDA International Cardiovascular Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Tianjin, China.'}, {'ForeName': 'Chenfei', 'Initials': 'C', 'LastName': 'Rao', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: raochenfeifuwai@126.com.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: zhengzhe@fuwai.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.06.019']
1612,32745733,"Rationale and design of a prospective, randomized, controlled, multicenter study to evaluate the safety and efficacy of transcatheter heart valve replacement in female patients with severe symptomatic aortic stenosis requiring aortic valve intervention (Randomized researcH in womEn all comers wIth Aortic stenosis [RHEIA] trial).","BACKGROUND


Limited data suggest that transcatheter (TAVR) as compared with surgical aortic valve replacement (SAVR) may be more effective in female than male patients. To date, most evidence is derived from subgroup analyses of large trials, and a dedicated randomized trial evaluating whether there is a difference in outcomes between these interventions in women is warranted. The RHEIA trial will compare the safety and efficacy of TAVR with SAVR in women with severe symptomatic aortic stenosis requiring aortic valve intervention, irrespective of surgical risk.
METHODS/DESIGN


The RHEIA trial is a prospective, randomized, controlled study that will enroll up to 440 patients across 35 sites in Europe. Women with severe symptomatic aortic stenosis, with any but prohibitive surgical risk status, will be randomized 1:1 to undergo aortic valve intervention with either transfemoral TAVR with the SAPIEN 3 or SAPIEN 3 Ultra device or SAVR and followed up for 1 year. The objective is to determine whether TAVR is non-inferior to SAVR in this patient population and, if this is fulfilled whether TAVR is actually superior to SAVR. The primary safety/efficacy endpoint is a composite of all-cause mortality, all stroke, and re-hospitalization (for valve or procedure-related symptoms or worsening congestive heart failure) at 1 year post-procedure. Other outcomes (assessed at 30 days and/or 1 year) include all-cause mortality; bleeding, vascular, cardiac, cerebrovascular and renal complications; aortic valve prosthesis and left ventricular function; cognitive function, health status, and quality of life.
DISCUSSION


The RHEIA study has been designed to evaluate the safety and efficacy of TAVR compared with SAVR specifically in women with severe symptomatic aortic stenosis, irrespective of the level of surgical risk. The results will be the first to provide specific randomized evidence to guide treatment selection in female patients with severe symptomatic aortic stenosis.
TRIAL REGISTRATION


clinicaltrials.gov: NCT04160130.",2020,"The RHEIA study has been designed to evaluate the safety and efficacy of TAVR compared with SAVR specifically in women with severe symptomatic aortic stenosis, irrespective of the level of surgical risk.","['440 patients across 35 sites in Europe', 'female than male patients', 'Women with severe symptomatic aortic stenosis, with any but prohibitive surgical risk status', 'female patients with severe symptomatic aortic stenosis', 'women with severe symptomatic aortic stenosis requiring aortic valve intervention, irrespective of surgical risk', 'female patients with severe symptomatic aortic stenosis requiring aortic valve intervention (Randomized researcH in womEn all comers wIth Aortic stenosis [RHEIA', 'women with severe symptomatic aortic stenosis']","['surgical aortic valve replacement (SAVR', 'transcatheter (TAVR', 'transcatheter heart valve replacement', 'TAVR with SAVR', 'TAVR']","['composite of all-cause mortality, all stroke, and re-hospitalization (for valve or procedure-related symptoms or worsening congestive heart failure', 'safety and efficacy', 'cause mortality; bleeding, vascular, cardiac, cerebrovascular and renal complications; aortic valve prosthesis and left ventricular function; cognitive function, health status, and quality of life']","[{'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0003501', 'cui_str': 'Aortic valve structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0190173', 'cui_str': 'Heart valve replacement'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0182431', 'cui_str': 'Aortic valve prosthesis'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.159675,"The RHEIA study has been designed to evaluate the safety and efficacy of TAVR compared with SAVR specifically in women with severe symptomatic aortic stenosis, irrespective of the level of surgical risk.","[{'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Eltchaninoff', 'Affiliation': 'Department of Cardiology, Rouen University Hospital, FHU REMOD-VHF, Rouen, France. Electronic address: helene.eltchaninoff@chu-rouen.fr.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Bonaros', 'Affiliation': 'Department of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria. Electronic address: nikolaos.bonaros@tirol-kliniken.at.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Prendergast', 'Affiliation': ""St. Thomas' Hospital, London, United Kingdom. Electronic address: bernard.prendergast@gstt.nhs.uk.""}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Nietlispach', 'Affiliation': 'CardioVascularCenter, Hirslanden Klinik Im Park, Zurich, Switzerland. Electronic address: fabian.nietlispach@hirslanden.ch.'}, {'ForeName': 'Mariuca', 'Initials': 'M', 'LastName': 'Vasa-Nicotera', 'Affiliation': 'University Heart Center Frankfurt, Frankfurt, Germany. Electronic address: mariuca.vasa-nicotera@kgu.de.'}, {'ForeName': 'Alaide', 'Initials': 'A', 'LastName': 'Chieffo', 'Affiliation': 'Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy. Electronic address: chieffo.alaide@hsr.it.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Pibarot', 'Affiliation': 'Department of Cardiology, Quebec Heart & Lung Institute, Laval University, Quebec City, QC, Canada. Electronic address: philippe.pibarot@med.ulaval.ca.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bramlage', 'Affiliation': 'Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany. Electronic address: peter.bramlage@ippmed.de.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Sykorova', 'Affiliation': 'Edwards Lifesciences, Prague, Czech Republic. Electronic address: lenka_sykorova@edwards.com.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Kurucova', 'Affiliation': 'Edwards Lifesciences, Prague, Czech Republic. Electronic address: jana_kurucova@edwards.com.'}, {'ForeName': 'Jeroen J', 'Initials': 'JJ', 'LastName': 'Bax', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands. Electronic address: j.j.bax@lumc.nl.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland. Electronic address: Stephan.Windecker@insel.ch.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Dumonteil', 'Affiliation': 'Groupe Cardiovasculaire Interventionnel, Clinique Pasteur Toulouse, France. Electronic address: ndumonteil@clinique-pasteur.com.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Tchetche', 'Affiliation': 'Groupe Cardiovasculaire Interventionnel, Clinique Pasteur Toulouse, France. Electronic address: dtchetche@clinique-pasteur.com.'}]",American heart journal,['10.1016/j.ahj.2020.06.016']
1613,32745734,Optimal antiplatelet therapy for prevention of gastrointestinal injury evaluated by ANKON magnetically controlled capsule endoscopy: Rationale and design of the OPT-PEACE trial.,"BACKGROUND


Gastrointestinal injury is a common complication in patients treated with antiplatelet agents after percutaneous coronary intervention (PCI). However, the effects of different antiplatelet regimens on the incidence and severity of gastrointestinal injury have not been well studied, principally due to the lack of a low-risk sensitive and accurate detection system.
TRIAL DESIGN


OPT-PEACE is a multicenter, randomized, double-blind, placebo-controlled trial. Gastrointestinal injury will be evaluated with the ANKON magnetically controlled capsule endoscopy system (AMCE), a minimally invasive approach for detecting mucosal lesions in the stomach, duodenum and small intestine. Patients without AMCE-detected gastrointestinal erosions, ulceration or bleeding after drug-eluting stent implantation are enrolled and treated with open-label aspirin (100 mg/d) plus clopidogrel (75 mg/d) for 6 months. Thereafter, 480 event-free patients will undergo repeat AMCE and are randomly assigned in a 1:1:1 ratio to receive aspirin plus clopidogrel, aspirin plus placebo or clopidogrel plus placebo for an additional 6 months. A final AMCE is performed at 12 months. The primary endpoint is the incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding) within 12 months after enrollment.
CONCLUSIONS


OPT-PEACE is the first study to investigate the incidence and severity of gastrointestinal injury in patients receiving different antiplatelet therapy regimens after stent implantation. This trial will inform clinical decision-making for personalized antiplatelet therapy post-PCI.",2020,"The primary endpoint is the incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding) within 12 months after enrollment.
","['480 event-free patients will undergo repeat AMCE', 'patients receiving different antiplatelet therapy regimens after stent implantation', 'patients treated with antiplatelet agents after percutaneous coronary intervention (PCI']","['aspirin plus clopidogrel, aspirin plus placebo or clopidogrel plus placebo', 'open-label aspirin', 'clopidogrel', 'placebo']","['incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding', 'gastrointestinal erosions, ulceration or bleeding']","[{'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1721048', 'cui_str': 'Capsule endoscopy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0085826', 'cui_str': 'Antiplatelet agent'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1261962', 'cui_str': 'Gastrointestinal erosion'}]",,0.524049,"The primary endpoint is the incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding) within 12 months after enrollment.
","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Xiaozeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Bao', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Zhuan', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'Digestive Endoscopy Center, Department of Gastroenterology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Department of Endoscopy, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Heyang', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Zhaoshen', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Digestive Endoscopy Center, Department of Gastroenterology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Mount Sinai Heart and the Cardiovascular Research Foundation, New York.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China. Electronic address: hanyaling@263.net.'}]",American heart journal,['10.1016/j.ahj.2020.06.004']
1614,32750063,Family nurture intervention in the NICU increases autonomic regulation in mothers and children at 4-5 years of age: Follow-up results from a randomized controlled trial.,"BACKGROUND


Maturation of multiple neurobehavioral systems, including autonomic regulation, is altered by preterm birth. The purpose of this study was to determine the long-term effects of Family Nurture Intervention (FNI) in the NICU on autonomic regulation of preterm infants and their mothers.
METHOD


A subset of infants and mothers (48% of infants, 51% of mothers) randomly assigned to either standard are (SC), or SC plus the FNI in the NICU in a prior RCT (ClincalTrials.gov; NCT01439269) returned for follow-up assessments when the children were 4 to 5 years corrected age (CA). ECGs were collected for 10 minutes in mothers and their children while children were in their mothers' laps. Heart rate, standard deviation for heart rate, respiratory sinus arrhythmia (RSA)-an index of parasympathetic regulation, and a measure of vagal efficiency were quantified.
RESULTS


Both children and mothers in the FNI group had significantly greater levels of RSA compared to the SC group (child: mean difference = 0.60, 95% CI 0.17 to 1.03, p = 0.008; mother: mean difference = 0.64, 95% CI 0.07 to 1.21, p = 0.031). In addition, RSA increased more rapidly in FNI children between infancy and the 4 to 5-year follow-up time point (SC = +3.11±0.16 loge msec2, +3.67±0.19 loge msec2 for FNI, p<0.05). These results show that the rate of increase in RSA from infancy to childhood is more rapid in FNI subjects.
CONCLUSION


Although these preliminary follow-up results are based on approximately half of subjects originally enrolled in the RCT, they suggest that FNI-NICU led to healthier autonomic regulation in both mother and child, when measured during a brief face-to-face socioemotional interaction. A Pavlovian autonomic co-conditioning mechanism may underly these findings that can be exploited therapeutically.",2020,"Both children and mothers in the FNI group had significantly greater levels of RSA compared to the SC group (child: mean difference = 0.60, 95% CI 0.17 to 1.03, p = 0.008; mother: mean difference = 0.64, 95% CI 0.07 to 1.21, p = 0.031).","['mothers and children at 4-5 years of age', 'preterm infants and their mothers']","['RSA', 'Family nurture intervention', 'Family Nurture Intervention (FNI', 'NICU']","['Heart rate, standard deviation for heart rate, respiratory sinus arrhythmia (RSA)-an index of parasympathetic regulation, and a measure of vagal efficiency', 'autonomic regulation', 'levels of RSA', 'RSA']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0003813', 'cui_str': 'Sinus arrhythmia'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0003813', 'cui_str': 'Sinus arrhythmia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0640867,"Both children and mothers in the FNI group had significantly greater levels of RSA compared to the SC group (child: mean difference = 0.60, 95% CI 0.17 to 1.03, p = 0.008; mother: mean difference = 0.64, 95% CI 0.07 to 1.21, p = 0.031).","[{'ForeName': 'Martha G', 'Initials': 'MG', 'LastName': 'Welch', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Barone', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Porges', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Amie A', 'Initials': 'AA', 'LastName': 'Hane', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Katie Y', 'Initials': 'KY', 'LastName': 'Kwon', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Ludwig', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Raymond I', 'Initials': 'RI', 'LastName': 'Stark', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Surman', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Kolacz', 'Affiliation': 'Traumatic Stress Research Consortium, Kinsey Institute, Indiana University, Bloomington, IN, United States of America.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Myers', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY, United States of America.'}]",PloS one,['10.1371/journal.pone.0236930']
1615,32750431,Protocol for Partner2Lose: A randomized controlled trial to evaluate partner involvement on long-term weight loss.,"BACKGROUND


Behavioral interventions produce clinically significant weight reduction, with many participants regaining weight subsequently. Most interventions focus on an individual, but dietary and physical activity behaviors occur with, or are influenced by, domestic partners. According to interdependence theory, couples who approach behavior change as a problem to be tackled together versus independently are more likely to utilize communal coping processes to promote behavior change. We utilized interdependence theory to develop a partner-assisted intervention to increase long-term weight loss.
METHODS


Community-dwelling individuals (index participants) cohabitating with a partner with 1) overweight and at least one obesity-related comorbidity or 2) obesity are randomized to participate in a standard weight management program alone or with their partner. The weight management program involves biweekly, in-person, group sessions focusing on weight loss for six months, followed by three group sessions and nine telephone calls focusing on weight loss maintenance for twelve months. In the partner-assisted arm, partners participate in half of the group sessions and telephone calls. Couples receive training in principles of cognitive behavioral therapy for couples, including sharing thoughts and feelings and joint problem solving, to increase communal coping. The primary outcome is participant weight loss at 24 months, with caloric intake and moderate-intensity physical activity as secondary outcomes. Partner weight and caloric intake will also be analyzed. Mediation analyses will examine the role of interdependence variables and social support.
DISCUSSION


This trial will provide knowledge about effective ways to promote long-term weight loss and the role of interdependence constructs in weight loss. Clinical trials identifier: NCT03801174.",2020,"According to interdependence theory, couples who approach behavior change as a problem to be tackled together versus independently are more likely to utilize communal coping processes to promote behavior change.",['Community-dwelling individuals (index participants) cohabitating with a partner with 1) overweight and at least one obesity-related comorbidity or 2) obesity'],"['training in principles of cognitive behavioral therapy', 'standard weight management program alone or with their partner']","['Partner weight and caloric intake', 'participant weight loss at 24\u202fmonths, with caloric intake and moderate-intensity physical activity']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]","[{'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0164121,"According to interdependence theory, couples who approach behavior change as a problem to be tackled together versus independently are more likely to utilize communal coping processes to promote behavior change.","[{'ForeName': 'Corrine I', 'Initials': 'CI', 'LastName': 'Voils', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Surgery, 600 Highland Ave, K6/100 CSC, Madison, WI 53792-1690, USA; William S Middleton Memorial Veterans Hospital, 2500 Overlook Terrace (151), Madison, WI 53705, USA. Electronic address: voils@surgery.wisc.edu.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Shaw', 'Affiliation': 'Duke University School of Nursing, 307 Trent Dr., 1055 Clipp, Durham, NC 27710, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Adler', 'Affiliation': ""Center for Surgery and Public Health, Brigham and Women's Hospital, One Brigham Circle, 1620 Tremont Street Suite 2-016, Boston, MA 02120, USA.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Jeanes', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Surgery, 600 Highland Ave, K6/100 CSC, Madison, WI 53792-1690, USA.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': 'RTI International, 119 S. Main St., Union Trust Bldg., Suite 220, Seattle, WA 98104, USA.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Sharp', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Surgery, 600 Highland Ave, K6/100 CSC, Madison, WI 53792-1690, USA.'}, {'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'Cronin', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Surgery, 600 Highland Ave, K6/100 CSC, Madison, WI 53792-1690, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hetzel', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Biostatistics and Bioinformatics, 610 Walnut St, WARF 201, Madison, WI 53726, USA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Mao', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Biostatistics and Bioinformatics, 610 Walnut St, WARF 201, Madison, WI 53726, USA.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Johnson', 'Affiliation': ""Boca Raton Regional Hospital, Christine E. Lynn Women's Health & Wellness Institute, 690 Meadows Road, Boca Raton, FL 33486, USA.""}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Elwert', 'Affiliation': 'University of Wisconsin-Madison Department of Sociology, 11800 Observatory Dr, Madison, WI 53706, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Pabich', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Medicine, 1685 Highland Ave Madison, WI 53705-2281, USA.'}, {'ForeName': 'Kara L', 'Initials': 'KL', 'LastName': 'Gavin', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Surgery, 600 Highland Ave, K6/100 CSC, Madison, WI 53792-1690, USA.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Yancy', 'Affiliation': 'Duke University School of Medicine, Department of Medicine, 501 Douglas St., Durham, NC 27705, USA.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Porter', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, Box 90399, Durham, NC 27708, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106092']
1616,32750502,"Impact of age on efficacy and early mortality of initial sequential treatment versus upfront combination chemotherapy in patients with metastatic colorectal cancer: a subgroup analysis of a phase III trial (AIO KRK0110, XELAVIRI study).","INTRODUCTION


The XELAVIRI study compared application of fluoropyrimidine (FP) and bevacizumab (Bev) followed by sequential escalation to irinotecan (Iri), FP and Bev (arm A) to upfront combination therapy with FP, Iri and Bev (arm B) in patients with metastatic colorectal cancer (mCRC). To elucidate the impact of age on survival, we evaluated efficacy and early mortality in the underlying trial.
METHODS


Patients were stratified for age in three cohorts (<65 years, 65-74 years and ≥75 years). Survival end-points were expressed by the Kaplan-Meier method and compared by log-rank testing and Cox regression. Objective response and 60-day mortality were evaluated by chi-square testing.
RESULTS


The efficacy analyses suggest more substantial benefit from upfront combination chemotherapy in younger patients with mCRC. Elderly patients (≥75 years) derived limited benefit from upfront combination chemotherapy, particularly in terms of overall survival. Of 421 randomised patients, 13 patients (3.1%) died within 60 days after treatment initiation with the highest prevalence in elderly patients (1.6% < 65 years, 2.8% 65-74 years and 5.2% ≥ 75 years, p = 0.26). The frequency of 60-day mortality was significantly associated with age (with a maximum of 8.7% in patients aged ≥75 years) in patients undergoing upfront combination therapy (p = 0.027) but not in patients receiving sequential treatment (p = 0.63).
CONCLUSION


Combination therapy with FP, Iri and Bev does not substantially improve the outcome of patients aged ≥75 years as compared with sequential treatment algorithm. These patients appear to be at a relevant risk for 60-day mortality under Iri-based combination chemotherapy plus Bev.",2020,"CONCLUSION


Combination therapy with FP, Iri and Bev does not substantially improve the outcome of patients aged ≥75 years as compared with sequential treatment algorithm.","['patients with metastatic colorectal cancer', 'Elderly patients (≥75 years', 'younger patients with mCRC', 'patients aged ≥75 years', 'Patients were stratified for age in three cohorts (<65 years, 65-74 years and ≥75 years', 'patients with metastatic colorectal cancer (mCRC']","['upfront combination chemotherapy', 'fluoropyrimidine (FP) and bevacizumab (Bev) followed by sequential escalation to irinotecan (Iri), FP and Bev (arm A) to upfront combination therapy with FP, Iri and Bev (arm B']","['Objective response and 60-day mortality', 'frequency of 60-day mortality', 'efficacy and early mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0022077', 'cui_str': 'Iris structure'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",421.0,0.107606,"CONCLUSION


Combination therapy with FP, Iri and Bev does not substantially improve the outcome of patients aged ≥75 years as compared with sequential treatment algorithm.","[{'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Kurreck', 'Affiliation': 'Charité University Medicine, Department of Hematology, Oncology, and Tumor Immunology (CVK), Berlin, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'University Hospital Grosshadern, Ludwig Maximilians Universität (LMU), Department of Medical Oncology & Comprehensive Cancer Center, Munich, Germany; German Cancer Consortium (DKTK), DKFZ, Heidelberg, Germany.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Fischer von Weikersthal', 'Affiliation': 'Gesundheitszentrum St. Marien, Amberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Decker', 'Affiliation': 'Oncological Practice, Ravensburg, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Kaiser', 'Affiliation': 'Oncological Practice, Landshut, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Uhlig', 'Affiliation': 'Oncological Practice, Naunhof, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schenk', 'Affiliation': ""Clinic 'Barmherzige Brüder Regensburg', Regensburg, Germany.""}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Freiberg-Richter', 'Affiliation': 'Oncological Practice, Dresden, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Peuser', 'Affiliation': 'Oncological Practice am Diakonissenhaus, Leipzig, Germany.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Denzlinger', 'Affiliation': 'Marienhospital, Stuttgart, Germany.'}, {'ForeName': 'Ullrich', 'Initials': 'U', 'LastName': 'Graeven', 'Affiliation': 'Kliniken Maria Hilf GmbH, Mönchengladbach, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Schwaner', 'Affiliation': 'Oncological Practice Kurfürstendamm, Berlin, Germany.'}, {'ForeName': 'Arndt', 'Initials': 'A', 'LastName': 'Stahler', 'Affiliation': 'University Hospital Grosshadern, Ludwig Maximilians Universität (LMU), Department of Medical Oncology & Comprehensive Cancer Center, Munich, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Heinrich', 'Affiliation': 'University Hospital Grosshadern, Ludwig Maximilians Universität (LMU), Department of Medical Oncology & Comprehensive Cancer Center, Munich, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Jung', 'Affiliation': 'German Cancer Consortium (DKTK), DKFZ, Heidelberg, Germany; Ludwig Maximilians-University, Department of Pathology, Munich, Germany.'}, {'ForeName': 'Swantje', 'Initials': 'S', 'LastName': 'Held', 'Affiliation': 'ClinAssess GmbH, Leverkusen, Germany.'}, {'ForeName': 'Jobst C', 'Initials': 'JC', 'LastName': 'von Einem', 'Affiliation': 'Charité University Medicine Berlin, Department of Hematology, Oncology, and Tumor Immunology (CCM), Berlin, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Stintzing', 'Affiliation': 'Charité University Medicine Berlin, Department of Hematology, Oncology, and Tumor Immunology (CCM), Berlin, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Giessen-Jung', 'Affiliation': 'University Hospital Grosshadern, Ludwig Maximilians Universität (LMU), Department of Medical Oncology & Comprehensive Cancer Center, Munich, Germany.'}, {'ForeName': 'Dominik P', 'Initials': 'DP', 'LastName': 'Modest', 'Affiliation': 'Charité University Medicine, Department of Hematology, Oncology, and Tumor Immunology (CVK), Berlin, Germany. Electronic address: dominik.modest@charite.de.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.06.010']
1617,32750571,Recurrent venous thromboembolism during anticoagulation with edoxaban or warfarin: A post hoc analysis of the Hokusai-VTE trial.,"INTRODUCTION


Venous thromboembolism (VTE) may recur during anticoagulation, but the actual rate is not well established. In a post hoc analysis of the Hokusai-VTE trial we evaluated the risk and determinants of recurrent VTE of patients during anticoagulation with heparin, edoxaban or warfarin.
MATERIALS AND METHODS


The Hokusai-VTE study showed that in VTE patients edoxaban was non-inferior to warfarin with significantly less bleeding. Treatment duration ranged from 3 to 12 months. The recurrent VTE during anticoagulation period was defined as the VTE which occurred from the date of the first to the last dose (+3 days) of study drug.
RESULTS


147 of 8240 patients (1.8%) had a recurrent VTE during anticoagulant treatment. Median duration of anticoagulation was 267 days. 80 (54%) patients recurred within the first 30 days, 39 of those during heparin lead-in. 23 of 147 patients died of pulmonary embolism (PE) during anticoagulation (case fatality rate 15.6%). 13 of those fatalities (57%) occurred during the first 30 days; 4 of those during heparin lead-in. The recurrence risk was numerically lower in patients assigned to edoxaban compared to those assigned to warfarin, particularly beyond 30 days. We observed a trend towards a higher proportion of men, high NT-proBNP levels and obesity at the time of diagnosis among patients with early recurrence and mortality in particular.
CONCLUSION


The risk of recurrent VTE and PE-related mortality during the time of anticoagulation is low but noteworthy. Further studies are warranted to sharpen the risk profile of VTE patients in order to improve treatment and reduce mortality.",2020,23 of 147 patients died of pulmonary embolism (PE) during anticoagulation (case fatality rate 15.6%).,"['23 of 147 patients died of pulmonary embolism (PE) during anticoagulation (case fatality rate 15.6', '147 of 8240 patients (1.8%) had a recurrent VTE during anticoagulant treatment']","['edoxaban', 'warfarin', 'heparin, edoxaban or warfarin', 'VTE patients edoxaban', 'edoxaban or warfarin']","['Median duration of anticoagulation', 'recurrence risk', 'Recurrent venous thromboembolism', 'bleeding']","[{'cui': 'C1306577', 'cui_str': 'O/E - dead'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0282250', 'cui_str': 'Case fatality rate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",8240.0,0.0356656,23 of 147 patients died of pulmonary embolism (PE) during anticoagulation (case fatality rate 15.6%).,"[{'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Eichinger', 'Affiliation': 'Dept. of Medicine I, Medical University of Vienna, Austria. Electronic address: sabine.eichinger@meduniwien.ac.at.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Daiichi-Sankyo Pharma Development, Basking Ridge, NJ, United States of America.'}, {'ForeName': 'Minggao', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'Daiichi-Sankyo Pharma Development, Basking Ridge, NJ, United States of America.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Grosso', 'Affiliation': 'Daiichi-Sankyo Pharma Development, Basking Ridge, NJ, United States of America.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Kyrle', 'Affiliation': 'Dept. of Medicine I, Medical University of Vienna, Austria.'}]",Thrombosis research,['10.1016/j.thromres.2020.07.028']
1618,32716479,Continuous vs Routine Electroencephalogram in Critically Ill Adults With Altered Consciousness and No Recent Seizure: A Multicenter Randomized Clinical Trial.,"Importance


In critically ill patients with altered consciousness, continuous electroencephalogram (cEEG) improves seizure detection, but is resource-consuming compared with routine EEG (rEEG). It is also uncertain whether cEEG has an effect on outcome.
Objective


To assess whether cEEG is associated with reduced mortality compared with rEEG.
Design, Setting, and Participants


The pragmatic multicenter Continuous EEG Randomized Trial in Adults (CERTA) was conducted between 2017 and 2018, with follow-up of 6 months. Outcomes were assessed by interviewers blinded to interventions.The study took place at 4 tertiary hospitals in Switzerland (intensive and intermediate care units). Depending on investigators' availability, we pragmatically recruited critically ill adults having Glasgow Coma Scale scores of 11 or less or Full Outline of Responsiveness score of 12 or less, without recent seizures or status epilepticus. They had cerebral (eg, brain trauma, cardiac arrest, hemorrhage, or stroke) or noncerebral conditions (eg, toxic-metabolic or unknown etiology), and EEG was requested as part of standard care. An independent physician provided emergency informed consent.
Interventions


Participants were randomized 1:1 to cEEG for 30 to 48 hours vs 2 rEEGs (20 minutes each), interpreted according to standardized American Clinical Neurophysiology Society guidelines.
Main Outcomes and Measures


Mortality at 6 months represented the primary outcome. Secondary outcomes included interictal and ictal features detection and change in therapy.
Results


We analyzed 364 patients (33% women; mean [SD] age, 63 [15] years). At 6 months, mortality was 89 of 182 in those with cEEG and 88 of 182 in those with rEEG (adjusted relative risk [RR], 1.02; 95% CI, 0.83-1.26; P = .85). Exploratory comparisons within subgroups stratifying patients according to age, premorbid disability, comorbidities on admission, deeper consciousness reduction, and underlying diagnoses revealed no significant effect modification. Continuous EEG was associated with increased detection of interictal features and seizures (adjusted RR, 1.26; 95% CI, 1.08-1.15; P = .004 and 3.37; 95% CI, 1.63-7.00; P = .001, respectively) and more frequent adaptations in antiseizure therapy (RR, 1.84; 95% CI, 1.12-3.00; P = .01).
Conclusions and Relevance


This pragmatic trial shows that in critically ill adults with impaired consciousness and no recent seizure, cEEG leads to increased seizure detection and modification of antiseizure treatment but is not related to improved outcome compared with repeated rEEG. Pending larger studies, rEEG may represent a valid alternative to cEEG in centers with limited resources.
Trial Registration


ClinicalTrials.gov Identifier: NCT03129438.",2020,"At 6 months, mortality was 89 of 182 in those with cEEG and 88 of 182 in those with rEEG (adjusted relative risk [RR], 1.02; 95% CI, 0.83-1.26; P = .85).","['critically ill patients with altered consciousness', '4 tertiary hospitals in Switzerland (intensive and intermediate care units', 'critically ill adults with impaired consciousness', '364 patients (33% women; mean [SD] age, 63 [15] years', 'Critically Ill Adults With Altered Consciousness and No Recent Seizure', 'critically ill adults having Glasgow Coma Scale scores of 11 or less or Full Outline of Responsiveness score of 12 or less, without recent seizures or status epilepticus']","['cEEG', 'continuous electroencephalogram (cEEG', 'Continuous vs Routine Electroencephalogram']","['detection of interictal features and seizures', 'mortality', 'interictal and ictal features detection and change in therapy', 'cerebral (eg, brain trauma, cardiac arrest, hemorrhage, or stroke) or noncerebral conditions (eg, toxic-metabolic or unknown etiology']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0234428', 'cui_str': 'Disturbance of consciousness'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600661', 'cui_str': 'Outlines'}, {'cui': 'C0038220', 'cui_str': 'Status epilepticus'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]",,0.282436,"At 6 months, mortality was 89 of 182 in those with cEEG and 88 of 182 in those with rEEG (adjusted relative risk [RR], 1.02; 95% CI, 0.83-1.26; P = .85).","[{'ForeName': 'Andrea O', 'Initials': 'AO', 'LastName': 'Rossetti', 'Affiliation': 'Department of Neurology, Lausanne University Hospital, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Kaspar', 'Initials': 'K', 'LastName': 'Schindler', 'Affiliation': 'Sleep-Wake-Epilepsy-Center, Department of Neurology, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Sutter', 'Affiliation': 'Clinic for Intensive Care Medicine, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Rüegg', 'Affiliation': 'Department of Neurology, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Zubler', 'Affiliation': 'Sleep-Wake-Epilepsy-Center, Department of Neurology, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Novy', 'Affiliation': 'Department of Neurology, Lausanne University Hospital, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Oddo', 'Affiliation': 'Department of Intensive Care Medicine, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Loane', 'Initials': 'L', 'LastName': 'Warpelin-Decrausaz', 'Affiliation': 'Clinical Trial Unit, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Alvarez', 'Affiliation': 'Department of Neurology, Lausanne University Hospital, University of Lausanne, Lausanne, Switzerland.'}]",JAMA neurology,['10.1001/jamaneurol.2020.2264']
1619,32711800,"Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial.","BACKGROUND


Tenofovir alafenamide shows high antiviral efficacy and improved renal and bone safety compared with tenofovir disoproxil fumarate when used for HIV treatment. Here, we report primary results from a blinded phase 3 study evaluating the efficacy and safety of pre-exposure prophylaxis (PrEP) with emtricitabine and tenofovir alafenamide versus emtricitabine and tenofovir disoproxil fumarate for HIV prevention.
METHODS


This study is an ongoing, randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial done at 94 community, public health, and hospital-associated clinics located in regions of Europe and North America, where there is a high incidence of HIV or prevalence of people living with HIV, or both. We enrolled adult cisgender men who have sex with men and transgender women who have sex with men, both with a high risk of acquiring HIV on the basis of their self-reported sexual behaviour in the past 12 weeks or their recent history (within 24 weeks of enrolment) of bacterial sexually transmitted infections. Participants with current or previous use of PrEP with emtricitabine and tenofovir disoproxil fumarate were not excluded. We used a computer-generated random allocation sequence to randomly assign (1:1) participants to receive either emtricitabine (200 mg) and tenofovir alafenamide (25 mg) tablets daily, with matched placebo tablets (emtricitabine and tenofovir alafenamide group), or emtricitabine (200 mg) and tenofovir disoproxil fumarate (300 mg) tablets daily, with matched placebo tablets (emtricitabine and tenofovir disoproxil fumarate group). As such, all participants were given two tablets. The trial sponsor, investigators, participants, and the study staff who provided the study drugs, assessed the outcomes, and collected the data were masked to group assignment. The primary efficacy outcome was incident HIV infection, which was assessed when all participants had completed 48 weeks of follow-up and half of all participants had completed 96 weeks of follow-up. This full analysis set included all randomly assigned participants who had received at least one dose of the assigned study drug and had at least one post-baseline HIV test. Non-inferiority of emtricitabine and tenofovir alafenamide to emtricitabine and tenofovir disoproxil fumarate was established if the upper bound of the 95·003% CI of the HIV incidence rate ratio (IRR) was less than the prespecified non-inferiority margin of 1·62. We prespecified six secondary bone mineral density and renal biomarker safety endpoints to evaluate using the safety analysis set. This analysis set included all randomly assigned participants who had received at least one dose of the assigned study drug. This trial is registered with ClinicalTrials.gov, NCT02842086, and is no longer recruiting.
FINDINGS


Between Sept 13, 2016, and June 30, 2017, 5387 (92%) of 5857 participants were randomly assigned and received emtricitabine and tenofovir alafenamide (n=2694) or emtricitabine and tenofovir disoproxil fumarate (n=2693). At the time of the primary efficacy analysis (ie, when all participants had completed 48 weeks and 50% had completed 96 weeks) emtricitabine and tenofovir alafenamide was non-inferior to emtricitabine and tenofovir disoproxil fumarate for HIV prevention, as the upper limit of the 95% CI of the IRR, was less than the prespecified non-inferiority margin of 1·62 (IRR 0·47 [95% CI 0·19-1·15]). After 8756 person-years of follow-up, 22 participants were diagnosed with HIV, seven participants in the emtricitabine and tenofovir alafenamide group (0·16 infections per 100 person-years [95% CI 0·06-0·33]), and 15 participants in the emtricitabine and tenofovir disoproxil fumarate group (0·34 infections per 100 person-years [0·19-0·56]). Both regimens were well tolerated, with a low number of participants reporting adverse events that led to discontinuation of the study drug (36 [1%] of 2694 participants in the emtricitabine and tenofovir alafenamide group vs 49 [2%] of 2693 participants in the emtricitabine and tenofovir disoproxil fumarate group). Emtricitabine and tenofovir alafenamide was superior to emtricitabine and tenofovir disoproxil fumarate in all six prespecified bone mineral density and renal biomarker safety endpoints.
INTERPRETATION


Daily emtricitabine and tenofovir alafenamide shows non-inferior efficacy to daily emtricitabine and tenofovir disoproxil fumarate for HIV prevention, and the number of adverse events for both regimens was low. Emtricitabine and tenofovir alafenamide had more favourable effects on bone mineral density and biomarkers of renal safety than emtricitabine and tenofovir disoproxil fumarate.
FUNDING


Gilead Sciences.",2020,"Emtricitabine and tenofovir alafenamide had more favourable effects on bone mineral density and biomarkers of renal safety than emtricitabine and tenofovir disoproxil fumarate.
","['group (0·34 infections per 100 person-years [0·19-0·56', 'Between Sept 13, 2016, and June 30, 2017, 5387 (92%) of 5857 participants', 'enrolled adult cisgender men who have sex with men and transgender women who have sex with men, both with a high risk of acquiring HIV on the basis of their self-reported sexual behaviour in the past 12 weeks or their recent history (within 24 weeks of enrolment) of bacterial sexually transmitted infections', 'After 8756 person-years of follow-up, 22 participants were diagnosed with HIV, seven participants in the', '94 community, public health, and hospital-associated clinics located in regions of Europe and North America', '15 participants in the', 'Participants with current or previous use of PrEP with', 'HIV pre-exposure prophylaxis (DISCOVER', 'group (0·16 infections per 100 person-years']","['Tenofovir alafenamide', 'tenofovir alafenamide', 'emtricitabine', 'emtricitabine and tenofovir alafenamide to emtricitabine and tenofovir disoproxil fumarate', 'emtricitabine and tenofovir alafenamide (n=2694) or emtricitabine and tenofovir disoproxil fumarate', 'emtricitabine and tenofovir alafenamide', 'placebo tablets (emtricitabine and tenofovir alafenamide group), or emtricitabine (200 mg) and tenofovir disoproxil fumarate', 'Emtricitabine and tenofovir alafenamide', 'placebo tablets (emtricitabine and tenofovir disoproxil fumarate group', 'Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate', 'tenofovir disoproxil fumarate', 'pre-exposure prophylaxis (PrEP) with emtricitabine and tenofovir alafenamide versus emtricitabine and tenofovir disoproxil fumarate', 'emtricitabine and tenofovir disoproxil fumarate']","['bone mineral density and biomarkers of renal safety', 'incident HIV infection', 'antiviral efficacy and improved renal and bone safety', 'efficacy and safety', 'bone mineral density and renal biomarker safety endpoints', 'HIV incidence rate ratio (IRR']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C1096319', 'cui_str': 'Prophylaxis against HIV infection'}]","[{'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C4059167', 'cui_str': 'emtricitabine and tenofovir alafenamide'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",22.0,0.592697,"Emtricitabine and tenofovir alafenamide had more favourable effects on bone mineral density and biomarkers of renal safety than emtricitabine and tenofovir disoproxil fumarate.
","[{'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Mayer', 'Affiliation': 'The Fenway Institute, Fenway Health, Boston, MA, USA; Department of Medicine, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'Infectious Diseases Department, Hopitaux Saint-Louis Lariboisière, University of Paris and INSERM U944, Paris, France.'}, {'ForeName': 'Melanie A', 'Initials': 'MA', 'LastName': 'Thompson', 'Affiliation': 'AIDS Research Consortium of Atlanta, Atlanta, GA, USA.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Anderson', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Karam C', 'Initials': 'KC', 'LastName': 'Mounzer', 'Affiliation': 'Philadelphia FIGHT, Philadelphia, PA, USA.'}, {'ForeName': 'Joss J', 'Initials': 'JJ', 'LastName': 'De Wet', 'Affiliation': 'Spectrum Health, Vancouver, BC, Canada.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'DeJesus', 'Affiliation': 'Orlando Immunology Center, Orlando, FL, USA.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Jessen', 'Affiliation': 'Praxis Jessen(2)\u2008+\u2008Kollegen, Berlin, Germany.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Grant', 'Affiliation': 'San Francisco AIDS Foundation, and University of California, San Francisco, CA, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Ruane', 'Affiliation': 'Ruane Medical and Liver Health Institute, Los Angeles, CA, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Wong', 'Affiliation': 'Department of Biometrics, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Ebrahimi', 'Affiliation': 'Department of Biometrics, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Lijie', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': 'Department of Biometrics, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Mathias', 'Affiliation': 'Department of Clinical Pharmacology, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Callebaut', 'Affiliation': 'Department of Virology, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Sean E', 'Initials': 'SE', 'LastName': 'Collins', 'Affiliation': 'Department of HIV and Emerging Viral Infections Clinical Research, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Moupali', 'Initials': 'M', 'LastName': 'Das', 'Affiliation': 'Department of HIV and Emerging Viral Infections Clinical Research, Gilead Sciences, Foster City, CA, USA. Electronic address: moupali.as@gilead.com.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'McCallister', 'Affiliation': 'Department of HIV and Emerging Viral Infections Clinical Research, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Brainard', 'Affiliation': 'Department of HIV and Emerging Viral Infections Clinical Research, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Brinson', 'Affiliation': 'Central Texas Clinical Research, Austin, TX, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Clarke', 'Affiliation': 'Royal Sussex County Hospital, Brighton and Sussex University Hospitals National Health Service (NHS) Trust, Brighton, UK.'}, {'ForeName': 'Pep', 'Initials': 'P', 'LastName': 'Coll', 'Affiliation': 'BCN Checkpoint and IrsiCaixa-AIDS Research Institute, Barcelona, Spain.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Post', 'Affiliation': ""King's College Hospital NHS Foundation Trust, King's College Hospital, London, UK.""}, {'ForeName': 'C Bradley', 'Initials': 'CB', 'LastName': 'Hare', 'Affiliation': 'Department of Adult and Family Medicine, Kaiser Permanente San Francisco Medical Center, San Francisco, CA, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31065-5']
1620,32711801,"Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis (JADE MONO-1): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial.","BACKGROUND


Abrocitinib, an oral selective Janus kinase 1 inhibitor, was effective and well tolerated in adults with moderate-to-severe atopic dermatitis in a phase 2b trial. We aimed to assess the efficacy and safety of abrocitinib monotherapy in adolescents and adults with moderate-to-severe atopic dermatitis.
METHODS


In this multicentre, double-blind, randomised phase 3 trial (JADE MONO-1), patients (aged ≥12 years) with moderate-to-severe atopic dermatitis (Investigator Global Assessment score ≥3, Eczema Area and Severity Index [EASI] score ≥16, percentage of body surface area affected ≥10%, and Peak Pruritus Numerical Rating Scale score ≥4) with a bodyweight of 40 kg or more, were enrolled at 69 sites in Australia, Canada, Europe, and the USA. Patients were randomly assigned (2:2:1) to oral abrocitinib 100 mg, abrocitinib 200 mg, or placebo once daily for 12 weeks. Randomisation was done using an interactive response technology system, stratified by baseline disease severity and age. Patients, investigators, and the funder of the study were masked to study treatment. The coprimary endpoints were the proportion of patients who had achieved an Investigator Global Assessment response (score of 0 [clear] or 1 [almost clear] with a ≥2-grade improvement from baseline), and the proportion of patients who achieved at least a 75% improvement in EASI score from baseline (EASI-75) score, both assessed at week 12. Efficacy was assessed in the full analysis set, which included all randomised patients who received at least one dose of study medication. Safety was assessed in all randomised patients. This study is registered with ClinicalTrials.gov, NCT03349060.
FINDINGS


Between Dec 7, 2017, and March 26, 2019, 387 patients were enrolled: 156 were assigned to abrocitinib 100 mg, 154 to abrocitinib 200 mg, and 77 to placebo. All enrolled patients received at least one dose of study treatment and thus were evaluable for 12-week efficacy. Of the patients with available data for the coprimary endpoints at week 12, the proportion of patients who had achieved an Investigator Global Assessment response was significantly higher in the abrocitinib 100 mg group than in the placebo group (37 [24%] of 156 patients vs six [8%] of 76 patients; p=0·0037) and in the abrocitinib 200 mg group compared with the placebo group (67 [44%] of 153 patients vs six [8%] of 76 patients; p<0·0001). Of the patients with available data for the coprimary endpoints at week 12, compared with the placebo group, the proportion of patients who had achieved an EASI-75 response was significantly higher in the abrocitinib 100 mg group (62 [40%] of 156 patients vs nine [12%] of 76 patients; p<0·0001) and abrocitinib 200 mg group (96 [63%] of 153 patients vs nine [12%] of 76 patients; p<0·0001). Adverse events were reported in 108 (69%) of 156 patients in the abrocitinib 100 mg group, 120 (78%) of 154 patients in the abrocitinib 200 mg group, and 44 (57%) of 77 patients in the placebo group. Serious adverse events were reported in five (3%) of 156 patients in the abrocitinib 100 mg group, five (3%) of 154 patients in the abrocitinib 200 mg group, and three (4%) of 77 patients in the placebo group. No treatment-related deaths were reported.
INTERPRETATION


Monotherapy with oral abrocitinib once daily was effective and well tolerated in adolescents and adults with moderate-to-severe atopic dermatitis.
FUNDING


Pfizer.",2020,"Serious adverse events were reported in five (3%) of 156 patients in the abrocitinib 100 mg group, five (3%) of 154 patients in the abrocitinib 200 mg group, and three (4%) of 77 patients in the placebo group.","['adolescents and adults with moderate-to-severe atopic dermatitis', 'patients (aged ≥12 years) with moderate-to-severe atopic dermatitis (Investigator Global Assessment score ≥3, Eczema Area and Severity Index [EASI] score ≥16, percentage of body surface area affected ≥10%, and Peak Pruritus Numerical Rating Scale score ≥4) with a bodyweight of 40 kg or more, were enrolled at 69 sites in Australia, Canada, Europe, and the USA', '387 patients were enrolled: 156', 'adults and adolescents with moderate-to-severe atopic dermatitis (JADE MONO-1', 'adults with moderate-to-severe atopic dermatitis', 'Between Dec 7, 2017, and March 26, 2019']","['abrocitinib 100 mg, 154 to abrocitinib 200 mg, and 77 to placebo', 'abrocitinib monotherapy', 'oral abrocitinib 100 mg, abrocitinib 200 mg, or placebo', 'abrocitinib', 'placebo']","['Safety', 'proportion of patients who had achieved an Investigator Global Assessment response', 'Investigator Global Assessment response', 'Adverse events', 'Efficacy and safety', 'efficacy and safety', 'Efficacy', 'EASI-75 response', 'EASI score', 'Serious adverse events']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",387.0,0.611278,"Serious adverse events were reported in five (3%) of 156 patients in the abrocitinib 100 mg group, five (3%) of 154 patients in the abrocitinib 200 mg group, and three (4%) of 77 patients in the placebo group.","[{'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Sinclair', 'Affiliation': 'Sinclair Dermatology, Melbourne, VIC, Australia.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Forman', 'Affiliation': 'ForCare Clinical Research, Tampa, FL, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wollenberg', 'Affiliation': 'Department of Dermatology, Ludwig Maximilian University of Munich, Munich, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Aschoff', 'Affiliation': 'University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cork', 'Affiliation': ""Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield Children's Hospital, Sheffield Teaching Hospitals, Sheffield, UK.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bieber', 'Affiliation': 'Department of Dermatology and Allergy, University Hospital, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Jacob P', 'Initials': 'JP', 'LastName': 'Thyssen', 'Affiliation': 'Department of Dermatology and Allergy, Herlev-Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Yosipovitch', 'Affiliation': 'Miami Itch Center, Miller School of Medicine, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Flohr', 'Affiliation': ""Unit for Population-Based Dermatology Research, St John's Institute of Dermatology, Guy's and St Thomas' NHS Foundation Trust, King's College London, London, UK.""}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Magnolo', 'Affiliation': 'University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Maari', 'Affiliation': 'Innovaderm Research, Montréal, QC, Canada; University of Montreal Hospital Center, Montréal, QC, Canada.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Feeney', 'Affiliation': 'Pfizer UK, Surrey, UK.'}, {'ForeName': 'Pinaki', 'Initials': 'P', 'LastName': 'Biswas', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Svitlana', 'Initials': 'S', 'LastName': 'Tatulych', 'Affiliation': 'Pfizer, Groton, CT, USA.'}, {'ForeName': 'Hernan', 'Initials': 'H', 'LastName': 'Valdez', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Rojo', 'Affiliation': 'Pfizer, Groton, CT, USA. Electronic address: ricardo.rojo@pfizer.com.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)30732-7']
1621,32711802,"Continuing versus tapering glucocorticoids after achievement of low disease activity or remission in rheumatoid arthritis (SEMIRA): a double-blind, multicentre, randomised controlled trial.","BACKGROUND


Patients with inflammatory diseases, such as rheumatoid arthritis, often receive glucocorticoids, but long-term use can produce adverse effects. Evidence from randomised controlled trials to guide tapering of oral glucocorticoids is scarce. We investigated a scheme for tapering oral glucocorticoids compared with continuing low-dose oral glucocorticoids in patients with rheumatoid arthritis.
METHODS


The Steroid EliMination In Rheumatoid Arthritis (SEMIRA) trial was a double-blind, multicentre, two parallel-arm, randomised controlled trial done at 39 centres from six countries (France, Germany, Italy, Russia, Serbia, and Tunisia). Adult patients with rheumatoid arthritis receiving tocilizumab and glucocorticoids 5-15 mg per day for 24 weeks or more were eligible for inclusion if they had received prednisone 5 mg per day for 4 weeks or more and had stable low disease activaity, confirmed by a Disease Activity Score for 28 joints-erythrocyte sedimentation rate (DAS28-ESR) of 3·2 or less 4-6 weeks before and on the day of randomisation. Patients were randomly assigned 1:1 to either continue masked prednisone 5 mg per day for 24 weeks or to taper masked prednisone reaching 0 mg per day at week 16. All patients received tocilizumab (162 mg subcutaneously every week or 8 mg/kg intravenously every 4 weeks) with or without csDMARDs maintained at stable doses during the entire 24-week study. The primary outcome was the difference in mean DAS28-ESR change from baseline to week 24, with a difference of more than 0·6 defined as clinically relevant between the continued-prednisone group and the tapered-prednisone group. The trial is registered with ClinicalTrials.gov, NCT02573012.
FINDINGS


Between Oct 21, 2015, and June 9, 2017, 421 patients were screened and 259 (200 [77%] women and 59 [23%] men) were recruited onto the trial. In all 128 patients assigned to the continued-prednisone regimen, disease activity control was superior to that in all 131 patients assigned to the tapered-prednisone regimen; the estimated mean change in DAS28-ESR from baseline to week 24 was 0·54 (95% CI 0·35-0·73) with tapered prednisone and -0·08 (-0·27 to 0·12) with continued prednisone (difference 0·61 [0·35-0·88]; p<0·0001), favouring continuing prednisone 5 mg per day for 24 weeks. Treatment was regarded as successful (defined as low disease activity at week 24, plus absence of rheumatoid arthritis flare for 24 weeks and no confirmed adrenal insufficiency) in 99 (77%) patients in the continued-prednisone group versus 85 (65%) patients in the tapered-prednisone group (relative risk 0·83; 95% CI 0·71-0·97). Serious adverse events occurred in seven (5%) patients in the tapered-prednisone group and four (3%) patients in the continued-prednisone group; no patients had symptomatic adrenal insufficiency.
INTERPRETATION


In patients who achieved low disease activity with tocilizumab and at least 24 weeks of glucocorticoid treatment, continuing glucocorticoids at 5 mg per day for 24 weeks provided safe and better disease control than tapering glucocorticoids, although two-thirds of patients were able to safely taper their glucocorticoid dose.
FUNDING


F Hoffmann-La Roche.",2020,"In all 128 patients assigned to the continued-prednisone regimen, disease activity control was superior to that in all 131 patients assigned to the tapered-prednisone regimen; the estimated mean change in DAS28-ESR from baseline to week 24 was 0·54 (95% CI 0·35-0·73) with tapered prednisone and -0·08","['Adult patients with rheumatoid arthritis receiving', 'Between Oct 21, 2015, and June 9, 2017, 421 patients were screened and 259 (200 [77', '0·35-0·88', 'patients with rheumatoid arthritis', '23%] men) were recruited onto the trial', '39 centres from six countries (France, Germany, Italy, Russia, Serbia, and Tunisia', 'women and 59']","['prednisone', 'Continuing versus tapering glucocorticoids', 'tocilizumab', 'continue masked prednisone', 'tapered prednisone and -0·08', 'glucocorticoids', 'tocilizumab and glucocorticoids', 'glucocorticoid', 'continuing low-dose oral glucocorticoids']","['symptomatic adrenal insufficiency', 'mean DAS28-ESR change', 'Steroid EliMination', 'disease activity control', 'Serious adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0036708', 'cui_str': 'Republic of Serbia'}, {'cui': 'C0041388', 'cui_str': 'Tunisia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0001623', 'cui_str': 'Hypoadrenalism'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",421.0,0.383193,"In all 128 patients assigned to the continued-prednisone regimen, disease activity control was superior to that in all 131 patients assigned to the tapered-prednisone regimen; the estimated mean change in DAS28-ESR from baseline to week 24 was 0·54 (95% CI 0·35-0·73) with tapered prednisone and -0·08","[{'ForeName': 'Gerd R', 'Initials': 'GR', 'LastName': 'Burmester', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin Berlin, Free University and Humboldt University of Berlin, Berlin, Germany. Electronic address: gerd.burmester@charite.de.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Buttgereit', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin Berlin, Free University and Humboldt University of Berlin, Berlin, Germany.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Bernasconi', 'Affiliation': 'Pharmaceuticals Division, F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Álvaro-Gracia', 'Affiliation': 'Hospital General Universitario Gregorio Marañon, Universidad Complutense de Madrid, Spain.'}, {'ForeName': 'Nidia', 'Initials': 'N', 'LastName': 'Castro', 'Affiliation': 'Pharmaceuticals Division, F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Rheumatology Service, Université Paris-Descartes, Paris, France.'}, {'ForeName': 'Cem', 'Initials': 'C', 'LastName': 'Gabay', 'Affiliation': 'Department of Rheumatology, Hôpital Cochin, Geneva University Hospitals and Geneva School of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Jacob M', 'Initials': 'JM', 'LastName': 'van Laar', 'Affiliation': 'University Medical Centre Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Jan Michael', 'Initials': 'JM', 'LastName': 'Nebesky', 'Affiliation': 'Pharmaceuticals Division, F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Attila', 'Initials': 'A', 'LastName': 'Pethoe-Schramm', 'Affiliation': 'Pharmaceuticals Division, F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Salvarani', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Università di Modena e Reggio Emilia and Azienda unità sanitaria locale-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Marc Y', 'Initials': 'MY', 'LastName': 'Donath', 'Affiliation': 'Department of Rheumatology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Markus R', 'Initials': 'MR', 'LastName': 'John', 'Affiliation': 'Pharmaceuticals Division, F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30636-X']
1622,32713850,Self-directed multimedia process for delivering participant informed consent.,"OBJECTIVE


Obtaining informed consent is a cornerstone requirement of conducting ethical research. Traditional paper-based consent is often excessively lengthy and may fail to achieve the desired participant understanding of study requirements. Multimedia tools including video and audio may be a useful alternative. This study aimed to determine the efficacy, usability and acceptability of self-directed multimedia delivery of participant consent.
DESIGN


It is a single-centre, randomised, prospective study to determine the efficacy, usability and acceptability of a self-directed multimedia consent process (intervention) compared with the traditional paper-based approach (control). The intervention was free of research staff, with computer-based finger-signed consent.
SETTING


Pathology blood collection services in Tasmania, Australia.
PARTICIPANTS


298 participants (63±8 years; 51% female individuals) referred from general practice were randomised to intervention (n=146) and control (n=152).
OUTCOME MEASURES


Efficacy, usability and acceptability of the allocated consent process were assessed by a questionnaire.
RESULTS


All participants successfully completed the allocated interventions. Efficacy parameters were higher among intervention participants, including a better understanding of study requirements compared with controls (p<0.05 all). Intervention participants were more likely to engage with the study information and spend more time on the consent process (p=<0.001 and p=0.006, respectively). Both groups reported similar levels of acceptability, although more control participants reported that the study information was too long (24% vs 14%; p=0.020).
CONCLUSION


A self-directed multimedia consent process is effective for achieving participant understanding and obtaining consent free of research staff. Thus, multimedia represents a viable method to reduce the burden on researchers, meet participant needs and achieve informed consent in clinical research.",2020,"Efficacy parameters were higher among intervention participants, including a better understanding of study requirements compared with controls (p<0.05 all).","['Pathology blood collection services in Tasmania, Australia', '298 participants (63±8 years; 51% female individuals) referred from general practice were randomised to intervention (n=146) and control (n=152']","['self-directed multimedia consent process (intervention', 'traditional paper-based approach (control']","['Efficacy, usability and acceptability of the allocated consent process', 'likely to engage with the study information and spend more time on the consent process', 'efficacy, usability and acceptability', 'Efficacy parameters', 'levels of acceptability']","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0039335', 'cui_str': 'Tasmania'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",298.0,0.0393312,"Efficacy parameters were higher among intervention participants, including a better understanding of study requirements compared with controls (p<0.05 all).","[{'ForeName': 'Niamh', 'Initials': 'N', 'LastName': 'Chapman', 'Affiliation': 'Menzies Institute for Medical Research, College of Health and Medicine, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'McWhirter', 'Affiliation': 'Menzies Institute for Medical Research, College of Health and Medicine, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Matthew K', 'Initials': 'MK', 'LastName': 'Armstrong', 'Affiliation': 'Menzies Institute for Medical Research, College of Health and Medicine, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Fonseca', 'Affiliation': 'Menzies Institute for Medical Research, College of Health and Medicine, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Campbell', 'Affiliation': 'Menzies Institute for Medical Research, College of Health and Medicine, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, College of Health and Medicine, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Schultz', 'Affiliation': 'Menzies Institute for Medical Research, College of Health and Medicine, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Sharman', 'Affiliation': 'Menzies Institute for Medical Research, College of Health and Medicine, University of Tasmania, Hobart, Tasmania, Australia James.Sharman@utas.edu.au.'}]",BMJ open,['10.1136/bmjopen-2020-036977']
1623,32714001,Evaluation of a Novel Trocar-Site Closure Device in Laparoscopic Surgery.,"Background and Objectives


We evaluated the effectiveness and safety of EZ-Close TM  compared to those of hand suture for trocar-site closure according to obesity.
Methods


Fifty-four cases of laparoscopic colorectal surgery were enrolled. For the same patient, the right port site was closed using EZ-Close TM  and left port site was closed by hand suture among cases with port-site diameter ≥10 mm. Cases switched to use of a conventional fascial closure device or with closure time 120 s were considered failures. Closure time was analyzed according to body mass index (BMI) and abdominal wall thickness (AWT).
Results


The mean closure time was significantly shorter with EZ-Close TM  than with hand suture (87.9 ± 21.0 vs. 128.0 ± 59.0 s,  p  < 0.001). The number of failure cases was significantly lower with EZ-Close TM  than with hand suture (7 vs. 27,  p  < 0.001). The closure time of EZ-Close TM  was significantly shorter than that of hand suture in patients with BMI ≥ 25 and < 27 kg/m 2  (n = 15, 85.9 ± 19.8 vs. 135.6 ± 67.9 s,  p  < 0.014) and ≥ 27 kg/m 2  (n = 13, 85.1 ± 18.4 vs. 150.2 ± 70.6 s,  p  < 0.010). With respect to AWT, the closure time of EZ-Close TM  was significantly shorter than that of hand suture in patients with AWT ≥ 20 and < 26 mm (n = 12, 81.1 ± 11.5 vs. 142.3 ± 83.7 s,  p  = 0.023) and ≥ 26 mm (n = 17, 85.6 ± 22.6 vs. 160.2 ± 55.5,  p  < 0.001). No infection and herniation were detected in both trocar sites during the follow-up period (median 20.4 months).
Conclusion


EZ-Close TM  could provide time efficiency in trocar-site closure, especially in obese patients.",2020,"No infection and herniation were detected in both trocar sites during the follow-up period (median 20.4 months).
","['obese patients', 'Methods\n\n\nFifty-four cases of laparoscopic colorectal surgery were enrolled', 'Laparoscopic Surgery']","['Novel Trocar-Site Closure Device', 'conventional fascial closure device', 'EZ-Close TM']","['number of failure cases', 'mean closure time', 'closure time of EZ-Close TM', 'No infection and herniation', 'Closure time', 'body mass index (BMI) and abdominal wall thickness (AWT']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0041158', 'cui_str': 'Trocar'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0587267', 'cui_str': 'Closed'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C2712105', 'cui_str': 'Absence of signs and symptoms of infection'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0836916', 'cui_str': 'Abdominal wall structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",,0.0446081,"No infection and herniation were detected in both trocar sites during the follow-up period (median 20.4 months).
","[{'ForeName': 'Youngbae', 'Initials': 'Y', 'LastName': 'Jeon', 'Affiliation': 'Department of Surgery, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Soohwa', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'Department of Biomedical Engineering, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Kyoung-Won', 'Initials': 'KW', 'LastName': 'Han', 'Affiliation': 'Department of Surgery, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Dong-Hyuk', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Biomedical Engineering, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Jeong-Heum', 'Initials': 'JH', 'LastName': 'Baek', 'Affiliation': 'Department of Surgery, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2020.00033']
1624,32717045,Association of Low-Dose Triple Combination Therapy With Therapeutic Inertia and Prescribing Patterns in Patients With Hypertension: A Secondary Analysis of the TRIUMPH Trial.,"Importance


Fixed-dose combination (FDC) therapies are being increasingly recommended for initial or early management of patients with hypertension, as they reduce treatment complexity and potentially reduce therapeutic inertia.
Objective


To investigate the association of antihypertensive triple drug FDC therapy with therapeutic inertia and prescribing patterns compared with usual care.
Design, Setting, and Participants


A post hoc analysis of the Triple Pill vs Usual Care Management for Patients With Mild-to-Moderate Hypertension (TRIUMPH) study, a randomized clinical trial of 700 patients with hypertension, was conducted. Patients were enrolled from 11 urban hospital clinics in Sri Lanka from February 2016 to May 2017; follow-up ended in October 2017. Data were analyzed from September to November 2019.
Interventions


Once-daily FDC antihypertensive pill (telmisartan, 20 mg; amlodipine, 2.5 mg; and chlorthalidone, 12.5 mg) or usual care.
Main Outcomes and Measures


Therapeutic inertia, defined as not intensifying therapy in those with blood pressure (BP) above target, was assessed at baseline and during follow-up visits. Prescribing patterns were characterized by BP-lowering drug class and treatment regimen potency. Predictors of therapeutic inertia were assessed with binomial logistic regression.
Results


Of the 700 included patients, 403 (57.6%) were female, and the mean (SD) age was 56 (11) years. Among patients who did not reach the BP target, therapeutic inertia was more common in the triple pill group compared with the usual care group at the week 6 visit (92 of 106 [86.8%] vs 124 of 194 [63.9%]; P < .001) and week 12 visit (81 of 90 [90%] vs 116 of 179 [64.8%]; P < .001). At the end of the study, 221 of 318 patients in the triple pill group (69.5%) and 182 of 329 patients in the usual care group (55.3%) reached BP targets. Among those who received treatment intensification, the increase in estimated regimen potency was greater in the triple pill group compared with the usual care group at baseline (predicted mean [SD] increase in regimen potency: triple pill, 15 [6] mm Hg; usual care, 10 [5] mm Hg; P < .001), whereas there were no significant differences at the week 6 or at week 12 visit. Clinic systolic BP level was the only consistent predictor of treatment intensification during follow-up. During follow-up, there were 23 vs 54 unique treatment regimens per 100 treated patients in the triple pill vs usual care groups, respectively (P < .001).
Conclusions and Relevance


Triple pill FDC therapy was associated with greater rates of therapeutic inertia compared with usual care. Despite this, triple pill FDC therapy substantially simplified prescribing patterns and improved 6-month BP control rates compared with usual care. Further improvements in hypertension control could be achieved by addressing therapeutic inertia among the minority of patients who do not achieve BP control after initial FDC therapy.
Trial Registration


ANZCTR Identifier: ACTRN12612001120864.",2020,"Despite this, triple pill FDC therapy substantially simplified prescribing patterns and improved 6-month BP control rates compared with usual care.","['700 patients with hypertension', '700 included patients, 403 (57.6%) were female, and the mean (SD) age was 56 (11) years', '318 patients in the triple pill group (69.5%) and 182 of 329 patients in the usual care group (55.3%) reached BP targets', 'Patients With Hypertension', 'patients with hypertension', 'Patients were enrolled from 11 urban hospital clinics in Sri Lanka from February 2016 to May 2017; follow-up ended in October 2017', 'Patients With Mild-to-Moderate Hypertension (TRIUMPH']","['Low-Dose Triple Combination Therapy', 'Triple Pill vs Usual Care Management', 'antihypertensive triple drug FDC therapy', 'FDC antihypertensive pill (telmisartan, 20 mg; amlodipine, 2.5 mg; and chlorthalidone, 12.5 mg) or usual care', 'Importance\n\n\nFixed-dose combination (FDC) therapies']","['6-month BP control rates', 'rates of therapeutic inertia', 'estimated regimen potency', 'blood pressure (BP', 'Clinic systolic BP level', 'BP target, therapeutic inertia']","[{'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0020029', 'cui_str': 'Urban Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0038088', 'cui_str': 'Sri Lanka'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C3643615', 'cui_str': 'Triumph'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0008294', 'cui_str': 'Chlorthalidone'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",700.0,0.0588462,"Despite this, triple pill FDC therapy substantially simplified prescribing patterns and improved 6-month BP control rates compared with usual care.","[{'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Salam', 'Affiliation': 'The George Institute for Global Health, New Delhi, India.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Webster', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Asita', 'Initials': 'A', 'LastName': 'de Silva', 'Affiliation': 'Clinical Trials Unit, Department of Pharmacology, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka.'}, {'ForeName': 'Rama', 'Initials': 'R', 'LastName': 'Guggilla', 'Affiliation': 'Division of Dentistry, Division of Medical Education in English, Department of Population Medicine and Civilization Diseases Prevention, Faculty of Medicine, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Stepien', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Jayanthi', 'Initials': 'J', 'LastName': 'Mysore', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jan', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Pallab K', 'Initials': 'PK', 'LastName': 'Maulik', 'Affiliation': 'The George Institute for Global Health, New Delhi, India.'}, {'ForeName': 'Nitish', 'Initials': 'N', 'LastName': 'Naik', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Selak', 'Affiliation': 'Department of Epidemiology and Biostatistics, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Thom', 'Affiliation': 'Department of Epidemiology and Biostatistics, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Dorairaj', 'Initials': 'D', 'LastName': 'Prabhakaran', 'Affiliation': 'Centre for Chronic Disease Control and Public Health Foundation, New Delhi, India.'}, {'ForeName': 'Anushka', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rodgers', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA cardiology,['10.1001/jamacardio.2020.2739']
1625,32717350,A sequential multiple assignment randomized trial (SMART) protocol for empirically developing an adaptive preventive intervention for college student drinking reduction.,"College student alcohol use and associated negative consequences are clear public health problems with consequences including damage to self, others, and institutions. This paper describes the protocol of a research study designed to answer a number of important questions in the development of an adaptive preventive intervention (API) to reduce high-risk drinking among first-year college students. The API is designed to educate students and to motivate heavy-drinking college students to engage in existing resources to support reducing high-risk alcohol use, by leveraging technology-based intervention modalities. The primary outcome is a reduction in binge drinking, with secondary outcomes of reducing negative alcohol-related consequences and increasing health services utilization. Adaptive preventive interventions have the potential to reduce the acute and long-term negative health consequences of young adult alcohol use.",2020,"The primary outcome is a reduction in binge drinking, with secondary outcomes of reducing negative alcohol-related consequences and increasing health services utilization.","['college student drinking reduction', 'first-year college students']",['adaptive preventive intervention (API'],"['reduction in binge drinking, with secondary outcomes of reducing negative alcohol-related consequences and increasing health services utilization']","[{'cui': 'C4042862', 'cui_str': 'Alcohol Drinking, College Students'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}]",,0.0187936,"The primary outcome is a reduction in binge drinking, with secondary outcomes of reducing negative alcohol-related consequences and increasing health services utilization.","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Patrick', 'Affiliation': ""Institute for Translational Research in Children's Mental Health, University of Minnesota, 1100 Washington Avenue South, Suite 101, Minneapolis, MN 55415, USA. Electronic address: mpatrick@umn.edu.""}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Boatman', 'Affiliation': 'Division of Biostatistics, University of Minnesota, 420 Delaware Street Southeast, MMC 303 Mayo, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Morrell', 'Affiliation': ""Institute for Translational Research in Children's Mental Health, University of Minnesota, 1100 Washington Avenue South, Suite 101, Minneapolis, MN 55415, USA.""}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Wagner', 'Affiliation': ""Institute for Translational Research in Children's Mental Health, University of Minnesota, 1100 Washington Avenue South, Suite 101, Minneapolis, MN 55415, USA.""}, {'ForeName': 'Grace R', 'Initials': 'GR', 'LastName': 'Lyden', 'Affiliation': 'Division of Biostatistics, University of Minnesota, 420 Delaware Street Southeast, MMC 303 Mayo, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Nahum-Shani', 'Affiliation': 'Institute for Social Research, University of Michigan, P.O. Box 1248, 426 Thompson Street, Ann Arbor, MI 48106, USA.'}, {'ForeName': 'Cheryl A', 'Initials': 'CA', 'LastName': 'King', 'Affiliation': 'Department of Psychiatry, University of Michigan, 4250 Plymouth Road, Room 2129, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Bonar', 'Affiliation': 'Department of Psychiatry, University of Michigan, 4250 Plymouth Road, Room 2129, Ann Arbor, MI 48109, USA; Injury Prevention Center, University of Michigan, 2800 Plymouth Road, NCRC Building 10, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for the Study of Health and Risk Behaviors, University of Washington, 1100 Northeast 45(th) Street, Suite 300, Seattle, WA 98105, USA.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Larimer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for the Study of Health and Risk Behaviors, University of Washington, 1100 Northeast 45(th) Street, Suite 300, Seattle, WA 98105, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Vock', 'Affiliation': 'Division of Biostatistics, University of Minnesota, 420 Delaware Street Southeast, MMC 303 Mayo, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Almirall', 'Affiliation': 'Institute for Social Research, University of Michigan, P.O. Box 1248, 426 Thompson Street, Ann Arbor, MI 48106, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106089']
1626,32717448,"Analgesic efficacy of ultrasound guided bilateral transversus thoracis muscle plane block in pediatric cardiac surgery: a randomized, double-blind, controlled study.","STUDY OBJECTIVE


Adequate perioperative pain control in children undergoing cardiac surgery is mandatory. Intravenous opioids and neuraxial anesthetic techniques have been used but didn't gained any popularity. The aim of the current study was to evaluate the analgesic efficacy of transversus thoracis plane (TTP) block in pediatric cardiac surgery.
DESIGN


Superiority, randomized, double-blind, controlled study.
SETTING


Intraoperative and postoperative in intensive care unit (ICU), Mansoura university children hospital, Egypt.
PATIENTS


Eighty pediatric patients aged 2-12 years, undergoing cardiac surgery via median sternotomy, were randomly allocated into 2 equal groups, the control group and TTP block group.
INTERVENTIONS


Controlled group received only fentanyl for perioperative analgesia, while TTP block was performed in the intervention group (TTP group).
MEASUREMENTS


The primary outcome measure was the total dose of fentanyl in the first postoperative 24 h after extubation, while the secondary outcome measures were postoperative pain score, intraoperative fentanyl consumption, time to extubation and ICU length of stay.
MAIN RESULTS


During the first postoperative 24 h, total fentanyl consumption was significantly lower (P < 0.05) in the TTP block group (9.892 ± 3.397 μg/kg) than the control group (18.500 ± 3.401 μg/kg) and modified objective pain score was significantly (P < 0.05) lower in TTP block group than the control group all over the time. Total intraoperative fentanyl requirement was significantly (P < 0.05) lower in TTP block group (8.27 ± 1.170 μg/kg) than the control group (13.72 ± 1.186 μg/kg).
CONCLUSION


The use of TTP block decreased perioperative fentanyl consumption and reduced postoperative pain intensity.",2020,"Total intraoperative fentanyl requirement was significantly (P < 0.05) lower in TTP block group (8.27 ± 1.170 μg/kg) than the control group (13.72 ± 1.186 μg/kg).
","['children undergoing cardiac surgery', 'Intraoperative and postoperative in intensive care unit (ICU), Mansoura university children hospital, Egypt', 'Eighty pediatric patients aged 2-12\xa0years, undergoing cardiac surgery via median sternotomy', 'pediatric cardiac surgery']","['TTP block', 'transversus thoracis plane (TTP) block', 'fentanyl for perioperative analgesia, while TTP block was performed in the intervention group (TTP group', 'control group and TTP block group', 'ultrasound guided bilateral transversus thoracis muscle plane block']","['postoperative pain intensity', 'modified objective pain score', 'perioperative fentanyl consumption', 'Analgesic efficacy', 'analgesic efficacy', 'total fentanyl consumption', 'Total intraoperative fentanyl requirement', 'postoperative pain score, intraoperative fentanyl consumption, time to extubation and ICU length of stay', 'total dose of fentanyl in the first postoperative 24\xa0h after extubation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1282959', 'cui_str': 'Median sternotomy'}]","[{'cui': 'C1744608', 'cui_str': 'Structure of transverse thoracis muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1096288', 'cui_str': 'Perioperative analgesia'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",80.0,0.408484,"Total intraoperative fentanyl requirement was significantly (P < 0.05) lower in TTP block group (8.27 ± 1.170 μg/kg) than the control group (13.72 ± 1.186 μg/kg).
","[{'ForeName': 'Ibrahim I', 'Initials': 'II', 'LastName': 'Abdelbaser', 'Affiliation': 'Department of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Mansoura University, 2 El-Gomhouria St, Mansoura 35516, Egypt. Electronic address: ibraheem2005@mans.edu.eg.'}, {'ForeName': 'Nabil A', 'Initials': 'NA', 'LastName': 'Mageed', 'Affiliation': 'Department of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Mansoura University, 2 El-Gomhouria St, Mansoura 35516, Egypt.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110002']
1627,32717684,"Switching to fingolimod in PREFERMS: Effect of treatment history and naïvety on clinical, MRI and treatment satisfaction outcomes ✰ .","BACKGROUND


Injectable disease-modifying therapies (iDMTs) are often used as first-line treatments for relapsing multiple sclerosis. Fingolimod is frequently used following treatment with iDMTs. Whether prior iDMT treatment impacts the effectiveness of subsequent fingolimod therapy is unclear. Here, we assessed switching from iDMTs to fingolimod, and the impact of treatment history on fingolimod escalation using data from the 12-month 'Prospective, Randomized, active-controlled, open-label study to Evaluate patient retention on Fingolimod versus approved first-line disease-modifying thErapies in adults with Relapsing-remitting Multiple Sclerosis' (PREFERMS). The study design and results at the end of randomized treatment (EoRT) in PREFERMS have been published.
METHODS


Both treatment-naïve patients and those who had previously received an iDMT were eligible for enrolment in PREFERMS, and one treatment switch was permitted on study. Pre-specified exploratory analyses compared outcomes in those randomized to fingolimod or to an iDMT at end of study (EoS), which included time spent on randomized and on switch treatment. Post hoc exploratory analyses (unadjusted for multiplicity owing to the large number of comparisons) among patients randomized to an iDMT who switched to fingolimod, compared outcomes longitudinally before (EoRT) and after (EoS) switching, and compared outcomes at EoRT and EoS among subgroups stratified by iDMT-treatment history. Outcomes included brain volume, various measures of gadolinium-enhancing [Gd+] lesion counts, annualized relapse rate (ARR), Symbol Digit Modalities Test (SDMT) score, patient-reported treatment satisfaction using the Medication Satisfaction Questionnaire (MSQ) and adverse event (AE) rates.
RESULTS


At EoS, 255 of 439 patients randomized to an iDMT had switched to fingolimod and 27 of 436 patients randomized to fingolimod had switched to an iDMT. By EoS, 44.2% of total treatment exposure in the iDMT group was to fingolimod and the mean time spent on fingolimod in this group was 220 days (approximately 7 months). Outcomes in the fingolimod group at EoS (brain volume, changes in Gd+ lesion counts, ARR, oral SDMT score and MSQ score) were similar to those seen at EoRT, but in the iDMT group these outcomes were more favorable at EoS than at EoRT and were similar to rates seen in the fingolimod group. Among patients who switched from iDMT to fingolimod, there were longitudinal improvements in ARR (EoRT, 0.3 [95% confidence interval (CI), 0.2-0.4]; EoS, 0.2 [0.1-0.3]; odds ratio, 0.5 [0.3-0.9]) and in treatment satisfaction (proportion of patients with MSQ > 5; EoRT, 67.4%; EoS, 90.4%; odds ratio, 5.7 [95% CI, 3.4-9.4]) after fingolimod treatment, and changes in brain volume, Gd+ lesion count, and AEs or AEs causing discontinuation were also more favorable at EoS than at EoRT. In all patient groups stratified by iDMT-treatment history, differences in outcomes narrowed or disappeared after fingolimod treatment.
CONCLUSION


These analyses indicate that patients in PREFERMS had improved outcomes within months of switching to fingolimod from an iDMT and that improvements occurred irrespective of the number of iDMTs previously administered. These data provide a unique opportunity to explore clinical, radiological and safety outcomes associated with a range of clinically relevant treatment pathways.",2020,"In all patient groups stratified by iDMT-treatment history, differences in outcomes narrowed or disappeared after fingolimod treatment.
","['At EoS, 255 of 439 patients randomized to an iDMT had switched to fingolimod and 27 of 436 patients randomized to', 'Both treatment-naïve patients and those who had previously received an iDMT were eligible for enrolment in PREFERMS, and one treatment switch was permitted on study', ""adults with Relapsing-remitting Multiple Sclerosis' (PREFERMS""]","['fingolimod had switched to an iDMT', 'Fingolimod versus approved first-line disease-modifying thErapies']","['EoS (brain volume, changes in Gd+ lesion counts, ARR, oral SDMT score and MSQ score', 'mean time spent on fingolimod', 'brain volume, various measures of gadolinium-enhancing [Gd+] lesion counts, annualized relapse rate (ARR), Symbol Digit Modalities Test (SDMT) score, patient-reported treatment satisfaction using the Medication Satisfaction Questionnaire (MSQ) and adverse event (AE) rates', 'longitudinal improvements in ARR', 'brain volume, Gd+ lesion count, and AEs or AEs causing discontinuation']","[{'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}]","[{'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0451522', 'cui_str': 'Symbol digit modalities test'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",439.0,0.0609136,"In all patient groups stratified by iDMT-treatment history, differences in outcomes narrowed or disappeared after fingolimod treatment.
","[{'ForeName': 'Samuel F', 'Initials': 'SF', 'LastName': 'Hunter', 'Affiliation': 'Advanced Neurosciences Institute, 101 Forrest Crossing Blvd. Suite 103, Franklin, TN 37064, United States. Electronic address: sfhunter@neurosci.us.'}, {'ForeName': 'Florian P', 'Initials': 'FP', 'LastName': 'Thomas', 'Affiliation': 'Hackensack Meridian School of Medicine at Seton Hall University, South Orange, and Hackensack University Medical Center, Hackensack, NJ, United States. Electronic address: florian.thomas@hackensackmeridian.org.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cascione', 'Affiliation': 'Tampa Neurology Associates, Tampa, FL, United States. Electronic address: me@markcascione.com.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Williams', 'Affiliation': 'Oxford PharmaGenesis, Oxford, United Kingdom. Electronic address: ian.williams@pharmagenesis.com.'}, {'ForeName': 'Xiangyi', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States. Electronic address: xiangyi.meng@novartis.com.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Schofield', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States. Electronic address: lesley.schofield@novartis.com.'}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Weiss', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States. Electronic address: jamie.weiss@novartis.com.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Tenenbaum', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States. Electronic address: nadia.tenebaum@novartis.com.'}, {'ForeName': 'Bruce A C', 'Initials': 'BAC', 'LastName': 'Cree', 'Affiliation': 'UCSF Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, United States. Electronic address: bruce.cree@ucsf.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102346']
1628,32718922,"PROMISE (Program Refinements to Optimize Model Impact and Scalability based on Evidence): a cluster-randomised, stepped-wedge trial assessing effectiveness of the revised versus original Ryan White Part A HIV Care Coordination Programme for patients with barriers to treatment in the USA.","INTRODUCTION


Growing evidence supports combining social, behavioural and biomedical strategies to strengthen the HIV care continuum. However, combination interventions can be resource-intensive and challenging to scale up. Research is needed to identify intervention components and delivery models that maximise uptake, engagement and effectiveness. In New York City (NYC), a multicomponent Ryan White Part A-funded medical case management intervention called the Care Coordination Programme (CCP) was launched at 28 agencies in 2009 in order to address barriers to care and treatment. Effectiveness estimates based on >7000 clients enrolled by April 2013 and their controls indicated modest CCP benefits over 'usual care' for short-term and long-term viral suppression, with substantial room for improvement.
METHODS AND ANALYSIS


Integrating evaluation findings and CCP service-provider and community-stakeholder input on modifications, the NYC Health Department packaged a Care Coordination Redesign (CCR) in a 2017 request for proposals. Following competitive re-solicitation, 17 of the original CCP-implementing agencies secured contracts. These agencies were randomised within matched pairs to immediate or delayed CCR implementation. Data from three 9-month periods (pre-implementation, partial implementation and full implementation) will be examined to compare CCR versus CCP effects on timely viral suppression (TVS, within 4 months of enrolment) among individuals with unsuppressed HIV viral load newly enrolling in the CCR/CCP. Based on current enrolment (n=933) and the pre-implementation outcome probability (TVS=0.54), the detectable effect size with 80% power is an OR of 2.75 (relative risk: 1.41).
ETHICS AND DISSEMINATION


This study was approved by the NYC Department of Health and Mental Hygiene Institutional Review Board (IRB, Protocol 18-009) and the City University of New York Integrated IRB (Protocol 018-0057) with a waiver of informed consent. Findings will be disseminated via publications, conferences, stakeholder meetings, and Advisory Board meetings with implementing agency representatives.
TRIAL REGISTRATION NUMBER


Registered with ClinicalTrials.gov under identifier: NCT03628287, V.2, 25 September 2019; pre-results.",2020,"Effectiveness estimates based on >7000 clients enrolled by April 2013 and their controls indicated modest CCP benefits over 'usual care' for short-term and long-term viral suppression, with substantial room for improvement.
","['patients with barriers to treatment in the USA', 'individuals with unsuppressed HIV viral load newly enrolling in the CCR/CCP', 'NYC Department of Health and Mental Hygiene Institutional Review Board (IRB, Protocol 18-009) and the City University of New York Integrated IRB', ""7000 clients enrolled by April 2013 and their controls indicated modest CCP benefits over 'usual care' for short-term and long-term viral suppression, with substantial room for improvement""]",['CCP service-provider and community-stakeholder input on modifications'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C4708914', 'cui_str': '7000'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205136', 'cui_str': 'Over'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",[],7000.0,0.0888393,"Effectiveness estimates based on >7000 clients enrolled by April 2013 and their controls indicated modest CCP benefits over 'usual care' for short-term and long-term viral suppression, with substantial room for improvement.
","[{'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Irvine', 'Affiliation': 'Bureau of HIV, New York City Department of Health and Mental Hygiene, Queens, New York, USA mirvine@health.nyc.gov.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Levin', 'Affiliation': 'Department of Biostatistics, Mailman School of Public Health (MSPH), Columbia University, New York, New York, USA.'}, {'ForeName': 'McKaylee M', 'Initials': 'MM', 'LastName': 'Robertson', 'Affiliation': 'Institute for Implementation Science in Population Health, Graduate School of Public Health and Health Policy, City University of New York, New York, New York, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Penrose', 'Affiliation': 'Bureau of HIV, New York City Department of Health and Mental Hygiene, Queens, New York, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Carmona', 'Affiliation': 'Bureau of HIV, New York City Department of Health and Mental Hygiene, Queens, New York, USA.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Harriman', 'Affiliation': 'Bureau of HIV, New York City Department of Health and Mental Hygiene, Queens, New York, USA.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Braunstein', 'Affiliation': 'Bureau of HIV, New York City Department of Health and Mental Hygiene, Queens, New York, USA.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Nash', 'Affiliation': 'Institute for Implementation Science in Population Health, Graduate School of Public Health and Health Policy, City University of New York, New York, New York, USA.'}]",BMJ open,['10.1136/bmjopen-2019-034624']
1629,32718924,Implementation of blood glucose self-monitoring among insulin-dependent patients with type 2 diabetes in three rural districts in Rwanda: 6 months open randomised controlled trial.,"INTRODUCTION


Most patients diagnosed with diabetes in sub-Saharan Africa (SSA) present with poorly controlled blood glucose, which is associated with increased risks of complications and greater financial burden on both the patients and health systems. Insulin-dependent patients with diabetes in SSA lack appropriate home-based monitoring technology to inform themselves and clinicians of the daily fluctuations in blood glucose. Without sufficient home-based data, insulin adjustments are not data driven and adopting individual behavioural change for glucose control in SSA does not have a systematic path towards improvement.
METHODS AND ANALYSIS


This study explores the feasibility and impact of implementing self-monitoring of blood glucose (SMBG) in patients with type 2 diabetes in rural Rwandan districts. This is an open randomised controlled trial comprising of two arms: (1) Intervention group-participants will receive a glucose metre, blood test strips, logbook, waste management box and training on how to conduct SMBG in additional to usual care and (2) Control group-participants will receive usual care, comprising of clinical consultations and routine monthly follow-up. We will conduct qualitative interviews at enrolment and at the end of the study to assess knowledge of diabetes. At the end of the study period, we will interview clinicians and participants to assess the perceived usefulness, facilitators and barriers of SMBG. The primary outcomes are change in haemoglobin A1c, fidelity to SMBG protocol by patients, appropriateness and adverse effects resulting from SMBG. Secondary outcomes include reliability and acceptability of SMBG and change in the quality of life of the participants.
ETHICS AND DISSEMINATION


This study has been approved by the Rwanda National Ethics Committee (Kigali, Rwanda No.102/RNEC/2018). We will disseminate the findings of this study through presentations within our study settings, scientific conferences and publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


PACTR201905538846394; pre-results.",2020,"The primary outcomes are change in haemoglobin A1c, fidelity to SMBG protocol by patients, appropriateness and adverse effects resulting from SMBG.","['dependent patients with type 2 diabetes in three rural districts in Rwanda', 'patients diagnosed with diabetes in sub-Saharan Africa (SSA', 'patients with type 2 diabetes in rural Rwandan districts']","['Intervention group-participants will receive a glucose metre, blood test strips, logbook, waste management box and training on how to conduct SMBG in additional to usual care and (2) Control group-participants will receive usual care, comprising of clinical consultations and routine monthly follow-up', 'blood glucose self-monitoring among insulin', 'implementing self-monitoring of blood glucose (SMBG']","['change in haemoglobin A1c, fidelity to SMBG protocol by patients, appropriateness and adverse effects resulting from SMBG', 'reliability and acceptability of SMBG and change in the quality of life of the participants']","[{'cui': 'C0581116', 'cui_str': 'Dependent patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0475209', 'cui_str': 'meter'}, {'cui': 'C0462899', 'cui_str': 'Blood testing strips'}, {'cui': 'C0242716', 'cui_str': 'Waste Management'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0961424,"The primary outcomes are change in haemoglobin A1c, fidelity to SMBG protocol by patients, appropriateness and adverse effects resulting from SMBG.","[{'ForeName': 'Loise', 'Initials': 'L', 'LastName': ""Ng'ang'a"", 'Affiliation': 'Research, Inshuti Mu Buzima, Partners In Health-Rwanda, Rwinkwavu, Rwanda loisehaks@gmail.com.'}, {'ForeName': 'Gedeon', 'Initials': 'G', 'LastName': 'Ngoga', 'Affiliation': 'Non-Communicable Diseases Division, Rwanda Biomedical Center, Kigali, Rwanda.'}, {'ForeName': 'Symaque', 'Initials': 'S', 'LastName': 'Dusabeyezu', 'Affiliation': 'Research, Inshuti Mu Buzima, Partners In Health-Rwanda, Rwinkwavu, Rwanda.'}, {'ForeName': 'Bethany L', 'Initials': 'BL', 'LastName': 'Hedt-Gauthier', 'Affiliation': 'Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Patient', 'Initials': 'P', 'LastName': 'Ngamije', 'Affiliation': 'Kirehe District Hospital, Ministry of Health, Kigali, Rwanda.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Habiyaremye', 'Affiliation': 'Rwinkwavu District Hospital, Ministry of Health, Kigali, Rwanda.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Harerimana', 'Affiliation': 'Research, Inshuti Mu Buzima, Partners In Health-Rwanda, Rwinkwavu, Rwanda.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Ndayisaba', 'Affiliation': 'Non-Communicable Diseases Division, Rwanda Biomedical Center, Kigali, Rwanda.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rusangwa', 'Affiliation': 'Research, Inshuti Mu Buzima, Partners In Health-Rwanda, Rwinkwavu, Rwanda.'}, {'ForeName': 'Simon Pierre', 'Initials': 'SP', 'LastName': 'Niyonsenga', 'Affiliation': 'Non-Communicable Diseases Division, Rwanda Biomedical Center, Kigali, Rwanda.'}, {'ForeName': 'Charlotte M', 'Initials': 'CM', 'LastName': 'Bavuma', 'Affiliation': 'Internal Medicine, University of Rwanda College of Medicine and Health Sciences, Kigali, Rwanda.'}, {'ForeName': 'Gene', 'Initials': 'G', 'LastName': 'Bukhman', 'Affiliation': 'NCD Synergies, Partners in Health, Boston, Massachusetts, United States.'}, {'ForeName': 'Alma J', 'Initials': 'AJ', 'LastName': 'Adler', 'Affiliation': 'Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Fredrick', 'Initials': 'F', 'LastName': 'Kateera', 'Affiliation': 'Research, Inshuti Mu Buzima, Partners In Health-Rwanda, Rwinkwavu, Rwanda.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Park', 'Affiliation': 'NCD Synergies, Partners in Health, Boston, Massachusetts, United States.'}]",BMJ open,['10.1136/bmjopen-2019-036202']
1630,32719355,Preferential inhibition of adaptive immune system dynamics by glucocorticoids in patients after acute surgical trauma.,"Glucocorticoids (GC) are a controversial yet commonly used intervention in the clinical management of acute inflammatory conditions, including sepsis or traumatic injury. In the context of major trauma such as surgery, concerns have been raised regarding adverse effects from GC, thereby necessitating a better understanding of how GCs modulate the immune response. Here we report the results of a randomized controlled trial (NCT02542592) in which we employ a high-dimensional mass cytometry approach to characterize innate and adaptive cell signaling dynamics after a major surgery (primary outcome) in patients treated with placebo or methylprednisolone (MP). A robust, unsupervised bootstrap clustering of immune cell subsets coupled with random forest analysis shows profound (AUC = 0.92, p-value = 3.16E-8) MP-induced alterations of immune cell signaling trajectories, particularly in the adaptive compartments. By contrast, key innate signaling responses previously associated with pain and functional recovery after surgery, including STAT3 and CREB phosphorylation, are not affected by MP. These results imply cell-specific and pathway-specific effects of GCs, and also prompt future studies to examine GCs' effects on clinical outcomes likely dependent on functional adaptive immune responses.",2020,"A robust, unsupervised bootstrap clustering of immune cell subsets coupled with random forest analysis shows profound (AUC = 0.92, p-value = 3.16E-8) MP-induced alterations of immune cell signaling trajectories, particularly in the adaptive compartments.","['patients treated with', 'patients after acute surgical trauma']","['Glucocorticoids (GC', 'placebo or methylprednisolone (MP', 'glucocorticoids']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]","[{'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]",[],,0.170748,"A robust, unsupervised bootstrap clustering of immune cell subsets coupled with random forest analysis shows profound (AUC = 0.92, p-value = 3.16E-8) MP-induced alterations of immune cell signaling trajectories, particularly in the adaptive compartments.","[{'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Ganio', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Stanley', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Viktoria', 'Initials': 'V', 'LastName': 'Lindberg-Larsen', 'Affiliation': 'The Lundbeck Foundation Center for Fast-track Hip and Knee replacement, Copenhagen, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Einhaus', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Tsai', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Verdonk', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Culos', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Gahemi', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Kristen K', 'Initials': 'KK', 'LastName': 'Rumer', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Ina A', 'Initials': 'IA', 'LastName': 'Stelzer', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Dyani', 'Initials': 'D', 'LastName': 'Gaudilliere', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Tsai', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Fallahzadeh', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Choisy', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Kehlet', 'Affiliation': 'Section of Surgical Pathophysiology 7621, Rigshospitalet, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Aghaeepour', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Angst', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Brice', 'Initials': 'B', 'LastName': 'Gaudilliere', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA. gbrice@stanford.edu.'}]",Nature communications,['10.1038/s41467-020-17565-y']
1631,32719399,Controlling technical variation amongst 6693 patient microarrays of the randomized MINDACT trial.,"Gene expression data obtained in large studies hold great promises for discovering disease signatures or subtypes through data analysis. It is also prone to technical variation, whose removal is essential to avoid spurious discoveries. Because this variation is not always known and can be confounded with biological signals, its removal is a challenging task. Here we provide a step-wise procedure and comprehensive analysis of the MINDACT microarray dataset. The MINDACT trial enrolled 6693 breast cancer patients and prospectively validated the gene expression signature MammaPrint for outcome prediction. The study also yielded a full-transcriptome microarray for each tumor. We show for the first time in such a large dataset how technical variation can be removed while retaining expected biological signals. Because of its unprecedented size, we hope the resulting adjusted dataset will be an invaluable tool to discover or test gene expression signatures and to advance our understanding of breast cancer.",2020,The MINDACT trial enrolled 6693 breast cancer patients and prospectively validated the gene expression signature MammaPrint for outcome prediction.,"['6693 breast cancer patients', '6693 patient microarrays']",[],[],"[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],[],6693.0,0.0324953,The MINDACT trial enrolled 6693 breast cancer patients and prospectively validated the gene expression signature MammaPrint for outcome prediction.,"[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Jacob', 'Affiliation': 'Université de Lyon, Université Lyon 1, CNRS, Laboratoire de Biométrie et Biologie Évolutive UMR 5558, Villeurbanne, France.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Witteveen', 'Affiliation': 'Agendia NV/Agendia Inc, Amsterdam, The Netherlands.'}, {'ForeName': 'Inès', 'Initials': 'I', 'LastName': 'Beumer', 'Affiliation': 'Agendia NV/Agendia Inc, Amsterdam, The Netherlands.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Delahaye', 'Affiliation': 'Agendia NV/Agendia Inc, Amsterdam, The Netherlands.'}, {'ForeName': 'Diederik', 'Initials': 'D', 'LastName': 'Wehkamp', 'Affiliation': 'Agendia NV/Agendia Inc, Amsterdam, The Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'van den Akker', 'Affiliation': 'Agendia NV/Agendia Inc, Amsterdam, The Netherlands.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Snel', 'Affiliation': 'Agendia NV/Agendia Inc, Amsterdam, The Netherlands.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Chan', 'Affiliation': 'Agendia NV/Agendia Inc, Amsterdam, The Netherlands.'}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'Floore', 'Affiliation': 'Agendia NV/Agendia Inc, Amsterdam, The Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Bakx', 'Affiliation': 'Agendia NV/Agendia Inc, Amsterdam, The Netherlands.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Brink', 'Affiliation': 'Agendia NV/Agendia Inc, Amsterdam, The Netherlands.'}, {'ForeName': 'Coralie', 'Initials': 'C', 'LastName': 'Poncet', 'Affiliation': 'EORTC, Brussels, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bogaerts', 'Affiliation': 'EORTC, Brussels, Belgium.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Delorenzi', 'Affiliation': 'University Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Piccart', 'Affiliation': 'Institute Jules Bordet, Brussels, Belgium.'}, {'ForeName': 'Emiel', 'Initials': 'E', 'LastName': 'Rutgers', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Cardoso', 'Affiliation': 'Champalimaud, Lisbon, Portugal.'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Speed', 'Affiliation': 'Walter and Eliza Hall Institute of Medical Research, Melbourne, VIC, Australia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': ""van 't Veer"", 'Affiliation': 'Agendia NV/Agendia Inc, Amsterdam, The Netherlands. Laura.Vantveer@ucsf.edu.'}, {'ForeName': 'Annuska', 'Initials': 'A', 'LastName': 'Glas', 'Affiliation': 'Agendia NV/Agendia Inc, Amsterdam, The Netherlands. annuska.glas@agendia.com.'}]",Communications biology,['10.1038/s42003-020-1111-1']
1632,32721007,Association of Menopausal Hormone Therapy With Breast Cancer Incidence and Mortality During Long-term Follow-up of the Women's Health Initiative Randomized Clinical Trials.,"Importance


The influence of menopausal hormone therapy on breast cancer remains unsettled with discordant findings from observational studies and randomized clinical trials.
Objective


To assess the association of prior randomized use of estrogen plus progestin or prior randomized use of estrogen alone with breast cancer incidence and mortality in the Women's Health Initiative clinical trials.
Design, Setting, and Participants


Long-term follow-up of 2 placebo-controlled randomized clinical trials that involved 27 347 postmenopausal women aged 50 through 79 years with no prior breast cancer and negative baseline screening mammogram. Women were enrolled at 40 US centers from 1993 to 1998 with follow-up through December 31, 2017.
Interventions


In the trial involving 16 608 women with a uterus, 8506 were randomized to receive 0.625 mg/d of conjugated equine estrogen (CEE) plus 2.5 mg/d of medroxyprogesterone acetate (MPA) and 8102, placebo. In the trial involving 10 739 women with prior hysterectomy, 5310 were randomized to receive 0.625 mg/d of CEE alone and 5429, placebo. The CEE-plus-MPA trial was stopped in 2002 after 5.6 years' median intervention duration, and the CEE-only trial was stopped in 2004 after 7.2 years' median intervention duration.
Main Outcomes and Measures


The primary outcome was breast cancer incidence (protocol prespecified primary monitoring outcome for harm) and secondary outcomes were deaths from breast cancer and deaths after breast cancer.
Results


Among 27 347 postmenopausal women who were randomized in both trials (baseline mean [SD] age, 63.4 years [7.2 years]), after more than 20 years of median cumulative follow-up, mortality information was available for more than 98%. CEE alone compared with placebo among 10 739 women with a prior hysterectomy was associated with statistically significantly lower breast cancer incidence with 238 cases (annualized rate, 0.30%) vs 296 cases (annualized rate, 0.37%; hazard ratio [HR], 0.78; 95% CI, 0.65-0.93; P = .005) and was associated with statistically significantly lower breast cancer mortality with 30 deaths (annualized mortality rate, 0.031%) vs 46 deaths (annualized mortality rate, 0.046%; HR, 0.60; 95% CI, 0.37-0.97; P = .04). In contrast, CEE plus MPA compared with placebo among 16 608 women with a uterus was associated with statistically significantly higher breast cancer incidence with 584 cases (annualized rate, 0.45%) vs 447 cases (annualized rate, 0.36%; HR, 1.28; 95% CI, 1.13-1.45; P < .001) and no significant difference in breast cancer mortality with 71 deaths (annualized mortality rate, 0.045%) vs 53 deaths (annualized mortality rate, 0.035%; HR, 1.35; 95% CI, 0.94-1.95; P= .11).
Conclusions and Relevance


In this long-term follow-up study of 2 randomized trials, prior randomized use of CEE alone, compared with placebo, among women who had a previous hysterectomy, was significantly associated with lower breast cancer incidence and lower breast cancer mortality, whereas prior randomized use of CEE plus MPA, compared with placebo, among women who had an intact uterus, was significantly associated with a higher breast cancer incidence but no significant difference in breast cancer mortality.",2020,"CEE alone compared with placebo among 10 739 women with a prior hysterectomy was associated with statistically significantly lower breast cancer incidence with 238 cases (annualized rate, 0.30%) vs 296 cases (annualized rate, 0.37%; hazard ratio [HR], 0.78; 95% CI, 0.65-0.93; P = .005) and was associated with statistically significantly lower breast cancer mortality with 30 deaths (annualized mortality rate, 0.031%) vs 46 deaths (annualized mortality rate, 0.046%; HR, 0.60; 95% CI, 0.37-0.97; P = .04).","['10\u202f739 women with prior hysterectomy, 5310', '27\u202f347 postmenopausal women aged 50 through 79 years with no prior breast cancer and negative baseline screening mammogram', 'Women were enrolled at 40 US centers from 1993 to 1998 with follow-up through December 31, 2017', '16\u202f608 women with a uterus, 8506', '27\u202f347 postmenopausal women who were randomized in both trials (baseline mean [SD] age, 63.4 years [7.2 years']","['estrogen alone', 'CEE plus MPA', 'conjugated equine estrogen (CEE) plus 2.5 mg/d of medroxyprogesterone acetate (MPA) and 8102, placebo', 'CEE', 'CEE alone and 5429, placebo', 'menopausal hormone therapy', 'Menopausal Hormone Therapy', 'estrogen plus progestin', 'placebo']","['median cumulative follow-up, mortality information', 'breast cancer mortality', 'lower breast cancer incidence and lower breast cancer mortality', 'breast cancer incidence', 'Mortality', 'breast cancer incidence (protocol prespecified primary monitoring outcome for harm) and secondary outcomes were deaths from breast cancer and deaths after breast cancer']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517857', 'cui_str': '7.2'}]","[{'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}, {'cui': 'C0033306', 'cui_str': 'Progestational hormone'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",16608.0,0.242551,"CEE alone compared with placebo among 10 739 women with a prior hysterectomy was associated with statistically significantly lower breast cancer incidence with 238 cases (annualized rate, 0.30%) vs 296 cases (annualized rate, 0.37%; hazard ratio [HR], 0.78; 95% CI, 0.65-0.93; P = .005) and was associated with statistically significantly lower breast cancer mortality with 30 deaths (annualized mortality rate, 0.031%) vs 46 deaths (annualized mortality rate, 0.046%; HR, 0.60; 95% CI, 0.37-0.97; P = .04).","[{'ForeName': 'Rowan T', 'Initials': 'RT', 'LastName': 'Chlebowski', 'Affiliation': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, California.'}, {'ForeName': 'Garnet L', 'Initials': 'GL', 'LastName': 'Anderson', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Division of Public Health Sciences, Seattle, Washington.'}, {'ForeName': 'Aaron K', 'Initials': 'AK', 'LastName': 'Aragaki', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Division of Public Health Sciences, Seattle, Washington.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Public Health Sciences, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Marcia L', 'Initials': 'ML', 'LastName': 'Stefanick', 'Affiliation': 'Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Pan', 'Affiliation': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, California.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Barrington', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Lewis H', 'Initials': 'LH', 'LastName': 'Kuller', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Simon', 'Affiliation': 'Department of Oncology, Karmanos Cancer Institute at Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Lane', 'Affiliation': 'Department of Family, Population and Preventive Medicine, Stony Brook University, Stony Brook, New York.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Rohan', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Margery L S', 'Initials': 'MLS', 'LastName': 'Gass', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Division of Public Health Sciences, Seattle, Washington.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Cauley', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Electra D', 'Initials': 'ED', 'LastName': 'Paskett', 'Affiliation': 'College of Public Health, The Ohio State University, Columbus.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Sattari', 'Affiliation': 'Division of General Internal Medicine, University of Florida Health Internal Medicine, Gainesville.'}, {'ForeName': 'Ross L', 'Initials': 'RL', 'LastName': 'Prentice', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Division of Public Health Sciences, Seattle, Washington.'}]",JAMA,['10.1001/jama.2020.9482']
1633,32721009,Effect of Intravenous Acetaminophen on Postoperative Hypoxemia After Abdominal Surgery: The FACTOR Randomized Clinical Trial.,"Importance


Opioid-induced ventilatory depression and hypoxemia is common, severe, and often unrecognized in postoperative patients. To the extent that nonopioid analgesics reduce opioid consumption, they may decrease postoperative hypoxemia.
Objective


To test the hypothesis that duration of hypoxemia is less in patients given intravenous acetaminophen than those given placebo.
Design, Setting, and Participants


Randomized, placebo-controlled, double-blind trial conducted at 2 US academic hospitals among 570 patients who were undergoing abdominal surgery, enrolled from February 2015 through October 2018 and followed up until February 2019.
Interventions


Participants were randomized to receive either intravenous acetaminophen, 1 g (n = 289), or normal saline placebo (n = 291) starting at the beginning of surgery and repeated every 6 hours until 48 postoperative hours or hospital discharge, whichever occurred first.
Main Outcomes and Measures


The primary outcome was the total duration of hypoxemia (hemoglobin oxygen saturation [Spo2] <90%) per hour, with oxygen saturation measured continuously for 48 postoperative hours. Secondary outcomes were postoperative opioid consumption, pain (0- 10-point scale; 0: no pain; 10: the most pain imaginable), nausea and vomiting, sedation, minimal alveolar concentration of volatile anesthetic, fatigue, active time, and respiratory function.
Results


Among 580 patients randomized (mean age, 49 years; 48% women), 570 (98%) completed the trial. The primary outcome, median duration with Spo2 of less than 90%, was 0.7 (interquartile range [IQR], 0.1-5.1) minutes per hour among patients in the acetaminophen group and 1.1 (IQR, 0.1-6.6) minutes per hour among patients in the placebo group (P = .29), with an estimated median difference of -0.04 (95% CI,-0.18 to 0.11) minutes per hour. None of the 8 secondary end points differed significantly between the acetaminophen and placebo groups. Mean pain scores within initial 48 postoperative hours were 4.2 (SD, 1.8) in the acetaminophen group and 4.4 (SD, 1.8) in the placebo group (difference, -0.28; 95% CI, -0.71 to 0.15); median opioid use in morphine equivalents was 50 mg (IQR, 18-122 mg) and 58 mg (IQR, 24-151 mg) , respectively, with a ratio of geometric means of 0.86 (95% CI, 0.61-1.21).
Conclusions and Relevance


Among patients who underwent abdominal surgery, use of postoperative intravenous acetaminophen, compared with placebo, did not significantly reduce the duration of postoperative hypoxemia over 48 hours. The study findings do not support the use of intravenous acetaminophen for this purpose.
Trial Registration


ClinicalTrials.gov Identifier: NCT02156154.",2020,"Mean pain scores within initial 48 postoperative hours were 4.2 (SD, 1.8) in the acetaminophen group and 4.4 (SD, 1.8) in the placebo group (difference, -0.28; 95% CI, -0.71 to 0.15); median opioid use in morphine equivalents was 50 mg (IQR, 18-122 mg) and 58 mg (IQR, 24-151 mg) , respectively, with a ratio of geometric means of 0.86 (95% CI, 0.61-1.21).
","['580 patients randomized (mean age, 49 years; 48% women), 570 (98%) completed the trial', 'After Abdominal Surgery', 'patients who underwent abdominal surgery', '570 patients who were undergoing abdominal surgery, enrolled from February 2015 through October 2018 and followed up until February 2019']","['normal saline placebo', 'Intravenous Acetaminophen', 'intravenous acetaminophen', 'acetaminophen', 'placebo']","['postoperative opioid consumption, pain (0- 10-point scale; 0: no pain; 10: the most pain imaginable), nausea and vomiting, sedation, minimal alveolar concentration of volatile anesthetic, fatigue, active time, and respiratory function', 'duration of postoperative hypoxemia', 'median opioid use in morphine equivalents', 'Postoperative Hypoxemia', 'total duration of hypoxemia (hemoglobin oxygen saturation [Spo2] <90%) per hour, with oxygen saturation', 'Mean pain scores', 'median duration with Spo2 of less']","[{'cui': 'C4517818', 'cui_str': '580'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0564385', 'cui_str': '/hour'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",580.0,0.78845,"Mean pain scores within initial 48 postoperative hours were 4.2 (SD, 1.8) in the acetaminophen group and 4.4 (SD, 1.8) in the placebo group (difference, -0.28; 95% CI, -0.71 to 0.15); median opioid use in morphine equivalents was 50 mg (IQR, 18-122 mg) and 58 mg (IQR, 24-151 mg) , respectively, with a ratio of geometric means of 0.86 (95% CI, 0.61-1.21).
","[{'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Essber', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Saasouh', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hovsepyan', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Natalya', 'Initials': 'N', 'LastName': 'Makarova', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Sabry', 'Initials': 'S', 'LastName': 'Ayad', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Barak', 'Initials': 'B', 'LastName': 'Cohen', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Ruetzler', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Loran Mounir', 'Initials': 'LM', 'LastName': 'Soliman', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Maheshwari', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Mascha', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Ali Sakr Esa', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Kessler', 'Affiliation': 'Department of Colorectal Surgery, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Conor P', 'Initials': 'CP', 'LastName': 'Delaney', 'Affiliation': 'Department of Colorectal Surgery, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.10009']
1634,32725393,Effect of a nutritional education intervention on breakfast consumption among preparatory school students in Egypt.,"OBJECTIVES


The current study evaluates the effect of nutritional education based on Pender's health promotion model on breakfast consumption behavior among Egyptian school students.
METHODS


A pre-posttest intervention study through a nutritional education message based on Pender's health promotion model was carried on 244 preparatory school students. Data were collected using questionnaires and measuring weight, height and blood pressure before and after educational intervention was conducted to the intervention group.
RESULTS


The educational intervention was having a significant positive effect on all components of the model in the intervention group, the mean breakfast consumption, frequency of non-skipping and healthy breakfast per week (p ≤ 0.05). Overweight and obesity and higher blood pressure were significantly present among breakfast skippers.
CONCLUSIONS


The nutritional educational intervention based on Pender's health promotion model was effective in increasing the frequency of healthy breakfast among the school students. There is a need to develop evidence-based policies, community, family, and school-based interventions to promote healthy lifestyle and nutritional behavior among adolescents for a better quality of life.",2020,The nutritional educational intervention based on Pender's health promotion model was effective in increasing the frequency of healthy breakfast among the school students.,"['244 preparatory school students', 'preparatory school students in Egypt', 'Egyptian school students']","[""nutritional education based on Pender's health promotion model"", ""nutritional education message based on Pender's health promotion model"", ""nutritional educational intervention based on Pender's health promotion model"", 'nutritional education intervention']","['weight, height and blood pressure', 'mean breakfast consumption, frequency of non-skipping and healthy breakfast', 'Overweight and obesity and higher blood pressure', 'breakfast consumption']","[{'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0557794', 'cui_str': 'Preparatory school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C0013717', 'cui_str': 'Egyptian language'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0204934', 'cui_str': 'Nutrition education'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0560435', 'cui_str': 'Does skip'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",244.0,0.01186,The nutritional educational intervention based on Pender's health promotion model was effective in increasing the frequency of healthy breakfast among the school students.,"[{'ForeName': 'Omnia S', 'Initials': 'OS', 'LastName': 'Elseifi', 'Affiliation': 'Community, Environmental and Occupational Medicine Department, Faculty of Medicine, Zagazig University, Zagazig City, 44519, Egypt. omnia2200@yahoo.com.'}, {'ForeName': 'Doaa M', 'Initials': 'DM', 'LastName': 'Abdelrahman', 'Affiliation': 'Department of Pediatrics, Zagazig University, Zagazig City, 44519, Egypt.'}, {'ForeName': 'Eman M', 'Initials': 'EM', 'LastName': 'Mortada', 'Affiliation': 'Community, Environmental and Occupational Medicine Department, Faculty of Medicine, Zagazig University, Zagazig City, 44519, Egypt.'}]",International journal of public health,['10.1007/s00038-020-01439-7']
1635,32723201,Increase in cortisol concentration due to standardized bright and blue light exposure on saliva cortisol in the morning following sleep laboratory.,"Research studies on LED light exposure and cortisol are inconsistent and not comparable due to different types of light, exposure times, and sample sizes. Therefore, one hour of standardized exposure LED light at different intensities and the spectral composition during the post-awakening phase at 7:30 were compared. A sample of 23 (Study 1) and 26 (Study 2) healthy males were randomly assigned to: 1) bright white light (414 lux) and 2) dim darkened light (<2 lux) as well as 3) red light (235 lux) and 4) blue light (201 lux) exposure conditions. Results from repeated measures ANOVA confirm that light exposure affects the cortisol concentration. Study 1 revealed an increase in the saliva cortisol concentration after bright light exposure compared to dim light. An increase in the cortisol concentration of blue light compared to red light (Study 2) and dim light was found. This study shows that bright light and blue light affect the cortisol response in contrast to dim light and red light conditions. The HPA axis showed a stimulatory effect by bright versus dim light and different wavelengths of light exposure. Lay summary The effects of LED light exposure on the stress hormone cortisol were investigated. The light exposure took place during the hours people would start working at the office. The results showed that after one hour of exposure to bright light or blue light the stress hormones increase in contrast to dim light and red light conditions. Thus, stress hormones can be altered by the types of light people are exposed to.",2020,Results from repeated measures ANOVA confirm that light exposure affects the cortisol concentration.,"['healthy males', 'A sample of 23 (Study 1) and 26 (Study 2']","['bright white light (414\u2009lux) and 2) dim darkened light (<2\u2009lux) as well as 3) red light (235\u2009lux) and 4) blue light (201\u2009lux) exposure conditions', 'LED light exposure']","['stress hormone cortisol', 'saliva cortisol', 'cortisol response', 'saliva cortisol concentration', 'cortisol concentration', 'cortisol concentration of blue light']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C4517771', 'cui_str': '414'}, {'cui': 'C0024176', 'cui_str': 'Luxembourg'}, {'cui': 'C0114346', 'cui_str': 'dimesna'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0297096', 'cui_str': 'arsenotriglutathione'}, {'cui': 'C0563227', 'cui_str': 'Red light'}, {'cui': 'C0303896', 'cui_str': 'Blue light'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0303896', 'cui_str': 'Blue light'}]",,0.0154196,Results from repeated measures ANOVA confirm that light exposure affects the cortisol concentration.,"[{'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Petrowski', 'Affiliation': 'Medical Psychology & Medical Sociology, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Bührer', 'Affiliation': 'Medical Psychology & Medical Sociology, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Albus', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Bjarne', 'Initials': 'B', 'LastName': 'Schmalbach', 'Affiliation': 'Department of Medical Psychology and Medical Sociology, University Medical Center of the Johannes Gutenberg, University Mainz, Mainz, Germany.'}]","Stress (Amsterdam, Netherlands)",['10.1080/10253890.2020.1803265']
1636,32723736,Reducing paediatric overweight and obesity through motivational interviewing: study protocol for a randomised controlled trial in the AAP PROS research network.,"INTRODUCTION


Primary care remains an underused venue for prevention and management of paediatric overweight and obesity. A prior trial demonstrated a significant impact of paediatrician/nurse practitioner (Ped/NP)-and registered dietitian (RD)-delivered motivational interviewing (MI) on child body mass index (BMI). The study described here will test the effectiveness of an enhanced version of this primary care-based MI counselling intervention on child BMI.
METHODS AND ANALYSIS


This cluster randomised effectiveness trial includes 24 Ped/NPs from 18 paediatric primary care practices that belong to the American Academy of Pediatrics (AAP) national Pediatric Research in Office Settings (PROS) practice-based research network. To date, practices have been randomised (nine to intervention and nine to usual care). Intervention Ped/NPs have been trained in MI, behavioural therapy, billing/coding for weight management and study procedures. Usual care Ped/NPs received training in billing/coding and study procedures only. Children 3- 11 years old with BMI  > the 85th percentile were identified via electronic health records (EHRs). Parents from intervention practices have been recruited and enrolled. Over about 2 years, these parents are offered approximately 10 MI-based counselling sessions (about four in person sessions with their child's Ped/NP and up to six telephonic sessions with a trained RD). The primary outcome is change in child BMI (defined as per cent from median BMI for age and sex) over the study period. The primary comparison is between eligible children in intervention practices whose parents enrol in the study and all eligible children in usual care practices. Data sources will include EHRs, billing records, surveys and counselling call notes.
ETHICS AND DISSEMINATION


Institutional Review Board approval was obtained from the AAP. All Ped/NPs provided written informed consent, and intervention group parents provided consent and Health Insurance Portability and Accountability Act (HIPAA) authorisation. Findings will be disseminated through peer-reviewed publications, conference presentations and appropriate AAP channels.
TRIAL REGISTRATION NUMBER


NCT03177148; Pre-results.",2020,"The study described here will test the effectiveness of an enhanced version of this primary care-based MI counselling intervention on child BMI.
","['3- 11 years old with BMI  > the 85th percentile were identified via electronic health records (EHRs', 'eligible children in intervention practices whose parents enrol in the study and all eligible children in usual care practices', 'Children', '24 Ped/NPs from 18 paediatric primary care practices that belong to the American Academy of Pediatrics (AAP) national Pediatric Research in Office Settings']","['paediatrician/nurse practitioner (Ped/NP)-and registered dietitian (RD)-delivered motivational interviewing (MI', 'primary care-based MI counselling intervention']","['child body mass index (BMI', 'change in child BMI']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027341', 'cui_str': 'Nail-patella syndrome'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0442603', 'cui_str': 'Office'}]","[{'cui': 'C0237433', 'cui_str': 'Pediatrician'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.0786239,"The study described here will test the effectiveness of an enhanced version of this primary care-based MI counselling intervention on child BMI.
","[{'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Wright', 'Affiliation': 'Primary Care Research, American Academy of Pediatrics, Itasca, Illinois, USA mewright@uic.edu.'}, {'ForeName': 'Emerson', 'Initials': 'E', 'LastName': 'Delacroix', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Kendrin R', 'Initials': 'KR', 'LastName': 'Sonneville', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Considine', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Proctor', 'Affiliation': ""Physician's Computer Company, Winooski, Vermont, USA.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Steffes', 'Affiliation': 'Primary Care Research, American Academy of Pediatrics, Itasca, Illinois, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Harris', 'Affiliation': 'Primary Care Research, American Academy of Pediatrics, Itasca, Illinois, USA.'}, {'ForeName': 'Laura P', 'Initials': 'LP', 'LastName': 'Shone', 'Affiliation': 'Primary Care Research, American Academy of Pediatrics, Itasca, Illinois, USA.'}, {'ForeName': 'Heide', 'Initials': 'H', 'LastName': 'Woo', 'Affiliation': 'Department of Paediatrics, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Vaughan', 'Affiliation': 'Department of Hospital Biostatistics, The Rockefeller University, New york City, New york, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Grundmeier', 'Affiliation': ""Department of Paediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Fiks', 'Affiliation': 'Pediatric Research in Office Settings, American Academy of Pediatrics, Itasca, Illinois, USA.'}, {'ForeName': 'Melissa S', 'Initials': 'MS', 'LastName': 'Stockwell', 'Affiliation': 'Pediatric Research in Office Settings, American Academy of Pediatrics, Itasca, Illinois, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.'}]",BMJ open,['10.1136/bmjopen-2019-035720']
1637,32723752,Correction: Effects of home-based cardiac exercise rehabilitation with remote electrocardiogram monitoring in patients with chronic heart failure: a study protocol for a randomised controlled trial.,,2020,,['patients with chronic heart failure'],['home-based cardiac exercise rehabilitation with remote electrocardiogram monitoring'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]",[],,0.0542666,,[],BMJ open,['10.1136/bmjopen-2018-023923corr1']
1638,32723753,Correction: Randomised controlled trial of gradual antipsychotic reduction and discontinuation in people with schizophrenia and related disorders: the RADAR trial (Research into Antipsychotic Discontinuation and Reduction).,,2020,,['people with schizophrenia and related disorders'],"['gradual antipsychotic reduction and discontinuation', 'Correction']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",[],,0.0733776,,[],BMJ open,['10.1136/bmjopen-2019-030912corr1']
1639,32726666,Intermittent theta burst stimulation over the dorsomedial prefrontal cortex modulates resting-state connectivity in depressive patients: A sham-controlled study.,"The mechanisms underlying repetitive transcranial magnetic stimulation (rTMS) treatment are largely unknown. Although there is a general lack of sham controlled studies, findings show altered functional connectivity to the stimulated region following treatment. When targeting the dorsolateral prefrontal cortex (dlPFC), connectivity with the subgenual anterior cingulate cortex (sgACC) is predictive of response, but less is known about the effects on functional connectivity of targeting the dorsomedial PFC (dmPFC). Here, 30 patients with an ongoing depressive episode were recruited and randomized to 20 sessions at target intensity of either active or sham intermittent theta burst stimulation (iTBS) over dmPFC. Those receiving sham were offered active treatment in a subsequent open phase. A seven minute resting-state scan and depressive symptom assessment was performed before and after treatment. After exclusions due to attrition and excessive head movements 23 patients remained for analysis. Seed-based resting-state connectivity was calculated using two seeds for the dmPFC target as well as the sgACC. A symptom related increase in dmPFC connectivity after active treatment, compared to sham treatment, was found. The effect was observed in a region overlapping the precuneus and the posterior cingulate cortex (PCC), suggesting an increase in the connectivity between the targeted salience network and the default mode network mediating improvement in depressive symptoms. Connectivity between the precuneus and both the sgACC and the treatment target was predictive of symptom improvement following active treatment. The findings have implications for understanding the mechanisms behind iTBS and may inform future efforts to individualize the treatment.",2020,Connectivity between the precuneus and both the sgACC and the treatment target was predictive of symptom improvement following active treatment.,"['30 patients with an ongoing depressive episode', 'depressive patients']","['repetitive transcranial magnetic stimulation (rTMS', 'Intermittent theta burst stimulation', 'active or sham intermittent theta burst stimulation (iTBS) over dmPFC']",['dmPFC connectivity'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}]","[{'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}]",30.0,0.0349908,Connectivity between the precuneus and both the sgACC and the treatment target was predictive of symptom improvement following active treatment.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Persson', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University, Uppsala, Sweden. Electronic address: jonas.persson@neuro.uu.se.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Struckmann', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gingnell', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University, Uppsala, Sweden; Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Fällmar', 'Affiliation': 'Department of Surgical Sciences, Radiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bodén', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University, Uppsala, Sweden.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112834']
1640,32735335,Effect of a Videoconference-Based Online Group Intervention for Traumatic Stress in Parents of Children With Life-threatening Illness: A Randomized Clinical Trial.,"Importance


A substantial proportion of parents whose child is diagnosed with a life-threatening illness experience high levels of distress that can lead to long-term mental health difficulties. This can affect the child's recovery.
Objective


To evaluate the efficacy of an acceptance and commitment therapy-based group intervention, delivered using videoconferencing, in reducing posttraumatic stress symptoms (PTSS) in these parents.
Design, Setting, and Participants


This study was a randomized clinical trial of an intervention for parents with elevated acute stress symptoms. It was a single-site study conducted in a tertiary pediatric hospital in Australia. Parents of children aged 0 to 18 years admitted for a life-threatening illness or injury to the oncology, cardiology, or pediatric intensive care departments were eligible. Participants were screened for eligibility within the first month after diagnosis or admission and then were randomized to the intervention group or the waiting list control group 4 to 10 months after diagnosis or admission. Recruitment commenced January 2014, and final postintervention follow-up was completed in February 2018. Data analysis was performed from July to September 2018.
Interventions


Treatment was a psychological acceptance and commitment therapy-based group therapy program called Take a Breath, which consisted of a 6-session parent-mediated psychological intervention delivered via online videoconferences over the course of 8 weeks. Waiting list control participants received treatment as usual and were offered the intervention 3 months after randomization.
Main Outcomes and Measures


The primary outcome was PTSS, as measured by the Posttraumatic Stress Disorder Checklist-Version 5 (total score range, 0-80, with higher scores indicating greater symptom severity). The PTSS was measured both before and immediately after the intervention. Changes in psychological skills taught within the intervention were also evaluated, including acceptance, mindfulness, values-based living, and psychological flexibility.
Results


Of 1232 parents who were assessed for eligibility, 313 were randomized; 161 were allocated to the waiting list control group, and 152 were allocated to the intervention group. Of those allocated, 44 parents in the waiting list group and 37 in the intervention group completed the postintervention questionnaire and were analyzed (81 participants total; mean [SD] age, 37.17 [6.43] years). Sixty-five participants (80.2%) were women, 48 participants (59.3%) were married, and 40 participants (49.4%) lived in rural or regional areas, or in a different state. In addition, 24 parents (29.6%) were in the cardiology illness group, 32 parents (39.5%) were in the oncology group, and 25 parents (30.9%) were in the pediatric intensive care unit group. The intervention group demonstrated significantly greater improvements in PTSS compared with the waiting list group (Cohen d = 1.10; 95% CI, 0.61-1.59; P = .03). The mean Posttraumatic Stress Disorder Checklist-Version 5 scores decreased from 31.7 (95% CI, 27.0-36.4) to 26.2 (95% CI, 21.8-30.7) in the waiting list control group and from 23.3 (95% CI, 18.6-28.1) to 17.8 (95% CI, 13.8-21.8) in the intervention group.
Conclusions and Relevance


The findings of this study support the use of acceptance and commitment therapy to reduce PTSS in parents of very ill children, regardless of diagnosis. These findings also suggest that a brief, group format using a videoconferencing platform can be used effectively to access hard-to-reach populations, particularly fathers and caregivers living in nonmetropolitan areas.
Trial Registration


Australian New Zealand Clinical Trials Registry Identifier: ACTRN12611000090910.",2020,"The intervention group demonstrated significantly greater improvements in PTSS compared with the waiting list group (Cohen d = 1.10; 95% CI, 0.61-1.59; P = .03).","['parents with elevated acute stress symptoms', '44 parents in the waiting list group and 37 in the intervention group completed the postintervention questionnaire and were analyzed (81 participants total; mean [SD] age, 37.17 [6.43] years', 'Parents of Children', 'Participants were screened for eligibility within the first month after diagnosis or admission', 'Sixty-five participants (80.2%) were women, 48 participants (59.3%) were married, and 40 participants (49.4%) lived in rural or regional areas, or in a different state', 'tertiary pediatric hospital in Australia', 'With Life-threatening Illness', '24 parents (29.6%) were in the cardiology illness group, 32 parents (39.5%) were in the oncology group, and 25 parents (30.9%) were in the pediatric intensive care unit group', '1232 parents who were assessed for eligibility', 'Parents of children aged 0 to 18 years admitted for a life-threatening illness or injury to the oncology, cardiology, or pediatric intensive care departments were eligible']","['waiting list control', 'Videoconference-Based Online Group Intervention', 'acceptance and commitment therapy-based group intervention, delivered using videoconferencing', 'videoconferencing platform', 'psychological acceptance and commitment therapy-based group therapy program called Take a Breath, which consisted of a 6-session parent-mediated psychological intervention delivered via online videoconferences']","['mean Posttraumatic Stress Disorder Checklist-Version 5 scores', 'acceptance, mindfulness, values-based living, and psychological flexibility', 'PTSS, as measured by the Posttraumatic Stress Disorder Checklist-Version 5 (total score range', 'posttraumatic stress symptoms (PTSS', 'PTSS']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0555047', 'cui_str': 'Married'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C1627360', 'cui_str': 'Pediatric intensive care'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",313.0,0.132341,"The intervention group demonstrated significantly greater improvements in PTSS compared with the waiting list group (Cohen d = 1.10; 95% CI, 0.61-1.59; P = .03).","[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Muscara', 'Affiliation': ""Clinical Sciences, Murdoch Children's Research Institute, The Royal Children's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'McCarthy', 'Affiliation': ""Children's Cancer Centre, The Royal Children's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Rayner', 'Affiliation': ""Clinical Sciences, Murdoch Children's Research Institute, The Royal Children's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Jan M', 'Initials': 'JM', 'LastName': 'Nicholson', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Anica', 'Initials': 'A', 'LastName': 'Dimovski', 'Affiliation': ""Clinical Sciences, Murdoch Children's Research Institute, The Royal Children's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'McMillan', 'Affiliation': ""Clinical Sciences, Murdoch Children's Research Institute, The Royal Children's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Stephen J C', 'Initials': 'SJC', 'LastName': 'Hearps', 'Affiliation': ""Clinical Sciences, Murdoch Children's Research Institute, The Royal Children's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Yamada', 'Affiliation': ""Clinical Sciences, Murdoch Children's Research Institute, The Royal Children's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Burke', 'Affiliation': 'Parenting and Family Support Centre, School of Psychology, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Walser', 'Affiliation': 'Department of Psychology, University of California, Berkeley.'}, {'ForeName': 'Vicki A', 'Initials': 'VA', 'LastName': 'Anderson', 'Affiliation': ""Clinical Sciences, Murdoch Children's Research Institute, The Royal Children's Hospital, Parkville, Victoria, Australia.""}]",JAMA network open,['10.1001/jamanetworkopen.2020.8507']
1641,32736460,"[Aortic valve replacement via J-shaped partial upper sternotomy: randomized trial, mid-term results].","OBJECTIVE


To evaluate the effectiveness and safety of aortic valve replacement through upper partial J-shaped sternotomy compared to conventional sternotomy.
MATERIAL AND METHODS


There were 240 procedures of isolated aortic valve replacement for the period 2012-2017. According to inclusion criteria, 112 patients were randomized into 2 groups: group I - median sternotomy, group II - upper partial J-shaped sternotomy. Mean age of patients was 56.1±14.3 and 53.1±14.9 years, respectively ( p =0.284). Females prevailed in both groups (55.4% vs. 57.1%,  p =0.848). Peak pressure gradient on the aortic valve was 106.2±23.9 and 102.8±25.3 mm Hg, respectively ( p =0.484).
RESULTS


In-hospital mortality was 1.8% ( n =1) in group I ( p =0.315). Incidence of postoperative complications (complete atrioventricular blockade, ventricular septal defect) was similar ( p =1.0). Mean time cross clamping in I and II groups was 65.5±12.5 and 64.7±13.1 min ( p =0.729). Mean follow-up period was 31.6 and 33.5 months, respectively. Kaplan-Meier survival rate was 92.6 and 93.0%, respectively (log-rank test=0,767). Freedom from thromboembolic events was 91.7 and 90% (log-rank test=0.213).
CONCLUSION. U


Pper partial J-shaped sternotomy is safe and effective for aortic valve surgery and characterized by similar outcomes compared to conventional sternotomy.",2020,"U


Pper partial J-shaped sternotomy is safe and effective for aortic valve surgery and characterized by similar outcomes compared to conventional sternotomy.",['There were 240 procedures of isolated aortic valve replacement for the period 2012-2017'],"['conventional sternotomy', 'aortic valve replacement through upper partial J-shaped sternotomy', 'group I - median sternotomy, group II - upper partial J-shaped sternotomy', 'Aortic valve replacement via J-shaped partial upper sternotomy', 'U\n\n\nPper partial J-shaped sternotomy']","['Incidence of postoperative complications (complete atrioventricular blockade, ventricular septal defect', 'Kaplan-Meier survival rate', 'Peak pressure gradient on the aortic valve', 'hospital mortality', 'Mean time cross clamping', 'thromboembolic events']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C1282959', 'cui_str': 'Median sternotomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0018818', 'cui_str': 'Ventricular septal defect'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C0003501', 'cui_str': 'Aortic valve structure'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}]",112.0,0.0217576,"U


Pper partial J-shaped sternotomy is safe and effective for aortic valve surgery and characterized by similar outcomes compared to conventional sternotomy.","[{'ForeName': 'Yu A', 'Initials': 'YA', 'LastName': 'Shneider', 'Affiliation': 'Federal Center for High Medical Technologies of the Ministry of Health, Kaliningrad, Russia.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Tsoi', 'Affiliation': 'Federal Center for High Medical Technologies of the Ministry of Health, Kaliningrad, Russia.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Fomenko', 'Affiliation': 'Federal Center for High Medical Technologies of the Ministry of Health, Kaliningrad, Russia.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Pavlov', 'Affiliation': 'Federal Center for High Medical Technologies of the Ministry of Health, Kaliningrad, Russia.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Shilenko', 'Affiliation': 'Federal Center for High Medical Technologies of the Ministry of Health, Kaliningrad, Russia.'}]",Khirurgiia,['10.17116/hirurgia202007125']
1642,32736464,[Early and long-term outcomes of minimally invasive interventions in urgent colon surgery].,"OBJECTIVE


To analyze the results of minimally invasive surgical treatment of patients with urgent colon diseases.
MATERIAL AND METHODS


There were 89 patients with urgent colon diseases. All patients were divided into 2 groups: the main group - 31 patients who underwent laparoscopic surgeries, the control group - 58 patients operated via open access. Both groups were comparable by age and underlying disease. However, significant differences in gender, severity of comorbidities and complications of the underlying disease were observed.
RESULTS


Surgery time, postoperative morbidity (9.7% vs. 6.9%) and postoperative hospital-stay were similar in both groups. Quality of life was significantly better in the main group compared with the control group if colostomy was absent. In case of stoma, there were no between-group differences.
CONCLUSION


Laparoscopic surgery is associated with reduced need for analgesics, similar duration of intervention and postoperative morbidity. Complete restoration of quality of life in these patients is observed in 6 months after surgery. Colostomy results similar quality of life after laparoscopic and open surgery.",2020,"Surgery time, postoperative morbidity (9.7% vs. 6.9%) and postoperative hospital-stay were similar in both groups.","['patients with urgent colon diseases', 'urgent colon surgery', 'There were 89 patients with urgent colon diseases']","['minimally invasive interventions', 'Laparoscopic surgery', 'laparoscopic and open surgery', 'laparoscopic surgeries, the control group - 58 patients operated via open access']","['quality of life', 'Complete restoration of quality of life', 'Quality of life', 'postoperative hospital-stay', 'Surgery time, postoperative morbidity', 'gender, severity of comorbidities and complications of the underlying disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0009373', 'cui_str': 'Disorder of colon'}, {'cui': 'C0192817', 'cui_str': 'Operation on colon'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0444454', 'cui_str': 'Access'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",89.0,0.0477338,"Surgery time, postoperative morbidity (9.7% vs. 6.9%) and postoperative hospital-stay were similar in both groups.","[{'ForeName': 'B M', 'Initials': 'BM', 'LastName': 'Niyozbekov', 'Affiliation': ""Russian People's Friendship University, Moscow, Russia.""}, {'ForeName': 'T Z', 'Initials': 'TZ', 'LastName': 'Rzaev', 'Affiliation': ""Russian People's Friendship University, Moscow, Russia.""}, {'ForeName': 'Z B', 'Initials': 'ZB', 'LastName': 'Khalilov', 'Affiliation': 'Central Hospital of Baku, Baku, Republic of Azerbaijan.'}, {'ForeName': 'F S', 'Initials': 'FS', 'LastName': 'Kurbanov', 'Affiliation': ""Russian People's Friendship University, Moscow, Russia.""}, {'ForeName': 'R Kh', 'Initials': 'RK', 'LastName': 'Azimov', 'Affiliation': 'Central Clinical Hospital of the Russian Academy of Sciences, Moscow, Russia.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Chinikov', 'Affiliation': ""Russian People's Friendship University, Moscow, Russia.""}, {'ForeName': 'I S', 'Initials': 'IS', 'LastName': 'Panteleeva', 'Affiliation': ""Russian People's Friendship University, Moscow, Russia.""}]",Khirurgiia,['10.17116/hirurgia202007154']
1643,32736046,"Evaluation of sedative effects of an intranasal dosage form containing saffron, lettuce seeds and sweet violet in primary chronic insomnia: A randomized, double-dummy, double-blind placebo controlled clinical trial.","ETHNOPHARMACOLOGICAL RELEVANCE


Traditional Persian Medicine (TPM) has been established as a valuable source of medicinal plants for the treatment of insomnia for thousands of years. Accordingly, oil extracts from plants' parts have been widely used to alleviate central nervous system (CNS) ailments including sleep disorders. A number of preparations have been recommended by TPM for the treatment of insomnia. Among them, an intranasal formulation containing oily macerates of Viola odorata L., Crocus sativus L. and Lactuca sativa L. stands out.
AIM OF THE STUDY


In the present double-dummy, double-blind placebo controlled clinical trial, we aim to evaluate the effectiveness of a combination of violet oil, saffron oil, and lettuce seeds oil nasal drop compared with the placebo (sesame oil).
MATERIALS AND METHODS


Fifty patients with primary chronic insomnia were randomly assigned in TPM-treatment or placebo groups, received either two drops of the herbal oil or placebo into each nostril every noon and evening for 8 weeks. Before the study commencement and after 1, 4 and 8 weeks of treatment, Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) questionnaires were completed by all patients. The primary outcome measure was considered as any changes in ISI scores between the first visit and after 8 weeks. Changes in PSQI scores during the study and possible side effects were also assessed. The multicompound herbal oil was standardized using HPLC analysis and contained 0.02 mg/mL crocin and 4 μg/mL isoquercitrin.
RESULTS


Our study revealed a significant reduction in the ISI and PSQI scores from baseline by the study endpoint (P ≤ 0.01). The mean ISI scores in week 8 decreased significantly for the intervention group (P = 0.001) and also the placebo group (P < 0.01) when compared with baseline. Moreover, the use of hypnotic drugs in the intervention group was significantly reduced (P < 0.001), while in the control group was maintained at baseline level.
CONCLUSIONS


It seems that intranasal use of the multi-herbal preparation can be used to improve chronic insomnia and to reduce the dose of conventional hypnotic medications in insomniac patients.",2020,The mean ISI scores in week 8 decreased significantly for the intervention group (P=0.001) and also the placebo group (P<0.01) when compared with baseline.,"['primary chronic insomnia', 'Fifty patients with primary chronic insomnia']","['violet oil, saffron oil, and lettuce seeds oil nasal drop', 'placebo (sesame oil', 'TPM-treatment or placebo', 'TPM', 'intranasal dosage form containing saffron, lettuce seeds and sweet violet', 'herbal oil or placebo', 'placebo']","['ISI scores', 'mean ISI scores', 'chronic insomnia', 'PSQI scores', 'ISI and PSQI scores', 'Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) questionnaires']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0330463', 'cui_str': 'Viola'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0162753', 'cui_str': 'Saffron Stain'}, {'cui': 'C0242765', 'cui_str': 'Lettuce'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0991524', 'cui_str': 'Nasal drops'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036845', 'cui_str': 'Sesame Oil'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0330464', 'cui_str': 'Viola odorata'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}]","[{'cui': 'C4706228', 'cui_str': 'ISI (Insomnia Severity Index) score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}]",50.0,0.415055,The mean ISI scores in week 8 decreased significantly for the intervention group (P=0.001) and also the placebo group (P<0.01) when compared with baseline.,"[{'ForeName': 'Zhila', 'Initials': 'Z', 'LastName': 'Taherzadeh', 'Affiliation': 'Targeted Drug Delivery Research Center, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hosein', 'Initials': 'H', 'LastName': 'Khaluyan', 'Affiliation': 'Department of Traditional Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Iranshahy', 'Affiliation': 'Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Fariborz', 'Initials': 'F', 'LastName': 'Rezaeitalab', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad Hosein', 'Initials': 'MH', 'LastName': 'Eshaghi Ghalibaf', 'Affiliation': 'Anesthesiology, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Behjat', 'Initials': 'B', 'LastName': 'Javadi', 'Affiliation': 'Department of Traditional Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: javadib@mums.ac.ir.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113116']
1644,32736164,The presence of a caregiver is associated with patient outcomes in patients with Parkinson's disease and atypical parkinsonisms.,"INTRODUCTION


Approximately 88% of men and 79% of women with Parkinson's disease (PD) identify an informal caregiver. Although caregivers can play a key role in supporting patients, little is known about how and whether PD patients with and without caregivers differ in terms of physical, cognitive, and mood outcomes. This study explored whether caregiver presence was associated with variations in patient presentation and outcomes in a palliative PD and atypical PD population.
METHODS


Secondary data on individuals with PD and their caregivers came from baseline data of a 3-site randomized controlled trial of outpatient palliative care for PD in the US and Canada. Measures included: MDS UPDRS III, Montreal Cognitive Assessment, quality of life (QOL) measures, depression, prolonged grief, spirituality (FACIT SP-12) and Palliative Performance Scale.
RESULTS


Of 210 participants, 175 (83%) had a caregiver. Patients with caregivers had greater motor difficulty, lower cognitive scores, and greater palliative needs as measured by the Palliative Performance Scale. Despite poorer cognitive and motor function, those with caregivers had higher QOL as measured by the Quality of Life in Alzheimer Disease and less spiritual distress. There were no group differences on anxiety, depression, or grief. Caregiver presence moderated the association between lower MoCA score and worse motor symptoms.
CONCLUSION


Findings of the present study highlight the influence of caregiver engagement on PD patient outcomes. These findings have implications for clinical practice and suggest that presence of a caregiver may be an important modifying variable on patient outcomes to examine in future research.",2020,"Patients with caregivers had greater motor difficulty, lower cognitive scores, and greater palliative needs as measured by the Palliative Performance Scale.","['Of 210 participants, 175 (83%) had a caregiver', ""patients with Parkinson's disease and atypical parkinsonisms"", 'Secondary data on individuals with PD and their caregivers came from baseline data of a 3-site randomized controlled trial of outpatient palliative care for PD in the US and Canada', ""Approximately 88% of men and 79% of women with Parkinson's disease (PD) identify an informal caregiver""]",[],"['Palliative Performance Scale', 'MDS UPDRS III, Montreal Cognitive Assessment, quality of life (QOL) measures, depression, prolonged grief, spirituality (FACIT SP-12) and Palliative Performance Scale', 'anxiety, depression, or grief', 'lower MoCA score and worse motor symptoms', 'motor difficulty, lower cognitive scores']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0585086', 'cui_str': 'Has a caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C4302185', 'cui_str': 'Atypical Parkinsonism'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}]",[],"[{'cui': 'C4720846', 'cui_str': 'Palliative performance scale'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0237104', 'cui_str': 'Spirituality'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",210.0,0.115968,"Patients with caregivers had greater motor difficulty, lower cognitive scores, and greater palliative needs as measured by the Palliative Performance Scale.","[{'ForeName': 'Lindsay Penny', 'Initials': 'LP', 'LastName': 'Prizer', 'Affiliation': 'Division of General Medicine and Geriatrics, Emory University School of Medicine, 6 Executive Park, 1st Floor, Atlanta, GA, 30329, USA. Electronic address: lprizer@emory.edu.'}, {'ForeName': 'Benzi M', 'Initials': 'BM', 'LastName': 'Kluger', 'Affiliation': 'Departments of Neurology and Medicine, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Sillau', 'Affiliation': 'Department of Neurology, University of Colorado School of Medicine, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Katz', 'Affiliation': 'Weill Institute for Neurosciences, School of Medicine, University of California San Francisco, USA.'}, {'ForeName': 'Nicholas B', 'Initials': 'NB', 'LastName': 'Galifianakis', 'Affiliation': 'Weill Institute for Neurosciences, School of Medicine, University of California San Francisco, USA.'}, {'ForeName': 'Janis M', 'Initials': 'JM', 'LastName': 'Miyasaki', 'Affiliation': 'Parkinson and Movement Disorders Program, Neuropalliative Care, Department of Medicine, University of Alberta, Canada.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.07.003']
1645,32738599,Tumor infiltrating lymphocytes after neoadjuvant IRX-2 immunotherapy in oral squamous cell carcinoma: Interim findings from the INSPIRE trial.,"OBJECTIVES


IRX-2 is a primary-cell-derived immune-restorative consisting of multiple human cytokines that act to overcome tumor-mediated immunosuppression and provide an in vivo tumor vaccination to increase tumor infiltrating lymphocytes (TILs). A randomized phase II trial was conducted of the IRX regimen 3 weeks prior to surgery consisting of an initial dose of cyclophosphamide followed by 10 days of regional perilymphatic IRX-2 cytokine injections and daily oral indomethacin, zinc and omeprazole (Regimen 1) compared to the identical regimen without IRX-2 cytokines (Regimen 2).
METHODS


A total of 96 patients with previously untreated, stage II-IV oral cavity SCC were randomized 2:1 to experimental (1) or control (2) regimens (64:32). Paired biopsy and resection specimens from 62 patients were available for creation of tissue microarray (n = 39), and multiplex immunohistology (n = 54). Increases in CD8+ TIL infiltrate scores of at least 10 cells/mm 2  were used to characterize immune responders (IR).
RESULTS


Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2. In p16 negative cancers (n = 26), significant increases in CD8+ and overall TILs were evident in Regimen 1 (p = 0.004, and 0.04 respectively). IRs were more frequent in Regimen 1 (74% vs 31%, p = 0.01). Multiplex immunohistology for PD-L1 expression confirmed an increase in PD-L1 H score for Regimen 1 compared to Regimen 2 (p = 0.11).
CONCLUSIONS


The findings demonstrate significant increases in TILs after perilymphatic IRX-2 injections. Three quarters of patients showed significant immune responses to IRX-2. (NCT02609386).",2020,"RESULTS


Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2.","['96 patients with previously untreated, stage II-IV oral cavity SCC', 'oral squamous cell carcinoma']","['indomethacin, zinc and omeprazole', 'cyclophosphamide', 'neoadjuvant IRX-2 immunotherapy']","['PD-L1 H score', 'CD8+ TIL infiltrate scores', 'CD8+ infiltrates', 'CD8+ and overall TILs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0585362', 'cui_str': 'Squamous cell carcinoma of mouth'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}]","[{'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0758290', 'cui_str': 'IRX 2'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",96.0,0.0184539,"RESULTS


Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2.","[{'ForeName': 'Gregory T', 'Initials': 'GT', 'LastName': 'Wolf', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States. Electronic address: gregwolf@umich.edu.'}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bellile', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Sartor', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rozek', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Dafydd', 'Initials': 'D', 'LastName': 'Thomas', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Nguyen', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Zarins', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'McHugh', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Oral oncology,['10.1016/j.oraloncology.2020.104928']
1646,32738662,"Reaching reliable change using short, daily, cognitive training exercises delivered on a mobile application: The case of Relationship Obsessive Compulsive Disorder (ROCD) symptoms and cognitions in a subclinical cohort.","BACKGROUND


Relationship Obsessive Compulsive Disorder (ROCD) is a presentation of OCD centering on interpersonal relationships. The aim of this Randomized Control Trial (RCT) was to assess the efficacy of short, game like, daily cognitive interventions delivered via mobile application in reducing subclinical ROCD symptoms and associated phenomena.
METHODS


Fifty university students identified as having subclinical levels of ROCD symptoms (using the Structured Clinical Interview for DSM-5 Clinical Version) were randomized into: immediate-use group (iApp group; n = 25) and delayed-use group (dApp group; n = 25). The iApp group started using the evaluated cognitive-behavioral training application at baseline for 15 days (T0 to T1). The dApp group commenced using the application at T1 for 15 days (T1 to T2). All participants completed questionnaires at baseline (T0), 15 days from baseline (T1), and 30 days from baseline (T2).
RESULTS


Repeated measure MANOVAs showed significant Group (iApp vs. dApp) × Time (T0 vs. T1) interactions. These interactions indicated greater decrease in ROCD symptoms, OCD beliefs and social anxiety symptoms, as well as a greater increase in self-esteem in the iApp group compared to dApp group at T1. Moreover, the Reliable Change Index (RCI) indicated reliable change on ROCD symptoms for a significant portion of participants (42-52%).
LIMITATIONS


Sample size and the use of self-report measures limits the generalizability of the results.
CONCLUSIONS


Short, daily cognitive training interventions delivered via mobile applications may be useful in reducing subclinical ROCD symptoms and associated features. Further testing is needed for clinical populations.",2020,"Moreover, the Reliable Change Index (RCI) indicated reliable change on ROCD symptoms for a significant portion of participants (42-52%).
",['Fifty university students identified as having subclinical levels of ROCD symptoms (using the Structured Clinical Interview for DSM-5 Clinical Version'],"['immediate-use group (iApp group; n\xa0=\xa025) and delayed-use group (dApp group; n\xa0=\xa025', 'cognitive training exercises delivered on a mobile application']","['subclinical ROCD symptoms', 'Relationship Obsessive Compulsive Disorder (ROCD) symptoms and cognitions', 'ROCD symptoms, OCD beliefs and social anxiety symptoms', 'subclinical ROCD symptoms and associated phenomena', 'self-esteem', 'ROCD symptoms']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0199182', 'cui_str': 'History taking'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C2607870', 'cui_str': 'Version'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0063684', 'cui_str': 'Amylin'}, {'cui': 'C0088932', 'cui_str': '1-(diethylaminopropyl)-4-phenylpiperazine'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}]",,0.0611703,"Moreover, the Reliable Change Index (RCI) indicated reliable change on ROCD symptoms for a significant portion of participants (42-52%).
","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Cerea', 'Affiliation': 'Department of General Psychology, University of Padova, Via Venezia, 8, 35131 Padua, Italy. Electronic address: silvia.cerea@unipd.it.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ghisi', 'Affiliation': 'Department of General Psychology, University of Padova, Via Venezia, 8, 35131 Padua, Italy.'}, {'ForeName': 'Gioia', 'Initials': 'G', 'LastName': 'Bottesi', 'Affiliation': 'Department of General Psychology, University of Padova, Via Venezia, 8, 35131 Padua, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Carraro', 'Affiliation': 'Department of General Psychology, University of Padova, Via Venezia, 8, 35131 Padua, Italy.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Broggio', 'Affiliation': 'Department of General Psychology, University of Padova, Via Venezia, 8, 35131 Padua, Italy.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Doron', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center Herzliya, PO Box 167, Herzliya 46150, Israel. Electronic address: gdoron@idc.ac.il.'}]",Journal of affective disorders,['10.1016/j.jad.2020.07.043']
1647,32738817,Effect of electroacupuncture in pre- and postmenopausal women with stress urinary incontinence: A subgroup analysis of two randomised clinical trials.,"OBJECTIVE


To evaluate the effect of electroacupuncture and assess the impact of menopausal status in women with stress urinary incontinence or stress-predominant mixed urinary incontinence.
METHODS


This study was conducted as a subgroup analysis of the data collected from two multicentre, randomised controlled trials conducted on 1004 women; 384 of these subjects were pre- or postmenopausal women who received the same electroacupuncture treatment for stress urinary incontinence or stress-predominant mixed urinary incontinence. The primary outcome evaluated in this study was the proportion of subjects who had at least a 50% reduction in the mean 72-hour incontinence episodes frequency from baseline and the difference between pre- and postmenopausal groups, as measured at the end of 6 weeks using the 72-hour bladder dairy.
RESULTS


Among the 384 women, 132 were premenopausal and 252 were postmenopausal. Compared with the baseline, measurement at the end of 6 weeks of treatment showed at least 50% reduction in the mean 72-hour incontinence episodes frequency in 61.83% and 58.85% of the women in the premenopausal and postmenopausal groups, respectively (difference 1.06%, 95% confidence interval, -13.87 to 15.99; P = .889). No statistically significant intergroup differences were noted in the changes from baseline in the International Consultation on Incontinence Questionnaire-Short Form score and the 1-hour amount of urine leakage. Electroacupuncture-related adverse events occurred in 1.52% of the premenopausal and 1.59% of the postmenopausal women.
CONCLUSION


This subgroup analysis indicated that electroacupuncture can improve the symptoms of urinary incontinence in women with stress urinary incontinence or stress-predominant mixed urinary incontinence and that menopausal status may not affect the effects of electroacupuncture in subjects.",2020,No statistically significant intergroup differences were noted in the changes from baseline in the International Consultation on Incontinence Questionnaire-Short Form score and the 1-h amount of urine leakage.,"['women with stress urinary incontinence or stress predominant mixed urinary incontinence', '1004 women; 384 of these subjects were pre- or postmenopausal women who received the same', 'women with stress urinary incontinence or stress-predominant mixed urinary incontinence', 'Pre- and Postmenopausal Women with Stress Urinary Incontinence', '384 women, 132 were premenopausal and 252 were postmenopausal']","['electroacupuncture treatment', 'electroacupuncture', 'Electroacupuncture']","['symptoms of urinary incontinence', 'stress urinary incontinence or stress-predominant mixed urinary incontinence', 'International Consultation on Incontinence Questionnaire-Short Form score and the 1-h amount of urine leakage', 'mean 72-h incontinence episodes frequency', 'adverse events']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C2711460', 'cui_str': 'International consultation on incontinence questionnaire'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0152245', 'cui_str': 'Extravasation of urine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1004.0,0.15483,No statistically significant intergroup differences were noted in the changes from baseline in the International Consultation on Incontinence Questionnaire-Short Form score and the 1-h amount of urine leakage.,"[{'ForeName': 'Zhiyi', 'Initials': 'Z', 'LastName': 'Xiong', 'Affiliation': ""Department of Acupuncture, China Academy of Chinese Medical Sciences, Guang'anmen Hospital, Beijing, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Tongsheng', 'Initials': 'T', 'LastName': 'Su', 'Affiliation': ""Shanxi Province Hospital of Traditional Chinese Medicine, Xi'an, Shanxi Province, China.""}, {'ForeName': 'Zhishun', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Acupuncture, China Academy of Chinese Medical Sciences, Guang'anmen Hospital, Beijing, China.""}]",International journal of clinical practice,['10.1111/ijcp.13631']
1648,32757272,Vibration improves gait biomechanics linked to posttraumatic knee osteoarthritis following anterior cruciate ligament injury.,"Anterior cruciate ligament reconstruction (ACLR) incurs a high risk of posttraumatic knee osteoarthritis (PTOA). Aberrant gait biomechanics contribute to PTOA and are attributable in part to quadriceps dysfunction. Vibration improves quadriceps function following ACLR, but its effects on gait biomechanics are unknown. The purpose of this study was to evaluate the effects of whole-body vibration (WBV) and local muscle vibration (LMV) on gait biomechanics in individuals with ACLR. Seventy-five volunteers (time since ACLR 27 ± 16 months) were randomized to WBV, LMV, or Control interventions. Walking biomechanics were assessed prior to and following a single exposure to the interventions. Outcomes included pre-post change scores in the ACLR limb for the peak vertical ground reaction force (vGRF) and its loading rate, peak internal knee extension (KEM) and abduction moments, and peak knee flexion and varus angles. LMV produced a significant decrease in the vGRF loading rate (-3.6 BW/s) that was greater than the changes in the WBV (-0.3 BW/s) and Control (0.5 BW/s) groups. Additionally, WBV produced an increase in the peak KEM (0.27% BW × Ht) that was greater than the change in the Control group (-0.17% BW × Ht) but not the LMV group (0.01% BW × Ht). Lower KEM and greater loading rates have been linked to declines in joint health following ACLR. WBV acutely increased the peak KEM and LMV decreased loading rates. These data suggest that vibration has the potential to mitigate aberrant gait biomechanics, and may represent an effective approach for reducing PTOA risk following ACLR.",2020,"Outcomes included pre-post change scores in the ACLR limb for the peak vertical ground reaction force (vGRF) and its loading rate, peak internal knee extension (KEM) and abduction (KAM) moments, and peak knee flexion and varus angles.","['anterior cruciate ligament injury', 'Seventy-five volunteers (time since ACLR 27±16 mo', 'individuals with ACLR']","['Anterior cruciate ligament reconstruction (ACLR', 'whole body vibration (WBV) and local muscle vibration (LMV', 'Vibration', 'LMV', 'WBV, LMV, or Control interventions']","['vGRF loading rate', 'peak KEM', 'Walking biomechanics', 'ACLR limb for the peak vertical ground reaction force (vGRF) and its loading rate, peak internal knee extension (KEM) and abduction (KAM) moments, and peak knee flexion and varus angles', 'quadriceps function', 'peak KEM and LMV decreased loading rates', 'gait biomechanics']","[{'cui': 'C1456574', 'cui_str': 'Injury of anterior cruciate ligament'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]",75.0,0.0187686,"Outcomes included pre-post change scores in the ACLR limb for the peak vertical ground reaction force (vGRF) and its loading rate, peak internal knee extension (KEM) and abduction (KAM) moments, and peak knee flexion and varus angles.","[{'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Blackburn', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Darin A', 'Initials': 'DA', 'LastName': 'Padua', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pietrosimone', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Schwartz', 'Affiliation': 'Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Spang', 'Affiliation': 'Department of Orthopaedics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Goodwin', 'Affiliation': 'Department of Physical Therapy, Elon University, Elon, North Carolina.'}, {'ForeName': 'Derek R', 'Initials': 'DR', 'LastName': 'Dewig', 'Affiliation': 'Department of Allied Health Sciences, Program in Human Movement Science, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Chris D', 'Initials': 'CD', 'LastName': 'Johnston', 'Affiliation': 'Department of Athletic Training, High Point University, North Carolina.'}]",Journal of orthopaedic research : official publication of the Orthopaedic Research Society,['10.1002/jor.24821']
1649,32757317,The effect of vitamin D administration on vitamin D status and respiratory morbidity in late premature infants.,"OBJECTIVE


To assess whether increment of vitamin D daily intake results in improved serum25(OH) vitamin D levels and reduced respiratory morbidity in premature infants.
METHODS


A randomized double-blind clinical pilot trial, including preterm infants born at 32 + 6 to 36 + 6 weeks of gestation. The control group received 400 international units (IU) of cholecalciferol daily compared to 800 IU daily in the intervention group. Levels of 25(OH) vitamin D were measured at birth and 6 and 12 months of age. Respiratory morbidity was followed until 1 year of age.
RESULTS


Fifty subjects were recruited during the study period; the median measured 25(OH) vitamin D levels in the control vs intervention groups were: 26.5 vs 34 nmol/L (P = .271) at birth, 99 vs 75.5 nmol/L (P = .008) at 6 months and 72.5 vs 75 nmol/L (P = .95) at 12 months of age. Infants with insufficient vitamin D (<75 nmol/L) levels had higher respiratory morbidity. Serum vitamin 25(OH) D is a fair predictor for respiratory symptoms (area under the curve [AUC], 0.697; 95% confidence interval [CI], 0.509-0.885; P = .047) and for recorded acute respiratory illnesses (AUC, 0.745; 95% CI, 0.569-0.922; P = .012).
CONCLUSION


Doubling the daily intake of vitamin D in premature infants did not increase serum 25(OH) vitamin D level, due to poor compliance in the intervention group. We found an inverse association between serum 25(OH) vitamin D and respiratory symptoms, indicating vitamin D deficiency is a fair predictor for respiratory morbidity.",2020,"Serum vitamin 25 (OH) D is a fair predictor for respiratory symptoms (AUC 0.697, 95%CI 0.509-0.885, p-value 0.047) and for recorded acute respiratory illnesses (AUC 0.745, 95%CI 0.569-0.922, p-value 0.012).
","['Late Premature Infants', 'premature infants', 'preterm infants born at 32+6 to 36+6 weeks of gestation', 'Fifty subjects']","['vitamin D daily intake', 'Vitamin D', 'vitamin D', '400 IU of cholecalciferol']","['respiratory morbidity', 'serum 25 (OH) vitamin D and respiratory symptoms', 'Serum vitamin 25 (OH) D', 'serum 25 (OH) vitamin D levels', 'Respiratory morbidity', 'Levels of 25 (OH) vitamin D', 'serum 25 (OH) vitamin D level', 'Vitamin D Status and Respiratory Morbidity', 'acute respiratory illnesses', 'median measured 25 (OH) vitamin D levels']","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C1301752', 'cui_str': 'Respiratory morbidity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0428581', 'cui_str': 'Serum vitamin A measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",50.0,0.319027,"Serum vitamin 25 (OH) D is a fair predictor for respiratory symptoms (AUC 0.697, 95%CI 0.509-0.885, p-value 0.047) and for recorded acute respiratory illnesses (AUC 0.745, 95%CI 0.569-0.922, p-value 0.012).
","[{'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Golan-Tripto', 'Affiliation': 'Department of Pediatrics, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bistritzer', 'Affiliation': 'Department of Pediatrics, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Neta', 'Initials': 'N', 'LastName': 'Loewenthal', 'Affiliation': 'Department of Pediatrics, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Orna', 'Initials': 'O', 'LastName': 'Staretz-Chacham', 'Affiliation': 'Department of Neonatology, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Yotam', 'Initials': 'Y', 'LastName': 'Dizitzer', 'Affiliation': 'Clinical Research division, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Aviv', 'Initials': 'A', 'LastName': 'Goldbart', 'Affiliation': 'Department of Pediatrics, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}]",Pediatric pulmonology,['10.1002/ppul.25006']
1650,32755695,Pharmacokinetics of fluoride in human adults: The effect of exercise.,"The literature is sparse in terms of the effect of exercise on the pharmacokinetics of fluoride (F) in humans. In a 4-treatment repeated measures cross-over study, we investigated F pharmacokinetics following no exercise (control) and three exercise intensity conditions (light, moderate and vigorous) in healthy adults. At a pre-experimental session, 8 participants (18-30y) residing in a non-fluoridated-area, underwent a VO 2 max  test to guide the three exercise intensities for the experimental sessions. Participants were on a F-free regime one week before and throughout the four experimental weeks. We measured urinary F excretion (UFE), maximum plasma concentration (Cmax), lag time of Cmax (Tmax), and Area Under the Curve (AUC) for plasma F concentration against time, following F ingestion then no, light, moderate and vigorous exercise. Results showed no statistically significant difference in Tmax among all sessions; whereas Cmax for moderate exercise (226.2 ng/ml) was significantly higher than for no (27.0 ng/ml; p < 0.001), light (105.6 ng/ml; p = 0.016) and vigorous (94.2 ng/ml; p = 0.008) exercise. Mean AUC over 0-90 min following F ingestion was also significantly higher in moderate exercise than for no (p < 0.001), light (p = 0.004) and vigorous (p = 0.001) exercise. Mean UFE over 0-14h was 638.8, 718.7, 574.6 and 450.5  μg for no, light, moderate and vigorous exercise, with no statistically significant differences among different sessions. In conclusion, this human experimental study suggests that moderate exercise may increase the fraction of F absorbed systemically which is therefore available to produce a biological effect. Future studies should be conducted with larger samples, different age groups and using different F doses.",2020,"Mean AUC over 0-90 min following F ingestion was also significantly higher in moderate exercise than for no (p < 0.001), light (p = 0.004) and vigorous (p = 0.001) exercise.","['healthy adults', 'human adults', 'humans']","['no exercise (control) and three exercise intensity conditions (light, moderate and vigorous', 'fluoride']","['Cmax for moderate exercise', 'urinary F excretion (UFE), maximum plasma concentration (Cmax), lag time of Cmax (Tmax), and Area Under the Curve (AUC) for plasma F concentration against time, following F ingestion then no, light, moderate and vigorous exercise', 'Mean AUC', 'Tmax', 'Mean UFE']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0384832,"Mean AUC over 0-90 min following F ingestion was also significantly higher in moderate exercise than for no (p < 0.001), light (p = 0.004) and vigorous (p = 0.001) exercise.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Mahmood', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, UK.'}, {'ForeName': 'Liane B', 'Initials': 'LB', 'LastName': 'Azevedo', 'Affiliation': 'School of Human and Health Sciences, University of Huddersfield, Huddersfield, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Maguire', 'Affiliation': 'School of Dental Sciences, Faculty of Medical Sciences, Newcastle University, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Buzalaf', 'Affiliation': 'Bauru Dental School, University of Sao Paulo, Brazil.'}, {'ForeName': 'Fatemeh Vida', 'Initials': 'FV', 'LastName': 'Zohoori', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, UK. Electronic address: v.zohoori@tees.ac.uk.'}]",Chemosphere,['10.1016/j.chemosphere.2020.127796']
1651,32721578,The home air in agriculture pediatric intervention (HAPI) trial: Rationale and methods.,"BACKGROUND


Data addressing air quality effects on children with asthma in rural U.S. communities are rare. Our community engaged research partnership previously demonstrated associations between neighborhood NH 3  and ambient PM 2.5  and asthma in the agricultural lower Yakima Valley of Washington. As a next step, the partnership desired an intervention approach to address concerns about pediatric asthma in this largely Latino immigrant, farm worker community.
OBJECTIVE


The Home Air in Agriculture Pediatric Intervention (HAPI) sought to examine the effectiveness of enrichment of an existing asthma education program with portable high-efficiency particulate air (HEPA) cleaners designed to reduce PM 2.5  and NH 3.  We investigated the effect of this enriched approach on these exposures and asthma health measures.
DESIGN


We randomized children with poorly controlled asthma to a control arm (current asthma education program) or an intervention arm (current asthma education program + placement of two indoor air cleaners in the family's home). Outcomes included (1) 14-day integrated samples of indoor air contaminants (PM 2.5  and NH 3 ) at baseline and one-year follow-up and (2) child asthma health metrics at baseline, midpoint (4-6 months) and one-year follow-up. These included the Asthma Control Test, symptoms days, clinical utilization, oral corticosteroid use, pulmonary function, fractional exhaled nitric oxide, and urinary leukotriene E 4  concentration.
DISCUSSION


To our knowledge, this is the first randomized HEPA cleaner intervention designed to assess NH 3  as well as PM 2.5  and to evaluate health outcomes of children with asthma in an agricultural region.",2020,"OBJECTIVE


The Home Air in Agriculture Pediatric Intervention (HAPI) sought to examine the effectiveness of enrichment of an existing asthma education program with portable high-efficiency particulate air (HEPA) cleaners designed to reduce PM 2.5  and NH 3.  ","['children with asthma in rural U.S. communities', 'children with asthma in an agricultural region', 'children with poorly controlled asthma to a control arm (current asthma education program) or an']","[""intervention arm (current asthma education program + placement of two indoor air cleaners in the family's home""]","['14-day integrated samples of indoor air contaminants (PM 2.5  and NH 3 ) at baseline and one-year follow-up and (2) child asthma health metrics', 'Asthma Control Test, symptoms days, clinical utilization, oral corticosteroid use, pulmonary function, fractional exhaled nitric oxide, and urinary leukotriene E 4  concentration']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1679754', 'cui_str': 'Asthma education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1679754', 'cui_str': 'Asthma education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0789995', 'cui_str': 'Air cleaner'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0337099', 'cui_str': 'Air contaminant'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C4704932', 'cui_str': 'Health Metrics'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0125644', 'cui_str': 'LTE4'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0221442,"OBJECTIVE


The Home Air in Agriculture Pediatric Intervention (HAPI) sought to examine the effectiveness of enrichment of an existing asthma education program with portable high-efficiency particulate air (HEPA) cleaners designed to reduce PM 2.5  and NH 3.  ","[{'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Masterson', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America. Electronic address: emaster@uw.edu.'}, {'ForeName': 'Lisa B', 'Initials': 'LB', 'LastName': 'Younglove', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Perez', 'Affiliation': ""Yakima Valley Farm Worker's Clinic, Toppenish, WA, United States of America.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Torres', 'Affiliation': 'Northwest Communities Education Center, Radio KDNA, Granger, WA, United States of America.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Krenz', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Maria I', 'Initials': 'MI', 'LastName': 'Tchong French', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Riederer', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Sampson', 'Affiliation': 'Department of Statistics, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Nervana', 'Initials': 'N', 'LastName': 'Metwali', 'Affiliation': 'Department of Occupational and Environmental Health, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Min', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Jansen', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Gino', 'Initials': 'G', 'LastName': 'Aisenberg', 'Affiliation': 'School of Social Work, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Babadi', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Farquhar', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America; Department of Health Services, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Thorne', 'Affiliation': 'Department of Occupational and Environmental Health, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Karr', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America; Department of Pediatrics, University of Washington, Seattle, WA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106085']
1652,32721655,Do ethics classes influence student behavior? Case study: Teaching the ethics of eating meat.,"Do university ethics classes influence students' real-world moral choices? We aimed to conduct the first controlled study of the effects of ordinary philosophical ethics classes on real-world moral choices, using non-self-report, non-laboratory behavior as the dependent measure. We assigned 1332 students in four large philosophy classes to either an experimental group on the ethics of eating meat or a control group on the ethics of charitable giving. Students in each group read a philosophy article on their assigned topic and optionally viewed a related video, then met with teaching assistants for 50-minute group discussion sections. They expressed their opinions about meat ethics and charitable giving in a follow-up questionnaire (1032 respondents after exclusions). We obtained 13,642 food purchase receipts from campus restaurants for 495 of the students, before and after the intervention. Purchase of meat products declined in the experimental group (52% of purchases of at least $4.99 contained meat before the intervention, compared to 45% after) but remained the same in the control group (52% both before and after). Ethical opinion also differed, with 43% of students in the experimental group agreeing that eating the meat of factory farmed animals is unethical compared to 29% in the control group. We also attempted to measure food choice using vouchers, but voucher redemption rates were low and no effect was statistically detectable. It remains unclear what aspect of instruction influenced behavior.",2020,"Purchase of meat products declined in the experimental group (52% of purchases of at least $4.99 contained meat before the intervention, compared to 45% after) but remained the same in the control group (52% both before and after).",['1332 students in four large philosophy classes to either an experimental group on the ethics of eating meat or a control group on the ethics of charitable giving'],['ordinary philosophical ethics classes'],['Purchase of meat products'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0031534', 'cui_str': 'Philosophy'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015000', 'cui_str': 'Ethics'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015000', 'cui_str': 'Ethics'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0025018', 'cui_str': 'Meat products'}]",1332.0,0.0290026,"Purchase of meat products declined in the experimental group (52% of purchases of at least $4.99 contained meat before the intervention, compared to 45% after) but remained the same in the control group (52% both before and after).","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Schwitzgebel', 'Affiliation': 'University of California at Riverside, USA. Electronic address: eschwitz@ucr.edu.'}, {'ForeName': 'Bradford', 'Initials': 'B', 'LastName': 'Cokelet', 'Affiliation': 'University of Kansas, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Singer', 'Affiliation': 'Princeton University, USA.'}]",Cognition,['10.1016/j.cognition.2020.104397']
1653,32721815,Effect of intranasal oxytocin administration on self-other distinction: Modulations by psychological distance and gender.,"Preliminary evidence indicates that intranasal oxytocin (OT) administration modulates one's ability to distinguish oneself from others (i.e., self-other distinction). However, previous findings on this topic are contradictory. The current study addressed this issue by (i) using a novel perceptual matching task examining self-other distinction compared to both close and distant others, and (ii) tentatively exploring potential modulations by gender. In a double-blind, placebo-controlled, randomized OT administration study, 100 participants (50 males and 50 females) were randomized to receive intranasal spray of 24 IU OT or placebo (PL). Afterwards, participants completed a geometry perceptual matching task in which different shapes were paired to the self, a friend, or a stranger. Participants were then asked to judge whether each pair of shapes and labels was correctly matched. The results revealed that compared to PL administration, OT facilitated distinction between the self and a friend in males but not in females. These findings provide insights for debates on the role of OT in self-other distinction by revealing modulations by psychological distance and gender, which have implications for the potential clinical applications of OT.",2020,"The results revealed that compared to PL administration, OT facilitated distinction between the self and a friend in males but not in females.",['100 participants (50 males and 50 females'],"['intranasal spray of 24 IU OT or placebo (PL', 'intranasal oxytocin (OT', 'intranasal oxytocin', 'placebo']",[],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],100.0,0.104773,"The results revealed that compared to PL administration, OT facilitated distinction between the self and a friend in males but not in females.","[{'ForeName': 'Chunliang', 'Initials': 'C', 'LastName': 'Feng', 'Affiliation': 'Key Laboratory of Brain, Cognition and Education Sciences, Ministry of Education, China; School of Psychology, Center for Studies of Psychological Application, and Guangdong Key Laboratory of Mental Health and Cognitive Science, South China Normal University, China. Electronic address: chunliang.feng@m.scnu.edu.cn.'}, {'ForeName': 'Xinmei', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Center of Brain Disorder and Cognitive Sciences, College of Psychology and Sociology, Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China.'}, {'ForeName': 'Xiangru', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Institute of Cognition, Brain and Health, Institute of Psychology and Behavior, Henan University, Kaifeng, China.'}, {'ForeName': 'Ruida', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Shangfeng', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'Center of Brain Disorder and Cognitive Sciences, College of Psychology and Sociology, Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China.'}, {'ForeName': 'Yue-Jia', 'Initials': 'YJ', 'LastName': 'Luo', 'Affiliation': 'Center of Brain Disorder and Cognitive Sciences, College of Psychology and Sociology, Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China. Electronic address: luoyj@szu.edu.cn.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104804']
1654,32723754,Motivational Interview to improve vascular health in Adolescents with poorly controlled type 1 Diabetes (MIAD): a randomized controlled trial.,"INTRODUCTION


We studied if motivational interviewing (MI) added to standard educational care (SEC) improves vascular health in adolescents with poorly controlled type 1 diabetes.
RESEARCH DESIGN AND METHODS


47 adolescents with type 1 diabetes of at least 2 years duration and hemoglobin A1c >75 mmol/mol (>9.0%) on two visits were randomized to MI+SEC or SEC. We also compared vascular health parameters of patients with type 1 diabetes at trial baseline with a group of healthy historical controls matched for age and body size.
RESULTS


39 adolescents (20 MI+SEC) completed the vascular health study. At 12 months, parameter changes were not statistically significantly different between MI+SEC and SEC (carotid-femoral pulse wave velocity (cfPWV): mean difference 0.052 m/s (95% CI -0.395 to 0.500, p=0.81); carotid-radial PWV (crPWV): 0.118 m/s (95% to 0.478 to 0.713, p=0.69), carotid intima-media thickness (IMT): 0.002 mm (95% CI -0.37 to 0.40, p=0.93), systolic blood pressure (BP) z-score: 0.495 (95% CI -0.099 to 1.09, p=0.10). At baseline, duration of type 1 diabetes was associated with radial IMT (r=0.430, p=0.007) and cfPWV (r=0.373, p=0.018), and carotid, femoral and brachial IMT were correlated with continuous glucose monitoring (CGM) SD (r=0.440, p=0.017; r=0.377, p=0.048; r=0.387, p=0.038). There was an inverse association between CGM time-in-range (3.9-10.0 mmol/L) and crPWV (r=-0.476, p=0.022) changes. Systolic BP change was associated with body mass index change (r=0.374, p=0.019) and IMT change (r=0.461, p=0.016 for carotid IMT; r=0.498, p=0.010 for femoral IMT). PWVs were higher and common carotid compliance lower among patients with type 1 diabetes at baseline compared with healthy controls, but no other differences were found.
CONCLUSION


There was no effect of MI added to SEC on vascular health parameters. Although disease duration and glycemic control were associated with vascular health at baseline, there were only limited associations between glycemic control and vascular health parameter changes. Vascular health parameter changes were interrelated suggesting clustering of cardiovascular risk.
TRIAL REGISTRATION NUMBER


NCT02637154.",2020,"At 12 months, parameter changes were not statistically significantly different between MI+SEC and SEC (carotid-femoral pulse wave velocity (cfPWV): mean difference 0.052 m/s (95% CI -0.395 to 0.500, p=0.81); carotid-radial PWV (crPWV): 0.118 m/s (95% to 0.478 to 0.713, p=0.69), carotid intima-media thickness (IMT): 0.002 mm (95% CI -0.37 to 0.40, p=0.93), systolic blood pressure (BP) z-score: 0.495 (95% CI -0.099 to 1.09, p=0.10).","['patients with type 1 diabetes at trial baseline with a group of healthy historical controls matched for age and body size', '39 adolescents (20 MI+SEC) completed the vascular health study', '47 adolescents with type 1 diabetes of at least 2 years duration and hemoglobin A1c', 'Adolescents with poorly controlled type 1 Diabetes (MIAD', 'adolescents with poorly controlled type 1 diabetes']","['MI+SEC\u2009or SEC', 'Motivational Interview', 'motivational interviewing (MI) added to standard educational care (SEC']","['vascular health parameters', 'body mass index change', 'cfPWV', 'continuous glucose monitoring (CGM) SD', 'IMT change', 'carotid, femoral and brachial IMT', 'radial IMT', 'PWVs', 'vascular health', 'CGM time-in-range', 'systolic blood pressure', 'carotid intima-media thickness', 'Systolic BP change']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005901', 'cui_str': 'Body Size'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0334121', 'cui_str': 'Inflammatory myofibroblastic tumor'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",47.0,0.269754,"At 12 months, parameter changes were not statistically significantly different between MI+SEC and SEC (carotid-femoral pulse wave velocity (cfPWV): mean difference 0.052 m/s (95% CI -0.395 to 0.500, p=0.81); carotid-radial PWV (crPWV): 0.118 m/s (95% to 0.478 to 0.713, p=0.69), carotid intima-media thickness (IMT): 0.002 mm (95% CI -0.37 to 0.40, p=0.93), systolic blood pressure (BP) z-score: 0.495 (95% CI -0.099 to 1.09, p=0.10).","[{'ForeName': 'Mari-Anne', 'Initials': 'MA', 'LastName': 'Pulkkinen', 'Affiliation': ""Children's Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Anna-Kaisa', 'Initials': 'AK', 'LastName': 'Tuomaala', 'Affiliation': ""Children's Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Hero', 'Affiliation': ""Children's Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gordin', 'Affiliation': 'Folkhälsan Research Center, Folkhälsan Institute of Genetics, Helsinki, Finland.'}, {'ForeName': 'Taisto', 'Initials': 'T', 'LastName': 'Sarkola', 'Affiliation': ""Children's Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland taisto.sarkola@helsinki.fi.""}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2020-001216']
1655,32723804,"Efficacy and Safety of Daprodustat Compared with Darbepoetin Alfa in Japanese Hemodialysis Patients with Anemia: A Randomized, Double-Blind, Phase 3 Trial.","BACKGROUND AND OBJECTIVES


Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis and regulates genes related to iron metabolism. The efficacy (noninferiority) and safety of daprodustat compared with standard therapy (darbepoetin alfa) was evaluated.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


This was a randomized, phase 3, double-blind, active-control study in Japanese patients receiving hemodialysis with anemia of CKD. Participants' treatment was switched from current erythropoiesis-stimulating agents (ESAs) to daprodustat 4 mg once daily or darbepoetin alfa 10-60  μ g once weekly (on the basis of the prestudy ESA dose). Dose was adjusted every 4 weeks for daprodustat or every 2 weeks for darbepoetin alfa, according to a protocol-specified algorithm. The primary end point was mean hemoglobin during weeks 40-52 in the intent-to-treat population.
RESULTS


Of 332 participants screened, 271 participants were randomized (safety evaluation: 271 participants; efficacy evaluation: 267 intent-to-treat population). The mean hemoglobin during weeks 40-52 were maintained within the target range in both groups (10.9 g/dl [95% confidence interval (95% CI), 10.8 to 11.0] for daprodustat, and 10.8 g/dl [95% CI, 10.7 to 11.0] for darbepoetin alfa). Daprodustat was noninferior to darbepoetin alfa, as the lower bound of the confidence interval for the treatment difference (0.1 g/dl; 95% CI, -0.1 to 0.2 g/dl) was greater than the noninferiority criterion of -1.0 g/dl. For most participants, hemoglobin was maintained within the target range (10.0-12.0 g/dl) during weeks 40-52 (88% daprodustat; 90% darbepoetin alfa). Geometric mean hepcidin levels decreased more at week 52 with daprodustat (-37%; 95% CI, -49 to -23) than with darbepoetin alfa (-20%; 95% CI, -36 to -1), and an increase in total iron-binding capacity was observed in the daprodustat group. Frequency of adverse events were generally similar between daprodustat and darbepoetin alfa.
CONCLUSIONS


Oral daprodustat was noninferior to darbepoetin alfa as measured by mean hemoglobin over weeks 40-52 in Japanese patients receiving hemodialysis switched from ESAs.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


201754, Clinicaltrials.gov, NCT02969655.",2020,"Geometric mean hepcidin levels decreased more at week 52 with daprodustat (-37%; 95% CI, -49 to -23) than with darbepoetin alfa (-20%; 95% CI, -36 to -1), and an increase in total iron-binding capacity was observed in the daprodustat group.","['Japanese Hemodialysis Patients with Anemia', 'Japanese patients receiving hemodialysis switched from ESAs', 'Japanese patients receiving hemodialysis with anemia of CKD', '332 participants screened, 271 participants were randomized', '271 participants; efficacy evaluation: 267 intent-to-treat population']","['current erythropoiesis-stimulating agents (ESAs) to daprodustat 4 mg once daily or darbepoetin alfa', 'standard therapy (darbepoetin alfa', 'Daprodustat Compared with Darbepoetin Alfa']","['Efficacy and Safety', 'Geometric mean hepcidin levels', 'mean hemoglobin', 'hemoglobin', 'total iron-binding capacity', 'Frequency of adverse events']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0700379', 'cui_str': 'Total iron binding capacity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",271.0,0.415077,"Geometric mean hepcidin levels decreased more at week 52 with daprodustat (-37%; 95% CI, -49 to -23) than with darbepoetin alfa (-20%; 95% CI, -36 to -1), and an increase in total iron-binding capacity was observed in the daprodustat group.","[{'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Akizawa', 'Affiliation': 'Division of Nephrology, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Nangaku', 'Affiliation': 'Division of Nephrology and Endocrinology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Taeko', 'Initials': 'T', 'LastName': 'Yonekawa', 'Affiliation': 'Medicines Development, Japan Development, GlaxoSmithKline, Tokyo, Japan taeko.yonekawa@gsk.com.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Okuda', 'Affiliation': 'Medicines Development, Japan Development, GlaxoSmithKline, Tokyo, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Kawamatsu', 'Affiliation': 'Clinical Operations, Japan Development, GlaxoSmithKline, Tokyo, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Onoue', 'Affiliation': 'Biomedical Data Sciences, Japan Development, GlaxoSmithKline, Tokyo, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Endo', 'Affiliation': 'Medicines Development, Japan Development, GlaxoSmithKline, Tokyo, Japan.'}, {'ForeName': 'Katsutoshi', 'Initials': 'K', 'LastName': 'Hara', 'Affiliation': 'Clinical Pharmacology, Japan Development, GlaxoSmithKline, Tokyo, Japan.'}, {'ForeName': 'Alexander R', 'Initials': 'AR', 'LastName': 'Cobitz', 'Affiliation': 'Medicine Delivery, GlaxoSmithKline, Collegeville, Pennsylvania.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.16011219']
1656,32729887,Cost-effectiveness of Breast Cancer Screening With Magnetic Resonance Imaging for Women at Familial Risk.,"Importance


For women with a 20% or more familial risk of breast cancer without a known BRCA1/2 (BRCA1, OMIM 113705; and BRCA2, OMIM 114480) or TP53 (OMIM 151623) variant, screening guidelines vary substantially, and cost-effectiveness analyses are scarce.
Objective


To assess the cost-effectiveness of magnetic resonance imaging (MRI) screening strategies for women with a 20% or more familial risk for breast cancer without a known BRCA1/2 or TP53 variant.
Design, Setting, and Participants


In this economic evaluation, conducted from February 1, 2019, to May 25, 2020, microsimulation modeling was used to estimate costs and effectiveness on a lifetime horizon from age 25 years until death of MRI screening among a cohort of 10 million Dutch women with a 20% or more familial risk for breast cancer without a known BRCA1/2 or TP53 variant. A Dutch screening setting was modeled. Most data were obtained from the randomized Familial MRI Screening (FaMRIsc) trial, which included Dutch women aged 30 to 55 years. A health care payer perspective was applied.
Interventions


Several screening protocols with varying ages and intervals including those of the randomized FaMRIsc trial, consisting of the mammography (Mx) protocol (annual mammography and clinical breast examination) and the MRI protocol (annual MRI and clinical breast examination plus biennial mammography).
Main Outcomes and Measures


Costs, life-years, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated and discounted by 3%. A threshold of €22 000 (US $24 795.87) per QALY was applied.
Results


This economic evaluation modeling study estimated that, on a lifetime horizon per 1000 women with the Mx protocol of the FaMRIsc trial, 346 breast cancers would be detected, and 49 women were estimated to die from breast cancer, resulting in 22 885 QALYs and total costs of €7 084 767 (US $7 985 134.61). The MRI protocol resulted in 79 additional QALYs and additional €2 657 266 (US $2 994 964.65). Magnetic resonance imaging performed only every 18 months between the ages of 35 and 60 years followed by the national screening program was considered optimal, with an ICER of €21 380 (US $24 097.08) compared with the previous nondominated strategy in the ranking, when applying the National Institute for Health and Care Excellence threshold. Annual screening alternating MRI and mammography between the ages of 35 and 60 years, followed by the national screening program, gave similar outcomes. Higher thresholds would favor annual MRI screening. The ICER was most sensitive to the unit cost of MRI and the utility value for ductal carcinoma in situ and localized breast cancer.
Conclusions and Relevance


This study suggests that MRI screening every 18 months between the ages of 35 and 60 years for women with a family history of breast cancer is cost-effective within the National Institute for Health and Care Excellence threshold for all densities. Higher thresholds would favor annual MRI screening. These outcomes support a change of current screening guidelines for this specific risk group and support MRI screening.",2020,The MRI protocol resulted in 79 additional QALYs and additional €2 657 266 (US $2 994 964.65).,"['age 25 years until death of MRI screening among a cohort of 10 million Dutch women with a 20% or more familial risk for breast cancer without a known BRCA1/2 or TP53 variant', 'Dutch women aged 30 to 55 years', 'Women at Familial Risk', '1000 women with the Mx protocol of the FaMRIsc trial, 346 breast cancers would be detected, and 49 women were estimated to die from breast cancer, resulting in 22\u202f885 QALYs and total costs of €7\u202f084\u202f767 (US $7\u202f985\u202f134.61', 'women with a 20% or more familial risk for breast cancer without a known BRCA1/2 or TP53 variant', 'MRI screening every 18 months between the ages of 35 and 60 years for women with a family history of breast cancer']","['Magnetic resonance imaging', 'mammography (Mx) protocol (annual mammography and clinical breast examination) and the MRI protocol (annual MRI and clinical breast examination plus biennial mammography', 'Breast Cancer Screening With Magnetic Resonance Imaging', 'magnetic resonance imaging (MRI) screening strategies']","['Measures\n\n\nCosts, life-years, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0079419', 'cui_str': 'Genes, TP53'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1261325', 'cui_str': 'Family history of breast cancer'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0199850', 'cui_str': 'Examination of breast'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0281182', 'cui_str': 'Screening for malignant neoplasm of breast'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",0.0,0.0459929,The MRI protocol resulted in 79 additional QALYs and additional €2 657 266 (US $2 994 964.65).,"[{'ForeName': 'H Amarens', 'Initials': 'HA', 'LastName': 'Geuzinge', 'Affiliation': 'Department of Public Health, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Inge-Marie', 'Initials': 'IM', 'LastName': 'Obdeijn', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Emiel J T', 'Initials': 'EJT', 'LastName': 'Rutgers', 'Affiliation': 'Department of Surgery, the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Saadatmand', 'Affiliation': 'Department of Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Ritse M', 'Initials': 'RM', 'LastName': 'Mann', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboud University Hospital, Nijmegen, the Netherlands.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Oosterwijk', 'Affiliation': 'Department of Surgery, Medical Centre Leeuwarden, Leeuwarden, the Netherlands.'}, {'ForeName': 'Rob A E M', 'Initials': 'RAEM', 'LastName': 'Tollenaar', 'Affiliation': 'Department of Surgery, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Diderick B W', 'Initials': 'DBW', 'LastName': 'de Roy van Zuidewijn', 'Affiliation': 'Department of Surgery, Medical Centre Leeuwarden, Leeuwarden, the Netherlands.'}, {'ForeName': 'Marc B I', 'Initials': 'MBI', 'LastName': 'Lobbes', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Martijne', 'Initials': 'M', 'LastName': ""van 't Riet"", 'Affiliation': 'Department of Surgery, Reinier de Graaf Gasthuis, Delft, the Netherlands.'}, {'ForeName': 'Maartje J', 'Initials': 'MJ', 'LastName': 'Hooning', 'Affiliation': 'Department of Medical Oncology, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Margreet G E M', 'Initials': 'MGEM', 'LastName': 'Ausems', 'Affiliation': 'Department of Genetics, University Medical Centre Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Claudette E', 'Initials': 'CE', 'LastName': 'Loo', 'Affiliation': 'Department of Radiology and Nuclear Medicine, the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Jelle', 'Initials': 'J', 'LastName': 'Wesseling', 'Affiliation': 'Department of Pathology, the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Ernest J T', 'Initials': 'EJT', 'LastName': 'Luiten', 'Affiliation': 'Department of Surgery, Amphia Ziekenhuis, Breda, the Netherlands.'}, {'ForeName': 'Harmien M', 'Initials': 'HM', 'LastName': 'Zonderland', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Cees', 'Initials': 'C', 'LastName': 'Verhoef', 'Affiliation': 'Department of Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Eveline A M', 'Initials': 'EAM', 'LastName': 'Heijnsdijk', 'Affiliation': 'Department of Public Health, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Madeleine M A', 'Initials': 'MMA', 'LastName': 'Tilanus-Linthorst', 'Affiliation': 'Department of Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'de Koning', 'Affiliation': 'Department of Public Health, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA oncology,['10.1001/jamaoncol.2020.2922']
1657,32729888,Safety and Efficacy of Different Doses and Regimens of Faricimab vs Ranibizumab in Neovascular Age-Related Macular Degeneration: The AVENUE Phase 2 Randomized Clinical Trial.,"Importance


Faricimab, the first bispecific antibody designed for intraocular use, simultaneously and independently binds and neutralizes angiopoietin 2 (Ang-2) and vascular endothelial growth factor A (VEGF-A).
Objective


To assess the efficacy and safety of different doses and regimens of faricimab vs ranibizumab in patients with neovascular age-related macular degeneration (nAMD).
Design, Setting, and Participants


AVENUE was a 36-week, multiple-dose-regimen, active comparator-controlled, double-masked, phase 2 randomized clinical study performed at 58 sites in the United States. Eligible participants were anti-VEGF treatment naive with choroidal neovascularization secondary to nAMD and best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 73 (Snellen equivalent, 20/40) to 24 (Snellen equivalent, 20/320). Data were collected from August 11, 2015, to January 12, 2017, with the final patient visit completed September 26, 2017. Data were analyzed from August 11, 2015, to October 4, 2019.
Interventions


Patients were randomized 3:2:2:2:3 to receive ranibizumab, 0.5 mg every 4 weeks (arm A [n = 68]); faricimab, 1.5 mg every 4 weeks (arm B [n = 47]); faricimab, 6.0 mg every 4 weeks (arm C [n = 42]); faricimab, 6.0 mg every 4 weeks until week 12, then faricimab, 6.0 mg every 8 weeks (arm D [n = 47]); and ranibizumab, 0.5 mg every 4 weeks until week 8, then faricimab, 6.0 mg every 4 weeks (arm E [n = 69]).
Main Outcomes and Measures


Mean change in BCVA from baseline to week 36, proportion of participants gaining at least 15 letters, BCVA of 20/40 or better or 20/200 or worse, and ocular coherence tomographic outcomes in anti-VEGF treatment-naive participants (arms A, B, C, D) and from weeks 12 to 36 in those with incomplete response (participants in arms A and E with week 12 BCVA ETDRS letter score of ≤68 [Snellen equivalent, 20/50 or worse]).
Results


A total of 263 participants were included in the analysis (172 [65.4%] female; 258 [98.1%] white; mean [SD] age, 78.3 [8.7] years). At week 36, adjusted mean change in BCVA vs ranibizumab was 1.6 (80% CI, -1.6 to 4.7) letters for arm B (P = .52), -1.6 (80% CI, -4.9 to 1.7) letters for arm C (P = .53), and -1.5 (80% CI, -4.6 to 1.6) letters for arm D (P = .53). For arm E, adjusted mean change from week 12 was -1.7 (80% CI, -3.8 to 0.4) letters (P = .30).
Conclusions and Relevance


AVENUE did not meet its primary end point of superiority of faricimab over ranibizumab in BCVA at week 36. Although not superior to monthly ranibizumab as given in this trial, overall visual and anatomical gains noted with faricimab support pursuing phase 3 trials for a potential alternative to monthly anti-VEGF therapy. Faricimab showed no new or unexpected safety signals.
Trial Registration


ClinicalTrials.gov Identifier: NCT02484690.",2020,"For arm E, adjusted mean change from week 12 was -1.7","['Data were collected from August 11, 2015, to January 12, 2017, with the final patient visit completed September 26, 2017', 'A total of 263 participants were included in the analysis (172 [65.4%] female; 258 [98.1%] white; mean [SD] age, 78.3 [8.7] years', 'Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 73 (Snellen equivalent, 20/40) to 24 (Snellen equivalent, 20/320', 'Neovascular Age-Related Macular Degeneration', 'patients with neovascular age-related macular degeneration (nAMD', 'Eligible participants were anti-VEGF treatment naive with choroidal neovascularization secondary to nAMD and best-corrected visual acuity (BCVA']","['faricimab vs ranibizumab', 'Faricimab vs Ranibizumab', 'BCVA', 'ranibizumab']","['efficacy and safety', 'BCVA of 20/40 or better or 20/200 or worse, and ocular coherence tomographic outcomes', 'Safety and Efficacy']","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0183370', 'cui_str': 'Snellen chart'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0442752', 'cui_str': 'Distance vision 6/12'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0442752', 'cui_str': 'Distance vision 6/12'}, {'cui': 'C0442756', 'cui_str': 'Distance vision 6/60'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",263.0,0.321469,"For arm E, adjusted mean change from week 12 was -1.7","[{'ForeName': 'Jayashree', 'Initials': 'J', 'LastName': 'Sahni', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Pravin U', 'Initials': 'PU', 'LastName': 'Dugel', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix.'}, {'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Patel', 'Affiliation': 'West Texas Retina Consultants, Abilene.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Chittum', 'Affiliation': 'Retina Consultants of Southern Colorado, Colorado Springs.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Berger', 'Affiliation': 'Retina Research Center, Austin, Texas.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Del Valle Rubido', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Shamil', 'Initials': 'S', 'LastName': 'Sadikhov', 'Affiliation': 'Roche Product Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Szczesny', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Schwab', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Everson', 'Initials': 'E', 'LastName': 'Nogoceke', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Weikert', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Fauser', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.2685']
1658,32727302,Lifestyle counselling by persuasive information and communications technology reduces prevalence of metabolic syndrome in a dose-response manner: a randomized clinical trial (PrevMetSyn).,"OBJECTIVES


The aim was to investigate whether lifestyle changes produced by persuasive Information and Communication Technology (ICT) counselling can lower the prevalence of metabolic syndrome (MetS).
METHODS


A total of 532 participants (20-60 years, body mass index 27-35 kg/m 2 ) were randomly assigned to six arms according to counselling type (no, short-term, or intensive) with or without ICT intervention. In this report the prevalence of MetS and its components were compared between no-ICT group and ICT group. Moreover, the frequency of the web information system usage was analysed for the number of logins, responses to weekly messages, and other record variables.
RESULTS


The ICT group had significantly lower proportion of MetS (33.7% vs. 45.3%,  p  = .022) than the no-ICT group at 2-year follow-up. In mixed model, the ICT group had lower prevalence of MetS than no-ICT group (OR 0.50, 95%CI 0.27-0.90) after intervention. The tertile with the highest utilization had 71% lower prevalence of MetS compared with the lowest utilization tertile or the no-ICT group.
CONCLUSIONS


Web-based ICT is able to reduce the prevalence of MetS. In addition, higher utilization of the web information system is associated with a greater decrease in the prevalence of MetS. Key messages Our internet health behaviour change support system based on persuasive design and cognitive behaviour therapy markedly reduces metabolic syndrome in overweight/obese subjects. As a stand-alone tool it may save healthcare personnel resources as it is suitable at a low cost for both obese/overweight patients and the public at large.",2020,"The ICT group had significantly lower proportion of MetS (33.7% vs. 45.3%,  p  = .022) than the no-ICT group at 2-year follow-up.","['overweight/obese subjects', '532 participants (20-60 years, body mass index 27-35\u2009kg/m 2 ']","['counselling type (no, short-term, or intensive) with or without ICT intervention', 'persuasive Information and Communication Technology (ICT) counselling', 'ICT', 'Lifestyle counselling by persuasive information and communications technology']","['prevalence of MetS', 'proportion of MetS', 'metabolic syndrome']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0683867', 'cui_str': 'Information Technology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]",532.0,0.0498603,"The ICT group had significantly lower proportion of MetS (33.7% vs. 45.3%,  p  = .022) than the no-ICT group at 2-year follow-up.","[{'ForeName': 'Young-Gyun', 'Initials': 'YG', 'LastName': 'Seo', 'Affiliation': 'Department of Family Medicine, Hallym University Sacred Heart Hospital, Anyang, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Tuire', 'Initials': 'T', 'LastName': 'Salonurmi', 'Affiliation': 'Biocenter Oulu, Research Unit of Internal Medicine, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Terhi', 'Initials': 'T', 'LastName': 'Jokelainen', 'Affiliation': 'Unit of Medicine, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Pasi', 'Initials': 'P', 'LastName': 'Karppinen', 'Affiliation': 'Oulu Advanced Research on Service and Information Systems, Faculty of Information Technology and Electrical Engineering, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Teeriniemi', 'Affiliation': 'Biocenter Oulu, Research Unit of Internal Medicine, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Junhee', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Department of Statistics, Hallym University, Chuncheon, Gangwon-do, Republic of Korea.'}, {'ForeName': 'Kyung Hee', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': 'Department of Family Medicine, Hallym University Sacred Heart Hospital, Anyang, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Harri', 'Initials': 'H', 'LastName': 'Oinas-Kukkonen', 'Affiliation': 'Oulu Advanced Research on Service and Information Systems, Faculty of Information Technology and Electrical Engineering, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Markku J', 'Initials': 'MJ', 'LastName': 'Savolainen', 'Affiliation': 'Biocenter Oulu, Research Unit of Internal Medicine, University of Oulu, Oulu, Finland.'}]",Annals of medicine,['10.1080/07853890.2020.1783455']
1659,32730561,Association of Nonoperative Management Using Antibiotic Therapy vs Laparoscopic Appendectomy With Treatment Success and Disability Days in Children With Uncomplicated Appendicitis.,"Importance


Nonoperative management with antibiotics alone has the potential to treat uncomplicated pediatric appendicitis with fewer disability days than surgery.
Objective


To determine the success rate of nonoperative management and compare differences in treatment-related disability, satisfaction, health-related quality of life, and complications between nonoperative management and surgery in children with uncomplicated appendicitis.
Design, Setting, and Participants


Multi-institutional nonrandomized controlled intervention study of 1068 children aged 7 through 17 years with uncomplicated appendicitis treated at 10 tertiary children's hospitals across 7 US states between May 2015 and October 2018 with 1-year follow-up through October 2019. Of the 1209 eligible patients approached, 1068 enrolled in the study.
Interventions


Patient and family selection of nonoperative management with antibiotics alone (nonoperative group, n = 370) or urgent (≤12 hours of admission) laparoscopic appendectomy (surgery group, n = 698).
Main Outcomes and Measures


The 2 primary outcomes assessed at 1 year were disability days, defined as the total number of days the child was not able to participate in all of his/her normal activities secondary to appendicitis-related care (expected difference, 5 days), and success rate of nonoperative management, defined as the proportion of patients initially managed nonoperatively who did not undergo appendectomy by 1 year (lowest acceptable success rate, ≥70%). Inverse probability of treatment weighting (IPTW) was used to adjust for differences between treatment groups for all outcome assessments.
Results


Among 1068 patients who were enrolled (median age, 12.4 years; 38% girls), 370 (35%) chose nonoperative management and 698 (65%) chose surgery. A total of 806 (75%) had complete follow-up: 284 (77%) in the nonoperative group; 522 (75%) in the surgery group. Patients in the nonoperative group were more often younger (median age, 12.3 years vs 12.5 years), Black (9.6% vs 4.9%) or other race (14.6% vs 8.7%), had caregivers with a bachelor's degree (29.8% vs 23.5%), and underwent diagnostic ultrasound (79.7% vs 74.5%). After IPTW, the success rate of nonoperative management at 1 year was 67.1% (96% CI, 61.5%-72.31%; P = .86). Nonoperative management was associated with significantly fewer patient disability days at 1 year than did surgery (adjusted mean, 6.6 vs 10.9 days; mean difference, -4.3 days (99% CI, -6.17 to -2.43; P < .001). Of 16 other prespecified secondary end points, 10 showed no significant difference.
Conclusion and Relevance


Among children with uncomplicated appendicitis, an initial nonoperative management strategy with antibiotics alone had a success rate of 67.1% and, compared with urgent surgery, was associated with statistically significantly fewer disability days at 1 year. However, there was substantial loss to follow-up, the comparison with the prespecified threshold for an acceptable success rate of nonoperative management was not statistically significant, and the hypothesized difference in disability days was not met.
Trial Registration


ClinicalTrials.gov Identifier: NCT02271932.",2020,"Patients in the nonoperative group were more often younger (median age, 12.3 years vs 12.5 years), Black (9.6% vs 4.9%) or other race (14.6% vs 8.7%), had caregivers with a bachelor's degree (29.8% vs 23.5%), and underwent diagnostic ultrasound (79.7% vs 74.5%).","['1209 eligible patients approached, 1068 enrolled in the study', ""1068 children aged 7 through 17 years with uncomplicated appendicitis treated at 10 tertiary children's hospitals across 7 US states between May 2015 and October 2018 with 1-year follow-up through October 2019"", 'Children With Uncomplicated Appendicitis', 'children with uncomplicated appendicitis', '1068 patients who were enrolled (median age, 12.4 years; 38% girls), 370 (35%) chose nonoperative management and 698 (65%) chose surgery']","['Antibiotic Therapy vs Laparoscopic Appendectomy', 'antibiotics alone', 'antibiotics alone (nonoperative group, n\u2009=\u2009370) or urgent (≤12 hours of admission) laparoscopic appendectomy (surgery group, n\u2009=\u2009698']","['total number of days the child was not able to participate in all of his/her normal activities secondary to appendicitis-related care', 'disability, satisfaction, health-related quality of life, and complications', 'patient disability days', 'Inverse probability of treatment weighting (IPTW', 'success rate', 'success rate of nonoperative management']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517543', 'cui_str': '12.4'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439850', 'cui_str': 'Inverse'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",1068.0,0.123447,"Patients in the nonoperative group were more often younger (median age, 12.3 years vs 12.5 years), Black (9.6% vs 4.9%) or other race (14.6% vs 8.7%), had caregivers with a bachelor's degree (29.8% vs 23.5%), and underwent diagnostic ultrasound (79.7% vs 74.5%).","[{'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Minneci', 'Affiliation': ""Center for Surgical Outcomes Research, Abigail Wexner Research Institute at Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, Ohio.""}, {'ForeName': 'Erinn M', 'Initials': 'EM', 'LastName': 'Hade', 'Affiliation': 'Departments of Biomedical Informatics and Obstetrics & Gynecology, The Ohio State University College of Medicine, Columbus, Ohio.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Lawrence', 'Affiliation': ""Center for Surgical Outcomes Research, Abigail Wexner Research Institute at Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, Ohio.""}, {'ForeName': 'Yuri V', 'Initials': 'YV', 'LastName': 'Sebastião', 'Affiliation': ""Center for Surgical Outcomes Research, Abigail Wexner Research Institute at Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, Ohio.""}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Saito', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Grace Z', 'Initials': 'GZ', 'LastName': 'Mak', 'Affiliation': 'Section of Pediatric Surgery, Department of Surgery, University of Chicago Medicine and Biologic Sciences, Chicago, Illinois.'}, {'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Fox', 'Affiliation': 'Section of Pediatric Surgery, Department of Surgery, University of Chicago Medicine and Biologic Sciences, Chicago, Illinois.'}, {'ForeName': 'Ronald B', 'Initials': 'RB', 'LastName': 'Hirschl', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, University of Michigan School of Medicine, Ann Arbor.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Gadepalli', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, University of Michigan School of Medicine, Ann Arbor.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Helmrath', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Kohler', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Leys', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Thomas T', 'Initials': 'TT', 'LastName': 'Sato', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Dave R', 'Initials': 'DR', 'LastName': 'Lal', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Landman', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Kabre', 'Affiliation': ""Division of Pediatric Surgery, Ann & Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, Illinois.""}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Fallat', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, University of Louisville School of Medicine, Louisville, Kentucky.'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Cooper', 'Affiliation': ""Center for Surgical Outcomes Research, Abigail Wexner Research Institute at Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, Ohio.""}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Deans', 'Affiliation': ""Center for Surgical Outcomes Research, Abigail Wexner Research Institute at Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, Ohio.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.10888']
1660,32730613,Effect of an Early Palliative Care Telehealth Intervention vs Usual Care on Patients With Heart Failure: The ENABLE CHF-PC Randomized Clinical Trial.,"Importance


National guidelines recommend early palliative care for patients with advanced heart failure, which disproportionately affects rural and minority populations.
Objective


To determine the effect of an early palliative care telehealth intervention over 16 weeks on the quality of life, mood, global health, pain, and resource use of patients with advanced heart failure.
Design, Setting, and Participants


A single-blind, intervention vs usual care randomized clinical trial was conducted from October 1, 2015, to May 31, 2019, among 415 patients 50 years or older with New York Heart Association class III or IV heart failure or American College of Cardiology stage C or D heart failure at a large Southeastern US academic tertiary medical center and a Veterans Affairs medical center serving high proportions of rural dwellers and African American individuals.
Interventions


The ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers) intervention comprises an in-person palliative care consultation and 6 weekly nurse-coach telephonic sessions (20-40 minutes) and monthly follow-up for 48 weeks.
Main Outcomes and Measures


Primary outcomes were quality of life (as measured by the Kansas City Cardiomyopathy Questionnaire [KCCQ]: score range, 0-100; higher scores indicate better perceived health status and clinical summary scores ≥50 are considered ""fairly good"" quality of life; and the Functional Assessment of Chronic Illness Therapy-Palliative-14 [FACIT-Pal-14]: score range, 0-56; higher scores indicate better quality of life) and mood (as measured by the Hospital Anxiety and Depression Scale [HADS]) over 16 weeks. Secondary outcomes were global health (Patient Reported Outcome Measurement System Global Health), pain (Patient Reported Outcome Measurement System Pain Intensity and Interference), and resource use (hospital days and emergency department visits).
Results


Of 415 participants (221 men; baseline mean [SD] age, 63.8 [8.5] years) randomized to ENABLE CHF-PC (n = 208) or usual care (n = 207), 226 (54.5%) were African American, 108 (26.0%) lived in a rural area, and 190 (45.8%) had a high-school education or less, and a mean (SD) baseline KCCQ score of 52.6 (21.0). At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7; d = 0.07 [95% CI, -0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8; d = 0.12 [95% CI, -0.03 to 0.28]). There were no relevant between-group differences in mood (HADS-anxiety, d = -0.02 [95% CI, -0.20 to 0.16]; HADS-depression, d = -0.09 [95% CI, -0.24 to 0.06]).
Conclusions and Relevance


This randomized clinical trial with a majority African American sample and baseline good quality of life did not demonstrate improved quality of life or mood with a 16-week early palliative care telehealth intervention. However, pain intensity and interference (secondary outcomes) demonstrated a clinically important improvement.
Trial Registration


ClinicalTrials.gov Identifier: NCT02505425.",2020,"At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7; d = 0.07 [95% CI, -0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8; d = 0.12 [95% CI, -0.03 to 0.28]).","['patients with advanced heart failure, which disproportionately affects rural and minority populations', '415 patients 50 years or older with New York Heart Association class III or IV heart failure or American College of Cardiology stage C or D heart failure at a large Southeastern US academic tertiary medical center and a Veterans Affairs medical center serving high proportions of rural dwellers and African American individuals', 'Patients and Caregivers', '415 participants (221 men', ' baseline mean [SD] age, 63.8 [8.5] years) randomized to ENABLE CHF-PC (n\u2009=\u2009208) or usual care (n\u2009=\u2009207), 226 (54.5%) were African American, 108 (26.0%) lived in a rural area, and 190 (45.8%) had a high-school education or less, and a mean (SD) baseline KCCQ score of 52.6 (21.0', 'patients with advanced heart failure', 'Patients With Heart Failure']","['early palliative care telehealth intervention', 'Early Palliative Care Telehealth Intervention vs Usual Care', 'person palliative care consultation and 6 weekly nurse-coach telephonic sessions']","['mean (SE) KCCQ score', 'pain intensity and interference', 'quality of life (as measured by the Kansas City Cardiomyopathy Questionnaire [KCCQ]: score range, 0-100; higher scores indicate better perceived health status and clinical summary scores ≥50 are considered ""fairly good"" quality of life; and the Functional Assessment of Chronic Illness Therapy-Palliative-14 [FACIT-Pal-14]: score range, 0-56; higher scores indicate better quality of life) and mood (as measured by the Hospital Anxiety and Depression Scale [HADS', 'global health (Patient Reported Outcome Measurement System Global Health), pain (Patient Reported Outcome Measurement System Pain Intensity and Interference), and resource use (hospital days and emergency department visits', 'quality of life, mood, global health, pain, and resource use', 'mood (HADS-anxiety, d\u2009', 'quality of life or mood', 'mean (SE) FACIT-Pal-14 score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0441785', 'cui_str': 'Stage C'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0557773', 'cui_str': 'Coach'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0030360', 'cui_str': 'Papillon-Lefèvre syndrome'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.155537,"At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7; d = 0.07 [95% CI, -0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8; d = 0.12 [95% CI, -0.03 to 0.28]).","[{'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Bakitas', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'J Nicholas', 'Initials': 'JN', 'LastName': 'Dionne-Odom', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Deborah B', 'Initials': 'DB', 'LastName': 'Ejem', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Wells', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Azuero', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Macy L', 'Initials': 'ML', 'LastName': 'Stockdill', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Konda', 'Initials': 'K', 'LastName': 'Keebler', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Sockwell', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Sheri', 'Initials': 'S', 'LastName': 'Tims', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Engler', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Steinhauser', 'Affiliation': 'Center for Innovation, Veterans Affairs Medical Center, Durham, North Carolina.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kvale', 'Affiliation': 'Department of Medicine, Dell Medical School, University of Texas at Austin, Austin.'}, {'ForeName': 'Raegan W', 'Initials': 'RW', 'LastName': 'Durant', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Rodney O', 'Initials': 'RO', 'LastName': 'Tucker', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, UAB Center for Palliative and Supportive Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Burgio', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, UAB Center for Palliative and Supportive Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Tallaj', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Swetz', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, UAB Center for Palliative and Supportive Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Salpy V', 'Initials': 'SV', 'LastName': 'Pamboukian', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.2861']
1661,32736216,Combined exercise training improves cognitive functions in multiple sclerosis patients with cognitive impairment: A single-blinded randomized controlled trial.,"BACKGROUND


Cognitive impairment is common in patients with multiple sclerosis (MS). The effects of different exercise trainings on cognitive functions in patients with MS are promising. However, the effects are not yet clear in MS patients with cognitive impairment. This study aimed to investigate the effect of combined exercise training on different cognitive functions in MS patients with cognitive impairment.
METHODS


Relapsing-remitting and mild disabled MS patients with cognitive impairment were randomly assigned to two groups: Exercise Group (EG, n:17) and the Control Group (CG, n:17). The EG received a combined exercise training consisting of aerobic and Pilates training in three sessions per week for 8 weeks while the CG performed the relaxation exercises at home. Cognitive functions, walking capacity, fatigue, mood, and quality of life were assessed at baseline and after eight weeks using the Brief Repeatable Battery of Neuropsychological Tests (BRB-N), Six-Minute Walk Test (6-MWT), Fatigue Impact Scale (FIS), Beck's Depression Inventory (BDI) and MS Quality of Life-54 (MSQoL-54), respectively.
RESULTS


This study showed significant group-by-time interactions on long-term verbal memory, walking capacity, cognitive fatigue, and physical quality of life in favor of the EG (p<0.003). Moreover, verbal memory, visuospatial memory, verbal fluency, information processing speed, walking capacity, fatigue, and quality of life improved in the EG (p<0.05) while only verbal memory increased in the CG (p<0.05). Furthermore, the change in visuospatial memory was associated with the change in mental quality of life (r:0.352, p: 0.041) while the change in verbal fluency (r: -0.362, p:0.035) and processing speed (r: -0.356, p:0.039) were associated with the change in mood.
CONCLUSION


Combined exercise training has beneficial effects on different cognitive functions in mild disabled RRMS patients with cognitive impairment. In addition, there is a mutual relationship in improvements in cognitive functions, mood, and quality of life after exercise.",2020,"This study showed significant group-by-time interactions on long-term verbal memory, walking capacity, cognitive fatigue, and physical quality of life in favor of the EG (p<0.003).","['mild disabled RRMS patients with cognitive impairment', 'multiple sclerosis patients with cognitive impairment', 'patients with MS', 'Relapsing-remitting and mild disabled MS patients with cognitive impairment', 'patients with multiple sclerosis (MS', 'MS patients with cognitive impairment']","['Combined exercise training', 'combined exercise training consisting of aerobic and Pilates training', 'exercise trainings', 'Exercise Group (EG, n:17) and the Control Group (CG, n:17', 'combined exercise training']","['change in visuospatial memory', 'verbal fluency', 'long-term verbal memory, walking capacity, cognitive fatigue, and physical quality of life', 'processing speed', 'Cognitive functions, walking capacity, fatigue, mood, and quality of life', 'cognitive functions', ""Brief Repeatable Battery of Neuropsychological Tests (BRB-N), Six-Minute Walk Test (6-MWT), Fatigue Impact Scale (FIS), Beck's Depression Inventory (BDI) and MS Quality of Life-54 (MSQoL-54), respectively"", 'verbal memory, visuospatial memory, verbal fluency, information processing speed, walking capacity, fatigue, and quality of life improved in the EG (p<0.05) while only verbal memory', 'mental quality of life', 'cognitive functions, mood, and quality of life']","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C1522002', 'cui_str': 'RRM Motif'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.0502248,"This study showed significant group-by-time interactions on long-term verbal memory, walking capacity, cognitive fatigue, and physical quality of life in favor of the EG (p<0.003).","[{'ForeName': 'Cagla', 'Initials': 'C', 'LastName': 'Ozkul', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey. Electronic address: caglaozkul@hotmail.com.'}, {'ForeName': 'Arzu', 'Initials': 'A', 'LastName': 'Guclu-Gunduz', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Kader', 'Initials': 'K', 'LastName': 'Eldemir', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Apaydin', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Gokhan', 'Initials': 'G', 'LastName': 'Yazici', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Ceyla', 'Initials': 'C', 'LastName': 'Irkec', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Neurology, Ankara, Turkey.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102419']
1662,32737097,Ensemble programme for early intervention in informal caregivers of psychiatric adult patients: a protocol for a randomised controlled trial.,"INTRODUCTION


Informal caregivers play a major role in the support and maintenance of community patients with severe psychiatric disorders. A pilot study showed that an individualised brief intervention such as the Ensemble programme leads to significant improvements in psychological health state and optimism.
METHODS AND ANALYSIS


This randomised controlled trial aims to compare the efficacy of using Ensemble in improving informal caregivers' psychological health states and the ability to play an active role in their situations with that of support as usual. Improvements on the psychological health global index will be measured three times (T0-pre, T1-post and T3 2 months follow) with standardised questionnaires (the Global Severity Index of Brief Inventory Symptoms, the Life Orientation Test-Revised, the 36-item Medical Outcome Study Short-Form Health Survey and the French Zarit Burden Interview). Differences between groups in post-test and pretest values will be examined using an analysis of covariance for each outcome variable. The severity of illness measured by the Social and Occupational Functioning Assessment Scale will also be collected at T0 and T2 to compare eventual patient improvements. At the end of the programme, the experiences of the 20 patients participating in the Ensemble programme will be evaluated qualitatively.
ETHICS AND DISSEMINATION


The research protocol received full authorisation from the Human Research Ethics Committee of the Vaud state, Switzerland. The principal paper will concern the results of the experimental design used to test the Ensemble programme. The research team will prioritise open access publications.
TRIAL REGISTRATION NUMBER


NCT04020497.",2020,"A pilot study showed that an individualised brief intervention such as the Ensemble programme leads to significant improvements in psychological health state and optimism.
","['informal caregivers of psychiatric adult patients', 'community patients with severe psychiatric disorders', '20 patients participating in the Ensemble programme will be evaluated qualitatively']",[],"['severity of illness measured by the Social and Occupational Functioning Assessment Scale', 'Global Severity Index of Brief Inventory Symptoms, the Life Orientation Test-Revised, the 36-item Medical Outcome Study Short-Form Health Survey and the French Zarit Burden Interview', 'psychological health state and optimism', 'psychological health global index']","[{'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]",[],"[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0582640', 'cui_str': 'Life orientation test'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}]",20.0,0.0922263,"A pilot study showed that an individualised brief intervention such as the Ensemble programme leads to significant improvements in psychological health state and optimism.
","[{'ForeName': 'Shyhrete', 'Initials': 'S', 'LastName': 'Rexhaj', 'Affiliation': 'La Source, School of Nursing, University of Applied Sciences and Arts Western Switzerland, HES-SO, Lausanne, Vaud, Switzerland s.rexhaj@ecolelasource.ch.'}, {'ForeName': 'Shadya', 'Initials': 'S', 'LastName': 'Monteiro', 'Affiliation': 'La Source, School of Nursing, University of Applied Sciences and Arts Western Switzerland, HES-SO, Lausanne, Vaud, Switzerland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Golay', 'Affiliation': 'Community Psychiatry Service, Department of Psychiatry, Lausanne, CHUV, Lausanne, VD, Switzerland.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Coloni-Terrapon', 'Affiliation': 'La Source, School of Nursing, University of Applied Sciences and Arts Western Switzerland, HES-SO, Lausanne, Vaud, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wenger', 'Affiliation': 'La Source, School of Nursing, University of Applied Sciences and Arts Western Switzerland, HES-SO, Lausanne, Vaud, Switzerland.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Favrod', 'Affiliation': 'La Source, School of Nursing, University of Applied Sciences and Arts Western Switzerland, HES-SO, Lausanne, Vaud, Switzerland.'}]",BMJ open,['10.1136/bmjopen-2020-038781']
1663,32737249,Correction: Cost-utility analysis of learning and coping versus standard education in cardiac rehabilitation: a randomised controlled trial with 3 years of follow-up.,,2020,,['cardiac rehabilitation'],['learning and coping versus standard education'],[],"[{'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],,0.11373,,[],Open heart,['10.1136/openhrt-2019-001184corr1']
1664,32735501,Efficacy of pramipexole combined with levodopa for Parkinson's disease treatment and their effects on QOL and serum TNF- α  levels.,"PURPOSE


To investigate the efficacy of combining the dopamine receptor agonist pramipexole with levodopa for Parkinson's disease (PD) treatment and to measure their effects on quality of life and tumor necrosis factor (TNF)-α levels in PD patients.
BASIC PROCEDURE


In total, 160 PD patients who were admitted to our hospital were equally randomized into a control treatment group (levodopa alone) and the study group (pramipexole combined with levodopa). Both groups were treated for 12 weeks.
FINDINGS


After treatment, scores from the Unified Parkinson's Disease Rating Scales (1-3), the Hamilton Depression Scale, and the Parkinson's Disease Questionnaire (PDQ-39) were significantly decreased in both groups, whereas Mini-Mental State Examination scores were significantly increased. After treatment, the study group had significantly lower scores for all scales except the Mini-Mental State Examination, for which those who received combined treatment had significantly higher scores than the control group. The incidence of adverse reactions was significantly lower in the study group than in the control group. Furthermore, after treatment, serum TNF-α levels were significantly decreased in both groups compared with pre-treatment levels.
CONCLUSION


Pramipexole combined with levodopa relieved PD symptoms and improved the quality of life of PD patients, potentially by suppressing serum TNF-α levels.",2020,"After treatment, the study group had significantly lower scores for all scales except the Mini-Mental State Examination, for which those who received combined treatment had significantly higher scores than the control group.","['PD patients', '160 PD patients who were admitted to our hospital', ""Parkinson's disease (PD""]","['dopamine receptor agonist pramipexole with levodopa', 'pramipexole combined with levodopa', 'Pramipexole', 'control treatment group (levodopa alone) and the study group (pramipexole combined with levodopa', 'levodopa']","['quality of life', 'quality of life and tumor necrosis factor (TNF)-α levels', 'Mini-Mental State Examination scores', ""Unified Parkinson's Disease Rating Scales"", ""Hamilton Depression Scale, and the Parkinson's Disease Questionnaire (PDQ-39"", 'QOL and serum TNF- α  levels', 'serum TNF-α levels', 'PD symptoms', 'incidence of adverse reactions']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0074710', 'cui_str': 'Pramipexole'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",160.0,0.0158009,"After treatment, the study group had significantly lower scores for all scales except the Mini-Mental State Examination, for which those who received combined treatment had significantly higher scores than the control group.","[{'ForeName': 'Jinzhong', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Neurology, the Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hong', 'Affiliation': 'Department of Neurology, the Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, China.'}, {'ForeName': 'Zhilong', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, the Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Ding', 'Affiliation': 'Department of Neurology, the Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': 'Department of Neurology, the Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, China.'}]",The Journal of international medical research,['10.1177/0300060520922449']
1665,32738408,Positive Health Check evaluation: A type 1 hybrid design randomized trial to decrease HIV viral loads in patients seen in HIV primary care.,"For people with HIV, important transmission prevention strategies include early initiation and adherence to antiretroviral therapy and retention in clinical care with the goal of reducing viral loads as quickly as possible. Consequently, at this point in the HIV epidemic, innovative and effective strategies are urgently needed to engage and retain people in health care to support medication adherence. To address this gap, the Positive Health Check Evaluation Trial uses a type 1 hybrid randomized trial design to test whether the use of a highly tailored video doctor intervention will reduce HIV viral load and retain people with HIV in health care. Eligible and consenting patients from four HIV primary care clinical sites are randomly assigned to receive either the Positive Health Check intervention in addition to the standard of care or the standard of care only. The primary aim is to determine the effectiveness of the intervention. A second aim is to understand the implementation potential of the intervention in clinic workflows, and a third aim is to assess the costs of intervention implementation. The trial findings will have important real-world applicability for understanding how digital interventions that take the form of video doctors can be used to decrease viral load and to support retention in care among diverse patients attending HIV primary care clinics.",2020,Eligible and consenting patients from four HIV primary care clinical sites are randomly assigned to receive either the Positive Health Check intervention in addition to the standard of care or the standard of care only.,"['diverse patients attending HIV primary care clinics', 'Eligible and consenting patients from four HIV primary care clinical sites', 'people with HIV in health care', 'patients seen in HIV primary care']",['Positive Health Check intervention in addition to the standard of care or the standard of care only'],['HIV viral loads'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C1168369', 'cui_str': 'HIV viral load'}]",4.0,0.0882936,Eligible and consenting patients from four HIV primary care clinical sites are randomly assigned to receive either the Positive Health Check intervention in addition to the standard of care or the standard of care only.,"[{'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America. Electronic address: melewis@rti.org.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Harshbarger', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, United States of America.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Bann', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Burrus', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Peinado', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Bryan R', 'Initials': 'BR', 'LastName': 'Garner', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Khavjou', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Ram K', 'Initials': 'RK', 'LastName': 'Shrestha', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, United States of America.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Karns', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Craig B', 'Initials': 'CB', 'LastName': 'Borkowf', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, United States of America.'}, {'ForeName': 'Brittany A', 'Initials': 'BA', 'LastName': 'Zulkiewicz', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Carla A', 'Initials': 'CA', 'LastName': 'Galindo', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, United States of America.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'DallaPiazza', 'Affiliation': 'Rutgers New Jersey Medical School, Newark, NJ, United States of America.'}, {'ForeName': 'Pam', 'Initials': 'P', 'LastName': 'Holm', 'Affiliation': 'NO AIDS Task Force dba CrescentCare, New Orleans, LA, United States of America.'}, {'ForeName': 'Vincent C', 'Initials': 'VC', 'LastName': 'Marconi', 'Affiliation': 'Division of Infectious Diseases, Emory University School of Medicine, Emory Vaccine Center, and Rollins School of Public Health, Atlanta, GA, United States of America; Atlanta VA Medical Center, Decatur, GA, United States of America.'}, {'ForeName': 'Charurut', 'Initials': 'C', 'LastName': 'Somboonwit', 'Affiliation': 'University of South Florida, Morsani College of Medicine, Tampa, FL, United States of America.'}, {'ForeName': 'Shobha', 'Initials': 'S', 'LastName': 'Swaminathan', 'Affiliation': 'Rutgers New Jersey Medical School, Newark, NJ, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106097']
1666,32758135,Outpatient psychotherapy for home-living vulnerable older adults with depression: study protocol of the PSY-CARE trial.,"BACKGROUND


There is a need to improve psychotherapeutic approaches to treatment for vulnerable older adults with depression in terms of both clinical practice and health care supply. Against this background, PSY-CARE is testing the feasibility and effectiveness of outpatient psychotherapy for home-living older adults in need of care with depression in Berlin, Germany, and neighboring suburban areas.
METHODS


In a two-arm single-center pragmatic randomized controlled trial (RCT), manual-guided outpatient psychotherapy will be compared to brief psychosocial counseling. The study population will be compromised of older adults with clinically significant depressive symptoms who have a long-term care grade, as assessed by the German compulsory state nursing care insurance. In the intervention group, individual cognitive-behavioral psychotherapy tailored to the specific needs of this population will be offered by residential psychotherapists as part of the regular healthcare service. In the active control group, participants will receive individual psychosocial telephone counselling and a self-help guide. The planned sample size is N = 130 (n = 65 participants per group). The reduction of depressive symptoms (primary outcome) as well as the maintaining of activities of daily living, quality of life, and functioning will be assessed with questionnaires provided at baseline, after the end of the intervention and after three months. Feasibility and process evaluation will be conducted qualitatively based on documentation and interviews with psychotherapists, gatekeepers and the participants.
DISCUSSION


PSY-CARE investigates the potentials and limitations of providing outpatient psychotherapeutic treatment meeting the demands of vulnerable home-living older adults with depression under the real conditions of the health care system. The study will provide practical implications to improve access to and quality of outpatient psychotherapy for this poorly supplied population.
TRIAL REGISTRATION


The trial is registered at ISRCTN55646265 ; February 15, 2019.",2020,"The reduction of depressive symptoms (primary outcome) as well as the maintaining of activities of daily living, quality of life, and functioning will be assessed with questionnaires provided at baseline, after the end of the intervention and after three months.","['home-living older adults in need of care with depression in Berlin, Germany, and neighboring suburban areas', 'vulnerable older adults with depression', 'older adults with clinically significant depressive symptoms who have a long-term care grade, as assessed by the German compulsory state nursing care insurance', 'home-living vulnerable older adults with depression']","['individual psychosocial telephone counselling and a self-help guide', 'manual-guided outpatient psychotherapy', 'outpatient psychotherapy', 'Outpatient psychotherapy', 'individual cognitive-behavioral psychotherapy']","['maintaining of activities of daily living, quality of life, and functioning will be assessed with questionnaires', 'reduction of depressive symptoms']","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C1553702', 'cui_str': 'Neighbor'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1283220', 'cui_str': 'Guide help'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.119432,"The reduction of depressive symptoms (primary outcome) as well as the maintaining of activities of daily living, quality of life, and functioning will be assessed with questionnaires provided at baseline, after the end of the intervention and after three months.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gellert', 'Affiliation': 'Institute for Medical Sociology and Rehabilitation Science, Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany. paul.gellert@charite.de.'}, {'ForeName': 'Ann-Kristin', 'Initials': 'AK', 'LastName': 'Beyer', 'Affiliation': 'Institute for Medical Sociology and Rehabilitation Science, Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Tegeler', 'Affiliation': 'MSB Medical School Berlin, Department of Psychology, Rüdesheimer Str. 50, 14197, Berlin, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Vathke', 'Affiliation': 'MSB Medical School Berlin, Department of Psychology, Rüdesheimer Str. 50, 14197, Berlin, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Nordheim', 'Affiliation': 'Institute for Medical Sociology and Rehabilitation Science, Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Adelheid', 'Initials': 'A', 'LastName': 'Kuhlmey', 'Affiliation': 'Institute for Medical Sociology and Rehabilitation Science, Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Eva-Marie', 'Initials': 'EM', 'LastName': 'Kessler', 'Affiliation': 'MSB Medical School Berlin, Department of Psychology, Rüdesheimer Str. 50, 14197, Berlin, Germany.'}]",BMC geriatrics,['10.1186/s12877-020-01661-1']
1667,32758147,Implementation of a complex intervention to improve participation in older people with joint contractures living in nursing homes: a process evaluation of a cluster-randomised pilot trial.,"BACKGROUND


Joint contractures in frail older people are associated with serious restrictions in participation. We developed the Participation Enabling CAre in Nursing (PECAN) intervention, a complex intervention to enable nurses to promote participation in nursing home residents with joint contractures. The aim of this study was to examine the feasibility of the implementation strategy and to identify enablers and barriers for a successful implementation.
METHODS


The implementation of PECAN was investigated in a 6-month pilot cluster-randomised controlled trial (c-RCT). As a key component of the implementation strategy, nominated nurses were trained as facilitators in a one-day workshop and supported by peer-mentoring (visit, telephone counselling). A mixed-methods approach was conducted in conjunction with the pilot trial and guided by a framework for process evaluations of c-RCTs. Data were collected using standardised questionnaires (nursing staff), documentation forms, problem-centred qualitative interviews (facilitators, therapists, social workers, relatives, peer-mentors), and a group discussion (facilitators). A set of predefined criteria on the nursing home level was examined. Quantitative data were analysed using descriptive statistics. Qualitative data were analysed using directed content analysis.
RESULTS


Seven nursing homes (n = 4 intervention groups, n = 3 control groups) in two regions of Germany took part in the study. Facilitators responded well to the qualification measures (workshop participation: 14/14; workshop rating: ""good""; peer-mentor visit participation: 10/14). The usage of peer-mentoring via telephone varied (one to seven contacts per nursing home). Our implementation strategy was not successful in connection with supplying the intervention to all the nurses. The clear commitment of the entire nursing home and the respect for the expertise of different healthcare professionals were emphasised as enablers, whereas a lack of impact on organisational conditions and routines and a lack of time and staff competence were mentioned as barriers.
CONCLUSION


The PECAN intervention was delivered as planned to the facilitators but was unable to produce comprehensive changes in the nursing homes and subsequently for the residents. Strategies to systematically include the management and the nursing team from the beginning are needed to support the facilitators during implementation in the main trial.
TRIAL REGISTRATION


German clinical trials register, DRKS00010037 . Registered 12 February 2016.",2020,The PECAN intervention was delivered as planned to the facilitators but was unable to produce comprehensive changes in the nursing homes and subsequently for the residents.,"['frail older people', 'older people with joint contractures living in nursing homes', 'nursing home residents with joint contractures']","['Participation Enabling CAre in Nursing (PECAN) intervention', 'complex intervention']",[],"[{'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009918', 'cui_str': 'Contracture of joint'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]",[],,0.0477284,The PECAN intervention was delivered as planned to the facilitators but was unable to produce comprehensive changes in the nursing homes and subsequently for the residents.,"[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Klingshirn', 'Affiliation': 'Institute for Medical Information Processing, Biometry and Epidemiology, Ludwig-Maximilians-Universität München, Marchioninistr 17, 81377, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Müller', 'Affiliation': 'Faculty of Applied Health and Social Sciences, Rosenheim Technical University of Applied Sciences, Hochschulstraße 1, 83024, Rosenheim, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Beutner', 'Affiliation': 'Institute for Health and Nursing Sciences, Medical Faculty, Martin Luther University Halle-Wittenberg, Magdeburger Straße 8, 06112, Halle (Saale), Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Hirt', 'Affiliation': 'Institute for Health and Nursing Sciences, Medical Faculty, Martin Luther University Halle-Wittenberg, Magdeburger Straße 8, 06112, Halle (Saale), Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Strobl', 'Affiliation': 'Institute for Medical Information Processing, Biometry and Epidemiology, Ludwig-Maximilians-Universität München, Marchioninistr 17, 81377, Munich, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Grill', 'Affiliation': 'Institute for Medical Information Processing, Biometry and Epidemiology, Ludwig-Maximilians-Universität München, Marchioninistr 17, 81377, Munich, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Meyer', 'Affiliation': 'Institute for Health and Nursing Sciences, Medical Faculty, Martin Luther University Halle-Wittenberg, Magdeburger Straße 8, 06112, Halle (Saale), Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Saal', 'Affiliation': 'Institute for Health and Nursing Sciences, Medical Faculty, Martin Luther University Halle-Wittenberg, Magdeburger Straße 8, 06112, Halle (Saale), Germany. susanne.saal@uk-halle.de.'}]",BMC geriatrics,['10.1186/s12877-020-01655-z']
1668,32758152,A randomized crossover trial to assess therapeutic efficacy and cost reduction of acid ursodeoxycholic manufactured by the university hospital for the treatment of primary biliary cholangitis.,"BACKGROUND


Health care costs are growing faster than the rest of the global economy, according to the World Health Organization (WHO). Countries' health expenditures include paying for general medicine, diagnostic procedures, hospitalizations and surgeries, as well as medications and prescribed treatment. Primary biliary cholangitis (PBC) is a rare autoimmune liver disease and the first line available treatment is ursodeoxycholic acid (UDCA), however, direct and indirect treatment costs are expensive. Main aim of this trial was to assess if the therapeutic efficacy of UDCA manufactured by the university hospital is equivalent to that of standard UDCA and treatment cost reduction in patients with PBC.
METHODS


It is a prospective, interventional, randomized, and crossover study in patients diagnosed with PBC. UDCA 300 mg tablets and capsules were developed and manufactured by the university hospital. Thirty patients under treatment with standard UDCA, in stable doses were randomized in sequence A and B, 15 patients in each arm. The groups were treated for 12 weeks and after, the UDCA formulation was changed, following for another 12 weeks of continuous therapy (tablets and capsules / capsules and tablets). Laboratory tests were performed at time T0 (beginning of treatment), T1 (at the 12 week-therapy, before the crossing-over) and T2 (end of treatment). The evaluation was done by comparing the hepatic parameters ALP, GGT, ALT, AST and total bilirubin, also considering the adverse events. The comparison of costs was based on price of the manufactured UDCA and standard UDCA price of the hospital.
RESULTS


Hospital reduced 66.1% the PBC treatment costs using manufactured UDCA. There were no differences in the biochemical parameters between sequence (A and B) and tablets or capsules of UDCA formulations applied in the treatment of PBC.
CONCLUSIONS


The study showed that there was no significant difference between manufactured UDCA (capsule and tablet) and standard UDCA. Hospital reduced the PBC treatment costs using the manufactured UDCA by the university hospital.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03489889 retrospectively registered on January 12th, 2018; Ethics Committee approved the study (ID: 1.790.088) on October 25th, 2016.",2020,"There were no differences in the biochemical parameters between sequence (A and B) and tablets or capsules of UDCA formulations applied in the treatment of PBC.
","['Primary biliary cholangitis (PBC', 'primary biliary cholangitis', 'Thirty patients under treatment with', 'patients diagnosed with PBC', 'patients with PBC']","['acid ursodeoxycholic manufactured', 'UDCA', 'ursodeoxycholic acid (UDCA', 'standard UDCA']","['hepatic parameters ALP, GGT, ALT, AST and total bilirubin', 'manufactured UDCA (capsule and tablet) and standard UDCA']","[{'cui': 'C0008312', 'cui_str': 'Primary biliary cholangitis'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",30.0,0.0305846,"There were no differences in the biochemical parameters between sequence (A and B) and tablets or capsules of UDCA formulations applied in the treatment of PBC.
","[{'ForeName': 'Larissa Akeme', 'Initials': 'LA', 'LastName': 'Nakano', 'Affiliation': 'Department of Gastroenterology, Division of Clinical Gastroenterology and Hepatology, Hospital das Clinicas, University of São Paulo School of Medicine, Av. Dr. Enéas Carvalho de Aguiar, 255, ICHC, 9th Floor, office 9159, São Paulo, SP 05403-000, Brazil.'}, {'ForeName': 'Eduardo Luiz Rachid', 'Initials': 'ELR', 'LastName': 'Cançado', 'Affiliation': 'Department of Gastroenterology, Division of Clinical Gastroenterology and Hepatology, Hospital das Clinicas, University of São Paulo School of Medicine, Av. Dr. Enéas Carvalho de Aguiar, 255, ICHC, 9th Floor, office 9159, São Paulo, SP 05403-000, Brazil.'}, {'ForeName': 'Cleuber Esteves', 'Initials': 'CE', 'LastName': 'Chaves', 'Affiliation': 'Division of Pharmacy of Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil.'}, {'ForeName': 'Maria Cristina Vaz', 'Initials': 'MCV', 'LastName': 'Madeira', 'Affiliation': 'Division of Pharmacy of Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil.'}, {'ForeName': 'Jéssica Toshie', 'Initials': 'JT', 'LastName': 'Katayose', 'Affiliation': 'Division of Pharmacy of Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil.'}, {'ForeName': 'Mariana Akemi', 'Initials': 'MA', 'LastName': 'Nabeshima', 'Affiliation': 'Department of Gastroenterology, Division of Clinical Gastroenterology and Hepatology, Hospital das Clinicas, University of São Paulo School of Medicine, Av. Dr. Enéas Carvalho de Aguiar, 255, ICHC, 9th Floor, office 9159, São Paulo, SP 05403-000, Brazil.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Fossaluza', 'Affiliation': 'Institute of Mathematics and Statistics, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Gabriela Guimarães', 'Initials': 'GG', 'LastName': 'Uhrigshardt', 'Affiliation': 'Institute of Mathematics and Statistics, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Liting', 'Affiliation': 'Institute of Mathematics and Statistics, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Vanusa Barbosa', 'Initials': 'VB', 'LastName': 'Pinto', 'Affiliation': 'Division of Pharmacy of Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil.'}, {'ForeName': 'Flair José', 'Initials': 'FJ', 'LastName': 'Carrilho', 'Affiliation': 'Department of Gastroenterology, Division of Clinical Gastroenterology and Hepatology, Hospital das Clinicas, University of São Paulo School of Medicine, Av. Dr. Enéas Carvalho de Aguiar, 255, ICHC, 9th Floor, office 9159, São Paulo, SP 05403-000, Brazil.'}, {'ForeName': 'Suzane Kioko', 'Initials': 'SK', 'LastName': 'Ono', 'Affiliation': 'Department of Gastroenterology, Division of Clinical Gastroenterology and Hepatology, Hospital das Clinicas, University of São Paulo School of Medicine, Av. Dr. Enéas Carvalho de Aguiar, 255, ICHC, 9th Floor, office 9159, São Paulo, SP 05403-000, Brazil. suzane.ono@fm.usp.br.'}]",BMC gastroenterology,['10.1186/s12876-020-01399-5']
1669,32758173,Prophylactic endovascular balloon occlusion of the aorta in cases of placenta accreta spectrum during caesarean section: points from the anaesthesiologist's perspective.,"BACKGROUND


The placenta accreta spectrum (PAS) is a severe complication of pregnancy and is associated with massive haemorrhage, hysterectomy, and even perinatal maternal-foetal death. Prophylactic abdominal aortic balloon occlusion (PAABO) is a novel and efficient therapy for these patients. The aim of this study was to investigate the benefits, potential risks, and characteristics of anaesthesia management.
METHODS


A total of 48 parturients with PAS were enrolled and divided into two groups. Group A (n = 25) received PAABO, and Group B (n = 23) underwent a normal operative procedure. The characteristics of the general parameters, anaesthesia, and operative procedure were noted. Data on vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) during the operation were recorded. Before and after the procedure, hepatic and renal function and lactate dehydrogenase (LDH) were also measured.
RESULTS


The characteristics of the groups were comparable. PAABO significantly reduced estimated blood loss, which was ≥ 1000 ml. Drastic fluctuations in SBP, DBP and HR were observed during inflation and deflation in Group B. After the operation, increased LDH and glutamic oxaloacetic transaminase (GOT) were observed in both groups, and increased glutamic-pyruvic transaminase (GTP) was observed in Group B.
CONCLUSIONS


PAABO reduced perioperative blood loss and the risk of hysterectomy among parturients with PAS. Sophisticated anaesthetic management should be implemented to prevent or reduce perioperative complications and address internal disorders that are caused by massive blood loss.",2020,"After the operation, increased LDH and glutamic oxaloacetic transaminase (GOT) were observed in both groups, and increased glutamic-pyruvic transaminase (GTP) was observed in Group B.
CONCLUSIONS


PAABO reduced perioperative blood loss and the risk of hysterectomy among parturients with PAS.","['48 parturients with PAS', 'parturients with PAS']","['normal operative procedure', 'Prophylactic abdominal aortic balloon occlusion (PAABO', 'Prophylactic endovascular balloon occlusion']","['glutamic-pyruvic transaminase (GTP', 'systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR', 'perioperative blood loss', 'blood loss', 'LDH and glutamic oxaloacetic transaminase (GOT', 'hepatic and renal function and lactate dehydrogenase (LDH', 'Drastic fluctuations in SBP, DBP and HR']","[{'cui': 'C0032044', 'cui_str': 'Placenta accreta'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0887842', 'cui_str': 'Balloon Occlusion'}]","[{'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}]",48.0,0.0659271,"After the operation, increased LDH and glutamic oxaloacetic transaminase (GOT) were observed in both groups, and increased glutamic-pyruvic transaminase (GTP) was observed in Group B.
CONCLUSIONS


PAABO reduced perioperative blood loss and the risk of hysterectomy among parturients with PAS.","[{'ForeName': 'Haijuan', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Anaesthesiology, Anhui Women and Child Health Care Hospital, 230601, Hefei, China.'}, {'ForeName': 'Shengyou', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Anaesthesiology, Anhui Women and Child Health Care Hospital, 230601, Hefei, China.'}, {'ForeName': 'Jingfa', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Anaesthesiology, Anhui Women and Child Health Care Hospital, 230601, Hefei, China.'}, {'ForeName': 'Lamei', 'Initials': 'L', 'LastName': 'Yao', 'Affiliation': 'Department of Anaesthesiology, Anhui Women and Child Health Care Hospital, 230601, Hefei, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Anaesthesiology, Anhui Women and Child Health Care Hospital, 230601, Hefei, China.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics and Gynecology, Anhui Women and Child Health Care Hospital, 230601, Hefei, China.'}, {'ForeName': 'Xiangdong', 'Initials': 'X', 'LastName': 'Fang', 'Affiliation': 'Department of Anaesthesiology, Anhui Women and Child Health Care Hospital, 230601, Hefei, China. 35880762@qq.com.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03136-y']
1670,32758205,Correction to: Routine versus on demand removal of the syndesmotic screw; a protocol for an international randomised controlled trial (RODEO-trial).,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,[],['syndesmotic screw'],[],[],"[{'cui': 'C0005975', 'cui_str': 'Bone screw'}]",[],,0.118978,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Dingemans', 'Affiliation': 'Department of Surgery, Trauma Unit, Academic Medical Centre, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, The Netherlands.'}, {'ForeName': 'M F N', 'Initials': 'MFN', 'LastName': 'Birnie', 'Affiliation': 'Department of Surgery, Trauma Unit, Academic Medical Centre, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, The Netherlands.'}, {'ForeName': 'F R K', 'Initials': 'FRK', 'LastName': 'Sanders', 'Affiliation': 'Department of Surgery, Trauma Unit, Academic Medical Centre, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, The Netherlands.'}, {'ForeName': 'M P J', 'Initials': 'MPJ', 'LastName': 'van den Bekerom', 'Affiliation': 'Department of Orthopedic Surgery, OLVG, P.O. Box 95500, 1090 HM, Amsterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Backes', 'Affiliation': 'Department of Surgery, Trauma Unit, Academic Medical Centre, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, The Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'van Beeck', 'Affiliation': 'Department of Public Health, Erasmus MC, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands.'}, {'ForeName': 'F W', 'Initials': 'FW', 'LastName': 'Bloemers', 'Affiliation': 'Department of Surgery, Trauma Unit, VU University Medical Centre, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'van Dijkman', 'Affiliation': 'Department of Surgery, Flevo Hospital, P.O. Box 3005, 1300 EG, Almere, The Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Flikweert', 'Affiliation': 'Department of Surgery, Deventer Hospital, P.O. Box 5001, 7400 GC, Deventer, The Netherlands.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Haverkamp', 'Affiliation': 'Department of Surgery, Slotervaart Hospital, P.O. Box 90440, 1006 BK, Amsterdam, The Netherlands.'}, {'ForeName': 'H R', 'Initials': 'HR', 'LastName': 'Holtslag', 'Affiliation': 'Department of Surgery, Trauma Unit, Academic Medical Centre, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, The Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Hoogendoorn', 'Affiliation': 'Department of Surgery, Haaglanden MC, P.O. Box 432, 2501 CK, The Hague, The Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Joosse', 'Affiliation': 'Department of Surgery, Noordwest Hospital Group, P.O. Box 501, 1815 JD, Alkmaar, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Parkkinen', 'Affiliation': 'Department of Orthopaedics and Traumatology, Helsinki University Hospital, Topeliuksenkatu 5, 00260, Helsinki, Finland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Roukema', 'Affiliation': 'Department of Surgery, Maasstad Hospital, P.O. Box 9100, 3007 AC, Rotterdam, The Netherlands.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Sosef', 'Affiliation': 'Department of Surgery, Spaarne Hospital, P.O. Box 770, 2130 AT, Hoofddorp, The Netherlands.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Twigt', 'Affiliation': 'Department of Surgery, BovenIJ Hospital, P.O. Box 37610, 1030 BD, Amsterdam, The Netherlands.'}, {'ForeName': 'R N', 'Initials': 'RN', 'LastName': 'van Veen', 'Affiliation': 'Department of Surgery, OLVG, P.O. Box 95500, 1090 HM, Amsterdam, The Netherlands.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'van der Veen', 'Affiliation': 'Department of Surgery, Catharina Hospital, P.O. Box 1350, 5602 ZA, Eindhoven, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Vermeulen', 'Affiliation': 'Department of Surgery, Spaarne Hospital, P.O. Box 770, 2130 AT, Hoofddorp, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Winkelhagen', 'Affiliation': 'Department of Surgery, Westfries Hospital, P.O. Box 600, 1620 AR, Hoorn, The Netherlands.'}, {'ForeName': 'B C', 'Initials': 'BC', 'LastName': 'van der Zwaard', 'Affiliation': ""Department of Orthopaedics, Jeroen Bosch Hospital, P.O. Box 90153, 5200 ME, 's-Hertogenbosch, The Netherlands.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'van Dieren', 'Affiliation': 'Department of Surgery, Trauma Unit, Academic Medical Centre, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, The Netherlands.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Goslings', 'Affiliation': 'Department of Orthopedic Surgery, OLVG, P.O. Box 95500, 1090 HM, Amsterdam, The Netherlands.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Schepers', 'Affiliation': 'Department of Surgery, Trauma Unit, Academic Medical Centre, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, The Netherlands. t.schepers@amc.nl.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03516-7']
1671,32762224,Influence of high-intensity intermittent training on glycolipid metabolism in obese male college students.,"BACKGROUND


Obesity is a chronic metabolic disease that increases the risk of developing health problems including respiratory disease, hypertension, hyperlipidemia, diabetes, and coronary heart disease. In college students, as well as impacting physical health, obesity can also affect mental health and even students' future careers. Aerobic exercise is an effective way of achieving weight loss; however, for some students, it cannot be maintained over the long term. This study aimed to observe and analyze the influence of high-intensity intermittent training on glycolipid metabolism in obese male college students.
METHODS


A total of 300 obese male college students were enrolled in the study and were randomly divided into the study group and the control group (150 cases in each group). Over 12 weeks, the control group was given routine aerobic exercise intervention, while the study group was given high-intensity intermittent training. The blood sugar level, blood lipid level, and body measurements of the students were measured before and after intervention and compared between the two groups.
RESULTS


After 12 weeks of intervention, the body weight, waist circumference, waist-hip ratio, body mass index (BMI), body fat rate (BFR), serum level of insulin, low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC) and triglyceride (TG) of the college students were significantly lower than before intervention, and the differences were statistically significant (P<0.05). There were no significant differences in body weight, waist circumference, waist-hip ratio, BMI, or BFR between the two groups (P>0.05). The study group had significantly lower serum levels of TC, TG, and insulin than the control group, and the differences were statistically significant (P<0.05).
CONCLUSIONS


Aerobic exercise and high-intensity intermittent training both significantly improved the body shape of obese male college students. However, high-intensity intermittent training improved the glycolipid metabolism of obese male college students to a greater extent than aerobic exercise did.",2020,"There were no significant differences in body weight, waist circumference, waist-hip ratio, BMI, or BFR between the two groups (P>0.05).","['300 obese male college students', 'obese male college students', 'college students']","['Aerobic exercise', 'Aerobic exercise and high-intensity intermittent training', 'high-intensity intermittent training', 'routine aerobic exercise intervention']","['blood sugar level, blood lipid level, and body measurements of the students', 'body weight, waist circumference, waist-hip ratio, body mass index (BMI), body fat rate (BFR), serum level of insulin, low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC) and triglyceride (TG) of the college students', 'body weight, waist circumference, waist-hip ratio, BMI, or BFR', 'serum levels of TC, TG, and insulin', 'glycolipid metabolism', 'body shape']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0203910', 'cui_str': 'Body measurement'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0017950', 'cui_str': 'Glycolipid'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}]",300.0,0.0200114,"There were no significant differences in body weight, waist circumference, waist-hip ratio, BMI, or BFR between the two groups (P>0.05).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Qufu Normal University, Qufu 273165, China.'}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Qufu Normal University, Qufu 273165, China.'}, {'ForeName': 'Zhengzheng', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': 'Qufu Normal University, Qufu 273165, China.'}, {'ForeName': 'Xuelin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Qufu Normal University, Qufu 273165, China. xuezhezhang@yeah.net.'}]",Annals of palliative medicine,['10.21037/apm-20-1105']
1672,32762229,A randomized clinical study of the treatment of white lesions of the vulva with a fractional ultrapulsed CO2 laser.,"BACKGROUND


White lesions of the vulva are a common vulvar disease of unclear etiology. Although a variety of treatments have been used to treat the disease in clinical practice, there is currently a lack of effective radical therapies. This study aimed to compare the feasibility and effectiveness of fractional ultrapulsed CO2 laser with that of high-intensity focused ultrasound in the treatment of white lesions of the vulva.
METHODS


A total of 60 patients with pruritus vulvae who were treated at the Center for Diagnosis and Treatment of Cervical Diseases in our hospital between December, 2017, and December 2018 were enrolled in this study. The possibility of malignant lesions of the vulva was ruled out by histopathological diagnosis following colposcopic biopsy. The patients were randomly divided into two groups: a laser treatment group (group L, n=30) and a focused ultrasound treatment group (group U, n=30). The patients were monitored for changes in signs and symptoms during and after treatment, and the treatment outcomes of the two groups were compared.
RESULTS


The local symptoms of pruritus were alleviated by both the fractional ultrapulsed CO2 laser and high-intensity focused ultrasound. The patients in group L had no significant adverse reactions during the operation and needed no special postoperative treatment. The total effective rate in group L was 96.7%. In group U, five patients felt mild burning during the operation, painful blisters arose on the skin of the ablated area, and long-lasting local edema was observed. Seven patients had subcutaneous nodules. The total effective rate in group U was 90.0%.
CONCLUSIONS


Fractional ultrapulsed CO2 laser is a minimally invasive, effective, and safe treatment for white lesions of the vulva. It causes few complications and does not affect the daily and working life of patients. Therefore, it should be widely applied in clinical practice.",2020,"CONCLUSIONS


Fractional ultrapulsed CO2 laser is a minimally invasive, effective, and safe treatment for white lesions of the vulva.","['Seven patients had subcutaneous nodules', '60 patients with pruritus vulvae who were treated at the Center for Diagnosis and Treatment of Cervical Diseases in our hospital between December, 2017, and December 2018 were enrolled in this study', 'white lesions of the vulva', 'white lesions of the vulva with a fractional ultrapulsed CO2 laser']","['fractional ultrapulsed CO2 laser', 'Fractional ultrapulsed CO2 laser', 'laser treatment group']","['total effective rate', 'adverse reactions', 'local symptoms of pruritus']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0151811', 'cui_str': 'Subcutaneous nodule'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033778', 'cui_str': 'Pruritus of vulva'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007867', 'cui_str': 'Disorder of uterine cervix'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0042993', 'cui_str': 'Vulval structure'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}]","[{'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033774', 'cui_str': 'Itching'}]",60.0,0.0199897,"CONCLUSIONS


Fractional ultrapulsed CO2 laser is a minimally invasive, effective, and safe treatment for white lesions of the vulva.","[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Center for Diagnosis and Treatment of Cervical Diseases, Changzhou Maternal and Child Health Care Hospital, Nanjing Medical University, Changzhou, China.'}, {'ForeName': 'Yiqing', 'Initials': 'Y', 'LastName': 'Lai', 'Affiliation': 'Center for Diagnosis and Treatment of Cervical Diseases, Changzhou Maternal and Child Health Care Hospital, Nanjing Medical University, Changzhou, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wan', 'Affiliation': 'Center for Diagnosis and Treatment of Cervical Diseases, Changzhou Maternal and Child Health Care Hospital, Nanjing Medical University, Changzhou, China.'}, {'ForeName': 'Beibei', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Center for Diagnosis and Treatment of Cervical Diseases, Changzhou Maternal and Child Health Care Hospital, Nanjing Medical University, Changzhou, China.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Qiang', 'Affiliation': 'Department of Pathology, Changzhou Maternal and Child Care Health Hospital, Nanjing Medical University, Changzhou, China.'}, {'ForeName': 'Sumei', 'Initials': 'S', 'LastName': 'Ge', 'Affiliation': 'Department of Pathology, Changzhou Maternal and Child Care Health Hospital, Nanjing Medical University, Changzhou, China.'}, {'ForeName': 'Keliang', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Center for Diagnosis and Treatment of Cervical Diseases, Changzhou Maternal and Child Health Care Hospital, Nanjing Medical University, Changzhou, China. keliangzhang@njmu.edu.cn.'}, {'ForeName': 'Zhilei', 'Initials': 'Z', 'LastName': 'Mao', 'Affiliation': 'Center for Diagnosis and Treatment of Cervical Diseases, Changzhou Maternal and Child Health Care Hospital, Nanjing Medical University, Changzhou, China. mao598808386@126.com.'}]",Annals of palliative medicine,['10.21037/apm-20-1085']
1673,32729342,Dehydrated human amnion and chorion allograft versus standard of care alone in treatment of Wagner 1 diabetic foot ulcers: a trial-based health economics study.,"AIMS


The aim of this health economics study was to estimate the cost-utility of an aseptically processed, dehydrated human amnion and chorion allograft (dHACA) plus standard of care (SOC) (group 1) versus SOC alone (group 2) based on a published randomized controlled trial in which patients who had an eligible Wagner 1 diabetic foot ulcer wound were randomized to either of these treatments.
MATERIALS AND METHODS


A Markov microsimulation was used to project trial results out to a 1-year horizon time with a third-party payer perspective. The starting health state was an unhealed non-infected ulcer with other health states of healed ulcer, infected non-healed ulcer, cellulitis, osteomyelitis, and absorbing states of dead or amputation. All patients started with unhealed non-infected ulcers at cycle 0. Costs were incurred by patients for procedures at hospital outpatient wound care provider-based departments (PBDs) and hospitals (if complications occurred) and were calculated using time-based activity costing methods. Effectiveness units were quality-adjusted life years (QALYs) computed from literature utility values. One-way and probabilistic sensitivity analysis (PSA) were also conducted.
RESULTS


After 1 year, the calculated incremental cost-effectiveness ratio (ICER) for group 1 versus group 2 was -$4,373 with group 1 (dHACA) being dominant over group 2 (SOC). PSA demonstrated that group 1 had 69.2% lower cost values with increased positive incremental effectiveness for 94.9% of values. A willingness to pay (WTP) curve showed that about 92% of interventions were cost effective for group 1 when $50,000 was paid.
CONCLUSIONS


The results of this study demonstrated that dHACA added to SOC compared to SOC alone was extremely cost-effective in the defined trial population.",2020,PSA demonstrated that group 1 had 69.2% lower cost values with increased positive incremental effectiveness for 94.9% of values.,"['Wagner 1 diabetic foot ulcers', 'patients who had an eligible Wagner 1 diabetic foot ulcer wound']","['Dehydrated human amnion and chorion allograft versus standard of care alone', 'aseptically processed, dehydrated human amnion and chorion allograft (dHACA) plus standard of care (SOC', 'SOC', 'dHACA', 'SOC alone']","['calculated incremental cost-effectiveness ratio (ICER', 'cost effective']","[{'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021501', 'cui_str': 'wounds'}]","[{'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C0008503', 'cui_str': 'Chorionic structure'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0820619,PSA demonstrated that group 1 had 69.2% lower cost values with increased positive incremental effectiveness for 94.9% of values.,"[{'ForeName': 'Marissa J', 'Initials': 'MJ', 'LastName': 'Carter', 'Affiliation': 'Strategic Solutions, Inc, Bozeman, MT, USA.'}]",Journal of medical economics,['10.1080/13696998.2020.1803888']
1674,32730842,The association between REM sleep and decision-making: Supporting evidences.,"Studies suggest that REM sleep is important for the maintenance of prefrontal cortex functioning. Therefore, reducing REM sleep may have an impact on cognitive functions such as impulse control and decision-making processes. This study examined the association between impulsiveness and sensation seeking personality traits, REM sleep and performance on a decision-making computer task following a habitual night of sleep and a partial sleep deprivation (PSD) condition with advanced wake-up time. Eighteen young adults participated in two experimental conditions: a control (habitual bedtime and wake time) and a 50% PSD with an advanced wake time. Impulsiveness and sensation seeking personality traits were measured with a personality inventory (NEO-PI-3), sleep was assessed using standard polysomnography and the Iowa Gambling Task (IGT) was completed at noon following each sleep condition. Results showed that when sleep deprived, participants choose more often to play riskier decks of cards during the last half of the IGT. Results also showed that REM sleep duration and REM sleep deprivation were associated with riskier decisions on the IGT. Moreover, impulsiveness was associated with riskier decisions after a normal night of sleep. These findings suggest that REM sleep duration and impulsiveness are important factors to consider while investigating decision-making processes under conditions of uncertainty and risk.",2020,"Results showed that when sleep deprived, participants choose more often to play riskier decks of cards during the last half of the IGT.",['Eighteen young adults'],['control (habitual bedtime and wake time) and a 50% PSD with an advanced wake time'],"['personality inventory (NEO-PI-3), sleep was assessed using standard polysomnography and the Iowa Gambling Task (IGT', 'REM sleep duration and REM sleep deprivation', 'Impulsiveness and sensation seeking personality traits']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0142580', 'cui_str': 'PI3 protein, human'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0037322', 'cui_str': 'Rapid eye movement sleep'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0751506', 'cui_str': 'REM Sleep Deprivation'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0871336', 'cui_str': 'Sensation seeking'}, {'cui': 'C0233849', 'cui_str': 'Character trait finding'}]",18.0,0.0117207,"Results showed that when sleep deprived, participants choose more often to play riskier decks of cards during the last half of the IGT.","[{'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Brunet', 'Affiliation': 'Laboratoire du Sommeil, Département de Psychoéducation et de Psychologie, Université du Québec en Outaouais, Gatineau, Canada, J8X 3X7.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'McNeil', 'Affiliation': 'Behavioral and Metabolic Research Unit, School of Human Kinetics, University of Ottawa, Ottawa, Canada, K1N 6N5.'}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Doucet', 'Affiliation': 'Behavioral and Metabolic Research Unit, School of Human Kinetics, University of Ottawa, Ottawa, Canada, K1N 6N5.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Forest', 'Affiliation': 'Laboratoire du Sommeil, Département de Psychoéducation et de Psychologie, Université du Québec en Outaouais, Gatineau, Canada, J8X 3X7. Electronic address: genevieve.forest@uqo.ca.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113109']
1675,32738365,"Acupressure as an adjunct to pharmacological treatment for depression, anxiety and stress in knee osteoarthritis patients.","BACKGROUND


Osteoarthritis is the most common type of arthritis. Depression, anxiety and stress are associated with knee osteoarthritis.
OBJECTIVES


To check the effectiveness of acupressure therapy with pharmacological treatment on pain, depression, anxiety and stress in knee osteoarthritis patients. To assess the effect of pain improvement on psychological health.
METHODS


Eligible 212 knee osteoarthritis patients were divided into two groups (intervention and control group). The intervention group (n = 106) received acupressure therapy in combination with pharmacological treatment, while control group (n = 106) continued pharmacological treatment only. Pain and psychological symptoms were measured using Visual analogue scale and Depression Anxiety Stress Scale-21. Pearson's correlation was used to check the effect of pain improvement on psychological health.
RESULTS


Patients of both groups reported severe pain initially. On analyzing the results after completion of the study it was found that patients in intervention group scored better on pain scale (p ˂ 0.001) and DASS-21 scale (p = ˂0.0001). However, it may be noted that reduction in DASS-21 score was not found to be significant for control group (p = 0.08). Pearson's correlation coefficients value ranged from 0.231 to 0.412 for DASS-21 scale (p ˂ 0.05).
CONCLUSIONS


On analysis it can be concluded that acupressure can be used as add on therapy in combination with conventional treatment (pharmacological treatment) which may assist in pain reduction. The reduction in pain directly contributes in improving the physiological wellness among knee osteoarthritis patients.",2020,However it may be noted that reduction in DASS-21 score was not found to be significant for control group (p=0.08).,"['knee osteoarthritis patients', 'Eligible 212 knee osteoarthritis patients']","['acupressure therapy in combination with pharmacological treatment, while control group (n=106) continued pharmacological treatment only', 'acupressure', 'acupressure therapy with pharmacological treatment']","['psychological health', 'pain, depression, anxiety and stress', 'pain improvement on psychological health', 'DASS-21 score', 'Pain and psychological symptoms', 'DASS-21 scale', 'psychological symptoms', 'Visual analogue scale and Depression Anxiety Stress Scale-21', 'depression, anxiety and stress', 'severe pain', 'pain scale']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}]",212.0,0.0150036,However it may be noted that reduction in DASS-21 score was not found to be significant for control group (p=0.08).,"[{'ForeName': 'Meenu', 'Initials': 'M', 'LastName': 'Rani', 'Affiliation': 'Department of Pharmacology, Sawai Man Singh Medical College, Jaipur, Rajasthan- 302004, India. Electronic address: meenusaharan23@gmail.com.'}, {'ForeName': 'Lokendra', 'Initials': 'L', 'LastName': 'Sharma', 'Affiliation': 'Department of Pharmacology, Sawai Man Singh Medical College, Jaipur, Rajasthan- 302004, India. Electronic address: drlokendra29@gmail.com.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Advani', 'Affiliation': 'Department of Pharmacology, Sawai Man Singh Medical College, Jaipur, Rajasthan- 302004, India. Electronic address: drupadvani@gmail.com.'}, {'ForeName': 'Susheel', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Department of Pharmacology, Sawai Man Singh Medical College, Jaipur, Rajasthan- 302004, India. Electronic address: susheelpn72@gmail.com.'}]",Journal of acupuncture and meridian studies,['10.1016/j.jams.2020.07.001']
1676,32744426,Effectiveness of a couple-based psychosocial intervention on patients with prostate cancer and their partners: A quasi-experimental study.,"AIMS


To understand the effectiveness of a couple-based psychosocial information package (PIP) and multimedia psychosocial intervention (MPI) on patients with prostate cancer and their partners.
DESIGN


A random assignment and quasi-experimental design were used.
METHODS


From August 2015-March 2018, 103 newly diagnosed patients with prostate cancer and their partners were divided into a control group (CG) (N = 50), PIP group (N = 25) and MPI group (N = 28). The CG received usual care, the PIP group received information manuals and telephone counselling for 6-week and the MPI group received multimedia films and manuals and professional support for 6 weeks. The three groups were posttested 6, 10, 18 and 24 weeks after the pre-test. The outcome measurements included disease appraisals, emotion status, relationship satisfaction, health-related quality of life (HRQOL) and satisfaction with MPI.
RESULTS/FINDINGS


Partners in the MPI and PIP groups experienced significant improvements in positive and negative affect or mental HRQOL as compared with the CG. The effectiveness of MPI and PIP on negative affect, mental HRQOL, however, were not statistically significant in patients with prostate cancer. Nevertheless, patients were satisfied with the MPI.
CONCLUSION


Nurses can provide different types of interventions for partners, depending on personal preferences and available resources.
IMPACT


There is a lack of studies that focus on the effectiveness of couple-based psychosocial intervention on both the patients with prostate cancer and their partners in Asia. Partners in the multimedia psychosocial intervention group and psychosocial information package group experienced improvements in positive affect, negative affect or health-related quality of life as compared with the control group. Patients in both intervention groups experienced similar negative affect and health-related quality of life as compared with the control group. The couple-based psychosocial interventions can be provided by nurses based on partners' preferences and available resources.",2020,"Partners in the multimedia psychosocial intervention group and psychosocial information package group experienced improvements in positive affect, negative affect or health-related quality of life as compared with the control group.","['patients with prostate cancer', 'patients with prostate cancer and their partners', 'From August 2015-March 2018', 'patients with prostate cancer and their partners in Asia', '103 newly diagnosed patients with prostate cancer and their partners']","['control group (CG', 'couple-based psychosocial intervention', 'couple-based psychosocial information package (PIP) and multimedia psychosocial intervention (MPI', 'multimedia psychosocial intervention group and psychosocial information package', 'PIP group received information manuals and telephone counselling for 6-week and the MPI group received multimedia films and manuals and professional support for 6\xa0weeks', 'PIP group']","['positive and negative affect or mental HRQOL', 'disease appraisals, emotion status, relationship satisfaction, health-related quality of life (HRQOL) and satisfaction with MPI', 'positive affect, negative affect or health-related quality of life', 'negative affect and health-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.0174023,"Partners in the multimedia psychosocial intervention group and psychosocial information package group experienced improvements in positive affect, negative affect or health-related quality of life as compared with the control group.","[{'ForeName': 'Ching-Hui', 'Initials': 'CH', 'LastName': 'Chien', 'Affiliation': 'College of Nursing, National Taipei University of Nursing and Health Sciences, Taipei CIty, Taiwan.'}, {'ForeName': 'Hsiao-Jen', 'Initials': 'HJ', 'LastName': 'Chung', 'Affiliation': 'Department of Urology, Taipei Veterans General Hospital, Taipei City, Taiwan.'}, {'ForeName': 'Kuan-Lin', 'Initials': 'KL', 'LastName': 'Liu', 'Affiliation': 'Division of Urology, Department of Surgery, Chang Gung Memorial Hospital at Keelung, Kee-Lung City, Taiwan.'}, {'ForeName': 'See-Tong', 'Initials': 'ST', 'LastName': 'Pang', 'Affiliation': 'Division of Urology, Department of Surgery, Chang Gung Memorial Hospital at Linkou, Tao-Yuan City, Taiwan.'}, {'ForeName': 'Chun-Te', 'Initials': 'CT', 'LastName': 'Wu', 'Affiliation': 'Division of Urology, Department of Surgery, Chang Gung Memorial Hospital at Keelung, Kee-Lung City, Taiwan.'}, {'ForeName': 'Ying-Hsu', 'Initials': 'YH', 'LastName': 'Chang', 'Affiliation': 'College of Medicine, Chang Gung University, Tao-Yuan City, Taiwan.'}, {'ForeName': 'Xuan-Yi', 'Initials': 'XY', 'LastName': 'Huang', 'Affiliation': 'College of Nursing, National Taipei University of Nursing and Health Sciences, Taipei CIty, Taiwan.'}, {'ForeName': 'Yen-Hwa', 'Initials': 'YH', 'LastName': 'Chang', 'Affiliation': 'Department of Urology, Taipei Veterans General Hospital, Taipei City, Taiwan.'}, {'ForeName': 'Tzu-Ping', 'Initials': 'TP', 'LastName': 'Lin', 'Affiliation': 'Department of Urology, Taipei Veterans General Hospital, Taipei City, Taiwan.'}, {'ForeName': 'Wei-Yu', 'Initials': 'WY', 'LastName': 'Lin', 'Affiliation': 'College of Medicine, Chang Gung University, Tao-Yuan City, Taiwan.'}, {'ForeName': 'Cheng-Keng', 'Initials': 'CK', 'LastName': 'Chuang', 'Affiliation': 'Division of Urology, Department of Surgery, Chang Gung Memorial Hospital at Linkou, Tao-Yuan City, Taiwan.'}]",Journal of advanced nursing,['10.1111/jan.14471']
1677,32739495,Design and rationale of a multicenter defeat alcoholic steatohepatitis trial: (DASH) randomized clinical trial to treat alcohol-associated hepatitis.,"BACKGROUND/AIMS


Despite high mortality of alcohol-associated hepatitis, there has been limited advancement in treatment strategies. Defeat Alcoholic Steatohepatitis (DASH) is a multicenter, randomized, double-blind controlled trial whose primary objective was to evaluate the safety and efficacy of a novel combination of 3 drugs targeting different perturbations in AH.
METHODS


Severe AH was diagnosed by liver biopsy or clinical and biochemical criteria and model for end stage liver disease (MELD) score ≥ 20 stratified by MELD scores (20-25 and ≥ 26) and randomized to a combination of an interleukin receptor 1 antagonist, Anakinra(100 mg daily for 14 days) to suppress acute inflammation, pentoxifylline (400 mg three times a day for 28 days) to prevent hepatorenal syndrome, and zinc sulfate (220 mg orally once daily for 6 months) or the standard of care therapy including methylprednisolone 32 mg orally once daily for 28 days. The primary efficacy outcome was the unadjusted log-rank test of the Kaplan-Meier survival estimates for the two treatment groups at 180 days.
RESULTS


Between July 2012 to March 2018, 500 subjects with severe AH were screened of which 104 subjects were enrolled with MELD score of 25.6 ± 3.2 (20.0-35.0) in the investigational arm and 25.8 ± 4.5 (20.0-40.0) in the standard of care arm. Causes of screen failures included not meeting eligibility criteria (n = 347), declining to participate (n = 39), and other reasons (n = 10).
CONCLUSIONS


Data from the DASH consortium studies will determine if a combination of drugs targeting multiple mechanisms of injury in the severe AH will improve clinical outcomes.",2020,"The primary efficacy outcome was the unadjusted log-rank test of the Kaplan-Meier survival estimates for the two treatment groups at 180 days.
","['Between July 2012 to March 2018, 500 subjects with severe AH were screened of which 104 subjects were enrolled with MELD score of 25.6\u202f±\u202f3.2 (20.0-35.0) in the investigational arm and 25.8\u202f±\u202f4.5 (20.0-40.0) in the standard of care arm', 'Severe AH was diagnosed by liver biopsy or clinical and biochemical criteria and model for end stage liver disease (MELD) score\u202f≥']","['interleukin receptor 1 antagonist, Anakinra(100\u202fmg daily for 14\u202fdays) to suppress acute inflammation, pentoxifylline', 'zinc sulfate (220\u202fmg orally once daily for 6\u202fmonths) or the standard of care therapy including methylprednisolone']","['safety and efficacy', 'unadjusted log-rank test of the Kaplan-Meier survival estimates']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C4048785', 'cui_str': 'Model for end stage liver disease score'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0193388', 'cui_str': 'Biopsy of liver'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3826979', 'cui_str': 'Model for end-stage liver disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0206553', 'cui_str': 'Interleukin Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0333361', 'cui_str': 'Acute inflammation'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0078794', 'cui_str': 'Zinc Sulfate'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",104.0,0.725088,"The primary efficacy outcome was the unadjusted log-rank test of the Kaplan-Meier survival estimates for the two treatment groups at 180 days.
","[{'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Dasarathy', 'Affiliation': 'Cleveland Clinic, USA. Electronic address: dasaras@ccf.org.'}, {'ForeName': 'Mack C', 'Initials': 'MC', 'LastName': 'Mitchell', 'Affiliation': 'University of Texas at Southwestern University, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Barton', 'Affiliation': 'University of Massachusetts, USA.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'McClain', 'Affiliation': 'University of Louisville, USA.'}, {'ForeName': 'Gyongyi', 'Initials': 'G', 'LastName': 'Szabo', 'Affiliation': 'Harvard Medical School & Beth Israel Deaconess Medical Center, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Nagy', 'Affiliation': 'Cleveland Clinic, USA.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Radaeva', 'Affiliation': 'National Institute of Alcohol Abuse and Alcoholism, USA.'}, {'ForeName': 'Arthur J', 'Initials': 'AJ', 'LastName': 'McCullough', 'Affiliation': 'Cleveland Clinic, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106094']
1678,32739611,Changes in technology acceptance among older people with dementia: the role of social robot engagement.,"OBJECTIVE


Emerging technologies such as social robots have shown to be effective in reducing loneliness and agitation for older people with dementia. However, the acceptance of technology (specifically social robots) was found to be low for older people with dementia. The current understanding of changes in technology acceptance following direct exposure is limited and lacks rigorous study design. This study examined the change in technology acceptance after a direct interaction with a humanoid social robot (Kabochan) that was deployed for long-term care facilities' residents with dementia.
METHODS


The technology acceptance was assessed using randomised control trials for a time frame of 32 weeks. A total of 103 residents clinically diagnosed with dementia, with a mean age of 87.2 years (SD = 7.4), were recruited from seven long-term care facilities in Hong Kong and were randomly allocated to either Kabochan-engagement group or control group. Participants in the engagement group interacted with Kabochan in an individual, non-facilitated approach. The behavioural engagement with Kabochan was observed by care workers and recorded into constructive engagement and non-engagement. Questionnaire surveys were taken placed at pre- and post-exposure with Kabochan to measure attitudes and beliefs towards technology. The questionnaire was based on previous studies on technology acceptance and included attitudes towards technology, perceived usefulness, perceived ease of use, technology self-efficacy, technology anxiety, and facilitating conditions.
RESULTS


Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2  = 0.043) in comparison to usual care group. Results further demonstrated that the magnitude of belief changes was related to the intensity of constructive behavioural engagement. Specifically, resident-robot behavioural engagement moderately improved attitudes towards technology (F = 11.62, p < 0.001, η p 2  = 0.11) and perceived usefulness (F = 5.75, p = 0.02, η p 2  = 0.06).
CONCLUSIONS


The study tentatively supports that exposure to Kabochan has potential for changing perceived ease of use but not for other beliefs and attitudes towards technology among long-term care residents with dementia. Direct engagement with a humanoid social robot might be promising in improving the perceived ease of use towards technology.",2020,"Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2  = 0.043) in comparison to usual care group.","['103 residents clinically diagnosed with dementia, with a mean age of 87.2 years (SD = 7.4), were recruited from seven long-term care facilities in Hong Kong', ""long-term care facilities' residents with dementia"", 'older people with dementia']","['humanoid social robot (Kabochan', 'humanoid social robot', 'Kabochan-engagement group or control group', 'Kabochan']","['Perceived ease of use', 'attitudes towards technology']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]",103.0,0.0256322,"Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2  = 0.043) in comparison to usual care group.","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ke', 'Affiliation': 'Sau Po Centre on Ageing, the University of Hong Kong, Hong Kong. Electronic address: kechen@hku.hk.'}, {'ForeName': 'Vivian Wei-Qun', 'Initials': 'VW', 'LastName': 'Lou', 'Affiliation': 'Sau Po Centre on Ageing, the University of Hong Kong, Hong Kong; Social Work and Social Administration, the University of Hong Kong, Pok Fu Lam, Hong Kong. Electronic address: wlou@hku.hk.'}, {'ForeName': 'Kelvin Cheng-Kian', 'Initials': 'KC', 'LastName': 'Tan', 'Affiliation': 'Social Work and Social Administration, the University of Hong Kong, Pok Fu Lam, Hong Kong. Electronic address: u3004055@connect.hku.hk.'}, {'ForeName': 'Man Yi', 'Initials': 'MY', 'LastName': 'Wai', 'Affiliation': 'Hong Kong Sheng Kung Hui Welfare Council Ltd, Hong Kong. Electronic address: gwai@skhwc.org.hk.'}, {'ForeName': 'Lai Lok', 'Initials': 'LL', 'LastName': 'Chan', 'Affiliation': 'Hong Kong Sheng Kung Hui Welfare Council Ltd, Hong Kong. Electronic address: llchan@skhwc.org.hk.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104241']
1679,32740188,Nurse-Implemented Goal-Directed Strategy to Improve Pain and Sedation Management in a Pediatric Cardiac ICU.,"OBJECTIVES


To assess the impact of a nurse-implemented goal-directed sedation strategy on patient care and nursing practice in a pediatric cardiac ICU.
DESIGN


Quality improvement project with a pre-post interval measurement plan.
SETTING


Thirty-one bed pediatric cardiac ICU in a freestanding tertiary care children's hospital.
PATIENTS


Postoperative pediatric cardiac surgery patients.
INTERVENTIONS


The implementation of cardiac-Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE), a nurse-implemented goal directed strategy to improve pain and sedation management in a pediatric cardiac ICU which included daily team discussion of the patient's trajectory of illness (acute, titration, or weaning phase), prescription of a sedation target score based on the patient's trajectory of illness, arousal assessments, and opioid and/or sedative titration. Withdrawal Assessment Scores were used to assess and manage iatrogenic withdrawal symptoms.
MEASUREMENTS AND MAIN RESULTS


Data related to opioid and sedation use, pain and sedation scores, and the occurrence and management of iatrogenic withdrawal symptoms were reviewed on 1,243 patients during four separate time periods: one pre-implementation and three discontinuous post-implementation time intervals. Patient age and complexity were consistent across the data collection periods. Post-implementation opioids and benzodiazepines use was reduced about 50% without a concomitant increase in the use of other sedative classes. Few post-intervention patients were discharged from the pediatric cardiac ICU or to home on methadone (pediatric cardiac ICU: pre 19% to post 3%; hospital: pre 12% to post 1.3%). Documentation of pain, sedation, and withdrawal scores became more consistent and nurses reported satisfaction with their patient's comfort management.
CONCLUSIONS


The implementation of a nurse-driven goal-directed plan such as cardiac-RESTORE to manage pediatric cardiac ICU patient pain and sedation is possible, sustainable, and associated with reduced sedative and methadone use.",2020,Post-implementation opioids and benzodiazepines use was reduced about 50% without a concomitant increase in the use of other sedative classes.,"['Postoperative pediatric cardiac surgery patients', ""Thirty-one bed pediatric cardiac ICU in a freestanding tertiary care children's hospital""]","['benzodiazepines', 'Sedation Titration', 'nurse-implemented goal-directed sedation strategy']","['Withdrawal Assessment Scores', 'opioid and sedation use, pain and sedation scores, and the occurrence and management of iatrogenic withdrawal symptoms', 'Documentation of pain, sedation, and withdrawal scores']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0179281', 'cui_str': 'Pediatric bed'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}]","[{'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}]",1243.0,0.0880508,Post-implementation opioids and benzodiazepines use was reduced about 50% without a concomitant increase in the use of other sedative classes.,"[{'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Lincoln', 'Affiliation': ""1Department of Cardiovascular and Critical Care Nursing Services, Boston Children's Hospital, Boston, MA. 2Department of Cardiology, Boston Children's Hospital, Boston, MA. 3Information Services Department, Clinical Integration Architect, Boston Children's Hospital, Boston, MA. 4Department of Pediatrics, Harvard School of Medicine, Boston, MA. 5Department of Cardiovascular Services, Boston Children's Hospital, Boston, MA. 6Department of Family and Community Health, School of Nursing, University of Pennsylvania, Philadelphia, PA. 7Department of Anesthesia and Critical Care, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA. 8Research Institute, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Whelan', 'Affiliation': ''}, {'ForeName': 'Lauren P', 'Initials': 'LP', 'LastName': 'Hartwell', 'Affiliation': ''}, {'ForeName': 'Kimberlee', 'Initials': 'K', 'LastName': 'Gauvreau', 'Affiliation': ''}, {'ForeName': 'Brenda L', 'Initials': 'BL', 'LastName': 'Dodsen', 'Affiliation': ''}, {'ForeName': 'Joan M', 'Initials': 'JM', 'LastName': 'LaRovere', 'Affiliation': ''}, {'ForeName': 'Ravi R', 'Initials': 'RR', 'LastName': 'Thiagarajan', 'Affiliation': ''}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Hickey', 'Affiliation': ''}, {'ForeName': 'Martha A Q', 'Initials': 'MAQ', 'LastName': 'Curley', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002505']
1680,32740192,Dexmedetomidine Sedation in Mechanically Ventilated Critically Ill Children: A Pilot Randomized Controlled Trial.,"OBJECTIVES


To assess the feasibility, safety, and efficacy of a sedation protocol using dexmedetomidine as the primary sedative in mechanically ventilated critically ill children.
DESIGN


Open-label, pilot, prospective, multicenter, randomized, controlled trial. The primary outcome was the proportion of sedation scores in the target sedation range in the first 48 hours. Safety outcomes included device removal, adverse events, and vasopressor use. Feasibility outcomes included time to randomization and protocol fidelity.
SETTING


Six tertiary PICUs in Australia and New Zealand.
PATIENTS


Critically ill children, younger than 16 years old, requiring intubation and mechanical ventilation and expected to be mechanically ventilated for at least 24 hours.
INTERVENTIONS


Children randomized to dexmedetomidine received a dexmedetomidine-based algorithm targeted to light sedation (State Behavioral Scale -1 to +1). Children randomized to usual care received sedation as determined by the treating clinician (but not dexmedetomidine), also targeted to light sedation.
MEASUREMENTS AND MAIN RESULTS


Sedation with dexmedetomidine as the primary sedative resulted in a greater proportion of sedation measurements in the light sedation range (State Behavioral Scale -1 to +1) over the first 48 hours (229/325 [71%] vs 181/331 [58%]; p = 0.04) and the first 24 hours (66/103 [64%] vs 48/116 [41%]; p < 0.001) compared with usual care. Cumulative midazolam dosage was significantly reduced in the dexmedetomidine arm compared with usual care (p = 0.002).There were more episodes of hypotension and bradycardia with dexmedetomidine (including one serious adverse event) but no difference in vasopressor requirements. Median time to randomization after intubation was 6.0 hours (interquartile range, 2.0-9.0 hr) in the dexmedetomidine arm compared with 3.0 hours (interquartile range, 1.0-7.0 hr) in the usual care arm (p = 0.24).
CONCLUSIONS


A sedation protocol using dexmedetomidine as the primary sedative was feasible, appeared safe, achieved early, light sedation, and reduced midazolam requirements. The findings of this pilot study justify further studies of sedative agents in critically ill children.",2020,Cumulative midazolam dosage was significantly reduced in the dexmedetomidine arm compared with usual care (p = 0.002).There were more episodes of hypotension and bradycardia with dexmedetomidine (including one serious adverse event) but no difference in vasopressor requirements.,"['Critically ill children, younger than 16 years old, requiring intubation and mechanical ventilation and expected to be mechanically ventilated for at least 24 hours', 'Mechanically Ventilated Critically Ill Children', 'critically ill children', 'Six tertiary PICUs in Australia and New Zealand', 'mechanically ventilated critically ill children']","['dexmedetomidine-based algorithm targeted to light sedation (State Behavioral Scale -1 to +1', 'Dexmedetomidine Sedation', 'dexmedetomidine', 'usual care received sedation as determined by the treating clinician (but not dexmedetomidine']","['hypotension and bradycardia', 'proportion of sedation scores', 'feasibility, safety, and efficacy', 'proportion of sedation measurements', 'light sedation range (State Behavioral Scale -1 to +1', 'time to randomization and protocol fidelity', 'device removal, adverse events, and vasopressor use', 'Cumulative midazolam dosage', 'Median time to randomization after intubation']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0752250', 'cui_str': 'Removal of device'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]",,0.154635,Cumulative midazolam dosage was significantly reduced in the dexmedetomidine arm compared with usual care (p = 0.002).There were more episodes of hypotension and bradycardia with dexmedetomidine (including one serious adverse event) but no difference in vasopressor requirements.,"[{'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Erickson', 'Affiliation': ""1Paediatric Critical Care, Perth Children's Hospital, Perth, WA, Australia. 2Paediatric Intensive Care Unit, Royal Children's Hospital, Melbourne, VIC, Australia. 3Murdoch Children's Research Institute, University of Melbourne, Melbourne, VIC, Australia. 4Paediatric Intensive Care Unit, Starship Children's Hospital, Auckland, New Zealand. 5Department of Anaesthesiology, University of Auckland, Auckland, New Zealand. 6Kids Critical Care Research, The Children's Hospital at Westmead, Westmead, NSW, Australia. 7Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia. 8School of Clinical Sciences, Monash University, Melbourne, VIC, Australia. 9Clinical School of Medicine, University of New South Wales, Sydney, NSW, Australia. 10Paediatric Intensive Care Unit, Queensland Children's Hospital, Brisbane, QLD, Australia. 11Children's Health Research Centre, The University of Queensland, Brisbane, QLD, Australia.""}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Millar', 'Affiliation': ''}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'Marino S', 'Initials': 'MS', 'LastName': 'Festa', 'Affiliation': ''}, {'ForeName': 'Lahn', 'Initials': 'L', 'LastName': 'Straney', 'Affiliation': ''}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Shehabi', 'Affiliation': ''}, {'ForeName': 'Debbie A', 'Initials': 'DA', 'LastName': 'Long', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002483']
1681,32740218,Direct oral anticoagulants in chronic kidney disease: an update.,"PURPOSE OF REVIEW


Direct oral anticoagulants (DOACs) are variably eliminated by the kidneys rendering their use potentially problematic in patients with chronic kidney disease (CKD) or necessitating appropriate dose adjustment.
RECENT FINDINGS


Both observational and limited randomized trial data for DOACs compared with no treatment or with warfarin for patients with atrial fibrillation on maintenance dialysis were recently published. In a randomized trial in patients on hemodialysis, there was no significant difference in vascular calcification between patients who received rivaroxaban with or without vitamin K2 or vitamin K antagonists. A randomized trial of apixaban versus warfarin was terminated owing to poor enrollment and preliminary results identified no difference in clinical outcomes between groups. However, valuable pharmacodynamic data will be forthcoming from that trial. In observational research, among patients newly diagnosed with atrial fibrillation, there were opposing trends in the associations of apixaban initiation versus no oral anticoagulation with ischemic versus hemorrhagic stroke and no association was present with the overall risk of stroke or embolism. In another study comparing apixaban with warfarin initiation, apixaban was associated with less bleeding. Regular-dose apixaban (5 mg twice daily) associated with reduced rates of ischemic stroke or systemic embolism, whereas no such association was present for those prescribed the reduced dose (2.5 mg twice daily).
SUMMARY


DOACs may be used after appropriate dose adjustment for an established clinical indication in patients with advanced CKD. Quality evidence for oral anticoagulation, with any specific agent or dose, for stroke prevention in hemodialysis continues to be lacking.",2020,"Regular-dose apixaban (5 mg twice daily) associated with reduced rates of ischemic stroke or systemic embolism, whereas no such association was present for those prescribed the reduced dose (2.5 mg twice daily).
","['patients newly diagnosed with atrial fibrillation', 'patients with atrial fibrillation on maintenance dialysis', 'chronic kidney disease', 'patients with chronic kidney disease (CKD) or necessitating appropriate dose adjustment', 'patients with advanced CKD']","['apixaban with warfarin initiation, apixaban', 'apixaban versus warfarin', 'Regular-dose apixaban', 'warfarin', 'rivaroxaban', 'vitamin K2 or vitamin K antagonists', 'Direct oral anticoagulants']","['vascular calcification', 'bleeding', 'overall risk of stroke or embolism', 'rates of ischemic stroke or systemic embolism']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0342649', 'cui_str': 'Vascular calcification'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]",,0.0523301,"Regular-dose apixaban (5 mg twice daily) associated with reduced rates of ischemic stroke or systemic embolism, whereas no such association was present for those prescribed the reduced dose (2.5 mg twice daily).
","[{'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Mavrakanas', 'Affiliation': 'Department of Medicine, McGill University, Montreal, QC & Department of Medicine, Geneva University Hospitals & Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Charytan', 'Affiliation': 'Division of Nephrology, NYU Grossman School of Medicine, New York, New York.'}, {'ForeName': 'Wolfgang C', 'Initials': 'WC', 'LastName': 'Winkelmayer', 'Affiliation': 'Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston, Texas, USA.'}]",Current opinion in nephrology and hypertension,['10.1097/MNH.0000000000000634']
1682,32738955,"Cytosponge-trefoil factor 3 versus usual care to identify Barrett's oesophagus in a primary care setting: a multicentre, pragmatic, randomised controlled trial.","BACKGROUND


Treatment of dysplastic Barrett's oesophagus prevents progression to adenocarcinoma; however, the optimal diagnostic strategy for Barrett's oesophagus is unclear. The Cytosponge-trefoil factor 3 (TFF3) is a non-endoscopic test for Barrett's oesophagus. The aim of this study was to investigate whether offering this test to patients on medication for gastro-oesophageal reflux would increase the detection of Barrett's oesophagus compared with standard management.
METHODS


This multicentre, pragmatic, randomised controlled trial was done in 109 socio-demographically diverse general practice clinics in England. Randomisation was done both at the general practice clinic level (cluster randomisation) and at the individual patient level, and the results for each type of randomisation were analysed separately before being combined. Patients were eligible if they were aged 50 years or older, had been taking acid-suppressants for symptoms of gastro-oesophageal reflux for more than 6 months, and had not undergone an endoscopy procedure within the past 5 years. General practice clinics were selected by the local clinical research network and invited to participate in the trial. For cluster randomisation, clinics were randomly assigned (1:1) by the trial statistician using a computer-generated randomisation sequence; for individual patient-level randomisation, patients were randomly assigned (1:1) by the general practice clinics using a centrally prepared computer-generated randomisation sequence. After randomisation, participants received either standard management of gastro-oesophageal reflux (usual care group), in which participants only received an endoscopy if required by their general practitioner, or usual care plus an offer of the Cytosponge-TFF3 procedure, with a subsequent endoscopy if the procedure identified TFF3-positive cells (intervention group). The primary outcome was the diagnosis of Barrett's oesophagus at 12 months after enrolment, expressed as a rate per 1000 person-years, in all participants in the intervention group (regardless of whether they had accepted the offer of the Cytosponge-TFF3 procedure) compared with all participants in the usual care group. Analyses were intention-to-treat. The trial is registered with the ISRCTN registry, ISRCTN68382401, and is completed.
FINDINGS


Between March 20, 2017, and March 21, 2019, 113 general practice clinics were enrolled, but four clinics dropped out shortly after randomisation. Using an automated search of the electronic prescribing records of the remaining 109 clinics, we identified 13 657 eligible patients who were sent an introductory letter with 14 days to opt out. 13 514 of these patients were randomly assigned (per practice or at the individual patient level) to the usual care group (n=6531) or the intervention group (n=6983). Following randomisation, 149 (2%) of 6983 participants in the intervention group and 143 (2%) of 6531 participants in the usual care group, on further scrutiny, did not meet all eligibility criteria or withdrew from the study. Of the remaining 6834 participants in the intervention group, 2679 (39%) expressed an interest in undergoing the Cytosponge-TFF3 procedure. Of these, 1750 (65%) met all of the eligibility criteria on telephone screening and underwent the procedure. Most of these participants (1654 [95%]; median age 69 years) swallowed the Cytosponge successfully and produced a sample. 231 (3%) of 6834 participants had a positive Cytosponge-TFF3 result and were referred for an endoscopy. Patients who declined the offer of the Cytosponge-TFF3 procedure and all participants in the usual care group only had an endoscopy if deemed necessary by their general practitioner. During an average of 12 months of follow-up, 140 (2%) of 6834 participants in the intervention group and 13 (<1%) of 6388 participants in the usual care group were diagnosed with Barrett's oesophagus (absolute difference 18·3 per 1000 person-years [95% CI 14·8-21·8]; rate ratio adjusted for cluster randomisation 10·6 [95% CI 6·0-18·8], p<0·0001). Nine (<1%) of 6834 participants were diagnosed with dysplastic Barrett's oesophagus (n=4) or stage I oesophago-gastric cancer (n=5) in the intervention group, whereas no participants were diagnosed with dysplastic Barrett's oesophagus or stage I gastro-oesophageal junction cancer in the usual care group. Among 1654 participants in the intervention group who swallowed the Cytosponge device successfully, 221 (13%) underwent endoscopy after testing positive for TFF3 and 131 (8%, corresponding to 59% of those having an endoscopy) were diagnosed with Barrett's oesophagus or cancer. One patient had a detachment of the Cytosponge from the thread requiring endoscopic removal, and the most common side-effect was a sore throat in 63 (4%) of 1654 participants.
INTERPRETATION


In patients with gastro-oesophageal reflux, the offer of Cytosponge-TFF3 testing results in improved detection of Barrett's oesophagus. Cytosponge-TFF3 testing could also lead to the diagnosis of treatable dysplasia and early cancer. This strategy will lead to additional endoscopies with some false positive results.
FUNDING


Cancer Research UK, National Institute for Health Research, the UK National Health Service, Medtronic, and the Medical Research Council.",2020,The Cytosponge-trefoil factor 3 (TFF3) is a non-endoscopic test for Barrett's oesophagus.,"['Patients were eligible if they were aged 50 years or older, had been taking acid-suppressants for symptoms of gastro-oesophageal reflux for more than 6 months, and had not undergone an endoscopy procedure within the past 5 years', 'Patients who declined the offer of the Cytosponge-TFF3 procedure and all participants in the usual care group only had an endoscopy if deemed necessary by their general practitioner', 'remaining 109 clinics, we identified 13\u2008657 eligible patients who were sent an introductory letter with 14 days to opt out', '6983 participants in the intervention group and 143 (2%) of 6531 participants in the usual care group, on further scrutiny, did not meet all eligibility criteria or withdrew from the study', 'Between March 20, 2017, and March 21, 2019, 113 general practice clinics were enrolled, but four clinics dropped out shortly after randomisation', ""1654 participants in the intervention group who swallowed the Cytosponge device successfully, 221 (13%) underwent endoscopy after testing positive for TFF3 and 131 (8%, corresponding to 59% of those having an endoscopy) were diagnosed with Barrett's oesophagus or cancer"", ""6834 participants were diagnosed with dysplastic Barrett's oesophagus (n=4) or stage"", '231 (3%) of 6834 participants had a positive Cytosponge-TFF3 result and were referred for an endoscopy', '109 socio-demographically diverse general practice clinics in England', 'patients with gastro-oesophageal reflux']","[""Cytosponge-trefoil factor 3 versus usual care to identify Barrett's oesophagus"", 'standard management of gastro-oesophageal reflux (usual care group), in which participants only received an endoscopy if required by their general practitioner, or usual care plus an offer of the Cytosponge-TFF3 procedure, with a subsequent endoscopy if the procedure identified TFF3-positive cells (intervention group']","[""diagnosis of Barrett's oesophagus"", ""diagnosed with dysplastic Barrett's oesophagus or stage I gastro-oesophageal junction cancer"", ""diagnosed with Barrett's oesophagus""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0660409', 'cui_str': 'TFF3 protein, human'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004763', 'cui_str': ""Barrett's esophagus""}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0660409', 'cui_str': 'TFF3 protein, human'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0004763', 'cui_str': ""Barrett's esophagus""}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004763', 'cui_str': ""Barrett's esophagus""}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",6834.0,0.132661,The Cytosponge-trefoil factor 3 (TFF3) is a non-endoscopic test for Barrett's oesophagus.,"[{'ForeName': 'Rebecca C', 'Initials': 'RC', 'LastName': 'Fitzgerald', 'Affiliation': 'MRC Cancer Unit, Hutchison-MRC Research Centre, University of Cambridge, Cambridge, UK; Cambridge University Hospitals National Health Service Foundation Trust, Cambridge, UK. Electronic address: rcf29@mrc-cu.cam.ac.uk.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'di Pietro', 'Affiliation': 'MRC Cancer Unit, Hutchison-MRC Research Centre, University of Cambridge, Cambridge, UK; Cambridge University Hospitals National Health Service Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': ""O'Donovan"", 'Affiliation': 'MRC Cancer Unit, Hutchison-MRC Research Centre, University of Cambridge, Cambridge, UK; Cambridge University Hospitals National Health Service Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Maroni', 'Affiliation': ""Cancer Research UK and King's College London Cancer Prevention Trials Unit, School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.""}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Muldrew', 'Affiliation': ""Cancer Research UK and King's College London Cancer Prevention Trials Unit, School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.""}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Debiram-Beecham', 'Affiliation': 'MRC Cancer Unit, Hutchison-MRC Research Centre, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Gehrung', 'Affiliation': 'Cancer Research UK Cambridge Institute, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Offman', 'Affiliation': ""Cancer Prevention Group, School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.""}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Tripathi', 'Affiliation': 'MRC Cancer Unit, Hutchison-MRC Research Centre, University of Cambridge, Cambridge, UK; Cambridge University Hospitals National Health Service Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Samuel G', 'Initials': 'SG', 'LastName': 'Smith', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Aigret', 'Affiliation': ""Cancer Research UK and King's College London Cancer Prevention Trials Unit, School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.""}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Walter', 'Affiliation': 'The Primary Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Rubin', 'Affiliation': 'Institute of Population Health Sciences, Newcastle University, Sir James Spence Institute, Royal Victoria Infirmary, Newcastle upon Tyne, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sasieni', 'Affiliation': ""Cancer Research UK and King's College London Cancer Prevention Trials Unit, School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.""}]","Lancet (London, England)",['10.1016/S0140-6736(20)31099-0']
1683,32744951,Exploring the effects of visual and literary arts interventions on psychosocial well-being of diverse older adults: a mixed methods pilot study.,"BACKGROUND


Engagement in the arts may have health benefits for older adults. Most research has focused on music and dance; less is known about the benefits of other arts interventions. The purpose of this study was to examine the effects of visual (ceramics and collage) and literary arts (storytelling and writing) on well-being.
METHODS


We used mixed methods to examine the effects of a 12-week visual or literary arts intervention on well-being. Adults age 55 and over from four housing sites were assigned to start an intervention immediately (intervention) or wait 12 weeks (controls). The study included pre/post-test measures of well-being and focus groups about perceived benefits.
RESULTS


Compared to controls, participants in the ceramics intervention had significant improvements in interest in life and mastery, while no changes were observed after the storytelling intervention. Seven psychosocial benefits were identified .
CONCLUSIONS


Participation in visual and literary arts for older adults was associated with well-being media.",2020,"Compared to controls, participants in the ceramics intervention had significant improvements in interest in life and mastery, while no changes were observed after the storytelling intervention.","['diverse older adults', 'Adults age 55 and over from four housing sites', 'older adults']","['visual and literary arts interventions', 'visual or literary arts intervention', 'visual (ceramics and collage) and literary arts (storytelling and writing']",['life and mastery'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}]",7.0,0.0467071,"Compared to controls, participants in the ceramics intervention had significant improvements in interest in life and mastery, while no changes were observed after the storytelling intervention.","[{'ForeName': 'Julene K', 'Initials': 'JK', 'LastName': 'Johnson', 'Affiliation': 'Institute for Health & Aging, University of California , San Francisco, CA, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Carpenter', 'Affiliation': 'EngAGE, Inc ., Los Angeles, CA, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Goodhart', 'Affiliation': 'EngAGE, Inc ., Los Angeles, CA, USA.'}, {'ForeName': 'Anita L', 'Initials': 'AL', 'LastName': 'Stewart', 'Affiliation': 'Institute for Health & Aging, University of California , San Francisco, CA, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'du Plessis', 'Affiliation': 'Institute for Health & Aging, University of California , San Francisco, CA, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Coaston', 'Affiliation': 'School of Nursing, University of California , San Francisco, CA, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Clark', 'Affiliation': 'School of Nursing, University of California , San Francisco, CA, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Lazar', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California , San Francisco, CA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Chapline', 'Affiliation': 'New Art Horizons , Pacifica, CA, USA.'}]",Arts & health,['10.1080/17533015.2020.1802603']
1684,32754748,"Cost-Effectiveness and Efficacy of a Novel Combination Regimen in Acromegaly: A Prospective, Randomized Trial.","CONTEXT


Combination therapy with somatostatin receptor ligand (SRL) plus pegvisomant for patients with acromegaly is recommended after a maximizing dose on monotherapy. Lower-dose combination regimens are not well studied.
OBJECTIVE


To compare cost-effectiveness and efficacy of 3 lower-dose combination regimens in controlled and uncontrolled acromegaly.
DESIGN AND SETTING


Prospective, randomized, open-label, parallel arm study at a tertiary referral pituitary center.
PATIENTS


Adults with acromegaly regardless of response to prior SRL and biochemical control status at baseline, stratified by an SRL dose required for insulin-like growth factor (IGF)-I normalization during any 3-month period within 12 months preceding enrollment.
INTERVENTION


Combination therapy for 24 to 32 weeks on arm A, high-dose SRL (lanreotide 120 mg/octreotide long-acting release [LAR] 30 mg) plus weekly pegvisomant (40-160 mg/week); arm B, low-dose SRL (lanreotide 60 mg/octreotide LAR 10 mg) plus weekly pegvisomant; or arm C, low-dose SRL plus daily pegvisomant (15-60 mg/day).
MAIN OUTCOME MEASURE


Monthly treatment cost in each arm in participants completing ≥ 24 weeks of therapy.
RESULTS


Sixty patients were enrolled and 52 were evaluable. Fifty of 52 (96%) demonstrated IGF-I control regardless of prior SRL responsiveness (arm A, 14/15 [93.3%]; arm B, 22/23 [95.7%]; arm C, 14/14 [100%]). Arm B was least costly (mean, $9837 ± 1375 per month), arm C was most expensive (mean, $22543 ± 11158 per month), and arm A had an intermediate cost (mean, $14261 ± 1645 per month). Approximately 30% of patients required pegvisomant dose uptitration. Rates of adverse events were all < 10%.
CONCLUSIONS


Low-dose SRL plus weekly pegvisomant represents a novel dosing option for achieving cost-effective, optimal biochemical control in patients with uncontrolled acromegaly requiring combination therapy.",2020,"Arm B was least costly (mean, $9,837±1,375 per month); Arm C was most expensive (mean, $22,543±11,158 per month) and Arm A had an intermediate cost (mean, $14,261±1,645 per month).","['tertiary referral pituitary center', 'patients with uncontrolled acromegaly requiring combination therapy', 'Sixty patients were enrolled and 52 evaluable', 'Adults with acromegaly regardless of response to prior SRL and biochemical control status at baseline, stratified by SRL dose required for IGF-I normalization during any 3-month period within 12 months preceding enrollment']","['SRL (lanreotide 120 mg/octreotide LAR 30 mg) plus weekly pegvisomant', 'SRL (lanreotide 60 mg/octreotide LAR 10 mg) plus weekly pegvisomant; or Arm C, low-dose SRL plus daily pegvisomant', 'somatostatin receptor ligand (SRL) plus pegvisomant', 'novel combination regimen']","['cost-effectiveness and efficacy', 'Rates of adverse events', 'Cost-effectiveness and efficacy', 'IGF-I control regardless of prior SRL responsiveness']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0001206', 'cui_str': 'Acromegaly'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0074830', 'cui_str': 'Somatostatin Receptor'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C0074830', 'cui_str': 'Somatostatin Receptor'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0209211', 'cui_str': 'lanreotide'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0028833', 'cui_str': 'Octreotide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0913469', 'cui_str': 'pegvisomant'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0074830', 'cui_str': 'Somatostatin Receptor'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}]",60.0,0.043846,"Arm B was least costly (mean, $9,837±1,375 per month); Arm C was most expensive (mean, $22,543±11,158 per month) and Arm A had an intermediate cost (mean, $14,261±1,645 per month).","[{'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Bonert', 'Affiliation': 'Pituitary Center, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Mirocha', 'Affiliation': 'Biostatistics and Bioinformatics Research Center, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Carmichael', 'Affiliation': 'Division of Endocrinology and Metabolism, Keck School of Medicine, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Kevin C J', 'Initials': 'KCJ', 'LastName': 'Yuen', 'Affiliation': 'Department of Neuroendocrinology and Neurosurgery, Barrow Neurological Institute, University of Arizona College of Medicine and Creighton School of Medicine, Phoenix, Arizona.'}, {'ForeName': 'Takako', 'Initials': 'T', 'LastName': 'Araki', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Shlomo', 'Initials': 'S', 'LastName': 'Melmed', 'Affiliation': 'Pituitary Center, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa444']
1685,32750332,The effect of oxytocin on pupil response to naturalistic dynamic facial expressions.,"The neuropeptide oxytocin (OT) has been found to play an important role in a variety of social behaviours and social cognition in particular. The social salience hypothesis of OT suggests that OT shifts attention towards socially relevant stimuli, which offers an explanation for improvements on social cognition measures following OT administration. Pupil dilation occurs with increasing attentional resource allocation and previous research has found that OT administration led to an increase in pupil diameter in response to social stimuli relative to placebo (PL), thereby suggesting increased social attention. The current study aimed to investigate the effects of OT on pupillary responses to more naturalistic social stimuli in a larger sample. Ninety-four male participants took part in the double-blind, placebo controlled, mixed-design study, in which they self-administered either an OT or PL nasal spray before viewing naturalistic dynamic facial expressions of emotion (happy, sad, fear and anger). Contrary to prediction, there was no effect of OT administration on pupil diameter. The results are discussed in light of the social salience hypothesis and with reference to the methodological differences between studies.",2020,"Pupil dilation occurs with increasing attentional resource allocation and previous research has found that OT administration led to an increase in pupil diameter in response to social stimuli relative to placebo (PL), thereby suggesting increased social attention.",['Ninety-four male participants took part in the double-blind'],"['OT', 'oxytocin', 'OT or PL nasal spray', 'neuropeptide oxytocin (OT', 'placebo']","['social cognition measures', 'pupil response to naturalistic dynamic facial expressions', 'emotion (happy, sad, fear and anger']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}]",94.0,0.0408089,"Pupil dilation occurs with increasing attentional resource allocation and previous research has found that OT administration led to an increase in pupil diameter in response to social stimuli relative to placebo (PL), thereby suggesting increased social attention.","[{'ForeName': 'Daniel T', 'Initials': 'DT', 'LastName': 'Burley', 'Affiliation': 'Cardiff University Centre for Human Developmental Science, School of Psychology, Cardiff University, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Daughters', 'Affiliation': 'Neuroscience and Mental Health Research Institute, Cardiff University, United Kingdom of Great Britain and Northern Ireland. Electronic address: k.daughters@essex.ac.uk.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104837']
1686,32750572,Clinical outcomes from the texting for relapse prevention (T4RP) in schizophrenia and schizoaffective disorder study.,"This 6 month randomized control trial investigated whether a novel text-messaging program impacted targeted clinical outcomes in patients with schizophrenia and schizoaffective disorder (SAD). Forty patients were enrolled and completed baseline, 3-month and 6-month assessments. The intervention group received daily symptom check-in text messages, plus, a medication reminder or, inspirational quote text. The control group had treatment as usual. At 6 months the Positive and Negative Syndrome Scale mean positive score was significantly lower and injectable medication compliance was significantly higher in the intervention group. Recovery scores were significantly higher at 3 months. Results suggest that this program may benefit individuals with schizophrenia/SAD who use text messaging. Further investigation in a larger sample appears warranted.",2020,At 6 months the Positive and Negative Syndrome Scale mean positive score was significantly lower and injectable medication compliance was significantly higher in the intervention group.,"['patients with schizophrenia and schizoaffective disorder (SAD', 'Forty patients were enrolled and completed baseline, 3-month and 6-month assessments']","['texting for relapse prevention (T4RP', 'daily symptom check-in text messages, plus, a medication reminder or, inspirational quote text', 'novel text-messaging program']","['Recovery scores', 'injectable medication compliance', 'Positive and Negative Syndrome Scale mean positive score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",40.0,0.0323144,At 6 months the Positive and Negative Syndrome Scale mean positive score was significantly lower and injectable medication compliance was significantly higher in the intervention group.,"[{'ForeName': 'Bernadette A', 'Initials': 'BA', 'LastName': 'Cullen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The Johns Hopkins Medical Institutions, Baltimore, Maryland, USA; Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA. Electronic address: bcullen@jhmi.edu.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Eaton', 'Affiliation': 'Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Mojtabai', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The Johns Hopkins Medical Institutions, Baltimore, Maryland, USA; Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Von Mach', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, USA.""}, {'ForeName': 'Michele L', 'Initials': 'ML', 'LastName': 'Ybarra', 'Affiliation': 'Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Center for Innovative Public Health Research, San Clemente, California, USA.'}]",Psychiatry research,['10.1016/j.psychres.2020.113346']
1687,32750626,Association of patient preferences on medication discussion in hypertension: Results from a randomized clinical trial.,"Patient-centered care has received significant attention and is an integral component of high-quality healthcare. While it is often assumed that most prefer a patient-centered role orientation, such preferences exist along a continuum with some patients preferring a more provider-centered role. The present study examines patient preference data from a randomized clinical trial designed to test the efficacy of a patient activation intervention to promote thiazide prescribing for veteran patients with uncontrolled hypertension. Patient preferences for involvement in healthcare were assessed using the 9-item Sharing subscale of the Patient-Practitioner Orientation Scale (PPOS). The primary aim was to examine differences in discussion of thiazide use in the clinical encounter by those scoring high versus low on the PPOS. Five hundred ninety-five veteran patients were randomized to either one of three intervention groups or a usual care control group. The adjusted odds ratios (OR) for the three intervention groups relative to the control group indicated that thiazide discussion increased as a function of intervention intensity across both high and low PPOS groups. ORs for the most intensive intervention group were 3.72 (95% CI = 1.61-8.65, p < .01) for high PPOS patients and 6.71 (95% CI = 2.59-10.67, p < .001) for low PPOS patients. Results suggest that this patient activation intervention is effective for veteran patients representing a range of preferred involvement. Consideration of such preferences may be useful in tailoring future interventions in the healthcare context.",2020,"ORs for the most intensive intervention group were 3.72 (95% CI = 1.61-8.65, p < .01) for high PPOS patients and 6.71 (95% CI = 2.59-10.67, p < .001) for low PPOS patients.","['Five hundred ninety-five veteran patients', 'veteran patients with uncontrolled hypertension', 'hypertension']","['patient activation intervention', 'thiazide prescribing', 'thiazide', 'activation intervention', 'usual care control group']","['9-item Sharing subscale of the Patient-Practitioner Orientation Scale (PPOS', 'adjusted odds ratios (OR', 'function of intervention intensity']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012802', 'cui_str': 'Thiazide diuretic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",595.0,0.0335965,"ORs for the most intensive intervention group were 3.72 (95% CI = 1.61-8.65, p < .01) for high PPOS patients and 6.71 (95% CI = 2.59-10.67, p < .001) for low PPOS patients.","[{'ForeName': 'M Bryant', 'Initials': 'MB', 'LastName': 'Howren', 'Affiliation': 'Center for Access Delivery Research & Evaluation (CADRE), VA Iowa City Healthcare System, Iowa City, IA, USA; Department of Behavioral Sciences & Social Medicine, College of Medicine, Florida State University, Tallahassee, FL, USA. Electronic address: matthew.howren@med.fsu.edu.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Vander Weg', 'Affiliation': 'Center for Access Delivery Research & Evaluation (CADRE), VA Iowa City Healthcare System, Iowa City, IA, USA; Division of General Internal Medicine, The University of Iowa Carver College of Medicine, Iowa City, IA, USA; Department of Psychological & Brain Sciences, The University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Christensen', 'Affiliation': 'Department of Psychology, East Carolina University, Greenville, NC, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kaboli', 'Affiliation': 'Center for Access Delivery Research & Evaluation (CADRE), VA Iowa City Healthcare System, Iowa City, IA, USA; Division of General Internal Medicine, The University of Iowa Carver College of Medicine, Iowa City, IA, USA.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113244']
1688,32763073,Impact of Repositioning on Outcomes Following Transcatheter Aortic Valve Replacement With a Self-Expandable Valve.,"OBJECTIVES


This study sought to compare outcomes following transcatheter aortic valve replacement when valve repositioning was performed (repositioned group) versus procedures without repositioning (nonrepositioned group).
BACKGROUND


The Evolut R and Evolut PRO valves were designed to allow repositioning during deployment, yet the effect of repositioning on clinical outcomes remains unclear.
METHODS


Patients implanted with the Evolut R or PRO valve from the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial continued access study and the Evolut Low Risk Trial between June 2016 and November 2018 were combined. Baseline multidetector computed tomography data were analyzed for the Evolut Low Risk Trial patients. The primary outcomes were the rate of all-cause mortality and the rate of disabling stroke 30 days. Secondary outcomes were per Valve Academic Research Consortium-2.
RESULTS


The Evolut R or PRO valve was implanted in 946 patients, and repositioning was performed in 318 (33.6%). Compared with patients in the nonrepositioned group, patients in the repositioned group had lower Society of Thoracic Surgeons score (2.3 ± 1.3% vs. 2.6 ± 1.4%; p < 0.001) and fewer prior percutaneous coronary interventions (11.9% vs. 19.7%; p = 0.003). There were no differences in baseline multidetector computed tomography parameters between groups. There were no differences in the primary outcome of death (0.3% vs. 0.3%; p = 0.99) or disabling stroke (0.3% vs. 0.5%; p = 0.71) at 30 days or 1 year (1.9% vs. 2.9%; p = 0.44; and 0.8% vs. 0.9%%; p = 0.79, respectively).
CONCLUSIONS


The utilization of the repositioning feature of the Evolut valves was safe, and no differences in death or disabling stroke were observed at 30 days or 1 year between groups. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283; Safety and Efficacy Study of the Medtronic CoreValve® System In the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement [SURTAVI]; NCT01586910).",2020,"The utilization of the repositioning feature of the Evolut valves was safe, and no differences in death or disabling stroke were observed at 30 days or 1 year between groups.","['Patients implanted with the Evolut R or PRO valve from the SURTAVI ', 'Intermediate Risk Subjects']","['transcatheter aortic valve replacement', 'Need Aortic Valve Replacement', 'Replacement With a Self-Expandable Valve', 'Transcatheter Aortic Valve', 'Medtronic CoreValve® System', 'Surgical Replacement and Transcatheter Aortic Valve Implantation', 'procedures without repositioning (nonrepositioned group']","['fewer prior percutaneous coronary interventions', 'death', 'rate of all-cause mortality and the rate of disabling stroke 30\xa0days', 'baseline multidetector computed tomography parameters', 'per Valve Academic Research Consortium-2', 'disabling stroke', 'death or disabling stroke', 'Evolut R or PRO valve', 'lower Society of Thoracic Surgeons score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0003501', 'cui_str': 'Aortic valve structure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3179130', 'cui_str': 'Multidetector-Row Computed Tomography'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0278626', 'cui_str': 'Thoracic surgeon'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",946.0,0.112353,"The utilization of the repositioning feature of the Evolut valves was safe, and no differences in death or disabling stroke were observed at 30 days or 1 year between groups.","[{'ForeName': 'Guilherme F', 'Initials': 'GF', 'LastName': 'Attizzani', 'Affiliation': 'Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, Ohio. Electronic address: guilherme.attizzani@uhhospitals.org.'}, {'ForeName': 'Luis Augusto P', 'Initials': 'LAP', 'LastName': 'Dallan', 'Affiliation': 'Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Markowitz', 'Affiliation': 'Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Yakubov', 'Affiliation': 'Department of Interventional Cardiology, OhioHealth Riverside Methodist, Columbus, Ohio.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Deeb', 'Affiliation': 'Departments of Cardiac Surgery, University of Michigan Hospitals, Ann Arbor, Michigan.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Reardon', 'Affiliation': 'Department of Cardiothoracic Surgery, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Forrest', 'Affiliation': 'Departments of Internal Medicine (Cardiology) and Cardiac Surgery, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Abeel A', 'Initials': 'AA', 'LastName': 'Mangi', 'Affiliation': 'Departments of Internal Medicine (Cardiology) and Cardiac Surgery, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Biostatistics, Medtronic Statistical Services, Minneapolis, Minnesota.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Popma', 'Affiliation': 'Department of Interventional Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.04.028']
1689,32763086,Randomised controlled trial of pharmacist-led patient counselling in controlling hypoglycaemic attacks in older adults with type 2 diabetes mellitus (ROSE-ADAM): A study protocol of the SUGAR intervention.,"INTRODUCTION


Hypoglycaemia is one of the most serious adverse effects of diabetes treatment. Older adults are at the highest risk to develop hypoglycaemia. Several studies have established the important positive role of educational interventions on achieving glycaemic control and other clinical outcomes, however, there is still a lack in studies that evaluate the impact of such type of interventions on hypoglycaemia risk in elderly patients with type 2 diabetes. The purpose of this research is to evaluate the effectiveness of pharmacist-led patient counselling on reducing hypoglycaemic attacks in older adults with type 2 diabetes mellitus.
METHODS


and analysis: This study is an open-label, parallel controlled randomised trial, which will be conducted in the outpatient clinics at the largest referral hospital in the north of Jordan. Participants who are elderly (age ≥ 65 years), diagnosed with type 2 diabetes mellitus, and taking insulin, sulfonylurea, or any three anti-diabetic medications will be randomly assigned to intervention (SUGAR Handshake) and control (usual care) groups. The SUGAR Handshake participants will have an interactive, individualised, medications-focused counselling session reinforced with a pictogram and a phone call at week six of enrolment. The primary outcome measure is the frequency of total hypoglycaemic events within 12 weeks of follow up. Secondary outcomes include the frequency of asymptomatic, symptomatic, and severe hypoglycaemic events, hypoglycaemia incidence, and time to the first hypoglycaemic attack. We will also conduct a nested qualitative study for process evaluation.
ETHICS AND DISSEMINATION


The Human Research Ethics Committee of the University of Lincoln and the Institutional Review Board of King Abdullah University Hospital approved this protocol. The findings of this study will be presented in international conferences and published in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


The study protocol has been registered with ClinicalTrials.gov, NCT04081766.",2020,"The purpose of this research is to evaluate the effectiveness of pharmacist-led patient counselling on reducing hypoglycaemic attacks in older adults with type 2 diabetes mellitus.
","['elderly patients with type 2 diabetes', 'older adults with type 2 diabetes mellitus', 'Older adults', 'outpatient clinics at the largest referral hospital in the north of Jordan', 'older adults with type 2 diabetes mellitus (ROSE-ADAM', 'Participants who are elderly (age\xa0≥\xa065 years), diagnosed with type 2 diabetes mellitus, and taking insulin, sulfonylurea, or any three anti-diabetic medications']","['SUGAR intervention', 'pharmacist-led patient counselling']","['frequency of total hypoglycaemic events', 'frequency of asymptomatic, symptomatic, and severe hypoglycaemic events, hypoglycaemia incidence, and time to the first hypoglycaemic attack', 'hypoglycaemic attacks', 'hypoglycaemia risk', 'Hypoglycaemia']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C1529905', 'cui_str': '(123I)ADAM'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0600047', 'cui_str': 'Patient counseled'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycaemic episode'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.12039,"The purpose of this research is to evaluate the effectiveness of pharmacist-led patient counselling on reducing hypoglycaemic attacks in older adults with type 2 diabetes mellitus.
","[{'ForeName': 'Huda Y', 'Initials': 'HY', 'LastName': 'Almomani', 'Affiliation': 'School of Pharmacy, University of Lincoln, LN6 7DL, Lincoln, UK. Electronic address: huda.almomani@yahoo.com.'}, {'ForeName': 'Carlos Rodriguez', 'Initials': 'CR', 'LastName': 'Pascual', 'Affiliation': 'School of Pharmacy, University of Lincoln, LN6 7DL, Lincoln, UK.'}, {'ForeName': 'Sayer I', 'Initials': 'SI', 'LastName': 'Al-Azzam', 'Affiliation': 'Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, 22110, Jordan.'}, {'ForeName': 'Keivan', 'Initials': 'K', 'LastName': 'Ahmadi', 'Affiliation': 'Lincoln Medical School, Universities of Nottingham and Lincoln, University of Lincoln, LN6 7TS, Lincoln, UK.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2020.07.012']
1690,32763640,Implementing an intensive care unit (ICU) diary program at a large academic medical center: Results from a randomized control trial evaluating psychological morbidity associated with critical illness.,"BACKGROUND


Psychological morbidity in both patients and family members related to the intensive care unit (ICU) experience is an often overlooked, and potentially persistent, healthcare problem recognized by the Society of Critical Care Medicine as Post-intensive Care Syndrome (PICS). ICU diaries are an intervention increasingly under study with potential to mitigate ICU-related psychological morbidity, including ICU-related post-traumatic stress disorder (PTSD), depression and anxiety. As we encounter a growing number of ICU survivors, in particular in the wake of the coronavirus pandemic, clinicians must be equipped to understand the severity and prevalence of significant psychiatric complications of critical illness.
METHODS


We compared the efficacy of the ICU diary, written by family and healthcare workers during the patient's intensive care course, versus education alone in reducing acute PTSD symptoms after discharge. Patients with an ICU stay >72 h, who were intubated and mechanically ventilated over 24 h, were recruited and randomized to either receive a diary at bedside with psychoeducation or psychoeducation alone. Intervention patients received their ICU diary within the first week of admission into the intensive care unit. Psychological symptom screening with IES-R, PHQ-8, HADS and GAD-7 was conducted at baseline within 1 week of ICU discharge and at weeks 4, 12, and 24 after ICU discharge. Change from baseline in these scores was assessed using Wilcoxon rank sum tests.
RESULTS


From September 26, 2017 to September 25, 2018, our team screened 265 patients from the surgical and medical ICUs at a single large academic urban hospital. 60 patients were enrolled and randomized, of which 35 patients completed post-discharge follow-up, (n = 18) in the diary intervention group and (n = 17) in the education-only control group. The control group had a significantly greater decrease in PTSD, hyperarousal, and depression symptoms at week 4 compared to the intervention group. There were no significant differences in other measures, or at other follow-up intervals. Both study groups exhibited clinically significant PTSD symptoms at all timepoints after ICU discharge. Follow-up phone interviews with patients revealed that while many were interested in getting follow-up for their symptoms, there were many barriers to accessing appropriate therapy and clinical attention.
CONCLUSIONS


Results from psychological screening tools demonstrate no benefit of ICU diaries versus bedside education-alone in reducing PTSD symptoms related to the intensive care stay. However, our study finds an important gap in clinical practice - patients at high risk for PICS are infrequently connected to appropriate follow-up care. Perhaps ICU diaries would prove beneficial if utilized to support the work within a program providing wrap-around services and close psychiatric follow up for PICS patients. This study demonstrates the high prevalence of ICU-related PTSD in our cohort of survivors, the high barrier to accessing care for appropriate treatment of PICS, and the consequence of that barrier-prolonged psychological morbidity.
TRIAL REGISTRATION


NCT04305353.
GRANT IDENTIFICATION


GH-17-022 (Arnold P. Gold Foundation).",2020,"CONCLUSIONS


Results from psychological screening tools demonstrate no benefit of ICU diaries versus bedside education-alone in reducing PTSD symptoms related to the intensive care stay.","['From September 26, 2017 to September 25, 2018, our team screened 265 patients from the surgical and medical ICUs at a single large academic urban hospital', '60 patients', 'Patients with an ICU stay >72\u202fh, who were intubated and mechanically ventilated over 24\u202fh']","['intensive care unit (ICU) diary program', 'diary intervention group and (n\u202f=\u202f17) in the education-only control group', 'diary at bedside with psychoeducation or psychoeducation alone']","['acute PTSD symptoms', 'PTSD symptoms', 'PTSD, hyperarousal, and depression symptoms', 'Psychological symptom screening with IES-R, PHQ-8, HADS and GAD-7']","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0020029', 'cui_str': 'Urban Hospitals'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]","[{'cui': 'C0747767', 'cui_str': 'Acute Post-Traumatic Stress Disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}]",60.0,0.0503067,"CONCLUSIONS


Results from psychological screening tools demonstrate no benefit of ICU diaries versus bedside education-alone in reducing PTSD symptoms related to the intensive care stay.","[{'ForeName': 'George E', 'Initials': 'GE', 'LastName': 'Sayde', 'Affiliation': 'Department of Internal Medicine and Psychiatry, Tulane University of School of Medicine, 1440 Canal Street, Suite 1000, New Orleans, LA 70112, USA. Electronic address: gsayde@tulane.edu.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Stefanescu', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, 1440 Canal Street, New Orleans, LA 70122, USA. Electronic address: astefanescu@tulane.edu.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Conrad', 'Affiliation': 'Department of Psychiatry, Louisiana State University, 2025 Gravier Street, New Orleans, LA 70112, USA. Electronic address: econra@lsuhsc.edu.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Nielsen', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, University of New Mexico School of Medicine, 1 University of New Mexico, Albuquerque, NM 87131, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hammer', 'Affiliation': 'Department of Internal Medicine and Psychiatry, Tulane University of School of Medicine, 1440 Canal Street, Suite 1000, New Orleans, LA 70112, USA. Electronic address: rhammer@tulane.edu.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2020.06.017']
1691,32763649,"Parenting, mental health and economic pathways to prevention of violence against children in South Africa.","BACKGROUND


Parenting programs based on social learning theory have increasing empirical evidence for reducing violence against children. Trials are primarily from high-income countries and with young children. Globally, we know little about how parenting programs work to reduce violence, with no known studies in low or middle-income countries (LMICs). This study examines mechanisms of change of a non-commercialized parenting program, Parenting for Lifelong Health for Teens, designed with the World Health Organization and UNICEF. A cluster randomized trial showed main effects on parenting and other secondary outcomes. We conducted secondary analysis of trial data to investigate five potential mediators of reduced violence against children: improved parenting, adolescent behaviour, caregiver mental health, alcohol/drug avoidance, and family economic strengthening.
METHODS


The trial was implemented in rural South Africa with 40 sites, n = 552 family dyads (including adolescents aged 10-18 and primary caregivers). Intervention sites (n = 20) received the 14-session parenting program delivered by local community members, including modules on family budgeting and savings. Control sites (n = 20) received a brief informational workshop. Emotional and physical violence against children/adolescents and each potential mediator were reported by adolescents and caregivers at baseline and 9-13 months post-randomisation. Structural equation modelling was used to test simultaneous hypothesized pathways to violence reduction.
RESULTS


Improvements in four pathways mediated reduced violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare. Improved child behaviour was not a mediator, although it was associated with less violence.
CONCLUSIONS


Simultaneously bolstering a set of family processes can reduce violence. Supporting self-care and positive coping for caregivers may be essential in challenging contexts. In countries with minimal or no economic safety nets, linking social learning parenting programs with economic strengthening skills may bring us closer to ending violence against children.",2020,"RESULTS


Improvements in four pathways mediated reduced violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare.","['rural South Africa with 40 sites, n\xa0=\xa0552 family dyads (including adolescents aged 10-18 and primary caregivers', 'reduced violence against children', 'Emotional and physical violence against children/adolescents', 'violence against children in South Africa', 'violence against children']","['brief informational workshop', '14-session parenting program delivered by local community members, including modules on family budgeting and savings']","['violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare', 'parenting, adolescent behaviour, caregiver mental health, alcohol/drug avoidance, and family economic strengthening', 'child behaviour']","[{'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1319883', 'cui_str': 'Primary caregiver'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0476480', 'cui_str': 'Physical violence'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0036245', 'cui_str': 'Savings'}]","[{'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",552.0,0.117351,"RESULTS


Improvements in four pathways mediated reduced violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Cluver', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Department of Psychiatry and Mental Health, University of Cape Town, South Africa. Electronic address: lucie.cluver@spi.ox.ac.uk.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Shenderovich', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Institute of Criminology, University of Cambridge, United Kingdom. Electronic address: yulia.shenderovich@spi.ox.ac.uk.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Meinck', 'Affiliation': 'School of Social and Political Science, University of Edinburgh, United Kingdom; Optentia, Faculty of Health Sciences, North-West University, South Africa. Electronic address: Franziska.Meinck@ed.ac.uk.'}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Berezin', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Department of Applied Psychology, New York University, New York, USA. Electronic address: mnb387@nyu.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Doubt', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom. Electronic address: jennydoubt@gmail.com.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Ward', 'Affiliation': 'Department of Psychology, University of Cape Town, South Africa. Electronic address: Catherine.Ward@uct.ac.za.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Parra-Cardona', 'Affiliation': 'Steve Hicks School of Social Work, The University of Texas at Austin, Texas, USA. Electronic address: rparra@austin.utexas.edu.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lombard', 'Affiliation': 'Biostatistics Unit, South African Medical Research Council, South Africa. Electronic address: carl.lombard@mrc.ac.za.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Lachman', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; MRC/CSO Social and Public Health Sciences Unit, University of Glasglow, United Kingdom. Electronic address: jamie.lachman@spi.ox.ac.uk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wittesaele', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom. Electronic address: camille.wittesaele@spi.ox.ac.uk.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Wessels', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Department of Psychology, University of Cape Town, South Africa. Electronic address: inge.wessels@spi.ox.ac.uk.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gardner', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom. Electronic address: frances.gardner@wolfson.ox.ac.uk.'}, {'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Steinert', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; TUM School of Governance, Technical University of Munich, Germany. Electronic address: janina.steinert@tum.de.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113194']
1692,32763776,Effect of brief encouragement to use twitter on knowledge of the critical-care literature by ICU residents: The randomized controlled IMKREASE trial.,,2020,,['ICU residents'],[],[],"[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]",[],[],,0.0232695,,"[{'ForeName': 'Jean Baptiste', 'Initials': 'JB', 'LastName': 'Lascarrou', 'Affiliation': 'Medecine Intensive Reanimation, University Hospital Center, Nantes, France. Electronic address: jeanbaptiste.lascarrou@chu-nantes.fr.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ehrmann', 'Affiliation': 'Medecine Intensive Reanimation, University Hospital Center, Tours, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Potier', 'Affiliation': 'Department of internal medicine, University Hospital Center, Nantes, France. Electronic address: pierre.potier@chu-nantes.fr.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Reignier', 'Affiliation': 'Medecine Intensive Reanimation, University Hospital Center, Nantes, France. Electronic address: jean.reignier@chu-nantes.fr.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Canet', 'Affiliation': 'Medecine Intensive Reanimation, University Hospital Center, Nantes, France. Electronic address: emmanuel.canet@chu-nantes.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of critical care,['10.1016/j.jcrc.2020.07.022']
1693,32763872,Translatability of a Wearable Technology Intervention to Increase Adolescent Physical Activity: Mixed Methods Implementation Evaluation.,"BACKGROUND


Wearable technology interventions combined with digital behavior change resources provide opportunities to increase physical activity in adolescents. The implementation of such interventions in real-world settings is unknown. The Raising Awareness of Physical Activity (RAW-PA) study was a 12-week cluster randomized controlled trial targeting inactive adolescents attending schools in socioeconomically disadvantaged areas of Melbourne, Australia. The aim was to increase moderate- to vigorous-intensity physical activity using (1) a wrist-worn Fitbit Flex and app, (2) weekly challenges, (3) digital behavior change resources, and (4) email or text message alerts.
OBJECTIVE


This paper presents adolescents' and teachers' perceptions of RAW-PA in relation to program acceptability, feasibility and perceived impact, adolescent engagement and adherence, and the potential for future scale-up.
METHODS


A mixed methods evaluation of the RAW-PA study assessed acceptability, engagement, feasibility, adherence, and perceived impact. A total of 9 intervention schools and 144 intervention adolescents were recruited. Only adolescents and teachers (n=17) in the intervention group were included in the analysis. Adolescents completed web-based surveys at baseline and surveys and focus groups postintervention. Teachers participated in interviews postintervention. Facebook data tracked engagement with web-based resources. Descriptive statistics were reported by sex. Qualitative data were analyzed thematically.
RESULTS


Survey data were collected from 142 adolescents at baseline (mean age 13.7 years, SD 0.4 years; 51% males) and 132 adolescents postintervention. A total of 15 focus groups (n=124) and 9 interviews (n=17) were conducted. RAW-PA had good acceptability among adolescents and teachers. Adolescents perceived the intervention content as easy to understand (100/120, 83.3%) and the Fitbit easy to use (112/120; 93.3%). Half of the adolescents perceived the text messages to be useful (61/120; 50.8%), whereas 47.5% (57/120) liked the weekly challenges and 38.3% (46/120) liked the Facebook videos. Facebook engagement declined over time; only 18.6% (22/118) of adolescents self-reported wearing the Fitbit Flex daily postintervention. Adolescents perceived the Fitbit Flex to increase their physical activity motivation (85/120, 70.8%) and awareness (93/119, 78.2%). The web-based delivery facilitated implementation of the intervention, although school-level policies restricting phone use were perceived as potential inhibitors to program roll-out.
CONCLUSIONS


RAW-PA showed good acceptability among adolescents attending schools in socioeconomically disadvantaged areas and their teachers. Low levels of teacher burden enhanced their perceptions concerning the feasibility of intervention delivery. Although adolescents perceived that RAW-PA had short-term positive effects on their motivation to be physically active, adolescent adherence and engagement were low. Future research exploring the feasibility of different strategies to engage adolescents with wearable technology interventions and ways of maximizing system-level embeddedness of interventions in practice would greatly advance the field.",2020,Facebook engagement declined over time; only 18.6% (22/118) of adolescents self-reported wearing the Fitbit Flex daily postintervention.,"['A total of 15 focus groups (n=124) and 9 interviews (n=17) were conducted', 'adolescents attending schools in socioeconomically disadvantaged areas and their teachers', 'Only adolescents and teachers (n=17) in the intervention group were included in the analysis', 'inactive adolescents attending schools in socioeconomically disadvantaged areas of Melbourne, Australia', 'A total of 9 intervention schools and 144 intervention adolescents', '142 adolescents at baseline (mean age 13.7 years, SD 0.4 years; 51% males) and 132 adolescents postintervention', 'adolescents']","['moderate- to vigorous-intensity physical activity using (1) a wrist-worn Fitbit Flex and app, (2) weekly challenges, (3) digital behavior change resources, and (4) email or text message alerts', 'Wearable Technology Intervention', 'RAW-PA']","['acceptability, engagement, feasibility, adherence, and perceived impact', 'good acceptability', 'Facebook engagement', 'physical activity motivation']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0557295', 'cui_str': 'School attendance - finding'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",17.0,0.0406149,Facebook engagement declined over time; only 18.6% (22/118) of adolescents self-reported wearing the Fitbit Flex daily postintervention.,"[{'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Koorts', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Burwood, Australia.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Salmon', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Burwood, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Timperio', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Burwood, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Ball', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Burwood, Australia.'}, {'ForeName': 'Susie', 'Initials': 'S', 'LastName': 'Macfarlane', 'Affiliation': 'Learning Futures, Deakin University, Geelong, Australia.'}, {'ForeName': 'Samuel K', 'Initials': 'SK', 'LastName': 'Lai', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Burwood, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Burwood, Australia.'}, {'ForeName': 'Stephanie E', 'Initials': 'SE', 'LastName': 'Chappel', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Burwood, Australia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': 'School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Nicola D', 'Initials': 'ND', 'LastName': 'Ridgers', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Burwood, Australia.'}]",Journal of medical Internet research,['10.2196/13573']
1694,32764462,"Dietary Intake of Carotenoid-Rich Vegetables Reduces Visceral Adiposity in Obese Japanese men-A Randomized, Double-Blind Trial.","Metabolic syndrome, whose main diagnostic component is obesity, is a risk factor for lifestyle-related diseases, type 2 diabetes, and cardiovascular disease. Diet is known to affect the prevalence of metabolic syndrome. However, the effect of diet on metabolic syndrome in Japanese subjects has not been thoroughly explored. In the present study, we investigated the effect of carotenoid-rich vegetables, particularly lycopene- and lutein-rich vegetables, on the metabolic syndrome in obese Japanese men. We conducted an 8-week long randomized, double-blinded, controlled clinical trial in which, 28 middle-aged (40 ≤ age < 65) Japanese men with high body mass index (BMI ≥ 25) were randomized into four dietary groups: high lycopene + high lutein (HLyHLu), high lycopene + low lutein (HLyLLu), low lycopene + high lutein (LLyHLu), and low lycopene + low lutein (LLyLLu). Our results showed that daily beverage-intake increased the plasma levels of carotenoids without adverse effects, and the visceral fat level was significantly decreased in all the groups. The waist circumference was significantly decreased only in the HLyLLu group, whereas the CoQ10 oxidation rate was decreased in all the groups. The gene expression profiles of whole blood samples before and after ingestion differed only in the LLyLLu group, indicating the effect of carotenoids on gene expression profile. In conclusion, our results suggest that dietary uptake of carotenoid-rich vegetables increases their concentration in blood and reduces the intra-abdominal visceral fat.",2020,"The waist circumference was significantly decreased only in the HLyLLu group, whereas the CoQ10 oxidation rate was decreased in all the groups.","['Japanese subjects', '28 middle-aged (40 ≤ age < 65) Japanese men with high body mass index (BMI ≥ 25', 'Obese Japanese men', 'obese Japanese men']","['lycopene + high lutein (HLyHLu), high lycopene + low lutein (HLyLLu), low lycopene + high lutein (LLyHLu), and low lycopene + low lutein (LLyLLu', 'carotenoid-rich vegetables, particularly lycopene- and lutein-rich vegetables', 'Carotenoid-Rich Vegetables']","['waist circumference', 'intra-abdominal visceral fat', 'Visceral Adiposity', 'plasma levels of carotenoids without adverse effects', 'metabolic syndrome', 'CoQ10 oxidation rate', 'visceral fat level']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0065331', 'cui_str': 'lycopene'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}]",,0.081307,"The waist circumference was significantly decreased only in the HLyLLu group, whereas the CoQ10 oxidation rate was decreased in all the groups.","[{'ForeName': 'Tomohisa', 'Initials': 'T', 'LastName': 'Takagi', 'Affiliation': 'Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto 602-8566, Japan.'}, {'ForeName': 'Ryotaro', 'Initials': 'R', 'LastName': 'Hayashi', 'Affiliation': 'Nippon Flour Mills Co., Ltd., Innovation Center, Kanagawa 243-0041, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Nakai', 'Affiliation': 'Section of Food Sciences, Institute of Regional Innovation, Hirosaki University, Aomori 038-0012, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Okada', 'Affiliation': 'Graduate School of Agricultural and Life Sciences, The University of Tokyo, Tokyo 113-8654, Japan.'}, {'ForeName': 'Rumiko', 'Initials': 'R', 'LastName': 'Miyashita', 'Affiliation': 'Nippon Flour Mills Co., Ltd., Innovation Center, Kanagawa 243-0041, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Yamada', 'Affiliation': 'Clinical Research Support Office, National Cancer Center Hospital East, Kashiwa 277-8577, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Mihara', 'Affiliation': 'NK Medico co., LTD., Tokyo 105-0012, Japan.'}, {'ForeName': 'Katsura', 'Initials': 'K', 'LastName': 'Mizushima', 'Affiliation': 'Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto 602-8566, Japan.'}, {'ForeName': 'Mayuko', 'Initials': 'M', 'LastName': 'Morita', 'Affiliation': 'Health Care Nutrition, Showa Gakuin Junior College, Chiba 272-0823, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Uchiyama', 'Affiliation': 'Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto 602-8566, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Naito', 'Affiliation': 'Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto 602-8566, Japan.'}, {'ForeName': 'Yoshito', 'Initials': 'Y', 'LastName': 'Itoh', 'Affiliation': 'Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto 602-8566, Japan.'}]",Nutrients,['10.3390/nu12082342']
1695,32764474,Effect of Experiential Vegetable Education Program on Mediating Factors of Vegetable Consumption in Australian Primary School Students: A Cluster-Randomized Controlled Trial.,"Schools provide a relevant and equitable environment to influence students towards increased vegetable consumption. This study aimed to evaluate the effectiveness of a Vegetable Education Resource To Increase Children's Acceptance and Liking (VERTICAL) for Australian primary schools (curriculum aligned and based on a framework of food preference development and sensory experiential learning) on positively influencing factors predisposing children towards increased vegetable consumption. The secondary aim was to evaluate two levels of teacher training intensity on intervention effectiveness. A cluster-RCT amongst schools with three conditions was conducted: 1 = teaching VERTICAL preceded by online teacher training; 2 = as per 1 with additional face-to-face teacher training; 3 = Control. Pre-test, post-test and 3-month follow-up measures (knowledge, verbalization ability, vegetable acceptance, behavioural intentions, willing to taste, new vegetables consumed) were collected from students ( n  = 1639 from 25 schools in Sydney/Adelaide, Australia). Data were analyzed using mixed model analysis. No difference in intervention effectiveness was found between the two training methods. Compared to the Control, VERTICAL positively affected all outcome measures after intervention ( p  < 0.01) with knowledge sustained at 3-month follow-up ( p  < 0.001). In conclusion, VERTICAL was effective in achieving change amongst students in mediating factors known to be positively associated with vegetable consumption.",2020,"Compared to the Control, VERTICAL positively affected all outcome measures after intervention ( p  < 0.01) with knowledge sustained at 3-month follow-up ( p  < 0.001).",['Australian Primary School Students'],"['Vegetable Education Resource', 'online teacher training', 'Experiential Vegetable Education Program']","['Mediating Factors of Vegetable Consumption', 'intervention effectiveness']","[{'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C4082803', 'cui_str': 'Teacher Training'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0717293,"Compared to the Control, VERTICAL positively affected all outcome measures after intervention ( p  < 0.01) with knowledge sustained at 3-month follow-up ( p  < 0.001).","[{'ForeName': 'Astrid A M', 'Initials': 'AAM', 'LastName': 'Poelman', 'Affiliation': 'Sensory and Consumer Science, CSIRO Agriculture and Food, North Ryde, NSW 2113, Australia.'}, {'ForeName': 'Maeva', 'Initials': 'M', 'LastName': 'Cochet-Broch', 'Affiliation': 'Sensory and Consumer Science, CSIRO Agriculture and Food, North Ryde, NSW 2113, Australia.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Wiggins', 'Affiliation': 'Public Health Nutrition, CSIRO Health and Biosecurity, Adelaide, SA 5000, Australia.'}, {'ForeName': 'Rod', 'Initials': 'R', 'LastName': 'McCrea', 'Affiliation': 'Adaptive Communities and Industries Group, CSIRO Land and Water, Dutton Park, QLD 4102, Australia.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Heffernan', 'Affiliation': 'Sensory and Consumer Science, CSIRO Agriculture and Food, North Ryde, NSW 2113, Australia.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Beelen', 'Affiliation': 'Sensory and Consumer Science, CSIRO Agriculture and Food, North Ryde, NSW 2113, Australia.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Cox', 'Affiliation': 'Public Health Nutrition, CSIRO Health and Biosecurity, Adelaide, SA 5000, Australia.'}]",Nutrients,['10.3390/nu12082343']
1696,32764524,Associations of Lifestyle Intervention Effect with Blood Pressure and Physical Activity among Community-Dwelling Older Americans with Hypertension in Southern California.,"A healthy lifestyle and regular physical activity are highly recommended for older adults. However, there has been limited research into testing lifestyle intervention effects on physical activity in older adults with hypertension. The purpose of this study was to assess the association of lifestyle intervention effects with physical activity and blood pressure in older adults with hypertension, accounting for social support and perceived stress as control variables. This study performed a secondary analysis of a two-arm randomized controlled trial. A total of 196 participants were randomly assigned to a six-month lifestyle intervention group or a control group. Hierarchical multiple regression analyses demonstrated that lifestyle intervention effects were not significantly associated with improvements in physical activity and blood pressure, but the final regression models were statistically significant (all  p  < 0.001). The result revealed that only physical activity frequency at baseline was significantly related to improvement in physical activity. Systolic blood pressure (SBP) at baseline and monthly income were significantly associated with change in SBP, while age and diastolic blood pressure (DBP) at baseline were significantly related to change in DBP. The findings provide empirical evidence for developing and optimizing lifestyle interventions for future research and clinical practice in this population.",2020,"Hierarchical multiple regression analyses demonstrated that lifestyle intervention effects were not significantly associated with improvements in physical activity and blood pressure, but the final regression models were statistically significant (all  p  < 0.001).","['older adults with hypertension', 'Community-Dwelling Older Americans with Hypertension in Southern California', 'A total of 196 participants', 'older adults']","['lifestyle intervention group or a control group', 'physical activity and blood pressure', 'Blood Pressure and Physical Activity']","['physical activity frequency', 'physical activity', 'physical activity and blood pressure', 'Systolic blood pressure (SBP', 'diastolic blood pressure (DBP']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517625', 'cui_str': '196'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",196.0,0.0192055,"Hierarchical multiple regression analyses demonstrated that lifestyle intervention effects were not significantly associated with improvements in physical activity and blood pressure, but the final regression models were statistically significant (all  p  < 0.001).","[{'ForeName': 'Mei-Lan', 'Initials': 'ML', 'LastName': 'Chen', 'Affiliation': 'Byrdine F. Lewis College of Nursing and Health Professions, Georgia State University, Atlanta, GA 30303, USA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'College of Nursing, The Ohio State University, Columbus, OH 43210, USA.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'McCoy', 'Affiliation': 'School of Nursing, University of North Carolina at Greensboro, Greensboro, NC 27402, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Letvak', 'Affiliation': 'School of Nursing, University of North Carolina at Greensboro, Greensboro, NC 27402, USA.'}, {'ForeName': 'Luba', 'Initials': 'L', 'LastName': 'Ivanov', 'Affiliation': 'College of Nursing, Chamberlain University, Downers Grove, IL 60515, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17165673']
1697,32739493,Patient-centered and efficacious advance care planning in cancer: Protocol and key design considerations for the PEACe-compare trial.,"BACKGROUND


Failure to deliver care near the end of life that reflects the needs, values and preferences of patients with advanced cancer remains a major shortcoming of our cancer care delivery system.
METHODS


A mixed-methods comparative effectiveness trial of in-person advance care planning (ACP) discussions versus web-based ACP is currently underway at oncology practices in Western Pennsylvania. Patients with advanced cancer and their caregivers are invited to enroll. Participants are randomized to either (1) in-person ACP discussions via face-to-face visits with a nurse facilitator following the Respecting Choices® Conversation Guide or (2) web-based ACP using the PREPARE for your care™ web-based ACP tool. The trial compares the effect of these two interventions on patient and family caregiver outcomes (engagement in ACP, primary outcome; ACP discussions; advance directive (AD) completion; quality of end-of-life (EOL) care; EOL goal attainment; caregiver psychological symptoms; healthcare utilization at EOL) and assesses implementation costs. Factors influencing ACP effectiveness are assessed via in-depth interviews with patients, caregivers and clinicians.
DISCUSSION


This trial will provide new and much-needed empirical evidence about two patient-facing ACP approaches that successfully overcome limitations of traditional written advance directives but entail very different investments of time and resources. It is innovative in using mixed methods to evaluate not only the comparative effectiveness of these approaches, but also the contexts and mechanisms influencing effectiveness. Data from this study will inform clinicians, payers and health systems seeking to adopt and scale the most effective and efficient ACP strategy in real-world oncology settings.",2020,"The trial compares the effect of these two interventions on patient and family caregiver outcomes (engagement in ACP, primary outcome; ACP discussions; advance directive (AD) completion; quality of end-of-life (EOL) care; EOL goal attainment; caregiver psychological symptoms; healthcare utilization at EOL) and assesses implementation costs.","['Patients with advanced cancer and their caregivers are invited to enroll', 'patients with advanced cancer']","['person advance care planning (ACP) discussions versus web-based ACP', 'person ACP discussions via face-to-face visits with a nurse facilitator following the Respecting Choices® Conversation Guide or (2) web-based ACP using the PREPARE for your care™ web-based ACP tool']","['patient and family caregiver outcomes (engagement in ACP, primary outcome; ACP discussions; advance directive (AD) completion; quality of end-of-life (EOL) care; EOL goal attainment; caregiver psychological symptoms; healthcare utilization at EOL) and assesses implementation costs', 'ACP effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.133077,"The trial compares the effect of these two interventions on patient and family caregiver outcomes (engagement in ACP, primary outcome; ACP discussions; advance directive (AD) completion; quality of end-of-life (EOL) care; EOL goal attainment; caregiver psychological symptoms; healthcare utilization at EOL) and assesses implementation costs.","[{'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Resick', 'Affiliation': 'Palliative Research Center (PaRC), Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Pittsburgh, PA, 15213, USA. Electronic address: jmr58@pitt.edu.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Arnold', 'Affiliation': 'Palliative Research Center (PaRC), Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Pittsburgh, PA, 15213, USA. Electronic address: rabob@pitt.edu.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Sudore', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, San Francisco, USA; San Francisco Veterans Affairs Health Care System, SFVAMC 4150 Clement Street, #151R, San Francisco, CA 94121, USA. Electronic address: Rebecca.Sudore@ucsf.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Farrell', 'Affiliation': 'People Designs, Inc., 1304 Broad Street, Durham, NC 27705, USA. Electronic address: dfarrell@peopledesigns.com.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Belin', 'Affiliation': 'Palliative Research Center (PaRC), Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Pittsburgh, PA, 15213, USA. Electronic address: belin@pitt.edu.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Althouse', 'Affiliation': 'Center for Research on Health Care Data Center, University of Pittsburgh School of Medicine, 200 Meyran Avenue, Suite 300, Pittsburgh, PA 15213, USA. Electronic address: ada62@pitt.edu.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Ferrell', 'Affiliation': 'Division of Nursing Research and Education, Department of Population Sciences, City of Hope Medical Center, 1500 Duarte Road, Duarte, CA 91010, USA. Electronic address: BFerrell@coh.org.'}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Hammes', 'Affiliation': 'Respecting Choices, A Division of C-TAC Innovations, PO Box 258, Oregon, WI 53575-0258, USA. Electronic address: bhammes@respectingchoices.org.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Chu', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology and Cancer Therapeutics Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: chue2@upmc.edu.'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'White', 'Affiliation': 'University of Pittsburgh, School of Medicine, Department of Critical Care Medicine, Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Program on Ethics and Decision Making, 600 Scaife Hall, 3550 Terrace Street, Pittsburgh, PA 15213, USA. Electronic address: douglas.white@pitt.edu.'}, {'ForeName': 'Kimberly J', 'Initials': 'KJ', 'LastName': 'Rak', 'Affiliation': 'University of Pittsburgh, School of Medicine, Department of Critical Care Medicine, Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Program on Ethics and Decision Making, 3520 Fifth Ave, Suite100, Pittsburgh, PA 15213, USA. Electronic address: kjr8@pitt.edu.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Schenker', 'Affiliation': 'Palliative Research Center (PaRC), Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Pittsburgh, PA, 15213, USA. Electronic address: yas28@pitt.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106071']
1698,32739494,Cancer history and risk factors in healthy older people enrolling in the ASPREE clinical trial.,"BACKGROUND


Cancer is a leading cause of death globally. Given the elevated risk of cancer with age and an ageing population, it is important to understand the changing burden of cancer in older populations. The ASPirin in Reducing Events in the Elderly (ASPREE) study randomised healthy older individuals to 100 mg aspirin or placebo, with clinical outcomes and disability-free survival endpoints. Detailed baseline data provides a rare opportunity to explore cancer burden in a uniquely healthy older population.
METHODS


At study enrolment (2010-2014), self-reported personal cancer history, cancer type and cancer risk factor data were sought from 19,114 participants (Australia, n = 16,703; U.S., n = 2411). Eligible participants were healthy, free of major diseases and expected to survive 5 years.
RESULTS


Nearly 20% of enrolling ASPREE participants reported a prior cancer diagnosis; 18% of women and 22% of men, with women diagnosed younger (16% vs 6% of diagnoses <50 years). Cancer prevalence increased with age. Prevalence of prostate and breast cancer history were higher in U.S. participants; melanoma and colorectal cancer were higher in Australian participants. Cancer history prevalence was not associated with contemporary common risk factors nor previous aspirin use, but was associated with poor health ratings in men. Blood and breast cancer history were more common with past aspirin use.
CONCLUSIONS


Personal cancer history in healthy older ASPREE participants was as expected for the most common cancer types in the respective populations, but was not necessarily aligned with known risk factors. We attribute this to survivor bias, likely driven by entry criteria.
TRIAL REGISTRATION


International Standard Randomised Controlled Trial Number Register (ISRCTN83772183) and clinicaltrials.gov (NCT01038583).",2020,Prevalence of prostate and breast cancer history were higher in U.S. participants; melanoma and colorectal cancer were higher in Australian participants.,"['healthy older individuals to 100\u202fmg', 'Eligible participants were healthy, free of major diseases and expected to survive 5\u202fyears', 'healthy older ASPREE participants', 'healthy older people enrolling', 'At study enrolment (2010-2014), self-reported personal cancer history, cancer type and cancer risk factor data were sought from 19,114 participants (Australia, n\u202f=\u202f16,703; U.S., n\u202f=\u202f2411', 'uniquely healthy older population']","['ASPirin', 'aspirin or placebo']","['Cancer history and risk factors', 'Prevalence of prostate and breast cancer history', 'Cancer prevalence']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]",19114.0,0.463069,Prevalence of prostate and breast cancer history were higher in U.S. participants; melanoma and colorectal cancer were higher in Australian participants.,"[{'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Orchard', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Suzanne.orchard@monash.edu.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Jessica.lockery@monash.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gibbs', 'Affiliation': 'The Walter & Eliza Hall Institute of Medical Research, University of Melbourne,1G Royal Parade, Parkville, Victoria 3052, Australia. Electronic address: Peter.gibbs@petermac.org.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Polekhina', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Galhina.polekhina@monash.edu.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Rory.wolfe@monash.edu.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zalcberg', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: John.zalcberg@monash.edu.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haydon', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Andrew.haydon@monash.edu.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: John.mcneil@monash.edu.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, 17 Liverpool St (Private Bag 23), Hobart 7000, Tasmania, Australia. Electronic address: Mark.nelson@utas.edu.au.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'School of Public Health, Curtin University, Kent Street, Bentley, Perth 6102, Western Australia, Australia. Electronic address: Christpher.reid@curtin.edu.au.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Kirpach', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute (HHRI), 701 Park Avenue, Suite PP7.700, Minneapolis 55415, Minnesota, USA. Electronic address: bkirpach@bermancenter.org.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute (HHRI), 701 Park Avenue, Suite PP7.700, Minneapolis 55415, Minnesota, USA; Division of Geriatrics, Department of Medicine, Hennepin Healthcare and University of Minnesota, East River Parkway, Minneapolis 55455, Minnesota, USA. Electronic address: AMurray@bermancenter.org.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Robyn.woods@monash.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106095']
1699,32739704,Aerobic exercise or stretching as add-on to inpatient treatment of depression: Similar antidepressant effects on depressive symptoms and larger effects on working memory for aerobic exercise alone.,"BACKGROUND


Aerobic exercise (AE) has positive effects on symptom severity and cognitive symptoms of depression. Since data on AE as add-on to inpatient treatment in depression is still scarce, we conducted this double-blind randomized controlled study.
METHODS


Patients aged between 18 and 60 years were recruited into the study if Hamilton Depression Rating Scale 17 (HDRS-17) score was >16. Participants were randomly assigned to either AE or basic stretching activities (control), which took place 3x/week for 6 weeks. Primary outcome was depression severity as assessed with the HDRS-17 and the Beck Depression Inventory (BDI). Further physiological and psychological variables and cognitive performance were assessed as secondary outcomes.
RESULTS


Forty-two patients were included in the analysis (exercise: n = 22; control: n = 20). Regardless of group allocation, we found a significant short-term time effect for symptom-severity (HDRS17: p<0.001, η²=0.70; BDI: p<0.001, η²=0.51), mental toughness (p<0.001, η²=0.32), physical self-description endurance score (p = 0.013, η²=0.16), cognitive flexibility (p = 0.013, η²=0.14), and body mass index (BMI) (p = 0.006, η²=0.19). Working memory showed a significant time by group interaction in favor of AE (p = 0.043, η²=0.10). Short-term effects on symptom severity, mental toughness and BMI remained stable across the 6-month follow-up period. Finally, self-reported physical activity increased significantly from baseline to follow-up (p = 0.014, η²=0.15).
LIMITATIONS


The sample-size is rather small. The control intervention might have been too active as to find a time by group interaction for symptom severity.
CONCLUSIONS


AE was associated with comparably large depression alleviation vs. stretching and with add-on benefits on working memory.",2020,"Short-term effects on symptom severity, mental toughness and BMI remained stable across the 6-month follow-up period.","['Forty-two patients were included in the analysis (exercise: n\xa0=\xa022; control: n\xa0=\xa020', 'Patients aged between 18 and 60 years']","['Aerobic exercise or stretching', 'Aerobic exercise (AE', 'AE or basic stretching activities (control', 'aerobic exercise alone']","['mental toughness', 'depression severity as assessed with the HDRS-17 and the Beck Depression Inventory (BDI', 'physical activity', 'symptom severity, mental toughness and BMI', 'physical self-description endurance score', 'Hamilton Depression Rating Scale 17 (HDRS-17) score', 'cognitive flexibility', 'body mass index (BMI']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",42.0,0.225194,"Short-term effects on symptom severity, mental toughness and BMI remained stable across the 6-month follow-up period.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Imboden', 'Affiliation': 'Psychiatric Services Solothurn, Solothurn, Switzerland, and University of Basel, Basel, Switzerland; Private Clinic Wyss, Muenchenbuchsee, Switzerland. Electronic address: christian.imboden@pkwyss.ch.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Gerber', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Beck', 'Affiliation': 'Psychiatric University Hospital, University of Basel, Basel, Switzerland; Private Clinic Sonnenhalde, Riehen, Switzerland.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Holsboer-Trachsler', 'Affiliation': 'Psychiatric University Hospital, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Pühse', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hatzinger', 'Affiliation': 'Psychiatric Services Solothurn, Solothurn, Switzerland, and University of Basel, Basel, Switzerland.'}]",Journal of affective disorders,['10.1016/j.jad.2020.07.052']
1700,32739716,The comparison of access to an eHealth resource to current practice on mother and co-parent teamwork and breastfeeding rates: A randomized controlled trial.,"BACKGROUND


Breastfeeding rates are suboptimal, putting mothers and their infants' health at risk. One modifiable risk factor amenable to intervention is partner support. Having women work as a team with their co-parents to meet their breastfeeding goals has been found to improve breastfeeding outcomes. eHealth resources have been found to be accessible and feasible ways to provide breastfeeding education yet, the best way to design breastfeeding interventions for mothers and their co-parents is not known.
OBJECTIVES


To compare two study conditions to determine: (1) which way is more effective to provide breastfeeding education to women and their co-parents on increasing breastfeeding rates and associated secondary outcomes, such as breastfeeding knowledge, attitude, self-efficacy and overcoming challenges; (2) the difference in co-parenting and partner support between the study groups; (3) how parents in both groups preferred to access breastfeeding information; and (4) the groups' satisfaction with the eHealth resource that was provided.
DESIGN


This study used a randomized controlled trial design (Clinicaltrials.org #NCT03492411). Participants were randomly allocated to study groups with concealed opaque envelopes by a blinded research assistant. Participants in Study Condition #1 (SC1) accessed a previously created, online e-Health resource, in addition to other generally available resources they could access in the community; participants in Study Condition #2 (SC2) accessed only the generally available resources.
SETTING


Participants were recruited in health care providers' offices and services for expectant parents in Ontario and via social media throughout Canada.
PARTICIPANTS


Expectant women (n = 113) and their co-parents (n = 104) were enrolled.
METHODS


After eligibility was determined, consents obtained and baseline surveys completed, group allocation was conducted. SC1 had a virtual meeting with a research assistant to review the eHealth resource. Weekly emails were sent to all participants for 6 weeks as reminders. Follow-up data were electronically collected from mothers and co-parents at 2 weeks post enrollment and 4, 12, 26 and 52-weeks postpartum.
RESULTS


Breastfeeding rates were high in both groups (SC1 63% and SC2 57% 'exclusive' 6 months) and (SC1 71% and SC2 78% 'any' 12 months) and not statistically significantly different. High scores were found in both groups in secondary outcome measures. Generally available breastfeeding resources were used in both groups with websites being used often and rated as most helpful. SC1 rated the eHealth resource provided to them highly.
CONCLUSION


The findings suggest both mothers and their co-parents should be targeted in breastfeeding education and web-based resources designed to meet their needs.",2020,"RESULTS


Breastfeeding rates were high in both groups (SC1 63% and SC2 57% 'exclusive' 6 months) and (SC1 71% and SC2 78% 'any' 12 months) and not statistically significantly different.","['Expectant women (n\xa0=\xa0113) and their co-parents (n\xa0=\xa0104) were enrolled', 'Participants in Study Condition', ""Participants were recruited in health care providers' offices and services for expectant parents in Ontario and via social media throughout Canada""]",[],['Breastfeeding rates'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]",[],"[{'cui': 'C0006147', 'cui_str': 'Breast fed'}]",104.0,0.0703829,"RESULTS


Breastfeeding rates were high in both groups (SC1 63% and SC2 57% 'exclusive' 6 months) and (SC1 71% and SC2 78% 'any' 12 months) and not statistically significantly different.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Abbass-Dick', 'Affiliation': 'Faculty of Health Sciences, Ontario Tech University, 2000 Simcoe Street North, Oshawa ON, L1G 0C5, Canada. Electronic address: jennifer.abbassdick@ontariotechu.ca.'}, {'ForeName': 'Winnie', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Faculty of Health Sciences, Ontario Tech University, 2000 Simcoe Street North, Oshawa ON, L1G 0C5, Canada.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Newport', 'Affiliation': 'Durham Region Health Department, Canada.'}, {'ForeName': 'Fangli', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Durham Region Health Department, Canada.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Godfrey', 'Affiliation': 'Durham Region Health Department, Canada.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Goodman', 'Affiliation': 'Faculty of Business and Information Technology, Ontario Tech University.'}]",Midwifery,['10.1016/j.midw.2020.102812']
1701,32739846,Comparison of topical capsaicin and topical piroxicam in the treatment of acute trauma-induced pain: A randomized double-blind trial.,"BACKGROUND


This study aimed to compare the analgesic efficacy of topical capsaicin and topical piroxicam in acute musculoskeletal injuries.
METHODS


This is a prospective, randomized, controlled, double-blinded study. The data for the 67 patients in the piroxicam group and the 69 in the capsaicin group were examined. The initial visual analog scale (VAS) scores were compared with the 60th and 120th minute as well as the 24th and 72nd hour values. Differences between the VAS scores, clinical effectiveness of the treatment and side effects were evaluated.
RESULTS


In the capsaicin group, the mean difference in the delta VAS scores was significantly higher at each measurement time. The mean of the percentage of reduction in the VAS scores of the topical capsaicin group was significantly higher than that in the topical piroxicam group. The highest difference in terms of both outcomes was determined at the 72nd hour VAS change. Mean differences were 1.53 (95% CI: 0.85-2.221) and 19.7 (95% CI: 12.4-27.2) respectively (p < 0.001). In the capsaicin group, the clinical effect of the treatment was found significantly higher (p < 0.01). The difference between the clinical effectiveness of the groups regarding the treatment outcomes was also statistically significant (p < 0.001). There was no significant difference between the patient groups regarding the presence of side effects.
CONCLUSION


Topical capsaicin can be used as an alternative to topical piroxicam initially and at follow-up in patients presenting to the emergency department with acute pain as there were no observable differences in side-effects between the two groups.",2020,"In the capsaicin group, the clinical effect of the treatment was found significantly higher (p < 0.01).","['patients presenting to the emergency department with acute pain', 'acute musculoskeletal injuries', 'acute trauma-induced pain', '67 patients in the']","['topical capsaicin', 'topical capsaicin and topical piroxicam', 'piroxicam', 'capsaicin', 'Topical capsaicin', 'topical piroxicam']","['VAS scores, clinical effectiveness of the treatment and side effects', 'side effects', 'delta VAS scores', 'analgesic efficacy', 'initial visual analog scale (VAS) scores', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0272448', 'cui_str': 'Injury of musculoskeletal system'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C3210186', 'cui_str': 'Capsaicin-containing product in transdermal dose form'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0031990', 'cui_str': 'Piroxicam'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0861012,"In the capsaicin group, the clinical effect of the treatment was found significantly higher (p < 0.01).","[{'ForeName': 'Abdullah Osman', 'Initials': 'AO', 'LastName': 'Kocak', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey. Electronic address: abdullahmrym86@gmail.com.'}, {'ForeName': 'Sinem', 'Initials': 'S', 'LastName': 'Dogruyol', 'Affiliation': 'Department of Emergency Medicine, Manisa Merkez Efendi State Hospital, Manisa, Turkey.'}, {'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Akbas', 'Affiliation': 'Department of Emergency Medicine, Bingol State Hospital, Bingol, Turkey.'}, {'ForeName': 'Tugba Sanalp', 'Initials': 'TS', 'LastName': 'Menekse', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Sultan Tuna Akgol', 'Initials': 'STA', 'LastName': 'Gur', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Meryem Betos', 'Initials': 'MB', 'LastName': 'Kocak', 'Affiliation': 'Department of Familiy Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Cekmen', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Karabuk University, Karabuk, Turkey.'}, {'ForeName': 'Serhat', 'Initials': 'S', 'LastName': 'Orun', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Namik Kemal University, Tekirdağ, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Cakir', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2020.05.104']
1702,32739862,Benefits of social cognitive skills training within routine community mental health services: Evidence from a non-randomized parallel controlled study.,"Although social cognitive impairments are evident in patients with schizophrenia across many cultures, psychosocial interventions are less used in Eastern countries. Despite a growing emphasis on community care in mental health services in Eastern countries, the synergistic effects of social cognitive intervention strategies on routine community mental health services are not well documented. This study aimed to adapt a group-based social cognitive skills training (SCST) program for use in a Korean context and evaluate its feasibility and preliminary effects among community-dwelling individuals with schizophrenia. Forty-seven patients were assigned to either the SCST + treatment as usual (TAU) group (n = 21) or the TAU only group (n = 24). Participants completed tasks to assess social cognition, social functioning, neurocognition, and psychiatric symptoms before and after treatment. Over a period of approximately 12 weeks, drop-out rates were comparably low in both groups, and the attendance rates for the SCST program were high (85.7 %, mean sessions attended = 20.56/24 sessions). The SCST + TAU group demonstrated significant improvements in facial affect recognition, social functioning, and psychiatric symptoms compared to the TAU only group. A non-significant trend in theory of mind was observed, along with no improvements in social perception and neurocognition. The adapted version of the SCST program is feasible for implementation and demonstrates promise for enhancing social cognition and functioning in Korean outpatients with schizophrenia.",2020,The adapted version of the SCST program is feasible for implementation and demonstrates promise for enhancing social cognition and functioning in Korean outpatients with schizophrenia.,"['mental health services in Eastern countries', 'community-dwelling individuals with schizophrenia', 'Korean outpatients with schizophrenia', 'Forty-seven patients', 'routine community mental health services', 'patients with schizophrenia']","['TAU', 'social cognitive skills training', 'social cognitive skills training (SCST) program', 'SCST + TAU', 'SCST program', 'SCST + treatment as usual (TAU']","['social cognition, social functioning, neurocognition, and psychiatric symptoms', 'facial affect recognition, social functioning, and psychiatric symptoms', 'attendance rates', 'social perception and neurocognition']","[{'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009475', 'cui_str': 'Mental Health Services, Community'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0579088', 'cui_str': 'Cognitive skills training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0037427', 'cui_str': 'Perception, Social'}]",47.0,0.0204504,The adapted version of the SCST program is feasible for implementation and demonstrates promise for enhancing social cognition and functioning in Korean outpatients with schizophrenia.,"[{'ForeName': 'Jae Eun', 'Initials': 'JE', 'LastName': 'Lim', 'Affiliation': 'Department of Psychology, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Ye-Jin', 'Initials': 'YJ', 'LastName': 'Kwon', 'Affiliation': 'Department of Psychology, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Soo-Yun', 'Initials': 'SY', 'LastName': 'Jung', 'Affiliation': 'Department of Psychology, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Kiho', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Department of Psychology, Korea University, Seoul, Republic of Korea; Korea University Mind Health Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Wonhye', 'Initials': 'W', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Psychology, National Center for Mental Health, Seoul, Republic of Korea.'}, {'ForeName': 'Seung-Hwan', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Inje University Ilsan-Paik Hospital, Goyang, Republic of Korea.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'P Horan', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Kee-Hong', 'Initials': 'KH', 'LastName': 'Choi', 'Affiliation': 'Department of Psychology, Korea University, Seoul, Republic of Korea; Korea University Mind Health Institute, Seoul, Republic of Korea; Department of Psychology, Wesleyan University, Middletown, USA. Electronic address: kchoi1@korea.ac.kr.'}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.102314']
1703,32740449,"Factors Associated with the Recurrence, Persistence and Clearance of Asymptomatic Bacterial Vaginosis among Young African American Women: A Repeated Measures Latent Class Analysis.","BACKGROUND


While risk factors of recurrent and persistent bacterial vaginosis (BV) have been explored in the literature, the longitudinal incidence patterns of BV remain elusive.
METHODS


We conducted a secondary analysis of longitudinal data from a randomized clinical trial of metronidazole treatment for asymptomatic BV. Repeated Measures Latent Class Analysis (RMLCA) was used to identify distinct longitudinal patterns of incident BV cases. Multinomial regression analysis was used to determine the predictors of class membership. The multivariable model included age, last BV treatment, douching frequency, birth control, sexual risk behavior and assignment to treatment arm.
RESULTS


A total of 858 African American women, asymptomatic for BV were included in the analysis. Three emergent patterns of BV over 12-months were identified by RMLCA: persistent (55.9%), recurrent (30.5%) and clearance (13.5%). Participants who had douched at least once had significantly lower odds to be in the recurrent class versus the clearance class (adjusted Odds Ratio [adjOR]: 0.55; 95% Confidence Interval [CI]: 0.18-0.63). Women who had sex with women (WSW) had significantly lower odds of belonging to the persistent class versus the clearance class (adjOR: 0.38; 95% CI: 0.22-0.68) and the recurrent class (adjOR: 0.43; 95% CI: 0.23-0.81). Those who were assigned to the treatment arm had significantly increased odds of being in the recurrent class versus the clearance class (adjOR: 1.92; 95% CI: 1.22-3.03). Women >21 years were significantly more likely to be in the recurrent class (adjOR: 1.88; 95% CI: 1.17-3.00) than in the clearance class.
CONCLUSION


Assessment of BV cases revealed distinct patterns of recurrence and persistence of BV which were significantly associated with douching, being in the treatment arm, and being a woman who had sex with women.",2020,Participants who had douched at least once had significantly lower odds to be in the recurrent class versus the clearance class (adjusted Odds Ratio [adjOR]: 0.55; 95% Confidence Interval [CI]: 0.18-0.63).,"['asymptomatic BV', 'Young African American Women', '858 African American women, asymptomatic for BV', 'Women who had sex with women (WSW', 'woman who had sex with women']",['metronidazole'],"['recurrence and persistence of BV', 'Recurrence, Persistence and Clearance of Asymptomatic Bacterial Vaginosis']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1533642', 'cui_str': 'Women Who Have Sex With Women'}]","[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}]",858.0,0.0658257,Participants who had douched at least once had significantly lower odds to be in the recurrent class versus the clearance class (adjusted Odds Ratio [adjOR]: 0.55; 95% Confidence Interval [CI]: 0.18-0.63).,"[{'ForeName': 'Makella S', 'Initials': 'MS', 'LastName': 'Coudray', 'Affiliation': '1Department of Epidemiology, Robert Stempel College of Public Health and Social Work, Florida International University (FIU), Miami, FL 2 Center for Research on U.S. Latino HIV/AIDS and Drug Abuse, FIU, Miami, FL 3 Research Center in Minority Institutions, FIU, Miami, FL 4Department of Biostatistics, Robert Stempel College of Public Health and Social Work, FIU, Miami, FL 5Department of Epidemiology, College of Public Health and Health Professions, University of Florida (UF), Gainesville, FL 6Department of Medicine, Division of General Internal Medicine, UF, Gainesville, FL 7Department of Medicine, University of Alabama at Birmingham, Birmingham, AL 8 Department of Health Promotion Sciences, Mel & Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ 9Division of Infectious Diseases, College of Medicine, University of Arizona, Tucson, AZ 10Department of Family & Community Medicine, College of Medicine, University of Arizona, Tucson, AZ 11Public Health Research Institute of India, Mysore, Karnataka, India.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Sheehan', 'Affiliation': ''}, {'ForeName': 'Tan', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Cook', 'Affiliation': ''}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Schwebke', 'Affiliation': ''}, {'ForeName': 'Purnima', 'Initials': 'P', 'LastName': 'Madhivanan', 'Affiliation': ''}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000001256']
1704,32741071,Comparing the different oxycodone doses of prevent oxycodone for prevention of preventing fentanyl-induced cough during induction of general anaesthesia.,"BACKGROUND


Fentanyl-induced cough (FIC) usually occurs after the intravenous administration of fentanyl during general anaesthesia induction. It is a transient condition depending on the fentanyl administration dose and injection speed. Oxycodone can also prevent FIC because it has been proven to treat coughing. This study aimed to evaluate the efficacy of different oxycodone doses to prevent FIC during general anaesthesia induction.
METHODS


In a double-blind randomised controlled trial, 210 adult patients who were undergoing elective surgery, classified as American Society of Anaesthesiologists physical status I-II, and aged 20-65 years were randomly assigned into five equally sized groups: Sham group, Group Ⅰ, Group II, Group III and Group IV. Groups Ⅰ-IV were each intravenously injected with oxycodone 0.025, 0.05, 0.075 and 0.100 mg/kg, while an equal volume of normal saline was given instead of oxycodone in the Sham group. Five minutes later, fentanyl 3 μg/kg was intravenously injected within 5 seconds, then, 2 minutes later the other drugs were administered for general anaesthesia induction. The occurrence and severity of coughing were observed within 2 minutes of the fentanyl injection. Vital signs and intensities of coughing were recorded and analysed.
RESULTS


Coughing incidences were each 57.1, 50, 42.8, 33.3 and 21.4% in the Sham group and Groups Ⅰ-IV. Significant differences were found in the incidences of coughing between the Sham group and Groups III-IV. No significant differences in FIC incidences have been detected between the Sham group and Groups Ⅰ-II. However, no significant difference in FIC incidence existed between Group III and Group IV. Cough severities in Groups III and IV were significantly lower than in Groups Ⅰ and II (P < .05). No significant differences existed in the hypotension or severe bradycardia incidences during anaesthesia induction among the five groups (P > .05).
CONCLUSION


Oxycodone 0.075 mg/kg provided more effective FIC prevention during general anaesthesia induction.",2020,No significant differences in FIC incidences have been detected between the Sham group and Groups Ⅰ,"['210 adult patients who were undergoing elective surgery, classified as American Society of Anesthesiologists physical status', 'I ～ II, and aged 20-65 years']","['fentanyl', 'oxycodone', 'Oxycodone']","['incidences of coughing', 'FIC incidences', 'Vital signs and intensities of coughing', 'hypotension or severe bradycardia incidences', 'Cough severities', 'FIC incidence', 'Coughing incidences', 'occurrence and severity of coughing', 'effective FIC prevention']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]",210.0,0.0682328,No significant differences in FIC incidences have been detected between the Sham group and Groups Ⅰ,"[{'ForeName': 'Bizhao', 'Initials': 'B', 'LastName': 'Dai', 'Affiliation': ""Department of Anesthesiology, The Affiliated Xuzhou No. 1 People's Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China.""}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}]",International journal of clinical practice,['10.1111/ijcp.13642']
1705,32741773,Ubiquinol supplementation in elderly patients undergoing aortic valve replacement: biochemical and clinical aspects.,"Epidemiological data show a rise in the mean age of patients affected by heart disease undergoing cardiac surgery. Senescent myocardium reduces the tolerance to ischemic stress and there are indications about age-associated deficit in post-operative cardiac performance. Coenzyme Q10 (CoQ10), and more specifically its reduced form ubiquinol (QH), improve several conditions related to bioenergetic deficit or increased exposure to oxidative stress. This trial (Eudra-CT 2009-015826-13) evaluated the clinical and biochemical effects of ubiquinol in 50 elderly patients affected by severe aortic stenosis undergoing aortic valve replacement and randomized to either placebo or 400 mg/day ubiquinol from 7 days before to 5 days after surgery. Plasma and cardiac tissue CoQ10 levels and oxidative status, circulating troponin I, CK-MB (primary endpoints), IL-6 and S100B were assessed. Moreover, main cardiac adverse effects, NYHA class, contractility and myocardial hypertrophy (secondary endpoints) were evaluated during a 6-month follow-up visit. Ubiquinol treatment counteracted the post-operative plasma CoQ10 decline (p<0.0001) and oxidation (p=0.038) and curbed the post-operative increase in troponin I (QH, 1.90 [1.47-2.48] ng/dL; placebo, 4.03 [2.45-6.63] ng/dL; p=0.007) related to cardiac surgery. Moreover, ubiquinol prevented the adverse outcomes that might have been associated with defective left ventricular ejection fraction recovery in elderly patients.",2020,Ubiquinol treatment counteracted the post-operative plasma CoQ10 decline (p<0.0001) and oxidation (p=0.038) and curbed the post-operative increase in troponin,"['50 elderly patients affected by severe aortic stenosis undergoing aortic valve replacement and randomized to either', 'elderly patients undergoing aortic valve replacement', 'mean age of patients affected by heart disease undergoing cardiac surgery', 'elderly patients']","['Coenzyme Q10 (CoQ10', 'Ubiquinol supplementation', 'placebo or 400 mg/day ubiquinol', 'dL; placebo']","['Plasma and cardiac tissue CoQ10 levels and oxidative status, circulating troponin', 'troponin', 'main cardiac adverse effects, NYHA class, contractility and myocardial hypertrophy (secondary endpoints', 'post-operative plasma CoQ10 decline (p<0.0001) and oxidation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0077656', 'cui_str': 'ubiquinol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1272575', 'cui_str': 'Heart tissue'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C3495916', 'cui_str': 'Myocardial hypertrophy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}]",50.0,0.241265,Ubiquinol treatment counteracted the post-operative plasma CoQ10 decline (p<0.0001) and oxidation (p=0.038) and curbed the post-operative increase in troponin,"[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Orlando', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, Ancona 60100, Italy.'}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Sabbatinelli', 'Affiliation': 'Department of Clinical and Molecular Sciences, DISCLIMO, Università Politecnica delle Marche, Ancona 60100, Italy.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Silvestri', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, Ancona 60100, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Marcheggiani', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, Ancona 60100, Italy.'}, {'ForeName': 'Ilenia', 'Initials': 'I', 'LastName': 'Cirilli', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, Ancona 60100, Italy.'}, {'ForeName': 'Phiwayinkosi Vusi', 'Initials': 'PV', 'LastName': 'Dludla', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, Ancona 60100, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Molardi', 'Affiliation': 'Cardiac Surgery Department, Parma University Hospital, Parma 43126, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Nicolini', 'Affiliation': 'Cardiac Surgery Department, Parma University Hospital, Parma 43126, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Tiano', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, Ancona 60100, Italy.'}]",Aging,['10.18632/aging.103742']
1706,32748504,Acute and chronic effects of resistance training on skeletal muscle markers of mitochondrial remodeling in older adults.,"We investigated the acute and chronic effects of resistance training (RT) on skeletal muscle markers of mitochondrial content and remodeling in older, untrained adults. Sixteen participants (n = 6 males, n = 10 females; age = 59 ± 4 years) completed 10 weeks of full-body RT (2 day/week). Muscle biopsies from the vastus lateralis were obtained prior to RT (Pre), 24 hr following the first training session (Acute), and 72 hr following the last training session (Chronic). Protein levels of mitochondrial electron transport chain complexes I-V (+39 to +180%, p ≤ .020) and markers of mitochondrial fusion Mfn1 (+90%, p = .003), Mfn2 (+110%, p < .001), and Opa1 (+261%, p = .004) increased following chronic RT. Drp1 protein levels also increased (+134%, p = .038), while Fis1 protein levels did not significantly change (-5%, p = .584) following chronic RT. Interestingly, protein markers of mitochondrial biogenesis (i.e., PGC-1α, TFAM, and NRF1) or mitophagy (i.e., Pink1 and Parkin) were not significantly altered (p > .050) after 10 weeks of RT. In summary, chronic RT promoted increases in content of electron transport chain proteins (i.e., increased protein levels of all five OXPHOS complexes) and increase in the levels of proteins related to mitochondrial dynamics (i.e., increase in fusion protein markers) in skeletal muscle of older adults. These results suggest that chronic RT could be a useful strategy to increase mitochondrial protein content in older individuals.",2020,"Drp1 protein levels also increased (+134%, p = .038), while Fis1 protein levels did not significantly change (-5%, p = .584) following chronic RT.","['older individuals', 'older, untrained adults', 'Sixteen participants (n\xa0=\xa06 males, n\xa0=\xa010 females; age\xa0=\xa059\xa0±\xa04\xa0years', 'older adults']","['resistance training (RT', 'resistance training']","['protein markers of mitochondrial biogenesis (i.e., PGC-1α, TFAM, and NRF1) or mitophagy (i.e., Pink1 and Parkin', 'Drp1 protein levels', 'markers of mitochondrial fusion Mfn1', 'Protein levels of mitochondrial electron transport chain complexes I-V ', 'Fis1 protein levels', 'mitochondrial protein content']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3494456', 'cui_str': 'Mitochondrial Biogenesis'}, {'cui': 'C1820119', 'cui_str': 'Mitochondrial Degradation'}, {'cui': 'C1311470', 'cui_str': 'PARK2 protein, human'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C1156067', 'cui_str': 'Mitochondrial Fusion'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0013846', 'cui_str': 'Electron transfer'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0171406', 'cui_str': 'NADH dehydrogenase (ubiquinon)'}, {'cui': 'C0949610', 'cui_str': 'Mitochondrial Protein'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",16.0,0.0315857,"Drp1 protein levels also increased (+134%, p = .038), while Fis1 protein levels did not significantly change (-5%, p = .584) following chronic RT.","[{'ForeName': 'Paulo H C', 'Initials': 'PHC', 'LastName': 'Mesquita', 'Affiliation': 'School of Kinesiology, Auburn University, Auburn, AL, USA.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Lamb', 'Affiliation': 'Department of Nutrition, Dietetics and Hospitality Management, Auburn University, Auburn, AL, USA.'}, {'ForeName': 'Hailey A', 'Initials': 'HA', 'LastName': 'Parry', 'Affiliation': 'School of Kinesiology, Auburn University, Auburn, AL, USA.'}, {'ForeName': 'Johnathon H', 'Initials': 'JH', 'LastName': 'Moore', 'Affiliation': 'School of Kinesiology, Auburn University, Auburn, AL, USA.'}, {'ForeName': 'Morgan A', 'Initials': 'MA', 'LastName': 'Smith', 'Affiliation': 'School of Kinesiology, Auburn University, Auburn, AL, USA.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Vann', 'Affiliation': 'School of Kinesiology, Auburn University, Auburn, AL, USA.'}, {'ForeName': 'Shelby C', 'Initials': 'SC', 'LastName': 'Osburn', 'Affiliation': 'School of Kinesiology, Auburn University, Auburn, AL, USA.'}, {'ForeName': 'Carlton D', 'Initials': 'CD', 'LastName': 'Fox', 'Affiliation': 'School of Kinesiology, Auburn University, Auburn, AL, USA.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Ruple', 'Affiliation': 'School of Kinesiology, Auburn University, Auburn, AL, USA.'}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Huggins', 'Affiliation': 'Department of Nutrition, Dietetics and Hospitality Management, Auburn University, Auburn, AL, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Fruge', 'Affiliation': 'Department of Nutrition, Dietetics and Hospitality Management, Auburn University, Auburn, AL, USA.'}, {'ForeName': 'Kaelin C', 'Initials': 'KC', 'LastName': 'Young', 'Affiliation': 'School of Kinesiology, Auburn University, Auburn, AL, USA.'}, {'ForeName': 'Andreas N', 'Initials': 'AN', 'LastName': 'Kavazis', 'Affiliation': 'School of Kinesiology, Auburn University, Auburn, AL, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Roberts', 'Affiliation': 'School of Kinesiology, Auburn University, Auburn, AL, USA.'}]",Physiological reports,['10.14814/phy2.14526']
1707,32748551,Acute effects of high-intensity interval training session and endurance exercise on pulmonary function and cardiorespiratory coupling.,"The aim of this study was to determine the acute effects of high-intensity interval training (HIIT) exercise and endurance exercise (EE) on pulmonary function, sympathetic/parasympathetic balance, and cardiorespiratory coupling (CRC) in healthy participants. Using a crossover repeated-measurements design, four females and four males were exposed to EE (20 min at 80% maximal heart rate [HR]), HIIT (1 min of exercise at 90% maximal HR per 1 min of rest, 10 times), or control condition (resting). Pulmonary function, HR, CRC, and heart rate variability (HRV) were assessed before and after the interventions. Results revealed no significant effects of EE or HIIT on pulmonary function. The EE, but not HIIT, significantly increased CRC. In contrast, HRV was markedly changed by HIIT, not by EE. Indeed, both the low-frequency (LF HRV  ) and high-frequency (HF HRV  ) components of HRV were increased and decreased, respectively, after HIIT. The increase in LF HRV  was greater after HIIT than after EE. Therefore, a single bout of HIIT or EE has no effects on pulmonary function. Moreover, CRC and cardiac autonomic regulation are targeted differently by the two exercise modalities.",2020,Results revealed no significant effects of EE or HIIT on pulmonary function.,"['healthy participants', 'four females and four males']","['high-intensity interval training session and endurance exercise', 'HIIT (1\xa0min of exercise at 90% maximal HR per 1\xa0min of rest, 10 times), or control condition (resting', 'high-intensity interval training (HIIT) exercise and endurance exercise (EE']","['EE or HIIT on pulmonary function', 'HRV', 'LF HRV', 'CRC', 'low-frequency (LF HRV  ) and high-frequency (HF HRV  ) components of HRV', 'pulmonary function', 'Pulmonary function, HR, CRC, and heart rate variability (HRV', 'pulmonary function, sympathetic/parasympathetic balance, and cardiorespiratory coupling (CRC', 'pulmonary function and cardiorespiratory coupling']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",,0.0230243,Results revealed no significant effects of EE or HIIT on pulmonary function.,"[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Andrade', 'Affiliation': 'Centro de Investigación en Fisiología del Ejercicio, Facultad de Ciencias, Universidad Mayor, Santiago, Chile.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Arce-Alvarez', 'Affiliation': 'Escuela de Kinesiología, Facultad de Salud, Universidad Católica Silva Henríquez, Santiago, Chile.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Parada', 'Affiliation': 'Centro de Investigación en Fisiología del Ejercicio, Facultad de Ciencias, Universidad Mayor, Santiago, Chile.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Uribe', 'Affiliation': 'Centro de Investigación en Fisiología del Ejercicio, Facultad de Ciencias, Universidad Mayor, Santiago, Chile.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Gordillo', 'Affiliation': 'Centro de Investigación en Fisiología del Ejercicio, Facultad de Ciencias, Universidad Mayor, Santiago, Chile.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Dupre', 'Affiliation': 'Centro de Investigación en Fisiología del Ejercicio, Facultad de Ciencias, Universidad Mayor, Santiago, Chile.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Ojeda', 'Affiliation': 'Centro de Investigación en Fisiología del Ejercicio, Facultad de Ciencias, Universidad Mayor, Santiago, Chile.'}, {'ForeName': 'Fiorella', 'Initials': 'F', 'LastName': 'Palumbo', 'Affiliation': 'Centro de Investigación en Fisiología del Ejercicio, Facultad de Ciencias, Universidad Mayor, Santiago, Chile.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Castro', 'Affiliation': 'Centro de Investigación en Fisiología del Ejercicio, Facultad de Ciencias, Universidad Mayor, Santiago, Chile.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Vasquez-Muñoz', 'Affiliation': 'Centro de Investigación en Fisiología del Ejercicio, Facultad de Ciencias, Universidad Mayor, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Del Rio', 'Affiliation': 'Laboratory of Cardiorespiratory Control, Department of Physiology, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ramirez-Campillo', 'Affiliation': 'Centro de Investigación en Fisiología del Ejercicio, Facultad de Ciencias, Universidad Mayor, Santiago, Chile.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IDISNA, Pamplona, Spain.'}]",Physiological reports,['10.14814/phy2.14455']
1708,32745830,A randomised trial comparing a brief online delivery of mindfulness-plus-values versus values only for symptoms of depression: Does baseline severity matter?,"BACKGROUND


Acceptance/mindfulness-based interventions often focus on (a) developing dispositional mindfulness and (b) pursuing personally meaningful and valued activities. Acceptance/mindfulness-based interventions can reduce depression, but little is known about the combined effects of components or the influence of baseline variables on outcomes. This study tested whether practicing a brief (10-min) mindfulness meditation over a 2-week period followed by a single values session (mindfulness+values) was more effective than values alone (values only) in reducing symptoms of depression. The study was delivered online and modules were fully self-help (i.e., no therapist contact).
METHODS


206 participants (M age =23.4 years, SD=6.53) with elevated depression scores (DASS-depression ≥ 10) were randomised to: mindfulness+values condition or a 2-week wait period followed by the values session (i.e., values only condition). Symptoms of depression were assessed at baseline, after the 2-week mindfulness practice/wait period, and 1-week following the values session.
RESULTS


Reductions in depression and recovery rates were significantly greater following mindfulness+values than values only. Baseline severity affected outcomes: mindfulness+values was significantly more beneficial than values only for individuals with high baseline levels of depression. Outcomes did not differ for those with low levels of depression. Rates of deterioration were higher than expected for values only participants.
LIMITATIONS


Conclusions are preliminary and tentative due to no follow-up period and a small sample. Drop-out was high (50%) and findings cannot be assumed to generalise to treatment seeking or more diverse samples.
CONCLUSIONS


Tentatively, results suggest mindfulness+values can significantly reduce depression, especially for individuals with higher baseline depression.",2020,Baseline severity affected outcomes: mindfulness+values was significantly more beneficial than values only for individuals with high baseline levels of depression.,"['206 participants (M age =23.4 years, SD=6.53) with elevated depression scores (DASS-depression ≥ 10']","['mindfulness-plus-values', 'practicing a brief (10-min) mindfulness meditation']","['Symptoms of depression', 'Rates of deterioration', 'depression and recovery rates']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",206.0,0.0678318,Baseline severity affected outcomes: mindfulness+values was significantly more beneficial than values only for individuals with high baseline levels of depression.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kingston', 'Affiliation': 'Royal Holloway University of London Egham Hill Egham, Bowyer Building, Surrey TW20 0EX, United Kingdom. Electronic address: Jessica.kingston@rhul.ac.uk.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Becker', 'Affiliation': 'Royal Holloway University of London Egham Hill Egham, Bowyer Building, Surrey TW20 0EX, United Kingdom.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Woeginger', 'Affiliation': 'Royal Holloway University of London Egham Hill Egham, Bowyer Building, Surrey TW20 0EX, United Kingdom.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ellett', 'Affiliation': 'Royal Holloway University of London Egham Hill Egham, Bowyer Building, Surrey TW20 0EX, United Kingdom.'}]",Journal of affective disorders,['10.1016/j.jad.2020.07.087']
1709,32745891,Automatic Imitation in Comorbid PTSD & Alcohol Use Disorder and Controls: an RCT of Intranasal Oxytocin.,"INTRODUCTION


Mimicking movements of others makes both the imitating and imitated partners feel closer. Oxytocin may increase focus on others and has been shown to increase automatic imitation in healthy controls (HC). However, this has not been replicated, and oxytocin's effects on automatic imitation have not been demonstrated in clinical populations. This study attempts to replicate effects on HC and examine effects on people with comorbid posttraumatic stress disorder and alcohol use disorder (PTSD-AUD).
METHODS


Fifty-four males with PTSD-AUD and 43 male HC received three intranasal treatment conditions (placebo, oxytocin 20 International Units (IU), and oxytocin 40 IU) in a randomized order, across three separate testing days, as part of a double-blind, crossover parent study. At 135 min post-administration, each performed the imitation-inhibition task, which quantifies automatic imitation as the congruency effect (CE). After exclusions, the final analyzed data set included 49 participants with PTSD-AUD and 38 HC.
RESULTS


In HC, oxytocin 20 IU demonstrated a statistically significant increase in CE, and 40 IU showed a trend-level increase. In PTSD-AUD, oxytocin did not significantly increase CE. Post-hoc analysis showed the PTSD-AUD group had higher CE than HC on placebo visits.
DISCUSSION


Our data suggest PTSD-AUD is associated with higher automatic imitation than HC in the absence of oxytocin administration. We successfully replicated findings that oxytocin increases automatic imitation in HC. This demonstrates an unconscious motor effect induced by oxytocin, likely relevant to more complex forms of imitative movements, which have the potential to improve social connection. We did not find a significant effect of oxytocin on automatic imitation in PTSD-AUD. Future research should examine imitation in both sexes, at peak oxytocin levels, and on increasingly complex forms of imitation.",2020,"In HC, oxytocin 20 IU demonstrated a statistically significant increase in CE, and 40 IU showed a trend-level increase.","['49 participants with PTSD-AUD and 38 HC', 'Fifty-four males with PTSD-AUD and 43 male HC', 'people with comorbid posttraumatic stress disorder and alcohol use disorder (PTSD-AUD', 'healthy controls (HC']","['intranasal treatment conditions (placebo, oxytocin 20 International Units (IU), and oxytocin 40 IU', 'oxytocin', 'Intranasal Oxytocin', 'Oxytocin']","['CE', 'automatic imitation']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0439453', 'cui_str': 'IU'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205554', 'cui_str': 'Automated'}]",49.0,0.0522705,"In HC, oxytocin 20 IU demonstrated a statistically significant increase in CE, and 40 IU showed a trend-level increase.","[{'ForeName': 'Tyler E', 'Initials': 'TE', 'LastName': 'Morrison', 'Affiliation': 'Department of Psychiatry at University of California San Francisco School of Medicine, 401 Parnassus Ave (Box 0984 RTP), San Francisco, CA, 94143, USA. Electronic address: morrisont@gmail.com.'}, {'ForeName': 'Lize', 'Initials': 'L', 'LastName': 'De Coster', 'Affiliation': 'Department of Psychiatry at University of California San Francisco School of Medicine, 401 Parnassus Ave (Box 0984 RTP), San Francisco, CA, 94143, USA; VA San Francisco Healthcare System, 4150 Clement St (116C-1), San Francisco, CA, 94121, USA. Electronic address: lize.decoster@gmail.com.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Stauffer', 'Affiliation': 'VA San Francisco Healthcare System, 4150 Clement St (116C-1), San Francisco, CA, 94121, USA. Electronic address: Christopher.Stauffer@ucsf.edu.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wen', 'Affiliation': 'VA San Francisco Healthcare System, 4150 Clement St (116C-1), San Francisco, CA, 94121, USA. Electronic address: jin.wen2100@gmail.com.'}, {'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Ahmadi', 'Affiliation': 'VA San Francisco Healthcare System, 4150 Clement St (116C-1), San Francisco, CA, 94121, USA. Electronic address: elnaz.ahmadi@gmail.com.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Delucchi', 'Affiliation': 'Department of Psychiatry at University of California San Francisco School of Medicine, 401 Parnassus Ave (Box 0984 RTP), San Francisco, CA, 94143, USA. Electronic address: Kevin.Delucchi@ucsf.edu.'}, {'ForeName': 'Aoife', 'Initials': 'A', 'LastName': ""O'Donovan"", 'Affiliation': 'Department of Psychiatry at University of California San Francisco School of Medicine, 401 Parnassus Ave (Box 0984 RTP), San Francisco, CA, 94143, USA; VA San Francisco Healthcare System, 4150 Clement St (116C-1), San Francisco, CA, 94121, USA. Electronic address: Aoife.ODonovan@ucsf.edu.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Woolley', 'Affiliation': 'Department of Psychiatry at University of California San Francisco School of Medicine, 401 Parnassus Ave (Box 0984 RTP), San Francisco, CA, 94143, USA; VA San Francisco Healthcare System, 4150 Clement St (116C-1), San Francisco, CA, 94121, USA. Electronic address: Josh.Woolley@ucsf.edu.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104787']
1710,32745945,"Chasing the desire: An investigation on the role of craving, time perspective, and alcohol use in adolescent gambling.","Chasing, or continuing to gamble to recoup losses, is a behavioral marker and a diagnostic criterion for gambling disorder. Research on chasing has focused mainly on adults, whereas the analysis of chasing behavior among adolescents has not received empirical attention in the gambling literature. The aim of the present study was to first investigate the interplay between chasing behavior, craving, temporal perspective, alcohol use, and gambling severity among Italian adolescents. Three hundred and sixty-four adolescents took part in the study. Participants completed the South Oaks Gambling Screen Revised for Adolescents (SOGS-RA), the Gambling Craving Scale (GACS), the 14-item Consideration of Future Consequences scale (CFC-14), the Alcohol Use Disorders Identification Test (AUDIT), and performed a computerized task assessing chasing behavior. Participants were randomly assigned to the control and the loss condition of the computerized task. Results indicated that the choice to continue playing, as well as chasing frequency did not vary as a function of experimental condition. Hierarchical logistic and linear regression analyses revealed that the decision to chase depended mostly on craving, whereas chasing propensity was affected by craving and alcohol misuse. Notably, gambling severity did not predict either the decision to chase, or the chasing persistence. The present study contributes important findings to the gambling literature, highlighting the role of craving alcohol use in facilitating the inability to stop within-sessions gambling among adolescents. These findings may provide evidence that nonchasers and chasers represent two different types of gamblers, and that the difference may be useful for targeting more effective therapies.",2020,"Participants completed the South Oaks Gambling Screen Revised for Adolescents (SOGS-RA), the Gambling Craving Scale (GACS), the 14-item Consideration of Future Consequences scale (CFC-14), the Alcohol Use Disorders Identification Test (AUDIT), and performed a computerized task assessing chasing behavior.","['Chasing the desire', 'Three hundred and sixty-four adolescents took part in the study', 'Italian adolescents', 'adolescent gambling']",[],"['South Oaks Gambling Screen Revised for Adolescents (SOGS-RA), the Gambling Craving Scale (GACS']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}]",[],"[{'cui': 'C0330302', 'cui_str': 'Genus Quercus'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",364.0,0.0202985,"Participants completed the South Oaks Gambling Screen Revised for Adolescents (SOGS-RA), the Gambling Craving Scale (GACS), the 14-item Consideration of Future Consequences scale (CFC-14), the Alcohol Use Disorders Identification Test (AUDIT), and performed a computerized task assessing chasing behavior.","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Cosenza', 'Affiliation': 'Department of Psychology, Università degli studi della Campania ""Luigi Vanvitelli"", Viale Ellittico, 31, 81100 Caserta, Italy. Electronic address: marina.cosenza@unicampania.it.'}, {'ForeName': 'Olimpia', 'Initials': 'O', 'LastName': 'Matarazzo', 'Affiliation': 'Department of Psychology, Università degli studi della Campania ""Luigi Vanvitelli"", Viale Ellittico, 31, 81100 Caserta, Italy. Electronic address: olimpia.matarazzo@unicampania.it.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ciccarelli', 'Affiliation': 'Department of Psychology, Università degli studi della Campania ""Luigi Vanvitelli"", Viale Ellittico, 31, 81100 Caserta, Italy. Electronic address: maria.ciccarelli@unicampania.it.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Nigro', 'Affiliation': 'Department of Psychology, Università degli studi della Campania ""Luigi Vanvitelli"", Viale Ellittico, 31, 81100 Caserta, Italy. Electronic address: giovanna.nigro@unicampania.it.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106566']
1711,32745964,"Impact of sex and age on chemotherapy efficacy, toxicity and survival in localised oesophagogastric cancer: A pooled analysis of 3265 individual patient data from four large randomised trials (OE02, OE05, MAGIC and ST03).","BACKGROUND


There is a lack of large-scale randomised data evaluating the impact of sex and age in patients undergoing chemotherapy followed by potentially curative surgery for oesophagogastric cancer.
PATIENTS AND METHODS


Individual patient data from four prospective randomised controlled trials were pooled using a two-stage meta-analysis. For survival analysis, hazard ratios (HRs) were calculated for patients aged <70 and ≥ 70 years, as well as between males and females. Mandard tumour regression grade (TRG) and, ≥grade III toxicities were compared using logistic regression models to calculate odds ratios. All analyses were adjusted for the type of chemotherapy received.
RESULTS


3265 patients were included for survival analysis (2668 [82%] male, 597 [18%] female; 2627 (80%) <70 years, 638 (20%) ≥70 years). A significant improvement in overall survival (OS) (HR: 0.78; p < 0.001) and disease-specific survival (DSS) (HR: 0.78; p < 0.001) was observed in females compared with males. No significant differences in OS (HR: 1.11; p = 0.045) or DSS (HR: 1.01; p = 0.821) were observed in older patients compared with younger patients. For patients who underwent resection, older patients (15% vs 10%; p = 0.03) and female patients (14% vs 10%, p = 0.10) were more likely to achieve favourable Mandard TRG scores. Females experienced significantly more ≥grade III nausea (10% vs 5%; p≤0.001), vomiting (10% vs 4%; p≤0.001) and diarrhoea (9% vs 4%; p≤0.001) than males.
CONCLUSIONS


In this large pooled analysis using prospective randomised trial data, females had significantly improved survival while experiencing more gastrointestinal toxicities. Older patients achieved comparable survival to younger patients and thus, dependent on fitness, should be offered the same treatment paradigm.",2020,A significant improvement in overall survival (OS) (HR: 0.78; p < 0.001) and disease-specific survival (DSS) (HR: 0.78; p < 0.001) was observed in females compared with males.,"['Older patients', '3265 individual patient data from four large randomised trials (OE02, OE05, MAGIC and ST03', 'localised oesophagogastric cancer', 'patients undergoing chemotherapy followed by potentially curative surgery for oesophagogastric cancer', '3265 patients were included for survival analysis (2668 [82%] male, 597 [18%] female; 2627 (80%) <70 years, 638 (20%) ≥70 years']",[],"['chemotherapy efficacy, toxicity and survival', '≥grade III nausea', 'Mandard tumour regression grade (TRG) and, ≥grade III toxicities', 'favourable Mandard TRG scores', 'diarrhoea', 'survival', 'gastrointestinal toxicities', 'vomiting', 'disease-specific survival (DSS', 'overall survival (OS', 'For survival analysis, hazard ratios (HRs']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0024460', 'cui_str': 'Magic'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",3265.0,0.254262,A significant improvement in overall survival (OS) (HR: 0.78; p < 0.001) and disease-specific survival (DSS) (HR: 0.78; p < 0.001) was observed in females compared with males.,"[{'ForeName': 'Avani', 'Initials': 'A', 'LastName': 'Athauda', 'Affiliation': 'Gastrointestinal and Lymphoma Unit, The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Nankivell', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, 90 High Holborn, Second Floor, London, WC1V 6LJ, United Kingdom.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Langley', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, 90 High Holborn, Second Floor, London, WC1V 6LJ, United Kingdom.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Alderson', 'Affiliation': 'Department of Surgery, Queen Elizabeth Hospital, Mindelsohn Way, Edgbaston, Birmingham, B15 2WB, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Allum', 'Affiliation': 'Gastrointestinal and Lymphoma Unit, The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, United Kingdom.'}, {'ForeName': 'Heike I', 'Initials': 'HI', 'LastName': 'Grabsch', 'Affiliation': ""Department of Pathology, GROW School for Oncology and Developmental Biology, Maastricht University Medical Center+, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands; Pathology and Data Analytics, Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, LS9 7TF, United Kingdom.""}, {'ForeName': 'Naureen', 'Initials': 'N', 'LastName': 'Starling', 'Affiliation': 'Gastrointestinal and Lymphoma Unit, The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, United Kingdom.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Chau', 'Affiliation': 'Gastrointestinal and Lymphoma Unit, The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Gastrointestinal and Lymphoma Unit, The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, United Kingdom. Electronic address: david.cunningham@rmh.nhs.uk.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.06.005']
1712,32765052,Modified Pectoral Nerve Block versus Serratus Block for Analgesia Following Modified Radical Mastectomy: A Randomized Controlled Trial.,"Background


Modified pectoral nerves (PECSII) and serratus blocks have been recently used for analgesia in breast surgery, but evidence comparing their analgesic benefits is limited. This prospective randomized, controlled study aims to examine the analgesic efficacy and safety profile of ultrasound-guided PECSII versus serratus blocks in patients undergoing modified radical mastectomy (MRM) for breast cancer.
Patients and Methods


One-hundred and eighty adult females scheduled for MRM were randomly allocated to three groups. PECS group patients received a PECSII block with 30mL of bupivacaine 0.25%, whereas SAPB group received a serratus anterior plane block (SAPB) using the same volume of bupivacaine 0.25% before induction of anesthesia. The control group received general anesthesia alone. Outcomes included 24 hours morphine consumption, intraoperative fentanyl requirements, visual analogue scale (VAS) scores for pain at rest and during movement, time to first rescue analgesia, postoperative nausea and vomiting (PONV), and sedation scores.
Results


Both PECSII and serratus blocks were associated with reduced postoperative morphine consumption compared to the control group (p<0.001). Both blocks were associated with reduced intraoperative fentanyl requirements, VAS scores, and PONV as compared with the control group. Also, they were associated with prolonged time to first rescue analgesia and better sedation scores in comparison with the control group. However, there were no differences between both blocks for all outcomes.
Conclusion


PECSII and serratus blocks provide similarly adequate analgesia following modified radical mastectomy.
Clinical Trial Registration


NCT02946294.",2020,"Both blocks were associated with reduced intraoperative fentanyl requirements, VAS scores, and PONV as compared with the control group.","['patients undergoing modified radical mastectomy (MRM) for breast cancer', 'Patients and Methods\n\n\nOne-hundred and eighty adult females scheduled for MRM']","['general anesthesia alone', 'bupivacaine', 'PECSII block with 30mL of bupivacaine', 'ultrasound-guided PECSII versus serratus blocks', '\n\n\nModified pectoral nerves (PECSII) and serratus blocks', 'PECS', 'Modified Pectoral Nerve Block versus Serratus Block for Analgesia Following Modified Radical Mastectomy', 'serratus anterior plane block (SAPB', 'SAPB']","['analgesic efficacy and safety profile', 'prolonged time to first rescue analgesia and better sedation scores', '24 hours morphine consumption, intraoperative fentanyl requirements, visual analogue scale (VAS) scores for pain at rest and during movement, time to first rescue analgesia, postoperative nausea and vomiting (PONV), and sedation scores', 'postoperative morphine consumption', 'intraoperative fentanyl requirements, VAS scores, and PONV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205967', 'cui_str': 'Pectoral Nerves'}, {'cui': 'C0055065', 'cui_str': 'CEP combination'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",180.0,0.157085,"Both blocks were associated with reduced intraoperative fentanyl requirements, VAS scores, and PONV as compared with the control group.","[{'ForeName': 'Ahmed H', 'Initials': 'AH', 'LastName': 'Bakeer', 'Affiliation': 'Department of Anesthesia and Pain Management, National Cancer Institute, Cairo, Egypt.'}, {'ForeName': 'Khaled M', 'Initials': 'KM', 'LastName': 'Kamel', 'Affiliation': 'Department of Anesthesia and Pain Management, National Cancer Institute, Cairo, Egypt.'}, {'ForeName': 'Ahmed S', 'Initials': 'AS', 'LastName': 'Abdelgalil', 'Affiliation': 'Department of Anesthesia and Pain Management, National Cancer Institute, Cairo, Egypt.'}, {'ForeName': 'Ayman A', 'Initials': 'AA', 'LastName': 'Ghoneim', 'Affiliation': 'Department of Anesthesia and Pain Management, National Cancer Institute, Cairo, Egypt.'}, {'ForeName': 'Ahmed H', 'Initials': 'AH', 'LastName': 'Abouel Soud', 'Affiliation': 'Department of Anesthesia and Pain Management, National Cancer Institute, Cairo, Egypt.'}, {'ForeName': 'Mohamed E', 'Initials': 'ME', 'LastName': 'Hassan', 'Affiliation': 'Department of Anesthesia and Pain Management, National Cancer Institute, Cairo, Egypt.'}]",Journal of pain research,['10.2147/JPR.S252539']
1713,32765053,"Efficacy, Practicality, and Safety of Inhaled Methoxyflurane in Elderly Patients with Acute Trauma Pain: Subgroup Analysis of a Randomized, Controlled, Multicenter, Open-Label Trial (MEDITA).","Purpose


Acute trauma pain management in the elderly population is a challenge. Inhaled methoxyflurane represents a promising treatment option; however, data in the elderly population are limited.
Patients and Methods


Subgroup, post hoc analysis including 69 patients aged ≥65 years from a randomized, active-controlled, open-label study in the emergency setting. Key inclusion criterion was moderate-to-severe pain (Numerical Rating Scale [NRS] score ≥ 4]) secondary to trauma in a single limb. Patients received inhaled methoxyflurane (3 mL) or standard analgesic treatment (SAT; IV paracetamol 1 g or ketoprofen 100 mg for moderate pain [NRS 4-6] and IV morphine 0.1mg/kg for severe pain [NRS ≥7]). The primary endpoint was the overall change in visual analog scale (VAS) pain intensity from randomization to the next 3, 5, and 10 min. Secondary endpoints included time to onset of pain relief (TOPR), efficacy up to 30 min, judgment of operators and patients, and safety.
Results


Pain reduction over time was similar in both groups. Median TOPR was shorter for methoxyflurane (9 min; 95% CI: 7.8, 10.2 min) than SAT (15 min; 95% CI: 10.2, 19.8 min). In terms of treatment satisfaction, patients and operators rated treatment efficacy and practicality, respectively, as ""Excellent"" or ""Very good"" 5.7 times and 3.4 times more frequently than SAT. A similar rate of adverse events (methoxyflurane: 6 events; SAT: 7 events) was recorded, all non-serious. No clinically significant changes in vital signs parameters were observed, and methoxyflurane did not result in cases of bradycardia or hypotension.
Conclusion


In elderly patients with trauma pain, inhaled methoxyflurane shows similar pain relief and safety compared to SAT, offering advantages in terms of onset of effect and user's satisfaction. Although this analysis presents some methodological limitations, it provides the first specific evidence of the use of inhaled methoxyflurane in the elderly population.
Trial Registration


EudraCT number: 2017-001565-25; Clinicaltrials.gov identifier NCT03585374.",2020,"Median TOPR was shorter for methoxyflurane (9 min; 95% CI: 7.8, 10.2 min) than SAT (15 min; 95% CI: 10.2, 19.8 min).","['69 patients aged ≥65 years from a randomized, active-controlled, open-label study in the emergency setting', 'elderly patients with trauma pain', 'Elderly Patients with Acute Trauma Pain', 'EudraCT number']","['Inhaled methoxyflurane', 'inhaled methoxyflurane', 'Inhaled Methoxyflurane', 'methoxyflurane', 'inhaled methoxyflurane (3 mL) or standard analgesic treatment (SAT; IV paracetamol 1 g or ketoprofen', 'morphine']","['Efficacy, Practicality, and Safety', 'time to onset of pain relief (TOPR), efficacy up to 30 min, judgment of operators and patients, and safety', 'Median TOPR', 'overall change in visual analog scale (VAS) pain intensity', 'vital signs parameters', 'pain relief and safety', 'bradycardia or hypotension', 'Pain reduction', 'moderate-to-severe pain (Numerical Rating Scale [NRS] score ≥ 4]) secondary to trauma in a single limb']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0025688', 'cui_str': 'Methoxyflurane'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}]",69.0,0.213658,"Median TOPR was shorter for methoxyflurane (9 min; 95% CI: 7.8, 10.2 min) than SAT (15 min; 95% CI: 10.2, 19.8 min).","[{'ForeName': 'Sossio', 'Initials': 'S', 'LastName': 'Serra', 'Affiliation': 'Emergency Department, Maurizio Bufalini Hospital, Cesena, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Voza', 'Affiliation': 'Emergency Department, IRCCS Humanitas Research Teaching Hospital, Rozzano, Milan, Italy.'}, {'ForeName': 'Germana', 'Initials': 'G', 'LastName': 'Ruggiano', 'Affiliation': 'Emergency Medicine Department, Santa Maria Annunziata Hospital, Florence, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fabbri', 'Affiliation': 'Department of Emergency Medicine, Morgagni-Pierantoni Hospital, Forlì, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Bonafede', 'Affiliation': 'YGHEA, CRO Division of Ecol Studio Bioikos S.r.l., Bologna, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Sblendido', 'Affiliation': 'Medical Affairs Department, Mundipharma Pharmaceuticals Srl, Milan, Italy.'}, {'ForeName': 'Amedeo', 'Initials': 'A', 'LastName': 'Soldi', 'Affiliation': 'Medical Affairs Department, Mundipharma Pharmaceuticals Srl, Milan, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Farina', 'Affiliation': 'Medical Affairs Department, Mundipharma Pharmaceuticals Srl, Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of pain research,['10.2147/JPR.S255532']
1714,32765057,"Digital Treatment of Back Pain versus Standard of Care: The Cluster-Randomized Controlled Trial, Rise-uP.","Purpose


Non-specific low back pain (NLBP) causes an enormous burden to patients and tremendous costs for health care systems worldwide. Frequently, treatments are not oriented to existing guidelines. In the future, digital elements may be promising tools to support guideline-oriented treatment in a broader range of patients. The cluster-randomized controlled ""Rise-uP"" trial aims to support a General Practitioner (GP)-centered back pain treatment (Registration No: DRKS00015048) and includes the following digital elements: 1) electronic case report form (eCRF), 2) a treatment algorithm for guideline-based clinical decision making of GPs, 3) teleconsultation between GPs and pain specialists for patients at risk for development of chronic back pain, and 4) a multidisciplinary mobile back pain app for all patients (Kaia App).
Methods


In the Rise-uP trial, 111 GPs throughout Bavaria (southern Germany) were randomized either to the Rise-uP intervention group (IG) or the control group (CG). Rise-uP patients were treated according to the guideline-oriented Rise-uP treatment algorithm. Standard of care was applied to the CG patients with consideration given to the ""National guideline for the treatment of non-specific back pain"". Pain rating on the numeric rating scale was the primary outcome measure. Psychological measures (anxiety, depression, stress), functional ability, as well as physical and mental wellbeing, served as secondary outcomes. All values were assessed at the beginning of the treatment and at 3-month follow-ups.
Results


In total, 1245 patients (IG: 933; CG: 312) with NLBP were included in the study. The Rise-uP group showed a significantly stronger pain reduction compared to the control group after 3 months (IG: M=-33.3% vs CG: M=-14.3%). The Rise-uP group was also superior in secondary outcomes. Furthermore, high-risk patients who received a teleconsultation showed a larger decrease in pain intensity (-43.5%) than CG patients (-14.3%). ANCOVA analysis showed that the impact of teleconsultation was mediated by an increased training activity in the Kaia App.
Conclusion


Our results show the superiority of the innovative digital treatment algorithm realized in Rise-uP, even though the CG also received relevant active treatment by their GPs. This provides clear evidence that digital treatment may be a promising tool to improve the quality of treatment of non-specific back pain. In 2021, analyses of routine data from statutory health insurances will enable us to investigate the cost-effectiveness of digital treatment.",2020,The Rise-uP group showed a significantly stronger pain reduction compared to the control group after 3 months (IG: M=-33.3% vs CG:,"['patients at risk for development of chronic back pain, and 4) a multidisciplinary mobile back pain app for all patients (Kaia App', '1245 patients (IG: 933; CG: 312) with NLBP were included in the study', '111 GPs throughout Bavaria (southern Germany']","['electronic case report form (eCRF), 2) a treatment algorithm for guideline-based clinical decision making of GPs, 3) teleconsultation between GPs and pain specialists', 'Digital Treatment of Back Pain versus Standard of Care', 'CG']","['Pain rating', 'pain reduction', 'pain intensity', 'numeric rating scale', 'Psychological measures (anxiety, depression, stress), functional ability, as well as physical and mental wellbeing, served as secondary outcomes', 'training activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C5191368', 'cui_str': '933'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C4551412', 'cui_str': 'Electronic case report form'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4042877', 'cui_str': 'Medical Decision-Making'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C0282675', 'cui_str': 'Teleconsultation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040606', 'cui_str': 'Training Activities'}]",1245.0,0.0600738,The Rise-uP group showed a significantly stronger pain reduction compared to the control group after 3 months (IG: M=-33.3% vs CG:,"[{'ForeName': 'Janosch A', 'Initials': 'JA', 'LastName': 'Priebe', 'Affiliation': 'Center of Interdisciplinary Pain Medicine, Department of Neurology, Klinikum Rechts der Isar, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Katharina K', 'Initials': 'KK', 'LastName': 'Haas', 'Affiliation': 'Center of Interdisciplinary Pain Medicine, Department of Neurology, Klinikum Rechts der Isar, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Leida F', 'Initials': 'LF', 'LastName': 'Moreno Sanchez', 'Affiliation': 'Center of Interdisciplinary Pain Medicine, Department of Neurology, Klinikum Rechts der Isar, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Schoefmann', 'Affiliation': 'Center of Interdisciplinary Pain Medicine, Department of Neurology, Klinikum Rechts der Isar, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Utpadel-Fischler', 'Affiliation': 'Center of Interdisciplinary Pain Medicine, Department of Neurology, Klinikum Rechts der Isar, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Stockert', 'Affiliation': 'Center of Interdisciplinary Pain Medicine, Department of Neurology, Klinikum Rechts der Isar, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Thoma', 'Affiliation': 'Pain Clinic, Algesiologikum Pain Center, Munich, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Schiessl', 'Affiliation': 'Pain Clinic, Algesiologikum Pain Center, Munich, Germany.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Kerkemeyer', 'Affiliation': 'Institute for Applied Health Services Research, inav GmbH, Berlin, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Amelung', 'Affiliation': 'Institute for Applied Health Services Research, inav GmbH, Berlin, Germany.'}, {'ForeName': 'Siegfried', 'Initials': 'S', 'LastName': 'Jedamzik', 'Affiliation': 'Bayerische TelemedAllianz (BTA), Ingolstadt, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Reichmann', 'Affiliation': 'StatConsult GmbH Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Marschall', 'Affiliation': 'Barmer Hauptverwaltung, Wuppertal, Germany.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Toelle', 'Affiliation': 'Center of Interdisciplinary Pain Medicine, Department of Neurology, Klinikum Rechts der Isar, Technical University of Munich, Munich, Germany.'}]",Journal of pain research,['10.2147/JPR.S260761']
1715,32765070,Darolutamide: An Evidenced-Based Review of Its Efficacy and Safety in the Treatment of Prostate Cancer.,"Men treated with androgen deprivation therapy for rising PSA after failed local therapy will often develop castrate resistance, and the appearance of metastases predicts a poor prognosis. Thus, researchers have long sought to prolong the onset of metastasis in patients with nonmetastatic castration-resistant prostate cancer (CRPC). Until 2018, patients in this group had no FDA-approved treatment options. They were typically managed with androgen-deprivation therapy (ADT) to maintain castrate systemic testosterone levels and given approved therapies for metastatic CRPC once metastases appeared. However, third-generation androgen receptor inhibitors (ARIs) have dramatically changed the treatment paradigm, having shown the ability to extend metastasis-free survival (MFS) significantly over ADT alone in Phase 3 trials. The newest of these, darolutamide, prolonged MFS 22 months over placebo while also improving a host of secondary and exploratory endpoints such as overall survival (OS), prostate-specific antigen (PSA) progression and time to pain progression, chemotherapy initiation, and symptomatic skeletal events. Among third-generation ARIs, darolutamide is unique in that it incorporates two pharmacologically active diastereomers and has demonstrated resistance to all known androgen receptor (AR) mutations. Additionally, patients taking darolutamide appear to experience comparatively few central nervous system-related adverse events (AEs) such as fatigue and falls, and no increases in seizures have been reported in the drug's clinical or preclinical development. Various authors attribute the low incidence of CNS-related AEs to darolutamide's minimal penetration of the blood-brain barrier (BBB). Other side effects ranging from hot flashes to hypothyroidism also occurred at rates similar to those of the placebo arm in Phase 3. As ADT in itself raises cardiovascular risk, the cardiovascular safety of third-generation antiandrogens as a category warrants continued scrutiny. In total, however, published data suggest that darolutamide provides a reasonable option for patients with nonmetastatic CRPC. Ongoing research will determine darolutamide's potential role in additional disease states such as localized and castration-sensitive PCa.",2020,Other side effects ranging from hot flashes to hypothyroidism also occurred at rates similar to those of the placebo arm in Phase 3.,"['patients with nonmetastatic castration-resistant prostate cancer (CRPC', 'Prostate Cancer', 'patients with nonmetastatic CRPC']","['androgen deprivation therapy', 'Darolutamide', 'darolutamide', 'androgen-deprivation therapy (ADT', 'placebo']","['overall survival (OS), prostate-specific antigen (PSA) progression and time to pain progression, chemotherapy initiation, and symptomatic skeletal events', 'blood-brain barrier (BBB']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C4547776', 'cui_str': 'darolutamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0005854', 'cui_str': 'Brain-Blood Barrier'}]",,0.0766034,Other side effects ranging from hot flashes to hypothyroidism also occurred at rates similar to those of the placebo arm in Phase 3.,"[{'ForeName': 'E David', 'Initials': 'ED', 'LastName': 'Crawford', 'Affiliation': 'Department of Urology, University of California at San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Stanton', 'Affiliation': 'Department of Pathology, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Divneet', 'Initials': 'D', 'LastName': 'Mandair', 'Affiliation': 'Department of Pathology, University of Colorado School of Medicine, Aurora, CO, USA.'}]",Cancer management and research,['10.2147/CMAR.S227583']
1716,32765189,The effect of a new perioperative practice model on length of hospital stay and on the surgical care process in patients undergoing hip and knee arthroplasty under spinal anesthesia: a randomized clinical trial.,"Background


The shortened length of hospital stays (LOS) requires efficient and patient-participatory perioperative nursing approaches to enable early and safe discharge from hospitals for patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA). The primary aim of this study was to explore the effect comparative to standard perioperative care of a new perioperative practice model (NPPM) on the LOS and the time points of the surgical care process in patients undergoing THA and TKA under spinal anesthesia. The secondary aim was to find out if any subgroups with different response could be found.
Methods


Patients scheduled for elective, primary THA and TKA were assessed for eligibility. A two-group parallel randomized clinical trial was conducted with an intervention group ( n  = 230) and control group ( n  = 220), totaling 450 patients. The patients in the intervention group were each designated with one named anesthesia nurse, who took care of the patient during the entire perioperative process and visited the patient postoperatively. The patients in the control group received standard perioperative care from different nurses during their perioperative processes and without postoperative visits. The surgical care process time points for each study patient were gathered from the operating room management software and hospital information system until hospital discharge.
Results


We did not find any statistically significant differences between the intervention and control groups regarding to LOS. Only slight differences in the time points of the surgical care process could be detected. The subgroup examination revealed that higher age, type of arthroplasty and ASA score 3-4 all separately caused prolonged LOS.
Conclusion


We did not find the new perioperative practice model to shorten either length of hospital stays or the surgical care process in patients undergoing THA and TKA. Further studies at the subgroup level (gender, old age, and ASA score 3 and 4) are needed to recognize the patients who might benefit most from the NPPM.
Trial registration


This study was registered in NIH Clinical.Trials.gov under registration number NCT02906033, retrospectively registered September 19, 2016.",2020,We did not find the new perioperative practice model to shorten either length of hospital stays or the surgical care process in patients undergoing THA and TKA.,"['patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA', 'patients undergoing THA and TKA under spinal anesthesia', 'patients undergoing hip and knee arthroplasty under spinal anesthesia', 'patients undergoing THA and TKA']","['standard perioperative care', 'new perioperative practice model (NPPM']","['length of hospital stay', 'shortened length of hospital stays (LOS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150706', 'cui_str': 'Perioperative care'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}]",,0.0887022,We did not find the new perioperative practice model to shorten either length of hospital stays or the surgical care process in patients undergoing THA and TKA.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pulkkinen', 'Affiliation': 'University of Helsinki, Helsinki University Hospital, Perioperative, Intensive Care and Pain Medicine, PO. Box. 900, Vantaa, FI00029 Helsinki, HUS Finland.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Jousela', 'Affiliation': 'University of Helsinki, Helsinki University Hospital, Perioperative, Intensive Care and Pain Medicine, PO. Box. 900, Vantaa, FI00029 Helsinki, HUS Finland.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Engblom', 'Affiliation': 'Department of Mathematics and Statistics, University of Turku, Turku, Finland.'}, {'ForeName': 'Sanna', 'Initials': 'S', 'LastName': 'Salanterä', 'Affiliation': 'Department of Nursing Science, University of Turku, Joukahaisenkatu 3-5, 20520 Turku, Finland.'}, {'ForeName': 'Kristiina', 'Initials': 'K', 'LastName': 'Junttila', 'Affiliation': 'Department of Nursing Science, University of Turku, Joukahaisenkatu 3-5, 20520 Turku, Finland.'}]",BMC nursing,['10.1186/s12912-020-00465-3']
1717,32765274,"No Statistically Apparent Difference in Antiviral Effectiveness Observed Among Ribavirin Plus Interferon-Alpha, Lopinavir/Ritonavir Plus Interferon-Alpha, and Ribavirin Plus Lopinavir/Ritonavir Plus Interferon-Alpha in Patients With Mild to Moderate Coronavirus Disease 2019: Results of a Randomized, Open-Labeled Prospective Study.","Background


Currently, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread globally, causing an unprecedented pandemic. However, there is no specific antiviral therapy for coronavirus disease 2019 (COVID-19). We conducted a clinical trial to compare the effectiveness of three antiviral treatment regimens in patients with mild to moderate COVID-19.
Methods


This was a single-center, randomized, open-labeled, prospective clinical trial. Eligible patients with mild to moderate COVID-19 were randomized into three groups: ribavirin (RBV) plus interferon-α (IFN-α), lopinavir/ritonavir (LPV/r) plus IFN-α, and RBV plus LPV/r plus IFN-α at a 1:1:1 ratio. Each patient was invited to participate in a 28-d follow-up after initiation of an antiviral regimen. The outcomes include the difference in median interval to SARS-CoV-2 nucleic acid negativity, the proportion of patients with SARS-CoV-2 nucleic acid negativity at day 14, the mortality at day 28, the proportion of patients re-classified as severe cases, and adverse events during the study period.
Results


In total, we enrolled 101 patients in this study. Baseline clinical and laboratory characteristics of patients were comparable among the three groups. In the analysis of intention-to-treat data, the median interval from baseline to SARS-CoV-2 nucleic acid negativity was 12 d in the LPV/r+IFN-α-treated group, as compared with 13 and 15 d in the RBV+IFN-α-treated group and in the RBV+LPV/r+ IFN-α-treated group, respectively ( p =0.23). The proportion of patients with SARS-CoV-2 nucleic acid negativity in the LPV/r+IFN-α-treated group (61.1%) was higher than the RBV+ IFN-α-treated group (51.5%) and the RBV+LPV/r+IFN-α-treated group (46.9%) at day 14; however, the difference between these groups was calculated to be statistically insignificant. The RBV+LPV/r+IFN-α-treated group developed a significantly higher incidence of gastrointestinal adverse events than the LPV/r+ IFN-α-treated group and the RBV+ IFN-α-treated group.
Conclusions


Our results indicate that there are no significant differences among the three regimens in terms of antiviral effectiveness in patients with mild to moderate COVID-19. Furthermore, the combination of RBV and LPV/r is associated with a significant increase in gastrointestinal adverse events, suggesting that RBV and LPV/r should not be co-administered to COVID-19 patients simultaneously.
Clinical Trial Registration


www.ClinicalTrials.gov, ID: ChiCTR2000029387. Registered on January 28, 2019.",2020,"The RBV+LPV/r+IFN-α-treated group developed a significantly higher incidence of gastrointestinal adverse events than the LPV/r+ IFN-α-treated group and the RBV+ IFN-α-treated group.
","['101 patients in this study', 'Patients', 'patients with mild to moderate COVID-19', 'Eligible patients with mild to moderate COVID-19']","['RBV+LPV/r+IFN-α-treated', 'Ribavirin Plus Interferon-Alpha, Lopinavir/Ritonavir Plus Interferon-Alpha, and Ribavirin Plus Lopinavir/Ritonavir Plus Interferon-Alpha', 'ribavirin (RBV) plus interferon-α (IFN-α), lopinavir/ritonavir (LPV/r) plus IFN-α, and RBV plus LPV/r plus IFN-α']","['antiviral effectiveness', 'proportion of patients with SARS-CoV-2 nucleic acid negativity', 'Antiviral Effectiveness', 'median interval to SARS-CoV-2 nucleic acid negativity, the proportion of patients with SARS-CoV-2 nucleic acid negativity', 'gastrointestinal adverse events', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002199', 'cui_str': 'interferon alfa natural'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}]","[{'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",101.0,0.0447419,"The RBV+LPV/r+IFN-α-treated group developed a significantly higher incidence of gastrointestinal adverse events than the LPV/r+ IFN-α-treated group and the RBV+ IFN-α-treated group.
","[{'ForeName': 'Yin-Qiu', 'Initials': 'YQ', 'LastName': 'Huang', 'Affiliation': 'National Key Laboratory for Infectious Diseases Prevention and Treatment with Traditional Chinese Medicine, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Sheng-Quan', 'Initials': 'SQ', 'LastName': 'Tang', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Xiao-Lei', 'Initials': 'XL', 'LastName': 'Xu', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Yan-Ming', 'Initials': 'YM', 'LastName': 'Zeng', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Xiao-Qing', 'Initials': 'XQ', 'LastName': 'He', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Harypursat', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Yan-Qiu', 'Initials': 'YQ', 'LastName': 'Lu', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wan', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Qiang-Zhong', 'Initials': 'QZ', 'LastName': 'Sun', 'Affiliation': 'Division of Tuberculosis, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Nan-Nan', 'Initials': 'NN', 'LastName': 'Sun', 'Affiliation': 'Division of Tuberculosis, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Gui-Xue', 'Initials': 'GX', 'LastName': 'Wang', 'Affiliation': 'School of Biological Engineering, Chongqing University, Chongqing, China.'}, {'ForeName': 'Zhong-Ping', 'Initials': 'ZP', 'LastName': 'Yang', 'Affiliation': 'National Key Laboratory for Infectious Diseases Prevention and Treatment with Traditional Chinese Medicine, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Yao-Kai', 'Initials': 'YK', 'LastName': 'Chen', 'Affiliation': 'National Key Laboratory for Infectious Diseases Prevention and Treatment with Traditional Chinese Medicine, Chongqing Public Health Medical Center, Chongqing, China.'}]",Frontiers in pharmacology,['10.3389/fphar.2020.01071']
1718,32765296,MNX (Medium Duration Nutrition and Resistance-Vibration Exercise) Bed-Rest: Effect of Resistance Vibration Exercise Alone or Combined With Whey Protein Supplementation on Cardiovascular System in 21-Day Head-Down Bed Rest.,"Current inflight countermeasures do not completely prevent bone and cardiovascular changes induced by microgravity. High load Resistance Exercise combined with whole body Vibration (RVE) demonstrated benefits on bone and cardiovascular system during previous Head-Down Bed Rest (HDBR) studies. We examined the effectiveness of RVE alone or combined with a nutritional supplementation of Whey protein (NeX) on cardiovascular deconditioning. Eight male subjects (age 34 ± 8 years) in a crossover design completed three 21-day HDBR campaigns (Control-CON, RVE, and NeX). Pre and post HDBR Orthostatic Tolerance (OT) was evaluated by a 15-min head-up tilt test followed by increasing levels of Lower Body Negative Pressure (LBNP). Heart rate (HR), blood pressure (BP), and Sympathetic Index (ΣI) through spectral analysis were measured during OT test. Plasma Volume (PV), and Maximal Oxygen Uptake (VO 2 max) were measured before and after each campaign. Left ventricular mass, left ventricular end diastolic (LVEDV), end systolic (LVESV), stroke (SV) volumes, and circumferential deformation at rest and during an orthostatic stress simulated by a 30 mmHg LBNP were measured by cardiac MRI. RVE failed to prevent any change in these variables and NeX did not have any additional effect over exercise alone. In the 3 groups, (1) OT time dropped similarly (bed rest  p  < 0.001), (2) HR and ΣI were increased at rest at the end of HDBR and HR increased markedly during LBNP-tilt test, with inability to increase further the ΣI, (3) PV dropped (bed rest  p  < 0.001), along with LVEDV, LVESV and SV ( p  = 0.08,  p  < 0.001, and  p  = 0.045, respectively), (4) Left ventricle mass did not change significantly, (5) Deformation of the heart assessed by global circumferential strain was preserved and early diastolic circumferential strain rate was increased during orthostatic stress at the end of HDBR, illustrating preserved systolic and diastolic function respectively, without any difference between groups. Despite the drop in PV and LV volumes, RVE and NeX tended to alleviate the decrease in VO 2 max. In conclusion, RVE and NeX failed to prevent the cardiovascular deconditioning induced by a 21 day-HDBR.",2020,"In the 3 groups, (1) OT time dropped similarly (bed rest  p  < 0.001), (2) HR and ΣI were increased at rest at the end of HDBR and HR increased markedly during LBNP-tilt test, with inability to increase further the ΣI, (3) PV dropped (bed rest  p  < 0.001), along with LVEDV, LVESV and SV ( p  = 0.08,  p  < 0.001, and  p  = 0.045, respectively), (4) Left ventricle mass did not change significantly, (5)",['Eight male subjects (age 34 ± 8 years'],"['21-day HDBR campaigns (Control-CON, RVE, and NeX', 'MNX (Medium Duration Nutrition and Resistance-Vibration Exercise', 'RVE', 'RVE alone or combined with a nutritional supplementation of Whey protein (NeX', 'High load Resistance Exercise combined with whole body Vibration (RVE', 'Resistance Vibration Exercise Alone or Combined With Whey Protein Supplementation']","['OT time', 'Left ventricular mass, left ventricular end diastolic (LVEDV), end systolic (LVESV), stroke (SV) volumes, and circumferential deformation at rest and during an orthostatic stress simulated by a 30 mmHg LBNP', 'Heart rate (HR), blood pressure (BP), and Sympathetic Index (ΣI) through spectral analysis', 'levels of Lower Body Negative Pressure (LBNP', 'Pre and post HDBR Orthostatic Tolerance (OT', 'Plasma Volume (PV), and Maximal Oxygen Uptake (VO 2 max', 'PV and LV volumes, RVE and NeX', 'cardiovascular deconditioning', 'diastolic circumferential strain rate', 'systolic and diastolic function', 'Cardiovascular System in 21-Day Head-Down Bed Rest']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0024047', 'cui_str': 'Negative lower body pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0032127', 'cui_str': 'Blood plasma volume'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0242703', 'cui_str': 'Cardiovascular deconditioning'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",8.0,0.042841,"In the 3 groups, (1) OT time dropped similarly (bed rest  p  < 0.001), (2) HR and ΣI were increased at rest at the end of HDBR and HR increased markedly during LBNP-tilt test, with inability to increase further the ΣI, (3) PV dropped (bed rest  p  < 0.001), along with LVEDV, LVESV and SV ( p  = 0.08,  p  < 0.001, and  p  = 0.045, respectively), (4) Left ventricle mass did not change significantly, (5)","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Guinet', 'Affiliation': ""Département d'Anesthésie Réanimation, Centre Hospitalier Universitaire de Rennes, Rennes, France.""}, {'ForeName': 'James Patrick', 'Initials': 'JP', 'LastName': 'MacNamara', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital, The University of Texas Southwestern Medical Center, Dallas, TX, United States.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Berry', 'Affiliation': 'Ramsay Santé, Clinique des Cèdres, Toulouse, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Larcher', 'Affiliation': ""Laboratoire de Biochimie, Centre Hospitalier Universitaire d'Angers, Angers, France.""}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Bareille', 'Affiliation': 'Institut de Médecine et de Physiologie Spatiales (MEDES), Toulouse, France.'}, {'ForeName': 'Marc-Antoine', 'Initials': 'MA', 'LastName': 'Custaud', 'Affiliation': ""Centre de Recherche Clinique, Centre Hospitalier Universitaire d'Angers, Angers, France.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Pavy-Le Traon', 'Affiliation': 'Department of Neurology, French Reference Center for MSA, University Hospital of Toulouse, Toulouse, France.'}, {'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Levine', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital, The University of Texas Southwestern Medical Center, Dallas, TX, United States.'}, {'ForeName': 'Nastassia', 'Initials': 'N', 'LastName': 'Navasiolava', 'Affiliation': ""Centre de Recherche Clinique, Centre Hospitalier Universitaire d'Angers, Angers, France.""}]",Frontiers in physiology,['10.3389/fphys.2020.00812']
1719,32765315,Emotion Regulation as a Time-Invariant and Time-Varying Covariate Predicts Outcome in an Internet-Based Psychodynamic Treatment Targeting Adolescent Depression.,"Objective


Although psychodynamic psychotherapy is efficacious in the treatment of depression, research on mechanisms of change is still scarce. The aim of this study was to investigate if and how emotion regulation affects outcome both as a time-invariant and a lagged time-varying predictor.
Method


The sample consisted of 67 adolescents diagnosed with major depressive disorder, attending affect-focused psychodynamic internet-based treatment (IPDT). Linear mixed models were used to analyze emotion regulation as a baseline predictor and to assess the effect of within-person changes in emotion regulation on depression.
Results


Analyses suggested that emotion regulation at baseline was a significant predictor of outcome, where participants with relatively larger emotion regulation deficits gained more from IPDT. Further, the results showed a significant effect of improved emotion regulation on subsequent depressive symptomatology. When not controlling for time, increased emotion regulation explained 41.23% of the variance in subsequent symptoms of depression. When detrending the results were still significant, but the amount of explained variance was reduced to 8.7%.
Conclusion


The findings suggest that patients with relatively larger deficits in emotion regulation gain more from IPDT. Decreased emotion regulation deficits seem to act as a mechanism of change in IPDT as it drives subsequent changes in depression. Clinical Trial Registration:  International Standard Randomised Controlled Trial Number (ISRCTN) 16206254, https://doi.org/10.1186/ISRCTN16206254.",2020,"Results


Analyses suggested that emotion regulation at baseline was a significant predictor of outcome, where participants with relatively larger emotion regulation deficits gained more from IPDT.","['67 adolescents diagnosed with major depressive disorder, attending affect-focused psychodynamic internet-based treatment (IPDT']","['psychodynamic psychotherapy', 'Internet-Based Psychodynamic Treatment']","['Decreased emotion regulation deficits', 'emotion regulation', 'emotion regulation gain', 'Emotion Regulation as a Time-Invariant and Time-Varying Covariate']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1261382', 'cui_str': 'Psychodynamic psychotherapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",67.0,0.0707166,"Results


Analyses suggested that emotion regulation at baseline was a significant predictor of outcome, where participants with relatively larger emotion regulation deficits gained more from IPDT.","[{'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Mechler', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Lindqvist', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Falkenström', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Carlbring', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Philips', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00671']
1720,32765402,"Excitability, Inhibition, and Neurotransmitter Levels in the Motor Cortex of Symptomatic and Asymptomatic Individuals Following Mild Traumatic Brain Injury.","Purpose:  The purpose of this study was to determine the level of excitability and inhibition, as well as the concentrations of excitatory and inhibitory neurotransmitters, in the motor cortex of individuals with acute and chronic symptoms from mTBI.  Methods:  Fifty-three individuals were assigned to one of four groups: (i) without history of mTBI (Control), (ii) within 72-h of diagnosis of mTBI (Acute), (iii) with history of mTBI and no remaining symptoms (Chronic Asymptomatic), and (iv) with chronic symptoms from mTBI, lasting at least 3 months post-injury (Chronic Symptomatic). Measures of corticospinal excitability and inhibition were obtained using transcranial magnetic stimulation (TMS). On the same day, measures of glutamate and GABA concentrations were obtained from the primary motor cortex (M1) using proton magnetic resonance spectroscopy.  Results:  MEP amplitude and area were both significantly lower in the Chronic Symptomatic group compared to the Control and Chronic Asymptomatic groups ( p  ≤ 0.05). Intracortical inhibition was not significantly different among groups ( p  = 0.14). The concentration of glutamate in M1 was similar between groups ( p  = 0.93) while there was a trend for a lower concentration of GABA in the Chronic Symptomatic group compared to the Acute group ( p  = 0.06).  Conclusions:  Individuals with chronic mTBI symptoms appear to have lower corticospinal excitability compared with acutely-injured individuals and asymptomatic controls, but the absence of differences in intracortical inhibition, and concentrations of excitatory and inhibitory neurotransmitters in M1 suggests that neurotransmitter changes in the human brain post-mTBI do not follow the pattern typically seen in the animal literature.",2020,MEP amplitude and area were both significantly lower in the Chronic Symptomatic group compared to the Control and Chronic Asymptomatic groups ( p  ≤ 0.05).,"['individuals with acute and chronic symptoms from mTBI', 'Methods:  Fifty-three individuals', 'Individuals with chronic mTBI symptoms']","['transcranial magnetic stimulation (TMS', 'without history of mTBI (Control), (ii) within 72-h of diagnosis of mTBI (Acute), (iii) with history of mTBI and no remaining symptoms (Chronic Asymptomatic']","['Intracortical inhibition', 'corticospinal excitability and inhibition', 'concentration of GABA', 'glutamate and GABA concentrations', 'concentration of glutamate in M1', 'Excitability, Inhibition, and Neurotransmitter Levels', 'MEP amplitude and area', 'corticospinal excitability']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}]","[{'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0027908', 'cui_str': 'Neurotransmitter'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",53.0,0.0900657,MEP amplitude and area were both significantly lower in the Chronic Symptomatic group compared to the Control and Chronic Asymptomatic groups ( p  ≤ 0.05).,"[{'ForeName': 'Alia L', 'Initials': 'AL', 'LastName': 'Yasen', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, OR, United States.'}, {'ForeName': 'Miranda M', 'Initials': 'MM', 'LastName': 'Lim', 'Affiliation': 'Sleep Disorders Clinic, VA Portland Health Care System, Portland, OR, United States.'}, {'ForeName': 'Kristianna B', 'Initials': 'KB', 'LastName': 'Weymann', 'Affiliation': 'Sleep Disorders Clinic, VA Portland Health Care System, Portland, OR, United States.'}, {'ForeName': 'Anita D', 'Initials': 'AD', 'LastName': 'Christie', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, OR, United States.'}]",Frontiers in neurology,['10.3389/fneur.2020.00683']
1721,32765619,Early administration of amino acids with different doses in low birth weight premature infants.,"Background


The reasonable use of amino acids (AAs) in parenteral nutrition (PN) is very critical to the growth and development of premature infants. However, the appropriate dose of AAs has not been determined. Our study was designed to investigate the clinical effect of two different doses of AAs in PN for low birth weight premature infants.
Materials and Methods


This randomized controlled study included 191 preterm infants who admitted to the neonatal intensive care unit of the First Affiliated Hospital of Nanjing Medical University from June 2015 to December 2016 and they were randomly divided into Group 1 ( n  = 81) and Group 2 ( n  = 110). In Group 1, the starting dose of AAs dose was 1.0-1.5 g/kg/day, which was increased by 0.5 g/kg with the maximum dose at 3.5 g/kg/day. In Group 2, the starting dose of AAs was 1.8-2.5 g/kg/day and was increased by 1.0 g/kg with the maximum dose at 4.0-4.5 g/kg/day. We analyzed the clinical characteristics, body weight, body length, total calorie intake, nonprotein calorie intake, total protein intake, liver and kidney function, and complications of the two groups of preterm infants.
Results


The start of enteral feeding and the recovery of birth weight in Group 2 were earlier than those in Group 1 (3.83 ± 3.15 day vs. 5.53 ± 5.63 day,  P  = 0.016 and 6.36 ± 4.88 day vs. 8.48 ± 9.27 day,  P  = 0.043, respectively). The duration of PN and the time before total enteral nutrition were shorter in Group 2 than in Group 1 (16.46 ± 10.33 day vs. 21.41 ± 18.00 day,  P  = 0.029 and 15.47 ± 10.54 day vs. 19.47 ± 14.57 day,  P  = 0.038; respectively). The duration of mechanical ventilation (1.12 ± 2.62 day vs. 3.31 ± 8.13 day,  P  = 0.028) in Group 2 was shorter than that in Group 1.
Conclusion


High doses of AAs in the early PN for preterm infants facilitate the promotion of early growth and development, advance recovery of birth weight, reduce the duration of PN, and reduce respiratory support without increasing the incidence of complications.",2020,"The duration of mechanical ventilation (1.12 ± 2.62 day vs. 3.31 ± 8.13 day,  P  = 0.028) in Group 2 was shorter than that in Group 1.
","['low birth weight premature infants', '191 preterm infants who admitted to the neonatal intensive care unit of the First Affiliated Hospital of Nanjing Medical University from June 2015 to December 2016 and they', 'premature infants']","['amino acids (AAs) in parenteral nutrition (PN', 'amino acids']","['duration of mechanical ventilation', 'clinical characteristics, body weight, body length, total calorie intake, nonprotein calorie intake, total protein intake, liver and kidney function, and complications of the two groups of preterm infants', 'duration of PN and the time before total enteral nutrition', 'recovery of birth weight']","[{'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0221097', 'cui_str': 'Length of body'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}]",191.0,0.0466901,"The duration of mechanical ventilation (1.12 ± 2.62 day vs. 3.31 ± 8.13 day,  P  = 0.028) in Group 2 was shorter than that in Group 1.
","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Pediatrics, First Affiliation Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Zhongyi', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Pediatrics, First Affiliation Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yuhua', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Pediatrics, First Affiliation Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Bingjie', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Pediatrics, First Affiliation Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Bu', 'Affiliation': 'Department of Pediatrics, First Affiliation Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Pediatrics, First Affiliation Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Shujun', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Pediatrics, First Affiliation Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, First Affiliation Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}]",Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences,['10.4103/jrms.JRMS_213_19']
1722,32765622,"Comparison of ""cough peak expiratory flow measurement"" and ""cough strength measurement using the white card test"" in extubation success: A randomized controlled trial.","Background


Failed extubation and subsequent re-intubation in ventilated patients can lead to many adverse consequences, including organizational and personal expenditures. Extubation decisions based on subjective methods are a major contributor to extubation failure. This study compared the effect of cough peak expiratory flow (PEF) measurement and cough strength measurement using the white card test (WCT) on extubation success.
Materials and Methods


This randomized clinical trial was conducted in two groups in 2018 on 88 ventilated patients in intensive care units of Imam Reza Hospital in Mashhad, Iran. Ninety patients were divided into two groups of 45, but two were excluded from the white card group. The criteria established for extubation included PEF ≥60 L/min during coughing in the cough PEF group and noticing card humidity in the WCT group. In both groups, extubation success was determined as the sole outcome and was compared with the standard PEF and cough strength. The researcher who assessed the outcome and statistician were blinded about group allocation.
Results


Extubation success was measured as 97.8% in the cough PEF group and 76.7% in the WCT group ( P  = 0.003) during the first 24 h. In the second 24 h, however, successful extubation was reported as 90.9% in the cough PEF group and 60.6% in the WCT group ( P  = 0.002).
Conclusion


Using the cough PEF rate increases the likelihood of extubation success and reduces adverse effects, and is recommended to be used for extubation decision-making.",2020,"Results


Extubation success was measured as 97.8% in the cough PEF group and 76.7% in the WCT group ( P  = 0.003) during the first 24 h.","['ventilated patients', 'two groups in 2018 on 88 ventilated patients in intensive care units of Imam Reza Hospital in Mashhad, Iran', 'Ninety patients were divided into two groups of 45, but two were excluded from the white card group']","['cough peak expiratory flow measurement"" and ""cough strength measurement', 'cough peak expiratory flow (PEF) measurement and cough strength measurement using the white card test (WCT', 'WCT']","['extubation success', 'successful extubation', 'cough', 'standard PEF and cough strength', 'Extubation success', 'adverse effects']","[{'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0521299', 'cui_str': 'Peak expiratory flow measurement'}, {'cui': 'C4708767', 'cui_str': 'Cough strength'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C4708767', 'cui_str': 'Cough strength'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",90.0,0.0438229,"Results


Extubation success was measured as 97.8% in the cough PEF group and 76.7% in the WCT group ( P  = 0.003) during the first 24 h.","[{'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Abedini', 'Affiliation': 'Department of Medical Surgical Nursing, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Froutan', 'Affiliation': 'Department of Medical Surgical Nursing, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Bagheri Moghaddam', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Mazloum', 'Affiliation': 'Department of Medical Surgical Nursing, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences,['10.4103/jrms.JRMS_939_19']
1723,32765624,Unilateral medial rectus muscle recession combined lateral rectus muscle marginal myotomy for the treatment of Duane's retraction syndrome: A promising surgical procedure.,"Background


Duane's retraction syndrome is a congenital eye movement anomaly with narrowing of the palpebral fissure and globe retraction on attempted adduction. There are several surgical approaches to treat the narrowing of the palpebral fissure. The purpose of the present study was to evaluate the efficacy of unilateral medial rectus recession (MRR) muscle combined lateral rectus (LR) muscle marginal myotomy (MM) with unilateral MRR alone in the management of narrowing of the palpebral fissure of patients with Type 1 Duane's retraction syndrome (DRS).
Materials and Methods


Twenty-eight patients with unilateral DRS Type 1 were randomly divided into two groups (14 eyes of 14 patients in each group). Age ≥5 years with DRS Type 1 with <20 prism diopters in primary position who were candidates for surgery were consecutively enrolled in this randomized controlled trial. Patients were divided into treatment groups to receive unilateral MR recession with simultaneous MM group or with unilateral MR recession alone. The amount of deviation in primary position, abnormal head position, palpebral fissure width (PFW), and up/down shoot was evaluated before and 3 months after the surgery. This study was registered at the Iranian Registry of Clinical Trials under the registration code IRCT20131229015975N3.
Results


PFW increased within MRR/MM group at the end of the study (8.86 ± 1.51) compared with the baseline (7.79 ± 1.48) ( P  < 0.001). In contrast, in the MRR/MM group, PFW did not increase statistically significantly within the MRR group at the end of the study (8.14 ± 1.35) compared with the baseline (8.07 ± 1.38) ( P  = 0.67). Mean ± standard deviation of PFW (mm) in MRR/MM group after surgery (8.86 ± 1.51) was statistically significantly higher than that in the MRR group (8.14 ± 1.35), ( P  = 0.002).
Conclusion


The results of our study demonstrate PFW significantly increased after unilateral MRR muscle combined LR muscle MM.",2020,"In contrast, in the MRR/MM group, PFW did not increase statistically significantly within the MRR group at the end of the study (8.14 ± 1.35) compared with the baseline (8.07 ± 1.38) ( P  = 0.67).","[""patients with Type 1 Duane's retraction syndrome (DRS"", 'Age ≥5 years with DRS Type 1 with <20 prism diopters in primary position who were candidates for surgery', 'Materials and Methods\n\n\nTwenty-eight patients with unilateral DRS Type 1', ""Duane's retraction syndrome""]","['unilateral MR recession with simultaneous MM group or with unilateral MR recession alone', 'unilateral medial rectus recession (MRR) muscle combined lateral rectus (LR) muscle marginal myotomy (MM) with unilateral MRR alone', 'Unilateral medial rectus muscle recession combined lateral rectus muscle marginal myotomy']","['abnormal head position, palpebral fissure width (PFW), and up/down shoot', 'PFW', 'Mean ± standard deviation of PFW (mm']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0013261', 'cui_str': ""Duane's syndrome""}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0439487', 'cui_str': 'prism diopters'}, {'cui': 'C0444508', 'cui_str': 'Primary position'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0185181', 'cui_str': 'Incision of muscle'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0395295', 'cui_str': 'Medial rectus recession'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0582821', 'cui_str': 'Lateral rectus muscle structure'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0582820', 'cui_str': 'Medial rectus muscle structure'}]","[{'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0582540', 'cui_str': 'Head position finding'}, {'cui': 'C0229244', 'cui_str': 'Structure of palpebral fissure'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]",28.0,0.0361124,"In contrast, in the MRR/MM group, PFW did not increase statistically significantly within the MRR group at the end of the study (8.14 ± 1.35) compared with the baseline (8.07 ± 1.38) ( P  = 0.67).","[{'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Zandi', 'Affiliation': 'Department of Ophthalmology, Isfahan Eye Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Amirkhani', 'Affiliation': 'Department of Ophthalmology, Isfahan Eye Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Pourazizi', 'Affiliation': 'Department of Ophthalmology, Isfahan Eye Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences,['10.4103/jrms.JRMS_836_19']
1724,32765653,Comparing post-operative analgesic effects of varying doses of dexmedetomidine as an adjuvant to ropivacaine for ultrasound-guided dual transversus abdominis plane block following laparotomy for gynecologic malignancies.,"The aim of the present study was to determine the analgesic effects of ropivacaine combined with different doses of dexmedetomidine for ultrasound-guided transversus abdominis plane (TAP) block immediately following laparotomy in patients with gynecologic malignancies. A further aim was to determine the appropriate clinical dose of dexmedetomidine as an adjuvant for ropivacaine. Patients with gynecologic malignancies scheduled for laparotomy were randomly assigned to group R (TAP block with 0.3% ropivacaine), group RD1 (TAP block with ropivacaine and 0.5 µg/kg dexmedetomidine), group RD2 (TAP block with ropivacaine and 1 µg/kg dexmedetomidine) and group RD3 (TAP block with ropivacaine and 2 µg/kg dexmedetomidine). TAP blocks were performed post-operatively. The four groups all received patient-controlled intravenous analgesia (PCIA) after the operation. The numerical rating scale (NRS) as well as the Ramsay sedation scale (RSS) scores, the first request time for PCIA bolus, oxycodone hydrochloride consumption, the plasma concentration of ropivacaine, the incidence of post-operative complications and adverse events, and patient satisfaction were recorded. Post-operative NRS scores at rest exhibited significant differences between the R group and all the RD groups at 24 h after surgery (P<0.05). Compared with the other groups, the NRS score in the RD3 group was decreased (P<0.05). The RSS scores were higher in all of the RD groups compared with those in the R group at 2 h (P<0.05) and were highest in the RD3 group compared with those in all other groups at 4 h (P<0.05). The first request time for PCIA was significantly longer in the RD3 group compared with that in the RD2, RD1 and R groups (510.47±102.67, 595.47±100.11, 682.43±104.46 and 776.42±143.91 min, respectively; P<0.05). Cumulative opioid consumption based on the number of PCIA bolus requested at 24 and 48 h post-operatively indicated that the total number of PCIA boluses was significantly lower in the RD groups compared with those in the R group at 24 and 48 h (P<0.05). The ropivacaine concentration did not differ among the four groups. There was no significant difference between groups with respect to post-operative nausea and vomiting, bradycardia and hypotension; however, all RD groups had a higher patient satisfaction than group R (P<0.05). Compared with that in the other groups, the duration of post-anesthesia care unit stay in group RD3 was relatively longer due to excessive sedation (P<0.05). In conclusion, TAP blockade using 0.5-2 µg/kg dexmedetomidine combined with 0.3% ropivacaine is a safe and effective treatment for analgesia in laparotomy procedures for gynecologic malignancies. The study was registered in the Chinese Clinical Trial Registry (CHICTR; www.chictr.org.cn) on January 15th, 2019 (registration no. ChiCTR1900020995).",2020,"There was no significant difference between groups with respect to post-operative nausea and vomiting, bradycardia and hypotension; however, all RD groups had a higher patient satisfaction than group R (P<0.05).","['laparotomy for gynecologic malignancies', 'patients with gynecologic malignancies', 'Patients with gynecologic malignancies scheduled for laparotomy']","['ropivacaine', 'ultrasound-guided transversus abdominis plane (TAP) block immediately following laparotomy', 'group R (TAP block with 0.3% ropivacaine), group RD1 (TAP block with ropivacaine and 0.5 µg/kg dexmedetomidine), group RD2 (TAP block with ropivacaine and 1 µg/kg dexmedetomidine) and group RD3 (TAP block with ropivacaine and 2 µg/kg dexmedetomidine', 'TAP blockade', 'dexmedetomidine', 'patient-controlled intravenous analgesia (PCIA']","['NRS score', 'analgesic effects', 'request time for PCIA', 'RSS scores', 'Cumulative opioid consumption', 'patient satisfaction', 'numerical rating scale (NRS', 'total number of PCIA boluses', 'Ramsay sedation scale (RSS) scores, the first request time for PCIA bolus, oxycodone hydrochloride consumption, the plasma concentration of ropivacaine, the incidence of post-operative complications and adverse events, and patient satisfaction', 'Post-operative NRS scores', 'ropivacaine concentration', 'post-operative nausea and vomiting, bradycardia and hypotension']","[{'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0441852', 'cui_str': 'Group R'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0559295', 'cui_str': 'Ramsay sedation scale'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0282274', 'cui_str': 'Oxycodone hydrochloride'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]",,0.0466807,"There was no significant difference between groups with respect to post-operative nausea and vomiting, bradycardia and hypotension; however, all RD groups had a higher patient satisfaction than group R (P<0.05).","[{'ForeName': 'Yuexiang', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Department of Anesthesiology, Hunan Cancer Hospital, Changsha, Hunan 410013, P.R. China.'}, {'ForeName': 'Yiyun', 'Initials': 'Y', 'LastName': 'Wen', 'Affiliation': 'Department of Anesthesiology, Hunan Cancer Hospital, Changsha, Hunan 410013, P.R. China.'}, {'ForeName': 'Jinfeng', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Hunan Cancer Hospital, Changsha, Hunan 410013, P.R. China.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Hunan Cancer Hospital, Changsha, Hunan 410013, P.R. China.'}]",Experimental and therapeutic medicine,['10.3892/etm.2020.8787']
1725,32765694,Expression of ADP and TNF-α in patients with gestational diabetes mellitus and its relationship with pregnancy outcomes.,"Expression of adiponectin (ADP) and tumor necrosis factor-α (TNF-α) in patients with gestational diabetes mellitus and its relationship with pregnancy outcomes was explored. A total of 78 patients with gestational diabetes mellitus admitted to Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University from June 2017 to December 2018 were enrolled as an experimental group, and further 70 healthy pregnant women in physical examination during the same period were enrolled as a control group. Concentrations of ADP and TNF-α were determined and compared between the two groups. The patients were divided into high ADP expression group (≥6.84), low ADP expression group (<6.84), high TNF-α expression group (≥6.17) and low TNF-α expression group (<6.17). Corresponding two groups were compared in terms of adverse pregnancy outcomes, respectively, and they were also compared with the control group. The clinical association between ADP and TNF-α was analyzed. TNF-α was highly expressed in the blood of patients with gestational diabetes mellitus, while ADP expression was low in the blood. The low expression of ADP was related to age, pregestational body mass index (BMI), gestational week, medical history and family history of diabetes mellitus (all P<0.05), and the high expression of TNF-α was related to age, pregestational BMI, gestational week, medical history, amniotic fluid volume, abortion history, and family history of diabetes mellitus (all P<0.05). The experimental group faced a higher risk of adverse pregnancy outcomes than the control group. Both ADP and TNF-α are abnormally expressed in the patients with gestational diabetes mellitus, and TNF-α is affected by more of the factors. The concentrations of ADP and TNF-α affect the pregnancy outcomes. It suggests that ADP and TNF-α can be used as indexes for predicating pregnancy outcomes, and for judging the disease conditions and treatment of patients.",2020,Expression of adiponectin (ADP) and tumor necrosis factor-α (TNF-α) in patients with gestational diabetes mellitus and its relationship with pregnancy outcomes was explored.,"['78 patients with gestational diabetes mellitus admitted to Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University from June 2017 to December 2018 were enrolled as an experimental group, and further 70 healthy pregnant women in physical examination during the same period were enrolled as a control group', 'patients with gestational diabetes mellitus']","['TNF-α', 'low TNF-α expression', 'ADP and TNF-α', 'TNF-α expression', 'low ADP expression']","['Expression of adiponectin (ADP) and tumor necrosis factor-α (TNF-α', 'adverse pregnancy outcomes', 'low expression of ADP', 'Concentrations of ADP and TNF-α', 'concentrations of ADP and TNF-α affect the pregnancy outcomes', 'ADP expression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",78.0,0.0117267,Expression of adiponectin (ADP) and tumor necrosis factor-α (TNF-α) in patients with gestational diabetes mellitus and its relationship with pregnancy outcomes was explored.,"[{'ForeName': 'Wengong', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': 'Department of Obstetrics and Gynecology, Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University, Shanghai 201700, P.R. China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University, Shanghai 201700, P.R. China.'}]",Experimental and therapeutic medicine,['10.3892/etm.2020.8952']
1726,32765709,Effects of vacuum sealing drainage to improve the therapeutic effect in patients with orthopedic trauma and to reduce post-operative infection and lower-limb deep venous thrombosis.,"The present study investigated the effects of vacuum sealing drainage (VSD) to improve the therapeutic efficacy in patients with orthopedic trauma (OT) and reduce post-operative infection and lower-limb deep venous thrombosis (DVT) through a retrospective analysis. A total of 76 patients with OT treated at our hospital were selected for observation. The patients were divided into the control group (CG; n=37) and the experimental group (EG; n=39) according to the treatment administered. For patients in the CG, routine dressing changes were applied. Patients in the EG underwent VSD treatment. The dressing change frequency, time between the first and second operation, hospital stay, treatment efficacy, wound healing time, interleukin-6 (IL-6) serum level, tumor necrosis factor-α (TNF-α) serum level, incidence of post-operative infection and incidence of lower-limb DVT were compared between the two groups. The dressing change frequency in the EG was less than that in the CG. The time between the first and second operation and hospital stay were shorter in the EG than in the CG (P<0.05). The total effective rate in the EG was 97.44%, which was higher than that in the CG (78.38%; P<0.05). The wound healing time in the EG was 1.72±0.73 weeks and shorter than that in the CG (2.23±0.85 weeks; P<0.05). With the progression of treatment, the serum IL-6 and TNF-α levels decreased in the two groups, but the levels in the EG were lower than those in the CG (P<0.05). The incidence of post-operative infection and lower-limb venous thrombosis in the EG were 7.69 and 0.00%, respectively, and lower than those in the CG (27.03 and 13.01%, respectively; P<0.05). In the treatment of OT, VSD may reduce the dressing change frequency, shorten the operation time and hospital stay, accelerate wound healing and reduce post-operative infection and lower-limb DVT. Thus, the VSD treatment method is worthy of promotion and implementation in clinic.",2020,The time between the first and second operation and hospital stay were shorter in the EG than in the CG (P<0.05).,"['76 patients with OT treated at our hospital were selected for observation', 'patients with orthopedic trauma (OT) and reduce post-operative infection and lower-limb deep venous thrombosis (DVT', 'patients with orthopedic trauma and to reduce post-operative infection and lower-limb deep venous thrombosis']","['vacuum sealing drainage', 'vacuum sealing drainage (VSD']","['total effective rate', 'wound healing time', 'therapeutic effect', 'dressing change frequency, time between the first and second operation, hospital stay, treatment efficacy, wound healing time, interleukin-6 (IL-6) serum level, tumor necrosis factor-α (TNF-α) serum level', 'incidence of post-operative infection and incidence of lower-limb DVT', 'serum IL-6 and TNF-α levels', 'time between the first and second operation and hospital stay', 'incidence of post-operative infection and lower-limb venous thrombosis', 'operation time and hospital stay, accelerate wound healing and reduce post-operative infection and lower-limb DVT', 'therapeutic efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274117', 'cui_str': 'Trauma & orthopedics'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}]","[{'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0085671', 'cui_str': 'Change of dressing'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",76.0,0.0119716,The time between the first and second operation and hospital stay were shorter in the EG than in the CG (P<0.05).,"[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedics, The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu 215006, P.R. China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Orthopedics, Shandong Provincial ENT Hospital Affiliated to Shandong University, Jinan, Shandong 250000, P.R. China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Orthopaedics, Binzhou Central Hospital Affiliated to Binzhou Medical University, Binzhou, Shandong 251700, P.R. China.'}, {'ForeName': 'Pingping', 'Initials': 'P', 'LastName': 'He', 'Affiliation': 'Department of Clinical Pharmacy, Binzhou Central Hospital Affiliated to Binzhou Medical University, Binzhou, Shandong 251700, P.R. China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedics, The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu 215006, P.R. China.'}, {'ForeName': 'Zhanhui', 'Initials': 'Z', 'LastName': 'Lv', 'Affiliation': 'Department of Orthopaedics, Binzhou Central Hospital Affiliated to Binzhou Medical University, Binzhou, Shandong 251700, P.R. China.'}, {'ForeName': 'Yixin', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Orthopaedics, The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu 215006, P.R. China.'}]",Experimental and therapeutic medicine,['10.3892/etm.2020.8941']
1727,32765786,Effect of multi-level stroke education on treatment and prognosis of acute ischemic stroke.,"This observational study aimed at the significance of multi-level education in the treatment and prognosis of acute ischemic stroke. Multi-level stroke education was carried out among residents and medical staff for one year in Guancheng district. After 1 year, 519 patients with acute ischemic stroke admitted to The First People's Hospital of Zhengzhou were invited to the study, 272 patients from the Guancheng district were divided into the experimental group, and 247 patients who were not from the Guancheng district but in the neighborhood of The First People's Hospital of Zhengzhou were divided into the control group. Statistical methods were applied to analyze the degree of awareness of stroke, the time from onset to hospital, the route to hospital, the number of patients coming to the hospital within 4.5 h, the number of intravenous thrombolysis, door-to-needle time (DNT), modified Rankin scale (MRS) score, and the number of hemorrhagic transformation cases. After one year of multi-level systematic stroke education, there were significant differences in stroke awareness between the experimental group and the control group in terms of limb weakness (87.87 vs. 62.75%), speech inarticulation (78.3 vs. 55.06%), facial paralysis (69.12 vs. 38.06%), limb numbness (57.35 vs. 29.15%), consciousness disorder (62.50 vs. 42.11%), walking instability with severe dizziness (39.97 vs. 15.79%) (P<0.05). There was no statistical significant difference in unclear vision or blind eyes or severe headache (P>0.05). There were statistical differences between the two groups in the time from the onset to the hospital (14.82±17.67 vs. 25.92±25.23), emergency medical services (EMS) (36.02 vs. 16.19%), number of patients coming to the hospital within 4.5 h (67 vs. 32), venous thrombolysis cases (55 vs. 17), DNT time (42.43±17.30 vs. 63.35±26.53), hemorrhagic transformation cases (11 vs. 21), and MRS score grade ≥2 (230 vs. 169) (P<0.05). Multi-level education can effectively improve the patient's awareness of stroke, encourage more patients to use EMS system to the hospital. More patients were aware that they should reach the hospital within 4.5 h. It helps shorten DNT time and give more patients the opportunity to receive intravenous thrombolysis or intravascular thrombectomy, which may improve the prognosis and reduce hemorrhagic transformation without reducing mortality.",2020,There was no statistical significant difference in unclear vision or blind eyes or severe headache (P>0.05).,"[""519 patients with acute ischemic stroke admitted to The First People's Hospital of Zhengzhou were invited to the study, 272 patients from the Guancheng district were divided into the experimental group, and 247 patients who were not from the Guancheng district but in the neighborhood of The First People's Hospital of Zhengzhou were divided into the control group"", 'residents and medical staff for one year in Guancheng district']",['multi-level stroke education'],"['venous thrombolysis cases', 'hemorrhagic transformation cases', 'stroke awareness', 'speech inarticulation', 'limb numbness', 'number of patients coming to the hospital', 'facial paralysis', 'walking instability with severe dizziness', 'emergency medical services (EMS', 'number of intravenous thrombolysis, door-to-needle time (DNT), modified Rankin scale (MRS) score', 'consciousness disorder', 'limb weakness', 'acute ischemic stroke', 'DNT time', 'unclear vision or blind eyes or severe headache']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0025106', 'cui_str': 'Medical Staffs'}, {'cui': 'C4082117', 'cui_str': 'One year'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4303794', 'cui_str': 'Education about stroke'}]","[{'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C3714584', 'cui_str': 'Transformation'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0239375', 'cui_str': 'Numbness of limbs'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0015469', 'cui_str': 'Facial palsy'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1278452', 'cui_str': 'Time from arrival at facility to administration of parenteral treatment'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009792', 'cui_str': 'Consciousness Disorders'}, {'cui': 'C0587246', 'cui_str': 'Muscle weakness of limb'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0271240', 'cui_str': 'Blindness of one eye'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]",519.0,0.0228901,There was no statistical significant difference in unclear vision or blind eyes or severe headache (P>0.05).,"[{'ForeName': 'Xiaoman', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, The First People's Hospital of Zhengzhou, Zhengzhou, Henan 450004, P.R. China.""}, {'ForeName': 'Yinfang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Neurology, The First People's Hospital of Zhengzhou, Zhengzhou, Henan 450004, P.R. China.""}, {'ForeName': 'Xinhui', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': ""Department of Neurology, The First People's Hospital of Zhengzhou, Zhengzhou, Henan 450004, P.R. China.""}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Department of Neurology, The First People's Hospital of Zhengzhou, Zhengzhou, Henan 450004, P.R. China.""}, {'ForeName': 'Yatao', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': ""Department of Neurology, The First People's Hospital of Zhengzhou, Zhengzhou, Henan 450004, P.R. China.""}, {'ForeName': 'Chaogang', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, The First People's Hospital of Zhengzhou, Zhengzhou, Henan 450004, P.R. China.""}]",Experimental and therapeutic medicine,['10.3892/etm.2020.9028']
1728,32765813,"The fruit of  Acanthopanax senticosus Harms  improves arterial stiffness and blood pressure: a randomized, placebo-controlled trial.","BACKGROUND/OBJECTIVES


Arterial stiffness and endothelial dysfunction are 2 of the independent predictors for cardiovascular disease, while  Acanthopanax senticosus Harms  (ASH) is a traditional medicinal plant that can improve cardiovascular health. This study aimed to investigate the efficacy of the fruit of ASH on vascular function in apparently healthy subjects.
SUBJECTS/METHODS


A 12-week, randomized, double-blind, placebo-controlled design, consisting of healthy adults with at least 2 of the following 3 conditions: borderline high blood pressure (BP; 120 mmHg ≤ systolic BP ≤ 160 mmHg or 80 mmHg ≤ diastolic BP ≤ 100 mmHg), smoking (≥10 cigarettes/day), and borderline blood lipid levels (220 ≤ total cholesterol ≤ 240, 130 ≤ low density lipoprotein cholesterol ≤ 165, or 150 ≤ triglyceride ≤ 220 mg/dL). Randomly assigned 76 subjects who received a placebo or 2 doses of ASH fruit (low, 500 mg/day; high, 1,000 mg/day) completed the intervention. Brachial-ankle pulse wave velocity (baPWV), flow-mediated dilation, carotid intima-media thickness, and BP were measured both at baseline and following the 12-week intervention. Endothelial nitric oxide synthase (eNOS) phosphorylation was assessed by western blotting.
RESULTS


Compared with the placebo group, the low-dose group showed more significant changes after the 12-week intervention period in terms of systolic BP (0.1 vs. -7.7 mmHg;  P  = 0.044), baPWV (31.3 vs. -98.7 cm/s;  P  = 0.007), and the ratio of phospho-eNOS/eNOS (0.8 vs. 1.22;  P  = 0.037).
CONCLUSIONS


These results suggest that ASH fruit extract at 500 mg/day has the potential to improve BP and arterial stiffness via endothelial eNOS activation in healthy adults with smoking and the tendency of having elevated BP or blood lipid parameters.
Trial Registration


Clinical Research Information Service Identifier: KCT0001072.",2020,"Compared with the placebo group, the low-dose group showed more significant changes after the 12-week intervention period in terms of systolic BP (0.1 vs. -7.7 mmHg;  P  = 0.044), baPWV (31.3 vs. -98.7 cm/s;  P  = 0.007), and the ratio of phospho-eNOS/eNOS (0.8 vs. 1.22;  P  = 0.037).
","['borderline high blood pressure (BP; 120 mmHg ≤ systolic BP ≤ 160 mmHg or 80 mmHg ≤ diastolic BP ≤ 100 mmHg), smoking (≥10 cigarettes/day), and borderline blood lipid levels (220 ≤ total cholesterol ≤ 240, 130 ≤ low density lipoprotein cholesterol ≤ 165, or 150 ≤ triglyceride ≤ 220 mg/dL', 'healthy adults with smoking', 'apparently healthy subjects', 'healthy adults with at least 2 of the following 3 conditions']","['fruit of ASH', 'placebo or 2 doses of ASH fruit', 'ASH fruit extract', 'placebo']","['baPWV', 'ratio of phospho-eNOS/eNOS', 'systolic BP', 'Endothelial nitric oxide synthase (eNOS) phosphorylation', 'BP and arterial stiffness via endothelial eNOS activation', 'Brachial-ankle pulse wave velocity (baPWV), flow-mediated dilation, carotid intima-media thickness, and BP', 'arterial stiffness and blood pressure', 'vascular function']","[{'cui': 'C2711208', 'cui_str': 'Borderline high'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0994524', 'cui_str': 'Ash'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0669365', 'cui_str': 'NOS3 protein, human'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}]",76.0,0.364672,"Compared with the placebo group, the low-dose group showed more significant changes after the 12-week intervention period in terms of systolic BP (0.1 vs. -7.7 mmHg;  P  = 0.044), baPWV (31.3 vs. -98.7 cm/s;  P  = 0.007), and the ratio of phospho-eNOS/eNOS (0.8 vs. 1.22;  P  = 0.037).
","[{'ForeName': 'Eunkyoung', 'Initials': 'E', 'LastName': 'Oh', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul 03760, Korea.'}, {'ForeName': 'Youjin', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul 03760, Korea.'}, {'ForeName': 'Soo-Yeon', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul 03760, Korea.'}, {'ForeName': 'Yeni', 'Initials': 'Y', 'LastName': 'Lim', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul 03760, Korea.'}, {'ForeName': 'Ji-Yoon', 'Initials': 'JY', 'LastName': 'Shin', 'Affiliation': 'Ewha Graduate School of Converging Clinical & Public Health, Seoul 03760, Korea.'}, {'ForeName': 'Ji Yeon', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Food Science and Technology, Seoul National University of Science and Technology, Seoul 01811, Korea.'}, {'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Cardiovascular Center, Dongguk University Ilsan Hospital, Goyang 10326, Korea.'}, {'ForeName': 'Moo-Yong', 'Initials': 'MY', 'LastName': 'Rhee', 'Affiliation': 'Cardiovascular Center, Dongguk University Ilsan Hospital, Goyang 10326, Korea.'}, {'ForeName': 'Oran', 'Initials': 'O', 'LastName': 'Kwon', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul 03760, Korea.'}]",Nutrition research and practice,['10.4162/nrp.2020.14.4.322']
1729,32765876,Oral intake of royal jelly improves anti-cancer effects and suppresses adverse events of molecular targeted therapy by regulating TNF-α and TGF-β in renal cell carcinoma: A preliminary study based on a randomized double-blind clinical trial.,"Molecular targeted therapies are commonly used in patients with metastatic renal cell carcinoma (RCC). However, the efficacy and safety of these therapeutic interventions require enhancement to improve prognosis in these patients. Royal jelly (RJ) has anti-cancer effects and adverse events across a variety of types of malignancy. The present study investigated the detailed mechanism underlying the effects of oral administration of RJ in patients with advanced RCC that were treated with molecular targeted agents in a randomized clinical trial. The study cohort comprised 16 patients treated with RJ and 17 patients treated with a placebo. Serum levels of tumor necrosis factor (TNF)-α and transforming growth factor (TGF)-β were measured using enzyme-linked immunosorbent assays. The results of the present study demonstrated a larger decrease in tumor size upon supplementing patients with RJ following molecular targeted therapy compared with that in patients administered with the placebo. Patients exhibited reduced anorexia and fatigue in the RJ group compared with the placebo group. The relative dose intensity for patients in the RJ group was higher than that in patients in the placebo group. Post- and pre-treatment ratios of the serum levels of TNF-α and TGF-β in patients in the RJ group were lower than those in patients in the placebo group, and these ratios correlated with decreasing tumor size and frequency of anorexia or fatigue in patients. In conclusion, the results of the present study indicated that oral intake of RJ improved the efficacy and safety of molecular targeted therapy in patients with RCC and changed the levels of TNF-α and TGF-β in the serum of patients, which is speculated to serve an important role in RJ-induced biological activities.",2020,"Post- and pre-treatment ratios of the serum levels of TNF-α and TGF-β in patients in the RJ group were lower than those in patients in the placebo group, and these ratios correlated with decreasing tumor size and frequency of anorexia or fatigue in patients.","['patients with RCC', 'patients with advanced RCC', 'renal cell carcinoma', 'patients with metastatic renal cell carcinoma (RCC', '16 patients treated with RJ and 17 patients treated with a']","['TNF-α and TGF-β', 'Royal jelly (RJ', 'RJ', 'royal jelly', 'placebo']","['efficacy and safety', 'serum levels of TNF-α and TGF-β', 'anorexia and fatigue', 'anti-cancer effects', 'Serum levels of tumor necrosis factor (TNF)-α and transforming growth factor ', 'tumor size and frequency of anorexia or fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0073603', 'cui_str': 'royal jelly'}]","[{'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0073603', 'cui_str': 'royal jelly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",,0.135046,"Post- and pre-treatment ratios of the serum levels of TNF-α and TGF-β in patients in the RJ group were lower than those in patients in the placebo group, and these ratios correlated with decreasing tumor size and frequency of anorexia or fatigue in patients.","[{'ForeName': 'Yasuyoshi', 'Initials': 'Y', 'LastName': 'Miyata', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Kyohei', 'Initials': 'K', 'LastName': 'Araki', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Kojiro', 'Initials': 'K', 'LastName': 'Ohba', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Tomhiro', 'Initials': 'T', 'LastName': 'Mastuo', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Yuno', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Mukai', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Asato', 'Initials': 'A', 'LastName': 'Otsubo', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Mitsunari', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Mochizuki', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Sakai', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.'}]",Molecular and clinical oncology,['10.3892/mco.2020.2099']
1730,32765902,Comparing the Effect of Monofocal and Multifocal Intraocular Lenses on Macular Surgery.,"Aim


To compare the effects of previously implanted monofocal and multifocal intraocular lenses (IOL) on macular surgery.
Methods


Seventy eyes of 70 patients with epiretinal membrane (ERM) and symptomatic vitromacular traction syndrome that previously had IOL implantation for cataract surgery were included in this prospective randomized clinical trial. Cases were divided into two groups. Group 1 and Group 2 were composed of eyes with monofocal and multifocal IOLs, respectively. The effects of refraction error and IOL decentration at the time of macular surgery performed for ERM and ILM peeling, according to the lens type, were investigated. Pars plana vitrectomy (PPV) was performed to peel ERM and ILM in all cases. Complete ophthalmological examination, fundus fluorescein angiography, and optical coherence tomography imaging were made to all cases, preoperatively and postoperatively.
Results


The mean BCVA in Group 1 and Group 2 improved from 0.69 ± 0.15 and 0.38 ± 0.14 logMAR to 0.40 ± 0.14 and 0.10 ± 0.04 logMAR, respectively, at the 6 th  month. There was no statistically significant difference between the groups in terms of the mean spherical refraction error ( P  > 0.05) and IOL decentration level ( P  > 0.05). The mean time required for macular surgery in Group 2 was statistically significantly longer than that for Group 1 ( P  < 0.05). There was no statistically significant relationship between IOL decentration and macular surgery time in Group 1 ( P  > 0.05), but there it was found in Group 2 ( P  < 0.05). In Group 2, there was a positive correlation between IOL decentration and macular surgery time.
Conclusion


In cases with multifocal IOL implants, especially with lens decentration, the time of macular surgery for ERM and ILM peeling during PPV is longer than that of eyes with monofocal IOL due to fluctuations in the clarity of the surgeon's view.",2020,There was no statistically significant difference between the groups in terms of the mean spherical refraction error ( P  > 0.05) and IOL decentration level ( P  > 0.05).,"['Macular Surgery', 'Methods\n\n\nSeventy eyes of 70 patients with epiretinal membrane (ERM) and symptomatic vitromacular traction syndrome that previously had IOL implantation for cataract surgery']","['Pars plana vitrectomy (PPV', 'implanted monofocal and multifocal intraocular lenses (IOL', 'Monofocal and Multifocal Intraocular Lenses']","['mean time required for macular surgery', 'mean BCVA', 'mean spherical refraction error', 'IOL decentration level', 'IOL decentration and macular surgery time', 'Complete ophthalmological examination, fundus fluorescein angiography, and optical coherence tomography imaging']","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}]","[{'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0493722', 'cui_str': 'Multifocal Intraocular Lens'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}, {'cui': 'C2609312', 'cui_str': 'Intraocular lens decentration'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C0430878', 'cui_str': 'Posterior segment fluorescein angiography'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",70.0,0.026787,There was no statistically significant difference between the groups in terms of the mean spherical refraction error ( P  > 0.05) and IOL decentration level ( P  > 0.05).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Altun', 'Affiliation': 'Bahcesehir University, Faculty of Medicine, Department of Ophthalmology, Istanbul, Turkey.'}]",Journal of ophthalmology,['10.1155/2020/1375298']
1731,32765904,Blood Pressure Variability and Severity of Early Prognosis in Patients with Acute Pontine Infarction.,"Background


Increased blood pressure (BP) variability may worsen the prognosis of stroke. This study aimed at investigating the association between BP variability and early functional prognosis in patients with pontine infarction.
Methods


According to types of pontine infarction, all the 137 patients were divided into two groups: 70 patients with paramedian pontine infarction (PPI) and 67 patients with deep pontine infarction (DPI). Common risk factors, 24-hour continuous blood pressure monitoring data, and the coefficient of variation were collected after admission in the hospital. Functional outcomes were evaluated with modified Rankin scale (mRS) at 3 months after discharge (favorable outcome: mRS scores ≤ 2; poor outcome: mRS scores > 2).
Results


The level of Glu, HbA1c, LDL, and NIHSS scores in the PPI group was significantly higher than that in the DPI group, and the concentration of blood uric acid was lower in the PPI group. Diastolic pressure in the PPI group is significantly higher than that in the DPI group, and coefficient of variation (CV) of systolic pressure in PPI is higher when compared with DPI ((88.77 ± 1.71) mmHg vs. (80.74 ± 1.31) mmHg; (11.54 ± 0.35) vs. (10.24 ± 0.25)). In multivariate analyses, the CV of systolic pressure, diastolic pressure, NIHSS scores, and the paramedian pontine infarction was independently associated with 3-month clinical outcome (OR = 1.94, 95% CI = 1.252-2.994,  P =0.003; OR = 1.08, 95% CI = 1.002-1.166,  P =0.04; OR = 1.58, 95% CI = 1.164-2.159,  P =0.003; OR = 9.87, 95% CI = 1.045-32.193,  P =0.04).
Conclusion


In conclusion, increased 24-hour (BP) variability, NIHSS scores, and paramedian pontine were associated with early poor prognosis in patients with acute pontine infarction.",2020,"The level of Glu, HbA1c, LDL, and NIHSS scores in the PPI group was significantly higher than that in the DPI group, and the concentration of blood uric acid was lower in the PPI group.","['137 patients were divided into two groups: 70 patients with paramedian pontine infarction (PPI) and 67 patients with deep pontine infarction (DPI', 'patients with acute pontine infarction', 'Patients with Acute Pontine Infarction', 'patients with pontine infarction']",['mRS'],"['Diastolic pressure', 'Blood Pressure Variability and Severity of Early Prognosis', 'level of Glu, HbA1c, LDL, and NIHSS scores', 'concentration of blood uric acid', 'coefficient of variation (CV) of systolic pressure in PPI', 'modified Rankin scale (mRS', 'CV of systolic pressure, diastolic pressure, NIHSS scores, and the paramedian pontine infarction', 'blood pressure (BP) variability', 'BP variability and early functional prognosis', '24-hour (BP) variability, NIHSS scores, and paramedian pontine']","[{'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441993', 'cui_str': 'Paramedian approach'}, {'cui': 'C0877587', 'cui_str': 'Pontine infarction'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0061055', 'cui_str': 'gamma-glutamyl-alpha-aminobutyrate'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0373739', 'cui_str': 'Blood uric acid'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0441993', 'cui_str': 'Paramedian approach'}, {'cui': 'C0877587', 'cui_str': 'Pontine infarction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0032639', 'cui_str': 'Pontine structure'}]",137.0,0.0464049,"The level of Glu, HbA1c, LDL, and NIHSS scores in the PPI group was significantly higher than that in the DPI group, and the concentration of blood uric acid was lower in the PPI group.","[{'ForeName': 'Xinsheng', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'The Fifth Ward of Neurology Department, Kaifeng Central Hospital, Kaifeng 475000, Henan Province, China.'}, {'ForeName': 'Gaocai', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'The Fifth Ward of Neurology Department, Kaifeng Central Hospital, Kaifeng 475000, Henan Province, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': 'The Fifth Ward of Neurology Department, Kaifeng Central Hospital, Kaifeng 475000, Henan Province, China.'}, {'ForeName': 'Hongyang', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'The Fifth Ward of Neurology Department, Kaifeng Central Hospital, Kaifeng 475000, Henan Province, China.'}, {'ForeName': 'Jianke', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'The Fifth Ward of Neurology Department, Kaifeng Central Hospital, Kaifeng 475000, Henan Province, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'The Fifth Ward of Neurology Department, Kaifeng Central Hospital, Kaifeng 475000, Henan Province, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'The Fifth Ward of Neurology Department, Kaifeng Central Hospital, Kaifeng 475000, Henan Province, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'The Fifth Ward of Neurology Department, Kaifeng Central Hospital, Kaifeng 475000, Henan Province, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""The Child Neurology Department, Kaifeng Children's Hospital, Kaifeng 475000, Henan Province, China.""}]",International journal of hypertension,['10.1155/2020/1203546']
1732,32765963,Impact of a Maternal Prevention of Mother-to-child Transmission of HIV (PMTCT) Intervention on HIV-exposed Infants in Uganda.,"Background


Uganda has successfully reduced pediatric HIV infections through prevention of mother-to-child transmission of HIV (PMTCT) programs, yet little is known about adherence to infant-specific components of interventions. We hypothesized that infants born to mothers receiving the WiseMama (WM) electronic drug monitoring (EDM)-based adherence intervention would have increased uptake of six-week post-natal nevirapine (NVP) infant prophylaxis and better adherence to six-week early infant diagnosis (EID) HIV testing.
Methods


At two sites in Uganda, the Wise Infant Study (WIN) prospectively followed an infant cohort. Infants were born to women enrolled in an RCT testing the effect of real-time reminders delivered via EDM on maternal adherence to antiretroviral therapy. We assessed intrapartum and discharge receipt of NVP prophylaxis using pharmacy and infant HIV DNA testing laboratory data.
Results


Of 121 women eligible for WIN, 97 (80%) consented and enrolled; 46 had been randomized to control and 51 to intervention. There were no differences in receipt of a six-week NVP supply (control 87%, intervention 82%, p = 0.53). Receipt of any NVP prophylaxis did not vary by delivery location (p = 0.35), and although 12% of infants were delivered at non-study health facilities, they were not less likely to receive NVP at discharge (p = 0.37). Among infants with a completed HIV test, there was no difference in mean time to first test (control 52 days (SD 18), intervention 51 days (SD 15), p = 0.86). Only one infant, in the control group, tested positive for HIV.
Conclusion and Global Health Implications


We found no significant differences in adherence to infant PMTCT practices between intervention and control infants with relatively high rates of NVP receipt albeit with suboptimal adherence to six-week EID testing. Further work is needed to ensure improved access, uptake, and follow-up of HIV-exposed infants in the Option B+ era.",2020,"There were no differences in receipt of a six-week NVP supply (control 87%, intervention 82%, p = 0.53).","['infants born to mothers receiving the', '121 women eligible for WIN, 97 (80%) consented and enrolled; 46', 'HIV-exposed Infants in Uganda']","['WiseMama (WM) electronic drug monitoring (EDM)-based adherence intervention', 'Maternal Prevention of Mother-to-child Transmission of HIV (PMTCT']","['mean time to first test', 'receipt of a six-week NVP supply']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0085421', 'cui_str': 'Medication monitoring'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0282474', 'cui_str': 'Infection Transmission, Maternal-Fetal'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",121.0,0.121712,"There were no differences in receipt of a six-week NVP supply (control 87%, intervention 82%, p = 0.53).","[{'ForeName': 'Anays', 'Initials': 'A', 'LastName': 'Murillo', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston University, 801 Massachusetts Avenue Crosstown Center, 3 Floor, Boston, MA, 02118 USA.'}, {'ForeName': 'Mary Bachman', 'Initials': 'MB', 'LastName': 'DeSilva', 'Affiliation': 'University of New England, 716 Stevens Ave, Portland, ME, 04103 USA.'}, {'ForeName': 'Lora L', 'Initials': 'LL', 'LastName': 'Sabin', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston University, 801 Massachusetts Avenue Crosstown Center, 3 Floor, Boston, MA, 02118 USA.'}, {'ForeName': 'Nafisa', 'Initials': 'N', 'LastName': 'Halim', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston University, 801 Massachusetts Avenue Crosstown Center, 3 Floor, Boston, MA, 02118 USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Chemusto', 'Affiliation': 'Mildmay Uganda, Lweza Kampala-Entebbe Road, Kampala, Uganda.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Aroda', 'Affiliation': 'Mildmay Uganda, Lweza Kampala-Entebbe Road, Kampala, Uganda.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Gasuza', 'Affiliation': 'Mildmay Uganda, Lweza Kampala-Entebbe Road, Kampala, Uganda.'}, {'ForeName': 'Davidson H', 'Initials': 'DH', 'LastName': 'Hamer', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston University, 801 Massachusetts Avenue Crosstown Center, 3 Floor, Boston, MA, 02118 USA.'}, {'ForeName': 'Anna Larson', 'Initials': 'AL', 'LastName': 'Williams', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston University, 801 Massachusetts Avenue Crosstown Center, 3 Floor, Boston, MA, 02118 USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Mukasa', 'Affiliation': 'Mildmay Uganda, Lweza Kampala-Entebbe Road, Kampala, Uganda.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Messersmith', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston University, 801 Massachusetts Avenue Crosstown Center, 3 Floor, Boston, MA, 02118 USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Bonawitz', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston University, 801 Massachusetts Avenue Crosstown Center, 3 Floor, Boston, MA, 02118 USA.'}]",International journal of MCH and AIDS,['10.21106/ijma.380']
1733,32766034,Does the Approach of the Lateral Platysmal Bands Widen the Gap between the Medial Bands?,"Background


The first visible change in an aging face and neck is the loss of neck contour, which can be corrected by treating the platysmal bands; however, it remains unclear as to which is the best strategy to approach these bands. The aim of the present study is to verify whether the lateral platysmal bands approaches, before the medial ones, cause widening of the gap between them.
Methods


This is a prospective, randomized, comparative study involving 30 individuals presenting various stages of neck and facial flaccidity and sagging. The patients were split into 2 groups according to the lateral platysmal approach (group A: lateral platysmal traction/plication; group B: lateral platysmal undermined/traction). A protocol was established to measure the gap between the medial bands, 3 and 5 cm away from the chin, before and after superficial musculoaponeurotic system/platysma lateral suspension. Measurements were taken using a compass and a ruler. The endpoint was to determine whether the gap between the medial platysmal bands widens after the lateral procedure.
Results


Group A, first measure (1-M): the gap ranged between 1.0 and 1.6 cm in point M3 (3 cm away from chin) and between 1.8 and 3.0 cm in point M5 (5 cm away from chin) (mean in M3 = 1.2; SD, 0.22 and mean in M5 =2.3; SD, 0.52). Group A, second measure (2-M): the measure ranged between 1.0 and 1.7 cm in point M3 and between 1.8 and 3.2 cm in point M5 (mean = 1.28; SD, 0.25 and mean = 2.42; SD, 0.63, respectively). Group B, first measure (1-M): the gap ranged between 1.1 and 1.7 cm in M3 (mean = 1.32; SD, 0.21) and between 1.8 and 3.2 cm in M5 (mean = 2.38; SD, 0.57). Group B, second measure (2-M): the measure ranged between 1.2 and 1.7 cm in M3 (mean = 1.4; SD, 0.18) and between 2.0 and 3.2 cm in M5 (mean = 2.5; SD, 0.55). Group A:  P  = 0.07 (M3) and 0.10 (M5); Group B:  P  = 0.09 (M3) and 0.07 (M5).
Conclusion


The lateral platysmal approach, plication or undermined, does not lead to a widening of the gap between the medial platysmal bands.",2020,"Group A:  P  = 0.07 (M3) and 0.10 (M5); Group B:  P  = 0.09 (M3) and 0.07 (M5).
",['30 individuals presenting various stages of neck and facial flaccidity and sagging'],['lateral platysmal approach (group A: lateral platysmal traction/plication; group B: lateral platysmal undermined/traction'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0026825', 'cui_str': 'Flaccidity - muscle'}, {'cui': 'C0574427', 'cui_str': 'Sango language'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]",[],30.0,0.0192337,"Group A:  P  = 0.07 (M3) and 0.10 (M5); Group B:  P  = 0.09 (M3) and 0.07 (M5).
","[{'ForeName': 'Luiz', 'Initials': 'L', 'LastName': 'Charles-de-Sá', 'Affiliation': 'Department of Plastic Reconstructive and Aesthetic Surgery, University of the Estate of Rio de Janeiro (UERJ), Rio de Janeiro, Brazil.'}, {'ForeName': 'Natale F', 'Initials': 'NF', 'LastName': 'Gontijo-de-Amorim', 'Affiliation': 'Pitanguy School and Perform Clinic, Rio de Janeiro, Brazil.'}, {'ForeName': 'Valéria', 'Initials': 'V', 'LastName': 'Loureiro Claro', 'Affiliation': 'Department of Plastic Reconstructive and Aesthetic Surgery, University of the Estate of Rio de Janeiro (UERJ), Rio de Janeiro, Brazil.'}, {'ForeName': 'Diogo Maciel Lobão', 'Initials': 'DML', 'LastName': 'Vieira', 'Affiliation': 'Department of Plastic Reconstructive and Aesthetic Surgery, University of the Estate of Rio de Janeiro (UERJ), Rio de Janeiro, Brazil.'}, {'ForeName': 'Gustavo Maltez', 'Initials': 'GM', 'LastName': 'de Andrade', 'Affiliation': 'Department of Plastic Reconstructive and Aesthetic Surgery, University of the Estate of Rio de Janeiro (UERJ), Rio de Janeiro, Brazil.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Dantas-Rocha', 'Affiliation': 'Department of Plastic Reconstructive and Aesthetic Surgery, University of the Estate of Rio de Janeiro (UERJ), Rio de Janeiro, Brazil.'}, {'ForeName': 'Cláudio Gonçalves Ramos', 'Initials': 'CGR', 'LastName': 'da Silva', 'Affiliation': 'Department of Plastic Reconstructive and Aesthetic Surgery, University of the Estate of Rio de Janeiro (UERJ), Rio de Janeiro, Brazil.'}, {'ForeName': 'José Horácio', 'Initials': 'JH', 'LastName': 'Abboudib', 'Affiliation': 'Department of Plastic Reconstructive and Aesthetic Surgery, University of the Estate of Rio de Janeiro (UERJ), Rio de Janeiro, Brazil.'}, {'ForeName': 'Cláudio Cardoso', 'Initials': 'CC', 'LastName': 'de Castro', 'Affiliation': 'Department of Plastic Reconstructive and Aesthetic Surgery, University of the Estate of Rio de Janeiro (UERJ), Rio de Janeiro, Brazil.'}]",Plastic and reconstructive surgery. Global open,['10.1097/GOX.0000000000002853']
1734,32752597,Educational Intervention Based on the Health Belief Model to Modify Risk Factors of Cardiovascular Disease in Police Officers in Iran: A Quasi-experimental Study.,"OBJECTIVES


Police officers may be at a greater risk for cardiovascular disease (CVD) than the general population due to their highstress occupation. This study evaluated how an educational program based on the health belief model (HBM) may protect police officers from developing CVD.
METHODS


In this single-group experimental study, 58 police officers in Iran participated in a 5-week intervention based on HBM principles. Outcomes included changes in scores on an HBM scale, time spent on moderate to vigorous physical activity (International Physical Activity Questionnaire), body mass index (BMI), blood lipid profile, blood glucose, and blood pressure. The intervention consisted of 5 HBM-based educational sessions. Follow-up was conducted at 3 months post-intervention. The paired t-test was used to examine differences between baseline and follow-up scores.
RESULTS


All aspects of the HBM scale improved between baseline and follow-up (p<0.05), except the cues to action subscale. Self-efficacy and preventive behaviors improved the most. BMI decreased from 26.7±2.9 kg/m2 at baseline to 25.8±2.4 kg/m2 at follow-up. All components of the lipid profile, including triglycerides, cholesterol, high-density lipoprotein, and low-density lipoprotein, showed significant improvements post-intervention. Blood glucose and blood pressure also decreased, but not significantly. Nearly 25% of participants who were not physically active at baseline increased their physical activity above or beyond the healthy threshold.
CONCLUSIONS


A relatively brief educational intervention based on HBM principles led to a significant improvement in CVD risk factors among police officers. Further research is needed to corroborate the effectiveness of this intervention.",2020,"All aspects of the HBM scale improved between baseline and follow-up (p<0.05), except the cues to action subscale.","['Police Officers in Iran', '58 police officers in Iran participated in a 5-week intervention based on HBM principles']","['5 HBM-based educational sessions', 'Educational Intervention']","['CVD risk factors', 'physical activity', 'BMI', 'triglycerides, cholesterol, high-density lipoprotein, and low-density lipoprotein', 'Blood glucose and blood pressure', 'Self-efficacy and preventive behaviors', 'HBM scale', 'HBM scale, time spent on moderate to vigorous physical activity (International Physical Activity Questionnaire), body mass index (BMI), blood lipid profile, blood glucose, and blood pressure']","[{'cui': 'C0086825', 'cui_str': 'Policeman'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3714363', 'cui_str': 'Health belief model'}]","[{'cui': 'C3714363', 'cui_str': 'Health belief model'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3714363', 'cui_str': 'Health belief model'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",58.0,0.0197036,"All aspects of the HBM scale improved between baseline and follow-up (p<0.05), except the cues to action subscale.","[{'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Saffari', 'Affiliation': 'Health Research Center, Life Style Institute, Baqiyatallah University of Medical Sciences Tehran, Iran.'}, {'ForeName': 'Hormoz', 'Initials': 'H', 'LastName': 'Sanaeinasab', 'Affiliation': 'Health Research Center, Life Style Institute, Baqiyatallah University of Medical Sciences Tehran, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Jafarzadeh', 'Affiliation': 'Health Education Department, Faculty of Health, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Sepandi', 'Affiliation': 'Health Research Center, Life Style Institute, Baqiyatallah University of Medical Sciences Tehran, Iran.'}, {'ForeName': 'Keisha-Gaye N', 'Initials': 'KN', 'LastName': ""O'Garo"", 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Harold G', 'Initials': 'HG', 'LastName': 'Koenig', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Amir H', 'Initials': 'AH', 'LastName': 'Pakpour', 'Affiliation': 'Social Determinants of Health Research Center, Qazvin University of Medical Sciences, Qazvin, Iran.'}]",Journal of preventive medicine and public health = Yebang Uihakhoe chi,['10.3961/jpmph.20.095']
1735,32753522,The Effect of Mobile Text Messages and a Novel Floss Holder on Gingival Health: A randomized control trial.,"Purpose:  The purpose of this study was to evaluate the effects of using mobile text messages and a novel floss holder as compared to finger flossing or the novel floss holder alone, on the psychological, behavioral, and clinical parameters of patients with gingivitis. Methods:  A total 165 adults were assessed for eligibility and 144 met the criteria for randomization into three groups: Finger Floss (FF, n=43), Novel Floss Holder (NFH, n= 40), and Novel Floss Holder plus Text Messages (NFH+TM, n= 61) following a dental hygiene consultation appointment. Gingival bleeding points were measured on probing (BOMP) at baseline and four months later by a calibrated dental hygienist, blinded to the experimental groups. Participants also self-reported their oral hygiene behaviors, and indicated psychological determinants of behavior change prior to the dental hygiene consultation and at four months. Descriptive statistics and repeated measures analysis of variance (ANOVA) were used to compare groups over time. Results:  Two subjects dropped out of the study making the total number of participants 142. At the four month follow-up, the NFH group and the NFH+TM groups demonstrated significantly higher levels of self-reported flossing, action self-efficacy, intention, action planning, and action control. The NFH+TM group showed lower levels of bleeding and higher levels of oral hygiene and recovery self-efficacy than the other groups, in addition to higher levels of maintenance self-efficacy as compared to the FF group. Conclusions:  The use of a novel floss holder, NFH, was shown to improve the behavioral and psychological determinants of periodontal health four months after introduction of the device. However the clinical measures of BOMP only improved significantly when used in conjunction with text messages (NFH+TM). The use of a consciousness awareness technique,TMs, in combination with a novel device, may help patients to reach therapeutic objectives and contribute to the management of periodontal pathologies such as gingivitis.",2020,"The NFH+TM group showed lower levels of bleeding and higher levels of oral hygiene and recovery self-efficacy than the other groups, in addition to higher levels of maintenance self-efficacy as compared to the FF group.","['on Gingival Health', 'Two subjects dropped out of the study making the total number of participants 142', 'patients with gingivitis', 'total 165 adults were assessed for eligibility and 144 met the criteria for randomization into three groups: Finger Floss (FF, n=43']","['NFH+TM', 'dental hygiene consultation appointment', 'Novel Floss Holder (NFH, n= 40), and Novel Floss Holder plus Text Messages (NFH+TM, n', 'NFH', 'mobile text messages', 'Mobile Text Messages and a Novel Floss Holder']","['levels of self-reported flossing, action self-efficacy, intention, action planning, and action control', 'Gingival bleeding points', 'BOMP', 'oral hygiene behaviors', 'levels of bleeding and higher levels of oral hygiene and recovery self-efficacy', 'maintenance self-efficacy']","[{'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}]","[{'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1551377', 'cui_str': 'Holder'}, {'cui': 'C0332123', 'cui_str': 'No family history of'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0017565', 'cui_str': 'Bleeding gums'}, {'cui': 'C0053926', 'cui_str': 'BOMP protocol'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",165.0,0.0182216,"The NFH+TM group showed lower levels of bleeding and higher levels of oral hygiene and recovery self-efficacy than the other groups, in addition to higher levels of maintenance self-efficacy as compared to the FF group.","[{'ForeName': 'Mário-Rui', 'Initials': 'MR', 'LastName': 'Araújo', 'Affiliation': ''}, {'ForeName': 'Maria-João', 'Initials': 'MJ', 'LastName': 'Alvarez', 'Affiliation': ''}, {'ForeName': 'Cristina A', 'Initials': 'CA', 'LastName': 'Godinho', 'Affiliation': ''}]",Journal of dental hygiene : JDH,[]
1736,32756564,The effect of hydration status on plasma FGF21 concentrations in humans: A subanalysis of a randomised crossover trial.,"AIM


Fibroblast growth factor 21 (FGF21) has recently been implicated in thirst in rodent models. The mechanisms for this are currently uncertain, and it is unclear whether hydration status can alter FGF21 concentrations, potentially providing an additional mechanism by which hypohydration induces thirst. The aim of this study is therefore to understand whether hydration status can alter circulating FGF21 in humans.
METHODS


Using a heat tent and fluid restriction, we induced hypohydration (1.9% body mass loss) in 16 healthy participants (n = 8 men), and compared their glycaemic regulation to a rehydration protocol (heat tent and fluid replacement) in a randomised crossover design.
RESULTS


After the hypohydration procedure, urine specific gravity, urine and serum osmolality, and plasma copeptin (as a marker for arginine vasopressin) increased as expected, with no change after the rehydration protocol. In the fasted state, the median paired difference in plasma FGF21 concentrations from the rehydrated to hypohydrated trial arm was -37 (interquartile range -125, 10) pg∙mL-1(P = 0.278), with average concentrations being 458 ± 462 pg∙mL-1 after hypohydration and 467 ± 438 pg∙mL-1 after rehydration; mean difference -9 ± 173 pg∙mL-1.
CONCLUSION


To our knowledge, these are the first causal data in humans investigating hydration and FGF21, demonstrating that an acute bout of hypohydration does not impact fasted plasma FGF21 concentrations. These data may suggest that whilst previous research has found FGF21 administration can induce thirst and drinking behaviours, a physiological state implicated in increased thirst (hypohydration) does not appear to impact plasma FGF21 concentrations in humans.",2020,FGF21 concentrations from the rehydrated to hypohydrated trial arm was -37,"['16 healthy participants (n = 8 men', 'humans']","['hydration status', 'rehydration protocol (heat tent and fluid replacement', 'Fibroblast growth factor 21 (FGF21']","['FGF21 concentrations', 'urine specific gravity, urine and serum osmolality, and plasma copeptin (as a marker for arginine vasopressin', 'plasma FGF21 concentrations', 'plasma']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0034997', 'cui_str': 'Rehydration therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0677506', 'cui_str': 'Tent'}, {'cui': 'C0521302', 'cui_str': 'Body fluid replacement'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}]","[{'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0202517', 'cui_str': 'Urinalysis, specific gravity measurement'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0202151', 'cui_str': 'Osmolality measurement, serum'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0056279', 'cui_str': 'copeptins'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}]",16.0,0.122116,FGF21 concentrations from the rehydrated to hypohydrated trial arm was -37,"[{'ForeName': 'Harriet A', 'Initials': 'HA', 'LastName': 'Carroll', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Yung-Chih', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Templeman', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'James', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Trim', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0235557']
1737,32756916,Clinical Application of High-Sensitivity Troponin Testing in the Atherosclerotic Cardiovascular Disease Framework of the Current Cholesterol Guidelines.,"Importance


The 2018 American Heart Association/American College of Cardiology (AHA/ACC) cholesterol management guidelines identified 2 distinct groups of patients with atherosclerotic cardiovascular disease (ASCVD) prompting different treatment recommendations.
Objective


To investigate whether the addition of high-sensitivity troponin (hsTn) testing to guideline-derived ASCVD risk can improve risk classification and downstream treatment recommendations.
Design, Setting, and Participants


A prospective cohort biomarker substudy was performed that included 8635 patients enrolled in the Prevention of Cardiovascular Events in Patients with Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54 (PEGASUS-TIMI 54) trial. Patients were assigned to risk groups of either very high-risk ASCVD or lower-risk ASCVD based on their cardiovascular history and comorbidities, in line with the 2018 AHA/ACC cholesterol management guidelines criteria. Patients were also classified on the basis of hsTnI level (ARCHITECT assay; Abbott) using cut points of 2 ng/L (limit of detection) and 6 ng/L (risk threshold), followed by joint classification on the basis of clinical features and hsTnI level. The setting was a nested prospective cohort study in a completed multinational trial. Participants were all patients who had a myocardial infarction 1 to 3 years before enrollment, were at least 50 years of age, and had at least 1 high-risk feature. The study dates were October 2010 to December 2014. The dates of analysis were June 2019 to January 2020.
Main Outcomes and Measures


The primary end point was a composite of cardiovascular death, myocardial infarction, or stroke.
Results


Among 8635 patients enrolled in the PEGASUS-TIMI 54 trial, the median age was 65 years (interquartile range, 58-71 years), and 6614 (76.6%) were men; 8340 (96.6%) were White individuals and 176 (2.0%) were Black individuals. Patients meeting clinical criteria for the very high-risk ASCVD group had a primary end point 3-year event rate of 8.8% compared with 5.0% in the lower-risk ASCVD group (hazard ratio, 2.01; 95% CI, 1.58-2.57; P < .001). When patients in the very high-risk ASCVD group were further risk stratified by hsTnI level, 614 of 6789 patients (9.0%) with an undetectable hsTnI level had a 3-year event rate of 2.7% (<1% per year), which was less than the overall rate in the lower-risk ASCVD group. Analogously, in the lower-risk ASCVD group, 417 of 1846 patients (22.6%) with an hsTnI level exceeding 6 ng/L had an event rate of 9.1%, comparable to the overall rate in the very high-risk ASCVD group. The addition of hsTnI to guideline-derived ASCVD risk led to a net reclassification index at event rate of 0.15 (95% CI, 0.10-0.21). Overall, use of hsTnI reclassified 1031 of 8635 patients (11.9%) (1 in 11 with very high-risk ASCVD and 1 in 4 with lower-risk ASCVD).
Conclusions and Relevance


The findings of this cohort substudy suggest that a strategy incorporating hsTn into a guideline-derived ASCVD risk algorithm provides enhanced risk stratification and reclassifies 11.9% of patients into a more appropriate risk group. This application of hsTn testing might be used to optimize the care of patients with ASCVD.",2020,"Overall, use of hsTnI reclassified 1031 of 8635 patients (11.9%) (1 in 11 with very high-risk ASCVD and 1 in 4 with lower-risk ASCVD).
","['2018 American Heart Association/American College of Cardiology (AHA/ACC) cholesterol management guidelines identified 2 distinct groups of patients with atherosclerotic cardiovascular disease (ASCVD', '8635 patients enrolled in the PEGASUS-TIMI 54 trial, the median age was 65 years (interquartile range, 58-71 years), and 6614 (76.6%) were men; 8340 (96.6%) were White individuals and 176 (2.0%) were Black individuals', '8635 patients enrolled in the Prevention of Cardiovascular Events in Patients with Prior Heart Attack Using', 'Participants were all patients who had a myocardial infarction 1 to 3 years before enrollment, were at least 50 years of age, and had at least 1 high-risk feature', 'patients with ASCVD', 'Patients were assigned to risk groups of either very high-risk ASCVD or lower-risk ASCVD based on their cardiovascular history and comorbidities, in line with the 2018 AHA/ACC cholesterol management guidelines criteria']","['Ticagrelor', 'High-Sensitivity Troponin', 'Placebo', 'Aspirin-Thrombolysis']","['3-year event rate', 'overall rate', 'composite of cardiovascular death, myocardial infarction, or stroke']","[{'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0050451', 'cui_str': 'acetohydroxamic acid'}, {'cui': 'C0175754', 'cui_str': 'Agenesis of corpus callosum'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0442804', 'cui_str': 'Very high'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",8635.0,0.0553127,"Overall, use of hsTnI reclassified 1031 of 8635 patients (11.9%) (1 in 11 with very high-risk ASCVD and 1 in 4 with lower-risk ASCVD).
","[{'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Marston', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': 'Colorado Prevention Center (CPC) Clinical Research, Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Jarolim', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Goodrich', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Philippe G', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Division of Cardiology, Assistance Publique-Hôpitaux de Paris, Université de Paris, Paris, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': 'Newark Beth Israel Medical Center, Rutgers New Jersey Medical School, Newark.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Division of Cardiology, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Johanson', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}]",JAMA cardiology,['10.1001/jamacardio.2020.2981']
1738,32756930,Effect of Spinal Manipulative and Mobilization Therapies in Young Adults With Mild to Moderate Chronic Low Back Pain: A Randomized Clinical Trial.,"Importance


Low back pain (LBP) is one of the most common reasons for seeking medical care. Manual therapy is a common treatment of LBP, yet few studies have directly compared the effectiveness of thrust (spinal manipulation) vs nonthrust (spinal mobilization) techniques.
Objective


To evaluate the comparative effectiveness of spinal manipulation and spinal mobilization at reducing pain and disability compared with a placebo control group (sham cold laser) in a cohort of young adults with chronic LBP.
Design, Setting, and Participants


This single-blinded (investigator-blinded), placebo-controlled randomized clinical trial with 3 treatment groups was conducted at the Ohio Musculoskeletal and Neurological Institute at Ohio University from June 1, 2013, to August 31, 2017. Of 4903 adult patients assessed for eligibility, 4741 did not meet inclusion criteria, and 162 patients with chronic LBP qualified for randomization to 1 of 3 treatment groups. Recruitment began on June 1, 2013, and the primary completion date was August 31, 2017. Data were analyzed from September 1, 2017, to January 20, 2020.
Interventions


Participants received 6 treatment sessions of (1) spinal manipulation, (2) spinal mobilization, or (3) sham cold laser therapy (placebo) during a 3-week period.
Main Outcomes and Measures


Coprimary outcome measures were the change from baseline in Numerical Pain Rating Scale (NPRS) score over the last 7 days and the change in disability assessed with the Roland-Morris Disability Questionnaire (scores range from 0 to 24, with higher scores indicating greater disability) 48 to 72 hours after completion of the 6 treatments.
Results


A total of 162 participants (mean [SD] age, 25.0 [6.2] years; 92 women [57%]) with chronic LBP (mean [SD] NPRS score, 4.3 [2.6] on a 1-10 scale, with higher scores indicating greater pain) were randomized. Fifty-four participants were randomized to the spinal manipulation group, 54 to the spinal mobilization group, and 54 to the placebo group. There were no significant group differences for sex, age, body mass index, duration of LBP symptoms, depression, fear avoidance, current pain, average pain over the last 7 days, and self-reported disability. At the primary end point, there was no significant difference in change in pain scores between spinal manipulation and spinal mobilization (0.24 [95% CI, -0.38 to 0.86]; P = .45), spinal manipulation and placebo (-0.03 [95% CI, -0.65 to 0.59]; P = .92), or spinal mobilization and placebo (-0.26 [95% CI, -0.38 to 0.85]; P = .39). There was no significant difference in change in self-reported disability scores between spinal manipulation and spinal mobilization (-1.00 [95% CI, -2.27 to 0.36]; P = .14), spinal manipulation and placebo (-0.07 [95% CI, -1.43 to 1.29]; P = .92) or spinal mobilization and placebo (0.93 [95% CI, -0.41 to 2.29]; P = .17).
Conclusions and Relevance


In this randomized clinical trial, neither spinal manipulation nor spinal mobilization appeared to be effective treatments for mild to moderate chronic LBP.
Trial Registration


ClinicalTrials.gov Identifier: NCT01854892.",2020,"There were no significant group differences for sex, age, body mass index, duration of LBP symptoms, depression, fear avoidance, current pain, average pain over the last 7 days, and self-reported disability.","['3 treatment groups was conducted at the Ohio Musculoskeletal and Neurological Institute at Ohio University from June 1, 2013, to August 31, 2017', 'Young Adults', 'A total of 162 participants (mean [SD] age, 25.0 [6.2] years; 92 women [57%]) with chronic LBP (mean [SD] NPRS score, 4.3 [2.6] on a 1-10 scale, with higher scores indicating greater pain', 'young adults with chronic LBP', 'Fifty-four participants', '4903 adult patients assessed for eligibility, 4741 did not meet inclusion criteria, and 162 patients with chronic LBP qualified for randomization to 1 of 3 treatment groups', 'With Mild to Moderate Chronic Low Back Pain']","['Spinal Manipulative and Mobilization Therapies', 'spinal manipulation', '6 treatment sessions of (1) spinal manipulation, (2) spinal mobilization, or (3) sham cold laser therapy (placebo', 'spinal manipulation and spinal mobilization', 'placebo control group (sham cold laser', 'placebo']","['Numerical Pain Rating Scale (NPRS) score over the last 7 days and the change in disability assessed with the Roland-Morris Disability Questionnaire (scores range', 'spinal manipulation', 'change in self-reported disability scores between spinal manipulation and spinal mobilization', 'pain and disability', 'pain scores between spinal manipulation and spinal mobilization', 'sex, age, body mass index, duration of LBP symptoms, depression, fear avoidance, current pain, average pain over the last 7 days, and self-reported disability', 'spinal mobilization']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0524864', 'cui_str': 'Haematopoietic stem cell mobilisation'}, {'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0521116', 'cui_str': 'Current'}]",4903.0,0.399355,"There were no significant group differences for sex, age, body mass index, duration of LBP symptoms, depression, fear avoidance, current pain, average pain over the last 7 days, and self-reported disability.","[{'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Thomas', 'Affiliation': 'Department of Physical Therapy, Virginia Commonwealth University, Richmond.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Clark', 'Affiliation': 'Ohio Musculoskeletal and Neurological Institute, Ohio University, Athens.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Russ', 'Affiliation': 'Division of Physical Therapy, Ohio University School of Rehabilitation and Communication Sciences, Athens.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'France', 'Affiliation': 'Ohio Musculoskeletal and Neurological Institute, Ohio University, Athens.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ploutz-Snyder', 'Affiliation': 'Applied Biostatistics Laboratory, University of Michigan School of Nursing, Ann Arbor.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Corcos', 'Affiliation': 'Feinberg School of Medicine, Department of Physical Therapy and Human Movement Sciences, Northwestern University, Chicago, Illinois.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2020.12589']
1739,32755496,A Comparison of Speech Amplification and Personal Communication Devices for Hypophonia.,"Purpose This study compared the performance of three amplification devices hypothesized to improve speech communication in individuals with hypophonia (HP), as well as to identify individuals' device preferences. Method Twenty-two individuals with HP and their primary communication partners participated in a cross-over design study comparing three different speech amplification devices: a wired portable amplifier (Device A), a wireless stationary amplifier (Device B), and a one-way personal communication system (Device C). Participants attended one laboratory visit followed by 1-week trial periods with each device. At the first visit, HP participants completed speech tasks with and without the devices, in quiet and in noise. Following the in-laboratory test period, participants trialed each device at home for approximately 1 week per device. Following completion of the study, participants indicated whether or not they would like to continue using a device. Results Overall, in the presence of noise, all three devices demonstrated significant improvements in speech-to-noise levels and speech intelligibility compared to no device. A clear device hierarchy emerged such that the personal communication device (Device C) was associated with significantly better speech outcomes compared to the other two devices. The majority of participants elected to continue using a device at the completion of the study. Device preferences, however, did not clearly reflect the objective device hierarchy that was found for the objective speech measures. Each of the three devices was selected as a preferred device by at least three participants at the completion of the study. Conclusion Results from this study demonstrated clear differences in device performance in three distinct forms of amplification devices for individuals with HP. Findings suggest that amplification device use may be beneficial for this clinical population and underscore the potential to improve device availability and device selection criteria in future research. Supplemental Material https://doi.org/10.23641/asha.12735875.",2020,A clear device hierarchy emerged such that the personal communication device (Device C) was associated with significantly better speech outcomes compared to the other two devices.,"['individuals with HP', 'Method Twenty-two individuals with HP and their primary communication partners', 'individuals with hypophonia (HP']","['speech amplification devices: a wired portable amplifier (Device A), a wireless stationary amplifier (Device B), and a one-way personal communication system (Device C']","['device performance', 'speech-to-noise levels and speech intelligibility']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0521007', 'cui_str': 'Hypophonia'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0002684', 'cui_str': 'Electronic Amplifiers'}, {'cui': 'C0439835', 'cui_str': 'Stationary'}, {'cui': 'C0086792', 'cui_str': 'Personal Communication'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}]",22.0,0.148665,A clear device hierarchy emerged such that the personal communication device (Device C) was associated with significantly better speech outcomes compared to the other two devices.,"[{'ForeName': 'Thea', 'Initials': 'T', 'LastName': 'Knowles', 'Affiliation': 'Department of Communicative Disorders and Sciences, University at Buffalo, NY.'}, {'ForeName': 'Scott G', 'Initials': 'SG', 'LastName': 'Adams', 'Affiliation': 'School of Communication Sciences and Disorders, Western University, London, Ontario, Canada.'}, {'ForeName': 'Allyson', 'Initials': 'A', 'LastName': 'Page', 'Affiliation': 'School of Communication Sciences and Disorders, Western University, London, Ontario, Canada.'}, {'ForeName': 'Daryn', 'Initials': 'D', 'LastName': 'Cushnie-Sparrow', 'Affiliation': 'School of Communication Sciences and Disorders, Western University, London, Ontario, Canada.'}, {'ForeName': 'Mandar', 'Initials': 'M', 'LastName': 'Jog', 'Affiliation': 'Department of Clinical Neurological Sciences, University Hospital, London, Ontario, Canada.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2020_JSLHR-20-00085']
1740,32761068,Guidelines for the Management of Severe Traumatic Brain Injury: 2020 Update of the Decompressive Craniectomy Recommendations.,"When the fourth edition of the Brain Trauma Foundation's Guidelines for the Management of Severe Traumatic Brain Injury were finalized in late 2016, it was known that the results of the RESCUEicp (Trial of Decompressive Craniectomy for Traumatic Intracranial Hypertension) randomized controlled trial of decompressive craniectomy would be public after the guidelines were released. The guideline authors decided to proceed with publication but to update the decompressive craniectomy recommendations later in the spirit of ""living guidelines,"" whereby topics are updated more frequently, and between new editions, when important new evidence is published. The update to the decompressive craniectomy chapter presented here integrates the findings of the RESCUEicp study as well as the recently published 12-mo outcome data from the DECRA (Decompressive Craniectomy in Patients With Severe Traumatic Brain Injury) trial. Incorporation of these publications into the body of evidence led to the generation of 3 new level-IIA recommendations; a fourth previously presented level-IIA recommendation remains valid and has been restated. To increase the utility of the recommendations, we added a new section entitled Incorporating the Evidence into Practice. This summary of expert opinion provides important context and addresses key issues for practitioners, which are intended to help the clinician utilize the available evidence and these recommendations. The full guideline can be found at: https://braintrauma.org/guidelines/guidelines-for-the-management-of-severe-tbi-4th-ed#/.",2020,"When the fourth edition of the Brain Trauma Foundation's Guidelines for the Management of Severe Traumatic Brain Injury were finalized in late 2016, it was known that the results of the RESCUEicp (Trial of Decompressive Craniectomy for Traumatic Intracranial Hypertension) randomized controlled trial of decompressive craniectomy would be public after the guidelines were released.",['Patients With Severe Traumatic Brain Injury) trial'],"['DECRA (Decompressive Craniectomy', 'decompressive craniectomy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C2717817', 'cui_str': 'Decompressive craniectomy'}]",[],,0.0441026,"When the fourth edition of the Brain Trauma Foundation's Guidelines for the Management of Severe Traumatic Brain Injury were finalized in late 2016, it was known that the results of the RESCUEicp (Trial of Decompressive Craniectomy for Traumatic Intracranial Hypertension) randomized controlled trial of decompressive craniectomy would be public after the guidelines were released.","[{'ForeName': 'Gregory W J', 'Initials': 'GWJ', 'LastName': 'Hawryluk', 'Affiliation': 'Section of Neurosurgery, GB1-Health Sciences Centre, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Andres M', 'Initials': 'AM', 'LastName': 'Rubiano', 'Affiliation': 'INUB-MEDITECH Research Group, Universidad El Bosque, Bogota, Colombia.'}, {'ForeName': 'Annette M', 'Initials': 'AM', 'LastName': 'Totten', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': ""O'Reilly"", 'Affiliation': 'Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Jamie S', 'Initials': 'JS', 'LastName': 'Ullman', 'Affiliation': 'Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Bratton', 'Affiliation': 'University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Chesnut', 'Affiliation': 'University of Washington, Seattle, Washington.'}, {'ForeName': 'Odette A', 'Initials': 'OA', 'LastName': 'Harris', 'Affiliation': 'Stanford University, Stanford, California.'}, {'ForeName': 'Niranjan', 'Initials': 'N', 'LastName': 'Kissoon', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Shutter', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Tasker', 'Affiliation': ""Harvard Medical School & Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Monica S', 'Initials': 'MS', 'LastName': 'Vavilala', 'Affiliation': 'University of Washington, Seattle, Washington.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Wilberger', 'Affiliation': 'Drexel University, Pittsburgh, Pennsylvania.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Wright', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Lumba-Brown', 'Affiliation': 'Stanford University, Stanford, California.'}, {'ForeName': 'Jamshid', 'Initials': 'J', 'LastName': 'Ghajar', 'Affiliation': 'Stanford University, Stanford, California.'}]",Neurosurgery,['10.1093/neuros/nyaa278']
1741,32757879,"Prospective, Randomized, Comparative, Multicenter Study of the Hybrid Ultrasonic Advanced Bipolar Device and the Ultrasonic Coagulating Shears in Open Thyroidectomy.","Background.  The hybrid ultrasonic advanced bipolar device (HUB) that integrates ultrasonic energy and advanced bipolar energy was recently developed and applied to thyroid surgery. The purpose of this study was to compare the efficacy and safety of HUB and ultrasonic coagulating shears for open thyroidectomy.  Methods.  A total of 200 patients were enrolled from April to September 2017 in this prospective, randomized, multicenter study. Patients were randomly assigned to an ultrasonic group (n = 101) or a hybrid group (n = 99).  Results.  Operation times were similar in the 2 study groups, that is, 54.2 ± 25.2 minutes in the ultrasonic group and 50.2 ± 21.6 minutes in the hybrid group. Postoperative surgical results and morbidities were no different in the 2 groups. However, the total amount of bleeding was significantly less in the hybrid group (13.0 ± 17.7 mg vs 8.6 ± 11.5 mg;  P  = .042).  Conclusions.  Our study showed that there was no significant difference between the 2 groups in postoperative surgical results and morbidity. The total bleeding amount was significantly less in the hybrid group. The study shows that HUB is comparable to the ultrasonic coagulating shears in terms of efficacy and safety during thyroid surgery.",2020,The study shows that HUB is comparable to the ultrasonic coagulating shears in terms of efficacy and safety during thyroid surgery.,['200 patients were enrolled from April to September 2017'],"['ultrasonic coagulating shears', 'HUB and ultrasonic coagulating shears', 'ultrasonic group', 'Hybrid Ultrasonic Advanced Bipolar Device and the Ultrasonic Coagulating Shears', 'hybrid ultrasonic advanced bipolar device (HUB']","['Postoperative surgical results and morbidities', 'efficacy and safety', 'postoperative surgical results and morbidity', 'total bleeding amount', 'Operation times', 'total amount of bleeding']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",200.0,0.0183842,The study shows that HUB is comparable to the ultrasonic coagulating shears in terms of efficacy and safety during thyroid surgery.,"[{'ForeName': 'Wan Wook', 'Initials': 'WW', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, School of Medicine, 65672Kyungpook National University, Daegu, Republic of Korea.'}, {'ForeName': 'Jihyoung', 'Initials': 'J', 'LastName': 'Cho', 'Affiliation': 'Department of Surgery, School of Medicine, 37976Keimyung University, Daegu, Republic of Korea.'}, {'ForeName': 'Young San', 'Initials': 'YS', 'LastName': 'Jeon', 'Affiliation': 'Department of Surgery, Goo Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Insoo', 'Initials': 'I', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Daegu Fatima Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Young Ju', 'Initials': 'YJ', 'LastName': 'Jeong', 'Affiliation': 'Department of Surgery, School of Medicine, Catholic University of Daegu, Daegu, Republic of Korea.'}, {'ForeName': 'Jungeun', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Department of Surgery, College of Medicine, Yeungnam University, Daegu, Republic of Korea.'}, {'ForeName': 'Moo Hyun', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, School of Medicine, 37976Keimyung University, Daegu, Republic of Korea.'}, {'ForeName': 'Jehyung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Goo Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Jin Gu', 'Initials': 'JG', 'LastName': 'Kang', 'Affiliation': 'Department of Surgery, College of Medicine, Yeungnam University, Daegu, Republic of Korea.'}, {'ForeName': 'Ralph P', 'Initials': 'RP', 'LastName': 'Tufano', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Su Hwan', 'Initials': 'SH', 'LastName': 'Kang', 'Affiliation': 'Department of Surgery, College of Medicine, Yeungnam University, Daegu, Republic of Korea.'}]",Surgical innovation,['10.1177/1553350620949000']
1742,32757963,Procalcitonin to Reduce Long-Term Infection-associated Adverse Events in Sepsis: A Randomized Trial.,"Rationale Although early antimicrobial discontinuation guided by procalcitonin (PCT) has showed decreased antibiotic consumption in lower respiratory tract infections (LRTIs), the outcomes in long-term sepsis sequelae remain unclear. Objective To investigate if PCT-guidance may reduce the incidence of long-term infection-associated adverse events in sepsis. Methods In this multicenter trial, 266 sepsis (by Sepsis-3 definitions) patients with LRTIs, acute pyelonephritis, or primary bloodstream infection were randomized (1:1) to receive either PCT-guided discontinuation of antimicrobials or standard-of-care (SOC). The discontinuation criterion was ≥80% reduction in PCT levels or any PCT ≤0.5 μg/l at day 5 or later. The primary outcome was the rate of infection-associated adverse events at day 180, a composite of the incidence of any new infection by Clostridioides difficile or multidrug-resistant organisms (MDRO), or any death attributed to baseline C. difficile or MDRO infection. Secondary outcomes included 28-day mortality, length of antibiotic therapy (LOT), and cost of hospitalization. Measurements and Main Results The rate of infection-associated adverse events was 7.2% (95% CI, 3.8-13.1%; 9/125) versus 15.3% (95% CI, 10.1-22.4%; 20/131) (hazard ratio [HR], 0.45; 95% CI, 0.20-0.98; P=0.045); 28-day mortality 15.2% (95% CI,10-22.5%; 19/125) versus 28.2% (95% CI, 21.2-36.5%; 37/131) (HR, 0.51; 95% CI, 0.29-0.89; P =0.02); and median LOT 5 (range 5 to 7) versus 10 (range 7 to 15) days (P <0.001) in the PCT and SOC arms, respectively. The cost of hospitalization was also reduced in the PCT arm. Conclusions In sepsis, PCT-guidance was effective in reducing infection-associated adverse events, 28-day mortality, and cost of hospitalization. Clinical trial registration available at www.clinicaltrials.gov, ID: NCT03333304. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/).",2020,"In sepsis, PCT-guidance was effective in reducing infection-associated adverse events, 28-day mortality, and cost of hospitalization.","['Sepsis', '266 sepsis (by Sepsis-3 definitions) patients with LRTIs, acute pyelonephritis, or primary bloodstream infection', 'sepsis']","['PCT-guidance', 'PCT-guided discontinuation of antimicrobials or standard-of-care (SOC', 'procalcitonin (PCT']","['composite of the incidence of any new infection by Clostridioides difficile or multidrug-resistant organisms (MDRO), or any death attributed to baseline C. difficile or MDRO infection', 'infection-associated adverse events, 28-day mortality, and cost of hospitalization', '28-day mortality', '28-day mortality, length of antibiotic therapy (LOT), and cost of hospitalization', 'rate of infection-associated adverse events', 'cost of hospitalization', 'PCT levels', 'median LOT']","[{'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'C0520575', 'cui_str': 'Acute pyelonephritis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}]","[{'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439633', 'cui_str': 'New infection'}, {'cui': 'C0079134', 'cui_str': 'Clostridium difficile (bacteria)'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1535922', 'cui_str': 'Procalcitonin'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",266.0,0.348709,"In sepsis, PCT-guidance was effective in reducing infection-associated adverse events, 28-day mortality, and cost of hospitalization.","[{'ForeName': 'Evdoxia', 'Initials': 'E', 'LastName': 'Kyriazopoulou', 'Affiliation': 'National and Kapodistrian University of Athens School of Medicine, 68989, 4th Department of Internal Medicine, Athens, Greece.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Liaskou-Antoniou', 'Affiliation': 'National and Kapodistrian University of Athens School of Medicine, 68989, 4th Department of Internal Medicine, Athens, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Adamis', 'Affiliation': 'G. Gennimatas General Hospital of Athens, 1st Department of Internal Medicine, Athens, Greece.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Panagaki', 'Affiliation': 'National and Kapodistrian University of Athens School of Medicine, 68989, 4th Department of Internal Medicine, Athens, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Melachroinopoulos', 'Affiliation': 'National and Kapodistrian University of Athens School of Medicine, 68989, 4th Department of Internal Medicine, Athens, Greece.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Drakou', 'Affiliation': 'G. Gennimatas General Hospital of Athens, 1st Department of Internal Medicine, Athens, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Marousis', 'Affiliation': 'G. Gennimatas General Hospital of Athens, 1st Department of Internal Medicine, Athens, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Chrysos', 'Affiliation': 'Tzaneio General Hospital of Piraeus, 2nd Department of Internal Medicine, Athens, Greece.'}, {'ForeName': 'Andronikos', 'Initials': 'A', 'LastName': 'Spyrou', 'Affiliation': 'G. Gennimatas General Hospital of Athens, 1st Department of Internal Medicine, Athens, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Alexiou', 'Affiliation': 'Thriasio General Hospital of Eleusis, 1st Department of Internal Medicine, Athens, Greece.'}, {'ForeName': 'Styliani', 'Initials': 'S', 'LastName': 'Symbardi', 'Affiliation': 'Thriasio General Hospital of Eleusis, 1st Department of Internal Medicine, Athens, Greece.'}, {'ForeName': 'Zoi', 'Initials': 'Z', 'LastName': 'Alexiou', 'Affiliation': 'Thriasio General Hospital of Eleusis, 2nd Department of Internal Medicine, Athens, Greece.'}, {'ForeName': 'Styliani', 'Initials': 'S', 'LastName': 'Lagou', 'Affiliation': 'National and Kapodistrian University of Athens School of Medicine, 68989, 3rd Department of Internal Medicine, Athens, Greece.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Kolonia', 'Affiliation': 'Sismanogleio General Hospital of Athens, 2nd Department of Internal Medicine, Athens, Greece.'}, {'ForeName': 'Theologia', 'Initials': 'T', 'LastName': 'Gkavogianni', 'Affiliation': 'National and Kapodistrian University of Athens School of Medicine, 68989, 4th Department of Internal Medicine, Athens, Greece.'}, {'ForeName': 'Miltiades', 'Initials': 'M', 'LastName': 'Kyprianou', 'Affiliation': 'National and Kapodistrian University of Athens School of Medicine, 68989, 4th Department of Internal Medicine, Athens, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Anagnostopoulos', 'Affiliation': 'National and Kapodistrian University of Athens School of Medicine, 68989, 3rd Department of Internal Medicine, Athens, Greece.'}, {'ForeName': 'Garyfallia', 'Initials': 'G', 'LastName': 'Poulakou', 'Affiliation': 'National and Kapodistrian University of Athens School of Medicine, 68989, 3rd Department of Internal Medicine, Athens, Greece.'}, {'ForeName': 'Malvina', 'Initials': 'M', 'LastName': 'Lada', 'Affiliation': 'Sismanogleio General Hospital of Athens, 2nd Department of Internal Medicine, Athens, Greece.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Makkina', 'Affiliation': 'Thriasio General Hospital of Eleusis, 1st Department of Internal Medicine, Athens, Greece.'}, {'ForeName': 'Efrosyni', 'Initials': 'E', 'LastName': 'Roulia', 'Affiliation': 'Thriasio General Hospital of Eleusis, 2nd Department of Internal Medicine, Athens, Greece.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Koupetori', 'Affiliation': 'Thriasio General Hospital of Eleusis, 1st Department of Internal Medicine, Athens, Greece.'}, {'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Apostolopoulos', 'Affiliation': 'Thriasio General Hospital of Eleusis, 1st Department of Internal Medicine, Athens, Greece.'}, {'ForeName': 'Dimitra', 'Initials': 'D', 'LastName': 'Petrou', 'Affiliation': 'Thriasio General Hospital of Eleusis, 1st Department of Internal Medicine, Athens, Greece.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Nitsotolis', 'Affiliation': 'Tzaneio General Hospital of Piraeus, 2nd Department of Internal Medicine, Athens, Greece.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Antoniadou', 'Affiliation': 'National and Kapodistrian University of Athens School of Medicine, 68989, 4th Department of Internal Medicine, Athens, Greece.'}, {'ForeName': 'Evangelos J', 'Initials': 'EJ', 'LastName': 'Giamarellos-Bourboulis', 'Affiliation': 'National and Kapodistrian University of Athens School of Medicine, 68989, 4th Department of Internal Medicine, Athens, Greece; egiamarel@med.uoa.gr.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202004-1201OC']
1743,32760093,Pain during pars plana vitrectomy following sub-Tenon versus peribulbar anesthesia: A randomized trial.,"PURPOSE


To compare pain during pars plana vitrectomy (PPV) following topical lidocaine jelly and sub-Tenon anesthesia versus peribulbar anesthesia.
METHODS


Prospective, single-center, randomized study. Patients scheduled for PPV for macular hole (MH) or epiretinal membrane (ERM) at the Retina and Vitreous Section of the Department of Ophthalmology, Ribeirão Preto Medical School, University of São Paulo were randomly assigned to one of two groups in a 1:1 allocation ratio. Patients assigned to Group ST received topical anesthesia with 2% lidocaine jelly followed by sub-Tenon anesthesia with 2-4 ml of 1% ropivacaine. Patients assigned to PB received peribulbar anesthesia with 4-6 ml of 1% ropivacaine. After PPV, patients in both groups were asked to rate the level of pain they felt during the entire procedure (including anesthesia administration and PPV) by pointing at a 0-100 Visual Analogue Pain Scale (VAS). Data regarding demographics, patient characteristics and surgical features were also collected.
RESULTS


Fifty-four patients were enrolled in the study (26 in Group ST and 28 in Group PB). Baseline characteristics, including age, gender, and presence of comorbidities, were similar in both groups. The surgery performed was PPV alone in 10 and 14 patients in the ST and PB groups, respectively, and combined phacoemulsification and PPV in 16 and 14 patients in the ST and PB groups, respectively (p = 0.39, Pearson). Surgery duration (mean ± SD minutes) was similar in the two groups (62 ± 12 for ST and 70 ± 20 for PB, p = 0.09, t-Test). No patients needed supplemental topical or intravenous anesthesia during surgery. No sight- or life-threatening complication was observed in either group. VAS score was significantly lower in the ST compared to the PB group (median (interquartile range) was 1 (2.25-0) in the ST group compared to 11.5 (29.75-5) in the PB group, p< 0.0001, Wilcoxon).
CONCLUSION


In this study of patients who underwent PPV for MH or ERM, topical followed by sub-Tenon anesthesia was more effective in controlling pain during the whole vitrectomy procedure than peribulbar anesthesia. Compared to peribulbar anesthesia which is administered with a sharp needle, sub-Tenon anesthesia administered with a blunt cannula may be associated with a reduced risk of such adverse events as globe perforation, retrobulbar hemorrhage, and inadvertent injection of anesthesia into the optic nerve sheath.",2020,No sight- or life-threatening complication was observed in either group.,"['Fifty-four patients were enrolled in the study (26 in Group ST and 28 in Group PB', 'Patients scheduled for PPV for macular hole (MH) or epiretinal membrane (ERM) at the Retina and Vitreous Section of the Department of Ophthalmology, Ribeirão Preto Medical School, University of São Paulo', 'patients who underwent PPV for MH or']","['pars plana vitrectomy following sub-Tenon versus peribulbar anesthesia', 'peribulbar anesthesia', 'ERM, topical followed by sub-Tenon anesthesia', 'pars plana vitrectomy (PPV', 'topical anesthesia with 2% lidocaine jelly followed by sub-Tenon anesthesia with 2-4 ml of 1% ropivacaine', 'peribulbar anesthesia with 4-6 ml of 1% ropivacaine', 'topical lidocaine jelly and sub-Tenon anesthesia']","['VAS score', 'sight- or life-threatening complication', 'Pain', 'Surgery duration (mean ± SD minutes', 'Visual Analogue Pain Scale (VAS']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0024441', 'cui_str': 'Macular hole'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0036378', 'cui_str': 'Medical School'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0472473', 'cui_str': 'Topical local anesthetic'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0360097', 'cui_str': 'Lidocaine-containing product in cutaneous dose form'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439232', 'cui_str': 'min'}]",54.0,0.0335394,No sight- or life-threatening complication was observed in either group.,"[{'ForeName': 'Jefferson A S', 'Initials': 'JAS', 'LastName': 'Ribeiro', 'Affiliation': 'Superior School of Health Sciences, Amazonas State University, Manaus, AM, Brazil.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Ophthalmology, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Ingrid U', 'Initials': 'IU', 'LastName': 'Scott', 'Affiliation': 'Department of Ophthalmology, Penn State College of Medicine, Hershey, Pennsylvania, United States of America.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Abrão', 'Affiliation': 'Department of Biomechanics, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Jorge', 'Affiliation': 'Department of Ophthalmology, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}]",PloS one,['10.1371/journal.pone.0236624']
1744,32760097,Motor control integrated into muscle strengthening exercises has more effects on scapular muscle activities and joint range of motion before initiation of radiotherapy in oral cancer survivors with neck dissection: A randomized controlled trial.,"BACKGROUND


Accessory nerve shoulder dysfunction is common after neck dissection in oral cancer survivors. This study aimed to investigate the short-term effects of scapular muscle strengthening exercises with motor-control techniques on neck dissection-related shoulder dysfunction in oral cancer survivors before the initiation of radiotherapy.
METHODS


Thirty-eight participants were randomly allocated into the motor-control and regular-exercise groups. Each group received conventional physical therapy and specific scapular muscle strengthening exercises for 1 month immediately after neck dissection. Motor control techniques were integrated with scapular strengthening exercises for the motor-control group. Shoulder pain, active range of motion (AROM) of shoulder abduction, and scapular muscle activities including upper trapezius (UT), middle trapezius (MT), lower trapezius (LT), and serratus anterior (SA) when performing maximal voluntary isometric contraction (MVIC) and scapular muscle exercises were evaluated at baseline and after 1 month of training.
RESULTS


Both groups reduced shoulder pain and increased muscle activity of maximum voluntary isometric contraction (MVIC) of each muscle after the intervention. Increased AROM of shoulder abduction was only observed in the motor-control group (95% CI 3.80 to 20.51, p = 0.004). Relative to baseline evaluation, muscle activities of UT decreased in the motor-control group when performing shoulder shrug with 1-kg weight (95% CI -33.06 to -1.29, p = 0.034). Moreover, the SA activity decreased in the motor-control group (95% CI -29.73 to -27.68, p<0.001) but increased in the regular-exercise group (95% CI 28.16 to 30.05, p<0.001) when performing shoulder horizontal adduction and flexion.
CONCLUSION


Early strengthening exercise with motor control techniques has greater benefits for improving AROM of shoulder abduction, muscle economy, and reducing compensatory scapular muscle activities in patients with neck dissection-related shoulder dysfunction before the initiation of radiotherapy.",2020,Both groups reduced shoulder pain and increased muscle activity of maximum voluntary isometric contraction (MVIC) of each muscle after the intervention.,"['oral cancer survivors with neck dissection', 'oral cancer survivors', 'Thirty-eight participants', 'patients with neck dissection-related shoulder dysfunction']","['scapular strengthening exercises', 'radiotherapy', 'Early strengthening exercise with motor control techniques', 'Motor control integrated into muscle strengthening exercises', 'conventional physical therapy and specific scapular muscle strengthening exercises', 'scapular muscle strengthening exercises with motor-control techniques', 'motor-control and regular-exercise groups']","['muscle activities of UT', 'Shoulder pain, active range of motion (AROM) of shoulder abduction, and scapular muscle activities including upper trapezius (UT), middle trapezius (MT), lower trapezius (LT), and serratus anterior (SA', 'shoulder pain and increased muscle activity of maximum voluntary isometric contraction (MVIC', 'SA activity', 'Increased AROM of shoulder abduction', 'maximal voluntary isometric contraction (MVIC) and scapular muscle exercises']","[{'cui': 'C0153381', 'cui_str': 'Malignant tumor of oral cavity'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]","[{'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",38.0,0.090319,Both groups reduced shoulder pain and increased muscle activity of maximum voluntary isometric contraction (MVIC) of each muscle after the intervention.,"[{'ForeName': 'Yueh-Hsia', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Chi-Rung', 'Initials': 'CR', 'LastName': 'Lin', 'Affiliation': 'Rehabilitation Center, Department of Plastic and Reconstructive Surgery, Chang Gung Memorial Hospital Linkou Branch, Taoyuan, Taiwan.'}, {'ForeName': 'Wei-An', 'Initials': 'WA', 'LastName': 'Liang', 'Affiliation': 'Rehabilitation Center, Department of Plastic and Reconstructive Surgery, Chang Gung Memorial Hospital Linkou Branch, Taoyuan, Taiwan.'}, {'ForeName': 'Cheng-Ya', 'Initials': 'CY', 'LastName': 'Huang', 'Affiliation': 'School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan.'}]",PloS one,['10.1371/journal.pone.0237133']
1745,32760144,A gender-sensitised weight-loss and healthy living program for men with overweight and obesity in Australian Football League settings (Aussie-FIT): A pilot randomised controlled trial.,"BACKGROUND


Recent evidence shows that sport settings can act as a powerful draw to engage men in weight loss. The primary objective of this pilot study was to test the feasibility of delivering and to evaluate preliminary efficacy of Aussie-FIT, a weight-loss program for men with overweight/obesity delivered in Australian Football League (AFL) settings, in preparation for a future definitive trial.
METHODS AND FINDINGS


This 6-month pilot trial took place in Perth, Australia. Participants were overweight/obese (Body Mass Index [BMI] ≥ 28 kg/m2), middle-aged (35-65 years old) men. Participants were recruited in May 2018, and the intervention took place between June and December 2018. The intervention involved 12 weekly 90-min face-to-face sessions, incorporating physical activity, nutrition, and behaviour change information and practical activities delivered by coaches at 2 clubs. Data were collected at baseline and immediately postintervention. For trial feasibility purposes, 6-month follow-ups were completed. Outcomes were differences in weight loss (primary outcome) and recruitment and retention rates, self-reported measures (for example, psychological well-being), device-measured physical activity, waist size, and blood pressure at 3 months. Within 3 days of advertising at each club, 426 men registered interest; 306 (72%) were eligible. Men were selected on a first-come first-served basis (n = 130; M age = 45.8, SD = 8; M BMI = 34.48 kg/m2, SD = 4.87) and randomised by a blinded researcher. Trial retention was 86% and 63% at 3- and 6-month follow-ups (respectively). No adverse events were reported. At 3 months, mean difference in weight between groups, adjusted for baseline weight and group, was 3.3 kg (95% CI 1.9, 4.8) in favour of the intervention group (p < 0.001). The intervention group's moderate-to-vigorous physical activity (MVPA) was higher than the control group by 8.54 min/day (95% CI 1.37, 15.71, p = 0.02). MVPA among men attracted to Aussie-FIT was high at baseline (intervention arm 35.61 min/day, control arm 38.38 min/day), which may have limited the scope for improvement.
CONCLUSIONS


Aussie-FIT was feasible to deliver; participants increased physical activity, decreased weight, and reported improvements in other outcomes. Issues with retention were a limitation of this trial. In a future, fully powered randomised controlled trial (RCT), retention could be improved by conducting assessments outside of holiday seasons.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry: ACTRN12617000515392.",2020,"MVPA among men attracted to Aussie-FIT was high at baseline (intervention arm 35.61 min/day, control arm 38.38 min/day), which may have limited the scope for improvement.
","['men with overweight/obesity delivered in Australian Football League (AFL) settings', '426 men registered interest; 306 (72%) were eligible', '28 kg/m2), middle-aged (35-65 years old) men', 'men with overweight and obesity in Australian Football League settings (Aussie-FIT', 'Men were selected on a first-come first-served basis (n = 130; M age = 45.8, SD = 8; M BMI = 34.48 kg/m2, SD = 4.87', 'Participants were overweight/obese', 'Participants were recruited in May 2018, and the intervention took place between June and December 2018']","['MVPA', 'Aussie-FIT, a weight-loss program']","['weight loss (primary outcome) and recruitment and retention rates, self-reported measures (for example, psychological well-being), device-measured physical activity, waist size, and blood pressure', 'moderate-to-vigorous physical activity (MVPA', 'physical activity, decreased weight', 'adverse events']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}]","[{'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.212539,"MVPA among men attracted to Aussie-FIT was high at baseline (intervention arm 35.61 min/day, control arm 38.38 min/day), which may have limited the scope for improvement.
","[{'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Kwasnicka', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Ntoumanis', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Hunt', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Cindy M', 'Initials': 'CM', 'LastName': 'Gray', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Robert U', 'Initials': 'RU', 'LastName': 'Newton', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Perth, Australia.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Gucciardi', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Cecilie', 'Initials': 'C', 'LastName': 'Thøgersen-Ntoumani', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Olson', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'McVeigh', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Kerr', 'Affiliation': 'School of Public Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wyke', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Morgan', 'Affiliation': 'Priority Research Centre in Physical Activity and Nutrition, School of Education, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Robinson', 'Affiliation': 'School of Public Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Marshall', 'Initials': 'M', 'LastName': 'Makate', 'Affiliation': 'School of Public Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Quested', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}]",PLoS medicine,['10.1371/journal.pmed.1003136']
1746,32760148,Breastfeeding peer support by telephone in the RUBY randomised controlled trial: A qualitative exploration of volunteers' experiences.,"BACKGROUND


There is growing evidence that peer support programs may be effective in supporting breastfeeding mothers. A randomised controlled trial (RCT) (the RUBY study) that tested peer support in the Australian context found that infants of first-time mothers who received proactive telephone peer support were more likely to be receiving breastmilk at six months of age.
METHODS


This qualitative sub-study of the RUBY RCT explores the experiences and views of peer volunteers who delivered the intervention. Focus groups were conducted with 17 peers from the RUBY RCT between November 2015 and March 2016. All had provided peer support to at least one mother.
RESULTS


We found that volunteers identified strongly with the mothers' need for support when establishing breastfeeding. Key components of the support were strengthening the mothers' self-belief through affirmation and sharing experiential knowledge. Volunteers found the role rewarding and personally therapeutic although some women reported challenges initiating and maintaining contact with some mothers. Data were analysed using a hybrid approach to thematic analysis combining inductive and deductive techniques.
CONCLUSIONS


Breastfeeding peer support programs are reliant on recruitment of motivated volunteers who can provide empathetic mother-to-mother support. This study provides important information regarding volunteers' experiences that may support the upscaling of breastfeeding peer support for new mothers.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry, ACTRN 12612001024831.",2020,"that tested peer support in the Australian context found that infants of first-time mothers who received proactive telephone peer support were more likely to be receiving breastmilk at six months of age.
","['Focus groups were conducted with 17 peers from the RUBY RCT between November 2015 and March 2016', ""volunteers' experiences""]","['RUBY RCT', 'proactive telephone']",[],"[{'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]",[],,0.0535925,"that tested peer support in the Australian context found that infants of first-time mothers who received proactive telephone peer support were more likely to be receiving breastmilk at six months of age.
","[{'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Grimes', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Della A', 'Initials': 'DA', 'LastName': 'Forster', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Touran', 'Initials': 'T', 'LastName': 'Shafiei', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Amir', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'McLardie-Hore', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Helen L', 'Initials': 'HL', 'LastName': 'McLachlan', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Bundoora, Victoria, Australia.'}]",PloS one,['10.1371/journal.pone.0237190']
1747,32762708,Immediate effects of cervicothoracic junction mobilization versus thoracic manipulation on the range of motion and pain in mechanical neck pain with cervicothoracic junction dysfunction: a pilot randomized controlled trial.,"BACKGROUND


Cervicothoracic (CT) junction hypomobility has been proposed as a contributing factor for neck pain. However, there are limited studies that compared the effect of CT junction mobilization against an effective intervention in neck pain. Thoracic spine manipulation is a nonspecific intervention for neck pain where remote spinal segments are treated based on the concept of regional interdependence. The effectiveness of segment-specific spinal mobilization in the cervical spine has been researched in the last few years, and no definite conclusions could be made from the previous studies. The above reasons warrant the investigation of the effects of a specific CT junction mobilization against a nonspecific thoracic manipulation intervention in neck pain. The present study aims to compare the immediate effects of C7-T1 Maitland mobilization with thoracic manipulation in individuals with mechanical neck pain presenting with CT junction dysfunction specifically.
METHODS


A randomized clinical trial is conducted where participants with complaints of mechanical neck pain and CT junction dysfunction randomly assigned to either C7-T1 level Maitland mobilization group or mid-thoracic (T3-T6) manipulation group (active control group). In both the groups, the post graduate student (SJ) pursuing Master's in orthopedic physiotherapy delivered the intervention. The outcomes of cervical flexion, extension, side flexion & rotation range of motion (ROM) were measured before & after the intervention with a cervical range of motion (CROM) device. Self-reported pain intensity was measured with the numerical pain rating scale (NPRS). The post-intervention between-group comparison was performed using a one-way ANCOVA test.
RESULTS


Forty-two participants with mean age CT junction group: 35.14 ± 10.13 and Thoracic manipulation group: 38.47 ± 11.47 were recruited for the study. No significant differences in the post-intervention baseline adjusted outcomes of cervical ROM & self-reported pain intensity were identified between the groups after the treatment (p = 0.08, 0.95, 0.01, 0.39, 0.29, 0.27for flexion, extension, bilateral lateral flexion & rotations respectively) & neck pain intensity (p = 0.68). However, within-group, pre, and post comparison showed significant improvements in cervical ROM and pain in both groups.
CONCLUSION


This preliminary study identified that CT junction mobilization is not superior to thoracic manipulation on the outcomes of cervical ROM and neck pain when level-specific CT junction mobilization was compared with remote mid-thoracic manipulation in individuals with mechanical neck pain and CT junction dysfunction.
TRIAL REGISTRATION


CTRI: 2018/04/013088, Registered 6 April 2018, http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=24418.",2020,"No significant differences in the post-intervention baseline adjusted outcomes of cervical ROM & self-reported pain intensity were identified between the groups after the treatment (p = 0.08, 0.95, 0.01, 0.39, 0.29, 0.27for flexion, extension, bilateral lateral flexion & rotations respectively) & neck pain intensity (p = 0.68).","['participants with complaints of mechanical neck pain and CT junction dysfunction randomly assigned to either', 'individuals with mechanical neck pain presenting with CT junction dysfunction specifically', 'Forty-two participants with mean age CT junction group: 35.14\u2009±\u200910.13 and Thoracic manipulation group: 38.47\u2009±\u200911.47 were recruited for the study', 'mechanical neck pain with cervicothoracic junction dysfunction', 'individuals with mechanical neck pain and CT junction dysfunction', 'neck pain']","['cervicothoracic junction mobilization versus thoracic manipulation', 'CT junction mobilization', 'Thoracic spine manipulation', 'segment-specific spinal mobilization', 'C7-T1 level Maitland mobilization group or mid-thoracic (T3-T6) manipulation group (active control group', 'specific CT junction mobilization against a nonspecific thoracic manipulation intervention', 'C7-T1 Maitland mobilization with thoracic manipulation']","['cervical ROM & self-reported pain intensity', 'numerical pain rating scale (NPRS', 'range of motion and pain', 'cervical ROM and pain', 'neck pain intensity', 'Self-reported pain intensity', 'cervical flexion, extension, side flexion & rotation range of motion (ROM', 'cervical ROM and neck pain']","[{'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0450195', 'cui_str': 'Cervicothoracic'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0450195', 'cui_str': 'Cervicothoracic'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0581269', 'cui_str': 'Thoracic spine structure'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0446419', 'cui_str': 'Level of the first thoracic vertebra'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",42.0,0.166055,"No significant differences in the post-intervention baseline adjusted outcomes of cervical ROM & self-reported pain intensity were identified between the groups after the treatment (p = 0.08, 0.95, 0.01, 0.39, 0.29, 0.27for flexion, extension, bilateral lateral flexion & rotations respectively) & neck pain intensity (p = 0.68).","[{'ForeName': 'Shriya', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': 'Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Balthillaya', 'Affiliation': 'Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Y V Raghava', 'Initials': 'YVR', 'LastName': 'Neelapala', 'Affiliation': 'Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India. yuvaraghava999@gmail.com.'}]",Chiropractic & manual therapies,['10.1186/s12998-020-00327-4']
1748,32762718,Fire needle plus cupping for acute herpes zoster: study protocol for a randomized controlled trial.,"BACKGROUND


Acute herpes zoster (AHZ) is a common skin disease caused by invasion of the varicella zoster virus into the ganglia and skin, and the severe pain is the most complaint, which can seriously disturb the normal life of patients. Fire needle plus cupping is a special acupuncture treatment, which is widely used to treat AHZ for its better analgesic effect in China although it has not been fully verified by rigorous randomized controlled trial (RCT).
METHODS/DESIGN


To test the effect, a three-arm randomized parallel controlled trial protocol has been designed. A total of 105 AHZ patients suffering pain will be randomly divided into three groups in an equal proportion. The interventions are fire needle plus cupping (FC) in group A, famciclovir plus gabapentin (FG) in group B, and fire needle plus cupping plus famciclovir (FCF) in group C. The length for the trial is set for a week time frame. Precisely speaking, the A group (FC) is to carry out 1 treatment per day for the total of 7 treatment sessions within 1 week period. On the other hand, the B group (FG) will take drugs orally three times a day within the trial 1 week. Meanwhile, with its combination element, the C group (FCF) is due to undertake both treatments and drugs as prescribed for A and B groups within the trial week. As an intra-trial arrangement, analgesic medication will be carefully administered for temporary pain release if the sudden intolerable pain appeared. For the primary outcome, this study is due to apply visual analogue scale to identify pain intensity relief. As the secondary outcomes are concerned, this study is aiming to focus on the issues related to changes in substance P and beta-endorphin concentrations in peripheral plasma, as well as those issues of analgesic needs, side effects, symptoms, and physical signs including pain classification, local itching, burning sensation, fever, local lymphadenopathy, skin lesion area, blisters, herpes clusters, vesicular traits, ulcers, and pimples; all these are taken into account for evaluation. For the final stage, the participants are to be followed up for postherpetic neuralgia.
DISCUSSION


The results of this trial aim to provide sufficient evidence on FC treatment over both FG and FCF treatments. It will then give a credible alternative treatment to cut down acute pain and to cure AHZ infection.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR1800015372 . Registered on 28 March 2018.",2020,"As the secondary outcomes are concerned, this study is aiming to focus on the issues related to changes in substance P and beta-endorphin concentrations in peripheral plasma, as well as those issues of analgesic needs, side effects, symptoms, and physical signs including pain classification, local itching, burning sensation, fever, local lymphadenopathy, skin lesion area, blisters, herpes clusters, vesicular traits, ulcers, and pimples; all these are taken into account for evaluation.","['acute herpes zoster', 'Acute herpes zoster (AHZ', '105 AHZ patients suffering pain']","['fire needle plus cupping plus famciclovir (FCF', 'famciclovir plus gabapentin (FG', 'fire needle plus cupping (FC', 'Fire needle plus cupping']","['visual analogue scale to identify pain intensity relief', 'analgesic needs, side effects, symptoms, and physical signs including pain classification, local itching, burning sensation, fever, local lymphadenopathy, skin lesion area, blisters, herpes clusters, vesicular traits, ulcers, and pimples']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0014007', 'cui_str': 'Dismissed from job'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0209227', 'cui_str': 'famciclovir'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0497156', 'cui_str': 'Lymphadenopathy'}, {'cui': 'C0037284', 'cui_str': 'Skin lesion'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0005758', 'cui_str': 'Blister'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205378', 'cui_str': 'Vesicular'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0241157', 'cui_str': 'Pustule'}]",105.0,0.0853366,"As the secondary outcomes are concerned, this study is aiming to focus on the issues related to changes in substance P and beta-endorphin concentrations in peripheral plasma, as well as those issues of analgesic needs, side effects, symptoms, and physical signs including pain classification, local itching, burning sensation, fever, local lymphadenopathy, skin lesion area, blisters, herpes clusters, vesicular traits, ulcers, and pimples; all these are taken into account for evaluation.","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'The Six Affiliated Hospital of Kunming Medical University, Yuxi, 653100, China.'}, {'ForeName': 'Zuohui', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'The Six Affiliated Hospital of Kunming Medical University, Yuxi, 653100, China.'}, {'ForeName': 'Shihua', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'The Six Affiliated Hospital of Kunming Medical University, Yuxi, 653100, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'The Six Affiliated Hospital of Kunming Medical University, Yuxi, 653100, China.'}, {'ForeName': 'Taipin', 'Initials': 'T', 'LastName': 'Guo', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina and Rehabilitation, Yunnan University of Chinese Medicine, Kunming, 650500, China. gtphncs@126.com.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""The Third People's Hospital of Yunnan Province, Kunming, 650011, China.""}, {'ForeName': 'Juanjuan', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'The Six Affiliated Hospital of Kunming Medical University, Yuxi, 653100, China.'}, {'ForeName': 'Qiannan', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': 'The Six Affiliated Hospital of Kunming Medical University, Yuxi, 653100, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'The Six Affiliated Hospital of Kunming Medical University, Yuxi, 653100, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'The Six Affiliated Hospital of Kunming Medical University, Yuxi, 653100, China.'}, {'ForeName': 'Cailian', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'The Six Affiliated Hospital of Kunming Medical University, Yuxi, 653100, China.'}, {'ForeName': 'Xiuhong', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'The Six Affiliated Hospital of Kunming Medical University, Yuxi, 653100, China. 734182946@qq.com.'}]",Trials,['10.1186/s13063-020-04599-2']
1749,32762736,Differential and shared effects of psychological skills training and mindfulness training on performance-relevant psychological factors in sport: a randomized controlled trial.,"BACKGROUND


Mental training intends to support athletes in mastering challenges in sport. The aim of our study was to investigate the differential and shared effects of psychological skills training and mindfulness training on psychological variables relevant to athletic performance (e.g., handling emotions or attention control). We assumed that each approach has its own strengths (e.g., mindfulness has a differential effect on the acceptance of emotions), but for some goals (e.g., attention control), both training forms are expected to be equally successful (i.e., shared effects).
METHODS


A total of 95 athletes (M age  = 24.43, SD age  = 5.15; 49% female) were randomly assigned into three groups: psychological skills training intervention (PST), mindfulness training intervention (MT), and wait-list control group (WL). Participants completed a questionnaire battery before and after the training (pretest and posttest). We assessed mindfulness, use of mental strategies, handling of emotions, attention in training and competition, as well as the dealing with failure. The two intervention programs each consisted of four 90-min group workshops conducted over a period of 4 weeks.
RESULTS


Both interventions passed the manipulation check, that is, PST led to more mental strategies being used (probabilities > 95%), and MT led to an increase in two of three aspects of mindfulness (probabilities > 98%) when compared to WL. Compared to WL, both interventions equally improved in the ability to not let emotions interfere with performance (probabilities > 99%) and in controlling attention in training and competition (probabilities > 89%). To a lesser extend, both interventions showed shared improvements in dealing with failure indicated by more action orientation (probabilities > 82%). We found a differential effect of MT on decreased experiential avoidance: MT decreased compared to WL and PST (probabilities > 92%), whereas PST did not differ from WL.
CONCLUSION


We conclude that both forms of mental training lead to improvements in performance-relevant psychological factors, especially concerning the handling of emotions and attention control. The results of our study suggest that different paths may lead to the desired outcomes, and accordingly, both forms of mental training seem justified.
TRIAL REGISTRATION NUMBER


ISRCTN11147748 , date of registration: July 11, 2016.",2020,"Compared to WL, both interventions equally improved in the ability to not let emotions interfere with performance (probabilities > 99%) and in controlling attention in training and competition (probabilities > 89%).","['95 athletes (M age \u2009=\u200924.43, SD age \u2009=\u20095.15; 49% female', 'sport']","['MT', 'psychological skills training intervention (PST), mindfulness training intervention (MT), and wait-list control group (WL', 'psychological skills training and mindfulness training']","['experiential avoidance: MT', 'performance-relevant psychological factors']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038039', 'cui_str': 'Sport'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0033898', 'cui_str': 'Factors, Psychological'}]",95.0,0.0404468,"Compared to WL, both interventions equally improved in the ability to not let emotions interfere with performance (probabilities > 99%) and in controlling attention in training and competition (probabilities > 89%).","[{'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Röthlin', 'Affiliation': 'Swiss Federal Institute of Sport, Alpenstrasse 18, CH-2532, Magglingen, Switzerland. philipp.roethlin@baspo.admin.ch.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Horvath', 'Affiliation': 'Swiss Federal Institute of Sport, Alpenstrasse 18, CH-2532, Magglingen, Switzerland.'}, {'ForeName': 'Severin', 'Initials': 'S', 'LastName': 'Trösch', 'Affiliation': 'Swiss Federal Institute of Sport, Alpenstrasse 18, CH-2532, Magglingen, Switzerland.'}, {'ForeName': 'Martin Grosse', 'Initials': 'MG', 'LastName': 'Holtforth', 'Affiliation': 'Institute for Psychology, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Birrer', 'Affiliation': 'Swiss Federal Institute of Sport, Alpenstrasse 18, CH-2532, Magglingen, Switzerland.'}]",BMC psychology,['10.1186/s40359-020-00449-7']
1750,32762763,Percutaneous vertebroplasty with high- versus low-viscosity bone cement for osteoporotic vertebral compression fractures.,"OBJECTIVE


There is no consensus on the best choice between high- and low-viscosity bone cement for percutaneous vertebroplasty (PVP). This study aimed to compare the clinical and radiological outcomes and leakage between three cements with different viscosities in treating osteoporotic vertebral compression fractures.
METHODS


This is a prospective study comparing patients who were treated with PVP under local anesthesia: group A (n = 99, 107 vertebrae) with high-viscosity OSTEOPAL V cement, group B (n = 79, 100 vertebrae) with low-viscosity OSTEOPAL V cement, and group C (n = 88, 102 vertebrae) with low-viscosity Eurofix VTP cement. Postoperative pain severity was evaluated using the visual analog scale. Cement leakage was evaluated using radiography and computed tomography.
RESULTS


There was no significant difference in the incidence of cement leakage between the three groups (group A 20.6%, group B 24.2%, group C 20.6%, P = 0.767). All three groups showed significant reduction in postoperative pain scores but did not differ significantly in pain scores at postoperative 2 days (group A 2.01 ± 0.62, group B 2.15 ± 0.33, group C 1.92 ± 0.71, P = 0.646). During the 6 months after cement implantation, significantly less reduction in the fractured vertebral body height was noticed in group B and group C than in group A (group A 19.0%, group B 8.1%, group C 7.3%, P = 0.009).
CONCLUSIONS


Low-viscosity cement has comparable incidence of leakage compared to high-viscosity cement in PVP for osteoporotic vertebral compression fractures. It also can better prevent postoperative loss of fractured vertebral body's height.",2020,"All three groups showed significant reduction in postoperative pain scores but did not differ significantly in pain scores at postoperative 2 days (group A 2.01 ± 0.62, group B 2.15 ± 0.33, group C 1.92 ± 0.71, P = 0.646).","['osteoporotic vertebral compression fractures', 'patients who were treated with PVP under local anesthesia: group A (n = 99, 107 vertebrae) with']","['Percutaneous vertebroplasty with high- versus low-viscosity bone cement', 'low-viscosity Eurofix VTP cement', 'high-viscosity OSTEOPAL V cement']","['pain scores', 'postoperative pain scores', 'Cement leakage', 'Postoperative pain severity', 'fractured vertebral body height', 'incidence of cement leakage', 'visual analog scale']","[{'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0032856', 'cui_str': 'Povidone'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C0005934', 'cui_str': 'Bone cements'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C1744326', 'cui_str': 'osteopal V'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0163968,"All three groups showed significant reduction in postoperative pain scores but did not differ significantly in pain scores at postoperative 2 days (group A 2.01 ± 0.62, group B 2.15 ± 0.33, group C 1.92 ± 0.71, P = 0.646).","[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Miao', 'Affiliation': 'Department of Spine Surgery, Renmin Hospital, Hubei University of Medicine, No.39 Middle Chaoyang Road, Shiyan, 442000, Hubei, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'Department of Spine Surgery, Renmin Hospital, Hubei University of Medicine, No.39 Middle Chaoyang Road, Shiyan, 442000, Hubei, China. znchick@163.com.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Spine Surgery, Renmin Hospital, Hubei University of Medicine, No.39 Middle Chaoyang Road, Shiyan, 442000, Hubei, China.'}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Department of Spine Surgery, Renmin Hospital, Hubei University of Medicine, No.39 Middle Chaoyang Road, Shiyan, 442000, Hubei, China.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-01835-y']
1751,32766321,"A new method of ""student-centered formative assessment"" and improving students' performance: An effort in the health promotion of community.","BACKGROUND


Improving the learning process in education will empower medical students, and also formative assessment helps improve the teaching-learning process by providing ongoing reflective information about learning gaps.
OBJECTIVE


The aim of this study was to explore the effect of student-centered formative assessment by weekly reflective self-correction quizzes on medical laboratory students' performance on the final examination of hematology course in 2018.
MATERIALS AND METHODS


A semi-experimental study was conducted on fifty students divided randomly into intervention ( n  = 25) and control groups ( n  = 25) using convenience sampling in 2018 from Torbat Heydariyeh University of Medical Sciences, Iran. Data analysis was performed using SPSS software version 16, two-sample  t -test, Chi-square test, and analysis of covariance.
RESULTS


The intervention had positive effects on students' mean test scores in hematology II so that the intervention and control groups managed to obtain 18.45 ± 1.46 and 14.57 ± 2.64, respectively ( P  < 0.01).
CONCLUSIONS


The results suggested that weekly formative assessments along with reflective self-correction activity and active participation of students in the learning process by designing questions could improve student learning.",2020,"The intervention had positive effects on students' mean test scores in hematology II so that the intervention and control groups managed to obtain 18.45 ± 1.46 and 14.57 ± 2.64, respectively ( P  < 0.01).
","[""students' performance"", ""medical laboratory students' performance on the final examination of hematology course in 2018"", 'A semi-experimental study was conducted on fifty students divided randomly into intervention ( n  = 25) and control groups ( n  = 25) using convenience sampling in 2018 from Torbat Heydariyeh University of Medical Sciences, Iran']","['student-centered formative assessment', 'student-centered formative assessment by weekly reflective self-correction quizzes']",['student learning'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",50.0,0.0247571,"The intervention had positive effects on students' mean test scores in hematology II so that the intervention and control groups managed to obtain 18.45 ± 1.46 and 14.57 ± 2.64, respectively ( P  < 0.01).
","[{'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Shahedi', 'Affiliation': 'Department of Radiology, School of Paramedical Sciences, Torbat Heydariyeh University of Medical Sciences, Torbat Heydariyeh, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Ahmadi', 'Affiliation': 'Health Sciences Research Center, Torbat Heydariyeh University of Medical Sciences, Torbat Heydariyeh, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Sharifi', 'Affiliation': 'Department of Health Care Management, School of Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyedeh Nahid', 'Initials': 'SN', 'LastName': 'Seyedhasani', 'Affiliation': 'Health Sciences Research Center, Torbat Heydariyeh University of Medical Sciences, Torbat Heydariyeh, Iran.'}, {'ForeName': 'Mahbubeh', 'Initials': 'M', 'LastName': 'Abdollahi', 'Affiliation': 'Health Sciences Research Center, Torbat Heydariyeh University of Medical Sciences, Torbat Heydariyeh, Iran.'}, {'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Shaabani', 'Affiliation': 'Student Research Committee, Torbat Heydariyeh University of Medical Sciences, Torbat Heydariyeh, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sarmadi', 'Affiliation': 'Health Sciences Research Center, Torbat Heydariyeh University of Medical Sciences, Torbat Heydariyeh, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_753_19']
1752,32766322,Enhancing academic engagement of underachieving gifted students: The effects of Martin's educational program.,"INTRODUCTION


Gifted students are superior to their peers in terms of cognitive, educational, scientific, creativity, and artistic abilities. There are also gifted students who struggle with cognitive, educational, social, emotional, and behavioral development, especially academic performance. They are called underachieving students. One of the main problems of these students is the low level of academic engagement in educational settings. Thus, this study investigated the effectiveness of Martin's educational program on academic engagement (behavioral, emotional, cognitive, and agency) of underachieving gifted students.
MATERIALS AND METHODS


Thirty underachieving gifted students were selected by purposeful sampling from a high school in Isfahan, Iran, and were divided randomly into the experimental ( n  = 15) and the control ( n  = 15) groups. All participants completed the students' academic engagement questionnaire (behavioral engagement, emotional engagement, cognitive engagement, and agency engagement) at pre/post-test.
RESULTS


The findings showed that Martin's cognitive-behavioral program had a significant effect on academic engagement and its subscales, including behavioral engagement, emotional engagement, cognitive engagement, and agency engagement.
CONCLUSION


School counselors could benefit Martin's cognitive-behavioral program to promote the academic engagement of underachieving gifted students.",2020,"All participants completed the students' academic engagement questionnaire (behavioral engagement, emotional engagement, cognitive engagement, and agency engagement) at pre/post-test.
","['underachieving gifted students', 'Thirty underachieving gifted students were selected by purposeful sampling from a high school in Isfahan, Iran']","[""Martin's educational program""]","[""students' academic engagement questionnaire (behavioral engagement, emotional engagement, cognitive engagement, and agency engagement"", 'academic engagement (behavioral, emotional, cognitive, and agency', 'academic engagement and its subscales, including behavioral engagement, emotional engagement, cognitive engagement, and agency engagement']","[{'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",,0.0153828,"All participants completed the students' academic engagement questionnaire (behavioral engagement, emotional engagement, cognitive engagement, and agency engagement) at pre/post-test.
","[{'ForeName': 'Meadeh', 'Initials': 'M', 'LastName': 'Hesam', 'Affiliation': 'Master of Counseling in Yazd Science and Research Branch of The Islamic Azad University, Yazd, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Abedi', 'Affiliation': 'Department of Children with Special Needs, University of Isfahan, Isfahan, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_715_19']
1753,32766327,Effectiveness of school-based mental health programs on mental health among adolescents.,"AIM


This study aimed to investigate the effect of school-based interventions on mental health among adolescents in the southeast of Iran.
METHODS


This interventional quasi-experimental study included a total of 420 adolescent girls studying 10 th  grade in the public schools of Zahedan, Iran. Data were collected using general health questionnaire-28 questionnaire. After pretest, multidimensional interventions (individual education, group education, individual consultations, modern education, and parents' educational packages) were given to the intervention group from October 2015 to June 2016. After a 3-month interval, the posttest was conducted in October 2016. Data were analyzed by covariance analysis.
RESULTS


There was a significant statistical difference between the changes in the mental health scores after the intervention among the two study groups ( P  < 0.05). Furthermore, after the intervention, moderate-to-severe mental health problems decreased considerably among the students in the intervention group compared to controls. The greatest impact was on individual psychological counseling.
CONCLUSIONS


The results of the study showed that by applying group training and individual counseling in the schools improves mental health. Therefore, identifying student problems and parent-teacher cooperation as well as consulting with specialist counselors can be effective in providing practical and effective solutions in this regard. Therefore, findings suggest that prioritizing mental health and taking action on the field are of utmost importance.",2020,"Furthermore, after the intervention, moderate-to-severe mental health problems decreased considerably among the students in the intervention group compared to controls.","['mental health among adolescents', '420 adolescent girls studying 10 th  grade in the public schools of Zahedan, Iran', 'mental health among adolescents in the southeast of Iran']","['school-based interventions', ""multidimensional interventions (individual education, group education, individual consultations, modern education, and parents' educational packages"", 'school-based mental health programs']","['mental health', 'mental health scores', 'moderate-to-severe mental health problems']","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}]",420.0,0.0214979,"Furthermore, after the intervention, moderate-to-severe mental health problems decreased considerably among the students in the intervention group compared to controls.","[{'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Shahraki-Sanavi', 'Affiliation': 'Department of Public Health and Health Promotion Research Center, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ansari-Moghaddam', 'Affiliation': 'Department of Epidemiology and Biostatistics, Health Promotion Research Center, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Epidemiology and Biostatistics, Health Promotion Research Center, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Nour-Mohammad', 'Initials': 'NM', 'LastName': 'Bakhshani', 'Affiliation': 'Department of Psychiatric and Clinical Psychology, Children and Adolescents Health Research Center, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Salehiniya', 'Affiliation': 'Social Determinants of Health Research Center, Birjand University of Medical Sciences, Birjand, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_421_19']
1754,32766331,The effect of empowerment program based on the social cognitive theory on the activity of daily living in patients with chronic obstructive pulmonary disease.,"OBJECTIVE AND AIM


Chronic obstructive pulmonary disease (COPD) is one of the most common chronic diseases. The patient's fear and anxiety of shortness of breath and coughing during exercise may lead to a decrease in patients' daily activities. Therefore, the present study aimed to determine the effect of empowerment program based on the social cognitive theory (SCT) on the daily activity of patients with COPD.
METHODS


This quasi-experimental study was performed on 70 patients with COPD referred to Kashani and Hajar centers in 2019. Samples were randomly divided into two groups of experimental and control. Data collection tools included demographic information questionnaire and activity of daily living questionnaire, specific for COPD, and a researcher-made questionnaire for measuring SCT constructs. For the experimental group, the training program consisted of four theoretical and practical sessions of 40 min/week. The data were collected at three time points, before, immediately and 3 months after the training are 3 time. The data were analyzed by SPSS software using descriptive and inferential statistics.
RESULTS


The difference between the mean scores of behavioral ability, self-efficacy, and empowerment in the three stages was significant only in the experimental group ( P  < 0.001). The mean daily activity score of patients before, immediately, and 3 months after intervention showed a statistically significant difference between the two groups (52.46 ± 21.98, 63.36 ± 21.95, and 71.34 ± 19.02), respectively, in the intervention group, and (51.79 ± 19.29, 53.70 ± 19.28, and 53.82 ± 19.26), respectively, in the control group ( P  < 0.001).
CONCLUSION


The results of this study showed that empowerment of patients through interventions based on SCT can increase the daily activity of patients with COPD. Because nurses play an important role in patient education and improvement, it is hoped that the findings of this study will be used as a strategy to increase the daily activity and ultimately improve the quality of life in these patients.",2020,"The difference between the mean scores of behavioral ability, self-efficacy, and empowerment in the three stages was significant only in the experimental group ( P  < 0.001).","['Chronic obstructive pulmonary disease (COPD', '70 patients with COPD referred to Kashani and Hajar centers in 2019', 'patients with chronic obstructive pulmonary disease', 'patients with COPD', 'patients with COPD.\nMETHODS']","['SCT', 'empowerment program', 'social cognitive theory (SCT']","['quality of life', 'demographic information questionnaire and activity of daily living questionnaire, specific for COPD', ""patient's fear and anxiety of shortness of breath and coughing"", 'daily activity', 'mean scores of behavioral ability, self-efficacy, and empowerment', 'mean daily activity score']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]",70.0,0.0366156,"The difference between the mean scores of behavioral ability, self-efficacy, and empowerment in the three stages was significant only in the experimental group ( P  < 0.001).","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Aliakbari', 'Affiliation': 'Community Oriented Nursing Midwifery Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}, {'ForeName': 'Forouzan Mohammad', 'Initials': 'FM', 'LastName': 'Alipour', 'Affiliation': 'Community Oriented Nursing Midwifery Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Tavassoli', 'Affiliation': 'Health School, Shahrekord University of Medical Science, Shahrekord, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Sedehi', 'Affiliation': 'Health School, Shahrekord University of Medical Science, Shahrekord, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_752_19']
1755,32766383,Five-Day vs 10-Day Postexposure Chemoprophylaxis With Oseltamivir to Prevent Hospital Transmission of Influenza: A Noninferiority Randomized Open-Label Study.,"Background


The efficacy and optimal duration of postexposure influenza prophylaxis with oseltamivir are undetermined in hospital settings, where immediate separation from index cases is not feasible.
Methods


In an open-label noninferiority randomized clinical trial in a single-center university hospital, the efficacy of 5-day vs 10-day postexposure prophylaxis with oseltamivir was compared in adult patients exposed to influenza who could not be immediately separated from index influenza cases. Influenza incidence was assessed for 10 days after discontinuing prophylaxis.
Results


Among 222 exposed patients (median age, 75 years; male 119; median Charlson Comorbidity Index, 5), 110 patients were assigned to 5 days of postexposure prophylaxis with oseltamivir, and 112 patients were assigned to the 10-day group. The median duration of exposure to influenza (interquartile range) was 2 (1-3) days. In the intention-to-treat analysis, the incidence of influenza was 2/110 (1.8%) in the 5-day group and 0/112 (0%) in the 10-day group (difference, 1.8 percentage points; 1-sided 95% CI, -1 to 4.9 percentage points;  P  = .77).
Conclusions


For patients exposed to influenza in a hospital setting and who were not immediately separated from index cases, postexposure prophylaxis with oseltamivir resulted in low incidence of nosocomial influenza transmission. Five-day postexposure prophylaxis was noninferior to 10-day regimen.
ClinicalTrialsgov Registration


NCT03899571.",2020,"In the intention-to-treat analysis, the incidence of influenza was 2/110 (1.8%) in the 5-day group and 0/112 (0%) in the 10-day group (difference, 1.8 percentage points; 1-sided 95% CI, -1 to 4.9 percentage points;  P  = .77).
","['adult patients exposed to influenza who could not be immediately separated from index influenza cases', 'male 119; median Charlson Comorbidity Index, 5', '222 exposed patients (median age, 75 years', '110 patients']","['5-day vs 10-day postexposure prophylaxis with oseltamivir', 'Five-Day vs 10-Day Postexposure Chemoprophylaxis', 'postexposure prophylaxis with oseltamivir', 'Oseltamivir']","['Influenza incidence', 'Hospital Transmission of Influenza', 'median duration of exposure to influenza', 'incidence of influenza']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}]","[{'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]",222.0,0.0744068,"In the intention-to-treat analysis, the incidence of influenza was 2/110 (1.8%) in the 5-day group and 0/112 (0%) in the 10-day group (difference, 1.8 percentage points; 1-sided 95% CI, -1 to 4.9 percentage points;  P  = .77).
","[{'ForeName': 'Lidija', 'Initials': 'L', 'LastName': 'Lepen', 'Affiliation': 'Department of Infectious Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Rok', 'Initials': 'R', 'LastName': 'Blagus', 'Affiliation': 'Institute for Biostatistics and Medical Informatics, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Maša', 'Initials': 'M', 'LastName': 'Velušček', 'Affiliation': 'Department of Infectious Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Rajko', 'Initials': 'R', 'LastName': 'Saletinger', 'Affiliation': 'Department of Infectious Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Miroslav', 'Initials': 'M', 'LastName': 'Petrovec', 'Affiliation': 'Institute for Microbiology and Immunology Ljubljana, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Fajko F', 'Initials': 'FF', 'LastName': 'Bajrović', 'Affiliation': 'Department of Neurology, University Medical Center Ljubljana, Ljubljana, Slovenia and Institute of Pathophysiology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Daša', 'Initials': 'D', 'LastName': 'Stupica', 'Affiliation': 'Department of Infectious Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia.'}]",Open forum infectious diseases,['10.1093/ofid/ofaa240']
1756,32766392,Intra-articular versus Intravenous Tranexamic Acid in Total Knee Arthroplasty: A Randomized Clinical Trial.,"Background


Total knee arthroplasty (TKA) can cause excessive blood loss requiring allogenic transfusions. Tranexamic acid (TXA) has been increasingly used for lowering blood loss. The present study aimed to compare the efficacy of intravenous (IV) and intra-articular (IA) administrations of TXA in TKA patients who receive aspirin as chemoprophylaxis and uses no drain post-operative.
Methods


In this prospective randomized clinical trial, 49 TKA patients were intravenously given 15 mg/kg dose of TXA, and 49 patients intraarticularly received 15 mg/kg of TXA. Demographic information, pre-operative and post-operative hemoglobin values of the patients were used for assessing total perioperative blood loss by GOOD & NADLER formulae.
Results


There was not any significant difference between the IV TXA and IA TXA groups concerning blood loss ( P=0.102 ). However, the decrease in hemoglobin level at 48 hours post-operation compared to the preoperative level in the IV TXA group was significantly higher than that in the IA TXA group (-2.3 ±0.8 vs. -1.9 ±1.0 g/dL;  P=0.038 ). No blood transfusion was needed, and the deep venous thrombosis and pulmonary embolization were not observed in either of the groups ( P>0.05 ).
Conclusion


Our study showed that during TKA, the IA TXA is equally safe and effective as its IV infusion concerning decreased blood loss and adverse effects. The use of TXA during TKA is safe for patients who receive less potent chemoprophylaxis agents such as aspirin.",2020,There was not any significant difference between the IV TXA and IA TXA groups concerning blood loss ( P=0.102 ).,"['Total Knee Arthroplasty', 'TKA patients who receive aspirin as chemoprophylaxis and uses no drain post-operative', '49 TKA patients', 'patients who receive less potent chemoprophylaxis agents such as aspirin']","['TXA', 'IA TXA', '\n\n\nTotal knee arthroplasty (TKA', 'Tranexamic acid (TXA', 'intravenous (IV) and intra-articular (IA) administrations of TXA', 'Intra-articular versus Intravenous Tranexamic Acid']","['Demographic information, pre-operative and post-operative hemoglobin values', 'deep venous thrombosis and pulmonary embolization', 'hemoglobin level', 'blood loss and adverse effects', 'blood transfusion', 'blood loss']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",49.0,0.040391,There was not any significant difference between the IV TXA and IA TXA groups concerning blood loss ( P=0.102 ).,"[{'ForeName': 'Sm Javad', 'Initials': 'SJ', 'LastName': 'Mortazavi', 'Affiliation': 'Joint Reconstruction Research Center, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Sattartabar', 'Affiliation': 'Joint Reconstruction Research Center, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Moharrami', 'Affiliation': 'Joint Reconstruction Research Center, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Seyed Hadi', 'Initials': 'SH', 'LastName': 'Kalantar', 'Affiliation': 'Joint Reconstruction Research Center, Tehran University of Medical Science, Tehran, Iran.'}]",The archives of bone and joint surgery,['10.22038/abjs.2019.39080.2039']
1757,32766393,The Efficacy of Intravenous Versus Topical Use of Tranexamic Acid in Reducing Blood Loss after Primary Total Knee Arthroplasty: A Randomized Clinical Trial.,"Background


Blood loss during and immediately after total knee arthroplasty (TKA) is among the most challenging concerns. It has been demonstrated that Tranexamic acid (TXA) can help to reduce perioperative blood loss. TXA can be used as an oral, topical or intravenous injection. Many studies evaluated the effectiveness of each route of administration but few works on a comparison between them. The current study aimed to compare the effectiveness of intravenous injection versus topical use of TXA in reducing perioperative blood loss after primary total knee arthroplasty.
Methods


Eighty-five patients who were a candidate for total knee arthroplasty were randomized into two groups: one group received Intravenous injection of 15 mg/kg TXA, 10 min before tourniquet inflation while the other group received 1 g diluted TXA during wound closure. The postoperative blood loss was estimated by measuring the whole drain output and also hemoglobin (HB) drops. Both groups compared based on the need for allogenic blood transfusion and also thromboembolic events.
Results


Patients who received topical TXA had a higher total drain output ( p   <0.0001 ) compared to intravenous injection. The hemoglobin drop also was more in the topical group although it was marginally significant ( p   =0.05 ).
Conclusion


Intravenous injection of TXA is more effective in reducing postoperative blood loss after primary TKA compared to topical administration.",2020,"Results


Patients who received topical TXA had a higher total drain output ( p   <0.0001 ) compared to intravenous injection.","['after Primary Total Knee Arthroplasty', 'primary total knee arthroplasty', 'Methods\n\n\nEighty-five patients who were a candidate for total knee arthroplasty']","['TXA', 'Intravenous injection of 15 mg/kg TXA, 10 min before tourniquet inflation while the other group received 1 g diluted TXA', 'topical TXA', 'Tranexamic Acid', 'Tranexamic acid (TXA']","['postoperative blood loss', 'perioperative blood loss', 'Blood Loss', 'total drain output']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0021494', 'cui_str': 'Intravenous injection'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}]",85.0,0.044701,"Results


Patients who received topical TXA had a higher total drain output ( p   <0.0001 ) compared to intravenous injection.","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Torkaman', 'Affiliation': 'epartment of Knee Surgery, Firouzgar Hospital, Iran University of Medical Sciences,Tehran , Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Rostami', 'Affiliation': 'Bone and Joint Reconstruction Research Center, Firouzgar Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Sarshar', 'Affiliation': 'Bone and Joint Reconstruction Research Center, Shafa Orthopedic Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Akbari Aghdam', 'Affiliation': 'Department of Orthopedic Surgery, School of Medicine, Isfahan University of Medical Sciences , Isfahan, Iran.'}, {'ForeName': 'Paniz', 'Initials': 'P', 'LastName': 'Motaghi', 'Affiliation': 'Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Yazdi', 'Affiliation': 'Bone and Joint Reconstruction Research Center, Firouzgar Hospital, Iran University of edical ciences, Tehran, Iran.'}]",The archives of bone and joint surgery,['10.22038/abjs.2020.40528.2099']
1758,32766402,Modified Camitz versus BRAND Procedures for the Treatment of Severe Carpal Tunnel Syndrome: A Comparative Trial Study.,"Background


Carpal tunnel syndrome (CTS) is characterized by complications such as pain, paresthesia, and numbness in the fingers. There are some surgical therapies for the management of severe carpal tunnel, but differences exist between the treatments available for creating the opposition. The current study was conducted to compare the effect of modified Camitz and BRAND techniques on thumb opposition in patients with severe CTS.
Methods


A total of 40 patients with severe CTS who were candidates for opponensplasty were enrolled in this clinical trial study at Alzahra and Kashani hospitals, Isfahan, Iran, from 2014 to 2018. The patients were divided into two groups of modified Camitz and BRAND. Quick DASH-9 and Kapandji scores as well as pulp and side pinch and pronation angle were assessed before and after the surgeries.
Results


Quick DASH-9 score, Kapandji score, pulp and side pinch and pronation angle significantly improved post-operatively ( P=0.0XXX ,  P=0.0XXX ,  P=0.0XXX ,  P=0.0XXX , and  P=0.0XXX , respectively). But, no significant differences were seen in the mentioned variables between both groups pre and post-operative ( P>0.05 , for all the studied variables). No postsurgical complications were seen in any of the groups.
Conclusion


The findings of the present study demonstrated that, both Modified Camitz and BRAND techniques are effective and safe techniques, yielding high improvements, but no serious complications. Both techniques can be considered for treatment of patients with severe CTS.",2020,"Results


Quick DASH-9 score, Kapandji score, pulp and side pinch and pronation angle significantly improved post-operatively ( P=0.0XXX ,  P=0.0XXX ,  P=0.0XXX ,  P=0.0XXX , and  P=0.0XXX , respectively).","['40 patients with severe CTS who were candidates for opponensplasty were enrolled in this clinical trial study at Alzahra and Kashani hospitals, Isfahan, Iran, from 2014 to 2018', 'patients with severe CTS', 'Severe Carpal Tunnel Syndrome']","['modified Camitz and BRAND techniques', 'Modified Camitz versus BRAND Procedures', 'modified Camitz and BRAND']","['postsurgical complications', 'Quick DASH-9 and Kapandji scores', 'Quick DASH-9 score, Kapandji score, pulp and side pinch and pronation angle']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0418416', 'cui_str': 'Pinched'}, {'cui': 'C0033421', 'cui_str': 'Pronation'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]",40.0,0.0195449,"Results


Quick DASH-9 score, Kapandji score, pulp and side pinch and pronation angle significantly improved post-operatively ( P=0.0XXX ,  P=0.0XXX ,  P=0.0XXX ,  P=0.0XXX , and  P=0.0XXX , respectively).","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Dehghani', 'Affiliation': 'Department of Orthopedic, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Behrooz', 'Initials': 'B', 'LastName': 'Fadaei', 'Affiliation': 'Department of Orthopedic, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Shirvan', 'Initials': 'S', 'LastName': 'Rastegar', 'Affiliation': 'Department of Orthopedic, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Abolghasem', 'Initials': 'A', 'LastName': 'Zarezadeh', 'Affiliation': 'Department of Orthopedic, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Keyvan', 'Initials': 'K', 'LastName': 'Ghadimi', 'Affiliation': 'School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Roham', 'Initials': 'R', 'LastName': 'Nikkhah', 'Affiliation': 'School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Eslami', 'Affiliation': 'Department of Orthopedic, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",The archives of bone and joint surgery,['10.22038/abjs.2019.14127']
1759,32766521,Canal Transportation and Centring Ability of Reciproc and Reciproc Blue With or Without Use of Glide Path Instruments: A CBCT Study.,"Objective


The objective of this ex vivo study was to evaluate canal transportation and centring ability of Reciproc and Reciproc blue systems in curved root canals with or without prior use of PathFile rotary system (PF) using Cone Beam Computed Tomography (CBCT).
Methods


One hundred and twenty curved root canals from maxillary and mandibular premolars were selected. Canals were divided randomly into 4 groups (n=30): Reciproc 25 (R25), (PF+R25), Reciproc Blue 25 (RB25), (PF+RB 25). Specimens were scanned before and after root canal preparation. Using CBCT, root canal transportation and centring ability was assessed by measuring the shortest distance from the edge of uninstrumented canal to the periphery of the root (mesial and distal) before and after preparation. Data were analysed using a one-way analysis of variance and Tukey test. The p value was set at 0.05.
Results


Less transportation and better centring ability occurred when PF was used before R25 or RB25 (P<0.0001). There was no significant difference between R25 and RB25 groups.
Conclusion


Using PF before R25 and RB25 resulted in less root canal transportation and better centring ability. The specific thermo-mechanical treatment of RB25 did not provide better results when compared to R25.",2020,Less transportation and better centring ability occurred when PF was used before R25 or RB25 (P<0.0001).,['Methods\n\n\nOne hundred and twenty curved root canals from maxillary and mandibular premolars were selected'],"['PathFile rotary system (PF) using Cone Beam Computed Tomography (CBCT', 'Reciproc and Reciproc Blue']","['CBCT, root canal transportation and centring ability', 'root canal transportation and better centring ability', 'Less transportation and better centring ability', 'Reciproc 25 (R25), (PF+R25), Reciproc Blue 25 (RB25), (PF+RB 25']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205133', 'cui_str': 'Bent'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}]","[{'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}]",,0.0238687,Less transportation and better centring ability occurred when PF was used before R25 or RB25 (P<0.0001).,"[{'ForeName': 'Wajih', 'Initials': 'W', 'LastName': 'Hage', 'Affiliation': 'Department of Endodontics, School of Dentistry, Saint Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Zogheib', 'Affiliation': 'Department of Endodontics, School of Dentistry, Saint Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Bukiet', 'Affiliation': 'Department of Odontology, Aix Marseille Univ, CNRS, ISM, Inst Movement Sci, Marseille, France; APHM, Timone Hospital, Marseille, France.'}, {'ForeName': 'Germain', 'Initials': 'G', 'LastName': 'Sfeir', 'Affiliation': 'Department of Endodontics, School of Dentistry, Saint Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Issam', 'Initials': 'I', 'LastName': 'Khalil', 'Affiliation': 'Department of Endodontics, School of Dentistry, Saint Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gergi', 'Affiliation': 'Department of Endodontics, School of Dentistry, Saint Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Naaman', 'Affiliation': 'Department of Endodontics, School of Dentistry, Saint Joseph University, Beirut, Lebanon.'}]",European endodontic journal,['10.14744/eej.2019.86570']
1760,32766527,Effect of Gravity on Periapical Extrusion of Irrigating Solution With Different Irrigation Protocols in Immature Anterior Teeth.,"Objective


Periapical extrusion is frequently observed during endodontic therapy. It can lead to acute injury of periapical tissues, resulting in interappointment pain or swelling. The effect is pronounced in teeth with immature teeth which are more susceptible to the extrusion of irrigant. The aim of this study was to evaluate the effect of gravity on apical extrusion of irrigating solution with different irrigation protocols in immature anterior teeth.
Methods


An extracted maxillary central incisor was modified to simulate an open apex with an apical diameter of 1.3 mm and parallel canal walls. The tooth was subjected to a cone-beam computed tomographic scan, and the image data set was utilized to prepare 30 resin tooth models with a 3D printer. These resin teeth were used to form an open-ended Myers and Montgomery extrusion models. These were then randomly divided into two groups to simulate their orientation in the jaw during endodontic therapy, i.e., group I (maxillary arch, n=15) models fixed at 45° inclined plane and group II (mandibular arch, n=15) models placed at a plane parallel to the floor. Five models from each group (n=5) were tested by three different irrigation protocols: positive pressure (PP) Irrigation, passive ultrasonic irrigation (PUI), and negative pressure (NP) irrigation. The extruded irrigating solution was collected in glass vials, and the volume was measured.
Results


The volume of extruded irrigating solution in groups I and II was compared using Mann-Whitney U-test. The median values for PP, PUI, and NP irrigation protocols were 0.6, 1, and 0 ml and 10, 10, and 0.5 ml for groups I and II, respectively. PP and PUI protocols were associated with significantly less extrusion in group I when compared to group II (P=0.004). There was no statistically significant difference in the volume of irrigating solution extruded in groups I and II (P=0.007) for NP irrigation protocol.
Conclusion


Gravitation force has an influence on periapical extrusion of irrigant in immature permanent teeth irrespective of the irrigant system used. NP performed better when compared to PP or PUI irrigation protocol irrespective of the tooth orientation.",2020,PP and PUI protocols were associated with significantly less extrusion in group,"['immature anterior teeth', 'Immature Anterior Teeth']","['irrigation protocols: positive pressure (PP) Irrigation, passive ultrasonic irrigation (PUI), and negative pressure (NP) irrigation', 'models fixed at 45° inclined plane and group II (mandibular arch, n=15) models placed at a plane parallel to the floor']","['median values for PP, PUI, and NP irrigation protocols', 'volume of irrigating solution']","[{'cui': 'C0205252', 'cui_str': 'Immature'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231063', 'cui_str': 'First branchial arch structure'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0593225', 'cui_str': 'Solution for irrigation'}]",,0.0289705,PP and PUI protocols were associated with significantly less extrusion in group,"[{'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Division of Conservative Dentistry and Endodontics Centre, Dental Education and Research All India Institute of Medical Sciences New Delhi, India.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Division of Conservative Dentistry and Endodontics Centre, Dental Education and Research All India Institute of Medical Sciences New Delhi, India.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Logani', 'Affiliation': 'Division of Conservative Dentistry and Endodontics Centre, Dental Education and Research All India Institute of Medical Sciences New Delhi, India.'}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Chawla', 'Affiliation': 'Division of Conservative Dentistry and Endodontics Centre, Dental Education and Research All India Institute of Medical Sciences New Delhi, India.'}, {'ForeName': 'Sidhartha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Division of Conservative Dentistry and Endodontics Centre, Dental Education and Research All India Institute of Medical Sciences New Delhi, India.'}, {'ForeName': 'Bhawna', 'Initials': 'B', 'LastName': 'Koli', 'Affiliation': 'Division of Conservative Dentistry and Endodontics Centre, Dental Education and Research All India Institute of Medical Sciences New Delhi, India.'}]",European endodontic journal,['10.14744/eej.2020.20592']
1761,32766563,Leveraging Tele-Critical Care Capabilities for Clinical Trial Consent.,"A severe coronavirus disease 2019 patient admitted to our institution for medical management was enrolled in a randomized placebo-controlled trial of an investigational therapeutic for coronavirus disease 2019. We leveraged existing video-telecommunication equipment to obtain informed consent. We found video-telecommunication use closely mirrored person-to-person contact for research consent by maintaining engagement and ensuring understanding. Video-telecommunication use facilitated clinical research while minimizing unnecessary exposure to coronavirus disease 2019 and conserving personal protective equipment. Prior to the coronavirus disease 2019 pandemic, research regulatory agencies were essentially silent on the matter of video-telecommunication consent. Regulatory guidance became available during the pandemic in response to increased isolation and social distancing practices. Virtual health and telemedicine use expanded greatly during the pandemic, and this increase will likely persist after the pandemic ends. We anticipate video-telecommunication adoption and implementation for research consent will also continue to grow after the coronavirus disease 2019 pandemic is over.",2020,"Prior to the coronavirus disease 2019 pandemic, research regulatory agencies were essentially silent on the matter of video-telecommunication consent.",['A severe coronavirus disease 2019 patient admitted to our institution for medical management'],['placebo'],[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.031852,"Prior to the coronavirus disease 2019 pandemic, research regulatory agencies were essentially silent on the matter of video-telecommunication consent.","[{'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Ieronimakis', 'Affiliation': 'Madigan Army Medical Center, Tacoma, WA.'}, {'ForeName': 'Janell A', 'Initials': 'JA', 'LastName': 'Cain', 'Affiliation': 'Madigan Army Medical Center, Tacoma, WA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Switzer', 'Affiliation': 'Madigan Army Medical Center, Tacoma, WA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Odineal', 'Affiliation': 'Madigan Army Medical Center, Tacoma, WA.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Deacy', 'Affiliation': 'Madigan Army Medical Center, Tacoma, WA.'}, {'ForeName': 'Michael T O', 'Initials': 'MTO', 'LastName': 'Stein', 'Affiliation': 'Madigan Army Medical Center, Tacoma, WA.'}, {'ForeName': 'Rhonda E', 'Initials': 'RE', 'LastName': 'Colombo', 'Affiliation': 'Madigan Army Medical Center, Tacoma, WA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Colombo', 'Affiliation': 'Madigan Army Medical Center, Tacoma, WA.'}]",Critical care explorations,['10.1097/CCE.0000000000000167']
1762,32766747,Short-Term Changes in the Photopic Negative Response Following Intraocular Pressure Lowering in Glaucoma.,"Purpose


To evaluate the short-term changes in inner retinal function using the photopic negative response (PhNR) after intraocular pressure (IOP) reduction in glaucoma.
Methods


Forty-seven participants with glaucoma who were commencing a new or additional IOP-lowering therapy (treatment group) and 39 participants with stable glaucoma (control group) were recruited. IOP, visual field, retinal nerve fiber layer thickness, and electroretinograms (ERGs) were recorded at baseline and at a follow-up visit (3 ± 2 months). An optimized protocol developed for a portable ERG device was used to record the PhNR. The PhNR saturated amplitude (Vmax), Vmax ratio, semi-saturation constant (K), and slope of the Naka-Rushton function were analyzed.
Results


A significant percentage reduction in IOP was observed in the treatment group (28 ± 3%) compared to the control group (2 ± 3%; P < 0.0001). For PhNR Vmax, there was no significant interaction (F1,83 = 2.099, P = 0.15), but there was a significant difference between the two time points (F1,83 = 5.689, P = 0.019). Post hoc analysis showed a significant difference between baseline and 3 months in the treatment group (mean difference, 1.23 µV; 95% confidence interval [CI], 0.24-2.22) but not in the control group (0.30 µV; 95% CI, 0.78-1.38). K and slope were not significantly different in either group. Improvement beyond test-retest variability was seen in 17% of participants in the treatment group compared to 3% in the control group (P = 0.007, χ2 test).
Conclusions


The optimized protocol for measuring the PhNR detected short-term improvements in a proportion of participants following IOP reduction, although the majority showed no change.",2020,A significant percentage reduction in IOP was observed in the treatment group (28 ± 3%) compared to the control group (2 ± 3%; P < 0.0001).,"['Glaucoma', 'Methods\n\n\nForty-seven participants with glaucoma who were commencing a new or additional IOP-lowering therapy (treatment group) and 39 participants with stable glaucoma (control group) were recruited', 'glaucoma']",['photopic negative response (PhNR) after intraocular pressure (IOP'],"['Improvement beyond test-retest variability', 'K and slope', 'Photopic Negative Response', 'IOP, visual field, retinal nerve fiber layer thickness, and electroretinograms (ERGs', 'IOP', 'PhNR saturated amplitude (Vmax), Vmax ratio, semi-saturation constant (K), and slope of the Naka-Rushton function']","[{'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0013867', 'cui_str': 'Electroretinography'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",47.0,0.0895277,A significant percentage reduction in IOP was observed in the treatment group (28 ± 3%) compared to the control group (2 ± 3%; P < 0.0001).,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Glaucoma Research Unit, Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Hui', 'Affiliation': 'Glaucoma Research Unit, Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Hadoux', 'Affiliation': 'Glaucoma Research Unit, Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Soares', 'Affiliation': 'Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jamieson', 'Affiliation': 'Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'van Wijngaarden', 'Affiliation': 'Glaucoma Research Unit, Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Coote', 'Affiliation': 'Glaucoma Research Unit, Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Crowston', 'Affiliation': 'Glaucoma Research Unit, Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}]",Investigative ophthalmology & visual science,['10.1167/iovs.61.10.16']
1763,32766852,"In childhood mature B-NHL with CNS disease, patients with blasts in cerebrospinal fluid are at higher risk of failure.","To identify the factors influencing outcome in childhood mature B-cell non-Hodgkin lymphoma and acute leukemia (B-NHL/AL) with central nervous system (CNS) disease (CNS+), we analyzed patients <18 years with newly diagnosed B-NHL/AL registered in 3 Lymphomes Malins B studies in France between 1989 to 2011. CNS+ was diagnosed on fulfillment of ≥1 of the following criteria: any L3 cerebrospinal fluid (CSF) blasts (CSF+), cranial nerve palsy, isolated intracerebral mass but also clinical spinal cord compression, and cranial or spinal parameningeal extension. Two hundred seventeen out of 1690 patients (12.8%) were CNS+. CNS+ was significantly associated with male gender, head/neck locations, Burkitt histology, high initial lactate dehydrogenase (LDH) level, and bone marrow involvement. CSF+ was the most frequent pattern of CNS+ (45%). For the 217 CNS+ patients, the 5-year event-free survival (EFS) and overall survival rates (95% confidence interval) were 81.5% (75.8% to 86.1%) and 83.9% (78.4% to 88.2%), respectively. In multivariate analysis, among CNS+ patients, low EFS was associated with CSF+, high initial LDH level, and poor response to cyclophosphamide, oncovin (vincristine), prednisone prephase. These findings have been considered for patient's stratification in the international randomized phase 3 trial Inter-B-NHL-ritux 2010 for children and adolescents with high-risk B-NHL/AL with CNS+ CSF+ patients only receiving intensified chemotherapy.",2020,"For the 217 CNS+ patients, the 5-year event-free survival (EFS) and overall survival rates (95% confidence interval) were 81.5% (75.8% to 86.1%) and 83.9% (78.4% to 88.2%), respectively.","['Two hundred seventeen out of 1690 patients (12.8%) were CNS', 'childhood mature B-cell non-Hodgkin lymphoma and acute leukemia (B-NHL/AL) with central nervous system (CNS) disease (CNS+), we analyzed patients <18 years with newly diagnosed B-NHL/AL registered in 3 Lymphomes Malins B studies in France between 1989 to 2011', 'children and adolescents with high-risk B-NHL/AL with CNS+ CSF+ patients only receiving intensified chemotherapy']","['CSF', 'CNS', 'cyclophosphamide, oncovin (vincristine), prednisone']","['male gender, head/neck locations, Burkitt histology, high initial lactate dehydrogenase (LDH) level, and bone marrow involvement', '5-year event-free survival (EFS) and overall survival rates']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517547', 'cui_str': '12.8'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0079731', 'cui_str': 'B-cell lymphoma (clinical)'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0591904', 'cui_str': 'Oncovine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",1690.0,0.0824711,"For the 217 CNS+ patients, the 5-year event-free survival (EFS) and overall survival rates (95% confidence interval) were 81.5% (75.8% to 86.1%) and 83.9% (78.4% to 88.2%), respectively.","[{'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Simonin', 'Affiliation': 'Department of Pediatric Oncology and Hematology, Armand Trousseau Hospital, Assistance Publique-Hôpitaux de Paris and Sorbonne University, Paris, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Auperin', 'Affiliation': 'Unit of Biostatistics and Epidemiology, Gustave Roussy, Paris-Saclay University, INSERM 1018, Villejuif, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Bertrand', 'Affiliation': 'Department of Pediatric Hematology, Institute of Pediatric Hematology and Oncology, Claude Bernard University Lyon, Paris, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Aladjidi', 'Affiliation': 'Department of Pediatric Oncology and Haematology, University Hospital of Bordeaux, Bordeaux, France.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Baruchel', 'Affiliation': 'Department of Pediatric Hematology and Immunology, Robert Debré Hospital, Assistance Publique-Hôpitaux de Paris and University Paris Diderot, Paris, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Contet', 'Affiliation': 'Department of Pediatric Onco-Hematology, University Hospital of Nancy, Nancy, France.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Coze', 'Affiliation': 'Department of Pediatric Hematology and Oncology, Timone Enfants Hospital, Assistance Publique-Hôpitaux de Marseille and Aix-Marseille University, Marseille, France.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Gandemer', 'Affiliation': 'Department of Pediatric Onco-Hematology, University Hospital of Rennes, University of Rennes 1, Rennes, France.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Haouy', 'Affiliation': 'Department of Pediatric Onco-Hematology, University Hospital of Montpellier, Montpellier, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Leblanc', 'Affiliation': 'Department of Pediatric Hematology and Immunology, Robert Debré Hospital, Assistance Publique-Hôpitaux de Paris and University Paris Diderot, Paris, France.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Leverger', 'Affiliation': 'Department of Pediatric Oncology and Hematology, Armand Trousseau Hospital, Assistance Publique-Hôpitaux de Paris and Sorbonne University, Paris, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Michon', 'Affiliation': 'Pediatric Oncology Unit, SIREDO, Institut Curie, Paris, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Patte', 'Affiliation': 'Department of Pediatric and Adolescent Oncology, Gustave Roussy, Paris-Saclay University, Villejuif, France; and.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Minard-Colin', 'Affiliation': 'Department of Pediatric and Adolescent Oncology, Gustave Roussy, Paris-Saclay University, Villejuif, France; and.'}]",Blood advances,['10.1182/bloodadvances.2019001398']
1764,32766863,Community delivery of brief therapy for depressed older adults impacted by Hurricane Sandy.,"Older adults frequently under-report depressive symptoms and often fail to access services after a disaster. To address unmet mental health needs, we developed a service delivery program (SMART-MH) that combines outreach, assessment, and therapy and implemented it in New York City after Hurricane Sandy. This study aimed to examine the feasibility, effectiveness, and patients' engagement of our brief psychotherapy (""Engage""). We predicted that Engage would result in reductions of depression, and that the benefits would be comparable to those of a historical comparison group who received Engage in a controlled experimental setting. A total of 2,831 adults (age ≥ 60) impacted by Hurricane Sandy were screened for depression. Assessments and therapy were conducted in English, Spanish, Cantonese, and Russian. Depressed individuals (PHQ-9 ≥ 10) who were not in treatment were offered Engage therapy in their native language at local senior center/nutrition sites. Twelve percent of the participants reported depression (N = 333). Of these 333 participants, 201 (60%) were not receiving treatment and 143 agreed to receive Engage therapy. Linear mixed-effects model showed that depression severity decreased significantly over time. More than two thirds had a five-point reduction in PHQ-9 scores and post-treatment scores ≤9. Post-hoc comparison of standardized slopes of change found patterns of depression reductions equivalent to Engage provided in a controlled setting. Partnerships to integrate mental health care into community settings can increase detection of mental-health needs and access to services in patients' native language. Brief reward exposure-based psychotherapy delivered in the community can provide comparable benefits to those achieved in research settings.",2020,More than two thirds had a five-point reduction in PHQ-9 scores and post-treatment scores ≤9.,"['depressed older adults impacted by Hurricane Sandy', '333 participants, 201 (60%) were not receiving treatment and 143 agreed to receive Engage therapy', 'Depressed individuals (PHQ-9 ≥ 10) who were not in treatment were offered Engage therapy in their native language at local senior center/nutrition sites', ""patients' native language"", 'Older adults', '2,831 adults (age ≥ 60) impacted by Hurricane Sandy were screened for depression']",['Brief reward exposure-based psychotherapy'],"['depression severity', 'PHQ-9 scores']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0020183', 'cui_str': 'Hurricane'}, {'cui': 'C4517724', 'cui_str': '333'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C3658240', 'cui_str': 'Centers for the Aged'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",2831.0,0.0336343,More than two thirds had a five-point reduction in PHQ-9 scores and post-treatment scores ≤9.,"[{'ForeName': 'Jo Anne', 'Initials': 'JA', 'LastName': 'Sirey', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, White Plains, NY, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Raue', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Nili', 'Initials': 'N', 'LastName': 'Solomonov', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, White Plains, NY, USA.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Scher', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, White Plains, NY, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Chalfin', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, White Plains, NY, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Zanotti', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, White Plains, NY, USA.'}, {'ForeName': 'Jacquelin', 'Initials': 'J', 'LastName': 'Berman', 'Affiliation': 'New York City Department for the Aging, New York, NY, USA.'}, {'ForeName': 'George S', 'Initials': 'GS', 'LastName': 'Alexopoulos', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, White Plains, NY, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibz145']
1765,32756825,Effectiveness of a handmade shell-based substrate for the breeding of Biomphalaria glabrata under laboratory conditions.,"Efficient snail production is essential for the proper maintenance of the Schistosoma mansoni life cycle in the laboratory. In order to improve the breeding of Biomphalaria glabrata under laboratory conditions, this study aimed to demonstrate the effectiveness of a handmade shell-based substrate on the physiological performance of B. glabrata. The shells used to make the substrate were cleaned, sterilized and macerated until a powder was obtained (yield of 92.3%). B. glabrata specimens were randomly assigned to three treatment groups: negative control group (NCG) exposed to a clay-only substrate; a positive control group (PCG) containing clay, oyster flour and calcium carbonate; and the test group (TG) with the shell-based substrate and clay. B. glabrata bred in the test group showed improved growth, sexual maturity, fertility, mortality rate, and shell morphology when compared to the NCG, and similar to the PCG. Therefore, the shell-based substrate proved to be efficient and has a low cost for the breeding of B. glabrata.",2020,"B. glabrata bred in the test group showed improved growth, sexual maturity, fertility, mortality rate, and shell morphology when compared to the NCG, and similar to the PCG.",['B. glabrata specimens'],"['handmade shell-based substrate', 'negative control group (NCG) exposed to a clay-only substrate; a positive control group (PCG) containing clay, oyster flour and calcium carbonate; and the test group (TG) with the shell-based substrate and clay']","['improved growth, sexual maturity, fertility, mortality rate, and shell morphology']","[{'cui': 'C0319899', 'cui_str': 'Candida glabrata'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0030104', 'cui_str': 'Oyster'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0233891', 'cui_str': 'Finding related to maturity of sexuality'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}]",,0.016931,"B. glabrata bred in the test group showed improved growth, sexual maturity, fertility, mortality rate, and shell morphology when compared to the NCG, and similar to the PCG.","[{'ForeName': 'João Gustavo Mendes', 'Initials': 'JGM', 'LastName': 'Rodrigues', 'Affiliation': 'Departamento de Parasitologia, Instituto de Ciências Biológicas, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Maria Gabriela Sampaio', 'Initials': 'MGS', 'LastName': 'Lira', 'Affiliation': 'Departamento de Patologia, Centro de Ciências Biológicas e da Saúde, Universidade Federal do Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Ranielly Araújo', 'Initials': 'RA', 'LastName': 'Nogueira', 'Affiliation': 'Departamento de Patologia, Centro de Ciências Biológicas e da Saúde, Universidade Federal do Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Gleycka Cristine Carvalho', 'Initials': 'GCC', 'LastName': 'Gomes', 'Affiliation': 'Departamento de Patologia, Centro de Ciências Biológicas e da Saúde, Universidade Federal do Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Irlla Correia Lima', 'Initials': 'ICL', 'LastName': 'Licá', 'Affiliation': 'Departamento de Patologia, Centro de Ciências Biológicas e da Saúde, Universidade Federal do Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Davi', 'Initials': 'D', 'LastName': 'Viegas-Melo', 'Affiliation': 'Laboratório de Parasitologia Humana, Departamento de Química e Biologia, Universidade Estadual do Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Teles-Reis', 'Affiliation': 'Laboratório de Parasitologia Humana, Departamento de Química e Biologia, Universidade Estadual do Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Guilherme Silva', 'Initials': 'GS', 'LastName': 'Miranda', 'Affiliation': 'Departamento de Parasitologia, Instituto de Ciências Biológicas, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Nêuton', 'Initials': 'N', 'LastName': 'Silva-Souza', 'Affiliation': 'Laboratório de Parasitologia Humana, Departamento de Química e Biologia, Universidade Estadual do Maranhão, São Luís, Maranhão, Brazil.'}]",Revista do Instituto de Medicina Tropical de Sao Paulo,['10.1590/s1678-9946202062055']
1766,32757437,"Collaborative care for the wearable cardioverter defibrillator patient: Getting the patient and medical team ""vested and active"".","Patients with a reduced ejection fraction of 35% or less and a history of myocardial infarction (MI) are at increased risk of sudden cardiac death (SCD). These patients have a class I indication for an implantable cardioverter-defibrillator after allowing time for medical therapy optimization and potential cardiac recovery. The rates of SCD are highest in this ""gap"" period early after a cardiac event, and the wearable cardioverter-defibrillator (WCD) is an intervention that can be used to protect against SCD during this time period. There has been a clinical trial that randomized patients with a reduced ejection fraction at the time of MI to a WCD versus control. Results of the trial showed no statistically significant difference in the primary endpoint of SCD. There are many intricacies to the interpretation of the trial, including the importance of patient adherence to WCD therapy, which is affected by the patient experience and psychological factors. Patients with a new cardiomyopathy are affected by a mix of psychological factors, including the feeling of safety and protection from a WCD contrasted by the WCD providing a reminder of awareness and fear of ventricular arrhythmias and SCD. Beyond the capabilities of a WCD to defibrillate a life-threatening ventricular arrhythmia, the device can also provide activity and heart failure diagnostics monitoring. Patients need to be engaged in shared decision-making conversations about a WCD, so that patients can make a decision based on their own values construct, ultimately increasing adherence among the patients that want a WCD.",2020,Results of the trial showed no statistically significant difference in the primary endpoint of SCD.,"['Wearable Cardioverter Defibrillator Patient', 'Patients with a reduced ejection fraction of 35% or less and a history of myocardial infarction']",['implantable cardioverter-defibrillator'],"['rates of SCD', 'SCD', 'risk of sudden cardiac death (SCD']","[{'cui': 'C0180307', 'cui_str': 'Defibrillator'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C1275835', 'cui_str': 'History of myocardial infarction'}]","[{'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}]","[{'cui': 'C0085298', 'cui_str': 'Sudden cardiac death'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0436581,Results of the trial showed no statistically significant difference in the primary endpoint of SCD.,"[{'ForeName': 'Samuel F', 'Initials': 'SF', 'LastName': 'Sears', 'Affiliation': 'Department of Psychology, East Carolina University, Greenville, North Carolina, USA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Tripp', 'Affiliation': 'Department of Psychology, East Carolina University, Greenville, North Carolina, USA.'}, {'ForeName': 'Nichelle L', 'Initials': 'NL', 'LastName': 'Huber', 'Affiliation': 'Department of Psychology, East Carolina University, Greenville, North Carolina, USA.'}, {'ForeName': 'Saleen', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Department of Cardiovascular Sciences, East Carolina University, Greenville, North Carolina, USA.'}, {'ForeName': 'Rajasekhar', 'Initials': 'R', 'LastName': 'Nekkanti', 'Affiliation': 'Department of Cardiovascular Sciences, East Carolina University, Greenville, North Carolina, USA.'}, {'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Burch', 'Affiliation': 'Department of Psychology, East Carolina University, Greenville, North Carolina, USA.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Pokorney', 'Affiliation': 'Division of Cardiology, Duke University, Durham, North Carolina, USA.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14708']
1767,32755413,Preconception Blood Pressure and Its Change Into Early Pregnancy: Early Risk Factors for Preeclampsia and Gestational Hypertension.,"Preeclampsia and gestational hypertension are common complications of pregnancy associated with significant maternal and infant morbidity. Despite extensive research evaluating risk factors during pregnancy, most women who develop a hypertensive disorder of pregnancy are not considered high-risk and strategies for prevention remain elusive. We evaluated preconception blood pressure and its change into early pregnancy as novel risk markers for development of a hypertensive disorder of pregnancy. The EAGeR (Effects of Aspirin in Gestation and Reproduction) trial (2007-2011) randomized 1228 healthy women with a history of pregnancy loss to preconception-initiated low-dose aspirin versus placebo and followed participants for up to 6 menstrual cycles attempting pregnancy and throughout pregnancy if they became pregnant. Blood pressure was measured during preconception and throughout early gestation. The primary outcomes, preterm preeclampsia, term preeclampsia, and gestational hypertension, were abstracted from medical records. Among 586 women with a pregnancy >20 weeks' gestation, preconception blood pressure levels were higher for preterm preeclampsia (87.3±6.7 mm Hg mean arterial pressure), term preeclampsia (88.3±9.8 mm Hg), and gestational hypertension (87.9±9.1 mm Hg) as compared with no hypertensive disorder of pregnancy (83.9±8.6 mm Hg). Change in blood pressure from preconception into very early pregnancy was associated with development of preeclampsia (relative risk, 1.13 [95% CI, 1.02-1.25] per 2 mm Hg increase in mean arterial pressure at 4 weeks' gestation), particularly preterm preeclampsia (relative risk, 1.21 [95% CI, 1.01-1.45]). Randomization to aspirin did not alter blood pressure trajectory or risk of hypertension in pregnancy. Preconception blood pressure and longitudinal changes during early pregnancy are underexplored but crucial windows in the detection and prevention of hypertensive disorders of pregnancy. Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00467363.",2020,Randomization to aspirin did not alter blood pressure trajectory or risk of hypertension in pregnancy.,"['1228 healthy women with a history of pregnancy loss to preconception-initiated low-dose', ""586 women with a pregnancy >20 weeks' gestation, preconception blood pressure levels were higher for preterm preeclampsia (87.3±6.7 mm Hg mean arterial pressure), term preeclampsia (88.3±9.8 mm Hg), and gestational hypertension (87.9±9.1 mm Hg) as compared with no hypertensive disorder of pregnancy (83.9±8.6 mm Hg"", 'and followed participants for up to 6 menstrual cycles attempting pregnancy and throughout pregnancy if they became pregnant']","['Aspirin', 'aspirin', 'aspirin versus placebo']","['blood pressure trajectory or risk of hypertension in pregnancy', 'blood pressure', 'mean arterial pressure', 'Blood pressure', 'preterm preeclampsia', 'preterm preeclampsia, term preeclampsia, and gestational hypertension', 'Preeclampsia and gestational hypertension']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032967', 'cui_str': 'H/O: pregnancy'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0341934', 'cui_str': 'Transient hypertension of pregnancy'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0565599', 'cui_str': 'Maternal hypertension'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0341934', 'cui_str': 'Transient hypertension of pregnancy'}]",1228.0,0.253145,Randomization to aspirin did not alter blood pressure trajectory or risk of hypertension in pregnancy.,"[{'ForeName': 'Carrie J', 'Initials': 'CJ', 'LastName': 'Nobles', 'Affiliation': 'From the Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (C.J.N., P.M., S.L.M., K.K., V.C.A., M.C., L.S., N.J.P., E.F.S.).'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Mendola', 'Affiliation': 'From the Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (C.J.N., P.M., S.L.M., K.K., V.C.A., M.C., L.S., N.J.P., E.F.S.).'}, {'ForeName': 'Sunni L', 'Initials': 'SL', 'LastName': 'Mumford', 'Affiliation': 'From the Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (C.J.N., P.M., S.L.M., K.K., V.C.A., M.C., L.S., N.J.P., E.F.S.).'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'Obstetrics and Gynecology, School of Medicine, University of Utah (R.M.S.).'}, {'ForeName': 'Keewan', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'From the Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (C.J.N., P.M., S.L.M., K.K., V.C.A., M.C., L.S., N.J.P., E.F.S.).'}, {'ForeName': 'Victoria C', 'Initials': 'VC', 'LastName': 'Andriessen', 'Affiliation': 'From the Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (C.J.N., P.M., S.L.M., K.K., V.C.A., M.C., L.S., N.J.P., E.F.S.).'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Connell', 'Affiliation': 'From the Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (C.J.N., P.M., S.L.M., K.K., V.C.A., M.C., L.S., N.J.P., E.F.S.).'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Sjaarda', 'Affiliation': 'From the Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (C.J.N., P.M., S.L.M., K.K., V.C.A., M.C., L.S., N.J.P., E.F.S.).'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Perkins', 'Affiliation': 'From the Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (C.J.N., P.M., S.L.M., K.K., V.C.A., M.C., L.S., N.J.P., E.F.S.).'}, {'ForeName': 'Enrique F', 'Initials': 'EF', 'LastName': 'Schisterman', 'Affiliation': 'From the Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (C.J.N., P.M., S.L.M., K.K., V.C.A., M.C., L.S., N.J.P., E.F.S.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.14875']
1768,32755802,Distance to white matter trajectories is associated with treatment response to internal capsule deep brain stimulation in treatment-refractory depression.,"BACKGROUND


Deep brain stimulation (DBS) is an innovative treatment for treatment-refractory depression. DBS is usually targeted at specific anatomical landmarks, with patients responding to DBS in approximately 50% of cases. Attention has recently shifted to white matter tracts to explain DBS response, with initial open-label trials targeting white matter tracts yielding much higher response rates (>70%).
OBJECTIVE/HYPOTHESIS


Our aim was to associate distance to individual white matter tracts around the stimulation target in the ventral anterior limb of the internal capsule to treatment response.
METHODS


We performed diffusion magnetic resonance tractography of the superolateral branch of the medial forebrain bundle and the anterior thalamic radiation in fourteen patients that participated in our randomized clinical trial. We combined the tract reconstructions with the postoperative images to identify the DBS leads and estimated the distance between tracts and leads, which we subsequently associated with treatment response.
RESULTS


Stimulation closer to both tracts was significantly correlated to a larger symptom decrease (r = 0.61, p = 0.02), suggesting that stimulation more proximal to the tracts was beneficial. Biophysical modelling indicated that 37.5% of tracts were even outside the volume of activated tissue. There was no difference in lead placement with respect to anatomical landmarks, which could mean that differences in treatment response were driven by individual differences in white matter anatomy.
CONCLUSIONS


Our results suggest that deep brain stimulation of the ventral anterior limb of the internal capsule could benefit from targeting white matter bundles. We recommend acquiring diffusion magnetic resonance data for each individual patient.",2020,"RESULTS


Stimulation closer to both tracts was significantly correlated to a larger symptom decrease (r = 0.61, p = 0.02), suggesting that stimulation more proximal to the tracts was beneficial.",['fourteen patients that participated in our randomized clinical trial'],"['DBS', 'Deep brain stimulation (DBS', 'diffusion magnetic resonance tractography of the superolateral branch of the medial forebrain bundle and the anterior thalamic radiation']",['lead placement'],"[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0025055', 'cui_str': 'Structure of median forebrain bundle'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",,0.085274,"RESULTS


Stimulation closer to both tracts was significantly correlated to a larger symptom decrease (r = 0.61, p = 0.02), suggesting that stimulation more proximal to the tracts was beneficial.","[{'ForeName': 'Luka C', 'Initials': 'LC', 'LastName': 'Liebrand', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam UMC, University of Amsterdam, Department of Biomedical Engineering and Physics, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands. Electronic address: L.C.Liebrand@amsterdamumc.nl.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Natarajan', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Matthan W A', 'Initials': 'MWA', 'LastName': 'Caan', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Biomedical Engineering and Physics, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'P Richard', 'Initials': 'PR', 'LastName': 'Schuurman', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Neurosurgery, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Pepijn', 'Initials': 'P', 'LastName': 'van den Munckhof', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Neurosurgery, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'de Kwaasteniet', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Luigjes', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Isidoor O', 'Initials': 'IO', 'LastName': 'Bergfeld', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Damiaan', 'Initials': 'D', 'LastName': 'Denys', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands; Netherlands Institute for Neuroscience, Royal Academy of Arts and Sciences, Meibergdreef 47, Amsterdam, Netherlands.'}, {'ForeName': 'Guido A', 'Initials': 'GA', 'LastName': 'van Wingen', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102363']
1769,32761191,"Efficacy of Ketogenic Diet, Modified Atkins Diet, and Low Glycemic Index Therapy Diet Among Children With Drug-Resistant Epilepsy: A Randomized Clinical Trial.","Importance


The ketogenic diet (KD) has been used successfully to treat children with drug-resistant epilepsy. Data assessing the efficacy of the modified Atkins diet (MAD) and low glycemic index therapy (LGIT) diet compared with the KD are scarce.
Objective


To determine whether the MAD and LGIT diet are noninferior to the KD among children with drug-resistant epilepsy.
Design, Setting, and Participants


One hundred seventy children aged between 1 and 15 years who had 4 or more seizures per month, had not responded to 2 or more antiseizure drugs, and had not been treated previously with the KD, MAD, or LGIT diet were enrolled between April 1, 2016, and August 20, 2017, at a tertiary care referral center in India.
Exposures


Children were randomly assigned to receive the KD, MAD, or LGIT diet as additions to ongoing therapy with antiseizure drugs.
Main Outcomes and Measures


Primary outcome was percentage change in seizure frequency after 24 weeks of dietary therapy in the MAD cohort compared with the KD cohort and in the LGIT diet cohort compared with the KD cohort. The trial was powered to assess noninferiority of the MAD and LGIT diet compared with the KD with a predefined, noninferiority margin of -15 percentage points. Intention-to-treat analysis was used.
Results


One hundred fifty-eight children completed the trial: KD (n = 52), MAD (n = 52), and LGIT diet (n = 54). Intention-to-treat analysis showed that, after 24 weeks of intervention, the median (interquartile range [IQR]) change in seizure frequency (KD: -66%; IQR, -85% to -38%; MAD: -45%; IQR, -91% to -7%; and LGIT diet: -54%; IQR, -92% to -19%) was similar among the 3 arms (P = .39). The median difference, per intention-to-treat analysis, in seizure reduction between the KD and MAD arms was -21 percentage points (95% CI, -29 to -3 percentage points) and between the KD and LGIT arms was -12 percentage points (95% CI, -21 to 7 percentage points), with both breaching the noninferiority margin of -15 percentage points. Treatment-related adverse events were similar between the KD (31 of 55 [56.4%]) and MAD (33 of 58 [56.9%]) arms but were significantly less in the LGIT diet arm (19 of 57 [33.3%]).
Conclusions and Relevance


Neither the MAD nor the LGIT diet met the noninferiority criteria. However, the results of this study for the LGIT diet showed a balance between seizure reduction and relatively fewer adverse events compared with the KD and MAD. These potential benefits suggest that the risk-benefit decision with regard to the 3 diet interventions needs to be individualized.
Trial Registration


ClinicalTrials.gov Identifier: NCT02708030.",2020,Treatment-related adverse events were similar between the KD (31 of 55 [56.4%]) and MAD (33 of 58 [56.9%]) arms,"['children with drug-resistant epilepsy', 'Participants\n\n\nOne hundred seventy children aged between 1 and 15 years who had 4 or more seizures per month, had not responded to 2 or more antiseizure drugs, and had not been treated previously with the KD, MAD, or LGIT diet were enrolled between April 1, 2016, and August 20, 2017, at a tertiary care referral center in India', 'One hundred fifty-eight children completed the trial: KD (n\u2009=\u200952), MAD (n\u2009=\u200952), and', 'Exposures\n\n\nChildren', 'Children With Drug-Resistant Epilepsy']","['LGIT diet', 'Ketogenic Diet, Modified Atkins Diet, and Low Glycemic Index Therapy Diet', 'MAD and LGIT diet', 'modified Atkins diet (MAD) and low glycemic index therapy (LGIT) diet', 'ketogenic diet (KD', 'KD, MAD, or LGIT diet as additions to ongoing therapy with antiseizure drugs']","['seizure frequency', 'adverse events', 'MAD', 'median difference, per intention-to-treat analysis, in seizure reduction']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1096063', 'cui_str': 'Refractory epilepsy'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",170.0,0.11082,Treatment-related adverse events were similar between the KD (31 of 55 [56.4%]) and MAD (33 of 58 [56.9%]) arms,"[{'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Sondhi', 'Affiliation': 'Center of Excellence & Advanced Research on Childhood Neurodevelopmental Disorders, Child Neurology Division, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Anuja', 'Initials': 'A', 'LastName': 'Agarwala', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ravindra M', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Biswaroop', 'Initials': 'B', 'LastName': 'Chakrabarty', 'Affiliation': 'Center of Excellence & Advanced Research on Childhood Neurodevelopmental Disorders, Child Neurology Division, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Jauhari', 'Affiliation': 'Center of Excellence & Advanced Research on Childhood Neurodevelopmental Disorders, Child Neurology Division, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Lodha', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Gurudyal S', 'Initials': 'GS', 'LastName': 'Toteja', 'Affiliation': 'Scientist H & Head (Nutrition), Indian Council of Medical Research, New Delhi, India.'}, {'ForeName': 'Shobha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Center of Excellence & Advanced Research on Childhood Neurodevelopmental Disorders, Child Neurology Division, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vinod K', 'Initials': 'VK', 'LastName': 'Paul', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Kossoff', 'Affiliation': 'Department of Neurology, Johns Hopkins Hospital, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Sheffali', 'Initials': 'S', 'LastName': 'Gulati', 'Affiliation': 'Center of Excellence & Advanced Research on Childhood Neurodevelopmental Disorders, Child Neurology Division, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.2282']
1770,32761611,The effect of trimodal prehabilitation on the physical and psychological health of patients undergoing colorectal surgery: a randomised clinical trial.,"Prehabilitation aims to increase the endurance capacity of patients who are awaiting major surgery. However, there are no studies investigating the implementation of this demanding and expensive intervention in low-income countries. This study aimed to assess the impact of a 4-week trimodal prehabilitation program on the physical and psychological health of patients waiting for colorectal surgery compared with a control group managed according to enhanced recovery after surgery principles supplemented by nutritional care. This study was a single-centre, randomised controlled trial. The primary outcome measures for the physical aspects were 6-minute walking distance (6MWD) and incentive spirometry, whereas the psychological elements were measured using the 36-item short form survey questionnaire and the hospital anxiety and depression score. In total, data from 149 patients were analysed (77 in the prehabilitation group and 72 in the control group). At the time of surgery, patients in the prehabilitation group had improved 6MWD and incentive spirometry compared with the control group (median (IQR [range]) percentage improvement 131% (112-173 [68-376]) vs. 107% (99-120 [63-163]); p < 0.001 and 113% (100-125 [75-200]) vs. 100% (100-112 [86-167]); p < 0.001 respectively). Patients in the prehabilitation group also had reduced anxiety scores compared with the control group (mean (SD) anxiety score (4 (3) vs. 5 (3) respectively; p = 0.032). However, these effects did not translate into improvements in postoperative mortality and morbidity, or a reduction in duration of hospital stay. Trimodal (physical, emotional and nutritional) prehabilitation is able to improve functional status as well as some parameters of emotional and physical well-being of patients waiting for colorectal surgery.",2020,"However, these effects did not translate into improvements in postoperative mortality and morbidity, or a reduction in duration of hospital stay.","['patients undergoing colorectal surgery', 'patients who are awaiting major surgery', '149 patients were analysed (77 in the prehabilitation group and 72 in the control group', 'patients waiting for colorectal surgery']","['trimodal prehabilitation program', 'trimodal prehabilitation']","['physical aspects were 6-minute walking distance (6MWD) and incentive spirometry, whereas the psychological elements were measured using the 36-item short form survey questionnaire and the hospital anxiety and depression score', 'reduced anxiety scores', 'postoperative mortality and morbidity', 'endurance capacity', 'anxiety score', '6MWD and incentive spirometry', 'duration of hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0542399', 'cui_str': 'Patient waiting for'}]","[{'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444858', 'cui_str': 'AM 6'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0454512', 'cui_str': 'Incentive spirometry'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",149.0,0.100995,"However, these effects did not translate into improvements in postoperative mortality and morbidity, or a reduction in duration of hospital stay.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fulop', 'Affiliation': '1st Department of Surgery, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Lakatos', 'Affiliation': 'Department of Surgery, St. Borbala Hospital, Tatabanya, Hungary.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Susztak', 'Affiliation': 'Department of Surgery, St. Borbala Hospital, Tatabanya, Hungary.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Szijarto', 'Affiliation': '1st Department of Surgery, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Banky', 'Affiliation': 'Department of Surgery, St. Borbala Hospital, Tatabanya, Hungary.'}]",Anaesthesia,['10.1111/anae.15215']
1771,32757835,OPT-In For Life: A Mobile Technology-Based Intervention to Improve HIV Care Continuum for Young Adults Living With HIV.,"Young adults living with HIV (YALH) have lower rates of retention in care and HIV viral suppression. Multiple barriers exist to engage YALH in care. We developed and implemented a multifaceted, mobile application-based intervention, ""OPT-In for Life,"" by targeting YALH to encourage retention in care and eventually viral suppression. The app integrated multiple user-friendly features for YALH to manage their HIV care, including a two-way secure messaging function, HIV-related laboratory results, and appointment or medication reminders. We recruited 92 YALH who were 18 to 34 years old and were newly diagnosed with HIV, had a history of falling out of care, or had a detectable HIV viral load into this intervention. Study participants used the app to manage their HIV care and to communicate and interact with their HIV care team. During the intervention period, the retention rate among our study participants increased from 41.3% at baseline to 78.6% at 6-month follow-up, maintained at 12-month follow-up (79.8%), and slightly decreased to 73.4% at 18-month follow-up but it was still significantly higher than the baseline retention rate ( p  < .0001). The viral suppression rate (HIV RNA <200 copies/ml) increased from 64.1% at baseline to about 85% at 6-month and at 12-month follow-up and reached 91.4% at 18-month ( p  = .0002) among participants who were retained in care. Our study demonstrated using a HIPAA-compliant mobile application as an effective intervention to engage YALH in care. This mobile technology-based intervention can be incorporated into routine clinical practice to improve HIV care continuum.",2020,The viral suppression rate (HIV RNA <200 copies/ml) increased from 64.1% at baseline to about 85% at 6-month and at 12-month follow-up and reached 91.4% at 18-month ( p  = .0002) among participants who were retained in care.,"['Young adults living with HIV (YALH', 'We recruited 92 YALH who were 18 to 34 years old and were newly diagnosed with HIV, had a history of falling out of care, or had a detectable HIV viral load into this intervention', 'Young Adults Living With HIV', 'Study participants used the app to manage their HIV care and to communicate and interact with their HIV care team']",['Mobile Technology-Based Intervention'],"['retention rate', 'viral suppression rate']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1561668', 'cui_str': 'History of fall'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",,0.0297418,The viral suppression rate (HIV RNA <200 copies/ml) increased from 64.1% at baseline to about 85% at 6-month and at 12-month follow-up and reached 91.4% at 18-month ( p  = .0002) among participants who were retained in care.,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zurlo', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Du', 'Affiliation': 'Pennsylvania State University, Hershey, PA, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Haynos', 'Affiliation': 'Pennsylvania State University, Hershey, PA, USA.'}, {'ForeName': 'Verbenia', 'Initials': 'V', 'LastName': 'Collins', 'Affiliation': 'Pennsylvania State University, Hershey, PA, USA.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Eshak', 'Affiliation': 'Pennsylvania State University, Hershey, PA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Whitener', 'Affiliation': 'Pennsylvania State University, Hershey, PA, USA.'}]",Health promotion practice,['10.1177/1524839920936247']
1772,32758296,Effects of remaining dentin thickness on the bond strength of bleached dentin.,"BACKGROUND


The bond strength of resin composites to dentin was reported to be related to either the remaining dentin thickness (RDT) or bleaching treatment. However, information is limited regarding the effects of RDT on the bond strength of bleached dentin. The present study aimed to investigate the effects of RDT on the microshear bond strength (μSBS) of resin cement to bleached dentin.
METHODS


A total of 120 dentin specimens were prepared and randomly divided into 2 groups: a bleaching group (group B) and a control group (group C). Hydrogen peroxide with a concentration of 35% (Ultradent, USA) was applied on the dentin surface for 2 × 1 d for group B, while no bleaching treatment was performed for group C. After the treatment, the specimens were finished and polished to obtain different RDTs (2, 1, and 0.5 mm) and divided into 3 groups of 20 specimens each. The bonding procedure was performed using Panavia V5 (Kuraray, Japan) with a bonding area of 0.785 mm 2 . For each group, half of the specimens were subjected to 5000 thermal cycles (subgroup T), while the other half did not receive thermocycling (subgroup N) (n = 10). The specimens were then subjected to the μSBS test using a universal testing machine. Data were analyzed by a three-way analysis of variance (α = 0.05). The fracture modes of the specimens were confirmed with a measuring microscope. Representative specimens with different fracture modes were observed with scanning electron microscopy (SEM).
RESULTS


The μSBS values were significantly affected by bleaching treatment (p < 0.001), whereas no significant effect was observed for thermocycling (p = 0.293). In terms of RDT, a significantly different μSBS value was found among the subgroups with different RDTs in group C (p = 0.003). However, the RDT did not significantly affect the μSBS values of bleached dentin in group B (p = 0.779). The μSBS values were significantly lower in group B than in group C (p < 0.001). A higher percentage of adhesive failure was observed in group B than in group C.
CONCLUSION


Based on the present findings, it can be concluded that the RDT did not affect the bond strength of resin cement to bleached dentin.
CLINICAL SIGNIFICANCE


Since RDT did not affect the bond strength of resin cement to bleached dentin, bonding procedures should not be performed immediately after intracoronal bleaching, even if the dentin is planned to be removed due to a tooth preparation process.",2020,The μSBS values were significantly lower in group B than in group C (p < 0.001).,['A total of 120 dentin specimens'],"['bleaching group', 'RDT', 'Hydrogen peroxide with a concentration of 35% (Ultradent, USA', 'scanning electron microscopy (SEM']","['bond strength of bleached dentin', 'microshear bond strength (μSBS', 'adhesive failure', 'μSBS values', 'μSBS value']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1292488', 'cui_str': 'Dentin specimen'}]","[{'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0026019', 'cui_str': 'Electron microscopic study'}]","[{'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0136598,The μSBS values were significantly lower in group B than in group C (p < 0.001).,"[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Prosthodontics, School and Hospital of Stomatology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Xiu-Jiao', 'Initials': 'XJ', 'LastName': 'Lin', 'Affiliation': 'Department of Prosthodontics, School and Hospital of Stomatology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ying-Hui', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Department of Prosthodontics, School and Hospital of Stomatology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Prosthodontics, School and Hospital of Stomatology, Fujian Medical University, Fuzhou, China. haoyu-cn@hotmail.com.'}]",BMC oral health,['10.1186/s12903-020-01206-3']
1773,32758299,EFFECT: a randomized phase II study of efficacy and impact on function of two doses of nab-paclitaxel as first-line treatment in older women with advanced breast cancer.,"BACKGROUND


Limited data are available regarding the use of nab-paclitaxel in older patients with breast cancer. A weekly schedule is recommended, but there is a paucity of evidence regarding the optimal dose. We evaluated the efficacy of two different doses of weekly nab-paclitaxel, with a specific focus on their corresponding impact on patient function, in order to address the lack of data specifically relating to the older population.
METHODS


EFFECT is an open-label, phase II trial wherein 160 women with advanced breast cancer aged ≥ 65 years were enrolled from 15 institutions within Italy. Patients were randomly assigned 1:1 to receive nab-paclitaxel 100 mg/m 2  (arm A) or 125 mg/m 2  (arm B) on days 1, 8, and 15 on a 28-day cycle, as first-line treatment for advanced disease. The primary endpoint was event-free survival (EFS), wherein an event was defined as disease progression (PD), functional decline (FD), or death. In each arm, the null hypothesis that the median EFS would be ≤ 7 months was tested against a one-sided alternative according to the Brookmeyer Crowley test. Secondary endpoints included objective response rate (ORR), clinical benefit rate (CBR), progression-free survival (PFS), overall survival (OS), and safety.
RESULTS


After a median follow-up of 32.6 months, 140 events were observed in 158 evaluable patients. Median EFS was 8.2 months (90% CI, 5.9-8.9; p = 0.188) in arm A vs 8.3 months (90% CI, 6.2-9.7, p = 0.078) in arm B. Progression-free survival, overall survival, and response rates were similar in both groups. A higher percentage of dose reductions and discontinuations due to adverse events (AEs) was noted in arm B. The most frequently reported non-haematological AEs were fatigue (grade [G] 2-3 toxicity occurrence in arm A vs B, 43% and 51%, respectively) and peripheral neuropathy (G2-3 arm A vs B, 19% and 38%, respectively).
CONCLUSION


Pre-specified outcomes were similar in both treatment arms. However, 100 mg/m 2  was significantly better tolerated with fewer neurotoxicity-related events, representing a more feasible dose to be recommended for older patients with advanced disease.
TRIAL REGISTRATION


EudraCT, 2012-002707-18 . Registered on June 4, 2012. NIH ClinicalTrials.gov, NCT02783222 . Retrospectively registered on May 26, 2016.",2020,A higher percentage of dose reductions and discontinuations due to adverse events (AEs) was noted in arm B.,"['older patients with breast cancer', 'older women with advanced breast cancer', '158 evaluable patients', '65\u2009years were enrolled from 15 institutions within Italy', 'older patients with advanced disease', '160 women with advanced breast cancer aged ≥']","['EFFECT', 'weekly nab-paclitaxel', 'nab-paclitaxel 100\u2009mg/m 2  (arm A) or 125', 'nab-paclitaxel']","['peripheral neuropathy', 'Median EFS', 'arm B. Progression-free survival, overall survival, and response rates', 'objective response rate (ORR), clinical benefit rate (CBR), progression-free survival (PFS), overall survival (OS), and safety', 'event-free survival (EFS), wherein an event was defined as disease progression (PD), functional decline (FD), or death', 'toxicity occurrence']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4319551', 'cui_str': '125'}]","[{'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",160.0,0.185607,A higher percentage of dose reductions and discontinuations due to adverse events (AEs) was noted in arm B.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Biganzoli', 'Affiliation': '""Sandro Pitigliani"" Department of Medical Oncology, Hospital of Prato, ASL Toscana Centro, Prato, Italy. laura.biganzoli@uslcentro.toscana.it.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Cinieri', 'Affiliation': 'Department of Medical Oncology, Perrino Hospital, ASL Brindisi, Brindisi, Italy.'}, {'ForeName': 'Rossana', 'Initials': 'R', 'LastName': 'Berardi', 'Affiliation': 'Department of Medical Oncology, Ospedali Riuniti di Ancona, Università Politecnica delle Marche, Ancona, Italy.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Pedersini', 'Affiliation': 'Breast Oncology Unit, Hospital Civili di Brescia, Brescia, Italy.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'McCartney', 'Affiliation': '""Sandro Pitigliani"" Department of Medical Oncology, Hospital of Prato, ASL Toscana Centro, Prato, Italy.'}, {'ForeName': 'Alessandro Marco', 'Initials': 'AM', 'LastName': 'Minisini', 'Affiliation': 'Department of Oncology, Azienda Ospedaliero Universitaria Integrata di Udine, Udine, Italy.'}, {'ForeName': 'Elena Rota', 'Initials': 'ER', 'LastName': 'Caremoli', 'Affiliation': 'Cancer Centre, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Spazzapan', 'Affiliation': 'Unit of Medical Oncology and Cancer Prevention, IRCCS CRO di Aviano, National Cancer Institute, Aviano, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Magnolfi', 'Affiliation': 'Department of Medical Oncology, Hospital Civile SS Trinità di Sora, Frosinone, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Brunello', 'Affiliation': 'Department of Medical Oncology, Veneto Institute of Oncology IOV Padova, Padua, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Risi', 'Affiliation': '""Sandro Pitigliani"" Department of Medical Oncology, Hospital of Prato, ASL Toscana Centro, Prato, Italy.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Palumbo', 'Affiliation': 'Department of Medical Oncology, IRCCS ICS Maugeri, Pavia, Italy.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Leo', 'Affiliation': 'Department of Medical Oncology, Vito Fazzi Hospital, Lecce, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'Division of Medical Senology, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Donati', 'Affiliation': 'Department of Oncology, Versilia Hospital (Camaiore-Lu), Viareggio, Italy.'}, {'ForeName': 'Sabino', 'Initials': 'S', 'LastName': 'De Placido', 'Affiliation': 'Department of Endocrinology and Molecular and Clinical Oncology, AOU Federico II, Naples, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Orlando', 'Affiliation': 'Department of Medical Oncology, Perrino Hospital, ASL Brindisi, Brindisi, Italy.'}, {'ForeName': 'Mirco', 'Initials': 'M', 'LastName': 'Pistelli', 'Affiliation': 'Department of Medical Oncology, Ospedali Riuniti di Ancona, Università Politecnica delle Marche, Ancona, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Parolin', 'Affiliation': 'Department of Medical Oncology, Azienda Ospedaliera Universitaria Integrata, Verona, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Mislang', 'Affiliation': '""Sandro Pitigliani"" Department of Medical Oncology, Hospital of Prato, ASL Toscana Centro, Prato, Italy.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Becheri', 'Affiliation': 'Geriatric Medicine Unit, AUSL Toscana Centro, Prato, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Puglisi', 'Affiliation': 'Department of Oncology, Azienda Ospedaliero Universitaria Integrata di Udine, Udine, Italy.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Sanna', 'Affiliation': '""Sandro Pitigliani"" Department of Medical Oncology, Hospital of Prato, ASL Toscana Centro, Prato, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Zafarana', 'Affiliation': '""Sandro Pitigliani"" Department of Medical Oncology, Hospital of Prato, ASL Toscana Centro, Prato, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Boni', 'Affiliation': 'Clinical Trials Centre, AOU University Hospital Careggi, Florence, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Mottino', 'Affiliation': 'Geriatric Medicine Unit, AUSL Toscana Centro, Prato, Italy.'}]",Breast cancer research : BCR,['10.1186/s13058-020-01319-1']
1774,32758689,"SARS-CoV-2 Clearance in COVID-19 Patients with Novaferon Treatment: A Randomized, Open-label, Parallel Group Trial.","BACKGROUND


The anti-viral effects of Novaferon, a potent antiviral protein drug on COVID-19 was evaluated in laboratory, and in a randomized, open-label, parallel group trial.
METHODS


In laboratory, the inhibition of Novaferon on viral replication in cells infected with SARS-CoV-2, and on prevention of SARS-CoV-2 entry into healthy cells was determined. Antiviral effects of Novaferon in COVID-19 patients with treatment of Novaferon, Novaferon plus Lopinavir/Ritonavir, or Lopinavir/Ritonavir were evaluated. The primary endpoint was the SARS-CoV-2 clearance rates on day 6 of treatment, and the secondary endpoint was the time to SARS-CoV-2 clearance.
RESULTS


Novaferon inhibited the viral replication (EC 50  = 1.02 ng/ml), and prevented viral infection (EC 50  = 0.10 ng/ml). Results from the 89 enrolled COVID-19 patients showed that both Novaferon and Novaferon plus Lopinavir/Ritonavir groups had significantly higher viral clearance rates on day 6than Lopinavir/Ritonavir group (50.0% vs.24.1%, p = 0.0400, and 60.0% vs.24.1%, p = 0.0053). Median time to viral clearance were 6 days, 6 days, and 9 days for three groups respectively, a 3-dayreductionin both Novaferon and Novaferon plus Lopinavir/Ritonavir groups compared with Lopinavir/Ritonavir group.
CONCLUSIONS


Novaferon exhibited anti-SARS-CoV-2 effects in vitro and in COVID-19 patients. These data justified the further evaluation of Novaferon.
TRIAL REGISTRATION NUMBER


number ChiCTR2000029496at the Chinese Clinical Trial Registry (http://www.chictr.org.cn/).",2020,"RESULTS


Novaferon inhibited the viral replication (EC 50  = 1.02 ng/ml), and prevented viral infection (EC 50  = 0.10 ng/ml).","['COVID-19 patients with treatment of Novaferon', 'COVID-19 Patients with Novaferon Treatment']","['Lopinavir/Ritonavir', 'Novaferon plus Lopinavir/Ritonavir, or Lopinavir/Ritonavir', 'Novaferon', '6than Lopinavir/Ritonavir']","['viral infection', 'SARS-CoV-2 Clearance', 'Median time to viral clearance', 'viral replication', 'SARS-CoV-2 clearance rates', 'time to SARS-CoV-2 clearance', 'viral clearance rates']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3273451', 'cui_str': 'Novaferon'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C3273451', 'cui_str': 'Novaferon'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0042774', 'cui_str': 'Virus Replication'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}]",89.0,0.111733,"RESULTS


Novaferon inhibited the viral replication (EC 50  = 1.02 ng/ml), and prevented viral infection (EC 50  = 0.10 ng/ml).","[{'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zheng', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Yanwen', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Medicine, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ye', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Baoying', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Yaxiong', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zuo', 'Affiliation': 'Department of Intensive Care Unit, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': 'Department of Pediatrics, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Internal Medicine, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Peihua', 'Initials': 'P', 'LastName': 'Niu', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Wenlong', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Peng', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhou', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Chunlin', 'Initials': 'C', 'LastName': 'Cai', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Xinqiang', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhiguang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Key Laboratory of Diabetes Immunology (Central South University), Ministry of Education, National Clinical Research Center for Metabolic Diseases, the Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yongfang', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China. Electronic address: jiangyongfang@csu.edu.cn.'}, {'ForeName': 'Yuanlin', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China. Electronic address: 1286779459@qq.com.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Tan', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China. Electronic address: tanwj@ivdc.chinacdc.cn.'}, {'ForeName': 'Guozhong', 'Initials': 'G', 'LastName': 'Gong', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China. Electronic address: gongguozhong@csu.edu.cn.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.07.053']
1775,32759439,Efficacy of pectoral nerve block type II versus thoracic paravertebral block for analgesia in breast cancer surgery.,"OBJECTIVE


The aim: to compare the efficacy of pectoral nerve block type II and thoracic paravertebral block for analgesia during and after breast cancer surgery.
PATIENTS AND METHODS


Materials and methods: Sixty adult women were undergoing unilateral radical mastectomy or quadrantectomy with axillary dissection. Patients were randomized to receive either pectoral nerve block with ropivacaine 0.375% 30 ml or thoracic paravertebral block with ropivacaine 0.5% 20 ml. Evaluated variables included pain intensity at 0, 2, 4, 6, 12, 18 and 24 hours, intraoperative fentanyl, 24-hour postoperative opioid (promedol) and nonopioid (ketoprofen) consumption, the time to first rescue analgesia.
RESULTS


Results: There were no statistically significant differences between pectoral block and paravertebral block groups in intraoperative fentanyl consumption 2,2 (1,81-2,81) vs 1,9 (1,63-2,25) mcg/kg/hour (Р>0,05) and in the pain intensity during the first 24 hours after operation. The mean postoperative 24-hour promedol and ketoprofen consumption was 4,0 (±8,14) mgvs 5,0 (±8,85) mg (Р>0,05) and 66,7 (±66,09) mgvs 95,8 (±90,78) mg (Р>0,05) in the pectoral and paravertebral block groups respectively. Time to the first analgesia request was longer in pectoral block group - 540 (455,0-600,0) min vs 515 (265,0-650,0) min (Р>0,05). There were no complications after pectoral blocks and 2 complications after paravertebral blocks.
CONCLUSION


Conclusions: in breast cancer surgery pectoral nerve blocktype II can provide postoperative analgesia comparable to thoracic paravertebral block with lower complications rate.",2020,"There were no statistically significant differences between pectoral block and paravertebral block groups in intraoperative fentanyl consumption 2,2 (1,81-2,81)","[' Sixty adult women were undergoing', 'breast cancer surgery']","['pectoral nerve block type II and thoracic paravertebral block', 'pectoral nerve block with ropivacaine 0.375% 30 ml or thoracic paravertebral block with ropivacaine', 'pectoral nerve block type II versus thoracic paravertebral block', 'unilateral radical mastectomy or quadrantectomy with axillary dissection']","['pain intensity', 'intraoperative fentanyl, 24-hour postoperative opioid (promedol) and nonopioid (ketoprofen) consumption, the time to first rescue analgesia', 'mean postoperative 24-hour promedol and ketoprofen consumption']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205967', 'cui_str': 'Pectoral Nerves'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C4517455', 'cui_str': '0.375'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0024884', 'cui_str': 'Radical mastectomy'}, {'cui': 'C0337354', 'cui_str': 'Quadrantectomy of breast'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0242937', 'cui_str': 'Non-opioid analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0033400', 'cui_str': 'Dimethylmeperidine'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}]",60.0,0.0664339,"There were no statistically significant differences between pectoral block and paravertebral block groups in intraoperative fentanyl consumption 2,2 (1,81-2,81)","[{'ForeName': 'Volodymyr V', 'Initials': 'VV', 'LastName': 'Martsiniv', 'Affiliation': 'Shupyk National Medical Academy Of Postgraduate Education, Kyiv, Ukraine, Feofaniya Clinical Hospital Of State Management Of Affairs, Kyiv, Ukraine.'}, {'ForeName': 'Oleg A', 'Initials': 'OA', 'LastName': 'Loskutov', 'Affiliation': 'Shupyk National Medical Academy Of Postgraduate Education, Kyiv, Ukraine.'}, {'ForeName': 'Andriy M', 'Initials': 'AM', 'LastName': 'Strokan', 'Affiliation': 'Shupyk National Medical Academy Of Postgraduate Education, Kyiv, Ukraine, Feofaniya Clinical Hospital Of State Management Of Affairs, Kyiv, Ukraine.'}, {'ForeName': 'Mihaylo V', 'Initials': 'MV', 'LastName': 'Bondar', 'Affiliation': 'Shupyk National Medical Academy Of Postgraduate Education, Kyiv, Ukraine.'}]","Wiadomosci lekarskie (Warsaw, Poland : 1960)",[]
1776,32767349,Corticosteroid therapy for patients with severe novel Coronavirus disease 2019.,"OBJECTIVE


To investigate the effect of corticosteroid on hospital mortality, hospital length of stay, and time of viral clearance in patients with severe and critical COVID-19.
PATIENTS AND METHODS


Patients with severe and critical COVID-19 who had been discharged or expired were enrolled in this study. Patients were divided into corticosteroid group and non-corticosteroid group according to the systemic corticosteroid use or not. Clinical data were collected, and hospital mortality, hospital length of stay, time of viral clearance, time of mechanical ventilation, and duration from illness onset to symptom resolution were compared between the two groups.
RESULTS


A total of 72 inpatients who were diagnosed with severe and critical COVID-19 were enrolled, in which 47 patients were divided into corticosteroid group and 25 were involved as the non-corticosteroid group. Baseline characteristics were generally similar between the two groups. Four (5.6%) patients died during hospitalization, and 68 (94.4%) were discharged. Among survivors, the mean duration time from admission to discharge was 19.5d (SD 7.05 d). The mean time of viral clearance among survivors was 17.5d (SD 7.67 d), with a maximum of 37 d, and a minimum of 5 d. Hospital mortality (4.3% vs. 8.0%), length of hospital stay (18.7d vs. 21.0d), and time of viral clearance (16.1d vs. 19.4d) had no significant difference between two groups (p>0.05). The duration of symptoms suffering was shorter in the corticosteroid group than non-corticosteroid group, with statistically significant difference (p<0.05).
CONCLUSIONS


Corticosteroid therapy in patients with severe COVID-19 cannot reduce the hospital mortality, and is not associated with delayed viral clearance, but it could relieve the inflammatory storm and improve clinical symptoms in brief. Patients with severe COVID-19 could benefit from low-dose corticosteroid treatment.",2020,"The duration of symptoms suffering was shorter in the corticosteroid group than non-corticosteroid group, with statistically significant difference (p<0.05).
","['Patients with severe and critical COVID-19 who had been discharged or expired were enrolled in this study', '72 inpatients who were diagnosed with severe and critical COVID-19 were enrolled, in which 47 patients were divided into corticosteroid group and 25 were involved as the non-corticosteroid group', 'patients with severe and critical COVID-19', 'patients with severe novel Coronavirus disease 2019']","['corticosteroid', 'Corticosteroid therapy', 'corticosteroid group and non-corticosteroid']","['Hospital mortality', 'duration of symptoms suffering', 'mean duration time from admission to discharge', 'hospital mortality, hospital length of stay, time of viral clearance, time of mechanical ventilation, and duration from illness onset to symptom resolution', 'hospital mortality, hospital length of stay, and time of viral clearance', 'mean time of viral clearance', 'length of hospital stay', 'hospital mortality', 'time of viral clearance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",72.0,0.0940617,"The duration of symptoms suffering was shorter in the corticosteroid group than non-corticosteroid group, with statistically significant difference (p<0.05).
","[{'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Ma', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, The Second Affiliated hospital of Chongqing Medical Universty, Chongqing, China. 300293@hospital.cqmu.edu.cn.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Qi', 'Affiliation': ''}, {'ForeName': 'X-Y', 'Initials': 'XY', 'LastName': 'Deng', 'Affiliation': ''}, {'ForeName': 'G-D', 'Initials': 'GD', 'LastName': 'Yuan', 'Affiliation': ''}, {'ForeName': 'W-G', 'Initials': 'WG', 'LastName': 'Tian', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': ''}, {'ForeName': 'X-F', 'Initials': 'XF', 'LastName': 'Yan', 'Affiliation': ''}, {'ForeName': 'D-X', 'Initials': 'DX', 'LastName': 'Wang', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202008_22508']
1777,32767879,[Comparative study of anterior cruciate ligament reconstruction between the One Band and U-Two techniques].,"INTRODUCTION


ACL injuries are found within the most common ligament injuries. This has led to the development of different surgical techniques to restore knee stability.
MATERIAL Y METHODS


Clinical study, randomized, blind comparing ACL reconstruction techniques with One Band and «U-Two» using clinical scales and arthrometria with KT-1000 and Pivot Shift Meter.
RESULTS


Of 36 patients, 52.94% was drawn for the One Band technique and 47.06% for «U-Two». 11.76% of patients had a displacement greater than 11mm in the affected knee with KT-1000. 8.82% showed an equal anterior displacement on both knees. One patient had a major previous displacement after reconstruction surgery with the one band technique, but with improvement on clinical scales. Pivot Shift measurements found a difference in displacement greater than 4,000 m/s on the X axis following the One Band technique compared to the healthy knee calculating integrals, while with U-Two the difference was less than 600 m/s. On the Y axis a difference of 3,500 m/s was found between the healthy and the injured leg, which decreases to less than 2,000 m/s after reconstruction using U-Two technique.
CONCLUSIONS


Differences have been found throughout the study in patient evolution, indicating that repair using the U-Dos technique has better results in recovering the anteroposterior and rotational stability of the affected limb.",2019,"On the Y axis a difference of 3,500 m/s was found between the healthy and the injured leg, which decreases to less than 2,000 m/s after reconstruction using U-Two technique.
",[],"['ACL reconstruction techniques with One Band and «', 'anterior cruciate ligament reconstruction']",['clinical scales'],[],"[{'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0168216,"On the Y axis a difference of 3,500 m/s was found between the healthy and the injured leg, which decreases to less than 2,000 m/s after reconstruction using U-Two technique.
","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Berumen-Nafarrate', 'Affiliation': 'Ortopedia y Traumatología, Hospital Christus Muguerza del Parque. Chihuahua, Chihuahua. México.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Carmona-González', 'Affiliation': 'Facultad de Medicina y Ciencias Biomédicas, Universidad Autónoma de Chihuahua. México.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Tonche-Ramos', 'Affiliation': 'Facultad de Medicina y Ciencias Biomédicas, Universidad Autónoma de Chihuahua. México.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Carmona-Máynez', 'Affiliation': 'Ortopedia y Traumatología, Hospital Christus Muguerza del Parque. Chihuahua, Chihuahua. México.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Aguirre-Madrid', 'Affiliation': 'Ortopedia y Traumatología, Hospital Christus Muguerza del Parque. Chihuahua, Chihuahua. México.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Moreno-Brito', 'Affiliation': 'Facultad de Medicina y Ciencias Biomédicas, Universidad Autónoma de Chihuahua. México.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Leal-Berumen', 'Affiliation': 'Facultad de Medicina y Ciencias Biomédicas, Universidad Autónoma de Chihuahua. México.'}]",Acta ortopedica mexicana,[]
1778,32767971,Intraoperative cell salvage for obstetrics: a prospective randomized controlled clinical trial.,"BACKGROUND


The latest basic studies and clinical evidence have confirmed the safety and efficacy of intraoperative autologous blood cell transfusion in cardiac surgery and orthopaedics. However, in caesarean section, there are still concerns about the contamination of amniotic fluid and foetal components, and consequently the application of intraoperative autologous blood cell transfusion is not universal. Therefore, this study aimed to evaluate the clinical value of intraoperative autologous blood cell transfusion in obstetric surgery.
METHODS


A prospective, randomized, controlled, feasibility study was performed in women undergoing caesarean section. One hundred sixteen participants were randomly assigned at a 1:1 ratio into either the intraoperative cell salvage group or the control group. Allogeneic blood cells were transfused into patients with haemoglobin concentrations < 80 g/dL in both the intraoperative cell salvage group and the control group.
RESULTS


No significant differences were found between the two groups in age, weight, maternal parity, history of previous caesarean section, gestational weeks of delivery, etc. However, compared with the control group, patients in the intraoperative cell salvage group had a significantly lower amount of allogeneic blood cell transfusion, lower incidence of postoperative incision infection, delayed wound healing, perioperative allergy, adverse cardiovascular events, hypoproteinaemia and shorter hospital stay.
CONCLUSION


The results of this study suggest that the use of autologous blood cell transfusion is safe and effective for patients with obstetric haemorrhage.
TRIAL REGISTRATION


All procedures performed in studies involving human participants were in accordance with the ethical standards of the Institutional and/or National Research Committee of Beijing Obstetrics and Gynecology Hospital, Capital Medical University (2016-XJS-003-01) as well as the 1964 Helsinki Declaration and its later amendments or other comparable ethical standards. The clinical trials were registered (ChiCTR-ICC-15,007,096) on September 28, 2015.",2020,"No significant differences were found between the two groups in age, weight, maternal parity, history of previous caesarean section, gestational weeks of delivery, etc.","['women undergoing caesarean section', 'patients with obstetric haemorrhage', 'obstetrics', 'One hundred sixteen participants']","['Intraoperative cell salvage', 'intraoperative cell salvage group or the control group', 'autologous blood cell transfusion', 'intraoperative autologous blood cell transfusion']","['Allogeneic blood cells', 'age, weight, maternal parity, history of previous caesarean section, gestational weeks of delivery, etc', 'allogeneic blood cell transfusion, lower incidence of postoperative incision infection, delayed wound healing, perioperative allergy, adverse cardiovascular events, hypoproteinaemia and shorter hospital stay']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005773', 'cui_str': 'Blood cell'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]","[{'cui': 'C0005773', 'cui_str': 'Blood cell'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0269733', 'cui_str': 'Previous caesarean section'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0151692', 'cui_str': 'Impaired wound healing'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0020639', 'cui_str': 'Hypoproteinemia'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",116.0,0.0395346,"No significant differences were found between the two groups in age, weight, maternal parity, history of previous caesarean section, gestational weeks of delivery, etc.","[{'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Anaesthesiology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, 100026, Beijing, China.'}, {'ForeName': 'Xiaoguang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Anaesthesiology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, 100026, Beijing, China.'}, {'ForeName': 'Xiangming', 'Initials': 'X', 'LastName': 'Che', 'Affiliation': 'Department of Anaesthesiology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, 100026, Beijing, China.'}, {'ForeName': 'Guosheng', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Department of Anaesthesiology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, 100026, Beijing, China.'}, {'ForeName': 'Mingjun', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Department of Anaesthesiology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, 100026, Beijing, China. snake650222@126.com.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03138-w']
1779,32767988,"A single-center, randomized, non-inferiority study evaluating seroma formation after mastectomy combined with flap fixation with or without suction drainage: protocol for the Seroma reduction and drAin fRee mAstectomy (SARA) trial.","BACKGROUND


Seroma formation is a common complication after breast cancer surgery and can lead to delayed wound healing, infection, patient discomfort and repeated visits to the outpatient clinic. Mastectomy combined with flap fixation is becoming standard practice and is currently combined with closed-suction drainage. There is evidence showing that closed-suction drainage may be insufficient in preventing seroma formation. There is reasonable doubt whether there is still place for closed-suction drainage after mastectomy when flap fixation is performed. We hypothesize that mastectomy combined with flap fixation and closed suction drainage does not cause a significant lower incidence of seroma aspirations, when compared to mastectomy and flap fixation alone. Furthermore, we expect that patients without drainage will experience significantly less discomfort and comparable rates of surgical site infections.
METHODS


This is a randomized controlled trial in female breast cancer patients undergoing mastectomy and flap fixation using sutures with or without sentinel lymph node biopsy (SLNB). Patients will be eligible for inclusion if they are older than 18 years, have an indication for mastectomy with or without sentinel procedure. Exclusion criteria are modified radical mastectomy, direct breast reconstruction, previous history of radiation therapy of the unilateral breast, breast conserving therapy and inability to give informed consent. A total of 250 patients will be randomly allocated to one of two groups: mastectomy combined with flap fixation and closed-suction drainage or mastectomy combined with flap fixation without drainage. Follow-up will be conducted up to six months postoperatively. The primary outcome is the proportion of patients undergoing one or more seroma aspirations. Secondary outcome measures consist of the number of invasive interventions, surgical site infection, quality of life measured using the SF-12 Health Survey, cosmesis, pain and number of additional outpatient department visits.
DISCUSSION


To our knowledge, no randomized controlled trial has been conducted comparing flap fixation with and without closed-suction drainage with seroma aspiration as the primary outcome. This study could result in finding evidence that supports performing mastectomy without closed-suction drainage.
TRIAL REGISTRATION


This trial was approved by the medical ethical committee of Zuyderland Medical Center METC-Z on 20 March 2019 (METCZ20190023). The SARA Trial was registered at ClinicalTrials.gov as per July 2019, Identifier: NCT04035590 .",2020,"We hypothesize that mastectomy combined with flap fixation and closed suction drainage does not cause a significant lower incidence of seroma aspirations, when compared to mastectomy and flap fixation alone.","['Patients will be eligible for inclusion if they are older than 18\u2009years, have an indication for mastectomy with or without sentinel procedure', '250 patients', 'female breast cancer patients undergoing']","['Mastectomy combined with flap fixation', 'mastectomy combined with flap fixation with or without suction drainage: protocol', 'flap fixation with and without closed-suction drainage with seroma aspiration', 'mastectomy combined with flap fixation and closed suction drainage', 'mastectomy combined with flap fixation and closed-suction drainage or mastectomy combined with flap fixation without drainage', 'mastectomy and flap fixation using sutures with or without sentinel lymph node biopsy (SLNB']","['seroma formation', 'number of invasive interventions, surgical site infection, quality of life measured using the SF-12 Health Survey, cosmesis, pain and number of additional outpatient department visits', 'proportion of patients undergoing one or more seroma aspirations', 'discomfort']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast'}]","[{'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}]","[{'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",250.0,0.150699,"We hypothesize that mastectomy combined with flap fixation and closed suction drainage does not cause a significant lower incidence of seroma aspirations, when compared to mastectomy and flap fixation alone.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'de Rooij', 'Affiliation': 'Department of Surgery, Zuyderland Medical Center, Postbus 5500, 6130, MB, Sittard, the Netherlands. l.derooij@zuyderland.nl.'}, {'ForeName': 'Sander M J', 'Initials': 'SMJ', 'LastName': 'van Kuijk', 'Affiliation': 'Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Els R M', 'Initials': 'ERM', 'LastName': 'van Haaren', 'Affiliation': 'Department of Surgery, Zuyderland Medical Center, Postbus 5500, 6130, MB, Sittard, the Netherlands.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Janssen', 'Affiliation': 'Department of Surgery, Zuyderland Medical Center, Postbus 5500, 6130, MB, Sittard, the Netherlands.'}, {'ForeName': 'Yvonne L J', 'Initials': 'YLJ', 'LastName': 'Vissers', 'Affiliation': 'Department of Surgery, Zuyderland Medical Center, Postbus 5500, 6130, MB, Sittard, the Netherlands.'}, {'ForeName': 'Geerard L', 'Initials': 'GL', 'LastName': 'Beets', 'Affiliation': 'Department of Surgery, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'van Bastelaar', 'Affiliation': 'Department of Surgery, Zuyderland Medical Center, Postbus 5500, 6130, MB, Sittard, the Netherlands.'}]",BMC cancer,['10.1186/s12885-020-07242-0']
1780,32767989,Technology versus tradition: a non-inferiority trial comparing video to face-to-face consultations with a physiotherapist for people with knee osteoarthritis. Protocol for the PEAK randomised controlled trial.,"BACKGROUND


Knee osteoarthritis (OA) is a global problem that causes significant pain and physical dysfunction, substantially impacting on quality of life and imposing enormous cost to the healthcare system. Exercise is pivotal to OA management, yet uptake by people with knee OA is inadequate. Limited access to appropriately skilled health professionals, such as physiotherapists, for prescription of an exercise program and support with exercise is a major barrier to optimal care. Internet-enabled video consultations permit widespread reach. However, services offering video consultations with physiotherapists for musculoskeletal conditions are scant in Australia where there is typically no Government or private health insurer funding for such services. The paucity of robust evidence demonstrating video consultations with physiotherapists are clinically effective, safe and cost-effective for knee OA is hampering implementation of, and willingness of healthcare policymakers to pay for, these services.
METHODS


This is an assessor- and participant-blinded, two-arm, pragmatic, comparative effectiveness non-inferiority randomised controlled trial (RCT) conducted in Australia. We are recruiting 394 people from the community with chronic knee pain consistent with a clinical diagnosis of knee OA. Participants are randomly allocated to receive physiotherapy care via i) video-conferencing or; ii) face-to-face consultations. Participants are provided five consultations (30-45 min each) with a physiotherapist over 3 months for prescription of a home-based strengthening exercise program (to be conducted independently at home) and physical activity plan, as well as OA education. Participants in both groups are provided with educational booklets and simple exercise equipment via post. The co-primary outcomes are change in self-reported i) knee pain on walking; and ii) physical function, with a primary end-point of 3 months and a secondary end-point of 9 months. Secondary outcomes include changes in other clinical outcomes (health-related quality of life; therapeutic relationship; global ratings of change; satisfaction with care; self-efficacy; physical activity levels), time and financial costs of attending consultations, healthcare usage and convenience. Non-inferiority will be assessed using the per-protocol dataset.
DISCUSSION


Findings will determine if video consultations with physiotherapists are non-inferior to traditional face-to-face consultations for management of people with knee OA.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry, ACTRN12619001240134. http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377672&isReview=true.",2020,"DISCUSSION


Findings will determine if video consultations with physiotherapists are non-inferior to traditional face-to-face consultations for management of people with knee OA.
","['394 people from the community with chronic knee pain consistent with a clinical diagnosis of knee OA', 'Knee osteoarthritis (OA', 'people with knee osteoarthritis']","['http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377672&isReview=true', 'Technology versus tradition', 'educational booklets and simple exercise equipment via post', 'physiotherapy care via i) video-conferencing or; ii) face-to-face consultations', 'physiotherapist over 3\u2009months for prescription of a home-based strengthening exercise program (to be conducted independently at home) and physical activity plan, as well as OA education']","['change in self-reported i) knee pain on walking; and ii) physical function, with a primary end-point of 3\u2009months and a secondary end-point of 9\u2009months', 'changes in other clinical outcomes (health-related quality of life; therapeutic relationship; global ratings of change; satisfaction with care; self-efficacy; physical activity levels), time and financial costs of attending consultations, healthcare usage and convenience']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}]",394.0,0.114132,"DISCUSSION


Findings will determine if video consultations with physiotherapists are non-inferior to traditional face-to-face consultations for management of people with knee OA.
","[{'ForeName': 'Rana S', 'Initials': 'RS', 'LastName': 'Hinman', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Faculty of Medicine Dentistry & Health Sciences, The University of Melbourne, Melbourne, Australia. ranash@unimelb.edu.au.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Kimp', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Faculty of Medicine Dentistry & Health Sciences, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Penny K', 'Initials': 'PK', 'LastName': 'Campbell', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Faculty of Medicine Dentistry & Health Sciences, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Russell', 'Affiliation': 'RECOVER Injury Research Centre, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Nadine E', 'Initials': 'NE', 'LastName': 'Foster', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kasza', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Harris', 'Affiliation': 'Centre for Health Economics, Monash Business School, Monash University, Melbourne, Australia.'}, {'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Faculty of Medicine Dentistry & Health Sciences, The University of Melbourne, Melbourne, Australia.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03523-8']
1781,32768050,Spatially localized sparse representations for breast lesion characterization.,"RATIONALE


The topic of sparse representation of samples in high dimensional spaces has attracted growing interest during the past decade. In this work, we develop sparse representation-based methods for classification of radiological imaging patterns of breast lesions into benign and malignant states.
METHODS


We propose a spatial block decomposition method to address irregularities of the approximation problem and to build an ensemble of classifiers (CL) that we expect to yield more accurate numerical solutions than conventional whole-region of interest (ROI) sparse analyses. We introduce two classification decision strategies based on maximum a posteriori probability (BBMAP-S), or a log likelihood function (BBLL-S).
RESULTS


To evaluate the performance of the proposed approach we used cross-validation techniques on imaging datasets with disease class labels. We utilized the proposed approach for separation of breast lesions into benign and malignant categories in mammograms. The level of difficulty is high in this application and the accuracy may depend on the lesion size. Our results indicate that the proposed integrative sparse analysis addresses the ill-posedness of the approximation problem, producing AUC (area under the receiver operating curve) value of 89.1% for randomized 30-fold cross-validation.
CONCLUSIONS


Furthermore, our comparative experiments showed that the BBLL-S decision function may yield more accurate classification than BBMAP-S because BBLL-S accounts for possible estimation bias.",2020,"We introduce two classification decision strategies based on maximum a posteriori probability (BBMAP-S), or a log likelihood function (BBLL-S).
",[],[],[],[],[],[],,0.0375101,"We introduce two classification decision strategies based on maximum a posteriori probability (BBMAP-S), or a log likelihood function (BBLL-S).
","[{'ForeName': 'Keni', 'Initials': 'K', 'LastName': 'Zheng', 'Affiliation': 'Division of Physics, Engineering, Mathematics and Computer Science, Delaware State University, 1200 N. DuPont Hwy, Dover, DE, 19901-2277, USA.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Harris', 'Affiliation': 'Division of Physics, Engineering, Mathematics and Computer Science, Delaware State University, 1200 N. DuPont Hwy, Dover, DE, 19901-2277, USA.'}, {'ForeName': 'Predrag', 'Initials': 'P', 'LastName': 'Bakic', 'Affiliation': 'Department of Radiology, Univ. of Pennsylvania, Philadelphia, PA, 19152, USA.'}, {'ForeName': 'Sokratis', 'Initials': 'S', 'LastName': 'Makrogiannis', 'Affiliation': 'Division of Physics, Engineering, Mathematics and Computer Science, Delaware State University, 1200 N. DuPont Hwy, Dover, DE, 19901-2277, USA. Electronic address: smakrogiannis@desu.edu.'}]",Computers in biology and medicine,['10.1016/j.compbiomed.2020.103914']
1782,32769608,"Shockwave: Does It Work Like Magic for Greater Trochanteric Pain Syndrome?: Commentary on an article by Silvia Ramon MD, PhD, et al.: ""Focused Shockwave Treatment for Greater Trochanteric Pain Syndrome. A Multicenter, Randomized, Controlled Clinical Trial"".",,2020,,['Greater Trochanteric Pain Syndrome'],"['Focused Shockwave Treatment', 'Shockwave']",[],"[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0391976', 'cui_str': 'Pain Disorder'}]","[{'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0335625,,"[{'ForeName': 'Mengnai', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedic Surgery, Ohio State University Wexner Medical Center, Columbus, Ohio.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.01067']
1783,32769625,"Online Cognitive Training: An Adaptation of the Memory, Attention, and Problem Solving Skills for Persons With Diabetes Intervention.","Research shows the risk for cognitive impairment and the rate of cognitive decline double after type 2 diabetes mellitus is diagnosed and can make self-management more difficult. Cognitive training has been found to be one way to improve self-management and cognitive function, and this article reports the adaptation of one such intervention to an online format. Ten adults with diabetes participated in an 8-week intervention that combined webinar classes with online computer game training. Perceived memory ability, executive function, self-management, and self-efficacy were measured. Evaluation of recruitment, data collection, and implementation demonstrated good feasibility and reduced barriers to engagement. Although the intervention did not result in significant changes in cognitive function, scores on all surveys improved. Adherence to diet, exercise, and foot care recommendations also improved. Most participants stated they preferred the intervention's online format to ""traditional"" in-person formats. Online technology in this 8-week intervention helped improve recruitment, retention, participant engagement, and use of cognitive strategies in people with type 2 diabetes mellitus. Overall, participants found the intervention helpful and said it reduced the time and travel burden associated with educational interventions. A larger randomized controlled trial is needed to further explore the intervention's potential impact over a longer period.",2020,"Online technology in this 8-week intervention helped improve recruitment, retention, participant engagement, and use of cognitive strategies in people with type 2 diabetes mellitus.","['Persons With Diabetes Intervention', 'Ten adults with diabetes participated in an', 'people with type 2 diabetes mellitus']","['8-week intervention that combined webinar classes with online computer game training', 'Online Cognitive Training', 'Cognitive training']","['time and travel burden', 'Perceived memory ability, executive function, self-management, and self-efficacy', 'cognitive function, scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0029038', 'cui_str': 'On-Line Systems'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0040802', 'cui_str': 'Travel'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",10.0,0.0343471,"Online technology in this 8-week intervention helped improve recruitment, retention, participant engagement, and use of cognitive strategies in people with type 2 diabetes mellitus.","[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Cuevas', 'Affiliation': 'Author Affiliations: School of Nursing, The University of Texas at Austin, Texas.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Carter', 'Affiliation': ''}]","Computers, informatics, nursing : CIN",['10.1097/CIN.0000000000000663']
1784,32758233,A cluster randomized trial of delivery of intermittent preventive treatment of malaria in pregnancy at the community level in Burkina Faso.,"BACKGROUND


Malaria in pregnancy is responsible for 8-14% of low birth weight and 20% of stillbirths in sub-Saharan Africa. To prevent these adverse consequences, the World Health Organization recommends intermittent preventive treatment of pregnant women (IPTp) with sulfadoxine-pyrimethamine be administered at each ANC visit starting as early as possible in the second trimester. Global IPTp coverage in targeted countries remains unacceptably low. Community delivery of IPTp was explored as a means to improve coverage.
METHODS


A cluster randomized, controlled trial was conducted in 12 health facilities in a 1:1 ratio to either an intervention group (IPTp delivered by CHWs) or a control group (standard practice, with IPTp delivered at HFs) in three districts of Burkina Faso to assess the effect of IPTp administration by community health workers (CHWs) on the coverage of IPTp and antenatal care (ANC). The districts and facilities were purposively selected taking into account malaria epidemiology, IPTp coverage, and the presence of active CHWs. Pre- and post-intervention surveys were carried out in March 2017 and July-August 2018, respectively. A difference in differences (DiD) analysis was conducted to assess the change in coverage of IPTp and ANC over time, accounting for clustering at the health facility level.
RESULTS


Altogether 374 and 360 women were included in the baseline and endline surveys, respectively. At baseline, women received a median of 2.1 doses; by endline, women received a median of 1.8 doses in the control group and 2.8 doses in the intervention group (p-value < 0.0001). There was a non-statistically significant increase in the proportion of women attending four ANC visits in the intervention compared to control group (DiD = 12.6%, p-value = 0.16). By the endline, administration of IPTp was higher in the intervention than control, with a DiD of 17.6% for IPTp3 (95% confidence interval (CI) - 16.3, 51.5; p-value 0.31) and 20.0% for IPTp4 (95% CI - 7.2, 47.3; p-value = 0.15).
CONCLUSIONS


Community delivery of IPTp could potentially lead to a greater number of IPTp doses delivered, with no apparent decrease in ANC coverage.",2020,"There was a non-statistically significant increase in the proportion of women attending four ANC visits in the intervention compared to control group (DiD = 12.6%, p-value = 0.16).","['pregnant women (IPTp) with', 'Altogether 374 and 360 women were included in the baseline and endline surveys, respectively', 'malaria in pregnancy at the community level in Burkina Faso', '12 health facilities in a 1:1 ratio to either an']","['sulfadoxine-pyrimethamine', 'intervention group (IPTp delivered by CHWs', 'control group (standard practice, with IPTp delivered at HFs', 'IPTp administration by community health workers (CHWs) on the coverage of IPTp and antenatal care (ANC']","['ANC coverage', 'proportion of women attending four ANC visits']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0747820', 'cui_str': 'Malaria, antepartum'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006409', 'cui_str': 'Burkina Faso'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0700599', 'cui_str': 'Pyrimethamine- and sulfadoxine-containing product'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2745948', 'cui_str': 'Juvenile hyaline fibromatosis'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]",,0.0858406,"There was a non-statistically significant increase in the proportion of women attending four ANC visits in the intervention compared to control group (DiD = 12.6%, p-value = 0.16).","[{'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Gutman', 'Affiliation': 'Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, US Centers for Disease Control and Prevention, 1600 Clifton Road, Mailstop H24-3, Atlanta, GA, 30329, USA. fff2@cdc.gov.'}, {'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'Stephens', 'Affiliation': 'The Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Tiendrebeogo', 'Affiliation': 'Jhpiego, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Ousmane', 'Initials': 'O', 'LastName': 'Badolo', 'Affiliation': 'Jhpiego, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Mathurin', 'Initials': 'M', 'LastName': 'Dodo', 'Affiliation': 'Jhpiego, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Burke', 'Affiliation': 'Jhpiego, Baltimore, MD, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Williamson', 'Affiliation': 'Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, US Centers for Disease Control and Prevention, 1600 Clifton Road, Mailstop H24-3, Atlanta, GA, 30329, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Vibbert', 'Affiliation': 'Jhpiego, Baltimore, MD, USA.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Youll', 'Affiliation': ""US President's Malaria Initiative, US Agency for International Development, Washington, D.C., USA.""}, {'ForeName': 'Yacouba', 'Initials': 'Y', 'LastName': 'Savadogo', 'Affiliation': 'National Malaria Control Programme, Ministry of Health, Ouagadougou, Burkina Faso.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Brieger', 'Affiliation': 'Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, US Centers for Disease Control and Prevention, 1600 Clifton Road, Mailstop H24-3, Atlanta, GA, 30329, USA.'}]",Malaria journal,['10.1186/s12936-020-03356-9']
1785,32758267,Carbon ion reirradiation compared to intensity-modulated re-radiotherapy for recurrent head and neck cancer (CARE): a randomized controlled trial.,"BACKGROUND


Intensity-modulated re-radiotherapy (reIMRT) has been established as a standard local treatment option in patients with non-resectable, recurrent head and neck cancer (rHNC). However, the clinical outcome is unfavorable and severe toxicities (≥grade III) occurred in 30-40% of patients. The primary aim of the current trial is to investigate carbon ion reirradiation (reCIRT) compared to reIMRT in patients with rHNC regarding safety/toxicity as well as local control, overall survival (OS), and quality of life (QoL).
METHODS


The present trial will be performed as a single center, two-armed, prospective phase II study. A maximum of 72 patients will be treated with either reIMRT or reCIRT to evaluate severe (≥grade III) treatment-related toxicities (randomization ratio 1:1). The primary target value is to generate less than 35% acute/subacute severe toxicity (≥grade III), according to the Common Terminology Criteria for Adverse Events v5.0, within 6 months after study treatment. The total dose of reirradiation will range between 51 and 60 Gy or Gy (RBE), depending primarily on the radiotherapy interval and the cumulative dose to organs at risk. Individual dose prescription will be at the discretion of the treating radiation oncologist. The local and distant progression-free survival 12 months after reirradiation, the OS, and the QoL are the secondary endpoints of the trial. Explorative trial objectives are the longitudinal investigation of clinical patient-related parameters, tumor parameters on radiological imaging, and blood-based tumor analytics.
DISCUSSION


Recent retrospective studies suggested that reCIRT could represent a feasible and effective treatment modality for rHNC. This current randomized prospective trial is the first to investigate the toxicity and clinical outcome of reCIRT compared to reIMRT in patients with rHNC.
TRIAL REGISTRATION


ClinicalTrials.gov ; NCT04185974 ; December 4th 2019.",2020,"The local and distant progression-free survival 12 months after reirradiation, the OS, and the QoL are the secondary endpoints of the trial.","['patients with non-resectable, recurrent head and neck cancer (rHNC', 'patients with rHNC', '72 patients', 'patients with rHNC regarding', 'recurrent head and neck cancer (CARE']","['reCIRT', 'Carbon ion reirradiation compared to intensity-modulated re-radiotherapy', 'reIMRT', 'reIMRT or reCIRT', 'Intensity-modulated re-radiotherapy (reIMRT', 'carbon ion reirradiation (reCIRT']","['overall survival (OS), and quality of life (QoL', 'subacute severe toxicity', 'severe toxicities (≥grade III', 'safety/toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C4042794', 'cui_str': 'Re Irradiation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.119025,"The local and distant progression-free survival 12 months after reirradiation, the OS, and the QoL are the secondary endpoints of the trial.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Held', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Lang', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Regnery', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Weusthof', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Adriane', 'Initials': 'A', 'LastName': 'Hommertgen', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Jäkel', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Tonndorf-Martini', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Krisam', 'Affiliation': 'Institute of Medical Biometry and Informatics (IMBI), Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Plinkert', 'Affiliation': 'Department of Otorhinolaryngology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Zaoui', 'Affiliation': 'Department of Otorhinolaryngology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Freudlsperger', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Moratin', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Krauss', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Semi B', 'Initials': 'SB', 'LastName': 'Harrabi', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Herfarth', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Debus', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Adeberg', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany. sebastian.adeberg@med.uni-heidelberg.de.'}]","Radiation oncology (London, England)",['10.1186/s13014-020-01625-0']
1786,32758278,"Who knew? The misleading specificity of ""double-blind"" and what to do about it.","BACKGROUND


In randomized trials, the term ""double-blind"" (and its derivatives, single- and triple-blind, fully blind, and partially blind or masked) has no standard or widely accepted definition. Agreement about which groups are blinded is poor, and authors using these terms often do not identify which groups were blinded, despite specific reporting guidelines to the contrary. Nevertheless, many readers assume-incorrectly-that they know which groups are blinded. Thus, the term is ambiguous at best, misleading at worst, and, in either case, interferes with the accurate reporting, interpretation, and evaluation of randomized trials. The problems with the terms have been thoroughly documented in the literature, and many authors have recommended that they be abandoned.
PROPOSAL


We and our co-signers suggest eliminating the use of adjectives that modify ""blinding"" in randomized trials; a trial would be described as either blinded or unblinded. We also propose that authors report in a standard table which groups or individuals were blinded, what they were blinded to, how blinding was implemented, and whether blinding was maintained. Individuals with dual responsibilities, such as caregiving and data collecting, would also be identified. If blinding was compromised, authors should describe the potential implications of the loss of blinding on interpreting the results.
CONCLUSION


""Double blind"" and its derivatives are terms with little to recommend their continued use. Eliminating the use of adjectives that impart a false specificity to the term would reduce misinterpretations, and recommending that authors report who was blinded to what and how in a standard table would require them to be specific about which groups and individuals were blinded.",2020,"We and our co-signers suggest eliminating the use of adjectives that modify ""blinding"" in randomized trials; a trial would be described as either blinded or unblinded.",[],[],[],[],[],[],,0.497131,"We and our co-signers suggest eliminating the use of adjectives that modify ""blinding"" in randomized trials; a trial would be described as either blinded or unblinded.","[{'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Lang', 'Affiliation': 'West China Hospital/Sichuan Medical School Publishing Group, Kirkland, WA, USA. tomlangcom@aol.com.'}, {'ForeName': 'Donna F', 'Initials': 'DF', 'LastName': 'Stroup', 'Affiliation': 'Data for Solutions, Inc., Decatur, GA, USA.'}]",Trials,['10.1186/s13063-020-04607-5']
1787,32758281,"Correction to: A nurse-led health coaching intervention for stroke survivors and their family caregivers in hospital to home transition care in Chongqing, China: a study protocol for a randomized controlled trial.",An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,"['stroke survivors and their family caregivers in hospital to home transition care in Chongqing, China']",['nurse-led health coaching intervention'],[],"[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0630952,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Shuanglan', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, GPO Box 2100, Adelaide, SA, 5001, Australia.'}, {'ForeName': 'Lily Dongxia', 'Initials': 'LD', 'LastName': 'Xiao', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, GPO Box 2100, Adelaide, SA, 5001, Australia. lily.xiao@flinders.edu.au.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Chamberlain', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, GPO Box 2100, Adelaide, SA, 5001, Australia.'}]",Trials,['10.1186/s13063-020-04609-3']
1788,32758282,"Does propolis affect the quality of life and complications in subjects with irritable bowel syndrome (diagnosed with Rome IV criteria)? A study protocol of the randomized, double-blinded, placebo-controlled clinical trial.","BACKGROUND


Irritable bowel syndrome (IBS) is one of the most frequent and recurrent gastrointestinal diseases. However, up to now, no pharmacological agent has been approved to treat IBS. Emerging evidence showed that inflammation has a vital role in enhancing nervous system sensitivity and perception of abdominal pain in subjects with IBS. Propolis is an herbal substance with a broad spectrum of antioxidants, anti-inflammatory, and prebiotic properties, which might exert beneficial effects to reduce the severity of IBS. The current clinical trial aims to evaluate the efficacy of propolis supplementation on IBS.
METHODS


This single-center, randomized, double-blind, placebo-controlled clinical trial will be performed to evaluate the effect of propolis supplementation in adult patients with IBS diagnosed with Rome IV criteria. Fifty-two eligible patients will randomly be allocated to receive a propolis tablet (450 mg, containing 100 mg polyphenol compounds) or identical placebo, twice daily for 6 weeks. The primary outcome of the trial is an improvement in IBS severity from baseline to the sixth week of intervention. The secondary outcomes include the change in weight, waist circumference, and IBS quality of life. We will use the paired sample t test or Mann-Whitney U test for the within-group comparison and independent sample t test or Wilcoxon rank-sum and chi-square test or Fisher's exact test for the between-group comparison. Besides, a multivariable-adjusted mean effect will be computed using the ANCOVA test.
DISCUSSION


We hypothesize that propolis supplementation would be useful for treating IBS through its antioxidants, anti-inflammatory, and prebiotic properties. This trial will show the results of propolis supplementation, whether positive or negative, on IBS. If the current trial confirms our hypothesis, propolis supplementation can be a new choice in adjunctive therapy of IBS.
TRIAL REGISTRATION


Iranian Registry of Clinical Trials IRCT20190708044154N1. Registered on 26 December 2019. Updated on 13 February 2020. https://en.irct.ir/trial/40983 SPONSOR: Tabriz University of Medical Sciences, Tabriz, Iran.",2020,Emerging evidence showed that inflammation has a vital role in enhancing nervous system sensitivity and perception of abdominal pain in subjects with IBS.,"['subjects with irritable bowel syndrome (diagnosed with Rome IV criteria', 'subjects with IBS', 'Fifty-two eligible patients', 'Tabriz University of Medical Sciences, Tabriz, Iran', 'adult patients with IBS diagnosed with Rome IV criteria']","['propolis tablet (450\u2009mg, containing 100\u2009mg polyphenol compounds) or identical placebo', 'https://en.irct.ir/trial/40983', 'propolis supplementation', 'placebo']","['quality of life and complications', 'IBS severity', 'change in weight, waist circumference, and IBS quality of life', 'IBS']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0033488', 'cui_str': 'Propolis'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}]",52.0,0.550332,Emerging evidence showed that inflammation has a vital role in enhancing nervous system sensitivity and perception of abdominal pain in subjects with IBS.,"[{'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Miryan', 'Affiliation': 'Nutrition Research Center, Student Research Committee, Department of Clinical Nutrition, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Pezhman', 'Initials': 'P', 'LastName': 'Alavinejad', 'Affiliation': 'Alimentary Tract Research Center, Ahvaz Imam Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Abbaspour', 'Affiliation': 'Targeted Drug Delivery Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Davood', 'Initials': 'D', 'LastName': 'Soleimani', 'Affiliation': 'Nutritional Sciences Department, School of Nutrition Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ostadrahimi', 'Affiliation': 'Nutrition Research Center, Department of Clinical Nutrition, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. Ostadrahimi@tbzmed.ac.ir.'}]",Trials,['10.1186/s13063-020-04615-5']
1789,32767145,Prospective randomized controlled trial on comparison of standard CO 2  pressure pneumoperitoneum insufflator versus AirSeal®.,"BACKGROUND


AirSeal® is a valve-free insufflation system that enables a stable pneumoperitoneum with continuous smoke evacuation and CO 2  recirculation during laparoscopic surgery. Comparative evidence on the use of AirSeal® and standard CO 2  insufflator in laparoscopic general surgery procedures is scarce. The aim of this study was to compare surgical outcomes between AirSeal® and standard CO 2  insufflators in patients undergoing the most frequently performed laparoscopic procedures.
METHODS


One hundred and ninety-eight patients undergoing elective laparoscopic cholecystectomy, colorectal surgery and hernia repair were randomized to either AirSeal® (group A) or standard pressure CO 2  insufflator (group S). The primary endpoints were operative time and level of postoperative shoulder tip pain (Visual Analog Scale). Secondary outcomes included Clavien-Dindo grade complications, surgical side effect and length of hospital stay.
RESULTS


Patients were randomized to either group A (n = 101) or group S (n = 97) and were analyzed by intention-to-treat. There was no significant difference in mean operative time between the groups (median [IQR]; 71 min [56-94] in group A vs. 69 min [52-93] in group S; p = 0.434). Shoulder tip pain levels were significantly lower in group S (VAS 0 [0-3] in group S vs. 2 [0-4] in group A; p = 0.001). There was no significant difference in complications, surgical side effects (subcutaneous emphysema was not observed in any group) and length of hospital stay.
CONCLUSION


This randomized controlled trial showed that using the AirSeal® system did not reduce operative time and was associated with a higher postoperative shoulder tip pain compared to standard CO 2  insufflator for short elective surgeries. ClinicalTrials.gov (NCT01740011).",2020,"There was no significant difference in complications, surgical side effects (subcutaneous emphysema was not observed in any group) and length of hospital stay.
","['One hundred and ninety-eight patients undergoing elective laparoscopic cholecystectomy, colorectal surgery and hernia repair', 'patients undergoing the most frequently performed laparoscopic procedures']","['AirSeal® and standard CO', 'AirSeal®', 'standard CO 2  pressure pneumoperitoneum insufflator versus AirSeal®', 'standard pressure CO 2  insufflator']","['complications, surgical side effects (subcutaneous emphysema', 'surgical outcomes', 'Clavien-Dindo grade complications, surgical side effect and length of hospital stay', 'Shoulder tip pain levels', 'length of hospital stay', 'mean operative time', 'operative time', 'operative time and level of postoperative shoulder tip pain (Visual Analog Scale']","[{'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0021639', 'cui_str': 'Insufflator'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0038536', 'cui_str': 'Subcutaneous emphysema'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",198.0,0.12362,"There was no significant difference in complications, surgical side effects (subcutaneous emphysema was not observed in any group) and length of hospital stay.
","[{'ForeName': 'Rosalia', 'Initials': 'R', 'LastName': 'Luketina', 'Affiliation': 'Department Hand, Plastic, Reconstructive and Burn Surgery, BG Trauma Center Tuebingen, Eberhard Karls University Tuebingen, Schnarrenbergstr. 95, 72076, Tuebingen, Germany. r_luketina@yahoo.de.'}, {'ForeName': 'Theodore L H', 'Initials': 'TLH', 'LastName': 'Luketina', 'Affiliation': 'Department of Anaesthesia & Intensive Care Medicine, Cantonal Hospital of Muensterlingen, Muensterlingen, Switzerland.'}, {'ForeName': 'Stavros A', 'Initials': 'SA', 'LastName': 'Antoniou', 'Affiliation': 'Department of Surgery, School of Medicine, European University Cyprus, Nicosia, Cyprus.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Köhler', 'Affiliation': 'Department of General and Visceral Surgery, Congregation Hospital (Sisters of Charity), Ordensklinikum Linz, Austria.'}, {'ForeName': 'Sören', 'Initials': 'S', 'LastName': 'Könneker', 'Affiliation': 'Department of Plastic, Aesthetic, Hand and Reconstructive Surgery, Hannover Medical School, Hanover, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Manzenreiter', 'Affiliation': 'Department of Surgery, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Helwig', 'Initials': 'H', 'LastName': 'Wundsam', 'Affiliation': 'Department of General and Visceral Surgery, Congregation Hospital (Sisters of Charity), Ordensklinikum Linz, Austria.'}, {'ForeName': 'Oliver Owen', 'Initials': 'OO', 'LastName': 'Koch', 'Affiliation': 'Department of Surgery, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Knauer', 'Affiliation': 'Breast Center Ostschweiz, Schuppistrasse 10, 9016, St. Gallen, Switzerland.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Emmanuel', 'Affiliation': 'Department of Surgery, Paracelsus Medical University, Salzburg, Austria.'}]",Surgical endoscopy,['10.1007/s00464-020-07846-4']
1790,32767288,Comparison of endoscopic ultrasound-guided fine-needle biopsy versus fine-needle aspiration for genomic profiling and DNA yield in pancreatic cancer: a randomized crossover trial.,"BACKGROUND


National guidelines recommend genomic profiling of tumor tissue to guide precision therapy. We compared the specimen adequacy for genomic profiling and yield of DNA between endoscopic ultrasound (EUS)-guided fine-needle biopsy (FNB) and EUS-guided fine-needle aspiration (FNA).
METHODS


In our tandem, randomized controlled trial, consecutive patients undergoing EUS for evaluation of pancreatic masses underwent both conventional EUS-FNA with a 25-gauge needle and paired EUS-FNB (19 or 22-gauge needle), with the order randomized (EUS-FNA first followed by EUS-FNB, or vice versa). A minimum of one pass with each needle was obtained for histology. Second and third passes were performed to collect DNA. Specimens were evaluated by a cytopathologist blinded to the needle type. Specimen adequacy for genomic profiling was calculated based on FoundationOne clinical diagnostic (CDx) adequacy requirements. We compared the adequacy for genomic profiling DNA (quantity) and histology yields with both needles.
RESULTS


Analysis included 50 patients (25 men; mean age 68 [standard deviation (SD) 13] years), with a mean lesion size of 38 (SD 17) mm; 37 lesions (74 %) were pancreatic ductal adenocarcinoma (PDAC). The mean DNA concentrations in PDAC by FNB and FNA needles were 5.930 (SD 0.881) µg/mL vs. 3.365 (SD 0.788) µg/mL, respectively ( P  = 0.01). The median standardized histology score per pass with EUS-FNB was 5 (sufficient for histology) and for EUS-FNA was 2 (enough for cytology). Specimen adequacy for genomic profiling and yield of DNA was significantly higher with FNB than with FNA needles.
CONCLUSIONS


In this study, adequacy for genomic profiling, DNA, and histology yield were considerably superior using an EUS-FNB needle compared with an EUS-FNA needle.",2020,"In this study, adequacy for genomic profiling, DNA, and histology yield were considerably superior using an EUS-FNB needle compared with an EUS-FNA needle.","['50 patients (25 men; mean age 68 [standard deviation (SD) 13] years), with a mean lesion size of 38 (SD 17) mm; 37 lesions (74\u200a%) were pancreatic ductal adenocarcinoma (PDAC', 'consecutive patients undergoing EUS for evaluation of pancreatic masses underwent both', 'pancreatic cancer']","['conventional EUS-FNA with a 25-gauge needle and paired EUS-FNB (19 or 22-gauge needle', 'endoscopic ultrasound-guided fine-needle biopsy versus fine-needle aspiration', 'endoscopic ultrasound (EUS)-guided fine-needle biopsy (FNB) and EUS-guided fine-needle aspiration (FNA']","['mean DNA concentrations', 'Specimen adequacy for genomic profiling and yield of DNA', 'median standardized histology score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0877425', 'cui_str': 'Mass of pancreas'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C1510483', 'cui_str': 'Fine needle aspiration biopsy - action'}, {'cui': 'C0456638', 'cui_str': '25G'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0085846', 'cui_str': 'Fine needle biopsy'}, {'cui': 'C0450404', 'cui_str': '22G'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1880510', 'cui_str': 'EUS-FNA'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0365319,"In this study, adequacy for genomic profiling, DNA, and histology yield were considerably superior using an EUS-FNB needle compared with an EUS-FNA needle.","[{'ForeName': 'Pujan', 'Initials': 'P', 'LastName': 'Kandel', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, Florida, USA.'}, {'ForeName': 'Aziza', 'Initials': 'A', 'LastName': 'Nassar', 'Affiliation': 'Department of Laboratory Medicine & Pathology, Mayo Clinic, Jacksonville, Florida, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Gomez', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, Florida, USA.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Raimondo', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, Florida, USA.'}, {'ForeName': 'Timothy A', 'Initials': 'TA', 'LastName': 'Woodward', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, Florida, USA.'}, {'ForeName': 'Julia E', 'Initials': 'JE', 'LastName': 'Crook', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Jacksonville, Florida, USA.'}, {'ForeName': 'Natalie S', 'Initials': 'NS', 'LastName': 'Fares', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, Florida, USA.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Wallace', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, Florida, USA.'}]",Endoscopy,['10.1055/a-1223-2171']
1791,32762427,"Medication use, renin-angiotensin system inhibitors, and acute care utilization after hospitalization in patients with chronic kidney disease.","OBJECTIVES


The aims of this secondary analysis were to: (a) characterize medication use following hospital discharge for patients with chronic kidney disease (CKD), and (b) investigate relationships of medication use with the primary composite outcome of acute care utilization 90 days after hospitalization.
METHODS


The CKD-Medication Intervention Trial (CKD-MIT) enrolled acutely ill hospitalized patients with CKD stages 3-5 not dialyzed (CKD 3-5 ND). In this post hoc analysis, data for medication use were characterized, and the relationship of medication use with the primary outcome was evaluated using Cox proportional hazards models.
RESULTS


Participants were taking a mean of 12.6 (standard deviation=5.1) medications, including medications from a wide variety of medication classes. Nearly half of study participants were taking angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARB). ACE inhibitor/ARB use was associated with decreased risk of the primary outcome (hazard ratio=0.51; 95% confidence interval 0.28-0.95;  p =0.03) after adjustment for baseline estimated glomerular filtration rate, age, sex, race, blood pressure, albuminuria, and potential nephrotoxin use.
CONCLUSIONS


A large number, variety, and complexity of medications were used by hospitalized patients with CKD 3-5 ND. ACE inhibitor or ARB use at hospital discharge was associated with a decreased risk of 90-day acute care utilization.",2020,"ACE inhibitor/ARB use was associated with decreased risk of the primary outcome (hazard ratio=0.51; 95% confidence interval 0.28-0.95;  p =0.03) after adjustment for baseline estimated glomerular filtration rate, age, sex, race, blood pressure, albuminuria, and potential nephrotoxin use.
","['acutely ill hospitalized patients with CKD stages 3-5 not dialyzed (CKD 3-5 ND', 'Participants were taking a mean of 12.6 (standard deviation=5.1) medications, including medications from a wide variety of medication classes', 'patients with chronic kidney disease', 'patients with chronic kidney disease (CKD), and (b) investigate relationships of medication use with the primary composite outcome of acute care utilization 90 days after hospitalization']","['ACE inhibitor or ARB', 'renin-angiotensin system inhibitors', 'ACE inhibitor/ARB', 'angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARB']",[],"[{'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517545', 'cui_str': '12.6'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0022709', 'cui_str': 'Dipeptidyl carboxypeptidase I'}]",[],,0.0473132,"ACE inhibitor/ARB use was associated with decreased risk of the primary outcome (hazard ratio=0.51; 95% confidence interval 0.28-0.95;  p =0.03) after adjustment for baseline estimated glomerular filtration rate, age, sex, race, blood pressure, albuminuria, and potential nephrotoxin use.
","[{'ForeName': 'Joshua J', 'Initials': 'JJ', 'LastName': 'Neumiller', 'Affiliation': 'College of Pharmacy and Pharmaceutical Sciences, Washington State University, USA.'}, {'ForeName': 'Kenn B', 'Initials': 'KB', 'LastName': 'Daratha', 'Affiliation': 'School of Anesthesia, Providence Health Care, USA.'}, {'ForeName': 'Radica Z', 'Initials': 'RZ', 'LastName': 'Alicic', 'Affiliation': 'Providence Medical Research Center, Providence Health Care, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Short', 'Affiliation': 'Providence Medical Research Center, Providence Health Care, USA.'}, {'ForeName': 'Haleigh M', 'Initials': 'HM', 'LastName': 'Miller', 'Affiliation': 'Sacred Heart Medical Center, Providence Health Care, USA.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Gregg', 'Affiliation': 'Sacred Heart Medical Center, Providence Health Care, USA.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Gates', 'Affiliation': 'College of Pharmacy and Pharmaceutical Sciences, Washington State University, USA.'}, {'ForeName': 'Cynthia F', 'Initials': 'CF', 'LastName': 'Corbett', 'Affiliation': 'College of Nursing, University of South Carolina, USA.'}, {'ForeName': 'Sterling M', 'Initials': 'SM', 'LastName': 'McPherson', 'Affiliation': 'Providence Medical Research Center, Providence Health Care, USA.'}, {'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Tuttle', 'Affiliation': 'Providence Medical Research Center, Providence Health Care, USA.'}]",Journal of the renin-angiotensin-aldosterone system : JRAAS,['10.1177/1470320320945137']
1792,32762995,"Mapping From Visual Acuity to EQ-5D, EQ-5D With Vision Bolt-On, and VFQ-UI in Patients With Macular Edema in the LEAVO Trial.","OBJECTIVES


Mappings to convert clinical measures to preference-based measures of health such as the EQ-5D-3L are sometimes required in cost-utility analyses. We developed mappings to convert best-corrected visual acuity (BCVA) to the EQ-5D-3L, the EQ-5D-3L with a vision bolt-on (EQ-5D V), and the Visual Functioning Questionnaire-Utility Index (VFQ-UI) in patients with macular edema caused by central retinal vein occlusion.
METHODS


We used data from Lucentis, Eylea, Avastin in vein occlusion (LEAVO), which is a phase-3 randomized controlled trial comparing ranibizumab, aflibercept, and bevacizumab in 463 patients with observations at 6 time points. We estimated adjusted limited dependent variable mixture models consisting of 1 to 4 distributions (components) using BCVA in each eye, age, and sex to predict utility within the components and BCVA as a determinant of component membership. We compared model fit using mean error, mean absolute error, root mean square error, Akaike information criteria, Bayesian information criteria, and visual inspection of mean predicted and observed utilities and cumulative distribution functions.
RESULTS


Mean utility scores were 0.82 for the EQ-5D-3L, 0.79 for the EQ-5D V, and 0.88 for the VFQ-UI. The best-fitting models for the EQ-5D and EQ-5D V had 2 components (with means of approximately 0.44 and 0.85), and the best-fitting model for VFQ-UI had 3 components (with means of approximately 0.95, 0.74, and 0.90).
CONCLUSIONS


Models with multiple components better predict utility than those with single components. This article provides a valuable addition to the literature, in which previous mappings in visual acuity have been limited to linear regressions, resulting in unfounded assumptions about the distribution of the dependent variable.",2020,"Mean utility scores were 0.82 for the EQ-5D-3L, 0.79 for the EQ-5D V, and 0.88 for the VFQ-UI.","['patients with macular edema caused by central retinal vein occlusion', '463 patients with observations at 6 time points', 'Patients With Macular Edema in the LEAVO Trial']","['ranibizumab, aflibercept, and bevacizumab', 'Lucentis, Eylea, Avastin in vein occlusion (LEAVO']","['mean error, mean absolute error, root mean square error, Akaike information criteria, Bayesian information criteria, and visual inspection of mean predicted and observed utilities and cumulative distribution functions', 'Mean utility scores', 'Visual Functioning Questionnaire-Utility Index (VFQ-UI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0154841', 'cui_str': 'Central retinal vein occlusion'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1721374', 'cui_str': 'Lucentis'}, {'cui': 'C3248025', 'cui_str': 'Eylea'}, {'cui': 'C1135130', 'cui_str': 'Avastin'}, {'cui': 'C0948441', 'cui_str': 'Venous occlusion'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C3248025', 'cui_str': 'Eylea'}, {'cui': 'C1135130', 'cui_str': 'Avastin'}, {'cui': 'C0948441', 'cui_str': 'Venous occlusion'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",463.0,0.141225,"Mean utility scores were 0.82 for the EQ-5D-3L, 0.79 for the EQ-5D V, and 0.88 for the VFQ-UI.","[{'ForeName': 'Becky M', 'Initials': 'BM', 'LastName': 'Pennington', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, England, UK. Electronic address: b.pennington@sheffield.ac.uk.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Hernández-Alava', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, England, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Hykin', 'Affiliation': 'National Institute for Health Research Moorfields Biomedical Research Centre, London, England, UK.'}, {'ForeName': 'Sobha', 'Initials': 'S', 'LastName': 'Sivaprasad', 'Affiliation': 'National Institute for Health Research Moorfields Biomedical Research Centre, London, England, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Flight', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, England, UK.'}, {'ForeName': 'Abualbishr', 'Initials': 'A', 'LastName': 'Alshreef', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, England, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Brazier', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, England, UK.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2020.03.008']
1793,32762997,Mimicking Real-Life Decision Making in Health: Allowing Respondents Time to Think in a Discrete Choice Experiment.,"OBJECTIVE


To empirically test the impact of allowing respondents time to think (TTT) about their choice options on the outcomes of a discrete choice experiments (DCE).
METHODS


In total, 613 participants of the Swedish CArdioPulmonary bioImage Study (SCAPIS) completed a DCE questionnaire that measured their preferences for receiving secondary findings of a genetic test. A Bayesian D-efficient design with 60 choice tasks divided over 4 questionnaires was used. Each choice task contained 2 scenarios with 4 attributes: type of disease, disease penetrance probability, preventive opportunities, and effectiveness of prevention. Respondents were randomly allocated to the TTT or no TTT (NTTT) sample. Latent class models (LCMs) were estimated to determine attribute-level values and their relative importance. In addition, choice certainty, attribute-level interpretation, choice consistency, and potential uptake rates were compared between samples.
RESULTS


In the TTT sample, 92% of the respondents (245 of 267) indicated they used the TTT period to (1) read the information they received (72%) and (2) discuss with their family (24%). In both samples, respondents were very certain about their choices. A 3-class LCM was fitted for both samples. Preference reversals were found for 3 of the 4 attributes in one class in the NTTT sample (34% class-membership probability). Relative importance scores of the attributes differed between the 2 samples, and significant scale effects indicating higher choice consistency in TTT sample were found.
CONCLUSIONS


Offering respondents TTT influences decision making and preferences. Developers of future DCEs regarding complex health-related decisions are advised to consider this approach to enhance the validity of the elicited preferences.",2020,"Relative importance scores of the attributes differed between the 2 samples, and significant scale effects indicating higher choice consistency in TTT sample were found.
","['613 participants of the Swedish CArdioPulmonary bioImage Study (SCAPIS) completed a', 'Health']","['TTT or no TTT', 'DCE questionnaire']",['potential uptake rates'],"[{'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",[],613.0,0.0487338,"Relative importance scores of the attributes differed between the 2 samples, and significant scale effects indicating higher choice consistency in TTT sample were found.
","[{'ForeName': 'Jorien', 'Initials': 'J', 'LastName': 'Veldwijk', 'Affiliation': 'Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, The Netherlands; Centre for Research Ethics and Bioethics, Uppsala University, Uppsala, Sweden; Erasmus Choice Modelling Centre, Erasmus University Rotterdam, Rotterdam, The Netherlands. Electronic address: veldwijk@eshpm.eur.nl.'}, {'ForeName': 'Jennifer Viberg', 'Initials': 'JV', 'LastName': 'Johansson', 'Affiliation': 'Centre for Research Ethics and Bioethics, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Donkers', 'Affiliation': 'Erasmus School of Economics, Erasmus University Rotterdam, Rotterdam, The Netherlands; Erasmus Choice Modelling Centre, Erasmus University Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Esther W', 'Initials': 'EW', 'LastName': 'de Bekker-Grob', 'Affiliation': 'Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, The Netherlands; Erasmus Choice Modelling Centre, Erasmus University Rotterdam, Rotterdam, The Netherlands.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2020.02.014']
1794,32763625,Evaluation of impact-shock on gait after the implementation of two different training programs in older adults.,"BACKGROUND


Gait is negatively affected with increasing age. It is widely accepted that training produces physical-functional improvements in older adults, which can be assessed with numerous physical-functional tests. However, very few studies have been carried out using accelerometry to analyse the training effect on kinetic and kinematic variables in older adults, and there is no one that investigate the effects of two different training programs. Therefore, the aim of this study is to analyse the effects of an interval-walking program and a multicomponent program on the acceleration impacts, shock attenuation, step-length, stride frequency, and gait speed in older adults.
METHODS


23 participants were divided into multicomponent training group [n = 12, 7 female, 71.58 (4.56) years] and interval-walking group [n = 11, 6 female, 69.64 (3.56) years]. We evaluated the participants using three triaxial accelerometers, placing one on the distal end of each tibia and one on the forehead.
FINDINGS


After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group. The maximum acceleration values for the head and the stride frequency also increased in the interval-walking group. Lower limb strength improved in both groups.
INTERPRETATION


Given the benefits we found for each of these programs, we encourage their consideration when planning older adults training programs and suggest that multicomponent programs should be introduced prior to the start of walking-based programs.",2020,"After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group.","['participants using three triaxial accelerometers, placing one on the distal end of each tibia and one on the forehead', 'group [n\xa0=\xa012, 7 female, 71.58 (4.56) years] and interval-walking group [n\xa0=\xa011, 6 female, 69.64 (3.56) years', 'older adults', '23 participants']","['multicomponent training', 'interval-walking program and a multicomponent program']","['Lower limb strength', 'maximum acceleration values', 'stride frequency', 'acceleration impacts, shock attenuation, step-length, stride frequency, and gait speed']","[{'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517763', 'cui_str': '4.56'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",23.0,0.0172172,"After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sanchis-Sanchis', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Blasco-Lafarga', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Camacho-García', 'Affiliation': 'Departamento de Comunicaciones, Universitat Politècnica de València, Alcoy, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Encarnación-Martínez', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Pérez-Soriano', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain. Electronic address: pedro.perez-soriano@uv.es.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105131']
1795,32763878,Notifications to Improve Engagement With an Alcohol Reduction App: Protocol for a Micro-Randomized Trial.,"BACKGROUND


Drink Less is a behavior change app that aims to help users in the general adult population reduce hazardous and harmful alcohol consumption. The app includes a daily push notification, delivered at 11 am, asking users to ""Please complete your mood and drinking diaries."" Previous analysis of Drink Less engagement data suggests the current notification strongly influences how users engage with the app in the subsequent hour. To exploit a potential increase of vulnerability of excess drinking and opportunity to engage with the app in the evenings, we changed the delivery time from 11 am to 8 pm. We now aim to further optimise the content and sequence of notifications, testing 30 new evidence-informed notifications targeting the user's perceived usefulness of the app.
OBJECTIVE


The primary objective is to assess whether sending a notification at 8 pm increases behavioral engagement (opening the app) in the subsequent hour. Secondary objectives include comparing the effect of the new bank of messages with the standard message and effect moderation over time. We also aim to more generally understand the role notifications have on the overall duration, depth, and frequency of engagement with Drink Less over the first 30 days after download.
METHODS


This is a protocol for a micro-randomized trial with two additional parallel arms. Inclusion criteria are Drink Less users who (1) consent to participate in the trial; (2) self-report a baseline Alcohol Use Disorders Identification Test score of 8 or above; (3) reside in the United Kingdom; (4) age ≥18 years and; (5) report interest in drinking less alcohol. In the micro-randomized trial, participants will be randomized daily at 8 pm to receive no notification, a notification with text from the new message bank, or the standard message. The primary outcome is the time-varying, binary outcome of ""Did the user open the app in the hour from 8 pm to 9 pm?"". The primary analysis will estimate the marginal relative risk for the notifications using an estimator developed for micro-randomized trials with binary outcomes. Participants randomized to the parallel arms will receive no notifications (Secondary Arm A), or the standard notification delivered daily at 11 am (Secondary Arm B) over 30 days, allowing the comparison of overall engagement between different notification delivery strategies.
RESULTS


Approval was granted by the University College of London's Departmental Research Ethics Committee (CEHP/2016/556) on October 11, 2019, and The London School of Hygiene and Tropical Medicine Interventions Research Ethics Committee (17929) on November 27, 2019. Recruitment began on January 2, 2020, and is ongoing.
CONCLUSIONS


Understanding how push notifications may impact engagement with a behavior change app can lead to further improvements in engagement, and ultimately help users reduce their alcohol consumption. This understanding may also be generalizable to other apps that target a variety of behavior changes.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/18690.",2020,"We now aim to further optimise the content and sequence of notifications, testing 30 new evidence-informed notifications targeting the user's perceived usefulness of the app.
",['Inclusion criteria are Drink Less users who (1) consent to participate in the trial; (2) self-report a baseline Alcohol Use Disorders Identification Test score of 8 or above; (3) reside in the United Kingdom; (4) age ≥18 years and; (5) report interest in drinking less alcohol'],"['asking users to ""Please complete your mood and drinking diaries']","['overall duration, depth, and frequency of engagement with Drink Less', 'new bank of messages with the standard message and effect moderation over time', 'time-varying, binary outcome of ""Did the user open the app in the hour from 8 pm to 9 pm']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2732658', 'cui_str': 'Alcohol use disorders identification test score'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0442598', 'cui_str': 'Bank'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0439227', 'cui_str': 'hour'}]",,0.161916,"We now aim to further optimise the content and sequence of notifications, testing 30 new evidence-informed notifications targeting the user's perceived usefulness of the app.
","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Bell', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Garnett', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, United Kingdom.'}, {'ForeName': 'Tianchen', 'Initials': 'T', 'LastName': 'Qian', 'Affiliation': 'Department of Statistics, Harvard University, Cambridge, MA, United States.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Perski', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, United Kingdom.'}, {'ForeName': 'Henry W W', 'Initials': 'HWW', 'LastName': 'Potts', 'Affiliation': 'Institute of Health Informatics, University College London, London, United Kingdom.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Williamson', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",JMIR research protocols,['10.2196/18690']
1796,32763882,A Novel HIV-1 RNA Testing Intervention to Detect Acute and Prevalent HIV Infection in Young Adults and Reduce HIV Transmission in Kenya: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Detection and management of acute HIV infection (AHI) is a clinical and public health priority, and HIV infections diagnosed among young adults aged 18 to 39 years are usually recent. Young adults with recent HIV acquisition frequently seek care for symptoms and could potentially be diagnosed through the health care system. Early recognition of HIV infection provides considerable individual and public health benefits, including linkage to treatment as prevention, access to risk reduction counseling and treatment, and notification of partners in need of HIV testing.
OBJECTIVE


The Tambua Mapema Plus study aims to (1) test 1500 young adults (aged 18-39 years) identified by an AHI screening algorithm for acute and prevalent (ie, seropositive) HIV, linking all newly diagnosed HIV-infected patients to care and offering immediate treatment; (2) offer assisted HIV partner notification services to all patients with HIV, testing partners for acute and prevalent HIV infection and identifying local sexual networks; and (3) model the potential impact of these two interventions on the Kenyan HIV epidemic, estimating incremental costs per HIV infection averted, death averted, and disability-adjusted life year averted using data on study outcomes.
METHODS


A modified stepped-wedge design is evaluating the yield of this HIV testing intervention at 4 public and 2 private health facilities in coastal Kenya before and after intervention delivery. The intervention uses point-of-care HIV-1 RNA testing combined with standard rapid antibody tests to diagnose AHI and prevalent HIV among young adults presenting for care, employs HIV partner notification services to identify linked acute and prevalent infections, and follows all newly diagnosed patients and their partners for 12 months to ascertain clinical outcomes, including linkage to care, antiretroviral therapy (ART) initiation and virologic suppression in HIV-infected patients, and pre-exposure prophylaxis uptake in uninfected individuals in discordant partnerships.
RESULTS


Enrollment started in December 2017. As of April 2020, 1374 participants have been enrolled in the observation period and 1500 participants have been enrolled in the intervention period, with 13 new diagnoses (0.95%) in the observation period and 37 new diagnoses (2.47%), including 2 AHI diagnoses, in the intervention period. Analysis is ongoing and will include adjusted comparisons of the odds of the following outcomes in the observation and intervention periods: being tested for HIV infection, newly diagnosed with prevalent or acute HIV infection, linked to care, and starting ART by week 6 following HIV diagnosis. Participants newly diagnosed with acute or prevalent HIV infection in the intervention period are being followed for outcomes, including viral suppression by month 6 and month 12 following ART initiation and partner testing outcomes.
CONCLUSIONS


The Tambua Mapema Plus study will provide foundational data on the potential of this novel combination HIV prevention intervention to reduce ongoing HIV transmission in Kenya and other high-prevalence African settings.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03508908; https://clinicaltrials.gov/ct2/show/NCT03508908.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/16198.",2020,"The Tambua Mapema Plus study will provide foundational data on the potential of this novel combination HIV prevention intervention to reduce ongoing HIV transmission in Kenya and other high-prevalence African settings.
","['4 public and 2 private health facilities in coastal Kenya before and after intervention delivery', '1374 participants have been enrolled in the observation period and 1500 participants have been enrolled in the intervention period, with 13 new diagnoses (0.95%) in the observation period and 37 new diagnoses (2.47%), including 2 AHI diagnoses, in the intervention period', 'Participants newly diagnosed with acute or prevalent HIV infection in the intervention period are being followed for outcomes, including viral suppression by month 6 and month 12 following ART initiation and partner testing outcomes', 'young adults aged 18 to 39 years', '1500 young adults (aged 18-39 years) identified by an AHI screening algorithm for acute and prevalent (ie, seropositive) HIV, linking all newly diagnosed HIV-infected patients to care and offering immediate treatment', 'young adults presenting for care, employs HIV partner notification services', 'Young Adults and Reduce HIV Transmission in Kenya', 'Young adults']",['HIV-1 RNA Testing Intervention'],[],"[{'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C2585997', 'cui_str': 'New diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0343752', 'cui_str': 'Acute HIV infection'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0079990', 'cui_str': 'Partner Notification'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0040722', 'cui_str': 'transmission'}]","[{'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],1500.0,0.117879,"The Tambua Mapema Plus study will provide foundational data on the potential of this novel combination HIV prevention intervention to reduce ongoing HIV transmission in Kenya and other high-prevalence African settings.
","[{'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Graham', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Agutu', 'Affiliation': 'Kenya Medical Research Institute - Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'van der Elst', 'Affiliation': 'Kenya Medical Research Institute - Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Amin S', 'Initials': 'AS', 'LastName': 'Hassan', 'Affiliation': 'Kenya Medical Research Institute - Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Evanson', 'Initials': 'E', 'LastName': 'Gichuru', 'Affiliation': 'Kenya Medical Research Institute - Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Mugo', 'Affiliation': 'Kenya Medical Research Institute - Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Farquhar', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Babigumira', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Goodreau', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Deven T', 'Initials': 'DT', 'LastName': 'Hamilton', 'Affiliation': 'Center for Studies in Demography and Ecology, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Thumbi', 'Initials': 'T', 'LastName': ""Ndung'u"", 'Affiliation': 'Africa Health Research Institute, Durban, South Africa.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sirengo', 'Affiliation': 'Department of Health Infrastructure Management, Ministry of Health, Nairobi, Kenya.'}, {'ForeName': 'Wairimu', 'Initials': 'W', 'LastName': 'Chege', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, United States.'}, {'ForeName': 'Eduard J', 'Initials': 'EJ', 'LastName': 'Sanders', 'Affiliation': 'Kenya Medical Research Institute - Wellcome Trust Research Programme, Kilifi, Kenya.'}]",JMIR research protocols,['10.2196/16198']
1797,32763885,Evaluating the Effectiveness of an Intervention Integrating Technology and In-Person Sexual Health Education for Adolescents (In the Know): Protocol for a Cluster Randomized Controlled Trial.,"BACKGROUND


Access to a smartphone is nearly universal among American adolescents, and most of them have used the internet to seek health information. Integrating digital technologies into health program delivery may expand opportunities for youth to receive important health information, yet there are few rigorous studies assessing the effectiveness of this type of intervention.
OBJECTIVE


The purpose of this study is to assess the effectiveness of In the Know (ITK), a program integrating in-person and technology-based sexual health education for underserved adolescents.
METHODS


Youth were engaged in the development of the intervention, including the design of the digital technology and the curriculum content. The intervention focuses on 3 main areas: sexual health and contraceptive use, healthy relationships, and educational and career success. It includes an in-person, classroom component, along with a web-based component to complement and reinforce key content. A cluster randomized controlled trial is in progress among adolescents aged 13-19 years living in Fresno County, California. It is designed to examine the differences in self-reported health and behavioral outcomes among youth in the intervention and control groups at 3 and 9 months. Primary outcomes are condom and contraceptive use or no sex in the past 3 months and use of any clinical health services in the past 3 months. Secondary outcomes include the number of sexual partners in the past 3 months and knowledge of local clinical sexual health services. We will use mixed-effects linear and logistic regression models to assess differences between the intervention and control groups.
RESULTS


Trial enrollment began in October 2017 and ended in March 2020 with a total of 1260 participants. The mean age of the participants is 15.73 (SD 1.83) years, and 69.98% (867/1239) of the participants report being Hispanic or Latino. Study results will be available in 2021.
CONCLUSIONS


ITK has the potential to improve contraceptive and clinic use among underserved youth. This trial will inform future youth-focused health interventions that are considering incorporating technology.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/18060.",2020,It is designed to examine the differences in self-reported health and behavioral outcomes among youth in the intervention and control groups at 3 and 9 months.,"['underserved youth', 'underserved adolescents', 'Youth', 'American adolescents', 'adolescents aged 13-19 years living in Fresno County, California', 'Trial enrollment began in October 2017 and ended in March 2020 with a total of 1260 participants']",['Intervention Integrating Technology and In-Person Sexual Health Education'],"['number of sexual partners in the past 3 months and knowledge of local clinical sexual health services', 'condom and contraceptive use or no sex in the past 3 months and use of any clinical health services']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036879', 'cui_str': 'Sexuality education'}]","[{'cui': 'C0556463', 'cui_str': 'Number of sexual partners'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}]",1260.0,0.0898288,It is designed to examine the differences in self-reported health and behavioral outcomes among youth in the intervention and control groups at 3 and 9 months.,"[{'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Decker', 'Affiliation': 'Department of Epidemiology and Biostatistics, Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Gutmann-Gonzalez', 'Affiliation': 'Philip R Lee Institute for Health Policy Studies, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Melisa', 'Initials': 'M', 'LastName': 'Price', 'Affiliation': 'Philip R Lee Institute for Health Policy Studies, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Romero', 'Affiliation': 'Fresno Economic Opportunities Commission, Fresno, CA, United States.'}, {'ForeName': 'Bhupendra', 'Initials': 'B', 'LastName': 'Sheoran', 'Affiliation': 'Youth Tech Health, ETR, Oakland, CA, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Yarger', 'Affiliation': 'Philip R Lee Institute for Health Policy Studies, Bixby Center for Global Reproductive Health, University of California, San Francisco, San Francisco, CA, United States.'}]",JMIR research protocols,['10.2196/18060']
1798,32763887,A Web-Delivered Acceptance and Commitment Therapy Intervention With Email Reminders to Enhance Subjective Well-Being and Encourage Engagement With Lifestyle Behavior Change in Health Care Staff: Randomized Cluster Feasibility Stud.,"BACKGROUND


Poor mental health and emotional well-being can negatively impact ability to engage in healthy lifestyle behavior change. Health care staff have higher rates of sickness and absence than other public sector staff, which has implications at both individual and societal levels. Individual efforts to self-manage health and well-being which add to the UK mental health prevention agenda need to be supported.
OBJECTIVE


The objective of this study was to establish the feasibility and acceptability of the inclusion of a self-guided, automated, web-based acceptance and commitment therapy intervention in an existing health promotion program, to improve subjective well-being and encourage engagement with lifestyle behavior change.
METHODS


For this 12-week, 4-armed, randomized controlled cluster feasibility study, we recruited participants offline and randomly allocated them to 1 of 3 intervention arms or control (no well-being intervention) using an automated web-based allocation procedure. Eligibility criteria were current health care staff in 1 Welsh health board, age≥18 years, ability to read English, and ability to provide consent. The primary researcher was blinded to cluster allocation. Feasibility outcomes were randomization procedure, acceptance of intervention, and adherence to and engagement with the wider program. We evaluated health and well-being data via self-assessment at 2 time points, registration and postintervention, using the 14-item Warwick-Edinburgh Mental Well-Being Scale, the 4-item Patient Health Questionnaire, and the 7-item Acceptance and Action Questionnaire-Revised.
RESULTS


Of 124 participants who provided consent and were randomly allocated, 103 completed full registration and engaged with the program. Most participants (76/103) enrolled in at least one health behavior change module, and 43% (41/96) of those randomly allocated to an intervention arm enrolled in the well-being module. Adherence and engagement was low (7/103, 6.8%), but qualitative feedback was positive.
CONCLUSIONS


The procedure and randomization process proved feasible, and the addition of the well-being module proved acceptable to health care staff. However, participant engagement was limited, and no one completed the full 12-week program. User feedback should be used to develop the intervention to address poor engagement. Effectiveness should then be evaluated in a full-scale randomized controlled trial, which would be feasible with additional recruitment.
TRIAL REGISTRATION


International Standard Randomised Controlled Trial Number (ISRCTN) 50074817; http://www.isrctn.com/ISRCTN50074817.",2020,"The procedure and randomization process proved feasible, and the addition of the well-being module proved acceptable to health care staff.","['Most participants (76/103) enrolled in at least one health behavior change module, and 43% (41/96) of those randomly allocated to an intervention arm enrolled in the well-being module', 'Health Care Staff', '124 participants who provided consent and were randomly allocated, 103 completed full registration and engaged with the program']","['control (no well-being intervention) using an automated web-based allocation procedure', 'Email Reminders']","['14-item Warwick-Edinburgh Mental Well-Being Scale, the 4-item Patient Health Questionnaire, and the 7-item Acceptance and Action Questionnaire-Revised', 'acceptance of intervention, and adherence to and engagement with the wider program', 'Adherence and engagement']","[{'cui': 'C4505266', 'cui_str': 'One Health Concept'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0013849', 'cui_str': 'Email'}]","[{'cui': 'C4273514', 'cui_str': 'Warwick Edinburgh Mental Well Being Scale'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",,0.109443,"The procedure and randomization process proved feasible, and the addition of the well-being module proved acceptable to health care staff.","[{'ForeName': 'Menna', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, United Kingdom.'}, {'ForeName': 'Nic', 'Initials': 'N', 'LastName': 'Hooper', 'Affiliation': 'Department of Health and Social Sciences, University of the West of England, Bristol, United Kingdom.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'James', 'Affiliation': 'Department of Computer Science, Swansea University, Swansea, United Kingdom.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Scott', 'Affiliation': 'Department of Computer Science, Swansea University, Swansea, United Kingdom.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Bodger', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, United Kingdom.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'John', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, United Kingdom.'}]",JMIR formative research,['10.2196/18586']
1799,32764769,A simple nomogram score for screening patients with type 2 diabetes to detect those with hypertension: A cross-sectional study based on a large community survey in China.,"OBJECTIVES


Compared with unaffected individuals, patients with type 2 diabetes (T2DM) have higher risk of hypertension, and diabetes combined with hypertension can lead to server cardiovascular disease. Therefore, the purpose of this study was to establish a simple nomogram model to identify the determinants of hypertension in patients with T2DM and to quickly calculate the probability of hypertension in individuals with T2DM.
MATERIALS AND METHODS


A total of 643,439 subjects participating in the national physical examination has been recruited in this cross-sectional study. After excluding unqualified subjects, 30,507 adults with T2DM were included in the final analysis. 21,355 and 9,152 subjects were randomly assigned to the model developing group and validation group, respectively, with a ratio of 7:3. The potential risk factors used in this study to assess hypertension in patients with T2DM included questionnaire investigation and physical measurement variables. We used the least absolute shrinkage and selection operator models to optimize feature selection, and the multivariable logistic regression analysis was for predicting model. Discrimination and calibration were assessed using the receiver operating curve (ROC) and calibration curve.
RESULTS


The results showed that the major determinants of hypertension in patients with T2DM were age, gender, drinking, exercise, smoking, obesity and atherosclerotic vascular disease. The area under ROC curve of developing group and validation group are both 0.814, indicating that the prediction model owns high disease recognition ability. The p values of the two calibration curves are 0.625 and 0.445, suggesting that the nomogram gives good calibration.
CONCLUSION


The individualized nomogram model can facilitate improved screening and early identification of patients with hypertension in T2DM. This procedure will be useful in developing regions with high epidemiological risk and poor socioeconomic status just like Urumqi, in Northern China.",2020,"The results showed that the major determinants of hypertension in patients with T2DM were age, gender, drinking, exercise, smoking, obesity and atherosclerotic vascular disease.","['643,439 subjects participating in the national physical examination has been recruited in this cross-sectional study', 'large community survey in China', '30,507 adults with T2DM', '21,355 and 9,152 subjects', 'patients with T2DM and to quickly calculate the probability of hypertension in individuals with T2DM', 'patients with type 2 diabetes (T2DM) have higher risk of hypertension, and diabetes combined with hypertension can lead to server cardiovascular disease', 'screening patients with type 2 diabetes to detect those with hypertension', 'patients with T2DM included questionnaire investigation and physical measurement variables', 'patients with hypertension in T2DM']",[],['receiver operating curve (ROC) and calibration curve'],"[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0009483', 'cui_str': 'Community Surveys'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1705194', 'cui_str': 'Computer network server'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",[],"[{'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}]",643439.0,0.0173558,"The results showed that the major determinants of hypertension in patients with T2DM were age, gender, drinking, exercise, smoking, obesity and atherosclerotic vascular disease.","[{'ForeName': 'Mingyue', 'Initials': 'M', 'LastName': 'Xue', 'Affiliation': 'College of Public Health, Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Hospital of Traditional Chinese Medicine Affiliated to the Fourth Clinical Medical College of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Shuxia', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Center of Health Management, The First Affiliated Hospital, Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Yinxia', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'Center of Health Management, The First Affiliated Hospital, Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Lv', 'Affiliation': 'Hospital of Traditional Chinese Medicine Affiliated to the Fourth Clinical Medical College of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Mingchen', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Yao', 'Affiliation': 'Center of Health Management, The First Affiliated Hospital, Xinjiang Medical University, Urumqi, China.'}]",PloS one,['10.1371/journal.pone.0236957']
1800,32764818,"Does type of active workstation matter? A randomized comparison of cognitive and typing performance between rest, cycling, and treadmill active workstations.","Active workstations are associated with improved health outcomes, but differences in cognitive and typing outcomes between the types of active workstations are unclear. We addressed two main questions: (1) Are there differences in cognitive and typing performance between seated and active workstations? (2) Are there differences in cognitive and typing performance between cycling and treadmill workstations, specifically? Participants included 137 healthy young adults (74 female, mean age = 20.8 years) who completed two sessions. At session one (baseline), all participants completed cognitive and typing tests including the Rey-Auditory Verbal Learning Test, Paced Auditory Serial Addition Test, a typing test, and a flanker task while sitting at rest. At session two, participants were randomized to an active workstation group (treadmill or cycling desk) during which they performed the tests listed above in a randomized fashion, using alternate versions when available. Participants showed significantly better attention and cognitive control scores during the active session as compared to the seated session, but worse verbal memory scores during the active session. Participants were faster and more accurate at typing during the active session relative to the seated session. There were no significant differences between cycling or treadmill workstations on any cognitive or typing outcomes. Improvements during active sessions may be influenced by practice effects, although alternate forms were used when possible. We conclude that active workstations do not seem to largely impact cognitive abilities, with the exception of a slight decrease in verbal memory performance. Findings suggest active workstations, whether walking or cycling, are useful to improve physical activity, particularly when completing tasks that do not require verbal memory recall.",2020,"Active workstations are associated with improved health outcomes, but differences in cognitive and typing outcomes between the types of active workstations are unclear.","['Participants included 137 healthy young adults (74 female, mean age = 20.8 years) who completed two sessions']",['active workstation group (treadmill or cycling desk'],"['verbal memory performance', 'verbal memory scores', 'better attention and cognitive control scores', 'health outcomes']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1736830', 'cui_str': 'Workstation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}]","[{'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",137.0,0.0902228,"Active workstations are associated with improved health outcomes, but differences in cognitive and typing outcomes between the types of active workstations are unclear.","[{'ForeName': 'Kayla M', 'Initials': 'KM', 'LastName': 'Frodsham', 'Affiliation': 'Department of Psychology, Brigham Young University, Provo, UT, United States of America.'}, {'ForeName': 'Nicholas R', 'Initials': 'NR', 'LastName': 'Randall', 'Affiliation': 'Department of Psychology, Brigham Young University, Provo, UT, United States of America.'}, {'ForeName': 'Kaylie A', 'Initials': 'KA', 'LastName': 'Carbine', 'Affiliation': 'Department of Psychology, Brigham Young University, Provo, UT, United States of America.'}, {'ForeName': 'Rebekah E', 'Initials': 'RE', 'LastName': 'Rodeback', 'Affiliation': 'Department of Psychology, Brigham Young University, Provo, UT, United States of America.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'LeCheminant', 'Affiliation': 'Department of Nutrition, Dietetics, and Food Science, Brigham Young University, Provo, UT, United States of America.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Larson', 'Affiliation': 'Department of Psychology, Brigham Young University, Provo, UT, United States of America.'}]",PloS one,['10.1371/journal.pone.0237348']
1801,32764830,Exploring collective emotion transmission in face-to-face interactions.,"Collective emotion is the synchronous convergence of an effective response across individuals toward a specific event or object. Previous studies have focused on the transmission of cyber collective emotion; however, little attention has been paid to the transmission of collective emotion in face-to-face interactions. Using an experimental design, we examined how emotions are transmitted from some members to the whole group in face-to-face situations. We used a news report of a social event as an emotion stimulus to induce anger and disgust in 158 middle school students aged 12 to 15, with an average age of 13.20 years (SD = 0.651) We randomly assigned one-third of the participants to be ""transmitters,"" while the others were ""receivers."" Transmitters shared their feelings with receivers; then, receivers communicated with other group members. The results indicated that negative collective emotions were transmitted from high- to low-intensity members, which converged through the effect of emotional contagion. It accumulated through the effect of an emotional circle, during which the feedback reinforced emotion intensity. The collective emotion transmission model comprised emotion diffusion, contagion, and accumulation. This model elucidates the intrinsic features of collective emotion transmission, enriches the research on collective emotion, and provides theoretical references for monitoring and managing future public events.",2020,"The results indicated that negative collective emotions were transmitted from high- to low-intensity members, which converged through the effect of emotional contagion.","['158 middle school students aged 12 to 15, with an average age of 13.20 years (SD = 0.651']","['transmitters,"" while the others were ""receivers']",['negative collective emotions'],"[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",158.0,0.0145015,"The results indicated that negative collective emotions were transmitted from high- to low-intensity members, which converged through the effect of emotional contagion.","[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Zheng', 'Affiliation': 'Department of Psychology, Weiqing Building, Tsinghua University, Beijing, China.'}, {'ForeName': 'Ailin', 'Initials': 'A', 'LastName': 'Yu', 'Affiliation': 'Department of Psychology, Weiqing Building, Tsinghua University, Beijing, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Fang', 'Affiliation': 'School of Psychology, Capital Normal University, Beijing, China.'}, {'ForeName': 'Kaiping', 'Initials': 'K', 'LastName': 'Peng', 'Affiliation': 'Department of Psychology, Weiqing Building, Tsinghua University, Beijing, China.'}]",PloS one,['10.1371/journal.pone.0236953']
1802,32764861,Comparing Combination Drop Therapy to a Standard Drop Regimen After Routine Cataract Surgery.,"Purpose


To evaluate the efficacy of a combined steroid/antibiotic/non-steroidal anti-inflammatory drop relative to a regimen of multiple drops after cataract surgery.
Setting


Single clinical practice in the USA.
Design


Prospective randomized contralateral eye study.
Methods


Subjects presenting for bilateral cataract surgery were enrolled with contralateral eyes randomly assigned to one of the two groups. Test eyes received a combination therapy (prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac sodium 0.075%) while control eyes received the same medications in separate drops (bromfenac sodium was 0.07%). Subjects were examined 1, 15 and 30 days after surgery. Visual acuities were measured, along with the refraction, intraocular pressure, patient pain and satisfaction, macular thickness and corneal pachymetry. The primary measure of interest was the change in macular thickness from baseline to the 15- and 30-day visits. The frequency and severity of reported ocular adverse events were tabulated for each group and compared.
Results


Thirty-three subjects completed the study. Changes in central macular thickness were similar between groups, with only one control eye exhibiting significant macular edema. No differences in visual acuity, corneal edema, cells or flare were observed between groups. There were eight mild adverse events reported for all eyes of all subjects; the difference in the number of eyes experiencing adverse events was not statistically significantly different between groups (p ≥ 0.05 for all comparisons). While subjective symptoms were similar, all subjects indicated that they preferred the combination drop.
Conclusion


A combination drop showed similar efficacy to multiple drops and was overwhelmingly preferred by subjects.",2020,"No differences in visual acuity, corneal edema, cells or flare were observed between groups.","['Results\n\n\nThirty-three subjects completed the study', 'Methods\n\n\nSubjects presenting for bilateral cataract surgery']","['combination therapy (prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac sodium 0.075%) while control eyes', 'combined steroid/antibiotic/non-steroidal anti-inflammatory']","['refraction, intraocular pressure, patient pain and satisfaction, macular thickness and corneal pachymetry', 'number of eyes experiencing adverse events', 'mild adverse events', 'frequency and severity of reported ocular adverse events', 'visual acuity, corneal edema, cells or flare', 'central macular thickness', 'macular thickness', 'Visual acuities']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0521707', 'cui_str': 'Bilateral cataracts'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0071839', 'cui_str': 'Prednisolone acetate'}, {'cui': 'C0753645', 'cui_str': 'gatifloxacin'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0107211', 'cui_str': 'Bromfenac sodium'}, {'cui': 'C4517416', 'cui_str': '0.075'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}]","[{'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0412514', 'cui_str': 'Corneal pachymetry'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0010037', 'cui_str': 'Corneal edema'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0205099', 'cui_str': 'Central'}]",33.0,0.0395108,"No differences in visual acuity, corneal edema, cells or flare were observed between groups.","[{'ForeName': 'Kerry D', 'Initials': 'KD', 'LastName': 'Solomon', 'Affiliation': 'Carolina Eyecare Physicians, Mt Pleasant, SC, USA.'}, {'ForeName': 'Helga P', 'Initials': 'HP', 'LastName': 'Sandoval', 'Affiliation': 'Carolina Eyecare Physicians, Mt Pleasant, SC, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Potvin', 'Affiliation': 'Science in Vision, Bend, OR, USA.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S260926']
1803,32770431,ACURATE neo: How Is This TAVR Valve Doing to Fit into an Increasingly Crowded Field?,"PURPOSE OF REVIEW


Critical appraisal of the available evidence on the self-expanding ACURATE neo transcatheter heart valve (THV) for the treatment of aortic valve disease.
RECENT FINDINGS


In an investigator-initiated, multicenter, randomized non-inferiority trial with broad inclusion criteria, ACURATE neo failed to meet non-inferiority compared with SAPIEN 3 with regard to a primary composite safety and efficacy endpoint at 30 days. The difference was driven by higher rates of moderate or severe paravalvular regurgitation and higher rates of acute kidney injury. In turn, registry data suggest that the safety and efficacy profile of the ACURATE neo is comparable to that of other commercially available devices. Randomized evidence indicated favorable hemodynamic results with large effective orifice areas and low residual gradients. The self-expanding ACURATE neo THV is associated with higher rates of residual aortic regurgitation compared to the balloon-expandable SAPIEN 3 THV. The supra-annular design with low residual gradients may be advantageous in patients with small anatomy and mild degree of calcification.",2020,The self-expanding ACURATE neo THV is associated with higher rates of residual aortic regurgitation compared to the balloon-expandable SAPIEN 3 THV.,['patients with small anatomy and mild degree of calcification'],[],['residual aortic regurgitation'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}]",[],"[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0003504', 'cui_str': 'Aortic valve regurgitation'}]",,0.0784333,The self-expanding ACURATE neo THV is associated with higher rates of residual aortic regurgitation compared to the balloon-expandable SAPIEN 3 THV.,"[{'ForeName': 'Taishi', 'Initials': 'T', 'LastName': 'Okuno', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, CH-3010, Bern, Switzerland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Lanz', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, CH-3010, Bern, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pilgrim', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, CH-3010, Bern, Switzerland. thomas.pilgrim@insel.ch.'}]",Current cardiology reports,['10.1007/s11886-020-01364-4']
1804,32770443,Intervention Delivery Matters: What Mothers at High Risk for Type 2 Diabetes Want in a Diabetes Prevention Program-Results from a Comparative Effectiveness Trial.,"Participants in the ENCOURAGE Healthy Families Study, a family-focused, modified Diabetes Prevention Program, reported challenges to and preferences for engaging in a diabetes prevention program. Challenges with flexible intervention delivery, accessibility, the traditional group-based format, and Coronavirus Disease 2019 (COVID-19) exposure risk can be mitigated by participant preferences for one-on-one, virtual/online intervention delivery.Trial Registration: ClinicalTrials.gov identifier, NCT01823367.",2020,"Participants in the ENCOURAGE Healthy Families Study, a family-focused, modified Diabetes Prevention Program, reported challenges to and preferences for engaging in a diabetes prevention program.",['Intervention Delivery Matters'],[],[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",[],[],,0.0293589,"Participants in the ENCOURAGE Healthy Families Study, a family-focused, modified Diabetes Prevention Program, reported challenges to and preferences for engaging in a diabetes prevention program.","[{'ForeName': 'Kelly N B', 'Initials': 'KNB', 'LastName': 'Palmer', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, USA. kpalmer1@arizona.edu.'}, {'ForeName': 'Valene E', 'Initials': 'VE', 'LastName': 'Garr Barry', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Marrero', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, USA.'}, {'ForeName': 'Brett M', 'Initials': 'BM', 'LastName': 'McKinney', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, USA.'}, {'ForeName': 'Anne N', 'Initials': 'AN', 'LastName': 'Graves', 'Affiliation': 'YMCA of Greater Indianapolis, Indianapolis, USA.'}, {'ForeName': 'Chelsy K', 'Initials': 'CK', 'LastName': 'Winters', 'Affiliation': 'YMCA of Greater Indianapolis, Indianapolis, USA.'}, {'ForeName': 'Tamara S', 'Initials': 'TS', 'LastName': 'Hannon', 'Affiliation': 'Department of Pediatrics, Indiana University School of Medicine, Indianapolis, USA.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00891-1']
1805,32768874,Intermittent Motivational Interviewing and Transdiagnostic CBT for Anxiety: A Randomized Controlled Trial.,"Recent meta-analytic findings suggest that Motivational Interviewing (MI) used as an adjunct to Cognitive Behavior Therapy (CBT) for anxiety disorders improves overall treatment outcomes (Marker & Norton, 2018). However, when used as a prelude to CBT, MI significantly increases the length of treatment and numerous studies note that the effectiveness of pre-treatment MI subsides over time. The current study adapted an already established 12-session transdiagnostic CBT protocol (tCBT, Norton, 2012) to include one hour of MI spread across four sessions of tCBT (sessions 1, 3, 8, and 10) at 15 minutes each, with the option of including additional MI if resistance arose in therapy. Thirty-six treatment seeking adults with principal anxiety disorder diagnosis were randomly assigned to receive intermittent MI and tCBT (iMI + tCBT) or tCBT and psychoeducation. Results indicated that the iMI + tCBT condition significantly outperformed the tCBT condition on several primary outcome variables. While no significant difference was found between the two groups on clinician rated scores of participant principal anxiety disorder, differences were found on a composite index of participants' self-report measures of symptom improvement, and on clinician rated scores of global psychiatric functioning. These effects were not moderated by baseline motivation or baseline ambivalence. The study also found that the iMI + tCBT condition showed significantly greater improvement to comorbid conditions and greater reduction in self-report depressive symptoms. The inclusion of MI did not impact participant drop out. This study provides further support for integrating MI and tCBT and highlights that even small doses of MI can improve treatment outcomes, without increasing length of usual therapy. Limitations and future research options are also discussed.",2020,"While no significant difference was found between the two groups on clinician rated scores of participant principal anxiety disorder, differences were found on a composite index of participants' self-report measures of symptom improvement, and on clinician rated scores of global psychiatric functioning.","['for Anxiety', 'Thirty-six treatment seeking adults with principal anxiety disorder diagnosis']","['Intermittent Motivational Interviewing and Transdiagnostic CBT', 'Cognitive Behavior Therapy (CBT', 'Motivational Interviewing (MI', 'intermittent MI and tCBT (iMI\u202f+\u202ftCBT) or tCBT and psychoeducation']","['self-report depressive symptoms', ""composite index of participants' self-report measures of symptom improvement, and on clinician rated scores of global psychiatric functioning""]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0340305', 'cui_str': 'Myocardial Infarction, Inferior Wall'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}]",36.0,0.0207886,"While no significant difference was found between the two groups on clinician rated scores of participant principal anxiety disorder, differences were found on a composite index of participants' self-report measures of symptom improvement, and on clinician rated scores of global psychiatric functioning.","[{'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Marker', 'Affiliation': 'Monash University, Australia.'}, {'ForeName': 'Bronte E', 'Initials': 'BE', 'LastName': 'Corbett', 'Affiliation': 'Monash University, Australia.'}, {'ForeName': 'Sean P A', 'Initials': 'SPA', 'LastName': 'Drummond', 'Affiliation': 'Monash University, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Norton', 'Affiliation': 'Monash University, Australia. Electronic address: Peter.Norton@monash.edu.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102276']
1806,32768938,Yidu-toxicity blocking lung decoction ameliorates inflammation in severe pneumonia of SARS-COV-2 patients with Yidu-toxicity blocking lung syndrome by eliminating IL-6 and TNF-a.,"The present study investigates the differences in inflammatory agents alterations, immune function, and leukocyte differential count evaluation in severe pneumonia of SARS-COV-2 patients with Yidu-toxicity blocking lung syndrome after the recommended Chinese medicine prescription of Yidu-toxicity blocking lung decoction. A total of 40 patients with yidu-toxicity blocking lung syndrome, diagnosed as severe pneumonia of SARS-COV-2 following the latest Chinese national recommendations for the diagnosis and treatment of pneumonia caused by SARS-COV-2 (the 5th edition), were recruited. They were randomly divided into the pure western medicine therapy group (PWM) and integrated into Chinese and Western medicine therapy group (ICW). The general strategies were given to both groups according to the national recommendations, and the ICW group was given Yidu-toxicity blocking lung decoction extraorally. A radioimmunoassay method was adopted to detect the content of IL-6, IL-8,IL-2R,TNF-α, procalcitonin (PCT) and high-sensitivity C-reactive protein (hs-CRP) in sera. Flow cytometry was used to determine the peripheral blood lymphocyte subsets (the levels of CD3+, CD4+, CD8+, and the ratios of CD4+/CD8+). The white blood cell counts (WBC#), neutrophils count(N#), and lymphocyte counts (L#) were measured using a fully automatic blood rheological instrument. The t-test or Rank Sum Test and Spearman analysis were conducted to evaluate the differences. The results showed that IL-6 (P = 0.013) and TNF-α (P = 0.035) levels in the PWM group were significantly higher than those in the ICW group after treatment. Infection related indicators such as WBC#, N#, L#, hs-CRP showed no differences. The analysis showed that there was no statistical difference in the values of CD4 and CD8 between the two groups. By the end of Day 29, all patients were discharged and the final cure rate for both group were 100 %. Taken together, we conclude that Yidu-toxicity blocking lung decoction could relieve inflammation of SARS-COV-2 patients with yidu-toxicity blocking lung syndrome by eliminating inflammatory agents. CM can serve as a complementary medication to western medicine, which should be highlighted in clinical settings.",2020,The results showed that IL-6 (P = 0.013) and TNF-α (P = 0.035) levels in the PWM group were significantly higher than those in the ICW group after treatment.,"['severe pneumonia of SARS-COV-2 patients with Yidu-toxicity blocking lung syndrome', '40 patients with yidu-toxicity blocking lung syndrome, diagnosed as severe pneumonia of SARS-COV-2 following the latest Chinese national recommendations for the diagnosis and treatment of pneumonia caused by SARS-COV-2 (the 5th edition), were recruited', 'severe pneumonia of SARS-COV-2 patients with Yidu-toxicity blocking lung syndrome after the recommended Chinese medicine prescription of Yidu-toxicity blocking lung decoction']","['ICW', 'pure western medicine therapy group (PWM) and integrated into Chinese and Western medicine therapy group (ICW', 'ICW group was given Yidu-toxicity blocking lung decoction extraorally', 'Yidu-toxicity blocking lung decoction']","['TNF-α', 'final cure rate', 'content of IL-6, IL-8,IL-2R,TNF-α, procalcitonin (PCT) and high-sensitivity C-reactive protein (hs-CRP', 'values of CD4 and CD8', 'white blood cell counts (WBC#), neutrophils count(N#), and lymphocyte counts (L', 'IL-6', 'peripheral blood lymphocyte subsets (the levels of CD3+, CD4+, CD8+, and the ratios of CD4+/CD8']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]","[{'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0079720', 'cui_str': 'Lymphocyte Subpopulations'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",40.0,0.0200254,The results showed that IL-6 (P = 0.013) and TNF-α (P = 0.035) levels in the PWM group were significantly higher than those in the ICW group after treatment.,"[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Chinese Medicine, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China. Electronic address: zhaojie0506888@126.com.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of General Surgery, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Chenghua', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Chinese Medicine, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'Department of Pharmacy, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Cao', 'Affiliation': 'Department of Orthopaedic, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Taohua', 'Initials': 'T', 'LastName': 'Wei', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei 230022, China.'}, {'ForeName': 'Qiaoxue', 'Initials': 'Q', 'LastName': 'Ji', 'Affiliation': 'Department of Chinese Medicine, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Wanqun', 'Initials': 'W', 'LastName': 'Zheng', 'Affiliation': 'Department of Chinese Medicine, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Jiali', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Chinese Medicine, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Chinese Medicine, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Institute for Medical Virology, Goethe University Frankfurt am Main, Frankfurt 60596, Germany.'}]",Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie,['10.1016/j.biopha.2020.110436']
1807,32768992,Cannabis use in patients 3 months after ceasing nabiximols for the treatment of cannabis dependence: Results from a placebo-controlled randomised trial.,"INTRODUCTION AND AIMS


Previous studies suggest cannabinoid agonist treatment is effective in reducing cannabis use in dependent treatment seekers, however few studies have reported on post-treatment outcomes. We examine cannabis use outcomes 12 weeks after cessation of treatment from a randomised placebo-controlled trial of nabiximols for the treatment of cannabis dependence.
METHOD


128 participants received either nabiximols (n = 61) or placebo (n = 67) for 12 weeks, in combination with psychosocial interventions. Self-reported number of days of cannabis use in the previous 28 days was measured at baseline, 4, 8, and 12 weeks (end of treatment) and again at 24 weeks (3 months after treatment ceased). Urinalysis was used to confirm self-report data at Week 24 interview.
RESULTS


A factorial mixed-effects model for repeated measures regression revealed that the nabiximols group used cannabis on 6.8 fewer days in the previous 28 days at week 12 (end of treatment) than the placebo group (p = 0.002, CI: 2.1,11.4), and 6.7 fewer days in the previous 28 days at the week-24 follow-up than the placebo group (p = 0.006, CI: 1.4,12.1). A significantly higher proportion of the nabiximols group (14/61; 23 %) than the placebo group (6/67; 9%) reported abstinence from cannabis in the previous 28 days at the week-24 research interview OR=3.0, CI: 1.1, 9.1; p=0.035, NNT=8, CI: 4, 71).
DISCUSSIONS AND CONCLUSIONS


The benefits of treatment incorporating nabiximols with psychosocial interventions in reducing cannabis use appears to persist for up to 3 months after the cessation of treatment. A stepped care model of treatment is proposed.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ACTRN12616000103460) https://www.anzctr.org.au.",2020,"A significantly higher proportion of the nabiximols group (14/61; 23 %) than the placebo group (6/67; 9%) reported abstinence from cannabis in the previous 28 days at the week-24 research interview OR=3.0, CI: 1.1, 9.1; p=0.035, NNT=8, CI: 4, 71).
","['patients 3 months after ceasing nabiximols for the treatment of cannabis dependence', '128 participants received either nabiximols (n = 61) or']","['nabiximols with psychosocial interventions', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C2347556', 'cui_str': 'nabiximols'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006870', 'cui_str': 'Cannabis dependence'}]","[{'cui': 'C2347556', 'cui_str': 'nabiximols'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],128.0,0.260502,"A significantly higher proportion of the nabiximols group (14/61; 23 %) than the placebo group (6/67; 9%) reported abstinence from cannabis in the previous 28 days at the week-24 research interview OR=3.0, CI: 1.1, 9.1; p=0.035, NNT=8, CI: 4, 71).
","[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Lintzeris', 'Affiliation': 'Drug and Alcohol Services, South East Sydney Local Health District, NSW, Australia; Division Addiction Medicine, Faculty Medicine and Health, University of Sydney, NSW, Australia; NSW Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Australia. Electronic address: Nicholas.lintzeris@health.nsw.gov.au.'}, {'ForeName': 'Llewellyn', 'Initials': 'L', 'LastName': 'Mills', 'Affiliation': 'Drug and Alcohol Services, South East Sydney Local Health District, NSW, Australia; Division Addiction Medicine, Faculty Medicine and Health, University of Sydney, NSW, Australia; NSW Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Dunlop', 'Affiliation': 'NSW Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Australia; Drug and Alcohol Services, Hunter New England Local Health District, NSW, Australia; Priority Research Centre for Brain and Mental Health, School of Medicine and Public Health, University of Newcastle, NSW, Australia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Copeland', 'Affiliation': 'University of New South Wales, NSW, Australia.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Mcgregor', 'Affiliation': 'Lambert Initiative Cannabinoid Therapeutics, University of Sydney, NSW, Australia.'}, {'ForeName': 'Raimondo', 'Initials': 'R', 'LastName': 'Bruno', 'Affiliation': 'University of Tasmania, TAS, Australia.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Kirby', 'Affiliation': 'National Health and Medical Research Council, Clinical Trials Centre, Faculty Medicine and Public Health, University of Sydney, NSW, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Montebello', 'Affiliation': 'Drug and Alcohol Services, South East Sydney Local Health District, NSW, Australia; Division Addiction Medicine, Faculty Medicine and Health, University of Sydney, NSW, Australia; NSW Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Australia; University of New South Wales, NSW, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'NSW Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Australia; Drug and Alcohol Services, Hunter New England Local Health District, NSW, Australia.'}, {'ForeName': 'Meryem', 'Initials': 'M', 'LastName': 'Jefferies', 'Affiliation': 'NSW Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Australia; Drug Health, Western Sydney Local Health District, NSW, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kevin', 'Affiliation': 'Lambert Initiative Cannabinoid Therapeutics, University of Sydney, NSW, Australia.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Bhardwaj', 'Affiliation': 'Drug and Alcohol Services, South East Sydney Local Health District, NSW, Australia; Division Addiction Medicine, Faculty Medicine and Health, University of Sydney, NSW, Australia; National Health and Medical Research Council, Clinical Trials Centre, Faculty Medicine and Public Health, University of Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108220']
1808,32769505,"Effects of adding a combined femoral and sciatic nerve block with levobupivacaine and clonidine to general anaesthesia in femoropopliteal bypass surgery: A randomised, double-blind, controlled trial.","BACKGROUND


Adding a regional block to general anaesthesia can prevent postoperative pain and improve peripheral circulation.
OBJECTIVE


To seek improved postoperative analgesia and care due to a long-acting combined femoral and sciatic nerve block in patients undergoing femoropopliteal bypass surgery.
DESIGN


A randomised, double-blind, controlled trial.
SETTING


Vascular surgery unit of a French university hospital.
PATIENTS


Forty-four adults scheduled for bypass surgery under general anaesthesia.
INTERVENTION


Patients were allocated to receive either an active nerve block with 20 ml of 0.375% levobupivacaine and clonidine 0.5 μg kg, or a simulated (sham) block only, but with local anaesthesia of the skin, before general anaesthesia. General anaesthesia was standardised with propofol, then sevoflurane and sufentanil adjusted according to clinical need. Postoperative analgesia was standardised with paracetamol 1 g every 6 h, and intravenous morphine, initially titrated in the postanaesthesia care unit and then patient-controlled. Oral analgesics were repeated up to day 3.
MAIN OUTCOME MEASURES


The primary outcome was morphine consumption during the first 24 postoperative hours. In a subgroup of postoperative patients distal tissue oxygen saturation was recorded at the lateral side of the blocked calf.
RESULTS


Patients in the active group received less intra-operative sufentanil (median dose 25 vs. 41 μg), needed less morphine during the first 24 h (15 vs. 27 mg) and 72 (20 vs. 35 mg) postoperative hours, than in the control group. They also had less pain on movement, but pain at rest, the tissue oxygen saturation and other rehabilitation outcomes were unaffected by the treatment. Tolerance outcomes were also similar between groups.
CONCLUSION


Combining the two regional blocks improves the quality of postoperative care in this frail population, probably by reducing the amount of peri-operative opioid.
TRIAL REGISTRATION


ClinicalTrials.gov (ref. NCT01785693).",2020,"They also had less pain on movement, but pain at rest, the tissue oxygen saturation and other rehabilitation outcomes were unaffected by the treatment.","['patients undergoing femoropopliteal bypass surgery', 'Forty-four adults scheduled for bypass surgery under general anaesthesia', 'femoropopliteal bypass surgery', 'Vascular surgery unit of a French university hospital']","['sevoflurane and sufentanil', 'active nerve block with 20\u200aml of 0.375% levobupivacaine and clonidine 0.5\u200aμg\u200akg, or a simulated (sham) block only, but with local anaesthesia of the skin, before general anaesthesia', 'paracetamol', 'long-acting combined femoral and sciatic nerve block', 'levobupivacaine and clonidine', 'propofol', 'morphine']","['Postoperative analgesia', 'pain on movement, but pain at rest, the tissue oxygen saturation and other rehabilitation outcomes', 'postoperative patients distal tissue oxygen saturation', 'quality of postoperative care', 'morphine consumption', 'intra-operative sufentanil', 'Tolerance outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0190932', 'cui_str': 'Femoral-popliteal artery bypass graft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1536078', 'cui_str': 'Bypass surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0042381', 'cui_str': 'Vascular surgery procedure'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C4517455', 'cui_str': '0.375'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0394735', 'cui_str': 'Injection of anesthetic agent into sciatic nerve'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0600378', 'cui_str': 'Rehabilitation Outcome'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0032786', 'cui_str': 'Postoperative care'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",44.0,0.534089,"They also had less pain on movement, but pain at rest, the tissue oxygen saturation and other rehabilitation outcomes were unaffected by the treatment.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Charvin', 'Affiliation': 'From the CHU Clermont-Ferrand, Médecine Péri-Opératoire (MC, FL, PJ, A-LC, EF); Université Clermont-Auvergne (EF); CHU Clermont-Ferrand, Unité de Biostatistiques, Direction de la Recherche Clinique et des Innovations (BP); CHU Clermont-Ferrand, Centre de Pharmacologie Clinique (CD); and INSERM, CIC1405 & UMR1107, Clermont-Ferrand, France (CD).'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Longeras', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Jouve', 'Affiliation': ''}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Cherprenet', 'Affiliation': ''}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Futier', 'Affiliation': ''}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Dualé', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001263']
1809,32590402,Prehospital Administration of Unfractionated Heparin in ST-Segment Elevation Myocardial Infarction Is Associated With Improved Long-Term Survival.,"OBJECTIVE


Administration of unfractionated heparin to STEMI patients by the ambulance service is an established practice in Scotland, but the efficacy is unknown. We studied the effects of unfractionated heparin in STEMI patients treated by primary percutaneous coronary intervention, on infarct artery patency and mortality.
METHODS AND RESULTS


Consecutive patients (n = 1000) admitted to Ninewells Hospital, Dundee, from 2010 to 2014 for primary percutaneous coronary intervention were allocated to 2 groups: 437 (44%) prehospital heparin (PHH) administered by paramedics, and 563 (56%) in-hospital heparin. A trained medical student assessed coronary flow at presentation and collected the data. Mortality status was ascertained at 30 days and 5 years. Cox proportional hazards regression models were generated. The patient groups were similar, although PHH had shorter symptom onset-treatment time (187 vs. 251 minutes, P < 0.001) and less cardiogenic shock (3.9% vs. 8.0%, P = 0.008). Initial coronary flow was not different between the groups. Thirty day mortality in PHH was 2.5% versus 8.3%, P < 0.001. Independent predictors of 30-day mortality were age (odds ratio 1.07, 95% CI 1.04-1.09), cardiogenic shock (5.97, 3.33-10.69), radial access (0.53, 0.28-0.98), and PHH (0.33, 0.17-0.66). Five-year mortality in PHH was 13.0% versus 21.6%, P < 0.001. Significant predictors of long-term mortality were age (1.07, 1.06-1.09), cardiogenic shock (3.40, 2.23-5.17), and PHH (0.68, 0.49-0.96).
CONCLUSIONS


PHH was associated with reduced short- and long-term mortality after adjusting for important potential confounders.",2020,"Thirty day mortality in PHH was 2.5% versus 8.3%, P < 0.001.","['Consecutive patients (n = 1000) admitted to Ninewells Hospital, Dundee, from 2010 to 2014 for primary percutaneous coronary intervention were allocated to 2 groups: 437 (44', 'STEMI patients treated by primary percutaneous coronary intervention, on infarct artery patency and mortality']","['prehospital heparin (PHH', 'unfractionated heparin', 'Unfractionated Heparin']","['Mortality status', 'Thirty day mortality in PHH', 'long-term mortality', 'shorter symptom onset-treatment time', 'Initial coronary flow', 'short- and long-term mortality', 'radial access', '30-day mortality', 'cardiogenic shock']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}]",1000.0,0.058961,"Thirty day mortality in PHH was 2.5% versus 8.3%, P < 0.001.","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McGinley', 'Affiliation': 'University of Dundee, Ninewells Hospital and Medical School, Dundee, United Kingdom.'}, {'ForeName': 'Ify R', 'Initials': 'IR', 'LastName': 'Mordi', 'Affiliation': 'University of Dundee, Ninewells Hospital and Medical School, Dundee, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kell', 'Affiliation': 'Scottish Ambulance Service, Edinburgh, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Currie', 'Affiliation': 'Department of Cardiology, Ninewells Hospital and Medical School, Dundee, United Kingdom.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Hutcheon', 'Affiliation': 'Department of Cardiology, Ninewells Hospital and Medical School, Dundee, United Kingdom.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Koch', 'Affiliation': 'Department of Cardiology, Ninewells Hospital and Medical School, Dundee, United Kingdom.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Martin', 'Affiliation': 'Department of Cardiology, Ninewells Hospital and Medical School, Dundee, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Irving', 'Affiliation': 'Department of Cardiology, Ninewells Hospital and Medical School, Dundee, United Kingdom.'}]",Journal of cardiovascular pharmacology,['10.1097/FJC.0000000000000865']
1810,31810854,Transcutaneous Tibial Nerve Stimulation for Treating Neurogenic Lower Urinary Tract Dysfunction: A Pilot Study for an International Multicenter Randomized Controlled Trial.,"BACKGROUND


Tibial nerve stimulation (TNS) is an effective and safe treatment for idiopathic lower urinary tract dysfunction (LUTD), but its value in neurological patients is unclear.
OBJECTIVE


To test the feasibility, acceptability, and safety of a randomized, sham-controlled, double-blind transcutaneous TNS (TTNS) setup for treating neurogenic LUTD.
DESIGN, SETTING, AND PARTICIPANTS


A pilot study including nine patients with refractory neurogenic LUTD investigated prospectively at a university neuro-urology department.
INTERVENTION


Randomized, sham-controlled, double-blind verum and sham TTNS was performed for 30min twice a week, for 6 wks.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Outcomes were feasibility, acceptability, and safety of the TTNS protocol. Secondarily, potential efficacy was investigated. Descriptive statistics were used.
RESULTS AND LIMITATIONS


All procedures were feasible and well tolerated by all nine patients. Using verum TTNS, a motor response could be triggered in all patients and a sensory response in all but one. At the beginning and end of treatment, seven and six (78% and 67%) patients believed to receive verum TTNS, and five and six (56% and 67%) correctly guessed their group allocation, respectively. No treatment-related adverse events occurred. A comparison of baseline versus 6 wks of verum and sham TTNS led to relevant symptom and functional changes in only a limited number of piloted patients.
CONCLUSIONS


Verum and sham TTNS combined with the blinding procedures proved feasible and safe. Both interventions and procedures, as well as the randomization process, were well accepted by the patients. While the subsensory threshold TTNS approach in combination with the sham condition is advantageous for patients' blinding, the clinical findings raised some doubt regarding sufficient TNS. Hence, relevant methodological adjustments concerning the adequate stimulation current and corresponding sham condition are needed before starting randomized controlled trials to clarify the value and role of TTNS in neuro-urology.
PATIENT SUMMARY


Transcutaneous tibial nerve stimulation is a promising treatment option for neurogenic lower urinary tract dysfunction, but methodological adjustments in treatment application are required before further prospective studies can be initiated.",2020,No treatment-related adverse events occurred.,"['nine patients with refractory neurogenic LUTD investigated prospectively at a university neuro-urology department', 'Treating Neurogenic Lower Urinary Tract Dysfunction']","['Tibial nerve stimulation (TNS', 'Transcutaneous Tibial Nerve Stimulation', 'Transcutaneous tibial nerve stimulation', 'sham-controlled, double-blind verum and sham TTNS', 'verum and sham TTNS', 'sham-controlled, double-blind transcutaneous TNS (TTNS']","['feasible and safe', 'feasibility, acceptability, and safety', 'feasible and well tolerated', 'feasibility, acceptability, and safety of the TTNS protocol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0729866', 'cui_str': 'Lower urinary tract structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0587531', 'cui_str': 'Urology department'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0045733', 'cui_str': '2-(4-toluidino)-6-naphthalenesulfonic acid'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0045733', 'cui_str': '2-(4-toluidino)-6-naphthalenesulfonic acid'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]",9.0,0.128069,No treatment-related adverse events occurred.,"[{'ForeName': 'Jure', 'Initials': 'J', 'LastName': 'Tornic', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Martina D', 'Initials': 'MD', 'LastName': 'Liechti', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Stalder', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Birkhäuser', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'van der Lely', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Leitner', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Mehnert', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Kessler', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland. Electronic address: tkessler@gmx.ch.'}]",European urology focus,['10.1016/j.euf.2019.11.008']
1811,32772246,Increased fascicle length but not patellar tendon stiffness after accentuated eccentric-load strength training in already-trained men.,"PURPOSE


This study examined whether additional external load during the eccentric phase of lower limb strength training exercises led to greater adaptations in knee extensor strength, muscle architecture, and patellar tendon properties than traditional concentric-eccentric training in already-trained men.
METHODS


Twenty-eight men accustomed to strength training were randomized to undertake 10 weeks of supervised traditional (TRAD) or accentuated eccentric loading (AEL) or continue their habitual unsupervised (CON) strength training. TRAD and AEL trained 2∙week -1  with a six-repetition maximum (RM) session and a ten-RM session. TRAD used the same external load in both concentric and eccentric phases, while AEL used 40% greater load during the eccentric than concentric phase. Tests were performed at pre- and post-training, including: maximum unilateral isokinetic (30°·s -1 ) concentric, eccentric and isometric torques by isokinetic dynamometry, unilateral isometric ramp contractions with muscle-tendon ultrasound imaging to measure tendon stiffness and hysteresis, and resting vastus lateralis and medialis fascicle angle and length measured by extended-field-of-view ultrasound.
RESULTS


After training, both TRAD and AEL significantly increased maximum concentric and isometric torque (p < 0.05), but only AEL increased eccentric torque (AEL: + 10 ± 9%, TRAD: + 4 ± 9%) and vastus lateralis (AEL: + 14 ± 14%, TRAD: + 1 ± 10%) and medialis (AEL: + 19 ± 8%, TRAD: + 5 ± 11%) fascicle length.
CONCLUSION


Both TRAD and AEL increased maximum knee extensor strength but only AEL increased VL and VM fascicle length. Neither training program promoted changes in fascicle angle or changes in patellar tendon properties in our already-trained men.",2020,"After training, both TRAD and AEL significantly increased maximum concentric and isometric torque (p < 0.05), but only AEL increased eccentric torque (AEL: + 10 ± 9%, TRAD: + 4 ± 9%) and vastus lateralis (AEL: + 14 ± 14%, TRAD: + 1 ± 10%) and medialis (AEL: + 19 ± 8%, TRAD: + 5 ± 11%) fascicle length.
CONCLUSION


","['already-trained men', 'Twenty-eight men accustomed to strength training']","['supervised traditional (TRAD) or accentuated eccentric loading (AEL) or continue their habitual unsupervised (CON) strength training', 'maximum unilateral isokinetic (30°·s -1 ) concentric, eccentric and isometric torques by isokinetic dynamometry, unilateral isometric ramp contractions with muscle-tendon ultrasound imaging to measure tendon stiffness and hysteresis, and resting vastus lateralis and medialis fascicle angle and length measured by extended-field-of-view ultrasound', 'traditional concentric-eccentric training']","['maximum knee extensor strength', 'eccentric torque (AEL', 'maximum concentric and isometric torque', 'Increased fascicle length', 'fascicle angle or changes in patellar tendon properties', 'knee extensor strength, muscle architecture, and patellar tendon properties', 'VL and VM fascicle length']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1997416', 'cui_str': 'Accentuated'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0034646', 'cui_str': 'Ramp'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}]",,0.0128459,"After training, both TRAD and AEL significantly increased maximum concentric and isometric torque (p < 0.05), but only AEL increased eccentric torque (AEL: + 10 ± 9%, TRAD: + 4 ± 9%) and vastus lateralis (AEL: + 14 ± 14%, TRAD: + 1 ± 10%) and medialis (AEL: + 19 ± 8%, TRAD: + 5 ± 11%) fascicle length.
CONCLUSION


","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Walker', 'Affiliation': 'NeuroMuscular Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä, Room VIV223, 40014, Jyväskylä, Finland. simon.walker@jyu.fi.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Trezise', 'Affiliation': 'School of Medical and Health Sciences, Centre for Exercise and Sports Science Research, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Guy Gregory', 'Initials': 'GG', 'LastName': 'Haff', 'Affiliation': 'School of Medical and Health Sciences, Centre for Exercise and Sports Science Research, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Robert U', 'Initials': 'RU', 'LastName': 'Newton', 'Affiliation': 'School of Medical and Health Sciences, Centre for Exercise and Sports Science Research, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Keijo', 'Initials': 'K', 'LastName': 'Häkkinen', 'Affiliation': 'NeuroMuscular Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä, Room VIV223, 40014, Jyväskylä, Finland.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Blazevich', 'Affiliation': 'School of Medical and Health Sciences, Centre for Exercise and Sports Science Research, Edith Cowan University, Joondalup, WA, Australia.'}]",European journal of applied physiology,['10.1007/s00421-020-04462-x']
1812,32772268,PICSI vs. MACS for abnormal sperm DNA fragmentation ICSI cases: a prospective randomized trial.,"PURPOSE


To know which sperm selection technique, physiological intracytoplasmic sperm injection (PICSI) or magnetic-activated cell sorting (MACS), is better for the selection of sperm with abnormal sperm DNA fragmentation (SDF) in patients undergoing intracytoplasmic sperm injection (ICSI).
METHODS


A prospective randomized trial included 413 ICSI cases with abnormal SDF (> 20.3%) by TUNEL assay. Patients with at least 1 million total progressive motile sperm count were randomized to PICSI or MACS groups on the day of ICSI. PICSI depends on the hyaluronan binding of better SDF sperm where individual sperm was selected, while MACS selects non-apoptotic sperm population using Annexin V magnetic beads. All pre-implantation embryogenic parameters were observed and the main outcome was the ongoing pregnancy rate.
RESULTS


There were no significant differences between patients allocated to PICSI and MACS in the studied parameters including pre-implantation embryological data, implantation, clinical pregnancy, and ongoing pregnancy rates. Meanwhile, sub-analysis according to the female age has shown that female patients with less than 30 years of age in the MACS group had significantly higher good-quality blastocyst, clinical pregnancy, and ongoing pregnancy rates than the PICSI group. However, the higher implantation (p = 0.051), clinical pregnancy (p = 0.078), and ongoing pregnancy (p = 0.097) rates observed in females between 30 and 35 years of age in the PICSI group did not reach significance level.
CONCLUSIONS


PICSI and MACS are efficient techniques for sperm selection in cases with abnormal sperm DNA fragmentation. However, MACS is preferred when the females are younger than 30 years, while PICSI is preferred in older females.
CLINICAL TRIAL REGISTRATION NUMBER


NCT03398317 (retrospectively registered).",2020,"There were no significant differences between patients allocated to PICSI and MACS in the studied parameters including pre-implantation embryological data, implantation, clinical pregnancy, and ongoing pregnancy rates.","['Patients with at least 1 million total progressive motile sperm count', '413 ICSI cases with abnormal SDF (>\u200920.3%) by TUNEL assay', 'patients undergoing intracytoplasmic sperm injection (ICSI', 'female patients with less than 30\xa0years of age in the']","['physiological intracytoplasmic sperm injection (PICSI) or magnetic-activated cell sorting ', 'PICSI or MACS', 'PICSI and MACS', 'PICSI vs. MACS', 'MACS']","['ongoing pregnancy', 'good-quality blastocyst, clinical pregnancy, and ongoing pregnancy rates', 'pre-implantation embryological data, implantation, clinical pregnancy, and ongoing pregnancy rates', 'clinical pregnancy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0577264', 'cui_str': 'Sperm motile'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0376669', 'cui_str': 'DNA Fragmentation'}, {'cui': 'C0600528', 'cui_str': 'In Situ Nick End Labeling'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0007616', 'cui_str': 'Cell Isolation'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1281743', 'cui_str': 'Blastocyst structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",413.0,0.0907136,"There were no significant differences between patients allocated to PICSI and MACS in the studied parameters including pre-implantation embryological data, implantation, clinical pregnancy, and ongoing pregnancy rates.","[{'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Hasanen', 'Affiliation': 'IVF Laboratory, Ganin Fertility Center, Cairo, 11728, Egypt. em.saberh@gmail.com.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Elqusi', 'Affiliation': 'IVF Laboratory, Ganin Fertility Center, Cairo, 11728, Egypt.'}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'ElTanbouly', 'Affiliation': 'IVF Laboratory, Ganin Fertility Center, Cairo, 11728, Egypt.'}, {'ForeName': 'Abd ElGhafar', 'Initials': 'AE', 'LastName': 'Hussin', 'Affiliation': 'IVF Laboratory, Ganin Fertility Center, Cairo, 11728, Egypt.'}, {'ForeName': 'Hanaa', 'Initials': 'H', 'LastName': 'AlKhadr', 'Affiliation': 'IVF Laboratory, Ganin Fertility Center, Cairo, 11728, Egypt.'}, {'ForeName': 'Hosam', 'Initials': 'H', 'LastName': 'Zaki', 'Affiliation': 'IVF Laboratory, Ganin Fertility Center, Cairo, 11728, Egypt.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Henkel', 'Affiliation': 'University of the Western Cape, Cape Town, South Africa.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'American Center for Reproductive Medicine, Cleveland Clinic, Cleveland, OH, USA.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-020-01913-4']
1813,32772319,Does cognitive behavioral education reduce pain and improve joint function in patients after total knee arthroplasty? A randomized controlled trial.,"INTRODUCTION


Cognitive behavioral therapy (CBT) is an effective treatment for reducing the pain of knee osteoarthritis (OA) and improving joint function. However, there are few studies on the effect of CBT on the pain severity after total knee arthroplasty (TKA). This study investigates the effectiveness of a CBT program on pain, knee function, quality of life, and pain catastrophizing in patients after TKA.
METHODS


This was a randomized, parallel-group, controlled trial in which 100 patients with knee osteoarthritis (OA) prepared for TKA were randomly assigned to participate in CBT or usual care group. Evaluation outcomes include Visual Analogue Scale (VAS), Pain Catastrophizing Scale (PCS), Oxford Knee Score (OKS), Knee Range of Motion (ROM), EuroQol Five-Dimensional (EQ-5D), and Hospital for Special Surgery (HSS) Knee Rating Scale before and after surgery.
RESULTS


We found that patients in the CBT group had a lower pain during activity from the fifth day (p = 0.003) to the third month (p = 0.019) after TKA. At the 12th month, the mean VAS score during activity in the CBT and usual care groups decreased from 4.5 to 0.8 and from 4.6 to 0.9, respectively, and there is no significant difference between the two groups. The PCS scores of patients in the CBT group were lower than those in the usual care group at 1st (p = 0.014) and 3rd months (p = 0.027) after surgery. No statistically significantly differences between the two groups in pain during rest, knee ROM, EQ-5D, OKS, and HSS.
CONCLUSIONS


The CBT program was superior to usual care in reducing post-operative pain during activity from the fifth day to the third month and pain catastrophing in the first three months after TKA but has no statistically significantly differences in pain during rest, knee ROM, EQ-5D, OKS, and HSS.
TRIAL REGISTRATION


Current Controlled Trials ChiCTR2000032857, date of registration: May, 14, 2020, retrospectively registered.",2020,"No statistically significantly differences between the two groups in pain during rest, knee ROM, EQ-5D, OKS, and HSS.
","['patients after TKA', '100 patients with knee osteoarthritis (OA) prepared for TKA', 'patients after total knee arthroplasty']","['CBT or usual care group', 'Cognitive behavioral therapy (CBT', 'CBT program', 'CBT']","['PCS scores', 'pain, knee function, quality of life, and pain catastrophizing', 'lower pain during activity', 'pain during rest, knee ROM, EQ-5D, OKS, and HSS', 'Visual Analogue Scale (VAS), Pain Catastrophizing Scale (PCS), Oxford Knee Score (OKS), Knee Range of Motion (ROM), EuroQol Five-Dimensional (EQ-5D), and Hospital for Special Surgery (HSS) Knee Rating Scale', 'joint function', 'pain severity', 'mean VAS score during activity', 'pain of knee osteoarthritis (OA) and improving joint function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0542330', 'cui_str': 'Joint mobilization'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",100.0,0.0581903,"No statistically significantly differences between the two groups in pain during rest, knee ROM, EQ-5D, OKS, and HSS.
","[{'ForeName': 'Jian-Ning', 'Initials': 'JN', 'LastName': 'Sun', 'Affiliation': ""Department of Orthopaedic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huaihai Road, Xuzhou, 221002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopaedic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huaihai Road, Xuzhou, 221002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huaihai Road, Xuzhou, 221002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huaihai Road, Xuzhou, 221002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': ""Department of Orthopaedic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huaihai Road, Xuzhou, 221002, Jiangsu, People's Republic of China. xzfs0561@163.com.""}, {'ForeName': 'Xiang-Yang', 'Initials': 'XY', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopaedic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huaihai Road, Xuzhou, 221002, Jiangsu, People's Republic of China. 781733181@qq.com.""}]",International orthopaedics,['10.1007/s00264-020-04767-8']
1814,32772474,A Single institution's randomized double-armed prospective study of lumpectomy margins with adjunctive use of the MarginProbe in nonpalpable breast cancers.,"Breast conservation surgery (BCS) aims to excise all cancerous tissue while minimizing the amount of healthy breast tissue removed. Up to 30% of patients undergoing BCS require a second operation for re-excision to obtain negative margins. Previous studies reported a lower re-excision rate with intraoperative use of the MarginProbe device (Dune Medical Devices). This device utilizes radiofrequency spectroscopy to detect differences between cancerous and normal tissue. From July 2009 to January 2010, our institution enrolled 46 patients electing for BCS in a prospective double-arm randomized controlled trial and had a significantly lower re-excision rate than that reported in the multicenter trial. Intraoperatively, after performing conventional lumpectomy with excision of any additional shavings deemed necessary based on palpation and visual inspection alone, patients were then randomized. In the device arm, the surgeon used the MarginProbe to interrogate the lumpectomy specimen, taking additional shavings from the cavity surfaces corresponding to the parts of the specimen read as positive by the device. In the control arm, only standard intraoperative assessments were performed. All specimens were evaluated by pathologists who were blinded to the study arm. In this population, 72% had invasive ductal carcinoma (IDC), 20% had ductal carcinoma in situ (DCIS), and 8% had invasive lobular carcinoma (ILC). Average age was 64 years old. The average size of the specimen was 5.6 cm, the average volume was 37.8 cm 3  , and the average weight was 32.7 g. The mean size of DCIS was 1.4 cm. For invasive specimens, 32 were T1 and 7 were T2. Prior to randomization, 43 patients were thought to have positive or close margins and therefore underwent additional shavings. Twenty-three patients were randomized to the device arm and 23 to the control arm. In the device arm, 14 (60%) patients had IDC, 7 (30%) had DCIS, and 2 (8%) had ILC, vs the control arm where 19 (82%) patients had IDC, 2 (8%) had DCIS, and 2 (8%) had ILC. Eight (35%) patients in the control group vs 1 (4%) in the device group underwent re-excision for margin involvement (P < .05). The use of the MarginProbe device at our institution significantly improved the ability of our surgeons to obtain clear margins during initial BCS. Our results show a lower re-excision rate (4%) than those published in the multicenter trial (19.8%). We postulate that in the face of more patients having DCIS in our device group (30%), our surgeons responded by taking thicker shavings when the MarginProbe device reported margin involvement during the initial lumpectomy, resulting in greater success achieving clear final margins on the shaved tissue and a significantly lower re-excision rate than previously reported with the MarginProbe device.",2020,Previous studies reported a lower re-excision rate with intraoperative use of the MarginProbe device (Dune Medical Devices).,"['nonpalpable breast cancers', '43 patients were thought to have positive or close margins and therefore underwent additional shavings', 'From July 2009 to January 2010, our institution enrolled 46 patients electing for', 'In this population, 72% had invasive ductal carcinoma (IDC), 20% had ductal carcinoma in situ (DCIS), and 8% had invasive lobular carcinoma (ILC', 'Average age was 64\xa0years old']","['MarginProbe', 'Breast conservation surgery (BCS', 'BCS', 'lumpectomy margins']","['re-excision rate', 'average size of the specimen', 'ILC', 'average weight', 'mean size of DCIS']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1269795', 'cui_str': 'Margin closest to tumor'}, {'cui': 'C0518505', 'cui_str': 'Does shave'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1134719', 'cui_str': 'Infiltrating ductular carcinoma'}, {'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0206692', 'cui_str': 'Lobular carcinoma'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0851238', 'cui_str': 'Lumpectomy of breast'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}]","[{'cui': 'C0184913', 'cui_str': 'Reexcision'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0206692', 'cui_str': 'Lobular carcinoma'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}]",46.0,0.0705343,Previous studies reported a lower re-excision rate with intraoperative use of the MarginProbe device (Dune Medical Devices).,"[{'ForeName': 'Rula C', 'Initials': 'RC', 'LastName': 'Geha', 'Affiliation': 'Division of Life Sciences, Mac Andrews and Forbes, Inc, New York, New York, USA.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Taback', 'Affiliation': 'Department of Surgery, New York Presbyterian Hospital, Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cadena', 'Affiliation': 'Dune Medical Devices, Alpharetta, Georgia, USA.'}, {'ForeName': 'Billie', 'Initials': 'B', 'LastName': 'Borden', 'Affiliation': 'Department of Surgery, Northwell Health, Lenox Hill Hospital, New York, New York, USA.'}, {'ForeName': 'Sheldon', 'Initials': 'S', 'LastName': 'Feldman', 'Affiliation': 'Department of Surgery, Montefiore Medical Center, Montefiore Einstein Center for Cancer Care, Bronx, New York, USA.'}]",The breast journal,['10.1111/tbj.14004']
1815,32772491,East Asian Diet-Mimicking Diet Plan Based on the Mediterranean Diet and the DASH Diet in Adults with Type 2 Diabetes: A Randomized Controlled Trial.,"BACKGROUND/OBJECTIVES


Using an investigational diet plan based on the Mediterranean diet and the Dietary Approaches to Stop Hypertension diet comprised of substitute ingredients that mimic the average East Asian diet, this study assessed glycemic benefits in comparison to a food exchange system (FES)-based diet in established type 2 diabetes.
SUBJECTS/METHODS


This was a 12-week, open-label randomized clinical trial conducted among 60 Korean adults with type 2 diabetes having a median body mass index of 23.5 kg/m 2  . Glycemic benefits in the investigational diet (group A) were compared to those obtained with a FES-based diet, either in the form of ready meals provided to participants (group B) or not (group C). The primary endpoint was changes in HbA1c from baseline to week 12.
RESULTS


Changes in HbA1c (%) from baseline to week 12 were -0.97 ± 0.97 in group A (vs. group B, P = 0.085 in the full analysis set [FAS] and P = 0.028 in the per-protocol set [PPS]; vs. group C, P = 0.030 in FAS and P = 0.020 in PPS), -0.51 ± 0.65 in group B (vs. group C, P > 0.05 in FAS and PPS), and -0.36 ± 0.74 in group C. Decreases from baseline in body mass index, waist circumference, and blood pressure were greater in group A than in group C.
CONCLUSION


With provision of ready meals, the glycemic benefits of the investigational diet plan were demonstrable over a self-prepared FES-based diet in Korean adults with established type 2 diabetes.",2020,"RESULTS


Changes in HbA1c (%) from baseline to week 12 were -0.97 ± 0.97 in group A (vs. group B, P = 0.085 in the full analysis set [FAS] and P = 0.028 in the per-protocol set [PPS]; vs. group C, P = 0.030 in FAS and P = 0.020 in PPS), -0.51 ± 0.65 in group B (vs. group C, P > 0.05 in FAS and PPS), and -0.36 ± 0.74 in group C. Decreases from baseline in body mass index, waist circumference, and blood pressure were greater in group A than in group C.
CONCLUSION


With provision of ready meals, the glycemic benefits of the investigational diet plan were demonstrable over a self-prepared FES-based diet in Korean adults with established type 2 diabetes.","['Adults with Type 2 Diabetes', 'Korean adults with established type 2 diabetes', '60 Korean adults with type 2 diabetes having a median body mass index of 23.5 kg/m 2  ']","['food exchange system (FES)-based diet', 'Mediterranean Diet and the DASH Diet']","['body mass index, waist circumference, and blood pressure', 'Glycemic benefits', 'changes in HbA1c']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",60.0,0.0399272,"RESULTS


Changes in HbA1c (%) from baseline to week 12 were -0.97 ± 0.97 in group A (vs. group B, P = 0.085 in the full analysis set [FAS] and P = 0.028 in the per-protocol set [PPS]; vs. group C, P = 0.030 in FAS and P = 0.020 in PPS), -0.51 ± 0.65 in group B (vs. group C, P > 0.05 in FAS and PPS), and -0.36 ± 0.74 in group C. Decreases from baseline in body mass index, waist circumference, and blood pressure were greater in group A than in group C.
CONCLUSION


With provision of ready meals, the glycemic benefits of the investigational diet plan were demonstrable over a self-prepared FES-based diet in Korean adults with established type 2 diabetes.","[{'ForeName': 'Sang-Man', 'Initials': 'SM', 'LastName': 'Jin', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jiyeon', 'Initials': 'J', 'LastName': 'Ahn', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Hanyang University College of Medicine, Myongji Hospital, Goyang, Korea.'}, {'ForeName': 'Jiyun', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kyu Yeon', 'Initials': 'KY', 'LastName': 'Hur', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Hyeon', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Moon-Kyu', 'Initials': 'MK', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Gumi Hospital, Soonchunhyang University School of Medicine, Gumi, Korea.'}]",Journal of diabetes investigation,['10.1111/jdi.13384']
1816,32772509,Effects of a Web-Based Educational Support Intervention on Total Exercise and Cardiovascular Risk Markers in Adults With Coronary Heart Disease.,"BACKGROUND


eHealth educational programs have proven to be an effective means for health promotion, yet limited studies have been conducted for coronary heart disease (CHD) patients to improve their total physical exercise, self-efficacy for exercise, and cardiovascular risk factor profile.
METHOD


A prospective randomized controlled trial (RCT) was conducted in two cardiac clinics in Hong Kong. Four hundred thirty-eight eligible CHD clients were randomly assigned to either the control or the intervention group. All of the participants received standard care, which consisted of regular medical and nursing care in the cardiac clinic. The intervention group received an additional web-based educational support intervention (eHES), which consisted of a 20-minute individual educational session on the use of the eHES web link. The eHES web link contains a health information platform related to CHD care and an individual member area with records of health measures and physical exercise data for six months. Data were collected at baseline, at three-month and six-month intervals at the cardiac clinic. The primary outcome was the total amount of physical exercise, measured by the Godin-Shephard Leisure-Time Physical Activity Questionnaire. The secondary outcomes were self-efficacy for exercise and cardiovascular disease (CVD) risk markers (body weight, blood pressure, lipid profile). The data were analyzed using a generalized estimating equations model.
RESULTS


The intervention group reported a statistically higher amount of physical exercise and a higher HDL-C at 3 and 6 months, respectively. There were no statistical differences between the groups in self-efficacy for exercise and other CVD risk markers.
LINKING EVIDENCE TO ACTION


The study demonstrated the effectiveness of the eHES in meeting the challenge of boosting the amount of physical exercise and increase HDL-C among CHD patients who engaged for over three months. The results provide insight for eHealth development to support and promote exercise among CHD patients in the community.",2020,"The intervention group reported a statistically higher amount of physical exercise and a higher HDL-C at 3 and 6 months, respectively.","['CHD patients who engaged for over three months', 'Four hundred thirty-eight eligible CHD clients', 'two cardiac clinics in Hong Kong', 'Adults With Coronary Heart Disease']","['Web-Based Educational Support Intervention', 'additional web-based educational support intervention (eHES']","['amount of physical exercise and a higher HDL-C', 'total amount of physical exercise, measured by the Godin-Shephard Leisure-Time Physical Activity Questionnaire', 'Total Exercise and Cardiovascular Risk Markers', 'self-efficacy for exercise and cardiovascular disease (CVD) risk markers (body weight, blood pressure, lipid profile']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",438.0,0.0338477,"The intervention group reported a statistically higher amount of physical exercise and a higher HDL-C at 3 and 6 months, respectively.","[{'ForeName': 'Eliza Mi-Ling', 'Initials': 'EM', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}, {'ForeName': 'Doris Y P', 'Initials': 'DYP', 'LastName': 'Leung', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}, {'ForeName': 'Sek-Ying', 'Initials': 'SY', 'LastName': 'Chair', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Janet W H', 'Initials': 'JWH', 'LastName': 'Sit', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong SAR, China.'}]",Worldviews on evidence-based nursing,['10.1111/wvn.12456']
1817,32770969,"""Oh-oh, the others are standing up... I better do the same"". Mixed-method evaluation of the implementation process of 'Take a Stand!' - a cluster randomized controlled trial of a multicomponent intervention to reduce sitting time among office workers.","BACKGROUND


Multicomponent workplace-based interventions aimed at reducing sitting time among office workers are becoming increasingly popular. 'Take a Stand!' was such an intervention, reducing sitting time by 71 min after 1 month and 48 min after 3 months. However, it is unclear how the implementation process of 'Take a Stand!' affected these results. The present study explored how individual factors and organizational context influenced implementation and effect in 'Take a Stand!'
METHODS


This was a mixed-methods study, combining data from interviews, questionnaires and accelerometers. Directed content analysis was used for analysing interviews with participants, ambassadors and managers from the 10 intervention offices in the 'Take a Stand!'
STUDY


Categories for analysis were taken from Framework for Evaluating Organizational-level Interventions. Interview data were combined with questionnaire and activity data, and multilevel analysis was undertaken to assess how changes in sitting time varied depending on the assessed factors. In addition, interview data were used to underpin results from the multilevel analysis.
RESULTS


Concurrent institutional changes were found to be a barrier for the intervention by ambassadors, while participants and managers did not find it to be an issue. Management support was consistently highlighted as very important. Participants evaluated ambassadors as being generally adequately active but also, that the role had a greater potential. The motivational and social aspects of the intervention were considered important for the effect. This was supported by regression analyses, which showed that a strong desire to change sitting time habits, strong motivation towards the project, and a high sense of collective engagement were associated to less sitting time at 3 months of about 30 min/8 h working day compared to participants with low scores. Influence from other participants (e.g. seeing others raise their tables) and the use of humour were continuously highlighted by participants as positive for implementation. Finally, the intervention was found to influence the social climate at the workplace positively.
CONCLUSION


Individual motivation was related to the sitting time effect of 'Take a Stand!', but the organizational culture was relevant both to the implementation and effect within the office community. The organizational culture included among others to ensure general participation, to uphold management and peer-support, and maintain a positive environment during the intervention period.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT01996176 . Prospectively registered 21 November 2013.",2020,"Individual motivation was related to the sitting time effect of 'Take a Stand!', but the organizational culture was relevant both to the implementation and effect within the office community.","['office workers', 'Prospectively registered 21 November 2013', ""interviews with participants, ambassadors and managers from the 10 intervention offices in the 'Take a Stand""]",['multicomponent intervention'],"['sitting time', 'social climate']","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0335141', 'cui_str': 'Manager'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008946', 'cui_str': 'Climate'}]",,0.0489399,"Individual motivation was related to the sitting time effect of 'Take a Stand!', but the organizational culture was relevant both to the implementation and effect within the office community.","[{'ForeName': 'Ida H', 'Initials': 'IH', 'LastName': 'Danquah', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Studiestræde 6, 1455, Copenhagen, Denmark. idah@niph.dk.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Kloster', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Studiestræde 6, 1455, Copenhagen, Denmark.'}, {'ForeName': 'Janne S', 'Initials': 'JS', 'LastName': 'Tolstrup', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Studiestræde 6, 1455, Copenhagen, Denmark.'}]",BMC public health,['10.1186/s12889-020-09226-y']
1818,32770972,Protocol of the VICTORIA study: personalized vitamin D supplementation for reducing or preventing fatigue and enhancing quality of life of patients with colorectal tumor - randomized intervention trial.,"BACKGROUND


Cancer-related fatigue represents one major cause of reduced quality of life in cancer patients and can seriously affect the physical, emotional, and cognitive functioning impeding coping with the disease. Options for effective treatment of cancer-related fatigue are limited, consisting only of non-pharmacologic interventions like physical activity, psychosocial, and mind-body interventions. Recent evidence suggests that vitamin D 3  supplementation might alleviate cancer-related fatigue. However, confirmation in a randomized controlled trial is needed.
METHODS


In this multicenter, randomized, double-blind, placebo-controlled trial, 456 colorectal cancer (CRC) patients aged 18 years and older are being recruited in three German rehabilitation clinics. Study inclusion requires hospitalization of at least 3 weeks at such a clinic, a diagnosis of non-metastatic CRC (stage I-III), surgical removal of the tumor within the past 9 months, and season-adapted vitamin D insufficiency or deficiency. Eligible patients are randomly assigned to a personalized regimen of vitamin D 3  or placebo for 12 weeks. In the intervention group, a loading dose of 20,000 or 40,000 IU vitamin D 3  will be administered daily during the first 11 days, followed by a maintenance dose of 2000 IU daily. Patients will complete questionnaires for secondary outcomes (fatigue subdomains, quality of life and subdomains, depression, functional well-being, and infection frequency). Blood and urine samples will be collected for analyses of safety parameters (hypervitaminosis D, hypercalcemia, hypercalciuria, and renal impairment) and efficacy biomarkers (25-hydroxyvitamin D, HbA 1c , white blood cell count, leukocyte subtype counts, serum C-reactive protein, uric acid, creatinine, triglycerides, total, low- and high-density lipoprotein cholesterol).
DISCUSSION


This trial tests whether a personalized vitamin D 3  dosing regimen reduces or prevents fatigue among non-metastatic CRC patients by treating the underlying vitamin D deficiency/insufficiency. If efficacy can be confirmed, personalized vitamin D 3  supplementation could be used as a tertiary prevention measure in addition to non-pharmacological treatments of cancer-related fatigue in CRC patients. We expect to detect an effect of vitamin D 3  supplementation on secondary outcomes like quality of life, depression, functional well-being, infections, inflammatory biomarkers, diabetes mellitus, and dyslipidemia.
TRIAL REGISTRATION


European Clinical Trials Database: EudraCT-No: 2019-000502-30, January 21, 2019; German Clinical Trials Register (DRKS): DRKS00019907 , April 30, 2019.",2020,"We expect to detect an effect of vitamin D 3  supplementation on secondary outcomes like quality of life, depression, functional well-being, infections, inflammatory biomarkers, diabetes mellitus, and dyslipidemia.
","['cancer patients', 'patients with colorectal tumor -\xa0randomized intervention trial', 'Study inclusion requires hospitalization of at least 3 weeks at such a clinic, a diagnosis of non-metastatic CRC (stage I-III), surgical removal of the tumor within the past 9 months, and season-adapted vitamin D insufficiency or deficiency', 'non-metastatic CRC patients by treating the underlying vitamin D deficiency/insufficiency', '456 colorectal cancer (CRC) patients aged 18\u2009years and older are being recruited in three German rehabilitation clinics', 'Eligible patients']","['vitamin D 3  or placebo', 'vitamin D 3  supplementation', 'personalized vitamin D', 'vitamin D supplementation', 'placebo']","['secondary outcomes like quality of life, depression, functional well-being, infections, inflammatory biomarkers, diabetes mellitus, and dyslipidemia', 'secondary outcomes (fatigue subdomains, quality of life and subdomains, depression, functional well-being, and infection frequency', 'fatigue and enhancing quality of life', 'safety parameters (hypervitaminosis D, hypercalcemia, hypercalciuria, and renal impairment) and efficacy biomarkers (25-hydroxyvitamin D, HbA 1c , white blood cell count, leukocyte subtype counts, serum C-reactive protein, uric acid, creatinine, triglycerides, total, low- and high-density lipoprotein cholesterol']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009404', 'cui_str': 'Neoplasm of large intestine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C3839785', 'cui_str': 'Rehabilitation clinic'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0242154', 'cui_str': 'Poisoning by vitamin D'}, {'cui': 'C0020437', 'cui_str': 'Hypercalcemia'}, {'cui': 'C0020438', 'cui_str': 'Hypercalciuria'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}]",456.0,0.362555,"We expect to detect an effect of vitamin D 3  supplementation on secondary outcomes like quality of life, depression, functional well-being, infections, inflammatory biomarkers, diabetes mellitus, and dyslipidemia.
","[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Schöttker', 'Affiliation': 'Division of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), Im Neuenheimer Feld 581, 69120, Heidelberg, Germany. b.schoettker@dkfz.de.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Kuznia', 'Affiliation': 'Division of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), Im Neuenheimer Feld 581, 69120, Heidelberg, Germany.'}, {'ForeName': 'Dana Clarissa', 'Initials': 'DC', 'LastName': 'Laetsch', 'Affiliation': 'Division of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), Im Neuenheimer Feld 581, 69120, Heidelberg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Czock', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University Hospital Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Kopp-Schneider', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center (DKFZ), Im Neuenheimer Feld 581, 69120, Heidelberg, Germany.'}, {'ForeName': 'Reiner', 'Initials': 'R', 'LastName': 'Caspari', 'Affiliation': 'Rehabilitation Clinic Niederrhein, Hochstraße 13-19, 53474, Bad Neuenahr-Ahrweiler, Germany.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Brenner', 'Affiliation': 'Division of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), Im Neuenheimer Feld 581, 69120, Heidelberg, Germany.'}]",BMC cancer,['10.1186/s12885-020-07219-z']
1819,32770983,"BAck iN the Game (BANG) - a smartphone application to help athletes return to sport following anterior cruciate ligament reconstruction: protocol for a multi-centre, randomised controlled trial.","BACKGROUND


Sustaining injury is a common consequence of playing sport. At least one in every three recreational athletes with anterior cruciate ligament (ACL) reconstruction do not return to their preinjury sport following treatment. Psychological factors including confidence and fear of new injury exert large effects on returning to sport. The primary aim of this trial is to test whether a custom smartphone application delivering cognitive-behavioural therapy is effective for improving the number of people who return to their preinjury sport and level following ACL reconstruction.
METHODS


Participants scheduled for primary ACL reconstruction are recruited prior to surgery from one of six trial sites in Sweden. We aim to recruit 222 participants (111 in each group) for the BANG trial. Participants are randomly allocated to receive either usual rehabilitation care alone or usual rehabilitation care plus the Back in the Game smartphone application intervention. Back in the Game is a 24-week Internet-delivered programme, based on cognitive-behavioural therapy. The primary outcome is return to the preinjury sport and level at 12 months follow-up. The secondary outcomes assess physical activity participation, new knee injuries, psychological factors, quality of life and physical function. Physical activity participation and new injuries are self-reported every two weeks for 12 months, then every 4 weeks to 24 months follow-up. Psychological readiness to return to sport, knee self-efficacy, motivation to participate in leisure time physical activity, knee-related quality of life, and self-reported knee function are also assessed at 3, 6, 9, 12 and 24 months after surgery. A clinical assessment of strength, knee range of motion, effusion and hopping performance is completed by a blinded assessor at 12 months to assess physical function.
DISCUSSION


This protocol outlines how we plan to assess the efficacy of a custom smartphone application, delivering cognitive-behavioural therapy to address fear, confidence and recovery expectations, for improving return to sport following serious sports-related musculoskeletal injury. The BANG trial employs a pragmatic design to best reflect the reality of, and inform, clinical practice.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03959215 . Registered 22 May 2019.",2020,Participants are randomly allocated to receive either usual rehabilitation care alone or usual rehabilitation care plus the Back in the Game smartphone application intervention.,"['222 participants (111 in each group) for the BANG trial', 'people who return to their preinjury sport and level following ACL reconstruction', 'Participants scheduled for primary ACL reconstruction are recruited prior to surgery from one of six\xa0trial sites in Sweden']","['usual rehabilitation care alone or usual rehabilitation care plus the Back in the Game smartphone application intervention', 'anterior cruciate ligament (ACL) reconstruction', 'custom smartphone application, delivering cognitive-behavioural therapy', 'custom smartphone application delivering cognitive-behavioural therapy', 'BAck iN the Game (BANG) - a smartphone application']","['strength, knee range of motion, effusion and hopping performance', 'physical activity participation, new knee injuries, psychological factors, quality of life and physical function', 'return to the preinjury sport and level', 'Psychological readiness to return to sport, knee self-efficacy, motivation to participate in leisure time physical activity, knee-related quality of life, and self-reported knee function']","[{'cui': 'C0303403', 'cui_str': 'Indium-111'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0302363', 'cui_str': 'Infection due to Brucella abortus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C0013687', 'cui_str': 'Effusion'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C0033898', 'cui_str': 'Factors, Psychological'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",,0.0973137,Participants are randomly allocated to receive either usual rehabilitation care alone or usual rehabilitation care plus the Back in the Game smartphone application intervention.,"[{'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Ardern', 'Affiliation': 'Division of Physiotherapy, Karolinska Institute, Stockholm, Sweden. clare.ardern@liu.se.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Kvist', 'Affiliation': 'Division of Physiotherapy, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03508-7']
1820,32771002,Design and study protocol for a cluster randomized trial of a multi-faceted implementation strategy to increase the uptake of the USPSTF hypertension screening recommendations: the EMBRACE study.,"BACKGROUND


The US Preventive Services Task Force (USPSTF) recommends out-of-office blood pressure (BP) testing to exclude white coat hypertension prior to hypertension diagnosis. Despite improved availability and coverage of home and 24-h ambulatory BP monitoring (HBPM, ABPM), both are infrequently used to confirm diagnoses. We used the Behavior Change Wheel (BCW) framework, a multi-step process for mapping barriers to theory-informed behavior change techniques, to develop a multi-component implementation strategy for increasing out-of-office BP testing for hypertension diagnosis. Informed by geographically diverse provider focus groups (n = 63) exploring barriers to out-of-office testing and key informant interviews (n = 12), a multi-disciplinary team (medicine, psychology, nursing) used rigorous mixed methods to develop, refine, locally adapt, and finalize intervention components. The purpose of this report is to describe the protocol of the Effects of a Multi-faceted intervention on Blood pRessure Actions in the primary Care Environment (EMBRACE) trial, a cluster randomized control trial evaluating whether a theory-informed multi-component strategy increased out-of-office testing for hypertension diagnosis.
METHODS/DESIGN


The EMBRACE Trial patient sample will include all adults ≥ 18 years of age with a newly elevated office BP (≥ 140/90 mmHg) at a scheduled visit with a primary care provider from a study clinic. All providers with scheduled visits with adult primary care patients at enrolled ACN primary care clinics were included. We determined that the most feasible, effective implementation strategy would include delivering education about out-of-office testing, demonstration/instruction on how to perform out-of-office HBPM and ABPM testing, feedback on completion rates of out-of-office testing, environmental prompts/cues via computerized clinical decision support (CDS) tool, and a culturally tailored, locally accessible ABPM testing service. We are currently comparing the effect of this locally adapted multi-component strategy with usual care on the change in the proportion of eligible patients who complete out-of-office BP testing in a 1:1 cluster randomized trial across 8 socioeconomically diverse clinics.
CONCLUSIONS


The EMBRACE trial is the first trial to test an implementation strategy for improving out-of-office testing for hypertension diagnosis. It will elucidate the degree to which targeting provider behavior via education, reminders, and decision support in addition to providing an ABPM testing service will improve referral to and completion of ABPM and HBPMs.
TRIAL REGISTRATION


Clinicaltrials.gov , NCT03480217 , Registered on 29 March 2018.",2020,The EMBRACE trial is the first trial to test an implementation strategy for improving out-of-office testing for hypertension diagnosis.,"['eligible patients who complete out-of-office BP testing in a 1:1 cluster randomized trial across 8 socioeconomically diverse clinics', 'All providers with scheduled visits with adult primary care patients at enrolled ACN primary care clinics were included', 'all adults ≥ 18 years of age with a newly elevated office BP (≥ 140/90 mmHg) at a scheduled visit with a primary care provider from a study clinic']","['Multi-faceted intervention', 'multi-disciplinary team (medicine, psychology, nursing) used rigorous mixed methods to develop, refine, locally adapt, and finalize intervention components']","['Blood pRessure Actions', 'availability and coverage of home and 24-h ambulatory BP monitoring (HBPM, ABPM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0085114', 'cui_str': 'Genes, nf2'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0649948', 'cui_str': '4-(2-(4-hydroxybenzyl)-phenoxy)-N-methylbutylamine'}]",,0.0724221,The EMBRACE trial is the first trial to test an implementation strategy for improving out-of-office testing for hypertension diagnosis.,"[{'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Moise', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center, 622 W. 168th Street, New York, NY, 10032, USA. nm2562@cumc.columbia.edu.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Phillips', 'Affiliation': 'Division of General Internal Medicine, Weill Cornell Medicine, 1320 York Avenue, New York, NY, 10021, USA.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Carter', 'Affiliation': 'Columbia University School of Nursing, Columbia University Irving Medical Center, 560 West 168th Street, New York, NY, 10032, USA.'}, {'ForeName': 'Carmela', 'Initials': 'C', 'LastName': 'Alcantara', 'Affiliation': 'Columbia University School of Social Work, 1255 Amsterdam Avenue, New York, NY, 10027, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Julian', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center, 622 W. 168th Street, New York, NY, 10032, USA.'}, {'ForeName': 'Anusorn', 'Initials': 'A', 'LastName': 'Thanataveerat', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center, 622 W. 168th Street, New York, NY, 10032, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Schwartz', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center, 622 W. 168th Street, New York, NY, 10032, USA.'}, {'ForeName': 'Siqin', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center, 622 W. 168th Street, New York, NY, 10032, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Duran', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center, 622 W. 168th Street, New York, NY, 10032, USA.'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Shimbo', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center, 622 W. 168th Street, New York, NY, 10032, USA.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Kronish', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center, 622 W. 168th Street, New York, NY, 10032, USA.'}]",Implementation science : IS,['10.1186/s13012-020-01017-8']
1821,32771032,"Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment (PROTECT) of Hydroxychloroquine, Oseltamivir and Azithromycin to treat newly diagnosed patients with COVID-19 infection who have no comorbidities like diabetes mellitus: A structured summary of a study protocol for a randomized controlled trial.","OBJECTIVES


To evaluate the effectiveness of Hydroxychloroquine Phosphate/Sulfate (200 mg orally 8 hourly thrice a day for 5 days), versus oseltamivir (75 mg orally twice a day for 5 days), and versus Azithromycin (500 mg orally daily on day 1, followed by 250 mg orally twice a day on days 2-5) alone and in combination (in all seven groups), in clearing the coronavirus (COVID-19) nucleic acid from throat and nasal swab and in bringing about clinical improvement on day 7 of follow-up (primary outcomes).
TRIAL DESIGN


An adaptive design, set within a comprehensive cohort study, to permit flexibility in this fast-changing clinical and public health scenario. The randomized study will be a multicenter, multiarm, multistage, randomized controlled trial with a parallel design. An observation only cohort will emerge from those not consenting to randomization.
PARTICIPANTS


Eligible will be newly diagnosed patients, either hospitalized or in self-isolation, without any comorbidities or with controlled chronic medical conditions like diabetes mellitus and hypertension. Participants of any gender or age group having tested positive for COVID-19 on Real-Time qRT-PCR (Quantitative Reverse Transcription PCR) will be invited to take part in study at twelve centers across eight cities in Pakistan. Those pregnant or lactating, severely dyspneic or with respiratory distress, already undergoing treatment, and with serious comorbidities like liver or kidney failure will be excluded.
INTERVENTION AND COMPARATOR


There will be a total of seven comparator groups: Each drug (Hydroxychloroquine Phosphate/Sulfate, Oseltamivir and Azithromycin) given as monotherapy (three groups); combinations of each of two drugs (three groups); and a final group on triple drug regimen.
MAIN OUTCOMES


The laboratory-based primary outcome will be turning the test negative for COVID-19 on qRT-PCR on day 7 of follow-up. The clinical primary outcome will be improvement from baseline of two points on a seven-category ordinal scale of clinical status on day 7 of follow-up.
RANDOMIZATION


Participants will be randomized, maintaining concealment of allocation sequence, using a computer-generated random number list of variable block size into multiple intervention groups in the allocation ratio of 1:1 for all groups.
BLINDING (MASKING)


This is an open label study, neither physician nor participants will be blinded.
NUMBERS TO BE RANDOMIZED (SAMPLE SIZE)


This is an adaptive design and parameters for formal sample size calculation in a new disease of a previously unknown virus are not available. Thus, the final sample size will be subjected to periodic reviews at each stage of adaptive design and subsequent advice of National Data Safety & Management Board (NDSMB) notified by Drug Regulatory Authority of Pakistan.
TRIAL STATUS


Protocol Version 1.7 dated July 5, 2020. By July 03, 2020, the trial had recruited a total of about 470 participants across 12 centers after approval from the National Bioethics Committee and Drug Regulatory Authority of Pakistan. Recruitment started on April 20, 2020. The recruitment is expected to continue for at least three months subject to review by the National Data Safety and Management Board (NDSMB) notified by Drug Regulatory Authority of Pakistan.
TRIAL REGISTRATION


Prospectively registered on 8 April 2020 at clinicaltrials.gov ID: NCT04338698 The full protocol is attached as an additional file, accessible from the Trials website (Additional file1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file2).",2020,Participants of any gender or age group having tested positive for COVID-19 on Real-Time qRT-PCR (Quantitative Reverse Transcription PCR) will be invited to take part in study at twelve centers across eight cities in Pakistan.,"['Those pregnant or lactating, severely dyspneic or with respiratory distress, already undergoing treatment, and with serious comorbidities like liver or kidney failure will be excluded', 'newly diagnosed patients with COVID-19 infection who have no comorbidities like diabetes mellitus', '8 April 2020 at clinicaltrials.gov ID', 'By July 03, 2020, the trial had recruited a total of about 470 participants across 12 centers after approval from the National Bioethics Committee and Drug Regulatory Authority of Pakistan', 'Eligible will be newly diagnosed patients, either hospitalized or in self-isolation, without any comorbidities or with controlled chronic medical conditions like diabetes mellitus and hypertension', 'Participants of any gender or age group having tested positive for COVID-19 on Real-Time qRT-PCR (Quantitative Reverse Transcription PCR) will be invited to take part in study at twelve centers across eight cities in Pakistan', 'Protocol Version 1.7 dated July 5, 2020']","['Hydroxychloroquine Phosphate/Sulfate', 'oseltamivir', 'Azithromycin', 'Hydroxychloroquine, Oseltamivir and Azithromycin', 'drug (Hydroxychloroquine Phosphate/Sulfate, Oseltamivir and Azithromycin']",['seven-category ordinal scale of clinical status on day 7 of follow-up'],"[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0005489', 'cui_str': 'Bioethics'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0035380', 'cui_str': 'Transcription, Reverse'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0011008', 'cui_str': 'Date'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",,0.220653,Participants of any gender or age group having tested positive for COVID-19 on Real-Time qRT-PCR (Quantitative Reverse Transcription PCR) will be invited to take part in study at twelve centers across eight cities in Pakistan.,"[{'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Akram', 'Affiliation': 'Vice Chancellor/Professor of Internal Medicine, University of Health Sciences, Lahore, Pakistan.'}, {'ForeName': 'Shehnoor', 'Initials': 'S', 'LastName': 'Azhar', 'Affiliation': 'Assistant Professor Public Health, University of Health Sciences, Lahore, Pakistan. shehnoor.azhar@gmail.com.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Shahzad', 'Affiliation': 'Professor of Pharmacology, University of Health Sciences, Lahore, Pakistan.'}, {'ForeName': 'Waqas', 'Initials': 'W', 'LastName': 'Latif', 'Affiliation': 'Data Analyst at University of Health Sciences, Lahore, Pakistan.'}, {'ForeName': 'Khalid Saeed', 'Initials': 'KS', 'LastName': 'Khan', 'Affiliation': 'Distinguished Investigator at Department of Preventive Medicine and Public Health, University of Granada, Granada, Spain.'}]",Trials,['10.1186/s13063-020-04616-4']
1822,32771034,"Nigella sativa supplementation to treat symptomatic mild COVID-19: A structured summary of a protocol for a randomised, controlled, clinical trial.","OBJECTIVES


To investigate the potential efficacy of Nigella sativa (NS) oil supplementation on the outcomes of patients with mild Coronavirus Disease 2019 (COVID-19).
TRIAL DESIGN


Prospective, two-arm, parallel-group, randomised (1:1 allocation ratio), open-label, controlled, exploratory phase II clinical trial of oral NS oil in patients with mild COVID-19.
PARTICIPANTS


Inclusion Criteria: - Patients with mild COVID19 (defined as upper respiratory tract infection symptoms in the absence of clinical or radiological signs of pneumonia). - Adult (18 - 65 years old). - Written informed consent by the patient (or legally authorized representative) prior to initiation of any study procedures. - All patients should understand and agree to comply with planned study procedures. - Polymerase chain reaction (PCR)-confirmed infection with Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) from throat swab.
EXCLUSION CRITERIA


- Patients with pneumonia or severe illness requiring admission to intensive care unit. - Severe chronic kidney disease (i.e. estimated glomerular filtration rate [eGFR] < 30 mL / min ) or end stage renal disease requiring dialysis - Severe chronic liver disease (Alanine transaminase [AlT] or Aspartate transaminase [AST] > 5 times the upper limit of normal). - Pregnancy or breast feeding. - Anticipated transfer within 72 hours to another hospital that is not a study site. - Allergy to the study medication The trial is currently conducted on patients recruited from King Abdulaziz University Hospital, Jeddah, Saudi Arabia.
INTERVENTION AND COMPARATOR


Intervention group: Nigella sativa oil (MARNYS® Cuminmar) 500 mg softgel capsules, one capsule orally twice daily for 10 days plus standard of care treatment (antipyretic, antitussive). Comparator group: standard of care treatment.
MAIN OUTCOMES


Proportion of patients who clinically recovered (defined as 3 days of no symptoms) within 14 days after randomisation.
RANDOMISATION


Patients will be randomly assigned to treatment or control groups in a 1:1 ratio using a computer-generated randomization scheme (Random permuted blocks of 10) developed using the web-based program: http://www.randomization.com .
BLINDING (MASKING)


No blinding.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


Up to 200 eligible patients will be randomly assigned to either treatment or control groups.
TRIAL STATUS


Protocol version 1, as of July 14, 2020. Recruitment was started on May 21, 2020. The intended completion date is December 31, 2020.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04401202 . Date of trial registration: May 26, 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.",2020,"No blinding.
","['Inclusion Criteria: - Patients with mild COVID19 (defined as upper respiratory tract infection symptoms in the absence of clinical or radiological signs of pneumonia', 'patients recruited from King Abdulaziz University Hospital, Jeddah, Saudi Arabia', 'stage renal disease requiring dialysis - Severe chronic liver disease', ' Patients with pneumonia or severe illness requiring admission to intensive care unit', 'Protocol version 1, as of July 14, 2020', 'patients with mild COVID-19', '200 eligible patients', ' Adult (18 - 65 years old', 'patients with mild Coronavirus Disease 2019 (COVID-19']","['Nigella sativa supplementation', 'Nigella sativa oil (MARNYS® Cuminmar) 500 mg softgel capsules, one capsule orally twice daily for 10 days plus standard of care treatment (antipyretic, antitussive', 'computer-generated randomization scheme (Random permuted blocks of 10) developed using the web-based program: http://www.randomization.com ', 'Nigella sativa (NS) oil supplementation', 'care treatment', 'oral NS oil']","[' Severe chronic kidney disease', 'Alanine transaminase [AlT] or Aspartate transaminase [AST']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C1140702', 'cui_str': 'Cumin, Black'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3651714', 'cui_str': 'NIGELLA SATIVA SEED OIL'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003419', 'cui_str': 'Antipyretic Agents'}, {'cui': 'C0003449', 'cui_str': 'Antitussive agent'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}]",,0.227921,"No blinding.
","[{'ForeName': 'Abdulrahman E', 'Initials': 'AE', 'LastName': 'Koshak', 'Affiliation': 'Department of Natural Products and Alternative Medicine, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia. aekoshak@kau.edu.sa.'}, {'ForeName': 'Emad A', 'Initials': 'EA', 'LastName': 'Koshak', 'Affiliation': 'Department of Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Abdullah F', 'Initials': 'AF', 'LastName': 'Mobeireek', 'Affiliation': 'Department of Medicine, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mazen A', 'Initials': 'MA', 'LastName': 'Badawi', 'Affiliation': 'Department of Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Siraj O', 'Initials': 'SO', 'LastName': 'Wali', 'Affiliation': 'Department of Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Husam M', 'Initials': 'HM', 'LastName': 'Malibary', 'Affiliation': 'Department of Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Ali F', 'Initials': 'AF', 'LastName': 'Atwah', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, King Abdulaziz University, Rabigh, Saudi Arabia.'}, {'ForeName': 'Meshari M', 'Initials': 'MM', 'LastName': 'Alhamdan', 'Affiliation': 'University Medical Services Centre, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Reem A', 'Initials': 'RA', 'LastName': 'Almalki', 'Affiliation': 'Department of Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Tariq A', 'Initials': 'TA', 'LastName': 'Madani', 'Affiliation': 'Department of Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.'}]",Trials,['10.1186/s13063-020-04647-x']
1823,32771041,Self-weighing frequency and the incidence of type 2 diabetes: post hoc analysis of a cluster-randomized controlled trial.,"OBJECTIVES


Frequent self-weighing is associated with weight loss and maintenance, but the relationship between frequent self-weighing and the incidence of type 2 diabetes (T2D) remains unclear. The study aim was to examine the association between self-weighing frequency and the incidence of T2D in people with impaired fasting glucose (IFG).
RESULTS


We tested the hypothesis that self-weighing frequency and the incidence of T2D are associated in 2607 people with IFG (1240 in the intervention arm; 1367 in the self-directed control arm). Both arms received a weighing scale with storage function. Healthcare providers offered a one-year goal-focused lifestyle intervention via phone. Participants were divided into 4 categories based on self-weighing frequency (No data sent [reference group], low: < 2 times/week, middle: 3-4 times/week, and high: 5-7 times/week). The adjusted hazard ratio (AHR) and 95% confidence interval (CI) were calculated. In the intervention arm, middle- and high-frequency self-weighing were associated with a decreased incidence of T2D relative to the reference group (AHR = 0.56, 95% CI [0.32, 0.98] and AHR = 0.43, 95% CI [0.25, 0.74], respectively). In the control arm, high-frequency self-weighing was also associated with a decreased incidence of T2D relative to the reference group (AHR = 0.54, 95% CI [0.35, 0.83]). Trial registration This trial has been registered with the University Hospital Medical Information Network (UMIN000000662).",2020,"In the intervention arm, middle- and high-frequency self-weighing were associated with a decreased incidence of T2D relative to the reference group (AHR = 0.56, 95% CI [0.32, 0.98] and AHR = 0.43, 95% CI [0.25, 0.74], respectively).","['people with impaired fasting glucose (IFG', '2607 people with IFG (1240 in the intervention arm; 1367 in the self-directed control arm']",[],"['incidence of T2D relative', 'adjusted hazard ratio (AHR) and 95% confidence interval (CI']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}]",2607.0,0.0601543,"In the intervention arm, middle- and high-frequency self-weighing were associated with a decreased incidence of T2D relative to the reference group (AHR = 0.56, 95% CI [0.32, 0.98] and AHR = 0.43, 95% CI [0.25, 0.74], respectively).","[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Sakane', 'Affiliation': 'Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, 1-1 Fukakusamukaihata-cho, Fushimi-ku, Kyoto, 612-8555, Japan. nsakane@gf6.so-net.ne.jp.'}, {'ForeName': 'Yoshitake', 'Initials': 'Y', 'LastName': 'Oshima', 'Affiliation': 'Faculty of Humanities and Social Sciences, University of Marketing and Distribution Sciences, Hyogo, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Kotani', 'Affiliation': 'Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, 1-1 Fukakusamukaihata-cho, Fushimi-ku, Kyoto, 612-8555, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Suganuma', 'Affiliation': 'Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, 1-1 Fukakusamukaihata-cho, Fushimi-ku, Kyoto, 612-8555, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Nirengi', 'Affiliation': 'Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, 1-1 Fukakusamukaihata-cho, Fushimi-ku, Kyoto, 612-8555, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, 1-1 Fukakusamukaihata-cho, Fushimi-ku, Kyoto, 612-8555, Japan.'}, {'ForeName': 'Juichi', 'Initials': 'J', 'LastName': 'Sato', 'Affiliation': 'Department of General Medicine/Family & Community Medicine, Nagoya University Graduate School of Medicine, Aichi, Japan.'}, {'ForeName': 'Sadao', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Department of Public Health, Nagoya City University Graduate School of Medical Sciences, Aichi, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Izumi', 'Affiliation': 'National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Toranomon Hospital Health Management Center, Tokyo, Japan.'}, {'ForeName': 'Mitsuhiko', 'Initials': 'M', 'LastName': 'Noda', 'Affiliation': 'Ichikawa Hospital, International University of Health and Welfare, Chiba, Japan.'}, {'ForeName': 'Hideshi', 'Initials': 'H', 'LastName': 'Kuzuya', 'Affiliation': 'Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, 1-1 Fukakusamukaihata-cho, Fushimi-ku, Kyoto, 612-8555, Japan.'}]",BMC research notes,['10.1186/s13104-020-05215-x']
1824,32771061,The effect of eye movement desensitization and reprocessing on the fear of hypoglycemia in type 2 diabetic patients: a randomized clinical trial.,"BACKGROUND


The fear of hypoglycemia leads to psychological symptoms in patients with diabetes type 2. In this research, the effects of EDMR on the fear of hypoglycemia in patients with diabetes type 2 were examined.
METHODS


A clinical trial study was carried out with participation of 72 patients who had diabetes type 2 in Velayat Hospital. The participants were randomly assigned into control and intervention groups. The intervention group received EMDR. The required information was gleaned using a questionnaire of fear of hypoglycemia, intensity of hypoglycemia, and demographics filled out before the intervention, and 1 month and 3 months after it. The data were analyzed using descriptive statistics on SPSS Version 23. For comparison of fear of hypoglycemia in intervention and control groups, repeated measure ANOVA and Cohen d test were used.
RESULTS


The mean age of the participants in the intervention group was 43.17 ± 10.55 and in the control group was 45.86 ± 13.6. In this study, without considering the potential disruptors in the incorrect model, the intervention caused a reduction of 15 points 1 month after the completion of the intervention and a reduction of 17 points 3 month after the completion of the intervention on the scale of fear of hypoglycemia; but post-correction of potential disruptors, intervention caused a reduction of 19.5 scores 1 month after the completion and a reduction of 20.3 scores 3 months after the intervention .
CONCLUSIONS


The EMDR can be used as a non-pharmaceutical treatment method to treat and alleviate the fear of hypoglycemia in type 2 diabetes patients.
TRIAL REGISTRATION


Iranian Registry of Clinical Trials: IRCT20181201041813N1 , 2019/11/13.",2020,The mean age of the participants in the intervention group was 43.17 ± 10.55 and in the control group was 45.86 ± 13.6.,"['patients with diabetes type 2', 'patients with diabetes type 2 were examined', 'type 2 diabetes patients', '72 patients who had diabetes type 2 in Velayat Hospital', 'type 2 diabetic patients']","['EMDR', 'eye movement desensitization and reprocessing', 'EDMR']","['scale of fear of hypoglycemia', 'fear of hypoglycemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0870535', 'cui_str': 'EMDR'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",,0.0182247,The mean age of the participants in the intervention group was 43.17 ± 10.55 and in the control group was 45.86 ± 13.6.,"[{'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Sheikhi', 'Affiliation': 'Psychiatric Nursing Department, School of Nursing, Qazvin University of Medical Sciences (QUMS), Qazvin, Iran.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Moradi', 'Affiliation': 'Faculty of Nursing and Midwifery, Qazvin University of Medical Science, Qazvin, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Shahsavary', 'Affiliation': 'Health Products Safety Research Center, Qazvin University of Medical Science, Qazvin, Iran.'}, {'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Alimoradi', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Salimi', 'Affiliation': 'Qazvin University of Medical Sciences, Qazvin, Iran. hamidrezasalimi1995@yahoo.com.'}]",BMC psychology,['10.1186/s40359-020-00450-0']
1825,32771068,Testing an early online intervention for the treatment of disturbed sleep during the COVID-19 pandemic (Sleep COVID-19): structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


The primary aim of the present study is to examine the efficacy of an online intervention for poor sleep in the context of an ongoing stressful major life event, by assessing if this intervention can reduce insomnia severity at short-term (one week post-intervention) and long-term (one and three months post-intervention) follow-up time points. It is hypothesised that the intervention will: 1) reduce insomnia severity in poor sleepers, compared to wait-list control poor sleepers, and good sleepers; 2) reduce subjective symptoms of anxiety and depression in all groups, and 3) prevent the transition to acute insomnia in good sleepers.
TRIAL DESIGN


This study is a cluster randomised controlled trial.
PARTICIPANTS


Both healthy good sleepers, who do not report having any current sleep problems, and individuals who report having sleep problems, will be recruited for the present study. This is a single-site study (Northumbria University). This study will be delivered using the internet and there are no geographic restrictions. Individuals who self-report as poor sleepers will meet DSM-5 criteria for acute insomnia, which is where individuals: 1) have difficulties in falling asleep, staying asleep, or awakening too early for at least three nights per week, for a time period of between two weeks and three months; and 2) report experiencing distress or impairment caused by sleep loss. Both 1) and 2) must have occurred despite the individual having had an adequate opportunity for sleep during this time period. Good sleepers will be individuals who do not have current sleep problems. All participants must have a sufficient level of English comprehension to understand and complete study measures. Individuals cannot participate if they report having chronic sleep problems (where they have existed for more than three months immediately prior to providing consent), nor will individuals who are actively seeking treatment for their sleep problems irrespective of how long they have had the sleep problem. Individuals also cannot participate if they have a self-reported history of head injuries, or if they have a self-reported diagnosis of schizophrenia, epilepsy or personality disorder, as the distraction techniques involved in the insomnia intervention may increase rumination in individuals with these conditions, and influence the effectiveness of the intervention.
INTERVENTION AND COMPARATOR


Participants who receive the intervention will be provided with an online version of a self-help leaflet. A printed version of this leaflet has been successfully used in previous treatment studies, which have been conducted by our research group. Participants will be encouraged to download, save or print out this leaflet, which will be provided in PDF format. There will be no restrictions on use and participants will be encouraged to refer to this leaflet as often as they wish to. Briefly, this self-help leaflet aims to improve sleep by identifying and addressing sleep-related dysfunctional thinking by providing education about sleep, providing techniques to distract from intrusive worrisome thoughts at night, and providing guidelines for sleep-related stimulus control. The comparator is a wait-list control (i.e. where they will receive the intervention after a one month delay) group.
MAIN OUTCOMES


The primary outcome measure will be insomnia severity, as measured using the Insomnia Severity Index (Bastien, Vallières, & Morin, 2001), assessed immediately prior to the intervention and at one week, one month and three months post-intervention, compared to baseline. Secondary outcome measures will include subjective mood, measured using the 7-item Generalised Anxiety Disorder Questionnaire (GAD-7; Spitzer, Kroenke, Williams, & Lowe, 2006)) and 9-item Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001), assessed immediately prior to the intervention, and one week, one month and three months post-intervention, compared to baseline. Additionally, subjective sleep continuity, derived from sleep diaries (Carney et al., 2012), will be compared pre and post-intervention.
RANDOMISATION


This study will operate as a cluster randomised controlled trial. Good sleepers will be randomised into an intervention or a no-intervention group, with a 1:1 allocation. Poor sleepers will be randomised into an intervention or wait-list control group, with a 1:1 allocation. Randomisation will be conducted automatically using Qualtrics study software, where block sizes will be equal and randomisation will be computer-generated.
BLINDING (MASKING)


Participants will not be blinded to group assignment. The outcomes will be assessed by a blinded investigator.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


The minimum sample size is 60. A total of 30 poor sleepers will be randomised to the intervention or wait-list control group. A total of 30 good sleepers will be randomised to the intervention or no intervention group.
TRIAL STATUS


Recruitment for this study has yet to start. It is anticipated that recruitment will begin in August 2020 and end in April 2022. The current study protocol is version 1.0 (20 July 2020) TRIAL REGISTRATION: This study was prospectively registered in the ISRCTN registry (registration number ISRCTN43900695 , date of registration: 8 April 2020).
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,"It is hypothesised that the intervention will: 1) reduce insomnia severity in poor sleepers, compared to wait-list control poor sleepers, and good sleepers; 2) reduce subjective symptoms of anxiety and depression in all groups, and 3) prevent the transition to acute insomnia in good sleepers.
","['disturbed sleep during the COVID-19 pandemic (Sleep COVID-19', 'Both healthy good sleepers, who do not report having any current sleep problems, and individuals who report having sleep problems, will be recruited for the present study', 'A total of 30 poor sleepers']",['online intervention'],"['insomnia severity, as measured using the Insomnia Severity Index (Bastien, Vallières, & Morin, 2001), assessed immediately prior to the intervention', 'insomnia severity', 'subjective sleep continuity', 'subjective mood, measured using the 7-item Generalised Anxiety Disorder Questionnaire (GAD-7; Spitzer, Kroenke, Williams, & Lowe, 2006)) and 9-item Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001), assessed immediately prior to the intervention']","[{'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0066801', 'cui_str': 'morin'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]",,0.108244,"It is hypothesised that the intervention will: 1) reduce insomnia severity in poor sleepers, compared to wait-list control poor sleepers, and good sleepers; 2) reduce subjective symptoms of anxiety and depression in all groups, and 3) prevent the transition to acute insomnia in good sleepers.
","[{'ForeName': 'Greg J', 'Initials': 'GJ', 'LastName': 'Elder', 'Affiliation': 'Northumbria Sleep Research, Northumbria University, Newcastle upon Tyne, UK. g.elder@northumbria.ac.uk.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Alfonso-Miller', 'Affiliation': 'Northumbria Sleep Research, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'William C M', 'Initials': 'WCM', 'LastName': 'Atkinson', 'Affiliation': 'Northumbria Sleep Research, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Nayantara', 'Initials': 'N', 'LastName': 'Santhi', 'Affiliation': 'Northumbria Sleep Research, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Ellis', 'Affiliation': 'Northumbria Sleep Research, Northumbria University, Newcastle upon Tyne, UK.'}]",Trials,['10.1186/s13063-020-04644-0']
1826,32771088,"Olaparib and durvalumab in patients with germline BRCA-mutated metastatic breast cancer (MEDIOLA): an open-label, multicentre, phase 1/2, basket study.","BACKGROUND


Poly (ADP-ribose) polymerase inhibitors combined with immunotherapy have shown antitumour activity in preclinical studies. We aimed to assess the safety and activity of olaparib in combination with the PD-L1-inhibitor, durvalumab, in patients with germline BRCA1-mutated or BRCA2-mutated metastatic breast cancer.
METHODS


The MEDIOLA trial is a multicentre, open-label, phase 1/2, basket trial of durvalumab and olaparib in solid tumours. Patients were enrolled into four initial cohorts: germline BRCA-mutated, metastatic breast cancer; germline BRCA-mutated, metastatic ovarian cancer; metastatic gastric cancer; and relapsed small-cell lung cancer. Here, we report on the cohort of patients with breast cancer. Patients who were aged 18 years or older (or aged 19 years or older in South Korea) with germline BRCA1-mutated or BRCA2-mutated or both and histologically confirmed, progressive, HER2-negative, metastatic breast cancer were enrolled from 14 health centres in the UK, the USA, Israel, France, Switzerland, and South Korea. Patients should not have received more than two previous lines of chemotherapy for metastatic breast cancer. Patients received 300 mg olaparib in tablet form orally twice daily for 4 weeks and thereafter a combination of olaparib 300 mg twice daily and durvalumab 1·5 g via intravenous infusion every 4 weeks until disease progression. Primary endpoints were safety and tolerability, and 12-week disease control rate. Safety was analysed in patients who received at least one dose of study treatment, and activity analyses were done in the full-analysis set (patients who received at least one dose of study treatment and were not excluded from the study). Recruitment has completed and the study is ongoing. This trial is registered with ClinicalTrials.gov, NCT02734004.
FINDINGS


Between June 14, 2016, and May 2, 2017, 34 patients were enrolled and received both study drugs and were included in the safety analysis. 11 (32%) patients experienced grade 3 or worse adverse events, of which the most common were anaemia (four [12%]), neutropenia (three [9%]), and pancreatitis (two [6%]). Three (9%) patients discontinued due to adverse events and four (12%) patients experienced a total of six serious adverse events. There were no treatment-related deaths. 24 (80%; 90% CI 64·3-90·9) of 30 patients eligible for activity analysis had disease control at 12 weeks.
INTERPRETATION


Combination of olaparib and durvalumab showed promising antitumour activity and safety similar to that previously observed in olaparib and durvalumab monotherapy studies. Further research in a randomised setting is needed to determine predictors of therapeutic benefit and whether addition of durvalumab improves long-term clinical outcomes compared with olaparib monotherapy.
FUNDING


AstraZeneca.",2020,"24 (80%; 90% CI 64·3-90·9) of 30 patients eligible for activity analysis had disease control at 12 weeks.
","['Patients who were aged 18 years or older (or aged 19 years or older in South Korea) with germline BRCA1-mutated or BRCA2-mutated or both and histologically confirmed, progressive, HER2-negative, metastatic breast cancer were enrolled from 14 health centres in the UK, the USA, Israel, France, Switzerland, and South Korea', 'in solid tumours', 'Patients were enrolled into four initial cohorts: germline BRCA-mutated, metastatic breast cancer; germline BRCA-mutated, metastatic ovarian cancer; metastatic gastric cancer; and relapsed small-cell lung cancer', 'patients with germline BRCA1-mutated or BRCA2-mutated metastatic breast cancer', 'Between June 14, 2016, and May 2, 2017, 34 patients were enrolled and received both study drugs and were included in the safety analysis', 'patients with germline BRCA-mutated metastatic breast cancer (MEDIOLA', 'patients with breast cancer']","['olaparib', 'Olaparib and durvalumab', 'olaparib 300 mg twice daily and durvalumab 1·5 g via intravenous infusion', 'durvalumab and olaparib', 'durvalumab', 'chemotherapy']","['Safety', 'neutropenia', 'total of six serious adverse events', 'anaemia', 'grade 3 or worse adverse events', 'safety and tolerability, and 12-week disease control rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C1528558', 'cui_str': 'BRCA1 protein, human'}, {'cui': 'C2973986', 'cui_str': 'BRCA2 protein, human'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4721779', 'cui_str': 'Ovarian cancer stage IV'}, {'cui': 'C0278498', 'cui_str': 'Gastric cancer stage IV'}, {'cui': 'C0278727', 'cui_str': 'Small cell lung cancer recurrent'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",34.0,0.187663,"24 (80%; 90% CI 64·3-90·9) of 30 patients eligible for activity analysis had disease control at 12 weeks.
","[{'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Domchek', 'Affiliation': 'Basser Center for BRCA, University of Pennsylvania, Philadelphia, PA, USA. Electronic address: susan.domchek@pennmedicine.upenn.edu.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Postel-Vinay', 'Affiliation': 'ATIP -Avenir group, Inserm Unit U981, Villejuif, France; Faculté de Médicine, Le Kremlin Bicêtre, Université Paris Saclay, Université Paris-Sud, Villejuif, France; Department of Drug Development, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of South Korea.'}, {'ForeName': 'Yeon Hee', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of South Korea.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Delord', 'Affiliation': 'Institut Universitaire du Cancer de Toulouse, Toulouse, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Italiano', 'Affiliation': 'Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Alexandre', 'Affiliation': 'Hôpital Cochin, Paris, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'You', 'Affiliation': ""Medical Oncology, Institut de Cancérologie des Hospices Civils de Lyon, Centre d'Investigation de Therapeutiques en Oncologie et H ematologie de Lyon, Centre Hospitalier Lyon-Sud, Lyon, France; Faculté de Médecine Lyon-Sud, Univ Lyon, Université Claude Bernard Lyon 1, EMR UCBL/HCL 3738, Lyon, France; Groupe des Investigateurs Nationaux pour les Cancers de l Ovaire et du sein-GINEGEPS, Paris, France.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Bastian', 'Affiliation': 'Kantonsspital Graubuenden, Chur, Switzerland.'}, {'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Krebs', 'Affiliation': 'Division of Cancer Sciences, Faculty of Biology, Medicine and Health, The University of Manchester and The Christie NHS Foundation Trust, Manchester, UK; Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Henry Ford Medical Center, Detroit, MI, USA.'}, {'ForeName': 'Saiama N', 'Initials': 'SN', 'LastName': 'Waqar', 'Affiliation': 'Washington University School of Medicine, Saint Louis, MO, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lanasa', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Joon', 'Initials': 'J', 'LastName': 'Rhee', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Vidalba', 'Initials': 'V', 'LastName': 'Rocher-Ros', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Emma V', 'Initials': 'EV', 'LastName': 'Jones', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Sakshi', 'Initials': 'S', 'LastName': 'Gulati', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Coenen-Stass', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Iwanka', 'Initials': 'I', 'LastName': 'Kozarewa', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Zhongwu', 'Initials': 'Z', 'LastName': 'Lai', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Helen K', 'Initials': 'HK', 'LastName': 'Angell', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Opincar', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Herbolsheimer', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Bella', 'Initials': 'B', 'LastName': 'Kaufman', 'Affiliation': 'Chaim Sheba Medical Center, Tel Hashomer, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30324-7']
1827,32771106,"Surgery versus cast immobilisation for adults with a bicortical fracture of the scaphoid waist (SWIFFT): a pragmatic, multicentre, open-label, randomised superiority trial.","BACKGROUND


Scaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. The use of immediate surgical fixation to manage this type of fracture has increased, despite insufficient evidence of improved outcomes over non-surgical management. The SWIFFT trial compared the clinical effectiveness of surgical fixation with cast immobilisation and early fixation of fractures that fail to unite in adults with scaphoid waist fractures displaced by 2 mm or less.
METHODS


This pragmatic, parallel-group, multicentre, open-label, two-arm, randomised superiority trial included adults (aged 16 years or older) who presented to orthopaedic departments of 31 hospitals in England and Wales with a clear bicortical fracture of the scaphoid waist on radiographs. An independent remote randomisation service used a computer-generated allocation sequence with randomly varying block sizes to randomly assign participants (1:1) to receive either early surgical fixation (surgery group) or below-elbow cast immobilisation followed by immediate fixation if non-union of the fracture was confirmed (cast immobilisation group). Randomisation was stratified by whether or not there was displacement of either a step or a gap of 1-2 mm inclusive on any radiographic view. The primary outcome was the total patient-rated wrist evaluation (PRWE) score at 52 weeks after randomisation, and it was analysed on an available case intention-to-treat basis. This trial is registered with the ISRCTN registry, ISRCTN67901257, and is no longer recruiting, but long-term follow-up is ongoing.
FINDINGS


Between July 23, 2013, and July 26, 2016, 439 (42%) of 1047 assessed patients (mean age 33 years; 363 [83%] men) were randomly assigned to the surgery group (n=219) or to the cast immobilisation group (n=220). Of these, 408 (93%) participants were included in the primary analysis (203 participants in the surgery group and 205 participants in the cast immobilisation group). 16 participants in the surgery group and 15 participants in the cast immobilisation group were excluded because of either withdrawal, no response, or no follow-up data at 6, 12, 26, or 52 weeks. There was no significant difference in mean PRWE scores at 52 weeks between the surgery group (adjusted mean 11·9 [95% CI 9·2-14·5]) and the cast immobilisation group (14·0 [11·3 to 16·6]; adjusted mean difference -2·1 [95% CI -5·8 to 1·6], p=0·27). More participants in the surgery group (31 [14%] of 219 participants) had a potentially serious complication from surgery than in the cast immobilisation group (three [1%] of 220 participants), but fewer participants in the surgery group (five [2%]) had cast-related complications than in the cast immobilisation group (40 [18%]). The number of participants who had a medical complication was similar between the two groups (four [2%] in the surgery group and five [2%] in the cast immobilisation group).
INTERPRETATION


Adult patients with scaphoid waist fractures displaced by 2 mm or less should have initial cast immobilisation, and any suspected non-unions should be confirmed and immediately fixed with surgery. This treatment strategy will help to avoid the risks of surgery and mostly limit the use of surgery to fixing fractures that fail to unite.
FUNDING


National Institute for Health Research Health Technology Assessment Programme.",2020,"More participants in the surgery group (31 [14%] of 219 participants) had a potentially serious complication from surgery than in the cast immobilisation group (three [1%] of 220 participants), but fewer participants in the surgery group (five [2%]) had cast-related complications than in the cast immobilisation group (40 [18%]).","['adults with scaphoid waist fractures displaced by 2 mm or less', '408 (93%) participants were included in the primary analysis (203 participants in the surgery group and 205 participants in the cast immobilisation group', 'Between July 23, 2013, and July 26, 2016, 439 (42%) of 1047 assessed patients (mean age 33 years; 363 [83%] men', 'young men', 'Adult patients with scaphoid waist fractures displaced by 2 mm or less should have initial cast immobilisation, and any suspected non-unions should be confirmed and immediately fixed with surgery', 'adults (aged 16 years or older) who presented to orthopaedic departments of 31 hospitals in England and Wales with a clear bicortical fracture of the scaphoid waist on radiographs', 'adults with a bicortical fracture of the scaphoid waist (SWIFFT', '16 participants in the surgery group and 15 participants in the cast immobilisation group were excluded because of either withdrawal, no response, or no follow-up data at 6, 12, 26, or 52 weeks']","['Surgery versus cast immobilisation', 'cast immobilisation', 'surgical fixation with cast immobilisation', 'early surgical fixation (surgery group) or below-elbow cast immobilisation followed by immediate fixation if non-union of the fracture was confirmed (cast immobilisation group']","['total patient-rated wrist evaluation (PRWE) score', 'medical complication', 'potentially serious complication', 'mean PRWE scores', 'cast-related complications']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0448063', 'cui_str': 'Entire waist of scaphoid bone'}, {'cui': 'C0585059', 'cui_str': 'Fracture with displacement'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0587525', 'cui_str': 'Orthopedic department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0438837', 'cui_str': 'Below elbow cast'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.175409,"More participants in the surgery group (31 [14%] of 219 participants) had a potentially serious complication from surgery than in the cast immobilisation group (three [1%] of 220 participants), but fewer participants in the surgery group (five [2%]) had cast-related complications than in the cast immobilisation group (40 [18%]).","[{'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Dias', 'Affiliation': 'Leicester General Hospital, University Hospitals of Leicester National Health Service (NHS) Trust, Leicester, UK. Electronic address: jd96@le.ac.uk.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Brealey', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fairhurst', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Rouin', 'Initials': 'R', 'LastName': 'Amirfeyz', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol Royal Infirmary, Bristol, UK.'}, {'ForeName': 'Bhaskar', 'Initials': 'B', 'LastName': 'Bhowal', 'Affiliation': 'Leicester General Hospital, University Hospitals of Leicester National Health Service (NHS) Trust, Leicester, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Blewitt', 'Affiliation': 'North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Brewster', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Brown', 'Affiliation': 'The Royal Liverpool and Broadgreen University Hospitals NHS Trust, Royal Liverpool University Hospital, Liverpool, UK.'}, {'ForeName': 'Surabhi', 'Initials': 'S', 'LastName': 'Choudhary', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Coapes', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Cook', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Costa', 'Affiliation': 'The Kadoorie Centre, John Radcliffe Hospital, Oxford, UK; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Nuffield Orthopaedic Centre, Oxford, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Davis', 'Affiliation': ""Nottingham University Hospitals NHS Trust, Queen's Medical Centre Campus, Nottingham, UK.""}, {'ForeName': 'Livio', 'Initials': 'L', 'LastName': 'Di Mascio', 'Affiliation': 'Barts Health NHS Trust, The Royal London Hospital, London, UK.'}, {'ForeName': 'Grey', 'Initials': 'G', 'LastName': 'Giddins', 'Affiliation': 'Royal United Hospital Bath NHS Trust, Royal United Hospital, Bath, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hedley', 'Affiliation': 'University Hospitals Coventry and Warwickshire NHS Trust, University Hospital, Coventry, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Hinde', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hobby', 'Affiliation': 'Hampshire Hospitals NHS Foundation Trust, Basingstoke and North Hampshire Hospital, Basingstoke, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Hodgson', 'Affiliation': 'Bolton NHS Foundation Trust, Royal Bolton Hospital, Bolton, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Jefferson', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Kanagaratnam', 'Initials': 'K', 'LastName': 'Jeyapalan', 'Affiliation': 'Leicester General Hospital, University Hospitals of Leicester National Health Service (NHS) Trust, Leicester, UK.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Johnston', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'Peterborough and Stamford Hospitals NHS Foundation Trust, Peterborough City Hospital, Peterborough, UK.'}, {'ForeName': 'Ada', 'Initials': 'A', 'LastName': 'Keding', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Leighton', 'Affiliation': ""School of Medicine, University of Nottingham, Queen's Medical Centre, Nottingham, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Logan', 'Affiliation': 'Cardiff and Vale University of Health Board, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Mason', 'Affiliation': 'Gloucestershire Hospitals NHS Foundation Trust, Gloucestershire Royal Hospital, Gloucester, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McAndrew', 'Affiliation': 'Royal Berkshire NHS Foundation Trust, Royal Berkshire Hospital, Reading, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'McNab', 'Affiliation': 'Oxford University Hospitals NHS Trust, Nuffield Orthopaedic Centre, Oxford, UK.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Muir', 'Affiliation': 'Salford Royal Hospital NHS Foundation Trust, Salford, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Nicholl', 'Affiliation': 'Maidstone and Tunbridge Wells NHS Trust, Tunbridge Wells, Kent, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Northgraves', 'Affiliation': 'Hull Health Trials Unit, University of Hull, Hull, UK.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Palmer', 'Affiliation': 'Leicester General Hospital, University Hospitals of Leicester National Health Service (NHS) Trust, Leicester, UK.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Poulter', 'Affiliation': 'Royal Cornwall Hospitals NHS Trust, Royal Cornwall Hospital, Truro, Cornwall, UK.'}, {'ForeName': 'Zulfi', 'Initials': 'Z', 'LastName': 'Rahimtoola', 'Affiliation': 'Royal Berkshire NHS Foundation Trust, Royal Berkshire Hospital, Reading, UK.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Rangan', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Nuffield Orthopaedic Centre, Oxford, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Richards', 'Affiliation': 'Poole Hospital NHS Foundation Trust, Poole, Dorset, UK.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Richardson', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Stuart', 'Affiliation': 'Newcastle upon Tyne Hospitals NHS Foundation Trust, Royal Victoria Infirmary, Newcastle upon Tyne, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Taub', 'Affiliation': 'Department of Health Sciences, University of Leicester, George Davies Centre, Leicester, UK.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Tavakkolizadeh', 'Affiliation': ""King's College Hospital NHS Foundation Trust, King's College Hospital, Brixton, London, UK.""}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Tew', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Department of Health Sciences, University of Leicester, George Davies Centre, Leicester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torgerson', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Warwick', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton General Hospital, Southampton, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)30931-4']
1828,32771267,Effects of listening to music and practicing physical exercise on functional and cognitive aspects in institutionalized older adults with dementia: Pilot study.,"AIM


Determine the effects of listening to music and practicing physical exercise on functional and cognitive aspects in institutionalized older adults with dementia.
METHODS


A randomized clinical pilot trial was conducted involving 17 institutionalized older adults with moderate to advanced dementia. The participants were allocated to two groups: training with music (TWM) and training without music (TWtM). The TWtM group performed light exercises with a focus on mobility. The TWM group was initially submitted to a cognitive stimulus with music, followed by the same exercises as those performed in the TWtM Group. Sessions were held once a week for 12 weeks. Functional and cognitive assessments were performed at baseline and after the 12-week intervention.
RESULTS


No significant differences in functional or cognitive performance were found between groups or evaluation times. Both groups maintained their performances after 12 weeks.
CONCLUSIONS


Listening to music combined with physical exercise training did not exert an effect on functional or cognitive performance in institutionalized older adults with moderate to advanced dementia.",2020,No significant differences in functional or cognitive performance were found between groups or evaluation times.,"['institutionalized older adults with dementia', '17 institutionalized older adults with moderate to advanced dementia', 'institutionalized older adults with moderate to advanced dementia']","['physical exercise training', 'listening to music and practicing physical exercise', 'training with music (TWM) and training without music (TWtM', 'light exercises']","['functional and cognitive aspects', 'Functional and cognitive assessments', 'functional or cognitive performance']","[{'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0023693', 'cui_str': 'Light'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0243151', 'cui_str': 'cognitive aspects'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",17.0,0.0216441,No significant differences in functional or cognitive performance were found between groups or evaluation times.,"[{'ForeName': 'Aline Yumi', 'Initials': 'AY', 'LastName': 'Higuti', 'Affiliation': 'Department of Physical Therapy, Integrated Institute of Health, Federal University of Mato Grosso do Sul, Campo Grande, MS, Brazil.'}, {'ForeName': 'Suzi Rosa Miziara', 'Initials': 'SRM', 'LastName': 'Barbosa', 'Affiliation': 'Department of Physical Therapy, Integrated Institute of Health, Federal University of Mato Grosso do Sul, Campo Grande, MS, Brazil.'}, {'ForeName': 'Lucas Magalhães', 'Initials': 'LM', 'LastName': 'Corrêa', 'Affiliation': 'Department of Physical Therapy, Integrated Institute of Health, Federal University of Mato Grosso do Sul, Campo Grande, MS, Brazil.'}, {'ForeName': 'Tamires Ferri', 'Initials': 'TF', 'LastName': 'Izzo', 'Affiliation': 'Department of Physical Therapy, Integrated Institute of Health, Federal University of Mato Grosso do Sul, Campo Grande, MS, Brazil.'}, {'ForeName': 'Juliana Hotta', 'Initials': 'JH', 'LastName': 'Ansai', 'Affiliation': 'Movement Science Graduate Program, Integrated Institute of Health, Federal University of Mato Grosso do Sul, Brazil; Department of Gerontology, Federal University of São Carlos, São Carlos, SP, Brazil. Electronic address: jhansai@ufscar.br.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2020.07.006']
1829,32771299,Strategies to maximise patient comfort during extracorporeal shockwave lithotripsy - A randomised controlled trial.,"BACKGROUND/PURPOSE OF STUDY


We aim to assess if distraction techniques improve patient comfort tolerability of SWL.
METHODS


We carried out a prospective randomised controlled trial of SWL-naïve patients attending for treatment. Patients were randomised into three groups and offered oral analgesia as standard of care. Group 1 (n = 19) received stress balls to squeeze during treatment. Group 2 (n = 19) listened to music during treatment. Group 3 (n = 17) received standard of care only. All patients completed a validated health anxiety inventory score prior to treatment. All patients completed a validated pain questionnaire and visual analogue scale (VAS) after treatment. Primary outcomes were completion of SWL treatment and pain score results.
RESULTS


55 patients attending for SWL were randomised. There was no difference in stone size or position, presence of a stent, height or weight between the groups. VAS scores were lower in controls compared to Group 1 (1.93 vs 3.69, p = 0.08). On subgroup analysis of non-anxious patients, pain questionnaire scores were lower in controls compared to Group 1 (2.58 vs 4.77, p = 0.06). VAS scores were lower in patients who received optional analgesia alone than in patients who received stress balls alone (1.92 vs 4.07, p = 0.05). Across all subgroups, pain scores were lower in the control group compared to the distraction groups, but did not achieve significance.
CONCLUSIONS


In conclusion, distraction techniques should not replace standard of care for analgesia during SWL. This study was registered with clinicaltrials.gov (identifier NCT03379922).",2020,"Across all subgroups, pain scores were lower in the control group compared to the distraction groups, but did not achieve significance.
","['55 patients attending for SWL', 'naïve patients attending for treatment']","['extracorporeal shockwave lithotripsy', 'SWL', 'standard of care only', 'oral analgesia']","['pain scores', 'validated health anxiety inventory score', 'pain questionnaire scores', 'stone size or position, presence of a stent, height or weight', 'validated pain questionnaire and visual analogue scale (VAS', 'completion of SWL treatment and pain score results', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0015359', 'cui_str': 'Extracorporeal shockwave lithotripsy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",55.0,0.173638,"Across all subgroups, pain scores were lower in the control group compared to the distraction groups, but did not achieve significance.
","[{'ForeName': 'Clíodhna', 'Initials': 'C', 'LastName': 'Browne', 'Affiliation': 'Department of Urology, University College Hospital Galway, Newcastle Road, Galway, Ireland. Electronic address: cliodhnabrowne@rcsi.ie.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Redmond', 'Affiliation': 'Department of Urology, University College Hospital Galway, Newcastle Road, Galway, Ireland.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Kelly', 'Affiliation': 'Department of Urology, University College Hospital Galway, Newcastle Road, Galway, Ireland.'}, {'ForeName': 'Eamonn', 'Initials': 'E', 'LastName': 'Rogers', 'Affiliation': 'Department of Urology, University College Hospital Galway, Newcastle Road, Galway, Ireland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Urology, University College Hospital Galway, Newcastle Road, Galway, Ireland.'}, {'ForeName': 'Nadeem', 'Initials': 'N', 'LastName': 'Nusrat', 'Affiliation': 'Department of Urology, University College Hospital Galway, Newcastle Road, Galway, Ireland.'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Jaffry', 'Affiliation': 'Department of Urology, University College Hospital Galway, Newcastle Road, Galway, Ireland.'}, {'ForeName': 'Garrett', 'Initials': 'G', 'LastName': 'Durkan', 'Affiliation': 'Department of Urology, University College Hospital Galway, Newcastle Road, Galway, Ireland.'}, {'ForeName': 'Kilian', 'Initials': 'K', 'LastName': 'Walsh', 'Affiliation': 'Department of Urology, University College Hospital Galway, Newcastle Road, Galway, Ireland.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Dowling', 'Affiliation': 'Department of Urology, University College Hospital Galway, Newcastle Road, Galway, Ireland.'}, {'ForeName': 'Frank T', 'Initials': 'FT', 'LastName': ""D'Arcy"", 'Affiliation': 'Department of Urology, University College Hospital Galway, Newcastle Road, Galway, Ireland.'}]",The surgeon : journal of the Royal Colleges of Surgeons of Edinburgh and Ireland,['10.1016/j.surge.2020.07.002']
1830,32771321,Time to Loss of Preoxygenation in Emergency Department Patients.,"BACKGROUND


In patients requiring emergency rapid sequence intubation (RSI), 100% oxygen is often delivered for preoxygenation to replace alveolar nitrogen with oxygen. Sometimes, however, preoxygenation devices are prematurely removed from the patient prior to the onset of apnea, which can lead to rapid loss of preoxygenation.
OBJECTIVE


We sought to determine the elapsed time, on average, between removing the oxygen source and the loss of preoxygenation among non-critically ill patients in the emergency department (ED).
METHODS


We conducted a prospective, crossover study of non-critically ill patients in the ED. Each patient received two identical preoxygenation trials for 4 min using a non-rebreather mask with oxygen flow at flush rate and a nasal cannula with oxygen flow at 10 L/min. After each preoxygenation trial, patients underwent two trials in random order while continuing spontaneous breathing: 1) removal of both oxygen sources and 2) removal of non-rebreather mask with nasal cannula left in place. We defined loss of preoxygenation as an end-tidal oxygen (exhaled oxygen percentage; EtO 2 ) value < 70%. We measured EtO 2  breath by breath until loss of preoxygenation occurred.
RESULTS


We enrolled 42 patients, median age was 43 years (interquartile range [IQR] 30 to 54 years) and 72% were male. Median time to loss of preoxygenation was 20 s (IQR 17-25 s, 4.5 breaths) when all oxygen devices were removed, and 39 s (IQR 21-56 s, 8 breaths) when the nasal cannula was left in place.
CONCLUSIONS


In this population of non-critically ill ED patients, most had loss of preoxygenation after 5 breaths if all oxygen devices were removed, and after 8 breaths if a nasal cannula was left in place. These data suggest that during ED RSI, preoxygenation devices should be left in place until the patient is completely apneic.",2020,"Median time to loss of preoxygenation was 20 s (IQR 17-25 s, 4.5 breaths) when all oxygen devices were removed, and 39 s (IQR 21-56 s, 8 breaths) when the nasal cannula was left in place.
","['We enrolled 42 patients, median age was 43\xa0years (interquartile range [IQR] 30 to 54\xa0years) and 72% were male', 'non-critically ill patients in the ED', 'non-critically ill patients in the emergency department (ED', 'patients requiring emergency rapid sequence intubation (RSI', 'Emergency Department Patients']","['oxygen sources and 2) removal of non-rebreather mask with nasal cannula left in place', 'non-rebreather mask with oxygen flow at flush rate and a nasal cannula with oxygen flow']","['Median time to loss of preoxygenation', 'EtO 2  breath by breath until loss of preoxygenation occurred']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C5200706', 'cui_str': 'Rapid Sequence Intubation'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1960093', 'cui_str': 'Nonrebreather oxygen mask'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0005874', 'cui_str': 'Blushing'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0412792', 'cui_str': 'Preoxygenation'}, {'cui': 'C0218234', 'cui_str': 'CBFA2T1 protein, human'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}]",42.0,0.313091,"Median time to loss of preoxygenation was 20 s (IQR 17-25 s, 4.5 breaths) when all oxygen devices were removed, and 39 s (IQR 21-56 s, 8 breaths) when the nasal cannula was left in place.
","[{'ForeName': 'Jarrod', 'Initials': 'J', 'LastName': 'Mosier', 'Affiliation': 'Department of Emergency Medicine and Department of Medicine, Division of Pulmonary, Allergy, Critical Care and Sleep, University of Arizona College of Medicine, Tucson, Arizona.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Reardon', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota.'}, {'ForeName': 'Paige A', 'Initials': 'PA', 'LastName': 'DeVries', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota.'}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Stang', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Nelsen', 'Affiliation': 'Albany Medical College, Albany, New York.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Prekker', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota; Division of Pulmonary/Critical Care, Department of Medicine, Hennepin County Medical Center, Minneapolis, Minnesota.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Driver', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2020.06.064']
1831,32771369,Evaluation of a computerized contraceptive decision aid: a randomized controlled trial.,"OBJECTIVE


To evaluate the effectiveness of a contraceptive decision aid in reducing decisional conflict among women seeking reversible contraception.
STUDY DESIGN


We conducted a randomized trial of a computer-based decision aid compared to a control group for women presenting for reversible contraception at two clinics affiliated with an academic medical center. The primary outcome was change in decisional conflict, measured before and after the healthcare visit using the validated Decisional Conflict Scale. We hypothesized the decision aid would reduce the decisional conflict score by 10 points on a 100-point scale (0=no conflict, 100=high conflict) compared to the control group. Secondary outcomes included contraceptive method chosen and satisfaction with the healthcare visit.
RESULTS


We enrolled and randomized 253 women, and 241 had complete data for our primary outcome. Overall, pre-visit decisional conflict scores were low, reflecting low levels of decisional conflict in our sample; median score 15 (range 0 to 80) in the decision aid and 10 (0 to 85) in the control group (p=0.45). Both groups had a similar reduction in median decisional conflict after the healthcare visit: -10 (-80 to 25) and -10 (-60 to 5) in the decision aid and control groups respectively (p=0.99). Choice of contraception (p=0.23) and satisfaction with healthcare provider (p=0.79) also did not differ by study group.
CONCLUSIONS


Decisional conflict around contraception was low in both groups at baseline. Use of a computerized contraceptive decision aid did not reduce decisional conflict, alter method choice, or impact satisfaction compared to the control group among women choosing reversible contraception.
IMPLICATIONS


Use of a computerized contraceptive decision aid did not reduce decisional conflict or alter method choice compared to the control group among women choosing reversible contraception. Future studies could focus on testing the decision aid in different clinical settings, especially where barriers to providing comprehensive contraceptive counseling exist.",2020,"IMPLICATIONS


Use of a computerized contraceptive decision aid did not reduce decisional conflict or alter method choice compared to the control group among women choosing reversible contraception.","['women presenting for reversible contraception at two clinics affiliated with an academic medical center', 'women seeking reversible contraception', 'We enrolled and randomized 253 women, and 241 had complete data for our primary outcome']",['contraceptive decision aid'],"['contraceptive method chosen and satisfaction with the healthcare visit', 'change in decisional conflict, measured before and after the healthcare visit using the validated Decisional Conflict Scale', 'decisional conflict score', 'decisional conflict, alter method choice, or impact satisfaction', 'median decisional conflict', 'Overall, pre-visit decisional conflict scores', 'decisional conflict']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}]","[{'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]",253.0,0.126585,"IMPLICATIONS


Use of a computerized contraceptive decision aid did not reduce decisional conflict or alter method choice compared to the control group among women choosing reversible contraception.","[{'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Madden', 'Affiliation': 'Divisions of Family Planning & Clinical Research Department of Obstetrics and Gynecology Washington University in St. Louis School of Medicine 4901 Forest Park Avenue, Mailstop: 8064-37-1005, St. Louis, Missouri 63108, USA. Electronic address: maddent@wustl.edu.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Holttum', 'Affiliation': ""Department of Obstetrics, Gynecology and Women's Health University of Minnesota Medical School 515 Mayo Memorial Building, Moos Tower 12(th) Floor, Minneapolis, MN 55455, USA.""}, {'ForeName': 'Ragini', 'Initials': 'R', 'LastName': 'Maddipati', 'Affiliation': 'Brown School Washington University in St. Louis 1 Brookings Dr, St. Louis, MO 63130, USA.'}, {'ForeName': 'Gina M', 'Initials': 'GM', 'LastName': 'Secura', 'Affiliation': 'Divisions of Family Planning & Clinical Research Department of Obstetrics and Gynecology Washington University in St. Louis School of Medicine 4901 Forest Park Avenue, Mailstop: 8064-37-1005, St. Louis, Missouri 63108, USA.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Nease', 'Affiliation': 'ExpressScripts 1 Express Way, St. Louis, MO 63121, USA.'}, {'ForeName': 'Jeffrey F', 'Initials': 'JF', 'LastName': 'Peipert', 'Affiliation': 'Department of Obstetrics and Gynecology Indiana University School of Medicine 550 University Blvd, University Hospital 2440, Indianapolis, IN 46202, USA.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Politi', 'Affiliation': 'Division of Public Health Sciences Department of Surgery Washington University in St. Louis School of Medicine, 660 S. Euclid, Campus Box 8100, St. Louis, MO 63108, USA.'}]",Contraception,['10.1016/j.contraception.2020.08.002']
1832,32771424,Evaluating the impact of the antrum size following laparoscopic sleeve gastrectomy: a randomized multicenter study.,"BACKGROUND


The effect of laparoscopic sleeve gastrectomy (LSG) on gastroesophageal reflux disease (GERD) remains discordant and highly related to the surgical technique. GERD and weight regain are probably understudied by prospective clinical studies depending on different technical factors.
OBJECTIVES


The purpose of this article is to evaluate the effect of extent to which the antrum is resected on GERD following LSG but also on early complications and short-term weight loss results.
SETTING


University Hospital, France.
METHODS


Patients were randomly assigned in group A (172 patients), LSG with antral resection, or group B (174 patients), LSG with antral preservation. The baseline characteristics collected were demographic characteristics and anthropometric data (age, sex, body mass index), presence of GERD clinical characteristics, ± pH-metry, postoperative complications, or gastrin level.
RESULTS


A total of 279 patients underwent LSG and they were included in the final analysis. The GERD analyzed at 3 months postoperatively by pH-metry was observed for 57.8% in group A and for 52.4% of patients in group B (P = .4819). There was no statistically significant difference (P = .3755) between the 2 groups at 1 year after surgery (group A, 49.5% versus group B, 43.6%). The gastrin serum level was analyzed 1 year after surgery for a total of 107 patients. For group A, the mean gastrin level was 97.4 ± 85.9 pg/mL, which was inferior compared with group B (150.6 ± 152.4 pg/mL) with no statistical difference (P = .067). The recorded excess weight loss for group A was 79.67% (± 28.88) with no statistically significant difference with group B 74.46% (± 36.61) (P = .3678). The mortality rate was nil. We recorded 5 cases of staple line leakage (3 in group A and 2 in group B); 11 patients presented bleeding (3 in group A and 8 group B), and 4 patients presented with gastric stenosis (2 in group A and 2 in group B).
CONCLUSIONS


The antrum preservation has no significant difference in terms of reflux, weight loss, or complications at 3 or 12 months following LSG. The only significant difference was achieved for nausea and vomiting symptoms, which were more significant for the antrum resection group. Further clinical trials with newer procedures will indicate the factors that can diminish the reflux following LSG. Furthermore, the conservation of a large part of the antrum may be helpful to convert the sleeve to another bariatric procedure (transit bipartition).",2020,"The antrum preservation has no significant difference in terms of reflux, weight loss, or complications at 3 or 12 months following LSG.","['Patients were randomly assigned in group A (172 patients', '279 patients underwent LSG and they were included in the final analysis', 'University Hospital, France']","['LSG with antral resection', 'laparoscopic sleeve gastrectomy', 'LSG with antral preservation', 'laparoscopic sleeve gastrectomy (LSG']","['demographic characteristics and anthropometric data (age, sex, body mass index), presence of GERD clinical characteristics, ± pH-metry, postoperative complications, or gastrin level', 'excess weight loss', 'GERD and weight regain', 'gastroesophageal reflux disease (GERD', 'mean gastrin level', 'nausea and vomiting symptoms', 'mortality rate', 'reflux, weight loss, or complications', 'bleeding', 'gastrin serum level', 'staple line leakage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0202036', 'cui_str': 'Gastrin measurement'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0017151', 'cui_str': 'Gastrins'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}]",279.0,0.0340159,"The antrum preservation has no significant difference in terms of reflux, weight loss, or complications at 3 or 12 months following LSG.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nocca', 'Affiliation': 'Unité bariatrique CHU de Montpellier, Montpellier, France; Université Montpellier 1, Montpellier, France. Electronic address: d-nocca@chu-montpellier.fr.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Picot', 'Affiliation': ""Université Montpellier 1, Montpellier, France; Département Information Médicale, Unité de Recherche Clinique et Epidémiologie, INSERM, Centre d'Investigation Clinique 1411, Montpellier, France.""}, {'ForeName': 'Ion', 'Initials': 'I', 'LastName': 'Donici', 'Affiliation': 'CHU Nimes, Nimes, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Emungania', 'Affiliation': 'CHU Hôpital Nord, Marseille, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Jaussent', 'Affiliation': ""Département Information Médicale, Unité de Recherche Clinique et Epidémiologie, INSERM, Centre d'Investigation Clinique 1411, Montpellier, France.""}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Akouete', 'Affiliation': ""Département Information Médicale, Unité de Recherche Clinique et Epidémiologie, INSERM, Centre d'Investigation Clinique 1411, Montpellier, France.""}, {'ForeName': 'Alexandrine', 'Initials': 'A', 'LastName': 'Robert', 'Affiliation': 'Unité bariatrique CHU de Montpellier, Montpellier, France.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Nedelcu', 'Affiliation': 'ELSAN, Clinique Saint Michel, Toulon, France; ELSAN, Clinique Bouchard, Marseille, France.'}, {'ForeName': 'Anamaria', 'Initials': 'A', 'LastName': 'Nedelcu', 'Affiliation': 'ELSAN, Clinique Saint Michel, Toulon, France.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.06.041']
1833,32771433,Use of nasal mucosa graft in tympanoplasty.,"INTRODUCTION


Tympanoplasty techniques with different types of graft have been used to close tympanic perforations since the 19th century. Tragal cartilage and temporalis fascia are the most frequently used types of graft. They lead to similar functional and morphological results in most cases. Although little published evidence is present, nasal mucosa has also been shown to be a good alternative graft.
OBJECTIVE


Surgical and audiological outcomes at the six-month follow-up in type I tympanoplasty using nasal mucosa and temporalis fascia grafts were analyzed.
METHODS


A total of 40 candidates for type I tympanoplasty were randomly selected and divided into the nasal mucosa and temporalis fascia graft groups with 20 in each group. The assessed parameters included surgical success; the rate of complete closure of tympanic perforation and hearing results; the difference between post- and pre-operative mean quadritonal airway-bone gap, six months after surgery.
RESULTS


Complete closure of the tympanic perforation was achieved in 17 of 20 patients in both groups. The mean quadritonal airway-bone gap closures were11.9 and 11.1 dB for the nasal mucosa and temporalis fascia groups, respectively. There was no statistically significant difference between the groups.
CONCLUSION


The nasal mucosa graft can be considered similar to the temporal fascia when considering the surgical success rate of graft acceptance and ultimate audiological gain.",2020,"There was no statistically significant difference between the groups.
",['A total of 40 candidates for type I tympanoplasty'],[],"['tympanic perforation', 'surgical success; the rate of complete closure of tympanic perforation and hearing results; the difference between post- and pre-operative mean quadritonal airway-bone gap, six months after surgery', 'mean quadritonal airway-bone gap closures']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}]",[],"[{'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",40.0,0.0387851,"There was no statistically significant difference between the groups.
","[{'ForeName': 'Sandro Barros', 'Initials': 'SB', 'LastName': 'Coelho', 'Affiliation': 'Universidade Federal do Ceará, Hospital Universitário Walter Cantídeo, Fortaleza, CE, Brazil. Electronic address: sandrocoelhomd@gmail.com.'}, {'ForeName': 'Willian da Silva', 'Initials': 'WDS', 'LastName': 'Lopes', 'Affiliation': 'Universidade Federal do Maranhão, Otoclínica, Imperatriz, MA, Brazil.'}, {'ForeName': 'Gabriela de Andrade Meireles', 'Initials': 'GAM', 'LastName': 'Bezerra', 'Affiliation': 'Universidade Federal do Ceará, Hospital Universitário Walter Cantídeo, Fortaleza, CE, Brazil.'}, {'ForeName': 'Davi Farias de', 'Initials': 'DF', 'LastName': 'Araújo', 'Affiliation': 'Universidade Federal do Ceará, Hospital Universitário Walter Cantídeo, Fortaleza, CE, Brazil.'}, {'ForeName': 'Adriano Sérgio Freire', 'Initials': 'ASF', 'LastName': 'Meira', 'Affiliation': 'SOS Otorrino ENT Clinic, João Pessoa, PB, Brazil.'}, {'ForeName': 'Sílvio da Silva', 'Initials': 'SDS', 'LastName': 'Caldas Neto', 'Affiliation': 'Universidade Federal de Pernambuco, Recife, PE, Brazil.'}]",Brazilian journal of otorhinolaryngology,['10.1016/j.bjorl.2020.06.006']
1834,32771456,Phaco-endocycloplasty versus Phacotrabeculectomy in Primary Angle-Closure Glaucoma: A Prospective Randomized Study.,"PURPOSE


To investigate the efficacy and safety of endocycloplasty (ECPL) versus trabeculectomy when it is combined with phacotrabeculectomy in medically controlled or uncontrolled primary angle-closure (PAC) or primary angle-closure glaucoma (PACG) after laser peripheral iridotomy (LPI).
DESIGN


Prospective, interventional, randomized control trial.
PARTICIPANTS


Subjects with PAC/PACG aged 30 years or more after LPI with visually significant cataract.
METHODS


Subjects underwent computer-generated randomized sequence of either procedure, phaco-ECPL or phacotrabeculectomy, for standard indications of combined glaucoma and cataract surgery.
MAIN OUTCOME MEASURES


Primary outcome measure was intraocular pressure (IOP). Secondary outcome measures were best-corrected visual acuity (BCVA), number of antiglaucoma medications (AGMs), complications, and failure.
RESULTS


A total of 45 eyes of 39 subjects were included. A total of 25 eyes underwent phaco-ECPL, and 20 eyes underwent phacotrabeculectomy. Five eyes in the phaco-ECPL group were excluded; 2 were excluded because laser was not delivered per protocol, and the rest had less than 3 months of follow-up. Mean follow-up was 16.25±8.1 months in the phaco-ECPL group and 18.9±9.5 months in the phacotrabeculectomy group. Mean preoperative and postoperative IOP, AGM, and BCVA did not differ between the groups. However, the rate of complications (P = 0.011) and interventions (P = 0.047) was greater in the phacotrabeculectomy group.
CONCLUSIONS


Both procedures are efficacious in lowering IOP in PACG, but the rate of complication and interventions for these were more in the phacotrabeculectomy group. Longer follow-up is indicated to probe the feasibility of phaco-ECPL, a minimally invasive procedure, as first-step management in PAC disease, for which combined cataract and glaucoma surgery is indicated.",2020,"However, the rate of complications (P = 0.011) and interventions (P = 0.047) was greater in the phacotrabeculectomy group.
","['A total of 45 eyes of 39 subjects were included', 'Subjects with PAC/PACG aged 30 years or more after LPI with visually significant cataract', 'Primary Angle-Closure Glaucoma', 'Subjects underwent computer-generated randomized sequence of either', 'medically controlled or uncontrolled primary angle-closure (PAC) or primary angle-closure glaucoma (PACG) after laser peripheral iridotomy (LPI']","['procedure, phaco-ECPL or phacotrabeculectomy, for standard indications of combined glaucoma and cataract surgery', 'Phaco-endocycloplasty versus Phacotrabeculectomy', 'phacotrabeculectomy', 'phaco-ECPL', 'endocycloplasty (ECPL) versus trabeculectomy']","['intraocular pressure (IOP', 'best-corrected visual acuity (BCVA), number of antiglaucoma medications (AGMs), complications, and failure', 'rate of complications', 'Mean preoperative and postoperative IOP, AGM, and BCVA']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0429528', 'cui_str': 'Angle closure'}, {'cui': 'C0017605', 'cui_str': 'Angle-closure glaucoma'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0395459', 'cui_str': 'Laser iridotomy'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1167708', 'cui_str': 'Phacotrabeculectomy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}]","[{'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",39.0,0.155981,"However, the rate of complications (P = 0.011) and interventions (P = 0.047) was greater in the phacotrabeculectomy group.
","[{'ForeName': 'Vanita', 'Initials': 'V', 'LastName': 'Pathak-Ray', 'Affiliation': 'Centre for Sight, Hyderabad, India. Electronic address: vpathakray@gmail.com.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Choudhari', 'Affiliation': 'VST Centre for Glaucoma, L V Prasad Eye Institute, L V Prasad Marg, Hyderabad, India.'}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2020.06.006']
1835,32771678,Gamma transcranial alternating current stimulation improves mood and cognition in patients with major depression.,"Major depression is one of the most common psychiatric disorders with a high rate of treatment resistance where new treatment options are urgently warranted. One of these new options are non-invasive brain stimulation techniques like transcranial magnetic or electric stimulation. One of the latter is transcranial Alternating Current Stimulation (tACS) in various frequencies. Here, we report a case series of six patients suffering from major depression treated with tACS in gamma (40 Hz) frequency. Patients were randomized to two groups, receiving either two 10-min stimulations (group 1) or a 20-min stimulation or per day (group 2) over ten days. Hamilton Depression Rating Scale and Beck Depression Inventory decreased during treatment in both study groups by 85% and 78% (group 1), or 62% and 24% respectively (group 2). Results also showed an improvement in cognitive functions assessed by word fluency and n-back test. It is hypothesized that gamma tACS could help to synchronize disturbed frequency bands in frontal and prefrontal cortex areas and thus restore dysbalanced neural connectivity in psychiatric disorders.",2020,"Hamilton Depression Rating Scale and Beck Depression Inventory decreased during treatment in both study groups by 85% and 78% (group 1), or 62% and 24% respectively (group 2).","['six patients suffering from major depression treated with tACS in gamma (40\xa0Hz) frequency', 'patients with major depression']","['Gamma transcranial alternating current stimulation', 'transcranial Alternating Current Stimulation (tACS', 'gamma tACS']","['Hamilton Depression Rating Scale and Beck Depression Inventory', 'cognitive functions assessed by word fluency and n-back test', 'mood and cognition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]","[{'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",,0.0221377,"Hamilton Depression Rating Scale and Beck Depression Inventory decreased during treatment in both study groups by 85% and 78% (group 1), or 62% and 24% respectively (group 2).","[{'ForeName': 'Nikolas', 'Initials': 'N', 'LastName': 'Haller', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Senner', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany; Institute of Psychiatric Phenomics and Genomics (IPPG), Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Andre R', 'Initials': 'AR', 'LastName': 'Brunoni', 'Affiliation': 'Department and Institute of Psychiatry, Laboratory of Neurosciences (LIM-27), University of Sao Paulo, Brazil.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Palm', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany; Medical Park Chiemseeblick, Bernau, Felden, Germany. Electronic address: u.palm@medicalpark.de.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.009']
1836,32762663,"A multi-centre, double-blind, 12-week, randomized, placebo-controlled trial to assess the efficacy of adjunctive N-Acetylcysteine for treatment-resistant PTSD: a study protocol.","BACKGROUND


Most patients with Posttraumatic Stress Disorder (PTSD) suffer residual symptoms following first-line treatment. Oxidative stress has been implicated in the pathophysiology of PTSD. N-acetylcysteine (NAC) is a precursor of the brain's primary antioxidant, glutathione, and may diminish oxidative cellular damage. An 8-week pilot study of NAC in veterans with PTSD found that symptoms were significantly reduced in the NAC group compared to placebo. This study aims to confirm these findings with a larger sample in a double-blind, placebo-controlled trial to further explore the efficacy of NAC as an adjunctive therapy in treatment-resistant PTSD.
METHODS


A multicentre, randomised, double-blind, placebo-controlled trial for adult patients who still meet criteria for PTSD following first-line treatment. The intervention comprises either NAC as a fixed dose regime of 2.7 g/day (900 mg three times daily) administered orally for 12 weeks, or placebo. Standard care for PTSD will continue in addition, including other pharmacotherapies. Detailed clinical data will be collected at randomisation and weeks 4, 8, 12, 16, and 64 post-randomisation, with self-report measures completed weekly from baseline to 16 weeks and at 64 weeks post-randomisation. Blood-based biomarkers will be collected at baseline and 12 weeks to assess the mechanism of effect. The primary outcome measure will be change in Clinician-Administered PTSD Scale for DSM-5 at 12 weeks compared with baseline. Secondary outcomes will be change in quality of life, depression, anxiety, substance use and craving, and somatic symptoms. With 126 completed participants (63 per arm), the study is powered at 80% to detect a true difference in the primary outcome measure using a two-tailed analysis with alpha = 0.05, beta = 0.2.
DISCUSSION


This is the first multicentre, double blind, randomised, placebo-controlled trial of adjunctive NAC for treatment-resistant PTSD. NAC has an established safety profile, is readily available and easy to administer, and has a favourable tolerability profile, therefore making it an attractive adjunctive therapy. Inclusion of blood analyses to assess potential target engagement biomarkers of oxidative stress and neuroinflammation may help gauge the biological mechanisms of effect of NAC.
TRIAL REGISTRATION


ACTRN12618001784202, retrospectively registered 31/10/2018, URL: http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376004 .",2020,An 8-week pilot study of NAC in veterans with PTSD found that symptoms were significantly reduced in the NAC group compared to placebo.,"['veterans with PTSD', 'adult patients who still meet criteria for PTSD following first-line treatment', 'patients with Posttraumatic Stress Disorder (PTSD']","['N-acetylcysteine (NAC', 'adjunctive N-Acetylcysteine', 'NAC', 'adjunctive NAC', 'placebo']","['change in Clinician-Administered PTSD Scale for DSM-5', 'change in quality of life, depression, anxiety, substance use and craving, and somatic symptoms']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}]",126.0,0.718824,An 8-week pilot study of NAC in veterans with PTSD found that symptoms were significantly reduced in the NAC group compared to placebo.,"[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Maier', 'Affiliation': 'Department of Psychiatry, Austin Health, University of Melbourne, LTB10, 145 Studley Road, Heidelberg, VIC, 3084, Australia.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Dharan', 'Affiliation': 'Department of Psychiatry, Austin Health, University of Melbourne, LTB10, 145 Studley Road, Heidelberg, VIC, 3084, Australia.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Oliver', 'Affiliation': 'Department of Psychiatry, The Melbourne Clinic, University of Melbourne, Richmond, VIC, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'IMPACT - the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Deakin University, Barwon Health, Geelong, Australia.'}, {'ForeName': 'Suzy', 'Initials': 'S', 'LastName': 'Redston', 'Affiliation': 'Austin Health, Heidelberg, VIC, Australia.'}, {'ForeName': 'Sudie E', 'Initials': 'SE', 'LastName': 'Back', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina; Ralph H. Johnson VA Medical Center, Charleston, SC, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kalivas', 'Affiliation': 'Department of Neuroscience, Medical University of South Carolina, Charleston, USA.'}, {'ForeName': 'Chee', 'Initials': 'C', 'LastName': 'Ng', 'Affiliation': 'Department of Psychiatry, The Melbourne Clinic, University of Melbourne, Richmond, VIC, Australia.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Kanaan', 'Affiliation': 'Department of Psychiatry, Austin Health, University of Melbourne, LTB10, 145 Studley Road, Heidelberg, VIC, 3084, Australia. richard.kanaan@unimelb.edu.au.'}]",BMC psychiatry,['10.1186/s12888-020-02793-9']
1837,32762677,A randomized controlled trial comparing the clinical efficacy and cost-effectiveness of eye movement desensitization and reprocessing (EMDR) and integrated EMDR-Dialectical Behavioural Therapy (DBT) in the treatment of patients with post-traumatic stress disorder and comorbid (Sub)clinical borderline personality disorder: study design.,"BACKGROUND


Comorbidity between Posttraumatic Stress Disorder (PTSD) and Borderline Personality Disorder (BPD) is high. There is growing motivation among clinicians to offer PTSD treatments - such as Eye Movement Desensitization and Reprocessing (EMDR) - to patients with PTSD and comorbid BPD. However, a large subgroup with comorbid BPD does not sufficiently respond to PTSD treatment and is more likely to be excluded or to dropout from treatment. Dialectical Behaviour Therapy (DBT) for BPD is well established and although there is some evidence that DBT combined with DBT Prolonged Exposure (DBT + DBT PE) is twice as effective in reducing PTSD symptoms than DBT alone, the comparative efficacy of integrated PTSD-DBT and PTSD-only treatment has not been investigated yet. The current study will therefore evaluate the comparative clinical efficacy and cost-effectiveness of EMDR-DBT and EMDR-only in patients with PTSD and comorbid (sub)clinical BPD. Moreover, it is not clear yet what treatment works best for which individual patient. The current study will therefore evaluate neurobiological predictors and mediators of the individual response to treatment.
METHOD


A randomized controlled trial comparing the clinical efficacy and cost-effectiveness of integrated EMDR-DBT (n = 63) and EMDR-only (n = 63) in treatment-seeking adult patients with PTSD and comorbid (sub)clinical BPD. In addition, neurobiological predictors and mediators of treatment outcome, such as hair cortisol, FKBP5 and BDNF protein levels and FKBP5 and BDNF methylation status, are measured through hair and blood samples.
DISCUSSION


This is the first study to compare the clinical efficacy and cost-effectiveness of integrated EMDR-DBT and EMDR-only in patients with PTSD and comorbid (sub)clinical BPD, while simultaneously identifying individual predictors and mediators of treatment response. Results will reveal which treatment works best for which individual patient, thereby guiding individual treatment choices and personalizing psychiatry.
TRIAL REGISTRATION


Clinical Trials, NCT03833453 . Retrospectively registered, 15 March 2019.",2020,There is growing motivation among clinicians to offer PTSD treatments - such as Eye Movement Desensitization and Reprocessing (EMDR) - to patients with PTSD and comorbid BPD.,"['patients with PTSD and comorbid (sub)clinical BPD', 'adult patients with PTSD and comorbid (sub)clinical BPD', 'patients with post-traumatic stress disorder and comorbid (Sub)clinical borderline personality disorder']","['integrated EMDR-DBT (n\u2009=\u200963) and EMDR-only (n\u2009=\u200963) in treatment-seeking', 'EMDR-DBT and EMDR', 'DBT Prolonged Exposure (DBT\u2009+\u2009DBT PE', 'Dialectical Behaviour Therapy (DBT', 'eye movement desensitization and reprocessing (EMDR) and integrated EMDR-Dialectical Behavioural Therapy (DBT', 'integrated EMDR-DBT and EMDR']","['PTSD symptoms', 'hair cortisol, FKBP5 and BDNF protein levels and FKBP5 and BDNF methylation status, are measured through hair and blood samples']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0870535', 'cui_str': 'EMDR'}, {'cui': 'C3472347', 'cui_str': 'Digital breast tomosynthesis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1321145', 'cui_str': 'Dialectical behavior therapy'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1741214', 'cui_str': 'FKBP5 protein, human'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",,0.0204819,There is growing motivation among clinicians to offer PTSD treatments - such as Eye Movement Desensitization and Reprocessing (EMDR) - to patients with PTSD and comorbid BPD.,"[{'ForeName': 'Aishah', 'Initials': 'A', 'LastName': 'Snoek', 'Affiliation': 'Arkin Sinai Centrum, Amstelveen, The Netherlands. aishah.snoek@sinaicentrum.nl.'}, {'ForeName': 'Aartjan T F', 'Initials': 'ATF', 'LastName': 'Beekman', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam, the Netherlands.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Dekker', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Anatomy and Neurosciences, Amsterdam Neuroscience, Amsterdam, the Netherlands.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Aarts', 'Affiliation': 'Arkin Sinai Centrum, Amstelveen, The Netherlands.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'van Grootheest', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam, the Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Blankers', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam, the Netherlands.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Vriend', 'Affiliation': 'Vrije Universiteit Amsterdam, Faculty of Behavioural and Movement Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'van den Heuvel', 'Affiliation': 'Vrije Universiteit Amsterdam, Faculty of Behavioural and Movement Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Thomaes', 'Affiliation': 'Arkin Sinai Centrum, Amstelveen, The Netherlands.'}]",BMC psychiatry,['10.1186/s12888-020-02713-x']
1838,32762701,"High-flow nasal cannula oxygen therapy versus non-invasive ventilation for chronic obstructive pulmonary disease patients after extubation: a multicenter, randomized controlled trial.","BACKGROUND


High-flow nasal cannula (HFNC) oxygen therapy is being increasingly used to prevent post-extubation hypoxemic respiratory failure and reintubation. However, evidence to support the use of HFNC in chronic obstructive pulmonary disease (COPD) patients with hypercapnic respiratory failure after extubation is limited. This study was conducted to test if HFNC is non-inferior to non-invasive ventilation (NIV) in preventing post-extubation treatment failure in COPD patients previously intubated for hypercapnic respiratory failure.
METHODS


COPD patients with hypercapnic respiratory failure who were already receiving invasive ventilation were randomized to HFNC or NIV at extubation at two large tertiary academic teaching hospitals. The primary endpoint was treatment failure, defined as either resumption of invasive ventilation or switching to the other study treatment modality (NIV for patients in the NFNC group or vice versa).
RESULTS


Ninety-six patients were randomly assigned to the HFNC group or NIV group. After secondary exclusion, 44 patients in the HFNC group and 42 patients in the NIV group were included in the analysis. The treatment failure rate in the HFNC group was 22.7% and 28.6% in the NIV group-risk difference of - 5.8% (95% CI, - 23.8-12.4%, p = 0.535), which was significantly lower than the non-inferior margin of 9%. Analysis of the causes of treatment failure showed that treatment intolerance in the HFNC group was significantly lower than that in the NIV group, with a risk difference of - 50.0% (95% CI, - 74.6 to - 12.9%, p = 0.015). One hour after extubation, the mean respiratory rates of both groups were faster than their baseline levels before extubation (p < 0.050). Twenty-four hours after extubation, the respiratory rate of the HFNC group had returned to baseline, but the NIV group was still higher than the baseline. Forty-eight hours after extubation, the respiratory rates of both groups were not significantly different from the baseline. The average number of daily airway care interventions in the NIV group was 7 (5-9.3), which was significantly higher than 6 (4-7) times in the HFNC group (p = 0.006). The comfort score and incidence of nasal and facial skin breakdown of the HFNC group was also significantly better than that of the NIV group [7 (6-8) vs 5 (4-7), P < 0.001] and [0 vs 9.6%, p = 0.027], respectively.
CONCLUSION


Among COPD patients with severe hypercapnic respiratory failure who received invasive ventilation, the use of HFNC after extubation did not result in increased rates of treatment failure compared with NIV. HFNC also had better tolerance and comfort than NIV.
TRIAL REGISTRATION


chictr.org ( ChiCTR1800018530 ). Registered on 22 September 2018, http://www.chictr.org.cn/usercenter.aspx.",2020,"The treatment failure rate in the HFNC group was 22.7% and 28.6% in the NIV group-risk difference of - 5.8% (95% CI, - 23.8-12.4%, p = 0.535), which was significantly lower than the non-inferior margin of 9%.","['COPD patients previously intubated for hypercapnic respiratory failure', 'COPD patients with severe hypercapnic respiratory failure who received', 'Ninety-six patients', '44 patients in the HFNC group and 42 patients in the NIV group were included in the analysis', 'chronic obstructive pulmonary disease (COPD) patients with hypercapnic respiratory failure after extubation', 'COPD patients with hypercapnic respiratory failure who were already receiving invasive ventilation were randomized to HFNC or NIV at extubation at two large tertiary academic teaching hospitals', 'chronic obstructive pulmonary disease patients after extubation']","['High-flow nasal cannula ', 'invasive ventilation', 'HFNC) oxygen therapy', 'HFNC', 'High-flow nasal cannula oxygen therapy versus non-invasive ventilation']","['rates of treatment failure', 'treatment failure rate', 'respiratory rates', 'treatment failure, defined as either resumption of invasive ventilation or switching to the other study treatment modality (NIV', 'mean respiratory rates', 'comfort score and incidence of nasal and facial skin breakdown', 'respiratory rate', 'average number of daily airway care interventions']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0398353', 'cui_str': 'Hypercapnic respiratory failure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C4761117', 'cui_str': 'High-flow nasal cannula oxygen therapy'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}]","[{'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0222084', 'cui_str': 'Skin structure of face'}, {'cui': 'C0699900', 'cui_str': 'Catabolism'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",96.0,0.196719,"The treatment failure rate in the HFNC group was 22.7% and 28.6% in the NIV group-risk difference of - 5.8% (95% CI, - 23.8-12.4%, p = 0.535), which was significantly lower than the non-inferior margin of 9%.","[{'ForeName': 'Dingyu', 'Initials': 'D', 'LastName': 'Tan', 'Affiliation': ""Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.""}, {'ForeName': 'Joseph Harold', 'Initials': 'JH', 'LastName': 'Walline', 'Affiliation': 'Accident and Emergency Medicine Academic Unit, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Bingyu', 'Initials': 'B', 'LastName': 'Ling', 'Affiliation': ""Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.""}, {'ForeName': 'Jiayan', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': ""Pharmacy Department, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China. 32494845@qq.com.""}, {'ForeName': 'Bingxia', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.""}, {'ForeName': 'Xueqin', 'Initials': 'X', 'LastName': 'Shan', 'Affiliation': ""Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.""}, {'ForeName': 'Yunyun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Cao', 'Affiliation': ""Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.""}, {'ForeName': 'Qingcheng', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': ""Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Geng', 'Affiliation': ""Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Emergency Department, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, 100730, China. xujunfree@126.com.'}]","Critical care (London, England)",['10.1186/s13054-020-03214-9']
1839,32763217,"Simplified dolutegravir dosing for children with HIV weighing 20 kg or more: pharmacokinetic and safety substudies of the multicentre, randomised ODYSSEY trial.","BACKGROUND


Paediatric dolutegravir doses approved by stringent regulatory authorities (SRAs) for children weighing 20 kg to less than 40 kg until recently required 25 mg and 10 mg film-coated tablets. These tablets are not readily available in low-resource settings where the burden of HIV is highest. We did nested pharmacokinetic substudies in patients enrolled in the ODYSSEY-trial to evaluate simplified dosing in children with HIV.
METHODS


We did pharmacokinetic and safety substudies within the open-label, multicentre, randomised ODYSSEY trial (NCT02259127) of children with HIV starting treatment in four research centres in Uganda and Zimbabwe. Eligible children were randomised to dolutegravir in ODYSSEY and weighed 20 kg to less than 40 kg. In children weighing 20 kg to less than 25 kg, we assessed dolutegravir's pharmacokinetics in children given once daily 25 mg film-coated tablets (approved by the SRAs at the time of the study) in part one of the study, and 50 mg film-coated tablets (adult dose) or 30 mg dispersible tablets in part two of the study. In children weighing 25 kg to less than 40 kg, we also assessed dolutegravir pharmacokinetics within-subject on film-coated tablet doses of 25 mg or 35 mg once daily, which were approved by the SRAs for the children's weight band; then switched to 50 mg film-coated tablets once daily. Steady-state 24 h dolutegravir plasma concentration-time pharmacokinetic profiling was done in all enrolled children at baseline and 1, 2, 3, 4, 6, and 24 h after observed dolutegravir intake. Target dolutegravir trough concentrations (C trough ) were based on reference adult pharmacokinetic data and safety was evaluated in all children in the corresponding weight bands who consented to pharmacokinetic studies and received the studied doses.
FINDINGS


Between Sept 22, 2016, and May 31, 2018, we enrolled 62 black-African children aged from 6 years to younger than 18 years (84 pharmacokinetic-profiles). In children weighing 20 kg to less than 25 kg taking 25 mg film-coated tablets, the geometric mean (GM) C trough  (coefficient of variation) was 0·32 mg/L (94%), which was 61% lower than the GM C trough  of 0·83 mg/L (26%) in fasted adults on dolutegravir 50 mg once-daily; in children weighing 25 kg to less than 30 kg taking 25 mg film-coated tablets, the GM C trough  was 0·39 mg/L (48%), which was 54% lower than the GM C trough  in fasted adults; and in those 30 kg to less than 40 kg taking 35 mg film-coated tablets the GM C trough  was 0·46 mg/L (63%), which was 45% lower than the GM C trough  in fasted adults. On 50 mg film-coated tablets or 30 mg dispersible tablets, C trough  was close to the adult reference (with similar estimates on the two formulations in children in the 20 to <25 kg weight band), with total exposure (area under the concentration-time curve from 0 h to 24 h) in between reference values in adults dosed once and twice daily, where safety data are reassuring, although maximum concentrations were higher in children weighing 20 kg to less than 25 kg than in the twice-daily adult reference. Over a 24-week follow-up period in 47 children on 30 mg dispersible tablets or 50 mg film-coated tablets, none of the three reported adverse events (cryptococcal meningitis, asymptomatic anaemia, and asymptomatic neutropenia) were considered related to dolutegravir.
INTERPRETATION


Adult dolutegravir 50 mg film-coated tablets given once daily provide appropriate pharmacokinetic profiles in children weighing 20 kg or more, with no safety signal, allowing simplified practical dosing and rapid access to dolutegravir. These results informed the WHO 2019 dolutegravir paediatric dosing guidelines and have led to US Food and Drug Administration approval of adult dosing down to 20 kg.
FUNDING


Paediatric European Network for Treatment of AIDS Foundation, ViiV Healthcare, UK Medical Research Council.",2020,"In children weighing 20 kg to less than 25 kg taking 25 mg film-coated tablets, the geometric mean (GM) C trough  (coefficient of variation) was 0·32","['62 black-African children aged from 6 years to younger than 18 years (84 pharmacokinetic-profiles', 'children with HIV weighing 20 kg or more', '47 children', 'Between Sept 22, 2016, and May 31, 2018', 'patients enrolled in the ODYSSEY-trial to evaluate simplified dosing in children with HIV', 'Eligible children', 'children with HIV starting treatment in four research centres in Uganda and Zimbabwe']",[],"[""dolutegravir's pharmacokinetics"", 'dolutegravir pharmacokinetics', 'adverse events (cryptococcal meningitis, asymptomatic anaemia, and asymptomatic neutropenia']","[{'cui': 'C0337824', 'cui_str': 'Black African'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0043476', 'cui_str': 'Zimbabwe'}]",[],"[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0085436', 'cui_str': 'Cryptococcal meningitis'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",62.0,0.226703,"In children weighing 20 kg to less than 25 kg taking 25 mg film-coated tablets, the geometric mean (GM) C trough  (coefficient of variation) was 0·32","[{'ForeName': 'Pauline D J', 'Initials': 'PDJ', 'LastName': 'Bollen', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, Netherlands.'}, {'ForeName': 'Cecilia L', 'Initials': 'CL', 'LastName': 'Moore', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Hilda A', 'Initials': 'HA', 'LastName': 'Mujuru', 'Affiliation': 'University of Zimbabwe Clinical Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Shafic', 'Initials': 'S', 'LastName': 'Makumbi', 'Affiliation': 'Joint Clinical Research Centre, Mbarara, Uganda.'}, {'ForeName': 'Adeodata R', 'Initials': 'AR', 'LastName': 'Kekitiinwa', 'Affiliation': ""Baylor College of Medicine Children's Foundation, Kampala, Uganda.""}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Kaudha', 'Affiliation': 'Joint Clinical Research Centre, Kampala, Uganda.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Parker', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Godfrey', 'Initials': 'G', 'LastName': 'Musoro', 'Affiliation': 'University of Zimbabwe Clinical Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Annet', 'Initials': 'A', 'LastName': 'Nanduudu', 'Affiliation': 'Joint Clinical Research Centre, Kampala, Uganda.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Lugemwa', 'Affiliation': 'Joint Clinical Research Centre, Mbarara, Uganda.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Amuge', 'Affiliation': ""Baylor College of Medicine Children's Foundation, Kampala, Uganda.""}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Hakim', 'Affiliation': 'University of Zimbabwe Clinical Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Rojo', 'Affiliation': 'Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Giaquinto', 'Affiliation': 'University of Padova, Padova, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Colbers', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, Netherlands. Electronic address: angela.colbers@radboudumc.nl.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Gibb', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Ford', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Turkova', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Burger', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(20)30189-2']
1840,32763218,Rapid antiretroviral therapy initiation in the Botswana Combination Prevention Project: a quasi-experimental before and after study.,"BACKGROUND


Ensuring that individuals who are living with HIV rapidly initiate antiretroviral therapy (ART) is an essential step in meeting the 90-90-90 targets. We evaluated the feasibility and outcomes of rapid ART initiation in the Botswana Combination Prevention Project (BCPP). We aimed to establish whether simplified ART initiation with the offer of same-day treatment could increase uptake and reduce time from clinic linkage to treatment initiation, while maintaining rates of retention in care and viral suppression.
METHODS


We did a quasi-experimental before and after study with use of data from the BCPP. The BCPP was a community-randomised HIV-prevention trial done in 30 communities across Botswana from Oct 1, 2013, to June 30, 2018. Participants in the 15 intervention clusters, who were HIV-positive and not already taking ART were offered universal HIV-treatment and same-day ART with a dolutegravir-based regimen at first clinic visit. This rapid ART intervention was implemented mid-way through the trial on June 1, 2016, enabling us to determine the effect of rapid ART guidelines on time to ART initiation and rates of retention in care and viral suppression at 1 year in the BCPP intervention group.
FINDINGS


We assessed 1717 adults linked to study clinics before rapid ART introduction and 800 after rapid ART introduction. During the rapid ART period, 457 (57·1%, 95% CI 53·7-60·6) individuals initiated ART within 1 day of linkage, 589 (73·7%, 70·6-76·7) of 799 within 1 week, 678 (84·9%, 82·4-87·3) of 799 within 1 month, and 744 (93·5%, 91·6-95·1) of 796 within 1 year. Before the introduction of rapid ART, 163 (9·5%, 95% CI 8·2-11·0) individuals initiated ART within 1 day of linkage, 276 (16·1%, 14·4-17·9) within 1 week, 839 (48·9%, 46·5-51·3) within 1 month, and 1532 (89·2%, 87·7-90·6) within 1 year. 1 year after ART initiation, 1472 (90·5%, 87·4-92·8) of 1627 individuals who linked in the standard ART period were in care and had a viral load of less than 400 copies per mL, compared with 578 (91·6%, 88·1-94·1) of 631 in the rapid ART period (risk ratio 1·01, 95% CI 0·92-1·11).
INTERPRETATION


Our findings provide support for the WHO recommendations for rapid ART initiation, and add to the accumulating evidence showing the feasibility, acceptability, and safety of rapid ART initiation in low-income and middle-income country settings.
FUNDING


US President's Emergency Plan for AIDS Relief.",2020,"1 year after ART initiation, 1472 (90·5%, 87·4-92·8) of 1627 individuals who linked in the standard ART period were in care and had a viral load of less than 400 copies per mL, compared with 578 (91·6%, 88·1-94·1) of 631 in the rapid ART period (risk ratio 1·01, 95% CI 0·92-1·11).
","['30 communities across Botswana from Oct 1, 2013, to June 30, 2018', 'individuals who are living with HIV rapidly initiate antiretroviral therapy (ART', '1717 adults linked to study clinics before rapid ART introduction and 800 after rapid ART introduction', 'Participants in the 15 intervention clusters, who were HIV-positive and not already taking ART were offered universal HIV-treatment and same-day ART with a dolutegravir-based regimen at first clinic visit']",[],['time to ART initiation and rates of retention in care and viral suppression'],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0006041', 'cui_str': 'Botswana'}, {'cui': 'C1442824', 'cui_str': 'POU2F1 protein, human'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C4704685', 'cui_str': 'Care Retention'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",1717.0,0.242917,"1 year after ART initiation, 1472 (90·5%, 87·4-92·8) of 1627 individuals who linked in the standard ART period were in care and had a viral load of less than 400 copies per mL, compared with 578 (91·6%, 88·1-94·1) of 631 in the rapid ART period (risk ratio 1·01, 95% CI 0·92-1·11).
","[{'ForeName': 'Refeletswe', 'Initials': 'R', 'LastName': 'Lebelonyane', 'Affiliation': 'Botswana Ministry of Health and Wellness, Gaborone, Botswana.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Bachanas', 'Affiliation': 'Centers for Disease Control and Prevention, Division of Global HIV/AIDS and TB, Atlanta, GA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Block', 'Affiliation': 'Northrop Grumman, Atlanta, GA, USA.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Ussery', 'Affiliation': 'Centers for Disease Control and Prevention, Division of Global HIV/AIDS and TB, Atlanta, GA, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Abrams', 'Affiliation': 'Centers for Disease Control and Prevention, Gaborone, Botswana.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Roland', 'Affiliation': 'Centers for Disease Control and Prevention, Gaborone, Botswana.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Theu', 'Affiliation': 'Botswana Ministry of Health and Wellness, Gaborone, Botswana.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Kapanda', 'Affiliation': 'Botswana Ministry of Health and Wellness, Gaborone, Botswana.'}, {'ForeName': 'Stembile', 'Initials': 'S', 'LastName': 'Matambo', 'Affiliation': 'Botswana Ministry of Health and Wellness, Gaborone, Botswana.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Lockman', 'Affiliation': ""Harvard T H Chan School of Public Health, Boston, MA, USA; Brigham and Women's Hospital, Boston, MA, USA; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.""}, {'ForeName': 'Tendani', 'Initials': 'T', 'LastName': 'Gaolathe', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana; University of Botswana School of Medicine, Gaborone, Botswana.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Makhema', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'Centers for Disease Control and Prevention, Division of Global HIV/AIDS and TB, Atlanta, GA, USA.'}, {'ForeName': 'Joseph N', 'Initials': 'JN', 'LastName': 'Jarvis', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana; Botswana-University of Pennsylvania Partnership, Gaborone, Botswana; Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK. Electronic address: joseph.jarvis@lshtm.ac.uk.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30187-9']
1841,32763234,Comparison of intermittent versus continuous-infusion vancomycin for treating severe patients in intensive care units.,"PURPOSE


The aim of this study was to compare pharmacokinetic characteristics between intermittent infusion and continuous infusion of vancomycin for critically ill patients admitted to intensive care units.
METHODS


Intermittent therapy was administered for 60minutes and prescribed as a loading dose of 30mg/kg and continued with 15mg/kg q12h. Continuous infusion was prescribed as a loading dose of 30mg/kg followed by 30mg/kg on constant infusion pump. Blood samples from vancomycin intermittent infusion group were collected 1h before third dose, 1h, 8h and 24h after third dose infusion. Blood samples from vancomycin continuous infusion group were collected 1h after loading dose, 12h, 24h, 36h, and 48h after continuous infusion initiation.
RESULTS


Median serum concentration of continuous infusion group at 24-hour was 23.59μg/mL [14.52-28.97], while of intermittent infusion group at 23-hour was 12.30μg/mL [7.27-18.12] and on 25-hour was 17.58μg/mL [12.5-22.5]. Medians AUC 24-48h  were 357.2mg.h/L and 530.2mg.h/L for intermittent infusion and continuous infusion groups, respectively (p=0.559).
CONCLUSION


Vancomycin CI reached steady state earlier, which guaranteed therapeutic levels from the first day and made it possible to manage therapeutic drug monitoring faster.",2020,"AUC 24-48h  were 357.2mg.h/L and 530.2mg.h/L for II and CI groups, respectively (p=0.559).
","['critically ill patients admitted to intensive care units', 'severe patients in intensive care units']","['vancomycin CI', 'vancomycin', 'intermittent versus continuous-infusion vancomycin', 'intermittent infusion (II) and continuous infusion (CI) of vancomycin', 'Vancomycin CI']","['pharmacokinetic characteristics', 'Median serum concentration']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0813945,"AUC 24-48h  were 357.2mg.h/L and 530.2mg.h/L for II and CI groups, respectively (p=0.559).
","[{'ForeName': 'Carolina Hikari', 'Initials': 'CH', 'LastName': 'Yamada', 'Affiliation': 'Pontifícia Universidade Católica do Paraná, Faculdade de Medicina, Curitiba, Paraná, PR, Brazil.'}, {'ForeName': 'João Paulo', 'Initials': 'JP', 'LastName': 'Telles', 'Affiliation': 'AC Camargo Cancer Center, São Paulo, SP, Brazil; Hospital Universitário Cajuru, Curitiba, Paraná, PR, Brazil; Pontifícia Universidade Católica do Paraná, Faculdade de Medicina, Laboratório de Doenças Infeccionas Emergentes, Curitiba, PR, Brazil.'}, {'ForeName': 'Dayana Dos Santos', 'Initials': 'DDS', 'LastName': 'Oliveira', 'Affiliation': 'Hospital Universitário Cajuru, Curitiba, Paraná, PR, Brazil.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Cieslinski', 'Affiliation': 'Pontifícia Universidade Católica do Paraná, Faculdade de Medicina, Curitiba, Paraná, PR, Brazil; Pontifícia Universidade Católica do Paraná, Faculdade de Medicina, Laboratório de Doenças Infeccionas Emergentes, Curitiba, PR, Brazil.'}, {'ForeName': 'Victoria Stadler Tasca', 'Initials': 'VST', 'LastName': 'Ribeiro', 'Affiliation': 'Pontifícia Universidade Católica do Paraná, Faculdade de Medicina, Curitiba, Paraná, PR, Brazil; Pontifícia Universidade Católica do Paraná, Faculdade de Medicina, Laboratório de Doenças Infeccionas Emergentes, Curitiba, PR, Brazil.'}, {'ForeName': 'Juliano', 'Initials': 'J', 'LastName': 'Gasparetto', 'Affiliation': 'Pontifícia Universidade Católica do Paraná, Faculdade de Medicina, Curitiba, Paraná, PR, Brazil; Hospital Universitário Cajuru, Curitiba, Paraná, PR, Brazil.'}, {'ForeName': 'Felipe Francisco', 'Initials': 'FF', 'LastName': 'Tuon', 'Affiliation': 'Pontifícia Universidade Católica do Paraná, Faculdade de Medicina, Curitiba, Paraná, PR, Brazil; Hospital Universitário Cajuru, Curitiba, Paraná, PR, Brazil; Pontifícia Universidade Católica do Paraná, Faculdade de Medicina, Laboratório de Doenças Infeccionas Emergentes, Curitiba, PR, Brazil. Electronic address: felipe.tuon@pucpr.br.'}]",The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases,['10.1016/j.bjid.2020.07.001']
1842,32763240,"A Phase 1b safety study of SER-287, a spore-based microbiome therapeutic, for active mild to moderate ulcerative colitis.","BACKGROUND & AIMS


Firmicutes bacteria produce metabolites that maintain the intestinal barrier and mucosal immunity. Firmicutes are reduced in the intestinal microbiota of patients with ulcerative colitis (UC). In a phase 1b trial of patients with UC, we evaluated the safety and efficacy of SER-287, an oral formulation of Firmicutes spores, and the effects of vancomycin preconditioning on expansion (engraftment) of SER-287 species in the colon.
METHODS


We conducted a double-blind trial of SER-287 in 58 adults with active mild-to-moderate UC (modified Mayo scores 4-10, endoscopic subscores ≥1). Participants received 6 days of preconditioning with oral vancomycin (125 mg, 4 times daily) or placebo followed by 8 weeks of oral SER-287 or placebo. Patients were randomly assigned (2:3:3:3) to groups that received placebo followed by either placebo or SER-287 once weekly, or vancomycin followed by SER-287 once weekly or SER-287 once daily. Clinical endpoints included safety and clinical remission (modified Mayo score ≤ 2; endoscopic subscores 0 or 1). Microbiome endpoints included SER-287 engraftment (dose species detected in stool after, but not before, SER-287 administration). Engraftment of SER-287 and changes in microbiome composition and associated metabolites were measured by analyses of stool specimens collected at baseline, after preconditioning, and during and 4 weeks after administration of SER-287 or placebo.
RESULTS


Proportions of patients with adverse events did not differ significantly among groups. A higher proportion of patients in the vancomycin/SER-287 daily group (40%) achieved clinical remission at week 8 than patients in the placebo/placebo group (0), placebo/SER-287 weekly group (13.3%), or vancomycin/SER-287 weekly group (17.7%) (P=.024 for vancomycin/SER-287 daily vs placebo/placebo). By day 7, higher numbers of SER-287 dose species were detected in stool samples from all SER-287 groups compared with the placebo group (P<.05), but this difference was not maintained beyond day 7 in the placebo/SER-287 weekly group. In the vancomycin groups, a greater number of dose species were detected in stool collected on day 10 and all subsequent time points, through 4 weeks post-dosing, compared with the placebo group (P<.05). A higher number of SER-287 dose species were detected in stool samples on days 7 and 10 from subjects who received daily vs weekly SER-287 doses (P<.05). Changes in fecal microbiome composition and metabolites were associated with both vancomycin/SER-287 groups.
CONCLUSIONS


In this small phase 1b trial of limited duration, the safety and tolerability of SER-287 were similar to placebo. SER-287 following vancomycin was significantly more effective than placebo for induction of remission in patients with active mild-to-moderate UC. Engraftment of dose species was facilitated by vancomycin preconditioning and daily dosing of SER-287.",2020,"By day 7, higher numbers of SER-287 dose species were detected in stool samples from all SER-287 groups compared with the placebo group (P<.05), but this difference was not maintained beyond day 7 in the placebo/SER-287 weekly group.","['patients with active mild-to-moderate UC', '58 adults with active mild-to-moderate UC (modified Mayo scores 4-10, endoscopic subscores ≥1', 'active mild to moderate ulcerative colitis', 'patients with ulcerative colitis (UC', 'patients with UC']","['placebo or SER-287', 'vancomycin', 'oral SER-287 or placebo', 'placebo/placebo', 'vancomycin/SER-287 daily vs placebo/placebo', 'preconditioning with oral vancomycin', 'vancomycin followed by SER-287 once weekly or SER-287 once daily', 'placebo/SER-287', 'vancomycin/SER-287', 'vancomycin preconditioning', 'vancomycin preconditioning and daily dosing of SER-287', 'SER-287', 'placebo']","['numbers of SER-287 dose species', 'safety and efficacy of SER-287', 'safety and clinical remission (modified Mayo score ≤ 2; endoscopic subscores 0 or 1', 'microbiome composition and associated metabolites', 'intestinal microbiota', 'SER-287 engraftment', 'number of dose species', 'safety and tolerability of SER-287', 'fecal microbiome composition and metabolites', 'adverse events', 'clinical remission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036720', 'cui_str': 'Serine'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1709632', 'cui_str': 'Precondition'}, {'cui': 'C0360373', 'cui_str': 'Vancomycin-containing product in oral dose form'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0036720', 'cui_str': 'Serine'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",58.0,0.414313,"By day 7, higher numbers of SER-287 dose species were detected in stool samples from all SER-287 groups compared with the placebo group (P<.05), but this difference was not maintained beyond day 7 in the placebo/SER-287 weekly group.","[{'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Henn', 'Affiliation': ''}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': ""O'Brien"", 'Affiliation': ''}, {'ForeName': 'Liyang', 'Initials': 'L', 'LastName': 'Diao', 'Affiliation': ''}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': ''}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': ''}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Huttenhower', 'Affiliation': ''}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Wortman', 'Affiliation': ''}, {'ForeName': 'Barbara H', 'Initials': 'BH', 'LastName': 'McGovern', 'Affiliation': ''}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Wang-Weigand', 'Affiliation': ''}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Lichter', 'Affiliation': ''}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Chafee', 'Affiliation': ''}, {'ForeName': 'Chris B', 'Initials': 'CB', 'LastName': 'Ford', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Bernardo', 'Affiliation': ''}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Sheri', 'Initials': 'S', 'LastName': 'Simmons', 'Affiliation': ''}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Tomlinson', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cook', 'Affiliation': ''}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Pomerantz', 'Affiliation': ''}, {'ForeName': 'Bharat K', 'Initials': 'BK', 'LastName': 'Misra', 'Affiliation': ''}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Auninš', 'Affiliation': ''}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Trucksis', 'Affiliation': ''}]",Gastroenterology,['10.1053/j.gastro.2020.07.048']
1843,32763967,Value of FEops HEARTguide patient-specific computational simulations in the planning of left atrial appendage closure with the Amplatzer Amulet closure device: rationale and design of the PREDICT-LAA study.,"BACKGROUND


Optimal preprocedural planning is essential to ensure successful device closure of the left atrial appendage (LAA).
DESIGN


The PREDICT-LAA study is a prospective, international, multicentre, randomised controlled trial (ClinicalTrials.gov NCT04180605). Two hundred patients eligible for LAA closure with an Amplatzer Amulet device (Abbott, USA) will be enrolled in the study. Patients will be allocated to a computational simulation arm (experimental) or standard treatment arm (control) using a 1:1 randomisation. For patients randomised to the computational simulation arm, preprocedural planning will be based on the analysis of cardiac computed tomography (CCT)-based patient-specific computational simulations (FEops HEARTguide, Ghent, Belgium) in order to predict optimal device size and position. For patients in the control arm, preprocedural planning will be based on local practice including CCT analysis. The LAA closure procedure and postprocedural antithrombotic therapy will follow local practice in both arms. The primary endpoint of the study is incomplete LAA closure and device-related thrombus as assessed at 3 months postprocedural CCT. Secondary endpoints encompass procedural efficiency (number of devices used, number of repositioning, procedural time, radiation exposure, contrast dye), procedure-related complications within 7 days postprocedure and a composite of all-cause death and thromboembolic events at 12 months.
CONCLUSION


The objective of the PREDICT-LAA study is to test the hypothesis that a preprocedural planning for LAA closure with the Amplatzer Amulet device based on patient-specific computational simulations can result in a more efficient procedure, optimised procedural outcomes and better clinical outcomes as compared with a standard preprocedural planning.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT04180605).",2020,"Secondary endpoints encompass procedural efficiency (number of devices used, number of repositioning, procedural time, radiation exposure, contrast dye), procedure-related complications within 7 days postprocedure and a composite of all-cause death and thromboembolic events at 12 months.
","['Two hundred patients eligible for LAA closure with an Amplatzer Amulet device (Abbott, USA']",['computational simulation arm (experimental) or standard treatment arm (control'],"['incomplete LAA closure and device-related thrombus as assessed at 3 months postprocedural CCT', 'procedural efficiency (number of devices used, number of repositioning, procedural time, radiation exposure, contrast dye), procedure-related complications within 7 days postprocedure and a composite of all-cause death and thromboembolic events']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4523927', 'cui_str': 'Atrial appendage closure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C4523927', 'cui_str': 'Atrial appendage closure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1298904', 'cui_str': 'Device used'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}]",200.0,0.183072,"Secondary endpoints encompass procedural efficiency (number of devices used, number of repositioning, procedural time, radiation exposure, contrast dye), procedure-related complications within 7 days postprocedure and a composite of all-cause death and thromboembolic events at 12 months.
","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Garot', 'Affiliation': 'Department of Cardiology, Institut Cardiovasculaire Paris Sud, Massy, Île-de-France, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Iriart', 'Affiliation': 'Pediatric and Congenital Cardiology, University Hospital of Bordeaux, Pessac, MS, France.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Aminian', 'Affiliation': 'Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Hainaut, Belgium.'}, {'ForeName': 'Joelle', 'Initials': 'J', 'LastName': 'Kefer', 'Affiliation': 'Division of Cardiology, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Freixa', 'Affiliation': 'Cardiovascular Institute, Hospital Clinic de Barcelona, Barcelona, Catalunya, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Cruz-Gonzalez', 'Affiliation': 'Department of Cardiology, Hospital Clínico Universitario de Salamanca, Salamanca, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Berti', 'Affiliation': 'Cardiology Unit, Fondazione CNR Regione Toscana, Massa, Italy.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Rosseel', 'Affiliation': 'Department of Cardiology, University Hospital Galway, Galway, Ireland.'}, {'ForeName': 'Reda', 'Initials': 'R', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Cardiology, Montreal Heart Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Korsholm', 'Affiliation': 'Department of Cardiology, Aarhus Universitetshospital Skejby, Aarhus, Denmark.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Odenstedt', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Goteborg, Sweden.'}, {'ForeName': 'Jens-Erik', 'Initials': 'JE', 'LastName': 'Nielsen-Kudsk', 'Affiliation': 'Department of Cardiology, Aarhus Universitetshospital Skejby, Aarhus, Denmark.'}, {'ForeName': 'Jaqueline', 'Initials': 'J', 'LastName': 'Saw', 'Affiliation': 'Department of Cardiology, Vancouver General Hospital, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Sondergaard', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'De Backer', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark ole.debacker@gmail.com.'}]",Open heart,['10.1136/openhrt-2020-001326']
1844,32764081,"Acupuncture for acute non-specific low back pain: a randomised, controlled, multicentre intervention study in general practice-the Acuback study.","OBJECTIVES


The aim of this study was to evaluate whether a single treatment session of acupuncture, when applied in addition to standard treatment for acute low back pain (ALBP), reduces the time to recovery compared with standard treatment alone.
DESIGN


A multicentre, randomised, controlled trial.
SETTING


Conducted at 11 Norwegian general practitioners' (GPs') offices.
PARTICIPANTS


171 adults aged 20-55 years seeking their GP for ALBP (≤14 days) between March 2014 and March 2017. Patients with secondary back pain and previous sick leave and acupuncture treatment was excluded.
INTERVENTIONS


The participants were randomised to either the control group (CG) or the acupuncture group (AG) by online software. The CG received standard treatment according to the Norwegian guidelines, while the AG received one session of Western medical acupuncture treatment in addition to standard treatment. The statistician was blinded to group status.
PRIMARY AND SECONDARY OUTCOME MEASURES


The primary outcome was median days to recovery. Secondary outcomes were pain intensity, global improvement, back-specific functional status, sick leave, medication and adverse effects.
RESULTS


185 participants were randomised, 95 in the CG and 90 in the AG. 14 participants did not receive the allocated intervention and 4 were excluded from the analysis. Thus, 167 participants were included in the analysis, 86 in the CG and 81 in the AG. The groups were similar according to baseline characteristics. The median time to recovery was 14 days for the CG and 9 days for the AG, HR 1.37 (95% CI 0.95 to 1.96), (p=0.089). No serious adverse effects were reported.
CONCLUSIONS


We did not find any statistically significant reduction in time-to-recovery after a single session of acupuncture for ALBP compared with standard care.
TRIAL REGISTRATION NUMBER


NCT01439412.",2020,"We did not find any statistically significant reduction in time-to-recovery after a single session of acupuncture for ALBP compared with standard care.
","['Patients with secondary back pain and previous sick leave and acupuncture treatment was excluded', '171 adults aged 20-55 years seeking their GP for ALBP (≤14 days) between March 2014 and March 2017', ""Conducted at 11 Norwegian general practitioners' (GPs') offices"", '14 participants did not receive the allocated intervention and 4 were excluded from the analysis', 'acute low back pain (ALBP', '167 participants were included in the analysis, 86 in the CG and 81 in the AG', 'acute non-specific low back pain', '185 participants were randomised, 95 in the CG and 90 in the AG']","['acupuncture', 'Acupuncture', 'control group (CG) or the acupuncture group (AG) by online software']","['median days to recovery', 'time-to-recovery', 'pain intensity, global improvement, back-specific functional status, sick leave, medication and adverse effects', 'median time to recovery', 'serious adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0457950', 'cui_str': 'Acute low back pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C4517617', 'cui_str': '185'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",167.0,0.197259,"We did not find any statistically significant reduction in time-to-recovery after a single session of acupuncture for ALBP compared with standard care.
","[{'ForeName': 'Trygve', 'Initials': 'T', 'LastName': 'Skonnord', 'Affiliation': 'Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway trygve.skonnord@medisin.uio.no.'}, {'ForeName': 'Holgeir', 'Initials': 'H', 'LastName': 'Skjeie', 'Affiliation': 'Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Brekke', 'Affiliation': 'General Practice Research Unit (AFE), Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Atle', 'Initials': 'A', 'LastName': 'Klovning', 'Affiliation': 'Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Margreth', 'Initials': 'M', 'LastName': 'Grotle', 'Affiliation': 'Department of Physiotherapy, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Aas', 'Affiliation': 'Department of Health Management and Health Economics, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Ibrahimu', 'Initials': 'I', 'LastName': 'Mdala', 'Affiliation': 'General Practice Research Unit (AFE), Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Fetveit', 'Affiliation': 'General Practice Research Unit (AFE), Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}]",BMJ open,['10.1136/bmjopen-2019-034157']
1845,32764089,Study protocol for a cluster randomised controlled trial testing the effectiveness of the 'High schools High on life' intervention on reducing excessive drinking in Danish high schools.,"INTRODUCTION


This paper describes the evaluation design of the 'High schools High on life' intervention; a school-based intervention to reduce excessive drinking among high school students in Denmark. The intervention includes a school environmental component to limit access to alcohol at school, a school-educational component to change social norms around alcohol among first year students and a parental component addressing parents' knowledge and attitudes towards alcohol.
METHODS AND DESIGN


The study will employ a cluster randomised controlled study design and will include a random sample of 16 high schools randomly allocated 1:1 to either intervention or control group. Target group: first year high school students. Timeline: baseline survey: January to March 2019, collected as part of the Danish National Youth Study 2019. Delivery of intervention: April 2019 to March 2020. Follow-up survey: April to May 2020.
PRIMARY OUTCOME MEASURE


30% reduction in mean number of binge-drinking episodes (five or more alcoholic drinks on one occasion) within the last 30 days.
SECONDARY OUTCOME MEASURES


proportion of students who drink alcohol, mean weekly alcohol consumption, alcohol intake at last school party, alcohol intake at the school during last school party, proportion of students who agree to be able to have fun at a party without drinking and the proportion of students who think alcohol plays a too dominant part at the school. Implementation will be monitored through process evaluation.
ETHICS AND DISSEMINATION


The Scientific Ethics Committees for the Capital Region of Denmark has declared that the trial is not subject to notification (jnr. 19021957). The study is registered at the Research an Innovation Office at University of Southern Denmark (ref: 10.314) allowing collection of personal data. Results will be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT03906500.",2020,The Scientific Ethics Committees for the Capital Region of Denmark has declared that the trial is not subject to notification (jnr.,"['Danish high schools', 'Target group: first year high school students', 'Timeline: baseline survey: January to March 2019, collected as part of the Danish National Youth Study 2019', 'random sample of 16 high schools', 'high school students in Denmark']","[""school environmental component to limit access to alcohol at school, a school-educational component to change social norms around alcohol among first year students and a parental component addressing parents' knowledge and attitudes towards alcohol"", ""High schools High on life' intervention"", 'school-based intervention']","['proportion of students who drink alcohol, mean weekly alcohol consumption, alcohol intake at last school party, alcohol intake', 'mean number of binge-drinking episodes ']","[{'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",16.0,0.0307791,The Scientific Ethics Committees for the Capital Region of Denmark has declared that the trial is not subject to notification (jnr.,"[{'ForeName': 'Veronica Sofie Clara', 'Initials': 'VSC', 'LastName': 'Pisinger', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Syddanmark, Denmark vepi@sdu.dk.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Hoffmann', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Syddanmark, Denmark.'}, {'ForeName': 'Johanne Aviaja', 'Initials': 'JA', 'LastName': 'Rosing', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Syddanmark, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Grønbæk', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Syddanmark, Denmark.'}, {'ForeName': 'Janne Schurmann', 'Initials': 'JS', 'LastName': 'Tolstrup', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Syddanmark, Denmark.'}, {'ForeName': 'Lau', 'Initials': 'L', 'LastName': 'Thygesen', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Syddanmark, Denmark.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Krølner', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Syddanmark, Denmark.'}]",BMJ open,['10.1136/bmjopen-2020-038857']
1846,32764219,"Comparisons of Within-Group Instead of Between-Group Affect the Conclusions. Comment on: ""Changes in Weight and Substrate Oxidation in Overweight Adults Following Isomaltulose Intake during a 12-Week Weight Loss Intervention: A Randomized, Double-Blind, Controlled Trial"".  Nutrients  2019,  11 (10), 2367.",We read with interest the publication by Lightowler et al [...].,2020,We read with interest the publication by Lightowler et al [...].,['Overweight Adults Following Isomaltulose Intake during a 12-Week Weight Loss Intervention'],[],['Weight and Substrate Oxidation'],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0064002', 'cui_str': 'isomaltulose'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}]",,0.320393,We read with interest the publication by Lightowler et al [...].,"[{'ForeName': 'Colby J', 'Initials': 'CJ', 'LastName': 'Vorland', 'Affiliation': 'Department of Applied Health Science, Indiana University School of Public Health-Bloomington, Bloomington, IN 47405, USA.'}, {'ForeName': 'Theodore K', 'Initials': 'TK', 'LastName': 'Kyle', 'Affiliation': 'ConscienHealth, Pittsburgh, PA 15241, USA.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Brown', 'Affiliation': 'Department of Applied Health Science, Indiana University School of Public Health-Bloomington, Bloomington, IN 47405, USA.'}]",Nutrients,['10.3390/nu12082335']
1847,32764258,"Reply to ""Comparisons of Within-Group Instead of Between-Group Affect the Conclusions. Comment on: Changes in Weight and Substrate Oxidation in Overweight Adults Following Isomaltulose Intake during a 12-Week Weight Loss Intervention: A Randomized, Double-Blind, Controlled Trial.  Nutrients  2019,  11 (10), 2367"".","We thank the authors Vorland, Kyle and Brown for their interest in our paper and their comments [...].",2020,"We thank the authors Vorland, Kyle and Brown for their interest in our paper and their comments [...].",['Overweight Adults Following Isomaltulose Intake during a 12-Week Weight Loss Intervention'],[],['Weight and Substrate Oxidation'],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0064002', 'cui_str': 'isomaltulose'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}]",,0.215808,"We thank the authors Vorland, Kyle and Brown for their interest in our paper and their comments [...].","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Lightowler', 'Affiliation': 'Oxford Brookes Centre for Nutrition and Health, Department of Sport, Health Sciences and Social Work, Faculty of Health and Life Sciences, Oxford Brookes University, Headington Campus, Gipsy Lane, Oxford OX3 0BP, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Schweitzer', 'Affiliation': 'BENEO-Institute, BENEO GmbH, Wormser Straße 11, 67283 Obrigheim/Pfalz, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Theis', 'Affiliation': 'BENEO-Institute, BENEO GmbH, Wormser Straße 11, 67283 Obrigheim/Pfalz, Germany.'}, {'ForeName': 'Christiani Jeyakumar', 'Initials': 'CJ', 'LastName': 'Henry', 'Affiliation': 'Clinical Nutrition Research Centre (CNRC), Singapore Institute for Clinical Sciences (SICS), Agency for Science, Technology and Research (A*STAR) and National University Health System, Centre for Translational Medicine, 14 Medical Drive #07-02, MD 6 Building, Yong Loo Lin School of Medicine, Singapore 117599, Singapore.'}]",Nutrients,['10.3390/nu12082339']
1848,32764261,The Impact of the Timing of Health-Related Quality of Life Assessments on the Actual Results in Glioma Patients: A Randomized Prospective Study.,"BACKGROUND


The aim of this study was to explore the impact of the timing of Health-Related Quality of Life (HRQoL) measurements in clinical care on the obtained HRQoL scores in glioma patients, and the association with feelings of anxiety or depression.
METHODS


Patients completed the European Organisation for Research and Treatment of Cancer (EORTC)'s Quality of Life Questionnaires (QLQ-C30 and QLQ-BN20), and the Hospital Anxiety and Depression Scale (HADS) twice. All patients completed the first measurement on the day of the Magnetic Resonance Imaging (MRI) scan ( t  = 0), but the second measurement ( t  = 1) depended on randomization; Group 1 ( n  = 49) completed the questionnaires before and Group 2 ( n  = 51) after the consultation with the physician.
RESULTS


median HRQoL scale scores on t0/t1 and change scores were comparable between the two groups. Between 8-58% of patients changed to a clinically relevant extent (i.e., ≥10 points) on the evaluated HRQoL scales in about one-week time, in both directions, with only 3% of patients remaining stable in all scales. Patients with a stable role functioning had a lower HADS anxiety change score. The HADS depression score was not associated with a change in HRQoL.
CONCLUSIONS


Measuring HRQoL before or after the consultation did not impact HRQoL scores on a group level. However, most patients reported a clinically relevant difference in at least one HRQoL scale between the two time points. These findings highlight the importance of standardized moments of HRQoL assessments, or patient-reported outcomes in general, during treatment and follow-up in clinical trials.",2020,"The HADS depression score was not associated with a change in HRQoL.
CONCLUSIONS


Measuring HRQoL before or after the consultation did not impact HRQoL scores on a group level.","['Patients completed the European Organisation for Research and Treatment of', 'Glioma Patients', 'glioma patients']",['Magnetic Resonance Imaging (MRI) scan'],"['evaluated HRQoL scales', 'HRQoL scale', 'HADS anxiety change score', 'HADS depression score', 'median HRQoL scale scores', ""Cancer (EORTC)'s Quality of Life Questionnaires (QLQ-C30 and QLQ-BN20), and the Hospital Anxiety and Depression Scale (HADS) twice""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1720725', 'cui_str': 'Twice'}]",,0.0694939,"The HADS depression score was not associated with a change in HRQoL.
CONCLUSIONS


Measuring HRQoL before or after the consultation did not impact HRQoL scores on a group level.","[{'ForeName': 'Marthe C M', 'Initials': 'MCM', 'LastName': 'Peeters', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, 2333 ZA Leiden, The Netherlands.'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Zwinkels', 'Affiliation': 'Department of Neurology, Haaglanden Medical Center, 2262 BA The Hague, The Netherlands.'}, {'ForeName': 'Johan A F', 'Initials': 'JAF', 'LastName': 'Koekkoek', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, 2333 ZA Leiden, The Netherlands.'}, {'ForeName': 'Maaike J', 'Initials': 'MJ', 'LastName': 'Vos', 'Affiliation': 'Department of Neurology, Haaglanden Medical Center, 2262 BA The Hague, The Netherlands.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Dirven', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, 2333 ZA Leiden, The Netherlands.'}, {'ForeName': 'Martin J B', 'Initials': 'MJB', 'LastName': 'Taphoorn', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, 2333 ZA Leiden, The Netherlands.'}]",Cancers,['10.3390/cancers12082172']
1849,32764397,Effects of High Intensity Dynamic Resistance Exercise and Whey Protein Supplements on Osteosarcopenia in Older Men with Low Bone and Muscle Mass. Final Results of the Randomized Controlled FrOST Study.,"The present study aimed to evaluate the effect of high intensity dynamic resistance exercise (HIT-DRT) and whey protein supplementation (WPS) on bone mineral density (BMD) and sarcopenia parameters in osteosarcopenic men. Men ≥ 72 years with osteosarcopenia ( n  = 43) were randomly assigned to a HIT-RT (HIT-RT:  n  = 21) or a non-training control group ( n  = 22). Supervised HIT-RT twice/week was applied for 18 months, while the control group maintained their habitual lifestyle. Supplying WPS, total protein intake amounted to 1.5-1.6 (HIT-RT) and 1.2 g/kg/body mass/d (control). Both groups were supplied with calcium and vitamin D. Primary study outcomes were BMD and the sarcopenia Z-score. After adjusting for multiplicity, we observed significant positive effects for sarcopenia Z-score (standardized mean difference (SMD): 1.40), BMD at lumbar spine (SMD: 0.72) and total hip (SMD: 0.72). In detail, effect sizes for skeletal muscle mass changes were very pronounced (1.97,  p  < 0.001), while effects for functional sarcopenia parameters were moderate (0.87,  p  = 0.008; handgrip strength) or low (0.39,  p  = 0.209; gait velocity). Apart from one man who reported short periods of temporary worsening of existing joint pain, no HIT-RT/WPS-related adverse effects or injuries were reported. We consider HIT-RT supported by whey protein supplementation as a feasible, attractive, safe and highly effective option to fight osteosarcopenia in older men.",2020,"In detail, effect sizes for skeletal muscle mass changes were very pronounced (1.97,  p  < 0.001), while effects for functional sarcopenia parameters were moderate (0.87,  p  = 0.008; handgrip strength) or low (0.39,  p  = 0.209; gait velocity).","['Men ≥ 72 years with osteosarcopenia ( n  = 43', 'older men', 'Older Men with Low Bone and Muscle Mass', 'osteosarcopenic men']","['HIT-RT (HIT-RT:  n  = 21) or a non-training control group', 'high intensity dynamic resistance exercise (HIT-DRT) and whey protein supplementation (WPS', 'High Intensity Dynamic Resistance Exercise and Whey Protein Supplements']","['Supplying WPS, total protein intake', 'BMD and the sarcopenia Z-score', 'sarcopenia Z-score', 'BMD at lumbar spine', 'bone mineral density (BMD) and sarcopenia parameters']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}]","[{'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",43.0,0.045492,"In detail, effect sizes for skeletal muscle mass changes were very pronounced (1.97,  p  < 0.001), while effects for functional sarcopenia parameters were moderate (0.87,  p  = 0.008; handgrip strength) or low (0.39,  p  = 0.209; gait velocity).","[{'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Kemmler', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg, Henkestrasse 91, 91053 Erlangen, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Kohl', 'Affiliation': 'Faculty Medical and Life Sciences, University of Furtwangen, Neckarstrasse 1, 78054 Villingen-Schwenningen, Germany.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Jakob', 'Affiliation': 'Bernhard-Heine-Center for Locomotion Research, University of Würzburg, Brettreichstrasse 11, 97074 Würzburg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Engelke', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg, Henkestrasse 91, 91053 Erlangen, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'von Stengel', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg, Henkestrasse 91, 91053 Erlangen, Germany.'}]",Nutrients,['10.3390/nu12082341']
1850,32772097,One-year efficacy and incremental cost-effectiveness of contingency management for cigarette smokers with depression.,"INTRODUCTION


Contingency management (CM) is efficacious for smoking cessation. To date, the number of cost-effectiveness evaluations of behavioral and pharmacological smoking cessation treatments far outnumbers the ones on CM. This study estimated one-year efficacy and incremental cost-effectiveness (ICE) of adding CM in relation to abstinence outcomes for a cognitive-behavioral therapy (CBT)+behavioral activation (BA) treatment.
METHODS


The study sample comprised 120 smokers with depression [% females: 70.8%; mean age: 51.67(SD = 9.59)] enrolled in an 8-week randomized controlled clinical trial. Clinical effectiveness variables were point prevalence abstinence, continuous abstinence, longest duration of abstinence (LDA), and Beck-Depression Inventory-II (BDI-II) scores at one-year follow-up. Cost-effectiveness analyses were based on resource utilization, unit costs per patient, and incremental cost per additional LDA week at one year.
RESULTS


There was a significant effect of time by treatment group interaction, which indicated superior effects of CBT+BA+CM across time. Point-prevalence abstinence [53.3% (32/60)] was superior in participants receiving CBT+BA+CM compared to those in CBT+BA [23.3% (14/60)], but both groups were equally likely to present sustained reductions in depression. The average cost per patient was €208.85(US$236.57) for CBT+BA and €410.64(US$465.14) for CBT+BA+CM, p<.001. The incremental cost of using CM to enhance one-year abstinence by one extra LDA week was 18€(US$20.39) [95%CI: 17.75-18.25].
CONCLUSIONS


Behavioral treatments addressing both smoking and depression are efficacious for sustaining high quit rates at one year. Adding CM to CBT+BA for smoking cessation is highly cost-effective, with an estimated net benefit of €4,704 (US$5,344.80).
IMPLICATIONS


Informing on the cost-effectiveness of CM might expedite the translation of research findings into clinical practice. Findings suggested that CM is feasible and highly cost-effective, confirming that its implementation is worthwhile. At a CM cost per patient of €410.64 (US$465.14), the net benefit equals €4,704 (US$5,344.80), although even starting from a minimum investment of €20 (US$22.72) was cost-effective.",2020,"Point-prevalence abstinence [53.3% (32/60)] was superior in participants receiving CBT+BA+CM compared to those in CBT+BA [23.3% (14/60)], but both groups were equally likely to present sustained reductions in depression.","['120 smokers with depression [% females: 70.8%; mean age: 51.67(SD = 9.59', 'cigarette smokers with depression']","['Contingency management (CM', 'cognitive-behavioral therapy (CBT)+behavioral activation (BA) treatment', 'CBT+BA+CM', 'contingency management']","['Point-prevalence abstinence', 'prevalence abstinence, continuous abstinence, longest duration of abstinence (LDA), and Beck-Depression Inventory-II (BDI-II) scores', 'resource utilization, unit costs per patient, and incremental cost per additional LDA']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",120.0,0.0362158,"Point-prevalence abstinence [53.3% (32/60)] was superior in participants receiving CBT+BA+CM compared to those in CBT+BA [23.3% (14/60)], but both groups were equally likely to present sustained reductions in depression.","[{'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'González-Roz', 'Affiliation': 'Department of Psychology. University of Oviedo. Plaza Feijóo s/n, Oviedo, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Weidberg', 'Affiliation': 'Department of Psychology. University of Oviedo. Plaza Feijóo s/n, Oviedo, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'García-Pérez', 'Affiliation': 'Department of Psychology. University of Oviedo. Plaza Feijóo s/n, Oviedo, Spain.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Martínez-Loredo', 'Affiliation': 'Department of Psychology. University of Oviedo. Plaza Feijóo s/n, Oviedo, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Secades-Villa', 'Affiliation': 'Department of Psychology. University of Oviedo. Plaza Feijóo s/n, Oviedo, Spain.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa146']
1851,32772215,Smile esthetic evaluation of mucogingival reconstructive surgery.,"To assess the difference in smile esthetic impact of Coronally Advanced Flap (CAF) with or without the adjunct of a collagen matrix (CMX) used as root coverage procedures. Subjects with esthetic demands showing multiple upper gingival recessions of at least 2 mm, without interproximal attachment loss and cervical abrasion no more than 1 mm were recruited and randomized to CAF plus CMX or CAF alone. The Smile Esthetic Index (SEI) was adopted to quantify the quality of the smile recorded at baseline and 12 months after treatment for each treatment group. In addition, between group difference in the SEI was calculated. 24 Patients were treated and analysed. At baseline, mean gingival recession depths were 2.3 ± 0.7 mm for Test group and 2.6 ± 1.0 mm for Control group. After 1 year, the residual recession depth was 0.3 ± 0.4 mm in the CAF + CMX group and 0.6 ± 0.3 mm in the control group. The SEI at baseline was 8.1 ± 1.0 and 7.9 ± 0.7 for Test and Control group, respectively. The between groups difference at 12 months in SEI was 0.4 (95% C.I. - 0.0 to 0.8, P = 0.0697). Twelve months after treatment, CAF + CMX provided a similar SEI compared to CAF alone and the adjunct of a collagen matrix did not show a different impact on the smile esthetic appearance.",2020,"Twelve months after treatment, CAF + CMX provided a similar SEI compared to CAF alone and the adjunct of a collagen matrix did not show a different impact on the smile esthetic appearance.","['Subjects with esthetic demands showing multiple upper gingival recessions of at least 2\xa0mm, without interproximal attachment loss and cervical abrasion no more than 1\xa0mm', '24 Patients were treated and analysed']","['CAF\u2009+\u2009CMX', 'Coronally Advanced Flap (CAF) with or without the adjunct of a collagen matrix (CMX', 'CAF', 'CAF plus CMX', 'mucogingival reconstructive surgery']","['SEI', 'Smile Esthetic Index (SEI', 'smile esthetic appearance', 'smile esthetic impact', 'residual recession depth', 'mean gingival recession depths']","[{'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C1262285', 'cui_str': 'Cervical abrasion'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}]","[{'cui': 'C0037363', 'cui_str': 'Smiling'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}]",24.0,0.0580653,"Twelve months after treatment, CAF + CMX provided a similar SEI compared to CAF alone and the adjunct of a collagen matrix did not show a different impact on the smile esthetic appearance.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Rotundo', 'Affiliation': 'Honorary Associate Professor in Periodontology, UCL Eastman Dental Institute, London, UK. r.rotundo@ucl.ac.uk.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Genzano', 'Affiliation': 'Private Practice, Prato, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Nieri', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Covani', 'Affiliation': 'Istituto Stomatologico Toscano, Camaiore, Italy.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Peñarrocha-Oltra', 'Affiliation': 'Valencia University Medical and Dental School, Valencia, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Peñarrocha-Diago', 'Affiliation': "", Via Vasco de' Gama 33/3, 50127, Florence, Italy.""}]",Odontology,['10.1007/s10266-020-00544-6']
1852,32772244,"Isokinetic eccentric exercise substantially improves mobility, muscle strength and size, but not postural sway metrics in older adults, with limited regression observed following a detraining period.","INTRODUCTION


Eccentric exercise can reverse age-related decreases in muscle strength and mass; however, no data exist describing its effects on postural sway. As the ankle may be more important for postural sway than hip and knee joints, and with older adults prone to periods of inactivity, the effects of two 6-week seated isokinetic eccentric exercise programmes, and an 8-week detraining period, were examined in 27 older adults (67.1 ± 6.0 years).
METHODS


Neuromuscular parameters were measured before and after training and detraining periods with subjects assigned to ECC (twice-weekly eccentric-only hip and knee extensor contractions) or ECC PF  (identical training with additional eccentric-only plantarflexor contractions) training programmes.
RESULTS


Significant (P < 0.05) increases in mobility (decreased timed-up-and-go time [- 7.7 to - 12.0%]), eccentric strength (39.4-58.8%) and vastus lateralis thickness (9.8-9.9%) occurred after both training programmes, with low-to-moderate weekly rate of perceived exertion (3.3-4.5/10) reported. No significant change in any postural sway metric occurred after either training programme. After 8 weeks of detraining, mobility (- 8.2 to - 11.3%), eccentric strength (30.5-50.4%) and vastus lateralis thickness (6.1-7.1%) remained significantly greater than baseline in both groups.
CONCLUSION


Despite improvements in functional mobility, muscle strength and size, lower-limb eccentric training targeting hip, knee and ankle extensor muscle groups was not sufficient to influence static balance. Nonetheless, as the beneficial functional and structural adaptations were largely maintained through an 8-week detraining period, these findings have important implications for clinical exercise prescription as the exercise modality, low perceived training intensity, and adaptive profile are well suited to the needs of older adults.",2020,", lower-limb eccentric training targeting hip, knee and ankle extensor muscle groups was not sufficient to influence static balance.","['27 older adults (67.1\u2009±\u20096.0 years', 'older adults']","['Eccentric exercise', 'seated isokinetic eccentric exercise programmes', 'ECC (twice-weekly eccentric-only hip and knee extensor contractions) or ECC PF  (identical training with additional eccentric-only plantarflexor contractions) training programmes', 'Isokinetic eccentric exercise']","['postural sway metric', 'vastus lateralis thickness', 'mobility, muscle strength and size, but not postural sway metrics', 'functional mobility, muscle strength and size', 'mobility', 'eccentric strength']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C4077283', 'cui_str': '67Ga-ethylenecysteamine cysteine'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}]",27.0,0.0138365,", lower-limb eccentric training targeting hip, knee and ankle extensor muscle groups was not sufficient to influence static balance.","[{'ForeName': 'Anthony David', 'Initials': 'AD', 'LastName': 'Kay', 'Affiliation': 'Centre for Physical Activity and Life Sciences, Faculty of Art, Science and Technology, University of Northampton, Northamptonshire, UK. tony.kay@northampton.ac.uk.'}, {'ForeName': 'Anthony John', 'Initials': 'AJ', 'LastName': 'Blazevich', 'Affiliation': 'Centre for Exercise and Sports Science Research (CESSR), School of Exercise and Health Sciences, Edith Cowan University, Joondalup, Australia.'}, {'ForeName': 'Millie', 'Initials': 'M', 'LastName': 'Fraser', 'Affiliation': 'Centre for Physical Activity and Life Sciences, Faculty of Art, Science and Technology, University of Northampton, Northamptonshire, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Ashmore', 'Affiliation': 'Centre for Physical Activity and Life Sciences, Faculty of Art, Science and Technology, University of Northampton, Northamptonshire, UK.'}, {'ForeName': 'Mathew William', 'Initials': 'MW', 'LastName': 'Hill', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, School of Life Sciences, Coventry University, Warwickshire, UK.'}]",European journal of applied physiology,['10.1007/s00421-020-04466-7']
1853,32779001,The effects of β 1  and β 1+2  adrenergic receptor blockade on the exercise-induced mobilization and ex vivo expansion of virus-specific T cells: implications for cellular therapy and the anti-viral immune effects of exercise.,"The adoptive transfer of donor-derived virus-specific T cells (VSTs) is an effective treatment for infections following allogeneic hematopoietic cell transplantation. Acute exercise mobilizes effector lymphocytes and VSTs to the circulation and augments the ex vivo manufacture of VSTs. This study determined if β 2  adrenergic receptor (AR) signaling precipitated the VST response to acute exercise. Healthy participants (n = 12) completed 30 min of steady-state cycling exercise after ingesting a placebo, a β 1 + 2  AR antagonist (nadolol) or a β 1  AR antagonist (bisoprolol). Circulating VSTs to cytomegalovirus (CMV), Epstein-Barr virus (EBV), and adenovirus (AdV) antigens were enumerated before and after exercise, and peripheral blood mononuclear cells were cultured with viral peptides for 8 days to expand multi-VSTs. Compared with placebo, nadolol blunted the exercise-induced mobilization of CMV-VSTs (Δ VSTs/100,000 CD3 +  T cells = 93 ± 104 vs. 22 ± 91 for placebo and nadolol, respectively; p = 0.036), while bisoprolol did not, despite both drugs evoking similar reductions in exercising heart rate and blood pressure. Circulating AdV and EBV VSTs (VSTs/mL blood) only increased after exercise with placebo. Although not significant, nadolol partially mitigated exercise-induced increases in multi-VST expansion, particularly in participants that demonstrated an exercise-induced increase in VST expansion. We conclude that exercise-induced enhancements in VST mobilization and expansion are at least partially β 2  AR mediated, thus highlighting a role for the β 2  AR in targeted therapy for the augmentation of VST immune cell therapeutics in the allogeneic adoptive transfer setting. Moreover, long-term regular exercise may provide additional viral protection in the host through frequent β 2  AR-dependent mobilization and redistribution of VSTs cumulated with each bout of exercise.",2020,"Compared with placebo, nadolol blunted the exercise-induced mobilization of CMV-VSTs (Δ VSTs/100,000 CD3 +  T cells = 93 ± 104 vs. 22 ± 91 for placebo and nadolol, respectively; p = 0.036), while bisoprolol did not, despite both drugs evoking similar reductions in exercising heart rate and blood pressure.","['allogeneic hematopoietic cell transplantation', 'Healthy participants (n\u2009=\u200912) completed']","['placebo, nadolol', 'nadolol', '30\xa0min of steady-state cycling exercise after ingesting a placebo, a β 1\u2009+\u20092  AR antagonist (nadolol) or a β 1  AR antagonist (bisoprolol', 'adoptive transfer of donor-derived virus-specific T cells (VSTs', 'placebo']","['Circulating VSTs to cytomegalovirus (CMV), Epstein-Barr virus (EBV), and adenovirus (AdV', 'exercise-induced mobilization of CMV-VSTs', 'VST expansion', 'exercising heart rate and blood pressure', 'Circulating AdV and EBV VSTs (VSTs/mL blood', 'multi-VST expansion']","[{'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027302', 'cui_str': 'Nadolol'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0053799', 'cui_str': 'Bisoprolol'}, {'cui': 'C0376518', 'cui_str': 'Adoptive Transfer'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0014644', 'cui_str': 'Epstein-Barr Virus'}, {'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]",,0.045439,"Compared with placebo, nadolol blunted the exercise-induced mobilization of CMV-VSTs (Δ VSTs/100,000 CD3 +  T cells = 93 ± 104 vs. 22 ± 91 for placebo and nadolol, respectively; p = 0.036), while bisoprolol did not, despite both drugs evoking similar reductions in exercising heart rate and blood pressure.","[{'ForeName': 'Hawley E', 'Initials': 'HE', 'LastName': 'Kunz', 'Affiliation': 'Laboratory of Integrated Physiology, Department of Health and Human Performance, University of Houston, Houston, TX, USA.'}, {'ForeName': 'Nadia H', 'Initials': 'NH', 'LastName': 'Agha', 'Affiliation': 'Laboratory of Integrated Physiology, Department of Health and Human Performance, University of Houston, Houston, TX, USA.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Merced Experimental Social and Health Psychology Laboratory, Stress and Health Laboratory, Department of Psychological Sciences, University of California Merced, Merced, CA, USA.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'LaVoy', 'Affiliation': 'Laboratory of Integrated Physiology, Department of Health and Human Performance, University of Houston, Houston, TX, USA.'}, {'ForeName': 'Kyle A', 'Initials': 'KA', 'LastName': 'Smith', 'Affiliation': 'Department of Nutritional Sciences, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Preteesh', 'Initials': 'P', 'LastName': 'Mylabathula', 'Affiliation': 'Department of Nutritional Sciences, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Douglass', 'Initials': 'D', 'LastName': 'Diak', 'Affiliation': 'Department of Nutritional Sciences, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Forrest L', 'Initials': 'FL', 'LastName': 'Baker', 'Affiliation': 'Department of Nutritional Sciences, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': ""O'Connor"", 'Affiliation': 'Laboratory of Integrated Physiology, Department of Health and Human Performance, University of Houston, Houston, TX, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Bond', 'Affiliation': 'College of Pharmacy, Science and Engineering Research Center, The University of Houston, Houston, TX, USA.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Katsanis', 'Affiliation': 'Department of Pediatrics, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Bollard', 'Affiliation': ""Center for Cancer and Immunology Research, Children's Research Institute, Children's National Health System and The George Washington University, Washington, D.C., USA.""}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Simpson', 'Affiliation': 'Laboratory of Integrated Physiology, Department of Health and Human Performance, University of Houston, Houston, TX, USA. rjsimpson@email.arizona.edu.'}]",Cell stress & chaperones,['10.1007/s12192-020-01136-7']
1854,32779011,Efficacy of gel-based artificial saliva on Candida colonization and saliva properties in xerostomic post-radiotherapy head and neck cancer patients: a randomized controlled trial.,"OBJECTIVE


To evaluate the efficacy of an edible artificial saliva gel, oral moisturizing jelly (OMJ), and a topical commercial gel (GC dry mouth gel) on Candida colonization and saliva properties.
MATERIALS AND METHODS


This study was a secondary analysis of a single-blinded randomized controlled trial conducted in xerostomic post-radiotherapy head and neck cancer patients. Candida colonization, stimulated salivary flow rate (SSFR), saliva pH, and buffering capacity (BC) were measured at 0, 1, and 2 months after each intervention. Candida colonization was quantified by colony counts and species identified by Candida Chromagar, polymerase chain reaction, and API 20C AUX system. Statistical significance level was 0.05.
RESULTS


A total of 56 participants in OMJ (N = 30) and GC (N = 26) groups completed the study. OMJ significantly increased saliva pH (p = 0.042) and BC (p = 0.013) after 1-month use, while GC only improved saliva pH (p = 0.027). Both interventions tended to increase SSFR but only GC had a significant increase at 2 months (p = 0.015). GC and OMJ significantly decreased the number of Candida species at 1 and 2 months, respectively. Both groups tended to reduce Candida counts but not significant.
CONCLUSIONS


Both OMJ and GC saliva gels could improve saliva pH and decrease the number of Candida species. OMJ is superior to GC in its buffering capacity, while GC may better improve salivary flow rate. Long-term and large-scale study is warranted to test the efficacy of artificial saliva in oral health improvement.
CLINICAL RELEVANCE


OMJ and GC gel could decrease the number of Candida species and improve saliva properties in post-radiation xerostomic patients.
TRIAL REGISTRATION NUMBER


Clinicaltrials.gov NCT03035825. Date of registration: 25th January 2017.",2020,"OMJ significantly increased saliva pH (p = 0.042) and BC (p = 0.013) after 1-month use, while GC only improved saliva pH (p = 0.027).","['56 participants in OMJ (N\xa0=\u200930) and GC (N\xa0=\u200926) groups completed the study', 'post-radiation xerostomic patients', 'head and neck cancer patients', 'xerostomic post-radiotherapy head and neck cancer patients']","['topical commercial gel (GC dry mouth gel', 'gel-based artificial saliva', 'edible artificial saliva gel, oral moisturizing jelly (OMJ', 'GC and OMJ', 'xerostomic post-radiotherapy', 'OMJ']","['SSFR', 'Candida colonization, stimulated salivary flow rate (SSFR), saliva pH, and buffering capacity (BC', 'Candida colonization and saliva properties', 'Candida colonization', 'saliva pH', 'salivary flow rate', 'Candida counts', 'number of Candida species', 'saliva properties']","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0445177', 'cui_str': 'Post-radiation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036088', 'cui_str': 'Artificial saliva'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0429177', 'cui_str': 'Salivary flow rate'}, {'cui': 'C2242557', 'cui_str': 'Candida colonisation'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0006836', 'cui_str': 'Candida'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",56.0,0.251714,"OMJ significantly increased saliva pH (p = 0.042) and BC (p = 0.013) after 1-month use, while GC only improved saliva pH (p = 0.027).","[{'ForeName': 'Aroonwan', 'Initials': 'A', 'LastName': 'Lam-Ubol', 'Affiliation': 'Department of Oral Surgery and Oral Medicine, Faculty of Dentistry, Srinakharinwirot University, 114 Sukhumvit 23, Wattana, Bangkok, 10110, Thailand. aroonwan@gmail.com.'}, {'ForeName': 'Oranart', 'Initials': 'O', 'LastName': 'Matangkasombut', 'Affiliation': 'Department of Microbiology and Research Unit on Oral Microbiology and Immunology, Faculty of Dentistry, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Dunyaporn', 'Initials': 'D', 'LastName': 'Trachootham', 'Affiliation': 'Institute of Nutrition, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Supanat', 'Initials': 'S', 'LastName': 'Tarapan', 'Affiliation': 'Department of Oral Surgery and Oral Medicine, Faculty of Dentistry, Srinakharinwirot University, 114 Sukhumvit 23, Wattana, Bangkok, 10110, Thailand.'}, {'ForeName': 'Vanthana', 'Initials': 'V', 'LastName': 'Sattabanasuk', 'Affiliation': 'Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sineepat', 'Initials': 'S', 'LastName': 'Talungchit', 'Affiliation': 'Department of Oral Surgery and Oral Medicine, Faculty of Dentistry, Srinakharinwirot University, 114 Sukhumvit 23, Wattana, Bangkok, 10110, Thailand.'}, {'ForeName': 'Wannaporn', 'Initials': 'W', 'LastName': 'Paemuang', 'Affiliation': 'Department of Vascular Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Tawaree', 'Initials': 'T', 'LastName': 'Phonyiam', 'Affiliation': 'Institute of Nutrition, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Orapin', 'Initials': 'O', 'LastName': 'Chokchaitam', 'Affiliation': 'Chonburi Cancer Hospital, Chonburi, Thailand.'}, {'ForeName': 'On-Ong', 'Initials': 'OO', 'LastName': 'Mungkung', 'Affiliation': 'Chonburi Cancer Hospital, Chonburi, Thailand.'}]",Clinical oral investigations,['10.1007/s00784-020-03484-1']
1855,32779012,Effectiveness of the static-guided endodontic technique for accessing the root canal through MTA and its effect on fracture strength.,"OBJECTIVES


(1) To evaluate the effectiveness of the static-guided (SG) endodontics technique for accessing the root canal through the mineral trioxide aggregate (MTA) and (2) to evaluate the effect of this technique on the fracture strength of teeth.
MATERIALS AND METHODS


Thirty mandibular premolars were used in the present study. After standard coronal access cavity preparation, root canals were prepared up to size #80 to simulate an immature root apex. White MTA was placed approximately 3 mm below the cementoenamel junction (CEJ), as placed in regenerative endodontic procedures. After the MTA had set, the cavity was restored with a resin composite material. The teeth were randomly divided into two groups (n = 15). In the control group, the composite resin and MTA were removed without any guide. In the SG-access group, a cone beam computed tomography (CBCT) scan was performed, 3D-printed guides were designed and fabricated, and then the composite resin and MTA were removed with a guide. One inexperienced operator performed the removal of the composite resin and MTA in all groups. Pre- and post-operative periapical radiographs were taken. The mishaps and time to penetration to root canal were recorded. After that, the root canals were filled, and the access cavities were restored. The samples were subjected to a fracture strength test. Data were analyzed using Mann-Whitney U, independent samples of T test, and chi-square tests at 95% confidence level (P = 0.05).
RESULTS


There were significant differences between the control and SG-access groups in terms of mishaps and time to penetration to the root canal through the MTA barrier (P < 0.05). The SG-access group required the shorter time as compared with the control group. Mishaps did not occur in the SG-access group. The SG-access group exhibited the significantly preserved fracture resistance of the teeth as compared with the control group (P < 0.05). Non-restorable failure occurred more frequently in the control group than in the SG-access group.
CONCLUSIONS


Within the limitations of the present study, the SG endodontic technique yielded favorable results with respect to time, mishaps, and fracture strength.
CLINICAL RELEVANCE


The static-guided endodontics technique may provide advantages to the clinician for MTA removal.",2020,There were significant differences between the control and SG-access groups in terms of mishaps and time to penetration to the root canal through the MTA barrier (P < 0.05).,['Thirty mandibular premolars'],"['static-guided endodontic technique', 'static-guided (SG) endodontics technique', 'cone beam computed tomography (CBCT) scan']","['fracture strength', 'fracture resistance', 'fracture strength of teeth']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C4704755', 'cui_str': 'Fracture Strength'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]",,0.0261963,There were significant differences between the control and SG-access groups in terms of mishaps and time to penetration to the root canal through the MTA barrier (P < 0.05).,"[{'ForeName': 'Afzal', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Pacific Dental College and Hospital, Udaipur, Rajasthan, 313024, India. abu.ali.4k@gmail.com.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Arslan', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Istanbul Health Sciences University, Istanbul, Turkey.'}]",Clinical oral investigations,['10.1007/s00784-020-03507-x']
1856,32779029,Virtual reality for intravenous placement in the emergency department-a randomized controlled trial.,"This study sought to determine whether adding virtual reality (VR) was superior to standard of care alone in facilitating reduction in pain and anxiety among children who underwent intravenous catheterization in the emergency department (ED). Sixty-six children aged 6-16 years who needed intravenous placement received VR, or standard of care in the ED (videos, television, iPad, child life specialist). Outcome measures included change in pain score, level of anxiety, patient and parent satisfaction (pain and anxiety), number of trials, and procedure time. Compared with controls, the intervention group had similar age, sex, number of trials, and anesthetic use. Time of procedure was shorter in the VR group (median 5 min) but this was not statistically significant compared with 7 min for the control group. Pain in the intervention group was lower, even before the procedure. Difference in pain (before and after) and anxiety (after the procedure) were similar in both groups. Satisfaction from anxiety management was higher for the VR group (p < 0.007) and children rated VR significantly more ""fun"" (p < 0.024).Conclusion: VR was an effective distraction tool and increased satisfaction from anxiety management for this common pediatric procedure, and should be incorporated in management of anxiety in children in the ED setting.Trial registration: clinicaltrials.gov ID NCT03681730, https://clinicaltrials.gov/ct2/show/NCT03681730 What is Known: • Virtual reality is an evolving computer technology that shows some promise in the areas of acute and chronic pain management due to its ability to create effective distraction. What is New: • We report that among children in the emergency setting with intravenous catheterization, satisfaction from the use of VR for anxiety management should support implementation of VR systems for this procedure.",2020,"Satisfaction from anxiety management was higher for the VR group (p < 0.007) and children rated VR significantly more ""fun"" (p < 0.024).Conclusion: VR was an effective distraction tool and increased satisfaction from anxiety management for this common pediatric procedure, and should be incorporated in management of anxiety in children in the ED setting.","['Sixty-six children aged 6-16 years who needed intravenous placement received VR, or standard of care in the ED (videos, television, iPad, child life specialist', 'children who underwent intravenous catheterization in the emergency department (ED']","['virtual reality (VR', 'https://clinicaltrials.gov/ct2/show/NCT03681730']","['pain and anxiety', 'Time of procedure', 'anxiety', 'Satisfaction from anxiety management', 'Pain', 'change in pain score, level of anxiety, patient and parent satisfaction (pain and anxiety), number of trials, and procedure time', 'pain']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0039461', 'cui_str': 'Television'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0871652', 'cui_str': 'Management of anxiety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",66.0,0.112043,"Satisfaction from anxiety management was higher for the VR group (p < 0.007) and children rated VR significantly more ""fun"" (p < 0.024).Conclusion: VR was an effective distraction tool and increased satisfaction from anxiety management for this common pediatric procedure, and should be incorporated in management of anxiety in children in the ED setting.","[{'ForeName': 'Ran D', 'Initials': 'RD', 'LastName': 'Goldman', 'Affiliation': 'The Pediatric Research in Emergency Therapeutics (PRETx) Program, Division of Pediatric Emergency Medicine, Department of Pediatrics, University of British Columbia, Vancouver, Canada. rgoldman@cw.bc.ca.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Behboudi', 'Affiliation': 'Emergency Medicine, Peace Arch Hospital, White Rock, BC, Canada.'}]",European journal of pediatrics,['10.1007/s00431-020-03771-9']
1857,32779141,Daily Short Message Service Reminders Increase Treatment Compliance and Efficacy in Outpatients with Functional Dyspepsia: a Prospective Randomized Controlled Trial.,"BACKGROUND


Many outpatients with functional dyspepsia (FD) do not follow the medication schedule recommendations, which can lead to illness relapse.
OBJECTIVE


To investigate whether short message service (SMS) reminders improve medication regimen adherence and therapeutic efficacy in outpatients with FD.
DESIGN


Participants with FD were randomly allocated to the control group or intervention group. Patients in the control group received a 4-week medication treatment with no reminders, those in the intervention group received medication treatment plus a daily SMS reminder of dose and medication time.
PARTICIPANTS


Newly diagnosed FD patients from April 2019 to June 2019 were recruited from the GI outpatient clinics at Renji Hospital.
MEASUREMENTS


The scores for FD symptoms (LDQ) and psychological conditions (PHQ-9 for depression and GAD-7 for anxiety) were assessed before and after the treatment. The medication possession ratio (MPR) was calculated.
KEY RESULTS


A total of 352 eligible patients was enrolled in the study. The overall compliance rates of patients in the intervention and control groups were 87.5% and 80.7% in the intention-to-treat (ITT) analysis (P = 0.08) and 94.48% and 86.59% in per-protocol (PP) analysis (P = 0.015), respectively. In the intervention group, the compliance rate of younger patients (age ≤ 40 years) was significantly higher than that of age-matched patients in the control group (ITT: 86.1% vs. 70.5%, P = 0.018). Compared with the control group, the reduction in scores of LDQ (9.33 vs. 8.02, P = 0.017), PHQ-9 (6.97 vs. 5.69, P = 0.004), and GAD-7 (8.70 vs.7.53, P = 0.028) was significantly greater in patients receiving SMS reminders. The MPR of patients positively correlated with the reduction in scores of LDQ, PHQ-9, and GAD-7 in both groups.
CONCLUSIONS


SMS reminders can improve treatment compliance and efficacy in patients with FD.
TRIAL REGISTRATION


NCT04052750.",2020,"The MPR of patients positively correlated with the reduction in scores of LDQ, PHQ-9, and GAD-7 in both groups.
","['352 eligible patients was enrolled in the study', 'Outpatients with Functional Dyspepsia', 'outpatients with FD', 'Participants with FD', 'outpatients with functional dyspepsia (FD', 'patients with FD', 'Newly diagnosed FD patients from April 2019 to June 2019 were recruited from the GI outpatient clinics at Renji Hospital']","['short message service (SMS) reminders', 'control group or intervention group', '4-week medication treatment with no reminders, those in the intervention group received medication treatment plus a daily SMS reminder of dose and medication time', 'Daily Short Message Service Reminders']","['scores for FD symptoms (LDQ) and psychological conditions (PHQ-9 for depression and GAD-7 for anxiety', 'medication possession ratio (MPR', 'GAD-7', 'scores of LDQ', 'overall compliance rates', 'treatment compliance and efficacy', 'PHQ-9 ', 'scores of LDQ, PHQ-9, and GAD-7', 'compliance rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",352.0,0.0511439,"The MPR of patients positively correlated with the reduction in scores of LDQ, PHQ-9, and GAD-7 in both groups.
","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Institute of Digestive Disease, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Qing-Qing', 'Initials': 'QQ', 'LastName': 'Luo', 'Affiliation': 'Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Institute of Digestive Disease, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Institute of Digestive Disease, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Institute of Digestive Disease, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Sheng-Liang', 'Initials': 'SL', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Institute of Digestive Disease, Shanghai Jiao Tong University, Shanghai, China. chenslmd@163.com.'}]",Journal of general internal medicine,['10.1007/s11606-020-06088-3']
1858,32779223,Understanding How e-Health Interventions Meet Psychosocial Needs of Breast Cancer Patients: The Pathways of Influence on Quality of Life and Cancer Concerns.,"OBJECTIVE


This investigation explores how using different e-health interventions facilitates positive psychosocial changes and how these changes reduce cancer concerns and improve quality of life in breast cancer patients over time.
METHODS


A total of 326 breast cancer patients were randomly assigned to one of three e-health interventions: (1) Internet only, (2) the Comprehensive Health Enhancement Support System information and support services (CHESS-IS), or (3) CHESS with mentor. Proximal health outcomes such as information overload, emotional functioning, and social support were measured alongside distal outcomes like cancer concerns and quality of life. Participants completed surveys at four time points: pretest as a baseline, 6 weeks, 3 months, and 6 months.
RESULTS


Both interventions were effective in improving patient health beyond Internet only but they differed in type of change mechanism and clinical benefit. CHESS-IS enhanced proximal outcomes at three months through improved information competence. The CHESS with mentor intervention reduced breast cancer concerns at six months, mediated mainly by emotional-social competence and emotional functioning.
CONCLUSION


Using e-health interventions like CHESS can help patients improve cancer information management skills and emotional social-emotional functioning, contributing to better short-term health outcomes. Adding a human mentor can enhance the benefits of CHESS use, extending the experience among breast cancer patients. Theoretical, practical, and clinical implications of the study results are discussed. This article is protected by copyright. All rights reserved.",2020,"The CHESS with mentor intervention reduced breast cancer concerns at six months, mediated mainly by emotional-social competence and emotional functioning.
","['breast cancer patients over time', 'breast cancer patients', 'Breast Cancer Patients', '326 breast cancer patients']","['health interventions: (1) Internet only, (2) the Comprehensive Health Enhancement Support System information and support services (CHESS-IS), or (3) CHESS with mentor']","['quality of life', 'information overload, emotional functioning, and social support were measured alongside distal outcomes like cancer concerns and quality of life', 'cancer information management skills and emotional social-emotional functioning', 'breast cancer concerns', 'emotional-social competence and emotional functioning', 'Quality of Life and Cancer Concerns', 'patient health beyond Internet']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C5191353', 'cui_str': '326'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0748877', 'cui_str': 'Social Support System'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0012972', 'cui_str': 'Information Management'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]",326.0,0.0393434,"The CHESS with mentor intervention reduced breast cancer concerns at six months, mediated mainly by emotional-social competence and emotional functioning.
","[{'ForeName': 'Sojung Claire', 'Initials': 'SC', 'LastName': 'Kim', 'Affiliation': 'Department of Communication, George Mason University.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Hawkins', 'Affiliation': 'School of Journalism and Mass Communication, Center for Health Enhancement Systems Studies (CHESS), University of Wisconsin, Madison.'}, {'ForeName': 'Dhavan V', 'Initials': 'DV', 'LastName': 'Shah', 'Affiliation': 'School of Journalism and Mass Communication, Center for Health Enhancement Systems Studies (CHESS), University of Wisconsin, Madison.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Gustafson', 'Affiliation': 'Department of Industrial and Systems Engineering, Center for Health Enhancement Systems Studies (CHESS), University of Wisconsin, Madison.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Center for Tobacco Research and Intervention, School of Medicine and Public Health, University of Wisconsin, Madison.'}]",Psycho-oncology,['10.1002/pon.5512']
1859,32779231,Social competence group intervention (SOCO) for children with autism spectrum disorder: A pilot study.,"This study aimed to describe concept of social competence as a theoretical background for social skills group intervention for children with autism spectrum disorder (ASD). A model of social competence comprised of three components: social skills, social performance, and social adjustment. We also examined the feasibility and preliminary efficacy of the manualized Social Competence group intervention for children with autism spectrum disorder (SOCO) using a variety of outcome measures. The nine-month intervention included children groups, parental support groups and co-operation with teachers. A pilot study involved 23 children aged 7 to 12 years (n = 16 intervention, n = 7 control) and intervention outcomes were measured with questionnaires for parents and teachers, neuropsychological tests, and observations. The parents of the intervention group reported improvements in social skills and social adjustment, whereas the teachers reported increases in social performance. Findings also indicated that affect recognition skills, social overtures, and reactions to peers were improved in the intervention group. Although the evidence of the pilot study should be considered as preliminary, it gives some indication of the feasibility of the SOCO group intervention and supports the usability of the theoretical background and approach for multiple outcome measures.",2020,"The parents of the intervention group reported improvements in social skills and social adjustment, whereas the teachers reported increases in social performance.","['children with autism', 'children with autism spectrum disorder (SOCO', 'children with autism spectrum disorder (ASD', '23 children aged 7 to 12\xa0years (n\xa0=\xa016 intervention, n\xa0=\xa07 control) and intervention outcomes were measured with questionnaires for parents and teachers, neuropsychological tests, and observations']","['social skills group intervention', 'Social competence group intervention (SOCO', 'manualized Social Competence group intervention']","['recognition skills, social overtures, and reactions to peers', 'social skills and social adjustment', 'social performance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}]",23.0,0.0249499,"The parents of the intervention group reported improvements in social skills and social adjustment, whereas the teachers reported increases in social performance.","[{'ForeName': 'Anneli', 'Initials': 'A', 'LastName': 'Kylliäinen', 'Affiliation': 'Psychology, Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Satu', 'Initials': 'S', 'LastName': 'Häkkinen', 'Affiliation': 'Ludus Oy Tutkimus ja kuntoutuspalvelut, Mäkitorpantie 3 B, Helsinki, FI-00620, Finland.'}, {'ForeName': 'Sanelma', 'Initials': 'S', 'LastName': 'Eränen', 'Affiliation': 'Psychology, Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Rantanen', 'Affiliation': 'Psychology, Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Ebeling', 'Affiliation': 'Pedego Research Unit, Clinic of Child Psychiatry, University of Oulu and Oulu University Hospital, Finland.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Bölte', 'Affiliation': ""Department of Women's and Children's Health, Center of Neurodevelopmental Disorders at Karolinska Institutet (KIND), Division of Neuropsychiatry, Center for Psychiatry Research Karolinska Institutet & Region Stockholm, Sweden.""}, {'ForeName': 'Terhi M', 'Initials': 'TM', 'LastName': 'Helminen', 'Affiliation': 'Psychology, Faculty of Social Sciences, Tampere University, Tampere, Finland.'}]",Scandinavian journal of psychology,['10.1111/sjop.12675']
1860,32764634,"Randomised, double-blind, placebo-controlled trial of oral probiotic Streptococcus salivarius M18 on head and neck cancer patients post-radiotherapy: a pilot study.","Xerostomia detrimentally affects the oral health of many head and neck cancer patients who undergo radiotherapy. Its sequelae become an ongoing burden for patients that often manifest as periodontal disease and dental decay. Bacteria play a major role in the pathogenesis of these conditions and here we explore the use of an oral probiotic to beneficially modulate the oral bacterial community post-radiotherapy. In this pilot study, a four-week intervention with oral probiotic lozenges containing Streptococcus salivarius M18 was trialled in seven patients. Post-intervention changes in oral health and in the composition of the plaque and saliva bacterial communities were compared with six patients in a placebo group. An improvement in periodontal screening and plaque index scores was observed in both groups after the intervention period. The oral probiotic lozenges did not significantly impact bacterial community composition or diversity, nor did the probiotic lozenges increase the relative sequence abundance of ZOTU_1 (the probiotic-associated sequence assigned to S. salivarius) detected in the samples. Network analyses suggest negative interactions occurred between ZOTU_1 and species from the periopathogenic genera Campylobacter, Fretibacterium, Selenomonas and Treponema but further investigation is required to more fully understand the beneficial properties of this oral probiotic.",2020,"The oral probiotic lozenges did not significantly impact bacterial community composition or diversity, nor did the probiotic lozenges increase the relative sequence abundance of ZOTU_1 (the probiotic-associated sequence assigned to S. salivarius) detected in the samples.","['head and neck cancer patients post', 'seven patients', 'many head and neck cancer patients who undergo radiotherapy']","['oral probiotic lozenges', 'oral probiotic Streptococcus salivarius M18', 'radiotherapy', 'placebo']","['periodontal screening and plaque index scores', 'relative sequence abundance of ZOTU_1']","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}, {'cui': 'C0318179', 'cui_str': 'Streptococcus salivarius'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}]",7.0,0.0738193,"The oral probiotic lozenges did not significantly impact bacterial community composition or diversity, nor did the probiotic lozenges increase the relative sequence abundance of ZOTU_1 (the probiotic-associated sequence assigned to S. salivarius) detected in the samples.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Vesty', 'Affiliation': 'Department of Surgery, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Gear', 'Affiliation': 'Department of Otorhinolaryngology, Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Boutell', 'Affiliation': 'Oral Health, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Taylor', 'Affiliation': 'School of Biological Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Douglas', 'Affiliation': 'Department of Surgery, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Kristi', 'Initials': 'K', 'LastName': 'Biswas', 'Affiliation': 'Department of Surgery, The University of Auckland, Auckland, New Zealand. k.biswas@auckland.ac.nz.'}]",Scientific reports,['10.1038/s41598-020-70024-y']
1861,32764866,Binocular Visual Function in a Pre-Presbyopic Patient with Uniocular Cataract Undergoing Cataract Surgery with a Multifocal Intraocular Lens.,"Background/Aim


An increasing number of pre-presbyopic patients are undergoing uniocular cataract extraction. We aim to compare the binocular status of subjects with uniocular cataracts, implanted either with a multifocal or a monofocal intraocular lens (IOL).
Materials and Methods


Subjects were recruited from outpatient ophthalmology clinics and randomized to an IOL type. Corrected and uncorrected LogMAR distance visual acuity (VA) and near and intermediate VA using the Radner reading test were completed. The binocular tests included the Worth Four Dot Test, fixation disparity, TNO stereoacuity and foveal suppression assessment. In addition to the near activity vision questionnaire. The trial was closed early because the chosen multifocal lens had been superseded by newer models. We report two subjects, one receiving the multifocal IOL and a monofocal IOL control with the most comparable baseline characteristics.
Results


Both subjects experienced uncomplicated cataract surgery, showing clinically significant improved corrected distance VA, 0.06 LogMAR and -0.16 LogMAR in the monofocal and multifocal IOL, respectively. The multifocal subject had 30 seconds of arc stereoacuity indicating normal binocular vision. Only gross binocular single vision with no stereopsis was found in the monofocal IOL subject. The latter subject also had reduced near vision quality-of-life questionnaire results.
Conclusion


This two-patient case series demonstrates greater binocular near ability, with the multifocal IOL, in the pre-presbyopic patient undergoing uniocular cataract surgery. The case series highlights the need, and methodology for investigating further the functional and quality-of-life benefits of implanting multifocal IOLs in pre-presbyopic patients, those in their twenties and thirties, undergoing uniocular cataract surgery.",2020,"Both subjects experienced uncomplicated cataract surgery, showing clinically significant improved corrected distance VA, 0.06 LogMAR and -0.16 LogMAR in the monofocal and multifocal IOL, respectively.","['subjects with uniocular cataracts, implanted either with a multifocal or a monofocal intraocular lens (IOL', 'a Pre-Presbyopic Patient with Uniocular Cataract Undergoing Cataract Surgery with a Multifocal Intraocular Lens', 'pre-presbyopic patients are undergoing uniocular cataract extraction']",[],"['uncorrected LogMAR distance visual acuity (VA) and near and intermediate VA', 'Binocular Visual Function', 'Worth Four Dot Test, fixation disparity, TNO stereoacuity and foveal suppression assessment', 'corrected distance VA', 'near activity vision questionnaire']","[{'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205292', 'cui_str': 'Multifocal'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0493722', 'cui_str': 'Multifocal Intraocular Lens'}]",[],"[{'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C1690987', 'cui_str': 'Intermediate visual acuity'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0430908', 'cui_str': 'Worth four-dot test'}, {'cui': 'C0042791', 'cui_str': 'Binocular Disparity'}, {'cui': 'C1275505', 'cui_str': 'Stereoscopic acuity'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0295786,"Both subjects experienced uncomplicated cataract surgery, showing clinically significant improved corrected distance VA, 0.06 LogMAR and -0.16 LogMAR in the monofocal and multifocal IOL, respectively.","[{'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Wood', 'Affiliation': 'Nuffield Laboratory of Ophthalmology, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jasleen K', 'Initials': 'JK', 'LastName': 'Jolly', 'Affiliation': 'Nuffield Laboratory of Ophthalmology, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Groppe', 'Affiliation': 'Stoke Mandeville Hospital, Buckingham Healthcare NHS Trust, Walton, UK.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Benjamin', 'Affiliation': 'Stoke Mandeville Hospital, Buckingham Healthcare NHS Trust, Walton, UK.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Kirwan', 'Affiliation': 'Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Nishal', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Kent and Canterbury Hospital, East Kent Hospitals University NHS Foundation Trust, Canterbury, UK.'}, {'ForeName': 'Mostafa A', 'Initials': 'MA', 'LastName': 'Elgohary', 'Affiliation': 'Kingston Hospital, Kingston Hospital NHS Foundation Trust, Kingston Upon Thames, UK.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'MacLaren', 'Affiliation': 'Nuffield Laboratory of Ophthalmology, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S254532']
1862,32764872,"Clostridium histolyticum  (AA4500) for the Treatment of Adhesive Capsulitis of the Shoulder: A Randomised Double-Blind, Placebo-Controlled Study for the Safety and Efficacy of Collagenase - Single Site Report.","Background/Hypothesis


Adhesive capsulitis of the shoulder results in pain and restricted movement of the glenohumeral joint. Hypothesis: There would be a difference in active range of movement in the affected shoulder of patients with adhesive capsulitis after receiving a series of injections of collagenase  Clostridium histolyticum  (CCH) compared to placebo.
Methods


This study reports the results from a single site that was part of a 321-participant, multicenter, double-blind, prospective parallel-group, randomized controlled clinical trial. Inclusion criteria: over 18 years of age, unilateral idiopathic adhesive capsulitis for >3 months, but <12 months. Exclusion criteria: recent physical therapy, injections, subacromial impingement, calcific tendonitis or glenohumeral joint arthritis in the affected shoulder. Subjects were randomized 3:1 to receive CCH 0.58 mg or placebo under ultrasound guidance. Injections were on days 1, 22, and 43. The primary outcome measure was a functional assessment of active range of movement.
Results


Overall, 37 patients were screened, 26 subjects were excluded, and 11 subjects were randomly assigned to the treatment group (n=9) or the control group (n=2). Both control and treatment groups showed improvement in ROM between baseline and day 95. In the treatment group, AROM improved from the baseline of 272.89° (SD 86.25) to 462.11° (SD 96.89) and the control group from 246.00° (SD 5.66) to 451.50° (SD 50.20) at day 95 with no statistical difference between groups p=0.78. Site data were in line with the whole study findings. Treatment-related adverse events at the injection site, including haematoma (bruising) and localised pain and swelling, were common.
Conclusion


Although the participants showed improvement in function, statistical significance was neither reached in the site nor the overall study cohort. Given the adverse events and the potential risks of the procedure, we would not recommend this drug for the treatment of adhesive capsulitis of the shoulder.
Level of Evidence


2, cohort from one site of RCT.",2020,"Treatment-related adverse events at the injection site, including haematoma (bruising) and localised pain and swelling, were common.
","['Inclusion criteria: over 18 years of age, unilateral idiopathic adhesive capsulitis for >3 months, but <12 months', 'Adhesive Capsulitis of the Shoulder', '37 patients were screened, 26 subjects were excluded, and 11 subjects']","['CCH 0.58 mg or placebo', 'Placebo', 'Clostridium histolyticum  (AA4500', 'placebo']","['functional assessment of active range of movement', 'haematoma (bruising) and localised pain and swelling', 'AROM', 'ROM']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0158300', 'cui_str': 'Capsulitis, Adhesive'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0311223', 'cui_str': 'Adhesive capsulitis of shoulder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C4517463', 'cui_str': '0.58'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0315088', 'cui_str': 'Clostridium histolyticum'}]","[{'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0003805', 'cui_str': 'Androstenedione Aromatase'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}]",26.0,0.446359,"Treatment-related adverse events at the injection site, including haematoma (bruising) and localised pain and swelling, were common.
","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Fitzpatrick', 'Affiliation': 'Centre for Health and Exercise Sports Medicine, School of Health Sciences, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Christen', 'Initials': 'C', 'LastName': 'Richardson', 'Affiliation': 'Medical School, College of Health and Medicine, Australian National University, Acton, ACT, Australia.'}, {'ForeName': 'Ianiv', 'Initials': 'I', 'LastName': 'Klaber', 'Affiliation': 'Orthopaedic Surgery Department, School of Medicine, Pontifical Catholic University of Chile, Santiago, Chile.'}, {'ForeName': 'Martin D', 'Initials': 'MD', 'LastName': 'Richardson', 'Affiliation': 'Centre for Health and Exercise Sports Medicine, School of Health Sciences, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Parkville, VIC, Australia.'}]","Drug design, development and therapy",['10.2147/DDDT.S259228']
1863,32764878,Does an Earlier or Late Intravenous Injection of Ondansetron Affect the Dose of Phenylephrine Needed to Prevent Spinal-Anesthesia Induced Hypotension in Cesarean Sections?,"Background


There was controversy about ondansetron can reduce the incidence of spinal-induced hypotension and decrease the consumption of vasopressor in cesarean delivery with spinal anesthesia. We hypothesized that different timing of ondansetron administration may contribute to the controversy. Therefore, we aimed to determine the effect of different timing of ondansetron administration on the dose requirement of preventing phenylephrine via comparing the ED 50  of prophylactic phenylephrine.
Methods


Seventy-five parturients were finally enrolled in this prospective, randomized, double-blinded dose finding study. Ondansetron or placebo was administered 5 min or 15 min before intrathecal injection. Up-down allocation method was used to determine the dose of prophylactic phenylephrine for each parturient in the three groups. The initial infusion rate of first patient was 0.5 µg/kg/min. Then, the rate for next patient was varied with increasing or decreasing of 0.05 μg/kg/min according to the response of the previous patient. An effective dose was defined as no hypotension occurred during the study period. An ineffective dose was defined as hypotension occurred during the study period. Study period in this study is from intrathecal injection to neonatal delivery. ED 50  of phenylephrine infusion was calculated by probit regression.
Results


The ED 50  of intravenous phenylephrine calculated by probit analysis was 0.33 (95% CI 0.20 to 0.38) µg/kg/min and 0.36 (95% CI 0.32 to 0.38) µg/kg/min in group A and B, and 0.41 (95% CI 0.37 to 0.44) µg/kg/min in group C for patients undergoing cesarean delivery with combined spinal-epidural anesthesia.
Conclusion


An earlier administration of 4 mg prophylactic ondansetron contributed no benefits for lowing the dose of prophylactic phenylephrine compared to a late administration, but can decrease the dose of preventing phenylephrine in patients undergoing cesarean delivery with combined spinal-epidural anesthesia. This finding may be useful for clinical practice and further studies.",2020,There was controversy about ondansetron can reduce the incidence of spinal-induced hypotension and decrease the consumption of vasopressor in cesarean delivery with spinal anesthesia.,"['Methods\n\n\nSeventy-five parturients', 'patients undergoing cesarean delivery with combined spinal-epidural anesthesia']","['phenylephrine', 'Ondansetron or placebo', 'prophylactic phenylephrine', 'Phenylephrine', 'ondansetron', 'Ondansetron', 'prophylactic ondansetron']","['hypotension', 'initial infusion rate']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}]","[{'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]",75.0,0.439756,There was controversy about ondansetron can reduce the incidence of spinal-induced hypotension and decrease the consumption of vasopressor in cesarean delivery with spinal anesthesia.,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': ""Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing, People's Republic of China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing, People's Republic of China.""}, {'ForeName': 'Xiufeng', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': ""Department of Obstetrics, Jiaxing University Affiliated Women and Children Hospital, Jiaxing, People's Republic of China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xiao', 'Affiliation': ""Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing, People's Republic of China.""}]","Drug design, development and therapy",['10.2147/DDDT.S257880']
1864,32764887,"The Safety and Efficacy of Ultrasound-Guided Bilateral Dual Transversus Abdominis Plane (BD-TAP) Block in ERAS Program of Laparoscopic Hepatectomy: A Prospective, Randomized, Controlled, Blinded, Clinical Study.","Purpose


Postoperative pain management for patients undergoing hepatic resection is still a challenge due to the risk of perioperative liver dysfunction. The transversus abdominis plane (TAP) block is a promising regional analgesic technique. However, the correct guidelines regarding the dose and regimen of local anesthetics in patients undergoing hepatic resection have yet to be established completely. This study aimed to evaluate the safety and efficacy of ultrasound-guided BD-TAP block with a large dose of ropivacaine in laparoscopic hepatectomy.
Patients and Methods


This prospective, blinded, randomized, controlled study was conducted with 50 patients who were scheduled for selective laparoscopic hepatectomy. Patients who received a BD-TAP block (3 mg/kg of ropivacaine diluted to 60 mL) with general anesthesia were categorized into the BD-TAP block group (n = 25), and those who received general anesthesia were categorized into the control group (n = 25). The primary outcomes were consumption of sufentanil within 48 hours post-operation and plasma ropivacaine concentration. The secondary outcomes were the severity of pain (at rest and upon coughing), nausea and/or vomiting, and quality of recovery.
Results


Compared with the control group, the patients in BD-TAP block group had a significant reduction of postoperative sufentanil consumption at 2 hours ( P  = 0.019), 24 hours ( P  = 0.001), and 48 hours ( P  = 0.001), and the visual analog scale (VAS) scores on coughing were significantly lower at postoperative 2 hours ( P  = 0.004). There were no statistically significant differences in postoperative nausea and/or vomiting, flatus, catheter removal, off-bed activity, liver function, or postoperative hospital stay. The mean peak total ropivacaine concentration was 1,067.85 ng/mL, which occurred 1 hour after administering the block, and mean free ropivacaine concentration was 52.32 ng/mL. The highest individual peak plasma concentration was 2,360.90 ng/mL at 45 min postinjection, and the free ropivacaine concentration was 139.29 ng/mL.
Conclusion


Ultrasound-guided BD-TAP block provides effective postoperative analgesia after laparoscopic hepatectomy. This study also confirms that ultrasound-guided BD-TAP blocks with 3 mg/kg ropivacaine during laparoscopic hepatectomy almost never results in the plasma ropivacaine concentrations associated with neurotoxicity.",2020,"There were no statistically significant differences in postoperative nausea and/or vomiting, flatus, catheter removal, off-bed activity, liver function, or postoperative hospital stay.","['50 patients who were scheduled for', 'patients undergoing hepatic resection']","['selective laparoscopic hepatectomy', 'BD-TAP block', 'Ultrasound-Guided Bilateral Dual Transversus Abdominis Plane (BD-TAP', 'ropivacaine diluted to 60 mL) with general anesthesia were categorized into the BD-TAP block', 'ropivacaine', 'Laparoscopic Hepatectomy', 'ultrasound-guided BD-TAP block', 'transversus abdominis plane (TAP) block']","['visual analog scale (VAS) scores on coughing', 'postoperative sufentanil consumption', 'postoperative nausea and/or vomiting, flatus, catheter removal, off-bed activity, liver function, or postoperative hospital stay', 'consumption of sufentanil within 48 hours post-operation and plasma ropivacaine concentration', 'mean free ropivacaine concentration', 'safety and efficacy', 'severity of pain (at rest and upon coughing), nausea and/or vomiting, and quality of recovery', 'mean peak total ropivacaine concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0224378', 'cui_str': 'Structure of transversus abdominis muscle'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0826301,"There were no statistically significant differences in postoperative nausea and/or vomiting, flatus, catheter removal, off-bed activity, liver function, or postoperative hospital stay.","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Tieshuai', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ""Department of Anesthesiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Fei', 'Affiliation': ""Department of Anesthesiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': ""Department of Anesthesiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, People's Republic of China.""}]","Drug design, development and therapy",['10.2147/DDDT.S255385']
1865,32764898,A Randomized Controlled Trial of FNB versus FICB for Patients with Femoral Neck Fractures Before Spinal Anesthesia.,"Background and Objectives


Patients with femoral neck fractures often suffer severe pain. This randomized controlled clinical study compared the effect of femoral nerve block (FNB) and fascia iliaca compartment block (FICB) in this population.
Patients and Methods


Forty-six patients were randomly assigned to one of the two groups: FNB group (femoral nerve block, n=23) or FICB group (fascia iliaca compartment block, n=23). Before positioning for spinal anesthesia, patients received FNB with 15 mL of 0.5% ropivacaine or FICB with 40 mL of 0.5% ropivacaine. Pain was evaluated using a visual analogue scale (VAS) at rest and during hip flexion after admission to the operation room; at 3, 5, 8, and 10 min after analgesia intervention; and during positioning for spinal anesthesia. Positioning was attempted after 10 min of analgesia intervention in each group. Time required to perform spinal anesthesia, quality of positioning, and patient satisfaction were documented.
Results


The VAS scores in the FNB group were significantly lower than those in FICB group at 3 and 5 min after analgesia intervention (P=0.000). However, there were no significant differences in VAS between groups at 8 or 10 min or during positioning.
Conclusion


FNB and FICB produce similar analgesic effects in patients with femoral neck fractures, but FNB has a more rapid onset of pain relief.",2020,The VAS scores in the FNB group were significantly lower than those in FICB group at 3 and 5 min after analgesia intervention (P=0.000).,"['Patients with Femoral Neck Fractures Before Spinal Anesthesia', 'Patients and Methods\n\n\nForty-six patients', 'patients with femoral neck fractures', 'Patients with femoral neck fractures often suffer severe pain']","['ropivacaine', 'femoral nerve block (FNB) and fascia iliaca compartment block (FICB', 'FICB', 'FNB group (femoral nerve block, n=23) or FICB group (fascia iliaca compartment block', 'FNB and FICB', 'FNB', 'FNB with 15 mL of 0.5% ropivacaine or FICB']","['analgesic effects', 'VAS', 'visual analogue scale (VAS', 'Pain', 'Time required to perform spinal anesthesia, quality of positioning, and patient satisfaction', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block'}, {'cui': 'C0225261', 'cui_str': 'Iliac fascia structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",46.0,0.104019,The VAS scores in the FNB group were significantly lower than those in FICB group at 3 and 5 min after analgesia intervention (P=0.000).,"[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': ""Department of Anesthesiology, The\u2009Affiliated\u2009Hospital\u2009of\u2009Guilin\u2009Medical\u2009University, Guilin, People's Republic of China.""}, {'ForeName': 'Lv', 'Initials': 'L', 'LastName': 'Lv', 'Affiliation': ""Emergency Department, The Affiliated\u2009Hospital\u2009of\u2009Guilin\u2009Medical\u2009University, Guilin, People's Republic of China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'He', 'Affiliation': ""Department of Anesthesiology, The\u2009Affiliated\u2009Hospital\u2009of\u2009Guilin\u2009Medical\u2009University, Guilin, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': ""Department of Anesthesiology, The First Hospital of Jiaxing (Affiliated Hospital of Jiaxing University), Jiaxing, People's Republic of China.""}, {'ForeName': 'Cai', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesiology, The\u2009Affiliated\u2009Hospital\u2009of\u2009Guilin\u2009Medical\u2009University, Guilin, People's Republic of China.""}, {'ForeName': 'Jingjuan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, The\u2009Affiliated\u2009Hospital\u2009of\u2009Guilin\u2009Medical\u2009University, Guilin, People's Republic of China.""}]",Clinical interventions in aging,['10.2147/CIA.S251025']
1866,32764908,Cost-Effectiveness Analysis of a Once-Daily Single-Inhaler Triple Therapy for Patients with Chronic Obstructive Pulmonary Disease (COPD) Using the FULFIL Trial: A Spanish Perspective.,"Purpose


To evaluate the cost-effectiveness of once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) vs twice-daily budesonide/formoterol (BUD/FOR) in patients with symptomatic chronic obstructive pulmonary disease (COPD) at risk of exacerbations, from the Spanish National Healthcare System perspective.
Patients and Methods


The validated GALAXY-COPD model was used to simulate disease progression and predict healthcare costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) over a 3-year time horizon for a Spanish population. Patient characteristics from published literature were supplemented by data from FULFIL (NCT02345161), which compared FF/UMEC/VI vs BUD/FOR in patients with symptomatic COPD at risk of exacerbations. Treatment effects, extrapolated to 3 years, were based on Week 24 results in the FULFIL intent-to-treat population, including change in forced expiratory volume in 1 second, St. George's Respiratory Questionnaire score, and exacerbation rates. Treatment, exacerbations, and COPD management costs (2019€) were informed by Spanish public sources and published literature. A 3% discount rate for costs and benefits was applied. One-way sensitivity and scenario analyses, and probabilistic sensitivity analysis (PSA), were performed.
Results


FF/UMEC/VI treatment led to fewer moderate and severe exacerbations (2.126 and 0.306, respectively) vs BUD/FOR (2.608 and 0.515, respectively), with a mean incremental cost of €69 and gain of 0.107 QALYs, which resulted in an ICER of €642 per QALY gained. In sensitivity analyses, the ICER was most sensitive to treatment effect variations in exacerbations and healthcare resource utilization/event costs. Overall, 95% of 1000 PSA simulations resulted in an ICER less than €11,000 per QALY gained for FF/UMEC/VI vs BUD/FOR, confirming robustness of the results. The probability of FF/UMEC/VI being cost-effective vs BUD/FOR was 100% at a willingness-to-pay threshold of €30,000 per QALY gained.
Conclusion


At the accepted Spanish ICER threshold of €30,000, FF/UMEC/VI represents a cost-effective treatment option vs BUD/FOR in patients with symptomatic COPD at risk of exacerbations.",2020,"In sensitivity analyses, the ICER was most sensitive to treatment effect variations in exacerbations and healthcare resource utilization/event costs.","['patients with symptomatic chronic obstructive pulmonary disease (COPD) at risk of exacerbations, from the Spanish National Healthcare System perspective', 'Patients with Chronic Obstructive Pulmonary Disease (COPD', 'patients with symptomatic COPD at risk of exacerbations']","['Once-Daily Single-Inhaler Triple Therapy', 'fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) vs twice-daily budesonide/formoterol (BUD/FOR']","['healthcare costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs', 'moderate and severe exacerbations', 'Treatment, exacerbations, and COPD management costs', 'cost-effectiveness', ""forced expiratory volume in 1 second, St. George's Respiratory Questionnaire score, and exacerbation rates"", 'probability of FF/UMEC/VI being cost-effective vs BUD/FOR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}]","[{'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}]","[{'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C3472502', 'cui_str': ""Saint George's respiratory questionnaire score""}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}]",,0.272579,"In sensitivity analyses, the ICER was most sensitive to treatment effect variations in exacerbations and healthcare resource utilization/event costs.","[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Schroeder', 'Affiliation': 'Value Evidence and Outcomes, GlaxoSmithKline plc., Brentford, UK.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Benjamin', 'Affiliation': 'Global Health Economics, ICON plc., Boston, MA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Atienza', 'Affiliation': 'Market Access, GlaxoSmithKline SA, Madrid, Spain.'}, {'ForeName': 'Chandroday', 'Initials': 'C', 'LastName': 'Biswas', 'Affiliation': 'Global Health Economics, ICON plc., Bengaluru, Karnataka, India.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Value Evidence and Outcomes, GlaxoSmithKline plc., Uxbridge, UK.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Whalen', 'Affiliation': 'Global Health Economics, ICON plc., Abingdon, UK.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Izquierdo Alonso', 'Affiliation': 'Pneumology, Hospital Universitario de Guadalajara, Guadalajara, Spain.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'Riesco Miranda', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Servicio de Neumología, Hospital San Pedro de Alcántara, Cáceres, Spain.'}, {'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'Soler-Cataluña', 'Affiliation': 'Pneumology Department, Hospital Arnau de Vilanova-Lliria (Valencia), Valencia, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Huerta', 'Affiliation': 'Market Access, GlaxoSmithKline SA, Madrid, Spain.'}, {'ForeName': 'Afisi S', 'Initials': 'AS', 'LastName': 'Ismaila', 'Affiliation': 'Value Evidence and Outcomes, GlaxoSmithKline plc., Collegeville, PA, USA.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S240556']
1867,32764918,The Summit Score Stratifies Mortality and Morbidity in Chronic Obstructive Pulmonary Disease.,"Introduction


Tobacco use and other cardiovascular risk factors often accompany chronic obstructive pulmonary disease (COPD). This study derived and validated the Summit Score to predict mortality in people with COPD and cardiovascular risks.
Methods


SUMMIT trial subjects (N=16,485) ages 40-80 years with COPD were randomly assigned 50%/50% to derivation (N=8181) and internal validation (N=8304). Three external COPD validations from Intermountain Healthcare included outpatients with cardiovascular risks (N=9251), outpatients without cardiovascular risks (N=8551), and inpatients (N=26,170). Cox regression evaluated 40 predictors of all-cause mortality. SUMMIT treatments including combined fluticasone furoate (FF) 100μg/vilanterol 25μg (VI) were not included in the score.
Results


Mortality predictors were FEV 1 , heart rate, systolic blood pressure, body mass index, age, smoking pack-years, prior COPD hospitalizations, myocardial infarction, heart failure, diabetes, anti-thrombotics, anti-arrhythmics, and xanthines. Combined in the Summit Score (derivation: c=0.668), quartile 4 vs 1 had HR=4.43 in SUMMIT validation (p<0.001, 95% CI=3.27, 6.01, c=0.662) and HR=8.15 in Intermountain cardiovascular risk COPD outpatients (p<0.001, 95% CI=5.86, 11.34, c=0.736), and strongly predicted mortality in the other Intermountain COPD populations. Among all SUMMIT subjects with scores 14-19, FF 100μg/VI 25μg vs placebo had HR=0.76 (p=0.0158, 95% CI=0.61, 0.95), but FF 100μg/VI 25μg was not different from placebo for scores <14 or >19.
Conclusion


In this post hoc analysis of SUMMIT trial data, the Summit Score was derived and validated in multiple Intermountain COPD populations. The score was used to identify a subpopulation in which mortality risk was lower for FF 100μg/VI 25μg treatment.
Trial Registration


The SUMMIT trial is registered at ClinicalTrials.gov as number NCT01313676.",2020,"Combined in the Summit Score (derivation: c=0.668), quartile 4 vs 1 had HR=4.43 in SUMMIT validation (p<0.001, 95% CI=3.27, 6.01, c=0.662) and HR=8.15 in Intermountain cardiovascular risk COPD outpatients (p<0.001, 95% CI=5.86, 11.34, c=0.736), and strongly predicted mortality in the other Intermountain COPD populations.","['people with COPD and cardiovascular risks', 'outpatients with cardiovascular risks (N=9251), outpatients without cardiovascular risks (N=8551), and inpatients (N=26,170', 'accompany chronic obstructive pulmonary disease (COPD', 'Chronic Obstructive Pulmonary Disease', 'Methods\n\n\nSUMMIT trial subjects (N=16,485) ages 40-80 years with COPD']","['fluticasone furoate', 'placebo']","['Summit Score Stratifies Mortality and Morbidity', 'mortality risk', 'FEV 1 , heart rate, systolic blood pressure, body mass index, age, smoking pack-years, prior COPD hospitalizations, myocardial infarction, heart failure, diabetes, anti-thrombotics, anti-arrhythmics, and xanthines']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0043314', 'cui_str': 'xanthine'}]",3.0,0.500894,"Combined in the Summit Score (derivation: c=0.668), quartile 4 vs 1 had HR=4.43 in SUMMIT validation (p<0.001, 95% CI=3.27, 6.01, c=0.662) and HR=8.15 in Intermountain cardiovascular risk COPD outpatients (p<0.001, 95% CI=5.86, 11.34, c=0.736), and strongly predicted mortality in the other Intermountain COPD populations.","[{'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Horne', 'Affiliation': 'Intermountain Medical Center Heart Institute, Salt Lake City, UT, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Hegewald', 'Affiliation': 'Division of Pulmonary Medicine, Department of Internal Medicine, Intermountain Medical Center, Salt Lake City, UT, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Crim', 'Affiliation': 'Research and Development, GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Rea', 'Affiliation': 'Care Transformation, Intermountain Healthcare, Salt Lake City, UT, USA.'}, {'ForeName': 'Tami L', 'Initials': 'TL', 'LastName': 'Bair', 'Affiliation': 'Intermountain Medical Center Heart Institute, Salt Lake City, UT, USA.'}, {'ForeName': 'Denitza P', 'Initials': 'DP', 'LastName': 'Blagev', 'Affiliation': 'Division of Pulmonary Medicine, Department of Internal Medicine, Intermountain Medical Center, Salt Lake City, UT, USA.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S254437']
1868,32765023,Effect of Different Volumes of Interval Training and Continuous Exercise on Interleukin-22 in Adults with Metabolic Syndrome: A Randomized Trial.,"Introduction


IL-22 may have a role in the alleviation of the metabolic syndrome (MetS) via protection of pancreatic beta and endothelial cells from oxidative and lipid-induced damage. We aimed to investigate the effects of moderate-intensity continuous training (MICT) and different volumes of high-intensity interval training (HIIT) on changes in circulating IL-22.
Methods


This was a sub-study of the ""Exercise in the prevention of Metabolic Syndrome"" (EX-MET) a multi-center, randomized trial. This study used data collected at the Brisbane site. Thirty-nine individuals with MetS were randomized to one of three 16-wk interventions: 1) MICT (n=10, 30min at 60-70% HR peak, 5x/wk); 2) 4HIIT (n=13, 4x4min at 85-95% HR peak, interspersed with 3min of active recovery at 50-70% HR peak, 3x/wk); or 3) 1HIIT (n=16, 1x4min at 85-95% HR peak, 3x/wk). Serum IL-22 concentration was measured following a 12-hr fast via an enzyme linked immunosorbent assay, before and after the intervention. MetS severity, insulin resistance (IR), visceral adipose tissue (VAT), and cardiorespiratory fitness (CRF) were also measured via MetS z-score, HOMA-IR, dual-energy X-ray absorptiometry, and indirect calorimetry (maximal exercise test), respectively.
Results


The median (IQR) IL-22% changes from pre- to post-intervention in the MICT, 4HIIT, and 1HIIT groups were -17% (-43.0% to 31.3%), +16.5% (-18.9% to 154.9%), and +15.9% (-28.7% to 46.1%), respectively. Although there were no significant between-group differences in IL-22 concentration change, there was a medium-to-large group × time interaction effect [F(2,35)=2.08, p=0.14, η 2 =0.14].
Conclusion


Although there was no statistically significant between-group difference in IL-22 change, the study suggests that different exercise intensities may have opposing effects on IL-22 concentration in individuals with MetS.",2020,"Although there was no statistically significant between-group difference in IL-22 change, the study suggests that different exercise intensities may have opposing effects on IL-22 concentration in individuals with MetS.","['Adults with Metabolic Syndrome', 'individuals with MetS', 'Thirty-nine individuals with MetS']","['Interval Training and Continuous Exercise', 'Exercise', 'MICT', '4HIIT', 'moderate-intensity continuous training (MICT) and different volumes of high-intensity interval training (HIIT']","['median (IQR) IL-22', 'IL-22 concentration change', 'MetS severity, insulin resistance (IR), visceral adipose tissue (VAT), and cardiorespiratory fitness (CRF', 'IL-22 concentration', 'MetS z-score, HOMA-IR, dual-energy X-ray absorptiometry, and indirect calorimetry (maximal exercise test', 'Serum IL-22 concentration', 'IL-22 change']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816447', 'cui_str': '39'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0961814', 'cui_str': 'interleukin-22'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0010132', 'cui_str': 'Corticotropin-Releasing Hormone'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.0962552,"Although there was no statistically significant between-group difference in IL-22 change, the study suggests that different exercise intensities may have opposing effects on IL-22 concentration in individuals with MetS.","[{'ForeName': 'Joyce S', 'Initials': 'JS', 'LastName': 'Ramos', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Lance C', 'Initials': 'LC', 'LastName': 'Dalleck', 'Affiliation': 'Caring Futures Institute and SHAPE Research Centre, Exercise Science and Clinical Exercise Physiology, College of Nursing and Health Sciences, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Rebecca C', 'Initials': 'RC', 'LastName': 'Stennett', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Gregore I', 'Initials': 'GI', 'LastName': 'Mielke', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Shelley E', 'Initials': 'SE', 'LastName': 'Keating', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Murray', 'Affiliation': 'Immunopathology Group, Mater Research Institute - The University of Queensland, Translational Research Institute, Brisbane, Queensland, Australia.'}, {'ForeName': 'Sumaira Z', 'Initials': 'SZ', 'LastName': 'Hasnain', 'Affiliation': 'Immunopathology Group, Mater Research Institute - The University of Queensland, Translational Research Institute, Brisbane, Queensland, Australia.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Fassett', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McGuckin', 'Affiliation': 'Immunopathology Group, Mater Research Institute - The University of Queensland, Translational Research Institute, Brisbane, Queensland, Australia.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Croci', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Coombes', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}]","Diabetes, metabolic syndrome and obesity : targets and therapy",['10.2147/DMSO.S251567']
1869,32765075,A New Surgical Technique of Combination Retroperitoneal with Transperitoneal Laparoscopic Nephroureterectomy in a Single Position and Comparative Outcomes.,"Background


The traditional surgical treatment for upper urinary tract urothelial carcinoma (UTUC) is time-consuming owing to changing the surgical position and larger surgical trauma because of open surgery in handling the distal ureter. Therefore, we created a new surgical technique of combination retroperitoneal with transperitoneal (CRT) laparoscopic nephroureterectomy (LNU) in a single position and here report our early outcomes.
Methods


From January 2017 to December 2019, a total of 106 patients underwent LNU by a single surgeon at our department, of whom 50 patients underwent standard technique and 56 patients underwent CRT technique. Relevant clinical data were collected including each patient's characteristics, surgical outcomes, and follow-up results. A comparative analysis between standard LNU cases and CRT LNU cases was performed.
Results


LNU was performed successfully on all 106 patients. There was no significant difference in patients' characteristics. Compared to the standard group, patients in the CRT group had shorter operative time ( P =0.001), less estimated blood loss (EBL) ( P <0.001), lower visual analogue scale (VAS) pain score ( P =0.020) and less scarring ( P =0.013). The median time of surgical drain stay decreased from 5 to 2 days ( P =0.004) and median hospital stay after surgery decreased from 5 to 3 days ( P =0.001). The complication rates did not show statistical differences between the two groups within the first 30 days postoperatively ( P =0.263). For the long-term complications, the incidence of abdomen bulge or incisional hernia in the CRT group was less than that in the standard group ( P <0.001).
Conclusion


The CRT technique, which combines both the advantages of retroperitoneal and transperitoneal approaches, is a more minimally invasive, simplified and effective way to perform the LNU.",2020,"Compared to the standard group, patients in the CRT group had shorter operative time ( P =0.001), less estimated blood loss (EBL) ( P <0.001), lower visual analogue scale (VAS) pain score ( P =0.020) and less scarring ( P =0.013).","['From January 2017 to December 2019, a total of 106 patients underwent LNU by a single surgeon at our department, of whom 50 patients underwent standard technique and 56 patients underwent', 'upper urinary tract urothelial carcinoma (UTUC']","['combination retroperitoneal with transperitoneal (CRT) laparoscopic nephroureterectomy (LNU', 'Transperitoneal Laparoscopic Nephroureterectomy', 'CRT technique']","['complication rates', 'median time of surgical drain stay', 'incidence of abdomen bulge or incisional hernia', 'scarring', 'lower visual analogue scale (VAS) pain score', 'estimated blood loss (EBL', 'median hospital stay', 'shorter operative time']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2111394', 'cui_str': 'Laparoscopic nephroureterectomy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1508753', 'cui_str': 'Urinary system structure'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}]","[{'cui': 'C0035359', 'cui_str': 'Retroperitoneal'}, {'cui': 'C0205501', 'cui_str': 'Transperitoneal approach'}, {'cui': 'C2111394', 'cui_str': 'Laparoscopic nephroureterectomy'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2607832', 'cui_str': 'Surgical drain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",106.0,0.0287389,"Compared to the standard group, patients in the CRT group had shorter operative time ( P =0.001), less estimated blood loss (EBL) ( P <0.001), lower visual analogue scale (VAS) pain score ( P =0.020) and less scarring ( P =0.013).","[{'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': ""Department of Urology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Wenkuan', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department of Urology, Beijing Haidian Hospital/Haidian Hospital of Beijing University Third Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Qinxin', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': ""Department of Urology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Yuhong', 'Initials': 'Y', 'LastName': 'Wen', 'Affiliation': ""Department of Urology, Huhehaote First Hospital, Inner Mongolia, People's Republic of China.""}, {'ForeName': 'Xiaoguang', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': ""Department of Urology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Han', 'Affiliation': ""Department of Urology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Urology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, People's Republic of China.""}]",Cancer management and research,['10.2147/CMAR.S259964']
1870,32765139,"Enhancing Slow Oscillations and Increasing N3 Sleep Proportion with Supervised, Non-Phase-Locked Pink Noise and Other Non-Standard Auditory Stimulation During NREM Sleep.","Purpose


In non-rapid eye movement (NREM) stage 3 sleep (N3), phase-locked pink noise auditory stimulation can amplify slow oscillatory activity (0.5-1 Hz). Open-loop pink noise auditory stimulation can amplify slow oscillatory and delta frequency activity (0.5-4 Hz). We assessed the ability of pink noise and other sounds to elicit delta power, slow oscillatory power, and N3 sleep.
Participants and Methods


Participants ( n  = 8) underwent four consecutive inpatient nights in a within-participants design, starting with a habituation night. A registered polysomnographic technologist live-scored sleep stage and administered stimuli on randomized counterbalanced Enhancing and Disruptive nights, with a preceding Habituation night (night 1) and an intervening Sham night (night 3). A variety of non-phase-locked pink noise stimuli were used on Enhancing night during NREM; on Disruptive night, environmental sounds were used throughout sleep to induce frequent auditory-evoked arousals.
Results


Total sleep time did not differ between conditions. Percentage of N3 was higher in the Enhancing condition, and lower in the Disruptive condition, versus Sham. Standard 0.8 Hz pink noise elicited low-frequency power more effectively than other pink noise, but was not the most effective stimulus. Both pink noise on the ""Enhancing"" night and sounds intended to Disrupt sleep administered on the ""Disruptive"" night increased momentary delta and slow-wave activity (ie, during stimulation versus the immediate pre-stimulation period). Disruptive auditory stimulation degraded sleep with frequent arousals and increased next-day vigilance lapses versus Sham despite preserved sleep duration and momentary increases in delta and slow-wave activity.
Conclusion


These findings emphasize sound features of interest in ecologically valid, translational auditory intervention to increase restorative sleep. Preserving sleep continuity should be a primary consideration if auditory stimulation is used to enhance slow-wave activity.",2020,"Disruptive auditory stimulation degraded sleep with frequent arousals and increased next-day vigilance lapses versus Sham despite preserved sleep duration and momentary increases in delta and slow-wave activity.
",[],"['Open-loop pink noise auditory stimulation', 'polysomnographic technologist live-scored sleep stage and administered stimuli on randomized counterbalanced Enhancing and Disruptive nights, with a preceding Habituation night (night 1) and an intervening Sham night (night 3']","['ability of pink noise and other sounds to elicit delta power, slow oscillatory power, and N3 sleep', 'sleep duration and momentary increases in delta and slow-wave activity', 'momentary delta and slow-wave activity', 'Total sleep time', 'restorative sleep']",[],"[{'cui': 'C0559530', 'cui_str': 'Open loop'}, {'cui': 'C0332585', 'cui_str': 'Pink color'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0001164', 'cui_str': 'Stimulation, Acoustic'}, {'cui': 'C0260280', 'cui_str': 'Technologist'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0037319', 'cui_str': 'Sleep Stages'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013170', 'cui_str': 'Drug habituation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0332585', 'cui_str': 'Pink color'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0858603', 'cui_str': 'Wave slowing'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0240526,"Disruptive auditory stimulation degraded sleep with frequent arousals and increased next-day vigilance lapses versus Sham despite preserved sleep duration and momentary increases in delta and slow-wave activity.
","[{'ForeName': 'Margeaux M', 'Initials': 'MM', 'LastName': 'Schade', 'Affiliation': 'Biobehavioral Health, Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Gina Marie', 'Initials': 'GM', 'LastName': 'Mathew', 'Affiliation': 'Biobehavioral Health, Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Roberts', 'Affiliation': 'Proactive Life, Inc., New York, NY, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gartenberg', 'Affiliation': 'Proactive Life, Inc., New York, NY, USA.'}, {'ForeName': 'Orfeu M', 'Initials': 'OM', 'LastName': 'Buxton', 'Affiliation': 'Biobehavioral Health, Pennsylvania State University, University Park, PA, USA.'}]",Nature and science of sleep,['10.2147/NSS.S243204']
1871,32765143,"Comparison of Morning and Evening Operation Under General Anesthesia on Intraoperative Anesthetic Requirement, Postoperative Sleep Quality, and Pain: A Randomized Controlled Trial.","Objective


Postoperative sleep disorders can cause serious adverse effects on postoperative outcomes. The purpose of our study was to compare the effects of the timing of surgery under general anesthesia on intraoperative anesthetic drug requirements, postoperative sleep quality and pain in patients.
Materials and Methods


Eighty-four patients who underwent selective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to the Day Group (8:00-12:00) or the Night Group (18:00-22:00). The portable sleep monitor (PSM) was used to determine sleep quality on the night before surgery (Sleep-preop), the first night after surgery (Sleep POD 1), and the third night after surgery (Sleep POD 3). The visual analog scale (VAS) was used to evaluate postoperative pain scores and the Athens Insomnia Scale (AIS) was used for assessing insomnia symptoms. The total dose of general anesthetics required and adverse effects after surgery were also assessed.
Results


Compared to Sleep-preop, patients presented with a lower sleep efficiency and a higher AIS score during Sleep POD 1 and Sleep POD 3. Furthermore, the Night Group had a significantly lower proportion of rapid eye movement sleep, stable sleep, and unstable sleep than did the Day Group at Sleep POD 1 and Sleep POD 3. The dosage of propofol and remifentanil required in the Day Group was significantly higher than that in the Night Group. Furthermore, patients in the Day Group had better pain relief, with a lower VAS score at 1, 6, 12, and 24 hours after surgery. The incidences of postoperative nausea and vomiting and dizziness were significantly higher in the Night Group than those in the Day Group.
Conclusion


Morning operations required a higher dose of anesthetic drugs than did evening operations, which may be related to the circadian rhythm. The degree of postoperative sleep disorders was greater when the operation was performed in the evening than in the morning, which was also associated with increased pain perception and increased incidence of postoperative adverse effects. Thus, our results suggest that patients with hyperalgesia and sleep disorders may benefit from operations performed in the morning.",2020,The dosage of propofol and remifentanil required in the Day Group was significantly higher than that in the Night Group.,"['patients', 'patients with hyperalgesia and sleep disorders', 'Materials and Methods\n\n\nEighty-four patients who underwent selective laparoscopic abdominal surgeries under general anesthesia']","['surgery under general anesthesia', 'portable sleep monitor (PSM', 'propofol and remifentanil', 'Morning and Evening Operation Under General Anesthesia']","['postoperative sleep quality and pain', 'postoperative pain scores and the Athens Insomnia Scale (AIS', 'pain relief', 'visual analog scale (VAS', 'VAS score', 'postoperative nausea and vomiting and dizziness', 'degree of postoperative sleep disorders', 'postoperative adverse effects', 'Intraoperative Anesthetic Requirement, Postoperative Sleep Quality, and Pain', 'pain perception', 'rapid eye movement sleep, stable sleep, and unstable sleep']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0587117', 'cui_str': 'Evening'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0037322', 'cui_str': 'Rapid eye movement sleep'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443343', 'cui_str': 'Unstable status'}]",84.0,0.0391005,The dosage of propofol and remifentanil required in the Day Group was significantly higher than that in the Night Group.,"[{'ForeName': 'Bijia', 'Initials': 'B', 'LastName': 'Song', 'Affiliation': ""Department of Anesthesiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Xiufei', 'Initials': 'X', 'LastName': 'Teng', 'Affiliation': ""Department of Anesthesiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Xiuyan', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Yanchao', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Anesthesiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Junchao', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': ""Department of Anesthesiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}]",Nature and science of sleep,['10.2147/NSS.S257896']
1872,32765146,Efficacy of Electroacupuncture on Treating Depression-Related Insomnia: A Randomized Controlled Trial.,"Objective


To evaluate the efficacy of electroacupuncture (EA) on treating insomnia in patients with depression.
Patients and Methods


In a patient-assessor-blind, randomized and sham controlled trial, 90 depression patients with insomnia were assigned into three different groups, receiving EA in the treatment group, superficial acupuncture at sham points in the control group A, or Streitberger non-insertion sham acupuncture in the control group B. Treatment was applied 3 times weekly for 8 consecutive weeks. The primary outcome was measured using the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes were sleep parameters including sleep efficiency (SE), total sleep time (TST) and numbers of sleep awakenings (SA) recorded in the actigraphy, as well as applying the Hamilton Rating Scale for Depression (HAMD-17), Self-Rating Depression Scale (SDS) and Hamilton Rating Scale for Anxiety (HAMA). Assessments were performed at the baseline (week 0), week 4, week 8, and week 12. Linear mixed-effects models were used for analyses and all statistical tests were two-sided.
Results


Patients in the EA group had more significant improvement in PSQI scores than those in the control groups over time (respectively  p <0.001 and  p =0.04 for treatment and time interaction). At 8-week posttreatment, the EA group reported a reduction of -6.64 points in PSQI scores compared with -2.23 points in the control group A (95% CI= -5.74 to -2.39) and -2.94 points in the control group B (95% CI= -5.73 to -2.47). Compared with the two control groups, significant between-group differences were seen in SE (both  p <0.01) and TST (both  p <0.01) at week 8; similar results can be found in HAMD-17, SDS, and HAMA scores as well. However, there were no between-group differences in SA (respectively  p =0.24 and  p =0.08) after 8-weeks of treatment.
Conclusion


Electroacupuncture may improve the sleep quality of patients with depression.
Trial Registration


Chinese Clinical Trial Registry (ChiCTR); URL: http://www.chictr.org.cn/showproj.aspx?proj=12327; Trial ID: ChiCTR-IIR-16008058.",2020,"Compared with the two control groups, significant between-group differences were seen in SE (both  p <0.01) and TST (both  p <0.01) at week 8; similar results can be found in HAMD-17, SDS, and HAMA scores as well.","['patients with depression', '90 depression patients with insomnia', 'Treating Depression-Related Insomnia']","['electroacupuncture (EA', 'Electroacupuncture', 'superficial acupuncture at sham points in the control group A, or Streitberger non-insertion sham acupuncture']","['SE', 'sleep parameters including sleep efficiency (SE), total sleep time (TST) and numbers of sleep awakenings (SA) recorded in the actigraphy, as well as applying the Hamilton Rating Scale for Depression (HAMD-17), Self-Rating Depression Scale (SDS) and Hamilton Rating Scale for Anxiety (HAMA', 'HAMD-17, SDS, and HAMA scores', 'Pittsburgh Sleep Quality Index (PSQI', 'PSQI scores', 'TST', 'SA', 'sleep quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",90.0,0.0801643,"Compared with the two control groups, significant between-group differences were seen in SE (both  p <0.01) and TST (both  p <0.01) at week 8; similar results can be found in HAMD-17, SDS, and HAMA scores as well.","[{'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Yin', 'Affiliation': ""Department of Acupuncture and Moxibustion, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Department of Acupuncture and Moxibustion, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, People's Republic of China.""}, {'ForeName': 'Huangan', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ""Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Dong', 'Affiliation': ""Department of Acupuncture and Moxibustion, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, People's Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': ""Department of Acupuncture and Moxibustion, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, People's Republic of China.""}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Department of Acupuncture and Moxibustion, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, People's Republic of China.""}, {'ForeName': 'Lixing', 'Initials': 'L', 'LastName': 'Lao', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Shifen', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': ""Department of Acupuncture and Moxibustion, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, People's Republic of China.""}]",Nature and science of sleep,['10.2147/NSS.S253320']
1873,32765322,Short-Term and Highly Intensive Early Intervention FIAS: Two-Year Outcome Results and Factors of Influence.,"Background


Comprehensive behaviorally or developmentally based early intervention programs have been shown to be effective in improving cognitive, social communicative, and adaptive skills of children with autism spectrum disorder (ASD). Besides the definition of relevant outcome predictors, the question of whether early intensive intervention positively changes core autism symptoms in children, as well as their long-term outcome, is an important issue for current research. The primary objective of the current study was to examine whether symptomatic and behavioral changes in children up to 4.5 years with ASD were sustained one and two years after an initial 18 days of intensive FIAS (Frühintervention bei autistischen Störungen) intervention.
Methods


We analyzed the data of 32 young children with moderately severe to severe ASD who had been treated at the FIAS center between January 2011 and July 2017 and who had completed their 2-year follow-up in summer 2019.
Results


ADOS total scores decreased significantly from baseline to the 1-year follow-up and from baseline to the 2-year follow-up (p < 0.01), with the most prominent change being from baseline to 2-year follow-up. The DD-C-GAS, a global scale used to assess four areas of everyday functioning, showed highly significant improvements on all subdomains. We found mostly significant correlations between results on both rating instruments at all time points, yet mostly no meaningful correlation between their changes over time. There was a close and statistically significant relationship between parents' treatment adherence and ADOS scores, indicating that the better parents' treatment adherence, the lower the children scored on the ADOS at 1- and 2-year follow-up. Overall, improvement on both scales was virtually independent of age and autism symptom severity at baseline, suggesting that older (>43 months) and more severely affected children (ADOS total score >20) may benefit from the FIAS intervention to the same extent as younger children do.
Conclusions


The results of the study indicate that the FIAS approach of providing an initial highly intensive 18-day intervention period, followed by 2 years of less intensive follow-up care had an impact on the core autism symptoms as well as the adaptive functioning of children with ASD.",2020,"The DD-C-GAS, a global scale used to assess four areas of everyday functioning, showed highly significant improvements on all subdomains.","['children with ASD', 'children up to 4.5 years with ASD', 'children with autism spectrum disorder (ASD', '32 young children with moderately severe to severe ASD who had been treated at the FIAS center between January 2011 and July 2017 and who had completed their 2-year follow-up in summer 2019']","['Short-Term and Highly Intensive Early Intervention', 'intensive FIAS (Frühintervention bei autistischen Störungen) intervention', 'FIAS']","[""parents' treatment adherence and ADOS scores"", 'ADOS total scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0180917', 'cui_str': 'Fluorescence immunoassay analyzer'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0180917', 'cui_str': 'Fluorescence immunoassay analyzer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",32.0,0.0278198,"The DD-C-GAS, a global scale used to assess four areas of everyday functioning, showed highly significant improvements on all subdomains.","[{'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Herbrecht', 'Affiliation': 'Child and Adolescent Psychiatry, Psychiatric University Hospitals, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Lazari', 'Affiliation': 'Child and Adolescent Psychiatry, Psychiatric University Hospitals, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Notter', 'Affiliation': 'Child and Adolescent Psychiatry, Psychiatric University Hospitals, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Kievit', 'Affiliation': 'Child and Adolescent Psychiatry, Psychiatric University Hospitals, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Schmeck', 'Affiliation': 'Child and Adolescent Psychiatry, Psychiatric University Hospitals, University of Basel, Basel, Switzerland.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Spiegel', 'Affiliation': 'Child and Adolescent Psychiatry, Psychiatric University Hospitals, University of Basel, Basel, Switzerland.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00687']
1874,32765344,Contracting Students for the Reduction of Foreign Language Classroom Anxiety: An Approach Nurturing Positive Mindsets and Behaviors.,"The quasi-experimental study reported in this paper investigated whether contracting students' speaking in the foreign language (FL) classroom could effectively mitigate their FL classroom anxiety. It also explored the working mechanisms of this approach to the reduction of classroom anxiety and examined the attitudes FL students had toward it. To these ends, 42 Chinese-as-the-first-language university students learning English as a foreign language (EFL) were recruited and placed into the experimental ( n  = 20) and comparison groups ( n  = 22). Both groups were tested for anxiety before and after completing a 1-week contract and a non-contracting treatment, respectively. The experimental group participants' diaries were also collected, and their attitudes toward the intervention were elicited. Results showed that the experimental group's level of anxiety decreased significantly more as compared with that of the comparison group, suggesting the better efficacy of contracting speaking in FL anxiety reduction. Diary analyses also suggested that contracting speaking could increase learners' FL learning engagement; enhance their self-efficacy; facilitate their self-reflection of weaknesses and strengths as an FL learner; cultivate their character strengths and positive emotions; and diminish their fear, nervousness, and worries in class. Furthermore, the experimental group participants generally did not feel uncomfortable with the intervention. These findings were discussed in relation to classroom pedagogy for more effective delivery of FL education.",2020,"Results showed that the experimental group's level of anxiety decreased significantly more as compared with that of the comparison group, suggesting the better efficacy of contracting speaking in FL anxiety reduction.","['42 Chinese-as-the-first-language university students learning English as a foreign language (EFL', 'Contracting Students for the Reduction of Foreign Language Classroom Anxiety']",[],"['level of anxiety', 'fear, nervousness, and worries in class']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0557073', 'cui_str': 'First language'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0376327', 'cui_str': 'Multinational Aspects'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",[],"[{'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0456387', 'cui_str': 'Class'}]",,0.01231,"Results showed that the experimental group's level of anxiety decreased significantly more as compared with that of the comparison group, suggesting the better efficacy of contracting speaking in FL anxiety reduction.","[{'ForeName': 'Yinxing', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'School of Foreign Languages, Hainan Normal University, Haikou, China.'}, {'ForeName': 'Lawrence Jun', 'Initials': 'LJ', 'LastName': 'Zhang', 'Affiliation': 'Faculty of Education and Social Work, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'MacIntyre', 'Affiliation': 'Department of Psychology, Cape Breton University, Sydney, NS, Canada.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01471']
1875,32765384,The Use of Virtual Reality Alone Does Not Promote Training Performance (but Sense of Presence Does).,"Virtual reality (VR) offers novel ways to develop skills and learning. This technology can be used to enhance the way we educate and train professionals by possibly being more effective, cost-efficient, and reducing training-related risks. However, the potential benefits from virtual training assume that the trained skills can be transferred to the real world. Nevertheless, in the current published scientific literature, there is limited empirical evidence that links VR use to better learning. The present investigation aimed to explore the use of VR as a tool for training procedural skills and compare this modality with traditional instruction methods. To investigate skill development using the two forms of training, participants were randomly divided into two groups. The first group received training through an instructional video, while the second group trained in VR. After the training session, the participants performed the trained task in a real setting, and task performance was measured. Subsequently, the user's experienced sense of presence and simulator sickness (SS) was measured with self-report questionnaires. There were no significant differences between groups for any of the performance measures. There was no gender effect on performance. Importantly, the results of the present study indicate that a high sense of presence during the VR simulation might contribute to increased skill learning. These findings can be used as a starting point that could be of value when further exploring VR as a tool for skill development.",2020,"This technology can be used to enhance the way we educate and train professionals by possibly being more effective, cost-efficient, and reducing training-related risks.",[],"['Virtual Reality Alone', 'training through an instructional video, while the second group trained in VR', 'Virtual reality (VR']","['performance', 'skill learning', 'sense of presence and simulator sickness (SS']",[],"[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]",,0.0126431,"This technology can be used to enhance the way we educate and train professionals by possibly being more effective, cost-efficient, and reducing training-related risks.","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Grassini', 'Affiliation': 'Department of Psychology, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Laumann', 'Affiliation': 'Department of Psychology, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Rasmussen Skogstad', 'Affiliation': 'Department of Psychology, Norwegian University of Science and Technology, Trondheim, Norway.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01743']
1876,32765401,The Role of Cerebral Hypoperfusion in Multiple Sclerosis (ROCHIMS) Trial in Multiple Sclerosis: Insights From Negative Results.,"Background:  Accumulating evidence indicates that mitochondrial energy failure is involved in the progressive axonal degeneration in multiple sclerosis (MS). In patients with MS, it has been shown that both levels of N-acetylaspartate (NAA), which is a marker of axonal mitochondrial energy, and cerebral blood flow (CBF) are reduced in cerebral normal appearing white matter (NAWM). The latter is likely due to the vasoconstrictive action of endothelin-1 (ET-1) produced by reactive astrocytes, which is triggered by local proinflammatory cytokines. A preliminary study in patients with MS showed that CBF could be restored to normal values after a single dose of 62.5 mg of the ET-1 antagonist bosentan.  Objective:  To investigate whether restoring CBF in patients with relapsing remitting MS (RRMS) increases levels of NAA in cerebral NAWM and improves clinical symptoms.  Methods:  27 RRMS patients were included in a 4 weeks proof-of-concept, randomized, double-blind placebo-controlled trial (ROCHIMS) to investigate whether bosentan 62.5 mg twice daily could increase the NAA/creatine (NAA/Cr) ratio in NAWM of the centrum semiovale. Magnetic resonance imaging (MRI) assessing CBF and NAA/Cr, and clinical evaluations were performed at baseline and at end of study. Separately from the clinical trial, 10 healthy controls underwent the same baseline multimodal brain MRI protocol as the MS patients.  Results:  Eleven patients in the bosentan arm and thirteen patients in the placebo arm completed the study. Bosentan did not increase CBF. However, we found that CBF in the patients was not different from that of the healthy controls. There were no effects on NAA levels and clinical symptoms.  Conclusions:  Our study showed that CBF in RRMS patients is not always decreased and that bosentan has no effect when CBF values are within the normal range. We hypothesize that in our patients there was no significant astrocytic production of ET-1 because they had a mild disease course, with minimal local inflammatory activity. Future studies with bosentan in MS should focus on patients with elevated ET-1 levels in cerebrospinal fluid or blood.",2020,There were no effects on NAA levels and clinical symptoms.  ,"['10 healthy controls underwent the same baseline multimodal brain MRI protocol as the MS patients', '27 RRMS patients', 'Eleven patients in the bosentan arm and thirteen patients in the', 'patients with MS', 'patients with relapsing remitting MS (RRMS']","['Magnetic resonance imaging (MRI', 'CBF', 'placebo']","['CBF', 'NAA/creatine (NAA/Cr) ratio in NAWM of the centrum semiovale', 'NAA levels and clinical symptoms']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4028269', 'cui_str': 'Nuclear magnetic resonance imaging brain'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522002', 'cui_str': 'RRM Motif'}, {'cui': 'C0252643', 'cui_str': 'bosentan'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0067684', 'cui_str': 'N-acetyl-L-aspartate'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0228181', 'cui_str': 'Structure of centrum semiovale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",27.0,0.156998,There were no effects on NAA levels and clinical symptoms.  ,"[{'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Hostenbach', 'Affiliation': 'Department of Neurology, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Raeymaekers', 'Affiliation': 'Department of Radiology and Medical Physics, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Van Schuerbeek', 'Affiliation': 'Department of Radiology and Medical Physics, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Vanbinst', 'Affiliation': 'Department of Radiology and Medical Physics, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Cools', 'Affiliation': 'Interfaculty Center Data Processing and Statistics, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'De Keyser', 'Affiliation': 'Department of Neurology, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': ""D'Haeseleer"", 'Affiliation': 'Department of Neurology, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}]",Frontiers in neurology,['10.3389/fneur.2020.00674']
1877,32779460,[Practical application of ophthalmic nutraceuticals in patients with dry form of age-related macular degeneration].,"Development and progression of age-related macular degeneration (AMD) is associated with insufficiency of protective antioxidant systems of the body. Nutraceutical medications can positively affect the course of the disease and the visual functions of patients with AMD.
PURPOSE


To conduct a placebo-controlled clinical monitoring of visual functions in patients with dry AMD while taking a drug Complex that corresponds to the AREDS 2 formula.
MATERIAL AND METHODS


The study included 90 people in 3 equivalent parallel groups, two of which were represented by patients with AMD who took the Complex for 3-6 months or Placebo for 3 months. The third group included healthy subjects of the same age. In addition to standard eye examination, participants underwent evaluation of the macular pigment optical density (MPOD), spatial-frequency contrast sensitivity (CS), photostress test, and reading parameters on the Salzburg Reading Desk device. The changes of blood plasma antioxidant activity (AOA) were also evaluated in the main group.
RESULTS


By day 90 of the study, patients of the main group showed statistically significant ( p <0.001) growth of MPOD from 0.24±0.13 to 0.32±0.1, reduction of photostress recovery time from 68.2±17.8 to 57.3±17.5 seconds, improvement of high-spatial-frequency CS - from 25.0±8.2 to 30.6±6.8 dB, increase of near visual acuity logMAR from 0.22±0.04 to 0.19±0.03 and reading speed, and decrease of reading mistakes. Statistically significant ( p <0.05) reduction of in AOA was seen during the observation period from 1.52±0.16 to 1.68±0.16. Patients of the main group who received the Complex for 180 days demonstrated additional improvements of visual functions.
CONCLUSION


The drug Complex corresponding to the AREDS 2 formula contributes to a significant increase in MPOD, improvements of visual functions and overall antioxidant status of patients, which confirms the feasibility of its use in patients with dry AMD.",2020,"By day 90 of the study, patients of the main group showed statistically significant ( p <0.001) growth of MPOD from 0.24±0.13 to 0.32±0.1, reduction of photostress recovery time from 68.2±17.8 to 57.3±17.5 seconds, improvement of high-spatial-frequency CS - from 25.0±8.2 to 30.6±6.8 dB, increase of near visual acuity logMAR from 0.22±0.04 to 0.19±0.03 and reading speed, and decrease of reading mistakes.","['patients with AMD', 'patients with dry AMD', 'healthy subjects of the same age', 'patients with dry form of age-related macular degeneration', '90 people in 3 equivalent parallel groups, two of which were represented by patients with AMD who took the Complex for 3-6 months or Placebo for 3 months']",['placebo'],"['photostress recovery time', 'AOA', 'near visual acuity logMAR', 'blood plasma antioxidant activity (AOA', 'MPOD', 'reading mistakes', 'visual functions and overall antioxidant status', 'visual functions', 'macular pigment optical density (MPOD), spatial-frequency contrast sensitivity (CS), photostress test, and reading parameters on the Salzburg Reading Desk device', 'growth of MPOD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C3888461', 'cui_str': 'Dry age-related macular degeneration'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0429489', 'cui_str': 'Photostress recovery time'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C3850163', 'cui_str': 'Macular Pigment'}, {'cui': 'C0439164', 'cui_str': 'OD units'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0430873', 'cui_str': 'Photostress test'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",90.0,0.0372968,"By day 90 of the study, patients of the main group showed statistically significant ( p <0.001) growth of MPOD from 0.24±0.13 to 0.32±0.1, reduction of photostress recovery time from 68.2±17.8 to 57.3±17.5 seconds, improvement of high-spatial-frequency CS - from 25.0±8.2 to 30.6±6.8 dB, increase of near visual acuity logMAR from 0.22±0.04 to 0.19±0.03 and reading speed, and decrease of reading mistakes.","[{'ForeName': 'E N', 'Initials': 'EN', 'LastName': 'Eskina', 'Affiliation': 'Academy of post-graduate education of the Federal Clinical Scientific Center of the Federal Medical-Biological Agency, Moscow, Russia.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Belogurova', 'Affiliation': 'Ophthalmological clinic «Sphera» of Professor Eskina, Moscow, Russia.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Gvetadze', 'Affiliation': 'Ophthalmological clinic «Sphera» of Professor Eskina, Moscow, Russia.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Smorchkova', 'Affiliation': 'Ophthalmological clinic «Sphera» of Professor Eskina, Moscow, Russia.'}]",Vestnik oftalmologii,['10.17116/oftalma202013604186']
1878,32779497,"Pooled Analysis of Bleeding, Major Adverse Cardiovascular Events, and All-Cause Mortality in Clinical Trials of Time-Constrained Dual-Antiplatelet Therapy After Percutaneous Coronary Intervention.","Background The net clinical benefit of dual antiplatelet therapy (DAPT) reflects the paradoxical effects of an increased risk of bleeding and a reduced risk of major adverse cardiovascular events. A time-constrained approach to DAPT has been recently investigated in 5 multicenter trials including GLOBAL LEADERS, STOPDAPT2 (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2), SMART-CHOICE, TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention), and TICO (Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus Stent for Acute Coronary Syndrome). Methods and Results We undertook a pooled analysis of these trials to assess the overall associations between time-constrained P2Y12 inhibitor monotherapy (aspirin-free regimen) for bleeding events, major adverse cardiovascular events, and all-cause mortality as compared to standard care with DAPT for at least 12 months post-percutaneous coronary intervention. We implemented a DerSimonian and Laird random effects meta-analysis using the metafor package in R. 32 361 randomized trial participants, including 16 898 (52.2%) who had a history of acute coronary syndrome, underwent percutaneous coronary intervention, and had outcome data available. P2Y12 inhibitor monotherapy from 1 to 3 months was associated with a reduced risk for bleeding (hazard ratio [HR] 0.60; 95% CI, 0.45-0.81), including in the acute coronary syndrome group in which the magnitude of risk reduction was greatest (HR 0.50; 95% CI, 0.41-0.61). The estimates of the effect of P2Y12 inhibitor monotherapy on the HR were also favorable for major adverse cardiovascular events (0.88; 95% CI, 0.77-1.02) and all-cause mortality (0.85; 95% CI, 0.71-1.03). Conclusions Compared with DAPT for 12 months post-percutaneous coronary intervention, P2Y12 inhibitor monotherapy from 1 to 3 months substantially reduces the risk of major and fatal bleeding and, in addition, confers potentially protective effects, for major adverse cardiovascular events and all-cause mortality. Considering patient safety, the results support a strategy of DAPT for 1 to 3 months followed by aspirin-free P2Y12 inhibitor monotherapy.",2020,"P2Y12 inhibitor monotherapy from 1 to 3 months was associated with a reduced risk for bleeding (hazard ratio [HR] 0.60; 95% CI, 0.45-0.81), including in the acute coronary syndrome group in which the magnitude of risk reduction was greatest (HR 0.50; 95% CI, 0.41-0.61).","['High-Risk Patients', 'R. 32\u2009361 randomized trial participants, including 16\xa0898 (52.2%) who had a history of acute coronary syndrome, underwent percutaneous coronary intervention, and had outcome data available', 'for Acute Coronary Syndrome']","['aspirin-free P2Y12 inhibitor monotherapy', 'STOPDAPT2', 'DAPT', 'Dual Antiplatelet Therapy', 'New Generation Sirolimus Stent', 'P2Y12 inhibitor monotherapy', 'Everolimus-Eluting Cobalt-Chromium Stent-2), SMART-CHOICE, TWILIGHT', 'Ticagrelor With Aspirin', 'dual antiplatelet therapy (DAPT', 'TICO (Ticagrelor Monotherapy', 'P2Y12 inhibitor monotherapy (aspirin-free regimen']","['Bleeding, Major Adverse Cardiovascular Events, and All-Cause Mortality', 'risk reduction', 'reduced risk for bleeding', 'major adverse cardiovascular events', 'bleeding events, major adverse cardiovascular events', 'risk of major and fatal bleeding']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517801', 'cui_str': '52.2'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}]",,0.0468397,"P2Y12 inhibitor monotherapy from 1 to 3 months was associated with a reduced risk for bleeding (hazard ratio [HR] 0.60; 95% CI, 0.45-0.81), including in the acute coronary syndrome group in which the magnitude of risk reduction was greatest (HR 0.50; 95% CI, 0.41-0.61).","[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'McClure', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre Institute of Cardiovascular and Medical Sciences University of Glasgow United Kingdom.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Ramsay', 'Affiliation': 'West of Scotland Heart and Lung Centre Golden Jubilee National Hospital Clydebank United Kingdom.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre Institute of Cardiovascular and Medical Sciences University of Glasgow United Kingdom.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.017109']
1879,32779505,"Effects of Epeleuton, a Novel Synthetic Second-Generation n-3 Fatty Acid, on Non-Alcoholic Fatty Liver Disease, Triglycerides, Glycemic Control, and Cardiometabolic and Inflammatory Markers.","Background Epeleuton is 15-hydroxy eicosapentaenoic acid ethyl ester, a second-generation synthetic n-3 fatty acid derivative of eicosapentaenoic acid. The primary objective was to assess the effect of epeleuton on markers of nonalcoholic fatty liver disease (NAFLD) with post hoc analyses of cardiometabolic markers. Methods and Results In a multicenter, randomized, double-blind, placebo-controlled trial, 96 adults with nonalcoholic fatty liver disease and body mass index 25 to 40 were randomized in a 1:1:1 ratio to receive epeleuton 2 g/day, epeleuton 1 g/day, or placebo for 16 weeks. A total of 27% of patients had diabetes mellitus. Primary end points of changes in alanine aminotransferase and liver stiffness did not improve at week 16. Secondary and post hoc analyses investigated changes in cardiometabolic markers. Epeleuton 2 g/day significantly decreased triglycerides, very-low-density lipoprotein cholesterol, and total cholesterol without increasing low-density lipoprotein cholesterol. Despite a low mean baseline hemoglobin A1C (HbA 1C ; 6.3±1.3%), epeleuton 2 g/day significantly decreased HbA 1c  (-0.4%;  P =0.026). Among patients with baseline HbA 1c  >6.5%, epeleuton 2 g/day decreased HbA 1c  by 1.1% ( P =0.047; n=26). Consistent dose-dependent reductions were observed for fasting plasma glucose, insulin, and insulin resistance indices. Epeleuton 2 g/day decreased circulating markers of cardiovascular risk and endothelial dysfunction. Epeleuton was well tolerated, with a safety profile not different from placebo. Conclusions While epeleuton did not meet its primary end points on alanine aminotransferase or liver stiffness, it significantly decreased triglycerides, HbA 1C , plasma glucose, and inflammatory markers. These data suggest epeleuton may have potential for cardiovascular risk reduction and nonalcoholic fatty liver disease by simultaneously targeting hypertriglyceridemia, hyperglycemia, and systemic inflammation. Further trials are planned. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT02941549.",2020,"Epeleuton 2 g/day significantly decreased triglycerides, very-low-density lipoprotein cholesterol, and total cholesterol without increasing low-density lipoprotein cholesterol.",['96 adults with nonalcoholic fatty liver disease and body mass index 25 to 40'],"['Registration URL', 'Epeleuton, a Novel Synthetic Second-Generation n-3 Fatty Acid', 'epeleuton 2\xa0g/day, epeleuton 1\xa0g/day, or placebo', 'placebo']","['cardiometabolic markers', 'circulating markers of cardiovascular risk and endothelial dysfunction', 'triglycerides, very-low-density lipoprotein cholesterol, and total cholesterol without increasing low-density lipoprotein cholesterol', 'nonalcoholic fatty liver disease (NAFLD', 'Non-Alcoholic Fatty Liver Disease, Triglycerides, Glycemic Control, and Cardiometabolic and Inflammatory Markers', 'fasting plasma glucose, insulin, and insulin resistance indices', 'diabetes mellitus', 'triglycerides, HbA 1C , plasma glucose, and inflammatory markers', 'alanine aminotransferase and liver stiffness', 'alanine aminotransferase or liver stiffness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023826', 'cui_str': 'VLDL cholesterol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}]",96.0,0.456088,"Epeleuton 2 g/day significantly decreased triglycerides, very-low-density lipoprotein cholesterol, and total cholesterol without increasing low-density lipoprotein cholesterol.","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Climax', 'Affiliation': 'Afimmune Dublin Ireland.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Newsome', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre at University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham United Kingdom.'}, {'ForeName': 'Moayed', 'Initials': 'M', 'LastName': 'Hamza', 'Affiliation': 'Afimmune Dublin Ireland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Weissbach', 'Affiliation': 'Afimmune Dublin Ireland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Coughlan', 'Affiliation': 'Afimmune Dublin Ireland.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences University of Glasgow United Kingdom.'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'University of Texas Southwestern Medical Center Dallas TX.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center Harvard Medical School Boston MA.""}]",Journal of the American Heart Association,['10.1161/JAHA.119.016334']
1880,32779534,Acute effects of body-weight resistance exercises on blood pressure and glycemia in middle-aged adults with hypertension.,"OBJECTIVE


The purpose of the present study was to evaluate the acute effects of single session of body-weight resistance exercises on blood pressure (BP) and glycemia in middle-aged adults with hypertension.
METHODS


Twenty-three participants took part in this trial with crossover design and performed two experimental sessions in a random order: Body-weight resistance exercise session (BWR) and a control session without exercise. BWR was composed of four exercises: inverted row, squat, , and sit-ups. The participants performed 3 sets of 30 s, in which they were instructed to perform as much repetitions as possible and as fast as possible. After each session, BP and glycemia were measured continuously for 60 min.
RESULTS


Systolic BP decreased after BWR when compared with control at post 45': -7 (95%CI:-11 to -2) mmHg,  p  = .003 and post60': -7 (95%CI:-12 to -3) mmHg,  p  = .003. Diastolic BP decreased after BWR when compared with control at post 15': -6 (95%CI:-9 to -3) mmHg,  p  < .001; post 30': -6 (95%CI:-9 to -2) mmHg,  p  = .001; post45': -5 (95%CI:-9 to -2) mmHg,  p  = .005; and post60': -6 (95%CI: -8 to -3) mmHg,  p  < .001. No significant difference was found in glycemia between BWR and control sessions.
CONCLUSION


BWR acutely reduces BP in middle-aged adults with hypertension without effects on usual glycemia responses. This alternative form of resistance training could facilitate access, adherence, and reduce health costs related to exercise programs.",2020,Diastolic BP decreased after BWR when compared with control at post 15': -6,"['middle-aged adults with hypertension', 'Twenty-three participants took part in this trial with crossover design and performed two experimental sessions in a random order']","['Body-weight resistance exercise session (BWR) and a control session without exercise', 'body-weight resistance exercises']","['glycemia', 'Systolic BP', 'blood pressure (BP) and glycemia', 'Diastolic BP', 'BP and glycemia', 'blood pressure and glycemia', 'BP']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",23.0,0.0731685,Diastolic BP decreased after BWR when compared with control at post 15': -6,"[{'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ferrari', 'Affiliation': 'Universidade Federal Do Rio Grande Do Sul , Porto Alegre, Brazil.'}, {'ForeName': 'Eduardo Lusa', 'Initials': 'EL', 'LastName': 'Cadore', 'Affiliation': 'Universidade Federal Do Rio Grande Do Sul , Porto Alegre, Brazil.'}, {'ForeName': 'Bibiana', 'Initials': 'B', 'LastName': 'Périco', 'Affiliation': 'Faculdade Sogipa de Educação Física , Porto Alegre, Brazil.'}, {'ForeName': 'Gabriela Bartholomay', 'Initials': 'GB', 'LastName': 'Kothe', 'Affiliation': 'Faculdade Sogipa de Educação Física , Porto Alegre, Brazil.'}]","Clinical and experimental hypertension (New York, N.Y. : 1993)",['10.1080/10641963.2020.1806293']
1881,32779610,Influence of Self-Expanding Paclitaxel-Eluting Stent Sizing on Neointimal Hyperplasia in Superficial Femoral Artery Lesions.,"BACKGROUND


Although self-expanding drug-eluting stents (DES) have recently shown superior outcomes for superficial femoral artery (SFA) lesions, optimal sizing of DES diameter in SFA intervention is unclear.Methods and Results:A total of 40 de novo SFA lesions were randomized 1:1 to receive self-expanding DES with either a 1-mm or 2-mm larger diameter than the reference vessel diameter. Follow-up optical coherence tomography (OCT) was scheduled 6 months after DES implantation to evaluate the vascular response to the stents. Volume index (VI) was defined as volume divided by stent length. The primary endpoint was neointimal VI at 6 months. Baseline reference vessel diameter was similar between the 1-mm larger diameter group and the 2-mm larger diameter group (5.0±0.8 mm vs. 4.7±0.9 mm, P=0.35). Stent diameter was 6.3±0.6 mm in the 1-mm larger group and 7.1±0.6 mm in the 2-mm larger group (P<0.0001), and stent to reference vessel diameter ratio (SV ratio) was 1.3±0.2 and 1.5±0.2 (P<0.0001), respectively. At 6-month, neointimal VI was greater in the 2-mm larger diameter group (5.5±1.5 mm 2 vs. 9.6±3.4 mm 2 , P<0.001). The correlation analysis revealed that degree of neointimal VI was positively correlated with SV ratio (r=0.43, P<0.01).
CONCLUSIONS


Implantation of self-expanding DES with a considerably high SV ratio resulted in neointimal hyperplasia in SFA lesions.",2020,"At 6-month, neointimal VI was greater in the 2-mm larger diameter group (5.5±1.5 mm 2 vs. 9.6±3.4 mm 2 , P<0.001).","['A total of 40 de novo SFA lesions', 'Superficial Femoral Artery Lesions']","['self-expanding drug-eluting stents (DES', 'Self-Expanding Paclitaxel-Eluting Stent Sizing', 'self-expanding DES', 'Follow-up optical coherence tomography (OCT']","['degree of neointimal VI', 'Baseline reference vessel diameter', 'Volume index (VI', 'stent to reference vessel diameter ratio (SV ratio', 'Stent diameter', 'neointimal VI']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0447106', 'cui_str': 'Superficial femoral artery'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",40.0,0.121706,"At 6-month, neointimal VI was greater in the 2-mm larger diameter group (5.5±1.5 mm 2 vs. 9.6±3.4 mm 2 , P<0.001).","[{'ForeName': 'Kojiro', 'Initials': 'K', 'LastName': 'Miki', 'Affiliation': 'Department of Cardiovascular and Renal Medicine, Hyogo College of Medicine.'}, {'ForeName': 'Takamasa', 'Initials': 'T', 'LastName': 'Tanaka', 'Affiliation': 'Department of Cardiovascular and Renal Medicine, Hyogo College of Medicine.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Yanaka', 'Affiliation': 'Department of Cardiovascular and Renal Medicine, Hyogo College of Medicine.'}, {'ForeName': 'Nagataka', 'Initials': 'N', 'LastName': 'Yoshihara', 'Affiliation': 'Department of Cardiovascular and Renal Medicine, Hyogo College of Medicine.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Department of Cardiovascular and Renal Medicine, Hyogo College of Medicine.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Imanaka', 'Affiliation': 'Department of Cardiovascular and Renal Medicine, Hyogo College of Medicine.'}, {'ForeName': 'Hirokuni', 'Initials': 'H', 'LastName': 'Akahori', 'Affiliation': 'Department of Cardiovascular and Renal Medicine, Hyogo College of Medicine.'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Ishihara', 'Affiliation': 'Department of Cardiovascular and Renal Medicine, Hyogo College of Medicine.'}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-20-0470']
1882,32779626,Corrigendum*: Effects of Computer-based Stress Management Training on Psychological Well-being and Work Performance in Japanese Employees: A Cluster Randomized Controlled Trial.,"In Table 2, Mean and SD were opposite between the intervention group and the wait-list control group. In Table 3, there was a mistake in the annotation: the number of the intervention group was 142. The corrected Table 2 and Table 3 are presented below. We apologize for any inconvenience that this may have caused. *Important errors made by the author(s).",2020,"In Table 2, Mean and SD were opposite between the intervention group and the wait-list control group.",['Japanese Employees'],['Computer-based Stress Management Training'],['Psychological Well-being and Work Performance'],"[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0599987', 'cui_str': 'Employee'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C1286385', 'cui_str': 'Performance at work'}]",,0.0325394,"In Table 2, Mean and SD were opposite between the intervention group and the wait-list control group.","[{'ForeName': 'Rino', 'Initials': 'R', 'LastName': 'Umanodan', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Japan.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Shimazu', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Japan.'}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Minami', 'Affiliation': 'Department of Public Health / Health Policy, The University of Tokyo, Japan.'}, {'ForeName': 'Norito', 'Initials': 'N', 'LastName': 'Kawakam', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Japan.'}]",Industrial health,['10.2486/indhealth.2013-0209c1']
1883,32779643,Reduction of postural nasal resistance following oropharyngeal surgery in patients with moderate-severe obstructive sleep apnea.,"BACKGROUND


Patients with obstructive sleep apnea (OSA) have elevated nasopharyngeal resistances due to increased turbulent airflow. The study aims to investigate the effect of oropharyngeal surgery on nasal resistance in patients with various severity levels of OSA.
METHODOLOGY


Patients with greater or equal to 5 events hourly on the apnea-hypopnea index (AHI) were enrolled. Patients with retropalatal obstruction underwent uvulopalatopharyngoplasty, while patients with concurrent retrolingual obstruction under- went uvulopalatopharyngoplasty (UPPP) plus tongue base suspension. Before surgery and after surgery, subjective outcomes were assessed using a visual analog scale (VAS), and objective outcomes were assessed using overnight polysomnography and rhinomanometry. The limitation of the study was that UPPP instead of expansion sphincter pharyngoplasty was performed in this study.
RESULTS


Sixty-two patients were enrolled, while 30 patients were diagnosed as mild OSA (group Mild) and 32 patients were mo- derate-severe OSA (group MS). The preoperative VAS of nasal obstruction in recumbency during sleep was significantly reduced after surgery in group MS. However, no significant differences between preoperative and postoperative VAS were found in group Mild. The postoperative anterior and posterior total nasal resistances (TNR) in sitting and supine positions were not significantly different from those before surgery in group. In contrast, the postoperative posterior TNR in supine position was 0.292±0.301(Pa/ cm3/s), compared with 0.425±0.343(Pa/cm3/s) preoperatively.
CONCLUSIONS


Oropharyngeal surgery improves nasal obstruction during sleep and lowers the supine TNR measured in poste- rior rhinomanometry in patients with moderate-severe OSA. Oropharyngeal surgery is a possible treatment for postural nasal obstruction in patients with moderate-severe OSA.",2020,The postoperative anterior and posterior total nasal resistances (TNR) in sitting and supine positions were not significantly different from those before surgery in group.,"['Patients with obstructive sleep apnea (OSA', 'Patients with retropalatal obstruction underwent uvulopalatopharyngoplasty, while patients with concurrent retrolingual obstruction under- went', 'patients with moderate-severe obstructive sleep apnea', 'Sixty-two patients were enrolled, while 30 patients were diagnosed as mild OSA (group Mild) and 32 patients were mo- derate-severe OSA (group MS', 'patients with various severity levels of OSA.\nMETHODOLOGY\n\n\nPatients with greater or equal to 5 events hourly on the apnea-hypopnea index (AHI) were enrolled', 'patients with moderate-severe OSA']","['Oropharyngeal surgery', 'oropharyngeal surgery', 'uvulopalatopharyngoplasty (UPPP) plus tongue base suspension']","['postural nasal resistance', 'nasal resistance', 'preoperative VAS of nasal obstruction in recumbency during sleep', 'preoperative and postoperative VAS', 'postoperative anterior and posterior total nasal resistances (TNR) in sitting and supine positions', 'nasal obstruction', 'visual analog scale (VAS), and objective outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C1535578', 'cui_str': 'Palatopharyngoplasty'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}]","[{'cui': 'C0597139', 'cui_str': 'Oropharyngeal surgery'}, {'cui': 'C1535578', 'cui_str': 'Palatopharyngoplasty'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0226958', 'cui_str': 'Structure of root of tongue'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]","[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0429208', 'cui_str': 'Nasal resistance'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C0587116', 'cui_str': 'During sleep'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",62.0,0.0208761,The postoperative anterior and posterior total nasal resistances (TNR) in sitting and supine positions were not significantly different from those before surgery in group.,"[{'ForeName': 'C-C', 'Initials': 'CC', 'LastName': 'Huang', 'Affiliation': 'Department of Otolaryngology, Far Eastern Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'P-W', 'Initials': 'PW', 'LastName': 'Cheng', 'Affiliation': 'Department of Otolaryngology, Far Eastern Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'L-J', 'Initials': 'LJ', 'LastName': 'Liao', 'Affiliation': 'Department of Otolaryngology, Far Eastern Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'T-W', 'Initials': 'TW', 'LastName': 'Huang', 'Affiliation': 'Department of Otolaryngology, Far Eastern Memorial Hospital, Taipei, Taiwan.'}]",Rhinology,['10.4193/Rhin19.331']
1884,32779711,The Impact of Moderate or High-Intensity Combined Exercise on Systemic Inflammation among Older Persons with and without HIV.,"BACKGROUND


We investigated whether higher intensity exercise provided greater overall decrease in key markers of inflammation, and whether responses to exercise intensity differed by HIV serostatus.
METHODS


People with HIV (PWH; n=32) and controls (n=37) aged 50-75 completed 12 weeks of moderate-intensity combined exercise then were randomized to moderate- or high-intensity exercise for 12 additional weeks (n=27 and 29, respectively). Inflammation biomarkers were measured at 0, 12, 24 weeks. Mixed and multiple regression models were adjusted for baseline inflammation, age and BMI.
RESULTS


Baseline TNF-α, sTNFR2, and sCD14 were significantly higher among PWH than controls (p<0.04). From week 0-12, changes in IL-6, TNF-α, sTNFR1 were not significantly different by HIV serostatus. We found no significant interaction between HIV serostatus/exercise intensity on week 12-24 changes in IL-6, TNF-α, sTNFR1. Among high-intensity exercisers, both PWH and controls had significant increases in sCD14 (p≤0.003), controls had significant increases in IL-10 (p=0.01), PWH had a non-significant decrease in hsCRP (p=0.07). Other markers were not significantly different by serostatus and exercise intensity.
DISCUSSION


Moderate and high-intensity exercise elicited similar effects on inflammation among PWH and controls, with additional beneficial effects seen only among the high-intensity exercisers. Increase in sCD14 and attenuated IL-10 increase (PWH only) merit further study.",2020,"We found no significant interaction between HIV serostatus/exercise intensity on week 12-24 changes in IL-6, TNF-α, sTNFR1.","['People with HIV (PWH; n=32) and controls (n=37) aged 50-75 completed 12 weeks of', 'Older Persons with and without HIV']","['moderate- or high-intensity exercise', 'Moderate or High-Intensity Combined Exercise', 'moderate-intensity combined exercise']","['hsCRP', 'Inflammation biomarkers', 'sCD14', 'Baseline TNF-α, sTNFR2, and sCD14', 'Systemic Inflammation', 'IL-6, TNF-α, sTNFR1', 'IL-10']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",,0.129495,"We found no significant interaction between HIV serostatus/exercise intensity on week 12-24 changes in IL-6, TNF-α, sTNFR1.","[{'ForeName': 'Kristine M', 'Initials': 'KM', 'LastName': 'Erlandson', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Department of Medicine, Division of Infectious Diseases; Aurora, CO.'}, {'ForeName': 'Melissa P', 'Initials': 'MP', 'LastName': 'Wilson', 'Affiliation': 'University of Colorado Anschutz Medical Campus, School of Public Health; Aurora, CO.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'MaWhinney', 'Affiliation': 'University of Colorado Anschutz Medical Campus, School of Public Health; Aurora, CO.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rapaport', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Department of Medicine, Division of Infectious Diseases; Aurora, CO.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Department of Medicine, Division of Infectious Diseases; Aurora, CO.'}, {'ForeName': 'Cara C', 'Initials': 'CC', 'LastName': 'Wilson', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Department of Medicine, Division of Infectious Diseases; Aurora, CO.'}, {'ForeName': 'Jeremy T', 'Initials': 'JT', 'LastName': 'Rahkola', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Department of Medicine, Division of Infectious Diseases; Aurora, CO.'}, {'ForeName': 'Edward N', 'Initials': 'EN', 'LastName': 'Janoff', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Department of Medicine, Division of Infectious Diseases; Aurora, CO.'}, {'ForeName': 'Todd T', 'Initials': 'TT', 'LastName': 'Brown', 'Affiliation': 'Johns Hopkins University, Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism, Baltimore, MD.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Campbell', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Department of Medicine, Division of Infectious Diseases; Aurora, CO.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Jankowski', 'Affiliation': 'University of Colorado Anschutz Medical Campus, College of Nursing; Aurora, CO.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa494']
1885,32779728,Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia (COVID STEROID) trial-Protocol and statistical analysis plan.,"INTRODUCTION


Severe acute respiratory syndrome coronavirus-2 has caused a pandemic of coronavirus disease (COVID-19) with many patients developing hypoxic respiratory failure. Corticosteroids reduce the time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality in similar patient populations. However, corticosteroids have undesirable effects, including longer time to viral clearance. Clinical equipoise on the use of corticosteroids for COVID-19 exists.
METHODS


The COVID STEROID trial is an international, randomised, stratified, blinded clinical trial. We will allocate 1000 adult patients with COVID-19 receiving ≥10 L/min of oxygen or on mechanical ventilation to intravenous hydrocortisone 200 mg daily vs placebo (0.9% saline) for 7 days. The primary outcome is days alive without life support (ie mechanical ventilation, circulatory support, and renal replacement therapy) at day 28. Secondary outcomes are serious adverse reactions at day 14; days alive without life support at day 90; days alive and out of hospital at day 90; all-cause mortality at day 28, day 90, and 1 year; and health-related quality of life at 1 year. We will conduct the statistical analyses according to this protocol, including interim analyses for every 250 patients followed for 28 days. The primary outcome will be compared using the Kryger Jensen and Lange test in the intention to treat population and reported as differences in means and medians with 95% confidence intervals.
DISCUSSION


The COVID STEROID trial will provide important evidence to guide the use of corticosteroids in COVID-19 and severe hypoxia.",2020,"Corticosteroids reduce the time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality in similar patient populations.","['patients with COVID-19 and severe hypoxia', '1000 adult patients with COVID-19 receiving ≥10\xa0L/min of oxygen or on']","['Low-dose hydrocortisone', 'mechanical ventilation to intravenous hydrocortisone 200\xa0mg daily vs placebo (0.9% saline', 'Corticosteroids']","['longer time to viral clearance', 'Kryger Jensen and Lange test in the intention to treat population', 'health-related quality of life', 'days alive without life support (ie mechanical ventilation, circulatory support, and renal replacement therapy', 'time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality', 'serious adverse reactions at day 14; days alive without life support at day 90; days alive and out of hospital at day 90; all-cause mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C3665438', 'cui_str': 'Juxtapapillary focal retinitis AND retinochoroiditis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",1000.0,0.37202,"Corticosteroids reduce the time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality in similar patient populations.","[{'ForeName': 'Marie Warrer', 'Initials': 'MW', 'LastName': 'Petersen', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Tine Sylvest', 'Initials': 'TS', 'LastName': 'Meyhoff', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Helleberg', 'Affiliation': 'Department of Infectious Diseases, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Maj-Brit Nørregaard', 'Initials': 'MN', 'LastName': 'Kjær', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Granholm', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Carl Johan Steensen', 'Initials': 'CJS', 'LastName': 'Hjortsø', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Thomas Steen', 'Initials': 'TS', 'LastName': 'Jensen', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Morten Hylander', 'Initials': 'MH', 'LastName': 'Møller', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Peter Buhl', 'Initials': 'PB', 'LastName': 'Hjortrup', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mik', 'Initials': 'M', 'LastName': 'Wetterslev', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Gitte Kingo', 'Initials': 'GK', 'LastName': 'Vesterlund', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Russell', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Vibeke Lind', 'Initials': 'VL', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Thoracic Anaesthesiology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Tjelle', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'Department of Infectious Diseases, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Charlotte Suppli', 'Initials': 'CS', 'LastName': 'Ulrik', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne Sofie', 'Initials': 'AS', 'LastName': 'Andreasen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mohr', 'Affiliation': 'Department of Intensive Care, Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Bestle', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Nordsjællands Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lone Musaeus', 'Initials': 'LM', 'LastName': 'Poulsen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Zealand University Hospital, Køge, Denmark.'}, {'ForeName': 'Mette Friberg', 'Initials': 'MF', 'LastName': 'Hitz', 'Affiliation': 'Internal Medicine Department, Endocrinology, Zealand University Hospital, Køge, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hildebrandt', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Lene Surland', 'Initials': 'LS', 'LastName': 'Knudsen', 'Affiliation': 'Department of Infectious Diseases, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Møller', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Næstved-Slagelse-Ringsted Hospital, Slagelse, Denmark.'}, {'ForeName': 'Christoffer Grant', 'Initials': 'CG', 'LastName': 'Sølling', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Viborg Hospital, Viborg, Denmark.'}, {'ForeName': 'Anne Craveiro', 'Initials': 'AC', 'LastName': 'Brøchner', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Kolding Hospital, Kolding, Denmark.'}, {'ForeName': 'Bodil Steen', 'Initials': 'BS', 'LastName': 'Rasmussen', 'Affiliation': 'Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Nielsen', 'Affiliation': 'Department of Infectious Diseases, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Christensen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Strøm', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cronhjort', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Rebecka Rubenson', 'Initials': 'RR', 'LastName': 'Wahlin', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Jakob', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cioccari', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Balasubramanian', 'Initials': 'B', 'LastName': 'Venkatesh', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Hammond', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Vivekanand', 'Initials': 'V', 'LastName': 'Jha', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, New Delhi, India.'}, {'ForeName': 'Sheila Nainan', 'Initials': 'SN', 'LastName': 'Myatra', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13673']
1886,32779919,[Is osteoarthritis an inflammatory disease after all?; prednisolone effective in osteoarthritis of the hand].,"There are very few treatment options that modify the course of osteoarthritis (OA) of the hand; the only current treatment options are physiotherapy and analgesics. At the moment, OA is regarded as a disease of the entire joint, with involvement of cartilage, bone, synovium, ligaments and muscles and new treatment options can focus on these structures. In a double-blind, placebo-controlled trial, treatment of patients with inflammatory OA of the hand (with pain, soft-tissue swelling and an ultrasound picture characteristic of inflammation) with 10 mg prednisolone per day for 6 weeks resulted in a larger decrease in pain than placebo did. This short-term study does certainly not provide the definitive answer for treating this chronic disease, and long-term use of prednisolone is associated with several side-effects. Nevertheless, this breakthrough study clearly demonstrates that the use of anti-inflammatory, anti-rheumatic medication may have a favourable effect on inflammatory OA of the hand. Studies of anti-inflammatory drugs with a better long-term safety profile will be welcome.",2020,There are very few treatment options that modify the course of osteoarthritis (OA) of the hand; the only current treatment options are physiotherapy and analgesics.,"['patients with inflammatory OA of the hand (with pain, soft-tissue swelling and an ultrasound picture characteristic of inflammation']","['prednisolone', 'placebo']",['pain'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0263746', 'cui_str': 'Degenerative joint disease of hand'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037580', 'cui_str': 'Soft tissue swelling'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0822556,There are very few treatment options that modify the course of osteoarthritis (OA) of the hand; the only current treatment options are physiotherapy and analgesics.,"[{'ForeName': 'Willem F', 'Initials': 'WF', 'LastName': 'Lems', 'Affiliation': 'Amsterdam UMC, locatie VUmc, afd. Reumatologie, Amsterdam.'}]",Nederlands tijdschrift voor geneeskunde,[]
1887,32779931,[A requiem for prehydration in CT imaging?],"A recently published randomised controlled trial (the Kompas trial) compared prehydration with sodium bicarbonate solution with no prehydration in patients with chronic kidney disease (eGFR 30-60 ml/min per 1.73 m2) undergoing elective CT scanning with intravenous contrast agent. Although patients were considered to be at risk for postcontrast acute kidney injury (PC-AKI), average serum creatinine concentration increased by 2% after 5-7 days with no serious persistent decline in renal function. No significant differences were found between treatment and no treatment arms of the study. Results are in agreement with previous trials and confirm that risk of clinically relevant PC-AKI is very low and that prehydration is not warranted in this group of patients. Patients with an eGFR of less than 30 ml/min per 1.73 m2 and multiple AKI risk factors have a higher risk of PCI-AKI and may benefit from prehydration, although the risk-benefit balance remains unclear.",2020,No significant differences were found between treatment and no treatment arms of the study.,['patients with chronic kidney disease (eGFR 30-60 ml/min per 1.73 m2) undergoing'],"['prehydration with sodium bicarbonate solution with no prehydration', 'elective CT scanning with intravenous contrast agent']","['renal function', 'serum creatinine concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}]","[{'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0756507,No significant differences were found between treatment and no treatment arms of the study.,"[{'ForeName': 'M G H', 'Initials': 'MGH', 'LastName': 'Betjes', 'Affiliation': 'Erasmus MC, afd. Interne Geneeskunde, Rotterdam.'}]",Nederlands tijdschrift voor geneeskunde,[]
1888,32779952,Comparison of CD4 Counts with Mycophenolate Mofetil versus Methotrexate from the First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial.,"PURPOSE


Sub-analysis of the FAST Trial comparing change in CD4 (∆CD4) from baseline through 12 months in uveitis patients treated with mycophenolate mofetil (MMF) and methotrexate (MTX).
METHODS


Patients were randomly allocated to 1.5 g twice daily MMF or 25 mg weekly MTX. Individuals with CD4 counts at baseline, 6 months (or treatment failure prior), and 12 months (or treatment failure between 6 and 12 months) were included. The association between treatment and ∆CD4 (cells/μL) was analyzed using multivariable linear regression.
RESULTS


There was no significant difference in ∆CD4 between MMF and MTX at 6 months (-31.7 cells/μL for MMF compared to MTX; 95% CI: -358.2 to 294.8,  P  = .85) and 12 months (-78.3 cells/μL for MMF compared to MTX; 95% CI: -468.0 to 311.3;  P  = .69).
CONCLUSION


There was no significant difference in ∆CD4 between MMF and MTX from baseline to 12 months, suggesting that MMF does not confer additional risk of CD4 lymphopenia in uveitic patients. ClinicalTrials.gov Identifier: NCT01829295.",2020,"There was no significant difference in ∆CD4 between MMF and MTX at 6 months (-31.7 cells/μL for MMF compared to MTX; 95% CI: -358.2 to 294.8,  P  = .85) and 12 months (-78.3 cells/μL for MMF compared to MTX; 95% CI: -468.0 to 311.3;  P  = .69).
","['Individuals with CD4 counts at baseline, 6 months (or treatment failure prior), and 12 months (or treatment failure between 6 and 12\xa0months) were included', 'Patients', 'uveitis patients treated with']","['MMF', 'Mycophenolate Mofetil versus Methotrexate', 'mycophenolate mofetil (MMF) and methotrexate (MTX', 'MMF or 25 mg weekly MTX']","['∆CD4', '∆CD4 between MMF and MTX', 'CD4 lymphopenia']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}]",,0.152927,"There was no significant difference in ∆CD4 between MMF and MTX at 6 months (-31.7 cells/μL for MMF compared to MTX; 95% CI: -358.2 to 294.8,  P  = .85) and 12 months (-78.3 cells/μL for MMF compared to MTX; 95% CI: -468.0 to 311.3;  P  = .69).
","[{'ForeName': 'Christina L', 'Initials': 'CL', 'LastName': 'Kong', 'Affiliation': 'F.I. Proctor Foundation, University of California, San Francisco , San Francisco, CA, USA.'}, {'ForeName': 'Nicole K', 'Initials': 'NK', 'LastName': 'Kelly', 'Affiliation': 'F.I. Proctor Foundation, University of California, San Francisco , San Francisco, CA, USA.'}, {'ForeName': 'Miel', 'Initials': 'M', 'LastName': 'Sundararajan', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco , San Francisco, CA, USA.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Rathinam', 'Affiliation': 'Uvea Services, Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology , Madurai, India.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Gonzales', 'Affiliation': 'F.I. Proctor Foundation, University of California, San Francisco , San Francisco, CA, USA.'}, {'ForeName': 'Radhika', 'Initials': 'R', 'LastName': 'Thundikandy', 'Affiliation': 'Uvea Services, Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology , Madurai, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Vedhanayaki', 'Affiliation': 'Uvea Services, Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology , Madurai, India.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Kanakath', 'Affiliation': 'Uvea Services, Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology , Coimbatore, India.'}, {'ForeName': 'Bala', 'Initials': 'B', 'LastName': 'Murugan', 'Affiliation': 'Uvea Services, Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology , Pondicherry, India.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Doan', 'Affiliation': 'F.I. Proctor Foundation, University of California, San Francisco , San Francisco, CA, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Goldstein', 'Affiliation': 'Department of Ophthalmology, Northwestern University , Chicago, IL, USA.'}, {'ForeName': 'Hassan A', 'Initials': 'HA', 'LastName': 'Al-Dhibi', 'Affiliation': 'Division of Vitreoretinal Surgery and Uveitis, King Khaled Eye Specialist Hospital , Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Nisha R', 'Initials': 'NR', 'LastName': 'Acharya', 'Affiliation': 'F.I. Proctor Foundation, University of California, San Francisco , San Francisco, CA, USA.'}]",Ocular immunology and inflammation,['10.1080/09273948.2020.1774906']
1889,32779967,Ten kHz spinal cord stimulation treatment for painful diabetic neuropathy: results from post-hoc analysis of SENZA-PPN study.,"Aim:  Previous studies of 10 kHz spinal cord stimulation demonstrated its safety and efficacy for treatment of neuropathic pain of the trunk and/or limbs. This study analyzed data from a subset of subjects with painful diabetic neuropathy enrolled in a prospective, multicenter study of peripheral polyneuropathy with various etiologies.  Materials & methods:  Of the eight subjects that had permanent devices, seven attended the 12-month follow-up assessment.  Results & conclusion:  At 12 months, 6/7 subjects were treatment responders (≥50% pain relief) and had pain remission (visual analog scale ≤ 3.0 cm). Worsening of neurologic deficits was not reported in any subject. Instead, 5/7 subjects showed improvements in sensory testing and/or reflexes. These results support further investigation of 10 kHz spinal cord stimulation as a safe and effective treatment for intractable painful diabetic neuropathy.",2020,Worsening of neurologic deficits was not reported in any subject.,"['neuropathic pain of the trunk and/or limbs', 'painful diabetic neuropathy', 'subjects with painful diabetic neuropathy enrolled in a prospective, multicenter study of peripheral polyneuropathy with various etiologies', 'eight subjects that had permanent devices']","['10\xa0kHz spinal cord stimulation', 'kHz spinal cord stimulation', 'kHz\xa0spinal cord stimulation treatment']","['Worsening of neurologic deficits', 'pain remission', 'sensory testing and/or reflexes']","[{'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0751074', 'cui_str': 'Neuralgia, Diabetic'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Studies'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0556965', 'cui_str': 'kHz'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0200116', 'cui_str': 'Sensory testing'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}]",,0.0351065,Worsening of neurologic deficits was not reported in any subject.,"[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Galan', 'Affiliation': 'Georgia Pain Care, Stockbridge, GA 30281, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Scowcroft', 'Affiliation': ""KC Pain Centers, Lee's Summit, MO 64086, USA.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Chang', 'Affiliation': 'Georgia Pain Care, Stockbridge, GA 30281, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Premier Pain Centers, Shrewsbury, NJ 20852, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Staats', 'Affiliation': 'Premier Pain Centers, Shrewsbury, NJ 20852, USA.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Rotte', 'Affiliation': 'Nevro Corp., Redwood City, CA 94065, USA.'}, {'ForeName': 'Jeyakumar', 'Initials': 'J', 'LastName': 'Subbaroyan', 'Affiliation': 'Nevro Corp., Redwood City, CA 94065, USA.'}]",Pain management,['10.2217/pmt-2020-0033']
1890,32780015,Effects of trazodone versus cognitive behavioral therapy in the insomnia with short sleep duration phenotype: a preliminary study.,"STUDY OBJECTIVES


The insomnia with objective short sleep duration (ISS) phenotype, is associated with increased risk for adverse health outcomes, physiological hyperarousal, and a blunted response to Cognitive-Behavioral Treatment for Insomnia (CBT-I). Whether ISS responds better to pharmacological compared to CBT-I has not been examined.
METHODS


Participants included 15 chronic insomniacs (86.7% female) 45.3 ± 8.1 years old. Eight patients were randomized to CBT-I and seven to trazodone. Patients were examined with two weeks actigraphy, salivary cortisol, and the insomnia severity index (ISI) at three time points (pre-treatment, 3-month post-treatment, and 6-month follow-up). Mixed between-within subjects analysis of variance and univariate analysis of covariance were conducted to assess the impact of trazodone and CBT-I on patients' total sleep time (TST), salivary cortisol, and ISI scores across three time points.
RESULTS


Trazodone, but not CBT-I, significantly lengthened TST (when measured with actigraphy) both at post-treatment (51.01 versus -11.73 minutes; p = 0.051, Cohen's d = 1.383) and at follow-up (50.35 versus -7.56 minutes; p = 0.012, Cohen's d = 1.725) respectively. Additionally, trazodone, but not CBT-I, had a clinically meaningful decrease in salivary cortisol from pre-treatment to post-treatment (-36.07% versus -11.70%; Cohen's d = 0.793) and to follow-up (-21.37% versus -5.79%; Cohen's d = 0.284) respectively. Finally, there were no differences on ISI scores between trazodone and CBT-I groups.
CONCLUSIONS


The current preliminary, open-label, randomized trial suggests that trazodone, but not CBT-I, significantly improves objective sleep duration and reduces HPA axis activation, suggesting a differential treatment response in the ISS phenotype.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Identifier: NCT01348542.",2020,"RESULTS


Trazodone, but not CBT-I, significantly lengthened TST (when measured with actigraphy) both at post-treatment (51.01 versus -11.73 minutes; p = 0.051, Cohen's d = 1.383) and at follow-up (50.35 versus -7.56 minutes; p = 0.012, Cohen's d = 1.725) respectively.","['Participants included 15 chronic insomniacs (86.7% female) 45.3 ± 8.1 years old', 'insomnia with short sleep duration phenotype']","['trazodone', 'cognitive behavioral therapy']","['salivary cortisol', 'ISI scores', 'lengthened TST', 'actigraphy, salivary cortisol, and the insomnia severity index (ISI', 'total sleep time (TST), salivary cortisol, and ISI scores', 'objective sleep duration and reduces HPA axis activation']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}]","[{'cui': 'C0040805', 'cui_str': 'Trazodone'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C4706228', 'cui_str': 'ISI (Insomnia Severity Index) score'}, {'cui': 'C0392744', 'cui_str': 'Lengthened'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0085355', 'cui_str': 'Platelet-specific antigen'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}]",15.0,0.0519545,"RESULTS


Trazodone, but not CBT-I, significantly lengthened TST (when measured with actigraphy) both at post-treatment (51.01 versus -11.73 minutes; p = 0.051, Cohen's d = 1.383) and at follow-up (50.35 versus -7.56 minutes; p = 0.012, Cohen's d = 1.725) respectively.","[{'ForeName': 'Alexandros N', 'Initials': 'AN', 'LastName': 'Vgontzas', 'Affiliation': 'Sleep Research & Treatment Center, Penn State Health Milton S. Hershey Medical Center, Pennsylvania State University, College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Puzino', 'Affiliation': 'Sleep Research & Treatment Center, Penn State Health Milton S. Hershey Medical Center, Pennsylvania State University, College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Fernandez-Mendoza', 'Affiliation': 'Sleep Research & Treatment Center, Penn State Health Milton S. Hershey Medical Center, Pennsylvania State University, College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Venkatesh Basappa', 'Initials': 'VB', 'LastName': 'Krishnamurthy', 'Affiliation': 'Sleep Research & Treatment Center, Penn State Health Milton S. Hershey Medical Center, Pennsylvania State University, College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Basta', 'Affiliation': 'Department of Psychiatry, University of Crete, University Hospital of Heraklion, Heraklion, Crete, Greece.'}, {'ForeName': 'Edward O', 'Initials': 'EO', 'LastName': 'Bixler', 'Affiliation': 'Sleep Research & Treatment Center, Penn State Health Milton S. Hershey Medical Center, Pennsylvania State University, College of Medicine, Hershey, Pennsylvania.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8740']
1891,32780139,"Effect of High Add Power, Medium Add Power, or Single-Vision Contact Lenses on Myopia Progression in Children: The BLINK Randomized Clinical Trial.","Importance


Slowing myopia progression could decrease the risk of sight-threatening complications.
Objective


To determine whether soft multifocal contact lenses slow myopia progression in children, and whether high add power (+2.50 D) slows myopia progression more than medium (+1.50 D) add power lenses.
Design, Setting, and Participants


A double-masked randomized clinical trial that took place at 2 optometry schools located in Columbus, Ohio, and Houston, Texas. A total of 294 consecutive eligible children aged 7 to 11 years with -0.75 D to -5.00 D of spherical component myopia and less than 1.00 D astigmatism were enrolled between September 22, 2014, and June 20, 2016. Follow-up was completed June 24, 2019.
Interventions


Participants were randomly assigned to wear high add power (n = 98), medium add power (n = 98), or single-vision (n = 98) contact lenses.
Main Outcomes and Measures


The primary outcome was the 3-year change in cycloplegic spherical equivalent autorefraction, as measured by the mean of 10 autorefraction readings. There were 11 secondary end points, 4 of which were analyzed for this study, including 3-year eye growth.
Results


Among 294 randomized participants, 292 (99%) were included in the analyses (mean [SD] age, 10.3 [1.2] years; 177 [60.2%] were female; mean [SD] spherical equivalent refractive error, -2.39 [1.00] D). Adjusted 3-year myopia progression was -0.60 D for high add power, -0.89 D for medium add power, and -1.05 D for single-vision contact lenses. The difference in progression was 0.46 D (95% CI, 0.29-0.63) for high add power vs single vision, 0.30 D (95% CI, 0.13-0.47) for high add vs medium add power, and 0.16 D (95% CI, -0.01 to 0.33) for medium add power vs single vision. Of the 4 secondary end points, there were no statistically significant differences between the groups for 3 of the end points. Adjusted mean eye growth was 0.42 mm for high add power, 0.58 mm for medium add power, and 0.66 mm for single vision. The difference in eye growth was -0.23 mm (95% CI, -0.30 to -0.17) for high add power vs single vision, -0.16 mm (95% CI, -0.23 to -0.09) for high add vs medium add power, and -0.07 mm (95% CI, -0.14 to -0.01) for medium add power vs single vision.
Conclusions and Relevance


Among children with myopia, treatment with high add power multifocal contact lenses significantly reduced the rate of myopia progression over 3 years compared with medium add power multifocal and single-vision contact lenses. However, further research is needed to understand the clinical importance of the observed differences.
Trial Registration


ClinicalTrials.gov Identifier: NCT02255474.",2020,"Adjusted 3-year myopia progression was -0.60 D for high add power, -0.89 D for medium add power, and -1.05 D for single-vision contact lenses.","['294 consecutive eligible children aged 7 to 11 years with -0.75 D to -5.00 D of spherical component myopia and less than 1.00 D astigmatism were enrolled between September 22, 2014, and June 20, 2016', 'Children', 'children with myopia', '294 randomized participants, 292 (99%) were included in the analyses (mean\u2009[SD] age, 10.3\u2009[1.2] years; 177 [60.2%] were female; mean [SD] spherical equivalent refractive error, -2.39']","['single-vision (n\u2009=\u200998) contact lenses', 'High Add Power, Medium Add Power, or Single-Vision Contact Lenses']","['rate of myopia progression', 'progression', '3-year eye growth', 'Adjusted 3-year myopia progression', '3-year change in cycloplegic spherical equivalent autorefraction, as measured by the mean of 10 autorefraction readings', 'eye growth']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1275644', 'cui_str': 'Reading addition power'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}]","[{'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0010586', 'cui_str': 'Cycloplegic preparation'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]",294.0,0.396685,"Adjusted 3-year myopia progression was -0.60 D for high add power, -0.89 D for medium add power, and -1.05 D for single-vision contact lenses.","[{'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Walline', 'Affiliation': 'The Ohio State University College of Optometry; Columbus.'}, {'ForeName': 'Maria K', 'Initials': 'MK', 'LastName': 'Walker', 'Affiliation': 'University of Houston College of Optometry; Houston, Texas.'}, {'ForeName': 'Donald O', 'Initials': 'DO', 'LastName': 'Mutti', 'Affiliation': 'The Ohio State University College of Optometry; Columbus.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Jones-Jordan', 'Affiliation': 'The Ohio State University College of Optometry; Columbus.'}, {'ForeName': 'Loraine T', 'Initials': 'LT', 'LastName': 'Sinnott', 'Affiliation': 'The Ohio State University College of Optometry; Columbus.'}, {'ForeName': 'Amber Gaume', 'Initials': 'AG', 'LastName': 'Giannoni', 'Affiliation': 'University of Houston College of Optometry; Houston, Texas.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Bickle', 'Affiliation': 'The Ohio State University College of Optometry; Columbus.'}, {'ForeName': 'Krystal L', 'Initials': 'KL', 'LastName': 'Schulle', 'Affiliation': 'University of Houston College of Optometry; Houston, Texas.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Nixon', 'Affiliation': 'The Ohio State University College of Optometry; Columbus.'}, {'ForeName': 'Gilbert E', 'Initials': 'GE', 'LastName': 'Pierce', 'Affiliation': 'The Ohio State University College of Optometry; Columbus.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Berntsen', 'Affiliation': 'University of Houston College of Optometry; Houston, Texas.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.10834']
1892,32780166,"Combination therapy of vitamin C and thiamine for septic shock: a multi-centre, double-blinded randomized, controlled study.","PURPOSE


To evaluate the effects of early combination therapy with intravenous vitamin C and thiamine on recovery from organ failure in patients with septic shock.
METHODS


The ascorbic acid and thiamine effect in septic shock (ATESS) trial was a multi-centre, double-blind, randomized, controlled trial conducted in four academic emergency departments, enrolling adult patients with septic shock from December 2018 through January 2020. Patients were randomly assigned in a 1:1 ratio to either the treatment group [intravenous vitamin C (50 mg/kg, maximum single dose 3 g) and thiamine (200 mg) administration every 12 h for a total of 48 h] or the placebo group (identical volume of 0.9% saline with the same protocol). The primary outcome was Δ Sequential Organ Failure Assessment (SOFA) score (SOFA score at enrolment-SOFA score after 72 h). Eighteen secondary outcomes were predefined, including shock reversal and 28-day mortality.
RESULTS


A total of 111 patients were enrolled, of which 53 were assigned to the treatment group and 58 were assigned to the placebo group. There was no significant difference in ΔSOFA scores between the treatment group and the placebo group [3, interquartile range (IQR) - 1 to 5 vs. 3, IQR 0-4, respectively, p = 0.96]. Predefined secondary outcomes were also not significantly different between the groups.
CONCLUSION


In this study, vitamin C and thiamine administration in the early phase of septic shock did not improve organ function compared with placebo, despite improvements in vitamin C and thiamine levels.",2020,"There was no significant difference in ΔSOFA scores between the treatment group and the placebo group [3, interquartile range (IQR) - 1 to 5 vs. 3, IQR 0-4, respectively, p = 0.96].","['septic shock', 'patients with septic shock', 'four academic emergency departments, enrolling adult patients with septic shock from December 2018 through January 2020', 'A total of 111 patients were enrolled, of which 53 were assigned to the treatment group and 58 were assigned to the']","['ascorbic acid and thiamine', 'thiamine', 'vitamin C and thiamine', 'intravenous vitamin C', 'placebo']","['ΔSOFA scores', 'Sequential Organ Failure Assessment (SOFA) score (SOFA score at enrolment-SOFA score', 'organ function', 'vitamin C and thiamine levels', 'shock reversal and 28-day mortality']","[{'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",111.0,0.826426,"There was no significant difference in ΔSOFA scores between the treatment group and the placebo group [3, interquartile range (IQR) - 1 to 5 vs. 3, IQR 0-4, respectively, p = 0.96].","[{'ForeName': 'Sung Yeon', 'Initials': 'SY', 'LastName': 'Hwang', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Korea.'}, {'ForeName': 'Seung Mok', 'Initials': 'SM', 'LastName': 'Ryoo', 'Affiliation': 'Department of Emergency Medicine, Asan Medical Centre, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 138-736, Korea.'}, {'ForeName': 'Jong Eun', 'Initials': 'JE', 'LastName': 'Park', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Korea.'}, {'ForeName': 'You Hwan', 'Initials': 'YH', 'LastName': 'Jo', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Bundang Hospital, Songnam, Korea.'}, {'ForeName': 'Dong-Hyun', 'Initials': 'DH', 'LastName': 'Jang', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Bundang Hospital, Songnam, Korea.'}, {'ForeName': 'Gil Joon', 'Initials': 'GJ', 'LastName': 'Suh', 'Affiliation': 'Department of Emergency Medicine, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Taegyun', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Youn-Jung', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Asan Medical Centre, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 138-736, Korea.'}, {'ForeName': 'Seonwoo', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Statistics and Data Centre, Samsung Medical Centre, Seoul, Korea.'}, {'ForeName': 'Hyun', 'Initials': 'H', 'LastName': 'Cho', 'Affiliation': 'Statistics and Data Centre, Samsung Medical Centre, Seoul, Korea.'}, {'ForeName': 'Ik Joon', 'Initials': 'IJ', 'LastName': 'Jo', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Korea.'}, {'ForeName': 'Sung Phil', 'Initials': 'SP', 'LastName': 'Chung', 'Affiliation': 'Department of Emergency Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sung-Hyuk', 'Initials': 'SH', 'LastName': 'Choi', 'Affiliation': 'Department of Emergency Medicine, Guro Hospital, Korea University Medical Centre, Seoul, Korea.'}, {'ForeName': 'Tae Gun', 'Initials': 'TG', 'LastName': 'Shin', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Korea. taegunshin@skku.edu.'}, {'ForeName': 'Won Young', 'Initials': 'WY', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Asan Medical Centre, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 138-736, Korea. wonpia73@naver.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-020-06191-3']
1893,32780237,SpyGlass-guided laser lithotripsy versus laparoscopic common bile duct exploration for large common bile duct stones: a non-inferiority trial.,"BACKGROUND


Laparoscopic common bile duct exploration (LCBDE) is the first choice of treatment for large common bile duct (CBD) stones. Recently, single-operator cholangioscopy (SpyGlass system) has been introduced widely in referral and large medical centers. Several studies have reported favorable results for treatment of large CBD stones guided by SpyGlass. We evaluated the clinical efficacy and safety of SpyGlass-guided laser lithotripsy LCBDE for treatment of large CBD stones.
METHODS


From August 2015 to August 2018, 157 patients with large bile duct stones who met the inclusion criteria were randomly divided into two groups: SpyGlass-guided laser lithotripsy (Group A) and LCBDE (Group B). The efficacy and complications were compared between the groups.
RESULTS


Although the first-session stone removal rate in Group A was significantly lower than that in Group B, Group A was not inferior to Group B in terms of total stone removal rate. Compared with Group B, Group A had shorter hospital stay and enhanced recovery. The short-term complication rates were also similar between the two groups.
CONCLUSIONS


The clinical efficacy of SpyGlass-guided laser lithotripsy for the treatment of large CBD stones is not inferior to that of LCBDE, and it is less invasive. SpyGlass-guided laser lithotripsy is an important option for treatment of large CBD stones.",2020,"The clinical efficacy of SpyGlass-guided laser lithotripsy for the treatment of large CBD stones is not inferior to that of LCBDE, and it is less invasive.","['157 patients with large bile duct stones who met the inclusion criteria', 'large common bile duct (CBD) stones', 'From August 2015 to August 2018']","['SpyGlass-guided laser lithotripsy', 'SpyGlass-guided laser lithotripsy (Group A) and LCBDE', 'SpyGlass-guided laser lithotripsy LCBDE', 'Laparoscopic common bile duct exploration (LCBDE', 'SpyGlass-guided laser lithotripsy versus laparoscopic common bile duct exploration']","['efficacy and complications', 'clinical efficacy and safety', 'shorter hospital stay and enhanced recovery', 'short-term complication rates', 'stone removal rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0267869', 'cui_str': 'Calculus of bile duct'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0009437', 'cui_str': 'Common bile duct structure'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0015327', 'cui_str': 'Choledochotomy and exploration'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]",157.0,0.0301174,"The clinical efficacy of SpyGlass-guided laser lithotripsy for the treatment of large CBD stones is not inferior to that of LCBDE, and it is less invasive.","[{'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of Endoscopy, the First Affiliated Hospital of Shandong First Medical, University, 250014, Jinan, China.'}, {'ForeName': 'Qiuping', 'Initials': 'Q', 'LastName': 'Pang', 'Affiliation': 'Department of Endoscopy, the First Affiliated Hospital of Shandong First Medical, University, 250014, Jinan, China. pangqiuping123@163.com.'}, {'ForeName': 'Hailan', 'Initials': 'H', 'LastName': 'Zhai', 'Affiliation': 'Department of Endoscopy, the First Affiliated Hospital of Shandong First Medical, University, 250014, Jinan, China.'}, {'ForeName': 'Xiujuan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Endoscopy, the First Affiliated Hospital of Shandong First Medical, University, 250014, Jinan, China.'}, {'ForeName': 'Yanchun', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Endoscopy, the First Affiliated Hospital of Shandong First Medical, University, 250014, Jinan, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Hepatobiliary Surgery, The First Affiliated Hospital of Shandong First Medical University, 250014, Jinan, China.'}, {'ForeName': 'Xinyong', 'Initials': 'X', 'LastName': 'Jia', 'Affiliation': 'Department of Endoscopy, the First Affiliated Hospital of Shandong First Medical, University, 250014, Jinan, China. jiaxy0505@126.com.'}]",Surgical endoscopy,['10.1007/s00464-020-07862-4']
1894,32780258,"Effects of Probiotics Supplementation on Gastrointestinal Symptoms and SIBO after Roux-en-Y Gastric Bypass: a Prospective, Randomized, Double-Blind, Placebo-Controlled Trial.","Bariatric surgery may cause undesirable gastrointestinal symptoms due to anatomical, functional and intestinal microbiota changes.
PURPOSE


The aim of this study was to evaluate the effect of probiotic supplementation on gastrointestinal symptoms and small intestine bacterial overgrowth (SIBO) in patients after Roux-en-Y gastric bypass (RYGB).
MATERIALS AND METHODS


This is a prospective, randomized, double-blind, placebo-controlled trial. The patients were randomized into Control Group (CG) (n = 39) and Probiotic Group (PG) (n = 34). The PG received tablets containing Lactobacillus acidophilus and Bifidobaterium lactis (5 billion CFU/strain) for 90 days, and the CG received tablets with starch. Both the Gastric Symptom Rating Scale (GSRS) questionnaire and 3-day food record were answered before surgery (T0) and after 45 days (T1) and 90 days of surgery (T2). At T0 and T2, hydrogen breath test was used to verify the presence of SIBO.
RESULTS


The prevalence of SIBO was similar among times, and the mean score of GSRS responses did not differ between groups at any time. However, PG patients reported less bloating compared to CG, more abdominal pain at T1 (which reduced at T2), more episodes of soft stools and nausea and less hunger pain after surgery, with no reports of urgent episodes to evacuate, even though they consumed more fat than the CG.
CONCLUSIONS


The supplementation of L. acidophilus and B. lactis is effective in reducing bloating, but without influencing the development of SIBO in the early postoperative period.",2020,"The prevalence of SIBO was similar among times, and the mean score of GSRS responses did not differ between groups at any time.","['after Roux-en-Y Gastric Bypass', 'patients after Roux-en-Y gastric bypass (RYGB']","['Control Group (CG', 'Placebo', 'Probiotics Supplementation', 'probiotic supplementation', 'Probiotic Group (PG', 'placebo']","['mean score of GSRS responses', 'prevalence of SIBO', 'episodes of soft stools and nausea', 'gastrointestinal symptoms and small intestine bacterial overgrowth (SIBO', 'Gastric Symptom Rating Scale (GSRS) questionnaire and 3-day food record', 'bloating', 'Gastrointestinal Symptoms and SIBO', 'abdominal pain', 'hunger pain']","[{'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0429688', 'cui_str': 'Symptom ratings'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0151521', 'cui_str': 'Bacterial resistance'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0577115', 'cui_str': 'Soft stool'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0581870', 'cui_str': 'Hunger pain'}]",,0.302262,"The prevalence of SIBO was similar among times, and the mean score of GSRS responses did not differ between groups at any time.","[{'ForeName': 'Nathalia Ramori Farinha', 'Initials': 'NRF', 'LastName': 'Wagner', 'Affiliation': 'Nutrition Department (Nassif Clinic), Santa Casa de Misericórdia de Curitiba Hospital, Rua Bruno Filgueira, 485 - Batel, 80240-220,, Curitiba, Paraná, Brazil. nathalia_farinha@yahoo.con.br.'}, {'ForeName': 'Marilia Rizzon Zaparolli', 'Initials': 'MRZ', 'LastName': 'Ramos', 'Affiliation': 'Clinical Surgery Department, Federal University of Parana, Curitiba, Brazil.'}, {'ForeName': 'Ligia', 'Initials': 'L', 'LastName': 'de Oliveira Carlos', 'Affiliation': 'Clinical Surgery Department, Federal University of Parana, Curitiba, Brazil.'}, {'ForeName': 'Magda Rosa Ramos', 'Initials': 'MRR', 'LastName': 'da Cruz', 'Affiliation': 'Pontifical Catholic University of Paraná (PUCPR), Curitiba, Brazil.'}, {'ForeName': 'Cesar Augusto', 'Initials': 'CA', 'LastName': 'Taconeli', 'Affiliation': 'Department of Statistics, Federal University of Paraná, Curitiba, Brazil.'}, {'ForeName': 'Alcides José Branco', 'Initials': 'AJB', 'LastName': 'Filho', 'Affiliation': 'Santa Casa de Misericórdia de Curitiba Hospital, Curitiba, Brazil.'}, {'ForeName': 'Luis Sergio', 'Initials': 'LS', 'LastName': 'Nassif', 'Affiliation': 'Santa Casa de Misericórdia de Curitiba Hospital, Curitiba, Brazil.'}, {'ForeName': 'Maria Eliana Madalozzo', 'Initials': 'MEM', 'LastName': 'Schieferdecker', 'Affiliation': 'Nutrition Department, Federal University of Parana, Curitiba, Brazil.'}, {'ForeName': 'Antônio Carlos Ligocki', 'Initials': 'ACL', 'LastName': 'Campos', 'Affiliation': 'Clinical Surgery Department, Federal University of Parana, Curitiba, Brazil.'}]",Obesity surgery,['10.1007/s11695-020-04900-x']
1895,32780476,Effects of interphase interval during neuromuscular electrical stimulation of the wrist extensors with maximally tolerated current intensity.,"BACKGROUND


Short interphase intervals (IPIs) within biphasic symmetrical pulses enhance maximally electrically induced isometric contractions (EIC). However, IPI effects have not been previously studied in muscles stimulated at the highest tolerated current intensity.
AIM


To examine IPI effects on the strength of EIC, degree of discomfort, and sensory and motor thresholds on the wrist extensor muscles.
METHODS


Eighteen subjects (mean age 25.5, SD±3.97 years) participated in a repeated-measures trial. Five parameter settings were used to stimulate the wrist extensors: monophasic pulses with phase durations (PD) 200µs, and biphasic pulses with PDs either 200µs or 500 µs, applied with/without an IPI of 200µs duration. Order of settings was randomized, and current was set at the maximum intensity tolerated by each subject.
RESULTS


IPIs applied at the maximally tolerated current intensity did not increase the strength of the EICs and did not reduce the degree of discomfort or the sensory and motor thresholds. These findings were not dependent on the PDs.
CONCLUSION


Insertion of an IPI within the biphasic current during stimulation of the wrist muscle yielded no advantage in term of contraction strength or degree of discomfort. These results contradict previous studies indicating stronger contractions when an IPI is inserted during stimulation at a predetermined submaximal current intensity. As some of the clinical applications of neuromuscular electrical stimulation utilize the highest intensity tolerated by the individual, these findings are clinically relevant. Additional studies involving other muscle groups, electrode size and locations, and phase parameters, are warranted.",2020,"RESULTS


IPIs applied at the maximally tolerated current intensity did not increase the strength of the EICs and did not reduce the degree of discomfort or the sensory and motor thresholds.","['Eighteen subjects (mean age 25.5, SD±3.97 years) participated in a repeated-measures trial']","['wrist extensors: monophasic pulses with phase durations (PD) 200µs, and biphasic pulses with PDs either 200µs or 500 µs, applied with/without an IPI of 200µs duration']","['strength of EIC, degree of discomfort, and sensory and motor thresholds', 'degree of discomfort or the sensory and motor thresholds', 'strength of the EICs', 'isometric contractions (EIC']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517663', 'cui_str': '25.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0205186', 'cui_str': 'Monophasic'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205184', 'cui_str': 'Biphasic'}, {'cui': 'C0271829', 'cui_str': ""Pendred's syndrome""}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0668760', 'cui_str': 'diinosine pentaphosphate'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",5.0,0.0342559,"RESULTS


IPIs applied at the maximally tolerated current intensity did not increase the strength of the EICs and did not reduce the degree of discomfort or the sensory and motor thresholds.","[{'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Elboim-Gabyzon', 'Affiliation': 'Physical Therapy Department, Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Yara', 'Initials': 'Y', 'LastName': 'Awad', 'Affiliation': 'Physical Therapy Department, Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel.'}]",Artificial organs,['10.1111/aor.13794']
1896,32773936,Does pre-procedure ultrasound increase the success and safety of right internal jugular venous catheterization? An intervention study.,"Background


Real-time ultrasound (US) in central venous catheterization is superior to pre-procedure US. However, ensuring real-time US into routine practice is impeded by its perceived expense and difficulty. This expertise requires hand-eye coordination and learning curve. Moreover, availability of multiple US machines and probes for multiple operation theatres may not be possible even at the tertiary level care set-up. Currently, pre-procedure US and landmark methods are most widely used. We investigated both the techniques with application of skin markings in the pre-procedure group to ascertain efficacy and safety with a view to incorporate pre-procedure US in our practice.
Methods


In this randomized study, we investigated 66 patients. Thirty-three patients in the pre-procedure ultrasound group and 33 patients in the landmark group were included for right internal jugular vein (RIJV) cannulation. We recorded the first needle pass success rate, cannulation time and complications.
Results


Pre-procedure US was associated with more successful attempts, shorter cannulation times and less complications. Under pre-procedure US, 75.76% of first attempts were successful with a cannulation time of 50 (25-180) seconds. Under landmark technique, 27.27% of first attempts were successful with a cannulation time of 85 (20-200) seconds. First puncture success rates were higher in pre-procedure US than landmark technique, 66.67% vs 27.27%, respectively.
Conclusion


Pre-procedure US for RIJV catheterization is safer, quicker and superior to landmark technique.",2020,"First puncture success rates were higher in pre-procedure US than landmark technique, 66.67% vs 27.27%, respectively.
",['66 patients'],['\n\n\nReal-time ultrasound (US'],"['cannulation time and complications', 'successful with a cannulation time', 'success and safety of right internal jugular venous catheterization', 'First puncture success rates', 'successful attempts, shorter cannulation times and less complications', 'right internal jugular vein (RIJV) cannulation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0398266', 'cui_str': 'Catheterization of vein'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}]",66.0,0.0318525,"First puncture success rates were higher in pre-procedure US than landmark technique, 66.67% vs 27.27%, respectively.
","[{'ForeName': 'Vikrant', 'Initials': 'V', 'LastName': 'Ghode', 'Affiliation': 'Graded Specialist (Anaesthesiology), Command Hospital (Western Command), C/o 56 APO, India.'}, {'ForeName': 'Naresh', 'Initials': 'N', 'LastName': 'Dhawan', 'Affiliation': 'Senior Adviser (Anaesthesia) & Cardiac Anaesthesiologist, Army Hospital (R & R), New Delhi, India.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Sharma', 'Affiliation': 'Consultant & HOD (Anaesthesia) & Critical Care, Army Hospital R & R, New Delhi, India.'}]","Medical journal, Armed Forces India",['10.1016/j.mjafi.2019.05.001']
1897,32773962,Concordance in the reporting of intimate partner violence among male-male couples.,"Intimate partner violence (IPV) among male couples is increasingly recognized as a public health concern. Research on IPV in opposite sex couples indicates frequent underreporting of IPV and high levels of discordance in reporting among dyads. Concordance studies inform refinement methods to measure the experience of IPV among dyads; however the lack of dyadic studies of male couples impedes our understanding of the extent to which IPV is differentially reported in male-male dyads. This study utilized baseline data from a randomized controlled trial of a behavioral intervention to optimize antiretroviral therapy (ART) adherence among 160 sero-discordant male couples in three US cities and provides the first analysis of concordance in reporting IPV among male couples. Low degrees of concordance in the reporting of IPV were identified among male dyads, with a greater proportion of men reporting violence perpetration than experiencing violence. The greater reporting of IPV perpetration may be linked to adherence to concepts of masculinity. The results underscore the unique experiences of IPV among male couples and the need to reexamine current IPV measurement and intervention strategies.",2019,"Low degrees of concordance in the reporting of IPV were identified among male dyads, with a greater proportion of men reporting violence perpetration than experiencing violence.","['male-male dyads', 'male-male couples', '160 sero-discordant male couples in three US cities', 'male couples']","['antiretroviral therapy (ART) adherence', 'behavioral intervention']",['Intimate partner violence (IPV'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]",,0.030709,"Low degrees of concordance in the reporting of IPV were identified among male dyads, with a greater proportion of men reporting violence perpetration than experiencing violence.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Stephenson', 'Affiliation': 'Department of Health Behavior and Biological Sciences, School of Nursing, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Department of Health Behavior and Biological Sciences, School of Nursing, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Mimiaga', 'Affiliation': 'Center for Health Equity Research, Brown University, Providence, RI, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Garofalo', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Brown', 'Affiliation': 'The Fenway Institute, Fenway Health, Boston, MA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bratcher', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Wimbly', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Hidalgo', 'Affiliation': ""Center for Trans Youth Health and Development, Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hoehnle', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Thai', 'Affiliation': 'Department of Pediatrics, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Sullivan', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Suarez', 'Affiliation': 'Department of Health Behavior and Health Education, University of Michigan School of Public Health, Ann Arbor, MI, USA.'}]",Journal of family violence,['10.1007/s10896-019-00076-w']
1898,32773964,"The Validity, Time Burden, and User Satisfaction of the FoodImage™ Smartphone App for Food Waste Measurement Versus Diaries: A Randomized Crossover Trial.","The FoodImage™ smartphone app transmits to researchers users' photographs of food selection and food waste, and includes user-tagged information about waste reasons and destination. Twenty-four participants were trained to record food waste using FoodImage, food waste diaries requiring visual estimation of waste quantities, and diaries requiring scale weights. Participants used each method during three staged food-waste scenarios (food preparation, eating, and clean-out) in a randomized crossover trial. Two participants had extreme values for the weighed diary method; therefore, accuracy results are reported with and without these two participants' data. Error was calculated as waste estimated with the experimental method minus directly weighed waste. Mean absolute error from FoodImage was significantly smaller than or equal to the error from both diary methods in each scenario. Furthermore, the mean values from FoodImage were equivalent to directly weighed values in two out of the three tasks; while weighed diaries were equivalent in two tasks only when the two participants with extreme values were removed. Visually estimated diaries were equivalent for only one task. All 24 participants preferred FoodImage to diaries and all rated FoodImage as less time consuming. Over one week, FoodImage would require ~24 fewer minutes of users' time to record all data. Unlike food waste diaries, FoodImage also transmits data to researchers in real-time and provides detailed data on food selection and intake. ClinicalTrials.gov Identifier: NCT03309306.",2020,Mean absolute error from FoodImage was significantly smaller than or equal to the error from both diary methods in each scenario.,[],['Measurement Versus Diaries'],"['Validity, Time Burden, and User Satisfaction of the FoodImage™ Smartphone App for Food Waste', 'Mean absolute error from FoodImage']",[],"[{'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]","[{'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",24.0,0.0709399,Mean absolute error from FoodImage was significantly smaller than or equal to the error from both diary methods in each scenario.,"[{'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Roe', 'Affiliation': 'Department of Agricultural, Environmental and Development Economics, Ohio State Univesity, 2120 Fyffe Road, Columbus, OH 43210 USA.'}, {'ForeName': 'Danyi', 'Initials': 'D', 'LastName': 'Qi', 'Affiliation': 'Department of Agricultural Economics and Agribusiness, Louisiana State University, Martin D. Woodin Hall, Baton Rouge, LA 70802 USA.'}, {'ForeName': 'Robbie A', 'Initials': 'RA', 'LastName': 'Beyl', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, 6400 Perkins Road, Baton Rouge, LA, 70808 USA.'}, {'ForeName': 'Karissa E', 'Initials': 'KE', 'LastName': 'Neubig', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, 6400 Perkins Road, Baton Rouge, LA, 70808 USA.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, 6400 Perkins Road, Baton Rouge, LA, 70808 USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Apolzan', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, 6400 Perkins Road, Baton Rouge, LA, 70808 USA.'}]","Resources, conservation, and recycling",['10.1016/j.resconrec.2020.104858']
1899,32774091,Use of Single- or Two-dose Pulse Methylprednisolone in the Treatment of Acute Immune Thrombocytopenic Purpura.,"Objectives


In immune thrombocytopenic purpura (ITP) treatment, the main goal is achieving the platelet level most rapidly for hemostasis. Pulse steroid therapy is common due to the rapid increase in the platelet count within the first 48 hours. Intravenous (IV) pulse steroid therapy is usually administered as a single methylprednisolone dose in the morning. Oral methylprednisolone is generally used as two divided doses due to its half-life, but there is no efficacy study for the use of pulse methylprednisolone therapy in two doses. In this study, we aimed to investigate whether the administration of single or double doses of pulse steroid treatment, which is the cheapest and most economical way to treat patients, differ in terms of platelet count increase rate.
Methods


The diagnosis of acute ITP was made based on the appropriate clinical, laboratory, and bone marrow findings and platelet count <100.000/mm 3 . All the patients were diagnosed with bone marrow aspiration, and they were admitted to the hospital. All patients with platelet counts below 20000/mm 3  and those who had wet purpura or active bleeding were treated. Patients in need of treatment were randomly divided into two treatment groups with closed envelope method. The first group was given IV pulse methylprednisolone (30 mg/kg/day for three days and 20 mg/kg/day for four days) in the early morning hours. The second group received the same daily dosages in two divided doses. Hemoglobin, white blood cell, and platelet counts were evaluated before and on the first, second, third, fifth, and seventh days of treatment. To evaluate the rate of treatment response, platelet counts over 20.000/mm 3 , 50.000/mm 3 , and 100.000/mm 3  obtained on the first, second, third, and seventh days of treatment were compared.
Results


Sixty patients with acute ITP diagnosis receiving pulse steroid therapy were included in the study. Platelet counts of the patients in group 2, who received pulse steroids in two doses, reached ≥20.000/mm³ on the second day [median, (2-3) days], ≥50.000/mm³ on the third day [median, (2.7-3.5) days], ≥100.000/mm³ on the fifth day [median, (3-5) days], which were significantly lower than the platelet counts of the patients in the first group on the third day [median, (2-5) days], fifth day [median, (4-7) days], and seventh day [median, (4-7) days], respectively (p<0.001, p<0.001, p=0.004).
Conclusion


This study shows that administration of IV pulse steroid therapy in two doses is more effective in increasing the platelet count in early period in patients with acute ITP, especially whose platelet count is less than 20.000/mm³, and when we prefer to increase the platelet counts rapidly due to risk of intracranial hemorrhage.",2018,"Platelet counts of the patients in group 2, who received pulse steroids in two doses, reached ≥20.000/mm³ on the second day [median, (2-3) days], ≥50.000/mm³ on the third day [median, (2.7-3.5) days], ≥100.000/mm³ on the fifth day [median, (3-5) days], which were significantly lower than the platelet counts of the patients in the first group on the third day [median, (2-5) days], fifth day [median, (4-7) days], and seventh day [median, (4-7) days], respectively (p<0.001, p<0.001, p=0.004).
","['All patients with platelet counts below 20000/mm 3  and those who had wet purpura or active bleeding were treated', 'patients with acute ITP', 'Patients in need of treatment', 'Sixty patients with acute ITP diagnosis receiving pulse steroid therapy were included in the study', 'patients were diagnosed with bone marrow aspiration, and they were admitted to the hospital', 'Acute Immune Thrombocytopenic Purpura']","['Pulse steroid therapy', 'Intravenous (IV) pulse steroid therapy', 'Oral methylprednisolone', 'Single- or Two-dose Pulse Methylprednisolone', 'IV pulse methylprednisolone', 'pulse steroids', 'pulse steroid treatment', 'IV pulse steroid therapy']","['platelet count', 'rate of treatment response, platelet counts', 'Hemoglobin, white blood cell, and platelet counts', 'platelet counts', 'Platelet counts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C4087426', 'cui_str': 'Wet purpura'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0398650', 'cui_str': 'Idiopathic thrombocytopenic purpura'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0398523', 'cui_str': 'Bone marrow aspiration procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0360556', 'cui_str': 'Methylprednisolone-containing product in oral dose form'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}]",60.0,0.0236729,"Platelet counts of the patients in group 2, who received pulse steroids in two doses, reached ≥20.000/mm³ on the second day [median, (2-3) days], ≥50.000/mm³ on the third day [median, (2.7-3.5) days], ≥100.000/mm³ on the fifth day [median, (3-5) days], which were significantly lower than the platelet counts of the patients in the first group on the third day [median, (2-5) days], fifth day [median, (4-7) days], and seventh day [median, (4-7) days], respectively (p<0.001, p<0.001, p=0.004).
","[{'ForeName': 'Ayşe Bozkurt', 'Initials': 'AB', 'LastName': 'Turhan', 'Affiliation': 'Department of Pediatric Hematology, Eskişehir Osmangazi University Faculty of Medicine, Eskişehir, Turkey.'}, {'ForeName': 'Zeynep Canan', 'Initials': 'ZC', 'LastName': 'Özdemir', 'Affiliation': 'Department of Pediatric Hematology, Eskişehir Osmangazi University Faculty of Medicine, Eskişehir, Turkey.'}, {'ForeName': 'Özcan', 'Initials': 'Ö', 'LastName': 'Bör', 'Affiliation': 'Department of Pediatric Hematology, Eskişehir Osmangazi University Faculty of Medicine, Eskişehir, Turkey.'}]",Sisli Etfal Hastanesi tip bulteni,['10.5350/SEMB.20171130112516']
1900,32774092,Long-term and Perioperative Outcomes of Laparoscopic and Open Surgery for Rectal Cancer.,"Objectives


The necessity of comparing oncologic results with the use of minimally invasive surgery in rectal cancer has arisen. The aim of the present study was to evaluate the treatment approach in rectal cancer and to compare the outcomes of laparoscopic and open surgery.
Methods


Patients who underwent surgery for rectal carcinoma between January 2006 and January 2016 in our institution were evaluated. The results were compared between the two groups according to open or laparoscopic surgery. Clinical characteristics, preoperative and postoperative results, pathological examination results, and disease-free survival rates were compared after the surgical procedure.
Results


A total of 121 patients were included in the study. Of the patients, 50 underwent open, and 71 underwent laparoscopic surgery. The median follow-up times were 56.75 months in the open surgery group and 55.2 months in the laparoscopic surgery group. Pathological examination revealed similar numbers of lymph nodes in both groups (p>0.05). The duration of hospital stay was statistically significantly lower in the open surgery group than in the laparoscopic group (p<0.05). The rates of disease-free survival were 74% in the open surgery group and 82.5% in the laparoscopic group, and no statistically significant difference was found (p>0.05).
Conclusion


There was no significant difference in complication and recurrence between laparoscopic and open surgery for rectal cancer in our study. The duration of hospital stay of patients was statistically significantly lower in the laparoscopic group than in the open surgery group. Laparoscopic or open surgical options could be preferred according to the clinical suitability of the patient, experience of the surgeon, and resources of the center in rectal cancer treatment.",2018,The duration of hospital stay was statistically significantly lower in the open surgery group than in the laparoscopic group (p<0.05).,"['Rectal Cancer', 'A total of 121 patients were included in the study', 'Patients who underwent surgery for rectal carcinoma between January 2006 and January 2016 in our institution were evaluated']","['laparoscopic and open surgery', 'Laparoscopic and Open Surgery', 'minimally invasive surgery', 'Laparoscopic or open surgical options', 'laparoscopic surgery']","['complication and recurrence', 'numbers of lymph nodes', 'Clinical characteristics, preoperative and postoperative results, pathological examination results, and disease-free survival rates', 'rates of disease-free survival', 'duration of hospital stay']","[{'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",121.0,0.0501024,The duration of hospital stay was statistically significantly lower in the open surgery group than in the laparoscopic group (p<0.05).,"[{'ForeName': 'Hüseyin Onur', 'Initials': 'HO', 'LastName': 'Aydın', 'Affiliation': 'Department of General Surgery, Baskent University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Ekici', 'Affiliation': 'Department of General Surgery, Baskent University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Feza Yarbuğ', 'Initials': 'FY', 'LastName': 'Karakayalı', 'Affiliation': 'Department of General Surgery, Baskent University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Tugan', 'Initials': 'T', 'LastName': 'Tezcaner', 'Affiliation': 'Department of General Surgery, Baskent University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Gonca', 'Initials': 'G', 'LastName': 'Özgün', 'Affiliation': 'Department of Pathology, Baskent University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Sedat', 'Initials': 'S', 'LastName': 'Yıldırım', 'Affiliation': 'Department of General Surgery, Baskent University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Gökhan', 'Initials': 'G', 'LastName': 'Moray', 'Affiliation': 'Department of General Surgery, Baskent University Faculty of Medicine, Ankara, Turkey.'}]",Sisli Etfal Hastanesi tip bulteni,['10.14744/SEMB.2017.04909']
1901,32774093,The Evaluation of Upper Airway Complications Secondary to Intubation: Cuff Pressure Manometer Versus Conventional Palpation Method.,"Objectives


General anesthesia is preferred in most otorhinolaryngologic surgeries. The aim of the present study was to evaluate upper airway complications secondary to intubation including sore throat, cough, dysphonia, and dysphagia considering endotracheal tube (ET) cuff pressure, tube diameter, and duration of intubation.
Methods


After the assignment of 67 patients to the study and control groups, ET cuff pressure was adjusted to be between 20 and 30 cm H 2 O using a cuff pressure manometer in the study group. In the control group, the cuff pressure was decided by the anesthesiologist using the conventional palpation method. Sore throat, cough, dysphonia, and dysphagia were compared between the groups at 4, 8, and 24 h postoperatively.
Results


Cuff pressure was significantly higher in the control group than in the study group. In the control group, sore throat was more frequently observed at 4, 8, and 24 h, whereas in the study group, cough and dysphonia were more often observed at 4 and 8 h. At 4 and 8 h, cough was found to be related to the duration of intubation.
Conclusion


Arrangement of cuff pressure using a cuff manometer is suggested to decrease complications of the upper airway secondary to intubation because of the higher rate of these complaints in patients whose cuff pressure is arranged by the conventional palpation method.",2018,"Sore throat, cough, dysphonia, and dysphagia were compared between the groups at 4, 8, and 24 h postoperatively.
",[],['Intubation: Cuff Pressure Manometer Versus Conventional Palpation Method'],"['sore throat', 'cuff pressure', 'ET cuff pressure', 'sore throat, cough, dysphonia, and dysphagia considering endotracheal tube (ET) cuff pressure, tube diameter, and duration of intubation', 'Cuff pressure', 'duration of intubation', 'cough and dysphonia', 'Sore throat, cough, dysphonia, and dysphagia']",[],"[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C2720530', 'cui_str': 'Manometer'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0180212', 'cui_str': 'Endotracheal tube cuff'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]",67.0,0.0180388,"Sore throat, cough, dysphonia, and dysphagia were compared between the groups at 4, 8, and 24 h postoperatively.
","[{'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Ünsal', 'Affiliation': 'Department of Otolaryngological, Şişli Etfal Training and Research Hospital, İstanbul, Turkey.'}, {'ForeName': 'Nurullah', 'Initials': 'N', 'LastName': 'Seyhun', 'Affiliation': 'Department of Otolaryngological, Şişli Etfal Training and Research Hospital, İstanbul, Turkey.'}, {'ForeName': 'Bilge', 'Initials': 'B', 'LastName': 'Türk', 'Affiliation': 'Department of Otolaryngological, Şişli Etfal Training and Research Hospital, İstanbul, Turkey.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Ekici', 'Affiliation': 'Department of Otolaryngological, Şişli Etfal Training and Research Hospital, İstanbul, Turkey.'}, {'ForeName': 'Hale', 'Initials': 'H', 'LastName': 'Dobrucalı', 'Affiliation': 'Department of Anesthesia and Reanimation, Şişli Etfal Training and Research Hospital, İstanbul, Turkey.'}, {'ForeName': 'Suat', 'Initials': 'S', 'LastName': 'Turgut', 'Affiliation': 'Department of Otolaryngological, Şişli Etfal Training and Research Hospital, İstanbul, Turkey.'}]",Sisli Etfal Hastanesi tip bulteni,['10.5350/SEMB.20171214085933']
1902,32774217,Assessment of Quality of Life in Postmenopausal Women with Early Breast Cancer Participating in the PACT Trial: The Impact of Additional Patient Information Material Packages and Patient Compliance.,"Background


Breast cancer patients' self-understanding of their disease can impact their quality of life (QoL); the relationship between compliance and QoL is poorly understood.
Patients and Methods


The Patient's Anastrozole Compliance to Therapy (PACT) program, a prospective, randomized study, investigated the effect of additional patient information material (IM) packages on compliance with adjuvant aromatase inhibitor (AI) therapy in postmenopausal women with hormone receptor-positive early breast cancer. The QoL subanalysis presented here examined the impact of IM packages on QoL and the association between QoL and compliance. European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-BR23 questionnaires were completed at baseline, 12 and 24 months, or study termination to assess health-related QoL and disease-related symptoms.
Results


Of the 4,844 patients randomized to standard therapy or standard therapy + IM packages (1:1), 4,253 were available for QoL analysis. No difference in QoL was observed between groups at baseline. IM packages did not have a statistically significant impact on patient QoL at the 12- or 24-month follow-up. Compliant patients experienced improvement in multiple items across the QLQ-C30 and QLQ-BR23 scales at 12 months. However, those results should be interpreted carefully due to limitations in the statistical analyses.
Conclusions


Provision of IM packages did not influence patients' QoL or satisfaction with care during AI therapy. Compliant patients appear to experience improved QoL compared to noncompliant patients, perhaps indicating a more self-empowered perception of their condition.",2020,IM packages did not have a statistically significant impact on patient QoL at the 12- or 24-month follow-up.,"['postmenopausal women with hormone receptor-positive early breast cancer', '4,844 patients randomized to', 'Postmenopausal Women with Early Breast Cancer Participating in the PACT Trial']","['standard therapy or standard therapy + IM packages', 'adjuvant aromatase inhibitor (AI) therapy', 'additional patient information material (IM) packages']","['QoL', 'Quality of Life', 'Cancer (EORTC) QLQ-C30 and QLQ-BR23 questionnaires', 'QLQ-C30 and QLQ-BR23 scales', 'patient QoL']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",4844.0,0.0440166,IM packages did not have a statistically significant impact on patient QoL at the 12- or 24-month follow-up.,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jackisch', 'Affiliation': 'Sana Klinikum Offenbach GmbH, Offenbach, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Kreienberg', 'Affiliation': 'University of Ulm, Ulm, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Blettner', 'Affiliation': 'Institute for Medical Biostatistics, Epidemiology and Informatics, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'Breast Center, University of Munich (LMU), Munich, Germany.'}, {'ForeName': 'Hans-Joachim', 'Initials': 'HJ', 'LastName': 'Lück', 'Affiliation': 'Gyn-Oncological Practice Hannover, Hannover, Germany.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Haidinger', 'Affiliation': 'Brustkrebs Deutschland e.V., Hohenbrunn, Germany.'}, {'ForeName': 'Doris C', 'Initials': 'DC', 'LastName': 'Schmitt', 'Affiliation': 'PATH Foundation, Munich, Germany.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Schulte', 'Affiliation': 'Frauenselbsthilfe nach Krebs e.V., Bonn, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Windemuth-Kieselbach', 'Affiliation': 'Alcedis GmbH, Giessen, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Zaun', 'Affiliation': 'AstraZeneca, Wedel, Germany.'}, {'ForeName': 'Peyman', 'Initials': 'P', 'LastName': 'Hadji', 'Affiliation': 'Frankfurt Center of Bone Health, Frankfurt, Germany.'}]","Breast care (Basel, Switzerland)",['10.1159/000500771']
1903,32774221,Influence of Incision Site on Postoperative Outcome in Skin-/Nipple-Sparing Mastectomy: Is There a Difference between Radial and Inframammary Incision?,"Background


The aim of this study was to determine whether there is a difference in results between the radial and the inframammary approach in nipple-/skin-sparing mastectomy and immediate reconstruction.
Methods


The patients were divided into two groups (group 1: radial incision; group 2: inframammary fold incision [IMF]), each consisting of two subgroups for direct-to-implant reconstruction (1a, 2a) and expander reconstruction (1b, 2b). The patients were operated on between March 2012 and May 2017. Preoperative tumor parameters, reconstruction parameters, postoperative tumor parameters, and immediate and late complications were assessed. Postoperative photographs were evaluated by the patients and 8 plastic surgeons by means of grading (1-5) and the visual analog scale (VAS; 1-10).
Results


Enrolled in this study were 28 patients, namely, 7 patients in each subgroup. The median age was 46 years, and the median follow-up period was 40 months. No immediate complications occurred. Three patients had late complications, but there was no case of evident capsular fibrosis. Twenty-seven patients (96.42%) evaluated the postoperative result as excellent/good. The postoperative evaluation by the plastic surgeons was excellent/good for a median of 18 patients (64.28%). Group 1 showed a median VAS score of 7.63 (expander group: 7.50; direct-to-implant group: 7.75); the median VAS score for group 2 was 8.25 (expander group: 8.75; direct-to-implant group: 7.50).
Conclusions


Our study shows good results for implant breast reconstruction in both groups, with minimally better results for the IMF group. In the direct-to-implant subgroups, the radial group showed slightly better results.",2020,The postoperative evaluation by the plastic surgeons was excellent/good for a median of 18 patients (64.28%).,"['Skin-/Nipple-Sparing Mastectomy', '28 patients, namely, 7 patients in each subgroup']","['direct-to-implant reconstruction (1a, 2a) and expander reconstruction', 'Incision Site', 'nipple-/skin-sparing mastectomy and immediate reconstruction', 'radial incision; group 2: inframammary fold incision [IMF']","['Preoperative tumor parameters, reconstruction parameters, postoperative tumor parameters, and immediate and late complications', 'median VAS score', 'late complications', 'visual analog scale', 'postoperative evaluation', 'Postoperative Outcome']","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0449681', 'cui_str': 'Site of incision'}, {'cui': 'C0028109', 'cui_str': 'Nipple structure'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0442099', 'cui_str': 'Inframammary'}, {'cui': 'C0185026', 'cui_str': 'Plication'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",28.0,0.0210977,The postoperative evaluation by the plastic surgeons was excellent/good for a median of 18 patients (64.28%).,"[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Lanthaler', 'Affiliation': 'Department of Plastic Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Spinelli', 'Affiliation': 'Department of Plastic Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Tasch', 'Affiliation': 'Department of Plastic Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sieb', 'Affiliation': 'Department of Mechatronics - Medical Engineering, Management Center Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Harfmann', 'Affiliation': 'Department of Plastic Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Agnese', 'Initials': 'A', 'LastName': 'Nitto', 'Affiliation': 'Department of Plastic Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Pierer', 'Affiliation': 'Department of Plastic Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bauer', 'Affiliation': 'Department of Plastic Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}]","Breast care (Basel, Switzerland)",['10.1159/000502408']
1904,32774362,Effect of Preoperative Vitamin D Deficiency on Hypocalcemia in Patients with Acute Hypoparathyroidism after Thyroidectomy.,"Postoperative hypoparathyroidism is a common complication of total or completion thyroidectomy. The association between preoperative vitamin D deficiency (VDD) and the development of more severe postoperative hypocalcemia is still unclear.  Objectives . To evaluate the effect of preoperative VDD on severity of hypocalcemia in patients with hypoparathyroidism following thyroidectomy.  Methods . Patients who developed acute hypoparathyroidism after total or completion thyroidectomy, defined as postoperative parathyroid hormone (PTH) level <15 pg/mL and albumin-adjusted calcium level <8.6 mg/dL, were prospectively recruited. Patients were divided into two groups according to their preoperative vitamin D status (VDD group: 25-hydroxyvitamin D (25(OH)D) level <20 ng/mL; non-VDD group: 25(OH) level ≥20 ng/mL). The primary outcome was severity of hypocalcemia in postoperative hypoparathyroidism. Significant hypocalcemia was defined as calcium level ≤7.5 mg/dL.  Results . Forty-three patients (21 VDD, 22 non-VDD) were enrolled. Serum total albumin-adjusted calcium level was significantly lower in the VDD group (7.71 ± 0.5 vs. 8.16 ± 0.4 mg/dL,  p  < 0.01), and the incidence of symptomatic hypocalcemia was significantly higher in the VDD group (43% vs. 9%,  p =0.01). The median maximal daily supplementary dose of elemental calcium was significantly higher in the VDD group (2,400 vs. 1,500 mg/day,  p =0.02). Length of hospital stay was nonsignificantly longer in the VDD group ( p =0.06). Preoperative vitamin D level <19.6 ng/mL could predict significant and symptomatic hypocalcemia in postoperative hypoparathyroidism with sensitivity of 90% and 82% and specificity of 70% and 69%, respectively.  Conclusion . VDD is an independent risk factor for both significant and symptomatic hypocalcemia in hypoparathyroidism patients after thyroid surgery.",2020,"Serum total albumin-adjusted calcium level was significantly lower in the VDD group (7.71 ± 0.5 vs. 8.16 ± 0.4 mg/dL,  p  < 0.01), and the incidence of symptomatic hypocalcemia was significantly higher in the VDD group (43% vs. 9%,  p =0.01).","['Patients with Acute Hypoparathyroidism after Thyroidectomy', 'hypoparathyroidism patients after thyroid surgery', 'patients with hypoparathyroidism following thyroidectomy', 'Patients who developed acute hypoparathyroidism after total or completion thyroidectomy, defined as postoperative parathyroid hormone (PTH) level <15\u2009pg/mL and albumin-adjusted calcium level <8.6\u2009mg/dL, were prospectively recruited', 'Forty-three patients (21 VDD, 22 non-VDD) were enrolled']","['preoperative VDD', 'preoperative vitamin D status (VDD group: 25-hydroxyvitamin D (25(OH)D) level <20\u2009ng/mL; non-VDD group: 25(OH) level ≥20\u2009ng/mL', 'Preoperative Vitamin D Deficiency']","['Serum total albumin-adjusted calcium level', 'median maximal daily supplementary dose of elemental calcium', 'severity of hypocalcemia in postoperative hypoparathyroidism', 'Length of hospital stay', 'symptomatic hypocalcemia', 'Preoperative vitamin D level', 'incidence of symptomatic hypocalcemia', 'severity of hypocalcemia', 'Significant hypocalcemia', 'Hypocalcemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0020626', 'cui_str': 'Hypoparathyroidism'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0193769', 'cui_str': 'Operation on thyroid gland'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4304448', 'cui_str': 'Completion thyroidectomy'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0201925', 'cui_str': 'Calcium measurement'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0201925', 'cui_str': 'Calcium measurement'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0342341', 'cui_str': 'Post-surgical hypoparathyroidism'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",,0.0986286,"Serum total albumin-adjusted calcium level was significantly lower in the VDD group (7.71 ± 0.5 vs. 8.16 ± 0.4 mg/dL,  p  < 0.01), and the incidence of symptomatic hypocalcemia was significantly higher in the VDD group (43% vs. 9%,  p =0.01).","[{'ForeName': 'Peeradon', 'Initials': 'P', 'LastName': 'Vibhatavata', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pongthep', 'Initials': 'P', 'LastName': 'Pisarnturakit', 'Affiliation': 'Division of Head and Neck Surgery, Department of Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Mongkol', 'Initials': 'M', 'LastName': 'Boonsripitayanon', 'Affiliation': 'Division of Head and Neck Surgery, Department of Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Paveena', 'Initials': 'P', 'LastName': 'Pithuksurachai', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Nattachet', 'Initials': 'N', 'LastName': 'Plengvidhya', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sirinart', 'Initials': 'S', 'LastName': 'Sirinvaravong', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",International journal of endocrinology,['10.1155/2020/5162496']
1905,32774397,Motivational Enhancement as a Pretreatment to a Transdiagnostic Intervention for Emerging Adults with Emotion Dysregulation: A Pilot Randomized Controlled Trial.,"Objective


New approaches are needed to help the large number of emerging adults (EA) presenting with early-stage mental health problems. The goal of this pilot study was to carry out a randomized controlled trial to investigate whether motivational enhancement therapy (MET) improved the treatment effects of a 12-week psychological intervention, Dialectical Behaviour Therapy Skills Training (DBT-ST), for EA presenting in the early stages of mental health difficulties. Participants were recruited from the Youth Wellness Centre at St. Joseph's Healthcare Hamilton and McMaster University's Student Wellness Centre in Hamilton, Canada.
Methods


Seventy-five participants were randomized to receive MET followed by DBT-ST or to DBT-ST alone. We assessed psychological distress, emotion dysregulation, and depression and anxiety symptoms as outcomes.
Results


We found that both treatment groups had significant reductions in emotional dysregulation, psychological distress, depression, and anxiety at post-treatment and at the three-month follow-up. Participants assigned to MET pre-treatment experienced greater improvement in psychological distress at the end of treatment.
Conclusion


This pilot study provides preliminary evidence of the potential augmentation of DBT-ST using MET in a real-world setting. Future studies should examine whether MET uniquely augments DBT-ST through the use of a comparable pre-treatment control group.",2020,"We found that both treatment groups had significant reductions in emotional dysregulation, psychological distress, depression, and anxiety at post-treatment and at the three-month follow-up.","[""Participants were recruited from the Youth Wellness Centre at St. Joseph's Healthcare Hamilton and McMaster University's Student Wellness Centre in Hamilton, Canada"", 'adults (EA) presenting with early-stage mental health problems', 'Methods\n\n\nSeventy-five participants', 'Adults with Emotion Dysregulation']","['DBT-ST or to DBT-ST alone', 'psychological intervention, Dialectical Behaviour Therapy Skills Training (DBT-ST', 'Transdiagnostic Intervention', 'motivational enhancement therapy (MET']","['psychological distress', 'emotional dysregulation, psychological distress, depression, and anxiety', 'psychological distress, emotion dysregulation, and depression and anxiety symptoms as outcomes']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]","[{'cui': 'C1321145', 'cui_str': 'Dialectical behavior therapy'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",75.0,0.0663981,"We found that both treatment groups had significant reductions in emotional dysregulation, psychological distress, depression, and anxiety at post-treatment and at the three-month follow-up.","[{'ForeName': 'Juliana I', 'Initials': 'JI', 'LastName': 'Tobon', 'Affiliation': ""Youth Wellness Centre, St. Joseph's Healthcare Hamilton, Hamilton, Ontario.""}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Zipursky', 'Affiliation': ""Youth Wellness Centre, St. Joseph's Healthcare Hamilton, Hamilton, Ontario.""}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Streiner', 'Affiliation': ""Department of Psychiatry and Behavioural Neurosciences, McMaster University, St. Joseph's Healthcare Hamilton, Hamilton, Ontario.""}, {'ForeName': 'Eamon', 'Initials': 'E', 'LastName': 'Colvin', 'Affiliation': 'School of Psychology, University of Ottawa, Ottawa, Ontario.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Bahl', 'Affiliation': 'School of Psychology, University of Ottawa, Ottawa, Ontario.'}, {'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Ouimet', 'Affiliation': 'School of Psychology, University of Ottawa, Ottawa, Ontario.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Burckell', 'Affiliation': ""Department of Psychiatry and Behavioural Neurosciences, McMaster University, St. Joseph's Healthcare Hamilton, Hamilton, Ontario.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Jeffs', 'Affiliation': ""Youth Wellness Centre, St. Joseph's Healthcare Hamilton, Hamilton, Ontario.""}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Bieling', 'Affiliation': ""Youth Wellness Centre, St. Joseph's Healthcare Hamilton, Hamilton, Ontario.""}]",Journal of the Canadian Academy of Child and Adolescent Psychiatry = Journal de l'Academie canadienne de psychiatrie de l'enfant et de l'adolescent,[]
1906,32774422,Clinical Efficacy and Safety of Yellow Oil Formulations 3 and 4 versus Indomethacin Solution in Patients with Symptomatic Osteoarthritis of the Knee: A Randomized Controlled Trial.,"Background


Topical nonsteroidal anti-inflammatory drugs (NSAIDs) are widely prescribed for the treatment of symptomatic osteoarthritis (OA) of the knee. However, searching for alternatives such as locally available medicinal herbs to manage OA knee pain remains of clinical value. The objective of the present study was to evaluate the efficacy and safety of two yellow oil formulations in patients with OA of the knee.
Methods


This prospective, randomized, single-blind, active-controlled, noninferiority study enrolled 102 patients with OA of the knee. Eligible patients were randomly assigned to apply either yellow oil formulation 3 (YOF3), yellow oil formulation 4 (YOF4), or indomethacin solution (INDO) topically four times daily for four weeks. Outcomes were assessed on a biweekly basis. The primary efficacy outcome measure was a 100 mm visual analog scale (VAS) of pain, while secondary endpoints included knee function, physical performance assessments, and safety parameters. Modified intention-to-treat and per-protocol analyses were applied. Assessment of noninferiority was done with a prespecified margin of 10 mm for VAS pain.
Results


Of 102 patients enrolled, 86 completed the study: 29/34 in the YOF3 group, 25/34 in the YOF4 group, and 32/34 in the INDO group. The absolute reduction in VAS pain at the final evaluation was -25.06 ± 13.91, -18.50 ± 16.06, and -23.38 ± 10.05 mm in the YOF3, YOF4, and INDO groups, respectively ( p =0.169). Only YOF3 was found to be noninferior to INDO. Other efficacy outcomes were significantly improved in all three groups. All the interventions were well tolerated; no skin rash was observed in any of the three groups.
Conclusions


YOF3 was shown to be noninferior to INDO in relieving knee pain and should be considered an alternative for the treatment of symptomatic OA of the knee. Further research into the mechanism of action of YOF3 and its long-term efficacy and safety is required.",2020,"All the interventions were well tolerated; no skin rash was observed in any of the three groups.
","['102 patients with OA of the knee', 'Patients with Symptomatic Osteoarthritis of the Knee', 'patients with OA of the knee', ' 86 completed the study: 29/34 in the YOF3 group, 25/34 in the YOF4 group, and 32/34 in the INDO group', '102 patients enrolled', 'Eligible patients']","['Yellow Oil Formulations 3 and 4 versus Indomethacin Solution', 'yellow oil formulations', 'yellow oil formulation 3 (YOF3), yellow oil formulation 4 (YOF4), or indomethacin solution (INDO']","['knee function, physical performance assessments, and safety parameters', 'tolerated; no skin rash', '100\u2009mm visual analog scale (VAS) of pain', 'efficacy and safety', 'VAS pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0221205', 'cui_str': 'Yellow color'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0221205', 'cui_str': 'Yellow color'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",102.0,0.0641835,"All the interventions were well tolerated; no skin rash was observed in any of the three groups.
","[{'ForeName': 'Nut', 'Initials': 'N', 'LastName': 'Koonrungsesomboon', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Supanimit', 'Initials': 'S', 'LastName': 'Teekachunhatean', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Sunee', 'Initials': 'S', 'LastName': 'Chansakaow', 'Affiliation': 'Department of Pharmaceutical Sciences and Medicinal Plant Innovation Center, Faculty of Pharmacy, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Nutthiya', 'Initials': 'N', 'LastName': 'Hanprasertpong', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/5782178']
1907,32774430,"Shenmayizhi Formula Combined with Ginkgo Extract Tablets for the Treatment of Vascular Dementia: A Randomized, Double-Blind, Controlled Trial.","Shenmayizhi formula (SMYZF) has been shown to have an effect on vascular dementia (VaD) in previous studies. The aim of this study was to evaluate whether a combination of SMYZF with Ginkgo extract tablets improves mild-to-moderate VaD. In this 12-week, randomized, double-blind, controlled study, we randomly assigned 196 patients with VaD (aged 50-85 years) to either the SMYZF group ( n  = 98) or the Ginkgo group ( n  = 98). All patients received Ginkgo extract tablets as a basic treatment, while the SMYZF group also received SMYZF treatment. We evaluated the participants at baseline and after 12 weeks of the intervention for the following: the Mini-Mental State Examination (MMSE), National Institutes of Health Stroke Scale (NIHSS), activities of daily living (ADL), Chinese Medicine Symptom Scale (CM-SS) scores, serum endothelin-1 (ET-1), nitric oxide (NO), vascular endothelial growth factor (VEGF), von Willebrand factor (vWF), neuron-specific enolase (NSE), brain-derived neurotrophic factor (BDNF), and homocysteine (Hcy) serum levels. Both interventions significantly increased MMSE scores and decreased NIHSS, ADL, and CM-SS scores. The SMYZF group showed greater improvement in MMSE, NIHSS, and CM-SS scores. Both groups showed a significant decrease in serum ET-1 and an increase in serum VEGF. Furthermore, serum NO increased, and vWF decreased significantly in the SMYZF group. Changes in serum ET-1 and NO were greater in the SMYZF group. Both groups showed a significant increase in serum BDNF and a decrease in serum NSE and Hcy. Improvement in serum NSE and BDNF was greater in the SMYZF group. SMYZF combined with Ginkgo extract tablets improved vascular endothelial and cognitive functions, as well as the syndromes diagnosed based on the traditional Chinese medicine in patients with VaD.",2020,"Both interventions significantly increased MMSE scores and decreased NIHSS, ADL, and CM-SS scores.","['mild-to-moderate VaD', 'Vascular Dementia', '196 patients with VaD (aged 50-85 years', 'patients with VaD']","['SMYZF combined with Ginkgo extract tablets', 'Shenmayizhi Formula Combined with Ginkgo Extract Tablets', 'Shenmayizhi formula (SMYZF', 'SMYZF', 'Ginkgo', 'Ginkgo extract tablets', 'SMYZF treatment', 'SMYZF with Ginkgo extract tablets']","['serum NO increased, and vWF', 'serum NSE and Hcy', 'vascular endothelial and cognitive functions', 'serum BDNF', 'serum NSE and BDNF', 'serum ET-1', 'Mini-Mental State Examination (MMSE), National Institutes of Health Stroke Scale (NIHSS), activities of daily living (ADL), Chinese Medicine Symptom Scale (CM-SS) scores, serum endothelin-1 (ET-1), nitric oxide (NO), vascular endothelial growth factor (VEGF), von Willebrand factor (vWF), neuron-specific enolase (NSE), brain-derived neurotrophic factor (BDNF), and homocysteine (Hcy) serum levels', 'serum VEGF', 'MMSE, NIHSS, and CM-SS scores', 'MMSE scores and decreased NIHSS, ADL, and CM-SS scores']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011269', 'cui_str': 'Vascular dementia'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0772125', 'cui_str': 'Ginkgo biloba extract'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0330205', 'cui_str': 'Ginkgo'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C1278080', 'cui_str': 'Serum homocysteine measurement'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",196.0,0.202616,"Both interventions significantly increased MMSE scores and decreased NIHSS, ADL, and CM-SS scores.","[{'ForeName': 'Huiqin', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Geriatrics, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Department of Geriatrics, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Pei', 'Affiliation': 'Department of Geriatrics, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Huichan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Geriatrics, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Geriatrics, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Geriatrics, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Diao', 'Affiliation': 'Department of Geriatrics, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Geriatrics, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Nanyang', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': 'Department of Geriatrics, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Department of Geriatrics, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Geriatrics, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/8312347']
1908,32774431,"Coloclyster of Red Peony Root Granules Alleviates Moderately Severe Acute Pancreatitis: A Double-Blinded, Placebo-Controlled, Randomized Clinical Trial.","The red peony root derived from  Paeonia lactiflora  has been applied to treat human inflammatory diseases. To investigate its therapeutic potential in treating moderately severe acute pancreatitis (MSAP), which has been rarely studied, this study was designed as a double-blinded, placebo-controlled, randomized clinical trial. A total of 60 MSAP patients were enrolled and randomly divided into an experimental ( n  = 30) group and a control group ( n  = 30), who received a coloclyster of 15 g of red peony root or placebo granules dissolved in 150 mL of water, respectively. The patients' demographic and clinical characteristics were recorded. The results showed that the experimental group had a shorter remission time of fever ( p  < 0.05) and abdominal pain ( p  < 0.01) and faster resumption of self-defecation ( p  < 0.01) than did the control group. In addition, the coloclyster of red peony root decreased the modified Balthazar CT score as well as the serum interleukin-6 and tumor necrosis factor-alpha levels to a greater extent than did the placebo coloclyster ( p  < 0.05). The remission times for the normalization of white blood cells and percentage of neutrophils and lymphocytes in the experimental group were also significantly shorter than those in the control group ( p  < 0.05). In conclusion, a coloclyster of red peony root could help alleviate the clinical symptoms and shorten the course of MSAP by possibly attenuating systematic inflammation. This trial is registered with 14004664.",2020,The results showed that the experimental group had a shorter remission time of fever ( p  < 0.05) and abdominal pain ( p  < 0.01) and faster resumption of self-defecation ( p  < 0.01) than did the control group.,"['moderately severe acute pancreatitis (MSAP', 'Moderately Severe Acute Pancreatitis', '60 MSAP patients']","['Red Peony Root Granules Alleviates', 'Placebo', 'control group ( n \u2009=\u200930), who received a coloclyster of 15\u2009g of red peony root or placebo granules dissolved', 'placebo']","['serum interleukin-6 and tumor necrosis factor-alpha levels', 'faster resumption of self-defecation', 'modified Balthazar CT score', 'normalization of white blood cells and percentage of neutrophils and lymphocytes', 'shorter remission time of fever', 'abdominal pain']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0969726', 'cui_str': 'Peony'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1549535', 'cui_str': 'Dissolve'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}]",60.0,0.219181,The results showed that the experimental group had a shorter remission time of fever ( p  < 0.05) and abdominal pain ( p  < 0.01) and faster resumption of self-defecation ( p  < 0.01) than did the control group.,"[{'ForeName': 'Fangyong', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Department of Traditional Chinese Medicine, Changhai Hospital, Naval Medical University, No. 168 Changhai Road, Shanghai 200433, China.'}, {'ForeName': 'Xiuzhong', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': 'Department of Traditional Chinese Medicine, Qingdao Special Service Sanatorium of PLA Navy, No. 27 Xianggang West Road, Qingdao 266071, China.'}, {'ForeName': 'Yiqi', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Naval Medical University, No. 168 Changhai Road, Shanghai 200433, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Naval Medical University, No. 168 Changhai Road, Shanghai 200433, China.'}, {'ForeName': 'Meitang', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Emergency, Changhai Hospital, Naval Medical University, No. 168 Changhai Road, Shanghai 200433, China.'}, {'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': ""Department of Critical Care Medicine, Laixi People's Hospital, No. 69 Yantai Road, Laixi, 266600, China.""}, {'ForeName': 'Dezeng', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': 'Department of Traditional Chinese Medicine, Changhai Hospital, Naval Medical University, No. 168 Changhai Road, Shanghai 200433, China.'}, {'ForeName': 'Xiaoqiang', 'Initials': 'X', 'LastName': 'Yue', 'Affiliation': 'Department of Traditional Chinese Medicine, Changzheng Hospital, Naval Medical University, No. 415 Fengyang Road, Shanghai 200003, China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Traditional Chinese Medicine, Changhai Hospital, Naval Medical University, No. 168 Changhai Road, Shanghai 200433, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/8401239']
1909,32774437,Effects of resistance training on serum 25(OH) D concentrations in young men: a randomized controlled trial.,"Background


Previous studies indicated that serum 25-hydroxyvitamin D [25(OH)D] concentrations are positively associated with physical activity levels independent of sun exposure. However, the effect of resistance training on serum 25(OH) D concentrations remains unclear. Thus, this study aimed to examine the effect of chronic resistance training on serum 25(OH) D concentrations and determine whether 25(OH) D concentration variations are influenced by body composition changes.
Methods


Eighteen young men aged 19-39 years were randomly divided into a 12-week resistance training group (RT,  n  = 9) and non-exercise control group (CON,  n  = 9). The trial was undertaken in Shanghai University of Sport in Shanghai, China. Randomization and allocation to trial group were carried out by a central computer system. Serum 25(OH) D and intact parathyroid hormone concentrations were measured using commercially available enzyme-linked immunosorbent assay kits. Body composition was measured by dual-energy X-ray absorptiometry.
Results


The average serum 25(OH) D concentrations were 26.6 nmol/L at baseline. After the 12-week intervention program, serum 25(OH) D concentrations significantly increased in both groups. Serum 25(OH) D concentrations at midpoint (6-week) increased significantly only in the CON group ( P  < 0.01). From training midpoint to endpoint, a significantly greater increase in serum 25(OH) D concentrations was noted in the RT group (P-interaction = 0.043); 25(OH) D concentration changes (end-pre) were negatively related to fat-free mass (mid-pre) ( r  = - 0.565,  P  = 0.015) and muscle mass (mid-pre) ( r  = - 0.554,  P  = 0.017).
Conclusions


There were no beneficial effects of the 12-week resistance training on serum 25(OH) D concentration in vitamin D deficient young men, and an indication that seasonal increase in serum 25(OH) D concentrations during the early phase of resistance training was transiently inhibited, which may partly be attributed to resistance training-induced muscle mass gain.
Trial registration


Chinese Clinical Trial Registry, ChiCTR2000030876. Registered 16 March 2020 - Retrospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=50504.",2020,D concentrations at midpoint (6-week) increased significantly only in the CON group ( P  < 0.01).,"['vitamin D deficient young men', 'Shanghai University of Sport in Shanghai, China', 'young men', 'Eighteen young men aged 19-39\u2009years']","['chronic resistance training', '25(OH', 'resistance training group (RT,  n \u2009=\u20099) and non-exercise control group (CON,  n \u2009=\u20099', 'resistance training', 'CON']","['D and intact parathyroid hormone concentrations', 'Body composition', 'Serum 25(OH', 'muscle mass', 'average serum 25(OH', 'serum 25-hydroxyvitamin D [25(OH)D] concentrations', 'D concentrations', 'serum 25(OH']","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}]",18.0,0.0234992,D concentrations at midpoint (6-week) increased significantly only in the CON group ( P  < 0.01).,"[{'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Global Health Institute, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, 710061 China.""}, {'ForeName': 'Xiao-Kai', 'Initials': 'XK', 'LastName': 'Ma', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, 399 Chang Hai Road, Shanghai, 200438 China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, 399 Chang Hai Road, Shanghai, 200438 China.'}, {'ForeName': 'Zhen-Bo', 'Initials': 'ZB', 'LastName': 'Cao', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, 399 Chang Hai Road, Shanghai, 200438 China.'}]",Nutrition & metabolism,['10.1186/s12986-020-00480-w']
1910,32774508,Chloroquine and COVID-19: Should We Care about Ototoxicity?,"Introduction   Severe acute respiratory syndrome coronavirus 2 was first described in December 2019 in China leading to a Public Health Emergency of International Concern. It was named by the World Health Organization as Coronavirus Disease 2019 (COVID-19), and it garnered unprecedented attention from public health researchers around the world, and studies analyzing chloroquine and hydroxychloroquine as a possible therapy have arisen in the last 2 months.  Objective   To review the literature and describe updated facts about the ototoxicity of chloroquine and hydroxychloroquine, an important side effect that can be present in patients with COVID-19 treated with these drugs.  Data Synthesis   The most typical treatment regimen is 5 days of hydroxychloroquine at daily doses of 400 to 600 mg. There is no randomized clinical trial that can prove so far the efficacy of this medication, and few studies have evaluated adverse events potentially linked to their use in patients with COVID-19. While there is no concrete evidence on the incidence of ototoxicity using chloroquine in the short term, we need to consider that, as a pandemic disease, millions of patients with COVID-19 may receive this treatment, and ototoxicity can be a possible adverse event.  Conclusion   Despite the urgent global situation caused by the COVID-19, the risk of irreversible hearing loss may outweigh the unproven benefit of using hydroxychloroquine or chloroquine, especially in patients with mild forms of COVID-19, who may be cured with supportive treatment. The potential hearing loss that can be caused by these medications may advise against their use in COVID-19 patients.",2020,The potential hearing loss that can be caused by these medications may advise against their use in COVID-19 patients.,"['patients with COVID-19', 'patients with mild forms of COVID-19, who may be cured with supportive treatment', 'Introduction  \u2003Severe acute respiratory syndrome coronavirus 2 was first described in December 2019 in China leading to a Public Health Emergency of International Concern', 'patients with COVID-19 treated with these drugs']","['Chloroquine and COVID-19', 'hydroxychloroquine or chloroquine', 'hydroxychloroquine', 'chloroquine', 'chloroquine and hydroxychloroquine']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]",[],,0.0582394,The potential hearing loss that can be caused by these medications may advise against their use in COVID-19 patients.,"[{'ForeName': 'Eduardo Machado Rossi', 'Initials': 'EMR', 'LastName': 'Monteiro', 'Affiliation': 'Department of Otorhinolaryngology, Hospital Felício Rocho, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Maria Fernanda Lima', 'Initials': 'MFL', 'LastName': 'Nascimento', 'Affiliation': 'Department of Otorhinolaryngology, Hospital Felício Rocho, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Thayanne Rachel Cangussu', 'Initials': 'TRC', 'LastName': 'Brito', 'Affiliation': 'Department of Otorhinolaryngology, Hospital Felício Rocho, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Marcos Correia', 'Initials': 'MC', 'LastName': 'Lima', 'Affiliation': 'Department of Otorhinolaryngology, Hospital Felício Rocho, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Laura Rodrigues', 'Initials': 'LR', 'LastName': 'Sefair', 'Affiliation': 'Department of Otorhinolaryngology, Hospital Felício Rocho, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Maisa Mendes', 'Initials': 'MM', 'LastName': 'Pedrosa', 'Affiliation': 'Department of Otorhinolaryngology, Hospital Felício Rocho, Belo Horizonte, MG, Brazil.'}]",International archives of otorhinolaryngology,['10.1055/s-0040-1714142']
1911,32774542,Can Heart Rate Variability Biofeedback Improve Athletic Performance? A Systematic Review.,"This systematic review was conducted to evaluate the effect of heart rate variability biofeedback (HRV BFB) on performance of athletes. Six electronic databases (Springerlink, SportDiscus, Web of Science, PROQUEST Academic Research Library, Google Scholar, and ScienceDirect) and article references were searched. Eligibility criteria were: 1. experimental studies involving athletes randomly allocated among groups (randomized control trial); 2. availability of HRV BFB as a treatment compared to a control condition (CON) that involves regular sport/dance training, a placebo (PLA) or other methods of BFB; 3. performance-related variables such as a dependent index; and, 4. peer-reviewed articles written in English. Out of 660 articles, six studies were included in the systematic review which involved 187 athletes (females: n = 89; males n = 98). Six studies compared HRV BFB with a CON, three studies compared HRV BFB with a PLA, and two studies differentiated HRV BFB with other methods of BFB. Findings support HRV BFB as a potential intervention to improve fine and gross motor function in athletes.",2020,This systematic review was conducted to evaluate the effect of heart rate variability biofeedback (HRV BFB) on performance of athletes.,"['athletes', 'Out of 660 articles, six studies were included in the systematic review which involved 187 athletes (females: n = 89; males n = 98']","['HRV BFB', 'control condition (CON) that involves regular sport/dance training, a placebo (PLA', 'heart rate variability biofeedback (HRV BFB']",[],"[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1955832', 'cui_str': 'Review, Systematic'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],187.0,0.0902463,This systematic review was conducted to evaluate the effect of heart rate variability biofeedback (HRV BFB) on performance of athletes.,"[{'ForeName': 'Jeffrey Cayaban', 'Initials': 'JC', 'LastName': 'Pagaduan', 'Affiliation': 'College of Health and Medicine, School of Health Sciences, University of Tasmania, Launceston, Tasmania, Australia.'}, {'ForeName': 'Yung-Sheng', 'Initials': 'YS', 'LastName': 'Chen', 'Affiliation': 'Department of Exercise and Health Sciences, University of Taipei, Taipei, Taiwan.'}, {'ForeName': 'James William', 'Initials': 'JW', 'LastName': 'Fell', 'Affiliation': 'College of Health and Medicine, School of Health Sciences, University of Tasmania, Launceston, Tasmania, Australia.'}, {'ForeName': 'Sam Shi Xuan', 'Initials': 'SSX', 'LastName': 'Wu', 'Affiliation': 'Faculty of Health, Arts, and Design, School of Health Sciences, Department of Health and Medical Sciences, Swinburne University, Melbourne, Australia.'}]",Journal of human kinetics,['10.2478/hukin-2020-0004']
1912,32774544,Acute Hormonal Responses to High-Intensity Interval Training in Hyperoxia.,"This study aimed to compare selected hormonal responses to a single session of high intensity interval training performed with an increased fraction of inspired oxygen (hyperoxia) and under normoxic conditions. Twelve recreationally trained men (age 24 ± 3 years) performed two sessions of high intensity interval training on a cycle ergometer, in randomized order with hyperoxia (4 L·min -1  with a flowrate of 94% O 2 ) and normoxia. Each session consisted of 5 intervals of 3 minutes at 85% of the maximal power output, interspersed by 2 min at 40% of the maximal power output. Serum cortisol, prolactin and vascular endothelial growth factor (VEGF) were assessed both before and immediately after each high intensity interval training session. Statistically significant differences in cortisol were found between hyperoxic and normoxic conditions (p = 0.011), with a significant increase in hyperoxia (61.4 ± 73.2%, p = 0.013, ES = -1.03), but not in normoxia (-1.3 ± 33.5%, p > 0.05, ES = 0.1). Prolactin increased similarly in both hyperoxia (118.1 ± 145.1%, p = 0.019, ES = -0.99) and normoxia (62.14 ± 75.43%, p = 0.005, ES = -0.5). VEGF was not statistically altered in either of the conditions. Our findings indicate that a single session of high intensity interval training in low-dose hyperoxia significantly increased cortisol concentrations in recreationally trained individuals compared to normoxia, while the difference was smaller in prolactin and diminished in VEGF concentrations.",2020,"Prolactin increased similarly in both hyperoxia (118.1 ± 145.1%, p = 0.019, ES = -0.99) and normoxia (62.14 ± 75.43%, p = 0.005, ES = -0.5).",['Twelve recreationally trained men (age 24 ± 3 years'],"['high intensity interval training on a cycle ergometer, in randomized order with hyperoxia (4 L·min -1  with a flowrate of 94% O 2 ) and normoxia']","['fraction of inspired oxygen (hyperoxia', 'VEGF concentrations', 'Serum cortisol, prolactin and vascular endothelial growth factor (VEGF', 'cortisol', 'Prolactin', 'cortisol concentrations', 'VEGF', 'hyperoxia']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0242706', 'cui_str': 'Hyperoxia'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0242706', 'cui_str': 'Hyperoxia'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]",12.0,0.076447,"Prolactin increased similarly in both hyperoxia (118.1 ± 145.1%, p = 0.019, ES = -0.99) and normoxia (62.14 ± 75.43%, p = 0.005, ES = -0.5).","[{'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Manferdelli', 'Affiliation': 'Institute of Cardiovascular Research and Sport Medicine, Department of Molecular and Cellular Sport Medicine, German Sport University, Cologne, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Freitag', 'Affiliation': 'Institute of Cardiovascular Research and Sport Medicine, Department of Molecular and Cellular Sport Medicine, German Sport University, Cologne, Germany.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Doma', 'Affiliation': 'Sport and Exercise Science, James Cook University, Townsville, QLD, Australia.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Hackney', 'Affiliation': 'Department of Exercise & Sport Science, University of North Carolina, Chapel Hill, USA.'}, {'ForeName': 'Hans-Georg', 'Initials': 'HG', 'LastName': 'Predel', 'Affiliation': 'Institute of Cardiovascular Research and Sport Medicine, Department of Preventive and Rehabilitative Sport Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Bloch', 'Affiliation': 'Institute of Cardiovascular Research and Sport Medicine, Department of Molecular and Cellular Sport Medicine, German Sport University, Cologne, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Schumann', 'Affiliation': 'Institute of Cardiovascular Research and Sport Medicine, Department of Molecular and Cellular Sport Medicine, German Sport University, Cologne, Germany.'}]",Journal of human kinetics,['10.2478/hukin-2019-0137']
1913,32774545,Does Photobiomodulation Therapy Enhance Maximal Muscle Strength and Muscle Recovery?,"Photobiomodulation has been shown to improve tissue and cell functions. We evaluated the influence of photobiomodulation, using a B-Cure laser, on: 1) maximal performance, and 2) muscle recovery after resistance exercise. Two separate crossover randomized double-blinded placebo-controlled trials were conducted. Sixty healthy physical education students (28 men, 32 women), aged 20-35, were recruited (30 participants for each trial). Participants performed two interventions for each experiment, with real lasers (GaAlAs, 808 nm) on three quadricep locations in parallel (overall treatment energy of ~150J) or sham (placebo) treatment. In the first experiment muscle total work (TW) and peak torque (PT) were measured by an isokinetic dynamometer in five repetitions of knee extension, and in the second experiment muscle recovery was measured after the induction of muscle fatigue by evaluating TW and PT in five repetitions of knee extension. There were no differences between treatments (real or sham) regarding the TW (F(1,28) = 1.09, p = .31), or PT (F(1,29) = .056, p = .814). In addition, there was no effect of photobiomodulation on muscle recovery as measured by the TW (F(1,27) = .16, p = .69) or PT (F(1,29) = .056, p = .814). Applying photobiomodulation for 10 min immediately before exercise did not improve muscle function or muscle recovery after fatigue.",2020,"There were no differences between treatments (real or sham) regarding the TW (F(1,28) = 1.09, p = .31), or PT (F(1,29) = .056, p = .814).","['Sixty healthy physical education students (28 men, 32 women), aged 20-35, were recruited (30 participants for each trial']","['real lasers (GaAlAs, 808 nm) on three quadricep locations in parallel (overall treatment energy of ~150J) or sham (placebo', 'placebo']","['muscle recovery', 'muscle function or muscle recovery', 'muscle total work (TW) and peak torque (PT']","[{'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}]",60.0,0.101864,"There were no differences between treatments (real or sham) regarding the TW (F(1,28) = 1.09, p = .31), or PT (F(1,29) = .056, p = .814).","[{'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Tsuk', 'Affiliation': 'The Academic College at Wingate, Netanya, Israel.'}, {'ForeName': 'Yarden Har', 'Initials': 'YH', 'LastName': 'Lev', 'Affiliation': 'The Academic College at Wingate, Netanya, Israel.'}, {'ForeName': 'Orly', 'Initials': 'O', 'LastName': 'Fox', 'Affiliation': 'The Academic College at Wingate, Netanya, Israel.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Carasso', 'Affiliation': 'The Hillel Yaffe Medical Center, Hadera, Israel.'}, {'ForeName': 'Ayelet', 'Initials': 'A', 'LastName': 'Dunsky', 'Affiliation': 'The Academic College at Wingate, Netanya, Israel.'}]",Journal of human kinetics,['10.2478/hukin-2019-0138']
1914,32774546,A Comparison Between the Squat and the Deadlift for Lower Body Strength and Power Training.,"The aim of this study was to compare the effects of two resistance training programs including either a deadlift or a parallel squat on lower body maximal strength and power in resistance trained males. Twenty-five resistance trained men were randomly assigned to a deadlift group (DE; n = 14; age = 24.3 ± 4.1 y; body mass = 84.8 ± 14.2 kg; body height = 180.3 ± 6.8 cm) or to a squat group (SQ; n = 11; age = 22.3 ± 1.6 y; body mass = 83.0 ± 13.6 kg; body height 179.9 ± 6.1 cm). Both groups trained 3 times per week for 6 weeks. The deadlift and the squat were the only lower body maximal strength exercises performed by DE and SQ groups, respectively, while both training programs included jumps. A significantly (p = 0.017) greater increase in deadlift 1RM was observed in the DE compared to the SQ group, while the SQ group obtained a significantly (p = 0.049) greater increase in squat 1RM. A significant increase in jump performance (p = 0.010), without significant interactions between groups (p = 0.552), was observed in both groups. Three participants of the DE group developed lower back pain and were excluded from the study. Results indicate that both the squat and the deadlift can result in similar improvement in lower body maximal strength and jump performance and can be successfully included in strength training programs. The incidence of back pain in the DE group may suggest a marked stress of this exercise on the lower back. Proper technique should be used to minimize the risk of injury, especially when the deadlift is performed.",2020,"The deadlift and the squat were the only lower body maximal strength exercises performed by DE and SQ groups, respectively, while both training programs included jumps.","['resistance trained males', 'Twenty-five resistance trained men were randomly assigned to a deadlift group (DE; n = 14; age = 24.3 ± 4.1 y; body mass = 84.8 ± 14.2 kg; body height = 180.3 ± 6.8 cm) or to a squat group (SQ; n = 11; age = 22.3 ± 1.6 y; body mass = 83.0 ± 13.6 kg; body height 179.9 ± 6.1 cm']",['resistance training programs'],"['jump performance', 'lower back pain', 'deadlift 1RM', 'back pain', 'squat 1RM', 'lower body maximal strength and jump performance']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C4517560', 'cui_str': '13.6'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]",25.0,0.0218823,"The deadlift and the squat were the only lower body maximal strength exercises performed by DE and SQ groups, respectively, while both training programs included jumps.","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Nigro', 'Affiliation': 'Department for Life Quality Studies, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Bartolomei', 'Affiliation': 'Department for Life Quality Studies, University of Bologna, Bologna, Italy.'}]",Journal of human kinetics,['10.2478/hukin-2019-0139']
1915,32766042,Effect of Platelet Rich Plasma versus Saline Solution as a Preservation Solution for Hair Transplantation.,"Background


Hair transplantation is the only method available to regrow new hairs; hence, enhancing the results of this procedure using state-of-the-art methods has become mandatory in clinical practice. Recent studies have suggested that significant improvements in hair density and stimulation of hair growth occur when follicular units are pretreated with platelet plasma growth factors before implantation. This study aimed to investigate and compare the outcomes of this procedure using platelet-rich plasma (PRP)-preserved hair grafts and saline-preserved hair grafts.
Methods


This is a randomized controlled study. The study included 27 men and 3 women aged 22-51 years. Clinical examination (general and local) and preoperative marking were performed in these patients. The surgical technique involved graft extraction, PRP preparation, and hair implantation. Postsurgical patient satisfaction and clinical improvement were evaluated.
Results


There were significant differences between the groups in hair uptake and hair thickness after 1 year follow-up, with  P  value <0.05. Using PRP therapy with follicular unit extraction increases the success of follicular unit extraction hair transplantation. All participants in the PRP group had >75% hair regrowth after 6 months. They had more rapid improvements in hair density and skin recovery than those in the non-PRP group.
Conclusion


Preserving hair grafts in PRP before implantation increases the hair density, the graft uptake, and the hair thickness compared with pretreatment preservation of hair grafts in saline.",2020,"There were significant differences between the groups in hair uptake and hair thickness after 1 year follow-up, with  P  value <0.05.","['Hair Transplantation', '27 men and 3 women aged 22-51 years']","['PRP therapy with follicular unit extraction', 'Platelet Rich Plasma versus Saline Solution', 'platelet-rich plasma (PRP)-preserved hair grafts and saline-preserved hair grafts']","['hair density, the graft uptake, and the hair thickness', 'hair density and stimulation of hair growth', 'hair density and skin recovery', 'Postsurgical patient satisfaction and clinical improvement', 'hair regrowth', 'hair uptake and hair thickness']","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4727879', 'cui_str': 'Platelet rich plasma therapy'}, {'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0232407', 'cui_str': 'Hair growth'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",27.0,0.090237,"There were significant differences between the groups in hair uptake and hair thickness after 1 year follow-up, with  P  value <0.05.","[{'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'Abdelkader', 'Affiliation': 'Department of Plastic Surgery, Alkasr Allni Hospital, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Abdalbary', 'Affiliation': 'Orthopaedic Physical Therapy Department, Alkasr Alainy Hospital, Cairo University, Cairo, Egpyt.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Naguib', 'Affiliation': 'Department of Plastic Surgery, Alkasr Allni Hospital, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Kyrillos', 'Initials': 'K', 'LastName': 'Makarem', 'Affiliation': 'Department of Plastic Surgery, Alkasr Allni Hospital, Cairo University, Cairo, Egypt.'}]",Plastic and reconstructive surgery. Global open,['10.1097/GOX.0000000000002875']
1916,32766062,Treatment of Post-mastectomy Lymphedema with Herbal Medicine: An Innovative Pilot Study.,"Background


Lymphedema of the arms or legs is a difficult clinical problem yet devoid of effective treatment. Lymphedema is the result of obstructed lymphatic flow secondary to chronic infection, parasitic infestation, or postsurgical obstruction (eg, after axillary dissections). We arranged this clinical trial to investigate whether patients with limb lymphedema can benefit from a standard dose of  Astragalus  plus  Paeoniae rubra  to improve the symptomatology, functional capacity, and quality of life (QOL).
Method


The pilot study was designed as a self-control clinical trial. Patients with post-mastectomy lymphedema were recruited. A double-herb formulation ( Astragalus, Paeoniae rubra ) with standard dosage was administered orally in a powdered form, 6 times per week for 6 months. Outcome measurements included standard limb volume changes measured by water displacement method; handgrip strength; and QOL for limb lymphedema questionnaire (LYMQOL).
Results


There were no reported adverse effects or complications; there were no episodes of infection during the period of study. There was a tendency of limb volume reduction by 6 months, which, however, did not reach statistical significance. There was a significant improvement in appearance and symptom scores as was assessed with the LYMQOL questionnaire.
Conclusions


The oral herbal formula improved the symptomatology and QOL among the pilot group of patients with post-mastectomy lymphedema. Side effects were absent, and there was a trend of lymphedema reduction.",2020,There were no reported adverse effects or complications; there were no episodes of infection during the period of study.,"['patients with limb lymphedema', 'Patients with post-mastectomy lymphedema']",['Post-mastectomy Lymphedema with Herbal Medicine'],"['lymphedema reduction', 'symptomatology and QOL', 'limb volume reduction', 'LYMQOL questionnaire', 'appearance and symptom scores', 'Side effects', 'symptomatology, functional capacity, and quality of life (QOL', 'adverse effects or complications', 'standard limb volume changes measured by water displacement method; handgrip strength; and QOL for limb lymphedema questionnaire (LYMQOL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0032775', 'cui_str': 'Post-mastectomy Lymphedema'}]","[{'cui': 'C0032775', 'cui_str': 'Post-mastectomy Lymphedema'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}]","[{'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",,0.0374642,There were no reported adverse effects or complications; there were no episodes of infection during the period of study.,"[{'ForeName': 'Tor-Wo', 'Initials': 'TW', 'LastName': 'Chiu', 'Affiliation': 'Plastic, Reconstructive and Aesthetic Surgery, Burns Service, Prince of Wales Hospital, Shatin, Hong Kong.'}, {'ForeName': 'Shun-Ling', 'Initials': 'SL', 'LastName': 'Kong', 'Affiliation': 'Centre for Clinical Trials on Chinese Medicine, Institute of Chinese Medicine, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'King-Fai', 'Initials': 'KF', 'LastName': 'Cheng', 'Affiliation': 'Centre for Clinical Trials on Chinese Medicine, Institute of Chinese Medicine, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ping-Chung', 'Initials': 'PC', 'LastName': 'Leung', 'Affiliation': 'Centre for Clinical Trials on Chinese Medicine, Institute of Chinese Medicine, The Chinese University of Hong Kong, Hong Kong.'}]",Plastic and reconstructive surgery. Global open,['10.1097/GOX.0000000000002915']
1917,32766181,Paracetamol vs. Ibuprofen in Preterm Infants With Hemodynamically Significant Patent Ductus Arteriosus: A Non-inferiority Randomized Clinical Trial Protocol.,"Background:  Currently, the first line treatment of persistent ductus arteriosus (PDA) is either indomethacin or ibuprofen. However, the potentially life-threatening side effects associated to their use have prompted physicians to look for alternative options. The incorporation of paracetamol as an alternative to ibuprofen in the management of PDA is still based on insufficient clinical evidence. Hence, more clinical trials are needed to establish a therapeutic role for paracetamol in the management of PDA that take into consideration short- and long-term safety and efficacy outcomes.  Study Design:  This is a non-inferiority, randomized, multicenter, double-blinded study to evaluate the efficacy, and safety of intravenous (IV) paracetamol vs. IV ibuprofen (standard treatment) for PDA in preterm patients with a gestational age ≤ 30 weeks. At baseline, patients will be randomized (1:1) to treatment with paracetamol or ibuprofen. The primary endpoint is closure of the ductus after the first treatment course. Secondary endpoints are related to effectiveness (need for a second treatment course, rescue treatment, reopening rate, time to definitive closure, need for surgical ligation), safety (early and long-term complications), pharmacokinetics, and pharmacodynamics, pharmacogenetics, pharmacoeconomics, and genotoxicity. Long-term follow-up to 24 months of corrected postnatal age will be performed using Bayley III neurodevelopmental scale.  Trial Registration:  ClinicalTrials.gov Identifier: NCT04037514. EudraCT: 2015-003177-14.",2020,"Secondary endpoints are related to effectiveness (need for a second treatment course, rescue treatment, reopening rate, time to definitive closure, need for surgical ligation), safety (early and long-term complications), pharmacokinetics, and pharmacodynamics, pharmacogenetics, pharmacoeconomics, and genotoxicity.","['preterm patients with a gestational age ≤ 30 weeks', 'Arteriosus', 'persistent ductus arteriosus (PDA', 'Preterm Infants With Hemodynamically Significant Patent Ductus']","['indomethacin or ibuprofen', 'Paracetamol vs. Ibuprofen', 'intravenous (IV) paracetamol vs. IV ibuprofen', 'paracetamol', 'EudraCT', 'ibuprofen', 'paracetamol or ibuprofen']","['effectiveness (need for a second treatment course, rescue treatment, reopening rate, time to definitive closure, need for surgical ligation), safety (early and long-term complications), pharmacokinetics, and pharmacodynamics, pharmacogenetics, pharmacoeconomics, and genotoxicity', 'closure of the ductus']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0030650', 'cui_str': 'Patents'}]","[{'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031325', 'cui_str': 'Pharmacogenetics'}, {'cui': 'C0206335', 'cui_str': 'Pharmaceutical Economics'}, {'cui': 'C0598309', 'cui_str': 'Genotoxicity'}]",,0.123765,"Secondary endpoints are related to effectiveness (need for a second treatment course, rescue treatment, reopening rate, time to definitive closure, need for surgical ligation), safety (early and long-term complications), pharmacokinetics, and pharmacodynamics, pharmacogenetics, pharmacoeconomics, and genotoxicity.","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'García-Robles', 'Affiliation': 'Neonatal Research Group, Health Research Institute La Fe, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Gimeno Navarro', 'Affiliation': 'Neonatal Research Group, Health Research Institute La Fe, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'María Del Mar', 'Initials': 'MDM', 'LastName': 'Serrano Martín', 'Affiliation': 'Division of Neonatology, Regional University Hospital of Malaga, Málaga, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Párraga Quiles', 'Affiliation': 'Division of Neonatology, University Hospital Reina Sofía, Córdoba, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Parra Llorca', 'Affiliation': 'Neonatal Research Group, Health Research Institute La Fe, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Poveda-Andrés', 'Affiliation': 'Division of Pharmacy, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Máximo', 'Initials': 'M', 'LastName': 'Vento Torres', 'Affiliation': 'Neonatal Research Group, Health Research Institute La Fe, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Aguar Carrascosa', 'Affiliation': 'Neonatal Research Group, Health Research Institute La Fe, University and Polytechnic Hospital La Fe, Valencia, Spain.'}]",Frontiers in pediatrics,['10.3389/fped.2020.00372']
1918,32766199,Effects of Female Community Health Volunteer Capacity Building and Text Messaging Intervention on Gestational Weight Gain and Hemoglobin Change Among Pregnant Women in Southern Nepal: A Cluster Randomized Controlled Trial.,"Introduction:  Public health interventions such as text messaging are commonly evaluated in high-income countries and that the evaluation reports of the effectiveness of community health volunteers in low-income countries like Nepal is scarce. This study aimed to determine whether female community health volunteer (FCHV) capacity building and text messaging to expectant mother increases gestational weights and hemoglobin levels of pregnant women living in southern Nepal.  Methods:  A cluster randomized control trial was carried out in 52 clusters of 6 Village Development Committees in southern Nepal between July 2015 and March 2016. A total of 413 pregnant mothers of gestation age between 13 and 28 weeks (214 in the intervention group and 199 in the control group) were included in the analysis. Intervention consisted of FCHV capacity building followed by regular supervision and monitoring and mobile phone text messaging to expectant mothers. Regression analysis, controlled for confounders, was conducted to assess gestational weight gains and changes in hemoglobin levels.  Results:  At the end of the pregnancy, the mean weight gain difference between the intervention and control groups was 1.1 kg (95% CI: 1.0, 1.9). Rates of weight increases in the intervention and control groups were 0.504 kg/week (95% CI: 0.371, 0.528), and 0.399 kg/week (95% CI: 0.362, 0.465), respectively. Similarly, the mean inter group difference in hemoglobin levels was 0.11 gm/dl (95% CI: 0.09, 0.15), and rates of hemoglobin increases (gm/dl/week) in the intervention and control groups were 0.02 gm/dl (95% CI: 0.01, 0.09) and 0.004 gm/dl (95% CI: 0.02, 0.12), respectively.  Conclusions:  The study shows that FCHV capacity building and mobile text messaging have a positive effect on the gestational weights and hemoglobin levels of expectant mothers. Our findings suggest that mobile text messaging coupled with FCHV capacity building services should be supported and would usefully expand in resource poor settings.  Trial registration:  ISRCTN60684155.",2020,The study shows that FCHV capacity building and mobile text messaging have a positive effect on the gestational weights and hemoglobin levels of expectant mothers.,"['expectant mothers', '413 pregnant mothers of gestation age between 13 and 28 weeks (214 in the intervention group and 199 in the control group) were included in the analysis', 'female community health volunteer (FCHV', 'pregnant women living in southern Nepal', '52 clusters of 6 Village Development Committees in southern Nepal between July 2015 and March 2016', 'Pregnant Women in Southern Nepal']","['Female Community Health Volunteer Capacity Building and Text Messaging Intervention', 'FCHV capacity building followed by regular supervision and monitoring and mobile phone text messaging to expectant mothers']","['mean weight gain difference', 'gestational weights and hemoglobin levels', 'Gestational Weight Gain and Hemoglobin Change', 'gestational weight gains and changes in hemoglobin levels', 'rates of hemoglobin increases', 'hemoglobin levels', 'Rates of weight increases']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C2718026', 'cui_str': 'Capacity Building'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0549448', 'cui_str': 'Increased hemoglobin'}]",413.0,0.240995,The study shows that FCHV capacity building and mobile text messaging have a positive effect on the gestational weights and hemoglobin levels of expectant mothers.,"[{'ForeName': 'Jitendra Kumar', 'Initials': 'JK', 'LastName': 'Singh', 'Affiliation': 'Department of Community Medicine, Janaki Medical College, Tribhuvan University, Janakpur, Nepal.'}, {'ForeName': 'Dilaram', 'Initials': 'D', 'LastName': 'Acharya', 'Affiliation': 'Department of Preventive Medicine, College of Medicine, Dongguk University, Gyeongju-si, South Korea.'}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Paudel', 'Affiliation': 'Central Department of Public Health, Institute of Medicine, Tribhuvan University, Kathmandu, Nepal.'}, {'ForeName': 'Salila', 'Initials': 'S', 'LastName': 'Gautam', 'Affiliation': 'Department of Public Health, Sanjeevani College of Medical Sciences, Biratnagar, Nepal.'}, {'ForeName': 'Mandira', 'Initials': 'M', 'LastName': 'Adhikari', 'Affiliation': 'Nepal Development Society, Bharatpur, Nepal.'}, {'ForeName': 'Shambhu Prasad', 'Initials': 'SP', 'LastName': 'Kushwaha', 'Affiliation': 'District Health Office, Janakpur, Nepal.'}, {'ForeName': 'Ji-Hyuk', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Preventive Medicine, College of Medicine, Dongguk University, Gyeongju-si, South Korea.'}, {'ForeName': 'Seok-Ju', 'Initials': 'SJ', 'LastName': 'Yoo', 'Affiliation': 'Department of Preventive Medicine, College of Medicine, Dongguk University, Gyeongju-si, South Korea.'}, {'ForeName': 'Kwan', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Department of Preventive Medicine, College of Medicine, Dongguk University, Gyeongju-si, South Korea.'}]",Frontiers in public health,['10.3389/fpubh.2020.00312']
1919,32766259,The Role of Vitamin D in Combination Treatment for Patients With Rheumatoid Arthritis.,"Background:  The aim of this study is to evaluate the clinical efficacy of vitamin D (VitD) supplementation in terms of response to treatment and improvement of disease activity in rheumatoid arthritis (RA).  Methods:  This study analyzed 1180 RA patients' records treated at Mianyang Central Hospital from February 2015 to July 2019. The patients were allocated into VitD group and control group based on their medical regimens. The outcome measures were primary efficacy, defined as treatment response-based EULAR response criteria in RA, and secondary efficacy, defined as improvement in disease activity indicators. Safety was evaluated according to the incidence of all-cause infections.  Results:  At month 6, the primary efficacy revealed that there were 22.8% good responders and 19.0% moderate responders in the VitD group, and 22.3% good responders and 22.3% moderate responders in the control group; there were no differences between the two groups ( p  = 0.754). The similar primary efficacy outcomes were observed at months 3, 12, and >12. The secondary efficacy indicated that there were no differences in most indexes between the two groups at months 1, 3, 6, 12, and >12. The subgroups (based on baseline DAS28 (CRP), glucocorticoids use and disease duration) analysis results suggested that VitD group didn't have the advantage for treating RA. The incidence of infections was similar in the two groups.  Conclusion:  VitD supplementation did not provide additional benefit for anti-rheumatic treatment. These data supported the need for prospective, randomized, controlled trials to evaluate the role of VitD supplementation in treating RA.",2020,"The secondary efficacy indicated that there were no differences in most indexes between the two groups at months 1, 3, 6, 12, and >12.","[""1180 RA patients' records treated at Mianyang Central Hospital from February 2015 to July 2019"", 'rheumatoid arthritis (RA', 'Patients With Rheumatoid Arthritis']","['vitamin D (VitD) supplementation', 'Vitamin D']","['incidence of infections', 'treatment response-based EULAR response criteria in RA, and secondary efficacy, defined as improvement in disease activity indicators']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",1180.0,0.0228291,"The secondary efficacy indicated that there were no differences in most indexes between the two groups at months 1, 3, 6, 12, and >12.","[{'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Rheumatology, Dazhou Central Hospital, Dazhou, China.'}, {'ForeName': 'Jianling', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Department of Rheumatology, Mianyang Central Hospital, Mianyang, China.'}, {'ForeName': 'Shilin', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Clinical Research Center, Dazhou Central Hospital, Dazhou, China.'}, {'ForeName': 'Jiaang', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Department of Rheumatology, Mianyang Central Hospital, Mianyang, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology, Mianyang Central Hospital, Mianyang, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Rheumatology, Mianyang Central Hospital, Mianyang, China.'}, {'ForeName': 'Yuanpiao', 'Initials': 'Y', 'LastName': 'Ni', 'Affiliation': 'Department of Rheumatology, Mianyang Central Hospital, Mianyang, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Clinical Research Center, Dazhou Central Hospital, Dazhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Clinical Research Center, Dazhou Central Hospital, Dazhou, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Clinical Research Center, Dazhou Central Hospital, Dazhou, China.'}, {'ForeName': 'Qianrong', 'Initials': 'Q', 'LastName': 'Xie', 'Affiliation': 'Department of Clinical Research Center, Dazhou Central Hospital, Dazhou, China.'}, {'ForeName': 'Xuejun', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Rheumatology, Dazhou Central Hospital, Dazhou, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Rheumatology, Dazhou Central Hospital, Dazhou, China.'}, {'ForeName': 'Pingxi', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Research Center, Dazhou Central Hospital, Dazhou, China.'}, {'ForeName': 'Fanwei', 'Initials': 'F', 'LastName': 'Zeng', 'Affiliation': 'Department of Clinical Research Center, Dazhou Central Hospital, Dazhou, China.'}, {'ForeName': 'Yanpeng', 'Initials': 'Y', 'LastName': 'Chu', 'Affiliation': 'Department of Clinical Research Center, Dazhou Central Hospital, Dazhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Rheumatology, Mianyang Central Hospital, Mianyang, China.'}, {'ForeName': 'Fanxin', 'Initials': 'F', 'LastName': 'Zeng', 'Affiliation': 'Department of Clinical Research Center, Dazhou Central Hospital, Dazhou, China.'}]",Frontiers in medicine,['10.3389/fmed.2020.00312']
1920,32766263,"Peripheral Enthesitis Detected by Ultrasonography in Patients With Axial Spondyloarthritis-Anatomical Distribution, Morphology, and Response to Tumor Necrosis Factor-Inhibitor Therapy.","Objectives:  To investigate the anatomical distribution, morphological abnormalities and response to adalimumab therapy of ultrasound(US)-detected peripheral enthesitis in patients with axial spondyloarthritis (SpA).  Methods:  In a randomized, placebo-controlled, double-blinded, investigator-initiated trial (NCT01029847), patients with axial SpA according to the Assessment of Spondyloarthritis International Society criteria were randomized to subcutaneous adalimumab 40 mg every other week or placebo from baseline to week 6. From week 6 to 24, all patients received adalimumab 40 mg every other week. Of 49 patients enrolled, 21 patients participated in our observational US sub-study. US assessment applying the OMERACT US definitions for enthesitis of 10 peripheral entheseal regions of the upper and lower extremities and clinical examination were performed at baseline, weeks 6 and 24. US was performed by one experienced investigator. Hypo-echogenicity, increased thickness and Doppler activity of the enthesis were considered signs of active inflammation, whereas insertional bone erosions, intratendinous calcifications, and enthesophytes were regarded as signs of structural lesions.  Results:  Enthesitis on US was mostly present in the lower limbs, especially in the Achilles tendon (81%), the quadriceps tendon (62%), and the greater femoral trochanter (52%). Structural lesions were predominant (38 vs. 12% of examined entheses with inflammatory changes), particularly in the entheses of the lower limbs, and exhibited no change during treatment.  Conclusion:  US-detected structural lesions were common while inflammatory lesions were relatively rare in patients initiating adalimumab due to axial SpA. Structural lesions did not appear to change during 24 weeks follow-up, suggesting that these lesions may not be helpful outcome measures in short-term clinical trials.",2020,"Structural lesions were predominant (38 vs. 12% of examined entheses with inflammatory changes), particularly in the entheses of the lower limbs, and exhibited no change during treatment.  ","['patients with axial SpA according to the Assessment of Spondyloarthritis International Society criteria', 'patients with axial spondyloarthritis (SpA', '49 patients enrolled, 21 patients participated in our observational US sub-study']","['placebo', 'subcutaneous adalimumab 40 mg every other week or placebo', 'adalimumab', 'adalimumab therapy of ultrasound(US)-detected peripheral enthesitis']","['Hypo-echogenicity, increased thickness and Doppler activity', 'quadriceps tendon', 'greater femoral trochanter']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4302634', 'cui_str': 'Adalimumab therapy'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0224941', 'cui_str': 'Structure of quadriceps tendon'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0162370', 'cui_str': 'Trochanter'}]",49.0,0.115992,"Structural lesions were predominant (38 vs. 12% of examined entheses with inflammatory changes), particularly in the entheses of the lower limbs, and exhibited no change during treatment.  ","[{'ForeName': 'Sengul', 'Initials': 'S', 'LastName': 'Seven', 'Affiliation': 'Copenhagen Center for Arthritis Research and Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Susanne Juhl', 'Initials': 'SJ', 'LastName': 'Pedersen', 'Affiliation': 'Copenhagen Center for Arthritis Research and Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Østergaard', 'Affiliation': 'Copenhagen Center for Arthritis Research and Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Sara Kamp', 'Initials': 'SK', 'LastName': 'Felbo', 'Affiliation': 'Copenhagen Center for Arthritis Research and Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Inge Juul', 'Initials': 'IJ', 'LastName': 'Sørensen', 'Affiliation': 'Copenhagen Center for Arthritis Research and Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Uffe Møller', 'Initials': 'UM', 'LastName': 'Døhn', 'Affiliation': 'Copenhagen Center for Arthritis Research and Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Terslev', 'Affiliation': 'Copenhagen Center for Arthritis Research and Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark.'}]",Frontiers in medicine,['10.3389/fmed.2020.00341']
1921,32766301,"Borassus aethiopum -Fortified Bread Reduces Metabolic Risk Factors among Cardiovascular Disease Outpatients at 37 Military Hospital, Accra: A Pilot Study.","Background


Dyslipidemia and hypertension are the leading causes of morbidity and mortality in patients with cardiovascular diseases (CVDs).
Objective


The study sought to evaluate the effects of  Borassus aethiopum -fortified bread on metabolic risk factors among CVD outpatients.
Method


From August 2016 to April 2017, a pilot study using a single-blinded randomized placebo-controlled trial was conducted by administering  Borassus -fortified bread (150 g) and indistinguishable placebo (150 g white flour bread) daily to 122 CVD outpatients at 37 Military Hospital, Accra, Ghana, for 90 days. Body composition, blood pressure, and biochemical parameters were evaluated before and after the intervention.
Results


Following the intervention, the mean waist circumference (before: 98.3 ± 14.6 cm, after: 95.9 ± 15.8 cm,  P  = 0.030), BMI (before: 31.4 ± 6.9 kg/m 2 , after: 28.0 ± 5.8 kg/m 2 ,  P  = 0.027), and visceral fat (before: 10.4 ± 3.2, after: 9.9 ± 3.0,  P  = 0.013), as well as systolic (from 161.2 ± 25.5 to 137.6 ± 22.9and diastolic (from 99.2 ± 13.6 to 85.1 ± 10.8) blood pressure, were significantly reduced among the experimental group. Likewise, serum total cholesterol (TC), LDL, and HDL were significantly reduced within the experimental group before (TC: 5.9 ± 1.1, LDL: 3.4 ± 1.1, and HDL: 2.2 ± 0.5) and after the intervention (TC: 4.9 ± 1.1, LDL: 2.8 ± 0.9, and HDL: 1.5 ± 0.4) (TC:  P  = 0.001, LDL:  P  = 0.016, and HDL:  P  < 0.001, in mmol/L). These reductions were not observed in the controls.
Conclusion


The  Borassus -fortified bread significantly reduced blood pressure and improved lipid profile and other metabolic risk factors among the CVD outpatients studied. Therefore, its potential in the management of CVDs and other metabolic-related diseases should be looked at.",2020,The  Borassus -fortified bread significantly reduced blood pressure and improved lipid profile and other metabolic risk factors among the CVD outpatients studied.,"['Cardiovascular Disease Outpatients at 37 Military Hospital, Accra', '122 CVD outpatients at 37 Military Hospital, Accra, Ghana, for 90 days', 'Method\n\n\nFrom August 2016 to April 2017', 'CVD outpatients', 'patients with cardiovascular diseases (CVDs']","['Borassus -fortified bread (150\u2009g) and indistinguishable placebo', 'Borassus aethiopum -fortified bread', 'placebo']","['blood pressure', 'Likewise, serum total cholesterol (TC), LDL, and HDL', 'mean waist circumference', 'BMI', 'Body composition, blood pressure, and biochemical parameters', 'metabolic risk factors', 'blood pressure and improved lipid profile and other metabolic risk factors', 'visceral fat', 'Metabolic Risk Factors']","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0020012', 'cui_str': 'Military Hospitals'}, {'cui': 'C0017516', 'cui_str': 'Ghana'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}]",,0.0336266,The  Borassus -fortified bread significantly reduced blood pressure and improved lipid profile and other metabolic risk factors among the CVD outpatients studied.,"[{'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Apprey', 'Affiliation': 'Department of Biochemistry and Biotechnology, Faculty of Biosciences, College of Science, Kwame Nkrumah University of Science and Technology, PMB KNUST, Kumasi, Ghana.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Peprah', 'Affiliation': 'Department of Biochemistry and Biotechnology, Faculty of Biosciences, College of Science, Kwame Nkrumah University of Science and Technology, PMB KNUST, Kumasi, Ghana.'}, {'ForeName': 'Reginald Adjetey', 'Initials': 'RA', 'LastName': 'Annan', 'Affiliation': 'Department of Biochemistry and Biotechnology, Faculty of Biosciences, College of Science, Kwame Nkrumah University of Science and Technology, PMB KNUST, Kumasi, Ghana.'}, {'ForeName': 'Marina A', 'Initials': 'MA', 'LastName': 'Tandoh', 'Affiliation': 'Department of Biochemistry and Biotechnology, Faculty of Biosciences, College of Science, Kwame Nkrumah University of Science and Technology, PMB KNUST, Kumasi, Ghana.'}, {'ForeName': 'Odeafo', 'Initials': 'O', 'LastName': 'Asamoah-Boakye', 'Affiliation': 'Department of Biochemistry and Biotechnology, Faculty of Biosciences, College of Science, Kwame Nkrumah University of Science and Technology, PMB KNUST, Kumasi, Ghana.'}]",International journal of food science,['10.1155/2020/2379061']
1922,32766306,Impact of Acute Eccentric versus Concentric Running on Exercise-Induced Fat Oxidation and Postexercise Physical Activity in Untrained Men.,"Introduction


This study aimed at comparing the rate of exercise-induced fat oxidation and postexercise free-living physical activity after constant-load flat running (FR) and downhill running (DHR) bouts at an intensity that elicited maximal fat oxidation.
Methods


Participants were 11 healthy untrained men (mean age 25.6 ± 3.3 years; VO 2max 39.11 ± 8.05 ml/kg/min). The study included four visits. The first two visits determined the intensity of maximal fat oxidation during incremental FR and DHR tests. The second two visits involved constant-load FR or DHR at the intensity that elicited maximal fat oxidation in a counterbalanced order separated by two weeks. Gas exchange analysis was used to measure substrate oxidation during all exercise sessions. Sedentary time and physical activity were measured using ActiGraph triaxial accelerometers for three days including the day of exercise tests (the second day).
Results


During the incremental exercise tests, fat oxidation was significantly greater during the first stage of FR ( P  < 0.05) but started to increase during the fourth stage of DHR, although this did not reach significance. Of the 11 participants, 7 had greater fat oxidation during DHR. During continuous constant-load running, fat oxidation was higher during DHR than FR but at only two stages was either significant or borderline significant, and the time/group interaction was not significant. There was no significant effect on sedentary time of time/group interaction ( P  = 0.769), but there was a significant effect of time ( P  = 0.005), and there was no significant effect on total physical activity of time/group interaction ( P  = 0.283) or time ( P  = 0.602).
Conclusion


Acute aerobic eccentric exercise at an intensity eliciting maximal fat oxidation enhanced exercise-induced fat oxidation without worsening postexercise free-living physical activity, indicating it could be a useful training modality in weight management programs.",2020,"During the incremental exercise tests, fat oxidation was significantly greater during the first stage of FR ( P  < 0.05) but started to increase during the fourth stage of DHR, although this did not reach significance.","['11 healthy untrained men (mean age 25.6 ± 3.3 years; VO 2max 39.11 ± 8.05\u2009ml/kg/min', 'Untrained Men']","['exercise-induced fat oxidation and postexercise free-living physical activity after constant-load flat running (FR) and downhill running (DHR', 'Acute aerobic eccentric exercise', 'Acute Eccentric versus Concentric Running on Exercise-Induced Fat Oxidation and Postexercise Physical Activity']","['total physical activity of time/group interaction', 'sedentary time of time/group interaction', 'intensity of maximal fat oxidation', 'Sedentary time and physical activity', 'substrate oxidation', 'fat oxidation', 'fat oxidation during DHR']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0035953', 'cui_str': 'Running'}]",11.0,0.0290585,"During the incremental exercise tests, fat oxidation was significantly greater during the first stage of FR ( P  < 0.05) but started to increase during the fourth stage of DHR, although this did not reach significance.","[{'ForeName': 'Shaea', 'Initials': 'S', 'LastName': 'Alkahtani', 'Affiliation': 'Department of Exercise Physiology, College of Sport Sciences and Physical Activity, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Aljuhani', 'Affiliation': 'Department of Physical Education, College of Sport Sciences and Physical Activity, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Nasser', 'Initials': 'N', 'LastName': 'Alkhalidi', 'Affiliation': 'Department of Exercise Physiology, College of Sport Sciences and Physical Activity, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Naif', 'Initials': 'N', 'LastName': 'Almasuod', 'Affiliation': 'Department of Exercise Physiology, College of Sport Sciences and Physical Activity, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Hezam', 'Affiliation': 'Department of Exercise Physiology, College of Sport Sciences and Physical Activity, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Aljaloud', 'Affiliation': 'Department of Exercise Physiology, College of Sport Sciences and Physical Activity, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Haitham Abdel Hamid', 'Initials': 'HAH', 'LastName': 'Dawoud', 'Affiliation': 'Department of Sport Health Sciences, Faculty of Physical Education, Helwan University, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Abdusalam', 'Affiliation': 'Department of Biomechanics and Motor Behavior, College of Sport Sciences and Physical Activity, King Saud University, Riyadh, Saudi Arabia.'}]",BioMed research international,['10.1155/2020/2608730']
1923,32766334,"Effectiveness of emotional intelligence training program on marital satisfaction, sexual quality of life, and psychological well-being of women.","CONTEXT


Emotional communications play an important role in having a satisfying relationship and a more successful marriage. If marriage does not provide suitable conditions to satisfy couple's needs, not only it does not help to mental health but also results in negative and irreversible effects.
AIMS


This research was performed with the aim of determining the impact of emotional intelligence training on marital satisfaction, sexual quality of life, and psychological well-being of women.
SETTINGS AND DESIGN


The present research is an experimental study conducted on 70 women referring to community health centers of Shahid Beheshti University of Medical Sciences in 2019.
SUBJECTS AND METHODS


The sampling was performed using multistage cluster sampling. Before implementing the training intervention, the research instruments (general questionnaire, Kansas Marital Satisfaction Scale, Iranian version of Sexual Quality of Life-Female questionnaire, and World Health Organization Five Well-Being Index) were provided to the participants in order to complete them. All participants recompleted the instruments immediately and 1 month after the training intervention.
STATISTICAL ANALYSIS USED


The significance level was considered as  P  < 0.05.
RESULTS


The mean scores of marital satisfaction in the control group had no significant difference before, immediately after, and 1 month after the intervention ( P  = 0.895). However, in the intervention group, over time, the mean scores of marital satisfaction increased ( P  = 0.001), and the difference between the two groups was significant ( P  < 0.001). The mean scores of sexual quality of life and psychological well-being had no significant differences before, immediately after, and 1 month after the intervention in the control group. However, in the intervention group, over time, the mean scores of sexual quality of life and psychological well-being firstly increased and then decreased ( P  < 0.001), and the difference between the two groups was significant ( P  < 0.001).
CONCLUSIONS


Training the components of emotional intelligence can be effective on enhancing marital satisfaction, sexual quality of life, and psychological well-being of women.",2020,"The mean scores of marital satisfaction in the control group had no significant difference before, immediately after, and 1 month after the intervention ( P  = 0.895).",['70 women referring to community health centers of Shahid Beheshti University of Medical Sciences in 2019'],"['emotional intelligence training program', 'emotional intelligence training']","['mean scores of marital satisfaction', 'enhancing marital satisfaction, sexual quality of life, and psychological well-being of women', 'marital satisfaction, sexual quality of life, and psychological well-being of women', 'mean scores of sexual quality of life and psychological well-being firstly', 'research instruments (general questionnaire, Kansas Marital Satisfaction Scale, Iranian version of Sexual Quality of Life-Female questionnaire, and World Health Organization Five Well-Being Index', 'mean scores of sexual quality of life and psychological']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C1510539', 'cui_str': 'Emotional Intelligence'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279901', 'cui_str': 'Firstly'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]",70.0,0.0204812,"The mean scores of marital satisfaction in the control group had no significant difference before, immediately after, and 1 month after the intervention ( P  = 0.895).","[{'ForeName': 'Arezoo Sheikh', 'Initials': 'AS', 'LastName': 'Milani', 'Affiliation': 'Department of Community Health Nursing, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Meimanat', 'Initials': 'M', 'LastName': 'Hosseini', 'Affiliation': 'Department of Community Health Nursing, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Matbouei', 'Affiliation': 'Department of Community Health Nursing, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maliheh', 'Initials': 'M', 'LastName': 'Nasiri', 'Affiliation': 'Department of Biostatistics, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_124_20']
1924,32766336,Comparing the effect of standardized patient-based education and feedback lecture on midwives' knowledge and practice in counseling screening for fetal malformations.,"INTRODUCTION


Midwifery screening is one of the duties of midwives according to national guidelines. It is possible to increase midwives' knowledge and practice through effective education. The aim of this study was to compare the effect of standardized patient-based education and feedback lecture on midwives' knowledge and practice in screening counseling for fetal malformations.
METHODS


This quasi-experimental, two-group study (standardized patient-based training and feedback lecture) was performed on 67 midwives (licensed by the office) in Mashhad in 2018. Midwives' knowledge and practice before and 2 weeks after training (a 4-h training program) were assessed by the Objective Structured Clinical Examination and a questionnaire. The data were analyzed by the SPSS software version 16 using Mann-Whitney, Chi-square, Wilcoxon and independent  t -test while  P  < 0.05 considered as a significant level.
RESULTS


Before intervention, the total score of knowledge and practice showed no statistically significant difference between the two groups ( P  > 0.05). After intervention, knowledge score in feedback lecture group was statistically significantly higher than that of standard patient group ( P  < 0.001). In addition, there was no statistically significant difference in performance scores between the two groups after intervention ( P  = 0.761).
CONCLUSION


Both educational methods can increase midwives' knowledge and practice in fetal screening counseling. However, in raising midwives' awareness, feedback lecture group was more effective than standard patient group.",2020,"Before intervention, the total score of knowledge and practice showed no statistically significant difference between the two groups ( P  > 0.05).","['67 midwives (licensed by the office) in Mashhad in 2018', ""midwives' knowledge and practice in counseling screening for fetal malformations""]",['standardized patient-based education and feedback lecture'],"['total score of knowledge and practice', 'knowledge score', 'performance scores']","[{'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0194532,"Before intervention, the total score of knowledge and practice showed no statistically significant difference between the two groups ( P  > 0.05).","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Javidi-Sarafan', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mahin', 'Initials': 'M', 'LastName': 'Tafazoli', 'Affiliation': 'Department of Midwifery, Evidence-Based Care Research Center, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Talat', 'Initials': 'T', 'LastName': 'Khadivzadeh', 'Affiliation': 'Department of Reproductive Health, Nursing and Midwifery Care Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Mazloum', 'Affiliation': 'Nursing and Midwifery Care Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_521_19']
1925,32766340,Implementing of mental health training programs for promotion of health affected teenage girls to premenstrual syndrome: A community-based study.,"BACKGROUND


Mental health is one of the major determinants of a person's health which has a significant impact on the quality of life. Implementing of mental health training programs for promotion of health affected teenage girls to premenstrual syndrome (PMS) in Shiraz, southern Iran: a community-based study.
MATERIALS AND METHODS


This study is randomized controlled trial done on 100 teenage girls affected to PMS in Shiraz-Iran (selected from400 girls). Multistage cluster sampling method was used  f  or sampling. In the intervention group, six training sessions were held twice a week for 2 h. For data collection, Standard Goldberg Mental Health Questionnaire-28 and Premenstrual Symptoms Screening Tool were used. For data analysis, independent  t -test and Chi-square statistics were used at significant level of 0.05.
RESULTS


The average age was (16.56 ± 0.92) and (16.24 ± 1.45) in the intervention and control groups, respectively. The average intensity of physical complaints, level of anxiety and sleep disorder, level of social functions disorders and depression were significantly lower in the group of training classes than control group ( P  < 0.001).
CONCLUSION


Appropriate training-care programs are effective in reducing stress and improving mental health, prevention and treatment of mental disorders, emotional growth, and development of communication skills among female students with premenstrual syndrome.",2020,"The average intensity of physical complaints, level of anxiety and sleep disorder, level of social functions disorders and depression were significantly lower in the group of training classes than control group ( P  < 0.001).
","['health affected teenage girls to premenstrual syndrome (PMS) in Shiraz, southern Iran', 'health affected teenage girls to premenstrual syndrome', '100 teenage girls affected to PMS in Shiraz-Iran (selected from400 girls', 'female students with premenstrual syndrome']",['mental health training programs'],"['average intensity of physical complaints, level of anxiety and sleep disorder, level of social functions disorders and depression']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033046', 'cui_str': 'Premenstrual syndrome'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",100.0,0.0319932,"The average intensity of physical complaints, level of anxiety and sleep disorder, level of social functions disorders and depression were significantly lower in the group of training classes than control group ( P  < 0.001).
","[{'ForeName': 'Maliheh', 'Initials': 'M', 'LastName': 'Abootalebi', 'Affiliation': 'Department of Community Health Nursing, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mansoureh', 'Initials': 'M', 'LastName': 'Dehghani', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Akbarzadeh', 'Affiliation': 'Department of Midwifery, Maternal-Fetal Medicine Research Center, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_118_20']
1926,32766341,Promoting health and quality of life of patients with osteoarthritis of knee joint through non-pharmacological treatment strategies: A randomized controlled trial.,"BACKGROUND AND OBJECTIVE


Osteoarthritis (OA) is a chronic degenerative disorder which primarily affects the articular cartilage of synovial joints followed by bony remodeling and overgrowth at the margins of these joints. The consequences of OA are pain, joint stiffness, decreased muscle performance, and decreased aerobic capacity, which eventually affect the quality of life (QOL) and increased risk for disability. The objective of the present study was to investigate the effectiveness of two nonpharmacological treatment regimens, that is, yoga and conventional physiotherapy, on QOL in patients suffering from OA of knee joint.
MATERIALS AND METHODS


A total of 83 patients with bilateral OA of knee joint, between the age group of 40 and 80 years, both males and females, were assigned into two groups using computer-generated scheme: 43 in the experimental group (yoga with conventional physiotherapy program) and 40 in control group (conventional physiotherapy program). Western Ontario and McMaster Universities OA index (WOMAC) and Short-Form 36 (SF-36) health survey were measured before, after 15 days, and after 30 days of treatment sessions, and the data were analyzed using paired and unpaired  t -test.
RESULTS


The results of the study show significant improvement in both groups with regard to WOMAC and SF-36 at the end of 15 and 30 days of treatment regimen; however, when compared to the control group, experimental group had more significant improvement ( P  < 0.05) in WOMAC and SF-36 at the end of 15 and 30 days of treatment.
CONCLUSION


Yoga is more beneficial when added to conventional physiotherapy treatment regimen in promoting health and improving QOL in patients with OA of knee joint.",2020,"The results of the study show significant improvement in both groups with regard to WOMAC and SF-36 at the end of 15 and 30 days of treatment regimen; however, when compared to the control group, experimental group had more significant improvement ( P  < 0.05) in WOMAC and SF-36 at the end of 15 and 30 days of treatment.
","['patients suffering from OA of knee joint', 'patients with osteoarthritis of knee joint through non-pharmacological treatment strategies', '83 patients with bilateral OA of knee joint, between the age group of 40 and 80 years, both males and females', 'patients with OA of knee joint']","['computer-generated scheme: 43 in the experimental group (yoga with conventional physiotherapy program) and 40 in control group (conventional physiotherapy program', 'yoga and conventional physiotherapy']","['Promoting health and quality of life', 'OA are pain, joint stiffness, decreased muscle performance, and decreased aerobic capacity', 'quality of life (QOL) and increased risk for disability', 'WOMAC and SF-36', 'Western Ontario and McMaster Universities OA index (WOMAC) and Short-Form 36 (SF-36) health survey']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4757989', 'cui_str': 'Bilateral osteoarthritis of knees'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0162298', 'cui_str': 'Joint stiffness'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",83.0,0.0345913,"The results of the study show significant improvement in both groups with regard to WOMAC and SF-36 at the end of 15 and 30 days of treatment regimen; however, when compared to the control group, experimental group had more significant improvement ( P  < 0.05) in WOMAC and SF-36 at the end of 15 and 30 days of treatment.
","[{'ForeName': 'Nirav', 'Initials': 'N', 'LastName': 'Vaghela', 'Affiliation': 'Department of Physiotherapy, K M Patel Institute of Physiotherapy, H M Patel Centre for Medical Care and Education, Shree Krishna Hospital, Karamsad, Anand, India.'}, {'ForeName': 'Daxa', 'Initials': 'D', 'LastName': 'Mishra', 'Affiliation': 'Department of Physiotherapy, K M Patel Institute of Physiotherapy, H M Patel Centre for Medical Care and Education, Shree Krishna Hospital, Karamsad, Anand, India.'}, {'ForeName': 'Jayshree', 'Initials': 'J', 'LastName': 'Patel', 'Affiliation': 'Physiotherapist, Himatnagar, Gujarat, India.'}, {'ForeName': 'Vyoma', 'Initials': 'V', 'LastName': 'Dani', 'Affiliation': 'Department of Physiotherapy, K M Patel Institute of Physiotherapy, H M Patel Centre for Medical Care and Education, Shree Krishna Hospital, Karamsad, Anand, India.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_39_20']
1927,32766406,The Effect of Suspension and Conventional Core Stability Exercises on Characteristics of Intervertebral Disc and Chronic Pain in Office Staff Due to Lumbar Herniated Disc.,"Background


The purpose of this study was to identify the effects of eight weeks of conventional and suspension core stability exercises by use of the designed device on characteristic of intervertebral discs in low back pain.
Methods


A total of 27 men with chronic low back (CLB) pain due to lumbar disc herniation in L4-L5 and L5-S1 regions were enrolled in this quasi-experimental study. After assessing the pain intensity using a visual analog scale (VAS) and determining the disc herniation index using MRI, each group of patients were asked to perform either conventional or suspension exercises for eight weeks, each week consisting of three training sessions. The pain intensity was assessed at the end of the first, second, third, fourth and eighth weeks and the disc hernia index was determined again at the end of the eight weeks of exercises.
Results


The results indicated significant changes in the intensity of pain in both groups through the period of eight weeks of exercise with a remarkable pain relief. In relation to the structural characteristics of the intervertebral disc, data analysis did not reveal any significant change between the pre- and post-test.
Conclusion


Considering the beneficial effects of the stability exercises and specially suspension stability exercises with respect to pain alleviation and reduced use of sedatives and anti-inflammatory drugs, this method can be helpful at early stages of treatment for chronic pains.",2020,"In relation to the structural characteristics of the intervertebral disc, data analysis did not reveal any significant change between the pre- and post-test.
","['Office Staff Due to Lumbar Herniated Disc', '27 men with chronic low back (CLB) pain due to lumbar disc herniation in L4-L5 and L5-S1 regions']","['conventional or suspension exercises', 'stability exercises and specially suspension stability exercises', 'conventional and suspension core stability exercises', 'Suspension and Conventional Core Stability Exercises']","['Characteristics of Intervertebral Disc and Chronic Pain', 'pain relief', 'pain intensity using a visual analog scale (VAS', 'pain intensity', 'disc hernia index', 'intensity of pain']","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0444669', 'cui_str': 'Core'}]","[{'cui': 'C0021815', 'cui_str': 'Structure of intervertebral disc'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",27.0,0.0281409,"In relation to the structural characteristics of the intervertebral disc, data analysis did not reveal any significant change between the pre- and post-test.
","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Khanzadeh', 'Affiliation': 'Department of Physical Education Faculty of Sports Sciences, Isfahan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Mahdavinejad', 'Affiliation': 'Department of Physical Education Faculty of Sports Sciences, Isfahan, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Borhani', 'Affiliation': 'Department of Radiology, Tehran, Iran.'}]",The archives of bone and joint surgery,['10.22038/abjs.2019.40758.2102']
1928,32766430,Educational Animations to Inform Transplant Candidates About Deceased Donor Kidney Options: An Efficacy Randomized Trial.,"Background


Transplant candidates struggle making decisions about accepting kidneys with variable kidney donor profile index (KDPI) and increased risk donor (IRD) status.
Methods


This single site, pilot randomized controlled trial evaluated the efficacy of 2 animations to improve KDPI/IRD knowledge, decisional self-efficacy, and willingness. Kidney candidates were randomly assigned to animation viewing plus standard nurse discussion (intervention) or standard nurse discussion alone (control). Linear regression was used to test the significance of animation exposure after controlling for covariates (α < 0.1).
Results


Mean age was 60 years, and 27% were African American. Both intervention (n = 42) and control (n = 38) groups received similar education at similar duration (12.8 versus 11.8 min, respectively), usually by the same dedicated nurse educator (85% versus 75%, respectively). On multivariate analysis, the intervention group (versus control) exhibited significantly increased knowledge (β = 0.23; 95% confidence interval, 0.66-1.77) and IRD willingness (β = 0.22; 95% confidence interval, 0.05-0.86). There were no between-group differences in KDPI >85% willingness or distribution of KDPI/IRD decisional self-efficacy. Over 90% of participants provided positive ratings on each of 11 acceptability items.
Conclusions


Supporting conventional IRD and KDPI education with educational animations can improve knowledge and IRD willingness compared with standard methods.",2020,There were no between-group differences in KDPI >85% willingness or distribution of KDPI/IRD decisional self-efficacy.,"['Kidney candidates', 'Mean age was 60 years, and 27% were African American']",['animation viewing plus standard nurse discussion (intervention) or standard nurse discussion alone (control'],"['KDPI >85% willingness or distribution of KDPI/IRD decisional self-efficacy', 'knowledge and IRD willingness', 'IRD willingness', 'KDPI/IRD knowledge, decisional self-efficacy, and willingness']","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085756', 'cui_str': 'African American'}]","[{'cui': 'C0376650', 'cui_str': 'Animation'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0260788', 'cui_str': 'Donor of kidney for transplant'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.112547,There were no between-group differences in KDPI >85% willingness or distribution of KDPI/IRD decisional self-efficacy.,"[{'ForeName': 'Liise K', 'Initials': 'LK', 'LastName': 'Kayler', 'Affiliation': 'Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Dolph', 'Affiliation': 'Department of Surgery, University at Buffalo, Buffalo, NY.'}, {'ForeName': 'Chelsea N', 'Initials': 'CN', 'LastName': 'Cleveland', 'Affiliation': 'Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY.'}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Keller', 'Affiliation': 'Department of Community Health and Health Behavior, University at Buffalo, State University of New York, Buffalo, NY.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Feeley', 'Affiliation': 'Department of Communication, University at Buffalo, State University of New York, Buffalo, NY.'}]",Transplantation direct,['10.1097/TXD.0000000000001026']
1929,32766465,Conditioning open-label placebo: a pilot pharmacobehavioral approach for opioid dose reduction and pain control.,"Opioid consumption for those in comprehensive inpatient rehabilitation units is high because of the complexity of their injuries. Notably, pain in rehabilitation leads to worsened clinical outcomes because of maladaptive behaviors and poor engagement during therapies. It is critical to developing evidence-based pharmacobehavioral interventions. Based on principles of classical conditioning, conditioning open-label placebo (COLP) is a promising approach for reducing opioid use in comprehensive inpatient rehabilitation, and this technique takes advantage of the possibility of association learning and opioid pharmacology to promote evoked placebo-driven analgesia.
Objectives


In this brief report, we evaluate the feasibility of COLP as a pharmacobehavioral intervention to decrease total opioid consumption in patients with pain hospitalized at Spaulding Rehabilitation Hospital.
Methods


Inpatients with spinal cord injury and polytrauma (n = 20) with moderate to severe pain were randomized to receive COLP (n = 10) or treatment-as-usual for 6 consecutive days. Opioid utilization was measured by morphine equivalents using the morphine equivalent dose conversion; pain severity was assessed using the numerical visual analog scale.
Results


Conditioning open-label placebo significantly reduced total opioid consumption by the end of the intervention period ( P  ≤ 0.001). Pain reduction was also significant for the COLP group ( P  = 0.005), whereas the treatment-as-usual group demonstrated a trend towards pain reduction ( P  = 0.05).
Conclusions


This study presents the first data in the use of a pharmacobehavioral intervention that capitalize on the benefits of open-label placebo and classical drug conditioning for opioid dose reduction in a population with moderate to severe pain exposed to intensive inpatient rehabilitation.",2020,"Pain reduction was also significant for the COLP group ( P  = 0.005), whereas the treatment-as-usual group demonstrated a trend towards pain reduction ( P  = 0.05).
","['population with moderate to severe pain exposed to intensive inpatient rehabilitation', 'Methods\n\n\nInpatients with spinal cord injury and polytrauma (n = 20) with moderate to severe pain', 'patients with pain hospitalized at Spaulding Rehabilitation Hospital']","['Conditioning open-label placebo', 'COLP', 'classical conditioning, conditioning open-label placebo (COLP', 'pharmacobehavioral intervention']","['pain reduction', 'pain control', 'Opioid utilization', 'total opioid consumption', 'Pain reduction']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0026771', 'cui_str': 'Multiple injuries'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009649', 'cui_str': 'Conditioning, Classical'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",20.0,0.0633245,"Pain reduction was also significant for the COLP group ( P  = 0.005), whereas the treatment-as-usual group demonstrated a trend towards pain reduction ( P  = 0.05).
","[{'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Morales-Quezada', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Mesia-Toledo', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Anayali', 'Initials': 'A', 'LastName': 'Estudillo-Guerra', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Schneider', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Sohn', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Crandell', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Kaptchuk', 'Affiliation': 'Program in Placebo Studies and Therapeutic Encounter, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Zafonte', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA.'}]",Pain reports,['10.1097/PR9.0000000000000828']
1930,32766514,Determination of Anesthetic Efficacy of Lidocaine Versus Bupivacaine in Single Visit Root Canal Treatment.,"Objective


To compare the anesthetic efficacy of 2% Lidocaine with 1:80,000 epinephrine and 0.5% Bupivacaine with 1:200,000 epinephrine in one-visit root canal treatment in patients with symptomatic irreversible pulpitis.
Methods


A total of 60 patients presenting with symptomatic irreversible pulpitis with normal periapical tissues on periapical radiography of mandibular 1 st  and 2 nd  molars, reporting moderate to severe pain as assessed by visual analogue scale (VAS) for at least 24 hours were included in this study. All patients received local anesthesia via the inferior alveolar nerve block technique by the investigator. These patients were randomly allocated into two groups in which first group received 2% lidocaine with 1:80,000 epinephrine and the second group received 0.5% bupivacaine with 1:200,000 epinephrine. Patients were instructed to rate the intensity of pain during root canal treatment which was then noted on visual analogue scale (VAS).
Results


The average age of the patients was 34.15±9.49 years, in which 32 (53.3%) were male and 28 (46.7%) were female. The anesthetic efficacy was significantly high in bupivacaine as compared to lidocaine local anesthesia group (76.7% versus 40%; P=0.004).
Conclusion


The administration of bupivacaine anesthetic agent for inferior alveolar nerve block (IANB) injections can be a better and appropriate pain management aid as compared to lidocaine during root canal treatment of patient with symptomatic irreversible pulpitis.",2020,"The anesthetic efficacy was significantly high in bupivacaine as compared to lidocaine local anesthesia group (76.7% versus 40%; P=0.004).
","['patient with symptomatic irreversible pulpitis', 'Single Visit Root Canal Treatment', 'patients with symptomatic irreversible pulpitis', 'The average age of the patients was 34.15±9.49 years, in which 32 (53.3%) were male and 28 (46.7%) were female', '60 patients presenting with symptomatic irreversible pulpitis with normal periapical tissues on periapical radiography of mandibular 1 st  and 2 nd  molars, reporting moderate to severe pain as assessed by visual analogue scale (VAS) for at least 24 hours were included in this study']","['bupivacaine anesthetic agent', 'bupivacaine with 1:200,000 epinephrine', 'bupivacaine', 'Lidocaine', 'Lidocaine Versus Bupivacaine', 'lidocaine', 'lidocaine local anesthesia', 'epinephrine and 0.5% Bupivacaine with 1:200,000 epinephrine', 'lidocaine with 1:80,000 epinephrine', 'local anesthesia via the inferior alveolar nerve block technique by the investigator']","['visual analogue scale (VAS', 'anesthetic efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C4041064', 'cui_str': 'Normal periapical tissue'}, {'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",60.0,0.0548869,"The anesthetic efficacy was significantly high in bupivacaine as compared to lidocaine local anesthesia group (76.7% versus 40%; P=0.004).
","[{'ForeName': 'Rizwan', 'Initials': 'R', 'LastName': 'Jouhar', 'Affiliation': 'Department of Restorative Dentistry and Endodontics, College of Dentistry, King Faisal Univeristy, Al Ahsa, Saudi Arabia.'}, {'ForeName': 'Muhammad Adeel', 'Initials': 'MA', 'LastName': 'Ahmed', 'Affiliation': 'Department of Restorative Dentistry and Endodontics, College of Dentistry, King Faisal Univeristy, Al Ahsa, Saudi Arabia.'}, {'ForeName': 'Bushra', 'Initials': 'B', 'LastName': 'Ghani', 'Affiliation': 'Department of Operative Dentistry and Endodontics, Altamash Institute of Dental Medicine, Sindh, Pakistan.'}]",European endodontic journal,['10.14744/eej.2020.88597']
1931,32774864,The effect of regular aerobic exercise on sleep quality and fatigue among female student dormitory residents.,"Background


Emerging research shows a high prevalence of fatigue and sleep problems among university students. The present study evaluates the effects of regular aerobic exercise on sleep quality and fatigue level among female students (ages 18-26) who reside in dormitories.
Methods


This quasi-experimental study involving 67 participants consisted of one experimental group (i.e., assigned aerobic exercise) and one control group (i.e., not assigned aerobic exercise). Participants in the experimental group received three one-hour sessions aerobic exercise weekly ranging from mild to moderate intensity for eight-week. Sleep quality and fatigue level were evaluated using the Pittsburgh Sleep Quality Index (PSQI) and standard Multidimensional Fatigue Inventory (MFI-20), respectively. These variables were assessed at baseline, week four, and week eight of the study.
Results


After four and 8 weeks of the intervention, participants in the aerobic group showed improvement in the score of sleep quality ( p  < 0.001 and  p  < 0.0001, respectively) and its components (except for sleep duration after 4 weeks intervention). Also, aerobic exercise resulted in a significant reduction of the total score of fatigue and its dimensions in weeks four and eight, compared to the control group ( p  < 0.001).
Conclusions


Four-week aerobic exercise with mild intensity had no significant effect on sleep duration. Conversely, intensified aerobic exercise for 8 weeks influenced all components of sleep quality.
Trial registration


The study was registered on 6/2/2015 in the Iranian Registry of Clinical Trials (IRCT) with number IRCT201412282324N15.",2020,"Also, aerobic exercise resulted in a significant reduction of the total score of fatigue and its dimensions in weeks four and eight, compared to the control group ( p  < 0.001).
","['university students', 'female students (ages 18-26) who reside in dormitories', 'female student dormitory residents', '67 participants consisted of one experimental group (i.e., assigned']","['aerobic exercise) and one control group (i.e., not assigned aerobic exercise', 'intensified aerobic exercise', 'regular aerobic exercise', 'aerobic exercise']","['score of sleep quality', 'Pittsburgh Sleep Quality Index (PSQI) and standard Multidimensional Fatigue Inventory (MFI-20', 'sleep duration', 'Sleep quality and fatigue level', 'sleep quality', 'sleep quality and fatigue', 'total score of fatigue and its dimensions', 'sleep quality and fatigue level']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",67.0,0.079635,"Also, aerobic exercise resulted in a significant reduction of the total score of fatigue and its dimensions in weeks four and eight, compared to the control group ( p  < 0.001).
","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Ezati', 'Affiliation': 'Department of Midwifery and Reproductive Health, Faculty of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Keshavarz', 'Affiliation': 'Department of Midwifery and Reproductive Health, Faculty of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra Amirkhanzadeh', 'Initials': 'ZA', 'LastName': 'Barandouzi', 'Affiliation': 'School of Nursing, University of Connecticut, Storrs, CT USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Montazeri', 'Affiliation': 'Population Health Research Group, Health Metrics Research Center, Iranian Institute for Health Sciences Research, ACECR, Tehran, Iran.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-020-00190-z']
1932,32774875,"Effect of a nutrition education programme on the metabolic syndrome in type 2 diabetes mellitus patients at a level 5 Hospital in Kenya: ""a randomized controlled trial"".","Background


Type 2 diabetes mellitus (T2D), is a life-threatening condition of global public health concern. It worsens in the presence of the metabolic syndrome (MetS), a complex disorder characterized by co-occurrence of at least three of such factors as hypertension, obesity, dyslipidemia and insulin resistance. However, lifestyle interventions reduce the risk of both MetS and T2D, and nutrition education can empower individuals on the appropriate, lifestyle changes. The aim of the current study was to evaluate the effect of a nutrition education programme, with and without inclusion of peer to peer support, on MetS in T2D patients.
Methods


This was a randomized controlled trial with two intervention groups and one control. One of the intervention groups involved a nutrition education programme with peer-to-peer support (NEP); the other involved only the education program, while the control received standard care. Each group had 51 participants. The nutrition education programme was conducted for 2 h per week for 8 weeks. In addition, the NEP had weekly peer-to-peer interactions for 8 weeks. All groups had follow-up sessions for 6 months. Data on MetS risk factors as well as food intake patterns and physical activity levels were taken at baseline and at different time points during the study. Analysis of Co-variance and regression were used in the analysis.
Results


The MetS prevalence improved in the NEP (90 to 52%) and NE (86 to 69%), while it worsened in C (88 to 91%). There was improvement in the mean values of the anthropometric parameters in the NEP and NE which worsened in the control group. There was a general improvement in mean values of blood lipids, fasting blood glucose and HbA1c in all the groups, with NEP showing the greatest improvements, followed by NE, except for triglycerides and HDL where the control group had better improvement than the NE. Changes in the anthropometric and metabolic indicators mirrored the changes in food intake patterns and physical activity, where the greatest improvements occurred in the NEP.
Conclusions


Nutrition education with inclusion of peer to peer support was of clinical benefit in improving metabolic outcomes and reducing MetS in T2DM patients.
Trial registration


The study has been registered retrospectively by Pan African Clinical Trial Registry; Registration No: PACTR201910518676391.",2020,"There was a general improvement in mean values of blood lipids, fasting blood glucose and HbA1c in all the groups, with NEP showing the greatest improvements, followed by NE, except for triglycerides and HDL where the control group had better improvement than the NE.","['T2D patients', 'type 2 diabetes mellitus patients at a level 5 Hospital in Kenya', 'T2DM patients']","['NEP', 'nutrition education programme', 'nutrition education programme with peer-to-peer support (NEP); the other involved only the education program, while the control received standard care']","['mean values of blood lipids, fasting blood glucose and HbA1c', 'MetS prevalence', 'triglycerides and HDL', 'risk of both MetS and T2D, and nutrition education', 'mean values of the anthropometric parameters', 'food intake patterns and physical activity levels', 'metabolic syndrome', 'food intake patterns and physical activity']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0430069,"There was a general improvement in mean values of blood lipids, fasting blood glucose and HbA1c in all the groups, with NEP showing the greatest improvements, followed by NE, except for triglycerides and HDL where the control group had better improvement than the NE.","[{'ForeName': 'Ann Watetu', 'Initials': 'AW', 'LastName': 'Thuita', 'Affiliation': 'School of Food and Nutrition Sciences, Department of Human Nutrition Sciences, Jomo Kenyatta University of Agriculture and Technology, Juja, Kenya.'}, {'ForeName': 'Beatrice Nyanchama', 'Initials': 'BN', 'LastName': 'Kiage', 'Affiliation': 'School of Food and Nutrition Sciences, Department of Human Nutrition Sciences, Jomo Kenyatta University of Agriculture and Technology, Juja, Kenya.'}, {'ForeName': 'Arnold N', 'Initials': 'AN', 'LastName': 'Onyango', 'Affiliation': 'School of Food and Nutrition Sciences, Department of Human Nutrition Sciences, Jomo Kenyatta University of Agriculture and Technology, Juja, Kenya.'}, {'ForeName': 'Anselimo O', 'Initials': 'AO', 'LastName': 'Makokha', 'Affiliation': 'School of Food and Nutrition Sciences, Department of Human Nutrition Sciences, Jomo Kenyatta University of Agriculture and Technology, Juja, Kenya.'}]",BMC nutrition,['10.1186/s40795-020-00355-6']
1933,32774889,Preoperative exercise in patients undergoing total knee arthroplasty: a pilot randomized controlled trial.,"Background


The purpose of this study was to assess the effect of preoperative physiotherapy (PT) on functional, subjective and socio-economic parameters after total knee arthroplasty (TKA).
Methods


20 patients (mean ± SD: age 67 ± 7 years) scheduled for TKA at Balgrist University Hospital between July 2016 and March 2017 were randomly assigned to a control (CG) or intervention (IG) group. 3 to 4 weeks prior to surgery the IG completed 5 to 9 sessions of PT containing proprioceptive neuromuscular facilitation (PNF) techniques, endurance training and individually indicated interventions. Measurements were executed at baseline, preoperative and 3 months after TKA. The primary outcome measure was the Stair Climbing Test (SCT), secondary outcome measures were the knee range of motion (ROM) and the level of physical activity using Lysholm Score (LS) and Tegner Activity Scale (TAS). The subjective and socio-economic parameters were the Patients' Global Impression of Change (PGIC) scale, inpatient rehabilitation time, preoperative pain levels and metabolic equivalent (MET), postoperative intake of analgesics and overall costs.
Results


No difference between IG and CG was found for SCT (F (2/36) = 0.016,  p  = 0.984, η2 = 0.004). An interaction between group and time was shown for TAS (F (18/1) = 13.890) with an increase in the IG ( p  = 0.002, η2 = 0.536). The sub-item ""pain"" within the LS presented a higher pain-level in CG (F (18/1) = 4.490,  p  = 0.048, η2 = 0.974), while IG showed a higher preoperative MET compared to CG ( p  = 0.035). There were no other significant changes. The CG produced 21.4% higher overall costs, took more analgesics and showed higher preoperative pain levels than the IG.
Conclusions


Findings show that preoperative therapy improved the level of physical activity before and after TKA and resulted in a clinically relevant gain in TAS.
Trial registration


ClinicalTrials.gov Identifier; NCT03160534. Registered 19 May 2017.",2020,"No difference between IG and CG was found for SCT (F (2/36) = 0.016,  p  = 0.984, η2 = 0.004).","['20 patients (mean\u2009±\u2009SD: age 67\u2009±\u20097\u2009years) scheduled for TKA at Balgrist University Hospital between July 2016 and March 2017', 'total knee arthroplasty (TKA', 'patients undergoing total knee arthroplasty']","['PT containing proprioceptive neuromuscular facilitation (PNF) techniques, endurance training and individually indicated interventions', 'preoperative physiotherapy (PT', 'control (CG) or intervention (IG', 'Preoperative exercise']","['Stair Climbing Test (SCT', 'overall costs', 'knee range of motion (ROM) and the level of physical activity using Lysholm Score (LS) and Tegner Activity Scale (TAS', 'preoperative pain levels', 'Global Impression of Change (PGIC) scale, inpatient rehabilitation time, preoperative pain levels and metabolic equivalent (MET), postoperative intake of analgesics and overall costs', 'level of physical activity', 'functional, subjective and socio-economic parameters', 'pain-level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0430519', 'cui_str': 'Stair-climbing test'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3850078', 'cui_str': 'Tegner Activity Level'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2355577', 'cui_str': 'Metabolic Equivalent'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0913551,"No difference between IG and CG was found for SCT (F (2/36) = 0.016,  p  = 0.984, η2 = 0.004).","[{'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Gränicher', 'Affiliation': 'The University Center for Prevention and Sports Medicine (UCePS), Balgrist University Hospital, Forchstrasse 319, 8008 Zurich, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Stöggl', 'Affiliation': 'Department of Sport and Exercise Science, University of Salzburg, Schlossallee 49, 5400 Hallein/Rif, Austria.'}, {'ForeName': 'Sandro F', 'Initials': 'SF', 'LastName': 'Fucentese', 'Affiliation': 'Department of Orthopaedic Surgery, Balgrist University Hospital, University of Zurich, Forchstrasse 340, 8008 Zurich, Switzerland.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Adelsberger', 'Affiliation': 'Wearable Computing Lab Zurich, ETH Zurich, Gloriastrasse 35, 8092 Zurich, Switzerland.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Swanenburg', 'Affiliation': 'Integrative Spinal Research ISR, Department of Chiropractic Medicine, Balgrist University Hospital, Forchstrasse 340, 8008 Zurich, Switzerland.'}]",Archives of physiotherapy,['10.1186/s40945-020-00085-9']
1934,32774903,The Relationship between Anterior Chamber Angle and Intraocular Pressure Early after V4c Implantable Collamer Lens Implantation.,"Purpose


To confirm the relationship between anterior chamber angle (ACA) and intraocular pressure (IOP) early after V4c implantable collamer lens (ICL) implantation.
Methods


Patients were assigned to two groups: (1) right eyes (control group) and (2) left eyes (experimental group), with miosis conducted immediately after ICL implantation in the left eyes. IOP, angle opening distance (AOD), trabecular-iris angle (TIA), and pupil diameter (PD) were compared between two groups at postoperative hours 1, 2, and 24. The relationship between ACA, PD, and IOP was analyzed by multiple linear regression.
Result


Thirty-six eyes of 18 patients were enrolled. The prevalence of ocular hypertension (OHT, defined as IOP ≥ 21 mmHg) was 61.11% and 16.67% in the right and left eyes, respectively, ( χ   2  = 7.481,  p =0.006). At postoperative hours 1 and 2, IOP and PD were significantly higher ( p  < 0.001) in the right eyes, and TIA and AOD were significantly lower ( p  < 0.05) in the right eyes than in the left eyes. There was no significant difference at 24 h postoperative in these parameters. After the right eye ICL implantation, the changes of AOD 500 and PD were both linearly correlated with postoperative IOP change ( β  = -23.707 and 1.731, respectively;  p  = 0.013 and 0.002, respectively).
Conclusion


The ACA was significantly narrowed immediately after V4c ICL implantation. There was a negative linear correlation between ACA and early IOP and a positive linear correlation between PD and early IOP. We recommend the use of intracameral miotics immediately after V4c ICL implantation to reduce the incidence of IOP spikes.",2020,"At postoperative hours 1 and 2, IOP and PD were significantly higher ( p  < 0.001) in the right eyes, and TIA and AOD were significantly lower ( p  < 0.05) in the right eyes than in the left eyes.",['Result\n\n\nThirty-six eyes of 18 patients were enrolled'],"['Anterior Chamber Angle and Intraocular Pressure Early after V4c Implantable Collamer Lens Implantation', 'right eyes (control group) and (2) left eyes (experimental group), with miosis conducted immediately after ICL implantation', 'intracameral miotics', 'anterior chamber angle (ACA) and intraocular pressure (IOP) early after V4c implantable collamer lens (ICL) implantation']","['right eyes, and TIA and AOD', 'ACA, PD, and IOP', 'incidence of IOP spikes', 'IOP, angle opening distance (AOD), trabecular-iris angle (TIA), and pupil diameter (PD', 'postoperative IOP change', 'IOP and PD', 'prevalence of ocular hypertension (OHT', 'changes of AOD 500 and PD']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0229238', 'cui_str': 'Structure of iridocorneal angle'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0229089', 'cui_str': 'Right eye structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026205', 'cui_str': 'Persistent miosis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0026207', 'cui_str': 'Miotic'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0229089', 'cui_str': 'Right eye structure'}, {'cui': 'C0022077', 'cui_str': 'Iris structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0229238', 'cui_str': 'Structure of iridocorneal angle'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C3816747', 'cui_str': '500'}]",18.0,0.0535421,"At postoperative hours 1 and 2, IOP and PD were significantly higher ( p  < 0.001) in the right eyes, and TIA and AOD were significantly lower ( p  < 0.05) in the right eyes than in the left eyes.","[{'ForeName': 'Zongli', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Department of Ophthalmology, Daping Hospital, Army Medical University, Chongqing 400042, China.'}, {'ForeName': 'Chunlin', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology, Daping Hospital, Army Medical University, Chongqing 400042, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'Department of Ophthalmology, Daping Hospital, Army Medical University, Chongqing 400042, China.'}, {'ForeName': 'Rongdi', 'Initials': 'R', 'LastName': 'Yuan', 'Affiliation': 'Department of Ophthalmology, Xinqiao Hospital, Army Medical University, Chongqing 400037, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of Ophthalmology, Daping Hospital, Army Medical University, Chongqing 400042, China.'}]",Journal of ophthalmology,['10.1155/2020/4014512']
1935,32775182,Topical 5-fluorouracil application in management of odontogenic keratocysts.,"Aim & objectives


The aim of this study was to evaluate the efficacy of topical application of 5-fluorouracil (5-FU) after peripheral ostectomy, and compare it with other treatment modalities in the management of odontogenic keratocyst (OKC).
Materials &methods


This prospective study was conducted in the OMFS department for last seven years, wherein twenty seven patients of OKC were included and randomly allocated to the three treatment groups. Nine were treated by enucleation followed by application of modified carnoy solution (CS), eleven by peripheral ostectomy followed by application of 5-FU and eleven by segmental resection (SR). Follow-up ranged from 2 to 4 years to assess bone healing and record any recurrence of lesion.
Results


Amongst twenty seven patients, eighteen were males and nine females, age range 20-66 years. The most common location of OKC was posterior mandible. Complications included nerve injury, swelling, infection, and recurrence (66.6% after modified CS). Functional and aesthetic compromise was seen in resection patients whereas application of 5-FU had minimal nerve injuries, infection, swelling, no recurrence with no compromise in aesthetics and function.
Conclusion


Management of OKC by 5-FU is a novel surgical method having less morbidity, minimal recurrence, low cost, no functional or cosmetic deformity.",2020,"Functional and aesthetic compromise was seen in resection patients whereas application of 5-FU had minimal nerve injuries, infection, swelling, no recurrence with no compromise in aesthetics and function.
","['OMFS department for last seven years, wherein twenty seven patients of OKC', 'twenty seven patients, eighteen were males and nine females, age range 20-66 years']","['Topical 5-fluorouracil application', 'enucleation followed by application of modified carnoy solution (CS), eleven by peripheral ostectomy followed by application of 5-FU and eleven by segmental resection (SR', '5-FU', '5-fluorouracil (5-FU']","['bone healing and record any recurrence of lesion', 'nerve injury, swelling, infection, and recurrence', 'Functional and aesthetic compromise']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0341038', 'cui_str': 'Odontogenic keratocyst'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C3215191', 'cui_str': 'Fluorouracil-containing product in cutaneous dose form'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0054815', 'cui_str': ""Carnoy's solution""}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0302269', 'cui_str': 'Excision of bone'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0161479', 'cui_str': 'Nerve injury'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}]",,0.0148761,"Functional and aesthetic compromise was seen in resection patients whereas application of 5-FU had minimal nerve injuries, infection, swelling, no recurrence with no compromise in aesthetics and function.
","[{'ForeName': 'Parveen', 'Initials': 'P', 'LastName': 'Akhter Lone', 'Affiliation': 'Indira Gandhi Government Dental College Amphalla Jammu Affiliated to University of Jammu, India.'}, {'ForeName': 'Nisar', 'Initials': 'N', 'LastName': 'Ahmed Wani', 'Affiliation': 'Consultant Pediatric Radio Diagnosis GB Pant Hospital Srinagar Kashmir Affiliated to University of Kashmir, India.'}, {'ForeName': 'Zubair', 'Initials': 'Z', 'LastName': 'Ahmed Janbaz', 'Affiliation': 'House Surgeon OMFS, IGGDC, Jammu, India.'}, {'ForeName': 'Mehnaz', 'Initials': 'M', 'LastName': 'Bibi', 'Affiliation': 'House Surgeon OMFS, IGGDC, Jammu, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Kour', 'Affiliation': 'House Surgeon OMFS, IGGDC, Jammu, India.'}]",Journal of oral biology and craniofacial research,['10.1016/j.jobcr.2020.07.008']
1936,32775244,Adjuvant treatments for biliary atresia.,"The treatment of biliary atresia (BA) is predominantly surgical with firstly an attempt at restoration of bile flow from the native liver by wide excision of the obstructed, obliterated extrahepatic biliary tree to the level of the porta hepatis and a portoenterostomy using a long Roux loop-Kasai portoenterostomy (KPE). Liver transplantation is reserved for those that fail this and for those where surgery is considered futile for reasons of age or stage of disease. As the aetiology of BA remains ill-defined, so adjuvant treatment has been largely based on pragmatism, trial and error. Systematic analysis of the few randomized placebo-controlled trial data and less well-controlled cohort studies have suggested benefit from post-operative high-dose steroids and ursodeoxycholic acid (UDCA) while the benefit of long-term prophylactic antibiotics, bile acid sequestrants (e.g., colestyramine) or probiotics remains unproven. Newer modalities such as antiviral therapy (AVT), immunoglobulin, FXR agonists (e.g., obeticholic acid), ileal bile acid transporter (IBAT) antagonists (e.g., maralixibat) remain unproven. This article reviews the current evidence for the efficacy of adjuvant medical therapy in BA.",2020,"The treatment of biliary atresia (BA) is predominantly surgical with firstly an attempt at restoration of bile flow from the native liver by wide excision of the obstructed, obliterated extrahepatic biliary tree to the level of the porta hepatis and a portoenterostomy using a long Roux loop-Kasai portoenterostomy (KPE).",['biliary atresia'],"['ursodeoxycholic acid (UDCA', 'antiviral therapy (AVT), immunoglobulin, FXR agonists', 'placebo']",[],"[{'cui': 'C0005411', 'cui_str': 'Congenital biliary atresia'}]","[{'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0874041,"The treatment of biliary atresia (BA) is predominantly surgical with firstly an attempt at restoration of bile flow from the native liver by wide excision of the obstructed, obliterated extrahepatic biliary tree to the level of the porta hepatis and a portoenterostomy using a long Roux loop-Kasai portoenterostomy (KPE).","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Burns', 'Affiliation': ""Department of Paediatric Surgery, King's College Hospital, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Davenport', 'Affiliation': ""Department of Paediatric Surgery, King's College Hospital, London, UK.""}]",Translational pediatrics,['10.21037/tp.2016.10.08']
1937,32775308,"Comparison of the Effects of Povidone-Iodine 5%, Polyhexamethylene Biguanide, and Chlorhexidine as a Preoperative Antiseptic in Endophthalmitis Prophylaxis in Patients Undergoing Phacoemulsification Cataract Surgery.","Background


This study aims to compare the efficacy and toxicity of povidone-iodine (PI) 5%, polyhexamethylene biguanide (PHMB) 0.02%, and chlorhexidine 0.02% in patients undergoing phacoemulsification cataract surgery.
Materials and Methods


This single-center, randomized study was done on 330 patients who referred to Feiz hospital in Isfahan and scheduled for cataract surgery. They were assigned randomly to 1 of 3 groups of 110 eyes who received 1 drop of PI 5% in group 1, 1 drop of PHMB 0.02% in group 2 and 1 drop of chlorhexidine 0.02% in group 3. Pre-operative Cultures samples were obtained without any topical application and it was repeated 5 min after use of antiseptic solutions. Cultures were obtained from the inferior conjunctival fornix, using sterile culture swabs while avoiding contact to the eyelids and lashes.
Results


The numbers of colony-forming units (CFUs) did not differ significantly among the three groups ( P  = 0.149 and  P  = 0.260, respectively). After the intervention, CFUs numbers in the three groups were decreased with a significant difference in both blood and chocolate agars ( P  = 0.304 and  P  = 0.136, respectively). Of the 317 eyes, 108 (34.1%) showed no bacterial growth in the pre-preparation period, which was similar in the three groups.  Staphylococcus epidermidis  was the most common isolated bacteria. Conjunctival injection was significantly different among studied groups ( P  = 0.0001), five patients in iodine group had severe conjunctival injection and no one in the other group. SPE was significantly fewer in chlorhexidine group than PHMB and iodine groups ( P  = 0.0001).
Conclusion


Pretreatment with 5% Povidone-Iodine (PVI) for at least 15 min or repeated applications over 10 min is effective in the reduction of conjunctival organisms, and results in less postoperative endophthalmitis.",2020,"SPE was significantly fewer in chlorhexidine group than PHMB and iodine groups ( P  = 0.0001).
","['Patients Undergoing Phacoemulsification Cataract Surgery', '330 patients who referred to Feiz hospital in Isfahan and scheduled for cataract surgery', 'patients undergoing phacoemulsification cataract surgery']","['Povidone-Iodine (PVI', 'chlorhexidine 0.02% in group 3. Pre', 'chlorhexidine', 'Povidone-Iodine 5%, Polyhexamethylene Biguanide, and Chlorhexidine', 'povidone-iodine (PI', 'polyhexamethylene biguanide (PHMB']","['blood and chocolate agars', 'bacterial growth', 'Conjunctival injection', 'efficacy and toxicity', 'severe conjunctival injection', 'postoperative endophthalmitis', 'numbers of colony-forming units (CFUs', 'SPE', 'CFUs numbers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C4517398', 'cui_str': '0.02'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0376892', 'cui_str': 'polihexanide'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1443929', 'cui_str': 'Chocolate agar'}, {'cui': 'C0427944', 'cui_str': 'Determination of bacterial growth'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1282227', 'cui_str': 'Postoperative endophthalmitis'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0201720', 'cui_str': 'Serum protein electrophoresis'}]",330.0,0.0711455,"SPE was significantly fewer in chlorhexidine group than PHMB and iodine groups ( P  = 0.0001).
","[{'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Peyman', 'Affiliation': 'Isfahan Eye Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Hosseini', 'Affiliation': 'Isfahan Eye Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Tahmineh', 'Initials': 'T', 'LastName': 'Narimani', 'Affiliation': 'Department of Microbiology, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Advanced biomedical research,['10.4103/abr.abr_155_19']
1938,32775376,Comparison of microendoscopic discectomy and open discectomy for single-segment lumbar disc herniation.,"BACKGROUND


Lumbar disc herniation is a common disease. Endoscopic treatment may have more advantages than traditional surgery.
AIM


To compare the clinical efficacy and safety of microendoscopic discectomy (MED) and open discectomy with lamina nucleus enucleation in the treatment of single-segment lumbar intervertebral disc herniation.
METHODS


Ninety-six patients who were operated at our hospital were selected for this study. Patients with single-segment lumbar disc herniation were admitted to the hospital from March 2018 to March 2019 and were randomly divided into the observation group and the control group with 48 cases in each group. The former group underwent lumbar discectomy and the latter underwent laparotomy and nucleus pulpectomy. Surgical effects were compared between the two groups.
RESULTS


In terms of surgical indicators, the observation group had a longer operation time, shorter postoperative bedtime and hospital stay, less intraoperative blood loss, and smaller incision length than the control group ( P  < 0.05). The excellent recovery rate did not differ significantly between the observation group (93.75%) and the control group (91.67%). Visual analogue scale pain scores were significantly lower in the observation group than in the control group at 1 d, 3 d, 1 mo, and 6 mo after surgery ( P  < 0.05). The incidence of complications was significantly lower in the observation group than in the control group (6.25%  vs  22.92%,  P  < 0.05).
CONCLUSION


Both MED and open discectomy can effectively improve single-segment lumbar disc herniation, but MED is associated with less trauma, less bleeding, and a lower incidence of complications.",2020,"Visual analogue scale pain scores were significantly lower in the observation group than in the control group at 1 d, 3 d, 1 mo, and 6 mo after surgery ( P  < 0.05).","['Patients with single-segment lumbar disc herniation were admitted to the hospital from March 2018 to March 2019', 'single-segment lumbar disc herniation', 'single-segment lumbar intervertebral disc herniation', 'Ninety-six patients who were operated at our hospital were selected for this study']","['microendoscopic discectomy (MED) and open discectomy with lamina nucleus enucleation', 'lumbar discectomy and the latter underwent laparotomy and nucleus pulpectomy', 'microendoscopic discectomy and open discectomy']","['single-segment lumbar disc herniation', 'longer operation time, shorter postoperative bedtime and hospital stay, less intraoperative blood loss, and smaller incision length', 'Visual analogue scale pain scores', 'excellent recovery rate', 'incidence of complications', 'Surgical effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0242362', 'cui_str': 'Intervertebral disc prolapse'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0034102', 'cui_str': 'Pulpectomy'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",96.0,0.0210677,"Visual analogue scale pain scores were significantly lower in the observation group than in the control group at 1 d, 3 d, 1 mo, and 6 mo after surgery ( P  < 0.05).","[{'ForeName': 'Jiu-Ya', 'Initials': 'JY', 'LastName': 'Pang', 'Affiliation': 'Department of Traumatology, The Second Hospital of Tangshan, Tangshan 0630000, Hebei Province, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Tan', 'Affiliation': 'Intensive Care Unit, The Second Hospital of Tangshan, Tangshan 0630000, Hebei Province, China.'}, {'ForeName': 'Wei-Wei', 'Initials': 'WW', 'LastName': 'Chen', 'Affiliation': 'Intensive Care Unit, The Second Hospital of Tangshan, Tangshan 0630000, Hebei Province, China.'}, {'ForeName': 'Cui-Hua', 'Initials': 'CH', 'LastName': 'Li', 'Affiliation': 'Department of Nursing, The Second Hospital of Tangshan, Tangshan 0630000, Hebei Province, China. ly80222@163.com.'}, {'ForeName': 'Shu-Ping', 'Initials': 'SP', 'LastName': 'Dou', 'Affiliation': 'Department of Hand Surgery, The Second Hospital of Tangshan, Tangshan 0630000, Hebei Province, China.'}, {'ForeName': 'Jing-Ran', 'Initials': 'JR', 'LastName': 'Guo', 'Affiliation': 'Department of Spinal Surgery, The Second Hospital of Tangshan, Tangshan 0630000, Hebei Province, China.'}, {'ForeName': 'Li-Ying', 'Initials': 'LY', 'LastName': 'Zhao', 'Affiliation': 'Hospital Office, The Second Hospital of Tangshan, Tangshan 0630000, Hebei Province, China.'}]",World journal of clinical cases,['10.12998/wjcc.v8.i14.2942']
1939,32775800,Corneal Collagen Cross-Linking Using Epithelium Disruptor Instrument in Progressive Keratoconus.,"Purpose


To compare the effects of accelerated corneal collagen cross-linking (CXL) in progressive keratoconus (KCN) patients via epithelium removal and transepithelial techniques, using Daya Disruptor (Duckworth and Kent, Hertfordshire, UK).
Methods


This study is a double-blinded, randomized clinical trial. Patients with documented bilateral progressive KCN were randomized into two groups: one eye underwent epithelium removal (Group 1), and the fellow eye underwent epithelium disruption (Group 2). The primary outcomes were best corrected visual acuity (BCVA) and uncorrected visual acuity (UCVA), Scheimpflug-extracted keratometric indices, and anterior segment-optical coherence tomography-derived epithelial thickness profiles. These parameters were evaluated before and 12 months after CXL.
Results


Sixty-four eyes from 34 patients with progressive KCN (34 eyes in the epithelium-removal group and 30 eyes in the epithelium-disruption group) were included. The mean ± standard deviation (SD) of age was 23.4 ± 3.8 years in the epithelium-removal group and 23.2 ± 3.5 years in the epithelium-disruption group. The mean ± SD of the preoperative spherical equivalent (SE), front maximum keratometry (K-max), back K-max, thickness of thinnest point, and corneal apex thickness were - 2.9 ± 3.0 diopter (D) and - 3.7 ± 3.1 D ( P  = 0.183), 53.8 ± 5.15 D and 54.4 ± 5.53 D ( P  = 0.653), -6.63 ± 2.40 D and - 6.68 ± 2.48 D ( P  = 0.131), 459.2 ± 37.4 μm and 460.8 ± 32.7 μm ( P  = 0.708), 470.5 ± 37.7 μm and 469.7 ± 33.1 μm ( P  = 0.679), and 55.4 ± 4.97 μm and 54.6 ± 7.16 μm ( P  = 0.767) in the epithelium-removal and epithelium-disruption groups, respectively. The mean ± SD changes of the UCVA and BCVA 12 months after CXL were - 0.1 ± 0.11 and - 0.02 ± 0.18 and - 0.04 ± 0.12 and - 0.02 ± 0.14 in the epithelium-removal and epithelium-disruption groups, respectively. No statistically significant improvement was observed in the UCVA and BCVA between the two groups ( P  = 0.868 and  P  = 0.937, respectively). The mean ± SD changes of the SE, superior epithelial thickness, corneal apex thickness, and thickness of thinnest point 12 months after CXL were - 0.21 ± 1.1 D and + 0.32 ± 1.6 D ( P  = 0.0001), -0.08 ± 0.26 μm and + 0.03 ± 0.33 μm ( P  = 0.028), -23 ± 11 μm and - 2 ± 6 μm ( P  = 0.0001), and - 25 ± 8 μm and - 3 ± 7 μm ( P  = 0.0001) in the epithelium-removal and epithelium-disruption groups, respectively.
Conclusions


This study showed that the epithelium-disruption CXL using Daya has a similar potential for halting KCN progression as the epithelium-removal CXL. However, regarding the 12-month changes, the epithelium-disruption CXL is superior to the epithelium-removal CXL in the SE and corneal pachymetry.",2020,"No statistically significant improvement was observed in the UCVA and BCVA between the two groups ( P  = 0.868 and  P  = 0.937, respectively).","['Patients with documented bilateral progressive KCN', 'progressive keratoconus (KCN) patients via epithelium removal and transepithelial techniques, using Daya Disruptor (Duckworth and Kent, Hertfordshire, UK', 'Sixty-four eyes from 34 patients with progressive KCN (34 eyes in the epithelium-removal group and 30 eyes in the epithelium-disruption group) were included', 'Progressive Keratoconus', 'of age was 23.4 ± 3.8 years in the epithelium-removal group and 23.2 ± 3.5 years in the epithelium-disruption group']","['epithelium removal (Group 1), and the fellow eye underwent epithelium disruption', 'accelerated corneal collagen cross-linking (CXL', 'Corneal Collagen Cross-Linking Using Epithelium Disruptor Instrument']","['mean ± standard deviation (SD', 'mean ± SD changes of the SE, superior epithelial thickness, corneal apex thickness, and thickness of thinnest point 12 months', 'corrected visual acuity (BCVA) and uncorrected visual acuity (UCVA), Scheimpflug-extracted keratometric indices, and anterior segment-optical coherence tomography-derived epithelial thickness profiles', 'mean ± SD of the preoperative spherical equivalent (SE), front maximum keratometry (K-max), back K-max, thickness of thinnest point, and corneal apex thickness', 'mean ± SD changes', 'UCVA and BCVA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C0014609', 'cui_str': 'Epithelium'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0454861', 'cui_str': 'Kent'}, {'cui': 'C0454859', 'cui_str': 'Hertfordshire'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3844010', 'cui_str': '3.5'}]","[{'cui': 'C0014609', 'cui_str': 'Epithelium'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1637380', 'cui_str': 'Uncorrected visual acuity'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0430885', 'cui_str': 'Keratometry'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",34.0,0.047375,"No statistically significant improvement was observed in the UCVA and BCVA between the two groups ( P  = 0.868 and  P  = 0.937, respectively).","[{'ForeName': 'Seyed Mohammad Salar', 'Initials': 'SMS', 'LastName': 'Zaheryani', 'Affiliation': 'Poostchi Ophthalmology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Movahedan', 'Affiliation': 'Poostchi Ophthalmology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Salouti', 'Affiliation': 'Poostchi Ophthalmology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Mohaghegh', 'Affiliation': 'Department of Optometry, School of Rehabilitation, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Javadpour', 'Affiliation': 'Department of Cardiology, Deputy of Health, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Shirvani', 'Affiliation': 'Poostchi Ophthalmology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Kasraei', 'Affiliation': 'Poostchi Ophthalmology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Bamdad', 'Affiliation': 'Poostchi Ophthalmology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Journal of current ophthalmology,['10.4103/JOCO.JOCO_59_20']
1940,32775820,A Randomized Prospective Study Comparing Anti-T-Lymphocyte Igs to Basiliximab in Highly Sensitized Kidney Transplant Patients.,"Background


Two prospective studies that were performed before the era of highly sensitive solid-phase assays have shown a lower incidence of acute rejection in highly sensitized kidney-transplant patients given polyclonal antibodies compared with those given anti-CD25 monoclonal antibodies.
Methods


This prospective pilot randomized French multicenter study aimed to compare anti-T-lymphocyte Ig (ATLG) ( n  = 32) and basiliximab ( n  = 27) in highly sensitized kidney-transplant patients without preformed donor-specific antibodies (pDSAs) as assessed by a Luminex Single-Antigen flow bead assay. Only patients with a calculated panel reactive antibody ≥50%, with at least 1 antibody with a mean fluorescence intensity ≥5000 and without a historical pDSA and without a pDSA on the day of transplantation were included.
Results


Treatment failure as defined by biopsy-proven acute rejection, patient lost to follow-up, graft loss, and death was observed in 18.8% (95% confidence interval [CI], 8.9%-37.1%) and 18.8% (95% CI, 8.9%-37.1%) in patients who received ATLG and 14.8% (95% CI, 5.8%-34.8%) and 28.2% (95% CI, 14.2%-51.2%) of patients who received basiliximab, respectively at 6 ( P  = 0.66) and 12 ( P  = 0.62) months post-transplantation. One T cell-mediated rejection was observed in ATLG-treated patients (3.1%). One antibody-mediated rejection due to a  de novo  donor-specific antibody (DSA) occurred in basiliximab-treated patients (3.7%). Patient survival, graft survival, kidney parameters, and infection rate were similar in the 2 groups.
Conclusion


This pilot study indicates that in highly sensitized kidney-transplant patients without pDSAs, both ATLG and basiliximab can be used efficiently and safely. However, because of the lack of power, these results should be interpreted with caution.",2020,"Patient survival, graft survival, kidney parameters, and infection rate were similar in the 2 groups.
","['Only patients with a calculated panel reactive antibody\xa0≥50%, with at least 1 antibody with a mean fluorescence intensity\xa0≥5000 and without a historical pDSA and without a pDSA on the day of transplantation were included', 'highly sensitized kidney-transplant patients without pDSAs, both', 'Highly Sensitized Kidney Transplant Patients']","['ATLG and basiliximab', 'Anti-T-Lymphocyte Igs to Basiliximab', 'anti-T-lymphocyte Ig (ATLG) ( n \xa0= 32) and basiliximab', 'sensitized kidney-transplant patients without preformed donor-specific antibodies (pDSAs']","['Patient survival, graft survival, kidney parameters, and infection rate', 'One T cell-mediated rejection', 'biopsy-proven acute rejection, patient lost to follow-up, graft loss, and death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1141951', 'cui_str': 'Panel-reactive antibody'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C0076533', 'cui_str': 'Thomsen-Friedenreich antibodies'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0676831', 'cui_str': 'basiliximab'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.051888,"Patient survival, graft survival, kidney parameters, and infection rate were similar in the 2 groups.
","[{'ForeName': 'Nassim', 'Initials': 'N', 'LastName': 'Kamar', 'Affiliation': 'Department of Nephrology, Dialysis and Organ Transplantation, CHU Rangueil, INSERM U1043, IFR-BMT, University Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Lepage', 'Affiliation': 'Department of Epidemiology, USMR, Toulouse, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Couzi', 'Affiliation': 'Department of Nephrology, Transplantation, Dialysis and Apheresis, CHU Bordeaux, CNRS-UMR 5164 Immuno ConcEpT Université de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Albano', 'Affiliation': 'Department of Nephrology and Transplantation, CHU Nice, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Durrbach', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, Henri Mondor Hospital, Assistance Publique-Hôpitaux de Paris, University Paris Sud, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Pernin', 'Affiliation': 'Department of Nephrology and Transplantation, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Esposito', 'Affiliation': 'Department of Nephrology, Dialysis and Organ Transplantation, CHU Rangueil, INSERM U1043, IFR-BMT, University Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Anne Laure', 'Initials': 'AL', 'LastName': 'Hebral', 'Affiliation': 'Department of Nephrology, Dialysis and Organ Transplantation, CHU Rangueil, INSERM U1043, IFR-BMT, University Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Darres', 'Affiliation': 'Department of Nephrology, Dialysis and Organ Transplantation, CHU Rangueil, INSERM U1043, IFR-BMT, University Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Moglie', 'Initials': 'M', 'LastName': 'Lequintrec', 'Affiliation': 'Department of Nephrology and Transplantation, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Cassuto', 'Affiliation': 'Department of Nephrology and Transplantation, CHU Nice, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Merville', 'Affiliation': 'Department of Nephrology, Transplantation, Dialysis and Apheresis, CHU Bordeaux, CNRS-UMR 5164 Immuno ConcEpT Université de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Congy', 'Affiliation': 'Department of Immunology, CHU Rangueil, University Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Del Bello', 'Affiliation': 'Department of Nephrology, Dialysis and Organ Transplantation, CHU Rangueil, INSERM U1043, IFR-BMT, University Paul Sabatier, Toulouse, France.'}]",Kidney international reports,['10.1016/j.ekir.2020.05.020']
1941,31823135,Long-term analyses of spastic muscle behavior in chronic poststroke patients after near-infrared low-level laser therapy (808 nm): a double-blinded placebo-controlled clinical trial.,"Stroke results in impairment of basic motor functions, such as muscle weakness in limbs affected by spasticity, leading to peripheral fatigue and impaired functionality. The clinical use of photobiomodulation therapy (PBMT) has provided major advances in the treatment of muscular disorders and prevention of muscle fatigue. The aim of this study was to analyze the effects of two distinct therapies in biceps spasticity of chronic hemiparetic patients. We analyzed range of elbow motion, torque, electromyography, and mean spectral frequency after 10 sessions of PBMT (Laser 100 mW, 808 nm, 159.24 J/cm 2 /point, 5 J/point); PBMT active or placebo was associated with exoskeleton-assisted functional treatment. A double-blind placebo-controlled sequential clinical trial was conducted with 12 healthy volunteers and 15 poststroke patients who presented upper-limb spasticity. The healthy volunteers performed only the evaluation protocol, and the poststroke volunteers participated in three consecutive phases (PBMT, PBMT + exoskeleton, placebo + PBMT) with a washout period of 4 weeks between each phase. We could observe significant increases in range of elbow motion after PBMT from 57.7 ± 14 to 84.3 ± 27.6 degrees (p < 0.001). The root mean square (RMS) values also increased after PBMT + exoskeleton from 23.2 ± 15 to 34.9 ± 21 μV (p = 0.0178). Our results suggest that the application of PBMT may contribute to an increased range of elbow motion and muscle fiber recruitment, increases in muscle strength, and, hence, to increase signal conduction on spastic muscle fibers in spastic patients.",2020,The clinical use of photobiomodulation therapy (PBMT) has provided major advances in the treatment of muscular disorders and prevention of muscle fatigue.,"['spastic patients', 'chronic hemiparetic patients', 'healthy volunteers performed only the evaluation protocol, and the poststroke volunteers participated in three', 'chronic poststroke patients after', '12 healthy volunteers and 15 poststroke patients who presented upper-limb spasticity']","['placebo', 'photobiomodulation therapy (PBMT', 'PBMT ', 'near-infrared low-level laser therapy', 'consecutive phases (PBMT, PBMT + exoskeleton, placebo + PBMT', 'PBMT active or placebo']","['range of elbow motion', 'root mean square (RMS) values', 'elbow motion, torque, electromyography, and mean spectral frequency']","[{'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1273957', 'cui_str': 'Upper limb spasticity'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",12.0,0.12055,The clinical use of photobiomodulation therapy (PBMT) has provided major advances in the treatment of muscular disorders and prevention of muscle fatigue.,"[{'ForeName': 'Marcele Florêncio', 'Initials': 'MF', 'LastName': 'das Neves', 'Affiliation': 'Laboratório de Engenharia de Reabilitação Sensório Motora, Faculdade de Ciências da Saúde, Universidade do Vale do Paraíba, São José dos Campos, SP, Brasil.'}, {'ForeName': 'Diane Cristina', 'Initials': 'DC', 'LastName': 'Aleixo', 'Affiliation': 'Laboratório de Engenharia de Reabilitação Sensório Motora, Faculdade de Ciências da Saúde, Universidade do Vale do Paraíba, São José dos Campos, SP, Brasil.'}, {'ForeName': 'Izabela Santos', 'Initials': 'IS', 'LastName': 'Mendes', 'Affiliation': 'Laboratório de Engenharia de Reabilitação Sensório Motora, Faculdade de Ciências da Saúde, Universidade do Vale do Paraíba, São José dos Campos, SP, Brasil.'}, {'ForeName': 'Fernanda Púpio Silva', 'Initials': 'FPS', 'LastName': 'Lima', 'Affiliation': 'Laboratório de Engenharia de Reabilitação Sensório Motora, Faculdade de Ciências da Saúde, Universidade do Vale do Paraíba, São José dos Campos, SP, Brasil.'}, {'ForeName': 'Renata Amadei', 'Initials': 'RA', 'LastName': 'Nicolau', 'Affiliation': 'Laboratório de Terapia Fotodinâmica - Instituto de Pesquisa & Desenvolvimento, Universidade do Vale do Paraíba, São José dos Campos, SP, Brasil.'}, {'ForeName': 'Emilia Angela Loschiavo', 'Initials': 'EAL', 'LastName': 'Arisawa', 'Affiliation': 'Laboratório de Imunologia - Instituto de Pesquisa e Desenvolvimento, Universidade do Vale do Paraíba, São José dos Campos, SP, Brasil.'}, {'ForeName': 'Rodrigo Alvaro Brandão', 'Initials': 'RAB', 'LastName': 'Lopes-Martins', 'Affiliation': 'Laboratório de Biofotônica e Terapêutica Experimental - Instituto de Pesquisa & Desenvolvimento, Universidade do Vale do Paraíba, São José dos Campos, SP, Brasil. ralopesmartins@gmail.com.'}, {'ForeName': 'Mário Oliveira', 'Initials': 'MO', 'LastName': 'Lima', 'Affiliation': 'Laboratório de Engenharia de Reabilitação Sensório Motora, Faculdade de Ciências da Saúde, Universidade do Vale do Paraíba, São José dos Campos, SP, Brasil.'}]",Lasers in medical science,['10.1007/s10103-019-02920-3']
1942,31829943,Outcomes of stent optimisation in intravascular ultrasound-guided interventions for long lesions or chronic total occlusions.,"AIMS


We sought to investigate the incidence, predictors, and clinical outcomes of stent optimisation with intravascular ultrasound (IVUS) in long coronary lesions treated with new-generation drug-eluting stents (DESs).
METHODS AND RESULTS


From four randomised trials comparing IVUS and angiography guidance in long (≥26 mm) or chronic total occlusion coronary lesions, a total of 1,396 patients who underwent IVUS-guided intervention were classified into two groups (stent optimisation and non-optimisation) according to optimisation criteria (minimal stent area [MSA] ≥5.5 mm2 or 80% of mean reference lumen area [MLA]). Major adverse cardiac event (MACE) occurrence, defined as a composite of cardiac death, myocardial infarction, stent thrombosis, or target vessel revascularisation, was compared. Stent optimisation was not met in 578 (41%) patients. Predictors of non-optimisation were older age, longer lesion length, and smaller stent diameter. The MACE rate was significantly higher in the non-optimisation versus the stent optimisation group (4.8% vs 1.9%, log-rank p=0.002; adjusted hazard ratio 2.95, 95% CI: 1.43-6.06). Among possible combinations of absolute and relative expansion criteria, the one best predicting MACE was at least one of MSA ≥5.4 mm2 and/or ≥80% of MLA (Youden index=0.264).
CONCLUSIONS


Achieving stent optimisation using IVUS evaluation was associated with favourable outcomes in IVUS-guided, new-generation DES implantation for long coronary lesions including CTOs.",2020,"Achieving stent optimisation using IVUS evaluation was associated with favourable outcomes in IVUS-guided, new-generation DES implantation for long coronary lesions including CTOs.","['long lesions or chronic total occlusions', 'in long (≥26 mm) or chronic total occlusion coronary lesions, a total of 1,396 patients who underwent IVUS-guided intervention']","['new-generation drug-eluting stents (DESs', 'intravascular ultrasound-guided interventions', 'stent optimisation with intravascular ultrasound (IVUS', 'IVUS and angiography guidance']","['MACE rate', 'Major adverse cardiac event (MACE) occurrence, defined as a composite of cardiac death, myocardial infarction, stent thrombosis, or target vessel revascularisation']","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0151814', 'cui_str': 'Coronary occlusion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",1396.0,0.0527222,"Achieving stent optimisation using IVUS evaluation was associated with favourable outcomes in IVUS-guided, new-generation DES implantation for long coronary lesions including CTOs.","[{'ForeName': 'Daehoon', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sung-Jin', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': ''}, {'ForeName': 'Byeong-Keuk', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Dong-Ho', 'Initials': 'DH', 'LastName': 'Shin', 'Affiliation': ''}, {'ForeName': 'Chul-Min', 'Initials': 'CM', 'LastName': 'Ahn', 'Affiliation': ''}, {'ForeName': 'Jung-Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Young-Guk', 'Initials': 'YG', 'LastName': 'Ko', 'Affiliation': ''}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'Myeong-Ki', 'Initials': 'MK', 'LastName': 'Hong', 'Affiliation': ''}, {'ForeName': 'Yangsoo', 'Initials': 'Y', 'LastName': 'Jang', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-00762']
1943,32768635,Bidirectional effects between expressive regulatory abilities and peer acceptance among Chinese adolescents.,"The current study examined potential bidirectional effects between adolescents' expressive regulation (the ability to enhance and suppress overt emotional behavior in line with situational demands) and peer interactions via two experiments. Experiment 1 tested the hypothesis that adolescents' expressive regulation affects their social acceptance from peers. Participants (N = 147) were randomly divided into three conditions and watched video clips in which a same-sex partner differed in his or her levels of expressive enhancement and suppression abilities. Results showed that participants reported greater liking of the partner when he or she was able to flexibly enhance and suppress emotional expressions in line with situational demands compared with when either one of these abilities was impaired. Experiment 2 then examined whether peer rejection reduced participants' enhancement and suppression abilities. We manipulated participants' feelings of rejection through a virtual Cyberball game. Following this manipulation (N = 100; Inclusion vs. Exclusion), we tested participants' expressive enhancement and suppression abilities, as well as their natural expressivity, via an observational task. Peer exclusion resulted in lower levels of enhancement ability and natural expressive behaviors but did not impair suppression ability. The results of these experiments suggest that both expressive enhancement and expressive suppression are important for adolescents to obtain higher peer acceptance. In addition, peer exclusion also caused impairments in expressive regulation, specifically reduced enhancement abilities. In summary, these results evidenced the bidirectional effects between expressive regulation and peer acceptance.",2020,Peer exclusion resulted in lower levels of enhancement ability and natural expressive behaviors but did not impair suppression ability.,"['Chinese adolescents', 'Participants (N\xa0=\xa0147']",['watched video clips'],"['enhancement ability and natural expressive behaviors', 'enhancement abilities', 'emotional expressions']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0175722', 'cui_str': 'Clip'}]","[{'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",147.0,0.0275084,Peer exclusion resulted in lower levels of enhancement ability and natural expressive behaviors but did not impair suppression ability.,"[{'ForeName': 'Yingqian', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Psychology, School of Sociology and Psychology, Central University of Finance and Economics, Beijing 100081, China; Department of Educational Psychology, The Chinese University of Hong Kong, Shatin, NT, Hong Kong, China. Electronic address: wangyingqian@link.cuhk.edu.hk.'}, {'ForeName': 'Skyler T', 'Initials': 'ST', 'LastName': 'Hawk', 'Affiliation': 'Department of Educational Psychology, The Chinese University of Hong Kong, Shatin, NT, Hong Kong, China.'}, {'ForeName': 'Wenqing', 'Initials': 'W', 'LastName': 'Zong', 'Affiliation': 'Department of Educational Psychology, The Chinese University of Hong Kong, Shatin, NT, Hong Kong, China.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2020.104891']
1944,32769506,Oral fluid intake during the first stage of labour: A randomised trial.,"BACKGROUND


Obstetric anaesthesia has been associated with concern for the inhalation of gastric contents for many years, justifying fasting during labour. However, many anaesthesiologists and obstetricians now allow fluid intake during labour.
OBJECTIVE(S)


We hypothesised that allowing oral fluid intake during labour is not associated with increased gastric contents. We used ultrasound assessment of gastric contents to evaluate this hypothesis.
DESIGN


A randomised, single-blind and intention-to-treat noninferiority trial comparing antral area measured by ultrasound in fasting parturients and in those who were allowed to drink fluid for 90 min after randomisation.
SETTING


Tenon University Hospital, Assistance Publique Hôpitaux de Paris, Paris, France.
PATIENTS


Pregnant women, aged from 18 to 40 years and from week 36 of an uncomplicated singleton gestation, were randomised into a fasting group and a fluid intake group after admission to the delivery room. Of the 184 patients screened, data from 125 were analysed: fasting group (62), fluid intake group (63).
INTERVENTION


Women in the fluid intake group were allowed to drink up to 400 ml of apple juice for 90 min after randomisation.
MAIN OUTCOME MEASURE


We compared the percentage of women with an 'empty stomach' between the two groups: empty stomach was defined as an antral cross-sectional area (CSA) less than 300 mm assessed in a semirecumbent position with a 45-degree head-up tilt.
RESULTS


At full cervical dilatation an antral CSA less than 300 mm was measured in 76 and 79% of the parturients in the fasting group and the fluid intake groups respectively (P = 0.633).
CONCLUSION


The current study reveals that the percentage of pregnant women with an 'empty stomach', defined by an antral CSA less than 300 mm in a semirecumbent position with a 45-degree head-up tilt, was comparable at full cervical dilation among those who remained nil by mouth and those allowed to drink up to 400 ml for 90 min after their randomisation.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT02362815.",2020,"At full cervical dilatation an antral CSA less than 300 mm was measured in 76 and 79% of the parturients in the fasting group and the fluid intake groups respectively (P = 0.633).
","['184 patients screened, data from 125 were analysed: fasting group (62), fluid intake group (63', 'Tenon University Hospital, Assistance Publique Hôpitaux de Paris, Paris, France', ""pregnant women with an 'empty stomach"", 'Pregnant women, aged from 18 to 40 years and from week 36 of an uncomplicated singleton gestation', ""women with an 'empty stomach' between the two groups: empty stomach was defined as an antral cross-sectional area (CSA) less than 300\u200amm assessed in a semirecumbent position with a 45-degree head-up tilt"", 'first stage of labour', 'fasting parturients and in those who were allowed to drink fluid for 90\u200amin after randomisation']","['fasting group and a fluid intake group after admission to the delivery room', 'drink up to 400\u200aml of apple juice']",['Oral fluid intake'],"[{'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0030561', 'cui_str': 'Paris'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1293898', 'cui_str': 'Head up'}, {'cui': 'C0022871', 'cui_str': 'First stage of labor'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011212', 'cui_str': 'Delivery suite'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0452454', 'cui_str': 'Apple juice'}]","[{'cui': 'C0429648', 'cui_str': 'Quantity of drinking'}]",,0.217113,"At full cervical dilatation an antral CSA less than 300 mm was measured in 76 and 79% of the parturients in the fasting group and the fluid intake groups respectively (P = 0.633).
","[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Rousset', 'Affiliation': 'From the Department of Anaesthesiology and Perioperative Medicine, Hôpital Tenon (JR, SC, FT, JB, EMH, CQ, FB), Biostatistics Department, Hôpital Saint Louis-Lariboisière, Assistance Publique Hôpitaux de Paris (EF), Faculty of Medicine Paris VI, Sorbonne University (CQ, FB) and Department of Anaesthesiology, Hôpital Foch, Paris, France (MF).'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Clariot', 'Affiliation': ''}, {'ForeName': 'Félix', 'Initials': 'F', 'LastName': 'Tounou', 'Affiliation': ''}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Burey', 'Affiliation': ''}, {'ForeName': 'El M', 'Initials': 'EM', 'LastName': 'Hafiani', 'Affiliation': ''}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Féliot', 'Affiliation': ''}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Quesnel', 'Affiliation': ''}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Bonnet', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Fischler', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001278']
1945,32769511,"Clinical effectiveness of ultrasound-guided dual transversus abdominis plane block for postoperative analgesia in open abdominal aortic surgery patients: The randomised, double-blind ETAP trial.",,2020,,['open abdominal aortic surgery patients'],['ultrasound-guided dual transversus abdominis plane block'],[],"[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0877130', 'cui_str': 'Aortic surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]",[],,0.615371,,"[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Chenet', 'Affiliation': 'From the Department of Anaesthesiology and Intensive Care Medicine, University Hospital of Besancon (JC, ED, TL, VS, SP-F, ES, GB), EA 3920, Bourgogne Franche-Comte University (LSdM, SP-F, ES, GB), Department of Vascular Surgery (LSdM) and Clinical Methodology Center, University Hospital of Besancon, Besancon, France (MP).'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Dupont', 'Affiliation': ''}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Salomon du Mont', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Levy', 'Affiliation': ''}, {'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Salignon', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Puyraveau', 'Affiliation': ''}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Pili-Floury', 'Affiliation': ''}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Samain', 'Affiliation': ''}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Besch', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001240']
1946,32769515,Efficacy of incisional infiltration and intraperitoneal instillation of ropivacaine for the management of pain after laparoscopic sleeve gastrectomy: A randomised clinical trial.,,2020,,['pain after laparoscopic sleeve gastrectomy'],['incisional infiltration and intraperitoneal instillation of ropivacaine'],[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]",[],,0.0516737,,"[{'ForeName': 'Leonidas', 'Initials': 'L', 'LastName': 'Alevizos', 'Affiliation': 'From the 1st Department of Propaedeutic Surgery, Hippokration General Hospital, Athens Medical School, Athens, Greece (LA, VK, KA, EM, GZ, EL) and Department of Anaesthesiology and Pain Management, American Medical Centre, Nicosia, Cyprus (PZ).'}, {'ForeName': 'Periklis', 'Initials': 'P', 'LastName': 'Zavridis', 'Affiliation': ''}, {'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Kalles', 'Affiliation': ''}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Albanopoulos', 'Affiliation': ''}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Menenakos', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Zografos', 'Affiliation': ''}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Leandros', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001206']
1947,32769596,"Focused Shockwave Treatment for Greater Trochanteric Pain Syndrome: A Multicenter, Randomized, Controlled Clinical Trial.","BACKGROUND


Greater trochanteric pain syndrome (GTPS) is a condition of lateral hip pain. Its physiopathology remains unknown, and there is no consensus on optimal management. The aim of this study was to assess the effectiveness of electromagnetic-focused extracorporeal shockwave treatment (F-ESWT) in patients with GTPS.
METHODS


This multicenter clinical trial included 103 patients with chronic GTPS randomly assigned to the treatment group, consisting of electromagnetic F-ESWT and a specific exercise protocol, or the control group, receiving sham F-ESWT and the same exercise protocol. Both groups were treated with 3 weekly sessions; the F-ESWT group received an energy flux density of 0.20 mJ/mm, whereas the control group received 0.01 mJ/mm. Patients were assessed at baseline and 1, 2, 3, and 6 months after treatment. A visual analogue scale (VAS) score for pain at 2 months was the primary outcome. The Harris hip score (HHS), Lower Extremity Functional Scale (LEFS), EuroQoL-5 Dimensions Questionnaire (EQ-5D), and Roles and Maudsley score were used as secondary outcomes. Complications were recorded.
RESULTS


The mean VAS score decreased from 6.3 at baseline in both groups to 2.0 in the F-ESWT group versus 4.7 in the control group at 2 months; the 2-month score differed significantly between groups (p < 0.001). All secondary outcomes at all follow-up intervals were significantly better in the F-ESWT group, except for the LEFS score at 1 month after treatment (p = 0.25). No complications were observed.
CONCLUSIONS


F-ESWT in association with a specific exercise program is safe and effective for GTPS, with a success rate of 86.8% at 2 months after treatment, which was maintained until the end of follow-up.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,The mean VAS score decreased from 6.3 at baseline in both groups to 2.0 in the F-ESWT group versus 4.7 in the control group at 2 months; the 2-month score differed significantly between groups (p < 0.001).,"['patients with GTPS', '103 patients with chronic GTPS', 'Greater Trochanteric Pain Syndrome']","['Shockwave Treatment', 'electromagnetic F-ESWT and a specific exercise protocol, or the control group, receiving sham F-ESWT and the same exercise protocol', 'electromagnetic-focused extracorporeal shockwave treatment (F-ESWT']","['mean VAS score', 'visual analogue scale (VAS) score for pain', 'LEFS score', 'Harris hip score (HHS), Lower Extremity Functional Scale (LEFS), EuroQoL-5 Dimensions Questionnaire (EQ-5D), and Roles and Maudsley score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0391976', 'cui_str': 'Pain Disorder'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013838', 'cui_str': 'Electromagnetics'}, {'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4305124', 'cui_str': 'Lower Extremity Functional Scale score'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C4305121', 'cui_str': 'Lower Extremity Functional Scale'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035820', 'cui_str': 'Role'}]",103.0,0.126826,The mean VAS score decreased from 6.3 at baseline in both groups to 2.0 in the F-ESWT group versus 4.7 in the control group at 2 months; the 2-month score differed significantly between groups (p < 0.001).,"[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ramon', 'Affiliation': 'Department of Physical Medicine and Rehabilitation (PMR) (S. Ramon and R.d.U.) and Department of Orthopedic Surgery, Instituto Cugat (R.C. and R.S.), Quirónsalud Hospital, Barcelona, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Russo', 'Affiliation': 'Department of Public Health, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Santoboni', 'Affiliation': 'Physical Medicine and Rehabilitation (F.S., M.V., R.B., G.S., S.-M.N., and M.-C.V.), and Department of Statistics (R.B.), Sapienza University School of Medicine, Rome, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Lucenteforte', 'Affiliation': 'Policlinico Vittorio Emanuele, Università degli Studi di Catania, Catania. Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Di Luise', 'Affiliation': 'Department of Public Health, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'de Unzurrunzaga', 'Affiliation': 'Department of Physical Medicine and Rehabilitation (PMR) (S. Ramon and R.d.U.) and Department of Orthopedic Surgery, Instituto Cugat (R.C. and R.S.), Quirónsalud Hospital, Barcelona, Spain.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Vetrano', 'Affiliation': 'Physical Medicine and Rehabilitation (F.S., M.V., R.B., G.S., S.-M.N., and M.-C.V.), and Department of Statistics (R.B.), Sapienza University School of Medicine, Rome, Italy.'}, {'ForeName': 'Mariantonia', 'Initials': 'M', 'LastName': 'Albano', 'Affiliation': 'Department of Public Health, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Rosella', 'Initials': 'R', 'LastName': 'Baldini', 'Affiliation': 'Physical Medicine and Rehabilitation (F.S., M.V., R.B., G.S., S.-M.N., and M.-C.V.), and Department of Statistics (R.B.), Sapienza University School of Medicine, Rome, Italy.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Cugat', 'Affiliation': 'Department of Physical Medicine and Rehabilitation (PMR) (S. Ramon and R.d.U.) and Department of Orthopedic Surgery, Instituto Cugat (R.C. and R.S.), Quirónsalud Hospital, Barcelona, Spain.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Stella', 'Affiliation': 'Physical Medicine and Rehabilitation (F.S., M.V., R.B., G.S., S.-M.N., and M.-C.V.), and Department of Statistics (R.B.), Sapienza University School of Medicine, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Balato', 'Affiliation': 'Department of Public Health, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Seijas', 'Affiliation': 'Department of Physical Medicine and Rehabilitation (PMR) (S. Ramon and R.d.U.) and Department of Orthopedic Surgery, Instituto Cugat (R.C. and R.S.), Quirónsalud Hospital, Barcelona, Spain.'}, {'ForeName': 'Sveva-Maria', 'Initials': 'SM', 'LastName': 'Nusca', 'Affiliation': 'Physical Medicine and Rehabilitation (F.S., M.V., R.B., G.S., S.-M.N., and M.-C.V.), and Department of Statistics (R.B.), Sapienza University School of Medicine, Rome, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Servodidio', 'Affiliation': 'Department of Public Health, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Maria-Chiara', 'Initials': 'MC', 'LastName': 'Vulpiani', 'Affiliation': 'Physical Medicine and Rehabilitation (F.S., M.V., R.B., G.S., S.-M.N., and M.-C.V.), and Department of Statistics (R.B.), Sapienza University School of Medicine, Rome, Italy.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.00093']
1948,32769754,Remote corneal suturing wet lab: Microsurgical education during the COVID-19 pandemic.,"PURPOSE


To study the feasibility and efficacy of a novel remote wet lab for microsurgical education using a corneal suturing task.
SETTING


Department of Ophthalmology, University of California San Francisco, San Francisco, California, USA.
DESIGN


Prospective randomized controlled study.
METHODS


Ten ophthalmology residents were stratified by postgraduate year and randomized to perform a corneal suturing task consisting of placing the 4 cardinal sutures for a penetrating keratoplasty in porcine eyes with or without remote ophthalmology attending feedback. Subsequently, both groups repeated the same task without remote feedback to test whether initial remote feedback affected subsequent performance. Finally, the group without feedback was crossed over to repeat the same corneal suturing task with remote feedback. The effectiveness of the remote wet lab was assessed subjectively by survey and objectively by grading each suture pass.
RESULTS


Resident-reported comfort with corneal suturing improved significantly after the remote wet lab for all residents. Residents and attendings rated the remote wet lab as equally or more effective compared to prior in-person wet labs and overall effective in corneal suturing. Attendings rated the remote wet lab as effective in multiple domains of microsurgical education using a modified microsurgical global rating scale. Objective corneal suturing performance was similar for both groups.
CONCLUSION


The remote wet lab was feasible and effective for training ophthalmology residents in corneal suturing. This represents a novel social distancing compliant platform for microsurgical education during the COVID-19 pandemic.",2020,Attendings rated the remote wet lab as effective in multiple domains of microsurgical education using a modified microsurgical global rating scale.,"['Ten ophthalmology residents', 'Department of Ophthalmology, University of California San Francisco, San Francisco, California, USA']","['Remote corneal suturing wet lab', 'corneal suturing task consisting of placing the 4 cardinal sutures for a penetrating keratoplasty in porcine eyes with or without remote ophthalmology attending feedback', 'novel remote wet lab for microsurgical education']","['comfort with corneal suturing', 'Objective corneal suturing performance']","[{'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0326926', 'cui_str': 'Cardinalis cardinalis'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0022592', 'cui_str': 'Penetrating keratoplasty'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}]",,0.0200271,Attendings rated the remote wet lab as effective in multiple domains of microsurgical education using a modified microsurgical global rating scale.,"[{'ForeName': 'Neel D', 'Initials': 'ND', 'LastName': 'Pasricha', 'Affiliation': 'From the Department of Ophthalmology (Pasricha, Haq, Chan, Redd, Seitzman, Parikh, Kim, Schallhorn, Ramanathan), School of Medicine (Ahmad), and Francis I. Proctor Foundation (Redd, Seitzman, Schallhorn), University of California San Francisco, San Francisco, California, USA. Supported in part by a Research to Prevent Blindness unrestricted grant to the University of California San Francisco, Department of Ophthalmology.'}, {'ForeName': 'Zeeshan', 'Initials': 'Z', 'LastName': 'Haq', 'Affiliation': ''}, {'ForeName': 'Tessnim R', 'Initials': 'TR', 'LastName': 'Ahmad', 'Affiliation': ''}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'Travis K', 'Initials': 'TK', 'LastName': 'Redd', 'Affiliation': ''}, {'ForeName': 'Gerami D', 'Initials': 'GD', 'LastName': 'Seitzman', 'Affiliation': ''}, {'ForeName': 'Neeti', 'Initials': 'N', 'LastName': 'Parikh', 'Affiliation': ''}, {'ForeName': 'Tyson N', 'Initials': 'TN', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Schallhorn', 'Affiliation': ''}, {'ForeName': 'Saras', 'Initials': 'S', 'LastName': 'Ramanathan', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000374']
1949,32769849,"SUPPORT-1 (Subjects Undergoing PCI and Perioperative Reperfusion Treatment): A Prospective, Randomized Trial of CMX-2043 in Patients Undergoing Elective Percutaneous Coronary Intervention.","OBJECTIVE


The natural molecule α-lipoic acid has been shown to be partially cytoprotective through antioxidant and antiapoptotic mechanisms. To obtain an initial assessment of the safety and potential efficacy of a synthetic derivative, CMX-2043, in preventing ischemic complications of percutaneous coronary intervention (PCI) we conducted the Subjects Undergoing PCI and Perioperative Reperfusion Treatment (SUPPORT-1) trial, the first patient experience with this agent.
METHODS AND RESULTS


SUPPORT-1 was a phase 2a, 6-center, international, placebo-controlled, randomized, double-blind trial. A total of 142 patients were randomized to receive a single intravenous bolus dose of drug or placebo administered 15-60 minutes before PCI. Cardiac biomarker assessments included serial measurements of creatine kinase myocardial band (CK-MB) at 6, 12, 18, and 24 hours after PCI and a single measurement of troponin T (TnT) at 24 hours. Peak concentrations of CK-MB and TnT were significantly reduced in the 2.4 mg/kg group compared with placebo (P = 0.05 and 0.03, respectively). No subject administered 2.4 mg/kg of CMX-2043 had an increase of CK-MB to ≥3X upper limit of normal versus 16% for placebo (P = 0.02); 16% of the 2.4-mg/kg dose group developed an elevation of TnT to ≥3X upper limit of normal versus 39% in the placebo group (P = 0.05). No drug-related serious adverse events were observed in any group.
CONCLUSION


These data suggest that CMX-2043 may reduce PCI periprocedural myonecrosis and support further clinical evaluation of this novel agent for its potential cytoprotective effects.",2020,"Peak concentrations of CK-MB and TnT were significantly reduced in the 2.4 mg/kg group compared with placebo (P = 0.05 and 0.03, respectively).","['SUPPORT-1 (Subjects Undergoing PCI and Perioperative Reperfusion Treatment', 'Patients Undergoing Elective Percutaneous Coronary Intervention', 'Subjects Undergoing PCI and Perioperative Reperfusion Treatment (SUPPORT-1) trial, the first patient experience with this agent', '142 patients']","['percutaneous coronary intervention (PCI', 'synthetic derivative, CMX-2043', 'CMX-2043', 'placebo']","['Peak concentrations of CK-MB and TnT', 'CK-MB', 'elevation of TnT to ≥3X upper limit of normal', 'serious adverse events']","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C4079957', 'cui_str': 'CMX-2043'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",142.0,0.53467,"Peak concentrations of CK-MB and TnT were significantly reduced in the 2.4 mg/kg group compared with placebo (P = 0.05 and 0.03, respectively).","[{'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Tcheng', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gibson', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Mitchell W', 'Initials': 'MW', 'LastName': 'Krucoff', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Manesh R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Mullasari', 'Initials': 'M', 'LastName': 'Ajit', 'Affiliation': 'Madras Medical Mission, Chennai, India.'}, {'ForeName': 'Jagdish', 'Initials': 'J', 'LastName': 'Hiremath', 'Affiliation': 'Poona Hospital and Research Centre, Pune, India.'}, {'ForeName': 'Chandrashekhar', 'Initials': 'C', 'LastName': 'Ponde', 'Affiliation': 'P. D. Hinduja National Hospital & Medical Research Centre, Mumbai, India.'}, {'ForeName': 'Eddison', 'Initials': 'E', 'LastName': 'Ramsaran', 'Affiliation': 'Department of Interventional Cardiology, Reliant Medical Group, Worcester, MA.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Clark', 'Affiliation': 'Ischemix, Inc, Maynard, MA.'}, {'ForeName': 'Alan S', 'Initials': 'AS', 'LastName': 'Lader', 'Affiliation': 'Ischemix, Inc, Maynard, MA.'}, {'ForeName': 'Reinier', 'Initials': 'R', 'LastName': 'Beeuwkes', 'Affiliation': 'Ischemix, Inc, Maynard, MA.'}]",Journal of cardiovascular pharmacology,['10.1097/FJC.0000000000000830']
1950,32769863,Long-term beneficial effects of an online mind-body training program on stress and psychological outcomes in female healthcare providers: A non-randomized controlled study.,"Mind-body training (MBT) programs are effective interventions for relieving stress and improving psychological capabilities. To expand our previous study which demonstrated the short-term effects of an 8-week online MBT program, the present study investigated whether those short-term effects persist up to a month after the end of the intervention.Among previous participants, 56 (64%) participated in this follow-up study, 25 in the MBT group and 31 in the control group. Outcome measures included the stress response, emotional intelligence, resilience, coping strategies, positive and negative affect, and anger expression of both groups at baseline, at 8 weeks (right after the training or waiting period), and at 12 weeks (a month after the training or waiting period).The MBT group showed a greater decrease in stress response at 8 weeks, and this reduction remained a month after the end of the intervention. The effect of MBT on resilience and effective coping strategies was also significant at 8 weeks and remained constant a month later. However, the improvement to emotional intelligence and negative affect did not persist a month after training.These findings suggest that the beneficial short-term effects of MBT may last beyond the training period even without continuous practice, but the retention of these benefits seems to depend on the outcome variables. Through a convenient, affordable, and easily accessible online format, MBT may provide cost-effective solutions for employees at worksites.",2020,The effect of MBT on resilience and effective coping strategies was also significant at 8 weeks and remained constant a month later.,['female healthcare providers'],"['MBT', 'online mind-body training program', 'Mind-body training']","['emotional intelligence', 'stress and psychological outcomes', 'stress response, emotional intelligence, resilience, coping strategies, positive and negative affect, and anger expression', 'resilience and effective coping strategies', 'stress response']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1510539', 'cui_str': 'Emotional Intelligence'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C2364069', 'cui_str': 'Able to cope'}]",,0.0207628,The effect of MBT on resilience and effective coping strategies was also significant at 8 weeks and remained constant a month later.,"[{'ForeName': 'Dasom', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Emotional Information and Communication Technology Association.'}, {'ForeName': 'Won Joon', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Kangdong Sacred Heart Hospital.'}, {'ForeName': 'Soo-Hee', 'Initials': 'SH', 'LastName': 'Choi', 'Affiliation': 'Department of Psychiatry, Seoul National University Hospital.'}, {'ForeName': 'Joon-Hwan', 'Initials': 'JH', 'LastName': 'Jang', 'Affiliation': 'Department of Psychiatry, Seoul National University Hospital.'}, {'ForeName': 'Do-Hyung', 'Initials': 'DH', 'LastName': 'Kang', 'Affiliation': 'Emotional Information and Communication Technology Association.'}]",Medicine,['10.1097/MD.0000000000021027']
1951,32769873,A phase 2 basket trial of combination therapy with trastuzumab and pertuzumab in patients with solid cancers harboring human epidermal growth factor receptor 2 amplification (JUPITER trial).,"INTRODUCTION


Human epidermal growth factor receptor 2 (HER2) gene amplification and mutations have emerged as oncogenic drivers and therapeutic targets not limited to breast and gastric cancers, but also in a variety of cancers. However, even if an actionable gene alteration is found, the incidence of HER2 amplification in these cancers is less than 5%. It is too difficult to conduct a conventional randomized, controlled trial in a rare fraction. Therefore, we have designed a organ-agnostic basket study, which covers a variety of solid cancers harboring HER2 amplification, in 1 study protocol.
METHODS/DESIGN


This trial is a multicenter, single-arm, basket phase 2 study in Japan. Patients with solid cancers harboring HER2 amplification that have progressed with standard treatment, or rare cancers for which there is no standard treatment, will be eligible. Target cancers include bile duct, urothelial, uterine, ovarian, and other solid cancers where HER2 amplification is detected by comprehensive genomic profiling using next-generation sequencing technology. A total of 38 patients will be treated with combination therapy with trastuzumab and pertuzumab every 3 weeks until disease progression, unmanageable toxicity, death, or patient refusal. The primary endpoint is the objective response rate, and secondary endpoints are progression-free survival, overall survival, and duration of response.
DISCUSSION


The aim of this trial is to evaluate the safety and efficacy of combination therapy with trastuzumab and pertuzumab in patients with locally advanced or metastatic, solid cancers harboring HER2 amplification. Instead of focusing on 1 organ type, our trial design uses a basket study focusing on HER2 amplification, regardless of the site or origin of the cancer. The results of our study will advance clinical and scientific knowledge concerning the treatment of locally advanced, rare solid cancers harboring HER2 amplification, using the combination of trastuzumab and pertuzumab.
TRIAL REGISTRATION


This trial was registered in Japan Registry of Clinical Trials (jCRT) on February 25, 2019, as jRCT2031180150.",2020,"The primary endpoint is the objective response rate, and secondary endpoints are progression-free survival, overall survival, and duration of response.
","['Japan', 'Patients with solid cancers harboring HER2 amplification that have progressed with standard treatment, or rare cancers', 'patients with locally advanced or metastatic, solid cancers harboring HER2 amplification', '38 patients will be treated with combination therapy with', 'patients with solid cancers harboring human epidermal growth factor receptor 2 amplification (JUPITER trial']",['trastuzumab and pertuzumab'],"['safety and efficacy', 'objective response rate, and secondary endpoints are progression-free survival, overall survival, and duration of response']","[{'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0242754', 'cui_str': 'Jupiter'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",38.0,0.115023,"The primary endpoint is the objective response rate, and secondary endpoints are progression-free survival, overall survival, and duration of response.
","[{'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Center for Innovative Cancer Treatment.'}, {'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Ishibashi', 'Affiliation': 'Medical Innovation Promotion Center, Tokyo Medical and Dental University, Tokyo.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Kubo', 'Affiliation': 'Department of General Thoracic Surgery and Breast and Endocrinological Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science, Okayama.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Harada', 'Affiliation': 'Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Hayashi', 'Affiliation': 'Genomics Unit, Keio Cancer Center, Keio University School of Medicine, Tokyo.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Kano', 'Affiliation': 'Department of Frontier Surgery, Chiba University, Chiba.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Shimizu', 'Affiliation': 'Department of Medical Oncology, Faculty of Medicine & Graduate School of Medicine, Hokkaido University, Hokkaido.'}, {'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Shirota', 'Affiliation': 'Department of Clinical Oncology, Tohoku University Hospital, Sendai.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Mori', 'Affiliation': 'Department of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Muto', 'Affiliation': 'Department of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto.'}, {'ForeName': 'Chikashi', 'Initials': 'C', 'LastName': 'Ishioka', 'Affiliation': 'Department of Clinical Oncology, Tohoku University Hospital, Sendai.'}, {'ForeName': 'Hirotoshi', 'Initials': 'H', 'LastName': 'Dosaka-Akita', 'Affiliation': 'Department of Medical Oncology, Faculty of Medicine & Graduate School of Medicine, Hokkaido University, Hokkaido.'}, {'ForeName': 'Hisahiro', 'Initials': 'H', 'LastName': 'Matsubara', 'Affiliation': 'Department of Frontier Surgery, Chiba University, Chiba.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nishihara', 'Affiliation': 'Genomics Unit, Keio Cancer Center, Keio University School of Medicine, Tokyo.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Sueoka-Aragane', 'Affiliation': 'Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Toyooka', 'Affiliation': 'Department of General Thoracic Surgery and Breast and Endocrinological Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science, Okayama.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Hirakawa', 'Affiliation': 'Clinical Research Center.'}, {'ForeName': 'Ukihide', 'Initials': 'U', 'LastName': 'Tateishi', 'Affiliation': 'Department of Diagnostic Radiology, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Miyake', 'Affiliation': 'Center for Innovative Cancer Treatment.'}, {'ForeName': 'Sadakatsu', 'Initials': 'S', 'LastName': 'Ikeda', 'Affiliation': 'Center for Innovative Cancer Treatment.'}]",Medicine,['10.1097/MD.0000000000021457']
1952,32769914,Effect of butylphthalide on new cerebral microbleeds in patients with acute ischemic stroke.,"BACKGROUND


To evaluate the effect of dl-3-N-butylphthalide (NBP) on new cerebral microbleeds (CMBs) in patients with acute ischemic stroke (AIS).
METHODS


We will prospectively enroll patients with AIS admitted to the stroke center of Jingjiang People's Hospital. Qualified participants will be randomly assigned to either the NBP group (NBP injection) or the control group (NBP injection placebo) in a ratio of 1:1. Patients will complete the brain magnetic resonance imaging within 48 hours and 14 days after stroke onset to observe the CMBs through susceptibility weighted imaging, and evaluate whether the use of NBP will affect the new CMBs in AIS patients. SPSS 20.0 will be used for statistical analyses.
RESULT


We will provide practical and targeted results assessing the safety of NBP for AIS patients, to provide reference for clinical use of NBP.
CONCLUSION


The stronger evidence about the effect of NBP on new CMBs in AIS patients will be provided for clinicians.",2020,Qualified participants will be randomly assigned to either the NBP group (NBP injection) or the control group (NBP injection placebo) in a ratio of 1:1.,"[""enroll patients with AIS admitted to the stroke center of Jingjiang People's Hospital"", 'patients with acute ischemic stroke (AIS', 'patients with acute ischemic stroke']","['butylphthalide', 'dl-3-N-butylphthalide (NBP', 'NBP group (NBP injection) or the control group (NBP injection placebo', 'NBP']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0047625', 'cui_str': '3-n-butylphthalide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.122005,Qualified participants will be randomly assigned to either the NBP group (NBP injection) or the control group (NBP injection placebo) in a ratio of 1:1.,"[{'ForeName': 'Yunlong', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': ""Department of Neurology, Jingjiang People's Hospital, the Seventh Affiliated Hospital of Yangzhou University, Jiangsu, China.""}, {'ForeName': 'Zhiqun', 'Initials': 'Z', 'LastName': 'Gu', 'Affiliation': ""Department of Neurology, Jingjiang People's Hospital, the Seventh Affiliated Hospital of Yangzhou University, Jiangsu, China.""}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Zhai', 'Affiliation': ""Department of Neurology, Jingjiang People's Hospital, the Seventh Affiliated Hospital of Yangzhou University, Jiangsu, China.""}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, Jingjiang People's Hospital, the Seventh Affiliated Hospital of Yangzhou University, Jiangsu, China.""}, {'ForeName': 'Yanrong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, Jingjiang People's Hospital, the Seventh Affiliated Hospital of Yangzhou University, Jiangsu, China.""}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': ""Department of Neurology, Jingjiang People's Hospital, the Seventh Affiliated Hospital of Yangzhou University, Jiangsu, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Neurology, Jingjiang People's Hospital, the Seventh Affiliated Hospital of Yangzhou University, Jiangsu, China.""}, {'ForeName': 'Jiali', 'Initials': 'J', 'LastName': 'Niu', 'Affiliation': ""Department of Clinical Pharmacy, Jingjiang People's Hospital, the Seventh Affiliated Hospital of Yangzhou University, Jiangsu, China.""}]",Medicine,['10.1097/MD.0000000000021594']
1953,32769919,"Light-emitting diode photobiomodulation therapy for non-specific low back pain in working nurses: A single-center, double-blind, prospective, randomized controlled trial.","BACKGROUND


Low back pain (LBP) affects approximately 51% to 57% of hospital nurses and nurses' aides in Europe. New high-risk groups include home- and long-term-care nurses and physiotherapists. A number of European countries are experiencing a shortage of healthcare workers. Light therapy has been shown to be an effective treatment for various musculoskeletal disorders, including lateral epicondylitis, temporomandibular joint pain, carpal tunnel syndrome, and delayed-onset muscle soreness. A systematic review and meta-analysis demonstrated that low-level laser therapy is an effective method for relieving non-specific chronic low back pain (NSCLBP). However, the efficacy of light-emitting diode (LED) therapy for NSCLBP is disputed. This study aims to evaluate the effect of LED therapy on NSCLBP.
METHODS AND ANALYSIS


We conducted a prospective, double-blind, randomized placebo-controlled trial of 148 patients with NSCLBP. The patients were randomly assigned to 2 groups: intervention group, where patients received LED photobiomodulation therapy 3 times a week for 2 weeks, and the sham group, where patients had sham therapy 3 times a week for 2 weeks. Primary outcome measures included the visual analog scale for pain, lumbar active range of motion assessments, and chair-rising times. Secondary outcome measures included a multidimensional fatigue inventory, fear-avoidance beliefs questionnaire, and the Oswestry disability index. The outcome measures were assessed before therapy and 2weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months after the first interventions were completed.
DISCUSSION


This study is a prospective, single-center, double-blind, randomized, controlled study. This study aims to research the efficacy of a 2-week LED program for NSCLBP working nurse. Our results will be useful for patients, working nurses, nurses' aides, and other healthcare workers with chronic low back pain.
TRIAL REGISTRATION NUMBER


NCT04424823.",2020,"Secondary outcome measures included a multidimensional fatigue inventory, fear-avoidance beliefs questionnaire, and the Oswestry disability index.","['non-specific low back pain in working nurses', ""hospital nurses and nurses' aides in Europe"", ""patients, working nurses, nurses' aides, and other healthcare workers with chronic low back pain"", '148 patients with NSCLBP']","['Light-emitting diode photobiomodulation therapy', 'LED therapy', 'light-emitting diode (LED) therapy', 'low-level laser therapy', 'LED photobiomodulation therapy', 'Light therapy', 'placebo']","['visual analog scale for pain, lumbar active range of motion assessments, and chair-rising times', 'multidimensional fatigue inventory, fear-avoidance beliefs questionnaire, and the Oswestry disability index']","[{'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1271036', 'cui_str': 'Hospital nurse'}, {'cui': 'C0028663', 'cui_str': 'Nursing aid'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1444228', 'cui_str': 'Range of motion assessment'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",148.0,0.57227,"Secondary outcome measures included a multidimensional fatigue inventory, fear-avoidance beliefs questionnaire, and the Oswestry disability index.","[{'ForeName': 'Yen-Po', 'Initials': 'YP', 'LastName': 'Lin', 'Affiliation': 'National Taiwan University Hospital Hsin-Chu Branch, Hsinchu City.'}, {'ForeName': 'Ying-Hao', 'Initials': 'YH', 'LastName': 'Su', 'Affiliation': 'National Taiwan University Hospital Hsin-Chu Branch, Hsinchu City.'}, {'ForeName': 'Shih-Fang', 'Initials': 'SF', 'LastName': 'Chin', 'Affiliation': 'National Taiwan University Hospital Hsin-Chu Branch, Hsinchu City.'}, {'ForeName': 'Yu-Ching', 'Initials': 'YC', 'LastName': 'Chou', 'Affiliation': 'School of Public Health, National Defense Medical Center, Taipei, Taiwan (R.O.C.).'}, {'ForeName': 'Wei-Tso', 'Initials': 'WT', 'LastName': 'Chia', 'Affiliation': 'National Taiwan University Hospital Hsin-Chu Branch, Hsinchu City.'}]",Medicine,['10.1097/MD.0000000000021611']
1954,32769965,Inotuzumab ozogamicin for relapsed/refractory acute lymphoblastic leukemia: outcomes by disease burden.,"Adults with relapsed/refractory acute lymphoblastic leukemia (R/R ALL) have a poor prognosis, especially if disease burden is high. This post hoc analysis of the phase 3 INO-VATE trial examined the efficacy and safety of inotuzumab ozogamicin (InO) vs. standard of care chemotherapy (SC) among R/R ALL patients with low, moderate, or high disease burden, respectively, defined as bone marrow blasts (BMB) < 50% (n = 53 vs. 48), 50-90% (n = 79 vs. 83), and >90% (n = 30 vs. 30). Patients in the InO vs. SC arm with low, moderate, and high BMB%, respectively, had improved rates of complete remission/complete remission with incomplete hematologic recovery (74% vs. 46% [p = 0.0022], 75 vs. 27% [p < 0.0001], and 70 vs. 17% [p < 0.0001]), and improved overall survival (hazard ratio: 0.64 [p = 0.0260], 0.81 [p = 0.1109], and 0.60 [p = 0.0335]). Irrespective of BMB%, cytopenias were the most common treatment-emergent adverse events, and post-transplant veno-occlusive disease was more common with InO vs. SC. Patients with extramedullary disease or lymphoblastic lymphoma showed similar efficacy and safety outcomes. This favorable benefit-to-risk ratio of InO treatment irrespective of disease burden supports its use in challenging and high disease burden subpopulations. INO-VATE is registered at www.clinicaltrials.gov : #NCT01564784.",2020,"Irrespective of BMB%, cytopenias were the most common treatment-emergent adverse events, and post-transplant veno-occlusive disease was more common with InO vs. SC.","['relapsed/refractory acute lymphoblastic leukemia', 'Patients with extramedullary disease or lymphoblastic lymphoma', 'R/R ALL patients with low, moderate, or high disease burden, respectively, defined as bone marrow blasts (BMB)\u2009<\u200950% (n\u2009=\u200953 vs. 48), 50-90% (n\u2009=\u200979 vs. 83), and >90% (n\u2009=\u200930 vs. 30', 'Adults with relapsed/refractory acute lymphoblastic leukemia (R/R ALL']","['Inotuzumab ozogamicin', 'inotuzumab ozogamicin (InO) vs. standard of care chemotherapy (SC']","['rates of complete remission/complete remission with incomplete hematologic recovery', 'overall survival']","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0079748', 'cui_str': 'Precursor cell lymphoblastic lymphoma'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0337026', 'cui_str': 'Blast'}, {'cui': 'C0439083', 'cui_str': '>90'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1567130', 'cui_str': 'inotuzumab ozogamicin'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0996714,"Irrespective of BMB%, cytopenias were the most common treatment-emergent adverse events, and post-transplant veno-occlusive disease was more common with InO vs. SC.","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'DeAngelo', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, 02215, USA. Daniel_Deangelo@dfci.harvard.edu.'}, {'ForeName': 'Anjali S', 'Initials': 'AS', 'LastName': 'Advani', 'Affiliation': 'Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, 44106, USA.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Marks', 'Affiliation': 'University Hospitals Bristol, Bristol, BS1 3NU, UK.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Stelljes', 'Affiliation': 'Universitätsklinikum Münster, 48149, Münster, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Liedtke', 'Affiliation': 'Stanford Cancer Institute, Stanford, CA, 94304, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Stock', 'Affiliation': 'University of Chicago, Chicago, IL, 60637, USA.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Gökbuget', 'Affiliation': 'Goethe University Hospital, 60596, Frankfurt, Germany.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Jabbour', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.'}, {'ForeName': 'Akil', 'Initials': 'A', 'LastName': 'Merchant', 'Affiliation': 'Cedars Sinai Medical Center, Los Angeles, CA, 90048, USA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Pfizer Inc, Cambridge, MA, 02139, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Vandendries', 'Affiliation': 'Pfizer Inc, Cambridge, MA, 02139, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Neuhof', 'Affiliation': 'Pfizer Pharma GmbH, 10785, Berlin, Germany.'}, {'ForeName': 'Hagop', 'Initials': 'H', 'LastName': 'Kantarjian', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': ""O'Brien"", 'Affiliation': 'Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange, CA, 92697, USA.'}]",Blood cancer journal,['10.1038/s41408-020-00345-8']
1955,32770131,"A randomized, double-blind water taste test to evaluate the equivalence of taste between tap water and filtered water in the Taipei metropolis.","High water quality and sufficient water availability are the main concerns of water users. Promoting the efficient use of tap water can contribute to sustainable drinking water management and progress towards Sustainable Development Goals. In many metropolises, water suppliers treat municipal water with appropriate treatment processes and well-maintained distribution infrastructure. Under this circumstance, it is acceptable that municipal water can be a source of drinking water. The presence of residual chlorine in tap water, connected to municipal water supply, inactivates pathogenic microorganisms and prevents recontamination. However, adding chlorine to tap water may affect the organoleptic properties of drinking water. On the other hand, the use of point-of-use (POU) water dispensers, which provides an additional treatment step on tap water, is not energy-efficient. A randomized, double-blind water taste test was conducted in the Taipei metropolis to assess whether tap water from public drinking fountains and filtered water from POU water dispensers have similar organoleptic properties. An odds ratio (OR) and the area under the receiver operating characteristic curve (AUC) were used to measure the participants' ability to distinguish between the two water varieties. A five-region hypothesis test was conducted to test the OR, and a 95% bootstrap confidence interval of the AUC was calculated. The results of the study showed that the 95% five-region confidence interval of OR equal to (0.5, 1.49), and the 95% bootstrap confidence interval of AUC equal to (0.42, 0.56). These results implied that people in the Taipei metropolis could not distinguish between tap water and filtered water. It is recommended that more drinking fountains be installed and maintained fully functional and clean to achieve excellence in tap water access.",2020,"The presence of residual chlorine in tap water, connected to municipal water supply, inactivates pathogenic microorganisms and prevents recontamination.",[],[],"['odds ratio (OR) and the area under the receiver operating characteristic curve (AUC', 'organoleptic properties of drinking water']",[],[],"[{'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}]",,0.0565847,"The presence of residual chlorine in tap water, connected to municipal water supply, inactivates pathogenic microorganisms and prevents recontamination.","[{'ForeName': 'Jing-Rong', 'Initials': 'JR', 'LastName': 'Jhuang', 'Affiliation': 'Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Rm. 536, No. 17, Xuzhou Rd., Taipei, 100, Taiwan.'}, {'ForeName': 'Wen-Chung', 'Initials': 'WC', 'LastName': 'Lee', 'Affiliation': 'Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Rm. 536, No. 17, Xuzhou Rd., Taipei, 100, Taiwan. wenchung@ntu.edu.tw.'}, {'ForeName': 'Chang-Chuan', 'Initials': 'CC', 'LastName': 'Chan', 'Affiliation': 'Innovation and Policy Center for Population Health and Sustainable Environment, College of Public Health, National Taiwan University, Taipei, Taiwan. ccchan@ntu.edu.tw.'}]",Scientific reports,['10.1038/s41598-020-70272-y']
1956,32775967,Understanding young peoples' and family members' views of treatment for first episode psychosis in a randomised controlled trial (MAPS).,"Background


There is limited evidence to inform treatment decision-making in adolescents experiencing first episode psychosis (FEP). In the MAPS trial (Managing Adolescent first Episode Psychosis: a feasibility Study), adolescents with FEP received either antipsychotic medication (AP), psychological intervention (PI), or both. We investigated treatment views of young people and family members across each treatment arm of MAPS.
Methods


Thirteen adolescents participating in MAPS and eighteen family members attended in-depth audio-recorded interviews to discuss trial treatments. Interviews were analysed using inductive Thematic Analysis, identifying salient themes across these accounts.
Findings


Family members in particular reported an urgent need for treatment regardless of type. Both AP and PI were broadly viewed as acceptable treatment approaches, but for differing reasons which participants weighed against a range of concerns. AP were often seen to reduce symptoms of psychosis, though participants expressed concerns about side effects. PI were viewed as interactive treatment approaches that helped improve understanding of psychosis and enhanced coping, although some found PI emotionally and cognitively challenging. Combining treatments was seen to maximise benefits, with a perceived interaction whereby AP facilitated engagement with PI.
Interpretation


Acceptability of and engagement with treatments for FEP may differ between individual young people and their family/carers. In order to be able to offer fully informed choices, and determine an optimum treatment approach for young people with FEP, definitive trial evidence should be established to determine wanted and unwanted treatment impacts.
Funding


NIHR HTA programme (project number 15/31/04).",2020,"PI were viewed as interactive treatment approaches that helped improve understanding of psychosis and enhanced coping, although some found PI emotionally and cognitively challenging.","['adolescents with FEP received either', 'young people with FEP', 'young people and family members across each treatment arm of MAPS', 'adolescents experiencing first episode psychosis (FEP', 'Thirteen adolescents participating in MAPS and eighteen family members attended in-depth audio-recorded interviews to discuss trial treatments']","['antipsychotic medication (AP), psychological intervention (PI), or both']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],13.0,0.042882,"PI were viewed as interactive treatment approaches that helped improve understanding of psychosis and enhanced coping, although some found PI emotionally and cognitively challenging.","[{'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Byrne', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Prestwich M25 3BL, UK.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Bird', 'Affiliation': 'Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, OX3 7JX, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Reeve', 'Affiliation': 'Department of Clinical, Educational, and Health Psychology, University College London, WC1E 6BT, UK.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Jones', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Prestwich M25 3BL, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Shiers', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Prestwich M25 3BL, UK.'}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Morrison', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Prestwich M25 3BL, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pyle', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Prestwich M25 3BL, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Division of Psychology and Mental Health, University of Manchester, Manchester, M13 9PL, UK.'}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100417']
1957,32775968,Clinicians' views of treatment types for first episode psychosis delivered in a randomised controlled trial (MAPS).,"Background


Clinicians' treatment beliefs could affect the feasibility of delivering different treatments in a randomised controlled trial (RCT). In MAPS (Managing Adolescent first Episode Psychosis: a feasibility Study), adolescents with first episode psychosis (FEP) were randomly allocated to receive either antipsychotic medication (AP), psychological intervention (cognitive behavioural therapy [CBT] and family intervention [FI]), or both. We conducted a nested qualitative study to investigate clinicians' views of these treatments.
Methods


Purposive sampling identified seventeen clinicians from CAMHS and Early Intervention services with prescribing responsibilities for 14-18 year olds at three participating MAPS sites. Individual participants were interviewed to examine their views of treatments in the MAPS trial. Interview transcripts were analysed using inductive Thematic Analysis.
Findings


Clinicians viewed the decision to refer adolescents to the MAPS trial as requiring careful clinical judgement. Assessment complexity and diagnostic uncertainty had to be balanced against the urgency for treatment to reduce risk and distress. Underlying influences including duty of care and treatment beliefs underpinned decisions. Clinicians consistently valued AP as the primary treatment for FEP, with CBT and/or FI seen as helpful secondary treatment options. Nevertheless, the potential harms of prescribing AP, or not, to such a young population were highlighted as being of concern in treatment decision-making, and fostered reluctance to refer into a RCT.
Interpretation


The design and delivery of RCTs involving young people experiencing FEP should consider the views of responsible clinicians, recognising that perceived treatment urgency, limitations in diagnostic precision, and existing treatment beliefs may influence trial processes.
Funding


NIHR HTA programme (project number 15/31/04).",2020,"Clinicians consistently valued AP as the primary treatment for FEP, with CBT and/or FI seen as helpful secondary treatment options.","['adolescents with first episode psychosis (FEP', 'seventeen clinicians from CAMHS and Early Intervention services with prescribing responsibilities for 14-18 year olds at three participating MAPS sites']","['antipsychotic medication (AP), psychological intervention (cognitive behavioural therapy [CBT] and family intervention [FI']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",[],,0.0430573,"Clinicians consistently valued AP as the primary treatment for FEP, with CBT and/or FI seen as helpful secondary treatment options.","[{'ForeName': 'Byrne', 'Initials': 'B', 'LastName': 'Re', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Prestwich, Manchester, M25 3BL, UK.'}, {'ForeName': 'Reeve', 'Initials': 'R', 'LastName': 'S', 'Affiliation': 'Department of Clinical, Educational, and Health Psychology, University College London, WC1E 6BT.'}, {'ForeName': 'Bird', 'Initials': 'B', 'LastName': 'Jc', 'Affiliation': 'Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, OX3 7JX, UK.'}, {'ForeName': 'Jones', 'Initials': 'J', 'LastName': 'W', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Prestwich, Manchester, M25 3BL, UK.'}, {'ForeName': 'Shiers', 'Initials': 'S', 'LastName': 'D', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Prestwich, Manchester, M25 3BL, UK.'}, {'ForeName': 'Morrison', 'Initials': 'M', 'LastName': 'Ap', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Prestwich, Manchester, M25 3BL, UK.'}, {'ForeName': 'Pyle', 'Initials': 'P', 'LastName': 'M', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Prestwich, Manchester, M25 3BL, UK.'}, {'ForeName': 'Peters', 'Initials': 'P', 'LastName': 'S', 'Affiliation': 'Division of Psychology and Mental Health, University of Manchester, Manchester, M13 9PL, UK.'}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100421']
1958,32775985,Vitamin D Analogues and Coronary Calcification in CKD Stages 3 and 4: A Randomized Controlled Trial of Calcitriol Versus Paricalcitol.,"Rationale & Objective


Mineral and bone disorder in chronic kidney disease (CKD) is associated with progression of coronary artery calcification (CAC). Mineral and bone disorder often is treated with calcitriol and other vitamin D receptor activators, including paricalcitol, agents that may have differential effects on calcium, phosphate, and parathyroid hormone levels. Accordingly, we investigated whether these agents have differential effects on CAC progression in patients with CKD.
Study Design


Randomized, double-concealed, 48-week clinical trial.
Setting & Participants


CKD stage 3 or 4 with secondary hyperparathyroidism with CAC score > 0 and no prior treatment with activated vitamin D.
Intervention


Calcitriol versus paricalcitol.
Outcomes


The primary outcome was log-transformed CAC change. Secondary outcomes included percent change in CAC volume, valvular calcifications, and bone mineral metabolism markers.
Results


Among 44 individuals randomly assigned, mean age was 65 years and mean estimated glomerular filtration rate was 27 mL/min/1.73 m 2 . Median CAC score was 140 (IQR, 55-277) Agatston units at baseline. There was no significant difference in CAC progression between treatment arms ( P  = 0.06). After adjustment for baseline CAC score (log), treatment group remains nonsignificant ( P  = 0.08). Further adjustment for creatinine level and/or CKD stage did not change the association. In secondary analyses adjusting for dose level of activated vitamin D, treatment group was significant ( P  = 0.01), and when dose level was also included in the model, the coefficient for individuals in the paricalcitol group was significantly associated with CAC progression ( P  = 0.02). An interaction term between dosing level and CKD stage was significant at the highest dosing level ( P  = 0.04).
Limitations


Pilot single-center study.
Conclusions


In patients with CKD with secondary hyperparathyroidism naive to activated vitamin D therapy, there was no difference in CAC or valvular progression in participants receiving calcitriol compared with paricalcitol during a 48-week period.
Funding


Abbvie, Inc.
Trial Registration


NCT00752102.",2020,"In secondary analyses adjusting for dose level of activated vitamin D, treatment group was significant ( P  = 0.01), and when dose level was also included in the model, the coefficient for individuals in the paricalcitol group was significantly associated with CAC progression ( P  = 0.02).","['patients with CKD with secondary hyperparathyroidism naive to', 'patients with CKD', 'Setting & Participants\n\n\nCKD stage 3 or 4 with secondary hyperparathyroidism with CAC score\xa0>\xa00 and no prior treatment with activated vitamin D.\nIntervention', '44 individuals randomly assigned, mean age was 65 years and mean estimated glomerular filtration rate was 27\xa0mL', 'chronic kidney disease (CKD']","['calcitriol', 'paricalcitol', 'Calcitriol versus paricalcitol', 'calcitriol and other vitamin D receptor activators', 'Calcitriol Versus Paricalcitol', 'activated vitamin D therapy']","['log-transformed CAC change', 'creatinine level and/or CKD stage', 'CAC progression', 'percent change in CAC volume, valvular calcifications, and bone mineral metabolism markers', 'CAC or valvular progression', 'Vitamin D Analogues and Coronary Calcification', 'Median CAC score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0020503', 'cui_str': 'Secondary hyperparathyroidism'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C2316787', 'cui_str': 'Chronic kidney disease stage 3'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]","[{'cui': 'C0006674', 'cui_str': 'Calcitriol'}, {'cui': 'C0249582', 'cui_str': 'paricalcitol'}, {'cui': 'C0108082', 'cui_str': 'Vitamin D3 Receptor'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1520059', 'cui_str': 'Vitamin D analog'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.21336,"In secondary analyses adjusting for dose level of activated vitamin D, treatment group was significant ( P  = 0.01), and when dose level was also included in the model, the coefficient for individuals in the paricalcitol group was significantly associated with CAC progression ( P  = 0.02).","[{'ForeName': 'Karim H', 'Initials': 'KH', 'LastName': 'Anis', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pober', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Sylvia E', 'Initials': 'SE', 'LastName': 'Rosas', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, MA.'}]",Kidney medicine,['10.1016/j.xkme.2020.05.009']
1959,32776101,"Changes in Biomarkers of Exposure on Switching From a Conventional Cigarette to the glo Tobacco Heating Product: A Randomized, Controlled Ambulatory Study.","INTRODUCTION


Tobacco heating products (THPs) generate lower machine yields of toxicants compared to those found in conventional cigarette smoke. During use, these products are likely to expose users to lower levels of particulate matter and harmful and potentially harmful compounds compared with smoking cigarettes.
AIMS AND METHODS


This randomized, controlled study is investigating whether biomarkers of exposure (BoE) to smoke toxicants are reduced when smokers switch from smoking cigarettes to using the glo THP in a naturalistic, ambulatory setting. Control groups include smokers who are abstaining from cigarette smoking and never-smokers. At a baseline study visit, 24-hour urine samples and spot blood samples were taken for BoE analysis, and exhaled carbon monoxide was also measured. N-(2-cyanoethyl) valine (CEVal) was used as a marker of compliance in subjects asked to refrain from combustible cigarette smoking. Subjects are being followed up at periodic intervals for 360 days; this article presents data following a planned interim analysis at day 90.
RESULTS


In continuing smokers, BoE remained stable between baseline (day 1) and day 90. In both per-protocol and CEVal-compliant analysis populations, reductions in BoE were observed in subjects switching to using glo or undergoing smoking cessation. These reductions were statistically significant for a number of BoE when switching to glo was compared with continued smoking. Furthermore, in both populations, reductions observed in subjects switching to using glo were comparable to those seen with smoking cessation and were also to levels similar to those seen in never-smokers.
CONCLUSION


glo is a reduced-exposure tobacco product.
IMPLICATIONS


This clinical study builds on a previous 5-day confinement study and demonstrates that when smokers switched from smoking combustible cigarettes to using the glo THP in a naturalistic, ambulatory setting, their exposure to tobacco smoke toxicants was significantly decreased. For most BoE examined, this was to the same extent as that seen when a control group of smokers ceased cigarette smoking, or even to levels seen in never-smoker controls. This indicates that glo is a reduced-exposure product with the potential to be a reduced-risk tobacco product, when used by smokers whose cigarette consumption is displaced completely.
CLINICAL TRIAL REGISTRATION


ISRCTN81075760.",2020,"For most BoE examined, this was to the same extent as that seen when a control group of smokers ceased cigarette smoking, or even to levels seen in never-smoker controls.","['subjects asked to refrain from combustible cigarette smoking', 'Control groups include smokers who are abstaining from cigarette smoking and never-smokers']","['valine (CEVal', 'Tobacco heating products (THPs', 'N-(2-cyanoethyl']","['tobacco smoke toxicants', 'exhaled carbon monoxide', 'number of BoE']","[{'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0425293', 'cui_str': 'Never smoked tobacco'}]","[{'cui': 'C0042285', 'cui_str': 'Valine'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0018851', 'cui_str': 'Heating'}]","[{'cui': 'C0439994', 'cui_str': 'Tobacco smoke'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",,0.0117907,"For most BoE examined, this was to the same extent as that seen when a control group of smokers ceased cigarette smoking, or even to levels seen in never-smoker controls.","[{'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Gale', 'Affiliation': 'British American Tobacco (Investments) Limited, Research and Development, Southampton, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McEwan', 'Affiliation': 'British American Tobacco (Investments) Limited, Research and Development, Southampton, UK.'}, {'ForeName': 'Oscar M', 'Initials': 'OM', 'LastName': 'Camacho', 'Affiliation': 'British American Tobacco (Investments) Limited, Research and Development, Southampton, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Hardie', 'Affiliation': 'British American Tobacco (Investments) Limited, Research and Development, Southampton, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Murphy', 'Affiliation': 'British American Tobacco (Investments) Limited, Research and Development, Southampton, UK.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Proctor', 'Affiliation': 'British American Tobacco (Investments) Limited, Research and Development, Southampton, UK.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa135']
1960,32769877,Protective effect of probiotics in patients with non-alcoholic fatty liver disease.,"To investigate the effects of probiotics on liver function, glucose and lipids metabolism, and hepatic fatty deposition in patients with non-alcoholic fatty liver disease (NAFLD).Totally 140 NAFLD cases diagnosed in our hospital from March 2017 to March 2019 were randomly divided into the observation group and control group, 70 cases in each. The control group received the diet and exercise therapy, while the observation group received oral probiotics based on the control group, and the intervention in 2 groups lasted for 3 months. The indexes of liver function, glucose and lipids metabolism, NAFLD activity score (NAS), and conditions of fecal flora in 2 groups were compared before and after the treatment.Before the treatment, there were no significant differences on alanine aminotransferase (ALT), aspartate aminotransferase (AST), glutamine transferase (GGT), total bilirubin (TBIL), total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), insulin resistance index (HOMA-IR), NAFLD activity score (NAS), and conditions of fecal flora in 2 groups (P > .05). After the treatment, ALT, AST, GGT, TC, TG, HOMA-IR, NAS, and conditions of fecal flora in the observation group were better than those in the control group, and the observation group was better after treatment than before. All these above differences were statistically significant (P < .05).Probiotics can improve some liver functions, glucose and lipids metabolism, hepatic fatty deposition in patients with NAFLD, which will enhance the therapeutic effects of NAFLD.",2020,"All these above differences were statistically significant (P < .05).Probiotics can improve some liver functions, glucose and lipids metabolism, hepatic fatty deposition in patients with NAFLD, which will enhance the therapeutic effects of NAFLD.","['patients with NAFLD', 'patients with non-alcoholic fatty liver disease (NAFLD).Totally 140 NAFLD cases diagnosed in our hospital from March 2017 to March 2019', 'patients with non-alcoholic fatty liver disease']","['diet and exercise therapy, while the observation group received oral probiotics', 'probiotics']","['ALT, AST, GGT, TC, TG, HOMA-IR, NAS, and conditions of fecal flora', 'liver functions, glucose and lipids metabolism, hepatic fatty deposition', 'liver function, glucose and lipids metabolism, and hepatic fatty deposition', 'indexes of liver function, glucose and lipids metabolism, NAFLD activity score (NAS), and conditions of fecal flora', 'alanine aminotransferase (ALT), aspartate aminotransferase (AST), glutamine transferase (GGT), total bilirubin (TBIL), total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), insulin resistance index (HOMA-IR), NAFLD activity score (NAS), and conditions of fecal flora']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}]","[{'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0333574', 'cui_str': 'Fatty deposition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0061485', 'cui_str': 'Glutamine phenylacetyltransferase'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]",,0.0164329,"All these above differences were statistically significant (P < .05).Probiotics can improve some liver functions, glucose and lipids metabolism, hepatic fatty deposition in patients with NAFLD, which will enhance the therapeutic effects of NAFLD.","[{'ForeName': 'Gen-Shen', 'Initials': 'GS', 'LastName': 'Cai', 'Affiliation': 'Department of General Medicine.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Department of Gastroenterology, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of General Medicine.'}]",Medicine,['10.1097/MD.0000000000021464']
1961,32769878,A phase 3 double-blind randomized (CONSORT-compliant) study of azilsartan medoxomil compared to valsartan in Chinese patients with essential hypertension.,"BACKGROUND


Azilsartan medoxomil (AZL-M), an angiotensin II receptor blocker, has a well-characterized efficacy and safety profile in patients with hypertension. AZL-M is approved for use in over 40 countries globally; however, it is not yet approved in China. Therefore, a phase 3 registration study to assess the efficacy (antihypertensive effect), safety, and tolerability of AZL-M compared with valsartan in Chinese patients with essential hypertension was undertaken.
METHODS


This multicenter, double-blind, randomized, 8-week phase 3 study compared AZL-M with valsartan in Chinese patients aged ≥18 years with essential hypertension. Endpoints included change from baseline to week 8 in trough sitting clinic systolic blood pressure (scSBP) and ambulatory blood pressure monitoring parameters.
RESULTS


Overall, 612 patients (mean age, 57.1 years; 57.5% male) were randomized to AZL-M 80 mg (n = 209), AZL-M 40 mg (n = 199), or valsartan 160 mg (n = 204). Baseline mean scSBP was similar in all groups (157.9-158.5 mm Hg). The mean reduction in trough scSBP from baseline to week 8 was significantly greater with AZL-M 80 mg than with valsartan (-24.2 vs -20.6 mm Hg; P = .010), and noninferior with AZL-M 40 mg versus valsartan (-22.5 vs -20.6 mm Hg; P = .184). Mean reduction in 24-hour mean systolic blood pressure (n = 257) was significantly greater with both AZL-M 80 mg (-17.0 mm Hg; P < .001) and AZL-M 40 mg (-14.7 mm Hg; P = .014) than with valsartan (-9.4 mm Hg). Treatment-emergent adverse events had similar incidence (52.8%-56.5%) across the treatment groups and were generally mild or moderate. Dizziness was the most frequent treatment-related treatment-emergent adverse events (AZL-M 80 mg, 1.9%; AZL-M 40 mg, 1.5%; valsartan, 1.0%). The safety and tolerability of AZL-M were comparable with valsartan.
CONCLUSIONS


AZL-M was noninferior to valsartan at the 40-mg dose and superior to valsartan at the 80-mg dose in reducing trough scSBP, and showed acceptable safety-consistent with the AZL-M safety profile in other populations-in Chinese adults with hypertension.
TRIAL REGISTRATION NUMBER


NCT02480764.",2020,Treatment-emergent adverse events had similar incidence (52.8%-56.5%) across the treatment groups and were generally mild or moderate.,"['612 patients (mean age, 57.1 years; 57.5% male', 'Chinese patients with essential hypertension was undertaken', 'Chinese patients with essential hypertension', 'patients with hypertension', 'Chinese patients aged ≥18 years with essential hypertension', 'Chinese adults with hypertension']","['AZL-M', 'valsartan', 'AZL-M with valsartan', 'AZL-M 40\u200amg (n\u200a=\u200a199), or valsartan', 'azilsartan medoxomil', 'Azilsartan medoxomil (AZL-M']","['Baseline mean scSBP', 'mean reduction in trough scSBP', 'efficacy (antihypertensive effect), safety, and tolerability', 'safety and tolerability of AZL-M', 'Mean reduction in 24-hour mean systolic blood pressure', 'Dizziness', 'trough sitting clinic systolic blood pressure (scSBP) and ambulatory blood pressure monitoring parameters']","[{'cui': 'C4517834', 'cui_str': '612'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2698291', 'cui_str': 'azilsartan medoxomil'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C2979834', 'cui_str': 'azilsartan medoxomil 40 MG'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2698291', 'cui_str': 'azilsartan medoxomil'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",612.0,0.157334,Treatment-emergent adverse events had similar incidence (52.8%-56.5%) across the treatment groups and were generally mild or moderate.,"[{'ForeName': 'Jiahui', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Beijing.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Beijing.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Lv', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Beijing.'}, {'ForeName': 'Zhanquan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, People's Hospital of Liaoning Province, Liaoning.""}, {'ForeName': 'Zeqi', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of NanChang University, Jiangxi.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Department of Cardiology, the Affiliated Hospital of Xuzhou Medical College.'}, {'ForeName': 'Chengchun', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiology, Southeast University, Zhongda Hospital, Jiangsu.'}, {'ForeName': 'Zhuhua', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': ""Department of Cardiology, Tianjin People's Hospital, Tianjin.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Hebei Cangzhou Central Hospital, Hebei.'}, {'ForeName': 'Mingzhi', 'Initials': 'M', 'LastName': 'Long', 'Affiliation': 'Department of Cardiology, Nanjing Medical University Affiliated 2nd Hospital, Jiangsu, China.'}, {'ForeName': 'Michie', 'Initials': 'M', 'LastName': 'Hisada', 'Affiliation': 'Global Patient Safety Evaluation, Takeda Development Center Americas, Inc., Deerfield, IL.'}, {'ForeName': 'Jingtao', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Statistics and Quantitative Sciences, Takeda Development Center Americas, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Clinical Science, Takeda Development Center Asia, Pte. Ltd., Shanghai, China.'}, {'ForeName': 'Changsheng', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Beijing.'}]",Medicine,['10.1097/MD.0000000000021465']
1962,32769884,The therapeutic effect of repetitive transcranial magnetic stimulation in elderly depression patients.,"BACKGROUND


Depression, a common psychiatric disorder in elderly, serves as a remarkable precipitating factor for suicide among the elderly people. Here, a randomized double-blinded study was performed to investigate the efficacy of repetitive transcranial magnetic stimulation (rTMS) on improving the clinical symptoms and reducing suicidal ideation in elderly patients with depression.
METHODS


In this study, 103 elderly patients with depression and suicidal ideation were randomly divided into 2 groups, 48 cases in the rTMS group and 55 cases in the control group (sham rTMS). Both groups received routine drug therapy with rTMS or sham rTMS. The patients received evaluation by Hamilton depression scale and self-rating idea of suicide scale before treatment and after 2 and 4 weeks of treatment, respectively.
RESULTS


The measurement from the present study demonstrated that Hamilton depression scale and self-rating idea of suicide scale scores decreased to varying degrees in the 2 groups after treatment, and the decrease was more significant in rTMS group. The rate of marked effectiveness was much higher in rTMS group after 2 weeks of treatment compared with the control group. Furthermore, the rate of moderate effectiveness at 4 weeks after treatment was significantly higher in rTMS group compared with the control group.
CONCLUSION


Together, the present study shows that rTMS with routine drug therapy exhibited effect with quick onset to improve the clinical symptoms and reduce suicidal ideation in elderly patients with depression.",2020,"Furthermore, the rate of moderate effectiveness at 4 weeks after treatment was significantly higher in rTMS group compared with the control group.
","['elderly depression patients', 'elderly patients with depression', '103 elderly patients with depression and suicidal ideation']","['repetitive transcranial magnetic stimulation', 'rTMS', 'control group (sham rTMS', 'routine drug therapy with rTMS or sham rTMS', 'repetitive transcranial magnetic stimulation (rTMS']","['Hamilton depression scale and self-rating idea of suicide scale', 'rate of marked effectiveness', 'suicidal ideation', 'Hamilton depression scale and self-rating idea of suicide scale scores', 'rate of moderate effectiveness']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0459920', 'cui_str': 'Ability to think abstractly'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",103.0,0.0269797,"Furthermore, the rate of moderate effectiveness at 4 weeks after treatment was significantly higher in rTMS group compared with the control group.
","[{'ForeName': 'Lilei', 'Initials': 'L', 'LastName': 'Dai', 'Affiliation': ""Department of Clinical Psychology, Jingmen NO.2 People's Hospital, Jingmen, Hubei.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ""Department of Psychiatry, The Affiliated Xi'an Central Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi.""}, {'ForeName': 'Panpan', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Psychology, Jingmen Oral Hospital, Jingmen, Hubei, China.'}, {'ForeName': 'Qingshan', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': ""Department of Clinical Psychology, Jingmen NO.2 People's Hospital, Jingmen, Hubei.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': ""Department of Clinical Psychology, Jingmen NO.2 People's Hospital, Jingmen, Hubei.""}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""Department of Clinical Psychology, Jingmen NO.2 People's Hospital, Jingmen, Hubei.""}, {'ForeName': 'Xinfu', 'Initials': 'X', 'LastName': 'He', 'Affiliation': ""Department of Clinical Psychology, Jingmen NO.2 People's Hospital, Jingmen, Hubei.""}, {'ForeName': 'Rongrong', 'Initials': 'R', 'LastName': 'Luan', 'Affiliation': ""Department of Psychiatry, The Affiliated Xi'an Central Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi.""}]",Medicine,['10.1097/MD.0000000000021493']
1963,32769888,Computer-navigated versus conventional total knee arthroplasty: A randomized controlled trial protocol in China.,"BACKGROUND


The literature lacks studies that confirm whether the improved radiographic alignment that can be achieved with computer-navigated total knee arthroplasty (TKA) improves patients' activities of daily living or the durability of total knee prostheses. Thus, in this protocol, we designed a randomized controlled trial to compare implant alignment, functional scores, and survival of the implant using computer-assisted surgery versus a conventional surgical technique.
METHODS


This prospective, blinded randomized controlled trial was conducted at our single hospital. This study was approved by the ethics committee of Jiaxing Second Hospital. The patient inclusion criteria were age 20 to 80 years' old, a body mass index of ≤35 kg/m, and consented for primary knee arthroplasty performed through a medial parapatellar approach by the senior author. We randomized consented study participants on a 1:1 ratio to 1 of 2 study groups using a computer-generated list of random numbers in varying block sizes. The primary outcome in this study was the Knee Injury and Osteoarthritis Outcome Score. Secondary outcomes were the Knee Society Score, Western Ontario and McMaster Universities Osteoarthritis Index, complications, and range of motion together with alignment and rotational positioning of the implant. Statistical significance was defined as a P value of ≤0.05.
CONCLUSIONS


Authors hypothesized that computer-assisted surgery in primary TKA improves implant alignment, functional scores, and survival of the implant compared to the conventional technique.",2020,"Secondary outcomes were the Knee Society Score, Western Ontario and McMaster Universities Osteoarthritis Index, complications, and range of motion together with alignment and rotational positioning of the implant.","[""patient inclusion criteria were age 20 to 80 years' old, a body mass index of ≤35\u200akg/m, and consented for primary knee arthroplasty performed through a medial parapatellar approach by the senior author""]","['computer-navigated total knee arthroplasty (TKA', 'implant using computer-assisted surgery versus a conventional surgical technique', 'Computer-navigated versus conventional total knee arthroplasty']","['implant alignment, functional scores, and survival of the implant', 'Knee Society Score, Western Ontario and McMaster Universities Osteoarthritis Index, complications, and range of motion together with alignment and rotational positioning of the implant', 'Knee Injury and Osteoarthritis Outcome Score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0442141', 'cui_str': 'Medial parapatellar approach'}, {'cui': 'C3812881', 'cui_str': 'Author'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0949696', 'cui_str': 'Computer-Assisted Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}]",,0.166324,"Secondary outcomes were the Knee Society Score, Western Ontario and McMaster Universities Osteoarthritis Index, complications, and range of motion together with alignment and rotational positioning of the implant.","[{'ForeName': 'Yefeng', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of orthopedics, Jiaxing Second Hospital, Zhejiang Province, China.'}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Sheng', 'Affiliation': ''}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021508']
1964,32770640,Secukinumab improves signs and symptoms of non-radiographic axial spondyloarthritis: primary results of a randomized controlled phase III study.,"OBJECTIVE


To report the primary (1-year) results from PREVENT, the first phase III study evaluating secukinumab in patients with active non-radiographic axial spondyloarthritis (nr-axSpA).
METHODS


A total of 555 patients were randomized (1:1:1) to subcutaneous secukinumab 150 mg with loading (LD), without loading (NL), or placebo weekly and then every 4 weeks starting at Week 4. NL group received placebo at Weeks 1, 2, and 3 to maintain blinding. Switch to open-label secukinumab (OL) or standard of care (SoC) was permitted after Week 20. The study had 2 independent analysis plans per EU and non-US (Plan A: Week 16) and US (Plan B: Week 52) regulatory requirements. Primary endpoint was ASAS40 at Week 16 (LD) and at Week 52 (NL) in tumor necrosis factor inhibitor (TNFi)-naïve patients. Safety analyses included all patients who received ≥1 dose of study treatment.
RESULTS


Overall, 481 patients completed 52 weeks treatment: 84.3% (156/185) LD, 89.7% (165/184) NL, and 86.0% (160/186) placebo. Proportion of patients who switched to OL or SoC between Weeks 20 and 48 was 50.8% LD, 47.3% NL, and 64.0% placebo. Both primary and all secondary endpoints were met at Week 16. ASAS40 in TNFi-naïve patients was significantly higher for LD (41.5%) at Week 16 and NL (39.8%) at Week 52 versus placebo (29.2% at Week 16 and 19.9% at Week 52; both P <0.05). No new safety findings were reported.
CONCLUSIONS


Secukinumab 150 mg provided significant and sustained improvement in signs and symptoms of patients with nr-axSpA through 52 weeks. Safety was consistent with previous reports.",2020,"CONCLUSIONS


Secukinumab 150 mg provided significant and sustained improvement in signs and symptoms of patients with nr-axSpA through 52 weeks.","['patients who received ≥1 dose of study treatment', 'A total of 555 patients', 'patients with active non-radiographic axial spondyloarthritis (nr-axSpA']","['subcutaneous secukinumab 150 mg with loading (LD), without loading (NL), or placebo', 'open-label secukinumab (OL) or standard of care (SoC', 'Secukinumab', 'ASAS40', 'placebo']",['signs and symptoms of non-radiographic axial spondyloarthritis'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517810', 'cui_str': '555'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3889038', 'cui_str': 'Non-radiographic axial spondyloarthritis'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C3889038', 'cui_str': 'Non-radiographic axial spondyloarthritis'}]",555.0,0.186013,"CONCLUSIONS


Secukinumab 150 mg provided significant and sustained improvement in signs and symptoms of patients with nr-axSpA through 52 weeks.","[{'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Deodhar', 'Affiliation': 'Oregon Health & Science University, Portland, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Blanco', 'Affiliation': 'Hospital University Marqués de Valdecilla, IDIVAL, Santander, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Dokoupilová', 'Affiliation': 'MEDICAL PLUS s.r.o., Uherske Hradiste, University of Veterinary and Pharmaceutical sciences, Brno, Czech Republic.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Hall', 'Affiliation': 'Monash University, Melbourne, Australia.'}, {'ForeName': 'Hideto', 'Initials': 'H', 'LastName': 'Kameda', 'Affiliation': 'Toho University, Tokyo, Japan.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, USA.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Poddubnyy', 'Affiliation': 'Charité Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'van de Sande', 'Affiliation': 'Amsterdam UMC, AMC/University of Amsterdam, Department of Rheumatology and Clinical Immunology, Amsterdam Infection & Immunity Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Anna S', 'Initials': 'AS', 'LastName': 'Wiksten', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Brian O', 'Initials': 'BO', 'LastName': 'Porter', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, USA.'}, {'ForeName': 'Hanno B', 'Initials': 'HB', 'LastName': 'Richards', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Haemmerle', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Braun', 'Affiliation': 'Rheumazentrum Ruhrgebiet Herne, and Ruhr-University Bochum, Bochum, Germany.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41477']
1965,32768682,Weight management for adults with mobility related disabilities: Rationale and design for an 18-month randomized trial.,"Adults with mobility related disabilities (MRDs) represent an underserved group with a high prevalence of overweight/obesity and limited options for weight management. We previously demonstrated clinically meaningful 12-month weight loss in adults with MRDs (-6.2%, 36% ≥5% of baseline weight) using an enhanced Stop Light Diet (eSLD) delivered using at home face-to-face behavioral sessions and optional physical activity. However, the costs/logistics associated with intervention delivery by individual home visits limits the potential for scaling and implementation of this approach. Thus, we will conduct a two-arm randomized trial in 128 overweight/obese adults with MRDs to compare weight loss (6 mos.) and maintenance (12 mos.) between interventions utilizing the eSLD, behavioral counseling, and increased physical activity delivered to individual participants in their homes or delivered to groups of participants in their homes remotely via video conferencing. The primary aim will compare weight loss between interventions arms across 6 months. Secondarily, we will compare weight loss (0-18 mos.), the proportion of participants who achieve clinically meaningful weight loss (≥5%) from 0 to 6 and 0 to18 months, and changes in quality of life from 0 to 6 and 0 to 18 months between interventions arms. We will also conduct cost, cost-effectiveness and contingent valuation comparisons and explore the influence of behavioral session attendance, compliance with the recommendations for diet and physical activity, self-monitoring of diet and physical activity, barriers to physical activity, sleep quality, and medications on weight change across 6 and 18 months. NCT REGISTRATION: NCT04046471.",2020,"We previously demonstrated clinically meaningful 12-month weight loss in adults with MRDs (-6.2%, 36% ≥5% of baseline weight) using an enhanced Stop Light Diet (eSLD) delivered using at home face-to-face behavioral sessions and optional physical activity.","['adults with mobility related disabilities', 'adults with MRDs (-6.2%, 36% ≥5% of baseline weight) using an', '128 overweight/obese adults with MRDs to compare weight loss (6 mos.) and maintenance (12 mos.) between', 'Adults with mobility related disabilities (MRDs']","['Weight management', 'enhanced Stop Light Diet (eSLD', 'interventions utilizing the eSLD, behavioral counseling, and increased physical activity delivered to individual participants in their homes or delivered to groups of participants in their homes remotely via video conferencing']","['quality of life', 'weight loss', 'physical activity, sleep quality, and medications on weight change', 'meaningful weight loss']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C1303013', 'cui_str': 'Baseline weight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0419181', 'cui_str': 'Light diet'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",128.0,0.0374796,"We previously demonstrated clinically meaningful 12-month weight loss in adults with MRDs (-6.2%, 36% ≥5% of baseline weight) using an enhanced Stop Light Diet (eSLD) delivered using at home face-to-face behavioral sessions and optional physical activity.","[{'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Washburn', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: rwashburn@ku.edu.'}, {'ForeName': 'Lauren T', 'Initials': 'LT', 'LastName': 'Ptomey', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: lptomey@kumc.edu.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Gorczyca', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: agorczyca@kumc.edu.'}, {'ForeName': 'Patricia R', 'Initials': 'PR', 'LastName': 'Smith', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: psmith18@kumc.edu.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Mayo', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: mmayo@kumc.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'Department of Population Health, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: rlee2@kumc.edu.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: jdonnelly@ku.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106098']
1966,32768694,"Re: Arshad S, Kilgore P, Chaudhry ZS et al. Treatment with Hydroxychloroquine, Azithromycin, and Combination in Patients Hospitalized with COVID-19. Int J Infect Dis: 2020. Epub 2020 Jul 1 http://doi.org/10.1016/j.ijid.2020.06.099.",,2020,,"['Patients Hospitalized with COVID-19', 'Epub 2020']","['Hydroxychloroquine, Azithromycin, and Combination']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]",[],,0.0210752,,"[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Wiseman', 'Affiliation': 'Synechion, Inc., 18208 Preston Road, Suite D9-405, Dallas, TX 75252. Electronic address: synechion@aol.com.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.07.064']
1967,32768993,The relationship between insomnia and the intensity of drinking in treatment-seeking individuals with alcohol dependence.,"BACKGROUND


Although insomnia is highly prevalent in alcohol use disorders(AUD), its associations with the severity of alcohol use, pre-existing psychiatric comorbidities and psychosocial problems are understudied. The present study evaluates the interplay between these factors using a structural equation model (SEM).
METHODS


We assessed baseline cross-sectional data on patients with AUD (N = 123) recruited to a placebo-controlled medication trial. Severity of alcohol use was measured by the Brief Michigan Alcoholism Screening Test (B-MAST). Insomnia Severity Index was used to assess insomnia symptoms. The Hamilton scales for Depression and Anxiety, Short Index of Problems and Timeline Follow Back evaluated psychiatric symptoms, psychosocial consequences of drinking and level of alcohol consumption respectively. We used logistic regression to evaluate the association between insomnia and severity of alcohol use while controlling for covariates. We constructed a SEM with observed variables to delineate the effect of psychiatric symptoms, psychosocial factors and current alcohol use on the pathway between alcohol use severity and insomnia.
RESULTS


The sample was predominately male(83.9 %), Black(54.6 %) and employed(60.0 %). About 45 % of the participants reported moderate-severe insomnia.The association between insomnia and B-MAST attenuated after adjustment for demographics, psychiatric symptoms and psychosocial problems(OR[95 % CI] = 1.17(0.99-1.47). SEM findings demonstrated that B-MAST and insomnia were linked to psychiatric symptoms (95 % Asymptotic-Confidence Interval (ACI): 0.015-0.159, p < 0.05) but not to psychosocial problems or current alcohol use.
CONCLUSION


Among treatment-seeking patients with AUD, psychiatric burden mediated the relationship between severity of alcohol use and insomnia. Clinicians should screen for underlying psychiatric disorders among treatment-seeking patients with AUD complaining of insomnia.",2020,"The association between insomnia and B-MAST attenuated after adjustment for demographics, psychiatric symptoms and psychosocial problems(OR[95 % CI] =","['patients with AUD (N = 123) recruited to a placebo-controlled medication trial', 'treatment-seeking patients with AUD', 'treatment-seeking patients with AUD complaining of insomnia', 'treatment-seeking individuals with alcohol dependence']",[],"['Hamilton scales for Depression and Anxiety, Short Index of Problems and Timeline Follow Back evaluated psychiatric symptoms, psychosocial consequences of drinking and level of alcohol consumption respectively', 'Insomnia Severity Index', 'insomnia symptoms', 'psychiatric symptoms', 'moderate-severe insomnia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439022', 'cui_str': 'Complaining of insomnia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}]",[],"[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",123.0,0.022062,"The association between insomnia and B-MAST attenuated after adjustment for demographics, psychiatric symptoms and psychosocial problems(OR[95 % CI] =","[{'ForeName': 'Ninad S', 'Initials': 'NS', 'LastName': 'Chaudhary', 'Affiliation': 'University of Alabama at Birmingham School of Public Health, 1665 University Blvd, Birmingham, AL, 35211, USA. Electronic address: ninadsc@uab.edu.'}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Wong', 'Affiliation': 'Idaho State University, 921 S 8th Ave, Stop 8112, Pocatello, ID, 83209, USA.'}, {'ForeName': 'Bhanu Prakash', 'Initials': 'BP', 'LastName': 'Kolla', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, 2nd ST SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Kyle M', 'Initials': 'KM', 'LastName': 'Kampman', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, 3400 Civic Center Blvd, Philadelphia, PA, 19104, USA; Cpl. Michael J. Crescenz VA Medical Center, 3900 Woodland Ave, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Subhajit', 'Initials': 'S', 'LastName': 'Chakravorty', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, 3400 Civic Center Blvd, Philadelphia, PA, 19104, USA; Cpl. Michael J. Crescenz VA Medical Center, 3900 Woodland Ave, Philadelphia, PA, 19104, USA. Electronic address: Subhajit.Chakravorty@uphs.upenn.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108189']
1968,32769027,Does CPAP treat depressive symptoms in individuals with OSA? An analysis of two 12-week randomized sham CPAP-controlled trials.,"BACKGROUND


Depression is common in patients with obstructive sleep apnea (OSA). Whether treating OSA with continuous positive airway pressure (CPAP) improves depressive symptoms remains inconclusive. We examined the impact of CPAP on depressive symptoms in OSA patients compared to sham CPAP.
METHODS


A sub-analysis of two previous randomized sham-controlled trials was conducted. 126 male OSA patients (age = 51 ± 11 years; BMI = 32.0 ± 5.1 kg/m 2 ; apnea hypopnea index = 42.4 ± 22.6 events/hour) were randomised either to therapeutic CPAP (n = 65) or sham CPAP (n = 61). Depressive symptoms were measured using the Depression, Anxiety and Stress Scale (DASS). The main outcome was the change in the DASS depression score (DASSD) after three months between the therapeutic and sham CPAP arms.
RESULTS


The change in DASSD at three months did not differ between therapeutic and sham CPAP (mean difference: 0.5, 95% CI -3.6 to 4.6, p = 0.80). There was no significant between-group differences within the sub-groups of adherent users (device usage≥4hrs/day), or those with baseline depression (DASSD>9). In a secondary analysis of patients with baseline depression, adherent therapeutic CPAP use was associated with a greater reduction in DASSD scores compared to non-adherers (-10.0, 95% CI -18.3 to -1.8, p = 0.019).
CONCLUSIONS


Overall, three months of CPAP did not significantly improve depression scores in OSA patients. Adherent use of therapeutic CPAP in patients with baseline depressive symptoms was associated with a reduction in symptom score. Future trials involving OSA patients with higher depressive symptoms will enable us to understand the complex interaction between OSA and depression.",2020,"There was no significant between-group differences within the sub-groups of adherent users (device usage≥4hrs/day), or those with baseline depression (DASSD>9).","['OSA patients with higher depressive symptoms', '126 male OSA patients (age\xa0=\xa051\xa0±\xa011 years; BMI\xa0=\xa032.0\xa0±\xa05.1\xa0kg/m 2 ; apnea hypopnea index\xa0=\xa042.4\xa0±\xa022.6 events/hour', 'patients with baseline depressive symptoms', 'individuals with OSA', 'OSA patients', 'patients with obstructive sleep apnea (OSA']","['OSA with continuous positive airway pressure (CPAP', 'sham CPAP', 'CPAP', 'therapeutic CPAP']","['depression scores', 'Depression, Anxiety and Stress Scale (DASS', 'change in DASSD', 'Depressive symptoms', 'DASSD scores', 'DASS depression score (DASSD', 'depressive symptoms']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",126.0,0.313538,"There was no significant between-group differences within the sub-groups of adherent users (device usage≥4hrs/day), or those with baseline depression (DASSD>9).","[{'ForeName': 'Yingjuan', 'Initials': 'Y', 'LastName': 'Mok', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Department of Sleep Medicine, Surgery and Science, Department of Respiratory and Critical Care Medicine, Changi General Hospital, Singapore.'}, {'ForeName': 'Kerri L', 'Initials': 'KL', 'LastName': 'Melehan', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Craig L', 'Initials': 'CL', 'LastName': 'Phillips', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Brendon J', 'Initials': 'BJ', 'LastName': 'Yee', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Miller', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Grunstein', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Delwyn', 'Initials': 'D', 'LastName': 'Bartlett', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia.'}, {'ForeName': 'Peter Y', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'The Lundquist Institute of Biomedical Innovation at Harbor-UCLA Medical Center Torrance, California, USA.'}, {'ForeName': 'Keith K', 'Initials': 'KK', 'LastName': 'Wong', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Camilla M', 'Initials': 'CM', 'LastName': 'Hoyos', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; School of Psychology, Brain and Mind Centre and Charles Perkins Centre, University of Sydney, Sydney, NSW, Australia. Electronic address: camilla.hoyos@sydney.edu.au.'}]",Sleep medicine,['10.1016/j.sleep.2020.04.021']
1969,32769065,The effects of foot reflexology on agitation and extubation time in male patients following coronary artery bypass surgery: A randomized controlled clinical trial.,"BACKGROUND AND PURPOSE


This study examined the effects of foot reflexology on agitation and extubation time of male patients following coronary artery bypass graft surgery.
MATERIALS AND METHODS


In this randomized three-arm controlled clinical trial, participants (n = 120) were randomly assigned to the intervention, placebo, or control groups. The intervention group received foot reflexology massage for 15 min. Agitation was assessed using the Richmond Agitation- Sedation Scale before the intervention (Time 1) and immediately (Time 2) and 10 min after the intervention (Time 3). Extubation time was measured as the time from gaining full consciousness to endotracheal extubation.
RESULTS


Agitation reduced in all groups from Time 1 to Time 3 (p < 0.05); however, the intervention group showed a significantly higher reduction at Time 2 (p < 0.001) and Time 3 (p < 0.001). Also, extubation time was significantly shorter in the intervention group (p < 0.01).
CONCLUSION


Foot reflexology may be introduced as a nursing intervention to facilitate the weaning process in the cardiac ICUs.",2020,"RESULTS


Agitation reduced in all groups from Time 1 to Time 3 (p < 0.05); however, the intervention group showed a significantly higher reduction at Time 2 (p < 0.001) and Time 3 (p < 0.001).","['male patients following coronary artery bypass surgery', 'male patients following coronary artery bypass graft surgery', 'participants (n\xa0=\xa0120']","['foot reflexology', 'foot reflexology massage', 'placebo']","['agitation and extubation time', 'Extubation time', 'extubation time', 'Richmond Agitation- Sedation Scale', 'Agitation']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}]",120.0,0.0559303,"RESULTS


Agitation reduced in all groups from Time 1 to Time 3 (p < 0.05); however, the intervention group showed a significantly higher reduction at Time 2 (p < 0.001) and Time 3 (p < 0.001).","[{'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Allahbakhhsian', 'Affiliation': 'Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Gholizadeh', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Sydney, Australia. Electronic address: Leila.gholizadeh@uts.edu.au.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Allahbakhshian', 'Affiliation': 'Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences. Tehran, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Sarbakhsh', 'Affiliation': 'Faculty of Public Health, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Abbaszadeh', 'Affiliation': 'Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: abbaszadeh_yaser@yahoo.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101201']
1970,32769165,Correction:  Patient-reported outcomes at discontinuation of anti-angiogenesis therapy in the randomized trial of chemotherapy with bevacizumab for advanced cervical cancer: an NRG Oncology Group study .,,2020,,['advanced cervical cancer'],"['anti-angiogenesis therapy', 'chemotherapy with bevacizumab']",[],"[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]",[],,0.0253617,,[],International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-000869corr1']
1971,32772383,Opioid and Dopamine Genes Interact to Predict Naltrexone Response in a Randomized Alcohol Use Disorder Clinical Trial.,"BACKGROUND


While the opiate antagonist, naltrexone, is approved for Alcohol Use Disorder (AUD), not everyone benefits. This study evaluated whether the OPRM1 SNP rs1799971 interacts with the dopamine transporter gene DAT1/SLC6A3 VNTR rs28363170 or the catechol-o-methyltransferase (COMT) gene SNP rs4680 in predicting naltrexone response.
METHODS


Individuals who met DSM-IV alcohol dependence were randomly assigned to naltrexone (50 mg/day) or placebo based on their OPRM1 genotype (75 G allele carriers and 77 A allele homozygotes) and also genotyped for DAT1 VNTR (9 vs 10 repeats) or COMT SNP (val/val vs. met carriers). Heavy drinking days (%HDD) were evaluated over 16 weeks and at the end of treatment. Effect sizes (d) for naltrexone response were calculated based on genotypes.
RESULTS


Naltrexone, relative to placebo, significantly reduced %HDD among OPRM1 G carriers who also had DAT1 10/10 (p=0.021, d=0.72) or COMT val/val genotypes (p=0.05, d=0.80), and to a lesser degree in those OPRM1 A homozygotes who were also DAT1 9-repeat carriers (p=0.09, d=0.70) or COMT met carriers (p=0.03, d=0.63). All other genotype combinations showed no differential response to naltrexone. Diarrhea/abdominal pain was more prominent in OPRM1 A homozygotes who were also DAT 9 or COMT met carriers.
CONCLUSIONS


These results suggest that Individuals with AUD with a more opioid-responsive genotype (OPRM1 G carriers) respond better to naltrexone if they have genotypes indicating normal/less dopamine tone (DAT1 10,10 or COMT val,val), while those with a less responsive opioid-responsive genotype (OPRM1 A homozygotes) respond better to naltrexone if they have genotypes indicating greater dopamine tone (DAT1 9-repeat or COMT met carriers). These results could lead to more personalized AUD treatments.",2020,Diarrhea/abdominal pain was more prominent in OPRM1,"['Individuals with AUD with a more opioid-responsive genotype (OPRM1 G carriers', 'Individuals who met DSM-IV alcohol dependence']","['naltrexone', 'placebo based on their OPRM1 genotype', 'Opioid and Dopamine Genes', 'Naltrexone', 'COMT SNP', 'OPRM1', 'placebo']",['Diarrhea/abdominal pain'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0007407', 'cui_str': 'Catechol methyltransferase'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}]",,0.0717863,Diarrhea/abdominal pain was more prominent in OPRM1,"[{'ForeName': 'Raymond F', 'Initials': 'RF', 'LastName': 'Anton', 'Affiliation': 'Medical University of South Carolina, Department of Psychiatry and Behavioral Sciences, Addiction Sciences Division, Charleston, USA.'}, {'ForeName': 'Konstantin E', 'Initials': 'KE', 'LastName': 'Voronin', 'Affiliation': 'Medical University of South Carolina, Department of Psychiatry and Behavioral Sciences, Addiction Sciences Division, Charleston, USA.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Book', 'Affiliation': 'Medical University of South Carolina, Department of Psychiatry and Behavioral Sciences, Addiction Sciences Division, Charleston, USA.'}, {'ForeName': 'Patricia K', 'Initials': 'PK', 'LastName': 'Latham', 'Affiliation': 'Medical University of South Carolina, Department of Psychiatry and Behavioral Sciences, Addiction Sciences Division, Charleston, USA.'}, {'ForeName': 'Patrick K', 'Initials': 'PK', 'LastName': 'Randall', 'Affiliation': 'Medical University of South Carolina, Department of Psychiatry and Behavioral Sciences, Addiction Sciences Division, Charleston, USA.'}, {'ForeName': 'W Bailey', 'Initials': 'WB', 'LastName': 'Glen', 'Affiliation': 'Medical University of South Carolina, Department of Psychiatry and Behavioral Sciences, Addiction Sciences Division, Charleston, USA.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Hoffman', 'Affiliation': 'Medical University of South Carolina, Department of Psychiatry and Behavioral Sciences, Addiction Sciences Division, Charleston, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Schacht', 'Affiliation': 'Medical University of South Carolina, Department of Psychiatry and Behavioral Sciences, Addiction Sciences Division, Charleston, USA.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14431']
1972,32772395,A parallel 3-group randomized clinical trial comparing different implant treatment options for the edentulous mandible: 1-year effects on dental patient-reported outcomes and chewing function.,"OBJECTIVE


This parallel three-group randomized clinical trial compared the 1-year changes in dental patient-reported outcomes and chewing function associated with three treatment strategies for the edentulous mandible: single-implant (G-I; n=11) or two-implant overdentures (G-II; n=13), and fixed 4-implant complete denture (G-III; n=13).
METHODS


Complete denture (CD) treatment was provided to all participants and after an adaptation period, they were randomly assigned to one of the three study groups. Implants (Neodent TI-Cortical, Brazil) were inserted using single-stage surgery and conventional loading. The mandibular dentures were incorporated into implants using specific retention systems and procedures according to the treatment group: O'ring/ball attachments for G-I and GII, and mini-conical abutments for G-III. Patients were assessed at baseline (CD stage) and up to 1-year after implant-retained prosthodontic treatment. Treatment outcomes included oral health-related quality of life (OHIP-Edent), satisfaction with the dentures, and chewing function using a mixing ability test. Data analyses included pairwise comparison tests, estimates of effect sizes, and regression analysis using Generalized Estimating Equations.
RESULTS


Results showed improvement in patient-reported outcomes (lower OHIP-Edent scores and higher satisfaction) and chewing function, compared to baseline. No significant between-group differences were found, although effect sizes were lower for G-III.
CONCLUSIONS


All treatments improved the assessed outcomes after transition from the baseline condition. Findings suggest that simplified implant treatments for edentulous patients result in favorable outcomes and may be considered as suitable alternatives to more complex interventions.",2020,"Treatment outcomes included oral health-related quality of life (OHIP-Edent), satisfaction with the dentures, and chewing function using a mixing ability test.","['Complete denture (CD) treatment was provided to all participants and after an adaptation period', 'edentulous patients']",['implant (G-I; n=11) or two-implant overdentures'],"['oral health-related quality of life (OHIP-Edent), satisfaction with the dentures, and chewing function using a mixing ability test', 'patient-reported outcomes (lower OHIP-Edent scores and higher satisfaction) and chewing function']","[{'cui': 'C0011455', 'cui_str': 'Complete denture'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0011459', 'cui_str': 'Overlay denture'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0799054,"Treatment outcomes included oral health-related quality of life (OHIP-Edent), satisfaction with the dentures, and chewing function using a mixing ability test.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Hartmann', 'Affiliation': 'Federal University of Goias, Goiania, Brazil.'}, {'ForeName': 'Ana Clara Freitas', 'Initials': 'ACF', 'LastName': 'de Menezes Bandeira', 'Affiliation': 'Federal University of Goias, Goiania, Brazil.'}, {'ForeName': 'Sara Cristina', 'Initials': 'SC', 'LastName': 'de Araújo', 'Affiliation': 'Federal University of Goias, Goiania, Brazil.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Brägger', 'Affiliation': 'Department of Reconstructive Dentistry, School of Dental Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schimmel', 'Affiliation': 'Department of Reconstructive Dentistry, School of Dental Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Cláudio Rodrigues', 'Initials': 'CR', 'LastName': 'Leles', 'Affiliation': 'Department of Reconstructive Dentistry, School of Dental Medicine, University of Bern, Bern, Switzerland.'}]",Journal of oral rehabilitation,['10.1111/joor.13070']
1973,32772451,An exploratory randomized controlled trial evaluating text prompts in Lebanon to encourage health-seeking behavior for hypertension.,"AIMS OF THE STUDY


The current study evaluates the effectiveness of an opportunistic mobile screening on the percentage of people who are aware of whether they may be hypertensive (in an observational study) and the effectiveness of reminder prompts on the percentage of people who seek further medical attention (in a randomized controlled trial).
METHODS USED TO CONDUCT THE STUDY


The screening of 1227 participants (529 female) was conducted during the registration period of the 2018 Beirut International Marathon in Lebanon. Next, 266 participants whose screening indicated hypertension (64 Female) were randomly allocated to a treatment group or a control group in a 1:1 fashion. The treatment group received a reminder prompt to seek further medical attention for their potential hypertension and the control group did not. The overt nature of the text message meant that participants in the treatment group could not be blinded to their group allocation. The primary outcome is participants' self-reports of whether they sought further medical attention.
RESULTS OF THE STUDY


For the opportunistic screening, a 25% prevalence rate and a 24% awareness rate of hypertension was indicated. A McNemar analysis suggested that the screening increased participant awareness (X 2  (N =1227)=72.16, p<0.001). For the randomized controlled trial, 219 participants provided follow-up data via a phone call (82% retention). A Chi-squared analysis suggested that the reminder prompt successfully encouraged more participants to seek further medical attention, 45.5% treatment group vs. 28.0% control group (X 2  (1, N=219)=7.19, p=0.007, φ=0.18).
CONCLUSIONS DRAWN AND CLINICAL IMPLICATIONS


Extra support in the form of a brief reminder message can increase the percentage of people who seek further medical attention after attending an opportunistic screening at a marathon event. The discussion reviews how the results align with previous research, strengths and limitations of the current study, and implications for future research and practice.",2020,"A McNemar analysis suggested that the screening increased participant awareness (X 2  (N =1227)=72.16, p<0.001).","['266 participants whose screening indicated hypertension (64 Female', '219 participants provided follow-up data via a phone call (82% retention', '1227 participants (529 female) was conducted during the registration period of the 2018 Beirut International Marathon in Lebanon']","['reminder prompt to seek further medical attention', 'Lebanon', 'opportunistic mobile screening']","['participant awareness', ""participants' self-reports of whether they sought further medical attention""]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C4517806', 'cui_str': '529'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0168374', 'cui_str': 'Marathon composite resin'}, {'cui': 'C0023190', 'cui_str': 'Lebanon'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023190', 'cui_str': 'Lebanon'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",219.0,0.0881207,"A McNemar analysis suggested that the screening increased participant awareness (X 2  (N =1227)=72.16, p<0.001).","[{'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Schmidtke', 'Affiliation': 'Medical School, Warwick Medical School, University of Warwick, United Kingdom.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Vlaev', 'Affiliation': 'Behavioural Science Group, Warwick Business School, University of Warwick, United Kingdom.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kabbani', 'Affiliation': 'Cardiology Department, Rafik Hariri University Hospital, Beirut, Lebanon.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Klauznicer', 'Affiliation': 'Supreme Committee for Delivery and Legacy, B4Development Foundation (formerly Qatar Behavioural Insights Unit), Doha, Qatar.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Baasiri', 'Affiliation': 'Nudge Lebanon, Beirut, Lebanon.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Osseiran', 'Affiliation': 'Nudge Lebanon, Beirut, Lebanon.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'El Rifai', 'Affiliation': 'Nudge Lebanon, Beirut, Lebanon.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Fares', 'Affiliation': 'Nudge Lebanon, Beirut, Lebanon.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Saleh', 'Affiliation': 'Nudge Lebanon, Beirut, Lebanon.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Makki', 'Affiliation': 'Supreme Committee for Delivery and Legacy, B4Development Foundation (formerly Qatar Behavioural Insights Unit), Doha, Qatar.'}]",International journal of clinical practice,['10.1111/ijcp.13669']
1974,32772460,Informing American Muslims about Living Donation Through Tailored Health Education: A Randomized Controlled Cross-Over Trial Evaluating Increase in Biomedical and Religious Knowledge.,"Biomedical and religious knowledge impacts organ donation attitudes among Muslims. We tested the effectiveness of mosque-based, religiously-tailored, ethically-balanced education on organ donation among Muslim Americans. Our randomized, controlled, cross-over trial took place at four mosques randomized to an early arm where organ donation education preceded a control educational workshop or a late arm with the order reversed. Primary outcomes were changes in biomedical (Rotterdam Renal Replacement Knowledge living donation subscale, R3KT) and religious (Islamic Knowledge of Living Organ Donation, IK-LOD) living kidney donation knowledge. Statistical analysis employed a 2 (Treatment Arm) X 3 (Time of Assessment) mixed-method ANOVA. Of 158 participants, 59 were in the early arm and 99 in the late arm. A between group t-test comparison at Period 1 (Time 1 - Time 2), demonstrated that the early arm had a significantly higher mean IK-LOD (7.11 v 5.19, p < 0.05) and R3KT scores (7.65 v 4.90, p < 0.05) when compared to the late arm. Late arm participants also had significant increases in mean IK-LOD (5.19 v 7.16, p < 0.05) and R3KT scores (4.90 v. 6.81, p <0.05) post-intervention (Time 2-Time 3). Our novel program thus yielded significant kidney donation-related knowledge gains among Muslim Americans [NCT04443114 Clinicaltrials.gov].",2020,Late arm participants also had significant increases in mean IK-LOD (,"['Muslim Americans', 'Of 158 participants, 59 were in the early arm and 99 in the late arm']","['mosque-based, religiously-tailored, ethically-balanced education', 'control educational workshop']","['mean IK-LOD', 'R3KT scores', 'mean IK-LOD ', 'changes in biomedical (Rotterdam Renal Replacement Knowledge living donation subscale, R3KT) and religious (Islamic Knowledge of Living Organ Donation, IK-LOD) living kidney donation knowledge']","[{'cui': 'C0022126', 'cui_str': 'Islam'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0562614', 'cui_str': 'Mosque'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2718050', 'cui_str': 'Limits of Detection'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1302112', 'cui_str': 'Renal replacement'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C0557075', 'cui_str': 'Has religious belief'}, {'cui': 'C0022126', 'cui_str': 'Islam'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0411257', 'cui_str': 'Donor nephrectomy'}]",158.0,0.0499988,Late arm participants also had significant increases in mean IK-LOD (,"[{'ForeName': 'Aasim I', 'Initials': 'AI', 'LastName': 'Padela', 'Affiliation': 'Initiative on Islam and Medicine, University of Chicago, USA.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Duivenbode', 'Affiliation': 'Initiative on Islam and Medicine, University of Chicago, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Quinn', 'Affiliation': 'Department of Medicine, University of Chicago Medical Center, USA.'}, {'ForeName': 'Milda R', 'Initials': 'MR', 'LastName': 'Saunders', 'Affiliation': 'MacLean Center for Clinical Medical Ethics, University of Chicago, USA.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16242']
1975,32771011,Scale-up of the Physical Activity 4 Everyone (PA4E1) intervention in secondary schools: 12-month implementation outcomes from a cluster randomized controlled trial.,"BACKGROUND


'Physical Activity 4 Everyone' (PA4E1) was an efficacious multi-component school-based physical activity (PA) program targeting adolescents. PA4E1 has seven PA practices. It is essential to scale-up, evaluate effectiveness and assess implementation of such programs. Therefore, the aim is to assess the impact of implementation support on school practice uptake of the PA4E1 program at 12 and 24 months.
METHODS


A cluster randomised controlled trial, utilising a type III hybrid implementation-effectiveness design, was conducted in 49 randomly selected disadvantaged Australian Government and Catholic secondary schools. A blinded statistician randomly allocated schools to a usual practice control (n = 25) or the PA4E1 program group (n = 24), with the latter receiving seven implementation support strategies to support school PA practice uptake of the seven practices retained from the efficacy trial. The primary outcome was the proportion of schools adopting at least four of the seven practices, assessed via telephone surveys with Head Physical Education Teachers and analysed using exact logistic regression modelling. This paper reports the 12-month outcomes.
RESULTS


Schools were recruited from May to November 2017. At baseline, no schools implemented four of the seven practices. At 12 months significantly more schools in the program group had implemented four of the seven practices (16/24, 66.7%) than the control group (1/25, 4%) (OR = 33.0[4.15-1556.4], p < 0.001). The program group implemented on average 3.2 (2.5-3.9) more practices than the control group (p < 0.001, mean 3.9 (SD 1.5) vs 0.7 (1.0)). Fidelity and reach of the implementation support intervention were high (both > 80%).
CONCLUSIONS


Through the application of multiple implementation support strategies, secondary schools were able to overcome commonly known barriers to implement evidence based school PA practices. As such practices have been shown to result in an increase in adolescent PA and improvements in weight status, policy makers and practitioners responsible for advocating PA in schools should consider this implementation approach more broadly when working with schools. Follow-up is required to determine whether practice implementation is sustained.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12617000681358 registered 12th May 2017.",2020,"The program group implemented on average 3.2 (2.5-3.9) more practices than the control group (p < 0.001, mean 3.9 (SD 1.5) vs 0.7 (1.0)).","['secondary schools', 'Schools were recruited from May to November 2017', '49 randomly selected disadvantaged Australian Government and Catholic secondary schools']","['Physical Activity 4 Everyone (PA4E1) intervention', 'usual practice control (n\u2009=\u200925) or the PA4E1 program', 'PA4E1']","['proportion of schools adopting at least four of the seven practices, assessed via telephone surveys with Head Physical Education Teachers']","[{'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0242211', 'cui_str': 'Roman Catholic, follower of religion'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]",49.0,0.0969577,"The program group implemented on average 3.2 (2.5-3.9) more practices than the control group (p < 0.001, mean 3.9 (SD 1.5) vs 0.7 (1.0)).","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Sutherland', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Campbell', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'McLaughlin', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia. Matthew.Mclaughlin1@health.nsw.gov.au.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Nathan', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Wolfenden', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lubans', 'Affiliation': 'Priority Research Centre in Physical Activity and Nutrition, School of Education, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Morgan', 'Affiliation': 'Priority Research Centre in Physical Activity and Nutrition, School of Education, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gillham', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Oldmeadow', 'Affiliation': 'Hunter Medical Research Institute, Newcastle, NSW, 2300, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Searles', 'Affiliation': 'Hunter Medical Research Institute, Newcastle, NSW, 2300, Australia.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Reeves', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, 2308, Australia.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'South Western Sydney Local Health District, Locked Mail Bag 7279, Liverpool BC, NSW, 1871, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Kajons', 'Affiliation': 'Central Coast Local Health District, 4-6 Watt Street, Gosford, NSW, 2250, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bailey', 'Affiliation': 'Mid North Coast Local Health District, P.O. Box 126, Port Macquarie, NSW, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Boyer', 'Affiliation': 'New South Wales Department of Education, School Sports Unit, Level 3, 1 Oxford Street, Darlinghurst, NSW, 2010, Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Davies', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'McKenzie', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Hollis', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wiggers', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-01000-y']
1976,32771013,Erythropoietin prevents necrotizing enterocolitis in very preterm infants: a randomized controlled trial.,"BACKGROUND


Necrotizing enterocolitis (NEC) is one of the most severe complications in very preterm infants, but there are currently no accepted methods to prevent NEC. Studies have shown that erythropoietin (EPO) has the potential to prevent NEC or improve outcomes of preterm NEC. This study aimed to determine whether recombinant human EPO (rhEPO) could protect against NEC in very preterm infants.
METHODS


The study was a prospective randomized clinical trial performed among four NICU centers. A total of 1327 preterm infants with gestational age ≤ 32 weeks were admitted to the centers, and 42 infants were excluded leaving 1285 eligible infants to be randomized to the rhEPO or control group. Infants in the rhEPO group were given 500 IU/kg rhEPO intravenously every other day for 2 weeks, while the control group was given the same volume of saline. The primary outcome was the incidence of NEC in very preterm infants at 36 weeks of corrected gestational age.
RESULTS


A total of 1285 infants were analyzed at 36 weeks of corrected age for the incidence of NEC. rhEPO treatment significantly decreased the incidence of NEC (stage I, II and III) (12.0% vs. 17.1%, p = 0.010), especially confirmed NEC (stage II and III) (3.0% vs. 5.4%, p = 0.027). Meanwhile, rhEPO treatment significantly reduced the number of red blood cells transfusion in the confirmed NEC cases (1.2 ± 0.4 vs. 2.7 ± 1.0, p = 0.004). Subgroup analyses showed that rhEPO treatment significantly decreased the incidence of confirmed NEC at gestational age < 28 weeks (p = 0.019), and the incidence of all stages NEC in preterm infants with hemoglobin < 90 g/l (p = 0.000) and 5 min Apgar score > 5 (p = 0.028).
CONCLUSION


Repeated low-dose rhEPO treatment is beneficial against NEC in very preterm infants. Trial registration The protocol was registered retrospectively at ClinicalTrials.gov (NCT03919500) on April 18, 2019. https://clinicaltrials.gov/ct2/show/NCT03919500.",2020,"/l (p = 0.000) and 5 min Apgar score > 5 (p = 0.028).
","['very preterm infants', 'preterm infants with hemoglobin <\u200990\xa0g', '1327 preterm infants with gestational age ≤\u200932\xa0weeks were admitted to the centers, and 42 infants were excluded leaving 1285 eligible infants', 'A total of 1285 infants were analyzed at 36\xa0weeks of corrected age for the incidence of NEC']","['Erythropoietin', 'recombinant human EPO (rhEPO', 'rhEPO', 'rhEPO or control group', 'erythropoietin (EPO']","['incidence of confirmed NEC', 'incidence of NEC (stage I, II and III', 'necrotizing enterocolitis', 'number of red blood cells transfusion', 'incidence of NEC']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}]","[{'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}]",1327.0,0.179091,"/l (p = 0.000) and 5 min Apgar score > 5 (p = 0.028).
","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Department of Neonatology, Institute of Neuroscience and Third Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Department of Neonatology, Institute of Neuroscience and Third Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Huiqing', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': ""Department of Neonatology, Children's Hospital of Zhengzhou University, Zhengzhou, 450018, China.""}, {'ForeName': 'Falin', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Department of Neonatology, Institute of Neuroscience and Third Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Kenan', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Department of Neonatology, Institute of Neuroscience and Third Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Chunxia', 'Initials': 'C', 'LastName': 'Nie', 'Affiliation': 'Department of Neonatology, Women and Children Health Care Center of Luoyang, Luoyang, 471000, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Department of Neonatology, Institute of Neuroscience and Third Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Xirui', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Department of Neonatology, Institute of Neuroscience and Third Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Department of Neonatology, Institute of Neuroscience and Third Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Ziyun', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': 'Department of Neonatology, First Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Department of Neonatology, Institute of Neuroscience and Third Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Department of Neonatology, Institute of Neuroscience and Third Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Ding', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Department of Neonatology, Institute of Neuroscience and Third Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Yaodong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Neonatology, Children's Hospital of Zhengzhou University, Zhengzhou, 450018, China.""}, {'ForeName': 'Wenqing', 'Initials': 'W', 'LastName': 'Kang', 'Affiliation': ""Department of Neonatology, Children's Hospital of Zhengzhou University, Zhengzhou, 450018, China.""}, {'ForeName': 'Liling', 'Initials': 'L', 'LastName': 'Qian', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Fudan University, Shanghai, China.""}, {'ForeName': 'Wenhao', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Fudan University, Shanghai, China.""}, {'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Department of Neonatology, Institute of Neuroscience and Third Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Xiuyong', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'Department of Neonatology, First Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Changlian', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Department of Neonatology, Institute of Neuroscience and Third Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China. changlian.zhu@neuro.gu.se.'}]",Journal of translational medicine,['10.1186/s12967-020-02459-w']
1977,32771017,Comparing a standard and tailored approach to scaling up an evidence-based intervention for antiretroviral therapy for people who inject drugs in Vietnam: study protocol for a cluster randomized hybrid type III trial.,"BACKGROUND


People who inject drugs (PWID) bear a disproportionate burden of HIV infection and experience poor outcomes. A randomized trial demonstrated the efficacy of an integrated System Navigation and Psychosocial Counseling (SNaP) intervention in improving HIV outcomes, including antiretroviral therapy (ART) and medications for opioid use disorder (MOUD) uptake, viral suppression, and mortality. There is limited evidence about how to effectively scale such intervention. This protocol presents a hybrid type III effectiveness-implementation trial comparing two approaches for scaling-up SNaP. We will evaluate the effectiveness of SNaP implementation approaches as well as cost and the characteristics of HIV testing sites achieving successful or unsuccessful implementation of SNaP in Vietnam.
METHODS


Design: In this cluster randomized controlled trial, two approaches to scaling-up SNaP for PWID in Vietnam will be compared. HIV testing sites (n = 42) were randomized 1:1 to the standard approach or the tailored approach. Intervention mapping was used to develop implementation strategies for both arms. The standard arm will receive a uniform package of these strategies, while implementation strategies for the tailored arm will be designed to address site-specific needs.
PARTICIPANTS


HIV-positive PWID participants (n = 6200) will be recruited for medical record assessment at baseline; of those, 1500 will be enrolled for detailed assessments at baseline, 12, and 24 months. Site directors and staff at each of the 42 HIV testing sites will complete surveys at baseline, 12, and 24 months.
OUTCOMES


Implementation outcomes (fidelity, penetration, acceptability) and effectiveness outcomes (ART, MOUD uptake, viral suppression) will be compared between the arms. To measure incremental costs, we will conduct an empirical costing study of each arm and the actual process of implementation from a societal perspective. Qualitative and quantitative site-level data will be used to explore key characteristics of HIV testing sites that successfully or unsuccessfully implement the intervention for each arm.
DISCUSSION


Scaling up evidence-based interventions poses substantial challenges. The proposed trial contributes to the field of implementation science by applying a systematic approach to designing and tailoring implementation strategies, conducting a rigorous comparison of two promising implementation approaches, and assessing their incremental costs. Our study will provide critical guidance to Ministries of Health worldwide regarding the most effective, cost-efficient approach to SNaP implementation.
TRIAL REGISTRATION


NCT03952520 on Clinialtrials.gov. Registered 16 May 2019.",2020,"OUTCOMES


Implementation outcomes (fidelity, penetration, acceptability) and effectiveness outcomes (ART, MOUD uptake, viral suppression) will be compared between the arms.","['People who inject drugs (PWID', 'HIV-positive PWID participants (n = 6200) will be recruited for medical record assessment at baseline; of those, 1500 will be enrolled for detailed assessments at baseline, 12, and 24 months', 'HIV testing sites (n = 42', 'people who inject drugs in Vietnam']","['standard and tailored approach to scaling up an evidence-based intervention for antiretroviral therapy', 'integrated System Navigation and Psychosocial Counseling (SNaP) intervention', 'scaling-up SNaP']","['Implementation outcomes (fidelity, penetration, acceptability) and effectiveness outcomes (ART, MOUD uptake, viral suppression', 'HIV outcomes, including antiretroviral therapy (ART) and medications for opioid use disorder (MOUD) uptake, viral suppression, and mortality']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C4517837', 'cui_str': '6200'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0841579', 'cui_str': 'Psychosocial counseling'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",6200.0,0.202582,"OUTCOMES


Implementation outcomes (fidelity, penetration, acceptability) and effectiveness outcomes (ART, MOUD uptake, viral suppression) will be compared between the arms.","[{'ForeName': 'Minh X B', 'Initials': 'MXB', 'LastName': 'Nguyen', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, 135 Dauer Dr, Chapel Hill, NC, 27599, USA. binhminh@live.unc.edu.'}, {'ForeName': 'Anh V', 'Initials': 'AV', 'LastName': 'Chu', 'Affiliation': 'University of North Carolina Project Vietnam, Lot E2 Duong Dinh Nghe St., Cau Giay, Hanoi, Vietnam.'}, {'ForeName': 'Byron J', 'Initials': 'BJ', 'LastName': 'Powell', 'Affiliation': 'Brown School, Washington University in St. Louis, One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Ha V', 'Initials': 'HV', 'LastName': 'Tran', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, 135 Dauer Dr, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Long H', 'Initials': 'LH', 'LastName': 'Nguyen', 'Affiliation': 'Vietnam Authority of HIV/AIDS Control, Land 8 That Thuyet St., Ba Dinh, Hanoi, Vietnam.'}, {'ForeName': 'An T M', 'Initials': 'ATM', 'LastName': 'Dao', 'Affiliation': 'Department of Epidemiology, Institute of Preventive Medicine and Public Health, 1 Ton That Tung St., Dong Da, Hanoi, Vietnam.'}, {'ForeName': 'Manh D', 'Initials': 'MD', 'LastName': 'Pham', 'Affiliation': 'Vietnam Authority of HIV/AIDS Control, Land 8 That Thuyet St., Ba Dinh, Hanoi, Vietnam.'}, {'ForeName': 'Son H', 'Initials': 'SH', 'LastName': 'Vo', 'Affiliation': 'Vietnam Authority of HIV/AIDS Control, Land 8 That Thuyet St., Ba Dinh, Hanoi, Vietnam.'}, {'ForeName': 'Ngoc H', 'Initials': 'NH', 'LastName': 'Bui', 'Affiliation': 'Department of Epidemiology, Institute of Preventive Medicine and Public Health, 1 Ton That Tung St., Dong Da, Hanoi, Vietnam.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dowdy', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe St, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Carl A', 'Initials': 'CA', 'LastName': 'Latkin', 'Affiliation': 'Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe St, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Lancaster', 'Affiliation': 'Department of Epidemiology, College of Public Health, Ohio State University, 250 Cunz Hall, 1841 Neil Ave, Columbus, OH, 43210, USA.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Pence', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, 135 Dauer Dr, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Teerada', 'Initials': 'T', 'LastName': 'Sripaipan', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, 135 Dauer Dr, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Irving', 'Initials': 'I', 'LastName': 'Hoffman', 'Affiliation': 'Division of Infectious Diseases, UNC School of Medicine, 321 S Columbia St, Chapel Hill, NC, 27516, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Miller', 'Affiliation': 'Department of Epidemiology, College of Public Health, Ohio State University, 250 Cunz Hall, 1841 Neil Ave, Columbus, OH, 43210, USA.'}, {'ForeName': 'Vivian F', 'Initials': 'VF', 'LastName': 'Go', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, 135 Dauer Dr, Chapel Hill, NC, 27599, USA. vgo@live.unc.edu.'}]",Implementation science : IS,['10.1186/s13012-020-01020-z']
1978,32771018,Effect of novel technology-enabled multidimensional physical activity feedback in primary care patients at risk of chronic disease - the MIPACT study: a randomised controlled trial.,"BACKGROUND


Technological progress has enabled the provision of personalised feedback across multiple dimensions of physical activity that are important for health. Whether this multidimensional approach supports physical activity behaviour change has not yet been examined. Our objective was to examine the effectiveness of a novel digital system and app that provided multidimensional physical activity feedback combined with health trainer support in primary care patients identified as at risk of chronic disease.
METHODS


MIPACT was a parallel-group, randomised controlled trial that recruited patients at medium (≥10 and < 20%) or high (≥20%) risk of cardiovascular disease and/or type II diabetes from six primary care practices in the United Kingdom. Intervention group participants (n = 120) received personal multidimensional physical activity feedback using a customised digital system and web-app for 3 months plus five health trainer-led sessions. All participants received standardised information regarding physical activity. Control group participants (n = 84) received no further intervention. The primary outcome was device-based assessment of physical activity at 12 months.
RESULTS


Mean intervention effects were: moderate-vigorous physical activity: -1.1 (95% CI, - 17.9 to 15.7) min/day; moderate-vigorous physical activity in ≥10-min bouts: 0.2 (- 14.2 to 14.6) min/day; Physical Activity Level (PAL): 0.00 (- 0.036 to 0.054); vigorous physical activity: 1.8 (- 0.8 to 4.2) min/day; and sedentary time: 10 (- 19.3 to 39.3) min/day. For all of these outcomes, the results showed that the groups were practically equivalent and statistically ruled out meaningful positive or negative effects (>minimum clinically important difference, MCID). However, there was profound physical activity multidimensionality, and only a small proportion (5%) of patients had consistently low physical activity across all dimensions.
CONCLUSION


In patients at risk of cardiovascular disease and/or type II diabetes, MIPACT did not increase mean physical activity. Using a sophisticated multidimensional digital approach revealed enormous heterogeneity in baseline physical activity in primary care patients, and practitioners may need to screen for low physical activity across dimensions rather than rely on disease-risk algorithms that are heavily influenced by age.
TRIAL REGISTRATION


This trial is registered with the ISRCTN registry ( ISRCTN18008011 ; registration date 31 July 2013).",2020,"For all of these outcomes, the results showed that the groups were practically equivalent and statistically ruled out meaningful positive or negative effects (>minimum clinically important difference, MCID).","['recruited patients at medium (≥10 and\u2009<\u200920%) or high (≥20%) risk of cardiovascular disease and/or type II diabetes from six primary care practices in the United Kingdom', 'primary care patients at risk of chronic disease - the MIPACT study', 'primary care patients identified as at risk of chronic disease', 'primary care patients, and practitioners']","['novel technology-enabled multidimensional physical activity feedback', 'novel digital system and app that provided multidimensional physical activity feedback combined with health trainer support', 'personal multidimensional physical activity feedback using a customised digital system and web-app for 3\u2009months plus five health trainer-led sessions']","['vigorous physical activity', 'physical activity multidimensionality', 'Physical Activity Level (PAL', 'mean physical activity', 'moderate-vigorous physical activity', 'device-based assessment of physical activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030360', 'cui_str': 'Papillon-Lefèvre syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0998878,"For all of these outcomes, the results showed that the groups were practically equivalent and statistically ruled out meaningful positive or negative effects (>minimum clinically important difference, MCID).","[{'ForeName': 'Oliver J', 'Initials': 'OJ', 'LastName': 'Peacock', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Max J', 'Initials': 'MJ', 'LastName': 'Western', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Batterham', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, UK.'}, {'ForeName': 'Enhad A', 'Initials': 'EA', 'LastName': 'Chowdhury', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Afroditi', 'Initials': 'A', 'LastName': 'Stathi', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Standage', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Tapp', 'Affiliation': 'Bristol Business School, University of West of England, Bristol, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bennett', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK. d.thompson@bath.ac.uk.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-00998-5']
1979,32776722,Performance of a Community-based Noncommunicable Disease Control Program in Korea: Patients 65 Years of Age or Older.,"BACKGROUND


In Korea, the Korean Community-based Noncommunicable Disease Prevention and Control Program (KCNPC) was implemented in 2012 for the management of patients with chronic diseases. Nineteen primary care clinics, public health centers, and education and consulting centers (ECCs) participated in the implementation of this program. This study assessed the effectiveness of this chronic disease control model by comparing mortality rate and the incidence of complications between patients participating in the KCNPC program and a control group.
METHODS


Using data from the National Health Insurance Service and data from hypertension and diabetes patients registered with 19 ECCs between January 1, 2010 and December 31, 2012, hypertension and diabetes patients who had been treated at a clinic were selected. The final analysis included 252,900 patients, with the intervention group and control group having 126,450 patients each. Survival for the two groups was analyzed using the Kaplan-Meier method. Complications were analyzed using the Cox proportional hazards model.
RESULTS


The 5-year survival rate in the intervention group (0.88) was higher than that in the control group (0.86). Cox proportional hazards analysis showed that the intervention group had lower risk for mortality (0.84; 95% confidence interval [CI], 0.82-0.86) compared to the control group. Hospitalization due to complications and the proportional risk of hospitalization were also lower in the intervention group.
CONCLUSION


The KCNPC model for prevention and control of chronic disease in Korea was found to be effective for hypertension and diabetes patients. Therefore, the KCNPC will be necessary to strengthen the capabilities of local communities, primary medical institutions, and individuals for prevention and control of chronic disease. Expanding the efficient prevention and control policies of the KCNPC to a nationwide scale may be effective as has been demonstrated through limited implementation in some regions.",2020,The KCNPC model for prevention and control of chronic disease in Korea was found to be effective for hypertension and diabetes patients.,"['Korea: Patients 65 Years of Age or Older', 'patients registered with 19 ECCs between January 1, 2010 and December 31, 2012, hypertension and diabetes patients who had been treated at a clinic were selected', 'Nineteen primary care clinics, public health centers, and education and consulting centers (ECCs) participated in the implementation of this program', '252,900 patients, with the intervention group and control group having 126,450 patients each', 'patients with chronic diseases', 'Using data from the National Health Insurance Service and data from hypertension and diabetes', 'patients participating in the KCNPC program and a control group']","['Community-based Noncommunicable Disease Control Program', 'Control Program (KCNPC', 'KCNPC']","['5-year survival rate', 'Survival', 'lower risk for mortality', 'mortality rate and the incidence of complications', 'proportional risk of hospitalization']","[{'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0585825', 'cui_str': 'Patient registered'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0027452', 'cui_str': 'National Health Insurance'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4505065', 'cui_str': 'Non-infectious Diseases'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4505065', 'cui_str': 'Non-infectious Diseases'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",252900.0,0.0179266,The KCNPC model for prevention and control of chronic disease in Korea was found to be effective for hypertension and diabetes patients.,"[{'ForeName': 'Sun Mi', 'Initials': 'SM', 'LastName': 'Lim', 'Affiliation': 'Department of Preventive Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Sung Hyo', 'Initials': 'SH', 'LastName': 'Seo', 'Affiliation': 'Department of Information Statistics, Gyeongsang National University, Jinju, Korea.'}, {'ForeName': 'Ki Soo', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Department of Preventive Medicine, College of Medicine and Institute of Health Science, Gyeongsang National University, Jinju, Korea.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Hwangbo', 'Affiliation': 'Department of Preventive Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Yeonok', 'Initials': 'Y', 'LastName': 'Suh', 'Affiliation': 'Department of Nursing, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Sungin', 'Initials': 'S', 'LastName': 'Ji', 'Affiliation': 'Department of Preventive Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Jeongmook', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Department of Preventive Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Hyeonji', 'Initials': 'H', 'LastName': 'Hwang', 'Affiliation': 'Department of Preventive Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Jose Rene Bagani', 'Initials': 'JRB', 'LastName': 'Cruz', 'Affiliation': 'Department of Preventive Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Yoon Hyung', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Department of Preventive Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea. parky@sch.ac.kr.'}]",Journal of Korean medical science,['10.3346/jkms.2020.35.e268']
1980,32776763,"Physical therapy, intra-articular dextrose prolotherapy, botulinum neurotoxin, and hyaluronic acid for knee osteoarthritis: randomized clinical trial.","This study aimed to compare the efficacy of four treatments in the management of knee osteoarthritis. We carried out a randomized clinical trial with four study arms in an outpatient Department of Physical Medicine and Rehabilitation at a University Hospital. In total, 120 patients with knee osteoarthritis ≥50 years of age were randomly allocated to four groups. The primary outcome was knee pain in visual analog scale and the secondary outcome was the Knee Injury and Osteoarthritis Outcome Score. The exercise was prescribed daily for all participants throughout the study. For physical therapy (group 1), participants received superficial heat, transcutaneous electrical nerve stimulation and pulsed ultrasound. We administered a single intra-articular injection of botulinum neurotoxin type A (group 2) and three injections of hyaluronic acid (group 3) or 20% dextrose (group 4) to patients in the corresponding groups. Mixed analysis of variance showed that there was statistically significant difference between the groups in pain (P < 0.001), and Knee Injury and Osteoarthritis Outcome Score (P < 0.001). Pairwise between- and within-group comparisons showed that botulinum neurotoxin and dextrose prolotherapy were the most, and hyaluronic acid was the least efficient treatments for controlling pain and recovering function in patients. An intra-articular injection of botulinum toxin type A or dextrose prolotherapy is effective first-line treatments. In the next place stands physical therapy particularly if the patient is not willing to continue regular exercise programs. Our study was not very supportive of intra-articular injection of hyaluronic acid as an effective treatment of knee osteoarthritis.",2020,"Mixed analysis of variance showed that there was statistically significant difference between the groups in pain (P < 0.001), and Knee Injury and Osteoarthritis Outcome Score (P < 0.001).","['knee osteoarthritis', 'four study arms in an outpatient Department of Physical Medicine and Rehabilitation at a University Hospital', '120 patients with knee osteoarthritis ≥50 years of age']","['Physical therapy, intra-articular dextrose prolotherapy, botulinum neurotoxin, and hyaluronic acid', 'botulinum neurotoxin and dextrose prolotherapy', 'physical therapy', 'hyaluronic acid', 'botulinum toxin type A or dextrose prolotherapy', 'hyaluronic acid (group 3) or 20% dextrose', 'superficial heat, transcutaneous electrical nerve stimulation and pulsed ultrasound', 'botulinum neurotoxin type A']","['knee pain in visual analog scale', 'Knee Injury and Osteoarthritis Outcome Score', 'pain']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0031813', 'cui_str': 'Physical Medicine and Rehabilitation'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0500223', 'cui_str': 'Prolotherapy'}, {'cui': 'C1295507', 'cui_str': 'Bontoxilysin'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C2143225', 'cui_str': 'Pulsed Ultrasound'}]","[{'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",120.0,0.0697498,"Mixed analysis of variance showed that there was statistically significant difference between the groups in pain (P < 0.001), and Knee Injury and Osteoarthritis Outcome Score (P < 0.001).","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Rezasoltani', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Aja University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sirous', 'Initials': 'S', 'LastName': 'Azizi', 'Affiliation': ''}, {'ForeName': 'Sharif', 'Initials': 'S', 'LastName': 'Najafi', 'Affiliation': ''}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Sanati', 'Affiliation': ''}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Dadarkhah', 'Affiliation': ''}, {'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Abdorrazaghi', 'Affiliation': ''}]",International journal of rehabilitation research. Internationale Zeitschrift fur Rehabilitationsforschung. Revue internationale de recherches de readaptation,['10.1097/MRR.0000000000000411']
1981,32776764,Effects of prism adaptation on auditory spatial attention in patients with left unilateral spatial neglect: a non-randomized pilot trial.,"A short period of adaptation to a prismatic shift of the visual field to the right briefly but significantly improves left unilateral spatial neglect. Additionally, prism adaptation affects multiple modalities, including processes of vision, auditory spatial attention, and sound localization. This non-randomized, single-center, controlled trial aimed to examine the immediate effects of prism adaptation on the sound-localization abilities of patients with left unilateral spatial neglect using a simple source localization test. Subjects were divided by self-allocation into a prism-adaptation group (n = 11) and a control group (n = 12). At baseline, patients with left unilateral spatial neglect showed a rightward deviation tendency in the left space. This tendency to right-sided bias in the left space was attenuated after prism adaptation. However, no changes were observed in the right space of patients with left unilateral spatial neglect after prism adaptation, or in the control group. Our results suggest that prism adaptation improves not only vision and proprioception but also auditory attention in the left space of patients with left unilateral spatial neglect. Our findings demonstrate that a single session of prism adaptation can significantly improve sound localization in patients with left unilateral spatial neglect. However, in this study, it was not possible to accurately determine whether the mechanism was a chronic change in head orientation or a readjustment of the spatial representation of the brain; thus, further studies need to be considered.",2020,"However, no changes were observed in the right space of patients with left unilateral spatial neglect after prism adaptation, or in the control group.","['patients with left unilateral spatial neglect', 'patients with left unilateral spatial neglect using a simple source localization test']",['prism adaptation'],"['left unilateral spatial neglect', 'processes of vision, auditory spatial attention, and sound localization', 'auditory spatial attention', 'rightward deviation tendency', 'sound localization', 'vision and proprioception']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0000934', 'cui_str': 'Acclimation'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}]",12.0,0.0397233,"However, no changes were observed in the right space of patients with left unilateral spatial neglect after prism adaptation, or in the control group.","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Matsuo', 'Affiliation': 'aUnit of Medical Sciences, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki bFaculty of Rehabilitation Sciences, Nishikyushu University, Saga cDivision of Occupational Therapy, Department of Rehabilitation, Faculty of Health Sciences, Saitama dWajinkai Medical Corporation, Wajinkai Hospital, Nagasaki eDivision of Occupational Therapy, Department of Rehabilitation, Faculty of Health Science, Kumamoto Health Science University, Kumamoto fSchool of Health Sciences, Faculty of Medicine, Kagoshima University, Kagoshima gDepartment of Physical Therapy, Faculty of Medical Science, Fukuoka International University of Health and Welfare, Fukuoka hSeibindo Medical Corporation, Shiroishi Kyoritsu Hospital, Saga, Japan.'}, {'ForeName': 'Takefumi', 'Initials': 'T', 'LastName': 'Moriuchi', 'Affiliation': ''}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Iso', 'Affiliation': ''}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Hasegawa', 'Affiliation': ''}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Miyata', 'Affiliation': ''}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Maruta', 'Affiliation': ''}, {'ForeName': 'Tsubasa', 'Initials': 'T', 'LastName': 'Mitsutake', 'Affiliation': ''}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Yamaguchi', 'Affiliation': ''}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Tabira', 'Affiliation': ''}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Higashi', 'Affiliation': ''}]",International journal of rehabilitation research. Internationale Zeitschrift fur Rehabilitationsforschung. Revue internationale de recherches de readaptation,['10.1097/MRR.0000000000000413']
1982,32771909,Implementation science outcomes of a gender-focused HIV and alcohol risk-reduction intervention in usual-care settings in South Africa.,"BACKGROUND


South Africa has the highest HIV prevalence globally, which disproportionately affects women. Hazardous alcohol use reduces antiretroviral adherence which can lead to adverse health. Few evidence-based interventions addressing hazardous alcohol use and HIV have been implemented in real-world settings. This study aimed to evaluate implementation outcomes from the Women's Health CoOp (WHC)-an evidence-based gender-focused HIV intervention-which was implemented in Cape Town.
METHODS


We conducted this implementation science trial using a modified stepped-wedge design. Four health clinics were paired with four substance use rehabilitation programs and randomized into four cycles. Women living with HIV and who use alcohol or other drugs were recruited into each cycle (n = 120 each cycle). We assessed adoption, acceptability, appropriateness, cost, and fidelity using a mixed methods approach.
RESULTS


Adoption: 100 % of staff trained in the WHC and designated as interventionists delivered one or more workshops. Acceptability: Interventionists found the WHC content beneficial to their patients and the WHC improved connections between clinical units in facilities. Appropriateness: The WHC aligned with facility goals to improve antiretroviral adherence and reduce alcohol use; however, there were implementation challenges, including staff shortages, stigma, and few places to refer women for supportive services. Cost: The cost of implementing the WHC was 20.59 ZAR (1.40 USD) per attendee. Fidelity: Interventionists implemented the WHC with high fidelity and quality.
CONCLUSIONS


The findings suggest it is feasible to integrate the WHC into usual-care settings. Future efforts to scale up the intervention will need to address social and structural implementation challenges.
TRIAL REGISTRATION


NCT02733003 approved 1/21/2016.",2020,Women living with HIV and who use alcohol or other drugs were recruited into each cycle (n = 120 each cycle).,"[""Women's Health CoOp (WHC)-an evidence-based gender-focused HIV intervention-which was implemented in Cape Town"", 'usual-care settings in South Africa', 'Women living with HIV and who use alcohol or other drugs were recruited into each cycle (n = 120 each cycle', 'Four health clinics']",['gender-focused HIV and alcohol risk-reduction intervention'],"['Acceptability', 'Fidelity', 'adoption, acceptability, appropriateness, cost, and fidelity', 'antiretroviral adherence', 'Cost', 'cost of implementing the WHC']","[{'cui': 'C0080339', 'cui_str': ""Woman's Health""}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0080339', 'cui_str': ""Woman's Health""}]",,0.0625822,Women living with HIV and who use alcohol or other drugs were recruited into each cycle (n = 120 each cycle).,"[{'ForeName': 'Margaret W', 'Initials': 'MW', 'LastName': 'Gichane', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA.'}, {'ForeName': 'Wendee M', 'Initials': 'WM', 'LastName': 'Wechsberg', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA; Gillings School of Global Public Health, University of North Carolina at Chapel Hill, CB #7445, Chapel Hill, NC, 27599, USA; Department of Psychology, North Carolina State University, 2310 Katharine Stinson Drive Raleigh, Raleigh, NC, 27607, USA; Psychiatry and Behavioral Sciences, Duke University School of Medicine, 40 Duke Medicine Circle, Durham, NC, 27710, USA. Electronic address: wmw@rti.org.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Ndirangu', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA.'}, {'ForeName': 'Felicia A', 'Initials': 'FA', 'LastName': 'Browne', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA; Gillings School of Global Public Health, University of North Carolina at Chapel Hill, CB #7445, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Courtney Peasant', 'Initials': 'CP', 'LastName': 'Bonner', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Grimwood', 'Affiliation': ""Kheth'Impilo AIDS Free Living, 11th Floor, Metlife Centre, 7 Walter Sisulu Avenue, Cape Town, 8000, South Africa.""}, {'ForeName': 'Najma', 'Initials': 'N', 'LastName': 'Shaikh', 'Affiliation': ""Kheth'Impilo AIDS Free Living, 11th Floor, Metlife Centre, 7 Walter Sisulu Avenue, Cape Town, 8000, South Africa.""}, {'ForeName': 'Brittni', 'Initials': 'B', 'LastName': 'Howard', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Zule', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108206']
1983,32771983,Randomised clinical trial of a gastrointestinal care bundle to reduce symptoms in patients with pelvic cancer undergoing chemoradiotherapy.,"OBJECTIVE


Pelvic radiotherapy is used to treat 17 000 people in the UK each year. Eight in 10 develop difficult bowel problems during pelvic treatment, especially diarrhoea, urgency and incontinence. Some cannot complete treatment, reducing the chance of cancer cure. Undertaking gastroenterologist-led investigation and management during pelvic radiotherapy has never been evaluated. In this study, we aimed to assess whether patients could successfully receive a novel gastrointestinal (GI) care bundle during chemoradiotherapy (feasibility aim) and would experience reduced symptom severity (clinical impact aim).
DESIGN


This randomised controlled trial recruited patients with cervical and bladder cancers undergoing radical chemoradiotherapy. Participants were randomised to intervention or control groups. Questionnaire and anthropometric data were collected. All intervention group patients received individualised dietary counselling weekly throughout treatment, and if bowel symptoms developed they were offered rapid-access investigation and treatment for any identified pathology: lactose intolerance, bacterial overgrowth or bile acid malabsorption.
RESULTS


Feasibility: 50 participants were recruited, 24 were randomised to the intervention group and 26 to the control group. All completed 20 fractions of external beam pelvic radiotherapy. It was possible to perform 57/72 (79%) of proposed intervention tests with no disruption of oncological management.
CLINICAL IMPACT


All participants developed GI symptoms during radiotherapy. The median symptom score for each group increased from baseline at 6 weeks. This was from 0.156 (0.000-0.333) to 0.600 (0.250-1.286) in the control group, and from 0.00 (0.000-0.300) to 0.402 (0.000-0.667) in the intervention group.
CONCLUSION


It was feasible to recruit to and deliver a randomised controlled trial of interventions in patients undergoing pelvic chemoradiotherapy. Lower median bowel scores were reported in the intervention group at 6 weeks, with fewer patients experiencing symptoms overall.
TRIAL REGISTRATION NUMBER


ISRCTN783488.",2020,"It was possible to perform 57/72 (79%) of proposed intervention tests with no disruption of oncological management.
","['17\u2009000 people in the UK each year', 'patients with pelvic cancer undergoing chemoradiotherapy', 'patients with cervical and bladder cancers undergoing', 'patients undergoing pelvic chemoradiotherapy']","['external beam pelvic radiotherapy', 'individualised dietary counselling weekly throughout treatment, and if bowel symptoms developed they were offered rapid-access investigation and treatment for any identified pathology: lactose intolerance, bacterial overgrowth or bile acid malabsorption', 'Pelvic radiotherapy', 'radical chemoradiotherapy', 'novel gastrointestinal (GI) care bundle during chemoradiotherapy']","['diarrhoea, urgency and incontinence', 'chance of cancer cure', 'GI symptoms', 'median symptom score', 'Lower median bowel scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751416', 'cui_str': 'Pelvic Cancer'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0022951', 'cui_str': 'Intolerance to lactose'}, {'cui': 'C0151521', 'cui_str': 'Bacterial resistance'}, {'cui': 'C2747802', 'cui_str': 'Bile acid malabsorption'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3658308', 'cui_str': 'Care Bundles'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}]",50.0,0.185933,"It was possible to perform 57/72 (79%) of proposed intervention tests with no disruption of oncological management.
","[{'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'White', 'Affiliation': 'Gastroenterology, Manchester Foundation Trust, Wythenshawe Hospital, Manchester, UK.'}, {'ForeName': 'Caroline C', 'Initials': 'CC', 'LastName': 'Henson', 'Affiliation': 'Gastroenterology, Manchester Foundation Trust, Wythenshawe Hospital, Manchester, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hann', 'Affiliation': 'Manchester Academic Health Sciences Centre, Health Innovation Manchester, Manchester, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Eden', 'Affiliation': 'Manchester Academic Health Sciences Centre, Health Innovation Manchester, Manchester, UK.'}, {'ForeName': 'Sorrel T', 'Initials': 'ST', 'LastName': 'Burden', 'Affiliation': 'Manchester Academic Health Sciences Centre, Health Innovation Manchester, Manchester, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Lal', 'Affiliation': 'Manchester Academic Health Sciences Centre, Health Innovation Manchester, Manchester, UK.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Davidson', 'Affiliation': 'Manchester Academic Health Sciences Centre, Health Innovation Manchester, Manchester, UK.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'McLaughlin', 'Affiliation': 'Manchester Academic Health Sciences Centre, Health Innovation Manchester, Manchester, UK John.Mclaughlin@manchester.ac.uk.'}]",BMJ open gastroenterology,['10.1136/bmjgast-2020-000432']
1984,32771996,Influence of Valve Type and Antiplatelet Regimen on Platelet Reactivity After TAVI: Subanalysis of the REAC-TAVI Trial.,"OBJECTIVES


Ticagrelor has proven more effective than clopidogrel at attaining a maintained suppression of high platelet reactivity (HPR) in aortic stenosis patients undergoing transcatheter aortic valve implantation (TAVI). This study aims to assess the influence of implanted valve type on the degree of platelet reactivity (PR) after TAVI.
METHODS


This study is a prespecified analysis of REAC-TAVI, a prospective, multicenter study that included patients on dual-antiplatelet therapy with aspirin and clopidogrel before TAVI. Patients with HPR (n = 48) were randomized to aspirin and clopidogrel or aspirin and ticagrelor for 3 months, while those without HPR (n = 20) were continued on aspirin and clopidogrel. PR was measured 6 hours, 24 hours, 5 days, 30 days, and 90 days after TAVI with VerifyNow assay. Bioprosthetic valves were classified as balloon-expandable valve (BEV), self-expandable valve (SEV), or other.
RESULTS


Sixty-eight patients comprising 32 BEVs, 28 SEVs, and 8 other valves were included. Devices were larger and postdilation was more frequent in the SEV group. Follow-up PR was lower in patients treated with ticagrelor vs those treated with clopidogrel at all time points after TAVI, including patients without baseline HPR (P<.001). PR after TAVI was similar in the three groups. Major cardiovascular adverse events, stroke, and hemorrhagic complications were comparable across the different bioprosthesis groups at 4-month follow-up.
CONCLUSIONS


The effect of valve type on PR after TAVI is similar across the spectrum of most transcatheter valves. In our sample, ticagrelor achieved a faster and more effective reduction in PR than clopidogrel in patients with HPR undergoing TAVI, irrespective of valve type.",2020,"Follow-up PR was lower in patients treated with ticagrelor vs those treated with clopidogrel at all time points after TAVI, including patients without baseline HPR (P<.001).","['included patients on dual-antiplatelet therapy with aspirin and clopidogrel before TAVI', 'patients with HPR undergoing TAVI, irrespective of valve type', 'Sixty-eight patients comprising 32 BEVs, 28 SEVs, and 8 other valves were included', 'Patients with HPR (n = 48', 'aortic stenosis patients undergoing transcatheter aortic valve implantation (TAVI']","['Ticagrelor', 'aspirin and clopidogrel or aspirin and ticagrelor', 'aspirin and clopidogrel', 'TAVI', 'clopidogrel', 'ticagrelor']","['platelet reactivity (PR', 'Platelet Reactivity', 'Major cardiovascular adverse events, stroke, and hemorrhagic complications']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}]","[{'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",48.0,0.0342596,"Follow-up PR was lower in patients treated with ticagrelor vs those treated with clopidogrel at all time points after TAVI, including patients without baseline HPR (P<.001).","[{'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Trejo-Velasco', 'Affiliation': ''}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Cruz-González', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Tello-Montoliu', 'Affiliation': ''}, {'ForeName': 'Jose Antonio', 'Initials': 'JA', 'LastName': 'Baz-Alonso', 'Affiliation': ''}, {'ForeName': 'Pablo Juan', 'Initials': 'PJ', 'LastName': 'Salvadores', 'Affiliation': ''}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Moreno', 'Affiliation': ''}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Romaguera', 'Affiliation': ''}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Molina-Navarro', 'Affiliation': ''}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Paredes-Galán', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'De-Miguel-Castro', 'Affiliation': ''}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Bastos-Fernandez', 'Affiliation': ''}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Ortiz-Saez', 'Affiliation': ''}, {'ForeName': 'Saleta', 'Initials': 'S', 'LastName': 'Fernández-Barbeira', 'Affiliation': ''}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Iñiguez-Romo', 'Affiliation': ''}, {'ForeName': 'Victor Alfonso', 'Initials': 'VA', 'LastName': 'Jimenez-Diaz', 'Affiliation': 'Cardiovascular Research Unit & Cardiology Department, Hospital Álvaro Cunqueiro, University Hospital of Vigo, Estrada de Clara Campoamor, 341, 36312, Vigo, Spain. sooner_79@hotmail.com or victor.alfonso.jimenez.diaz@sergas.es.'}]",The Journal of invasive cardiology,[]
1985,32772019,A Proactive Mobile Health Application Program for Promoting Self-Care Health Management among Older Adults in the Community: Study Protocol of a Three-Arm Randomized Controlled Trial.,"BACKGROUND


The use of mobile health (mHealth) has become common in recent years and is regarded as one of the most effective interventions for developing disease-specific management skills and establishing confidence in making preventive health behavior changes and accomplishing health-related goals among community-dwelling older adults. Most mHealth designs adopt a reactive care approach whereby health care professionals do not respond until they receive abnormal assessment results from the database or a message or signal from the client. The purpose of this study is to determine the effectiveness of a proactive mobile health application program with the support of a community health-social care team for older adults dwelling in the community on improving their self-care health management.
METHODS


This is a three-armed, randomized controlled trial. The study will be conducted in 7 community centers with an estimated sample size of 282 participants. The participants will be randomly assigned to mHealth with interactivity, mHealth, and control groups when they are (1) aged 60 or above, (2) complaining chiefly of pain, hypertension, or diabetes mellitus, (3) living within the service areas, and (4) smartphone users. Subjects in the mHealth with interactivity group will receive 2 main elements, the mHealth application and nurse case management supported by a social service team. The mHealth group will receive the mHealth application only. The primary outcome measure will be self-efficacy, and secondary outcomes will include self-management outcomes (pain score, blood pressure, capillary blood glucose), client outcomes (quality of life, depression), and health service utilization outcomes (institutionalization and health service utilization [general practitioner, outpatient clinic, emergency room, hospital admission]). Data will be collected before intervention, after intervention, and 3 months after intervention.
DISCUSSION


The incremental benefits of adding interactivity in the mHealth program have not been confirmed. This present study will add valuable information to the knowledge gap of whether mHealth with nurse interaction supported by a health-social partnership can improve self-care management among community-dwelling older adults.",2020,"Subjects in the mHealth with interactivity group will receive 2 main elements, the mHealth application and nurse case management supported by a social service team.","['Older Adults in the Community', '7 community centers with an estimated sample size of 282 participants', 'community-dwelling older adults', 'older adults dwelling in the community on improving their self-care health management', 'groups when they are (1) aged 60 or above, (2) complaining chiefly of pain, hypertension, or diabetes mellitus, (3) living within the service areas, and (4) smartphone users']","['mHealth application and nurse case management supported by a social service team', 'proactive mobile health application program', 'Proactive Mobile Health Application Program', 'mHealth with interactivity, mHealth, and control']","['self-efficacy, and secondary outcomes will include self-management outcomes (pain score, blood pressure, capillary blood glucose), client outcomes (quality of life, depression), and health service utilization outcomes (institutionalization and health service utilization [general practitioner, outpatient clinic, emergency room, hospital admission']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0085971', 'cui_str': 'Case management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0021629', 'cui_str': 'Institutionalization'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",282.0,0.0681252,"Subjects in the mHealth with interactivity group will receive 2 main elements, the mHealth application and nurse case management supported by a social service team.","[{'ForeName': 'Arkers Kwan Ching', 'Initials': 'AKC', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China, arkers.wong@polyu.edu.hk.'}, {'ForeName': 'Frances Kam Yuet', 'Initials': 'FKY', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Katherine Ka Pik', 'Initials': 'KKP', 'LastName': 'Chang', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China.'}]",Gerontology,['10.1159/000509129']
1986,32772063,"The change in the intensity of symptoms in children and adolescents with attention deficit hyperactivity disorder after ""Workshops for Parents of Hyperactive Children"".","OBJECTIVES


To evaluate changes in the intensity of ADHD symptoms and size effects after the completion of the twelve-week ""Workshops for Parents of Hyperactive Children"".
METHODS


Intervention group included parents (N = 199) of children and adolescents diagnosed with ADHD, who completed the twelve-week parental training. The reference group included parents (N = 24) of children and adolescents diagnosed with ADHD, who received 1-2 standard psychiatric visits within twelve weeks (treatment-as-usual). The following questionnaires were completed by the participants at the beginning and at the end of the training: CBCLand Conners-IOWA-10 (parent's assessment of the child), TRF and Conners-RCTRS-28 (assessment of the child by the teacher/educator), and YSR (in children of 11 years and over). The same diagnostic regime was used in the reference group - the patients were assessed during the first visit and after twelve weeks.
RESULTS


The majority of attendees were parents of boys diagnosed with: ADHD mixed type with or without ODD and ADHD predominantly inattentive type. The intervention resulted in significant reduction of inattentive-impulsive-hyperactive and oppositional-defiant symptoms in Conners-IOWA-10 and significant reduction of symptoms in the following CBCL scales: ""Social problems"", ""Attention problems"", ""Aggressive behavior"", ""Externalizing behavior"", as well as the overall score, as rated by mothers. The improvement was age, diagnosis and pharmacotherapy independent.
CONCLUSIONS


The therapeutic program used in our study resulted in small to moderate reduction of symptoms in children and adolescents with attention deficit hyperactivity disorder irrespective of subtype, comorbid disorders or pharmacotherapy (if implemented).",2020,"The intervention resulted in significant reduction of inattentive-impulsive-hyperactive and oppositional-defiant symptoms in Conners-IOWA-10 and significant reduction of symptoms in the following CBCL scales: ""Social problems"", ""Attention problems"", ""Aggressive behavior"", ""Externalizing behavior"", as well as the overall score, as rated by mothers.","['Intervention group included parents (N = 199) of children and adolescents diagnosed with ADHD, who completed the twelve-week parental training', 'children and adolescents with attention deficit hyperactivity disorder irrespective of subtype, comorbid disorders or pharmacotherapy (if implemented', 'Parents of Hyperactive Children', 'attendees were parents of boys diagnosed with: ADHD mixed type with or without ODD and ADHD predominantly inattentive type', 'reference group included parents (N = 24) of children and adolescents diagnosed with ADHD, who received 1-2 standard psychiatric visits within twelve weeks (treatment-as-usual', 'children and adolescents with attention deficit hyperactivity disorder after']","['TRF and Conners-RCTRS-28 (assessment of the child by the teacher/educator), and YSR', 'Workshops']","['CBCL scales: ""Social problems"", ""Attention problems"", ""Aggressive behavior"", ""Externalizing behavior', 'intensity of symptoms', 'inattentive-impulsive-hyperactive and oppositional-defiant symptoms']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0424101', 'cui_str': 'Inattention'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0040162', 'cui_str': 'Thyrotropin-Releasing Hormone'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037431', 'cui_str': 'Social problem'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424101', 'cui_str': 'Inattention'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0860661', 'cui_str': 'Oppositional'}]",,0.0580394,"The intervention resulted in significant reduction of inattentive-impulsive-hyperactive and oppositional-defiant symptoms in Conners-IOWA-10 and significant reduction of symptoms in the following CBCL scales: ""Social problems"", ""Attention problems"", ""Aggressive behavior"", ""Externalizing behavior"", as well as the overall score, as rated by mothers.","[{'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Pisula', 'Affiliation': 'Warszawski Uniwersytet Medyczny, Klinika Psychiatrii Wieku Rozwojowego.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Bryńska', 'Affiliation': 'Warszawski Uniwersytet Medyczny, Klinika Psychiatrii Wieku Rozwojowego.'}, {'ForeName': 'Stanisław', 'Initials': 'S', 'LastName': 'Wójtowicz', 'Affiliation': 'Warszawski Uniwersytet Medyczny, Zakład Psychologii i Komunikacji Medycznej.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Srebnicki', 'Affiliation': 'Warszawski Uniwersytet Medyczny, Klinika Psychiatrii Wieku Rozwojowego.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Wolańczyk', 'Affiliation': 'Warszawski Uniwersytet Medyczny, Klinika Psychiatrii Wieku Rozwojowego.'}]",Psychiatria polska,['10.12740/PP/103618']
1987,32772073,The influence of oxygen concentration during embryo culture on obstetric and neonatal outcomes: a secondary analysis of a randomized controlled trial.,"STUDY QUESTION


Does oxygen concentration during 3-day embryo culture affect obstetric and neonatal outcomes?
SUMMARY ANSWER


Oxygen concentration during 3-day embryo culture does not seem to affect the obstetric and neonatal outcomes measured.
WHAT IS KNOWN ALREADY


Atmospheric oxygen appears to be harmful during extended embryo culture. Embryo culture conditions might therefore be a potential risk factor for subsequent fetal development and the health of future children. No data are available concerning the obstetrics and neonatal outcomes after Day 3 transfer of embryos cultured under reduced and atmospheric oxygen tensions.
STUDY DESIGN, SIZE, DURATION


A secondary analysis of a previous randomized controlled trial assessing clinical pregnancy outcomes was carried out. This analysis included 1125 consecutive oocyte donation cycles utilizing ICSI or IVF and Day 3 embryo transfers between November 2009 and April 2012. The whole cohort of donated oocytes from patients who agreed to participate in the study were randomly allocated (1:1 ratio) to a reduced O2 tension group (6% O2) or an air-exposed group (20% O2) based on a computer-generated randomization list. Fresh and vitrified oocytes were used for oocyte donation. Only those pregnancies with a live birth at or beyond 24 weeks of gestation were included.
PARTICIPANTS/MATERIALS, SETTING, METHODS


Day 3 embryos were cultured in an atmosphere of 5.5% CO2, 6% O2, 88.5% N2 versus a dual gas system in air.
MAIN RESULTS AND THE ROLE OF CHANCE


From the eligible 1125 cycles, 564 were allocated to the 6% O2 group and 561 cycles to the 20% O2 group. However, 50 and 62 cycles did not reach embryo transfer in the 6% and 20% O2 groups, respectively. No differences were found between 6% O2 and atmospheric O2 tension in the number of livebirths per embryo transfer (mean ± SD, 0.5 ± 0.7 versus 0.5 ± 0.7), pregnancy complications or neonatal outcomes. Both groups (6% and atmospheric O2) had similar single and twin delivery rates (40.8% versus 38.1% and 10.7% versus 12.3%, respectively). Preterm delivery rates and very preterm delivery rates (10.80% versus 13.24% and 1.25% versus 2.94%, respectively), birthweight (3229 ± 561 g versus 3154 ± 731 g), low birthweight (2.92% versus 2.45%), birth height (50.18 ± 2.41 cm versus 49.7 ± 3.59 cm), head circumference (34.16 ± 1.87 cm versus 33.09 ± 1.85 cm) and 1 min Apgar scores (8.96 ± 0.87 versus 8.89 ± 0.96) were also similar between 6% and atmospheric O2 groups, respectively.
LIMITATIONS, REASONS FOR CAUTION


The number of liveborns finally analyzed is still small and not all obstetric and neonatal variables could be evaluated. Furthermore, a small proportion of the obstetric and neonatal data was obtained through a questionnaire filled out by the patients themselves. One reason for the lack of effect of oxygen concentration on pregnancy outcome could be the absence of trophectoderm cells at cleavage stage, which may make Day 3 embryos less susceptible to hypoxic conditions.
WIDER IMPLICATIONS OF THE FINDINGS


Nowadays many IVF laboratories use a more physiological oxygen concentration for embryo culture. However, the benefits of using low oxygen concentration on both laboratory and clinical outcomes during embryo culture are still under debate. Furthermore, long-term studies investigating the effect of using atmospheric O2 are also needed. Gathering these type of clinical data is indeed, quite relevant from the safety perspective. The present data show that, at least in egg donation cycles undergoing Day 3 embryo transfers, culturing embryos under atmospheric oxygen concentration seems not to affect perinatal outcomes.
STUDY FUNDING/COMPETING INTEREST(S)


The present project was supported by the R + D program of the Regional Valencian Government, Spain (IMPIVA IMDTF/2011/214). The authors declare that they have no conflict of interest with respect to the content of this manuscript.
TRIAL REGISTRATION NUMBER


NCT01532193.",2020,"No differences were found between 6% O2 and atmospheric O2 tension in the number of livebirths per embryo transfer (mean ± SD, 0.5 ± 0.7 versus 0.5 ± 0.7), pregnancy complications or neonatal outcomes.",['1125 consecutive oocyte donation cycles utilizing ICSI or IVF and Day 3 embryo transfers between November 2009 and April 2012'],['reduced O2 tension group (6% O2) or an air-exposed group (20% O2) based on a computer-generated randomization list'],"['oxygen concentration', 'birth height', 'pregnancy complications or neonatal outcomes', 'reach embryo transfer', 'low birthweight', 'O2 and atmospheric O2 tension', 'head circumference', 'min Apgar scores', 'similar single and twin delivery rates', 'Preterm delivery rates and very preterm delivery rates']","[{'cui': 'C0242813', 'cui_str': 'Oocyte donation'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0428646', 'cui_str': 'Oxygen concentration'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0032962', 'cui_str': 'Complication of pregnancy'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0233365', 'cui_str': 'Twin birth'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}]",1125.0,0.140438,"No differences were found between 6% O2 and atmospheric O2 tension in the number of livebirths per embryo transfer (mean ± SD, 0.5 ± 0.7 versus 0.5 ± 0.7), pregnancy complications or neonatal outcomes.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rendón Abad', 'Affiliation': 'OBGYN Department, School of Medicine, Valencia University, Valencia, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Serra', 'Affiliation': 'OBGYN Department, School of Medicine, Valencia University, Valencia, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Gámiz', 'Affiliation': 'In Vitro Fertilization Laboratory, IVIRMA Valencia, Valencia, Spain.'}, {'ForeName': 'José Maria', 'Initials': 'JM', 'LastName': 'de Los Santos', 'Affiliation': 'OBGYN Department, School of Medicine, Valencia University, Valencia, Spain.'}, {'ForeName': 'Josè', 'Initials': 'J', 'LastName': 'Remohí', 'Affiliation': 'OBGYN Department, School of Medicine, Valencia University, Valencia, Spain.'}, {'ForeName': 'Alfredo T', 'Initials': 'AT', 'LastName': 'Navarro', 'Affiliation': 'IVI Foundation, Instituto de Investigación Sanitaria la Fe, Valencia, Spain.'}, {'ForeName': 'Maria José', 'Initials': 'MJ', 'LastName': 'de Los Santos', 'Affiliation': 'OBGYN Department, School of Medicine, Valencia University, Valencia, Spain.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa152']
1988,32778902,Effects of electromechanically assisted gait trainer with Exowalk® in patients with chronic stroke: A randomized controlled trial.,"OBJECTIVE


To assess the effect on walking ability of electromechanically assisted gait training with a gait trainer (Exowalk®) for patients with chronic stroke.
DESIGN


Randomized controlled trial.
SUBJECTS


Forty patients with hemiplegia after stroke.
METHODS


Patients were randomly assigned to control and experimental groups. The control group underwent physical therapist-assisted gait training and the experimental group underwent electromechanically assisted gait training. Interventions were provided for 60 min, 5 days a week, for a period of 2 weeks. Primary outcome was change in Functional Ambulatory Category. Secondary outcomes were walking speed, walking capacity, leg muscle strength and balance. All outcomes were measured before and after the intervention.
RESULTS


Although the Functional Ambulatory Category improved significantly after gait training in both groups, the change in Functional Ambulatory Category did not differ between groups. In both groups most secondary outcomes also improved after gait training, but the changes in secondary outcomes did not differ between groups.
CONCLUSION


In patients with chronic stroke, walking improved after gait training with or without electromechanical assistance. Electromechanically assisted gait training was not superior to conventional physiotherapy.",2020,"In both groups most secondary outcomes also improved after gait training, but the changes in secondary outcomes did not differ between groups.
","['Forty patients with hemiplegia after stroke', 'Patients', 'patients with chronic stroke']","['Electromechanically assisted gait training', 'electromechanically assisted gait trainer with Exowalk®', 'physical therapist-assisted gait training and the experimental group underwent electromechanically assisted gait training', 'gait training with or without electromechanical assistance', 'electromechanically assisted gait training with a gait trainer (Exowalk®']","['gait training', 'change in Functional Ambulatory Category', 'Functional Ambulatory Category', 'walking speed, walking capacity, leg muscle strength and balance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0224456', 'cui_str': 'Skeletal muscle structure of lower leg'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",40.0,0.138863,"In both groups most secondary outcomes also improved after gait training, but the changes in secondary outcomes did not differ between groups.
","[{'ForeName': 'Yeon-Gyo', 'Initials': 'YG', 'LastName': 'Nam', 'Affiliation': 'Rehabilitation Medicine, Graduate School of Dongguk University, Korea.'}, {'ForeName': 'Jin Woo', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Ho Jun', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Ki Yeun', 'Initials': 'KY', 'LastName': 'Nam', 'Affiliation': ''}, {'ForeName': 'Myong Ryol', 'Initials': 'MR', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'Chang Seon', 'Initials': 'CS', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Liguo', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Jin Won', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Bum Sun', 'Initials': 'BS', 'LastName': 'Kwon', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2723']
1989,32778907,Active heel-slide exercise therapy facilitates the functional and proprioceptive enhancement following total knee arthroplasty compared to continuous passive motion.,"PURPOSE


The aim was to compare active heel-slide exercise (AHSE) + standard physiotherapy (PT) to continuous passive motion (CPM) + standard PT during inpatient rehabilitation of total knee arthroplasty (TKA) patients in terms of postoperative outcomes.
METHODS


Patients were randomly assigned into AHSE or CPM groups. Both groups received standard PT (range of motion and strengthening exercises, and ambulation) during hospital stay. Patients were evaluated regarding functional outcomes, knee proprioception, pain intensity, active range of motion, knee circumference, length of hospital stay, time for achieving straight leg raise actively, time for achieving 70° knee flexion.
RESULTS


Groups were similar at baseline (n.s.). At discharge, AHSE group was better in terms of pain intensity (p < 0.001), Hospital for Special Surgery knee score (p = 0.001), rise from sitting (p = 0.015), ascend/descend stairs (p = 0.038), and timed up and go test (p = 0.028) compared to CPM group. AHSE group was able to perform the straight leg raise earlier than CPM group during inpatient period (p = 0.001) and demonstrated improved proprioception at discharge and at 3-month follow-up (p < 0.05). No statistical differences were detected between groups in other evaluation parameters (n.s.).
CONCLUSION


Our findings support AHSE therapy offers a more functional rehabilitation and leads beneficial results for patients following TKA. Therefore, active exercise approach encouraging patients to participate in their rehabilitation should be first choice in acute postoperative rehabilitation following TKA rather than CPM.
LEVEL OF EVIDENCE


II.",2020,"At discharge, AHSE group was better in terms of pain intensity (p < 0.001), Hospital for Special Surgery knee score (p = 0.001), rise from sitting (p = 0.015), ascend/descend stairs (p = 0.038), and timed up and go test (p = 0.028) compared to CPM group.","['patients following TKA', 'total knee arthroplasty (TKA) patients', 'Patients']","['active heel-slide exercise (AHSE)\u2009+\u2009standard physiotherapy (PT) to continuous passive motion (CPM)\u2009+\u2009standard PT', 'AHSE', 'standard PT (range of motion and strengthening exercises, and ambulation', 'Active heel-slide exercise therapy', 'AHSE or CPM']","['proprioception at discharge', 'straight leg raise earlier', 'functional outcomes, knee proprioception, pain intensity, active range of motion, knee circumference, length of hospital stay, time for achieving straight leg raise actively, time for achieving 70° knee flexion', 'pain intensity', 'Hospital for Special Surgery knee score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0332246', 'cui_str': 'Sliding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0422926', 'cui_str': 'Straight leg raise test response'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0187769', 'cui_str': 'Operative procedure on knee'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0300555,"At discharge, AHSE group was better in terms of pain intensity (p < 0.001), Hospital for Special Surgery knee score (p = 0.001), rise from sitting (p = 0.015), ascend/descend stairs (p = 0.038), and timed up and go test (p = 0.028) compared to CPM group.","[{'ForeName': 'Musa', 'Initials': 'M', 'LastName': 'Eymir', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Dokuz Eylul University, Balcova, TR-35340, Izmir, Turkey. fztmusaeymir@hotmail.com.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Erduran', 'Affiliation': 'Department of Orthopaedics and Traumatology, Faculty of Medicine, Dokuz Eylul University, Balcova, TR-35340, Izmir, Turkey.'}, {'ForeName': 'Bayram', 'Initials': 'B', 'LastName': 'Ünver', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Dokuz Eylul University, Balcova, TR-35340, Izmir, Turkey.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-06181-4']
1990,32778913,"Acute mechanical, physiological and perceptual responses in older men to traditional-set or different cluster-set configuration resistance training protocols.","PURPOSE


The aims of this study were to compare mechanical outputs (i.e. power and impulse), physiological (i.e. heart rate) and perceptual (i.e. effort and fatigue) responses in older men to traditional-set or different cluster-set configuration resistance training protocols.
METHODS


In a randomized cross-over design, 20 healthy old men (aged 67.2 ± 2.1 years) completed four resistance training sessions using the back squat exercise loaded with optimal power loads. Training configurations were: traditional (TRA), three sets of six repetitions with 120-s rest between each set; Cluster-set 1 (CLU1), 24 single-repetition clusters with 10 s of rest after every cluster; Cluster-set 2 (CLU2), 12 double-repetition clusters with 20-s rest after every cluster; and Cluster-set 4 (CLU4), 6 quadruple-repetition clusters with 40-s rest after every cluster.
RESULTS


Cluster-set configurations resulted in greater power outputs compared to traditional-set configuration (range 2.6-9.2%, all p [Formula: see text] 0.07 for main effect and protocol [Formula: see text] set interactions). CLU1 and CLU2 induced higher heart rate (range 7.1-10.5%, all p < 0.001 for main effect and protocol [Formula: see text] set interactions), lower rating of perceived exertion (range - 1.3 to - 3.2 AU, all p [Formula: see text] 0.006 for pairwise comparisons) and lower ratings of fatigue (range - 0.15 to - 4 AU, all p [Formula: see text] 0.012 for pairwise comparisons) compared to TRA and CLU4. Finally, an absolute preference for CLU2 was reported.
CONCLUSIONS


Findings presented here support the prescription of CLU2 as an optimal resistance training configuration for trained older men using the back squat.",2020,"CLU1 and CLU2 induced higher heart rate (range 7.1-10.5%, all p < 0.001 for main effect and protocol [Formula: see text] set interactions), lower rating of perceived exertion (range - 1.3 to - 3.2 AU,","['trained older men using the back squat', '20 healthy old men (aged 67.2\u2009±\u20092.1\xa0years', 'older men to traditional-set or different cluster-set configuration resistance training protocols', 'older men']","['CLU1 and CLU2', 'resistance training sessions using the back squat exercise loaded with optimal power loads']","['heart rate', 'lower ratings of fatigue', 'mechanical outputs (i.e. power and impulse), physiological (i.e. heart rate) and perceptual (i.e. effort and fatigue) responses', 'Acute mechanical, physiological and perceptual responses']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",,0.043265,"CLU1 and CLU2 induced higher heart rate (range 7.1-10.5%, all p < 0.001 for main effect and protocol [Formula: see text] set interactions), lower rating of perceived exertion (range - 1.3 to - 3.2 AU,","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Dello Iacono', 'Affiliation': 'University of the West of Scotland (School of Health and Life Sciences), Hamilton, UK. antonio.delloiacono@uws.ac.uk.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Martone', 'Affiliation': ""Universita' Degli Studi di Napoli (Dipartimento di Science Motorie e Benessere), Naples, Italy.""}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Hayes', 'Affiliation': 'University of the West of Scotland (School of Health and Life Sciences), Hamilton, UK.'}]",European journal of applied physiology,['10.1007/s00421-020-04453-y']
1991,32778992,Integrating Tobacco Prevention Skills into an Evidence-Based Intervention for Adolescents with ADHD: Results from a Pilot Efficacy Randomized Controlled Trial.,"Adolescents with attention-deficit/hyperactivity disorder (ADHD) are at high risk for tobacco use, but tobacco use prevention strategies are not regularly incorporated into evidence-based ADHD interventions. We conducted a pilot randomized-controlled trial to determine the feasibility of integrating tobacco use prevention skills into a behavioral treatment for ADHD and to provide preliminary efficacy data comparing a combined (ADHD + tobacco) intervention (N = 40) to an ADHD only intervention (N = 23) on tobacco risk outcomes. Sixty-three adolescents (72% male; 13-17 years) with ADHD and their caregivers were randomly assigned to condition and families were masked to condition. Parent and adolescent ratings were collected at baseline, immediate post-intervention, and at 3- and 9-month follow-up assessments. The combined intervention was (1) implemented with high fidelity (94%), (2) well received by parents and adolescents as evidenced by high levels of treatment attendance (82%) and satisfaction with the intervention, and (3) associated with parent- and adolescent-reported reductions in tobacco use risk. Relative to the ADHD intervention, the combined intervention buffered against increases in tobacco risk, including reduced intentions to smoke and maladaptive social normative beliefs, and increased parental control, family cohesion, and family communication about substance use. Effect sizes at post-treatment were in the small to moderate range. Overall, this study provides preliminary support for a parent-adolescent behavioral treatment supplemented with family-based tobacco prevention strategies. This approach targets families already in treatment for ADHD, reducing barriers that occur when families attend multi-session prevention programs in addition to ADHD treatment.",2020,"The combined intervention was (1) implemented with high fidelity (94%), (2) well received by parents and adolescents as evidenced by high levels of treatment attendance (82%) and satisfaction with the intervention, and (3) associated with parent- and adolescent-reported reductions in tobacco use risk.","['Adolescents with ADHD', 'Adolescents with attention-deficit/hyperactivity disorder (ADHD', 'Sixty-three adolescents (72% male; 13-17\xa0years) with ADHD and their caregivers']",['combined (ADHD + tobacco) intervention'],"['tobacco risk, including reduced intentions to smoke and maladaptive social normative beliefs, and increased parental control, family cohesion, and family communication about substance use', 'Parent and adolescent ratings']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",,0.0726723,"The combined intervention was (1) implemented with high fidelity (94%), (2) well received by parents and adolescents as evidenced by high levels of treatment attendance (82%) and satisfaction with the intervention, and (3) associated with parent- and adolescent-reported reductions in tobacco use risk.","[{'ForeName': 'Rosalie', 'Initials': 'R', 'LastName': 'Corona', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA. racorona@vcu.edu.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Dvorsky', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Romo', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Parks', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}, {'ForeName': 'Elizaveta', 'Initials': 'E', 'LastName': 'Bourchtein', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}, {'ForeName': 'Zoe R', 'Initials': 'ZR', 'LastName': 'Smith', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Avila', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Langberg', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}]",Journal of abnormal child psychology,['10.1007/s10802-020-00689-6']
1992,32779034,Docetaxel plus S-1 versus cisplatin plus S-1 in unresectable gastric cancer without measurable lesions: a randomized phase II trial (HERBIS-3).,"BACKGROUND


Cisplatin plus S-1 (CS) is the standard first-line chemotherapy for advanced gastric cancer (AGC) in Japan. A previous phase III trial showed that docetaxel plus S-1 (DS) was effective for AGC without measurable lesions, but no studies have compared these two regimens.
METHODS


Eligible patients had unresectable or recurrent HER2-negative AGC without measurable lesions. Patients were randomized to DS (docetaxel 40 mg/m 2  on day 1, S-1 80-120 mg on days 1-14, every 3 weeks) or CS (cisplatin 60 mg/m 2  on day 8, S-1 80-120 mg on days 1-21, every 5 weeks). The primary endpoint was overall survival (OS).
RESULTS


All patients had unresectable primary disease. Sixty-one patients were randomly assigned to DS (n = 30) or CS (n = 31). One CS patient was ineligible due to HER2 positivity. The median number of cycles was 9.5 (range 2-49) with DS and 5.5 (range 1-10) with CS. There were no treatment-related deaths. The most common grade 3-4 non-hematological toxicity was fatigue (7% with DS, 13% with CS), followed by anorexia (3% with DS, 10% with CS) and diarrhea (3% with DS, 10% with CS). The 2-year OS rates were 43.3% with DS and 30.0% with CS (log-rank P = 0.113), with a hazard ratio of 0.617 (95% confidence interval 0.337-1.128), indicating non-inferiority of DS to CS with respect to OS (P < 0.001).
CONCLUSIONS


DS showed slightly but nonsignificantly less toxicity and higher efficacy than CS for AGC without measurable lesions. DS should be further investigated in phase III trials.",2020,There were no treatment-related deaths.,"['advanced gastric cancer (AGC) in Japan', 'All patients had unresectable primary disease', 'Sixty-one patients', 'Eligible patients had unresectable or recurrent HER2-negative AGC without measurable lesions', 'unresectable gastric cancer without measurable lesions']","['Docetaxel plus S-1 versus cisplatin plus S-1', 'DS', 'CS (cisplatin 60\xa0mg', 'docetaxel plus S-1', 'CS', 'Cisplatin plus S-1 (CS', 'DS (docetaxel 40\xa0mg/m 2  on day 1']","['diarrhea', 'median number of cycles', 'anorexia', 'toxicity', 'hematological toxicity', '2-year OS rates', 'overall survival (OS']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",61.0,0.10004,There were no treatment-related deaths.,"[{'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Kurokawa', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2-E2, Yamadaoka, Suita, Osaka, 565-0871, Japan. ykurokawa@gesurg.med.osaka-u.ac.jp.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Matsuyama', 'Affiliation': 'Department of Surgery, Yao Municipal Hospital, Osaka, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Takeno', 'Affiliation': 'Department of Surgery, Kansai Rosai Hospital, Hyogo, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Kimura', 'Affiliation': 'Department of Surgery, Sakai City Medical Center, Osaka, Japan.'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Fujitani', 'Affiliation': 'Department of Surgery, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Ryohei', 'Initials': 'R', 'LastName': 'Kawabata', 'Affiliation': 'Department of Surgery, Osaka Rosai Hospital, Osaka, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Makari', 'Affiliation': 'Department of Surgery, Minoh City Hospital, Osaka, Japan.'}, {'ForeName': 'Tetsuji', 'Initials': 'T', 'LastName': 'Terazawa', 'Affiliation': 'Cancer Chemotherapy Center, Osaka Medical College, Osaka, Japan.'}, {'ForeName': 'Hisato', 'Initials': 'H', 'LastName': 'Kawakami', 'Affiliation': 'Department of Medical Oncology, Faculty of Medicine, Kindai University, Osaka, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sakai', 'Affiliation': 'Department of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Shimokawa', 'Affiliation': 'Clinical Study Support Center, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Taroh', 'Initials': 'T', 'LastName': 'Satoh', 'Affiliation': 'Department of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Osaka, Japan.'}]",Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association,['10.1007/s10120-020-01112-1']
1993,32779057,"Correction of serum potassium with sodium zirconium cyclosilicate in Japanese patients with hyperkalemia: a randomized, dose-response, phase 2/3 study.","BACKGROUND


Sodium zirconium cyclosilicate (SZC) is an oral potassium binder approved to treat hyperkalemia in adults in a number of countries, including Japan.
METHODS


This phase 2/3, randomized, double-blind, placebo-controlled, dose-response study (ClinicalTrials.gov: NCT03127644) was designed to determine the efficacy and safety of SZC in Japanese adults with hyperkalemia. Patients with serum potassium (sK + ) concentrations ≥ 5.1- ≤ 6.5 mmol/L were randomized 1:1:1 to SZC 5 g, SZC 10 g, or placebo three times daily for 48 h (six doses total). The primary efficacy endpoint was the exponential rate of change in sK +  over 48 h. The proportion of patients with normokalemia (sK +  3.5-5.0 mmol/L) at 48 h and adverse events (AEs) were also evaluated.
RESULTS


Overall, 103 patients (mean age, 73.2 years; range 50-89 years) received SZC 5 g (n = 34), SZC 10 g (n = 36), or placebo (n = 33). The exponential rate of sK +  change from 0 to 48 h versus placebo was - 0.00261 (SZC 5 g) and - 0.00496 (SZC 10 g; both P < 0.0001). At 48 h, the proportions of patients with normokalemia were 85.3%, 91.7%, and 15.2% with SZC 5 g, SZC 10 g, and placebo, respectively. No serious AEs were reported. Hypokalemia (sK +   < 3.5 mmol/L) occurred in two patients in the SZC 10 g group; normokalemia was re-established within 6 days and no treatment-related AEs were reported.
CONCLUSION


SZC is effective and well tolerated in Japanese patients with hyperkalemia.",2020,The exponential rate of sK +  change from 0 to 48 h versus placebo was - 0.00261,"['adults in a number of countries, including Japan', 'Japanese adults with hyperkalemia', 'Patients with serum potassium (sK + ) concentrations\u2009≥\u20095.1', 'Japanese patients with hyperkalemia', '103 patients (mean age, 73.2\xa0years; range 50-89\xa0years']","['serum potassium with sodium zirconium cyclosilicate', 'SZC', 'Sodium zirconium cyclosilicate (SZC', 'SZC 5', 'placebo']","['efficacy and safety', 'exponential rate of sK +  change', 'Hypokalemia', 'exponential rate of change in sK +  over 48\xa0h']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C4045824', 'cui_str': 'sodium zirconium cyclosilicate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",103.0,0.427485,The exponential rate of sK +  change from 0 to 48 h versus placebo was - 0.00261,"[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Kashihara', 'Affiliation': 'Department of Nephrology and Hypertension, Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Nishio', 'Affiliation': 'Nephrology Dialysis Center, Kusatsu General Hospital, Shiga, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Osonoi', 'Affiliation': 'Department of Internal Medicine, Nakakinen Clinic, Ibaraki, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Saka', 'Affiliation': 'Department of Nephrology, Kasugai Municipal Hospital, Aichi, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Imasawa', 'Affiliation': 'Department of Nephrology, Chiba-Higashi Hospital, Chiba, Japan.'}, {'ForeName': 'Takayasu', 'Initials': 'T', 'LastName': 'Ohtake', 'Affiliation': 'Department of Nephrology, Shonan Kamakura General Hospital, Kanagawa, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Mizuno', 'Affiliation': 'Department of Nephrology, Inage Hospital, Chiba, Japan.'}, {'ForeName': 'Yugo', 'Initials': 'Y', 'LastName': 'Shibagaki', 'Affiliation': 'Division of Nephrology and Hypertension, St. Marianna University School of Medicine Hospital, Kanagawa, Japan.'}, {'ForeName': 'Hyosung', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Research and Development, AstraZeneca K.K, 1-8-3, Marunouchi, Chiyoda-ku, Tokyo, 100-0005, Japan.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Yajima', 'Affiliation': 'Research and Development, AstraZeneca K.K, 1-8-3, Marunouchi, Chiyoda-ku, Tokyo, 100-0005, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Sarai', 'Affiliation': 'Research and Development, AstraZeneca K.K, 1-8-3, Marunouchi, Chiyoda-ku, Tokyo, 100-0005, Japan. nobuaki.sarai@astrazeneca.com.'}]",Clinical and experimental nephrology,['10.1007/s10157-020-01937-1']
1994,32779096,"IncobotulinumtoxinA for the Treatment of Blepharospasm in Toxin-Naïve Subjects: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial.","This study aimed to assess the efficacy/safety of incobotulinumtoxinA (Xeomin ® , Merz Pharmaceuticals GmbH) in botulinum neurotoxin-naïve subjects with blepharospasm. Botulinum neurotoxin-naïve subjects (≥ 12 months without botulinum neurotoxin treatment for blepharospasm) received single-dose incobotulinumtoxinA 50 U, 25 U, or placebo. Subjects were followed for 6-20 weeks (main period). Qualified subjects entered an open-label extension period and received another incobotulinumtoxinA injection (≤ 70 U). The primary efficacy variable was change from baseline in the Jankovic Rating Scale (JRS) severity subscore at the main period of week 6. Other efficacy variables included changes in the Blepharospasm Disability Index score and JRS frequency subscore and sumscore. Adverse events were monitored. Sixty-one subjects were randomized (main period: incobotulinumtoxinA 50 U, n = 19; incobotulinumtoxinA 25 U, n = 22; placebo, n = 20); 39 entered the open-label extension period (9, 14, and 16 subjects from the incobotulinumtoxinA 50 U, incobotulinumtoxinA 25 U, and placebo groups [main period], respectively, changed to open-label extension period dosing). A statistically significantly greater reduction in JRS severity subscore was reported for subjects receiving incobotulinumtoxinA 50 U versus placebo (ANCOVA, least square mean difference: - 1.2, p = 0.0004). Subjects receiving incobotulinumtoxinA experienced improvements in other efficacy variables versus baseline and/or placebo. Sustained clinical improvements and low adverse event rates (22.2-42.1%) were observed. This is the second placebo-controlled, double-blind study that demonstrates favorable efficacy/safety of incobotulinumtoxinA in subjects with blepharospasm. IncobotulinumtoxinA is the first botulinum neurotoxin that could fulfill the American Academy of Neurology criteria for a Level A recommendation for blepharospasm.Trial registration ClinicalTrials.gov identifier, NCT01896895.",2020,"A statistically significantly greater reduction in JRS severity subscore was reported for subjects receiving incobotulinumtoxinA 50 U versus placebo (ANCOVA, least square mean difference: - 1.2, p = 0.0004).","['botulinum neurotoxin-naïve subjects with blepharospasm', 'Sixty-one subjects were randomized (main period', 'subjects with blepharospasm']","['IncobotulinumtoxinA', 'Placebo', 'incobotulinumtoxinA 50 U, n\u2009=\u200919; incobotulinumtoxinA 25 U, n\u2009=\u200922; placebo, n\u2009=\u200920', 'Botulinum neurotoxin-naïve subjects (≥\u200912\xa0months without botulinum neurotoxin', 'incobotulinumtoxinA', 'incobotulinumtoxinA injection', 'single-dose incobotulinumtoxinA 50 U, 25\xa0U, or placebo', 'incobotulinumtoxinA 50 U, incobotulinumtoxinA 25 U, and placebo', 'placebo']","['low adverse event rates', 'Adverse events', 'Blepharospasm Disability Index score and JRS frequency subscore and sumscore', 'Jankovic Rating Scale (JRS) severity subscore', 'JRS severity subscore']","[{'cui': 'C1295507', 'cui_str': 'Bontoxilysin'}, {'cui': 'C0005747', 'cui_str': 'Blepharospasm'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C2930113', 'cui_str': 'IncobotulinumtoxinA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1295507', 'cui_str': 'Bontoxilysin'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005747', 'cui_str': 'Blepharospasm'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",61.0,0.42825,"A statistically significantly greater reduction in JRS severity subscore was reported for subjects receiving incobotulinumtoxinA 50 U versus placebo (ANCOVA, least square mean difference: - 1.2, p = 0.0004).","[{'ForeName': 'Dimos D', 'Initials': 'DD', 'LastName': 'Mitsikostas', 'Affiliation': '1st Department of Neurology, National and Kapodistrian University of Athens, Athens, Greece. dimosmitsikostas@icloud.com.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Dekundy', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Sternberg', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Althaus', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pagan', 'Affiliation': 'Department of Neurology, Georgetown University Hospital Pasquerilla Healthcare Center, Washington, DC, USA.'}]",Advances in therapy,['10.1007/s12325-020-01427-6']
1995,32779140,Impact of an Opt-In eConsult Program on Primary Care Demand for Specialty Visits: Stepped-Wedge Cluster Randomized Implementation Study.,"BACKGROUND


eConsult programs have been instituted to increase access to specialty expertise. Opt-in choice eConsult programs maintain primary care physician (PCP) autonomy to decide whether to utilize eConsults versus traditional specialty referrals, but little is known about how this intervention may impact PCP eConsult adoption and traditional referral demand.
OBJECTIVE


We assessed the feasibility of implementing an opt-in choice eConsult program and examined whether this intervention reduces demand for in-person visits for primary care patients requiring specialty expertise.
DESIGN


Stepped-wedge, cluster randomized trial conducted from July 2018 to June 2019.
PARTICIPANTS


Sixteen primary care practices in a large, urban academic health care system.
INTERVENTION


Our intervention was an opt-in choice eConsult available in addition to traditional specialty referral; our implementation strategy included in-person training, audit and feedback, and incentive payments.
MAIN MEASURES


Our implementation outcome measure was the eConsult rate: weekly proportion of eConsults per PCP visit at each site. Our intervention outcome measure was traditional referral rate: weekly proportion of referrals per PCP visit at each site. We also assessed PCP experiences with questionnaires.
KEY RESULTS


Of 305,915 in-person PCP visits, there were 31,510 traditional referrals to specialties participating in the eConsult program, and 679 eConsults. All but one primary care site utilized the opt-in choice eConsult program, with a weekly rate of 0.05 eConsults per 100 PCP visits by the end of the study period. The weekly rate of traditional referrals was 11 per 100 PCP visits at the end of the study period; this represents a significant increase in traditional referral rate after implementation of eConsults. PCPs were generally satisfied with the eConsult program and valued prompt provider-to-provider communication.
CONCLUSIONS


Implementation of an opt-in choice eConsult program resulted in widespread PCP adoption; however, this did not decrease the demand for traditional referrals. Future studies should evaluate different strategies to incentivize and increase eConsult utilization while maintaining PCP choice.",2020,The weekly rate of traditional referrals was 11 per 100 PCP visits at the end of the study period; this represents a significant increase in traditional referral rate after implementation of eConsults.,"['July 2018 to June 2019', 'Of 305,915 in-person PCP visits', '31,510 traditional referrals to specialties participating in the eConsult program, and 679 eConsults', 'Sixteen primary care practices in a large, urban academic health care system', 'primary care patients requiring specialty expertise']",['Opt-In eConsult Program'],"['eConsult rate: weekly proportion of eConsults per PCP visit', 'traditional referral rate', 'traditional referral rate: weekly proportion of referrals per PCP visit at each site']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",,0.028566,The weekly rate of traditional referrals was 11 per 100 PCP visits at the end of the study period; this represents a significant increase in traditional referral rate after implementation of eConsults.,"[{'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Rikin', 'Affiliation': 'Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY, USA. Srikin@montefiore.org.'}, {'ForeName': 'Chenshu', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lipsey', 'Affiliation': 'Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Deluca', 'Affiliation': 'Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Epstein', 'Affiliation': 'Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Berger', 'Affiliation': 'Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Tomer', 'Affiliation': 'Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Arnsten', 'Affiliation': 'Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-06101-9']
1996,32777193,Intravenous Methylprednisolone versus Intravenous Methylprednisolone Combined with Inhaled Budesonide in Acute Severe Pediatric Asthma.,"Introduction:  Corticosteroids are important part of acute severe asthma (ASA) management in pediatric intensive care units. Few studies look at the efficacy of inhaled corticosteroids (ICS) in critical care settings. We aimed to investigate the potential beneficial effects of ICS when added to intravenous corticosteroids in pediatric patients with ASA admitted to the pediatric intensive care unit (PICU) Methods:  This was a randomized controlled trial involving pediatric patients aged 1-21 years admitted to PICU with ASA. Patients were randomized into 2 groups using block randomization. Patients in Group A received intravenous methylprednisolone (2mg/kg/day) alone and patients in Group B received intravenous methylprednisolone (2mg/kg/day) plus budesonide nebulization (0.5mg every 12 hours). Main outcomes were duration of continuous albuterol treatment, PICU and hospital length of stay (LOS), and need and duration of respiratory support. Kruskal-Wallis and Chi-square tests were used for statistical analysis, in which a p-value <0.05 was considered statistically significant. Results:  Duration of continuous albuterol treatment was not different between the 2 groups median/(QR), 30/(18-51) vs. 25/(14-49). (p = 0.38) PICU and hospital LOS between the 2 groups was similar, median/(QR), 44/(30-64) vs. 46/(30-62), (p = 0.75) and 78/(65-95) vs.72/(58-92), (p = 0.19). Number of patients requiring respiratory support was 22(58%) in Group A and 25(64%) in Group B. (p = 0.19) Conclusions:  In critically ill children with ASA, intravenous methylprednisolone combined with inhaled budesonide did not shorten the duration of continuous albuterol inhalation treatment, the PICU and hospital LOS, and the need for respiratory support.",2020,"was not different between the 2 groups median/(QR), 30/(18-51) vs. 25/(14-49).","['critically ill children with ASA, intravenous', 'pediatric patients with ASA admitted to the pediatric intensive care unit (PICU) Methods', 'pediatric patients aged 1-21 years admitted to PICU with ASA', 'Acute Severe Pediatric Asthma']","['Intravenous Methylprednisolone', 'methylprednisolone combined with inhaled budesonide', 'ICS', 'budesonide nebulization', 'Corticosteroids', 'intravenous methylprednisolone', 'inhaled corticosteroids (ICS', 'Methylprednisolone Combined with Inhaled Budesonide', 'intravenous corticosteroids']","['duration of continuous albuterol treatment, PICU and hospital length of stay (LOS), and need and duration of respiratory support', 'hospital LOS', 'duration of continuous albuterol inhalation treatment, the PICU and hospital LOS', 'Kruskal-Wallis and Chi-square tests']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0008041', 'cui_str': 'Chi-Square Test'}]",,0.151915,"was not different between the 2 groups median/(QR), 30/(18-51) vs. 25/(14-49).","[{'ForeName': 'Prabha', 'Initials': 'P', 'LastName': 'Gummalla', 'Affiliation': 'Department of Pediatrics, SUNY Downstate Health Sciences University, Brooklyn, NY.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Weaver', 'Affiliation': 'Department of Pediatrics, SUNY Downstate Health Sciences University, Brooklyn, NY.'}, {'ForeName': 'Youssef', 'Initials': 'Y', 'LastName': 'Ahmed', 'Affiliation': 'Department of Pediatrics, SUNY Downstate Health Sciences University, Brooklyn, NY.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Shah', 'Affiliation': 'Department of Pediatrics, Kings County Hospital Center, Brooklyn, NY.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Keenaghan', 'Affiliation': 'Department of Pediatrics, Kings County Hospital Center, Brooklyn, NY.'}, {'ForeName': 'Sule', 'Initials': 'S', 'LastName': 'Doymaz', 'Affiliation': 'Department of Pediatrics, SUNY Downstate Health Sciences University, Brooklyn, NY.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2020.1808988']
1997,32777247,Does Repositioning of Temporomandibular Joint Disc With Bone Anchors Provide Better Clinical Outcomes Than Conventional Disc Plication Procedures for Anterior Disc Displacements Without Reduction in Patients Refractory to Nonsurgical Treatments?,"PURPOSE


Although open temporomandibular joint arthroplasty with discopexy is a common treatment for patients with anterior disc displacements without reduction (ADDWo) unresponsive to medical management, there are no studies comparing disc repositioning with bone anchors and conventional discopexy procedure. The purpose of the study was to compare the efficacy between disc repositioning with bone anchors and the conventional discopexy procedure for ADDWo of temporomandibular joint refractory to medical management.
PATIENTS AND METHODS


A randomized controlled trial was conducted in patients with ADDWo. The primary objective was to compare the improvement in mouth opening (primary outcome variable) between the 2 treatment (primary predictor variable) groups-disc repositioning with bone anchors versus conventional disc plication. Secondary outcome variables were pain measured by visual analog scale, lateral excursions, and position of the disc evaluated by magnetic resonance imaging (MRI). Other variables of interest were age, gender, and duration of symptoms. The parameters were evaluated at preoperative period, postoperative day 1, and 1-, 6-, and 12-month postoperative period. Categorical variables were compared with χ 2  test and continuous variables with analysis of variance and adjusted for multiple comparisons with Bonferroni test.
RESULTS


The study sample comprised 14 patients (7 in each group) with MRI-proven ADDWo. Statistically significant differences were found in the improvement of mouth opening between the 2 groups, showing better improvement with bone anchors (14.42 ± 5.96 vs 7.57 ± 7.25 mm; P < .05). The reduction in visual analog scale also showed statistically significant difference with better pain reduction achieved with bone anchor (4.57 ± 1.61 vs 3.28 ± 0.75; P < .05). There was no statistically significant difference in lateral excursions and postoperative position of the disc evaluated by MRI between the groups at 12-month follow-up period.
CONCLUSIONS


Disc repositioning with bone anchors provides better clinical outcomes in terms of maximal mouth opening and pain scores compared with conventional disc plication.",2020,"Statistically significant differences were found in the improvement of mouth opening between the 2 groups, showing better improvement with bone anchors (14.42 ± 5.96 vs 7.57 ± 7.25 mm; P < .05).","['14 patients (7 in each group) with MRI-proven ADDWo', 'patients with anterior disc displacements without reduction (ADDWo) unresponsive to medical management', 'patients with ADDWo']","['discopexy', 'Conventional Disc Plication Procedures', 'disc repositioning with bone anchors and the conventional discopexy procedure', 'Disc repositioning with bone anchors']","['pain scores', 'Anterior Disc Displacements', 'improvement of mouth opening', 'pain reduction', 'Temporomandibular Joint Disc', 'pain measured by visual analog scale, lateral excursions, and position of the disc evaluated by magnetic resonance imaging (MRI', 'improvement in mouth opening', 'lateral excursions and postoperative position of the disc evaluated by MRI', 'visual analog scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C1720978', 'cui_str': 'Bone Anchors'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0376491', 'cui_str': 'Structure of articular disc of temporomandibular joint'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",14.0,0.0853924,"Statistically significant differences were found in the improvement of mouth opening between the 2 groups, showing better improvement with bone anchors (14.42 ± 5.96 vs 7.57 ± 7.25 mm; P < .05).","[{'ForeName': 'Jithin Sasikumar', 'Initials': 'JS', 'LastName': 'Puthukkudiyil', 'Affiliation': 'Senior Resident, Department of Oral and Maxillofacial Surgery, All India Institute of Medical Sciences, Ansari Nagar, New Delhi.'}, {'ForeName': 'Ongkila', 'Initials': 'O', 'LastName': 'Bhutia', 'Affiliation': 'Professor, Department of Oral and Maxillofacial Surgery, All India Institute of Medical Sciences, Ansari Nagar, New Delhi. Electronic address: dr_ongkila@rediffmail.com.'}, {'ForeName': 'Ajoy', 'Initials': 'A', 'LastName': 'Roychoudhury', 'Affiliation': 'Professor and Head, Department of Oral and Maxillofacial Surgery, All India Institute of Medical Sciences, Ansari Nagar, New Delhi.'}, {'ForeName': 'Krushna', 'Initials': 'K', 'LastName': 'Bhatt', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, All India Institute of Medical Sciences, Ansari Nagar, New Delhi.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Yadav', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, All India Institute of Medical Sciences, Ansari Nagar, New Delhi.'}, {'ForeName': 'Ashu Sieth', 'Initials': 'AS', 'LastName': 'Bhalla', 'Affiliation': 'Professor, Department of Oral and Maxillofacial Surgery, All India Institute of Medical Sciences, Ansari Nagar, New Delhi.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.07.013']
1998,32777289,"Fixed-dose combination of three drugs, i.e. LABA/LAMA/ICS for COPD: results of a real-world study from India.","BACKGROUND


The use of triple therapy with inhaled corticosteroids, long-acting beta-agonist and long-acting antimuscarinics has been shown to be beneficial in COPD patients who continue to have symptoms and exacerbations, despite receiving dual bronchodilator combinations. This study assessed the real-world effectiveness and safety of once-daily, fixed-dose combination of Tiotropium/Formoterol/Ciclesonide (TFC) (18 mcg/12 mcg/400 mcg) via dry powder inhaler (DPI) or metered dose inhaler (MDI) in patients with COPD.
PATIENTS AND METHODS


In this 24-week, open-label, prospective, non-comparative, multicentre, real-world study, COPD patients requiring triple therapy as judged by their physician, were enrolled. The primary endpoint was mean change from baseline in pre-dose Forced Expiratory Volume in one second (FEV 1 ) at week 24. Pre and post-dose (30 mins) FEV 1 , Forced Vital capacity (FVC), COPD Assessment Test (CAT), modified Medical Research Council (mMRC) score and safety were also evaluated. A post-hoc analysis was conducted to evaluate the efficacy of the triple drug combination among smoker and non-smoker COPD patients.
RESULTS


Out of the 297 patients enrolled [mean age 61±10 years; 84.8% males; 55.2% smokers and post-dose FEV 1  (% predicted) 39 + 16%, 253 completed the study. Mean change in pre-dose FEV 1  from baseline to week 24 increased significantly after administering the triple drug combination (580 ± 600 mL, 95% CI (510, 650 mL), p<0.0001). The increase in the pre-dose FEV 1  was significant at all time points (p< 0.0001). Similar improvements were seen in pre-dose FVC, post-dose FEV 1  and post-dose FVC across all time points. CAT scores and the proportion of patients with improved mMRC score improved at all visits. The post-hoc analysis showed that TFC significantly increased pre-dose FEV 1  both among smokers (mean change 200 ± 430 mL, (130, 270 mL), p<0.0001) as well as non-smokers (990 ± 470 mL, (530, 680 mL), p<0.0001) at week 24. This difference was significant from week 12 onwards. Mean change in pre and post-dose FEV 1  and FVC was significant across all visits between the two groups. At week 24, CAT score reduced significantly from baseline (overall: 6.6±6.09; smokers: 4.53±7.17; non-smokers: 8.06±4.44; all p<0.0001). The mean difference between the two groups was 2.88 (p<0.0001) at week 24. TFC was well tolerated.
CONCLUSION


In this real world, multicentre study in India, TFC significantly improved lung function, symptoms and quality of life among all patients with COPD, but the effect was more pronounced among non-smoker COPD patients.",2020,The increase in the pre-dose FEV 1  was significant at all time points (p< 0.0001).,"['COPD patients who continue to have symptoms and exacerbations, despite receiving dual bronchodilator combinations', 'patients with COPD', 'smoker and non-smoker COPD patients', 'COPD patients requiring triple therapy as judged by their physician, were enrolled', '297 patients enrolled [mean age 61±10 years; 84.8% males; 55.2% smokers and post-dose']","['LABA/LAMA/ICS', 'TFC', 'Tiotropium/Formoterol/Ciclesonide (TFC']","['CAT score', 'tolerated', 'mMRC score', 'FEV 1 , Forced Vital capacity (FVC), COPD Assessment Test (CAT), modified Medical Research Council (mMRC) score and safety', 'lung function, symptoms and quality of life', 'mean change from baseline in pre-dose Forced Expiratory Volume', 'CAT scores']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0221191', 'cui_str': 'Judge'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439568', 'cui_str': 'Post-dose'}]","[{'cui': 'C0999593', 'cui_str': 'Lama'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C0907850', 'cui_str': 'ciclesonide'}]","[{'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}]",297.0,0.141329,The increase in the pre-dose FEV 1  was significant at all time points (p< 0.0001).,"[{'ForeName': 'Sundeep', 'Initials': 'S', 'LastName': 'Salvi', 'Affiliation': 'Chest Research Foundation, Pune.'}, {'ForeName': 'Ashish Kumar', 'Initials': 'AK', 'LastName': 'Deb', 'Affiliation': 'Sudbhavana Hospital, Varanasi.'}, {'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Agarwal', 'Affiliation': 'Om Surgical Center & Maternity Home, Varanasi.'}, {'ForeName': 'Venkateswara Reddy', 'Initials': 'VR', 'LastName': 'Tummuru', 'Affiliation': 'Eesha Multispeciality Hospital, Hyderabad.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Kodgule', 'Affiliation': 'Chest Research Foundation, Pune.'}, {'ForeName': 'V S', 'Initials': 'VS', 'LastName': 'Hemalatha', 'Affiliation': 'Sree Narayana Institute of Medical Sciences, Ernakulam.'}, {'ForeName': 'Anil Kumar', 'Initials': 'AK', 'LastName': 'Awasthi', 'Affiliation': 'Ajantha Hospitals & IVF Centre Pvt. Ltd., Lucknow.'}, {'ForeName': 'K P', 'Initials': 'KP', 'LastName': 'Suraj', 'Affiliation': 'Institute of Chest Diseases, Kozhikode.'}, {'ForeName': 'Vinod Kumar', 'Initials': 'VK', 'LastName': 'Pavitran', 'Affiliation': 'KVM Multispeciality Hospital, Chirtihala.'}, {'ForeName': 'Shashi Prakash', 'Initials': 'SP', 'LastName': 'Mourya', 'Affiliation': 'Lal Hospital & Heart Centre, Lucknow.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Thomas', 'Affiliation': 'Madonna Hospital and Research Centre, Ernakulam.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Vaidya', 'Affiliation': 'Cipla Ltd, Mumbai.'}, {'ForeName': 'Sushmeeta', 'Initials': 'S', 'LastName': 'Chhowala', 'Affiliation': 'Cipla Ltd, Mumbai. Electronic address: sushmeeta@cipla.com.'}, {'ForeName': 'Jaideep', 'Initials': 'J', 'LastName': 'Gogtay', 'Affiliation': 'Cipla Ltd, Mumbai.'}]",Pulmonary pharmacology & therapeutics,['10.1016/j.pupt.2020.101932']
1999,32777381,Trial study design to test a bilingual digital health tool for alcohol use disorders among Latino emergency department patients.,"We describe an emergency department (ED)-based, Latino patient focused, unblinded, randomized controlled trial to empirically test if automated bilingual computerized alcohol screening and brief intervention (AB-CASI), a digital health tool, is superior to standard care (SC) on measures of alcohol consumption, alcohol-related negative behaviors and consequences, and 30-day treatment engagement. The trial design addresses the full spectrum of unhealthy drinking from high-risk drinking to severe alcohol use disorder (AUD). In an effort to surmount known ED-based alcohol screening, brief intervention, and referral to treatment process barriers, while addressing racial/ethnic alcohol-related health disparities among Latino groups, this trial will purposively use a digital health tool and seek enrollment of English and/or Spanish speaking self-identified adult Latino ED patients. Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish). The primary outcome will be the number of binge drinking days assessed using the 28-day timeline followback method at 12 months post-randomization. Secondary outcomes will include mean number of drinks/week and number of episodes of driving impaired, riding with an impaired driver, injuries, arrests, and tardiness and days absent from work/school. A sample size of 820 is necessary to provide 80% power to detect a 1.14 difference between AB-CASI and SC in the primary outcome. Showing efficacy of this promising bilingual ED-based brief intervention tool in Latino patients has the potential to widely and efficiently expand prevention efforts and facilitate meaningful contact with specialized treatment services.",2020,"Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish).","['Latino patients', 'English and/or Spanish speaking self-identified adult Latino ED patients', 'Latino emergency department patients', 'unhealthy drinking from high-risk drinking to severe alcohol use disorder (AUD']","['automated bilingual computerized alcohol screening and brief intervention (AB-CASI', 'bilingual digital health tool']","['mean number of drinks/week and number of episodes of driving impaired, riding with an impaired driver, injuries, arrests, and tardiness and days absent from work/school', 'number of binge drinking days assessed using the 28-day timeline followback method']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0073361', 'cui_str': 'RID'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",,0.0627793,"Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish).","[{'ForeName': 'Federico E', 'Initials': 'FE', 'LastName': 'Vaca', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: federico.vaca@yale.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dziura', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: james.dziura@yale.edu.'}, {'ForeName': 'Fuad', 'Initials': 'F', 'LastName': 'Abujarad', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: fuad.abujarad@yale.edu.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Pantalon', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: michael.pantalon@yale.edu.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Hsiao', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America; Yale School of Medicine, Department of Pediatrics, Section of Emergency Medicine, 100 York St, Suite 1F, New Haven, CT 06511, United States of America. Electronic address: allen.hsiao@yale.edu.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Field', 'Affiliation': 'University of Texas at El Paso, Latino Alcohol and Health Disparities Research Center (LAHDR), Psychology Building, Rooms 102 and 104, El Paso, TX 79968, United States of America. Electronic address: cfield@utep.edu.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': ""D'Onofrio"", 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: gail.donofrio@yale.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106104']
2000,32777383,"Rationale, design, and methods of the autism centers of excellence (ACE) network study of oxytocin in autism to improve reciprocal social behaviors (SOARS-B).","OBJECTIVE


To describe the rationale, design, and methods of the Autism Centers of Excellence (ACE) network Study of Oxytocin in Autism to improve Reciprocal Social Behaviors (SOARS-B).
METHOD


This phase 2 clinical trial was designed to evaluate the use of intranasal oxytocin treatment to improve social difficulties in individuals with autism spectrum disorder (ASD). In total, 290 participants ages 3 to 17 years with a DSM-5 diagnosis of ASD were enrolled to receive 24 weeks of treatment with either oxytocin or a matched placebo. Participants were subsequently treated with open-label oxytocin for 24 additional weeks. Post-treatment assessments were done 4 weeks after treatment discontinuation. Plasma oxytocin and oxytocin receptor gene (OXTR) methylation level were measured at baseline, week 8, 24 and 36 to explore potential relationships between these biomarkers and treatment response.
RESULTS


This report describes the rationale, design, and methods of the SOARS-B clinical trial.
CONCLUSIONS


There is a tremendous unmet need for effective pharmacological treatment options that target the core symptoms of ASD. Several studies support the hypothesis that intranasal oxytocin could improve social orienting and the salience of social rewards in ASD, thereby enhancing reciprocal social behaviors. However, due to conflicting results from a number of pilot studies on the prosocial effects of exogenous oxytocin, this hypothesis remains controversial and inconclusive. SOARS-B is the best powered study to date to address this hypothesis and promises to improve our understanding of the safety and efficacy of intranasal oxytocin in the treatment of social deficits in children with ASD.",2020,"Plasma oxytocin and oxytocin receptor gene (OXTR) methylation level were measured at baseline, week 8, 24 and 36 to explore potential relationships between these biomarkers and treatment response.
","['individuals with autism spectrum disorder (ASD', 'children with ASD', '290 participants ages 3 to 17\u202fyears with a DSM-5 diagnosis of ASD']","['oxytocin', 'intranasal oxytocin', 'Oxytocin', 'open-label oxytocin', 'oxytocin or a matched placebo']","['Plasma oxytocin and oxytocin receptor gene (OXTR) methylation level', 'Reciprocal Social Behaviors (SOARS-B', 'reciprocal social behaviors (SOARS-B', 'social orienting', 'social difficulties']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0069841', 'cui_str': 'Oxytocin Receptor'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037397', 'cui_str': 'Social behavior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",290.0,0.0611497,"Plasma oxytocin and oxytocin receptor gene (OXTR) methylation level were measured at baseline, week 8, 24 and 36 to explore potential relationships between these biomarkers and treatment response.
","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Spanos', 'Affiliation': 'Duke Center for Autism and Brain Development, Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America. Electronic address: marina.spanos@duke.edu.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Chandrasekhar', 'Affiliation': 'Duke Center for Autism and Brain Development, Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Soo-Jeong', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': ""Seattle Children's Autism Center, Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, United States of America.""}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Hamer', 'Affiliation': 'Departments of Psychiatry and Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Bryan H', 'Initials': 'BH', 'LastName': 'King', 'Affiliation': ""Department of Psychiatry, Weill Institute for Neurosciences, University of California San Francisco, UCSF Benioff Children's Hospitals, San Francisco, CA, United States of America.""}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'McDougle', 'Affiliation': 'Lurie Center for Autism, Massachusetts General Hospital, Department of Psychiatry, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Kevin B', 'Initials': 'KB', 'LastName': 'Sanders', 'Affiliation': 'Neuroscience Product Development, F. Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Simon G', 'Initials': 'SG', 'LastName': 'Gregory', 'Affiliation': 'Duke Molecular Physiology Institute, Duke University School of Medicine, Durham, NC, United States of America; Department of Neurology, Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kolevzon', 'Affiliation': 'Seaver Autism Center for Research and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, United States of America.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Veenstra-VanderWeele', 'Affiliation': 'Department of Psychiatry, Columbia University, New York State Psychiatric Institute, Center for Autism and the Developing Brain, New York-Presbyterian Hospital, New York, NY, United States of America.'}, {'ForeName': 'Linmarie', 'Initials': 'L', 'LastName': 'Sikich', 'Affiliation': 'Duke Center for Autism and Brain Development, Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106103']
2001,32777456,The effect of disclosing life expectancy information on patients' prognostic understanding: secondary outcomes from a multicenter randomized trial of a palliative chemotherapy educational intervention.,"CONTEXT


Many advanced cancer patients have unrealistic prognostic expectations.
OBJECTIVES


We tested whether offering life expectancy (LE) statistics within palliative chemotherapy (PC) education promotes realistic expectations.
METHODS


In this multicenter trial, patients with advanced colorectal and pancreatic cancers initiating first or second line PC were randomized to usual care versus a PC educational tool with optional LE information. Surveys at 2 weeks and 3 months assessed patients' review of the LE module and their reactions; at 3 months, patients estimated their LE and reported occurrence of prognosis and end-of-life (EOL) discussions. Wilcoxon tests and proportional odds models evaluated between-arm differences in LE self-estimates, and how realistic those estimates were (based on cancer type and line of treatment).
RESULTS


From 2015-2017, 92 patients were randomized to the intervention and 94 to usual care. At baseline most patients (80.9%) wanted ""a lot"" or ""as much information as possible"" about the impact of chemotherapy on LE. Among patients randomized to the intervention, 52.0% reviewed the LE module by 2 weeks and 66.7% by 3 months - of whom 88.2% reported the information was important, 31.4% reported it was upsetting, and 3.9% regretted reviewing it. Overall, patients' LE self-estimates were very optimistic; 71.4% of colorectal cancer patients estimated >5yrs; 50% pancreatic patients estimated >2yrs. The intervention had no effect on the length or realism of patients' LE self-estimates, or on the occurrence of prognostic or EOL discussions.
CONCLUSIONS


Offering LE information within a PC educational intervention had no effect on patients' prognostic expectations.",2020,"The intervention had no effect on the length or realism of patients' LE self-estimates, or on the occurrence of prognostic or EOL discussions.
","['patients with advanced colorectal and pancreatic cancers initiating first or second line PC', ""patients' prognostic understanding"", 'From 2015-2017', 'advanced cancer patients', '92 patients']","['palliative chemotherapy educational intervention', 'palliative chemotherapy (PC) education', 'usual care versus a PC educational tool with optional LE information']","[""length or realism of patients' LE self-estimates, or on the occurrence of prognostic or EOL discussions"", 'occurrence of prognosis and end-of-life (EOL) discussions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}]",92.0,0.088382,"The intervention had no effect on the length or realism of patients' LE self-estimates, or on the occurrence of prognostic or EOL discussions.
","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Enzinger', 'Affiliation': 'Division of Population Sciences, Dana-Farber/Partners CancerCare, Boston, MA; Division of Gastrointestinal Oncology, Dana-Farber/Partners CancerCare, Boston, MA. Electronic address: andrea_enzinger@dfci.harvard.edu.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Uno', 'Affiliation': 'Division of Population Sciences, Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'McCleary', 'Affiliation': 'Division of Gastrointestinal Oncology, Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Frank', 'Affiliation': ""Susan F. Smith Center for Women's Cancers, Dana-Farber/Partners CancerCare, Boston, MA.""}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Sanoff', 'Affiliation': 'Division of Medical Oncology, University of North Carolina Lineberger Cancer Center, Chapel Hill, NC.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Van Loon', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Matin', 'Affiliation': 'Division of Medical Oncology, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bullock', 'Affiliation': 'Division of Medical Oncology, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Cronin', 'Affiliation': 'Division of Population Sciences, Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Bagley', 'Affiliation': 'Department of Nursing, Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Schrag', 'Affiliation': 'Division of Population Sciences, Dana-Farber/Partners CancerCare, Boston, MA; Division of Gastrointestinal Oncology, Dana-Farber/Partners CancerCare, Boston, MA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.07.025']
2002,32777479,"Transition to Advanced Therapies Among Elderly Patients Supported by Extracorporeal Membrane Oxygenation Therapy: Chouairi et al, ECMO in the Elderly.","BACKGROUND


While the utilization of extracorporeal membrane oxygenation (ECMO) continues to increase, very little is known about how age influences the transition to definitive advanced therapies.
METHODS


Using the National Inpatient Sample database from 2008 to 2017, we analyzed patients supported by ECMO for cardiogenic shock and separated patients into 2 age cohorts (<65 years and ≥65 years). Primary outcomes of interest included the proportion of patients undergoing orthotopic cardiac transplantation (OHT) and left ventricular assist device (LVAD) implantation.
RESULTS


Over the study period, we identified 16,132 hospitalizations with CS requiring ECMO support. Significantly fewer patients in the older group underwent OHT compared to the younger group (0.4% vs. 1.2%, P<0.001). Compared to the younger group, a lower proportion of those ≥65 years received an LVAD (3.7% vs. 5.8%, P<0.001). LVAD implantation increased over the study period in both age cohorts while OHT increased only in the <65 group (P<0.05, all). After multivariable adjustment, patients in the oldest age group were still less likely to receive an LVAD (Odds ratio [OR] 0.54; Confidence interval [CI]: 0.43-0.69, P<0.001), and continued to have the highest odds of in-hospital mortality (OR 1.53; CI:1.39-1.69, P<0.001).
CONCLUSIONS


Survival of patients ≥65 years requiring ECMO for cardiogenic shock is poor and less often includes transition to definitive advanced therapies. While we must stress that no patient should be denied ECMO based solely on age, we believe our results may be helpful for providers when counseling patients and their families.",2020,"Significantly fewer patients in the older group underwent OHT compared to the younger group (0.4% vs. 1.2%, P<0.001).","['Elderly Patients', 'for cardiogenic shock and separated patients into 2 age cohorts (<65 years and ≥65 years', '16,132 hospitalizations with CS requiring ECMO support', 'patients ≥65 years requiring']","['extracorporeal membrane oxygenation (ECMO', 'ECMO', 'OHT', 'Extracorporeal Membrane Oxygenation Therapy']","['hospital mortality', 'proportion of patients undergoing orthotopic cardiac transplantation (OHT) and left ventricular assist device (LVAD) implantation', 'LVAD implantation', 'OHT']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0574893', 'cui_str': 'Orthotopic'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0574893', 'cui_str': 'Orthotopic'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",,0.0520887,"Significantly fewer patients in the older group underwent OHT compared to the younger group (0.4% vs. 1.2%, P<0.001).","[{'ForeName': 'Fouad', 'Initials': 'F', 'LastName': 'Chouairi', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Saraschandra', 'Initials': 'S', 'LastName': 'Vallabhajosyula', 'Affiliation': 'Department of Cardiovascular Medicine and Division of Pulmonary and Critical Care Medicine, Department of Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Clancy', 'Initials': 'C', 'LastName': 'Mullan', 'Affiliation': 'Section of Cardiac Surgery, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': 'Section of Cardiac Surgery, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Arnar', 'Initials': 'A', 'LastName': 'Geirsson', 'Affiliation': 'Section of Cardiac Surgery, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Nihar R', 'Initials': 'NR', 'LastName': 'Desai', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, CT; Center for Outcomes Research & Evaluation (CORE), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Ahmad', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, CT; Center for Outcomes Research & Evaluation (CORE), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'P Elliott', 'Initials': 'PE', 'LastName': 'Miller', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, CT; Yale National Clinician Scholars Program, Yale University School of Medicine, New Haven, CT. Electronic address: Elliott.miller@yale.edu.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2020.07.019']
2003,32777552,Evolution of endoscopic lesions in steroid-refractory acute severe ulcerative colitis responding to infliximab or cyclosporine.,"BACKGROUND/AIMS


Few data on the evolution of endoscopic findings are available in patients with acute severe ulcerative colitis (ASUC). The aim of this study was to describe this evolution in a prospective cohort.
METHODS


Patients admitted for a steroid-refractory ASUC and included in a randomized trial comparing infliximab and cyclosporine were eligible if they achieved steroid-free clinical remission at day 98. Flexible sigmoidoscopies were performed at baseline, days 7, 42 and 98. Ulcerative colitis endoscopic index of severity (UCEIS) and its sub-scores - vascular pattern, bleeding and ulceration/erosion - were post-hoc calculated. Global endoscopic remission was defined by a UCEIS of 0, and partial endoscopic remission by any UCEIS sub-score of 0.
RESULTS


Among the 55 patients analyzed (29 infliximab and 26 cyclosporine), 49 (83%) had UCEIS ≥6 at baseline at baseline. Partial endoscopic remission rates were higher for bleeding than for vascular pattern and for ulcerations/erosions at day 7 (20% vs. 4% and 5% (n=55); p=0.004 and p=0.04), for bleeding and ulceration/erosion than for vascular pattern at day 42 [63% and 65% vs. 33% (n=54); p<0.001 for both] and at day 98 [78% and 92% vs. 56% (n=50); p=0.007 and p<0.001]. Global endoscopic remission rates at day 98 were higher in patients treated with infliximab than with cyclosporine [73% vs. 25% (n=26 and 24); p<0.001].
CONCLUSION


In steroid-refractory ASUC patients responding to a second-line medical therapy, endoscopic remission process started with bleeding remission and was not achieved in half the patients at day 98 for vascular pattern. Infliximab provided a higher endoscopic remission rate than cyclosporine at day 98.",2020,"Partial endoscopic remission rates were higher for bleeding than for vascular pattern and for ulcerations/erosions at day 7 (20% vs. 4% and 5% (n=55); p=0.004 and p=0.04), for bleeding and ulceration/erosion than for vascular pattern at day 42 [63% and 65% vs. 33% (n=54); p<0.001 for both] and at day 98 [78% and 92% vs. 56% (n=50); p=0.007 and p<0.001].","['patients with acute severe ulcerative colitis (ASUC', 'Patients admitted for a steroid-refractory ASUC and included in a randomized trial comparing']","['infliximab and cyclosporine', 'infliximab or cyclosporine', 'Infliximab', 'infliximab', 'cyclosporine']","['Global endoscopic remission', 'Global endoscopic remission rates', 'Ulcerative colitis endoscopic index of severity (UCEIS) and its sub-scores - vascular pattern, bleeding and ulceration/erosion ', 'Partial endoscopic remission rates', 'ulcerations/erosions', 'endoscopic remission rate', 'bleeding and ulceration/erosion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.13872,"Partial endoscopic remission rates were higher for bleeding than for vascular pattern and for ulcerations/erosions at day 7 (20% vs. 4% and 5% (n=55); p=0.004 and p=0.04), for bleeding and ulceration/erosion than for vascular pattern at day 42 [63% and 65% vs. 33% (n=54); p<0.001 for both] and at day 98 [78% and 92% vs. 56% (n=50); p=0.007 and p<0.001].","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Laharie', 'Affiliation': ""CHU de Bordeaux, Centre Medico-chirurgical Magellan, Hôpital Haut-Lévêque, service d'hépato-gastroentérologie et oncologie digestive; Université de Bordeaux; INSERM CIC 1401; Bordeaux, France. Electronic address: david.laharie@chu-bordeaux.fr.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bourreille', 'Affiliation': ""CHU de Nantes, Hôtel-Dieu, Hépato-Gastroentérologie, Institut des Maladies de l'Appareil Digestif, F-44093 Nantes, France.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Branche', 'Affiliation': ""CHRU de Lille, Hôpital Claude Huriez, Service des maladies de l'appareil digestif - Endoscopie digestive, F-59037 Lille, France.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Allez', 'Affiliation': ""Hôpital Saint-Louis, service d'Hépato-Gastroentérologie, APHP - Université Paris VII, F-75010 Paris, France.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Bouhnik', 'Affiliation': 'Hôpital Beaujon, Gastroentérologie, MICI et Assistance Nutritive, APHP - Université Paris VII, F-92110 Clichy, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Filippi', 'Affiliation': ""CHU de Nice, Hôpital de l'Archet 2, Service de Gastroentérologie et Nutrition Clinique, F-06202 Nice, France.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Zerbib', 'Affiliation': ""CHU de Bordeaux, Centre Medico-chirurgical Magellan, Hôpital Haut-Lévêque, service d'hépato-gastroentérologie et oncologie digestive; Université de Bordeaux; INSERM CIC 1401; Bordeaux, France.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Savoye', 'Affiliation': 'CHU de Rouen, Hôpital Charles Nicolle, service de Gastroentérologie, UMR 1073"", Normandie Université-Rouen, F-76031 Rouen, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vuitton', 'Affiliation': 'CHU de Besançon, Hôpital Jean Minjoz, Service de Gastroentérologie, F-25030 Besançon, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Moreau', 'Affiliation': 'CHU de Toulouse, Hôpital Rangueil, Service de Gastro-entérologie et Nutrition, F-31059 Toulouse, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Amiot', 'Affiliation': ""Hôpital Henri Mondor, Service d'Hépato-gastroentérologie, APHP - Université Créteil, EC2M3-EA 7375, F-94010 Créteil, France.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Beaugerie', 'Affiliation': ""INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpital Saint-Antoine, Department of Gastroenterology, F75012, Paris, France.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ricart', 'Affiliation': 'Hospital. Clinic, Gastroenterology department, IDIBAPS, CIBEREHD, Barcelona-08036, Spain.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Dewit', 'Affiliation': ""UCL Saint Luc, Service d'Hépato-Gastroentérologie, 1200 Brussels, Belgium.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lopez-Sanroman', 'Affiliation': 'Hospital Ramon y Cajal, Unidad de EII / IBD Unit, Servicio de Gastroenterología y Hepatología, E-28034 Madrid, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fumery', 'Affiliation': ""CHU Amiens, service d'Hépato-Gastroentérologie, and Peritox UMR I-01, F-80000 Amiens, France.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Carbonnel', 'Affiliation': ""Hôpital Bicêtre, service d'Hépato-Gastroentérologie, APHP - Université Paris Sud 11, F-94275 Le Kremlin Bicêtre, France.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Buisson', 'Affiliation': ""Université Clermont Auvergne, Inserm U1071, M2iSH, USC-INRA 2018, 3iHP, CHU Clermont-Ferrand, Service d'Hépato-Gastroentérologie, Clermont-Ferrand, France.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Coffin', 'Affiliation': ""Hôpital Louis Mourier, service d'Hépato-Gastroentérologie, Pôle Maladie Appareil Digestif, APHP - Université Paris VII, F-92700 Colombes, France.""}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Roblin', 'Affiliation': 'CHU de Saint-Etienne, Hôpital Nord, Service de Gastro-entérologie et Hépatologie, F-42277 Saint-Etienne, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'van Assche', 'Affiliation': 'University Hospital Leuven, Division of Gastroenterology and Hepatology, Leuven, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Esteve', 'Affiliation': 'Hospital Universitari Mútua de Terrassa, Department of Gastroenterology; Catalonia. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD). Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Farkkila', 'Affiliation': 'Helsinki University, and Helsinki University Central Hospital, Clinic of Gastroenterology, 00029 HUS, Finland.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Gisbert', 'Affiliation': 'Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spai.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Marteau', 'Affiliation': 'Sorbonne Université; Service Hépato-gastroentérologie Hôpital Tenon APHP - Paris, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nahon', 'Affiliation': ""CHI Le Raincy Montfermeil, Service d'Hépato-gastroentérologie, F-93370 Montfermeil, France.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'de Vos', 'Affiliation': 'Ghent University Hospital, B-9000 Gent, Belgium.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Peyrin-Biroulet', 'Affiliation': 'Inserm U1256 NGERE and Department of Hepato-Gastroenterology, University Hospital of Nancy, Lorraine University, 54511 Vandoeuvre-lès-Nancy, France.'}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Mary', 'Affiliation': 'UMR-S- 1153 Inserm, Equipe ECSTRA, Denis Diderot - Paris 7 University, Hôpital Saint-Louis, Paris, France.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.08.001']
2004,32777706,Comparison of the efficacy and safety of recombinant human growth hormone in treating idiopathic short stature and growth hormone deficiency in children.,"PURPOSE


The present study aimed to compare the efficacy and safety of recombinant human growth hormone (rhGH) therapy between children with idiopathic short stature (ISS) and growth hormone deficiency (GHD).
METHODS


A total of 150 pediatric patients with ISS and 153 pediatric patients with GHD who received rhGH treatment for more than one year from 2005 to 2016 were enrolled. Growth velocity (GV); height standard deviation (HtSD); insulin-like growth factor-1 standard deviation (IGF-1SD); body mass index (BMI); and the incidence of fasting hyperglycemia, fasting hyperinsulinemia, and hypothyroidism were recorded and compared.
RESULTS


At the beginning of treatment, chronological age, bone age, height, and BMI were not statistically significant between the two groups. rhGH dosage in ISS was significantly higher compared with GHD (P = 0). GV from half a year to three years after rhGH therapy was higher in the GHD group compared with the ISS group, but the differences were not statistically significant (P > 0 .05). HtSD increased in the two groups after rhGH therapy. HtSD at the beginning and after three years of therapy was not different between groups except for after half a year of therapy. HtSD in patients with ISS was significantly higher compared with GHD (P < 0 .05). The incidence of hypothyroidism was significantly higher in the GHD group compared with the ISS group (13.72% vs. 6.0%; P < 0.05). Moreover, the incidence of hyperinsulinemia was significantly higher in the ISS group compared with the GHD group (15.33% vs. 7.84%; P < 0 .05).
CONCLUSIONS


rhGH increases growth in children with ISS and GHD. Fasting insulin and thyroid function were closely monitored for long-term follow up.",2020,"GV from half a year to three years after rhGH therapy was higher in the GHD group compared with the ISS group, but the differences were not statistically significant (P > 0 .05).","['children with ISS and GHD', 'children with idiopathic short stature (ISS) and growth hormone deficiency (GHD', 'children', 'patients with ISS', '150 pediatric patients with ISS and 153 pediatric patients with GHD who received rhGH treatment for more than one year from 2005 to 2016 were enrolled']","['recombinant human growth hormone', 'GHD', 'recombinant human growth hormone (rhGH) therapy']","['incidence of hyperinsulinemia', 'Fasting insulin and thyroid function', 'efficacy and safety', 'Growth velocity (GV); height standard deviation (HtSD); insulin-like growth factor-1 standard deviation (IGF-1SD); body mass index (BMI); and the incidence of fasting hyperglycemia, fasting hyperinsulinemia, and hypothyroidism', 'incidence of hypothyroidism', 'HtSD', 'rhGH dosage in ISS']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1740819', 'cui_str': 'Idiopathic short stature'}, {'cui': 'C0271561', 'cui_str': 'Growth hormone deficiency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C4082117', 'cui_str': 'One year'}]","[{'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0271561', 'cui_str': 'Growth hormone deficiency'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2609269', 'cui_str': 'Fasting hyperglycaemia'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1740819', 'cui_str': 'Idiopathic short stature'}]",150.0,0.0207075,"GV from half a year to three years after rhGH therapy was higher in the GHD group compared with the ISS group, but the differences were not statistically significant (P > 0 .05).","[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Hou', 'Affiliation': 'Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Han-Hua', 'Initials': 'HH', 'LastName': 'Lin', 'Affiliation': 'Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Xiao-Ping', 'Initials': 'XP', 'LastName': 'Luo', 'Affiliation': 'Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Yan-Qin', 'Initials': 'YQ', 'LastName': 'Ying', 'Affiliation': 'Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China. Electronic address: yingyanqin@126.com.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2020.101331']
2005,32777710,Community-level interventions for pre-eclampsia (CLIP) in Pakistan: A cluster randomised controlled trial.,"OBJECTIVES


To reduce all-cause maternal and perinatal mortality and major morbidity through Lady Health Worker (LHW)-facilitated community engagement and early diagnosis, stabilization and referral of women with preeclampsia, an important contributor to adverse maternal and perinatal outcomes given delays in early detection and initial management.
STUDY DESIGN


In the Pakistan Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomized controlled trial (NCT01911494), LHWs engaged the community, recruited pregnant women from 20 union councils (clusters), undertook mobile health-guided clinical assessment for preeclampsia, and referral to facilities after stabilization.
MAIN OUTCOME MEASURES


The primary outcome was a composite of maternal, fetal and newborn mortality and major morbidity.
FINDINGS


We recruited 39,446 women in intervention (N = 20,264) and control clusters (N = 19,182) with minimal loss to follow-up (3∙7% vs. 4∙5%, respectively). The primary outcome did not differ between intervention (26·6%) and control (21·9%) clusters (adjusted odds ratio, aOR, 1∙20 [95% confidence interval 0∙84-1∙72]; p = 0∙31). There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77); early (0·95 [0·82-1·09]; p = 0·46) or late neonatal deaths (1·23 [0·97-1·55]; p = 0·09); or neonatal morbidity (1·22 [0·77, 1·96]; p = 0·40). Improvements in outcome rates were observed with 4-7 (p = 0·015) and ≥8 (p < 0·001) (vs. 0) CLIP contacts.
INTERPRETATION


The CLIP intervention was well accepted by the community and implemented by LHWs. Lack of effects on adverse outcomes could relate to quality care for mothers with pre-eclampsia in health facilities. Future strategies for community outreach must also be accompanied by health facility strengthening.
FUNDING


The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).",2020,"There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77);","['39,446 women in intervention (N\xa0=\xa020,264) and control clusters (N\xa0=\xa019,182) with minimal loss to follow-up (3∙7% vs. 4∙5%, respectively', 'mothers with pre-eclampsia in health facilities', 'recruited pregnant women from 20 union councils (clusters), undertook mobile health-guided clinical assessment for preeclampsia, and referral to facilities after stabilization', 'pre-eclampsia (CLIP) in Pakistan', 'women with preeclampsia']","['Community-level interventions', 'CLIP intervention']","['late neonatal deaths', 'neonatal morbidity', 'outcome rates', 'maternal death', 'reduction in stillbirths', 'composite of maternal, fetal and newborn mortality and major morbidity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}]","[{'cui': 'C0455987', 'cui_str': 'Late neonatal death'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",39446.0,0.261501,"There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77);","[{'ForeName': 'Rahat N', 'Initials': 'RN', 'LastName': 'Qureshi', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Sheikh', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Hoodbhoy', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver, BC V6Z 1Y6, Canada.""}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver, BC V6Z 1Y6, Canada.""}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan; Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto, ON M5G 2L3, Canada. Electronic address: zulfiqar.bhutta@aku.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'the CLIP Pakistan Trial Working Group (Table S1).'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.07.011']
2006,32777737,Evaluation of efficacy and safety of rituximab in combination with mycophenolate mofetil in patients with nonspecific interstitial pneumonia non-responding to a first-line immunosuppressive treatment (EVER-ILD): A double-blind placebo-controlled randomized trial.,"INTRODUCTION


Nonspecific interstitial pneumonia (NSIP) are rare but severe diseases, with high mortality and morbidity, with no effective pharmacological treatment allowing for long-term remission, and therefore no clear therapeutic recommendations. Classic immunosuppressants are used as first-line treatment, with only one third of patients being responders and no clear recommendations exist for the choice of the second-line therapy. The EvER-ILD study is the first one to prospectively evaluate the efficacy and safety of rituximab and mycophenolate mofetil (MMF) versus placebo and MMF in a broad range of NSIP patients that did not respond to a first-line therapy. A pharmacokinetic-pharmacodynamic analysis based on rituximab serum concentrations will allow identification of potential factors associated with therapeutic response and/or adverse effects.
METHODS


EvER-ILD study is a French multicenter, prospective, randomized, double blind, placebo-controlled, superiority trial. Patients with severe and progressive NSIP non-responding to a first line immunosuppressive treatment will be randomized in 2 groups of treatment: one course of rituximab plus 6 months MMF (RTX-MMF group) and one course of placebo plus 6 months MMF (Placebo-MMF group). The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months. Several clinical, biological, and quality of life secondary outcomes will be measured at 3, 6 and 12 months. A sample size of 122 patients (61 patients per group) would allow to show a point difference between groups in the change of FVC at 6 months, based on a common standard deviation for FVC change of 8% with a power of 90%, alpha 5% two-sided, and anticipating an extreme 10% drop-out rate.
ETHICS AND DISSEMINATION


The protocol was approved by the French Research Ethics Committee (CPP Tours Ouest 1 2016-R28) on November 10, 2016, and by the French competent authority (ANSM, reference 160771A-22) on December 1st, 2016. This article refers to protocol V2, dated November 18, 2016. An independent data safety monitoring board will review safety and tolerability data for the duration of the trial. Results will be disseminated via peer reviewed publication and presentation at international conferences.
TRIAL REGISTRATION NUMBER


NCT02990286 (clinicaltrials.gov), EudraCT 2016-003026-16 (European Medicines agency).",2020,"The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months.","['2016-003026-16 (European Medicines agency', '122 patients (61 patients per group', 'patients with nonspecific interstitial pneumonia non-responding to a first-line immunosuppressive treatment (EVER-ILD', 'Patients with severe and progressive NSIP non-responding to a first line immunosuppressive treatment']","['EudraCT', 'mycophenolate mofetil', 'rituximab and mycophenolate mofetil (MMF) versus placebo and MMF', 'rituximab plus 6 months MMF (RTX-MMF group) and one course of placebo plus 6 months MMF (Placebo-MMF group', 'rituximab', 'placebo']","['change in Forced Vital Capacity (FVC, % of predicted']","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1290344', 'cui_str': 'Nonspecific interstitial pneumonia'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0073081', 'cui_str': 'resiniferatoxin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}]",,0.378227,"The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bejan-Angoulvant', 'Affiliation': 'Service de Pharmacologie médicale, CHRU de Tours, Hôpital Bretonneau, Université de Tours, Tours, France.'}, {'ForeName': 'J-Marc', 'Initials': 'JM', 'LastName': 'Naccache', 'Affiliation': 'AP-HP, Hôpital Tenon, service de pneumologie, Site constitutif du centre de référence pour les maladies pulmonaires rares OrphaLung, and Sorbonne Université, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Caille', 'Affiliation': 'Inserm CIC1415, CHRU Tours, Université de Tours, Université de Nantes, SPHERE, U1246, Tours, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Borie', 'Affiliation': 'AP-HP, service de pneumologie, centre de compétences pour les maladies pulmonaires rares, Hôpital Bichat, Paris, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nunes', 'Affiliation': 'Service de pneumologie, centre constitutif pour les maladies pulmonaires rares, hôpital Avicenne, CHU Paris Seine-Saint-Denis, Bobigny, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ferreira', 'Affiliation': 'Service de Pneumologie, CHRU de Tours, Centre de compétences des maladies pulmonaires rares de la région Centre, Hôpital Bretonneau, Tours, France; Université de Tours, CEPR Inserm U1100, Tours, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cadranel', 'Affiliation': 'AP-HP, Hôpital Tenon, service de pneumologie, Site constitutif du centre de référence pour les maladies pulmonaires rares OrphaLung, and Sorbonne Université, Paris, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Crestani', 'Affiliation': 'AP-HP, service de pneumologie, centre de compétences pour les maladies pulmonaires rares, Hôpital Bichat, Paris, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Cottin', 'Affiliation': 'Service de Pneumologie, Centre national coordonnateur de référence des maladies pulmonaires rares, Hôpital Louis Pradel, Hospices civils de Lyon, UMR 754, Université Claude Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Marchand-Adam', 'Affiliation': 'Service de Pneumologie, CHRU de Tours, Centre de compétences des maladies pulmonaires rares de la région Centre, Hôpital Bretonneau, Tours, France; Université de Tours, CEPR Inserm U1100, Tours, France. Electronic address: s.marchandadam@univ-tours.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Respiratory medicine and research,['10.1016/j.resmer.2020.100770']
2007,32777896,Effective dose of intravenous oxycodone depending on sex and age for attenuation of intubation-related hemodynamic responses.,"BACKGROUND/AIM


Preoperative intravenous oxycodone may help to prevent or attenuate intubation-related hemodynamic responses (IRHRs), but its pharmacokinetics differ according to age and sex. Therefore, we investigated the 95% effective dose (ED95) of intravenous oxycodone for attenuating all IRHRs, depending on age and sex of the study population.
MATERIALS AND METHODS


All patients were allocated to one of 6 groups: 1) 20?40 year old males, 2) 41?65 year old males, 3) 66?80 year old males, 4) 20?40 year old females, 5) 41?65 year old females, and 6) 66?80 year old females (groups YM, OM, EM, YF, OF, and EF, respectively). Using Dixon?s up-and-down method, the first patient in each group was injected with intravenous oxycodone (0.1 mg kg-1) slowly, 20 min before intubation. The subsequent patient received the next oxycodone dose, which was decreased or increased by 0.01 mg kg-1, depending on the ?success? or ?failure? of attenuation of all IRHRs to within 20% of the baseline values, at 1 min after intubation in the previous patient. After obtaining eight crossover points, predictive ED95 was estimated with probit regression analysis.
RESULTS


ED95 varied greatly according to age and sex. ED95 was 0.133 mg kg-1, 0.181 mg kg-1, 0.332 mg kg-1, 0.183 mg kg-1, 0.108 mg kg-1, and 0.147 mg kg-1 in groups YM, OM, EM, YF, OF, and EF, respectively.
CONCLUSION


ED95 required is higher in males with increasing age, but is ambiguous for females. ED95 is higher in males than in females over 40 years of age, but is higher in females than in males under 41 year of age. However, after considering the age and sex of the study population, these results can be used as reference doses for further studies to verify the clinical effects of oxycodone for attenuating all IRHRs.",2020,"ED95 was 0.133 mg kg-1, 0.181 mg kg-1, 0.332 mg kg-1, 0.183 mg kg-1, 0.108 mg kg-1, and 0.147 mg kg-1 in groups YM, OM, EM, YF, OF, and EF, respectively.
","['All patients were allocated to one of 6 groups: 1) 20?40 year old males, 2) 41?65 year old males, 3) 66?80 year old males, 4) 20?40 year old females, 5) 41?65 year old females, and 6) 66?80 year old females (groups YM, OM, EM, YF, OF, and EF, respectively', 'males than in females over 40 years of age, but is higher in females than in males under 41 year of age']","['oxycodone', 'intravenous oxycodone']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]",[],,0.114997,"ED95 was 0.133 mg kg-1, 0.181 mg kg-1, 0.332 mg kg-1, 0.183 mg kg-1, 0.108 mg kg-1, and 0.147 mg kg-1 in groups YM, OM, EM, YF, OF, and EF, respectively.
","[{'ForeName': 'Keum Young', 'Initials': 'KY', 'LastName': 'So', 'Affiliation': ''}, {'ForeName': 'Ki Tae', 'Initials': 'KT', 'LastName': 'Jung', 'Affiliation': ''}, {'ForeName': 'Bo Hyun', 'Initials': 'BH', 'LastName': 'Jang', 'Affiliation': ''}, {'ForeName': 'Sang Hun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': ''}]",Turkish journal of medical sciences,['10.3906/sag-2004-63']
2008,32777923,Effects of Process-Based Cognitive Training on Memory in the Healthy Elderly and Patients with Mild Cognitive Impairment: A Randomized Controlled Trial.,"OBJECTIVE


This study investigated the effects of process-based cognitive training that targets working memory and cognitive control on memory improvement in healthy elderly individuals and patients with mild cognitive impairment (MCI).
METHODS


Forty healthy subjects and 40 patients with MCI were randomly assigned to either the intervention or control group. The intervention group received 12 sessions of designated cognitive training. The control group did not receive cognitive training. A memory test was administered pre-intervention, post-intervention, and 4 weeks after the intervention. Additional comprehensive neuropsychological tests were also administered including a depression scale questionnaire.
RESULTS


Performance in attention and working memory, which are directly related to the training domains, and global cognitive function were improved in the intervention group after training. In memory tests, interference by irrelevant stimuli was reduced and recognition memory was improved after the intervention. Furthermore, cognitive training ameliorated depressive symptoms. These training effects were not dependent on MCI status.
CONCLUSION


Process-based cognitive training that targets working memory and cognitive control effectively improves memory processes including retrograde interference and recognition, as well as depressive symptoms associated with aging in healthy elderly individuals and patients with MCI.",2020,"RESULTS


Performance in attention and working memory, which are directly related to the training domains, and global cognitive function were improved in the intervention group after training.","['Forty healthy subjects and 40 patients with MCI', 'Healthy Elderly and Patients with Mild Cognitive Impairment', 'healthy elderly individuals and patients with MCI', 'healthy elderly individuals and patients with mild cognitive impairment (MCI']","['cognitive training', 'Process-based cognitive training', '12 sessions of designated cognitive training', 'process-based cognitive training that targets working memory and cognitive control', 'Process-Based Cognitive Training']","['global cognitive function', 'depression scale questionnaire', 'recognition memory', 'depressive symptoms']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",40.0,0.0209777,"RESULTS


Performance in attention and working memory, which are directly related to the training domains, and global cognitive function were improved in the intervention group after training.","[{'ForeName': 'Minyoung', 'Initials': 'M', 'LastName': 'Shin', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ahee', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'A Young', 'Initials': 'AY', 'LastName': 'Cho', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Minam', 'Initials': 'M', 'LastName': 'Son', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yun-Hee', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}]",Psychiatry investigation,['10.30773/pi.2019.0225']
2009,32777986,Feasibility and concurrent validity of a cardiorespiratory fitness test based on the adaptation of the original 20 m shuttle run: The 20 m shuttle run with music.,"The purpose was to examine the feasibility of the 20m shuttle run test with music and to test its concurrent validity with the original 20m shuttle run test. A total of 386 adolescents (14.5±1.6 years old, 48.9% boys) participated in our study. A self-reported questionnaire was used to assess student's perception about the 20m shuttle run test with music and the original and to assess perceived exertion. Participants performed randomly the 20m shuttle run test with music and original two weeks apart. Average and maximum heart rate were monitored with heart rate monitors. The 20m shuttle run with music was a feasible test for measuring cardiorespiratory fitness in adolescents. The concurrent validity showed mean differences of 5.1±14.6 for shuttles, 0.3±0.8 km/h for speed, 0.5±4.1 for stages, and 1.5±4.1 for VO2max (all p<0.001) in favour of the 20m shuttle run with music vs. the original 20m shuttle run test. Mean difference for the rating of perceived exertion was 0.4±2.5 points (p=0.003). No significant difference was found between boys and girls. In conclusion, the 20mSRT-music is feasible and presents a good concurrent validity in adolescents, independently of the sex and it will be an alternative and good approach to assess cardiorespiratory fitness.",2020,Mean difference for the rating of perceived exertion was 0.4±2.5 points (p=0.003).,"['386 adolescents (14.5±1.6 years old, 48.9% boys) participated in our study', 'adolescents']",[],"['Average and maximum heart rate', 'rating of perceived exertion']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",386.0,0.0364088,Mean difference for the rating of perceived exertion was 0.4±2.5 points (p=0.003).,"[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Lamoneda', 'Affiliation': 'PA-Help ""Physical Activity for Health Promotion"" Research Group, Junta de Andalucia , Jerez, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Huertas-Delgado', 'Affiliation': 'PA-Help ""Physical Activity for Health Promotion"" Research Group, La Inmaculada Teacher Training Centre, University of Granada , Granada, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cadenas-Sanchez', 'Affiliation': 'MOVE-IT Research Group, Department of Physical Education, Faculty of Education Sciences, University of Cádiz , Cádiz, Spain.'}]",Journal of sports sciences,['10.1080/02640414.2020.1804785']
2010,32777998,"L-theanine improves neurophysiological measures of attention in a dose-dependent manner: a double-blind, placebo-controlled, crossover study.","Objective:  L-theanine, a non-proteinic amino acid found in tea, is known to enhance attention particularly in high doses, with no reported adverse effects. We aimed to determine whether oral administration of L-theanine acutely enhances neurophysiological measures of selective attention in a dose-dependent manner.  Methods:  In a double-blind, placebo-controlled, counterbalanced, 4-way crossover study in a group of 27 healthy young adults, we compared the effects of 3 doses of L-theanine (100, 200 and 400 mg) with a placebo (distilled water) on latencies of amplitudes of attentive and pre-attentive cognitive event-related potentials (ERPs) recorded in an auditory stimulus discrimination task, before and 50 min after dosing.  Results:  Compared to the placebo, 400 mg of theanine showed a significant reduction in the latency of the parietal P3b ERP component ( p  < 0.05), whereas no significant changes were observed with lower doses. A subsequent exploratory regression showed that each 100-mg increase in dose reduces the P3b latency by 4 ms ( p  < 0.05). No dose-response effect was observed in P3b amplitude, pre-attentive ERP components or reaction time.  Discussion:  The findings indicate L-theanine can increase attentional processing of auditory information in a dose-dependent manner. The linear dose-response attentional effects we observed warrant further studies with higher doses of L-theanine.",2020,"Compared to the placebo, 400 mg of theanine showed a significant reduction in the latency of the parietal P3b ERP component ( p  < 0.05), whereas no significant changes were observed with lower doses.",['27 healthy young adults'],"['L-theanine', 'placebo (distilled water', 'placebo']","['P3b amplitude, pre-attentive ERP components or reaction time', 'latency of the parietal P3b ERP component', 'latencies of amplitudes of attentive and pre-attentive cognitive event-related potentials (ERPs', 'P3b latency', 'attentional processing of auditory information']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0076380', 'cui_str': 'theanine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015214', 'cui_str': 'Evoked potential'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}]",27.0,0.196322,"Compared to the placebo, 400 mg of theanine showed a significant reduction in the latency of the parietal P3b ERP component ( p  < 0.05), whereas no significant changes were observed with lower doses.","[{'ForeName': 'Tharaka L', 'Initials': 'TL', 'LastName': 'Dassanayake', 'Affiliation': 'Department of Physiology, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.'}, {'ForeName': 'Chanaka N', 'Initials': 'CN', 'LastName': 'Kahathuduwa', 'Affiliation': 'Department of Psychiatry, School of Medicine, Texas Tech University Health Sciences Center, Lubbock, TX, USA.'}, {'ForeName': 'Vajira S', 'Initials': 'VS', 'LastName': 'Weerasinghe', 'Affiliation': 'Department of Physiology, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.'}]",Nutritional neuroscience,['10.1080/1028415X.2020.1804098']
2011,32778008,Young adult outcomes associated with lower cognitive functioning in childhood related to iron-fortified formula in infancy.,"Objective:  This study examined how the lower cognitive skills in children who consumed iron-fortified formula in infancy relate to outcomes in young adulthood.  Methods:  Participants were 443 Chilean young adults ( M  age = 21.2y, 55% female) who took part in a randomized controlled iron-deficiency anemia preventive trial during infancy (6-12 m). Slightly over half of participants ( n  = 237) received iron-fortified formula (12.7 mg/L) and 206 received a low-iron formula (2.3 mg/L). Spatial memory, IQ, and visual-motor integration were measured at age 10, and neurocognition, emotion regulation, educational level, and attainment of adult developmental milestones were assessed at age 21.  Results:  Consumption of iron-fortified formula in infancy was associated with poorer performance on neurocognitive tests in childhood, and these effects related to poorer neurocognitive, emotional, and educational outcomes in young adulthood. Dosage effects associated with consumption of iron-fortified formula were found for lower educational attainment and, marginally, slower mental processing. Those who received iron-fortified formula and had low age 10 cognitive abilities performed most poorly on neurocognitive tests at age 21.  Conclusion:  Findings suggest that the long-term development of infants who consume iron-fortified formula may be adversely affected. Clinical Trials number: NCT01166451.",2020,"Dosage effects associated with consumption of iron-fortified formula were found for lower educational attainment and, marginally, slower mental processing.","['Participants were 443 Chilean young adults ( M  age\u2009=\u200921.2y, 55% female) who took part in a randomized controlled iron-deficiency anemia preventive trial during infancy (6-12\u2005m', 'young adulthood', 'children who consumed iron-fortified formula in infancy relate to outcomes in young adulthood']","['low-iron formula', 'iron-fortified formula']","['Spatial memory, IQ, and visual-motor integration', 'neurocognition, emotion regulation, educational level, and attainment of adult developmental milestones', 'poorer neurocognitive, emotional, and educational outcomes']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0700597', 'cui_str': 'Adulthood'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0860975', 'cui_str': 'Iron low'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}]","[{'cui': 'C0814087', 'cui_str': 'Spatial Memory'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",443.0,0.117798,"Dosage effects associated with consumption of iron-fortified formula were found for lower educational attainment and, marginally, slower mental processing.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'East', 'Affiliation': 'Department of Pediatrics, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Jenalee', 'Initials': 'J', 'LastName': 'Doom', 'Affiliation': 'Department of Psychology, University of Denver, Denver, CO, USA.'}, {'ForeName': 'Estela', 'Initials': 'E', 'LastName': 'Blanco', 'Affiliation': 'Department of Pediatrics, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Burrows', 'Affiliation': 'Institute of Nutrition and Food Technology, University of Chile, Santiago, Chile.'}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Lozoff', 'Affiliation': 'Department of Pediatrics, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Gahagan', 'Affiliation': 'Department of Pediatrics, University of California, San Diego, La Jolla, CA, USA.'}]",Nutritional neuroscience,['10.1080/1028415X.2020.1804099']
2012,32778102,A cluster randomized controlled trial for the Evaluation of routinely Measured PATient reported outcomes in HemodialYsis care (EMPATHY): a study protocol.,"BACKGROUND


Kidney failure requiring dialysis is associated with poor health outcomes and health-related quality of life (HRQL). Patient-reported outcome measures (PROMs) capture symptom burden, level of functioning and other outcomes from a patient perspective, and can support clinicians to monitor disease progression, address symptoms, and facilitate patient-centered care. While evidence suggests the use of PROMs in clinical practice can lead to improved patient experience in some settings, the impact on patients' health outcomes and experiences is not fully understood, and their cost-effectiveness in clinical settings is unknown. This study aims to fill these gaps by evaluating the effectiveness and cost-effectiveness of routinely measuring PROMs on patient-reported experience, clinical outcomes, HRQL, and healthcare utilization.
METHODS


The EMPATHY trial is a pragmatic multi-centre cluster randomized controlled trial that will implement and evaluate the use of disease-specific and generic PROMs in three kidney care programs in Canada. In-centre hemodialysis units will be randomized into four groups, whereby patients: 1) complete a disease-specific PROM; 2) complete a generic PROM; 3) complete both types of PROMs; 4) receive usual care and do not complete any PROMs. While clinical care pathways are available to all hemodialysis units in the study, for the three active intervention groups, the results of the PROMs will be linked to treatment aids for clinicians and patients. The primary outcome of this study is patient-provider communication, assessed by the Communication Assessment Tool (CAT). Secondary outcomes include patient management and symptoms, use of healthcare services, and the costs of implementing this intervention will also be estimated. The present protocol fulfilled the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) checklist.
DISCUSSION


While using PROMs in clinical practice is supported by theory and rationale, and may engage patients and enhance their role in decisions regarding their care and outcomes, the best approach of their use is still uncertain. It is important to rigorously evaluate such interventions and investments to ensure they provide value for patients and health systems.
TRIAL REGISTRATION


Protocol version (1.0) and trial registration data are available on www.clinicaltrials.gov , identifier: NCT03535922 , registered May 24, 2018.",2020,"Secondary outcomes include patient management and symptoms, use of healthcare services, and the costs of implementing this intervention will also be estimated.",['three kidney care programs in Canada'],['usual care and do not complete any PROMs'],"['patient management and symptoms, use of healthcare services, and the costs of implementing this intervention will also be estimated', 'patient-provider communication, assessed by the Communication Assessment Tool (CAT', 'outcome measures (PROMs) capture symptom burden, level of functioning and other outcomes from a patient perspective, and can support clinicians to monitor disease progression, address symptoms, and facilitate patient-centered care', 'effectiveness and cost-effectiveness']","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0557829', 'cui_str': 'Healthcare services'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0243024', 'cui_str': 'Patient-Centered Care'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.155179,"Secondary outcomes include patient management and symptoms, use of healthcare services, and the costs of implementing this intervention will also be estimated.","[{'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Johnson', 'Affiliation': '2-040 Li Ka Shing Centre for Health Research Innovation, School of Public Health, University of Alberta, Edmonton, AB, T6G 2E1, Canada. jeff.johnson@ualberta.ca.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Al Sayah', 'Affiliation': '2-040 Li Ka Shing Centre for Health Research Innovation, School of Public Health, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Buzinski', 'Affiliation': 'Patient Partner, Medicine Hat, Alberta, Canada.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Corradetti', 'Affiliation': 'Patient Partner, Medicine Hat, Alberta, Canada.'}, {'ForeName': 'Sara N', 'Initials': 'SN', 'LastName': 'Davison', 'Affiliation': '11-113L Clinical Sciences Building, Division of Nephrology and Immunology, Department of Medicine, University of Alberta, Edmonton, AB, T6G 2G3, Canada.'}, {'ForeName': 'Meghan J', 'Initials': 'MJ', 'LastName': 'Elliott', 'Affiliation': 'Foothills Medical Centre, 1403 - 29th Street NW, Calgary, AB, T2N 2T9, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Klarenbach', 'Affiliation': '11-107 Clinical Sciences Building, Division of Nephrology and Immunology, Department of Medicine, University of Alberta, Edmonton, AB, T6G 2G3, Canada.'}, {'ForeName': 'Braden', 'Initials': 'B', 'LastName': 'Manns', 'Affiliation': 'Foothills Medical Centre, 1403 - 29th Street NW, Calgary, AB, T2N 2T9, Canada.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Schick-Makaroff', 'Affiliation': '5-295 Edmonton Clinic Health Academy, Faculty of Nursing, University of Alberta, Edmonton, AB, T6G 1C9, Canada.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Short', 'Affiliation': '2-040 Li Ka Shing Centre for Health Research Innovation, School of Public Health, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Chandra', 'Initials': 'C', 'LastName': 'Thomas', 'Affiliation': 'Foothills Medical Centre, 1403 - 29th Street NW, Calgary, AB, T2N 2T9, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Walsh', 'Affiliation': ""Division of Nephrology, Department of Medicine, McMaster University, Marion Wing, Level 3, St. Joseph's Healthcare, 50 Charlton Ave. E, Hamilton, ON, L8N 4A6, Canada.""}]",BMC health services research,['10.1186/s12913-020-05557-z']
2013,32778123,Efficacy of Glyceryl trinitrate (GTN) to facilitate the rewarming process during cardiopulmonary bypass.,"BACKGROUND


Does Glyceryl trinitrate (GTN) administered during rewarming on cardiopulmonary bypass (CPB) impact: time to completion of rewarming prior to separation from CPB circuit, early post-op patient peripheral - core temperature gradient, time to maintenance of normothermia (core temperature > 36.5 °C) for minimum of 2 h in the initial post-op period, and plasma lactate concentrations initially post-CPB.
METHODS


Single centre prospective randomized trial conducted in the Mater Misericordiae University teaching hospital in Dublin Ireland.
TRIAL REGISTRATION


ISRCTN registry, ISRCTN10480871 , registered 16th of August 2017. 82 patients enrolled. Patients randomised to low dose GTN infusion (0.01 mcg/kg/min) or higher dose GTN infusion (0.5 mcg/kg/min) during rewarming on CPB.
MEASUREMENTS AND MAIN RESULTS


There was no significant difference between the treatment arms for the total time to being rewarmed, U = 759.0, p = 0.84. There were also no differences between the treatment arms for the time to achieve core temperature greater than 36.5 after two hours, U = 714.0, p = 0.52, the time to achieve plateau core skin temperature, U = 688.0, p = 0.37, and the post-intervention protamine lactate, U = 721.0, p = 0.56.
CONCLUSIONS


Higher dose GTN infusion during rewarming on CPB does not improve peripheral-core temperature gradient post operatively and has no effect on post-operative lactate concentrations.",2020,Higher dose GTN infusion during rewarming on CPB does not improve peripheral-core temperature gradient post operatively and has no effect on post-operative lactate concentrations.,"['82 patients enrolled', 'Mater Misericordiae University teaching hospital in Dublin Ireland']","['GTN infusion', 'Glyceryl trinitrate (GTN']","['total time to being rewarmed', 'time to achieve core temperature greater']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0454777', 'cui_str': 'Dublin'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}]","[{'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0205393', 'cui_str': 'Most'}]",82.0,0.0896275,Higher dose GTN infusion during rewarming on CPB does not improve peripheral-core temperature gradient post operatively and has no effect on post-operative lactate concentrations.,"[{'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Mullane', 'Affiliation': 'Mater Misercordiae University Hospital Division of Anesthesia, 7 Eccles Street, Dublin, Ireland. mullanedp@gmail.com.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lenihan', 'Affiliation': 'Mater Misercordiae University Hospital Division of Anesthesia, 7 Eccles Street, Dublin, Ireland.'}, {'ForeName': 'Ciara', 'Initials': 'C', 'LastName': 'Hanley', 'Affiliation': 'Mater Misercordiae University Hospital Division of Anesthesia, 7 Eccles Street, Dublin, Ireland.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Wall', 'Affiliation': 'Mater Misercordiae University Hospital Division of Anesthesia, 7 Eccles Street, Dublin, Ireland.'}, {'ForeName': 'Irmina', 'Initials': 'I', 'LastName': 'Bukowska', 'Affiliation': 'Mater Misercordiae University Hospital Division of Anesthesia, 7 Eccles Street, Dublin, Ireland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Griffin', 'Affiliation': 'Mater Misercordiae University Hospital Division of Anesthesia, 7 Eccles Street, Dublin, Ireland.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Flood', 'Affiliation': 'Mater Misercordiae University Hospital Division of Anesthesia, 7 Eccles Street, Dublin, Ireland.'}]",Journal of cardiothoracic surgery,['10.1186/s13019-020-01258-0']
2014,32778139,Correction to: Investigating the non-specific effects of BCG vaccination on the innate immune system in Ugandan neonates: study protocol for a randomised controlled trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['Ugandan neonates'],['BCG vaccination'],[],"[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]","[{'cui': 'C0199804', 'cui_str': 'BCG vaccination'}]",[],,0.0719374,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Prentice', 'Affiliation': 'Wellcome Trust - Bloomsbury Centre for Global Health Research, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. Sarah.prentice@lshtm.ac.uk.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Webb', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Hazel M', 'Initials': 'HM', 'LastName': 'Dockrell', 'Affiliation': 'Wellcome Trust - Bloomsbury Centre for Global Health Research, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Pontiano', 'Initials': 'P', 'LastName': 'Kaleebu', 'Affiliation': 'MRC/Uganda Virus Research Institute on AIDS, Plot 51-59, Nakiwogo Road, PO Box 49, Entebbe, Uganda.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Elliott', 'Affiliation': 'Wellcome Trust - Bloomsbury Centre for Global Health Research, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Cose', 'Affiliation': 'Department of Infection and Immunology, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}]",Trials,['10.1186/s13063-020-04594-7']
2015,32778146,Effect of dexmedetomidine on inflammation in patients with sepsis requiring mechanical ventilation: a sub-analysis of a multicenter randomized clinical trial.,"BACKGROUND


Administration of dexmedetomidine has been reported to improve inflammatory response in animals. We explored the effects of administering dexmedetomidine on the levels of C-reactive protein (CRP) and procalcitonin, and thus on inflammation, in patients with sepsis enrolled in a randomized clinical trial.
METHODS


The DESIRE trial was a multicenter randomized clinical trial in which adult patients with sepsis were sedated with (DEX group) or without (non-DEX group) dexmedetomidine while on mechanical ventilators. As a prespecified sub-analysis, we compared CRP and procalcitonin levels during the first 14 days of treatment between the two groups. The 14-day mortality rate, albumin level, and the number of patients with disseminated intravascular coagulation (DIC) were also assessed. We used generalized linear models to estimate the differences in these outcomes between groups. We also used the Kaplan-Meier method to estimate the 14-day mortality rate and the log-rank test to assess between-group differences.
RESULTS


Our study comprised 201 patients: 100 in the DEX group and 101 in the non-DEX group. CRP and procalcitonin levels were lower in the DEX vs. non-DEX group during the 14-day treatment period [CRP-range, 5.6-20.3 vs. 8.3-21.1 mg/dL (P = 0.03); procalcitonin-range, 1.2-37.4 vs. 1.7-52.9 ng/mL (P = 0.04)]. Albumin levels were higher in the DEX group (range, 2.3-2.6 g/dL) than in the non-DEX group (range, 2.1-2.7 g/dL; P = 0.01). The percentage of patients with DIC did not significantly differ between the groups (range, 21-59% and 17-56% for the DEX and non-DEX groups, respectively; P = 0.49). The 14-day mortality rates in the DEX and non-DEX groups were 13 and 21%, respectively (P = 0.16).
CONCLUSION


Sedation using dexmedetomidine reduced inflammation in patients with sepsis requiring mechanical ventilation.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT01760967 . Registered on 4 January 2013.",2020,"CRP and procalcitonin levels were lower in the DEX vs. non-DEX group during the 14-day treatment period [CRP-range, 5.6-20.3 vs. 8.3-21.1 mg/dL (P = 0.03); procalcitonin-range, 1.2-37.4 vs. 1.7-52.9 ","['patients with sepsis enrolled in a randomized clinical trial', '201 patients: 100 in the DEX group and 101 in the non-DEX group', 'adult patients with sepsis were', 'patients with sepsis requiring mechanical ventilation']","['DEX vs. non-DEX', 'DEX', 'DEX and non-DEX', 'dexmedetomidine', 'sedated with (DEX group) or without (non-DEX group) dexmedetomidine']","['Albumin levels', 'percentage of patients with DIC', '14-day mortality rate, albumin level, and the number of patients with disseminated intravascular coagulation (DIC', 'CRP and procalcitonin levels', '14-day mortality rate', '14-day mortality rates', 'inflammatory response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0201838', 'cui_str': 'Albumin measurement'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012739', 'cui_str': 'Disseminated intravascular coagulation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1535922', 'cui_str': 'Procalcitonin'}]",,0.136848,"CRP and procalcitonin levels were lower in the DEX vs. non-DEX group during the 14-day treatment period [CRP-range, 5.6-20.3 vs. 8.3-21.1 mg/dL (P = 0.03); procalcitonin-range, 1.2-37.4 vs. 1.7-52.9 ","[{'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Ohta', 'Affiliation': 'Education and Training Center for Students and Professionals in Healthcare, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Kyohei', 'Initials': 'K', 'LastName': 'Miyamoto', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Kawazoe', 'Affiliation': 'Division of Emergency and Critical Care Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Yamamura', 'Affiliation': 'Osaka Prefectural Nakakawachi Emergency and Critical Care Center, Higashiosaka, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan. morimoto@kuhp.kyoto-u.ac.jp.'}]","Critical care (London, England)",['10.1186/s13054-020-03207-8']
2016,32778150,Postprandial effects of a meal low in sulfur amino acids and high in polyunsaturated fatty acids compared to a meal high in sulfur amino acids and saturated fatty acids on stearoyl CoA-desaturase indices and plasma sulfur amino acids: a pilot study.,"OBJECTIVE


The sulfur amino acid (SAA) cysteine is positively related, whereas polyunsaturated fatty acids (PUFAs) are inversely related to activity of the lipogenic enzyme stearoyl-CoA desaturase (SCD). High SCD activity promotes obesity in animals, and plasma activity indices positively associates with fat mass in humans. SCD may thus be a target for dietary intervention with SAA restriction and PUFA enrichment with unknown potential benefits for body composition. We randomized ten healthy individuals to a meal restricted in SAAs and enriched with PUFAs (Cys/Met low  + PUFA) (n = 5) or a meal enriched in SAA and saturated fatty acids (Cys/Met high  + SFA) (n = 5). We measured plasma SCD activity indices (SCD16 and SCD18) and SAAs response hourly from baseline and up to 4 h postprandial.
RESULTS


SCD16 was unchanged whereas SCD18 tended to increase in the Cys/Met low  + PUFA compared to the Cys/Met high  + SFA group (p time*group interaction  = 0.08). Plasma concentrations of total cysteine fractions including free and reduced cysteine decreased in the Cys/Met low  + PUFA compared to the Cys/Met high  + SFA group (both p time*group interaction  < 0.001). In conclusion, a meal low in SAA but high in PUFAs reduced plasma cysteine fractions but not SCD activity indices. This pilot study can be useful for the design and diet composition of future dietary interventions that targets SCD and SAA. Trial registration ClinicalTrials.gov: NCT02647970, registration date: 6 January 2016.",2020,Plasma concentrations of total cysteine fractions including free and reduced cysteine decreased in the Cys/Met low  + PUFA compared to the Cys/Met high  + SFA group (both p time*group interaction  < 0.001).,['healthy individuals to a meal restricted in SAAs and enriched with PUFAs (Cys/Met low \u2009+\u2009PUFA) (n\u2009=\u20095) or a'],"['SCD', 'sulfur amino acid (SAA) cysteine', 'meal enriched in SAA and saturated fatty acids (Cys/Met high \u2009+\u2009SFA']","['Postprandial effects', 'Plasma concentrations of total cysteine fractions including free and reduced cysteine', 'SCD18', 'plasma SCD activity indices (SCD16 and SCD18) and SAAs response hourly']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0002723', 'cui_str': 'Serum amyloid A protein'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}]","[{'cui': 'C0038233', 'cui_str': 'Acyl-CoA desaturase'}, {'cui': 'C0002527', 'cui_str': 'Sulfur-bearing amino acid'}, {'cui': 'C0010654', 'cui_str': 'Cysteine'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010654', 'cui_str': 'Cysteine'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0038233', 'cui_str': 'Acyl-CoA desaturase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0002723', 'cui_str': 'Serum amyloid A protein'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}]",10.0,0.0315221,Plasma concentrations of total cysteine fractions including free and reduced cysteine decreased in the Cys/Met low  + PUFA compared to the Cys/Met high  + SFA group (both p time*group interaction  < 0.001).,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Olsen', 'Affiliation': 'Department of Nutrition, Institute of Medical Biosciences, University of Oslo, 0372, Oslo, Norway. thomas.olsen@medisin.uio.no.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Turner', 'Affiliation': 'Department of Pharmacology, University of Oxford, Oxford, OX1 3QT, UK.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Øvrebø', 'Affiliation': 'Department of Nutrition, Institute of Medical Biosciences, University of Oslo, 0372, Oslo, Norway.'}, {'ForeName': 'Nasser E', 'Initials': 'NE', 'LastName': 'Bastani', 'Affiliation': 'Department of Nutrition, Institute of Medical Biosciences, University of Oslo, 0372, Oslo, Norway.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Refsum', 'Affiliation': 'Department of Nutrition, Institute of Medical Biosciences, University of Oslo, 0372, Oslo, Norway.'}, {'ForeName': 'Kathrine J', 'Initials': 'KJ', 'LastName': 'Vinknes', 'Affiliation': 'Department of Nutrition, Institute of Medical Biosciences, University of Oslo, 0372, Oslo, Norway.'}]",BMC research notes,['10.1186/s13104-020-05222-y']
2017,32778158,"Using electroacupuncture to recover muscle strength in patients with knee osteoarthritis after total knee arthroplasty: a study protocol for a double-blinded, randomized, and placebo-controlled trial.","BACKGROUND


Total knee arthroplasty (TKA) is a gold standard for patients with terminal term gonarthrosis for reducing pain, correcting deformities, and regaining stability. However, post-TKA muscle strength recovery is often difficult. Although electroacupuncture (EA) enhances lower extremity muscle strength of the lower extremity, there is limited evidence regarding its effect on lower extremity muscle strength in post-TKA patients. Consequently, this trial intends to evaluate the efficacy of post-TKA EA on the recovery of lower extremity muscle strength, specifically, during the early post-TKA period.
METHODS/DESIGN


This is a double-blinded, randomized, and controlled trial. It will be conducted between August 2020 and December 2020. Ninety-four participants with KOA who have undergone unilateral TKA will be randomized into a treatment (EA) group and a control (sham EA) group. The former and latter groups will receive EA and sham EA, respectively, at ST37, ST36, SP10, and SP9 acupoints. The participants will undergo ten treatment sessions over 2 weeks (5 sessions per week). The primary outcomes will include changes in muscle strength and the Hospital for Special Surgery score at the second week from baseline (pre-op 1 day or POD 3). The secondary outcomes will include a 4-m walk test, numerical rating scale score, the Hamilton Anxiety Scale score, and additional analgesia use. Additional outcomes will include the incidence of analgesia-related side effects and the participant satisfaction rate. Participant blinding will also be assessed where they will be asked to guess whether they received EA after the latest intervention. Adverse EA events will be documented and assessed throughout the trial.
DISCUSSION


EA is helpful for post-TKA recovery and enhancement of lower limb muscle strength.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR1900027806 . Registered on 29 November 2019.",2020,"The former and latter groups will receive EA and sham EA, respectively, at ST37, ST36, SP10, and SP9 acupoints.","['patients with knee osteoarthritis after total knee arthroplasty', 'Ninety-four participants with KOA who have undergone unilateral TKA', 'patients with terminal term gonarthrosis']","['electroacupuncture (EA', 'electroacupuncture', 'Total knee arthroplasty (TKA', 'control (sham EA', 'post-TKA EA', 'placebo']","['extremity muscle strength', '4-m walk test, numerical rating scale score, the Hamilton Anxiety Scale score, and additional analgesia use', 'Adverse EA events', 'incidence of analgesia-related side effects and the participant satisfaction rate', 'changes in muscle strength and the Hospital for Special Surgery score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",94.0,0.461604,"The former and latter groups will receive EA and sham EA, respectively, at ST37, ST36, SP10, and SP9 acupoints.","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Joint Orthopaedics, Guanghua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, 200050, China.'}, {'ForeName': 'Bingxin', 'Initials': 'B', 'LastName': 'Kang', 'Affiliation': 'Department of Joint Orthopaedics, Guanghua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, 200050, China.'}, {'ForeName': 'Yulin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Joint Orthopaedics, Guanghua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, 200050, China.'}, {'ForeName': 'Songtao', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Department of Joint Orthopaedics, Guanghua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, 200050, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Zhong', 'Affiliation': 'Department of Joint Orthopaedics, Guanghua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, 200050, China.'}, {'ForeName': 'Chenxin', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': 'Department of Joint Orthopaedics, Guanghua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, 200050, China.'}, {'ForeName': 'Xirui', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Joint Orthopaedics, Guanghua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, 200050, China.'}, {'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Department of Joint Orthopaedics, Guanghua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, 200050, China.'}, {'ForeName': 'Guowei', 'Initials': 'G', 'LastName': 'Qiu', 'Affiliation': 'Department of Joint Orthopaedics, Guanghua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, 200050, China.'}, {'ForeName': 'Lianbo', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Joint Orthopaedics, Guanghua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, 200050, China. xiao_lianbo@163.com.'}]",Trials,['10.1186/s13063-020-04601-x']
2018,32778159,Recruitment and retention of mothers of preschoolers and school-aged children in a social media-delivered healthy eating intervention: lessons learned from a randomized controlled trial.,"BACKGROUND


Social media represent cost-effective platforms to advance the dissemination and uptake of health research to improve population health. However, there is limited evidence available to support researchers overcome methodological challenges related to recruitment and retention of participants in studies using social media for delivering behavior change interventions. This study aims to describe the recruitment and the retention strategies used in a randomized controlled trial (RCT) that evaluated a blog-delivered healthy eating intervention among mothers of preschoolers and school-aged children.
METHODS


Eighty-four adult mothers of children aged between two and 12 years old living in Quebec City, Quebec, Canada, were recruited between October 2015 and February 2017 using traditional methods (e.g. institutional email lists, flyers, newspapers, and word of mouth) and Facebook advertisements. Retention rates were calculated at the end of the 6-month intervention and at a 12-month follow-up assessment. Sociodemographic characteristics, Internet use behaviors and retention rates of mothers recruited through traditional methods and Facebook were compared using Wilcoxon-Mann-Whitney tests and Fisher exact tests.
RESULTS


Of the 196 mothers who responded to the recruitment call, 87 (44.4%) were eligible and 84 (42.9%) were randomized to the trial, representing a recruitment success of 76.4% (84/110) from the planned sample size target. Among those, a minority (3.6%) were recruited using Facebook. Those mothers presented similar sociodemographic characteristics to those recruited using traditional methods. Retention rates were 73.8% and 66.7% at 6 and 12 months, respectively, with similar rates between mothers recruited using Facebook and traditional methods. Various challenges associated with population retention were highlighted with lack of time being mothers' main reason for withdrawing from the study.
CONCLUSIONS


The methodological challenges experienced during the conduct of the blog-delivered healthy eating intervention allowed to draw upon several lessons regarding the recruitment process and the retention of mothers of preschoolers and school-aged children to inform future social media-delivered research. Recommendations for future research include exploring mothers' perceptions and preferences to tailor social media recruitment, ensure that interventions are delivered to them using social media platforms that are already integrated into their routine, and are providing remote outcome assessments to increase participant retention.
TRIAL REGISTRATION


Clinical Trial Protocol NCT03156803 . Registered on 17 May 2017, retrospectively registered.",2020,"Retention rates were 73.8% and 66.7% at 6 and 12 months, respectively, with similar rates between mothers recruited using Facebook and traditional methods.","['mothers of preschoolers and school-aged children', 'mothers of preschoolers and school-aged children in a social media-delivered healthy eating intervention', 'Eighty-four adult mothers of children aged between two and 12\u2009years old living in Quebec City, Quebec, Canada, were recruited between October 2015 and February 2017 using traditional methods (e.g. institutional email lists, flyers, newspapers, and word of mouth) and Facebook advertisements', '196 mothers who responded to the recruitment call, 87 (44.4%) were eligible and 84 (42.9']",['blog-delivered healthy eating intervention'],"['Retention rates', 'Sociodemographic characteristics, Internet use behaviors and retention rates']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0027989', 'cui_str': 'Newspapers'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C4517773', 'cui_str': '42.9'}]","[{'cui': 'C2718045', 'cui_str': 'Blogs as Topic'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",84.0,0.154307,"Retention rates were 73.8% and 66.7% at 6 and 12 months, respectively, with similar rates between mothers recruited using Facebook and traditional methods.","[{'ForeName': 'Audrée-Anne', 'Initials': 'AA', 'LastName': 'Dumas', 'Affiliation': 'Institute of Nutrition and Functional Foods, School of Nutrition, Faculty of Agriculture and Food Sciences, Université Laval, Pavillon des services, office 2729-P, 2440 Hochelaga Boulevard, Quebec City, Quebec, G1V 0A6, Canada.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Lemieux', 'Affiliation': 'Institute of Nutrition and Functional Foods, School of Nutrition, Faculty of Agriculture and Food Sciences, Université Laval, Pavillon des services, office 2729-P, 2440 Hochelaga Boulevard, Quebec City, Quebec, G1V 0A6, Canada.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Lapointe', 'Affiliation': 'Institute of Nutrition and Functional Foods, School of Nutrition, Faculty of Agriculture and Food Sciences, Université Laval, Pavillon des services, office 2729-P, 2440 Hochelaga Boulevard, Quebec City, Quebec, G1V 0A6, Canada.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Provencher', 'Affiliation': 'Institute of Nutrition and Functional Foods, School of Nutrition, Faculty of Agriculture and Food Sciences, Université Laval, Pavillon des services, office 2729-P, 2440 Hochelaga Boulevard, Quebec City, Quebec, G1V 0A6, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Robitaille', 'Affiliation': 'Institute of Nutrition and Functional Foods, School of Nutrition, Faculty of Agriculture and Food Sciences, Université Laval, Pavillon des services, office 2729-P, 2440 Hochelaga Boulevard, Quebec City, Quebec, G1V 0A6, Canada.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Desroches', 'Affiliation': 'Institute of Nutrition and Functional Foods, School of Nutrition, Faculty of Agriculture and Food Sciences, Université Laval, Pavillon des services, office 2729-P, 2440 Hochelaga Boulevard, Quebec City, Quebec, G1V 0A6, Canada. sophie.desroches@fsaa.ulaval.ca.'}]",Trials,['10.1186/s13063-020-04628-0']
2019,32778175,Effect of D-ribose supplementation on delayed onset muscle soreness induced by plyometric exercise in college students.,"OBJECTIVE


Previous investigations suggest that appropriate nutritional interventions may reduce delayed onset muscle soreness (DOMS). This study examined the effect of D-ribose supplementation on DOMS induced by plyometric exercise.
METHODS


For the purpose of inducing DOMS, 21 untrained male college students performed a lower-limb plyometric exercise session that involved 7 sets of 20 consecutive frog hops with 90-s of rest between each set. Muscle soreness was measured with a visual analogue scale 1-h before, 24-h after, and 48-h after exercise. Subjects were then randomly placed into the D-ribose group (DRIB, n = 11) and the placebo group (PLAC, n = 10) to assure equivalent BMI and muscle soreness. After a 14-d washout/recovery period, subjects performed the same exercise session, with DRIB ingesting a 200 ml solution containing 15 g D-ribose 1-h before, 1-h, 12-h, 24-h, and 36-h after exercise, and PLAC ingesting a calorically equivalent placebo of the same volume and taste containing sorbitol and β-cyclodextrin. Muscle soreness and isokinetic muscle strength were measured, and venous blood was assessed for markers of muscle damage and oxidative stress 1-h before, 24-h and 48-h after exercise.
RESULTS


In DRIB, muscle soreness after 24-h and 48-h in the second exercise session were significantly lower (p < 0.01) than was experienced in the first exercise session. In the second exercise, blood-related markers of muscle soreness, including creatine kinase, lactate dehydrogenase (LDH), myoglobin and malondialdehyde (MDA) in DRIB after 24-h were lower in DRIB after 24-h than in PLAC (MDA, p < 0.05; rest outcomes, p < 0.01). In addition, LDH and MDA in DRIB were significantly lower (p < 0.01) after 24-h in DRIB than in PLAC. No difference was found in isokinetic muscle strength and oxidative stress markers, including superoxide dismutase and total antioxidant capacity, between DRIB and PLAC after 24-h and 48-h.
CONCLUSION


D-ribose supplementation reduces muscle soreness, improves recovery of muscle damage, and inhibits the formation of lipid peroxides. Young adult males performing plyometric exercise are likely to realize a DOMS reduction through consumption of D-ribose in 15 g/doses both before (1-h) and after (1-h, 12-h, 24-h, 36-h) exercise. These results suggest that appropriately timed consumption of D-ribose may induce a similar alleviation of exercise-induced DOMS in the general public.",2020,"No difference was found in isokinetic muscle strength and oxidative stress markers, including superoxide dismutase and total antioxidant capacity, between DRIB and PLAC after 24-h and 48-h.
","['Young adult males performing', '21 untrained male college students', 'college students']","['PLAC ingesting a calorically equivalent placebo of the same volume and taste containing sorbitol and β-cyclodextrin', 'D-ribose supplementation', 'placebo group (PLAC, n\u2009=\u200910) to assure equivalent BMI and muscle soreness', 'limb plyometric exercise session', 'plyometric exercise']","['Muscle soreness', 'DRIB, muscle soreness', 'delayed onset muscle soreness', 'isokinetic muscle strength and oxidative stress markers, including superoxide dismutase and total antioxidant capacity, between DRIB and PLAC', 'oxidative stress', 'blood-related markers of muscle soreness, including creatine kinase, lactate dehydrogenase (LDH), myoglobin and malondialdehyde (MDA) in DRIB', 'recovery of muscle damage, and inhibits the formation of lipid peroxides', 'muscle soreness', 'delayed onset muscle soreness (DOMS', 'Muscle soreness and isokinetic muscle strength', 'LDH and MDA in DRIB']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0048838', 'cui_str': ""5'-palmitoyl cytarabine""}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0037688', 'cui_str': 'Sorbitol'}, {'cui': 'C0010558', 'cui_str': 'Cyclodextrins'}, {'cui': 'C0035549', 'cui_str': 'Ribose'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}]","[{'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0048838', 'cui_str': ""5'-palmitoyl cytarabine""}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0027078', 'cui_str': 'Myoglobin'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0023776', 'cui_str': 'Fatty Acid Hydroperoxides'}]",21.0,0.0746045,"No difference was found in isokinetic muscle strength and oxidative stress markers, including superoxide dismutase and total antioxidant capacity, between DRIB and PLAC after 24-h and 48-h.
","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cao', 'Affiliation': 'Department of Exercise Biochemistry, Exercise Science School, Beijing Sport University, No. 48 Xinxi Road, Haidian District, Beijing, China.'}, {'ForeName': 'Junqiang', 'Initials': 'J', 'LastName': 'Qiu', 'Affiliation': 'Department of Exercise Biochemistry, Exercise Science School, Beijing Sport University, No. 48 Xinxi Road, Haidian District, Beijing, China. qiujq001@sina.com.'}, {'ForeName': 'Tianwei', 'Initials': 'T', 'LastName': 'Cai', 'Affiliation': 'Department of Exercise Biochemistry, Exercise Science School, Beijing Sport University, No. 48 Xinxi Road, Haidian District, Beijing, China.'}, {'ForeName': 'Longyan', 'Initials': 'L', 'LastName': 'Yi', 'Affiliation': 'Department of Exercise Biochemistry, Exercise Science School, Beijing Sport University, No. 48 Xinxi Road, Haidian District, Beijing, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Benardot', 'Affiliation': 'Department of Nutrition, Georgia State University, Atlanta, GA, USA.'}, {'ForeName': 'Menghui', 'Initials': 'M', 'LastName': 'Zou', 'Affiliation': 'China Athletics College, Beijing Sport University, Beijing, BJ, China.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00371-8']
2020,32778372,The use of web-based classroom gaming to facilitate cognitive integration in undergraduate nursing students: A mixed methods study.,"BACKGROUND


Classroom gaming is a promising teaching and learning strategy that has been shown to facilitate engagement and meaningful learning. This paper aimed to determine whether classroom gaming using a web-based platform can facilitate cognitive integration to prepare undergraduate nursing students for clinical practice.
METHODS


A sequential explanatory design mixed-methods study was conducted. A randomized controlled design study, with knowledge and simulation performance as outcome measures, was conducted. This was followed by focus group discussions.
RESULTS


There is a significant improvement in pre- and post-test scores (t=-4.47). However, there was no statistically significant difference between the pre-test scores (t=1.50) of the intervention group and those of the control group. Similarly, the post-test scores of these groups were also not significantly different statistically (t=-0.15). Skills assessment results also showed no difference between the scores of those in the intervention group and of those in the control group (t=1.19). Themes generated were: useful for revision, linking of concepts, and gaming as a challenge.
CONCLUSION


The use of classroom gaming to facilitate integration of knowledge based on knowledge and performance tests did not yield positive results. However, focus group interviews demonstrated that the study's participants perceived strategy to be helpful in their learning.",2020,Skills assessment results also showed no difference between the scores of those in the intervention group and of those in the control group (t=1.19).,"['undergraduate nursing students for clinical practice', 'undergraduate nursing students']","['classroom gaming using a web-based platform', 'web-based classroom gaming', 'classroom gaming']",[],"[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],,0.0699847,Skills assessment results also showed no difference between the scores of those in the intervention group and of those in the control group (t=1.19).,"[{'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Ignacio', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: nurimjj@nus.edu.sg.'}, {'ForeName': 'Hui-Chen', 'Initials': 'HC', 'LastName': 'Chen', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: nurch@nus.edu.sg.'}]",Nurse education in practice,['10.1016/j.nepr.2020.102820']
2021,32778391,The effect of Reiki and guided imagery intervention on pain and fatigue in oncology patients: A non-randomized controlled study.,"This study was conducted to investigate the effects of Reiki and guided imagery on pain and fatigue in oncology patients. This quasi-experimental study with a pretest and posttest design was conducted with 180 oncology patients at the oncology clinic of Dicle University Hospital in Turkey, between July 2017 and February 2018. The patients were divided into three groups: Reiki, guided imagery and control, with 60 patients in each group. The Reiki and guided imagery group patients underwent their respective interventions for three consecutive days separately (25-30 min; mean: 15.53 min). The interventions of Reiki and guided imagery reduced pain and fatigue in the oncology patients. It is recommended that oncology nurses use Reiki and guided imagery in patient care.",2020,The interventions of Reiki and guided imagery reduced pain and fatigue in the oncology patients.,"['180 oncology patients at the oncology clinic of Dicle University Hospital in Turkey, between July 2017 and February 2018', 'oncology patients']","['Reiki and guided imagery intervention', 'Reiki and guided imagery']",['pain and fatigue'],"[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]","[{'cui': 'C0751715', 'cui_str': 'Reiki'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",180.0,0.0172522,The interventions of Reiki and guided imagery reduced pain and fatigue in the oncology patients.,"[{'ForeName': 'Zeliha', 'Initials': 'Z', 'LastName': 'Buyukbayram', 'Affiliation': 'Nursing Department, Faculty of Health Sciences, Siirt University, Siirt, Turkey.'}, {'ForeName': 'Seyhan', 'Initials': 'S', 'LastName': 'Citlik Saritas', 'Affiliation': 'Medical Nursing Department, Faculty of Nursing, Inonu University, Malatya, Turkey. Electronic address: seyhancitlik@hotmail.com.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2020.07.009']
2022,32778416,"Letter to the Editor on ""A Randomized Control Trial Comparing a Medial Stabilized Total Prosthesis to a Cruciate Retaining and Posterior Stabilized Design: A Report of the Clinical and Functional Outcome Following Total Knee Replacement"".",,2020,,[],"['Medial Stabilized Total Prosthesis to a Cruciate Retaining and Posterior Stabilized Design', 'Total Knee Replacement']",[],[],"[{'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]",[],,0.0283064,,"[{'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Kulshrestha', 'Affiliation': 'Department of Orthopaedics and Joint Replacement Surgery, Command Hospital Air Force, Bengaluru, India.'}, {'ForeName': 'Munish', 'Initials': 'M', 'LastName': 'Sood', 'Affiliation': 'Department of Orthopaedics, Command Hospital, Chandimandir, India.'}, {'ForeName': 'Santhosh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Department of Orthopaedics and Joint Replacement Surgery, Command Hospital Air Force, Bengaluru, India.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.07.040']
2023,32778417,"Letter to the Editor: ""A Randomized Controlled Trial Comparing a Medial Stabilized Total Knee Prosthesis to a Cruciate Retaining and Posterior Stabilized Design: A Report of the Clinical and Functional Outcomes Following Total Knee Replacement"".",,2020,,[],"['Medial Stabilized Total Knee Prosthesis to a Cruciate Retaining and Posterior Stabilized Design', 'Total Knee Replacement']",[],[],"[{'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0182477', 'cui_str': 'Total knee joint prosthesis'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]",[],,0.0552925,,"[{'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Dowsey', 'Affiliation': ""Department of Surgery, The University of Melbourne, St Vincent's Hospital, Melbourne, Victoria, Australia; Department of Orthopaedics, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Tim D', 'Initials': 'TD', 'LastName': 'Spelman', 'Affiliation': ""Department of Surgery, The University of Melbourne, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Choong', 'Affiliation': ""Department of Surgery, The University of Melbourne, St Vincent's Hospital, Melbourne, Victoria, Australia; Department of Orthopaedics, St Vincent's Hospital, Melbourne, Victoria, Australia.""}]",The Journal of arthroplasty,['10.1016/j.arth.2020.07.042']
2024,32778434,Multi-cultural perspectives on group singing among diverse older adults.,"Group choir singing has been shown to have health benefits for older adults. However, because most studies have included predominantly white participants, it is unknown whether findings generalize to older adults from more diverse backgrounds. This multi-site qualitative study assessed perceived benefits of group singing for socioeconomically and racially/ethnically diverse older adults. We interviewed 31 choir participants, 6 music professionals and 6 administrators involved in a large, cluster-randomized trial. We used content analysis to identify themes. Psychosocial engagement was most commonly reported, with six components: emotional well-being, self-esteem, self-confidence, social connection and support, decreased loneliness, and cultural identity and multi-cultural appreciation. A few reported cognitive and physical benefits. They also suggest that group singing among ethnically diverse older adults can have multiple psychosocial benefits and enhance a sense of cultural identity and appreciation of other cultures. These findings can help in selecting structured outcome measures for choir interventions.",2020,"Psychosocial engagement was most commonly reported, with six components: emotional well-being, self-esteem, self-confidence, social connection and support, decreased loneliness, and cultural identity and multi-cultural appreciation.","['older adults', 'diverse older adults', '31 choir participants, 6 music professionals and 6 administrators involved in a large, cluster-randomized trial', 'ethnically diverse older adults', 'socioeconomically and racially/ethnically diverse older adults']",[],"['emotional well-being, self-esteem, self-confidence, social connection and support, decreased loneliness, and cultural identity and multi-cultural appreciation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0085751', 'cui_str': 'Administrators'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0424215', 'cui_str': 'Sense of identity'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]",31.0,0.0463533,"Psychosocial engagement was most commonly reported, with six components: emotional well-being, self-esteem, self-confidence, social connection and support, decreased loneliness, and cultural identity and multi-cultural appreciation.","[{'ForeName': 'Theresa A', 'Initials': 'TA', 'LastName': 'Allison', 'Affiliation': 'Division of Geriatrics, Department of Medicine and Department of Family & Community Medicine, University of California, 4150 Clement Street, Box 181-G, San Francisco, CA 94121, United States. Electronic address: theresa.allison@ucsf.edu.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Nápoles', 'Affiliation': 'Division of Intramural Research, National Institute on Minority Health and Health Disparities, National Institutes of Health, 9000 Rockville Pike, Building 3, Floor 5, Room E08, Bethesda, MD 20892, United States.'}, {'ForeName': 'Julene K', 'Initials': 'JK', 'LastName': 'Johnson', 'Affiliation': 'Institute for Health & Aging, School of Nursing, University of California San Francisco, 3333 California Street, Suite 340, San Francisco, CA 94118, United States.'}, {'ForeName': 'Anita L', 'Initials': 'AL', 'LastName': 'Stewart', 'Affiliation': 'Institute for Health & Aging, School of Nursing, University of California San Francisco, 3333 California Street, Suite 340, San Francisco, CA 94118, United States.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Rodriguez-Salazar', 'Affiliation': 'San Francisco Community Music Center, 544 Capp Street, San Francisco, CA 94110, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Peringer', 'Affiliation': 'San Francisco Community Music Center, 544 Capp Street, San Francisco, CA 94110, United States.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Sherman', 'Affiliation': 'San Francisco Community Music Center, 544 Capp Street, San Francisco, CA 94110, United States.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ortez-Alfaro', 'Affiliation': 'Institute for Health & Aging, School of Nursing, University of California San Francisco, 3333 California Street, Suite 340, San Francisco, CA 94118, United States.'}, {'ForeName': 'Ofelia', 'Initials': 'O', 'LastName': 'Villero', 'Affiliation': 'Institute for Health & Aging, School of Nursing, University of California San Francisco, 3333 California Street, Suite 340, San Francisco, CA 94118, United States.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Portacolone', 'Affiliation': 'Institute for Health & Aging, School of Nursing, University of California San Francisco, 3333 California Street, Suite 340, San Francisco, CA 94118, United States.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2020.07.011']
2025,32778471,Phosphatemic Index Is a Novel Evaluation Tool for Dietary Phosphorus Load: A Whole-Foods Approach.,"OBJECTIVE


Dietary phosphorus (P) restriction is crucial to treat hyperphosphatemia and reduce cardiovascular disease risk and mortality in patients with chronic kidney disease (CKD) and the wider population. Various methods for dietary P restriction exist, but the bioavailability of P in food should also be considered when making appropriate food choices to maintain patients' quality of life. Here, we propose the ""Phosphatemic Index"" (PI) as a novel tool for evaluating dietary P load based on P bioavailability; we also evaluated the effect of continuous intake of different PI foods in mixed meals on serum intact fibroblast growth factor 23 concentration.
DESIGN AND METHODS


A 2-stage crossover study was conducted: Study 1: 20 healthy participants consumed 10 different foods containing 200 mg of P, and the PI was calculated from the area under the curve of a time versus serum P concentration curve; Study 2: 10 healthy participants consumed 4 different test meals (low, medium, or high PI meals or a control) over a 5-day period.
RESULTS


Study 1 showed milk and dairy products had high PI values, pork and ham had medium PI values, and soy and tofu had low PI values. In Study 2, ingestion of high PI test meals showed higher fasting serum intact fibroblast growth factor 23 levels and lower serum 1,25-dihydroxyvitamin D levels compared with ingestion of low PI test meals.
CONCLUSION


These findings suggest that the PI can usefully evaluate the dietary P load of various foods and may help to make appropriate food choices for dietary P restriction in CKD patients.",2020,"In Study 2, ingestion of high PI test meals showed higher fasting serum intact fibroblast growth factor 23 levels and lower serum 1,25-dihydroxyvitamin D levels compared with ingestion of low PI test meals.
","['patients with chronic kidney disease (CKD) and the wider population', '10 healthy participants', 'Study 1: 20 healthy participants']","['consumed 4 different test meals (low, medium, or high PI meals or a control', 'consumed 10 different foods containing 200\xa0mg of P', 'Dietary phosphorus (P) restriction']","['PI values, pork and ham had medium PI values, and soy and tofu had low PI values', 'fasting serum intact fibroblast growth factor 23 levels and lower serum 1,25-dihydroxyvitamin D levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0080014', 'cui_str': 'Dietary Phosphorus'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0452867', 'cui_str': 'Pork'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0453233', 'cui_str': 'Tofu'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0370232', 'cui_str': '1,25-dihydroxyvitamin D'}]",,0.0180668,"In Study 2, ingestion of high PI test meals showed higher fasting serum intact fibroblast growth factor 23 levels and lower serum 1,25-dihydroxyvitamin D levels compared with ingestion of low PI test meals.
","[{'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Narasaki', 'Affiliation': 'Department of Clinical Nutrition and Food Management, Tokushima University Graduate School of Nutrition and Biosciences, Tokushima, Japan; Japan Society for the Promotion of Science, Tokyo, Japan.'}, {'ForeName': 'Michiyo', 'Initials': 'M', 'LastName': 'Yamasaki', 'Affiliation': 'Department of Clinical Nutrition and Food Management, Tokushima University Graduate School of Nutrition and Biosciences, Tokushima, Japan.'}, {'ForeName': 'Sayaka', 'Initials': 'S', 'LastName': 'Matsuura', 'Affiliation': 'Department of Clinical Nutrition and Food Management, Tokushima University Graduate School of Nutrition and Biosciences, Tokushima, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Morinishi', 'Affiliation': 'Department of Clinical Nutrition and Food Management, Tokushima University Graduate School of Nutrition and Biosciences, Tokushima, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Clinical Nutrition and Food Management, Tokushima University Graduate School of Nutrition and Biosciences, Tokushima, Japan.'}, {'ForeName': 'Mami', 'Initials': 'M', 'LastName': 'Matsuno', 'Affiliation': 'Department of Clinical Nutrition and Food Management, Tokushima University Graduate School of Nutrition and Biosciences, Tokushima, Japan.'}, {'ForeName': 'Misaki', 'Initials': 'M', 'LastName': 'Katsumoto', 'Affiliation': 'Department of Clinical Nutrition and Food Management, Tokushima University Graduate School of Nutrition and Biosciences, Tokushima, Japan.'}, {'ForeName': 'Sachi', 'Initials': 'S', 'LastName': 'Nii', 'Affiliation': 'Department of Clinical Nutrition and Food Management, Tokushima University Graduate School of Nutrition and Biosciences, Tokushima, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Fushitani', 'Affiliation': 'Department of Clinical Nutrition and Food Management, Tokushima University Graduate School of Nutrition and Biosciences, Tokushima, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Sugihara', 'Affiliation': 'Department of Clinical Nutrition and Food Management, Tokushima University Graduate School of Nutrition and Biosciences, Tokushima, Japan.'}, {'ForeName': 'Tsuneyuki', 'Initials': 'T', 'LastName': 'Noda', 'Affiliation': 'Saga Nutraceuticals Research Institute, Otsuka Pharmaceutical Co., Ltd., Yoshinogari, Saga, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Yoneda', 'Affiliation': 'Saga Nutraceuticals Research Institute, Otsuka Pharmaceutical Co., Ltd., Yoshinogari, Saga, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Masuda', 'Affiliation': 'Department of Clinical Nutrition and Food Management, Tokushima University Graduate School of Nutrition and Biosciences, Tokushima, Japan.'}, {'ForeName': 'Hisami', 'Initials': 'H', 'LastName': 'Yamanaka-Okumura', 'Affiliation': 'Department of Clinical Nutrition and Food Management, Tokushima University Graduate School of Nutrition and Biosciences, Tokushima, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Takeda', 'Affiliation': 'Department of Clinical Nutrition and Food Management, Tokushima University Graduate School of Nutrition and Biosciences, Tokushima, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Sakaue', 'Affiliation': 'Department of Nutrition and Metabolism, Tokushima University Graduate School of Nutrition and Biosciences, Tokushima, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Jin-ai University, Echizen, Fukui, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Taketani', 'Affiliation': 'Department of Clinical Nutrition and Food Management, Tokushima University Graduate School of Nutrition and Biosciences, Tokushima, Japan. Electronic address: taketani@tokushima-u.ac.jp.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2020.02.005']
2026,32778472,"Letter to Editor ""Effects of handwriting exercise on functional outcome in Parkinson disease: A randomized controlled trial"".",,2020,,['Parkinson disease'],['handwriting exercise'],['functional outcome'],"[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.11164,,"[{'ForeName': 'Manpreet', 'Initials': 'M', 'LastName': 'Kaur', 'Affiliation': 'Department of Neuro-Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (deemed to be University), Mullana, Ambala, Haryana 133207, India. Electronic address: priyuarora8427@gmail.com.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': 'Department of Neuro-Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (deemed to be University), Mullana, Ambala, Haryana 133207, India. Electronic address: sharma.nidhi.physio@mmumullana.org.'}, {'ForeName': 'Adarsh Kumar', 'Initials': 'AK', 'LastName': 'Srivastav', 'Affiliation': 'University Research Fellow, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (deemed to be University), Mullana, Ambala, Haryana 133207, India. Electronic address: adarsh.srivastav@mmumullana.org.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2020.06.020']
2027,32778489,"Polidocanol Plus Glucose Versus Glucose Alone for the Treatment of Telangiectasias: Triple Blind, Randomised Controlled Trial (PG3T).","OBJECTIVE


The aim of this study was to compare the effectiveness and safety of two sclerosing agents used to treat telangiectasias in the lower limbs: 0.2% polidocanol + 70% hypertonic glucose (HG) vs. 75% HG alone.
METHODS


A prospective, randomised, triple blind, controlled, parallel group trial with patients randomly assigned in a 1:1 ratio between January and December 2015, with a two month follow up, from a single academic medical centre in Brazil, was carried out. Participants were women aged 18-65 years with telangiectasias on the lateral aspect of one thigh, classified as C1EpAsPn who underwent sclerotherapy in a single session with 0.2% polidocanol + 70% HG or 75% HG alone to treat the telangiectasias on an area limited by a rectangular template. The primary effectiveness endpoint was elimination of 75% of the telangiectasias within 60 days vs. the pre-treatment pattern. The length of vessels was measured on images obtained before and after treatment using ImageJ software. Safety outcomes were analysed immediately, 7 days, and 60 days after the treatment, and included pigmentation.
RESULTS


A total of 115 patients were included, 98 of whom completed the study. Sclerotherapy with 0.2% polidocanol + 70% HG was significantly more effective than with 75% HG alone to treat telangiectasias in the target area (82.2% vs. 63.9%; p < .001); considering a minimum improvement of 75%, there was a 0.49 risk reduction (95% confidence interval 0.24-0.98; p = .047). No severe adverse events occurred in either group. Pigmentation was the most common minor adverse event and was significantly shorter in length in the group treated with 0.2% polidocanol + 70% HG (median 0 cm vs. 0.5 cm, respectively; p = .033).
CONCLUSION


Polidocanol 0.2% plus 70% HG had better results than 75% HG alone in sclerosing telangiectasias. No severe adverse events occurred. Pigmentation occurred in both groups and was shorter in length in the group treated with 0.2% polidocanol + 70% HG.",2020,Pigmentation occurred in both groups and was shorter in length in the group treated with 0.2% polidocanol + 70% HG.,"['A total of 115 patients were included, 98 of whom completed the study', 'patients randomly assigned in a 1:1 ratio between January and December 2015, with a two month follow up, from a single academic medical centre in Brazil, was carried out', 'Telangiectasias', 'Participants were women aged 18-65 years with telangiectasias on the lateral aspect of one thigh, classified as C1EpAsPn who underwent']","['polidocanol', 'Sclerotherapy with 0.2% polidocanol', 'Polidocanol Plus Glucose Versus Glucose Alone', 'Polidocanol', 'sclerotherapy', 'polidocanol\xa0+ 70% hypertonic glucose (HG) vs. 75% HG alone', 'polidocanol\xa0+ 70% HG or 75% HG alone']","['Safety outcomes', 'severe adverse events', 'elimination of 75% of the telangiectasias', 'treat telangiectasias', 'length of vessels', 'effectiveness and safety', 'Pigmentation']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0039446', 'cui_str': 'Telangiectasis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]","[{'cui': 'C0071330', 'cui_str': 'polidocanol'}, {'cui': 'C0036435', 'cui_str': 'Injection of sclerosing agent'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0039446', 'cui_str': 'Telangiectasis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}]",115.0,0.256324,Pigmentation occurred in both groups and was shorter in length in the group treated with 0.2% polidocanol + 70% HG.,"[{'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Bertanha', 'Affiliation': 'Department of Surgery and Orthopedics of Botucatu Medical School, São Paulo State University Júlio de Mesquita Filho, UNESP, Botucatu, SP, Brazil. Electronic address: matheusbertanha@gmail.com.'}, {'ForeName': 'Winston B', 'Initials': 'WB', 'LastName': 'Yoshida', 'Affiliation': 'Department of Surgery and Orthopedics of Botucatu Medical School, São Paulo State University Júlio de Mesquita Filho, UNESP, Botucatu, SP, Brazil.'}, {'ForeName': 'Paula A', 'Initials': 'PA', 'LastName': 'Bueno de Camargo', 'Affiliation': 'Department of Surgery and Orthopedics of Botucatu Medical School, São Paulo State University Júlio de Mesquita Filho, UNESP, Botucatu, SP, Brazil.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Moura', 'Affiliation': 'Department of Surgery and Orthopedics of Botucatu Medical School, São Paulo State University Júlio de Mesquita Filho, UNESP, Botucatu, SP, Brazil.'}, {'ForeName': 'Dênia', 'Initials': 'D', 'LastName': 'Reis de Paula', 'Affiliation': 'Botucatu Medical School, São Paulo State University Júlio de Mesquita Filho, UNESP, Botucatu, SP, Brazil.'}, {'ForeName': 'Carlos R', 'Initials': 'CR', 'LastName': 'Padovani', 'Affiliation': 'Department of Statistics of the Botucatu Biosciences Institute, São Paulo State University Júlio de Mesquita Filho, UNESP, Botucatu, SP, Brazil.'}, {'ForeName': 'Marcone L', 'Initials': 'ML', 'LastName': 'Sobreira', 'Affiliation': 'Department of Surgery and Orthopedics of Botucatu Medical School, São Paulo State University Júlio de Mesquita Filho, UNESP, Botucatu, SP, Brazil.'}]",European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery,['10.1016/j.ejvs.2020.07.007']
2028,32778521,Feasibility of hippocampal avoidance whole brain radiation in patients with hippocampal involvement: Data from a prospective study.,"PURPOSE


Among patients with brain metastases, hippocampal avoidance whole brain radiation (HA-WBRT) preserves neurocognitive function relative to conventional WBRT but the feasibility of hippocampal sparing in patients with metastases in/near the hippocampus is unknown. We identified the incidence of hippocampal/perihippocampal metastases and evaluated the feasibility of HA-WBRT in such patients.
MATERIALS/METHODS


Dosimetric data from 34 patients randomized to HA-WBRT (30 Gy/10 fractions) in a phase III trial (NCT03075072) comparing HA-WBRT to stereotactic radiation in patients with 5 to 20 brain metastases were analyzed. Patients with metastases in/near the hippocampi received HA-WBRT with prioritization of tumor coverage over hippocampal avoidance. Target coverage and hippocampal sparing metrics were compared between patients with targets in/near the hippocampus versus not.
RESULTS


In total, 9 of 34 (26%) patients had targets in the hippocampus and an additional 5 of 34 (15%) patients had targets in the hippocampal avoidance zone (HAZ, hippocampus plus 5 mm expansion) but outside the hippocampus. Patients with targets within the hippocampus and those with targets in the HAZ but outside the hippocampus were spared 34% and 73% of the ipsilateral mean biologically equivalent prescription dose, respectively. Of the latter cohort, 88% and 25% met conventional hippocampal sparing metrics of Dmin ≤ 9 Gy and Dmax ≤ 16 Gy, respectively. Among 11 patients with unilateral hippocampal/perihippocampal involvement, the uninvolved/contralateral hippocampus was limited to Dmin ≤ 9 Gy and Dmax ≤ 17 Gy in all cases.
CONCLUSIONS


In this study, a substantial percentage of patients with 5 to 20 brain metastases harbored metastases in/near the hippocampus. In such cases, minimizing hippocampal dose while providing tumor coverage was feasible and may translate to neurocognitive protection.",2020,"Patients with targets within the hippocampus and those with targets in the HAZ but outside the hippocampus were spared 34% and 73% of the ipsilateral mean biologically equivalent prescription dose, respectively.","['Patients with metastases in/near the hippocampi received', 'patients with 5 to 20 brain metastases', 'patients with 5 to 20 brain metastases harbored metastases in/near the hippocampus', '34 patients randomized to', 'patients with brain metastases', 'patients with hippocampal involvement', '11 patients with unilateral hippocampal/perihippocampal involvement, the uninvolved/contralateral hippocampus']","['hippocampal avoidance whole brain radiation', 'hippocampal avoidance whole brain radiation (HA-WBRT', 'HA-WBRT to stereotactic radiation', 'HA-WBRT']",['Target coverage and hippocampal sparing metrics'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205429', 'cui_str': 'Uninvolved'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}]","[{'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C4704923', 'cui_str': 'Stereotactic Radiation'}]","[{'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]",11.0,0.0480422,"Patients with targets within the hippocampus and those with targets in the HAZ but outside the hippocampus were spared 34% and 73% of the ipsilateral mean biologically equivalent prescription dose, respectively.","[{'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': ""Harvard Medical School, Boston, MA 02115, USA; Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, MA, 02115, USA. Electronic address: grace0691@gmail.com.""}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Besse', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, MA, 02115, USA; Broad Institute, Cambridge, MA 02142, USA. Electronic address: lbesse@broadinstitute.org.""}, {'ForeName': 'Nayan', 'Initials': 'N', 'LastName': 'Lamba', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, MA, 02115, USA. Electronic address: nlamba@partners.org.""}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Hancox', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, MA, 02115, USA. Electronic address: chancox@bwh.harvard.edu.""}, {'ForeName': 'Iquan', 'Initials': 'I', 'LastName': 'Usta', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, MA, 02115, USA. Electronic address: iusta@bwh.harvard.edu.""}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Hacker', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, MA, 02115, USA. Electronic address: fhacker@bwh.harvard.edu.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Catalano', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA 02115, USA. Electronic address: catalano@hsph.harvard.edu.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Brown', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, MN 55905, USA. Electronic address: brown.paul@mayo.edu.'}, {'ForeName': 'Shyam', 'Initials': 'S', 'LastName': 'Tanguturi', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, MA, 02115, USA. Electronic address: stanguturi@partners.org.""}, {'ForeName': 'Itai', 'Initials': 'I', 'LastName': 'Pashtan', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, MA, 02115, USA.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, MA, 02115, USA. Electronic address: ipashtan@partners.org.""}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Haas-Kogan', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, MA, 02115, USA. Electronic address: jphillips@bwh.harvard.edu.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Alexander', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, MA, 02115, USA. Electronic address: dhaas-kogan@bwh.harvard.edu.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cagney', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, MA, 02115, USA. Electronic address: dcagney@bwh.harvard.edu.""}, {'ForeName': 'Ayal', 'Initials': 'A', 'LastName': 'Aizer', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, MA, 02115, USA. Electronic address: ayal_aizer@dfci.harvard.edu.""}]",Medical dosimetry : official journal of the American Association of Medical Dosimetrists,['10.1016/j.meddos.2020.06.004']
2029,32778721,Acute increases in brain-derived neurotrophic factor following high or moderate-intensity exercise is accompanied with better cognition performance in obese adults.,"The purpose of this study was to test if different intensities of aerobic exercise could influence abdominal fat, isoforms of BDNF and executive function. Twenty obese men (30.0 ± 5.4 years old; 34.4 ± 3.5 kg/m 2 ) were randomized to moderate-intensity continuous training (MICT, n = 10) and high-intensity intermittent training (HIIT, n = 10) three times a week for 6 weeks, with isoenergetic energetic expenditure for each exercise session (~ 300 kcal) between conditions. Abdominal fat was assessed pre- and post-intervention; executive function (Coding subtest from BETA-III non-verbal intelligence test and Stroop Color and Word Test), concentrations of mBDNF and proBDNF were assessed in response to acute exercise pre- and post-intervention. Abdominal fat did not change in either group. There was a significant increase in mBDNF immediately after acute exercise in both groups before and after intervention. proBDNF did not present changes acutely nor after 6 weeks. Executive function presented a main effect of time at pre- and post-intervention time-points Stroop Word and Stroop Color and Coding subtest presented improved performance from pre- to post-acute exercise session, in both groups. In conclusion, executive function improvements and acute exercise session-induced increases in mBDNF concentration were found from pre- to post-exercise intervention similarly between MICT and HIIT in obese men.",2020,"Executive function presented a main effect of time at pre- and post-intervention time-points Stroop Word and Stroop Color and Coding subtest presented improved performance from pre- to post-acute exercise session, in both groups.","['obese men', 'Twenty obese men (30.0\u2009±\u20095.4\xa0years old; 34.4\u2009±\u20093.5\xa0kg/m 2 ', 'obese adults']","['pre- and post-intervention time-points Stroop Word and Stroop Color and Coding subtest presented improved performance from pre- to post-acute exercise session', 'moderate-intensity continuous training (MICT, n\u2009=\u200910) and high-intensity intermittent training (HIIT, n\u2009=\u200910) three times a week for 6\xa0weeks, with isoenergetic energetic expenditure for each exercise session', 'proBDNF', 'aerobic exercise']","['mBDNF concentration', 'abdominal fat, isoforms of BDNF and executive function', 'Abdominal fat was assessed pre- and post-intervention; executive function (Coding subtest from BETA-III non-verbal intelligence test and Stroop Color and Word Test), concentrations of mBDNF and proBDNF', 'mBDNF', 'Abdominal fat', 'cognition performance']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}, {'cui': 'C0597298', 'cui_str': 'Isoforms'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0021705', 'cui_str': 'Intelligence test'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",20.0,0.0297667,"Executive function presented a main effect of time at pre- and post-intervention time-points Stroop Word and Stroop Color and Coding subtest presented improved performance from pre- to post-acute exercise session, in both groups.","[{'ForeName': 'Daniela Sayuri', 'Initials': 'DS', 'LastName': 'Inoue', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post-Graduation Program in Movement Sciences, Department of Physical Education, School of Technology and Sciences, State University (UNESP), Presidente Prudente, São Paulo, Brazil. dsinoue@gmail.com.'}, {'ForeName': 'Paula Alves', 'Initials': 'PA', 'LastName': 'Monteiro', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post-Graduation Program in Movement Sciences, Department of Physical Education, School of Technology and Sciences, State University (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Gerosa-Neto', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post-Graduation Program in Movement Sciences, Department of Physical Education, School of Technology and Sciences, State University (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Priscilla Rodrigues', 'Initials': 'PR', 'LastName': 'Santana', 'Affiliation': 'Psychology Department, Universidade São Judas Tadeu and Fundação Santo André, São Paulo, Brazil.'}, {'ForeName': 'Fernando Pierin', 'Initials': 'FP', 'LastName': 'Peres', 'Affiliation': 'Medicine Department, Universidade Do Oeste Paulista, São Paulo, Brazil.'}, {'ForeName': 'Kate M', 'Initials': 'KM', 'LastName': 'Edwards', 'Affiliation': 'Charles Perkins Centre, Faculty of Health Sciences, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Fabio Santos', 'Initials': 'FS', 'LastName': 'Lira', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post-Graduation Program in Movement Sciences, Department of Physical Education, School of Technology and Sciences, State University (UNESP), Presidente Prudente, São Paulo, Brazil. fabio.lira@unesp.br.'}]",Scientific reports,['10.1038/s41598-020-70326-1']
2030,32779375,"A randomized, split-face, double-blind, comparative study of the safety and efficacy of small- and large-particle hyaluronic acid fillers for the treatment of nasolabial folds.","BACKGROUND


Injections of hyaluronic acid (HA) for tissue augmentation are one of the most common aesthetic treatments performed worldwide. However, few studies have compared the safety and efficacy of small- and large-particle HA (SP-HA; LP-HA).
AIM


Assess and compare the safety and efficacy of SP-HA and LP-HA for the correction of nasolabial folds (NLFs).
METHODS


A prospective, split face, triple blind study design was used. Ten female subjects were recruited. Patients underwent treatment at baseline, an optional touch up at Week 2 and a follow-up visit at Week 4. At Weeks 2 and 4, a blinded reviewer assessed the patients using the Global Aesthetic Improvement Scale (GAIS) and Wrinkle Severity Rating Scale (WSRS); and subjects completed the Patient Satisfaction Questionnaire (PSQ). At all visits, 3-dimensional imagery and ultrasonography of patients' NLFs were captured. Adverse events (AEs) were evaluated by the Investigator and recorded by subjects in diaries.
RESULTS


The GAIS response rate, defined as ≥ ""improved"" from baseline was between 90 (2 weeks) and 100% (1 month) for SP-HA and was 100% for LP-HA, at both visits. Paired-samples t-tests revealed significant differences in the change in WSRS scores between groups, at both visits (p <0.01). Differences in the clinical effect and lifting capacity of both products were observed in 3-dimensional imagery and ultrasonography. Treatment volumes varied, with 61.32% more SP-HA being required than LP-HA for achieving a ≥ one-grade WSRS improvement. There were no severe AEs throughout the trial, nor AEs related to the investigational device.
CONCLUSIONS


LP-HA demonstrates better efficacy for correcting bony resorption in the nasal pyriform region.",2020,"Paired-samples t-tests revealed significant differences in the change in WSRS scores between groups, at both visits (p <0.01).","['Ten female subjects were recruited', 'nasolabial folds']","['hyaluronic acid (HA', 'small- and large-particle hyaluronic acid fillers', 'SP-HA and LP-HA']","['3-dimensional imagery and ultrasonography', 'GAIS response rate, defined as ≥ ""improved', 'Global Aesthetic Improvement Scale (GAIS) and Wrinkle Severity Rating Scale (WSRS); and subjects completed the Patient Satisfaction Questionnaire (PSQ', 'Adverse events (AEs', 'WSRS scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0221328', 'cui_str': 'Nasolabial sulcus structure'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0729441', 'cui_str': 'Filler'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",10.0,0.0475735,"Paired-samples t-tests revealed significant differences in the change in WSRS scores between groups, at both visits (p <0.01).","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Nikolis', 'Affiliation': 'Erevna Innovations Clinical Research Unit, Division of Plastic Surgery McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Kaitlyn M', 'Initials': 'KM', 'LastName': 'Enright', 'Affiliation': 'Erevna Innovations Clinical Research Unit, Westmount, Quebec, Canada.'}, {'ForeName': 'Åke', 'Initials': 'Å', 'LastName': 'Öhrlund', 'Affiliation': 'Galderma Aesthetics, Uppsala, Uppland, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Winlöf', 'Affiliation': 'Galderma Aesthetics, Uppsala, Uppland, Sweden.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Cotofana', 'Affiliation': 'Department of Clinical Anatomy, Mayo Clinic College of Medicine and Science, Rochester, Minnesota, United States.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13668']
2031,32779386,Over-the-counter bite splints: A randomized controlled trial of compliance and efficacy.,"BACKGROUND


Occlusal splints are often used to curb the impacts of sleep bruxism (SB) on the dentition, and over-the-counter (OCT) options are becoming increasingly popular. OTC splints are usually fabricated at home by patients, but not routinely evaluated by dental professionals. It is unclear how OCT splints compare with more traditional splints that receive dental oversight.
OBJECTIVES


The present randomized controlled study tested how an OTC splint compared with a gold standard bite splint in terms of patient compliance (primary outcome) and efficacy (secondary outcomes).
METHODS


Sixty-seven subjects were randomly assigned to receive either the OTC (SOVA, N = 35) splint or the gold standard ""Michigan"" bite splint (MI, N = 32), with 61 completing the study (SOVA, N = 30; MI, N = 31). OTC-splint subjects were required to fabricate their splints to clinically acceptable standards. Both groups wore the splints nightly for four months. Compliance was measured via daily diary. Efficacy outcomes evaluated stability, retention, periodontal health, night-time rhythmic masticatory muscle activity (RMMA), and material wear.
RESULTS


OTC-splint subjects had difficulty fabricating splints to clinically acceptable standards. The number of night-time RMMA bursts was significantly greater for the OTC splint group. Compliance and all other efficacy measurements were not significantly different between-groups.
CONCLUSIONS


The results support the potential use of OTC splints for curbing the impacts of SB. However, the results strongly suggest that dentists should be actively engaged in overseeing patients' use of self-fabricated appliances. This clinical trial is registered at ClinicalTrials.gov, Identifier number NCT02340663.",2020,"Compliance and all other efficacy measurements were not significantly different between-groups.
",['Sixty-seven subjects'],"['OTC (SOVA, N = 35) splint or the gold standard ""Michigan"" bite splint', 'OTC splint', 'gold standard bite splint', 'OTC splints']","['number of night-time RMMA bursts', 'efficacy measurements', 'stability, retention, periodontal health, night-time rhythmic masticatory muscle activity (RMMA), and material wear']","[{'cui': 'C4517852', 'cui_str': '67'}]","[{'cui': 'C0013231', 'cui_str': 'Drugs, Non-Prescription'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0162528', 'cui_str': 'Occlusal appliance'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0024890', 'cui_str': 'Structure of muscle of mastication'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0520510', 'cui_str': 'Material'}]",67.0,0.0531037,"Compliance and all other efficacy measurements were not significantly different between-groups.
","[{'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Gerstner', 'Affiliation': 'Department of Biologic and Materials Sciences and Prosthodontics, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yao', 'Affiliation': 'University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Krishnapriya', 'Initials': 'K', 'LastName': 'Siripurapu', 'Affiliation': 'Department of Biologic and Materials Sciences and Prosthodontics, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Hadel', 'Initials': 'H', 'LastName': 'Aljanabi', 'Affiliation': 'Department of Biologic and Materials Sciences and Prosthodontics, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Decker', 'Affiliation': 'Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ludkin', 'Affiliation': 'Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Sinacola', 'Affiliation': 'Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Frimenko', 'Affiliation': 'University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Callaghan', 'Affiliation': 'Department of Biologic and Materials Sciences and Prosthodontics, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Penoyer', 'Affiliation': 'Department of Biologic and Materials Sciences and Prosthodontics, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Tewksbury', 'Affiliation': 'Department of Biologic and Materials Sciences and Prosthodontics, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.'}]",Clinical and experimental dental research,['10.1002/cre2.315']
2032,32779407,Intratracheal administration of budesonide with surfactant in very low birth weight infants to prevent bronchopulmonary dysplasia.,"BACKGROUND AND OBJECTIVES


Respiratory distress syndrome (RDS) is a major cause of early postnatal death in preterm infants. Bronchopulmonary dysplasia (BPD) is one of the most fatal chronic respiratory complications of preterm infants after management of RDS. Anti-inflammatory therapy with corticosteroid is one of the effective treatments to prevent BPD. However, systemic administration of corticosteroid is not recommended because of long-term adverse effects. We studied the effect of early intratracheal instillation of budesonide with surfactant in preterm infants with severe RDS.
METHOD


Very low birth weight infants (VLBWIs) weighing less than 1,500 g who were admitted to the neonatal intensive care unit (NICU) of Busan Paik Hospital between January 2018 and December 2018 and diagnosed with severe RDS were enrolled. The treatment group was given a mixture of budesonide and surfactant (calfactant) while the control group was given surfactant (calfactant) only.
RESULTS


Surfactant re-dosing, duration of mechanical ventilation, BPD, mortality, and retinopathy of prematurity (≥ stage 2) were not different between the two groups though there were decreasing trends in the treatment group compared to those in the control group. The duration of hospital stay was longer in the control group with statistical significance.
CONCLUSION


Early intratracheal administration of budesonide with surfactant in preterm infants with severe RDS might decrease BPD and mortality without disturbing surfactant function. Further studies with different preparations of surfactants with a large number of preterm infants are required.",2020,"The duration of hospital stay was longer in the control group with statistical significance.
","['preterm infants after management of RDS', 'preterm infants', 'Very low birth weight infants (VLBWIs) weighing less than 1,500 g who were admitted to the neonatal intensive care unit (NICU) of Busan Paik Hospital between January 2018 and December 2018 and diagnosed with severe RDS were enrolled', 'Respiratory distress syndrome (RDS', 'very low birth weight infants to prevent bronchopulmonary dysplasia', 'Bronchopulmonary dysplasia (BPD', 'preterm infants with severe RDS']","['corticosteroid', 'budesonide with surfactant', 'mixture of budesonide and surfactant (calfactant) while the control group was given surfactant (calfactant) only']","['BPD and mortality', 'duration of mechanical ventilation, BPD, mortality, and retinopathy of prematurity (≥ stage 2', 'duration of hospital stay']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0035344', 'cui_str': 'Retinopathy of prematurity'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.0632958,"The duration of hospital stay was longer in the control group with statistical significance.
","[{'ForeName': 'Minji', 'Initials': 'M', 'LastName': 'Heo', 'Affiliation': 'Department of Pediatrics, Busan Paik Hospital, Inje University College of Medicine, Busan, Korea.'}, {'ForeName': 'Ga Won', 'Initials': 'GW', 'LastName': 'Jeon', 'Affiliation': 'Department of Pediatrics, Busan Paik Hospital, Inje University College of Medicine, Busan, Korea.'}]",The Turkish journal of pediatrics,['10.24953/turkjped.2020.04.004']
2033,32779416,Bee product efficacy in children with upper respiratory tract infections.,"BACKGROUND AND OBJECTIVES


The most common infectious disease in children is acute upper respiratory tract infection (URTI). Many drugs, especially antitussive drugs, are used for symptomatic treatment. Bee products (propolis, royal jelly, and honey) have antiviral, antibacterial, and antioxidant properties, and they have synergistic effects with antibiotics. The aim of this study was to evaluate the effectiveness of a mixture of bee products in URTI in children.
METHODS


The patients were divided into four groups consisting of two bacterial groups receiving either antibiotics or antibiotics + bee products and two viral groups treated with either placebo or bee products. Disease severity and improvement duration were assessed by the Canadian Acute Respiratory Illness and Flu Scale (CARIFS) Score.
RESULTS


One hundred and four patients (59 male, 56.7%; 45 female, 43.3%) aged between 5‒12 years were included in the study. Fifty patients (48%) were evaluated for bacterial infections and 54 (52%) for viral infections. Patients with viral infection receiving a mixture product showed earlier improvement, compared to placebo group. CARIFS scores were significantly lower in antibiotic + mixture group on day-2 and day-4, compared to antibiotic alone group (p < 0.05). None of the patients developed any reactions or side effects to the mixture product.
CONCLUSIONS


Bee products are effective in symptomatic treatment of upper respiratory tract infections. Bee products can be considered as a good treatment option because the available drugs already used for symptomatic treatment are not cost effective and can also have serious side effects in children.",2020,"CARIFS scores were significantly lower in antibiotic + mixture group on day-2 and day-4, compared to antibiotic alone group (p < 0.05).","['One hundred and four patients (59 male, 56.7%; 45 female, 43.3%) aged between 5‒12 years were included in the study', 'children is acute upper respiratory tract infection (URTI', 'children', 'Patients with viral infection receiving a', 'Fifty patients (48%) were evaluated for bacterial infections and 54 (52%) for viral infections', 'children with upper respiratory tract infections']","['mixture product', 'antibiotic + mixture', 'antibiotics or antibiotics + bee products and two viral groups treated with either placebo or bee products', 'placebo']","['Disease severity and improvement duration', 'Canadian Acute Respiratory Illness and Flu Scale (CARIFS) Score', 'CARIFS scores']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0264222', 'cui_str': 'Acute upper respiratory infection'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0004623', 'cui_str': 'Bacterial infectious disease'}]","[{'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0004923', 'cui_str': 'Bee'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",50.0,0.0357952,"CARIFS scores were significantly lower in antibiotic + mixture group on day-2 and day-4, compared to antibiotic alone group (p < 0.05).","[{'ForeName': 'Yılmaz', 'Initials': 'Y', 'LastName': 'Seçilmiş', 'Affiliation': 'Division of Pediatric Emergency, Department of Pediatrics, Erciyes University Faculty of Medicine, Kayseri.'}, {'ForeName': 'Sibel', 'Initials': 'S', 'LastName': 'Silici', 'Affiliation': 'Department of Agricultural Biotechnology, Erciyes University Faculty of Agriculture, Kayseri, Turkey.'}]",The Turkish journal of pediatrics,['10.24953/turkjped.2020.04.013']
2034,32779452,[Antiangiogenic therapy in high-risk keratoplasty].,"PURPOSE


To analyze the effectiveness and safety of VEGF inhibitor used to improve keratoconus transplant survival in patients with corneal neovascularization as stand-alone and in combination with laser coagulation of ingrowing vessels before keratoplasty.
MATERIAL AND METHODS


The study included 56 patients (56 eyes) with corneal opacifications of various etiology complicated by corneal neovascularization (CNV). The patients were divided into three groups. The 1st group included 27 patients with diffuse CNV who were undergoing an antiangiogenic therapy using anti-VEGF drug, the 2nd group - 14 patients with stem cell CNV who underwent laser coagulation of major corneal vessels combined with subconjunctival administration of drug before keratoplasty; the control group consisted of 15 patients with mixed type CNV who were undergoing conventional treatment without antiangiogenic therapy.
RESULTS


During the follow-up (24.5±4.84 months, 4 to 25 months), transplant rejection reaction was recorded in 7 (23%) patients of the 1 st  group, 5 (35%) patients of the 2 nd  group and 9 (60%) patients of the control group.
CONCLUSION


Subconjunctival administration of Aflibercept as a stand-alone measure and in combination with laser coagulation of ingrowing vessels may increase the chances of transparent transplant acceptance in high-risk keratoplasty.",2020,The study included 56 patients (56 eyes) with corneal opacifications of various etiology complicated by corneal neovascularization (CNV).,"['56 patients (56 eyes) with corneal opacifications of various etiology complicated by corneal neovascularization (CNV', 'patients with corneal neovascularization as stand-alone and in combination with laser coagulation of ingrowing vessels before keratoplasty', 'high-risk keratoplasty', '27 patients with diffuse CNV who were undergoing an antiangiogenic therapy using anti-VEGF drug, the 2nd group - 14 patients with stem cell CNV who underwent']","['VEGF inhibitor', 'Antiangiogenic therapy', 'laser coagulation of major corneal vessels combined with subconjunctival administration of drug before keratoplasty; the control group consisted of 15 patients with mixed type CNV who were undergoing conventional treatment without antiangiogenic therapy', 'Aflibercept']","['transplant rejection reaction', 'keratoconus transplant survival', 'chances of transparent transplant acceptance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0449584', 'cui_str': 'Opacification'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0085109', 'cui_str': 'Corneal neovascularization'}, {'cui': 'C0560204', 'cui_str': 'Does stand alone'}, {'cui': 'C0086524', 'cui_str': 'Laser beam photocoagulation'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0010042', 'cui_str': 'Keratoplasty'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C2363719', 'cui_str': 'Antiangiogenic therapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2363719', 'cui_str': 'Antiangiogenic therapy'}, {'cui': 'C0086524', 'cui_str': 'Laser beam photocoagulation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0442183', 'cui_str': 'Subconjunctival'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0010042', 'cui_str': 'Keratoplasty'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0085109', 'cui_str': 'Corneal neovascularization'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C0018129', 'cui_str': 'Graft rejection'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}]",15.0,0.017268,The study included 56 patients (56 eyes) with corneal opacifications of various etiology complicated by corneal neovascularization (CNV).,"[{'ForeName': 'S V', 'Initials': 'SV', 'LastName': 'Trufanov', 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Malozhen', 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Krakhmaleva', 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}, {'ForeName': 'Z V', 'Initials': 'ZV', 'LastName': 'Surnina', 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Pivin', 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Kasparova', 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}]",Vestnik oftalmologii,['10.17116/oftalma202013604111']
2035,32779544,Acute and subacute hemodynamic responses and perception of effort in subjects with chronic Chagas cardiomyopathy submitted to different protocols of inspiratory muscle training: a cross-over trial.,"PURPOSE


This study aimed to evaluate acute and subacute hemodynamic responses and perception of effort in individuals with CCC submitted to different IMT protocols.
MATERIALS AND METHODS


This was a randomized cross-over trial conducted on CCC subjects with systolic left ventricular dysfunction (<45% left ventricular ejection fraction) without or with heart failure (stages B2 and C, respectively). Twenty-one participants performed two IMT protocols, one targeting 60% maximal inspiratory pressure with 3 × 10 repetitions (MIP60) and the other targeting 30% maximal inspiratory pressure (MIP30) with 3 × 20 repetitions with a 2 min recovery between sets for both. MIP60 and MIP30 were performed on the same day with a 2 h washout period. Measurements were taken at baseline, during and 60 min after IMT.
RESULTS


No differences in hemodynamic variables were observed across protocols. The perception of effort increased in both protocols, with higher scores for the MIP30 protocol (β = +1.6,  p  = 0.01; β = +1.1,  p  = 0.02; β = +0.9,  p  = 0.08 for the 1st, 2nd and 3rd sets, respectively).
CONCLUSIONS


There were no differences in hemodynamic responses comparing MIP60 and MIP30 protocols in subjects with CCC. Despite the higher perception of effort during endurance protocol, both protocols can be considered a safe therapeutic strategy. IMPLICATIONS FOR REHABILITATION Despite inspiratory muscle training may result in functional capacity improvements, no previous study evaluated the hemodynamic acute and subacute responses to inspiratory muscle training in chronic Chagas cardiomyopathy. The two inspiratory muscle training protocols (30% and 60% of maximal inspiratory pressure) did not cause significant hemodynamic repercussions in subjects with chronic Chagas cardiomyopathy. Inspiratory muscle training seems to be an effective strategy to improve functional capacity and can be implemented in the rehabilitation programs for patients with Chagas cardiomyopathy. Since no significant adverse responses were observed in any of the hemodynamic parameters during the inspiratory muscle training sessions, these two protocols of inspiratory muscle training (30% and 60% of maximal inspiratory pressure) seems to be safe in subjects with Chagas cardiomyopathy.",2020,"The perception of effort increased in both protocols, with higher scores for the MIP30 protocol (β = +1.6,  p  = 0.01; β = +1.1,  p  = 0.02; β = +0.9,  p  = 0.08 for the 1st, 2nd and 3rd sets, respectively).
","['patients with Chagas cardiomyopathy', 'subjects with chronic Chagas cardiomyopathy', 'individuals with CCC submitted to different IMT protocols', 'subjects with Chagas cardiomyopathy', 'subjects with CCC', 'subjects with systolic left ventricular dysfunction (<45% left ventricular ejection fraction) without or with heart failure (stages B2 and C, respectively']","['IMT protocols, one targeting 60% maximal inspiratory pressure with 3\u2009×\u200910 repetitions (MIP60) and the other targeting 30% maximal inspiratory pressure (MIP30', 'Inspiratory muscle training', 'CCC', 'inspiratory muscle training']","['hemodynamic variables', 'hemodynamic responses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007930', 'cui_str': ""Chagas' disease with heart involvement""}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0334121', 'cui_str': 'Inflammatory myofibroblastic tumor'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0242698', 'cui_str': 'Impaired left ventricular function'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0441783', 'cui_str': 'Stage B2'}]","[{'cui': 'C0334121', 'cui_str': 'Inflammatory myofibroblastic tumor'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",21.0,0.0117769,"The perception of effort increased in both protocols, with higher scores for the MIP30 protocol (β = +1.6,  p  = 0.01; β = +1.1,  p  = 0.02; β = +0.9,  p  = 0.08 for the 1st, 2nd and 3rd sets, respectively).
","[{'ForeName': 'Aline Xavier', 'Initials': 'AX', 'LastName': 'Frota', 'Affiliation': 'Evandro Chagas National Institute of Infectious Disease, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Fernanda de Souza Nogueira Sardinha', 'Initials': 'FSNS', 'LastName': 'Mendes', 'Affiliation': 'Evandro Chagas National Institute of Infectious Disease, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Marcelo Carvalho', 'Initials': 'MC', 'LastName': 'Vieira', 'Affiliation': 'Evandro Chagas National Institute of Infectious Disease, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Roberto Magalhães', 'Initials': 'RM', 'LastName': 'Saraiva', 'Affiliation': 'Evandro Chagas National Institute of Infectious Disease, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Henrique Horta', 'Initials': 'HH', 'LastName': 'Veloso', 'Affiliation': 'Evandro Chagas National Institute of Infectious Disease, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Paula Simplício', 'Initials': 'PS', 'LastName': 'da Silva', 'Affiliation': 'Evandro Chagas National Institute of Infectious Disease, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Gilberto Marcelo', 'Initials': 'GM', 'LastName': 'Sperandio da Silva', 'Affiliation': 'Evandro Chagas National Institute of Infectious Disease, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Andréa Silvestre', 'Initials': 'AS', 'LastName': 'de Sousa', 'Affiliation': 'Evandro Chagas National Institute of Infectious Disease, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Mazzoli-Rocha', 'Affiliation': 'Evandro Chagas National Institute of Infectious Disease, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Henrique Silveira', 'Initials': 'HS', 'LastName': 'Costa', 'Affiliation': 'Physical Therapy Department, Federal University of Jequitinhonha and Mucuri Valleys, Diamantina, Brazil.'}, {'ForeName': 'Luiz Fernando', 'Initials': 'LF', 'LastName': 'Rodrigues Junior', 'Affiliation': 'Department of Research and Education, National Institute of Cardiology, Rio de Janeiro, Brazil.'}, {'ForeName': 'Mauro Felippe Felix', 'Initials': 'MFF', 'LastName': 'Mediano', 'Affiliation': 'Evandro Chagas National Institute of Infectious Disease, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}]",Disability and rehabilitation,['10.1080/09638288.2020.1800837']
2036,32779571,Internet-Based Lifestyle Intervention to Prevent Type 2 Diabetes Through Healthy Habits: Design and 6-Month Usage Results of Randomized Controlled Trial.,"BACKGROUND


Type 2 diabetes can be prevented through lifestyle changes, but sustainable and scalable lifestyle interventions are still lacking. Habit-based approaches offer an opportunity to induce long-term behavior changes.
OBJECTIVE


The purposes of this study were to describe an internet-based lifestyle intervention for people at risk for type 2 diabetes targeted to support formation of healthy habits and explore its user engagement during the first 6 months of a randomized controlled trial (RCT).
METHODS


The app provides an online store that offers more than 400 simple and contextualized habit-forming behavioral suggestions triggered by daily life activities. Users can browse, inspect, and select them; report their performances; and reflect on their own activities. Users can also get reminders, information on other users' activities, and information on the prevention of type 2 diabetes. An unblended parallel RCT was carried out to evaluate the effectiveness of the app in comparison with routine care. User engagement is reported for the first 6 months of the trial based on the use log data of the participants, who were 18- to 70-year-old community-dwelling adults at an increased risk of type 2 diabetes.
RESULTS


Of 3271 participants recruited online, 2909 were eligible to participate in the RCT. Participants were randomized using a computerized randomization system to the control group (n=971), internet-based intervention (digital, n=967), and internet-based intervention with face-to-face group coaching (F2F+digital, n=971). Mean age of control group participants was 55.0 years, digital group 55.2 years, and F2F+digital 55.2 years. The majority of participants were female, 81.1% (787/971) in the control group, 78.3% (757/967) in the digital group, and 80.7% (784/971) in the F2F+digital group. Of the participants allocated to the digital and F2F+digital groups, 99.53% (1929/1938) logged in to the app at least once, 98.55% (1901/1938) selected at least one habit, and 95.13% (1835/1938) reported at least one habit performance. The app was mostly used on a weekly basis. During the first 6 months, the number of active users on a weekly level varied from 93.05% (1795/1929) on week 1 to 51.79% (999/1929) on week 26. The daily use activity was not as high. The digital and F2F+digital groups used the app on a median of 23.0 and 24.5 days and for 79.4 and 85.1 minutes total duration, respectively. A total of 1,089,555 habit performances were reported during the first 6 months. There were no significant differences in the use metrics between the groups with regard to cumulative use metrics.
CONCLUSIONS


Results demonstrate that internet-based lifestyle interventions can be delivered to large groups including community-dwelling middle-aged and older adults, many with limited experience in digital app use, without additional user training. This intermediate analysis of use behavior showed relatively good engagement, with the percentage of active weekly users remaining over 50% at 6 months. However, we do not yet know if the weekly engagement was enough to change the lifestyles of the participants.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03156478; https://clinicaltrials.gov/ct2/show/NCT03156478.",2020,"The majority of participants were female, 81.1% (787/971) in the control group, 78.3% (757/967) in the digital group, and 80.7% (784/971) in the F2F+digital group.","['participants, who were 18- to 70-year-old community-dwelling adults at an increased risk of type 2 diabetes', '2 Diabetes Through Healthy Habits', 'community-dwelling middle-aged and older adults', 'Mean age of control group participants was 55.0 years, digital group 55.2 years, and F2F+digital 55.2 years', '3271 participants recruited online, 2909 were eligible to participate in the RCT', 'people at risk for type 2 diabetes']","['internet-based lifestyle interventions', 'internet-based intervention (digital, n=967), and internet-based intervention with face-to-face group coaching', 'Internet-Based Lifestyle Intervention to Prevent Type', 'internet-based lifestyle intervention']",['number of active users on a weekly level'],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",3271.0,0.0795683,"The majority of participants were female, 81.1% (787/971) in the control group, 78.3% (757/967) in the digital group, and 80.7% (784/971) in the F2F+digital group.","[{'ForeName': 'Marja', 'Initials': 'M', 'LastName': 'Harjumaa', 'Affiliation': 'VTT Technical Research Centre of Finland Ltd, Espoo, Finland.'}, {'ForeName': 'Pilvikki', 'Initials': 'P', 'LastName': 'Absetz', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Miikka', 'Initials': 'M', 'LastName': 'Ermes', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Mattila', 'Affiliation': 'VTT Technical Research Centre of Finland Ltd, Espoo, Finland.'}, {'ForeName': 'Reija', 'Initials': 'R', 'LastName': 'Männikkö', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Tilles-Tirkkonen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Niina', 'Initials': 'N', 'LastName': 'Lintu', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Schwab', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Adil', 'Initials': 'A', 'LastName': 'Umer', 'Affiliation': 'VTT Technical Research Centre of Finland Ltd, Espoo, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Leppänen', 'Affiliation': 'VTT Technical Research Centre of Finland Ltd, Espoo, Finland.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Pihlajamäki', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, Kuopio, Finland.'}]",JMIR diabetes,['10.2196/15219']
2037,32779573,Evaluation of a Stepped-Care eHealth HIV Prevention Program for Diverse Adolescent Men Who Have Sex With Men: Protocol for a Hybrid Type 1 Effectiveness Implementation Trial of SMART.,"BACKGROUND


Adolescent men who have sex with men (AMSM), aged 13 to 18 years, account for more than 80% of teen HIV occurrences. Despite this disproportionate burden, there is a conspicuous lack of evidence-based HIV prevention programs. Implementation issues are critical as traditional HIV prevention delivery channels (eg, community-based organizations, schools) have significant access limitations for AMSM. As such, eHealth interventions, such as our proposed SMART program, represent an excellent modality for delivering AMSM-specific intervention material where youth are.
OBJECTIVE


This randomized trial aimed to test the effectiveness of the SMART program in reducing condom-less anal sex and increasing condom self-efficacy, condom use intentions, and HIV testing for AMSM. We also plan to test whether SMART has differential effectiveness across important subgroups of AMSM based on race and ethnicity, urban versus rural residence, age, socioeconomic status, and participation in an English versus a Spanish version of SMART.
METHODS


Using a sequential multiple assignment randomized trial design, we will evaluate the impact of a stepped-care package of increasingly intensive eHealth interventions (ie, the universal, information-based SMART Sex Ed; the more intensive, selective SMART Squad; and a higher cost, indicated SMART Sessions). All intervention content is available in English and Spanish. Participants are recruited primarily from social media sources using paid and unpaid advertisements.
RESULTS


The trial has enrolled 1285 AMSM aged 13 to 18 years, with a target enrollment of 1878. Recruitment concluded in June 2020. Participants were recruited from 49 US states as well as Puerto Rico and the District of Columbia. Assessments of intervention outcomes at 3, 6, 9, and 12 months are ongoing.
CONCLUSIONS


SMART is the first web-based program for AMSM to take a stepped-care approach to sexual education and HIV prevention. This design indicates that SMART delivers resources to all adolescents, but more costly treatments (eg, video chat counseling in SMART Sessions) are conserved for individuals who need them the most. SMART has the potential to reach AMSM to provide them with a sex-positive curriculum that empowers them with the information, motivation, and skills to make better health choices.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT03511131; https://clinicaltrials.gov/ct2/show/NCT03511131.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/19701.",2020,"CONCLUSIONS


SMART is the first web-based program for AMSM to take a stepped-care approach to sexual education and HIV prevention.","['Diverse Adolescent Men', 'Participants are recruited primarily from social media sources using paid and unpaid advertisements', 'Adolescent men who have sex with men (AMSM), aged 13 to 18 years, account for more than 80% of teen HIV occurrences', 'Participants were recruited from 49 US states as well as Puerto Rico and the District of Columbia', 'enrolled 1285 AMSM aged 13 to 18 years, with a target enrollment of 1878', 'With Men']","['SMART program', 'Stepped-Care eHealth HIV Prevention Program', 'SMART']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0012764', 'cui_str': 'District of Columbia'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]",[],1285.0,0.0576676,"CONCLUSIONS


SMART is the first web-based program for AMSM to take a stepped-care approach to sexual education and HIV prevention.","[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mustanski', 'Affiliation': 'Institute for Sexual and Gender Minority Health and Wellbeing, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Moskowitz', 'Affiliation': 'Institute for Sexual and Gender Minority Health and Wellbeing, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Kevin O', 'Initials': 'KO', 'LastName': 'Moran', 'Affiliation': 'Institute for Sexual and Gender Minority Health and Wellbeing, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Newcomb', 'Affiliation': 'Institute for Sexual and Gender Minority Health and Wellbeing, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Macapagal', 'Affiliation': 'Institute for Sexual and Gender Minority Health and Wellbeing, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Rodriguez-Díaz', 'Affiliation': 'Department of Prevention and Community Health, Milken Institute School of Public Health, George Washington University, Washington, DC, United States.'}, {'ForeName': 'H Jonathon', 'Initials': 'HJ', 'LastName': 'Rendina', 'Affiliation': 'Department of Psychology, Hunter College of the City University of New York (CUNY), New York, NY, United States.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Laber', 'Affiliation': 'Department of Statistics, North Carolina State University, Raleigh, NC, United States.'}, {'ForeName': 'Dennis H', 'Initials': 'DH', 'LastName': 'Li', 'Affiliation': 'Institute for Sexual and Gender Minority Health and Wellbeing, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Matson', 'Affiliation': 'Institute for Sexual and Gender Minority Health and Wellbeing, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Ali J', 'Initials': 'AJ', 'LastName': 'Talan', 'Affiliation': 'Department of Psychology, Hunter College of the City University of New York (CUNY), New York, NY, United States.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Cabral', 'Affiliation': 'Department of Psychology, Hunter College of the City University of New York (CUNY), New York, NY, United States.'}]",JMIR research protocols,['10.2196/19701']
2038,32779607,Effect of various surface treatments on the bond strength of resin luting agent and the surface roughness and surface energy of CAD/CAM materials.,"The aim of this study was to examine the effect of various surface treatments on the bond strength of a resin luting agent and the surface roughness and surface energy of computer-aided design and computer-aided manufacturing (CAD/CAM) materials. Four types of CAD/CAM blocks (Shofu Block HC: BHC; GC Cerasmart: CER; VITA Enamic: ENA; and Lava Ultimate: LAV) were used. All blocks were randomly divided into eight groups based on the surface treatment as follows: no surface treatment (C), airborne-particle abrasion (AA), hydrofluoric acid etching (HA), silane coupling agent application (SL), AA/SL, HA/SL, AA/HA, and AA/HA/SL. The microtensile bond strength (µTBS), surface roughness and surface energy were measured. Three-way ANOVA revealed that all surface treatments significantly influenced the µTBS between the resin luting agent and all types of CAD/CAM materials; however, the effect of each surface treatment on surface roughness and energy was dependent on the CAD/CAM materials.",2020,"The microtensile bond strength (µTBS), surface roughness and surface energy were measured.",[],"['surface treatment as follows: no surface treatment (C), airborne-particle abrasion (AA), hydrofluoric acid etching (HA), silane coupling agent application (SL), AA/SL, HA/SL, AA/HA, and AA/HA/SL']","['microtensile bond strength (µTBS), surface roughness and surface energy', 'surface roughness and energy', 'µTBS']",[],"[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0020274', 'cui_str': 'Hydrofluoric Acid'}, {'cui': 'C0037093', 'cui_str': 'Silanes'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]",,0.0133649,"The microtensile bond strength (µTBS), surface roughness and surface energy were measured.","[{'ForeName': 'Pakorn', 'Initials': 'P', 'LastName': 'Chuenjit', 'Affiliation': 'Advanced Operative Dentistry and Endodontics, The Nippon Dental University Graduate School of Life Dentistry at Niigata.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Department of Operative Dentistry, The Nippon Dental University School of Life Dentistry at Niigata.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Shinkai', 'Affiliation': 'Advanced Operative Dentistry and Endodontics, The Nippon Dental University Graduate School of Life Dentistry at Niigata.'}]",Dental materials journal,['10.4012/dmj.2019-359']
2039,32780021,Effect of Computer Debriefing on Acquisition and Retention of Learning After Screen-Based Simulation of Neonatal Resuscitation: Randomized Controlled Trial.,"BACKGROUND


Debriefing is key in a simulation learning process.
OBJECTIVE


This study focuses on the impact of computer debriefing on learning acquisition and retention after a screen-based simulation training on neonatal resuscitation designed for midwifery students.
METHODS


Midwifery students participated in 2 screen-based simulation sessions, separated by 2 months, session 1 and session 2. They were randomized in 2 groups. Participants of the debriefing group underwent a computer debriefing focusing on technical skills and nontechnical skills at the end of each scenario, while the control group received no debriefing. In session 1, students participated in 2 scenarios of screen-based simulation on neonatal resuscitation. During session 2, the students participated in a third scenario. The 3 scenarios had an increasing level of difficulty, with the first representing the baseline level. Assessments included a knowledge questionnaire on neonatal resuscitation, a self-efficacy rating, and expert evaluation of technical skills as per the Neonatal Resuscitation Performance Evaluation (NRPE) score and of nontechnical skills as per the Anaesthetists' Non-Technical Skills (ANTS) system. We compared the results of the groups using the Mann-Whitney U test.
RESULTS


A total of 28 midwifery students participated in the study. The participants from the debriefing group reached higher ANTS scores than those from the control group during session 1 (13.25 vs 9; U=47.5; P=.02). Their scores remained higher, without statistical difference during session 2 (10 vs 7.75; P=.08). The debriefing group had higher self-efficacy ratings at session 2 (3 vs 2; U=52; P=.02). When comparing the knowledge questionnaires, the significant baseline difference (13 for debriefing group vs 14.5 for control group, P=.05) disappeared at the end of session 1 and in session 2. No difference was found for the assessment of technical skills between the groups or between sessions.
CONCLUSIONS


Computer debriefing seems to improve nontechnical skills, self-efficacy, and knowledge when compared to the absence of debriefing during a screen-based simulation. This study confirms the importance of debriefing after screen-based simulation.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03844009; https://clinicaltrials.gov/ct2/show/NCT03844009.",2020,"Their scores remained higher, without statistical difference during session 2 (10 vs 7.75; P=.08).","['A total of 28 midwifery students participated in the study', 'Midwifery students participated in 2 screen-based simulation sessions, separated by 2 months, session 1 and session 2', 'midwifery students']","['Computer Debriefing', 'Neonatal Resuscitation', 'computer debriefing focusing on technical skills and nontechnical skills at the end of each scenario, while the control group received no debriefing', 'screen-based simulation training', 'computer debriefing']","['technical skills', 'nontechnical skills, self-efficacy, and knowledge', 'higher ANTS scores', ""knowledge questionnaire on neonatal resuscitation, a self-efficacy rating, and expert evaluation of technical skills as per the Neonatal Resuscitation Performance Evaluation (NRPE) score and of nontechnical skills as per the Anaesthetists' Non-Technical Skills (ANTS) system"", 'higher self-efficacy ratings', 'Acquisition and Retention of Learning']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}]","[{'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",28.0,0.0274345,"Their scores remained higher, without statistical difference during session 2 (10 vs 7.75; P=.08).","[{'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Michelet', 'Affiliation': 'Ilumens Platform of Simulation in Healthcare, Université de Paris, Paris, France.'}, {'ForeName': 'Jessy', 'Initials': 'J', 'LastName': 'Barre', 'Affiliation': 'Ilumens Platform of Simulation in Healthcare, Université de Paris, Paris, France.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Truchot', 'Affiliation': 'Ilumens Platform of Simulation in Healthcare, Université de Paris, Paris, France.'}, {'ForeName': 'Marie-Aude', 'Initials': 'MA', 'LastName': 'Piot', 'Affiliation': 'Ilumens Platform of Simulation in Healthcare, Université de Paris, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Cabon', 'Affiliation': 'Ilumens Platform of Simulation in Healthcare, Université de Paris, Paris, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Tesniere', 'Affiliation': 'Ilumens Platform of Simulation in Healthcare, Université de Paris, Paris, France.'}]",JMIR serious games,['10.2196/18633']
2040,32780025,The Acceptability and Impact of the Xploro Digital Therapeutic Platform to Inform and Prepare Children for Planned Procedures in a Hospital: Before and After Evaluation Study.,"BACKGROUND


There is increasing interest in finding novel approaches to improve the preparation of children for hospital procedures such as surgery, x-rays, and blood tests. Well-prepared and informed children have better outcomes (less procedural anxiety and higher satisfaction). A digital therapeutic (DTx) platform (Xploro) was developed with children to provide health information through gamification, serious games, a chatbot, and an augmented reality avatar.
OBJECTIVE


This before and after evaluation study aims to assess the acceptability of the Xploro DTx and examine its impact on children and their parent's procedural knowledge, procedural anxiety, and reported experiences when attending a hospital for a planned procedure.
METHODS


We used a mixed methods design with quantitative measures and qualitative data collected sequentially from a group of children who received standard hospital information (before group) and a group of children who received the DTx intervention (after group). Participants were children aged between 8 and 14 years and their parents who attended a hospital for a planned clinical procedure at a children's hospital in North West England. Children and their parents completed self-report measures (perceived knowledge, procedural anxiety, procedural satisfaction, and procedural involvement) at baseline, preprocedure, and postprocedure.
RESULTS


A total of 80 children (n=40 standard care group and n=40 intervention group) and their parents participated in the study; the children were aged between 8 and 14 years (average 10.4, SD 2.27 years) and were attending a hospital for a range of procedures. The children in the intervention group reported significantly lower levels of procedural anxiety before the procedure than those in the standard group (two-tailed t 63.64 =2.740; P=.008). The children in the intervention group also felt more involved in their procedure than those in the standard group (t 75 =-2.238; P=.03). The children in the intervention group also reported significantly higher levels of perceived procedural knowledge preprocedure (t 59.98 =-4.892; P=.001) than those in the standard group. As for parents, those with access to the Xploro intervention reported significantly lower levels of procedural anxiety preprocedure than those who did not (t 68.51 =1.985; P=.05). During the semistructured write and tell interviews, children stated that they enjoyed using the intervention, it was fun and easy to use, and they felt that it had positively influenced their experiences of coming to the hospital for a procedure.
CONCLUSIONS


This study has shown that the DTx platform, Xploro, has a positive impact on children attending a hospital for a procedure by reducing levels of procedural anxiety. The children and parents in the intervention group described Xploro as improving their experiences and being easy and fun to use.",2020,The children and parents in the intervention group described Xploro as improving their experiences and being easy and fun to use.,"['80 children (n=40 standard care group and n=40 intervention group) and their parents participated in the study; the children were aged between 8 and 14 years (average 10.4, SD 2.27 years) and were attending a hospital for a range of procedures', ""Participants were children aged between 8 and 14 years and their parents who attended a hospital for a planned clinical procedure at a children's hospital in North West England""]","['DTx intervention', 'standard hospital information', 'digital therapeutic (DTx) platform (Xploro']","['levels of procedural anxiety', 'procedural anxiety preprocedure', 'higher levels of perceived procedural knowledge preprocedure', 'self-report measures (perceived knowledge, procedural anxiety, procedural satisfaction, and procedural involvement) at baseline, preprocedure, and postprocedure']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0216817', 'cui_str': 'dendrotoxin K'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3854439', 'cui_str': 'Procedural anxiety'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",80.0,0.0501019,The children and parents in the intervention group described Xploro as improving their experiences and being easy and fun to use.,"[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Bray', 'Affiliation': 'Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, United Kingdom.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Sharpe', 'Affiliation': 'Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, United Kingdom.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Gichuru', 'Affiliation': 'Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, United Kingdom.'}, {'ForeName': 'Peter-Marc', 'Initials': 'PM', 'LastName': 'Fortune', 'Affiliation': ""Royal Manchester Children's Hospital, Manchester, United Kingdom.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Blake', 'Affiliation': 'Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, United Kingdom.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Appleton', 'Affiliation': 'Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, United Kingdom.'}]",Journal of medical Internet research,['10.2196/17367']
2041,32780096,"Computer-aided indirect bonding versus traditional direct bonding of orthodontic brackets: bonding time, immediate bonding failures, and cost-minimization. A randomized controlled trial.","INTRODUCTION


The primary aim of this randomized controlled trial was to compare the time for bracket bonding using either direct or computer-aided indirect bonding; a secondary aim was to assess immediate bracket debondings and cost minimization.
METHODS


Consecutive patients were randomly allocated to two groups (blocks of four, online-generated sequence) using a split-mouth design with a direct and a computer-aided indirect bonding method: group 1 (upper right and lower left quadrants: indirect bonding; upper left and lower right quadrants: direct bonding) or group 2 (opposite situation). The primary outcome was difference in time spent for bonding brackets. The secondary outcome was immediate bracket debondings (at the bonding appointment). Time for indirect bonding was recorded in two steps: digital bracket placement and clinical bonding procedure. Outcome assessment was blinded. Friedman's ANOVA test was used to assess differences in bonding time. Chi-square test was used to compare immediate debondings. A cost-minimization analysis was undertaken.
RESULTS


Thirty-seven patients were randomized to group 1 or 2. Ten patients were excluded: 15 patients were analyzed in group 1 and 12 in group 2. Clinical chair time for bonding half a mouth was significantly shorter for computer-aided indirect bonding (12 minutes 52 seconds) than for direct bonding (16 minutes 47 seconds) (P < 0.001). When adding the time for digital bracket placement, the total bonding time (28 minutes 14 seconds) was longer for indirect bonding than for direct bonding (P < 0.001). There was no single immediate debonding with the direct bonding method, while 14 brackets were lost with the indirect bonding method (5.1 per cent) (P = 0.0001). Cost-minimization analysis showed that computer-aided indirect bonding was more expensive than direct bonding.
CONCLUSIONS


The clinical chair time was significantly shorter for computer-aided indirect bonding than for direct bonding. However, the total bonding time for computer-aided indirect, including digital bracket placement, was longer than for direct bonding. There were significantly more immediate debondings with computer-aided indirect bonding than with direct bonding. Under these conditions, computer-aided indirect bonding was more expensive than direct bonding.
REGISTRATION


This trial was retrospectively registered on ClinicalTrials.gov (University of Aarhus Protocol Record 10101).
PROTOCOL


The protocol was not published before trial commencement.",2020,Clinical chair time for bonding half a mouth was significantly shorter for computer-aided indirect bonding (12 minutes 52 seconds) than for direct bonding (16 minutes 47 seconds),"['Thirty-seven patients', 'Consecutive patients']","['direct or computer-aided indirect bonding', 'split-mouth design with a direct and a computer-aided indirect bonding method: group 1 (upper right and lower left quadrants: indirect bonding; upper left and lower right quadrants: direct bonding) or group 2 (opposite situation']","['time spent for bonding brackets', 'clinical chair time', 'immediate bracket debondings', 'total bonding time']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0439737', 'cui_str': 'Left lower quadrant'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",37.0,0.088216,Clinical chair time for bonding half a mouth was significantly shorter for computer-aided indirect bonding (12 minutes 52 seconds) than for direct bonding (16 minutes 47 seconds),"[{'ForeName': 'Izabela', 'Initials': 'I', 'LastName': 'Czolgosz', 'Affiliation': 'Private Practice, Torun, Poland.'}, {'ForeName': 'Paolo M', 'Initials': 'PM', 'LastName': 'Cattaneo', 'Affiliation': 'Section of Orthodontics, Department of Dentistry and Oral Health, Aarhus University, Denmark.'}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Cornelis', 'Affiliation': 'Section of Orthodontics, Department of Dentistry and Oral Health, Aarhus University, Denmark.'}]",European journal of orthodontics,['10.1093/ejo/cjaa045']
2042,32780138,Effects of Liberal vs Restrictive Transfusion Thresholds on Survival and Neurocognitive Outcomes in Extremely Low-Birth-Weight Infants: The ETTNO Randomized Clinical Trial.,"Importance


Red blood cell transfusions are commonly administered to infants weighing less than 1000 g at birth. Evidence-based transfusion thresholds have not been established. Previous studies have suggested higher rates of cognitive impairment with restrictive transfusion thresholds.
Objective


To compare the effect of liberal vs restrictive red blood cell transfusion strategies on death or disability.
Design, Setting, and Participants


Randomized clinical trial conducted in 36 level III/IV neonatal intensive care units in Europe among 1013 infants with birth weights of 400 g to 999 g at less than 72 hours after birth; enrollment took place between July 14, 2011, and November 14, 2014, and follow-up was completed by January 15, 2018.
Interventions


Infants were randomly assigned to liberal (n = 492) or restrictive (n = 521) red blood cell transfusion thresholds based on infants' postnatal age and current health state.
Main Outcome and Measures


The primary outcome, measured at 24 months of corrected age, was death or disability, defined as any of cognitive deficit, cerebral palsy, or severe visual or hearing impairment. Secondary outcome measures included individual components of the primary outcome, complications of prematurity, and growth.
Results


Among 1013 patients randomized (median gestational age at birth, 26.3 [interquartile range {IQR}, 24.9-27.6] weeks; 509 [50.2%] females), 928 (91.6%) completed the trial. Among infants in the liberal vs restrictive transfusion thresholds groups, respectively, incidence of any transfusion was 400/492 (81.3%) vs 315/521 (60.5%); median volume transfused was 40 mL (IQR, 16-73 mL) vs 19 mL (IQR, 0-46 mL); and weekly mean hematocrit was 3 percentage points higher with liberal thresholds. Among infants in the liberal vs restrictive thresholds groups, the primary outcome occurred in 200/450 (44.4%) vs 205/478 (42.9%), respectively, for a difference of 1.6% (95% CI, -4.8% to 7.9%; P = .72). Death by 24 months occurred in 38/460 (8.3%) vs 44/491 (9.0%), for a difference of -0.7% (95% CI, -4.3% to 2.9%; P = .70), cognitive deficit was observed in 154/410 (37.6%) vs 148/430 (34.4%), for a difference of 3.2% (95% CI, -3.3% to 9.6%; P = .47), and cerebral palsy occurred in 18/419 (4.3%) vs 25/443 (5.6%), for a difference of -1.3% (95% CI, -4.2% to 1.5%; P = .37), in the liberal vs the restrictive thresholds groups, respectively. In the liberal vs restrictive thresholds groups, necrotizing enterocolitis requiring surgical intervention occurred in 20/492 (4.1%) vs 28/518 (5.4%); bronchopulmonary dysplasia occurred in 130/458 (28.4%) vs 126/485 (26.0%); and treatment for retinopathy of prematurity was required in 41/472 (8.7%) vs 38/492 (7.7%). Growth at follow-up was also not significantly different between groups.
Conclusions and Relevance


Among infants with birth weights of less than 1000 g, a strategy of liberal blood transfusions compared with restrictive transfusions did not reduce the likelihood of death or disability at 24 months of corrected age.
Trial Registration


ClinicalTrials.gov Identifier: NCT01393496.",2020,", a strategy of liberal blood transfusions compared with restrictive transfusions did not reduce the likelihood of death or disability at 24 months of corrected age.
","['infants weighing less than 1000 g at birth', 'infants with birth weights of less than 1000 g', '1013 patients randomized (median gestational age at birth, 26.3 [interquartile range {IQR}, 24.9-27.6] weeks; 509 [50.2%] females), 928 (91.6%) completed the trial', '36 level III/IV neonatal intensive care units in Europe among 1013 infants with birth weights of 400 g to 999 g at less than 72 hours after birth; enrollment took place between July 14, 2011, and November 14, 2014, and follow-up was completed by January 15, 2018', 'Extremely Low-Birth-Weight Infants']","[""liberal (n\u2009=\u2009492) or restrictive (n\u2009=\u2009521) red blood cell transfusion thresholds based on infants' postnatal age and current health state"", 'liberal vs restrictive red blood cell transfusion strategies', 'Liberal vs Restrictive Transfusion']","['likelihood of death or disability', 'Survival and Neurocognitive Outcomes', 'retinopathy of prematurity', 'death or disability', 'cognitive deficit', 'bronchopulmonary dysplasia', 'cerebral palsy', 'individual components of the primary outcome, complications of prematurity, and growth', 'mean hematocrit', 'necrotizing enterocolitis requiring surgical intervention', 'death or disability, defined as any of cognitive deficit, cerebral palsy, or severe visual or hearing impairment', 'incidence of any transfusion', 'Death']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0456129', 'cui_str': 'Length of gestation at birth'}, {'cui': 'C4517668', 'cui_str': '26.3'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441927', 'cui_str': 'Level III'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C5191069', 'cui_str': '999'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0456065', 'cui_str': 'Extremely low birth weight infant'}]","[{'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035344', 'cui_str': 'Retinopathy of prematurity'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1960452', 'cui_str': 'Complication of prematurity'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",1013.0,0.388986,", a strategy of liberal blood transfusions compared with restrictive transfusions did not reduce the likelihood of death or disability at 24 months of corrected age.
","[{'ForeName': 'Axel R', 'Initials': 'AR', 'LastName': 'Franz', 'Affiliation': ""Center for Pediatric Clinical Studies, University Children's Hospital Tübingen, Tübingen, Germany.""}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Engel', 'Affiliation': ""Center for Pediatric Clinical Studies, University Children's Hospital Tübingen, Tübingen, Germany.""}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Bassler', 'Affiliation': 'University Hospital Zurich, Department of Neonatology, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Rüdiger', 'Affiliation': 'Clinic for Pediatrics, Department for Neonatology and Pediatric Intensive Care Medicine, Medical Faculty, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Ulrich H', 'Initials': 'UH', 'LastName': 'Thome', 'Affiliation': ""Children's Hospital, Division of Neonatology, Department of Women and Children's Health, University of Leipzig, Leipzig, Germany.""}, {'ForeName': 'Rolf F', 'Initials': 'RF', 'LastName': 'Maier', 'Affiliation': ""Children's Hospital, University Hospital, Philipps University Marburg, Marburg, Germany.""}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Krägeloh-Mann', 'Affiliation': ""Department of Paediatric Neurology and Developmental Medicine, University Children's Hospital Tübingen, Tübingen, Germany.""}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Kron', 'Affiliation': 'Institute for Epidemiology and Medical Biometry, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Essers', 'Affiliation': 'University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bührer', 'Affiliation': 'Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Rellensmann', 'Affiliation': 'Pediatrics, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Rossi', 'Affiliation': 'Vivantes Klinikum Neukölln, Berlin, Germany.'}, {'ForeName': 'Hans-Jörg', 'Initials': 'HJ', 'LastName': 'Bittrich', 'Affiliation': 'Helios Klinikum Erfurt, Erfurt, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Roll', 'Affiliation': 'Vestische Kinder-und Jugendklinik Datteln, Universität Witten/Herdecke, Datteln, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Höhn', 'Affiliation': 'Neonatology and Pediatric Intensive Care, University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Ehrhardt', 'Affiliation': 'Department of General Pediatrics and Neonatology, Justus-Liebig-University Giessen, Giessen, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Avenarius', 'Affiliation': 'Pediatrics, University Hospital Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Hans Thorsten', 'Initials': 'HT', 'LastName': 'Körner', 'Affiliation': 'Neonatology, Klinikum Links der Weser, Bremen, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Stein', 'Affiliation': 'Department of Paediatrics I, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Horst', 'Initials': 'H', 'LastName': 'Buxmann', 'Affiliation': 'University Hospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Vochem', 'Affiliation': 'Olgahospital, Klinikum Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Poets', 'Affiliation': ""Neonatology, University Children's Hospital Tübingen, Tübingen, Germany.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.10690']
2043,32773975,Comparative evaluation of 2% turmeric extract with nanocarrier and 1% chlorhexidine gel as an adjunct to scaling and root planing in patients with chronic periodontitis: A pilot randomized controlled clinical trial.,"Context


Nanoparticles, owing to their smaller size, penetrate regions inaccessible to other delivery systems, such as periodontal pockets. Thus, the present study aimed to comparatively evaluate efficacy of 2% curcumin with nanocarrier and 1% chlorhexidine gel as a local drug delivery (LDD) in the treatment of periodontal pockets.
Materials and Methods


Forty-five chronic periodontitis patients with pocket depth 5-7 mm in two or more teeth were selected. Full-mouth scaling and root planing (SRP) was done for all patients followed by random allocation to the three treatment groups, namely SRP group (Group 1), 2% curcumin with nanogel (Group 2), and 1% chlorhexidine gel (Group 3). Clinical parameter assessment and microbiological analysis of subgingival plaque samples for  Aggregatibacter actinomycetemcomitans  (Aa),  Porphyromonas gingivalis  (Pg), and  Tannerella forsythia  (Tf) was done at baseline, 21 st  day, and 45 th  day.
Results


The results showed that when the two LDD agents were used as an adjunct to SRP in chronic periodontitis, there was an improvement in all clinical parameters. Evaluation of microbiological parameters also showed a significant reduction in Aa, Pg, and Tf levels. Comparison of 2% turmeric extract with a nanocarrier system with 1% chlorhexidine gel showed that both the agents had a comparable antibacterial effect on the three selected periodontopathic bacteria.
Conclusion


The present study showed that both the LDD agents showed an effective improvement of clinical and microbiologic parameters. 2% curcumin delivered with a nanocarrier system showed results comparable to chlorhexidine gel and hence shows promising future as an LDD agent in the treatment of periodontal pockets.",2020,"Evaluation of microbiological parameters also showed a significant reduction in Aa, Pg, and Tf levels.","['Materials and Methods\n\n\nForty-five chronic periodontitis patients with pocket depth 5-7 mm in two or more teeth were selected', 'patients with chronic periodontitis']","['chlorhexidine gel', '2% turmeric extract with nanocarrier and 1% chlorhexidine gel', 'curcumin with nanocarrier and 1% chlorhexidine gel', 'Full-mouth scaling and root planing (SRP']","['Aa, Pg, and Tf levels', 'effective improvement of clinical and microbiologic parameters']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0077524', 'cui_str': 'Turmeric extract'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",45.0,0.0314429,"Evaluation of microbiological parameters also showed a significant reduction in Aa, Pg, and Tf levels.","[{'ForeName': 'Sanjeela Rakshith', 'Initials': 'SR', 'LastName': 'Guru', 'Affiliation': 'Department of Periodontology, Vydehi Institute of Dental Sciences and Research Centre, Bengaluru, Karnataka, India.'}, {'ForeName': 'K Adithya', 'Initials': 'KA', 'LastName': 'Reddy', 'Affiliation': 'Department of Periodontology, Vydehi Institute of Dental Sciences and Research Centre, Bengaluru, Karnataka, India.'}, {'ForeName': 'Ravi J', 'Initials': 'RJ', 'LastName': 'Rao', 'Affiliation': 'Department of Periodontology, Bangalore Institute of Dental Science, Kalaburgi, Karnataka, India.'}, {'ForeName': 'Shyam', 'Initials': 'S', 'LastName': 'Padmanabhan', 'Affiliation': 'Department of Periodontology, Vydehi Institute of Dental Sciences and Research Centre, Bengaluru, Karnataka, India.'}, {'ForeName': 'Rakshith', 'Initials': 'R', 'LastName': 'Guru', 'Affiliation': 'Department of Prosthodontics, ESIC Dental College, Kalaburgi, Karnataka, India.'}, {'ForeName': 'T S', 'Initials': 'TS', 'LastName': 'Srinivasa', 'Affiliation': 'Department of Periodontology, ESIC Dental College, Kalaburgi, Karnataka, India.'}]",Journal of Indian Society of Periodontology,['10.4103/jisp.jisp_207_19']
2044,32773977,Effectiveness of diode laser and fluoride on dentin hypersensitivity treatment: A randomized single-blinded clinical trial.,"Background


This randomized single-blinded clinical trial aimed to evaluate the effectiveness of diode laser and fluoride in the treatment of dentin hypersensitivity (DH) due to gingival recession.
Materials and Methods


Twenty-eight individuals randomly distributed across three groups participated: 10 individuals who were treated with diode laser, nine who were treated with fluoride, and nine who received placebo. Pain was assessed with the Visual analog scale (VAS). Evaporative stimulus and tactile stimulus were evaluated with the verbal rating scale (VRS). VAS was applied shortly after, 6 h after, 12 h after, and 24 h after the single-session treatment for DH, whereas VRS was applied shortly after, 15 min and 7 days after the treatment. Participants' quality of life was assessed with the validated Brazilian version of the Dentine Hypersensitivity Experience Questionnaire assessing functional limitations, coping behaviors, emotional, and social impacts caused by DH. Descriptive statistics and the ANOVA test were used. Values of  P  < 0.05 were statistically significant.
Results


Diode laser significantly reduced the DH to the evaporative stimulus ( P  = 0.002). The application of fluoride did not change the degree of DH to evaporative and tactile stimuli ( P  > 0.05). The group of individuals who were treated with diode laser presented a higher reduction in DH (25.4%) when compared to the group of individuals treated with fluoride (17.1%), and the group of individuals among whom placebo had been used (2.9%). Descriptive analysis indicated that the items measuring the emotional and social impacts of DH were those with a more negative impact on the individuals.
Conclusion


Therapy with diode laser was more effective in reducing DH than therapy with fluoride.",2020,The application of fluoride did not change the degree of DH to evaporative and tactile stimuli ( P  > 0.05).,"['dentin hypersensitivity (DH', 'Materials and Methods\n\n\nTwenty-eight individuals randomly distributed across three groups participated: 10 individuals who were treated with diode laser, nine who were treated with']","['VAS', 'Diode laser', 'fluoride', 'diode laser', 'fluoride, and nine who received placebo', 'diode laser and fluoride', 'placebo']","['quality of life', 'DH', 'Evaporative stimulus and tactile stimulus', 'verbal rating scale (VRS', 'degree of DH to evaporative and tactile stimuli', 'Visual analog scale (VAS', 'Pain', 'emotional and social impacts of DH', 'validated Brazilian version of the Dentine Hypersensitivity Experience Questionnaire assessing functional limitations, coping behaviors, emotional, and social impacts caused by DH', 'dentin hypersensitivity treatment']","[{'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0162468', 'cui_str': 'Social Impact'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",28.0,0.0356719,The application of fluoride did not change the degree of DH to evaporative and tactile stimuli ( P  > 0.05).,"[{'ForeName': 'Érika Soares', 'Initials': 'ÉS', 'LastName': 'Pantuzzo', 'Affiliation': 'Department of Clinical, Pathology and Dental Surgery, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Fabiano Araújo', 'Initials': 'FA', 'LastName': 'Cunha', 'Affiliation': 'Department of Clinical, Pathology and Dental Surgery, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Lucas Guimarães', 'Initials': 'LG', 'LastName': 'Abreu', 'Affiliation': ""Department of Child's and Adolescent's Oral Health, Faculty of Dentistry, Federal University of Minas Gerais, Belo Horizonte, Brazil.""}, {'ForeName': 'Rafael Paschoal', 'Initials': 'RP', 'LastName': 'Esteves Lima', 'Affiliation': 'Department of Clinical, Pathology and Dental Surgery, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}]",Journal of Indian Society of Periodontology,['10.4103/jisp.jisp_478_19']
2045,32774071,Transarterial chemoembolization with hepatic arterial infusion chemotherapy plus S-1 for hepatocellular carcinoma.,"BACKGROUND


Transarterial chemoembolization (TACE) and hepatic arterial infusion chemotherapy (HAIC) have shown promising local benefits for advanced hepatocellular carcinoma (HCC). S-1, a composite preparation of a 5-fluorouracil prodrug, has proven to be a convenient oral chemotherapeutic agent with definite efficacy against advanced HCC.
AIM


To evaluate the efficacy and safety of TACE followed by HAIC with or without oral S-1 for treating advanced HCC.
METHODS


In this single-center, open-label, prospective, randomized controlled trial, 117 participants with advanced HCC were randomized to receive TACE followed by oxaliplatin-based HAIC either with (TACE/HAIC + S-1,  n  = 56) or without (TACE/HAIC,  n  = 61) oral S-1 between December 2013 and September 2017. Two participants were excluded from final analysis for withdrawing consent. The primary endpoint was progression-free survival (PFS) and secondary endpoints included overall survival (OS), objective response rate, disease control rate and safety.
RESULTS


In total, 115 participants (100 males and 15 females; mean age, 57.7 years ± 11.9) were analyzed. The median PFS and OS were 5.0 mo (0.4-58.6 mo) (95% confidence interval (CI): 3.82 to 6.18)  vs  4.4 mo (1.1-54.4 mo) (95%CI: 2.54 to 6.26;  P  = 0.585) and 8.4 mo (0.4-58.6 mo) (95%CI: 6.88 to 9.92)  vs  8.3 mo (1.4-54.4 m) (95%CI: 5.71 to 10.96;  P  = 0.985) in the TACE/HAIC + S-1 and TACE/HAIC groups, respectively. The objective response rate and disease control rate were 30.9%  vs  18.4% and 72.7%  vs  56.7% in the TACE/HAIC + S-1 and TACE/HAIC groups, respectively. Grade 3/4 adverse events had a similar frequency in both treatment groups.
CONCLUSION


No improvements in tumor response rates, PFS or OS were observed with the addition of S-1 to TACE/HAIC in advanced HCC. Both treatment regimens had a similar safety profile.",2020,"No improvements in tumor response rates, PFS or OS were observed with the addition of S-1 to TACE/HAIC in advanced HCC.","['advanced hepatocellular carcinoma (HCC', '117 participants with advanced HCC', '115 participants (100 males and 15 females; mean age, 57.7 years ± 11.9) were analyzed', 'hepatocellular carcinoma']","['TACE', 'TACE followed by oxaliplatin-based HAIC either with (TACE/HAIC + S-1,  n  = 56) or without (TACE/HAIC,  n  = 61) oral S-1', 'Transarterial chemoembolization (TACE) and hepatic arterial infusion chemotherapy (HAIC', '5-fluorouracil', 'Transarterial chemoembolization with hepatic arterial infusion chemotherapy plus S-1']","['overall survival (OS), objective response rate, disease control rate and safety', 'efficacy and safety', 'tumor response rates, PFS or OS', 'objective response rate and disease control rate', 'median PFS and OS', 'progression-free survival (PFS', 'Grade 3/4 adverse events']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4304118', 'cui_str': 'Hepatic arterial infusion chemotherapy'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",117.0,0.181888,"No improvements in tumor response rates, PFS or OS were observed with the addition of S-1 to TACE/HAIC in advanced HCC.","[{'ForeName': 'Jian-Hai', 'Initials': 'JH', 'LastName': 'Guo', 'Affiliation': 'Department of Interventional Therapy, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing 100142, China.'}, {'ForeName': 'Shao-Xing', 'Initials': 'SX', 'LastName': 'Liu', 'Affiliation': 'Department of Interventional Therapy, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing 100142, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Department of Interventional Therapy, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing 100142, China.'}, {'ForeName': 'Fu-Xin', 'Initials': 'FX', 'LastName': 'Kou', 'Affiliation': 'Department of Interventional Therapy, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing 100142, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Interventional Therapy, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing 100142, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Interventional Therapy, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing 100142, China.'}, {'ForeName': 'Xiao-Ting', 'Initials': 'XT', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing 100142, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Interventional Therapy, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing 100142, China.'}, {'ForeName': 'Xiao-Dong', 'Initials': 'XD', 'LastName': 'Wang', 'Affiliation': 'Department of Interventional Therapy, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing 100142, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Department of Interventional Therapy, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing 100142, China.'}, {'ForeName': 'Peng-Jun', 'Initials': 'PJ', 'LastName': 'Zhang', 'Affiliation': 'Department of Interventional Therapy, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing 100142, China.'}, {'ForeName': 'Hai-Feng', 'Initials': 'HF', 'LastName': 'Xu', 'Affiliation': 'Department of Interventional Therapy, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing 100142, China.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Cao', 'Affiliation': 'Department of Interventional Therapy, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing 100142, China.'}, {'ForeName': 'Lin-Zhong', 'Initials': 'LZ', 'LastName': 'Zhu', 'Affiliation': 'Department of Interventional Therapy, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing 100142, China.'}, {'ForeName': 'Ren-Jie', 'Initials': 'RJ', 'LastName': 'Yang', 'Affiliation': 'Department of Interventional Therapy, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing 100142, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Interventional Therapy, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing 100142, China. drzhuxu@163.com.'}]",World journal of gastroenterology,['10.3748/wjg.v26.i27.3975']
2046,32774074,A Service Development Evaluation of Retrospective Data Exploring Prophylactic Risk-Reducing Advice for Patients with Gynecological Cancers.,"Objective:  Patients at risk of lymphedema following pelvic lymph-node dissection for gynecologic cancers (PLND) often receive prophylactic risk-reducing advice and compression stockings to wear for 6 months, without clear supportive evidence or evaluation of the impact. This study explored if these measures affected lymphedema development 1 year after PLND.  Materials and Methods:  Relevant data of patients who had undergone PLND over a 10-year period were allocated into 2 groups: Group A had data on patients who received prophylactic lymphedema risk-reduction advice and compression stockings for to wear for 6 months. Group B had data on patients who did not receive prophylactic lymphedema risk-reduction advice or prophylactic compression stockings. Exclusion criteria were preexisting swelling, medication that increased edema, symptom management during end-of-life care. Data were analyzed for statistical significance between the groups.  Results:  Of 108 patients, 19/60 patients (35%) in Group A and 6/48 (12.5%) patients in Group B developed lymphedema. There was no statistical difference between the groups for the presence of lymphedema.  Conclusions:  This study did not show that prophylactic compression stockings reduced the development of lymphedema but suggested an increased awareness of the signs and symptoms of lymphedema among patients who received risk-reducing education and the compression garments. These results should be tested in a prospective, controlled trial, and suggest that a change in current clinical practice is appropriate. (J GYNECOL SURG 36:198).",2020,This study did not show that prophylactic compression stockings reduced the development of lymphedema but suggested an increased awareness of the signs and symptoms of lymphedema among patients who received risk-reducing education and the compression garments.,"['Patients with Gynecological Cancers', 'Patients at risk of lymphedema following pelvic lymph-node dissection for gynecologic cancers (PLND', 'patients who had undergone PLND over a 10-year period were allocated into 2 groups']","['prophylactic compression stockings', 'prophylactic risk-reducing advice and compression stockings', 'Prophylactic Risk-Reducing Advice', 'prophylactic lymphedema risk-reduction advice and compression stockings']","['lymphedema', 'awareness of the signs and symptoms of lymphedema']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C3696989', 'cui_str': 'At risk of lymphedema'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0038348', 'cui_str': 'Compression stocking'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]","[{'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}]",108.0,0.0512821,This study did not show that prophylactic compression stockings reduced the development of lymphedema but suggested an increased awareness of the signs and symptoms of lymphedema among patients who received risk-reducing education and the compression garments.,"[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Woods', 'Affiliation': 'Lymphoedema Service, The Royal Marsden National Health Service Foundation Trust, Chelsea, London, United Kingdom.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Ruddell', 'Affiliation': 'Lymphoedema Service, The Royal Marsden National Health Service Foundation Trust, Chelsea, London, United Kingdom.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Sandsund', 'Affiliation': 'Lymphoedema Service, The Royal Marsden National Health Service Foundation Trust, Chelsea, London, United Kingdom.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'Lymphoedema Service, The Royal Marsden National Health Service Foundation Trust, Chelsea, London, United Kingdom.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Shaw', 'Affiliation': 'Lymphoedema Service, The Royal Marsden National Health Service Foundation Trust, Chelsea, London, United Kingdom.'}]",Journal of gynecologic surgery,['10.1089/gyn.2020.0008']
2047,32772873,Intranasal Ketamine as an Adjunct to Fentanyl for the Prehospital Treatment of Acute Traumatic Pain: Design and Rationale of a Randomized Controlled Trial.,"OBJECTIVE


Acute pain management is fundamental in prehospital trauma care. Early pain control may decrease the risk of developing post-traumatic stress disorder (PTSD) and chronic pain. Fentanyl and ketamine are frequently used off-label, but there is a paucity of comparative data to guide decision-making about treatment of prehospital severe, acute pain. This trial will determine whether the addition of single dose of intranasal ketamine to fentanyl is more effective for the treatment of acute traumatic pain than administration of fentanyl alone.
METHODS


This two-part study consists of prehospital and 90-day follow-up components (NCT02866071). The prehospital trial is a blinded, randomized, controlled trial of adult men (age 18-65 years) rating pain ≥7/10 after an acute traumatic injury of any type. Women will be excluded due to inability to confirm pregnancy status and unknown fetal risk. Paramedics will screen patients receiving standard of care fentanyl and, after obtaining standard informed consent, administer 50 mg intranasal ketamine or matching volume saline as placebo. Upon emergency department (ED) arrival, research associates will serially assess pain, concomitant treatments, and adverse side effects. Enrolled subjects will be approached for consent to participate in the 90-day follow-up study to determine rates of PTSD and chronic pain development. The primary outcome of the prehospital study is reduction in pain on the Verbal Numerical Rating Scale between baseline and 30-minutes after study drug administration. The proportion achieving a reduction of ≥2-points will be compared between study arms using a Chi-square test. Secondary outcomes of the prehospital trial include reduction in reported pain at the time of ED arrival and at 30 minutes intervals for up to three hours of ED care, the incidence of adverse events, and additional opiate requirements prior to ED arrival and within the first three hours of ED care. The outcomes in the follow-up study are satisfaction with life and development of PTSD or chronic pain at 90 days after injury. An intention-to-treat approach will be used.
CONCLUSION


These studies will test the hypotheses that ketamine plus fentanyl, when compared to fentanyl alone, effectively manages pain, decreases opiate requirements, and decreases PTSD at 90 days.",2020,The outcomes in the follow-up study are satisfaction with life and development of PTSD or chronic pain at 90 days after injury.,"['adult men (age 18-65 years) rating pain ≥7/10 after an acute traumatic injury of any type', 'Acute Traumatic Pain']","['Fentanyl and ketamine', 'ketamine plus fentanyl', 'Fentanyl', 'Intranasal Ketamine', 'ketamine or matching volume saline as placebo', 'intranasal ketamine']","['acute traumatic pain', 'reported pain at the time of ED arrival and at 30\u2009minutes intervals for up to three hours of ED care, the incidence of adverse events, and additional opiate requirements prior to ED arrival and within the first three hours of ED care', 'satisfaction with life and development of PTSD or chronic pain', 'pain on the Verbal Numerical Rating Scale', 'risk of developing post-traumatic stress disorder (PTSD) and chronic pain', 'rates of PTSD and chronic pain development']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.232566,The outcomes in the follow-up study are satisfaction with life and development of PTSD or chronic pain at 90 days after injury.,"[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'McMullan', 'Affiliation': 'University of Cincinnati, Department of Emergency Medicine.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Droege', 'Affiliation': 'UC Health - University of Cincinnati Medical Center, Department of Pharmacy.'}, {'ForeName': 'Col Richard', 'Initials': 'CR', 'LastName': 'Strilka', 'Affiliation': 'United States Air Force and University of Cincinnati, Department of Surgery.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Hart', 'Affiliation': 'Vanderbilt University, Department of Biostatistics.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lindsell', 'Affiliation': 'Vanderbilt University, Department of Biostatistics.'}]",Prehospital emergency care : official journal of the National Association of EMS Physicians and the National Association of State EMS Directors,['10.1080/10903127.2020.1808746']
2048,32772921,Impact of intermittent preventive treatment of malaria in pregnancy with dihydroartemisinin-piperaquine versus sulfadoxine-pyrimethamine on the incidence of malaria in infancy: a randomized controlled trial.,"BACKGROUND


Intermittent preventive treatment of malaria during pregnancy (IPTp) with dihydroartemisinin-piperaquine (DP) significantly reduces the burden of malaria during pregnancy compared to sulfadoxine-pyrimethamine (SP), the current standard of care, but its impact on the incidence of malaria during infancy is unknown.
METHODS


We conducted a double-blind randomized trial to compare the incidence of malaria during infancy among infants born to HIV-uninfected pregnant women who were randomized to monthly IPTp with either DP or SP. Infants were followed for all their medical care in a dedicated study clinic, and routine assessments were conducted every 4 weeks. At all visits, infants with fever and a positive thick blood smear were diagnosed and treated for malaria. The primary outcome was malaria incidence during the first 12 months of life. All analyses were done by modified intention to treat.
RESULTS


Of the 782 women enrolled, 687 were followed through delivery from December 9, 2016, to December 5, 2017, resulting in 678 live births: 339 born to mothers randomized to SP and 339 born to those randomized to DP. Of these, 581 infants (85.7%) were followed up to 12 months of age. Overall, the incidence of malaria was lower among infants born to mothers randomized to DP compared to SP, but the difference was not statistically significant (1.71 vs 1.98 episodes per person-year, incidence rate ratio (IRR) 0.87, 95% confidence interval (CI) 0.73-1.03, p = 0.11). Stratifying by infant sex, IPTp with DP was associated with a lower incidence of malaria among male infants (IRR 0.75, 95% CI 0.58-0.98, p = 0.03) but not female infants (IRR 0.99, 95% CI 0.79-1.24, p = 0.93).
CONCLUSION


Despite the superiority of DP for IPTp, there was no evidence of a difference in malaria incidence during infancy in infants born to mothers who received DP compared to those born to mothers who received SP. Only male infants appeared to benefit from IPTp-DP suggesting that IPTp-DP may provide additional benefits beyond birth. Further research is needed to further explore the benefits of DP versus SP for IPTp on the health outcomes of infants.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02793622 . Registered on June 8, 2016.",2020,"Overall, the incidence of malaria was lower among infants born to mothers randomized to DP compared to SP, but the difference was not statistically significant (1.71 vs 1.98 episodes per person-year, incidence rate ratio (IRR) 0.87, 95% confidence interval (CI) 0.73-1.03, p = 0.11).","['Only male infants', '581 infants (85.7%) were followed up to 12\u2009months of age', ' 687 were followed through delivery from December 9, 2016, to December 5, 2017, resulting in 678 live births: 339 born to mothers randomized to SP and 339 born to those randomized to', 'infants', 'malaria in infancy', 'infants born to HIV-uninfected pregnant women', '782 women enrolled', 'malaria in pregnancy with dihydroartemisinin-piperaquine versus']","['sulfadoxine-pyrimethamine (SP', 'DP for IPTp', 'sulfadoxine-pyrimethamine', 'IPTp with either DP or SP', 'DP', 'dihydroartemisinin-piperaquine (DP']","['incidence of malaria', 'malaria incidence', 'malaria incidence during the first 12\u2009months of life']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0700599', 'cui_str': 'Pyrimethamine- and sulfadoxine-containing product'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0747820', 'cui_str': 'Malaria, antepartum'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}]","[{'cui': 'C0700599', 'cui_str': 'Pyrimethamine- and sulfadoxine-containing product'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",782.0,0.276509,"Overall, the incidence of malaria was lower among infants born to mothers randomized to DP compared to SP, but the difference was not statistically significant (1.71 vs 1.98 episodes per person-year, incidence rate ratio (IRR) 0.87, 95% confidence interval (CI) 0.73-1.03, p = 0.11).","[{'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'Kakuru', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK. akakuru@idrc-uganda.org.'}, {'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Jagannathan', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kajubi', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Teddy', 'Initials': 'T', 'LastName': 'Ochieng', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Ochokoru', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Nakalembe', 'Affiliation': 'Department of Obstetrics and Gynaecology, Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Tamara D', 'Initials': 'TD', 'LastName': 'Clark', 'Affiliation': 'Department of Medicine, University of California, San Francisco, USA.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Ruel', 'Affiliation': 'Department of Paediatrics, University of California, San Francisco, USA.'}, {'ForeName': 'Sarah G', 'Initials': 'SG', 'LastName': 'Staedke', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Chandramohan', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Diane V', 'Initials': 'DV', 'LastName': 'Havlir', 'Affiliation': 'Department of Medicine, University of California, San Francisco, USA.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Dorsey', 'Affiliation': 'Department of Medicine, University of California, San Francisco, USA.'}]",BMC medicine,['10.1186/s12916-020-01675-x']
2049,32773013,"Active monitoring, radical prostatectomy and radical radiotherapy in PSA-detected clinically localised prostate cancer: the ProtecT three-arm RCT.","BACKGROUND


Prostate cancer is the most common cancer among men in the UK. Prostate-specific antigen testing followed by biopsy leads to overdetection, overtreatment as well as undertreatment of the disease. Evidence of treatment effectiveness has lacked because of the paucity of randomised controlled trials comparing conventional treatments.
OBJECTIVES


To evaluate the effectiveness of conventional treatments for localised prostate cancer (active monitoring, radical prostatectomy and radical radiotherapy) in men aged 50-69 years.
DESIGN


A prospective, multicentre prostate-specific antigen testing programme followed by a randomised trial of treatment, with a comprehensive cohort follow-up.
SETTING


Prostate-specific antigen testing in primary care and treatment in nine urology departments in the UK.
PARTICIPANTS


Between 2001 and 2009, 228,966 men aged 50-69 years received an invitation to attend an appointment for information about the Prostate testing for cancer and Treatment (ProtecT) study and a prostate-specific antigen test; 82,429 men were tested, 2664 were diagnosed with localised prostate cancer, 1643 agreed to randomisation to active monitoring ( n  = 545), radical prostatectomy ( n  = 553) or radical radiotherapy ( n  = 545) and 997 chose a treatment.
INTERVENTIONS


The interventions were active monitoring, radical prostatectomy and radical radiotherapy.
TRIAL PRIMARY OUTCOME MEASURE


Definite or probable disease-specific mortality at the 10-year median follow-up in randomised participants.
SECONDARY OUTCOME MEASURES


Overall mortality, metastases, disease progression, treatment complications, resource utilisation and patient-reported outcomes.
RESULTS


There were no statistically significant differences between the groups for 17 prostate cancer-specific ( p  = 0.48) and 169 all-cause ( p  = 0.87) deaths. Eight men died of prostate cancer in the active monitoring group (1.5 per 1000 person-years, 95% confidence interval 0.7 to 3.0); five died of prostate cancer in the radical prostatectomy group (0.9 per 1000 person-years, 95% confidence interval 0.4 to 2.2 per 1000 person years) and four died of prostate cancer in the radical radiotherapy group (0.7 per 1000 person-years, 95% confidence interval 0.3 to 2.0 per 1000 person years). More men developed metastases in the active monitoring group than in the radical prostatectomy and radical radiotherapy groups: active monitoring,  n  = 33 (6.3 per 1000 person-years, 95% confidence interval 4.5 to 8.8); radical prostatectomy,  n  = 13 (2.4 per 1000 person-years, 95% confidence interval 1.4 to 4.2 per 1000 person years); and radical radiotherapy,  n  = 16 (3.0 per 1000 person-years, 95% confidence interval 1.9 to 4.9 per 1000 person-years;  p  = 0.004). There were higher rates of disease progression in the active monitoring group than in the radical prostatectomy and radical radiotherapy groups: active monitoring ( n  = 112; 22.9 per 1000 person-years, 95% confidence interval 19.0 to 27.5 per 1000 person years); radical prostatectomy ( n  = 46; 8.9 per 1000 person-years, 95% confidence interval 6.7 to 11.9 per 1000 person-years); and radical radiotherapy ( n  = 46; 9.0 per 1000 person-years, 95% confidence interval 6.7 to 12.0 per 1000 person years;  p  < 0.001). Radical prostatectomy had the greatest impact on sexual function/urinary continence and remained worse than radical radiotherapy and active monitoring. Radical radiotherapy's impact on sexual function was greatest at 6 months, but recovered somewhat in the majority of participants. Sexual and urinary function gradually declined in the active monitoring group. Bowel function was worse with radical radiotherapy at 6 months, but it recovered with the exception of bloody stools. Urinary voiding and nocturia worsened in the radical radiotherapy group at 6 months but recovered. Condition-specific quality-of-life effects mirrored functional changes. No differences in anxiety/depression or generic or cancer-related quality of life were found. At the National Institute for Health and Care Excellence threshold of £20,000 per quality-adjusted life-year, the probabilities that each arm was the most cost-effective option were 58% (radical radiotherapy), 32% (active monitoring) and 10% (radical prostatectomy).
LIMITATIONS


A single prostate-specific antigen test and transrectal ultrasound biopsies were used. There were very few non-white men in the trial. The majority of men had low- and intermediate-risk disease. Longer follow-up is needed.
CONCLUSIONS


At a median follow-up point of 10 years, prostate cancer-specific mortality was low, irrespective of the assigned treatment. Radical prostatectomy and radical radiotherapy reduced disease progression and metastases, but with side effects. Further work is needed to follow up participants at a median of 15 years.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN20141297.
FUNDING


This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 37. See the National Institute for Health Research Journals Library website for further project information.",2020,"There were higher rates of disease progression in the active monitoring group than in the radical prostatectomy and radical radiotherapy groups: active monitoring ( n  = 112; 22.9 per 1000 person-years, 95% confidence interval 19.0 to 27.5 per 1000 person years); radical prostatectomy ( n  = 46; 8.9 per 1000 person-years, 95% confidence interval 6.7 to 11.9 per 1000 person-years); and radical radiotherapy ( n  = 46; 9.0 per 1000 person-years, 95% confidence interval 6.7 to 12.0 per 1000 person years;  p  < 0.001).","['Between 2001 and 2009, 228,966 men aged 50-69 years received an', 'men in the UK', ' n \u2009=\u2009545) and 997 chose a treatment', 'PSA-detected clinically localised prostate cancer', '82,429 men were tested, 2664 were diagnosed with localised prostate cancer, 1643 agreed to randomisation to active monitoring ( n \u2009=\u2009545', 'Prostate-specific antigen testing in primary care and treatment in nine urology departments in the UK', 'men aged 50-69 years']","['invitation to attend an appointment for information about the Prostate testing for cancer and Treatment (ProtecT) study and a prostate-specific antigen test', 'conventional treatments', 'radical prostatectomy and radical radiotherapy', 'localised prostate cancer (active monitoring, radical prostatectomy and radical radiotherapy', 'Active monitoring, radical prostatectomy and radical radiotherapy', 'Radical radiotherapy', 'radical prostatectomy ( n \u2009=\u2009553) or radical radiotherapy', 'Radical prostatectomy', 'Radical prostatectomy and radical radiotherapy', 'radical radiotherapy']","['17 prostate cancer-specific', 'Definite or probable disease-specific mortality', 'died of prostate cancer', 'Overall mortality, metastases, disease progression, treatment complications, resource utilisation and patient-reported outcomes', 'Sexual and urinary function', 'rates of disease progression', 'Bowel function', 'sexual function', 'anxiety/depression or generic or cancer-related quality of life', 'disease progression and metastases', 'Urinary voiding and nocturia', 'sexual function/urinary continence', 'prostate cancer-specific mortality']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517809', 'cui_str': '545'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C1531698', 'cui_str': 'Active monitoring'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0587531', 'cui_str': 'Urology department'}]","[{'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C1531698', 'cui_str': 'Active monitoring'}]","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C0542565', 'cui_str': 'Bladder control'}]",228966.0,0.168612,"There were higher rates of disease progression in the active monitoring group than in the radical prostatectomy and radical radiotherapy groups: active monitoring ( n  = 112; 22.9 per 1000 person-years, 95% confidence interval 19.0 to 27.5 per 1000 person years); radical prostatectomy ( n  = 46; 8.9 per 1000 person-years, 95% confidence interval 6.7 to 11.9 per 1000 person-years); and radical radiotherapy ( n  = 46; 9.0 per 1000 person-years, 95% confidence interval 6.7 to 12.0 per 1000 person years;  p  < 0.001).","[{'ForeName': 'Freddie C', 'Initials': 'FC', 'LastName': 'Hamdy', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Mason', 'Affiliation': 'School of Medicine, University of Cardiff, Cardiff, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Holding', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Wade', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Noble', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Garfield', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Young', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davis', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Peters', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Martin', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Oxley', 'Affiliation': 'Department of Cellular Pathology, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Robinson', 'Affiliation': 'Department of Cellular Pathology, Royal Victoria Infirmary, Newcastle upon Tyne, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Staffurth', 'Affiliation': 'Division of Cancer and Genetics, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Walsh', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Blazeby', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bryant', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Prasad', 'Initials': 'P', 'LastName': 'Bollina', 'Affiliation': 'Department of Urology and Surgery, Western General Hospital, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Catto', 'Affiliation': 'Academic Urology Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Doble', 'Affiliation': ""Department of Urology, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Doherty', 'Affiliation': 'Department of Urology, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gillatt', 'Affiliation': 'Department of Urology, Southmead Hospital and Bristol Urological Institute, Bristol, UK.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Gnanapragasam', 'Affiliation': ""Department of Urology, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Hughes', 'Affiliation': 'Department of Urology, Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Kockelbergh', 'Affiliation': 'Department of Urology, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Kynaston', 'Affiliation': 'Department of Urology, Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Paul', 'Affiliation': 'Department of Urology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Paez', 'Affiliation': 'Department of Urology, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Powell', 'Affiliation': 'Department of Urology, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Prescott', 'Affiliation': 'Department of Urology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Rosario', 'Affiliation': 'Academic Urology Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Rowe', 'Affiliation': 'Department of Urology, Southmead Hospital and Bristol Urological Institute, Bristol, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Neal', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24370']
2050,32773150,When will I feel normal again? Trajectories and predictors of persistent symptoms and poor wellbeing after primary chemotherapy for ovarian cancer.,"OBJECTIVES


After treatment for ovarian cancer, women want to know when they will feel 'normal' again. Our objective was to document the proportions of women with high levels of physical and emotional symptoms at the end of treatment, determine if/when they return to normal and identify groups at risk of persistent symptoms/delayed recovery.
METHODS


Women in the OPAL (Ovarian cancer Prognosis And Lifestyle) study who received ≥3 cycles of first-line chemotherapy and completed patient-reported outcome (PRO) questionnaires on or < 6 weeks after completing chemotherapy (baseline) were included in this analysis (n = 527). PRO measures included anxiety, depression, insomnia, fatigue and wellbeing (quality-of-life) at baseline, 3, 6, 9 and 18 months post-baseline. Group-based trajectory models identified clusters of individuals who followed similar patterns. Logistic and Cox regression identified factors associated with persistent symptoms and delayed recovery, respectively.
RESULTS


At baseline, 57% of women reported moderate-to-severe fatigue, 22% anxiety, 20% depression, 14% clinical insomnia and 45% had quality-of-life scores significantly lower than the general population. Between 50 and 75% of individual PRO scores normalised within six months, with the exception of emotional wellbeing (42%), but approximately two-in-five women still had at least one persistently poor PRO at 18 months. Women with more severe symptoms at baseline, who were younger, or had a history of anxiety/depression were more likely to have persistent symptoms or delayed recovery.
CONCLUSIONS


Two-in-five women might never fully return to 'normal' after completing primary treatment for ovarian cancer. Those with risk factors should be triaged for early supportive interventions.",2020,"PRO measures included anxiety, depression, insomnia, fatigue and wellbeing (quality-of-life) at baseline, 3, 6, 9 and 18 months post-baseline.","['ovarian cancer', 'Women in the OPAL (Ovarian cancer Prognosis And Lifestyle) study who received ≥3\u202fcycles of first-line chemotherapy and completed patient-reported outcome (PRO) questionnaires on or\u202f<\u202f6\u202fweeks after completing chemotherapy (baseline) were included in this analysis (n\u202f=\u202f527']",[],"['emotional wellbeing', 'moderate-to-severe fatigue', 'anxiety, depression, insomnia, fatigue and wellbeing (quality-of-life', 'quality-of-life scores', 'individual PRO scores']","[{'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0084990', 'cui_str': 'VPDA protocol'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517805', 'cui_str': '527'}]",[],"[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]",,0.157661,"PRO measures included anxiety, depression, insomnia, fatigue and wellbeing (quality-of-life) at baseline, 3, 6, 9 and 18 months post-baseline.","[{'ForeName': 'Vanessa L', 'Initials': 'VL', 'LastName': 'Beesley', 'Affiliation': 'Gynaecological Cancers Group, QIMR Berghofer Medical Research Institute, Brisbane, Australia. Electronic address: Vanessa.Beesley@qimrberghofer.edu.au.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Webber', 'Affiliation': 'Department of Medical Oncology, Prince of Wales Hospital, Sydney, Australia; Prince of Wales Clinical School, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Nagle', 'Affiliation': 'Gynaecological Cancers Group, QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'DeFazio', 'Affiliation': 'The Westmead Institute for Medical Research, The University of Sydney, Sydney, Australia; Department of Gynaecological Oncology, Westmead Hospital, Sydney, Australia.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Obermair', 'Affiliation': ""Queensland Centre for Gynaecological Cancer, Royal Brisbane and Women's Hospital, Brisbane, Australia.""}, {'ForeName': 'Merran', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'No affiliation. Consumer representative.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Friedlander', 'Affiliation': 'Department of Medical Oncology, Prince of Wales Hospital, Sydney, Australia.'}, {'ForeName': 'Penelope M', 'Initials': 'PM', 'LastName': 'Webb', 'Affiliation': 'Gynaecological Cancers Group, QIMR Berghofer Medical Research Institute, Brisbane, Australia; School of Public Health, The University of Queensland, Brisbane, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gynecologic oncology,['10.1016/j.ygyno.2020.07.029']
2051,32773206,"Corrigendum to ""Can personalized treatment prediction improve the outcomes, compared with the group average approach, in a randomized trial? Developing and validating a multivariable prediction model in a pragmatic megatrial of acute treatment for major depression"". [Journal of Affective Disorders 274 (2020) 690-697].",,2020,,['Journal of Affective Disorders 274 (2020) 690-697'],[],[],"[{'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}]",[],[],,0.0306846,,"[{'ForeName': 'Toshi A', 'Initials': 'TA', 'LastName': 'Furukawa', 'Affiliation': 'Departments of Health Promotion and Human Behavior and of Clinical Epidemiology, Kyoto University Graduate School of Medicine / School of Public Health, Kyoto, Japan. Electronic address: furukawa@kuhp.kyoto-u.ac.jp.'}, {'ForeName': 'Thomas P A', 'Initials': 'TPA', 'LastName': 'Debray', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, UMC Utrecht, Utrecht University, The Netherlands. Electronic address: t.debray@umcutrecht.nl.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Akechi', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan. Electronic address: takechi@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Mitsuhiko', 'Initials': 'M', 'LastName': 'Yamada', 'Affiliation': 'Department of Neuropsychopharmacology, National Institute of Mental Health, National Center of Neurology and Psychiatry, Tokyo, Japan. Electronic address: mitsuhiko_yamada@ncnp.go.jp.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Aratama Kokorono Clinic, Nagoya, Japan. Electronic address: aratama8177@yahoo.co.jp.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Seo', 'Affiliation': 'Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland. Electronic address: swj8874@gmail.com.'}, {'ForeName': 'Orestis', 'Initials': 'O', 'LastName': 'Efthimiou', 'Affiliation': 'Institute of Social and Preventive Medicine, University of Bern, Switzerland. Electronic address: oremiou@gmail.com.'}]",Journal of affective disorders,['10.1016/j.jad.2020.07.018']
2052,32773383,An Employment Intervention Program (Work2Prevent) for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 1): Protocol for Determining Essential Intervention Components Using Qualitative Interviews and Focus Groups.,"BACKGROUND


HIV continues to have a disparate impact on young cisgender men who have sex with men (YMSM), young trans women (YTW), and gender-nonconforming (GNC) youth who are assigned male at birth. Outcomes are generally worse among youth of color. Experiences of discrimination and marginalization often limit educational attainment and may even more directly limit access to gainful employment. Though seemingly distal, these experiences influence young people's proximity to HIV risk by limiting their access to health care and potentially moving them toward sex work as a means of income as well as increased substance use. Work2Prevent (W2P) aims to achieve economic stability through employment as a structural-level intervention for preventing adolescent and young adult HIV infection. The study will pilot-test an effective, theoretically driven employment program (increased individual income and independence [iFOUR]), for HIV-positive adults, and adapt it to the needs of black and Latinx YMSM, YTW, and GNC youth aged 16 to 24 years who are vulnerable to HIV exposure.
OBJECTIVE


This paper aimed to describe the protocol for the exploratory phase of W2P. The purpose of this phase was to determine the essential components needed for a structural-level employment intervention aimed at increasing job-seeking self-efficacy and career readiness among black and Latinx YMSM, YTW, and GNC youth aged 16 to 24 years.
METHODS


The exploratory phase of the W2P study consisted of in-depth interviews and focus groups with members of the target community as well as brief interviews with lesbian, gay, bisexual, transgender, and queer (LGBTQ)-inclusive employers. The study team will conduct in-depth interviews with up to 12 YMSM and 12 YTW and GNC youth, up to 10 focus groups with a maximum of 40 YMSM and 40 YTW and GNC youth, and up to 40 brief interviews with LGBTQ-inclusive employers. Participants will be recruited through a community-based recruiter, passive recruitment in community spaces and on social media, and active recruitment by research staff in community spaces serving LGBTQ youth.
RESULTS


In-depth interviews were conducted with 21 participants, and 7 focus groups were conducted with 46 participants in total. In addition, 19 brief interviews with LGBTQ-inclusive employers were conducted. The analysis of the data is underway.
CONCLUSIONS


Preliminary findings from the formative phase of the study will be used to inform the tailoring and refinement of the iFOUR adult-based intervention into the youth-focused W2P intervention curriculum. Perspectives from YMSM, YTW, GNC youth, and LGBTQ-inclusive employers offer a multidimensional view of the barriers and facilitators to adolescent and young adult LGBTQ employment. This information is critical to the development of a culturally appropriate and relevant youth-focused intervention.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03313310; https://clinicaltrials.gov/ct2/show/NCT03313310.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/16384.",2020,Outcomes are generally worse among youth of color.,"['black and Latinx YMSM, YTW, and GNC youth aged 16 to 24 years', 'HIV-positive adults, and adapt it to the needs of black and Latinx YMSM, YTW, and GNC youth aged 16 to 24 years who are vulnerable to HIV exposure', 'Participants will be recruited through a community-based recruiter, passive recruitment in community spaces and on social media, and active recruitment by research staff in community spaces serving LGBTQ youth', 'In-depth interviews were conducted with 21 participants, and 7 focus groups were conducted with 46 participants in total', 'depth interviews with up to 12 YMSM and 12 YTW and GNC youth, up to 10 focus groups with a maximum of 40 YMSM and 40 YTW and GNC youth, and up to 40 brief interviews with LGBTQ-inclusive employers', 'Young Men', 'adolescent and young adult HIV infection', 'young cisgender men who have sex with men (YMSM), young trans women (YTW), and gender-nonconforming (GNC) youth who are assigned male at birth', 'Men and Transgender Youth of Color (Phase 1']",['Employment Intervention Program (Work2Prevent'],[],"[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0242659', 'cui_str': 'Female homosexual'}, {'cui': 'C0019898', 'cui_str': 'Queers'}, {'cui': 'C0005639', 'cui_str': 'Bisexuality'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1274022', 'cui_str': 'Employer'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}]","[{'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],46.0,0.0444406,Outcomes are generally worse among youth of color.,"[{'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Hill', 'Affiliation': 'Planned Parenthood Great Plains, Overland Park, KS, United States.'}, {'ForeName': 'Darnell N', 'Initials': 'DN', 'LastName': 'Motley', 'Affiliation': 'Center for Interdisciplinary Inquiry and Innovation in Sexual and Reproductive Health, Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL, United States.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Rosentel', 'Affiliation': 'Center for Interdisciplinary Inquiry and Innovation in Sexual and Reproductive Health, Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL, United States.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'VandeVusse', 'Affiliation': 'Guttmacher Institute, New York City, NY, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Garofalo', 'Affiliation': ""Division of Adolescent Medicine, Ann & Robert H Lurie Children's Hospital, Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Schneider', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL, United States.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Kuhns', 'Affiliation': ""Division of Adolescent Medicine, Ann & Robert H Lurie Children's Hospital, Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.""}, {'ForeName': 'Michele D', 'Initials': 'MD', 'LastName': 'Kipke', 'Affiliation': ""Division of Research on Children, Youth, and Families, Children's Hospital Los Angeles, Los Angeles, CA, United States.""}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Reisner', 'Affiliation': 'Fenway Health, The Fenway Institute, Boston, MA, United States.'}, {'ForeName': 'Betty M', 'Initials': 'BM', 'LastName': 'Rupp', 'Affiliation': 'Collaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sanchez', 'Affiliation': 'Collaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Micah', 'Initials': 'M', 'LastName': 'McCumber', 'Affiliation': 'Collaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Renshaw', 'Affiliation': 'Collaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Matthew Shane', 'Initials': 'MS', 'LastName': 'Loop', 'Affiliation': 'Collaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}]",JMIR research protocols,['10.2196/16384']
2053,32773447,"A Large, Open-Label, Phase 3 Safety Study of DaxibotulinumtoxinA for Injection in Glabellar Lines: A Focus on Safety From the SAKURA 3 Study.","BACKGROUND


SAKURA 3 was a Phase 3, open-label, repeat-dose safety study of DaxibotulinumtoxinA for Injection (DAXI); a component of the largest Phase 3 clinical development program of an aesthetic neuromodulator in glabellar lines.
OBJECTIVE


To evaluate the use of DAXI (40U) up to 3 treatments for moderate or severe glabellar lines.
METHODS


Eligible subjects rolled over from the placebo-controlled trials (n = 477) or were de novo (n = 2,214) and received 1 to 3 treatments over a maximum of 84 weeks. Safety and efficacy were evaluated at least every 4 weeks up to Week 36 (Treatments 1 and 2) and Week 12 (Treatment 3). Select subjects could be retreated after Week 12 if glabellar lines returned to baseline.
RESULTS


Safety results are reported for 2,691 subjects, of which 882 received a second treatment and 568 a third. Treatment-related adverse events (AEs) occurred in 17.8% of subjects, which were generally mild and resolved. No serious AEs were treatment-related. Eyelid ptosis occurred in 0.9% of treatments. Adverse events were consistent across treatments and no new safety signals were observed.
CONCLUSION


The safety of DAXI in this large open-label safety study confirms the findings from the pivotal Phase 3 trials, providing reassurance in its overall safety profile.",2020,"Treatment-related adverse events (AEs) occurred in 17.8% of subjects, which were generally mild and resolved.","['2,691 subjects, of which 882 received a second treatment and 568 a third', 'Glabellar Lines', 'Eligible subjects rolled over from the placebo-controlled trials (n = 477) or were de novo (n = 2,214', 'moderate or severe glabellar lines']","['DAXI', 'DaxibotulinumtoxinA', 'DAXI (40U']","['Safety and efficacy', 'Eyelid ptosis', 'Adverse events', 'adverse events (AEs']","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442019', 'cui_str': 'Glabellar'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0543436', 'cui_str': 'Does roll over'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005745', 'cui_str': 'Ptosis of eyelid'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0439586,"Treatment-related adverse events (AEs) occurred in 17.8% of subjects, which were generally mild and resolved.","[{'ForeName': 'Jeremy B', 'Initials': 'JB', 'LastName': 'Green', 'Affiliation': 'Skin Associates of South Florida, Coral Gables, Florida.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Mariwalla', 'Affiliation': 'Mariwalla Dermatology, West Islip, New York.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Coleman', 'Affiliation': 'Etre Cosmetic Dermatology and Laser Center, New Orleans, Louisiana.'}, {'ForeName': 'Glynis', 'Initials': 'G', 'LastName': 'Ablon', 'Affiliation': 'Ablon Skin Institute & Research Center, Manhattan Beach, California.'}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Weinkle', 'Affiliation': 'University of South Florida, Tampa and Private Practice, Bradenton, Florida.'}, {'ForeName': 'Conor J', 'Initials': 'CJ', 'LastName': 'Gallagher', 'Affiliation': 'Revance Therapeutics, Inc., Newark, California.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Vitarella', 'Affiliation': 'Revance Therapeutics, Inc., Newark, California.'}, {'ForeName': 'Roman G', 'Initials': 'RG', 'LastName': 'Rubio', 'Affiliation': 'Revance Therapeutics, Inc., Newark, California.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002463']
2054,32773484,The effect of universal testing and treatment on HIV stigma in 21 communities in Zambia and South Africa: results from a cluster randomised trial.,"OBJECTIVES


To assess the impact of a combination HIV prevention intervention including universal testing and treatment (UTT) on HIV stigma among people living with HIV, and among community members and health workers not living with HIV.
DESIGN


This HIV stigma study was nested in the HPTN 071 (PopART) trial, a three-arm cluster randomised trial conducted between 2013-2018 in 21 urban/peri-urban communities (12 in Zambia and 9 in South Africa).
METHODS


Using an adjusted two-stage cluster-level analysis, controlling for baseline imbalances, we compared multiple domains of stigma between the trial arms at 36 months. Different domains of stigma were measured among three cohorts recruited across all study communities: 4,178 randomly sampled adults aged 18-44 who were living with HIV, and 3,487 randomly sampled adults and 1,224 health workers who did not self-report living with HIV.
RESULTS


Prevalence of any stigma reported by people living with HIV at 36 months was 20.2% in arm A, 26.1% in arm B, and 19.1% in arm C (adjusted prevalence ratio, A vs C 1.01 95% CI 0.49-2.08, B vs C 1.34 95% CI 0.65-2.75). There were no significant differences between arms in any other measures of stigma across all three cohorts. All measures of stigma reduced over time (0.2% to 4.1% reduction between rounds) with most reductions statistically significant.
CONCLUSIONS


We found little evidence that UTT either increased or decreased HIV stigma measured among people living with HIV, or among community members or health workers not living with HIV. Stigma reduced over time, but slowly.ClinicalTrials.gov number, NCT01900977.",2020,"We found little evidence that UTT either increased or decreased HIV stigma measured among people living with HIV, or among community members or health workers not living with HIV.","['three cohorts recruited across all study communities: 4,178 randomly sampled adults aged 18-44 who were living with HIV, and 3,487 randomly sampled adults and 1,224 health workers who did not self-report living with HIV', '21 communities in Zambia and South Africa', 'This HIV stigma study was nested in the HPTN 071 (PopART) trial, a three-arm cluster randomised trial conducted between 2013-2018 in 21\u200aurban/peri-urban communities (12 in Zambia and 9 in South Africa', 'people living with HIV, and among community members and health workers not living with HIV']","['universal testing and treatment', 'combination HIV prevention intervention including universal testing and treatment (UTT']","['stigma', 'HIV stigma']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0680022', 'cui_str': 'Member of'}]","[{'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",4178.0,0.520195,"We found little evidence that UTT either increased or decreased HIV stigma measured among people living with HIV, or among community members or health workers not living with HIV.","[{'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Stangl', 'Affiliation': 'International Center for Research on Women, Washington, D.C., USA.'}, {'ForeName': 'Triantafyllos', 'Initials': 'T', 'LastName': 'Pliakas', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, U.K.'}, {'ForeName': 'Tila', 'Initials': 'T', 'LastName': 'Mainga', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Steinhaus', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Mubekapi-Musadaidzwa', 'Affiliation': 'Department of Infectious Disease, Imperial College, London, U.K.'}, {'ForeName': 'Lario', 'Initials': 'L', 'LastName': 'Viljoen', 'Affiliation': 'SCHARP, Seattle, Washington, US.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Dunbar', 'Affiliation': ''}, {'ForeName': 'Ab', 'Initials': 'A', 'LastName': 'Schaap', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Floyd', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, U.K.'}, {'ForeName': 'Nomtha', 'Initials': 'N', 'LastName': 'Mandla', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Bond', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, U.K.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Hoddinott', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fidler', 'Affiliation': 'Department of Infectious Disease, Imperial College, London, U.K.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hayes', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, U.K.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Ayles', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, U.K.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bock', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Donnell', 'Affiliation': 'SCHARP, Seattle, Washington, US.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Hargreaves', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, U.K.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000002658']
2055,32774549,Effects of Resisted Vs. Conventional Sprint Training on Physical Fitness in Young Elite Tennis Players.,"This study aimed to compare the effects of 6-week resisted sprint (RST) versus conventional (unresisted) sprint training (CG) on sprint time, change of direction (COD) speed, repeated sprint ability (RSA) and jump performance (countermovement jump (CMJ) and standing long jump (SLJ)) in male young tennis players. Twenty players (age: 16.5 ± 0.3 years; body mass: 72.2 ± 5.5 kg; body height: 180.6 ± 4.6 cm) were randomly assigned to one of the two groups: RST (n = 10) and CG (n = 10). The training program was similar for both groups consisting of acceleration and deceleration exercises at short distances (3-4 m), and speed and agility drills. The RST group used weighted vests or elastic cords during the exercises. After 6 weeks of intervention, both training regimes resulted in small-to-moderate improvements in acceleration and sprint ability (5, 10, 20 m), SLJ and CMJ performances, COD pivoting on both, the non-dominant (moderate effect) and the dominant (small effect) foot, and the percentage of decrement (small effects) during a RSA test. Between-group comparisons showed that the SLJ (Δ = 2.0%) and 5 m sprint time (Δ = 1.1%) improved more in the RST group compared with the CG group. This study showed that 6 weeks of RST or unresisted training are time-efficient training regimes for physical improvements in young male tennis players.",2020,"After 6 weeks of intervention, both training regimes resulted in small-to-moderate improvements in acceleration and sprint ability (5, 10, 20 m), SLJ and CMJ performances, COD pivoting on both, the non-dominant (moderate effect) and the dominant (small effect) foot, and the percentage of decrement (small effects) during a RSA test.","['Twenty players (age: 16.5 ± 0.3 years; body mass: 72.2 ± 5.5 kg; body height: 180.6 ± 4.6 cm', 'male young tennis players', 'Young Elite Tennis Players', 'young male tennis players']","['SLJ', 'Conventional Sprint Training', 'RST', '6-week resisted sprint (RST) versus conventional (unresisted) sprint training (CG']","['Physical Fitness', 'acceleration and sprint ability (5, 10, 20 m), SLJ and CMJ performances, COD pivoting on both, the non-dominant (moderate effect', 'sprint time, change of direction (COD) speed, repeated sprint ability (RSA) and jump performance (countermovement jump (CMJ) and standing long jump (SLJ', '5 m sprint time']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0039515', 'cui_str': 'Tennis'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0454374', 'cui_str': 'Sprint training'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205166', 'cui_str': 'Long'}]",,0.0196881,"After 6 weeks of intervention, both training regimes resulted in small-to-moderate improvements in acceleration and sprint ability (5, 10, 20 m), SLJ and CMJ performances, COD pivoting on both, the non-dominant (moderate effect) and the dominant (small effect) foot, and the percentage of decrement (small effects) during a RSA test.","[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Moya-Ramon', 'Affiliation': 'Department of Sports Sciences, Miguel Hernandez University, Elche, Spain.'}, {'ForeName': 'Fabio Yuzo', 'Initials': 'FY', 'LastName': 'Nakamura', 'Affiliation': 'Department of Medicine and Aging Sciences, ""G. d\'Annunzio"" University of Chieti-Pescara, Chieti, Italy.'}, {'ForeName': 'Anderson Santiago', 'Initials': 'AS', 'LastName': 'Teixeira', 'Affiliation': 'Physical Effort Laboratory, Sports Center, Federal University of Santa Catarina, Florianópolis - SC, Brazil.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Granacher', 'Affiliation': 'Division of Training and Movement Sciences, Research Focus Cognition Sciences, University of Potsdam, Potsdam, Germany.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Santos-Rosa', 'Affiliation': 'Faculty of Sport, Pablo de Olavide University, Seville, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sanz-Rivas', 'Affiliation': 'Spanish Tennis Federation, Madrid, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Fernandez-Fernandez', 'Affiliation': 'Spanish Tennis Federation, Madrid, Spain.'}]",Journal of human kinetics,['10.2478/hukin-2019-0142']
2056,32774553,"Effects of Training with an Agility Ladder on Sprint, Agility, and Dribbling Performance in Youth Soccer Players.","The aim of this study was to examine the effects of coordination training using an agility ladder compared with a control group on physical fitness and technical performance in youth soccer players. Eighteen male youth soccer players (age: 12.2 ± 0.4 years; body height: 158.3 ± 10.8 cm; body mass: 45.0 ± 8.0 kg) were randomly assigned to an agility ladder group (n = 10) or a control group (n = 8). The intervention program was carried out three times a week over six weeks. Before and after the training period, the 10 m sprint, 20 m sprint, dribbling speed test, agility test, and slalom dribbling test performances were assessed. Within-group analysis showed significant improvements (p < 0.005) in 10 m and 20 m sprint performance from the pre- to the post-test for the agility ladder group (-2.39% and -2.10%) and the control group (-2.54% and -1.44%). No significant differences (p > 0.005) were found from the pre- to the post-test in the dribbling speed test, agility test, slalom dribbling test, and skill index. In the between-group analysis, there were no differences between the agility ladder group and the control group in any variable. In conclusion, the findings of this study suggest coordination training with an agility ladder does not seem to be effective to improve physical fitness and dribbling. Therefore, this information could be beneficial to players and coaches for programming tasks during soccer training sessions.",2020,Within-group analysis showed significant improvements (p < 0.005) in 10 m and 20 m sprint performance from the pre- to the post-test for the agility ladder group (-2.39% and -2.10%) and the control group (-2.54% and -1.44%).,"['Youth Soccer Players', 'youth soccer players', 'Eighteen male youth soccer players (age: 12.2 ± 0.4 years; body height: 158.3 ± 10.8 cm; body mass: 45.0 ± 8.0 kg']","['Training with an Agility Ladder', 'agility ladder group', 'coordination training']","['physical fitness and technical performance', 'Sprint, Agility, and Dribbling Performance', 'dribbling speed test, agility test, slalom dribbling test, and skill index']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0336762', 'cui_str': 'Ladder'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0419112', 'cui_str': 'Coordination training'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0013132', 'cui_str': 'Dribbling from mouth'}, {'cui': 'C0449250', 'cui_str': 'Speed of test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",18.0,0.0194096,Within-group analysis showed significant improvements (p < 0.005) in 10 m and 20 m sprint performance from the pre- to the post-test for the agility ladder group (-2.39% and -2.10%) and the control group (-2.54% and -1.44%).,"[{'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Padrón-Cabo', 'Affiliation': 'Faculty of Education and Sport Sciences, University of Vigo, Pontevedra, Spain.'}, {'ForeName': 'Ezequiel', 'Initials': 'E', 'LastName': 'Rey', 'Affiliation': 'Faculty of Education and Sport Sciences, University of Vigo, Pontevedra, Spain.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Kalén', 'Affiliation': 'Faculty of Education and Sport Sciences, University of Vigo, Pontevedra, Spain.'}, {'ForeName': 'Pablo B', 'Initials': 'PB', 'LastName': 'Costa', 'Affiliation': 'Human Performance Laboratory, Center for Sport Performance, Department of Kinesiology, California State University, Fullerton, CA, USA.'}]",Journal of human kinetics,['10.2478/hukin-2019-0146']
2057,32774555,Effects of High-Velocity Strength Training on Movement Velocity and Strength Endurance in Experienced Powerlifters with Cerebral Palsy.,"The present study aimed to evaluate the effects of a 6-week high-velocity strength training (HVST) intervention on movement velocity and strength endurance in experienced powerlifters with cerebral palsy (CP). Eleven experienced powerlifters with CP and seven from a control group (CON), were subjected to 6-week HVST. An assessment of movement velocity and strength endurance was conducted one week before (T1) and one week after (T2) the 6-week training intervention. During testing, athletes performed a maximum number of bench press repetitions possible within 5 sets of 15 s each, with 1-min passive rest intervals in-between. The indicator of movement velocity was the weight pressed in the first 5 s (5sW) in all performed sets. Strength endurance was described by the total weight (TW) pressed during the test. 5sW in T2 was significantly higher as compared with T1 in the CP group only (T1 928.9 ± 342.9 kg vs. T2 1007.3 ± 324.6 kg; p = 0.016). TW in T2 was significantly higher as compared with T1, both in the CP group (T1 2550.5 ± 843.9 kg vs. T2 2809.8 ± 981.3 kg; p < 0.001) and in the CON group (T1 2300.7 ± 845.1 kg vs. T2 2468.9 ± 890.1 kg; p = 0.049). A 6-week program of HVST increased movement velocity in resistance trained CP athletes. The gains of strength endurance were observed in both groups.",2020,"TW in T2 was significantly higher as compared with T1, both in the CP group (T1 2550.5 ± 843.9 kg vs. T2 2809.8 ± 981.3 kg; p < 0.001) and in the CON group (T1 2300.7 ± 845.1 kg vs. T2 2468.9 ± 890.1 kg; p = 0.049).","['resistance trained CP athletes', 'Experienced Powerlifters with Cerebral Palsy', 'experienced powerlifters with cerebral palsy (CP']","['High-Velocity Strength Training', '6-week high-velocity strength training (HVST) intervention', 'HVST']","['movement velocity', 'Strength endurance', 'Movement Velocity and Strength Endurance', 'total weight (TW', 'gains of strength endurance', 'movement velocity and strength endurance']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",,0.0156251,"TW in T2 was significantly higher as compared with T1, both in the CP group (T1 2550.5 ± 843.9 kg vs. T2 2809.8 ± 981.3 kg; p < 0.001) and in the CON group (T1 2300.7 ± 845.1 kg vs. T2 2468.9 ± 890.1 kg; p = 0.049).","[{'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Szafraniec', 'Affiliation': 'Department of Paralympic Sports, University School of Physical Education in Wroclaw, Wroclaw, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Kisilewicz', 'Affiliation': 'Department of Paralympic Sports, University School of Physical Education in Wroclaw, Wroclaw, Poland.'}, {'ForeName': 'Martyna', 'Initials': 'M', 'LastName': 'Kumorek', 'Affiliation': 'Department of Paralympic Sports, University School of Physical Education in Wroclaw, Wroclaw, Poland.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Kristiansen', 'Affiliation': 'Sport Sciences - Performance and Technology, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Madeleine', 'Affiliation': 'Sport Sciences - Performance and Technology, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Mroczek', 'Affiliation': 'Department of Biological and Motor Sport Bases, University School of Physical Education in Wroclaw, Wroclaw, Poland.'}]",Journal of human kinetics,['10.2478/hukin-2020-0009']
2058,32774558,Mini-Basketball Training Program Improves Physical Fitness and Social Communication in Preschool Children with Autism Spectrum Disorders.,"This investigation examined the effects of a 12-week mini-basketball training program (MBTP) on physical fitness and social communication in preschool children with autism spectrum disorders (ASD). The study applied a quasi-experimental design. Fifty-nine preschool children aged 3-6 years with ASD were assigned to either a MBTP group (n = 30) or a control group (n = 29). Participants in the MBTP group received a scheduled mini-basketball training program (5 sessions per week, forty minutes per session) for twelve consecutive weeks, while the control group was instructed to maintain their daily activities. The physical fitness test and the parent-reported Social Responsiveness Scale Second Edition (SRS-2) test were performed before and after the intervention. Results indicated that the 12-week MBTP facilitated performance in the physical fitness test, particularly in speed-agility and muscular strength abilities. Additionally, children in the MBTP group demonstrated improvement in SRS-2 performance in social awareness, social cognition, social communication, and autistic mannerisms, whereas no such changes were found in the control group. It may be concluded that the 12-week MBTP could improve physical fitness and social communication in preschool children with ASD, and thus the use of physical exercise intervention as a therapeutic tool for preschoolers with ASD is recommended.",2020,"Results indicated that the 12-week MBTP facilitated performance in the physical fitness test, particularly in speed-agility and muscular strength abilities.","['preschool children with autism spectrum disorders (ASD', 'Fifty-nine preschool children aged 3-6 years with ASD', 'Preschool Children with Autism Spectrum Disorders', 'preschoolers with ASD', 'preschool children with ASD']","['Mini-Basketball Training Program', 'physical exercise intervention', 'MBTP', 'scheduled mini-basketball training program', 'mini-basketball training program (MBTP']","['Physical Fitness and Social Communication', 'physical fitness and social communication', 'SRS-2 performance in social awareness, social cognition, social communication, and autistic mannerisms', 'speed-agility and muscular strength abilities', 'physical fitness test and the parent-reported Social Responsiveness Scale Second Edition (SRS-2) test']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0233576', 'cui_str': 'Mannerism'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441795', 'cui_str': 'Second edition'}]",59.0,0.00800988,"Results indicated that the 12-week MBTP facilitated performance in the physical fitness test, particularly in speed-agility and muscular strength abilities.","[{'ForeName': 'Ke-Long', 'Initials': 'KL', 'LastName': 'Cai', 'Affiliation': 'College of Physical Education, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Jin-Gui', 'Initials': 'JG', 'LastName': 'Wang', 'Affiliation': 'College of Physical Education, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Zhi-Mei', 'Initials': 'ZM', 'LastName': 'Liu', 'Affiliation': 'College of Physical Education, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Li-Na', 'Initials': 'LN', 'LastName': 'Zhu', 'Affiliation': 'School of Physical Education and Sports Science, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Xiong', 'Affiliation': 'College of Physical Education, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Klich', 'Affiliation': 'Department of Paralympic Sport, University School of Physical Education in Wrocław, Wrocław, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Maszczyk', 'Affiliation': 'Institute of Sport Sciences, Academy of Physical Education in Katowice, Katowice, Poland.'}, {'ForeName': 'Ai-Guo', 'Initials': 'AG', 'LastName': 'Chen', 'Affiliation': 'College of Physical Education, Yangzhou University, Yangzhou, China.'}]",Journal of human kinetics,['10.2478/hukin-2020-0007']
2059,32774560,Does Oxygen Uptake Before Physical Exercise Affect Tear Osmolarity?,"Recently, it has been reported that tear osmolarity (Tosm) is correlated with plasma osmolarity and will increase during exertion. We aimed to assess whether inhaling oxygen-enriched air between exercises could significantly change the Tosm value. Thirty men aged 24.9 years were included in the study. A cycloergometer was used to perform the exercise protocol. We recorded the participants' Tosm (mOsm/L), heart rate (HR, beats/minute), oxygen saturation, and blood pressure values. After the first exhaustive exercise (T1), participants inhaled oxygen in the experimental group and a placebo in the control group. After the second exercise (T2), another set of measurements was obtained. The Tosm value before exercise was 297.4 ± 1.21 and 296.53 ± 1.11 mOsm/L (p = 0.61718) and the HR was 72.6 ± 2.59 and 73 ± 2.59 beats/minute (p = 0.39949) in the study and the control group, respectively. At T1, Tosm was 303.67 ± 1.25 and 302.2 ± 1.25 mOsm/L (p = 0.41286) and the HR reached 178.04 ± 2.60 and 176.4 ± 2.60 beats/minute (p = 0.65832), respectively. At T2, Tosm in the study group reached 305.73 ± 0.86 mOsm/L (correlation with the use of oxygen: r = -0.3818), and in the control group, it was 308.4 ± 0.86 mOsm/L (p = 0.0373), while the HR reached 172.20 ± 2.53 beats/minute in the study group and 178.2 ± 2.53 beats/minute in the control group (p = 0.057). It was concluded that inhaling oxygen before and after exercise could increase the rate of recovery after exhaustive exercise.",2020,"At T1, Tosm was 303.67 ± 1.25 and 302.2 ± 1.25 mOsm/L (p = 0.41286) and the HR reached 178.04 ± 2.60 and 176.4 ± 2.60 beats/minute (p = 0.65832), respectively.",['Thirty men aged 24.9 years were included in the study'],"['inhaling oxygen-enriched air between exercises', 'placebo']","['heart rate (HR, beats/minute), oxygen saturation, and blood pressure values', 'rate of recovery']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0567893,"At T1, Tosm was 303.67 ± 1.25 and 302.2 ± 1.25 mOsm/L (p = 0.41286) and the HR reached 178.04 ± 2.60 and 176.4 ± 2.60 beats/minute (p = 0.65832), respectively.","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Wylęgała', 'Affiliation': 'Ophthalmology Department, Railway Hospital, Katowice, Poland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Pilch', 'Affiliation': 'Chair of Physiological-Medical Sciences. The Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}, {'ForeName': 'Bartłomiej', 'Initials': 'B', 'LastName': 'Bolek', 'Affiliation': 'Ophthalmology Department, Railway Hospital, Katowice, Poland.'}, {'ForeName': 'Bogumiła', 'Initials': 'B', 'LastName': 'Sędziak-Marcinek', 'Affiliation': 'Ophthalmology Department, Railway Hospital, Katowice, Poland.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Wylęgała', 'Affiliation': 'Ophthalmology Department, Railway Hospital, Katowice, Poland.'}]",Journal of human kinetics,['10.2478/hukin-2019-0118']
2060,32774580,Erratum: Uncomplicated percutaneous IVC filter removal following implantation time of 6033 days.,[This corrects the article DOI: 10.1016/j.radcr.2020.05.008.].,2020,[This corrects the article DOI: 10.1016/j.radcr.2020.05.008.].,['Erratum'],[],[],[],[],[],,0.0303462,[This corrects the article DOI: 10.1016/j.radcr.2020.05.008.].,"[{'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Michell', 'Affiliation': 'Department of Radiology, Larner College of Medicine, University of Vermont Medical Center, 111 Colchester Ave., Burlingon, VT, USA.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Johnston', 'Affiliation': 'Department of Radiology, Larner College of Medicine, University of Vermont Medical Center, 111 Colchester Ave., Burlingon, VT, USA.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Morris', 'Affiliation': 'Department of Radiology, Larner College of Medicine, University of Vermont Medical Center, 111 Colchester Ave., Burlingon, VT, USA.'}]",Radiology case reports,['10.1016/j.radcr.2020.06.025']
2061,32774745,A novel reduction device for the minimally invasive treatment of femoral shaft fractures.,"OBJECTIVE


In this study, a new type of reduction device for femoral shaft fractures was developed and designed. The reduction procedure was also standardized and is expected to be useful in clinical practice.
METHODS


A bone traction retractor that consisted of a special traction needle, a resistant sleeve, a crossbar and an arc-adjusting bar was designed. Forty-eight patients (32 males and 16 females, mean age 33.21±7.03 years old) with femoral shaft fractures treated in our hospital from January 2016 to December 2017 were selected. According to the AO classification, there were 15 patients with type A, 24 patients with type B and 9 patients with type C fractures. All patients were treated with transverse bone traction for closed reduction of femoral shaft fractures and femoral reconstruction with intramedullary nails for final fixation. The injured side, preoperative delay time, reduction and operative times, operative blood loss, drilling frequency, number of open reduction cases, hospitalization days, fracture healing time, postoperative HSS function score and complications were recorded.
RESULTS


All 48 patients were treated with transverse bone traction using our novel device to obtain reduction. The average time needed for reduction was 19.98±4.66 min. The operating time was 60-100 min, with an average of 78.65±16.81 min, and the average intraoperative blood loss was 131.91±30.22 ml. Open reduction was performed in 8 patients: 1 patient in the experimental group and 7 patients in the control group. The average hospitalization days was 7.78±2.81 days, the fracture healing time was 10 to 15 weeks, with an average of 12.44±2.63 weeks, and the postoperative HSS score was 80-95 points, with an average of 86.52±6.03 points. None of the patients had coxa vara, nonunion, internal fixation failure, infection, nerve injury, limb length discrepancy or other complications.
CONCLUSION


In this study, the transverse bone traction reduction technique and the design of a proprietary reduction device system were proposed, with high clinical application. The transverse bone traction reduction technique has the advantages of simple operation, reliable reduction and limited intraoperative fluoroscopy in the minimally invasive treatment of femoral shaft fractures.",2020,"None of the patients had coxa vara, nonunion, internal fixation failure, infection, nerve injury, limb length discrepancy or other complications.
","['All 48 patients were treated with', 'femoral shaft fractures', 'Forty-eight patients (32 males and 16 females, mean age 33.21±7.03 years old) with femoral shaft fractures treated in our hospital from January 2016 to December 2017 were selected', '15 patients with type A, 24 patients with type B and 9 patients with type C fractures']","['transverse bone traction', 'special traction needle, a resistant sleeve, a crossbar and an arc-adjusting bar was designed', 'femoral shaft fractures and femoral reconstruction with intramedullary nails for final fixation']","['operating time', 'injured side, preoperative delay time, reduction and operative times, operative blood loss, drilling frequency, number of open reduction cases, hospitalization days, fracture healing time, postoperative HSS function score and complications', 'fracture healing time', 'average time needed for reduction', 'postoperative HSS score', 'average intraoperative blood loss', 'average hospitalization days', 'coxa vara, nonunion, internal fixation failure, infection, nerve injury, limb length discrepancy or other complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0272753', 'cui_str': 'Fracture of shaft of femur'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0272753', 'cui_str': 'Fracture of shaft of femur'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0522486', 'cui_str': 'Delay time'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0337279', 'cui_str': 'Drilling - action'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0152231', 'cui_str': 'Fracture, healed'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018522', 'cui_str': 'Hallermann-Streiff syndrome'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0152431', 'cui_str': 'Congenital coxa vara'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0161479', 'cui_str': 'Nerve injury'}, {'cui': 'C0410785', 'cui_str': 'Limb length discrepancy'}]",24.0,0.0125228,"None of the patients had coxa vara, nonunion, internal fixation failure, infection, nerve injury, limb length discrepancy or other complications.
","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': ""Department of Bone and Joint, Shenzhen People's Hospital, The First Affiliated Hospital of Nanfan University of Science and Technology, The Second Clinical Medical College of Jinan University Shenzhen 518020, Guangdong, P. R. China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""Department of Bone and Joint, Shenzhen People's Hospital, The First Affiliated Hospital of Nanfan University of Science and Technology, The Second Clinical Medical College of Jinan University Shenzhen 518020, Guangdong, P. R. China.""}, {'ForeName': 'Ronak Naveenchandra', 'Initials': 'RN', 'LastName': 'Kotian', 'Affiliation': 'Department of Orthopaedic Surgery, Victoria Hospital, Bangalore Medical College and Research Institute Bangalore, India.'}, {'ForeName': 'Wen-Qing', 'Initials': 'WQ', 'LastName': 'Xie', 'Affiliation': 'Department of Orthopaedics, Xiangya Hospital of Central South University Xiangya Road 87, Changsha 410008, Hunan, P. R. China.'}, {'ForeName': 'Yu-Sheng', 'Initials': 'YS', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedics, Xiangya Hospital of Central South University Xiangya Road 87, Changsha 410008, Hunan, P. R. China.'}, {'ForeName': 'Guang-Heng', 'Initials': 'GH', 'LastName': 'Li', 'Affiliation': ""Department of Bone and Joint, Shenzhen People's Hospital, The First Affiliated Hospital of Nanfan University of Science and Technology, The Second Clinical Medical College of Jinan University Shenzhen 518020, Guangdong, P. R. China.""}, {'ForeName': 'Xin-Jia', 'Initials': 'XJ', 'LastName': 'Hu', 'Affiliation': ""Department of Bone and Joint, Shenzhen People's Hospital, The First Affiliated Hospital of Nanfan University of Science and Technology, The Second Clinical Medical College of Jinan University Shenzhen 518020, Guangdong, P. R. China.""}, {'ForeName': 'Jin-Hu', 'Initials': 'JH', 'LastName': 'Xie', 'Affiliation': ""Department of Bone and Joint, Shenzhen People's Hospital, The First Affiliated Hospital of Nanfan University of Science and Technology, The Second Clinical Medical College of Jinan University Shenzhen 518020, Guangdong, P. R. China.""}, {'ForeName': 'Wen-Tao', 'Initials': 'WT', 'LastName': 'Liu', 'Affiliation': ""Department of Bone and Joint, Shenzhen People's Hospital, The First Affiliated Hospital of Nanfan University of Science and Technology, The Second Clinical Medical College of Jinan University Shenzhen 518020, Guangdong, P. R. China.""}, {'ForeName': 'Xiao-Ming', 'Initials': 'XM', 'LastName': 'Zhang', 'Affiliation': ""Department of Bone and Joint, Shenzhen People's Hospital, The First Affiliated Hospital of Nanfan University of Science and Technology, The Second Clinical Medical College of Jinan University Shenzhen 518020, Guangdong, P. R. China.""}]",American journal of translational research,[]
2062,32774759,The effect of intermittent hypoxia training on migraine: a randomized controlled trial.,"OBJECTIVE


To study the effect of intermittent hypoxia training (IHT) for migraine.
DESIGN


A single-blind, randomized controlled trial. All participants were recruited from a rehabilitation department in an acute university-affiliated hospital.
METHODS


Participants with migraines were randomly assigned to two groups (IHT group and control group). The Migraine Disability Assessment (MIDAS), Visual Analog Scale (VAS), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Vascular endothelial growth factor (VEGF), calcitonin gene related peptide (CGRP) and cerebrovascular hemodynamic parameters were collected at baseline and end of the 8 th  week. The attack frequencies of migraines were evaluated at 3 months.
RESULTS


Among the 48 subjects, five males and forty-three females, the ages ranged from 19 to 53 years old (mean ± SD = 31.3±7.78). MIDAS, SF-36, VAS, BAI, BDI, VEGF, CGRP and cerebrovascular hemodynamic parameters were improved after IHT intervention. There were significant differences between IHT group and the control group in MIDAS, SF-36, VAS, BAI, BDI, VEGF, CGRP and cerebrovascular hemodynamic parameters at the end of the 8 th  weeks (P<0.05). Attack frequencies were improved within 3 months after IH training intervention (P<0.01), but not in the control group (P>0.05). No adverse events occurred during the study.
CONCLUSION


IHT could improve migraines after intervention up to three months. IHT could be an effective method for relieving a migraine.",2020,"There were significant differences between IHT group and the control group in MIDAS, SF-36, VAS, BAI, BDI, VEGF, CGRP and cerebrovascular hemodynamic parameters at the end of the 8 th  weeks (P<0.05).","['All participants were recruited from a rehabilitation department in an acute university-affiliated hospital', '48 subjects, five males and forty-three females, the ages ranged from 19 to 53 years old (mean ± SD = 31.3±7.78', 'Participants with migraines', 'migraine']","['IHT', 'intermittent hypoxia training', 'intermittent hypoxia training (IHT']","['Attack frequencies', 'adverse events', 'attack frequencies of migraines', 'MIDAS, SF-36, VAS, BAI, BDI, VEGF, CGRP and cerebrovascular hemodynamic parameters', 'Migraine Disability Assessment (MIDAS), Visual Analog Scale (VAS), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Vascular endothelial growth factor (VEGF), calcitonin gene related peptide (CGRP) and cerebrovascular hemodynamic parameters']","[{'cui': 'C0587478', 'cui_str': 'Rehabilitation department'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",5.0,0.0636866,"There were significant differences between IHT group and the control group in MIDAS, SF-36, VAS, BAI, BDI, VEGF, CGRP and cerebrovascular hemodynamic parameters at the end of the 8 th  weeks (P<0.05).","[{'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Bao', 'Affiliation': ""Department of Rehabilitation Medicine, Yue Bei People's Hospital Shaoguan, China.""}, {'ForeName': 'Howe', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Physical Therapy, University of North Texas Health Science Center Fort Worth, USA.'}, {'ForeName': 'Hui-Yu', 'Initials': 'HY', 'LastName': 'Liu', 'Affiliation': ""Department of Rehabilitation Medicine, Yue Bei People's Hospital Shaoguan, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Long', 'Affiliation': ""Department of Hyperbaric Oxygen Medicine, Shenzhen People's Hospital Shenzhen, China.""}, {'ForeName': 'Jie-Wen', 'Initials': 'JW', 'LastName': 'Tan', 'Affiliation': 'Department of Rehabilitation Medicine, Xinhua College of Sun Yat-sen University Guangzhou, China.'}, {'ForeName': 'Zhi-Min', 'Initials': 'ZM', 'LastName': 'Zhu', 'Affiliation': ""Department of Rehabilitation Medicine, Lianjiang People's Hospital Lianjiang, China.""}]",American journal of translational research,[]
2063,32774771,"Biomarker analysis to predict the pathological response to neoadjuvant chemotherapy in locally advanced gastric cancer: An exploratory biomarker study of COMPASS, a randomized phase II trial.","BACKGROUND


The findings of COMPASS, a randomized phase II study, suggested that the regimens and courses of neoadjuvant chemotherapy (NAC) for locally advanced gastric cancer (GC) did not affect the pathological response. However, pathological complete response was achieved in 10% patients who received four courses of either S-1/cisplatin or paclitaxel/cisplatin. We hypothesized that if relevant biomarkers could be used to predict the suitable NAC regimen before treatment initiation, further improvements could be ensured in the outcomes of locally advanced GC.
MATERIALS AND METHODS


mRNA extraction, real-time polymerase chain reaction, and immunohistochemical analyses were performed using endoscopic biopsy specimens of primary tumors, collected prior to NAC, to determine the clinically relevant biomarkers.
RESULTS


TIMP1 ,  DSG2 ,  RRM1 ,  MUC2 ,  EGFR ,  ZDHHC14 , and  CLDN18.2  were identified as biomarker candidates, since their expression was significantly associated with the pathological responses to each NAC regimen. Furthermore,  TIMP1  and  DSG2  were identified as predictive biomarkers of the pathological response to each NAC regimen.
CONCLUSIONS


The effective prediction of the pathological response to NAC regimens in locally advanced GC using biomarkers identified from endoscopic biopsy specimens indicates the possibility of personalizing NAC based on biomarker analysis.",2020,"TIMP1 ,  DSG2 ,  RRM1 ,  MUC2 ,  EGFR ,  ZDHHC14 , and  CLDN18.2  were identified as biomarker candidates, since their expression was significantly associated with the pathological responses to each NAC regimen.","['locally advanced gastric cancer (GC', 'locally advanced gastric cancer']","['neoadjuvant chemotherapy (NAC', 'neoadjuvant chemotherapy', 'S-1/cisplatin or paclitaxel/cisplatin']","['TIMP1 ,  DSG2 ,  RRM1 ,  MUC2 ,  EGFR ,  ZDHHC14 , and  CLDN18.2', 'pathological complete response']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C1259395', 'cui_str': 'RRM1 protein, human'}, {'cui': 'C1528289', 'cui_str': 'MUC2 protein, human'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",,0.0347279,"TIMP1 ,  DSG2 ,  RRM1 ,  MUC2 ,  EGFR ,  ZDHHC14 , and  CLDN18.2  were identified as biomarker candidates, since their expression was significantly associated with the pathological responses to each NAC regimen.","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Oshima', 'Affiliation': 'Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Asahi-ku, Yokohama, Kanagawa 241-8515, Japan.'}, {'ForeName': 'Takaki', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Gastric Surgery, National Cancer Hospital, Chuo-ku, Tokyo 104-0045, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Miyagi', 'Affiliation': 'Kanagawa Cancer Center Research Institute, Asahi-ku, Yokohama, Kanagawa 241-8515, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Sakyo-ku, Kyoto, Kyoto 606-8507, Japan.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Graduate School of Environmental and Life Science, Okayama University, Kita-ku, Okayama, Okayama 700-8530, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Tanabe', 'Affiliation': 'Department of Gastroenterological and Transplant Surgery, Hiroshima University, Minami-ku, Hiroshima, Hiroshima 734-8551, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Surgery, National Hospital Organization Osaka National Hospital, Chuo-ku, Osaka, Osaka, 540-0006, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Chikusa-ku, Nagoya, Aichi 464-8681, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Matsui', 'Affiliation': 'Department of Surgery, Aichi Cancer Center, Aichi Hospital, Kakemachi, Okazaki, Aichi 444-0011, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Kimura', 'Affiliation': 'Department of Surgery, NTT West Japan Osaka Hospital, Tennouji-ku, Osaka, Osaka 543-0042, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Yokose', 'Affiliation': 'Department of Pathology, Kanagawa Cancer Center, Asahi-ku, Yokohama, Kanagawa 241-8515, Japan.'}, {'ForeName': 'Yukihiko', 'Initials': 'Y', 'LastName': 'Hiroshima', 'Affiliation': 'Kanagawa Cancer Center Research Institute, Asahi-ku, Yokohama, Kanagawa 241-8515, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Aoyama', 'Affiliation': 'Department of Surgery, Yokohama City University, Kanazawa-ku, Yokohama, Kanagawa 236-0004, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': 'Department of Gastric Surgery, National Cancer Hospital, Chuo-ku, Tokyo 104-0045, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ogata', 'Affiliation': 'Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Asahi-ku, Yokohama, Kanagawa 241-8515, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Cho', 'Affiliation': 'Department of Gastric Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Bunkyo-ku, Tokyo 113-8677, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Rino', 'Affiliation': 'Department of Surgery, Yokohama City University, Kanazawa-ku, Yokohama, Kanagawa 236-0004, Japan.'}, {'ForeName': 'Munetaka', 'Initials': 'M', 'LastName': 'Masuda', 'Affiliation': 'Department of Surgery, Yokohama City University, Kanazawa-ku, Yokohama, Kanagawa 236-0004, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Tsuburaya', 'Affiliation': 'Department of Surgery, Ozawa Hospital, Odawara, Kanagawa 250-0012, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Sakamoto', 'Affiliation': 'Tokai Central Hospital, Kakamigahara, Gifu 504-8601, Japan.'}]",Oncotarget,['10.18632/oncotarget.27658']
2064,32774912,"Efficacy of Diltiazem for the Control of Blood Pressure in Puerperal Patients with Severe Preeclampsia: A Randomized, Single-Blind, Controlled Trial.","Background


Postpartum preeclampsia is a serious disease related to high blood pressure that occurs commonly within the first six days after delivery.
Objective


To evaluate if diltiazem improves blood pressure parameters in early puerperium patients with severe preeclampsia.  Methodology . A randomized, single-blind longitudinal clinical trial of 42 puerperal patients with severe preeclampsia was carried out. Patients were randomized into two groups: the experimental group ( n  = 21) received diltiazem (60 mg) and the control group ( n  = 21) received nifedipine (10 mg). Both drugs were orally administered every 8 hours. Systolic, diastolic, and mean blood pressures as well as the heart rate were recorded and analyzed (two-way repeated measures ANOVA) at baseline and after 6, 12, 18, 24, 30, 36, 42, and 48 hours. Primary outcome measures were all the aforementioned blood pressure parameters. Secondary outcome measures included the number of hypertension and hypotension episodes along with the length of stay in the intensive care unit.
Results


No statistical differences were found between groups (diltiazem vs. nifedipine) regarding basal blood pressure parameters. Interarm differences in blood pressure (systolic, diastolic, and mean) and heart rate were statistically significant between treatment groups from 6 to 48 hours. Patients in the diltiazem group had lower blood pressure levels than patients in the nifedipine group. Significantly, patients who received diltiazem had fewer hypertension and hypotension episodes and stayed fewer days in the intensive care unit than those treated with nifedipine.
Conclusions


Diltiazem controlled arterial hypertension in a more effective and uniform manner in patients under study than nifedipine. Patients treated with diltiazem had fewer collateral effects and spent less time in the hospital. This trial is registered with NCT04222855.",2020,"Interarm differences in blood pressure (systolic, diastolic, and mean) and heart rate were statistically significant between treatment groups from 6 to 48 hours.","['early puerperium patients with severe preeclampsia', '42 puerperal patients with severe preeclampsia', 'Puerperal Patients with Severe Preeclampsia']","['diltiazem', 'Diltiazem', 'nifedipine', 'diltiazem vs. nifedipine']","['blood pressure parameters', 'blood pressure (systolic, diastolic, and mean) and heart rate', 'collateral effects and spent less time', 'hypertension and hypotension episodes', 'basal blood pressure parameters', 'number of hypertension and hypotension episodes along with the length of stay in the intensive care unit', 'aforementioned blood pressure parameters', 'Systolic, diastolic, and mean blood pressures as well as the heart rate', 'Blood Pressure', 'blood pressure levels']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0034042', 'cui_str': 'Puerperium'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0341950', 'cui_str': 'Severe pre-eclampsia'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]","[{'cui': 'C0012373', 'cui_str': 'Diltiazem'}, {'cui': 'C0028066', 'cui_str': 'Nifedipine'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1275670', 'cui_str': 'Collateral branch of vessel'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",42.0,0.10968,"Interarm differences in blood pressure (systolic, diastolic, and mean) and heart rate were statistically significant between treatment groups from 6 to 48 hours.","[{'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Arias-Hernández', 'Affiliation': 'Hospital De La Mujer, Prolongación Salvador Díaz Mirón 374, Colonia Santo Tomas, Delegación Miguel Hidalgo, C. P. 11340, México D. F., Mexico.'}, {'ForeName': 'Cruz', 'Initials': 'C', 'LastName': 'Vargas-De-León', 'Affiliation': 'Facultad De Matemáticas, Universidad Autónoma De Guerrero, Chilpancingo, Av. Lázaro Cárdenas S/N, Cd. Universitaria, 39087 Chilpancingo, Guerrero, Mexico.'}, {'ForeName': 'Claudia C', 'Initials': 'CC', 'LastName': 'Calzada-Mendoza', 'Affiliation': 'Instituto Politécnico Nacional Escuela Superior De Medicina, Plan De San Luis Y Díaz Mirón SN, Col. Casco De Santo Tomás, Delegación Miguel Hidalgo, C. P. 11340, México D. F, Mexico.'}, {'ForeName': 'María Esther', 'Initials': 'ME', 'LastName': 'Ocharan-Hernández', 'Affiliation': 'Instituto Politécnico Nacional Escuela Superior De Medicina, Plan De San Luis Y Díaz Mirón SN, Col. Casco De Santo Tomás, Delegación Miguel Hidalgo, C. P. 11340, México D. F, Mexico.'}]",International journal of hypertension,['10.1155/2020/5347918']
2065,32774924,Balanced Suspension versus Pillow on Preoperative Pain for Proximal Femur Fractures: A Randomized Controlled Trial.,"Introduction


To evaluate the efficacy of a balanced suspension system, using the Thomas splint, with Pearson attachment, compared with a pillow for preoperative pain in patients with proximal femoral fractures.
Materials and Methods


Sixty patients with proximal femur fractures were randomized into two groups: a balanced suspension group and a pillow group. In the first group, a balanced suspension was applied after length adjustment, to match the patient's leg and thigh. In the pillow group, a pillow was placed below the patient's leg, to position the patient's hip in a semiflexion and external rotation position. Preoperative pain severity, by using a verbal numerical rating scale (VNRS), the amount of morphine consumed, and complication were recorded.
Results


There were no differences in patient characteristics between the groups. The mean VNRS for pain was not statistically different between the groups, from the start of the study up to 48 hours. The mean of morphine consumption was not different between the groups at the start of the study, on day 1, and on day 2 ( p =0.25, 0.89, and 0.053, respectively).
Conclusions


A balanced suspension did not improve patient outcome to the same level as other tractions in previous studies. Hence, other methods for reducing pain, while waiting for definite operations, should be focused on. The clinical trial is registered with TCTR20150514002.",2020,"The mean VNRS for pain was not statistically different between the groups, from the start of the study up to 48 hours.","['Sixty patients with proximal femur fractures', 'patients with proximal femoral fractures', 'Proximal Femur Fractures']","['balanced suspension group and a pillow group', 'Balanced Suspension versus Pillow']","['mean of morphine consumption', 'Preoperative pain severity', 'mean VNRS for pain', 'verbal numerical rating scale (VNRS), the amount of morphine consumed, and complication']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015802', 'cui_str': 'Fracture of femur'}]","[{'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0182291', 'cui_str': 'Pillow'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",60.0,0.0249062,"The mean VNRS for pain was not statistically different between the groups, from the start of the study up to 48 hours.","[{'ForeName': 'Varah', 'Initials': 'V', 'LastName': 'Yuenyongviwat', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine, Prince of Songkla University, Songkhla 90110, Thailand.'}, {'ForeName': 'Chonthawat', 'Initials': 'C', 'LastName': 'Jiarasrisatien', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine, Prince of Songkla University, Songkhla 90110, Thailand.'}, {'ForeName': 'Khanin', 'Initials': 'K', 'LastName': 'Iamthanaporn', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine, Prince of Songkla University, Songkhla 90110, Thailand.'}, {'ForeName': 'Theerawit', 'Initials': 'T', 'LastName': 'Hongnaparak', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine, Prince of Songkla University, Songkhla 90110, Thailand.'}, {'ForeName': 'Boonsin', 'Initials': 'B', 'LastName': 'Tangtrakulwanich', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine, Prince of Songkla University, Songkhla 90110, Thailand.'}]",Advances in orthopedics,['10.1155/2020/3073892']
2066,32775064,What Is the Effect on Kinesio Taping on Pain and Gait in Patients With Patellofemoral Pain Syndrome?,"Introduction Patellofemoral pain syndrome (PFPS) is one of the leading causes of anterior knee pain treated by orthopedists and physical therapists. This syndrome predominantly affects young, active individuals, and remains a challenging syndrome to manage due to the lack of quantitative diagnostic criteria to monitor during treatment. The etiology of this syndrome is believed to be multifactorial, with the gait and movement patterns of a patient potentially contributing to pain due to increased stress on the knee. In this study, we investigated the gait of participants with PFPS using the GaitRite system (CIR Systems Inc., Clifton, NJ) before and after the application of Kinesio Tape in order to assess the impact of Kinesio Tape on cadence, stance time, and pain. Methods A convenience sample of 10 participants were recruited for this study, with five participants without PFPS serving as controls, and five with PFPS in the Kinesio Tape group. Participants in the Kinesio Tape groups served as their own internal control, ambulating both before and after taping. All participants ambulated across the GaitRite carpet three times and completed a visual analogue scale pain score for each trip. Results The results of our study found there to be no significant difference in the cadence for gait between the participants without PFPS and participants with PFPS (105.2 seconds vs. 105.1 seconds, p = 0.272), or in the stance time between the control and PFPS group (1.43 seconds vs. 1.44, p = 0.907). Similarly, no significant difference was found in participants with PFPS before and after Kinesio Taping in the cadence and stance times (105.1 seconds vs. 107.4 seconds, p =0.288, and 1.44 vs. 1.40, p = 0.272). There was a significant difference in pain in PFPS participants before and after taping, with a 112.5% reduction in pain reported after taping (3.4 vs. 1.6, p < 0.05). Discussion and conclusion This study is one of the first studies to utilize the GaitRite system in order to analyze the impact of Kinesio Tape on gait in participants with PFPS. While our study failed to demonstrate a significant difference in the gait of participants with PFPS in comparison to those without PFPS, we did demonstrate a significant reduction in pain after the application of Kinesio Tape. These results suggest other variables addressed by the Kinesio Tape may be causing the pain associated with PFPS.",2020,"Similarly, no significant difference was found in participants with PFPS before and after Kinesio Taping in the cadence and stance times (105.1 seconds vs. 107.4 seconds, p =0.288, and 1.44 vs. 1.40, p = 0.272).","['Patients With Patellofemoral Pain Syndrome', 'participants with PFPS using the GaitRite system (CIR Systems Inc., Clifton, NJ', 'Introduction Patellofemoral pain syndrome (PFPS', 'participants with PFPS', 'convenience sample of 10 participants were recruited for this study, with five participants without PFPS serving as controls, and five with PFPS in the Kinesio Tape group']","['Kinesio Tape', 'Kinesio Taping']","['Pain and Gait', 'cadence and stance times', 'pain', 'stance time', 'visual analogue scale pain score', 'cadence for gait', 'cadence, stance time, and pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877149', 'cui_str': 'Patellofemoral pain syndrome'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C4505491', 'cui_str': 'Kinesiotape'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}]",10.0,0.0397124,"Similarly, no significant difference was found in participants with PFPS before and after Kinesio Taping in the cadence and stance times (105.1 seconds vs. 107.4 seconds, p =0.288, and 1.44 vs. 1.40, p = 0.272).","[{'ForeName': 'Alec S', 'Initials': 'AS', 'LastName': 'Kellish', 'Affiliation': 'Orthopaedics, Cooper Medical School of Rowan University, Camden, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Kellish', 'Affiliation': 'Physical Therapy, Professional Physical Therapy, Westfield, USA.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Hakim', 'Affiliation': 'Internal Medicine, Cooper Medical School of Rowan University, Camden, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Miskiel', 'Affiliation': 'Orthopaedics, Cooper University Hospital, Camden, USA.'}, {'ForeName': 'Alisina', 'Initials': 'A', 'LastName': 'Shahi', 'Affiliation': 'Orthopaedics, Cooper University Hospital, Camden, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Kellish', 'Affiliation': 'Orthopaedics, School of Physical Therapy, Kean University, Elizabeth, USA.'}]",Cureus,['10.7759/cureus.8982']
2067,32775132,Effects of citrus juice fermented with  Lactobacillus plantarum  YIT 0132 on Japanese cedar pollinosis during probiotic consumption: an open study.,"Certain strains of lactic acid bacteria (LAB) have beneficial effects on Japanese cedar pollinosis (JCPsis), which is a major concern in Japan. Heat-killed  Lactobacillus plantarum  YIT 0132 (LP0132), selected for its ability to induce interleukin (IL)-10, has been shown to suppress JCPsis symptoms.  Lactobacillus casei  Shirota (LcS), a popular probiotic, potentially induces a high level of IL-12 and is reported to delay the onset of JCPsis symptoms. However, it is unclear whether a combination of different types of LAB exerts additional effects without interfering with the benefits of each individual LAB. Thus, we conducted a pilot study to investigate the effects of LP0132-fermented citrus juice on JCPsis during simultaneous consumption of LcS-fermented milk. Fifty-nine subjects with JCPsis were allocated to two groups after a 2-week preconsumption period: one group consumed LP0132-fermented citrus juice and LcS-fermented milk (LcS+LP0132 group) for 12 weeks, while the other consumed LcS-fermented milk alone (LcS group). JCPsis symptoms, JCPsis-associated quality of life (QOL) impairment, and bowel movements were assessed by questionnaires. Compared with the LcS group, the LcS+LP0132 group showed significant alleviation of total symptoms and total ocular symptoms during the consumption period, as well as relief of impaired QOL. Bowel movements were significantly improved during the consumption period compared with the baseline in a combined analysis of all subjects in the two groups. In conclusion, LP0132-fermented citrus juice appears to have positive effects on some JCPsis symptoms and QOL in a population consuming immunomodulating probiotics such as LcS-fermented milk.",2020,Bowel movements were significantly improved during the consumption period compared with the baseline in a combined analysis of all subjects in the two groups.,"['Japanese cedar pollinosis (JCPsis', 'Japanese cedar pollinosis during probiotic consumption', 'Fifty-nine subjects with JCPsis']","['citrus juice fermented with  Lactobacillus plantarum  YIT 0132', 'lactic acid bacteria (LAB', 'LcS+LP0132', 'LP0132-fermented citrus juice and LcS-fermented milk (LcS+LP0132 group) for 12 weeks, while the other consumed LcS-fermented milk alone (LcS group', 'LcS', 'LP0132-fermented citrus juice', 'Lactobacillus casei  Shirota (LcS', 'Heat-killed  Lactobacillus plantarum']","['total symptoms and total ocular symptoms', 'Bowel movements', 'JCPsis symptoms, JCPsis-associated quality of life (QOL) impairment, and bowel movements', 'relief of impaired QOL']","[{'cui': 'C0996622', 'cui_str': 'Cedar, Japanese'}, {'cui': 'C0018621', 'cui_str': 'Seasonal allergic rhinitis'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3830128', 'cui_str': '59'}]","[{'cui': 'C2347777', 'cui_str': 'Citrus juice'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C1210581', 'cui_str': 'Lactobacillales'}, {'cui': 'C0268314', 'cui_str': 'Cholestasis-edema syndrome, Norwegian type'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0162388', 'cui_str': 'Killing'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0996622', 'cui_str': 'Cedar, Japanese'}, {'cui': 'C0018621', 'cui_str': 'Seasonal allergic rhinitis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}]",59.0,0.0265,Bowel movements were significantly improved during the consumption period compared with the baseline in a combined analysis of all subjects in the two groups.,"[{'ForeName': 'Sayaka', 'Initials': 'S', 'LastName': 'Kakiyama', 'Affiliation': 'Yakult Central Institute, 5-11 Izumi, Kunitachi-shi, Tokyo 186-8650, Japan.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kubota', 'Affiliation': 'Yakult Central Institute, 5-11 Izumi, Kunitachi-shi, Tokyo 186-8650, Japan.'}, {'ForeName': 'Kan', 'Initials': 'K', 'LastName': 'Shida', 'Affiliation': 'Yakult Central Institute, 5-11 Izumi, Kunitachi-shi, Tokyo 186-8650, Japan.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Harima-Mizusawa', 'Affiliation': 'Yakult Central Institute, 5-11 Izumi, Kunitachi-shi, Tokyo 186-8650, Japan.'}]","Bioscience of microbiota, food and health",['10.12938/bmfh.2019-017']
2068,32775408,Prognostic Nomograms for Primary High-Grade Glioma Patients in Adult: A Retrospective Study Based on the SEER Database.,"Purpose


In our study, we aimed to screen the risk factors that affect overall survival (OS) and cancer-specific survival (CSS) in adult glioma patients and to develop and evaluate nomograms.
Methods


Primary high-grade gliomas patients being retrieved from the surveillance, epidemiology and end results (SEER) database, between 2004 and 2015, then they randomly assigned to a training group and a validation group. Univariate and multivariate Cox analysis models were used to choose the variables significantly correlated with the prognosis of high-grade glioma patients. And these variables were used to construct the nomograms. Next, concordance index (C-index), calibration plot and receiver operating characteristics (ROCs) curve were used to evaluate the accuracy of the nomogram model. In addition, the decision curve analysis (DCA) was used to analyze the benefit of nomogram and prognostic indicators commonly used in clinical practice.
Results


A total of 6395 confirmed glioma patients were selected from the SEER database, divided into training set (n =3166) and validation set (n =3229). Age at diagnosis, tumor grade, tumor size, histological type, surgical type, radiotherapy and chemotherapy were screened out by Cox analysis model. For OS nomogram, the C-index of the training set was 0.741 (95% CI: 0.751-0.731), and the validation set was 0.738 (95% CI: 0.748-0.728). For CSS nomogram, the C-index of the training set was 0.739 (95% CI: 0.749-0.729), and the validation set was 0.738 (95% CI: 0.748-0.728). The net benefit and net reduction in inverventions of nomograms in the decision curve analysis (DCA) was higher than histological type.
Conclusions


We developed nomograms to predict 3- and 5-year OS rates and 3- and 5-year CSS rates in adult high-grade glioma patients. Both the training set and the validation set showed good calibration and validation, indicating the clinical applicability of the nomogram and good predictive results.",2020,Univariate and multivariate Cox analysis models were used to choose the variables significantly correlated with the prognosis of high-grade glioma patients.,"['adult high-grade glioma patients', '6395 confirmed glioma patients were selected from the SEER database, divided into training set (n\u2009=3166) and validation set (n\u2009=3229', 'Primary High-Grade Glioma Patients in Adult', 'adult glioma patients', 'Methods\n\n\nPrimary high-grade gliomas patients being retrieved from the surveillance, epidemiology and end results (SEER) database, between 2004 and 2015']",[],"['overall survival (OS) and cancer-specific survival (CSS', '5-year OS rates and 3- and 5-year CSS rates', 'concordance index (C-index), calibration plot and receiver operating characteristics (ROCs) curve']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0555198', 'cui_str': 'Glioma, malignant, no ICD-O subtype'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",6395.0,0.0471218,Univariate and multivariate Cox analysis models were used to choose the variables significantly correlated with the prognosis of high-grade glioma patients.,"[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Neurosurgery, First Affiliated Hospital of China Medical University, Shenyang 110001, China.'}, {'ForeName': 'Mingze', 'Initials': 'M', 'LastName': 'Yao', 'Affiliation': 'Department of Neurosurgery, First Affiliated Hospital of China Medical University, Shenyang 110001, China.'}, {'ForeName': 'Shengrong', 'Initials': 'S', 'LastName': 'Long', 'Affiliation': 'Department of Neurosurgery, First Affiliated Hospital of China Medical University, Shenyang 110001, China.'}, {'ForeName': 'Chengran', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Neurosurgery, First Affiliated Hospital of China Medical University, Shenyang 110001, China.'}, {'ForeName': 'Lun', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Neurosurgery, Anshan Hospital of the First Hospital of China Medical University, Anshan 114000, China.'}, {'ForeName': 'Yinghui', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Medical Genetics, School of Life Science, China Medical University, Shenyang 110122, China.'}, {'ForeName': 'Guangyu', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of Neurosurgery, First Affiliated Hospital of China Medical University, Shenyang 110001, China.'}]",BioMed research international,['10.1155/2020/1346340']
2069,32775414,Effect of Contextual Interference in the Practicing of a Computer Task in Individuals Poststroke.,"Objectives


Sensory and motor alterations resulting from stroke often impair the performance and learning of motor skills. The present study is aimed at investigating whether and how poststroke individuals and age- and sex-matched healthy controls benefit from a contextual interference effect on the practice of a maze task (i.e., constant  vs.  random practice) performed on the computer.
Methods


Participants included 21 poststroke individuals and 21 healthy controls, matched by sex and age (30 to 80 years). Both groups were divided according to the type of the practice (constant or random) presented in the acquisition phase of the learning protocol. For comparison between the groups, types of practice, and blocks of attempts, the analysis of variance with Tukey's post hoc test ( p  < 0.05) was used.
Results


Poststroke individuals presented longer movement times as compared with the control group. In addition, only poststroke individuals who performed the task with random practice showed improved performance at the transfer phase. Moreover, randomized practice enabled poststroke individuals to perform the transfer task similarly to individuals without any neurological impairment.
Conclusion


The present findings indicated a significant effect of contextual interference of practice in poststroke individuals, suggesting that applying randomized training must be considered when designing rehabilitation protocols for this population.",2020,"Results


Poststroke individuals presented longer movement times as compared with the control group.","['Individuals Poststroke', 'poststroke individuals', 'Methods\n\n\nParticipants included 21 poststroke individuals and 21 healthy controls, matched by sex and age (30 to 80 years', 'poststroke individuals and age- and sex-matched healthy controls']",['Contextual Interference'],['longer movement times'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0521102', 'cui_str': 'Interferes with'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0259029,"Results


Poststroke individuals presented longer movement times as compared with the control group.","[{'ForeName': 'Alice Haniuda', 'Initials': 'AH', 'LastName': 'Moliterno', 'Affiliation': 'University of West Paulista-UNOESTE-Presidente Prudente, SP, Brazil.'}, {'ForeName': 'Fernanda Vieira', 'Initials': 'FV', 'LastName': 'Bezerra', 'Affiliation': 'University of West Paulista-UNOESTE-Presidente Prudente, SP, Brazil.'}, {'ForeName': 'Louanne Angélica', 'Initials': 'LA', 'LastName': 'Pires', 'Affiliation': 'University of West Paulista-UNOESTE-Presidente Prudente, SP, Brazil.'}, {'ForeName': 'Sarah Santos', 'Initials': 'SS', 'LastName': 'Roncolato', 'Affiliation': 'University of West Paulista-UNOESTE-Presidente Prudente, SP, Brazil.'}, {'ForeName': 'Talita Dias', 'Initials': 'TD', 'LastName': 'da Silva', 'Affiliation': 'Grupo de Pesquisa em Aplicações Tecnológicas em Reabilitação School of Arts, Sciences and Humanities-EACH-University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Thais', 'Initials': 'T', 'LastName': 'Massetti', 'Affiliation': 'Grupo de Pesquisa em Aplicações Tecnológicas em Reabilitação School of Arts, Sciences and Humanities-EACH-University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Deborah Cristina Gonçalves Luiz', 'Initials': 'DCGL', 'LastName': 'Fernani', 'Affiliation': 'University of West Paulista-UNOESTE-Presidente Prudente, SP, Brazil.'}, {'ForeName': 'Fernando Henrique', 'Initials': 'FH', 'LastName': 'Magalhães', 'Affiliation': 'Grupo de Pesquisa em Aplicações Tecnológicas em Reabilitação School of Arts, Sciences and Humanities-EACH-University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Carlos Bandeira', 'Initials': 'CB', 'LastName': 'de Mello Monteiro', 'Affiliation': 'Grupo de Pesquisa em Aplicações Tecnológicas em Reabilitação School of Arts, Sciences and Humanities-EACH-University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Maria Tereza Artero Prado', 'Initials': 'MTAP', 'LastName': 'Dantas', 'Affiliation': 'University of West Paulista-UNOESTE-Presidente Prudente, SP, Brazil.'}]",BioMed research international,['10.1155/2020/2937285']
2070,32775700,Intravenous acetaminophen vs intravenous ibuprofen to close a patent ductus arteriosus closure: A pilot randomized controlled trial.,,2020,,['patent ductus arteriosus closure'],"['ibuprofen', 'Intravenous acetaminophen']",[],"[{'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]",[],,0.105511,,"[{'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'Tauber', 'Affiliation': ""Department of Pediatrics, Bernard and Millie Duker Children's Hospital Albany Medical Center Albany New York.""}, {'ForeName': 'Ronnelle', 'Initials': 'R', 'LastName': 'King', 'Affiliation': ""Department of Pediatrics, Bernard and Millie Duker Children's Hospital Albany Medical Center Albany New York.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Colon', 'Affiliation': ""Department of Pediatrics, Bernard and Millie Duker Children's Hospital Albany Medical Center Albany New York.""}]",Health science reports,['10.1002/hsr2.183']
2071,32775734,Psychoeducational Group Therapy for sexual function and marital satisfaction in Iranian couples with sexual dysfunction disorder.,"Background


Having sexual relations plays a very important role in the success and scope of procreation. Understanding sexual function can lead to sexual satisfaction and ultimately to marital satisfaction and reconciliation of spouses.
Objective


The aim of this study was to evaluate the effectiveness of a psychoeducational programme on sexual function and marital satisfaction of Iranian couples.
Materials and methods


This is a semi-experimental pre-test and post-test study with control group. The statistical population included all couples diagnosed with sexual dysfunction referred to Bahar Consulting Center in Mashhad in 2019. A total of 40 individuals were randomly assigned to the two treatment conditions which were experimental (n = 20) and control (n = 20) forming two groups. The individuals assigned to experimental condition experienced a 10 session psychoeducational program and the control condition comprised of Treatment As Usual (TAU) which was based on medical and general counseling regime. The data collection tool was marital satisfaction and sexual function questionnaire. Data was analyzed using SPSS version 22 software.
Results


there is a significant difference between the amount of sexual function and marital satisfaction before and after the test in experimental group (p < 0.01). The results of this study showed that Psychoeducational Group Therapy improved the sexual performance and improved marital satisfaction.
Conclusion


Psychoeducational Group Therapy helps to increase marital satisfaction and sexual functioning of married couples. Therefore, this intervention is recommended as an effective program for improving marital satisfaction and sexual performance of couples. It can help to strengthen the foundation of the family.",2020,there is a significant difference between the amount of sexual function and marital satisfaction before and after the test in experimental group (p < 0.01).,"['couples diagnosed with sexual dysfunction referred to Bahar Consulting Center in Mashhad in 2019', 'A total of 40 individuals', 'married couples', 'Iranian couples with sexual dysfunction disorder']","['Psychoeducational Group Therapy', 'psychoeducational programme', '10 session psychoeducational program and the control condition comprised of Treatment']","['sexual function and marital satisfaction', 'sexual performance and improved marital satisfaction', 'marital satisfaction and sexual function questionnaire', 'marital satisfaction and sexual functioning']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",40.0,0.0179953,there is a significant difference between the amount of sexual function and marital satisfaction before and after the test in experimental group (p < 0.01).,"[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Tahan', 'Affiliation': 'Young Researchers and Elite Club, Birjand Branch, Islamic Azad University, Birjand, Iran.'}, {'ForeName': 'Tamkeen', 'Initials': 'T', 'LastName': 'Saleem', 'Affiliation': 'Department of Psychology, International Islamic University, Islamabad, Pakistan.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Moshtagh', 'Affiliation': 'Social Determinants of Health Research Center, Faculty of Health, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Fattahi', 'Affiliation': 'Department of Midwifery, Birjand Branch, Islamic Azad University, Birjand, Iran.'}, {'ForeName': 'Raziyeh', 'Initials': 'R', 'LastName': 'Rahimi', 'Affiliation': 'Department of Midwifery, Birjand Branch, Islamic Azad University, Birjand, Iran.'}]",Heliyon,['10.1016/j.heliyon.2020.e04586']
2072,32775761,trips4health : Protocol of a single-blinded randomised controlled trial incentivising adults to use public transport for physical activity gain.,"Background


Public transport (PT) users typically accumulate more physical activity (PA) than private motor vehicle users yet redressing physical inactivity through transport-related PA (TRPA) interventions has received limited attention. Further, incentive-based strategies can increase leisure-time PA but their impact on TRPA, is unclear. This study's objective is to determine the impact of an incentive-based strategy on TRPA in a regional Australian setting.
Methods


trips4health  is a single-blinded randomised controlled trial with a four-month intervention phase and subsequent six-month maintenance phase. Participants will be randomised to: an incentives-based intervention (bus trip credit for reaching bus trip targets, weekly text messages to support greater bus use, written PA guidelines); or an active control (written PA guidelines only). Three hundred and fifty adults (≥18 years) from southern Tasmania will be recruited through convenience methods, provide informed consent and baseline information, then be randomised. The primary outcome is change in accelerometer measured average daily step count at baseline and four- and ten-months later. Secondary outcomes are changes in: measured and self-reported travel behaviour (e.g. PT use), PA, sedentary behaviour; self-reported and measured (blood pressure, waist circumference, height, weight) health; travel behaviour perspectives (e.g. enablers/barriers); quality of life; and transport-related costs. Linear mixed model regression will determine group differences. Participant and PT provider level process evaluations will be conducted and intervention costs to the provider determined.
Discussion


trips4health  will determine the effectiveness of an incentive-based strategy to increase TRPA by targeting PT use. The findings will enable evidence-informed decisions about the worthwhileness of such strategies.
Trial registration


ACTRN12619001136190.
Universal trial number


U1111-1233-8050.",2020,"Secondary outcomes are changes in: measured and self-reported travel behaviour (e.g. PT use), PA, sedentary behaviour; self-reported and measured (blood pressure, waist circumference, height, weight) health; travel behaviour perspectives (e.g. enablers/barriers); quality of life; and transport-related costs.","['Three hundred and fifty adults (≥18 years) from southern Tasmania', 'trips4health ']","['\n\n\nPublic transport (PT', 'incentives-based intervention (bus trip credit for reaching bus trip targets, weekly text messages to support greater bus use, written PA guidelines); or an active control (written PA guidelines only', 'public transport for physical activity gain']","['change in accelerometer measured average daily step count', 'changes in: measured and self-reported travel behaviour (e.g. PT use), PA, sedentary behaviour; self-reported and measured (blood pressure, waist circumference, height, weight) health; travel behaviour perspectives (e.g. enablers/barriers); quality of life; and transport-related costs']","[{'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039335', 'cui_str': 'Tasmania'}]","[{'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0077275', 'cui_str': 'Triptorelin'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0040802', 'cui_str': 'Travel'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",350.0,0.208032,"Secondary outcomes are changes in: measured and self-reported travel behaviour (e.g. PT use), PA, sedentary behaviour; self-reported and measured (blood pressure, waist circumference, height, weight) health; travel behaviour perspectives (e.g. enablers/barriers); quality of life; and transport-related costs.","[{'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Sharman', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ball', 'Affiliation': 'Institute for Physical Activity and Nutrition, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Greaves', 'Affiliation': 'Institute of Transport and Logistic Studies, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Jose', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Morse', 'Affiliation': 'Metro Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Blizzard', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Wells', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Venn', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Palmer', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lester', 'Affiliation': 'Local Government Association of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': 'Department of Health, Tasmanian Government, Hobart, Tasmania, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Harpur', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'V J', 'Initials': 'VJ', 'LastName': 'Cleland', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100619']
2073,32773601,A combination of pain indices based on momentary assessments can predict placebo response in patients with fibromyalgia syndrome.,"Many factors are known to affect assay sensitivity; however, limited attention has been devoted to understanding whether characteristics of patients' baseline pain impact assay sensitivity. In this study, we tested whether a combination of three baseline pain indices based on ecological momentary assessments (EMA) could detect patients with enhanced responses to placebo. The analysis was conducted with secondary data from two clinical trials in fibromyalgia patients (N=2084). For each patient, pain intensity, pain variability (individual standard deviation), and pain consistency (first-order autocorrelation) were computed from baseline EMA. A latent profile analysis (LPA) identified three subgroups of patients based on these indices. Group 1 (n=857, 41.3%) showed the lowest pain intensity levels, coupled with the highest consistency and greatest variability of pain. Group 3 (n=110, 5.3%) showed the opposite pattern, and group 2 (n=1109, 53.4%) showed intermediate levels on all pain indices. It was then tested whether the subgroups moderated treatment effects (changes in pain for active treatment versus placebo) using repeated-measures ANOVA. Treatment effects varied significantly between subgroups. Patients in group 3 demonstrated greater reduction in pain in response to placebo then those in groups 1 and 2. Further analysis showed that the removal of patients in class 3 would significantly enhance the observed treatment effect by 8-15%. In conclusion, profiles of pain characteristics derived from baseline EMA may be useful for detecting patient subgroups with enhanced placebo responses that can diminish assay sensitivity in pain clinical trials.",2020,"Group 1 (n=857, 41.3%) showed the lowest pain intensity levels, coupled with the highest consistency and greatest variability of pain.","['fibromyalgia patients (N=2084', 'patients with fibromyalgia syndrome']",['placebo'],"['variability of pain', 'pain intensity, pain variability (individual standard deviation), and pain consistency (first-order autocorrelation', 'lowest pain intensity levels', 'intermediate levels on all pain indices', 'pain']","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.232416,"Group 1 (n=857, 41.3%) showed the lowest pain intensity levels, coupled with the highest consistency and greatest variability of pain.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Obbarius', 'Affiliation': 'Dornsife Center for Self-Report Science, University of Southern California, Los Angeles, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schneider', 'Affiliation': 'Dornsife Center for Self-Report Science, University of Southern California, Los Angeles, USA.'}, {'ForeName': 'Arthur A', 'Initials': 'AA', 'LastName': 'Stone', 'Affiliation': 'Dornsife Center for Self-Report Science, University of Southern California, Los Angeles, USA.'}]",Pain,['10.1097/j.pain.0000000000002025']
2074,32773602,"Double-blind, randomized, placebo-controlled crossover trial of alpha-lipoic acid for the treatment of fibromyalgia pain: the IMPALA trial.","Fibromyalgia is a common and challenging chronic pain disorder with few, if any, highly effective and well tolerated treatments. Alpha-lipoic acid (ALA) is a non-sedating antioxidant with evidence of efficacy in the treatment of symptomatic diabetic neuropathy that has not been evaluated in the setting of fibromyalgia treatment. Thus, we conducted a single-centre, proof-of-concept, randomized, placebo-controlled, crossover trial of ALA for the treatment of fibromyalgia. Twenty-seven participants were recruited and 24 participants completed both treatment periods of the trial. The median maximal tolerated dose of ALA in this trial was 1,663 mg/day. Treatment-emergent adverse events with ALA were infrequent and not statistically different from placebo. For the primary outcome of pain intensity, and for several other validated secondary outcomes, there were no statistically significant differences between placebo and ALA. A post hoc exploratory subgroup analysis showed a significant interaction between gender and treatment with a significant favourable placebo-ALA difference in pain for males, but not for females. Overall, the results of this trial do not provide any evidence to suggest promise for ALA as an effective treatment for fibromyalgia, which is predominantly prevalent in females. This negative clinical trial represents an important step in a collective strategy to identify new, better tolerated and more effective treatments for fibromyalgia.",2020,"For the primary outcome of pain intensity, and for several other validated secondary outcomes, there were no statistically significant differences between placebo and ALA.","['fibromyalgia pain', 'Twenty-seven participants were recruited and 24 participants completed both treatment periods of the trial']","['Alpha-lipoic acid (ALA', 'ALA', 'alpha-lipoic acid', 'placebo']","['pain intensity', 'median maximal tolerated dose of ALA']","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}]",27.0,0.743478,"For the primary outcome of pain intensity, and for several other validated secondary outcomes, there were no statistically significant differences between placebo and ALA.","[{'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Gilron', 'Affiliation': ""Department of Anesthesiology & Perioperative Medicine, Kingston Health Sciences Centre and Queen's University, Kingston, Ontario Canada.""}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Robb', 'Affiliation': ""Department of Anesthesiology & Perioperative Medicine, Kingston Health Sciences Centre and Queen's University, Kingston, Ontario Canada.""}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Tu', 'Affiliation': ""Departments of Public Health Sciences and Mathematics and Statistics, and the Cancer Research Institute, Queen's University, Kingston, Ontario.""}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Holden', 'Affiliation': ""Department of Psychology, Queen's University, Kingston, Ontario.""}, {'ForeName': 'Tanveer', 'Initials': 'T', 'LastName': 'Towheed', 'Affiliation': ""Department of Medicine, Division of Rheumatology, Queen's University, Kingston, Ontario.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ziegler', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Lebiniz Center for Diabetes Research and Division of Endocrinology and Diabetology, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Louie', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology & Perioperative Medicine, Kingston Health Sciences Centre and Queen's University, Kingston, Ontario Canada.""}, {'ForeName': 'Roumen', 'Initials': 'R', 'LastName': 'Milev', 'Affiliation': ""Centre for Neuroscience Studies, Queen's University, Kingston, Ontario Canada.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gray', 'Affiliation': 'Gray Research Consulting, Pharmacy Research Services, EpiPharm Consultants, Joyceville, Ontario.'}]",Pain,['10.1097/j.pain.0000000000002028']
2075,32773608,"Femtosecond laser-assisted cataract surgery compared with phacoemulsification cataract surgery (FACT): a randomised non-inferiority trial, 1 year outcomes.","PURPOSE


To report the 1 year outcomes of a randomised trial comparing femtosecond laser assisted cataract surgery (FLACS) and phacoemulsification cataract surgery (PCS).
SETTING


Moorfields Eye Hospital, New Cross Hospital and Sussex Eye Hospital, UK DESIGN:: Multicentre, randomised controlled non inferiority trial.
METHODS


311 of 392 (79%) participants allocated to FLACS and 292 of 393 (74%) participants allocated to PCS attended follow-up at 1 year. Postoperative assessments were masked to the allocated intervention. Outcomes included UDVA, CDVA, complications, corneal endothelial cell count and patient reported outcomes measures. ISRCTN77602616.
RESULTS


Mean UDVA was 0.14 (SD 0.22) for FLACS and 0.17 (0.25) for PCS with difference between treatment arms of -0.03 logMAR (95% CI: -0.06 to 0.01, p=0.17). Mean CDVA was 0.003 (0.18) for FLACS and 0.03 (0.23) for PCS with difference of -0.03 logMAR (95% CI -0.06 to 0.01, p=0.11). 75% of both FLACS (230/307) and PCS (218/290) cases were within ±0.5D refractive target, and 95% FLACS (292/307) and 96% PCS (279/290) cases within ±1.0D. There were no significant differences between arms for all other outcomes with the exception of binocular CDVA mean difference -0.02 (-0.05 to 0.002) logMAR (p=0.036) favouring FLACS. The mean cost difference was £167.62 per patient greater for FLACS (95% of iterations between -£14.12 and £341.67).
CONCLUSIONS


PCS is not inferior to FLACS in terms of vision, patient reported health and safety outcomes after one year follow-up. A difference was found for binocular CDVA, which whilst statistically significant, was not clinically important. FLACS is not cost effective.",2020,There were no significant differences between arms for all other outcomes with the exception of binocular CDVA mean difference -0.02 (-0.05 to 0.002) logMAR,"['Moorfields Eye Hospital, New Cross Hospital and Sussex Eye Hospital, UK DESIGN', '311 of 392 (79']","['phacoemulsification cataract surgery (FACT', 'femtosecond laser assisted cataract surgery (FLACS) and phacoemulsification cataract surgery (PCS', 'logMAR', 'FLACS', 'Femtosecond laser-assisted cataract surgery']","['mean cost difference', 'UDVA, CDVA, complications, corneal endothelial cell count and patient reported outcomes measures', 'Mean CDVA', 'Mean UDVA', 'binocular CDVA']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}]",,0.253575,There were no significant differences between arms for all other outcomes with the exception of binocular CDVA mean difference -0.02 (-0.05 to 0.002) logMAR,"[{'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Day', 'Affiliation': ': The NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, London, UK. EC1V 2PD.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Burr', 'Affiliation': ': School of Medicine, University of St. Andrews, UK. KY16 9TF.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Bennett', 'Affiliation': ': UCL Comprehensive Clinical Trials Unit (CCTU), 90 High Holborn, 2nd Floor, London, UK.WCV6LJ.'}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Doré', 'Affiliation': ': UCL Comprehensive Clinical Trials Unit (CCTU), 90 High Holborn, 2nd Floor, London, UK.WCV6LJ.'}, {'ForeName': 'Catey', 'Initials': 'C', 'LastName': 'Bunce', 'Affiliation': "": Department of Primary Care & Public Health Sciences, King's College London, London, UK. WC2R 2LS.""}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Hunter', 'Affiliation': ': UCL Comprehensive Clinical Trials Unit (CCTU), 90 High Holborn, 2nd Floor, London, UK.WCV6LJ.'}, {'ForeName': 'Mayank A', 'Initials': 'MA', 'LastName': 'Nanavaty', 'Affiliation': ': Sussex Eye Hospital, Brighton & Sussex University Hospitals NHS Trust, Eastern Road, Brighton, UK. BN2 5BF.'}, {'ForeName': 'Kamaljit S', 'Initials': 'KS', 'LastName': 'Balaggan', 'Affiliation': ': Wolverhampton and Midlands Eye Infirmary, New Cross Hospital, Royal Wolverhampton NHS Trust, Wolverhampton, West Midlands. WV10 0QP.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Wilkins', 'Affiliation': ': The NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, London, UK. EC1V 2PD.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000257']
2076,32773628,"Influence of the Retrocolic Versus Antecolic Route for Alimentary Tract Reconstruction on Delayed Gastric Emptying After Pancreatoduodenectomy: A Multicenter, Noninferiority Randomized Controlled Trial.","OBJECTIVE


This study aimed to determine whether retrocolic alimentary tract reconstruction is noninferior to antecolic reconstruction in terms of DGE incidence after pancreatoduodenectomy (PD) and investigated patients' postoperative nutritional status.
SUMMARY OF BACKGROUND DATA


The influence of the route of alimentary tract reconstruction on DGE after PD is controversial.
METHODS


Patients from 9 participating institutions scheduled for PD were randomly allocated to the retrocolic or antecolic reconstruction groups. The primary outcome was incidence of DGE, defined according to the 2007 version of the International Study Group for Pancreatic Surgery definition. Noninferiority would be indicated if the incidence of DGE in the retrocolic group did not exceed that in the antecolic group by a margin of 10%. Patients' postoperative nutrition data were compared as secondary outcomes.
RESULTS


Total, 109 and 103 patients were allocated to the retrocolic and antecolic reconstruction group, respectively (n = 212). Baseline characteristics were similar between both groups. DGE occurred in 17 (15.6%) and 13 (12.6%) patients in the retrocolic and antecolic group, respectively (risk difference; 2.97%, 95% confidence interval; -6.3% to 12.6%, which exceeded the specified margin of 10%). There were no differences in the incidence of other postoperative complications and in the duration of hospitalization. Postoperative nutritional indices were similar between both groups.
CONCLUSIONS


This trial could not demonstrate the noninferiority of retrocolic to antecolic alimentary tract reconstruction in terms of DGE incidence. The alimentary tract should not be reconstructed via the retrocolic route after PD, to prevent DGE.",2020,"Postoperative nutritional indices were similar between both groups.
","['Patients from 9 participating institutions scheduled for PD', 'Total, 109 and 103 patients were allocated to the retrocolic and antecolic reconstruction group, respectively (n = 212']","['alimentary tract reconstruction', 'retrocolic alimentary tract reconstruction', 'Pancreatoduodenectomy', 'pancreatoduodenectomy (PD', 'Retrocolic Versus Antecolic Route for Alimentary Tract Reconstruction', 'retrocolic or antecolic reconstruction']","['postoperative nutrition data', 'Delayed Gastric Emptying', 'incidence of other postoperative complications', 'incidence of DGE', 'DGE', 'Postoperative nutritional indices', 'duration of hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0013153', 'cui_str': 'Route of administration'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0028710', 'cui_str': 'Nutrition Index'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.112568,"Postoperative nutritional indices were similar between both groups.
","[{'ForeName': 'Hirochika', 'Initials': 'H', 'LastName': 'Toyama', 'Affiliation': 'Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery, Kobe University Graduate School of Medicine, Hyogo, Japan.'}, {'ForeName': 'Ippei', 'Initials': 'I', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Surgery, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Mizumoto', 'Affiliation': 'Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery, Kobe University Graduate School of Medicine, Hyogo, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Fujita', 'Affiliation': 'Department of Surgery, Seirei Mikatahara General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Shinobu', 'Initials': 'S', 'LastName': 'Tsuchida', 'Affiliation': 'Department of Surgery, Yodogawa Christian Hospital, Osaka, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Kanbara', 'Affiliation': 'Department of Surgery, Saiseikai Suita Hospital, Osaka, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Kadowaki', 'Affiliation': 'Department of Surgery, Japan Red Cross Kobe Hospital, Hyogo, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Maeda', 'Affiliation': 'Department of Surgery, Kobe Rosai Hospital, Hyogo, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Okano', 'Affiliation': 'Department of Gastroenterological Surgery, Kagawa University, Kagawa, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Fukuoka', 'Affiliation': 'Department of Surgery, Steel Memorial Hirohata Hospital, Hyogo, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Takase', 'Affiliation': 'Department of Surgery, Hyogo Prefectural Kakogawa Medical Center, Hyogo, Japan.'}, {'ForeName': 'Sachiyo', 'Initials': 'S', 'LastName': 'Shirakawa', 'Affiliation': 'Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery, Kobe University Graduate School of Medicine, Hyogo, Japan.'}, {'ForeName': 'Sachio', 'Initials': 'S', 'LastName': 'Terai', 'Affiliation': 'Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery, Kobe University Graduate School of Medicine, Hyogo, Japan.'}, {'ForeName': 'Hideyo', 'Initials': 'H', 'LastName': 'Mukubo', 'Affiliation': 'Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery, Kobe University Graduate School of Medicine, Hyogo, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ishida', 'Affiliation': 'Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery, Kobe University Graduate School of Medicine, Hyogo, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Yamashita', 'Affiliation': 'Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery, Kobe University Graduate School of Medicine, Hyogo, Japan.'}, {'ForeName': 'Kimihiko', 'Initials': 'K', 'LastName': 'Ueno', 'Affiliation': 'Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery, Kobe University Graduate School of Medicine, Hyogo, Japan.'}, {'ForeName': 'Motofumi', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery, Kobe University Graduate School of Medicine, Hyogo, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Kido', 'Affiliation': 'Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery, Kobe University Graduate School of Medicine, Hyogo, Japan.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Ajiki', 'Affiliation': 'Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery, Kobe University Graduate School of Medicine, Hyogo, Japan.'}, {'ForeName': 'Sae', 'Initials': 'S', 'LastName': 'Murakami', 'Affiliation': 'Clinical Translational Research Center of Kobe University Hospital, Hyogo, Japan.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Nishimura', 'Affiliation': 'Department of Preventive Medicine and Epidemiology, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Fukumoto', 'Affiliation': 'Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery, Kobe University Graduate School of Medicine, Hyogo, Japan.'}]",Annals of surgery,['10.1097/SLA.0000000000004072']
2077,32773634,"Comment on ""Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease: The SuPREMe-CD Study: A Randomized Clinical Trial"".",,2020,,"[""Crohn's Disease""]",[],[],"[{'cui': 'C0010346', 'cui_str': ""Crohn's disease""}]",[],[],,0.0988053,,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Department of General Surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University Hangzhou, China.'}]",Annals of surgery,['10.1097/SLA.0000000000004160']
2078,32773635,"Comment on ""Intracorporeal or Extracorporeal Ileocolic Anastomosis After Laparoscopic Right Colectomy. A Double-blinded Randomized Controlled Trial"".",,2020,,[],"['Laparoscopic Right Colectomy', 'Intracorporeal or Extracorporeal Ileocolic Anastomosis']",[],[],"[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0192861', 'cui_str': 'Right colectomy'}, {'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C0192751', 'cui_str': 'Ileocolic anastomosis'}]",[],,0.725542,,"[{'ForeName': 'Heather Caroline Mitchell', 'Initials': 'HCM', 'LastName': 'Pringle', 'Affiliation': 'Royal Devon and Exeter Hospital, Exeter, Devon, United Kingdom.'}, {'ForeName': 'George Edwin', 'Initials': 'GE', 'LastName': 'Fowler', 'Affiliation': ''}, {'ForeName': 'Robert Mackenzie', 'Initials': 'RM', 'LastName': 'Bethune', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004168']
2079,32773732,Effects of Cognitive Task Training on Dynamic Balance and Gait of Patients with Stroke: A Preliminary Randomized Controlled Study.,"BACKGROUND The decreased postural control ability of stroke patients affects their ability to balance in various postures such as sitting and standing. This study aimed to determine whether cognitive task training for stroke patients is effective in improving walking and balancing abilities. MATERIAL AND METHODS Seventeen stroke patients (10 males, 7 females) were randomized by ballot to be assigned to the cognitive task group (CBT) or the general task group (GBT). For the cognitive task training, a dual task of balance and cognition using traffic signals, a familiar form to the subjects, was applied as a program. In both groups the interventions were performed for 30 min a day, 3 times a week, for 4 weeks. The timed up and go test (TUG), the Berg balance scale (BBS), and gait ability evaluation were performed to compare the therapeutic effects. RESULTS After the intervention, the BBS showed significant differences in both groups (p<0.05). The cognitive task training group had significant improvement in all outcome scores after the intervention (p<0.05). The TUG score of the CBT group significantly decreased to 6.17 s (p<0.05), but that of the GBT showed no statistically significant change. CONCLUSIONS Cognitive task training could be used in clinical rehabilitation as a more effective intervention method to improve balance and gait ability of stroke patients.",2020,"The TUG score of the CBT group significantly decreased to 6.17 s (p<0.05), but that of the GBT showed no statistically significant change.","['Patients with Stroke', 'stroke patients', 'Seventeen stroke patients (10 males, 7 females']","['Cognitive task training', 'Cognitive Task Training', 'cognitive task group (CBT) or the general task group (GBT', 'cognitive task training']","['Berg balance scale (BBS), and gait ability evaluation', 'Dynamic Balance and Gait', 'postural control ability', 'TUG score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]","[{'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",17.0,0.0111076,"The TUG score of the CBT group significantly decreased to 6.17 s (p<0.05), but that of the GBT showed no statistically significant change.","[{'ForeName': 'Su-Yeon', 'Initials': 'SY', 'LastName': 'Hong', 'Affiliation': 'Department of Physical Therapy, Cheongju IM Rehabilitation Hospital, Cheongju, South Korea.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Moon', 'Affiliation': 'Department of Physical Therapy, The Graduate School, Daejeon University, Daejeon, South Korea.'}, {'ForeName': 'Jong-Duk', 'Initials': 'JD', 'LastName': 'Choi', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Daejeon, South Korea.'}]",Medical science monitor basic research,['10.12659/MSMBR.925264']
2080,32773737,Effects of different anesthesia and analgesia on cellular immunity and cognitive function of patients after surgery for esophageal cancer.,"OBJECTIVE


To analyze influences of different anesthesia and analgesia on cellular immune and cognitive functions of patients undergoing thoracotomy for esophageal cancer (EsC).
METHODS


Patients undergoing thoracotomy for EsC were divided into four groups: Group A (received general anesthesia (GA) and postoperative intravenous analgesia), B (received GA and postoperative epidural analgesia), C (received GA combined with thoracic epidural anesthesia (TEA) and postoperative intravenous analgesia), and D (received GA combined with TEA and postoperative epidural analgesia). The T-lymphocyte subsets were determined at 30 min before anesthesia induction (T0), 2 h after skin incision (T1), and at 4 h (T2), 24 h (T3), and 48 h (T4) after operation. Besides, visual analogue scale (VAS) and mini-mental state examination (MMSE) were assessed.
RESULTS


The percentage of CD3+ and CD4+ cells in Group B and C were higher than Group A from T1 to T3. The ratio of CD4+/CD8+ in Group B and C were higher than in Group A at T3. Compared with Group A, Group D had increased percentages of CD3+ and CD4+ from T1 to T4, and elevated ratio of CD4+/CD8+ from T2 to T4 VAS scores were lower and MMSE scores were higher in Group B, C, and D than in Group A, and Group D had relatively lower VAS and higher MMSE scores as compared to Group B.
CONCLUSIONS


The intraoperative general anesthesia combined with thoracic epidural anesthesia and postoperative epidural analgesia may reduce adverse effect on cellular immune and cognitive functions of patients undergoing thoracotomy for EsC.",2020,The percentage of CD3+ and CD4+ cells in Group B and C were higher than Group A from T1 to T3.,"['patients undergoing thoracotomy for esophageal cancer (EsC', 'patients after surgery for esophageal cancer', 'patients undergoing thoracotomy for EsC', 'Patients undergoing thoracotomy for EsC']","['general anesthesia (GA) and postoperative intravenous analgesia), B (received GA and postoperative epidural analgesia), C (received GA combined with thoracic epidural anesthesia (TEA) and postoperative intravenous analgesia), and D (received GA combined with TEA and postoperative epidural analgesia', 'thoracic epidural anesthesia and postoperative epidural analgesia', 'anesthesia and analgesia']","['cellular immunity and cognitive function', 'ratio of CD4+/CD8', 'visual analogue scale (VAS) and mini-mental state examination (MMSE', 'MMSE scores', 'elevated ratio of CD4+/CD8+ from T2 to T4 VAS scores', 'percentage of CD3+ and CD4+ cells', 'cellular immune and cognitive functions', 'CD3+ and CD4']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0002905', 'cui_str': 'Anesthesia and Analgesia'}]","[{'cui': 'C0020966', 'cui_str': 'Cell-Mediated Immunity'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C3251824', 'cui_str': 'Cell positive for CD4 antigen'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}]",,0.0510661,The percentage of CD3+ and CD4+ cells in Group B and C were higher than Group A from T1 to T3.,"[{'ForeName': 'Rongyu', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, Central Hospital of Enshi Autonomous Perfecture, Enshi, Hubei Province, P.R. China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xiang', 'Affiliation': 'Department of Anesthesiology, Central Hospital of Enshi Autonomous Perfecture, Enshi, Hubei Province, P.R. China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Tan', 'Affiliation': 'Department of Anesthesiology, Central Hospital of Enshi Autonomous Perfecture, Enshi, Hubei Province, P.R. China - tomorrow_dayt@163.com.'}]",Minerva chirurgica,['10.23736/S0026-4733.20.08283-8']
2081,32773834,Virtual Versus Paper-based Cases in Reinforcing the Collect and Assess Elements of the Pharmacists' Patient Care Process.,"Objective.  To compare pharmacy students' perceptions about and performance when using paper-based versus virtual patient cases to reinforce knowledge of the collect and assess elements of the Pharmacists' Patient Care Process  ( PPCP).  Methods.  Twenty-seven pharmacy students enrolled in an ambulatory care elective course were randomized to receive either paper-based cases or virtual patient cases for three weeks. They then crossed over to receive the alternative case format for the next three weeks. Each student received a score for their performance on questions related to the collect and assess elements of the PPCP. Students completed a survey and participated in a focus group to evaluate their perceptions of each learning method. Statistical analyses were performed on all data collected.  Results.  Students' performance (n=27) was better on the assess questions of the PPCP when they used paper-based patient cases than when they used virtual patient cases. The only difference in students' perceptions was related to the collect element, as students favored using paper-based patient cases over virtual patient cases when collecting subjective and objective information. Students who participated in the focus groups believed that the virtual patient cases provided a more realistic and engaging experience in addition to promoting critical thinking.  Conclusion.  While paper-based patient cases allowed pharmacy students to quickly identify and ""collect"" relevant information, increased use of virtual patient cases may enhance students' comfort level with and ability to ""assess"" actual patients.",2020,"The only difference in students' perceptions was related to the collect element, as students favored using paper-based patient cases over virtual patient cases when collecting subjective and objective information.","['Students who participated in the focus groups believed that the virtual patient cases', 'Twenty-seven pharmacy students enrolled in an ambulatory care elective course']",[],[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0038497', 'cui_str': 'Pharmacy Student'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]",[],[],27.0,0.0179624,"The only difference in students' perceptions was related to the collect element, as students favored using paper-based patient cases over virtual patient cases when collecting subjective and objective information.","[{'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Newsome', 'Affiliation': 'The University of Texas at Tyler, Fisch College of Pharmacy, Texas.'}, {'ForeName': 'Takova D', 'Initials': 'TD', 'LastName': 'Wallace-Gay', 'Affiliation': 'The University of Texas at Tyler, Fisch College of Pharmacy, Texas.'}, {'ForeName': 'Osama A', 'Initials': 'OA', 'LastName': 'Shoair', 'Affiliation': 'The University of Texas at Tyler, Fisch College of Pharmacy, Texas.'}]",American journal of pharmaceutical education,['10.5688/ajpe7806']
2082,32574418,Role of Terlipressin and Albumin for Hepatorenal Syndrome in Liver Transplantation.,"Hepatorenal syndrome (HRS) is one of the most ominous complications of portal hypertension in patients with decompensated cirrhosis and ascites. It is associated with very high mortality on the wait list. Liver transplantation (LT) is the most successful therapeutic option for patients with HRS. However, not all the LT candidates with HRS are able to receive a deceased donor allograft in a timely manner because it is a scarce resource and patients may need alternative best supportive treatment with systemic splanchnic vasoconstrictors and albumin as a bridge to transplant. The combination of terlipressin and albumin is efficacious in the reversal of HRS and is used worldwide. More recently, the multi-center, randomized, placebo-controlled double-blind study to confirm efficacy and safety of terlipressin in subjects with hepatorenal syndrome type 1 (The CONFIRM Study) trial demonstrated the efficacy of terlipressin and albumin in the reversal of HRS in a North American cohort. The aim of this article is to review the role of terlipressin and albumin in LT candidates with HRS in the United States.",2020,The combination of terlipressin and albumin is efficacious in the reversal of HRS and is used worldwide.,"['Hepatorenal Syndrome in Liver Transplantation', 'subjects with hepatorenal syndrome type 1', 'patients with decompensated cirrhosis and ascites', 'patients with HRS']","['Liver transplantation (LT', 'terlipressin and albumin', 'terlipressin', 'Terlipressin and Albumin', 'placebo']",['Hepatorenal syndrome (HRS'],"[{'cui': 'C0019212', 'cui_str': 'Hepatorenal syndrome'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}]","[{'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0145185', 'cui_str': 'terlipressin'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019212', 'cui_str': 'Hepatorenal syndrome'}]",,0.0877855,The combination of terlipressin and albumin is efficacious in the reversal of HRS and is used worldwide.,"[{'ForeName': 'Pratima', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Division of Gastroenterology and Hepatology, Michigan Medicine, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Moore', 'Affiliation': 'University College London Institute for Liver and Digestive Health, London, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ganger', 'Affiliation': 'Division of Gastroenterology and Hepatology, Northwestern Medicine, Chicago, IL.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Grewal', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mount Sinai Health System, New York, NY.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Brown', 'Affiliation': 'Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York, NY.'}]",Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society,['10.1002/lt.25834']
2083,32601378,COVID-19 among fit patients with CLL treated with venetoclax-based combinations.,,2020,,['patients with CLL treated with venetoclax-based combinations'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],[],,0.0235184,,"[{'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Fürstenau', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany. moritz.fuerstenau@uk-koeln.de.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Langerbeins', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'De Silva', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Fink', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Robrecht', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'von Tresckow', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Simon', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Hohloch', 'Affiliation': 'Department of Internal Medicine, Hematology and Medical Oncology, Kantonsspital Graubünden, Chur, Switzerland.'}, {'ForeName': 'Jolanda', 'Initials': 'J', 'LastName': 'Droogendijk', 'Affiliation': 'Division of Hematology and Oncology, Elisabeth-TweeSteden Ziekenhuis, Tilburg, The Netherlands.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'van der Klift', 'Affiliation': 'Division of Hematology and Oncology, Amphia Ziekenhuis Breda, Breda, The Netherlands.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'van der Spek', 'Affiliation': 'Department of Internal Medicine, Ziekenhuis Rijnstate, Arnhem, The Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Illmer', 'Affiliation': 'BAG Freiberg-Richter, Jacobasch, Wolf, Illmer, Dresden, Germany.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Schöttker', 'Affiliation': 'Hämatologisch-onkologische Schwerpunktpraxis Würzburg, Würzburg, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Clemens M', 'Initials': 'CM', 'LastName': 'Wendtner', 'Affiliation': 'Department of Hematology, Oncology, Immunology, Palliative Care, Infectious Diseases and Tropical Medicine, German CLL Study Group, Munich Clinic Schwabing, Munich, Germany.'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Tausch', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Carsten U', 'Initials': 'CU', 'LastName': 'Niemann', 'Affiliation': 'Department of Hematology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gregor', 'Affiliation': 'Division of Hematology, Cantonal Hospital of Lucerne, Lucerne, Switzerland.'}, {'ForeName': 'Arnon P', 'Initials': 'AP', 'LastName': 'Kater', 'Affiliation': 'Department of Hematology, Cancer Center Amsterdam, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Eichhorst', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany.'}]",Leukemia,['10.1038/s41375-020-0941-7']
2084,32657505,Sebelipase alfa for lysosomal acid lipase deficiency: 5-year treatment experience from a phase 2 open-label extension study.,"BACKGROUND AND AIMS


Lysosomal acid lipase deficiency is characterized by hepatomegaly and dyslipidaemia, which can lead to cirrhosis and premature atherosclerosis. Sebelipase alfa is an approved recombinant human lysosomal acid lipase. In an open-label extension study of adults with lysosomal acid lipase deficiency (LAL-CL04), sebelipase alfa treatment for 1 year reduced serum transaminase levels and liver fat content and improved serum lipid levels.
METHODS


Final data from LAL-CL04 are reported herein for patients who received sebelipase alfa infusions (1.0 or 3.0 mg/kg every other week) for up to 5 years.
RESULTS


Of 8 patients enrolled, 7 received sebelipase alfa for 224-260 weeks; 1 was lost to follow-up. Median baseline levels of alanine aminotransferase and aspartate aminotransferase (81.5 and 50.0 U/L, respectively) were decreased through the end-of-study visit (54.0 and 34.0 U/L). Median low-density lipoprotein cholesterol decreased from 113 to 78 mg/dL, total cholesterol decreased from 171 to 132 mg/dL, and high-density lipoprotein cholesterol increased from 37 to 42 mg/dL. Most treatment-emergent adverse events were nonserious (99%), mild/moderate (98%) and unrelated to sebelipase alfa (87%); no patient discontinued as a result of treatment-emergent adverse events. One patient had 2 serious treatment-emergent adverse events (cholecystitis and cholelithiasis; assessed as unlikely related to sebelipase alfa). Two patients had 20 nonserious infusion-associated reactions in weeks 6-38; all were manageable. One patient tested positive for antidrug antibodies (single occurrence).
CONCLUSIONS


Sebelipase alfa was well tolerated and improved serum transaminase and lipid levels for up to 5 years in adults with lysosomal acid lipase deficiency.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov record NCT01488097.",2020,"CONCLUSIONS


Sebelipase alfa was well tolerated and improved serum transaminase and lipid levels for up to 5 years in adults with lysosomal acid lipase deficiency.
","['adults with lysosomal acid lipase deficiency (LAL-CL04', 'adults with lysosomal acid lipase deficiency', 'Of 8 patients enrolled']","['Sebelipase alfa', 'sebelipase alfa infusions']","['Median baseline levels of alanine aminotransferase and aspartate aminotransferase', 'tolerated and improved serum transaminase and lipid levels', 'total cholesterol', 'high-density lipoprotein cholesterol', 'serum transaminase levels and liver fat content and improved serum lipid levels', 'Median low-density lipoprotein cholesterol']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043208', 'cui_str': ""Wolman's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4050579', 'cui_str': 'sebelipase alfa'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]",8.0,0.0400227,"CONCLUSIONS


Sebelipase alfa was well tolerated and improved serum transaminase and lipid levels for up to 5 years in adults with lysosomal acid lipase deficiency.
","[{'ForeName': 'Vĕra', 'Initials': 'V', 'LastName': 'Malinová', 'Affiliation': ""Department for Metabolic Diseases, Children's Clinic, General Faculty Hospital and First Faculty of Medicine of Charles University in Prague, Prague, Czech Republic.""}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Balwani', 'Affiliation': 'Department of Genetics and Genomic Sciences and Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Department of Endocrinology and Metabolic Medicine, Salford Royal Foundation NHS Trust, Salford, UK.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Arnoux', 'Affiliation': 'Department of Inherited Metabolic Diseases, Hôpital Necker-Enfants Malades, Paris, France.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kane', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Chester B', 'Initials': 'CB', 'LastName': 'Whitley', 'Affiliation': 'Advanced Therapies Program, and Gene Therapy Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Marulkar', 'Affiliation': 'Alexion Pharmaceuticals, Inc., Boston, MA, USA.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Abel', 'Affiliation': 'Alexion Pharmaceuticals, Inc., Boston, MA, USA.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14603']
2085,32014837,Haemodynamic support for cardiogenic shock and high-risk PCI: what can observational data tell us?,,2020,,['cardiogenic shock and high-risk PCI'],[],[],"[{'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]",[],[],,0.0230378,,"[{'ForeName': 'Ajay J', 'Initials': 'AJ', 'LastName': 'Kirtane', 'Affiliation': 'Columbia University Medical Center/NewYork-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY, USA.'}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJV15I15A239']
2086,30819817,Effect of daily azithromycin therapy and adherence on readmission risk in COPD.,,2019,,['COPD'],['azithromycin therapy'],['readmission risk'],"[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0137536,,"[{'ForeName': 'Jamuna K', 'Initials': 'JK', 'LastName': 'Krishnan', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Weill Cornell Medical College, Cornell University, New York NY, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Voelker', 'Affiliation': 'School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Connett', 'Affiliation': 'School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Dennis E', 'Initials': 'DE', 'LastName': 'Niewoehner', 'Affiliation': 'Pulmonary, Critical Care and Sleep Apnea, Minneapolis VA Health Care System and University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Albert', 'Affiliation': 'Pulmonary Sciences and Critical Care Medicine, University of Colorado, Denver, CO, USA.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Scanlon', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Dept of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University Hospital, Philadelphia, PA, USA.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Weill Cornell Medical College, Cornell University, New York NY, USA fjm2003@med.cornell.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The European respiratory journal,['10.1183/13993003.01377-2018']
2087,31580800,Multitarget Therapy: An Effective and Safe Therapeutic Regimen for Lupus Nephritis.,"INTRODUCTION


We evaluated the effectiveness and safety of various multitarget therapies for inducing remission in lupus nephritis patients.
METHODS


Randomized controlled trials (RCT) were identified and extracted from the Embase, PubMed, Chinese Biomedical Literature Database (CBM), and the Cochrane Library until Oct 31, 2018, investigations meeting inclusion criteria were extracted, and data were analyzed by meta-analysis. The total remission (TR; complete to partial remission), complete remission (CR), albumin, proteinuria levels, negative rate of anti-double-stranded DNA antibody (ds-DNA), negative rate of anti-nuclear antibody (ANA), and systemic lupus erythematosus disease activity index (SLE-DAI) were calculated using the software of RevMan 5.3.
RESULTS


Eleven RCTs were included and analyzed. The multitarget therapy group exhibited a higher value of CR (OR=3.06, 95%CI: 2.35-3.99, P﹤0.00001) as well as TR (OR=3.83, 95%CI: 2.77-5.31, P﹤0.00001) than those in the cyclophosphamide (CYC) group. In addition, multitarget therapies had more albumin (WMD=3.50, 95%CI: 1.04-5.95, P=0.005), greater albumin increases (OR=1.96, 95%CI: 0.63-3.29, P=0.004) and higher negative rates of ds-DNA (OR=2.13, 95%CI: 1.51-3.01, P﹤0.0001) and ANA (OR=2.82, 95%CI: 1.77-4.50, P﹤0.0001) when compared with the CYC group. This group also had less proteinuria levels (WMD=-0.55, 95%CI: -0.79 to -0.30, P﹤0.0001), lower degrees of SLE-DAI (OR=-1.80, 95%CI:-2.78 to -0.81, P=0.0004), and a lower adverse reaction rate. For example, gastrointestinal syndrome, irregular menstruation and leucopenia happened less frequently in the multitarget therapy group. However, hypertension was more prevalent in the multitarget therapy group.
CONCLUSIONS


Multitarget therapy is an effective and safe intervention for inducing remission in lupus nephritis patients.",2019,"OR=3.83, 95%CI: 2.77-5.31, P﹤0.00001) than those in the cyclophosphamide (CYC) group.","['Lupus Nephritis', 'lupus nephritis patients']","['Multitarget Therapy', 'cyclophosphamide (CYC', 'Multitarget therapy', 'various multitarget therapies', 'ANA']","['total remission (TR; complete to partial remission), complete remission (CR), albumin, proteinuria levels, negative rate of anti-double-stranded DNA antibody (ds-DNA), negative rate of anti-nuclear antibody (ANA), and systemic lupus erythematosus disease activity index (SLE-DAI', 'adverse reaction rate', 'value of CR', 'effectiveness and safety', 'SLE-DAI', 'greater albumin increases', 'proteinuria levels (WMD=-0.55, 95%CI', 'TR ', 'hypertension', 'negative rates of ds-DNA']","[{'cui': 'C0024143', 'cui_str': 'SLE glomerulonephritis syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0003243', 'cui_str': 'Antinuclear antibody'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1262035', 'cui_str': 'Measurement of deoxyribonucleoprotein antibody'}, {'cui': 'C0003243', 'cui_str': 'Antinuclear antibody'}, {'cui': 'C0451528', 'cui_str': 'Systemic lupus erythematosus disease activity index'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0740469', 'cui_str': 'Increased albumin'}, {'cui': 'C4517462', 'cui_str': '0.55'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",,0.212356,"OR=3.83, 95%CI: 2.77-5.31, P﹤0.00001) than those in the cyclophosphamide (CYC) group.","[{'ForeName': 'Tianbiao', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Department of Nephrology, the Second Affiliated Hospital, Shantou University Medical College, 515041, Shantou, Guangdong, China.'}, {'ForeName': 'Xialan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Wenshan', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Shujun', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': ''}]","Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques",['10.18433/jpps30526']
2088,32781283,Efficacy of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules in treatment of COVID-19: A randomized controlled trial.,"BACKGROUND


With the global epidemic of coronavirus disease (COVID-19), China has made progress in the prevention and control of the epidemic, and traditional Chinese medicine (TCM) has played a key role in dealing with the disease's effects on the respiratory system. This randomized controlled clinical trial evaluated the clinical efficacy and prognosis of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules in patients with COVID-19.
METHODS


A total of 283 patients participated in this clinical trial, and participants were randomly assigned to receive either 1) Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules or 2) Linahua granules, both combined with western medicine, or 3) western medicine alone for 14 days. At the end of the trial, the improvement and resolution rates of clinical symptoms and the rate of patients who progressed to severe disease status were evaluated.
RESULTS


After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05). Huoxiang Zhengqi dropping pills combined with Lianhua Qingwen granules has advantages in the treatment of nausea, vomiting and limb soreness. During treatment, all participants were treated with western medicine, and there was a significant difference in the use of macrolides among the three groups (P < 0.05). Specifically, the utilization rate of antibiotics in the western medicine group was significantly greater than that of the other two groups. Among the 182 diagnosed patients who completed this clinical trial, 13 patients progressed to severe disease, including one case in the Huoxiang + Lianhua group (1.6%), five cases in the Lianhua group (8.6%), and seven cases in the western medicine group (11.1%). There was no statistical differences in this rate among the three groups (P >  0.05). However, the proportion of patients who progressed to severe disease in the Huoxiang + Lianhua group was the lowest, suggesting that the combination of TCM with western medicine has a potential advantage in improving the prognosis of patients with COVID-19.
CONCLUSION


The use of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules combined with western medicine may have clinical advantages for COVID-19 patients in improving clinical symptoms, reducing utilization rate of anti-infective drugs, and improving patient prognosis, which could pave the way for the use of complementary medicine in treating this infection.",2020,"After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05).","['patients with COVID-19', 'COVID-19', '283 patients participated in this clinical trial, and participants', '182 diagnosed patients']","['Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules', 'Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules combined with western medicine']","['utilization rate of antibiotics', 'improvement rate of clinical symptoms', 'nausea, vomiting and limb soreness', 'severe disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C1871293', 'cui_str': 'Huoxiang-zhengqi'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",283.0,0.0509695,"After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05).","[{'ForeName': 'Mingzhong', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: xmz0001@sohu.com.'}, {'ForeName': 'Jiaxing', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China. Electronic address: tina_yai@126.com.'}, {'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: nana680@sina.com.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 510247444@qq.com.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Min', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: Mxj922@sohu.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 562163610@qq.com.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 719834165@qq.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, 10029, China. Electronic address: novelzhang@sina.com.'}, {'ForeName': 'Dengying', 'Initials': 'D', 'LastName': 'Yan', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: yandengying@outlook.com.'}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Lang', 'Affiliation': 'GCP ClinPlus Co., Ltd., Beijing, 100160, China. Electronic address: suping.lang@gcp-clinplus.com.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: r.e.x@163.com.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Fan', 'Affiliation': 'GCP ClinPlus Co., Ltd., Beijing, 100160, China. Electronic address: an.fan@gcp-clinplus.com.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Ke', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 24929135@qq.com.'}, {'ForeName': 'Xiuyang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: leexiuyang@126.com.""}, {'ForeName': 'Binbin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 291560898@qq.com.'}, {'ForeName': 'Manhong', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 43166472@qq.com.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 48302079@qq.com.'}, {'ForeName': 'Jinyue', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 627525649@qq.com.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 491193488@qq.com.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 87068066@qq.com.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zeng', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 309452513@qq.com.'}, {'ForeName': 'Chengyin', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 40691534@qq.com.'}, {'ForeName': 'Yujiao', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: luoyuorz@163.com.""}, {'ForeName': 'Haoran', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: dr-whr@foxmail.com.""}, {'ForeName': 'Jiaran', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: 502230253@qq.com.""}, {'ForeName': 'Fengmei', 'Initials': 'F', 'LastName': 'Lian', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: lfm565@sohu.com.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: Lixiaodong555@126.com.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Tong', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: tongxiaolin@vip.163.com.""}]",Pharmacological research,['10.1016/j.phrs.2020.105126']
2089,32781360,"Intrauterine administration of autologous hCG- activated peripheral blood mononuclear cells improves pregnancy outcomes in patients with recurrent implantation failure; A double-blind, randomized control trial study.","We aimed to investigate the effect of intrauterine administration of autologous hCG-activated PBMCs in RIF women with low Th-17/Treg cell ratio. 248 women with a history of implantation failure volunteered to receive PBMC-therapy. After immunologic consultation and doing flow cytometry analysis, 100 women with at least three IVF/ET failure who had low Th-17/Treg ratio in comparison with healthy control were enrolled in this study. These 100 patients were randomly divided into two groups as PBMC receiving (n = 50) and controls (n = 50). Then PBMCs were obtained from patients and treated with hCG for 48 h. Afterward, PBMCs were administered into the uterine cavity of the patient in the study group, two days before ET. The concentration of inflammatory cytokines was examined in the supernatant of cultured PBMCs after 2, 24, and 48 h of incubation using the ELISA method. The frequency of Th-17, Treg, and the Th-17/Treg ratio was significantly lower in RIF women than the healthy controls (P < 0.0001). The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001). The pregnancy and live birth rate were significantly increased in women undergoing the PBMC-therapy compared to control (PBS-injecting) group (P = 0.032 and P = 0.047, respectively). The miscarriage rate was considerably lower in PBMC-therapy group (P = 0.029). Our findings suggest that intrauterine administration of autologous in vitro hCG-activated PBMCs improves pregnancy outcomes in patients with at least three IVF/ET failures.",2020,The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001).,"['100 women with at least three IVF/ET failure who had low Th-17/Treg ratio in comparison with healthy control', 'patients with recurrent implantation failure', '100 patients', 'RIF women with low Th-17/Treg cell ratio', '248 women with a history of implantation failure volunteered to receive']","['hCG', 'autologous hCG-activated PBMCs', 'autologous hCG- activated peripheral blood mononuclear cells', 'PBMC-therapy']","['concentration of inflammatory cytokines', 'pregnancy and live birth rate', 'pregnancy outcomes', 'miscarriage rate', 'secretion of inflammatory cytokines', 'frequency of Th-17, Treg, and the Th-17/Treg ratio']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",248.0,0.138794,The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001).,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Pourmoghadam', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad Sadegh', 'Initials': 'MS', 'LastName': 'Soltani-Zangbar', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Golshan', 'Initials': 'G', 'LastName': 'Sheikhansari', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ramyar', 'Initials': 'R', 'LastName': 'Azizi', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Eghbal-Fard', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Mohammadi', 'Affiliation': 'Non-Communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Homayoon', 'Initials': 'H', 'LastName': 'Siahmansouri', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'Aghebati-Maleki', 'Affiliation': 'Immunology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Danaii', 'Affiliation': 'Gynecology Department, Eastern Azerbaijan ACECR ART center, Eastern Azerbaijan branch of ACECR, Tabriz, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Mehdizadeh', 'Affiliation': 'Endocrine Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hojjat-Farsangi', 'Affiliation': 'Department of Oncology-Pathology, Immune and Gene Therapy Lab, Cancer Center Karolinska (CCK), Karolinska University Hospital Solna and Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Roza', 'Initials': 'R', 'LastName': 'Motavalli', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Kidney Disease Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yousefi', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Kidney Disease Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: Yousefime@tbzmed.ac.ir.'}]",Journal of reproductive immunology,['10.1016/j.jri.2020.103182']
2090,32781371,A pragmatic randomised controlled trial of the fostering changes programme.,"BACKGROUND


Many looked after young people in Wales are cared for by foster or kinship carers, usually as a consequence of maltreatment or developmentally traumatising experiences within a family context. Confidence in Care is a pragmatic unblinded individually randomised controlled parallel group trial evaluating a training programme to improve foster carer self-efficacy, when compared to usual care.
OBJECTIVE


To determine whether group-based training improves foster carer self-efficacy.
PARTICIPANTS AND SETTING


Participants are foster carers, currently looking after children aged 2+ years for at least 12 weeks. Carers from households where one or more carer had previously attended the training were not eligible. Sixteen local authorities and three independent fostering providers in Wales took part.
METHODS


The primary outcome measure was the Carer Efficacy Questionnaire assessed at 12 months. Secondary outcomes included the Strengths and Difficulties Questionnaire, Quality of Attachment Questionnaire, Carer Defined Problems Scale, Carer Coping Strategies, placement moves.
RESULTS


312 consented foster carers were allocated to FC (n = 204) or usual care (n = 108) group. 65.3 % of FC group participants attended sufficient training sessions (8/12, including sessions three and four). There were no differences in carer-reported self-efficacy at 12 months (adjusted difference in means (95 % CI): -0.19 (-1.38 to 1.00)). Small differences in carer-reported child behaviour difficulties and carer coping strategies over time favoured the intervention but these effects diminished from three to 12 months. No other intervention effects were observed.
CONCLUSIONS


Although well-received by participants, training was associated with small and mostly short-term benefit for trial secondary outcomes.",2020,"Confidence in Care is a pragmatic unblinded individually randomised controlled parallel group trial evaluating a training programme to improve foster carer self-efficacy, when compared to usual care.
","['Participants are foster carers, currently looking after children aged 2+ years for at least 12 weeks', 'Sixteen local authorities and three independent fostering providers in Wales took part', '312 consented foster carers']","['usual care', 'FC']","['foster carer self-efficacy', 'carer-reported self-efficacy', 'Strengths and Difficulties Questionnaire, Quality of Attachment Questionnaire, Carer Defined Problems Scale, Carer Coping Strategies, placement moves', 'Carer Efficacy Questionnaire']","[{'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]",[],"[{'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",312.0,0.166724,"Confidence in Care is a pragmatic unblinded individually randomised controlled parallel group trial evaluating a training programme to improve foster carer self-efficacy, when compared to usual care.
","[{'ForeName': 'Gwenllian', 'Initials': 'G', 'LastName': 'Moody', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: MoodyG@cardiff.ac.uk.'}, {'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Coulman', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: JohnE1@cardiff.ac.uk.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Brookes-Howell', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: Brookes-HowellLC@cardiff.ac.uk.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Cannings-John', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: CanningsRL@cardiff.ac.uk.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Channon', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: ChannonS2@cardiff.ac.uk.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Lau', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: LauTM@cardiff.ac.uk.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Rees', 'Affiliation': ""Children's Social Care Research and Development Centre (CASCADE), School of Social Sciences, Cardiff University, United Kingdom, Wales. Electronic address: ReesA1@cardiff.ac.uk.""}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Segrott', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales; Centre for the Development and Evaluation of Complex Public Health Interventions for Public Health Improvement (DECIPHer), Cardiff University, United Kingdom, Wales. Electronic address: SegrottJ@cardiff.ac.uk.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Scourfield', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales; Centre for the Development and Evaluation of Complex Public Health Interventions for Public Health Improvement (DECIPHer), Cardiff University, United Kingdom, Wales. Electronic address: Scourfield@cardiff.ac.uk.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robling', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales; Centre for the Development and Evaluation of Complex Public Health Interventions for Public Health Improvement (DECIPHer), Cardiff University, United Kingdom, Wales. Electronic address: RoblingMR@cardiff.ac.uk.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104646']
2091,32781397,Parental sensitivity mediates the sustained effect of Attachment and Biobehavioral Catch-up on cortisol in middle childhood: A randomized clinical trial.,"IMPORTANCE


Parenting interventions have been found to normalize cortisol regulation among high-risk children early in development; it is important to investigate the sustainability of these effects and their mechanisms, given the maladaptive outcomes associated with cortisol dysregulation.
OBJECTIVE


To determine whether the Attachment and Biobehavioral Catch-up (ABC) intervention, implemented in infancy, predicts cortisol regulation in middle childhood via changes in early parental sensitivity.
DESIGN


Double blind randomized clinical trial design; started January 2006, the follow-up for this project concluded March 2016.
SETTING


Parents of children under age 2 referred from child protective services agencies in a large, mid-Atlantic city.
PARTICIPANTS


103 parent-child dyads (45.6% female children) with histories of child protective services involvement, randomly assigned to receive ABC (n = 45) or a control intervention (n = 58); in infancy, the children's ages ranged from 1.60 to 25.30 months (M = 9.87 months); at the middle childhood follow-up, they ranged from 8.0 to 11.0 years old (M = 8.52 years).
INTERVENTIONS


Both conditions included 10-week, in-home, manualized interventions. The experimental condition, ABC, has 3 primary targets for parents: increasing nurturance to child distress, increasing following the child's lead, and decreasing frightening behavior. The control intervention, Developmental Education for Families (DEF), is an adaptation of a program focused on enhancing cognitive and language development.
MAIN OUTCOMES AND MEASURES


Parental sensitivity was coded from a semi-structured interaction task between the parent and child in early childhood. Middle childhood diurnal cortisol slopes were modeled by collecting salivary cortisol samples from children at wake-up and bedtime over the course of 3 consecutive days.
RESULTS


ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002. The indirect effect of ABC on cortisol regulation via sensitivity was significant, β = -0.15, p = .038.
CONCLUSIONS AND RELEVANCE


ABC has an indirect effect on middle childhood diurnal cortisol regulation via parental sensitivity; future research should seek to determine how this enhanced neurobiological regulation relates to children's behavioral, socioemotional, and psychological outcomes.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT02093052.",2020,"RESULTS


ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002.","['Parents of children under age 2 referred from child protective services agencies in a large, mid-Atlantic city', ""n = 58); in infancy, the children's ages ranged from 1.60 to 25.30 months (M = 9.87 months); at the middle childhood follow-up, they ranged from 8.0 to 11.0 years old (M = 8.52 years"", 'middle childhood', '103 parent-child dyads (45.6% female children) with histories of child protective services involvement']","['control intervention, Developmental Education for Families (DEF', 'Attachment and Biobehavioral Catch-up (ABC) intervention', 'ABC', 'control intervention']","['Middle childhood diurnal cortisol slopes', 'cortisol regulation via sensitivity']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0681158', 'cui_str': 'Child Welfare Agencies'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0870604', 'cui_str': 'Female child'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0231617', 'cui_str': 'Catch'}]","[{'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.0395333,"RESULTS


ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002.","[{'ForeName': 'Mallory', 'Initials': 'M', 'LastName': 'Garnett', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States. Electronic address: mgarnett@udel.edu.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Bernard', 'Affiliation': 'Stony Brook University, Psychology B Building, Stony Brook, NY, 11794, United States.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hoye', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Zajac', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dozier', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104809']
2092,32781433,Promotion of Healthy Aging Within a Community Center Through Behavior Change: Health and Fitness Findings From the AgeWell Pilot Randomized Controlled Trial.,"The purpose of this randomized controlled trial was to determine if behavior change through individual goal setting (GS) could promote healthy aging, including health and fitness benefits in older adults who attended a community ""AgeWell"" Center for 12 months. Seventy-five older adults were randomly allocated to either a control or a GS group. Health outcomes were measured at baseline and after 12 months of the participants' having access to the exception of Agewell Center facilities. The findings demonstrate that participation in the Center in itself was beneficial, with improved body composition and reduced cardiovascular risk in both groups (p < .05), and that this kind of community-based resource offers valuable potential for promoting protective behaviors and reducing health risk. However, a specific focus on identifying individual behavior change goals was required in order to achieve increased activity engagement (p < .05) and to bring about more substantial improvements in a range of health, diet, and physical function measures (p < .05).",2020,"The findings demonstrate that participation in the Center in itself was beneficial, with improved body composition and reduced cardiovascular risk in both groups (p < .05), and that this kind of community-based resource offers valuable potential for promoting protective behaviors and reducing health risk.","['older adults who attended a community ""AgeWell"" Center for 12 months', 'Seventy-five older adults']",['individual goal setting (GS'],"['Health outcomes', 'body composition and reduced cardiovascular risk', 'activity engagement']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4319621', 'cui_str': '75'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",75.0,0.0605384,"The findings demonstrate that participation in the Center in itself was beneficial, with improved body composition and reduced cardiovascular risk in both groups (p < .05), and that this kind of community-based resource offers valuable potential for promoting protective behaviors and reducing health risk.","[{'ForeName': 'Jeanette M', 'Initials': 'JM', 'LastName': 'Thom', 'Affiliation': ''}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Nelis', 'Affiliation': ''}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Cooney', 'Affiliation': ''}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Hindle', 'Affiliation': ''}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Clare', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2019-0396']
2093,32781435,Effects of High-Intensity Interval Training in Hypoxia on Taekwondo Performance.,"PURPOSE


To evaluate the effects of a 6-week taekwondo-specific high-intensity interval training (HIIT) in simulated normobaric hypoxia on physical fitness and performance in taekwondoists.
METHODS


Eighteen male and female black-belt taekwondoists trained twice a week for 6 weeks in normoxia or in hypoxia (FiO2 = 0.143 O2). The HIIT was composed of specific taekwondo movements and simulated fights. Body composition analyses and a frequency speed of kick test during 10 seconds (FSKT10s) and 5 × 10 seconds (FSKTmult), countermovement jump (CMJ) test, Wingate test, and an incremental treadmill test were performed before and after training. Blood lactate concentrations were measured after the FSKTmult and Wingate tests, and a fatigue index during the tests was calculated.
RESULTS


A training effect was found for FSKT10s (+35%, P < .001), FSKTmult (+32%, P < .001), and fatigue index (-48%, P = .002). A training effect was found for CMJ height (+5%, P = .003) during the CMJ test. After training, CMJ height increased in hypoxia only (+7%, P = .005). No effect was found for the parameters measured during Wingate test. For the incremental treadmill test, a training effect was found for peak oxygen consumption (P = .002), the latter being 10% lower after than before training in normoxia only (P = .002).
CONCLUSIONS


In black-belt taekwondoists, hypoxic HIIT twice a week for 6 weeks provides tiny additional gains on key performance parameters compared with normoxic HIIT. Whether the trivial effects reported here might be of physiological relevance to improve performance remains debatable and should be tested individually.",2020,"For the incremental treadmill test, a training effect was found for peak oxygen consumption (P = .002), the latter being 10% lower after than before training in normoxia only (P = .002).
",['Eighteen male and female black-belt taekwondoists trained twice a week for 6 weeks in normoxia or in hypoxia (FiO2 = 0.143 O2'],"['High-Intensity Interval Training', 'taekwondo-specific high-intensity interval training (HIIT']","['Blood lactate concentrations', 'fatigue index', 'Taekwondo Performance', 'physical fitness and performance in taekwondoists', 'peak oxygen consumption', 'CMJ height', 'CMJ height increased in hypoxia', 'countermovement jump (CMJ) test, Wingate test, and an incremental treadmill test']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0452227', 'cui_str': 'Belt'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0557899', 'cui_str': 'Height increased'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0087110', 'cui_str': 'Treadmill Test'}]",18.0,0.0185523,"For the incremental treadmill test, a training effect was found for peak oxygen consumption (P = .002), the latter being 10% lower after than before training in normoxia only (P = .002).
","[{'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Chacón Torrealba', 'Affiliation': ''}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Aranda Araya', 'Affiliation': ''}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Benoit', 'Affiliation': ''}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Deldicque', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0668']
2094,32781440,A Combined Sleep Hygiene and Mindfulness Intervention to Improve Sleep and Well-Being During High-Performance Youth Tennis Tournaments.,"PURPOSE


To investigate the effects of combined sleep hygiene recommendations and mindfulness on actigraphy-based sleep parameters, perceptual well-being, anxiety, and match outcomes during high-performance junior tennis tournaments.
METHODS


In a randomized crossover design, 17 high-performance junior tennis players completed the baseline, control, and intervention (INT) conditions across 3 separate weeks. The baseline consisted of unassisted, habitual sleep during a regular training week, and the control was unassisted sleep during a tournament week. The players attended a sleep education workshop and completed a nightly sleep hygiene protocol during a tournament week for the INT. Analysis was performed on the weekly means and on the night prior to the first match of the tournament (T-1).
RESULTS


Significant differences were observed for increased time in bed, total sleep time, and an earlier bedtime (P < .05) across the INT week. These parameters also significantly improved on T-1 of the INT. A moderate effect size (P > .05, d > 1.00) was evident for decreased worry on T-1 of the INT. Small effect sizes were also evident for improved mood, cognitive anxiety, and sleep rating across the INT week. The match performance outcomes remained unchanged (P > .05).
CONCLUSIONS


Sleep hygiene INTs increase the sleep duration of high-performance junior tennis players in tournament settings, including the night prior to the tournament's first match. The effects on perceptual well-being and anxiety are unclear, although small trends suggest improved mood, despite no effect on generic match performance outcomes.",2020,"RESULTS


Significant differences were observed for increased time in bed, total sleep time, and an earlier bedtime (P < .05) across the INT week.","['17 high-performance junior tennis players completed the baseline, control, and intervention (INT) conditions across 3 separate weeks']","['Sleep Hygiene and Mindfulness Intervention', 'sleep education workshop and completed a nightly sleep hygiene protocol']","['time in bed, total sleep time, and an earlier bedtime', 'mood, cognitive anxiety, and sleep rating', 'actigraphy-based sleep parameters, perceptual well-being, anxiety, and match outcomes', 'sleep duration', 'T-1 of the INT', 'Sleep']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0039515', 'cui_str': 'Tennis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",17.0,0.0142361,"RESULTS


Significant differences were observed for increased time in bed, total sleep time, and an earlier bedtime (P < .05) across the INT week.","[{'ForeName': 'Jonathon R', 'Initials': 'JR', 'LastName': 'Lever', 'Affiliation': ''}, {'ForeName': 'Alistair P', 'Initials': 'AP', 'LastName': 'Murphy', 'Affiliation': ''}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Duffield', 'Affiliation': ''}, {'ForeName': 'Hugh H K', 'Initials': 'HHK', 'LastName': 'Fullagar', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-1008']
2095,32781441,How One Feels During Resistance Exercises: A Repetition-by-Repetition Analysis Across Exercises and Loads.,"CONTEXT


The Feeling Scale (FS) is a unique and underexplored scale in sport sciences that measures affective valence. The FS has the potential to be used in athletic environments as a monitoring and prescription tool.
PURPOSE


To examine whether FS ratings, as measured on a repetition-by-repetition basis, can predict proximity to task failure and bar velocity across different exercises and loads.
METHODS


On the first day, 20 trained participants (10 females) completed 1-repetition-maximum (1-RM) tests in the barbell bench and squat exercises and were introduced to the FS. In the following 3 sessions, participants completed 3 sets to task failure with either (1) 70% 1-RM bench press, (2) 70% 1-RM squat (squat-70%), or (3) 80% 1-RM squat (squat-80%). Sessions were completed in a randomized, counterbalanced order. After every completed repetition, participants verbally reported their FS ratings. Bar velocity was measured via a linear position transducer.
RESULTS


FS ratings predicted failure proximity and bar velocity in all 3 conditions (P < .001, R2 .66-.85). Based on the analysis, which included over 2400 repetitions, a reduction of 1 unit in the FS corresponded to approaching task failure by 14%, 11%, and 11%, and to a reduction in bar velocity of 10%, 4%, and 3%, in the bench, squat-70%, and squat-80%, respectively.
CONCLUSION


This is the first study to investigate whether the FS can be used in resistance-training environments among resistance-trained participants on a repetition-by-repetition basis. The results indicate that the FS can be used to monitor and prescribe resistance training and that its benefits should be further explored.",2020,"RESULTS


FS ratings predicted failure proximity and bar velocity in all 3 conditions (P < .001, R2 .66-.85).",['20 trained participants (10 females) completed'],"['Resistance Exercises', '1-repetition-maximum (1-RM) tests in the barbell bench and squat exercises and were introduced to the FS']","['Feeling Scale (FS', 'FS ratings', '1-RM squat', 'failure proximity and bar velocity', 'Bar velocity']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",20.0,0.0204185,"RESULTS


FS ratings predicted failure proximity and bar velocity in all 3 conditions (P < .001, R2 .66-.85).","[{'ForeName': 'Aviv', 'Initials': 'A', 'LastName': 'Emanuel', 'Affiliation': ''}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Rozen Smukas', 'Affiliation': ''}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Halperin', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0733']
2096,32781457,Addition of Fentanyl or High-Dose Morphine to Bupivacaine Is Superior to Bupivacaine Alone during Single-Shot Spinal Anesthesia.,"BACKGROUND


Single-shot spinal anesthesia (SSSA) with bupivacaine is a useful technique for pain control during the active phase of labor due to its simplicity and rapid onset. In this study, we evaluated the efficacy of the addition of fentanyl or high-dose morphine to bupivacaine during SSSA.
METHODS


Ninety healthy consecutive multiparous parturients in the active phase of progressing labor (cervical dilatation ≥7 cm; pain score >4) requesting analgesia were included in this study. The patients were randomly allocated into 3 SSSA groups as follows: group 1 (n = 30) receiving 2.5-mg hypobaric bupivacaine alone, group 2 (n = 30) receiving a combination of 2.5-mg hypobaric bupivacaine and 10-μg fentanyl, and group 3 (n = 30) receiving a combination of 2.5-mg hypobaric bupivacaine and 0.5-mg morphine. The duration of analgesia, VAS scores, side effects, and obstetric and neonatal outcomes were compared.
RESULTS


The main gestational age and cervical dilatation of the patients were 38.7 ± 1.5 months and 7.2 ± 2.2 cm (p = 0.14 and p = 0.65), respectively. The main VAS score significantly decreased in all groups at 3 h from baseline: from 8.25 to 1.75 in group 1, from 7.61 to 1.28 in group 2, and from 8.12 to 1.26 in group 3 (p < 0.001). The duration of the second phase of delivery was similar in all groups (45.5, 44, and 38 min, respectively; p = 0.67). The total analgesia duration was significantly higher in group 3 (172, 180, and 190 min for groups 1, 2, and 3, respectively; p = 0.01). The Apgar scores and fetal heart rates were similar in all groups (p = 0.95). Side effects were similar, except for pruritus in group 3 (p = 0.01).
CONCLUSION


The addition of fentanyl or high-dose morphine to bupivacaine increases the efficacy and duration of SSSA in the active phase of progressing labor without increasing side effects.",2020,"The total analgesia duration was significantly higher in group 3 (172, 180, and 190 min for groups 1, 2, and 3, respectively; p = 0.01).",['Ninety healthy consecutive multiparous parturients in the active phase of progressing labor (cervical dilatation ≥7 cm; pain score >4) requesting analgesia were included in this study'],"['Fentanyl or High-Dose Morphine', 'Bupivacaine', 'bupivacaine', 'SSSA', 'fentanyl or high-dose morphine', '2.5-mg hypobaric bupivacaine alone, group 2 (n = 30) receiving a combination of 2.5-mg hypobaric bupivacaine and 10-μg fentanyl, and group 3 (n = 30) receiving a combination of 2.5-mg hypobaric bupivacaine and 0.5-mg morphine']","['duration of the second phase of delivery', 'total analgesia duration', 'duration of analgesia, VAS scores, side effects, and obstetric and neonatal outcomes', 'efficacy and duration of SSSA', 'main VAS score', 'Side effects', 'Apgar scores and fetal heart rates']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0026751', 'cui_str': 'Multiparous'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}]",90.0,0.0811958,"The total analgesia duration was significantly higher in group 3 (172, 180, and 190 min for groups 1, 2, and 3, respectively; p = 0.01).","[{'ForeName': 'Bilge', 'Initials': 'B', 'LastName': 'Aslan', 'Affiliation': 'Department of Anesthesia and Reanimation, Zekai Tahir Burak Training and Research Hospital, University of Health Sciences, Ankara, Turkey, drbilgeaslan@hotmail.com.'}, {'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Moraloğlu', 'Affiliation': 'Department of Obstetrics, Zekai Tahir Burak Training and Research Hospital, University of Health Sciences, Ankara, Turkey.'}]",Gynecologic and obstetric investigation,['10.1159/000509513']
2097,32781476,Ergogenic Effects of Bihemispheric Transcranial Direct Current Stimulation on Fitness: a Randomized Cross-over Trial.,"Several types of routines and methods have been experimented to gain neuromuscular advantages, in terms of exercise performance, in athletes and fitness enthusiasts. The aim of the present study was to evaluate the impact of biemispheric transcranial direct current stimulation on physical fitness indicators of healthy, physically active, men. In a randomized, single-blinded, crossover fashion, seventeen subjects (age: 30.9 ± 6.5 years, BMI: 24.8±3.1 kg/m2) underwent either stimulation or sham, prior to: vertical jump, sit & reach, and endurance running tests. Mixed repeated measures anova revealed a large main effect of stimulation for any of the three physical fitness measures. Stimulation determined increases of lower limb power (+ 5%), sit & reach amplitude (+ 9%) and endurance running capacity (+ 12%) with respect to sham condition (0.16<ηp2 < 0.41; p<0.05). Ratings-of-perceived-exertion, recorded at the end of each test session, did not change across all performances. However, in the stimulated-endurance protocol, an average lower rate-of-perceived-exertion at iso-time was inferred. A portable transcranial direct current stimulation headset could be a valuable ergogenic resource for individuals seeking to improve physical fitness in daily life or in athletic training.",2020,"Stimulation determined increases of lower limb power (+ 5%), sit & reach amplitude (+ 9%) and endurance running capacity (+ 12%) with respect to sham condition (0.16<ηp2 < 0.41; p<0.05).","['seventeen subjects (age: 30.9\u2009± 6.5 years, BMI: 24.8±3.1 kg/m2) underwent either', 'Fitness', 'healthy, physically active, men']","['portable transcranial direct current stimulation headset', 'Bihemispheric Transcranial Direct Current Stimulation', 'biemispheric transcranial direct current stimulation', 'stimulation or sham, prior to: vertical jump, sit & reach, and endurance running tests']","['lower limb power', 'endurance running capacity', 'sit & reach amplitude']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}]",17.0,0.10778,"Stimulation determined increases of lower limb power (+ 5%), sit & reach amplitude (+ 9%) and endurance running capacity (+ 12%) with respect to sham condition (0.16<ηp2 < 0.41; p<0.05).","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Codella', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Alongi', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Filipas', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Livio', 'Initials': 'L', 'LastName': 'Luzi', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milano, Italy.'}]",International journal of sports medicine,['10.1055/a-1198-8525']
2098,32781512,Effects of Kinesiology Taping on Shoulder Posture and Peak Torque in Junior Baseball Players with Rounded Shoulder Posture: A Pilot Study.,"Rounded shoulder posture (RSP) causes an imbalance of the adjacent joints due to the malalignment of the shoulder joint, and thus affects the strength of the muscles surrounding the shoulder. This study aimed to investigate the effect of rounded shoulder taping (RST) on shoulder posture and muscle strength in junior baseball players. Nineteen junior baseball players participated in the study, which used a crossover design at an interval of 1 week. The participants were randomized to receive rounded shoulder taping (RST) and sham kinesiology taping (SKT) using kinesiology tape. RSP was measured using two 12-inch combination squares, and shoulder peak torques were measured by isokinetic equipment. The results showed that RST led to significant changes in RSP ( p  < 0.05), but no significant changes were observed with SKT ( p  < 0.05). RST led to significant changes in the peak torques of external rotation and internal rotation of the shoulder ( p  < 0.05), but no significant changes were observed with SKT ( p  < 0.05). These results suggest that RST could help to correct RSP and improve peak torque of external and internal rotation of the shoulders of junior baseball players with RSP.",2020,"RST led to significant changes in the peak torques of external rotation and internal rotation of the shoulder ( p  < 0.05), but no significant changes were observed with SKT ( p  < 0.05).","['junior baseball players', 'Junior Baseball Players with Rounded Shoulder Posture', 'Nineteen junior baseball players']","['RST', 'Rounded shoulder posture (RSP', 'rounded shoulder taping (RST) and sham kinesiology taping (SKT) using kinesiology tape', 'Kinesiology Taping', 'rounded shoulder taping (RST']","['peak torque of external and internal rotation', 'peak torques of external rotation and internal rotation of the shoulder', 'shoulder peak torques', 'shoulder posture and muscle strength', 'RSP', 'Shoulder Posture and Peak Torque']","[{'cui': 'C0004795', 'cui_str': 'Baseball'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}]",,0.0476494,"RST led to significant changes in the peak torques of external rotation and internal rotation of the shoulder ( p  < 0.05), but no significant changes were observed with SKT ( p  < 0.05).","[{'ForeName': 'Hyeong-Geun', 'Initials': 'HG', 'LastName': 'Yun', 'Affiliation': 'Department of Biomedical Health Science, Graduate School, Dong-Eui University, Busan 47340, Korea.'}, {'ForeName': 'Jung-Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, College of Nursing, Healthcare Sciences and Human Ecology, Dong-Eui University, Busan 47340, Korea.'}, {'ForeName': 'Im-Rak', 'Initials': 'IR', 'LastName': 'Choi', 'Affiliation': 'Department of Rehabilitation Therapy Team, Sports Exercise Therapy Center, Good Samsun Hospital, Busan 47007, Korea.'}]","Life (Basel, Switzerland)",['10.3390/life10080139']
2099,32781869,Serial locally applied water-filtered infrared a radiation in axial spondyloarthritis - a randomized controlled trial.,"INTRODUCTION


Aim of this randomized controlled trial was to evaluate the effects of serial locally applied water-filtered infrared A radiation (sl-wIRAR) in patients with axial spondyloarthritis (axSpA).
METHODS


axSpA patients with active disease undergoing a 7-day multimodal rheumatologic complex treatment under non-steroidal anti-inflammatory drug (NSAID) therapy were eligible. Patients were randomly assigned in a 1:1 ratio. The intervention group (IG) received additional sl-wIRAR treatment of the back (2 treatments for 30 min per day for 6 days) to assess whether locally applied hyperthermia can i) reduce pain levels, ii) reduce disease activity and improve functionality and iii) whether an effect on tumor necrosis factor α (TNFα) levels is detectable. Additionally, it was examined whether a reduction in NSAID therapy could be achieved after trial completion.
RESULTS


71 patients completed the trial (IG: 36 patients, control group (CG) 35 patients). sl-wIRAR led to a significant pain reduction measured by a numeric rating scale ( p  < .0005) and in comparison, to the CG ( p  = .006). sl-wIRAR treatment resulted in a significant reduction in the Bath Anyklosing Spondylitis Disease Activity Index (BASDAI) ( p  = .004) and Bath Ankylosing Spondylitis Functional Index ( p  = .004) with no significant difference to the CG. TNF-α levels were significantly decreased ( p  = .001) only in the IG with a significant difference to the CG ( p  = .01). 26 (76%) of patients in the IC reduced their NSAID therapy after trial completion.
CONCLUSION


sl-wIRAR treatment in axSpA leads to a rapid reduction in pain allowing NSAID dosage reduction. A reason for these desirable effects could be a change in TNFα levels.",2020,"sl-wIRAR led to a significant pain reduction measured by a numeric rating scale ( p  < .0005) and in comparison, to the CG ( p  = .006).","['axSpA patients with active disease undergoing a 7-day multimodal rheumatologic complex treatment under non-steroidal anti-inflammatory drug (NSAID) therapy were eligible', '71 patients completed the trial (IG: 36 patients, control group (CG) 35 patients', 'patients with axial spondyloarthritis (axSpA']","['serial locally applied water-filtered infrared A radiation (sl-wIRAR', 'additional sl-wIRAR', 'Serial locally applied water-filtered infrared a radiation']","['pain levels, ii) reduce disease activity and improve functionality and iii) whether an effect on tumor necrosis factor α (TNFα) levels', 'pain reduction', 'TNF-α levels', 'numeric rating scale', 'Bath Ankylosing Spondylitis Functional Index', 'TNFα levels', 'Bath Anyklosing Spondylitis Disease Activity Index (BASDAI']","[{'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038012', 'cui_str': 'Spondylitis'}, {'cui': 'C1998004', 'cui_str': 'Bath ankylosing spondylitis disease activity index'}]",,0.101196,"sl-wIRAR led to a significant pain reduction measured by a numeric rating scale ( p  < .0005) and in comparison, to the CG ( p  = .006).","[{'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Klemm', 'Affiliation': 'Department of Rheumatology, Immunology, Osteology and Physical Medicine, Campus Kerckhoff, Justus-Liebig-University Gießen, Bad Nauheim, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Eichelmann', 'Affiliation': 'Department of Rheumatology, Immunology, Osteology and Physical Medicine, Campus Kerckhoff, Justus-Liebig-University Gießen, Bad Nauheim, Germany.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Aykara', 'Affiliation': 'Department of Rheumatology, Immunology, Osteology and Physical Medicine, Campus Kerckhoff, Justus-Liebig-University Gießen, Bad Nauheim, Germany.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Hudowenz', 'Affiliation': 'Department of Rheumatology, Immunology, Osteology and Physical Medicine, Campus Kerckhoff, Justus-Liebig-University Gießen, Bad Nauheim, Germany.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Dischereit', 'Affiliation': 'Department of Rheumatology, Immunology, Osteology and Physical Medicine, Campus Kerckhoff, Justus-Liebig-University Gießen, Bad Nauheim, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Lange', 'Affiliation': 'Department of Rheumatology, Immunology, Osteology and Physical Medicine, Campus Kerckhoff, Justus-Liebig-University Gießen, Bad Nauheim, Germany.'}]","International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group",['10.1080/02656736.2020.1804079']
2100,32781894,Conventional versus minimally invasive extracorporeal circulation in patients undergoing cardiac surgery: protocol for a randomised controlled trial (COMICS).,"INTRODUCTION


Despite low mortality, cardiac surgery patients may experience serious life-threatening post-operative complications, often due to extracorporeal circulation and reperfusion. Miniaturised cardiopulmonary bypass (minimally invasive extracorporeal circulation) has been developed aiming to reduce the risk of post-operative complications arising with conventional extracorporeal circulation.
METHODS


The COMICS trial is a multi-centre, international, two-group parallel randomised controlled trial testing whether type II, III or IV minimally invasive extracorporeal circulation is effective and cost-effective compared to conventional extracorporeal circulation in patients undergoing elective or urgent coronary artery bypass grafting, aortic valve replacement or coronary artery bypass grafting + aortic valve replacement. Randomisation (1:1 ratio) is concealed and stratified by centre and surgical procedure. The primary outcome is a composite of 12 serious complications, objectively defined or adjudicated, 30 days after surgery. Secondary outcomes (at 30 days) include other serious adverse events (primary safety outcome), use of blood products, length of intensive care and hospital stay and generic health status (also at 90 days).
STATUS OF THE TRIAL


Two centres started recruiting on 08 May 2018; 10 are currently recruiting and 603 patients have been randomised (11 May 2020). The recruitment rate from 01 April 2019 to 31 March 2020 was 40-50 patients/month. About 80% have had coronary artery bypass grafting only. Adherence to allocation is good.
CONCLUSIONS


The trial is feasible but criteria for progressing to a full trial were not met on time. The Trial Steering and Data Monitoring Committees have recommended that the trial should currently continue.",2020,"Miniaturised cardiopulmonary bypass (minimally invasive extracorporeal circulation) has been developed aiming to reduce the risk of post-operative complications arising with conventional extracorporeal circulation.
","['patients undergoing elective or urgent coronary artery bypass grafting, aortic valve replacement or coronary artery bypass grafting\u2009+\u2009aortic valve replacement', 'patients undergoing cardiac surgery', 'Two centres started recruiting on 08 May 2018; 10 are currently recruiting and 603 patients have been randomised (11 May 2020']","['Conventional versus minimally invasive extracorporeal circulation', 'Miniaturised cardiopulmonary bypass (minimally invasive extracorporeal circulation', 'conventional extracorporeal circulation']","['composite of 12 serious complications', 'serious adverse events (primary safety outcome), use of blood products, length of intensive care and hospital stay and generic health status (also at 90\u2009days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0303135', 'cui_str': 'Beryllium-10'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0015354', 'cui_str': 'Extracorporeal circulation procedure'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0456388', 'cui_str': 'Blood product'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.169333,"Miniaturised cardiopulmonary bypass (minimally invasive extracorporeal circulation) has been developed aiming to reduce the risk of post-operative complications arising with conventional extracorporeal circulation.
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Perfusion,['10.1177/0267659120946731']
2101,32781895,Retrieval-induced forgetting in a social task.,"Clinical researchers suggest that post-event thinking functions to negatively bias event recall for socially anxious participants. We used a repeated retrieval paradigm to examine the effects of post-event retrieval on memory for social information. Undergraduate participants ( n  = 214) engaged in an impromptu public speaking task and received a standardised mixture of positive and negative feedback on their speech. Participants in the experimental condition were instructed to repeatedly retrieve the negative feedback items whereas participants in the control condition completed a control task. Both groups were asked to recall the feedback after five minutes and after one week. Results indicated that the experimental group displayed the hypothesised retrieval-induced forgetting effect. In addition, repeated retrieval predicted valence change in that participants recalled the non-retrieved positive feedback items less positively over time. The retrieval-practice effects were distinct from self-reported post-event processing. Contrary to clinical theories, social anxiety did not moderate retrieval-induced forgetting or recall bias. Instead, all participants displayed retrieval-related negatively biased recall.",2020,"Contrary to clinical theories, social anxiety did not moderate retrieval-induced forgetting or recall bias.","['socially anxious participants', 'Undergraduate participants ( n \u2009=\u2009214']",['engaged in an impromptu public speaking task and received a standardised mixture of positive and negative feedback on their speech'],['hypothesised retrieval-induced forgetting effect'],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0223234,"Contrary to clinical theories, social anxiety did not moderate retrieval-induced forgetting or recall bias.","[{'ForeName': 'Brianne L', 'Initials': 'BL', 'LastName': 'Glazier', 'Affiliation': 'Department of Psychology, University of British Cozlumbia, Vancouver, BC, Canada.'}, {'ForeName': 'Lynn E', 'Initials': 'LE', 'LastName': 'Alden', 'Affiliation': 'Department of Psychology, University of British Cozlumbia, Vancouver, BC, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Graf', 'Affiliation': 'Department of Psychology, University of British Cozlumbia, Vancouver, BC, Canada.'}]",Cognition & emotion,['10.1080/02699931.2020.1806042']
2102,32781898,Promoting the Community's Ability to Detect and Respond to Suicide Risk Through an Online Bystander Intervention Model-Informed Tool.,"Background:  The public health sector has advocated for more innovative, technology-based, suicide prevention education for the community, to improve their ability to detect and respond to suicide risk. Emerging evidence suggests addressing the bystander effect through the Bystander Intervention Model (BIM) in education material may have potential for suicide prevention.  Aims:  The current study aimed to assess whether BIM-informed tools can lead to improved readiness, confidence and intent in the community to detect and respond to suicide risk in others.  Method:  A sample of 281 adults recruited from the community participated in a randomized controlled trial comprising a factsheet designed according to the BIM (intervention group) and a standard factsheet about suicide and mental health (control group). Participants' self-reported detecting and responding to suicide risk readiness, confidence, and intent when presented with a suicidal peer was tested pre- and postintervention and compared across time and between groups.  Results:  The intervention group had significantly higher levels of detecting and responding to suicide risk readiness, confidence, and intent than the control group at postintervention (all  p  < .001) with moderate-to-large effect sizes.  Limitations:  The study was limited by a homogenous sample, too low numbers at follow-up to report, and self-report data only.  Conclusion:  This study demonstrates BIM-informed suicide prevention training may enhance the community's intervention readiness, confidence, and intent better than current standard material. Further testing in this area is recommended. While results were statistically significant, clinical significance requires further exploration.",2020,"The intervention group had significantly higher levels of detecting and responding to suicide risk readiness, confidence, and intent than the control group at postintervention (all  p  < .001) with moderate-to-large effect sizes.  ",['281 adults recruited from the community participated'],['standard factsheet about suicide and mental health (control group'],['higher levels of detecting and responding to suicide risk readiness'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0563664', 'cui_str': 'At risk for suicide'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}]",281.0,0.0543087,"The intervention group had significantly higher levels of detecting and responding to suicide risk readiness, confidence, and intent than the control group at postintervention (all  p  < .001) with moderate-to-large effect sizes.  ","[{'ForeName': 'Karien', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': 'Department of Psychology and Public Health, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Somerset', 'Affiliation': 'Department of Public Health, University of Canberra, Australia.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Schwarzer', 'Affiliation': 'Department of Health Psychology, Free University of Berlin, Germany.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Chan', 'Affiliation': 'Department of Psychology and Public Health, La Trobe University, Melbourne, VIC, Australia.'}]",Crisis,['10.1027/0227-5910/a000708']
2103,32775822,Assessing the Impact of Losmapimod on Proteinuria in Idiopathic Focal Segmental Glomerulosclerosis.,"Introduction


Idiopathic focal segmental glomerulosclerosis (FSGS) is a leading cause of nephrotic syndrome and end-stage renal disease. In preclinical models and biopsies of human FSGS kidneys, p38 mitogen-activated protein kinase (MAPK) has demonstrated enhanced activity; and p38 MAPK inhibition has improved disease markers. This proof-of-concept trial aimed to assess efficacy, safety, tolerability, and pharmacokinetics of losmapimod, an oral p38 MAPK inhibitor, in humans with FSGS.
Methods


A single-arm, multicenter, open-label, Phase II trial (NCT02000440) was conducted in adults with FSGS; proteinuria ≥2.0 g/d; estimated glomerular filtration rate (eGFR) ≥45 ml/min per 1.73 m 2 ; blood pressure <140/90 mm Hg. Collapsing and genetic forms of FSGS were excluded. The primary endpoint was number of patients with ≥50% proteinuria reduction and eGFR ≥70% of baseline after receiving losmapimod twice-daily for 16 to 24 weeks.
Results


Seventeen patients received ≥1 losmapimod dose. No patients achieved the primary endpoint; therefore, the study was terminated following a prespecified interim analysis. At week 24, proteinuria reductions between 20% and <50% were observed in 4 patients and proteinuria increases >20% in 3 patients. One patient achieved a proteinuria response (≥50% reduction) at week 2 but subsequently relapsed. Losmapimod pharmacokinetics were consistent with prior studies. No serious adverse events (AEs) were reported.
Conclusion


p38 MAPK inhibition with losmapimod did not result in ≥50% reduction of proteinuria in patients with FSGS. However, study population heterogeneity may have contributed to our negative findings and therefore this does not eliminate the potential to demonstrate benefit in a population more sensitive to p38 MAPK inhibition if identifiable in the future by precision-medicine methods.",2020,"Conclusion


p38 MAPK inhibition with losmapimod did not result in ≥50% reduction of proteinuria in patients with FSGS.","['patients with FSGS', 'humans with FSGS', 'adults with FSGS; proteinuria\xa0≥2.0 g/d; estimated glomerular filtration rate (eGFR)\xa0≥45 ml/min per 1.73 m 2 ; blood pressure\xa0<140/90 mm\xa0Hg', 'Idiopathic Focal Segmental Glomerulosclerosis']",[],"['efficacy, safety,\xa0tolerability, and pharmacokinetics', 'proteinuria reductions', 'number of patients with\xa0≥50% proteinuria reduction and eGFR', 'proteinuria response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017668', 'cui_str': 'Focal glomerular sclerosis'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}]",[],"[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]",50.0,0.088704,"Conclusion


p38 MAPK inhibition with losmapimod did not result in ≥50% reduction of proteinuria in patients with FSGS.","[{'ForeName': 'Debbie S', 'Initials': 'DS', 'LastName': 'Gipson', 'Affiliation': 'Department of Pediatrics, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Hladunewich', 'Affiliation': 'Department of Internal Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lafayette', 'Affiliation': 'Department of Internal Medicine, Stanford University, Stanford, California, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Sedor', 'Affiliation': 'Department of Internal Medicine, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Brad H', 'Initials': 'BH', 'LastName': 'Rovin', 'Affiliation': 'Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus, Ohio, USA.'}, {'ForeName': 'Sean J', 'Initials': 'SJ', 'LastName': 'Barbour', 'Affiliation': 'Department of Internal Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'McMahon', 'Affiliation': 'Department of Internal Medicine, University of Alberta Hospital, Edmonton, Alberta, Canada.'}, {'ForeName': 'J Charles', 'Initials': 'JC', 'LastName': 'Jennette', 'Affiliation': 'Department of Pathology, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Patrick H', 'Initials': 'PH', 'LastName': 'Nachman', 'Affiliation': 'Department of Internal Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Robert N', 'Initials': 'RN', 'LastName': 'Willette', 'Affiliation': 'PoC Pharma Consulting, LLC, Pottstown, Pennsylvania, USA.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Paglione', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Jorge Alfonso', 'Initials': 'JA', 'LastName': 'Ross Terres', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Vallow', 'Affiliation': 'Worldwide Clinical Trials, Morrisville, North Carolina, USA.'}, {'ForeName': 'M Claire', 'Initials': 'MC', 'LastName': 'Holland', 'Affiliation': 'Teva Pharmaceuticals, Frazer, Pennsylvania, USA.'}, {'ForeName': 'Kevin S', 'Initials': 'KS', 'LastName': 'Thorneloe', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Dennis L', 'Initials': 'DL', 'LastName': 'Sprecher', 'Affiliation': 'BioView Consultants, LLC, Blue Bell, Pennsylvania, USA.'}]",Kidney international reports,['10.1016/j.ekir.2020.05.024']
2104,32775825,Supervised Exercise Intervention and Overall Activity in CKD.,"Introduction


Patients are often instructed to engage in multiple weekly sessions of exercise to increase physical activity. We aimed to determine whether assignment to a supervised exercise regimen increases overall weekly activity in individuals with chronic kidney disease (CKD).
Methods


We performed a secondary analysis of a pilot randomized 2 × 2 factorial design trial examining the effects of diet and exercise (10%-15% reduction in caloric intake, 3 supervised exercise sessions/wk, combined diet restriction/exercise, and control). Activity was measured as counts detected by accelerometer. Counts data were collected on all days for which an accelerometer was worn at baseline, month 2, and month 4 follow-up. The primary outcome was a relative change from baseline in log-transformed counts/min. Generalized estimating equations were used to compare the primary outcome in individuals in the exercise group and the nonexercise group.
Results


We examined 111 individuals randomized to aerobic exercise or usual activity (n = 48 in the exercise group and n = 44 controls). The mean age was 57 years, 42% were female, and 28% were black. Median overall adherence over all time was 73%. Median (25th, 75th percentile) counts/min over nonsupervised exercise days at months 2 and 4 were 237.5 (6.5, 444.4) for controls and 250.9 (7.7, 529.8) for the exercise group ( P  = 0.74). No difference was observed in the change in counts/min between the exercise and control groups over 3 time points (β [fold change], 0.96, 95% confidence interval [CI], 0.91, 1.02).
Conclusion


Engaging in a supervised exercise program does not increase overall weekly physical activity in individuals with stage 3 to 4 CKD.",2020,"No difference was observed in the change in counts/min between the exercise and control groups over 3 time points (β [fold change], 0.96, 95% confidence interval [CI], 0.91, 1.02).
","['individuals with stage 3 to 4 CKD', '111 individuals randomized to', 'individuals with chronic kidney disease (CKD', 'The mean age was 57 years, 42% were female, and 28% were black', 'n\xa0= 48 in the exercise group and n\xa0= 44 controls']","['diet and exercise', 'aerobic exercise or usual activity', 'supervised exercise regimen', 'supervised exercise program', 'Supervised Exercise Intervention']","['Activity', 'relative change from baseline in log-transformed counts/min', 'Median overall adherence', 'overall weekly physical activity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",111.0,0.116624,"No difference was observed in the change in counts/min between the exercise and control groups over 3 time points (β [fold change], 0.96, 95% confidence interval [CI], 0.91, 1.02).
","[{'ForeName': 'Mindy M', 'Initials': 'MM', 'LastName': 'Pike', 'Affiliation': ""Vanderbilt O'Brien Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.""}, {'ForeName': 'Aseel', 'Initials': 'A', 'LastName': 'Alsouqi', 'Affiliation': ""Vanderbilt O'Brien Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.""}, {'ForeName': 'Samuel A E', 'Initials': 'SAE', 'LastName': 'Headley', 'Affiliation': 'Department of Exercise Science and Athletic Training, Springfield College, Springfield, Massachusetts, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Tuttle', 'Affiliation': 'Kidney Research Institute, Division of Nephrology, Department of Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Elizabeth Elspeth', 'Initials': 'EE', 'LastName': 'Evans', 'Affiliation': 'Department of Exercise Science and Athletic Training, Springfield College, Springfield, Massachusetts, USA.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Milch', 'Affiliation': 'Department of Exercise Science and Athletic Training, Springfield College, Springfield, Massachusetts, USA.'}, {'ForeName': 'Kelsey Anne', 'Initials': 'KA', 'LastName': 'Moody', 'Affiliation': 'Department of Exercise Science and Athletic Training, Springfield College, Springfield, Massachusetts, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Germain', 'Affiliation': 'Department of Nephrology, Bay State Medical Center, Springfield, Massachusetts, USA.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Stewart', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Loren', 'Initials': 'L', 'LastName': 'Lipworth', 'Affiliation': ""Vanderbilt O'Brien Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Himmelfarb', 'Affiliation': 'Kidney Research Institute, Division of Nephrology, Department of Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'T Alp', 'Initials': 'TA', 'LastName': 'Ikizler', 'Affiliation': ""Vanderbilt O'Brien Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.""}, {'ForeName': 'Cassianne', 'Initials': 'C', 'LastName': 'Robinson-Cohen', 'Affiliation': ""Vanderbilt O'Brien Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.""}]",Kidney international reports,['10.1016/j.ekir.2020.06.006']
2105,32775826,Biological Efficacy and Safety of Niacinamide in Patients With ADPKD.,"Introduction


Autosomal dominant polycystic kidney disease (ADPKD) is characterized by progressive cyst enlargement, leading to kidney failure. Sirtuin-1 is upregulated in ADPKD and accelerates disease progression by deacetylating p53. Niacinamide is a dietary supplement that inhibits sirtuins at high doses.
Methods


We conducted an open-label, single-arm intervention trial (study 1,  N  = 10), and a randomized, double blinded, placebo-controlled trial (study 2,  N  = 36) to assess the biological activity and safety of niacinamide. Patients with ADPKD were given 30 mg/kg oral niacinamide or placebo, for 12 months. The primary endpoint was the ratio of acetylated p53 to total p53 protein in peripheral blood mononuclear cells (PBMCs).
Results


There was no sustained effect of niacinamide on acetylated/total p53 in either study and no difference between placebo and niacinamide arms. There was no difference in the change in height-adjusted total kidney volume over 12 months between niacinamide and placebo. Niacinamide was generally well tolerated. The most common adverse effects were nausea, diarrhea, gastroesophageal reflux, headache, and acneiform rash but there was no difference in their incidence between niacinamide and placebo.
Conclusions


In conclusion, niacinamide is safe and well-tolerated in patients with ADPKD. However, we were unable to detect a sustained inhibition of sirtuin activity over 12 months of treatment, and there was no signal to suggest a beneficial effect on any efficacy measure.",2020,There was no difference in the change in height-adjusted total kidney volume over 12 months between niacinamide and placebo.,"['patients with ADPKD', 'Patients With ADPKD']","['placebo', 'oral niacinamide or placebo', 'niacinamide', 'Niacinamide']","['nausea, diarrhea, gastroesophageal reflux, headache, and acneiform rash', 'tolerated', 'ratio of acetylated p53 to total p53 protein in peripheral blood mononuclear cells (PBMCs', 'sirtuin activity', 'biological activity and safety of niacinamide', 'safe and well-tolerated', 'height-adjusted total kidney volume', 'Biological Efficacy and Safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085413', 'cui_str': 'Autosomal dominant polycystic kidney disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028027', 'cui_str': 'Niacinamide'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0079419', 'cui_str': 'Genes, TP53'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0080055', 'cui_str': 'Oncoprotein p53'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C1136177', 'cui_str': 'Silent Mating Type Information Regulator 2-like Proteins'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.267256,There was no difference in the change in height-adjusted total kidney volume over 12 months between niacinamide and placebo.,"[{'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'El Ters', 'Affiliation': 'Division of Nephrology and Hypertension, University of Kansas Medical Center, Kansas City, Kansas, USA.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Division of Nephrology and Hypertension, University of Kansas Medical Center, Kansas City, Kansas, USA.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Lepping', 'Affiliation': 'Hoglund Biomedical Imaging Center, University of Kansas Medical Center, Kansas City, Kansas, USA.'}, {'ForeName': 'Pengcheng', 'Initials': 'P', 'LastName': 'Lu', 'Affiliation': 'Department of Biostatistics and Data Science, University of Kansas Medical Center, Kansas City, Kansas, USA.'}, {'ForeName': 'Rainer T', 'Initials': 'RT', 'LastName': 'Karcher', 'Affiliation': 'Hoglund Biomedical Imaging Center, University of Kansas Medical Center, Kansas City, Kansas, USA.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Mahnken', 'Affiliation': 'Department of Biostatistics and Data Science, University of Kansas Medical Center, Kansas City, Kansas, USA.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Brooks', 'Affiliation': 'Hoglund Biomedical Imaging Center, University of Kansas Medical Center, Kansas City, Kansas, USA.'}, {'ForeName': 'Franz T', 'Initials': 'FT', 'LastName': 'Winklhofer', 'Affiliation': 'Division of Nephrology and Hypertension, University of Kansas Medical Center, Kansas City, Kansas, USA.'}, {'ForeName': 'Xiaogang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Division of Nephrology and Hypertension, University of Kansas Medical Center, Kansas City, Kansas, USA.'}, {'ForeName': 'Alan S L', 'Initials': 'ASL', 'LastName': 'Yu', 'Affiliation': 'Division of Nephrology and Hypertension, University of Kansas Medical Center, Kansas City, Kansas, USA.'}]",Kidney international reports,['10.1016/j.ekir.2020.06.002']
2106,32775828,Associations Between Changes in Plasma Renin Activity and Aldosterone Concentrations and Changes in Kidney Function After Treatment for Primary Aldosteronism.,"Introduction


Greater reduction in estimated glomerular filtration rate (eGFR) after specific treatment for primary aldosteronism (PA) reflects improvement in glomerular hyperfiltration associated with PA and leads to better patient outcomes. However, little is known regarding the mechanisms underlying eGFR reduction after treatment for PA.
Methods


We analyzed data from the nationwide PA registry in Japan. Patients were assigned to adrenalectomy (n = 438) and mineralocorticoid receptor (MR) antagonist (n = 746) groups. We assessed associations between changes in blood pressure (BP), plasma renin activity (PRA) and plasma aldosterone concentrations (PAC), and eGFR before and 6 months after treatment for both groups.
Results


In a multivariable linear regression, the adjusted β values (95% confidence interval [CI]) for change in eGFR after treatment were -2.76 (-4.29, -1.22) ml/min per 1.73 m 2  for PRA (per 3.2 ng/ml per hour), and 1.97 (1.08, 2.85) ml/min per 1.73 m 2  for PAC (per 236.1 pg/ml) in the adrenalectomy group; and -0.45 (-0.89, -0.01) ml/min per 1.73 m 2  for PRA and -0.72 (-1.62, 0.18) ml/min per 1.73 m 2  for PAC in the MR antagonist group. Change in mean arterial pressure after treatment was not significantly associated with change in eGFR in either group. Changes in PRA and PAC but not BP before and 6 months after treatment for PA were associated with greater reductions in eGFR.
Conclusion


Post-treatment improvements in glomerular hyperfiltration may be attributable to decreased MR activity in the kidneys, but not to reductions in systemic BP.",2020,"Changes in PRA and PAC but not BP before and 6 months after treatment for PA were associated with greater reductions in eGFR.
",['nationwide PA registry in Japan'],"['adrenalectomy', 'mineralocorticoid receptor (MR) antagonist']","['systemic BP', 'estimated glomerular filtration rate (eGFR', 'mean arterial pressure', 'MR activity', 'Plasma Renin Activity and Aldosterone Concentrations and Changes in Kidney Function', 'blood pressure (BP), plasma renin activity (PRA) and plasma aldosterone concentrations (PAC), and eGFR']","[{'cui': 'C1384514', 'cui_str': 'Primary aldosteronism'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0001632', 'cui_str': 'Adrenalectomy'}, {'cui': 'C0066563', 'cui_str': 'Mineralocorticoid Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0066563', 'cui_str': 'Mineralocorticoid Receptor'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0857639', 'cui_str': 'Plasma aldosterone'}]",,0.145009,"Changes in PRA and PAC but not BP before and 6 months after treatment for PA were associated with greater reductions in eGFR.
","[{'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Kobayashi', 'Affiliation': 'Center for Novel and Exploratory Clinical Trials (Y-NEXT), Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Haze', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Yano', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Kouichi', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Kurihara', 'Affiliation': 'Department of Endocrinology, Metabolism and Nephrology, School of Medicine, Keio University, Tokyo, Japan.'}, {'ForeName': 'Takamasa', 'Initials': 'T', 'LastName': 'Ichijo', 'Affiliation': 'Department of Diabetes and Endocrinology, Saiseikai Yokohamashi Tobu Hospital, Yokohama, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yoneda', 'Affiliation': 'Department of Health Promotion and Medicine of the Future, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Takuyuki', 'Initials': 'T', 'LastName': 'Katabami', 'Affiliation': 'Division of Metabolism and Endocrinology, Department of Internal Medicine, St. Marianna University School of Medicine, Yokohama City Seibu Hospital, Yokohama, Japan.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Tsuiki', 'Affiliation': 'Department of Endocrinology and Metabolism, National Hospital Organization, Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Wada', 'Affiliation': 'Department of Diabetes and Endocrinology, Sapporo City General Hospital, Sapporo, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Ogawa', 'Affiliation': 'Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Kawashima', 'Affiliation': 'Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Masakatsu', 'Initials': 'M', 'LastName': 'Sone', 'Affiliation': 'Department of Diabetes, Endocrinology and Nutrition, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Nobuya', 'Initials': 'N', 'LastName': 'Inagaki', 'Affiliation': 'Department of Diabetes, Endocrinology and Nutrition, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Molecular Endocrinology and Metabolism, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Okamoto', 'Affiliation': 'Department of Cardiology, Mie University Hospital, Mie, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Fujita', 'Affiliation': 'Department of Nephrology and Endocrinology, Faculty of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Kamemura', 'Affiliation': 'Department of Cardiology, Akashi Medical Center, Akashi, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Geriatric and General Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Shoichiro', 'Initials': 'S', 'LastName': 'Izawa', 'Affiliation': 'Division of Cardiovascular Medicine, Endocrinology and Metabolism, Tottori University Faculty of Medicine, Yonago, Japan.'}, {'ForeName': 'Akiyo', 'Initials': 'A', 'LastName': 'Tanabe', 'Affiliation': 'Department of Diabetes, Endocrinology and Metabolism, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Mitsuhide', 'Initials': 'M', 'LastName': 'Naruse', 'Affiliation': 'Clinical Research Institute of Endocrinology and Metabolism, Kyoto Medical Center, National Hospital Organization, Kyoto, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Kidney international reports,['10.1016/j.ekir.2020.06.012']
2107,32775836,A Randomized Trial of Liposomal Prednisolone (LIPMAT) to Enhance Radiocephalic Fistula Maturation: A Pilot Study.,,2020,,[],['Liposomal Prednisolone (LIPMAT'],[],[],"[{'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]",[],,0.0589535,,"[{'ForeName': 'Bram M', 'Initials': 'BM', 'LastName': 'Voorzaat', 'Affiliation': 'Department of Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'K E A', 'Initials': 'KEA', 'LastName': 'van der Bogt', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Taisiya', 'Initials': 'T', 'LastName': 'Bezhaeva', 'Affiliation': 'Department of Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'van Schaik', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Eefting', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Karien', 'Initials': 'K', 'LastName': 'van der Putten', 'Affiliation': 'Department of Nephrology, Tergooi Hospital, Hilversum, The Netherlands.'}, {'ForeName': 'Roos C', 'Initials': 'RC', 'LastName': 'van Nieuwenhuizen', 'Affiliation': 'Department of Vascular Surgery, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Johannes O', 'Initials': 'JO', 'LastName': 'Groeneveld', 'Affiliation': 'Department of Nephrology, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Ellen K', 'Initials': 'EK', 'LastName': 'Hoogeveen', 'Affiliation': 'Department of Nephrology, Jeroen Bosch Ziekenhuis, Hertogenbosch, The Netherlands.'}, {'ForeName': 'Irene M', 'Initials': 'IM', 'LastName': 'van der Meer', 'Affiliation': 'Department of Nephrology, Haga Hospital, The Hague, The Netherlands.'}, {'ForeName': 'Randolph G', 'Initials': 'RG', 'LastName': 'Statius van Eps', 'Affiliation': 'Department of Vascular Surgery, Haga Hospital, The Hague, The Netherlands.'}, {'ForeName': 'Liffert', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Department of Nephrology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Laurens', 'Initials': 'L', 'LastName': 'Huisman', 'Affiliation': 'Department of Vascular Surgery, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Bas A Th F', 'Initials': 'BATF', 'LastName': 'Gabreëls', 'Affiliation': 'Department of Nephrology, Alrijne Hospital, Leiderdorp, The Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Boom', 'Affiliation': 'Department of Nephrology, Reinier de Graaf Hospital, Delft, The Netherlands.'}, {'ForeName': 'Cornelis A', 'Initials': 'CA', 'LastName': 'Verburgh', 'Affiliation': 'Department of Nephrology, Spaarne Hospital, Haarlem, The Netherlands.'}, {'ForeName': 'Diederik', 'Initials': 'D', 'LastName': 'Boon', 'Affiliation': 'Department of Nephrology, Dijklander Hospital, Hoorn, The Netherlands.'}, {'ForeName': 'Josbert M', 'Initials': 'JM', 'LastName': 'Metselaar', 'Affiliation': 'Management Team, Enceladus Pharmaceuticals, Naarden, The Netherlands.'}, {'ForeName': 'Marcel C', 'Initials': 'MC', 'LastName': 'Weijmer', 'Affiliation': 'Department of Nephrology, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Joris I', 'Initials': 'JI', 'LastName': 'Rotmans', 'Affiliation': 'Department of Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands.'}]",Kidney international reports,['10.1016/j.ekir.2020.05.030']
2108,32775959,The Impact of a Sustained Cognitive Engagement Intervention on Cognitive Variability: The Synapse Project.,"Background


Interest in maintaining one's cognitive ability and quality of life through older adulthood has greatly increased in recent years. However, research examining the effectiveness of cognitive engagement interventions on older adults is mixed and the mechanisms behind improving cognition in older age are unknown. It is possible that traditional measures of cognitive outcomes, such as average reaction time, may overlook potential benefits due to a lack of sensitivity in these measures. One alternative metric is intraindividual variability (IIV) in response speed (short-term variations in performance on reaction time tasks), which reflects fluctuations in attention and is a sensitive behavioral measure of neurological integrity that is predictive of future cognitive decline and impairment.
Objective


The current study aimed to investigate whether IIV was improved in older adults through productive cognitive engagement (i.e., acquisition of new skills) in comparison to receptive engagement (activities that rely upon existing knowledge).
Methods


Participants were 173 typically aging adults aged 60-90 years who were recruited to the Synapse Project and randomly allocated to a productive engagement activity (learning to quilt and/or conduct digital photography) or receptive engagement activity (socializing, or placebo cognitive tasks such as completing crosswords). Participants completed three flanker tasks at baseline and after completing the 14-week intervention program. IIV was calculated as the trial-to-trial variability in responding to congruent and incongruent trials in each task.
Results


Neither traditional intent-to-treat nor complier average causal effect modeling analyses showed any significant improvements in IIV for either intervention group. Further, Bayesian analyses showed that there was moderate evidence in favor of the null hypothesis.
Conclusion


An intensive cognitive activity intervention did not result in a reduction in IIV. We suggest that intervention programs may need to specifically engage cognitive domains associated with IIV (i.e., attention, executive control) for improvements to be observed. Additionally, other design factors such as using a longer duration and/or applying the intervention to atypically aging groups, such as those with mild cognitive impairment, may increase the likelihood of significantly reducing IIV via an intervention.",2019,Neither traditional intent-to-treat nor complier average causal effect modeling analyses showed any significant improvements in IIV for either intervention group.,"['older adults', 'Methods\n\n\nParticipants were 173 typically aging adults aged 60-90 years who were recruited to the Synapse Project']","['Sustained Cognitive Engagement Intervention', 'intensive cognitive activity intervention', 'productive engagement activity (learning to quilt and/or conduct digital photography) or receptive engagement activity (socializing, or placebo cognitive tasks such as completing crosswords', 'cognitive engagement interventions']",['Cognitive Variability'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039062', 'cui_str': 'Synapse structure'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C4044304', 'cui_str': 'Quilt'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",[],173.0,0.0423925,Neither traditional intent-to-treat nor complier average causal effect modeling analyses showed any significant improvements in IIV for either intervention group.,"[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Brydges', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, USA.'}, {'ForeName': 'Allison A M', 'Initials': 'AAM', 'LastName': 'Bielak', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, USA.'}]",Journal of cognitive enhancement : towards the integration of theory and practice,['10.1007/s41465-019-00140-9']
2109,32776103,Catecholaminergic Modulation of Semantic Processing in Sentence Comprehension.,"Catecholamine (CA) function has been widely implicated in cognitive functions that are tied to the prefrontal cortex and striatal areas. The present study investigated the effects of methylphenidate, which is a CA agonist, on the electroencephalogram (EEG) response related to semantic processing using a double-blind, placebo-controlled, randomized, crossover, within-subject design. Forty-eight healthy participants read semantically congruent or incongruent sentences after receiving 20-mg methylphenidate or a placebo while their brain activity was monitored with EEG. To probe whether the catecholaminergic modulation is task-dependent, in one condition participants had to focus on comprehending the sentences, while in the other condition, they only had to attend to the font size of the sentence. The results demonstrate that methylphenidate has a task-dependent effect on semantic processing. Compared to placebo, when semantic processing was task-irrelevant, methylphenidate enhanced the detection of semantic incongruence as indexed by a larger N400 amplitude in the incongruent sentences; when semantic processing was task-relevant, methylphenidate induced a larger N400 amplitude in the semantically congruent condition, which was followed by a larger late positive complex effect. These results suggest that CA-related neurotransmitters influence language processing, possibly through the projections between the prefrontal cortex and the striatum, which contain many CA receptors.",2020,"Compared to placebo, when semantic processing was task-irrelevant, methylphenidate enhanced the detection of semantic incongruence as indexed by a larger N400 amplitude in the incongruent sentences; when semantic processing was task-relevant, methylphenidate induced a larger N400 amplitude in the semantically congruent condition, which was followed by a larger late positive complex effect.","['Forty-eight healthy participants', 'Sentence Comprehension']","['methylphenidate', 'Catecholamine (CA) function', 'placebo']","['read semantically congruent or incongruent sentences', 'semantic processing']","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0439853', 'cui_str': 'Congruent'}, {'cui': 'C1321310', 'cui_str': 'Incongruous'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}]",48.0,0.0768094,"Compared to placebo, when semantic processing was task-irrelevant, methylphenidate enhanced the detection of semantic incongruence as indexed by a larger N400 amplitude in the incongruent sentences; when semantic processing was task-relevant, methylphenidate induced a larger N400 amplitude in the semantically congruent condition, which was followed by a larger late positive complex effect.","[{'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Max Planck Institute for Psycholinguistics, Nijmegen 6525 XD, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hagoort', 'Affiliation': 'Max Planck Institute for Psycholinguistics, Nijmegen 6525 XD, The Netherlands.'}]","Cerebral cortex (New York, N.Y. : 1991)",['10.1093/cercor/bhaa204']
2110,32776169,Caregiver burden in stroke inpatients: a randomized study comparing robot-assisted gait training and conventional therapy.,"The effects of caregiver burden during the inpatient rehabilitation period have not yet been investigated. The purpose of this study was to evaluate the burden on stroke survivors' caregivers during the inpatient rehabilitation period, and to compare the associations of robot-assisted gait training and conventional therapy with caregiver burden. Our randomized, crossover, prospective study included 63 stroke survivors and their caregivers, who were randomly assigned to one of two groups. The patients in group I received robot-assisted gait training for 2 weeks, followed by conventional therapy for a further 2 weeks. The patients in group II received conventional therapy for 2 weeks followed by robot-assisted gait training for a further 2 weeks. The caregiver burden inventory, beck depression index, and beck hopelessness scale were administered to the caregivers at day 0, on the ""switch day"" (day 15), and day 30. Before inpatient rehabilitation, 18 (35%) of the caregivers had somewhat elevated scores on the caregiver burden inventory; however, at the end of rehabilitation, 42 (66.6%) of the caregivers were in a high-burden state. The caregiver burden inventory scores differed significantly between baseline and the end of rehabilitation in both groups. Caregiver depression scores also increased significantly in both groups (p < 0.0001), while hopelessness scores increased only in group II (p = 0.027). Caregiver burden increased during the inpatient stroke rehabilitation period. During inpatient rehabilitation, both robot-assisted gait training and conventional therapy increased caregiver burden.ClinicalTrials.gov Number NCT03535467, First Posted: 24 May 2018.",2020,"Caregiver depression scores also increased significantly in both groups (p < 0.0001), while hopelessness scores increased only in group II (p = 0.027).","['stroke inpatients', '63 stroke survivors and their caregivers']","['robot-assisted gait training and conventional therapy', 'conventional therapy for 2\xa0weeks followed by robot-assisted gait training', 'robot-assisted gait training', 'robot-assisted gait training and conventional therapy with caregiver burden']","['hopelessness scores', 'caregiver burden', 'Caregiver burden', 'Caregiver depression scores', 'caregiver burden inventory, beck depression index, and beck hopelessness scale', 'caregiver burden inventory scores']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0150041', 'cui_str': 'Feeling hopeless'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0582612', 'cui_str': 'Beck hopelessness scale'}]",,0.0783276,"Caregiver depression scores also increased significantly in both groups (p < 0.0001), while hopelessness scores increased only in group II (p = 0.027).","[{'ForeName': 'Mehmet Akif', 'Initials': 'MA', 'LastName': 'Guler', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Gaziosmanpasa Training and Research Hospital, Health Sciences University, Mevlana, 884. Street No. 23, Gaziosmanpasa, 34255, Istanbul, Turkey. makifguler89@gmail.com.'}, {'ForeName': 'Belgin', 'Initials': 'B', 'LastName': 'Erhan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Medeniyet University, School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Yilmaz Yalcinkaya', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Gaziosmanpasa Training and Research Hospital, Health Sciences University, Mevlana, 884. Street No. 23, Gaziosmanpasa, 34255, Istanbul, Turkey.'}]",Acta neurologica Belgica,['10.1007/s13760-020-01465-5']
2111,32776173,Visual motion perception improvements following direct current stimulation over V5 are dependent on initial performance.,"Transcranial direct current stimulation (tDCS) can improve visual perception. However, the effect of tDCS on visual perception is largely variable, possibly due to individual differences in initial performance. The goal of the present study was to evaluate the dependency of visual motion perception improvements on initial performance. Twenty-eight observers were randomly divided into two groups. Anodal tDCS and sham stimulation were separately applied to V5 (1.5 mA, 20 min), while observers performed a coherent motion direction identification task. The results showed that compared to sham stimulation, anodal tDCS induced a significant improvement in motion perception that lasted at least 20 min. In addition, the degree of improvement was dependent on initial performance, with a greater improvement magnitude observed for those with poorer initial performance. These results may have implications for understanding the nature of the stimulation rule and for the use of a customised stimulation protocol to enhance tDCS efficiency in practical applications.",2020,"The results showed that compared to sham stimulation, anodal tDCS induced a significant improvement in motion perception that lasted at least 20 min.",['Twenty-eight observers'],"['Anodal tDCS and sham stimulation', 'Transcranial direct current stimulation (tDCS', 'tDCS']","['motion perception', 'visual perception']","[{'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0026598', 'cui_str': 'Perception of movement'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]",28.0,0.0186309,"The results showed that compared to sham stimulation, anodal tDCS induced a significant improvement in motion perception that lasted at least 20 min.","[{'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ""Department of Medical Psychology, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Chenxi', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Scholl of Nursing, Yueyang Vocational Technical College, Yueyang, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': ""Department of Nursing, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Pengbo', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': ""Department of Medical Psychology, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': ""Department of Medical Psychology, Air Force Medical University, Xi'an, China. 42958732@qq.com.""}]",Experimental brain research,['10.1007/s00221-020-05842-7']
2112,32776202,Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADO ® /DYNAGITO ®  Trials.,"INTRODUCTION


Previous studies demonstrated that tiotropium/olodaterol reduced rates of exacerbations in patients with chronic obstructive pulmonary disease (COPD). However, this should be examined in a wider population.
METHODS


This post hoc analysis pooled data from TONADO ®  1 + 2 and DYNAGITO ® , three 52-week, parallel-group, randomised, double-blind, phase III trials investigating patients with moderate-to-very severe COPD, with and without previous exacerbations, who received tiotropium/olodaterol 5/5 µg or tiotropium 5 µg. Subgroup analyses were conducted on patients stratified by exacerbation history, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2-4 disease severity and baseline inhaled corticosteroid (ICS) use.
RESULTS


In 9942 patients, tiotropium/olodaterol was associated with lower rates of moderate/severe exacerbations (0.68 vs. 0.77 per patient-year; rate ratio (RR) vs. tiotropium 0.89, 95% confidence interval (CI) 0.84, 0.95; P = 0.0003) and exacerbations requiring hospitalisation (0.11 vs. 0.13 per patient-year; RR 0.86, 95% CI 0.75, 0.99; P = 0.0380) versus tiotropium. Lower rates of moderate/severe exacerbations with tiotropium/olodaterol versus tiotropium were evident in patients with 0-1 moderate exacerbation in the previous year (0.54 vs. 0.60 per patient-year; RR 0.90, 95% CI 0.82, 0.98; P = 0.0187) and at least two moderate or at least one severe exacerbation(s) in the previous year (0.97 vs. 1.09 per patient-year; RR 0.89, 95% CI 0.82, 0.97; P = 0.0096). In patients with GOLD 2 and GOLD 3 COPD, moderate/severe exacerbation rates were lower with tiotropium/olodaterol versus tiotropium; GOLD 4 patients showed negligible difference between treatments. When evaluating patients by baseline ICS use, there was a significantly lower rate of moderate/severe exacerbations with tiotropium/olodaterol versus tiotropium in patients receiving ICS.
CONCLUSIONS


Tiotropium/olodaterol decreased the rate of moderate/severe exacerbations and exacerbations leading to hospitalisation versus tiotropium. Results from this large, pooled, post hoc analysis support the use of dual bronchodilation with tiotropium/olodaterol in a broad range of patients, reflective of patients with COPD in clinical practice.
TRIAL REGISTRATION


TONADO ®  1 (ClinicalTrials.gov: NCT01431274); TONADO ®  2 (ClinicalTrials.gov: NCT01431287); DYNAGITO ®  (ClinicalTrials.gov: NCT02296138). People with chronic obstructive pulmonary disease (COPD) may have times when their symptoms worsen, known as exacerbations. This may mean that they need to take additional medications, such as antibiotics or oral steroids. Studies have shown that a combination of two types of inhaled medicine-tiotropium and olodaterol-can help to reduce exacerbations in some people. To see if this is also the case across a larger and more diverse range of people, we combined the results from three studies (TONADO ®  1 + 2 and DYNAGITO ® ) that looked at people who were taking tiotropium and olodaterol together and people who were taking tiotropium alone. We showed that, across a wide range of people, treatment with tiotropium/olodaterol was generally better at reducing exacerbations than tiotropium. Tiotropium/olodaterol also decreased the number of exacerbations that led to hospitalisation compared with tiotropium. Overall, our results support the use of combined tiotropium/olodaterol in people at different stages of COPD.",2020,"In 9942 patients, tiotropium/olodaterol was associated with lower rates of moderate/severe exacerbations (0.68 vs. 0.77 per patient-year; rate ratio (RR) vs. tiotropium 0.89, 95% confidence interval (CI) 0.84, 0.95; P = 0.0003) and exacerbations requiring hospitalisation (0.11 vs. 0.13 per patient-year; RR 0.86, 95% CI 0.75, 0.99; P = 0.0380) versus tiotropium.","['patients with moderate-to-very severe COPD, with and without previous exacerbations, who received', 'patients stratified by exacerbation history, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2-4 disease severity and baseline inhaled corticosteroid (ICS) use', 'patients with chronic obstructive pulmonary disease (COPD', 'Patients with COPD', 'People with chronic obstructive pulmonary disease (COPD']","['tiotropium/olodaterol versus tiotropium; GOLD', 'tiotropium/olodaterol 5/5\xa0µg or tiotropium 5\xa0µg', 'Tiotropium/Olodaterol', 'tiotropium/olodaterol', 'Tiotropium/olodaterol', 'inhaled medicine-tiotropium', 'tiotropium/olodaterol versus tiotropium', 'Tiotropium', 'tiotropium']","['number of exacerbations', 'severe exacerbation rates', 'rate of moderate/severe exacerbations', 'Lower rates of moderate/severe exacerbations', 'Exacerbation Rates', 'exacerbations requiring hospitalisation', 'rates of moderate/severe exacerbations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",9942.0,0.709479,"In 9942 patients, tiotropium/olodaterol was associated with lower rates of moderate/severe exacerbations (0.68 vs. 0.77 per patient-year; rate ratio (RR) vs. tiotropium 0.89, 95% confidence interval (CI) 0.84, 0.95; P = 0.0003) and exacerbations requiring hospitalisation (0.11 vs. 0.13 per patient-year; RR 0.86, 95% CI 0.75, 0.99; P = 0.0380) versus tiotropium.","[{'ForeName': 'Jadwiga A', 'Initials': 'JA', 'LastName': 'Wedzicha', 'Affiliation': 'Respiratory Division, National Heart and Lung Institute, Imperial College London, London, UK. j.wedzicha@imperial.ac.uk.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Buhl', 'Affiliation': 'Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Claus F', 'Initials': 'CF', 'LastName': 'Vogelmeier', 'Affiliation': 'Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps University of Marburg, Member of the German Center for Lung Research (DZL), Marburg, Germany.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'de la Hoz', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Wenqiong', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Anzueto', 'Affiliation': 'Department of Pulmonary Medicine and Critical Care, University of Texas Health Sciences Center and South Texas Veterans Health Care System, San Antonio, TX, USA.'}, {'ForeName': 'Peter M A', 'Initials': 'PMA', 'LastName': 'Calverley', 'Affiliation': 'Clinical Science Centre, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}]",Advances in therapy,['10.1007/s12325-020-01438-3']
2113,32776220,Multiple short bouts of exercise are better than a single continuous bout for cardiometabolic health: a randomised crossover trial.,"PURPOSE


To compare cardiometabolic responses to five consecutive days of daily postprandial exercise accumulated in three 10-min bouts or a single 30-min bout to a no-exercise control.
METHODS


Ten insufficiently active adults completed three trials in a randomised order. Each trial comprised five consecutive days of 30 min of exercise either accumulated in three separate 10-min bouts (ACC) after main meals; a single 30-min bout after dinner (CONT); or a no-exercise control (NOEX). Glucose regulation was assessed from an oral glucose tolerance test. Applanation tonometry was used to assess pulse wave velocity approximately 12 h following completion of the final trial.
RESULTS


Area under the 2-h glucose curve was similar for CONT (mean; 95% CI 917 mmol L -1  2 h -1 ; 815 to 1019) and ACC (931 mmol L -1  2 h -1 ; 794 to 1068, p = 0.671). Area under the 2-h insulin curve was greater following NOEX (70,328 pmol L -1  2 h -1 ; 30,962 to 109,693) than ACC (51,313 pmol L -1  2 h -1 : 21,822 to 80,806, p = 0.007). Pulse wave velocity was lower for ACC (5.96 m s -1 : 5.38 to 6.53) compared to CONT (6.93 m s -1 : 5.92 to 7.94, p = 0.031) but not significantly lower for ACC compared to NOEX (6.52 m s -1 : 5.70 to 7.34, p = 0.151).
CONCLUSION


Accumulating 30 min of moderate-intensity walking in three bouts throughout the day is more effective at reducing markers of cardiometabolic health risk in insufficiently active, apparently healthy adults than a single daily bout. Both accumulated and single-bout walking were equally as effective at reducing postprandial glucose concentrations compared to a no-exercise control. Therefore, accumulating exercise in short bouts after each main meal might be more advantageous for overall cardiometabolic health.",2020,Both accumulated and single-bout walking were equally as effective at reducing postprandial glucose concentrations compared to a no-exercise control.,['Ten insufficiently active adults'],"['CONT ', 'NOEX', 'NOEX ', 'Applanation tonometry', 'single 30-min bout after dinner (CONT); or a no-exercise control (NOEX', 'ACC', 'L']","['postprandial glucose concentrations', 'Glucose regulation', 'cardiometabolic responses', 'Pulse wave velocity', 'Area under the 2-h glucose curve', 'cardiometabolic health risk']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0430862', 'cui_str': 'Applanation tonometry'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C1879671', 'cui_str': 'After dinner'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",10.0,0.121961,Both accumulated and single-bout walking were equally as effective at reducing postprandial glucose concentrations compared to a no-exercise control.,"[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Shambrook', 'Affiliation': 'Holsworth Research Initiative, La Trobe Rural Health School, La Trobe University, P.O. Box 199, Bendigo, VIC, 3552, Australia.'}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': 'Kingsley', 'Affiliation': 'Holsworth Research Initiative, La Trobe Rural Health School, La Trobe University, P.O. Box 199, Bendigo, VIC, 3552, Australia.'}, {'ForeName': 'Nicholas F', 'Initials': 'NF', 'LastName': 'Taylor', 'Affiliation': 'School of Allied Health, Human Services and Sport, La Trobe University, Bundoora, Australia.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Wundersitz', 'Affiliation': 'Holsworth Research Initiative, La Trobe Rural Health School, La Trobe University, P.O. Box 199, Bendigo, VIC, 3552, Australia.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Wundersitz', 'Affiliation': 'Angliss Hospital Community Rehabilitation Programme, Eastern Health, Melbourne, Australia.'}, {'ForeName': 'Brett A', 'Initials': 'BA', 'LastName': 'Gordon', 'Affiliation': 'Holsworth Research Initiative, La Trobe Rural Health School, La Trobe University, P.O. Box 199, Bendigo, VIC, 3552, Australia. b.gordon@latrobe.edu.au.'}]",European journal of applied physiology,['10.1007/s00421-020-04461-y']
2114,32776391,MRI-Based Deep-Learning Model for Distant Metastasis-Free Survival in Locoregionally Advanced Nasopharyngeal Carcinoma.,"BACKGROUND


Distant metastasis is the primary cause of treatment failure in locoregionally advanced nasopharyngeal carcinoma (LANPC).
PURPOSE


To develop a model to evaluate distant metastasis-free survival (DMFS) in LANPC and to explore the value of additional chemotherapy to concurrent chemoradiotherapy (CCRT) for different risk groups.
STUDY TYPE


Retrospective.
POPULATION


In all, 233 patients with biopsy-confirmed nasopharyngeal carcinoma (NPC) from two hospitals.
FIELD STRENGTH


1.5T and 3T.
SEQUENCE


Axial T 2  -weighted (T 2  -w) and contrast-enhanced T 1  -weighted (CET 1  -w) images.
ASSESSMENT


Deep learning was used to build a model based on MRI images (including axial T 2  -w and CET 1  -w images) and clinical variables. Hospital 1 patients were randomly divided into training (n = 169) and validation (n = 19) cohorts; Hospital 2 patients were assigned to a testing cohort (n = 45). LANPC patients were divided into low- and high-risk groups according to their DMFS (P < 0.05). Kaplan-Meier survival analysis was performed to compare the DMFS of different risk groups and subgroup analysis was performed to compare patients treated with CCRT alone and treated with additional chemotherapy to CCRT in different risk groups, respectively.
STATISTICAL TESTS


Univariate analysis was performed to identify significant clinical variables. The area under the receiver operating characteristic (ROC) curve (AUC) was used to assess the model performance.
RESULTS


Our deep-learning model integrating the deep-learning signature, node (N) stage (from TNM staging), plasma Epstein-Barr virus (EBV)-DNA, and treatment regimens yielded an AUC of 0.796 (95% confidence interval [CI]: 0.729-0.863), 0.795 (95% CI: 0.540-1.000), and 0.808 (95% CI: 0.654-0.962) in the training, internal validation, and external testing cohorts, respectively. Low-risk patients treated with CCRT alone had longer DMFS than patients treated with additional chemotherapy to CCRT (P < 0.05).
DATA CONCLUSION


The proposed deep-learning model, based on MRI features and clinical variates, facilitated the prediction of DMFS in LANPC patients.
LEVEL OF EVIDENCE


3.
TECHNICAL EFFICACY STAGE


4.",2020,", plasma Epstein-Barr virus (EBV)-DNA, and treatment regimens yielded an AUC of 0.796 (95% confidence interval [CI]: 0.729-0.863), 0.795 (95% CI: 0.540-1.000), and 0.808 (95% CI: 0.654-0.962) in the training, internal validation, and external testing cohorts, respectively.","['233 patients with biopsy-confirmed nasopharyngeal carcinoma (NPC) from two hospitals.\nFIELD STRENGTH\n\n\n1.5T and 3T', 'locoregionally advanced nasopharyngeal carcinoma (LANPC', 'Locoregionally Advanced Nasopharyngeal Carcinoma', 'Hospital 1 patients were randomly divided into training (n = 169) and validation (n = 19) cohorts; Hospital 2 patients']","['concurrent chemoradiotherapy (CCRT', 'CCRT', 'MRI-Based Deep-Learning Model', 'LANPC']","[' plasma Epstein-Barr virus (EBV)-DNA', 'distant metastasis-free survival (DMFS', 'area under the receiver operating characteristic (ROC) curve (AUC', 'longer DMFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1097281', 'cui_str': '3-(3,4-dimethoxyphenyl)-1H-1,2,4-triazole'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0014644', 'cui_str': 'Epstein-Barr Virus'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",233.0,0.0639061,", plasma Epstein-Barr virus (EBV)-DNA, and treatment regimens yielded an AUC of 0.796 (95% confidence interval [CI]: 0.729-0.863), 0.795 (95% CI: 0.540-1.000), and 0.808 (95% CI: 0.654-0.962) in the training, internal validation, and external testing cohorts, respectively.","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Xiangjun', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'School of Artificial Intelligence, University of Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Xiaokai', 'Initials': 'X', 'LastName': 'Mo', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Qiuying', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Minmin', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Zhuozhi', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Shuyi', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Luyan', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'You', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Binghang', 'Initials': 'B', 'LastName': 'Tang', 'Affiliation': 'Department of Radiology, Zhongshan Hospital of Sun Yat-sen University, Zhongshan, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Dong', 'Affiliation': 'School of Artificial Intelligence, University of Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Shuixing', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.27308']
2115,32776425,A study assessing the feasibility of randomization of pediatric and young adult patients between matched unrelated donor bone marrow transplantation and immune-suppressive therapy for newly diagnosed severe aplastic anemia: A joint pilot trial of the North American Pediatric Aplastic Anemia Consortium and the Pediatric Transplantation and Cellular Therapy Consortium.,"BACKGROUND


Recent data show survival after matched unrelated donor (MUD) bone marrow transplantation (BMT) is similar to matched sibling procedures for young patients with severe aplastic anemia (SAA). Donor delays, risk of transplant-related mortality (TRM), and concern about chronic graft versus host disease raise questions about whether MUD BMT or immune suppression therapy (IST) should be preferred initial therapy for young patients lacking matched sibling donors.
PROCEDURE


We performed a pilot trial to assess the feasibility of randomizing patients under age 26 with newly diagnosed SAA to receive IST versus MUD BMT. Primary aims assessed the acceptability of randomization and timing of BMT. Secondary aims measured toxicities, response, and survival.
RESULTS


Sixty-seven patients with possible SAA were screened at nine centers. Of 57 with confirmed SAA, 23 underwent randomization and received therapy with a median follow-up of 18 months. Of 12 randomized to BMT, 10 started BMT as initial therapy at a median of 36 days after randomization. One BMT recipient experienced secondary graft failure, requiring a second procedure. Six of 11 randomized to IST responded, whereas five with refractory disease underwent successful salvage BMT. One patient achieving complete response relapsed after discontinuation of immune suppression and died of infection after salvage BMT.
CONCLUSIONS


This feasibility study showed that a high percentage of patients underwent randomization and received up-front MUD BMT. Our study lays the groundwork for a larger randomized trial that will define best initial therapy for young patients with SAA who have an available MUD.",2020,"One BMT recipient experienced secondary graft failure, requiring a second procedure.","['young patients with severe aplastic anemia (SAA', 'young patients lacking matched sibling donors', 'young patients with SAA who have an available MUD', 'randomizing patients under age 26 with newly diagnosed SAA to receive', 'Sixty-seven patients with possible SAA', 'pediatric and young adult patients between matched unrelated donor', 'newly diagnosed severe aplastic anemia', 'North American Pediatric Aplastic Anemia Consortium and the Pediatric Transplantation and Cellular Therapy Consortium']","['bone marrow transplantation and immune-suppressive therapy', 'IST versus MUD BMT', 'matched unrelated donor (MUD) bone marrow transplantation (BMT', 'BMT', 'IST', 'successful salvage BMT', 'MUD BMT or immune suppression therapy (IST']","['toxicities, response, and survival', 'acceptability of randomization and timing of BMT', 'Donor delays, risk of transplant-related mortality (TRM', 'secondary graft failure']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002874', 'cui_str': 'Aplastic anemia'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C3179133', 'cui_str': 'Donors, Unrelated'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0425358', 'cui_str': 'North American origin'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0302189', 'cui_str': 'Therapy, Cell'}]","[{'cui': 'C0005961', 'cui_str': 'Transplantation of bone marrow'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0205367', 'cui_str': 'Suppressive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C3179133', 'cui_str': 'Donors, Unrelated'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0005961', 'cui_str': 'Transplantation of bone marrow'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1262018', 'cui_str': 'Transplant failure'}]",67.0,0.0843516,"One BMT recipient experienced secondary graft failure, requiring a second procedure.","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Pulsipher', 'Affiliation': ""Cancer and Blood Disease Institute, Children's Hospital Los Angeles, University of Southern California Keck School of Medicine, Los Angeles, California.""}, {'ForeName': 'Leslie E', 'Initials': 'LE', 'LastName': 'Lehmann', 'Affiliation': ""Boston Children's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Alison A', 'Initials': 'AA', 'LastName': 'Bertuch', 'Affiliation': ""Baylor College of Medicine, Center for Cell and Gene Therapy and Texas Children's Hospital, Houston, Texas.""}, {'ForeName': 'Ghadir', 'Initials': 'G', 'LastName': 'Sasa', 'Affiliation': ""Baylor College of Medicine, Center for Cell and Gene Therapy and Texas Children's Hospital, Houston, Texas.""}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Olson', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Taizo', 'Initials': 'T', 'LastName': 'Nakano', 'Affiliation': ""Children's Hospital Colorado, Aurora, Colorado.""}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Gilio', 'Affiliation': 'Pediatric Hematology & Oncology, Hackensack, NJ.'}, {'ForeName': 'Lauri M', 'Initials': 'LM', 'LastName': 'Burroughs', 'Affiliation': 'Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Lipton', 'Affiliation': ""Division of Hematology/Oncology and Cellular Therapy, Cohen Children's Medical Center of New York, New York.""}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Huang', 'Affiliation': ""UCSF Benioff Children's Hospital and University of California, San Francisco, California.""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Dickerson', 'Affiliation': 'UT Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Bertaina', 'Affiliation': 'Division of Stem Cell Transplantation and Regenerative Medicine, Department of Pediatrics, Stanford School of Medicine, Stanford, California.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Zhuang', 'Affiliation': ""Cancer and Blood Disease Institute, Children's Hospital Los Angeles, University of Southern California Keck School of Medicine, Los Angeles, California.""}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Malsch', 'Affiliation': ""Boston Children's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Fleming', 'Affiliation': ""Boston Children's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Edie', 'Initials': 'E', 'LastName': 'Weller', 'Affiliation': ""Boston Children's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Shimamura', 'Affiliation': ""Boston Children's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Williams', 'Affiliation': ""Boston Children's Hospital and Harvard Medical School, Boston, Massachusetts.""}]",Pediatric blood & cancer,['10.1002/pbc.28444']
2116,32776431,Sexual risk and HIV testing disconnect in men who have sex with men (MSM) recruited to an online HIV self-testing trial.,"OBJECTIVES


We report the frequency of previous HIV testing at baseline in men who have sex with men (MSM) who enrolled in an HIV self-testing (HIVST) randomized controlled trial [an HIV self-testing public health intervention (SELPHI)].
METHODS


Criteria for enrolment were age ≥ 16 years, being a man (including trans men) who ever had anal intercourse (AI) with a man, not being known to be HIV positive and having consented to national HIV database linkage. Using online survey baseline data (2017-2018), we assessed associations with never having tested for HIV and not testing in the previous 6 months, among men who reported at least two recent condomless AI (CAI) partners.
RESULTS


A total of 10 111 men were randomized; the median age was 33 years [interquartile range (IQR) 26-44 years], 89% were white, 20% were born outside the UK, 0.8% were trans men, 47% were degree educated, and 8% and 4% had ever used and were currently using pre-exposure prophylaxis (PrEP), respectively. In the previous 3 months, 89% reported AI and 72% reported CAI with at least one male partner. Overall, 17%, 33%, 54%, and 72% had tested for HIV in the last 3 months, 6 months, 12 months and 2 years, respectively; 13% had tested more than 2 years ago and 15% had never tested. Among 3972 men reporting at least two recent CAI partners, only 22% had tested in the previous 3 months. Region of residence and education level were independently associated with recent HIV testing. Among current PrEP users, 15% had not tested in the previous 6 months.
CONCLUSIONS


Most men in SELPHI, particularly those reporting at least two CAI partners and current PrEP users, were not testing in line with current UK recommendations. The results of the trial will inform whether online promotion of HIVST addresses ongoing testing barriers.",2020,Region of residence and education level were independently associated with recent HIV testing.,"['Criteria for enrolment were age ≥', '3972 men reporting at least two recent CAI partners, only 22% had tested in the previous 3\xa0months', 'men who reported at least two recent condomless AI (CAI) partners', '16\xa0years, being a man (including trans men) who ever had anal intercourse (AI) with a man, not being known to be HIV positive and having consented to national HIV database linkage', 'A total of 10\xa0111 men were randomized; the median age was 33\xa0years [interquartile range (IQR) 26-44 years], 89% were white, 20% were born outside the UK, 0.8% were trans men, 47% were degree educated, and 8% and 4% had ever used and were currently using pre-exposure prophylaxis (PrEP), respectively', 'men who have sex with men (MSM) who enrolled in an HIV self-testing (HIVST) randomized controlled trial [an', 'men who have sex with men (MSM']",['HIV self-testing public health intervention (SELPHI'],['Sexual risk and HIV testing disconnect'],"[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0619283', 'cui_str': 'IS 33'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}]",10111.0,0.1143,Region of residence and education level were independently associated with recent HIV testing.,"[{'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Rodger', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dunn', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'McCabe', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Weatherburn', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'F C', 'Initials': 'FC', 'LastName': 'Lampe', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'T C', 'Initials': 'TC', 'LastName': 'Witzel', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Burns', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ward', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pebody', 'Affiliation': 'NAM, London, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Trevelion', 'Affiliation': 'HIV i-Base, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Brady', 'Affiliation': ""King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'Kirwan', 'Affiliation': 'National Infection Service, Public Health England, London, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Khawam', 'Affiliation': 'National Infection Service, Public Health England, London, UK.'}, {'ForeName': 'V C', 'Initials': 'VC', 'LastName': 'Delpech', 'Affiliation': 'National Infection Service, Public Health England, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gabriel', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Collaco-Moraes', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Phillips', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'McCormack', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK.'}]",HIV medicine,['10.1111/hiv.12919']
2117,32776464,Response of exercise-onset vasodilator kinetics to L-citrulline supplementation during different phases of the menstrual cycle.,"The purpose of this study was to determine whether L-citrulline (CIT) supplementation during the follicular and luteal phases of the menstrual cycle would present differential effects on vasodilator kinetics in dynamically contracting muscle. Twenty-four women were studied during the follicular (day 15 after onset of menses, n = 13) or the luteal phase (day 25 after onset of menses, n = 11). Supplementation with CIT (6g/day) or placebo occurred 7-days prior to testing in a crossover design across two menstrual cycles. Forearm vascular conductance (FVC) was calculated from blood flow and mean arterial pressure measured continuously during handgrip exercise performed at 10% maximal grip strength. FVC was calculated for each duty cycle (contract:relax, 1:2s) and expressed as a change from baseline (ΔFVC) before being fit with a monoexponential model. Amplitude of the ΔFVC response and the number of duty cycles for ΔFVC to reach 63% of steady-state amplitude (τΔFVC) were derived from the model. Analysis of variance showed no difference in the amplitude of ΔFVC between CIT and placebo (p = .45) or between menstrual cycle phases (p = .11). Additionally, τΔFVC was not different (p = .35) between CIT and placebo in women tested during the follicular (6 ± 3 versus 5 ± 3 duty cycles) or luteal phase (9 ± 1 versus 8 ± 1 duty cycles) although τΔFVC was found to be slower for women tested during the luteal as compared to the follicular phase (8 ± 4 versus 5 ± 3 duty cycles, p = .02). These results indicate that exercise-onset vasodilator kinetics is unaltered with CIT supplementation in young healthy women irrespective of menstrual cycle phase.",2020,Analysis of variance showed no difference in the amplitude of ΔFVC between CIT and placebo (p = .45) or between menstrual cycle phases (p = .11).,"['Twenty-four women were studied during the follicular (day 15 after onset of menses, n\xa0=\xa013) or the luteal phase (day 25 after onset of menses, n\xa0=\xa011', 'young healthy women irrespective of menstrual cycle phase']","['L-citrulline (CIT) supplementation', 'CIT supplementation', 'exercise-onset vasodilator kinetics to L-citrulline supplementation', 'CIT (6g/day) or placebo', 'placebo']","['Amplitude of the ΔFVC response and the number of duty cycles', 'Forearm vascular conductance (FVC', 'blood flow and mean arterial pressure', 'amplitude of ΔFVC', 'vasodilator kinetics', 'FVC']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0024153', 'cui_str': 'Menstrual Cycle, Luteal Phase'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0042402', 'cui_str': 'Vasodilator agent'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0042402', 'cui_str': 'Vasodilator agent'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}]",24.0,0.0523244,Analysis of variance showed no difference in the amplitude of ΔFVC between CIT and placebo (p = .45) or between menstrual cycle phases (p = .11).,"[{'ForeName': 'Joaquin U', 'Initials': 'JU', 'LastName': 'Gonzales', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Fischer', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Maharaj', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Vellers', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Anderson', 'Affiliation': 'Department of Environmental Toxicology, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Adcharee', 'Initials': 'A', 'LastName': 'Karnjanapiboonwong', 'Affiliation': 'Department of Environmental Toxicology, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Seenivasan', 'Initials': 'S', 'LastName': 'Subbiah', 'Affiliation': 'Department of Environmental Toxicology, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Kellawan', 'Affiliation': 'Department of Health and Exercise Science, University of Oklahoma, Norman, OK, USA.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Figueroa', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University, Lubbock, TX, USA.'}]",Physiological reports,['10.14814/phy2.14536']
2118,32776468,Effect of repeated bouts versus a single bout of moderate-intensity exercise on postexercise inhibitory control.,"We previously demonstrated that duration of aerobic exercise plays an important role in improving cognitive inhibitory control (IC). Repeated bouts of aerobic exercise (R-EX), which are performed with a rest interval, is a useful strategy in improving physical health parameters in similar manners to a single bout of aerobic exercise (S-EX). However, whether R-EX would be effective in improving IC remains unknown. This study compared the effect of R-EX versus S-EX of moderate-intensity exercise on postexercise IC. Twenty healthy, young males performed both R-EX and S-EX in a crossover design. R-EX consisted of two 20-min moderate-intensity bouts (60% of peak oxygen consumption) for 20 min ,  which were separated by a 20-min rest interval. S-EX consisted of a once-off 40-min moderate-intensity bout without rest interval. To evaluate IC, the color-word Stroop task was administered before exercise, immediately after exercise, and every 10 min during the 30-min postexercise recovery period. The reverse-Stroop interference score, which is a parameter of IC, significantly decreased immediately after both R-EX and S-EX compared with that before each exercise (both Ps < 0.05). The degree of changes in IC following exercise did not differ between the two protocols. By contrast, the results of the present study showed that R-EX may have more beneficial effects on cardiac and perceptual responses than S-EX. Therefore, the present study determined that R-EX changes postexercise IC similar to S-EX. We suggest that R-EX can be used as safe and effective exercise protocol to improve cognitive function in various populations.",2020,"The reverse-Stroop interference score, which is a parameter of IC, significantly decreased immediately after both R-EX and S-EX compared with that before each exercise (both Ps < 0.05).","['Twenty healthy, young males']","['moderate-intensity exercise', 'R-EX versus S-EX of moderate-intensity exercise', 'aerobic exercise (R-EX', 'aerobic exercise']",['reverse-Stroop interference score'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0524688,"The reverse-Stroop interference score, which is a parameter of IC, significantly decreased immediately after both R-EX and S-EX compared with that before each exercise (both Ps < 0.05).","[{'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sugimoto', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Suga', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Hayato', 'Initials': 'H', 'LastName': 'Tsukamoto', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Keigo', 'Initials': 'K', 'LastName': 'Tomoo', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Kento', 'Initials': 'K', 'LastName': 'Dora', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Hashimoto', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Isaka', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}]",Physiological reports,['10.14814/phy2.14528']
2119,32782077,Comparison of the Effect of Massage and EMLA Cream on Children's Physiological Indices During Venipuncture: A Factorial Clinical Trial.,"PURPOSE


The aim of this study was to identify the effect of massage, EMLA cream, and the combination of these two methods on changes in physiological indices because of pain caused by intravenous line insertion in preschool children.
DESIGN


A four-group randomized nonblinded clinical trial with factorial design.
METHODS


In total, 140 eligible 3- to 6-year-old children entered the study in Tabriz Children's Hospital in 2017 and were randomly allocated to four groups (EMLA cream, massage, combination of the two, and control). Physiological responses were measured before and immediately after interventions in all groups. Data were collected and analyzed using SPSS version 19.
FINDINGS


Comparison of the physiological indices changes caused by pain between groups showed that changes in children's heart rate (HR) and respiratory rate (RR) in the EMLA group and in the combined-method group were statistically significant (P < .05). No significant differences were found in systolic blood pressure and oxygen saturation (SPo 2 ) between the four groups.
CONCLUSIONS


Results indicated that EMLA cream was more effective than massage and a combination of EMLA and massage in reducing an increase in the HR and RR caused by pain in children. Massage alone was not effective in significantly lowering the children's increased physiological indices such as the HR and RR, and it seems the effectiveness of massage is more noticeable in conjunction with EMLA cream.",2020,"Massage alone was not effective in significantly lowering the children's increased physiological indices such as the HR and RR, and it seems the effectiveness of massage is more noticeable in conjunction with EMLA cream.","[""Children's Physiological Indices"", ""140 eligible 3- to 6-year-old children entered the study in Tabriz Children's Hospital in 2017 and"", 'preschool children']","['Massage and EMLA Cream', 'Massage alone', 'EMLA cream, massage, combination of the two, and control', 'EMLA cream', 'massage, EMLA cream']","['Physiological responses', ""children's heart rate (HR) and respiratory rate (RR"", 'systolic blood pressure and oxygen saturation (SPo 2 ']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}]","[{'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0360032', 'cui_str': 'EMLA Cream'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]",2.0,0.061619,"Massage alone was not effective in significantly lowering the children's increased physiological indices such as the HR and RR, and it seems the effectiveness of massage is more noticeable in conjunction with EMLA cream.","[{'ForeName': 'Hanieh', 'Initials': 'H', 'LastName': 'Neshat', 'Affiliation': 'School of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran; Pediatric Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Kafiyeh', 'Initials': 'K', 'LastName': 'Aslani', 'Affiliation': 'Pediatric Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Pediatric Surgery Unit, Pediatric Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Massoud', 'Initials': 'M', 'LastName': 'Jamshidi', 'Affiliation': 'Pediatric Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Pediatric Surgery Unit, Pediatric Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Aslanabadi', 'Affiliation': 'Pediatric Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Pediatric Surgery Unit, Pediatric Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Ghorbani', 'Affiliation': 'School of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran; Pediatric Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: f.ghorbani2006@gmail.com.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2020.04.005']
2120,32782111,Effects of self-acupressure on pregnancy-related constipation: A single-blind randomized controlled study.,"OBJECTIVES


This study aimed to demonstrate that acupressure could be used to relieve the symptoms of constipation during pregnancy.
DESIGN


Single-blind randomized controlled trial SETTING: Private Medipol Nisa Hospital, Istanbul, Turkey INTERVENTION: This trial including 120 women aged ≥20 years was conducted from November 2019 to February 2020. The participating women who were in the 1st, 2nd or 3rd trimester of their pregnancy, had singleton pregnancy and had a complaint of constipation were randomized into the acupressure (n = 75) and control groups (n = 75). The women in the acupressure group applied 15 min of self-acupressure to the TH-6 acupuncture point twice a day for one week. The women in the control group received no intervention treatment.
MAIN OUTCOME MEASURES


Constipation levels of the participants in the two groups were assessed before and after the procedure using the Constipation Severity Instrument RESULTS: In the present study, after the application of self-acupressure, the severity of constipation decreased significantly in the acupressure group compared to the control group (before treatment: 41.36 ± 6.5 vs. 37.56 ± 6.17 respectively, after treatment: 26.08 ± 7.93 vs. 36.88 ± 5.93, respectively, p < 0.01) CONCLUSION: Although it is safe to use medical drugs in constipation associated with pregnancy, can't reduce it to the extent desired. This study's evidence indicates that self-administered acupressure can effectively alleviate the symptoms of constipation in clinical practice.",2020,This study's evidence indicates that self-administered acupressure can effectively alleviate the symptoms of constipation in clinical practice.,"['participating women who were in the 1st, 2nd or 3rd trimester of their pregnancy, had singleton pregnancy and had a complaint of constipation', '120 women aged ≥20 years was conducted from November 2019 to February 2020']","['acupressure group applied 15\xa0min of self-acupressure to the TH-6 acupuncture', 'self-acupressure', 'no intervention treatment', 'acupressure']","['Constipation levels', 'pregnancy-related constipation', 'severity of constipation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",120.0,0.046524,This study's evidence indicates that self-administered acupressure can effectively alleviate the symptoms of constipation in clinical practice.,"[{'ForeName': 'Ayça Şolt', 'Initials': 'AŞ', 'LastName': 'Kirca', 'Affiliation': 'Kırklareli University School of Health, MidwiferyDepartment Kırklareli, Turkey. Electronic address: aycasolt@hotmail.com.'}, {'ForeName': 'Derya', 'Initials': 'D', 'LastName': 'Kanza Gül', 'Affiliation': 'Medipol University School of Medicine Health, Gynecology and Obstetric Department, Istanbul, Turkey. Electronic address: deryakanza@yahoo.com.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2020.07.004']
2121,32782170,Effect of GnRH agonist before IVF on outcomes in infertile endometriosis patients: a randomized controlled trial.,"RESEARCH QUESTION


Does 3-months of gonadotrophin releasing hormone agonist (GnRHa) treatment before IVF improve clinical pregnancy rate in infertile patients with endometriosis?
DESIGN


Single-blind, placebo-controlled clinical trial of 200 infertile women with endometriosis assigned to use GnRHa (study group) or placebo (control group) for 3 months before IVF. Clinical, embryological outcomes and stimulation parameters were analysed. Clinical pregnancy rate was the primary endpoint. In a subgroup of 40 patients, follicular fluid levels of oestradiol, testosterone and androstendione were measured. Gene expression profile of CYP19A1 was analysed in cumulus and mural granulosa cells.
RESULTS


Implantation or clinical pregnancy rate were not significantly different between the two groups. Clinical pregnancy rates were 25.3% and 33.7% in the study and control groups, respectively (P = 0.212). Cumulative live birth rate was not significantly different: 22.0% (95% CI 13.0 to 31.0) in the study group and 33.7% (95% CI 24.0 to 44.0) in the control group (P = 0.077). Ovarian stimulation was significantly longer and total dose of gonadotrophins significantly higher in the study group (both P < 0.001). Serum oestradiol levels on the day of HCG were significantly lower in the study group (P = 0.001). Cancellation rate was significantly higher in the study group (P = 0.042), whereas cleavage embryos were significantly more numerous in the control group (P = 0.023). No significant differences in the expression of CYP19A1 gene in mural or cumulus granulosa cells or steroid levels in follicular fluid between the two groups were observed, but testosterone was significantly lower in the study group (P < 0.001).
CONCLUSION


Three-months of GnRHa treatment before IVF does not improve clinical pregnancy rate in women with endometriosis.",2020,"Cancellation rate was significantly higher in the study group (P = 0.042), whereas cleavage embryos were significantly more numerous in the control group (P = 0.023).","['infertile endometriosis patients', '200 infertile women with endometriosis assigned to use GnRHa (study group) or', 'infertile patients with endometriosis', 'women with endometriosis']","['GnRH agonist before IVF', 'gonadotrophin releasing hormone agonist (GnRHa) treatment before IVF', 'placebo']","['clinical pregnancy rate', 'Clinical pregnancy rate', 'Ovarian stimulation', 'total dose of gonadotrophins', 'cleavage embryos', 'Cancellation rate', 'Cumulative live birth rate', 'Implantation or clinical pregnancy rate', 'Serum oestradiol levels', 'expression of CYP19A1 gene in mural or cumulus granulosa cells or steroid levels in follicular fluid', 'Clinical pregnancy rates', 'follicular fluid levels of oestradiol, testosterone and androstendione', 'Gene expression profile of CYP19A1']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0010813', 'cui_str': 'Cytokinesis'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0059735', 'cui_str': 'Cytochrome p450 CYP1A1 enzyme'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0441995', 'cui_str': 'Mural'}, {'cui': 'C1956101', 'cui_str': 'Granulosa Cells, Cumulus'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016431', 'cui_str': 'Liquor Folliculi'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C1449575', 'cui_str': 'Microarray Analysis'}]",200.0,0.487422,"Cancellation rate was significantly higher in the study group (P = 0.042), whereas cleavage embryos were significantly more numerous in the control group (P = 0.023).","[{'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Rodríguez-Tárrega', 'Affiliation': 'Human Reproduction Unit, University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain. Electronic address: e.rodriguez.tarrega@gmail.com.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Monzo', 'Affiliation': 'Human Reproduction Unit, University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain; Reproductive Medicine Research Group. Instituto de Investigación Sanitaria La Fe. University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain.'}, {'ForeName': 'Ramiro', 'Initials': 'R', 'LastName': 'Quiroga', 'Affiliation': 'Human Reproduction Unit, University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain.'}, {'ForeName': 'Patrocinio', 'Initials': 'P', 'LastName': 'Polo-Sánchez', 'Affiliation': 'Human Reproduction Unit, University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Fernández-Colom', 'Affiliation': 'Human Reproduction Unit, University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Monterde-Estrada', 'Affiliation': 'Human Reproduction Unit, University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain.'}, {'ForeName': 'Edurne', 'Initials': 'E', 'LastName': 'Novella-Maestre', 'Affiliation': 'Genetic Unit, University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain; Reproductive Medicine Research Group. Instituto de Investigación Sanitaria La Fe. University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pellicer', 'Affiliation': 'Reproductive Medicine Research Group. Instituto de Investigación Sanitaria La Fe. University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain; IVI Rome. Largo Ildebrando Pizzeti, Rome 00197, Italy.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.06.020']
2122,32782181,Text-only and picture conversation aids both supported shared decision making for breast cancer surgery: Analysis from a cluster randomized trial.,"OBJECTIVES


To determine if two encounter conversation aids for early-stage breast cancer surgery increased observed and patient-reported shared decision making (SDM) compared with usual care and if observed and patient-reported SDM were associated.
METHODS


Surgeons in a cluster randomized trial at four cancer centers were randomized to use an Option Grid, Picture Option Grid, or usual care. We used bivariate statistics, linear regression, and multilevel models to evaluate the influence of trial arm, patient socioeconomic status and health literacy on observed SDM (via OPTION-5) and patient-reported SDM (via collaboRATE).
RESULTS


From 311 recordings, OPTION-5 scores were 73/100 for Option Grid (n = 40), 56.3/100 for Picture Option Grid (n = 144), and 41.0/100 for usual care (n = 127; p < 0.0001). Top collaboRATE scores were 81.6 % for Option Grid, 80.0 % for Picture Option Grid, and 56.4 % for usual care (p < 0.001). Top collaboRATE scores correlated with an 8.60 point (95 %CI 0.66, 13.7) higher OPTION-5 score (p = 0.008) with no correlation in the multilevel analysis. Patients of lower socioeconomic status had lower OPTION-5 scores before accounting for clustering.
CONCLUSIONS


Both conversation aids led to meaningfully higher observed and patient-reported SDM. Observed and patient-reported SDM were not strongly correlated.
PRACTICE IMPLICATIONS


Healthcare providers could implement these conversation aids in real-world settings.",2020,"Top collaboRATE scores correlated with an 8.60 point (95 %CI 0.66, 13.7) higher OPTION-5 score (p = 0.008) with no correlation in the multilevel analysis.","['Surgeons in a cluster randomized trial at four cancer centers', 'breast cancer surgery']","['Option Grid, Picture Option Grid, or usual care', 'Text-only and picture conversation aids both supported shared decision making']",[],"[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}]",[],,0.13711,"Top collaboRATE scores correlated with an 8.60 point (95 %CI 0.66, 13.7) higher OPTION-5 score (p = 0.008) with no correlation in the multilevel analysis.","[{'ForeName': 'Renata W', 'Initials': 'RW', 'LastName': 'Yen', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA.'}, {'ForeName': 'Marie-Anne', 'Initials': 'MA', 'LastName': 'Durand', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA; Université Toulouse III Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Harris', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Ward', 'Affiliation': 'Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'A James', 'Initials': 'AJ', 'LastName': ""O'Malley"", 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Schubbe', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA.'}, {'ForeName': 'Catherine H', 'Initials': 'CH', 'LastName': 'Saunders', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA; Centers for Health and Aging, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Elwyn', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA. Electronic address: glynelwyn@gmail.com.'}]",Patient education and counseling,['10.1016/j.pec.2020.07.015']
2123,32782219,Ultrasound-Based Radiomic Nomogram for Predicting Lateral Cervical Lymph Node Metastasis in Papillary Thyroid Carcinoma.,"RATIONALE AND OBJECTIVES


Accurate preoperative identification of lateral cervical lymph node metastasis (LNM) is important for decision-making and clinical management of patients with papillary thyroid carcinoma (PTC). The aim of this study was to develop an ultrasound (US)-based radiomic nomogram to preoperatively predict the lateral LNM in PTC patients.
METHODS


In this retrospective study, a total of 886 patients were enrolled and randomly divided into 2 groups. Radiomic features were extracted from the preoperative US images. A radiomic signature was constructed using the least absolute shrinkage and selection operator algorithm in the training set. Multivariate logistic regression was performed to develop the radiomic nomogram, which incorporating the radiomic signature and the selected clinical characteristics. The performance of the nomogram was assessed by its discrimination, calibration, and clinical usefulness in both the training and validation sets.
RESULTS


The radiomic signature was significantly associated with the lateral LNM in both cohorts (p< 0.001). The nomogram that consisted of radiomic signature, US-reported cervical lymph node (CLN) status, and CT-reported CLN status demonstrated good discrimination and calibration in the training and validation sets with an AUC of 0.946 and 0.914, respectively. The decision curve analysis indicated that the radiomic nomogram was worthy of clinical application.
CONCLUSION


The radiomic nomogram proposed here has good performance for noninvasively predicting the lateral LNM and might be used to facilitate clinical decision-making and potentially improve the survival outcome in selected patients.",2020,The radiomic signature was significantly associated with the lateral LNM in both cohorts (p< 0.001).,"['PTC patients', '886 patients were enrolled and randomly divided into 2 groups', 'patients with papillary thyroid carcinoma (PTC']",['Ultrasound-Based Radiomic Nomogram'],['survival outcome'],"[{'cui': 'C0238463', 'cui_str': 'Papillary thyroid carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1450294', 'cui_str': 'Nomogram chart'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",886.0,0.0244893,The radiomic signature was significantly associated with the lateral LNM in both cohorts (p< 0.001).,"[{'ForeName': 'Yuyang', 'Initials': 'Y', 'LastName': 'Tong', 'Affiliation': ""Department of Ultrasound, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, 270 Dong'an Road, Shanghai 200032, China.""}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, Eye & ENT Hospital of Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Yunxia', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Department of Ultrasound, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, 270 Dong'an Road, Shanghai 200032, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': ""Department of Ultrasound, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, 270 Dong'an Road, Shanghai 200032, China.""}, {'ForeName': 'Tongtong', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Electronic Engineering, Fudan University and Key Laboratory of Medical Imaging Computing and Computer Assisted Intervention of Shanghai, Shanghai 200433, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Electronic Engineering, Fudan University and Key Laboratory of Medical Imaging Computing and Computer Assisted Intervention of Shanghai, Shanghai 200433, China.'}, {'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Electronic Engineering, Fudan University and Key Laboratory of Medical Imaging Computing and Computer Assisted Intervention of Shanghai, Shanghai 200433, China.'}, {'ForeName': 'Shichong', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': ""Department of Ultrasound, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, 270 Dong'an Road, Shanghai 200032, China. Electronic address: sczhou@hotmail.com.""}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Electronic Engineering, Fudan University and Key Laboratory of Medical Imaging Computing and Computer Assisted Intervention of Shanghai, Shanghai 200433, China.'}, {'ForeName': 'Cai', 'Initials': 'C', 'LastName': 'Chang', 'Affiliation': ""Department of Ultrasound, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, 270 Dong'an Road, Shanghai 200032, China.""}]",Academic radiology,['10.1016/j.acra.2020.07.017']
2124,32782651,Evaluation of ivabradine in left ventricular dyssynchrony and reverse remodeling in patients with chronic heart failure.,"Objectives


Ivabradine is a pharmacological agent used in patients with heart failure and sinus rhythm. Its only known pharmacological effect is to slow the heart rate. In this study, we investigated the impact of ivabradine on dyssynchrony parameters in heart failure patients.
Methods


In this study, we assigned 55 patients taking medication for heart failure to receive ivabradine in addition (Group I). Twenty healthy volunteers comprised Group II. Echocardiographic measurements (dyssynchrony, left ventricular volumes and left ventricular ejection fraction) were taken at baseline, 1 month, and 3 months.
Results


A total of 32 heart failure patients in Group I completed the study. There was significant improvement in dyssynchrony parameters after ivabradine treatment in Group I. Interventricular dyssynchrony (IVD) decreased from 42.0 ± 24.4 milliseconds at baseline to 33.6 ± 20.7 milliseconds at 1 month ( P  = .001) and to 30.7 ± 19.4 milliseconds at 3 months ( P  < .001). Septal to posterior wall motion delay decreased from 90.3 ± 21.4 milliseconds to 83.9 ± 26.9 milliseconds ( P  = .011) at 1 month and to 81.5 ± 27.3 milliseconds at 3 months ( P  = .001). Septal to lateral Ts delay (Ts-SL) decreased from 42.7 ± 24.5 milliseconds to 35.8 ± 22.6 milliseconds at 1 month ( P  < .001) and to 34.8 ± 22.4 milliseconds at 3 months ( P  = .002). Left ventricular end-systolic volume (LVESV) decreased from 139.4 ± 42.2 mL to 135.3 ± 39.6 mL at 1 month ( P  = .006) and to 123.3 ± 39.5 mL at 3 months ( P  < .001).
Conclusion


The addition of ivabradine to heart failure treatment improves cardiac dyssynchrony parameters in chronic systolic heart failure patients with sinus rhythm.",2020,There was significant improvement in dyssynchrony parameters after ivabradine treatment in Group I. Interventricular dyssynchrony (IVD) decreased from 42.0 ± 24.4 milliseconds at baseline to 33.6 ± 20.7 milliseconds at 1 month ( P  = .001) and to 30.7 ± 19.4 milliseconds at 3 months ( P  < .001).,"['55 patients taking medication for heart failure to receive ivabradine in addition (Group I', 'Twenty healthy volunteers comprised Group II', 'patients with heart failure and sinus rhythm', 'patients with chronic heart failure', '32 heart failure patients in Group I completed the study', 'heart failure patients', 'chronic systolic heart failure patients with sinus rhythm']","['ivabradine', 'Ivabradine']","['Echocardiographic measurements (dyssynchrony, left ventricular volumes and left ventricular ejection fraction', 'Left ventricular end-systolic volume (LVESV', 'Septal to posterior wall motion delay', 'cardiac dyssynchrony parameters', 'dyssynchrony parameters']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1135194', 'cui_str': 'Chronic systolic heart failure'}]","[{'cui': 'C0257190', 'cui_str': 'ivabradine'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0442004', 'cui_str': 'Septal'}, {'cui': 'C0227701', 'cui_str': 'Structure of posterior wall of urinary bladder'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",55.0,0.0215245,There was significant improvement in dyssynchrony parameters after ivabradine treatment in Group I. Interventricular dyssynchrony (IVD) decreased from 42.0 ± 24.4 milliseconds at baseline to 33.6 ± 20.7 milliseconds at 1 month ( P  = .001) and to 30.7 ± 19.4 milliseconds at 3 months ( P  < .001).,"[{'ForeName': 'Korhan', 'Initials': 'K', 'LastName': 'Soylu', 'Affiliation': 'Department of Cardiology Faculty of Medicine Ondokuz Mayis University Samsun Turkey.'}, {'ForeName': 'Idris Bugra', 'Initials': 'IB', 'LastName': 'Cerik', 'Affiliation': 'Department of Cardiology Faculty of Medicine Cumhuriyet University Sivas Turkey.'}, {'ForeName': 'Gokhan', 'Initials': 'G', 'LastName': 'Aksan', 'Affiliation': 'Department of Cardiology Samsun Education and Research Hospital Samsun Turkey.'}, {'ForeName': 'Gokay', 'Initials': 'G', 'LastName': 'Nar', 'Affiliation': 'Department of Cardiology Faculty of Medicine Pamukkale University Denizli Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Meric', 'Affiliation': 'Department of Cardiology Faculty of Medicine Ondokuz Mayis University Samsun Turkey.'}]",Journal of arrhythmia,['10.1002/joa3.12398']
2125,32776237,Type 2 diabetes remission: 2 year within-trial and lifetime-horizon cost-effectiveness of the Diabetes Remission Clinical Trial (DiRECT)/Counterweight-Plus weight management programme.,"AIMS/HYPOTHESIS


Approximately 10% of total healthcare budgets worldwide are spent on treating diabetes and its complications, and budgets are increasing globally because of ageing populations and more expensive second-line medications. The aims of the study were to estimate the within-trial and lifetime cost-effectiveness of the weight management programme, which achieved 46% remissions of type 2 diabetes at year 1 and 36% at year 2 in the Diabetes Remission Clinical Trial (DiRECT).
METHODS


Within-trial analysis assessed costs of the Counterweight-Plus intervention in DiRECT (including training, programme materials, practitioner appointments and low-energy diet), along with glucose-lowering and antihypertensive medications, and all routine healthcare contacts. Lifetime cost per quality-adjusted life-year (QALY) was estimated according to projected durations of remissions, assuming continued relapse rates as seen in year 2 of DiRECT and consequent life expectancy, quality of life and healthcare costs.
RESULTS


Mean total 2 year healthcare costs for the intervention and control groups were £3036 and £2420, respectively: an incremental cost of £616 (95% CI -£45, £1269). Intervention costs (£1411; 95% CI £1308, £1511) were partially offset by lower other healthcare costs (£796; 95% CI £150, £1465), including reduced oral glucose-lowering medications by £231 (95% CI £148, £314). Net remission at 2 years was 32.3% (95% CI 23.5%, 40.3%), and cost per remission achieved was £1907 (lower 95% CI: intervention dominates; upper 95% CI: £4212). Over a lifetime horizon, the intervention was modelled to achieve a mean 0.06 (95% CI 0.04, 0.09) QALY gain for the DiRECT population and mean total lifetime cost savings per participant of £1337 (95% CI £674, £2081), with the intervention becoming cost-saving within 6 years.
CONCLUSIONS/INTERPRETATION


Incorporating the lifetime healthcare cost savings due to periods of remission from diabetes and its complications, the DiRECT intervention is predicted to be both more effective (QALY gain) and cost-saving in adults with type 2 diabetes compared with standard care. This conclusion appears robust to various less favourable model scenarios, providing strong evidence that resources could be shifted cost-effectively to support achieving remissions with the DiRECT intervention.
TRIAL REGISTRATION


ISRCTN03267836 Graphical abstract.",2020,"Intervention costs (£1411; 95% CI £1308, £1511) were partially offset by lower other healthcare costs (£796; 95% CI £150, £1465), including reduced oral glucose-lowering medications by £231 (95% CI £148, £314).","['type 2 diabetes at year 1 and 36% at year 2 in the Diabetes Remission Clinical Trial (DiRECT', 'adults with type 2 diabetes']","['DiRECT)/Counterweight-Plus weight management programme', 'Counterweight-Plus intervention in DiRECT (including training, programme materials, practitioner appointments and low-energy diet', 'weight management programme']","['life expectancy, quality of life and healthcare costs', 'healthcare costs', 'mean total lifetime cost savings', 'Mean total 2\xa0year healthcare costs', 'Net remission', 'cost per remission', 'Lifetime cost per quality-adjusted life-year (QALY', 'reduced oral glucose-lowering medications']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}]","[{'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",,0.0931155,"Intervention costs (£1411; 95% CI £1308, £1511) were partially offset by lower other healthcare costs (£796; 95% CI £150, £1465), including reduced oral glucose-lowering medications by £231 (95% CI £148, £314).","[{'ForeName': 'Yiqiao', 'Initials': 'Y', 'LastName': 'Xin', 'Affiliation': 'Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Davies', 'Affiliation': 'Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Briggs', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'McCombie', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Level 2, New Lister Building, Glasgow Royal Infirmary, 8-16 Alexandra Parade, Glasgow, G31 2ER, UK.'}, {'ForeName': 'C Martina', 'Initials': 'CM', 'LastName': 'Messow', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Grieve', 'Affiliation': 'Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Wilma S', 'Initials': 'WS', 'LastName': 'Leslie', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Level 2, New Lister Building, Glasgow Royal Infirmary, 8-16 Alexandra Parade, Glasgow, G31 2ER, UK.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Newcastle Magnetic Resonance Centre, Translational and Clinical Research Institute, Campus for Ageing and Vitality, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Michael E J', 'Initials': 'MEJ', 'LastName': 'Lean', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Level 2, New Lister Building, Glasgow Royal Infirmary, 8-16 Alexandra Parade, Glasgow, G31 2ER, UK. mike.lean@glasgow.ac.uk.'}]",Diabetologia,['10.1007/s00125-020-05224-2']
2126,32776244,A-blockers for the management of lower urinary tract symptoms in patients with prostate cancer treated with external beam radiotherapy: a randomized controlled study.,"BACKGROUND


This is a prospective study aiming to assess the efficacy of α-blockers in treating radiotherapy-induced symptoms of the lower urinary tract and its possible prophylactic role on acute urinary retention (AUR) in patients undergoing radical external beam radiotherapy (EBRT) for localized prostate cancer (PCa).
METHODS


Overall, 108 patients with localized PCa were recruited and randomly assigned in to two groups; 54 patients of Group 1 received tamsulosin 0.4 mg once daily with the initiation of EBRT and for 6 months and 54 patients of Group 2 served as the control group. All patients received radical EBRT and had post-void volume (Vres) assessment. The International Prostate Symptom Score (IPSS) questionnaire and evaluation of episodes of AUR were performed after the end of radiotherapy, at 3 and at 6 months.
RESULTS


The incidence of AUR was significantly (p = 0.027) lower in group 1 compared to group 2. No independent predictive factors for AUR were identified in regression analysis. The IPSS changes in univariate and multivariate analysis at 3 months showed significant correlation with α-blockers only, while at 6 months showed significant correlation with Vres assessments (at 3 and 6 months) and with α-blockers. Side effects due to medication were mild and none of the patients discontinued the treatment.
CONCLUSIONS


The selective use of α-blocker appears to prevent AUR in EBRT-treated patients. Although the administration of α-blockers might relieve patient-reported symptoms, there are no established independent predictive factors to distinguish patients who may benefit.",2020,The incidence of AUR was significantly (p = 0.027) lower in group 1 compared to group 2.,"['patients undergoing', 'patients with prostate cancer treated with', '54 patients of Group 2 served as the control group', '108 patients with localized PCa']","['tamsulosin', 'radical external beam radiotherapy (EBRT', 'radical EBRT', 'external beam radiotherapy']","['incidence of AUR', 'International Prostate Symptom Score (IPSS) questionnaire and evaluation of episodes of AUR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517530', 'cui_str': '108'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0341742', 'cui_str': 'Acute retention of urine'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",108.0,0.0370996,The incidence of AUR was significantly (p = 0.027) lower in group 1 compared to group 2.,"[{'ForeName': 'Kimon', 'Initials': 'K', 'LastName': 'Tsirkas', 'Affiliation': '2nd Department of Urology, School of Medicine, Sismanogleion General Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Zygogianni', 'Affiliation': '1st Department of Radiology, Radiotherapy Unit, Aretaieion Academic Hospital, School of Medicine,, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Andromachi', 'Initials': 'A', 'LastName': 'Kougioumtzopoulou', 'Affiliation': '2nd Department of Radiology, Radiotherapy Unit, ATTIKON University Hospital, School of Medicine, National and Kapodistrian University of Athens, Rimini 1, 1262, Athens, Chaidari, Greece. andromachi.kou@gmail.com.'}, {'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Kouloulias', 'Affiliation': '2nd Department of Radiology, Radiotherapy Unit, ATTIKON University Hospital, School of Medicine, National and Kapodistrian University of Athens, Rimini 1, 1262, Athens, Chaidari, Greece.'}, {'ForeName': 'Zoi', 'Initials': 'Z', 'LastName': 'Liakouli', 'Affiliation': '2nd Department of Radiology, Radiotherapy Unit, ATTIKON University Hospital, School of Medicine, National and Kapodistrian University of Athens, Rimini 1, 1262, Athens, Chaidari, Greece.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Papatsoris', 'Affiliation': '2nd Department of Urology, School of Medicine, Sismanogleion General Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Georgakopoulos', 'Affiliation': '2nd Department of Radiology, Radiotherapy Unit, ATTIKON University Hospital, School of Medicine, National and Kapodistrian University of Athens, Rimini 1, 1262, Athens, Chaidari, Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Antypas', 'Affiliation': '1st Department of Radiology, Radiotherapy Unit, Aretaieion Academic Hospital, School of Medicine,, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Armpillia', 'Affiliation': '1st Department of Radiology, Radiotherapy Unit, Aretaieion Academic Hospital, School of Medicine,, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Dellis', 'Affiliation': '2nd Department of Surgery, Aretaieion Academic Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}]",World journal of urology,['10.1007/s00345-020-03398-3']
2127,32776286,The Silent Operation Theatre Optimisation System (SOTOS © ) to reduce noise pollution during da Vinci robot-assisted laparoscopic radical prostatectomy.,"To reduce noise pollution and consequently stress during robot-assisted laparoscopic radical prostatectomy (RALP) the aim of our study was to evaluate the silent operation theatre optimisation system (SOTOS) in its effectiveness. In the operating room (OR) the noise level is between 80 and 85 decibel (dB). Noise corresponds to a major stress factor for surgical teams and especially surgeons. The use of the da Vinci surgical system entails an additional aspect of noise in the OR. The SOTOS surgical team used wired or wireless headphone/microphone combinations to communicate. We measured sound pressure levels in two different locations in the OR and the heart rate of every surgical team member as an indicator of the stress level. We further captured subjective acceptance of SOTOS as well as perioperative data such as surgical time. We prospectively randomised 32 RALP patients into two study arms. Sixteen surgeries were performed using SOTOS and 16 without (control). Overall, the mean sound pressure level in the SOTOS group was 3.6 dB lower compared to the control (p < 0.001). The highest sound pressure level measured was 96 dB in the control group. Mean heart rates were 81.3 beats/min for surgeons and 90.8 beats/min for circulating nurses. SOTOS had no statistically significant effect on mean heart rates of the operating team. Subjective acceptance of SOTO was high. Our prospective evaluation of SOTOS in RALP could show a significant noise reduction in the OR and a high acceptance by the surgical stuff.",2020,"Overall, the mean sound pressure level in the SOTOS group was 3.6 dB lower compared to the control (p < 0.001).",['32 RALP patients into two study arms'],"['robot-assisted laparoscopic radical prostatectomy (RALP', 'Vinci robot-assisted laparoscopic radical prostatectomy']","['mean sound pressure level', 'highest sound pressure level', 'Subjective acceptance of SOTO', 'sound pressure levels', 'mean heart rates', 'Mean heart rates']","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C4039115', 'cui_str': 'Robot assisted laparoscopic radical prostatectomy'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.0155837,"Overall, the mean sound pressure level in the SOTOS group was 3.6 dB lower compared to the control (p < 0.001).","[{'ForeName': 'Conrad', 'Initials': 'C', 'LastName': 'Leitsmann', 'Affiliation': 'Department of Urology, University Medical Center Goettingen, Robert-Koch-Straße 40, 37075, Goettingen, Germany. conrad.leitsmann@med.uni-goettingen.de.'}, {'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Uhlig', 'Affiliation': 'Department of Urology, University Medical Center Goettingen, Robert-Koch-Straße 40, 37075, Goettingen, Germany.'}, {'ForeName': 'I Valentin', 'Initials': 'IV', 'LastName': 'Popeneciu', 'Affiliation': 'Department of Urology, University Medical Center Goettingen, Robert-Koch-Straße 40, 37075, Goettingen, Germany.'}, {'ForeName': 'Margarete', 'Initials': 'M', 'LastName': 'Boos', 'Affiliation': 'Department of Social and Communication Psychology, Georg-Elias-Mueller-Institute of Psychology, University of Goettingen, Goettingen, Germany.'}, {'ForeName': 'Sascha A', 'Initials': 'SA', 'LastName': 'Ahyai', 'Affiliation': 'Department of Urology, University Medical Center Goettingen, Robert-Koch-Straße 40, 37075, Goettingen, Germany.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Schmid', 'Affiliation': 'Department of Urology, University Medical Center Goettingen, Robert-Koch-Straße 40, 37075, Goettingen, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Wachter', 'Affiliation': 'Clinic for Cardiology and Pneumology, University Medical Center Goettingen, Goettingen, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Trojan', 'Affiliation': 'Department of Urology, University Medical Center Goettingen, Robert-Koch-Straße 40, 37075, Goettingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Friedrich', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, University Medical Center Goettingen, Goettingen, Germany.'}]",Journal of robotic surgery,['10.1007/s11701-020-01135-x']
2128,32776296,"The effects of a music and singing intervention during pregnancy on maternal well-being and mother-infant bonding: a randomised, controlled study.","PURPOSE


Stress and impaired mother-infant bonding during pregnancy can lead to adverse effects for the expectant mother and the unborn child. The present study investigates whether a prenatal music and singing intervention can improve maternal well-being as well as mother-infant bonding.
METHODS


A total of 172 pregnant women took part in this prospective, randomised, three-armed (music, singing or control group) study. Depressive symptoms, self-efficacy, maternal well-being and mother-infant bonding were assessed with visual analogue scales and questionnaires before the intervention phase (30th week of gestation) and afterwards (36th week of gestation). Additionally, immediate changes regarding experienced stress and mood from before until after the music and singing interventions were explored with questionnaires as well as saliva samples (for cortisol, alpha-amylase and oxytocin determination).
RESULTS


Regarding immediate effects, both interventions showed positive effects on the emotional state, stress (cortisol) and bonding (oxytocin). Additionally, the singing group showed a larger reduction in cortisol and a larger improvement in valence than the music group. Looking at more prolonged effects, significant effects on general self-efficacy and perceived closeness to the unborn child (measured with a visual analogue scale) were found. No significant effects were revealed for the mother-infant bonding questionnaire and for depressive symptoms.
CONCLUSION


In the present study, promising effects of music and in particular singing on maternal well-being and perceived closeness during pregnancy appeared. Prenatal music and singing interventions could be an easy to implement and effective addition to improve mood and well-being of the expectant mother and support mother-infant bonding.
TRIAL REGISTRATION NUMBER


DRKS00012822, date of registration: 17.10.2017.",2020,"Regarding immediate effects, both interventions showed positive effects on the emotional state, stress (cortisol) and bonding (oxytocin).",['172 pregnant women'],"['music and singing intervention', 'Prenatal music and singing interventions', 'prenatal music and singing intervention']","['Depressive symptoms, self-efficacy, maternal well-being and mother-infant bonding', 'mother-infant bonding questionnaire and for depressive symptoms', 'larger reduction in cortisol', 'emotional state, stress (cortisol) and bonding (oxytocin', 'general self-efficacy and perceived closeness to the unborn child (measured with a visual analogue scale']","[{'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",172.0,0.0845289,"Regarding immediate effects, both interventions showed positive effects on the emotional state, stress (cortisol) and bonding (oxytocin).","[{'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Wulff', 'Affiliation': 'Department of Experimental Psychology, Heinrich-Heine-University Düsseldorf, Universitätsstraße 1, 40225, Düsseldorf, Germany. verena.wulff@hhu.de.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Hepp', 'Affiliation': 'Clinic for Gynecology and Obstetrics, University Clinic, Augsburg, Germany.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Wolf', 'Affiliation': 'Department of Cognitive Psychology, Institute of Cognitive Neuroscience, Faculty of Psychology, Ruhr-University, Bochum, Germany.'}, {'ForeName': 'Percy', 'Initials': 'P', 'LastName': 'Balan', 'Affiliation': 'Clinic for Gynecology and Obstetrics, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Hagenbeck', 'Affiliation': 'Clinic for Gynecology and Obstetrics, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Fehm', 'Affiliation': 'Clinic for Gynecology and Obstetrics, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Nora K', 'Initials': 'NK', 'LastName': 'Schaal', 'Affiliation': 'Department of Experimental Psychology, Heinrich-Heine-University Düsseldorf, Universitätsstraße 1, 40225, Düsseldorf, Germany.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05727-8']
2129,32776489,Outcomes in children with hemophilia A with inhibitors: Results from a noninterventional study.,"BACKGROUND


Data regarding management of pediatric persons with hemophilia A (PwHA) with factor VIII (FVIII) inhibitors are limited. This prospective noninterventional study (NCT02476942) evaluated annualized bleeding rates (ABRs), safety, and health-related quality of life (HRQoL) in pediatric PwHA with FVIII inhibitors.
PROCEDURE


PwHA aged <12 years with current FVIII inhibitors and high-titer inhibitor history were enrolled. Participants remained on usual treatment; no interventions were applied. Outcomes included ABR, safety, and HRQoL.
RESULTS


Twenty-four PwHA aged 2-11 years (median 7.5) were enrolled and monitored for 8.7-44.1 weeks (median 23.4). In the episodic (n = 10) and prophylactic (n = 14) groups, respectively, 121 of 185 (65.4%) and 101 of 186 (54.3%) bleeds were treated using activated prothrombin complex concentrate (aPCC) and/or recombinant activated FVII (rFVIIa). ABRs (95% confidence interval) were 19.4 (13.2-28.4) and 18.5 (14.2-24.0) for treated bleeds, and 32.7 (20.5-52.2) and 33.1 (22.4-48.9) for all bleeds, respectively. Most prophylactic group participants (92.9%) were prescribed aPCC; 50% adhered to their prescribed treatment regimen. Adherence to prophylactic rFVIIa was not assessed. Serious adverse events included hemarthrosis (12.5%) and mouth hemorrhage (12.5%); the most common nonserious adverse event was viral upper respiratory tract infection (12.5%). HRQoL showed functional impairment at baseline; scores remained stable throughout, with little intergroup variation.
CONCLUSIONS


ABRs remained high in pediatric PwHA with inhibitors receiving standard treatment. This study demonstrates the need for more effective treatments, with reduced treatment burden, to prevent bleeds, increase prophylaxis adherence, and improve patient outcomes.",2020,Serious adverse events included hemarthrosis (12.5%) and mouth hemorrhage (12.5%); the most common nonserious adverse event was viral upper respiratory tract infection (12.5%).,"['PwHA aged <12\xa0years with current FVIII inhibitors and high-titer inhibitor history were enrolled', 'children with hemophilia A with inhibitors', 'pediatric persons with hemophilia A (PwHA) with factor VIII']",['activated prothrombin complex concentrate (aPCC) and/or recombinant activated FVII (rFVIIa'],"['annualized bleeding rates (ABRs), safety, and health-related quality of life (HRQoL', 'ABRs', 'mouth hemorrhage', 'ABR, safety, and HRQoL']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0368953', 'cui_str': 'Factor VIII antibody'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0472802', 'cui_str': 'Hereditary factor VIII deficiency disease with inhibitor'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0015506', 'cui_str': 'Factor VIII'}]","[{'cui': 'C0358606', 'cui_str': 'Coagulation factor II- and coagulation factor IX- and coagulation factor VIIa- and coagulation factor VIII- and coagulation factor X-containing product'}, {'cui': 'C0534191', 'cui_str': 'Eptacog alfa'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0029163', 'cui_str': 'Bleeding from mouth'}]",,0.101006,Serious adverse events included hemarthrosis (12.5%) and mouth hemorrhage (12.5%); the most common nonserious adverse event was viral upper respiratory tract infection (12.5%).,"[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Oldenburg', 'Affiliation': 'Institute of Experimental Hematology and Transfusion Medicine, Universitätsklinikum Bonn, Bonn, Germany.'}, {'ForeName': 'Midori', 'Initials': 'M', 'LastName': 'Shima', 'Affiliation': 'Department of Pediatrics, Nara Medical University, Nara, Japan.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kruse-Jarres', 'Affiliation': 'Washington Center for Bleeding Disorders at Bloodworks Northwest, University of Washington, Seattle, Washington.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Santagostino', 'Affiliation': ""Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Milan, Italy.""}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Mahlangu', 'Affiliation': 'Haemophilia Comprehensive Care Centre, Faculty of Health Sciences, University of the Witwatersrand and NHLS, Johannesburg, South Africa.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Lehle', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Nives', 'Initials': 'N', 'LastName': 'Selak Bienz', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Sammy', 'Initials': 'S', 'LastName': 'Chebon', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Asikanius', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Trask', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Maria Elisa', 'Initials': 'ME', 'LastName': 'Mancuso', 'Affiliation': ""Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Milan, Italy.""}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Jiménez-Yuste', 'Affiliation': 'Hospital Universitario La Paz, Autonoma University, Madrid, Spain.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'von Mackensen', 'Affiliation': 'University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Gallia G', 'Initials': 'GG', 'LastName': 'Levy', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}]",Pediatric blood & cancer,['10.1002/pbc.28474']
2130,32776493,Work volume is an important variable in determining the degree of inhibitory control improvements following resistance exercise.,"We previously determined that improvement in cognitive inhibitory control (IC) immediately after localized resistance exercise was greater for high-intensity resistance exercise (HRE) than for low-intensity resistance exercise (LRE). However, our previous study used the same total repetitions (i.e., same repetitions per set) between HRE and LRE; therefore, the difference in postexercise IC improvement might be due to a difference in work volume (i.e., intensity × total repetitions). In this study, we compared the effect of high-volume (HV)-LRE to that of volume-matched HRE on postexercise IC improvements. Twenty-two healthy, young males performed both HV-LRE and HRE in a crossover design. Exercise loads for HV-LRE and HRE were set at 35% and 70% of one-repetition maximum, respectively. The bilateral knee extension exercises for HV-LRE and HRE were programmed for six sets with 20 and 10 repetitions, respectively, per set. IC was measured using the color-word Stroop task (CWST) at six time points; baseline, pre-exercise, immediate postexercise, and every 10 min during the 30-min postexercise recovery period. The reverse-Stroop interference score decreased significantly immediately after HV-LRE and HRE compared with that before each exercise (decreasing rate >34 and >38%, respectively, vs. baseline and pre-exercise; all ps < .05), and the decreased score remained significant until 20 min after both protocols (decreasing rate >40 and >38%, respectively, vs. baseline and pre-exercise; all ps < .05). The degree of the postexercise IC improvements did not differ significantly between the two protocols. These findings suggest that HV-LRE improves IC in a similar manner to volume-matched HRE.",2020,"The reverse-Stroop interference score decreased significantly immediately after HV-LRE and HRE compared with that before each exercise (decreasing rate >34 and >38%, respectively, vs. baseline and pre-exercise; all ps < .05), and the decreased score remained significant until 20 min after both protocols (decreasing rate >40 and >38%, respectively, vs. baseline and pre-exercise; all ps < .05).","['Twenty-two healthy, young males']","['high-volume (HV)-LRE', 'high-intensity resistance exercise (HRE) than for low-intensity resistance exercise (LRE', 'HV-LRE', 'HV-LRE and HRE']","['cognitive inhibitory control (IC', 'color-word Stroop task (CWST', 'reverse-Stroop interference score', 'postexercise IC improvements']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0366097,"The reverse-Stroop interference score decreased significantly immediately after HV-LRE and HRE compared with that before each exercise (decreasing rate >34 and >38%, respectively, vs. baseline and pre-exercise; all ps < .05), and the decreased score remained significant until 20 min after both protocols (decreasing rate >40 and >38%, respectively, vs. baseline and pre-exercise; all ps < .05).","[{'ForeName': 'Keigo', 'Initials': 'K', 'LastName': 'Tomoo', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Suga', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sugimoto', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Tanaka', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Kento', 'Initials': 'K', 'LastName': 'Shimoho', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Kento', 'Initials': 'K', 'LastName': 'Dora', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Mok', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Neuroscience, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Hayato', 'Initials': 'H', 'LastName': 'Tsukamoto', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Takada', 'Affiliation': 'Department of Sports Education, Faculty of Lifelong Sport, Hokusho University, Ebetsu, Hokkaido, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Hashimoto', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Isaka', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}]",Physiological reports,['10.14814/phy2.14527']
2131,32776518,Measurement of airway pressure during high-flow nasal therapy in apnoeic oxygenation: a randomised controlled crossover trial .,"It is recognised that high-flow nasal therapy can prevent desaturation during airway management. Studies in spontaneously breathing patients show an almost linear relationship between flow rate and positive airway pressure in the nasopharynx. Positive airway pressure has been suggested as one of the possible mechanisms explaining how high-flow nasal therapy works. However, data on pressures generated by high-flow nasal therapy in apnoeic adults under general anaesthesia are absent. This randomised controlled crossover trial investigated airway pressures generated by different flow rates during high-flow nasal therapy in anaesthetised and paralysed apnoeic patients, comparing pressures with closed and open mouths. Following induction of anaesthesia and neuromuscular blockade, a continuous jaw thrust was used to enable airway patency. Airway pressure was measured in the right main bronchus, the middle of the trachea and the pharynx, using a fibreoptically-placed catheter connected to a pressure transducer. Each measurement was randomised with respect to closed or open mouth and different flow rates. Twenty patients undergoing elective surgery were included (mean (SD) age 38 (18) years, BMI 25.0 (3.3) kg.m -2  , nine women, ASA physical status 1 (35%), 2 (55%), 3 (10%). While closed mouths and increasing flow rates demonstrated non-linear increases in pressure, the pressure increase was negligible with an open mouth. Airway pressures remained below 10 cmH 2  O even with closed mouths and flow rates up to 80 l.min -1  ; they were not influenced by catheter position. This study shows an increase in airway pressures with closed mouths that depends on flow rate. The generated pressure is negligible with an open mouth. These data question positive airway pressure as an important mechanism for maintenance of oxygenation during apnoea.",2020,Airway pressures remained below 10 cmH 2  O even with closed mouths and flow rates up to 80 l.min -1  ; they were not influenced by catheter position.,"['apnoeic oxygenation', 'Twenty patients undergoing elective surgery were included (mean (SD) age 38 (18', 'anaesthetised and paralysed apnoeic patients', 'spontaneously breathing patients']","['airway pressure during high-flow nasal therapy', 'anaesthesia and neuromuscular blockade']","['flow rate and positive airway pressure', 'Airway pressure', 'Airway pressures', 'airway pressures']","[{'cui': 'C0475745', 'cui_str': 'Apneic oxygenation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0522224', 'cui_str': 'Paralysis'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}]",,0.0445496,Airway pressures remained below 10 cmH 2  O even with closed mouths and flow rates up to 80 l.min -1  ; they were not influenced by catheter position.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Riva', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Meyer', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Theiler', 'Affiliation': 'Department of Anaesthesia, Kantonsspital Aarau, Switzerland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Obrist', 'Affiliation': 'ARTORG Center for Biomedical Engineering Research, University of Bern, Switzerland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bütikofer', 'Affiliation': 'CTU Bern, University of Bern, Switzerland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Greif', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nabecker', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Bern University Hospital, University of Bern, Switzerland.'}]",Anaesthesia,['10.1111/anae.15224']
2132,32776533,One-year results of 0.01% atropine with orthokeratology (AOK) study: a randomised clinical trial.,"PURPOSE


To report the 1-year results of an investigation into whether there is an additive effect between 0.01% atropine and orthokeratology (ortho-k), in a single-masked, two-arm, randomised controlled trial: Combined Atropine with Orthokeratology (AOK) for myopia control study (ClinicalTrials.gov number: NCT02955927).
METHODS


Chinese children aged between 6 and 11 years with 1.00-4.00 D of myopia, astigmatism <2.50 D, and no more than 1.00 D anisometropia, were randomly assigned either to an AOK group or ortho-k only (OK) group at a 1:1 ratio. Subjects in the AOK group instilled one drop of 0.01% atropine into each eye, 10 min before nightly wear of ortho-k lenses. The primary outcome, axial elongation, was examined at 6-monthly intervals, along with secondary outcomes including best-corrected visual acuity (BCVA), manifest refraction, accommodation, pupil size, and corneal topography.
RESULTS


29 AOK and 30 OK subjects completed the 1-year visit. The overall axial elongation rate was significantly slower in the AOK group than in the OK group (mean (S.D.), 0.07 (0.16) mm vs 0.16 (0.15) mm, respectively; p = 0.03). A significant between-group difference in axial elongation was observed over the first 6-month period only (p < 0.001), but not over the second period (p = 0.818). At the 1-year visit, increases in mean (S.D.) mesopic and photopic pupil sizes in the AOK group were 0.64 (0.48) mm and 0.36 (0.34) mm, respectively, which were significantly higher than 0.10 (0.50) mm and 0.02 (0.28) mm in the OK group (p < 0.001). At the 6-month visit, a significant moderate negative correlation was found between axial elongation and the increase in photopic pupil size (r = -0.42, p = 0.02) in the AOK group.
CONCLUSIONS


There is an additive effect between 0.01% atropine and ortho-k over one year, with mean axial elongation in the AOK group 0.09 mm slower than that in the OK group. It appears that the additive effect was only during the first six months; a second-year investigation is warranted to determine whether the effect is sustained over time.",2020,"The overall axial elongation rate was significantly slower in the AOK group than in the OK group (mean (S.D.), 0.07 (0.16) mm vs 0.16 (0.15) mm, respectively; p =","['Chinese children aged between 6 and 11\xa0years with 1.00-4.00 D of myopia, astigmatism <2.50 D, and no more than 1.00 D anisometropia']","['AOK group or ortho-k only (OK', 'atropine and orthokeratology (ortho-k', 'Atropine with Orthokeratology (AOK', 'atropine', 'atropine with orthokeratology']","['overall axial elongation rate', 'mean (S.D.) mesopic and photopic pupil sizes', 'mean axial elongation', 'photopic pupil size', 'best-corrected visual acuity (BCVA), manifest refraction, accommodation, pupil size, and corneal topography', 'axial elongation']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0003081', 'cui_str': 'Anisometropia'}]","[{'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0517965', 'cui_str': 'Size of pupil'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C1301318', 'cui_str': 'Subjective refraction'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0524957', 'cui_str': 'Corneal topography'}]",,0.168199,"The overall axial elongation rate was significantly slower in the AOK group than in the OK group (mean (S.D.), 0.07 (0.16) mm vs 0.16 (0.15) mm, respectively; p =","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Tan', 'Affiliation': 'School of Optometry, The Hong Kong Polytechnic University, Kowloon, Hong Kong SAR, China.'}, {'ForeName': 'Alex Lk', 'Initials': 'AL', 'LastName': 'Ng', 'Affiliation': 'Department of Ophthalmology, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Bonnie Nk', 'Initials': 'BN', 'LastName': 'Choy', 'Affiliation': 'Department of Ophthalmology, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'George Pm', 'Initials': 'GP', 'LastName': 'Cheng', 'Affiliation': 'Hong Kong Laser Eye Centre, Hong Kong SAR, China.'}, {'ForeName': 'Victor Cp', 'Initials': 'VC', 'LastName': 'Woo', 'Affiliation': 'Department of Ophthalmology, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Cho', 'Affiliation': 'School of Optometry, The Hong Kong Polytechnic University, Kowloon, Hong Kong SAR, China.'}]",Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists),['10.1111/opo.12722']
2133,32776564,Sexual dysfunction in Indian men undergoing Double J ureteral stenting following ureteroscopy-A prospective analysis.,"This prospective study was aimed to evaluate the impact of an indwelling ureteral double-J stent on the sexual health of Indian men undergoing ureteroscopy. The first phase of the study included 30 men who were not counselled prior to stenting about possible sexual dysfunction, while in the next phase, 60 men were counselled about this. These 60 patients were assessed by a 6-point questionnaire: five questions from the International Index of Erectile Function-5 (IIEF-5) and an additional 6th question to assess pain during erection/ejaculation. Patients answered the questionnaire prior to ureteroscopy, at the time of stent removal and then 4 weeks after stent removal. A higher proportion of men in the second phase attempted sexual activity (68.3% vs. 26.7%; p < .001). Significant changes were noted in the total IIEF-5 score (mean 23.16 before vs. 15.65 after, p < .001) and individual IIEF-5 components: erection confidence (4.59 vs. 2.76, p = .017), maintenance ability (4.67 vs. 2.43, p = .006) and intercourse satisfaction (4.61 vs. 2.31, p < .001) and also the 'pain' question (2.83 post-stenting vs. 0.37 pre-stenting, p < .001). Most patients had a recovery of scores at 4 weeks after stent removal. Thus, ureteral DJ stenting leads to significant but temporary sexual dysfunction and patients need to be counselled regarding this.",2020,"Significant changes were noted in the total IIEF-5 score (mean 23.16 before vs. 15.65 after, p < .001) and individual IIEF-5 components: erection confidence (4.59 vs. 2.76, p = .017), maintenance ability (4.67 vs. 2.43, p = .006) and intercourse satisfaction (4.61 vs. 2.31, p < .001) and also the 'pain' question (2.83 post-stenting vs. 0.37 pre-stenting, p < .001).","['Indian men undergoing ureteroscopy', '30 men who were not counselled prior to stenting about possible sexual dysfunction, while in the next phase, 60 men were counselled about this', 'Indian men undergoing']","['Double J ureteral stenting', 'indwelling ureteral double-J stent', 'ureteral DJ stenting']","['sexual activity', 'Sexual dysfunction', 'individual IIEF-5 components: erection confidence', ""pain' question"", 'total IIEF-5 score', 'intercourse satisfaction', 'maintenance ability', 'pain during erection/ejaculation']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1522613', 'cui_str': 'Ureteral route'}, {'cui': 'C0439848', 'cui_str': 'Indwelling'}, {'cui': 'C0441293', 'cui_str': 'JJ-stent'}, {'cui': 'C0038257', 'cui_str': 'Stent'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}]",60.0,0.0880097,"Significant changes were noted in the total IIEF-5 score (mean 23.16 before vs. 15.65 after, p < .001) and individual IIEF-5 components: erection confidence (4.59 vs. 2.76, p = .017), maintenance ability (4.67 vs. 2.43, p = .006) and intercourse satisfaction (4.61 vs. 2.31, p < .001) and also the 'pain' question (2.83 post-stenting vs. 0.37 pre-stenting, p < .001).","[{'ForeName': 'Amandeep', 'Initials': 'A', 'LastName': 'Arora', 'Affiliation': 'Department of Urology, Fortis Hospital Mulund, Mumbai, India.'}, {'ForeName': 'Mahesh S', 'Initials': 'MS', 'LastName': 'Sane', 'Affiliation': 'Department of Urology, Fortis Hospital Mulund, Mumbai, India.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Jadhao', 'Affiliation': 'Department of Urology, Fortis Hospital Mulund, Mumbai, India.'}, {'ForeName': 'Pankaj N', 'Initials': 'PN', 'LastName': 'Maheshwari', 'Affiliation': 'Department of Urology, Fortis Hospital Mulund, Mumbai, India.'}]",Andrologia,['10.1111/and.13790']
2134,32776649,The benefits of mechanical insufflator-exsufflator (MI-E) compared to autogenic drainage (AD) in adults with Cystic Fibrosis (CF).,"BACKGROUND


Autogenic drainage (AD) is used for airway clearance in individuals with Cystic fibrosis (CF). The Mechanical Insufflator-Exsufflator (MI-E) device is commonly used in patients with neuromuscular diseases for airway clearance by increasing inspiratory volume and expiratory flow. MI-E use has not been studied extensively in CF patients.
OBJECTIVES


To examine whether there are advantages to using the MI-E device in patients with CF.
SUBJECTS


14 males and 8 females from the national center for CF, with an average FEV 1  of 54% were recruited DESIGN: Prospective cross-over trial (IRB 3009-16-SMC).
INTERVENTION


Subjects received either AD or MI-E in a random order. Sputum was collected and weighed immediately after treatment. Subjects performed lung function tests at baseline, 20 minutes after and 1 hour after treatment; additionally, a two-minute walk test was performed at the end of all lung function tests. Saturation, dyspnea scores while resting and after a 2-minute walk and subjective fatigue were recorded.
RESULTS


36% more sputum was collected following MI-E than AD treatment (P<0.0001). A significant difference in saturation in response to the 2MWT was noted in both treatments significantly less desaturation was recorded after the 2MWT in the MI-E treatment (P<0.01).
CONCLUSIONS


Treatment with the MI-E was more effective for clearing sputum in CF subjects, initial evidence suggests that the MI-E may be successfully incorporated into treatment protocols. Further studies are needed to assess the long-term benefits of MI-E in patients with CF. This article is protected by copyright. All rights reserved.",2020,"A significant difference in saturation in response to the 2MWT was noted in both treatments significantly less desaturation was recorded after the 2MWT in the MI-E treatment (P<0.01).
","['individuals with Cystic fibrosis (CF', 'adults with Cystic Fibrosis (CF', 'patients with neuromuscular diseases', '14 males and 8 females from the national center for CF, with an average FEV 1  of 54% were recruited DESIGN', 'patients with CF']","['autogenic drainage (AD', 'mechanical insufflator-exsufflator (MI-E', 'AD or MI-E', 'Autogenic drainage (AD']","['Saturation, dyspnea scores while resting and after a 2-minute walk and subjective fatigue', 'lung function tests', 'saturation in response to the 2MWT']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027868', 'cui_str': 'Myoneural disorder'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0454507', 'cui_str': 'Autogenic pulmonary drainage'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0021639', 'cui_str': 'Insufflator'}]","[{'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",14.0,0.0189022,"A significant difference in saturation in response to the 2MWT was noted in both treatments significantly less desaturation was recorded after the 2MWT in the MI-E treatment (P<0.01).
","[{'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Helper', 'Affiliation': ""Pediatric Pulmonary Unit, The National Center for Cystic Fibrosis. The Edmond and Lily Safra Children's Hospital, Sheba Medical Center, Ramat Gan, Israel.""}, {'ForeName': 'Einat', 'Initials': 'E', 'LastName': 'Kodesh', 'Affiliation': 'Physical Therapy Department, Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Sokol', 'Affiliation': ""Pediatric Pulmonary Unit, The National Center for Cystic Fibrosis. The Edmond and Lily Safra Children's Hospital, Sheba Medical Center, Ramat Gan, Israel.""}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Hakimi', 'Affiliation': ""Pediatric Pulmonary Unit, The National Center for Cystic Fibrosis. The Edmond and Lily Safra Children's Hospital, Sheba Medical Center, Ramat Gan, Israel.""}, {'ForeName': 'Daphna', 'Initials': 'D', 'LastName': 'Vilozni', 'Affiliation': ""Pediatric Pulmonary Unit, The National Center for Cystic Fibrosis. The Edmond and Lily Safra Children's Hospital, Sheba Medical Center, Ramat Gan, Israel.""}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Efrati', 'Affiliation': ""Pediatric Pulmonary Unit, The National Center for Cystic Fibrosis. The Edmond and Lily Safra Children's Hospital, Sheba Medical Center, Ramat Gan, Israel.""}]",Pediatric pulmonology,['10.1002/ppul.25020']
2135,32776693,"Break Binge Eating: Reach, engagement, and user profile of an Internet-based psychoeducational and self-help platform for eating disorders.","OBJECTIVES


Internet-based psychoeducational and self-help platforms hold promise for alleviating existing help-seeking barriers and addressing the unmet needs of people with eating disorders (EDs). In this paper, we report data related to the reach, engagement, and visitor profile of Break Binge Eating, an online platform designed to provide evidence-based information and self-help strategies for people at all stages of an ED.
METHOD


Two sources of data were presented: (a) usage data from platform visitors generated through Google Analytics; and (b) characteristics of a sample of platform visitors (n = 786).
RESULTS


In 13 months, approximately 46,311 unique users worldwide have accessed this platform, with usage rates rapidly increasing each month. Most visitors came from organic searches (when ED-related information is directly searched in a browser). Self-help content was the most accessed material, and 81% of the sample stated that their reason for accessing the platform was to get help. Sample visitors were highly symptomatic; 52% met criteria resembling a threshold ED and 87% engaged in at least one ED behavior in the past month. Across different symptomatic subgroups, ∼50% were unsure whether they needed help, ∼80% were not receiving any help, and ∼75% were highly concerned with their symptoms.
CONCLUSION


This online platform has broad reach and is engaging its intended audience. It is an aim of this platform to improve mental health literacy, facilitate symptom recognition and improvement, and alleviate help-seeking barriers. Evaluating whether this platform is achieving its intended aims in a randomized controlled trial is the next step.",2020,"Across different symptomatic subgroups, ∼50% were unsure whether they needed help, ∼80% were not receiving any help, and ∼75% were highly concerned with their symptoms.
","['people at all stages of an ED', 'people with eating disorders (EDs']",[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}]",[],[],,0.0988506,"Across different symptomatic subgroups, ∼50% were unsure whether they needed help, ∼80% were not receiving any help, and ∼75% were highly concerned with their symptoms.
","[{'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Linardon', 'Affiliation': 'School of Psychology, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rosato', 'Affiliation': 'School of Psychology, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Mariel', 'Initials': 'M', 'LastName': 'Messer', 'Affiliation': 'School of Psychology, Deakin University, Geelong, Victoria, Australia.'}]",The International journal of eating disorders,['10.1002/eat.23356']
2136,32776698,"Progressive task-oriented circuit training for cognition, physical functioning and societal participation in individuals with dementia.","BACKGROUND AND OBJECTIVES


Dementia is commonly associated with cognitive deficit, functional decline and societal participation restriction across multiple domains of functioning. The decline impacts not only on the individual, but also on their informal caregivers, healthcare and the social system. This clinical random controlled study investigated the efficacy of 12-week Progressive Task-oriented circuit training on cognition, physical functioning and societal participation of individuals with dementia.
METHODS


This study involved 31 individuals living with dementia recruited from a tertiary health institution in Lagos Nigeria. They were randomized into two groups: Progressive Task-oriented circuit training (involved in 12-week circuit training, two times a week for 70 min per session consisting of six workstations) and Control group (training with conventional treatment and home programmes). They were assessed at baseline, mid-intervention and post-intervention using Mini-Mental State Examination (MMSE), Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog), Bristol ADLs, Community integration Questionnaire, 6-min walk test. Data analysed using the independent-samples t tests, paired t tests, Friedman two-way analysis of variance and Mann-Whitney U test (p ≤ .05).
RESULTS


Participants were aged 69.61 ± 3.44 years. There was significant improvement from baseline to post-intervention in cognition (30.77 ± 1.02 vs. 28.77 ± 3.30), physical functioning (28.19 ± 3.90 vs. 25.84 ± 6.26) and societal participation (3.64 ± 0.73 vs. 5.59 ± 2.76). However, the progressive Task-oriented circuit training had more significant improvement than the control group within the group in cognition (p = .000), physical functioning (p = .000), and societal participation (p = .000). There was no statistical difference within the Control group with cognition (p = .097), Physical functioning (p = 1.000). Meanwhile there was statistically significant effect between both groups on cognition, physical functioning and societal participation post-intervention (p < .005).
CONCLUSION


Although both Task-oriented Circuit Training and conventional treatment with home exercise programmes are efficacious, Progressive Task-oriented Circuit Training is more efficacious in enhancing and developing therapeutic strategies to train cognition, improve functional performance and societal participation in the rehabilitation of individuals with dementia.",2020,"There was no statistical difference within the Control group with cognition (p = .097), Physical functioning (p = 1.000).","['individuals with dementia', 'Participants were aged 69.61\u2009±\u20093.44\u2009years', '31 individuals living with dementia recruited from a tertiary health institution in Lagos Nigeria']","['Control group (training with conventional treatment and home programmes', 'Progressive Task-oriented circuit training', 'Progressive task-oriented circuit training']","['societal participation', ""Mini-Mental State Examination (MMSE), Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog), Bristol ADLs, Community integration Questionnaire, 6-min walk test"", 'Physical functioning', 'physical functioning', 'cognition, physical functioning and societal participation post-intervention']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}]","[{'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C3494302', 'cui_str': 'Community Integration'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",31.0,0.0161671,"There was no statistical difference within the Control group with cognition (p = .097), Physical functioning (p = 1.000).","[{'ForeName': 'Caleb Ademola Omuwa', 'Initials': 'CAO', 'LastName': 'Gbiri', 'Affiliation': 'Department of Physiotherapy, Stroke and Nervous System Disorders Research Group, College of Medicine, University of Lagos, Lagos, Nigeria.'}, {'ForeName': 'Biliafeez Francisca', 'Initials': 'BF', 'LastName': 'Amusa', 'Affiliation': 'Department of Physiotherapy, Lagos State University Teaching Hospital, Lagos, Nigeria.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1866']
2137,32776853,Association of Race and Ethnicity with Sedation Management in Pediatric Intensive Care.,"RATIONALE


Racial disparities in pain management have been previously reported for children receiving emergency care.
OBJECTIVE


We aimed to determine whether patient race or ethnicity is associated with the broader goal of pain management and sedation among pediatric patients mechanically ventilated for acute respiratory failure.
METHODS


Planned secondary analysis of Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE). RESTORE, a cluster randomized clinical trial conducted in 31 United States pediatric intensive care units, compared protocolized sedation management (intervention arm) to usual care (control arm). Participants included 2271 children identified as non-Hispanic White (White, n=1233), non-Hispanic Black (Black, n=502), and Hispanic children of any race (Hispanic, n=536).
RESULTS


Within each treatment arm, neither opioid nor benzodiazepine selection, nor cumulative dosing, differed significantly between race/ethnicity groups. Black patients experienced fewer days with an episode of pain (compared to White patients in the control arm and to Hispanic patients in the intervention arm) and experienced less iatrogenic withdrawal syndrome (compared to White patients in either arm or Hispanic patients in the intervention arm). The percentage of days awake/calm while intubated was not significantly different in pairwise comparisons by race/ethnicity groups in either the control arm (White: median, 75%; Black: 71%; Hispanic: 75%) or the intervention arm (White: 86%; Black: 88%; Hispanic: 85%).
CONCLUSIONS


Across multiple measures, our study found scattered differences in sedation management between critically ill Black, Hispanic, and White children that did not consistently favor any group. However, racial disparities related to implicit bias cannot be completely ruled out. Clinical trial registered with ClinicalTrials.gov (NCT00814099).",2020,"The percentage of days awake/calm while intubated was not significantly different in pairwise comparisons by race/ethnicity groups in either the control arm (White: median, 75%; Black: 71%; Hispanic: 75%) or the intervention arm (White: 86%; Black: 88%; Hispanic: 85%).
","['Pediatric Intensive Care', 'Participants included 2271 children identified as non-Hispanic White (White, n=1233), non-Hispanic Black (Black, n=502), and Hispanic children of any race (Hispanic, n=536', '31 United States pediatric intensive care units, compared', 'pediatric patients mechanically ventilated for acute respiratory failure', 'children receiving emergency care']","['Sedation Titration', 'protocolized sedation management (intervention arm) to usual care (control arm']","['episode of pain', 'iatrogenic withdrawal syndrome', 'percentage of days awake/calm while intubated']","[{'cui': 'C1627360', 'cui_str': 'Pediatric intensive care'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C1320388', 'cui_str': 'Sedation management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038587', 'cui_str': 'Withdrawal syndrome'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0150157', 'cui_str': 'Calming'}]",2271.0,0.106025,"The percentage of days awake/calm while intubated was not significantly different in pairwise comparisons by race/ethnicity groups in either the control arm (White: median, 75%; Black: 71%; Hispanic: 75%) or the intervention arm (White: 86%; Black: 88%; Hispanic: 85%).
","[{'ForeName': 'JoAnne E', 'Initials': 'JE', 'LastName': 'Natale', 'Affiliation': 'University of California Davis School of Medicine, 12218, Pediatrics, Sacramento, California, United States; jenatale@ucdavis.edu.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Asaro', 'Affiliation': ""Boston Children's Hospital, Department of Cardiology, Boston, Massachusetts, United States.""}, {'ForeName': 'Jill G', 'Initials': 'JG', 'LastName': 'Joseph', 'Affiliation': 'University of California Davis Betty Irene Moore School of Nursing, 206283, Sacramento, California, United States.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Ulysse', 'Affiliation': 'Massachusetts General Hospital, 2348, Center for Addiction Medicine, Boston, Massachusetts, United States.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Ascenzi', 'Affiliation': ""Johns Hopkins Children's Center, 23235, Anesthesiology and Critical Care Medicine, Baltimore, Maryland, United States.""}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Bowens', 'Affiliation': 'University of Texas Southwestern Medical Center at Dallas, 12334, Dallas, Texas, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wypij', 'Affiliation': ""Boston Children's Hospital, Department of Cardiology, Boston, Massachusetts, United States.""}, {'ForeName': 'Martha A Q', 'Initials': 'MAQ', 'LastName': 'Curley', 'Affiliation': 'University of Pennsylvania, School of Nursing, Philadelphia, Pennsylvania, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201912-872OC']
2138,32776861,Affective responses to high-intensity interval training with continuous and respite music.,"Music has been shown to enhance affective responses to continuous exercise, but the most effective application of music during interval exercise is poorly understood. This study examined two contrasting applications of music designed to assuage the decline in pleasure often experienced during high-intensity interval training (HIIT). In a repeated measures crossover design, 18 recreationally active participants (10 men and 8 women;  M   age  = 25.1 ± 5.1 years;  M   BMI  = 23.08 ± 2.01 kg/m 2;  M  VO 2max  = 38.82 ± 10.73 ml/kg/min) completed three HIIT sessions (10 x 60 s efforts at 100% Wmax, separated by 75 s recovery) on a cycle ergometer. Participants completed two experimental conditions: respite music (applied only during the recovery periods), continuous music (applied throughout the entire HIIT session); and a no-music control condition. Results indicated that music did not influence affective valence during the work bouts or recovery periods of the HIIT sessions ( p s >.05), but that listening to music continuously elicited greater post-task enjoyment ( p  =.032,  d  = 0.66) and remembered pleasure ( p  =.044,  d  = 0.5). This study is the first to investigate the application of music during a practical HIIT protocol and to compare the effects of respite versus continuous music during interval exercise.",2020,"Results indicated that music did not influence affective valence during the work bouts or recovery periods of the HIIT sessions ( p s >.05), but that listening to music continuously elicited greater post-task enjoyment ( p  =.032,  d  = 0.66) and remembered pleasure ( p  =.044,  d  = 0.5).",['18 recreationally active participants (10 men and 8 women;  M   age \xa0=\xa025.1\xa0±\xa05.1\xa0years;  M   BMI \xa0=\xa023.08\xa0±\xa02.01 kg/m 2;  M  VO 2max \xa0=\xa038.82\xa0±\xa010.73'],"['respite music (applied only during the recovery periods), continuous music (applied throughout the entire HIIT session); and a no-music control condition', 'respite versus continuous music during interval exercise', 'HIIT sessions ', 'high-intensity interval training with continuous and respite music']","['remembered pleasure', 'affective valence', 'listening to music continuously elicited greater post-task enjoyment', 'Affective responses']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",,0.0607468,"Results indicated that music did not influence affective valence during the work bouts or recovery periods of the HIIT sessions ( p s >.05), but that listening to music continuously elicited greater post-task enjoyment ( p  =.032,  d  = 0.66) and remembered pleasure ( p  =.044,  d  = 0.5).","[{'ForeName': 'Leighton', 'Initials': 'L', 'LastName': 'Jones', 'Affiliation': 'Department of Sport and Physical Activity, Sheffield Hallam University , Sheffield, UK.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Stork', 'Affiliation': 'School of Health and Exercise Sciences, The University of British Columbia , Kelowna, Canada.'}, {'ForeName': 'Liam S', 'Initials': 'LS', 'LastName': 'Oliver', 'Affiliation': 'School of Exercise and Nutrition Sciences, Queensland University of Technology , Brisbane, Australia.'}]",Journal of sports sciences,['10.1080/02640414.2020.1801324']
2139,32776907,Efficacy of supplemented Er-xian decoction combined with acupoint application for poor ovarian response.,"This study aims to observe the efficacy of supplemented Er-xian decoction combined with acupoint application in treating poor ovarian response (POR). This study was a randomized controlled trial. A total of 80 patients, who were treated in the Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine from January 2016 to December 2017, were divided into two groups by tables of random numbers: experimental group (n = 40), and control group (n = 40). In the experimental group, patients orally received supplemented Er-xian decoction with acupoint application. In the control group, a Kuntai capsule was administered according to the course of treatment. The therapeutic effects in the two groups were observed and compared. In the experimental group, the total effective rate was 90%, the cure rate was 15% (six patients), the markedly effective rate was 35% (14 patients), the effective rate was 40% (16 patients), and the ineffective rate was 10% (four patients). In the control group, the total effective rate was 50%, the cure rate was 5% (two patients), the markedly effective rate was 15% (six patients), the effective rate was 30% (12 patients), and the ineffective rate was 50% (20 patients). The differences were statistically significant (P > 0.05). Definite efficacy was observed when a poor ovarian response was treated by supplemented Er-xian decoction combined with acupoint application. Improvements in perimenopausal symptoms, menstruation conditions, hormone levels, inhibin B (INHB), and antral follicle count (AFC) were markedly better in the experimental group than in the control group. In addition, the treatment was safe and had few side effects.",2020,"In the experimental group, the total effective rate was 90%, the cure rate was 15% (six patients), the markedly effective rate was 35% (14 patients), the effective rate was 40% (16 patients), and the ineffective rate was 10% (four patients).","['A total of 80 patients, who were treated in the Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine from January 2016 to December 2017', 'poor ovarian response']","['supplemented Er-xian decoction combined with acupoint application', 'supplemented Er-xian decoction with acupoint application']","['cure rate', 'ineffective rate', 'total effective rate', 'poor ovarian response (POR', 'perimenopausal symptoms, menstruation conditions, hormone levels, inhibin B (INHB), and antral follicle count (AFC', 'Definite efficacy', 'markedly effective rate', 'effective rate', 'therapeutic effects']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1870428', 'cui_str': 'er-xian decoction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0949062', 'cui_str': 'Perimenopausal symptoms'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0971174', 'cui_str': 'Inhibin B'}, {'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",80.0,0.0191309,"In the experimental group, the total effective rate was 90%, the cure rate was 15% (six patients), the markedly effective rate was 35% (14 patients), the effective rate was 40% (16 patients), and the ineffective rate was 10% (four patients).","[{'ForeName': 'G-L', 'Initials': 'GL', 'LastName': 'Jiang', 'Affiliation': 'Department of Gynecology, Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Nanchang, China.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Wan', 'Affiliation': 'Department of Gynecology, Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Nanchang, China. TCM_wan@163.com.'}, {'ForeName': 'X-Q', 'Initials': 'XQ', 'LastName': 'An', 'Affiliation': 'Department of Gynecology, Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Nanchang, China.'}, {'ForeName': 'W-T', 'Initials': 'WT', 'LastName': 'Yu', 'Affiliation': 'Department of Gynecology, Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Nanchang, China.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Gynecology, Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Nanchang, China.'}, {'ForeName': 'X-M', 'Initials': 'XM', 'LastName': 'Zhou', 'Affiliation': 'Department of Traditional Chinese Medicine, the First Affiliated Hospital of Nanchang University, Nanchang, China.'}]",Journal of physiology and pharmacology : an official journal of the Polish Physiological Society,['10.26402/jpp.2020.2.09']
2140,32776933,"High endemicity of Clonorchis sinensis infection in Binyang County, southern China.","High-intensity clonorchiasis infection is associated with serious outcomes, including cancer. Understanding the infection intensity of Clonorchis sinensis and its risk factors in local endemic regions could facilitate effective control measures. In a county located in a highly endemic area in Guangxi Province, P. R. China, local residents were randomly enrolled in the study; helminth egg examinations were performed with the Kato-Katz method, and the intensity of infection was identified as mild, moderate or heavy. Knowledge, attitudes, and high-risk behaviours were investigated among those infected with Clonorchis sinensis. A total of 2521 local residents participated in this study, and the Clonorchis sinensis-positive proportion was 28.9% (728 persons). Among the infected persons, the percentages of mild, moderate and heavy infections were 66.2%, 28.4% and 5.4%, respectively. Males experienced a higher proportion of moderate and heavy infections (37.5%) than females (18.1%) (p<0.05). The highest infection proportion among the different levels of infection intensity was identified among persons aged 30-59 years (15.7% for moderate and heavy infections). Among the 509 persons who reported eating raw fish, 302 persons (59.3%) had eaten raw fresh fish for more than 10 years, and 131 (25.7%) persons ate raw fish ≥12 times a year. Multivariate logistic regression revealed that eating raw fish 12-50 times in the last year (adjusted odds ratio [aOR] = 1.74, 95%CI: 1.09-2.80) and eating raw fish >50 times in the last year (aOR = 2.89, 95%CI: 1.20-7.50) were risk factors for high-intensity infections (moderate and heavy). The overall infection proportion was high in the study area, with a large group of residents experiencing high-intensity infections. High frequency of raw fish consumption was associated with high-intensity infections. Intervention strategies targeting people with a high frequency of raw fish consumption should be implemented to reduce the probability of severe consequences.",2020,"Among the 509 persons who reported eating raw fish, 302 persons (59.3%) had eaten raw fresh fish for more than 10 years, and 131 (25.7%) persons ate raw fish ≥12 times a year.","['High endemicity of Clonorchis sinensis infection in Binyang County, southern China', '2521 local residents participated in this study, and the Clonorchis sinensis-positive proportion was 28.9% (728 persons', 'In a county located in a highly endemic area in Guangxi Province, P. R. China, local residents were randomly enrolled in the study; helminth egg examinations', '509 persons who reported eating raw fish, 302 persons (59.3%) had eaten raw fresh fish for more than 10 years, and 131 (25.7%) persons ate raw fish ≥12 times a year']",[],"['infection intensity', 'Knowledge, attitudes, and high-risk behaviours', 'percentages of mild, moderate and heavy infections', 'High frequency of raw fish consumption', 'overall infection proportion', 'moderate and heavy infections']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009021', 'cui_str': 'Clonorchiasis'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009022', 'cui_str': 'Clonorchis sinensis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0018893', 'cui_str': 'Helminth'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",[],"[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",2521.0,0.0339929,"Among the 509 persons who reported eating raw fish, 302 persons (59.3%) had eaten raw fresh fish for more than 10 years, and 131 (25.7%) persons ate raw fish ≥12 times a year.","[{'ForeName': 'Junling', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Division of Infectious Disease, Key Laboratory of Surveillance and Early Warning on Infectious Disease, Chinese Centre for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Hualei', 'Initials': 'H', 'LastName': 'Xin', 'Affiliation': 'Division of Infectious Disease, Key Laboratory of Surveillance and Early Warning on Infectious Disease, Chinese Centre for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Zhihua', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Guangxi Centre for Disease Control and Prevention, Nanning, China.'}, {'ForeName': 'Menbao', 'Initials': 'M', 'LastName': 'Qian', 'Affiliation': 'National Institute of Parasitic Diseases, Chinese Centre for Disease Control and Prevention; WHO Collaborative Centre for Malaria, Schistosomiasis and Filariasis; Key Laboratory of Parasite and Vector Biology, Ministry of Health, Shanghai, China.'}, {'ForeName': 'Kaixia', 'Initials': 'K', 'LastName': 'Duan', 'Affiliation': 'Malaria Control Department, Yunnan Institute of Parasitic Diseases, Yunnan, China.'}, {'ForeName': 'Yingdan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'National Institute of Parasitic Diseases, Chinese Centre for Disease Control and Prevention; WHO Collaborative Centre for Malaria, Schistosomiasis and Filariasis; Key Laboratory of Parasite and Vector Biology, Ministry of Health, Shanghai, China.'}, {'ForeName': 'Shizhu', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'National Institute of Parasitic Diseases, Chinese Centre for Disease Control and Prevention; WHO Collaborative Centre for Malaria, Schistosomiasis and Filariasis; Key Laboratory of Parasite and Vector Biology, Ministry of Health, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Parasite Disease Control Department, Binyang Centre for Disease Control and Prevention, Nanning, China.'}, {'ForeName': 'Shiyong', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Director, Binyang Centre for Disease Control and Prevention, Nanning, China.'}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Gan', 'Affiliation': 'Deputy Director, Binyang Centre for Disease Control and Prevention, Nanning, China.'}, {'ForeName': 'Yichao', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Guangxi Centre for Disease Control and Prevention, Nanning, China.'}, {'ForeName': 'Zhongjie', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Division of Infectious Disease, Key Laboratory of Surveillance and Early Warning on Infectious Disease, Chinese Centre for Disease Control and Prevention, Beijing, China.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008540']
2141,32782832,Comparative evaluation of bilateral pudendal nerve blockade and periprostatic nerve block in transrectal ultrasound guided prostate biopsy: a prospective randomised trial.,"Introduction


Although the periprostatic nerve block (PNB) is accepted as the standard method for local anesthesia prior to transrectal ultrasound (TRUS)-guided prostate biopsy, it is not the most ideal method. We aimed to analyze the effectiveness and safety of bilateral pudendal nerve blockage (PuNB) by comparing with PNB.
Material and methods


Between June 2019 and October 2019, a total of 108 patients with elevated serum prostate specific antigen values (PSA ≥4 ng/ml) and/or abnormal digital rectal examination findings were included in the study. After exclusion criteria, the remaining 91 patients were randomly divided into two groups as PuNB (n = 46) and PNB (n = 45). Pain during local anesthesia application was recorded as a visual analog scale (VAS) 1, pain during placement of the rectal probe and manipulation was recorded as VAS 2 and pain during needle penetration into prostate tissue and sampling was recorded as VAS 3.
Results


No significant difference was found between the two groups with regard to age, body mass index, serum PSA, prostate volume and prostate cancer rates. Mean VAS-2 score was significantly lower in the PuNB group when compared with the PNB group. There was no significant difference in terms of VAS-1 and VAS-3 scores. There was no significant difference between the groups in terms of mild and severe complications.
Conclusions


Both techniques are safe for TRUS-guided prostate biopsy; however, PuNB provided more effective pain control compared to PNB especially during placement of rectal probe and manipulation.",2020,"No significant difference was found between the two groups with regard to age, body mass index, serum PSA, prostate volume and prostate cancer rates.","['Material and methods\n\n\nBetween June 2019 and October 2019, a total of 108 patients with elevated serum prostate specific antigen values (PSA ≥4 ng/ml']","['periprostatic nerve block (PNB', 'bilateral pudendal nerve blockade and periprostatic nerve block', 'bilateral pudendal nerve blockage (PuNB', 'transrectal ultrasound guided prostate biopsy', 'PuNB']","['visual analog scale (VAS) 1, pain', 'body mass index, serum PSA, prostate volume and prostate cancer rates', 'Pain', 'VAS-1 and VAS-3 scores', 'Mean VAS-2 score', 'mild and severe complications']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0228959', 'cui_str': 'Structure of pudendal nerve'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0194804', 'cui_str': 'Biopsy of prostate'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",108.0,0.0241391,"No significant difference was found between the two groups with regard to age, body mass index, serum PSA, prostate volume and prostate cancer rates.","[{'ForeName': 'Rahmi', 'Initials': 'R', 'LastName': 'Aslan', 'Affiliation': 'Department of Urology, Yuzuncu Yil University Medical Faculty, Van, Turkey.'}, {'ForeName': 'Akif', 'Initials': 'A', 'LastName': 'Erbin', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Recep', 'Initials': 'R', 'LastName': 'Eryilmaz', 'Affiliation': 'Department of Urology, Yuzuncu Yil University Medical Faculty, Van, Turkey.'}, {'ForeName': 'Kerem', 'Initials': 'K', 'LastName': 'Taken', 'Affiliation': 'Department of Urology, Yuzuncu Yil University Medical Faculty, Van, Turkey.'}]",Central European journal of urology,['10.5173/ceju.2020.0075']
2142,32782892,Engaging Pharmacy Students in Interactive Life-Based Situations as the Basis for Teaching a Biochemistry Course.,"Objectives Undergraduate pharmacy students have neither sufficient training on analyzing the role of biochemistry in actual-life situations nor on its effect on both health and disease. Therefore, we conducted this study to link the biochemistry course with actual-life situations and to encourage students to search for biochemistry answers for the health problems they face. Methods Students were randomized into different groups of three to five students. Every week, a group was asked to search the Internet for the most prevalent disease in their area associated with the biochemistry title studied. The group was asked to have an open discussion was their colleagues about a hot topic in life that is related to this subject. Finally, the group was asked to dig into social media for a current event that grabbed their attention in relation to this subject and write a short paragraph beyond the details. This scenario was repeated weekly using different student groups. The students' opinion was collected before the conduction of the course and the end of the semester. Results The post-course questionnaire showed good improvement in the students' ability to communicate effectively, conduct independent work, participate in active discussion, and solve problems. Overall, the students' satisfaction was significantly elevated. Conclusions We have promoted a method to engage undergraduate students in linking biochemistry theories with real-life situations instead of just memorizing them. The new method improves the students' perception of biochemistry courses. Finally, it provides a promise of a new active learning strategy for undergraduate pharmacy students, which can be used widely to motivate students.",2020,"The post-course questionnaire showed good improvement in the students' ability to communicate effectively, conduct independent work, participate in active discussion, and solve problems.","['undergraduate pharmacy students', 'Objectives Undergraduate pharmacy students']",[],[],"[{'cui': 'C0038497', 'cui_str': 'Pharmacy Student'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",[],[],,0.0211814,"The post-course questionnaire showed good improvement in the students' ability to communicate effectively, conduct independent work, participate in active discussion, and solve problems.","[{'ForeName': 'Mohammed M', 'Initials': 'MM', 'LastName': 'Al-Gayyar', 'Affiliation': 'Biochemistry, Mansoura University, Faculty of Pharmacy, Mansoura, EGY.'}]",Cureus,['10.7759/cureus.9562']
2143,32776828,Testosterone supplementation up-regulates androgen receptor expression and translational capacity during severe energy deficit.,"Testosterone supplementation during energy deficit promotes whole-body lean mass accretion, but the mechanisms underlying that effect remain unclear. To elucidate those mechanisms, skeletal muscle molecular adaptations were assessed from muscle biopsies collected before (Resting), 1 h (Post) and 6 h (Recovery) after exercise and a mixed meal (40 g protein, 1 h post-exercise) following 14 days of weight maintenance (WM) and 28 days of an exercise- and diet-induced 55% energy deficit (ED) in 50 physically active, non-obese men treated with 200 mg testosterone enanthate/week (TEST) or placebo (PLA) during the ED. Participants (n=10/group) exhibiting substantial increases (TEST) in leg lean mass and total testosterone were compared to those exhibiting decreases in both of these measures (PLA). Resting androgen receptor (AR) protein content was higher and fibroblast growth factor-inducible 14 (Fn14), IL-6 receptor (IL-6R), and muscle ring-finger protein-1 (MuRF1) gene expression were lower in TEST versus PLA during ED relative to WM (P < 0.05). Changes in inflammatory, myogenic, and proteolytic gene expression did not differ between groups after exercise and recovery feeding. Mechanistic target of rapamycin (mTOR) signaling (i.e., translational efficiency) was also similar between groups at rest and after exercise and the mixed meal. Muscle total RNA content (i.e., translational capacity) increased more during ED in TEST than PLA (P < 0.05). These findings indicate that attenuated proteolysis at rest, possibly downstream of AR, Fn14, and IL-6R signaling, and increased translational capacity, not efficiency, may drive lean mass accretion with testosterone administration during energy deficit.",2020,"Muscle total RNA content (i.e., translational capacity) increased more during ED in TEST than PLA (P < 0.05).",[],"['Testosterone supplementation', 'rapamycin', '200 mg testosterone enanthate/week (TEST) or placebo (PLA', 'exercise- and diet-induced 55% energy deficit (ED']","['Changes in inflammatory, myogenic, and proteolytic gene expression', 'Muscle total RNA content (i.e., translational capacity', 'Resting androgen receptor (AR) protein content', 'mTOR) signaling (i.e., translational efficiency', 'IL-6 receptor (IL-6R), and muscle ring-finger protein-1 (MuRF1) gene expression']",[],"[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0076189', 'cui_str': 'Testosterone enanthate'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0597304', 'cui_str': 'Protein Degradation'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C1699800', 'cui_str': 'IL6R protein, human'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}]",50.0,0.0901914,"Muscle total RNA content (i.e., translational capacity) increased more during ED in TEST than PLA (P < 0.05).","[{'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Howard', 'Affiliation': 'U.S. Army Research Institute of Environmental Medicine, United States.'}, {'ForeName': 'Lee Mitchell', 'Initials': 'LM', 'LastName': 'Margolis', 'Affiliation': 'U.S. Army Research Institute of Environmental Medicine.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Berryman', 'Affiliation': 'Florida State University, United States.'}, {'ForeName': 'Harris R', 'Initials': 'HR', 'LastName': 'Lieberman', 'Affiliation': 'Military Nutrition Division, U.S. Army Research Institute of Environmental Medicine.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Karl', 'Affiliation': 'Military Nutrition Division, U.S. Army Research Institute of Environmental Medicine, United States.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Young', 'Affiliation': 'U.S. Army Research Institute of Environmental Medicine.'}, {'ForeName': 'Monty A', 'Initials': 'MA', 'LastName': 'Montano', 'Affiliation': 'Harvard Medical School, United States.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Evans', 'Affiliation': 'University of California, Berkeley, United States.'}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Rodriguez', 'Affiliation': 'College of Agriculture, Health and Natural Resources, University of Connecticut, United States.'}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Johannsen', 'Affiliation': 'School of Kinesiology, Louisiana State University, United States.'}, {'ForeName': 'Kishore M', 'Initials': 'KM', 'LastName': 'Gadde', 'Affiliation': 'Pennington Biomedical Research Center, United States.'}, {'ForeName': 'Melissa N', 'Initials': 'MN', 'LastName': 'Harris', 'Affiliation': 'Pennington Biomedical Research Center, United States.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Rood', 'Affiliation': 'Pennington Biomedical Research Center, United States.'}, {'ForeName': 'Stefan M', 'Initials': 'SM', 'LastName': 'Pasiakos', 'Affiliation': 'Military Nutrition Division, U.S. Army Research Institute of Environmental Medicine, United States.'}]",American journal of physiology. Endocrinology and metabolism,['10.1152/ajpendo.00157.2020']
2144,32777055,"Cyclic alternating pattern (CAP) in children with obstructive sleep apnea and its relationship with adenotonsillectomy, behavior, cognition, and quality-of-life.","STUDY OBJECTIVES


To determine in children with obstructive sleep apnea (OSA) the effect of adenotonsillectomy on the cyclic alternating pattern (CAP) and the relationship between CAP and behavioral, cognitive, and quality-of-life measures.
METHODS


CAP parameters were analyzed in 365 overnight polysomnographic recordings of children with mild-to-moderate OSA enrolled in the Childhood Adenotonsillectomy Trial (CHAT), randomized to either early adenotonsillectomy (eAT) or watchful waiting with supportive care (WWSC). We also analyzed CAP in a subgroup of 72 children with moderate OSA (apnea-hypopnea index>10) that were part of the CHAT sample. Causal mediation analysis was performed to determine the independent effect of changes in CAP on selected outcome measures.
RESULTS


At baseline, a higher number of A1-phases per hour of sleep was significantly associated with worse behavioral functioning (caregiver BRIEF GCE: ρ=0.24, P=0.042; caregiver Conners' Rating Scale Global Index: ρ=0.25, P=0.036) and lower quality of life (OSA-18: ρ=0.27, P=0.022; PedsQL: ρ=-0.29, P=0.015) in the subgroup of children with moderate OSA, but not across the entire sample. At 7-months follow-up, changes in CAP parameters were comparable between the eAT and WWSC arms. CAP changes did not account for significant proportions of variations in behavioral, cognitive and quality-of-life performance measures at follow-up.
CONCLUSIONS


We show a significant association between the frequency of slow, high-amplitude waves with behavioral functioning as well as the quality-of-life in children with moderate OSA. Early adenotonsillectomy in children with mild-to-moderate OSA does not alter the microstructure of NREM sleep compared to watchful waiting after an approximately 7 month period of follow-up.
CLINICAL TRIAL


The study ""A Randomized Controlled Study of Adenotonsillectomy for Children With Obstructive Sleep Apnea Syndrome"" was registered at Clinicaltrials.gov (#NCT00560859).",2020,"CAP changes did not account for significant proportions of variations in behavioral, cognitive and quality-of-life performance measures at follow-up.
","['children with mild-to-moderate OSA', '72 children with moderate OSA (apnea-hypopnea index>10) that were part of the CHAT sample', '365 overnight polysomnographic recordings of children with mild-to-moderate OSA enrolled in the Childhood Adenotonsillectomy Trial (CHAT', 'children with obstructive sleep apnea', 'Children', 'children with moderate OSA', 'children with obstructive sleep apnea (OSA']","['Adenotonsillectomy', 'early adenotonsillectomy (eAT) or watchful waiting with supportive care (WWSC', 'adenotonsillectomy', 'Cyclic alternating pattern (CAP']","['CAP parameters', 'lower quality of life', 'quality-of-life', 'behavioral, cognitive and quality-of-life performance measures', 'CAP and behavioral, cognitive, and quality-of-life measures', 'higher number of A1-phases per hour of sleep', ""caregiver Conners' Rating Scale Global Index""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0564385', 'cui_str': '/hour'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",72.0,0.0678171,"CAP changes did not account for significant proportions of variations in behavioral, cognitive and quality-of-life performance measures at follow-up.
","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hartmann', 'Affiliation': 'The University of Adelaide, School of Electrical and Electronic Engineering, Adelaide, Australia.'}, {'ForeName': 'Oliviero', 'Initials': 'O', 'LastName': 'Bruni', 'Affiliation': 'Department of Social and Developmental Psychology, Sapienza University, Rome, Italy.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Ferri', 'Affiliation': 'Sleep Research Center, Department of Neurology IC, Oasi Research Institute - IRCCS, Troina, Italy.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Redline', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital and Beth Israel Deaconess Medical School, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Baumert', 'Affiliation': 'The University of Adelaide, School of Electrical and Electronic Engineering, Adelaide, Australia.'}]",Sleep,['10.1093/sleep/zsaa145']
2145,32777104,Adverse effects of high-dose vitamin D supplementation on volumetric bone density are greater in females than males.,"Three years of high-dose vitamin D supplementation (400, 4000, 10,000 IU) in healthy vitamin D-sufficient individuals aged 55-70 years (serum 25(OH)D 30-125 nmol/L at baseline), resulted in a negative dose-response relationship for bone density and strength. This study examined whether response differed between males and females. 311 participants (53% male) were randomized to 400 (M=61, F=48), 4000 (M=51, F=49), or 10,000 (M=53, F=49) IU daily vitamin D 3  . Participants were scanned on high-resolution peripheral quantitative computed tomography (HR-pQCT) to measure total volumetric BMD (TtBMD) at baseline, 6, 12, 24 and 36 months. Finite element analysis estimated bone strength. Balance, physical function, and clinical biochemistry parameters were also assessed. Constrained linear mixed effects models determined time-by-treatment group-by-sex interactions. Baseline, three-month, and three-year levels of 25(OH)D were 76.3, 76.7, and 77.4 nmol/L (400); 81.3, 115.3, and 132.2 (4000); and 78.4, 188.0, and 144.4 (10,000). There were significant time-by-treatment group-by-sex interactions for TtBMD at the radius (p=0.002) and tibia (p=0.005). Treatment with 4000 or 10,000 compared to 400 IU resulted in TtBMD losses in females, but this was not observed with males. After three years, females lost 1.8% (400), 3.8% (4000) and 5.5% (10,000), whereas males lost 0.9% (400), 1.3% (4000) and 1.9% (10,000) at the radius. At the tibia, losses in TtBMD were smaller, but followed a similar trend. There were no significant bone strength interactions. Vitamin D supplementation with 4000 or 10,000 IU, compared with 400 IU daily, resulted in greater losses of TtBMD over three years in healthy vitamin D-sufficient females, but not males. These results are clinically relevant, as vitamin D supplementation is widely administered to postmenopausal females for osteoporosis prevention. Our findings do not support a benefit of high-dose vitamin D supplementation for bone health, and raise the possibility of harm for females. This article is protected by copyright. All rights reserved.",2020,"Vitamin D supplementation with 4000 or 10,000 IU, compared with 400 IU daily, resulted in greater losses of TtBMD over three years in healthy vitamin D-sufficient females, but not males.","['311 participants (53% male', '400, 4000, 10,000 IU) in healthy vitamin D-sufficient individuals aged 55-70\u2009years (serum 25(OH)D 30-125 nmol/L at baseline), resulted in a negative dose-response relationship for bone density and strength', 'females than males', 'postmenopausal females for osteoporosis prevention', 'males and females']","['vitamin D supplementation', 'Vitamin D supplementation']","['TtBMD losses', 'volumetric bone density', 'bone strength interactions', 'losses of TtBMD', 'Balance, physical function, and clinical biochemistry parameters', 'total volumetric BMD (TtBMD']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3842327', 'cui_str': '4000'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0439282', 'cui_str': 'nmol/L'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C3650929', 'cui_str': 'Prevention of osteoporosis'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.222451,"Vitamin D supplementation with 4000 or 10,000 IU, compared with 400 IU daily, resulted in greater losses of TtBMD over three years in healthy vitamin D-sufficient females, but not males.","[{'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Burt', 'Affiliation': 'McCaig Institute for Bone and Joint Health, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Emma O', 'Initials': 'EO', 'LastName': 'Billington', 'Affiliation': 'McCaig Institute for Bone and Joint Health, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Marianne S', 'Initials': 'MS', 'LastName': 'Rose', 'Affiliation': 'Research Facilitation, Alberta, Health Services, Calgary, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kremer', 'Affiliation': 'Department of Medicine, Division of Endocrinology and Metabolism, McGill University and McGill University Health Center, Montreal, Quebec, Canada.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Hanley', 'Affiliation': 'McCaig Institute for Bone and Joint Health, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Boyd', 'Affiliation': 'McCaig Institute for Bone and Joint Health, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4152']
2146,32777139,Will GRECCAR 2 be a Game Changer for the Management of Rectal Cancer?,"We read with interest the 5-year oncological outcomes for GRECCAR 2, including local recurrence, metastatic disease, and survival.  1  GRECCAR 2 is the first multicentre, randomised trial to compare local excision with total mesorectal excision (TME) in downstaged low rectal cancer. The oncological outcomes are comparable in both arms, suggesting that patients with cT2cT3 tumours can be offered local excision instead of TME surgery. This has major implications in the way we consent patients with rectal cancer. More importantly, could this be a game changer in rectal cancer management?",2020,"1  GRECCAR 2 is the first multicentre, randomised trial to compare local excision with total mesorectal excision (TME) in downstaged low rectal cancer.","['consent patients with rectal cancer', 'downstaged low rectal cancer']",['local excision with total mesorectal excision (TME'],"['local recurrence, metastatic disease, and survival']","[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0278259', 'cui_str': 'Local excision'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0903085,"1  GRECCAR 2 is the first multicentre, randomised trial to compare local excision with total mesorectal excision (TME) in downstaged low rectal cancer.","[{'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Sun Myint', 'Affiliation': 'The Clatterbridge Cancer Centre, Liverpool, UK.'}, {'ForeName': 'Amandeep', 'Initials': 'A', 'LastName': 'Dhadda', 'Affiliation': ""Queen's Centre for Oncology and Haematology, Hull, UK.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Rao', 'Affiliation': 'University Hospital, Imperial College, London, UK.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Sripadam', 'Affiliation': 'The Clatterbridge Cancer Centre, Liverpool, UK.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Pierre Gerard', 'Affiliation': 'Service de Radiothérapie, Centre Antoine-Lacassagne, Nice, France.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.15304']
2147,32777142,L-carnitine supplementation versus cycle ergometer exercise for physical activity and muscle status in hemodialysis patients: A randomized clinical trial.,"Serum carnitine is decreased in hemodialysis patients, which induces muscle atrophy. Thus, we examined the different effects of L-carnitine and exercise on exercise activity and muscle status in hemodialysis patients. Twenty patients were divided into L-carnitine and cycle ergometer groups and were followed for 3 months. Muscle and fat mass, physical activities, and muscle status were evaluated by an impedance, physical function test, and magnetic resonance imaging, respectively. The L-carnitine significantly increased muscle mass (p = .023) and thigh circumference (p = .027), decreased fat mass (p = .007), and shortened chair stand-up time (p = .002) and 10-meter walking time (p = .037). The fat fraction was improved by the L-carnitine (p = .047). Compared with the exercise group, L-carnitine improved the changes in 10-meter walk test (p = .026), chair stand-up time (p = .014), and thigh circumference (p = .022). Baseline fibroblast growth factor-21 and myostatin levels predicted the L-carnitine-associated changes in exercise activities. L-carnitine, rather than exercise, improved physical activity and muscle status in hemodialysis patients.",2020,"The L-carnitine significantly increased muscle mass (p = .023) and thigh circumference (p = .027), decreased fat mass (p = .007), and shortened chair stand-up time (p = .002) and 10-meter walking time (p = .037).","['hemodialysis patients', 'Twenty patients were divided into']","['L-carnitine and cycle ergometer', 'L-carnitine supplementation versus cycle ergometer exercise', 'L-carnitine and exercise']","['physical activity and muscle status', 'thigh circumference', 'chair stand-up time', 'exercise activity and muscle status', 'muscle mass', 'fat fraction', '10-meter walk test', 'Muscle and fat mass, physical activities, and muscle status', 'fat mass', 'Serum carnitine', 'Baseline fibroblast growth factor-21 and myostatin levels', '10-meter walking time', 'shortened chair stand-up time']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0444796', 'cui_str': 'Standing up'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0201937', 'cui_str': 'Carnitine measurement, serum'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0538238', 'cui_str': 'GDF8 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}]",20.0,0.0132059,"The L-carnitine significantly increased muscle mass (p = .023) and thigh circumference (p = .027), decreased fat mass (p = .007), and shortened chair stand-up time (p = .002) and 10-meter walking time (p = .037).","[{'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Yano', 'Affiliation': 'Division of Nephrology, Department of Medicine, Kurume University School of Medicine.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Kaida', 'Affiliation': 'Division of Nephrology, Department of Medicine, Kurume University School of Medicine.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Maeda', 'Affiliation': 'Division of Rehabilitation, Kurume University Hospital.'}, {'ForeName': 'Ryuki', 'Initials': 'R', 'LastName': 'Hashida', 'Affiliation': 'Division of Rehabilitation, Kurume University Hospital.'}, {'ForeName': 'Tatsuyuki', 'Initials': 'T', 'LastName': 'Tonan', 'Affiliation': 'Department of Radiology, Kurume University School of Medicine.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Nagata', 'Affiliation': 'Department of Radiology, Kurume University School of Medicine.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Hazama', 'Affiliation': 'Division of Nephrology, Department of Medicine, Kurume University School of Medicine.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Nakayama', 'Affiliation': 'Division of Nephrology, Department of Medicine, Kurume University School of Medicine.'}, {'ForeName': 'Sakuya', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'Division of Nephrology, Department of Medicine, Kurume University School of Medicine.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Kurokawa', 'Affiliation': 'Division of Nephrology, Department of Medicine, Kurume University School of Medicine.'}, {'ForeName': 'Takaomi', 'Initials': 'T', 'LastName': 'Otome', 'Affiliation': 'Division of Nephrology, Department of Medicine, Kurume University School of Medicine.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Shibata', 'Affiliation': 'Division of Nephrology, Department of Medicine, Kurume University School of Medicine.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Tashiro', 'Affiliation': 'Research Institute of Medical Mass Spectrometry, Kurume University School of Medicine.'}, {'ForeName': 'Tatsuyuki', 'Initials': 'T', 'LastName': 'Kakuma', 'Affiliation': 'Biostatistics Center, Kurume University School of Medicine.'}, {'ForeName': 'Hiroo', 'Initials': 'H', 'LastName': 'Matsuse', 'Affiliation': 'Division of Rehabilitation, Kurume University Hospital.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Fukami', 'Affiliation': 'Division of Nephrology, Department of Medicine, Kurume University School of Medicine.'}]","Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy",['10.1111/1744-9987.13576']
2148,32777156,Improving the quality of preclinical simulation training for dental students using a new digital real-time evaluation system.,"BACKGROUND


With the rapid development of technology, traditional dental education has undergone a transition with the active incorporation of digital technology into curricula. DCARER is a recently developed digital real-time evaluation system for the digital assessment of student preclinical simulation practice performance. The system provides supplementary feedback on process analysis in addition to an objective final result. This study evaluated the grading validity of the DCARER system and its effect on dental preclinical practice skills training.
METHODS


Seventy-three residents of Grade 2018, all of whom had completed their 3-year term residencies in standardized and systematic training, were recruited into this study to examine the system's grading validity. All performed crown preparations with the adoption of the DCARER system, which generated both process and final scores. Three experts gave their own grade anonymously according to the final work. The differences between the digital system and the expert scores were analyzed. In addition, 60 dental students in Grade 4 and 10 dental faculty members were randomly divided into traditional and digital groups. The students in the traditional group prepared the tooth with the guidance of supervisors, while the digital group used the DCARER system. After the class, the students' tooth preparations were scored by the same three experts in a blinded manner. The students and faculty members completed two different sets of questionnaires to evaluate the effects of teaching, acceptance, satisfaction, and evaluation accuracy of the digital system and the traditional method.
RESULTS


The grading validity assessment showed no significant difference between the tooth preparation scores given by the DCARER system and the experts (P > 0.05). The unique process scores given by the DCARER system were weakly correlated with the final scores given by both the digital system and the experts. The main characteristics of the 60 students and 10 faculty members were homogeneous at baseline (P > 0.05). The tooth preparations of the traditional group scored significantly lower than those of the digital group (P < 0.01). More students in the digital group (93.3%) believed the judgment to be objective than in the traditional group (73.3%). All students guided by the DCARER system (100%) and 80% of students taught in a traditional manner felt that the assessment reinforced the learning process. Faculty members reported that use of the digital system did not significantly increase their workload and reinforced the learning process for the internship.
CONCLUSION


The results presented here indicate the validity of grading using the digital real-time evaluation system. Students and faculty could benefit from application of the system in tooth preparation practice, which may provide effective clinical interaction training for dental education.",2020,The tooth preparations of the traditional group scored significantly lower than those of the digital group (P < 0.01).,"['60 dental students in Grade 4 and 10 dental faculty members', 'Seventy-three residents of Grade 2018, all of whom had completed their 3-year term residencies in standardized and systematic training', 'dental students']",[],[],"[{'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0015536', 'cui_str': 'Dental Faculties'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],[],,0.0241957,The tooth preparations of the traditional group scored significantly lower than those of the digital group (P < 0.01).,"[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology. #22, Zhongguancun South Avenue, Haidian District, , Beijing, 100081, PR China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology. #22, Zhongguancun South Avenue, Haidian District, , Beijing, 100081, PR China.'}, {'ForeName': 'Zhongning', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology. #22, Zhongguancun South Avenue, Haidian District, , Beijing, 100081, PR China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Qian', 'Affiliation': 'Department of General Dentistry, Peking University School and Hospital of Stomatology. #22, Zhongguancun South Avenue, Haidian District, Beijing, 100081, PR China.'}, {'ForeName': 'Yuhua', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology. #22, Zhongguancun South Avenue, Haidian District, , Beijing, 100081, PR China.'}, {'ForeName': 'Yunsong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology. #22, Zhongguancun South Avenue, Haidian District, , Beijing, 100081, PR China.'}, {'ForeName': 'Yongsheng', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology. #22, Zhongguancun South Avenue, Haidian District, , Beijing, 100081, PR China.'}]",European journal of dental education : official journal of the Association for Dental Education in Europe,['10.1111/eje.12580']
2149,32777605,"The psychological impact of a nurse-led proactive self-care program on independent, non-frail community-dwelling older adults: A randomized controlled trial.","BACKGROUND


Poor mental health is common later in life and is a crucial factor in determining older adults' ability to live independently in the community. Existing nurse-led proactive self-care programs for older adults focus on physical health, since many are living with chronic diseases. Little is known about their effectiveness on the psychological outcomes of independent, non-frail community-dwelling older adults.
AIM


The aim of this study was to examine the impact of a nurse-led proactive self-care program with a health-social partnership model for community-dwelling older adults on depressive symptoms, life satisfaction, and the mental component of health-related quality of life.
DESIGN AND METHODS


This was a single-blinded, randomized controlled trial. Adults aged 60 or over who lived within the service areas and scored ≥ 18 in the Mini-Mental Status Examination were included. Data were collected using questionnaires pre- (T1), post- (T2), and three month after the intervention (T3). The program provided a comprehensive assessment, health and self-management information, and empowerment, and promoted the accessibility of community services by building a health-social partnership network in the community. Generalized Estimating Equation was used to calculate the group, time, and interaction effects. Intention-to-treat was employed as the primary analysis in this study.
RESULTS


Of the 843 potential community-dwelling older adults who were assessed for eligibility, 457 eligible participants were randomized into the intervention (n = 230) or control group (n = 227). Among them, 175 (76.0%) participants in the intervention group and 190 (83.7%) participants in the control group completed data collection at T3, 6 months after T2 at the completion of the program. The results showed a significant time effect between T1 and T2 (Wald χ2 = 25.7, p < .001) and T1 and T3 (Wald χ2 = 7.40, p = .007) in terms of the presence of depressive symptoms.
CONCLUSIONS


Interprofessional care addressing health and social needs improves the depressive symptoms among older adults dwelling in the community.",2020,"The results showed a significant time effect between T1 and T2 (Wald χ2 = 25.7, p < .001) and T1 and T3 (","['older adults', 'non-frail community-dwelling older adults', 'older adults dwelling in the community', 'community-dwelling older adults', 'frail community-dwelling older adults', '457 eligible participants', 'Adults aged 60 or over who lived within the service areas and scored ≥ 18 in the Mini-Mental Status Examination were included', '843 potential community-dwelling older adults who were assessed for eligibility']","['Existing nurse-led proactive self-care programs', 'nurse-led proactive self-care program', 'nurse-led proactive self-care program with a health-social partnership model']","['depressive symptoms, life satisfaction, and the mental component of health-related quality of life', 'depressive symptoms']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",457.0,0.0758161,"The results showed a significant time effect between T1 and T2 (Wald χ2 = 25.7, p < .001) and T1 and T3 (","[{'ForeName': 'Arkers Kwan Ching', 'Initials': 'AKC', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong. Electronic address: Arkers.wong@polyu.edu.hk.'}, {'ForeName': 'Frances Kam Yuet', 'Initials': 'FKY', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong. Electronic address: Frances.wong@polyu.edu.hk.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103724']
2150,32777606,Cognitive performance of patients with opioid use disorder transitioned to extended-release injectable naltrexone from buprenorphine: Post hoc analysis of exploratory results of a phase 3 randomized controlled trial.,"BACKGROUND


Opioid use disorder (OUD) is associated with cognitive dysfunction. Understanding how pharmacotherapy may affect cognition is an important treatment consideration.
METHODS


This was a hybrid residential-outpatient, randomized trial assessing transition regimens (naltrexone/buprenorphine [NTX/BUP] vs placebo-NTX/buprenorphine [PBO-N]/BUP) to extended-release naltrexone (XR-NTX) in patients with OUD seeking BUP discontinuation. Cognition was assessed at baseline, Day 22 (XR-NTX Day 14), and Day 36 (XR-NTX Day 28) using a range of measures (Brief Assessment of Cognition Symbol Coding test, Controlled Oral Word Association Task, Wechsler Memory Scale-III Spatial Span test, Continuous Performance Test, and Test of Attentional Performance). Pre-specified exploratory analyses compared treatment groups. Post hoc analyses were treatment-arm-independent analyses overall and by baseline BUP dose (<8 mg/day [low-dose] or 8 mg/day [higher-dose]).
RESULTS


Baseline cognitive measures were similar between NTX/BUP and PBO-N/BUP groups and between BUP low-dose and higher-dose groups. There were improvements in several cognitive outcomes at Day 22 and Day 36 relative to baseline for the overall population, but no differences between NTX/BUP and PBO-N/BUP treatment groups were observed. Participants entering the study on low-dose BUP showed improvements at Day 36 relative to baseline in 5 of 7 cognitive outcomes; participants entering the study on higher-dose BUP generally did not show improvements in cognitive outcomes.
CONCLUSIONS


Improvements in most cognitive domains were associated with the transition from BUP to XR-NTX, particularly in participants entering the study on low-dose (<8 mg/day) BUP. These improvements may be due to the discontinuation of BUP, the treatment with XR-NTX, or both.",2020,"There were improvements in several cognitive outcomes at Day 22 and Day 36 relative to baseline for the overall population, but no differences between NTX/BUP and PBO-N/BUP treatment groups were observed.","['patients with OUD seeking BUP discontinuation', 'patients with opioid use disorder transitioned to extended-release injectable']","['naltrexone (XR-NTX', 'naltrexone', 'naltrexone/buprenorphine [NTX/BUP', 'buprenorphine', 'placebo-NTX/buprenorphine [PBO-N]/BUP']","['cognitive outcomes', 'range of measures (Brief Assessment of Cognition Symbol Coding test, Controlled Oral Word Association Task, Wechsler Memory Scale-III Spatial Span test, Continuous Performance Test, and Test of Attentional Performance', 'Cognition', 'several cognitive outcomes', 'Cognitive performance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3827022', 'cui_str': 'Controlled Oral Word Association Test'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]",,0.0245195,"There were improvements in several cognitive outcomes at Day 22 and Day 36 relative to baseline for the overall population, but no differences between NTX/BUP and PBO-N/BUP treatment groups were observed.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kosten', 'Affiliation': 'Baylor College of Medicine and MEDVAMC, Houston, TX, United States. Electronic address: kosten@bcm.edu.'}, {'ForeName': 'Efrat', 'Initials': 'E', 'LastName': 'Aharonovich', 'Affiliation': 'Department of Psychiatry, Columbia University Medical Center, and The New York State Psychiatric Institute, New York, NY, United States.'}, {'ForeName': 'Narinder', 'Initials': 'N', 'LastName': 'Nangia', 'Affiliation': 'Alkermes, Inc., Waltham, MA, United States.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Zavod', 'Affiliation': 'Alkermes, Inc., Waltham, MA, United States.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Akerman', 'Affiliation': 'Alkermes, Inc., Waltham, MA, United States.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lopez-Bresnahan', 'Affiliation': 'Alkermes, Inc., Waltham, MA, United States.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Sullivan', 'Affiliation': 'Department of Psychiatry, Columbia University Medical Center, and The New York State Psychiatric Institute, New York, NY, United States; Alkermes, Inc., Waltham, MA, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106538']
2151,32777617,Longitudinal suicide ideation trajectories in a clinical trial of brief CBT for U.S. military personnel recently discharged from psychiatric hospitalization.,"Research among adolescent samples has suggested patterns of change in suicidal ideation (SI) following psychiatric hospitalization discharge are heterogenous and predictive of subsequent suicide attempts. However, no studies have examined SI trajectories following discharge among adult samples or the effect of treatment on trajectories. We used growth mixture modeling to examine trajectories of SI among 152 active duty military personnel in a randomized controlled trial comparing brief cognitive-behavioral therapy (CBT) for suicide prevention to treatment as usual following discharge from inpatient psychiatric hospitalization for a suicide risk. Analyses of SI at baseline, 3-, 6-, and 12-months post-discharge among the full sample randomized to both conditions revealed two trajectories: rapid improvers (59.21%) and gradual improvers (40.79%). Gradual improvers were more than twice as likely to attempt suicide in the two years following discharge. Exploratory analyses suggested that, relative to those in the treatment as usual condition, those randomized to brief CBT in both trajectories may be less likely to make a suicide attempt during the follow-up period. Results replicate and extend prior research in identifying distinct ideation trajectories following psychiatric inpatient hospitalization for suicide risk to active-duty personnel in a treatment trial and linking these trajectories to suicide attempts during follow-up.",2020,Gradual improvers were more than twice as likely to attempt suicide in the two years following discharge.,['152 active duty military personnel'],['cognitive-behavioral therapy (CBT'],['Longitudinal suicide ideation trajectories'],"[{'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0392348', 'cui_str': 'Ideation'}]",152.0,0.135962,Gradual improvers were more than twice as likely to attempt suicide in the two years following discharge.,"[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Lee', 'Affiliation': 'National Center for PTSD, Boston, MA, United States; VA Boston Healthcare System, Boston, MA, United States; Boston University School of Medicine, Boston, MA, United States. Electronic address: daniel.lee14@va.gov.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Bryan', 'Affiliation': 'National Center for Veterans Studies, Salt Lake City, UT, United States; University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'M David', 'Initials': 'MD', 'LastName': 'Rudd', 'Affiliation': 'National Center for Veterans Studies, Salt Lake City, UT, United States; University of Memphis, Memphis, TN, United States.'}]",Psychiatry research,['10.1016/j.psychres.2020.113335']
2152,32777664,Digital application developed to evaluate functional results following robot-assisted radical prostatectomy: App for prostate cancer.,"INTRODUCTION


Mobile applications (""apps"") developed for smartphones and tablets are increasingly used in healthcare, allowing remote patient support or promoting self-health care. Prostate cancer (PC) screening allows for early-stage PC diagnosis, resulting in high rates of curative procedures such as radical prostatectomy. The main complications following surgery are urinary incontinence and erectile dysfunction. However, the exact numbers related to these morbidities are often missing due to brief interviews during consultations in the medical office. Therefore, the aim of this study was to create an app to determine whether response rates to pre- and post-surgical PC questionnaires will increase.
METHODS


The app was built using the IONIC framework system and provided to patients through a prospective randomized study. We included 100 patients divided into two groups: 1. first group used the app (n = 50); and 2. second group responded via validated printed questionnaires (control group) (n = 50). All patients received discharge counseling to respond to the questionnaires 1, 3, 6 and 12 months after the procedure. The app group received verbal guidance on how monitoring would occur, received an SMS containing a username and password providing access to the system and received reminder alerts to respond to the questionnaires.
RESULTS


The new app is called UroHealth and is available for download in the Apple App Store or at www.urohealth.com.br. When we evaluated the response rates, we found that 42.9% of the patients answered the preoperative questionnaire in the app group, while 16% responded in the control group (p = 0.003). By the end of the follow-up, we found that 24.5% of the patients answered the questionnaire in the app group, while 4% responded in the control group (p = 0.003).
CONCLUSION


This app enabled almost 6 times more patients to answer long-term follow-up questions after surgical procedures, providing high-quality information regarding morbidity related to treatment. Although our initial results indicate that this app may become a useful tool in obtaining more frequent and realistic answers, thus helping to improve surgical techniques, other ways of reaching the patient should be tested to achieve higher response rates.",2020,"Prostate cancer (PC) screening allows for early-stage PC diagnosis, resulting in high rates of curative procedures such as radical prostatectomy.",['100 patients divided into two groups: 1. first group used the app (n\xa0=\xa050); and'],"['robot-assisted radical prostatectomy', 'SMS containing a username and password providing access to the system and received reminder alerts to respond to the questionnaires', 'verbal guidance', '2. second group responded via validated printed questionnaires (control group', 'discharge counseling']","['response rates', 'preoperative questionnaire', 'urinary incontinence and erectile dysfunction']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}]",100.0,0.0209113,"Prostate cancer (PC) screening allows for early-stage PC diagnosis, resulting in high rates of curative procedures such as radical prostatectomy.","[{'ForeName': 'Leandro F', 'Initials': 'LF', 'LastName': 'Faria', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: lfaria83@gmail.com.'}, {'ForeName': 'Sabrina T', 'Initials': 'ST', 'LastName': 'Reis', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil; Faculdade Atenas - Campus Passos, Minas Gerais, 37900-380, Brazil. Electronic address: sasareis@gmail.com.'}, {'ForeName': 'Katia R', 'Initials': 'KR', 'LastName': 'Leite', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: katiaramos@usp.br.'}, {'ForeName': 'José Arnaldo Shiomi', 'Initials': 'JAS', 'LastName': 'da Cruz', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: arnadolshiomi@yahoo.com.br.'}, {'ForeName': 'Ruan', 'Initials': 'R', 'LastName': 'Pimenta', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: ruanpimenta22@gmail.com.'}, {'ForeName': 'Nayara I', 'Initials': 'NI', 'LastName': 'Viana', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: nayara_viana_2@hotmail.com.'}, {'ForeName': 'Gabriela Q', 'Initials': 'GQ', 'LastName': 'Amaral', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: gabriela.queiroz.amaral@gmail.com.'}, {'ForeName': 'Gabriel A G D', 'Initials': 'GAGD', 'LastName': 'Santos', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: arantes_gabriel@hotmail.com.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ilias', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: daniel.ilias22@gmail.com.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Fakhouri', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: ffakhouri@gmail.com.'}, {'ForeName': 'Geraldo', 'Initials': 'G', 'LastName': 'Xavier', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: geraldoxaviermed@gmail.com.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Srougi', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: srougi@uol.com.br.'}, {'ForeName': 'Carlo Camargo', 'Initials': 'CC', 'LastName': 'Passerotti', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil; Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: carlopasserotti@hotmail.com.'}]",Computer methods and programs in biomedicine,['10.1016/j.cmpb.2020.105683']
2153,32777692,Health-related quality of life and opioid use disorder pharmacotherapy: A secondary analysis of a clinical trial.,"OBJECTIVE


To examine the health-related quality-of-life (HRQoL) of persons with opioid use disorder (OUD) seeking treatment in an inpatient detoxification or short-term residential setting; continuing treatment as outpatients.
METHODS


We conducted a secondary analysis of data from a clinical trial (N = 508) where participants were randomized to extended-release naltrexone or buprenorphine-naloxone for the prevention of opioid relapse. We used a generalized structural equation regression mixture model to identify associations of HRQoL (EQ-5D) trajectories, including latent characteristics, over the 24-week trial and 36-week follow-up period, among participants who reported HRQoL beyond baseline. This novel framework accounted for baseline and time-varying characteristics, while simultaneously identifying latent classes.
RESULTS


We identified two subpopulations: HRQoL ""pharmacotherapy responsive"" (82.3 %) and HRQoL ""characteristic sensitive"" (17.7 %). The pharmacotherapy responsive subpopulation was characterized by a shortterm HRQoL improvement and then stable HRQoL over time, and by a positive association between HRQoL and receiving pharmacotherapy in the past 30 days. The characteristic sensitive subpopulation was characterized by an initial improvement in HRQoL with a gradual decline over time, and no significant HRQoL response to pharmacotherapy. HRQoL changes over time in this subpopulation were more influenced by baseline demographic, socioeconomic, and psychosocial characteristics.
CONCLUSION


Our findings suggest that while HRQoL may be improved and sustained through targeted efforts to promote use of pharmacotherapy for many persons with OUD, an identifiable subpopulation may require additional services that address socioeconomic and psychosocial issues to achieve HRQoL benefits. Our analysis provides insight for improving individualized care for persons with opioid use disorder seeking treatment.",2020,"We identified two subpopulations: HRQoL ""pharmacotherapy responsive"" (82.3 %) and HRQoL ""characteristic sensitive"" (17.7 %).","['persons with opioid use disorder seeking treatment', 'persons with opioid use disorder (OUD', 'participants who reported HRQoL beyond baseline']","['naltrexone or buprenorphine-naloxone', 'opioid use disorder pharmacotherapy']",['health-related quality-of-life (HRQoL'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",508.0,0.0789426,"We identified two subpopulations: HRQoL ""pharmacotherapy responsive"" (82.3 %) and HRQoL ""characteristic sensitive"" (17.7 %).","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Jalali', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA. Electronic address: alj4004@med.cornell.edu.'}, {'ForeName': 'Danielle A', 'Initials': 'DA', 'LastName': 'Ryan', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Jeng', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'McCollister', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Jared A', 'Initials': 'JA', 'LastName': 'Leff', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Lee', 'Affiliation': 'New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'New York State Psychiatric Institute, Columbia University Medical Center, New York, NY USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Novo', 'Affiliation': 'New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Schackman', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Murphy', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108221']
2154,32778009,Efficacy of psychotherapy for anxiety reduction in hospital management of women successfully treated for preterm labor: a randomized controlled trial.,"Preterm labor (PTL) is associated with high anxiety and stress in pregnant women. The study investigated the effect of adding psychotherapy to hospital management of pregnant women with successfully treated for PTLon improving anxiety, pregnancy stress, and perceived control. In a randomized controlled trial study, sixty pregnant women with gestational ages of 24 to 37 weeks and successfully treated forPTL were randomly divided into the experimental (n = 30) and control group (n = 30). The experimental group received psychotherapy along with medical care in individual face-to-facesessions, 1 h per day for 6 consecutive days.The control group received medical care for PTL. Objective outcomes were assessed via the State-Anxiety Inventory, Prenatal Distress Questionnaire (NuPDQ), and Perceived Pregnancy Control at pre-trial and post-trial. The results revealed that psychotherapy significantly improved mean pregnancy distress (45.80 ± 2.29 vs. 43.80 ± 1.93), state anxiety (47.46 ± 5.92 vs. 41.60 ± 5.46), and perceived control (2.86 ± 1.59 vs. 5.26 ± 1.38) in women with PTL from beginning to end of the intervention. The findings suggest that adding psychotherapy to hospital management of women successfully treated for PTLcan be considered a potential method to reduce anxiety and pregnancy-specific stress.",2020,"The results revealed that psychotherapy significantly improved mean pregnancy distress (45.80 ± 2.29 vs. 43.80 ± 1.93), state anxiety (47.46 ± 5.92 vs. 41.60 ± 5.46), and perceived control (2.86 ± 1.59 vs. 5.26 ± 1.38) in women with PTL from beginning to end of the intervention.","['pregnant women with successfully treated for PTLon improving anxiety, pregnancy stress, and perceived control', 'sixty pregnant women with gestational ages of 24 to 37\xa0weeks and successfully treated forPTL', 'hospital management of women successfully treated for preterm labor', 'pregnant women']","['psychotherapy', 'Preterm labor (PTL', 'medical care for PTL']","['mean pregnancy distress', 'State-Anxiety Inventory, Prenatal Distress Questionnaire (NuPDQ), and Perceived Pregnancy Control', 'state anxiety']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019948', 'cui_str': 'Administration, Hospital'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022876', 'cui_str': 'Premature labor'}]","[{'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0022876', 'cui_str': 'Premature labor'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",60.0,0.125459,"The results revealed that psychotherapy significantly improved mean pregnancy distress (45.80 ± 2.29 vs. 43.80 ± 1.93), state anxiety (47.46 ± 5.92 vs. 41.60 ± 5.46), and perceived control (2.86 ± 1.59 vs. 5.26 ± 1.38) in women with PTL from beginning to end of the intervention.","[{'ForeName': 'Seyyedeh Mahboubeh', 'Initials': 'SM', 'LastName': 'Mirtabar', 'Affiliation': 'Department of Psychology, Islamic Azad University, Ayatollah Amoli Science and Research Branch, Amol, Iran.'}, {'ForeName': 'Mahbobeh', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Social Determinants of Health Research Center, Health Research Institute, Babol University of Medical Sciences , Babol, Iran.'}, {'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Khazaei', 'Affiliation': 'Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Dini', 'Affiliation': 'Clinical Research Development Unit of Rohani Hospital, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}]",Women & health,['10.1080/03630242.2020.1803464']
2155,32778017,"Combination of Low-Dose, Short-Course Mycophenolate Mofetil With Cyclosporine and Methotrexate for Graft-Versus-Host Disease Prophylaxis in Allogeneic Stem Cell Transplant.","OBJECTIVES


With the standard regimen for graft-versushost disease prophylaxis in allogeneic stem cell transplant with human leukocyte antigen-matched donor, grade II-IV acute graft-versus-host disease occurs in 30% to 50% of sibling and up to 80% of unrelated recipients. Studies with limited patient numbers have shown efficacy and safety of mycophenolate mofetil for graft-versus-host disease prophylaxis. We investigated the effect of low-dose mycophenolate mofetil added to a standardized prophylaxis regimen for graft-versus-host disease in related human leukocyte antigen-matched allogeneic stem cell transplant.
MATERIALS AND METHODS


In this prospective randomized clinical trial, we compared cyclosporine and methotrexate versus the combination of cyclosporine, methotrexate, and mycophenolate mofetil in all patients who underwent human leukocyte antigencompatible related donor allogeneic stem cell transplant for acute leukemia during 3 years at the Bone Marrow Transplant Unit at Namazi Hospital, Shiraz University of Medical Sciences (Shiraz, Iran).
RESULTS


All 134 patients in both groups underwent successful engraftment. Recovery times for neutrophils and platelets were not significantly different between groups (P < .05). Incidence of acute graft-versus-host disease in the cyclosporine, methotrexate, and mycophenolate mofetil group was less than in the cyclosporine and methotrexate group (21.6% vs 40.9%; P = .041). Incidence of grade II-IV acute graftversus-host disease in the mycophenolate mofetil group was 15.2% versus the control group at 33% (P = .045).
CONCLUSIONS


Our single-center study suggests the combination of mycophenolate mofetil, cyclosporine, and methotrexate is superior to the standard regimen of cyclosporine and methotrexate for graft-versushost disease prophylaxis after human leukocyte antigen-matched related donor allogeneic stem cell transplant.",2020,Recovery times for neutrophils and platelets were not significantly different between groups (P < .05).,"['graft-versushost disease prophylaxis after human leukocyte antigen-matched related donor allogeneic stem cell transplant', 'graft-versus-host disease in related human leukocyte antigen-matched allogeneic stem cell transplant', 'Allogeneic Stem Cell Transplant', 'all patients who underwent human leukocyte antigencompatible related donor allogeneic stem cell transplant for acute leukemia during 3 years at the Bone Marrow Transplant Unit at Namazi Hospital, Shiraz University of Medical Sciences (Shiraz, Iran']","['Cyclosporine and Methotrexate', 'mycophenolate mofetil', 'Low-Dose, Short-Course Mycophenolate Mofetil', 'mycophenolate mofetil, cyclosporine, and methotrexate', 'cyclosporine, methotrexate, and mycophenolate mofetil', 'cyclosporine and methotrexate']","['Incidence of grade II-IV acute graftversus-host disease', 'Recovery times for neutrophils and platelets', 'Incidence of acute graft-versus-host disease']","[{'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0019629', 'cui_str': 'Class I Histocompatibility Antigens'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0018133', 'cui_str': 'Graft versus host disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005961', 'cui_str': 'Transplantation of bone marrow'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease'}]",134.0,0.0383746,Recovery times for neutrophils and platelets were not significantly different between groups (P < .05).,"[{'ForeName': 'Mani', 'Initials': 'M', 'LastName': 'Ramzi', 'Affiliation': 'From the Hematology Research Center and Bone Marrow Transplantation Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Haghighat', 'Affiliation': ''}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Namdari', 'Affiliation': ''}, {'ForeName': 'Hourvash', 'Initials': 'H', 'LastName': 'Haghighinejad', 'Affiliation': ''}]",Experimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation,['10.6002/ect.2020.0004']
2156,32778059,Study protocol: pragmatic randomized control trial of my tools 4 care- in care (MT4C-in care) a web-based tool for family Carers of persons with dementia residing in long term care.,"BACKGROUND


When a family member resides in long term care facility (LTC), family carers continue caregiving and have been found to have decreases in mental health. The aim of My Tools 4 Care - In Care (an online intervention) is to support carers of persons living with dementia residing in LTC through transitions and increase their self-efficacy, hope, social support and mental health. This article comprises the protocol for a study to evaluate My Tools 4 Care-In Care (MT4C-In Care) by asking the following research questions: 1) Is there a 2 month (immediately post-intervention) and 4 month (2 months post-intervention) increase in mental health, general self-efficacy, social support and hope, and decrease in grief and loneliness, in carers of a person living with dementia residing in LTC using MT4C-In CARE compared to an educational control group? 2) Do carers of persons living with dementia residing in LTC perceive My Tools 4 Care- In Care helps them with the transitions they experience?
METHODS


This study is a single blinded pragmatic mixed methods randomized controlled trial. Approximately 280 family carers of older persons (65 years of age and older) with dementia residing in LTC will be recruited for this study. Data will be collected at three time points: baseline, 2 month, and 4 months. Based on the feasibility study, we hypothesize that participants using MT4C-In Care will report significant increases in hope, general self-efficacy, social support and mental health quality of life, and significant decreases in grief and loneliness from baseline, as compared to an educational control group. To determine differences between groups and over time, generalized estimating equations analysis will be used. Qualitative descriptive analysis will be used to further evaluate MT4C-In Care and if it supports carers through transitions.
DISCUSSION


Data collection will begin in four Canadian provinces (Alberta, Manitoba, Ontario and Saskatchewan) in February 2020 and is expected to be completed in June 2021. The results will inform policy and practice as MT4C-In Care can be revised for local contexts and posted on websites such as those hosted by the Alzheimer Society of Canada.
TRIAL REGISTRATION


NCT04226872 ClinicalTrials.gov Registered 09 January 2020 Protocol Version #2 Feb 19, 2020.",2020,"In Care (an online intervention) is to support carers of persons living with dementia residing in LTC through transitions and increase their self-efficacy, hope, social support and mental health.","['family Carers of persons with dementia residing in long term care', '09 January 2020', 'four Canadian provinces (Alberta, Manitoba, Ontario and Saskatchewan) in February 2020 and is expected to be completed in June 2021', 'Approximately 280 family carers of older persons (65\u2009years of age and older) with dementia residing in LTC', 'persons living with dementia residing in LTC perceive My Tools 4 Care']","['my tools 4 care- in care (MT4C-in care', 'LTC using MT4C-In CARE compared to an educational control group']","['hope, general self-efficacy, social support and mental health quality of life', 'grief and loneliness', 'mental health, general self-efficacy, social support and hope, and decrease in grief and loneliness']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0024726', 'cui_str': 'Manitoba'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0036234', 'cui_str': 'Saskatchewan'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4521843', 'cui_str': 'US Military Commissioned Officer O5'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]","[{'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C4521843', 'cui_str': 'US Military Commissioned Officer O5'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",,0.0704955,"In Care (an online intervention) is to support carers of persons living with dementia residing in LTC through transitions and increase their self-efficacy, hope, social support and mental health.","[{'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Duggleby', 'Affiliation': 'Faculty of Nursing, University of Alberta, Level 3 Edmonton Clinic Health Academy, 11405 87 Avenue, Edmonton, Alberta, T6G 1C9, Canada. wendy.duggleby@ualberta.ca.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': ""O'Rourke"", 'Affiliation': 'Faculty of Nursing, University of Alberta, Level 3 Edmonton Clinic Health Academy, 11405 87 Avenue, Edmonton, Alberta, T6G 1C9, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Swindle', 'Affiliation': 'Faculty of Nursing, University of Alberta, Level 3 Edmonton Clinic Health Academy, 11405 87 Avenue, Edmonton, Alberta, T6G 1C9, Canada.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Peacock', 'Affiliation': 'College of Nursing, University of Saskatchewan, 104 Clinic Place, Saskatoon, SK, S7N 2Z4, Canada.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'McAiney', 'Affiliation': 'Schlegel-UW Research Institute for Aging, School of Public Health and Health Systems, University of Waterloo, 200 University Avenue West, Waterloo, ON, N2L 3G1, Canada.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Baxter', 'Affiliation': 'School of Nursing, McMaster University, 1280 Main St. W, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Thompson', 'Affiliation': 'College of Nursing, Faculty of Health Sciences, University of Manitoba, 89 Curry Place, Winnipeg, MB, R3T 2N2, Canada.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Dubé', 'Affiliation': ""Faculty of Nursing, Université de Montréal Marguerite d'Youville Research, Université de Montréal, PO Box 6128, Centre-ville Station, Montréal, QC, H3C 3J7, Canada.""}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Nekolaichuk', 'Affiliation': 'Department of Oncology, University of Alberta, c/o Palliative Institute, DC 404, 1090 Youville Drive, Edmonton, AB, T6L 0A3, Canada.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Departments of Medical Oncology and Mathematical and Statistical Sciences, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Jayna', 'Initials': 'J', 'LastName': 'Holroyd-Leduc', 'Affiliation': 'Division of Geriatric Medicine, Departments of Medicine and Community Health Sciences, University of Calgary, 1403 - 29th Street NW, Calgary, AB, T2N2T9, Canada.'}]",BMC geriatrics,['10.1186/s12877-020-01690-w']
2157,32778083,Quality and extent of implementation of a nurse-led care management intervention: care coordination for health promotion and activities in Parkinson's disease (CHAPS).,"BACKGROUND


A recent nurse-led, telephone-administered 18-month intervention, Care Coordination for Health Promotion and Activities in Parkinson's Disease (CHAPS), was tested in a randomized controlled trial and improved care quality. Therefore, intervention details on nurse care manager activity (types and frequencies) and participant actions are needed to support potential dissemination. Activities include nurse care manager use of a holistic organizing framework, identification of Parkinson's disease (PD)-related problems/topics, communication with PD specialists and care coordination, participant coaching, and participant self-care actions including use of a notebook self-care tool.
METHODS


This article reports descriptive data on the CHAPS intervention. The study setting was five sites in the Veterans Affairs Healthcare System. Sociodemographic data were gathered from surveys of study participants (community-dwelling veterans with PD). Nurse care manager intervention activities were abstracted from electronic medical records and logbooks. Statistical analysis software was used to provide summary statistics; closed card sorting was used to group some data.
RESULTS


Intervention participants (n = 140) were primarily men, mean age 69.4 years (standard deviation 10.3) and community-dwelling. All received the CHAPS Initial Assessment, which had algorithms designed to identify 31 unique CHAPS standard problems/topics. These were frequently documented (n = 4938), and 98.6% were grouped by assigned domain from the Organizing Framework (Siebens Domain Management Model™). Nurse care managers performed 27 unique activity types to address identified problems, collaborating with participants and PD specialists. The two most frequent unique activities were counseling/emotional support (n = 387) and medication management (n = 349). Both were among 2749 total performed activities in the category Implementing Interventions (coaching). Participants reported unique self-care action types (n = 23) including use of a new notebook self-care tool.
CONCLUSIONS


CHAPS nurse care managers implemented multiple activities including participant coaching and care coordination per the CHAPS protocol. Participants reported various self-care actions including use of a personalized notebook. These findings indicate good quality and extent of implementation, contribute to ensuring reproducibility, and support CHAPS dissemination as a real-world approach to improve care quality.
TRIAL REGISTRATION


ClinicalTrials.gov as NCT01532986 , registered on January 13, 2012.",2020,"Participants reported unique self-care action types (n = 23) including use of a new notebook self-care tool.
","['Intervention participants (n\u2009=\u2009140) were primarily men, mean age 69.4\u2009years (standard deviation 10.3) and community-dwelling', 'Participants reported unique self-care action types (n\u2009=\u200923) including use of a new notebook self-care tool', ""Parkinson's disease (CHAPS"", 'participants (community-dwelling veterans with PD', ""Parkinson's Disease (CHAPS""]",[],[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]",[],[],,0.0125391,"Participants reported unique self-care action types (n = 23) including use of a new notebook self-care tool.
","[{'ForeName': 'Karen I', 'Initials': 'KI', 'LastName': 'Connor', 'Affiliation': ""Veterans Affairs Southwest Parkinson's Disease Research, Education and Clinical Center, Los Angeles, CA, USA. kiconnor@ucla.edu.""}, {'ForeName': 'Hilary C', 'Initials': 'HC', 'LastName': 'Siebens', 'Affiliation': 'Siebens Patient Care Communications LLC, Seal Beach, CA, USA.'}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Mittman', 'Affiliation': 'Kaiser Permanente Research, Pasadena, CA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ganz', 'Affiliation': 'University of California, Los Angeles David Geffen School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Barry', 'Affiliation': 'University of California, Los Angeles David Geffen School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Ernst', 'Affiliation': 'American Association of Nurse Practitioners, Austin, TX, USA.'}, {'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Edwards', 'Affiliation': ""Veterans Affairs Southwest Parkinson's Disease Research, Education and Clinical Center, Los Angeles, CA, USA.""}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'McGowan', 'Affiliation': ""Veterans Affairs Southwest Parkinson's Disease Research, Education and Clinical Center, Los Angeles, CA, USA.""}, {'ForeName': 'Donna K', 'Initials': 'DK', 'LastName': 'McNeese-Smith', 'Affiliation': 'UCLA School of Nursing, Los Angeles, CA, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Cheng', 'Affiliation': 'University of California, Los Angeles David Geffen School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Barbara G', 'Initials': 'BG', 'LastName': 'Vickrey', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}]",BMC health services research,['10.1186/s12913-020-05594-8']
2158,32783351,"Tapering Canakinumab Monotherapy in Patients with Systemic Juvenile Idiopathic Arthritis in Clinical Remission: Results from an Open-label, Randomized Phase IIIb/IV Study.","OBJECTIVE


To evaluate the efficacy and safety of two canakinumab monotherapy tapering regimens to maintain complete clinical remission (CR) in children with systemic juvenile idiopathic arthritis (sJIA).
METHODS


Two-part open-label study. In Part I, patients received 4 mg/kg canakinumab subcutaneously every 4 weeks (q4w) and discontinued glucocorticoids and/or methotrexate as appropriate. Patients who achieved CR (inactive disease for at least 24 weeks) on canakinumab monotherapy entered Part II and were randomized (1:1) to Arm 1 (dose reduction from 4 to 2 to 1 mg/kg and then discontinuation) or Arm 2 (dose interval prolongation from q4w to q8w to q12w and then discontinuation). In both arms, canakinumab exposure could be reduced provided that patients remained in CR for 24 weeks with each step. The primary objective was to assess whether more than 40% of randomized patients in either arm remained in CR for 24 weeks in the first step.
RESULTS


182 patients entered Part I of the study and 75 were randomized and entered Part II. Of the 75 patients, 27/38 (71%) in Arm 1 (2 mg/kg q4w) and 31/37 (84%) in Arm 2 (4 mg/kg q8w) maintained CR for 24 weeks in the first step (P ≤ 0.0001 for each arm vs 40%). Overall, 25/75 (33%) patients discontinued canakinumab and remained in CR for at least 24 weeks. No new safety signals were identified.
CONCLUSION


Reduction of exposure to canakinumab may be feasible in patients with sJIA who achieved CR, but consistent IL-1 inhibition seems necessary to maintain this response.",2020,"No new safety signals were identified.
","['182 patients entered Part I of the study and 75 were randomized and entered Part II', 'Patients who achieved CR (inactive disease for at least 24 weeks) on canakinumab monotherapy entered Part II', 'patients with sJIA', 'Patients with Systemic Juvenile Idiopathic Arthritis in Clinical Remission', 'children with systemic juvenile idiopathic arthritis (sJIA', 'Two-part open-label study']","['glucocorticoids and/or methotrexate', 'canakinumab monotherapy tapering regimens', 'Tapering Canakinumab Monotherapy']",['efficacy and safety'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C1384600', 'cui_str': 'Systemic onset juvenile chronic arthritis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",182.0,0.0414306,"No new safety signals were identified.
","[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Quartier', 'Affiliation': 'RAISE reference centre for rare diseases and pediatric immunology-hematology and rheumatology unit, Necker-Enfants Malades Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Alexeeva', 'Affiliation': ""National Medical Research Center of Children's Health of the Ministry of Health of the Russian Federation, Moscow, Russia.""}, {'ForeName': 'Constantin', 'Initials': 'C', 'LastName': 'Tamàs', 'Affiliation': 'Unit of Pediatric Rheumatology-Immunology, Second Department of Pediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Vyacheslav', 'Initials': 'V', 'LastName': 'Chasnyk', 'Affiliation': 'Saint-Petersburg State Pediatric Medical University, Saint-Petersburg, Russian Federation.'}, {'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Wulffraat', 'Affiliation': 'University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Palmblad', 'Affiliation': 'Karolinska Institutet, Department of Women and Child Health, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Wouters', 'Affiliation': 'Department of Paediatrics, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Hermine', 'Initials': 'H', 'LastName': 'Brunner', 'Affiliation': ""Division of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Marzan', 'Affiliation': ""Department of Pediatrics, Division of Rheumatology, Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Rayfel', 'Initials': 'R', 'LastName': 'Schneider', 'Affiliation': 'Pediatric Rheumatology, The University of Toronto and Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Horneff', 'Affiliation': 'Department of General Paediatrics, Asklepios Klinik Sankt Augustin, Sankt Augustin, Germany.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Martini', 'Affiliation': 'Direzione Scientifica, IRCCS Istituto Giannina Gaslini, Genoa, Italy.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Anton', 'Affiliation': 'Pediatric Rheumatology Unit, Hospital Sant Joan de Déu, Esplugues de Llobregat, Spain.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'China Novartis Institutes for Biomedical Research Co., Ltd, Beijing, China.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Slade', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, United States.'}, {'ForeName': 'Nicolino', 'Initials': 'N', 'LastName': 'Ruperto', 'Affiliation': 'Clinica Pediatrica e Reumatologia, PRINTO, IRCCS Istituto Giannina Gaslini, Genoa, Italy.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Abrams', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41488']
2159,32783367,Pregnancy outcome and cost-effectiveness comparisons of artificial cycle-prepared frozen embryo transfer with or without GnRH agonist pretreatment for polycystic ovary syndrome: a randomized controlled trial.,"OBJECTIVE


To compare the live birth rate and cost effectiveness of artificial cycle-prepared frozen embryo transfer (AC-FET) with or without GnRH agonist (GnRH-a) pretreatment for women with polycystic ovary syndrome (PCOS).
DESIGN


Open-label, randomized, controlled trial.
SETTING


Reproductive center of a university-affiliated hospital.
SAMPLE


A total of 343 women with PCOS, aged 24-40 years, scheduled for AC-FET and receiving no more than two blastocysts.
METHODS


The pretreatment group (n = 172) received GnRH-a pretreatment while the control group (n = 171) did not. Analysis followed the intention-to-treat (ITT) principle.
MAIN OUTCOME MEASURES


The primary outcome measure was live birth rate. Secondary outcome measures included clinical pregnancy rate, implantation rate, early pregnancy loss rate, and direct treatment costs per FET cycle.
RESULTS


Among the 343 women randomized, 330 (96.2%) underwent embryo transfer and 328 (95.6%) completed the protocols. Live birth rate according to ITT did not differ between the pretreatment and control groups [85/172 (49.4%) versus 92/171 (53.8%), absolute rate difference = -4.4%, 95% CI: -10.8% to 2.0%, P=0.45]. Implantation rate, clinical pregnancy rate, and early pregnancy loss rate also did not differ between groups, but median direct cost per FET cycle was significantly higher in the pretreatment group [7799.2RMB vs. 4438.9 RMB, OR = 1.9, 95%CI: 1.2-3.4, P<0.001]. Median direct cost per live birth was also significantly higher in the pretreatment group [15663.1 RMB vs. 8189.9 RMB, OR = 1.9, 95%CI: 1.2-3.8, P<0.001].
CONCLUSIONS


Pretreatment with GnRH-a does not improve pregnancy outcomes for women with PCOS receiving AC-FET, but significantly increases patient cost.",2020,"Implantation rate, clinical pregnancy rate, and early pregnancy loss rate also did not differ between groups, but median direct cost per FET cycle was significantly higher in the pretreatment group [7799.2RMB vs. 4438.9 RMB, OR = 1.9, 95%CI: 1.2-3.4, P<0.001].","['343 women with PCOS, aged 24-40 years, scheduled for AC-FET and receiving no more than two blastocysts', 'polycystic ovary syndrome', 'women with polycystic ovary syndrome (PCOS', '343 women randomized, 330 (96.2%) underwent embryo transfer and 328', 'Reproductive center of a university-affiliated hospital']","['GnRH-a pretreatment while the control group', 'artificial cycle-prepared frozen embryo transfer (AC-FET) with or without GnRH agonist (GnRH-a) pretreatment', 'artificial cycle-prepared frozen embryo transfer with or without GnRH agonist pretreatment']","['median direct cost per FET cycle', 'patient cost', 'pregnancy outcomes', 'Median direct cost per live birth', 'live birth rate', 'Implantation rate, clinical pregnancy rate, and early pregnancy loss rate', 'live birth rate and cost effectiveness', 'clinical pregnancy rate, implantation rate, early pregnancy loss rate, and direct treatment costs per FET cycle', 'Live birth rate according to ITT']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1281743', 'cui_str': 'Blastocyst structure'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0643582', 'cui_str': '11-(2-fluoroethyl)estradiol'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C3830362', 'cui_str': 'Early Pregnancy Loss'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}]",343.0,0.258207,"Implantation rate, clinical pregnancy rate, and early pregnancy loss rate also did not differ between groups, but median direct cost per FET cycle was significantly higher in the pretreatment group [7799.2RMB vs. 4438.9 RMB, OR = 1.9, 95%CI: 1.2-3.4, P<0.001].","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': 'The Center of Reproductive Medicine, First Affiliated Hospital, Sun Yat-sen University and Guangdong Provincial Key Laboratory of Reproductive Medicine, Guangzhou, China.'}, {'ForeName': 'Minghui', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'The Center of Reproductive Medicine, First Affiliated Hospital, Sun Yat-sen University and Guangdong Provincial Key Laboratory of Reproductive Medicine, Guangzhou, China.'}, {'ForeName': 'Yangxing', 'Initials': 'Y', 'LastName': 'Wen', 'Affiliation': 'The Center of Reproductive Medicine, First Affiliated Hospital, Sun Yat-sen University and Guangdong Provincial Key Laboratory of Reproductive Medicine, Guangzhou, China.'}, {'ForeName': 'Limei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'The Center of Reproductive Medicine, First Affiliated Hospital, Sun Yat-sen University and Guangdong Provincial Key Laboratory of Reproductive Medicine, Guangzhou, China.'}, {'ForeName': 'Canquan', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'The Center of Reproductive Medicine, First Affiliated Hospital, Sun Yat-sen University and Guangdong Provincial Key Laboratory of Reproductive Medicine, Guangzhou, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'The Center of Reproductive Medicine, First Affiliated Hospital, Sun Yat-sen University and Guangdong Provincial Key Laboratory of Reproductive Medicine, Guangzhou, China.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16461']
2160,32783395,The Pro12Ala polymorphism of PPARγ2 modulates beta cell function and failure to oral glucose-lowering drugs in patients with type 2 diabetes.,"AIM


We evaluate whether the Pro12Ala polymorphism of PPARγ2 has a role in the progression of diabetes by modulating the occurrence of treatment failure to glucose-lowering drugs.
MATERIALS AND METHODS


We studied 215 patients with T2D participating in the TOSCA.IT study. All participants were insufficiently controlled (HbA1c 7.0-9.0%) with metformin 2 g/day and were randomly allocated to add-on pioglitazone or a sulfonylurea. Treatment failure was defined as HbA1c ≥8% on two consecutive visits, three months apart.
RESULTS


Carriers or non-carriers of the polymorphism had similar age, body mass index and diabetes duration. Ala carriers had lower fasting plasma insulin, better insulin sensitivity (HOMA2-%S), and worse beta cell secretion (HOMA2-%B) than non-carriers. During 24 months of follow-up, 32.5% among the Ala carriers and 8.6% among non-carriers (P < 0.001) developed treatment failure with a cumulative incidence of 18.6 vs 4.6/100 person-years. Those patients who developed treatment failure were older, had a younger age at diabetes diagnosis (48 ± 10 vs 52 ± 7 years; P = 0.032), higher HbA1c (8.1 ± 0.5 vs 7.7 ± 0.5%; P < 0.001) and lower HOMA2-%B (30 ± 12 vs 46 ± 29; P = 0.015) at study entry, as compared to those who did not develop treatment failure. At multivariate analysis the Pro12Ala polymorphism was significantly associated with treatment failure (HR 4.45; 95% CI 1.79-11.1; P < 0.001); HbA1c at study entry was the other independent predictor of failure in this study population.
CONCLUSIONS


The Pro12Ala polymorphism is associated with a greater insulin sensitivity, reduced beta cell function and a substantially increased risk of treatment failure. This article is protected by copyright. All rights reserved.",2020,"Ala carriers had lower fasting plasma insulin, better insulin sensitivity (HOMA2-%S), and worse beta cell secretion (HOMA2-%B) than non-carriers.","['All participants were insufficiently controlled (HbA1c 7.0-9.0%) with', '215 patients with T2D participating in the TOSCA.IT study', 'Those patients who developed treatment failure were older, had a younger age at diabetes diagnosis (48\u2009±\u200910 vs 52\u2009±\u20097\u2009years; P\u2009=\xa00.032), higher HbA1c (8.1\u2009±\u20090.5 vs 7.7\u2009±\u20090.5%; P\u2009<\u20090.001) and lower HOMA2-%B (30\u2009±\u200912 vs 46\u2009±\u200929; P\xa0=\xa00.015) at study entry, as compared to those who did not develop treatment failure', 'patients with type 2 diabetes']","['pioglitazone or a sulfonylurea', 'metformin']","['fasting plasma insulin, better insulin sensitivity (HOMA2-%S), and worse beta cell secretion (HOMA2-%B']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C4517385', 'cui_str': '0.001'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4517396', 'cui_str': '0.015'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0036536', 'cui_str': 'secretion'}]",215.0,0.194282,"Ala carriers had lower fasting plasma insulin, better insulin sensitivity (HOMA2-%S), and worse beta cell secretion (HOMA2-%B) than non-carriers.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Masulli', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico Naples, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Della Pepa', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico Naples, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Cocozza', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico Naples, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Capasso', 'Affiliation': 'Department of Molecular Medicine and Medical Biotechnologies, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Pignataro', 'Affiliation': 'Department of Molecular Medicine and Medical Biotechnologies, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Marilena', 'Initials': 'M', 'LastName': 'Vitale', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico Naples, Italy.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Gastaldelli', 'Affiliation': 'Institute of Clinical Physiology National Research Council, Pisa, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Russo', 'Affiliation': 'Institute of Clinical Physiology National Research Council, Pisa, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Dolce', 'Affiliation': 'Department of Public Health, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Riccardi', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico Naples, Italy.'}, {'ForeName': 'Angela Albarosa', 'Initials': 'AA', 'LastName': 'Rivellese', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico Naples, Italy.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Vaccaro', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico Naples, Italy.'}]",Diabetes/metabolism research and reviews,['10.1002/dmrr.3392']
2161,32783421,Prospective Clinical Trial of Intravitreal Aflibercept Treat-and-extend Regimen for Diabetic Macular Edema: 1-Year Outcomes.,"PURPOSE


To investigate the efficacy of aflibercept for the treatment of diabetic macular edema via a treat-and-extend regimen.
METHODS


This prospective, single-center, open-label, interventional study involved 30 patients with a best-corrected visual acuity (BCVA) ≤0.6 and a central retinal thickness (CRT) ≥300 μm. The enrolled eyes each received a monthly intravitreal aflibercept injection until the CRT decreased below 300 μm, upon which the administration interval was extended for 1 month until the CRT once again increased to ≥300 μm. Main outcome measures were median BCVA and CRT at 6 and 12 months after initiation of treatment via last observation carried forward analysis, the median number of injections over the 12 months, and the effects on the diabetic retinopathy severity scale (DRSS) score of the patients who completed the 12-month follow-up period.
RESULTS


Of the 30 enrolled patients, 29 and 25 respectively completed the 6- and 12-month follow-up examinations. From baseline to 6 and 12 months after treatment initiation, the median BCVA (logarithm of the minimum angle of resolution) significantly improved from 0.52 to 0.30 and 0.35, respectively, and the median CRT significantly decreased from 439.5 to 268.5 and 249.0 μm, respectively. The median number of injections over the 12-month follow-up period was 6.0. Compared to baseline, the DRSS score at 12 months was improved by 2 steps in 16% of patients; in no cases did the DRSS score worsen or improve by three steps or more.
CONCLUSIONS


When administered in a treat-and-extend regimen, aflibercept is an effective treatment option for diabetic macular edema.",2020,"Compared to baseline, the DRSS score at 12 months was improved by 2 steps in 16% of patients; in no cases did the DRSS score worsen or improve by three steps or more.
","['Of the 30 enrolled patients, 29 and 25 respectively completed the 6- and 12-month follow-up examinations', 'Diabetic Macular Edema', '30 patients with a best-corrected visual acuity (BCVA) ≤0.6 and a central retinal thickness (CRT) ≥300 μm', 'diabetic macular edema']","['Intravitreal Aflibercept Treat-and-extend Regimen', 'aflibercept', 'intravitreal aflibercept injection']","['DRSS score', 'median BCVA', 'median CRT', 'diabetic retinopathy severity scale (DRSS) score', 'median BCVA and CRT', 'median number of injections']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}]","[{'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",30.0,0.0388755,"Compared to baseline, the DRSS score at 12 months was improved by 2 steps in 16% of patients; in no cases did the DRSS score worsen or improve by three steps or more.
","[{'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Mieno', 'Affiliation': 'Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Kazuhito', 'Initials': 'K', 'LastName': 'Yoneda', 'Affiliation': 'Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan. kazuyone@koto.kpu-m.ac.jp.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Terao', 'Affiliation': 'Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Yoshii', 'Affiliation': 'Department of Mathematics and Statistics in Medical Sciences, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kojima', 'Affiliation': 'Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Nagata', 'Affiliation': 'Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Chie', 'Initials': 'C', 'LastName': 'Sotozono', 'Affiliation': 'Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}]",Korean journal of ophthalmology : KJO,['10.3341/kjo.2020.0003']
2162,32778876,Effect of aspirin on cancer incidence and mortality in older adults.,"BACKGROUND


ASPirin in Reducing Events in the Elderly (ASPREE), a randomized double-blind placebo-controlled trial (RCT) of daily low-dose aspirin (100 mg) in older adults, showed an increase in all-cause mortality, primarily due to cancer. In contrast prior RCTs, mainly involving younger individuals, demonstrated a delayed cancer benefit with aspirin. We now report a detailed analysis of cancer incidence and mortality.
METHODS


19,114 Australian and U.S. community-dwelling participants aged 70+ years (U.S. minorities 65+ years) without cardiovascular disease, dementia or physical disability were randomized and followed for a median of 4.7 years. Fatal and non-fatal cancer events, a prespecified secondary endpoint, were adjudicated based on clinical records.
RESULTS


981 cancer events occurred in the aspirin and 952 in the placebo groups. There was no statistically significant difference between groups for all incident cancers (HR = 1.04, 95% CI = 0.95 to 1.14), hematological cancer (HR = 0.98, 95% CI = 0.73 to 1.30), or all solid cancers (HR = 1.05, 95% CI = 0.95 to 1.15), including by specific tumor type. However, aspirin was associated with an increased risk of incident cancer that had metastasized (HR = 1.19, 95% CI = 1.00 to 1.43) or was stage 4 at diagnosis (HR = 1.22, 95% CI = 1.02 to 1.45), and with higher risk of death for cancers that presented at stages 3 (HR = 2.11, 95% CI = 1.03 to 4.33) or 4 (HR = 1.31, 95% CI = 1.04 to 1.64).
CONCLUSIONS


In older adults, aspirin treatment had an adverse effect on later stages of cancer evolution. These findings suggest that in older persons, aspirin may accelerate the progression of cancer and thus, suggest caution with its use in this age group.",2020,"However, aspirin was associated with an increased risk of incident cancer that had metastasized (HR = 1.19, 95% CI = 1.00 to 1.43) or was stage 4 at diagnosis (HR = 1.22, 95% CI = 1.02 to 1.45), and with higher risk of death for cancers that presented at stages 3 (HR = 2.11, 95% CI = 1.03 to 4.33) or 4 (HR = 1.31, 95% CI = 1.04 to 1.64).
","['older persons', '19,114 Australian and U.S. community-dwelling participants aged 70+ years (U.S. minorities 65+ years) without cardiovascular disease, dementia or physical disability were randomized and followed for a median of 4.7 years', 'older adults']","['ASPirin', 'aspirin', 'placebo']","['cancer incidence and mortality', 'adverse effect on later stages of cancer evolution', 'risk of incident cancer', 'hematological cancer']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",19114.0,0.510099,"However, aspirin was associated with an increased risk of incident cancer that had metastasized (HR = 1.19, 95% CI = 1.00 to 1.43) or was stage 4 at diagnosis (HR = 1.22, 95% CI = 1.02 to 1.45), and with higher risk of death for cancers that presented at stages 3 (HR = 2.11, 95% CI = 1.03 to 4.33) or 4 (HR = 1.31, 95% CI = 1.04 to 1.64).
","[{'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne VIC, Australia, The Walter & Eliza Hall Institute of Medical Research, Melbourne VIC, Australia; and Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne VIC, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gibbs', 'Affiliation': 'Walter Reed National Military Medical Center, Bethesda, MD, U.S.'}, {'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Orchard', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne VIC, Australia, The Walter & Eliza Hall Institute of Medical Research, Melbourne VIC, Australia; and Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne VIC, Australia.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne VIC, Australia, The Walter & Eliza Hall Institute of Medical Research, Melbourne VIC, Australia; and Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne VIC, Australia.'}, {'ForeName': 'Wendy B', 'Initials': 'WB', 'LastName': 'Bernstein', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, St. Louis, MO, U.S.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, MD, U.S.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Ford', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Health Research Institute, Hennepin HealthCare, Minneapolis MN, U.S.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haydon', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne VIC, Australia, The Walter & Eliza Hall Institute of Medical Research, Melbourne VIC, Australia; and Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne VIC, Australia.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Kirpach', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne VIC, Australia; and Department of Colorectal Medicine and Genetics, The Royal Melbourne Hospital, VIC, Australia.'}, {'ForeName': 'Finlay', 'Initials': 'F', 'LastName': 'Macrae', 'Affiliation': 'Department of Anatomical Pathology, Alfred Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'McLean', 'Affiliation': 'Division of Geriatrics, Department of Medicine, Hennepin County Medical Center and University of Minnesota, Minneapolis MN, U.S.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Millar', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne VIC, Australia, The Walter & Eliza Hall Institute of Medical Research, Melbourne VIC, Australia; and Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne VIC, Australia.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne VIC, Australia; and Department of Colorectal Medicine and Genetics, The Royal Melbourne Hospital, VIC, Australia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne VIC, Australia, The Walter & Eliza Hall Institute of Medical Research, Melbourne VIC, Australia; and Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne VIC, Australia.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Polekhina', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne VIC, Australia, The Walter & Eliza Hall Institute of Medical Research, Melbourne VIC, Australia; and Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne VIC, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne VIC, Australia, The Walter & Eliza Hall Institute of Medical Research, Melbourne VIC, Australia; and Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne VIC, Australia.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Richmond', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Health Research Institute, Hennepin HealthCare, Minneapolis MN, U.S.'}, {'ForeName': 'Luz Maria', 'Initials': 'LM', 'LastName': 'Rodríguez', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, St. Louis, MO, U.S.'}, {'ForeName': 'Raj C', 'Initials': 'RC', 'LastName': 'Shah', 'Affiliation': 'Department of Medicine, University of Pittsburgh, PA, U.S.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Tie', 'Affiliation': 'Walter Reed National Military Medical Center, Bethesda, MD, U.S.'}, {'ForeName': 'Asad', 'Initials': 'A', 'LastName': 'Umar', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Health Research Institute, Hennepin HealthCare, Minneapolis MN, U.S.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'van Londen', 'Affiliation': 'Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital, Boston, MA, U.S.'}, {'ForeName': 'Kathlyn', 'Initials': 'K', 'LastName': 'Ronaldson', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne VIC, Australia, The Walter & Eliza Hall Institute of Medical Research, Melbourne VIC, Australia; and Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne VIC, Australia.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne VIC, Australia, The Walter & Eliza Hall Institute of Medical Research, Melbourne VIC, Australia; and Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne VIC, Australia.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne VIC, Australia, The Walter & Eliza Hall Institute of Medical Research, Melbourne VIC, Australia; and Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne VIC, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zalcberg', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne VIC, Australia, The Walter & Eliza Hall Institute of Medical Research, Melbourne VIC, Australia; and Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne VIC, Australia.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Chan', 'Affiliation': 'Clinical and Translational Epidemiology Unit, Massachusetts General Hospital, MA. U.S.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the National Cancer Institute,['10.1093/jnci/djaa114']
2163,32772583,"Effectiveness of a structured physical rehabilitation program on the physical fitness, mental health and pain for Chinese patients with major depressive disorders in Hong Kong - a randomized controlled trial with 9-month follow-up outcomes.","PURPOSE


The long-term and specific impacts on the physical and mental health for Chinese people with major depressive disorders (MDD) are not well-studied. The aim of the study is to investigate both short-and long-term effects of a structured physical rehabilitation program on the physical and mental health and pain for Chinese patients with MDD.
METHODS


84 Chinese patients with MDD were randomized to intervention ( n  = 42) or control group ( n  = 42). Intervention group received a 12-week physical rehabilitation program and the control group with 12-week waiting period followed the same pathway as the intervention group afterwards for longitudinal analysis. Data were collected at baseline (T1), end of 12-week program (T2) and 9-month follow-up period (T3).
RESULTS


Significant pre- and post-intervention improvements were noted in cardiopulmonary function, depressive symptoms, pain, body composition, muscle strength and flexibility for the intervention group. Although mild attenuation is noted from T2 to T3, subjects without exercise habit experienced significant decline in cardiopulmonary function, depressive symptoms and pain ( p  < 0.05) but not in those who developed exercise habit ( p  > 0.05).
CONCLUSION


Structured physical rehabilitation program could improve physical and mental fitness and pain for Chinese MDD patients. Its effects could be sustained up to 9 months after cessation of the program provided that people establish their own exercise habit. IMPLICATIONS FOR REHABILITATION Exercise is an effective means of improving physical and mental health and pain for people with major depressive disorders (MDD). People with MDD have multiple reasons, both physically and psychosocially, for physical deconditioning and hurdles for exercise. Structured supervised exercise program can enhance physical and mental health and may likely enhance exercise compliance in this population.",2020,"RESULTS


Significant pre- and post-intervention improvements were noted in cardiopulmonary function, depressive symptoms, pain, body composition, muscle strength and flexibility for the intervention group.","['people with major depressive disorders (MDD', 'Chinese people with major depressive disorders (MDD', '84 Chinese patients with MDD', 'Chinese patients with MDD', 'Chinese MDD patients', 'Chinese patients with major depressive disorders in Hong Kong ']","['Structured supervised exercise program', 'physical rehabilitation program and the control group with 12-week waiting period followed the same pathway as the intervention', 'Structured physical rehabilitation program', 'structured physical rehabilitation program']","['physical fitness, mental health and pain', 'physical and mental fitness and pain', 'cardiopulmonary function, depressive symptoms, pain, body composition, muscle strength and flexibility', 'cardiopulmonary function, depressive symptoms and pain', 'physical and mental health and pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",84.0,0.0285504,"RESULTS


Significant pre- and post-intervention improvements were noted in cardiopulmonary function, depressive symptoms, pain, body composition, muscle strength and flexibility for the intervention group.","[{'ForeName': 'Rosanna Mei Wa', 'Initials': 'RMW', 'LastName': 'Chau', 'Affiliation': 'Physiotherapy Department, Kowloon Hospital, Hong Kong, Hong Kong SAR.'}, {'ForeName': 'Amy Ying Yu', 'Initials': 'AYY', 'LastName': 'Tsui', 'Affiliation': 'Physiotherapy Department, Kowloon Hospital, Hong Kong, Hong Kong SAR.'}, {'ForeName': 'Eva Yee Wah', 'Initials': 'EYW', 'LastName': 'Wong', 'Affiliation': 'Physiotherapy Department, Kowloon Hospital, Hong Kong, Hong Kong SAR.'}, {'ForeName': 'Eddy Yu Yeung', 'Initials': 'EYY', 'LastName': 'Cheung', 'Affiliation': 'Physiotherapy Department, Kowloon Hospital, Hong Kong, Hong Kong SAR.'}, {'ForeName': 'Debby Yat Ching', 'Initials': 'DYC', 'LastName': 'Chan', 'Affiliation': 'Physiotherapy Department, Kowloon Hospital, Hong Kong, Hong Kong SAR.'}, {'ForeName': 'Polly Mo Yee', 'Initials': 'PMY', 'LastName': 'Lau', 'Affiliation': 'Physiotherapy Department, Kowloon Hospital, Hong Kong, Hong Kong SAR.'}, {'ForeName': 'Roger Man Kin', 'Initials': 'RMK', 'LastName': 'Ng', 'Affiliation': 'Department of Psychiatry, Kowloon Hospital, Hong Kong, Hong Kong SAR.'}]",Disability and rehabilitation,['10.1080/09638288.2020.1800833']
2164,32772684,Direct Transfer to Angio-Suite Versus Computed Tomography-Transit in Patients Receiving Mechanical Thrombectomy: A Randomized Trial.,"BACKGROUND AND PURPOSE


To quantify workflow metrics in patients receiving stroke imaging (noncontrast-enhanced computed tomography [CT] and CT-angiography) in either a computed-tomography scanner suite (CT-Transit [CTT]) or an angio-suite (direct transfer to angio-suite-[DTAS]-using flat-panel CT) before undergoing mechanical thrombectomy.
METHODS


Prospective, single-center investigator initiated randomized controlled trial in a comprehensive stroke center focusing on time from imaging to groin puncture (primary end point) and time from hospital admission to final angiographic result (secondary end point) in patients receiving mechanical thrombectomy for anterior circulation large vessel occlusion after randomization to the CTT or DTAS pathway.
RESULTS


The trial was stopped early after the enrollment of n=60 patients (CTT: n=34/60 [56.7 %]; DTAS: n=26/60 [43.3%]) of n=110 planned patients because of a preplanned interim analysis. Time from imaging to groin puncture was shorter in DTAS-patients (in minutes, median [interquartile range]: CTT: 26 [23-32]; DTAS: 19 [15-23];  P  value: 0.001). Time from hospital admission to stroke imaging was shorter in patients randomized to DTAS (CTT: 12 (7-18); DTAS: 21 (15-25),  P  value: 0.007). Time from hospital admission to final angiographic reperfusion was comparable between patient groups (CTT: 78 [58-92], DTAS: 80 [66-118];  P  value: 0.067).
CONCLUSIONS


This trial showed a reduction in time from imaging to groin-puncture when patients are transferred directly to the angiosuite for advanced stroke-imaging compared with imaging in a CT scanner suite. This time saving was outweighed by a longer admission to imaging time and could not translate into a shorter time to final angiographic reperfusion in this trial.",2020,Time from hospital admission to stroke imaging was shorter in patients randomized to DTAS,"['n=60 patients (CTT: n=34/60 [56.7 %]; DTAS', 'Patients Receiving Mechanical Thrombectomy', 'patients receiving mechanical thrombectomy for anterior circulation large vessel occlusion after randomization to the CTT or DTAS pathway', 'patients receiving']","['angio-suite (direct transfer to angio-suite-[DTAS]-using flat-panel CT', 'Direct Transfer to Angio-Suite Versus Computed Tomography-Transit', 'stroke imaging (noncontrast-enhanced computed tomography [CT] and CT-angiography', 'DTAS', 'computed-tomography scanner suite (CT-Transit [CTT']","['Time from imaging to groin puncture', 'Time from hospital admission to final angiographic reperfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]",,0.0900532,Time from hospital admission to stroke imaging was shorter in patients randomized to DTAS,"[{'ForeName': 'Johannes A R', 'Initials': 'JAR', 'LastName': 'Pfaff', 'Affiliation': 'Department of Neuroradiology (J.A.R.P., C.H., C.U., M.B., M.A.M.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Schönenberger', 'Affiliation': 'Department of Neurology (S.S., S.N., P.A.R.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Herweh', 'Affiliation': 'Department of Neuroradiology (J.A.R.P., C.H., C.U., M.B., M.A.M.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ulfert', 'Affiliation': 'Department of Neuroradiology (J.A.R.P., C.H., C.U., M.B., M.A.M.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Nagel', 'Affiliation': 'Department of Neurology (S.S., S.N., P.A.R.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Ringleb', 'Affiliation': 'Department of Neurology (S.S., S.N., P.A.R.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bendszus', 'Affiliation': 'Department of Neuroradiology (J.A.R.P., C.H., C.U., M.B., M.A.M.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Markus A', 'Initials': 'MA', 'LastName': 'Möhlenbruch', 'Affiliation': 'Department of Neuroradiology (J.A.R.P., C.H., C.U., M.B., M.A.M.), Heidelberg University Hospital, Germany.'}]",Stroke,['10.1161/STROKEAHA.120.029905']
2165,32772701,Is Taping Alone an Efficient Presurgical Infant Orthopedic Approach in Infants With Unilateral Cleft Lip and Palate? A Randomized Controlled Trial.,"OBJECTIVE


The aim of the current randomized controlled trial (RCT) was to assess the effectiveness of taping alone in changing the maxillary arch dimensions (MADs) in infants with unilateral complete cleft lip and palate (UCLP) before surgical lip repair.
DESIGN


A prospective, balanced, randomized, parallel-group, single-blinded, controlled trial.
SETTING


All the steps of the current study were carried in the Department of Orthodontics, Cairo University in Egypt.
PARTICIPANTS


Thirty-one, nonsyndromic infants with UCLP.
INTERVENTIONS


The eligible infants were randomly assigned to either no-treatment (control) or taping groups. In the taping group, all the infants received horizontal tape between the 2 labial segments aiming to decrease the cleft gap. No other interventions were performed to infants included in this group. Rubber base impressions were made to all the included infants in both groups at the beginning of the treatment (T1) and directly before surgical lip repair (T2). All the produced models were scanned using a desktop scanner producing digital models for outcome assessment.
MAIN OUTCOMES MEASURES


A blinded assessor carried out all the MAD measurements virtually on the produced digital models at the beginning (T1) and after (T2) treatment.
RESULTS


Clinically and/or statistically significant changes in all the measured MADs were recorded in the taping group at T2 before surgical lip repair in comparison to the control group.
CONCLUSIONS


It seems that taping alone is an efficient tool in changing the MADs before surgical lip repair in infants with UCLP.",2020,"Clinically and/or statistically significant changes in all the measured MADs were recorded in the taping group at T2 before surgical lip repair in comparison to the control group.
","['Thirty-one, nonsyndromic infants with UCLP', 'infants with unilateral complete cleft lip and palate (UCLP) before surgical lip repair', 'All the steps of the current study were carried in the Department of Orthodontics, Cairo University in Egypt', 'infants with UCLP', 'Infants With Unilateral Cleft Lip and Palate']","['horizontal tape', 'no-treatment (control) or taping groups']",['MADs'],"[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0158646', 'cui_str': 'Cleft palate with cleft lip'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0192038', 'cui_str': 'Repair of lip'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}]","[{'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",,0.0747108,"Clinically and/or statistically significant changes in all the measured MADs were recorded in the taping group at T2 before surgical lip repair in comparison to the control group.
","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abd El-Ghafour', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Cairo University, Egypt.'}, {'ForeName': 'Mamdouh A', 'Initials': 'MA', 'LastName': 'Aboulhassan', 'Affiliation': 'Department of Pediatric\xa0Plastic Surgery, Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Amr Ragab', 'Initials': 'AR', 'LastName': 'El-Beialy', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Cairo University, Egypt.'}, {'ForeName': 'Mona M Salah', 'Initials': 'MMS', 'LastName': 'Fayed', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Cairo University, Egypt.'}, {'ForeName': 'Faten Hussein Kamel', 'Initials': 'FHK', 'LastName': 'Eid', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Cairo University, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'El-Gendi', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Cairo University, Egypt.'}, {'ForeName': 'Dawlat', 'Initials': 'D', 'LastName': 'Emara', 'Affiliation': 'Department of Plastic Surgery, Faculty of Medicine, Cairo University, Egypt.'}]",The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association,['10.1177/1055665620944757']
2166,32772733,"Serum Perfluoroalkyl Substances, Vaccine Responses, and Morbidity in a Cohort of Guinea-Bissau Children.","BACKGROUND


Perfluoroalkyl substances (PFAS) are a group of widely used persistent chemicals with suspected immunotoxic effects.
OBJECTIVES


The present study aimed to examine the association between infant PFAS exposure and antibody responses to measles vaccination as well as morbidity in a low-income country.
METHODS


In a randomized controlled trial, children from Guinea-Bissau, West Africa, were followed from inclusion (4-7 months of age) through 2 years of age. Half the children received two measles vaccinations (at inclusion and at 9 months of age), and the other half received only one (at 9 months of age). In a subset of 237 children, six PFAS were quantified in serum at inclusion, and measles antibody concentrations were assessed at inclusion and at approximately 9 months and 2 years of age. At inclusion and at the 9-month visit, mothers were interviewed about infant morbidity.
RESULTS


All but one child had detectable serum concentrations of all six PFAS, although levels were lower than seen elsewhere. A doubling in perfluorooctane sulfonic acid (PFOS) and perfluorodecanoic acid (PFDA) were associated with 21% (95% CI: 2, 37%) and 25% (95% CI: 1, 43%), respectively, lower measles antibody concentrations at the 9-month visit among the children who had received a measles vaccine at inclusion. Elevated serum PFAS concentrations were also associated with reduced prevaccination measles antibody concentrations and increased morbidity.
DISCUSSION


The present study documents that PFAS exposure has reached West Africa and that infants show PFAS-associated increases in morbidity and decreases in measles-specific antibody concentrations before and after vaccination. These findings support the evidence on PFAS immunotoxicity at comparatively low serum concentrations. https://doi.org/10.1289/EHP6517.",2020,"Elevated serum PFAS concentrations were also associated with reduced prevaccination measles antibody concentrations and increased morbidity.
","['children from Guinea-Bissau, West Africa, were followed from inclusion (4-7 months of age) through 2 years of age']","['Perfluoroalkyl substances (PFAS', 'https://doi.org/10.1289/EHP6517']","['Elevated serum PFAS concentrations', 'PFAS immunotoxicity', 'morbidity', 'Serum Perfluoroalkyl Substances, Vaccine Responses, and Morbidity', 'perfluorooctane sulfonic acid (PFOS) and perfluorodecanoic acid (PFDA']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018387', 'cui_str': 'Guinea-Bissau'}, {'cui': 'C0001747', 'cui_str': 'Western Africa'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439861', 'cui_str': 'Substance'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0457929', 'cui_str': 'Substance concentration'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0172926', 'cui_str': 'perfluorooctane sulfonic acid'}, {'cui': 'C0070396', 'cui_str': 'perfluorodecanoic acid'}]",237.0,0.111341,"Elevated serum PFAS concentrations were also associated with reduced prevaccination measles antibody concentrations and increased morbidity.
","[{'ForeName': 'Clara Amalie Gade', 'Initials': 'CAG', 'LastName': 'Timmermann', 'Affiliation': 'Research Unit of Environmental Medicine, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Kristoffer Jarlov', 'Initials': 'KJ', 'LastName': 'Jensen', 'Affiliation': 'Research Center for Vitamins and Vaccines, Bandim Health Project, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Flemming', 'Initials': 'F', 'LastName': 'Nielsen', 'Affiliation': 'Research Unit of Environmental Medicine, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Esben', 'Initials': 'E', 'LastName': 'Budtz-Jørgensen', 'Affiliation': 'Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'van der Klis', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands.'}, {'ForeName': 'Christine Stabell', 'Initials': 'CS', 'LastName': 'Benn', 'Affiliation': 'Research Center for Vitamins and Vaccines, Bandim Health Project, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Grandjean', 'Affiliation': 'Research Unit of Environmental Medicine, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Ane Bærent', 'Initials': 'AB', 'LastName': 'Fisker', 'Affiliation': 'Research Center for Vitamins and Vaccines, Bandim Health Project, Statens Serum Institut, Copenhagen, Denmark.'}]",Environmental health perspectives,['10.1289/EHP6517']
2167,32772792,Influence of Anxiety on Baseline Cognitive Testing and Symptom Reporting in Adolescent Student Athletes.,"INTRODUCTION


Anxiety symptoms are commonly endorsed by student athletes. This study examined the possible influence of anxiety on baseline cognitive testing and symptom reporting in a large sample of adolescent student athletes.
METHODS


Participants were 37,945 adolescent student athletes from the state of Maine who completed baseline testing using ImPACT®. ImPACT® includes an evaluation of cognitive functioning and a questionnaire assessing the presence and severity of common post-concussion symptoms. Participants were divided into high and low anxiety groups based on endorsement of anxiety-like symptoms.
RESULTS


Student athletes in the high anxiety group were more likely to be girls and to have a greater lifetime history of treatment for mental health problems and headaches (ps<.001). The high anxiety group scored slightly lower on cognitive tests (Cohen's ds=0.15-0.26) and reported a much greater amount of baseline preseason symptoms (Cohen's d=3.38). More than eight out of ten youth in the high anxiety group (82.7%) met International Statistical Classification of Diseases and Related Health Problems-10th Revision (ICD-10) symptom criteria for at least a mild form of the postconcussional syndrome compared to less than two out of ten (18.4%) in the low anxiety group.
CONCLUSION


Students in the high anxiety group had slightly lower scores on neurocognitive testing, but the differences were not practically meaningful; however, they endorsed dramatically more physical, cognitive, and emotional symptoms. Anxiety can mimic the ICD-10 postconcussional syndrome in adolescent student athletes at baseline, when they have not been injured.",2020,The high anxiety group scored slightly lower on cognitive tests (Cohen's ds=0.15-0.26) and reported a much greater amount of baseline preseason symptoms (Cohen's d=3.38).,"['Participants were 37,945 adolescent student athletes from the state of Maine who completed baseline testing using ImPACT®', 'Adolescent Student Athletes', 'adolescent student athletes', 'Student athletes in the high anxiety group']",[],"['physical, cognitive, and emotional symptoms', 'International Statistical Classification of Diseases and Related Health Problems-10th Revision (ICD-10) symptom criteria', 'neurocognitive testing', 'cognitive tests']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0024497', 'cui_str': 'Maine'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0870733', 'cui_str': 'International Statistical Classification of Diseases and Related Health Problems'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",37945.0,0.02765,The high anxiety group scored slightly lower on cognitive tests (Cohen's ds=0.15-0.26) and reported a much greater amount of baseline preseason symptoms (Cohen's d=3.38).,"[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Champigny', 'Affiliation': 'York University, 7991, Psychology, Toronto, Ontario, Canada; cclaire@yorku.ca.'}, {'ForeName': 'Jennine', 'Initials': 'J', 'LastName': 'Rawana', 'Affiliation': 'York University, 7991, Psychology, Toronto, Ontario, Canada; rawana@yorku.ca.'}, {'ForeName': 'Grant L', 'Initials': 'GL', 'LastName': 'Iverson', 'Affiliation': 'Harvard Medical School, Department of Physical Medicine and Rehabilitation, 79/96 Thirteenth Street, Charlestown, Massachusetts, United States, 02129.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Maxwell', 'Affiliation': 'Colby College, Waterville, United States; bmaxwell@colby.edu.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Berkner', 'Affiliation': 'University of New England College of Osteopathic Medicine, 115985, Biddeford, Maine, United States; pberkner@une.edu.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Wojtowicz', 'Affiliation': 'York University, 7991, Psychology, 4700 Keele Street, Toronto, Ontario, Canada, M3J 1P3; magdawoj@yorku.ca.'}]",Journal of neurotrauma,['10.1089/neu.2020.7079']
2168,32772812,Therapeutic effect of AiWalker on balance and walking ability in patients with stroke: A pilot study.,"BACKGROUND


AiWalker is a newly developed robot-assisted gait training system, which features over-ground walking paradigm and somatosensory stimulation during training compared to commonly-used robot-assisted gait training devices (e.g. Lokomat). However, no study has examined its true therapeutic effect and possible mechanism or mediating factor(s).
OBJECTIVES


To investigate 1) the therapeutic effect of AiWalker on the balance and walking ability in patients with stroke, and 2) whether the improvement in somatosensory function represents one of the possible mediating factors for such effect.
METHODS


Three patients with impaired balance and walking ability due to stroke were recruited. Two patients received AiWalker training plus conventional training; while the other one only experienced conventional training. Standing balance and walking ability were assessed before and after all the training, which were represented by 6 variables. Lower limb somatosensory function was examined using Fugl-Meyer Assessment Scale.
RESULTS


Five out of the 6 variables showed greater changes in patients who received AiWalker training compared to the one who only experienced conventional training. Greater improvement in lower limb somatosensory function was observed in one patient who received AiWalker training compared to the one who only experienced conventional training.
CONCLUSION


The novel robot-assisted gait training system may elicit greater improvement of balance and walking ability in patients with stroke compared to conventional interventions. Lower limb somatosensory function may be improved by AiWalker, and its improvement might represent one of the possible mediating factors for the therapeutic effect of AiWalker on balance and walking ability.",2020,The novel robot-assisted gait training system may elicit greater improvement of balance and walking ability in patients with stroke compared to conventional interventions.,"['Three patients with impaired balance and walking ability due to stroke were recruited', 'patients with stroke, and 2', 'patients with stroke']","['AiWalker', 'AiWalker training plus conventional training; while the other one only experienced conventional training', 'AiWalker training']","['balance and walking ability', 'Standing balance and walking ability', 'Lower limb somatosensory function', 'lower limb somatosensory function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",3.0,0.0170889,The novel robot-assisted gait training system may elicit greater improvement of balance and walking ability in patients with stroke compared to conventional interventions.,"[{'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': ""Department of Rehabilitation Medicine, The Third Affiliated Hospital, Sun Yat-sen University , Guangzhou, People's Republic of China.""}, {'ForeName': 'Kui', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': ""Department of Rehabilitation Medicine, The Third Affiliated Hospital, Sun Yat-sen University , Guangzhou, People's Republic of China.""}, {'ForeName': 'Danli', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ""Department of Rehabilitation Medicine, The Third Affiliated Hospital, Sun Yat-sen University , Guangzhou, People's Republic of China.""}, {'ForeName': 'Peirong', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ""Department of Rehabilitation Medicine, The Third Affiliated Hospital, Sun Yat-sen University , Guangzhou, People's Republic of China.""}, {'ForeName': 'Zulin', 'Initials': 'Z', 'LastName': 'Dou', 'Affiliation': ""Department of Rehabilitation Medicine, The Third Affiliated Hospital, Sun Yat-sen University , Guangzhou, People's Republic of China.""}]",Topics in stroke rehabilitation,['10.1080/10749357.2020.1802969']
2169,32772826,Neural signatures of sleep recovery following melatonin treatment for pediatric concussion.,"Evidence-based treatments for children with persistent post-concussion symptoms (PPCS) are few and limited. Common PPCS complaints such as sleep disturbance and fatigue could be ameliorated via the supplementation of melatonin, which has significant neuroprotective and anti-inflammatory properties. This study aims to identify neural signatures of melatonin treatment with changes in sleep disturbances and clinical recovery in a pediatric cohort with PPCS. We examined structural and functional neuroimaging (MRI) in 62 children with PPCS in a randomized, double-blind, placebo-controlled trial of 3mg or 10mg of melatonin (NCT01874847). The primary outcome was the total youth self-report Post-Concussion Symptom Inventory (PCSI) score after 28 days of treatment. Secondary outcomes included the change in the sleep domain PCSI score and sleep-wake behavior (assessed using wrist-worn actigraphy). Whole-brain analyses of (i) functional connectivity (FC) of resting-state fMRI, and (ii) structural grey matter (GM) volumes via voxel-based morphometry were assessed immediately before and after melatonin treatment and compared to placebo in order to identify neural effects of melatonin treatment. Increased FC of posterior default mode network (DMN) regions with visual, somatosensory and dorsal networks was detected in the melatonin groups over time. FC increases also corresponded with reduced wake periods (r=-0.27, p=0.01). Children who did not recover (n=39) demonstrated significant FC increases within anterior DMN and limbic regions compared to those that did recover (i.e. PCSI scores returned to pre-injury level n=23) over time, (p=0.026). Increases in GM volume within the posterior cingulate cortex were found to correlate with reduced wakefulness after sleep onset (r=-0.32, p=0.001) and sleep symptom improvement (r=0.29, p=0.02). Although melatonin treatment did not improve PPCS overall clinically, our study finds that melatonin treatment significantly improved subjective and objective sleep parameters with related function-structure relationships within and between brain regions interacting with the DMN.",2020,"Children who did not recover (n=39) demonstrated significant FC increases within anterior DMN and limbic regions compared to those that did recover (i.e. PCSI scores returned to pre-injury level n=23) over time, (p=0.026).","['pediatric cohort with PPCS', 'pediatric concussion', 'children with persistent post-concussion symptoms (PPCS', '62 children with PPCS']","['melatonin', 'placebo']","['FC increases within anterior DMN and limbic regions', 'subjective and objective sleep parameters', 'reduced wakefulness after sleep onset', 'total youth self-report Post-Concussion Symptom Inventory (PCSI) score', 'change in the sleep domain PCSI score and sleep-wake behavior (assessed using wrist-worn actigraphy', 'Increased FC of posterior default mode network (DMN) regions with visual, somatosensory and dorsal networks', 'Whole-brain analyses of (i) functional connectivity (FC) of resting-state fMRI, and (ii) structural grey matter (GM) volumes via voxel-based morphometry', 'GM volume', 'FC', 'sleep symptom improvement']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0546983', 'cui_str': 'Postconcussion syndrome'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0546983', 'cui_str': 'Postconcussion syndrome'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4523852', 'cui_str': 'Voxel-based morphometry'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",62.0,0.354803,"Children who did not recover (n=39) demonstrated significant FC increases within anterior DMN and limbic regions compared to those that did recover (i.e. PCSI scores returned to pre-injury level n=23) over time, (p=0.026).","[{'ForeName': 'Kartik', 'Initials': 'K', 'LastName': 'Iyer', 'Affiliation': 'University of Queensland, 1974, Medicine , 62 Graham Street, Brisbane, Queensland, Australia, 4072.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Zalesky', 'Affiliation': 'The University of Melbourne, Melbourne, Victoria, Australia; azalesky@unimelb.edu.au.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cocchi', 'Affiliation': 'QIMR Berghofer Medical Research Institute, 56362, Herston, Queensland, Australia; Luca.Cocchi@qimrberghofer.edu.au.'}, {'ForeName': 'Karen Maria', 'Initials': 'KM', 'LastName': 'Barlow', 'Affiliation': 'University of Queensland Faculty of Medicine and Biomedical Sciences, 420004, Child Health Research Centre, Rm 610, level 6, Childrens Health Research Centre, 62 Graham Street, South Brisbane, South Brisbane, Queensland, Australia, 4010.'}]",Journal of neurotrauma,['10.1089/neu.2020.7200']
2170,32772853,Benefits of a support programme for family caregivers of patients at the end of life: A randomised controlled trial.,"This study aims to analyse the impact that a psychological intervention programme has on the emotional state of family caregivers of patients at the end of life. The study is longitudinal with two arms (control and experimental). Data was collected from 154 primary family caregivers of patients at the end of life as well as from their respective 154 care-recipients. The intervention programme has shown its effectiveness in reducing anxiety, emotional distress and burden in the family caregivers of end-of-life patients. A reduction of anxiety of patients whose family caregivers participated in the intervention was also observed.",2020,"The intervention programme has shown its effectiveness in reducing anxiety, emotional distress and burden in the family caregivers of end-of-life patients.","['154 primary family caregivers of patients at the end of life as well as from their respective 154 care-recipients', 'family caregivers of patients at the end of life']",['psychological intervention programme'],[],"[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],154.0,0.0261455,"The intervention programme has shown its effectiveness in reducing anxiety, emotional distress and burden in the family caregivers of end-of-life patients.","[{'ForeName': 'Ana Lucila', 'Initials': 'AL', 'LastName': 'Soto-Rubio', 'Affiliation': 'University of Valencia, Spain.'}, {'ForeName': 'Selene', 'Initials': 'S', 'LastName': 'Valero-Moreno', 'Affiliation': 'University of Valencia, Spain.'}, {'ForeName': 'Marián', 'Initials': 'M', 'LastName': 'Pérez-Marín', 'Affiliation': 'University of Valencia, Spain.'}]",Journal of health psychology,['10.1177/1359105320944993']
2171,32772857,A randomized trial of a brief behavioral health lifestyle program for outpatient cardiology clinics.,"Research on lifestyle programs for patients with coronary artery disease (CAD) has largely recruited from hospitals and/or recruited following acute coronary syndrome. By contrast, this study evaluated a 3-session behavioral health program for patients with stable CAD treated in an outpatient cardiology clinic. Thirty-three patients were randomized to the behavioral lifestyle intervention or to Treatment as Usual (TAU). A priori feasibility and acceptability criteria were met, and reliable change analyses revealed that at post-treatment and 30-day follow-up, significantly more intervention participants than TAU participants exhibited increased self-efficacy compared with baseline.",2020,"A priori feasibility and acceptability criteria were met, and reliable change analyses revealed that at post-treatment and 30-day follow-up, significantly more intervention participants than TAU participants exhibited increased self-efficacy compared with baseline.","['Thirty-three patients', 'outpatient cardiology clinics', 'patients with stable CAD treated in an outpatient cardiology clinic', 'patients with coronary artery disease (CAD']","['behavioral lifestyle intervention or to Treatment as Usual (TAU', 'behavioral health lifestyle program']",['self-efficacy'],"[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3810847', 'cui_str': 'Cardiology clinic'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",33.0,0.0270214,"A priori feasibility and acceptability criteria were met, and reliable change analyses revealed that at post-treatment and 30-day follow-up, significantly more intervention participants than TAU participants exhibited increased self-efficacy compared with baseline.","[{'ForeName': 'Chelsea H', 'Initials': 'CH', 'LastName': 'Wiener', 'Affiliation': 'University of Central Florida, USA.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Cassisi', 'Affiliation': 'University of Central Florida, USA.'}, {'ForeName': 'Cerissa L', 'Initials': 'CL', 'LastName': 'Blaney', 'Affiliation': 'University of Central Florida, USA.'}, {'ForeName': 'Amie R', 'Initials': 'AR', 'LastName': 'Newins', 'Affiliation': 'University of Central Florida, USA.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Gros', 'Affiliation': 'University of Central Florida, USA.'}]",Journal of health psychology,['10.1177/1359105320945003']
2172,32773226,Effect of Ezetimibe + Pitavastatin on Cardiovascular Outcomes in Patients with ST-Segment Elevation Myocardial Infarction (from the HIJ-PROPER Study).,"Lipid-lowering therapy is necessary to reduce cardiovascular event rates in patients with ST-segment elevation myocardial infarction (STEMI). This study aimed to evaluate the effect of intensive lipid-lowering therapy, which comprised pitavastatin and ezetimibe, on patients with STEMI. We therefore undertook a post hoc subanalysis of the HIJ-PROPER study's data that examined the clinical outcomes of the patients with dyslipidemia and STEMI (n = 880) who received pitavastatin and ezetimibe therapy (intensive lipid-lowering therapy group) or pitavastatin monotherapy (standard lipid-lowering therapy group), and we evaluated their cardiovascular events. The primary end point was a composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, unstable angina, and ischemia-driven revascularization. During the median 3.4-year follow-up period, the cumulative rates of the primary end point were 31.9% and 39.7% in the intensive lipid-lowering therapy and standard lipid-lowering therapy groups, respectively (hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.62 to 0.97; p = 0.02). Compared with the standard lipid-lowering therapy group, the intensive lipid-lowering therapy group had significantly lower all-cause death (6.9% vs 3.2%; HR, 0.45; 95% CI, 0.23 to 1.84; p = 0.01) and nonfatal stroke (2.9% vs 1.6%; HR, 0.77; 95% CI, 0.62 to 0.97; p = 0.02) rates. Patients with pitavastatin and ezetimibe therapy, as compared with pitavastatin monotherapy, had a lower cardiovascular event in STEMI patients. In conclusion, adding ezetimibe to statin therapy may be beneficial for patients with dyslipidemia and STEMI.",2020,Lipid-lowering therapy is necessary to reduce cardiovascular event rates in patients with ST-segment elevation myocardial infarction (STEMI).,"['Patients with ST-Segment Elevation Myocardial Infarction (from the HIJ-PROPER Study', 'patients with dyslipidemia and STEMI', 'patients with dyslipidemia and STEMI (n\u202f=\u202f880) who received', 'patients with STEMI', 'patients with ST-segment elevation myocardial infarction (STEMI']","['intensive lipid-lowering therapy, which comprised pitavastatin and ezetimibe', 'Lipid-lowering therapy', 'pitavastatin and ezetimibe therapy (intensive lipid-lowering therapy group) or pitavastatin monotherapy (standard lipid-lowering therapy group', 'ezetimibe', 'pitavastatin and ezetimibe therapy', 'Ezetimibe\u202f+\u202fPitavastatin', 'pitavastatin monotherapy', 'standard lipid-lowering therapy']","['cumulative rates', 'cause death', 'cardiovascular event rates', 'nonfatal stroke', 'Cardiovascular Outcomes', 'composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, unstable angina, and ischemia-driven revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",880.0,0.0372168,Lipid-lowering therapy is necessary to reduce cardiovascular event rates in patients with ST-segment elevation myocardial infarction (STEMI).,"[{'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Otsuki', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Arashi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Yamaguchi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan. Electronic address: j.yamaguchi0110@gmail.com.""}, {'ForeName': 'Erisa', 'Initials': 'E', 'LastName': 'Kawada-Watanabe', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Hagiwara', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}]",The American journal of cardiology,['10.1016/j.amjcard.2020.06.069']
2173,32773268,Combination Effect of High-Dose Preoperative and Periarticular Steroid Injection in Total Knee Arthroplasty. A Randomized Controlled Study.,"BACKGROUND


Postoperative pain remains a major barrier to a patient's recovery after total knee arthroplasty (TKA). Periarticular corticosteroids in local infiltration analgesics (LIA) and high-dose intravenous corticosteroids have individually shown to improve pain control after TKA. However, potential interactions between them have not been investigated. This study aims to evaluate any combination effect of both routes of corticosteroids in TKA.
METHODS


This is a double-blinded, paired, randomized controlled trial involving 1-stage bilateral TKAs. All received 16 mg of dexamethasone intravenously. One knee was randomized to receive LIA with 40 mg of triamcinolone, while the other knee receives LIA without corticosteroids. For each patient, one knee was affected by intravenous steroids only, while the other was under the combined effect of intravenous and periarticular steroids (IVPAS). Knee pain, Southampton wound scores, and functional knee scores (Knee Society Knee Score and Oxford Knee Scores) were compared between knees of the same patient.
RESULTS


Forty-six patients (92 TKAs) were included. IVPAS knees showed significantly lower visual analog scale scores from day 1 to 6 weeks (P < .05) and a larger range of movement from day 2 to 4 (P < .05). IVPAS knees achieved active straight leg raise earlier than intravenous steroids (1.6 vs 2.3 days, P < .05). No differences in Southampton wound scores and functional knee scores for up to 1 year.
CONCLUSION


Combining intravenous and periarticular corticosteroids improved pain control and recovery after TKA with no increase in wound complications up to 1 year.",2020,IVPAS knees showed significantly lower visual analog scale scores from day 1 to 6 weeks (P < .05) and a larger range of movement from day 2 to 4 (P < .05).,"['Total Knee Arthroplasty', 'Forty-six patients (92 TKAs) were included']","['LIA with 40\xa0mg of triamcinolone', 'periarticular corticosteroids', 'dexamethasone', 'intravenous and periarticular steroids (IVPAS', 'Periarticular corticosteroids', 'High-Dose Preoperative and Periarticular Steroid Injection']","['Southampton wound scores and functional knee scores', 'pain control and recovery', 'pain control', 'active straight leg raise earlier', 'wound complications', 'Knee pain, Southampton wound scores, and functional knee scores (Knee Society Knee Score and Oxford Knee Scores', 'visual analog scale scores']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}]","[{'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0422926', 'cui_str': 'Straight leg raise test response'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",,0.234006,IVPAS knees showed significantly lower visual analog scale scores from day 1 to 6 weeks (P < .05) and a larger range of movement from day 2 to 4 (P < .05).,"[{'ForeName': 'Vincent Wai Kwan', 'Initials': 'VWK', 'LastName': 'Chan', 'Affiliation': 'Division of Joint Replacement Surgery, Department of Orthopaedics and Traumatology, The University of Hong Kong, Queen Mary Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Ping Keung', 'Initials': 'PK', 'LastName': 'Chan', 'Affiliation': 'Division of Joint Replacement Surgery, Department of Orthopaedics and Traumatology, The University of Hong Kong, Queen Mary Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Fu', 'Affiliation': 'Division of Joint Replacement Surgery, Department of Orthopaedics and Traumatology, The University of Hong Kong, Queen Mary Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Chi Wing', 'Initials': 'CW', 'LastName': 'Chan', 'Affiliation': 'Department of Anaesthesiology, The University of Hong Kong, Queen Mary Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Chun Hoi', 'Initials': 'CH', 'LastName': 'Yan', 'Affiliation': 'Division of Joint Replacement Surgery, Department of Orthopaedics and Traumatology, The University of Hong Kong, Queen Mary Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Kwong Yuen', 'Initials': 'KY', 'LastName': 'Chiu', 'Affiliation': 'Division of Joint Replacement Surgery, Department of Orthopaedics and Traumatology, The University of Hong Kong, Queen Mary Hospital, Hong Kong SAR, China.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.07.033']
2174,32773325,"Effect and usability of anti-inflammatory drug plasters for knee osteoarthritis: A crossover, double-blind, repeated measures, randomized controlled trial.","BACKGROUND


The use of plasters is a well-accepted treatment with high adherence. However, the characteristics such as its cool feeling or extensibility favored by elderly have a possibility to contribute to clinical utility. The purpose is to examine the effect of anti-inflammatory drug plasters for knee osteoarthritis and the clinical preference of the patients for using plasters. We conducted a crossover, double-blind, randomized controlled trial (RCT) recruited 168 patients with knee osteoarthritis.
METHODS


We included a ""run-in-period"" to evaluate the patients' preference among A (first-generation; methyl salicylate), B (second-generation; indomethacin), and N (base substrate for B) before the crossover sequence of two treatment periods with A and B plasters; four arms (N-A-B, A-A-B, N-B-A, and B-B-A) were made to compare the assessment of A, B, and N plasters. We used two measures: The Japanese Knee Osteoarthritis Measure (JKOM), for clinical functions, and the usability questionnaire to evaluate the clinical value of plasters.
RESULTS


At baseline, there were no significant differences in characteristics. The subjects in groups A and B showed improved overall JKOM scores at the end of each intervention. Comparison of the change of the mean difference showed that A and B were statistically significant improvement over N (-2.40, (95%CI = -3.58 to -1.21), -2.52, (-3.65 to -1.40)) but no significant difference between A and B - 0.13, (-1.14 to 0.89)). In network analysis for usability, twelve items were independent of JKOM's network structure and consisted of two domains. The analysis of usability showed that N and B were preferred over A significantly.
CONCLUSION


Both the first- and second-generation plasters were statistically superior to the base only, but no significant difference between two generations. The patient is surely aware of the effect of the drug itself, but the two feelings are important in the preference.",2020,"Both the first- and second-generation plasters were statistically superior to the base only, but no significant difference between two generations.","['knee osteoarthritis', '168 patients with knee osteoarthritis']","['anti-inflammatory drug plasters', 'A (first-generation; methyl salicylate), B (second-generation; indomethacin']","['overall JKOM scores', 'Japanese Knee Osteoarthritis Measure (JKOM']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0460977', 'cui_str': 'Plasters'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0066282', 'cui_str': 'methyl salicylate'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",168.0,0.102932,"Both the first- and second-generation plasters were statistically superior to the base only, but no significant difference between two generations.","[{'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Tanabe', 'Affiliation': 'Tanabe Orthopaedic Clinic, 3-2-16 Narimasu, Itabashi-ku, Tokyo, 175-0094, Japan. Electronic address: narimasu@mint.ocn.ne.jp.'}, {'ForeName': 'Tokuhide', 'Initials': 'T', 'LastName': 'Doi', 'Affiliation': 'Geriatric Care Facilities Narita Tomisato Tokushu-en, 1-1-1 Hiyoshi-dai, Tomisato-shi, Chiba, 286-0201, Japan. Electronic address: doi@mars.dti.ne.jp.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Akai', 'Affiliation': 'Graduate School, International University of Health and Welfare, 4-1-26 Akasaka, Minato-ku, Tokyo, 107-8402, Japan. Electronic address: akai-masami@iuhw.ac.jp.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Fujino', 'Affiliation': 'Fujino Orthopaedic Clinic, 2-15-12 Johoku, Naka-ku, Hamamatsu-shi, Shizuoka, 432-8011, Japan. Electronic address: keifujino@lily.ocn.ne.jp.'}, {'ForeName': 'Sadao', 'Initials': 'S', 'LastName': 'Arai', 'Affiliation': 'Arai Orthopaedic Clinic, 1-19-7 Asumigaoka Midori-ku, Chiba-shi, Chiba, 267-0066, Japan. Electronic address: ryokusei@fb3.so-net.ne.jp.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Hayashi', 'Affiliation': 'Department of Statistical Epidemiology, School of Health Sciences, Gunma University, 3-39-22 Shouwa-machi, Maebashi-shi, Gunma, 371-8514, Japan. Electronic address: khayashi@health.gunma-u.ac.jp.'}]",Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association,['10.1016/j.jos.2020.04.014']
2175,32773365,Effects of Aerobic Training versus Breathing Exercises on Asthma Control: A Randomized Trial.,"BACKGROUND


Aerobic training and breathing exercises are interventions that improve asthma control. However, the outcomes of these 2 interventions have not been compared.
OBJECTIVE


To compare the effects of aerobic training versus breathing exercises on clinical control (primary outcome), quality of life, exercise capacity, and airway inflammation in outpatients with moderate-to-severe asthma.
METHODS


Fifty-four asthmatics were randomized into either the aerobic training group (AG, n = 29) or the breathing exercise group (BG, n = 25). Both interventions lasted for 24 sessions (2/week, 40 minutes/session). Asthma clinical control (Asthma Control Questionnaire [ACQ]), quality of life (Asthma Quality of Life Questionnaire), asthma symptom-free days (ASFD), airway inflammation, exercise capacity, psychological distress (Hospital Anxiety and Depression Scale), daily-life physical activity (DLPA), and pulmonary function were evaluated before, immediately after, and 3 months after the intervention.
RESULTS


Both interventions presented similar results regarding the ACQ score, psychological distress, ASFD, DLPA, and airway inflammation (P > .05). However, participants in the AG were 2.6 times more likely to experience clinical improvement at the 3-month follow-up than participants in the BG (P = .02). A greater proportion of participants in the AG also presented a reduction in the number of days without rescue medication use compared with BG (34% vs 8%; P = .04).
CONCLUSIONS


Outpatients with moderate-to-severe asthma who participated in aerobic training or breathing exercise programs presented similar results in asthma control, quality of life, asthma symptoms, psychological distress, physical activity, and airway inflammation. However, a greater proportion of participants in the AG presented improvement in asthma control and reduced use of rescue medication.",2020,"Both interventions presented similar results regarding the ACQ score, psychological distress, ASFD, DLPA, and airway inflammation (P > .05).","['Asthma Control', 'Fifty-four asthmatics', 'outpatients with moderate-to-severe asthma', 'Outpatients with moderate-to-severe asthma who participated in']","['Aerobic Training versus Breathing Exercises', 'aerobic training group (AG, n\xa0= 29) or the breathing exercise', 'aerobic training or breathing exercise programs', 'aerobic training versus breathing exercises', 'Aerobic training and breathing exercises']","['asthma control, quality of life, asthma symptoms, psychological distress, physical activity, and airway inflammation', 'ACQ score, psychological distress, ASFD, DLPA, and airway inflammation', 'quality of life, exercise capacity, and airway inflammation', 'asthma control and reduced use of rescue medication', 'Asthma clinical control (Asthma Control Questionnaire [ACQ]), quality of life (Asthma Quality of Life Questionnaire), asthma symptom-free days (ASFD), airway inflammation, exercise capacity, psychological distress (Hospital Anxiety and Depression Scale), daily-life physical activity (DLPA), and pulmonary function']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0436342', 'cui_str': 'Free of symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]",54.0,0.0434033,"Both interventions presented similar results regarding the ACQ score, psychological distress, ASFD, DLPA, and airway inflammation (P > .05).","[{'ForeName': 'Karen B', 'Initials': 'KB', 'LastName': 'Evaristo', 'Affiliation': 'Department of Physical Therapy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Felipe Augusto Rodrigues', 'Initials': 'FAR', 'LastName': 'Mendes', 'Affiliation': 'Department of Physical Therapy, School of Medicine, University of São Paulo, São Paulo, Brazil; Department of Physical Therapy, Universidade Ibirapuera, São Paulo, Brazil.'}, {'ForeName': 'Milene G', 'Initials': 'MG', 'LastName': 'Saccomani', 'Affiliation': 'Department of Physical Therapy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Cukier', 'Affiliation': 'Department of Pulmonary Division (InCor), School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Regina M', 'Initials': 'RM', 'LastName': 'Carvalho-Pinto', 'Affiliation': 'Department of Pulmonary Division (InCor), School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Marcos R', 'Initials': 'MR', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Sports, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Danilo F', 'Initials': 'DF', 'LastName': 'Santaella', 'Affiliation': 'Department of Sports, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Beatriz M', 'Initials': 'BM', 'LastName': 'Saraiva-Romanholo', 'Affiliation': 'Department of Medicine, School of Medicine, University of São Paulo, São Paulo, Brazil; Department of Physical Therapy, University City of Sao Paulo (UNICID), São Paulo, Brazil.'}, {'ForeName': 'Milton A', 'Initials': 'MA', 'LastName': 'Martins', 'Affiliation': 'Department of Sports, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Celso R F', 'Initials': 'CRF', 'LastName': 'Carvalho', 'Affiliation': 'Department of Physical Therapy, School of Medicine, University of São Paulo, São Paulo, Brazil. Electronic address: cscarval@usp.br.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.06.042']
2176,32773366,Study protocol of a RCT of Thrive by Three: A model of intervention and implementation of quality-building and quality-control in childcare centers to strengthen the mental health and development of 1-3-year-olds.,"BACKGROUND


Universal, high-quality childcare offers a unique opportunity to prevent developmental trajectories leading to mental health problems. Yet, growing evidence has shown that the process quality of Norwegian childcare centers varies considerably, and that research-based models for quality building are significantly lacking.
OBJECTIVE


To examine whether a model for quality-building in childcare centers, Thrive by Three, increases the quality of child-caregiver interactions, and promotes child development, well-being and mental health.
METHODS


The Thrive by Three study is a clustered randomized controlled trial involving 187 toddler groups in childcare centers across seven municipalities within southern and central Norway. Each center is randomly allocated to the intervention or waitlist (control) group. Data is collected at four points: pre-intervention (T1), mid-way (T2), post-intervention (T3), one-year post-intervention (T4). Primary outcomes are changes in childcare quality measured by the Classroom Assessment Scoring System (CLASS) toddler version, Student-Teacher Relationship Scale short form (STRS-SF), and Life in Early Childhood Programs (LECP), as well as child development and mental health, measured by The Brief Infant Toddler Social and Emotional Assessment (BITSEA, parent and teacher report), the Caregiver-Teacher Report Form (C-TRF) and Child Behavior Checklist (CBCL, parent report) from the Achenbach ASEBA from 1.5-5 years, and child well-being measured by the Leiden Inventory for Child's Well-Being in Day Care (LICW-D). Secondary outcomes are Child cortisol levels, assessed in a subsample of 372 children.
RESULTS


As of November 2018, a total of 1531 children and 769 staff, from 187 toddler-groups were recruited. The recruitment of staff will be ongoing until May 2020, due to turnover. As of January 2020, the intervention group has been working with Thrive by Three for 1.5 years. Data at T1, T2 and T3 from both the intervention and control group has been completed and T4 will be completed in June 2020.
CONCLUSIONS


The present study makes an important contribution to the field of quality-building in childcare centers. The results will provide greater insight into how high quality can be obtained and the effects of high-quality early childcare on child mental health. This in turn will be significant for policymakers and to the Norwegian society at large.
CLINICALTRIAL


Clinical Trials NCT03879733, Registered on March 25, 2019.",2020,"Data at T1, T2 and T3 from both the intervention and control group has been completed and T4 will be completed in June 2020.
","['187 toddler groups in childcare centers across seven municipalities within southern and central Norway', 'childcare centers', 'As of November 2018, a total of 1531 children and 769 staff, from 187 toddler-groups were recruited']",['intervention or waitlist (control) group'],"[""changes in childcare quality measured by the Classroom Assessment Scoring System (CLASS) toddler version, Student-Teacher Relationship Scale short form (STRS-SF), and Life in Early Childhood Programs (LECP), as well as child development and mental health, measured by The Brief Infant Toddler Social and Emotional Assessment (BITSEA, parent and teacher report), the Caregiver-Teacher Report Form (C-TRF) and Child Behavior Checklist (CBCL, parent report) from the Achenbach ASEBA from 1.5-5 years, and child well-being measured by the Leiden Inventory for Child's Well-Being in Day Care (LICW-D"", 'Child cortisol levels']","[{'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008093', 'cui_str': 'Child Well Being'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0011017', 'cui_str': 'Day Care'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]",1531.0,0.0912925,"Data at T1, T2 and T3 from both the intervention and control group has been completed and T4 will be completed in June 2020.
","[{'ForeName': 'Ratib', 'Initials': 'R', 'LastName': 'Lekhal', 'Affiliation': 'Department of Communication and Culture, Norwegian Business School, Oslo, NO.'}, {'ForeName': 'May Britt', 'Initials': 'MB', 'LastName': 'Drugli', 'Affiliation': 'The Regional Centre for Child and Youth Mental Health and Child Welfare - Central Norway Norwegian University of Science and Technology (NTNU)Trondheim Norway, Trondheim, NO.'}, {'ForeName': 'Turid Suzanne', 'Initials': 'TS', 'LastName': 'Berg-Nielsen', 'Affiliation': 'Regional Centre for Child and Adolescent Mental Health Eastern and Southern Norway, Oslo, NO.'}, {'ForeName': 'Elisabet Solheim', 'Initials': 'ES', 'LastName': 'Buøen', 'Affiliation': 'Regional Centre for Child and Adolescent Mental Health Eastern and Southern Norway, Oslo, NO.'}]",JMIR research protocols,['10.2196/17726']
2177,32773375,"Communicating Uncertainty in Written Consumer Health Information to the Public: Parallel-Group, Web-Based Randomized Controlled Trial.","BACKGROUND


Uncertainty is integral to evidence-informed decision making and is of particular importance for preference-sensitive decisions. Communicating uncertainty to patients and the public has long been identified as a goal in the informed and shared decision-making movement. Despite this, there is little quantitative research on how uncertainty in health information is perceived by readers.
OBJECTIVE


The aim of this study was to examine the impact of different uncertainty descriptions regarding the evidence for a treatment effect in a written research summary for the public.
METHODS


We developed 8 versions of a research summary on a fictitious drug for tinnitus with varying degrees (Q1), sources (Q2), and magnitudes of uncertainty (Q3). We recruited 2099 members of the German public from a web-based research panel. Of these, 1727 fulfilled the inclusion criteria and were randomly presented with one of these research summaries. Randomization was conducted by using a centralized computer with a random number generator. Web-based recruitment and data collection were fully automated. Participants were not aware of the purpose of the study and alternative presentations. We measured the following outcomes: perception of the treatment effectiveness (primary), certainty in the judgement of treatment effectiveness, perception of the body of evidence, text quality, and intended decision. The outcomes were self-assessed.
RESULTS


For the primary outcome, we did not find a global effect for Q1 and Q2 (P=.25 and P=.73), but we found a global effect for Q3 (P=.048). Pairwise comparisons showed a weaker perception of treatment effectiveness for the research summary with 3 sources of uncertainty compared to the version with 2 sources of uncertainty (P=.04). Specifically, the proportion of the participants in the group with 3 sources of uncertainty that perceived the drug as possibly beneficial was 9% lower than that of the participants in the group with 2 sources of uncertainty (92/195, 47.2% vs 111/197, 56.3%, respectively). The proportion of the participants in the group with 3 sources of uncertainty that considered the drug to be of unclear benefit was 8% higher than that of the participants in the group with 2 sources of uncertainty (72/195, 36.9% vs 57/197, 28.9%, respectively). However, there was no significant difference compared to the version with 1 source of uncertainty (P=.31). We did not find any meaningful differences between the research summaries for the secondary outcomes.
CONCLUSIONS


Communicating even a large magnitude of uncertainty for a treatment effect had little impact on the perceived effectiveness. Efforts to improve public understanding of research are needed to improve the understanding of evidence-based health information.
TRIAL REGISTRATION


German Clinical Trials Register DRKS00015911, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015911.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/13425.",2020,"For the primary outcome, we did not find a global effect for Q1 and Q2 (P=.25 and P=.73), but we found a global effect for Q3 (P=.048).","['We recruited 2099 members of the German public from a web-based research panel', '1727 fulfilled the inclusion criteria and were randomly presented with one of these research summaries']",[],"['tinnitus with varying degrees (Q1), sources (Q2), and magnitudes of uncertainty (Q3', 'global effect for Q3', 'global effect for Q1 and Q2']","[{'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0150312', 'cui_str': 'Present'}]",[],"[{'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.132533,"For the primary outcome, we did not find a global effect for Q1 and Q2 (P=.25 and P=.73), but we found a global effect for Q3 (P=.048).","[{'ForeName': 'Roland B', 'Initials': 'RB', 'LastName': 'Büchter', 'Affiliation': 'Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Betsch', 'Affiliation': 'Media and Communication Science, University of Erfurt, Erfurt, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Ehrlich', 'Affiliation': 'Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Fechtelpeter', 'Affiliation': 'Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Grouven', 'Affiliation': 'Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Keller', 'Affiliation': 'Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Meuer', 'Affiliation': 'Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany.'}, {'ForeName': 'Constanze', 'Initials': 'C', 'LastName': 'Rossmann', 'Affiliation': 'Media and Communication Science, University of Erfurt, Erfurt, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Waltering', 'Affiliation': 'Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany.'}]",Journal of medical Internet research,['10.2196/15899']
2178,32773376,An Employment Intervention Program (Work2Prevent) for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 2): Protocol for a Single-Arm Mixed Methods Pilot Test to Assess Feasibility and Acceptability.,"BACKGROUND


Young cisgender men who have sex with men (YMSM), young transgender women (YTW), and gender nonconforming (GNC) youth of color face substantial economic and health disparities. In particular, HIV risk and infection among these groups remains a significant public health issue. In 2017, 17% of all new HIV diagnoses were attributed to male-to-male sexual contact among adolescents and young adults aged 13 to 24 years. However, such disparities cannot be attributed to individual-level factors alone but rather are situated within larger social and structural contexts that marginalize and predispose YMSM, YTW, and GNC youth of color to increased HIV exposure. Addressing social and structural risk factors requires intervention on distal drivers of HIV risk, including employment and economic stability. The Work2Prevent (W2P) study aims to target economic stability through job readiness and employment as a structural-level intervention for preventing adolescent and young adult HIV among black and Latinx YMSM, YTW, and GNC youth. This study seeks to assess intervention feasibility and acceptability in the target populations and determine preliminary efficacy of the intervention to increase employment and reduce sexual risk behaviors.
OBJECTIVE


The goal of the research is to pilot-test a tailored, theoretically informed employment intervention program among YMSM, YTW, and GNC youth of color. This intervention was adapted from Increased Individual Income and Independence, an existing evidence-based employment program for HIV-positive adults during phase 1 of the W2P study.
METHODS


The employment intervention will be pilot-tested among vulnerable YMSM, YTW, and GNC youth of color in a single-arm pre-post trial to assess feasibility, acceptability, and preliminary estimates of efficacy.
RESULTS


Research activities began in March 2018 and were completed in November 2019. Overall, 5 participants were enrolled in the pretest and 51 participants were enrolled in the pilot.
CONCLUSIONS


Interventions that address the social and structural drivers of HIV exposure and infection are sorely needed in order to successfully bend the curve in the adolescent and young adult HIV epidemic. Employment as prevention has the potential to be a scalable intervention that can be deployed among this group.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03313310; https://clinicaltrials.gov/ct2/show/NCT03313310.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/16401.",2020,"This study seeks to assess intervention feasibility and acceptability in the target populations and determine preliminary efficacy of the intervention to increase employment and reduce sexual risk behaviors.
","['In 2017, 17% of all new HIV diagnoses were attributed to male-to-male sexual contact among adolescents and young adults aged 13 to 24 years', 'Young Men', 'Men and Transgender Youth of Color (Phase 2', 'Young cisgender men who have sex with men (YMSM), young transgender women (YTW), and gender nonconforming (GNC) youth of color face substantial economic and health disparities', '5 participants were enrolled in the pretest and 51 participants were enrolled in the pilot', 'adolescent and young adult HIV among black and Latinx YMSM, YTW, and GNC youth']","['Employment Intervention Program (Work2Prevent', 'job readiness and employment as a structural-level intervention']",['Feasibility and Acceptability'],"[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0474425', 'cui_str': 'Color of face'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",5.0,0.0430063,"This study seeks to assess intervention feasibility and acceptability in the target populations and determine preliminary efficacy of the intervention to increase employment and reduce sexual risk behaviors.
","[{'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Hill', 'Affiliation': 'Planned Parenthood Great Plains, Overland Park, KS, United States.'}, {'ForeName': 'Darnell N', 'Initials': 'DN', 'LastName': 'Motley', 'Affiliation': 'Center for Interdisciplinary Inquiry and Innovation in Sexual and Reproductive Health, Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL, United States.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Rosentel', 'Affiliation': 'Center for Interdisciplinary Inquiry and Innovation in Sexual and Reproductive Health, Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL, United States.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'VandeVusse', 'Affiliation': 'Guttmacher Institute, New York City, NY, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Garofalo', 'Affiliation': ""Division of Adolescent Medicine, Ann & Robert H Lurie Children's Hospital, Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Schneider', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL, United States.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Kuhns', 'Affiliation': ""Division of Adolescent Medicine, Ann & Robert H Lurie Children's Hospital, Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.""}, {'ForeName': 'Michele D', 'Initials': 'MD', 'LastName': 'Kipke', 'Affiliation': ""Division of Research on Children, Youth, and Families, Children's Hospital Los Angeles, Los Angeles, CA, United States.""}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Reisner', 'Affiliation': 'Fenway Health, The Fenway Institute, Boston, MA, United States.'}, {'ForeName': 'Betty M', 'Initials': 'BM', 'LastName': 'Rupp', 'Affiliation': 'Collaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sanchez', 'Affiliation': 'Collaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Micah', 'Initials': 'M', 'LastName': 'McCumber', 'Affiliation': 'Collaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Renshaw', 'Affiliation': 'Collaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'West Goolsby', 'Affiliation': 'Collaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Matthew Shane', 'Initials': 'MS', 'LastName': 'Loop', 'Affiliation': 'Collaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}]",JMIR research protocols,['10.2196/16401']
2179,32773377,#BlackBreastsMatter: Process Evaluation of Recruitment and Engagement of Pregnant African American Women for a Social Media Intervention Study to Increase Breastfeeding.,"BACKGROUND


In the United States, there are lower rates of breastfeeding among African American mothers, particularly those who are younger women. Recent epidemiological studies have shown a strong association of more aggressive types of breast cancer (estrogen receptor negative) among African American women, with a higher risk in African American women who did not breastfeed their children.
OBJECTIVE


This study aims to describe the process evaluation of recruitment and educational strategies to engage pregnant African American participants for a pilot study designed to determine whether social media messaging about breast cancer risk reduction through breastfeeding may positively influence breastfeeding rates.
METHODS


This pilot study is conducted in collaboration with a local Women, Infants, and Children (WIC) organization and hospital and prenatal clinics of a local health care network. To engage African American women to enroll in the study, several methods and monitoring processes were explored, including WIC electronic text-based messages sent out to all phones of current WIC recipients (referred to as e-blasts); keyword responses to texts from flyers and posters in local community-based organizations, hospitals, and prenatal clinics; keyword responses using electronic links posted in established Facebook groups; and snowball recruitment of other pregnant women by current participants through Facebook. Once enrolled, participants were randomized to 2 study conditions: (1) an intervention group receiving messages about breast cancer risk reduction and breastfeeding or (2) a control group receiving breastfeeding-only messages. Data were obtained through electronic monitoring, SurveyMonkey, qualitative responses on Facebook, focus groups, and interviews.
RESULTS


More than 3000 text messages were sent and received through WIC e-blasts and keyword responses from flyers. A total of 472 women were recruited through WIC e-blast, and 161 responded to flyers and contacts through the local health care network, community-based organizations, Facebook, and friend referrals. A total of 633 women were assessed for eligibility to participate in the study. A total of 288 pregnant African American women were enrolled, consented, and completed presurvey assessments (102.8% of the goal), and 22 participants attended focus groups or interviews reporting on their experiences with Facebook and the educational messages.
CONCLUSIONS


This process evaluation suggests that using electronic, smartphone apps with social media holds promise for both recruitment and conduct of health education intervention studies for pregnant African American women. Providing messaging and resources through social media to reinforce and educate women about breastfeeding and potentially provide lactation support is intriguing. Convenience (for researchers and participants) is an attribute of social media for this demographic of women and worthy of further research as an educational tool.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03680235; https://clinicaltrials.gov/ct2/show/NCT03680235.",2020,"This process evaluation suggests that using electronic, smartphone apps with social media holds promise for both recruitment and conduct of health education intervention studies for pregnant African American women.","['A total of 633 women were assessed for eligibility to participate in the study', '288 pregnant African American women were enrolled, consented, and completed presurvey assessments (102.8% of the goal), and 22 participants attended focus groups or interviews reporting on their experiences with', 'African American mothers, particularly those who are younger women', 'pregnant African American women', 'Pregnant African American Women', 'African American women, with a higher risk in African American women who did not breastfeed their children', 'collaboration with a local Women, Infants, and Children (WIC) organization and hospital and prenatal clinics of a local health care network', 'A total of 472 women were recruited through WIC e-blast, and 161 responded to flyers and contacts through the local health care network, community-based organizations, Facebook, and friend referrals', 'engage pregnant African American participants']","['Facebook and the educational messages', 'social media messaging', 'BlackBreastsMatter', 'intervention group receiving messages about breast cancer risk reduction and breastfeeding or (2) a control group receiving breastfeeding-only messages']",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0337026', 'cui_str': 'Blast'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]","[{'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],472.0,0.0689026,"This process evaluation suggests that using electronic, smartphone apps with social media holds promise for both recruitment and conduct of health education intervention studies for pregnant African American women.","[{'ForeName': 'Cassy', 'Initials': 'C', 'LastName': 'Dauphin', 'Affiliation': 'Cancer Prevention and Control, Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States.'}, {'ForeName': 'Nikia', 'Initials': 'N', 'LastName': 'Clark', 'Affiliation': 'Cancer Prevention and Control, Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Cadzow', 'Affiliation': ""Department of Health Services Administration, D'Youville College, Buffalo, NY, United States.""}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Saad-Harfouche', 'Affiliation': 'Cancer Prevention and Control, Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Rodriguez', 'Affiliation': 'Cancer Prevention and Control, Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Glaser', 'Affiliation': 'Cancer Prevention and Control, Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Kiviniemi', 'Affiliation': 'Department of Health, Behavior and Society, University of Kentucky, Lexington, KY, United States.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Keller', 'Affiliation': 'Department of Community Health and Health Behavior, State University of New York at Buffalo, Buffalo, NY, United States.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Erwin', 'Affiliation': 'Cancer Prevention and Control, Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States.'}]",Journal of medical Internet research,['10.2196/16239']
2180,32780844,Physical activity in children at risk of postthrombotic sequelae: a pilot randomized controlled trial.,"Increased physical activity is protective against worsening of postthrombotic syndrome (PTS) in adults. We assessed patient eligibility, consent, adherence, and retention rates in a pilot trial of prescribed physical activity following venous thromboembolism (VTE) in children. Secondary objectives were to describe the within-subject changes in PTS, quality of life, and coagulation biomarkers before and after the intervention in each group. We enrolled and randomized patients between 7 and 21 years of age to the physical activity group or the standard care (education-only) group in a 1:1 allocation ratio. The physical activity group wore a Fitbit for 4 weeks to determine habitual activity and then increased activity over an 8-week ""active"" period, followed by a 4-week ""do-as-you-wish"" period. Two hundred thirty-five children were diagnosed with VTE; 111 patients were screened, of whom 40 (36%) met study eligibility criteria. Of these, 23 (57%) consented to participate and were randomized (Fitbit,11; standard group, 12). The trial was of greater interest to overweight and obese children, as they comprised 83% of consented patients. Only 33% adhered to the activity prescription, and 65% (15/23) completed the trial. The PTS scores (P = .001) improved in the physical activity group compared with the education-only group. It is feasible to enroll and randomize pediatric VTE patients to a prescribed physical activity regimen 3 months following VTE. Metrics for adherence to enhanced physical activity and retention were not met. These results provide the rationale to explore low adherence and retention rates before moving forward with a larger trial of exercise training following VTE. This trial was registered at www.clinicaltrials.gov as #NCT03075761.",2020,The PTS scores (P = .001) improved in the physical activity group compared with the education-only group.,"['randomized patients between 7 and 21 years of age to the physical activity group or the standard care (education-only) group in a 1:1 allocation ratio', 'children', 'Two hundred thirty-five children were diagnosed with VTE; 111 patients were screened, of whom 40 (36%) met study eligibility criteria', 'postthrombotic syndrome (PTS) in adults', 'children at risk of postthrombotic sequelae']",[],"['Physical activity', 'PTS, quality of life, and coagulation biomarkers', 'PTS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0032807', 'cui_str': 'Postthrombotic syndrome'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0425119', 'cui_str': 'Child at risk'}, {'cui': 'C0243088', 'cui_str': 'sequels'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032807', 'cui_str': 'Postthrombotic syndrome'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",235.0,0.106153,The PTS scores (P = .001) improved in the physical activity group compared with the education-only group.,"[{'ForeName': 'Rida', 'Initials': 'R', 'LastName': 'Hasan', 'Affiliation': 'Division of Hematology/Oncology, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hanna', 'Affiliation': 'Division of Hematology/Oncology, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Population and Data Sciences and.'}, {'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Malone', 'Affiliation': ""Department of Pediatrics, Children's Medical Center, Dallas, TX.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Tong', 'Affiliation': 'Division of Hematology/Oncology, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Niavana', 'Initials': 'N', 'LastName': 'Salas', 'Affiliation': ""Department of Pediatrics, Children's Medical Center, Dallas, TX.""}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Sarode', 'Affiliation': 'Department of Pathology, University of Texas Southwestern Medical Center, Dallas, TX; and.'}, {'ForeName': 'Janna', 'Initials': 'J', 'LastName': 'Journeycake', 'Affiliation': 'Division of Hematology/Oncology, Department of Pediatrics, University of Oklahoma College of Medicine, Oklahoma City, OK.'}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Zia', 'Affiliation': 'Division of Hematology/Oncology, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX.'}]",Blood advances,['10.1182/bloodadvances.2020002096']
2181,32780921,Effects of Monitor Alarm Management Training on Nurses' Alarm Fatigue: A Randomized Controlled Trial.,"BACKGROUND


Chaotic monitor alarm management generate a large number of alarms, which result in alarm fatigue. ICU nurses are caretakers of critically ill patients, the effect of alarm management affect patient safety directly.
OBJECTIVES


To evaluate the effect of monitor alarm management training based on the theory of planned behavior for reducing alarm fatigue in intensive care unit nurses.
DESIGN


A randomized, single-blind trial. This article follows the requirements of CONSORT statement.
PARTICIPANTS


The study was conducted from February 2019 to May 2019 in a tertiary A-level hospital. 93 ICU clinical nurses were included, and they were randomly assigned into two groups.
INTERVENTION


Nurses in the experimental group (n = 47) received a 12-week alarm management training course based on the theory of planned behavior. Nurses in the control group (n = 46) received regular training. All nurses' alarm fatigue scores were measured with a questionnaire before and after the study period. Total number of alarms, nonactionable alarms and true crisis alarms was recorded continuously throughout the study period.
RESULTS


For baseline comparisons, no significant differences were found. By the analysis of independent samples one-way ANCOVAs, the nurses' adjusted alarm fatigue scores at the posttest in the experimental group was significantly lower than those in the control group (p < 0.001). After the study period, adjusted total number of alarms and nonactionable alarms recorded in the experimental group were both significantly lower than those recorded in the control group (p < 0.001). After the study period, no significant difference between the two groups was noted in the adjusted number of true crisis alarms (p > 0.05). The interventions did not cause adverse events in either group of patients and did not cause adverse events in patients.
CONCLUSION


ICU nurses' alarm fatigue were effectively decreased by the monitor alarm management training based on the theory of planned behavior.
RELEVANCE TO CLINICAL PRACTICE


1. Monitor alarm training based on the theory of planned behavior is effective in reducing nonactionable alarms and lowering alarm fatigue in ICU nurses. 2. The intervention considering the social psychological aspects of behavior, is effective in rebuilding the nurses' awareness and behavior of alarm management. 3. In the process of improving alarm management, nonactionable alarms can be effectively reduced by giving nurses more training resources and improving their knowledge and awareness of alarm management. 4. Nurses are the direct users of monitoring technology, Hospital administrators should attach importance to the role of nurses in the medical monitoring system. We suggest that nursing managers implement training programs in more ICUs in the future to improve alarm management ability and lower alarm fatigue in ICU nurses.",2020,Monitor alarm training based on the theory of planned behavior is effective in reducing nonactionable alarms and lowering alarm fatigue in ICU nurses.,"[""Nurses' Alarm Fatigue"", 'ICU nurses are caretakers of critically ill patients', 'The study was conducted from February 2019 to May 2019 in a tertiary A-level hospital', 'Nurses in the experimental group (n = 47', 'intensive care unit nurses', '93 ICU clinical nurses']","['regular training', 'monitor alarm management training', '12-week alarm management training course', 'Monitor Alarm Management Training']","['alarm fatigue scores', 'adjusted number of true crisis alarms', 'Total number of alarms, nonactionable alarms and true crisis alarms', 'adjusted total number of alarms and nonactionable alarms', 'alarm fatigue', ""All nurses' alarm fatigue scores""]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0336648', 'cui_str': 'Alarm'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0335350', 'cui_str': 'Building caretaker'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0336648', 'cui_str': 'Alarm'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0336648', 'cui_str': 'Alarm'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]",,0.0284062,Monitor alarm training based on the theory of planned behavior is effective in reducing nonactionable alarms and lowering alarm fatigue in ICU nurses.,"[{'ForeName': 'Jiasi', 'Initials': 'J', 'LastName': 'Bi', 'Affiliation': 'Nursing Department, the First Bethune Hospital of Jilin University, Changchun City, Jilin province, China, 130021.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yin', 'Affiliation': 'Nursing Department, the First Bethune Hospital of Jilin University, Changchun City, Jilin province, China, 130021.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Nursing Department, the First Bethune Hospital of Jilin University, Changchun City, Jilin province, China, 130021.'}, {'ForeName': 'Ruitong', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': 'Nursing School of Jilin University, Changchun City, Jilin province, China, 130021.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Gastric Department, the First Bethune Hospital of Jilin University, Changchun City, Jilin province, China, 130021.'}, {'ForeName': 'Tangsheng', 'Initials': 'T', 'LastName': 'Zhong', 'Affiliation': 'Nursing Department, the First Bethune Hospital of Jilin University, Changchun City, Jilin province, China, 130021.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zan', 'Affiliation': 'Intensive Care Unit, the First Bethune Hospital of Jilin University, Changchun City, Jilin province, China, 130021.'}, {'ForeName': 'Baoxing', 'Initials': 'B', 'LastName': 'Guan', 'Affiliation': 'Intensive Care Unit, the First Bethune Hospital of Jilin University, Changchun City, Jilin province, China, 130021.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Nursing Department, the First Bethune Hospital of Jilin University, Changchun City, Jilin province, China, 130021.'}]",Journal of clinical nursing,['10.1111/jocn.15452']
2182,32780926,Effects of intraoperative dexmedetomidine on the incidence of acute kidney injuryin pediatric cardiac surgery patients: A randomized controlled trial.,"BACKGROUND


Perioperative dexmedetomidineuse has been reported to reduce the incidence of postoperative acute kidney injuryafter adult cardiac surgery. However, large-scale randomized controlled trials evaluating the effect of dexmedetomidine use on acute kidney injury in pediatric patients are lacking.
AIMS


We investigated whether intraoperativedexmedetomidine could reduce the incidence of acute kidney injury in pediatric cardiac surgery patients.
METHODS


In total, 141 pediatric patients were randomly assigned to dexmedetomidine or control groups. After anesthetic induction, patients in the dexmedetomidine group were administered 1 µg/kg of dexmedetomidine over 10 minutes, and an additional 0.5 µg/kg/hof dexmedetomidine during surgery. Additionally, 1 µg/kg of dexmedetomidine was infused immediately after cardiopulmonary bypass was initiated. The incidence of acute kidney injurywas defined following Kidney Disease Improving Global Outcomes guidelines.
RESULTS


The final analysis included 139 patients. The incidence of acute kidney injury did not differ between dexmedetomidine and control groups (16.9% vs. 23.5%; odds ratio 0.661; 95% CI 0.285 to 1.525; p = 0.33). Similarly,neither the incidence of abnormal postoperative estimated glomerular filtration ratevalues (P = 0.96) differed between the two groups, northe incidence of arrhythmia, mechanical ventilation duration, length of stay in the intensive care unit,and hospitalization.
CONCLUSIONS


Intraoperative dexmedetomidine did not reduce acute kidney injuryincidence in pediatric cardiac surgery patients.",2020,The incidence of acute kidney injury did not differ between dexmedetomidine and control groups (16.9% vs. 23.5%; odds ratio 0.661; 95% CI 0.285 to 1.525; p = 0.33).,"['141 pediatric patients', 'pediatric patients', 'pediatric cardiac surgery patients', 'acute kidney injuryin pediatric cardiac surgery patients', '139 patients']","['intraoperativedexmedetomidine', 'dexmedetomidine', 'intraoperative dexmedetomidine']","['acute kidney injuryincidence', 'incidence of abnormal postoperative estimated glomerular filtration ratevalues', 'northe incidence of arrhythmia, mechanical ventilation duration, length of stay in the intensive care unit,and hospitalization', 'incidence of acute kidney injury']","[{'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C5191072', 'cui_str': '139'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0232809', 'cui_str': 'Glomerular filtration'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}]",141.0,0.5822,The incidence of acute kidney injury did not differ between dexmedetomidine and control groups (16.9% vs. 23.5%; odds ratio 0.661; 95% CI 0.285 to 1.525; p = 0.33).,"[{'ForeName': 'Eun-Hee', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Seoul National University Hospital, Seoul National University College of Medicine, #101 Daehak-ro, Jongno-GU, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Seoul National University Hospital, Seoul National University College of Medicine, #101 Daehak-ro, Jongno-GU, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Hee-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Seoul National University Hospital, Seoul National University College of Medicine, #101 Daehak-ro, Jongno-GU, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Young-Eun', 'Initials': 'YE', 'LastName': 'Jang', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Seoul National University Hospital, Seoul National University College of Medicine, #101 Daehak-ro, Jongno-GU, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Sang-Hwan', 'Initials': 'SH', 'LastName': 'Ji', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Seoul National University Hospital, Seoul National University College of Medicine, #101 Daehak-ro, Jongno-GU, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Woong-Han', 'Initials': 'WH', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiothoracic surgery, Seoul National University Hospital, Seoul National University College of Medicine, #101 Daehak-ro, Jongno-GU, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Jae Gun', 'Initials': 'JG', 'LastName': 'Kwak', 'Affiliation': 'Department of Cardiothoracic surgery, Seoul National University Hospital, Seoul National University College of Medicine, #101 Daehak-ro, Jongno-GU, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Jin-Tae', 'Initials': 'JT', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Seoul National University Hospital, Seoul National University College of Medicine, #101 Daehak-ro, Jongno-GU, Seoul, 03080, Republic of Korea.'}]",Paediatric anaesthesia,['10.1111/pan.13995']
2183,32780935,Pulsatile and steady-state 24-hour hemodynamics in adolescents and young adults: The next steps ahead.,,2020,,['adolescents and young adults'],[],['Pulsatile and steady-state 24-hour hemodynamics'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]",[],"[{'cui': 'C0439606', 'cui_str': 'Pulsatile'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]",,0.0142046,,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Weber', 'Affiliation': 'Cardiology Department, Klinikum Wels-Grieskirchen, Wels, Austria.'}, {'ForeName': 'Athanasios D', 'Initials': 'AD', 'LastName': 'Protogerou', 'Affiliation': 'Cardiovascular Prevention and Research Unit, Clinic-Laboratory of Pathophysiology, Laiko Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Sharman', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Siegfried', 'Initials': 'S', 'LastName': 'Wassertheurer', 'Affiliation': 'Austrian Institute of Technology, Vienna, Austria.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13969']
2184,32780949,What to Expect When Switching to a Second Antidepressant Medication Following an Ineffective Initial SSRI: A Report From the Randomized Clinical STAR*D Study.,"OBJECTIVE


An antidepressant medication switch often follows a failed initial trial with selective serotonin reuptake inhibitors (SSRIs). When, for whom, and how often second-step response and remission occur are unclear, as is preferred second-step trial duration. As more treatments are approved for use following 2 failed ""adequate"" trials, researchers and clinicians require an evidence-based definition of ""adequate.""
METHODS


Following citalopram in the randomized Sequenced Treatment Alternatives to Relieve Depression (STAR*D) clinical trial (which ran July 2001-September 2006), participants with score ≥ 11 on the 16-item Quick Inventory of Depressive Symptomatology-Self-Rated (QIDS-SR₁₆) were randomized to bupropion sustained release, sertraline, or venlafaxine extended release (up to 14 weeks). The QIDS-SR₁₆ defined response, remission, and no clinically meaningful benefit based on the modified intent-to-treat sample.
RESULTS


About 80% of 438 participants completed ≥ 6 weeks of treatment with the switch medication. All treatments had comparable outcomes. Overall, 21% (91/438) remitted, 9% (40/438) responded without remission, and 58% (255/438) had no meaningful benefit. Half of the responses and two-thirds of remissions occurred after 6 weeks of treatment. Overall, 33% of responses (43/131) occurred after ≥ 9 weeks of treatment. No baseline features differentiated early from later responders or remitters. No early triage point was found, but those with at least 20% reduction from baseline in QIDS-SR₁₆ score around week 2 were 6 times more likely to respond or remit than those without this reduction.
CONCLUSIONS


Following nonefficacy with an initial SSRI, only about 20% remit and more than half achieve no meaningful benefit with a second-step switch to another monoaminergic antidepressant. A 12-week trial duration seems necessary to capture as many second-step switch responders as possible.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT00021528.",2020,"No early triage point was found, but those with at least 20% reduction from baseline in QIDS-SR₁₆ score around week 2 were 6 times more likely to respond or remit than those without this reduction.
",['participants with score ≥ 11 on the 16-item Quick Inventory of Depressive Symptomatology-Self-Rated (QIDS-SR₁₆'],"['bupropion sustained release, sertraline, or venlafaxine', 'citalopram', 'selective serotonin reuptake inhibitors (SSRIs']",['QIDS-SR₁₆ score'],"[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}]","[{'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0895863,"No early triage point was found, but those with at least 20% reduction from baseline in QIDS-SR₁₆ score around week 2 were 6 times more likely to respond or remit than those without this reduction.
","[{'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Rush', 'Affiliation': 'Duke-National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'South', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Shailesh Bobby', 'Initials': 'SB', 'LastName': 'Jain', 'Affiliation': 'Department of Psychiatry, Texas Tech University Health Sciences Center, Odessa, Texas, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390-9119. madhukar.trivedi@utsouthwestern.edu.'}]",The Journal of clinical psychiatry,['10.4088/JCP.19m12949']
2185,32781086,"Efficacy and Safety of Aldafermin, an Engineered FGF19 Analog, in a Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Nonalcoholic Steatohepatitis.","BACKGROUND AND AIMS


Aldafermin, an engineered analog of FGF19, inhibits bile acid synthesis and regulates metabolic homeostasis. We report results from a 24-week, phase 2 study, with serial liver biopsies, of patients with non-alcoholic steatohepatitis (NASH).
METHODS


We performed a double-blind study of 78 patients with NASH at 9 centers in the United States. Key inclusion criteria were biopsy-proven NASH with non-alcoholic fatty liver disease activity score (NAS) ≥4, stage 2 or 3 fibrosis by NASH Clinical Research Network classification, and absolute liver fat content (LFC) ≥8%, measured by magnetic resonance imaging-proton density fat fraction. Patients were randomly assigned (1:2) to groups given subcutaneous placebo (n=25) or aldafermin 1 mg (n=53) daily for 24 weeks. The primary outcome was change in absolute LFC from baseline at week 24. Secondary outcomes included serum markers and histological measures of fibrosis improvement and NASH resolution.
RESULTS


At week 24, the aldafermin group had a significant reduction in absolute LFC (reduction of 7.7%) compared with placebo (reduction of 2.7%; difference, reduction of 5.0%; 95% CI, reduction of 8.0%-1.9%; P = .002). Aldafermin produced significantly greater decreases in levels of 7alpha-hydroxy-4-cholesten-3-one, bile acids, alanine and aspartate aminotransferases, and Pro-C3 than placebo. Fibrosis improvement (≥1 stage) with no worsening of NASH was achieved in 38% of patients receiving aldafermin vs 18% of patients receiving placebo (P = .10). NASH resolution with no worsening of fibrosis was observed in 24% of patients given aldafermin vs 9% of patients given placebo (P = .20). Discontinuations due to adverse events occurred in no patients in the aldafermin group and 4% of patients in the placebo group.
CONCLUSIONS


In a phase 2 trial of patients with NASH, aldafermin reduced liver fat and produced a trend toward fibrosis improvement. ClinicalTrials.gov no: NCT02443116.",2020,"Aldafermin produced significantly greater decreases in levels of 7alpha-hydroxy-4-cholesten-3-one, bile acids, alanine and aspartate aminotransferases, and Pro-C3 than placebo.","['78 patients with NASH at 9 centers in the United States', 'patients with non-alcoholic steatohepatitis (NASH', 'Key inclusion criteria were biopsy-proven NASH with non-alcoholic fatty liver disease activity score (NAS) ≥4, stage 2 or 3 fibrosis by NASH Clinical Research Network classification, and absolute liver fat content (LFC', 'Patients With Nonalcoholic Steatohepatitis']","['aldafermin', 'Placebo', 'Aldafermin', 'subcutaneous placebo', 'placebo']","['Discontinuations due to adverse events', 'levels of 7alpha-hydroxy-4-cholesten-3-one, bile acids, alanine and aspartate aminotransferases, and Pro-C3', 'change in absolute LFC', 'NASH resolution with no worsening of fibrosis', 'absolute LFC', 'serum markers and histological measures of fibrosis improvement and NASH resolution', 'Fibrosis improvement (≥1 stage) with no worsening of NASH']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0049730', 'cui_str': '7 alpha-hydroxy-4-cholesten-3-one'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0071997', 'cui_str': 'Pro-Complement 3'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0162491', 'cui_str': 'Marker, Serum'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",78.0,0.570415,"Aldafermin produced significantly greater decreases in levels of 7alpha-hydroxy-4-cholesten-3-one, bile acids, alanine and aspartate aminotransferases, and Pro-C3 than placebo.","[{'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'Radcliffe Department of Medicine, University of Oxford, United Kingdom; Pinnacle Clinical Research, San Antonio, TX, United States. Electronic address: stephenharrison87@gmail.com.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Neff', 'Affiliation': 'Covenant Research, Sarasota, FL, United States.'}, {'ForeName': 'Cynthia D', 'Initials': 'CD', 'LastName': 'Guy', 'Affiliation': 'Pathology, Duke University, Durham, NC, United States.'}, {'ForeName': 'Mustafa R', 'Initials': 'MR', 'LastName': 'Bashir', 'Affiliation': 'Radiology and Medicine (Gastroenterology), Duke University, Durham, NC, United States.'}, {'ForeName': 'Angelo H', 'Initials': 'AH', 'LastName': 'Paredes', 'Affiliation': 'San Antonio Military Medical Center, San Antonio, TX, United States.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Frias', 'Affiliation': 'National Research Institute, Los Angeles, CA, United States.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Younes', 'Affiliation': 'Gastro One Research, Germantown, TN, United States.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Trotter', 'Affiliation': 'Clinical Research and Education, Texas Digestive Disease Consultants, Dallas, TX, United States.'}, {'ForeName': 'Nadege T', 'Initials': 'NT', 'LastName': 'Gunn', 'Affiliation': 'Pinnacle Clinical Research, Austin, TX, United States.'}, {'ForeName': 'Sam E', 'Initials': 'SE', 'LastName': 'Moussa', 'Affiliation': 'Adobe Clinical Research, Tucson, AZ, United States.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Kohli', 'Affiliation': 'Arizona Liver Health, Chandler, AZ, United States.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Nelson', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, CA, United States.'}, {'ForeName': 'Mildred', 'Initials': 'M', 'LastName': 'Gottwald', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, CA, United States.'}, {'ForeName': 'William C G', 'Initials': 'WCG', 'LastName': 'Chang', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, CA, United States.'}, {'ForeName': 'Andrew Z', 'Initials': 'AZ', 'LastName': 'Yan', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, CA, United States.'}, {'ForeName': 'Alex M', 'Initials': 'AM', 'LastName': 'DePaoli', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, CA, United States.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Ling', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, CA, United States. Electronic address: lling@ngmbio.com.'}, {'ForeName': 'Hsiao D', 'Initials': 'HD', 'LastName': 'Lieu', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, CA, United States.'}]",Gastroenterology,['10.1053/j.gastro.2020.08.004']
2186,31879857,Associations of Changes in Organizational Justice with Job Attitudes and Health-Findings from a Prospective Study Using a Matching-Based Difference-in-Difference Approach.,"BACKGROUND


Ample evidence indicates that unfairness at the workplace (organizational injustice) is associated with both job attitudes and health of employees. Several factors that influence these associations have been identified: e.g., personality traits, such as the Big Five traits, justice sensitivity, type of occupation (e.g., white-collar), and unobserved time-invariant factors. Previous studies only addressed parts of these issues, and the ideal research design to mitigate biases-an experiment with random assignment to a treatment and control group-is not feasible. This study therefore mimics a randomized experiment using two statistical techniques.
METHODS


First, matching was implemented to balance the treatment and control group in confounding factors (demographics and personality) in two prospective waves (2012-2014) of observational data (4522 white-collar, 2984 blue-collar) taken from the Linked Personnel Panel, which is an employee survey representative for German private sector companies with more than 50 employees. Second, a difference-in-difference approach excludes unobserved time-invariant factors by estimating associations of changes in organizational justice (distributive, procedural, interactional) with job attitudes (job satisfaction, turnover intention) and health (general and mental) in these groups, separate for white- and blue-collar employees.
RESULTS


A decrease in perceived justice was associated with lower job attitudes (less job satisfaction and higher turnover intentions), while an increase was associated with higher values. This pattern was found for white- and blue-collar workers and also for health indicators, with the latter, however, being less pronounced.
CONCLUSIONS


Increased fairness at the workplace is related to better job attitudes and health for white- and blue-collar employees, independent of personality traits and unobserved time-invariant factors.",2020,"CONCLUSIONS


Increased fairness at the workplace is related to better job attitudes and health for white- and blue-collar employees, independent of personality traits and unobserved time-invariant factors.","['two prospective waves (2012-2014) of observational data (4522 white-collar, 2984 blue-collar) taken from the Linked Personnel Panel, which is an employee survey representative for German private sector companies with more than 50 employees']",[],"['perceived justice', 'job satisfaction and higher turnover intentions', 'organizational justice (distributive, procedural, interactional) with job attitudes (job satisfaction, turnover intention) and health (general and mental', 'lower job attitudes']","[{'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0175751', 'cui_str': 'Cervical collar'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0033176', 'cui_str': 'Private Sector'}, {'cui': 'C0439093', 'cui_str': '>'}]",[],"[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0022437', 'cui_str': 'Justice'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0031227', 'cui_str': 'Employee Turnover'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0029246', 'cui_str': 'Organizations'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",,0.0185265,"CONCLUSIONS


Increased fairness at the workplace is related to better job attitudes and health for white- and blue-collar employees, independent of personality traits and unobserved time-invariant factors.","[{'ForeName': 'Raphael M', 'Initials': 'RM', 'LastName': 'Herr', 'Affiliation': 'Mannheim Institute of Public Health, Social and Preventive Medicine, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany. raphael.herr@medma.uni-heidelberg.de.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Almer', 'Affiliation': 'Mannheim Institute of Public Health, Social and Preventive Medicine, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Catherin', 'Initials': 'C', 'LastName': 'Bosle', 'Affiliation': 'Mannheim Institute of Public Health, Social and Preventive Medicine, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Joachim E', 'Initials': 'JE', 'LastName': 'Fischer', 'Affiliation': 'Mannheim Institute of Public Health, Social and Preventive Medicine, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}]",International journal of behavioral medicine,['10.1007/s12529-019-09841-z']
2187,32773515,Efficacy of Triamcinolone-Soaked Nasal Packing on Endoscopic Dacryocystorhinostomy.,"PURPOSE


To evaluate the efficacy of triamcinolone-soaked nasal packing in endoscopic dacryocystorhinostomy (EDCR).
METHODS


Patients who underwent EDCR between September 2012 and August 2017 were included. They were assigned to triamcinolone (201 eyes) or control (206 eyes) group based on the order of surgery. Granulation occurrence and outcome were assessed at 3 and 6 months postoperatively, respectively.
RESULTS


The success rates were 94.3% (overall anatomical success), 90.4% (complete anatomical success), 92.1% (overall functional success), and 76.7% (complete functional success). The overall functional success rate was significantly higher in the triamcinolone group (95.0% vs. 89.3%, p = 0.033). The overall anatomical success rate (96.0% vs. 92.7%, p = 0.149) and complete functional success rate (79.6% vs. 73.8%, p = 0.166) were also higher in the triamcinolone group, but this difference was not statistically significant. Granulation occurred in 62 eyes (15.2%); the incidence was significantly lower in the triamcinolone group (10.0% vs. 20.4%, p = 0.003).
CONCLUSION


The authors suggest that use of triamcinolone-soaked nasal packing in EDCR is effective in significantly reducing the incidence of postoperative granulation and epiphora.",2020,"The overall anatomical success rate (96.0% vs. 92.7%, p = 0.149) and complete functional success rate (79.6% vs. 73.8%, p = 0.166) were also higher in the triamcinolone group, but this difference was not statistically significant.",['Patients who underwent EDCR between September 2012 and August 2017 were included'],"['triamcinolone-soaked nasal packing', 'triamcinolone', 'Triamcinolone-Soaked Nasal Packing']","['overall functional success rate', 'Granulation', 'overall anatomical success rate', 'complete functional success rate', 'success rates', 'Endoscopic Dacryocystorhinostomy', 'Granulation occurrence and outcome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0395256', 'cui_str': 'Intranasal dacryocystorhinostomy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0204774', 'cui_str': 'Soak'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0395256', 'cui_str': 'Intranasal dacryocystorhinostomy'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0588063,"The overall anatomical success rate (96.0% vs. 92.7%, p = 0.149) and complete functional success rate (79.6% vs. 73.8%, p = 0.166) were also higher in the triamcinolone group, but this difference was not statistically significant.","[{'ForeName': 'Tae Seen', 'Initials': 'TS', 'LastName': 'Kang', 'Affiliation': 'Department of Ophthalmology, Chungnam National University School of Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Yeo Kyoung', 'Initials': 'YK', 'LastName': 'Won', 'Affiliation': 'Department of Ophthalmology, Chungnam National University School of Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Jung Yeul', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, Chungnam National University School of Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Kyoung Nam', 'Initials': 'KN', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, Chungnam National University School of Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Sung Bok', 'Initials': 'SB', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology, Chungnam National University School of Medicine, Daejeon, Republic of Korea.'}]",Ophthalmic plastic and reconstructive surgery,['10.1097/IOP.0000000000001791']
2188,32773519,CORR Insights®: Does Virtual Reality Improve Procedural Completion and Accuracy in an Intramedullary Tibial Nail Procedure? A Randomized Control Trial.,,2020,,[],['CORR Insights®'],[],[],"[{'cui': 'C0233820', 'cui_str': 'Insight'}]",[],,0.0649477,,"[{'ForeName': 'Brian B', 'Initials': 'BB', 'LastName': 'Gilmer', 'Affiliation': 'B. B. Gilmer, Mammoth Orthopedic Institute, Mammoth Lakes, CA, USA.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001432']
2189,32773524,Comparison of Clinical Options: High-Fidelity Manikin-Based and Virtual Simulation.,"BACKGROUND


Minimal evidence compares nursing student outcomes when replacing clinical hours with manikin-based high-fidelity patient simulation (HFPS) or virtual simulation.
PURPOSE


The study aims were to compare differences in outcomes: (1) between 2 intervention groups (HFPS or virtual simulation) when replacing 25% of pediatric/obstetrics clinical hours and (2) pass/fail for clinical practice between the intervention groups and a face-to-face clinical group (control).
METHODS


A quasi-experimental study was conducted to determine differences in knowledge between intervention groups participating in 6 pediatric/obstetrics simulation scenarios.
RESULTS


No differences in composite knowledge were found between simulation groups (P = .319). There also was no difference in clinical practice pass/fail among the groups.
CONCLUSIONS


HFPS and virtual simulation were equally effective in achieving learning goals.",2020,No differences in composite knowledge were found between simulation groups (P = .319).,['intervention groups participating in 6 pediatric/obstetrics simulation scenarios'],"['2 intervention groups (HFPS or virtual simulation) when replacing 25% of pediatric/obstetrics clinical hours and (2) pass/fail for clinical practice between the intervention groups and a face-to-face clinical group (control', 'Fidelity Manikin-Based and Virtual Simulation']",['composite knowledge'],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0085137', 'cui_str': 'Patient Simulation'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0226758,No differences in composite knowledge were found between simulation groups (P = .319).,"[{'ForeName': 'Desiree A', 'Initials': 'DA', 'LastName': 'Díaz', 'Affiliation': 'Author Affiliations: Assistant Professor (Dr Díaz), Associate Professor (Drs Anderson and Quelly), Instructor (Ms Hill), and Research Assistant (Ms Lynn), Department of Nursing Practice, University of Central Florida, Orlando; and PhD Candidate (Ms Clark), School of Nursing, Community Health Systems, University of California, San Francisco.'}, {'ForeName': 'Mindi', 'Initials': 'M', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'Peggy P', 'Initials': 'PP', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Quelly', 'Affiliation': ''}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Clark', 'Affiliation': ''}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Lynn', 'Affiliation': ''}]",Nurse educator,['10.1097/NNE.0000000000000906']
2190,32773545,Influence of Resisted Sled-Pull Training on the Sprint Force-Velocity Profile of Male High-School Athletes.,"Cahill, MJ, Oliver, JL, Cronin, JB, Clark, K, Cross, MR, Lloyd, RS, and Lee, JE. Influence of resisted sled-pull training on the sprint force-velocity profile of male high-school athletes. J Strength Cond Res XX(X): 000-000, 2020-Although resisted sled towing is a commonly used method of sprint-specific training, little uniformity exists around training guidelines for practitioners. The aim of this study was to assess the effectiveness of unresisted and resisted sled-pull training across multiple loads. Fifty-three male high-school athletes were assigned to an unresisted (n = 12) or 1 of 3 resisted groups: light (n = 15), moderate (n = 14), and heavy (n = 12) corresponding to loads of 44 ± 4 %BM, 89 ± 8 %BM, and 133 ± 12 %BM that caused a 25, 50, and 75% velocity decrement in maximum sprint speed, respectively. All subjects performed 2 sled-pull training sessions twice weekly for 8 weeks. Split times of 5, 10, and 20 m improved across all resisted groups (d = 0.40-1.04, p < 0.01) but did not improve with unresisted sprinting. However, the magnitude of the gains increased most within the heavy group, with the greatest improvement observed over the first 10 m (d ≥ 1.04). Changes in preintervention to postintervention force-velocity profiles were specific to the loading prescribed during training. Specifically, F0 increased most in moderate to heavy groups (d = 1.08-1.19); Vmax significantly decreased in the heavy group but increased in the unresisted group (d = 012-0.44); whereas, Pmax increased across all resisted groups (d = 0.39-1.03). The results of this study suggest that the greatest gains in short distance sprint performance, especially initial acceleration, are achieved using much heavier sled loads than previously studied in young athletes.",2020,"Specifically, F0 increased most in moderate to heavy groups (d = 1.08-1.19); Vmax significantly decreased in the heavy group but increased in the unresisted group (d = 012-0.44); whereas, Pmax increased across all resisted groups (d = 0.39-1.03).","['young athletes', 'Fifty-three male high-school athletes', 'Male High-School Athletes', 'male high-school athletes']","['J Strength Cond Res XX(X', 'unresisted and resisted sled-pull training', 'resisted sled-pull training', 'Resisted Sled-Pull Training']","['Cahill, MJ, Oliver, JL, Cronin, JB, Clark, K, Cross, MR, Lloyd, RS, and Lee, JE', 'short distance sprint performance', 'Pmax']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",53.0,0.0160647,"Specifically, F0 increased most in moderate to heavy groups (d = 1.08-1.19); Vmax significantly decreased in the heavy group but increased in the unresisted group (d = 012-0.44); whereas, Pmax increased across all resisted groups (d = 0.39-1.03).","[{'ForeName': 'Micheál J', 'Initials': 'MJ', 'LastName': 'Cahill', 'Affiliation': 'Applied Health and Performance Department, Athlete Training and Health, Allen, Texas.'}, {'ForeName': 'Jon L', 'Initials': 'JL', 'LastName': 'Oliver', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Cronin', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Clark', 'Affiliation': 'Department of Kinesiology, West Chester University, West Chester, Pennsylvania.'}, {'ForeName': 'Matt R', 'Initials': 'MR', 'LastName': 'Cross', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Rhodri S', 'Initials': 'RS', 'LastName': 'Lloyd', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Jeong E', 'Initials': 'JE', 'LastName': 'Lee', 'Affiliation': 'Department of Statistics, University of Auckland, Auckland, New Zealand.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003770']
2191,32773581,"The effect of aspirin on preeclampsia, intrauterine growth restriction and preterm delivery among healthy pregnancies with a history of preeclampsia.","BACKGROUND


Due to the significance of Preeclampsia (PE) and its adverse outcomes in the health of both mother and newborn, the present study was carried out to investigate the effect of aspirin on preventing the occurrence of PE, Intrauterine Growth Restriction (IUGR), and preterm delivery in women with a previous history of PE.
METHODS


The present clinical trial was conducted on 90 pregnant women with a previous history of PE referred to the Khalij Fars Hospital in Bandar Abbas, Hormozgan Province Iran from April 2017 to August 2018. The subjects of the study were randomly assigned into two groups of intervention and control to receive either 80 mg of aspirin or placebo daily during the pregnancy. Patients' information was obtained and recorded upon entering the study, follow-up visits, and childbirth.
RESULTS


Among participants who entered the clinical trial, 86 patients (95.6%) completed the study. During the pregnancy, systolic blood pressure increased by 8.25 ± 14.83 and 19.06 ± 18.33 mmHg in aspirin and placebo groups, respectively (p=0.001). Also, the same happened with diastolic blood pressure (6.12 ± 11.46 vs. 13.48 ± 13.95 mmHg, p=0.010). The rate of PE was equal to 27 (62.8%) and 38 (88.4%) in the aspirin and placebo groups, respectively (aOR= 0.23, p= 0.013). In the aspirin group, the rate of IUGR was equal to 27.9% compared to 25.6% of newborns in the control group (aOR= 1.18, p=0.750). Similarly, there was no significant difference in the rate of preterm delivery between the two groups (p=0.061).
CONCLUSION


The findings of the present study conducted exclusively on the women with previous documented PE revealed that taking aspirin may have a preventive effect on PE in the current pregnancy.",2020,"Similarly, there was no significant difference in the rate of preterm delivery between the two groups (p=0.061).
","['participants who entered the clinical trial, 86 patients (95.6%) completed the study', '90 pregnant women with a previous history of PE referred to the Khalij Fars Hospital in Bandar Abbas, Hormozgan Province Iran from April 2017 to August 2018', 'healthy pregnancies with a history of preeclampsia']","['intervention and control to receive either 80 mg of aspirin or placebo', 'aspirin', 'placebo']","['rate of IUGR', 'preeclampsia, intrauterine growth restriction and preterm delivery', 'rate of PE', 'systolic blood pressure', 'diastolic blood pressure', 'occurrence of PE, Intrauterine Growth Restriction (IUGR), and preterm delivery', 'rate of preterm delivery']","[{'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C4076023', 'cui_str': 'History of pre-eclampsia'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",90.0,0.0760191,"Similarly, there was no significant difference in the rate of preterm delivery between the two groups (p=0.061).
","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Abdi', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Afsane', 'Initials': 'A', 'LastName': 'Rozrokh', 'Affiliation': 'Student Research Committee, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Azin', 'Initials': 'A', 'LastName': 'Alavi', 'Affiliation': 'Fertility and Infertility Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Zare', 'Affiliation': 'Epidemiology Department, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Homeira', 'Initials': 'H', 'LastName': 'Vafaei', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Asadi', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kasraeian', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Hessami', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Journal of the Chinese Medical Association : JCMA,['10.1097/JCMA.0000000000000400']
2192,32773594,Tapentadol versus oxycodone for postoperative pain treatment the first 7 days after total knee arthroplasty: a randomized clinical trial.,"Pain after total knee arthroplasty (TKA) is a prevalent condition. This study compared the effectiveness of tapentadol extended release (ER) 50 mg x 2, oxycodone controlled release (CR) 10 mg x 2 and placebo; as added to a multimodal analgesic regime both in-hospital and at home the first week after TKA. The study was randomized and blinded for investigators, staff, outcome assessors and patients. Follow-up included pain intensity on mobilization, pain at rest, worst pain in the previous 24 hours, and adverse effects measured on 0-10 numeric rate scales. A total of 134 patients in three study groups received their allocated intervention and were included in the analysis. The primary outcome pain on mobilization the 7 first postoperative days reported as mean pain Area Under the Curve (AUC) was 528.1 (SD 267.5, IQR 356.6 to 665.4) for placebo, 427.2 (SD 203.9, IQR 303.6 to 544.3) for tapentadol ER and 507.9 (SD 243.7, IQR 292.4 to 686.8) for oxycodone CR (p=0.12). With the exception of constipation being less prevalent in the tapentadol ER group (p=0.02), we found no significant differences between treatment groups for the secondary outcomes. Tapentadol ER as an add-on to multimodal analgesia did not significantly improve pain relief when compared to oxycodone CR or placebo. Constipation was lowest in the tapentadol ER group.",2020,Tapentadol ER as an add-on to multimodal analgesia did not significantly improve pain relief when compared to oxycodone CR or placebo.,"['postoperative pain treatment the first 7 days after total knee arthroplasty', 'Pain after total knee arthroplasty (TKA', '134 patients in three study groups received their allocated intervention and were included in the analysis']","['Tapentadol versus oxycodone', 'tapentadol extended release (ER) 50 mg x 2, oxycodone controlled release (CR) 10 mg', 'Tapentadol ER', 'oxycodone CR or placebo', 'tapentadol ER', 'placebo']","['pain on mobilization the 7 first postoperative days reported as mean pain Area Under the Curve (AUC', 'pain intensity on mobilization, pain at rest, worst pain in the previous 24 hours, and adverse effects', 'pain relief', 'Constipation']","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C2001271', 'cui_str': 'tapentadol'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]",134.0,0.482635,Tapentadol ER as an add-on to multimodal analgesia did not significantly improve pain relief when compared to oxycodone CR or placebo.,"[{'ForeName': 'Torbjørn', 'Initials': 'T', 'LastName': 'Rian', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, St. Olavs hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Eirik', 'Initials': 'E', 'LastName': 'Skogvoll', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, St. Olavs hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Hofstad', 'Affiliation': 'Department of Orthopaedic Surgery, St. Olavs hospital, Trondheim University hospital, Trondheim, Norway.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Høvik', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, St. Olavs hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Siri B', 'Initials': 'SB', 'LastName': 'Winther', 'Affiliation': 'Department of Orthopaedic Surgery, St. Olavs hospital, Trondheim University hospital, Trondheim, Norway.'}, {'ForeName': 'Vigdis Schnell', 'Initials': 'VS', 'LastName': 'Husby', 'Affiliation': 'Department of Orthopaedic Surgery, St. Olavs hospital, Trondheim University hospital, Trondheim, Norway.'}, {'ForeName': 'Jomar', 'Initials': 'J', 'LastName': 'Klaksvik', 'Affiliation': 'Department of Orthopaedic Surgery, St. Olavs hospital, Trondheim University hospital, Trondheim, Norway.'}, {'ForeName': 'Tarjei', 'Initials': 'T', 'LastName': 'Egeberg', 'Affiliation': 'Department of Orthopaedic Surgery, St. Olavs hospital, Trondheim University hospital, Trondheim, Norway.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Sand', 'Affiliation': 'Department of Health Research, SINTEF Digital, Trondheim, Norway.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Klepstad', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, St. Olavs hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Tina Strømdal', 'Initials': 'TS', 'LastName': 'Wik', 'Affiliation': 'Department of Orthopaedic Surgery, St. Olavs hospital, Trondheim University hospital, Trondheim, Norway.'}]",Pain,['10.1097/j.pain.0000000000002026']
2193,32773596,"Effect of combined pharmacological, behavioral, and physical interventions for procedural pain on salivary cortisol and neurobehavioral development in preterm infants: a randomized controlled trial.","Repeated procedural pain may lead to increased secretion of cortisol and future neurobehavioral development disorders in preterm infants. Changes in cortisol level may mediate the effect of neonatal repetitive procedural pain on altered childhood neurobehavioral development in preterm infants. However, few studies have investigated the effect of combined pharmacological, behavioral, and physical interventions over repeated painful procedures on pain response, cortisol level and neurobehavioral development. The present study examined (1) the efficacy and safety of sucrose combined with massage, music, non-nutritive sucking and gentle human touch to treat preterm infants with repeated procedural pain; (2) cortisol level at discharge from the neonatal intensive care unit (NICU); (3) neurobehavioral development at 40 weeks' corrected gestational age; (4) the potential mediating effect of cortisol level in the combined interventions on neurobehavioral development. Stable preterm infants (n=76) were randomized to receive routine care or combined interventions across repeated painful procedures throughout their NICU stay. The preterm infant pain profile (PIPP) scores in the early, middle, and late periods of the NICU stay were measured, as were basal salivary cortisol level at admission and discharge, neonatal behavioral neurological assessment score at 40 weeks' corrected gestational age, and the incidence of adverse effects during the study period. Our findings indicated that the combined interventions remained efficacious and safe for reducing repeated procedural pain, decreased the cortisol level at discharge, and promoted early neurobehavioral development in preterm infants. This effect may have been mediated via decreased cortisol levels and reduced repeated procedural pain.",2020,"Our findings indicated that the combined interventions remained efficacious and safe for reducing repeated procedural pain, decreased the cortisol level at discharge, and promoted early neurobehavioral development in preterm infants.","['Stable preterm infants (n=76', ""preterm infants with repeated procedural pain; (2) cortisol level at discharge from the neonatal intensive care unit (NICU); (3) neurobehavioral development at 40 weeks' corrected gestational age; (4"", 'preterm infants']","['sucrose combined with massage, music, non-nutritive sucking and gentle human touch', 'routine care or combined interventions across repeated painful procedures throughout their NICU stay', 'combined pharmacological, behavioral, and physical interventions']","['salivary cortisol and neurobehavioral development', 'basal salivary cortisol level at admission and discharge, neonatal behavioral neurological assessment score', 'pain response, cortisol level and neurobehavioral development', 'cortisol level', 'preterm infant pain profile (PIPP) scores in the early, middle, and late periods of the NICU stay', 'efficacy and safety', 'cortisol levels']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1619712', 'cui_str': 'Procedural pain'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}]","[{'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C1271035', 'cui_str': 'Provision of non-nutritive sucking'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0240322', 'cui_str': 'Menstrual period late'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",76.0,0.0863337,"Our findings indicated that the combined interventions remained efficacious and safe for reducing repeated procedural pain, decreased the cortisol level at discharge, and promoted early neurobehavioral development in preterm infants.","[{'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'School of Nursing, Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Guihua', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'School of Nursing, Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""Children's Hospital of Nanjing Medical University, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Lv', 'Affiliation': ""Children's Hospital of Nanjing Medical University, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Rong', 'Affiliation': ""Children's Hospital of Nanjing Medical University, China.""}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Mi', 'Affiliation': 'School of Nursing, Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""Children's Hospital of Nanjing Medical University, China.""}]",Pain,['10.1097/j.pain.0000000000002015']
2194,32773637,Enhanced Stress Resilience Training in Surgeons: Iterative Adaptation and Biopsychosocial Effects in 2 Small Randomized Trials.,"OBJECTIVE


To determine the effects of ESRT (an iteratively adapted and tailored MBI) on perceived stress, executive cognitive function, psychosocial well-being (ie, burnout, mindfulness), and pro-inflammatory gene expression in surgical (ESRT-1) and mixed specialty (ESRT-2) PGY-1 volunteers.
SUMMARY OF BACKGROUND AND DATA


Tailored MBIs have proven beneficial in multiple high-stress and high-performance populations. In surgeons, tailored MBIs have been shown to be feasible and potentially beneficial, but whether mindfulness-based cognitive training can improve perceived stress, executive function, well-being or physiological distress in surgical and nonsurgical trainees is unknown.
METHODS


In 2 small single-institution randomized clinical trials, ESRT, a tailored mindfulness-based cognitive training program, was administered and iteratively adapted for first-year surgical (ESRT-1, 8 weekly, 2-hour classes, n = 44) and mixed specialty (ESRT-2, 6 weekly, 90-minute classes, n = 45) resident trainees. Primary and secondary outcomes were, respectively, perceived stress and executive function. Other prespecified outcomes were burnout (assessed via Maslach Burnout Inventory), mindfulness (assessed via Cognitive Affective Mindfulness Scale - Revised), and pro-inflammatory gene expression (assessed through the leukocyte transcriptome profile ""conserved transcriptional response to adversity"").
RESULTS


Neither version of ESRT appeared to affect perceived stress. Higher executive function and mindfulness scores were seen in ESRT-1, and lower emotional exhaustion and depersonalization scores in ESRT-2, at pre-/postintervention and/or 50-week follow-up (ESRT-1) or at 32-week follow-up (ESRT-2), compared to controls. Pooled analysis of both trials found ESRT-treated participants had reduced pro-inflammatory RNA expression compared to controls.
CONCLUSIONS


This pilot work suggests ESRT can variably benefit executive function, burnout, and physiologic distress in PGY-1 trainees, with potential for tailoring to optimize effects.",2020,"Higher executive function and mindfulness scores were seen in ESRT-1, and lower emotional exhaustion and depersonalization scores in ESRT-2, at pre-/postintervention and/or 50-week follow-up (ESRT-1) or at 32-week follow-up (ESRT-2), compared to controls.","['Surgeons', 'surgical (ESRT-1) and mixed specialty (ESRT-2) PGY-1 volunteers']",['ESRT'],"['Higher executive function and mindfulness scores', 'burnout (assessed via Maslach Burnout Inventory), mindfulness (assessed via Cognitive Affective Mindfulness Scale - Revised), and pro-inflammatory gene expression (assessed through the leukocyte transcriptome profile ""conserved transcriptional response to adversity', 'perceived stress and executive function', 'reduced pro-inflammatory RNA expression', 'emotional exhaustion and depersonalization scores', 'perceived stress, executive cognitive function, psychosocial well-being (ie, burnout, mindfulness), and pro-inflammatory gene expression']","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C1956267', 'cui_str': 'Transcriptome Profiles'}, {'cui': 'C0040649', 'cui_str': 'Genetic transcription'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0011551', 'cui_str': 'Depersonalization'}, {'cui': 'C0589089', 'cui_str': 'Executive cognitive functions'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",45.0,0.0370296,"Higher executive function and mindfulness scores were seen in ESRT-1, and lower emotional exhaustion and depersonalization scores in ESRT-2, at pre-/postintervention and/or 50-week follow-up (ESRT-1) or at 32-week follow-up (ESRT-2), compared to controls.","[{'ForeName': 'Carter C', 'Initials': 'CC', 'LastName': 'Lebares', 'Affiliation': 'Department of Surgery, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Troy N', 'Initials': 'TN', 'LastName': 'Coaston', 'Affiliation': 'Department of Surgery, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Delucchi', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Ekaterina V', 'Initials': 'EV', 'LastName': 'Guvva', 'Affiliation': 'Department of Surgery, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Wen T', 'Initials': 'WT', 'LastName': 'Shen', 'Affiliation': 'Department of Surgery, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Staffaroni', 'Affiliation': 'Department of Neurology, Weill Institute for Neurosciences, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Joel H', 'Initials': 'JH', 'LastName': 'Kramer', 'Affiliation': 'Department of Neurology, Weill Institute for Neurosciences, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Elissa S', 'Initials': 'ES', 'LastName': 'Epel', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Frederick M', 'Initials': 'FM', 'LastName': 'Hecht', 'Affiliation': 'Department of Internal Medicine, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Ascher', 'Affiliation': 'Department of Surgery, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Hobart W', 'Initials': 'HW', 'LastName': 'Harris', 'Affiliation': 'Department of Surgery, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Cole', 'Affiliation': 'Department of Psychiatry & Biobehavioral Sciences, and Department of Medicine, University of California, Los Angeles.'}]",Annals of surgery,['10.1097/SLA.0000000000004145']
2195,32773651,Effect of vitamin D supplementation during pregnancy on mid-to-late gestational blood pressure in a randomized controlled trial in Bangladesh.,"OBJECTIVE


To examine the dose-dependent effect of maternal vitamin D during pregnancy on blood pressure from mid-to-late gestation within the context of a randomized, placebo-controlled trial of vitamin D supplementation in Bangladesh (n = 1298).
METHODS


Healthy women without hypertension were enrolled at 17-24 weeks gestation and randomized to one of four vitamin D doses during pregnancy: placebo, 4200, 16 800 or 28 000 IU/week. This substudy examined 1257 women with blood pressure measured at enrollment with at least one other timepoint (measurements included at 24, 30 weeks, and weekly from 36 weeks until delivery). Effects of vitamin D on SBP or DBP were analyzed using mixed-effects models.
RESULTS


Vitamin D did not have an effect on SBP or DBP at 24 or 30 weeks; blood pressure was higher at 36 weeks for the highest dose versus placebo [mean difference (95% CI) mmHg: SBP = 2.3 (0.9-3.7); DBP = 1.9 (0.7-3.0)]. The differences in changes in SBP and DBP between vitamin D groups and placebo across intervals were small (P > 0.10), but the difference for 28 000 IU/week versus placebo was the highest from 30 to 36 weeks [SBP 0.2 (-0.1 to 0.5) and DBP 0.2 (-0.0 to 0.4) mmHg].
CONCLUSION


Vitamin D supplementation starting mid-pregnancy did not affect SBP or DBP until late gestation, and then only at the highest dose. These results do not support the clinical use of vitamin D in pregnancy to lower maternal blood pressure.",2020,"RESULTS


Vitamin D did not have an effect on SBP or DBP at 24 or 30 weeks; blood pressure was higher at 36 weeks for the highest dose versus placebo [mean difference (95% CI)","['Bangladesh (n\u200a=\u200a1298', 'mmHg', 'Healthy women without hypertension were enrolled at 17-24 weeks gestation', '1257 women with blood pressure measured at enrollment with at least one other timepoint (measurements included at 24, 30 weeks, and weekly from 36 weeks until delivery', 'pregnancy on mid-to-late gestational blood pressure in a randomized controlled trial in Bangladesh']","['maternal vitamin D', 'Vitamin D supplementation', 'vitamin D doses during pregnancy: placebo', 'vitamin D', 'vitamin D supplementation', 'placebo']","['blood pressure', 'SBP and DBP', 'maternal blood pressure', 'SBP or DBP']","[{'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0104487', 'cui_str': 'AT 17'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",1257.0,0.522405,"RESULTS


Vitamin D did not have an effect on SBP or DBP at 24 or 30 weeks; blood pressure was higher at 36 weeks for the highest dose versus placebo [mean difference (95% CI)","[{'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Subramanian', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, Pennsylvania, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Korsiak', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children.'}, {'ForeName': 'Kellie E', 'Initials': 'KE', 'LastName': 'Murphy', 'Affiliation': 'Department of Obstetrics and Gynecology, Mt. Sinai Hospital, Toronto, Canada.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Al Mahmud', 'Affiliation': 'Nutrition and Clinical Services Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Roth', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children.'}, {'ForeName': 'Alison D', 'Initials': 'AD', 'LastName': 'Gernand', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, Pennsylvania, USA.'}]",Journal of hypertension,['10.1097/HJH.0000000000002609']
2196,32773670,PLASMA RESUSCITATION WITH ADJUNCTIVE PERITONEAL RESUSCITATION REDUCES ISCHEMIC INTESTINAL INJURY FOLLOWING HEMORRHAGIC SHOCK.,"INTRODUCTION


Impaired intestinal microvascular perfusion following resuscitated hemorrhagic shock (HS/RES) leads to ischemia-reperfusion injury, microvascular dysfunction and intestinal epithelial injury, which contribute to the development of multiple organ dysfunction syndrome in some trauma patients. Restoration of central hemodynamics with traditional methods alone often fails to fully restore microvascular perfusion and does not protect against ischemia-reperfusion injury. We hypothesized that resuscitation with fresh frozen plasma (FFP) alone or combined with direct peritoneal resuscitation (DPR) with 2.5%Delflex solution might improve blood flow and decrease intestinal injury compared to conventional resuscitation or resuscitation with DPR alone.
METHODS


Sprague Dawley rats underwent HS (40% mean arterial pressure) for 60 minutes and were randomly assigned to a resuscitation group (n=8): Sham; HS+crystalloid resuscitation(CR) (shed blood+two volumes CR); HS+CR+DPR (intraperitoneal 2.5% peritoneal dialysis fluid (IP)); HS+FFP (shed blood+two volumes FFP); HS+DPR+FFP (IP dialysis fluid+two volumes FFP). Laser Doppler Flowmeter evaluation of the ileum, serum samples for FABP ELISAs, and H&E staining were used to assess intestinal injury and blood flow. P-values <0.05 were considered significant.
RESULTS


Following HS, the addition of DPR to either resuscitation modality improved intestinal blood flow. Four hours after HS/RES, FABP2(intestinal) and FABP6(ileal) were elevated in the CR group but reduced in the FFP and DPR groups. H&E staining demonstrated disrupted intestinal villi in the FFP and CR groups, most significant in the CR group. Combination therapy with FFP and DPR demonstrated negligible cellular injury in H&E graded samples and a significant reduction in FABP levels.
CONCLUSION


HS leads to ischemic-reperfusion injury of the intestine, both FFP and DPR alone attenuated intestinal damage; combination FFP+DPR therapy alleviated most signs of organ injury. Resuscitation with FFP+DPR to restore intestinal blood flow following shock could be an essential method of reducing morbidity and mortality after trauma.Basic Science/NA.",2020,"H&E staining demonstrated disrupted intestinal villi in the FFP and CR groups, most significant in the CR group.",['Sprague Dawley rats underwent HS (40% mean arterial pressure) for 60 minutes and were randomly assigned to a resuscitation group (n=8'],"['resuscitation with fresh frozen plasma (FFP) alone or combined with direct peritoneal resuscitation (DPR) with 2.5%Delflex solution', 'resuscitated hemorrhagic shock (HS/RES', 'Sham; HS+crystalloid resuscitation(CR) (shed blood+two volumes CR); HS+CR+DPR (intraperitoneal 2.5% peritoneal dialysis fluid (IP)); HS+FFP (shed blood+two volumes FFP); HS+DPR+FFP (IP dialysis fluid+two volumes FFP', 'FFP+DPR']","['intestinal villi', 'intestinal blood flow', 'intestinal injury and blood flow', 'blood flow and decrease intestinal injury', 'FABP levels']","[{'cui': 'C0034715', 'cui_str': 'Sprague-Dawley rat'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C2587207', 'cui_str': 'For resuscitation'}, {'cui': 'C0036982', 'cui_str': 'Hemorrhagic shock'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0353714', 'cui_str': 'Peritoneal dialysis solution'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}]","[{'cui': 'C0227266', 'cui_str': 'Intestinal villus'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.079668,"H&E staining demonstrated disrupted intestinal villi in the FFP and CR groups, most significant in the CR group.","[{'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Schucht', 'Affiliation': 'Departments of Surgery.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Matheson', 'Affiliation': 'Departments of Surgery.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Harbrecht', 'Affiliation': 'Departments of Surgery.'}, {'ForeName': 'Logan', 'Initials': 'L', 'LastName': 'Bond', 'Affiliation': 'Departments of Surgery.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Jones', 'Affiliation': 'Department of Surgery, University of Louisville School of Medicine.'}, {'ForeName': 'Khaled J M', 'Initials': 'KJM', 'LastName': 'Alkhateeb', 'Affiliation': 'Pathology University of Louisville.'}, {'ForeName': 'Graham R', 'Initials': 'GR', 'LastName': 'Ashkettle', 'Affiliation': 'Eastern Kentucky University.'}, {'ForeName': 'Jason W', 'Initials': 'JW', 'LastName': 'Smith', 'Affiliation': 'Departments of Surgery.'}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002847']
2197,32781104,A randomized phase II study of pembrolizumab with or without radiation in patients with recurrent or metastatic adenoid cystic carcinoma.,"PURPOSE


We evaluated the safety and efficacy of pembrolizumab (pembro) +/- radiation therapy (RT) in a phase II study among patients with progressive, metastatic adenoid cystic carcinoma (ACC).
METHODS AND MATERIALS


Eligible patients had metastatic ACC with progression within the last year and >=1 measurable lesion. Patients were randomized to pembro alone or with RT to 30 Gray in 5 fractions (pembroRT). The primary endpoint was objective response rate (ORR) outside the RT field. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and local RT responses.
RESULTS


We randomized 20 patients (10 per arm) from 2017- 2018. We did not observe objective response outside of the radiation treatment field; stable disease (SD) was the best response in 12 (60%) patients, not different per arm (7 pembro, 5 pembroRT, P=0.65). A tumor growth rate (TGR) decrease of > 25% was noted among 7 of 12 patients and > 75% in 4 patients. There were local responses in the irradiated field among all evaluable pembroRT subjects. Median PFS and OS were 4.5 / not reached for pembroRT and 6.6 / 27.2 months for pembro patients. One patient developed grade 3 liver enzyme elevation after 27 cycles of therapy. Correlative analyses confirm low levels of Programmed Death-Ligand 1 (PD-L1) expression, and CD8 infiltrating T-cells. We identified associations between local response and both MYB/NFIB translocation and PD-L1 expression, and also between changes in systemic immune populations and RT.
CONCLUSIONS


Pembrolizumab and pembroRT were well-tolerated. We observed no objective responses, but 60% of patients with PD prior to study achieved SD, the majority with decreased TGR, and half (n=10) with clinical benefit (SD>6 months). We observed favorable local responses within the RT field. Additional strategies are needed to further delay progression and effect response.",2020,"Correlative analyses confirm low levels of Programmed Death-Ligand 1 (PD-L1) expression, and CD8 infiltrating T-cells.","['20 patients (10 per arm) from 2017- 2018', 'patients with progressive, metastatic adenoid cystic carcinoma (ACC', 'patients with recurrent or metastatic adenoid cystic carcinoma', 'Eligible patients had metastatic ACC with progression within the last year and >=1 measurable lesion']","['pembrolizumab (pembro) ', 'pembro alone or with RT to 30 Gray in 5 fractions (pembroRT', 'radiation therapy (RT', 'pembrolizumab with or without radiation']","['Programmed Death-Ligand 1 (PD-L1) expression, and CD8 infiltrating T-cells', 'Median PFS and OS', 'objective response rate (ORR) outside the RT field', 'grade 3 liver enzyme elevation', 'progression-free survival (PFS), overall survival (OS), and local RT responses', 'safety and efficacy', 'local responses', 'A tumor growth rate (TGR', 'local response and both MYB/NFIB translocation and PD-L1 expression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0010606', 'cui_str': 'Adenoid cystic carcinoma'}, {'cui': 'C0175754', 'cui_str': 'Agenesis of corpus callosum'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0556636', 'cui_str': 'Gy'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0449249', 'cui_str': 'Growth rate'}, {'cui': 'C0026900', 'cui_str': 'myb Oncogene'}, {'cui': 'C1431185', 'cui_str': 'NFIB protein, human'}, {'cui': 'C0040715', 'cui_str': 'Chromosomal translocation'}]",20.0,0.0272653,"Correlative analyses confirm low levels of Programmed Death-Ligand 1 (PD-L1) expression, and CD8 infiltrating T-cells.","[{'ForeName': 'Umair', 'Initials': 'U', 'LastName': 'Mahmood', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bang', 'Affiliation': 'Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'Yu-Hui', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'Raymond H', 'Initials': 'RH', 'LastName': 'Mak', 'Affiliation': 'Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'Jochen H', 'Initials': 'JH', 'LastName': 'Lorch', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Hanna', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'Mizuki', 'Initials': 'M', 'LastName': 'Nishino', 'Affiliation': 'Department of Imaging, Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Manuszak', 'Affiliation': 'Center for Immuno-Oncology, Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Thrash', 'Affiliation': 'Center for Immuno-Oncology, Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Severgnini', 'Affiliation': 'Center for Immuno-Oncology, Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sanborn', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'Vishwajith', 'Initials': 'V', 'LastName': 'Sridharan', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'Danielle N', 'Initials': 'DN', 'LastName': 'Margalit', 'Affiliation': 'Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'Roy B', 'Initials': 'RB', 'LastName': 'Tishler', 'Affiliation': 'Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Busse', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, USA.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Willers', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, USA.'}, {'ForeName': 'Harvey J', 'Initials': 'HJ', 'LastName': 'Mamon', 'Affiliation': 'Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'Hyung-Jin', 'Initials': 'HJ', 'LastName': 'Yoo', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Sara I', 'Initials': 'SI', 'LastName': 'Pai', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Massachusetts General Hospital, Boston, USA.'}, {'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Wirth', 'Affiliation': 'Department of Medical Oncology, Massachusetts General Hospital, Boston, USA.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Haddad', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'Nicole G', 'Initials': 'NG', 'LastName': 'Chau', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Schoenfeld', 'Affiliation': 'Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, USA. Electronic address: jonathan_schoenfeld@dfci.harvard.edu.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.08.018']
2198,32781112,Maintenance of muscle strength following a one-year resistance training program in older adults.,"BACKGROUND


Muscle mass, strength and function declines with advancing age. Strength training (ST) improves these parameters in older adults, but the gains often disappear after completion of a short-term intervention. The purpose of the present study was to investigate muscle mass, -strength and -function one year after the completion of a successful long-term (12 months) supervised ST program in older adults.
METHOD


Men and women (n = 419, age: 62-70 years) completed one year of supervised heavy resistance training (HRT, n = 143) or moderate intensity resistance training (MIT, n = 144) and were compared to a non-exercising control group (CON, n = 132). At 1-year follow-up, 398 participants returned for measurements of muscle power, -strength and -mass, physical function, body composition, hippocampus volume and physical/mental well-being. The results were compared to pre-training (baseline) and post-training (1-year) values. Further, the participants from the two previous training groups (HRT + MIT, n = 265) were divided into 1) those who on their own continued the ST program (>9 months) the year after completion of the supervised ST program (CONTIN, n = 65) and 2) those who stopped during the follow-up year (<9 months) (STOP, n = 200).
RESULTS


Out of all the improvements obtained after the 1-year training intervention, only knee extensor muscle strength in HRT was preserved at 1-year follow-up (p < 0.0001), where muscle strength was 7% higher than baseline. Additionally, the decrease in muscle strength over the second year was lower in CONTIN than in STOP with decreases of 1% and 6%, respectively (p < 0.05). Only in CONTIN was the muscle strength still higher at 1-year follow-up compared with baseline with a 14% increase (p < 0.0001). The heavy strength training induced increase in whole-body lean mass was erased at 1-year follow-up. However, there was a tendency for maintenance of the cross-sectional area of m. vastus lateralis from baseline to 1-year follow-up in HRT compared with CON (p = 0.06). Waist circumference decreased further over the second year in CONTIN, whereas it increased in STOP (p < 0.05).
CONCLUSION


Even though long-term strength training effectively improved muscle function and other health parameters in older adults, only knee extensor muscle strength was preserved one year after completion of heavy (but not moderate intensity) resistance training. Continuation of strength training resulted in better maintenance of muscle strength and health, which indicates that it is required to continue with physical activity to benefit from the long-term effects of strength training upon muscle function and health in older men and women.",2020,"Waist circumference decreased further over the second year in CONTIN, whereas it increased in STOP (p < 0.05).
","['older adults', 'Men and women (n\u202f=\u202f419, age: 62-70\u202fyears) completed one year of', 'older men and women']","['Strength training (ST', 'training intervention', 'supervised heavy resistance training (HRT, n\u202f=\u202f143) or moderate intensity resistance training (MIT, n\u202f=\u202f144) and were compared to a non-exercising control', 'heavy strength training', 'strength training', 'successful long-term (12\u202fmonths) supervised ST program']","['knee extensor muscle strength', 'knee extensor muscle strength in HRT', 'Waist circumference', 'muscle function and other health parameters', 'muscle strength still higher', 'muscle power, -strength and -mass, physical function, body composition, hippocampus volume and physical/mental well-being', 'muscle strength', 'whole-body lean mass']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}]",265.0,0.0132112,"Waist circumference decreased further over the second year in CONTIN, whereas it increased in STOP (p < 0.05).
","[{'ForeName': 'Anne Theil', 'Initials': 'AT', 'LastName': 'Gylling', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Nielsine Nielsensvej 11, 2400 Copenhagen, NV, Denmark; Center for Healthy Ageing, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark. Electronic address: a_gylling@hotmail.com.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Bloch-Ibenfeldt', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Nielsine Nielsensvej 11, 2400 Copenhagen, NV, Denmark; Center for Healthy Ageing, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Christian Skou', 'Initials': 'CS', 'LastName': 'Eriksen', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Nielsine Nielsensvej 11, 2400 Copenhagen, NV, Denmark; Center for Healthy Ageing, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Andreas Kraag', 'Initials': 'AK', 'LastName': 'Ziegler', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Nielsine Nielsensvej 11, 2400 Copenhagen, NV, Denmark; Center for Healthy Ageing, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Cathrine Lawaetz', 'Initials': 'CL', 'LastName': 'Wimmelmann', 'Affiliation': 'Center for Healthy Ageing, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark; Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Øster Farimagsgade 5A, 1353 Copenhagen K, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Baekgaard', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Nielsine Nielsensvej 11, 2400 Copenhagen, NV, Denmark; Center for Healthy Ageing, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Carl-Johan', 'Initials': 'CJ', 'LastName': 'Boraxbekk', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Nielsine Nielsensvej 11, 2400 Copenhagen, NV, Denmark; Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark; Department of Radiation Sciences, Umeå University, S-901 87 Umeå, Sweden.'}, {'ForeName': 'Hartwig Roman', 'Initials': 'HR', 'LastName': 'Siebner', 'Affiliation': 'Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark; Department of Neurology, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark.'}, {'ForeName': 'Erik Lykke', 'Initials': 'EL', 'LastName': 'Mortensen', 'Affiliation': 'Center for Healthy Ageing, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark; Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Øster Farimagsgade 5A, 1353 Copenhagen K, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kjaer', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Nielsine Nielsensvej 11, 2400 Copenhagen, NV, Denmark; Center for Healthy Ageing, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.'}]",Experimental gerontology,['10.1016/j.exger.2020.111049']
2199,32781178,"A phase 2 double-blinded, placebo-controlled trial of toll-like receptor 7,8,9 antagonist, IMO-8400, in dermatomyositis.",,2020,,[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.553573,,"[{'ForeName': 'Yoo Jung', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Stanford University School of Medicine, Redwood City, CA, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Schiopu', 'Affiliation': 'Department of Rheumatology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Katalin', 'Initials': 'K', 'LastName': 'Dankó', 'Affiliation': 'Department of Clinical Immunology, Medical Faculty, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'Tahseen', 'Initials': 'T', 'LastName': 'Mozaffar', 'Affiliation': 'Department of Neurology, University of California Irvine, Irvine, CA, USA.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Chunduru', 'Affiliation': 'Idera Pharmaceuticals, Inc., Exton, PA, USA.'}, {'ForeName': 'Kirstin', 'Initials': 'K', 'LastName': 'Lees', 'Affiliation': 'Idera Pharmaceuticals, Inc., Exton, PA, USA.'}, {'ForeName': 'Namita', 'Initials': 'N', 'LastName': 'Goyal', 'Affiliation': 'Department of Neurology, University of California Irvine, Irvine, CA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Sarazin', 'Affiliation': 'Department of Rheumatology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Fiorentino', 'Affiliation': 'Department of Dermatology, Stanford University School of Medicine, Redwood City, CA, USA. Electronic address: fiorentino@stanford.edu.'}, {'ForeName': 'Kavita Y', 'Initials': 'KY', 'LastName': 'Sarin', 'Affiliation': 'Department of Dermatology, Stanford University School of Medicine, Redwood City, CA, USA. Electronic address: ksarin@stanford.edu.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.07.122']
2200,32781256,A COMPARATIVE EVALUATION OF ILIAC CREST BONE GRAFT WITH AND WITHOUT INJECTABLE AND ADVANCED PLATELET RICH FIBRIN IN SECONDARY ALVEOLAR BONE GRAFTING FOR CLEFT ALVEOLUS IN UNILATERAL CLEFT LIP AND PALATE PATIENTS: A RANDOMIZED PROSPECTIVE STUDY.,"PURPOSE


Platelet rich fibrin enhances bone healing and results in better graft intake and helps in faster periodontal healing. In this study we have used a combination of two newly developed forms of platelet rich fibrin: injectable and advanced along with iliac bone graft for secondary alveolar bone grafting and compared it with cases in which only iliac bone graft was used.
METHODS


30 patients with alveolar cleft, with age group of ≥ 7 years, having complete unilateral cleft alveolus were included and divided into 2 groups of 15 patients each randomly. In Group A, secondary alveolar bone grafting was done using iliac bone graft along with injectable and advanced palate rich fibrin and in Group B, secondary alveolar bone grafting was done only with iliac bone graft. Success of the treatment was assessed using radiographic and clinical methods which included: The bone resorption of the interalveolar septum height of the teeth adjacent to the cleft, evaluated as per Bergland classification, assessment of periodontal status of the teeth adjacent to cleft alveolus.
RESULTS


After 3 months and 6 months postoperatively: study group had better overall scores as per Bergland criteria. Periodontal status improved in both groups but was more in study group compared to control group. For both evaluations the data was clinically favorable in the study group.
CONCLUSION


On preliminary investigations it shows that combination of injectable and advanced platelet rich fibrin seems to enhance bone formation in alveolar clefts when admixed with autologous cancellous bone harvested from the iliac crest than using iliac bone graft alone. It also reduces the chances of bone resorption and show higher percentage of bone volume. Secondary alveolar grafting improves periodontal health around the cleft alveolus.",2020,Periodontal status improved in both groups but was more in study group compared to control group.,"['30 patients with alveolar cleft, with age group of ≥ 7 years, having complete unilateral cleft alveolus were included and divided into 2 groups of 15 patients each randomly']","['OF ILIAC CREST BONE', 'Secondary alveolar grafting', 'secondary alveolar bone grafting was done using iliac bone graft along with injectable and advanced palate rich fibrin and in Group B, secondary alveolar bone grafting was done only with iliac bone graft']","['Periodontal status', 'chances of bone resorption', 'bone resorption of the interalveolar septum height', 'periodontal health']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0432084', 'cui_str': 'Cleft of primary palate'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205242', 'cui_str': 'Cleaved'}, {'cui': 'C0227130', 'cui_str': 'Structure of alveolus dentalis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0223651', 'cui_str': 'Iliac crest structure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0407708', 'cui_str': 'Alveolar bone graft'}, {'cui': 'C0020889', 'cui_str': 'Bone structure of ilium'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0015982', 'cui_str': 'Fibrin'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0752060', 'cui_str': 'Septum of Brain'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",30.0,0.0356828,Periodontal status improved in both groups but was more in study group compared to control group.,"[{'ForeName': 'Rao J K', 'Initials': 'RJK', 'LastName': 'Dayashankara', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, College of Dentistry, Qassim University, Buraida, Al Qassim region, Saudi Arabia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bhatnagar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, SGT University, Gurugram, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pandey', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, SGT University, Gurugram, India. Electronic address: rajeevpandeyleo@gmail.com.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Arya', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, SGT University, Gurugram, India.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Arora', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, SGT University, Gurugram, India.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kumar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, SGT University, Gurugram, India.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bootwala', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, College of Dentistry, Qassim University, Buraida, Al Qassim region, Saudi Arabia.'}, {'ForeName': 'W N', 'Initials': 'WN', 'LastName': 'Devi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, SGT University, Gurugram, India.'}]","Journal of stomatology, oral and maxillofacial surgery",['10.1016/j.jormas.2020.07.007']
2201,32781263,"Efficacy and safety of sintilimab plus pemetrexed and platinum as first-line treatment for locally advanced or metastatic nonsquamous non-small cell lung cancer: a randomized, double-blind, phase 3 study (ORIENT-11).","INTRODUCTION


Sintilimab, an anti-programmed death 1 antibody, plus pemetrexed and platinum had shown promising efficacy for nonsquamous non-small cell lung cancer in a phase 1b study. We conducted a randomized, double-blind, phase 3 study to compare the efficacy and safety of sintilimab with placebo, both in combination with such chemotherapy. (ClinicalTrials.gov: NCT03607539) METHODS: A total of 397 patients with previously untreated locally advanced or metastatic nonsquamous NSCLC without sensitizing epidermal growth factor receptor or anaplastic lymphoma kinase genomic aberration were randomized (2:1 ratio) to receive either sintilimab 200 mg or placebo plus pemetrexed and platinum Q3W for 4 cycles, followed by sintilimab or placebo plus pemetrexed therapy. Crossover or treatment beyond disease progression was allowed. The primary endpoint was progression-free survival (PFS) by independent radiographic review committee.
RESULTS


As of Nov. 15, 2019, the median follow-up was 8.9 months. The median PFS was significantly longer in the sintilimab-combination group than that in the placebo-combination group (8.9 vs. 5.0 months; HR, 0.482, 95%CI, 0.362 to 0.643; p < 0.00001). The confirmed objective response rate was 51.9 % (95% CI, 45.7% to 58.0%) in sintilimab-combination group and 29.8% (95% CI, 22.1% to 38.4%) in placebo-combination group. The incidence of grade 3 or higher adverse events was 61.7% in sintilimab-combination group and 58.8% in placebo-combination group.
CONCLUSIONS


In Chinese patients with previously untreated locally advanced or metastatic nonsquamous NSCLC, the addition of sintilimab to chemotherapy of pemetrexed and platinum resulted in significantly longer PFS than that of chemotherapy alone with manageable safety profiles.",2020,"The incidence of grade 3 or higher adverse events was 61.7% in sintilimab-combination group and 58.8% in placebo-combination group.
","['397 patients with previously untreated locally advanced or metastatic nonsquamous NSCLC without sensitizing epidermal growth factor receptor or anaplastic lymphoma kinase genomic aberration', 'locally advanced or metastatic nonsquamous non-small cell lung cancer', 'Chinese patients with previously untreated locally advanced or metastatic nonsquamous NSCLC']","['sintilimab 200 mg or placebo plus pemetrexed and platinum Q3W for 4 cycles, followed by sintilimab or placebo plus pemetrexed therapy', 'sintilimab plus pemetrexed and platinum', 'sintilimab with placebo, both in combination with such chemotherapy']","['Efficacy and safety', 'incidence of grade 3 or higher adverse events', 'efficacy and safety', 'progression-free survival (PFS', 'objective response rate', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0252409', 'cui_str': 'ALK Tyrosine Kinase Receptor'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C4760864', 'cui_str': 'sintilimab'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",397.0,0.692513,"The incidence of grade 3 or higher adverse events was 61.7% in sintilimab-combination group and 58.8% in placebo-combination group.
","[{'ForeName': 'Yunpeng', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Medical Oncology Department, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine.'}, {'ForeName': 'Zhehai', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Medical Oncology Department, Shandong Cancer Hospital.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Thoracic Oncology II, Peking University Cancer Hospital.'}, {'ForeName': 'Qitao', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Department of Respiratory Oncology, Affiliated Tumor Hospital of Guangxi Medical University.'}, {'ForeName': 'Baohui', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': 'Department of Respiration, Shanghai Chest Hospital.'}, {'ForeName': 'Shundong', 'Initials': 'S', 'LastName': 'Cang', 'Affiliation': 'Department of Oncology, The Henan Province Hospital of Zhengzhou University.'}, {'ForeName': 'Gongyan', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Respiration, Harbin Medical University Cancer Hospital.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Mei', 'Affiliation': 'Department of Respiration, Anhui Provincial Hospital.'}, {'ForeName': 'Zhixiong', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Guangdong Medical University.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Ma', 'Affiliation': 'Medical Oncology Department of Thoracic Cancer, Liaoning Cancer Hospital.'}, {'ForeName': 'Minghong', 'Initials': 'M', 'LastName': 'Bi', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Bengbu Medical College.'}, {'ForeName': 'Xiubao', 'Initials': 'X', 'LastName': 'Ren', 'Affiliation': 'Department of Immunology, Tianjin Medical University Cancer Institute and Hospital.'}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University.'}, {'ForeName': 'Baolan', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, Beijing Chest Hospital, Capital Medical University.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Jinling Hospital, The First School of Clinical Medicine, Southern Medical University.'}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Department of Medical Oncology, Jiangsu Cancer Hospital.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, Sichuan Cancer Hospital.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Department of Medical Oncology, Fujian Provincial Cancer Hospital.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiration, Xiangya Second Hospital.'}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, West China Hospital, Sichuan University.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Thoracic Oncology, West China Hospital, Sichuan University.'}, {'ForeName': 'Yingyi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Tumor radiotherapy, The Second Affiliated Hospital of Xingtai Medical College.'}, {'ForeName': 'Nong', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Department of Medical Oncology, Lung Cancer and Gastrointestinal Unit, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology IV, First Hospital of Shijiazhuang.'}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Oncology, The Affiliated Hospital of Qingdao University.'}, {'ForeName': 'Yanqiu', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Internal Medicine, Affiliated Cancer Hospital of Zhengzhou University.'}, {'ForeName': 'Conghua', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': 'Department of Radiation and Medical Oncology, Zhongnan Hospital of Wuhan University.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Medical Oncology, Jilin Cancer Hospital.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Medical science and strategy oncology, Innovent Biologics, Inc.'}, {'ForeName': 'Shuyan', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Medical science and strategy oncology, Innovent Biologics, Inc.'}, {'ForeName': 'Donglei', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': 'Medical science and strategy oncology, Innovent Biologics, Inc.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics and Information, Innovent Biologics, Inc.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Medical Oncology Department, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine. Electronic address: zhangli@sysucc.org.cn.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2020.07.014']
2202,32787905,"Chinese herbal medicine combined with entecavir to reduce the off-therapy recurrence risk in HBeAg-positive chronic hepatitis B patients: a multicener, double-blind, randomized controlled trial in China.","BACKGROUND


Nucleos(t)ide analogues (NAs) are the first-line option against chronic hepatitis B (CHB). NAs produce potent suppression of viral replication with a small chance of HBsAg seroclearance and a high risk of virological relapse after discontinuation. The combined therapy of NAs plus traditional Chinese medicine (TCM) is widely accepted and has been recognized as a prospective alternative approach in China. Based on preliminary works, this study was designed to observe the therapeutic effect of TCM plus entecavir (ETV) against HBeAg-positive chronic hepatitis B with respect to reducing the recurrence risk after NA withdrawal.
METHODS/DESIGN


The study is a nationwide, multicenter, double-blind, randomized, placebo-controlled trial with a duration of 120 weeks. A total of 18 hospitals and 490 eligible Chinese HBeAg-positive CHB patients will be enrolled and randomly allocated into the experimental group and control group in a 1:1 ratio. Patients in the experimental group will be prescribed TCM formulae (Tiaogan-BuXu-Jiedu granules) plus ETV 0.5 mg per day for consolidation therapy for 96 weeks. Patients in the control group will be prescribed TCM granule placebo plus ETV 0.5 mg per day for the same course. After consolidation therapy, all patients will discontinue their trial drugs and be closely monitored over the next 24 weeks. Once clinical recurrence (CR) occurs, ETV treatment will be restarted. The primary outcome is the cumulative rate of CR at the end of this trial.
CONCLUSION


This study is the first of its kind to observe therapeutic effects with respect to reducing recurrence after NA withdrawals after unified integrative consolidation therapy in the CHB population.
TRIAL REGISTRATION


Chinese Clinical Trial Registry No. ChiCTR1900021232 . Registered on February 2, 2019.",2020,NAs produce potent suppression of viral replication with a small chance of HBsAg seroclearance and a high risk of virological relapse after discontinuation.,"['HBeAg-positive chronic hepatitis B patients', 'A total of 18 hospitals and 490 eligible Chinese HBeAg-positive CHB patients']","['Chinese herbal medicine combined with entecavir', 'TCM plus entecavir (ETV', 'NAs plus traditional Chinese medicine (TCM', 'TCM granule placebo plus ETV', 'TCM formulae (Tiaogan-BuXu-Jiedu granules) plus ETV 0.5\u2009mg per day for consolidation therapy', 'placebo']","['cumulative rate of CR', 'virological relapse']","[{'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1579410', 'cui_str': 'Nucleoside analog'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1577184', 'cui_str': 'entecavir 0.5 MG'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",,0.505256,NAs produce potent suppression of viral replication with a small chance of HBsAg seroclearance and a high risk of virological relapse after discontinuation.,"[{'ForeName': 'Xiaoke', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Institute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Ludan', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Institute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Qiu', 'Affiliation': 'Department of Hepatology, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, 518033, Guangdong Province, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Hepatology, Chongqing Traditional Chinese Medicine Hospital, Chongqing, 400021, China.'}, {'ForeName': 'Huanming', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': 'Department of Hepatology, Guangdong Hospital of Traditional Chinese Medicine, Guangzhou, 510006, China.'}, {'ForeName': 'Bingjiu', 'Initials': 'B', 'LastName': 'Lu', 'Affiliation': 'Department of Hepatology, Liaoning Hospital of Traditional Chinese Medicine, Shenyang, 110032, China.'}, {'ForeName': 'Yuyong', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Hepatology, Beijing Ditan Hospital, Beijing, 100015, China.'}, {'ForeName': 'Fuli', 'Initials': 'F', 'LastName': 'Long', 'Affiliation': 'Department of Hepatology, The First Affiliated Hospital of Guangxi University of Chinese Medicine, Nanning, 530023, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Hepatology, Mengchao Hepatobiliary Hospital of Fujian Medical University, Fuzhou, 350025, China.'}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'He', 'Affiliation': ""Department of Hepatology, Shaanxi Hospital of Traditional Chinese Medicine, Xi'an, 710003, China.""}, {'ForeName': 'Qikai', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': ""Department of Hepatology, The Third People's Hospital of Shenzhen, Shenzhen, 518112, Guangdong Province, China.""}, {'ForeName': 'Mingxiang', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Department of Hepatology, The Sixth People's Hospital of Shenyang, Shenyang, 110006, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatology, Public Health Clinical Center of Chengdu, Chengdu, 610066, China.'}, {'ForeName': 'Xiaoning', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Hepatology, Affiliated traditional Chinese Medicine Hospital of Southwest Medical University, Luzhou, 646699, China.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Gong', 'Affiliation': 'Department of Hepatology, 302 Military Hospital of China, Beijing, 100039, China.'}, {'ForeName': 'Xuehua', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Hepatology, Shanghai Shuguang Hospital, Shanghai, 200021, China.'}, {'ForeName': 'Jianguang', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Hepatology, Shandong Hospital of Traditional Chinese Medicine, Jinan, 250011, China.'}, {'ForeName': 'Fengxia', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Department of Hepatology, Beijing Chinese Medicine Hospital, Beijing, 100010, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': ""Department of Hepatology, The Second People's Hospital of Tianjin, Tianjin, 300000, China.""}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Gastroenterology, The Second Hospital of Shandong University, Jinan, 250100, China.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Institute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Institute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Danan', 'Initials': 'D', 'LastName': 'Gan', 'Affiliation': 'Institute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Xianzhao', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Institute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': 'Institute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China. duhongbo@bucm.edu.cn.'}, {'ForeName': ""Yong'an"", 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': 'Institute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China. yeyongan@vip.163.com.'}]",Trials,['10.1186/s13063-020-04417-9']
2203,32787921,A comparison between the effectiveness of a gamified approach with the conventional approach in point-of-care ultrasonographic training.,"BACKGROUND


Although gamification increases user engagement, its effectiveness in point-of-care ultrasonographic training has yet to be fully established. This study was conducted with the primary outcome of evaluating its effectiveness in point-of-care ultrasonographic training as compared to conventional approach.
METHODS


Participants consisting of junior doctors were randomized into either the (1) gamified or the (2) conventional educational approach for ultrasonographic training.
RESULTS


A total of 31 junior doctors participated in this study (16 participants in gamified arm, 15 in the conventional arm after one participant from the conventional arm dropped out due to work commitment). Two-way mixed ANOVA test showed that there was no statistically significant interaction between the types of educational approach and time of testing (pre-test, post-test, 2 months post-training) for both theoretical knowledge score and practical skills score, with F(2, 58) = 39.6, p < 0.001, partial η 2  = 0.4 and F(2, 58) = 3.06, p = 0.06, partial η 2  = 0.095, respectively. For theoretical knowledge score, pairwise comparisons showed that the mean 2 months post-training scores (20.28 +/- 0.70, 95% CI 18.87-21.69) and mean post-test scores (20.27 +/- 0.65, 95% CI 18.94-21.60) were better than the pre-test scores (12.99 +/- 0.50, 95% CI 11.97-14.00) with p-values < 0.001 for both comparisons respectively. Similarly, for practical skill score, pairwise comparisons showed that the mean 2 months post-training scores (20.28 +/- 0.70, 95% CI 18.87-21.69) and mean post-test scores (20.27 +/- 0.65, 95% CI 18.94-21.60) were also better than the pre-test scores (12.99 +/- 0.50, 95% CI 11.97-14.00) with p-values < 0.001 for both comparisons respectively. Participants in the gamification arm generally perceived the various game elements and game mechanics as useful in contributing and motivating them to learn ultrasonography.
CONCLUSIONS


Gamification approach could be an effective alternative to conventional approach in point-of-care ultrasonographic training.",2020,"Participants in the gamification arm generally perceived the various game elements and game mechanics as useful in contributing and motivating them to learn ultrasonography.
","['Participants consisting of junior doctors', '31 junior doctors participated in this study (16 participants in gamified arm, 15 in the conventional arm after one participant from the conventional arm dropped out due to work commitment']","['care ultrasonographic training', 'conventional educational approach for ultrasonographic training']","['mean post-test scores', 'theoretical knowledge score and practical skills score']","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",31.0,0.204273,"Participants in the gamification arm generally perceived the various game elements and game mechanics as useful in contributing and motivating them to learn ultrasonography.
","[{'ForeName': 'Aaron Kuo Huo', 'Initials': 'AKH', 'LastName': 'Lai', 'Affiliation': 'Emergency and Trauma Department, Sarawak General Hospital, 93586, Kuching, Sarawak, Malaysia.'}, {'ForeName': 'Abdul Muhaimin Bin', 'Initials': 'AMB', 'LastName': 'Noor Azhar', 'Affiliation': 'Faculty of Medicine, University of Malaya, Jalan Universiti, Wilayah Persekutuan Kuala Lumpur, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Aidawati Binti', 'Initials': 'AB', 'LastName': 'Bustam', 'Affiliation': 'Faculty of Medicine, University of Malaya, Jalan Universiti, Wilayah Persekutuan Kuala Lumpur, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Xun Ting', 'Initials': 'XT', 'LastName': 'Tiong', 'Affiliation': 'Clinical Research Centre, Sarawak General Hospital, 93586, Kuching, Sarawak, Malaysia.'}, {'ForeName': 'Hiang Chuan', 'Initials': 'HC', 'LastName': 'Chan', 'Affiliation': 'Emergency and Trauma Department, Sarawak General Hospital, 93586, Kuching, Sarawak, Malaysia.'}, {'ForeName': 'Rashidi Bin', 'Initials': 'RB', 'LastName': 'Ahmad', 'Affiliation': 'Faculty of Medicine, University of Malaya, Jalan Universiti, Wilayah Persekutuan Kuala Lumpur, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Keng Sheng', 'Initials': 'KS', 'LastName': 'Chew', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak, Kota Samarahan, 94300, Kuching, Sarawak, Malaysia. kschew@unimas.my.'}]",BMC medical education,['10.1186/s12909-020-02173-7']
2204,32787925,Protocol for the 3HP Options Trial: a hybrid type 3 implementation-effectiveness randomized trial of delivery strategies for short-course tuberculosis preventive therapy among people living with HIV in Uganda.,"BACKGROUND


Recently, a 3-month (12-dose) regimen of weekly isoniazid and rifapentine (3HP) was recommended by the World Health Organization for the prevention of tuberculosis (TB) among people living with HIV (PLHIV) on common antiretroviral therapy regimens. The best approach to delivering 3HP to PLHIV remains uncertain.
METHODS


We developed a three-armed randomized trial assessing optimized strategies for delivering 3HP to PLHIV. The trial will be conducted at the Mulago Immune Suppression Syndrome (i.e., HIV/AIDS) clinic in Kampala, Uganda. We plan to recruit 1656 PLHIV, randomized 1:1 to each of the three arms (552 per arm). Using a hybrid type 3 effectiveness-implementation design, this pragmatic trial aims to (1) compare the acceptance and completion of 3HP among PLHIV under three delivery strategies: directly observed therapy (DOT), self-administered therapy (SAT), and informed patient choice of either DOT or SAT (with the assistance of a decision aid); (2) to identify processes and contextual factors that influence the acceptance and completion of 3HP under each delivery strategy; and (3) to estimate the costs and compare the cost-effectiveness of three strategies for delivering 3HP. The three delivery strategies were each optimized to address key barriers to 3HP completion using a theory-informed approach. We hypothesize that high levels of treatment acceptance and completion can be achieved among PLHIV in sub-Saharan Africa and that offering PLHIV an informed choice between the optimized DOT and SAT delivery strategies will result in greater acceptance and completion of 3HP. The design and planned evaluation of the delivery strategies were guided by the use of implementation science conceptual frameworks.
DISCUSSION


3HP-one of the most promising interventions for TB prevention-will not be scaled up unless it can be delivered in a patient-centered fashion. We highlight shared decision-making as a key element of our trial design and theorize that offering PLHIV an informed choice between optimized delivery strategies will facilitate the highest levels of treatment acceptance and completion.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03934931 ; Registered 2 May 2019.",2020,"The trial will be conducted at the Mulago Immune Suppression Syndrome (i.e., HIV/AIDS) clinic in Kampala, Uganda.","['people living with HIV (PLHIV', 'people living with HIV in Uganda']","['delivery strategies for short-course tuberculosis preventive therapy', 'isoniazid and rifapentine (3HP']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0740413', 'cui_str': 'Tuberculosis prophylaxis'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0073372', 'cui_str': 'rifapentine'}]",[],,0.196427,"The trial will be conducted at the Mulago Immune Suppression Syndrome (i.e., HIV/AIDS) clinic in Kampala, Uganda.","[{'ForeName': 'Jillian L', 'Initials': 'JL', 'LastName': 'Kadota', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine and Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Musinguzi', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Nabunje', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Welishe', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Jackie L', 'Initials': 'JL', 'LastName': 'Ssemata', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Opira', 'Initials': 'O', 'LastName': 'Bishop', 'Affiliation': 'Makerere University Joint AIDS Program, Kampala, Uganda.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Berger', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine and Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Devika', 'Initials': 'D', 'LastName': 'Patel', 'Affiliation': 'Department of Surgery, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Sammann', 'Affiliation': 'Department of Surgery, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Katahoire', 'Affiliation': 'Child Health and Development Centre, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Payam', 'Initials': 'P', 'LastName': 'Nahid', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine and Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Belknap', 'Affiliation': 'Denver Health and Hospital Authority, Denver, CO, USA.'}, {'ForeName': 'Patrick P J', 'Initials': 'PPJ', 'LastName': 'Phillips', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine and Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Namusobya', 'Affiliation': 'University Research Company, Center for Human Services, Department of Defense HIV/AIDS Prevention Program (URC-DHAPP), Kampala, Uganda.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Kamya', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Handley', 'Affiliation': 'Center for Vulnerable Populations at Zuckerberg San Francisco General Hospital and Trauma Center, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Kiwanuka', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Achilles', 'Initials': 'A', 'LastName': 'Katamba', 'Affiliation': 'Department of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dowdy', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Kampala, Uganda.'}, {'ForeName': 'Fred C', 'Initials': 'FC', 'LastName': 'Semitala', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda. semitala@gmail.com.'}, {'ForeName': 'Adithya', 'Initials': 'A', 'LastName': 'Cattamanchi', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine and Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA.'}]",Implementation science : IS,['10.1186/s13012-020-01025-8']
2205,32781913,Effect of shoe cushioning on landing impact forces and spatiotemporal parameters during running: results from a randomized trial including 800+ recreational runners.,"In a recent randomized trial including 800+ recreational runners, injury risk was lower in those who received the Soft shoe version compared to those using the Hard version (Hazard ratio=1.52; 95% Confidence Interval=1.07-2.16). Here, we investigated the effect of shoe cushioning on ground reaction forces (GRF) and spatiotemporal parameters in the same cohort, with a special focus on Vertical Impact Peak Force (VIPF) and Vertical Instantaneous Loading Rate (VILR). Healthy runners (n=848) randomly received one of two shoe prototypes that differed only in their cushioning properties (Global stiffness: 61±3 and 95±6 N/mm in the Soft and Hard versions, respectively). Participants were tested on an instrumented treadmill at their preferred running speed. GRF data was recorded over 2 minutes. VIPF was higher in the Soft shoe group compared to the Hard shoe group (1.53±0.21 vs. 1.44±0.23 BW, respectively; p<0.001). However, the proportion of steps with detectable VIPF was lower in the Soft shoe group (84 vs. 97%, respectively; p<0.001) and Time to VIPF was longer (46.9±8.5 vs. 43.4±7.4 milliseconds, respectively; p<0.001). No significant differences were observed for VILR (60.1±13.8 vs. 58.9±15.6 BW/s for Soft and Hard shoe group, respectively; p=0.070) or any other kinetic variable. These results show that the beneficial effect of greater shoe cushioning on injury risk in the present cohort is not associated with attenuated VIPF and VILR. These GRF metrics may be inappropriate markers of the shoe cushioning-injury risk relationship, while delayed VIPF and the proportion of steps displaying a VIPF could be more relevant. Trial registration: ClinicalTrials.gov identifier: NCT03115437.",2020,"No significant differences were observed for VILR (60.1±13.8 vs. 58.9±15.6 BW/s for Soft and Hard shoe group, respectively; p=0.070) or any other kinetic variable.","['800+ recreational runners', 'Healthy runners (n=848']","['instrumented treadmill at their preferred running speed', 'shoe cushioning']","['proportion of steps with detectable VIPF', 'VILR', 'Vertical Impact Peak Force (VIPF) and Vertical Instantaneous Loading Rate (VILR', 'Time to VIPF', 'VIPF', 'GRF data', 'injury risk']","[{'cui': 'C3844106', 'cui_str': '800'}]","[{'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}]","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0582456', 'cui_str': 'At risk for injury'}]",848.0,0.0967385,"No significant differences were observed for VILR (60.1±13.8 vs. 58.9±15.6 BW/s for Soft and Hard shoe group, respectively; p=0.070) or any other kinetic variable.","[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Malisoux', 'Affiliation': ""Physical Activity, Sport & Health research group, Luxembourg Institute of Health, Luxembourg, 76 rue d'Eich, L-1460 Luxembourg, Grand-Duchy of Luxembourg, laurent.malisoux@lih.lu.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Delattre', 'Affiliation': ""Decathlon Sports Lab, Movement Sciences Department, 4 Boulevard de Mons, 59650 Villeneuve d'Ascq, France, nicolas.delattre@decathlon.com.""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Meyer', 'Affiliation': ""Human motion, Orthopaedic, Sports medicine and Digital methods unit, Luxembourg Institute of Health, Luxembourg, 76 rue d'Eich, L-1460 Luxembourg, Grand-Duchy of Luxembourg, chtitophe@gmail.com; paul.gette@lih.lu.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gette', 'Affiliation': ""Human motion, Orthopaedic, Sports medicine and Digital methods unit, Luxembourg Institute of Health, Luxembourg, 76 rue d'Eich, L-1460 Luxembourg, Grand-Duchy of Luxembourg, chtitophe@gmail.com; paul.gette@lih.lu.""}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Urhausen', 'Affiliation': ""Sports Clinic, Centre Hospitalier de Luxembourg, Luxembourg, 78 rue d'Eich, L-1460 Luxembourg, Grand-Duchy of Luxembourg, urhausen.axel@chl.lu.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Theisen', 'Affiliation': 'ALAN - Maladies Rares Luxembourg, 17 Op Zaemer, L-4959 Bascharage Grand-Duchy of Luxembourg, daniel.theisen@alan.lu.'}]",European journal of sport science,['10.1080/17461391.2020.1809713']
2206,32781920,Effect of ambient temperature on fat oxidation during an incremental cycling exercise test.,"Aim:  The objective of this current research was to compare fat oxidation rates during an incremental cycling exercise test in a temperate vs. hot environment.  Methods:  Twelve healthy young participants were recruited for a randomised crossover experimental design. Each participant performed a VO 2max  test in a thermoneutral environment followed by two cycling ramp test trials, one in a temperate environment (18.3°C) and another in a hot environment (36.3°C). The ramp test consisted of 3-min stages of increasing intensity (+10% of VO 2max ) while gas exchange, heart rate and perceived exertion were measured.  Results:  During exercise, there was a main effect of the environment temperature on fat oxidation rate (F=9.35, P=0.014). The rate of fat oxidation was lower in the heat at 30% VO 2max  (0.42±0.15 vs.0.37±0.13 g/min; P=0.042), 60% VO 2max  (0.37±0.27 vs.0.23±0.23 g/min; P=0.018) and 70% VO 2max  (0.22±0.26 vs.0.12±0.26 g/min; P=0.007). In addition, there was a tendency for a lower maximal fat oxidation rate in the heat (0.55±0.2 vs.0.48±0.2 g/min; P=0.052) and it occurred at a lower exercise intensity (44±14 vs.38±8% VO 2max ; P=0.004). The total amount of fat oxidized was lower in the heat (5.8±2.6 vs 4.6±2.8 g; P=0.002). The ambient temperature also produced main effects on heart rate (F=15.18, P=0.005) and tympanic temperature (F=25.23, P=0.001) with no effect on energy expenditure (F=0.01, P=0.945).  Conclusion:  A hot environment notably reduced fat oxidation rates during a ramp exercise in the heat. Exercise in the heat should not be recommended for those individuals seeking to increase fat oxidation during exercise.",2020,"The ambient temperature also produced main effects on heart rate (F=15.18, P=0.005) and tympanic temperature (F=25.23, P=0.001) with no effect on energy expenditure (F=0.01, P=0.945).  ",['Twelve healthy young participants'],['ambient temperature'],"['total amount of fat oxidized', 'fat oxidation rates', 'tympanic temperature', 'energy expenditure', 'maximal fat oxidation rate', 'heart rate', 'fat oxidation', 'rate of fat oxidation', 'fat oxidation rate']","[{'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0542496', 'cui_str': 'Ambient temperature'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C1532039', 'cui_str': 'Tympanic temperature'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",12.0,0.0585768,"The ambient temperature also produced main effects on heart rate (F=15.18, P=0.005) and tympanic temperature (F=25.23, P=0.001) with no effect on energy expenditure (F=0.01, P=0.945).  ","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ruíz-Moreno', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Gutiérrez-Hellín', 'Affiliation': 'Exercise and Sport Sciences, Faculty of Health Sciences, Francisco de Vitoria University, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'González-García', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Giráldez-Costas', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Diego Brito', 'Initials': 'DB', 'LastName': 'de Souza', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Juan Del', 'Initials': 'JD', 'LastName': 'Coso', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University. Fuenlabrada, Spain.'}]",European journal of sport science,['10.1080/17461391.2020.1809715']
2207,32781939,Electroanalgesia during a carboxytherapy procedure for cellulite: a study protocol for a randomized controlled trial.,"The aim of the present study is to describe a study protocol to compare different types of analgesic electrical currents on pain intensity and sensory comfort during the application of carboxytherapy for the treatment of cellulite. Seventy five women with the presence of moderate and/or severe gluteal cellulite will be randomly allocated into three groups: carboxytherapy plus transcutaneous electrical nerve stimulation, carboxytherapy plus interferential current or carboxytherapy plus Aussie current. Pain intensity, which is the primary outcome, will be measured by a numeric rating scale (0-10). The secondary outcome is sensory comfort, which will be measured using the visual analogue scale (0-10). Trial registration: Brazilian Clinical Trials Registry: ReBEC (RBR-6z82zb) www.ensaiosclinicos.gov.br/rg/RBR-6z82zb/.",2020,www.ensaiosclinicos.gov.br/rg/RBR-6z82zb/.,"['five women with the presence of moderate and/or severe gluteal cellulite', 'Seventy']","['analgesic electrical currents', 'carboxytherapy', 'Electroanalgesia', 'carboxytherapy plus transcutaneous electrical nerve stimulation, carboxytherapy plus interferential current\xa0or carboxytherapy plus Aussie current', 'ReBEC (RBR-6z82zb', 'www.ensaiosclinicos.gov.br/rg/RBR-6z82zb']","['pain intensity and sensory comfort', 'Pain intensity', 'sensory comfort, which will be measured using the visual analogue scale']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0424624', 'cui_str': 'Fatty dimpling of skin'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1522015', 'cui_str': 'Electroanalgesia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",75.0,0.126507,www.ensaiosclinicos.gov.br/rg/RBR-6z82zb/.,"[{'ForeName': 'Adria Yared', 'Initials': 'AY', 'LastName': 'Sadala', 'Affiliation': 'Physioterapeutics Resources Laboratory, Department of Physical Therapy, Federal University of São Carlos (UFSCar), Rod. Washington Luis, km 235, São Carlos/SP, Brazil.'}, {'ForeName': 'Érika Patrícia', 'Initials': 'ÉP', 'LastName': 'Rampazo da Silva', 'Affiliation': 'Physioterapeutics Resources Laboratory, Department of Physical Therapy, Federal University of São Carlos (UFSCar), Rod. Washington Luis, km 235, São Carlos/SP, Brazil.'}, {'ForeName': 'Richard Eloin', 'Initials': 'RE', 'LastName': 'Liebano', 'Affiliation': 'Physioterapeutics Resources Laboratory, Department of Physical Therapy, Federal University of São Carlos (UFSCar), Rod. Washington Luis, km 235, São Carlos/SP, Brazil.'}]",Pain management,['10.2217/pmt-2020-0003']
2208,32781940,Effects of Inhibition of Nitric Oxide Synthase on Muscular Arteries During Exercise: Nitric Oxide Does Not Contribute to Vasodilation During Exercise or in Recovery.,"Background Basal release of nitric oxide (NO) from the vascular endothelium regulates the tone of muscular arteries and resistance vasculature. Effects of NO on muscular arteries could be particularly important during exercise when shear stress may stimulate increased NO synthesis. Methods and Results We investigated acute effects of NO synthase inhibition on exercise hemodynamics using N G -monomethyl-l-arginine (l-NMMA), a nonselective NO synthase -inhibitor. Healthy volunteers (n=10, 5 female, 19-33 years) participated in a 2-phase randomized crossover study, receiving l-NMMA (6 mg/kg, iv over 5 minutes) or placebo before bicycle exercise (25-150 W for 12 minutes). Blood pressure, cardiac output (measured by dilution of soluble and inert tracers) and femoral artery diameter were measured before, during, and after exercise. At rest, l-NMMA reduced heart rate (by 16.2±4.3 bpm relative to placebo,  P <0.01), increased peripheral vascular resistance (by 7.0±1.4 mmHg per L/min,  P <0.001), mean arterial blood pressure (by 8.9±3.5 mmHg,  P <0.05), and blunted an increase in femoral artery diameter that occurred immediately before exercise (change in diameter: 0.14±0.04 versus 0.32±0.06 mm after l-NMMA and placebo,  P <0.01). During/after exercise l-NMMA had no significant effect on peripheral resistance, cardiac output, or on femoral artery diameter. Conclusions These results suggest that NO plays little role in modulating muscular artery function during exercise but that it may mediate changes in muscular artery tone immediately before exercise.",2020,"At rest, l-NMMA reduced heart rate (by 16.2±4.3 bpm relative to placebo,  P <0.01), increased peripheral vascular resistance (by 7.0±1.4 mmHg per L/min,  P <0.001), mean arterial blood pressure (by 8.9±3.5 mmHg,  P <0.05), and blunted an increase in femoral artery diameter that occurred immediately before exercise (change in diameter: 0.14±0.04 versus 0.32±0.06 mm after l-NMMA and placebo,  P <0.01).","['Muscular Arteries', 'Healthy volunteers (n=10, 5 female, 19-33\xa0years']","['receiving l-NMMA', 'N G -monomethyl-l-arginine (l-NMMA', 'NO synthase inhibition', 'nitric oxide (NO', 'Nitric Oxide Synthase', 'placebo before bicycle exercise']","['peripheral resistance, cardiac output, or on femoral artery diameter', 'femoral artery diameter', 'Blood pressure, cardiac output (measured by dilution of soluble and inert tracers) and femoral artery diameter', 'heart rate', 'peripheral vascular resistance', 'mean arterial blood pressure']","[{'cui': 'C0226002', 'cui_str': 'Structure of medium artery'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0069477', 'cui_str': 'NG-Monomethyl-L-Arginine'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0132555', 'cui_str': 'Nitric-oxide synthase'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0079240', 'cui_str': 'Dilution'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",,0.205493,"At rest, l-NMMA reduced heart rate (by 16.2±4.3 bpm relative to placebo,  P <0.01), increased peripheral vascular resistance (by 7.0±1.4 mmHg per L/min,  P <0.001), mean arterial blood pressure (by 8.9±3.5 mmHg,  P <0.05), and blunted an increase in femoral artery diameter that occurred immediately before exercise (change in diameter: 0.14±0.04 versus 0.32±0.06 mm after l-NMMA and placebo,  P <0.01).","[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': ""O'Gallagher"", 'Affiliation': ""Cardiovascular Division Department of Clinical Pharmacology King's College London School of Medicine St Thomas' Hospital London United Kingdom.""}, {'ForeName': 'Husain', 'Initials': 'H', 'LastName': 'Shabeeh', 'Affiliation': ""Cardiovascular Division Department of Clinical Pharmacology King's College London School of Medicine St Thomas' Hospital London United Kingdom.""}, {'ForeName': 'Shahzad', 'Initials': 'S', 'LastName': 'Munir', 'Affiliation': ""Cardiovascular Division Department of Clinical Pharmacology King's College London School of Medicine St Thomas' Hospital London United Kingdom.""}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Roomi', 'Affiliation': ""Cardiovascular Division Department of Clinical Pharmacology King's College London School of Medicine St Thomas' Hospital London United Kingdom.""}, {'ForeName': 'Benyu', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': ""Cardiovascular Division Department of Clinical Pharmacology King's College London School of Medicine St Thomas' Hospital London United Kingdom.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Guilcher', 'Affiliation': ""Cardiovascular Division Department of Clinical Pharmacology King's College London School of Medicine St Thomas' Hospital London United Kingdom.""}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Brett', 'Affiliation': ""Cardiovascular Division Department of Clinical Pharmacology King's College London School of Medicine St Thomas' Hospital London United Kingdom.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Chowienczyk', 'Affiliation': ""Cardiovascular Division Department of Clinical Pharmacology King's College London School of Medicine St Thomas' Hospital London United Kingdom.""}]",Journal of the American Heart Association,['10.1161/JAHA.119.013849']
2209,32781987,Cost-effectiveness of the PDSAFE personalised physiotherapy intervention for fall prevention in Parkinson's: an economic evaluation alongside a randomised controlled trial.,"BACKGROUND


PDSAFE is an individually-tailored, physiotherapist-delivered, balance, strength and strategy training programme aimed at preventing falls among people with Parkinson's. We evaluated the cost-effectiveness of PDSAFE compared with usual care for people with Parkinson's at higher risk of falling, from a UK National Health Service and Personal Social Service perspective.
METHODS


Resource use and quality of life data (EQ-5D-3L) were collected from 238 participants randomised to the PDSAFE intervention and 236 participants randomised to control, at baseline, 3 months, 6 months (primary outcome), and 12 months. Adjusted cost and quality-adjusted life-years (QALYs) were estimated using generalised linear models and uncertainty estimated using a non-parametric bootstrap.
RESULTS


Over 6 months, the PDSAFE intervention was associated with an incremental cost of £925 (95% CI £428 to £1422) and a very small and statistically insignificant QALY gain of 0.008 (95% CI - 0.006 to 0.021). The resulting incremental cost-effectiveness ratio (ICER) was £120,659 per QALY and the probability of the intervention being cost-effective at a UK threshold of £30,000/QALY was less than 1%. The ICER varied substantially across subgroups although no subgroup had an ICER lower than the £30,000 threshold. The result was sensitive to the time horizon with the ICER reducing to £55,176 per QALY when adopting a 12-month time horizon and assuming a sustained treatment effect on QoL, nevertheless, the intervention was still not cost-effective according to the current UK threshold.
CONCLUSIONS


Evidence from this trial suggests that the PDSAFE intervention is unlikely to be cost-effective at 6 months. The 12-month analysis suggested that the intervention became closer to being cost-effective if quality of life effects were sustained beyond the intervention period, however this would require confirmation. Further research, including qualitative studies, should be conducted to better understand the treatment effect of physiotherapy and its impact on quality of life in people with Parkinson's given existing mixed evidence on this topic.
TRIAL REGISTRATION


ISRCTN48152791. Registered 17 April 2014. http://www.isrctn.com/ISRCTN48152791.",2020,"The 12-month analysis suggested that the intervention became closer to being cost-effective if quality of life effects were sustained beyond the intervention period, however this would require confirmation.","['238 participants randomised to the', ""Parkinson's"", ""people with Parkinson's at higher risk of falling, from a UK National Health Service and Personal Social Service perspective"", ""people with Parkinson's""]","['PDSAFE intervention', 'PDSAFE personalised physiotherapy intervention', 'PDSAFE']","['Cost-effectiveness', 'Adjusted cost and quality-adjusted life-years (QALYs', 'ICER', 'quality of life data (EQ-5D-3L', 'incremental cost', 'QALY gain', 'cost-effectiveness', 'incremental cost-effectiveness ratio (ICER']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.105511,"The 12-month analysis suggested that the intervention became closer to being cost-effective if quality of life effects were sustained beyond the intervention period, however this would require confirmation.","[{'ForeName': 'Yiqiao', 'Initials': 'Y', 'LastName': 'Xin', 'Affiliation': 'Health Economics and Health Technology Assessment (HEHTA), Institute of Health & Wellbeing, University of Glasgow, 1 Lilybank gardens, Glasgow, G12 8RZ, UK.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Ashburn', 'Affiliation': 'School of Health Science, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ruth M', 'Initials': 'RM', 'LastName': 'Pickering', 'Affiliation': 'Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Kim Chivers', 'Initials': 'KC', 'LastName': 'Seymour', 'Affiliation': 'School of Health Science, University of Southampton, Southampton, UK.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Hulbert', 'Affiliation': 'School of Health Science, University of Southampton, Southampton, UK.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Fitton', 'Affiliation': 'School of Health Science, University of Southampton, Southampton, UK.'}, {'ForeName': 'Dorit', 'Initials': 'D', 'LastName': 'Kunkel', 'Affiliation': 'School of Health Science, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ioana', 'Initials': 'I', 'LastName': 'Marian', 'Affiliation': 'Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Helen C', 'Initials': 'HC', 'LastName': 'Roberts', 'Affiliation': 'Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Centre for Statistics in Medicine, Oxford Clinical Trials Research Unit (OCTRU), University of Oxford, Oxford, UK.'}, {'ForeName': 'Victoria A', 'Initials': 'VA', 'LastName': 'Goodwin', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Rochester', 'Affiliation': 'Clinical Ageing Research Unit, Institute of Neuroscience, Newcastle University, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'McIntosh', 'Affiliation': 'Health Economics and Health Technology Assessment (HEHTA), Institute of Health & Wellbeing, University of Glasgow, 1 Lilybank gardens, Glasgow, G12 8RZ, UK. Emma.McIntosh@glasgow.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC neurology,['10.1186/s12883-020-01852-8']
2210,32781991,Correction to: Effectiveness of a theory-based back care intervention on spine-related behavior among pupils: a school-based randomised controlled trial (T-Bak study).,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['spine-related behavior among pupils'],['theory-based back care intervention'],[],"[{'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0204750', 'cui_str': 'Special back care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.029166,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Akbari-Chehrehbargh', 'Affiliation': 'Department of Health Education, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Sedigheh Sadat', 'Initials': 'SS', 'LastName': 'Tavafian', 'Affiliation': 'Department of Health Education, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran. Tavafian@modares.ac.ir.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Montazeri', 'Affiliation': 'Health Metrics Research Center, Iranian Institutes for Health Sciences Research, ACECR, Tehran, Iran. montazeri@acecr.ac.ir.'}]",BMC public health,['10.1186/s12889-020-09200-8']
2211,32781992,A short course of oral ranitidine as a novel treatment for toddler's diarrhea: a parallel-group randomized controlled trial.,"BACKGROUND


The current paradigm for treating toddler's diarrhea comprises dietary modification and fluid restriction. Previous studies show that probiotics and proton-pump inhibitors (PPIs) or H 2  blockers could control diarrhea associated with functional gastrointestinal disorders (FGIDs). This study aims to determine and compare the efficacy of a short course of oral ranitidine and a probiotic in the treatment of toddler's diarrhea.
METHODS


This study was a parallel-group randomized controlled trial (RCT). We sequentially enrolled 40 patients who met the eligibility criteria. We randomly assigned 20 patients to the oral ranitidine group, ten patients to the probiotic group, and ten patients to the placebo group. In the oral ranitidine group, patients received oral ranitidine (3 mg/kg/day) once daily for 10 days; in the probiotic and placebo groups, they were administered 5 to 10 billion colony-forming units (CFUs) per day of lyophilized Lactobacillus rhamnosus and 50 mg of once-daily oral vitamin C tablet respectively for 10 days. Stool frequency and consistency on the 10th day of the interventions were recorded as the primary outcomes. We used the Student's t-test to determine if there were significant differences in the mean daily stool frequencies in the three intervention groups. A p-value < 0.05 was adopted as the level of statistical significance.
RESULTS


In the ranitidine group, stool frequency decreased significantly from an average of five per day on the first day to an average of approximately one per day on the 10th day of intervention (t = 10.462, p <  0.001). Additionally, stool consistency normalized on the 10th day of intervention. In the probiotic group, there was a significant reduction in stool frequency from an average of five per day on the first day to four per day on the 10th day (t = 2.586, p = 0.041), although stool consistency remained loose. However, stool consistency and frequency were not significantly affected in the placebo group (t = 1.964, p = 0.072).
CONCLUSION


Oral ranitidine is more effective than probiotics in reducing stool frequency and normalizing stool consistency in toddler's diarrhea. We recommend multi-center trials with appropriate study designs to confirm and validate this finding.
TRIAL REGISTRATION


ISRCTN, ISRCTN10783996 . Registered 8 April 2016-Registered retrospectively.",2020,"However, stool consistency and frequency were not significantly affected in the placebo group (t = 1.964, p = 0.072).
","[""toddler's diarrhea"", '40 patients who met the eligibility criteria']","['oral ranitidine', 'lyophilized Lactobacillus rhamnosus and 50\u2009mg of once-daily oral vitamin C tablet', 'probiotics and proton-pump inhibitors (PPIs', 'probiotic and placebo', 'ranitidine', 'placebo']","['stool frequency', 'stool consistency and frequency', 'mean daily stool frequencies', 'Stool frequency and consistency', 'stool frequency and normalizing stool consistency']","[{'cui': 'C0473132', 'cui_str': 'Toddler diarrhea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0034665', 'cui_str': 'Ranitidine'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]",40.0,0.0825863,"However, stool consistency and frequency were not significantly affected in the placebo group (t = 1.964, p = 0.072).
","[{'ForeName': 'Samuel N', 'Initials': 'SN', 'LastName': 'Uwaezuoke', 'Affiliation': 'Department of Pediatrics, University of Nigeria of Nigeria Teaching Hospital Ituku-Ozalla Enugu/College of Medicine, University of Nigeria Enugu Campus, Enugu, Nigeria. snuwaezuoke@yahoo.com.'}, {'ForeName': 'Ikenna K', 'Initials': 'IK', 'LastName': 'Ndu', 'Affiliation': 'Department of Pediatrics, Enugu State University Teaching Hospital, Parklane, Enugu, Nigeria.'}, {'ForeName': 'Chizoma I', 'Initials': 'CI', 'LastName': 'Eneh', 'Affiliation': 'Department of Pediatrics, Enugu State University Teaching Hospital, Parklane, Enugu, Nigeria.'}, {'ForeName': 'Chikere A', 'Initials': 'CA', 'LastName': 'Anusiem', 'Affiliation': 'Department of Pharmacology and Therapeutics, College of Medicine, University of Nigeria Enugu Campus, Enugu, Nigeria.'}, {'ForeName': 'Adaeze C', 'Initials': 'AC', 'LastName': 'Ayuk', 'Affiliation': 'Department of Pediatrics, University of Nigeria of Nigeria Teaching Hospital Ituku-Ozalla Enugu/College of Medicine, University of Nigeria Enugu Campus, Enugu, Nigeria.'}]",BMC pediatrics,['10.1186/s12887-020-02267-7']
2212,32782008,Predictors of low back disability in chiropractic and physical therapy settings.,"BACKGROUND


Predicting ongoing disability for chronic non-specific low back pain (LBP) is important to avoid prolonged disability.
OBJECTIVE


Determine predictors of disability at 6 month follow-up in patients with LBP at medium risk of ongoing disability.
METHODS


Baseline data was collected from 108 patients with medium-risk chronic non-specific LBP (mean age 50.4 years, SD 13.6) from six private chiropractic and physiotherapy clinics in Australia who took part in a randomised control trial. All patients received a pragmatic course of multimodal physical treatments [e.g., manual therapy (spinal manipulation or mobilization and/or soft tissue massage)] combined with advice, education and exercise. Baseline prognostic variables included sociodemographic, physical and psychological characteristics. Primary outcome was disability (Roland Morris Disability) at 6 month follow-up. Multivariable linear regression analysis was conducted.
RESULTS


Variables remaining in the final multivariable model: lower work ability (β = - 1.05, 95% CI - 1.40 to - 0.70; p < 0.0001) and consultation with a medical specialist for back pain in the preceding 3 months (β = 3.35, 95% CI 1.14 to 5.55; p < 0.003), which significantly predicted higher disability at 6 months (unadjusted R  2  = 0.31). Those with a lower work ability (scale 1 to 10) and who had seen a medical specialist for their back pain were more likely to report greater LBP-related disability at 6 months.
CONCLUSION


Patients with chronic LBP presenting to primary care with lower work ability and recent consultation with a medical specialist for LBP are more likely to have a worse prognosis; these are indicators to clinicians that standard conservative care may not adequately manage the patients' needs.",2020,"RESULTS


Variables remaining in the final multivariable model: lower work ability (β = - 1.05, 95% CI - 1.40 to - 0.70;","['patients with LBP at medium risk of ongoing disability', 'Patients with chronic LBP presenting to primary care with lower work ability and recent consultation with a medical specialist for LBP', '108 patients with medium-risk chronic non-specific LBP (mean age 50.4\u2009years, SD 13.6) from six private chiropractic and physiotherapy clinics in Australia who took part in a randomised control trial']","['multimodal physical treatments [e.g., manual therapy (spinal manipulation or mobilization and/or soft tissue massage)] combined with advice, education and exercise']","['sociodemographic, physical and psychological characteristics', 'consultation with a medical specialist for back pain', 'disability (Roland Morris Disability', 'disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0008138', 'cui_str': 'Chiropractic'}, {'cui': 'C3839152', 'cui_str': 'Physiotherapy clinic'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0556852', 'cui_str': 'Soft tissue massage'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",108.0,0.0812215,"RESULTS


Variables remaining in the final multivariable model: lower work ability (β = - 1.05, 95% CI - 1.40 to - 0.70;","[{'ForeName': 'M John', 'Initials': 'MJ', 'LastName': 'Petrozzi', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Rm S223, S Block, Sydney School of Health Sciences, Cumberland Campus NSW, Sydney, 2141, Australia. mpet9893@uni.sydney.edu.au.'}, {'ForeName': 'Sidney M', 'Initials': 'SM', 'LastName': 'Rubinstein', 'Affiliation': 'Department of Health Sciences, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Paulo H', 'Initials': 'PH', 'LastName': 'Ferreira', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Rm S223, S Block, Sydney School of Health Sciences, Cumberland Campus NSW, Sydney, 2141, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Leaver', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Rm S223, S Block, Sydney School of Health Sciences, Cumberland Campus NSW, Sydney, 2141, Australia.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Mackey', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Rm S223, S Block, Sydney School of Health Sciences, Cumberland Campus NSW, Sydney, 2141, Australia.'}]",Chiropractic & manual therapies,['10.1186/s12998-020-00328-3']
2213,32782010,"The effects of spinach-derived thylakoid supplementation in combination with calorie restriction on anthropometric parameters and metabolic profiles in obese women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled clinical trial.","BACKGROUND


There is a promising outlook regarding the potential effect of spinach-derived thylakoids in the management of obesity and its associated metabolic disturbances. This research aimed to evaluate the effects of spinach-derived thylakoids supplementation combined with a calorie-restricted diet on anthropometric and metabolic profiles in obese women with the polycystic ovary syndrome (PCOS).
METHODS


In a 12-week double-blind placebo-controlled randomized clinical trial, 48 females with obesity and PCOS were randomly allocated into either intervention (5 g/day thylakoid) or placebo (5 g/day cornstarch) groups along with calorie-restricted diets. Anthropometric measures, physical activity levels, dietary intakes, insulin resistance markers, as well as serum levels of insulin, fasting blood glucose (FBG), non-esterified fatty acids (NEFA), and sex hormones including dehydroepiandrosterone sulfate (DHEAS), follicle-stimulating hormone (FSH), luteinizing hormone (LH), sex hormone-binding globulin (SHBG), and free androgen index (FAI) were evaluated pre-and post-intervention.
RESULTS


After the 12-week intervention, there were significant decreases in weight (- 6.97 ± 0.52 vs. -3.19 ± 0.72 kg; P < 0.001), waist circumference (- 7.78 ± 2.50 vs. -3.73 ± 1.40 cm; P < 0.001), fat mass (- 5.19 ± 0.53 vs. -1.36 ± 0.39 kg; P < 0.001), and insulin levels (- 5.40 ± 1.86 vs. -1.19 ± 0.85 μU/mL; P < 0.001) in the spinach-derived thylakoid group compared to the placebo group. Furthermore, insulin resistance markers and serum levels of testosterone decreased significantly in the thylakoid group compared to the placebo group (P < 0.05). The changes in other parameters did not show significant differences between the two groups.
CONCLUSIONS


Spinach-derived thylakoid supplementation resulted in more favorable improvements in anthropometric indices and insulin sensitivity compared to the calorie restriction alone.
TRIAL REGISTRATION


The study was approved by the Ethics Committee of Research Vice-chancellor of Tabriz University of Medical Sciences, Tabriz, Iran, and was registered in the Iranian Registry of Clinical Trials (registration ID: IRCT20140907019082N9 ).",2020,"Furthermore, insulin resistance markers and serum levels of testosterone decreased significantly in the thylakoid group compared to the placebo group (P < 0.05).","['obese women with polycystic ovary syndrome', 'obese women with the polycystic ovary syndrome (PCOS', '48 females with obesity and PCOS']","['calorie restriction', 'spinach-derived thylakoid supplementation', 'Spinach-derived thylakoid supplementation', 'spinach-derived thylakoids supplementation combined with a calorie-restricted diet', 'calorie-restricted diets', 'placebo']","['weight', 'waist circumference', 'anthropometric indices and insulin sensitivity', 'Furthermore, insulin resistance markers and serum levels of testosterone', 'anthropometric parameters and metabolic profiles', 'fat mass', 'Anthropometric measures, physical activity levels, dietary intakes, insulin resistance markers, as well as serum levels of insulin, fasting blood glucose (FBG), non-esterified fatty acids (NEFA), and sex hormones including dehydroepiandrosterone sulfate (DHEAS), follicle-stimulating hormone (FSH), luteinizing hormone (LH), sex hormone-binding globulin (SHBG), and free androgen index (FAI', 'insulin levels']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0242949', 'cui_str': 'Spinach'}, {'cui': 'C1879336', 'cui_str': 'Thylakoids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}, {'cui': 'C0036884', 'cui_str': 'Sex hormone'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0057277', 'cui_str': 'Dehydroepiandrosterone sulfate'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}]",48.0,0.696044,"Furthermore, insulin resistance markers and serum levels of testosterone decreased significantly in the thylakoid group compared to the placebo group (P < 0.05).","[{'ForeName': 'Fatemeh Pourteymour Fard', 'Initials': 'FPF', 'LastName': 'Tabrizi', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mahdieh Abbasalizad', 'Initials': 'MA', 'LastName': 'Farhangi', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Attar-neishabouri Ave, Golgasht St, Tabriz, 5165665931, Iran. abbasalizad_m@yahoo.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Vaezi', 'Affiliation': ""Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Salar', 'Initials': 'S', 'LastName': 'Hemmati', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Nutrition journal,['10.1186/s12937-020-00601-4']
2214,32782076,Effects of Peppermint Aromatherapy on Postoperative Nausea and Vomiting.,"PURPOSE


Standardized order sets for postoperative patients often include antiemetic medications only for postoperative nausea and vomiting (PONV). The purpose of this study was to compare the incidence of PONV in patients receiving peppermint aromatherapy and usual care to patients receiving only usual care.
DESIGN


Quasi-experimental research design used to evaluate the ability of peppermint aromatherapy to decrease PONV and antiemetic use postoperatively.
METHODS


Intervention group received peppermint aromatherapy with a control group receiving standard of care. The nausea scale with descriptors was used to evaluate PONV.
FINDINGS


Descriptive statistics and a χ 2  test revealed no statistical significance (P = .28). However, peppermint aromatherapy was preferred by many patients as indicated by patients' statements and decreased ratings and complaints of nausea.
CONCLUSIONS


The peppermint aromatherapy was favorably received by many of the postoperative patients and may be an effective adjunct treatment with antiemetics for PONV.",2020,The peppermint aromatherapy was favorably received by many of the postoperative patients and may be an effective adjunct treatment with antiemetics for PONV.,"['patients receiving peppermint aromatherapy and usual care to patients receiving only usual care', 'postoperative patients often include antiemetic medications only for postoperative nausea and vomiting (PONV']","['Peppermint Aromatherapy', 'peppermint aromatherapy', 'peppermint aromatherapy with a control group receiving standard of care']","['Postoperative Nausea and Vomiting', 'incidence of PONV', 'nausea scale', 'ratings and complaints of nausea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0070324', 'cui_str': 'Peppermint preparation'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}]","[{'cui': 'C0070324', 'cui_str': 'Peppermint preparation'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}]",,0.0157734,The peppermint aromatherapy was favorably received by many of the postoperative patients and may be an effective adjunct treatment with antiemetics for PONV.,"[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Karsten', 'Affiliation': 'Postanesthesia Care Unit, University of Texas Medical Branch, Galveston, TX. Electronic address: mskarste@utmb.edu.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Prince', 'Affiliation': 'Postanesthesia Care Unit, University of Texas Medical Branch, Galveston, TX.'}, {'ForeName': 'Ruthie', 'Initials': 'R', 'LastName': 'Robinson', 'Affiliation': 'School of Nursing, Lamar Univerisity, Beaumont.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Stout-Aguilar', 'Affiliation': 'Postanesthesia Care Unit, University of Texas Medical Branch, Galveston, TX.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2020.03.018']
2215,32782323,The effect of umbilical cord milking on cerebral blood flow in very preterm infants: a randomized controlled study.,"OBJECTIVE


To compare the effect of umbilical cord milking (UCM) vs. early cord clamping (ECC) on cerebral blood flow (CBF).
METHOD


Preterm infants <31 weeks' gestation were randomized to receive UCM or ECC at birth. Blood flow velocities and resistive & pulsatility indices of middle and anterior cerebral arteries were measured at 4-6 and 10-12 h after birth as an estimate of CBF.
RESULTS


Randomization allocated 37 infants to UCM and 36 to ECC. Maternal and antenatal variables were similar. There were no significant differences between groups in middle or anterior CBF velocities and resistive indices at either study time point. CBF variables were not correlated with mean blood pressure, systemic blood flow, or intraventricular hemorrhage.
CONCLUSIONS


In very preterm infants, UCM compared with ECC was not shown to change CBF indices during the first 12 h of age or correlate with other hemodynamic measures or with intraventricular hemorrhage.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT01487187.",2020,"In very preterm infants, UCM compared with ECC was not shown to change CBF indices during the first 12 h of age or correlate with other hemodynamic measures or with intraventricular hemorrhage.
","['very preterm infants', ""Preterm infants <31 weeks' gestation""]","['umbilical cord milking (UCM) vs. early cord clamping (ECC', 'ECC', 'UCM or ECC', 'umbilical cord milking']","['middle or anterior CBF velocities and resistive indices', 'cerebral blood flow', 'change CBF indices', 'mean blood pressure, systemic blood flow, or intraventricular hemorrhage', 'cerebral blood flow (CBF', 'Blood flow velocities and resistive & pulsatility indices of middle and anterior cerebral arteries']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]","[{'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0149561', 'cui_str': 'Structure of anterior cerebral artery'}]",37.0,0.23997,"In very preterm infants, UCM compared with ECC was not shown to change CBF indices during the first 12 h of age or correlate with other hemodynamic measures or with intraventricular hemorrhage.
","[{'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'El-Naggar', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, Dalhousie University, Halifax, Canada. walid.el-naggar@iwk.nshealth.ca.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'McMillan', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Hussain', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Armson', 'Affiliation': 'Department of Obstetrics & Gynecology, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Warren', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Whyte', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simpson', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, Dalhousie University, Halifax, Canada.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-00780-2']
2216,32782361,RCT of group versus individual PFMT.,,2020,,[],['RCT of group versus individual PFMT'],[],[],"[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],,0.0180887,,"[{'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Fenner', 'Affiliation': 'Nature Reviews Urology, . nruro@nature.com.'}]",Nature reviews. Urology,['10.1038/s41585-020-0367-z']
2217,32782462,Evaluating the clinical and cost-effectiveness of permissive hypotension in critically ill patients aged 65 years or over with vasodilatory hypotension: Statistical and health economic analysis plan for the 65 trial in article.,"The 65 trial is a pragmatic, multicentre, parallel-group, open-label, randomised clinical trial of permissive hypotension (targeting a mean arterial pressure target of 60-65 mmHg during vasopressor therapy) versus usual care in critically ill patients aged 65 years or over with vasodilatory hypotension. The trial will recruit 2600 patients from 65 United Kingdom adult general critical care units. The primary outcome is all-cause mortality at 90 days. An economic evaluation is embedded. This paper describes the proposed statistical and health economic analysis for the 65 trial.",2020,"The 65 trial is a pragmatic, multicentre, parallel-group, open-label, randomised clinical trial of permissive hypotension (targeting a mean arterial pressure target of 60-65 mmHg during vasopressor therapy) versus usual care in critically ill patients aged 65 years or over with vasodilatory hypotension.","['2600 patients from 65 United Kingdom adult general critical care units', 'critically ill patients aged 65 years or over with vasodilatory hypotension']","['permissive hypotension', 'permissive hypotension (targeting a mean arterial pressure target of 60-65 mmHg during vasopressor therapy']",['cause mortality'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",2600.0,0.27535,"The 65 trial is a pragmatic, multicentre, parallel-group, open-label, randomised clinical trial of permissive hypotension (targeting a mean arterial pressure target of 60-65 mmHg during vasopressor therapy) versus usual care in critically ill patients aged 65 years or over with vasodilatory hypotension.","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), London, UK.'}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), London, UK.'}, {'ForeName': 'M Zia', 'Initials': 'MZ', 'LastName': 'Sadique', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Grieve', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Alexina J', 'Initials': 'AJ', 'LastName': 'Mason', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Moler', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Gordon', 'Affiliation': 'Section of Anaesthetics, Pain Medicine & Intensive Care, Imperial College London, London, UK.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Rowan', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), London, UK.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Mouncey', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), London, UK.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Lamontagne', 'Affiliation': 'Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke et Faculté de médecine et des sciences de la santé, Université de Sherbrooke, Sherbrooke, Canada.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Harrison', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), London, UK.'}]",Journal of the Intensive Care Society,['10.1177/1751143720938894']
2218,32782482,Improved urinary melatonin level as the perspective indicator that leads to better sleeping quality in bladder cancer patients.,"Background


Individuals with higher-than-average melatonin concentrations are less likely to develop cancer. In cancer patients, psychosomatic coping patterns and treatment side effects are important indicators of cancer prevention and immune system deterioration. This study focused on changes in the urinary melatonin concentration, life resilience, and sleep quality in bladder cancer patients before, and 3 months after, treatment.
Methods


A controlled before-and-after study was performed. The subjects were patients who were previously diagnosed with bladder cancer and had received treatment (transurethral resection of bladder tumor + intravesical chemotherapy). Data from 23 subjects were analyzed.
Results


The results showed a significant difference in the melatonin concentration before and after treatment (Wilcoxon signed-rank test,  Z  = -2.220,  p  = 0.026). The melatonin concentration in 16 patients (70%) increased after treatment. The mean Pittsburgh Sleep Quality Index (PSQI) score before treatment was 7.348 (SD = 4.030), which was associated with poor sleep quality. The mean PSQI score after treatment was 6.435 (SD = 3.300;  Z  = -2.071;  p  = 0.038). These results represent the improved sleep quality in patients post-treatment.
Conclusions


After treatment, the urinary melatonin concentration and sleep quality (PSQI) improved, both of which were statistically significant in bladder cancer patients. Consequently, bladder cancer treatment should be initiated as soon as possible. There was no significant difference in overall life resilience before and after treatment, possibly because elderly individuals have strong personality traits and emotional stability and are not easily affected by life events or stress.",2020,"After treatment, the urinary melatonin concentration and sleep quality (PSQI) improved, both of which were statistically significant in bladder cancer patients.","['subjects were patients who were previously diagnosed with bladder cancer and had received', 'bladder cancer patients', '23 subjects were analyzed', 'bladder cancer patients before, and 3\u2009months after, treatment']",['treatment (transurethral resection of bladder tumor\u2009+\u2009intravesical chemotherapy'],"['poor sleep quality', 'urinary melatonin level', 'mean PSQI score', 'mean Pittsburgh Sleep Quality Index (PSQI) score', 'melatonin concentration', 'overall life resilience', 'urinary melatonin concentration and sleep quality (PSQI', 'urinary melatonin concentration, life resilience, and sleep quality', 'sleep quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",23.0,0.0639067,"After treatment, the urinary melatonin concentration and sleep quality (PSQI) improved, both of which were statistically significant in bladder cancer patients.","[{'ForeName': 'Tse-Chou', 'Initials': 'TC', 'LastName': 'Cheng', 'Affiliation': 'Department of Urology, Chi Mei Medical Center, Tainan City.'}, {'ForeName': 'Yi-Hua', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Administration, National Health Research Institutes, Zhunan, Miaoli County.'}, {'ForeName': 'Yuan-Ping', 'Initials': 'YP', 'LastName': 'Chang', 'Affiliation': 'Nursing Department, Fooyin University, 151 Jinxue Rd, Daliao District, Kaohsiung City 83102 Taiwan.'}, {'ForeName': 'De-Chih', 'Initials': 'DC', 'LastName': 'Lee', 'Affiliation': 'Department of Information Management, Da-Yeh University, Dacun, Changhua.'}]",Therapeutic advances in urology,['10.1177/1756287220940870']
2219,32782490,"Health-related quality of life in premenopausal women with hormone-receptor-positive, HER2-negative advanced breast cancer treated with ribociclib plus endocrine therapy: results from a phase III randomized clinical trial (MONALEESA-7).","Background


This analysis evaluated patient-reported outcomes (PROs) to assess health-related quality of life (HRQoL) in the phase III MONALEESA-7 trial, which previously demonstrated improvements in progression-free survival (PFS) and overall survival (OS) with ribociclib (cyclin-dependent kinase 4/6 inhibitor) + endocrine therapy (ET) compared with placebo + ET in pre- and perimenopausal patients with hormone-receptor-positive, HER2-negative (HR+/HER2-) advanced breast cancer (ABC).
Methods


The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire C30 (QLQ-C30) and the EQ-5D-5L were used to evaluate HRQoL.
Results


EORTC QLQ-C30 assessments were evaluable for 335 patients in the ribociclib arm and 337 patients in the placebo arm. Adherence rates at baseline and ⩾1 postbaseline time point were 90% and 83%, respectively. Patients treated with ribociclib + ET had a longer time to deterioration (TTD) ⩾ 10% in global HRQoL {hazard ratio (HR), 0.67 [95% confidence interval (CI), 0.52-0.86]}. TTD ⩾ 10% in global HRQoL was delayed in ribociclib-treated patients without  versus  with disease progression [HR, 0.31 (95% CI, 0.21-0.48)]. TTD ⩾ 10% in pain was longer with ribociclib + ET than with placebo + ET [HR, 0.65 (95% CI, 0.45-0.92)]. Patients who received a nonsteroidal aromatase inhibitor experienced similar benefits with ribociclib  versus  placebo in global HRQoL and pain.
Conclusion


HRQoL was maintained longer in patients who received ribociclib + ET  versus  placebo + ET. These data, combined with previously reported improvements in PFS and OS, support a strong clinical benefit-to-risk ratio with ribociclib-based treatment in pre- and perimenopausal patients with HR+/HER2- ABC.",2020,"Patients who received a nonsteroidal aromatase inhibitor experienced similar benefits with ribociclib  versus  placebo in global HRQoL and pain.
","['335 patients in the ribociclib arm and 337 patients in the', 'pre- and perimenopausal patients with hormone-receptor-positive, HER2-negative (HR+/HER2-) advanced breast cancer (ABC', 'premenopausal women with hormone-receptor-positive, HER2-negative advanced breast cancer treated with']","['placebo\u2009+\u2009ET', 'ribociclib\u2009+\u2009ET', 'ribociclib  versus  placebo', 'ribociclib plus endocrine therapy', 'nonsteroidal aromatase inhibitor', 'ribociclib (cyclin-dependent kinase 4/6 inhibitor)\u2009+\u2009endocrine therapy (ET', 'placebo']","['health-related quality of life (HRQoL', 'Adherence rates', 'progression-free survival (PFS) and overall survival (OS', 'longer time to deterioration (TTD', 'TTD\u2009⩾\u200910% in pain', 'Quality of Life questionnaire C30 (QLQ-C30', 'Health-related quality of life', 'Cancer (EORTC']","[{'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4045494', 'cui_str': 'ribociclib'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C4045494', 'cui_str': 'ribociclib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0243045', 'cui_str': 'cdk Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.451392,"Patients who received a nonsteroidal aromatase inhibitor experienced similar benefits with ribociclib  versus  placebo in global HRQoL and pain.
","[{'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'Breast Center, Department of Obstetrics and Gynecology and CCCLMU, Ludwig-Maximilians University Munich (LMU), Marchioninistrasse 15, München, 81377, Germany.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Franke', 'Affiliation': 'Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Villanueva-Vazquez', 'Affiliation': ""Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona, Spain.""}, {'ForeName': 'Yen-Shen', 'Initials': 'YS', 'LastName': 'Lu', 'Affiliation': 'National Taiwan University Hospital, Taipei.'}, {'ForeName': 'Debu', 'Initials': 'D', 'LastName': 'Tripathy', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Chow', 'Affiliation': 'Organisation for Oncology and Translational Research, Hong Kong.'}, {'ForeName': 'Govind K', 'Initials': 'GK', 'LastName': 'Babu', 'Affiliation': 'HCG Curie Centre of Oncology and Kidwai Memorial Institute of Oncology, Bangalore, Karnataka, India.'}, {'ForeName': 'Young-Hyuck', 'Initials': 'YH', 'LastName': 'Im', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chandiwana', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Gaur', 'Affiliation': 'Novartis Healthcare Pvt Ltd, Hyderabad, India.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Lanoue', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Rodriguez-Lorenc', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Bardia', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA.'}]",Therapeutic advances in medical oncology,['10.1177/1758835920943065']
2220,32782515,"Sodium valproate combined with levetiracetam in pediatric epilepsy and its influence on NSE, IL-6, hs-CRP and electroencephalogram improvement.","Efficacy of sodium valproate combined with levetiracetam (LEV) in pediatric epilepsy and its influence on neuron-specific enolase (NSE), interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hs-CRP) as well as electroencephalogram (EEG) improvement were studied. Patients (n=100) with pediatric epilepsy admitted to and treated in Xiantao First People's Hospital Affiliated to Yangtze University from December 2015 to 2018 were enrolled in this study and randomly divided into observation group (n=50) and control group (n=50). Sodium valproate was administered in the control group, and the treatment with LEV was combined with sodium valproate in the observation group. After 12 weeks the cognitive function of patients was assessed using the Mini-Mental State Examination (MMSE) scale, Montreal cognitive assessment (MoCA) scale and Wechsler Memory Scale-Revised in China (WMS-RC). The quality of life (QOL) of patients was evaluated with the QOL in epilepsy-31 inventory (QOLIE-31) scale and Barthel Index, and blood was drawn from the patients to detect the neurological function indicators [NSE and glial fibrillary acidic protein (GFAP)] and inflammatory indicators (IL-6, IL-2 and hs-CRP). After treatment, the incidence rates of adverse reactions notably declined in the observation group (P<0.05), and the improvement in the cognitive function in the observation group were both superior to those in the control group (P<0.05). Observation group had lowered content of NSE, GFAP, IL-6, hs-CRP and IL-2 (P<0.05), and α wave was markedly decreased, but θ and δ waves were notably increased in the observation group (P<0.05). In the treatment of pediatric epilepsy, sodium valproate combined with LEV produces better efficacy, fewer adverse reactions, significantly improves patients' QOL and notably lowers the content of NSE, IL-6 and hs-CRP with notable EEG improvement, so it is a safe and reliable treatment that is worth popularization.",2020,"Observation group had lowered content of NSE, GFAP, IL-6, hs-CRP and IL-2 (P<0.05), and α wave was markedly decreased, but θ and δ waves were notably increased in the observation group (P<0.05).","[""Patients (n=100) with pediatric epilepsy admitted to and treated in Xiantao First People's Hospital Affiliated to Yangtze University from December 2015 to 2018 were enrolled in this study and randomly divided into observation group (n=50) and control group (n=50""]","['sodium valproate combined with LEV', 'sodium valproate', 'Sodium valproate', 'Sodium valproate combined with levetiracetam', 'sodium valproate combined with levetiracetam (LEV']","['neurological function indicators [NSE and glial fibrillary acidic protein (GFAP)] and inflammatory indicators (IL-6, IL-2 and hs-CRP', 'NSE, IL-6, hs-CRP and electroencephalogram improvement', 'lowered content of NSE, GFAP, IL-6, hs-CRP and IL-2 (P<0.05), and α wave', 'cognitive function', 'θ and δ waves', 'Mini-Mental State Examination (MMSE) scale, Montreal cognitive assessment (MoCA) scale and Wechsler Memory Scale-Revised in China (WMS-RC', 'quality of life (QOL', 'neuron-specific enolase (NSE), interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hs-CRP', 'adverse reactions', 'incidence rates of adverse reactions', 'QOL in epilepsy-31 inventory (QOLIE-31) scale and Barthel Index, and blood']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0037567', 'cui_str': 'Valproate sodium'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}]","[{'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0017626', 'cui_str': 'Glial fibrillary acidic protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]",,0.0238594,"Observation group had lowered content of NSE, GFAP, IL-6, hs-CRP and IL-2 (P<0.05), and α wave was markedly decreased, but θ and δ waves were notably increased in the observation group (P<0.05).","[{'ForeName': 'Zhaoyang', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Pediatrics, Xiantao First People's Hospital Affiliated to Yangtze University, Xiantao, Hubei 433000, P.R. China.""}, {'ForeName': 'Jianmu', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Pediatrics, Xiantao First People's Hospital Affiliated to Yangtze University, Xiantao, Hubei 433000, P.R. China.""}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': ""Department of Pediatrics, Xiantao First People's Hospital Affiliated to Yangtze University, Xiantao, Hubei 433000, P.R. China.""}, {'ForeName': 'Yongbo', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""Department of Gastrointestinal Surgery, Xiantao First People's Hospital Affiliated to Yangtze University, Xiantao, Hubei 433000, P.R. China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Oncology, Xiantao First People's Hospital Affiliated to Yangtze University, Xiantao, Hubei 433000, P.R. China.""}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': ""Department of Ophthalmology, Xiantao First People's Hospital Affiliated to Yangtze University, Xiantao, Hubei 433000, P.R. China.""}, {'ForeName': 'Wenbing', 'Initials': 'W', 'LastName': 'Su', 'Affiliation': ""Department of Gastrointestinal Medicine, Xiantao First People's Hospital Affiliated to Yangtze University, Xiantao, Hubei 433000, P.R. China.""}]",Experimental and therapeutic medicine,['10.3892/etm.2020.8916']
2221,32782568,Enhanced therapeutic effect of transcatheter arterial chemoembolization combined with radioactive I-125 seed implantation on liver cancer.,"The present study aimed to evaluate the therapeutic effect of transcatheter arterial chemoembolization (TACE) combined with radioactive I-125 (iodine-125) seed implantation on liver cancer. A total of 38 liver cancer patients in the combined treatment group were treated with lobaplatin-TACE combined with radioactive I-125 seed implantation, while 45 patients in the TACE group were treated only with lobaplatin-TACE. Patients were followed up for survival time, and the liver function, change in α-fetoprotein (AFP) and side effects were evaluated. The average survival time of patients was 6.1 months in the TACE group and 8.2 months in the combined treatment group, and the overall survival was significantly different between the two groups (P<0.05). The response rate of lesions in the combined treatment group was superior to that observed in the TACE group, and the change in AFP in the TACE group was smaller than that in the combined treatment group. Improvement in the effects on most liver function indices in the combined treatment group were better than those in the TACE group. In addition, there were no differences in the side effects experienced between the two groups. Results of this study indicate that the effect of TACE combined with radioactive I-125 seed implantation is superior to that of TACE alone for the treatment of liver cancer, which can further benefit patients.",2020,Improvement in the effects on most liver function indices in the combined treatment group were better than those in the TACE group.,"['38 liver cancer patients', 'liver cancer']","['TACE', 'transcatheter arterial chemoembolization combined with radioactive I-125 seed implantation', 'transcatheter arterial chemoembolization (TACE) combined with radioactive I-125 (iodine-125) seed implantation', 'lobaplatin-TACE combined with radioactive I-125 seed implantation', 'lobaplatin-TACE']","['survival time, and the liver function, change in α-fetoprotein (AFP) and side effects', 'response rate of lesions', 'overall survival', 'liver function indices', 'average survival time', 'change in AFP', 'liver cancer', 'side effects']","[{'cui': 'C0345904', 'cui_str': 'Malignant neoplasm of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2711393', 'cui_str': 'Transarterial chemoembolization of hepatic artery'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0034553', 'cui_str': 'Radioactivity'}, {'cui': 'C0796396', 'cui_str': 'Iodine-125'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0165747', 'cui_str': 'lobaplatin'}]","[{'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015950', 'cui_str': 'Fetoprotein'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0201539', 'cui_str': 'Alpha-1-Fetoprotein measurement'}, {'cui': 'C0345904', 'cui_str': 'Malignant neoplasm of liver'}]",38.0,0.0249952,Improvement in the effects on most liver function indices in the combined treatment group were better than those in the TACE group.,"[{'ForeName': 'Wenbao', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Intervention Therapy, Laiyang Central Hospital, Yantai, Shandong 265200, P.R. China.'}, {'ForeName': 'Nanguang', 'Initials': 'N', 'LastName': 'Xiu', 'Affiliation': 'Department of Intervention Therapy, Laiyang Central Hospital, Yantai, Shandong 265200, P.R. China.'}, {'ForeName': 'Jinwei', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Intervention Therapy, Laiyang Central Hospital, Yantai, Shandong 265200, P.R. China.'}, {'ForeName': 'Lianhao', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Intervention Therapy, Laiyang Central Hospital, Yantai, Shandong 265200, P.R. China.'}]",Oncology letters,['10.3892/ol.2020.11765']
2222,32782626,"Effectiveness of a resistance training program on physical function, muscle strength, and body composition in community-dwelling older adults receiving home care: a cluster-randomized controlled trial.","Background


Aging is associated with reduced muscle mass and strength leading to impaired physical function. Resistance training programs incorporated into older adults' real-life settings may have the potential to counteract these changes. We evaluated the effectiveness of 8 months resistance training using easily available, low cost equipment compared to physical activity counselling on physical function, muscle strength, and body composition in community-dwelling older adults receiving home care.
Methods


This open label, two-armed, parallel group, cluster randomized trial recruited older adults above 70 years (median age 86.0 (Interquartile range 80-90) years) receiving home care. Participants were randomized at cluster level to the resistance training group (RTG) or the control group (CG). The RTG trained twice a week while the CG were informed about the national recommendations for physical activity and received a motivational talk every 6th week. Outcomes were assessed at participant level at baseline, after four, and 8 months and included tests of physical function (chair rise, 8 ft-up-and-go, preferred- and maximal gait speed, and stair climb), maximal strength, rate of force development, and body composition.
Results


Twelve clusters were allocated to RTG (7 clusters, 60 participants) or CG (5 clusters, 44 participants). The number of participants analyzed was 56-64 (6-7 clusters) in RTG and 20-42 (5 clusters) in CG. After 8 months, multilevel linear mixed models showed that RTG improved in all tests of physical function and maximal leg strength (9-24%,  p  = 0.01-0.03) compared to CG. No effects were seen for rate of force development or body composition.
Conclusion


This study show that resistance training using easily available, low cost equipment is more effective than physical activity counselling for improving physical function and maximal strength in community-dwelling older adults receiving home care.
Trial registration


ISRCTN1067873.",2020,"After 8 months, multilevel linear mixed models showed that RTG improved in all tests of physical function and maximal leg strength (9-24%,  p  = 0.01-0.03) compared to CG.","['community-dwelling older adults receiving home care', 'older adults above 70\u2009years (median age 86.0 (Interquartile range 80-90) years) receiving home care']","['resistance training program', 'Resistance training programs', 'RTG', 'CG', 'physical activity counselling', 'resistance training group (RTG) or the control group (CG']","['rate of force development or body composition', 'physical function, muscle strength, and body composition', 'physical function and maximal leg strength', 'physical function (chair rise, 8\u2009ft-up-and-go, preferred- and maximal gait speed, and stair climb), maximal strength, rate of force development, and body composition']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}]",12.0,0.0389963,"After 8 months, multilevel linear mixed models showed that RTG improved in all tests of physical function and maximal leg strength (9-24%,  p  = 0.01-0.03) compared to CG.","[{'ForeName': 'Hilde Bremseth', 'Initials': 'HB', 'LastName': 'Bårdstu', 'Affiliation': 'Department of Sport, Food and Natural Sciences, Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, PB 133, 6851 Sogndal, Norway.'}, {'ForeName': 'Vidar', 'Initials': 'V', 'LastName': 'Andersen', 'Affiliation': 'Department of Sport, Food and Natural Sciences, Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, PB 133, 6851 Sogndal, Norway.'}, {'ForeName': 'Marius Steiro', 'Initials': 'MS', 'LastName': 'Fimland', 'Affiliation': 'Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Aasdahl', 'Affiliation': 'Unicare Helsefort Rehabilitation Centre, Rissa, Norway.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Raastad', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Kristoffer T', 'Initials': 'KT', 'LastName': 'Cumming', 'Affiliation': 'Department of Sports, Physical Education and Outdoor Studies, Faculty of Humanities, Sports and Educational Science, University of South-Eastern Norway, Vestfold, Norway.'}, {'ForeName': 'Atle Hole', 'Initials': 'AH', 'LastName': 'Sæterbakken', 'Affiliation': 'Department of Sport, Food and Natural Sciences, Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, PB 133, 6851 Sogndal, Norway.'}]",European review of aging and physical activity : official journal of the European Group for Research into Elderly and Physical Activity,['10.1186/s11556-020-00243-9']
2223,32782630,A prospective multicenter study of direct comparison of feasibility and safety of pulmonary vein isolation using the minimally interrupted apixaban between second-generation cryoballoon and radiofrequency ablation of paroxysmal atrial fibrillation: J-HIT apixaban.,"Background


The feasibility and safety of pulmonary vein isolation (PVI) using cryoballoon (CB) for paroxysmal atrial fibrillation (PAF) with minimally interrupted apixaban has not fully explored.
Methods


In this multicenter, randomized prospective study, we enrolled patients with PAF undergoing CB or radiofrequency (RF) ablation with interrupted (holding 1 dose) apixaban. The primary composite end point consisted of bleeding events, including pericardial effusion and major bleeding requiring blood transfusion, or thromboembolic events at 4 weeks after ablation; secondary end points included early recurrence of AF and procedural duration.
Results


A total of 250 patients underwent PVI (125 assigned to the RF ablation and 125 assigned to the CB ablation). The primary end point occurred in 1 patient in the CB ablation group (0.8%; 90% confidence interval [CI], 0.04 to 3.70) and 3 patients in the RF group (2.4%,  P  = .622; risk ratio, 0333; 90% CI, 0.05 to 2.20). All events were pericardial effusion, all of whom recovered after pericardiocentesis. Early recurrence of AF occurred in 4 patients (3.2%) in the RF group and in 6 patients (4.8%) in the CB group ( P  = .749). The procedural duration was shorter in the CB group than that in the RF group (136.5 ± 39.9 vs 179.5 ± 44.8 min,  P  < .001).
Conclusion


CB ablation with minimally interrupted apixaban was feasible and safe in patients with PAF undergoing PVI, which was equivalent to RF ablation.",2020,"The primary end point occurred in 1 patient in the CB ablation group (0.8%; 90% confidence interval [CI], 0.04 to 3.70) and 3 patients in the RF group (2.4%,  P  = .622; risk ratio, 0333; 90% CI, 0.05 to 2.20).","['paroxysmal atrial fibrillation (PAF', 'paroxysmal atrial fibrillation', '250 patients underwent PVI (125 assigned to the', 'enrolled patients with PAF undergoing CB or', 'patients with PAF undergoing PVI']","['CB ablation with minimally interrupted apixaban', 'radiofrequency (RF) ablation with interrupted (holding 1 dose) apixaban', 'pulmonary vein isolation (PVI) using cryoballoon (CB', 'pulmonary vein isolation using the minimally interrupted apixaban between second-generation cryoballoon and radiofrequency ablation', 'RF ablation']","['bleeding events, including pericardial effusion and major bleeding requiring blood transfusion, or thromboembolic events', 'early recurrence of AF and procedural duration', 'procedural duration', 'Early recurrence of AF']","[{'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031039', 'cui_str': 'Pericardial effusion'}, {'cui': 'C3160769', 'cui_str': 'Major bleed'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",250.0,0.0592326,"The primary end point occurred in 1 patient in the CB ablation group (0.8%; 90% confidence interval [CI], 0.04 to 3.70) and 3 patients in the RF group (2.4%,  P  = .622; risk ratio, 0333; 90% CI, 0.05 to 2.20).","[{'ForeName': 'Atsuhiko', 'Initials': 'A', 'LastName': 'Yagishita', 'Affiliation': 'Department of Cardiovascular Medicine/Heart Rhythm Center Tokyo Medical and Dental University Tokyo Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Goya', 'Affiliation': 'Department of Cardiovascular Medicine/Heart Rhythm Center Tokyo Medical and Dental University Tokyo Japan.'}, {'ForeName': 'Yoshito', 'Initials': 'Y', 'LastName': 'Iesaka', 'Affiliation': 'Cardiovascular Center Tsuchiura Kyodo Hospital Tsuchiura Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Nitta', 'Affiliation': 'Department of Cardiology Saitama Red Cross Hospital Saitama Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Takahashi', 'Affiliation': 'Cardiovascular Center Yokosuka Kyosai Hospital Yokosuka Japan.'}, {'ForeName': 'Yasutoshi', 'Initials': 'Y', 'LastName': 'Nagata', 'Affiliation': 'Division of Cardiology Musashino Red Cross Hospital Tokyo Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Hachiya', 'Affiliation': 'Cardiovascular Center Tsuchiura Kyodo Hospital Tsuchiura Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Inaba', 'Affiliation': 'Department of Cardiology Saitama Red Cross Hospital Saitama Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Inamura', 'Affiliation': 'Department of Cardiology Saitama Red Cross Hospital Saitama Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Cardiovascular Center Yokosuka Kyosai Hospital Yokosuka Japan.'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Division of Cardiology Musashino Red Cross Hospital Tokyo Japan.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Tao', 'Affiliation': 'Department of Cardiovascular Medicine/Heart Rhythm Center Tokyo Medical and Dental University Tokyo Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Shirai', 'Affiliation': 'Department of Cardiovascular Medicine/Heart Rhythm Center Tokyo Medical and Dental University Tokyo Japan.'}, {'ForeName': 'Tasuku', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Cardiovascular Medicine/Heart Rhythm Center Tokyo Medical and Dental University Tokyo Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Shiohira', 'Affiliation': 'Department of Cardiovascular Medicine/Heart Rhythm Center Tokyo Medical and Dental University Tokyo Japan.'}, {'ForeName': 'Kikou', 'Initials': 'K', 'LastName': 'Akiyoshi', 'Affiliation': 'Department of Cardiovascular Medicine/Heart Rhythm Center Tokyo Medical and Dental University Tokyo Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Sekigawa', 'Affiliation': 'Department of Cardiovascular Medicine/Heart Rhythm Center Tokyo Medical and Dental University Tokyo Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Maeda', 'Affiliation': 'Department of Advanced Arrhythmia Research Tokyo Medical and Dental University Tokyo Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sasaki', 'Affiliation': 'Department of Cardiovascular Medicine/Heart Rhythm Center Tokyo Medical and Dental University Tokyo Japan.'}, {'ForeName': 'Yoshihide', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Advanced Arrhythmia Research Tokyo Medical and Dental University Tokyo Japan.'}, {'ForeName': 'Mihoko', 'Initials': 'M', 'LastName': 'Kawabata', 'Affiliation': 'Department of Cardiovascular Medicine/Heart Rhythm Center Tokyo Medical and Dental University Tokyo Japan.'}, {'ForeName': 'Kenzo', 'Initials': 'K', 'LastName': 'Hirao', 'Affiliation': 'Department of Cardiovascular Medicine/Heart Rhythm Center Tokyo Medical and Dental University Tokyo Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of arrhythmia,['10.1002/joa3.12392']
2224,32788268,Early Feeding in Acute Pancreatitis in Children: A Randomized Controlled Trial.,"BACKGROUND


Studies have increasingly challenged the traditional management of acute pancreatitis (AP) with bowel rest. However, these studies used a low-fat diet or transgastric feeding and only included adults. Aiming to generate higher-quality prospective pediatric data, we compared the traditional approach of fasting and intravenous fluids and early enteral feeding with standard diet or formula.
METHODS


Randomized controlled trial of children (2-18 years) with mild-moderate AP. Patients were randomly assigned 1:1 to initial fasting and intravenous fluids or an immediate, unrestricted diet. Pain scores, blood measures, and cross-sectional imaging were recorded throughout admission and follow-up. The primary outcome was time to discharge, and secondary outcomes were clinical and biochemical resolution and local and systemic complication rates.
RESULTS


Of 33 patients (17 [52%] boys, mean age of 11.5 [±4.8] years), 18 (55%) were randomly assigned to early feeding and 15 (45%) were randomly assigned to initial fasting. We recorded the median (interquartile range [IQR]) time to discharge (2.6 [IQR 2.0 to 4.0] vs 2.9 [IQR 1.8 to 5.6];  P  = .95), reduction in serum lipase levels by day 2 (58% [IQR 2% to 85%] vs 48% [IQR 3% to 71%];  P  = .65), and readmission rates (1 of 18 [6%] vs 2 of 15 [13%];  P  = .22) between the early feeding and fasting cohorts, respectively. Immediate or delayed complication rates did not differ. Patients randomly assigned to early feeding had weight gain of 1.3 kg (IQR 0.29 to 3.6) at follow-up, compared with weight loss of 0.8 kg (IQR -2.1 to 0.7) in fasted patients ( P  = .028).
CONCLUSIONS


This is the first randomized controlled trial in pediatric AP. There was no difference between early commencement of a standard oral diet and initial fast in any of the major outcome measures.",2020,There was no difference between early commencement of a standard oral diet and initial fast in any of the major outcome measures.,"['Acute Pancreatitis in Children', '33 patients (17 [52%] boys, mean age of 11.5 [±4.8] years), 18 (55%) were randomly assigned to early feeding and 15 (45', 'children (2-18 years) with mild-moderate AP']","['fasting and intravenous fluids and early enteral feeding with standard diet or formula', 'initial fasting and intravenous fluids or an immediate, unrestricted diet']","['time to discharge, and secondary outcomes were clinical and biochemical resolution and local and systemic complication rates', 'median (interquartile range [IQR]) time to discharge', 'weight gain', 'Immediate or delayed complication rates', 'weight loss', 'readmission rates', 'Pain scores, blood measures, and cross-sectional imaging', 'serum lipase levels']","[{'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0428316', 'cui_str': 'Serum lipase measurement'}]",,0.140362,There was no difference between early commencement of a standard oral diet and initial fast in any of the major outcome measures.,"[{'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Ledder', 'Affiliation': 'Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel; orenl@szmc.org.il.'}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Duvoisin', 'Affiliation': ""Department of Paediatric Gastroenterology, Sydney Children's Hospital, Sydney, Australia.""}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Lekar', 'Affiliation': 'Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Robert N', 'Initials': 'RN', 'LastName': 'Lopez', 'Affiliation': ""Department of Paediatric Gastroenterology, Sydney Children's Hospital, Sydney, Australia.""}, {'ForeName': 'Harveen', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': ""Department of Paediatric Gastroenterology, Sydney Children's Hospital, Sydney, Australia.""}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Dehlsen', 'Affiliation': ""Department of Paediatric Gastroenterology, Sydney Children's Hospital, Sydney, Australia.""}, {'ForeName': 'Raffi', 'Initials': 'R', 'LastName': 'Lev-Tzion', 'Affiliation': 'Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Orlanski-Meyer', 'Affiliation': 'Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Shteyer', 'Affiliation': 'Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Krishnan', 'Affiliation': ""Department of Paediatric Gastroenterology, Sydney Children's Hospital, Sydney, Australia.""}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': ""Department of Paediatric Gastroenterology, Sydney Children's Hospital, Sydney, Australia.""}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Lemberg', 'Affiliation': ""Department of Paediatric Gastroenterology, Sydney Children's Hospital, Sydney, Australia.""}, {'ForeName': 'Shlomi', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': ""Department of Paediatric Gastroenterology, Dana-Dwek Children's Hospital, Tel Aviv, Israel; and.""}, {'ForeName': 'Chee Y', 'Initials': 'CY', 'LastName': 'Ooi', 'Affiliation': ""Department of Paediatric Gastroenterology, Sydney Children's Hospital, Sydney, Australia.""}]",Pediatrics,['10.1542/peds.2020-1149']
2225,32788274,Symptom reduction in palliative care from single session mindful breathing: a randomised controlled trial.,"CONTEXT


There has been increasing evidence of the role of mindfulness-based interventions in improving various health conditions. However, the evidence for the use of mindfulness in the palliative care setting is still lacking.
OBJECTIVES


The objective of our study was to determine the efficacy of a single session of 20 min mindful breathing in alleviating multiple symptoms in palliative care.
METHODS


Adult palliative care in patients with at least one symptom scoring ≥5/10 based on the Edmonton Symptom Assessment Scale (ESAS) were recruited from September 2018 to December 2018. Recruited patients were randomly assigned to either 20 min mindful breathing and standard care or standard care alone.
RESULTS


Forty patients were randomly assigned to standard care plus a 20 min mindful breathing session (n=20) or standard care alone (n=20). There was statistically significant reduction of total ESAS score in the mindful breathing group compared with the control group at minute 20 (U=98, n  1  = n  2  = 20, mean rank  1  = 15.4, mean rank  2  = 25.6, median reduction  1  = 6.5, median reduction  2  = 1.5, z=-2.763, r=0.3, p=0.005).
CONCLUSION


Our results provided evidence that a single session of 20 min mindful breathing was effective in reducing multiple symptoms rapidly for palliative care patients.",2020,"There was statistically significant reduction of total ESAS score in the mindful breathing group compared with the control group at minute 20 (U=98, n  1  = n  2  = 20,","['Adult palliative care in patients with at least one symptom scoring ≥5/10 based on the Edmonton Symptom Assessment Scale (ESAS) were recruited from September 2018 to December 2018', 'palliative care patients', 'Forty patients']","['palliative care from single session mindful breathing', '20\u2009min mindful breathing', 'standard care plus a 20\u2009min mindful breathing session', 'standard care alone', '20\u2009min mindful breathing and standard care or standard care alone']",['total ESAS score'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0423455,"There was statistically significant reduction of total ESAS score in the mindful breathing group compared with the control group at minute 20 (U=98, n  1  = n  2  = 20,","[{'ForeName': 'Mei Ling', 'Initials': 'ML', 'LastName': 'Look', 'Affiliation': 'Medicine, University of Malaya Medical Centre, Kuala Lumpur, Wilayah Persekutuan, Malaysia entitylml@yahoo.com.'}, {'ForeName': 'Seng Beng', 'Initials': 'SB', 'LastName': 'Tan', 'Affiliation': 'Medicine, University of Malaya Medical Centre, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Li Li', 'Initials': 'LL', 'LastName': 'Hong', 'Affiliation': 'Medicine, University of Malaya Medical Centre, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Chong Guan', 'Initials': 'CG', 'LastName': 'Ng', 'Affiliation': 'Psychological Medicine, University Malaya Medical Center, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Hway Ann', 'Initials': 'HA', 'LastName': 'Yee', 'Affiliation': 'Psychological Medicine, University Malaya Medical Center, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Liang Yik', 'Initials': 'LY', 'LastName': 'Lim', 'Affiliation': 'Medicine, University of Malaya Medical Centre, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Diana Leh Ching', 'Initials': 'DLC', 'LastName': 'Ng', 'Affiliation': 'Medicine, University of Malaya Medical Centre, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Chee Shee', 'Initials': 'CS', 'LastName': 'Chai', 'Affiliation': 'Medicine, University of Malaya Medical Centre, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Ee Chin', 'Initials': 'EC', 'LastName': 'Loh', 'Affiliation': 'Medicine, University of Malaya Medical Centre, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Chee Loong', 'Initials': 'CL', 'LastName': 'Lam', 'Affiliation': 'Medicine, University of Malaya Medical Centre, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}]",BMJ supportive & palliative care,['10.1136/bmjspcare-2020-002382']
2226,32788281,Effect of 6 Months of Flash Glucose Monitoring in Youth With Type 1 Diabetes and High-Risk Control: A Randomized Controlled Trial.,"OBJECTIVE


To investigate whether intermittently scanned continuous glucose monitoring (isCGM) significantly improves glycemic control compared with capillary self-monitored blood glucose (SMBG) in youth with type 1 diabetes and high-risk glycemic control.
RESEARCH DESIGN AND METHODS


This multicenter 6-month randomized, controlled, parallel-arm trial included 64 participants aged 13-20 years with established type 1 diabetes and glycated hemoglobin (HbA 1c ) ≥9% (≥75 mmol/mol). Participants were allocated to 6-month intervention (isCGM; FreeStyle Libre; Abbott Diabetes Care, Witney, U.K.) ( n  = 33) or control (SMBG;  n  = 31) using minimization. The primary outcome was the difference in change in HbA 1c  from baseline to 6 months.
RESULTS


There was no evidence of a difference between groups for changes in HbA 1c  at 6 months (adjusted mean 0.2% greater improvement for isCGM [95% CI -0.9 to 0.5] [-2.1 mmol/mol (95% CI -9.6 to 5.4)];  P  = 0.576). However, glucose-monitoring frequency was 2.83 (95% CI 1.72-4.65;  P  < 0.001) times higher in the isCGM group compared with that in the SMBG group at 6 months. The change in the Diabetes Treatment Satisfaction Questionnaire mean item score also favored isCGM at 6 months ( P  = 0.048), with no significant differences between groups for fear of hypoglycemia and quality of life (both general and diabetes specific) (all  P  > 0.1).
CONCLUSIONS


For youth with high-risk glycemic control, isCGM led to improvements in glucose testing frequency and diabetes treatment satisfaction. However, these did not translate to greater improvement in glycemic control over usual care with SMBG at 6 months.",2020,"The change in the Diabetes Treatment Satisfaction Questionnaire mean item score also favored isCGM at 6 months ( P  = 0.048), with no significant differences between groups for fear of hypoglycemia and quality of life (both general and diabetes specific) (all  P  > 0.1).
","['Youth With Type 1 Diabetes and High-Risk Control', 'youth with high-risk glycemic control', 'youth with type 1 diabetes and high-risk glycemic control', '64 participants aged 13-20 years with established type 1 diabetes and glycated hemoglobin (HbA 1c ) ≥9% (≥75 mmol/mol']","['intermittently scanned continuous glucose monitoring (isCGM', '6-month intervention (isCGM; FreeStyle Libre; Abbott Diabetes Care, Witney, U.K.) ( n  = 33) or control (SMBG;  n  = 31) using minimization', 'isCGM', 'SMBG', 'Flash Glucose Monitoring', 'capillary self-monitored blood glucose (SMBG']","['change in HbA 1c', 'Diabetes Treatment Satisfaction Questionnaire mean item score', 'glucose testing frequency and diabetes treatment satisfaction', 'glucose-monitoring frequency', 'glycemic control', 'fear of hypoglycemia and quality of life (both general and diabetes specific']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}]","[{'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0006901', 'cui_str': 'Structure of capillary blood vessel (organ)'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0451116', 'cui_str': 'Diabetes treatment satisfaction questionnaire'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0595310', 'cui_str': 'Blood glucose testing kit'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",64.0,0.0891015,"The change in the Diabetes Treatment Satisfaction Questionnaire mean item score also favored isCGM at 6 months ( P  = 0.048), with no significant differences between groups for fear of hypoglycemia and quality of life (both general and diabetes specific) (all  P  > 0.1).
","[{'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Boucher', 'Affiliation': ""Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Gray', 'Affiliation': 'Centre for Biostatistics, Division of Health Sciences, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Esko J', 'Initials': 'EJ', 'LastName': 'Wiltshire', 'Affiliation': 'Department of Paediatrics and Child Health, University of Otago, Wellington, Wellington, New Zealand.'}, {'ForeName': 'Martin I', 'Initials': 'MI', 'LastName': 'de Bock', 'Affiliation': 'Paediatric Department, Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'Galland', 'Affiliation': ""Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Tomlinson', 'Affiliation': ""Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Jenny A', 'Initials': 'JA', 'LastName': 'Rayns', 'Affiliation': 'Endocrinology Department, Southern District Health Board, Dunedin, New Zealand.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'MacKenzie', 'Affiliation': 'Paediatric Department, Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Chan', 'Affiliation': 'Department of Endocrinology and General Medicine, Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Rose', 'Affiliation': ""Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Wheeler', 'Affiliation': ""Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand ben.wheeler@otago.ac.nz.""}]",Diabetes care,['10.2337/dc20-0613']
2227,32788318,Comparison of the Effectiveness and Comfort Level of Two Commonly Used Mask Ventilation Techniques in a Simulated Model.,"BACKGROUND


Mask ventilation is an important rescue airway skill for providing oxygenation and ventilation. Maintaining a good face mask seal is a fundamental factor for successful ventilation. Therefore, the aim of this study was to compare the effectiveness and comfortability of 2 commonly used mask ventilation techniques.
METHODS


A randomized crossover study was performed to compare the 2-handed C-E and 2-handed V-E techniques on a simulation model. Respiratory therapists were recruited by convenience sampling to hold the mask during mechanical ventilation with a fixed tidal volume (V T ) of 50 mL, a rate of 12 breaths/min and a PEEP of zero were provided. Each participant performed a 2-min ventilation session, with a total of 24 breaths for each technique. For each technique, we recorded the median V T  and the number of successful breaths (≥300 mL). Provider comfort was assessed by using a 5-point Likert scale at the end of the 2 techniques. Subgroup analyses were conducted for sex, experience, and height of the participants.
RESULTS


Of the 75 respiratory therapists recruited, 74 participants were included in the analysis. There was no statistically significant difference in the median V T  between the V-E (417 mL [interquartile range, 396-427] mL) and C-E techniques (410 [interquartile range, 391-423] mL)  (P  = .82). Approximately 74% of breaths delivered by the C-E technique were effective, whereas only 68% of those delivered by the V-E technique were effective  (P  < .001). Most of the participants reported that using the 2-handed C-E technique was more comfortable.
CONCLUSIONS


In our study, the median V T  did not differ significantly between the 2 techniques. However, the C-E technique seemed to be superior to the V-E technique in terms of the number of effectively delivered breaths and comfortability. Further studies are recommended for basic airway management techniques.",2020,"There was no statistically significant difference in the median V T  between the V-E (417 mL [interquartile range, 396-427] mL) and C-E techniques (410 [interquartile range, 391-423] mL)  (P  = .82).","['74 participants were included in the analysis', '75 respiratory therapists recruited']","['Mask ventilation', '2-handed C-E and 2-handed V-E techniques', 'Two Commonly Used Mask Ventilation Techniques']","['median V T  and the number of successful breaths', 'median V T', 'Provider comfort']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1709924', 'cui_str': 'Respiratory therapist'}]","[{'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0231963', 'cui_str': 'Volume of expired gas'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0225386', 'cui_str': 'Breath'}]",74.0,0.0578828,"There was no statistically significant difference in the median V T  between the V-E (417 mL [interquartile range, 396-427] mL) and C-E techniques (410 [interquartile range, 391-423] mL)  (P  = .82).","[{'ForeName': 'Saqer M', 'Initials': 'SM', 'LastName': 'Althunayyan', 'Affiliation': 'Department of Accident and Trauma, Prince Sultan Bin Abdulaziz College for Emergency Medical Services, King Saud University, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Raied N', 'Initials': 'RN', 'LastName': 'Alotaibi', 'Affiliation': 'Department of Basic Science, Prince Sultan Bin Abdulaziz College for Emergency Medical Services, King Saud University, Riyadh, Kingdom of Saudi Arabia. ralotaibi1@KSU.EDU.SA.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Aljanoubi', 'Affiliation': 'Department of Aviation and Marines, Prince Sultan Bin Abdulaziz College for Emergency Medical Services, King Saud University, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Musab Z', 'Initials': 'MZ', 'LastName': 'Alharthi', 'Affiliation': 'Department of Accident and Trauma, Prince Sultan Bin Abdulaziz College for Emergency Medical Services, King Saud University, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Abdullah M', 'Initials': 'AM', 'LastName': 'Mubarak', 'Affiliation': 'Department of Basic Science, Prince Sultan Bin Abdulaziz College for Emergency Medical Services, King Saud University, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Al-Otaibi', 'Affiliation': 'Department of Emergency Medical Services, Prince Sultan Bin Abdulaziz College for Emergency Medical Services, King Saud University, Riyadh, Kingdom of Saudi Arabia.'}]",Respiratory care,['10.4187/respcare.07949']
2228,32788396,Infections in baricitinib clinical trials for patients with active rheumatoid arthritis.,"OBJECTIVES


To evaluate the incidence of infection in patients with active rheumatoid arthritis (RA) treated with baricitinib, an oral selective Janus kinase (JAK)1 and JAK2 inhibitor.
METHODS


Infections are summarised from an integrated database (8 phase 3/2/1b clinical trials and 1 long-term extension (LTE)) with data to 1 April 2017. The 'all-bari-RA' analysis set included patients who received any baricitinib dose. Placebo comparison was based on six studies with 4 mg and placebo to week 24, including four trials with 2 mg (placebo-controlled set). Dose-response assessment was based on four studies with 2 mg and 4 mg, including LTE data (2-4 mg extended set).
RESULTS


There were 3492 patients who received baricitinib for 7860 patient-years (PY) of exposure (median 2.6 years, maximum 6.1 years). Treatment-emergent infections were higher for baricitinib versus placebo (exposure-adjusted incidence rate (IR)/100 PY: placebo 75.9, 2 mg 84.0 (p not significant), 4 mg 88.4 (p≤0.001)). The IR of serious infection was similar for baricitinib versus placebo and stable over time (all-bari-RA IR 3.0/100 PY). There were 11 cases of tuberculosis (all-bari-RA IR 0.1/100 PY); all occurred with 4 mg in endemic regions. Herpes zoster (HZ) IR/100 PY was higher for baricitinib versus placebo (placebo 1.0, 2 mg 3.1 (p not significant), 4 mg 4.3 (p≤0.01)); rates remained elevated and stable over time (all-bari-RA 3.3). Opportunistic infections, including multidermatomal HZ, were infrequent in the baricitinib programme (all-bari-RA IR 0.5/100 PY).
CONCLUSIONS


Increased rates of treatment-emergent infections including HZ were observed in patients with RA treated with baricitinib, consistent with baricitinib's immunomodulatory mode of action.",2020,"PY was higher for baricitinib versus placebo (placebo 1.0, 2 mg 3.1 (p not significant), 4 mg 4.3 (p≤0.01)); rates remained elevated and stable over time (all-bari-RA 3.3).","['3492 patients who received baricitinib for 7860 patient-years (PY) of exposure (median 2.6 years, maximum 6.1 years', 'patients with active rheumatoid arthritis', 'Infections are summarised from an integrated database (8 phase 3/2/1b clinical trials and 1 long-term extension (LTE)) with data to 1 April 2017', 'patients with active rheumatoid arthritis (RA) treated with']","['placebo', 'placebo (placebo', 'Placebo', 'baricitinib, an oral selective Janus kinase (JAK)1 and JAK2 inhibitor']",['IR of serious infection'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0597721', 'cui_str': 'JAK Kinases'}, {'cui': 'C0266700', 'cui_str': 'Janiceps'}, {'cui': 'C0169661', 'cui_str': 'JAK2 Protein Tyrosine Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",,0.135206,"PY was higher for baricitinib versus placebo (placebo 1.0, 2 mg 3.1 (p not significant), 4 mg 4.3 (p≤0.01)); rates remained elevated and stable over time (all-bari-RA 3.3).","[{'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Winthrop', 'Affiliation': 'Division of Infectious Diseases, Oregon Health and Science University, Portland, Oregon, USA winthrop@ohsu.edu.'}, {'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Harigai', 'Affiliation': ""Department of Rheumatology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.""}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Genovese', 'Affiliation': 'Division of Immunology and Rheumatology, Stanford University, Palo Alto, California, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lindsey', 'Affiliation': 'Ochsner Health Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Fleischmann', 'Affiliation': 'Metroplex Clinical Research Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Bradley', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Byers', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Hyslop', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Maher', 'Initials': 'M', 'LastName': 'Issa', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nishikawa', 'Affiliation': 'Lilly Japan KK, Kobe, Japan.'}, {'ForeName': 'Terence P', 'Initials': 'TP', 'LastName': 'Rooney', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Witt', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Christina L', 'Initials': 'CL', 'LastName': 'Dickson', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Josef S', 'Initials': 'JS', 'LastName': 'Smolen', 'Affiliation': 'Division of Rheumatology, Department of Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Cochin Hospital, APHP and INSERM U-1153, CRESS Paris-Sorbonne, Paris, France.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216852']
2229,32788412,Efficacy of an 8-Week Resistance Training Program in Older Adults: A Randomized Controlled Trial.,"Older adults are challenged with aging-related declines in skeletal muscle mass and function. Although exercise interventions of longer duration typically yield larger changes, shorter-term interventions may kick-start positive effects, allowing participants to begin engaging in more activity. This study aimed to determine whether 8 weeks of a resistance training program (Stay Strong, Stay Healthy [SSSH]) improved dynamic muscle strength, balance, flexibility, and sleep. Inactive adults aged ≥60 years were randomized into SSSH (n = 15), walking (WALK; n = 17), or control (CON; n = 14) groups. The SSSH and WALK groups met 2 times per week for 60 min. The participants completed pre/post general health, activity, and sleep questionnaires; DXA scans; and functional tasks. One-way repeated-measures multivariate analysis of variance was used to determine interactions and decomposed using repeated-measures analysis of variance. SSSH improved sit-to-stand performance, back scratch distance, and sleep quality and reported more auxiliary physical activity than WALK or CON (p < .05). Resistance training interventions in sedentary older adults can improve physical function and encourage additional activity in 8 weeks.",2020,"SSSH improved sit-to-stand performance, back scratch distance, and sleep quality and reported more auxiliary physical activity than WALK or CON (p < .05).","['sedentary older adults', 'Inactive adults aged ≥60\xa0years', 'Older Adults', 'Older adults']","['8-Week Resistance Training Program', 'resistance training program (Stay Strong, Stay Healthy [SSSH', 'SSSH', 'Resistance training interventions']","['dynamic muscle strength, balance, flexibility, and sleep', 'auxiliary physical activity', 'general health, activity, and sleep questionnaires; DXA scans; and functional tasks', 'SSSH improved sit-to-stand performance, back scratch distance, and sleep quality']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0311213', 'cui_str': 'Dermatitis verrucosa'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",,0.0468909,"SSSH improved sit-to-stand performance, back scratch distance, and sleep quality and reported more auxiliary physical activity than WALK or CON (p < .05).","[{'ForeName': 'Breanne S', 'Initials': 'BS', 'LastName': 'Baker', 'Affiliation': ''}, {'ForeName': 'Kelsey J', 'Initials': 'KJ', 'LastName': 'Weitzel', 'Affiliation': ''}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Royse', 'Affiliation': ''}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'Trent M', 'Initials': 'TM', 'LastName': 'Guess', 'Affiliation': ''}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Ball', 'Affiliation': ''}, {'ForeName': 'Dana L', 'Initials': 'DL', 'LastName': 'Duren', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2020-0078']
2230,32788417,"The Effect of Kinesio Taping on Spasticity: A Randomized, Controlled, Double-Blind Pilot Study in Para-Swimmers.","CONTEXT


Kinesio Taping (KT) produces several clinical effects, including pain relief, edema absorption, and improved muscle performance. When applied in the insertion to origin mode, it is claimed to inhibit excessive muscle contractions.
OBJECTIVE


Investigate whether KT applied in the insertion to origin mode could reduce the exaggerated reflex contraction of spastic muscles.
DESIGN


Randomized crossover trial, with a restricted block randomization.
SETTING


Clinical laboratory and swimming pool.
PATIENTS


Seven para-swimmers.
INTERVENTION


KT, applied in inhibitory mode, to investigate its effect on knee extensor spasticity.
MAIN OUTCOME MEASURES


Primary outcome is stretch reflex, as compared with clinical assessment of spasticity by Modified Ashworth Scale and self-perceived spasticity by numeric rating scale. Secondary outcomes were Medical Research Council for strength of knee extensor muscles and chronometric swimming performance in 100-m freestyle.
RESULTS


KT significantly decreased the amplitude of stretch reflex (P < .001), whereas the placebo treatment produced no significant effects. Scores of Medical Research Council for strength and Modified Ashworth Scale did not change after KT, whereas numeric rating scale scores for spasticity significantly decreased (P = .001). The swimming performance was significantly improved after KT treatment as compared with baseline (P < .01).
CONCLUSIONS


This exploratory study performed on para-athletes suggests that KT could reduce spasticity. This outcome has 3-fold implications for clinical, rehabilitation, and sport methods.",2020,"RESULTS


KT significantly decreased the amplitude of stretch reflex (P < .001), whereas the placebo treatment produced no significant effects.","['Para-Swimmers', 'Seven para-swimmers']","['Kinesio Taping', 'Kinesio Taping (KT', 'KT', 'placebo']","['swimming performance', 'Scores of Medical Research Council for strength and Modified Ashworth Scale', 'amplitude of stretch reflex', 'pain relief, edema absorption, and improved muscle performance', 'spasticity', 'Spasticity', 'numeric rating scale scores for spasticity', 'stretch reflex, as compared with clinical assessment of spasticity by Modified Ashworth Scale and self-perceived spasticity by numeric rating scale', 'Medical Research Council for strength of knee extensor muscles and chronometric swimming performance in 100-m freestyle']","[{'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0450068', 'cui_str': 'Swimmer'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0034942', 'cui_str': 'Stretch reflex'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1704407', 'cui_str': '100'}]",,0.123743,"RESULTS


KT significantly decreased the amplitude of stretch reflex (P < .001), whereas the placebo treatment produced no significant effects.","[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Puce', 'Affiliation': ''}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Pallecchi', 'Affiliation': ''}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Marinelli', 'Affiliation': ''}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'May', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mori', 'Affiliation': ''}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Ruggeri', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Bove', 'Affiliation': ''}]",Journal of sport rehabilitation,['10.1123/jsr.2019-0504']
2231,32782729,Comparing the Efficacy of Methadone and Tincture of Opium in Controlling Agitation Caused by Withdrawal Syndrome in Opium-Addicted Patients in the Intensive Care Unit: A Randomized Trial Study.,"Background


Few studies have been conducted regarding the comparison of the efficacy of methadone and tincture of opium (TOP) in controlling agitation induced by withdrawal syndrome. Therefore, the current randomized trial study is carried out with the aim to evaluate comparisons on the efficacy of methadone and TOP in controlling agitation caused by withdrawal syndrome in opium addicted patients in the intensive care units (ICUs).
Methods


This clinical trial study was conducted on 60 patients admitted to ICU of Shahid Bahonar Hospital, Kerman, Iran. After classification of the patients into two groups, the first and second groups consumed methadone syrup (5 mg/ml) and TOP (10 mg/ml), respectively. Agitation in these patients was assessed through the Richmond Agitation-Sedation Scale (RASS). Vital signs were also assessed. Paired sample t-test and independent t-test were used for data analysis.
Findings


In the current study, the administered dose of methadone and TOP was 36.17 ± 26.99 and 112.67 ± 102.74 mg, respectively (P < 0.010). Methadone administration led to a significant decrease of the patients' vital signs, including systolic blood pressure, heart rate, respiratory rate, and Glasgow Coma Scale (GCS) (P < 0.05). Though TOP administration decreased systolic blood pressure and GCS significantly (P < 0.05), it had no effect on patients' diastolic blood pressure, body temperature, heart rate, and respiratory rate (P > 0.05). In total, no significant difference was detected between two groups regarding vital signs (P > 0.05). However, a significant difference was seen between methadone and TOP groups in terms of RASS score (P < 0.01).
Conclusion


According to the results of the current study, lower dose of methadone, compared to TOP, could control agitation caused by opium withdrawal symptoms.",2020,"Though TOP administration decreased systolic blood pressure and GCS significantly (P < 0.05), it had no effect on patients' diastolic blood pressure, body temperature, heart rate, and respiratory rate (P > 0.05).","['Opium-Addicted Patients in the Intensive Care Unit', 'opium addicted patients in the intensive care units (ICUs', '60 patients admitted to ICU of Shahid Bahonar Hospital, Kerman, Iran']","['methadone and TOP', 'TOP', 'methadone syrup', 'methadone', 'Methadone', 'Methadone and Tincture of Opium']","['vital signs', 'systolic blood pressure and GCS', 'RASS score', ""patients' diastolic blood pressure, body temperature, heart rate, and respiratory rate"", 'Richmond Agitation-Sedation Scale (RASS', ""patients' vital signs, including systolic blood pressure, heart rate, respiratory rate, and Glasgow Coma Scale (GCS""]","[{'cui': 'C0029112', 'cui_str': 'Opium'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0724655', 'cui_str': 'Laudanum'}, {'cui': 'C0458173', 'cui_str': 'Syrup'}]","[{'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",60.0,0.0649616,"Though TOP administration decreased systolic blood pressure and GCS significantly (P < 0.05), it had no effect on patients' diastolic blood pressure, body temperature, heart rate, and respiratory rate (P > 0.05).","[{'ForeName': 'Seyed Mojtaba', 'Initials': 'SM', 'LastName': 'Sohrevardi', 'Affiliation': 'Robarts Research Institute, University of Western Ontario, Ontario, Canada AND Pharmaceutical Sciences Research Center AND Department of Clinical Pharmacy, School of Pharmacy, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Pournamdari', 'Affiliation': 'Pharmaceutics Research Center AND Department of Medical Chemistry, School of Pharmacy, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Salimi', 'Affiliation': 'Pharmaceutics Research Center AND Department of Medical Chemistry, School of Pharmacy, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Sarrafzadeh', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Ahmadinejad', 'Affiliation': 'Department of Anesthesia, School of Medicine, Kerman University of Medical Sciences, Kerman, Iran.'}]",Addiction & health,['10.22122/ahj.v12i2.259']
2232,32782753,Renal function in the third year among very low birth weight infants fed by supplemental proteins.,"Very Low Birth Weight (VLBW) infants have higher nutritional needs than term infants. Energy and protein are two important factors influencing their growth. Breastfeeding is not enough to meet VLBW infants' needs, for this reason, complementary protein is required by them. Hence, the present study aimed at investigation of renal function among VLBW infants receiving complementary proteins. The study was conducted on two groups of intervention and control (n= 18 in each group) (Case study: VLBW infants born in Akbarabadi hospital of Tehran in 2014 2015). The intervention group includes 3-year-old children who weighting less than 1200 grams at birth and have received protein supplementation at the course of NICU hospitalization, protein was added to maternal milk when the amount of milk reaches to 100 cc/kg/day, at this time parenteral nutrition was discontinued and the volume of feeding was increased 20cc/kg/day until reached to 150-180cc/kg/day. We also added the fortifier to breast milk at this time. The fortification and the protein supplementation were stopped when the weight of the baby reached to 1500 grams. The control group was fed similar to the intervention group but had received no complementary protein . The renal function was evaluated by measuring such criteria as BUN, Cr, ALB and U/A. After data collection, a statistical analysis was performed using SPSS software Ver. 22. Following to BUN evaluation, a significant correlation was seen between BUN and received protein (p-value=0.010). However, there was no significant correlation between Cr and received protein as well as mean values of the two groups (p-value=0.0766). Similarly, an insignificant correlation was found between the two groups following to investigation of ALB (p-value=0/257), while the mean values of the two groups were similar. The both groups were also equal in U/A. The complementary protein increased the BUN with no effect on Cr, ALB and U/A, providing no impact on renal function. Therefore, complementary protein intake made no conflict in renal function.",2020,"The complementary protein increased the BUN with no effect on Cr, ALB and U/A, providing no impact on renal function.","['n= 18 in each group) (Case study: VLBW infants born in Akbarabadi hospital of Tehran in 2014 2015', 'VLBW infants receiving complementary proteins']","['3-year-old children who weighting less than 1200 grams at birth and have received protein supplementation', 'intervention group but had received no complementary protein ', 'intervention and control']","['renal function', 'Renal function']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085973', 'cui_str': 'Case Studies'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}]",,0.0150184,"The complementary protein increased the BUN with no effect on Cr, ALB and U/A, providing no impact on renal function.","[{'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Bordbar', 'Affiliation': 'Shahid Akbarabadi Clinical Research Development Unit, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azade Noroozi', 'Initials': 'AN', 'LastName': 'Vahid', 'Affiliation': 'Shahid Akbarabadi Clinical Research Development Unit, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mandana', 'Initials': 'M', 'LastName': 'Kashaki', 'Affiliation': 'Shahid Akbarabadi Clinical Research Development Unit, Iran University of Medical Sciences, Tehran, Iran.'}]",European journal of translational myology,['10.4081/ejtm.2019.8720']
2233,32782798,Effectiveness of behavioral activation for depression treatment in medical students: Study protocol for a quasi-experimental design.,"Introduction


Depression is a frequent mood disorder among medical students that can lead to multiple negative consequences at individual and social level (such as academic achievement and interpersonal conflicts) as well as patient care performance. Therefore, the need of depression decreasing treatments in medical students is important. This study is designed to evaluate the effectiveness of the Behavioral Activation Treatment for Depression in a sample of Mexican medical students.
Methods


This study will be performed under a quasi-experimental design to verify the effectiveness of the Behavioral Activation Treatment for Depression to reduce depressive symptoms in medical students from two public universities in northwestern Mexico. The participants will be assessed with the Center for Epidemiologic Studies Depression Scale, the Depression Anxiety Stress Scales, the Pittsburgh Sleep Quality Index, and the Plutchik Suicide Risk Scale. In addition to the psychometric assessment, there will be an electroencephalogram evaluation using the EMOTIV (v 1.1) device.
Results


A pre-post intervention of 10 Behavioral Activation Treatment for Depression sessions will be implemented. The results of the effectiveness of the Behavioral Activation Treatment for Depression will be analyzed in five measures at pre-post intervention and two follow-ups of 3 and 6 months.
Conclusions


This study looks for evidence regarding the efficacy and feasibility of the Behavioral Activation Treatment for Depression in a sample of medical students from two public universities in Mexico with high levels of depression along with stress and anxiety.",2020,"The results of the effectiveness of the Behavioral Activation Treatment for Depression will be analyzed in five measures at pre-post intervention and two follow-ups of 3 and 6 months.
","['Depression in a sample of medical students from two public universities in Mexico with high levels of depression along with stress and anxiety', 'medical students from two public universities in northwestern Mexico', 'medical students', 'Depression in a sample of Mexican medical students']","['behavioral activation', 'Behavioral Activation Treatment']","['Epidemiologic Studies Depression Scale, the Depression Anxiety Stress Scales, the Pittsburgh Sleep Quality Index, and the Plutchik Suicide Risk Scale']","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0451517', 'cui_str': 'Suicide risk scale'}]",10.0,0.0249002,"The results of the effectiveness of the Behavioral Activation Treatment for Depression will be analyzed in five measures at pre-post intervention and two follow-ups of 3 and 6 months.
","[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Domínguez Rodríguez', 'Affiliation': 'Valencia International University, Valencia, Spain.'}, {'ForeName': 'Gustavo Iván', 'Initials': 'GI', 'LastName': 'Martinez-Maqueda', 'Affiliation': 'Faculty of Medicine and Psychology, Autonomous University of Baja California, Tijuana, Mexico.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Arenas Landgrave', 'Affiliation': 'Faculty of Psychology, National Autonomous University of Mexico, Ciudad de México, Mexico.'}, {'ForeName': 'Sofía Cristina', 'Initials': 'SC', 'LastName': 'Martínez Luna', 'Affiliation': 'Faculty of Psychology, National Autonomous University of Mexico, Ciudad de México, Mexico.'}, {'ForeName': 'Flor Rocío', 'Initials': 'FR', 'LastName': 'Ramírez-Martínez', 'Affiliation': 'Institute of Biomedical Sciences, Autonomous University of Ciudad Juarez, Ciudad Juárez, México.'}, {'ForeName': 'Jasshel Teresa', 'Initials': 'JT', 'LastName': 'Salinas Saldivar', 'Affiliation': 'Institute of Biomedical Sciences, Autonomous University of Ciudad Juarez, Ciudad Juárez, México.'}]",SAGE open medicine,['10.1177/2050312120946239']
2234,32782813,Starch or Saline After Cardiac Surgery: A Double-Blinded Randomized Controlled Trial.,"Background


Despite decades of investigation, the balance of clinical risks and benefits of fluid supplementation with starch remain unresolved. Patient-centered outcomes have not been well explored in a ""real-world"" trial in cardiac surgery.
Objective


We sought to compare a starch-based fluid strategy with a saline-based fluid strategy in the cardiac surgery patient.
Design


A pragmatic blinded randomized controlled trial comparing starch-based with saline-based fluid strategy.
Setting


A large tertiary academic center in London Ontario between September 2009 and February 2011.
Participants


Patients undergoing planned, isolated coronary revascularization.
Measurements


Serum creatinine and patient weight were measured daily postoperatively.
Methods


Patients were randomized to receive 6% hydroxyethyl starch (Voluven) or saline for perioperative fluid requirements. Fluid administration was not protocolized. Co-primary outcomes were incidence of acute kidney injury (AKI) and maximum postoperative weight gain. Secondary outcomes included bleeding, transfusion, inotropic and ventilator support, and fluid utilization.
Results


The study was prematurely terminated due to resource limitations. A total of 69 patients (19% female, mean age = 65) were randomized. Using RIFLE criteria for AKI, ""risk"" occurred in 12 patients in each group (risk ratio [RR] = 1.0; 95% confidence interval [CI] = 0.5-1.9;  P  = 1.00), whereas ""injury"" occurred in 7 of 35 (20%) and 3 of 34 (9%) of patients in the starch and saline groups, respectively (RR = 2.3; 95% CI = 0.6-8.1;  P  = .31). Maximum weight gain, bleeding and blood product usage, and overall fluid requirement were similar between groups.
Limitations


The study had to be prematurely terminated due to resource limitations which led to a small sample size which was not sufficiently powered to detect a difference in the primary outcomes.
Conclusions


This pragmatic double-blinded randomized controlled trial revealed a number of interesting hypothesis-generating trends and confirmed the feasibility of undertaking a logistically complex trial in a pragmatic fashion.",2020,"Maximum weight gain, bleeding and blood product usage, and overall fluid requirement were similar between groups.
","['69 patients (19% female, mean age = 65', 'cardiac surgery patient', 'Participants\n\n\nPatients undergoing planned, isolated coronary revascularization', 'Setting\n\n\nA large tertiary academic center in London Ontario between September 2009 and February 2011']","['starch-based fluid strategy with a saline-based fluid strategy', '6% hydroxyethyl starch (Voluven) or saline', 'starch-based with saline-based fluid strategy', 'Starch or Saline']","['bleeding, transfusion, inotropic and ventilator support, and fluid utilization', 'injury', 'Maximum weight gain, bleeding and blood product usage, and overall fluid requirement', 'incidence of acute kidney injury (AKI) and maximum postoperative weight gain', 'Measurements\n\n\nSerum creatinine and patient weight']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}]","[{'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0020352', 'cui_str': 'Hetastarch'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0456388', 'cui_str': 'Blood product'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",69.0,0.807513,"Maximum weight gain, bleeding and blood product usage, and overall fluid requirement were similar between groups.
","[{'ForeName': 'A Dave', 'Initials': 'AD', 'LastName': 'Nagpal', 'Affiliation': 'Department of Surgery, Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cowan', 'Affiliation': 'Department of Medicine, Division of Nephrology, Western University, London, ON, Canada.'}, {'ForeName': 'Linna', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Surgery, Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON, Canada.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Nusca', 'Affiliation': 'Department of Surgery, Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON, Canada.'}, {'ForeName': 'Linrui', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Department of Surgery, Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON, Canada.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Novick', 'Affiliation': 'Department of Surgery, Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON, Canada.'}, {'ForeName': 'Chris C', 'Initials': 'CC', 'LastName': 'Harle', 'Affiliation': 'Department of Anesthesia & Perioperative Medicine, Western University, London, ON, Canada.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'House', 'Affiliation': 'Department of Medicine, Division of Nephrology, Western University, London, ON, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Fox', 'Affiliation': 'Department of Surgery, Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON, Canada.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Jones', 'Affiliation': 'Department of Anesthesia & Perioperative Medicine, Western University, London, ON, Canada.'}]",Canadian journal of kidney health and disease,['10.1177/2054358120940434']
2235,32782817,Study protocol: a lifestyle intervention for African American and Hispanic prostate cancer survivors on active surveillance and their partners.,"Background


Prostate cancer is the most commonly diagnosed cancer in both African American and Hispanic men. Active surveillance is a treatment option for low- or very low-risk prostate cancer survivors, and lifestyle interventions have been found to reduce the disease progression and improve the quality of life for both survivors and their partners. To date, no lifestyle interventions that specifically target African American or Hispanic men and their partners exist. This protocol describes a study that tests the feasibility of a randomized controlled trial, a lifestyle intervention developed to enhance healthy lifestyle and quality of life among African American and Hispanic men on active surveillance and their partners.
Methods


A mixed-method study, including a two-arm randomized controlled trial ( n  = 30 dyads in the intervention arm and  n  = 10 dyads in the control arm) and in-depth interviews, will be conducted. Intervention arm participants will receive bi-weekly health coaching calls (a total of 12 calls based on Motivational Interviewing), as well as physical activity-specific (e.g., power point slides, print materials about physical activity, and activity trackers for self-monitoring) and nutrition-specific education (e.g., two nutrition counseling sessions from a registered dietitian, print materials about nutrition, and food intake recording for self-monitoring) over 6 months. All participants will be assessed at baseline, month 3, and month 6. Blood will be collected at baseline and month 6 from the prostate cancer survivors. Finally, in-depth interviews will be conducted with subsamples (up to  n  = 15 dyads in the intervention arm and up to  n  = 5 dyads in the control arm) at baseline and months 3 and 6 to conduct a process evaluation and further refine the intervention.
Discussion


If effective, the intervention may have a higher health impact compared with a typical lifestyle intervention targeting only survivors (or partners), as it improves both survivors' (tertiary prevention) and partners' health (primary prevention). Results from this study will provide important information regarding recruiting racial/ethnic minority cancer survivors and their partners. Lessons learned from this study will be used to apply for a large-scale grant to test the impact of the dyadic intervention in a fully powered sample.
Trial registration


ClinicalTrials.gov (NCT No. 03575832) registered on 3 July 2018.",2020,"This protocol describes a study that tests the feasibility of a randomized controlled trial, a lifestyle intervention developed to enhance healthy lifestyle and quality of life among African American and Hispanic men on active surveillance and their partners.
","['African American and Hispanic prostate cancer survivors on active surveillance and their partners', 'African American and Hispanic men', 'African American and Hispanic men on active surveillance and their partners']","['Intervention arm participants will receive bi-weekly health coaching calls (a total of 12 calls based on Motivational Interviewing), as well as physical activity-specific (e.g., power point slides, print materials about physical activity, and activity trackers for self-monitoring) and nutrition-specific education (e.g., two nutrition counseling sessions from a registered dietitian, print materials about nutrition, and food intake recording for self-monitoring', 'lifestyle intervention']",['healthy lifestyle and quality of life'],"[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0332246', 'cui_str': 'Sliding'}, {'cui': 'C0034036', 'cui_str': 'Printed material'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3714365', 'cui_str': 'Nutrition counseling'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.067643,"This protocol describes a study that tests the feasibility of a randomized controlled trial, a lifestyle intervention developed to enhance healthy lifestyle and quality of life among African American and Hispanic men on active surveillance and their partners.
","[{'ForeName': 'Dalnim', 'Initials': 'D', 'LastName': 'Cho', 'Affiliation': 'Department of Health Disparities Research, UT Texas MD Anderson Cancer Center, 1400 Pressler St, 9th floor, Houston, TX 77030 USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Basen-Engquist', 'Affiliation': 'Department of Behavioral Science, UT Texas MD Anderson Cancer Center, Houston, TX USA.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Acquati', 'Affiliation': 'Graduate College of Social Work, University of Houston, Houston, TX USA.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Department of General Oncology, UT Texas MD Anderson Cancer Center, Houston, TX USA.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Pettaway', 'Affiliation': 'Department of Urology, UT Texas MD Anderson Cancer Center, Houston, TX USA.'}, {'ForeName': 'Yisheng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, UT Texas MD Anderson Cancer Center, Houston, TX USA.'}, {'ForeName': 'Cassandra S', 'Initials': 'CS', 'LastName': 'Diep', 'Affiliation': 'Kinesiology Department, Rice University, Houston, TX USA.'}, {'ForeName': 'Lorna H', 'Initials': 'LH', 'LastName': 'McNeill', 'Affiliation': 'Department of Health Disparities Research, UT Texas MD Anderson Cancer Center, 1400 Pressler St, 9th floor, Houston, TX 77030 USA.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00653-7']
2236,32782818,Pediatric size phlebotomy tubes and transfusions in adult critically ill patients: a pilot randomized controlled trial.,"Background


Transfusion of red blood cells (RBC) is common, can have adverse effects, and is a costly and limited resource. Interventions that reduce iatrogenic blood losses could reduce transfusions. The objectives of this pilot trial were to assess the feasibility (acceptability of the intervention and suitability of eligibility criteria) and potential effectiveness of pediatric size phlebotomy tubes in adult critically ill patients.
Methods


We conducted a pilot, randomized controlled trial in the medical intensive care unit (ICU) of a university-affiliated, tertiary care referral hospital from November 2017 to September 2018. A total of 200 patients with hemoglobin of at least 7 g/dL and without bleeding were randomized to pediatric or adult size phlebotomy tubes. Stratification was according to baseline hemoglobin (7-9.49 g/dL, 9.5-11.99 g/dL, and 12 g/dL or greater). Acceptability was measured via the number of blood test recollections and the number of patients that discontinued the use of pediatric tubes. The suitability of patient eligibility criteria was determined by identifying baseline characteristics associated with RBC transfusions. Potential effectiveness was estimated from the time to RBC transfusion or to hemoglobin level below 7 g/dL.
Results


The use of pediatric tubes was acceptable as patients experienced a low number of tests recollections (on average 1 every 57 days), and none of the participants discontinued their use. The baseline hemoglobin category was the only factor that appeared to be independently associated with RBC transfusions. A total of 6 patients (6%) in the pediatric tube group and 11 patients (11%) in the adult tube group (hazard ratio, 0.69; 95% CI, 0.25 to 1.9) received an RBC transfusion or reached hemoglobin below 7 g/dL. Almost all of these patients (16 of 17 participants) had baseline hemoglobin of 7-9.49 g/dL.
Conclusions


This pilot study suggests that pediatric phlebotomy tubes are acceptable to patients and can therefore be used in adult ICU patients. A future study should focus on patients with hemoglobin levels below 9.5 g/dL, as these patients have a high risk of transfusions. This intervention has the potential of being successful in selected patients. A definitive trial is warranted.
Trial registration


ClinicalTrials.gov, NCT03286465. Retrospectively registered on September 18, 2017.",2020,Acceptability was measured via the number of blood test recollections and the number of patients that discontinued the use of pediatric tubes.,"['adult ICU patients', 'medical intensive care unit (ICU) of a university-affiliated, tertiary care referral hospital from November 2017 to September 2018', '200 patients with hemoglobin of at least 7\u2009g/dL and without bleeding', 'patients with hemoglobin levels below 9.5\u2009g/dL, as these patients have a high risk of transfusions', 'adult critically ill patients']","['pediatric or adult size phlebotomy tubes', 'Pediatric size phlebotomy tubes and transfusions', 'pediatric size phlebotomy tubes']","['Acceptability', 'RBC transfusion or reached hemoglobin', 'iatrogenic blood losses', 'Potential effectiveness', 'baseline hemoglobin']","[{'cui': 'C0587445', 'cui_str': 'Adult intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711734', 'cui_str': 'Medical intensive care unit'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",200.0,0.204252,Acceptability was measured via the number of blood test recollections and the number of patients that discontinued the use of pediatric tubes.,"[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Barreda Garcia', 'Affiliation': 'Division of Critical Care Medicine, Department of Internal Medicine, The University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 1.434, Houston, TX 77030 USA.'}, {'ForeName': 'Jonathan Z', 'Initials': 'JZ', 'LastName': 'Xian', 'Affiliation': 'Division of Critical Care Medicine, Department of Internal Medicine, The University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 1.434, Houston, TX 77030 USA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pedroza', 'Affiliation': 'Center for Clinical Research and Evidence-Based Medicine, The University of Texas Health Science Center at Houston, Houston, TX USA.'}, {'ForeName': 'Moiz', 'Initials': 'M', 'LastName': 'Salahuddin', 'Affiliation': 'Division of Critical Care Medicine, Department of Internal Medicine, The University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 1.434, Houston, TX 77030 USA.'}, {'ForeName': 'Garbo', 'Initials': 'G', 'LastName': 'Mak', 'Affiliation': 'Division of Critical Care Medicine, Department of Internal Medicine, The University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 1.434, Houston, TX 77030 USA.'}, {'ForeName': 'Anabelle', 'Initials': 'A', 'LastName': 'Keene', 'Affiliation': 'Memorial Hermann Hospital Texas Medical Center, Houston, TX USA.'}, {'ForeName': 'Sujith V', 'Initials': 'SV', 'LastName': 'Cherian', 'Affiliation': 'Division of Critical Care Medicine, Department of Internal Medicine, The University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 1.434, Houston, TX 77030 USA.'}, {'ForeName': 'Alisha Y', 'Initials': 'AY', 'LastName': 'Young', 'Affiliation': 'Division of Critical Care Medicine, Department of Internal Medicine, The University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 1.434, Houston, TX 77030 USA.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Vijhani', 'Affiliation': 'Division of Critical Care Medicine, Department of Internal Medicine, The University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 1.434, Houston, TX 77030 USA.'}, {'ForeName': 'Pratik B', 'Initials': 'PB', 'LastName': 'Doshi', 'Affiliation': 'Division of Critical Care Medicine, Department of Internal Medicine, The University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 1.434, Houston, TX 77030 USA.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00657-3']
2237,32782966,"Low-dose melatonin for sleep disturbances in early-stage cirrhosis: A randomized, placebo-controlled, cross-over trial.","Background and aim


Melatonin is used to treat sleep disturbances (SDs). The aim of this study was to investigate the safety and efficacy of low-dose melatonin for SDs in early-stage cirrhosis.
Methods


In a single-center, randomized, double-blind, placebo-controlled, cross-over clinical trial, patients with early-stage (Child-Turcotte-Pugh [CTP] class A or B) cirrhosis with SDs, without hepatic encephalopathy, were randomized to placebo or 3 mg of melatonin for 2 weeks. After 2 weeks, the patients were given a washout period of 1 week and crossed over to melatonin or placebo for a further 2 weeks. The Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) were used to measure sleep quality and daytime sleepiness, respectively. Analysis of results was based on intention to treat, and linear mixed-effect models were used to evaluate the effect of melatonin. Analysis was conducted using R-programming language 3.5.1.
Results


Seventy one patients were recruited (mean age: 61.9 ± 8.7 years, males: 46 [64.8%], and CTP Class A = 52 [73.2%] and Class B = 19 [26.8%]). Sixty patients completed the study (mean age: 61.7 ± 8.8 years, males: 40 [66.6%], and CTP Class A = 45 [75.0%] and Class-B = 15 [25.0%]). Two patients dropped out due to adverse events. Nine patients were lost to follow up. Patients given melatonin had a significantly lower PSQI and ESS compared to both pretreatment ( P  < 0.001) and postplacebo scores ( P  < 0.001). Incidence of adverse events was similar (two each of abdominal pain, one each of headache, one each of dizziness) in both groups.
Conclusion


Melatonin seems safe and effective for use in patients with SDs in early-stage cirrhosis in the short term. However, larger and longer-term studies to assess efficacy and safety are required before its clinical use can be recommended.",2020,Patients given melatonin had a significantly lower PSQI and ESS compared to both pretreatment ( P  < 0.001) and postplacebo scores ( P  < 0.001).,"['early-stage cirrhosis', 'patients with early-stage (Child-Turcotte-Pugh [CTP] class A or B) cirrhosis with SDs, without hepatic encephalopathy', 'Sixty patients completed the study (mean age: 61.7\u2009±\u20098.8\u2009years, males: 40 [66.6%], and CTP Class A = 45 [75.0%] and Class-B = 15 [25.0', 'patients with SDs in early-stage cirrhosis in the short term', 'Results\n\n\nSeventy one patients were recruited (mean age: 61.9\u2009±\u20098.7\u2009years, males: 46 [64.8%], and CTP Class A = 52 [73.2%] and Class B = 19 [26.8']","['melatonin or placebo', 'Melatonin', 'low-dose melatonin', 'Low-dose melatonin', 'melatonin', 'placebo or 3 mg of melatonin', 'placebo']","['sleep disturbances', 'Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS', 'postplacebo scores', 'sleep quality and daytime sleepiness', 'safety and efficacy', 'PSQI and ESS', 'efficacy and safety', 'adverse events', 'Incidence of adverse events']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3889091', 'cui_str': 'Child-Turcotte-Pugh class A'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0019151', 'cui_str': 'Hepatic encephalopathy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0010734', 'cui_str': 'Cytidine triphosphate'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C4517880', 'cui_str': '8.7'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",71.0,0.511327,Patients given melatonin had a significantly lower PSQI and ESS compared to both pretreatment ( P  < 0.001) and postplacebo scores ( P  < 0.001).,"[{'ForeName': 'Arjuna P', 'Initials': 'AP', 'LastName': 'De Silva', 'Affiliation': 'Faculty of Medicine University of Kelaniya Ragama Sri Lanka.'}, {'ForeName': 'Madunil A', 'Initials': 'MA', 'LastName': 'Niriella', 'Affiliation': 'Faculty of Medicine University of Kelaniya Ragama Sri Lanka.'}, {'ForeName': 'Dileepa S', 'Initials': 'DS', 'LastName': 'Ediriweera', 'Affiliation': 'Faculty of Medicine University of Kelaniya Ragama Sri Lanka.'}, {'ForeName': 'Jerome P', 'Initials': 'JP', 'LastName': 'De Alwis', 'Affiliation': 'University Medical Unit Colombo North Teaching Hospital Ragama Sri Lanka.'}, {'ForeName': 'Isurujith K', 'Initials': 'IK', 'LastName': 'Liyanage', 'Affiliation': 'University Medical Unit Colombo North Teaching Hospital Ragama Sri Lanka.'}, {'ForeName': 'Ushanthani', 'Initials': 'U', 'LastName': 'Ettickan', 'Affiliation': 'Faculty of Medicine University of Kelaniya Ragama Sri Lanka.'}, {'ForeName': 'Kasun V', 'Initials': 'KV', 'LastName': 'Liyanapathirana', 'Affiliation': 'Faculty of Medicine University of Kelaniya Ragama Sri Lanka.'}, {'ForeName': 'Chandimani', 'Initials': 'C', 'LastName': 'Undugodage', 'Affiliation': 'Faculty of Medical Sciences University of Sri Jayawardenapura Nugegoda Sri Lanka.'}, {'ForeName': 'H Asita', 'Initials': 'HA', 'LastName': 'de Silva', 'Affiliation': 'Faculty of Medicine University of Kelaniya Ragama Sri Lanka.'}, {'ForeName': 'H Janaka', 'Initials': 'HJ', 'LastName': 'de Silva', 'Affiliation': 'Faculty of Medicine University of Kelaniya Ragama Sri Lanka.'}]",JGH open : an open access journal of gastroenterology and hepatology,['10.1002/jgh3.12356']
2238,32783051,Left atrial structure and function among different subtypes of atrial fibrillation: an echocardiographic substudy of the AMIO-CAT trial.,"AIMS 


Little is known about cardiac structure and function among atrial fibrillation (AF) subtypes; paroxysmal AF vs. persistent AF (PxAF), and across AF burden. We sought to assess differences in left atrial (LA) measures by AF subtype and burden.
METHODS AND RESULTS 


This was a cross-sectional echocardiographic substudy of a randomized trial of AF patients scheduled for catheter ablation. Patients had an echocardiogram performed 0-90 days prior to study inclusion. We performed conventional echocardiographic measures, left ventricular (LV) and LA speckle tracking. Measures were compared between AF subtype and burden (0%, 0-99%, and 99-100%) determined by 72-h Holter monitoring. Of 212 patients, 107 had paroxysmal AF and 105 had PxAF. Those with PxAF had significantly reduced systolic function (LV ejection fraction: 48% vs. 53%; P < 0.001), larger end-systolic and end-diastolic LA volumes (LAVi and LAEDVi), reduced LA emptying fraction (LAEF: 29% vs. 36%, P < 0.001), and reduced LA strain (LAs) (LAs: 20% vs. 26%, P < 0.001). LA measures remained significantly lower in PxAF after multivariable adjustments. All LA measures and measures of systolic function were significantly impaired in patients with 99-100% AF burden, whereas all measures were similar between the other groups (LAVi: 40mL/m2 vs. 33mL/m2 vs. 34mL/m2; LAEDVi: 31mL/m2 vs. 21mL/m2 vs. 22mL/m2, LA emptying fraction: 23% vs. 35% vs. 36%, LAs: 16% vs. 25% vs. 25%, for 99-100%, 0-99%, and 0% AF, respectively, P < 0.001 for all). These differences were consistent after multivariable adjustments.
CONCLUSION 


LA mechanics differ between AF subtype and burden and these characteristics influence the clinical interpretation of these measures.",2020,"Those with PxAF had significantly reduced systolic function (LV ejection fraction: 48% vs. 53%; P < 0.001), larger end-systolic and end-diastolic LA volumes (LAVi and LAEDVi), reduced LA emptying fraction (LAEF: 29% vs. 36%, P < 0.001), and reduced LA strain (LAs) (LAs: 20% vs. 26%, P < 0.001).","['Of 212 patients, 107 had paroxysmal AF and 105 had PxAF']","['conventional echocardiographic measures, left ventricular (LV) and LA speckle tracking', 'AF patients scheduled for catheter ablation']","['reduced LA strain (LAs', 'LA measures', 'larger end-systolic and end-diastolic LA volumes (LAVi and LAEDVi), reduced LA emptying fraction', 'All LA measures and measures of systolic function', 'left atrial (LA) measures by AF subtype and burden', 'systolic function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0439691', 'cui_str': 'Speckled'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}]",212.0,0.101298,"Those with PxAF had significantly reduced systolic function (LV ejection fraction: 48% vs. 53%; P < 0.001), larger end-systolic and end-diastolic LA volumes (LAVi and LAEDVi), reduced LA emptying fraction (LAEF: 29% vs. 36%, P < 0.001), and reduced LA strain (LAs) (LAs: 20% vs. 26%, P < 0.001).","[{'ForeName': 'Flemming Javier', 'Initials': 'FJ', 'LastName': 'Olsen', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 1, 2900 Hellerup, Denmark.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Darkner', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Pehrson', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Johannessen', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 1, 2900 Hellerup, Denmark.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Hansen', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 1, 2900 Hellerup, Denmark.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Gislason', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 1, 2900 Hellerup, Denmark.'}, {'ForeName': 'Jesper Hastrup', 'Initials': 'JH', 'LastName': 'Svendsen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Tor', 'Initials': 'T', 'LastName': 'Biering-Sørensen', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 1, 2900 Hellerup, Denmark.'}]",European heart journal cardiovascular Imaging,['10.1093/ehjci/jeaa222']
2239,32783084,[Alleviating radiation-induced xerostomia with chewing gum: a randomized phase III trial].,,2020,,[],['Alleviating radiation-induced xerostomia with chewing gum'],[],[],"[{'cui': 'C1275047', 'cui_str': 'Radiation-induced xerostomia'}, {'cui': 'C0008037', 'cui_str': 'Chewing Gum'}]",[],,0.016268,,"[{'ForeName': 'Robert Michael', 'Initials': 'RM', 'LastName': 'Hermann', 'Affiliation': 'Zentrum für Strahlentherapie und Radioonkologie, Mozartstr.\xa030, 26655, Westerstede, Deutschland. hermann@strahlentherapie-westerstede.com.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Christiansen', 'Affiliation': 'Klinik für Strahlentherapie und Spezielle Onkologie, Medizinische Hochschule Hannover, Hannover, Deutschland.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01673-1']
2240,32783125,Functional Voice and Swallowing Outcome Analysis After Thyroid Lobectomy: Transoral Endoscopic Vestibular Versus Open Approach.,"BACKGROUND


The transoral endoscopic thyroidectomy vestibular approach (TOETVA) is a scarless remote-access thyroidectomy technique. This study compared subjective and objective voice outcomes and swallowing outcomes of patients who underwent thyroid lobectomy using the TOETVA versus conventional open thyroidectomy (OT).
METHODS


In addition to questionnaires, acoustic and aerodynamic analyses were performed to compare subjective and objective voice outcomes of the two groups. Swallowing outcome analyses were conducted using Swallowing Impairment Index-6 (SIS-6) scores. Assessments were performed preoperatively and 3 and 6 months after surgery. Propensity score matching was performed to compare the outcomes of the two groups.
RESULTS


One hundred and two patients were included in this study (52 TOETVA and 50 OT). Excluding two patients who had vocal cord palsy and open conversion in the TOETVA group, 100 patients completed 3-month postoperative surveys. There were no significant differences between the groups in VAS, GRBAS, or VHI-10 scores at the preoperative and 3- and 6-month assessments. For both groups, there were no significant changes in acoustic or aerodynamic parameters during the 3-6-month postoperative period. The TOETVA group had lower SIS-6 scores at the postoperative 6-month assessment, but the SIS-6 scores after 12 months were similar between groups before and after propensity score matching.
CONCLUSIONS


Following TOETVA lobectomy, there were no significant changes in voice outcomes 3 and 6 months after surgery, and the outcomes were comparable with those of OT. The TOETVA group also had swallowing outcomes that were comparable with the OT group.",2020,"For both groups, there were no significant changes in acoustic or aerodynamic parameters during the 3-6-month postoperative period.","['Excluding two patients who had vocal cord palsy and open conversion in the TOETVA group, 100 patients completed 3-month postoperative surveys', 'patients who underwent', 'One hundred and two patients were included in this study (52 TOETVA and 50 OT']","['thyroid lobectomy using the TOETVA versus conventional open thyroidectomy (OT', 'transoral endoscopic thyroidectomy vestibular approach (TOETVA', 'Thyroid Lobectomy: Transoral Endoscopic Vestibular Versus Open Approach']","['Functional Voice and Swallowing Outcome Analysis', 'lower SIS-6 scores', 'Swallowing Impairment Index-6 (SIS-6) scores', 'VAS, GRBAS, or VHI-10 scores', 'SIS-6 scores', 'subjective and objective voice outcomes', 'swallowing outcomes', 'subjective and objective voice outcomes and swallowing outcomes', 'acoustic or aerodynamic parameters', 'voice outcomes']","[{'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042928', 'cui_str': 'Vocal cord paralysis'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0392678', 'cui_str': 'Swallowing problem'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",102.0,0.0264362,"For both groups, there were no significant changes in acoustic or aerodynamic parameters during the 3-6-month postoperative period.","[{'ForeName': 'Sungjun', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': ""Department of Otorhinolaryngology-Head and Neck Surgery, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Tack-Kyun', 'Initials': 'TK', 'LastName': 'Kwon', 'Affiliation': 'Department of Otolaryngology, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Young Jun', 'Initials': 'YJ', 'LastName': 'Chai', 'Affiliation': 'Department of Surgery, Seoul Metropolitan Government Seoul National University Boramae Medical Center, 20 Boramaep-ro 5-gil, Dongjak-gu, Seoul, 07061, Republic of Korea. kevinjoon1@gmail.com.'}, {'ForeName': 'Jina', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Biostatistics, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Doh Young', 'Initials': 'DY', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Kyu Eun', 'Initials': 'KE', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Seoul National University Hospital and College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hoon Yub', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, KUMC Thyroid Center, Korea University Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ki-Tae', 'Initials': 'KT', 'LastName': 'Hwang', 'Affiliation': 'Department of Surgery, Seoul Metropolitan Government Seoul National University Boramae Medical Center, 20 Boramaep-ro 5-gil, Dongjak-gu, Seoul, 07061, Republic of Korea.'}, {'ForeName': 'Ka Hee', 'Initials': 'KH', 'LastName': 'Yi', 'Affiliation': 'Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Republic of Korea.'}]",World journal of surgery,['10.1007/s00268-020-05731-8']
2241,32783178,Treatment effect of palbociclib plus endocrine therapy by prognostic and intrinsic subtype and biomarker analysis in patients with bone-only disease: a joint analysis of PALOMA-2 and PALOMA-3 clinical trials.,"PURPOSE


This analysis evaluated the relationship between treatment-free interval (TFI, in PALOMA-2)/disease-free interval (DFI, in PALOMA-3) and progression-free survival (PFS) and overall survival (OS, in PALOMA-3), treatment effect in patients with bone-only disease, and whether intrinsic subtype affects PFS in patients receiving palbociclib.
METHODS


Data were from phase 3, randomized PALOMA-2 and PALOMA-3 clinical studies of hormone receptor‒positive/human epidermal growth factor receptor 2‒negative (HR+ /HER2-) advanced breast cancer (ABC) patients receiving endocrine therapy plus palbociclib or placebo. Subpopulation treatment effect pattern plot (STEPP) analysis evaluated the association between DFI and PFS and OS. PFS by luminal subtype and cyclin-dependent kinase (CDK) 4/6 or endocrine pathway gene expression levels were evaluated in patients with bone-only disease; median PFS and OS were estimated by the Kaplan-Meier method.
RESULTS


Median durations of TFI were 37.1 and 30.9 months (PALOMA-2) and DFI were 49.2 and 52.0 months (PALOMA-3) in the palbociclib and placebo groups, respectively. Among the PALOMA-2 biomarker population (n = 454), 23% had bone-only disease; median PFS was longer with palbociclib versus placebo (31.3 vs 11.2 months; hazard ratio, 0.41; 95% CI 0.25‒0.69). The interaction effect of bone-only versus visceral disease subgroups on median PFS with palbociclib was not significant (P = 0.262). Among the PALOMA-3 biomarker population (n = 302), 27% had bone-only disease. STEPP analyses showed that palbociclib PFS benefit was not affected by DFI, and that palbociclib OS effect may be smaller in patients with short DFIs. Among patients who provided metastatic tumor tissues (n = 142), regardless of luminal A (hazard ratio, 0.23; 95% CI 0.11‒0.47; P = 0.0000158) or luminal B (hazard ratio, 0.26; 95% CI 0.12‒0.56; P = 0.000269) subtype, palbociclib improved PFS versus placebo.
CONCLUSIONS


These findings support palbociclib plus endocrine therapy as standard of care for HR+ /HER2- ABC patients, regardless of baseline TFI/DFI or intrinsic molecular subtype, including patients with bone-only disease.
TRIAL REGISTRATION


Pfizer (clinicaltrials.gov:NCT01740427, NCT01942135).",2020,The interaction effect of bone-only versus visceral disease subgroups on median PFS with palbociclib was not significant (P = 0.262).,"['advanced breast cancer (ABC) patients receiving', 'patients with short DFIs', 'patients with bone-only disease']","['palbociclib plus endocrine therapy', 'endocrine therapy plus palbociclib or placebo', 'plot (STEPP', 'hormone receptor‒positive/human epidermal growth factor receptor 2‒negative (HR+\u2009/HER2', 'placebo']","['bone-only disease; median PFS', 'DFI and PFS and OS', '4/6 or endocrine pathway gene expression levels', 'bone-only disease', 'median PFS with palbociclib', 'PFS by luminal subtype and cyclin-dependent kinase (CDK', 'treatment-free interval (TFI, in PALOMA-2)/disease-free interval (DFI, in PALOMA-3) and progression-free survival (PFS) and overall survival', 'Median durations of TFI', 'palbociclib PFS benefit']","[{'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C1509244', 'cui_str': 'human epidermal growth factor'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0243045', 'cui_str': 'cdk Proteins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.323609,The interaction effect of bone-only versus visceral disease subgroups on median PFS with palbociclib was not significant (P = 0.262).,"[{'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': 'Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, 2825 Santa Monica Blvd, Suite 200, Santa Monica, CA, USA. RFinn@mednet.ucla.edu.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Cristofanilli', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center, Feinberg School of Medicine, 710 N Fairbanks Ct, Suite 8-250A, Chicago, IL, USA.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Ettl', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Klinikum Rechts der Isar, Technical University of Munich, Ismaninger Str 22, 81675, Munich, Germany.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Gelmon', 'Affiliation': 'British Columbia Cancer Agency, 675 West 10th Ave, Vancouver, BC, Canada.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'IEO European Institute of Oncology, IRCCS, Via Ripamonti 435, Milan, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Giorgetti', 'Affiliation': 'Pfizer Italia, Via Anna Maria Mozzoni, 12, Milan, Italy.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Gauthier', 'Affiliation': 'Pfizer Inc, 525 Market Street, San Francisco, CA, USA.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Pfizer Inc, 10646 Science Center Dr, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Dongrui R', 'Initials': 'DR', 'LastName': 'Lu', 'Affiliation': 'Pfizer Inc, 10646 Science Center Dr, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Pfizer Inc, 10646 Science Center Dr, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Cynthia Huang', 'Initials': 'CH', 'LastName': 'Bartlett', 'Affiliation': 'Pfizer Inc, 500 Arcola Rd, Collegeville, PA, USA.'}, {'ForeName': 'Dennis J', 'Initials': 'DJ', 'LastName': 'Slamon', 'Affiliation': 'Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, 2825 Santa Monica Blvd, Suite 200, Santa Monica, CA, USA.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Turner', 'Affiliation': 'Royal Marsden Hospital and Institute of Cancer Research, Fulham Rd, London, SW3 6JJ, UK.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California San Francisco Comprehensive Center, 1600 Divisadero St, San Francisco, CA, USA.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05782-4']
2242,32343977,Clinical feasibility of a new antireflux ablation therapy on gastroesophageal reflux disease (with video).,"BACKGROUNDS AND AIMS


New mucosal resective and ablative endoscopic procedures based on gastric cardiac remodeling to prevent reflux have appeared. We aimed to evaluate the feasibility of a new ablative technique named antireflux ablation therapy (ARAT) for control of GERD in patients without hiatal hernia.
METHODS


Patients with proton pump inhibitor (PPI)-refractory GERD without hiatal hernia underwent ARAT between January 2016 and October 2019. Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL), upper endoscopy, 24-hour pH monitoring, and PPI use were documented at 3, 6, 12, 24, and 36 months after ARAT.
RESULTS


One hundred eight patients were included (61 men [56.5%]; median age, 36.5 years; range, 18-78 years). ARAT was performed on all patients. At the 36-month evaluation, 84 patients had completed the protocol. Median ARAT time was 35.5 minutes (range, 22-51 minutes), and median circumference ablation was 300° (range, 270°-320°). No major adverse events occurred, and 14 of 108 patients (12.9%) presented with stenosis that was responsive to balloon dilation (<5 sessions). At the 3-month evaluation, the acid exposure time (AET), DeMeester score, and GERD-HRQL score had decreased from 18.8% to 2.8% (P = .001), 42.5 to 9.1 (P = .001), and 36.5 to 10 (P = .02), respectively, and these values were maintained up to 36 months. Success (AET <4%) was achieved in 89% and 72.2% at 3 and 36 months, respectively. Related factors at 36 months were as follows: pre-ARAT Hill type II (odds ratio [OR], 3.212; 95% confidence interval [CI], 1.431-5.951; P = .033), post-ARAT 3-month Hill type I (OR, 4.101; 95% CI, 1.812-9.121; P = .042), and AET <4% at 3 months (OR, 5.512; 95% CI, 1.451-7.621; P = .021).
CONCLUSIONS


ARAT is a feasible, safe, and effective therapy for early and mid-term treatment of GERD in patients without a sliding hiatal hernia. However, longer follow-up evaluations and randomized comparative studies are needed to clarify its real role. (Clinical trial registration number: NCT03548298.).",2020,"I (OR, 4.101; 95% CI, 1.812-9.121; P = .042), and AET <4% at 3 months (OR, 5.512; 95% CI, 1.451-7.621; P = .021).
","['84 patients had completed the protocol', 'patients without hiatal hernia', 'patients without a sliding hiatal hernia', 'Patients with proton pump inhibitor (PPI)-refractory GERD without hiatal hernia underwent ARAT between January 2016 and October 2019', 'One hundred eight patients were included (61 men [56.5%]; median age, 36.5 years; range, 18-78 years']","['new antireflux ablation therapy', 'new ablative technique named antireflux ablation therapy (ARAT', 'ARAT']","['Median ARAT\xa0time', 'gastroesophageal reflux disease', 'adverse events', 'Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL), upper endoscopy, 24-hour pH monitoring, and PPI use', 'acid exposure time (AET), DeMeester score, and\xa0GERD-HRQL score', 'median circumference ablation']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3489393', 'cui_str': 'Hiatal hernia'}, {'cui': 'C0376710', 'cui_str': 'Sliding hiatus hernia'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0027365', 'cui_str': 'Name'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0017195', 'cui_str': 'Endoscopy of stomach'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}]",108.0,0.105267,"I (OR, 4.101; 95% CI, 1.812-9.121; P = .042), and AET <4% at 3 months (OR, 5.512; 95% CI, 1.451-7.621; P = .021).
","[{'ForeName': 'Oscar Víctor', 'Initials': 'OV', 'LastName': 'Hernández Mondragón', 'Affiliation': 'Division of Endoscopy, Specialties Hospital, National Medical Center Century XXI, Mexico City, Mexico.'}, {'ForeName': 'Raúl Antonio', 'Initials': 'RA', 'LastName': 'Zamarripa Mottú', 'Affiliation': 'Division of Endoscopy, Specialties Hospital, National Medical Center Century XXI, Mexico City, Mexico.'}, {'ForeName': 'Luís Fernando', 'Initials': 'LF', 'LastName': 'García Contreras', 'Affiliation': 'Division of Endoscopy, Specialties Hospital, National Medical Center Century XXI, Mexico City, Mexico.'}, {'ForeName': 'Raul Alberto', 'Initials': 'RA', 'LastName': 'Gutiérrez Aguilar', 'Affiliation': 'Division of Endoscopy, Specialties Hospital, National Medical Center Century XXI, Mexico City, Mexico.'}, {'ForeName': 'Omar Michel', 'Initials': 'OM', 'LastName': 'Solórzano Pineda', 'Affiliation': 'Division of Endoscopy, Specialties Hospital, National Medical Center Century XXI, Mexico City, Mexico.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Blanco Velasco', 'Affiliation': 'Division of Endoscopy, Specialties Hospital, National Medical Center Century XXI, Mexico City, Mexico.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Murcio Perez', 'Affiliation': 'Division of Endoscopy, Specialties Hospital, National Medical Center Century XXI, Mexico City, Mexico.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.04.046']
2243,30596265,Social Media Vaccine Websites: A Comparative Analysis of Public and Moderated Websites.,"The internet is an important source of vaccine information for parents. We evaluated and compared the interactive content on an expert moderated vaccine social media (VSM) website developed for parents of children 24 months of age or younger and enrolled in a health care system to a random sample of interactions extracted from publicly available parenting and vaccine-focused blogs and discussion forums. The study observation period was September 2013 through July 2016. Three hundred sixty-seven eligible websites were located using search terms related to vaccines. Seventy-nine samples of interactions about vaccines on public blogs and discussion boards and 61 interactions from the expert moderated VSM website were coded for tone, vaccine stance, and accuracy of information. If information was inaccurate, it was coded as corrected, partially corrected or uncorrected. Using chi-square or Fisher's exact tests, we compared coded interactions from the VSM website with coded interactions from the sample of publicly available websites. We then identified representative quotes to illustrate the quantitative results. Tone, vaccine stance, and accuracy of information were significantly different (all p < .05). Publicly available vaccine websites tended to be more contentious and have a negative stance toward vaccines. These websites also had inaccurate and uncorrected information. In contrast, the expert moderated website had a more civil tone, minimal posting of inaccurate information, with very little participant-to-participant interaction. An expert moderated, interactive vaccine website appears to provide a platform for parents to gather accurate vaccine information, express their vaccine concerns and ask questions of vaccine experts.",2019,"Tone, vaccine stance, and accuracy of information were significantly different (all p < .05).","['parents', 'Three hundred sixty-seven eligible websites', 'parents of children 24 months of age or younger and enrolled in a health care system to a random sample of interactions extracted from publicly available parenting and vaccine-focused blogs and discussion forums']","['expert moderated vaccine social media (VSM) website', 'Social Media Vaccine Websites']","['Tone, vaccine stance, and accuracy of information']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C2718045', 'cui_str': 'Blogs as Topic'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",,0.026545,"Tone, vaccine stance, and accuracy of information were significantly different (all p < .05).","[{'ForeName': 'Jo Ann', 'Initials': 'JA', 'LastName': 'Shoup', 'Affiliation': '1 Kaiser Permanente Colorado, Denver, CO, USA.'}, {'ForeName': 'Komal J', 'Initials': 'KJ', 'LastName': 'Narwaney', 'Affiliation': '1 Kaiser Permanente Colorado, Denver, CO, USA.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Wagner', 'Affiliation': '1 Kaiser Permanente Colorado, Denver, CO, USA.'}, {'ForeName': 'Courtney R', 'Initials': 'CR', 'LastName': 'Kraus', 'Affiliation': '1 Kaiser Permanente Colorado, Denver, CO, USA.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Gleason', 'Affiliation': '1 Kaiser Permanente Colorado, Denver, CO, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Albright', 'Affiliation': '2 University of Denver, Denver, CO, USA.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Glanz', 'Affiliation': '1 Kaiser Permanente Colorado, Denver, CO, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198118818253']
2244,32780594,An Israeli RCT of PEERS®: Intervention Effectiveness and the Predictive Value of Parental Sensitivity.,"OBJECTIVES


A Randomized Controlled Trial was conducted to evaluate the effectiveness of the Hebrew adaptation of the Program for the Education and Enrichment of Relational Skills (PEERS®), a parent-assisted intervention. Parental sensitivity (PS), measured in conflict and support contexts, was assessed as a predictor of adolescents' intervention-related outcomes.
DESIGN


Eighty-two Hebrew-speaking adolescents (9 females), aged 12-17 years, and their parents (62 mothers), were randomly allocated into immediate intervention (II; n = 40) or delayed intervention control (DI; n = 42) groups. Participants were tested at three time-points (Pre-Post-Follow Up for II, Pre-Pre-Post for DI). Outcome measures included behavioral assessments of adolescents' social communication (SC), a social-skills knowledge test, and self, parent, and teacher reported questionnaires. PS was assessed using support and conflict parent-adolescent interactions. Repeated measures ANOVAs were used to assess intervention effectiveness. SEM was used to examine PS pre- and post-intervention as predictors of adolescents' immediate and follow-up outcomes.
RESULTS


The II group improved on adolescents' measured SC and social knowledge, on parent-(but not teacher-) reported social skills, and on self-reported empathy. Gains maintained at follow-up. The DI group showed similar gains following their intervention. Adolescents' intervention-related SC gains were negatively predicted by pre-intervention PS, and positively predicted by intervention-related PS changes in the support context. Pre-intervention PS in the conflict context positively predicted adolescent SC at follow-up.
CONCLUSIONS


The Hebrew-adapted PEERS® is an effective intervention for adolescents with ASD. PS plays an important role in the promotion of SC in adolescents with ASD and should receive clinical attention.",2020,"SEM was used to examine PS pre- and post-intervention as predictors of adolescents' immediate and follow-up outcomes.
","['Eighty-two Hebrew-speaking adolescents (9 females), aged 12-17\xa0years, and their parents (62 mothers', 'adolescents with ASD']","['Relational Skills (PEERS®', 'Hebrew-adapted PEERS®', 'immediate intervention (II; n =\xa040) or delayed intervention control']","[""behavioral assessments of adolescents' social communication (SC), a social-skills knowledge test, and self, parent, and teacher reported questionnaires"", ""adolescents' measured SC and social knowledge, on parent-(but not teacher-) reported social skills, and on self-reported empathy"", 'Parental sensitivity (PS']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0018863', 'cui_str': 'Hebrew language'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}]","[{'cui': 'C0018863', 'cui_str': 'Hebrew language'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1160858', 'cui_str': 'Behavior assessment'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.0399627,"SEM was used to examine PS pre- and post-intervention as predictors of adolescents' immediate and follow-up outcomes.
","[{'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Rabin', 'Affiliation': 'Department of Psychology, Bar-Ilan University.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Laugeson', 'Affiliation': 'UCLA PEERS® Clinic, Semel Institute for Neuroscience and Human Behavior, UCLA.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Mor-Snir', 'Affiliation': 'The Autism Treatment and Research Center, Association for Children at Risk.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Golan', 'Affiliation': 'Department of Psychology, Bar-Ilan University.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2020.1796681']
2245,32780605,"Does Bilevel Noninvasive Ventilation Have a Bronchodilating Effect and Alter Respiratory Mechanics in Asthmatic Individuals After Bronchoprovocation? Randomized, Crossover Study.","Background:  Noninvasive ventilation (NIV) has an additional important effect that does not occur with medicinal therapy: a reduction in the work of breathing. Understanding the mechanical effects of these therapies is of considerable importance and can affect clinical decision making.  Objective:  Evaluate the effects of NIV compared to albuterol on lung function and respiratory mechanics in asthmatic adolescents and young adults after bronchoprovocation and determine the effects of a hypertonic saline solution on lung function respiratory mechanics.  Methods:  A randomized crossover study was conducted involving individuals with a diagnosis of asthma. Evaluations were performed with optoelectronic plethysmography (OEP) and spirometry at baseline, after the bronchial provocation test with 4.5% saline solution and after the intervention. The order of the procedures (bilevel NIV and albuterol) was randomized, with the participants crossing over to the other treatment after a 1-week washout period. Inspiratory positive airway pressure (IPAP) 12 and expiratory positive airway pressure (EPAP) 8 cmH 2 O were set for 10 minutes and the dose of albuterol was 400 μg.  Results:  Forty individuals were included in the study (mean age: 21.6 ± 4 years; 24 females). The recovery of FEV 1 % was 87.9% (80.8 ± 35 to 101.1 ± 46.1,  p  < 0.05) after NIV and 95.9% (84.4 ± 42.4 to 110.3 ± 44.3,  p  < 0.05) after albuterol. Inspiratory capacity (IC; L) reduced 12% to 15% after bronchoprovocation, with 100% recovery using NIV (2.1 ± 0.7 to 2.42.4 ± 0.6,  p  < 0.05) and 107.6% using albuterol (2.2 ± 0.8 to 2.8 ± 1.1,  p  < 0.05). Regarding OEP variables, tidal volume had greater participation in the thoracic compartment. NIV led to an increase in minute volume and a return to the baseline value, which did not occur with albuterol.  Conclusion:  NIV recovered FEV 1  and improves signs of hyperinflation by improving IC. Bronchoprovocation with a hypertonic solution reduced FEV 1  by 20% and reduced IC. NIV led to a faster recovery of minute volume and reduced the contraction velocity of the muscles of the rib cage compared to albuterol, although the effects on lung function were less intense.",2020,"NIV led to a faster recovery of minute volume and reduced the contraction velocity of the muscles of the rib cage compared to albuterol, although the effects on lung function were less intense.","['individuals with a diagnosis of asthma', 'asthmatic adolescents and young adults after bronchoprovocation', 'Asthmatic Individuals', 'Forty individuals were included in the study (mean age: 21.6\u2009±\u20094 years; 24 females']","['hypertonic saline solution', 'hypertonic solution', ':  Noninvasive ventilation (NIV', 'albuterol', 'NIV']","['contraction velocity', 'signs of hyperinflation by improving IC', 'Inspiratory positive airway pressure (IPAP) 12 and expiratory positive airway pressure (EPAP) 8 cmH', 'Inspiratory capacity (IC; L', 'lung function and respiratory mechanics', 'recovery of FEV', 'lung function', 'optoelectronic plethysmography (OEP) and spirometry', 'minute volume']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0020554', 'cui_str': 'Hypertonic solutions'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0751673', 'cui_str': 'Nipah virus'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}]","[{'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0020449', 'cui_str': 'Hyperdistention'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C3697361', 'cui_str': 'Expiratory positive airway pressure'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0021610', 'cui_str': 'Inspiratory capacity'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0428679', 'cui_str': 'Minute volume'}]",40.0,0.088193,"NIV led to a faster recovery of minute volume and reduced the contraction velocity of the muscles of the rib cage compared to albuterol, although the effects on lung function were less intense.","[{'ForeName': 'Evelim Leal de Freitas Dantas', 'Initials': 'ELFD', 'LastName': 'Gomes', 'Affiliation': 'Rehabilitation Sciences Program, Universidade Nove de Julho (UNINOVE), São Paulo, Brazil.'}, {'ForeName': 'Carla Lima Feitosa', 'Initials': 'CLF', 'LastName': 'Cavassini', 'Affiliation': 'Rehabilitation Sciences Program, Universidade Nove de Julho (UNINOVE), São Paulo, Brazil.'}, {'ForeName': 'Maisi Cabral Muniz', 'Initials': 'MCM', 'LastName': 'David', 'Affiliation': 'Rehabilitation Sciences Program, Universidade Nove de Julho (UNINOVE), São Paulo, Brazil.'}, {'ForeName': 'Josiane Germano', 'Initials': 'JG', 'LastName': 'Luiz', 'Affiliation': 'Rehabilitation Sciences Program, Universidade Nove de Julho (UNINOVE), São Paulo, Brazil.'}, {'ForeName': 'Adriana do Carmo', 'Initials': 'ADC', 'LastName': 'Santos', 'Affiliation': 'Rehabilitation Sciences Program, Universidade Nove de Julho (UNINOVE), São Paulo, Brazil.'}, {'ForeName': 'Aldenice Magalhães', 'Initials': 'AM', 'LastName': 'Capeletti', 'Affiliation': 'Rehabilitation Sciences Program, Universidade Nove de Julho (UNINOVE), São Paulo, Brazil.'}, {'ForeName': 'Dirceu', 'Initials': 'D', 'LastName': 'Costa', 'Affiliation': 'Rehabilitation Sciences Program, Universidade Nove de Julho (UNINOVE), São Paulo, Brazil.'}]",Journal of aerosol medicine and pulmonary drug delivery,['10.1089/jamp.2020.1608']
2246,32789215,Training with an Electric Exercise Bike versus a Conventional Exercise Bike during Hemodialysis for Patients with End-stage Renal Disease: A Randomized Clinical Trial.,"Objective


Hemodialysis (HD) patients have lower fitness levels than healthy subjects because of various structural, metabolic, and functional abnormalities secondary to uremic changes in skeletal muscles. Aerobic and resistance exercises are beneficial in improving not only physical function, including maximal oxygen uptake and muscle strength, but also anthropometrics, nutritional status, and hematologic indices. The use of electric ergometers that place light loads on patients has been implemented at many dialysis facilities in Japan. However, reports comparing the effects on body function of electric and variable-load ergometers are few. This study aimed to compare electric ergometers and variable-load ergometers in terms of exercise outcomes in HD patients.
Methods


A total of 15 ambulatory HD patients were randomly divided into two groups: the variable-load ergometer group (n=8) and the electric ergometer group (n=7). HD patients exercised at a level based on their physical function three times a week for 12 weeks.
Results


After the 12-week intervention period, only the variable-load ergometer group experienced significant increases in lower extremity muscle strength and exercise tolerance.
Conclusion


This study confirmed that conventional aerobic training and electric bike exercise during HD were efficacious and safe without causing sudden hypotension or any other side effects. However, exercise using a variable-load ergometer may be more effective than exercise using an electric bike in improving the physical function of HD patients. Exercise using a variable-load ergometer elicited specific whole-body and local effects.",2017,"After the 12-week intervention period, only the variable-load ergometer group experienced significant increases in lower extremity muscle strength and exercise tolerance.
","['HD patients', '15 ambulatory HD patients', 'Patients with End-stage Renal Disease']","['electric ergometer group', 'conventional aerobic training and electric bike exercise', 'variable-load ergometer group', 'Aerobic and resistance exercises', 'Training with an Electric Exercise Bike versus a Conventional Exercise Bike during Hemodialysis']","['lower extremity muscle strength and exercise tolerance', 'maximal oxygen uptake and muscle strength']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0392218', 'cui_str': 'Bicycle exerciser'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",15.0,0.0131777,"After the 12-week intervention period, only the variable-load ergometer group experienced significant increases in lower extremity muscle strength and exercise tolerance.
","[{'ForeName': 'Misa', 'Initials': 'M', 'LastName': 'Miura', 'Affiliation': 'Tsukuba University of Technology, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Yoshizawa', 'Affiliation': 'Asao Clinic, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Oowada', 'Affiliation': 'Asao Clinic, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Aki', 'Initials': 'A', 'LastName': 'Hirayama', 'Affiliation': 'Tsukuba University of Technology, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Ito', 'Affiliation': 'Northeast Medical Pharmaceutical University, Sendai, Miyagi, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Kohzuki', 'Affiliation': 'Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': 'Teruhiko', 'Initials': 'T', 'LastName': 'Maeba', 'Affiliation': 'Asao Clinic, Kawasaki, Kanagawa, Japan.'}]",Progress in rehabilitation medicine,['10.2490/prm.20170008']
2247,32789241,Safety and Feasibility of Dual-task Rehabilitation Program for Body Trunk Balance Using Virtual Reality and Three-dimensional Tracking Technologies.,"Objective


The ability to walk is one of the most important basic functional activities of daily living, and the number of patients with walking disability who need rehabilitation is increasing worldwide. The purpose of this first-in-man study was to evaluate the safety and feasibility of an off-label, tailor-made, dual-task rehabilitation program for body trunk balance using the mediVR01 system (mediVR, Inc. Osaka, Japan), which incorporates virtual reality (VR) and three-dimensional tracking technologies.
Methods


We prospectively enrolled 31 healthy volunteers to take part in the trial (Trial Registration UMIN000029659). After an assessment of body trunk balance, a tailor-made, dual-task, rehabilitation training program lasting 10-15 min was provided. The primary endpoint was the postprocedural number of simulator sickness questionnaire (SSQ) symptoms. The secondary endpoints were adverse events and satisfaction with the program.
Results


The median age of participants was 68 years, with 67.7% being elderly (>65 years) and 54.8% being male. The number of SSQ symptoms immediately after the rehabilitation programs significantly increased from 0 (interquartile range 0-0) to 0 (0-1.5) (P=0.009), with a significant difference between the young and elderly participants (P-interaction<0.001). The most frequent symptom was sweating (22.6%), followed by fatigue (19.4%). All participants successfully completed the rehabilitation programs without significant adverse events such as fall or injuries. Moreover, all participants considered the VR rehabilitation programs to be enjoyable, and 93.5% of participants reported a sense of achievement. Group attendance was associated with higher levels of satisfaction (P=0.049).
Conclusion


The tailor-made, dual-task rehabilitation training programs for body trunk balance using VR and three-dimensional tracking technologies were safe and feasible even for elderly participants.",2018,"Group attendance was associated with higher levels of satisfaction (P=0.049).
","['31 healthy volunteers', 'elderly participants', 'The median age of participants was 68 years, with 67.7% being elderly (>65 years) and 54.8% being male']","['Dual-task Rehabilitation Program', 'label, tailor-made, dual-task rehabilitation program']","['postprocedural number of simulator sickness questionnaire (SSQ) symptoms', 'number of SSQ symptoms', 'adverse events such as fall or injuries', 'levels of satisfaction', 'adverse events and satisfaction with the program']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",31.0,0.0232883,"Group attendance was associated with higher levels of satisfaction (P=0.049).
","[{'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Hara', 'Affiliation': 'Center for Community-based Healthcare Research and Education, Shimane University, Izumo, Japan.'}, {'ForeName': 'Tetsuhisa', 'Initials': 'T', 'LastName': 'Kitamura', 'Affiliation': 'Division of Environmental Medicine and Population Sciences, Department of Social and Environmental Medicine, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Murakawa', 'Affiliation': 'Division of Stroke Rehabilitation, National Cerebral and Cardiovascular Center Hospital, Suita, Japan.'}, {'ForeName': 'Kyosuke', 'Initials': 'K', 'LastName': 'Shimba', 'Affiliation': 'Department of Medical Device Development, mediVR, Inc., Osaka, Japan.'}, {'ForeName': 'Shimpei', 'Initials': 'S', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Medical Device Development, mediVR, Inc., Osaka, Japan.'}, {'ForeName': 'Masatake', 'Initials': 'M', 'LastName': 'Tamaki', 'Affiliation': 'Department of Medical Device Development, mediVR, Inc., Osaka, Japan.'}]",Progress in rehabilitation medicine,['10.2490/prm.20180016']
2248,32789251,Effect of the Management Tool for Daily Life Performance on Patients with Cardiovascular Disease: A Randomized Controlled Trial.,"Objective


Cardiovascular diseases cause psychological symptoms, such as depression and anxiety. Symptoms of depression have a major effect on patients and worsen prognosis as a result of reduced quality of life and decreased levels of physical activity. Because cardiac rehabilitation (CR) has physical, mental, and secondary preventative effects, it is necessary to evaluate the psychological factors of patients and to provide patients with psychological support based on the results. The management tool for daily life performance (MTDLP) was developed in 2006 by the Japanese Association of Occupational Therapists. Since then, its effectiveness for patients with cerebrovascular diseases and bone fractures has been verified. However, no randomized controlled trial has been conducted on the effectiveness of interventions using MTDLP on patients with cardiovascular diseases.
Methods


We examined the effectiveness of intervention using MTDLP on patients undergoing outpatient CR. Thirty-six patients who scored at least 48 on the self-rating depression scale (SDS) were included in the study. Eighteen patients were allocated to both the CR and MTDLP groups. The SDS, Barthel index, Frenchay Activities Index (FAI), and Life-Space Assessment were evaluated as outcome measures.
Results


The CR group (n=14) showed significantly improved post-intervention scores on the SDS (P=0.007). Furthermore, the MTDLP group (n=11) showed significantly improved post-intervention scores on the SDS (P=0.010) and FAI (P=0.003).
Conclusions


CR improves depression, whereas additional intervention using MTDLP improves not only depression but also various daily activities. Consequently, intervention using MTDLP in CR appears to be effective.",2019,The CR group (n=14) showed significantly improved post-intervention scores on the SDS (P=0.007).,"['patients with cerebrovascular diseases and bone fractures', 'patients undergoing outpatient CR', 'Eighteen patients', '2006 by the Japanese Association of Occupational Therapists', 'Patients with Cardiovascular Disease', 'patients with cardiovascular diseases', 'Thirty-six patients who scored at least 48 on the self-rating depression scale (SDS) were included in the study']",['MTDLP'],"['SDS, Barthel index, Frenchay Activities Index (FAI), and Life-Space Assessment', 'post-intervention scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007820', 'cui_str': 'Cerebrovascular disease'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",18.0,0.0387807,The CR group (n=14) showed significantly improved post-intervention scores on the SDS (P=0.007).,"[{'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Fukui', 'Affiliation': 'Department of Rehabilitation, Nara Prefectural Seiwa Medical Center, Nara, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Yoshida', 'Affiliation': 'Department of Rehabilitation, Nara Prefectural Seiwa Medical Center, Nara, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Higaki', 'Affiliation': 'Department of Community Health, Osaka Prefectural University, Osaka, Japan.'}]",Progress in rehabilitation medicine,['10.2490/prm.20190004']
2249,32789276,Preventive Effects of Repetitive Peripheral Magnetic Stimulation on Muscle Atrophy in the Paretic Lower Limb of Acute Stroke Patients: A Pilot Study.,"Objective


The aim of this study was to investigate the effect of repetitive peripheral magnetic stimulation (rPMS) on muscle atrophy prevention in the rectus femoris muscle (RF) of the paretic limb in acute stroke patients.
Methods


Twelve acute stroke patients with a National Institute of Health Stroke Scale score >5 and a motor score of the paretic lower limb >2 at admission were divided into an intervention group (rPMS: mean age, 75±6.4 years) and a conventional care group (non-rPMS: mean age, 62±11.8 years). Baseline measurements were performed within 4 days of stroke onset. In the rPMS group, treatment was applied to the paretic thigh only for 2 weeks, 5 days a week, in addition to conventional care. The cross-sectional area (CSA) of the RF was assessed in both limbs using ultrasound at baseline and 2 weeks later. Data on patient characteristics were collected from the clinical records to assess correlations with the CSA rate of change.
Results


Patients in the rPMS group were significantly older. Although the CSA of the RF did not change significantly on either side in the rPMS group, there was a significant decrease in the CSA on the paretic side in the non-rPMS group. However, no significant difference was observed in the CSA rate of change in the rPMS and non-rPMS groups. The CSA rate of change on the paretic side correlated negatively with age in the rPMS group.
Conclusions


Our results suggest that rPMS prevents muscle atrophy more effectively in patients in their 60s than in patients more than 70 years old.",2020,"However, no significant difference was observed in the CSA rate of change in the rPMS and non-rPMS groups.","['Acute Stroke Patients', 'acute stroke patients', 'Twelve acute stroke patients with a National Institute of Health Stroke Scale score >5 and a motor score of the paretic lower limb >2 at admission were divided into an intervention group (rPMS: mean age, 75±6.4 years) and a conventional care group (non-rPMS: mean age, 62±11.8 years']","['repetitive peripheral magnetic stimulation (rPMS', 'Repetitive Peripheral Magnetic Stimulation', 'rPMS']","['CSA rate', 'CSA rate of change', 'CSA rate of change on the paretic side']","[{'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0249341,"However, no significant difference was observed in the CSA rate of change in the rPMS and non-rPMS groups.","[{'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Department of Public Health, Graduate School of Advanced Preventive Medical Sciences, Kanazawa University, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Tomotaka', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Department of Rehabilitation, Faculty of Health Science and Technology, Kawasaki University of Medical Welfare, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'Rehabilitation Center, Kawasaki Medical School Hospital, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Hiraoka', 'Affiliation': 'Department of Rehabilitation, Faculty of Health Science and Technology, Kawasaki University of Medical Welfare, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Kozo', 'Initials': 'K', 'LastName': 'Hanayama', 'Affiliation': 'Department of Rehabilitation Medicine, Kawasaki Medical School, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Tsubahara', 'Affiliation': 'Department of Rehabilitation, Faculty of Health Science and Technology, Kawasaki University of Medical Welfare, Kurashiki, Okayama, Japan.'}]",Progress in rehabilitation medicine,['10.2490/prm.20200008']
2250,32789516,Effect of D-Cycloserine on the Effect of Concentrated Exposure and Response Prevention in Difficult-to-Treat Obsessive-Compulsive Disorder: A Randomized Clinical Trial.,"Importance


Evidence is lacking for viable treatment options for patients with difficult-to-treat obsessive-compulsive disorder (OCD). It has been suggested that D-cycloserine (DCS) could potentiate the effect of exposure and response prevention (ERP) treatment, but the hypothesis has not been tested among patients with difficult-to-treat OCD.
Objective


To evaluate whether DCS potentiates the effect of concentrated ERP among patients with difficult-to-treat OCD.
Design, Setting, and Participants


The study was a randomized placebo-controlled triple-masked study with a 12-month follow-up. Participants were adult outpatients with difficult-to-treat OCD. A total of 220 potential participants were referred, of whom 36 did not meet inclusion criteria and 21 declined to participate. Patients had either relapsed after (n = 100) or not responded to (n = 63) previous ERP treatment. A total of 9 specialized OCD teams within the public health care system in Norway participated, giving national coverage. An expert team of therapists from the coordinating site delivered treatment. Inclusion of patients started in January 2016 and ended in August 2017. Data analysis was conducted February to September 2019.
Interventions


All patients received individual, concentrated ERP treatment delivered during 4 consecutive days in a group setting (the Bergen 4-day treatment format) combined with 100 mg DCS, 250 mg DCS, or placebo.
Main outcomes and Measures


Change in symptoms of OCD and change in diagnostic status. Secondary outcomes measures included self-reported symptoms of OCD, anxiety, depression, and quality of life.
Results


The total sample of 163 patients had a mean (SD) age of 34.5 (10.9) years, and most were women (117 [71.8%]). They had experienced OCD for a mean (SD) of 16.2 (10.2) years. A total of 65 patients (39.9%) were randomized to receive 100 mg DCS, 67 (41.1%) to 250 mg of DCS, and 31 (19.0%) to placebo. Overall, 91 (56.5%) achieved remission at posttreatment, while 70 (47.9%) did so at the 12-month follow-up. There was no significant difference in remission rates among groups. There was a significant reduction in symptoms at 12 months, and within-group effect sizes ranged from 3.01 (95% CI, 2.38-3.63) for the group receiving 250 mg DCS to 3.49 (95% CI, 2.78-4.18) for the group receiving 100 mg DCS (all P < .001). However, there was no significant effect of treatment group compared with placebo in obsessive-compulsive symptoms (250 mg group at posttreatment: d = 0.33; 95% CI, -0.10 to 0.76; 100 mg group at posttreatment: d = 0.36; 95% CI, -0.08 to 0.79), symptoms of depression and anxiety (eg, Patient Health Questionnaire-9 score among 250 mg group at 12-month follow-up: d = 0.30; 95% CI, -0.17 to 0.76; Generalized Anxiety Disorder-7 score among 100 mg group at 12-month follow-up: d = 0.27; 95% CI, -0.19 to 0.73), and well-being (250 mg group: d = 0.10; 95% CI, -0.42 to 0.63; 100 mg group: d = 0.34; 95% CI, -0.19 to 0.86). No serious adverse effects were reported.
Conclusions and Relevance


In this study, DCS did not potentiate ERP treatment effect, but concentrated ERP treatment was associated with improvement.
Trial Registration


ClinicalTrials.gov identifier: NCT02656342.",2020,"There was a significant reduction in symptoms at 12 months, and within-group effect sizes ranged from 3.01 (95% CI, 2.38-3.63) for the group receiving 250 mg DCS to 3.49 (95% CI, 2.78-4.18) for the group receiving 100 mg DCS (all P < .001).","['patients with difficult-to-treat obsessive-compulsive disorder (OCD', 'A total of 9 specialized OCD teams within the public health care system in Norway participated, giving national coverage', '163 patients had a mean (SD) age of 34.5 (10.9) years, and most were women (117 [71.8', 'A total of 65 patients (39.9', 'Patients had either relapsed after (n\u2009=\u2009100) or not responded to (n\u2009=\u200963) previous ERP treatment', 'patients with difficult-to-treat OCD', 'Difficult-to-Treat Obsessive-Compulsive Disorder', 'A total of 220 potential participants were referred, of whom 36 did not meet inclusion criteria and 21 declined to participate', 'Participants were adult outpatients with difficult-to-treat OCD']","['D-cycloserine (DCS', 'D-Cycloserine', 'Concentrated Exposure and Response Prevention', 'DCS', 'DCS, 250 mg DCS, or placebo', 'placebo']","['symptoms of depression and anxiety (eg, Patient Health Questionnaire-9 score', 'self-reported symptoms of OCD, anxiety, depression, and quality of life', 'obsessive-compulsive symptoms', 'remission rates', 'symptoms', 'symptoms of OCD and change in diagnostic status', 'Generalized Anxiety Disorder-7 score', 'remission', 'serious adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4087290', 'cui_str': 'Obsessive-compulsive symptom'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",220.0,0.476199,"There was a significant reduction in symptoms at 12 months, and within-group effect sizes ranged from 3.01 (95% CI, 2.38-3.63) for the group receiving 250 mg DCS to 3.49 (95% CI, 2.78-4.18) for the group receiving 100 mg DCS (all P < .001).","[{'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Kvale', 'Affiliation': 'Bergen Center for Brain Plasticity, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Bjarne', 'Initials': 'B', 'LastName': 'Hansen', 'Affiliation': 'Bergen Center for Brain Plasticity, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Hagen', 'Affiliation': 'Bergen Center for Brain Plasticity, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Abramowitz', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina, Chapel Hill.'}, {'ForeName': 'Tore', 'Initials': 'T', 'LastName': 'Børtveit', 'Affiliation': 'Bergen Center for Brain Plasticity, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Department of Psychology, University of California, Los Angeles.'}, {'ForeName': 'Martin E', 'Initials': 'ME', 'LastName': 'Franklin', 'Affiliation': 'Rogers Memorial Hospital, Oconomowoc, Wisconsin.'}, {'ForeName': 'Svein', 'Initials': 'S', 'LastName': 'Haseth', 'Affiliation': 'Nidaros Outpatient Psychiatric Unit, St. Olavs Hospital, Trondheim, Norway.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Himle', 'Affiliation': 'School of Social Work, Department of Psychiatry, University of Michigan, Ann Arbor.'}, {'ForeName': 'Sigurd', 'Initials': 'S', 'LastName': 'Hystad', 'Affiliation': 'Department for Psychosocial Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Unn Beate', 'Initials': 'UB', 'LastName': 'Kristensen', 'Affiliation': 'Gaustad Hospital, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Gunvor', 'Initials': 'G', 'LastName': 'Launes', 'Affiliation': 'Solvang Outpatient Psychiatric Unit, Sørlandet Hospital, Kristiansand, Norway.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Lund', 'Affiliation': 'Division of Psychiatry, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Stian', 'Initials': 'S', 'LastName': 'Solem', 'Affiliation': 'Bergen Center for Brain Plasticity, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Lars-Göran', 'Initials': 'LG', 'LastName': 'Öst', 'Affiliation': 'Bergen Center for Brain Plasticity, Haukeland University Hospital, Bergen, Norway.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.13249']
2251,32789528,Effects of short-term continuous Montmorency tart cherry juice supplementation in participants with metabolic syndrome.,"PURPOSE


Metabolic Syndrome (MetS) augments the incidence of cardiovascular disease by two-fold and type II diabetes mellitus by five-fold. Montmorency tart cherries are rich in phytochemicals shown to improve biomarkers related to cardio-metabolic health in humans. This study aimed to examine cardio-metabolic responses after 7-days Montmorency tart cherry juice (MTCJ) supplementation and also acute on short-term supplementation responses to a single bolus, in humans with MetS.
METHODS


In a randomised, single-blind, placebo-controlled, crossover trial, 12 participants with MetS (50 ± 10 years; 6M/6F), consumed MTCJ or placebo (PLA) for 7 days. Blood-based and functional cardio-metabolic biomarkers were measured pre- and post-supplementation, and acute responses measured pre-bolus and up to 5 h post-bolus on the 7th day.
RESULTS


24-h ambulatory systolic (P = 0.016), diastolic (P = 0.009) blood pressure and mean arterial pressure (P = 0.041) were significantly lower after 7-days MTCJ supplementation compared to PLA. Glucose (P = 0.038), total cholesterol (P = 0.036), LDL (P = 0.023) concentrations, total cholesterol:HDL ratio (P = 0.004) and respiratory exchange ratio values (P = 0.009) were significantly lower after 6-days MTCJ consumption compared to PLA.
CONCLUSIONS


This study revealed for the first time in humans that MTCJ significantly improved 24-h BP, fasting glucose, total cholesterol and total cholesterol:HDL ratio, and also lowered resting respiratory exchange ratio compared to a control group. Responses demonstrated clinically relevant improvements on aspects of cardio-metabolic function, emphasising the potential efficacy of MTCJ in preventing further cardio-metabolic dysregulation in participants with MetS. Registered at clinicaltrials.gov (NCT03619941).",2020,", diastolic (P = 0.009) blood pressure and mean arterial pressure (P = 0.041) were significantly lower after 7-days MTCJ supplementation compared to PLA.","['12 participants with MetS (50\u2009±\u200910\xa0years; 6M/6F', 'participants with metabolic syndrome', 'humans with MetS']","['consumed MTCJ or placebo (PLA', 'short-term continuous Montmorency tart cherry juice supplementation', 'MTCJ', '7-days Montmorency tart cherry juice (MTCJ) supplementation', 'placebo']","['24-h BP, fasting glucose, total cholesterol and total cholesterol:HDL ratio', 'Glucose', 'Blood-based and functional cardio-metabolic biomarkers', 'total cholesterol', '24-h ambulatory systolic', 'blood pressure and mean arterial pressure', 'respiratory exchange ratio values', 'LDL', 'total cholesterol:HDL ratio']","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0982074', 'cui_str': 'CHERRY JUICE'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C2938855', 'cui_str': 'Total cholesterol:HDL ratio measurement'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]",12.0,0.0518401,", diastolic (P = 0.009) blood pressure and mean arterial pressure (P = 0.041) were significantly lower after 7-days MTCJ supplementation compared to PLA.","[{'ForeName': 'Terun', 'Initials': 'T', 'LastName': 'Desai', 'Affiliation': 'Department of Psychology and Sports Science, School of Life and Medical Sciences, University of Hertfordshire, College Lane, Hatfield, AL10 9AB, UK. t.desai@herts.ac.uk.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roberts', 'Affiliation': 'Department of Psychology and Sports Science, School of Life and Medical Sciences, University of Hertfordshire, College Lane, Hatfield, AL10 9AB, UK.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Bottoms', 'Affiliation': 'Department of Psychology and Sports Science, School of Life and Medical Sciences, University of Hertfordshire, College Lane, Hatfield, AL10 9AB, UK.'}]",European journal of nutrition,['10.1007/s00394-020-02355-5']
2252,32789530,Bag-of-features-based radiomics for differentiation of ocular adnexal lymphoma and idiopathic orbital inflammation from contrast-enhanced MRI.,"OBJECTIVES


To evaluate the effectiveness of bag-of-features (BOF)-based radiomics for differentiating ocular adnexal lymphoma (OAL) and idiopathic orbital inflammation (IOI) from contrast-enhanced MRI (CE-MRI).
METHODS


Fifty-six patients with pathologically confirmed IOI (28 patients) and OAL (28 patients) were randomly divided into training (n = 42) and testing (n = 14) groups. One hundred sixty texture features extracted from the CE-MR image were encoded into the BOF representation with fewer features. The support vector machine (SVM) with a linear kernel was used as the classifier. Data augmented was performed by cropping orbital lesions in different directions to alleviate the over-fitting problem. Student's t test and the Holm-Bonferroni method were employed to compare the performance of different analysis methods. The chi-square test was used to compare the analysis with MRI and human radiological diagnosis.
RESULTS


In the independent testing group, the differentiation by the BOF features with augmentation achieved an area under the curve (AUC) of 0.803 (95% CI: 0.725-0.880), which was significantly higher than that of the BOF features without augmentation and that of the texture features (p < 0.05). In addition, the same radiomic analysis with pre-contrast MRI obtained an AUC of 0.618 (95% CI: 0.560-0.677), which was significantly lower than that with CE-MRI. The diagnostic performance of the analysis with CE-MRI was significantly better than the radiology resident (p < 0.05) but had no significant difference with the experienced radiologist, even though there was less consistency between the radiomic analysis and the human visual diagnosis.
CONCLUSIONS


The BOF-based radiomics may be helpful for the differentiation between OAL and IOI.
KEY POINTS


• It is challenging to differentiate OAL from IOI due to the similar clinical and image features. • Radiomics has great potential for the noninvasive diagnosis of orbital diseases. • The BOF representation from patch to image may help the differentiation of OAL and IOI.",2020,"The diagnostic performance of the analysis with CE-MRI was significantly better than the radiology resident (p < 0.05) but had no significant difference with the experienced radiologist, even though there was less consistency between the radiomic analysis and the human visual diagnosis.
",['Fifty-six patients with pathologically confirmed IOI (28 patients) and OAL (28 patients'],['bag-of-features (BOF)-based radiomics'],['BOF features with augmentation achieved an area under the curve (AUC'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0085270', 'cui_str': 'Inflammatory pseudotumor of orbit'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}]","[{'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",56.0,0.0345749,"The diagnostic performance of the analysis with CE-MRI was significantly better than the radiology resident (p < 0.05) but had no significant difference with the experienced radiologist, even though there was less consistency between the radiomic analysis and the human visual diagnosis.
","[{'ForeName': 'Yuqing', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': ""School of Information Science and Technology, Northwest University, Xi'an, 710069, Shaanxi, China.""}, {'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': ""School of Information Science and Technology, Northwest University, Xi'an, 710069, Shaanxi, China.""}, {'ForeName': 'Jixin', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""School of Information Science and Technology, Northwest University, Xi'an, 710069, Shaanxi, China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Lv', 'Affiliation': ""Department of Radiology, Xi'an Fourth Hospital, Xi'an, 710004, Shaanxi, China.""}, {'ForeName': 'Shijie', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': ""Department of Radiology, Xi'an Fourth Hospital, Xi'an, 710004, Shaanxi, China.""}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'He', 'Affiliation': ""School of Information Science and Technology, Northwest University, Xi'an, 710069, Shaanxi, China.""}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Department of Radiology, Xi'an Fourth Hospital, Xi'an, 710004, Shaanxi, China. ylijuan@126.com.""}, {'ForeName': 'Fengjun', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': ""School of Information Science and Technology, Northwest University, Xi'an, 710069, Shaanxi, China. fjzhao@nwu.edu.cn.""}]",European radiology,['10.1007/s00330-020-07110-2']
2253,32789625,"Awareness, Willingness, and Perceived Efficacy of Pre-exposure Prophylaxis among Adolescent Sexual Minority Males.","Despite the approval of PrEP for adolescents by the FDA in 2018, little is known about the awareness and attitudes about PrEP use among adolescent sexual minority males, who are at the greatest risk for HIV. We analyzed baseline data from the MyPEEPS Mobile study, a multi-site randomized controlled trial evaluating the effectiveness of a mobile behavioral HIV prevention intervention. A substantial proportion (68.2%) of study participants (ages 13-18) had previously heard about PrEP, and an overwhelming majority (90.8%) reported willingness to take PrEP, to prevent HIV. On the other hand, only about one third (34.6%) of participants indicated that taking a daily HIV pill would be ""very"" or ""completely"" effective in preventing HIV when having sex without a condom. These findings suggest that high awareness and willingness to use PrEP across various adolescent subgroups present opportunities for increased PrEP advocacy among this young age group.",2020,"A substantial proportion (68.2%) of study participants (ages 13-18) had previously heard about PrEP, and an overwhelming majority (90.8%) reported willingness to take PrEP, to prevent HIV.","['adolescent sexual minority males', 'Adolescent Sexual Minority Males']",['mobile behavioral HIV prevention intervention'],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4277573', 'cui_str': 'Lesbigay Persons'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0544438,"A substantial proportion (68.2%) of study participants (ages 13-18) had previously heard about PrEP, and an overwhelming majority (90.8%) reported willingness to take PrEP, to prevent HIV.","[{'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Gordián-Arroyo', 'Affiliation': 'Columbia University, Mailman School of Public Health, New York, NY, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Garofalo', 'Affiliation': ""Department of Pediatrics, Northwestern's Feinberg School of Medicine, Chicago, IL, USA.""}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Kuhns', 'Affiliation': ""Department of Pediatrics, Northwestern's Feinberg School of Medicine, Chicago, IL, USA.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Pearson', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Bruce', 'Affiliation': 'Birmingham AIDS Outreach, Birmingham, AL, USA.'}, {'ForeName': 'D Scott', 'Initials': 'DS', 'LastName': 'Batey', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Asa', 'Initials': 'A', 'LastName': 'Radix', 'Affiliation': 'Callen-Lorde Community Health Center, New York, NY, USA.'}, {'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Belkind', 'Affiliation': 'Callen-Lorde Community Health Center, New York, NY, USA.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Hidalgo', 'Affiliation': ""Keck School of Medicine of the University of Southern California/Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Hirshfield', 'Affiliation': 'SUNY Downstate Health Sciences University, Department of Medicine, Brooklyn, NY, USA.'}, {'ForeName': 'Eric W', 'Initials': 'EW', 'LastName': 'Schrimshaw', 'Affiliation': 'University of Central Florida, College of Medicine, Orlando, FL, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Schnall', 'Affiliation': 'Columbia University, School of Nursing, New York, NY, USA. rb897@columbia.edu.'}]",Journal of urban health : bulletin of the New York Academy of Medicine,['10.1007/s11524-020-00447-5']
2254,32789656,OCT evaluation of orthodontic surface sealants: a 12-month follow-up randomized clinical trial.,"OBJECTIVES


The aim of this single-center randomized controlled trial (NCT03753256) was to assess orthodontic surface sealant layer thickness and integrity in vivo during a 12-month follow-up by optical coherence tomography (OCT).
MATERIALS AND METHODS


Using a split-mouth design, quadrants of 20 patients treated with fixed orthodontic appliances were included. Quadrants were randomly assigned to the sealants Pro Seal® (PS) or Opal® Seal™ (OS). OCT scans were performed immediately after the application of the sealants and after 3, 6, 9, and 12 months. Sealant layer thicknesses and their integrity were determined at 5 regions of interest (ROIs) known for high risks of demineralization. Sealant integrity loss was determined using a self-developed scale.
RESULTS


A total of 16 patients successfully completed the study. The studied sealants showed significant differences in initial layer thickness. Mean layer thickness was significantly lower for PS (67.8 μm, (95% CI, 56.1-79.5)) than for OS (110.7 μm, (95% CI, 97.3-124.1)). Layer thickness loss was significant after 3 months for PS and after 6 months for OS. Sealant integrity was compromised in more than 50% of the ROIs already after 3 months for both sealants.
CONCLUSIONS


Patients treated with fixed orthodontic surface sealants lost the integrity of the protective layer in more than 50% of cases after 3 months, and the layer thickness of the sealants was significantly reduced after 3-6 months.
CLINICAL RELEVANCE


The protective effect against demineralization lesions of orthodontic sealants in patients treated with fixed appliances appears to be limited in time. Further preventive measures should be investigated.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT03753256).",2020,Quadrants were randomly assigned to the sealants Pro Seal® (PS) or Opal® Seal™ (OS).,"['patients treated with fixed appliances', '16 patients successfully completed the study', '20 patients treated with fixed orthodontic appliances were included']","['orthodontic surface sealants', 'sealants Pro Seal® (PS) or Opal® Seal™ (OS']","['Layer thickness loss', 'initial layer thickness', 'OCT scans', 'Mean layer thickness', 'layer thickness of the sealants', 'Sealant integrity loss', 'integrity of the protective layer', 'Sealant integrity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C1570472', 'cui_str': 'Pro Seal'}, {'cui': 'C0084990', 'cui_str': 'VPDA protocol'}, {'cui': 'C0036492', 'cui_str': 'Seal'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0205266', 'cui_str': 'Intact'}]",16.0,0.185348,Quadrants were randomly assigned to the sealants Pro Seal® (PS) or Opal® Seal™ (OS).,"[{'ForeName': 'Sinan', 'Initials': 'S', 'LastName': 'Şen', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany. sinan.sen@med.uni-heidelberg.de.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Erber', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Gül', 'Initials': 'G', 'LastName': 'Orhan', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Zingler', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lux', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}]",Clinical oral investigations,['10.1007/s00784-020-03462-7']
2255,32790002,Who is a credible source of preventive advice? An experimental vignette study of general public attitudes towards role expansion in health and social care.,"OBJECTIVES


To investigate the general public's source credibility attitudes towards health and social care professionals when giving advice associated with their 'traditional role' versus an 'expanded health behaviour change' role, to facilitate the implementation of the health behaviour change agenda.
DESIGN


A 3x3 experimental between-subjects vignette questionnaire study with nine scenarios in which a general practitioner (GP), health visitor, or firefighter offered advice on either stopping smoking, preventing cot death, or fire safety. Combinations were either congruent with a traditional role (e.g., health visitor and cot death) or an expanded role (e.g., firefighter and stopping smoking).
METHODS


Adults were recruited from metropolitan locations in northern England. Participants were randomized to one scenario and complete a validated 18-item source credibility questionnaire. Factor analysis explored source credibility components; ratings for traditional and expanded role scenarios were compared using Mann-Whitney tests.
RESULTS


369 participants completed the questionnaire (49.3% women, 64% White British, age range: 16-83). Factor analysis confirmed three source credibility dimensions: competence, caring, and trustworthiness. Ratings were generally high across professions and scenarios; participants rated professionals as significantly more 'competent' where scenarios related to their traditional roles than expanded roles (U  9778.5, p  <.001) but equally as caring (U = 14467.5, p< .485) and trustworthy (U  14250.5, p  .348).
CONCLUSIONS


GPs, health visitors, and firefighters were all perceived as credible sources of health behaviour change advice, but may be viewed as 'less competent' sources of messages associated with an expanded job role. Effective professional training and public engagement regarding the role expansion agenda are needed to support policy implementation. Statement of Contribution What is already known on this subject? Source credibility surrounds people's perceptions of the source of advice and includes competence, caring, and trustworthiness dimensions. This may have an important influence on people's attitudes and behaviour, especially when messages are complex or emotive. A wide range of public sector workers is now expected to routinely offer preventive health and safety advice, as part of role expansion. What does this study add? This experimental survey study compared source credibility perceptions of GPs, health visitors, and firefighters giving advice on topics associated with a traditional or expanded role. Professionals were perceived as less 'competent' when giving advice on 'expanded role' topics, such as a firefighter discussing smoking, with a small reduction in source credibility. This highlights that source credibility may be specific to professional identities. Policymakers may need to explore this further as part of implementing role expansion for prevention and self-management in health and social care.",2020,"Professionals were perceived as less 'competent' when giving advice on 'expanded role' topics, such as a firefighter discussing smoking, with a small reduction in source credibility.","['A 3x3 experimental between-subjects vignette questionnaire study with nine scenarios in which a general practitioner (GP), health visitor, or firefighter offered advice on either stopping smoking, preventing cot death, or fire safety', 'public sector workers', 'general public attitudes towards role expansion in health and social care', '369 participants completed the questionnaire (49.3% women, 64% White British, age range: 16-83', 'Adults were recruited from metropolitan locations in northern England']",[],[],"[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0018765', 'cui_str': 'Health Visitors'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0038644', 'cui_str': 'Sudden infant death syndrome'}, {'cui': 'C0014007', 'cui_str': 'Dismissed from job'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034035', 'cui_str': 'Public Sector'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0419189', 'cui_str': 'Social care'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1278523', 'cui_str': 'White British'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0014282', 'cui_str': 'England'}]",[],[],369.0,0.0242956,"Professionals were perceived as less 'competent' when giving advice on 'expanded role' topics, such as a firefighter discussing smoking, with a small reduction in source credibility.","[{'ForeName': 'Eleanor R', 'Initials': 'ER', 'LastName': 'Bull', 'Affiliation': 'Centre for Applied Psychology and Behaviour Change, Manchester Metropolitan University, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Mills', 'Affiliation': 'School of Health Sciences, University of Manchester, UK.'}, {'ForeName': 'Lucie M T', 'Initials': 'LMT', 'LastName': 'Byrne-Davis', 'Affiliation': 'Division of Medical Education, University of Manchester, UK.'}, {'ForeName': 'Jo K', 'Initials': 'JK', 'LastName': 'Hart', 'Affiliation': 'Division of Medical Education, University of Manchester, UK.'}]",British journal of health psychology,['10.1111/bjhp.12464']
2256,32790020,The role of comorbid anxiety in exercise and depression trials: Secondary analysis of the SMILE-II randomized clinical trial.,"OBJECTIVES


To explore the anxiolytic effects of a 4-month randomized, placebo-controlled trial of exercise and antidepressant medication in patients with major depressive disorder (MDD), and to examine the potential modifying effects of anxiety in treating depressive symptoms.
MATERIALS AND METHODS


In this secondary analysis of the SMILE-II trial, 148 sedentary adults with MDD were randomized to: (a) supervised exercise, (b) home-based exercise, (c) sertraline, or (d) placebo control. Symptoms of state anxiety measured by the Spielberger Anxiety Inventory were examined before and after 4 months of treatment. Depressive symptoms were assessed by the Hamilton Depression Rating Scale (HAMD) and Beck Depression Inventory-II (BDI-II). Analyses were carried out using general linear models.
RESULTS


Compared to placebo controls, the exercise and sertraline groups had lower state anxiety scores (standardized difference = 0.3 [95% CI = -0.6, -0.04]; p = 0.02) after treatment. Higher pretreatment state anxiety was associated with poorer depression outcomes in the active treatments compared to placebo controls for both the HAMD (p = .004) and BDI-II (p = .02).
CONCLUSION


Aerobic exercise as well as sertraline reduced symptoms of state anxiety in patients with MDD. Higher levels of pretreatment anxiety attenuated the effects of the interventions on depressive symptoms, however, especially among exercisers. Patients with MDD with higher comorbid state anxiety appear to be less likely to benefit from exercise interventions in reducing depression and thus may require supplemental treatment with special attention to anxiety.",2020,"Higher pretreatment state anxiety was associated with poorer depression outcomes in the active treatments compared to placebo controls for both the HAMD (p = .004) and BDI-II (p = .02).
","['148 sedentary adults with MDD', 'Patients with MDD with higher comorbid state anxiety', 'patients with major depressive disorder (MDD', 'patients with MDD']","['exercise interventions', 'exercise and antidepressant medication', 'Aerobic exercise', 'supervised exercise, (b) home-based exercise, (c) sertraline, or (d) placebo control', 'placebo']","['Spielberger Anxiety Inventory', 'state anxiety scores', 'poorer depression outcomes', 'depressive symptoms', 'Depressive symptoms', 'Hamilton Depression Rating Scale (HAMD) and Beck Depression Inventory-II (BDI-II', 'anxiolytic effects', 'Symptoms of state anxiety', 'state anxiety']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C3179404', 'cui_str': 'Anti-Anxiety Effects'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",148.0,0.239553,"Higher pretreatment state anxiety was associated with poorer depression outcomes in the active treatments compared to placebo controls for both the HAMD (p = .004) and BDI-II (p = .02).
","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Blumenthal', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Babyak', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Wade Edward', 'Initials': 'WE', 'LastName': 'Craighead', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Davidson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Hinderliter', 'Affiliation': 'Department of Medicine, School of Medicine, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Benson', 'Initials': 'B', 'LastName': 'Hoffman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Pudugramam Murali', 'Initials': 'PM', 'LastName': 'Doraiswamy', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Sherwood', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.'}]",Depression and anxiety,['10.1002/da.23088']
2257,32782904,An Injury Prevention Program for Professional Ballet: A Randomized Controlled Investigation.,"Background


Few investigations have examined dance-specific injury prevention programs (IPPs), and no published randomized controlled trials are available that evaluate IPPs for dance.
Hypothesis


The implementation of an IPP will significantly reduce the risk of injury in professional ballet dancers.
Study Design


Randomized controlled trial; Level of evidence, 2.
Methods


A randomized controlled trial was designed that entailed a superiority model for the intervention group. All professional dancers from a single ballet company were eligible to participate. Randomization and allocation were performed before the start of the season. The control group practiced and performed without change to preexisting standard operating practice. The IPP group was instructed to perform a 30-minute exercise program 3 times per week over the 52-week study period. Injuries were recorded. Standard continuous and categorical data comparisons and correlations were used. Cox proportional hazards regression models for recurrent failures were used wherein the hazard ratio indicates the relative likelihood of injury in the control versus intervention groups.
Results


Of the 52 eligible dancers, 75% (n = 39) participated. Of these 39 dancers, 19 (9 males, 10 females; mean age, 26.6 ± 4.0 years) were randomized to the control group and 20 (11 males, 9 females; mean age, 25.1 ± 5.1 years) to the IPP group. No significant ( P  > .05) difference was found in baseline demographics between groups. A total of 116 injuries were recorded for the entire study population (49 IPP; 67 control). Traumatic and chronic injuries accounted for 54% and 46% of injuries, respectively. The injury rate was 82% less (IPP hazard ratio, 0.18;  z  = -2.29;  P  = .022) in the IPP group after adjustment for confounding variables, and time between injuries was 45% longer (IPP hazard ratio, 0.55;  z  = -2.20;  P  = .028) than for controls.
Conclusion


The present study is the first prospective randomized controlled investigation of an IPP for professional ballet. The results showed an 82% decrease in injury rate for the intervention group and an extended period from previous injury to subsequent injury.
Registration


NCT04110002 (ClinicalTrials.gov identifier).",2020,"The injury rate was 82% less (IPP hazard ratio, 0.18;  ","['A total of 116 injuries were recorded for the entire study population (49 IPP; 67 control', 'Of these 39 dancers, 19 (9 males, 10 females; mean age, 26.6 ± 4.0 years) were randomized to the control group and 20 (11 males, 9 females; mean age, 25.1 ± 5.1 years) to the IPP group', 'Professional Ballet']",['IPP'],"['injury rate', 'Traumatic and chronic injuries']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0020823', 'cui_str': 'Ifosfamide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0335081', 'cui_str': 'Dancer'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0871967', 'cui_str': 'Ballet'}]","[{'cui': 'C0020823', 'cui_str': 'Ifosfamide'}]","[{'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]",116.0,0.131073,"The injury rate was 82% less (IPP hazard ratio, 0.18;  ","[{'ForeName': 'Angelina M', 'Initials': 'AM', 'LastName': 'Vera', 'Affiliation': 'Houston Methodist Orthopedics and Sports Medicine, Houston, Texas, USA.'}, {'ForeName': 'Bene D', 'Initials': 'BD', 'LastName': 'Barrera', 'Affiliation': 'Houston Methodist Orthopedics and Sports Medicine, Houston, Texas, USA.'}, {'ForeName': 'Leif E', 'Initials': 'LE', 'LastName': 'Peterson', 'Affiliation': 'Houston Methodist Orthopedics and Sports Medicine, Houston, Texas, USA.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Yetter', 'Affiliation': 'Houston Methodist Orthopedics and Sports Medicine, Houston, Texas, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dong', 'Affiliation': 'Houston Methodist Orthopedics and Sports Medicine, Houston, Texas, USA.'}, {'ForeName': 'Domenica A', 'Initials': 'DA', 'LastName': 'Delgado', 'Affiliation': 'Houston Methodist Orthopedics and Sports Medicine, Houston, Texas, USA.'}, {'ForeName': 'Patrick C', 'Initials': 'PC', 'LastName': 'McCulloch', 'Affiliation': 'Houston Methodist Orthopedics and Sports Medicine, Houston, Texas, USA.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Varner', 'Affiliation': 'Houston Methodist Orthopedics and Sports Medicine, Houston, Texas, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Harris', 'Affiliation': 'Houston Methodist Orthopedics and Sports Medicine, Houston, Texas, USA.'}]",Orthopaedic journal of sports medicine,['10.1177/2325967120937643']
2258,32782931,Planning and Implementation of Guided Self-study in an Undergraduate Physiotherapy Curriculum in Switzerland-A Feasibility Study.,"Background


Self-directed learning (andragogy) or self-determined learning (heutagogy) can be implemented in guided self-study (GSS) with the aim to foster changes in the knowledge and skills of physiotherapy students in a higher education setting. To date, there is a lack of evidence for the use of GSS in higher education for physiotherapy.
Aim


This study aimed to evaluate the feasibility of developing and implementing GSS in an undergraduate physiotherapy educational program in Switzerland. In addition, the effectiveness of GSS in bringing changes in knowledge and skills was assessed.
Method


Full-time undergraduate physiotherapy students (n = 49) from the third semester volunteered in this feasibility study. Students were randomly allocated into a GSS group or a control group (CG) in the period from October to November 2019. The GSS group prepared a total of 3 clinical cases. Each case was processed in an 8-day cycle. On day 1, the clinical case (ie, description of a patient and symptoms) and learning goals were provided to the students electronically. The students prepared the cases in groups from days 2 to 7. They were guided 2 times by the tutor (physical meeting and via Skype) during this preparation phase. The results of group work were presented and reflected on during a moderated plenum session (90 minutes) on day 8. The feasibility of this higher education study was operationalized as follows: exposure (""dose,"" ie, the number of GSS sessions performed over 90 minutes, as well as the content of the cases and the learning objectives); students' responsiveness, with an a priori set 100% willingness to participate on day 8; program differentiation, to illustrate differences between the content of GSS cases and the curriculum; and degree of acceptability. In addition, an assessment was made of the total scores in the objective structured clinical examination (OSCE) and written examinations, as well as the amount of GSS. Statistical analyses were conducted using an intention-to-treat approach.
Results


All 3 GSS sessions on day 8 lasted the scheduled 90 minutes. The content of the presented cases was aligned with the learning objectives. The responsiveness of students willing to participate on day 8 was 42%. In program differentiation, no differences in content were found between the GSS presentation content and the usual curriculum content when compared with the learning aims. Objective structured clinical examination grades and written examination grades were similar for the GSS and CG. The analysis of the focus group interview showed a low degree of acceptability indicating that the students' workload was high during the GSS period.
Conclusions


This study showed that this GSS program for undergraduate physiotherapy students in its current form is ""feasible with modification."" Modification of the study protocol (eg, better time planning in the academic calendar) is needed to improve the students' responsiveness. Alternatively, classroom hours may be reduced to favor self-study time. Such adjustments to the timetable should allow the physiotherapy students to better prepare the clinical cases. The effectiveness of the GSS and normal curriculum on OSCE and written examination scores was similar, probably due to the observed low students' acceptability.",2020,"In program differentiation, no differences in content were found between the GSS presentation content and the usual curriculum content when compared with the learning aims.","['undergraduate physiotherapy students', 'Method\n\n\nFull-time undergraduate physiotherapy students (n\u2009=\u200949) from the third semester volunteered in this feasibility study', 'undergraduate physiotherapy educational program in Switzerland']","['control group (CG', 'GSS', '\n\n\nSelf-directed learning (andragogy) or self-determined learning (heutagogy']",['OSCE and written examination scores'],"[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0682295', 'cui_str': 'Full-time employment'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0015730', 'cui_str': 'Feasibility Studies'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0183613,"In program differentiation, no differences in content were found between the GSS presentation content and the usual curriculum content when compared with the learning aims.","[{'ForeName': 'Slavko', 'Initials': 'S', 'LastName': 'Rogan', 'Affiliation': 'Department of Health Professions, Faculty of Physiotherapy, Bern University of Applied Sciences, Bern, Switzerland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Taeymans J', 'Affiliation': 'Department of Health Professions, Faculty of Physiotherapy, Bern University of Applied Sciences, Bern, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Zuber', 'Affiliation': 'Department of Health Professions, Faculty of Physiotherapy, Bern University of Applied Sciences, Bern, Switzerland.'}, {'ForeName': 'Evert', 'Initials': 'E', 'LastName': 'Zinzen', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium.'}]",Journal of medical education and curricular development,['10.1177/2382120520944921']
2259,32782954,"Effect of telmisartan and vitamin E on liver histopathology with non-alcoholic steatohepatitis: A randomized, open-label, noninferiority trial.","Background and Aim


To compare the effect of telmisartan and vitamin E on liver histopathology of non-alcoholic steatohepatitis (NASH) patients.
Methods


This noninferiority clinical trial was conducted for 1 year. Fatty liver patients with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥ 5 (in liver biopsy) were selected. All methods were in accordance with the Declaration of Helsinki. Patients who received telmisartan and vitamin E were denoted as Group-T and Group-E, respectively. Forty patients >18 years old were assigned and divided into two groups (20 in each group). Histological improvements were primary outcome measures.
Results


Significant improvement in NAS score was noted in both groups (Group E [GE]: 6 ± 0.8 to 4.36 ± 1.4;  P  = 0.00 and Group T [GT]: 5.6 ± 0.7to 4.9 ± 1.2;  P  = 0.03). Fibrosis score improved from 1.6 ± 0.5 to 1.5 ± 0.5 in GE and from 1.7 ± 0.9 to 1.5 ± 0.7 in GT ( P  = 0.67 and 0.42, respectively). Steatosis improved in GE from 2.07 ± 0.6 to 1.14 ± 0.66 ( P  = 0.00) and in GT from 1.94 ± 0.57 to 1.56 ± 0.8 ( P  = 0.05). Lobular inflammation improved from 2.0 ± 0.4 to 1.6 ± 0.5 in GE ( P  = 0.02) and from 1.9 ± 0.3 to 1.8 ± 0.4 in GT ( P  = 0.58). Ballooning score in GE decreased from 1.9 ± 0.3 to 1.7 ± 0.5 ( P  = 0.03), and in GT, it reduced from 1.9 ± 0.1 to 1.5 ± 0.5 ( P  = 0.19). NAS improvement was similar in GE (1.6 ± 1.2) and GT (0.6 ± 1.1;  P  = 0.07) when controlled for weight reduction.
Conclusion


Telmisartan was similar to vitamin E in improving the histology of NASH patients.",2020,Steatosis improved in GE from 2.07 ± 0.6 to 1.14 ± 0.66 ( P  = 0.00) and in GT from 1.94 ± 0.57 to 1.56 ± 0.8 ( P  = 0.05).,"['liver histopathology with non-alcoholic steatohepatitis', 'Fatty liver patients with non-alcoholic fatty liver disease (NAFLD) activity score (NAS)\u2009≥\u20095 (in liver biopsy', 'liver histopathology of non-alcoholic steatohepatitis (NASH) patients', 'Forty patients >18\u2009years old']","['telmisartan and vitamin E', 'Telmisartan', 'vitamin E']","['Fibrosis score', 'NAS score', 'NAS improvement', 'Lobular inflammation', 'Steatosis']","[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0243140', 'cui_str': 'histopathology'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0193388', 'cui_str': 'Biopsy of liver'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}]","[{'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027446', 'cui_str': 'National Academy of Sciences (U.S.)'}, {'cui': 'C0205417', 'cui_str': 'Lobular'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}]",,0.114847,Steatosis improved in GE from 2.07 ± 0.6 to 1.14 ± 0.66 ( P  = 0.00) and in GT from 1.94 ± 0.57 to 1.56 ± 0.8 ( P  = 0.05).,"[{'ForeName': 'Shahinul', 'Initials': 'S', 'LastName': 'Alam', 'Affiliation': 'Department of Hepatology Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh.'}, {'ForeName': 'Mushfiqul', 'Initials': 'M', 'LastName': 'Abrar', 'Affiliation': 'Department of Hepatology Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh.'}, {'ForeName': 'Saiful', 'Initials': 'S', 'LastName': 'Islam', 'Affiliation': 'Department of Hepatology Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Kamal', 'Affiliation': 'Department of Pathology Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh.'}, {'ForeName': 'Mohammad J', 'Initials': 'MJ', 'LastName': 'Hasan', 'Affiliation': 'Department of Medicine Pi Research Consultancy Center Dhaka Bangladesh.'}, {'ForeName': 'Md Abdullah S', 'Initials': 'MAS', 'LastName': 'Khan', 'Affiliation': 'Department of Medicine Shaheed Sayed Nazrul Islam Medical College Kishoreganj Bangladesh.'}, {'ForeName': 'Nooruddin', 'Initials': 'N', 'LastName': 'Ahmad', 'Affiliation': 'Department of Hepatology Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh.'}]",JGH open : an open access journal of gastroenterology and hepatology,['10.1002/jgh3.12315']
2260,32783220,Microcurrent electrotherapy improves palatal wound healing: randomized clinical trial.,"BACKGROUND


This study was conducted to assess the clinical, immunological, and patient-centered outcomes of microcurrent electrotherapy on palatal wound healing.
MATERIALS


This was a parallel, double-blind randomized clinical trial, in which 53 patients with ridge preservation indications were selected and randomly assigned to one of two groups. In the Control (Sham) group (n = 27), palatal wounds, after free gingival grafts (FGG) harvest, received sham application of electrotherapy. In the Test (EE) group (n = 26), palatal wounds, after FGG harvest, received application of microcurrent electrotherapy protocol. Clinical parameters, patient-centered outcomes, and inflammatory markers were evaluated, up to 90 days postoperatively.
RESULTS


The EE group achieved earlier wound closure (p <0.001) and epithelialization (p <0.05; p = 0.03) at 7 and 14 days after harvest when compared to the Sham group. Painful symptomatology was reported less frequently in the EE group than in the Sham group at 3-day follow-up (p = 0.008). Likewise, an improvement in Oral Health Impact Profile (OHIP) was reported 2 days after the procedure by the EE group (p = 0.04). In addition, favorable modulation of inflammatory wound healing markers occurred when electrotherapy was applied.
CONCLUSION


Within the limits of the present study, it can be concluded that the use of a low-intensity electrotherapy protocol may accelerate palatal wound healing and decrease patient discomfort after FGG harvest. This article is protected by copyright. All rights reserved.",2020,Painful symptomatology was reported less frequently in the EE group than in the Sham group at 3-day follow-up (p = 0.008).,['53 patients with ridge preservation indications'],"['microcurrent electrotherapy protocol', 'electrotherapy', 'Microcurrent electrotherapy', 'microcurrent electrotherapy']","['earlier wound closure', 'palatal wound healing', 'Painful symptomatology', 'inflammatory wound healing markers', 'epithelialization', 'Oral Health Impact Profile (OHIP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]","[{'cui': 'C0013787', 'cui_str': 'Electrotherapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0334029', 'cui_str': 'Epithelialization'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",53.0,0.134584,Painful symptomatology was reported less frequently in the EE group than in the Sham group at 3-day follow-up (p = 0.008).,"[{'ForeName': 'Manuela Maria Viana', 'Initials': 'MMV', 'LastName': 'Miguel', 'Affiliation': 'São Paulo State University (UNESP). Division of Periodontics, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Ingrid Fernandes', 'Initials': 'IF', 'LastName': 'Mathias-Santamaria', 'Affiliation': 'São Paulo State University (UNESP). Division of Periodontics, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Rossato', 'Affiliation': 'São Paulo State University (UNESP). Division of Periodontics, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Laís Fernanda Ferreira', 'Initials': 'LFF', 'LastName': 'Ferraz', 'Affiliation': 'São Paulo State University (UNESP). Division of Periodontics, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Antônio Martins Figueiredo', 'Initials': 'AMF', 'LastName': 'Neto', 'Affiliation': 'National Institute of Science and Technology (INCT-FCx) - Complex Fluids, São Paulo, Brazil.'}, {'ForeName': 'Andrea Carvalho', 'Initials': 'AC', 'LastName': 'de Marco', 'Affiliation': 'São Paulo State University (UNESP). Division of Periodontics, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Renato Corrêa Viana', 'Initials': 'RCV', 'LastName': 'Casarin', 'Affiliation': 'University of Campinas (UNICAMP). Department of Prosthodontics and Periodontics, Division of Periodontics, Piracicaba Dental School, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Shannon Margaret', 'Initials': 'SM', 'LastName': 'Wallet', 'Affiliation': 'University of North Carolina (UNC), School of Dentistry, Chapel Hill, NC, USA.'}, {'ForeName': 'Dimitris N', 'Initials': 'DN', 'LastName': 'Tatakis', 'Affiliation': 'The Ohio State University (OSU), College of Dentistry, Division of Periodontology, Columbus, OH, USA.'}, {'ForeName': 'Márcio Antônio', 'Initials': 'MA', 'LastName': 'Mathias', 'Affiliation': 'Iniciana Teaching Foundation (FEI). Department of Electrical Engineering, São Bernardo do Campo, São Paulo, Brazil.'}, {'ForeName': 'Mauro Pedrine', 'Initials': 'MP', 'LastName': 'Santamaria', 'Affiliation': 'São Paulo State University (UNESP). Division of Periodontics, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}]",Journal of periodontology,['10.1002/JPER.20-0122']
2261,32783238,"Suppression of Helicobacter pylori Infection by Daily Cranberry Intake: A Double-Blind, Randomized, Placebo-Controlled Trial.","BACKGROUND


Dietary strategies that contribute to reducing incidence of H. pylori infection without negative side effects are highly desirable due to worldwide bacterial prevalence and carcinogenesis potential.
AIM


To determine dosage effect of daily cranberry consumption on H. pylori suppression over time in infected adults to assess potential of this complementary management strategy in a region with high gastric cancer risk and high prevalence of H. pylori infection.
METHODS


This double-blind, randomized, placebo-controlled trial on 522 H. pylori-positive adults evaluated dose-response effects of proanthocyanidin-standardized cranberry juice, cranberry powder or their placebos on suppression of H. pylori at 2 and 8 weeks by  13  C-urea breath testing, and eradication at 45 days post-intervention.
RESULTS


H. pylori-negative rates in placebo, low-, medium- and high-proanthocyanidin cranberry juice groups at week 2 were 13.24%, 7.58%, 1.49% and 13.85%, and at week 8 were 7.35%, 7.58%, 4.48% and 20.00%, respectively. Consumption of high-proanthocyanidin juice twice daily (44 mg proanthocyanidin/240-mL serving) for 8 weeks resulted in decreased H. pylori infection rate by 20% compared to other dosages and placebo (P<0.05). Percentage of H. pylori-negative participants increased from 2 to 8 weeks in subjects that consumed 44 mg proanthocyanidin/day juice once or twice daily, showing a statistically significant positive trend over time. Encapsulated cranberry powder doses were not significantly effective at either time point. Overall trial compliance was 94.25%. Cranberry juice and powder were well-tolerated.
CONCLUSIONS


Twice-daily consumption of proanthocyanidin-standardized cranberry juice may help potentiate suppression of H. pylori infection.
TRIAL REGISTRATION


ChiCTR1800017522, per WHO ICTRP.",2020,"Percentage of H. pylori-negative participants increased from 2 to 8 weeks in subjects that consumed 44 mg proanthocyanidin/day juice once or twice daily, showing a statistically significant positive trend over time.","['a region with high gastric cancer risk and high prevalence of H. pylori infection', '522 H. pylori-positive adults', 'infected adults']","['Daily Cranberry Intake', 'Placebo', 'daily cranberry consumption', 'high-proanthocyanidin juice', 'proanthocyanidin-standardized cranberry juice', 'proanthocyanidin-standardized cranberry juice, cranberry powder or their placebos', 'proanthocyanidin', 'placebo, low-, medium- and high-proanthocyanidin cranberry juice', 'placebo']","['suppression of H. pylori', 'tolerated', 'Percentage of H. pylori-negative participants', 'Overall trial compliance', 'H. pylori infection rate']","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C4517804', 'cui_str': '522'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0072018', 'cui_str': 'Proanthocyanidin'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C1572601', 'cui_str': 'CRANBERRY JUICE'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}]",522.0,0.518413,"Percentage of H. pylori-negative participants increased from 2 to 8 weeks in subjects that consumed 44 mg proanthocyanidin/day juice once or twice daily, showing a statistically significant positive trend over time.","[{'ForeName': 'Zhe-Xuan', 'Initials': 'ZX', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Jun-Ling', 'Initials': 'JL', 'LastName': 'Ma', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Wei-Dong', 'Initials': 'WD', 'LastName': 'Liu', 'Affiliation': 'Linqu County Public Health Bureau, Shandong, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Linqu County Public Health Bureau, Shandong, China.'}, {'ForeName': 'Lan-Fu', 'Initials': 'LF', 'LastName': 'Zhang', 'Affiliation': 'Linqu County Public Health Bureau, Shandong, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Jing-Ying', 'Initials': 'JY', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Ha-Er', 'Initials': 'HE', 'LastName': 'Gao', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Xiao-Ying', 'Initials': 'XY', 'LastName': 'Guo', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Dong-Man', 'Initials': 'DM', 'LastName': 'Ye', 'Affiliation': 'Department of Medical Imaging, Liaoning Cancer Hospital & Institute, Cancer Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Wen-Qing', 'Initials': 'WQ', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Wei-Cheng', 'Initials': 'WC', 'LastName': 'You', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Kai-Feng', 'Initials': 'KF', 'LastName': 'Pan', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15212']
2262,32783267,Effect of dentin and fiber post surface treatments with fumaric acid on the bonding ability of fiber posts.,"This study investigated the effects of fumaric acid on push-out bond strength when applied to dentin surfaces and fiber posts. The root canals of 60 mandibular premolar teeth were instrumented and obturated. After removing two thirds of filling material, teeth were prepared according to six randomized groups (n = 10/group) defined by two fiber post surface treatments (0.7% fumaric acid or 9% hydrofluoric acid) and three dentin conditioning treatments [control (no conditioning); 17% ethylenediamine tetraacetic acid (EDTA); or 0.7% fumaric acid]. After fiber post-cementation, three 1-mm thick discs were obtained from each tooth by transverse sectioning, and each disc underwent push-out bond strength testing. Data were analyzed with a one-way analyses of variance (anova) and t tests; p < .05 was considered statistically significant. Failure modes were determined by stereomicroscopy, and the surface characteristics of dentin and fiber posts were observed by scanning electron microscopy. Push-out bond strength was greater for the group in which the post surface treated with hydrofluoric acid and the dentin surface treated with fumaric acid than the nontreated dentin and hydrofluoric acid-treated post group (p < .05). There were no significant differences between other comparison pairs (p > .05). A combination of fumaric acid dentin conditioning and hydrofluoric acid fiber post treatment strengthened the bonding ability of fiber posts.",2020,A combination of fumaric acid dentin conditioning and hydrofluoric acid fiber post treatment strengthened the bonding ability of fiber posts.,"['60 mandibular premolar teeth', 'fiber posts']","['fumaric acid', 'fumaric acid or 9% hydrofluoric acid', 'hydrofluoric acid', 'dentin conditioning treatments [control (no conditioning); 17% ethylenediamine tetraacetic acid (EDTA); or 0.7% fumaric acid']",['Push-out bond strength'],"[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0060825', 'cui_str': 'fumaric acid'}, {'cui': 'C0020274', 'cui_str': 'Hydrofluoric Acid'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015091', 'cui_str': 'Ethylenediamine'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C4517474', 'cui_str': '0.7'}]","[{'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]",,0.0162423,A combination of fumaric acid dentin conditioning and hydrofluoric acid fiber post treatment strengthened the bonding ability of fiber posts.,"[{'ForeName': 'Esma', 'Initials': 'E', 'LastName': 'Saricam', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Ankara Yildirim Beyazit University, Ankara, Turkey.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Arslan', 'Affiliation': 'Vocational School of Health Services, Kirikkale University, Kirikkale, Turkey.'}]",Microscopy research and technique,['10.1002/jemt.23562']
2263,32783280,Coverage of the external prostatic region by the hybrid method compared with the conventional method of prostate low-dose-rate brachytherapy: A randomized controlled study.,"OBJECTIVES


To compare the dose evaluation parameters between conventional (using loose seed alone) and hybrid (using loose seeds in combination with stranded seeds) low-dose rate brachytherapy for prostate cancer.
METHODS


Between 2014 and July 2016, a total of 219 patients who underwent low-dose rate brachytherapy were enrolled in a randomized controlled trial (trial number: UMIN 000012780). Patients were randomized and allocated to two groups (conventional method vs hybrid method). Post-dosimetric parameters (%D90, minimal percentage of the dose received by 90% of the prostate gland; V100, percentage of the prostate volume receiving 100% of the prescribed minimal peripheral dose; V150, percentage of the prostate volume receiving 150% of the prescribed minimal peripheral dose; %UD30, minimal percentage of the dose received by 30% of the urethra; R100, rectal volume [mL] receiving 100% of the prescribed dose) calculated at 1 month after seed implantation by computed tomography scan were compared between the two groups, as well as the post-dosimetric parameters using the planning target volume of the prostate + 5-mm margin.
RESULTS


Regarding dose evaluation parameters, the prostate dose (%D90, V100, V150) and the urethral dose (%UD30) were not significantly different between the two groups, whereas V100 (+5-mm margin) and %D90 (+5-mm margin) were significantly higher in the hybrid method group compared with the conventional method group (P < 0.001).
CONCLUSION


The present randomized study shows that the hybrid method of low-dose rate brachytherapy can achieve a higher coverage of the periprostatic region compared with the conventional method while maintaining an acceptable level of urethral and rectal doses.",2020,"Regarding dose evaluation parameters, the prostate dose (%D90, V100, V150) and the urethral dose (%UD30) were not significantly different between the two groups, whereas V100 (+5-mm margin) and %D90 (+5-mm margin) were significantly higher in the hybrid method group compared with the conventional method group (P < 0.001).
","['Between 2014 and July 2016, a total of 219 patients who underwent']","['conventional method of prostate low-dose-rate brachytherapy', 'low-dose rate brachytherapy', 'conventional (using loose seed alone) and hybrid (using loose seeds in combination with stranded seeds) low-dose rate brachytherapy']",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0454271', 'cui_str': 'Low dose rate brachytherapy'}, {'cui': 'C0205407', 'cui_str': 'Loose'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}]",[],219.0,0.0399957,"Regarding dose evaluation parameters, the prostate dose (%D90, V100, V150) and the urethral dose (%UD30) were not significantly different between the two groups, whereas V100 (+5-mm margin) and %D90 (+5-mm margin) were significantly higher in the hybrid method group compared with the conventional method group (P < 0.001).
","[{'ForeName': 'Nobumichi', 'Initials': 'N', 'LastName': 'Tanaka', 'Affiliation': 'Department of, Departments of, Urology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Asakawa', 'Affiliation': 'Department of, Radiation Oncology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Nakai', 'Affiliation': 'Department of, Departments of, Urology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Makito', 'Initials': 'M', 'LastName': 'Miyake', 'Affiliation': 'Department of, Departments of, Urology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Anai', 'Affiliation': 'Department of, Departments of, Urology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Yamaki', 'Affiliation': 'Department of, Radiation Oncology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Department of, Diagnostic Pathology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Hasegawa', 'Affiliation': 'Department of, Radiation Oncology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Kiyohide', 'Initials': 'K', 'LastName': 'Fujimoto', 'Affiliation': 'Department of, Departments of, Urology, Nara Medical University, Kashihara, Nara, Japan.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14349']
2264,32783330,Clinical efficacy and safety of nano-microneedle-assisted phenylethyl resorcinol for the treatment of infraorbital dark circles.,"BACKGROUND


Infraorbital dark circles (DC) are defined as a symptom that presents darkness under infraorbital eyelids. The objective of this study was to evaluate the efficacy and safety of nano-microneedle-assisted phenylethyl resorcinol (PR) for the treatment of infraorbital dark circles.
METHODS


Twenty female participants were randomized to two groups. In the experimental group (group E), participants received topical PR gel under the left orbit once a day and topical plus nano-microneedle-assisted PR gel under the right orbit twice a week. In the control group (group C), participants were treated with gel without PR. Melanin index (MI) and erythema index (EI) were measured before the session (T0), 4 and 8 weeks during the treatment session (T4, T8), and 1 and 2 months after the last session (T12, T16). The global assessment was performed by a blinded dermatologist.
RESULTS


The mean value of MI in group E was significantly lower than the baseline at T8 (P < .05), and the right side decreased more significantly than the left side (P < .05). However, there was no difference of MI before and after treatment in group C (P > .05). There was no big difference of the mean EI between the two sides (P > .05). The treatment was well tolerated, and no serious adverse effects were reported.
CONCLUSION


PR combined with nano-microneedle could be an effective and safe method for infraorbital DC.",2020,There was no big difference of the mean EI between the two sides (P > .05).,"['Twenty female participants', 'infraorbital dark circles']","['nano-microneedle-assisted phenylethyl resorcinol (PR', 'nano-microneedle-assisted phenylethyl resorcinol', 'gel without PR', 'topical PR gel under the left orbit once a day and topical plus nano-microneedle-assisted PR gel']","['MI', 'Melanin index (MI) and erythema index (EI', 'tolerated, and no serious adverse effects', 'efficacy and safety', 'mean EI', 'mean value of MI', 'right side']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1741338', 'cui_str': 'PHENYLETHYL RESORCINOL'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0029180', 'cui_str': 'Orbital cavity'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205090', 'cui_str': 'Right'}]",20.0,0.024334,There was no big difference of the mean EI between the two sides (P > .05).,"[{'ForeName': 'Cheng-Qian', 'Initials': 'CQ', 'LastName': 'Yu', 'Affiliation': 'Department of Dermatology, No. 1 Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Xue-Gang', 'Initials': 'XG', 'LastName': 'Xu', 'Affiliation': 'Department of Dermatology, No. 1 Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Hong-Duo', 'Initials': 'HD', 'LastName': 'Chen', 'Affiliation': 'Department of Dermatology, No. 1 Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Yuan-Hong', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, No. 1 Hospital of China Medical University, Shenyang, China.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13641']
2265,32780610,Role of low-molecular-weight heparin in altering uterine artery blood flow in recurrent spontaneous abortion: a prospective study.,"OBJECTIVE


This study aimed to determine the role of uterine artery blood flow (UABF) in recurrent spontaneous abortion (RSA) and to determine a viable option to promote the outcome of pregnancy.
METHODS


A total of 421 women were prospectively recruited for this research. UABF indices, including the systolic/diastolic ratio, pulsatility index and resistance index, during the midluteal phase were compared between patients with RSA and women without RSA (controls). After low-molecular-weight heparin (LMWH) was administered to patients with RSA, indices at 7, 10, and 12 weeks of gestation were compared between the two groups.
RESULTS


UABF indices during the midluteal phase were significantly higher in the RSA group than in the control group. After LMWH was administered to the RSA group, UABF indices in the first trimester were similar to those in the control group. The rate of spontaneous miscarriage was also similar between the groups after LMWH treatment.
CONCLUSIONS


Our study shows that sufficient uterine perfusion is crucial for a successful pregnancy. LMWH reduces the rate of spontaneous miscarriage in patients with RSA to a similar rate in women without RSA. LMWH might play a role in decreasing UABF resistance and increasing uterine perfusion.",2020,"RESULTS


UABF indices during the midluteal phase were significantly higher in the RSA group than in the control group.","['recurrent spontaneous abortion', 'recurrent spontaneous abortion (RSA', 'A total of 421 women were prospectively recruited for this research', 'patients with RSA']","['LMWH', 'RSA', 'low-molecular-weight heparin (LMWH', 'uterine artery blood flow (UABF', 'low-molecular-weight heparin']","['rate of spontaneous miscarriage', 'uterine artery blood flow', 'UABF indices', 'systolic/diastolic ratio, pulsatility index and resistance index', 'UABF resistance']","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0226378', 'cui_str': 'Structure of uterine artery'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0226378', 'cui_str': 'Structure of uterine artery'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",421.0,0.0464912,"RESULTS


UABF indices during the midluteal phase were significantly higher in the RSA group than in the control group.","[{'ForeName': 'Kemei', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Reproductive Medicine Centre, Ningbo First Hospital, Zhejiang, China.'}, {'ForeName': 'Ensheng', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': 'Reproductive Medicine Centre, Ningbo First Hospital, Zhejiang, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Reproductive Medicine Centre, Ningbo First Hospital, Zhejiang, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Reproductive Medicine Centre, Ningbo First Hospital, Zhejiang, China.'}, {'ForeName': 'Jiaou', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Reproductive Medicine Centre, Ningbo First Hospital, Zhejiang, China.'}, {'ForeName': 'Xuhong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Ultrosonic Department, Ningbo First Hospital, Zhejiang, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shu', 'Affiliation': 'Reproductive Medicine Centre, Ningbo First Hospital, Zhejiang, China.'}]",The Journal of international medical research,['10.1177/0300060520945558']
2266,32780617,Using Physical Food Transformation to Enhance the Sensory Approval of Children with Autism Spectrum Disorders for Consuming Fruits and Vegetables.,"Introduction:  Children with autistic spectrum disorders (ASD) commonly exhibit aberrant tactile, taste, and smell sensitivity to foods. Food transformation that alters the appearance, texture, and temperature of foods is promising for solving this sensitivity problem.  Objectives:  This study evaluated the effect of physical transformation of fruits and vegetables (FV) to snacks to enhance ASD children's sensory approval for eating them.  Design:  This was a quasiexperimental design study. It lasted for 4 weeks with three episodes of FV exposure to the ASD children per week. The original condition was conducted in the first and fourth week, while intervention was performed in the second and third week.  Settings:  Food exposure took place in schools in a quiet room.  Subjects:  This study recruited 56 ASD children.  Intervention:  Food transformation constituted changing bananas into ice-cream, zucchinis and sweet potatoes into chips, apples and kiwis into popsicles, and carrots into juice.  Outcome Measures:  FV acceptance and habitual consumption were measured at baseline and postintervention.  Results:  ASD children increased their consumption of all FV, but only banana consumption was statistically significant from 55.3 to 78.0 g ( p  < 0.05). For habitual consumption, parents reported increases in all FV consumption for all three measured fruits and 2 of 3 measures of vegetables (pre vs. post mean for bananas: 2.4 vs. 2.9, apples 2.6 vs. 3.2, kiwis 2.4 vs. 2.9, zucchinis 1.9 vs. 2.5, and sweet potatoes 1.8 vs. 2.4;  p  < 0.05).  Conclusion:  Physical changes of foods may improve impaired sensory processing of ASD children to promote their FV acceptance. Project Code: RG 55/2019-2020R.",2020,"ASD children increased their consumption of all FV, but only banana consumption was statistically significant from 55.3 to 78.0 g ( p  < 0.05).","['56 ASD children', 'Children with autistic spectrum disorders (ASD', 'Subjects', 'Children with Autism Spectrum Disorders for Consuming Fruits and Vegetables']","['physical transformation of fruits and vegetables (FV) to snacks', 'Food transformation constituted changing bananas into ice-cream, zucchinis and sweet potatoes into chips, apples and kiwis into popsicles, and carrots into juice', 'Food exposure']","['FV acceptance and habitual consumption', 'banana consumption', 'FV consumption']","[{'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3714584', 'cui_str': 'Transformation'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0004722', 'cui_str': 'Banana'}, {'cui': 'C0020747', 'cui_str': 'Ice cream'}, {'cui': 'C0331252', 'cui_str': 'Ipomoea batatas'}, {'cui': 'C0057856', 'cui_str': 'iproplatin'}, {'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C0999170', 'cui_str': 'Apteryx'}, {'cui': 'C3853215', 'cui_str': 'Popsicle'}, {'cui': 'C1141640', 'cui_str': 'Carrot'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0004722', 'cui_str': 'Banana'}]",56.0,0.0210702,"ASD children increased their consumption of all FV, but only banana consumption was statistically significant from 55.3 to 78.0 g ( p  < 0.05).","[{'ForeName': 'Louisa Ming Yan', 'Initials': 'LMY', 'LastName': 'Chung', 'Affiliation': 'Department of Health and Physical Education, The Education University of Hong Kong, Tai Po, Hong Kong.'}, {'ForeName': 'Queenie Pui Sze', 'Initials': 'QPS', 'LastName': 'Law', 'Affiliation': 'School of Nursing, Tung Wah College, Kowloon, Hong Kong.'}, {'ForeName': 'Shirley Siu Ming', 'Initials': 'SSM', 'LastName': 'Fong', 'Affiliation': 'School of Public Health, The University of Hong Kong, Pokfulam, Hong Kong.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0215']
2267,32780632,Low-Energy Extracorporeal Shockwave Therapy as a Therapeutic Option for Patients with a Secondary Late-Stage Fibro-Lymphedema After Breast Cancer Therapy: A Pilot Study.,"Background:  Secondary lymphedema (LE) can occur after breast cancer (BC) therapy with axillary lymph node surgery and/or radiotherapy. Reported incidence varies around 20%. The aim of this study was to see whether low-energy extracorporeal shockwave therapy (ESWT) is a therapeutic option in end-stage secondary upper limb fibro-LE.  Methods and Results:  A pilot study was performed on 10 adult patients who presented with an end-stage LE after BC treatment. They were all treated with usual physical therapy and all had lymphatic surgery before. Eight sessions of ESWT were applied, 2600 shocks at 0.1 mJ/mm 2 , 2/week during 4 weeks. Upper limb volume decreased nonsignificantly, from 3086.4 ± 539.47 to 2909.1 ± 471.60 mL. Mean circumference of the upper limb was significantly decreased from 32.3 ± 3.01 to 31.4 ± 2.71 cm at the height of the upper arm, from 29.1 ± 2.89 to 28.1 ± 2.71 cm at the height of the elbow, and from 27.5 ± 4.08 to 26.8 ± 3.75 cm at the height of the forearm. Subjective measurements by visual analog scale showed significant decrease in both hardness from 57.3 ± 15.84 to 24.4 ± 21.89 mm and subjective feeling of edema from 44.2 ± 16.90 to 23.2 ± 21.16 mm. No adverse features were reported.  Conclusion:  We added some evidence that low-energy ESWT is well supported and has additional benefits also in longstanding fibro-lipo-LE on swelling of the arm leading to more subjective comfort for the patients.",2020,"Mean circumference of the upper limb was significantly decreased from 32.3 ± 3.01 to 31.4 ± 2.71 cm at the height of the upper arm, from 29.1 ± 2.89 to 28.1 ± 2.71 cm at the height of the elbow, and from 27.5 ± 4.08 to 26.8 ± 3.75 cm at the height of the forearm.","['10 adult patients who presented with an end-stage LE after BC treatment', 'Patients with a Secondary Late-Stage Fibro-Lymphedema']","['usual physical therapy', 'breast cancer (BC) therapy with axillary lymph node surgery and/or radiotherapy', 'Low-Energy Extracorporeal Shockwave Therapy', 'ESWT', 'low-energy extracorporeal shockwave therapy (ESWT']","['Upper limb volume', 'Mean circumference of the upper limb']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}]",10.0,0.0289505,"Mean circumference of the upper limb was significantly decreased from 32.3 ± 3.01 to 31.4 ± 2.71 cm at the height of the upper arm, from 29.1 ± 2.89 to 28.1 ± 2.71 cm at the height of the elbow, and from 27.5 ± 4.08 to 26.8 ± 3.75 cm at the height of the forearm.","[{'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Joos', 'Affiliation': 'Department of Physical Medicine and Rehabilitation and UZ Brussels, Brussels, Belgium.'}, {'ForeName': 'Ina', 'Initials': 'I', 'LastName': 'Vultureanu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation and UZ Brussels, Brussels, Belgium.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Nonneman', 'Affiliation': 'Department of Physical Medicine and Rehabilitation and UZ Brussels, Brussels, Belgium.'}, {'ForeName': 'Nele', 'Initials': 'N', 'LastName': 'Adriaenssens', 'Affiliation': 'Lymphology Clinic & European Center of Lymphatic Surgery, UZ Brussels, Brussels, Belgium.'}, {'ForeName': 'Moustapha', 'Initials': 'M', 'LastName': 'Hamdi', 'Affiliation': 'Lymphology Clinic & European Center of Lymphatic Surgery, UZ Brussels, Brussels, Belgium.'}, {'ForeName': 'Assaf', 'Initials': 'A', 'LastName': 'Zeltzer', 'Affiliation': 'Lymphology Clinic & European Center of Lymphatic Surgery, UZ Brussels, Brussels, Belgium.'}]",Lymphatic research and biology,['10.1089/lrb.2020.0033']
2268,32780636,Dextrose Prolotherapy Versus Lidocaine Injection for Temporomandibular Dysfunction: A Pragmatic Randomized Controlled Trial.,"Objective:  Several intraarticular injections, including dextrose and lidocaine, are reported to reduce pain and dysfunction in temporomandibular dysfunction (TMD) and increase maximal jaw opening; our goal was to determine whether dextrose/lidocaine outperforms sterile water/lidocaine for TMD.  Design:  Pragmatic randomized controlled trial.  Setting:  Outpatient clinic.  Subjects:  Chronic (≥3 months) of moderate-to-severe (≥6/10) jaw or facial pain meeting research-specific TMD criteria.  Intervention:  Blinded intraarticular dextrose prolotherapy (DPT) (20% dextrose/0.2% lidocaine) versus intraarticular lidocaine (0.2% lidocaine in sterile water) at 0, 1, and 2 months. Participants were then unblinded and offered DPT by request for 9 additional months.  Main outcome measures:  Primary: Numerical Rating Scale (0-10 points) score for facial pain and jaw dysfunction; percentage achieving ≥50% improvement in pain and dysfunction (0, 3, and 12 months). Secondary: Maximal interincisal opening (MIO; 0 and 3 months). Intention-to-treat analysis was by joint using mixed-model regression.  Results:  Randomization of 29 participants (25 female, 47 ± 17 years, 43 joints) produced similar groups. Three-month pain and dysfunction improvements were similar, but more DPT-treated joints improved by ≥50% in pain (17/22 vs. 6/21;  p  = 0.028). The MIO improved in both groups (5.6 ± 5.8 mm vs. 5.1 ± 7.0 mm;  p  = 0.70). From 3 to 12 months, minimal DPT was received by original DPT and lidocaine recipients, 0.5 ± 0.9 and 0.6 ± 1.5 injections, respectively, with only 2 out of 21 joints in the original lidocaine group receiving more than 1 dextrose injection after 3 months. Twelve-month analysis revealed that joints in the original DPT group improved more in jaw pain (4.8 ± 2.4 points vs. 2.6 ± 2.9 points;  p  = 0.026) and jaw dysfunction (5.3 ± 2.6 points vs. 2.7 ± 2.3 points;  p  = 0.013). More DPT than lidocaine-treated joints improved by ≥50% in both pain (19/22 vs. 5/21;  p  = 0.003) and dysfunction (17/22 vs. 7/21;  p  = 0.040). There were no adverse events; satisfaction was high.  Conclusions:  Intraarticular DPT resulted in clinically important and statistically significant improvement in pain and dysfunction at 12 months compared to lidocaine injection (ClinicalTrials.gov identifier NCT01617356).",2020,Intraarticular DPT resulted in clinically important and statistically significant improvement in pain and dysfunction at 12 months compared to lidocaine injection (ClinicalTrials.gov identifier NCT01617356).,"['Subjects:  Chronic (≥3 months) of moderate-to-severe (≥6/10) jaw or facial pain meeting research-specific TMD criteria', '29 participants (25 female, 47\u2009±\u200917 years, 43 joints) produced similar groups', 'Temporomandibular Dysfunction']","['intraarticular lidocaine (0.2% lidocaine', 'lidocaine', 'Dextrose Prolotherapy Versus Lidocaine Injection', 'dextrose/lidocaine', 'intraarticular dextrose prolotherapy (DPT) (20% dextrose/0.2% lidocaine', 'Intraarticular DPT', 'dextrose and lidocaine']","['pain and dysfunction in temporomandibular dysfunction (TMD', 'pain and dysfunction', 'MIO', 'Maximal interincisal opening (MIO; 0 and 3 months', 'jaw dysfunction', 'adverse events; satisfaction', 'dysfunction', 'jaw pain', 'Numerical Rating Scale (0-10 points) score for facial pain and jaw dysfunction; percentage achieving ≥50% improvement in pain and dysfunction', 'pain and dysfunction improvements']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]","[{'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0500223', 'cui_str': 'Prolotherapy'}, {'cui': 'C4049857', 'cui_str': 'Lidocaine Injection'}, {'cui': 'C0636923', 'cui_str': 'diphenylthiosulfinate'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0236000', 'cui_str': 'Jaw pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",,0.326994,Intraarticular DPT resulted in clinically important and statistically significant improvement in pain and dysfunction at 12 months compared to lidocaine injection (ClinicalTrials.gov identifier NCT01617356).,"[{'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Zarate', 'Affiliation': 'Private Practice Family Medicine, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Ricardo Daniel', 'Initials': 'RD', 'LastName': 'Frusso', 'Affiliation': 'Private Practice Family Medicine, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Kenneth Dean', 'Initials': 'KD', 'LastName': 'Reeves', 'Affiliation': 'Private Practice Physical Medicine and Rehabilitation, Roeland, Kansas, USA.'}, {'ForeName': 'An-Lin', 'Initials': 'AL', 'LastName': 'Cheng', 'Affiliation': 'Department of Biomedical and Health Informatics, University of Missouri Kansas City School of Medicine, Kansas City, Missouri.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rabago', 'Affiliation': 'Department of Family and Community Medicine, Penn State College of Medicine, Hershey, Pennsylvania, USA.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0207']
2269,32780744,Comparison of alternative full and brief versions of functional status scales among older adults in China.,"BACKGROUND


Brief assessments of functional status for community-dwelling older adults are needed given expanded interest in the measurement of functional decline.
METHODS


As part of a 2015 prospective cohort study of older adults aged 60-89 years in Jiangsu Province, China, 1506 participants were randomly assigned to two groups; each group was administered one of two alternative 20-item versions of a scale to assess activities of daily living (ADL) and instrumental activities of daily living (IADL) drawn from multiple commonly-used scales. One version asked if they required help to perform activities (ADL-IADL-HELP-20), while the other version provided additional response options if activities could be done alone but with difficulty (ADL-IADL-DIFFICULTY-20). Item responses to both versions were compared using the binomial test for differences in proportion (with Wald 95% confidence interval [CI]). A brief 9-item scale (ADL-IADL-DIFFICULTY-9) was developed favoring items identified as difficult or requiring help by ≥4%, with low redundancy and/or residual correlations, and with significant correlations with age and other health indicators. We repeated assessment of the measurement properties of the brief scale in two subsequent samples of older adults in Hong Kong in 2016 (aged 70-79 years; n = 404) and 2017 (aged 65-82 years; n = 1854).
RESULTS


Asking if an activity can be done alone but with difficulty increased the proportion of participants reporting restriction on 9 of 20 items, for which 95% CI for difference scores did not overlap with zero; the proportion with at least one limitation increased from 28.6% to 34.2% or an absolute increase of 5.6% (95% CI = 0.9-10.3%), which was a relative increase of 19.6%. The brief ADL-IADL-DIFFICULTY-9 maintained excellent internal consistency (α = 0.93) and had similar ceiling effect (68.1%), invariant item ordering (H trans = .41; medium), and correlations with age and other health measures compared with the 20-item version. The brief scale performed similarly when subsequently administered to older adults in Hong Kong.
CONCLUSIONS


Asking if tasks can be done alone but with difficulty can modestly reduce ceiling effects. It's possible that the length of commonly-used scales can be reduced by over half if researchers are primarily interested in a summed indicator rather than an inventory of specific types of deficits.",2020,"Asking if an activity can be done alone but with difficulty increased the proportion of participants reporting restriction on 9 of 20 items, for which 95% CI for difference scores did not overlap with zero; the proportion with at least one limitation increased from 28.6% to 34.2% or an absolute increase of 5.6% (95% CI = 0.9-10.3%), which was a relative increase of 19.6%.","['older adults in Hong Kong', 'older adults in Hong Kong in 2016 (aged 70-79 years; n = 404) and 2017 (aged 65-82 years; n = 1854', 'community-dwelling older adults', 'older adults in China', 'older adults aged 60-89 years in Jiangsu Province, China, 1506 participants']",[],['activities of daily living (ADL) and instrumental activities of daily living (IADL'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008115', 'cui_str': 'China'}]",[],"[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}]",1506.0,0.113087,"Asking if an activity can be done alone but with difficulty increased the proportion of participants reporting restriction on 9 of 20 items, for which 95% CI for difference scores did not overlap with zero; the proportion with at least one limitation increased from 28.6% to 34.2% or an absolute increase of 5.6% (95% CI = 0.9-10.3%), which was a relative increase of 19.6%.","[{'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Reich', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Thompson', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Cowling', 'Affiliation': 'WHO Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'A Danielle', 'Initials': 'AD', 'LastName': 'Iuliano', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Greene', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Yuyun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'WHO Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Phadnis', 'Affiliation': 'Abt Associates, Cambridge, Massachusetts, United States of America.'}, {'ForeName': 'Nancy H L', 'Initials': 'NHL', 'LastName': 'Leung', 'Affiliation': 'WHO Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Vicky J', 'Initials': 'VJ', 'LastName': 'Fang', 'Affiliation': 'WHO Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Cuiling', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Chinese National Influenza Center, National Institute for Viral Disease Control and Prevention, Collaboration Innovation Center for Diagnosis and Treatment of Infectious Diseases, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Qigang', 'Initials': 'Q', 'LastName': 'Dai', 'Affiliation': 'Department of Acute Infectious Disease Control and Prevention, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Suzhou Center for Disease Prevention and Control, Suzhou, China.'}, {'ForeName': 'Hongjun', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Yancheng Center for Disease Prevention and Control, Yancheng, China.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Havers', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0234698']
2270,32780751,Implementation of an automated scheduling tool improves schedule quality and resident satisfaction.,"Rotation schedules for residents must balance individual preferences, compliance with Accreditation Council for Graduate Medical Education guidelines, and institutional staffing requirements. Automation has the potential to improve the consistency and quality of schedules. We designed a novel rotation scheduling tool, the Automated Internal Medicine Scheduler (AIMS), and evaluated schedule quality and resident satisfaction and perceptions of fairness after implementation. We compared schedule uniformity, fulfillment of resident preferences, and conflicting shift assignments for the hand-made 2017-2018 schedule, and the AIMS-generated 2018-2019 schedule. Residents were surveyed in September 2018 to assess perception of schedule quality and fairness. With AIMS, 71/74 (96.0%) interns and 66/82 (80.5%) residents were assigned to their first-choice rotation, a significant increase from the 50/72 (69.4%) interns and 25/82 (30.5%) residents assigned their first-choice in the 2017-2018 academic year. AIMS also yielded significant improvements in the number of night shift/day shift conflicts at the time of rotation switches for interns, with a significant decrease to 0.3 conflicts per intern compared to 0.7 with the prior manual schedule. Twenty-two of 82 residents (27%) completed the survey, and average satisfaction and perception of fairness were 0.7 and 0.9 points higher on a 5-point Likert scale for the AIMS-generated schedule when compared to the non-AIMS schedule. There was no significant difference in the preference for assigned vacation blocks, or in variance for night or ICU rotations. Automated scheduling improved several metrics of schedule quality, as well as resident satisfaction. Future directions include evaluation of the tool in other residency programs and comparison with alternative scheduling algorithms.",2020,"AIMS also yielded significant improvements in the number of night shift/day shift conflicts at the time of rotation switches for interns, with a significant decrease to 0.3 conflicts per intern compared to 0.7 with the prior manual schedule.",['residents assigned their first-choice in the 2017-2018 academic year'],[],"['number of night shift/day shift conflicts', 'schedule quality and resident satisfaction', 'average satisfaction and perception of fairness']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0266697,"AIMS also yielded significant improvements in the number of night shift/day shift conflicts at the time of rotation switches for interns, with a significant decrease to 0.3 conflicts per intern compared to 0.7 with the prior manual schedule.","[{'ForeName': 'Frederick M', 'Initials': 'FM', 'LastName': 'Howard', 'Affiliation': 'Section of Hematology/Oncology, Department of Medicine, University of Chicago, Chicago, Illinois, United States of America.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Gao', 'Affiliation': 'Division of Pulmonary/Critical Care, Department of Medicine, Northwestern University, Chicago, Illinois, United States of America.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Sankey', 'Affiliation': 'Department of Internal Medicine, Yale New Haven Hospital, New Haven, Connecticut, United States of America.'}]",PloS one,['10.1371/journal.pone.0236952']
2271,32780752,Response to photodynamic therapy combined with intravitreal aflibercept for polypoidal choroidal vasculopathy depending on fellow-eye condition:2-year results.,"We investigated whether response to photodynamic therapy (PDT) with intravitreal aflibercept injection (IAI) for polypoidal choroidal vasculopathy (PCV) differs depending on fellow eye condition. A retrospective review was conducted for consecutive 60 eyes with PCV treated with PDT combined with IAI as well as 2-years of follow-up data. Fellow eyes were divided into 4 groups; Group 0: no drusen, Group 1; pachydrusen, Group 2; soft drusen, Group 3: PCV/fibrovascular scarring. Best-corrected visual acuity improved at 24-months irrespective of groups and there were no significant differences in visual improvement among treated eyes among the 4 groups. Within 2-years, 35 (58.3%) required the retreatment. The need for retreatment including additional injection and the combination therapy was significantly less in Group 1(12.5%) compared to the others (P = 0.0038) and mean number of additional IAI was also less in Group 1 compared to the others (P = 0.017). The retreatment-free period from the initial combination therapy was longest in Group 1 (23.6±1.1 months) (P = 0.0055, Group 0: 19.1±6.9, Group 2: 12.8±7.9, Group 3: 11.5±9.9). The need for retreatment was significantly different according to fellow-eye condition. Among PCV patients, pachydrusen in fellow eyes appear to be a predictive characteristic for a decreased treatment burden at 2 years.",2020,Best-corrected visual acuity improved at 24-months irrespective of groups and there were no significant differences in visual improvement among treated eyes among the 4 groups.,"['consecutive 60 eyes with PCV treated with PDT combined with IAI as well as 2-years of follow-up data', 'polypoidal choroidal vasculopathy depending on fellow-eye condition:2-year results']","['PCV/fibrovascular scarring', 'photodynamic therapy (PDT) with intravitreal aflibercept injection (IAI', 'photodynamic therapy combined with intravitreal aflibercept']","['Best-corrected visual acuity', 'visual improvement', 'mean number of additional IAI']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1504336', 'cui_str': 'Polypoidal choroidal vasculopathy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C0104281', 'cui_str': 'AS 2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C1504336', 'cui_str': 'Polypoidal choroidal vasculopathy'}, {'cui': 'C0392759', 'cui_str': 'Fibrovascular'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}]",60.0,0.0237003,Best-corrected visual acuity improved at 24-months irrespective of groups and there were no significant differences in visual improvement among treated eyes among the 4 groups.,"[{'ForeName': 'Mio', 'Initials': 'M', 'LastName': 'Matsubara', 'Affiliation': 'Departments of Ophthalmology, Faculty of Medicine, University of Yamanashi, Kofu, Yamanashi, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Sakurada', 'Affiliation': 'Departments of Ophthalmology, Faculty of Medicine, University of Yamanashi, Kofu, Yamanashi, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Sugiyama', 'Affiliation': 'Departments of Ophthalmology, Faculty of Medicine, University of Yamanashi, Kofu, Yamanashi, Japan.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Fukuda', 'Affiliation': 'Departments of Ophthalmology, Faculty of Medicine, University of Yamanashi, Kofu, Yamanashi, Japan.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Parikh', 'Affiliation': 'New York University School of Medicine, New York, NY, United States of America.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kashiwagi', 'Affiliation': 'Departments of Ophthalmology, Faculty of Medicine, University of Yamanashi, Kofu, Yamanashi, Japan.'}]",PloS one,['10.1371/journal.pone.0237330']
2272,32780794,A randomized crossover trial on the effect of plant-based compared with animal-based meat on trimethylamine-N-oxide and cardiovascular disease risk factors in generally healthy adults: Study With Appetizing Plantfood-Meat Eating Alternative Trial (SWAP-MEAT).,"BACKGROUND


Despite the rising popularity of plant-based alternative meats, there is limited evidence of the health effects of these products.
OBJECTIVES


We aimed to compare the effect of consuming plant-based alternative meat (Plant) as opposed to animal meat (Animal) on health factors. The primary outcome was fasting serum trimethylamine-N-oxide (TMAO). Secondary outcomes included fasting insulin-like growth factor 1, lipids, glucose, insulin, blood pressure, and weight.
METHODS


SWAP-MEAT (The Study With Appetizing Plantfood-Meat Eating Alternatives Trial) was a single-site, randomized crossover trial with no washout period. Participants received Plant and Animal products, dietary counseling, lab assessments, microbiome assessments (16S), and anthropometric measurements. Participants were instructed to consume ≥2 servings/d of Plant compared with Animal for 8 wk each, while keeping all other foods and beverages as similar as possible between the 2 phases.
RESULTS


The 36 participants who provided complete data for both crossover phases included 67% women, were 69% Caucasian, had a mean ± SD age 50 ± 14 y, and BMI 28 ± 5 kg/m2. Mean ± SD servings per day were not different by intervention sequence: 2.5 ± 0.6 compared with 2.6 ± 0.7 for Plant and Animal, respectively (P = 0.76). Mean ± SEM TMAO concentrations were significantly lower overall for Plant (2.7 ± 0.3) than for Animal (4.7 ± 0.9) (P = 0.012), but a significant order effect was observed (P = 0.023). TMAO concentrations were significantly lower for Plant among the n = 18 who received Plant second (2.9 ± 0.4 compared with 6.4 ± 1.5, Plant compared with Animal, P = 0.007), but not for the n = 18 who received Plant first (2.5 ± 0.4 compared with 3.0 ± 0.6, Plant compared with Animal, P = 0.23). Exploratory analyses of the microbiome failed to reveal possible responder compared with nonresponder factors. Mean ± SEM LDL-cholesterol concentrations (109.9 ± 4.5 compared with 120.7 ± 4.5 mg/dL, P = 0.002) and weight (78.7 ± 3.0 compared with 79.6 ± 3.0 kg, P < 0.001) were lower during the Plant phase.
CONCLUSIONS


Among generally healthy adults, contrasting Plant with Animal intake, while keeping all other dietary components similar, the Plant products improved several cardiovascular disease risk factors, including TMAO; there were no adverse effects on risk factors from the Plant products.This trial was registered at clinicaltrials.gov as NCT03718988.",2020,"Mean ± SEM TMAO concentrations were significantly lower overall for Plant (2.7 ± 0.3) than for Animal (4.7 ± 0.9) (P = 0.012), but a significant order effect was observed (P = 0.023).","['36 participants who provided complete data for both crossover phases included 67% women, were 69% Caucasian, had a mean\xa0±\xa0SD age 50\xa0±', 'generally healthy adults']","['consuming plant-based alternative meat (Plant', 'Plant and Animal products, dietary counseling, lab assessments, microbiome assessments (16S), and anthropometric measurements', 'SWAP-MEAT ', 'plant-based compared with animal-based meat on trimethylamine-N-oxide']","['fasting insulin-like growth factor 1, lipids, glucose, insulin, blood pressure, and weight', 'Mean\xa0±', 'weight', 'Mean\xa0±\xa0SEM LDL-cholesterol concentrations', 'TMAO concentrations', 'fasting serum trimethylamine-N-oxide (TMAO', 'Mean\xa0±\xa0SEM TMAO concentrations']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0025018', 'cui_str': 'Meat products'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.0987864,"Mean ± SEM TMAO concentrations were significantly lower overall for Plant (2.7 ± 0.3) than for Animal (4.7 ± 0.9) (P = 0.012), but a significant order effect was observed (P = 0.023).","[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Crimarco', 'Affiliation': 'Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Sparkle', 'Initials': 'S', 'LastName': 'Springfield', 'Affiliation': 'Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Petlura', 'Affiliation': 'Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Streaty', 'Affiliation': 'Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Cunanan', 'Affiliation': 'Quantitative Sciences Unit, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Quantitative Sciences Unit, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Fielding-Singh', 'Affiliation': 'Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Carter', 'Affiliation': 'Microbiology and Immunology, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Madeline A', 'Initials': 'MA', 'LastName': 'Topf', 'Affiliation': 'Microbiology and Immunology, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Hannah C', 'Initials': 'HC', 'LastName': 'Wastyk', 'Affiliation': 'Microbiology and Immunology, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Erica D', 'Initials': 'ED', 'LastName': 'Sonnenburg', 'Affiliation': 'Microbiology and Immunology, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Justin L', 'Initials': 'JL', 'LastName': 'Sonnenburg', 'Affiliation': 'Microbiology and Immunology, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Gardner', 'Affiliation': 'Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa203']
2273,32780797,Effects of Osteopathic Manipulative Treatment on Sleep Quality in Student Athletes After Concussion: A Pilot Study.,"Context


Impaired sleep quality is among many symptoms observed in patients with a concussion and may predispose a patient to a prolonged recovery course and a later return to their daily activities. Studies have suggested that osteopathic manipulative treatment (OMT) may play a role in improving sleep quality.
Objective


To investigate how OMT may play a role in the management and overall healing process in patients with a concussion by improving sleep quality.
Methods


Data were collected from a randomized, controlled study on OMT and concussion (of which this study represents 1 arm) to investigate the effects of OMT vs concussion education counseling on sleep quality in student athletes with a concussion. Student athletes with no medical history of neurodegenerative disease who presented to the New York Institute of Technology College of Osteopathic Medicine Academic Healthcare Center with a concussion following a sport-related injury were enrolled in the study. Participants received OMT intervention or standard counseling on how to care for a concussion during their first and second visits. Participants rated their symptoms, including sleep quality, on the validated scale Sport Concussion Assessment Tool 5th Edition at 3 consecutive visits during 1 week. The mean sleep quality score within and between the OMT and education groups before each of 2 interventions and at the third visit were compared and analyzed using the Mann-Whitney U test.
Results


Thirty participants were enrolled in the study. Total symptom data showed a stronger, significant correlation with sleep scores than with other symptoms. Participants receiving OMT (n=16) reported overall 80% and 76% improvement in sleep quality from pre-OMT values to their second and third visits, respectively. Participants who had an educational intervention (n=14) reported a 36% and 46% improvement from pre-OMT values to their second and third visits, respectively.
Conclusion


The beneficial relationship trend between OMT and sleep quality in patients with a concussion was not statistically significant. Owing to the limitations of this study, further research with a larger population and sham control participants is warranted. (clinicaltrials.gov No. NCT02750566).",2020,"Participants who had an educational intervention (n=14) reported a 36% and 46% improvement from pre-OMT values to their second and third visits, respectively.
","['student athletes with a concussion', 'Student athletes with no medical history of neurodegenerative disease who presented to the New York Institute of Technology College of Osteopathic Medicine Academic Healthcare Center with a concussion following a sport-related injury were enrolled in the study', 'Participants who had an', 'patients with a concussion by improving sleep quality', 'Thirty participants were enrolled in the study', 'Student Athletes']","['osteopathic manipulative treatment (OMT', 'Osteopathic Manipulative Treatment', 'OMT', 'OMT vs concussion education counseling', 'OMT intervention or standard counseling', 'educational intervention']","['Total symptom data', 'OMT and sleep quality', 'pre-OMT values', 'Sleep Quality', 'sleep scores', 'sleep quality', 'mean sleep quality score']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0524851', 'cui_str': 'Neurodegenerative disorder'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0029450', 'cui_str': 'Medicine, Osteopathic'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0949744', 'cui_str': 'Osteopathic manipulation'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0949744', 'cui_str': 'Osteopathic manipulation'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",30.0,0.0422698,"Participants who had an educational intervention (n=14) reported a 36% and 46% improvement from pre-OMT values to their second and third visits, respectively.
","[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Mazzeo', 'Affiliation': ''}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Silverberg', 'Affiliation': ''}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Oommen', 'Affiliation': ''}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Moya', 'Affiliation': ''}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Angelo', 'Affiliation': ''}, {'ForeName': 'Hallie', 'Initials': 'H', 'LastName': 'Zwibel', 'Affiliation': ''}, {'ForeName': 'Jayme', 'Initials': 'J', 'LastName': 'Mancini', 'Affiliation': ''}, {'ForeName': 'Adena', 'Initials': 'A', 'LastName': 'Leder', 'Affiliation': ''}, {'ForeName': 'Sheldon C', 'Initials': 'SC', 'LastName': 'Yao', 'Affiliation': ''}]",The Journal of the American Osteopathic Association,['10.7556/jaoa.2020.100']
2274,32783547,Vitamin D: does it help Tregs in active rheumatoid arthritis patients.,"BACKGROUND


Regulatory T cells (Tregs) play an important role in the maintenance of immunological tolerance, so Tregs deficiency or suppressor functions reduction may be associated with development of autoimmune diseases.  Objectives : To estimate the effect of vitamin D supplementation on the level of Tregs in the peripheral blood of active rheumatoid arthritis (RA) patients.  Methods : 40 patients with active RA were randomly assigned into two groups. Group I received methotrexate (MTX) plus hydroxychloroquine, group II received MTX and hydroxychloroquine plus vitamin D supplementation for 3 months, in addition to 30 healthy volunteers as a control group. Peripheral blood Tregs were measured at baseline and after 3 months by Flow Cytometry.  Results : At baseline, the percentage of Tregs was significantly decreased (p<0.001) in both groups of RA patients (13.52 ±1.95 % and 13.65 ±2.98 % respectively), in comparison to controls (28.44 ±7.37%) with no significant difference between the two patient groups (p=0.866). After 3 months, there was a significant elevation in Tregs percentage in group II compared to group I (p<0.001). Tregs elevation was associated with significant DAS-28 score reduction (p<0.001).  Conclusion : Vitamin D appears to have important immunomodulatory functions. Therefore, vitamin D supplementation can be combined safely with traditional DMARDs to regulate the immune system. Clinical trial registration : Protocol Record 33846, Vitamin D Effect in Rheumatoid Arthritis., http://www.clinicaltrials.gov, identifier is NCT04472481.",2020,"At baseline, the percentage of Tregs was significantly decreased (p<0.001) in both groups of RA patients (13.52 ±1.95 % and 13.65 ±2.98 % respectively), in comparison to controls (28.44 ±7.37%) with no significant difference between the two patient groups (p=0.866).","['active rheumatoid arthritis patients', '40 patients with active RA', 'active rheumatoid arthritis (RA) patients', 'Rheumatoid Arthritis', '30 healthy volunteers as a control group']","['Vitamin D', 'vitamin D supplementation', 'methotrexate (MTX) plus hydroxychloroquine', 'MTX and hydroxychloroquine plus vitamin D supplementation']","['percentage of Tregs', 'Peripheral blood Tregs', 'DAS-28 score reduction']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0051767', 'cui_str': 'amsonic acid'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",30.0,0.223212,"At baseline, the percentage of Tregs was significantly decreased (p<0.001) in both groups of RA patients (13.52 ±1.95 % and 13.65 ±2.98 % respectively), in comparison to controls (28.44 ±7.37%) with no significant difference between the two patient groups (p=0.866).","[{'ForeName': 'Hanaa Samy', 'Initials': 'HS', 'LastName': 'El-Banna', 'Affiliation': 'Faculty of Medicine, Tanta University , Tanta, Egypt.'}, {'ForeName': 'Souzan Ezzat', 'Initials': 'SE', 'LastName': 'Gado', 'Affiliation': 'Faculty of Medicine, Tanta University , Tanta, Egypt.'}]",Expert review of clinical immunology,['10.1080/1744666X.2020.1805317']
2275,32783554,Detection and False-Referral Rates of 2-mSv CT Relative to Standard-Dose CT for Appendiceal Perforation: Pragmatic Multicenter Randomized Controlled Trial.,"OBJECTIVE.  The objective of our study was to compare diagnostic performance of 2-mSv CT and standard-dose CT (SDCT) for the diagnosis of perforated appendicitis in adolescents and young adults.  MATERIALS AND METHODS.  We used the intention-to-treat analysis set of a pragmatic randomized controlled trial involving 3074 patients (age range, 15-44 years) with suspected appendicitis and 161 radiologists from 20 hospitals. The patients were randomized to undergo either 2-mSv CT or SDCT. Predefined endpoints were sensitivity and specificity. Considering potential verification bias caused by the difference in diagnostic interventions (2-mSv CT vs SDCT), we added endpoints of detection rate (DR) and false-referral rate. The reference standards were surgical or pathologic findings. We used Fisher exact tests. Sensitivity analyses included the following: first, a per-protocol analysis; second, an analysis of a surgical reference standard but not a pathologic reference standard; and, third, an analysis to adjust for site clustering. We tested for heterogeneity in DR and false-referral rate across various patient and hospital characteristics.  RESULTS.  The 2-mSv CT and SDCT groups were comparable regarding DR (5.1% [78/1535] vs 4.9% [76/1539]; 95% CI for the difference, -1.4 to 1.7 percentage points;  p  = 0.87), false-referral rate (3.1% [48/1535] vs 3.1% [47/1539]; 95% CI for the difference, -1.2 to 1.3 percentage points;  p  = 0.92), sensitivity (42.9% [78/182] vs 43.2% [76/176]; 95% CI for the difference, -10.6 to 9.9 percentage points;  p  > 0.99), and specificity (89.2% [305/342] vs 91.2% [354/388]; 95% CI for the difference, -6.4 to 2.3 percentage points;  p  = 0.38). Sensitivity analyses showed similar results. We found no significant subgroup heterogeneity.  CONCLUSION.  The performance of 2-mSv CT, with limited sensitivity but high specificity, is comparable to that of SDCT for the diagnosis of appendiceal perforation.",2020,"The performance of 2-mSv CT, with limited sensitivity but high specificity, is comparable to that of SDCT for the diagnosis of appendiceal perforation.","['3074 patients (age range, 15-44 years) with suspected appendicitis and 161 radiologists from 20 hospitals', 'adolescents and young adults']","['2-mSv CT and standard-dose CT (SDCT', 'SDCT', '2-mSv CT or SDCT', '2-mSv CT Relative to Standard-Dose CT']","['diagnostic performance', 'detection rate (DR) and false-referral rate', 'false-referral rate', 'sensitivity', 'specificity', 'sensitivity and specificity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0260194', 'cui_str': 'Radiologist'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0026574', 'cui_str': 'mos Oncogenes'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}]",3074.0,0.282225,"The performance of 2-mSv CT, with limited sensitivity but high specificity, is comparable to that of SDCT for the diagnosis of appendiceal perforation.","[{'ForeName': 'Hae Young', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, Gyeonggi-do, Korea.'}, {'ForeName': 'Yousun', 'Initials': 'Y', 'LastName': 'Ko', 'Affiliation': 'Biomedical Research Center, Asan Institute for Life Sciences, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Ji Hoon', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, Gyeonggi-do, Korea.'}, {'ForeName': 'Kyoung Ho', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, Gyeonggi-do, Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AJR. American journal of roentgenology,['10.2214/AJR.19.22632']
2276,32783585,Small and large cutaneous fibers display different excitability properties to slowly increasing ramp pulses.,"The excitability of large nerve fibers is reduced when their membrane potential is slowly depolarizing, i.e. the fibers display accommodation. The aim of this study was to assess accommodation in small (mainly Aδ) and large (Aβ) cutaneous sensory nerve fibers using the perception threshold tracking (PTT) technique. Linearly increasing ramp currents (1 ms -200 ms) were used to assess the excitability of the nerve fibers by cutaneous electrical stimulation. To investigate the PPT technique's ability to preferentially activate different fiber types, topical application of lidocaine/prilocaine (EMLA) or a placebo cream was applied. By means of computational modelling, the underlying mechanisms governing the perception threshold in the two fiber types was studied. The axon models included the voltage-gated ion channels: Na TTXs , Na TTXr , Na P , K Dr , K M , and HCN. Large fibers displayed accommodation, whereas small fibers did not display accommodation (p<0.05). For the pin electrode, a significant interaction was observed between cream (EMLA or placebo) and pulse duration (p<0.05) whereas for the patch electrode, there was no significant interaction between cream and duration which supports the pin electrode's preferential activation of small fibers. The results from the computational model suggested that differences in accommodation between the two fiber types may originate from selective expression of voltage-gated ion channels, particularly the transient Na TTXr  and/or K Dr . e PTT technique could assess the excitability changes during accommodation in different nerve fibers. Therefore, the PTT technique may be a useful tool for studying excitability in nerve fibers both in healthy as well as in pathological conditions.",2020,"Large fibers displayed accommodation, whereas small fibers did not display accommodation (p<0.05).",[],"['placebo cream', 'lidocaine/prilocaine (EMLA', 'cream (EMLA or placebo', 'perception threshold tracking (PTT) technique']",['excitability changes'],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0617623', 'cui_str': 'Lidocaine- and prilocaine-containing product'}, {'cui': 'C0059079', 'cui_str': 'Eutectic Mixture of Local Anesthetics'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0246953,"Large fibers displayed accommodation, whereas small fibers did not display accommodation (p<0.05).","[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Tigerholm', 'Affiliation': 'Aalborg University, Denmark.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Nielson Hoberg', 'Affiliation': 'Aalborg University, Denmark.'}, {'ForeName': 'Dorthe', 'Initials': 'D', 'LastName': 'Brønnum', 'Affiliation': 'Centre for Clinical Research, North Denmark Regional Hospital, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Vittinghus', 'Affiliation': 'It-center for Telemedicin, Region Midtjylland, Denmark.'}, {'ForeName': 'Ken Steffen', 'Initials': 'KS', 'LastName': 'Frahm', 'Affiliation': 'Aalborg University, Denmark.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Dahl Mørch', 'Affiliation': 'Aalborg University, Denmark.'}]",Journal of neurophysiology,['10.1152/jn.00629.2019']
2277,32783644,Lasmiditan in patients with common migraine comorbidities: a post hoc efficacy and safety analysis of two Phase 3 randomized clinical trials.,"Objective:  Determine whether common migraine comorbidities affect the efficacy and safety of lasmiditan, a 5-HT 1F  receptor agonist approved in the United States for the acute treatment of migraine. Methods:  In SPARTAN and SAMURAI (double-blind Phase 3 clinical trials), patients with migraine were randomized to oral lasmiditan 50 mg (SPARTAN only), 100 mg, 200 mg, or placebo. Lasmiditan increased the proportion of pain-free and most bothersome symptom (MBS)-free patients at 2 hours after dose compared with placebo. Most common treatment-emergent adverse events (TEAEs) were dizziness, paraesthesia, somnolence, fatigue, nausea, muscular weakness, and hypoesthesia. Based upon literature review of common migraine comorbidities, Anxiety, Allergy, Bronchial, Cardiac, Depression, Fatigue, Gastrointestinal, Hormonal, Musculoskeletal/Pain, Neurological, Obesity, Sleep, and Vascular Comorbidity Groups were created. Using pooled results, efficacy and TEAEs were assessed to compare patients with or without a given common migraine comorbidity. To compare treatment groups, p-values were calculated for treatment-by-subgroup interaction, based on logistic regression with treatment-by-comorbidity condition status (Yes/No) as the interaction term; study, treatment group, and comorbidity condition status (Yes/No) were covariates. Differential treatment effect based upon comorbidity status was also examined. Trial registration at clinicaltrials.gov: SAMURAI (NCT02439320) and SPARTAN (NCT02605174). Results:  Across all the Comorbidity Groups, with the potential exception of fatigue, treatment-by-subgroup interaction analyses did not provide evidence of a lasmiditan-driven lasmiditan versus placebo differential treatment effect dependent on Yes versus No comorbidity subgroup for either efficacy or TEAE assessments. Conclusions:  The efficacy and safety of lasmiditan for treatment of individual migraine attacks appear to be independent of comorbid conditions.",2020,Lasmiditan increased the proportion of pain-free and most bothersome symptom (MBS)-free patients at 2 hours after dose compared with placebo.,"['patients with or without a given common migraine comorbidity', 'patients with migraine', 'patients with common migraine comorbidities']","['oral lasmiditan 50\u2009mg (SPARTAN only), 100\u2009mg, 200\u2009mg, or placebo', 'lasmiditan', 'placebo']","['dizziness, paraesthesia, somnolence, fatigue, nausea, muscular weakness, and hypoesthesia', 'proportion of pain-free and most bothersome symptom']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0338480', 'cui_str': 'Migraine without aura'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0151786', 'cui_str': 'Muscle weakness'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.166168,Lasmiditan increased the proportion of pain-free and most bothersome symptom (MBS)-free patients at 2 hours after dose compared with placebo.,"[{'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Clemow', 'Affiliation': 'Eli Lilly and Company, Corporate Center, Indianapolis, IN 46285, USA.'}, {'ForeName': 'Simin K', 'Initials': 'SK', 'LastName': 'Baygani', 'Affiliation': 'Eli Lilly and Company, Corporate Center, Indianapolis, IN 46285, USA.'}, {'ForeName': 'Paula M', 'Initials': 'PM', 'LastName': 'Hauck', 'Affiliation': 'Eli Lilly and Company, Corporate Center, Indianapolis, IN 46285, USA.'}, {'ForeName': 'Cory B', 'Initials': 'CB', 'LastName': 'Hultman', 'Affiliation': 'Eli Lilly and Company, Corporate Center, Indianapolis, IN 46285, USA.'}]",Current medical research and opinion,['10.1080/03007995.2020.1808780']
2278,32784117,Idebenone does not inhibit disability progression in primary progressive MS.,"BACKGROUND


Multiple sclerosis (MS) is a chronic, immune-mediated neurodegenerative disorder of the central nervous system (CNS). While current MS therapies target the inflammatory processes, no treatment explicitly targets mitochondrial dysfunction and resulting axonal loss. Therefore, the aim of this study was to determine whether idebenone inhibits mitochondrial dysfunction and accumulation of disability in primary progressive MS (PPMS) and to enhance understanding of pathogenic mechanisms of PPMS progression using cerebrospinal fluid (CSF) biomarkers.
METHODS


The double-blind, placebo-controlled Phase I/II clinical trial of Idebenone in patients with Primary Progressive MS (IPPoMS; NCT00950248) was an adaptively designed, baseline-versus-treatment, placebo-controlled, CSF-biomarker-supported trial. Based on interim analysis of the 1-year pre-treatment data, change in the area under the curve of Combinatorial Weight-Adjusted Disability Score (CombiWISE) became the primary outcome, with >80% power to detect ≥40% efficacy with 28 patients/arm treated for 2 years in baseline versus treatment paradigm. Changes in traditional disability scales and in brain ventricular volume were secondary outcomes. Exploratory outcomes included CSF biomarkers of mitochondrial dysfunction (Growth/differentiation factor 15 [GDF15] and lactate), axonal damage (neurofilament light chain [NFL]), innate immunity (sCD14), blood brain barrier leakage (albumin quotient) and retinal nerve fiber layer thinning.
RESULTS


Idebenone was well tolerated but did not inhibit disability progression or CNS tissue destruction. Concentrations of GDF15, secreted predominantly by astrocytes and choroid plexus epithelium in vitro, increased after exposure to mitochondrial toxin rotenone, validating the ability of this biomarker to measure intrathecal mitochondrial damage. CSF GDF15 levels correlated strongly with age and MS patients had CSF levels of GDF15 significantly above age-adjusted healthy volunteers, with highest levels measured in PPMS. Idebenone did not change CSF GDF15 levels.
CONCLUSION


Mitochondrial dysfunction exceeding normal aging reflected by age-adjusted CSF GDF15 is present in the majority of PPMS patients, but it is not inhibited by idebenone.",2020,"CSF GDF15 levels correlated strongly with age and MS patients had CSF levels of GDF15 significantly above age-adjusted healthy volunteers, with highest levels measured in PPMS.","['patients with Primary Progressive MS (IPPoMS', 'primary progressive MS (PPMS']","['Idebenone', 'idebenone', 'placebo']","['Mitochondrial dysfunction', 'traditional disability scales', 'CSF levels of GDF15', 'CSF biomarkers of mitochondrial dysfunction (Growth/differentiation factor 15 [GDF15] and lactate), axonal damage (neurofilament light chain [NFL]), innate immunity (sCD14), blood brain barrier leakage (albumin quotient) and retinal nerve fiber layer thinning', 'CSF GDF15 levels', 'Combinatorial Weight-Adjusted Disability Score (CombiWISE', 'disability progression or CNS tissue destruction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751964', 'cui_str': 'Primary progressive multiple sclerosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0123163', 'cui_str': 'idebenone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1431343', 'cui_str': 'GDF15 protein, human'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0020969', 'cui_str': 'Innate Immunity'}, {'cui': 'C0005854', 'cui_str': 'Brain-Blood Barrier'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1261381', 'cui_str': 'Destructive procedure'}]",,0.0721347,"CSF GDF15 levels correlated strongly with age and MS patients had CSF levels of GDF15 significantly above age-adjusted healthy volunteers, with highest levels measured in PPMS.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kosa', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Tianxia', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Clinical trials Unit, National Institute of Neurological Diseases and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Leinonen', 'Affiliation': 'Santhera Pharmaceuticals (Switzerland) AG, Pratteln Switzerland.'}, {'ForeName': 'Ruturaj', 'Initials': 'R', 'LastName': 'Masvekar', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Komori', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Wichman', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Sandford', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bibiana', 'Initials': 'B', 'LastName': 'Bielekova', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA. Electronic address: Bibi.Bielekova@nih.gov.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102434']
2279,32784153,Optimizing Testing for BPPV - The Loaded Dix-Hallpike.,"OBJECTIVES


Although the Dix-Hallpike testing is generally considered as the gold standard for the identification of the posterior canal benign paroxysmal positional vertigo (BPPV), we investigated a modification of the maneuver termed the ""loaded Dix-Hallpike.""
STUDY DESIGN


Prospective randomized controlled trial.
MATERIALS AND METHODS


Twenty-eight patients participated in this prospective study comparing the standard Dix-Hallpike (S-DH) to the loaded Dix-Hallpike (L-DH) test. Each patient underwent repeated testing with the S-DH and the L-DH. The patients were placed into two groups. Fourteen patients underwent 3 rounds of S-DH testing followed by 3 rounds of L-DH testing. The other fourteen patients underwent 3 rounds of L-DH testing followed by 3 rounds of S-DH testing. The duration of nystagmus and the latency prior to the onset of nystagmus were measured for each test. Additionally, the patients were asked to rate the severity of their symptoms following each test.
RESULTS


The duration of nystagmus of the L-DH was significantly longer than that of the S-DH (p<0.0001). The patients reported a higher severity score with L-DH as compared to with S-DH (p<0.001). The L-DH was found to be more sensitive than the S-DH (p=0.0131).
CONCLUSION


The L-DH produces significantly longer duration of nystagmus, stronger symptoms, and improved sensitivity when compared to the S-DH.",2020,"The L-DH was found to be more sensitive than the S-DH (p=0.0131).
","['posterior canal benign paroxysmal positional vertigo (BPPV', 'Twenty-eight patients participated']",['standard Dix-Hallpike (S-DH) to the loaded Dix-Hallpike (L-DH) test'],"['duration of nystagmus of the L-DH', 'duration of nystagmus, stronger symptoms, and improved sensitivity', 'duration of nystagmus and the latency prior to the onset of nystagmus']","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0155502', 'cui_str': 'Benign paroxysmal positional vertigo'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0028738', 'cui_str': 'Nystagmus'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}]",28.0,0.0195251,"The L-DH was found to be more sensitive than the S-DH (p=0.0131).
","[{'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Andera', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Geisinger Medical Center, Pennsylvania, USA.'}, {'ForeName': 'William James', 'Initials': 'WJ', 'LastName': 'Azeredo', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Geisinger Medical Center, Pennsylvania, USA.'}, {'ForeName': 'Joseph Scott', 'Initials': 'JS', 'LastName': 'Greene', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Geisinger Medical Center, Pennsylvania, USA.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Department of Biomedical and Translational Informatics, Geisinger Medical Center, Pennsylvania, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Walter', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Geisinger Medical Center, Pennsylvania, USA.'}]",The journal of international advanced otology,['10.5152/iao.2020.7444']
2280,32784157,The Efficacy of Intratympanic Steroid Injection in Tinnitus Cases Unresponsive to Medical Treatment.,"OBJECTIVES


To examine the efficacy of an intratympanic steroid injection in tinnitus cases unresponsive to medical treatment.
MATERIALS AND METHODS


The study was carried out at the Ear, Nose, and Throat Department with 107 patients (46 male, 61 female) between the ages of 20 and 77 with a mean of 42.8 years who had idiopathic tinnitus. Patients were randomized by simple randomization to receive intratympanic dexamethasone or isotonic solution. The patients received six intratympanic injections, two per week for three weeks. Tinnitus handicap index (THI) was performed before treatment and at first week, first month, and six months after the completion of the study protocol. The audiometric tests were performed six months after the treatment.
RESULT


In the study group, pretreatment THI and post-treatment first month THI scores and pretreatment THI and post-treatment sixth month THI scores were significantly different whereas the same scores were not significantly different in the control group. The comparison of THI scores between the groups revealed significantly lower scores in the first and sixth months for the study group.
CONCLUSION


The effect of the intratympanic injection of dexamethasone on the efficacy of treatment of tinnitus severity was statistically significant.",2020,"The comparison of THI scores between the groups revealed significantly lower scores in the first and sixth months for the study group.
","['Tinnitus Cases Unresponsive to Medical Treatment', 'Ear, Nose, and Throat Department with 107 patients (46 male, 61 female) between the ages of 20 and 77 with a mean of 42.8 years who had idiopathic tinnitus', 'tinnitus cases unresponsive to medical treatment']","['dexamethasone', 'intratympanic steroid injection', 'Intratympanic Steroid Injection', 'intratympanic dexamethasone or isotonic solution']","['THI scores and pretreatment THI and post-treatment sixth month THI scores', 'Tinnitus handicap index (THI', 'THI scores', 'tinnitus severity']","[{'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1517566', 'cui_str': 'Intratympanic route'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}, {'cui': 'C0022260', 'cui_str': 'Isotonic Solutions'}]","[{'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",107.0,0.0149494,"The comparison of THI scores between the groups revealed significantly lower scores in the first and sixth months for the study group.
","[{'ForeName': 'Haydar Murat', 'Initials': 'HM', 'LastName': 'Yener', 'Affiliation': 'Department of Otorhinolaryngology, İstanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, İstanbul, Turkey.'}, {'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Sarı', 'Affiliation': 'Department of Otorhinolaryngology, İstanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, İstanbul, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Aslan', 'Affiliation': 'Department of Otorhinolaryngology, İstanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, İstanbul, Turkey.'}, {'ForeName': 'Umur', 'Initials': 'U', 'LastName': 'Yollu', 'Affiliation': 'Department of Otorhinolaryngology, İstanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, İstanbul, Turkey.'}, {'ForeName': 'Emine Deniz', 'Initials': 'ED', 'LastName': 'Gözen', 'Affiliation': 'Department of Otorhinolaryngology, İstanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, İstanbul, Turkey.'}, {'ForeName': 'Ender', 'Initials': 'E', 'LastName': 'İnci', 'Affiliation': 'Department of Otorhinolaryngology, İstanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, İstanbul, Turkey.'}]",The journal of international advanced otology,['10.5152/iao.2020.7588']
2281,32780643,"Patient-reported outcomes in RELAY, a Phase 3 trial of ramucirumab plus erlotinib versus placebo plus erlotinib in untreated  EGFR -mutated metastatic NSCLC.","Objective :  In the Phase 3 RELAY trial, ramucirumab/erlotinib demonstrated superior progression-free survival (PFS) over placebo/erlotinib in patients with  EGFR -mutated metastatic NSCLC (median PFS 19.4 versus 12.4 months; HR =0.59, 95%CI =0.46-0.76; p < 0.0001). Safety was consistent with established profiles for ramucirumab and erlotinib in NSCLC. Here, we present patient-reported outcomes. Methods :  Patients received oral erlotinib (150 mg daily) plus intravenous ramucirumab (10 mg/kg) or placebo Q2W until progressive disease or unacceptable toxicity. Patients completed the Lung Cancer Symptom Scale (LCSS) and EQ-5D questionnaires at baseline and every other cycle. Analyses included time-to-deterioration (TtD) for LCSS via Kaplan-Meier method and Cox models and changes from baseline using mixed-model repeated-measures regression analysis. Results :  Overall patient compliance for LCSS and EQ-5D was >95%. TtD did not differ between treatment arms for LCSS Total Score (HR =0.962, 95%CI =0.690-1.343) and Average Symptom Burden Index (HR =1.012, 95%CI =0.732-1.400). TtD of individual LCSS items (appetite loss, fatigue, cough, shortness of breath, pain, symptom distress, difficulties with daily activities, quality-of-life) indicated no difference between arms; however, patient-reported blood-in-sputum was worse for ramucirumab/erlotinib (HR =1.987, 95%CI =1.206-3.275). Results of LCSS mean changes from baseline were consistent with TtD, indicating no significant differences between treatment arms except for blood-in-sputum. Mean changes from baseline in EQ-5D index score (p = 0.94) and visual analogue scale (p = 0.95) revealed no overall differences in health status between treatment arms. Conclusions:  Patients' overall quality-of-life and symptom burden did not differ with the addition of ramucirumab to erlotinib as compared to placebo/erlotinib. These data support the clinical benefit of ramucirumab/erlotinib in untreated  EGFR -mutated metastatic NSCLC.",2020,Mean changes from baseline in EQ-5D index score (p = 0.94) and visual analogue scale (p = 0.95) revealed no overall differences in health status between treatment arms.,[],"['placebo/erlotinib', 'ramucirumab/erlotinib', 'placebo Q2W', 'oral erlotinib (150\u2009mg daily) plus intravenous ramucirumab', 'placebo plus erlotinib']","['overall quality-of-life and symptom burden', 'superior progression-free survival (PFS', 'Overall patient compliance for LCSS and EQ-5D', 'LCSS Total Score', 'visual analogue scale', 'TtD of individual LCSS items (appetite loss, fatigue, cough, shortness of breath, pain, symptom distress, difficulties with daily activities, quality-of-life', 'blood-in-sputum', 'health status', 'Lung Cancer Symptom Scale (LCSS) and EQ-5D questionnaires', 'time-to-deterioration (TtD) for LCSS via Kaplan-Meier method and Cox models', 'Average Symptom Burden Index', 'EQ-5D index score', 'LCSS mean changes']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0012772', 'cui_str': 'Disulfiram'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0010234', 'cui_str': 'Cox Models'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.423814,Mean changes from baseline in EQ-5D index score (p = 0.94) and visual analogue scale (p = 0.95) revealed no overall differences in health status between treatment arms.,"[{'ForeName': 'Kiyotaka', 'Initials': 'K', 'LastName': 'Yoh', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Atagi', 'Affiliation': 'National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Lungen Clinic, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Garon', 'Affiliation': 'David Geffen School of Medicine at University of California Los Angeles/TRIO-US Network, Los Angeles, CA, USA.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Ponce Aix', 'Affiliation': 'Hospital Universitario 12 de Octubre, H12O-CNIO Lung Cancer Clinical Research Unit, Universidad Complutense & Ciberonc, Madrid, Spain.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Moro-Sibilot', 'Affiliation': 'Grenoble University Hospital, Grenoble, France.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Winfree', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Frimodt-Moller', 'Affiliation': 'Eli Lilly and Company, Copenhagen, Denmark.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Zimmermann', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Visseren-Grul', 'Affiliation': 'Lilly Oncology, Utrecht, Netherlands.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Current medical research and opinion,['10.1080/03007995.2020.1808781']
2282,32780660,Brigatinib Versus Crizotinib in Advanced ALK Inhibitor-Naive ALK-Positive Non-Small Cell Lung Cancer: Second Interim Analysis of the Phase III ALTA-1L Trial.,"PURPOSE


Brigatinib, a next-generation anaplastic lymphoma kinase (ALK) inhibitor, demonstrated superior progression-free survival (PFS) and improved health-related quality of life (QoL) versus crizotinib in advanced ALK inhibitor-naive ALK-positive non-small cell lung cancer (NSCLC) at first interim analysis (99 events; median brigatinib follow-up, 11.0 months) in the open-label, phase III ALTA-1L trial (ClinicalTrials.gov identifier: NCT02737501). We report results of the second prespecified interim analysis (150 events).
METHODS


Patients with ALK inhibitor-naive advanced ALK-positive NSCLC were randomly assigned 1:1 to brigatinib 180 mg once daily (7-day lead-in at 90 mg once daily) or crizotinib 250 mg twice daily. The primary end point was PFS as assessed by blinded independent review committee (BIRC). Investigator-assessed efficacy, blood samples for pharmacokinetic assessments, and patient-reported outcomes were also collected.
RESULTS


Two hundred seventy-five patients were randomly assigned (brigatinib, n = 137; crizotinib, n = 138). With median follow-up of 24.9 months for brigatinib (150 PFS events), brigatinib showed consistent superiority in BIRC-assessed PFS versus crizotinib (hazard ratio [HR], 0.49 [95% CI, 0.35 to 0.68]; log-rank  P  < .0001; median, 24.0  v  11.0 months). Investigator-assessed PFS HR was 0.43 (95% CI, 0.31 to 0.61; median, 29.4  v  9.2 months). No new safety concerns emerged. Brigatinib delayed median time to worsening of global health status/QoL scores compared with crizotinib (HR, 0.70 [95% CI, 0.49 to 1.00]; log-rank  P  = .049). Brigatinib daily area under the plasma concentration-time curve was not a predictor of PFS (HR, 1.005 [95% CI, 0.98 to 1.031];  P  = .69).
CONCLUSION


Brigatinib represents a once-daily ALK inhibitor with superior efficacy, tolerability, and QoL over crizotinib, making it a promising first-line treatment of ALK-positive NSCLC.",2020,"Brigatinib delayed median time to worsening of global health status/QoL scores compared with crizotinib (HR, 0.70 [95% CI, 0.49 to 1.00]; log-rank  P  = .049).","['Patients with ALK inhibitor-naive advanced ALK-positive NSCLC', 'Two hundred seventy-five patients were randomly assigned (brigatinib, n = 137; crizotinib, n = 138', 'Non-Small Cell Lung Cancer']","['brigatinib 180 mg once daily (7-day lead-in at 90 mg once daily) or crizotinib 250 mg twice daily', 'Brigatinib Versus Crizotinib in Advanced ALK Inhibitor-Naive ALK-Positive']","['Brigatinib delayed median time to worsening of global health status/QoL scores', 'superior progression-free survival (PFS) and improved health-related quality of life (QoL', 'Brigatinib daily area under the plasma concentration-time curve']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0252409', 'cui_str': 'ALK Tyrosine Kinase Receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4287815', 'cui_str': 'brigatinib'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C2974289', 'cui_str': 'crizotinib'}]","[{'cui': 'C4530661', 'cui_str': 'brigatinib 180 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C3204577', 'cui_str': 'crizotinib 250 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C4287815', 'cui_str': 'brigatinib'}, {'cui': 'C2974289', 'cui_str': 'crizotinib'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0252409', 'cui_str': 'ALK Tyrosine Kinase Receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]","[{'cui': 'C4287815', 'cui_str': 'brigatinib'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",275.0,0.347815,"Brigatinib delayed median time to worsening of global health status/QoL scores compared with crizotinib (HR, 0.70 [95% CI, 0.49 to 1.00]; log-rank  P  = .049).","[{'ForeName': 'D Ross', 'Initials': 'DR', 'LastName': 'Camidge', 'Affiliation': 'University of Colorado Cancer Center, Aurora, CO.'}, {'ForeName': 'Hye Ryun', 'Initials': 'HR', 'LastName': 'Kim', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Myung-Ju', 'Initials': 'MJ', 'LastName': 'Ahn', 'Affiliation': 'Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'James C H', 'Initials': 'JCH', 'LastName': 'Yang', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ji-Youn', 'Initials': 'JY', 'LastName': 'Han', 'Affiliation': 'National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Maximilian J', 'Initials': 'MJ', 'LastName': 'Hochmair', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Krankenhaus Nord-Klinik Floridsdorf, Vienna, Austria.'}, {'ForeName': 'Ki Hyeong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Chungbuk National University Hospital, Cheongju, South Korea.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Delmonte', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), IRCCS, Meldola, Italy.'}, {'ForeName': 'Maria Rosario', 'Initials': 'MR', 'LastName': 'García Campelo', 'Affiliation': 'Complejo Hospitalario Universitario A Coruna, Coruna, Spain.'}, {'ForeName': 'Dong-Wan', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Griesinger', 'Affiliation': 'Pius-Hospital Oldenburg, University of Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Enriqueta', 'Initials': 'E', 'LastName': 'Felip', 'Affiliation': ""Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Califano', 'Affiliation': 'The Christie NHS Foundation Trust and Division of Cancer Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Spira', 'Affiliation': 'Virginia Cancer Specialists and US Oncology Research, The Woodlands, TX.'}, {'ForeName': 'Scott N', 'Initials': 'SN', 'LastName': 'Gettinger', 'Affiliation': 'Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Tiseo', 'Affiliation': 'University Hospital of Parma, Parma, Italy.'}, {'ForeName': 'Huamao M', 'Initials': 'HM', 'LastName': 'Lin', 'Affiliation': 'Millennium Pharmaceuticals, Cambridge, MA.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'Millennium Pharmaceuticals, Cambridge, MA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hanley', 'Affiliation': 'Millennium Pharmaceuticals, Cambridge, MA.'}, {'ForeName': 'Quanhong', 'Initials': 'Q', 'LastName': 'Ni', 'Affiliation': 'Millennium Pharmaceuticals, Cambridge, MA.'}, {'ForeName': 'Pingkuan', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Millennium Pharmaceuticals, Cambridge, MA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Popat', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00505']
2283,32780661,"Hypofractionated Versus Conventional Fractionated Radiotherapy After Breast-Conserving Surgery in the Modern Treatment Era: A Multicenter, Randomized Controlled Trial From China.","PURPOSE


No randomized trials have compared hypofractionated radiotherapy (HFRT) with conventional fractionated radiotherapy (CFRT) after breast-conserving surgery in the Asian population. This study aimed to determine whether a 3.5-week schedule of HFRT is noninferior to a standard 6-week schedule of CFRT in China.
PATIENTS AND METHODS


Patients from 4 Chinese institutions who had undergone breast-conserving surgery and had T1-2N0-3 invasive breast cancers participated this study. Patients were randomly assigned (1:1) using a computer-generated central randomization schedule, without stratification, to receive whole-breast irradiation with or without nodal irradiation, followed by tumor-bed boost, either at a dose of 50 Gy in 25 fractions over 5 weeks with a boost of 10 Gy in five fractions over 1 week (CFRT) or 43.5 Gy in 15 fractions over 3 weeks with a boost of 8.7 Gy in three daily fractions (HFRT). The primary endpoint was 5-year local recurrence (LR), and a 5% margin of 5-year LR was used to establish noninferiority.
RESULTS


Between August 2010 and November 2015, 734 patients were assigned to the HFRT (n = 368) or CFRT (n = 366) group. At a median follow-up of 73.5 months (interquartile range, 60.5-91.4 months), the 5-year cumulative incidence of LR was 1.2% in the HFRT group and 2.0% in the CFRT group (hazard ratio, 0.62; 95% CI, 0.20 to 1.88;  P  = .017 for noninferiority). There were no significant differences in acute and late toxicities, except that the HFRT group had less grade 2-3 acute skin toxicity than the CFRT group ( P  = .019).
CONCLUSION


CFRT and HFRT with a tumor-bed boost may have similar low LR and toxicity.",2020,"There were no significant differences in acute and late toxicities, except that the HFRT group had less grade 2-3 acute skin toxicity than the CFRT group ( P  = .019).
","['734 patients were assigned to the', 'Between August 2010 and November 2015', 'After Breast-Conserving Surgery in the Modern Treatment Era', 'breast-conserving surgery in the Asian population', 'Patients from 4 Chinese institutions who had undergone breast-conserving surgery and had T1-2N0-3 invasive breast cancers participated this study']","['Hypofractionated Versus Conventional Fractionated Radiotherapy', 'CFRT', 'hypofractionated radiotherapy (HFRT) with conventional fractionated radiotherapy (CFRT', 'HFRT', 'computer-generated central randomization schedule, without stratification, to receive whole-breast irradiation with or without nodal irradiation']","['5-year local recurrence (LR), and a 5% margin of 5-year LR', 'grade 2-3 acute skin toxicity', 'acute and late toxicities', 'low LR and toxicity', '5-year cumulative incidence of LR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",734.0,0.283661,"There were no significant differences in acute and late toxicities, except that the HFRT group had less grade 2-3 acute skin toxicity than the CFRT group ( P  = .019).
","[{'ForeName': 'Shu-Lian', 'Initials': 'SL', 'LastName': 'Wang', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Yong-Wen', 'Initials': 'YW', 'LastName': 'Song', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Wei-Hu', 'Initials': 'WH', 'LastName': 'Wang', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Yue-Ping', 'Initials': 'YP', 'LastName': 'Liu', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Radiation Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Gao-Feng', 'Initials': 'GF', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, Beijing Hospital, Beijing, China.'}, {'ForeName': 'Xiang-Hui', 'Initials': 'XH', 'LastName': 'Du', 'Affiliation': 'Department of Radiation Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Jing', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Yu-Chao', 'Initials': 'YC', 'LastName': 'Ma', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Ning-Ning', 'Initials': 'NN', 'LastName': 'Lu', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Shu-Nan', 'Initials': 'SN', 'LastName': 'Qi', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Guang-Yi', 'Initials': 'GY', 'LastName': 'Sun', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Xin-Fan', 'Initials': 'XF', 'LastName': 'Liu', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Ye-Xiong', 'Initials': 'YX', 'LastName': 'Li', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01024']
2284,32780676,Applying a social-ecological lens to opinions about HIV self-testing among Kenyan truckers who declined to test: a qualitative study.,"HIV prevalence among truckers in Africa is high and testing rates suboptimal. With numerous African countries having approved HIV self-testing kits, more information on how to design acceptable and accessible self-testing programs for high-risk populations is necessary. We explored views about self-testing via in-depth interviews with 24 truckers participating in a randomised controlled trial who refused HIV testing. A social-ecological lens was used to guide data analysis and frame study findings. While most participants said that they would use an HIV self-test, perceived barriers and facilitators were identified at multiple levels. Many participants noted lack of time to test or obtain a self-test kit as a major barrier (intrapersonal) and varied in their views about self-testing with a partner (interpersonal). Participants offered programmatic/policy recommendations, suggesting that they preferred accessing self-test kits in settings where training could be provided. Participants believed they should be able to pick up multiple test kits at the same time and that the test kits should be free or low cost. These study findings will help guide the design of self-testing programs for truckers and other mobile populations.",2020,"While most participants said that they would use an HIV self-test, perceived barriers and facilitators were identified at multiple levels.",['24 truckers participating in a randomised controlled trial who refused HIV testing'],[],[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}]",[],[],,0.0241349,"While most participants said that they would use an HIV self-test, perceived barriers and facilitators were identified at multiple levels.","[{'ForeName': 'Stephanie N', 'Initials': 'SN', 'LastName': 'Christian', 'Affiliation': 'Department of Community Health and Social Sciences, CUNY Graduate School of Public Health and Health Policy, City University of New York, New York, USA.'}, {'ForeName': 'Joanne E', 'Initials': 'JE', 'LastName': 'Mantell', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Department of Psychiatry, Division of Gender, Sexuality and Health, New York State Psychiatric Institute & Columbia University, New York, USA.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Romo', 'Affiliation': 'Department of Epidemiology and Biostatistics, CUNY Graduate School of Public Health and Health Policy, City University of New York, New York, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grov', 'Affiliation': 'Department of Community Health and Social Sciences, CUNY Graduate School of Public Health and Health Policy, City University of New York, New York, USA.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'George', 'Affiliation': 'Health Economics and HIV and AIDS Research Division, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Mwai', 'Affiliation': 'North Star Alliance, Nairobi, Kenya.'}, {'ForeName': 'Eston', 'Initials': 'E', 'LastName': 'Nyaga', 'Affiliation': 'North Star Alliance, Nairobi, Kenya.'}, {'ForeName': 'Jacob O', 'Initials': 'JO', 'LastName': 'Odhiambo', 'Affiliation': 'North Star Alliance, Nairobi, Kenya.'}, {'ForeName': 'Kaymarlin', 'Initials': 'K', 'LastName': 'Govender', 'Affiliation': 'Health Economics and HIV and AIDS Research Division, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Kelvin', 'Affiliation': 'Department of Community Health and Social Sciences, CUNY Graduate School of Public Health and Health Policy, City University of New York, New York, USA.'}]",African journal of AIDS research : AJAR,['10.2989/16085906.2020.1764070']
2285,32780739,"The effect of an airflow restriction mask (ARM) on metabolic, ventilatory, and electromyographic responses to continuous cycling exercise.","This study analyzed the physiological adjustments caused by the use of the Elevation training mask® (2.0), an airflow restriction mask (ARM) during continuous exercise. Eighteen physically active participants (12 men and 6 women) were randomized to two protocols: continuous exercise with mask (CE-ARM) and continuous exercise without mask (CE). Exercise consisted of cycling for 20 minutes at 60% of maximum power. Metabolic variables, lactate, and gas concentration were obtained from arterialized blood samples at pre and post exercise. Continuous expired gases and myoelectric activity of the quadriceps were performed at rest and during the test. We observed no reduction in oxygen saturation in CE-ARM, leading to lower pH, higher carbon dioxide, and greater hematocrit (all p <0.05). The expired gas analysis shows that the CE-ARM condition presented higher oxygen uptake and expired carbon dioxide concentrations (p <0.05). The CE-ARM condition also presented lower ventilatory volume, ventilatory frequency, and expired oxygen pressure (p <0.05). No changes in electromyography activity and lactate concentrations were identified. We conclude that using ARM does not induce hypoxia and represents an additional challenge for the control of acid-base balance, and we suggest the use of ARM as being suitable for respiratory muscle training.",2020,No changes in electromyography activity and lactate concentrations were identified.,['Eighteen physically active participants (12 men and 6 women'],"['airflow restriction mask (ARM', 'Elevation training mask® (2.0), an airflow restriction mask (ARM', 'continuous exercise with mask (CE-ARM) and continuous exercise without mask (CE', 'continuous cycling exercise']","['metabolic, ventilatory, and electromyographic responses', 'Metabolic variables, lactate, and gas concentration', 'electromyography activity and lactate concentrations', 'oxygen saturation in CE-ARM, leading to lower pH, higher carbon dioxide, and greater hematocrit', 'oxygen uptake and expired carbon dioxide concentrations', 'ventilatory volume, ventilatory frequency, and expired oxygen pressure']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0728725', 'cui_str': 'Low pH'}, {'cui': 'C0860713', 'cui_str': 'Carbon dioxide increased'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0428653', 'cui_str': 'Carbon dioxide concentration'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",18.0,0.0240789,No changes in electromyography activity and lactate concentrations were identified.,"[{'ForeName': 'João Francisco', 'Initials': 'JF', 'LastName': 'Barbieri', 'Affiliation': 'Department of Sport Science, School of Physical Education, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Arthur Fernandes', 'Initials': 'AF', 'LastName': 'Gáspari', 'Affiliation': 'Department of Sport Science, School of Physical Education, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Cassia Lopes', 'Initials': 'CL', 'LastName': 'Teodoro', 'Affiliation': 'Department of Sport Science, School of Physical Education, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Motta', 'Affiliation': 'Department of Sport Science, School of Physical Education, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Luz Albany Arcila', 'Initials': 'LAA', 'LastName': 'Castaño', 'Affiliation': 'Department of Sport Science, School of Physical Education, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Romulo', 'Initials': 'R', 'LastName': 'Bertuzzi', 'Affiliation': 'Endurance Performance Research (GEDAE-USP), School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Celene Fernandes', 'Initials': 'CF', 'LastName': 'Bernades', 'Affiliation': 'Department of Sport Science, School of Physical Education, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Mara Patrícia Traina', 'Initials': 'MPT', 'LastName': 'Chacon-Mikahil', 'Affiliation': 'Department of Sport Science, School of Physical Education, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Antonio Carlos', 'Initials': 'AC', 'LastName': 'de Moraes', 'Affiliation': 'Department of Sport Science, School of Physical Education, University of Campinas, Campinas, Brazil.'}]",PloS one,['10.1371/journal.pone.0237010']
2286,32780981,The feasibility of an 8-Week walking training program using a novel assistive gait training device in individuals with spinal cord injury.,"PURPOSE


The objective of this study was to examine the feasibility of an 8-week walking training programme using a novel assistive gait training device in individuals with chronic spinal cord injury (SCI).
METHODS


This study was a pilot, single group, pretest-posttest study design. Participants received walking training, 3 sessions a week for 8 weeks. Participants were trained on a treadmill using a novel assistive gait training device. Feasibility data about recruitment, retention, compliance, and participants' performance, and participants' perception were collected throughout the study period.
RESULTS


11 participants with chronic SCI (8 males, 3 females, age: 38 ± 10 years old, injury levels T3-L1; injury onset 8 ± 10 years) completed the study. The recruitment rate of 27.2% reached in this study was acceptable. Throughout the period of training, all participants were able to progress in their walking performance with respect to treadmill speed, walking distance, duration of training, and percentage of body weight support. The overall compliance rate of participants with training sessions was 96.2 ± 6.5%. From responses to the end intervention questionnaire, the majority of participants showed positive perception to the walking training programme as well as the assistive gait training.
CONCLUSION


The 8 weeks of walking training was feasible in individuals with chronic SCI. The assistive gait training device was feasible and safe to use in individuals with paraplegia.  Clinical Trials Registration Number:  NCT03940274 Implication for rehabilitation The use of a novel assistive gait training device using a pulley system with a pulling cable walking training is feasible. The novel assistive gait training device will reduce workload by allowing physical therapists to work on an ergonomic position while providing the necessary stepping assistance for the patient's legs/feet during walking on a treadmill. The novel assistive gait training device is developed to provide a low-cost assistive device to be used in walking rehabilitation for people with spinal cord injury.",2020,"Throughout the period of training, all participants were able to progress in their walking performance with respect to treadmill speed, walking distance, duration of training, and percentage of body weight support.","['individuals with chronic spinal cord injury (SCI', '11 participants with chronic SCI (8 males, 3 females, age: 38\u2009±\u200910\u2009years old, injury levels T3-L1; injury onset 8\u2009±\u200910\u2009years) completed the study', 'individuals with spinal cord injury', 'people with spinal cord injury', 'individuals with chronic SCI', 'individuals with paraplegia']","['novel assistive gait training device using a pulley system with a pulling cable walking training', 'walking training', 'rehabilitation', 'assistive gait training device', 'novel assistive gait training device', '8-week walking training programme', '8-Week walking training program']",['overall compliance rate'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0446421', 'cui_str': 'Level of the third thoracic vertebra'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030486', 'cui_str': 'Paraplegia'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C1298904', 'cui_str': 'Device used'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",11.0,0.0284938,"Throughout the period of training, all participants were able to progress in their walking performance with respect to treadmill speed, walking distance, duration of training, and percentage of body weight support.","[{'ForeName': 'Ramzi A', 'Initials': 'RA', 'LastName': 'Alajam', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Abdulfattah S', 'Initials': 'AS', 'LastName': 'Alqahtanti', 'Affiliation': 'Department of Rehabilitation Health, King Saud University, Riyadh, Saud Arabia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Frederick', 'Affiliation': 'Department of and Rehabilitation Medicine, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, USA.'}]",Disability and rehabilitation. Assistive technology,['10.1080/17483107.2020.1805801']
2287,32780994,"Does Combined Low-Level Laser and Light-Emitting Diode Light Irradiation Reduce Pain, Swelling, and Trismus After Surgical Extraction of Mandibular Third Molars? A Randomized Double-Blinded Crossover Study.","PURPOSE


Complications after extraction of mandibular third molars, including pain, swelling, and trismus, are common problematic phenomena for both patients and surgeons. The main objective of the present study was to evaluate the therapeutic effect of combined low-level laser (LLL) and light-emitting diode (LED) irradiation on the recovery rate of such complications.
PATIENTS AND METHODS


The authors implemented a prospective randomized, double-blind crossover design. Forty participants (80 teeth) were enrolled, each with bilateral and symmetrical impacted lower third molars. Participants had lower third molars extracted at 2 separate visits. Participants were randomized to receive LLL plus LED or placebo at the initial surgical procedure. Participants acted as their control during the second surgical procedure. The primary predictor variable was LLL plus LED. The primary outcome variable was pain measured at postoperative days 3 and 7. Secondary outcome variables were swelling and trismus. The Mann-Whitney U, Wilcoxon, and Friedman tests were used for statistical analysis with a P < .05 considered significant.
RESULTS


The sample size of each group was 40 (male to female ratio of 1:1, mean age 24.8 ± 3.9). Preoperative scores of all scales were lower for both groups compared with days 3 and 7 (P < .0001). Postoperative pain levels on days 3 and 7 were significantly less in the intervention group (P = .03 and P = .01, respectively). Compared with the control group, the postoperative trismus level of the intervention group was significantly less on day 3 (P = .006). However, the difference on day 7 was not significant. Postoperative swelling levels on days 3 and 7 were significantly less in the intervention group (P < .0001).
CONCLUSIONS


Combined LLL plus LED irradiation could be an effective therapy to decrease postoperative pain and swelling after impacted third molar extractions.",2020,Preoperative scores of all scales were lower for both groups compared with days 3 and 7 (P < .0001).,"['Participants had lower third molars extracted at 2 separate visits', 'Forty participants (80 teeth) were enrolled, each with bilateral and symmetrical impacted lower third molars', 'sample size of each group was 40 (male to female ratio of 1:1, mean age 24.8\xa0±\xa03.9']","['Combined Low-Level Laser and Light-Emitting Diode Light Irradiation', 'combined low-level laser (LLL) and light-emitting diode (LED) irradiation', 'LLL plus LED irradiation', 'LLL plus LED or placebo']","['postoperative trismus level', 'LLL plus LED', 'Postoperative pain levels', 'Postoperative swelling levels', 'pain, swelling, and trismus', 'Preoperative scores of all scales', 'Pain, Swelling, and Trismus', 'pain', 'swelling and trismus', 'postoperative pain and swelling']","[{'cui': 'C0227191', 'cui_str': 'Structure of lower third of esophagus'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517698', 'cui_str': '3.9'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",40.0,0.516449,Preoperative scores of all scales were lower for both groups compared with days 3 and 7 (P < .0001).,"[{'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Mohajerani', 'Affiliation': 'Full Professor, Deputy of Oral and Maxillofacial Surgery, Dental School, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Faraj', 'Initials': 'F', 'LastName': 'Tabeie', 'Affiliation': 'Associate Professor, Department of Basic Sciences, School of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Alirezaei', 'Affiliation': 'Student, Dental Research Center, Research Institute of Dental Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ghazaleh', 'Initials': 'G', 'LastName': 'Keyvani', 'Affiliation': 'Student, Dental Research Center, Research Institute of Dental Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Bemanali', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Dental School, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: m.bemanali@sbmu.ac.ir.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.07.017']
2288,32780999,"Prospective Randomized Double-Blind, Placebo Controlled Evaluation of the Pharmacokinetics, Safety and Efficacy of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia (PRESERVE-1).","BACKGROUND


Despite expectant management, preeclampsia remote from term usually results in preterm delivery. Antithrombin displays anti-inflammatory and anticoagulant properties and thus may have a therapeutic role treating preterm preeclampsia, a disorder characterized by endothelial dysfunction, inflammation and activation of the coagulation system.
STUDY DESIGN AND OBJECTIVES


We performed a double-blind, placebo-controlled trial at 23 hospitals. Women were eligible if they had a singleton pregnancy, early onset or superimposed preeclampsia at 23 0/7 to 30 0/7 weeks, and expectant management was planned. In addition to standard therapy, patients were randomized to receive either recombinant antithrombin 250 mg loading dose followed by a continuous infusion 2000mg/24hours or an identical saline infusion until delivery. The primary outcome was days gained from randomization until delivery. Secondary outcome was composite neonatal morbidity score. 120 women were randomized.
RESULTS


There was no difference in median gestational age at enrollment (27.3 weeks for the recombinant antithrombin group [range 23.1-30.0] and 27.6 weeks for the placebo group, [range 23.0-30.0], respectively, p value 0.67. There were no differences in median increase in days gained (5.0 in the recombinant antithrombin group [range 0-75] and 6.0 for the placebo group [range 0-85], p value 0.95). There were no differences between groups in composite neonatal morbidity scores or in maternal complications. No safety issues related to recombinant human antithrombin were noted in this study, despite the achievement of supraphysiologic antithrombin concentrations.
CONCLUSIONS


Administration of recombinant antithrombin in preterm preeclampsia was not associated with pregnancy prolongation, nor in improved neonatal or maternal outcomes.",2020,There were no differences between groups in composite neonatal morbidity scores or in maternal complications.,"['120 women were randomized', 'Preterm Preeclampsia (PRESERVE-1', '23 hospitals', 'Women were eligible if they had a singleton pregnancy, early onset or superimposed preeclampsia at 23 0/7 to 30 0/7 weeks, and expectant management was planned']","['Placebo', 'Antithrombin', 'recombinant antithrombin', 'Recombinant Antithrombin Versus Placebo', 'placebo']","['composite neonatal morbidity score', 'median gestational age', 'composite neonatal morbidity scores', 'neonatal or maternal outcomes', 'days gained from randomization until delivery', 'median increase in days gained']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003438', 'cui_str': 'Antithrombin III'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",120.0,0.711927,There were no differences between groups in composite neonatal morbidity scores or in maternal complications.,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Paidas', 'Affiliation': 'Yale University School of Medicine. Electronic address: mxp1440@med.miami.edu.'}, {'ForeName': 'Allan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': 'University of Alabama at Birmingham School of Medicine.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': 'Washington University School of Medicine.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Saade', 'Affiliation': 'University of Texas Medical Branch.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Ehrenkranz', 'Affiliation': 'Yale University School of Medicine.'}, {'ForeName': 'Elizabeth W', 'Initials': 'EW', 'LastName': 'Triche', 'Affiliation': 'Brown University School of Medicine.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Streisand', 'Affiliation': 'rEVO Biologics, LFB USA.'}, {'ForeName': 'Garrett K', 'Initials': 'GK', 'LastName': 'Lam', 'Affiliation': 'University of Tennessee College of Medicine.'}, {'ForeName': 'Everett F', 'Initials': 'EF', 'LastName': 'Magann', 'Affiliation': 'University of Arkansas for Medical Sciences.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Lewis', 'Affiliation': ""University of South Alabama Children's and Women's Hospital.""}, {'ForeName': 'Mitchell P', 'Initials': 'MP', 'LastName': 'Dombrowski', 'Affiliation': 'St. John Hospital and Medical Center.'}, {'ForeName': 'Erika F', 'Initials': 'EF', 'LastName': 'Werner', 'Affiliation': 'Women and Infants Hospital of Rhode Island.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Branch', 'Affiliation': 'University of Utah Health.'}, {'ForeName': 'Mounira A', 'Initials': 'MA', 'LastName': 'Habli', 'Affiliation': ""Cincinnati Children's Hospital.""}, {'ForeName': 'Chad A', 'Initials': 'CA', 'LastName': 'Grotegut', 'Affiliation': 'Duke University Health System.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'University of Utah.'}, {'ForeName': 'Sherri A', 'Initials': 'SA', 'LastName': 'Longo', 'Affiliation': 'Ochsner Clinic Foundation.'}, {'ForeName': 'Erol', 'Initials': 'E', 'LastName': 'Amon', 'Affiliation': 'St. Louis University School of Medicine.'}, {'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Cleary', 'Affiliation': 'Columbia University Irving Medical Center.'}, {'ForeName': 'Helen Y', 'Initials': 'HY', 'LastName': 'How', 'Affiliation': 'Norton Healthcare.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Novotny', 'Affiliation': 'University of Mississippi Medical Center.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': 'Northwestern University School of Medicine.'}, {'ForeName': 'Valerie E', 'Initials': 'VE', 'LastName': 'Whiteman', 'Affiliation': 'University of South Florida.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Wing', 'Affiliation': 'University of California Irvine.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Scifres', 'Affiliation': 'University of Oklahoma Health Sciences Center.'}, {'ForeName': 'Baha M', 'Initials': 'BM', 'LastName': 'Sibai', 'Affiliation': 'University of Texas Health Sciences Center at Houston.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.08.004']
2289,32781050,"Systemic Inflammation, Vascular Function and Endothelial Progenitor Cells after an Exercise Training Intervention in COPD.","BACKGROUND


Exercise training is a cornerstone of the treatment of COPD in all disease stages. Data about the training effects with supplemental oxygen in non-hypoxemic patients remains inconclusive. In this study we set out to investigate the training and oxygen effects on inflammatory markers, vascular function and endothelial progenitor cells in this population of increased cardiovascular risk.
METHODS


In this prospective, randomized, double-blind, crossover study, 29 patients with non-hypoxemic COPD performed combined endurance and strength training three times a week while breathing medical air or supplemental oxygen for the first six-week period, to be then reallocated to the opposite gas for the following six weeks. Exercise capacity, inflammatory biomarkers, endothelial function (Peripheral Arterial Tone analysis) and endothelial progenitor cells were assessed. Data were also analyzed for a subgroup with endothelial dysfunction (Reactive Hyperemia Index (RHI) < 1.67).
RESULTS


Following 12 weeks of exercise training, patients demonstrated a significant improvement of peak work rate and an associated decrease of blood fibrinogen and leptin. Eosinophils were found significantly reduced after exercise training in patients with endothelial dysfunction. In this subgroup, peripheral arterial tone analysis revealed a significant improvement of RHI. Generally, late endothelial progenitor cells were found significantly reduced after the exercise training intervention. Supplemental oxygen during training positively influenced the effect on exercise capacity without impact on inflammation and endothelial function.
CONCLUSIONS


This is the first randomized controlled trial in patients with COPD to show beneficial effects of exercise training not only on exercise capacity, but also on systemic/eosinophilic inflammation and endothelial dysfunction.",2020,"Following 12 weeks of exercise training, patients demonstrated a significant improvement of peak work rate and an associated decrease of blood fibrinogen and leptin.","['29 patients with non-hypoxemic COPD performed', 'patients with COPD', 'patients with endothelial dysfunction']","['combined endurance and strength training three times a week while breathing medical air or supplemental oxygen', 'Exercise Training Intervention', 'Exercise training', 'exercise training']","['inflammatory markers, vascular function and endothelial progenitor cells', 'Eosinophils', 'blood fibrinogen and leptin', 'peak work rate', 'Exercise capacity, inflammatory biomarkers, endothelial function (Peripheral Arterial Tone analysis) and endothelial progenitor cells', 'RHI', 'Systemic Inflammation, Vascular Function and Endothelial Progenitor Cells', 'systemic/eosinophilic inflammation and endothelial dysfunction', 'endothelial dysfunction (Reactive Hyperemia Index', 'late endothelial progenitor cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C3536832', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0853182', 'cui_str': 'Blood fibrinogen'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C3687252', 'cui_str': 'Eosinophilic inflammation'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205087', 'cui_str': 'Late'}]",29.0,0.115684,"Following 12 weeks of exercise training, patients demonstrated a significant improvement of peak work rate and an associated decrease of blood fibrinogen and leptin.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Neunhäuserer', 'Affiliation': 'University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University of Salzburg, Lindhofstraße 20, 5020 Salzburg, Austria; Research Institute for Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University of Salzburg, Lindhofstraße 20, 5020 Salzburg, Austria; Sport and Exercise Medicine Division, Department of Medicine, University of Padova, Via Giustiniani 2, 35128 Padova, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Patti', 'Affiliation': 'Sport and Exercise Medicine Division, Department of Medicine, University of Padova, Via Giustiniani 2, 35128 Padova, Italy.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Niederseer', 'Affiliation': 'University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University of Salzburg, Lindhofstraße 20, 5020 Salzburg, Austria; Research Institute for Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University of Salzburg, Lindhofstraße 20, 5020 Salzburg, Austria; Division of Cardiology, University Heart Centre, University Hospital Zurich, Rämistraße 100, 8091 Zurich, Switzerland.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Kaiser', 'Affiliation': 'University Clinic of Pneumology, Paracelsus Medical University of Salzburg, Müllner Hauptstraße 48, 5020 Salzburg, Austria.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Cadamuro', 'Affiliation': 'Department of Laboratory Medicine, Paracelsus Medical University of Salzburg, Müllner Hauptstraße 48, 5020 Salzburg, Austria.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Lamprecht', 'Affiliation': 'University Clinic of Pneumology, Paracelsus Medical University of Salzburg, Müllner Hauptstraße 48, 5020 Salzburg, Austria; Department of Pulmonary Medicine, Faculty of Medicine, Kepler-University-Hospital, Johannes-Kepler-University, Krankenhausstraße 9, 4021 Linz, Austria.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ermolao', 'Affiliation': 'Sport and Exercise Medicine Division, Department of Medicine, University of Padova, Via Giustiniani 2, 35128 Padova, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Studnicka', 'Affiliation': 'University Clinic of Pneumology, Paracelsus Medical University of Salzburg, Müllner Hauptstraße 48, 5020 Salzburg, Austria.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Niebauer', 'Affiliation': 'University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University of Salzburg, Lindhofstraße 20, 5020 Salzburg, Austria; Research Institute for Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University of Salzburg, Lindhofstraße 20, 5020 Salzburg, Austria. Electronic address: j.niebauer@salk.at.'}]",The American journal of medicine,['10.1016/j.amjmed.2020.07.004']
2290,31941372,Dysfunctional High-Density Lipoproteins Are Associated With a Greater Incidence of Acute Coronary Syndrome in a Population at High Cardiovascular Risk: A Nested Case-Control Study.,"BACKGROUND


Studies have failed to establish a clear link between high-density lipoprotein (HDL) cholesterol and cardiovascular disease, leading to the hypothesis that the atheroprotective role of HDL lies in its biological activity rather than in its cholesterol content. However, to date, the association between HDL functional characteristics and acute coronary syndrome has not been investigated comprehensively.
METHODS


We conducted a case-control study nested within the PREDIMED (Prevención con Dieta Mediterránea) cohort, originally a randomized trial in which participants followed a Mediterranean or low-fat diet. Incident acute coronary syndrome cases (N=167) were individually matched (1:2) to control patients by sex, age, intervention group, body mass index, and follow-up time. We investigated 2 individual manifestations (myocardial infarction, unstable angina) as secondary outcomes. We measured the following functional characteristics: HDL cholesterol concentration (in plasma); cholesterol efflux capacity; antioxidant ability, measured by the HDL oxidative-inflammatory index; phospholipase A2 activity; and sphingosine-1-phosphate, apolipoproteins A-I and A-IV, serum amyloid A, and complement 3 protein (in apolipoprotein B-depleted plasma). We used conditional logistic regression models adjusted for HDL cholesterol levels and cardiovascular risk factors to estimate odds ratios (ORs) between 1-SD increments in HDL functional characteristics and clinical outcomes.
RESULTS


Low values of cholesterol efflux capacity (OR 1SD , 0.58; 95% CI, 0.40-0.83) and low levels of sphingosine-1-phosphate (OR 1SD , 0.70; 95% CI, 0.52-0.92) and apolipoprotein A-I (OR 1SD , 0.58; 95% CI, 0.42-0.79) were associated with higher odds of acute coronary syndrome. Higher HDL oxidative inflammatory index values were marginally linked to acute coronary syndrome risk (OR 1SD , 1.27; 95% CI, 0.99-1.63). Low values of cholesterol efflux capacity (OR 1SD , 0.33; 95% CI, 0.18-0.61), sphingosine-1-phosphate (OR 1SD : 0.60; 95% CI: 0.40-0.89), and apolipoprotein A-I (OR 1SD , 0.59; 95% CI, 0.37-0.93) were particularly linked to myocardial infarction, whereas high HDL oxidative-inflammatory index values (OR 1SD , 1.53; 95% CI, 1.01-2.33) and low apolipoprotein A-I levels (OR 1SD , 0.52; 95% CI, 0.31-0.88) were associated with unstable angina.
CONCLUSIONS


Low cholesterol efflux capacity values, pro-oxidant/proinflammatory HDL particles, and low HDL levels of sphingosine-1-phosphate and apolipoprotein A-I were associated with increased odds of acute coronary syndrome and its manifestations in individuals at high cardiovascular risk.
CLINICAL TRIAL REGISTRATION


URL: https://www.controlled-trials.com/ISRCTN35739639. Unique identifier: ISRCTN35739639.",2020,"RESULTS


Low values of cholesterol efflux capacity (OR 1SD , 0.58; 95% CI, 0.40-0.83) and low levels of sphingosine-1-phosphate (OR 1SD , 0.70; 95% CI, 0.52-0.92) and apolipoprotein A-I (OR 1SD , 0.58; 95% CI, 0.42-0.79) were associated with higher odds of acute coronary syndrome.","['participants followed a Mediterranean or low-fat diet', 'Incident acute coronary syndrome cases (N=167']",[],"['high HDL oxidative-inflammatory index values', 'functional characteristics: HDL cholesterol concentration (in plasma); cholesterol efflux capacity; antioxidant ability, measured by the HDL oxidative-inflammatory index; phospholipase A2 activity; and sphingosine-1-phosphate, apolipoproteins A-I and A-IV, serum amyloid A, and complement 3 protein (in apolipoprotein B-depleted plasma', 'cholesterol efflux capacity', 'Low values of cholesterol efflux capacity', 'low levels of sphingosine-1-phosphate', 'acute coronary syndrome risk', 'low apolipoprotein A-I levels', 'myocardial infarction', 'acute coronary syndrome', 'Higher HDL oxidative inflammatory index values', 'unstable angina']","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0868928', 'cui_str': 'Case'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031667', 'cui_str': 'Phospholipase A>2<'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}, {'cui': 'C0002723', 'cui_str': 'Serum amyloid A protein'}, {'cui': 'C0009506', 'cui_str': 'Complement component C3'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}]",,0.102393,"RESULTS


Low values of cholesterol efflux capacity (OR 1SD , 0.58; 95% CI, 0.40-0.83) and low levels of sphingosine-1-phosphate (OR 1SD , 0.70; 95% CI, 0.52-0.92) and apolipoprotein A-I (OR 1SD , 0.58; 95% CI, 0.42-0.79) were associated with higher odds of acute coronary syndrome.","[{'ForeName': 'María Trinidad', 'Initials': 'MT', 'LastName': 'Soria-Florido', 'Affiliation': 'Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain (M.T.S.-F., O.C., C.L., R. Elosua, A.H., M.Fitó).'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Castañer', 'Affiliation': 'Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain (M.T.S.-F., O.C., C.L., R. Elosua, A.H., M.Fitó).'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Lassale', 'Affiliation': 'Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain (M.T.S.-F., O.C., C.L., R. Elosua, A.H., M.Fitó).'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': 'CIBER (Centro de Investigación Biomédica en Red) of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain (O.C., R. Estruch, J.S.-S., M.Á.M.-G., D.C., E.R., F.A., J.L., M.Fiol, A.A.-G., E.G.-G., L.S.-M., X.P., M.B., M.R.-C., J.V.S., A.H., M.Fitó).'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Salas-Salvadó', 'Affiliation': 'CIBER (Centro de Investigación Biomédica en Red) of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain (O.C., R. Estruch, J.S.-S., M.Á.M.-G., D.C., E.R., F.A., J.L., M.Fiol, A.A.-G., E.G.-G., L.S.-M., X.P., M.B., M.R.-C., J.V.S., A.H., M.Fitó).'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Martínez-González', 'Affiliation': 'CIBER (Centro de Investigación Biomédica en Red) of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain (O.C., R. Estruch, J.S.-S., M.Á.M.-G., D.C., E.R., F.A., J.L., M.Fiol, A.A.-G., E.G.-G., L.S.-M., X.P., M.B., M.R.-C., J.V.S., A.H., M.Fitó).'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Corella', 'Affiliation': 'CIBER (Centro de Investigación Biomédica en Red) of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain (O.C., R. Estruch, J.S.-S., M.Á.M.-G., D.C., E.R., F.A., J.L., M.Fiol, A.A.-G., E.G.-G., L.S.-M., X.P., M.B., M.R.-C., J.V.S., A.H., M.Fitó).'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Ros', 'Affiliation': 'CIBER (Centro de Investigación Biomédica en Red) of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain (O.C., R. Estruch, J.S.-S., M.Á.M.-G., D.C., E.R., F.A., J.L., M.Fiol, A.A.-G., E.G.-G., L.S.-M., X.P., M.B., M.R.-C., J.V.S., A.H., M.Fitó).'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Arós', 'Affiliation': 'CIBER (Centro de Investigación Biomédica en Red) of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain (O.C., R. Estruch, J.S.-S., M.Á.M.-G., D.C., E.R., F.A., J.L., M.Fiol, A.A.-G., E.G.-G., L.S.-M., X.P., M.B., M.R.-C., J.V.S., A.H., M.Fitó).'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Elosua', 'Affiliation': 'Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain (M.T.S.-F., O.C., C.L., R. Elosua, A.H., M.Fitó).'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Lapetra', 'Affiliation': 'CIBER (Centro de Investigación Biomédica en Red) of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain (O.C., R. Estruch, J.S.-S., M.Á.M.-G., D.C., E.R., F.A., J.L., M.Fiol, A.A.-G., E.G.-G., L.S.-M., X.P., M.B., M.R.-C., J.V.S., A.H., M.Fitó).'}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Fiol', 'Affiliation': 'CIBER (Centro de Investigación Biomédica en Red) of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain (O.C., R. Estruch, J.S.-S., M.Á.M.-G., D.C., E.R., F.A., J.L., M.Fiol, A.A.-G., E.G.-G., L.S.-M., X.P., M.B., M.R.-C., J.V.S., A.H., M.Fitó).'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Alonso-Gómez', 'Affiliation': 'CIBER (Centro de Investigación Biomédica en Red) of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain (O.C., R. Estruch, J.S.-S., M.Á.M.-G., D.C., E.R., F.A., J.L., M.Fiol, A.A.-G., E.G.-G., L.S.-M., X.P., M.B., M.R.-C., J.V.S., A.H., M.Fitó).'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Gómez-Gracia', 'Affiliation': 'CIBER (Centro de Investigación Biomédica en Red) of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain (O.C., R. Estruch, J.S.-S., M.Á.M.-G., D.C., E.R., F.A., J.L., M.Fiol, A.A.-G., E.G.-G., L.S.-M., X.P., M.B., M.R.-C., J.V.S., A.H., M.Fitó).'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Serra-Majem', 'Affiliation': 'CIBER (Centro de Investigación Biomédica en Red) of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain (O.C., R. Estruch, J.S.-S., M.Á.M.-G., D.C., E.R., F.A., J.L., M.Fiol, A.A.-G., E.G.-G., L.S.-M., X.P., M.B., M.R.-C., J.V.S., A.H., M.Fitó).'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pintó', 'Affiliation': 'CIBER (Centro de Investigación Biomédica en Red) of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain (O.C., R. Estruch, J.S.-S., M.Á.M.-G., D.C., E.R., F.A., J.L., M.Fiol, A.A.-G., E.G.-G., L.S.-M., X.P., M.B., M.R.-C., J.V.S., A.H., M.Fitó).'}, {'ForeName': 'Mònica', 'Initials': 'M', 'LastName': 'Bulló', 'Affiliation': 'CIBER (Centro de Investigación Biomédica en Red) of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain (O.C., R. Estruch, J.S.-S., M.Á.M.-G., D.C., E.R., F.A., J.L., M.Fiol, A.A.-G., E.G.-G., L.S.-M., X.P., M.B., M.R.-C., J.V.S., A.H., M.Fitó).'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Ruiz-Canela', 'Affiliation': 'CIBER (Centro de Investigación Biomédica en Red) of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain (O.C., R. Estruch, J.S.-S., M.Á.M.-G., D.C., E.R., F.A., J.L., M.Fiol, A.A.-G., E.G.-G., L.S.-M., X.P., M.B., M.R.-C., J.V.S., A.H., M.Fitó).'}, {'ForeName': 'Jose V', 'Initials': 'JV', 'LastName': 'Sorlí', 'Affiliation': 'CIBER (Centro de Investigación Biomédica en Red) of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain (O.C., R. Estruch, J.S.-S., M.Á.M.-G., D.C., E.R., F.A., J.L., M.Fiol, A.A.-G., E.G.-G., L.S.-M., X.P., M.B., M.R.-C., J.V.S., A.H., M.Fitó).'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Hernáez', 'Affiliation': 'Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain (M.T.S.-F., O.C., C.L., R. Elosua, A.H., M.Fitó).'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Fitó', 'Affiliation': 'Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain (M.T.S.-F., O.C., C.L., R. Elosua, A.H., M.Fitó).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.041658']
2291,32065775,Sex Differences in Primary and Secondary Prevention of Cardiovascular Disease in China.,"BACKGROUND


Despite improvements in diagnostic and therapeutic interventions to combat cardiovascular disease (CVD) in recent decades, there are significant ongoing access gaps and sex disparities in prevention that have not been adequately quantified in China.
METHODS


A representative, cross-sectional, community-based survey of adults (aged ≥45 years) was conducted in 7 geographic regions of China between 2014 and 2016. Logistic regression models were used to determine sex differences in primary and secondary CVD prevention, and any interaction by age, education level, and area of residence. Data are presented as adjusted odds ratios (ORs) and 95% CIs.
RESULTS


Of 47 841 participants (61.3% women), 5454 (57.2% women) had established CVD and 9532 (70.5% women) had a high estimated 10-year CVD risk (≥10%). Only 48.5% and 48.6% of women and 39.3% and 59.8% of men were on any kind of blood pressure (BP)-lowering medication, lipid-lowering medication, or antiplatelet therapy for primary and secondary prevention, respectively. Women with established CVD were significantly less likely than men to receive BP-lowering medications (OR, 0.79 [95% CI, 0.65-0.95]), lipid-lowering medications (OR, 0.69 [95% CI, 0.56-0.84]), antiplatelets (OR, 0.53 [95% CI, 0.45-0.62]), or any CVD prevention medication (OR, 0.62 [95% CI, 0.52-0.73]). Women with established CVD, however, had better BP control (OR, 1.31 [95% CI, 1.14-1.50]) but less well-controlled low-density lipoprotein cholesterol (OR, 0.66 [95% CI, 0.57-0.76]), and were less likely to smoke (OR, 13.89 [95% CI, 11.24-17.15]) and achieve physical activity targets (OR, 1.92 [95% CI, 1.61-2.29]). Conversely, women with high CVD risk were less likely than men to have their BP, low-density lipoprotein cholesterol, and bodyweight controlled (OR, 0.46 [95% CI, 0.38-0.55]; OR, 0.60 [95% CI, 0.52-0.69]; OR, 0.55 [95% CI, 0.48-0.63], respectively), despite a higher use of BP-lowering medications (OR, 1.21 [95% CI, 1.01-1.45]). Younger patients (<65 years) with established CVD were less likely to be taking CVD preventive medications, but there were no sex differences by area of residence or education level.
CONCLUSIONS


Large and variable gaps in primary and secondary CVD prevention exist in China, particularly for women. Effective CVD prevention requires an improved overall nationwide strategy and a special emphasis on women with established CVD, who have the greatest disparity and the most to benefit.",2020,"Women with established CVD, however, had better BP control (OR, 1.31 [95% CI, 1.14-1.50]) but less well-controlled low-density lipoprotein cholesterol (OR, 0.66 [95% CI, 0.57-0.76]), and were less likely to smoke (OR, 13.89 [95% CI, 11.24-17.15]) and achieve physical activity targets (OR, 1.92 [95% CI, 1.61-2.29]).","['Younger patients (<65 years) with established CVD', 'A representative, cross-sectional, community-based survey of adults (aged ≥45 years) was conducted in 7 geographic regions of China between 2014 and 2016', 'women with established CVD']",[],"['blood pressure', 'physical activity targets', 'BP-lowering medications', 'density lipoprotein cholesterol', 'BP control', '10-year CVD risk', 'lipid-lowering medications']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0441994', 'cui_str': 'Lower'}]",47841.0,0.403527,"Women with established CVD, however, had better BP control (OR, 1.31 [95% CI, 1.14-1.50]) but less well-controlled low-density lipoprotein cholesterol (OR, 0.66 [95% CI, 0.57-0.76]), and were less likely to smoke (OR, 13.89 [95% CI, 11.24-17.15]) and achieve physical activity targets (OR, 1.92 [95% CI, 1.61-2.29]).","[{'ForeName': 'Shijun', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, China (S.X., X.D., L.G., J. Dong, C.M.).'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, China (S.X., X.D., L.G., J. Dong, C.M.).'}, {'ForeName': 'Lizhu', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, China (S.X., X.D., L.G., J. Dong, C.M.).'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Beijing Centre for Disease Prevention and Control, China (J. Du).'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Arnott', 'Affiliation': 'Heart Health Research Centre, Beijing, China (X.D., C.S.A.).'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia (X.D., C.A., C.S.P.L., M.D.H., C.S.A.).'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Huffman', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia (X.D., C.A., C.S.P.L., M.D.H., C.S.A.).'}, {'ForeName': 'Hisatomi', 'Initials': 'H', 'LastName': 'Arima', 'Affiliation': 'Department of Preventive Medicine and Public Health, Faculty of Medicine, Fukuoka University, Japan (H.A.).'}, {'ForeName': 'Yiqiang', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': ""The Seventh People's Hospital of Zhengzhou, Henan Province, China (Y.Y.).""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Cardiology, The First Hospital of Jilin University, Changchun, China (Y.Z.).'}, {'ForeName': 'Shulin', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China (S.W.).'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Guang', 'Affiliation': 'Department of Cardiology, Yanan Hospital of Kunming, Kunming, Yunnan Province, China (X.G.).'}, {'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, Urumchi, Xinjiang Uyghur Autonomous Region, China (X.Z.).'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Yinzhou District Centre for Disease Control and Prevention, Ningbo, Zhejiang Province, China (H.L.).'}, {'ForeName': 'Xiaoshu', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'Cardiovascular Department, The Second Affiliated Hospital of Nanchang University, Jiangxi Province, China (X.C.).'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia (X.D., C.A., C.S.P.L., M.D.H., C.S.A.).'}, {'ForeName': 'Jianzeng', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, China (S.X., X.D., L.G., J. Dong, C.M.).'}, {'ForeName': 'Changsheng', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, China (S.X., X.D., L.G., J. Dong, C.M.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.043731']
2292,32784412,Gamma-Polyglutamic Acid-Rich Natto Suppresses Postprandial Blood Glucose Response in the Early Phase after Meals: A Randomized Crossover Study.,"We evaluated the suppressive effects of high-gamma-polyglutamic acid ( γ -PGA) natto on postprandial blood glucose level and insulin response. After confirming the eligibility of candidates using a pre-selective test with packaged white rice, a meal loading test including low- or high- γ -PGA natto (with 57.6 mg (LPGA) and 439.6 mg (HPGA) of  γ -PGA, respectively) was conducted in men aged 20 to 70 years ( n  = 29) and postmenopausal women aged ≤70 years ( n  = 7). On each examination day, blood samples were obtained after they fasted overnight and for 120 min after test meal loading. The primary outcome of this study was the difference between the measurements of the incremental area under the curve (IAUC) for blood glucose 0 to 30 min after loading of LPGA and HPGA meals. The IAUCs for blood glucose and insulin after the HPGA meal were lower than those after the LPGA meal within 45 min (0 to 15 and 0 to 30 min:  p  < 0.001, 0 to 45 min:  p  < 0.01) and 1 h (all  p  < 0.001) of loading, respectively. The suppressive effects of HPGA natto on postprandial glucose response in the early phase, which possibly relates to the risk of dysglycemia and cardiovascular disease, were clarified.",2020,The IAUCs for blood glucose and insulin after the HPGA meal were lower than those after the LPGA meal within 45 min (0 to 15 and 0 to 30 min:  ,"['Early Phase after Meals', 'men aged 20 to 70 years ( n  = 29) and postmenopausal women aged ≤70 years ( n  = 7']","['high-gamma-polyglutamic acid ( γ -PGA', 'low- or high- γ -PGA natto (with 57.6 mg (LPGA', 'Gamma-Polyglutamic Acid-Rich Natto', 'HPGA natto']","['Postprandial Blood Glucose Response', 'blood glucose and insulin', 'postprandial blood glucose level and insulin response', 'postprandial glucose response', 'incremental area under the curve (IAUC) for blood glucose']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1723263', 'cui_str': 'poly(gamma-glutamic acid)'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1258093', 'cui_str': 'Natto'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",,0.0473148,The IAUCs for blood glucose and insulin after the HPGA meal were lower than those after the LPGA meal within 45 min (0 to 15 and 0 to 30 min:  ,"[{'ForeName': 'Risa', 'Initials': 'R', 'LastName': 'Araki', 'Affiliation': 'Department of Clinical and Translational Research Methodology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Ibaraki, Tsukuba 305-8575, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Gastroenterology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Ibaraki, Tsukuba 305-8575, Japan.'}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Maruo', 'Affiliation': 'Department of Biostatistics, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Ibaraki, Tsukuba 305-8575, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Araki', 'Affiliation': 'Faculty of Health Science, Tsukuba International University, 6-8-33 Manabe, Ibaraki, Tsuchiura 300-0051, Japan.'}, {'ForeName': 'Rena', 'Initials': 'R', 'LastName': 'Miyakawa', 'Affiliation': 'Department of Clinical and Translational Research Methodology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Ibaraki, Tsukuba 305-8575, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Department of Internal Medicine (Endocrinology and Metabolism), Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Ibaraki, Tsukuba 305-8575, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Clinical and Translational Research Methodology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Ibaraki, Tsukuba 305-8575, Japan.'}]",Nutrients,['10.3390/nu12082374']
2293,32784446,Influence of a Six-Week Swimming Training with Added Respiratory Dead Space on Respiratory Muscle Strength and Pulmonary Function in Recreational Swimmers.,"The avoidance of respiratory muscle fatigue and its repercussions may play an important role in swimmers' health and physical performance. Thus, the aim of this study was to investigate whether a six-week moderate-intensity swimming intervention with added respiratory dead space (ARDS) resulted in any differences in respiratory muscle variables and pulmonary function in recreational swimmers. A sample of 22 individuals (recreational swimmers) were divided into an experimental (E) and a control (C) group, observed for maximal oxygen uptake (VO 2 max). The intervention involved 50 min of front crawl swimming performed at 60% VO 2 max twice weekly for six weeks. Added respiratory dead space was induced via tube breathing (1000 mL) in group E during each intervention session. Respiratory muscle strength variables and pulmonary and respiratory variables were measured before and after the intervention. The training did not increase the inspiratory or expiratory muscle strength or improve spirometric parameters in any group. Only in group E, maximal tidal volume increased by 6.3% ( p  = 0.01). The ARDS volume of 1000 mL with the diameter of 2.5 cm applied in moderate-intensity swimming training constituted too weak a stimulus to develop respiratory muscles and lung function measured in the spirometry test.",2020,"Only in group E, maximal tidal volume increased by 6.3% ( p  = 0.01).","['Recreational Swimmers', '22 individuals (recreational swimmers', 'recreational swimmers']","['Six-Week Swimming Training with Added Respiratory Dead Space', 'six-week moderate-intensity swimming intervention with added respiratory dead space (ARDS']","['inspiratory or expiratory muscle strength or improve spirometric parameters', 'Respiratory muscle strength variables and pulmonary and respiratory variables', 'Respiratory Muscle Strength and Pulmonary Function', 'maximal tidal volume']","[{'cui': 'C0450068', 'cui_str': 'Swimmer'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0035218', 'cui_str': 'Respiratory dead space'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}]",,0.0169109,"Only in group E, maximal tidal volume increased by 6.3% ( p  = 0.01).","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Szczepan', 'Affiliation': 'Department of Swimming, Faculty of Physical Education, University School of Physical Education in Wroclaw, Ignacego Jana Paderewskiego 35, Swimming Pool, 51-612 Wroclaw, Poland.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Danek', 'Affiliation': 'Department of Physiology and Biochemistry, Faculty of Physical Education, University School of Physical Education in Wroclaw, Ignacego Jana Paderewskiego 35, P-3 Building, 51-612 Wroclaw, Poland.'}, {'ForeName': 'Kamil', 'Initials': 'K', 'LastName': 'Michalik', 'Affiliation': 'Department of Physiology and Biochemistry, Faculty of Physical Education, University School of Physical Education in Wroclaw, Ignacego Jana Paderewskiego 35, P-3 Building, 51-612 Wroclaw, Poland.'}, {'ForeName': 'Zofia', 'Initials': 'Z', 'LastName': 'Wróblewska', 'Affiliation': 'Faculty of Pure and Applied Mathematics, Wroclaw University of Science and Technology, Zygmunta Janiszewskiego 14a, C-11 Building, 50-372 Wroclaw, Poland.'}, {'ForeName': 'Krystyna', 'Initials': 'K', 'LastName': 'Zatoń', 'Affiliation': 'Department of Swimming, Faculty of Physical Education, University School of Physical Education in Wroclaw, Ignacego Jana Paderewskiego 35, Swimming Pool, 51-612 Wroclaw, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17165743']
2294,31934945,Nurse Continuity at Discharge and Return to Hospital.,"BACKGROUND


Promoting continuity of nurse assignment during discharge care has the potential to increase patient readiness for discharge-which has been associated with fewer readmissions and emergency department visits. The few studies that examined nurse continuity during acute care hospitalizations did not focus on discharge or postdischarge outcomes.
OBJECTIVES


The aim of this research was to examine the association of continuity in nurse assignment to patients prior to hospital discharge with return to hospital (readmission and emergency department or observation visits), including exploration of the mediating pathway through patient readiness for discharge and moderating effects of unit environment and unit nurse characteristics.
METHODS


In a sample of 18,203 adult, medical-surgical patients from 31 Magnet hospitals, a correlational path analysis design was used in a secondary analysis to evaluate the effect of nurse continuity on readmissions and emergency department or observation visits within 30 days after hospital discharge. The mediating pathway through discharge readiness measured by patient self-report and nurse assessments was also assessed. Moderating effects of unit environment and nursing characteristics were examined across quartiles of unit environment (nurse staffing hours per patient day) and unit nurse characteristics (education and experience). Analyses were adjusted for patient characteristics, unit fixed effects, and clustering at the unit level.
RESULTS


Continuous nurse assignment on the last 2 days of hospitalization was observed in 6,441 (35.4%) patient discharges and was associated with a 0.85 absolute percentage point reduction (7.8% relative reduction) in readmissions. There was no significant association with emergency department or observation visits. Sensitivity analysis revealed a stronger effect in patients with higher Elixhauser Comorbidity Indexes. Readiness for discharge was not a mediator of the effect of continuity on return to hospital. Unit characteristics were not associated with nurse continuity. No moderation effect was evident for unit environment and nurse characteristics.
DISCUSSION


Continuity of nurse assignment on the last 2 days of hospitalization can reduce readmissions. Staffing for continuity may benefit patients and healthcare systems, with greater benefits for high-comorbidity patients. Nurse continuity prior to hospital discharge should be a priority consideration in assigning acute care nurses to augment readmission reduction efforts.",2020,There was no significant association with emergency department or observation visits.,"['patients with higher Elixhauser Comorbidity Indexes', 'patients prior to hospital discharge with return to hospital (readmission and emergency department or observation visits', '18,203 adult, medical-surgical patients from 31 Magnet hospitals']",[],"['hospitalization', 'emergency department or observation visits']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0024483', 'cui_str': 'Magnet'}]",[],"[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]",18203.0,0.0191508,There was no significant association with emergency department or observation visits.,"[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Bahr', 'Affiliation': 'Sarah J. Bahr, PhD, MSN, RN, ACNS-BC, was a student at Marquette University, Milwaukee, Wisconsin at the time of the study. James Bang, PhD, is Professor, St. Ambrose University, Davenport, Iowa. Olga Yakusheva, PhD, is Associate Professor, University of Michigan, Ann Arbor. Kathleen L. Bobay, PhD, RN, NEA-BC, FAAN, is Professor, Loyola University of Chicago, Illinois. Janet Krejci, PhD, RN, is Professor and Dean of College of Nursing, Marquette University, Milwaukee, Wisconsin. Linda Costa, PhD, RN, NEA-BC, is Assistant Professor, University of Maryland, Baltimore. Ronda G. Hughes, PhD, RN, FAAN, is Associate Professor, University of South Carolina, Columbia. Morris Hamilton, PhD, is Senior Analyst, Abt Associates, Durham, North Carolina. Danielle M. Siclovan, PhD, MSN, RN, is Director, Risk Management, Froedtert Hospital, Milwaukee, Wisconsin. Marianne E. Weiss, DNSc, RN, is Professor Emerita, Marquette University, Milwaukee, Wisconsin.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Bang', 'Affiliation': ''}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Yakusheva', 'Affiliation': ''}, {'ForeName': 'Kathleen L', 'Initials': 'KL', 'LastName': 'Bobay', 'Affiliation': ''}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Krejci', 'Affiliation': ''}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Costa', 'Affiliation': ''}, {'ForeName': 'Ronda G', 'Initials': 'RG', 'LastName': 'Hughes', 'Affiliation': ''}, {'ForeName': 'Morris', 'Initials': 'M', 'LastName': 'Hamilton', 'Affiliation': ''}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Siclovan', 'Affiliation': ''}, {'ForeName': 'Marianne E', 'Initials': 'ME', 'LastName': 'Weiss', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000417']
2295,32787879,"Omega-3 polyunsaturated fatty acid supplementation versus placebo on vascular health, glycaemic control, and metabolic parameters in people with type 1 diabetes: a randomised controlled preliminary trial.","BACKGROUND


The role of omega-3 polyunsaturated fatty acids (n-3PUFA), and the potential impact of n-3PUFA supplementation, in the treatment and management of type 1 diabetes (T1D) remains unclear and controversial. Therefore, this study aimed to examine the efficacy of daily high-dose-bolus n-3PUFA supplementation on vascular health, glycaemic control, and metabolic parameters in subjects with T1D.
METHODS


Twenty-seven adults with T1D were recruited to a 6-month randomised, double-blind, placebo-controlled trial. Subjects received either 3.3 g/day of encapsulated n-3PUFA or encapsulated 3.0 g/day corn oil placebo (PLA) for 6-months, with follow-up at 9-months after 3-month washout. Erythrocyte fatty acid composition was determined via gas chromatography. Endpoints included inflammation-associated endothelial biomarkers (vascular cell adhesion molecule-1 [VCAM-1], intercellular adhesion molecule-1 [ICAM-1], E-selectin, P-selectin, pentraxin-3, vascular endothelial growth factor [VEGF]), and their mediator tumor necrosis factor alpha [TNFα] analysed via immunoassay, vascular structure (carotid intima-media thickness [CIMT]) and function (brachial artery flow mediated dilation [FMD]) determined via ultrasound technique, blood pressure, glycosylated haemoglobin (HbA1c), fasting plasma glucose (FPG), and postprandial metabolism.
RESULTS


Twenty subjects completed the trial in full. In the n-3PUFA group, the mean ± SD baseline n-3PUFA index of 4.93 ± 0.94% increased to 7.67 ± 1.86% (P < 0.001) after 3-months, and 8.29 ± 1.45% (P < 0.001) after 6-months. Total exposure to n-3PUFA over the 6-months (area under the curve) was 14.27 ± 3.05% per month under n-3PUFA, and 9.11 ± 2.74% per month under PLA (P < 0.001). VCAM-1, ICAM-1, E-selectin, P-selectin, pentraxin-3, VEGF, TNFα, CIMT, FMD, blood pressure, HbA1c, FPG, and postprandial metabolism did not differ between or within groups after treatment (P > 0.05).
CONCLUSIONS


This study indicates that daily high-dose-bolus of n-3PUFA supplementation for 6-months does not improve vascular health, glucose homeostasis, or metabolic parameters in subjects with T1D. The findings from this preliminary RCT do not support the use of therapeutic n-3PUFA supplementation in the treatment and management of T1D and its associated complications. Trial Registration ISRCTN, ISRCTN40811115. Registered 27 June 2017, http://www.isrctn.com/ISRCTN40811115 .",2020,"Total exposure to n-3PUFA over the 6-months (area under the curve) was 14.27 ± 3.05% per month under n-3PUFA, and 9.11 ± 2.74% per month under PLA (P < 0.001).","['subjects with T1D.\nMETHODS\n\n\nTwenty-seven adults with T1D', 'subjects with T1D', 'people with type 1 diabetes', 'Twenty subjects completed the trial in full']","['daily high-dose-bolus n-3PUFA supplementation', 'Omega-3 polyunsaturated fatty acid supplementation versus placebo', 'encapsulated n-3PUFA or encapsulated 3.0\xa0g/day corn oil placebo (PLA', 'omega-3 polyunsaturated fatty acids (n-3PUFA', 'n-3PUFA', 'n-3PUFA supplementation', 'placebo']","['mean\u2009±\u2009SD baseline n-3PUFA index', 'Erythrocyte fatty acid composition', 'VCAM-1, ICAM-1, E-selectin, P-selectin, pentraxin-3, VEGF, TNFα, CIMT, FMD, blood pressure, HbA1c, FPG, and postprandial metabolism', 'inflammation-associated endothelial biomarkers (vascular cell adhesion molecule-1 [VCAM-1], intercellular adhesion molecule-1 [ICAM-1], E-selectin, P-selectin, pentraxin-3, vascular endothelial growth factor [VEGF]), and their mediator tumor necrosis factor alpha [TNFα] analysed via immunoassay, vascular structure (carotid intima-media thickness [CIMT]) and function (brachial artery flow mediated dilation [FMD]) determined via ultrasound technique, blood pressure, glycosylated haemoglobin (HbA1c), fasting plasma glucose (FPG), and postprandial metabolism', 'vascular health, glycaemic control, and metabolic parameters', 'vascular health, glucose homeostasis, or metabolic parameters', 'Total exposure to n-3PUFA']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205223', 'cui_str': 'Encapsulated'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0063695', 'cui_str': 'Lymphocyte antigen CD54'}, {'cui': 'C0115305', 'cui_str': 'Lymphocyte antigen CD62E'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0174234', 'cui_str': 'PTX3 protein'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]",27.0,0.559798,"Total exposure to n-3PUFA over the 6-months (area under the curve) was 14.27 ± 3.05% per month under n-3PUFA, and 9.11 ± 2.74% per month under PLA (P < 0.001).","[{'ForeName': 'Lauren L', 'Initials': 'LL', 'LastName': ""O'Mahoney"", 'Affiliation': 'Carnegie School of Sport, Leeds Beckett University, Leeds, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Dunseath', 'Affiliation': 'Diabetes Research Group, Swansea University Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Churm', 'Affiliation': 'Applied Sports, Technology, Exercise and Medicine (A-STEM) Research Centre, Swansea University, Swansea, UK.'}, {'ForeName': 'Mel', 'Initials': 'M', 'LastName': 'Holmes', 'Affiliation': 'School of Food Science and Nutrition, Faculty of Environment, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Boesch', 'Affiliation': 'School of Food Science and Nutrition, Faculty of Environment, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Stavropoulos-Kalinoglou', 'Affiliation': 'Carnegie School of Sport, Leeds Beckett University, Leeds, UK.'}, {'ForeName': 'Ramzi A', 'Initials': 'RA', 'LastName': 'Ajjan', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, Faculty of Medicine and Health, University of Leeds, Leeds, UK.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Birch', 'Affiliation': 'School of Biomedical Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Nicolas M', 'Initials': 'NM', 'LastName': 'Orsi', 'Affiliation': ""Leeds Institute of Medical Research at St James's, St James's University Hospital, Leeds, UK.""}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Mappa', 'Affiliation': ""Leeds Institute of Medical Research at St James's, St James's University Hospital, Leeds, UK.""}, {'ForeName': 'Oliver J', 'Initials': 'OJ', 'LastName': 'Price', 'Affiliation': 'Carnegie School of Sport, Leeds Beckett University, Leeds, UK.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Campbell', 'Affiliation': 'School of Food Science and Nutrition, Faculty of Environment, University of Leeds, Leeds, LS2 9JT, UK. m.d.campbell@leeds.ac.uk.'}]",Cardiovascular diabetology,['10.1186/s12933-020-01094-5']
2296,32787892,"Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials.","BACKGROUND


In cluster randomized crossover (CRXO) trials, groups of participants (i.e., clusters) are randomly allocated to receive a sequence of interventions over time (i.e., cluster periods). CRXO trials are becoming more comment when they are feasible, as they require fewer clusters than parallel group cluster randomized trials. However, CRXO trials have not been frequently used in orthopedic fracture trials and represent a novel methodological application within the field. To disseminate the early knowledge gained from our experience initiating two cluster randomized crossover trials, we describe our process for the identification and selection of the orthopedic practices (i.e., clusters) participating in the PREP-IT program and present data to describe their key characteristics.
METHODS


The PREP-IT program comprises two ongoing pragmatic cluster randomized crossover trials (Aqueous-PREP and PREPARE) which compare the effect of iodophor versus chlorhexidine solutions on surgical site infection and unplanned fracture-related reoperations in patients undergoing operative fracture management. We describe the process we used to identify and select orthopedic practices (clusters) for the PREP-IT trials, along with their characteristics.
RESULTS


We identified 58 potential orthopedic practices for inclusion in the PREP-IT trials. After screening each practice for eligibility, we selected 30 practices for participation and randomized each to a sequence of interventions (15 for Aqueous-PREP and 20 for PREPARE). The majority of orthopedic practices included in the Aqueous-PREP and PREPARE trials were situated in level I trauma centers (100% and 87%, respectively). Orthopedic practices in the Aqueous-PREP trial operatively treated a median of 149 open fracture patients per year, included a median of 11 orthopedic surgeons, and had access to a median of 5 infection preventionists. Orthopedic practices in the PREPARE trial treated a median of 142 open fracture and 1090 closed fracture patients per year, included a median of 7.5 orthopedic surgeons, and had access to a median of 6 infection preventionists.
CONCLUSIONS


The PREP-IT trials provide an example of how to follow the reporting standards for cluster randomized crossover trials by providing a clear definition of the cluster unit, a thorough description of the cluster identification and selection process, and sufficient description of key cluster characteristics.
TRIAL REGISTRATION


Both trials are registered at ClinicalTrials.gov (A-PREP: NCT03385304 December 28, 2017, and PREPARE: NCT03523962 May 14, 2018).",2020,"Orthopedic practices in the PREPARE trial treated a median of 142 open fracture and 1090 closed fracture patients per year, included a median of 7.5 orthopedic surgeons, and had access to a median of 6 infection preventionists.
","['149 open fracture patients per year, included a median of 11 orthopedic surgeons, and had access to a median of 5 infection preventionists', '58 potential orthopedic practices for inclusion in the PREP-IT trials', 'patients undergoing operative fracture management', 'groups of participants (i.e., clusters', '142 open fracture and 1090 closed fracture patients per year, included a median of 7.5 orthopedic surgeons, and had access to a median of 6 infection preventionists']",['iodophor versus chlorhexidine solutions'],[],"[{'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0016662', 'cui_str': 'Fracture, open'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439508', 'cui_str': '/year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0334891', 'cui_str': 'Orthopedic surgeon'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1160964', 'cui_str': 'Fracture care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0016659', 'cui_str': 'Fracture, closed'}, {'cui': 'C4517859', 'cui_str': '7.5'}]","[{'cui': 'C0021988', 'cui_str': 'Iodophors'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]",[],2.0,0.363304,"Orthopedic practices in the PREPARE trial treated a median of 142 open fracture and 1090 closed fracture patients per year, included a median of 7.5 orthopedic surgeons, and had access to a median of 6 infection preventionists.
","[{'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': 'Department of Surgery, Division of Orthopaedic Surgery, McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON, L8L 8E7, Canada. sprags@mcmaster.ca.'}, {'ForeName': 'Taryn', 'Initials': 'T', 'LastName': 'Scott', 'Affiliation': 'Department of Surgery, Division of Orthopaedic Surgery, McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON, L8L 8E7, Canada.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Dodds', 'Affiliation': 'Department of Surgery, Division of Orthopaedic Surgery, McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON, L8L 8E7, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pogorzelski', 'Affiliation': 'Department of Surgery, Division of Orthopaedic Surgery, McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON, L8L 8E7, Canada.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'McKay', 'Affiliation': 'Department of Surgery, Division of Orthopaedic Surgery, McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON, L8L 8E7, Canada.'}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Harris', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Wood', 'Affiliation': 'Association of periOperative Registered Nurses, Denver, CO, USA.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, 293 Wellington St. N., Suite 110, Hamilton, ON, L8L 8E7, Canada.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': 'Department of Surgery, Division of Orthopaedic Surgery, McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON, L8L 8E7, Canada.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Department of Orthopaedic Surgery, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Gaski', 'Affiliation': 'Department of Orthopaedic Surgery, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Boulton', 'Affiliation': 'Department of Orthopaedics, Banner Health and the University of Arizona-Tucson, Tucson, AZ, USA.'}, {'ForeName': 'Francesc', 'Initials': 'F', 'LastName': 'Marcano-Fernández', 'Affiliation': ""Orthopedic Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Sabadell, Spain.""}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Guerra-Farfán', 'Affiliation': ""Department of Orthopaedic Surgery and Traumatology, University Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Hebden', 'Affiliation': 'Department of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Lyndsay M', 'Initials': 'LM', 'LastName': ""O'Hara"", 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Gerard P', 'Initials': 'GP', 'LastName': 'Slobogean', 'Affiliation': 'Department of Orthopaedics, University of Maryland, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04611-9']
2297,32787893,"Effects of ""Thursdays at the Museum"" at the Montreal Museum of Fine Arts on the mental and physical health of older community dwellers: the art-health randomized clinical trial protocol.","BACKGROUND


Recently, we demonstrated that the Montreal Museum of Fine Arts' (MMFA) participatory art-based activity, known as ""Thursdays at the Museum,"" improved the well-being, quality of life, and physical health (i.e., frailty) of older community dwellers by using a pre-post intervention, single arm, prospective and longitudinal experimental design. The present randomized clinical trial (RCT), known as the Art-Health RCT (A-Health RCT), aims to compare changes in well-being, quality of life, frailty, and physiological measures in older community dwellers who participate in ""Thursdays at the Museum"" (intervention group) and in their counterparts who do not participate in this art-based activity (control group).
METHODS/DESIGN


The current unicenter, randomized, clinical, controlled, comparative trial recruits 150 older community dwellers to two parallel arms (75 participants in the intervention group and 75 participants in the control group). The intervention is a 3-month cycle of weekly ""Thursdays at the Museum,"" which are structured 2-h-long art-based workshops performed in a group setting at the MMFA. The control group is composed of participants who do not take part in art-based activities, receive their usual health and/or social services, and commit to report any other activity practiced during the same time. Assessments of the primary outcome (well-being) and the secondary outcomes (quality of life, frailty, and physiological measures including heart rate, daily step count, sleep duration, and its phases) are performed on six occasions: at baseline, at the beginning of the second and third months, at the end of the third month, as well as 6 and 12 months after the last workshop. Statistical analyses are performed with the intention to treat and per protocol. Comparisons of changes in outcome measures between intervention and control groups use repeated measures tests.
DISCUSSION


Art-based activities carried out at museums have been receiving increased interest from researchers and policy-makers because of their benefits to mental and physical health. There are few robust studies, such as RCTs, that focus on older community dwellers or assess the efficacy of these participatory museum activities. The A-Health RCT study provides an opportunity to confirm the benefits of a participatory art-based museum activity on the elderly population and to show the key role played by museums in public health promotion.
TRIAL REGISTRATION


NCT03679715 ; Title: A-Health RCT: Effects of Participatory Art-Based Activity on Health of Older Community Dwellers; First posted date: September 20, 2018; prospectively registered.",2020,"Assessments of the primary outcome (well-being) and the secondary outcomes (quality of life, frailty, and physiological measures including heart rate, daily step count, sleep duration, and its phases) are performed on six occasions: at baseline, at the beginning of the second and third months, at the end of the third month, as well as 6 and 12 months after the last workshop.","['Older Community Dwellers', 'older community dwellers', 'older community dwellers who participate in ""Thursdays at the Museum"" (intervention group) and in their counterparts who do not participate in this art-based activity (control group', '150 older community dwellers to two parallel arms (75 participants in the intervention group and 75 participants in the control group']",['Participatory Art-Based Activity'],"['secondary outcomes (quality of life, frailty, and physiological measures including heart rate, daily step count, sleep duration, and its phases']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0585028', 'cui_str': 'Thursday'}, {'cui': 'C0026863', 'cui_str': 'Museum'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",150.0,0.047586,"Assessments of the primary outcome (well-being) and the secondary outcomes (quality of life, frailty, and physiological measures including heart rate, daily step count, sleep duration, and its phases) are performed on six occasions: at baseline, at the beginning of the second and third months, at the end of the third month, as well as 6 and 12 months after the last workshop.","[{'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Beauchet', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, Sir Mortimer B. Davis Jewish General Hospital and Lady Davis Institute for Medical Research, McGill University, 3755 chemin de la Côte-Sainte-Catherine, Montréal, Quebec, H3T 1E2, Canada. olivier.beauchet@mcgill.ca.'}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Cooper-Brown', 'Affiliation': 'Centre of Excellence on Longevity of the McGill Integrated University Health Network, Montreal, Quebec, Canada.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Hayashi', 'Affiliation': 'Faculty of Informatics for Arts Department of Information Expression, Shobi University, Kawagoe, Japan.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Galery', 'Affiliation': 'Centre of Excellence on Longevity of the McGill Integrated University Health Network, Montreal, Quebec, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Vilcocq', 'Affiliation': 'Centre of Excellence on Longevity of the McGill Integrated University Health Network, Montreal, Quebec, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bastien', 'Affiliation': 'Education and Wellness Department of the Montreal Museum of Fine Arts, Montreal, Quebec, Canada.'}]",Trials,['10.1186/s13063-020-04625-3']
2298,32787896,The effect of a telerehabilitation virtual reality intervention on functional upper limb activities in people with multiple sclerosis: a study protocol for the TEAMS pilot randomized controlled trial.,"BACKGROUND


Approximately 60% of people with multiple sclerosis (PwMS) suffer from upper limb dysfunction. Our primary goal is to implement a single-blind, randomized control trial (RCT) designed to compare the effectiveness of an 8-week home-based telerehab virtual reality (VR) program with conventional therapy in PwMS with manual dexterity difficulties. Secondary aims include (a) evaluating the impact of the programs on quality of life after the intervention and a follow-up 1 month later and (b) evaluating the impact of the programs on adherence and satisfaction.
METHODS


Twenty-four PwMS will be recruited to the study which will be conducted at two established MS centers: (1) The Regional Center for Diagnosis and Treatment of Multiple Sclerosis, Binaghi Hospital, Cagliari, Italy, and (2) The Multiple Sclerosis Center, Sheba Medical Center, Tel-Hashomer, Israel. Participants will complete a total of three assessments focusing on upper limb functions. Both groups will receive 16 training sessions focusing on functional upper limb activities. The home-based telerehab VR intervention will comprise a custom-made software program running on a private computer or laptop. PwMS will perform several activities of daily living (ADL) functions associated with self-care, dressing, and meal preparation. Conventional therapy will focus on task-related upper-limb treatments while in a sitting position, indicative of the standard care in MS. Following 8 weeks of training, participants will complete a further outcome assessment. The same tests will be conducted 1 month (as a follow-up) after completion of the intervention.
DISCUSSION


The outcomes of this study have tremendous potential to improve the quality of evidence and informed decisions of functional upper limb activities in PwMS. If comparable results are found between the treatments in improving upper limb outcomes, this would suggest that PwMS can choose the program that best meets their personal needs, e.g., financial concerns, transportation, or accessibility issues. Secondly, this information can be used by healthcare providers and medical professionals in developing upper limb exercise programs that will most likely succeed in PwMS.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04032431 . Registered on 19 July 2019.",2020,The home-based telerehab VR intervention will comprise a custom-made software program running on a private computer or laptop.,"['people with multiple sclerosis', 'people with multiple sclerosis (PwMS) suffer from upper limb dysfunction', 'Twenty-four PwMS will be recruited to the study which will be conducted at two established MS centers: (1) The Regional Center for Diagnosis and Treatment of Multiple Sclerosis, Binaghi Hospital, Cagliari, Italy, and (2', 'PwMS with manual dexterity difficulties']","['telerehabilitation virtual reality intervention', '8-week home-based telerehab virtual reality (VR) program with conventional therapy', 'Conventional therapy']","['quality of life', 'functional upper limb activities', 'adherence and satisfaction']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0558281', 'cui_str': 'Regional center'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]","[{'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0579116', 'cui_str': 'Upper limb activities'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0392797,The home-based telerehab VR intervention will comprise a custom-made software program running on a private computer or laptop.,"[{'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Kalron', 'Affiliation': 'Department of Physical Therapy, School of Health Professions, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel. alonkalr@post.tau.ac.il.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Achiron', 'Affiliation': 'Multiple Sclerosis Center, Sheba Medical Center, Tel Hashomer, Israel.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Pau', 'Affiliation': 'Department of Mechanical, Chemical and Materials Engineering, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Cocco', 'Affiliation': 'Multiple Sclerosis Center, Binaghi Hospital, Department of Medical Science and Public Health, University of Cagliari, Cagliari, Italy.'}]",Trials,['10.1186/s13063-020-04650-2']
2299,32787943,"Effectiveness of a family-, school- and community-based intervention on physical activity and its correlates in Belgian families with an increased risk for type 2 diabetes mellitus: the Feel4Diabetes-study.","BACKGROUND


The study aimed to investigate the effectiveness of the European Feel4Diabetes intervention, promoting a healthy lifestyle, on physical activity and its correlates among families at risk for type 2 diabetes mellitus (based on the Finnish Diabetes Risk Score) in Belgium.
METHODS


The Feel4Diabetes intervention involved three components: family, school and community component, with the family component consisting of 6 counseling sessions for families at risk. Main outcomes were objectively measured physical activity levels and its subjectively measured correlates. The final sample consisted of 454 parents (mean age 39.4 years; 72.0% women) and 444 children (mean age 8.0 years; 50.1% girls). Multilevel repeated measures analyses were performed to assess intervention effectiveness after 1 year.
RESULTS


In parents, there was no significant intervention effect. In children, there were only significant negative effects for moderate to vigorous physical activity (p = 0.05; η p 2  = 0.008) and steps (p = 0.03; η p 2  = 0.006%) on weekdays, with physical activity decreasing (more) in the intervention group.
CONCLUSIONS


The F4D-intervention lacks effectiveness on high-risk families' physical activity and its correlates in Belgium. This could partially be explained by low attendance rates and a large drop-out. To reach vulnerable populations, future interventions should invest in more appropriate recruitment (e.g. more face-to-face contact) and more bottom-up development of the intervention (i.e. co-creation of the intervention with the target group).
TRIAL REGISTRATION


The Feel4Diabetes-study was prospectively registered at clinicaltrials.gov as NCT02393872 on 20 March 2015.",2020,"In children, there were only significant negative effects for moderate to vigorous physical activity (p = 0.05; η p 2  = 0.008) and steps (p = 0.03; η p 2  = 0.006%) on weekdays, with physical activity decreasing (more) in the intervention group.
","['families at risk for type 2 diabetes mellitus (based on the Finnish Diabetes Risk Score) in Belgium', '454 parents (mean age 39.4\u2009years; 72.0% women) and 444 children (mean age 8.0\u2009years; 50.1% girls', 'Belgian families with an increased risk for type 2 diabetes mellitus']","['European Feel4Diabetes intervention', 'school and community component, with the family component consisting of 6 counseling sessions', 'family-, school- and community-based intervention']","['physical activity levels and its subjectively measured correlates', 'vigorous physical activity']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2732678', 'cui_str': 'Finnish diabetes risk score'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C4517782', 'cui_str': '454'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0337797', 'cui_str': 'Belgians'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0261711,"In children, there were only significant negative effects for moderate to vigorous physical activity (p = 0.05; η p 2  = 0.008) and steps (p = 0.03; η p 2  = 0.006%) on weekdays, with physical activity decreasing (more) in the intervention group.
","[{'ForeName': 'Nele', 'Initials': 'N', 'LastName': 'Huys', 'Affiliation': 'Department of Movement and Sport Sciences, Ghent University, Watersportlaan 2, 9000, Ghent, Belgium. huysnele@gmail.com.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Van Stappen', 'Affiliation': 'Department of Movement and Sport Sciences, Ghent University, Watersportlaan 2, 9000, Ghent, Belgium.'}, {'ForeName': 'Samyah', 'Initials': 'S', 'LastName': 'Shadid', 'Affiliation': 'Department of Endocrinology and Metabolic Diseases, Ghent University Hospital, Corneel Heymanslaan, 10, Ghent, Belgium.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'De Craemer', 'Affiliation': 'Department of Rehabilitation Sciences, Ghent University, Corneel Heysmanslaan, 10, Ghent, Belgium.'}, {'ForeName': 'Odysseas', 'Initials': 'O', 'LastName': 'Androutsos', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Sciences & Education, Harokopio University, El. Venizelou 70, Kallithea, Athens, Greece.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wikström', 'Affiliation': 'Department of Public Health Solutions, National Institute for Health and Welfare, Mannerheimintie, 166, Helsinki, Finland.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Makrilakis', 'Affiliation': 'First Department of Propaedeutic Internal Medicine, National and Kapodistrian University of Athens, 75 Mikras Asias str, Athens, Greece.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Moreno', 'Affiliation': 'Growth, Exercise, Nutrition and Development (GENUD) Research Group, Instituto Agroalimentario de Aragón (IA2), Instituto de Investigación Sanitaria Aragón (IIS Aragón), University of Zaragoza, Calle Pedro Cerbuna, 12, Zaragoza, Spain.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Iotova', 'Affiliation': 'Department of Paediatrics, Medical University of Varna, 55 Marin Drinov str, Varna, Bulgaria.'}, {'ForeName': 'Tsvetalina', 'Initials': 'T', 'LastName': 'Tankova', 'Affiliation': 'Clinical Center of Endocrinology, Medical University of Sofia, Boulevard ""Akademik Ivan Evstratiev Geshov, 15, Sofia, Bulgaria.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nánási', 'Affiliation': 'Department of Family and Occupational Medicine, University of Debrecen, Egyeterm tér 1, Debrecen, Hungary.'}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Manios', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Sciences & Education, Harokopio University, El. Venizelou 70, Kallithea, Athens, Greece.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Cardon', 'Affiliation': 'Department of Movement and Sport Sciences, Ghent University, Watersportlaan 2, 9000, Ghent, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC public health,['10.1186/s12889-020-09336-7']
2300,32787978,Study protocol on Enhanced Primary Healthcare (EnPHC) interventions: a quasi-experimental controlled study on diabetes and hypertension management in primary healthcare clinics.,"AIM


This paper describes the study protocol, which aims to evaluate the effectiveness of a multifaceted intervention package called 'Enhanced Primary Healthcare' (EnPHC) on the process of care and intermediate clinical outcomes among patients with Type 2 diabetes mellitus (T2DM) and hypertension. Other outcome measures include patients' experience and healthcare providers' job satisfaction.
BACKGROUND


In 2014, almost two-thirds of Malaysia's adult population aged 18 years or older had T2DM, hypertension or hypercholesterolaemia. An analysis of health system performance from 2016 to 2018 revealed that the control and management of diabetes and hypertension in Malaysia was suboptimal with almost half of the patients not diagnosed and just one-quarter of patients with diabetes appropriately treated. EnPHC framework aims to improve diagnosis and effective management of T2DM, hypertension or hypercholesterolaemia and their risk factors by increasing prevention, optimising management and improving surveillance of diagnosed patients.
METHODS


This is a quasi-experimental controlled study which involves 20 intervention and 20 control clinics in two different states in Malaysia, namely Johor and Selangor. The clinics in the two states were matched and randomly allocated to 'intervention' and 'control' arms. The EnPHC framework targets different levels from community to primary healthcare clinics and integrated referral networks.Data are collected via a retrospective chart review (RCR), patient exit survey, healthcare provider survey and an intervention checklist. The data collected are entered into tablet computers which have installed in them an offline survey application. Interrupted time series and difference-in-differences (DiD) analyses will be conducted to report outcomes.",2020,"EnPHC framework aims to improve diagnosis and effective management of T2DM, hypertension or hypercholesterolaemia and their risk factors by increasing prevention, optimising management and improving surveillance of diagnosed patients.
","['diabetes and hypertension management in primary healthcare clinics', '20 control clinics in two different states in Malaysia, namely Johor and Selangor', 'diagnosed patients', ""In 2014, almost two-thirds of Malaysia's adult population aged 18 years or older had T2DM, hypertension or hypercholesterolaemia"", 'patients with Type 2 diabetes mellitus (T2DM) and hypertension']","[""multifaceted intervention package called 'Enhanced Primary Healthcare' (EnPHC""]","[""patients' experience and healthcare providers' job satisfaction""]","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}]",,0.0247709,"EnPHC framework aims to improve diagnosis and effective management of T2DM, hypertension or hypercholesterolaemia and their risk factors by increasing prevention, optimising management and improving surveillance of diagnosed patients.
","[{'ForeName': 'Sheamini', 'Initials': 'S', 'LastName': 'Sivasampu', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Xin Rou', 'Initials': 'XR', 'LastName': 'Teh', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Yvonne Mei Fong', 'Initials': 'YMF', 'LastName': 'Lim', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Su Miin', 'Initials': 'SM', 'LastName': 'Ong', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Swee Hung', 'Initials': 'SH', 'LastName': 'Ang', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Masliyana', 'Initials': 'M', 'LastName': 'Husin', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Noraziani', 'Initials': 'N', 'LastName': 'Khamis', 'Affiliation': 'Institute for Health Management, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Faeiz Syezri Adzmin', 'Initials': 'FSA', 'LastName': 'Jaafar', 'Affiliation': 'Institute for Health Management, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Wen Jun', 'Initials': 'WJ', 'LastName': 'Wong', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Shanmugam', 'Affiliation': 'Institute for Health Management, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Siti Aminah', 'Initials': 'SA', 'LastName': 'Ismail', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Sarah Hui Li', 'Initials': 'SHL', 'LastName': 'Pang', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Nazrila Hairizan', 'Initials': 'NH', 'LastName': 'Nasir', 'Affiliation': 'Family Health Development Division, Ministry of Health Malaysia, Putrajaya, Malaysia.'}, {'ForeName': 'Mohd Safiee', 'Initials': 'MS', 'LastName': 'Ismail', 'Affiliation': 'Family Health Development Division, Ministry of Health Malaysia, Putrajaya, Malaysia.'}, {'ForeName': 'Dian', 'Initials': 'D', 'LastName': 'Kusuma', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Ross-Degnan', 'Affiliation': 'Harvard Medical School, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Rifat', 'Initials': 'R', 'LastName': 'Atun', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}]",Primary health care research & development,['10.1017/S1463423620000250']
2301,32788001,Radiotherapy Activates Matrix Metalloproteinases in the Dentinoenamel Junction of Primary Teeth.,"Purpose:  Radiation-related caries is characterized by enamel delamination near the dentinoenamel junction (DEJ). We investigated the activity and expression of the matrix metalloproteinases (MMPs) -2 and -9 in order to understand disease pathogenesis in teeth submitted or not to radiotherapy (RT).<br/>  Methods:  In situ zymography and immunofluorescence assays were performed to evaluate the activity and expression of MMPs -2 and -9, respectively. Twelve primary second molars were randomly assigned into two experimental subgroups: irradiated and nonirradiated. Dental fragments were exposed to radiation at a dose fraction of two Gy for five consecutive days until reaching the total dose of 60 Gy. The percentage of fluorescence in the DEJ was evaluated in three distinct regions of the tooth (cervical, cusp, and pit). The regions were photographed under fluorescence microscopy at 1.25× and 5× magnification.<br/>  Results:  The intensity of fluorescence per mm 2 in the DEJ was higher in the cervical region of irradiated primary teeth ( P  <0.05) versus nonirradiated ones. In these areas, immunofluorescence revealed expression of MMPs -2 and -9.<br/>  Conclusion:  Radiotherapy can increase the activity of MMPs -2 and -9 in the cervical region of the DEJ of primary teeth.",2020,The intensity of fluorescence per mm 2 in the DEJ was higher in the cervical region of irradiated primary teeth ( P  <0.05) versus nonirradiated ones.,['Twelve primary second molars'],['Radiotherapy'],"['percentage of fluorescence in the DEJ', 'intensity of fluorescence']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.0314919,The intensity of fluorescence per mm 2 in the DEJ was higher in the cervical region of irradiated primary teeth ( P  <0.05) versus nonirradiated ones.,"[{'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Queiroz', 'Affiliation': 'Dr. Queiroz, Department of Pediatric Clinics, School of Dentistry of Ribeirão Preto, University of São Paulo, Ribeirão Preto, São Paulo, Brazil;, Email: amqueiroz@forp.usp.br.'}, {'ForeName': 'Claudia M', 'Initials': 'CM', 'LastName': 'Carpio-Bonilla', 'Affiliation': 'Dr. Carpio-Bonilla, Professor, Department of Pediatric Clinics, School of Dentistry of Ribeirão Preto, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Maya F M', 'Initials': 'MFM', 'LastName': 'Arnez', 'Affiliation': 'Dr. Arnez, Research fellow, Department of Pediatric Clinics, School of Dentistry of Ribeirão Preto, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Thais T', 'Initials': 'TT', 'LastName': 'Dos Santos', 'Affiliation': 'Santos, Graduate student, Department of Pediatric Clinics, School of Dentistry of Ribeirão Preto, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Regina G', 'Initials': 'RG', 'LastName': 'Palma-Dibb', 'Affiliation': 'Dr. Palma-Dibb is a professor, Department of Restorative Dentistry, School of Dentistry of Ribeirão Preto, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Harley F', 'Initials': 'HF', 'LastName': 'Oliveira', 'Affiliation': 'Dr. Oliveira is a radiotherapist, Radio-Oncology Treatment Center, Ribeirão Preto, and at Marcio Cunha Hospital, Ipatinga, Minas Gerais, Brazil.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Nelson-Filho', 'Affiliation': 'Dr. Nelson-Filho, Professor and Dean, Department of Pediatric Clinics, School of Dentistry of Ribeirão Preto, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Lea A B', 'Initials': 'LAB', 'LastName': 'Silva', 'Affiliation': 'Silva, Professor, Department of Pediatric Clinics, School of Dentistry of Ribeirão Preto, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Francisco W G', 'Initials': 'FWG', 'LastName': 'Paula-Silva', 'Affiliation': 'Dr. Paula-Silva is an associate professor, Department of Pediatric Clinics, School of Dentistry of Ribeirão Preto, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}]","Journal of dentistry for children (Chicago, Ill.)",[]
2302,32788015,"[Application of a risk stratification-based model for prediction of acute kidney injury combined with hemoperfusion in patients with sepsis: a prospective, observational, pilot study].","OBJECTIVE


To evaluate the efficacy and safety of a risk stratification-based model for prediction of acute kidney injury (AKI) combined with hemoperfusion (HP) in the treatment of patients with sepsis.
METHODS


A prospective, observational, pilot trial was conducted. The patients who met the Sepsis-3 diagnostic criteria admitted to intensive care unit of Lanzhou University Second Hospital from May to December in 2019 were enrolled as the research objects. Through the AKI early warning model established by the research group in the early stage, AKI risk > 30% was defined as AKI high risk. Patients with AKI high risk were enrolled in the observation group, and the remaining patients were enrolled in the control group. All patients were given conventional treatment, including the search and treatment of original infection sites, the use of antibiotics and main organ function support. Patients in the observation group were combined with HP treatment on the basis of conventional treatment, 2.5 hours per day for 3 days. The baseline data of gender, age, infection site, acute physiology and chronic health evaluation II (APACHE II) score, sequential organ failure assessment (SOFA) score, mean arterial pressure (MAP) and serum creatinine (SCr) were recorded. The inflammatory indexes such as interleukin-6 (IL-6), lipopolysaccharide (LPS) and procalcitonin (PCT) were detected at ICU admission, 24 hours and 72 hours after ICU admission, and the length of ICU stay, ICU mortality and bleeding were recorded.
RESULTS


Among the 49 patients with sepsis enrolled in this study, the main diagnosis was pneumonia, and Gram-negative (G - ) bacilli were the main pathogenic bacteria [61.2% (30/49)]. Among them, 30 patients with AKI risk > 30% were in the observation group, and the remaining 19 patients were in the control group. There was no significant difference in gender, age, infection site, APACHE II score, SOFA score, MAP or other baseline data between the two groups, but the baseline value of SCr in the observation group was significantly higher than that in the control group (μmol/L: 112.2±34.4 vs. 93.4±13.0, P < 0.05). At ICU admission, there was no significant difference in IL-6, LPS or PCT between the two groups. However, with the extension of ICU time, the inflammatory indexes of the two groups showed a downward trend. At 24 hours after ICU admission, there was no significant difference in IL-6, LPS or PCT between the two groups. At 72 hours after ICU admission, IL-6 in the experimental group decreased significantly as compared with the control group (ng/L: 90.9±38.1 vs. 119.1±41.9, P < 0.05), but there was no significant difference in LPS or PCT between the two groups. The length of ICU stay in the experimental group was significantly shorter than that in the control group (days: 9.77±2.76 vs. 12.47±3.85, P < 0.01), but there was no significant difference in the ICU mortality between the experimental group and control group (20.0% vs. 21.1%, P > 0.05). None of the 49 patients had severe bleeding events.
CONCLUSIONS


The application of a risk stratification-based model for prediction of AKI combined with HP in septic patients is feasible both in theory and in clinical practice, and shortens the length of ICU stay, but fails to effectively remove inflammatory mediators or reduce sepsis mortality. A large sample, multicenter, randomized controlled study is still needed for further verification.",2020,"At 24 hours after ICU admission, there was no significant difference in IL-6, LPS or PCT between the two groups.","['septic patients', '30 patients with AKI risk > 30% were in the observation group, and the remaining 19 patients were in the control group', 'patients who met the Sepsis-3 diagnostic criteria admitted to intensive care unit of Lanzhou University Second Hospital from May to December in 2019 were enrolled as the research objects', '49 patients with sepsis enrolled in this study, the main diagnosis was pneumonia, and Gram-negative (G - ) bacilli were the main pathogenic bacteria [61.2% (30/49', 'patients with sepsis', 'Patients with AKI high risk were enrolled in the observation group, and the remaining patients were enrolled in the control group']","['HP', 'risk stratification-based model', 'hemoperfusion', 'hemoperfusion (HP']","['length of ICU stay', 'gender, age, infection site, APACHE II score, SOFA score, MAP or other baseline data', 'IL-6, LPS or PCT', 'baseline value of SCr', 'efficacy and safety', 'ICU mortality', 'severe bleeding events', 'inflammatory indexes such as interleukin-6 (IL-6), lipopolysaccharide (LPS) and procalcitonin (PCT', 'baseline data of gender, age, infection site, acute physiology and chronic health evaluation II (APACHE II) score, sequential organ failure assessment (SOFA) score, mean arterial pressure (MAP) and serum creatinine (SCr', 'LPS or PCT', 'length of ICU stay, ICU mortality and bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C4517833', 'cui_str': '61.2'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0019063', 'cui_str': 'Hemoperfusion'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0578491', 'cui_str': 'Infection by site'}, {'cui': 'C4758051', 'cui_str': 'APACHE II (Acute Physiology and Chronic Health Evaluation II) score'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0243028', 'cui_str': 'Acute physiology and chronic health evaluation II'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",49.0,0.0300337,"At 24 hours after ICU admission, there was no significant difference in IL-6, LPS or PCT between the two groups.","[{'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Feng', 'Affiliation': 'Department of Intensive Care Unit, Lanzhou University Second Hospital, Lanzhou 730000, Gansu, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Intensive Care Unit, Lanzhou University Second Hospital, Lanzhou 730000, Gansu, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""Department of Intensive Care Unit, People's Hospital of Linxia State, Linxia 731100, Gansu, China. Corresponding author: Feng Fang, Email: ery_fengf@lzu.edu.cn.""}, {'ForeName': 'Huyong', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': ""Department of Intensive Care Unit, People's Hospital of Linxia State, Linxia 731100, Gansu, China. Corresponding author: Feng Fang, Email: ery_fengf@lzu.edu.cn.""}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': ""Department of Intensive Care Unit, People's Hospital of Linxia State, Linxia 731100, Gansu, China. Corresponding author: Feng Fang, Email: ery_fengf@lzu.edu.cn.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': ""Department of Intensive Care Unit, People's Hospital of Linxia State, Linxia 731100, Gansu, China. Corresponding author: Feng Fang, Email: ery_fengf@lzu.edu.cn.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Intensive Care Unit, Lanzhou University Second Hospital, Lanzhou 730000, Gansu, China.'}]",Zhonghua wei zhong bing ji jiu yi xue,['10.3760/cma.j.cn121430-20200326-00239']
2303,32788051,Lack of effect on ambulation of dalfampridine-ER (4-AP) treatment in adult SMA patients.,"SMA is a genetically determined motor system disorder that results in muscle weakness, selective motor neuron death, muscle atrophy, and impaired functional mobility. In SMA model systems, long-term treatment with 4-aminopyridine (4-AP) has been shown to improve motor function. To assess tolerability and preliminary efficacy of 4-AP on walking ability, endurance and EMG in adult ambulatory SMA patients, we conducted a double blind, placebo control, crossover pilot study with dalfampridine (4-AP, 10 mg BID). The study is comprised of a short-term (2 weeks) treatment arm with 1-week washout and a long-term (6 weeks) treatment arm with a 2-week washout. The primary outcome measure, for which the study was powered, was the 6 min walk test (6MWT, distance and percent fatigue); secondary outcome measures were the Hammersmith Functional Motor Scale Expanded (HFMSE), Manual Muscle Testing (MMT), Myometry with Hand held Dynamometry, HHD) and Quantitative Gait Analyses. We performed electrophysiology, including CMAP and H-reflex, during the short-term treatment trial. The mean age of the 11 participants enrolled was 37.7 ± 11.9 years; 54.5% were male. Dalfampridine was safe and well tolerated and no patient suffered a serious adverse event related to treatment. We observed no statistically significant positive effects of dalfampridine treatment on our primary functional motor outcome (6MWT distance, fatigue). Dalfampridine had a positive effects on H-reflex and H/M ratio but not on CMAP amplitude. The effect on the H-reflex is of interest, as it suggests dalfampridine may enhance neuronal activity, an effect observed in SMA Drosophila and mouse models at doses (mg/kg) not recommended for clinical use. Larger studies with dalfampridine in SMA patients are needed to confirm our findings, especially in light of studies in other populations showing drug effects in only a subset of patients.",2020,Dalfampridine had a positive effects on H-reflex and H/M ratio but not on CMAP amplitude.,"['The mean age of the 11 participants enrolled was 37.7\u202f±\u202f11.9 years; 54.5% were male', 'SMA patients', 'adult ambulatory SMA patients', 'adult SMA patients']","['SMA', '4-AP', 'Dalfampridine', 'dalfampridine (4-AP, 10\u202fmg BID', '4-aminopyridine (4-AP', 'dalfampridine', 'dalfampridine-ER (4-AP', 'placebo']","['functional motor outcome (6MWT distance, fatigue', '6\xa0min walk test (6MWT, distance and percent fatigue', 'walking ability, endurance and EMG', 'H-reflex and H/M ratio', 'Hammersmith Functional Motor Scale Expanded (HFMSE), Manual Muscle Testing (MMT), Myometry with Hand held Dynamometry, HHD) and Quantitative Gait Analyses', 'safe and well tolerated']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C0000477', 'cui_str': 'dalfampridine'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0018447', 'cui_str': 'H-reflex'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0335933', 'cui_str': 'Hammersmith'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0451362', 'cui_str': 'Oxford grading scale for muscle strength'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0085106', 'cui_str': 'Familial benign pemphigus'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0558820', 'cui_str': 'Examination of gait'}]",11.0,0.104935,Dalfampridine had a positive effects on H-reflex and H/M ratio but not on CMAP amplitude.,"[{'ForeName': 'Claudia A', 'Initials': 'CA', 'LastName': 'Chiriboga', 'Affiliation': 'Division of Child Neurology, Department of Neurology, Columbia College of Physicians and Surgeons, Columbia University Medical Center, 180 Fort Washington Avenue # 552, New York, NY 10032-3791, United States. Electronic address: cac3@cumc.columbia.edu.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Marra', 'Affiliation': 'Division of Child Neurology, Department of Neurology, Columbia College of Physicians and Surgeons, Columbia University Medical Center, 180 Fort Washington Avenue # 552, New York, NY 10032-3791, United States.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'LaMarca', 'Affiliation': 'Division of Child Neurology, Department of Neurology, Columbia College of Physicians and Surgeons, Columbia University Medical Center, 180 Fort Washington Avenue # 552, New York, NY 10032-3791, United States.'}, {'ForeName': 'Sally Dunaway', 'Initials': 'SD', 'LastName': 'Young', 'Affiliation': 'Department of Neurology, Stanford University, Palo Alto, CA, United States.'}, {'ForeName': 'Louis H', 'Initials': 'LH', 'LastName': 'Weimer', 'Affiliation': 'Department of Neurology, Columbia College of Physicians and Surgeons, New York, NY, United States.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Levin', 'Affiliation': 'Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'McCabe', 'Affiliation': 'Brain Mind Institute, EPFL, Lausanne, Switzerland.'}]",Neuromuscular disorders : NMD,['10.1016/j.nmd.2020.07.007']
2304,32788052,Thiol/Disulfide Homeostasis in Patients With Erectile Dysfunction.,"BACKGROUND


Although there are no sufficient data on association between oxidative stress and erectile dysfunction (ED), numerous studies have reported that imbalance between the formation of reactive oxygen species and body's antioxidant defenses may play a role in the pathogenesis of ED.
AIM


The aim of this study was to determine and compare the oxidant and antioxidant status in patients with ED and healthy controls with a novel automated assay for thiol/disulphide homeostasis test.
METHODS


Our study included 123 patients with ED and 90 healthy individuals. ED was evaluated by asking questions 1-5 and 15 of the International Index of Erectile Function form. In this study, we used Erel and Neselioglu's thiol/disulfide homeostasis test, which is one of the novel methods that can measure both variables of the oxidative/antioxidative balance individually and collectively.
OUTCOMES


This method measured serum antioxidant (total thiol [toSH], native thiol [SH]) and oxidant (disulfide [SS]) levels. The statistical comparisons were performed between patients with ED (ED+ group) and without ED (ED- group) first and then within the ED+ group. After toSH, SH, and SS levels were determined; SS/toSH%, SS/SH%, and SH/toSH% levels were analyzed separately and compared statistically.
RESULTS


We found a significant difference between ED- and ED+ groups in terms of toSH, SH, SS/toSH%, and SS/SH% ratios. SS parameters were increased in patients with ED, but there was no significant difference in terms of SS and SH/toSH% values.
CLINICAL IMPLICATIONS


Clarification of the factors involved in the etiology of ED such as oxidative/antioxidative balance may open new grounds in the early diagnosis and treatment of the disease.
STRENGTHS & LIMITATIONS


It is a prospective, randomized clinical study with the use of a novel, reliable, and fully automated technique. The limitations of the study are use of a subjective tool such as the International Index of Erectile Function, obtaining blood samples from the peripheral vein instead of penile cavernosal tissue, and relatively small sample size.
CONCLUSION


The results of this study showed that thiol/disulfide homeostasis is altered in ED, and this imbalance may be a factor in its pathophysiology. We determined that as ED gets more severe, toSH and SH parameters decrease, whereas SS parameter increases. Micoogullari U, Karatas OF, Kisa E, et al. Thiol/Disulfide Homeostasis in Patients With Erectile Dysfunction. J Sex Med 2020;XX:XXX-XXX.",2020,"SS parameters were increased in patients with ED, but there was no significant difference in terms of SS and SH/toSH% values.
","['123 patients with ED and 90 healthy individuals', 'patients with ED and healthy controls with a novel automated assay for thiol/disulphide homeostasis test', 'Patients With Erectile Dysfunction']",[],"['SS parameters', 'oxidant and antioxidant status', 'SS/toSH%, SS/SH%, and SH/toSH% levels', 'SH, and SS levels', 'Micoogullari U, Karatas OF, Kisa E, et', 'toSH, SH, SS/toSH%, and SS/SH% ratios', 'SS and SH/toSH% values', 'serum antioxidant (total thiol [toSH], native thiol [SH]) and oxidant (disulfide [SS]) levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0038734', 'cui_str': 'Sulfhydryls'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",[],"[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038734', 'cui_str': 'Sulfhydryls'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0012771', 'cui_str': 'Disulfides'}]",123.0,0.0161754,"SS parameters were increased in patients with ED, but there was no significant difference in terms of SS and SH/toSH% values.
","[{'ForeName': 'Uygar', 'Initials': 'U', 'LastName': 'Micoogullari', 'Affiliation': 'Department of Urology, Tepecik Education and Research Hospital, University of Health Sciences, İzmir, Turkey. Electronic address: uygarmico@hotmail.com.'}, {'ForeName': 'Omer Faruk', 'Initials': 'OF', 'LastName': 'Karatas', 'Affiliation': 'Deparment of Urology, Gulhane Medical School, Health Sciences University, Ankara, Turkey.'}, {'ForeName': 'Erdem', 'Initials': 'E', 'LastName': 'Kisa', 'Affiliation': 'Department of Urology, Tepecik Education and Research Hospital, University of Health Sciences, İzmir, Turkey.'}, {'ForeName': 'Mehmet Zeynel', 'Initials': 'MZ', 'LastName': 'Keskin', 'Affiliation': 'Department of Urology, Tepecik Education and Research Hospital, University of Health Sciences, İzmir, Turkey.'}, {'ForeName': 'Ali Fuat', 'Initials': 'AF', 'LastName': 'Atmaca', 'Affiliation': 'Deparment of Urology, Memorial Hospital Ankara, Ankara, Turkey.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Neselioglu', 'Affiliation': 'Department of Biochemistry, School of Medicine, Ankara Yildirim Beyazit University, Ankara, Turkey.'}, {'ForeName': 'Ozcan', 'Initials': 'O', 'LastName': 'Erel', 'Affiliation': 'Department of Biochemistry, School of Medicine, Ankara Yildirim Beyazit University, Ankara, Turkey.'}, {'ForeName': 'Arslan', 'Initials': 'A', 'LastName': 'Ardicoglu', 'Affiliation': 'Department of Urology, School of Medicine Affiliated with Ministry of Health Ankara City Hospital, Ankara Yildirim Beyazit University, Ankara, Turkey.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2020.07.011']
2305,32788067,Risk of Leukemia in Children With Peripheral Facial Palsy.,"Most children with peripheral facial palsy will not have a cause identified. Although leukemia can cause facial nerve palsy, the magnitude of the risk is unknown and recommendations for investigations are variable. We are currently conducting a randomized, placebo-controlled trial of prednisolone for the treatment of Bell's palsy in children within the Paediatric Research in Emergency Departments International Collaborative emergency research network. In the course of the assessment for eligibility of the trial, from 644 acute-onset facial palsy presentations we identified 5 children with previously undiagnosed leukemia. We estimate the rate of leukemia in children with acute-onset facial palsy who present to emergency departments to be 0.6% (95% confidence interval 0.2% to 1.6%). In accordance with these cases, we suggest consideration of a screening CBC count for acute-onset peripheral facial palsy presentations in children before initiation of corticosteroid treatment.",2020,"We are currently conducting a randomized, placebo-controlled trial of prednisolone for the treatment of Bell's palsy in children within the Paediatric Research in Emergency Departments International Collaborative emergency research network.","['children with peripheral facial palsy', '644 acute-onset facial palsy presentations we identified 5 children with previously undiagnosed leukemia', ""Bell's palsy in children within the Paediatric Research in Emergency Departments International Collaborative emergency research network"", 'Children With Peripheral Facial Palsy', 'children with acute-onset facial palsy']","['prednisolone', 'placebo']",['rate of leukemia'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3266178', 'cui_str': 'Peripheral facial palsy'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015469', 'cui_str': 'Facial palsy'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023418', 'cui_str': 'Leukemia'}]",5.0,0.28117,"We are currently conducting a randomized, placebo-controlled trial of prednisolone for the treatment of Bell's palsy in children within the Paediatric Research in Emergency Departments International Collaborative emergency research network.","[{'ForeName': 'Franz E', 'Initials': 'FE', 'LastName': 'Babl', 'Affiliation': ""Emergency Department, Royal Children's Hospital, and Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Victoria, Australia; Paediatric Research in Emergency Departments International Collaborative (PREDICT), Melbourne, Australia. Electronic address: franz.babl@rch.org.au.""}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Kochar', 'Affiliation': ""Paediatric Research in Emergency Departments International Collaborative (PREDICT), Melbourne, Australia; Emergency Department, Women's and Children's Hospital, Adelaide, Australia.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Osborn', 'Affiliation': ""Department of Haematology and Oncology, Women's and Children's Hospital, North Adelaide, South Australia, Australia.""}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Borland', 'Affiliation': ""Paediatric Research in Emergency Departments International Collaborative (PREDICT), Melbourne, Australia; Emergency Department, Perth Children's Hospital, and the Divisions of Emergency Medicine, Faculty of Health and Medical Sciences, University of Western Australia, Perth, Australia.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'West', 'Affiliation': ""Paediatric Research in Emergency Departments International Collaborative (PREDICT), Melbourne, Australia; Monash Emergency Research Collaborative, School of Clinical Sciences at Monash Health, Monash University, and the Paediatric Emergency Department, Monash Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': ""Emergency Department, Royal Children's Hospital, and Murdoch Children's Research Institute, Parkville, Victoria, Australia; Paediatric Research in Emergency Departments International Collaborative (PREDICT), Melbourne, Australia.""}, {'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Dalziel', 'Affiliation': ""Paediatric Research in Emergency Departments International Collaborative (PREDICT), Melbourne, Australia; Emergency Department, Starship Children's Hospital, and the Departments of Surgery and Paediatrics, Child and Youth Health, University of Auckland, Auckland, New Zealand.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of emergency medicine,['10.1016/j.annemergmed.2020.06.029']
2306,32788083,The utility of a computerised clinical decision support system intervention in home medicines review: A mixed-methods process evaluation.,"BACKGROUND


Use of high-risk medications is common and associated with adverse effects in older adults, including those living with dementia. A Computerised Clinical Decision Support System (CCDSS) called G-MEDSS© (Goal-directed Medication Review Electronic Decision Support System) contains tools that identify medications with anticholinergic and sedative effects and align older adult's health and medication goals of care with medication management strategies.
OBJECTIVES


To describe the utility of a CCDSS called G-MEDSS in Home Medicines Review (HMR) by an accredited clinical pharmacist (ACP) using a mixed-methods process evaluation method.
METHODS


A mixed-methods process evaluation was conducted as part of a nation-wide cluster-randomised clinical trial evaluating the effectiveness of implementing G-MEDSS in HMR. Data were collected from ACPs and HMR recipients (the patient) using a feedback survey (ACPs and HMR recipients) and one-on-one telephone interviews (HMR recipients). Quantitative and qualitative data were combined at the start of analysis. Content analysis of the qualitative data was conducted, and emerging categories were linked to quantitative data.
RESULTS


Feedback surveys were completed by eight ACPs and 26 HMR recipients; 11 HMR recipients completed one-on-one telephone interviews. Overall, ACPs and HMR recipients who received the intervention reported a positive attitude towards the utility of G-MEDSS in HMR. ACPs reported that G-MEDSS enhanced their ability to make evidence-based recommendations about anticholinergic and sedative medications, and to better align HMR recommendations with HMR recipients' goals of care. However, ACPs described that it was difficult to obtain goals of care from HMR recipients. HMR recipients gave mixed reports about the ACPs consultations: some HMR recipients reported that they were engaged in discussions about their views on medications, whilst other participants reported that discussions about their concerns towards medications and goals was limited.
CONCLUSIONS


This study suggests that a CCDSS, such as G-MEDSS, demonstrates good utility to assist ACPs to identify and assess anticholinergic and sedative medications. Given the mixed feedback from the ACPs on the different components of the G-MEDSS, further refinement of these tools and their use in combination in practice may be needed.",2020,"Overall, ACPs and HMR recipients who received the intervention reported a positive attitude towards the utility of G-MEDSS in HMR.",['older adults'],"['implementing G-MEDSS', 'computerised clinical decision support system intervention', 'CCDSS called G-MEDSS', 'G-MEDSS', 'HMR']",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0525070', 'cui_str': 'Clinical Decision Support Systems'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0282443', 'cui_str': 'Review'}]",[],,0.0632004,"Overall, ACPs and HMR recipients who received the intervention reported a positive attitude towards the utility of G-MEDSS in HMR.","[{'ForeName': 'Mouna', 'Initials': 'M', 'LastName': 'Sawan', 'Affiliation': 'NHMRC Cognitive Decline Partnership Centre, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, NSW, Australia; School of Pharmacy School, Faculty of Medicine and Health, Sydney University, New South Wales, Australia; Clinical Pharmacology and Aged Care, Kolling Institute of Medical Research, Royal North Shore Hospital, New South Wales, Australia. Electronic address: mouna.sawan@sydney.edu.au.'}, {'ForeName': 'Lisa Kouladjian', 'Initials': 'LK', 'LastName': ""O'Donnell"", 'Affiliation': 'NHMRC Cognitive Decline Partnership Centre, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, NSW, Australia; School of Pharmacy School, Faculty of Medicine and Health, Sydney University, New South Wales, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Reeve', 'Affiliation': 'NHMRC Cognitive Decline Partnership Centre, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, NSW, Australia; Quality Use of Medicines and Pharmacy Research Centre, School of Pharmacy and Medical Sciences, Division of Health Sciences, University of South Australia, South Australia, Australia; Geriatric Medicine Research, Faculty of Medicine, College of Pharmacy, Dalhousie University and Nova Scotia Health Authority, Halifax, Canada.'}, {'ForeName': 'Danijela', 'Initials': 'D', 'LastName': 'Gnjidic', 'Affiliation': 'School of Pharmacy School, Faculty of Medicine and Health, Sydney University, New South Wales, Australia; Charles Perkins Centre, The University of Sydney, Australia.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Chen', 'Affiliation': 'Clinical Pharmacology and Aged Care, Kolling Institute of Medical Research, Royal North Shore Hospital, New South Wales, Australia.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Kelly', 'Affiliation': 'School of Public Health, Faculty of Medicine and Health, The University of Sydney, New South Wales, Australia.'}, {'ForeName': 'J Simon', 'Initials': 'JS', 'LastName': 'Bell', 'Affiliation': 'NHMRC Cognitive Decline Partnership Centre, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, NSW, Australia; Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Victoria, Australia; School of Public Health and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Victoria, Australia.'}, {'ForeName': 'Sarah N', 'Initials': 'SN', 'LastName': 'Hilmer', 'Affiliation': 'NHMRC Cognitive Decline Partnership Centre, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, NSW, Australia; Clinical Pharmacology and Aged Care, Kolling Institute of Medical Research, Royal North Shore Hospital, New South Wales, Australia.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2020.06.010']
2307,32788120,Impact of implementation of an individualised thromboprophylaxis protocol in critically ill ICU patients with COVID-19: A longitudinal controlled before-after study.,"INTRODUCTION


An individualised thromboprophylaxis was implemented in critically ill patients suffering from coronavirus disease 2019 (COVID-19) pneumonia to reduce mortality and improve clinical outcome. The aim of this study was to evaluate the effect of this intervention on clinical outcome.
METHODS


In this mono-centric, controlled, before-after study, all consecutive adult patients with confirmed COVID-19 pneumonia admitted to ICU from March 13th to April 20th 2020 were included. A thromboprophylaxis protocol, including augmented LMWH dosing, individually tailored with anti-Xa measurements and twice-weekly ultrasonography screening for DVT, was implemented on March 31th 2020. Primary endpoint is one-month mortality. Secondary outcomes include two-week and three-week mortality, the incidence of VTE, acute kidney injury and continuous renal replacement therapy (CRRT). Multiple regression modelling was used to correct for differences between the two groups.
RESULTS


46 patients were included in the before group, 26 patients in the after group. One month mortality decreased from 39.13% to 3.85% (p < 0.001). After correction for confounding variables, one-month mortality was significantly higher in the before group (p = 0.02, OR 8.86 (1.46, 53.75)). The cumulative incidence of VTE and CRRT was respectively 41% and 30.4% in the before group and dropped to 15% (p = 0.03) and 3.8% (p = 0.01), respectively. After correction for confounding variables, risk of VTE (p = 0.03, 6.01 (1.13, 32.12)) and CRRT (p = 0.02, OR 19.21 (1.44, 255.86)) remained significantly higher in the before group.
CONCLUSION


Mortality, cumulative risk of VTE and need for CRRT may be significantly reduced in COVID-19 patients by implementation of a more aggressive thromboprophylaxis protocol. Future research should focus on confirmation of these results in a randomized design and on uncovering the mechanisms underlying these observations.
REGISTRATION NUMBER


NCT04394000.",2020,"After correction for confounding variables, one-month mortality was significantly higher in the before group (p = 0.02, OR 8.86 (1.46, 53.75)).","['critically ill ICU patients with COVID-19', 'critically ill patients suffering from coronavirus disease 2019 (COVID-19) pneumonia', '46 patients were included in the before group, 26 patients in the after group', 'consecutive adult patients with confirmed COVID-19 pneumonia admitted to ICU from March 13th to April 20th 2020 were included']","['LMWH dosing, individually tailored with anti-Xa measurements and twice-weekly ultrasonography screening for DVT', 'individualised thromboprophylaxis protocol']","['week mortality, the incidence of VTE, acute kidney injury and continuous renal replacement therapy (CRRT', 'mortality', 'month mortality', 'cumulative incidence of VTE and CRRT', 'Mortality, cumulative risk of VTE and need for CRRT', 'CRRT']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}]",46.0,0.053393,"After correction for confounding variables, one-month mortality was significantly higher in the before group (p = 0.02, OR 8.86 (1.46, 53.75)).","[{'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Stessel', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium; UHasselt, Faculty of Medicine and Life Sciences, LCRC, Agoralaan, 3590 Diepenbeek, Belgium. Electronic address: bjorn.stessel@jessazh.be.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Vanvuchelen', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Bruckers', 'Affiliation': 'I-BioStat, Data Science Institute, Hasselt University, Martelarenlaan 42, 3500 Hasselt, Belgium.'}, {'ForeName': 'Laurien', 'Initials': 'L', 'LastName': 'Geebelen', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Ina', 'Initials': 'I', 'LastName': 'Callebaut', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium; UHasselt, Faculty of Medicine and Life Sciences, LCRC, Agoralaan, 3590 Diepenbeek, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Vandenbrande', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Pellens', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Van Tornout', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Ory', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Karlijn', 'Initials': 'K', 'LastName': 'van Halem', 'Affiliation': 'Department of Infectious Diseases and Immunity, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Messiaen', 'Affiliation': 'UHasselt, Faculty of Medicine and Life Sciences, LCRC, Agoralaan, 3590 Diepenbeek, Belgium; Department of Infectious Diseases and Immunity, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Lieven', 'Initials': 'L', 'LastName': 'Herbots', 'Affiliation': 'Department of Cardiology and Coronary Care Unit, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Ramaekers', 'Affiliation': 'Chief Medical Officer, Jessa Hospital, Hasselt, Belgium; Leuven Institute for Healthcare Policy (LIHP), University of Leuven, Belgium.'}, {'ForeName': 'Jasperina', 'Initials': 'J', 'LastName': 'Dubois', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}]",Thrombosis research,['10.1016/j.thromres.2020.07.038']
2308,32788139,"Cost-effectiveness of SMS appointment reminders in increasing vaccination uptake in Lagos, Nigeria: A multi-centered randomized controlled trial.","OBJECTIVE


It is expected that mHealth largely contribute to increasing the coverages of key maternal and child health services. This study aims to estimate the cost-effectiveness of the SMS text reminders in clients' return visits to the health facilities for child vaccinations (incl. vitamin A supplementations), antenatal care (ANC) and family planning (FP), in urban communities of Lagos, Nigeria.
METHODS


A multi-centered randomized control trial was conducted at 33 primary health centers (PHCs) in Lagos, Nigeria. All the clients having visited any of the 33 PHCs for child vaccinations, ANC and FP were randomly assigned either to intervention group or to control group. The participants in the intervention group were sent an SMS text reminder two days before their appointments. Those not having showed up on the appointment dates received an additional SMS text reminder seven days after original appointment dates as defaulter tracing. The primary outcome was whether a client made return visit to PHCs for the upcoming appointments.
RESULTS


Of 12,779 appointments for 9,368 clients during the period of 1stApril to 30thJune 2019, 12,175 were included in the analysis. The return rate for child vaccinations in the intervention group was significantly higher (p < 0.001) by 4.8% - 6.0% than that in the control group, consistently across all the five different timings (on time as scheduled, and by 7 days, 14 days, 30 days, and 3 months after appointment dates). No significant difference between the two groups was detected in the increase in return rates for ANC and FP services. The incremental recurrent cost was estimated at 7.90 US Dollars per return case.
CONCLUSION


SMS text reminders led to a significant increase in the number of return visits for child vaccinations, Lagos, Nigeria, while no significant increase in return visits was confirmed for ANC and FP appointments.",2020,"The return rate for child vaccinations in the intervention group was significantly higher (p < 0.001) by 4.8% - 6.0% than that in the control group, consistently across all the five different timings (on time as scheduled, and by 7 days, 14 days, 30 days, and 3 months after appointment dates).","['clients having visited any of the 33 PHCs for child vaccinations, ANC and FP', '33 primary health centers (PHCs) in Lagos, Nigeria', 'urban communities of Lagos, Nigeria', 'Lagos, Nigeria', 'Of 12,779 appointments for 9,368 clients during the period of 1stApril to 30thJune 2019', ""clients' return visits to the health facilities for child vaccinations (incl""]","['vitamin A supplementations), antenatal care (ANC) and family planning (FP', 'SMS text reminders', 'SMS appointment reminders']","['return rate for child vaccinations', 'return visits', 'incremental recurrent cost', 'return rates for ANC and FP services', 'cost-effectiveness', 'client made return visit to PHCs for the upcoming appointments', 'number of return visits']","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0268281', 'cui_str': 'Infantile neuronal ceroid lipofuscinosis'}]","[{'cui': 'C4524019', 'cui_str': 'Vitamin A supplementation'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.0378836,"The return rate for child vaccinations in the intervention group was significantly higher (p < 0.001) by 4.8% - 6.0% than that in the control group, consistently across all the five different timings (on time as scheduled, and by 7 days, 14 days, 30 days, and 3 months after appointment dates).","[{'ForeName': 'Yoshito', 'Initials': 'Y', 'LastName': 'Kawakatsu', 'Affiliation': 'Department of Global Health, University of Washington, USA. Electronic address: yoshitok@uw.edu.'}, {'ForeName': 'Adefunke', 'Initials': 'A', 'LastName': 'Oyeniyi Adesina', 'Affiliation': 'Lagos State Ministry of Health, Lagos, Nigeria.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Kadoi', 'Affiliation': 'Project for Strengthening Pro-poor Community Health Services in Lagos State, Nigeria.'}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Aiga', 'Affiliation': 'School of Tropical Medicine and Global Health, Nagasaki University, Nagasaki, Japan.'}]",Vaccine,['10.1016/j.vaccine.2020.07.075']
2309,32785210,"Effect of 2 Different Dosages of Rosuvastatin on Prognosis of Acute Myocardial Infarction Patients with New-Onset Atrial Fibrillation in Jinan, China.","BACKGROUND Atrial fibrillation (AF) often occurs in patients with acute myocardial infarction (AMI). This study aimed to observe the influence of different dosages of rosuvastatin on the prognosis of AMI patients with AF. MATERIAL AND METHODS We performed an observational, retrospective cohort study in Jinan, China, in which 323 AMI patients were recruited. All patients were randomized to receive optimal medication treatment and 10 mg or 20 mg of rosuvastatin. Holter monitor results, serum lipid levels, and heart function were recorded. We used multivariate Cox and Kaplan-Meier analyses to assess the independent factors and differences in AF and ischemia events and safety of rosuvastatin administered at different dosages. RESULTS TC, LDL-C, and TG at 1 and 12 months were significantly lower compared with those observed prior to treatment in both groups. The heart function of both groups was significantly improved after 12 months of treatment, especially in the 20 mg group. Multivariate Cox analysis showed that different dosages of rosuvastatin, age, smoking, drinking alcohol, and diabetes are independent factors related to the occurrence of AF and ischemic events. In addition, according to Kaplan-Meier analysis, no significant difference in adverse clinical events existed at different dosages of rosuvastatin. CONCLUSIONS Treatment with rosuvastatin can reduce the serum lipid level and improve cardiac function. Different dosages of rosuvastatin, age, smoking, drinking alcohol, and diabetes are independent risk factors for AF and ischemia events. The results suggested it is safe to use 20 mg rosuvastatin in the 12 months after hospital admission.",2020,"The heart function of both groups was significantly improved after 12 months of treatment, especially in the 20 mg group.","['Jinan, China, in which 323 AMI patients were recruited', 'Acute Myocardial Infarction Patients with New-Onset Atrial Fibrillation in Jinan, China', 'AMI patients with AF', 'patients with acute myocardial infarction (AMI']","['rosuvastatin', 'optimal medication treatment and 10 mg or 20 mg of rosuvastatin', 'Rosuvastatin']","['adverse clinical events', 'serum lipid levels, and heart function', 'serum lipid level and improve cardiac function', 'heart function', 'AF and ischemia events and safety', 'TC, LDL-C, and TG']","[{'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]",323.0,0.0112626,"The heart function of both groups was significantly improved after 12 months of treatment, especially in the 20 mg group.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, School of Public Health, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China (mainland).'}, {'ForeName': 'Ruiqi', 'Initials': 'R', 'LastName': 'Feng', 'Affiliation': 'Department of Physiology and Biophysics, University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': 'Misbahul', 'Initials': 'M', 'LastName': 'Ferdous', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, Beijing, China (mainland).'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, Shandong Provincial Hospital affiliated to Shandong First Medical University, Jinan, Shandong, China (mainland).'}, {'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'Department of Cardiology, Shandong Provincial Hospital affiliated to Shandong First Medical University, Jinan, Shandong, China (mainland).'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, Shandong Provincial Hospital affiliated to Shandong First Medical University, Jinan, Shandong, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.925666']
2310,32785213,Phase 1/2 study of COVID-19 RNA vaccine BNT162b1 in adults.,"In March 2020, the World Health Organization (WHO) declared a pandemic of coronavirus disease 2019 (COVID-19), due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 1 . With rapidly accumulating cases and deaths reported globally 2 , a vaccine is urgently needed. We report the available safety, tolerability, and immunogenicity data from an ongoing placebo-controlled, observer-blinded dose escalation study among 45 healthy adults, 18 to 55 years of age, randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein receptor-binding domain (RBD). Local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. A second vaccination with 100 µg was not administered due to increased reactogenicity and a lack of meaningfully increased immunogenicity after a single dose compared to the 30 μg dose. RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titers in sera increased with dose level and after a second dose. Geometric mean neutralizing titers reached 1.9- to 4.6-fold that of a panel of COVID-19 convalescent human sera at least 14 days after a positive SARS-CoV-2 PCR. These results support further evaluation of this mRNA vaccine candidate. (ClinicalTrials.gov identifier: NCT04368728).",2020,RBD-binding IgG concentrations and SARS-CoV-2,"['45 healthy adults, 18 to 55 years of age', 'adults']","['COVID-19 RNA vaccine BNT162b1', 'lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein receptor-binding domain (RBD']","['Geometric mean neutralizing titers', 'Local reactions and systemic events', 'RBD-binding IgG concentrations and SARS-CoV-2', 'reactogenicity', 'neutralizing titers']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0028621', 'cui_str': 'Nucleoside'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0853813', 'cui_str': 'Local reaction'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]",45.0,0.183612,RBD-binding IgG concentrations and SARS-CoV-2,"[{'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Mulligan', 'Affiliation': 'New York University Langone Vaccine Center, New York, NY, USA.'}, {'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Lyke', 'Affiliation': 'University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore, MD, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Kitchin', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Hurley, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Absalon', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA. judith.absalon@pfizer.com.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Gurtman', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lockhart', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Hurley, UK.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Neuzil', 'Affiliation': 'University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore, MD, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Raabe', 'Affiliation': 'New York University Langone Vaccine Center, New York, NY, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Bailey', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Hurley, UK.'}, {'ForeName': 'Kena A', 'Initials': 'KA', 'LastName': 'Swanson', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Koury', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Kalina', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cooper', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Fontes-Garfias', 'Affiliation': 'University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Pei-Yong', 'Initials': 'PY', 'LastName': 'Shi', 'Affiliation': 'University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Türeci', 'Affiliation': 'BioNTech, Mainz, Germany.'}, {'ForeName': 'Kristin R', 'Initials': 'KR', 'LastName': 'Tompkins', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Edward E', 'Initials': 'EE', 'LastName': 'Walsh', 'Affiliation': 'University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Frenck', 'Affiliation': ""Cincinnati Children's Hospital, Cincinnati, OH, USA.""}, {'ForeName': 'Ann R', 'Initials': 'AR', 'LastName': 'Falsey', 'Affiliation': 'University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Dormitzer', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Gruber', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Uğur', 'Initials': 'U', 'LastName': 'Şahin', 'Affiliation': 'BioNTech, Mainz, Germany.'}, {'ForeName': 'Kathrin U', 'Initials': 'KU', 'LastName': 'Jansen', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}]",Nature,['10.1038/s41586-020-2639-4']
2311,32785245,Impact of an acceptance facilitating intervention on psychotherapists' acceptance of blended therapy.,"Blended therapy is a new approach combining advantages of face-to-face psychotherapy and Internet- and mobile-based interventions. Acceptance is a fundamental precondition for its implementation. The aim of this study was to assess 1) the acceptance of psychotherapists towards blended therapy, 2) the effectiveness of an acceptance facilitating intervention (AFI) on psychotherapists' acceptance towards blended therapy and 3) to identify potential effect moderators. Psychotherapists (N = 284) were randomly assigned to a control (CG) or an intervention group (IG). The IG received a short video showing an example of blended therapy, the CG an attention placebo video. Both groups received a reliable online questionnaire assessing acceptance, effort expectancy, performance expectancy, facilitating conditions, social influence and internet anxiety. Between group differences were examined using t-tests and Mann-Whitney tests. Exploratory analysis was conducted to identify moderators. Psychotherapists in CG showed mixed baseline acceptance towards blended therapy (low = 40%, moderate = 33%, high = 27%). IG showed significantly higher acceptance compared to CG (d = .27, pone-sided = .029; low = 24%, moderate = 47%, high = 30%). Bootstrapped confidence intervals were overlapping. Performance expectancy (d = .35), effort expectancy (d = .44) and facilitating conditions (d = .28) were significantly increased (p < .05). No effects on social influence and internet anxiety were found (p>.05). Exploratory analysis indicated psychodynamic oriented psychotherapists profiting particularly from the AFI. Blended therapy is a promising approach to improve healthcare. Psychotherapists show mixed acceptance, which might be improvable by AFIs, particularly in subpopulations of initially rather skeptical psychotherapists. Forthcoming studies should extend the present study by shifting focus from attitudes to the impact of different forms of AFIs on uptake.",2020,"IG showed significantly higher acceptance compared to CG (d = .27, pone-sided = .029; low = 24%, moderate = 47%, high = 30%).",['Psychotherapists (N = 284'],"['control (CG', 'acceptance facilitating intervention (AFI', 'acceptance facilitating intervention']","['social influence and internet anxiety', 'effort expectancy', 'Performance expectancy', 'reliable online questionnaire assessing acceptance, effort expectancy, performance expectancy, facilitating conditions, social influence and internet anxiety']","[{'cui': 'C0557555', 'cui_str': 'Psychotherapist'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",284.0,0.0280326,"IG showed significantly higher acceptance compared to CG (d = .27, pone-sided = .029; low = 24%, moderate = 47%, high = 30%).","[{'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Baumeister', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Yannik', 'Initials': 'Y', 'LastName': 'Terhorst', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Cora', 'Initials': 'C', 'LastName': 'Grässle', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Freudenstein', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Nübling', 'Affiliation': 'Chamber of Psychotherapists Baden-Württemberg, Stuttgart, Germany.'}, {'ForeName': 'David Daniel', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Faculty of Behavioural and Movement Sciences, Clinical, Neuro- & Developmental Psychology, VU Amsterdam, Amsterdam, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0236995']
2312,32785281,The impact of structured sleep schedules prior to an in-laboratory study: Individual differences in sleep and circadian timing.,"INTRODUCTION


Many sleep and circadian studies require participants to adhere to structured sleep-wake schedules designed to stabilize sleep outcomes and circadian phase prior to in-laboratory testing. The effectiveness of this approach has not been rigorously evaluated, however. We therefore investigated the differences between participants' unstructured and structured sleep over a three-week interval.
METHODS


Twenty-three healthy young adults completed three weeks of sleep monitoring, including one week of unstructured sleep and two weeks of structured sleep with consistent bed and wake times. Circadian phase was assessed via salivary dim light melatonin onset (DLMO) during both the unstructured and structured sleep episodes.
RESULTS


Compared to their unstructured sleep schedule, participants' bed- and wake times were significantly earlier in their structured sleep, by 34 ± 44 mins (M ± SD) and 44 ± 41 mins, respectively. During structured sleep, circadian phase was earlier in 65% of participants (40 ± 32 mins) and was later in 35% (41 ± 25 mins) compared to unstructured sleep but did not change at the group level. While structured sleep reduced night-to-night variability in sleep timing and sleep duration, and improved the alignment (phase angle) between sleep onset and circadian phase in the most poorly aligned individuals (DLMO < 1h or > 3h before sleep onset time; 25% of our sample), sleep duration and quality were unchanged.
CONCLUSION


Our results show adherence to a structured sleep schedule results in more regular sleep timing, and improved alignment between sleep and circadian timing for those individuals who previously had poorer alignment. Our findings support the use of structured sleep schedules prior to in-laboratory sleep and circadian studies to stabilize sleep and circadian timing in healthy volunteers.",2020,"During structured sleep, circadian phase was earlier in 65% of participants (40 ± 32 mins) and was later in 35% (41 ± 25 mins) compared to unstructured sleep but did not change at the group level.","['healthy volunteers', 'Twenty-three healthy young adults']",[],['sleep duration and quality'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]",[],"[{'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",23.0,0.0294388,"During structured sleep, circadian phase was earlier in 65% of participants (40 ± 32 mins) and was later in 35% (41 ± 25 mins) compared to unstructured sleep but did not change at the group level.","[{'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'McMahon', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Ftouni', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew J K', 'Initials': 'AJK', 'LastName': 'Phillips', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Beatty', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Lockley', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Shanthakumar M W', 'Initials': 'SMW', 'LastName': 'Rajaratnam', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Maruff', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sean P A', 'Initials': 'SPA', 'LastName': 'Drummond', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Anderson', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}]",PloS one,['10.1371/journal.pone.0236566']
2313,32785495,High-intensity Interval Training versus Continuous Exercise: Is There a Difference Regarding the Magnitude of Blood Pressure Reduction?,,2020,,[],['High-intensity Interval Training versus Continuous Exercise'],[],[],"[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",[],,0.0286429,,"[{'ForeName': 'Filipe', 'Initials': 'F', 'LastName': 'Ferrari', 'Affiliation': 'Programa de Pós-Graduação em Cardiologia e Ciências Cardiovasculares, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brasil.'}, {'ForeName': 'Vítor Magnus', 'Initials': 'VM', 'LastName': 'Martins', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brasil.'}]",Arquivos brasileiros de cardiologia,['10.36660/abc.20200261']
2314,32785514,ERRATUM: Patient safety: within the reach of the homeless?,,2020,,[],[],[],[],[],[],,0.0221623,,[],Revista brasileira de enfermagem,['10.1590/0034-7167.202073n6e10']
2315,32785516,Palliative care consultation team: symptom relief in first 48 hours of hospitalization.,"OBJECTIVE


To compare the relief of symptoms provided by palliative care consultation team (PCCT) compared to the traditional care team (TC), in patients with advanced cancer in the first 48 hours of hospitalization.
METHOD


Allocated to PCCT Group and TC Group, this study assessed 290 patients according to the Edmonton Symptom Assessment System (ESAS) within the first 48 hours of hospitalization. The main outcome was a minimum 2-point reduction in symptom intensity.
RESULTS


At 48 hours, the PCCT Group had a 2-point reduction in the mean differences (p <0.001) in pain, nausea, dyspnea, and depression; and TC Group, on nausea and sleep impairment (p <0.001). Multiple Logistic Regression found for the PCCT Group a greater chance of pain relief (OR 2.34; CI 1.01-5.43; p = 0.049).
CONCLUSION


There was superiority of the PCCT Group for pain relief, dyspnea and depression. There is a need for more studies that broaden the understanding of team modalities.",2020,"Multiple Logistic Regression found for the PCCT Group a greater chance of pain relief (OR 2.34; CI 1.01-5.43; p = 0.049).
","['patients with advanced cancer in the first 48 hours of hospitalization', '290 patients according to the Edmonton Symptom Assessment System (ESAS) within the first 48 hours of hospitalization']","['TC Group', 'palliative care consultation team (PCCT', 'PCCT', 'traditional care team (TC']","['pain relief', 'pain, nausea, dyspnea, and depression', 'pain relief, dyspnea and depression', 'nausea and sleep impairment', 'minimum 2-point reduction in symptom intensity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C3472649', 'cui_str': 'Edmonton symptom assessment system'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",290.0,0.0458744,"Multiple Logistic Regression found for the PCCT Group a greater chance of pain relief (OR 2.34; CI 1.01-5.43; p = 0.049).
","[{'ForeName': 'Magda Aparecida Dos Santos', 'Initials': 'MADS', 'LastName': 'Silva', 'Affiliation': 'Universidade Paulista, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Marcio Augusto', 'Initials': 'MA', 'LastName': 'Diniz', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California, United States of America.'}, {'ForeName': 'Ricardo Tavares de', 'Initials': 'RT', 'LastName': 'Carvalho', 'Affiliation': 'Hospital das Clínicas, Universidade de São Paulo, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Chiba', 'Affiliation': 'Instituto do Câncer do Estado de São Paulo - Octávio Mário Frias de Oliveira, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cibele Andrucioli de', 'Initials': 'CA', 'LastName': 'Mattos-Pimenta', 'Affiliation': 'Universidade de São Paulo, São Paulo, São Paulo, Brazil.'}]",Revista brasileira de enfermagem,['10.1590/0034-7167-2019-0391']
2316,32785709,Safety and Efficacy of Rifampin or Isoniazid Among People with Mycobacterium tuberculosis Infection and Living with HIV or Other Health Conditions: Post-Hoc Analysis of Two Randomized Trials.,"BACKGROUND


Data on the safety and efficacy of rifampin among people living with HIV or other health conditions has not been reported. We assessed completion, safety, and efficacy of four-months of rifampin vs nine-months of isoniazid among people living with HIV or other health conditions.
METHODS


We conducted post-hoc analysis of two randomized trials including 6859 adult participants with Mycobacterium tuberculosis infection. Participants were randomized 1:1 to 10 mg/kg/d rifampin or 5 mg/kg/d isoniazid. We report completion, drug-related adverse events, and active tuberculosis incidence among people 1) living with HIV; 2) with renal failure or receiving immunosuppressants; 3) using drugs or with hepatitis; 4) with diabetes mellitus; 5) consuming >1 alcoholic drink per week or current/former smokers; 6) with no health condition.
RESULTS


Overall, 270 (3.9%) people were living with HIV (135 receiving ART), 2012 (29.3%) had another health condition, and 4577 (66.8%) had no condition. Rifampin was more often or similarly completed to isoniazid in all populations. Drug-related adverse events were less common with rifampin than isoniazid among people living with HIV (risk difference: -2.1%, 95%CI -5.9 to 1.6). This was consistent for others except people with renal failure or on immunosuppressants (2.1%, 95%CI -7.2 to 11.3). Tuberculosis incidence was similar among people receiving rifampin or isoniazid. Among participants receiving rifampin living with HIV, incidence was comparable to those with no health condition (rate difference: 4.1 per 1000 person-years, 95%CI -6.4 to 14.7).
CONCLUSIONS


Rifampin appears to be safe and as effective as isoniazid across many populations with health conditions, including HIV.",2020,"Drug-related adverse events were less common with rifampin than isoniazid among people living with HIV (risk difference: -2.1%, 95%CI -5.9 to 1.6).","['people 1) living with HIV; 2) with renal failure or receiving immunosuppressants; 3) using drugs or with hepatitis; 4) with diabetes mellitus', '6859 adult participants with Mycobacterium tuberculosis infection', 'People with Mycobacterium tuberculosis Infection and Living with HIV or Other Health Conditions', 'people living with HIV or other health conditions']","['Rifampin', 'rifampin or isoniazid', 'alcoholic drink per week or current/former smokers; 6) with no health condition', 'isoniazid', 'Rifampin or Isoniazid', 'rifampin or 5 mg/kg/d isoniazid', 'rifampin']","['Tuberculosis incidence', 'Safety and Efficacy', 'completion, safety, and efficacy']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0019158', 'cui_str': 'Inflammatory disease of liver'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}]","[{'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",6859.0,0.484171,"Drug-related adverse events were less common with rifampin than isoniazid among people living with HIV (risk difference: -2.1%, 95%CI -5.9 to 1.6).","[{'ForeName': 'Jonathon R', 'Initials': 'JR', 'LastName': 'Campbell', 'Affiliation': 'Faculty of Medicine, McGill University, Montreal, Canada.'}, {'ForeName': 'Hamdan', 'Initials': 'H', 'LastName': 'Al-Jahdali', 'Affiliation': 'King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Boubacar', 'Initials': 'B', 'LastName': 'Bah', 'Affiliation': 'Université Gamal Abdel Nasser de Conakry, Conakry, Guinea.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Belo', 'Affiliation': 'State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Victoria J', 'Initials': 'VJ', 'LastName': 'Cook', 'Affiliation': 'British Columbia Centre for Disease Control, Vancouver, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Long', 'Affiliation': 'University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Schwartzman', 'Affiliation': 'Faculty of Medicine, McGill University, Montreal, Canada.'}, {'ForeName': 'Anete', 'Initials': 'A', 'LastName': 'Trajman', 'Affiliation': 'Faculty of Medicine, McGill University, Montreal, Canada.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'Menzies', 'Affiliation': 'Faculty of Medicine, McGill University, Montreal, Canada.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1169']
2317,32785710,"Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With COVID-19 (Metcovid): A Randomised, Double-Blind, Phase IIb, Placebo-Controlled Trial.","BACKGROUND


Steroid use for COVID-19 is based on the possible role of these drugs in mitigating the inflammatory response, mainly in the lungs, triggered by SARS-CoV-2. This study aimed at evaluating at evaluating the efficacy of methylprednisolone (MP) among hospitalized patients with suspected COVID-19.
METHODS


Parallel, double-blind, placebo-controlled, randomized, phase IIb clinical trial was performed with hospitalized patients aged ≥ 18 years with clinical, epidemiological and/or radiological suspected COVID-19, at a tertiary care facility in Manaus, Brazil. Patients were randomly allocated (1:1 ratio) to receive either intravenous MP (0.5 mg/kg) or placebo (saline solution), twice daily, for 5 days. A modified intention-to-treat (mITT) analysis was conducted. The primary outcome was 28-day mortality. ClinicalTrials Identifier NCT04343729.
FINDINGS


From April 18 to June 16, 2020, 647 patients were screened, 416 randomized, and 393 analyzed as mITT, MP in 194 and placebo in 199 individuals. SARS-CoV-2 infection was confirmed by RT-PCR in 81.3%. Mortality at day 28 was not different between groups. A subgroup analysis showed that patients over 60 years in the MP group had a lower mortality rate at day 28. Patients in the MP arm tended to need more insulin therapy, and no difference was seen in virus clearance in respiratory secretion until day 7.
CONCLUSION


The findings of this study suggest that a short course of MP in hospitalized patients with COVID-19 did not reduce mortality in the overall population.",2020,"Patients in the MP arm tended to need more insulin therapy, and no difference was seen in virus clearance in respiratory secretion until day 7.
","['Patients Hospitalized With COVID-19 (Metcovid', 'hospitalized patients with suspected COVID-19', 'From April 18 to June 16, 2020, 647 patients were screened, 416 randomized, and 393 analyzed as mITT, MP in 194 and placebo in 199 individuals', 'hospitalized patients aged ≥ 18 years with clinical, epidemiological and/or radiological suspected COVID-19, at a tertiary care facility in Manaus, Brazil']","['Placebo', 'intravenous MP', 'methylprednisolone (MP', 'placebo (saline solution', 'Methylprednisolone', 'placebo']","['28-day mortality', 'mortality rate', 'virus clearance in respiratory secretion', 'mortality', 'Mortality', 'SARS-CoV-2 infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517754', 'cui_str': '393'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C1532372', 'cui_str': 'Respiratory secretion'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",647.0,0.771386,"Patients in the MP arm tended to need more insulin therapy, and no difference was seen in virus clearance in respiratory secretion until day 7.
","[{'ForeName': 'Christiane Maria Prado', 'Initials': 'CMP', 'LastName': 'Jeronimo', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Maria Eduarda Leão', 'Initials': 'MEL', 'LastName': 'Farias', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Fernando Fonseca Almeida', 'Initials': 'FFA', 'LastName': 'Val', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Vanderson Souza', 'Initials': 'VS', 'LastName': 'Sampaio', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Marcia Almeida Araújo', 'Initials': 'MAA', 'LastName': 'Alexandre', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Gisely Cardoso', 'Initials': 'GC', 'LastName': 'Melo', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Izabella Picinin', 'Initials': 'IP', 'LastName': 'Safe', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Mayla Gabriela Silva', 'Initials': 'MGS', 'LastName': 'Borba', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Rebeca Linhares', 'Initials': 'RL', 'LastName': 'Abreu-Netto', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Alex Bezerra Silva', 'Initials': 'ABS', 'LastName': 'Maciel', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'João Ricardo Silva', 'Initials': 'JRS', 'LastName': 'Neto', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Lucas Barbosa', 'Initials': 'LB', 'LastName': 'Oliveira', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Erick Frota Gomes', 'Initials': 'EFG', 'LastName': 'Figueiredo', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Kelry Mazurega Oliveira', 'Initials': 'KMO', 'LastName': 'Dinelly', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Maria Gabriela de Almeida', 'Initials': 'MGA', 'LastName': 'Rodrigues', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Brito', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Maria Paula Gomes', 'Initials': 'MPG', 'LastName': 'Mourão', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Guilherme Augusto', 'Initials': 'GA', 'LastName': 'Pivoto João', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Ludhmila Abrahão', 'Initials': 'LA', 'LastName': 'Hajjar', 'Affiliation': 'Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Quique', 'Initials': 'Q', 'LastName': 'Bassat', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Gustavo Adolfo Sierra', 'Initials': 'GAS', 'LastName': 'Romero', 'Affiliation': 'Núcleo de Medicina Tropical, Universidade de Brasília.'}, {'ForeName': 'Felipe Gomes', 'Initials': 'FG', 'LastName': 'Naveca', 'Affiliation': 'Instituto Leônidas & Maria Deane, Fiocruz Amazonas, Manaus, Brazil.'}, {'ForeName': 'Heline Lira', 'Initials': 'HL', 'LastName': 'Vasconcelos', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Michel de Araújo', 'Initials': 'MA', 'LastName': 'Tavares', 'Affiliation': 'Universidade Federal do Amazonas.'}, {'ForeName': 'José Diego', 'Initials': 'JD', 'LastName': 'Brito-Sousa', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Fabio Trindade Maranhão', 'Initials': 'FTM', 'LastName': 'Costa', 'Affiliation': 'Universidade Estadual de Campinas.'}, {'ForeName': 'Maurício Lacerda', 'Initials': 'ML', 'LastName': 'Nogueira', 'Affiliation': 'Faculdade de Medicina de São José do Rio Preto.'}, {'ForeName': 'Djane', 'Initials': 'D', 'LastName': 'Baía-da-Silva', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Mariana Simão', 'Initials': 'MS', 'LastName': 'Xavier', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Wuelton Marcelo', 'Initials': 'WM', 'LastName': 'Monteiro', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Marcus Vinícius Guimarães', 'Initials': 'MVG', 'LastName': 'Lacerda', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1177']
2318,32785727,Comparison of Toric Intraocular Lens Alignment Between Femtosecond Laser-Assisted Capsular Marking and Manual Corneal Marking.,"PURPOSE


To compare toric intraocular lens (IOL) alignment between femtosecond laser-assisted capsular marking and manual corneal marking.
METHODS


This study prospectively included 72 consecutive eyes (from 72 patients) with cataract and anterior corneal astigmatism of 1.00 diopter (D) or greater that underwent femtosecond laser-assisted cataract surgery with implantation of a toric IOL. These eyes were randomly categorized into two groups based on the IOL alignment method. The femtosecond laser capsular marking group included 36 eyes with capsular markers using the latest femtosecond laser platform. The manual marking group included 36 eyes with manual corneal markers. The preservation of the markers was assessed. Visual acuity and refractive outcomes, as well as deviation from the target axis, were evaluated.
RESULTS


In the femtosecond laser capsular marking group, all capsular markers were retained for at least 3 months. In the manual marking group, 22.2% of the corneal markers disappeared within 1 month and all markers disappeared within 3 months. At 1 month postoperatively, the mean magnitudes of refractive astigmatism were -0.41 ± 0.26 and -0.45 ± 0.31 D (P = .81), and the uncorrected distance visual acuities were 0.07 ± 0.06 and 0.07 ± 0.05 logMAR (P = .56) in the femtosecond laser capsular marking and manual marking groups, respectively. The misalignment of the toric IOL within 1 hour postoperatively was 1.5° ± 1.4° in the femtosecond laser capsular marking group and 4.4° ± 2.1° in the manual marking group (P < .01). The deviation from the target axis of implantation was 1.6° ± 1.3° in the femtosecond laser capsular group and 4.8° ± 2.5° in the manual marking group (P < .01) at 1 month postoperatively.
CONCLUSIONS


IOL misalignment was significantly lower in the femtosecond laser-assisted capsular marking group than in the manual corneal marking group. In addition, the long-term preservation of the capsular marker is helpful in evaluating the rotation of the toric IOL. [J Refract Surg. 2020;36(8):536-542.].",2020,"CONCLUSIONS


IOL misalignment was significantly lower in the femtosecond laser-assisted capsular marking group than in the manual corneal marking group.","['36 eyes with manual corneal markers', '72 consecutive eyes (from 72 patients) with cataract and anterior corneal astigmatism of 1.00 diopter (D) or greater that underwent']","['toric intraocular lens (IOL) alignment between femtosecond laser-assisted capsular marking and manual corneal marking', 'Toric Intraocular Lens Alignment Between Femtosecond Laser-Assisted Capsular Marking and Manual Corneal Marking', 'femtosecond laser capsular marking', 'femtosecond laser capsular marking group included 36 eyes with capsular markers using the latest femtosecond laser platform', 'femtosecond laser-assisted capsular marking', 'femtosecond laser-assisted cataract surgery with implantation of a toric IOL']","['mean magnitudes of refractive astigmatism', 'uncorrected distance visual acuities', 'Visual acuity and refractive outcomes']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C3880124', 'cui_str': 'Corneal marker'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0339682', 'cui_str': 'Regular astigmatism - corneal'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}, {'cui': 'C0205393', 'cui_str': 'Most'}]","[{'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",36.0,0.0189193,"CONCLUSIONS


IOL misalignment was significantly lower in the femtosecond laser-assisted capsular marking group than in the manual corneal marking group.","[{'ForeName': 'Danmin', 'Initials': 'D', 'LastName': 'Cao', 'Affiliation': ''}, {'ForeName': 'Yanxue', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}]","Journal of refractive surgery (Thorofare, N.J. : 1995)",['10.3928/1081597X-20200602-01']
2319,32785749,The extended pessary interval for care (EPIC) study: a failed randomized clinical trial.,"INTRODUCTION AND HYPOTHESIS


To describe study design flaws and limited outcomes of a randomized trial that intended to compare satisfaction and complication rates between patients managing their pelvic organ prolapse with a pessary at different maintenance intervals.
METHODS


A randomized clinical trial was conducted at two tertiary pessary clinics. After a successful fitting, patients were randomly allocated to follow-up at 3-month or 6-month intervals and followed for 12 months. Symptoms, complications, and pelvic examination characteristics were recorded at each visit. At 6 and 12 months, patient satisfaction with the pessary was also recorded. Sample size calculation was based on the minimal relevant difference in Pessary Satisfaction score (created for this study). With a power of 0.8 and an alpha of 0.05, the minimum number of patients required in each group was 28.
RESULTS


We were unable to reach our sample size as most patients did not meet inclusion criteria. After 2 years we were only able to recruit 20/56 patients, with 9 patients in the 3-month group and 11 patients in the 6-month group. Additionally, seven patients dropped out of the study. Overall satisfaction was high and similar between groups at 6- and 12-month follow-up visits. Pessary complications were noted in both groups but in low numbers.
CONCLUSIONS


Pessary use is associated with high patient satisfaction and low complication rates, regardless of the follow-up interval. The recruitment failure demonstrated that a randomized trial is not feasible for this research question. Optimally, pessary follow-up should be based on patient symptoms and scheduling preference.",2020,Overall satisfaction was high and similar between groups at 6- and 12-month follow-up visits.,"['two tertiary pessary clinics', 'patients managing their pelvic organ prolapse with a pessary at different maintenance intervals']",[],"['Overall satisfaction', 'satisfaction and complication rates', 'Pessary complications', 'Symptoms, complications, and pelvic examination characteristics', 'Pessary Satisfaction score']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0200045', 'cui_str': 'Manual pelvic examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.184407,Overall satisfaction was high and similar between groups at 6- and 12-month follow-up visits.,"[{'ForeName': 'Breffini', 'Initials': 'B', 'LastName': 'Anglim', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynaecology, Mount Sinai Hospital, University of Toronto, 8-815, 700 University Ave., Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Zi Ying', 'Initials': 'ZY', 'LastName': 'Zhao', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Lovatsis', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynaecology, Mount Sinai Hospital, University of Toronto, 8-815, 700 University Ave., Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Colleen D', 'Initials': 'CD', 'LastName': 'McDermott', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynaecology, Mount Sinai Hospital, University of Toronto, 8-815, 700 University Ave., Mount Sinai Hospital, Toronto, Ontario, Canada. colleen.mcdermott@utoronto.ca.'}]",International urogynecology journal,['10.1007/s00192-020-04489-w']
2320,32785881,Calcipotriol/Betamethasone Dipropionate Cutaneous Foam Treatment for Psoriasis in Patients With BSA 5-15% and PGA ≥ 3: Post-Hoc Analysis From Three Randomized Controlled Trials.,"INTRODUCTION


Psoriasis is a chronic, inflammatory disease, which ranges in severity from mild to severe. Although topical therapies are frequently used to treat mild disease, they are not routinely used to treat patients with moderate-to-severe disease who have a larger proportion of their body surface area (BSA) affected (≥ 5% BSA). Based on well-controlled trials in adults with mild-to-severe disease, fixed-dose combination calcipotriol 50 μg/g + betamethasone dipropionate 0.5 mg/g (Cal/BD) cutaneous foam has been approved (Enstilar®, LEO Pharma) in the USA and EU for the treatment of psoriasis vulgaris for up to 4 weeks in adults. In this post-hoc subgroup analysis, we used pooled data from phase II/III trials to investigate the efficacy and safety of Cal/BD cutaneous foam in patients with moderate-to-severe psoriasis.
METHODS


Patients included in this analysis had psoriasis affecting 5-15% BSA and a physician's global assessment (PGA) ≥ 3. Endpoints included: treatment success by PGA (rating: clear/almost clear), patient's global assessment (PaGA) at week 4 (rating: clear/very mild) and safety.
RESULTS


A total of 340 patients in the three randomized trials met the BSA/PGA inclusion criteria, of whom 254 were treated with Cal/BD foam and 86 with vehicle foam. Treatment success by PGA and PaGA at week 4 was achieved in 143 (58.1%) and 138 (56.1%) patients receiving Cal/BD foam, respectively, versus three (3.6%) and 14 (16.7%) patients receiving vehicle foam. Sixty-six adverse events (AEs) occurred in 47 (18.5%) patients receiving Cal/BD foam and 11 AEs occurred in 11 (12.8%) patients receiving vehicle foam. Three severe AEs and 15 non-serious treatment-related AEs occurred in patients receiving Cal/BD foam.
CONCLUSION


The results from three clinical trials analyzed together show that topical Cal/BD foam is well tolerated and efficacious for treating patients with moderate-to-severe disease. Data support Cal/BD foam as a potential topical therapy for moderate-to-severe psoriasis.
TRIAL REGISTRATIONS


ClinicalTrials.gov registration numbers: NCT01866163, NCT02132936, NCT01536886.",2020,"Treatment success by PGA and PaGA at week 4 was achieved in 143 (58.1%) and 138 (56.1%) patients receiving Cal/BD foam, respectively, versus three (3.6%) and 14 (16.7%) patients receiving vehicle foam.","[""Patients included in this analysis had psoriasis affecting 5-15% BSA and a physician's global assessment (PGA)\u2009≥\u20093"", '340 patients in the three randomized trials met the BSA/PGA inclusion criteria, of whom 254 were treated with Cal/BD foam and 86 with vehicle foam', 'adults with mild-to-severe disease, fixed-dose combination calcipotriol 50 μg', 'patients with moderate-to-severe psoriasis', 'Psoriasis in Patients With BSA 5-15% and PGA\u2009≥\u20093', 'patients with moderate-to-severe disease', 'patients with moderate-to-severe disease who have a larger proportion of their body surface area (BSA) affected (≥\u20095% BSA']","['g + betamethasone dipropionate 0.5', 'Calcipotriol/Betamethasone Dipropionate Cutaneous Foam']","[""treatment success by PGA (rating: clear/almost clear), patient's global assessment (PaGA) at week 4 (rating: clear/very mild) and safety"", 'tolerated and efficacious']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0065767', 'cui_str': 'calcipotriene'}, {'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3653162', 'cui_str': 'calcipotriol, combinations'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0549177', 'cui_str': 'Large'}]","[{'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0065767', 'cui_str': 'calcipotriene'}, {'cui': 'C1160727', 'cui_str': 'Cutaneous foam'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",340.0,0.163511,"Treatment success by PGA and PaGA at week 4 was achieved in 143 (58.1%) and 138 (56.1%) patients receiving Cal/BD foam, respectively, versus three (3.6%) and 14 (16.7%) patients receiving vehicle foam.","[{'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Iversen', 'Affiliation': 'Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark. lars.iversen@clin.au.dk.'}, {'ForeName': 'Merle', 'Initials': 'M', 'LastName': 'Kurvits', 'Affiliation': 'Biostatistics Department, LEO Pharma, Ballerup, Denmark.'}, {'ForeName': 'Anja Marieke', 'Initials': 'AM', 'LastName': 'Snel-Prentø', 'Affiliation': 'Global Medical Affairs, LEO Pharma, Ballerup, Denmark.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Menter', 'Affiliation': 'Division of Dermatology, Baylor Scott & White Health, Dallas, TX, USA.'}]",Dermatology and therapy,['10.1007/s13555-020-00419-2']
2321,32785897,Impact of short-term hydrocortisone intake on pituitary and adrenal function in healthy young male subjects.,"PURPOSE


The aim of this study was to evaluate the impact of short-term therapeutic hydrocortisone intake on pituitary and adrenal function in healthy young male subjects.
METHODS


Ten physically active men received 50 mg/per day of hydrocortisone at 8:00 a.m. for 5 days. Cortisol, DHEA, and ACTH concentrations in plasma, and cortisol and DHEA concentrations in saliva were determined the week before, just before (8:00 a.m.) and 2 h after (10:00 a.m.) drug ingestion on days 1, 3, and 5 of treatment and day 1 post treatment.
RESULTS


Hydrocortisone intake induced a significant increase in both plasma cortisol (×3) and saliva cortisol (×10) concentrations 2 h after administration. Plasma and saliva DHEA concentrations were significantly decreased, as were plasma ACTH concentrations, 2 h after administration, with an increase in the cortisol/DHEA and cortisol/ACTH ratios. However, no change in cortisol, DHEA, ACTH, cortisol/DHEA, or cortisol/ACTH was observed 24 h after the last intake during treatment or post treatment, except for a downward trend in saliva DHEA at days 3 and 5. The correlations between plasma and saliva cortisol, DHEA, and cortisol/DHEA were significant: respectively, r = 0.80, r = 0.80, and r = 0.88.
CONCLUSIONS


Once-daily oral therapeutic administration of hydrocortisone for 5 days altered adrenal DHEA secretion by inhibiting pituitary ACTH, but this effect seemed transient without significant impairment of basal adrenal or pituitary function 24 h after administration. Given the high correlations between plasma and saliva, saliva samples may be offered as a sensitive surrogate for blood sampling to estimate adrenal and pituitary function.",2020,"However, no change in cortisol, DHEA, ACTH, cortisol/DHEA, or cortisol/ACTH was observed 24 h after the last intake during treatment or post treatment, except for a downward trend in saliva DHEA at days 3 and 5.","['healthy young male subjects', 'Ten physically active men']","['hydrocortisone', 'short-term hydrocortisone intake', 'short-term therapeutic hydrocortisone intake']","['Cortisol, DHEA, and ACTH concentrations in plasma, and cortisol and DHEA concentrations in saliva', 'pituitary and adrenal function', 'cortisol, DHEA, ACTH, cortisol/DHEA, or cortisol/ACTH', 'adrenal DHEA secretion', 'plasma ACTH concentrations', 'Plasma and saliva DHEA concentrations', 'cortisol/DHEA and cortisol/ACTH ratios', 'plasma and saliva cortisol, DHEA, and cortisol/DHEA', 'plasma cortisol (×3) and saliva cortisol (×10) concentrations 2\u2009h']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1281899', 'cui_str': 'Plasma cortisol measurement'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}]",10.0,0.0710515,"However, no change in cortisol, DHEA, ACTH, cortisol/DHEA, or cortisol/ACTH was observed 24 h after the last intake during treatment or post treatment, except for a downward trend in saliva DHEA at days 3 and 5.","[{'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Collomp', 'Affiliation': ""CIAMS, Université d'Orléans, Orléans, France. katia.collomp@univ-orleans.fr.""}, {'ForeName': 'Virgile', 'Initials': 'V', 'LastName': 'Amiot', 'Affiliation': 'Service de Médecine du Sport, CHR Orléans, Orléans, France.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Robin', 'Affiliation': 'Département des Analyses, AFLD, Chatenay-Malabry, France.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Ericsson', 'Affiliation': 'Département des Analyses, AFLD, Chatenay-Malabry, France.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Buisson', 'Affiliation': 'Département des Analyses, AFLD, Chatenay-Malabry, France.'}]",Endocrine,['10.1007/s12020-020-02450-x']
2322,32785971,Levofloxacin prophylaxis in hospitalized children with leukemia: A cost-utility analysis.,"BACKGROUND


Infections are common and are a major cause of morbidity and mortality during treatment of childhood leukemia. We evaluated the cost effectiveness of levofloxacin antibiotic prophylaxis, compared to no prophylaxis, in children receiving chemotherapy for acute myeloid leukemia (AML) or relapsed acute lymphoblastic leukemia (ALL).
PROCEDURES


A cost-utility analysis was conducted from the perspective of the single-payer health care system using a lifetime horizon. A comprehensive literature review identified available evidence for effectiveness, safety, costs of antibiotic prophylaxis in children with leukemia, and health utilities associated with the relevant health states. The effects of levofloxacin prophylaxis on health outcomes, quality-adjusted life-years (QALY), and direct health costs were derived from a combined decision tree and state-transition model. One-way deterministic and probabilistic sensitivity analyses were performed to test the sensitivity of results to parameter uncertainty.
RESULTS


The literature review revealed one randomized controlled trial on levofloxacin prophylaxis in childhood AML and relapsed ALL, by Alexander et al, that showed a significant reduction in rates of fever and neutropenia (71.2% vs 82.1%) and bacteremia (21.9% vs 43.4%) with levofloxacin compared to no prophylaxis. In our cost-utility analysis, levofloxacin prophylaxis was dominant over no prophylaxis, resulting in cost savings of $542.44 and increased survival of 0.13 QALY. In probabilistic sensitivity analysis, levofloxacin prophylaxis was dominant in 98.8% of iterations.
CONCLUSIONS


The present analysis suggests that levofloxacin prophylaxis, compared to no prophylaxis, is cost saving in children receiving intensive chemotherapy for AML or relapsed ALL.",2020,"al, that showed a significant reduction in rates of fever and neutropenia (71.2% vs 82.1%) and bacteremia (21.9% vs 43.4%) with levofloxacin compared to no prophylaxis.","['children receiving chemotherapy for acute myeloid leukemia (AML) or relapsed acute lymphoblastic leukemia (ALL', 'hospitalized children with leukemia', 'children with leukemia, and health utilities associated with the relevant health states', 'childhood leukemia', 'childhood AML and relapsed ALL, by Alexander et', 'children receiving intensive chemotherapy for AML or relapsed ALL']","['antibiotic prophylaxis', 'levofloxacin antibiotic prophylaxis', 'levofloxacin', 'Levofloxacin prophylaxis', 'levofloxacin prophylaxis']","['rates of fever and neutropenia', 'cost savings', 'health outcomes, quality-adjusted life-years (QALY), and direct health costs', 'bacteremia']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}]","[{'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}]",,0.0338525,"al, that showed a significant reduction in rates of fever and neutropenia (71.2% vs 82.1%) and bacteremia (21.9% vs 43.4%) with levofloxacin compared to no prophylaxis.","[{'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Maser', 'Affiliation': 'The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Pelland-Marcotte', 'Affiliation': 'The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Alexander', 'Affiliation': 'The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Sung', 'Affiliation': 'The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'The Hospital for Sick Children, Toronto, Ontario, Canada.'}]",Pediatric blood & cancer,['10.1002/pbc.28643']
2323,32785972,Nitric oxide is fundamental to neurovascular coupling in humans.,"KEY POINTS


Pre-clinical models have demonstrated that nitric oxide is a key component of neurovascular coupling; this has yet to be translated to humans We conducted two separate protocols utilizing intravenous infusion of a nitric oxide synthase inhibitor and isovolumic hemodilution to assess the influence of nitric oxide in humans Isovolumic hemodilution did not alter neurovascular coupling Intravenous infusion of a nitric oxide synthase inhibitor reduced the neurovascular coupling response by ∼30% indicating that nitric oxide is integral to neurovascular coupling in humans ABSTRACT: Nitric oxide is a vital neurovascular signalling molecule in pre-clinical models, yet the mechanisms underlying neurovascular coupling (NVC) in humans have yet to be elucidated. To investigate the contribution of nitric oxide to NVC in humans we utilized a visual stimulus paradigm to elicit a NVC response in the posterior cerebral circulation. Two distinct mechanistic interventions were conducted on young healthy males: 1) NVC was assessed during intravenous infusion of saline (placebo) and the non-selective competitive nitric oxide synthase inhibitor N G  -monomethyl- L  -arginine (L-NMMA, 5 mg kg -1  bolus & subsequent 50 μg kg -1   min -1 m  aintenance dose; n = 10). The order of infusion was randomized, counter balanced, and single blinded. A subset of participants in this study (n = 4) underwent a separate intervention with phenylephrine infusion to independently consider the influence of blood pressure changes on NVC (0.1-0.6 μg Kg -1   min -1  constant infusion). 2) NVC was assessed prior to and following isovolumic hemodilution, whereby 20% of whole blood was removed and replaced with 5% human serum albumin to reduce hemoglobin concentration (n = 8). For both protocols, arterial and internal jugular venous blood samples were collected at rest and coupled with volumetric measures of cerebral blood flow (duplex ultrasound) to quantify resting cerebral metabolic parameters. L-NMMA elicited a 30% reduction in the peak (P = 0.01), but not average (P = 0.11), NVC response. Neither phenylephrine nor hemodilution influenced NVC. Nitric oxide signalling is integral to NVC in humans, providing a new direction for research into pharmacological treatment of humans with dementia. This article is protected by copyright. All rights reserved.",2020,"L-NMMA elicited a 30% reduction in the peak (P = 0.01), but not average (P = 0.11), NVC response.","['humans with dementia', 'young healthy males']","['bolus & subsequent 50\xa0μg\xa0kg -1', 'arginine', 'phenylephrine', 'saline (placebo) and the non-selective competitive nitric oxide synthase inhibitor N G  -monomethyl', 'phenylephrine infusion', 'L']","['NVC response', 'cerebral blood flow (duplex ultrasound', 'blood pressure changes on NVC']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0132555', 'cui_str': 'Nitric-oxide synthase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0242845', 'cui_str': 'Duplex ultrasound'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}]",,0.0290705,"L-NMMA elicited a 30% reduction in the peak (P = 0.01), but not average (P = 0.11), NVC response.","[{'ForeName': 'Ryan L', 'Initials': 'RL', 'LastName': 'Hoiland', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC, V1V 1V7, Canada.'}, {'ForeName': 'Hannah G', 'Initials': 'HG', 'LastName': 'Caldwell', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC, V1V 1V7, Canada.'}, {'ForeName': 'Connor A', 'Initials': 'CA', 'LastName': 'Howe', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC, V1V 1V7, Canada.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Nowak-Flück', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC, V1V 1V7, Canada.'}, {'ForeName': 'Benjamin S', 'Initials': 'BS', 'LastName': 'Stacey', 'Affiliation': 'Neurovascular Research Laboratory, Faculty of Life Sciences and Education, University of South Wales, Pontypridd, CF37 4BB, UK.'}, {'ForeName': 'Damian M', 'Initials': 'DM', 'LastName': 'Bailey', 'Affiliation': 'Neurovascular Research Laboratory, Faculty of Life Sciences and Education, University of South Wales, Pontypridd, CF37 4BB, UK.'}, {'ForeName': 'Julian F R', 'Initials': 'JFR', 'LastName': 'Paton', 'Affiliation': 'Department of Physiology, Faculty of Medical & Health Sciences, University of Auckland, Park Road, Grafton, Auckland, 1142, New Zealand.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'School of Human Sciences (Exercise and Sport Sciences), The University of Western Australia, Nedlands, Western Australia, 6009.'}, {'ForeName': 'Mypinder S', 'Initials': 'MS', 'LastName': 'Sekhon', 'Affiliation': 'Division of Critical Care Medicine, Department of Medicine, Vancouver General Hospital, West 12th Avenue, University of British Columbia, Vancouver, BC, V5Z 1M9, Canada.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Macleod', 'Affiliation': 'Human Pharmacology & Physiology Lab, Department of Anesthesiology, Duke University Medical Center, Durham, NC, 27708, USA.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Ainslie', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC, V1V 1V7, Canada.'}]",The Journal of physiology,['10.1113/JP280162']
2324,32785986,The efficacy of microneedling alone vs its combination with 5- Fluorouracil Solution vs 5-Fluorouracil intralesional injection in the Treatment of Plantar Warts.,"Intralesional 5- fluorouracil (IL5-FU) has been used off-label for warts treatment; however its use was limited by intense pain. Combination treatment can offer a robust therapeutic effect. Was to assess the therapeutic efficacy, safety and tolerability of microneedling vs its combination with 5-FU solution vs IL5-FU in the treatment of plantar warts.
PATIENTS AND METHODS


Ninety Patients with plantar warts were divided randomly into three groups each containing 30 patients. Group A received (intralesional 5-FU), group B (microneedling) while group C (microneedling and 5-FU solution). All groups received treatment for a maximum of six sessions 2 weeks apart.
RESULTS


Complete response was observed in 86.7% of the warts treated with 5-FU and microneedling (group C) vs to76.7% and70% in group A and B respectively with no statistically significant difference (P = 0.36). A significant increase in the number of sessions (P = 0.01) and pain score (P = 0.001) were found among group A compared to groups B and C. Patient's satisfaction was higher in group C (P = 0.05).No recurrence was reported in all groups.
CONCLUSION


Microneedling can be used as alternative or adjuvant therapeutic modality for plantar warts treatment and significantly associated with less pain. Combination group was superior compared to the others. This article is protected by copyright. All rights reserved.",2020,"A significant increase in the number of sessions (P = 0.01) and pain score (P = 0.001) were found among group A compared to groups B and C. Patient's satisfaction was higher in group C (P = 0.05).No recurrence was reported in all groups.
","['Plantar Warts', 'plantar warts', 'Ninety Patients with plantar warts']","['5-FU solution vs IL5-FU', 'microneedling alone vs its combination with 5- Fluorouracil Solution vs 5-Fluorouracil intralesional injection', '5-FU', 'intralesional 5-FU), group B (microneedling) while group C (microneedling and 5-FU solution', 'Intralesional 5- fluorouracil (IL5-FU']","['number of sessions', 'pain score', 'therapeutic efficacy, safety and tolerability', 'pain']","[{'cui': 'C0042548', 'cui_str': 'Verruca plantaris'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021490', 'cui_str': 'Intralesional injection'}, {'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0441837', 'cui_str': 'Group C'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",90.0,0.0172998,"A significant increase in the number of sessions (P = 0.01) and pain score (P = 0.001) were found among group A compared to groups B and C. Patient's satisfaction was higher in group C (P = 0.05).No recurrence was reported in all groups.
","[{'ForeName': 'Soheir', 'Initials': 'S', 'LastName': 'Ghonemy', 'Affiliation': 'Dermatology Department, Faculty of Medicine, Zagazig University, Egypt, Zagazig.'}, {'ForeName': 'Mahitab', 'Initials': 'M', 'LastName': 'Ibrahim Ali', 'Affiliation': 'Dermatology Department, Faculty of Medicine, Zagazig University, Egypt, Zagazig.'}, {'ForeName': 'Howyda Mohamed', 'Initials': 'HM', 'LastName': 'Ebrahim', 'Affiliation': 'Dermatology Department, Faculty of Medicine, Zagazig University, Egypt, Zagazig.'}]",Dermatologic therapy,['10.1111/dth.14179']
2325,32787932,Culturally and developmentally adapting group interpersonal therapy for adolescents with depression in rural Nepal.,"BACKGROUND


Evidence-based interventions are needed to reduce depression among adolescents in low- and middle-income countries (LMICs). One approach could be cultural adaptation of psychological therapies developed in high-income countries. We aimed to adapt the World Health Organization's Group Interpersonal Therapy (IPT) Manual for adolescents with depression in rural Nepal.
METHODS


We used a participatory, multi-stage adaptation process involving: translation and clinical review of the WHO Manual; desk reviews of adaptations of IPT in LMICs, and literature on child and adolescent mental health interventions and interpersonal problems in Nepal; a qualitative study to understand experiences of adolescent depression and preferences for a community-based psychological intervention including 25 interviews with adolescent boys and girls aged 13-18 with depression, four focus group discussions with adolescents, four with parents/caregivers and two with teachers, six interviews with community health workers and one with a representative from a local non-governmental organisation (total of 126 participants); training of IPT trainers and facilitators and practice IPT groups; and consultation with a youth mental health advisory board. We used the Ecological Validity Framework to guide the adaptation process.
RESULTS


We made adaptations to optimise treatment delivery and emphasise developmental and cultural aspects of depression. Key adaptations were: integrating therapy into secondary schools for delivery by school nurses and lay community members; adding components to promote parental engagement including a pre-group session with the adolescent and parent to mobilise parental support; using locally acceptable terms for mental illness such as udas-chinta (sadness and worry) and man ko samasya (heart-mind problem); framing the intervention as a training programme to de-stigmatise treatment; and including activities to strengthen relationships between group members. We did not adapt the therapeutic goals of IPT and conserved IPT-specific strategies and techniques, making edits only to the way these were described in the Manual.
CONCLUSIONS


Group IPT can be adapted for adolescents in Nepal and delivered through the education system. A randomised controlled trial is needed to assess the impact and costs of the intervention in this setting. Future research in LMICs to adapt IPT for adolescents could use this adapted intervention as a starting point.",2020,"We aimed to adapt the World Health Organization's Group Interpersonal Therapy (IPT) Manual for adolescents with depression in rural Nepal.
","['adolescents in low- and middle-income countries (LMICs', '25 interviews with adolescent boys and girls aged 13-18 with depression, four focus group discussions with adolescents, four with parents/caregivers and two with teachers, six interviews with community health workers and one with a representative from a local non-governmental organisation (total of 126 participants', 'adolescents with depression in rural Nepal']","['training of IPT trainers and facilitators and practice IPT groups; and consultation with a youth mental health advisory board', 'integrating therapy into secondary schools for delivery by school nurses and lay community members; adding components to promote parental engagement including a pre-group session with the adolescent and parent to mobilise parental support; using locally acceptable terms for mental illness such as udas-chinta (sadness and worry) and man ko samasya (heart-mind problem); framing the intervention as a training programme to de-stigmatise treatment', ""World Health Organization's Group Interpersonal Therapy (IPT) Manual"", 'Culturally and developmentally adapting group interpersonal therapy', 'community-based psychological intervention']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0302833', 'cui_str': 'School nurse'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0418946', 'cui_str': 'Parental support'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]",[],126.0,0.0626019,"We aimed to adapt the World Health Organization's Group Interpersonal Therapy (IPT) Manual for adolescents with depression in rural Nepal.
","[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Rose-Clarke', 'Affiliation': ""Department of Global Health and Social Medicine, King's College London, London, WC2B 4BG, UK. kelly.rose-clarke@kcl.ac.uk.""}, {'ForeName': 'Indira', 'Initials': 'I', 'LastName': 'Pradhan', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Kathmandu, Nepal.'}, {'ForeName': 'Pragya', 'Initials': 'P', 'LastName': 'Shrestha', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Kathmandu, Nepal.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'B K', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Kathmandu, Nepal.'}, {'ForeName': 'Jananee', 'Initials': 'J', 'LastName': 'Magar', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Kathmandu, Nepal.'}, {'ForeName': 'Nagendra P', 'Initials': 'NP', 'LastName': 'Luitel', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Kathmandu, Nepal.'}, {'ForeName': 'Delan', 'Initials': 'D', 'LastName': 'Devakumar', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Alexandra Klein', 'Initials': 'AK', 'LastName': 'Rafaeli', 'Affiliation': 'Psychological Services, Ruth and Allen Ziegler Student Services Division, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Clougherty', 'Affiliation': 'Global Mental Health Lab, Teachers College, Columbia University, New York, NY, USA.'}, {'ForeName': 'Brandon A', 'Initials': 'BA', 'LastName': 'Kohrt', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, and Department of Global Health, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Mark J D', 'Initials': 'MJD', 'LastName': 'Jordans', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Kathmandu, Nepal.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Verdeli', 'Affiliation': 'Global Mental Health Lab, Teachers College, Columbia University, New York, NY, USA.'}]",BMC psychology,['10.1186/s40359-020-00452-y']
2326,32787944,Resident-to-resident elder mistreatment (R-REM) intervention for direct care staff in assisted living residences: study protocol for a cluster randomized controlled trial.,"BACKGROUND


Resident-to-resident elder mistreatment (R-REM) is defined as negative and aggressive physical, sexual, or verbal interactions between (long-term care) residents that in a community setting would likely be construed as unwelcome and have high potential to cause physical and/or psychological harm and distress. R-REM has been established as a serious problem that has a negative impact on the safety, physical well-being, and quality-of-life of residents living in nursing homes. Although there are no in-depth studies, there is evidence that it is prevalent in assisted living residences and associated with a variety of person, environmental, and facility characteristics. The authors conducted the first systematic, prospective study of resident-to-resident elder mistreatment in nursing homes and developed an intervention for direct care staff to enhance knowledge of R-REM and increase reporting and resident safety by reducing falls and associated injuries. The study aim was to examine the effects of this intervention in assisted living residences. The primary distal outcome is falls and injuries, and the key process outcomes are staff knowledge and reporting.
METHODS


Twelve larger licensed assisted living residences with special care dementia units in two New York State regions will be enrolled on a rolling basis and randomized to intervention or usual care. Data derived from five sources, (1) resident interviews, (2) staff informants, (3) observational data, (4) chart, and (5) incident/accident report data, will be collected at baseline and 6 and 12 months with respect to 1050 residents (750 ""downstate"" and 300 ""upstate""). The intervention is three training modules delivered on-site after baseline data collection for front line staff on all shifts in facilities randomized to the intervention. Modules relate to recognition, management, and reporting of resident-to-resident elder mistreatment.
DISCUSSION


Given the movement toward alternative congregate living arrangements for older individuals with significant comorbidities, including cognitive impairment; it is critical to enhance resident safety measured by falls, accidents, and injuries and staff knowledge related to recognition, reporting, and treatment of resident-to-resident aggressive and related negative interactions in such settings. This project is important in developing approaches for ameliorating and preventing R-REM in assisted living residences and enhancing resident safety and quality of life.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03383289 . Registered on 26 December 2017.",2020,The intervention is three training modules delivered on-site after baseline data collection for front line staff on all shifts in facilities randomized to the intervention.,"['assisted living residences', 'Twelve larger licensed assisted living residences with special care dementia units in two New York State regions will be enrolled on a rolling basis and randomized to intervention or usual care', 'older individuals with significant comorbidities, including cognitive impairment']",['Resident-to-resident elder mistreatment (R-REM) intervention'],"['falls and injuries, and the key process outcomes are staff knowledge and reporting']","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0623181,The intervention is three training modules delivered on-site after baseline data collection for front line staff on all shifts in facilities randomized to the intervention.,"[{'ForeName': 'Jeanne A', 'Initials': 'JA', 'LastName': 'Teresi', 'Affiliation': 'Research Division, Hebrew Home at Riverdale, Bronx, NY, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Silver', 'Affiliation': 'Research Division, Hebrew Home at Riverdale, Bronx, NY, USA. sasilver98@aol.com.'}, {'ForeName': 'Mildred', 'Initials': 'M', 'LastName': 'Ramirez', 'Affiliation': 'Research Division, Hebrew Home at Riverdale, Bronx, NY, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': 'Research Division, Hebrew Home at Riverdale, Bronx, NY, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Eimicke', 'Affiliation': 'Research Division, Hebrew Home at Riverdale, Bronx, NY, USA.'}, {'ForeName': 'Gabriel D', 'Initials': 'GD', 'LastName': 'Boratgis', 'Affiliation': 'Research Division, Hebrew Home at Riverdale, Bronx, NY, USA.'}, {'ForeName': 'Rhoda', 'Initials': 'R', 'LastName': 'Meador', 'Affiliation': 'Bronfenbrenner Center for Translational Research, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Schultz', 'Affiliation': 'College of Human Ecology, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Lachs', 'Affiliation': 'Division of Geriatrics and Palliative Medicine, The Weill Medical College of Cornell University, New York, NY, USA.'}, {'ForeName': 'Karl A', 'Initials': 'KA', 'LastName': 'Pillemer', 'Affiliation': 'Division of Geriatrics and Palliative Medicine, The Weill Medical College of Cornell University, New York, NY, USA.'}]",Trials,['10.1186/s13063-020-04580-z']
2327,32788142,"Development and usability of PediAppRREST, a novel interactive tablet App to support the management of pediatric cardiac arrest: a pilot high-fidelity simulation-based study.","BACKGROUND


Pediatric cardiac arrest (PCA) although rare is associated with high mortality. Deviations from international management guidelines are frequent and associated with poorer outcomes. Different strategies/devices have been developed to improve the management of cardiac arrest, including cognitive aids. However, there is very limited experience on the usefulness of interactive cognitive aids in the format of an application (App) in PCA. No App has so far been tested for its usability and effectiveness in guiding the management of PCA.
OBJECTIVE


To develop a new audiovisual interactive App for tablets, named PediAppRREST, to support the management of PCA and to test its usability in a high-fidelity simulation-based setting.
METHODS


A research team at the University of Padova (Italy), and human-machine interface designers, as well as App developers, from an Italian company (RE:Lab S.r.l.) developed the App between March and October 2019, by applying an iterative design approach (i.e. design-prototyping-evaluation iterative loops). In October-November 2019, a single-center non-randomized controlled simulation-based pilot study was conducted including 48 pediatric residents divided in teams of three. The same non-shockable PCA scenario was managed by 11 teams with and 5 without the App. The App user's experience and interaction patterns were documented through video recording of scenarios, debriefing sessions and questionnaires. App usability was evaluated with the User Experience Questionnaire (UEQ) (scores range from -3 to +3 for each scale) and open-ended questions, while participants' workload was measured using the NASA Raw-Task Load Index (NASA RTLX).
RESULTS


Users' difficulties in interacting with the App during the simulations were identified using a structured framework. The App usability, in terms of UEQ scores, was as follows: attractiveness 1.71 (standard deviation [SD]=1.43); perspicuity 1.75 (SD=0.88); efficiency 1.93 (SD=0.93); dependability 1.57 (SD=1.10); stimulation 1.60 (SD=1.33); novelty 2.21 (SD=0.74). Team leaders' perceived workload was comparable (P=.57) between the two groups, median NASA RTLX score was 67.5 (interquartile range [IQR]=65.0-81.7) for the control group and 66.7 (IQR=54.2-76.7) for the intervention group. A preliminary evaluation of the effectiveness of the App in reducing deviations from guidelines showed that median time to epinephrine was significantly longer in the group that used the App compared to the control group (254 s versus 165 s; P=.015).
CONCLUSIONS


The PediAppRREST App received a good usability evaluation and did not appear to increase team leaders' workload. Based on the feedback collected from the participants and the preliminary results of the evaluation of its effects on the management of the simulated scenario, the App has been further refined. The effectiveness of the new version of the App in reducing deviations from guidelines recommendations in the management of PCA and impact on time to critical actions will be evaluated in an upcoming multicenter simulation-based randomized controlled trial.
CLINICALTRIAL


",2020,"Team leaders' perceived workload was comparable (P=.57) between the two groups, median NASA RTLX score was 67.5 (interquartile range [IQR]=65.0-81.7) for the control group and 66.7 (IQR=54.2-76.7) for the intervention group.",['48 pediatric residents divided in teams of three'],[],"['median NASA RTLX score', 'NASA Raw-Task Load Index (NASA RTLX', 'median time to epinephrine', 'User Experience Questionnaire (UEQ']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242776', 'cui_str': 'National Aeronautics and Space Administration'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0671974,"Team leaders' perceived workload was comparable (P=.57) between the two groups, median NASA RTLX score was 67.5 (interquartile range [IQR]=65.0-81.7) for the control group and 66.7 (IQR=54.2-76.7) for the intervention group.","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Corazza', 'Affiliation': ""Division of Pediatric Emergency Medicine, Department of Women's and Children's Health, University of Padova, via Giustiniani 3, Padova, IT.""}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Snijders', 'Affiliation': ""Division of Pediatric Emergency Medicine, Department of Women's and Children's Health, University of Padova, via Giustiniani 3, Padova, IT.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Arpone', 'Affiliation': ""Division of Pediatric Emergency Medicine, Department of Women's and Children's Health, University of Padova, via Giustiniani 3, Padova, IT.""}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Stritoni', 'Affiliation': ""Pediatric Intensive Care Unit, Department of Women's and Children's Health, University of Padova, Padova, IT.""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Martinolli', 'Affiliation': ""Division of Pediatric Emergency Medicine, Department of Women's and Children's Health, University of Padova, via Giustiniani 3, Padova, IT.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Daverio', 'Affiliation': ""Pediatric Intensive Care Unit, Department of Women's and Children's Health, University of Padova, Padova, IT.""}, {'ForeName': 'Maria Giulia', 'Initials': 'MG', 'LastName': 'Losi', 'Affiliation': 'RE:Lab S.r.l., Reggio Emilia, IT.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Soldi', 'Affiliation': 'RE:Lab S.r.l., Reggio Emilia, IT.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Tesauri', 'Affiliation': 'RE:Lab S.r.l., Reggio Emilia, IT.'}, {'ForeName': 'Liviana', 'Initials': 'L', 'LastName': 'Da Dalt', 'Affiliation': ""Division of Pediatric Emergency Medicine, Department of Women's and Children's Health, University of Padova, via Giustiniani 3, Padova, IT.""}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Bressan', 'Affiliation': ""Division of Pediatric Emergency Medicine, Department of Women's and Children's Health, University of Padova, via Giustiniani 3, Padova, IT.""}]",JMIR mHealth and uHealth,['10.2196/19070']
2328,32788149,Technology-Based Stepped Care to Stem Transgender Adolescent Risk Transmission: Protocol for a Randomized Controlled Trial (TechStep).,"BACKGROUND


Transgender youth demonstrate significantly higher rates of engagement in sexual risk behaviors relative to their cisgender or gender-conforming counterparts, including high rates of condomless anal intercourse and engagement in sex work. In addition, transgender youth experience increased physical or sexual abuse, victimization, substance use, mental health disorders, incarceration, and homelessness. Owing to these syndemic health disparities, transgender youth are at substantially increased risk of HIV infection.
OBJECTIVE


This protocol aims to describe a randomized controlled trial (RCT), Adolescent Medicine Trials Network 160 TechStep (N=250), which assesses the differential immediate and sustained effects of each of 3 conditions (text messaging, WebApp, or information-only control) for reducing sexual risk behaviors and increasing pre-exposure prophylaxis (PrEP) uptake among high-risk, HIV-negative transgender youth and young adults (aged 15-24 years).
METHODS


Participants will be recruited through web-based (targeted social media sites and apps) and offline (print ads and flyers) advertisements, peer and clinic referrals, and street- and venue-based outreach, and by contacting potential participants who have requested contact for future studies. Participants will be randomized into 1 of the 3 conditions: (1) text messaging, (2) WebApp, or (3) information-only control for 6 months. Assessments will occur at baseline and at 3, 6, and 9 months. Participants who do not show improvements in sexual risk or PrEP uptake at the 3-month assessment will be rerandomized to receive weekly electronic coaching (eCoaching) sessions in addition to their assigned text messaging or WebApp intervention, or remain in the original text messaging or WebApp intervention using a 2:1 ratio. Participants originally assigned to the information-only condition are not eligible for rerandomization.
RESULTS


Funding for TechStep was awarded in June 2017. Phase 1 was approved by the Institutional Review Board (IRB) in April 2018. Recruitment began in November 2018 for phase 1, the formative phase. Initial phase 2 IRB approval came in June 2019. The data collection for phase 2, the RCT, is expected to be completed in April 2021. As of March 2020, 54 participants have been enrolled in TechStep. The final results are anticipated in May 2021.
CONCLUSIONS


By providing culturally responsive, technology-based interventions, TechStep aims to improve sexual health outcomes among HIV-negative transgender youth and young adults at high risk of HIV. TechStep will evaluate the efficacy of technology-based interventions for reducing HIV sexual risk behaviors and increasing PrEP initiation, adherence, and persistence. The suite of technology-based interventions developed in TechStep, and assessed for efficacy in a 3-condition RCT, represents an important advancement in intervention science toward developing tailored and scalable interventions for transgender youth and young adults.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04000724; http://clinicaltrials.gov/ct2/show/NCT04000724.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/18326.",2020,"TechStep will evaluate the efficacy of technology-based interventions for reducing HIV sexual risk behaviors and increasing PrEP initiation, adherence, and persistence.","['to Stem Transgender Adolescent Risk Transmission', 'transgender youth and young adults', 'Participants will be recruited through web-based (targeted social media sites and apps) and offline (print ads and flyers) advertisements, peer and clinic referrals, and street- and venue-based outreach, and by contacting potential participants who have requested contact for future studies', 'high-risk, HIV-negative transgender youth and young adults (aged 15-24 years', '54 participants have been enrolled in TechStep', 'HIV-negative transgender youth and young adults at high risk of HIV']","['Technology-Based Stepped Care', 'By providing culturally responsive, technology-based interventions', '3 conditions (text messaging, WebApp, or information-only control) for reducing sexual risk behaviors and increasing pre-exposure prophylaxis (PrEP) uptake', 'electronic coaching (eCoaching) sessions in addition to their assigned text messaging or WebApp intervention, or remain in the original text messaging or WebApp intervention', 'text messaging, (2) WebApp, or (3) information-only control for 6 months']","['physical or sexual abuse, victimization, substance use, mental health disorders, incarceration, and homelessness', 'HIV sexual risk behaviors', 'sexual risk or PrEP uptake', 'sexual health outcomes']","[{'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0442658', 'cui_str': 'Street'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0205255', 'cui_str': 'Imprisonment'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.123827,"TechStep will evaluate the efficacy of technology-based interventions for reducing HIV sexual risk behaviors and increasing PrEP initiation, adherence, and persistence.","[{'ForeName': 'Cathy J', 'Initials': 'CJ', 'LastName': 'Reback', 'Affiliation': 'Friends Research Institute, Inc, Los Angeles, CA, United States.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Rusow', 'Affiliation': 'Friends Research Institute, Inc, Los Angeles, CA, United States.'}, {'ForeName': 'Demetria', 'Initials': 'D', 'LastName': 'Cain', 'Affiliation': 'PRIDE Health Research Consortium, Hunter College, City University of New York, New York, NY, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Benkeser', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Arayasirikul', 'Affiliation': 'Department of Pediatrics, Division of Developmental Medicine, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hightow-Weidman', 'Affiliation': 'Institute for Global Health and Infectious Diseases, The University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Keith J', 'Initials': 'KJ', 'LastName': 'Horvath', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, CA, United States.'}]",JMIR research protocols,['10.2196/18326']
2329,32788150,"Smartphone-Enhanced Symptom Management In Psychosis: Open, Randomized Controlled Trial.","BACKGROUND


Improving recovery from acute symptoms and preventing relapse are two significant challenges in severe mental illness. We developed a personalized smartphone-based app to monitor symptoms in real time and validated its acceptance, reliability, and validity.
OBJECTIVE


To assess (i) acceptability of continuous monitoring to SMI patients and health professionals over 3 months; (ii) impact of active self-monitoring on positive psychotic symptoms assessed at 6 and 12 weeks; and (iii) the feasibility of detecting early warning signs of relapse.
METHODS


The active symptom monitoring smartphone app was built into an end-to-end system in two NHS Trusts to enable real-time symptom self-monitoring and detection by the clinical team of early signs of relapse in people with severe mental illness. We conducted an open randomized controlled trial of active symptom monitoring compared to usual management to assess: (i) acceptability and safety of continuous monitoring over 3 months; (ii) impact of active self-monitoring on positive psychotic symptoms assessed at 6 and 12 weeks; (iii) feasibility of detecting early warning signs of relapse communicated to the healthcare staff via an app streaming data to the electronic health record. Eligible participants with a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of schizophrenia and related disorders, and a history of relapse within the previous two years were enrolled from an early intervention team and a community mental health team.
RESULTS


Of 181 eligible patients, 81 (45%) consented and were randomized to either active symptom monitoring or management as usual. At 12 weeks, 90% (33/36) of those in the active monitoring group continued to use the system and exhibited an adherence rate (defined as responding to >33% of alerts) of 84% (30/36}. Active symptom monitoring was associated with no difference on the empowerment scale in comparison to the usual management group at 12 weeks. The pre-planned intent-to-treat analysis of the primary outcome, a positive score on the Positive and Negative Syndrome Scale (PANSS) scale, showed a significant reduction in the active symptom monitoring group over 12 weeks in the early intervention center. Alerts for personalized early warning signs of relapse were built into the workflows of both NHS Trusts, and 100% of health professional staff used the system in a new digital workflow. Qualitative analyses supported the acceptability of the system to participants and staff.
CONCLUSIONS


The active smartphone monitoring system is feasible and was accepted by users in a 3-month study of people with severe mental illness, with surprisingly high levels of adherence. App use was associated with psychotic symptom improvement in recent-onset participants, but not those with longstanding illness, supporting the notion of improved self-management. When built into clinical management workflows to enable personalized alerts of symptom deterioration, the app has demonstrated utility in promoting earlier intervention for relapse.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN88145142; http://www.isrctn.com/ISRCTN88145142.",2020,"At 12 weeks, 90% (33/36) of those in the active monitoring group continued to use the system and exhibited an adherence rate (defined as responding to >33% of alerts) of 84% (30/36}. Active symptom monitoring was associated with no difference on the empowerment scale in comparison to the usual management group at 12 weeks.","['people with severe mental illness', '181 eligible patients, 81 (45%) consented', 'Eligible participants with a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of schizophrenia and related disorders, and a history of relapse within the previous two years were enrolled from an early intervention team and a community mental health team']","['active self-monitoring', 'continuous monitoring over 3 months; (ii) impact of active self-monitoring', 'Smartphone-Enhanced Symptom Management', 'active symptom monitoring']","['adherence rate', 'positive psychotic symptoms', 'psychotic symptom improvement', 'empowerment scale', 'positive score on the Positive and Negative Syndrome Scale (PANSS) scale']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}]",181.0,0.117585,"At 12 weeks, 90% (33/36) of those in the active monitoring group continued to use the system and exhibited an adherence rate (defined as responding to >33% of alerts) of 84% (30/36}. Active symptom monitoring was associated with no difference on the empowerment scale in comparison to the usual management group at 12 weeks.","[{'ForeName': 'Shon', 'Initials': 'S', 'LastName': 'Lewis', 'Affiliation': 'Manchester Academic Health Sciences Centre, Greater Manchester Mental Health Foundation Trust, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ainsworth', 'Affiliation': 'Manchester Academic Health Sciences Centre, Greater Manchester Mental Health Foundation Trust, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Sanders', 'Affiliation': 'Manchester Academic Health Sciences Centre, Greater Manchester Mental Health Foundation Trust, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Stockton-Powdrell', 'Affiliation': 'Manchester Academic Health Sciences Centre, Greater Manchester Mental Health Foundation Trust, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Machin', 'Affiliation': 'Manchester Academic Health Sciences Centre, Greater Manchester Mental Health Foundation Trust, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Whelan', 'Affiliation': 'Manchester Academic Health Sciences Centre, Greater Manchester Mental Health Foundation Trust, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hopkins', 'Affiliation': 'Manchester Academic Health Sciences Centre, Greater Manchester Mental Health Foundation Trust, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Eve', 'Initials': 'E', 'LastName': 'Applegate', 'Affiliation': 'Manchester Academic Health Sciences Centre, Greater Manchester Mental Health Foundation Trust, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Drake', 'Affiliation': 'Manchester Academic Health Sciences Centre, Greater Manchester Mental Health Foundation Trust, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Bamford', 'Affiliation': 'Manchester Academic Health Sciences Centre, Greater Manchester Mental Health Foundation Trust, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': 'Manchester Academic Health Sciences Centre, Greater Manchester Mental Health Foundation Trust, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Til', 'Initials': 'T', 'LastName': 'Wykes', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, United Kingdom.""}]",Journal of medical Internet research,['10.2196/17019']
2330,32788162,Thrombolysis with alteplase 3-4.5 hours after acute ischaemic stroke: trial reanalysis adjusted for baseline imbalances.,,2020,,[],[],[],[],[],[],,0.0806821,,"[{'ForeName': 'Daniel Michael', 'Initials': 'DM', 'LastName': 'Fatovich', 'Affiliation': 'Emergency Medicine, Faculty of Health and Medical Sciences, Royal Perth Hospital, University of Western Australia, Perth, Western Australia, Australia daniel.fatovich@health.wa.gov.au.'}, {'ForeName': 'Wm Ken', 'Initials': 'WK', 'LastName': 'Milne', 'Affiliation': 'Department of Medicine, Western University, London, Ontario, Canada.'}]",BMJ evidence-based medicine,['10.1136/bmjebm-2020-111517']
2331,32788190,Transmission reduction and prevention with HPV vaccination (TRAP-HPV) study protocol: a randomised controlled trial of the efficacy of HPV vaccination in preventing transmission of HPV infection in heterosexual couples.,"INTRODUCTION


Human papillomavirus (HPV) is a causal agent of malignancies including cervical, vulvar, vaginal, penile, anal and oropharyngeal cancer, as well as benign conditions such as anogenital warts. HPV vaccination protects individuals against infections with the target HPV types and their clinical outcomes. However, little is known about the protection an immunised individual confers to their sexual partner or its impact on HPV transmission dynamics. In this context, the Transmission Reduction and Prevention with HPV vaccination (TRAP-HPV) study was designed to determine the efficacy of an HPV vaccine in reducing transmission of genital and oral HPV infection in sexual partners of vaccinated individuals.
METHODS AND ANALYSIS


The TRAP-HPV study is an ongoing randomised controlled trial among heterosexual couples living in Montreal, Canada. Sexually active couples, aged between 18 and 45 years, who have been in a relationship no longer than 6 months are considered eligible. Participants are independently randomised to receive either the intervention HPV vaccine, Gardasil 9, or a placebo hepatitis A vaccine, Avaxim, creating four vaccination groups among couples: intervention-intervention, intervention-placebo, placebo-intervention and the placebo-placebo. Participants provide genital (vaginal/penile) and oral samples at baseline and five follow-up visits over a 1-year duration. Linear Array HPV genotyping is used to detect 36 HPV types. Cox proportional hazard regression models will be used to estimate the effect of vaccination on HPV transmission.
ETHICS AND DISSEMINATION


The TRAP-HPV study received ethical approval by institutional review boards McGill University, Concordia University and Centre Hospitalier de l'Université de Montréal. Before enrolment, all participants provide informed written consent. Results will be published in peer-reviewed journals and presented at national and international conferences. The generated empirical evidence could be used in mathematical models of vaccination to inform policymakers in Canada and elsewhere.
TRIAL REGISTRATION NUMBER


NCT01824537.",2020,"Participants are independently randomised to receive either the intervention HPV vaccine, Gardasil 9, or a placebo hepatitis A vaccine, Avaxim, creating four vaccination groups among couples: intervention-intervention, intervention-placebo, placebo-intervention and the placebo-placebo.","['heterosexual couples living in Montreal, Canada', 'sexual partners of vaccinated individuals', 'heterosexual couples', 'Sexually active couples, aged between 18 and 45 years, who have been in a relationship no longer than 6 months are considered eligible']","['HPV vaccination (TRAP-HPV', 'intervention HPV vaccine, Gardasil 9, or a placebo hepatitis A vaccine, Avaxim, creating four vaccination groups among couples: intervention-intervention, intervention-placebo, placebo-intervention and the placebo-placebo', 'HPV vaccination', 'HPV vaccine']",['transmission of genital and oral HPV infection'],"[{'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0241028', 'cui_str': 'Sexually active'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C1275126', 'cui_str': 'TNF receptor-associated periodic fever syndrome (TRAPS)'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C3864947', 'cui_str': 'Gardasil 9'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0170300', 'cui_str': 'Hepatitis A Vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0343641', 'cui_str': 'Human papilloma virus infection'}]",,0.257928,"Participants are independently randomised to receive either the intervention HPV vaccine, Gardasil 9, or a placebo hepatitis A vaccine, Avaxim, creating four vaccination groups among couples: intervention-intervention, intervention-placebo, placebo-intervention and the placebo-placebo.","[{'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'MacCosham', 'Affiliation': 'Division of Cancer Epidemiology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'El-Zein', 'Affiliation': 'Division of Cancer Epidemiology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Ann N', 'Initials': 'AN', 'LastName': 'Burchell', 'Affiliation': ""Department of Family and Community Medicine and Centre for Research on Inner City Health, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Pierre-Paul', 'Initials': 'PP', 'LastName': 'Tellier', 'Affiliation': 'Family Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Coutlée', 'Affiliation': ""Service de Microbiologie Médicale et Service d'Infectiologie, Départements de Médecine et de Médecine de Laboratoire, Centre Hospitalier de L'Universite de Montreal, Montreal, Quebec, Canada.""}, {'ForeName': 'Eduardo L', 'Initials': 'EL', 'LastName': 'Franco', 'Affiliation': 'Division of Cancer Epidemiology, McGill University, Montreal, Quebec, Canada eduardo.franco@mcgill.ca.'}]",BMJ open,['10.1136/bmjopen-2020-039383']
2332,32788567,Levosimendan in the treatment of patients with acute cardiac conditions: an expert opinion of the Association of Intensive Cardiac Care of the Polish Cardiac Society.,"Levosimendan is a new inodilator which acts by three main mechanisms: increase calcium sensitivity of cardiomyocytes, acts as a vasodilator due to the opening of potassium channels, and possesses the cardioprotective action. Levosimendan has found its indication mainly in the treatment of acute, decompensated heart failure (indication IIb according to ESC guidelines). However, the results of many clinical trials indicate the validity of using repeated infusions of levosimendan in patients with stable heart failure, as a bridge therapy to heart transplantation, also in patients with accompanying right ventricle heart failure and pulmonary hypertension. Due to the complex mechanism of action, including the cardioprotective and anti-aggregating effect, the use of levosimandan may be particularly beneficial in patients with acute coronary syndromes, preventing the occurrence of acute heart failure. Several data indicate that levosimendan administered prior to cardiac surgery may improve outcomes in patients with severely impaired left ventricle function. The multidirectional mechanism of action also affects other organs and systems. The positive effect of levosimendan in the treatment of cardio-renal and cardio-hepatic syndromes has been demonstrated.  Levosimendan has a safe and predictable profile of action, does not induce tolerance, and shows no adverse effects affecting patients survival or prognosis. However, with inconclusive results of the previous studies, there is a need to conduct a properly designed, multicentre, randomized, placebo-controlled study, including an adequately large group of outpatients with chronic advanced systolic heart failure.",2020,"Levosimendan has a safe and predictable profile of action, does not induce tolerance, and shows no adverse effects affecting patients survival or prognosis.","['patients with accompanying right ventricle heart failure and pulmonary hypertension', 'patients with stable heart failure', 'patients with acute coronary syndromes', 'patients with severely impaired left ventricle function', 'patients with acute cardiac conditions', 'outpatients with chronic advanced systolic heart failure']","['levosimendan', 'Levosimendan', 'levosimandan', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0225883', 'cui_str': 'Right cardiac ventricular structure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0225897', 'cui_str': 'Left cardiac ventricular structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1135191', 'cui_str': 'Systolic heart failure'}]","[{'cui': 'C0246904', 'cui_str': 'Levosimendan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0197177,"Levosimendan has a safe and predictable profile of action, does not induce tolerance, and shows no adverse effects affecting patients survival or prognosis.","[{'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Tycińska', 'Affiliation': ''}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Gierlotka', 'Affiliation': ''}, {'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Bugajski', 'Affiliation': ''}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Deja', 'Affiliation': ''}, {'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Depukat', 'Affiliation': ''}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Gruchała', 'Affiliation': ''}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Grześk', 'Affiliation': ''}, {'ForeName': 'Jarosław D', 'Initials': 'JD', 'LastName': 'Kasprzak', 'Affiliation': ''}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Kubica', 'Affiliation': ''}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Kucewicz-Czech', 'Affiliation': ''}, {'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Leszek', 'Affiliation': ''}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Płonka', 'Affiliation': ''}, {'ForeName': 'Bożena', 'Initials': 'B', 'LastName': 'Sobkowicz', 'Affiliation': ''}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Straburzyńska-Migaj', 'Affiliation': ''}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Wilk', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Zawiślak', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zymliński', 'Affiliation': ''}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Stępińska', 'Affiliation': ''}]",Kardiologia polska,['10.33963/KP.15551']
2333,32788673,Correction: Prevention of obesity in toddlers (PROBIT): a randomised clinical trial of responsive feeding promotion from birth to 24 months.,"In the original Article, Dr. Laura Fontana's name was missing from the author list. This has been corrected (Dr. Fontana's name and details have been added to the HTML, PDF and XML version of this Article).",2020,"This has been corrected (Dr. Fontana's name and details have been added to the HTML, PDF and XML version of this Article).",['obesity in toddlers (PROBIT'],[],[],"[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}]",[],[],,0.0210562,"This has been corrected (Dr. Fontana's name and details have been added to the HTML, PDF and XML version of this Article).","[{'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Morandi', 'Affiliation': 'Pediatric Diabetes and Metabolic Disorders Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Tommasi', 'Affiliation': 'Pediatric Diabetes and Metabolic Disorders Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Soffiati', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Florinda', 'Initials': 'F', 'LastName': 'Destro', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Fontana', 'Affiliation': 'Pediatric Diabetes and Metabolic Disorders Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Grando', 'Affiliation': 'Dolomiti Local Health and Social Care Service, Belluno, Italy.'}, {'ForeName': 'Giustina', 'Initials': 'G', 'LastName': 'Simonetti', 'Affiliation': 'Dolomiti Local Health and Social Care Service, Belluno, Italy.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Bucolo', 'Affiliation': 'Euganea Local Health and Social Care Service, Padua, Italy.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Alberti', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Baraldi', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Antonietta', 'Initials': 'A', 'LastName': 'Chiriacò', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Ferrarese', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Graziana', 'Initials': 'G', 'LastName': 'Frignani', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Pasqualini', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Rossi', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Siciliano', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Zuccolo', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Giuliana', 'Initials': 'G', 'LastName': 'Matticchio', 'Affiliation': 'Berica Local Health and Social Care Service, Vicenza, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Vettori', 'Affiliation': 'Berica Local Health and Social Care Service, Vicenza, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Danieli', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Guarda', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Iuliano', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Raimo', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Sirpresi', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Trevisan', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Vinco', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Maffeis', 'Affiliation': 'Pediatric Diabetes and Metabolic Disorders Unit, University Hospital of Verona, Verona, Italy. Claudio.maffeis@univr.it.'}]",International journal of obesity (2005),['10.1038/s41366-020-00651-y']
2334,32788743,Efficacy and safety of continuous antiviral therapy from preconception to prevent perinatal transmission of hepatitis B virus.,"Few studies were conducted to assess safety and efficacy of continuous antiviral therapy administrated from preconception. In the present study, 136 eligible women with chronic HBV infection were recruited, and assigned to active chronic hepatitis B (CHB) (Group A, B or C) or chronic HBV carrier (Group D). Antiviral therapy was administrated in preconception (Group A), in early (Group B) or late pregnancy (Group C and Group D). Immunoprophylaxis was administrated to all infants. Mothers' HBV status and ALT were assessed at delivery and 7 months postpartum. Offspring's HBV status was examined at 7 months old. Group A women showed low HBV DNA level and normal ALT throughout pregnancy. All women at delivery had an HBV DNA level of less than 10 6  IU/ml, but the proportion of patients with lower HBV DNA level in Group A was higher than any of other three groups (P < 0.05). No differences in obstetrical complications were found among the four groups. None of infants who completed follow-up showed positive HBsAg at age of 7 months. Congenital malformation and infant growth indicators were similar among study cohorts. Continuous antiviral therapy from preconception to entire pregnancy is effective and safe for active CHB mothers and their infants.",2020,Continuous antiviral therapy from preconception to entire pregnancy is effective and safe for active CHB mothers and their infants.,"['136 eligible women with chronic HBV infection were recruited, and assigned to active chronic hepatitis B (CHB', 'active CHB mothers and their infants']","['Antiviral therapy', 'Immunoprophylaxis', 'continuous antiviral therapy']","['low HBV DNA level and normal ALT', 'positive HBsAg', 'Congenital malformation and infant growth indicators', 'HBV DNA level', 'Efficacy and safety', 'obstetrical complications', 'safety and efficacy', ""Mothers' HBV status and ALT""]","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0520463', 'cui_str': 'Chronic active hepatitis'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0280274', 'cui_str': 'Antiviral therapy'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0178292', 'cui_str': 'Complication of pregnancy, childbirth and/or the puerperium'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",136.0,0.0306027,Continuous antiviral therapy from preconception to entire pregnancy is effective and safe for active CHB mothers and their infants.,"[{'ForeName': 'Xingfei', 'Initials': 'X', 'LastName': 'Pan', 'Affiliation': 'Department of Infectious Diseases, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Jingsi', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Fetal Medicine and Prenatal Diagnosis, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Liyang', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Infectious Diseases, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Xueting', 'Initials': 'X', 'LastName': 'Ou', 'Affiliation': 'Department of Infectious Diseases, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'He', 'Affiliation': 'The Medical Centre for Critical Pregnant Women in Guangzhou, Guangzhou, China.'}, {'ForeName': 'Yifen', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'The Medical Centre for Critical Pregnant Women in Guangzhou, Guangzhou, China.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Department of Infectious Diseases, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Haibin', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Fujian Provincial Laboratory for Reproductive Health Research, School of Medicine, Xiamen University, Xiamen, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': 'Fujian Provincial Laboratory for Reproductive Health Research, School of Medicine, Xiamen University, Xiamen, China.'}, {'ForeName': 'Zhijian', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Huishu', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Obstetrics and Gynecology, Guangzhou Women and Children's Medical Center, Guangzhou, China.""}, {'ForeName': 'Guocheng', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': ""Department of Obstetrics and Gynecology, Guangdong Provincial Maternal and Children's Hospital, Guangzhou, China.""}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Obstetrics and Gynecology, Beijing TsingHua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Guanxin', 'Initials': 'G', 'LastName': 'Shen', 'Affiliation': 'Department of Immunology, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shiliang', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Dunjin', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory for Major Obstetric Diseases of Guangdong Province, Guangzhou, China. gzdrchen@gzhmu.edu.cn.'}]",Scientific reports,['10.1038/s41598-020-70644-4']
2335,32788855,RANDOMIZED CONTROLLED TRIAL OF LIMITED FASCIOTOMY WITH INJECTION OF ADIPOSE GRAFT FOR DUPUYTREN'S DISEASE.,"Objective


Dupuytren's disease is a genetic disorder related to the proliferation of myofibroblasts. The pluripotent property of stem cells present in adipose tissue inhibits myofibroblast proliferation. Our study sought to evaluate the effect of stem cell-rich fat grafts in patients that underwent limited fasciotomy.
Methods


We studied 45 patients, in a single-blind, prospective, randomized clinical trial. All patients underwent limited fasciotomy. In one group, fat graft was injected.
Results


The total passive extension deficit results did not exhibit a significant difference. Fat group exhibited worse functional score at 6 months and 1 year postoperatively, such as higher complication rates (43%), when compared with control group (8%), and more pain at 6 weeks follow-up.
Conclusion


Fat grafting associated with limited fasciotomy promotes worse functional results compared to conventional limited fasciotomy in the short term. However, long-term results and recurrence rates should be further assessed. Level of Evidence II, Prospective comparative study.",2020,"Fat group exhibited worse functional score at 6 months and 1 year postoperatively, such as higher complication rates (43%), when compared with control group (8%), and more pain at 6 weeks follow-up.
","['45 patients', 'patients that underwent limited fasciotomy']",['stem cell-rich fat grafts'],"['complication rates', 'total passive extension deficit', 'recurrence rates', 'pain', 'functional score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0185188', 'cui_str': 'Division of fascia'}]","[{'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0844767', 'cui_str': 'Grafting of fat'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",45.0,0.0951548,"Fat group exhibited worse functional score at 6 months and 1 year postoperatively, such as higher complication rates (43%), when compared with control group (8%), and more pain at 6 weeks follow-up.
","[{'ForeName': 'Marina Tommasini C', 'Initials': 'MTC', 'LastName': 'Sambuy', 'Affiliation': 'Universidade de São Paulo, Medical School, Hospital das Clínicas, Institute of Orthopedics and Traumatology, São Paulo, SP, Brazil.'}, {'ForeName': 'Hugo A', 'Initials': 'HA', 'LastName': 'Nakamoto', 'Affiliation': 'Universidade de São Paulo, Medical School, Hospital das Clínicas, Institute of Orthopedics and Traumatology, São Paulo, SP, Brazil.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Bolliger', 'Affiliation': 'Universidade de São Paulo, Medical School, Hospital das Clínicas, Institute of Orthopedics and Traumatology, São Paulo, SP, Brazil.'}, {'ForeName': 'Rames', 'Initials': 'R', 'LastName': 'Mattar', 'Affiliation': 'Universidade de São Paulo, Medical School, Hospital das Clínicas, Institute of Orthopedics and Traumatology, São Paulo, SP, Brazil.'}, {'ForeName': 'Marcelo R', 'Initials': 'MR', 'LastName': 'Rezende', 'Affiliation': 'Universidade de São Paulo, Medical School, Hospital das Clínicas, Institute of Orthopedics and Traumatology, São Paulo, SP, Brazil.'}, {'ForeName': 'Teng Hsiang', 'Initials': 'TH', 'LastName': 'Wei', 'Affiliation': 'Universidade de São Paulo, Medical School, Hospital das Clínicas, Institute of Orthopedics and Traumatology, São Paulo, SP, Brazil.'}]",Acta ortopedica brasileira,['10.1590/1413-785220202804233522']
2336,32788865,Resveratrol reduces inflammation-related Prostate Fibrosis.,"Inflammation-related prostate fibrosis (PF) is strongly associated with impaired urethral function and lower urinary tract symptoms (LUTS) severity. The aim of this study was to investigate the effects of RSV in patients with small prostate volume and LUTS. Sixty-four patients with PF were randomized either to RSV therapy (group A= 32 patients) or placebo (group B= 32 patients). At baseline (T0) and after 2-months (T2), patients of both groups underwent administration of NIH-Chronic Prostatic Symptom Index (NIH-CPSI) and International Prostate Symptom Score (IPSS) questionnaires for prostatitis and LUTS, respectively, and Expressed Prostatic Secretion (EPS) assays. After two months, only, group A patients treated with RSV showed significant symptomatic improvement of all NIH-CPSI and IPSS subscale scores, as well as a better EPS assay after prostate massage, in terms of high amount of prostatic volume and reduced white blood cells counts. Our data suggested pharmacological advantage after 2-month treatment with RSV in selected patients with PF for the treatment of voiding and storage complaints.",2020,"After two months, only, group A patients treated with RSV showed significant symptomatic improvement of all NIH-CPSI and IPSS subscale scores, as well as a better EPS assay after prostate massage, in terms of high amount of prostatic volume and reduced white blood cells counts.","['Sixty-four patients with PF', 'patients with small prostate volume and LUTS']","['RSV therapy', 'RSV', 'placebo']","['prostatic volume and reduced white blood cells counts', 'symptomatic improvement of all NIH-CPSI and IPSS subscale scores', 'NIH-Chronic Prostatic Symptom Index (NIH-CPSI) and International Prostate Symptom Score (IPSS) questionnaires']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0426733', 'cui_str': 'Small prostate'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}]","[{'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",64.0,0.0317072,"After two months, only, group A patients treated with RSV showed significant symptomatic improvement of all NIH-CPSI and IPSS subscale scores, as well as a better EPS assay after prostate massage, in terms of high amount of prostatic volume and reduced white blood cells counts.","[{'ForeName': 'Enzo', 'Initials': 'E', 'LastName': 'Vicari', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Catania, 95123 Catania, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Arancio', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Catania, 95123 Catania, Italy.'}, {'ForeName': 'Vito Emanuele', 'Initials': 'VE', 'LastName': 'Catania', 'Affiliation': 'Department of Medical, Surgical Sciences and Advanced Technologies ""G.F. Ingrassia"", University of Catania, 95123 Catania, Italy.'}, {'ForeName': 'Beatrice Ornella', 'Initials': 'BO', 'LastName': 'Vicari', 'Affiliation': 'Research Centre ""The Great Senescence"", University of Catania, 95126 Catania, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Sidoti', 'Affiliation': 'UOSD Medicina Interna Ambulatorio Andrologia & Endocrinologia ARNAS-Garibaldi, 95123 Catania, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Castiglione', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Catania, 95123 Catania, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Malaguarnera', 'Affiliation': 'Research Centre ""The Great Senescence"", University of Catania, 95126 Catania, Italy.'}]",International journal of medical sciences,['10.7150/ijms.44443']
2337,32789011,Optimised patient information materials and recruitment to a study of behavioural activation in older adults: an embedded study within a trial.,"Background:  Printed participant information about randomised controlled trials is often long, technical and difficult to navigate. Improving information materials is possible through optimisation and user-testing, and may impact on participant understanding and rates of recruitment.  Methods:  A study within a trial (SWAT) was undertaken within the CASPER trial. Potential CASPER participants were randomised to receive either the standard trial information or revised information that had been optimised through information design and user testing.  Results:  A total of 11,531 patients were randomised in the SWAT. Rates of recruitment to the CASPER trial were 2.0% in the optimised information group and 1.9% in the standard information group (odds ratio 1.027; 95% CI 0.79 to 1.33; p=0.202).  Conclusions:  Participant information that had been optimised through information design and user testing did not result in any change to rate of recruitment to the host trial.  Registration:  ISRCTN ID ISRCTN02202951; registered on 3 June 2009.",2020,Rates of recruitment to the CASPER trial were 2.0% in the optimised information group and 1.9% in the standard information group (odds ratio 1.027; 95% CI 0.79 to 1.33; p=0.202).  ,"['11,531 patients', 'older adults', 'Potential CASPER participants']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]",[],[],11531.0,0.400413,Rates of recruitment to the CASPER trial were 2.0% in the optimised information group and 1.9% in the standard information group (odds ratio 1.027; 95% CI 0.79 to 1.33; p=0.202).  ,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Knapp', 'Affiliation': 'Department of Health Sciences and the Hull York Medical School, University of York,, York, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gilbody', 'Affiliation': 'Department of Health Sciences and the Hull York Medical School, University of York,, York, UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Holt', 'Affiliation': 'School of Healthcare, University of Leeds, Leeds, UK.'}, {'ForeName': 'Ada', 'Initials': 'A', 'LastName': 'Keding', 'Affiliation': 'Department of Health Sciences and the Hull York Medical School, University of York,, York, UK.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Mitchell', 'Affiliation': 'Department of Health Sciences and the Hull York Medical School, University of York,, York, UK.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Raynor', 'Affiliation': 'School of Healthcare, University of Leeds, Leeds, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Silcock', 'Affiliation': 'School of Pharmacy and Medical Sciences, University of Bradford, Bradford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torgerson', 'Affiliation': 'Department of Health Sciences and the Hull York Medical School, University of York,, York, UK.'}]",F1000Research,['10.12688/f1000research.24051.1']
2338,32789761,"Non-dispensing pharmacist integrated in the primary care team: effect on the quality of physician's prescribing, a non-randomised comparative study.","Background Especially in elderly with polypharmacy, medication can do harm. Clinical pharmacists integrated in primary care teams might improve quality of pharmaceutical care. Objective To assess the effect of non-dispensing clinical pharmacists integrated in primary care teams on general practitioners' prescribing quality. Setting This study was conducted in 25 primary care practices in the Netherlands. Methods Non-randomised, controlled, multi-centre, complex intervention study with pre-post comparison. First, we identified potential prescribing quality indicators from the literature and assessed their feasibility, validity, acceptability, reliability and sensitivity to change. Also, an expert panel assessed the indicators' health impact. Next, using the final set of indicators, we measured the quality of prescribing in practices where non-dispensing pharmacists were integrated in the team (intervention group) compared to usual care (two control groups). Data were extracted anonymously from the healthcare records. Comparisons were made using mixed models correcting for potential confounders. Main outcome measure Quality of prescribing, measured with prescribing quality indicators. Results Of 388 eligible indicators reported in the literature we selected 8. In addition, two more indicators relevant for Dutch general practice were formulated by an expert panel. Scores on all 10 indicators improved in the intervention group after introduction of the non-dispensing pharmacist. However, when compared to control groups, prescribing quality improved solely on the indicator measuring monitoring of the renal function in patients using antihypertensive medication: relative risk of a monitored renal function in the intervention group compared to usual care: 1.03 (95% CI 1.01-1.05, p-value 0.010) and compared to usual care plus: 1.04 (1.01-1.06, p-value 0.004). Conclusion This study did not demonstrate a consistent effect of the introduction of non-dispensing clinical pharmacists in the primary care team on the quality of physician's prescribing.This study is part of the POINT-study, which was registered at The Netherlands National Trial Register with trial registration number NTR-4389.",2020,This study did not demonstrate a consistent effect of the introduction of non-dispensing clinical pharmacists in the primary care team on the quality of physician's prescribing.,"['388 eligible indicators reported in the literature we selected 8', '25 primary care practices in the Netherlands']",[],"['feasibility, validity, acceptability, reliability and sensitivity to change', 'renal function', 'Quality of prescribing, measured with prescribing quality indicators']","[{'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0023866', 'cui_str': 'Literature'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]",[],"[{'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",388.0,0.0839224,This study did not demonstrate a consistent effect of the introduction of non-dispensing clinical pharmacists in the primary care team on the quality of physician's prescribing.,"[{'ForeName': 'Vivianne M', 'Initials': 'VM', 'LastName': 'Sloeserwij', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (UMCU), Utrecht University, Universiteitsweg 100, 3584 CG, Utrecht, The Netherlands. v.sloeserwij@umcutrecht.nl.'}, {'ForeName': 'Dorien L M', 'Initials': 'DLM', 'LastName': 'Zwart', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (UMCU), Utrecht University, Universiteitsweg 100, 3584 CG, Utrecht, The Netherlands.'}, {'ForeName': 'Ankie C M', 'Initials': 'ACM', 'LastName': 'Hazen', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (UMCU), Utrecht University, Universiteitsweg 100, 3584 CG, Utrecht, The Netherlands.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Poldervaart', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (UMCU), Utrecht University, Universiteitsweg 100, 3584 CG, Utrecht, The Netherlands.'}, {'ForeName': 'Anne J', 'Initials': 'AJ', 'LastName': 'Leendertse', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (UMCU), Utrecht University, Universiteitsweg 100, 3584 CG, Utrecht, The Netherlands.'}, {'ForeName': 'Antoinette A', 'Initials': 'AA', 'LastName': 'de Bont', 'Affiliation': 'Erasmus School of Health Policy and Management, Erasmus University, Burgemeester Oudlaan 50, 3062 PA, Rotterdam, The Netherlands.'}, {'ForeName': 'Marcel L', 'Initials': 'ML', 'LastName': 'Bouvy', 'Affiliation': 'Department of Pharmaceutical Sciences, Utrecht University, Universiteitsweg 99, 3584 CG, Utrecht, The Netherlands.'}, {'ForeName': 'Niek J', 'Initials': 'NJ', 'LastName': 'de Wit', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (UMCU), Utrecht University, Universiteitsweg 100, 3584 CG, Utrecht, The Netherlands.'}, {'ForeName': 'Han J', 'Initials': 'HJ', 'LastName': 'de Gier', 'Affiliation': 'Department of Pharmacotherapy, -Epidemiology and -Economics, University of Groningen, Antonius Deusinglaan 1, Building 3214, 9713 AV, Groningen, The Netherlands.'}]",International journal of clinical pharmacy,['10.1007/s11096-020-01075-4']
2339,32789809,Pharmacokinetic and Pharmacodynamic Equivalence of Pegfilgrastim-cbqv and Pegfilgrastim in Healthy Subjects.,"INTRODUCTION


Pegfilgrastim-cbqv was developed as a biosimilar of pegfilgrastim, a pegylated form of recombinant human granulocyte colony-stimulating factor approved for decreasing febrile neutropenia-associated infection in patients receiving myelosuppressive drugs. This multicenter, randomized, single-blind, partial-reference-replicated, three-sequence crossover study assessed pharmacokinetic and pharmacodynamic bioequivalence of pegfilgrastim-cbqv and pegfilgrastim in healthy subjects.
METHODS


One hundred twenty-two subjects were randomized to one of three treatment sequences; each included one dose of pegfilgrastim-cbqv and two doses of pegfilgrastim separated by ≥ 28 days. The primary pharmacokinetic end points were area under the curve (AUC) from 0 to infinity (AUC 0-∞ ) and maximum concentration (C max ). The primary pharmacodynamic end points were maximum absolute neutrophil count (ANC max ) and ANC AUC from time 0 to the last measurable observation (ANC AUC 0-last ). Pharmacokinetic and pharmacodynamic bioequivalences were demonstrated if the 90% CI for the geometric mean ratio (GMR) of pegfilgrastim-cbqv to pegfilgrastim was within 80-125% for the primary end points.
RESULTS


Pharmacokinetic bioequivalence criteria were met for C max  (GMR 105.0; 90% CI 95.5-115.4) and AUC 0-∞  (GMR 97.5; 90% CI 88.6-107.2). Pharmacodynamic bioequivalence criteria were met for ANC max  (GMR 99.6; 90% CI 96.2-103.2) and ANC AUC 0-last  (GMR 96.7; 90% CI 92.2-101.4). Adverse events occurred in 76.0%, 76.6%, and 73.1% of subjects for pegfilgrastim-cbqv, first pegfilgrastim, and second pegfilgrastim dosing periods across treatment sequences, respectively. Investigators found no drug-related serious adverse events.
CONCLUSION


This study established pharmacokinetic and pharmacodynamic bioequivalence of pegfilgrastim-cbqv to pegfilgrastim. The treatments displayed similar safety profiles, including immunogenicity, with no unexpected safety findings.
CLINICAL TRIALS REGISTRATION


ClinicalTrials.gov, NCT02650973, February 2016.",2020,"Adverse events occurred in 76.0%, 76.6%, and 73.1% of subjects for pegfilgrastim-cbqv, first pegfilgrastim, and second pegfilgrastim dosing periods across treatment sequences, respectively.","['One hundred twenty-two subjects', 'patients receiving myelosuppressive drugs', 'healthy subjects', 'Healthy Subjects']","['pegfilgrastim-cbqv and pegfilgrastim', 'pegfilgrastim-cbqv and two doses of pegfilgrastim separated by\u2009≥', 'recombinant human granulocyte colony-stimulating factor', 'Pegfilgrastim-cbqv and Pegfilgrastim', 'pegfilgrastim-cbqv to pegfilgrastim']","['geometric mean ratio (GMR) of pegfilgrastim-cbqv to pegfilgrastim', 'area under the curve (AUC) from 0 to infinity (AUC 0-∞ ) and maximum concentration (C max ', 'Adverse events', 'pharmacokinetic and pharmacodynamic bioequivalence', 'Pharmacokinetic and pharmacodynamic bioequivalences', 'Pharmacokinetic and Pharmacodynamic Equivalence', 'maximum absolute neutrophil count (ANC max ) and ANC AUC from time 0 to the last measurable observation (ANC AUC 0-last ']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4735048', 'cui_str': 'pegfilgrastim-cbqv'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C1271481', 'cui_str': 'Recombinant human granulocyte colony stimulating factor'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4735048', 'cui_str': 'pegfilgrastim-cbqv'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]",122.0,0.0612766,"Adverse events occurred in 76.0%, 76.6%, and 73.1% of subjects for pegfilgrastim-cbqv, first pegfilgrastim, and second pegfilgrastim dosing periods across treatment sequences, respectively.","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Finck', 'Affiliation': 'Coherus BioSciences, Redwood City, CA, USA. bfinck@coherus.com.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'Coherus BioSciences, Redwood City, CA, USA.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Civoli', 'Affiliation': 'Coherus BioSciences, Redwood City, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hodge', 'Affiliation': 'Coherus BioSciences, Redwood City, CA, USA.'}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': ""O'Kelly"", 'Affiliation': 'Coherus BioSciences, Redwood City, CA, USA.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Vexler', 'Affiliation': 'Coherus BioSciences, Redwood City, CA, USA.'}]",Advances in therapy,['10.1007/s12325-020-01459-y']
2340,32789898,Exercise training-induced visceral fat loss in obese women: the role of training intensity and modality.,"Visceral fat loss in response to four cycle ergometer training regimens with explicit differences in exercise intensity and modality were compared. 59 obese young women (body fat percentage ≥30%) were randomized to a 12-wk intervention consisting of either all-out sprint interval training (SIT all-out  , n=11); supramaximal SIT (SIT 120  , 120% V̇O 2peak  , n=12); high-intensity interval training (HIIT 90  , 90% V̇O 2peak  , n=12), moderate-intensity continuous training (MICT, 60% V̇O 2peak  , n=11), or no training (CON, n=13). The total work done per training session in SIT 120  , HIIT 90  , and MICT was confined to 200 KJ, while it was deliberately lower in SIT all-out  . The abdominal visceral fat area (AVFA) was measured through computed tomography scans. The whole-body and regional fat mass were assessed through dual-energy X-ray absorptiometry. Pre-, post-, and 3-hr post-exercise serum growth hormone (GH), and epinephrine (EPI) were measured during selected training sessions. Following the intervention, similar reductions in whole-body and regional fat mass were found in all intervention groups, while the reductions in AVFA resulting from SIT all-out  , SIT 120  , and HIIT 90  (> 15 cm 2  ) were greater in comparison to MICT (< 3.5 cm 2  , P < 0.05). The AVFA reductions among the SITs and HIIT groups were similar, and it was concomitant with the similar exercise-induced releases of serum GH and EPI. CON variables were unchanged. These findings suggest that visceral fat loss induced by interval training at or above 90% V̇O 2peak  appeared unresponsive to the change in training intensity. Nonetheless, SIT all-out  is still the most time-efficient strategy among the four exercise-training regimes for controlling visceral obesity.",2020,"Following the intervention, similar reductions in whole-body and regional fat mass were found in all intervention groups, while the reductions in AVFA resulting from SIT all-out  , SIT 120  , and HIIT 90  (> 15 cm 2  ) were greater in comparison to MICT (< 3.5 cm 2  , P < 0.05).","['59 obese young women (body fat percentage ≥30', 'obese women']","['12-wk intervention consisting of either all-out sprint interval training (SIT all-out  , n=11); supramaximal SIT (SIT 120  , 120% V̇O 2peak  , n=12); high-intensity interval training (HIIT 90  , 90% V̇O 2peak  , n=12), moderate-intensity continuous training (MICT, 60% V̇O 2peak  , n=11), or no training (CON', 'Exercise training']","['AVFA reductions', 'serum GH and EPI', 'abdominal visceral fat area (AVFA', 'Pre-, post-, and 3-hr post-exercise serum growth hormone (GH), and epinephrine (EPI', 'whole-body and regional fat mass', 'AVFA', 'CON variables', 'visceral fat loss']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0428401', 'cui_str': 'Serum growth hormone measurement'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",59.0,0.0166076,"Following the intervention, similar reductions in whole-body and regional fat mass were found in all intervention groups, while the reductions in AVFA resulting from SIT all-out  , SIT 120  , and HIIT 90  (> 15 cm 2  ) were greater in comparison to MICT (< 3.5 cm 2  , P < 0.05).","[{'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Physical Education College, Hebei Normal University, Shijiazhuang, China.'}, {'ForeName': 'Tomas K', 'Initials': 'TK', 'LastName': 'Tong', 'Affiliation': 'Department of Sports, Physical Education and Health, Hong Kong Baptist University, Hong Kong, China.'}, {'ForeName': 'Zhaowei', 'Initials': 'Z', 'LastName': 'Kong', 'Affiliation': 'Faculty of Education, University of Macau, Macao, China.'}, {'ForeName': 'Qingde', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'School of Health Sciences and Sports, Macao Polytechnic Institute, Macao, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Physical Education College, Hebei Normal University, Shijiazhuang, China.'}, {'ForeName': 'Jinlei', 'Initials': 'J', 'LastName': 'Nie', 'Affiliation': 'School of Health Sciences and Sports, Macao Polytechnic Institute, Macao, China.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13803']
2341,32787610,Early experience of pump-controlled retrograde trial off for weaning from veno-arterial extracorporeal membrane oxygenation in adult patients with cardiogenic shock.,"INTRODUCTION


Pump-controlled retrograde trial off has recently been introduced as an effective method for weaning from veno-arterial extracorporeal membrane oxygenation in pediatric patients. However, studies on pump-controlled retrograde trial off in adults are still lacking. Thus, this study aimed to examine the outcomes of pump-controlled retrograde trial off for weaning from veno-arterial extracorporeal membrane oxygenation in adult patients.
METHODS


Between January 2018 and July 2019, 87 consecutive adult patients underwent veno-arterial extracorporeal membrane oxygenation support, of whom 47 (54.0%) underwent pump-controlled retrograde trial off for weaning from extracorporeal membrane oxygenation and were enrolled in this study. The pump-controlled retrograde trial off results, extracorporeal membrane oxygenation reapplication rate, and clinical outcomes were analyzed.
RESULTS


Of the 47 patients, 38 (80.9%) were weaned from veno-arterial extracorporeal membrane oxygenation on the first attempt of pump-controlled retrograde trial off, 5 (10.6%) on the second attempt, and 4 (8.5%) on the third attempt. Three patients were converted to venovenous extracorporeal membrane oxygenation by desaturation but had stable blood pressure during pump-controlled retrograde trial off. No extracorporeal membrane oxygenation reapplication was performed within 3 days after removal, and two patients underwent veno-arterial extracorporeal membrane oxygenation during follow-up. No complications associated with pump-controlled retrograde trial off occurred during the weaning process, including thromboembolic events. Five in-hospital deaths (10.6%) occurred after weaning from extracorporeal membrane oxygenation.
CONCLUSION


Pump-controlled retrograde trial off is an effective method to safely wean from veno-arterial extracorporeal membrane oxygenation in adult patients. It is simple and can be easily implemented without additional invasive procedures and may help prevent deterioration of the cardiovascular system after weaning from veno-arterial extracorporeal membrane oxygenation.",2020,It is simple and can be easily implemented without additional invasive procedures and may help prevent deterioration of the cardiovascular system after weaning from veno-arterial extracorporeal membrane oxygenation.,"['87 consecutive adult patients underwent veno-arterial extracorporeal membrane oxygenation support, of whom 47 (54.0%) underwent pump-controlled retrograde trial off for weaning from extracorporeal membrane oxygenation and were enrolled in this study', 'pediatric patients', 'adult patients', 'adult patients with cardiogenic shock', 'Of the 47 patients, 38 (80.9%) were weaned from veno-arterial extracorporeal membrane oxygenation on the first attempt of pump-controlled retrograde trial off, 5 (10.6%) on the second attempt, and 4 (8.5%) on the third attempt', 'Between January 2018 and July 2019']","['weaning from veno-arterial extracorporeal membrane oxygenation', 'venovenous extracorporeal membrane oxygenation']","['thromboembolic events', 'stable blood pressure']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5192097', 'cui_str': 'Venoarterial extracorporeal membrane oxygenation'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C4517877', 'cui_str': '8.5'}]","[{'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C5192097', 'cui_str': 'Venoarterial extracorporeal membrane oxygenation'}, {'cui': 'C5192099', 'cui_str': 'Venovenous extracorporeal membrane oxygenation'}]","[{'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0428896', 'cui_str': 'Stable blood pressure'}]",87.0,0.180057,It is simple and can be easily implemented without additional invasive procedures and may help prevent deterioration of the cardiovascular system after weaning from veno-arterial extracorporeal membrane oxygenation.,"[{'ForeName': 'Min Ho', 'Initials': 'MH', 'LastName': 'Ju', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Yangsan, Korea.'}, {'ForeName': 'Mi Hee', 'Initials': 'MH', 'LastName': 'Lim', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Yangsan, Korea.'}, {'ForeName': 'Soo Yong', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Cardiology, Pusan National University Yangsan Hospital, Yangsan, Korea.'}, {'ForeName': 'Chee-Hoon', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Yangsan, Korea.'}, {'ForeName': 'Hyung Gon', 'Initials': 'HG', 'LastName': 'Je', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Yangsan, Korea.'}]",Perfusion,['10.1177/0267659120941328']
2342,32787619,Burnout undermines empathising: do induced burnout symptoms impair cognitive and affective empathy?,"Empathy is crucial for the quality of social interactions and thus highly relevant in human service professions. At the same time, people belonging to this occupational group are especially vulnerable to developing burnout symptoms. With this study, we aimed to investigate the causal link between burnout symptoms and empathy by using a novel experimental design. Our participants ( N  = 355; 44.5% women;  M age   = 36.37) filled out an online questionnaire; in an autobiographical memory task, the experimental group retrieved previous burnout experiences, whereas one control group retrieved a neutral memory and another control group received no intervention. After measuring current burnout symptoms as a manipulation check, we measured the cognitive and affective empathy of all participants. Findings indicate that the experimental group reported significantly higher burnout symptoms compared to control groups, validating our intervention method. Furthermore, we found that the experimental group scored lower on one of the cognitive empathy measures, suggesting negative effects on the relational skills of burned-out individuals. Results are discussed with regard to ecological validity and implications.",2020,"Findings indicate that the experimental group reported significantly higher burnout symptoms compared to control groups, validating our intervention method.","['Our participants ( N \u2009=\u2009355; 44.5% women;  M age  \u2009=\u200936.37) filled out an online questionnaire; in an autobiographical memory task, the experimental group retrieved previous burnout experiences, whereas one control group retrieved a']",['neutral memory and another control group received no intervention'],"['cognitive and affective empathy', 'burnout symptoms', 'cognitive empathy measures']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0127837,"Findings indicate that the experimental group reported significantly higher burnout symptoms compared to control groups, validating our intervention method.","[{'ForeName': 'Mareike', 'Initials': 'M', 'LastName': 'Trauernicht', 'Affiliation': 'Department of Early Childhood Education, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Oppermann', 'Affiliation': 'Department of Early Childhood Education, Otto-Friedrich-Universität Bamberg, Bamberg, Germany.'}, {'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Klusmann', 'Affiliation': 'Department of Educational Research and Educational Psychology, Leibniz Institute for Science and Mathematics Education, Kiel, Germany.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Anders', 'Affiliation': 'Department of Early Childhood Education, Otto-Friedrich-Universität Bamberg, Bamberg, Germany.'}]",Cognition & emotion,['10.1080/02699931.2020.1806041']
2343,32787783,A randomised dose-response study of prophylactic Methoxamine infusion for preventing spinal-induced hypotension during Cesarean delivery.,"BACKGROUND


α-receptor agonists have been reported to be safe and effective for treating or preventing spinal-induced hypotension during cesarean delivery. As a pure α 1  adrenergic agonist, methoxamine has potential advantages of reducing myocardial oxygen consumption and protecting the heart in obstetric patients compared to phenylephrine. The aim of this study was to determine the optimal prophylactic methoxamine infusion dose that would be effective for preventing spinal-induced hypotension in 50% (ED 50 ) and 95% (ED 95 ) of parturients.
METHODS


Eighty parturients with a singleton pregnancy scheduled for elective cesarean delivery were randomly allocated to receive prophylactic methoxamine infusion at one of four different fixed-rates: 1 μg/kg/min (group M1), 2 μg/kg/min (group M2), 3 μg/kg/min (group M3), or 4 μg/kg/min (group M4). An adequate response was defined as absence of hypotension (maternal SBP < 80% of baseline or SBP < 90 mmHg). The values for ED 50  and ED 95  of prophylactic methoxamine infusion were determined by probit regression model. The outcomes of maternal hemodynamics and fetal status were compared among the groups.
RESULTS


The calculated ED 50  and ED 95  (95% confidence interval) of prophylactic methoxamine infusion dose were 2.178 (95% CI 1.564 to 2.680) μg/kg/min and 4.821 (95% CI 3.951 to 7.017) μg/kg/min, respectively. The incidence of hypotension decreased with increasing methoxamine infusion dose (15/20, 11/20, 7/20 and 2/20 in group M1, M2, M3 and M4 respectively, P <  0.001). 1-min Apgar scores and umbilical arterial PaO2 were lower but umbilical arterial PaCO2 was higher in Group M1. No difference was found in the other incidence of adverse effects and neonatal outcomes among groups.
CONCLUSIONS


Under the conditions of this study, when prophylactic methoxamine infusion was given at a fixed-rate based on body weight for preventing spinal-induced hypotension in obstetric patients, the values for ED 50  and ED 95  were 2.178 μg/kg/min and 4.821 μg/kg/min respectively.
CLINICAL TRIAL REGISTRATION


Chinese Clinical Trial Registry (ChiCTR), registry number of clinical trial: ChiCTR-1,800,018,988 , date of registration: October 20, 2018.",2020,1-min Apgar scores and umbilical arterial PaO2 were lower but umbilical arterial PaCO2 was higher in Group M1.,"['spinal-induced hypotension during Cesarean delivery', 'Eighty parturients with a singleton pregnancy scheduled for elective cesarean delivery']","['prophylactic methoxamine infusion', 'prophylactic methoxamine', 'prophylactic Methoxamine infusion', 'phenylephrine']","['adverse effects and neonatal outcomes', 'myocardial oxygen consumption', '1-min Apgar scores and umbilical arterial PaO2', 'incidence of hypotension', 'maternal hemodynamics and fetal status', 'spinal-induced hypotension', 'umbilical arterial PaCO2']","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0025681', 'cui_str': 'Methoxamine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0428863', 'cui_str': 'Myocardial oxygen consumption'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",,0.308116,1-min Apgar scores and umbilical arterial PaO2 were lower but umbilical arterial PaCO2 was higher in Group M1.,"[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Fu', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Xueshi Rd 1#, Hangzhou, China.""}, {'ForeName': 'Yu-Wen', 'Initials': 'YW', 'LastName': 'Tang', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Xueshi Rd 1#, Hangzhou, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Xueshi Rd 1#, Hangzhou, China.""}, {'ForeName': 'Cui-Cui', 'Initials': 'CC', 'LastName': 'Jiao', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Xueshi Rd 1#, Hangzhou, China.""}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Ma', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Xueshi Rd 1#, Hangzhou, China.""}, {'ForeName': 'Xin-Zhong', 'Initials': 'XZ', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Xueshi Rd 1#, Hangzhou, China. chenxinz@zju.edu.cn.""}]",BMC anesthesiology,['10.1186/s12871-020-01119-2']
2344,32787809,An examination of the socio-demographic correlates of patient adherence to self-management behaviors and the mediating roles of health attitudes and self-efficacy among patients with coexisting type 2 diabetes and hypertension.,"BACKGROUND


Patients with coexisting type 2 diabetes and hypertension generally exhibit poor adherence to self-management, which adversely affects their disease control. Therefore, identification of the factors related to patient adherence is warranted. In this study, we aimed to examine (i) the socio-demographic correlates of patient adherence to a set of self-management behaviors relevant to type 2 diabetes and hypertension, namely, medication therapy, diet therapy, exercise, tobacco and alcohol avoidance, stress reduction, and self-monitoring/self-care, and (ii) whether health attitudes and self-efficacy in performing self-management mediated the associations between socio-demographic characteristics and adherence.
METHODS


We performed a secondary analysis of data collected in a randomized controlled trial. The sample comprised 148 patients with coexisting type 2 diabetes mellitus and hypertension. Data were collected by a questionnaire and analyzed using logistic regression.
RESULTS


Female patients were found to be less likely to exercise regularly (odds ratio [OR] = 0.49, P = 0.03) and more likely to avoid tobacco and alcohol (OR = 9.87, P < 0.001) than male patients. Older patients were found to be more likely to adhere to diet therapy (OR = 2.21, P = 0.01) and self-monitoring/self-care (OR = 2.17, P = 0.02). Patients living with family or others (e.g., caregivers) were found to be more likely to exercise regularly (OR = 3.44, P = 0.02) and less likely to avoid tobacco and alcohol (OR = 0.10, P = 0.04) than those living alone. Patients with better perceived health status were found to be more likely to adhere to medication therapy (OR = 2.02, P = 0.03). Patients with longer diabetes duration (OR = 2.33, P = 0.01) were found to be more likely to adhere to self-monitoring/self-care. Self-efficacy was found to mediate the association between older age and better adherence to diet therapy, while no significant mediating effects were found for health attitudes.
CONCLUSIONS


Adherence to self-management was found to be associated with socio-demographic characteristics (sex, age, living status, perceived health status, and diabetes duration). Self-efficacy was an important mediator in some of these associations, suggesting that patient adherence may be improved by increasing patients' self-management efficacy, such as by patient empowerment, collaborative care, or enhanced patient-physician interactions.",2020,"Older patients were found to be more likely to adhere to diet therapy (OR = 2.21, P = 0.01) and self-monitoring/self-care (OR = 2.17, P = 0.02).","['Patients with coexisting type 2 diabetes and hypertension', 'Older patients', 'patients with coexisting type 2 diabetes and hypertension', 'Female patients', '148 patients with coexisting type 2 diabetes mellitus and hypertension', 'Patients living with family or others (e.g., caregivers']",[],"['socio-demographic characteristics (sex, age, living status, perceived health status, and diabetes duration', 'Self-efficacy', 'avoid tobacco and alcohol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0557130', 'cui_str': 'Lives with family'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",[],"[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]",148.0,0.0208778,"Older patients were found to be more likely to adhere to diet therapy (OR = 2.21, P = 0.01) and self-monitoring/self-care (OR = 2.17, P = 0.02).","[{'ForeName': 'Zhenzhen', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Department of Industrial and Manufacturing Systems Engineering, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Kaifeng', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Industrial and Manufacturing Systems Engineering, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Calvin', 'Initials': 'C', 'LastName': 'Or', 'Affiliation': 'Department of Industrial and Manufacturing Systems Engineering, The University of Hong Kong, Hong Kong, China. klor@hku.hk.'}, {'ForeName': 'Jiayin', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Industrial and Manufacturing Systems Engineering, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Mian', 'Initials': 'M', 'LastName': 'Yan', 'Affiliation': 'School of Intelligent Systems Science and Engineering, Jinan University, Zhuhai, China.'}, {'ForeName': 'Hailiang', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Systems Engineering and Engineering Management, City University of Hong Kong, Hong Kong, China.'}]",BMC public health,['10.1186/s12889-020-09274-4']
2345,32787819,Correction to: Persistent physical symptoms reduction intervention: a system change and evaluation in secondary care (PRINCE secondary) - a CBT-based transdiagnostic approach: study protocol for a randomised controlled trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,[],[],[],[],[],[],,0.0793028,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK. trudie.chalder@kcl.ac.uk.""}, {'ForeName': 'Meenal', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'James', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hotopf', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Frank', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Watts', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""Health Economics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'David', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ashworth', 'Affiliation': ""Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Mujtaba', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Garrood', 'Affiliation': ""Department of Rheumatology, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Moss-Morris', 'Affiliation': ""School of Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Landau', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",BMC psychiatry,['10.1186/s12888-020-02811-w']
2346,32788532,Availability Bias Causes Misdiagnoses by Physicians: Direct Evidence from a Randomized Controlled Trial.,"Objective Empirical evidence on the availability bias associated with diagnostic errors is still insufficient. We investigated whether or not recent experience with clinical problems can lead physicians to make diagnostic errors due to availability bias and whether or not reflection counteracts this bias. Methods Forty-six internal medicine residents were randomly divided into a control group (CG) and experimental group (EG). Among the eight clinical cases used in this study, three experimental cases were similar to the disease of dengue fever (DF) but exhibited different diagnoses, one was actually DF, and the other four filler cases were not associated with DF. First, only the EG received information on DF, while the CG knew nothing about this study. Then, six hours later, all participants were asked to diagnose eight clinical cases via nonanalytic reasoning. Finally, four cases were diagnosed again via reflective reasoning. Results In stage 2, the average score of the CG in the diagnosis of experimental cases was significantly higher than that of the filler cases (0.80 vs. 0.59, p<0.01), but the EG's average score in the two types of cases was not significantly different (0.66 vs. 0.64, p=0.756 ). The EG and CG had significantly different scores for each experimental case, while no difference was observed in the filler cases. The proportion of diseases incorrectly diagnosed as DF among experimental cases ranged from 71% to 100% in the EG. There were no significant differences between the mean diagnostic accuracy scores obtained by nonanalytic reasoning and those obtained by the reflective reasoning in any cases. Conclusion Availability bias led to diagnostic errors. Misdiagnoses cannot always be repaired solely by adopting a reflective approach.",2020,There were no significant differences between the mean diagnostic accuracy scores obtained by nonanalytic reasoning and those obtained by the reflective reasoning in any cases.,['Methods Forty-six internal medicine residents'],['control group (CG) and experimental group (EG'],"['disease of dengue fever (DF', 'mean diagnostic accuracy scores']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011311', 'cui_str': 'Dengue'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",46.0,0.0193901,There were no significant differences between the mean diagnostic accuracy scores obtained by nonanalytic reasoning and those obtained by the reflective reasoning in any cases.,"[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'School of Public Health & Management Wenzhou Medical University, P.R China.'}, {'ForeName': 'Zi Yan', 'Initials': 'ZY', 'LastName': 'Cheng', 'Affiliation': 'School of Public Health & Management Wenzhou Medical University, P.R China.'}, {'ForeName': 'Gui Lin', 'Initials': 'GL', 'LastName': 'Liu', 'Affiliation': 'School of Public Health & Management Wenzhou Medical University, P.R China.'}]","Internal medicine (Tokyo, Japan)",['10.2169/internalmedicine.4664-20']
2347,32789031,Comparison of General Anesthesia (Sevoflurane) and Spinal Anesthesia (Levobupivacaine) Methods on QT Dispersion in Inguinal Hernia Operations.,"Introduction Arrhythmias are one of the most frequently seen issues during surgical operations. In this study, we investigated and compared the effects on the QT dispersion of patients when using a method of volatile inhalation mask anesthesia with sevoflurane (VIMA: Group I) and when spinal anesthesia was performed with levobupivacaine (Group II). Methods The study included 40 patients who had American Society of Anesthesiology scores of I-II (ASA I-II), were aged from 18 to 65 years, and were scheduled for inguinal hernia operations. Approval of the university ethics committee was obtained before the study began. All patients had measurements taken for non-invasive blood pressure, including systolic arterial pressure (SAP), diastolic arterial pressure (DAP), and mean arterial pressure (MAP), heart rate (HR), and oxygen saturation (SO 2 ) values. The QT intervals were measured using the 12-derivation electrocardiogram (ECG) device (Cardiofax V). Our study was performed with randomization using the closed envelope method. Results When the percentage differences of the HR values from the initial period in both groups were compared, we observed significant differences between the groups, with increases in the VIMA group at the second period as well as increases in the VIMA group at the fourth, fifth, sixth, seventh, and ninth periods but decreases in the spinal anesthesia group for these periods. There were statistically significant differences between the two groups at the third and fifth periods when the percentage differences of the QTc values from the initial period were compared. We observed increases in the spinal anesthesia group. Conclusion In our study, we suggest that the tendency toward arrhythmia may be reduced by choosing general anesthesia with sevoflurane rather than levobupivacaine in patients with cardiac complaints who are undergoing regional anesthesia and/or taking medication that affects QT intervals.",2020,There were statistically significant differences between the two groups at the third and fifth periods when the percentage differences of the QTc values from the initial period were compared.,"['40 patients who had American Society of Anesthesiology scores of I-II (ASA I-II), were aged from 18 to 65 years, and were scheduled for inguinal hernia operations', 'patients with cardiac complaints who are undergoing regional anesthesia and/or taking medication that affects QT intervals', 'Inguinal Hernia Operations']","['sevoflurane', 'levobupivacaine', 'General Anesthesia (Sevoflurane) and Spinal Anesthesia (Levobupivacaine', 'spinal anesthesia', 'volatile inhalation mask anesthesia with sevoflurane (VIMA']","['12-derivation electrocardiogram (ECG) device (Cardiofax V', 'QTc values', 'non-invasive blood pressure, including systolic arterial pressure (SAP), diastolic arterial pressure (DAP), and mean arterial pressure (MAP), heart rate (HR), and oxygen saturation (SO 2 ) values', 'HR values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0181751', 'cui_str': 'Anesthesia mask'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4301970', 'cui_str': 'Non-invasive blood pressure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]",40.0,0.0365324,There were statistically significant differences between the two groups at the third and fifth periods when the percentage differences of the QTc values from the initial period were compared.,"[{'ForeName': 'Basak', 'Initials': 'B', 'LastName': 'Pehlivan', 'Affiliation': 'Anesthesiology, Harran University, Sanliurfa, TUR.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Akçay', 'Affiliation': 'Anesthesiology and Reanimation, Ankara Numune Training and Research Hospital, Anesthesiology and Reanimation Clinic, Ankara, TUR.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Atlas', 'Affiliation': 'Anesthesiology, Harran University, Sanliurfa, TUR.'}, {'ForeName': 'Mehmet K', 'Initials': 'MK', 'LastName': 'Erol', 'Affiliation': 'Anesthesiology, Harran University, Sanliurfa, TUR.'}, {'ForeName': 'Erdogan', 'Initials': 'E', 'LastName': 'Duran', 'Affiliation': 'Anesthesiology and Reanimation, Harran University, Sanliurfa, TUR.'}, {'ForeName': 'Mahmut A', 'Initials': 'MA', 'LastName': 'Karahan', 'Affiliation': 'Anesthesiology and Critical Care, Harran University, Sanliurfa, TUR.'}, {'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Binici', 'Affiliation': 'Anesthesiology and Critical Care, Harran University, Sanliurfa, TUR.'}, {'ForeName': 'Evren', 'Initials': 'E', 'LastName': 'Büyükfırat', 'Affiliation': 'Anesthesiology and Critical Care, Harran University, Sanliurfa, TUR.'}, {'ForeName': 'Nuray', 'Initials': 'N', 'LastName': 'Altay', 'Affiliation': 'Anesthesiology and Critical Care, Harran University, Sanliurfa, TUR.'}]",Cureus,['10.7759/cureus.9079']
2348,32789117,Utility of an educational video on epinephrine prefilled syringe usage for anaphylaxis: a randomized control trial.,"Background


Anaphylaxis is a serious allergic reaction that needs early administration of intramuscular epinephrine for treatment. Currently, structured education on epinephrine prefilled syringe usage for anaphylaxis does not exist.
Objective


This study aimed to examine the effectiveness of the epinephrine prefilled syringe usage video, compared with routine teaching method.
Methods


This was a randomized controlled trial. A total of 129 medical students were assigned either to the routine teaching group or the video teaching group. The main outcome is the total number of medical students who passed (>70%) the test. The pre-, posttest, and objective structured clinical examination (OSCE) were used to evaluate the students.
Results


At the 2-week follow-up, the individual scores increased significantly after both interventions ( p  < 0.001). The percentages of medical students who passed the exam in the pre-, posttests, and OSCE were not significantly different between the groups. In the routine teaching group and video teaching group, the percentages of students who passed increased from 32.2% to 96.6% and 28.1% to 95.3%, respectively ( p  = 0.99). Using univariate logistic regression analysis, previous knowledge of anaphylaxis was a factor to pass the test (odds ratio, 5.07; 95% confidence interval, 1.93-13.31;  p  < 0.01).
Conclusion


The study demonstrated that the scores after the video education intervention were not inferior to the routine teaching group. This technique might be applied for patients in clinical practice. However, the further researches in general population are needed to confirm the efficacy of this method.",2020,"At the 2-week follow-up, the individual scores increased significantly after both interventions ( p  < 0.001).","['anaphylaxis', '129 medical students']","['educational video', 'epinephrine prefilled syringe usage video', 'routine teaching group or the video teaching group', 'epinephrine']","['individual scores', 'total number of medical students', 'objective structured clinical examination (OSCE']","[{'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",129.0,0.0745177,"At the 2-week follow-up, the individual scores increased significantly after both interventions ( p  < 0.001).","[{'ForeName': 'Araya', 'Initials': 'A', 'LastName': 'Yuenyongviwat', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Thatchai', 'Initials': 'T', 'LastName': 'Wirodwanich', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Wipa', 'Initials': 'W', 'LastName': 'Jessadapakorn', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Pasuree', 'Initials': 'P', 'LastName': 'Sangsupawanich', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.'}]",Asia Pacific allergy,['10.5415/apallergy.2020.10.e32']
2349,32789211,Effects of a Cooking Program Based on Brain-activating Rehabilitation for Elderly Residents with Dementia in a  Roken  Facility: A Randomized Controlled Trial.,"Objective


Rehabilitation for dementia is important in  Roken  Geriatric Health Service Facilities in Japan. This study evaluated the effects of a cooking program as rehabilitation for elderly residents with dementia.
Methods


We carried out a 12-week cooking program based on the five principles of brain-activating rehabilitation (BAR): fostering a pleasant atmosphere, interactive communication, establishing social roles, giving and receiving praise, and errorless learning. The program was carried out in small groups and consisted of 90-min classes once a week. Participants were 36 elderly residents with dementia (mean 85.4 ± 6.5 years) who were randomly divided into intervention (n = 18) and control (n = 18) groups. The control group participated in recreation and both groups received individual conventional rehabilitation twice a week for 30 min. The effects of intervention were evaluated using nine outcome measures.
Results


A total of 29 participants were included in the analysis (two-way analysis of variance). The attendance rate was 86.6% in the intervention group (n = 13). The Yamaguchi  Kanji  Symbol Substitution Test (executive function) showed significant interaction (F(1, 27) = 4.305, P = 0.048) between the two groups: the control group (n = 16) showed significant deterioration (pre 4.9 ± 5.6 to post 3.0 ± 4.9; P = 0.032). The dementia behavior disturbance scale also showed significant interaction (F(1, 29) = 13.298, P = 0.001): the intervention group (n = 16) showed significant improvement (pre 21.6 ± 12.2 to post 11.4 ± 11.5; P < 0.001). No significant differences were observed in the other outcome measures.
Conclusions


Our findings suggest that a cooking program based on BAR can reduce the behavioral and psychological symptoms of dementia and maintain executive function.",2017,the intervention group (n = 16) showed significant improvement (pre 21.6 ± 12.2 to post 11.4 ± 11.5; P < 0.001).,"['Roken  Geriatric Health Service Facilities in Japan', 'Participants were 36 elderly residents with dementia (mean 85.4 ± 6.5 years', 'Elderly Residents with Dementia in a  Roken  Facility', 'elderly residents with dementia', 'A total of 29 participants']","['individual conventional rehabilitation', 'Cooking Program Based on Brain-activating Rehabilitation', 'brain-activating rehabilitation (BAR): fostering a pleasant atmosphere, interactive communication, establishing social roles, giving and receiving praise, and errorless learning', 'cooking program']","['attendance rate', 'behavioral and psychological symptoms of dementia and maintain executive function', 'dementia behavior disturbance scale']","[{'cui': 'C0018753', 'cui_str': 'Health Services for Aged'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0910435', 'cui_str': 'AM 36'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0004178', 'cui_str': 'Atmosphere'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0557963', 'cui_str': 'Praising'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",29.0,0.0189147,the intervention group (n = 16) showed significant improvement (pre 21.6 ± 12.2 to post 11.4 ± 11.5; P < 0.001).,"[{'ForeName': 'Tatsuhiko', 'Initials': 'T', 'LastName': 'Murai', 'Affiliation': 'Gunma University Graduate School of Health Sciences, Maebashi, Gunma, Japan.'}, {'ForeName': 'Haruyasu', 'Initials': 'H', 'LastName': 'Yamaguchi', 'Affiliation': 'Gunma University Graduate School of Health Sciences, Maebashi, Gunma, Japan.'}]",Progress in rehabilitation medicine,['10.2490/prm.20170004']
2350,32789431,Effect of waiting time estimates on patients satisfaction in the emergency department in a tertiary care center.,"OBJECTIVES


To examine the influence of emergency department (ED) waiting time estimate provision on the satisfaction of patients.  Methods: This was a randomized controlled trial at King Abdulaziz Medical City, Riyadh, Saudi Arabia between September 2017 and May 2018. It included 18 to 70 years old Arabic-speaking acute care patients. After being divided into 2 groups, the intervention group alone was provided waiting time estimates. Both groups answered 2 questionnaires evaluating their satisfaction and illness perception before and after seeing a doctor. Results: One-hundred patients were included. No significant difference found in waiting time satisfaction scores between groups (intervention (5.92/10±3.13), control (5.45/10±3.38), p=0.476). Demographics and illness perception had an insignificant impact on satisfaction. Waiting time estimate was preferred by most participants (70%). Conclusion: Providing waiting time estimation did not affect satisfaction but was preferred to have in the ED by most.",2020,"No significant difference found in waiting time satisfaction scores between groups (intervention (5.92/10±3.13), control (5.45/10±3.38), p=0.476).","['patients satisfaction in the emergency department in a tertiary care center', 'King Abdulaziz Medical City, Riyadh, Saudi Arabia between September 2017 and May 2018', 'One-hundred patients were included', 'patients', 'It included 18 to 70 years old Arabic-speaking acute care patients']",['emergency department (ED) waiting time estimate provision'],"['waiting time satisfaction scores', 'satisfaction and illness perception', 'Waiting time estimate', 'satisfaction']","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0574175', 'cui_str': 'Arabic language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",100.0,0.0596055,"No significant difference found in waiting time satisfaction scores between groups (intervention (5.92/10±3.13), control (5.45/10±3.38), p=0.476).","[{'ForeName': 'Khaled N', 'Initials': 'KN', 'LastName': 'Alrajhi', 'Affiliation': 'Department of Emergency Medicine, Ministry of National Guard - Health Affairs, Riyadh, Kingdom of Saudi Arabia. E-mail. Rajhik@ngha.med.sa.'}, {'ForeName': 'Nawfal A', 'Initials': 'NA', 'LastName': 'Aljerian', 'Affiliation': ''}, {'ForeName': 'Rand N', 'Initials': 'RN', 'LastName': 'Alazaz', 'Affiliation': ''}, {'ForeName': 'Lama B', 'Initials': 'LB', 'LastName': 'Araier', 'Affiliation': ''}, {'ForeName': 'Lujane S', 'Initials': 'LS', 'LastName': 'Alqahtani', 'Affiliation': ''}, {'ForeName': 'Shaden O', 'Initials': 'SO', 'LastName': 'Almushawwah', 'Affiliation': ''}]",Saudi medical journal,['10.15537/smj.2020.8.25190']
2351,32789480,Effect of Adjuvant Paclitaxel and Carboplatin on Survival in Women With Triple-Negative Breast Cancer: A Phase 3 Randomized Clinical Trial.,"Importance


The value of platinum-based adjuvant chemotherapy in patients with triple-negative breast cancer (TNBC) remains controversial, as does whether BRCA1 and BRCA2 (BRCA1/2) germline variants are associated with platinum treatment sensitivity.
Objective


To compare 6 cycles of paclitaxel plus carboplatin (PCb) with a standard-dose regimen of 3 cycles of cyclophosphamide, epirubicin, and fluorouracil followed by 3 cycles of docetaxel (CEF-T).
Design, Setting, and Participants


This phase 3 randomized clinical trial was conducted at 9 cancer centers and hospitals in China. Between July 1, 2011, and April 30, 2016, women aged 18 to 70 years with operable TNBC after definitive surgery (having pathologically confirmed regional node-positive disease or node-negative disease with tumor diameter >10 mm) were screened and enrolled. Exclusion criteria included having metastatic or locally advanced disease, having non-TNBC, or receiving preoperative anticancer therapy. Data were analyzed from December 1, 2019, to January 31, 2020, from the intent-to-treat population as prespecified in the protocol.
Interventions


Participants were randomized to receive PCb (paclitaxel 80 mg/m2 and carboplatin [area under the curve = 2] on days 1, 8, and 15 every 28 days for 6 cycles) or CEF-T (cyclophosphamide 500 mg/m2, epirubicin 100 mg/m2, and fluorouracil 500 mg/m2 every 3 weeks for 3 cycles followed by docetaxel 100 mg/m2 every 3 weeks for 3 cycles).
Main Outcomes and Measures


The primary end point was disease-free survival (DFS). Secondary end points included overall survival, distant DFS, relapse-free survival, DFS in patients with germline variants in BRCA1/2 or homologous recombination repair (HRR)-related genes, and toxicity.
Results


A total of 647 patients (mean [SD] age, 51 [44-57] years) with operable TNBC were randomized to receive CEF-T (n = 322) or PCb (n = 325). At a median follow-up of 62 months, DFS time was longer in those assigned to PCb compared with CEF-T (5-year DFS, 86.5% vs 80.3%, hazard ratio [HR] = 0.65; 95% CI, 0.44-0.96; P = .03). Similar outcomes were observed for distant DFS and relapse-free survival. There was no statistically significant difference in overall survival between the groups (HR = 0.71; 95% CI, 0.42-1.22, P = .22). In the exploratory and hypothesis-generating subgroup analyses of PCb vs CEF-T, the HR for DFS was 0.44 (95% CI, 0.15-1.31; P = .14) in patients with the BRCA1/2 variant and 0.39 (95% CI, 0.15-0.99; P = .04) in those with the HRR variant. Safety data were consistent with the known safety profiles of relevant drugs.
Conclusions and Relevance


These findings suggest that a paclitaxel-plus-carboplatin regimen is an effective alternative adjuvant chemotherapy choice for patients with operable TNBC. In the era of molecular classification, subsets of TNBC sensitive to PCb should be further investigated.
Trial Registration


ClinicalTrials.gov Identifier: NCT01216111.",2020,"At a median follow-up of 62 months, DFS time was longer in those assigned to PCb compared with CEF-T (5-year DFS, 86.5% vs 80.3%, hazard ratio [HR] = 0.65; 95% CI, 0.44-0.96; P = .03).","['patients with triple-negative breast cancer (TNBC', '647 patients (mean [SD] age, 51 [44-57] years) with operable TNBC', '9 cancer centers and hospitals in China', 'Between July 1, 2011, and April 30, 2016, women aged 18 to 70 years with operable TNBC after definitive surgery (having pathologically confirmed regional node-positive disease or node-negative disease with tumor diameter >10 mm) were screened and enrolled', 'patients with operable TNBC', 'Exclusion criteria included having metastatic or locally advanced disease, having non-TNBC, or receiving preoperative anticancer therapy', 'Women With Triple-Negative Breast Cancer']","['docetaxel', 'CEF-T', 'paclitaxel-plus-carboplatin regimen', 'PCb', 'platinum-based adjuvant chemotherapy', 'CEF-T (cyclophosphamide 500 mg/m2, epirubicin 100 mg/m2, and fluorouracil', 'PCb (paclitaxel 80 mg/m2 and carboplatin', 'Adjuvant Paclitaxel and Carboplatin', 'paclitaxel plus carboplatin (PCb', 'cyclophosphamide, epirubicin, and fluorouracil followed by 3 cycles of docetaxel (CEF-T']","['overall survival, distant DFS, relapse-free survival, DFS in patients with germline variants in BRCA1/2 or homologous recombination repair (HRR)-related genes, and toxicity', 'DFS time', 'overall survival', 'Survival', 'distant DFS and relapse-free survival', 'disease-free survival (DFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C4080545', 'cui_str': 'Cyclophosphamide 500 MG'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C1158513', 'cui_str': 'Recombinational Repair of DNA'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",647.0,0.405234,"At a median follow-up of 62 months, DFS time was longer in those assigned to PCb compared with CEF-T (5-year DFS, 86.5% vs 80.3%, hazard ratio [HR] = 0.65; 95% CI, 0.44-0.96; P = .03).","[{'ForeName': 'Ke-Da', 'Initials': 'KD', 'LastName': 'Yu', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Fu-Gui', 'Initials': 'FG', 'LastName': 'Ye', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'He', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Mo', 'Affiliation': 'Department of Cancer Prevention & Clinical Statistics Center, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jiong', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Guang-Yu', 'Initials': 'GY', 'LastName': 'Liu', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Gen-Hong', 'Initials': 'GH', 'LastName': 'Di', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Xiao-Hua', 'Initials': 'XH', 'LastName': 'Zeng', 'Affiliation': 'Breast Center, Chongqing Cancer Hospital, Chongqing University, Chongqing, China.'}, {'ForeName': 'Ping-Qing', 'Initials': 'PQ', 'LastName': 'He', 'Affiliation': ""Department of Breast Surgery, Shanghai Sixth People's Hospital, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Ke-Jin', 'Initials': 'KJ', 'LastName': 'Wu', 'Affiliation': 'Department of Breast Surgery, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Yi-Feng', 'Initials': 'YF', 'LastName': 'Hou', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Breast Surgery, The International Peace Maternity & Child Health Hospital of China Welfare Institute, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""Department of Breast Surgery, Shanghai Ninth People's Hospital Huangpu Branch, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Zhi-Gang', 'Initials': 'ZG', 'LastName': 'Zhuang', 'Affiliation': 'Department of Breast Surgery, Shanghai First Maternity and Infant Hospital, Shanghai Tongji University, Shanghai, China.'}, {'ForeName': 'Chuan-Gui', 'Initials': 'CG', 'LastName': 'Song', 'Affiliation': 'Department of Breast Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Lin', 'Affiliation': 'Department of Breast Surgery, Tongji University School of Medicine Yangpu Hospital, Shanghai, China.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Toss', 'Affiliation': 'Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Ricci', 'Affiliation': 'Department of Drug Development and Innovation, Institute Curie, Paris & Saint-Cloud, France.'}, {'ForeName': 'Zhen-Zhou', 'Initials': 'ZZ', 'LastName': 'Shen', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Zhi-Ming', 'Initials': 'ZM', 'LastName': 'Shao', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}]",JAMA oncology,['10.1001/jamaoncol.2020.2965']
2352,32789503,Hippocampal Avoidance Whole-brain Radiotherapy without Memantine in Preserving Neurocognitive Function for Brain Metastases: A Phase II Blinded Randomized Trial.,"BACKGROUND


Hippocampal avoidance whole-brain radiotherapy (HA-WBRT) shows potential for neurocognitive preservation. This study aimed to evaluate whether HA-WBRT or conformal WBRT (C-WBRT) is better for preserving neurocognitive function.
METHODS


This single-blinded randomized phase II trial enrolled patients with brain metastases and randomly assigned to receive HA-WBRT or C-WBRT. Primary end point is the decline of Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recall at 4 months after treatment. Neurocognitive function tests were analyzed with a mixed effect model. Brain progression free survival (BPFS) and overall survival (OS) were estimated using the Kaplan-Meier method.
RESULTS


From March 2015 to December 2018, seventy patients were randomized to yield a total cohort of 65 evaluable patients (33 in the HA-WBRT arm and 32 in the C-WBRT arm) with a median follow-up of 12.4 months.　No differences in baseline neurocognitive function existed between the two arms. The mean change of HVLT-R delayed recall at 4 months was -8.8% in the HA-WBRT arm, and +3.8% in the C-WBRT arm (p=0.31). At six months, patients receiving HA-WBRT showed favorable perpetuation of HVLT-R total recall (mean difference = 2.60, p=0.079) and significantly better preservation of the HVLT-R recognition-discrimination index (mean difference = 1.78, p=0.019) and memory score (mean difference = 4.38, p=0.020) compared with patients undergoing C-WBRT. There were no differences in TMT part A, part B, or the COWA test between the two arms at any time point. There were no differences in BPFS or OS between arms as well.
CONCLUSIONS


Patients receiving HA-WBRT without memantine showed better preservation in memory at 6-month follow-up, but not in verbal fluency or executive function.",2020,"There were no differences in TMT part A, part B, or the COWA test between the two arms at any time point.","['enrolled patients with brain metastases', 'From March 2015 to December 2018, seventy patients were randomized to yield a total cohort of 65 evaluable patients (33 in the HA-WBRT arm and 32 in the C-WBRT arm) with a median follow-up of 12.4 months', 'Brain Metastases']","['HA-WBRT or C-WBRT', 'Hippocampal avoidance whole-brain radiotherapy (HA-WBRT', 'memantine', 'Hippocampal Avoidance Whole-brain Radiotherapy without Memantine', 'HA-WBRT or conformal WBRT (C-WBRT']","['Brain progression free survival (BPFS) and overall survival (OS', 'Neurocognitive function tests', 'memory score', 'HVLT-R recognition-discrimination index', 'verbal fluency or executive function', 'decline of Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recall', 'favorable perpetuation of HVLT-R total recall', 'TMT part A, part B, or the COWA test', 'BPFS or OS', 'baseline neurocognitive function', 'mean change of HVLT-R delayed recall']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C1520143', 'cui_str': 'Whole brain radiation therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0026377', 'cui_str': 'Molecular conformation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517543', 'cui_str': '12.4'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C1520143', 'cui_str': 'Whole brain radiation therapy'}, {'cui': 'C0026377', 'cui_str': 'Molecular conformation'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C3827022', 'cui_str': 'Controlled Oral Word Association Test'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",70.0,0.171341,"There were no differences in TMT part A, part B, or the COWA test between the two arms at any time point.","[{'ForeName': 'Wen-Chi', 'Initials': 'WC', 'LastName': 'Yang', 'Affiliation': 'Division of Radiation Oncology, Departments of Oncology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ya-Fang', 'Initials': 'YF', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Imaging, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chi-Cheng', 'Initials': 'CC', 'LastName': 'Yang', 'Affiliation': 'Department of Psychology, National Chengchi University, Taipei, Taiwan.'}, {'ForeName': 'Pei-Fang', 'Initials': 'PF', 'LastName': 'Wu', 'Affiliation': 'Division of Radiation Oncology, Departments of Oncology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hsing-Min', 'Initials': 'HM', 'LastName': 'Chan', 'Affiliation': 'Division of Radiation Oncology, Departments of Oncology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Jenny Ling-Yu', 'Initials': 'JL', 'LastName': 'Chen', 'Affiliation': 'Division of Radiation Oncology, Departments of Oncology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Guann-Yiing', 'Initials': 'GY', 'LastName': 'Chen', 'Affiliation': 'Division of Radiation Oncology, Departments of Oncology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Jason Chia-Hsien', 'Initials': 'JC', 'LastName': 'Cheng', 'Affiliation': 'Division of Radiation Oncology, Departments of Oncology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Sung-Hsin', 'Initials': 'SH', 'LastName': 'Kuo', 'Affiliation': 'Division of Radiation Oncology, Departments of Oncology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Feng-Ming', 'Initials': 'FM', 'LastName': 'Hsu', 'Affiliation': 'Division of Radiation Oncology, Departments of Oncology, National Taiwan University Hospital, Taipei, Taiwan.'}]",Neuro-oncology,['10.1093/neuonc/noaa193']
2353,32789505,Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes: Interim Analysis of 2 Randomized Clinical Trials.,"Importance


A vaccine against coronavirus disease 2019 (COVID-19) is urgently needed.
Objective


To evaluate the safety and immunogenicity of an investigational inactivated whole-virus COVID-19 vaccine in China.
Interventions


In the phase 1 trial, 96 participants were assigned to 1 of the 3 dose groups (2.5, 5, and 10 μg/dose) and an aluminum hydroxide (alum) adjuvant-only group (n = 24 in each group), and received 3 intramuscular injections at days 0, 28, and 56. In the phase 2 trial, 224 adults were randomized to 5 μg/dose in 2 schedule groups (injections on days 0 and 14 [n = 84] vs alum only [n = 28], and days 0 and 21 [n = 84] vs alum only [n = 28]).
Design, Setting, and Participants


Interim analysis of ongoing randomized, double-blind, placebo-controlled, phase 1 and 2 clinical trials to assess an inactivated COVID-19 vaccine. The trials were conducted in Henan Province, China, among 96 (phase 1) and 224 (phase 2) healthy adults aged between 18 and 59 years. Study enrollment began on April 12, 2020. The interim analysis was conducted on June 16, 2020, and updated on July 27, 2020.
Main Outcomes and Measures


The primary safety outcome was the combined adverse reactions 7 days after each injection, and the primary immunogenicity outcome was neutralizing antibody response 14 days after the whole-course vaccination, which was measured by a 50% plaque reduction neutralization test against live severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Results


Among 320 patients who were randomized (mean age, 42.8 years; 200 women [62.5%]), all completed the trial up to 28 days after the whole-course vaccination. The 7-day adverse reactions occurred in 3 (12.5%), 5 (20.8%), 4 (16.7%), and 6 (25.0%) patients in the alum only, low-dose, medium-dose, and high-dose groups, respectively, in the phase 1 trial; and in 5 (6.0%) and 4 (14.3%) patients who received injections on days 0 and 14 for vaccine and alum only, and 16 (19.0%) and 5 (17.9%) patients who received injections on days 0 and 21 for vaccine and alum only, respectively, in the phase 2 trial. The most common adverse reaction was injection site pain, followed by fever, which were mild and self-limiting; no serious adverse reactions were noted. The geometric mean titers of neutralizing antibodies in the low-, medium-, and high-dose groups at day 14 after 3 injections were 316 (95% CI, 218-457), 206 (95% CI, 123-343), and 297 (95% CI, 208-424), respectively, in the phase 1 trial, and were 121 (95% CI, 95-154) and 247 (95% CI, 176-345) at day 14 after 2 injections in participants receiving vaccine on days 0 and 14 and on days 0 and 21, respectively, in the phase 2 trial. There were no detectable antibody responses in all alum-only groups.
Conclusions and Relevance


In this interim report of the phase 1 and phase 2 trials of an inactivated COVID-19 vaccine, patients had a low rate of adverse reactions and demonstrated immunogenicity; the study is ongoing. Efficacy and longer-term adverse event assessment will require phase 3 trials.
Trial Registration


Chinese Clinical Trial Registry Identifier: ChiCTR2000031809.",2020,"The most common adverse reaction was injection site pain, followed by fever, which were mild and self-limiting; no serious adverse reactions were noted.","['China', '96 participants', '224 adults', 'Henan Province, China, among 96 (phase 1) and 224 (phase 2) healthy adults aged between 18 and 59 years', '320 patients who were randomized (mean age, 42.8 years; 200 women [62.5']","['aluminum hydroxide (alum) adjuvant-only group', 'investigational inactivated whole-virus COVID-19 vaccine', 'Inactivated Vaccine Against SARS-CoV-2', 'placebo']","['serious adverse reactions', 'antibody responses', 'geometric mean titers of neutralizing antibodies', 'Safety and Immunogenicity Outcomes', 'safety and immunogenicity', 'plaque reduction neutralization test against live severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2', '7-day adverse reactions', 'neutralizing antibody response']","[{'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517836', 'cui_str': '62.5'}]","[{'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042212', 'cui_str': 'Vaccines, Killed'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0027944', 'cui_str': 'Neutralization Tests'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",224.0,0.329137,"The most common adverse reaction was injection site pain, followed by fever, which were mild and self-limiting; no serious adverse reactions were noted.","[{'ForeName': 'Shengli', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Duan', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Yuntao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Dongyang', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Huajun', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Xinguo', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Peng', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Yanbo', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Biostatistics, Ministry of Education Key Laboratory of Environment and Health and State Key Laboratory of Environmental Health (Incubation), School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Yunkai', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Xiaoxiao', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Wangyang', 'Initials': 'W', 'LastName': 'You', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Xuewei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Zejun', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Zhengli', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Yanxia', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Xuqin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Lianghao', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Yongli', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Public Health, Zhengzhou University, Zhengzhou, Henan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Wenhui', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Shihe', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Jianhui', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Ziyan', 'Initials': 'Z', 'LastName': 'Meng', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Pan', 'Affiliation': 'Department of Epidemiology and Biostatistics, Ministry of Education Key Laboratory of Environment and Health and State Key Laboratory of Environmental Health (Incubation), School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Zhiming', 'Initials': 'Z', 'LastName': 'Yuan', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Shen', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Wanshen', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}]",JAMA,['10.1001/jama.2020.15543']
2354,32789678,Multi-proteomic approach to predict specific cardiovascular events in patients with diabetes and myocardial infarction: findings from the EXAMINE trial.,"BACKGROUND


Patients with diabetes who had a recent myocardial infarction (MI) are at high risk of cardiovascular events. Therefore, risk assessment is important for treatment and shared decisions. We used data from EXAMINE trial to investigate whether a multi-proteomic approach would provide specific proteomic signatures and also improve the prognostic capacity for determining the risk of cardiovascular death, MI, stroke, heart failure [HF], all-cause death, and combinations of these outcomes.
METHODS


93 circulating proteins (92 from the Olink® CVDII plus troponin) were assessed in 5131 patients. Cox, competing risks, and reclassification measures were applied.
RESULTS


The clinical model showed good discrimination and calibration for all outcomes. On top of the clinical model that included age, sex, smoking, diabetes duration, history of MI (prior to the index MI of inclusion), history of HF hospitalization, history of stroke, atrial fibrillation, hypertension, systolic blood pressure, statin therapy, estimated glomerular filtration rate, and study treatment (alogliptin or placebo), troponin and BNP added prognostic information to the composite of cardiovascular death, MI, or stroke (∆C-index + 5%) and cardiovascular death alone (∆C-index + 7%). Troponin, BNP, and TRAILR2 added prognostic information on all-cause death and the composite of cardiovascular death or HF hospitalization. HF hospitalization alone was improved by adding BNP and Gal-9. For MI, troponin, FGF23, and AMBP added prognostic value; whereas for stroke, only troponin added prognostic value (multi-proteomics improved C-index > 3% [p < 0.001] for all the studied outcomes). The addition of the final biomarker selection to the clinical model improved event reclassification (cNRI from + 23% to + 64%). Specifically, the addition of the biomarkers allowed a better classification of patients at low risk (as having ""true"" low risk) and patients and high risk (as having ""true"" high risk). These results were consistent for all the studied outcomes with even more marked differences in the fatal events.
CONCLUSIONS


The addition of multi-proteomic biomarkers to a clinical model in this population with diabetes and a recent MI allowed a better risk prediction and event reclassification, potentially helping for better risk assessment and targeted treatment decisions. T2D type 2 diabetes, MI myocardial infarction, CV cardiovascular, HFH heart failure hospitalization, Δ delta, cNRI continuous net reclassification index, BNP brain natriuretic peptide, TRAILR2 trail receptor 2 (or death receptor 5), Gal-9 galectin-9, FGF23 fibroblast growth factor 23.",2020,"Troponin, BNP, and TRAILR2 added prognostic information on all-cause death and the composite of cardiovascular death or HF hospitalization.","['patients with diabetes and myocardial infarction', 'Patients with diabetes who had a recent myocardial infarction (MI', '93 circulating proteins (92 from the Olink® CVDII plus troponin) were assessed in 5131 patients', 'included age, sex, smoking, diabetes duration, history of MI (prior to the index MI of inclusion), history of HF hospitalization, history of stroke, atrial fibrillation, hypertension, systolic blood pressure, statin therapy, estimated glomerular filtration rate, and study treatment (alogliptin or placebo), troponin and BNP added prognostic information to the composite of cardiovascular death, MI, or stroke (∆C-index\u2009+\u20095%) and cardiovascular death alone (∆C-index\u2009+\u20097']",['Multi-proteomic approach'],"['HF hospitalization alone', 'fatal events', 'T2D type 2 diabetes, MI myocardial infarction, CV cardiovascular, HFH heart failure hospitalization, Δ delta, cNRI continuous net reclassification index, BNP brain natriuretic peptide, TRAILR2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1998297', 'cui_str': 'Recent myocardial infarction'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1275835', 'cui_str': 'History of myocardial infarction'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1958126', 'cui_str': 'alogliptin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0872252', 'cui_str': 'Proteomics'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C1527752', 'cui_str': 'TNFRSF10B protein, human'}]",5131.0,0.0369234,"Troponin, BNP, and TRAILR2 added prognostic information on all-cause death and the composite of cardiovascular death or HF hospitalization.","[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Université de Lorraine, Centre D'Investigation Clinique- Plurithématique Inserm CIC-P 1433, Inserm U1116, CHRU Nancy Hopitaux de Brabois, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France. j.ferreira@chru-nancy.fr.""}, {'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Division of Cardiology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Mehta', 'Affiliation': 'Cytel Corporation, Cambridge, MA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Bakris', 'Affiliation': 'Department of Medicine, American Heart Association Comprehensive Hypertension Center, University of Chicago, Chicago, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': ""Université de Lorraine, Centre D'Investigation Clinique- Plurithématique Inserm CIC-P 1433, Inserm U1116, CHRU Nancy Hopitaux de Brabois, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.""}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'White', 'Affiliation': 'Calhoun Cardiology Center, University of Connecticut School of Medicine, Farmington, Connecticut, USA.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Université de Lorraine, Centre D'Investigation Clinique- Plurithématique Inserm CIC-P 1433, Inserm U1116, CHRU Nancy Hopitaux de Brabois, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.""}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-020-01729-3']
2355,32789685,[Placebo - the power of expectation].,,2020,,[],['Placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.203355,,"[{'ForeName': 'U', 'Initials': 'U', 'LastName': 'Bingel', 'Affiliation': 'Klinik für Neurologie, Universitätsklinikum Essen, Hufelandstraße\xa055, 45147, Essen, Deutschland. Ulrike.Bingel@uk-essen.de.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kersting', 'Affiliation': 'Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinikum Leipzig, Leipzig, Deutschland.'}]",Der Nervenarzt,['10.1007/s00115-020-00965-2']
2356,32789709,Comparison of nasal functional outcomes of let down rhinoplasty and open technical rhinoplasty using spreader graft.,"PURPOSE


This study aimed to compare open technique rhinoplasty with spreader graft and Let Down rhinoplasty using Nasal Symptom Obstruction Evaluation (NOSE), Sinonasal Outcome Test-22 (SNOT-22), and Visual Analog Scale (VAS).
MATERIALS AND METHODS


A total of 50 patients were included in the study. Patients with a hump greater than 4 mm and mild septal deviation participated in the study. The patients were divided into two groups. Group 1 consisted of 26 patients who underwent Let Down rhinoplasty, while Group 2 consisted of 24 patients who underwent open rhinoplasty with spreader graft. NOSE, SNOT-22, and VAS scales were completed by both groups preoperatively and postoperatively.
RESULTS


There was no significant difference between the groups in terms of age and gender. Postoperative values of scales were significantly lower than preoperative values in Group 1 (p < 0.001). In Group 2, postoperative values were significantly lower than preoperative values (p < 0.001). There was no significant difference between the two groups according to NOSE, SNOT-22 and VAS scores.
CONCLUSION


According to the comparison of scale scores, both Let Down rhinoplasty and open technique rhinoplasty using spreader graft improved nasal functional results such as nasal obstruction.",2020,"According to the comparison of scale scores, both Let Down rhinoplasty and open technique rhinoplasty using spreader graft improved nasal functional results such as nasal obstruction.","['Patients with a hump greater than 4\xa0mm and mild septal deviation participated in the study', 'A total of 50 patients were included in the study', '26 patients who underwent']","['open rhinoplasty with spreader graft', 'Let Down rhinoplasty', 'let down rhinoplasty and open technical rhinoplasty using spreader graft']","['NOSE, SNOT-22, and VAS scales', 'NOSE, SNOT-22 and VAS scores', 'postoperative values', 'Nasal Symptom Obstruction Evaluation (NOSE), Sinonasal Outcome Test-22 (SNOT-22), and Visual Analog Scale (VAS', 'Postoperative values of scales']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0549397', 'cui_str': 'Deviated nasal septum'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0396086', 'cui_str': 'Open rhinoplasty'}, {'cui': 'C0183479', 'cui_str': 'Spreader'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0086562', 'cui_str': 'Energy Transfer, Linear'}, {'cui': 'C0035467', 'cui_str': 'Rhinoplasty'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0449851', 'cui_str': 'Technique'}]","[{'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",50.0,0.0200533,"According to the comparison of scale scores, both Let Down rhinoplasty and open technique rhinoplasty using spreader graft improved nasal functional results such as nasal obstruction.","[{'ForeName': 'Burak Mustafa', 'Initials': 'BM', 'LastName': 'Taş', 'Affiliation': 'Kırıkkale Yüksek Ihtisas Hospital Otorhinolaryngology Clinic, Kırıkkale, Turkey. mbtass@hotmail.com.'}, {'ForeName': 'Burak', 'Initials': 'B', 'LastName': 'Erden', 'Affiliation': 'Mersin Province Training and Research Hospital Otorhinolaryngology Clinic, Mersin, Turkey.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06270-7']
2357,32789723,Comparison of different types of covered self-expandable metal stents for malignant colorectal obstruction.,"BACKGROUND


Stent migration is one of the main drawbacks of covered self-expandable metal stent (SEMSs), occurring in up to 40% of malignant colorectal obstruction management cases. Various types of covered SEMSs have been developed to reduce this risk. We aimed to compare the effectiveness and complication rates of the flare-type covered SEMS (Flare) with those of the double-layered covered SEMS (ComVi).
METHODS


We performed a prospective, randomized study in four tertiary referral centers between July 2016 and April 2018. Patients with malignant colorectal obstruction were eligible for the study. The primary outcome was migration rate as observed within the first month. Rates of technical success, clinical success, and complications within the first month were also assessed.
RESULTS


A total of 60 patients were included (mean age, 70.5 ± 12.5 years; male, 31 [51.7%]). Flare and ComVi stents were applied in 30 patients each. The Flare and ComVi groups showed comparable technical success rates (90% [27/30] vs. 96.7% [29/30], p = 0.605) and clinical success rates (85.2% [23/27] vs. 75.9% [22/29], p = 0.589). Migration occurred in three (11.1%) and four (13.8%) cases in the Flare and ComVi groups, respectively, without significant difference (p = 0.99), and the risk of other complications, including perforation and re-obstruction, did not differ between the two groups.
CONCLUSIONS


Our study indicates that both flare-shape and double-layered covered SEMSs are equally effective options for the management of malignant colorectal obstruction with low migration rates when compared with previously reported migration risk of covered SEMS.",2020,"Migration occurred in three (11.1%) and four (13.8%) cases in the Flare and ComVi groups, respectively, without significant difference (p = 0.99), and the risk of other complications, including perforation and re-obstruction, did not differ between the two groups.
","['Patients with malignant colorectal obstruction were eligible for the study', 'A total of 60 patients were included (mean age, 70.5\u2009±\u200912.5\xa0years; male, 31 [51.7', 'malignant colorectal obstruction', 'four tertiary referral centers between July 2016 and April 2018']","['covered self-expandable metal stents', 'flare-type covered SEMS (Flare) with those of the double-layered covered SEMS (ComVi']","['Migration', 'risk of other complications, including perforation and re-obstruction', 'effectiveness and complication rates', 'Rates of technical success, clinical success, and complications', 'clinical success rates', 'technical success rates', 'migration rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C4042807', 'cui_str': 'Self Expandable Metallic Stent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",60.0,0.176818,"Migration occurred in three (11.1%) and four (13.8%) cases in the Flare and ComVi groups, respectively, without significant difference (p = 0.99), and the risk of other complications, including perforation and re-obstruction, did not differ between the two groups.
","[{'ForeName': 'Joon Seop', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Kyungpook National University School of Medicine, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Hyun Seok', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Kyungpook National University School of Medicine, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Eun Soo', 'Initials': 'ES', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Kyungpook National University School of Medicine, Kyungpook National University Hospital, Daegu, South Korea. dandy813@hanmail.net.'}, {'ForeName': 'Min Kyu', 'Initials': 'MK', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine, Kyungpook National University School of Medicine, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Jin Tae', 'Initials': 'JT', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Ho Gak', 'Initials': 'HG', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Dong Wook', 'Initials': 'DW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Dae Jin', 'Initials': 'DJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Fatima Hospital of Daegu, Daegu, South Korea.'}, {'ForeName': 'Yoo Jin', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Keimyung University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Chang Heon', 'Initials': 'CH', 'LastName': 'Yang', 'Affiliation': 'Department of Internal Medicine, Dongguk University School of Medicine, Gyeongju, South Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Surgical endoscopy,['10.1007/s00464-020-07869-x']
2358,32789748,The Effect of Prechemotherapy Education Using Audio Visual Methods on the Distress of Patients with Cancer.,"Chemotherapy is a commonly used cancer treatment. However, it causes physical side effects and psychological side effects such as distress. Providing prechemotherapy education using audiovisual methods can reduce distress, but not all research about the use of educational videos have the same conclusions. This study aimed to evaluate the effect of prechemotherapy education using audio visual methods on distress of patients with cancer. This study was a quasi-experiment using pre-test and posttest design with a control group. Eighty-two cancer patients who undergo chemotherapy for the first time were divided into 2 groups with forty-one patients in the control group and forty-one patients in the intervention group. Patients in the control group received education with a booklet (usual care), while the intervention group received prechemotherapy education using audio visual materials. Patients completed a distress thermometer before and 1-2 weeks after chemotherapy. The analysis used the Wilcoxon test in each group before and 1-2 weeks after prechemotherapy education. The Mann-Whitney tests were used to determine the difference in distress scores between the two groups. Statistical significance was defined as p value < 0.05. The effect of prechemotherapy education in each group was in the control group (p = 0.004) and the intervention group (p = 0.000). The control group had a mean decrease of 1.69 points, and the intervention group had a mean decrease of 1.29 points. There was a significant difference of distress between control group and intervention group with a p value of 0.037. The conclusion is the prechemotherapy education using audio visual method can reduce distress in patients with cancer in addition to the usual method.",2020,The effect of prechemotherapy education in each group was in the control group (p = 0.004) and the intervention group (p = 0.000).,"['Patients with Cancer', 'Eighty-two cancer patients who undergo chemotherapy for the first time', 'patients with cancer']","['Prechemotherapy Education Using Audio Visual Methods', 'prechemotherapy education using audio visual methods', 'Chemotherapy', 'education with a booklet (usual care), while the intervention group received prechemotherapy education using audio visual materials']","['distress scores', 'distress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",82.0,0.030928,The effect of prechemotherapy education in each group was in the control group (p = 0.004) and the intervention group (p = 0.000).,"[{'ForeName': 'Alfonsius Ade', 'Initials': 'AA', 'LastName': 'Wirawan', 'Affiliation': 'Magister of Nursing, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Susanna Hilda', 'Initials': 'SH', 'LastName': 'Hutajulu', 'Affiliation': 'Division of Hematology and Medical Oncology, Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada/Dr Sardjito General Hospital, Yogyakarta, Indonesia.'}, {'ForeName': 'Haryani', 'Initials': 'H', 'LastName': 'Haryani', 'Affiliation': 'Department of Medical Surgical Nursing, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Jl. Farmako, Senolowo, Sinduadi, Kec. Mlati, Kabupaten Sleman, Daerah Istimewa, Yogyakarta, 55281, Indonesia. Haryani@ugm.ac.id.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-020-01830-1']
2359,32789929,Intervention effects on professionals' attitudes towards the participation of adults with visual and severe or profound intellectual disabilities.,"BACKGROUND


We investigated the effects of the ""Care for Participation+"" (CFP+) intervention on direct support professionals' (DSPs') attitudes regarding the participation of adults with visual and severe or profound intellectual disabilities (VSPID).
METHODS


We implemented a pilot non-randomized controlled trial with two control groups to compare DSPs' attitudes towards CFP+ using the Attitudes towards Participation Questionnaire (APQ) and DSPs' written profiles of adults with VSPID.
RESULTS


CPP+ and the Participation Mind Map control group showed a positive trend for the ""leisure/recreation,"" ""social relations,"" and ""ability to act"" APQ domains compared to the usual care control group. The CFP+ group described significantly fewer disabilities at 6 months, reflecting a more positive attitude than controls.
CONCLUSION


CFP+ had positive effects on DSPs' attitudes towards the participation of adults with VSPID. The small sample size, ceiling effects, measurement instruments used, and implementation difficulties may have hampered understanding the full potential of CFP+.",2020,"RESULTS


CPP+ and the Participation Mind Map control group showed a positive trend for the ""leisure/recreation,"" ""social relations,"" and ""ability to act"" APQ domains compared to the usual care control group.","['adults with visual and severe or profound intellectual disabilities', 'adults with visual and severe or profound intellectual disabilities (VSPID', 'adults with VSPID']","['Care for Participation+"" (CFP+) intervention', 'CFP']","[""DSPs' attitudes"", 'leisure/recreation,"" ""social relations,"" and ""ability to act"" APQ domains', 'disabilities']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020796', 'cui_str': 'Profound intellectual disability'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0055162', 'cui_str': 'CFP protocol'}]","[{'cui': 'C0058758', 'cui_str': 'Drostanolone propionate'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",,0.0701028,"RESULTS


CPP+ and the Participation Mind Map control group showed a positive trend for the ""leisure/recreation,"" ""social relations,"" and ""ability to act"" APQ domains compared to the usual care control group.","[{'ForeName': 'Gineke', 'Initials': 'G', 'LastName': 'Hanzen', 'Affiliation': 'Royal Dutch Visio - de Brink, Vries, The Netherlands.'}, {'ForeName': 'Aly', 'Initials': 'A', 'LastName': 'Waninge', 'Affiliation': 'Royal Dutch Visio - de Brink, Vries, The Netherlands.'}, {'ForeName': 'Ruth M A', 'Initials': 'RMA', 'LastName': 'van Nispen', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Public Health research institute, Boelelaan 1117, Ophtalmology, Amsterdam, The Netherlands.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Vlaskamp', 'Affiliation': 'Faculty of Behavioural and Social Sciences, Department of Pedagogy and Educational Sciences, unit of special needs education and youth care, University of Groningen, Grote Rozenstraat 38, Groningen, The Netherlands.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Post', 'Affiliation': 'Faculty of Behavioural and Social Sciences, Department of Pedagogy and Educational Sciences, unit of special needs education and youth care, University of Groningen, Grote Rozenstraat 38, Groningen, The Netherlands.'}, {'ForeName': 'Annette A J', 'Initials': 'AAJ', 'LastName': 'van der Putten', 'Affiliation': 'Faculty of Behavioural and Social Sciences, Department of Pedagogy and Educational Sciences, unit of special needs education and youth care, University of Groningen, Grote Rozenstraat 38, Groningen, The Netherlands.'}]",Journal of applied research in intellectual disabilities : JARID,['10.1111/jar.12792']
2360,32789935,Potential markers of healing from Near Infrared Spectroscopy imaging of Venous Leg Ulcer. A randomized controlled clinical trial comparing conventional with Hyperbaric Oxygen treatment.,"The aim of this study is to ascertain whether the simultaneous measurement of hemoglobin O 2  saturation (StO 2  ) and dimension of venous leg ulcers (VLU) by Near Infrared Spectroscopy (NIRS) imaging can predict the healing course with protocols employing a conventional treatment alone or in combination with Hyperbaric Oxygen Therapy (HBOT). NIRS 2D images of wound region were obtained in 81 patients with hard-to-heal VLU that had been assigned, in a randomized controlled clinical trial, to the following protocols: 30 HBOT sessions, adjunctive to the conventional therapy, either twice daily over three weeks (Group A) or once daily over six weeks (Group B), and conventional therapy without HBOT (Group C). Seventy-three patients completed the study with a total of 511 NIRS images being analyzed. At the end of treatment, wound area was significantly smaller in all three groups. However, at the 3-week mark the wound area reduction tended to be less evident in Group A than in the other groups. This trend continued up to the 6-week end-point when a significantly greater area reduction was found with Group B (65.5%) and Group C (56.8%) compared to Group A (29.7%) (p<0.01). Furthermore, a higher incidence of complete healing was noted with Group B (20%) than with Group A (4.5%) and Group C (3.8%). When using a final wound reduction in excess of 40% to distinguish healing from non-healing ulcers, it was found that only the former present NIRS StO 2  values abating over the study period both at center and edge of lesions. In conclusion, NIRS analysis of StO 2  and wound area can predict the healing course of VLU. Adjunctive HBOT significantly facilitates VLU healing compared to the conventional treatment alone. This positive action, however, becomes manifest only with a longer and less intensive treatment schedule.",2020,This trend continued up to the 6-week end-point when a significantly greater area reduction was found with Group B (65.5%) and Group C (56.8%) compared to Group A (29.7%) (p<0.01).,"['Seventy-three patients completed the study with a total of 511 NIRS images being analyzed', '81 patients with hard-to-heal VLU']","['Hyperbaric Oxygen Therapy (HBOT', 'Adjunctive HBOT', 'conventional with Hyperbaric Oxygen treatment', 'conventional therapy without HBOT', 'hemoglobin O 2  saturation (StO 2  ) and dimension of venous leg ulcers (VLU) by Near Infrared Spectroscopy (NIRS) imaging']","['healing course of VLU', 'area reduction', 'wound area', 'complete healing', 'VLU healing']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1321170', 'cui_str': 'Hemoglobin O'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",81.0,0.0281359,This trend continued up to the 6-week end-point when a significantly greater area reduction was found with Group B (65.5%) and Group C (56.8%) compared to Group A (29.7%) (p<0.01).,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Longobardi', 'Affiliation': 'Centro Iperbarico, Ravenna.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Hartwig', 'Affiliation': 'Istituto di Fisiologia Clinica-CNR, Pisa.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Santarella', 'Affiliation': 'Centro Iperbarico, Bologna.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hoxha', 'Affiliation': 'Centro Iperbarico, Ravenna.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Campos', 'Affiliation': 'Centro Iperbarico, Ravenna.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Laurino', 'Affiliation': 'Istituto di Fisiologia Clinica-CNR, Pisa.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Salvo', 'Affiliation': 'Istituto di Fisiologia Clinica-CNR, Pisa.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Trivella', 'Affiliation': 'Istituto di Fisiologia Clinica-CNR, Pisa.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Coceani', 'Affiliation': ""Istituto Scienze della Vita, Scuola Superiore Sant'Anna, Pisa.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rocco', 'Affiliation': 'Dipartimento di Scienze Medico-Chirurgiche e di Medicina Traslazionale, Università degli Studi di Roma ""La Sapienza"".'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': ""L'Abbate"", 'Affiliation': 'Istituto di Fisiologia Clinica-CNR, Pisa.'}]",Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society,['10.1111/wrr.12853']
2361,32789949,Increasing bladder capacity and vesicoureteral reflux in pediatric kidney transplant patients.,"OBJECTIVES


To investigate the frequency of vesicoureteral reflux, and the relationship of pretransplant decreased bladder capacity and post-transplant vesicoureteral reflux in children undergoing kidney transplantation.
METHODS


A voiding cystourethrography was carried out in 172 pediatric kidney transplantation recipients before, and 4 months after, transplantation to evaluate bladder capacity and vesicoureteral reflux. The correlation of post-transplant vesicoureteral reflux with pretransplant bladder capacity, vesicoureteral reflux in the native kidney and the method of ureteral reimplantation (intravesical/extravesical) was analyzed. Atrophic bladder was defined as having ≤50% functional bladder capacity (age in years + 2) × 25 (mL) or ≤150 mL in patients aged >10 years.
RESULTS


Bladder capacity increased remarkably after transplantation in both post-transplant vesicoureteral reflux- group (from 180 to 253 mL) and vesicoureteral reflux+ group (from 82 to 171 mL). Voiding cystourethrography showed vesicoureteral reflux in 12 cases of kidney transplantation (7%; grade 1: 2, grade 2: 3, grade 3: 7). Pretransplant atrophic bladder was an independent risk factor of post-transplant vesicoureteral reflux (P = 0.004, hazard ratio 9.5). There was no difference in renal function between the vesicoureteral reflux- group and vesicoureteral reflux+ group at 4 months to 5 years post-transplantation.
CONCLUSIONS


Pretransplant atrophic bladder is a risk factor of post-transplant vesicoureteral reflux in pediatric patients. However, bladder capacity can remarkably increase after transplantation, and kidney function in the post-transplant vesicoureteral reflux+ group is stable.",2020,"Pretransplant atrophic bladder was an independent risk factor of post-transplant vesicoureteral reflux (P = 0.004, hazard ratio 9.5).","['pediatric kidney transplant patients', 'patients aged >10\xa0years', 'pediatric patients', 'children undergoing kidney transplantation', '172 pediatric kidney transplantation recipients']",[],"['bladder capacity and vesicoureteral reflux', 'renal function', 'Bladder capacity', 'Atrophic bladder', 'Pretransplant atrophic bladder', 'kidney function', 'vesicoureteral reflux']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517601', 'cui_str': '172'}]",[],"[{'cui': 'C0429807', 'cui_str': 'Bladder capacity'}, {'cui': 'C0042580', 'cui_str': 'Vesicoureteric reflux'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]",172.0,0.037424,"Pretransplant atrophic bladder was an independent risk factor of post-transplant vesicoureteral reflux (P = 0.004, hazard ratio 9.5).","[{'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Morizawa', 'Affiliation': ""Departments of, Department of, Urology, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan.""}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Satoh', 'Affiliation': ""Departments of, Department of, Urology, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan.""}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Iwasa', 'Affiliation': ""Departments of, Department of, Urology, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan.""}, {'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Sato', 'Affiliation': ""Departments of, Department of, Urology, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan.""}, {'ForeName': 'Yujiro', 'Initials': 'Y', 'LastName': 'Aoki', 'Affiliation': ""Departments of, Department of, Urology, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan.""}, {'ForeName': 'Ryoko', 'Initials': 'R', 'LastName': 'Harada', 'Affiliation': ""Department of, Nephrology, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan.""}, {'ForeName': 'Riku', 'Initials': 'R', 'LastName': 'Hamada', 'Affiliation': ""Department of, Nephrology, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan.""}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Hataya', 'Affiliation': ""Department of, Nephrology, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan.""}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14348']
2362,32789966,Exposure-Response Analysis of Raltitrexed Assessing Liver Toxicity.,"AIM


Raltitrexed (RTX) is a thymidylate synthase inhibitor with large pharmacokinetics (PK) variability that can be administered in case of 5-fluorouracil (5FU) intolerance or dihydropyrimidine dehydrogenase deficiency (DPD). While it is a more potent thymidylate synthase inhibitor than 5FU, RTX failed to replace this drug for colorectal cancer patients, mainly due to its toxicity at the recommended dose of 3 mg/m 2  every three weeks. However, every two weeks administration at 2 mg/m 2  demonstrated a favourable toxicity profile.
METHOD


We performed a randomized crossover comparative population PK study between every two weeks TOMOX (RTX 2 mg/m 2  ) and every three weeks TOMOX (RTX 3 mg/m 2  ).
RESULTS


A three-compartment model and a proportional error model best describe the data. Creatinine clearance and sex, but not BSA, were covariates of RTX clearance leading to decrease of its interindividual variability of 28%. Weight and body surface area were covariates of central and peripheral volumes of distribution respectively leading to decrease of interindividual variability of 34.6% and 100% respectively. In contrast to the dose, AUC was a good predictor of liver toxicity (p=0.006, OR = 3.91, CI95 = [1.48 - 10.34]). Using covariates to compute individual clearance and a threshold AUC (1.639 - determined in this study), a covariates-based dose was calculated, leading to less variability in AUC than that observed with the actual BSA-based or fixed doses.
CONCLUSION


These results advocate for the use of creatinine clearance and sex to determine the RTX dose instead of BSA.",2020,"In contrast to the dose, AUC was a good predictor of liver toxicity (p=0.006, OR = 3.91, CI95 = [1.48 - 10.34]).",['colorectal cancer patients'],"['Raltitrexed (RTX', 'TOMOX (RTX 2 mg/m 2  ) and every three weeks TOMOX (RTX 3 mg/m 2  ']","['favourable toxicity profile', 'Creatinine clearance and sex', 'liver toxicity']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0585333', 'cui_str': 'Triweekly'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}]",,0.0211644,"In contrast to the dose, AUC was a good predictor of liver toxicity (p=0.006, OR = 3.91, CI95 = [1.48 - 10.34]).","[{'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Royer', 'Affiliation': 'Laboratoire de Pharmacologie Clinique et Toxicologie, CHU Besançon, F-25000, Besançon, France.'}, {'ForeName': 'Antonin', 'Initials': 'A', 'LastName': 'Schmitt', 'Affiliation': 'Service Pharmacie, Centre Georges-François Leclerc, F-21000, Dijon, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': ""Service d'Oncologie médicale, CHU Besançon, F-25000, Besançon, France.""}, {'ForeName': 'Marie-Justine', 'Initials': 'MJ', 'LastName': 'Paillard', 'Affiliation': ""Service d'Oncologie médicale, CHU Besançon, F-25000, Besançon, France.""}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Jary', 'Affiliation': 'Univ. Bourgogne Franche-Comté, INSERM, EFS BFC, UMR1098, Interactions Hôte-Greffon-Tumeur/Ingénierie Cellulaire et Génique, F-25000, Besançon, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Demarchi', 'Affiliation': ""Service d'Oncologie médicale, CHU Besançon, F-25000, Besançon, France.""}, {'ForeName': 'Dewi', 'Initials': 'D', 'LastName': 'Vernerey', 'Affiliation': 'Univ. Bourgogne Franche-Comté, INSERM, EFS BFC, UMR1098, Interactions Hôte-Greffon-Tumeur/Ingénierie Cellulaire et Génique, F-25000, Besançon, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Henriques', 'Affiliation': 'Univ. Bourgogne Franche-Comté, INSERM, EFS BFC, UMR1098, Interactions Hôte-Greffon-Tumeur/Ingénierie Cellulaire et Génique, F-25000, Besançon, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Jacquin', 'Affiliation': 'INSERM CIC-1431, CHU Besançon, F-25000, Besançon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Borg', 'Affiliation': 'Univ. Bourgogne Franche-Comté, INSERM, EFS BFC, UMR1098, Interactions Hôte-Greffon-Tumeur/Ingénierie Cellulaire et Génique, F-25000, Besançon, France.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Univ. Bourgogne Franche-Comté, INSERM, EFS BFC, UMR1098, Interactions Hôte-Greffon-Tumeur/Ingénierie Cellulaire et Génique, F-25000, Besançon, France.'}]",British journal of clinical pharmacology,['10.1111/bcp.14519']
2363,32789987,"The impact of in-person and video-recorded animal experiences on zoo visitors' cognition, affect, empathic concern, and conservation intent.","Currently there are mixed results regarding the ability for media or more specifically video to increase a person's interest in conservation. However, there is a growing amount of evidence that in-person experiences at a zoo or aquarium can increase a person's interest in conservation. The goal of the current study was to examine the difference between an in-person experience viewing a polar bear training session and watching a video of the same experience on cognition, emotion, empathic concern, and conservation intent. A total of 124 Brookfield Zoo members were randomly assigned to one of three conditions. Condition 1 was an in-person 10 min (Live Animal) experience viewing a training session with a polar bear. Condition 2 participants (Video Animal) watched a video of the same experience from Condition 1 and Condition 3 (Control) listened to the audio from Condition 1 but only viewed an image of one of our animal care specialists. Results suggest that the live condition is associated with higher probability of answering questions correctly, having a positive emotional experience, having greater empathic concern for wild bears, and wanting to get involved in conservation when compared to the control. These impacts were not observed for the video condition suggesting that for this study, watching a video of a training session was not an effective tool for getting people involved in conservation. Future research is needed to better understand this important topic, but we now have further evidence of the importance of in-person zoo experiences.",2020,"Results suggest that the live condition is associated with higher probability of answering questions correctly, having a positive emotional experience, having greater empathic concern for wild bears, and wanting to get involved in conservation when compared to the control.",['A total of 124 Brookfield Zoo members'],['Condition 2 participants (Video Animal) watched a video of the same experience from Condition 1 and Condition 3 (Control) listened to the audio from Condition 1 but only viewed an image of one of our animal care specialists'],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0680022', 'cui_str': 'Member of'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}]",[],124.0,0.0589736,"Results suggest that the live condition is associated with higher probability of answering questions correctly, having a positive emotional experience, having greater empathic concern for wild bears, and wanting to get involved in conservation when compared to the control.","[{'ForeName': 'Lance J', 'Initials': 'LJ', 'LastName': 'Miller', 'Affiliation': 'Chicago Zoological Society-Brookfield Zoo, Brookfield, Illinois.'}, {'ForeName': 'Jerry F', 'Initials': 'JF', 'LastName': 'Luebke', 'Affiliation': 'Chicago Zoological Society-Brookfield Zoo, Brookfield, Illinois.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Matiasek', 'Affiliation': 'Chicago Zoological Society-Brookfield Zoo, Brookfield, Illinois.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Granger', 'Affiliation': 'University of California, Irvine, California.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Razal', 'Affiliation': 'Chicago Zoological Society-Brookfield Zoo, Brookfield, Illinois.'}, {'ForeName': 'Heather J B', 'Initials': 'HJB', 'LastName': 'Brooks', 'Affiliation': 'Chicago Zoological Society-Brookfield Zoo, Brookfield, Illinois.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Maas', 'Affiliation': 'Chicago Zoological Society-Brookfield Zoo, Brookfield, Illinois.'}]",Zoo biology,['10.1002/zoo.21565']
2364,32789996,Dupilumab Significantly Improves Sleep Outcomes in Adult Patients with Atopic Dermatitis: Results from Five Randomized Clinical Trials.,"Sleep disturbances are part of a symptom triad, along with itch and pain, that patients with atopic dermatitis (AD) report as being frequent and burdensome. 1  The effects of dupilumab on sleep were evaluated in adults with chronic AD in 5 randomized, double-blind, placebo-controlled clinical trials (N=2632). The phase 2b (NCT01859988) 2  and the two phase 3 SOLO trials (SOLO 1, NCT02277743; SOLO 2, NCT02277769) 3  were 16-week studies of dupilumab monotherapy, the 16-week CAFÉ (NCT02755649) 4  and the 52-week CHRONOS trials (NCT02260986) 5  evaluated dupilumab with concomitant topical corticosteroids (TCS).",2020,"Sleep disturbances are part of a symptom triad, along with itch and pain, that patients with atopic dermatitis (AD) report as being frequent and burdensome.","['patients with atopic dermatitis (AD', 'Adult Patients with Atopic Dermatitis', 'adults with chronic AD']","['placebo', 'Dupilumab', 'dupilumab']","['Sleep Outcomes', 'Sleep disturbances']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}]",3.0,0.193735,"Sleep disturbances are part of a symptom triad, along with itch and pain, that patients with atopic dermatitis (AD) report as being frequent and burdensome.","[{'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Beck', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Silverberg', 'Affiliation': 'Department of Dermatology, The George Washington School of Medicine and Health Sciences, Washington, DC, USA.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Yosipovitch', 'Affiliation': 'Miami Itch Center and Dr Phillip Frost Department of Dermatology & Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Eckert', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Guillemin', 'Affiliation': 'Sanofi, Lyon, France.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NY, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ardeleanu', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NY, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Plaum', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NY, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ruddy', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NY, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pirozzi', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gadkari', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NY, USA.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16865']
2365,32792762,The Effect of Human Chorionic Gonadotropin on the  In vitro  Development of Immature to Mature Human Oocytes: A Randomized Controlled Study.,"Context


In controlled ovarian hyperstimulation cycles, 15% of oocytes have been proven to be immature. Key factors include failure in signal transmission from the cumulus cell to the oocyte, insufficient level of luteinizing hormone, and internal conditions of the oocyte itself.
Aims


The aim of the present study was to investigate the effect of human chorionic gonadotropin (hCG) on the  in vitro  maturity of partially cumulus-denuded immature oocytes collected after controlled ovarian stimulation for  in vitro  fertilization (IVF).
Settings and Design


This was a prospective, randomized controlled design at the department of obstetrics and gynaecology, university hospital.
Subjects and Methods


Infertile women underwent gonadotropin-releasing hormone antagonist stimulated protocol for IVF with final maturation triggered by hCG, partially cumulus-denuded immature human oocytes were allocated to two groups: the first was treated with fertilization medium and the second was treated with fertilization medium and hCG. They were cultured for 24 h. Outcomes measured were the oocyte maturation rates to metaphase II (MII) and glucose-6-phosphate dehydrogenase (G6PD) activity of  in vitro  maturation (IVM) mature oocytes which represent the oocyte quality.
Statistical Analysis Used


The Mann-Whitney U-test and One-way ANOVA were used to compare continuous variables, and Chi-square was used for categorical data.
Results


In all, 250 immature stimulated oocytes were allocated (125 per group). The maturation rate was higher in the hCG supplement group (48% vs. 39.2%) without significance. The positive brilliant cresyl blue results among the MII oocytes developed from the metaphase I (MI) were significantly higher in the hCG group ( P  = 0.001).
Conclusions


Rescue IVM in fertilization culture medium plus hCG was slightly better than that in the only fertilization culture. MII oocytes developed from MI in hCG supplemented medium had a higher quality based on the measured G6PD activity.",2020,The maturation rate was higher in the hCG supplement group (48% vs. 39.2%) without significance.,"['Immature to Mature Human Oocytes', '250 immature stimulated oocytes', 'for IVF with final maturation triggered by hCG, partially cumulus-denuded immature human oocytes', 'Subjects and Methods\n\n\nInfertile women underwent', 'department of obstetrics and gynaecology, university hospital', 'vitro  maturity of partially cumulus-denuded immature oocytes collected after controlled ovarian stimulation for  in vitro  fertilization (IVF']","['Human Chorionic Gonadotropin', 'fertilization medium and the second was treated with fertilization medium and hCG', 'human chorionic gonadotropin (hCG', 'gonadotropin-releasing hormone antagonist stimulated protocol', 'hCG']","['oocyte maturation rates to metaphase II (MII) and glucose-6-phosphate dehydrogenase (G6PD) activity of  in vitro  maturation (IVM) mature oocytes which represent the oocyte quality', 'maturation rate', 'G6PD activity', 'metaphase I (MI']","[{'cui': 'C0205252', 'cui_str': 'Immature'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0029974', 'cui_str': 'Ovum'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C3160898', 'cui_str': 'Controlled ovarian stimulation'}]","[{'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C1621812', 'cui_str': 'Metaphase'}, {'cui': 'C0017757', 'cui_str': 'Glucose-6-phosphate dehydrogenase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0427508', 'cui_str': 'Glucose-6-phosphate dehydrogenase measurement, quantitative'}]",250.0,0.0948052,The maturation rate was higher in the hCG supplement group (48% vs. 39.2%) without significance.,"[{'ForeName': 'Chananya', 'Initials': 'C', 'LastName': 'Tantitham', 'Affiliation': 'Department of Obstetrics and Gynaecology, Reproductive Endocrinology and Infertility Unit, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sitanan', 'Initials': 'S', 'LastName': 'Panunumpa', 'Affiliation': 'Department of Obstetrics and Gynaecology, Reproductive Endocrinology and Infertility Unit, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chonthicha', 'Initials': 'C', 'LastName': 'Satirapod', 'Affiliation': 'Department of Obstetrics and Gynaecology, Reproductive Endocrinology and Infertility Unit, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}]",Journal of human reproductive sciences,['10.4103/jhrs.JHRS_1_20']
2366,32792765,Follicular Flushing Versus Direct Aspiration at Oocyte Retrieval in Poor Responders Undergoing  in vitro  Fertilization: A Randomized Controlled Trial.,"Aim


This study aims to study the effect of follicular flushing at oocyte retrieval on Assisted Reproductive Technique (ART) outcomes in poor responders undergoing  in vitro  fertilization.
Settings and Design


A prospective randomized controlled trial was conducted in the ART center of our hospital.
Materials and Methods


A total of 71 patients who responded poorly during controlled ovarian stimulation were recruited. Patients were randomized to follicular flushing or to direct aspiration group. The primary outcomes of the study were the total number of oocytes retrieved and the number of metaphase (M II) oocytes retrieved. Secondary outcomes were anesthesia time, procedure time, fertilization rate, cleavage rate, total number of embryos, number of embryos transferred, number of Grade 1 embryos, failed oocyte recovery, failed fertilization, implantation rate, clinical pregnancy rate, miscarriage rate, and live birth rate.
Statistical Analysis Used


Chi-square test and Student's  t -test.
Results


The total number of oocytes retrieved, number of M II oocytes, fertilization rate, cleavage rate, total number of embryos, number of Grade 1 embryos, failed oocyte recovery, failed fertilization, implantation rate, miscarriage rate, and live birth rate were comparable between the two groups. The anesthesia and procedure time was significantly higher in the flushing group.
Conclusions


Follicular flushing does not result in a significant improvement in the ART outcomes despite increasing procedure and anesthesia times.Trial registration number CTRI/2017/07/009062.",2020,"The anesthesia and procedure time was significantly higher in the flushing group.
","['71 patients who responded poorly during controlled ovarian stimulation were recruited', 'poor responders undergoing  in vitro  fertilization', 'Poor Responders Undergoing  in vitro  Fertilization']","['follicular flushing at oocyte retrieval', 'follicular flushing or to direct aspiration group', 'Follicular Flushing Versus Direct Aspiration at Oocyte Retrieval']","['total number of oocytes retrieved and the number of metaphase (M II) oocytes retrieved', 'total number of oocytes retrieved, number of M II oocytes, fertilization rate, cleavage rate, total number of embryos, number of Grade 1 embryos, failed oocyte recovery, failed fertilization, implantation rate, miscarriage rate, and live birth rate', 'anesthesia time, procedure time, fertilization rate, cleavage rate, total number of embryos, number of embryos transferred, number of Grade 1 embryos, failed oocyte recovery, failed fertilization, implantation rate, clinical pregnancy rate, miscarriage rate, and live birth rate', 'anesthesia and procedure time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205169', 'cui_str': 'Bad'}, {'cui': 'C3160898', 'cui_str': 'Controlled ovarian stimulation'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}]","[{'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0404268', 'cui_str': 'Oocyte recovery'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1621812', 'cui_str': 'Metaphase'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0010813', 'cui_str': 'Cytokinesis'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0404268', 'cui_str': 'Oocyte recovery'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449951', 'cui_str': 'Number of embryos transferred'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}]",71.0,0.269925,"The anesthesia and procedure time was significantly higher in the flushing group.
","[{'ForeName': 'Neena', 'Initials': 'N', 'LastName': 'Malhotra', 'Affiliation': 'Department of Obstetrics and Gynaecology, ART Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Chithira Pulimoottil', 'Initials': 'CP', 'LastName': 'Vignarajan', 'Affiliation': 'Department of Obstetrics and Gynaecology, ART Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Disket', 'Initials': 'D', 'LastName': 'Dolkar', 'Affiliation': 'Department of Obstetrics and Gynaecology, ART Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Reeta', 'Initials': 'R', 'LastName': 'Mahey', 'Affiliation': 'Department of Obstetrics and Gynaecology, ART Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Perumal', 'Initials': 'P', 'LastName': 'Vanamail', 'Affiliation': 'Department of Obstetrics and Gynaecology, ART Center, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of human reproductive sciences,['10.4103/jhrs.JHRS_59_19']
2367,32792771,Comparative Evaluation of Therapeutic Efficacy of Intralesional Injection of Triamcinolone Acetonide versus Intralesional Autologous Platelet-rich Plasma Injection in Alopecia Areata.,"Context


Alopecia areata is a chronic non-scarring alopecia that involves scalp and/or body. Corticosteroids are the most popular drugs for its treatment.
Aim


The aim of the study was to evaluate the therapeutic efficacy of intralesional injection of triamcinolone acetonide and platelet-rich plasma (PRP) in alopecia areata and to compare the efficacy of these modalities in alopecia areata.
Settings and Design


This was a randomized controlled comparative study.
Subjects and Methods


Forty patients were enrolled from the outpatient department and divided into two groups of 20 patients each. Group A and B randomly received intradermal triamcinolone acetonide suspension (10 mg/mL) and PRP, respectively, into the lesion using an insulin syringe in multiple 0.1 mL injections 1cm apart. The injections were repeated every 3 weeks till 12 weeks. The patients were evaluated by Severity of Alopecia Tool (SALT) score and photographically every 3 weeks till the end of 12 weeks and then at the end of 6 months. Statistical analysis used descriptive analysis along with Pearson chi-square test or Fisher exact test, paired samples, and independent samples  t  test or their nonparametric analogs for continuous variables.
Results


The reduction in SALT score at each visit with respect to baseline was greater in the triamcinolone group as compared to PRP group. This signifies greater effect of triamcinolone in alopecia areata. Around 50% patients in triamcinolone group and 5% patients in PRP group showed grade V improvement. Pain during intralesional injection was higher in the PRP group.
Conclusion


Both intralesional triamcinolone and PRP were found to be efficacious in alopecia areata but the latter produced lesser improvement.",2020,The reduction in SALT score at each visit with respect to baseline was greater in the triamcinolone group as compared to PRP group.,"['Subjects and Methods\n\n\nForty patients were enrolled from the outpatient department and divided into two groups of 20 patients each', 'Alopecia Areata', 'alopecia areata']","['PRP', 'triamcinolone', 'intralesional triamcinolone', 'Triamcinolone Acetonide', 'Corticosteroids', 'intradermal triamcinolone acetonide suspension', 'Intralesional Autologous Platelet-rich Plasma Injection', 'triamcinolone acetonide and platelet-rich plasma (PRP']","['Severity of Alopecia Tool (SALT) score', 'grade V improvement', 'Pain', 'SALT score', 'alopecia areata']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",40.0,0.0244309,The reduction in SALT score at each visit with respect to baseline was greater in the triamcinolone group as compared to PRP group.,"[{'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Kapoor', 'Affiliation': 'Department of Dermatology, Guru Gobind Singh Medical College and Hospital, Faridkot, India.'}, {'ForeName': 'Sumir', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Department of Dermatology, Guru Gobind Singh Medical College and Hospital, Faridkot, India.'}, {'ForeName': 'Balvinder K', 'Initials': 'BK', 'LastName': 'Brar', 'Affiliation': 'Department of Dermatology, Guru Gobind Singh Medical College and Hospital, Faridkot, India.'}, {'ForeName': 'Neetu', 'Initials': 'N', 'LastName': 'Kukar', 'Affiliation': 'Department of Immunohaematology and Blood Transfusion, Guru Gobind Singh Medical College and Hospital, Faridkot, India.'}, {'ForeName': 'Hobinder', 'Initials': 'H', 'LastName': 'Arora', 'Affiliation': 'Department of Community Medicine, Guru Gobind Singh Medical College and Hospital, Faridkot, India.'}, {'ForeName': 'Sukhmani K', 'Initials': 'SK', 'LastName': 'Brar', 'Affiliation': 'Department of Dermatology, Adesh Institute of Medical Sciences and Research, Bathinda, Punjab, India.'}]",Journal of cutaneous and aesthetic surgery,['10.4103/JCAS.JCAS_16_19']
2368,32792818,Comparative Evaluation of the Remineralizing Potential of Commercially Available Agents on Artificially Demineralized Human Enamel: An  In vitro  Study.,"Background


Caries is highly prevalent multifactorial disease, but its progression can be prevented in the initial stage of demineralization through remineralization (RML). Various materials have been proposed for the same, successful outcome can prove to be a boon in the prevention of caries.
Aim


The aim of the study is to assess the RML potential of four commercially available agents so as to restore the enamel closest to its previous microhardness levels.
Materials and Methods


Sixty permanent intact premolars were randomly divided into six groups: Four test groups - (1) bioactive glass (BAG) Novamin (SHY-NM), (2) nano-hydroxyapatite (nHAp) (Acclaim), (3) functionalized tricalcium phosphate (f-TCP) (Clinpro Tooth Crème), and (4) grape seed extract (GSE); one positive control - (5) fluoride (1000 ppm) containing dentifrice (Colgate Calci-Lock); and one negative control - (6) distilled water. The samples were initially evaluated for baseline surface microhardness (SMH); later on, these samples were placed in the demineralizing solution for 48 h in an incubator at 37°C, and postdemineralization again SMH was measured. Thereafter, the samples were subjected to the pH cycling for consecutive 21 days, and SMH was recorded. The SMH was evaluated using a Vickers microhardness tester. Statistical analysis was done using a  post hoc  Tukey test for each group based on the stage of treatment and one-way ANOVA for comparison among different groups.
Results


BAG Novamin showed SMH recovery at 96.75% followed by f-TCP at 95.83%, nHAp at 90.88%, and GSE at 48.71%. Statistically significant differences were observed between the first three groups and the rest of the groups after RML stage.
Conclusion


BAG Novamin, f-TCP, and nHAp showed considerable RML followed to a lesser extent by GSE.",2019,"Various materials have been proposed for the same, successful outcome can prove to be a boon in the prevention of caries.
","['Artificially Demineralized Human Enamel', 'Materials and Methods\n\n\nSixty permanent intact premolars']","['bioactive glass (BAG) Novamin (SHY-NM), (2) nano-hydroxyapatite (nHAp) (Acclaim), (3) functionalized tricalcium phosphate (f-TCP) (Clinpro Tooth Crème), and (4) grape seed extract (GSE); one positive control - (5) fluoride (1000 ppm) containing dentifrice (Colgate Calci-Lock); and one negative control - (6) distilled water']",['SMH recovery'],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C1722474', 'cui_str': 'NovaMin'}, {'cui': 'C0557869', 'cui_str': 'Introvert'}, {'cui': 'C0020326', 'cui_str': 'Hydroxyapatite Derivatives'}, {'cui': 'C0108136', 'cui_str': 'tricalcium phosphate'}, {'cui': 'C0044091', 'cui_str': '1-(1-(2-thienyl) cyclohexyl) piperidine'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0772454', 'cui_str': 'Grape Seed Extract'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C2345900', 'cui_str': 'Colgate'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]",[],,0.0337348,"Various materials have been proposed for the same, successful outcome can prove to be a boon in the prevention of caries.
","[{'ForeName': 'Chintan', 'Initials': 'C', 'LastName': 'Joshi', 'Affiliation': 'Department of Conservative and Endodontics, Karnavati School of Dentistry, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Gohil', 'Affiliation': 'Department of Conservative and Endodontics, Karnavati School of Dentistry, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Parekh', 'Affiliation': 'Department of Conservative and Endodontics, Karnavati School of Dentistry, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Surabhi', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': 'Department of Periodontics, Karnavati School of Dentistry, Ahmedabad, Gujarat, India.'}]",Contemporary clinical dentistry,['10.4103/ccd.ccd_679_18']
2369,32792820,Volumetric Analysis of Root Canal Filling in Deciduous Teeth after Using Different Canal-Drying Methods: An  In-vitro  Study.,"Background


Drying the root canals in pulp therapy is often ignored, but is essential for a successful clinical outcome. The conventional method used for drying root canals is by the use of paper points, but recently, various other methods have also been employed for this purpose.
Aim


The purpose of this study was to volumetrically analyze root canal fillings in deciduous teeth, after using different canal-drying methods namely 95% ethanol, CANAL CLEAN (Cerkamed Medical Company), and Endo-Aspirator (Cerkamed Medical Company), and compare with the conventional paper point drying method.
Methodology


Access cavities were prepared on eighty extracted primary canines, and irrigation was done with 1% sodium hypochlorite and normal saline while enlarging the canals. The specimens were then scanned using a cone-beam computed tomography (CBCT), and preobturation volume (X) of each tooth was measured. The teeth were then randomly divided into two groups - Group 1 - Zinc oxide eugenol (ZOE) group and Group 2 - Metapex group. Each group was further divided randomly into four subgroups based on the drying agent used - Subgroup A - Control group, Subgroup B - 95% ethanol group, Subgroup C - CANAL CLEAN group, and Subgroup D - Endo-Aspirator group. After obturation, a second CBCT was taken to measure the postobturation volume (Y). The percentage of obturated volume was calculated by the following formula: (postobturation volume/preobturation volume) ×100 ([ Y / X ] ×100).
Statistical Analysis


The obtained data were tabulated and subjected to statistical analysis using one-way ANOVA test and unpaired  t -test.
Results


A significantly high postobturation volume was seen after using 95% ethanol followed by CANAL CLEAN, Endo-Aspirator, and paper points. On comparing the obturation volumes within Metapex and ZOE groups, Metapex group had significantly high obturation volumes irrespective of the drying method used.
Conclusion


95% ethanol is the best intracanal drying agent as it provides optimum pupal obturation.",2019,"A significantly high postobturation volume was seen after using 95% ethanol followed by CANAL CLEAN, Endo-Aspirator, and paper points.",[],"['Zinc oxide eugenol (ZOE) group and Group 2 - Metapex group', 'sodium hypochlorite and normal saline while enlarging the canals', 'canal-drying methods namely 95% ethanol, CANAL CLEAN (Cerkamed Medical Company), and Endo-Aspirator (Cerkamed Medical Company', 'drying agent used - Subgroup A - Control group, Subgroup B - 95% ethanol group, Subgroup C - CANAL CLEAN group, and Subgroup D - Endo-Aspirator group']",['percentage of obturated volume'],[],"[{'cui': 'C0043492', 'cui_str': 'Zinc oxide eugenol dental cement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C1567041', 'cui_str': 'Metapex'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0442800', 'cui_str': 'Enlarged'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0042226', 'cui_str': 'Aspirator'}, {'cui': 'C2936384', 'cui_str': 'Drying Agents'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",80.0,0.0205323,"A significantly high postobturation volume was seen after using 95% ethanol followed by CANAL CLEAN, Endo-Aspirator, and paper points.","[{'ForeName': 'C S Sri', 'Initials': 'CSS', 'LastName': 'Darshini', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, A.E.C.S Maaruti College of Dental Sciences, Bengaluru, Karnataka, India.'}, {'ForeName': 'Preetha', 'Initials': 'P', 'LastName': 'Peethambar', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, A.E.C.S Maaruti College of Dental Sciences, Bengaluru, Karnataka, India.'}, {'ForeName': 'Sapna', 'Initials': 'S', 'LastName': 'Konde', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, A.E.C.S Maaruti College of Dental Sciences, Bengaluru, Karnataka, India.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Agarwal', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, A.E.C.S Maaruti College of Dental Sciences, Bengaluru, Karnataka, India.'}]",Contemporary clinical dentistry,['10.4103/ccd.ccd_896_18']
2370,32792824,Efficacy of Platelet-rich Fibrin in Interdental Papilla Reconstruction as Compared to Connective Tissue Using Microsurgical Approach.,"Aim


This study aims to evaluate autologous platelet-rich fibrin (PRF) and autogenous connective tissue graft (CTG) in interdental papilla (IDP) reconstruction with buccal and palatal split-thickness flap (STF) using microsurgical technique.
Materials and Methods


Forty Class I or Class II open gingival or cervical embrasure in maxillary anterior region in 14 patients were surgical treated for the reconstruction of IDP. For experimental Group I (STF with PRF,  n  = 20), surgical site was flushed with PRF fluid. PRF was then placed under the buccal flap and in the IDP region and squeezed. For experimental Group II (STF with CTG,  n  = 20) after the preparation of recipient site, CTG procured from palate was trimmed to the desired size and shape and placed at the site. Clinical parameters and patient satisfaction response recorded were plaque index, gingival index, probing pocket depth, clinical attachment level, height of IPD, and papilla index score (PIS).
Results


STF surgery in combination with PRF or CTG, are an effective procedure to increase IDP-height with mean values of 3.10 mm (87.3%) and 3.45 mm (95.8%) for Group I (STF + PRF) and Group II (STF + CTG), respectively. In terms of complete fill (CF) achieved at 3 months, in the present study, the result showed that 90% CF was obtained in Group I (STF + PRF) and 95% in Group II (STF + CTG). The patient response and acceptance for surgical treatment modality in terms of patient postsurgical discomfort score and patient esthetic score was higher for Group II (STF + CTG) than Group I (STF + PRF).
Conclusion


Based on single-centered 3 months' follow-up, it may be concluded that STF surgery in combination with PRF or CTG is an effective procedure to increase IDP-height; however, a long-term multicentric randomized clinical trial may be necessary to evaluate the clinical outcome for autologous PRF in comparison to CTG with STF.",2019,"Results


STF surgery in combination with PRF or CTG, are an effective procedure to increase IDP-height with mean values of 3.10 mm (87.3%) and 3.45 mm (95.8%) for Group I (STF + PRF) and Group II (STF + CTG), respectively.",['14 patients were surgical treated for the reconstruction of IDP'],"['buccal and palatal split-thickness flap (STF', 'Platelet-rich Fibrin', 'autologous platelet-rich fibrin (PRF) and autogenous connective tissue graft (CTG', 'Materials and Methods\n\n\nForty Class I or Class II open gingival or cervical embrasure', 'PRF or CTG']","['IDP-height', 'patient postsurgical discomfort score and patient esthetic score', 'plaque index, gingival index, probing pocket depth, clinical attachment level, height of IPD, and papilla index score (PIS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C1185949', 'cui_str': 'Structure of interdental papilla of gingiva'}]","[{'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1291062', 'cui_str': 'Embrasure'}]","[{'cui': 'C1185949', 'cui_str': 'Structure of interdental papilla of gingiva'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0226964', 'cui_str': 'Structure of lingual papillae'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",14.0,0.0499324,"Results


STF surgery in combination with PRF or CTG, are an effective procedure to increase IDP-height with mean values of 3.10 mm (87.3%) and 3.45 mm (95.8%) for Group I (STF + PRF) and Group II (STF + CTG), respectively.","[{'ForeName': 'Dhanavendra', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Department of Periodontology, Saraswati Dental College, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Jhingran', 'Affiliation': 'Department of Periodontology, Saraswati Dental College, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Vivek Kumar', 'Initials': 'VK', 'LastName': 'Bains', 'Affiliation': 'Department of Periodontology, Saraswati Dental College, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Madan', 'Affiliation': 'Department of Periodontology, Saraswati Dental College, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Ruchi', 'Initials': 'R', 'LastName': 'Srivastava', 'Affiliation': 'Department of Periodontology, Saraswati Dental College, Lucknow, Uttar Pradesh, India.'}]",Contemporary clinical dentistry,['10.4103/ccd.ccd_936_18']
2371,32792897,Implementing Mobile HRV Biofeedback as Adjunctive Therapy During Inpatient Psychiatric Rehabilitation Facilitates Recovery of Depressive Symptoms and Enhances Autonomic Functioning Short-Term: A 1-Year Pre-Post-intervention Follow-Up Pilot Study.,"Objective


New treatment options for depression are warranted, due to high recurrence rates. Recent research indicates benefits of heart rate variability biofeedback (HRVBF) on symptom recovery and autonomic functioning in depressed individuals. Slow-paced breathing-induced amplification of vagus nerve activity is the main element of HRVBF. Thus, the latter represents a safe and non-invasive complementary depression treatment. However, its efficacy in patients undergoing inpatient psychiatric rehabilitation receiving highly comprehensive treatments has not been evaluated.
Methods


Ninety-two inpatients were randomly assigned to an intervention group (IG) or control group (CG). While the latter received the standard treatment only, adjunctive HRVBF was provided to the IG over 5 weeks. Depression severity and heart rate variability (HRV) were assessed before (pre) and after 5 weeks (post). Moreover, 1-year follow-up depression scores were available for 30 participants.
Results


Although depression improved in both groups, the IG exhibited significantly larger improvements at post-assessment (  η   p   2    = 0.065) and significant increases in resting LF-HRV ( d  = 0.45) and cardiorespiratory coherence ( d  = 0.61). No significant effects for RMSSD, SDNN, HF-HRV, or HR were found ( p s > 0.05). Additionally, the IG showed a medium- to large-sized reduction in resting respiratory rate from 13.2 to 9.8 breaths per minute ( p  < 0.001,  d  = 0.86), with the CG exhibiting only a small decrease from 13.5 to 12.4 ( p  = 0.49;  d  = 0.35). While the IG exhibited significantly lower depression scores at post-assessment ( p  = 0.042,  d  = 0.79), this effect decreased during follow-up ( p  = 0.195,  d  = 0.48).
Conclusion


HRVBF as adjuvant therapy during inpatient psychiatric rehabilitation facilitated depression recovery. Additionally, amplified LF-HRV as well as cardiorespiratory coherence at rest and a decrease in resting breathing frequency was observed in the HRVBF group. These findings emphasize HRVBF's value as complementary therapy regardless of concurrent treatments. Moreover, these incremental benefits could serve as resource even after the actual training period. However, the additional antidepressant gains vanish during the long-term follow-up, indicating the need for more intense training or regular practice afterward, respectively. Thus, future studies are warranted to examine how the initial benefits of HRVBF during inpatient psychiatric rehabilitation can be preserved post discharge.",2020,"No significant effects for RMSSD, SDNN, HF-HRV, or HR were found ( p s > 0.05).","['patients undergoing inpatient psychiatric rehabilitation receiving highly comprehensive treatments', 'depressed individuals', 'Methods\n\n\nNinety-two inpatients']","['heart rate variability biofeedback (HRVBF', 'HRVBF', 'intervention group (IG) or control group (CG', 'Implementing Mobile HRV Biofeedback as Adjunctive Therapy', 'adjunctive HRVBF']","['resting LF-HRV', 'resting breathing frequency', 'depression scores', 'Depression severity and heart rate variability (HRV', '1-year follow-up depression scores', 'symptom recovery and autonomic functioning', 'resting respiratory rate', 'cardiorespiratory coherence', 'RMSSD, SDNN, HF-HRV, or HR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}]",92.0,0.0379909,"No significant effects for RMSSD, SDNN, HF-HRV, or HR were found ( p s > 0.05).","[{'ForeName': 'Josef M', 'Initials': 'JM', 'LastName': 'Tatschl', 'Affiliation': 'Health Psychology Unit, Institute of Psychology, University of Graz, Graz, Austria.'}, {'ForeName': 'Sigurd M', 'Initials': 'SM', 'LastName': 'Hochfellner', 'Affiliation': 'Privatklinik St. Radegund Betriebs GmbH, St. Radegund, Austria.'}, {'ForeName': 'Andreas R', 'Initials': 'AR', 'LastName': 'Schwerdtfeger', 'Affiliation': 'Health Psychology Unit, Institute of Psychology, University of Graz, Graz, Austria.'}]",Frontiers in neuroscience,['10.3389/fnins.2020.00738']
2372,32793080,The Effect of Response Inhibition Training on Risky Decision-Making Task Performance.,"Response inhibition is an important component of executive function and plays an indispensable role in decision-making and other advanced cognitive processes. At the same time, we need an effective way to improve decision-making in the face of complex and limited information. This study mainly explored the influence of response inhibition training on college students' risky decision-making. The recruited students were randomly divided into the training group ( n  = 28) and the control group ( n  = 28). The training group engaged in Go/NoGo and stop-signal tasks for 2 weeks, while the control group was given the task of reading and summarizing popular science articles related to self-control. The Stroop task and Balloon Analog Risk Task were used to evaluate the pretest and posttest performance in inhibitory control and risky decision-making tasks, respectively, for all subjects. The results showed that response inhibition training can be effectively transferred to interference control task performance. The results showed that both the reward acquired and adjusted Balloon Analog Risk Task score (adj BART) significantly improved compared to the pretest in the training group, while the control group showed no significant differences in the reward acquired and the adj BART between the pretest and the posttest. Although response inhibition training increased risky behaviors in the Balloon Analog Risk Task, it substantially reduced overly conservative behaviors and participants gained more money.",2020,"Although response inhibition training increased risky behaviors in the Balloon Analog Risk Task, it substantially reduced overly conservative behaviors and participants gained more money.","[""college students' risky decision-making""]","['training group engaged in Go/NoGo and stop-signal tasks for 2 weeks, while the control group was given the task of reading and summarizing popular science articles related to self-control', 'Response Inhibition Training', 'response inhibition training']","['reward acquired and adjusted Balloon Analog Risk Task score (adj BART', 'risky behaviors', 'reward acquired and the adj BART', 'Risky Decision-Making Task Performance', 'Stroop task and Balloon Analog Risk Task']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}]",,0.0127499,"Although response inhibition training increased risky behaviors in the Balloon Analog Risk Task, it substantially reduced overly conservative behaviors and participants gained more money.","[{'ForeName': 'Pengbo', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': ""Department of Medical Psychology, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ""Department of Medical Psychology, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Yuqin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of Medical Psychology, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Ziwei', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Medical Psychology, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': ""Department of Medical Psychology, Air Force Medical University, Xi'an, China.""}]",Frontiers in psychology,['10.3389/fpsyg.2020.01806']
2373,32793096,"Effect of a High-Intensity Tandem Bicycle Exercise Program on Clinical Severity, Functional Magnetic Resonance Imaging, and Plasma Biomarkers in Parkinson's Disease.","Rationale:  The optimal modality, intensity, duration, frequency, and dose-response of exercise as a therapy for Parkinson's Disease (PD) are insufficiently understood.  Objective:  To assess the impact of a high-intensity tandem bicycle program on clinical severity, biomarkers, and functional MRI (fMRI) in PD.  Methods:  A single-center, parallel-group clinical trial was conducted. Thirteen PD patients aged 65 or younger were divided in two groups: a control group and an intervention group that incorporated a cycling program at 80% of each individual's maximum heart rate (HR) (≥80 rpm), three times a week, for 16 weeks. Both groups continued their conventional medications for PD. At baseline and at the end of follow-up, we determined in all participants the Unified Parkinson's Disease Rating Scale, anthropometry, VO 2 max, PD biomarkers, and fMRI.  Results:  VO 2 max improved in the intervention group (IG) (+5.7 ml/kg/min), while it slightly deteriorated in the control group (CG) (-1.6 ml/kg/min) ( p  = 0.041). Mean Unified Parkinson's Disease Rating Scale (UPDRS) went down by 5.7 points in the IG and showed a small 0.9-point increase in the CG ( p  = 0.11). fMRI showed activation of the right fusiform gyrus during the motor task and functional connectivity between the cingulum and areas of the frontal cortex, and between the cerebellar vermis and the thalamus and posterior temporal gyrus. Plasma brain-derived neurotrophic factor (BDNF) levels increased more than 10-fold in the IG and decreased in the CG ( p  = 0.028). Larger increases in plasma BDNF correlated with greater decreases in UPDRS ( r  = -0.58,  p  = 0.04).  Conclusions:  Our findings suggest that high-intensity tandem bicycle improves motor function and biochemical and functional neuroimaging variables in PD patients.  Trial registration number:  ISRCTN 13047118, Registered on February 8, 2018.",2020,Mean Unified Parkinson's Disease Rating Scale (UPDRS) went down by 5.7 points in the IG and showed a small 0.9-point increase in the CG ( p  = 0.11).,"[""Parkinson's Disease (PD"", 'PD patients', ""Parkinson's Disease"", 'Thirteen PD patients aged 65 or younger']","['control group and an intervention group that incorporated a cycling program', 'high-intensity tandem bicycle program', 'High-Intensity Tandem Bicycle Exercise Program']","['VO 2 max', 'clinical severity, biomarkers, and functional MRI (fMRI', ""Unified Parkinson's Disease Rating Scale, anthropometry, VO 2 max, PD biomarkers, and fMRI"", 'plasma BDNF', 'motor function and biochemical and functional neuroimaging variables', ""Mean Unified Parkinson's Disease Rating Scale (UPDRS"", 'Plasma brain-derived neurotrophic factor (BDNF) levels', 'UPDRS', 'Clinical Severity, Functional Magnetic Resonance Imaging, and Plasma Biomarkers']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C3178877', 'cui_str': 'Functional Neuroimaging'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.062522,Mean Unified Parkinson's Disease Rating Scale (UPDRS) went down by 5.7 points in the IG and showed a small 0.9-point increase in the CG ( p  = 0.11).,"[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Segura', 'Affiliation': 'Vida Activa, Department of Internal Medicine, Fundación Santa Fe de Bogotá, Bogota, Colombia.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Eraso', 'Affiliation': 'Vida Activa, Department of Internal Medicine, Fundación Santa Fe de Bogotá, Bogota, Colombia.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Bonilla', 'Affiliation': 'School of Medicine and Health Sciences, Universidad del Rosario, Bogota, Colombia.'}, {'ForeName': 'Carlos O', 'Initials': 'CO', 'LastName': 'Mendivil', 'Affiliation': 'School of Medicine, Universidad de los Andes, Bogota, Colombia.'}, {'ForeName': 'Giselle', 'Initials': 'G', 'LastName': 'Santiago', 'Affiliation': 'Radiology and Diagnostic Imaging Department, Fundación Santa Fe de Bogotá, Bogota, Colombia.'}, {'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Useche', 'Affiliation': 'Radiology and Diagnostic Imaging Department, Fundación Santa Fe de Bogotá, Bogota, Colombia.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Bernal-Pacheco', 'Affiliation': 'Neurology Department, Fundación Santa Fe de Bogotá, Bogota, Colombia.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Monsalve', 'Affiliation': 'Neurosurgery Section, Department of Surgery, Fundación Santa Fe de Bogotá, Bogota, Colombia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Sanchez', 'Affiliation': 'School of Medicine and Health Sciences, Universidad del Rosario, Bogota, Colombia.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Hernández', 'Affiliation': 'School of Medicine and Health Sciences, Universidad del Rosario, Bogota, Colombia.'}, {'ForeName': 'Maria José', 'Initials': 'MJ', 'LastName': 'Peláez-Jaramillo', 'Affiliation': 'School of Medicine, Universidad de los Andes, Bogota, Colombia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Cárdenas-Mojica', 'Affiliation': 'School of Medicine, Universidad de los Andes, Bogota, Colombia.'}]",Frontiers in neurology,['10.3389/fneur.2020.00656']
2374,32793109,"An Exploratory Clinical Study on an Automated, Speed-Sensing Treadmill Prototype With Partial Body Weight Support for Hemiparetic Gait Rehabilitation in Subacute and Chronic Stroke Patients.","Impairments in walking speed, capacity, and endurance are commonly seen after stroke. Treadmill training improves endurance and gait speed. However, the lack of variable training speed and automated speed progression increases the risk of backward displacement and falling. An automated, speed-sensing treadmill prototype with partial body weight support, the Variable Automated Speed and Sensing Treadmill II (VASST II), was tested in an outpatient rehabilitation setting. Eleven subacute or chronic hemiplegics who could ambulate at > 0.2 m/s for >50 m participated in the study. All subjects underwent physiotherapist-supervised training on VASST II for 60 min daily, 3 times per week, for 5 weeks (total 15 h). Outcome measures at Week 3 (mid-VASST II training), Week 6 (post-VASST II training), Week 12 (first follow-up), and Week 24 (second follow-up) included the 6 minute walk test (6 MWT), 10 meter walk test (10 MWT), Berg Balance Scale (BBS) score, and Functional Ambulation category (FAC) score. User acceptability of VASST II for both study subjects and physiotherapists were also assessed. All subjects [median (IQR) age: 53.0 (22) years; median (IQR) duration post-stroke: 524 (811) days] completed VASST II training. At baseline, mean ± SD 6 MWT was 114 ± 50.9 m; mean ± SD 10 MWT was 0.37 ± 0.18 m/s; mean ± SD BBS score was 40 ± 10; and, mean ± SD FAC score was 4 ± 1. At Week 6, there were significant improvements in the 6 MWT [158.91 ± 88.69 m;  P  = 0.003], 10 MWT [0.49 ± 0.30 m/s;  P  = 0.016], and BBS score [42 ± 10;  P  = 0.003]. Improvements in 6 MWT and BBS scores were sustained at Week 24, but not in the 10 MWT. No VASST II-training related falls were reported. All subjects rated their VASST II training positively and indicated that it improved their current walking ability. VASST II training was effective, feasible, and safe in patients with subacute or chronic post-stroke hemiparetic gait, with sustained gains in distance walked (6 MWT) and functional balance (BBS score) up to 19 weeks post-intervention.",2020,"VASST II training was effective, feasible, and safe in patients with subacute or chronic post-stroke hemiparetic gait, with sustained gains in distance walked (6 MWT) and functional balance (BBS score) up to 19 weeks post-intervention.","['Subacute and Chronic Stroke Patients', 'All subjects [median (IQR) age: 53.0 (22) years; median (IQR) duration post-stroke: 524 (811) days] completed VASST II training', 'Eleven subacute or chronic hemiplegics who could ambulate at > 0.2 m', 'patients with subacute or chronic post-stroke hemiparetic gait']","['Treadmill training', 'VASST II training', 'Automated, Speed-Sensing Treadmill Prototype', 'Partial Body Weight Support for Hemiparetic Gait Rehabilitation', 'VASST', 'speed-sensing treadmill prototype with partial body weight support, the Variable Automated Speed and Sensing Treadmill II (VASST II', 'physiotherapist-supervised training on VASST']","['endurance and gait speed', 'walking speed, capacity, and endurance', 'BBS score', 'current walking ability', 'mean ± SD FAC score', '6 minute walk test (6 MWT), 10 meter walk test (10 MWT), Berg Balance Scale (BBS) score, and Functional Ambulation category (FAC) score', 'BBS scores', 'distance walked (6 MWT) and functional balance (BBS score']","[{'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}]","[{'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",,0.0277495,"VASST II training was effective, feasible, and safe in patients with subacute or chronic post-stroke hemiparetic gait, with sustained gains in distance walked (6 MWT) and functional balance (BBS score) up to 19 weeks post-intervention.","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Chua', 'Affiliation': 'Department of Rehabilitation Medicine, Centre of Advanced Rehabilitation Therapeutics, Tan Tock Seng Hospital Rehabilitation Centre, Singapore, Singapore.'}, {'ForeName': 'Wei Sheong', 'Initials': 'WS', 'LastName': 'Lim', 'Affiliation': 'Department of Rehabilitation Medicine, Centre of Advanced Rehabilitation Therapeutics, Tan Tock Seng Hospital Rehabilitation Centre, Singapore, Singapore.'}, {'ForeName': 'Pang Hung', 'Initials': 'PH', 'LastName': 'Lim', 'Affiliation': 'Department of Rehabilitation Medicine, Centre of Advanced Rehabilitation Therapeutics, Tan Tock Seng Hospital Rehabilitation Centre, Singapore, Singapore.'}, {'ForeName': 'Chien Joo', 'Initials': 'CJ', 'LastName': 'Lim', 'Affiliation': 'Clinical Research & Innovation Office, Tan Tock Seng Hospital, Singapore, Singapore.'}, {'ForeName': 'Chuan Mien', 'Initials': 'CM', 'LastName': 'Hoo', 'Affiliation': 'School of Engineering, Ngee Ann Polytechnic, Singapore, Singapore.'}, {'ForeName': 'Kuang Chua', 'Initials': 'KC', 'LastName': 'Chua', 'Affiliation': 'School of Engineering, Ngee Ann Polytechnic, Singapore, Singapore.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Chee', 'Affiliation': 'School of Engineering, Ngee Ann Polytechnic, Singapore, Singapore.'}, {'ForeName': 'Wai Sing', 'Initials': 'WS', 'LastName': 'Ong', 'Affiliation': 'School of Engineering, Ngee Ann Polytechnic, Singapore, Singapore.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'School of Engineering, Ngee Ann Polytechnic, Singapore, Singapore.'}, {'ForeName': 'Chin Jung', 'Initials': 'CJ', 'LastName': 'Wong', 'Affiliation': 'Department of Rehabilitation Medicine, Centre of Advanced Rehabilitation Therapeutics, Tan Tock Seng Hospital Rehabilitation Centre, Singapore, Singapore.'}]",Frontiers in neurology,['10.3389/fneur.2020.00747']
2375,32793301,Using the GHQ-12 to screen for mental health problems among primary care patients: psychometrics and practical considerations.,"Background


This study explores the factor structure of the Indonesian version of the GHQ-12 based on several theoretical perspectives and determines the threshold for optimum sensitivity and specificity. Through a focus group discussion, we evaluate the practicality of the GHQ-12 as a screening tool for mental health problems among adult primary care patients in Indonesia.
Methods


This is a prospective study exploring the construct validity, criterion validity and reliability of the GHQ-12, conducted with 676 primary care patients attending 28 primary care clinics randomised for participation in the study. Participants' GHQ-12 scores were compared with their psychiatric diagnosis based on face-to-face clinical interviews with GPs using the CIS-R. Exploratory and Confirmatory Factor Analyses determined the construct validity of the GHQ-12 in this population. The appropriate threshold score of the GHQ-12 as a screening tool in primary care was determined using the receiver operating curve. Prior to data collection, a focus group discussion was held with research assistants who piloted the screening procedure, GPs, and a psychiatrist, to evaluate the practicality of embedding screening within the routine clinic procedures.
Results


Of all primary care patients attending the clinics during the recruitment period, 26.7% agreed to participate (676/2532 consecutive patients approached). Their median age was 46 (range 18-82 years); 67% were women. The median GHQ-12 score for our primary care sample was 2, with an interquartile range of 4. The internal consistency of the GHQ-12 was good (Cronbach's α = 0.76). Four factor structures were fitted on the data. The GHQ-12 was found to best fit a one-dimensional model, when response bias is taken into consideration. Results from the ROC curve indicated that the GHQ-12 is 'fairly accurate' when discriminating primary care patients with indication of mental disorders from those without, with average AUC of 0.78. The optimal threshold of the GHQ-12 was either 1/2 or 2/3 point depending on the intended utility, with a Positive Predictive Value of 0.68 to 0.73 respectively. The screening procedure was successfully embedded into routine patient flow in the 28 clinics.
Conclusions


The Indonesian version of the GHQ-12 could be used to screen primary care patients at high risk of mental disorders although with significant false positives if reasonable sensitivity is to be achieved. While it involves additional administrative burden, screening may help identify future users of mental health services in primary care that the country is currently expanding.",2020,"The GHQ-12 was found to best fit a one-dimensional model, when response bias is taken into consideration.","['adult primary care patients in Indonesia', '676 primary care patients attending 28 primary care clinics randomised for participation in the study', 'Their median age was 46', 'primary care patients', 'primary care patients attending the clinics during the recruitment period, 26.7% agreed to participate (676/2532 consecutive patients approached']",['GHQ-12'],"['median GHQ-12 score', 'GHQ-12 scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",676.0,0.017174,"The GHQ-12 was found to best fit a one-dimensional model, when response bias is taken into consideration.","[{'ForeName': 'S G', 'Initials': 'SG', 'LastName': 'Anjara', 'Affiliation': 'Cambridge Institute of Public Health, University of Cambridge, School of Clinical Medicine, Cambridge Biomedical Campus, Forvie Site, Robinson Way, Box 113, Cambridge, CB2 0SR UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bonetto', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Piazzale L.A. Scuro 10, 37134 Verona, Italy.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Van Bortel', 'Affiliation': 'Cambridge Institute of Public Health, University of Cambridge, School of Clinical Medicine, Cambridge Biomedical Campus, Forvie Site, Robinson Way, Box 113, Cambridge, CB2 0SR UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Brayne', 'Affiliation': 'Cambridge Institute of Public Health, University of Cambridge, School of Clinical Medicine, Cambridge Biomedical Campus, Forvie Site, Robinson Way, Box 113, Cambridge, CB2 0SR UK.'}]",International journal of mental health systems,['10.1186/s13033-020-00397-0']
2376,32793754,Comparison of the effect of electronic education and workshop on the satisfaction of nurses about Emergency Severity Index triage.,"INTRODUCTION


Nurse educators need to develop the level of scientific and practical of the students with the goal of becoming expert nurses. However, the use of modern educational methods to raise the motivation and satisfaction of learners can help individuals achieve this goal. Therefore, the aim of this study was to investigate the effect of health education in emergency nurses about triage.
METHODS


A two-group pool-blind experimental study was performed on seventy emergency nurses. Samples were randomly assigned into two groups: e-learning group (35 individuals = electronic education) and traditional group (35 = workshop education). The demographic questionnaire and the satisfaction questionnaire before and 2 weeks after the intervention in both groups were completed.
RESULTS


Independent  t -test showed that the satisfaction scores before intervention in both e-learning and traditional groups were not statistically significant, whereas there was a significant difference between two groups after 2 weeks after the intervention ( P  = 0/015).
CONCLUSION


Using nursing professors' electronic education programs can increase the level of satisfaction and motivation in the nursing mothers. Therefore, the use of this new educational method is recommended by managers and educational planners as an effective teaching.",2020,"Independent  t -test showed that the satisfaction scores before intervention in both e-learning and traditional groups were not statistically significant, whereas there was a significant difference between two groups after 2 weeks after the intervention ( P  = 0/015).
","['seventy emergency nurses', 'nursing mothers']","['electronic education and workshop', 'health education', 'e-learning group (35 individuals = electronic education) and traditional group (35 = workshop education']","['satisfaction scores', 'demographic questionnaire and the satisfaction questionnaire', 'level of satisfaction and motivation']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",70.0,0.0316878,"Independent  t -test showed that the satisfaction scores before intervention in both e-learning and traditional groups were not statistically significant, whereas there was a significant difference between two groups after 2 weeks after the intervention ( P  = 0/015).
","[{'ForeName': 'Ahmadreza', 'Initials': 'A', 'LastName': 'Yazdannik', 'Affiliation': 'Nursing and Midwifery Care Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Mohamadirizi', 'Affiliation': 'Nursing and Midwifery Care Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Nasr-Esfahani', 'Affiliation': 'Department of Emergency Medicine, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_182_19']
2377,32793757,The effect of educational intervention based on dramatic literature on parents of elementary schoolchildren skills in sex education.,"BACKGROUND


Today, one of the biggest concerns of parents is protecting their children and properly educating them about sex. The aim of this study was to determine the effect of educational intervention on parental skills in sex education on their children in elementary schools in the northwest of Tehran-Iran in 2019 based on literature.
MATERIALS AND METHODS


This quasi-experimental study was conducted on 125 parents of elementary schoolchildren in the northwestern of Tehran. The data were collected by valid and reliable questionnaire. Before the intervention, two intervention and control groups filled up the pretest questionnaire; the data were collected by valid and reliable questionnaire. Before the intervention, two intervention and control groups filled the pretest questionnaire, and then the parents participated in the educational program based on dramatic literature. Two months later, the same questionnaire was completed by the control and intervention groups. Finally, the data were analyzed by regression and one-way ANOVA test.
RESULTS


The results showed that there was a statistically significant difference between the mean scores of knowledge in the experimental and control groups in the posttest ( P  < 0.01). There was also a statistically significant difference between the mean scores of attitude in the experimental and control groups at the posttest stage ( P  < 0.01). There was also a statistically significant difference between the mean scores of performance based on group membership (experimental group and control group) in the posttest phase ( P  < 0.01).
CONCLUSIONS


The findings of the study showed that educational intervention on parental skills in sex education based on the dramatic literature to their children has significant effect on parental knowledge, attitude, and performance.",2020,There was also a statistically significant difference between the mean scores of attitude in the experimental and control groups at the posttest stage ( P  < 0.01).,"['125 parents of elementary schoolchildren in the northwestern of Tehran', 'sex education on their children in elementary schools in the northwest of Tehran-Iran in 2019 based on literature', 'parents of elementary schoolchildren skills in sex education']",['educational intervention'],"['mean scores of knowledge', 'parental knowledge, attitude, and performance', 'mean scores of performance', 'mean scores of attitude']","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0036879', 'cui_str': 'Sexuality education'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023866', 'cui_str': 'Literature'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.0131706,There was also a statistically significant difference between the mean scores of attitude in the experimental and control groups at the posttest stage ( P  < 0.01).,"[{'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Ghaffari', 'Affiliation': 'Health Promotion Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farbod Ebadi Fard', 'Initials': 'FEF', 'LastName': 'Azar', 'Affiliation': 'Health Promotion Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nammam Ali', 'Initials': 'NA', 'LastName': 'Azadi', 'Affiliation': 'Department of Biostatistics, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Mansourian', 'Affiliation': 'Health Management and Economics Research Center, Iran University of Medical Sciences, Tehran, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_537_19']
2378,32793773,Data on advanced glycation end-products concentrations and haemodynamic parameters following caffeine and nicotine consumption in nursing students.,"This work presents data from a non-invasive interventional trial investigating the early effects of caffeine and nicotine on both the concentrations of advanced glycation end-products (AGEs) and haemodynamic parameters in 178 healthy nursing students aged between 18 and 40. These students were allocated into four groups (A, B, C and D) and the concentrations of AGEs as well as haemodynamic parameters were measured non-invasively using the AgeReader and the Finometer devices, respectively. The haemodynamic parameters that were measured included systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, inter-beat interval, stroke volume, cardiac output, ventricular ejection time, total peripheral resistance, ascending aorta impedance and total arterial compliance. According to our protocol, each beverage contained 100 mg of caffeine each cigarette contained 1.5 mg of nicotine. The present data reveal the combined effect of smoke and caffeine consumption to several hemodynamic parameters that may be related to the onset of elevated blood pressure during smoking and following caffeine consumption.",2020,"These students were allocated into four groups (A, B, C and D) and the concentrations of AGEs as well as haemodynamic parameters were measured non-invasively using the AgeReader and the Finometer devices, respectively.","['nursing students', '178 healthy nursing students aged between 18 and 40']","['caffeine and nicotine', 'caffeine and nicotine consumption', 'caffeine each cigarette contained 1.5\u202fmg of nicotine']","['systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, inter-beat interval, stroke volume, cardiac output, ventricular ejection time, total peripheral resistance, ascending aorta impedance and total arterial compliance']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C2733340', 'cui_str': 'Ventricular ejection'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0003956', 'cui_str': 'Ascending aorta structure'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",178.0,0.0409427,"These students were allocated into four groups (A, B, C and D) and the concentrations of AGEs as well as haemodynamic parameters were measured non-invasively using the AgeReader and the Finometer devices, respectively.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Deltsidou', 'Affiliation': 'Midwifery Department, University of West Attica, Athens, Greece.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Zarikas', 'Affiliation': 'General Department, University of Thessaly, Greece.'}, {'ForeName': 'Dimos', 'Initials': 'D', 'LastName': 'Mastrogiannis', 'Affiliation': 'General Department, University of Thessaly, Lamia, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Kapreli', 'Affiliation': 'Physiotherapy Department, University of Thessaly, Lamia, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Bourdas', 'Affiliation': 'Second Chance School, Chania, Greece.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Raftopoulos', 'Affiliation': 'Hellenic National Public Health Organization, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Noula', 'Affiliation': 'Nursing Department, University of Nicosia, Nicosia, Cyprus.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Lykeridou', 'Affiliation': 'Midwifery Department, University of West Attica, Athens, Greece.'}]",Data in brief,['10.1016/j.dib.2020.106063']
2379,32790036,A randomized controlled trial of gaze-contingent music reward therapy for major depressive disorder.,"BACKGROUND


Heightened attention allocation toward negative-valanced information and reduced attention allocation toward positive-valanced information represent viable targets for attention bias modification in major depressive disorder. Accordingly, we conducted a randomized controlled trial testing the efficacy of a novel gaze-contingent attention bias modification procedure for major depressive disorder.
METHOD


Sixty patients with major depressive disorder were randomly assigned to either eight training sessions of feedback-based gaze-contingent music reward therapy designed to divert patients' gaze toward positive over sad stimuli, or to a control condition which entailed eight sessions of gaze-noncontingent music. Clinician-rated and self-reported measures of depression, and proportion of dwell-time on sad faces, were assessed pretreatment, posttreatment, and at a 3-month follow-up.
RESULTS


Gaze-contingent music reward therapy produced a greater reduction in dwell-time on sad faces compared with the control condition, but it failed to generalize to novel faces. Both groups manifested similarly significant reductions in depression symptoms from pre- to posttreatment that were maintained at follow-up. Exploratory analyses suggest that first-episode patients may benefit more from this therapy than patients with a history of multiple episodes.
CONCLUSIONS


Gaze-contingent music reward therapy can modify attention biases in depression, but clear differential clinical effects did not emerge. Theoretical and practical implications are discussed.",2020,"RESULTS


Gaze-contingent music reward therapy produced a greater reduction in dwell-time on sad faces compared with the control condition, but it failed to generalize to novel faces.","['Sixty patients with major depressive disorder', 'major depressive disorder']","['novel gaze-contingent attention bias modification procedure', 'Gaze-contingent music reward therapy', ""eight training sessions of feedback-based gaze-contingent music reward therapy designed to divert patients' gaze toward positive over sad stimuli, or to a control condition which entailed eight sessions of gaze-noncontingent music"", 'gaze-contingent music reward therapy']","['depression symptoms', 'depression, and proportion of dwell-time on sad faces', 'dwell-time on sad faces']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0429659', 'cui_str': 'Dwell time'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]",60.0,0.0492476,"RESULTS


Gaze-contingent music reward therapy produced a greater reduction in dwell-time on sad faces compared with the control condition, but it failed to generalize to novel faces.","[{'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Shamai-Leshem', 'Affiliation': 'Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Lazarov', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Pine', 'Affiliation': 'Section on Developmental Affective Neuroscience, National Institute of Mental Health, Bethesda, Maryland.'}, {'ForeName': 'Yair', 'Initials': 'Y', 'LastName': 'Bar-Haim', 'Affiliation': 'Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel.'}]",Depression and anxiety,['10.1002/da.23089']
2380,32790051,The effect of symptom-tracking apps on symptom reporting.,"OBJECTIVE


The use of health apps is increasing worldwide, with a common feature being daily symptom tracking. However, symptom tracking has been shown to increase symptom reporting. This study investigated whether using a menstrual-monitoring app with a symptom-tracking feature increases symptom reporting compared to an app without this feature or no app at all.
DESIGN


Experimental study.
METHODS


Ninety-one participants were randomly allocated to use either a menstrual-monitoring app with a symptom tracker or a simple calendar app, or to a no app control group. The number of period-related symptoms as well as general symptom reporting was assessed at baseline prior to group allocation and then 1 and 4 months later. The change in the proportion of people classified as high symptom reporters was also examined.
RESULTS


We found that the symptom-tracking app group reported significantly more period-related symptoms at 4 months than the calendar app group (mean difference = 1.16 symptoms, p = .010). At the 4-month time point, significantly more participants in the symptom-tracking group were now classified as high period symptom reporters (baseline 50%, 4 months 70%, p = .031), while the other two groups did not change from baseline. There were no differences in general symptom reporting across the three groups.
CONCLUSION


A period-monitoring app with a symptom tracker may increase the reporting of period symptoms. This effect does not appear to generalize to broader symptom reporting. Further research is needed to support these findings and to examine the impact of symptom-tracking apps on daily functioning and health anxiety. Statement of contribution What is already known on this subject? The experience of transient symptoms is common in day-to-day life. These symptoms often do not have an underlying cause or are a sign of illness. Actively tracking symptoms has been shown to result in greater symptom reporting, symptom severity, and slower recovery from injury. The use of health apps is increasing, with a common feature being symptom tracking. Menstrual-monitoring apps, in particular, frequently require users to track symptoms. What does this study add? Using a menstrual-monitoring app with a symptom tracker for 4 months increases the number of period-specific symptoms reported compared a basic calendar app. A greater proportion of people were now classified as high period symptom reporters after using the symptom-tracking app. These effects do not seem to generalize to broader non-specific symptom reporting.",2020,"We found that the symptom-tracking app group reported significantly more period-related symptoms at 4 months than the calendar app group (mean difference = 1.16 symptoms, p = .010).",['Ninety-one participants'],"['menstrual-monitoring app with a symptom tracker or a simple calendar app, or to a no app control group']","['number of period-related symptoms', 'number of period-specific symptoms', 'period-related symptoms', 'general symptom reporting']","[{'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C1516147', 'cui_str': 'Calendars'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449955', 'cui_str': 'Number of periods'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0159028', 'cui_str': 'General symptom'}]",91.0,0.0449667,"We found that the symptom-tracking app group reported significantly more period-related symptoms at 4 months than the calendar app group (mean difference = 1.16 symptoms, p = .010).","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'MacKrill', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, New Zealand.'}, {'ForeName': 'Katie M', 'Initials': 'KM', 'LastName': 'Groom', 'Affiliation': 'Liggins Institute, University of Auckland, New Zealand.'}, {'ForeName': 'Keith J', 'Initials': 'KJ', 'LastName': 'Petrie', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, New Zealand.'}]",British journal of health psychology,['10.1111/bjhp.12459']
2381,32790066,Clinical and Model-Based Evaluation of the Effect of Glasdegib on Cardiac Repolarization From a Randomized Thorough QT Study.,"Glasdegib is a potent, selective oral inhibitor of the Hedgehog signaling pathway. This phase 1 double-blind thorough QT study (NCT03162900) evaluated the effects of glasdegib on QTc interval. The study enrolled 36 healthy volunteers to receive a single dose of 150 mg glasdegib (representing a therapeutic dose), 300 mg glasdegib (representing a supratherapeutic dose), 400 mg moxifloxacin (positive control), or placebo under fasted conditions. The study demonstrated that therapeutic and supratherapeutic doses of glasdegib had no significant effect on QTc interval; the upper bound of the 2-sided 90% confidence intervals (CIs) for all time-matched least-squares mean differences in QT interval corrected using Fridericia's formula (QTcF) between glasdegib and placebo was below the prespecified criterion of 20 milliseconds (Food and Drug Administration correspondence reviewed and accepted). Based on an exposure-response analysis, glasdegib was determined not to have a meaningful effect on heart rate (change in RR interval). The mean (90%CI) model-derived baseline and placebo-adjusted QTcF at the average maximum observed concentration values corresponding to therapeutic and supratherapeutic glasdegib doses was 7.3 milliseconds (6.5-8.2 milliseconds) and 13.7 milliseconds (12.0-15.5 milliseconds), respectively. Together these results demonstrated that following therapeutic and supratherapeutic glasdegib dosing, the change in QTc from baseline was well below the 20-millisecond threshold of clinical concern in oncology.",2020,"Based on an exposure-response analysis, glasdegib was determined not to have a meaningful effect on heart rate (change in RR interval).",['36 healthy volunteers'],"['Glasdegib', 'moxifloxacin (positive control), or placebo', 'placebo']","['QTc interval', 'heart rate']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4519273', 'cui_str': 'glasdegib'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",36.0,0.114569,"Based on an exposure-response analysis, glasdegib was determined not to have a meaningful effect on heart rate (change in RR interval).","[{'ForeName': 'Joanna C', 'Initials': 'JC', 'LastName': 'Masters', 'Affiliation': 'Pfizer Inc., San Diego, California, USA.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Shaik', 'Affiliation': 'Pfizer Inc., San Diego, California, USA.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Mendes da Costa', 'Affiliation': 'Pfizer Inc., Brussels, Belgium.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hee', 'Affiliation': 'Pfizer Inc., Groton, Connecticut, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'LaBadie', 'Affiliation': 'Pfizer Inc., Groton, Connecticut, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.862']
2382,32790073,Post-operative opioid-related adverse events with intravenous oxycodone compared to morphine: a randomized controlled trial.,"BACKGROUND


The value of intravenous oxycodone compared to morphine remains controversial. The purpose of this trial was to compare opioid-related adverse events (ORAES) of intravenous oxycodone and morphine after total hip arthroplasty.
METHODS


Patients scheduled for total hip arthroplasty were enrolled in this study of postoperative pain treatment with intravenous oxycodone or intravenous morphine (ratio 1:1). After surgery, patients received similar drug regimens for titration in the postoperative care unit followed by intravenous patient-controlled analgesia (PCA). The primary outcome was the number of patients with ≥1 ORAEs within the first 24 hours defined as either nausea, vomiting, respiratory depression, pruritus, urinary retention requiring evacuation, allergy, hallucinations. Secondary outcomes included pain scores and opioid consumption.
RESULTS


The analysis included 238 patients with similar characteristics. There were 55 patients with at least one ORAEs in the oxycodone group versus 46 in the morphine group: 48% vs 40%, p=0.19; relative risk= 1.22 (0.91:1.63). Intravenous oxycodone vs intravenous morphine requirements were respectively (median, IQR): 6 (0-11) versus 8 (0-12) mg (p=0.06) for titration, 15 (8-26) vs 8 (5-16) mg (p=0.001) for PCA, and 22 (12-37) mg vs 19 (11-28) mg for cumulated intravenous consumption (p=0.048). During the first 24hr, there was no difference in secondary outcomes (oxycodone versus morphine, respectively, in %): nausea (15 vs 13), vomiting (5 vs 5), urinary retention (20 vs 12) or pain scores.
CONCLUSION


This study demonstrates that IV oxycodone did not significantly reduce ORAEs within the first 24 hours compared to similar ratio of IV morphine.",2020,This study demonstrates that IV oxycodone did not significantly reduce ORAEs within the first 24 hours compared to similar ratio of IV morphine.,"['238 patients with similar characteristics', 'Patients scheduled for total hip arthroplasty', 'after total hip arthroplasty']","['intravenous oxycodone or intravenous morphine (ratio 1:1', 'oxycodone and morphine', 'intravenous oxycodone', 'oxycodone', 'Intravenous oxycodone vs intravenous morphine', 'morphine']","['pain scores', 'number of patients with ≥1 ORAEs within the first 24\u2009hours defined as either nausea, vomiting, respiratory depression, pruritus, urinary retention requiring evacuation, allergy, hallucinations', 'pain scores and opioid consumption', 'ORAEs', 'vomiting', 'urinary retention', 'nausea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0018524', 'cui_str': 'Hallucinations'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",238.0,0.217499,This study demonstrates that IV oxycodone did not significantly reduce ORAEs within the first 24 hours compared to similar ratio of IV morphine.,"[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Cuvillon', 'Affiliation': 'Staff anesthesiologists, Department of Anaesthesiology and Pain Management, Centre Hospitalo-Universitaire (CHU) Carémeau, Place du Professeur Debré, Nîmes, and Montpellier University 1, Montpellier, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Alonso', 'Affiliation': 'Department of Biostatistics, Epidemiology, Public Health and and Methodological innovation (BESPIM), Nîmes University Hospital, University Montpellier 1, France.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': ""L'Hermite"", 'Affiliation': 'Staff anesthesiologists, Department of Anaesthesiology and Pain Management, Centre Hospitalo-Universitaire (CHU) Carémeau, Place du Professeur Debré, Nîmes, and Montpellier University 1, Montpellier, France.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Reubrecht', 'Affiliation': 'Staff Department of Anaesthesiology and Critical Care, CHU Pitié-Salpêtrière, Assistance Publique-Hôpitaux Paris (APHP), Sorbonne University, Paris.'}, {'ForeName': 'Lana', 'Initials': 'L', 'LastName': 'Zoric', 'Affiliation': 'Staff anesthesiologists, Department of Anaesthesiology and Pain Management, Centre Hospitalo-Universitaire (CHU) Carémeau, Place du Professeur Debré, Nîmes, and Montpellier University 1, Montpellier, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Vialles', 'Affiliation': 'Staff anesthesiologists, Department of Anaesthesiology and Pain Management, Centre Hospitalo-Universitaire (CHU) Carémeau, Place du Professeur Debré, Nîmes, and Montpellier University 1, Montpellier, France.'}, {'ForeName': 'Jean Luc', 'Initials': 'JL', 'LastName': 'Faillie', 'Affiliation': 'Department of Biostatistics, Epidemiology, Public Health and and Methodological innovation (BESPIM), Nîmes University Hospital, University Montpellier 1, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Kouyoumdjian', 'Affiliation': 'Department of Orthopedic surgery, Centre Hospitalo-Universitaire (CHU) Carémeau, , Place du Professeur Debré, Nîmes, and , Montpellier University 1, Montpellier, France.'}, {'ForeName': 'Christope', 'Initials': 'C', 'LastName': 'Boisson', 'Affiliation': 'Staff anesthesiologists, Department of Anaesthesiology and Pain Management, Centre Hospitalo-Universitaire (CHU) Carémeau, Place du Professeur Debré, Nîmes, and Montpellier University 1, Montpellier, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Raux', 'Affiliation': 'Professor of Anaesthesiology and Critical Care, Department of Anaesthesiology and Critical Care, CHU Pitié-Salpêtrière, APHP, Sorbonne University, Paris.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Langeron', 'Affiliation': 'Professor of Anaesthesiology and Critical Care, Department of Anaesthesiology and Critical Care, CHU Pitié-Salpêtrière, APHP, Sorbonne University, Paris.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13685']
2383,32790108,Differences in clinical characteristics and reported quality of life of men and women undergoing cardiac resynchronization therapy.,"AIMS


Response to cardiac resynchronization therapy (CRT) is known to be associated with a number of clinical characteristics, including QRS duration and morphology, gender, height, and the aetiology of heart failure (HF). We assessed the relation of gender and baseline characteristics with QRS duration and Kansas City Cardiomyopathy Questionnaire.
METHODS AND RESULTS


AdaptResponse is a global randomized trial. The trial enrolled CRT-indicated patients with New York Heart Association classes II-IV HF, left bundle branch block (QRS ≥ 140 ms in men, ≥130 ms in women), and baseline PR interval ≤200 ms. In total, 3620 patients were randomized, including 1569 women (43.3%) approaching the actual proportion of women in the HF population. Women were older and more often New York Heart Association class III or IV than men (55.6% vs. 48.7%), had less frequent ischaemic cardiomyopathy (21.2% vs. 39.5%), and had a 5.1 ms shorter QRS duration than men. Women were more often depressed (18.5% vs. 9.7%), had a significantly lower Kansas City Cardiomyopathy Questionnaire score, and had differences in medication prescriptions.
CONCLUSIONS


AdaptResponse is the largest randomized CRT trial and enrolled more women than any other landmark CRT trial. Women differed from men with regard to baseline characteristics and quality of life. Whether these differences translate into clinical outcome differences will be examined further in the AdaptResponse trial.",2020,"Women were more often depressed (18.5% vs. 9.7%), had a significantly lower Kansas City Cardiomyopathy Questionnaire score, and had differences in medication prescriptions.
","['men and women undergoing cardiac resynchronization therapy', '3620 patients were randomized, including 1569 women (43.3%) approaching the actual proportion of women in the HF population', 'patients with New York Heart Association classes II-IV HF, left bundle branch block (QRS\xa0≥\xa0140\xa0ms in men, ≥130\xa0ms in women), and baseline PR interval ≤200\xa0ms']",['cardiac resynchronization therapy (CRT'],"['quality of life', 'frequent ischaemic cardiomyopathy', 'Kansas City Cardiomyopathy Questionnaire score', 'QRS duration']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0023211', 'cui_str': 'Left bundle branch block'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0429087', 'cui_str': 'PR interval - finding'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0349782', 'cui_str': 'Generalized ischemic myocardial dysfunction'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0429025', 'cui_str': 'QRS complex duration'}]",3620.0,0.226255,"Women were more often depressed (18.5% vs. 9.7%), had a significantly lower Kansas City Cardiomyopathy Questionnaire score, and had differences in medication prescriptions.
","[{'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Wilkoff', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Birnie', 'Affiliation': 'University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Gold', 'Affiliation': 'Department of Cardiology, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Ahmad S', 'Initials': 'AS', 'LastName': 'Hersi', 'Affiliation': 'Faculty of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Jacobs', 'Affiliation': 'Medtronic Bakken Research Center, Maastricht, The Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Gerritse', 'Affiliation': 'Medtronic Bakken Research Center, Maastricht, The Netherlands.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Kusano', 'Affiliation': 'National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Leclercq', 'Affiliation': 'Department of Cardiology, University of Rennes, Rennes, France.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Mullens', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium and Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}]",ESC heart failure,['10.1002/ehf2.12914']
2384,32790196,Effects of Combination Denosumab and High-Dose Teriparatide Administration on Bone Microarchitecture and Estimated Strength: the DATA-HD HR-pQCT Study.,"In postmenopausal women at high risk of fracture, we previously reported that combined denosumab and high-dose (HD, 40-μg) teriparatide increased spine and hip bone mineral density (BMD) more than combination with standard-dose teriparatide (SD, 20-μg). To assess the effects of these combinations on bone microarchitecture and estimated bone strength, we performed high-resolution peripheral quantitative computed tomography (HR-pQCT) at the distal radius and distal tibia in these women, who were randomized to receive either teriparatide 20-ug (n=39) or 40-μg (n=37) during months 0-9 overlapped with denosumab 60-mg s.c. given at month 3 and 9, for a 15-month study duration. The 69 women who completed at least one study visit after baseline are included in this analysis. Over 15 months, increases in total BMD were higher in the HD-group than the SD-group at the distal tibia (5.3% vs. 3.4%, P=0.01) with a similar trend at the distal radius (2.6% vs. 1.0%, P=0.06). At 15 months, cortical porosity remained similar to baseline, with absolute differences of -0.1% and -0.7% at the distal tibia and -0.4% and -0.1% at the distal radius, in the HD-group and SD-group, respectively, P=NS for all comparisons. Tibial cortical tissue mineral density increased similarly in both treatment groups (1.3% (P<0.0001 vs. baseline) and 1.5% (P<0.0001 vs. baseline) in the HD-group and SD-group, respectively, P=0.75 for overall group difference). Improvements in trabecular microarchitecture at the distal tibia and estimated strength by micro-finite element analysis at both sites were numerically greater in the HD-group compared to SD-group, but not significantly so. Together, these findings suggest that short-term treatment combining denosumab with either high or standard-dose teriparatide improves HR-pQCT measures of bone density, microstructure, and estimated strength, with greater gains in total bone density observed in the HD-group, which may be of benefit in postmenopausal women with severe osteoporosis. This article is protected by copyright. All rights reserved.",2020,"Tibial cortical tissue mineral density increased similarly in both treatment groups (1.3% (P<0.0001 vs. baseline) and 1.5% (P<0.0001 vs. baseline) in the HD-group and SD-group, respectively, P=0.75 for overall group difference).","['69 women who completed at least one study visit after baseline are included in this analysis', 'postmenopausal women with severe osteoporosis', 'postmenopausal women at high risk of fracture']","['teriparatide 20-ug (n=39) or 40-μg (n=37) during months 0-9 overlapped with denosumab 60-mg s.c', 'Combination Denosumab and High-Dose Teriparatide']","['Tibial cortical tissue mineral density', 'total BMD', 'total bone density', 'spine and hip bone mineral density (BMD', 'HR-pQCT measures of bone density, microstructure, and estimated strength', 'cortical porosity', 'Bone Microarchitecture and Estimated Strength']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0185027', 'cui_str': 'Imbrication'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0412669', 'cui_str': 'Computerized tomography, bone density study'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0080037', 'cui_str': 'Porosity'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}]",69.0,0.0953027,"Tibial cortical tissue mineral density increased similarly in both treatment groups (1.3% (P<0.0001 vs. baseline) and 1.5% (P<0.0001 vs. baseline) in the HD-group and SD-group, respectively, P=0.75 for overall group difference).","[{'ForeName': 'Sabashini K', 'Initials': 'SK', 'LastName': 'Ramchand', 'Affiliation': 'Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Natalie L', 'Initials': 'NL', 'LastName': 'David', 'Affiliation': 'Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bruce', 'Affiliation': 'Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Bouxsein', 'Affiliation': 'Department of Orthopedic Surgery, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Benjamin Z', 'Initials': 'BZ', 'LastName': 'Leder', 'Affiliation': 'Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Joy N', 'Initials': 'JN', 'LastName': 'Tsai', 'Affiliation': 'Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Harvard University, Boston, MA, USA.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4161']
2385,32783498,"Primary school-based nutrition education intervention on nutrition knowledge, attitude and practices among school-age children in Ghana.","This study was performed to evaluate the effect of a six-week nutrition education intervention on the nutrition knowledge, attitude, practices, and nutrition status of school-age children (aged 6-12 years) in basic schools in Ghana. Short-term effects of nutrition education training sessions on teachers and caregivers were also assessed. Pre-post controlled design was used to evaluate the program. Intervention groups had significantly higher nutrition knowledge scores (8.8 ± 2.0 vs. 5.9 ± 2.1,  P  < 0.0001) compared to controls in the lower primary level. A higher proportion of children in the intervention group strongly agreed they enjoyed learning about food and nutrition issues compared to the control group (88% vs. 77%,  P  = 0.031). There was no significant difference in dietary diversity scores (4.8 ± 2.0 vs. 5.1 ± 1.4,  P  = 0.184) or in measured anthropometric indices (3.6% vs. 8.2%,  P  = 0.08). A marginally lower proportion of stunted schoolchildren was observed among the intervention group compared to the control group (3.6% vs. 8.2%,  P  = 0.080). Nutrition knowledge of teachers and caregivers significantly improved (12.5 ± 1.87 vs. 9.2 ± 2.1;  P  = 0.031) and (5.86 ± 0.73 to 6.24 ± 1.02,  P  = 0.009), respectively. Nutrition education intervention could have positive impacts on knowledge and attitudes of school children, and may be crucial in the development of healthy behaviors for improved nutrition status.",2020,"A marginally lower proportion of stunted schoolchildren was observed among the intervention group compared to the control group (3.6% vs. 8.2%,  P  = 0.080).","['school-age children in Ghana', 'school-age children (aged 6-12\u2009years) in basic schools in Ghana', 'school children']","['Nutrition education intervention', 'Primary school-based nutrition education intervention', 'six-week nutrition education intervention', 'nutrition education training sessions']","['dietary diversity scores', 'enjoyed learning about food and nutrition issues', 'anthropometric indices', 'nutrition knowledge, attitude and practices', 'nutrition knowledge scores', 'proportion of stunted schoolchildren']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0017516', 'cui_str': 'Ghana'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0260267', 'cui_str': 'School child'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.0270355,"A marginally lower proportion of stunted schoolchildren was observed among the intervention group compared to the control group (3.6% vs. 8.2%,  P  = 0.080).","[{'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Antwi', 'Affiliation': 'Department of Agriculture, Nutrition and Human Ecology, Prairie View A&M University, USA.'}, {'ForeName': 'Agartha', 'Initials': 'A', 'LastName': 'Ohemeng', 'Affiliation': 'Department of Nutrition and Food Science, University of Ghana.'}, {'ForeName': 'Laurene', 'Initials': 'L', 'LastName': 'Boateng', 'Affiliation': 'Department of Nutrition and Dietetics, University of Ghana.'}, {'ForeName': 'Esi', 'Initials': 'E', 'LastName': 'Quaidoo', 'Affiliation': 'Department of Nutrition and Food Science, University of Ghana.'}, {'ForeName': 'Boateng', 'Initials': 'B', 'LastName': 'Bannerman', 'Affiliation': 'Nutrition Linkages Project, University of Ghana.'}]",Global health promotion,['10.1177/1757975920945241']
2386,32783645,Comparing focused attention meditation to meditation with mobile neurofeedback for persistent symptoms after mild-moderate traumatic brain injury: a pilot study.,"PRIMARY OBJECTIVE


This study evaluated whether a meditation practice incorporating mobile neurofeedback (mNF) offers any advantage over a more traditional form of focused attention (FA) meditation in managing persistent symptoms after traumatic brain injury (TBI) (clinicaltrials.gov NCT02615535).
RESEARCH DESIGN


Pilot randomized clinical trial, exploring feasibility of mNF in TBI.
METHODS AND PROCEDURES


Participants included adults with chronic mood and/or cognitive complaints following mild-moderate TBI. Subjects practiced either FA (n = 10) or mNF (n = 10) meditation 12 minutes daily for 6 weeks. Pre-post intervention difference on the Neurobehavioral Symptom Inventory (NSI) was the primary outcome variable. Secondary outcomes included the Beck Anxiety Inventory (BAI), Beck Depression Inventory-II (BDI-II), amongst other scales and neurocognitive tests.
MAIN OUTCOMES AND RESULTS


No significant pre-post between-group differences were found on the NSI ( p  = .838) nor other assessments. In an exploratory analysis combining FA and mNF data, meditation was associated with significant improvements on the NSI ( p  = .04), BAI ( p  = .012) and BDI ( p  = .037).
CONCLUSIONS


Meditating with neurofeedback does not appear to provide an advantage over meditating on one's own for chronic post-TBI symptoms. Further research on home-based meditation following TBI, whether self-directed or technologically facilitated, is warranted.",2020,No significant pre-post between-group differences were found on the NSI ( p  = .838) nor other assessments.,"['persistent symptoms after mild-moderate traumatic brain injury', 'Participants included adults with chronic mood and/or cognitive complaints following mild-moderate TBI']","['attention meditation to meditation with mobile neurofeedback', 'mNF', 'meditation practice incorporating mobile neurofeedback (mNF', 'focused attention (FA) meditation', 'FA']","['Beck Anxiety Inventory (BAI), Beck Depression Inventory-II (BDI-II), amongst other scales and neurocognitive tests', 'BDI', 'Neurobehavioral Symptom Inventory (NSI', 'NSI', 'BAI']","[{'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0589098', 'cui_str': 'Focused attention'}]","[{'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0872227', 'cui_str': 'Neurocognitive Tests'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",,0.229317,No significant pre-post between-group differences were found on the NSI ( p  = .838) nor other assessments.,"[{'ForeName': 'Ginger', 'Initials': 'G', 'LastName': 'Polich', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital/Harvard Medical School , Charlestown, MA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gray', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital/Harvard Medical School , Charlestown, MA, USA.'}, {'ForeName': 'Duc', 'Initials': 'D', 'LastName': 'Tran', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Loma Linda University , Loma Linda, CA, USA.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Morales-Quezada', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital/Harvard Medical School , Charlestown, MA, USA.'}, {'ForeName': 'Mel', 'Initials': 'M', 'LastName': 'Glenn', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital/Harvard Medical School , Charlestown, MA, USA.'}]",Brain injury,['10.1080/02699052.2020.1802781']
2387,32783665,"Effect of Group Psychoeducation on Treatment Adherence, Quality of Life and Well-Being of Patients Diagnosed with Schizophrenia.","Psychoeducation offers a holistic approach that focuses on the philosophy of health, cooperation, coping and empowerment, but it is known that experimental studies used in psychoeducation in schizophrenia are insufficient. The study was conducted with 42 schizophrenia patients using a quasi-experimental research design. Patients were evaluated using a pretest, post-test, follow-up test, ""Medication Adherence Rating Scale"", ""Quality of Life Scale for Schizophrenia"" and ""Flourishing Scale"". There was a significant difference between the experimental group and the control group in terms of pretest and post-test, pretest and follow-up test scores (p < 0.05). The post-test and follow-up test scores of the patients in the experimental group were determined to increase their quality of life and well-being score (p < 0.05). This study is an important contribution to the literature due to its assessment of the relationship between psychoeducation and change in treatment adherence, quality of life and levels of well-being.",2020,"There was a significant difference between the experimental group and the control group in terms of pretest and post-test, pretest and follow-up test scores (p < 0.05).","['Patients Diagnosed with Schizophrenia', '42 schizophrenia patients using a quasi-experimental research design']",['Group Psychoeducation'],"['quality of life and well-being score', 'Medication Adherence Rating Scale"", ""Quality of Life Scale for Schizophrenia"" and ""Flourishing Scale', 'Treatment Adherence, Quality of Life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0035171', 'cui_str': 'Research Design'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}]",42.0,0.0179966,"There was a significant difference between the experimental group and the control group in terms of pretest and post-test, pretest and follow-up test scores (p < 0.05).","[{'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Kızılırmak Tatu', 'Affiliation': 'Faculty Department of Nursing, Gazi University Health Science, Ankara, Turkey.'}, {'ForeName': 'Satı', 'Initials': 'S', 'LastName': 'Demir', 'Affiliation': 'Faculty Department of Nursing, Gazi University Health Science, Ankara, Turkey.'}]",Issues in mental health nursing,['10.1080/01612840.2020.1793244']
2388,32783769,"Immunogenicity and safety of purified vero cell-cultured rabies vaccine under Zagreb 2-1-1 or 5-dose Essen regimen in the healthy Chinese subjects: a randomized, double-blind, positive controlled phase 3 clinical trial.","AIM


The aims of the study were to evaluate the non-inferiority of the safety and immunogenicity of a new trial purified vero cell-cultured rabies vaccine (trial vaccine) in healthy subjects comparing with the control purified vero cell-cultured rabies vaccine (control vaccine) following Essen regimen and to evaluate the non-inferiority of the safety and immunogenicity of the trial vaccine following two intramuscular regimens, between Zagreb and Essen regimen.  Methods : Serum samples were collected before vaccination and on d 7, 14, 35/42 post vaccination. Adverse events (AEs) were recorded for 30 d following each vaccination. This study was registered in the Chinese Clinical Trial Registry (ChiCTR-PPR-15007057).  Results : There was no significant difference in the incidence of AEs, local and systemic reactions, among Zagreb group, Essen group, and control group. But the incidence of solicited AEs was a significant difference among the three groups ( p  = 0.0498). The incidence of solicited AEs was higher in Essen group than that in control group and Zagreb group ( p  = 0.0278,  p  = 0.0248). In the subjects whose antibodies were seronegative before vaccination, the seroconversion rates of antibodies among three groups were all 100.0% on d 14 and d 35/42. The Essen group was not inferior to the control group, and the Zagreb group was not inferior to the Essen group on d 14. On d 14 and d 35/42, the geometric mean concentration of the three groups was much higher than the immune protection level of 0.5 IU/ml.  Conclusions : The trial vaccine had good safety and immunogenicity, and the trial vaccine is not inferior to the control vaccine.
ABBREVIATIONS


PVRV: purified vero cell-cultured rabies vaccine; AE: adverse event; CI: confidence interval; GMC: geometric mean concentration; IM: intramuscular; NIFDC: National Institutes for Food and Drug Control; PPS: per-protocol set; SS: safety set; REFIT: Rapid Fluorescent Focus Inhibition Test; RVNA: rabies virus neutralizing antibody; WHO: World Health Organization.",2020,"There was no significant difference in the incidence of AEs, local and systemic reactions, among Zagreb group, Essen group, and control group.","['healthy Chinese subjects', 'healthy subjects']","['new trial purified vero cell-cultured rabies vaccine (trial vaccine', 'control purified vero cell-cultured rabies vaccine (control vaccine', 'purified vero cell-cultured rabies vaccine', 'REFIT']","['geometric mean concentration', 'Adverse events (AEs', 'incidence of AEs, local and systemic reactions', 'good safety and immunogenicity', 'Immunogenicity and safety', 'incidence of solicited AEs', 'seroconversion rates of antibodies']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0042542', 'cui_str': 'Vero Cells'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",,0.170782,"There was no significant difference in the incidence of AEs, local and systemic reactions, among Zagreb group, Essen group, and control group.","[{'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Shen', 'Affiliation': 'Hubei Center for Disease Prevention and Control , Wuhan, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Hubei Center for Disease Prevention and Control , Wuhan, China.'}, {'ForeName': 'Beifang', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Hubei Center for Disease Prevention and Control , Wuhan, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Cai', 'Affiliation': 'Hubei Center for Disease Prevention and Control , Wuhan, China.'}, {'ForeName': 'Changjun', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Dangyang Center for Disease Prevention and Control , Dangyang, China.'}, {'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Xie', 'Affiliation': 'Tuanfeng Center for Disease Prevention and Control , Huanggang, China.'}, {'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': 'Dangyang Center for Disease Prevention and Control , Dangyang, China.'}, {'ForeName': 'Qunhui', 'Initials': 'Q', 'LastName': 'Ren', 'Affiliation': 'Dangyang Center for Disease Prevention and Control , Dangyang, China.'}, {'ForeName': 'Zhengxu', 'Initials': 'Z', 'LastName': 'Qi', 'Affiliation': 'Tuanfeng Center for Disease Prevention and Control , Huanggang, China.'}, {'ForeName': 'Jinghui', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Xianshengweike Biopharmaceutical Co., Ltd , Jiangsu, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Hubei Center for Disease Prevention and Control , Wuhan, China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Hubei Center for Disease Prevention and Control , Wuhan, China.'}, {'ForeName': 'Faxian', 'Initials': 'F', 'LastName': 'Zhan', 'Affiliation': 'Hubei Center for Disease Prevention and Control , Wuhan, China.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1778408']
2389,32783799,Baseline Characteristics of Study Participants in the Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT) Trial.,"Recurrent enteric infections and micronutrient deficiencies, including deficiencies in the tryptophan-kynurenine-niacin pathway, have been associated with environmental enteric dysfunction, potentially contributing to poor child growth and development. We are conducting a randomized, placebo-controlled, 2 × 2 factorial interventional trial in a rural population in Haydom, Tanzania, to determine the effect of 1) antimicrobials (azithromycin and nitazoxanide) and/or 2) nicotinamide, a niacin vitamer, on attained length at 18 months. Mother/infant dyads were enrolled within 14 days of the infant's birth from September 2017 to September 2018, with the follow-up to be completed in February 2020. Here, we describe the baseline characteristics of the study cohort, risk factors for low enrollment weight, and neonatal adverse events (AEs). Risk factors for a low enrollment weight included being a firstborn child (-0.54 difference in weight-for-age  z -score [WAZ] versus other children, 95% CI: -0.71, -0.37), lower socioeconomic status (-0.28, 95% CI: -0.43, -0.12 difference in WAZ), and birth during the preharvest season (November to March) (-0.22, 95% CI: -0.33, -0.11 difference in WAZ). The most common neonatal serious AEs were respiratory tract infections and neonatal sepsis (2.2 and 1.4 events per 100 child-months, respectively). The study cohort represents a high-risk population for whom interventions to improve child growth and development are urgently needed. Further analyses are needed to understand the persistent impacts of seasonal malnutrition and the interactions between seasonality, socioeconomic status, and the study interventions.",2020,"The most common neonatal serious AEs were respiratory tract infections and neonatal sepsis (2.2 and 1.4 events per 100 child-months, respectively).","[""Mother/infant dyads were enrolled within 14 days of the infant's birth from September 2017 to September 2018, with the follow-up to be completed in February 2020"", 'rural population in Haydom, Tanzania', 'Study Participants in the Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT) Trial']","['antimicrobials (azithromycin and nitazoxanide) and/or 2) nicotinamide, a niacin vitamer', 'placebo']","['lower socioeconomic status', 'respiratory tract infections and neonatal sepsis']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0035962', 'cui_str': 'Rural Population'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0068788', 'cui_str': 'nitazoxanide'}, {'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0456103', 'cui_str': 'Sepsis of the newborn'}]",,0.15935,"The most common neonatal serious AEs were respiratory tract infections and neonatal sepsis (2.2 and 1.4 events per 100 child-months, respectively).","[{'ForeName': 'Tarina C', 'Initials': 'TC', 'LastName': 'Parpia', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Elwood', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Scharf', 'Affiliation': 'Department of Pediatrics, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Joann M', 'Initials': 'JM', 'LastName': 'McDermid', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Anne W', 'Initials': 'AW', 'LastName': 'Wanjuhi', 'Affiliation': 'Department of Pediatrics, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Rogawski McQuade', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Gratz', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Erling', 'Initials': 'E', 'LastName': 'Svensen', 'Affiliation': 'Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Swann', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Donowitz', 'Affiliation': ""Division of Infectious Disease, Children's Hospital of Richmond at Virginia Commonwealth University, Richmond, Virginia.""}, {'ForeName': 'Samwel', 'Initials': 'S', 'LastName': 'Jatosh', 'Affiliation': 'Haydom Global Health Research Centre, Haydom Lutheran Hospital, Haydom, Tanzania.'}, {'ForeName': 'Siphael', 'Initials': 'S', 'LastName': 'Katengu', 'Affiliation': 'Haydom Global Health Research Centre, Haydom Lutheran Hospital, Haydom, Tanzania.'}, {'ForeName': 'Paschal', 'Initials': 'P', 'LastName': 'Mdoe', 'Affiliation': 'Haydom Global Health Research Centre, Haydom Lutheran Hospital, Haydom, Tanzania.'}, {'ForeName': 'Sokoine', 'Initials': 'S', 'LastName': 'Kivuyo', 'Affiliation': 'National Institute for Medical Research, Muhimbili Medical Research Centre, Dar es Salaam, Tanzania.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Houpt', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'DeBoer', 'Affiliation': 'Department of Pediatrics, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Estomih', 'Initials': 'E', 'LastName': 'Mduma', 'Affiliation': 'Haydom Global Health Research Centre, Haydom Lutheran Hospital, Haydom, Tanzania.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Platts-Mills', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0918']
2390,32784185,Effectiveness of Combining Organizational Alcohol Policy and Skills Training for Managers to Reduce Hazardous Alcohol Consumption in Swedish Workplaces: Study Protocol for a Cluster Randomized Study.,"BACKGROUND


High alcohol consumption poses risks to individual health and society. Previous alcohol interventions have mainly focused on high-risk consumers or young adults in school-based settings. Since the majority of the adult population is in the workforce, the workplace can be considered a favorable arena for implementing interventions.
OBJECTIVE


This protocol describes a project aimed at increasing knowledge of the effectiveness of combining the implementation of an organizational alcohol policy with skills training for managers as a workplace alcohol prevention program, by evaluating the intervention and exploring managers' perceptions of the intervention.
METHODS


Organizations with at least 100 employees were invited to take part in the project. A total of 11 organizations (744 managers and 11,761 employees) were included in the project. Data are collected through self-administered online surveys at baseline, 12 months, and 24 months. The primary outcome is managers' inclination to initiate an early alcohol intervention (eg, by initiating a dialogue) when concern regarding employees' hazardous alcohol consumption arises. The secondary outcomes of interest are managers' and employees' organizational alcohol policy knowledge and changes in alcohol consumption, as measured using the Alcohol Use Disorder Identification Test (AUDIT) score. A linear mixed-model framework will be used to model variability on different levels. Primary analysis will follow an intention-to-treat approach. Additionally, managers' responses from semistructured interviews will be analyzed using thematic analysis to explore managers' experiences regarding the prevention program.
RESULTS


This study is ongoing. The overall study start was on January 2018, and the study is planned to end in December 2020. Baseline and 12-month follow-up measurements have been collected.
CONCLUSIONS


This project is designed to evaluate the effectiveness of an alcohol prevention program regarding higher inclination to initiate early alcohol interventions after policy implementation and skills training among managers, compared to the usual practices in the workplace. The results from this study can contribute to increased knowledge about alcohol interventions and future prevention programs in the workplace.
TRIAL REGISTRATION


ISRCTN17250048; http://www.isrctn.com/ISRCTN17250048.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17145.",2020,"This project is designed to evaluate the effectiveness of an alcohol prevention program regarding higher inclination to initiate early alcohol interventions after policy implementation and skills training among managers, compared to the usual practices in the workplace.","['A total of 11 organizations (744 managers and 11,761 employees', 'Managers to Reduce Hazardous Alcohol Consumption in Swedish Workplaces', 'Organizations with at least 100 employees were invited to take part in the project']","['alcohol prevention program', 'Organizational Alcohol Policy and Skills Training']","[""managers' inclination to initiate an early alcohol intervention (eg, by initiating a dialogue) when concern regarding employees' hazardous alcohol consumption arises"", ""interest are managers' and employees' organizational alcohol policy knowledge and changes in alcohol consumption, as measured using the Alcohol Use Disorder Identification Test (AUDIT) score""]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0335141', 'cui_str': 'Manager'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0029246', 'cui_str': 'Organizations'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}]","[{'cui': 'C0335141', 'cui_str': 'Manager'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0332284', 'cui_str': 'Arising in'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0029246', 'cui_str': 'Organizations'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0343397,"This project is designed to evaluate the effectiveness of an alcohol prevention program regarding higher inclination to initiate early alcohol interventions after policy implementation and skills training among managers, compared to the usual practices in the workplace.","[{'ForeName': 'Devy Lysandra', 'Initials': 'DL', 'LastName': 'Elling', 'Affiliation': 'Department of Public Health Sciences, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychology, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Carlbring', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wennberg', 'Affiliation': 'Department of Public Health Sciences, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Sundqvist', 'Affiliation': 'Department of Public Health Sciences, Stockholm University, Stockholm, Sweden.'}]",JMIR research protocols,['10.2196/17145']
2391,32784188,Recruiting Adolescents With Chronic Fatigue Syndrome/Myalgic Encephalomyelitis to Internet-Delivered Therapy: Internal Pilot Within a Randomized Controlled Trial.,"BACKGROUND


Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) in adolescents is common and disabling. Teenagers in the United Kingdom are more likely to recover if they access specialist care, but most do not have access to a local specialist CFS/ME service. Delivering treatment remotely via the internet could improve access to treatment.
OBJECTIVE


This study aims to assess (1) the feasibility of recruitment and retention into a trial of internet-delivered specialist treatment for adolescents with CFS/ME and (2) the acceptability of trial processes and 2 web-based treatments (to inform continuation to full trial).
METHODS


This study is an internal pilot for the initial 12 months of a full randomized controlled trial (RCT), with integrated qualitative methods (analysis of recruitment consultations and participant and clinician interviews). Recruitment and treatment were delivered remotely from a specialist pediatric CFS/ME treatment service within a hospital in South West United Kingdom. Adolescents (aged 11-17 years) from across the United Kingdom with a diagnosis of CFS/ME and no access to local specialist treatment were referred by their general practitioner to the treatment center. Eligibility assessment and recruitment were conducted via remote methods (telephone and on the web), and participants were randomized (via a computer-automated system) to 1 of 2 web-based treatments. The trial intervention was Fatigue in Teenagers on the InterNET in the National Health Service, a web-based modular CFS/ME-specific cognitive behavioral therapy program (designed to be used by young people and their parents or caregivers) supported by individualized clinical psychologist electronic consultations (regular, scheduled therapeutic message exchanges between participants and therapist within the platform). The comparator was Skype-delivered activity management with a CFS/ME clinician (mainly a physiotherapist or occupational therapist). Both treatments were intended to last for up to 6 months. The primary outcomes were (1) the number of participants recruited (per out-of-area referrals received between November 1, 2016, to October 31, 2017) and the proportion providing 6-month outcome data (web-based self-report questionnaire assessing functioning) and (2) the qualitative outcomes indicating the acceptability of trial processes and treatments.
RESULTS


A total of 89 out of 150 (59.3% of potentially eligible referrals) young people and their parents or caregivers were recruited, with 75 out of 89 (84.2%) providing 6-month outcome data. Overall, web-based treatment was acceptable; however, participants and clinicians described both the advantages and disadvantages of remote methods. No serious adverse events were reported.
CONCLUSIONS


Recruiting young people (and their parents or caregivers) into an RCT of web-based treatment via remote methods is feasible and acceptable. Delivering specialist treatment at home via the internet is feasible and acceptable, although some families prefer to travel across the United Kingdom for face-to-face treatment.
TRIAL REGISTRATION


ISRCTN 18020851; http://www.isrctn.com/ISRCTN18020851.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1186/s13063-018-2500-3.",2020,"No serious adverse events were reported.
","['adolescents with CFS/ME and (2', 'A total of 89 out of 150 (59.3% of potentially eligible referrals) young people and their parents or caregivers were recruited, with 75 out of 89 (84.2%) providing 6-month outcome data', 'Adolescents (aged 11-17 years) from across the United Kingdom with a diagnosis of CFS/ME and no access to local specialist treatment were referred by their general practitioner to the treatment center', 'Teenagers on the InterNET in the National Health Service, a web-based modular CFS/ME-specific cognitive behavioral therapy program (designed to be used by young people and their parents or caregivers) supported by individualized clinical psychologist electronic consultations (regular, scheduled therapeutic message exchanges between participants and therapist within the platform']",['internet-delivered specialist treatment'],"['proportion providing 6-month outcome data (web-based self-report questionnaire assessing functioning) and (2) the qualitative outcomes indicating the acceptability of trial processes and treatments', 'serious adverse events']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0553514', 'cui_str': 'Referral source'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C1273517', 'cui_str': 'Used by'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0237412', 'cui_str': 'Clinical psychologist'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332285', 'cui_str': 'In'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.161872,"No serious adverse events were reported.
","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Anderson', 'Affiliation': 'Centre for Academic Child Health, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Roxanne', 'Initials': 'R', 'LastName': 'Parslow', 'Affiliation': 'Centre for Academic Child Health, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hollingworth', 'Affiliation': 'Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Mills', 'Affiliation': 'Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Beasant', 'Affiliation': 'Centre for Academic Child Health, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Gaunt', 'Affiliation': 'Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kessler', 'Affiliation': 'Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Macleod', 'Affiliation': 'Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Pywell', 'Affiliation': 'Advanced Computing Research Centre, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Kieren', 'Initials': 'K', 'LastName': 'Pitts', 'Affiliation': 'Research IT, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Price', 'Affiliation': 'Department of Computer Science, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Stallard', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Knoop', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centres, Amsterdam Public Health Research Institute, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Van de Putte', 'Affiliation': ""Department of Paediatrics, Wilhelmina Children's Hospital, University Medical Centre Utrecht, Utrecht, Netherlands.""}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Nijhof', 'Affiliation': ""Department of Paediatrics, Wilhelmina Children's Hospital, University Medical Centre Utrecht, Utrecht, Netherlands.""}, {'ForeName': 'Gijs', 'Initials': 'G', 'LastName': 'Bleijenberg', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Crawley', 'Affiliation': 'Centre for Academic Child Health, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}]",Journal of medical Internet research,['10.2196/17768']
2392,32784231,Effect of low-dose lidocaine on objective upper extremity strength and immediate pain relief following cervical interlaminar epidural injections: a double-blinded randomized controlled trial.,"BACKGROUND


Low-dose lidocaine is a common diluent for analgesia following cervical interlaminar epidural steroid injection (CIESI). Concerns with this practice exist. A single-arm cohort reported that 20% of patients develop postprocedural upper extremity weakness when using lidocaine as a diluent. Furthermore, a high-cervical spinal block with unintended intrathecal or subdural administration is possible.
OBJECTIVE


Determine if low-dose lidocaine as a diluent during CIESI causes clinically meaningful (1) upper extremity weakness and (2) immediate pain relief when compared with saline.
DESIGN


Double-blinded randomized control trial.
METHODS


Patients with cervical radicular pain scheduled for CIESI were enrolled. Participants received lidocaine (CIESI-L) or saline (CIESI-S) as a diluent for the epidural injectate. Myotomal strength was measured with dynamometry before and between 20 and 30 min after CIESI. Pre-pain and post-pain scores were obtained. Primary and secondary outcomes were post-CIESI weakness of ≥20% (minimal clinically important difference (MCID)) in  > 1 myotome and ≥50% pain reduction on the numerical scale.
RESULTS


120 participants (64 females (53%), mean age, 56 (SD 13.7) years) completed the study and were analyzed (CIESI-L n=60; CIESI-S n=60). There was no significant between-group difference in the proportion of participants with postprocedural weakness, CIESI-L 41.7% (95% CI, 29.8% to 54.5%), CIESL-S 50% (95% CI, 37.5% to 62.5%). Between-group comparison showed no significant difference in pain reduction, relative risk 1.53 (95% CI, 0.82 to 2.86).
CONCLUSION


Low-dose lidocaine as a diluent in CIESI does not significantly increase the risk of post-CIESI myotomal weakness when compared with saline, but also does not substantially increase the likelihood of immediate, meaningful pain relief.
TRIAL REGISTRATION DETAILS


ClinicalTrials.gov (NCT03127137); December 26, 2017.",2020,"Between-group comparison showed no significant difference in pain reduction, relative risk 1.53 (95% CI, 0.82 to 2.86).
","['Patients with cervical radicular pain scheduled for CIESI were enrolled', 'cervical interlaminar epidural injections', '120 participants (64 females (53%), mean age, 56 (SD 13.7) years) completed the study and were analyzed (CIESI-L n=60; CIESI-S n=60']","['low-dose lidocaine', 'lidocaine', 'lidocaine (CIESI-L) or saline (CIESI-S']","['pain reduction', 'post-CIESI weakness of ≥20% (minimal clinically important difference (MCID)) in  > 1 myotome and ≥50%\u2009pain reduction on the numerical scale', 'objective upper extremity strength and immediate pain relief', 'postprocedural upper extremity weakness', 'risk of post-CIESI myotomal weakness', 'Myotomal strength', 'likelihood of immediate, meaningful pain relief', 'pain and post-pain scores', 'proportion of participants with postprocedural weakness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4552559', 'cui_str': 'Cervical radicular pain'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0196394', 'cui_str': 'Epidural steroid injection'}, {'cui': 'C0021486', 'cui_str': 'Injections, Peridural'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0196394', 'cui_str': 'Epidural steroid injection'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0196394', 'cui_str': 'Epidural steroid injection'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C4277733', 'cui_str': 'Minimal Clinically Important Difference'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0231043', 'cui_str': 'Structure of myotome'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0751409', 'cui_str': 'Monoparesis - arm'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0444463', 'cui_str': 'Myotomal'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.725452,"Between-group comparison showed no significant difference in pain reduction, relative risk 1.53 (95% CI, 0.82 to 2.86).
","[{'ForeName': 'Zachary L', 'Initials': 'ZL', 'LastName': 'McCormick', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Department of Orthopedic Surgery, University of Utah Hospital, Salt Lake City, Utah, USA zmccormi@gmail.com.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Burnham', 'Affiliation': 'Physical Medicine and Rehabilitation, University of Utah Hospital, Salt Lake City, Utah, USA.'}, {'ForeName': 'Shellie', 'Initials': 'S', 'LastName': 'Cunningham', 'Affiliation': 'Physical Medicine and Rehabilitation, University of Utah Hospital, Salt Lake City, Utah, USA.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Kendall', 'Affiliation': 'Physical Medicine and Rehabilitation, University of Utah Hospital, Salt Lake City, Utah, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bougie', 'Affiliation': 'Department of Anesthesiology, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Teramoto', 'Affiliation': 'Physical Medicine and Rehabilitation, University of Utah Hospital, Salt Lake City, Utah, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Walega', 'Affiliation': 'Anesthesiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2020-101598']
2393,32784252,Factors promoting physical activity in women with fibromyalgia: a qualitative interview study.,"OBJECTIVES


To gain deeper knowledge of factors promoting physical activity in women with fibromyalgia.
DESIGN


A qualitative study based on semistructured in-depth individual interviews. Analysed using qualitative content analysis.
PARTICIPANTS


Fourteen women with fibromyalgia, age 38-65, recruited from a previous randomised controlled trial investigating the effects of person-centred progressive resistance exercise compared with relaxation therapy.
SETTING


Interviews were conducted in a hospital setting.
RESULTS


The analysis resulted in four categories:  a desire to be physically active, finding the proper level and creating proper conditions, managing pain  and  getting it done .
CONCLUSION


This study reveals several factors both personal and environmental, which promote the ability to be physically active when living with pain and other symptoms of fibromyalgia. The participants expressed that, although they had a desire to be physically active, they needed support and guidance from a professional with adequate knowledge to help them find the proper level of exercise. They also expressed a need for the professional to understand their preferences, and to use these preferences as a basis for creating the proper conditions, helping them learn to manage pain and supporting them in getting the exercise done.",2020,"They also expressed a need for the professional to understand their preferences, and to use these preferences as a basis for creating the proper conditions, helping them learn to manage pain and supporting them in getting the exercise done.","['women with fibromyalgia', 'Fourteen women with fibromyalgia, age 38-65', 'Interviews were conducted in a hospital setting']",['person-centred progressive resistance exercise compared with relaxation therapy'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}]",[],14.0,0.135076,"They also expressed a need for the professional to understand their preferences, and to use these preferences as a basis for creating the proper conditions, helping them learn to manage pain and supporting them in getting the exercise done.","[{'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Larsson', 'Affiliation': 'Institute of Neuroscience and Physiology, Section of Health and Rehabilitation, Physiotherapy, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden anette.e.larsson@vgregion.se.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Feldthusen', 'Affiliation': 'Institute of Neuroscience and Physiology, Section of Health and Rehabilitation, Physiotherapy, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Kaisa', 'Initials': 'K', 'LastName': 'Mannerkorpi', 'Affiliation': 'Institute of Neuroscience and Physiology, Section of Health and Rehabilitation, Physiotherapy, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",BMJ open,['10.1136/bmjopen-2019-031693']
2394,32794100,Effects of participatory art-based painting workshops in geriatric inpatients: results of a non-randomized open label trial.,"BACKGROUND


Art-based activities like painting workshops demonstrated health benefits in older individuals living in home care facilities. Few studies examined the effects of painting workshops in geriatric inpatients.
AIM


The study aims to examine whether the participation in painting workshops performed in patients admitted to a geriatric acute care ward reduced the number of medications taken daily, use of psychoactive medications, the length of stay and inhospital mortality.
METHODS


Based on a non-randomized open label trial, 79 inpatients who participated in painting workshops and 79 control inpatients were recruited in the geriatric acute care ward of the Jewish general hospital (Montreal, Quebec, Canada). Four outcomes were used: the number of medications taken daily and use of psychoactive medications the day of discharge to geriatric acute care ward, the length of hospital stay and inhospital mortality.
RESULTS


The participation in Painting workshops were associated with a lower number of medications taken daily at discharge (Coefficient of regression β =  - 1.35 with P = 0.001) and lower inhospital mortality (odd ratio (OR) = 0.09 with P = 0.031). No significant association was reported with use of psychoactive medications and length of stay.
CONCLUSION


The participation in painting workshops reduced the number of medications taken daily and incident inhospital mortality in geriatric inpatients admitted to a geriatric acute care ward, suggested a positive effect on health condition of this participatory art-based activity.",2020,"The participation in painting workshops reduced the number of medications taken daily and incident inhospital mortality in geriatric inpatients admitted to a geriatric acute care ward, suggested a positive effect on health condition of this participatory art-based activity.","['geriatric inpatients', '79 inpatients who participated in painting workshops and 79 control inpatients were recruited in the geriatric acute care ward of the Jewish general hospital (Montreal, Quebec, Canada', 'patients admitted to a geriatric acute care ward reduced the number of medications taken daily, use of psychoactive medications, the length of stay and inhospital mortality', 'older individuals living in home care facilities', 'geriatric inpatients admitted to a geriatric acute care']",['participatory art-based painting workshops'],"['number of medications taken daily and use of psychoactive medications the day of discharge to geriatric acute care ward, the length of hospital stay and inhospital mortality', 'psychoactive medications and length of stay', 'number of medications taken daily and incident inhospital mortality', 'inhospital mortality']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0030208', 'cui_str': 'Paintings'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0022422', 'cui_str': 'Judaism'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019855', 'cui_str': 'Services, Home Care'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030208', 'cui_str': 'Paintings'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}]",79.0,0.019703,"The participation in painting workshops reduced the number of medications taken daily and incident inhospital mortality in geriatric inpatients admitted to a geriatric acute care ward, suggested a positive effect on health condition of this participatory art-based activity.","[{'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Beauchet', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, Sir Mortimer B. Davis - Jewish General Hospital, McGill University, 3755 Chemin de la Côte-Sainte-Catherine, Montréal, QC, H3T 1E2, Canada. olivier.beauchet@mcgill.ca.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Lafleur', 'Affiliation': 'Centre of Excellence on Longevity of McGill Integrated University Health Network, Montreal, QC, Canada.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Remondière', 'Affiliation': 'Centre of Excellence on Longevity of McGill Integrated University Health Network, Montreal, QC, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Galery', 'Affiliation': 'Centre of Excellence on Longevity of McGill Integrated University Health Network, Montreal, QC, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Vilcocq', 'Affiliation': 'Centre of Excellence on Longevity of McGill Integrated University Health Network, Montreal, QC, Canada.'}, {'ForeName': 'Cyrille P', 'Initials': 'CP', 'LastName': 'Launay', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, Sir Mortimer B. Davis - Jewish General Hospital, McGill University, 3755 Chemin de la Côte-Sainte-Catherine, Montréal, QC, H3T 1E2, Canada.'}]",Aging clinical and experimental research,['10.1007/s40520-020-01675-0']
2395,32794125,Microbiota of Four Tissue Types in American Alligators (Alligator mississippiensis) Following Extended Dietary Selenomethionine Exposure.,"Selenium represents an essential trace nutrient that is necessary for biological functions. Deficiencies can induce disease, but excess can induce toxicity. Selenium deficiency is a major concern in underdeveloped countries, while also posing as a toxic pollutant in waterways surrounding landfills, agricultural areas, and fossil fuel production sites. We examined the microbiome of selenomethionine (SeMet) fed American alligators (Alligator mississippiensis) at the beginning and end of a 7-week exposure experiment. Alligators were randomly divided into three groups: control and 1000 or 2000 ppm SeMet. DNA from before exposure (oral and cloaca swabs) and post-exposure (oral, cloaca, small & large intestines) sampling were extracted and amplified for bacterial 16 s rRNA. While treatment did not seem to have much effect, we observed a predominance of Fusobacteriaceae and Porpyromonodaceae across all tissue types. Cetobacterium and Clostridium are the most abundant genera as potential indicators of the aquatic and carrion feeding lifestyle of alligators.",2020,"While treatment did not seem to have much effect, we observed a predominance of Fusobacteriaceae and Porpyromonodaceae across all tissue types.",['Microbiota of Four Tissue Types in American Alligators (Alligator mississippiensis'],"['Selenium', 'control and 1000 or 2000\xa0ppm SeMet', 'selenomethionine (SeMet) fed American alligators (Alligator mississippiensis']",[],"[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0019633', 'cui_str': 'Tissue Typing'}, {'cui': 'C0327167', 'cui_str': 'Alligator mississippiensis'}]","[{'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0034616', 'cui_str': 'Selenomethionine Se 75'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0327167', 'cui_str': 'Alligator mississippiensis'}]",[],,0.0130584,"While treatment did not seem to have much effect, we observed a predominance of Fusobacteriaceae and Porpyromonodaceae across all tissue types.","[{'ForeName': 'Troy J', 'Initials': 'TJ', 'LastName': 'Kieran', 'Affiliation': 'Department of Environmental Health Science, University of Georgia, Athens, GA, 30602, USA.'}, {'ForeName': 'Samantha J', 'Initials': 'SJ', 'LastName': 'Goodman', 'Affiliation': 'Department of Poultry Science, University of Georgia, 30602, Athens, GA, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Finger', 'Affiliation': 'Department of Environmental Health Science, University of Georgia, Athens, GA, 30602, USA.'}, {'ForeName': 'Jesse C', 'Initials': 'JC', 'LastName': 'Thomas', 'Affiliation': 'Department of Environmental Health Science, University of Georgia, Athens, GA, 30602, USA.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Hamilton', 'Affiliation': 'Savannah River Ecology Laboratory, University of Georgia, 29802, Aiken, SC, USA.'}, {'ForeName': 'Tracey D', 'Initials': 'TD', 'LastName': 'Tuberville', 'Affiliation': 'Savannah River Ecology Laboratory, University of Georgia, 29802, Aiken, SC, USA.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Glenn', 'Affiliation': 'Department of Environmental Health Science, University of Georgia, Athens, GA, 30602, USA. travisg@uga.edu.'}]",Bulletin of environmental contamination and toxicology,['10.1007/s00128-020-02961-3']
2396,32794176,Lung volume changes in Apnoeic Oxygenation using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) compared to mechanical ventilation in adults undergoing laryngeal surgery.,"BACKGROUND


Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) using high flow 100% oxygen during apnoea has gained increased use during difficult airway management and laryngeal surgery due to a slower carbon dioxide rise compared to traditional apnoeic oxygenation. We have previously demonstrated high arterial oxygen partial pressures and an increasing arterial-alveolar carbon dioxide difference during THRIVE. Primary aim of this study was to characterise lung volume changes measured with electrical impedance tomography during THRIVE compared to mechanical ventilation.
METHODS


Thirty adult patients undergoing laryngeal surgery under general anaesthesia were randomised to THRIVE or mechanical ventilation. Subjects were monitored with electrical impedance tomography and repeated blood gas measurement perioperatively. The THRIVE group received 100% oxygen at 70 l min -1  during apnoea. The mechanical ventilation group was intubated and normoventilated with an FiO 2  of 0.4.
RESULTS


Mean age were 48.2 (19.9) and 51.3 (12.3) years, and BMI 26.0 (4.5) and 26.0 (3.9) in the THRIVE and mechanical ventilation group, respectively. Mean apnoea time in the THRIVE group was 17.9 (4.8) min. Mean apnoea to end-of-surgery time was 28.1 (12.8) min in the mechanical ventilation group. No difference in delta End Expiratory Lung Impedance was seen between groups over time. In the THRIVE group all but three subjects were well oxygenated during apnoea. THRIVE was discontinued for the three subjects that desaturated.
CONCLUSIONS


No difference in lung volume change over time, measured by electrical impedance tomography, was detected when using THRIVE compared to mechanical ventilation during laryngeal surgery.",2020,"No difference in lung volume change over time, measured by electrical impedance tomography, was detected when using THRIVE compared to mechanical ventilation during laryngeal surgery.","['adults undergoing laryngeal surgery', 'Thirty adult patients undergoing laryngeal surgery under general anaesthesia', 'Mean age were 48.2 (19.9) and 51.3 (12.3) years, and BMI 26.0 (4.5) and 26.0 (3.9) in the THRIVE and mechanical ventilation group, respectively']","['mechanical ventilation', 'THRIVE or mechanical ventilation', 'Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE', 'electrical impedance tomography and repeated blood gas measurement perioperatively']","['arterial oxygen partial pressures', 'arterial-alveolar carbon dioxide difference', 'Mean apnoea to end-of-surgery time', 'Mean apnoea time', 'delta End Expiratory Lung Impedance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191314', 'cui_str': '48.2'}, {'cui': 'C5191283', 'cui_str': '12.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}]","[{'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0442700', 'cui_str': 'End-expiration'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}]",30.0,0.0464048,"No difference in lung volume change over time, measured by electrical impedance tomography, was detected when using THRIVE compared to mechanical ventilation during laryngeal surgery.","[{'ForeName': 'Ida-Maria', 'Initials': 'IM', 'LastName': 'Forsberg', 'Affiliation': 'Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Ullman', 'Affiliation': 'Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Hoffman', 'Affiliation': 'At the time of the study, Medical School, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Lars I', 'Initials': 'LI', 'LastName': 'Eriksson', 'Affiliation': 'Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Åse', 'Initials': 'Å', 'LastName': 'Lodenius', 'Affiliation': 'Department of Physiology and Pharmacology, Section for Anesthesiology and Intensive Care Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Jonsson Fagerlund', 'Affiliation': 'Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13686']
2397,32794259,The Commensal Microbe Veillonella as a Marker for Response to an FGF19 Analog in Nonalcoholic Steatohepatitis.,"BACKGROUND & AIMS


The composition of the human gut microbiota is linked to health and disease, and knowledge of the impact of therapeutics on the microbiota is essential to decipher their biological roles and to gain new mechanistic insights. Here we report the effect of aldafermin, an analog of the gut hormone FGF19, versus placebo on the gut microbiota in a prospective, phase 2 study in patients with NASH.
APPROACH & RESULTS


176 patients with biopsy-confirmed NASH (NAS ≥4), fibrosis (F1-F3 by NASH CRN criteria) and elevated liver fat content (≥8% by MRI-PDFF) received 0.3 mg (n=23), 1 mg (n=49), 3 mg (n=49), 6 mg (n=28) aldafermin or placebo (n=27) for 12 weeks. Stool samples were collected on day 1 and week 12 and profiled using 16S rRNA gene sequencing; 122 patients had paired stool microbiome profiles at both day 1 and week 12. Overall, the state of the gut microbial community was distinctly stable in patients treated with aldafermin, with all major phyla and genera unaltered during therapy. Patients treated with aldafermin showed a significant, dose-dependent enrichment in the rare genus Veillonella, a commensal microbe known to have lactate-degrading and performance-enhancing properties, which correlated with changes in serum bile acid profile.
CONCLUSIONS


Veillonella may be a bile acid-sensitive bacteria whose enrichment is enabled by aldafermin-mediated suppression of bile acid synthesis and in particular, decreases in toxic bile acids. This study provides an integrated analysis of gut microbiome, serum bile acid metabolome, imaging and histological measurements in clinical trials testing aldafermin for NASH. Our results reveal novel biology and provide better understanding of the intricacies of microbiome-host interactions.",2020,"Patients treated with aldafermin showed a significant, dose-dependent enrichment in the rare genus Veillonella, a commensal microbe known to have lactate-degrading and performance-enhancing properties, which correlated with changes in serum bile acid profile.
","['176 patients with biopsy-confirmed NASH (NAS ≥4), fibrosis (F1-F3 by NASH CRN criteria) and elevated liver fat content (≥8% by MRI-PDFF', 'patients with NASH']","['aldafermin', 'aldafermin or placebo', 'placebo']","['state of the gut microbial community', 'Stool samples']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0027446', 'cui_str': 'National Academy of Sciences (U.S.)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C4761214', 'cui_str': 'Magnetic resonance proton density fat fraction measurement'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C1550661', 'cui_str': 'Stool specimen'}]",176.0,0.0410101,"Patients treated with aldafermin showed a significant, dose-dependent enrichment in the rare genus Veillonella, a commensal microbe known to have lactate-degrading and performance-enhancing properties, which correlated with changes in serum bile acid profile.
","[{'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'NAFLD Research Center, University of California, San Diego, United States.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Ling', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, United States.'}, {'ForeName': 'Duy M', 'Initials': 'DM', 'LastName': 'Dinh', 'Affiliation': 'Diversigen, Houston, United States.'}, {'ForeName': 'Alex M', 'Initials': 'AM', 'LastName': 'DePaoli', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, United States.'}, {'ForeName': 'Hsiao D', 'Initials': 'HD', 'LastName': 'Lieu', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, United States.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'University of Oxford, London, United Kingdom.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Virginia Commonwealth University, Richmond, United States.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.31523']
2398,32794478,Methylprednisolone acetate injection with casting versus casting alone for the treatment of De-Quervain's Tenosynovitis: a randomized controlled trial.,"OBJECTIVE


To compare the success of treatment between thumb spica cast with ""methylprednisolone acetate injection"" versus thumb spica cast alone for the treatment of de Quervain's disease as functional outcomes, complications and patient compliance.
METHODS


A single blinded randomized controlled trial using a probability sampling technique was conducted from January 2014 to h February 2017at the Orthopaedic Unit II, King Edward Medical University / Mayo Hospital, Lahore. A total of 134 patients of both genders, between 30-60 years of age presented with wrist pain and diagnosed de Quervain's disease, were included in the study. Patients were randomly divided into two group by the computer allocation method. Patients in Group-A received thumb spica cast with methylprednisolone acetate and xylocaine injection while patients in Group-B were treated with thumb spica cast alone. The outcome variable was frequency of successful treatment which was noted and compared among the groups.
RESULTS


Amongst the total 134 patients, the age of the patients ranged from 30 to 60 years with a mean of 37.16±5.15 years. Most of the patients were aged between 30 40 years (78.8%) followed by 41-50 years (21.2%). There were 38 (28.4%) male and 96 (71.6%) female patients in the study group with a male to female ratio of 1:2.5. In group-A mean VAS and Quick DASH score before treatment and after the treatment was statistically significant (p-value <0.001). In group-B mean VAS and Quick DASH score before and after the treatment was also significant (p-value <0.001) ( Table-2).
CONCLUSIONS


The effectiveness of treatment was significantly higher in patients treated with thumb spica cast with methylprednisolone acetate injection as compared to thumb spica cast alone.",2020,In group-A mean VAS and Quick DASH score before treatment and after the treatment was statistically significant (p-value <0.001).,"['total 134 patients, the age of the patients ranged from 30 to 60 years with a mean of 37.16±5.15 years', ""De-Quervain's Tenosynovitis"", 'There were 38 (28.4%) male and 96 (71.6%) female patients in the study group with a male to female ratio of 1:2.5', 'January 2014 to h February 2017at the Orthopaedic Unit II, King Edward Medical University / Mayo Hospital, Lahore', 'patients were aged between 30 40 years (78.8%) followed by 41-50 years (21.2', ""134 patients of both genders, between 30-60 years of age presented with wrist pain and diagnosed de Quervain's disease, were included in the study""]","['methylprednisolone acetate injection"" versus thumb spica cast alone', 'probability sampling technique', 'Methylprednisolone acetate injection with casting versus casting alone', 'thumb spica cast alone', 'methylprednisolone acetate injection', 'thumb spica cast with methylprednisolone acetate and xylocaine injection']","['frequency of successful treatment', 'mean VAS and Quick DASH score']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0149870', 'cui_str': 'Radial styloid tenosynovitis'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0221785', 'cui_str': 'Pain in wrist'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0600901', 'cui_str': 'Methylprednisolone acetate'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0040067', 'cui_str': 'Thumb structure'}, {'cui': 'C1289821', 'cui_str': 'Spica cast'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0699094', 'cui_str': 'Xylocaine'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.046391,In group-A mean VAS and Quick DASH score before treatment and after the treatment was statistically significant (p-value <0.001).,"[{'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Akhtar', 'Affiliation': 'Department of Orthopaedic Surgery, King Edward Medical University, Lahore, Pakistan.'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Faraz Ul Hassan Shah Gillani', 'Affiliation': 'Department of Orthopedic Surgery, King Edward Medical University, Mayo Hospital, Lahore.'}, {'ForeName': 'Rana Dilawaiz', 'Initials': 'RD', 'LastName': 'Nadeem', 'Affiliation': 'Department of Orthopaedic Surgery, King Edward Medical University, Lahore, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Tasneem', 'Affiliation': 'Department of Orthopedic Surgery, King Edward Medical University / Mayo Hospital, Lahore, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.293180']
2399,32794480,"Effect of nursing led discharge instructions on improvement of post discharge care management in heart failure patients at tertiary care hospital of Karachi, Pakistan.","Objectives


To assess the impact of nursing discharge instructions on post-discharge care management in heart failure patients.
METHODS


The quasi- experimental non-randomized study was conducted at the National Institute of Cardiovascular Diseases, Karachi, from January to December 2017, and comprised in-patients suffering from heart failure. They were divided into two equal groups. In the intervention group, discharge instructions and written material was thoroughly given by the nurses other than routine existing instructions for effective post-discharge care management. The control group received discharged instructions under existing routine. Data was analysed using SPSS 21.
RESULTS


Of the 80 patients, there were 40(50%) in each group with no significant difference in terms of age, gender and education (p>0.05 each). Regarding awareness and control of the disease, adherence with medication and proper management of their illness, the intervention group had higher level of competency than the control group (p=0.001).
CONCLUSIONS


Provision of nursing interventions to educate the patient of heart failure during hospitalisation, on discharge, follow-up day and continuous guidance on telephone significantly improved the post-discharge care management of the patients.",2020,"Regarding awareness and control of the disease, adherence with medication and proper management of their illness, the intervention group had higher level of competency than the control group (p=0.001).
","['heart failure patients', '80 patients', 'heart failure patients at tertiary care hospital of Karachi, Pakistan', 'National Institute of Cardiovascular Diseases, Karachi, from January to December 2017, and comprised in-patients suffering from heart failure']","['nursing led discharge instructions', 'discharged instructions under existing routine', 'nursing discharge instructions']",[],"[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]",[],,0.0321335,"Regarding awareness and control of the disease, adherence with medication and proper management of their illness, the intervention group had higher level of competency than the control group (p=0.001).
","[{'ForeName': 'Zafar', 'Initials': 'Z', 'LastName': 'Iqbal', 'Affiliation': 'Jinnah Medical and Dental College Hospital, Karachi, Pakistan.'}, {'ForeName': 'Munnaza', 'Initials': 'M', 'LastName': 'Parveen', 'Affiliation': 'Jinnah College of Nursing, Karachi, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Azhar', 'Affiliation': 'Lahore School of Nursing, The University of Lahore, Lahore, Pakistan.'}, {'ForeName': 'Mussarat', 'Initials': 'M', 'LastName': 'Parveen', 'Affiliation': 'Federal Government Public School Cantt. Garrision, Karachi, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Afzal', 'Affiliation': 'Lahore School of Nursing, The University of Lahore, Lahore, Pakistan.'}, {'ForeName': 'Muhammad Fayyaz', 'Initials': 'MF', 'LastName': 'Awan', 'Affiliation': 'Jinnah College of Nursing, Karachi, Pakistan.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Dow University of Health Sciences, Karachi, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.10911']
2400,32794481,Comparison of Cyriax manipulation with traditional physical therapy for the management of cervical discogenic problems. A randomized control trial.,"OBJECTIVE


To determine and compare the clinical outcome of Cyriax manipulation and traditional physical therapy for the treatment of cervical discogenic problems in terms of pain, range of motion and disability.
METHODS


The randomised controlled trial was conducted at Benazir Bhutto Hospital, Rawalpindi, Pakistan, from January to June, 2018, and comprised patients having prolapsed intervertebral disc with neck or arm pain who were then randomly allocated into control and experimental groups using the sealed envelope method. The control group received cervical isometrics 10 repetitions ×1 set, 4 days/week and targeted muscle strechings 10 repetition × 1 set/day for 4 days/week. The experimental group received 10 min pre-manipulative massage and Cyriax manipulation protocol. Data was analysed using SPSS 20.
RESULTS


Of the 40 subjects, there were 20(50%) in each of the two groups. The experimental group showed significance difference in terms of numeric pain rating scale, range of motion and the neck disability index (p<0.05 each).
CONCLUSIONS


Cyriax manipulation was found to be significantly better than the traditional treatment of physiotherapy for cervical discogenic pain.",2020,"The experimental group showed significance difference in terms of numeric pain rating scale, range of motion and the neck disability index (p<0.05 each).
","['Benazir Bhutto Hospital, Rawalpindi, Pakistan, from January to June, 2018, and comprised patients having prolapsed intervertebral disc with neck or arm pain who', 'cervical discogenic problems', '40 subjects']","['Cyriax manipulation with traditional physical therapy', '10 min pre-manipulative massage and Cyriax manipulation protocol', 'Cyriax manipulation and traditional physical therapy']","['numeric pain rating scale, range of motion and the neck disability index (p<0.05 each', 'pain, range of motion and disability']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0242362', 'cui_str': 'Intervertebral disc prolapse'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0239377', 'cui_str': 'Pain in upper limb'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]","[{'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0550383,"The experimental group showed significance difference in terms of numeric pain rating scale, range of motion and the neck disability index (p<0.05 each).
","[{'ForeName': 'Aisha', 'Initials': 'A', 'LastName': 'Razzaq', 'Affiliation': 'Riphah College of Rehabilitation Sciences, Riphah International university Islamabad, Pakistan.'}, {'ForeName': 'Abdul Ghafoor', 'Initials': 'AG', 'LastName': 'Sajjad', 'Affiliation': 'Faculty of Health and Medical Sciences, Riphah College of Rehabilitation Sciences, Riphah International University, Islamabad, Pakistan.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Yasin', 'Affiliation': 'THQ, Pindi, Bhattian, Punjab, Pakistan.'}, {'ForeName': 'Ramsha', 'Initials': 'R', 'LastName': 'Tariq', 'Affiliation': 'Railway General Hospital, Rawalpindi, Pakistan.'}, {'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Ashraf', 'Affiliation': 'Sharif Medical and Surgical Complex, Sahiwal, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.13250']
2401,32794482,Addition of bismuth to standard triple therapy for Helicobacter pylori eradication: a randomised controlled trial.,"OBJECTIVE


To compare the effect of addition of bismuth to the standard triple therapy for eradication of Helicobacter pylori (H. pylori) in a randomised controlled trial.
METHODS


The study was performed from June 2018-May 2019, in the two outpatient departments located at two different campuses of Ziauddin university hospitals (ZUH) Karachi. Ethical approval was obtained from the Ethics Review Committee of ZUH. It was designed as a randomized control trial in a parallel fashion. Arm A received triple therapy including amoxicillin, clarithromycin, and omeprazole for two weeks and Arm B received quadruple therapy adding colloidal bismuth subcitrate to the triple therapy. A stool antigen test was done six weeks post treatment to confirm H. pylori eradication.
RESULTS


A total of 196 participants were included, out of which 102(52%) were males and 94 (48%) were females. Among the patients receiving quadruple therapy, 92/98(93.8%) had negative posttreatment stool antigen results, while among triple therapy recipients 83/98 (84.6%) had negative stool antigen results, according to intention-to-treat analysis (p value=0.038; odds ratio 2.77, 95% CI 1.03-7.47). However, p-value changed to 0.082 (odds ratio 2.40, 95% CI 0.87-6.60) in per-protocol analysis as stool antigen results were not available in two patients in the triple therapy arm. No difference in the side-effect profiles of either arm was noted.
CONCLUSIONS


Eradication rates of H. pylori may be modestly improved by addition of bismuth to the standard triple therapy.
Clinical Trial Number


03968302 (clinicaltrials.gov).",2020,"Among the patients receiving quadruple therapy, 92/98(93.8%) had negative posttreatment stool antigen results, while among triple therapy recipients 83/98 (84.6%) had negative stool antigen results, according to intention-to-treat analysis (p value=0.038; odds ratio 2.77, 95% CI 1.03-7.47).","['June 2018-May 2019, in the two outpatient departments located at two different campuses of Ziauddin university hospitals (ZUH) Karachi', 'A total of 196 participants were included, out of which 102(52%) were males and 94 (48%) were females']","['bismuth to standard triple therapy', 'bismuth', 'amoxicillin, clarithromycin, and omeprazole']","['negative posttreatment stool antigen results', 'Helicobacter pylori eradication', 'negative stool antigen results']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}]",196.0,0.357975,"Among the patients receiving quadruple therapy, 92/98(93.8%) had negative posttreatment stool antigen results, while among triple therapy recipients 83/98 (84.6%) had negative stool antigen results, according to intention-to-treat analysis (p value=0.038; odds ratio 2.77, 95% CI 1.03-7.47).","[{'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Asim', 'Affiliation': 'Department of Gastroenterology, Ziauddin University Hospital, Karachi, Pakistan.'}, {'ForeName': 'Khurram', 'Initials': 'K', 'LastName': 'Baqai', 'Affiliation': 'Department of Gastroenterology, Ziauddin University Hospital, Karachi, Pakistan.'}, {'ForeName': 'Zaigham', 'Initials': 'Z', 'LastName': 'Abbas', 'Affiliation': 'Department of Gastroenterology, Ziauddin University Hospital, Karachi, Pakistan.'}, {'ForeName': 'Nasir', 'Initials': 'N', 'LastName': 'Laique', 'Affiliation': 'Department of Gastroenterology, Ziauddin University Hospital, Karachi, Pakistan.'}, {'ForeName': 'Shoukat Ali', 'Initials': 'SA', 'LastName': 'Samejo', 'Affiliation': 'Department of Gastroenterology, Ziauddin University Hospital, Karachi, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.55396']
2402,32790451,Mobile enhancement of motivation in schizophrenia: A pilot randomized controlled trial of a personalized text message intervention for motivation deficits.,"OBJECTIVE


Motivation deficits remain an unmet treatment need in schizophrenia. Recent research has identified mechanisms underlying motivation deficits (i.e., impaired effort-cost computations, reduced future reward-value representation maintenance) that may be effective treatment targets to improve motivation. This study tested the feasibility and preliminary effectiveness of Mobile Enhancement of Motivation in Schizophrenia (MEMS), an intervention that leverages mobile technology to target these mechanisms with text messages.
METHOD


Fifty-six participants with a schizophrenia-spectrum disorder were randomized to MEMS (n = 27) or a control condition (n = 29). All participants set recovery goals to complete over 8 weeks. Participants in the MEMS group additionally received personalized, interactive text messages on their personal cellphones each weekday.
RESULTS


Retention and engagement in MEMS were high: 92.6% completed 8 weeks of MEMS, with an 86.1% text message response rate, and 100% reported being satisfied with the text messages. Compared to participants in the control condition, the participants in the MEMS condition had significantly greater improvements in interviewer-rated motivation and anticipatory pleasure and attained significantly more recovery-oriented goals at 8 weeks. There were no significant group differences in purported mechanisms (performance-based effort-cost computations and future reward-value representations) or in self-reported motivation, quality of life, or functioning.
CONCLUSION


Results demonstrate that MEMS is feasible as a brief, low-intensity mobile intervention that could effectively improve some aspects of motivation (i.e., initiation and maintenance of goal-directed behaviors) and recovery goal attainment for those with schizophrenia-spectrum disorders. More work is needed with larger samples and to understand the mechanisms of change in MEMS. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Compared to participants in the control condition, the participants in the MEMS condition had significantly greater improvements in interviewer-rated motivation and anticipatory pleasure and attained significantly more recovery-oriented goals at 8 weeks.","['schizophrenia', 'Fifty-six participants with a schizophrenia-spectrum disorder']","['Mobile Enhancement of Motivation in Schizophrenia (MEMS', 'personalized text message intervention', 'MEMS', 'personalized, interactive text messages on their personal cellphones each weekday', 'control condition']","['Retention and engagement in MEMS', 'interviewer-rated motivation and anticipatory pleasure', 'purported mechanisms (performance-based effort-cost computations and future reward-value representations) or in self-reported motivation, quality of life, or functioning']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1136359', 'cui_str': 'Cellular Phone'}, {'cui': 'C1457900', 'cui_str': 'Each'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0021821', 'cui_str': 'Interviewers'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",56.0,0.174855,"Compared to participants in the control condition, the participants in the MEMS condition had significantly greater improvements in interviewer-rated motivation and anticipatory pleasure and attained significantly more recovery-oriented goals at 8 weeks.","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Luther', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital.'}, {'ForeName': 'Melanie W', 'Initials': 'MW', 'LastName': 'Fischer', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis.'}, {'ForeName': 'Annalee V', 'Initials': 'AV', 'LastName': 'Johnson-Kwochka', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis.'}, {'ForeName': 'Kyle S', 'Initials': 'KS', 'LastName': 'Minor', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Holden', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine.'}, {'ForeName': 'Chris L', 'Initials': 'CL', 'LastName': 'Lapish', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'McCormick', 'Affiliation': 'Department of Health and Rehabilitation Sciences in the College of Public Health, Temple University.'}, {'ForeName': 'Michelle P', 'Initials': 'MP', 'LastName': 'Salyers', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000599']
2403,32790453,Internet-based self-help for psychosis: Findings from a randomized controlled trial.,"OBJECTIVE


Cognitive-behavioral therapy (CBT) for psychosis is recommended in many national guidelines, but dissemination into routine health care remains poor. This study tests whether an 8-week, CBT-oriented, Internet-based intervention (IBI) for people with psychosis is feasible, effective, and safe compared to care as usual.
METHOD


A sample of 101 people diagnosed with schizophrenia-spectrum disorders (age: M = 40.0, SD = 9.60; sex: 58% female) was randomly assigned to either an IBI for psychosis or a wait-list control condition. The primary outcome was a composite score of the positive factor of the Positive and Negative Syndrome Scale, the Launay Slade Hallucination Scale, and the paranoia checklist (clinicaltrials.gov, NCT02974400).
RESULTS


The composite score of psychotic symptom severity decreased more in the IBI condition than in the wait-list condition, reflected in the significant interaction of Time × Condition, F(1, 87.28) = 4.04, p = .047, dbetween = 0.24, 95% CI [-0.15, 0.63]. In the combined sample of participants who received immediate or delayed access to the intervention, the outcome improved further during the 6-month follow up period with a significant main effect of time, F(1, 69.35) = 9.59, p = .003, d = -0.37, 95% CI [-0.66, -0.07]. Participants were satisfied with the intervention (89%), and many used the intervention as defined per protocol (52%; at least four completed modules). Adverse events were infrequent (4.9%).
CONCLUSIONS


Internet-based, CBT-oriented interventions provide an add-on effect to care as usual and have the potential to narrow the psychological treatment gap in psychosis. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"The composite score of psychotic symptom severity decreased more in the IBI condition than in the wait-list condition, reflected in the significant interaction of Time × Condition, F(1, 87.28) =","['people with psychosis', '101 people diagnosed with schizophrenia-spectrum disorders (age: M = 40.0, SD = 9.60; sex: 58% female']","['IBI for psychosis or a wait-list control condition', 'CBT-oriented, Internet-based intervention (IBI', 'Cognitive-behavioral therapy (CBT']","['composite score of psychotic symptom severity', 'Adverse events', 'composite score of the positive factor of the Positive and Negative Syndrome Scale, the Launay Slade Hallucination Scale, and the paranoia checklist (clinicaltrials.gov, NCT02974400']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0018524', 'cui_str': 'Hallucinations'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1456784', 'cui_str': 'Paranoid disorder'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",101.0,0.101073,"The composite score of psychotic symptom severity decreased more in the IBI condition than in the wait-list condition, reflected in the significant interaction of Time × Condition, F(1, 87.28) =","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Westermann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Rüegg', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern.'}, {'ForeName': 'Thies', 'Initials': 'T', 'LastName': 'Lüdtke', 'Affiliation': 'Department of Psychology, UiT-The Arctic University of Norway.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000602']
2404,32790454,"Feasibility and acceptability of a single-session, videoconference-delivered group intervention for pain in multiple sclerosis.","OBJECTIVE


Chronic pain is one of the most common and interfering symptoms experienced by people with MS. There is an opportunity to shift the paradigm from interventions delivered after pain has become chronic to early, proactive interventions to alter the impact of MS-related pain. The purpose of this study was to develop and test a remotely delivered single-session group intervention to modify the pain trajectory for individuals with early MS. Research Method/Design: This was a single-center 2-group pilot randomized (1:1) controlled trial comparing a novel videoconference-delivered single-session pain intervention to a waitlist control. Participants were  N  = 27 adults who were diagnosed with MS in the preceding 36 months and who had moderate or worse pain. The study team developed the intervention to introduce pain coping and commonly used cognitive, behavioral, and acceptance-based approaches for adaptive coping. Participants completed outcome assessments on pain intensity, interference, and coping at pretreatment, posttreatment, and 3-months posttreatment.
RESULTS


Among participants in the treatment arm, the majority (54%) indicated satisfaction with treatment and all (100%) indicated continued use of strategies learned in the intervention. The 2 groups did not differ on any of the outcomes at any time point, and large standard deviations were found on most of the measures for both groups at all timepoints.
CONCLUSIONS/IMPLICATIONS


This brief, highly accessible intervention targeting pain coping in individuals with early MS is feasible and acceptable. Further research is needed to better understand the effectiveness of the intervention both immediately and in positively impacting future coping in this population. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"The 2 groups did not differ on any of the outcomes at any time point, and large standard deviations were found on most of the measures for both groups at all timepoints.
","['individuals with early MS', 'N  = 27 adults who were diagnosed with MS in the preceding 36 months and who had moderate or worse pain', 'Participants were', 'pain in multiple sclerosis']","['single-session, videoconference-delivered group intervention', 'novel videoconference-delivered single-session pain intervention']","['pain intensity, interference, and coping at pretreatment, posttreatment, and 3-months posttreatment', 'Feasibility and acceptability']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.073638,"The 2 groups did not differ on any of the outcomes at any time point, and large standard deviations were found on most of the measures for both groups at all timepoints.
","[{'ForeName': 'Kevin N', 'Initials': 'KN', 'LastName': 'Alschuler', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Altman', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Ehde', 'Affiliation': 'Department of Rehabilitation Medicine.'}]",Rehabilitation psychology,['10.1037/rep0000360']
2405,32790492,PARP Inhibitors in the Management of Ovarian Cancer: ASCO Guideline.,"PURPOSE


To provide recommendations on the use of poly(ADP-ribose) polymerase inhibitors (PARPis) for management of epithelial ovarian, tubal, or primary peritoneal cancer (EOC).
METHODS


Randomized, controlled, and open-labeled trials published from 2011 through 2020 were identified in a literature search. Guideline recommendations were based on the review of the evidence, US Food and Drug Administration approvals, and consensus when evidence was lacking.
RESULTS


The systematic review identified 17 eligible trials.
RECOMMENDATIONS


The guideline pertains to patients who are PARPi naïve. All patients with newly diagnosed, stage III-IV EOC whose disease is in complete or partial response to first-line, platinum-based chemotherapy with high-grade serous or endometrioid EOC should be offered PARPi maintenance therapy with niraparib. For patients with germline or somatic pathogenic or likely pathogenic variants in  BRCA1  (g/s BRCA 1) or  BRCA2  (g/s BRCA 2) genes should be treated with olaparib. The addition of olaparib to bevacizumab may be offered to patients with stage III-IV EOC with g/s BRCA1/ 2 and/or genomic instability and a partial or complete response to chemotherapy plus bevacizumab combination. Maintenance therapy (second line or more) with single-agent PARPi may be offered for patients with EOC who have not received a PARPi and have responded to platinum-based therapy regardless of  BRCA  mutation status. Treatment with a PARPi should be offered to patients with recurrent EOC that has not recurred within 6 months of platinum-based therapy, who have not received a PARPi and have a g/s BRCA1/2 , or whose tumor demonstrates genomic instability. PARPis are not recommended for use in combination with chemotherapy, other targeted agents, or immune-oncology agents in the recurrent setting outside the context of a clinical trial. Recommendations for managing specific adverse events are presented. Data to support reuse of PARPis in any setting are needed.Additional information is available at www.asco.org/gynecologic-cancer-guidelines.",2020,(g/s BRCA 1) or  BRCA2  ,"['patients with EOC who have not received a PARPi and have responded to platinum-based therapy regardless of  BRCA  mutation status', 'patients with germline or somatic pathogenic or likely pathogenic variants in  BRCA1', 'All patients with newly diagnosed, stage III-IV EOC whose disease is in complete or partial response to first-line, platinum-based chemotherapy with high-grade serous or endometrioid EOC']","['Maintenance therapy (second line or more) with single-agent PARPi', 'PARP Inhibitors', 'PARPi', 'poly(ADP-ribose) polymerase inhibitors (PARPis', 'bevacizumab']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C1528558', 'cui_str': 'BRCA1 protein, human'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0440743', 'cui_str': 'Serous'}]","[{'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]",[],,0.0750957,(g/s BRCA 1) or  BRCA2  ,"[{'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Tew', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Lacchetti', 'Affiliation': 'American Society of Clinical Oncology, Alexandria, VA.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Ellis', 'Affiliation': 'SHARE Cancer Support, New York, NY.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Maxian', 'Affiliation': 'Ovarian Cancer Project, Williamsville, NY.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'The Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bookman', 'Affiliation': 'Kaiser Permanente, San Francisco, CA.'}, {'ForeName': 'Monica Brown', 'Initials': 'MB', 'LastName': 'Jones', 'Affiliation': 'DeCesaris Cancer Institute, Anne Arundel Medical Center, Annapolis, MD.'}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Lheureux', 'Affiliation': 'University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Joyce F', 'Initials': 'JF', 'LastName': 'Liu', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Kathleen N', 'Initials': 'KN', 'LastName': 'Moore', 'Affiliation': 'Stephenson Cancer Center, Oklahoma City, OK.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Muller', 'Affiliation': 'University of New Mexico, Albuquerque, NM.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Rodriguez', 'Affiliation': 'Virginia Cancer Specialists, Arlington, VA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Walsh', 'Affiliation': 'Cedars-Sinai, West Hollywood, CA.'}, {'ForeName': 'Shannon N', 'Initials': 'SN', 'LastName': 'Westin', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Elise C', 'Initials': 'EC', 'LastName': 'Kohn', 'Affiliation': 'National Cancer Institute, Bethesda, MD.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01924']
2406,32784162,"Comparison between Fluoroplastic and Platinum/Titanium Piston in Stapedotomy: A Prospective, Randomized Clinical Study.","OBJECTIVES


The objective of this study was to compare hearing results of fluoroplastic (Teflon) Causse Loop Piston with platinum/titanium (Big Easy) Piston in patients who underwent stapedotomy due to otosclerosis.
MATERIALS AND METHODS


In this prospective randomized clinical trial study, Causse Loop Piston prosthesis was used in 76 ears and the Big Easy Piston prosthesis in 72 ears. The main outcomes were preoperative and postoperative pure tone audiometry and air-bone gap (ABG).
RESULTS


Postoperative ABG closure was not significantly different between both groups. However, the Causse Loop Piston resulted in a significant improvement of the air conduction (AC) in frequencies of 250, 500, and 1,000 Hz. In addition, the improvement of speech reception threshold (SRT) was significantly higher in Causse Loop Piston group.
CONCLUSION


We achieved similar postoperative ABG closure in short-term with both prostheses. However, at low frequencies, AC gain was higher in Causse Loop Piston group. In addition, patients in this group yielded better SRT.",2020,"In addition, the improvement of speech reception threshold (SRT) was significantly higher in Causse Loop Piston group.
","['76 ears and the Big Easy Piston prosthesis in 72 ears', 'Stapedotomy', 'patients who underwent stapedotomy due to otosclerosis']","['Causse Loop Piston with platinum/titanium (Big Easy) Piston', 'Fluoroplastic and Platinum/Titanium Piston', 'Causse Loop Piston prosthesis']","['air conduction (AC', 'AC gain', 'preoperative and postoperative pure tone audiometry and air-bone gap (ABG', 'SRT', 'Postoperative ABG closure', 'postoperative ABG closure', 'speech reception threshold (SRT', 'hearing results of fluoroplastic (Teflon']","[{'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0441230', 'cui_str': 'Ossicular piston prosthesis'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0395740', 'cui_str': 'Small fenestra stapedectomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0029899', 'cui_str': 'Otosclerosis'}]","[{'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0441230', 'cui_str': 'Ossicular piston prosthesis'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}]","[{'cui': 'C0234744', 'cui_str': 'Air conduction'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004292', 'cui_str': 'Pure tone audiometry'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}]",,0.083494,"In addition, the improvement of speech reception threshold (SRT) was significantly higher in Causse Loop Piston group.
","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Department of Otolaryngology, Otolaryngology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sareh', 'Initials': 'S', 'LastName': 'Roosta', 'Affiliation': 'Department of Biostatistics, Otolaryngology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Daneshian', 'Affiliation': 'Otolaryngology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",The journal of international advanced otology,['10.5152/iao.2020.5129']
2407,32784257,"Study protocol for the use of photobiomodulation with red or infrared LED on waist circumference reduction: a randomised, double-blind clinical trial.","INTRODUCTION


The search for non-invasive procedures to reduce localised adiposity in aesthetics clinics has recently been increasing. In this context, procedures, such as cryolipolysis, ultracavitation, photobiomodulation (PBM) and other techniques have been proposed. Some studies have shown that PBM can be used in body contouring. However, there is no standardisation of the protocol. More than that, as in other techniques for reducing adipose tissue, the availability of triacylglycerol may affect the lipid profile in the blood, bringing consequences to the general health of an individual. This work will aim to compare the light wavelengths when using PBM as a technique for reducing the abdominal waist circumference, while also evaluating the efficacy of the method. Changes in the lipid profile in the blood, with a long-term follow-up, will also be appraised.
METHODS AND ANALYSIS


This will be a controlled, randomised, double-blind, single-centred clinical trial. 174 patients will be recruited at the Nove de Julho University, Brazil, and then divided into three groups: Group A-RED PBM; Group B-INFRARED PBM; Group C-PLACEBO ( Sham ) treatment. The treatments will consist of eight sessions, two times a week, for 4 weeks. At each session, the participants will receive 30 minutes PBM (using a radiant exposure of 127 J/cm 2 ), with an abdominal strap containing 4 LED clusters, with 72 devices each, following the indication of randomisation. All of the groups will receive 30 min of Aussie Current, at 4 kHz, modulated at 10 Hz, 40-60 mA. The main outcome of this study will be waist circumference reduction. The secondary variables will be anthropometric data, lipid profile, liver function and adipose tissue thickness, changes in the local microcirculation, and the quality of life and self-esteem. The analyses will be performed at four stages of the research, D0, end of the eighth session (D30), 15 days after the last session (FU15), 90 days after the last session (FU90) and 180 days after the last session (FU180).
ETHICS AND DISSEMINATION


The Ethics Committee of the Nove de Julho University, Brazil, approved the modified version of this project under No. 3414146 on 26 June 2019. This study is not yet recruiting. The results obtained will be published in a peer-reviewed journal in the related field.
TRIAL REGISTRATION NUMBER


Brazilian Registry of Clinical Trials-ReBec (RBR-9bwxcx).",2020,The search for non-invasive procedures to reduce localised adiposity in aesthetics clinics has recently been increasing.,"['174 patients will be recruited at the Nove de Julho University, Brazil, and then divided into three groups']","['photobiomodulation with red or infrared LED', 'Group A-RED PBM', 'PBM']","['abdominal waist circumference', 'anthropometric data, lipid profile, liver function and adipose tissue thickness, changes in the local microcirculation, and the quality of life and self-esteem', 'waist circumference reduction']","[{'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",174.0,0.176906,The search for non-invasive procedures to reduce localised adiposity in aesthetics clinics has recently been increasing.,"[{'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Marreira', 'Affiliation': 'Biophotonics Applied to Health Sciences, Universidade Nove de Julho, Sao Paulo, Brazil.'}, {'ForeName': 'Lidiane', 'Initials': 'L', 'LastName': 'Rocha Mota', 'Affiliation': 'Biophotonics Applied to Health Sciences, Universidade Nove de Julho, Sao Paulo, Brazil.'}, {'ForeName': 'Daniela Fátima Teixeira', 'Initials': 'DFT', 'LastName': 'Silva', 'Affiliation': 'Biophotonics Applied to Health Sciences, Universidade Nove de Julho, Sao Paulo, Brazil.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Pavani', 'Affiliation': 'Biophotonics Applied to Health Sciences, Universidade Nove de Julho, Sao Paulo, Brazil chrispavani@gmail.com.'}]",BMJ open,['10.1136/bmjopen-2019-036684']
2408,32784263,'Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing' (PIVOT with MI) trial: a protocol for a cluster randomised controlled trial of a clinician vaccine communication intervention.,"INTRODUCTION


A key contributor to underimmunisation is parental refusal or delay of vaccines due to vaccine concerns. Many clinicians lack confidence in communicating with vaccine-hesitant parents (VHP) and perceive that their discussions will do little to change parents' minds. Improving clinician communication with VHPs is critical to increasing childhood vaccine uptake.
METHODS AND ANALYSIS


We describe the protocol for a cluster randomised controlled trial to test the impact of a novel, multifaceted clinician vaccine communication strategy on child immunisation status. The trial will be conducted in 24 primary care practices in two US states (Washington and Colorado). The strategy is called Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT with MI), and involves clinicians initiating the vaccine conversation with all parents of young children using the presumptive format, and among those parents who resist vaccines, pivoting to using MI. Our primary outcome is the immunisation status of children of VHPs at 19 months, 0 day of age expressed as the percentage of days underimmunised from birth to 19 months for 22 doses of eight vaccines recommended during this interval. Secondary outcomes include clinician experience communicating with VHPs, parent visit experience and clinician adherence to the PIVOT with MI communication strategy.
ETHICS AND DISSEMINATION


This study is approved by the following institutional review boards: Colorado Multiple Institutional Review Board, Washington State Institutional Review Board and Swedish Health Services Institutional Review Board. Results will be disseminated through peer-reviewed manuscripts and conference presentations.
TRIAL REGISTRATION NUMBER


NCT03885232.",2020,"Secondary outcomes include clinician experience communicating with VHPs, parent visit experience and clinician adherence to the PIVOT with MI communication strategy.
","['24 primary care practices in two US states (Washington and Colorado', 'child immunisation status']","['clinician vaccine communication intervention', 'multifaceted clinician vaccine communication strategy', 'Motivational Interviewing (PIVOT with MI']","['clinician experience communicating with VHPs, parent visit experience and clinician adherence to the PIVOT with MI communication strategy', 'immunisation status of children of VHPs']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0552506', 'cui_str': 'Immunization status'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1274143', 'cui_str': 'Communication interventions'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205196', 'cui_str': 'Communicating'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0552506', 'cui_str': 'Immunization status'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]",24.0,0.0932297,"Secondary outcomes include clinician experience communicating with VHPs, parent visit experience and clinician adherence to the PIVOT with MI communication strategy.
","[{'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Opel', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington, USA douglas.opel@seattlechildrens.org.""}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Robinson', 'Affiliation': 'Department of Communication, Portland State University, Portland, Oregon, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Spielvogle', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Spina', 'Affiliation': ""Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Garrett', 'Affiliation': ""Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Dempsey', 'Affiliation': ""Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Cathryn', 'Initials': 'C', 'LastName': 'Perreira', 'Affiliation': ""Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Dickinson', 'Affiliation': ""Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pahud', 'Affiliation': 'Department of Pediatrics, University of Missouri-Kansas City, Kansas City, Missouri, USA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Taylor', 'Affiliation': 'Department of Pediatrics, University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'Sean T', 'Initials': 'ST', 'LastName': ""O'Leary"", 'Affiliation': ""Children's Hospital Colorado, Aurora, Colorado, USA.""}]",BMJ open,['10.1136/bmjopen-2020-039299']
2409,32784346,"Intravenous vortioxetine to accelerate onset of effect in major depressive disorder: a 7-day randomized, double-blind, placebo-controlled exploratory study.","This 7-day randomized, double-blind, placebo-controlled fixed-dose study (NCT03766867) explored the potential for accelerating the onset of antidepressant efficacy of single-dose intravenous (IV) vortioxetine at oral vortioxetine treatment initiation. Patients (ages 18-65 years) hospitalized per standard-of-care with major depressive disorder, who were currently treated with a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor for a major depressive episode [Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 30], received one dose of single-blind IV placebo (1-day placebo lead-in period) before being randomly switched to either single-dose IV vortioxetine 25 mg plus daily oral vortioxetine 10 mg (n = 39), or IV placebo plus daily oral placebo (n = 41). In the placebo lead-in period, patients improved slightly by 0.6 MADRS-6 point; however, at day 1 after randomization, both treatment groups had improved by approximately 3 MADRS-6 points (mean difference = -0.8; P = 0.263), the study thus not meeting its primary endpoint. Similar results were seen for other outcomes except a numerically larger improvement in anxiety symptoms with vortioxetine vs placebo. Pharmacokinetic data confirmed that IV vortioxetine facilitated reaching steady-state plasma concentration within 24 h. IV plus oral vortioxetine was well tolerated, with low levels of nausea as the most common adverse event.",2020,Similar results were seen for other outcomes except a numerically larger improvement in anxiety symptoms with vortioxetine vs placebo.,"['Patients (ages 18-65\u2009years) hospitalized per standard-of-care with major depressive disorder, who were currently treated with a', 'for a major depressive episode [Montgomery-Åsberg Depression Rating Scale (MADRS) total score\u2009≥\u200930', 'major depressive disorder']","['vortioxetine 25\u2009mg plus daily oral vortioxetine', 'vortioxetine', 'vortioxetine vs placebo', 'placebo (1-day placebo lead-in period', 'Intravenous vortioxetine', 'selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor', 'placebo plus daily oral placebo', 'single-dose intravenous (IV) vortioxetine', 'placebo']","['nausea', 'anxiety symptoms', 'reaching steady-state plasma concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C1319313', 'cui_str': 'Norepinephrine reuptake inhibitor-containing product'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.68684,Similar results were seen for other outcomes except a numerically larger improvement in anxiety symptoms with vortioxetine vs placebo.,"[{'ForeName': 'Elmars', 'Initials': 'E', 'LastName': 'Rancans', 'Affiliation': 'Department of Psychiatry and Narcology, Riga Stradins University, Riga, Latvia.'}, {'ForeName': 'Janos', 'Initials': 'J', 'LastName': 'Zambori', 'Affiliation': 'H. Lundbeck A/S, Valby, Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Dalsgaard', 'Affiliation': 'H. Lundbeck A/S, Valby, Denmark.'}, {'ForeName': 'Corine', 'Initials': 'C', 'LastName': 'Baayen', 'Affiliation': 'H. Lundbeck A/S, Valby, Denmark.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Areberg', 'Affiliation': 'H. Lundbeck A/S, Valby, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Ettrup', 'Affiliation': 'H. Lundbeck A/S, Valby, Denmark.'}, {'ForeName': 'Ioana', 'Initials': 'I', 'LastName': 'Florea', 'Affiliation': 'H. Lundbeck A/S, Valby, Denmark.'}]",International clinical psychopharmacology,['10.1097/YIC.0000000000000326']
2410,32784372,Heart Rate Variability Behavior during Exercise and Short-Term Recovery Following Energy Drink Consumption in Men and Women.,"This study examined the cardiac autonomic responses, as measured by heart rate variability (HRV), during cycling exercise and short-term rest after energy drink consumption. Seventeen participants (seven males and 10 females; age: 22.8 ± 3.5 years; BMI: 24.3 ± 3.3 kg/m 2 ) completed this double-blind, placebo-controlled, counterbalanced crossover design study. Participants received an energy drink formula containing 140 mg of caffeine and a placebo in a randomized order before completing a 10-min steady-state warm up (WUP) and a graded exercise test to exhaustion (GXT) followed by a 15-min short-term rest (STR) period. Heartbeat intervals were recorded using a heart rate monitor. Data were divided into WUP, GXT, and STR phases, and HRV parameters were averaged within each phase. Additionally, root mean square of the standard deviation of R-R intervals (RMSSD) during GXT was analyzed to determine the HRV threshold. Separate two-way (sex (male vs. female) x drink (energy drink vs. placebo)) repeated measures ANOVA were utilized. Significant increases in high frequency (HF) and RMSSD were shown during WUP after energy drink consumption, while interactions between drink and sex were observed for HRV threshold parameters (initial RMSSD and rate of RMSSD decline). No significant differences were noted during STR. Energy drink consumption may influence cardiac autonomic responses during low-intensity exercise, and sex-based differences in response to graded exercise to exhaustion may exist.",2020,"Significant increases in high frequency (HF) and RMSSD were shown during WUP after energy drink consumption, while interactions between drink and sex were observed for HRV threshold parameters (initial RMSSD and rate of RMSSD decline).","['Seventeen participants (seven males and 10 females; age: 22.8 ± 3.5 years; BMI: 24.3 ± 3.3 kg/m 2 ', 'Men and Women']","['energy drink formula containing 140 mg of caffeine and a placebo', '10-min steady-state warm up (WUP) and a graded exercise test to exhaustion (GXT) followed by a 15-min short-term rest (STR) period', 'drink (energy drink vs. placebo', 'cycling exercise and short-term rest after energy drink consumption', 'Exercise and Short-Term Recovery Following Energy Drink Consumption', 'placebo']","['heart rate variability (HRV', 'root mean square of the standard deviation of R-R intervals (RMSSD', 'cardiac autonomic responses', 'high frequency (HF) and RMSSD']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C3179078', 'cui_str': 'Energy drink'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}]",,0.161957,"Significant increases in high frequency (HF) and RMSSD were shown during WUP after energy drink consumption, while interactions between drink and sex were observed for HRV threshold parameters (initial RMSSD and rate of RMSSD decline).","[{'ForeName': 'Nicolas W', 'Initials': 'NW', 'LastName': 'Clark', 'Affiliation': 'Physiology of Work and Exercise Response (POWER) Laboratory, Institute of Exercise Physiology and Rehabilitation Science, University of Central Florida, 12494 University Blvd., Orlando, FL 32816, USA.'}, {'ForeName': 'Chad H', 'Initials': 'CH', 'LastName': 'Herring', 'Affiliation': 'Physiology of Work and Exercise Response (POWER) Laboratory, Institute of Exercise Physiology and Rehabilitation Science, University of Central Florida, 12494 University Blvd., Orlando, FL 32816, USA.'}, {'ForeName': 'Erica R', 'Initials': 'ER', 'LastName': 'Goldstein', 'Affiliation': 'Physiology of Work and Exercise Response (POWER) Laboratory, Institute of Exercise Physiology and Rehabilitation Science, University of Central Florida, 12494 University Blvd., Orlando, FL 32816, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Stout', 'Affiliation': 'Physiology of Work and Exercise Response (POWER) Laboratory, Institute of Exercise Physiology and Rehabilitation Science, University of Central Florida, 12494 University Blvd., Orlando, FL 32816, USA.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Wells', 'Affiliation': 'Division of Kinesiology, School of Kinesiology and Physical Therapy, University of Central Florida, 12494 University Blvd., Orlando, FL 32816, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Fukuda', 'Affiliation': 'Physiology of Work and Exercise Response (POWER) Laboratory, Institute of Exercise Physiology and Rehabilitation Science, University of Central Florida, 12494 University Blvd., Orlando, FL 32816, USA.'}]",Nutrients,['10.3390/nu12082372']
2411,32784625,Prescriber Commitment Posters to Increase Prudent Antibiotic Prescribing in English General Practice: A Cluster Randomized Controlled Trial.,"Unnecessary antibiotic prescribing contributes to Antimicrobial Resistance posing a major public health risk. Estimates suggest as many as half of antibiotics prescribed for respiratory infections may be unnecessary. We conducted a three-armed unblinded cluster randomized controlled trial (ISRCTN trial registry 83322985). Interventions were a commitment poster (CP) advocating safe antibiotic prescribing or a CP plus an antimicrobial stewardship message (AM) on telephone appointment booking lines, tested against a usual care control group. The primary outcome measure was antibiotic item dispensing rates per 1000 population adjusted for practice demographics. The outcome measures for post-hoc analysis were dispensing rates of antibiotics usually prescribed for upper respiratory tract infections and broad spectrum antibiotics. In total, 196 practice units were randomized to usual care ( n  = 60), CP ( n  = 66), and CP&AM ( n  = 70). There was no effect on the overall dispensing rates for either interventions compared to usual care (CP 5.673, 95%CI -9.768 to 21.113,  p  = 0.458; CP&AM, -12.575, 95%CI -30.726 to 5.576,  p  = 0.167). Secondary analysis, which included pooling the data into one model, showed a significant effect of the AM (-18.444, 95%CI -32.596 to -4.292,  p  = 0.012). Fewer penicillins and macrolides were prescribed in the CP&AM intervention compared to usual care (-12.996, 95% CI -34.585 to -4.913,  p  = 0.018). Commitment posters did not reduce antibiotic prescribing. An automated patient antimicrobial stewardship message showed effects and requires further testing.",2020,"There was no effect on the overall dispensing rates for either interventions compared to usual care (CP 5.673, 95%CI -9.768 to 21.113,  p  = 0.458;",['196 practice units'],"['CP plus an antimicrobial stewardship message (AM', 'CP&AM intervention']","['dispensing rates of antibiotics usually prescribed for upper respiratory tract infections and broad spectrum antibiotics', 'overall dispensing rates', 'antibiotic item dispensing rates per 1000 population adjusted for practice demographics']","[{'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0376675', 'cui_str': 'Posters'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4505099', 'cui_str': 'Antimicrobial Stewardship'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",,0.134725,"There was no effect on the overall dispensing rates for either interventions compared to usual care (CP 5.673, 95%CI -9.768 to 21.113,  p  = 0.458;","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sallis', 'Affiliation': 'Public Health England Behavioural Insights (PHEBI), Research, Translation & Innovation, Public Health England, Wellington House, 133-155 Waterloo Rd, Lambeth, London SE1 8UG, UK.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Bondaronek', 'Affiliation': 'Public Health England Behavioural Insights (PHEBI), Research, Translation & Innovation, Public Health England, Wellington House, 133-155 Waterloo Rd, Lambeth, London SE1 8UG, UK.'}, {'ForeName': 'Jet G', 'Initials': 'JG', 'LastName': 'Sanders', 'Affiliation': 'Public Health England Behavioural Insights (PHEBI), Research, Translation & Innovation, Public Health England, Wellington House, 133-155 Waterloo Rd, Lambeth, London SE1 8UG, UK.'}, {'ForeName': 'Ly-Mee', 'Initials': 'LM', 'LastName': 'Yu', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences University of Oxford, Radcliffe Primary Care, Radcliffe Observatory Quarter, Woodstock Road, Oxford OX2 6GG, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Harris', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences University of Oxford, Radcliffe Primary Care, Radcliffe Observatory Quarter, Woodstock Road, Oxford OX2 6GG, UK.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Vlaev', 'Affiliation': 'Warwick Business School, University of Warwick, Coventry CV4 7AL, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sanders', 'Affiliation': 'The Behavioural Insights Team. 4 Matthew Parker St, Westminster, London SW1H 9NP, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tonkin-Crine', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences University of Oxford, Radcliffe Primary Care, Radcliffe Observatory Quarter, Woodstock Road, Oxford OX2 6GG, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Chadborn', 'Affiliation': 'Public Health England Behavioural Insights (PHEBI), Research, Translation & Innovation, Public Health England, Wellington House, 133-155 Waterloo Rd, Lambeth, London SE1 8UG, UK.'}]","Antibiotics (Basel, Switzerland)",['10.3390/antibiotics9080490']
2412,32784758,Ultra-Processed Food Consumption Is Associated with Abdominal Obesity: A Prospective Cohort Study in Older Adults.,"INTRODUCTION AND OBJECTIVES


Ultra-processed food (UPF) consumption has been associated with increased incidence of cardiovascular disease and its risk factors. The aim of this study was to assess, for the first time in the literature, the prospective association between UPF consumption and the incidence of abdominal obesity (AO) in older adults.
METHODS


The study sample consists of 652 participants in the Seniors Study on Nutrition and Cardiovascular Risk in Spain: Seniors-ENRICA-1 study, (mean age 67, 44% women). At baseline, standardized anthropometric measurements were collected (including abdominal circumference). After a median follow-up of six years, the abdominal circumference was measured again, and the incidence of abdominal obesity (AO) was calculated, defined as an abdominal perimeter ≥102 cm in men and ≥88 cm in women. At baseline, dietary information was collected using a computerized and validated dietary history. Information was obtained on the usual diet in the previous year. A total number of 880 foods were classified according to their degree of processing following the NOVA classification. Foods or drinks formulated mostly or entirely from substances derived from foods, with little or no presence of the unaltered original food were classified as UPF. For each participant, the percentage of energy from UPF was derived and sex-specific tertiles were calculated. Logistic regression models were built and adjusted for sociodemographic, lifestyle, morbidity, and drug treatment variables.
RESULTS


Among those participants without AO at baseline, 177 developed AO during follow-up. The average consumption of UPF was 17% of total energy (7% in the first tertile; 29% in the third tertile). The odds ratio (95% confidence interval) for incident AO risk when compared to the lowest tertile was: 1.55 (0.99-2.44) for the second tertile of UPF consumption and 1.62 (1.04-2.54) for the third tertile;  p  for linear trend: 0.037. Results remained statistically significant after adjusting for potential dietary confounding factors such as fiber consumption, the intake of very long chain omega-3 fatty acids and adherence to the Mediterranean diet.
CONCLUSIONS


A higher UPF consumption is positively associated with incident AO in older adults in Spain. These findings extend the current evidence of the detrimental effect of UPF consumption on cardiometabolic health.",2020,"Results remained statistically significant after adjusting for potential dietary confounding factors such as fiber consumption, the intake of very long chain omega-3 fatty acids and adherence to the Mediterranean diet.
","['Older Adults', 'older adults', 'Abdominal Obesity', 'older adults in Spain', 'Seniors-ENRICA-1 study, (mean age 67, 44% women', '652 participants in the Seniors Study on Nutrition and Cardiovascular Risk in Spain']",['Ultra-Processed Food Consumption'],"['abdominal obesity (AO', 'incident AO risk', 'abdominal circumference', 'incidence of abdominal obesity (AO', 'average consumption of UPF']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0344355', 'cui_str': 'Convenience food'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0344355', 'cui_str': 'Convenience food'}]",880.0,0.0426123,"Results remained statistically significant after adjusting for potential dietary confounding factors such as fiber consumption, the intake of very long chain omega-3 fatty acids and adherence to the Mediterranean diet.
","[{'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Sandoval-Insausti', 'Affiliation': 'Department of Preventive Medicine and Public Health, School of Medicine, Universidad Autónoma de Madrid-IdiPaz, CIBERESP (CIBER of Epidemiology and Public Health), 28029 Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Jiménez-Onsurbe', 'Affiliation': 'Department of Preventive Medicine and Public Health, School of Medicine, Universidad Autónoma de Madrid-IdiPaz, CIBERESP (CIBER of Epidemiology and Public Health), 28029 Madrid, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Donat-Vargas', 'Affiliation': 'Department of Preventive Medicine and Public Health, School of Medicine, Universidad Autónoma de Madrid-IdiPaz, CIBERESP (CIBER of Epidemiology and Public Health), 28029 Madrid, Spain.'}, {'ForeName': 'Jimena', 'Initials': 'J', 'LastName': 'Rey-García', 'Affiliation': 'Department of Preventive Medicine and Public Health, School of Medicine, Universidad Autónoma de Madrid-IdiPaz, CIBERESP (CIBER of Epidemiology and Public Health), 28029 Madrid, Spain.'}, {'ForeName': 'José R', 'Initials': 'JR', 'LastName': 'Banegas', 'Affiliation': 'Department of Preventive Medicine and Public Health, School of Medicine, Universidad Autónoma de Madrid-IdiPaz, CIBERESP (CIBER of Epidemiology and Public Health), 28029 Madrid, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Rodríguez-Artalejo', 'Affiliation': 'Department of Preventive Medicine and Public Health, School of Medicine, Universidad Autónoma de Madrid-IdiPaz, CIBERESP (CIBER of Epidemiology and Public Health), 28029 Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Guallar-Castillón', 'Affiliation': 'Department of Preventive Medicine and Public Health, School of Medicine, Universidad Autónoma de Madrid-IdiPaz, CIBERESP (CIBER of Epidemiology and Public Health), 28029 Madrid, Spain.'}]",Nutrients,['10.3390/nu12082368']
2413,32784847,Effects of Whey and Pea Protein Supplementation on Post-Eccentric Exercise Muscle Damage: A Randomized Trial.,"This randomized trial compared pea protein, whey protein, and water-only supplementation on muscle damage, inflammation, delayed onset of muscle soreness (DOMS), and physical fitness test performance during a 5-day period after a 90-min eccentric exercise bout in non-athletic non-obese males ( n  = 92, ages 18-55 years). The two protein sources (0.9 g protein/kg divided into three doses/day) were administered under double blind procedures. The eccentric exercise protocol induced significant muscle damage and soreness, and reduced bench press and 30-s Wingate performance. Whey protein supplementation significantly attenuated post-exercise blood levels for biomarkers of muscle damage compared to water-only, with large effect sizes for creatine kinase and myoglobin during the fourth and fifth days of recovery (Cohen's d > 0.80); pea protein versus water supplementation had an intermediate non-significant effect (Cohen's d < 0.50); and no significant differences between whey and pea protein were found. Whey and pea protein compared to water supplementation had no significant effects on post-exercise DOMS and the fitness tests. In conclusion, high intake of whey protein for 5 days after intensive eccentric exercise mitigated the efflux of muscle damage biomarkers, with the intake of pea protein having an intermediate effect.",2020,Whey and pea protein compared to water supplementation had no significant effects on post-exercise DOMS and the fitness tests.,"['non-athletic non-obese males ( n  = 92, ages 18-55 years']","['Whey and Pea Protein Supplementation', 'eccentric exercise protocol', 'pea protein, whey protein, and water-only supplementation', 'eccentric exercise bout', 'Whey protein supplementation']","['post-exercise DOMS and the fitness tests', 'efflux of muscle damage biomarkers', 'muscle damage and soreness, and reduced bench press and 30-s Wingate performance', 'Post-Eccentric Exercise Muscle Damage', 'muscle damage, inflammation, delayed onset of muscle soreness (DOMS), and physical fitness test performance', 'post-exercise blood levels', 'creatine kinase and myoglobin']","[{'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C3535674', 'cui_str': 'Pea Proteins'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0027078', 'cui_str': 'Myoglobin'}]",,0.0676613,Whey and pea protein compared to water supplementation had no significant effects on post-exercise DOMS and the fitness tests.,"[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Nieman', 'Affiliation': 'Human Performance Laboratory, Department of Biology, Appalachian State University, North Carolina Research Campus, Kannapolis, NC 28608, USA.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Zwetsloot', 'Affiliation': 'Department of Health and Exercise Science, Appalachian State University, Boone, NC 28608, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Simonson', 'Affiliation': 'Human Performance Laboratory, Department of Biology, Appalachian State University, North Carolina Research Campus, Kannapolis, NC 28608, USA.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Hoyle', 'Affiliation': 'Human Performance Laboratory, Department of Biology, Appalachian State University, North Carolina Research Campus, Kannapolis, NC 28608, USA.'}, {'ForeName': 'Xintang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'China Academy of Sport and Health Sciences, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Heather K', 'Initials': 'HK', 'LastName': 'Nelson', 'Affiliation': 'Nutrition and Health Research & Development, Roquette, Geneva, IL 60134, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Lefranc-Millot', 'Affiliation': 'Nutrition and Health Research & Development, Roquette, 62136 Lestrem, France.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Guérin-Deremaux', 'Affiliation': 'Nutrition and Health Research & Development, Roquette, 62136 Lestrem, France.'}]",Nutrients,['10.3390/nu12082382']
2414,32784930,"Safety, Tolerability, Pharmacokinetics, and Concentration-QTc Analysis of Tetrodotoxin: A Randomized, Dose Escalation Study in Healthy Adults.","Tetrodotoxin (TTX) is a highly specific voltage-gated sodium channel (VGSC) blocker in clinical evaluation as a peripheral-acting analgesic for chronic pain. This study presents the first published results of the safety including cardiac liability of TTX at therapeutic-relevant concentrations in twenty-five healthy adults. Randomized, double-blind, placebo-, and positive- (moxifloxacin) controlled study evaluated single ascending doses of 15 µg, 30 µg, and 45 µg TTX over 3 periods with a 7-day washout between each period. Subcutaneous injections of TTX were readily absorbed, reaching maximum plasma concentration (C max ) within 1.5 h. Both extent of exposure (AUC) and C max  increased in proportion to dose. No QT prolongation was identified by concentration-QTc analysis and the upper bounds of the two-sided 90% confidence interval of predicted maximum baseline and placebo corrected QTcF (ΔΔQTcF) value did not exceed 10 ms for all tetrodotoxin doses, thereby meeting the criteria of a negative QT study. Safety assessments showed no clinically relevant changes with values similar between all groups and no subject withdrawing due to adverse events. Paresthesia, oral-paresthesia, headache, dizziness, nausea, and myalgia were the most common TEAEs (overall occurrence ≥5%) in the TTX treatment groups. TTX doses investigated in this study are safe, well-tolerated, and lack proarrhythmic proclivity.",2020,"No QT prolongation was identified by concentration-QTc analysis and the upper bounds of the two-sided 90% confidence interval of predicted maximum baseline and placebo corrected QTcF (ΔΔQTcF) value did not exceed 10 ms for all tetrodotoxin doses, thereby meeting the criteria of a negative QT study.","['Healthy Adults', 'twenty-five healthy adults']","['sodium channel (VGSC) blocker', 'placebo-, and positive- (moxifloxacin', 'Tetrodotoxin (TTX', 'TTX']","['Paresthesia, oral-paresthesia, headache, dizziness, nausea, and myalgia', 'QT prolongation', 'Safety, Tolerability, Pharmacokinetics, and Concentration-QTc Analysis of Tetrodotoxin']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C3715062', 'cui_str': '25'}]","[{'cui': 'C0037492', 'cui_str': 'Sodium Channel'}, {'cui': 'C3494197', 'cui_str': 'Sodium Channels, Voltage-Gated'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0039705', 'cui_str': 'Tetrodotoxin'}]","[{'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0521591', 'cui_str': 'Oral paresthesia'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0039705', 'cui_str': 'Tetrodotoxin'}]",25.0,0.197221,"No QT prolongation was identified by concentration-QTc analysis and the upper bounds of the two-sided 90% confidence interval of predicted maximum baseline and placebo corrected QTcF (ΔΔQTcF) value did not exceed 10 ms for all tetrodotoxin doses, thereby meeting the criteria of a negative QT study.","[{'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Kavoosi', 'Affiliation': 'WEX Pharmaceuticals Inc., Vancouver, BC V6E-4A6, Canada.'}, {'ForeName': 'Terry E', 'Initials': 'TE', 'LastName': ""O'Reilly"", 'Affiliation': 'Celerion Inc., Tempe, AZ 85283, USA.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Kavoosi', 'Affiliation': 'WEX Pharmaceuticals Inc., Vancouver, BC V6E-4A6, Canada.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Chai', 'Affiliation': 'Celerion Inc., Lincoln, NE 68502, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Engel', 'Affiliation': 'Celerion Inc., Montreal, QC H4M-2P1, Canada.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Korz', 'Affiliation': 'WEX Pharmaceuticals Inc., Vancouver, BC V6E-4A6, Canada.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Gallen', 'Affiliation': 'WEX Pharmaceuticals Inc., Vancouver, BC V6E-4A6, Canada.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Lester', 'Affiliation': 'Celerion Inc., Tempe, AZ 85283, USA.'}]",Toxins,['10.3390/toxins12080511']
2415,32785021,A Five-Ingredient Nutritional Supplement and Home-Based Resistance Exercise Improve Lean Mass and Strength in Free-Living Elderly.,"Old age is associated with lower physical activity levels, suboptimal protein intake, and desensitization to anabolic stimuli, predisposing for age-related muscle loss (sarcopenia). Although resistance exercise (RE) and protein supplementation partially protect against sarcopenia under controlled conditions, the efficacy of home-based, unsupervised RE (HBRE) and multi-ingredient supplementation (MIS) is largely unknown. In this randomized, placebo-controlled and double-blind trial, we examined the effects of HBRE/MIS on muscle mass, strength, and function in free-living, older men. Thirty-two sedentary men underwent twelve weeks of home-based resistance band training (3 d/week), in combination with daily intake of a novel five-nutrient supplement ('Muscle5'; M5,  n  = 16, 77.4 ± 2.8 y) containing whey, micellar casein, creatine, vitamin D, and omega-3 fatty acids, or an isocaloric/isonitrogenous placebo (PLA;  n  = 16, 74.4 ± 1.3 y), containing collagen and sunflower oil. Appendicular and total lean mass (ASM; +3%, TLM; +2%), lean mass to fat ratios (ASM/% body fat; +6%, TLM/% body fat; +5%), maximal strength (grip; +8%, leg press; +17%), and function (5-Times Sit-to-Stand time; -9%) were significantly improved in the M5 group following HBRE/MIS therapy (pre vs. post tests;  p  < 0.05). Fast-twitch muscle fiber cross-sectional areas of the quadriceps muscle were also significantly increased in the M5 group post intervention (Type IIa; +30.9%, Type IIx, +28.5%,  p  < 0.05). Sub-group analysis indicated even greater gains in total lean mass in sarcopenic individuals following HBRE/MIS therapy (TLM; +1.65 kg/+3.4%,  p  < 0.05). We conclude that the Muscle5 supplement is a safe, well-tolerated, and effective complement to low-intensity, home-based resistance exercise and improves lean mass, strength, and overall muscle quality in old age.",2020,"Sub-group analysis indicated even greater gains in total lean mass in sarcopenic individuals following HBRE/MIS therapy (TLM; +1.65 kg/+3.4%,  p  < 0.05).","['free-living, older men', 'Thirty-two sedentary men']","['HBRE/MIS', 'containing collagen and sunflower oil', 'Muscle5 supplement', ""home-based resistance band training (3 d/week), in combination with daily intake of a novel five-nutrient supplement ('Muscle5'; M5,  n  = 16, 77.4 ± 2.8 y) containing whey, micellar casein, creatine, vitamin D, and omega-3 fatty acids, or an isocaloric/isonitrogenous placebo"", 'Home-Based Resistance Exercise Improve', 'resistance exercise (RE) and protein supplementation', 'placebo']","['lean mass to fat ratios', 'muscle mass, strength, and function', 'Lean Mass and Strength', 'Appendicular and total lean mass', 'Fast-twitch muscle fiber cross-sectional areas of the quadriceps muscle', 'maximal strength', 'total lean mass', 'safe, well-tolerated, and effective complement to low-intensity, home-based resistance exercise and improves lean mass, strength, and overall muscle quality']","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0947381', 'cui_str': 'Helianthus annuus'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}]","[{'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242873', 'cui_str': 'Skeletal muscle fiber, type II'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009498', 'cui_str': 'Complement'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",32.0,0.0485037,"Sub-group analysis indicated even greater gains in total lean mass in sarcopenic individuals following HBRE/MIS therapy (TLM; +1.65 kg/+3.4%,  p  < 0.05).","[{'ForeName': 'Mats I', 'Initials': 'MI', 'LastName': 'Nilsson', 'Affiliation': 'Department of Pediatrics, McMaster University Medical Center, Hamilton, ON L8N 3Z5, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Mikhail', 'Affiliation': 'Department of Pediatrics, McMaster University Medical Center, Hamilton, ON L8N 3Z5, Canada.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Lan', 'Affiliation': 'Department of Pediatrics, McMaster University Medical Center, Hamilton, ON L8N 3Z5, Canada.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Di Carlo', 'Affiliation': 'Department of Pediatrics, McMaster University Medical Center, Hamilton, ON L8N 3Z5, Canada.'}, {'ForeName': 'Bethanie', 'Initials': 'B', 'LastName': 'Hamilton', 'Affiliation': 'Department of Pediatrics, McMaster University Medical Center, Hamilton, ON L8N 3Z5, Canada.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Barnard', 'Affiliation': 'Department of Pediatrics, McMaster University Medical Center, Hamilton, ON L8N 3Z5, Canada.'}, {'ForeName': 'Bart P', 'Initials': 'BP', 'LastName': 'Hettinga', 'Affiliation': 'Exerkine Corporation, McMaster University Medical Center, Hamilton, ON L8N 3Z5, Canada.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Hatcher', 'Affiliation': 'Department of Pediatrics, McMaster University Medical Center, Hamilton, ON L8N 3Z5, Canada.'}, {'ForeName': 'Milla G', 'Initials': 'MG', 'LastName': 'Tarnopolsky', 'Affiliation': 'Department of Pediatrics, McMaster University Medical Center, Hamilton, ON L8N 3Z5, Canada.'}, {'ForeName': 'Joshua P', 'Initials': 'JP', 'LastName': 'Nederveen', 'Affiliation': 'Department of Pediatrics, McMaster University Medical Center, Hamilton, ON L8N 3Z5, Canada.'}, {'ForeName': 'Adam L', 'Initials': 'AL', 'LastName': 'Bujak', 'Affiliation': 'Exerkine Corporation, McMaster University Medical Center, Hamilton, ON L8N 3Z5, Canada.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'May', 'Affiliation': 'Department of Pediatrics, McMaster University Medical Center, Hamilton, ON L8N 3Z5, Canada.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Tarnopolsky', 'Affiliation': 'Department of Pediatrics, McMaster University Medical Center, Hamilton, ON L8N 3Z5, Canada.'}]",Nutrients,['10.3390/nu12082391']
2416,32785036,"Effects of Daily Consumption of an Aqueous Dispersion of Free-Phytosterols Nanoparticles on Individuals with Metabolic Syndrome: A Randomised, Double-Blind, Placebo-Controlled Clinical Trial.","Metabolic syndrome (MS) affects up to 40% of the population and is associated with heart failure, stroke and diabetes. Phytosterols (PS) could help to manage one or more MS criteria. The purpose of this study was to evaluate the therapeutic effect of daily supplementation of an aqueous dispersion of 2 g of free-phytosterols nanoparticles in individuals with MS over six months of intervention, compared with placebo. This double-blind study included 202 participants with MS randomly assigned into phytosterol ( n  = 102) and placebo ( n  = 100) groups. Participants were assessed at baseline, 4, 12 and 24 weeks. General health questions, anthropometric measurements and blood parameters were analysed. At week 24, the proportion of participants with high triglycerides (≥150 mg/dL) in the phytosterol group was 15.65% lower than in the placebo group ( p -value = 0.023). Similarly, half of the participants in the phytosterol group decreased their waist circumference up to 4 cm compared with 0 cm in the placebo group ( p -value = 0.0001). We reported no adverse effects (diarrhoea or vitamin D reduction); nonetheless, almost 70% of participants in the phytosterol group self-reported an improvement in bowel habits. Daily intake of free-PS nanoparticles improved some MS criteria; therefore, it might be a promising adjuvant therapy for individuals with MS (NCT02969720).",2020,"At week 24, the proportion of participants with high triglycerides (≥150 mg/dL) in the phytosterol group was 15.65% lower than in the placebo group ( p -value = 0.023).","['202 participants with MS randomly assigned into phytosterol ( n  = 102) and', 'Individuals with Metabolic Syndrome']","['Placebo', 'Phytosterols (PS', 'Daily Consumption of an Aqueous Dispersion of Free-Phytosterols Nanoparticles', 'placebo']","['bowel habits', 'waist circumference', 'Metabolic syndrome (MS']","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0031866', 'cui_str': 'Phytosterols'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031866', 'cui_str': 'Phytosterols'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}]","[{'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]",202.0,0.405829,"At week 24, the proportion of participants with high triglycerides (≥150 mg/dL) in the phytosterol group was 15.65% lower than in the placebo group ( p -value = 0.023).","[{'ForeName': 'Yasna K', 'Initials': 'YK', 'LastName': 'Palmeiro-Silva', 'Affiliation': 'School of Nursing, Universidad de los Andes, Las Condes 7550000, Chile.'}, {'ForeName': 'Raúl I', 'Initials': 'RI', 'LastName': 'Aravena', 'Affiliation': 'Department of Chemical Engineering, Imperial College London, London SW7 2BX, UK.'}, {'ForeName': 'Lisette', 'Initials': 'L', 'LastName': 'Ossio', 'Affiliation': 'School of Nursing, Universidad de los Andes, Las Condes 7550000, Chile.'}, {'ForeName': 'Javiera', 'Initials': 'J', 'LastName': 'Parro Fluxa', 'Affiliation': 'School of Nursing, Universidad de los Andes, Las Condes 7550000, Chile.'}]",Nutrients,['10.3390/nu12082392']
2417,32785044,Be Health e  for Your Heart: A Pilot Randomized Controlled Trial Evaluating a Web-Based Behavioral Intervention to Improve the Cardiovascular Health of Women with a History of Preeclampsia.,"This pilot randomized controlled trial (RCT) aimed to determine the acceptability and preliminary efficacy of a web-based cardiovascular disease (CVD) prevention intervention for women following preeclampsia. Australian women with a recent history (≤4 years post diagnosis) of preeclampsia were randomized into two study arms: (1) Be Health e  for your Heart, a web-based behavioral intervention or; (2) Control, access to the National Heart Foundation website. Assessments were conducted at baseline, and after three months. Intervention acceptability and impact on absolute CVD 30-year risk score, CVD risk markers and health behaviors were assessed. Twenty-four of 31 (77.4%) women completed the three-month assessment. Eleven out of 13 intervention participants (84.6%) agreed/strongly agreed they were satisfied with the program, with a mean score of 4.2 ± 0.9 (maximum of five). There were no significant between or within group differences in absolute CVD risk, CVD risk markers or health behaviors from baseline to three months. Women with a history of preeclampsia were successfully recruited and retained and they reported high levels of acceptability with the Be Health e  for your Heart program. Further research is therefore needed from powered trials to determine the impact of web-based lifestyle interventions on CVD risk in this at-risk group.",2020,"There were no significant between or within group differences in absolute CVD risk, CVD risk markers or health behaviors from baseline to three months.","['Australian women with a recent history (≤4 years post diagnosis) of preeclampsia', 'Twenty-four of 31 (77.4', 'Women with a History of Preeclampsia', 'Women with a history of preeclampsia', 'women following preeclampsia', 'Your Heart']","['Web-Based Behavioral Intervention', 'web-based cardiovascular disease (CVD) prevention intervention']","['absolute CVD risk, CVD risk markers or health behaviors', 'absolute CVD 30-year risk score, CVD risk markers and health behaviors', 'Cardiovascular Health']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C4076023', 'cui_str': 'History of pre-eclampsia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",,0.218305,"There were no significant between or within group differences in absolute CVD risk, CVD risk markers or health behaviors from baseline to three months.","[{'ForeName': 'Melinda J', 'Initials': 'MJ', 'LastName': 'Hutchesson', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Vanessa A', 'Initials': 'VA', 'LastName': 'Shrewsbury', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Vincze', 'Affiliation': 'School of Allied Health Sciences & Menzies Health Institute Queensland, Griffith University, Gold Coast, QLD 4222, Australia.'}, {'ForeName': 'Linda E', 'Initials': 'LE', 'LastName': 'Campbell', 'Affiliation': 'School of Psychology, Faculty of Science, The University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Callister', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Biomedical Sciences and Pharmacy, Faculty of Health and Medicine, The University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Felicity', 'Initials': 'F', 'LastName': 'Park', 'Affiliation': 'Department of Maternal Foetal Medicine, John Hunter Hospital, Newcastle, NSW 2305, Australia.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Schumacher', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Clare E', 'Initials': 'CE', 'LastName': 'Collins', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, NSW 2308, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17165779']
2418,32785583,Physiological linkage among successful high-status women in international teams.,"In contemporary society, decisions are often made by teams whose members represent different nationalities and genders. In the current work, participants from 55 countries formed groups of three to four people to select one of five firms in a mock firm search. In all groups, one woman was randomly assigned to have higher status than her groupmates; she was also surreptitiously instructed to persuade her group to select one (randomly-assigned) firm. We measured cardiac interbeat intervals for participants throughout the decision-making process to assess physiological linkage-the degree to which a ""sender's"" physiological response predicts a ""receiver's"" physiological response at a subsequent time interval. On average, high-status women were successful at persuasion. The physiological responses of successful high-status women were also predicted by the responses of their female groupmates: stronger linkage to female group members during the task was associated with success at persuading the group. Successful high-status women were also perceived as more persuasive than others in the group. This work shows that the link between status and successful persuasion generalizes to women among heterogeneous international teams. It also suggests that attention to others-often associated with physiological linkage-may be useful in persuading others during decision-making.",2020,The physiological responses of successful high-status women were also predicted by the responses of their female groupmates: stronger linkage to female group members during the task was associated with success at persuading the group.,[],[],[],[],[],[],,0.0530231,The physiological responses of successful high-status women were also predicted by the responses of their female groupmates: stronger linkage to female group members during the task was associated with success at persuading the group.,"[{'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Thorson', 'Affiliation': 'Dept. of Psychology, Barnard College of Columbia University, 3009 Broadway, New York, NY 10027, USA.'}, {'ForeName': 'Oana D', 'Initials': 'OD', 'LastName': 'Dumitru', 'Affiliation': 'Dept. of Psychology, New York University, 6 Washington Place, New York, NY 10003, USA.'}, {'ForeName': 'Tessa V', 'Initials': 'TV', 'LastName': 'West', 'Affiliation': 'Dept. of Psychology, New York University, 6 Washington Place, New York, NY 10003, USA.'}]",Social cognitive and affective neuroscience,['10.1093/scan/nsaa112']
2419,32785587,Effects of Question Type and Order When Measuring Peak Consumption of Risky Drinking Events.,"AIMS


There is new interest in measuring alcohol consumption during risky drinking events, but there is little guidance on how to best ask such questions. In this study, we contrast two different types of questions on peak consumption over a single heavy drinking occasion. We used a general question that ask respondents to recall the total amount consumed (total consumption question), and location-specific questions that ask respondents to recall consumption in each drinking location (location-specific peak consumption, LSPC).
METHODS


Heavy drinkers (≥11 Australian Standard Drinks (ASD) per occasion for males, ≥8 for females) from the second wave of a prospective cohort study were recruited via landline random digit dial from Melbourne in 2012. Respondents were randomly assigned to surveys of different question order, and either first received total consumption (n = 127) or LSPC questions (n = 147). T-tests compared peak consumption between categories stratified by sex and consumption tercile.
RESULTS


Mean peak consumption was 12.5 ASD. Irrespective of question order, consumption amounts for total consumption and LSPC questions were not significantly different for both sexes. However, drinkers in the highest tercile asked LSPC questions first provided significantly higher consumption estimates in response to the total consumption question than in response to the LSPC questions.
CONCLUSION


At a population level, LSPC and total consumption questions produce similar estimates of peak consumption for risky drinking events. Except for heavy drinkers, general consumption questions may be sufficient when asking about these drinking events in consumption surveys, without the greater response burden of longer LSPC questions.",2020,"Irrespective of question order, consumption amounts for total consumption and LSPC questions were not significantly different for both sexes.","['Heavy drinkers (≥11 Australian Standard Drinks (ASD) per occasion for males, ≥8 for females) from the second wave of a prospective cohort study were recruited via landline random digit dial from Melbourne in 2012']","['total consumption (n\xa0=\xa0127) or LSPC questions', 'Question Type and Order']","['total consumption and LSPC questions', 'Mean peak consumption', 'Peak Consumption of Risky Drinking Events']","[{'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.0288463,"Irrespective of question order, consumption amounts for total consumption and LSPC questions were not significantly different for both sexes.","[{'ForeName': 'Jun-Ting', 'Initials': 'JT', 'LastName': 'Yeung', 'Affiliation': 'Burnet Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Livingston', 'Affiliation': 'Centre for Alcohol Policy Research, La Trobe University, Bundoora, VIC, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Callinan', 'Affiliation': 'Centre for Alcohol Policy Research, La Trobe University, Bundoora, VIC, Australia.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Wright', 'Affiliation': 'Burnet Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Kuntsche', 'Affiliation': 'Centre for Alcohol Policy Research, La Trobe University, Bundoora, VIC, Australia.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Room', 'Affiliation': 'Centre for Alcohol Policy Research, La Trobe University, Bundoora, VIC, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dietze', 'Affiliation': 'Burnet Institute, Melbourne, VIC, Australia.'}]","Alcohol and alcoholism (Oxford, Oxfordshire)",['10.1093/alcalc/agaa076']
2420,32785589,"A Randomized, Double-blind, Multicenter Trial Comparing Efficacy and Safety of Imipenem/Cilastatin/Relebactam Versus Piperacillin/Tazobactam in Adults With Hospital-acquired or Ventilator-associated Bacterial Pneumonia (RESTORE-IMI 2 Study).","BACKGROUND


Imipenem combined with the β-lactamase inhibitor relebactam has broad antibacterial activity, including against carbapenem-resistant gram-negative pathogens. We evaluated efficacy and safety of imipenem/cilastatin/relebactam in treating hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP).
METHODS


This was a randomized, controlled, double-blind phase 3 trial. Adults with HABP/VABP were randomized 1:1 to imipenem/cilastatin/relebactam 500 mg/500 mg/250 mg or piperacillin/tazobactam 4 g/500 mg, intravenously every 6 hours for 7-14 days. The primary endpoint was day 28 all-cause mortality in the modified intent-to-treat (MITT) population (patients who received study therapy, excluding those with only gram-positive cocci at baseline). The key secondary endpoint was clinical response 7-14 days after completing therapy in the MITT population.
RESULTS


Of 537 randomized patients (from 113 hospitals in 27 countries), the MITT population comprised 264 imipenem/cilastatin/relebactam and 267 piperacillin/tazobactam patients; 48.6% had ventilated HABP/VABP, 47.5% APACHE II score ≥15, 24.7% moderate/severe renal impairment, 42.9% were ≥65 years old, and 66.1% were in the intensive care unit. The most common baseline pathogens were Klebsiella pneumoniae (25.6%) and Pseudomonas aeruginosa (18.9%). Imipenem/cilastatin/relebactam was noninferior (P < .001) to piperacillin/tazobactam for both endpoints: day 28 all-cause mortality was 15.9% with imipenem/cilastatin/relebactam and 21.3% with piperacillin/tazobactam (difference, -5.3% [95% confidence interval {CI}, -11.9% to 1.2%]), and favorable clinical response at early follow-up was 61.0% and 55.8%, respectively (difference, 5.0% [95% CI, -3.2% to 13.2%]). Serious adverse events (AEs) occurred in 26.7% of imipenem/cilastatin/relebactam and 32.0% of piperacillin/tazobactam patients; AEs leading to treatment discontinuation in 5.6% and 8.2%, respectively; and drug-related AEs (none fatal) in 11.7% and 9.7%, respectively.
CONCLUSIONS


Imipenem/cilastatin/relebactam is an appropriate treatment option for gram-negative HABP/VABP, including in critically ill, high-risk patients.
CLINICAL TRIALS REGISTRATION


NCT02493764.",2020,"Serious adverse events (AEs) occurred in 26.7% of imipenem/cilastatin/relebactam and 32.0% of piperacillin/tazobactam patients; AEs leading to treatment discontinuation in 5.6% and 8.2%, respectively; and drug-related AEs (none fatal) in 11.7% and 9.7%, respectively.
","['Adults With Hospital-acquired or Ventilator-associated Bacterial Pneumonia (RESTORE-IMI 2 Study', 'patients; 48.6% had ventilated HABP/VABP, 47.5% APACHE II score ≥15, 24.7% moderate/severe renal impairment, 42.9% were ≥65 years old, and 66.1% were in the intensive care unit', 'Adults with HABP/VABP', '537 randomized patients (from 113 hospitals in 27 countries']","['imipenem/cilastatin/relebactam 500 mg/500 mg/250 mg or piperacillin/tazobactam', 'imipenem/cilastatin', 'Imipenem/cilastatin/relebactam', 'piperacillin/tazobactam', 'Imipenem/Cilastatin/Relebactam Versus Piperacillin/Tazobactam', 'imipenem/cilastatin/relebactam', 'imipenem/cilastatin/relebactam and 267 piperacillin/tazobactam']","['Serious adverse events (AEs', 'efficacy and safety', 'day 28 all-cause mortality', 'cause mortality', 'favorable clinical response']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0456393', 'cui_str': 'Hospital acquired'}, {'cui': 'C2189270', 'cui_str': 'VABP'}, {'cui': 'C0340305', 'cui_str': 'Myocardial Infarction, Inferior Wall'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4727976', 'cui_str': 'Ventilated HABP'}, {'cui': 'C0489438', 'cui_str': 'APACHE II score'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C4517773', 'cui_str': '42.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0020933', 'cui_str': 'Imipenem'}, {'cui': 'C0008777', 'cui_str': 'Cilastatin'}, {'cui': 'C4317244', 'cui_str': 'Relebactam'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0250480', 'cui_str': 'Piperacillin and tazobactam'}, {'cui': 'C4517672', 'cui_str': '267'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",537.0,0.763867,"Serious adverse events (AEs) occurred in 26.7% of imipenem/cilastatin/relebactam and 32.0% of piperacillin/tazobactam patients; AEs leading to treatment discontinuation in 5.6% and 8.2%, respectively; and drug-related AEs (none fatal) in 11.7% and 9.7%, respectively.
","[{'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Titov', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk, Ukraine.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Wunderink', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Roquilly', 'Affiliation': 'EA3826 Thérapeutiques Anti-Infectieuses, Institut de Recherche en Santé 2 Nantes Biotech, Université, de Nantes, Nantes, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rodríguez Gonzalez', 'Affiliation': 'Department of Intensive Care, Hospital Civil de Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'David-Wang', 'Affiliation': 'Department of Medicine & Philippine General Hospital, Division of Pulmonary Medicine, University of the Philippines, Manila, Philippines.'}, {'ForeName': 'Helen W', 'Initials': 'HW', 'LastName': 'Boucher', 'Affiliation': 'Division of Geographic Medicine and Infectious Diseases, Tufts Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Keith S', 'Initials': 'KS', 'LastName': 'Kaye', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Losada', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Jiejun', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Tipping', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Rizk', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Munjal', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Brown', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Young', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Kartsonis', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Joan R', 'Initials': 'JR', 'LastName': 'Butterton', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Paschke', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Luke F', 'Initials': 'LF', 'LastName': 'Chen', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc, Kenilworth, New Jersey, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa803']
2421,32785614,Efficacy and Safety of PCSK9 Inhibition With Evolocumab in Reducing Cardiovascular Events in Patients With Metabolic Syndrome Receiving Statin Therapy: Secondary Analysis From the FOURIER Randomized Clinical Trial.,"Importance


The PCSK9 inhibitor evolocumab reduced low-density lipoprotein cholesterol and cardiovascular events in the FOURIER randomized clinical trial. Patients with metabolic syndrome (MetS) are at increased cardiovascular risk.
Objective


To investigate outcomes with evolocumab in patients with and without MetS.
Design, Setting, and Participants


The FOURIER trial randomized patients worldwide with stable atherosclerotic cardiovascular disease receiving statin to evolocumab vs placebo with follow-up for a median of 2.2 years. Data were collected February 2013 to November 2016. For this prespecified analysis, patients with the requisite data were stratified based on the National Cholesterol Education Program Adult Treatment Panel III MetS criteria; in secondary analyses, patients were further substratified by diabetes at baseline. Analysis was intention to treat. Analysis began March 2018 and ended April 2020.
Interventions


Patients were randomized to evolocumab or placebo.
Main Outcomes and Measures


The primary end point was cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary end point was cardiovascular death, myocardial infarction, or stroke.
Results


Of 27 342 patients (mean [SD] age, 63 [9] years; 20 623 men [75.4%]) included in this analysis, 16 361 (59.8%) with baseline MetS were, when compared with patients without MetS, at higher risk of cardiovascular events (adjusted hazard ratio [95% CI], 1.31 [1.18-1.46]; P < .001 for the primary and 1.38 [1.20-1.57]; P < .001 for the key secondary end point). Evolocumab reduced low-density lipoprotein cholesterol similarly in patients with MetS (median [interquartile range], 92 [79-109] mg/dL vs 30 [19-48] mg/dL; P < .001) and without MetS (median [interquartile range], 92 [81-108] mg/dL vs 29 [18-44] mg/dl; P < .001). For the primary end point, the hazard ratios (95% CI) with evolocumab vs placebo were 0.83 (0.76-0.91) and 0.89 (0.79-1.01) in patients with and without MetS (P for interaction = .39). For the key secondary end point, the corresponding hazard ratios (95% CIs) were 0.76 (0.68-0.86) and 0.86 (0.74-1.01) (P for interaction = .23), respectively. Evolocumab did not increase the risk of new-onset diabetes or other major safety outcomes including worsening glycemic control, compared with placebo in patients with MetS.
Conclusions and Relevance


Patients with atherosclerotic cardiovascular disease and MetS have substantial residual risk of cardiovascular events despite statin therapy. Evolocumab significantly reduced low-density lipoprotein cholesterol and cardiovascular risk in patients with MetS without increasing new-onset diabetes, worsening glycemic control, or other major safety events. These data suggest the addition of evolocumab to statin therapy in patients with atherosclerotic cardiovascular disease and MetS is safe and efficacious to reduce residual cardiovascular risk.
Trial Registration


ClinicalTrials.gov Identifier: NCT01764633.",2020,"Evolocumab did not increase the risk of new-onset diabetes or other major safety outcomes including worsening glycemic control, compared with placebo in patients with MetS.
Conclusions and Relevance


Patients with atherosclerotic cardiovascular disease and MetS have substantial residual risk of cardiovascular events despite statin therapy.","['patients with the requisite data were stratified based on the National Cholesterol Education Program Adult Treatment Panel III MetS criteria; in secondary analyses, patients were further substratified by diabetes at baseline', 'Patients With Metabolic Syndrome Receiving Statin Therapy', 'Patients with metabolic syndrome (MetS', 'patients with MetS without increasing new-onset diabetes', 'with follow-up for a median of 2.2 years', 'patients with atherosclerotic cardiovascular disease and MetS', 'patients with and without MetS.\nDesign, Setting, and Participants\n\n\nThe FOURIER trial randomized patients worldwide with stable atherosclerotic cardiovascular disease receiving statin to', 'Data were collected February 2013 to November 2016']","['evolocumab or placebo', 'evolocumab vs placebo', 'PCSK9 Inhibition With Evolocumab', 'PCSK9 inhibitor evolocumab', 'evolocumab', 'Evolocumab', 'placebo']","['risk of new-onset diabetes', 'hazard ratios', 'cardiovascular risk', 'cardiovascular death, myocardial infarction, or stroke', 'low-density lipoprotein cholesterol', 'cardiovascular events', 'cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization', 'low-density lipoprotein cholesterol and cardiovascular events', 'Cardiovascular Events', 'low-density lipoprotein cholesterol and cardiovascular risk']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]","[{'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1426592', 'cui_str': 'Proprotein convertase subtilisin/kexin type 9 gene'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C4521460', 'cui_str': 'PCSK9 inhibitor'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}]",27342.0,0.435523,"Evolocumab did not increase the risk of new-onset diabetes or other major safety outcomes including worsening glycemic control, compared with placebo in patients with MetS.
Conclusions and Relevance


Patients with atherosclerotic cardiovascular disease and MetS have substantial residual risk of cardiovascular events despite statin therapy.","[{'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Deedwania', 'Affiliation': 'University of California School of Medicine, San Francisco, Fresno.'}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Scheen', 'Affiliation': 'Department of Medicine, CHU Liège, Liège University, Liège, Belgium.'}, {'ForeName': 'Jolita', 'Initials': 'J', 'LastName': 'Badariene', 'Affiliation': 'Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Armando Lira', 'Initials': 'AL', 'LastName': 'Pineda', 'Affiliation': 'Amgen, Thousand Oaks, California.'}, {'ForeName': 'Narimon', 'Initials': 'N', 'LastName': 'Honarpour', 'Affiliation': 'Amgen, Thousand Oaks, California.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Keech', 'Affiliation': 'Sydney Medical School, NHMRC Clinical Trials Centre, University of Sydney, Australia.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Sever', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, United Kingdom.'}, {'ForeName': 'Terje R', 'Initials': 'TR', 'LastName': 'Pedersen', 'Affiliation': 'Oslo University Hospital, Ullevål and Medical Faculty, University of Oslo, Norway.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}]",JAMA cardiology,['10.1001/jamacardio.2020.3151']
2422,32383806,Linking data from a large clinical trial with the Australian Cerebral Palsy Register.,"AIM


To link data from a large maternal perinatal trial with the Australian Cerebral Palsy Register (ACPR) to identify children with cerebral palsy (CP).
METHOD


Deidentified data from the Australasian Collaborative Trial of Magnesium Sulphate (ACTOMgSO 4  ) and the ACPR were linked. Children born from 1996 to 2000 at Australian hospitals who survived and had 2-year paediatric assessments were included. Children identified with CP in: (1) both the ACTOMgSO 4  (2y) and the ACPR (5y), (2) the ACTOMgSO 4  only, and (3) the ACPR only were compared.
RESULTS


We included 913 children (492 males, 421 females; mean gestational age at birth 27.8wks [standard deviation 2.1wks]; range 23.0-40.0wks). Eighty-four children received a CP diagnosis: 35 by the ACTOMgSO 4  and the ACPR, 29 by the ACTOMgSO 4  only, and 20 by the ACPR only. The ACTOMgSO 4  diagnosed 76.2% (95% confidence interval [CI] 65.9-84.1) and the ACPR identified 65.5% (95% CI 54.7-74.9). Children born in states/territories with long-standing versus more recently established registers were more likely to be included on the ACPR (p<0.05).
INTERPRETATION


Linking deidentified perinatal trial data with the ACPR was achieved. Limitations of both strategies for identifying children with CP in this era (late 1990s and early 2000s) probably explain many of the differences observed, and inform future linkage studies and evaluations of CP-preventive interventions.
WHAT THIS PAPER ADDS


Randomized trial data were linked with the Australian Cerebral Palsy Register. Trial (2y) and register (up to 5y) diagnoses of cerebral palsy (CP) differed. States with long-standing registers were more likely to include children with CP.",2020,The ACTOMgSO 4  diagnosed 76.2% (95% confidence interval [CI] 65.9-84.1) and the ACPR identified 65.5% (95% CI 54.7-74.9).,"['children with cerebral palsy (CP', '913 children (492 males, 421 females; mean gestational age at birth 27.8wks', 'Children born from 1996 to 2000 at Australian hospitals who survived and had 2-year paediatric assessments were included']","['CP diagnosis', 'Magnesium Sulphate']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456129', 'cui_str': 'Length of gestation at birth'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}]",[],913.0,0.0522781,The ACTOMgSO 4  diagnosed 76.2% (95% confidence interval [CI] 65.9-84.1) and the ACPR identified 65.5% (95% CI 54.7-74.9).,"[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Shepherd', 'Affiliation': 'SA Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Mcintyre', 'Affiliation': 'Cerebral Palsy Alliance, Discipline of Child and Adolescent Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Smithers-Sheedy', 'Affiliation': 'Cerebral Palsy Alliance, Discipline of Child and Adolescent Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Pat', 'Initials': 'P', 'LastName': 'Ashwood', 'Affiliation': 'Discipline of Obstetrics and Gynaecology, Adelaide Medical School, The University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Sullivan', 'Affiliation': 'SA Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Te Velde', 'Affiliation': 'Cerebral Palsy Alliance, Discipline of Child and Adolescent Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Lex W', 'Initials': 'LW', 'LastName': 'Doyle', 'Affiliation': ""Victorian Infant Brain Studies, The Murdoch Children's Research Institute, Melbourne, Vic, Australia.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Makrides', 'Affiliation': 'SA Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Middleton', 'Affiliation': 'SA Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Crowther', 'Affiliation': 'Discipline of Obstetrics and Gynaecology, Adelaide Medical School, The University of Adelaide, Adelaide, SA, Australia.'}]",Developmental medicine and child neurology,['10.1111/dmcn.14556']
2423,32790718,Stepped-care versus treatment as usual in panic disorder: A randomized controlled trial.,"Stepped-care (SC) models for anxiety disorders are implemented on a large scale and are assumed to be as effective for the greater majority of patients as more intensive treatment schemes. To compare the outcomes of SC and international guideline-based treatment (Treatment as Usual: TAU) for panic disorder, a total of 128 patients were randomized to either SC or TAU (ratio 2: 1, respectively) using a computer generated algorithm. They were treated in four mental health care centres in the Netherlands after therapists had been trained in SC by a senior expert therapist. SC comprised 10-week guided self-help (pen-and-paper version) followed, if indicated, by 13-week manualized face-to-face cognitive behavioural therapy (CBT), with medication- if prescribed- kept constant. TAU consisted of 23-week regular face-to-face CBT (RCBT) with medication -when prescribed- also kept constant. The means of the attended sessions in the SC condition was 5.9 (SD = 4.8) for ITT and 9.6 (SD = 9.6) for the RCBT condition. The difference in the number of attended sessions between the conditions was significant (t(126) = -3.87, p < .001). Remission rates between treatment conditions did not differ significantly (SC: 44.5%; RCBT: 53.3%) and symptom reduction was similar. Stepping up SC treatment to face-to-face CBT showed a minimal additional effect. Importantly, drop-out rates differed significantly for the two conditions (SC: 48.2%; RCBT: 26.7%). SC was effective in the treatment of panic disorder in terms of symptom reduction and remission rate, but dropout rates were twice as high as those seen in RCBT, with the second phase of SC not substantially improving treatment response. However, SC required significantly less therapist contact time compared to RCBT, and more research is needed to explore predictors of success for guided self-help interventions to allow treatment intensity to be tailored to patients' needs and preferences.",2020,"SC was effective in the treatment of panic disorder in terms of symptom reduction and remission rate, but dropout rates were twice as high as those seen in RCBT, with the second phase of SC not substantially improving treatment response.","['They were treated in four mental health care centres in the Netherlands after therapists had been trained in SC by a senior expert therapist', 'panic disorder, a total of 128 patients']","['manualized face-to-face cognitive behavioural therapy (CBT), with medication- if prescribed- kept constant', 'SC and international guideline-based treatment (Treatment as Usual: TAU', 'SC', 'SC or TAU']","['therapist contact time', 'remission rate', 'symptom reduction', 'Remission rates', 'number of attended sessions']","[{'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",128.0,0.0572331,"SC was effective in the treatment of panic disorder in terms of symptom reduction and remission rate, but dropout rates were twice as high as those seen in RCBT, with the second phase of SC not substantially improving treatment response.","[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Kampman', 'Affiliation': 'Overwaal, Centre of Expertise for Anxiety Disorders, OCD, and PTSD part of Institute for Integrated Mental Health Care ""Pro Persona"", Nijmegen, The Netherlands.'}, {'ForeName': 'Anton J L M', 'Initials': 'AJLM', 'LastName': 'van Balkom', 'Affiliation': 'Amsterdam UMC, Psychiatry, Amsterdam Public Health Research Institute and GGZ inGeest, Specialized Mental Health Care, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Broekman', 'Affiliation': 'Bureau Bêta, Nijmegen, The Netherlands.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Verbraak', 'Affiliation': 'Behavioural Science Institute, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Gert-Jan', 'Initials': 'GJ', 'LastName': 'Hendriks', 'Affiliation': 'Overwaal, Centre of Expertise for Anxiety Disorders, OCD, and PTSD part of Institute for Integrated Mental Health Care ""Pro Persona"", Nijmegen, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0237061']
2424,32790725,"Effect of lipid-based nutrient supplement-Medium quantity on reduction of stunting in children 6-23 months of age in Sindh, Pakistan: A cluster randomized controlled trial.","BACKGROUND


Chronic childhood malnutrition, or stunting, remains a persistent barrier to achieve optimal cognitive development, child growth and ability to reach full potential. Almost half of children under-five years of age are stunted in the province of Sindh, Pakistan.
OBJECTIVE


The primary objective of this study was to test the hypothesis that the provision of lipid-based nutrient supplement-medium-quantity (LNS-MQ) known as Wawamum will result in a 10% reduction in risk of being stunted at the age of 24 months in the intervention group compared with the control group.
DESIGN


A cluster randomized controlled trial was conducted in Thatta and Sujawal districts of Sindh province, Pakistan. A total of 870 (419 in intervention; 451 in control) children between 6-18 months old were enrolled in the study. The unit of randomization was union council and considered as a cluster. A total of 12 clusters, 6 in each study group were randomly assigned to intervention and control group. All children received standard government health services, while children in the intervention group also received 50 grams/day of Wawamum.
RESULTS


Children who received Wawamum were found to have a significantly reduced risk of stunting (RR = 0.91, 95% CI; 0.88-0.94, p<0.001) and wasting (RR = 0.78, 95% CI; 0.67-0.92, p = 0.004) as compared to children who received the standard government health services. There was no evidence of a reduction in the risk of underweight (RR = 0.94, 95% CI; 0.85-1.04, p = 0.235) in the intervention group compared to the control group. Statistically significant reduction in anaemia in the intervention group was also found as compared to the control group (RR = 0.97, 95% CI; 0.94-0.99, p = 0.042). The subgroup analysis by age, showed intervention effect is significant in reduction of risk of stunting in younger children of aged 6-12 month (RR = 0.83, 95% CI; 0.81-0.86, p = <0.001) and their older peers aged 13-18 month- (RR = 0.90, 95% CI; 0.83-0.97, p = 0.008). The mean compliance of Wawamum was 60% among children.
CONCLUSIONS


The study confirmed that the provision of Wawamum to children 6-23 months of age is effective in reducing the risk of stunting, wasting and anaemia. This approach should be scaled up among the most food insecure areas/households with a high prevalence of stunting to achieve positive outcomes for nutrition and health. This study was registered at clinicaltrials.gov as NCT02422953. Clinical Trial Registration Number: NCT02422953.",2020,"The subgroup analysis by age, showed intervention effect is significant in reduction of risk of stunting in younger children of aged 6-12 month (RR = 0.83, 95% CI; 0.81-0.86, p = <0.001) and their older peers aged 13-18 month- (RR = 0.90, 95% CI; 0.83-0.97, p = 0.008).","['A total of 870 (419 in intervention; 451 in control) children between 6-18 months old were enrolled in the study', 'children 6-23 months of age in Sindh, Pakistan', 'Thatta and Sujawal districts of Sindh province, Pakistan']","['standard government health services', 'lipid-based nutrient supplement-medium-quantity (LNS-MQ', 'lipid-based nutrient supplement-Medium quantity']","['reduction of stunting', 'risk of underweight', 'mean compliance of Wawamum', 'risk of stunting', 'reduction of risk of stunting', 'anaemia', 'risk of stunting, wasting and anaemia']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}]",870.0,0.144529,"The subgroup analysis by age, showed intervention effect is significant in reduction of risk of stunting in younger children of aged 6-12 month (RR = 0.83, 95% CI; 0.81-0.86, p = <0.001) and their older peers aged 13-18 month- (RR = 0.90, 95% CI; 0.83-0.97, p = 0.008).","[{'ForeName': 'Gul Nawaz', 'Initials': 'GN', 'LastName': 'Khan', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Sumra', 'Initials': 'S', 'LastName': 'Kureishy', 'Affiliation': 'World Food Programme, Islamabad, Pakistan.'}, {'ForeName': 'Shabina', 'Initials': 'S', 'LastName': 'Ariff', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Arjumand', 'Initials': 'A', 'LastName': 'Rizvi', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Sajid', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Garzon', 'Affiliation': 'World Food Programme, Islamabad, Pakistan.'}, {'ForeName': 'Ali Ahmad', 'Initials': 'AA', 'LastName': 'Khan', 'Affiliation': 'World Food Programme, Islamabad, Pakistan.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'de Pee', 'Affiliation': 'World Food Programme, Rome, Italy.'}, {'ForeName': 'Sajid Bashir', 'Initials': 'SB', 'LastName': 'Soofi', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}]",PloS one,['10.1371/journal.pone.0237210']
2425,32790734,"Comparison of the MultiViewScope Stylet Scope and the direct laryngoscope with the Miller blade for the intubation in normal and difficult pediatric airways: A randomized, crossover, manikin study.","BACKGROUND


Managing difficult pediatric airway is challenging. The MultiViewScope (MVS) Stylet Scope is reported to be useful in difficult pediatric airway. In this randomized crossover study, we compared the effectiveness of the MVS Stylet Scope to a standard direct laryngoscope with Miller #1 blade in simulated normal and difficult airways.
METHODS


Fifteen expert anesthesiologists and Fifteen anesthesiology residents participated in the study. Participants were asked to perform intubation with the Airsim Baby manikin first, and then with the Airsim Pierre Robin manikin. Participants in each group used the intubation devices in a randomized order. The primary outcome was the time of successful intubation. The secondary outcomes were the force exerted on the incisors during intubation, Cormack-Lehane scale, the difficulty of intubation.
RESULTS


There were no differences between MVS Stylet Scope and Direct laryngoscope in the time of successful intubation by the expert anesthesiologists or the anesthesiology residents in a normal or difficult pediatric airway. MVS Stylet Scope significantly improved the force exerted on the incisors during intubation in the expert anesthesiologists or the anesthesiology residents in a normal or difficult pediatric airway. MVS Stylet Scope significantly improved Cormack-Lehane scale, and the difficulty of intubation with difficult pediatric airway situation in both expert anesthesiologists and anesthesiology residents.
CONCLUSIONS


Although less forces on the incisors and improved view of glottis were observed with the MVS Stylet Scope, MVS Stylet Scope did not shorten the time of intubation. The results of this study mean that the MVS Stylet Scope may be a less invasive airway devise than the direct laryngoscope with the Miller blade in the pediatric airway management. For the next step, we need to evaluate the MVS Stylet Scope in the real patients as an observational study.",2020,There were no differences between MVS Stylet Scope and Direct laryngoscope in the time of successful intubation by the expert anesthesiologists or the anesthesiology residents in a normal or difficult pediatric airway.,"['Fifteen expert anesthesiologists and Fifteen anesthesiology residents participated in the study', 'normal and difficult pediatric airways']","['MultiViewScope', 'direct laryngoscope with the Miller blade', 'MVS Stylet Scope']","['time of intubation', 'time of successful intubation', 'MultiViewScope (MVS', 'Cormack-Lehane scale', 'force exerted on the incisors during intubation, Cormack-Lehane scale, the difficulty of intubation']","[{'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0402830', 'cui_str': 'Miller'}, {'cui': 'C2948008', 'cui_str': 'Blade'}, {'cui': 'C0183663', 'cui_str': 'Stylet'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",,0.0337827,There were no differences between MVS Stylet Scope and Direct laryngoscope in the time of successful intubation by the expert anesthesiologists or the anesthesiology residents in a normal or difficult pediatric airway.,"[{'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Godai', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Moriyama', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Kanmura', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan.'}]",PloS one,['10.1371/journal.pone.0237593']
2426,32784613,"""Moving Forward with Life"": Acceptability of a Brief Alcohol Reduction Intervention for People Receiving Antiretroviral Therapy in South Africa.","BACKGROUND


In South Africa, interventions are needed to address the impact of hazardous drinking on antiretroviral therapy among people living with HIV (PLWH). Participant feedback about these interventions can identify ways to enhance their acceptability. We interviewed participants in a randomized controlled trial of a brief motivational interviewing and problem-solving therapy (MI-PST) intervention about their perceptions of this alcohol-reduction intervention.
METHODS


The trial was conducted in HIV treatment clinics operating from six hospitals in the Tshwane region of South Africa. We conducted qualitative in-depth interviews with a random selection of participants. Twenty-four participants were interviewed after the final intervention session and 25 at the six-month follow up.
RESULTS


Participants believed that it was acceptable to offer PLWH, an alcohol reduction intervention during HIV treatment. They described how the MI-PST intervention had helped them reduce their alcohol consumption. Intervention components providing information on the health benefits of reduced consumption and building problem-solving and coping skills were perceived as most beneficial. Despite these perceived benefits, participants suggested minor modifications to the dosage, content, and delivery of the intervention for greater acceptability and impact.
CONCLUSIONS


Findings highlight the acceptability and usefulness of this MI-PST intervention for facilitating reductions in alcohol consumption among PLWH.",2020,Intervention components providing information on the health benefits of reduced consumption and building problem-solving and coping skills were perceived as most beneficial.,"['People Receiving Antiretroviral Therapy in South Africa', 'people living with HIV (PLWH', 'HIV treatment clinics operating from six hospitals in the Tshwane region of South Africa']","['brief motivational interviewing and problem-solving therapy (MI-PST) intervention', 'alcohol-reduction intervention', 'MI-PST intervention', 'Alcohol Reduction Intervention']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454727', 'cui_str': 'Region of South Africa'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",[],24.0,0.0743292,Intervention components providing information on the health benefits of reduced consumption and building problem-solving and coping skills were perceived as most beneficial.,"[{'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Myers', 'Affiliation': 'Alcohol, Tobacco and Other Drug Research Unit, South African Medical Research Council, Tygerberg 7505, South Africa.'}, {'ForeName': 'Charles D H', 'Initials': 'CDH', 'LastName': 'Parry', 'Affiliation': 'Alcohol, Tobacco and Other Drug Research Unit, South African Medical Research Council, Tygerberg 7505, South Africa.'}, {'ForeName': 'Neo K', 'Initials': 'NK', 'LastName': 'Morojele', 'Affiliation': 'Alcohol, Tobacco and Other Drug Research Unit, South African Medical Research Council, Tygerberg 7505, South Africa.'}, {'ForeName': 'Sebenzile', 'Initials': 'S', 'LastName': 'Nkosi', 'Affiliation': 'Alcohol, Tobacco and Other Drug Research Unit, South African Medical Research Council, Tygerberg 7505, South Africa.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Shuper', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, Toronto, ON M5T1R8, Canada.'}, {'ForeName': 'Connie T', 'Initials': 'CT', 'LastName': 'Kekwaletswe', 'Affiliation': 'Alcohol, Tobacco and Other Drug Research Unit, South African Medical Research Council, Tygerberg 7505, South Africa.'}, {'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Sorsdahl', 'Affiliation': 'Alan J. Flisher Centre for Public Mental Health, Department of Psychiatry & Mental Health, University of Cape Town, Cape Town 7701, South Africa.'}]",International journal of environmental research and public health,['10.3390/ijerph17165706']
2427,32784945,Tensile Strength and Failure Types of Direct and Indirect Resin Composite Copings for Perio-Overdentures Luted Using Different Adhesive Cementation Modalities.,"Perio-overdenture design helps to reduce periodontal diseases and secondary caries on abutment teeth. Composite copings can be cemented adhesively to the abutment teeth with different techniques. In this study, direct/indirect resin composite copings for perio-overdentures, luted using different adhesive cementation modalities were compared. Human teeth (N = 40) were prepared to receive spherical attachment copings and randomly divided into four groups: (1) resin-composite copings bonded directly (DC), (2) composite copings made indirectly, luted with dual-polymerized resin cement (ICV), (3) composite copings made indirectly, bonded with resin composite (ICT), (4) composite copings made indirectly, bonded with resin composite after the immediate dentin sealing method (IDS). Specimens were tested for tensile failure and one-way ANOVA (alpha = 0.05) was performed and the two-parameter Weibull modulus, scale ( m ) and shape ( 0 ) were calculated. Mean tensile load (N) was significantly higher for Group IDS (238 ± 81) than for the other groups (144 ± 53-184 ± 46) ( p  < 0.05). Group IDS (0.54 ± 0.25 mm) showed significantly higher deformation (mm) than other groups (0.2 ± 0.1-0.32 ± 0.15) ( p  < 0.05). Weibull distribution presented lower shape ( 0 ) for DC (3.33) compared to other groups (3.57-4.99). Cohesive coping failures were more frequent in Group IDS (60%) and mixed failures in other groups (40-60%). In conclusion, IDS copings could be preferred over other fabrication and adhesion modalities.",2020,Mean tensile load (N) was significantly higher for Group IDS (238 ± 81) than for the other groups (144 ± 53-184 ± 46) ( p  < 0.05).,"['Human teeth (N = 40', 'Perio-Overdentures Luted']","['resin-composite copings bonded directly (DC), (2) composite copings made indirectly, luted with dual-polymerized resin cement (ICV), (3) composite copings made indirectly, bonded with resin composite (ICT), (4) composite copings made indirectly, bonded with resin composite after the immediate dentin sealing method (IDS', 'spherical attachment copings']","['Cohesive coping failures', 'Mean tensile load (N']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0011459', 'cui_str': 'Overlay denture'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}]","[{'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0314672', 'cui_str': 'Polymerization'}, {'cui': 'C0376523', 'cui_str': 'Resin Cement'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",40.0,0.0293639,Mean tensile load (N) was significantly higher for Group IDS (238 ± 81) than for the other groups (144 ± 53-184 ± 46) ( p  < 0.05).,"[{'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Cesca', 'Affiliation': 'Laboratory of Physiology and Biomechanics of the Masticatory System, Clinic for Masticatory Disorders, Center for Dental and Oral Medicine, University of Zurich, 8032 Zurich, Switzerland.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Colombo', 'Affiliation': 'Laboratory of Physiology and Biomechanics of the Masticatory System, Clinic for Masticatory Disorders, Center for Dental and Oral Medicine, University of Zurich, 8032 Zurich, Switzerland.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Ernst', 'Affiliation': 'Clinic for Reconstructive Dentistry, Division of Dental Biomaterials, Center for Dental and Oral Medicine, University of Zürich, 8032 Zurich, Switzerland.'}, {'ForeName': 'Luigi Maria', 'Initials': 'LM', 'LastName': 'Gallo', 'Affiliation': 'Laboratory of Physiology and Biomechanics of the Masticatory System, Clinic for Masticatory Disorders, Center for Dental and Oral Medicine, University of Zurich, 8032 Zurich, Switzerland.'}, {'ForeName': 'Mutlu', 'Initials': 'M', 'LastName': 'Özcan', 'Affiliation': 'Clinic for Reconstructive Dentistry, Division of Dental Biomaterials, Center for Dental and Oral Medicine, University of Zürich, 8032 Zurich, Switzerland.'}]","Materials (Basel, Switzerland)",['10.3390/ma13163517']
2428,32784956,Pilot Testing of a Nudge-Based Digital Intervention (Welbot) to Improve Sedentary Behaviour and Wellbeing in the Workplace.,"Welbot is a nudge-based digital intervention that aims to reduce sedentary behaviour and improve physical and mental wellbeing at work. The purpose of this study was to pilot test the Welbot intervention. Forty-one (6M/35F) University staff ( M  age = 43-years) participated in this study, which was a single arm repeated measures trial conducted over three weeks of intervention. The primary outcome was sedentary behaviour (measured subjectively and objectively) and secondary outcomes included: mental wellbeing, procrastination, depression, anxiety and stress, and work engagement. A subset of participants ( n  = 6) wore an ActivPAL to objectively measure activity data, while another subset of participants ( n  = 6) completed a qualitative semi-structured interview to ascertain experiences of using Welbot. Following the intervention, a Friedman non-parametric test revealed that participants self-reported significantly less time sitting and more time standing and objectively recorded more steps at the week-1 follow-up. A series of paired  t -tests exhibited that changes in all secondary outcomes were in the expected direction. However, only improvements in depression, anxiety, and stress were significant. After using Welbot, thematic analysis demonstrated that participants perceived they had a positive behaviour change, increased awareness of unhealthy behaviours at work, and provided suggestions for intervention improvement. Overall, findings provided indications of the potential positive impact Welbot may have on employees' wellbeing, however, limitations are noted. Recommendations for intervention improvement including personalisation (e.g., individual preferences for nudges and the option to sync Welbot with online calendars) and further research into how users engage with Welbot are provided.",2020,"Following the intervention, a Friedman non-parametric test revealed that participants self-reported significantly less time sitting and more time standing and objectively recorded more steps at the week-1 follow-up.","['Forty-one (6M/35F', 'University staff ( M  age']",['Nudge-Based Digital Intervention (Welbot'],"['sedentary behaviour and improve physical and mental wellbeing', 'depression, anxiety, and stress', 'time sitting and more time standing', 'Sedentary Behaviour and Wellbeing', 'sedentary behaviour (measured subjectively and objectively) and secondary outcomes included: mental wellbeing, procrastination, depression, anxiety and stress, and work engagement', 'positive behaviour change, increased awareness of unhealthy behaviours']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0871142', 'cui_str': 'Procrastination'}, {'cui': 'C4505268', 'cui_str': 'Employee Engagement'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]",,0.0571395,"Following the intervention, a Friedman non-parametric test revealed that participants self-reported significantly less time sitting and more time standing and objectively recorded more steps at the week-1 follow-up.","[{'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Haile', 'Affiliation': 'Psychological Sciences and Health, Graham Hills Building, University of Strathclyde, Glasgow G1 1QX, Scotland, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Kirk', 'Affiliation': 'Psychological Sciences and Health, Graham Hills Building, University of Strathclyde, Glasgow G1 1QX, Scotland, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Cogan', 'Affiliation': 'Psychological Sciences and Health, Graham Hills Building, University of Strathclyde, Glasgow G1 1QX, Scotland, UK.'}, {'ForeName': 'Xanne', 'Initials': 'X', 'LastName': 'Janssen', 'Affiliation': 'Psychological Sciences and Health, Graham Hills Building, University of Strathclyde, Glasgow G1 1QX, Scotland, UK.'}, {'ForeName': 'Ann-Marie', 'Initials': 'AM', 'LastName': 'Gibson', 'Affiliation': 'Psychological Sciences and Health, Graham Hills Building, University of Strathclyde, Glasgow G1 1QX, Scotland, UK.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'MacDonald', 'Affiliation': 'Psychological Sciences and Health, Graham Hills Building, University of Strathclyde, Glasgow G1 1QX, Scotland, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17165763']
2429,32784959,"Immediate and Short-Term Effects of Upper Cervical High-Velocity, Low-Amplitude Manipulation on Standing Postural Control and Cervical Mobility in Chronic Nonspecific Neck Pain: A Randomized Controlled Trial.","This study aimed to determine the immediate and short-term effects of a single upper cervical high-velocity, low-amplitude (HVLA) manipulation on standing postural control and cervical mobility in chronic nonspecific neck pain (CNSNP). A double-blinded, randomized placebo-controlled trial was performed. Forty-four patients with CNSNP were allocated to the experimental group ( n  = 22) or control group ( n  = 22). All participants were assessed before and immediately after the intervention, with a follow-up on the 7th and 15th days. In each evaluation, we assessed global and specific stabilometric parameters to analyze standing postural balance and performed the cervical flexion-rotation test (CFRT) to analyze upper cervical mobility. We obtained statistically significant differences, with a large effect size, in the limited cervical rotation and global stabilometric parameters. Upper cervical HVLA manipulation produced an improvement in the global stabilometric parameters, significantly decreasing the mean values of velocity, surface, path length, and pressure in all assessments ( p  < 0.001; ƞ 2  p  = 0.323-0.856), as well as significantly decreasing the surface length ratio (L/S) on the 7th (-0.219 1/mm;  p  = 0.008; 95% confidence interval (CI): 0.042-0.395) and 15th days (-0.447 1/mm;  p  < 0.001; 95% CI: 0.265-0.629). Limited cervical rotation values increased significantly immediately after manipulation (7.409°;  p  < 0.001; 95% CI: 6.131-8.687) and were maintained during follow-up ( p  < 0.001). These results show that a single upper cervical HVLA manipulation produces an improvement in standing postural control and increases the rotational range of motion (ROM) in the upper cervical spine in patients with CNSNP.",2020,"Upper cervical HVLA manipulation produced an improvement in the global stabilometric parameters, significantly decreasing the mean values of velocity, surface, path length, and pressure in all assessments ( p  < 0.001; ƞ 2  p  = 0.323-0.856), as well as significantly decreasing the surface length ratio (L/S) on the 7th (-0.219 1/mm;  p  = 0.008; 95% confidence interval (CI): 0.042-0.395) and 15th days (-0.447 1/mm;  p  < 0.001; 95% CI: 0.265-0.629).","['Chronic Nonspecific Neck Pain', 'patients with CNSNP', 'Forty-four patients with CNSNP', 'chronic nonspecific neck pain (CNSNP']","['Upper Cervical High-Velocity, Low-Amplitude Manipulation', 'cervical flexion-rotation test (CFRT', 'single upper cervical high-velocity, low-amplitude (HVLA) manipulation', 'placebo']","['rotational range of motion (ROM', 'Limited cervical rotation values', 'standing postural control', 'surface length ratio', 'Standing Postural Control and Cervical Mobility', 'limited cervical rotation and global stabilometric parameters', 'global stabilometric parameters', 'mean values of velocity, surface, path length, and pressure in all assessments']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0178091', 'cui_str': 'Rotational test'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",44.0,0.0975073,"Upper cervical HVLA manipulation produced an improvement in the global stabilometric parameters, significantly decreasing the mean values of velocity, surface, path length, and pressure in all assessments ( p  < 0.001; ƞ 2  p  = 0.323-0.856), as well as significantly decreasing the surface length ratio (L/S) on the 7th (-0.219 1/mm;  p  = 0.008; 95% confidence interval (CI): 0.042-0.395) and 15th days (-0.447 1/mm;  p  < 0.001; 95% CI: 0.265-0.629).","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Gómez', 'Affiliation': 'Centro Fisioterapia y Osteopatía Osteofisio, 12006 Castellón, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Escribá', 'Affiliation': 'Clínica Fisioterapia y Osteopatia Pablo Escribá, Alboraya, 46120 Valencia, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Oliva-Pascual-Vaca', 'Affiliation': 'Department of Physiotherapy, Universidad de Sevilla, 41009 Sevilla, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Méndez-Sánchez', 'Affiliation': 'Department of Nursing and Physiotherapy, Universidad de Salamanca, 37007 Salamanca, Spain.'}, {'ForeName': 'Ana Silvia', 'Initials': 'AS', 'LastName': 'Puente-González', 'Affiliation': 'Department of Nursing and Physiotherapy, Universidad de Salamanca, 37007 Salamanca, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9082580']
2430,32784997,Soft Tissue Dimensions Following Tooth Extraction in the Posterior Maxilla: A Randomized Clinical Trial Comparing Alveolar Ridge Preservation to Spontaneous Healing.,"BACKGROUND


To assess the soft tissue dimension following tooth extraction and alveolar ridge preservation in the posterior maxilla compared to spontaneous healing.
METHODS


Thirty-five patients randomly assigned to alveolar ridge preservation (ARP) and spontaneous healing (SH) after maxillary molar extraction. The crestal, buccal, and palatal gingival thickness at 6 months was measured around virtually placed implant fixtures using superimposed cone-beam computed tomography and intraoral scan taken at 6 months. Buccal mucogingival junction (MGJ) level change over 6 months was estimated using intraoral scans obtained at suture-removal and 6 months.
RESULTS


The crestal gingiva was significantly thinner in group ARP (-1.16 mm) compared to group SH ( p  < 0.05). The buccal and palatal gingiva was significantly thinner at the implant shoulder (IS) level in group ARP (buccal: -0.75 mm; palatal: -0.85 mm) compared to group SH ( p  < 0.05). The thickness at 2 mm below the IS of both sides and the buccal MGJ level change were similar in both groups ( p  > 0.05).
CONCLUSIONS


ARP in the posterior maxilla resulted in a thinner soft tissue on top of and at the prospective level of the implant shoulder at 6 months. The buccal MGJ level changed minimal for 6 months in both groups.",2020,The buccal and palatal gingiva was significantly thinner at the implant shoulder (IS) level in group,"['Posterior Maxilla', 'Thirty-five patients randomly assigned to']",['alveolar ridge preservation (ARP) and spontaneous healing (SH) after maxillary molar extraction'],"['crestal gingiva', 'crestal, buccal, and palatal gingival thickness', 'Buccal mucogingival junction (MGJ) level change', 'buccal MGJ level change', 'buccal and palatal gingiva', 'buccal MGJ level']","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0447454', 'cui_str': 'Mucogingival junction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",35.0,0.0275548,The buccal and palatal gingiva was significantly thinner at the implant shoulder (IS) level in group,"[{'ForeName': 'Young Woo', 'Initials': 'YW', 'LastName': 'Song', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, Seoul 03722, Korea.'}, {'ForeName': 'Sung-Wook', 'Initials': 'SW', 'LastName': 'Yoon', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, Seoul 03722, Korea.'}, {'ForeName': 'Jae-Kook', 'Initials': 'JK', 'LastName': 'Cha', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, Seoul 03722, Korea.'}, {'ForeName': 'Ui-Won', 'Initials': 'UW', 'LastName': 'Jung', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, Seoul 03722, Korea.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'Jung', 'Affiliation': 'Clinic of Reconstructive Dentistry, Center of Dental Medicine, University of Zurich, 8032 Zurich, Switzerland.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Thoma', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, Seoul 03722, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9082583']
2431,32785636,Assessment of Relationship of Ketamine Dose With Magnetic Resonance Spectroscopy of Glx and GABA Responses in Adults With Major Depression: A Randomized Clinical Trial.,"Importance


A single subanesthetic dose of ketamine produces an antidepressant response in patients with major depressive disorder (MDD) within hours, but the mechanism of antidepressant effect is uncertain.
Objective


To evaluate whether ketamine dose and brain glutamate and glutamine (Glx) and γ-aminobutyric acid (GABA) level responses to ketamine are related to antidepressant benefit and adverse effects.
Design, Setting, and Participants


This randomized, parallel-group, triple-masked clinical trial included 38 physically healthy, psychotropic medication-free adult outpatients who were in a major depressive episode of MDD but not actively suicidal. The trial was conducted at Columbia University Medical Center. Data were collected from February 2012 to May 2015. Data analysis was conducted from January to March 2020.
Intervention


Participants received 1 dose of placebo or ketamine (0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg) intravenously during 40 minutes of a proton magnetic resonance spectroscopy scan that measured ventro-medial prefrontal cortex Glx and GABA levels in 13-minute data frames.
Main Outcomes and Measures


Clinical improvement was measured using a 22-item version of the Hamilton Depression Rating Scale (HDRS-22) 24 hours after ketamine was administered. Ketamine and metabolite blood levels were measured after the scan.
Results


A total of 38 individuals participated in the study, with a mean (SD) age of 38.6 (11.2) years, 23 (60.5%) women, and 25 (65.8%) White patients. Improvement in HDRS-22 score at 24 hours correlated positively with ketamine dose (t36 = 2.81; P = .008; slope estimate, 19.80 [95% CI, 5.49 to 34.11]) and blood level (t36 = 2.25; P = .03; slope estimate, 0.070 [95% CI, 0.007 to 0.133]). The lower the Glx response, the better the antidepressant response (t33 = -2.400; P = .02; slope estimate, -9.85 [95% CI, -18.2 to -1.50]). Although GABA levels correlated with Glx (t33 = 8.117; P < .001; slope estimate, 0.510 [95% CI, 0.382 to 0.638]), GABA response did not correlate with antidepressant effect. When both ketamine dose and Glx response were included in a mediation analysis model, ketamine dose was no longer associated with antidepressant effect, indicating that Glx response mediated the relationship. Adverse effects were related to blood levels in men only (t5 = 2.606; P = .048; estimated slope, 0.093 [95% CI, 0.001 to 0.186]), but Glx and GABA response were not related to adverse effects.
Conclusions and Relevance


In this study, intravenous ketamine dose and blood levels correlated positively with antidepressant response. The Glx response correlated inversely with ketamine dose and with antidepressant effect. Future studies are needed to determine whether the relationship between Glx level and antidepressant effect is due to glutamate or glutamine.
Trial Registration


ClinicalTrials.gov Identifier: NCT01558063.",2020,"Adverse effects were related to blood levels in men only (t5 = 2.606; P = .048; estimated slope, 0.093 [95% CI, 0.001 to 0.186]), but Glx and GABA response were not related to adverse effects.
","['38 individuals participated in the study, with a mean (SD) age of 38.6 (11.2) years, 23 (60.5%) women, and 25 (65.8', '38 physically healthy, psychotropic medication-free adult outpatients who were in a major depressive episode of MDD but not actively suicidal', 'White patients', 'patients with major depressive disorder (MDD', 'Adults With Major Depression']","['placebo or ketamine', 'Ketamine Dose With Magnetic Resonance Spectroscopy of Glx and GABA Responses', 'ketamine']","['Glx and GABA response', 'Ketamine and metabolite blood levels', 'antidepressant response', 'blood levels', 'brain glutamate and glutamine (Glx) and γ-aminobutyric acid (GABA) level responses', 'Adverse effects', 'HDRS-22 score', 'GABA response', '22-item version of the Hamilton Depression Rating Scale (HDRS-22', 'blood level', 'Glx response']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}]","[{'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}]",38.0,0.370157,"Adverse effects were related to blood levels in men only (t5 = 2.606; P = .048; estimated slope, 0.093 [95% CI, 0.001 to 0.186]), but Glx and GABA response were not related to adverse effects.
","[{'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Milak', 'Affiliation': 'Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'Rain', 'Initials': 'R', 'LastName': 'Rashid', 'Affiliation': 'Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'Zhengchao', 'Initials': 'Z', 'LastName': 'Dong', 'Affiliation': 'Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Kegeles', 'Affiliation': 'Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Grunebaum', 'Affiliation': 'Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'R Todd', 'Initials': 'RT', 'LastName': 'Ogden', 'Affiliation': 'Molecular Imaging and Neuropathology Division, The New York State Psychiatric Institute, New York.'}, {'ForeName': 'Xuejing', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Molecular Imaging and Neuropathology Division, The New York State Psychiatric Institute, New York.'}, {'ForeName': 'Stephanie T', 'Initials': 'ST', 'LastName': 'Mulhern', 'Affiliation': 'Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'Raymond F', 'Initials': 'RF', 'LastName': 'Suckow', 'Affiliation': 'Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Keilp', 'Affiliation': 'Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'Xiangling', 'Initials': 'X', 'LastName': 'Mao', 'Affiliation': 'Department of Radiology, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Dikoma C', 'Initials': 'DC', 'LastName': 'Shungu', 'Affiliation': 'Department of Radiology, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'J John', 'Initials': 'JJ', 'LastName': 'Mann', 'Affiliation': 'Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, New York.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.13211']
2432,32785654,Bone marrow metabolism is impaired in insulin resistance and improves after exercise training.,"CONTEXT


Exercise training improves bone mineral density, but little is known about the effects of training on bone marrow (BM) metabolism. BM insulin sensitivity has been suggested to play an important role in bone health and whole-body insulin sensitivity.
OBJECTIVE


To study the effects of exercise training on BM metabolism.
DESIGN


Randomized controlled trial.
SETTING


Clinical research center.
PARTICIPANTS


Sedentary healthy (n=28, 40-55 years, all males) and insulin resistant subjects (IR) (n=26, 43-55 years, males/females 16/10).
INTERVENTION


Two weeks of sprint interval training or moderate-intensity continuous training.
MAIN OUTCOME MEASURES


We measured femoral, lumbar and thoracic BM insulin-stimulated glucose uptake (GU) and fasting free fatty acid uptake (FFAU) using positron-emission tomography and bone turnover markers from plasma.
RESULTS


At baseline, GU was highest in lumbar, followed by thoracic and lowest in femoral BM (all p<0.0001). FFAU was higher in lumbar and thoracic than femoral BM (both p<0.0001). BM FFAU and femoral BM GU were higher in healthy compared to IR men and in females compared to males (all p<0.05). Training increased femoral BM GU similarly in all groups and decreased lumbar BM FFAU in males (all p<0.05). Osteocalcin and PINP were lower in IR than healthy men and correlated positively with femoral BM GU and glycemic status (all p<0.05).
CONCLUSIONS


BM metabolism differs regarding anatomical location. Short-term training improves BM GU and FFAU in healthy and IR subjects. Bone turnover rate is decreased in insulin resistance and associates positively with BM metabolism and glycemic control.",2020,"Osteocalcin and PINP were lower in IR than healthy men and correlated positively with femoral BM GU and glycemic status (all p<0.05).
","['Sedentary healthy (n=28, 40-55 years, all males) and insulin resistant subjects (IR) (n=26, 43-55 years, males/females 16/10', 'healthy and IR subjects']","['FFAU', 'exercise training', 'Exercise training', 'femoral BM', 'sprint interval training or moderate-intensity continuous training']","['bone mineral density', 'femoral BM GU', 'Osteocalcin and PINP', 'bone marrow (BM) metabolism', 'lumbar BM FFAU', 'femoral, lumbar and thoracic BM insulin-stimulated glucose uptake (GU) and fasting free fatty acid uptake (FFAU', 'BM FFAU and femoral BM GU', 'Bone turnover rate', 'BM GU and FFAU', 'femoral BM GU and glycemic status']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0231544', 'cui_str': 'Bone turnover rate'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.0163126,"Osteocalcin and PINP were lower in IR than healthy men and correlated positively with femoral BM GU and glycemic status (all p<0.05).
","[{'ForeName': 'Ronja', 'Initials': 'R', 'LastName': 'Ojala', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Kumail K', 'Initials': 'KK', 'LastName': 'Motiani', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Kaisa K', 'Initials': 'KK', 'LastName': 'Ivaska', 'Affiliation': 'Institute of Biomedicine, University of Turku, Turku, Finland.'}, {'ForeName': 'Milja', 'Initials': 'M', 'LastName': 'Arponen', 'Affiliation': 'Institute of Biomedicine, University of Turku, Turku, Finland.'}, {'ForeName': 'Jari-Joonas', 'Initials': 'JJ', 'LastName': 'Eskelinen', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Kirsi A', 'Initials': 'KA', 'LastName': 'Virtanen', 'Affiliation': 'Turku PET Centre, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Eliisa', 'Initials': 'E', 'LastName': 'Löyttyniemi', 'Affiliation': 'Department of Biostatistics, University of Turku, Turku, Finland.'}, {'ForeName': 'Marja A', 'Initials': 'MA', 'LastName': 'Heiskanen', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Mueez', 'Initials': 'M', 'LastName': 'U-Din', 'Affiliation': 'Turku PET Centre, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Pirjo', 'Initials': 'P', 'LastName': 'Nuutila', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Kari K', 'Initials': 'KK', 'LastName': 'Kalliokoski', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Jarna C', 'Initials': 'JC', 'LastName': 'Hannukainen', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa516']
2433,32785666,Venetoclax-rituximab ± bendamustine vs bendamustine-rituximab in relapsed/refractory follicular lymphoma: CONTRALTO.,"This open-label phase 2 study (CONTRALTO) assessed the safety and efficacy of BCL-2 inhibitor venetoclax (VEN) plus rituximab (R), and VEN plus bendamustine (B) and R, versus BR alone in relapsed/refractory follicular lymphoma. Patients in the chemotherapy-free arm (Arm A: VEN+R) received VEN 800 mg/d plus R 375 mg/m2 on days (D) 1, 8, 15, and 22 of cycle (C)1 and D1 of C4, C6, C8, C10, and C12. After a safety run-in with VEN 600 mg, patients in the chemotherapy-containing cohort were randomized to either VEN+BR (Arm B; VEN 800 mg/d for 1 year + 6 cycles BR [B 90 mg/m2 D1, 2 and R 375 mg/m2 D1]) or 6 cycles BR (Arm C). Overall, 163 patients were analyzed: 9 in safety run-in; 52, 51, and 51 in Arms A, B, and C, respectively. Complete metabolic/complete response rates were 17% (Arm A), 75% (Arm B), and 69% (Arm C). Of patients in Arm B, only 61% received ≥90% of the planned bendamustine dose versus 96% of patients in Arm C. More frequent hematologic toxicity resulted in more reduced dosing/treatment discontinuation in Arm B versus C. Rates of grade 3/4 adverse events were 51.9%, 93.9% and 60.0% in Arms A, B and C, respectively. VEN+BR led to increased toxicity and lower dose intensity of BR than in Arm C, but efficacy was similar. Optimizing dose and schedule to maintain BR dose intensity may improve efficacy and tolerability of VEN+BR, while VEN+R data warrant further study (NCT02187861; ClinicalTrials.gov).",2020,"More frequent hematologic toxicity resulted in more reduced dosing/treatment discontinuation in Arm B versus C. Rates of grade 3/4 adverse events were 51.9%, 93.9% and 60.0% in Arms A, B and C, respectively.","['163 patients were analyzed: 9 in safety run-in; 52, 51, and 51 in Arms A, B, and C, respectively', 'relapsed/refractory follicular lymphoma']","['planned bendamustine', 'BCL-2 inhibitor venetoclax (VEN) plus rituximab (R), and VEN plus bendamustine (B) and R, versus BR alone', 'VEN+BR', 'VEN', 'Venetoclax-rituximab ± bendamustine vs bendamustine-rituximab']","['efficacy and tolerability', 'toxicity', 'hematologic toxicity', 'Complete metabolic/complete response rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}]","[{'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C4319834', 'cui_str': 'B-cell lymphoma 2 inhibitor'}, {'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",163.0,0.0620375,"More frequent hematologic toxicity resulted in more reduced dosing/treatment discontinuation in Arm B versus C. Rates of grade 3/4 adverse events were 51.9%, 93.9% and 60.0% in Arms A, B and C, respectively.","[{'ForeName': 'Pier Luigi', 'Initials': 'PL', 'LastName': 'Zinzani', 'Affiliation': 'Institute of Hematology ""Lorenzo e Ariosto Seragnoli"", Bologna, Italy.'}, {'ForeName': 'Ian W', 'Initials': 'IW', 'LastName': 'Flinn', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, Tennessee, United States.'}, {'ForeName': 'Sam L S', 'Initials': 'SLS', 'LastName': 'Yuen', 'Affiliation': 'Calvary Mater Newcastle, Waratah, Australia.'}, {'ForeName': 'Max S', 'Initials': 'MS', 'LastName': 'Topp', 'Affiliation': 'Universitätsklinikum Würzburg, Würzburg, Germany.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Rusconi', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Fleury', 'Affiliation': 'Hôpital Maisonneuve-Rosemonty, Montreal, Canada.'}, {'ForeName': 'Katell', 'Initials': 'K', 'LastName': 'Le Dû', 'Affiliation': 'Hematology department, Clinique Victor Hugo, le Mans, LE MANS, France.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Arthur', 'Affiliation': 'Royal North Shore Hospital, Sydney, Australia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pro', 'Affiliation': 'Northwestern University, Chicago, Illinois, United States.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Gritti', 'Affiliation': 'Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Crump', 'Affiliation': 'Princess Margaret Hospital, Toronto, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Petrich', 'Affiliation': 'Abbvie.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Samineni', 'Affiliation': 'Genentech Inc.'}, {'ForeName': 'Arijit', 'Initials': 'A', 'LastName': 'Sinha', 'Affiliation': 'Roche Products Ltd.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Punnoose', 'Affiliation': 'Genentech, Inc., S. San Francisco, California, United States.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Szafer-Glusman', 'Affiliation': 'Genentech, Inc, South San Francisco, California, United States.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Spielewoy', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Mobasher', 'Affiliation': 'Corvus, Burlingame, California, United States.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Humphrey', 'Affiliation': 'Roche, Welwyn Garden City, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kornacker', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hiddemann', 'Affiliation': 'University of Munich, Munich, Germany.'}]",Blood,['10.1182/blood.2020005588']
2434,32785689,Markers of Iron Flux during Testosterone-Mediated Erythropoiesis in Older Men with Unexplained or Iron-Deficiency Anemia.,"CONTEXT


Testosterone treatment of hypogonadal men improves their hemoglobin, but the mechanism is not understood.
OBJECTIVE


To investigate possible mechanisms by which testosterone stimulates erythropoiesis in hypogonadal older men with unexplained or iron-deficiency anemia.
DESIGN


The Anemia Trial of The Testosterone Trials, a placebo-controlled study in older, hypogonadal men.
SETTING


Twelve academic medical centers.
PARTICIPANTS


95 hypogonadal men (testosterone <275 ng/mL) ≥65 years with anemia (hemoglobin <12.7 g/dL). They were classified as having unexplained (58) or iron deficiency anemia (37).
INTERVENTION


Testosterone or placebo gel for one year.
MAIN OUTCOME MEASURES


Markers of iron metabolism during the first three months of treatment.
RESULTS


Testosterone replacement significantly (p<0.001) increased hemoglobin in the 58 men who had unexplained anemia (adjusted mean difference 0.58 g/dL; 95% CI 0.31-0.85). Testosterone replacement tended to increase hemoglobin in the 37 men who had iron deficiency (0.38 g/dL; -0.19,0.95), but the response was more variable and not statistically significant (p=0.19). In men with unexplained anemia, testosterone replacement suppressed hepcidin [-8.2 ng/mL (-13.7, -2.7) p=0.004] and ferritin [-19.6 µg/L (-32.8, -6.3) p =0.004], but in men with iron deficiency, testosterone replacement did not. The decrease in hepcidin was moderately correlated with the increase in hemoglobin in the men with unexplained anemia (correlation coefficient -0.35, p = 0.01) but not in those with iron deficiency anemia (correlation coefficient -0.07, p = 0.73 ).
CONCLUSIONS


Testosterone replacement of older hypogonadal men with unexplained anemia stimulates erythropoiesis associated with increased iron mobilization. This effect appears to be attenuated by iron deficiency.",2020,"RESULTS


Testosterone replacement significantly (p<0.001) increased hemoglobin in the 58 men who had unexplained anemia (adjusted mean difference 0.58 g/dL; 95% CI 0.31-0.85).","['older, hypogonadal men', 'older hypogonadal men with unexplained anemia stimulates erythropoiesis', 'They were classified as having unexplained (58) or iron deficiency anemia (37', 'hypogonadal older men with unexplained or iron-deficiency anemia', 'Older Men with Unexplained or Iron-Deficiency Anemia', 'hypogonadal men', 'Twelve academic medical centers', '95 hypogonadal men (testosterone <275 ng/mL) ≥65 years with anemia (hemoglobin <12.7 g/dL']","['Testosterone-Mediated Erythropoiesis', 'testosterone', 'Testosterone replacement', 'Testosterone or placebo gel', 'placebo']","['hemoglobin', 'Markers of iron metabolism', 'unexplained anemia', 'hepcidin']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517546', 'cui_str': '12.7'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}]",95.0,0.520846,"RESULTS


Testosterone replacement significantly (p<0.001) increased hemoglobin in the 58 men who had unexplained anemia (adjusted mean difference 0.58 g/dL; 95% CI 0.31-0.85).","[{'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Artz', 'Affiliation': 'City of Hope, Department of Hematology and Hematopoietic Cell Transplantation, Duarte, CA.'}, {'ForeName': 'Alisa J', 'Initials': 'AJ', 'LastName': 'Stephens-Shields', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Shalender', 'Initials': 'S', 'LastName': 'Bhasin', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Ellenberg', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Harvey J', 'Initials': 'HJ', 'LastName': 'Cohen', 'Affiliation': 'Duke University Medical Center, Center for the Study of Aging, Durham, NC.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Snyder', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa521']
2435,32786188,Compression Therapy to Prevent Recurrent Cellulitis of the Leg.,"BACKGROUND


Chronic edema of the leg is a risk factor for cellulitis. Daily use of compression garments on the leg has been recommended to prevent the recurrence of cellulitis, but there is limited evidence from trials regarding its effectiveness.
METHODS


In this single-center, randomized, nonblinded trial, we assigned participants with chronic edema of the leg and recurrent cellulitis, in a 1:1 ratio, to receive leg compression therapy plus education on cellulitis prevention (compression group) or education alone (control group). Follow-up occurred every 6 months for up to 3 years or until 45 episodes of cellulitis had occurred in the trial. The primary outcome was the recurrence of cellulitis. Participants in the control group who had an episode of cellulitis crossed over to the compression group. Secondary outcomes included cellulitis-related hospital admission and quality-of-life assessments.
RESULTS


A total of 183 patients were screened, and 84 were enrolled; 41 participants were assigned to the compression group, and 43 to the control group. At the time of a planned interim analysis, when 23 episodes of cellulitis had occurred, 6 participants (15%) in the compression group and 17 (40%) in the control group had had an episode of cellulitis (hazard ratio, 0.23; 95% confidence interval [CI], 0.09 to 0.59; P = 0.002; relative risk [post hoc analysis], 0.37; 95% CI, 0.16 to 0.84; P = 0.02), and the trial was stopped for efficacy. A total of 3 participants (7%) in the compression group and 6 (14%) in the control group were hospitalized for cellulitis (hazard ratio, 0.38; 95% CI, 0.09 to 1.59). Most quality-of-life outcomes did not differ between the two groups. No adverse events occurred during the trial.
CONCLUSIONS


In this small, single-center, nonblinded trial involving patients with chronic edema of the leg and cellulitis, compression therapy resulted in a lower incidence of recurrence of cellulitis than conservative treatment. (Funded by Calvary Public Hospital Bruce; Australian and New Zealand Clinical Trials Registry number, ACTRN12617000412336.).",2020,Most quality-of-life outcomes did not differ between the two groups.,"['Participants in the control group who had an episode of cellulitis crossed over to the compression group', 'A total of 183 patients were screened, and 84 were enrolled; 41 participants', 'participants with chronic edema of the leg and recurrent cellulitis, in a 1:1 ratio, to receive', 'patients with chronic edema of the leg and cellulitis']","['leg compression therapy plus education on cellulitis prevention (compression group) or education alone (control group', 'compression therapy', 'Compression Therapy', 'compression garments']","['cellulitis-related hospital admission and quality-of-life assessments', 'Most quality-of-life outcomes', 'adverse events', 'hospitalized for cellulitis', 'recurrence of cellulitis', 'episode of cellulitis']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0333241', 'cui_str': 'Chronic edema'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0742020', 'cui_str': 'Recurrent cellulitis'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2985539', 'cui_str': 'Compression garment'}]","[{'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",183.0,0.162501,Most quality-of-life outcomes did not differ between the two groups.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Webb', 'Affiliation': 'From the Physiotherapy Department, Calvary Public Hospital Bruce, Bruce, ACT (E.W.), the Biological Data Science Institute, the Australian National University Joint Colleges of Science, Health, and Medicine (T.N.), and the Medical School (F.J.B.), Australian National University, the University of Canberra Research Institute for Sport and Exercise (J.G.), and the Discipline of Physiotherapy, Faculty of Health, University of Canberra (E.W., B.B.), Canberra, ACT, and the Australian Institute of Health Innovation, Macquarie University, Sydney (V.M.) - all in Australia.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Neeman', 'Affiliation': 'From the Physiotherapy Department, Calvary Public Hospital Bruce, Bruce, ACT (E.W.), the Biological Data Science Institute, the Australian National University Joint Colleges of Science, Health, and Medicine (T.N.), and the Medical School (F.J.B.), Australian National University, the University of Canberra Research Institute for Sport and Exercise (J.G.), and the Discipline of Physiotherapy, Faculty of Health, University of Canberra (E.W., B.B.), Canberra, ACT, and the Australian Institute of Health Innovation, Macquarie University, Sydney (V.M.) - all in Australia.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Bowden', 'Affiliation': 'From the Physiotherapy Department, Calvary Public Hospital Bruce, Bruce, ACT (E.W.), the Biological Data Science Institute, the Australian National University Joint Colleges of Science, Health, and Medicine (T.N.), and the Medical School (F.J.B.), Australian National University, the University of Canberra Research Institute for Sport and Exercise (J.G.), and the Discipline of Physiotherapy, Faculty of Health, University of Canberra (E.W., B.B.), Canberra, ACT, and the Australian Institute of Health Innovation, Macquarie University, Sydney (V.M.) - all in Australia.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Gaida', 'Affiliation': 'From the Physiotherapy Department, Calvary Public Hospital Bruce, Bruce, ACT (E.W.), the Biological Data Science Institute, the Australian National University Joint Colleges of Science, Health, and Medicine (T.N.), and the Medical School (F.J.B.), Australian National University, the University of Canberra Research Institute for Sport and Exercise (J.G.), and the Discipline of Physiotherapy, Faculty of Health, University of Canberra (E.W., B.B.), Canberra, ACT, and the Australian Institute of Health Innovation, Macquarie University, Sydney (V.M.) - all in Australia.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Mumford', 'Affiliation': 'From the Physiotherapy Department, Calvary Public Hospital Bruce, Bruce, ACT (E.W.), the Biological Data Science Institute, the Australian National University Joint Colleges of Science, Health, and Medicine (T.N.), and the Medical School (F.J.B.), Australian National University, the University of Canberra Research Institute for Sport and Exercise (J.G.), and the Discipline of Physiotherapy, Faculty of Health, University of Canberra (E.W., B.B.), Canberra, ACT, and the Australian Institute of Health Innovation, Macquarie University, Sydney (V.M.) - all in Australia.'}, {'ForeName': 'Bernie', 'Initials': 'B', 'LastName': 'Bissett', 'Affiliation': 'From the Physiotherapy Department, Calvary Public Hospital Bruce, Bruce, ACT (E.W.), the Biological Data Science Institute, the Australian National University Joint Colleges of Science, Health, and Medicine (T.N.), and the Medical School (F.J.B.), Australian National University, the University of Canberra Research Institute for Sport and Exercise (J.G.), and the Discipline of Physiotherapy, Faculty of Health, University of Canberra (E.W., B.B.), Canberra, ACT, and the Australian Institute of Health Innovation, Macquarie University, Sydney (V.M.) - all in Australia.'}]",The New England journal of medicine,['10.1056/NEJMoa1917197']
2436,32786002,Benzodiazepine Use and Deprescribing in Belgian Nursing Homes: Results from the COME-ON Study.,"BACKGROUND/OBJECTIVES


To describe the use and deprescribing of benzodiazepine receptor agonists (BZRAs) among nursing home residents (NHRs), to evaluate appropriateness of use and to identify factors associated with BZRA use and deprescribing.
DESIGN


Posthoc analysis of the Collaborative Approach to Optimize Medication Use for Older People in Nursing Homes (COME-ON) study, a cluster controlled trial that evaluated the impact of a complex intervention on potentially inappropriate prescriptions (PIPs) in nursing homes (NHs).
SETTING


A total of 54 NHs in Belgium.
PARTICIPANTS


A total of 797 NHRs included in the study who had complete medical, clinical, and medication information at baseline and at the end of the study (month 15).
MEASUREMENTS


Data were recorded by participating healthcare professionals. Reasons why BZRA use was considered as PIPs were assessed using the 2019 American Geriatrics Society Beers Criteria® and the Screening Tool of Older Persons' Prescriptions (STOPP) criteria, version 2. Deprescribing included complete cessation or decreased daily dose. We identified factors at the NHR, prescriber, and NH levels associated with BZRA use and BZRA deprescribing using multivariable binary and multinomial logistic regression, respectively.
RESULTS


At baseline, 418 (52.4%) NHRs were taking a BZRA. The use of BZRA for longer than 4 weeks, with two or more other central nervous system active drugs, and in patients with delirium, cognitive impairment, falls, or fractures was found in more than 67% of BZRA users. Eight NHR-related variables and two prescriber-related variables were associated with regular BZRA use. Deprescribing occurred in 28.1% of BZRA users (32.9% in the intervention group and 22.1% in the control group). In addition to four other factors, dementia (odds ratio [OR] = 2.35; 95% confidence interval [CI] = [1.45-3.83]) and intervention group (OR = 1.74; 95% CI = 1.07-2.87) were associated with deprescribing.
CONCLUSION


Use of BZRAs was highly prevalent, and reasons to consider it as PIP were frequent. Deprescribing occurred in one-fourth of NHRs, which is encouraging. Future interventions should focus on specific aspects of PIPs (ie, indication, duration, drug-drug and drug-disease interactions) as well as on nondementia patients.",2020,"In addition to four other factors, dementia (odds ratio [OR] = 2.35; 95% confidence interval [CI] = [1.45-3.83]) and intervention group (OR = 1.74; 95% CI = 1.07-2.87) were associated with deprescribing.
","['nursing homes (NHs', 'A total of 54 NHs in Belgium', 'nursing home residents (NHRs', ""2019 American Geriatrics Society Beers Criteria® and the Screening Tool of Older Persons' Prescriptions (STOPP) criteria, version 2"", 'Older People in Nursing Homes', 'Belgian Nursing Homes', 'A total of 797 NHRs included in the study who had complete medical, clinical, and medication information at baseline and at the end of the study (month 15']","['benzodiazepine receptor agonists (BZRAs', 'complex intervention', 'Benzodiazepine', 'BZRA', 'BZRAs']",['Deprescribing'],"[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C4042847', 'cui_str': 'de Beers Criteria'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0337797', 'cui_str': 'Belgians'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0205923', 'cui_str': 'Benzodiazepine Receptors'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}]",[],,0.0500697,"In addition to four other factors, dementia (odds ratio [OR] = 2.35; 95% confidence interval [CI] = [1.45-3.83]) and intervention group (OR = 1.74; 95% CI = 1.07-2.87) were associated with deprescribing.
","[{'ForeName': 'Perrine', 'Initials': 'P', 'LastName': 'Evrard', 'Affiliation': 'Clinical Pharmacy Research Group, Université Catholique de Louvain, Louvain Drug Research Institute, Brussels, Belgium.'}, {'ForeName': 'Séverine', 'Initials': 'S', 'LastName': 'Henrard', 'Affiliation': 'Clinical Pharmacy Research Group, Université Catholique de Louvain, Louvain Drug Research Institute, Brussels, Belgium.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Foulon', 'Affiliation': 'Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Spinewine', 'Affiliation': 'Clinical Pharmacy Research Group, Université Catholique de Louvain, Louvain Drug Research Institute, Brussels, Belgium.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16751']
2437,32786068,Exercise-induced elevations in cerebral blood velocity are greater in running compared to cycling at higher intensities.,"The optimal exercise intensity and modality for maximizing cerebral blood flow (CBF) and hence potential exposure to positive, hemodynamically derived cerebral adaptations is yet to be fully determined. This study compared CBF velocity responses between running and cycling across a range of exercise intensities. Twenty-six participants (12 females; age: 26 ± 8 years) completed four exercise sessions; two mode-specific maximal oxygen consumption (VO 2max  ) tests, followed by (order randomized) two incremental exercise protocols (3-min stages at 35%, 50%, 65%, 80%, 95% VO 2max  ). Continuous measures of middle cerebral artery velocity (MCAv), oxygen consumption, end-tidal CO 2  (P ET  CO 2  ), and heart rate were obtained. Modality-specific MCAv changes were observed for the whole group (interaction effect: p = .01). Exercise-induced increases in MCAv mean  during cycling followed an inverted-U pattern, peaking at 65% VO 2max  (Δ12 ± 7 cm/s from rest), whereas MCAv mean  during running increased linearly up to 95% VO 2max  (change from rest: Δ12 ± 13 vs. Δ7 ± 8 cm/s for running vs. cycling at 95% VO 2max  ; p = .01). In contrast, both modalities had an inverted-U pattern for P ET  CO 2  changes, although peaked at different intensities (running: 50% VO 2max  , Δ6 ± 2 mmHg; cycling: 65% VO 2max  , Δ7 ± 2 mmHg; interaction effect: p = .01). Further subgroup analysis revealed that the running-specific linear MCAv mean  response was fitness dependent (Fitness*modality*intensity interaction effect: p = .04). Above 65% VO 2max  , fitter participants (n = 16; male > 45 mL/min/kg and female > 40 mL/min/kg) increased MCAv mean  up to 95% VO 2max  , whereas in unfit participants (n = 7, male < mL/min/kg and female < 35 mL/min/kg) MCAv mean  returned toward resting values. Findings demonstrate that modality- and fitness-specific profiles for MCAv mean  are seen at exercise intensities exceeding 65% VO 2max  .",2020,Modality-specific MCAv changes were observed for the whole group (interaction effect: p = .01).,"['\xa035', 'Twenty-six participants (12 females; age: 26\xa0±\xa08\xa0years) completed four']","['exercise sessions; two mode-specific maximal oxygen consumption (VO 2max  ) tests, followed by (order randomized) two incremental exercise protocols']","['MCAv mean  during running', 'cerebral blood velocity', 'middle cerebral artery velocity (MCAv), oxygen consumption, end-tidal CO 2  (P ET  CO 2  ), and heart rate', 'CBF velocity responses', 'MCAv mean', 'Modality-specific MCAv changes']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C1531610', 'cui_str': 'Blood velocity'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",26.0,0.153495,Modality-specific MCAv changes were observed for the whole group (interaction effect: p = .01).,"[{'ForeName': 'Rhodri J', 'Initials': 'RJ', 'LastName': 'Furlong', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Weaver', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Sutherland', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Claire V', 'Initials': 'CV', 'LastName': 'Burley', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Gabriella M', 'Initials': 'GM', 'LastName': 'Imi', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Rebekah A I', 'Initials': 'RAI', 'LastName': 'Lucas', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Samuel J E', 'Initials': 'SJE', 'LastName': 'Lucas', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Birmingham, UK.'}]",Physiological reports,['10.14814/phy2.14539']
2438,32786112,Is pelvic floor muscle training able to alter the response of cardiovascular autonomic modulation and provide a possible cardiovascular benefit to pregnant women?,"AIMS


To evaluate the acute and chronic effect of an exercise protocol of pelvic floor muscles (PFMs) contraction on the heart period (HP) and systolic arterial pressure (SAP) variabilities and baroreflex sensitivity (BRS) at rest in pregnant women; and to evaluate if this progressive exercise protocol was well-tolerated by the pregnant women studied.
METHODS


We evaluated 48 women at 18 weeks of pregnancy by vaginal palpation, vaginal manometry, and cardiopulmonary exercise test. They were divided in control (CG; 31.75 ± 3.91 years) and training groups (TG; 30.71 ± 3.94 years). At 19 and 36 weeks of pregnancy, electrocardiogram and noninvasive peripheral SAP data were collected at rest before and after 10 PFM contractions. TG performed PFMT from the 20th to the 36th week. HP and SAP variabilities were analyzed by spectral and symbolic analysis. The baroreflex was evaluated by cross-spectral analysis between the HP and SAP series.
RESULTS


The groups did not differ in relation to VO 2  , HP and SAP variabilities, and BRS at the beginning of the protocol. TG increased the endurance of the PFM after training. PFM contraction did not change the HP and SAP variabilities, and BRS at the 18th week. After the training, the TG presented lower SAP mean, lower BF of SAP variability, and higher BRS than CG.
CONCLUSIONS


Acute PFM contractions did not alter HP and SAP variabilities and BRS, but PFMT resulted in a lower SAP mean and higher BRS in trained pregnant when compared to the untrained.",2020,"After the training, the TG presented lower SAP mean, lower BF of SAP variability, and higher BRS than CG.
","['pregnant women studied', '48 women at 18\u2009weeks of pregnancy by vaginal palpation, vaginal manometry, and cardiopulmonary exercise test', 'pregnant women']","['progressive exercise protocol', 'exercise protocol of pelvic floor muscles (PFMs) contraction']","['HP and SAP variabilities, and BRS', 'pregnancy, electrocardiogram and noninvasive peripheral SAP data', 'relation to VO 2  , HP and SAP variabilities, and BRS', 'HP and SAP variabilities', 'heart period (HP) and systolic arterial pressure (SAP) variabilities and baroreflex sensitivity (BRS', 'HP and SAP variabilities and BRS', 'SAP mean and higher BRS', 'PFM contraction', 'SAP mean, lower BF of SAP variability']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0024751', 'cui_str': 'Manometry'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1868598', 'cui_str': 'Enlarged parietal foramina'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",48.0,0.0360243,"After the training, the TG presented lower SAP mean, lower BF of SAP variability, and higher BRS than CG.
","[{'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'da Silva Corrêa', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Rodovia Washington Luís, km 235, Monjolinho, São Carlos, São Paulo, Brazil.""}, {'ForeName': 'Aparecida M', 'Initials': 'AM', 'LastName': 'Catai', 'Affiliation': 'Cardiovascular Physiotherapy Laboratory, Physical Therapy Department, Rodovia Washington Luís, km 235, Monjolinho, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Juliana C', 'Initials': 'JC', 'LastName': 'Milan-Mattos', 'Affiliation': 'Cardiovascular Physiotherapy Laboratory, Physical Therapy Department, Rodovia Washington Luís, km 235, Monjolinho, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Porta', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Milan, Italy.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Driusso', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Rodovia Washington Luís, km 235, Monjolinho, São Carlos, São Paulo, Brazil.""}]",Neurourology and urodynamics,['10.1002/nau.24481']
2439,32787371,The application of thromboelastography in risk stratification for selective thromboembolism prophylaxis after total joint arthroplasty in Chinese: a randomized controlled trial.,"BACKGROUND


As Asian populations, Chinese have a lower rate of high-risk gene mutations in venous thrombosis. Therefore, individual patient risk assessment, rather than a ""blanket policy"", is considered the best thromboembolism prophylaxis for Chinese. The purpose of this study was to evaluate the effectiveness and safety of selective thromboembolism prophylaxis compared with conventional thromboembolism prophylaxis by risk stratification with thromboelastography (TEG) after joint arthroplasty in Chinese.
METHODS


Between August 2016 to August 2017, Chinese patients who underwent hip or knee arthroplasty were randomly divided into a selective anticoagulation group (SAG) and a conventional anticoagulation group (CAG). Participants and outcome assessors were blinded. In the SAG, an anticoagulant was used when TEG indicated hypercoagulability; while in the CAG, an anticoagulant was regularly used until one month after surgery. Outcome evaluation included effectiveness (defined as the incidence of VTE), and safety (defined as the incidence of bleeding events, poor wound healing, blood loss, and infection).
RESULTS


A total of 197 patients (79 in the SAG and 118 in the CAG) were included in the study. There was 1 case of deep vein thrombosis (DVT) in the SAG and 2 cases of DVT in the CAG, but there was no significant difference between the two groups. Hidden blood loss in the SAG was 707.4±539.8 mL and hidden blood loss in the CAG was 617±565.0 mL, respectively (P>0.05). No significant difference was observed in perioperative blood loss between the SAG and the CAG (1,024.9±597.9 and 1,139.3±620.9 mL, respectively). Volume of blood transfusion was 92.4±270.2 mL in the SAG and 224.6±416.3 mL in the CAG, respectively, while rate of transfusion was 13.9% in the SAG and 33.9% in the CAG, respectively, which were significantly different between the two groups (P<0.05).
CONCLUSIONS


In Chinese patients who underwent hip or knee arthroplasty, the efficacy of selective anticoagulation using TEG in risk stratification was comparable to that of conventional anticoagulation. Furthermore, the safety of selective anticoagulant prophylaxis was superior to that of conventional anticoagulant prophylaxis.",2020,"In Chinese patients who underwent hip or knee arthroplasty, the efficacy of selective anticoagulation using TEG in risk stratification was comparable to that of conventional anticoagulation.","['197 patients (79 in the SAG and 118 in the CAG) were included in the study', 'selective thromboembolism prophylaxis after total joint arthroplasty in Chinese', 'Between August 2016 to August 2017, Chinese patients who underwent hip or knee arthroplasty', 'Chinese patients who underwent hip or knee arthroplasty', 'joint arthroplasty in Chinese']","['thromboelastography (TEG', 'selective thromboembolism prophylaxis', 'conventional thromboembolism prophylaxis', 'selective anticoagulation group (SAG) and a conventional anticoagulation group (CAG', 'thromboelastography']","['deep vein thrombosis (DVT', 'Hidden blood loss', 'effectiveness and safety', 'rate of transfusion', 'Volume of blood transfusion', 'hypercoagulability', 'perioperative blood loss', 'effectiveness (defined as the incidence of VTE), and safety (defined as the incidence of bleeding events, poor wound healing, blood loss, and infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199242', 'cui_str': 'Anticoagulant prophylaxis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C0199242', 'cui_str': 'Anticoagulant prophylaxis'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0205262', 'cui_str': 'Occult'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0398623', 'cui_str': 'Thrombophilia'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",197.0,0.0498045,"In Chinese patients who underwent hip or knee arthroplasty, the efficacy of selective anticoagulation using TEG in risk stratification was comparable to that of conventional anticoagulation.","[{'ForeName': 'Ziming', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopedics, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China; Centre for Orthopaedic Translational Research, Medical School, University of Western Australia, Nedlands, Australia.""}, {'ForeName': 'Yuanchen', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""Department of Orthopedics, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Qingtian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Department of Orthopedics, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Zhantao', 'Initials': 'Z', 'LastName': 'Deng', 'Affiliation': ""Department of Orthopedics, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China. dengzhantao_med@163.com.""}, {'ForeName': 'Qiujian', 'Initials': 'Q', 'LastName': 'Zheng', 'Affiliation': ""Department of Orthopedics, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China. ZQJzqj666@yeah.net.""}]",Annals of palliative medicine,['10.21037/apm-19-385']
2440,32787506,A Pilot Study of An Intervention to Increase Family Member Involvement in Nursing Home Care Plan Meetings.,"BACKGROUND AND OBJECTIVES


Many family members struggle to negotiate their aging relative's care with nursing home staff, potentially leading to depression and other negative outcomes for residents' families. This pilot study tested an intervention designed to empower residents' family members to attend and participate in nursing home care plan meetings.
RESEARCH DESIGN AND METHODS


We conducted a small, randomized, controlled trial of the Families Involved in Nursing home Decision-making (FIND) intervention, which used web conferencing to facilitate family participation in care plan meetings.
RESULTS


Overall, FIND was feasible and acceptable. Family members who received the FIND intervention were more likely to experience decreased depressive symptoms than those who did not.
DISCUSSION AND IMPLICATIONS


FIND is a promising approach to reduce depression among family members of nursing home residents. Findings support the need for a follow-up clinical trial.",2020,"Family members who received the FIND intervention were more likely to experience decreased depressive symptoms than those who did not.
","['family members of nursing home residents', ""empower residents' family members to attend and participate in nursing home care plan meetings""]",[],['depressive symptoms'],"[{'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0178916', 'cui_str': 'Care plan'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0402854,"Family members who received the FIND intervention were more likely to experience decreased depressive symptoms than those who did not.
","[{'ForeName': 'Debra Parker', 'Initials': 'DP', 'LastName': 'Oliver', 'Affiliation': 'University of Missouri, Columbia, USA.'}, {'ForeName': 'Abigail J', 'Initials': 'AJ', 'LastName': 'Rolbiecki', 'Affiliation': 'University of Missouri, Columbia, USA.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Washington', 'Affiliation': 'University of Missouri, Columbia, USA.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Kruse', 'Affiliation': 'University of Missouri, Columbia, USA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Popejoy', 'Affiliation': 'University of Missouri, Columbia, USA.'}, {'ForeName': 'Jamie B', 'Initials': 'JB', 'LastName': 'Smith', 'Affiliation': 'University of Missouri, Columbia, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Demiris', 'Affiliation': 'The University of Pennsylvania School of Nursing, Philadelphia, USA.'}]",Journal of applied gerontology : the official journal of the Southern Gerontological Society,['10.1177/0733464820946927']
2441,32787541,Recruitment best practices of a cardiovascular risk reduction randomised control trial in rural Alaska Native communities.,"Though not native to Alaska, tobacco use is common among Alaska Native people in the Norton Sound region, an area consisting of 16 communities with population size 107 to 3,695. We summarise best practices in recruiting Alaska Native adults who smoke for a randomised controlled tobacco treatment trial. Participants were Alaska Native, 19 years and older, smoking daily, with hypertension and/or high cholesterol, residing in the Norton Sound region of Alaska. Study staff travelled to the remote communities to recruit, typically staying 5 days. Screening and enrolment success was examined by day, season, and staffing level. From June 2015 - December 2018, the study team made 122 trips, screening 1089 individuals and enrolling 314 participants. In the field, days 2-3 (51%) were best for screening, while days 3-4 (53%) had the greatest enrolment. Community size correlated with enrolment (r = 0.83, p <.001). Recruitment was optimised in spring and with multiple staff in the field. Despite challenges (e.g., harsh weather, poor internet connectivity), with active outreach (e.g. tabling in busy areas, attending community events, utilising mixed media, collaborating with clinic staff), the project reached its recruitment goal. Study findings can inform community-based tobacco treatment research trials in remote areas.
ABBREVIATIONS


CVD: Cardiovascular disease; VTC: Video teleconferencing; ANMC: Alaska Native Medical Centre; HEALTHH: Healing and Empowering Alaskan Lives Towards Healthy Hearts; NSHC: Norton Sound Health Corporation; RERB: Research Ethics Review Board.",2020,"Community size correlated with enrolment (r = 0.83, p <.001).","['Participants were Alaska Native, 19\xa0years and older, smoking daily, with hypertension and/or high cholesterol, residing in the Norton Sound region of Alaska', 'Towards Healthy Hearts', 'rural Alaska Native communities', 'Alaska Native people in the Norton Sound region, an area consisting of 16 communities with population size 107 to 3,695', 'From June 2015 - December 2018, the study team made 122 trips, screening 1089 individuals and enrolling 314 participants', 'CVD']",[' NSHC'],[],"[{'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0001905', 'cui_str': 'Alaska'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0032683', 'cui_str': 'Population Size'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0077275', 'cui_str': 'Triptorelin'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C1312067', 'cui_str': 'SHC3 protein, human'}]",[],314.0,0.0838417,"Community size correlated with enrolment (r = 0.83, p <.001).","[{'ForeName': 'Mariah', 'Initials': 'M', 'LastName': 'Knox', 'Affiliation': 'Cardiology Department, Alaska Native Tribal Health Consortium , Anchorage, AK, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Skan', 'Affiliation': 'Cardiology Department, Alaska Native Tribal Health Consortium , Anchorage, AK, USA.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Department of Medicine, Division of Cardiology, University of California , San Francisco, CA, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Schnellbaecher', 'Affiliation': 'Cardiology Department, Alaska Native Tribal Health Consortium , Anchorage, AK, USA.'}, {'ForeName': 'Judith J', 'Initials': 'JJ', 'LastName': 'Prochaska', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University.'}]",International journal of circumpolar health,['10.1080/22423982.2020.1806639']
2442,32787595,The efficacy of transversus abdominis plane block for postoperative analgesia in laparoscopic cholecystectomy cases: a retrospective evaluation of 515 patients.,"OBJECTIVE


To compare patients that received intravenous (i.v.) analgesics with those that received transversus abdominis plane (TAP) block for pain relief after laparoscopic cholecystectomy.
METHODS


This retrospective study enrolled patients that had undergone laparoscopic cholecystectomy and divided them into two groups: the i.v. analgesic group (controls; group A) and the TAP block group (group T). Data retrieved from the medical records included postoperative visual analogue scale (VAS) pain scores, duration of intensive care unit (ICU) stay, total hospital stay, additional analgesic requirements and the occurrence of nausea and vomiting.
RESULTS


A total of 515 patients were included (group A,  n  = 247; group T,  n  = 268). Postoperative VAS pain scores at 0, 2, 4 and 6 h and the need for additional analgesics were significantly lower in group T than in group A. Postoperative VAS pain scores at 12 and 24 h were significantly higher in group T than in group A. Postoperative nausea and vomiting were significantly lower in group T than in group A. The rate of ICU admission in group T was significantly lower than in group A.
CONCLUSIONS


Effective postoperative analgesia can be achieved with TAP block and undesirable effects can be reduced.",2020,"Postoperative VAS pain scores at 0, 2, 4 and 6 h and the need for additional analgesics were significantly lower in group T than in group A. Postoperative VAS pain scores at 12 and 24 h were significantly higher in group T than in group A. Postoperative nausea and vomiting were significantly lower in group T than in group A.","['515 patients were included (group A,  n \u2009=\u2009247; group T,  n \u2009=\u2009268', 'enrolled patients that had undergone', 'laparoscopic cholecystectomy cases', '515 patients']","['transversus abdominis plane', 'transversus abdominis plane block', 'TAP) block', 'intravenous (i.v', 'laparoscopic cholecystectomy', 'TAP block']","['need for additional analgesics', 'rate of ICU admission', 'pain relief', 'Postoperative nausea and vomiting', 'Postoperative VAS pain scores', 'postoperative visual analogue scale (VAS) pain scores, duration of intensive care unit (ICU) stay, total hospital stay, additional analgesic requirements and the occurrence of nausea and vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0036669', 'cui_str': 'Group T'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}]",515.0,0.0238099,"Postoperative VAS pain scores at 0, 2, 4 and 6 h and the need for additional analgesics were significantly lower in group T than in group A. Postoperative VAS pain scores at 12 and 24 h were significantly higher in group T than in group A. Postoperative nausea and vomiting were significantly lower in group T than in group A.","[{'ForeName': 'Arzu Esen', 'Initials': 'AE', 'LastName': 'Tekeli', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Van Yuzuncu Yil University School of Medicine, Van, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Eker', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, İstanbul, Turkey.'}, {'ForeName': 'Mehmet Kadir', 'Initials': 'MK', 'LastName': 'Bartin', 'Affiliation': 'Department of General Surgery, Health Sciences University Van Training and Research Hospital, Van, Turkey.'}, {'ForeName': 'Muzaffer Önder', 'Initials': 'MÖ', 'LastName': 'Öner', 'Affiliation': 'Department of General Surgery, Health Sciences University Van Training and Research Hospital, Van, Turkey.'}]",The Journal of international medical research,['10.1177/0300060520944058']
2443,32787848,"Effects of vaginal administration of conjugated estrogens tablet on sexual function in postmenopausal women with sexual dysfunction: a double-blind, randomized, placebo-controlled trial.","BACKGROUND


Female sexual dysfunction (FSD) is prevalent in women with genitourinary syndrome of menopause (GSM). Vaginal estrogen is effective GSM treatment. This study was primarily aimed to evaluate the effects of vaginal administration of conjugated estrogens tablet on postmenopausal FSD using the Female Sexual Function Index (FSFI). Secondary aims were to evaluate vaginal pH, Vaginal Maturation Value (VMV), Normal Flora Index (NFI) and Most Bothersome Symptoms (MBS) changes.
METHODS


A double-blind trial was conducted in postmenopausal women with FSD (FSFI ≤26.55). Sixty-seven participants were randomized into two arms; vaginally administered conjugated estrogens tablet (0.625 mg, daily for 3 weeks then twice weekly for 9 weeks, n = 33), or placebo (n = 34).
RESULTS


There was no significant improvement of FSFI observed in estrogens arm compared to placebo in each domain and overall index (p = 0.182). The estrogens significantly improved vaginal pH and VMV, toward more acidity (p = < 0.001), higher VMV (p = < 0.001) and more superficial cells (p = < 0.001). We observed no significant difference in NFI and MBS between arms (p = 0.282, 0.182).
CONCLUSION


We found no significant changes in FSFI, NFI, and MBS, but significant improvement in vaginal pH and VMV in postmenopausal women with FSD treated with vaginally administered conjugated estrogens tablet. Few side-effects were reported.
TRIAL REGISTRATION


Thai Clinical Trial Registry identification number TCTR20180219001 , prospectively registered since 2018-02-19 11:33:21.",2020,"The estrogens significantly improved vaginal pH and VMV, toward more acidity (p = < 0.001), higher VMV (p = < 0.001) and more superficial cells (p = < 0.001).","['women with genitourinary syndrome of menopause (GSM', 'Sixty-seven participants', 'postmenopausal women with FSD (FSFI ≤26.55', 'postmenopausal women with FSD treated with vaginally administered', 'postmenopausal women with sexual dysfunction', 'postmenopausal FSD using the Female Sexual Function Index (FSFI']","['vaginal administration of conjugated estrogens tablet', 'vaginally administered conjugated estrogens tablet', 'conjugated estrogens tablet', 'placebo']","['FSFI, NFI, and MBS', 'superficial cells', 'FSFI', 'vaginal pH and VMV', 'sexual function', 'vaginal pH, Vaginal Maturation Value (VMV), Normal Flora Index (NFI) and Most Bothersome Symptoms (MBS) changes', 'vaginal pH and VMV, toward more acidity', 'NFI and MBS', 'higher VMV']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C5192371', 'cui_str': 'Genitourinary syndrome of menopause'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C1112442', 'cui_str': 'Female sexual dysfunction'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}]","[{'cui': 'C0001561', 'cui_str': 'Medication administration: vaginal'}, {'cui': 'C0014938', 'cui_str': 'Estrogens, Conjugated (USP)'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0314761', 'cui_str': 'Normal flora'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0205250', 'cui_str': 'High'}]",67.0,0.625373,"The estrogens significantly improved vaginal pH and VMV, toward more acidity (p = < 0.001), higher VMV (p = < 0.001) and more superficial cells (p = < 0.001).","[{'ForeName': 'Thanapob', 'Initials': 'T', 'LastName': 'Bumphenkiatikul', 'Affiliation': 'Division of Reproductive Medicine, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, 1873 Rama IV Road, Bangkok, 10330, Thailand. thanapob@chula.md.'}, {'ForeName': 'Krasean', 'Initials': 'K', 'LastName': 'Panyakhamlerd', 'Affiliation': 'Division of Reproductive Medicine, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, 1873 Rama IV Road, Bangkok, 10330, Thailand.'}, {'ForeName': 'Thanittha', 'Initials': 'T', 'LastName': 'Chatsuwan', 'Affiliation': 'Department of Microbiology, Faculty of Medicine, Chulalongkorn University, Bangkok, 10330, Thailand.'}, {'ForeName': 'Chai', 'Initials': 'C', 'LastName': 'Ariyasriwatana', 'Affiliation': 'Division of Gynecologic Cyto-Pathology, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Bangkok, 10330, Thailand.'}, {'ForeName': 'Ammarin', 'Initials': 'A', 'LastName': 'Suwan', 'Affiliation': 'Division of Reproductive Medicine, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, 1873 Rama IV Road, Bangkok, 10330, Thailand.'}, {'ForeName': 'Charoen', 'Initials': 'C', 'LastName': 'Taweepolcharoen', 'Affiliation': 'Division of Reproductive Medicine, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, 1873 Rama IV Road, Bangkok, 10330, Thailand.'}, {'ForeName': 'Nimit', 'Initials': 'N', 'LastName': 'Taechakraichana', 'Affiliation': 'Department of Medical Education and Clinical Research Center, Bumrungrad International Hospital, Bangkok, 10110, Thailand.'}]",BMC women's health,['10.1186/s12905-020-01031-4']
2444,31115908,"Model-Based Population Pharmacokinetic Analysis of Nivolumab in Chinese Patients With Previously Treated Advanced Solid Tumors, Including Non-Small Cell Lung Cancer.","Nivolumab is the first anti-programmed death-1 agent approved in China for treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC). Here, we characterize the population pharmacokinetics (PPK) of nivolumab monotherapy in Chinese patients with previously treated advanced/recurrent solid tumors, including NSCLC and nasopharyngeal cancer (NPC), using data from 2 predominantly Chinese (CheckMate 077 and 078), and 5 global (MDX1106-01, CA209-003, and CheckMate 017, 057, and 063) studies. The PPK model was developed by reestimating parameters of a prior global population model with Chinese patient data. Model reestimates showed nivolumab pharmacokinetics (PK) to be linear and dose proportional. Race did not have a clinically meaningful effect on nivolumab clearance. Body weight, Asian race, sex, and performance status had significant effects on clearance. Baseline clearance was 9% lower in the Asian versus the global population but not considered clinically relevant. Change in time-varying clearance and predicted nivolumab exposures with 3 mg/kg every 2 weeks (Q2W) were similar in Chinese, non-Chinese Asian, and non-Asian patients. In Chinese patients, the predicted nivolumab exposure with a 240-mg Q2W regimen was ∼25% higher than with 3 mg/kg Q2W, but ∼62% lower than that of a previously evaluated, well-tolerated regimen of 10 mg/kg Q2W (global population). Differences in nivolumab baseline clearance and exposures between patients with NPC and NSCLC were not clinically meaningful (<20%). Overall, PPK analysis demonstrated that nivolumab was not sensitive to race when evaluated in Chinese and non-Asian patients and exhibited similar PK in NSCLC and NPC.",2019,Differences in nivolumab baseline clearance and exposures between patients with NPC and NSCLC were not clinically meaningful (<20%).,"['Chinese Patients With Previously Treated Advanced Solid Tumors, Including Non-Small Cell Lung Cancer', 'Chinese patients with previously treated advanced/recurrent solid tumors, including NSCLC and nasopharyngeal cancer (NPC), using data from 2 predominantly Chinese (CheckMate 077 and 078), and 5 global (MDX1106-01, CA209-003, and CheckMate 017, 057, and 063) studies', 'locally advanced or metastatic non-small cell lung cancer (NSCLC']",['nivolumab monotherapy'],"['nivolumab clearance', 'clearance', 'Baseline clearance', 'nivolumab pharmacokinetics (PK']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0153392', 'cui_str': 'Malignant tumor of nasopharynx'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C2346820', 'cui_str': 'MDX-1106'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.130334,Differences in nivolumab baseline clearance and exposures between patients with NPC and NSCLC were not clinically meaningful (<20%).,"[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Junliang', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'Bristol-Myers Squibb, Shanghai, China.'}, {'ForeName': 'Akintunde', 'Initials': 'A', 'LastName': 'Bello', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sheng', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1432']
2445,31809866,The Vitamin D Assessment (ViDA) study - Design and main findings.,"Accumulating evidence from observational studies indicates that vitamin D status is inversely associated with a many non-skeletal diseases. This has initiated the conduct of several large clinical trials to determine if high dose vitamin D supplementation (≥ 2000 IU/day or monthly equivalent) prevents non-skeletal disease including cardiovascular disease, cancer and mortality. One of these trials is the Vitamin D Assessment (ViDA) Study which recruited 5110 participants, aged 50-84 years, mostly from primary care practices in Auckland, New Zealand. The intervention was a capsule that contained either 100,000 IU vitamin D3 or placebo, two of which were taken by each participant soon after randomization, and then monthly up to 31 July 2015 (median follow-up 3.3 years). Information on study outcomes came from self-completed questionnaires and health data collected routinely by the Ministry of Health. There was no effect of vitamin D on the main outcomes: cardiovascular disease, acute respiratory infections, non-vertebral fractures, falls and all cancer. In contrast, vitamin D increased persistence with taking statins among participants on long term statin therapy. Beneficial effects were seen also for lung function among ever smokers (especially if vitamin D deficient), and in participants with low 25-hydroxyvitamin D levels for bone mineral density and arterial function. The findings support future research being carried out mainly in people who are vitamin D deficient, although there are practical and ethical issues in recruiting such people into future vitamin D supplementation trials.",2020,"There was no effect of vitamin D on the main outcomes: cardiovascular disease, acute respiratory infections, non-vertebral fractures, falls and all cancer.","['5110 participants, aged 50-84 years, mostly from primary care practices in Auckland, New Zealand', 'participants on long term statin therapy']","['vitamin D', 'vitamin D supplementation', 'vitamin D3 or placebo']","['cardiovascular disease, cancer and mortality', 'lung function', 'main outcomes: cardiovascular disease, acute respiratory infections, non-vertebral fractures, falls and all cancer']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0238990', 'cui_str': 'Acute lower respiratory tract infection'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",,0.139111,"There was no effect of vitamin D on the main outcomes: cardiovascular disease, acute respiratory infections, non-vertebral fractures, falls and all cancer.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Scragg', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand. Electronic address: r.scragg@auckland.ac.nz.'}]",The Journal of steroid biochemistry and molecular biology,['10.1016/j.jsbmb.2019.105562']
2446,31811542,Development and evaluation of myofunctional therapy support program (MTSP) based on self-efficacy theory for patients with obstructive sleep apnea.,"PURPOSE


The aim of this study is to determine the impact of myofunctional therapy support program (MTSP) based on self-efficacy theory compared to no support during myofunctional therapy (MT) in patients with obstructive sleep apnea (OSA).
METHODS


Thirty-one patients with OSA were randomized into two groups: 12 weeks of treatment with the MTSP developed in this study (experimental group) and one education session of MT (control group). Patients were evaluated at the beginning and the end of the study using questionnaires (self-efficacy scale, Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, snoring intensity and frequency, dry mouth) and polysomnography.
RESULTS


The control (n = 15) and experimental (n = 16) groups had similar results for all variables at study entry. The control group showed no significant change in any variables during the study period. In contrast, the experimental group showed a significant increase in self-efficacy 61.38 ± 9.50 to 65.56 ± 10.89 (p = 0.020) and a significant decrease in apnea-hypopnea index (AHI) 19.51 ± 11.41 to 14.11 ± 9.13 (p = 0.039), daytime sleepiness 9.88 ± 3.84 to 7.56 ± 3.42 (p = 0.028), snoring intensity 5.57 ± 3.13 to 4.44 ± 2.68 (p = 0.008), and dry mouth 6.44 ± 3.14 to 3.63 ± 2.33 (p = 0.005), compared to the baseline. No significant change in lowest SaO2 (p = 0.969), sleep quality (p = 0.307), and snoring frequency (p = 0.321) during the study period.
CONCLUSIONS


The intensive and interactive intervention of MTSP improved the self-efficacy of OSA patients, and consequently, resulted in sign and symptom relief, such as AHI, daytime sleepiness, snoring and dry mouth. The MTSP was dedicated to the nurse practitioner to improve the way to dispense the MT. This research has implications for the successful treatment of OSA.",2020,"No significant change in lowest SaO2 (p = 0.969), sleep quality (p = 0.307), and snoring frequency (p = 0.321) during the study period.
","['Thirty-one patients with OSA', 'patients with obstructive sleep apnea', 'patients with obstructive sleep apnea (OSA']","['myofunctional therapy support program\xa0(MTSP', 'myofunctional therapy (MT', 'myofunctional therapy support program (MTSP', 'MTSP']","['daytime sleepiness', 'sign and symptom relief, such as AHI, daytime sleepiness, snoring and dry mouth', 'lowest SaO2', 'self-efficacy', 'questionnaires (self-efficacy scale, Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, snoring intensity and frequency, dry mouth) and polysomnography', 'sleep quality', 'snoring frequency', 'apnea-hypopnea index']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]","[{'cui': 'C0600516', 'cui_str': 'Oral Myotherapy'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0037384', 'cui_str': 'Snoring'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",31.0,0.0135267,"No significant change in lowest SaO2 (p = 0.969), sleep quality (p = 0.307), and snoring frequency (p = 0.321) during the study period.
","[{'ForeName': 'Jui', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Strategy and Planning, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Eui Geum', 'Initials': 'EG', 'LastName': 'Oh', 'Affiliation': 'College of Nursing, Yonsei University, 03722, Seoul, Republic of Korea.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Choi', 'Affiliation': 'College of Nursing, Yonsei University, 03722, Seoul, Republic of Korea.'}, {'ForeName': 'Su Jung', 'Initials': 'SJ', 'LastName': 'Choi', 'Affiliation': 'Department of Nursing, Department of Clinical Nursing Science, Graduate School of Clinical Nursing Science, Samsung Medical Center, Sungkyunkwan University, Seoul, Republic of Korea.'}, {'ForeName': 'Eun Yeon', 'Initials': 'EY', 'LastName': 'Joo', 'Affiliation': 'Department of Neurology, Neuroscience Center, Samsung Biomedical Research Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyangkyu', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Yonsei University, 03722, Seoul, Republic of Korea. hkyulee@yuhs.ac.'}, {'ForeName': 'Hyo Yeol', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Department of Otorhinolaryngology - Head and Neck Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center, 06351, Seoul, Republic of Korea. siamkhy@gmail.com.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-019-01957-6']
2447,31820334,Effect of Smartphone-Based Telemonitored Exercise Rehabilitation among Patients with Coronary Heart Disease.,"The aim of this study was to investigate the effects of telemonitored exercise rehabilitation on patients with coronary heart disease (CHD) in China. Ninety-six patients with stable CHD were included and analyzed (48 in telemonitored group and 48 in control group). All patients received routine follow-up, and patients in telemonitored group participated in smartphone-based telemonitored cardiac rehabilitation. Patients' demographic information, medical history, diagnosis and treatment of CHD, and laboratory results were collected. The difference of cardiopulmonary exercise testing (CPET), blood test, and echocardiographic parameters; exercise habits; control rate of blood lipid and blood glucose; and incidence of adverse events between the two groups during 6 months of follow-up was analyzed. After intervention, the subjects in the telemonitored group performed significantly better in VO 2peak , exercise compliance, and some other parameters than those in the control group. Telemonitored exercise rehabilitation is an effective rehabilitation mode for CHD patients in China.",2020,"After intervention, the subjects in the telemonitored group performed significantly better in VO 2peak , exercise compliance, and some other parameters than those in the control group.","['CHD patients in China', 'patients with coronary heart disease (CHD) in China', 'Ninety-six patients with stable CHD', 'Patients with Coronary Heart Disease']","['Smartphone-Based Telemonitored Exercise Rehabilitation', 'smartphone-based telemonitored cardiac rehabilitation', 'Telemonitored exercise rehabilitation', 'telemonitored exercise rehabilitation']","['cardiopulmonary exercise testing (CPET), blood test, and echocardiographic parameters; exercise habits; control rate of blood lipid and blood glucose; and incidence of adverse events', 'VO 2peak , exercise compliance']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",96.0,0.0186907,"After intervention, the subjects in the telemonitored group performed significantly better in VO 2peak , exercise compliance, and some other parameters than those in the control group.","[{'ForeName': 'Yanxin', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Cardiology and Institute of Vascular Medicine, Peking University Third Hospital, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Beijing, 100191, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Ren', 'Affiliation': 'Department of Cardiology and Institute of Vascular Medicine, Peking University Third Hospital, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Beijing, 100191, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology and Institute of Vascular Medicine, Peking University Third Hospital, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Beijing, 100191, China.'}, {'ForeName': 'Liyuan', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': 'Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, 100191, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology and Institute of Vascular Medicine, Peking University Third Hospital, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Beijing, 100191, China. beate_vv@bjmu.edu.cn.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology and Institute of Vascular Medicine, Peking University Third Hospital, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Beijing, 100191, China.'}]",Journal of cardiovascular translational research,['10.1007/s12265-019-09938-6']
2448,31834166,Outcome Evaluation of Highly Challenging Balance Training for People With Parkinson Disease: A Multicenter Effectiveness-Implementation Study.,"BACKGROUND AND PURPOSE


In order for people with Parkinson disease (PwPD) to benefit from neurorehabilitation research, interventions tested in research settings require assessment in real-world clinical practice. There is little evidence for whether efficacious exercise interventions for PwPD remain effective when transferred to standard clinical settings. The aim of this study was to assess the clinical effectiveness of the adapted HiBalance program on balance control and gait among PwPD.
METHODS


Participants (n = 117) with mild-moderate Parkinson disease were consecutively included into either the 10-week HiBalance group training (n = 61) or the control (n = 56) group. The main outcome was balance performance (Mini-BESTest). Secondary outcomes were comfortable gait speed (10-m Walk Test); functional mobility (Timed Up and Go [TUG] test) and dual-task interference (cognitive TUG test); physical activity level (steps per day); perceived balance confidence (Activities-specific Balance Confidence scale) and perceived walking difficulty (Walk-12G) and self-rated health (EQ-5D visual analog scale).
RESULTS


In total, 98 people completed the trial. Compared with controls, the training group showed significant improvement in balance performance (P < 0.001), gait speed (P = 0.001), and dual-task interference (P = 0.04) following the intervention. No group differences were observed for physical activity level or any patient-reported measures.
DISCUSSION AND CONCLUSIONS


Highly challenging balance training is effective at improving balance, gait, and dual-task performance when delivered at a clinically feasible dose, in a range of rehabilitation settings, without direct involvement of the research group.Video Abstract available for more insights from the authors (see the Video, Supplementary Digital Content 1, available at: http://links.lww.com/JNPT/A299).",2020,"Compared with controls, the training group showed significant improvement in balance performance (P < 0.001), gait speed (P = 0.001), and dual-task interference (P = 0.04) following the intervention.","['people with Parkinson disease (PwPD', 'Participants (n = 117) with mild-moderate Parkinson disease', '98 people completed the trial', 'People With Parkinson Disease']","['Highly Challenging Balance Training', 'adapted HiBalance program', 'HiBalance group training']","['balance performance (Mini-BESTest', 'balance performance', 'dual-task interference', 'gait speed', 'comfortable gait speed (10-m Walk Test); functional mobility (Timed Up and Go [TUG] test) and dual-task interference (cognitive TUG test); physical activity level (steps per day); perceived balance confidence (Activities-specific Balance Confidence scale) and perceived walking difficulty (Walk-12G) and self-rated health (EQ-5D visual analog scale', 'physical activity level']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C2733457', 'cui_str': 'Activities specific balance confidence scale'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1318183', 'cui_str': '12G'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",117.0,0.0896723,"Compared with controls, the training group showed significant improvement in balance performance (P < 0.001), gait speed (P = 0.001), and dual-task interference (P = 0.04) following the intervention.","[{'ForeName': 'Breiffni', 'Initials': 'B', 'LastName': 'Leavy', 'Affiliation': 'Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Huddinge, Sweden (B.L., C.J., N.L., H.J., M.H., E.F.); Stockholms Sjukhem Foundation, Stockholm, Sweden (B.L., E.F.); Department of Physiotherapy, University of the Western Cape, South Africa (C.J.); Function Area Occupational Therapy and Physiotherapy, Allied Health Professionals Function, Karolinska University Hospital, Stockholm, Sweden (N.L., M.H., E.F.); and Department of Health Promoting Science, Sophiahemmet University, Stockholm, Sweden (M.H.).'}, {'ForeName': 'Conran', 'Initials': 'C', 'LastName': 'Joseph', 'Affiliation': ''}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Löfgren', 'Affiliation': ''}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Johansson', 'Affiliation': ''}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hagströmer', 'Affiliation': ''}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Franzén', 'Affiliation': ''}]",Journal of neurologic physical therapy : JNPT,['10.1097/NPT.0000000000000298']
2449,31834217,"Upper Limb Robotic Rehabilitation After Stroke: A Multicenter, Randomized Clinical Trial.","BACKGROUND AND PURPOSE


After stroke, only 12% of survivors obtain complete upper limb (UL) functional recovery, while in 30% to 60% UL deficits persist. Despite the complexity of the UL, prior robot-mediated therapy research has used only one robot in comparisons to conventional therapy. We evaluated the efficacy of robotic UL treatment using a set of 4 devices, compared with conventional therapy.
METHODS


In a multicenter, randomized controlled trial, 247 subjects with subacute stroke were assigned either to robotic (using a set of 4 devices) or to conventional treatment, each consisting of 30 sessions. Subjects were evaluated before and after treatment, with follow-up assessment after 3 months. The primary outcome measure was change from baseline in the Fugl-Meyer Assessment (FMA) score. Secondary outcome measures were selected to assess motor function, activities, and participation.
RESULTS


One hundred ninety subjects completed the posttreatment assessment, with a subset (n = 122) returning for follow-up evaluation. Mean FMA score improvement in the robotic group was 8.50 (confidence interval: 6.82 to 10.17), versus 8.57 (confidence interval: 6.97 to 10.18) in the conventional group, with no significant between-groups difference (adjusted mean difference -0.08, P = 0.948). Both groups also had similar change in secondary measures, except for the Motricity Index, with better results for the robotic group (adjusted mean difference 4.42, P = 0.037). At follow-up, subjects continued to improve with no between-groups differences.
DISCUSSION AND CONCLUSIONS


Robotic treatment using a set of 4 devices significantly improved UL motor function, activities, and participation in subjects with subacute stroke to the same extent as a similar amount of conventional therapy. Video Abstract is available for more insights from the authors (see the Video, Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A291).",2020,"Both groups also had similar change in secondary measures, except for the Motricity Index, with better results for the robotic group (adjusted mean difference 4.42, P = 0.037).","['After Stroke', '247 subjects with subacute stroke', 'One hundred ninety subjects completed the posttreatment assessment, with a subset (n = 122) returning for follow-up evaluation', 'subjects with subacute stroke']","['conventional therapy', 'robotic UL', 'Upper Limb Robotic Rehabilitation']","['UL motor function, activities, and participation', 'Fugl-Meyer Assessment (FMA) score', 'Motricity Index', 'complete upper limb (UL) functional recovery', 'motor function, activities, and participation', 'Mean FMA score improvement']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451322', 'cui_str': 'Motricity index'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}]",247.0,0.165606,"Both groups also had similar change in secondary measures, except for the Motricity Index, with better results for the robotic group (adjusted mean difference 4.42, P = 0.037).","[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Aprile', 'Affiliation': ""IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy (I.A., A.C., S.L., C.P., A.M., S.G., G.S., E.L., D.P., L.P., M.C.C.); IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy (M.G., F.C., M.D., C.F.); Department of Geriatrics, Neurosciences and Orthopaedics, Università Cattolica del Sacro Cuore, Rome, Italy (L.P.); and The Biorobotics Institute, Scuola Superiore Sant'Anna, Pontedera, Pisa, Italy (M.C.C.).""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Germanotta', 'Affiliation': ''}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Cruciani', 'Affiliation': ''}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Loreti', 'Affiliation': ''}, {'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Pecchioli', 'Affiliation': ''}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Cecchi', 'Affiliation': ''}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Montesano', 'Affiliation': ''}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Galeri', 'Affiliation': ''}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Diverio', 'Affiliation': ''}, {'ForeName': 'Catuscia', 'Initials': 'C', 'LastName': 'Falsini', 'Affiliation': ''}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Speranza', 'Affiliation': ''}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Langone', 'Affiliation': ''}, {'ForeName': 'Dionysia', 'Initials': 'D', 'LastName': 'Papadopoulou', 'Affiliation': ''}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Padua', 'Affiliation': ''}, {'ForeName': 'Maria Chiara', 'Initials': 'MC', 'LastName': 'Carrozza', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of neurologic physical therapy : JNPT,['10.1097/NPT.0000000000000295']
2450,31834218,"Commentary on: ""Calling Out MS Fatigue: Feasibility and Preliminary Effects of a Pilot Randomized Telephone-Delivered Exercise Intervention for Multiple Sclerosis Fatigue"".",,2020,,['Multiple Sclerosis Fatigue'],['Telephone-Delivered Exercise Intervention'],[],"[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0231835,,"[{'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Backus', 'Affiliation': 'Shepherd Center (D.B.), Crawford Research Institute, Atlanta, Georgia; and Shepherd Center (A.B.), MS Institute, Atlanta, Georgia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Berry', 'Affiliation': ''}]",Journal of neurologic physical therapy : JNPT,['10.1097/NPT.0000000000000304']
2451,31834471,Contemporary application of autologous muscle-derived cells for urinary sphincter regeneration.,"OBJECTIVE


Stress urinary incontinence (SUI) remains a prevalent condition with substantial economic and quality-of-life impact. Treatment for incontinence historically culminates with invasive surgical procedures with recognized complication profiles. Innovative directions for SUI therapeutics are on the horizon, including the utilization of adult autologous muscle-derived cells for urinary sphincter regeneration (AMDC-USR). Herein, we visit fundamental concepts of innovative regenerative medicine technologies for urologic applications.
METHODS


Synopsis of contemporary literature review regarding adult autologous muscle-derived cells for urinary sphincter regeneration is presented.
RESULTS


Current published literature presents safety and efficacy data regarding AMDC-USR injection in 80 patients at 12-month follow-up. In these early studies, no long-term adverse events were reported and patients undergoing cellular injection at higher doses revealed at least 50% reduction in stress leaks and pad weight at 12-month follow-up. All dose groups demonstrated statistically significant improvement in patient-reported incontinence-specific quality-of-life scores at 12-month follow-up. Conclusions from the pooled analyses indicate that injection of AMDC-USR across a range of dosages appears safe. Efficacy data suggest a dose response with more patients responsive to the higher doses of AMDC-USR.
CONCLUSION


Applications for utilization of autologous cellular therapies for treatment of SUI, and conceivably multiple additional indications, are approaching realization. Multiple Phase III randomized, placebo-controlled studies for AMDC-USR are concluding or ongoing to launch this regenerative option for the millions of patients who may ultimately benefit.",2020,All dose groups demonstrated statistically significant improvement in patient-reported incontinence-specific quality-of-life scores at 12-month follow-up.,['incontinence historically culminates with invasive surgical procedures with recognized complication profiles'],"['autologous muscle-derived cells', 'AMDC-USR injection', 'placebo']","['stress leaks and pad weight', 'patient-reported incontinence-specific quality-of-life scores']","[{'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0205260', 'cui_str': 'Culminating'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0386133,All dose groups demonstrated statistically significant improvement in patient-reported incontinence-specific quality-of-life scores at 12-month follow-up.,"[{'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Kaufman', 'Affiliation': 'Department of Urology, Vanderbilt Medical Center, A-1302 Medical Center North, Nashville, TN, 37232, USA. melissa.kaufman@vumc.org.'}]",World journal of urology,['10.1007/s00345-019-03018-9']
2452,32791321,Guilt and expressive writing for reducing alcohol use in college students: Study protocol for a randomized control trial.,"The current proposed study aims to evaluate expressive writing as a novel intervention for reducing problematic drinking among college students. College students are at increased risk for alcohol misuse compared to other adults, and the development of efficacious intervention approaches is an urgent priority. The vast majority of individually focused brief interventions targeting college drinking have focused on personalized feedback approaches and recent innovations have largely been limited to refinements of this paradigm, which require large-scale assessment and intricate programming for implementation. The present research proposes expressive writing as a novel alternative, which has been used extensively in other domains but not as an alcohol intervention strategy. We propose a theoretically-based approach that incorporates expression of the self-conscious emotion of guilt and the written analogue of change talk as proposed mechanisms of intervention efficacy. We will also examine individual differences in guilt-proneness as a moderator of intervention efficacy. Heavy drinking college students (N = 600) will be randomly assigned to one of six expressive writing conditions based on a 2 (alcohol vs. distress) × 2 (guilt vs. no guilt) + 1 (control writing) + 1 (personalized feedback) design. Participation in the study involves completion of a screening assessment, a baseline assessment, three in-lab intervention sessions, post-intervention assessments, and follow-up assessments one-month, three-months, six months, and twelve-months later. If effective, this novel intervention approach would not require any pre-assessment or programming of personalized feedback, and would serve as a more easily disseminable alternative to existing approaches.",2020,"If effective, this novel intervention approach would not require any pre-assessment or programming of personalized feedback, and would serve as a more easily disseminable alternative to existing approaches.","['College students', 'Heavy drinking college students (N\u202f=\u202f600', 'college students']","['\u202f1 (control writing', 'Guilt and expressive writing', 'six expressive writing conditions based on a 2 (alcohol vs. distress']",[],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",[],600.0,0.018722,"If effective, this novel intervention approach would not require any pre-assessment or programming of personalized feedback, and would serve as a more easily disseminable alternative to existing approaches.","[{'ForeName': 'Clayton', 'Initials': 'C', 'LastName': 'Neighbors', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America.'}, {'ForeName': 'Jordanna Lembo', 'Initials': 'JL', 'LastName': 'Riggs', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America.'}, {'ForeName': 'Chelsie M', 'Initials': 'CM', 'LastName': 'Young', 'Affiliation': 'Department of Psychology, Rowan University, Glassboro, NJ, United States of America.'}, {'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Psychology, University of South Florida St. Petersburg, St. Petersburg, FL, United States of America.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Angosta', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America. Electronic address: jangosta@central.uh.edu.'}, {'ForeName': 'Pelin', 'Initials': 'P', 'LastName': 'Cunningham-Erdogdu', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America; Department of Psychology, University of Texas at Austin, Austin, TX, United States of America.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Department of Health Disparities Research, University of Texas, MD Anderson Cancer Center, Houston, TX, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106107']
2453,32791322,The Aging PLUS  trial: Design of a randomized controlled trial to increase physical activity in middle-aged and older adults.,"BACKGROUND


Negative views of aging (NVOA), low self-efficacy beliefs, and poor goal planning skills represent risk factors that undermine adults' motivation to engage in physical activity (PA). Targeting these three risk factors may motivate adults to become physically active.
OBJECTIVE


To assess the efficacy of Aging PLUS , a 4-week educational program that explicitly targets NVOA, low self-efficacy beliefs, and poor goal planning skills compared to a 4-week health education program. The study also examines the role of NVOA, self-efficacy beliefs, and goal planning as the mechanisms underlying change in PA.
DESIGN


This randomized controlled trial (RCT) utilizes the experimental medicine approach to assess change in PA as a function of modifying three risk factors. The RCT recruitment target includes 288 mostly sedentary adults ranging in age from 45 to 75 years.
METHODS


Eligible middle-aged and older adults are recruited through community sources. Participants are randomized to either the Aging PLUS  or the control group. Participants in both groups are enrolled in the trial for 8 months total, with four assessment points: Baseline (pre-test), Week 4 (immediate post-test), Week 8 (delayed post-test), and Month 6 (long-term follow-up). The intervention takes place over 4 consecutive weeks with 2-h sessions each week. PA engagement is the primary outcome variable. Positive changes in NVOA, self-efficacy beliefs, and goal planning are the intervention targets and hypothesized mediators of increases in PA.
SUMMARY


By utilizing a multi-component approach and targeting a cluster of psychological mechanisms, the Aging PLUS  program implements the experimental medicine approach to health behavior change.",2020,"Positive changes in NVOA, self-efficacy beliefs, and goal planning are the intervention targets and hypothesized mediators of increases in PA.
","['middle-aged and older adults', '288 mostly sedentary adults ranging in age from 45 to 75\u202fyears', 'Eligible middle-aged and older adults']",[],"['physical activity', 'Positive changes in NVOA, self-efficacy beliefs']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",288.0,0.0622321,"Positive changes in NVOA, self-efficacy beliefs, and goal planning are the intervention targets and hypothesized mediators of increases in PA.
","[{'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Diehl', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States. Electronic address: manfred.diehl@colostate.edu.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Nehrkorn-Bailey', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Thompson', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Kaigang', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Rebok', 'Affiliation': 'Department of Mental Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Roth', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, School of Medicine, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Shang-En', 'Initials': 'SE', 'LastName': 'Chung', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, School of Medicine, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Bland', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Skylar', 'Initials': 'S', 'LastName': 'Feltner', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Garrett', 'Initials': 'G', 'LastName': 'Forsyth', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Hulett', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'Berkeley', 'Initials': 'B', 'LastName': 'Klein', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Mars', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Martinez', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Mast', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Monasterio', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Moore', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'Hayden', 'Initials': 'H', 'LastName': 'Schoenberg', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Thomson', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'Han-Yun', 'Initials': 'HY', 'LastName': 'Tseng', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106105']
2454,32791393,A Prospective Randomized Control Study Comparing the Effects of Dermal Staples and Intradermal Sutures on Postoperative Scarring After Thyroidectomy.,"BACKGROUND


We compared cosmetic outcomes, pain intensity, and costs between dermal stapling and intradermal suturing in patients who underwent thyroidectomy through cervical incision.
PATIENTS AND METHODS


In total, 40 patients were randomly assigned to undergo thyroidectomy through a low cervical incision and dermal closure using either absorbable staples (n = 20, staple group) or interrupted intradermal sutures (n = 20, suture group). Wound complications, cosmetic outcomes (modified Stony Brook Scar Evaluation Scale [SBSES] and Manchester Scar Scale [MSS]), and pain intensity (visual analog scale) were assessed at 1, 4, 12, and 24 weeks postoperatively. The difference in total ""wound-closure cost"" between the two groups was also analyzed.
RESULTS


There were no wound-related complications and no significant differences in SBSES or MSS scores between the two groups (P = 0.609 and P = 0.141, respectively). However, the staple group had significantly higher SBSES scores, compared to the suture group, at 24 wk postoperatively (4.06 ± 0.94 versus 3.26 ± 1.24; P = 0.030, respectively); MSS scores were significantly lower in the staple group than in the suture group at 24 wk postoperatively (6.72 ± 1.27 versus 8.16 ± 2.17, respectively; P = 0.028). Visual analog scale scores were significantly lower in the suture group than in the staple group (P = 0.038). The total wound-closure cost was significantly higher in the staple group than in the suture group (137.10 ± 8.39 versus 81.79 ± 19.95 USD; P < 0.001).
CONCLUSIONS


When dermal staples were used, wound complications were absent and long-term cosmetic outcomes were superior; however, pain intensity was higher and the cost was greater, although healing was significantly more rapid, compared to intradermal sutures. Closure using absorbable dermal staples may be safe and effective for cervical incisions during thyroid surgery. Further studies with larger number of participants are needed to confirm our findings.",2020,"There were no wound-related complications and no significant differences in SBSES or MSS scores between the two groups (P = 0.609 and P = 0.141, respectively).","['patients who underwent thyroidectomy through cervical incision', '40 patients']","['thyroidectomy through a low cervical incision and dermal closure using either absorbable staples (n\xa0=\xa020, staple group) or interrupted intradermal sutures', 'Dermal Staples and Intradermal Sutures', 'dermal stapling and intradermal suturing']","['Postoperative Scarring', 'total wound-closure cost', 'total ""wound-closure cost', 'healing', 'pain intensity', 'MSS scores', 'wound complications', 'Wound complications, cosmetic outcomes (modified Stony Brook Scar Evaluation Scale [SBSES] and Manchester Scar Scale [MSS]), and pain intensity (visual analog scale', 'pain intensity, and costs', 'SBSES or MSS scores', 'Visual analog scale scores', 'SBSES scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0442944', 'cui_str': 'Incision of neck'}]","[{'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0442944', 'cui_str': 'Incision of neck'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0185012', 'cui_str': 'Closure by staple'}]","[{'cui': 'C0334150', 'cui_str': 'Surgical scar'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0024814', 'cui_str': 'Marinesco-Sjögren syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0003380', 'cui_str': 'Antimony'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",40.0,0.0378732,"There were no wound-related complications and no significant differences in SBSES or MSS scores between the two groups (P = 0.609 and P = 0.141, respectively).","[{'ForeName': 'Dohoe', 'Initials': 'D', 'LastName': 'Ku', 'Affiliation': 'Department of Surgery, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea.'}, {'ForeName': 'Do Hoon', 'Initials': 'DH', 'LastName': 'Koo', 'Affiliation': 'Department of Surgery, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea.'}, {'ForeName': 'Dong Sik', 'Initials': 'DS', 'LastName': 'Bae', 'Affiliation': 'Department of Surgery, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea. Electronic address: md.ds.bae@gmail.com.'}]",The Journal of surgical research,['10.1016/j.jss.2020.06.052']
2455,32791434,Factors associated with readiness to quit smoking among young adults enrolled in a Facebook-based tobacco and alcohol intervention study.,"INTRODUCTION


Young adults who smoke cigarettes often report heavy episodic drinking (HED) and co-use of other psychoactive substances which may complicate efforts to quit cigarette smoking. The current study examined factors associated with readiness to quit cigarette smoking among young adults who smoke and engage in HED.
METHODS


One hundred seventy-nine young adults aged 18 to 25 who reported regular cigarette smoking and past month HED enrolled in the 90-day Facebook-based Smoking Tobacco and Drinking (STAND) intervention study. Analyses compared baseline differences in patterns of cigarette smoking and alcohol and cannabis use, thoughts about abstinence, use of nicotine replacement therapy (NRT), sociodemographic characteristics, and other health behaviors between participants who were ready to quit cigarette smoking in the next 30 days and those who were not.
RESULTS


Participants were 40.2% female, 49.7% male, 10.1% non-binary, and 80.4% Non-Hispanic White. They reported on average moderate nicotine dependence (FTCD), moderate risk for alcohol use disorder (AUDIT), and occasional or regular cannabis use. Readiness to quit cigarette smoking in the next 30 days (33.5%) was positively associated with age (p = .021), NRT use in the past 30 days (p = .037) and perceived importance to also reduce alcohol use (p = .033).
CONCLUSIONS


Findings indicate that readiness to quit cigarette smoking among young adults who drink is positively associated with importance to reduce alcohol use, but not with use patterns or levels of dependence. Interventions addressing polysubstance use may be better suited to help young adults reduce or quit cigarette smoking once they signal readiness for behavior change.",2020,"Readiness to quit cigarette smoking in the next 30 days (33.5%) was positively associated with age (p = .021), NRT use in the past 30 days (p = .037) and perceived importance to also reduce alcohol use (p = .033).
","['One hundred seventy-nine young adults aged 18 to 25 who reported regular cigarette smoking and past month HED enrolled in the 90-day Facebook-based Smoking Tobacco and Drinking (STAND) intervention study', 'young adults who smoke and engage in HED', 'young adults enrolled in a Facebook-based tobacco and alcohol intervention study', 'Young adults who smoke cigarettes often report heavy episodic drinking (HED', 'Participants were 40.2% female, 49.7% male, 10.1% non-binary, and 80.4% Non-Hispanic White']",[],"['Readiness to quit cigarette smoking', 'cigarette smoking and alcohol and cannabis use, thoughts about abstinence, use of nicotine replacement therapy (NRT), sociodemographic characteristics, and other health behaviors']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439994', 'cui_str': 'Tobacco smoke'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]",[],"[{'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",179.0,0.016447,"Readiness to quit cigarette smoking in the next 30 days (33.5%) was positively associated with age (p = .021), NRT use in the past 30 days (p = .037) and perceived importance to also reduce alcohol use (p = .033).
","[{'ForeName': 'Larissa J', 'Initials': 'LJ', 'LastName': 'Maier', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, CA, United States; Early Postdoc. Mobility Grantee (P2ZHP1_174812), Swiss National Science Foundation, Bern, Switzerland. Electronic address: larissa.maier@ucsf.edu.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Ramo', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, CA, United States. Electronic address: Danielle.Ramo@ucsf.edu.'}, {'ForeName': 'Manpreet', 'Initials': 'M', 'LastName': 'Kaur', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, CA, United States. Electronic address: manpreetkaurkh@gmail.com.'}, {'ForeName': 'Meredith C', 'Initials': 'MC', 'LastName': 'Meacham', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, CA, United States. Electronic address: meredith.meacham@ucsf.edu.'}, {'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Satre', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, CA, United States; Kaiser Permanente Northern California, Division of Research, Oakland, CA, United States. Electronic address: derek.satre@ucsf.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106524']
2456,32791499,Use of a Supportive Kidney Care Video Decision Aid in Older Patients: A Randomized Controlled Trial.,"BACKGROUND


There are few studies of patient-facing decision aids that include supportive kidney care as an option. We tested the efficacy of a video decision aid on knowledge of supportive kidney care among older patients with advanced CKD.
METHODS


Participants (age ≥ 65 years with advanced CKD) were randomized to receive verbal or video education. Primary outcome was knowledge of supportive kidney care (score range 0-3). Secondary outcomes included preference for supportive kidney care, and satisfaction and acceptability of the video.
RESULTS


Among all participants (n = 100), knowledge of supportive kidney care increased significantly after receiving education (p < 0.01); however, there was no difference between study arms (p = 0.68). There was no difference in preference for supportive kidney care between study arms (p = 0.49). In adjusted analyses, total health literacy score (aOR 1.08 [95% CI: 1.003-1.165]) and nephrologists' answer of ""No"" to the Surprise Question (aOR 4.87 [95% CI: 1.22-19.43]) were associated with preference for supportive kidney care. Most felt comfortable watching the video (96%), felt the content was helpful (96%), and would recommend the video to others (96%).
CONCLUSIONS


Among older patients with advanced CKD, we did not detect a significant difference between an educational verbal script and a video decision aid in improving knowledge of supportive kidney care or preferences. However, patients who received video education reported high satisfaction and acceptability ratings. Future research will determine the effectiveness of a supportive kidney care video decision aid on real-world patient outcomes.
TRIAL REGISTRATION


NCT02698722 (ClinicalTrials.gov).",2020,"In adjusted analyses, total health literacy score (aOR 1.08 [95% CI: 1.003-1.165]) and nephrologists' answer of ""No"" to the Surprise Question (aOR 4.87 [95% CI: 1.22-19.43]) were associated with preference for supportive kidney care.","['Participants (age ≥ 65 years with advanced CKD', 'Older Patients', 'older patients with advanced CKD']","['verbal or video education', 'video decision aid', 'Supportive Kidney Care Video Decision Aid']","['knowledge of supportive kidney care', 'satisfaction and acceptability ratings', 'total health literacy score', 'preference for supportive kidney care', 'educational verbal script', 'knowledge of supportive kidney care (score range 0-3', 'preference for supportive kidney care, and satisfaction and acceptability of the video']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0042655', 'cui_str': 'Video'}]",100.0,0.12439,"In adjusted analyses, total health literacy score (aOR 1.08 [95% CI: 1.003-1.165]) and nephrologists' answer of ""No"" to the Surprise Question (aOR 4.87 [95% CI: 1.22-19.43]) were associated with preference for supportive kidney care.","[{'ForeName': 'Nwamaka D', 'Initials': 'ND', 'LastName': 'Eneanya', 'Affiliation': 'Renal-Electrolyte Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA, nwamaka.eneanya@pennmedicine.upenn.edu.'}, {'ForeName': 'Shananssa G', 'Initials': 'SG', 'LastName': 'Percy', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Massachusetts General Hospital, Harvard Medical School Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Taylor L', 'Initials': 'TL', 'LastName': 'Stallings', 'Affiliation': 'Palliative and Advanced Illness Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Palliative and Advanced Illness Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'David J R', 'Initials': 'DJR', 'LastName': 'Steele', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Massachusetts General Hospital, Harvard Medical School Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Germain', 'Affiliation': 'Division of Nephrology, Baystate Medical Center, University of Massachusetts Medical School - Baystate, Springfield, Massachusetts, USA.'}, {'ForeName': 'Jane O', 'Initials': 'JO', 'LastName': 'Schell', 'Affiliation': 'Division of Renal-Electrolyte, Department of General Medicine, Section of Palliative Care and Medical Ethics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Paasche-Orlow', 'Affiliation': 'Section of General Internal Medicine, Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Angelo E', 'Initials': 'AE', 'LastName': 'Volandes', 'Affiliation': 'Division of General Medicine, Department of Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}]",American journal of nephrology,['10.1159/000509711']
2457,32791610,[Efficacy analysis of use of absorbable sinus drug stents in functional endoscopic sinus surgery].,"Objective: To explore the efficacy of functional endoscopic sinus surgery（FESS） with an absorbable sinus drug stent in the treatment of chronic sinusitis.  Method: 107 patients with chronic sinusitis who underwent FESS were divided into two groups: 58 patients were set as stent group who were treated with sinus drug elution during surgery; 49 patients who did not receive a sinus drug stent were included in the non-stent group. The same postoperative treatment were used in the two groups. The patients were followed up for 1 month and reviewed 3 months after surgery. Efficacy is mainly evaluated by endoscopy. The evaluation indicators include whether the sinus mucosa is congested and edema, whether there is adhesion in the middle turbinate, whether vesicles or polyp-like mucosa are formed, whether the sinus mouth is stenosed or reoccluded, whether the sinus mucosa is epithelialized, and whether the patient had intervention after surgery.  Result: Stents were successfully implanted in 58 patients in the stent group. The difference of the above six indexes between the stent group and the non-stent group was statistically significant at 1 month after operation. The postoperative complication rate and postoperative intervention rate were significantly lower in the stent group than in the control group（ P <0.01）, the incidence of sinus mucosal epithelialization in the stent group was significantly higher than that in the non-stent group（ P <0.01）. The sinus mucosal epithelialization were all completed in both groups after 3 months of surgery. The postoperative complication rate and postoperative intervention rate were significantly lower in the stent group than in the non-stent group（ P <0.05 or  P <0.01）.  Conclusion: FESS combined with the absorption of sinus drug stents for the treatment of chronic sinusitis is safe and effective which can control the complications further after surgery while relieving the clinical symptoms of patients with sinusitis effectively.",2020,The postoperative complication rate and postoperative intervention rate were significantly lower in the stent group than in the non-stent group（ P <0.05 or  P <0.01）.  ,"['107 patients with chronic sinusitis who underwent FESS', 'functional endoscopic sinus surgery', '58 patients in the stent group']","['absorbable sinus drug stents', 'functional endoscopic sinus surgery（FESS） with an absorbable sinus drug stent', 'sinus drug elution during surgery; 49 patients who did not receive a sinus drug stent', 'FESS']","['sinus mucosal epithelialization', 'Efficacy', 'postoperative complication rate and postoperative intervention rate', 'incidence of sinus mucosal epithelialization']","[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0334029', 'cui_str': 'Epithelialization'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",107.0,0.0199735,The postoperative complication rate and postoperative intervention rate were significantly lower in the stent group than in the non-stent group（ P <0.05 or  P <0.01）.  ,"[{'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Wan', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，the Affiliated Chaohu Hospital of Anhui Medical University，Heifei，238000，China.'}, {'ForeName': 'Longsheng', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，the Affiliated Chaohu Hospital of Anhui Medical University，Heifei，238000，China.'}, {'ForeName': 'Panpan', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，the Affiliated Chaohu Hospital of Anhui Medical University，Heifei，238000，China.'}, {'ForeName': 'Junkang', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，the Affiliated Chaohu Hospital of Anhui Medical University，Heifei，238000，China.'}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.05.007']
2458,32791616,[Clinical observation of the anti-reflux treatment for the chronic pharyngitis patients with the reflux finding score from 8 to 10].,"Objective: To evaluate the anti-reflux treatment efficacy for the chronic pharyngitis patients with the reflux finding score（RFS） from 8-10.  Method: One hundred and twelve patients with clinical diagnosis of chronic pharyngitis and RFS score of 8-10 were randomly divided into control and treatment groups. The treantment group was given the proton pump inhibitors, gastrointestinal motility drugs and the traditional Chinese patent drugs（treatment group）. The control group was given only the traditional Chinese patent drugs（control group）.  Result: The visual analogue scale（VAS） of the patients in treatment group declined significantly after treatment. The efficacy of treatment group was significantly higher than that of control group（77.36% vs 30.61%,  P <0.01）.  Conclusion: For the patients with chronic pharyngitis with RFS 8-10, anti-reflux treatment should be used together with traditional Chinese patent drugs.",2020,"The efficacy of treatment group was significantly higher than that of control group（77.36% vs 30.61%,  P <0.01）.  ","['chronic pharyngitis patients with the reflux finding score from 8 to 10', 'chronic pharyngitis patients with the reflux finding score（RFS） from 8-10', 'One hundred and twelve patients with clinical diagnosis of chronic pharyngitis and RFS score of 8-10']","['proton pump inhibitors, gastrointestinal motility drugs and the traditional Chinese patent drugs（treatment group）', 'traditional Chinese patent drugs（control group）', 'anti-reflux treatment']",['visual analogue scale（VAS）'],"[{'cui': 'C0155825', 'cui_str': 'Chronic pharyngitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}]","[{'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0017184', 'cui_str': 'Gastrointestinal Motility'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030650', 'cui_str': 'Patents'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}]",112.0,0.0147976,"The efficacy of treatment group was significantly higher than that of control group（77.36% vs 30.61%,  P <0.01）.  ","[{'ForeName': 'Suyi', 'Initials': 'S', 'LastName': 'Zeng', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，Affiliated Hospital of Chengdu University，Chengdu，610081，China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，Affiliated Hospital of Chengdu University，Chengdu，610081，China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，Affiliated Hospital of Chengdu University，Chengdu，610081，China.'}, {'ForeName': 'De', 'Initials': '', 'LastName': 'Lan', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，Affiliated Hospital of Chengdu University，Chengdu，610081，China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，Affiliated Hospital of Chengdu University，Chengdu，610081，China.'}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.05.013']
2459,32791618,[Evaluation of the effectiveness of immersive virtual reality-based exercise system for vestibular rehabilitation].,"Objective: To evaluate the efficacy of virtual reality technology assisted vestibular rehabilitation training（VRT） in treating chronic vestibular dysfunction patients.  Method: Ninety-eight vestibular dysfunction patients were assigned into the experimental group（ n =73） and the control group（ n =25） using mechanical sampling. The experimental group received immersive virtual reality assisted VRT treatment, while the control group received conventional VRT treatment. Chinese vertigo symptom scale（VSS-C） was used to measure vertigo symptoms before treatment and 12 weeks post-treatment. Balance feedback instrument was used to measure the center of pressure（COP）, maximum oscillation length（MOL） and COP envelope area（EA） which smaller numbers indicating better balance functions. Analysis of variance and Fisher's exact test were performed using SPSS 20.0 software to compare mean values and frequencies, respectively.  Result: ①Before treatment as baseline, there were no statistically significant differences in the total score of VSS-C scale, balance correlation and anxiety correlation score between the two groups. Total score and balance related score of experimental group were significantly different between before and after treatment（ P <0.01）, while no statistically significant difference in anxiety related scores. After treatment, there were statistically significant differences in total VSS-C score（ P <0.01） and balance correlation score（ P <0.05） between the two groups, while no statistically significant difference in anxiety correlation score. ②After 12 weeks of treatment, there were statistically significant differences between MOL and EA in open-eye state（ P <0.01）, but no statistically significant difference in close-eye state between two groups.  Conclusion: The introduction of VR technology by VRT can provide interesting interactions for patients in training and encourage patients to actively participate in various repetitive rehabilitation exercises that are boring, achieving good effect. The effect of VR on subjective balance rehabilitation without visual impairment is better than that of conventional.",2020,"Total score and balance related score of experimental group were significantly different between before and after treatment（ P <0.01）, while no statistically significant difference in anxiety related scores.","['vestibular rehabilitation', 'Method: Ninety-eight vestibular dysfunction patients', 'chronic vestibular dysfunction patients']","['virtual reality technology assisted vestibular rehabilitation training（VRT）', 'control group（ n =25） using mechanical sampling', 'VR', 'immersive virtual reality assisted VRT treatment', 'immersive virtual reality-based exercise system', 'conventional VRT treatment']","['MOL and EA', 'vertigo symptoms', 'anxiety related scores', 'total score of VSS-C scale, balance correlation and anxiety correlation score', 'anxiety correlation score', 'close-eye state', 'Total score and balance related score', 'total VSS-C score']","[{'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1301808', 'cui_str': 'State'}]",98.0,0.0230778,"Total score and balance related score of experimental group were significantly different between before and after treatment（ P <0.01）, while no statistically significant difference in anxiety related scores.","[{'ForeName': 'Yuenong', 'Initials': 'Y', 'LastName': 'Jiao', 'Affiliation': ""Institute of Otolaryngology Head and Neck Surgery，Guangzhou Medical University；Department of Otolaryngology Head and Neck Surgery，Otolaryngology Head and Neck Surgery Hospital of Guangzhou；Department of Otolaryngology Head and Neck Surgery，Guangzhou 12th People's Hospital，Guangzhou，510620，China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""Institute of Otolaryngology Head and Neck Surgery，Guangzhou Medical University；Department of Otolaryngology Head and Neck Surgery，Otolaryngology Head and Neck Surgery Hospital of Guangzhou；Department of Otolaryngology Head and Neck Surgery，Guangzhou 12th People's Hospital，Guangzhou，510620，China.""}, {'ForeName': 'Xinrui', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Institute of Otolaryngology Head and Neck Surgery，Guangzhou Medical University；Department of Otolaryngology Head and Neck Surgery，Otolaryngology Head and Neck Surgery Hospital of Guangzhou；Department of Otolaryngology Head and Neck Surgery，Guangzhou 12th People's Hospital，Guangzhou，510620，China.""}, {'ForeName': 'Yunwen', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Institute of Otolaryngology Head and Neck Surgery，Guangzhou Medical University；Department of Otolaryngology Head and Neck Surgery，Otolaryngology Head and Neck Surgery Hospital of Guangzhou；Department of Otolaryngology Head and Neck Surgery，Guangzhou 12th People's Hospital，Guangzhou，510620，China.""}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Institute of Otolaryngology Head and Neck Surgery，Guangzhou Medical University；Department of Otolaryngology Head and Neck Surgery，Otolaryngology Head and Neck Surgery Hospital of Guangzhou；Department of Otolaryngology Head and Neck Surgery，Guangzhou 12th People's Hospital，Guangzhou，510620，China.""}, {'ForeName': 'Zijian', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': ""Institute of Otolaryngology Head and Neck Surgery，Guangzhou Medical University；Department of Otolaryngology Head and Neck Surgery，Otolaryngology Head and Neck Surgery Hospital of Guangzhou；Department of Otolaryngology Head and Neck Surgery，Guangzhou 12th People's Hospital，Guangzhou，510620，China.""}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.05.015']
2460,32791641,[Application of impulse-radio ultra-wideband radar as a non-contact portable monitoring device for the diagnosis of obstructive sleep apnea].,"Objective: To compare the effect of impulse-radio ultrawideband（IR-UWB） radar technology and polysomnography（PSG） in sleep assessment.  Method: A total of 79 OSA patients were randomly divided into two groups: 40 patients in group A received PSG and IR-UWB, and 39 patients in group B received micromovement sensitive mattress（MSM） and IR-UWB. Pearson correlation and ROC curve were used for statistics.  Result: AHI PSG and AHI MSM were significantly correlated with AHI IR-UWB（ r =0.91,  P ＝0.00;  r =0.92,  P ＝0.00）. Bland-Altman analysis showed that AHI IR-UWB value was highly consistent with AHI PSG value（95.00%）, and AHI IR-UWB value（97.44%）. The sensitivity and specificity of AHI IR-UWB compared with PSG were 70.40% and 89.90%, respectively. The area under ROC curve was 0.915.  Conclusion: IR-UWB has a high diagnostic value for adult OSA in terms of minimum blood oxygen saturation, average blood oxygen saturation, average number of central sleep apnea, average number of complex sleep apnea, average heart rate, sleep efficiency, REM sleep duration, average AHI, etc. It is an economic and practical sleep evaluation tool.",2020,"IR-UWB has a high diagnostic value for adult OSA in terms of minimum blood oxygen saturation, average blood oxygen saturation, average number of central sleep apnea, average number of complex sleep apnea, average heart rate, sleep efficiency, REM sleep duration, average AHI, etc.","['obstructive sleep apnea', '79 OSA patients']","['impulse-radio ultra-wideband radar', 'impulse-radio ultrawideband（IR-UWB） radar technology and polysomnography（PSG', 'PSG and IR-UWB, and 39 patients in group B received micromovement sensitive mattress（MSM） and IR-UWB']","['sensitivity and specificity of AHI IR-UWB', 'area under ROC curve', 'minimum blood oxygen saturation, average blood oxygen saturation, average number of central sleep apnea, average number of complex sleep apnea, average heart rate, sleep efficiency, REM sleep duration, average AHI, etc', 'AHI IR-UWB value', 'AHI PSG and AHI MSM']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0034513', 'cui_str': 'Radar'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]","[{'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0035787', 'cui_str': 'ROC Analysis'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0520680', 'cui_str': 'Apnea, Central Sleep'}, {'cui': 'C0338495', 'cui_str': 'Mixed sleep apnea'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0037322', 'cui_str': 'Rapid eye movement sleep'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0058231', 'cui_str': 'methylsulfonylmethane'}]",79.0,0.0111517,"IR-UWB has a high diagnostic value for adult OSA in terms of minimum blood oxygen saturation, average blood oxygen saturation, average number of central sleep apnea, average number of complex sleep apnea, average heart rate, sleep efficiency, REM sleep duration, average AHI, etc.","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Feng', 'Affiliation': 'Department of Otorhinolaryngology，Qilu Hospital of Shandong University，NHC Key Laboratory of Otorhinolaryngology，Shandong University，Jinan，250014，China.'}, {'ForeName': 'Huidong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Otorhinolaryngology，Qilu Hospital of Shandong University，NHC Key Laboratory of Otorhinolaryngology，Shandong University，Jinan，250014，China.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Otorhinolaryngology，Qilu Hospital of Shandong University，NHC Key Laboratory of Otorhinolaryngology，Shandong University，Jinan，250014，China.'}, {'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': 'Department of Otorhinolaryngology，Qilu Hospital of Shandong University，NHC Key Laboratory of Otorhinolaryngology，Shandong University，Jinan，250014，China.'}, {'ForeName': 'Feilun', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Department of Otorhinolaryngology，Qilu Hospital of Shandong University，NHC Key Laboratory of Otorhinolaryngology，Shandong University，Jinan，250014，China.'}, {'ForeName': 'Juanjuan', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'Department of Otorhinolaryngology，Qilu Hospital of Shandong University，NHC Key Laboratory of Otorhinolaryngology，Shandong University，Jinan，250014，China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Otorhinolaryngology，Qilu Hospital of Shandong University，NHC Key Laboratory of Otorhinolaryngology，Shandong University，Jinan，250014，China.'}, {'ForeName': 'Yanzhong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Otorhinolaryngology，Qilu Hospital of Shandong University，NHC Key Laboratory of Otorhinolaryngology，Shandong University，Jinan，250014，China.'}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.07.014']
2461,32791681,"Effect of ""Tonifying Kidney and Invigorating Brain"" acupuncture in children with spastic cerebral palsy analyzed by multi-modality MRI combined with dynamic electroencephalogram.","INTRODUCTION


Cerebral palsy is the most common motor disability of childhood. Spastic cerebral palsy accounts for 60% to 70% of cases. Research has shown that acupuncture can improve the quality of life of children with cerebral palsy, but the mechanism of action remains unclear. This study aims to determine the effectiveness of acupuncture for treatment of children with spastic cerebral palsy and to assess the value of multimodal magnetic resonance imaging (MRI) and ambulatory electroencephalogram (EEG) for evaluation of treatment effect.
METHODS AND ANALYSIS


This randomized controlled trial will enroll a total of 72 children with CP from 2 hospitals-Jiangsu Province Hospital of Chinese Medicine and Nanjing State Hospital of Pediatric-with 36 participants from each hospital. Patients will be randomly assigned (1:1 ratio) to receive ""Tonifying Kidney and Invigorating Brain"" acupuncture treatment plus standardized physical rehabilitation treatment (treatment group) or only standardized physical rehabilitation (control group). All participants will receive 3 treatment sessions per week for 3 consecutive months; they will then be followed up for another 3 months. The primary outcome measures will include multimodal magnetic resonance imaging (MRI), ambulatory electroencephalogram (EEG), and Gesell Developmental Diagnostic Schedules. The secondary outcome measures will include Gross Motor Function Classification System (GMFCS), Gross Motor Function Measure (GMFM), Functional Independence Measure (WeeFIM), and Modified Ashworth Scale score. Outcome measures (including primary and secondary outcome measures) were collected at the baseline, 3 months and 6 months prior to the intervention.Ethics and dissemination PATIENTS CONSENT:: Obtained.
ETHICS APPROVAL


The central independent ethics committee of Jiangsu Province Hospital of Traditional Chinese Medicine approved the protocol (2017NL-115-02).
SAFETY CONSIDERATIONS


Routine blood tests and liver and kidney function tests will be conducted to exclude patients with severe heart, liver, or kidney diseases. The same examinations will be performed again at the end of the study to detect any possible side effects. Possible acupuncture-related adverse events (e.g., fainting, needle stick injury, local infection, subcutaneous hematoma, and low-grade fever) will be documented. Serious adverse events will be reported to the principal investigator immediately. All unexpected and unintended responses, even those not necessarily related to the acupuncture intervention, will be documented as adverse events.
CASE DROPOUT MANAGEMENT


Participants have a right to withdraw from the study at any time if they feel uncomfortable upon receiving the treatments or being diagnosed with serious complications or diseases. They will then be referred to the preferred department for further treatment and management. If cases of dropout, the researcher need to contact the participant to reason the problem out, collect and record all the necessary assessments on the last visit as well as the date of last visit. All data available until the date of withdrawal will be stored for further statistical analysis.
DISCUSSION


This research is being conducted to assess the value of acupuncture as an intervention for rehabilitation of children with spastic cerebral palsy and also to evaluate the usefulness of multimodal MRI and ambulatory EEG for identifying changes in brain function.
TRIAL REGISTRATION


This trial is registered with Chinese Clinical Trials Register, ChiCTR 1900024546 (registered 15 July 2019; retrospective registration, http://www.chictr.org.cn/showproj.aspx?proj=35763).",2020,"Possible acupuncture-related adverse events (e.g., fainting, needle stick injury, local infection, subcutaneous hematoma, and low-grade fever) will be documented.","['children with cerebral palsy', 'patients with severe heart, liver, or kidney diseases', 'children with spastic cerebral palsy analyzed by multi-modality MRI combined with dynamic electroencephalogram', '72 children with CP from 2 hospitals-Jiangsu Province Hospital of Chinese Medicine and Nanjing State Hospital of Pediatric-with 36 participants from each hospital', 'children with spastic cerebral palsy']","['Tonifying Kidney and Invigorating Brain"" acupuncture treatment plus standardized physical rehabilitation treatment (treatment group) or only standardized physical rehabilitation (control group', 'acupuncture', 'multimodal magnetic resonance imaging (MRI) and ambulatory electroencephalogram (EEG', 'Tonifying Kidney and Invigorating Brain"" acupuncture']","['quality of life', 'Spastic cerebral palsy', 'Gross Motor Function Classification System (GMFCS), Gross Motor Function Measure (GMFM), Functional Independence Measure (WeeFIM), and Modified Ashworth Scale score', 'multimodal magnetic resonance imaging (MRI), ambulatory electroencephalogram (EEG), and Gesell Developmental Diagnostic Schedules', 'adverse events (e.g., fainting, needle stick injury, local infection, subcutaneous hematoma, and low-grade fever']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0020026', 'cui_str': 'State Hospitals'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0430799', 'cui_str': 'Ambulatory EEG'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0430799', 'cui_str': 'Ambulatory EEG'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0085178', 'cui_str': 'Injuries, Needlestick'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0520532', 'cui_str': 'Subcutaneous hematoma'}, {'cui': 'C0239574', 'cui_str': 'Low grade pyrexia'}]",72.0,0.0858516,"Possible acupuncture-related adverse events (e.g., fainting, needle stick injury, local infection, subcutaneous hematoma, and low-grade fever) will be documented.","[{'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': ""aDepartment of Acupuncture, Jiangsu Province Hospital of Traditional Chinese Medicine, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine bNanjing University of Traditional Chinese Medicine cChildren's Hospital of Nanjing Medical University, Nanjing, China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Bao', 'Affiliation': ''}, {'ForeName': 'Yan-Xia', 'Initials': 'YX', 'LastName': 'Geng', 'Affiliation': ''}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Elsie Sin May', 'Initials': 'ESM', 'LastName': 'Teo', 'Affiliation': ''}, {'ForeName': 'Jan-Bing', 'Initials': 'JB', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Yan-Cai', 'Initials': 'YC', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Meng-Qian', 'Initials': 'MQ', 'LastName': 'Yuan', 'Affiliation': ''}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Zou', 'Affiliation': ''}, {'ForeName': 'Ping-Ping', 'Initials': 'PP', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Li-Li', 'Initials': 'LL', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021082']
2462,32791690,Effect of digital storytelling intervention on burnout thoughts of adolescent: Athletes with disabilities.,"BACKGROUND/OBJECTIVE


Both athletes with and without disabilities can develop burnout symptoms. However, athletes with disabilities may face different or more challenges compared to their counterparts without disabilities. The present study aimed at ascertaining the effect of digital storytelling intervention on burnout thoughts of adolescent-athletes with disabilities.
METHOD


This study is a randomized controlled trial involving a total of 171 adolescent-athletes with disabilities who showed a high degree of burnout symptoms. These adolescent-athletes were randomly assigned to either an intervention group (n = 85) or a waitlisted control group (n = 86). The treatment intervention for the adolescent-athletes was digital stories which were created based on the framework of rational emotive behaviour therapy (REBT). The Athlete Burnout Questionnaire was used for gathering of data at three different times (baseline, post-test and follow up). Data were analyzed using repeated measure analysis of variance at a significant level of 0.05.
RESULTS


Results showed that the digital storytelling intervention based on REBT significantly reduced burnout thoughts among disabled adolescent-athletes in the intervention group compared to athletes in the waitlisted control group as measured by the Athlete Burnout Questionnaire. Additionally, at follow-up evaluation, it was observed that the decrease in burnout scores was maintained by those athletes in the digital storytelling intervention.
CONCLUSION


Digital storytelling intervention based on rational emotive behaviour therapy shows great potentials in addressing burnout among adolescent-athletes with disabilities.",2020,"RESULTS


Results showed that the digital storytelling intervention based on REBT significantly reduced burnout thoughts among disabled adolescent-athletes in the intervention group compared to athletes in the waitlisted control group as measured by the Athlete Burnout Questionnaire.","['adolescent: Athletes with disabilities', 'adolescent-athletes with disabilities', '171 adolescent-athletes with disabilities who showed a high degree of burnout symptoms', 'adolescent-athletes']","['Digital storytelling intervention', 'intervention group (n\u200a=\u200a85) or a waitlisted control group', 'digital storytelling intervention', 'REBT']",['burnout scores'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",171.0,0.0186893,"RESULTS


Results showed that the digital storytelling intervention based on REBT significantly reduced burnout thoughts among disabled adolescent-athletes in the intervention group compared to athletes in the waitlisted control group as measured by the Athlete Burnout Questionnaire.","[{'ForeName': 'Theresa Onyema', 'Initials': 'TO', 'LastName': 'Ofoegbu', 'Affiliation': 'aDepartment of Arts Education, University of Nigeria, Nsukka, P.M.B. 410001, Enugu State, Nigeria bHealth Economics, Management and Policy Research Unit, Department of Health Sciences, Alex-Ekwueme Federal University Ndufu-Alike Ikwo, Ebonyi State, Nigeria cDepartment of Educational Foundations, University of Nigeria, Nsukka, P.M.B. 410001, Enugu State, Nigeria dDepartment Human Kinetics and Health Education, University of Nigeria, Nsukka, P.M.B. 410001, Enugu State, Nigeria eDepartment of Sociology/Criminology & Security Studies, Alex-Ekwueme Federal University Ndufu Alike Ikwo, Ebonyi State, Nigeria fDepartment of Accountancy/Business Administration/Banking and Finance, Alex-Ekwueme Federal University Ndufu-Alike Ikwo, Ebonyi State, Nigeria gDepartment of Haematology and Blood Transfusion, Alex-Ekwueme Federal University Teaching Hospital Abakaliki, Ebonyi State, Nigeria.'}, {'ForeName': 'Uche D', 'Initials': 'UD', 'LastName': 'Asogwa', 'Affiliation': ''}, {'ForeName': 'Chimaobi Samuel', 'Initials': 'CS', 'LastName': 'Ogbonna', 'Affiliation': ''}, {'ForeName': 'Henry E', 'Initials': 'HE', 'LastName': 'Aloh', 'Affiliation': ''}, {'ForeName': 'Chiedu', 'Initials': 'C', 'LastName': 'Eseadi', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Eskay', 'Affiliation': ''}, {'ForeName': 'Godfrey C', 'Initials': 'GC', 'LastName': 'Nji', 'Affiliation': ''}, {'ForeName': 'Oliver Rotachukwu', 'Initials': 'OR', 'LastName': 'Ngwoke', 'Affiliation': ''}, {'ForeName': 'Christian Iheanacho', 'Initials': 'CI', 'LastName': 'Agboti', 'Affiliation': ''}, {'ForeName': 'Robert Azu', 'Initials': 'RA', 'LastName': 'Nnachi', 'Affiliation': ''}, {'ForeName': 'Oluomachi Charity', 'Initials': 'OC', 'LastName': 'Nnachi', 'Affiliation': ''}, {'ForeName': 'Mkpoikanke S', 'Initials': 'MS', 'LastName': 'Otu', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021164']
2463,32791692,"Effects and safety of intranasal phototherapy for allergic rhinitis: Study protocol for a single-center, randomized, parallel (acupuncture-controlled), open-label, investigator-initiated, pilot study.","INTRODUCTION


Allergic rhinitis (AR) is an immunoglobulin E (Ig E)-mediated inflammatory disease. Intranasal phototherapy is a promising treatment modality because it has a profound immunosuppressive effect, but the evidence of its use for AR is insufficient. Therefore, rigorously designed randomized controlled trials (RCTs) are needed. Our objective is to describe the protocol for an RCT to assess the effects and safety of intranasal phototherapy for the treatment of AR.
METHODS AND ANALYSIS


This is a study protocol for a single-center, randomized, parallel (acupuncture-controlled), open-label, investigator-initiated, pilot study. A total of 80 patients with AR will be randomly assigned to the intranasal phototherapy or acupuncture group at a 1:1 ratio. The participants will receive intranasal phototherapy with medical or acupuncture treatment for 20 minutes, 3 times a week for 4 weeks. The primary outcome will be the mean change in the total nasal symptom score (TNSS) from baseline to 4 weeks. The secondary outcomes will include the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score, Nasal Endoscopy Index, total serum immunoglobulin E (Ig E) level and eosinophil count.
DISCUSSION


The findings of this study will provide the basis for the design and implementation of RCTs investigating the effects and safety of intranasal phototherapy for AR. Additionally, it will provide preliminary evidence of intranasal phototherapy for use in AR.
TRIAL REGISTRATION


This study was registered at the Korean National Clinical Trial Registry, Clinical Research Information Service (KCT0004079).",2020,The primary outcome will be the mean change in the total nasal symptom score (TNSS) from baseline to 4 weeks.,"['allergic rhinitis', '80 patients with AR']","['intranasal phototherapy', 'Intranasal phototherapy', 'intranasal phototherapy with medical or acupuncture', 'intranasal phototherapy or acupuncture']","['Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score, Nasal Endoscopy Index, total serum immunoglobulin E (Ig E) level and eosinophil count', 'mean change in the total nasal symptom score (TNSS']","[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C5190490', 'cui_str': 'Intranasal phototherapy'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0189024', 'cui_str': 'Endoscopy of nose'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0856520', 'cui_str': 'Serum immunoglobulin E'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}]",80.0,0.125628,The primary outcome will be the mean change in the total nasal symptom score (TNSS) from baseline to 4 weeks.,"[{'ForeName': 'Jeongin', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'aDepartment of Ophthalmology, Otolaryngology, and Dermatology, College of Korean Medicine, Woo-Suk University, Jeonju bDepartment of Oriental Rehabilitation, National Rehabilitation Center, Seoul cClinical Medicine Division, Korea Institute of Oriental Medicine dFuture Medicine Division, Korea Institute of Oriental Medicine, Daejeon eClinical Trial Center, Soonchunhyang University Hospital, Cheonan, Korea.'}, {'ForeName': 'Goeun', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Miju', 'Initials': 'M', 'LastName': 'Son', 'Affiliation': ''}, {'ForeName': 'Youngeun', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Namhun', 'Initials': 'N', 'LastName': 'Heo', 'Affiliation': ''}, {'ForeName': 'Donghyo', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021183']
2464,32791693,"Effectiveness and safety of polydioxanone thread-embedding acupuncture (TEA) and electroacupuncture (EA) treatment for knee osteoarthritis (KOA) patients with postoperative pain: An assessor-blinded, randomized, controlled pilot trial.","BACKGROUND


Degenerative knee osteoarthritis (KOA) shows an increase in morbidity with improvement in the living conditions and extended lifespans. Treatment for degenerative KOA has been gaining attention since it significantly affects the life of the elderly population and is also associated with increased expenses for medical services and high socioeconomic costs. Treatments for degenerative KOA include nondrug therapy, drug therapy, and surgical treatment. For cases that show little response to conservative treatment but have not involved severe deformation of the knee, procedures such as arthroscopic surgery, autologous chondrocyte implantation, or autologous osteochondral transplantation can be performed. However, effective treatment is required for patients experiencing sustained knee pain after surgery. Although studies confirming the therapeutic effects of acupuncture or thread-embedding acupuncture (TEA) treatment for degenerative KOA have been reported, clinical studies on a combination of TEA and electroacupuncture (EA) in patients complaining of knee pain after arthroscopic surgery, autologous chondrocyte implantation, or autologous osteochondral transplantation have not yet been reported. Therefore, this study aimed to evaluate the effectiveness and safety of this combination treatment in patients with persistent knee pain after arthroscopic surgery, autologous chondrocyte implantation, or autologous osteochondral transplantation.
METHODS/DESIGN


This study has been designed as a 2-group, parallel, single-center, randomized, controlled, assessor-blinded trial. Thirty-six patients with degenerative KOA who complained of pain even after arthroscopic surgery, autologous chondrocyte implantation, or autologous osteochondral transplantation will be randomized to either the (TEA + EA + Usual care) group or the (Usual care only) group in a 1:1 ratio. The patients in the (TEA + EA + Usual care) group will receive TEA treatment once a week for 4 weeks for a total of 4 sessions and EA twice a week for a total of 8 sessions while continuing usual care. The (Usual care only) group will only receive usual care for 4 weeks. To assess the efficacy of the TEA and EA combination treatment, the visual analogue scale, the Korean version of the Western Ontario and McMaster Universities Osteoarthritis Index, the EuroQol 5-Dimension 5-Level, and the doses of the rescue drug taken will be evaluated at baseline (1W) and weeks 2 (2W), 4 (4W), 6 (6W), and 8 (8W). The primary efficacy endpoint is the mean change in visual analogue scale at week 4 (4W) compared to baseline. Adverse events will be assessed at every visit.
DISCUSSION


This study will provide useful data for evaluating the clinical efficacy and safety of TEA and electroacupuncture combination treatment for improving pain and quality of life after surgery for degenerative KOA.
TRIAL REGISTRATION


Clinical Research Information Service of Republic of Korea (CRIS- KCT0004804), March 6, 2020.",2020,"To assess the efficacy of the TEA and EA combination treatment, the visual analogue scale, the Korean version of the Western Ontario and McMaster Universities Osteoarthritis Index, the EuroQol 5-Dimension 5-Level, and the doses of the rescue drug taken will be evaluated at baseline (1W) and weeks 2 (2W), 4 (4W), 6 (6W), and 8 (8W).","['Degenerative knee osteoarthritis (KOA', 'knee osteoarthritis (KOA) patients with postoperative pain', 'patients complaining of knee pain after arthroscopic surgery, autologous chondrocyte implantation, or autologous osteochondral transplantation', 'patients with persistent knee pain after arthroscopic surgery, autologous chondrocyte implantation, or autologous osteochondral transplantation', 'Thirty-six patients with degenerative KOA who complained of pain even after arthroscopic surgery, autologous chondrocyte implantation, or autologous osteochondral transplantation']","['polydioxanone thread-embedding acupuncture (TEA) and electroacupuncture (EA', 'TEA', 'TEA and electroacupuncture (EA', 'acupuncture or thread-embedding acupuncture (TEA', 'TEA and electroacupuncture combination treatment', 'TEA\u200a+\u200aEA\u200a+\u200aUsual care']","['Adverse events', 'pain and quality of life', 'mean change in visual analogue scale', 'Effectiveness and safety', 'effectiveness and safety', 'visual analogue scale, the Korean version of the Western Ontario and McMaster Universities Osteoarthritis Index']","[{'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0750934', 'cui_str': 'Arthroscopy with surgical procedure'}, {'cui': 'C1446230', 'cui_str': 'Autologous chondrocyte implantation'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0476169', 'cui_str': 'Osteochondral fracture'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0085242', 'cui_str': 'Polydioxanone'}, {'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}]",36.0,0.0890456,"To assess the efficacy of the TEA and EA combination treatment, the visual analogue scale, the Korean version of the Western Ontario and McMaster Universities Osteoarthritis Index, the EuroQol 5-Dimension 5-Level, and the doses of the rescue drug taken will be evaluated at baseline (1W) and weeks 2 (2W), 4 (4W), 6 (6W), and 8 (8W).","[{'ForeName': 'Ye Ji', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'aDepartment of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Daejeon University bClinical Medicine Division, Korea Institute of Oriental Medicine cKorean Medicine Life Science, University of Science and Technology (UST), Campus of Korea Institute of Oriental Medicine, Daejeon dDepartment of Clinical Korean Medicine, Graduate School, Kyung Hee University, Seoul eDepartment of Korean Medicine Rehabilitation, College of Korean Medicine, Daejeon University, Daejeon, Republic of Korea.'}, {'ForeName': 'Chang-Hyun', 'Initials': 'CH', 'LastName': 'Han', 'Affiliation': ''}, {'ForeName': 'Ju Hyun', 'Initials': 'JH', 'LastName': 'Jeon', 'Affiliation': ''}, {'ForeName': 'Eunseok', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Jin Youp', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Ki Hyun', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Ae Ran', 'Initials': 'AR', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Eun Jung', 'Initials': 'EJ', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Young Il', 'Initials': 'YI', 'LastName': 'Kim', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021184']
2465,31976867,Morphine and Cardiovascular Outcomes Among Patients With Non-ST-Segment Elevation Acute Coronary Syndromes Undergoing Coronary Angiography.,"BACKGROUND


Mechanistic studies have shown that morphine blunts the antiplatelet effects of oral adenosine diphosphate receptor blockers. However, the clinical relevance of this interaction is controversial.
OBJECTIVES


This study sought to explore the association between morphine and ischemic events in 5,438 patients treated with concomitant clopidogrel presenting with non-ST-segment elevation acute coronary syndromes (NSTEACS) in the EARLY ACS (Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome) trial. Patients not treated with clopidogrel (n = 3,462) were used as negative controls.
METHODS


Endpoints were the composite of death, myocardial infarction (MI), recurrent ischemia, or thrombotic bailout at 96 h (4-way endpoint) and the composite of death or MI at 30 days.
RESULTS


In patients treated with clopidogrel, morphine use was associated with higher rates of the 4-way endpoint at 96 h (adjusted odds ratio [OR]: 1.40; 95% confidence interval [CI]: 1.04 to 1.87; p = 0.026). There was a trend for higher rates of death or MI at 30 days (adjusted OR: 1.29; 95% CI: 0.98 to 1.70; p = 0.072), driven by events in the first 48 h (adjusted hazard ratio: 1.54; 95% CI: 1.07 to 2.23; p = 0.021). In patients not treated with clopidogrel, morphine was not associated with either the 4-way endpoint at 96 h (adjusted OR: 1.05; 95% CI: 0.74 to 1.49; p = 0.79; p interaction  = 0.36 ) or death or MI at 30 days (adjusted OR: 1.07; 95% CI: 0.77 to 1.48; p = 0.70; p interaction  = 0.46).
CONCLUSIONS


When used concomitantly with clopidogrel pre-treatment, morphine was associated with higher rates of ischemic events in patients with NSTEACS. (EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome; NCT00089895).",2020,"There was a trend for higher rates of death or MI at 30 days (adjusted OR: 1.29; 95% CI: 0.98 to 1.70; p = 0.072), driven by events in the first 48 h (adjusted hazard ratio: 1.54; 95% CI: 1.07 to 2.23; p = 0.021).","['5,438 patients treated with concomitant clopidogrel presenting with non-ST-segment elevation acute coronary syndromes (NSTEACS) in the EARLY ACS (Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome) trial', 'Patients With Non-ST-Segment Elevation Acute Coronary Syndrome', 'patients with NSTEACS', 'Non-ST-Segment Elevation Acute Coronary Syndromes Undergoing Coronary Angiography', 'Patients With']","['Morphine', 'clopidogrel, morphine', 'clopidogrel', 'morphine']","['death or MI', 'higher rates of death or MI', 'composite of death, myocardial infarction (MI), recurrent ischemia, or thrombotic bailout at 96 h (4-way endpoint) and the composite of death or MI at 30\xa0days', 'ischemic events', 'Cardiovascular Outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3160886', 'cui_str': 'Non ST segment elevation acute coronary syndrome'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0016011', 'cui_str': 'Glycoproteins IIb-IIIa'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0336968', 'cui_str': 'Sky-diving'}, {'cui': 'C1813909', 'cui_str': '4-Way'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",3462.0,0.0999155,"There was a trend for higher rates of death or MI at 30 days (adjusted OR: 1.29; 95% CI: 0.98 to 1.70; p = 0.072), driven by events in the first 48 h (adjusted hazard ratio: 1.54; 95% CI: 1.07 to 2.23; p = 0.021).","[{'ForeName': 'Remo H M', 'Initials': 'RHM', 'LastName': 'Furtado', 'Affiliation': ""Thrombosis In Myocardial Infarction Study Group-Brigham and Women's Hospital, Boston, Massachusetts; Instituto do Coracao (InCor), Hospital das Clinicas da Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.""}, {'ForeName': 'José C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clinicas da Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ""Thrombosis In Myocardial Infarction Study Group-Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Kyungah', 'Initials': 'K', 'LastName': 'Im', 'Affiliation': ""Thrombosis In Myocardial Infarction Study Group-Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'White', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""Thrombosis In Myocardial Infarction Study Group-Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'L Kristin', 'Initials': 'LK', 'LastName': 'Newby', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""Thrombosis In Myocardial Infarction Study Group-Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: rgiugliano@bwh.harvard.edu.""}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.11.035']
2466,30861160,Comparison of the Pharmacokinetic Properties of Naloxone Following the Use of FDA-Approved Intranasal and Intramuscular Devices Versus a Common Improvised Nasal Naloxone Device.,"For more than a decade, first responders and the general public have been able to treat suspected opioid overdoses using an improvised nasal naloxone device (INND) constructed from a prefilled syringe containing 2 mg of naloxone (1 mg/mL) attached to a mucosal atomization device. In recent years, the U.S. Food and Drug Administration (FDA)-approved Ezvio, an autoinjector that delivers 2 mg by intramuscular injection and Narcan nasal spray (2- and 4-mg strengths; 0.1 mL/dose) for the emergency treatment of a known or suspected opioid overdose. The present study was conducted to compare the pharmacokinetics of naloxone using the FDA-approved devices (each administered once) and either 1 or 2 administrations using the INND. When naloxone was administered twice using the improvised device, the doses were separated by 2 minutes. The highest maximum plasma concentration was achieved using the 4-mg FDA-approved spray. The highest exposures at 5 minutes postdose, based on AUC values, were after administration with the autoinjector and the 4-mg FDA-approved spray; at 10, 15, and 20 minutes postdose, the latter yielded the greatest exposure. Even after 2 administrations, the INND failed to achieve naloxone plasma levels comparable to the FDA-approved devices at any time. The ease of use and higher plasma concentrations achieved using the 4-mg FDA-approved spray, compared with the INND, should be considered when deciding which naloxone device to use.",2019,"Even after 2 administrations, the INND failed to achieve naloxone plasma levels comparable to the FDA-approved devices at any time.",[],"['Narcan nasal spray ', 'naloxone', 'Naloxone', 'FDA-Approved Intranasal and Intramuscular Devices']","['highest maximum plasma concentration', 'naloxone plasma levels']",[],"[{'cui': 'C0684237', 'cui_str': 'Narcanti'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0352292,"Even after 2 administrations, the INND failed to achieve naloxone plasma levels comparable to the FDA-approved devices at any time.","[{'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Krieter', 'Affiliation': 'National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'C Nora', 'Initials': 'CN', 'LastName': 'Chiang', 'Affiliation': 'National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Shwe', 'Initials': 'S', 'LastName': 'Gyaw', 'Affiliation': 'National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'McCann', 'Affiliation': 'National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1401']
2467,30937964,Evaluation of cord blood immunoglobulin E and its association with maternal factors in a group of Iranian newborns.,"Allergic disorders are among the most common diseases around the world especially in children. Many factors contribute to the pathogenesis of atopic disorders, but early events during the pregnancy are very important. The aim of this study was to evaluate the level of cord blood immunoglobulin E (CB-IgE) and its association with maternal in a group of Iranian newborns. In a cross-sectional study, 163 pregnant women randomly selected and information about pregnancy and atopy were taken by questionnaire. Blood samples of mothers and matched cord blood were collected and total serum IgE levels were measured by enzyme-linked immunosorbent assay (ELISA) method. To rolling out the possibility of contamination with maternal blood, total IgA was checked for all the cord blood samples. Sixteen percent of mothers had the history of atopic diseases and the mean IgE level was significantly higher in an atopic than nonatopic mothers (241 vs 102, P < 0.001). About 73.9% of cord blood samples, had high IgE level (>0.9 IU/mL). The level of cord blood IgE (CB-IgE) was not significantly different in male and female newborns (2.14 vs 2.15 IU/mL). There was no significant correlation between maternal factors such as age, pregnancy variables, allergens exposure, smoking, and maternal IgE with cord blood IgE. The results of this study showed that CB-IgE is high in a remarkable number of samples; independent of maternal or fetal factors. Further studies need to evaluate the reasons for the high level of IgE in cord blood in our area.",2019,"About 73.9% of cord blood samples, had high IgE level (>0.9 IU/mL).","['163 pregnant women randomly selected and information about pregnancy and atopy were taken by questionnaire', 'Iranian newborns', 'group of Iranian newborns']",[],"['level of cord blood IgE (CB-IgE', 'history of atopic diseases', 'mean IgE level', 'maternal factors such as age, pregnancy variables, allergens exposure, smoking, and maternal IgE with cord blood IgE', 'high IgE level', 'total serum IgE levels', 'level of cord blood immunoglobulin E (CB-IgE']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0392707', 'cui_str': 'Atopy'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0392707', 'cui_str': 'Atopy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",163.0,0.030674,"About 73.9% of cord blood samples, had high IgE level (>0.9 IU/mL).","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Fereidouni', 'Affiliation': 'Cellular and Molecular Research Center, Medical School, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Fateme Arefe', 'Initials': 'FA', 'LastName': 'Nami', 'Affiliation': 'Asthma, Allergy & Immunology Research Center, Medical School, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Serki', 'Affiliation': 'Asthma, Allergy & Immunology Research Center, Medical School, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Arefi', 'Affiliation': 'Institute of Genetics Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom.'}]",Journal of cellular biochemistry,['10.1002/jcb.28639']
2468,30997816,The Effect of Hormonal Contraception on Cervicovaginal Mucosal End Points Associated with HIV Acquisition.,"Reproductive age women may choose to concurrently use topical antiretrovirals and hormonal contraceptives (HCs) to simultaneously prevent HIV-1 infection and unintended/mistimed pregnancy. There are conflicting data on the effect of HCs on mucosal susceptibility to HIV-1. The objective of this study was to evaluate cervicovaginal (CV) mucosal data from healthy women before and after initiation of either oral contraceptive pills (OCPs) or depot medroxyprogesterone acetate (DMPA) injection. CONRAD A10-114 was a prospective, open-label, parallel cohort study. We enrolled 74 women and 62 completed the visits (32 and 30 who selected OCPs and DMPA, respectively). Participants provided CV lavage, vaginal biopsies, and CV swabs at baseline in the luteal phase and then ∼6 weeks after initiating HCs. After contraceptive initiation, there were significant increases in vaginal immune cell density among both DMPA and OCP users. Changes for OCP users were concentrated in the subepithelial lamina propria, whereas for DMPA users, they were distributed throughout the vaginal tissue, including the epithelium (CD45 + , CD3 + , CD4 + , and CD1a + ). Contraceptive use altered concentrations of soluble CV inflammatory and immune mediators, with significant reductions in some proinflammatory cytokines and secretory leukoprotease inhibitor. Compared with baseline, p24 antigen production after  ex vivo  HIV-1 infection of vaginal biopsies doubled after DMPA use, but all  p -values were >.05. HIV-1 replication was significantly higher in DMPA-exposed tissues compared with those from the OCP group at the end of the tissue culture ( p  = .01). Although not statistically significant, median  in vitro  inhibition of HIV-1 by CV fluid (innate antiviral activity), was reduced by ∼50% with HCs ( p  > .21). Exposure to exogenous contraceptive hormones significantly increased vaginal immune cells and reduced CV proinflammatory cytokines and antimicrobial peptides. DMPA users showed higher susceptibility to HIV-1  ex vivo  infection.",2019,"Although not statistically significant, median  in vitro  inhibition of HIV-1 by CV fluid (innate antiviral activity), was reduced by ∼50% with HCs ( p  > .21).","['healthy women before and after initiation of either', 'Reproductive age women', 'We enrolled 74 women and 62 completed the visits (32 and 30 who selected OCPs and DMPA, respectively']","['Hormonal Contraception', 'oral contraceptive pills (OCPs) or depot medroxyprogesterone acetate (DMPA) injection', 'DMPA', 'topical antiretrovirals and hormonal contraceptives (HCs', 'OCP']","['CV lavage, vaginal biopsies, and CV swabs', 'cervicovaginal (CV) mucosal data', 'median  in vitro  inhibition of HIV-1 by CV fluid (innate antiviral activity', 'vaginal immune cell density', 'Cervicovaginal Mucosal End Points', 'replication', 'vaginal immune cells and reduced CV proinflammatory cytokines and antimicrobial peptides', 'HIV-1', 'infection of vaginal biopsies']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}]","[{'cui': 'C2985296', 'cui_str': 'Hormonal contraception'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C1282359', 'cui_str': 'Ocular cicatricial pemphigoid'}]","[{'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0195133', 'cui_str': 'Vaginal biopsy'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0162339', 'cui_str': 'Cell Density'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0598312', 'cui_str': 'DNA replication'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",74.0,0.204027,"Although not statistically significant, median  in vitro  inhibition of HIV-1 by CV fluid (innate antiviral activity), was reduced by ∼50% with HCs ( p  > .21).","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Thurman', 'Affiliation': 'Eastern Virginia Medical School, CONRAD, Norfolk, Virginia.'}, {'ForeName': 'Neelima', 'Initials': 'N', 'LastName': 'Chandra', 'Affiliation': 'Eastern Virginia Medical School, CONRAD, Norfolk, Virginia.'}, {'ForeName': 'Jill L', 'Initials': 'JL', 'LastName': 'Schwartz', 'Affiliation': 'Eastern Virginia Medical School, CONRAD, Norfolk, Virginia.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Brache', 'Affiliation': 'Profamilia, Santo Domingo, Dominican Republic.'}, {'ForeName': 'Beatrice A', 'Initials': 'BA', 'LastName': 'Chen', 'Affiliation': 'Magee-Womens Research Institute, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Asin', 'Affiliation': 'V.A. Medical Center, White River Junction, VT and Geisel School of Medicine, Dartmouth, New Hampshire.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Rollenhagen', 'Affiliation': 'V.A. Medical Center, White River Junction, VT and Geisel School of Medicine, Dartmouth, New Hampshire.'}, {'ForeName': 'Betsy C', 'Initials': 'BC', 'LastName': 'Herold', 'Affiliation': 'Department of Pediatric Infectious Diseases, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Raina N', 'Initials': 'RN', 'LastName': 'Fichorova', 'Affiliation': ""Laboratory of Genital Tract Biology, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Hillier', 'Affiliation': 'Magee-Womens Research Institute, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Debra H', 'Initials': 'DH', 'LastName': 'Weiner', 'Affiliation': 'FHI 360, Durham, North Carolina.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Mauck', 'Affiliation': 'Eastern Virginia Medical School, CONRAD, Norfolk, Virginia.'}, {'ForeName': 'Gustavo F', 'Initials': 'GF', 'LastName': 'Doncel', 'Affiliation': 'Eastern Virginia Medical School, CONRAD, Norfolk, Virginia.'}]",AIDS research and human retroviruses,['10.1089/AID.2018.0298']
2469,32792737,Efficacy of ultrasound guided quadratus lumborum block as postoperative analgesia in renal transplantation recipients: A randomised double blind clinical study.,"Background and Aims


Postoperative pain following renal transplantation is moderate to severe. Quadratus lumborum block (QLB) is a new block that can provide effective analgesia following abdominal and retroperitoneal surgeries. This study aimed to evaluate the analgesic efficacy of QLB for postoperative analgesia in patients undergoing renal transplantation.
Methods


Patients were randomised into two groups of 30 each. In group A (block group), 20 mL of 0.25% bupivacaine and group B (placebo group), 20 mLof normal saline were injected. In the postoperative room, an intravenous patient controlled analgesia (IVPCA) pump with fentanyl was started in both the group. The postoperatively recorded parameters were numerical rating scale (NRS) pain score at rest and on movement and coughing, total fentanyl consumption, sedation score, postoperative nausea vomiting, limb weakness, paralytic ileus, and any other block-related complication. Data were analysed using SPSS software version 22.0. Categorical data were analysed using the Chi-square method. Student t test or Mann-Whitney U test was applied for the continuous data. Numerical data with normal distribution were displayed as mean (standard deviation), abnormal distribution was displayed in the median (interquartile range) values, and as a percentage for categorical variables.
Results


Fentanyl consumption, numerical rating score, and sedation score were significantly less in group A when compared to group B at 1, 4, 8, 12, and 24 h ( P  < 0.001).
Conclusion


Type-1 QLB significantly reduces fentanyl consumption and NRS pain score at 1,4,8,12, and 24 h in the postoperative period in renal transplant recipients.",2020,"Results


Fentanyl consumption, numerical rating score, and sedation score were significantly less in group A when compared to group B at 1, 4, 8, 12, and 24 h ( P  < 0.001).
","['renal transplantation recipients', 'renal transplant recipients', 'patients undergoing renal transplantation']","['QLB', 'Quadratus lumborum block (QLB', 'bupivacaine and group B (placebo', 'intravenous patient controlled analgesia (IVPCA) pump with fentanyl', 'ultrasound guided quadratus lumborum block']","['analgesic efficacy', 'fentanyl consumption and NRS pain score', 'Fentanyl consumption, numerical rating score, and sedation score', 'numerical rating scale (NRS) pain score at rest and on movement and coughing, total fentanyl consumption, sedation score, postoperative nausea vomiting, limb weakness, paralytic ileus, and any other block-related complication']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0587246', 'cui_str': 'Muscle weakness of limb'}, {'cui': 'C0030446', 'cui_str': 'Paralytic ileus'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.173631,"Results


Fentanyl consumption, numerical rating score, and sedation score were significantly less in group A when compared to group B at 1, 4, 8, 12, and 24 h ( P  < 0.001).
","[{'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Sindwani', 'Affiliation': 'Department of Anaesthesiology, ILBS, New Delhi, India.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Sahu', 'Affiliation': 'Department of Anaesthesiology, SGPGIMS, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Suri', 'Affiliation': 'Department of Oncoanesthesia, AIIMS, New Delhi, India.'}, {'ForeName': 'Sanjoy', 'Initials': 'S', 'LastName': 'Sureka', 'Affiliation': 'Department of Urology and Renal Transplantation, SGPGIMS, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Department of Anaesthesiology, ILBS, New Delhi, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_21_20']
2470,32792739,"A prospective randomised trial to compare three insertion techniques for i-gel™ placement: Standard, reverse, and rotation.","Background and Aims


This prospective randomised study was done to compare standard, reverse, and rotation techniques of i-gel™ placement in terms of insertion characteristics and success rate.
Material and Methods


After institutional ethics committee approval, 135 patients aged 18-50 years, ASA I and II undergoing elective surgery under general anesthesia were included. After induction of anesthesia, i-gel™ was inserted by standard, reverse, and rotation technique in Groups I, II, and III, respectively. The primary objective was mean time of insertion. Secondary variables included ease of insertion, first attempt success rate, manoeuvres required, fiberoptic view of placement, oropharyngeal leak pressure, ease of placement of nasogastric tube, and complications if any.
Results


Mean time of insertion was 18.04 ± 5.65 s, 15.00 ± 5.72 s and 16.12 ± 5.84 s for groups I, II, and III, respectively. Time taken for insertion was shortest and significantly lower ( P  = 0.048) for group II compared to group I. Insertion time was comparable between rest of groups. The overall success rate in groups I, II, and III were 91.1%, 95.6%, and 93.3% respectively ( P  = 0.7). The first attempt success rate was 82.2%, 89%, and 84.4% in groups I, II and III, respectively ( P  = 0.07). Manoeuvres were required in five (12.19%) patients in group I, four (9.30%) patients in group II, and three (7.14%) patients in group III ( P  = 0.602). Complications occurred in eight, three, and three patients in groups I, II, and III, respectively.
Conclusion


All techniques of i-gel insertion are equally good and choice of technique depends upon the experience and comfort of the investigator with the particular technique.",2020,Time taken for insertion was shortest and significantly lower ( P  = 0.048) for group II compared to group I. Insertion time was comparable between rest of groups.,"['135 patients aged 18-50 years, ASA I and II undergoing elective surgery under general anesthesia were included']",[],"['Time taken for insertion', 'overall success rate', 'ease of insertion, first attempt success rate, manoeuvres required, fiberoptic view of placement, oropharyngeal leak pressure, ease of placement of nasogastric tube, and complications if any', 'Complications', 'Mean time of insertion', 'success rate', 'mean time of insertion']","[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",135.0,0.0240024,Time taken for insertion was shortest and significantly lower ( P  = 0.048) for group II compared to group I. Insertion time was comparable between rest of groups.,"[{'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Bhardwaj', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Pt. BD Sharma University of Health Sciences, Rohtak, Haryana, India.'}, {'ForeName': 'Suresh K', 'Initials': 'SK', 'LastName': 'Singhal', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Pt. BD Sharma University of Health Sciences, Rohtak, Haryana, India.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Rashmi', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Pt. BD Sharma University of Health Sciences, Rohtak, Haryana, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Dahiya', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Pt. BD Sharma University of Health Sciences, Rohtak, Haryana, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_937_19']
2471,32792757,Effectiveness of Misoprostol in Office Hysteroscopy in Premenopausal Nulliparous Women: A Prospective Randomized Double-Blind Placebo-Controlled Trial.,"Study Objective


The objective of this was to evaluate the effectiveness of misoprostol in premenopausal nulliparous women with 200-mcg single vaginal dose 4 h before the procedure.
Design


This was a prospective randomized double-blind placebo-controlled trial.
Setting


This study was conducted in a tertiary care and academic research center.
Patients


One hundred patients were included in the study: 50 in misoprostol group and 50 in placebo.
Interventions


Patients underwent office hysteroscopy 4 h after vaginal application of misoprostol or placebo.
Measurements and Main Results


Ease of doing hysteroscopy was significantly better in the misoprostol group (difficulty score: 2.74 ± 1.20) as compared to placebo (difficulty score: 4.20 ± 1.10),  P  = 0.001. The time taken for negotiating the internal os (cervical passage time) was found to be significantly shorter in the misoprostol group (6.20 ± 5.21 s) as compared to placebo (14.78 ± 11.84 s),  P  = 0.001. The overall Visual Analog Scale (VAS) score was significantly lower in the intervention group (2.64 ± 1.62) as compared to placebo (4.90 ± 1.90),  P  = 0.001. Moreover, the VAS score at the point of passing internal os was significantly lower in the misoprostol group (2.82 ± 1.39) as compared to placebo (4.94 ± 1.96),  P  = 0.001. Misoprostol had a significant positive effect on satisfaction level of patients; 76% ( n  = 38) of women in the misoprostol group expressed their willingness to undergo the procedure again if required versus 18% ( n  = 9) in placebo,  P  = 0.001. Furthermore, 78% ( n  = 39) of women in the misoprostol group would recommend the procedure to their friends and relatives versus 36% ( n  = 18) in placebo,  P  = 0.001.
Conclusion


Preoperative cervical preparation with 200 mcg of misoprostol vaginal application 4 h before office hysteroscopy in premenopausal nulliparous women significantly reduces the difficulty encountered in negotiating the cervical canal. Further, it significantly reduces the pain experienced by the patient at the point of passage through internal os as well as throughout the entire procedure.",2020,"Misoprostol had a significant positive effect on satisfaction level of patients; 76% ( n  = 38) of women in the misoprostol group expressed their willingness to undergo the procedure again if required versus 18% ( n  = 9) in placebo,  P  = 0.001.","['premenopausal nulliparous women with 200-mcg single vaginal dose 4 h before the procedure', 'Patients', 'One hundred patients were included in the study: 50 in misoprostol group and 50 in', 'premenopausal nulliparous women', 'Premenopausal Nulliparous Women']","['Placebo', 'Misoprostol', 'misoprostol vaginal application', 'misoprostol or placebo', 'misoprostol', 'placebo']","['VAS score', 'overall Visual Analog Scale (VAS) score', 'satisfaction level', 'time taken for negotiating the internal os (cervical passage time', 'pain', 'Measurements and Main Results\n\n\nEase of doing hysteroscopy']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0227842', 'cui_str': 'Structure of internal os'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}]",100.0,0.57831,"Misoprostol had a significant positive effect on satisfaction level of patients; 76% ( n  = 38) of women in the misoprostol group expressed their willingness to undergo the procedure again if required versus 18% ( n  = 9) in placebo,  P  = 0.001.","[{'ForeName': 'Vinod G', 'Initials': 'VG', 'LastName': 'Nair', 'Affiliation': 'Department of Obstetrics and Gynaecology, Division of Minimally Invasive Gynaecological Surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Kallol Kumar', 'Initials': 'KK', 'LastName': 'Roy', 'Affiliation': 'Department of Obstetrics and Gynaecology, Division of Minimally Invasive Gynaecological Surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rakhi', 'Initials': 'R', 'LastName': 'Rai', 'Affiliation': 'Department of Obstetrics and Gynaecology, Division of Minimally Invasive Gynaecological Surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Anamika', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Department of Obstetrics and Gynaecology, Division of Minimally Invasive Gynaecological Surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Juhi', 'Initials': 'J', 'LastName': 'Bharti', 'Affiliation': 'Department of Obstetrics and Gynaecology, Division of Minimally Invasive Gynaecological Surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rinchen', 'Initials': 'R', 'LastName': 'Zangmo', 'Affiliation': 'Department of Obstetrics and Gynaecology, Division of Minimally Invasive Gynaecological Surgery, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of human reproductive sciences,['10.4103/jhrs.JHRS_149_19']
2472,32792761,A Comparative Study of the Efficacy of Levosulpiride versus Paroxetine in Premature Ejaculation.,"Background


Premature ejaculation (PME) can be defined as a lack in the normal voluntary control over ejaculation. It is the most common sexual dysfunction encountered by the male populace. In general, these patients presents with distress. Hence, a novel treatment to eliminate their problem is required. Although the role of SSRI has already been established, the high discontinuation rate and other types of sexual dysfunctions associated with SSRIs reduce their efficacy in controlling this menace. Levosulpiride is a new drug indicated in treatment of PE.
Aims and Objectives


The objective is to study the efficacy of levosulpiride; paroxetine and their comparison in patients of PE.
Methodology


Index of premature ejaculation (IPE) and intravaginal ejaculation latency time (IELT) were used. A total of 36 patients (18 in each group) were included. The patients were assessed at baseline; at 4 weeks' and at 8 weeks' interval.
Results


On comparison the score of IPE in domains of ejaculation control, sexual satisfaction, and the total score of IPE were statistically significant on all the three visits. However, the distress score of IPE and the IELT score were statistically not significant between the two groups.
Conclusion


No doubt both agents are efficacious in patients of PME but paroxetine is more efficacious than levosulpiride. At the same time, levosulpiride is a lesser studied and used drug hence more research should be done for it.",2020,No doubt both agents are efficacious in patients of PME but paroxetine is more efficacious than levosulpiride.,"['36 patients (18 in each group) were included', 'Premature Ejaculation', 'patients of PE.\nMethodology\n\n\nIndex of premature ejaculation (IPE) and']","['Paroxetine', 'levosulpiride; paroxetine', 'paroxetine', 'Levosulpiride', 'levosulpiride', '\n\n\nPremature ejaculation (PME']","['intravaginal ejaculation latency time (IELT', 'score of IPE in domains of ejaculation control, sexual satisfaction, and the total score of IPE', 'distress score of IPE and the IELT score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0070122', 'cui_str': 'Paroxetine'}, {'cui': 'C0210380', 'cui_str': 'levosulpiride'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}]","[{'cui': 'C0442122', 'cui_str': 'Intravaginal'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871356', 'cui_str': 'Sexual Gratification'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",36.0,0.0341408,No doubt both agents are efficacious in patients of PME but paroxetine is more efficacious than levosulpiride.,"[{'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Bathla', 'Affiliation': 'Department of Psychiatry, Maharishi Markandeshwar Institute of Medical Sciences and Research, MMDU, Mullana, Haryana, India.'}, {'ForeName': 'Shazia', 'Initials': 'S', 'LastName': 'Anjum', 'Affiliation': 'Department of Psychiatry, Maharishi Markandeshwar Institute of Medical Sciences and Research, MMDU, Mullana, Haryana, India.'}, {'ForeName': 'Angad Harshbir', 'Initials': 'AH', 'LastName': 'Singh', 'Affiliation': 'Department of Psychiatry, Maharishi Markandeshwar Institute of Medical Sciences and Research, MMDU, Mullana, Haryana, India.'}, {'ForeName': 'Vinutha', 'Initials': 'V', 'LastName': 'Ramesh', 'Affiliation': 'Department of Psychiatry, Maharishi Markandeshwar Institute of Medical Sciences and Research, MMDU, Mullana, Haryana, India.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Department of Psychiatry, Maharishi Markandeshwar Institute of Medical Sciences and Research, MMDU, Mullana, Haryana, India.'}, {'ForeName': 'Leezu', 'Initials': 'L', 'LastName': 'Bhusri', 'Affiliation': 'Department of Psychiatry, Maharishi Markandeshwar Institute of Medical Sciences and Research, MMDU, Mullana, Haryana, India.'}]",Journal of human reproductive sciences,['10.4103/jhrs.JHRS_155_19']
2473,32792900,The Effect of Music Intervention on Attention in Children: Experimental Evidence.,"Although music has been utilized as a therapeutic tool for children with cognitive impairments, how it improves children's cognitive function remains poorly understood. As a first step toward understanding music's effectiveness and as a means of assessing cognitive function improvement, we focused on attention, which plays an important role in cognitive development, and examined the effect of a music intervention on children's attention. Thirty-five children, aged 6 to 9 years, participated in this study, with data from 29 of the children being included in the analysis. A single 30-minute interactive music intervention was compared with a single 30-minute interactive video game intervention accompanied by computer-generated background music using a within-subjects repeated-measures design. Each intervention was implemented individually. Participants completed a standardized attention assessment, the Test of Everyday Attention for Children, before and after both interventions to assess changes in their attentional skills. The results indicated significant improvement in attention control/switching following the music intervention after controlling for the children's intellectual abilities, while no such changes were observed following the video game intervention. This study provides the first evidence that music interventions may be more effective than video game interventions to improve attention control in children, and furthers our understanding of the importance of music interventions for children with attention control problems.",2020,"The results indicated significant improvement in attention control/switching following the music intervention after controlling for the children's intellectual abilities, while no such changes were observed following the video game intervention.","['children with cognitive impairments', 'Thirty-five children, aged 6 to 9 years, participated in this study, with data from 29 of the children being included in the analysis', 'children with attention control problems', 'Children', ""children's attention""]","['Music Intervention', 'music intervention']",['attention control/switching'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",35.0,0.0642069,"The results indicated significant improvement in attention control/switching following the music intervention after controlling for the children's intellectual abilities, while no such changes were observed following the video game intervention.","[{'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Kasuya-Ueba', 'Affiliation': 'Department of Human Health Science, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'Institute of Psychology, Shenzhen Key Laboratory of Affective and Social Neuroscience, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Motomi', 'Initials': 'M', 'LastName': 'Toichi', 'Affiliation': 'Department of Human Health Science, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}]",Frontiers in neuroscience,['10.3389/fnins.2020.00757']
2474,32792957,Phosphodiesterase 4 Inhibitors in Allergic Rhinitis/Rhinosinusitis.,"Allergic rhinitis/rhinosinusitis (AR) is the most common allergic disease. It affects patients' quality of life and may influence the severity of lower airway disease such as asthma. Therefore, its treatment is of great importance. AR is treated by a combination of effective approaches; however, in some patients, the disease is uncontrolled. In the last several years, the concept of AR has shifted from increased T helper 2 (Th2) cell signaling and downstream inflammation to disease phenotypes with non-Th2-mediated inflammation. AR is a largely heterogenous group of airway diseases, and as such, research should not only focus on immunosuppressive agents (e.g., corticosteroids) but should also include targeted immunomodulatory pathways. Here, we provide an overview of novel therapies, focusing on the role of phosphodiesterase-4 (PDE4) inhibitors in AR. PDE4 inhibitors are potent anti-inflammatory agents that are used for the treatment of inflammatory airway diseases including AR. The PDE4 inhibitor roflumilast was shown to effectively control symptoms of AR in a randomized, placebo-controlled, double-blinded, crossover study in patients with a history of AR. However, only a few PDE4 inhibitors have proceeded to phase II and III clinical trials, due to insufficient clinical efficacy and adverse effects. Research is ongoing to develop more effective compounds with fewer side effects that target specific inflammatory pathways in disease pathogenesis and can provide more consistent benefit to patients with upper airway allergic diseases. Novel specific PDE4 inhibitors seem to fulfill these criteria.",2020,"In the last several years, the concept of AR has shifted from increased T helper 2 (Th2) cell signaling and downstream inflammation to disease phenotypes with non-Th2-mediated inflammation.","['patients with upper airway allergic diseases', 'Allergic Rhinitis/Rhinosinusitis', 'Allergic rhinitis/rhinosinusitis (AR', 'patients with a history of AR']","['Phosphodiesterase 4 Inhibitors', 'phosphodiesterase-4 (PDE4) inhibitors', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C2936609', 'cui_str': 'Phosphodiesterase 4 inhibitor'}, {'cui': 'C0070829', 'cui_str': 'Type 4 Cyclic Nucleotide Phosphodiesterase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0151292,"In the last several years, the concept of AR has shifted from increased T helper 2 (Th2) cell signaling and downstream inflammation to disease phenotypes with non-Th2-mediated inflammation.","[{'ForeName': 'Viera', 'Initials': 'V', 'LastName': 'Janosova', 'Affiliation': 'Clinic of Otorhinolaryngology and Head and Neck Surgery, Jessenius Faculty of Medicine, Comenius University in Bratislava, and Martin University Hospital, Martin, Slovakia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Calkovsky', 'Affiliation': 'Clinic of Otorhinolaryngology and Head and Neck Surgery, Jessenius Faculty of Medicine, Comenius University in Bratislava, and Martin University Hospital, Martin, Slovakia.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Pedan', 'Affiliation': 'Clinic of Otorhinolaryngology and Head and Neck Surgery, Jessenius Faculty of Medicine, Comenius University in Bratislava, and Martin University Hospital, Martin, Slovakia.'}, {'ForeName': 'Estera', 'Initials': 'E', 'LastName': 'Behanova', 'Affiliation': 'Clinic of Otorhinolaryngology and Head and Neck Surgery, Jessenius Faculty of Medicine, Comenius University in Bratislava, and Martin University Hospital, Martin, Slovakia.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Hajtman', 'Affiliation': 'Clinic of Otorhinolaryngology and Head and Neck Surgery, Jessenius Faculty of Medicine, Comenius University in Bratislava, and Martin University Hospital, Martin, Slovakia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Calkovska', 'Affiliation': 'Department of Physiology, Jessenius Faculty of Medicine, Comenius University in Bratislava, Martin, Slovakia.'}]",Frontiers in pharmacology,['10.3389/fphar.2020.01135']
2475,32793007,A Group-Based Community Reinforcement Approach of Cognitive Behavioral Therapy Program to Improve Self-Care Behavior of Patients With Type 2 Diabetes.,"Introduction


This study evaluated a cognitive behavioral-based self-care intervention program on diabetes management in individuals with type 2 diabetes in Jiangsu Province, China. People with type 2 diabetes were recruited to a 6-month, prospective, intervention study.
Methods


The intervention group (n = 296) received an intensive cognitive behavioral-based self-care intervention, including group activities, frequent blood glucose monitoring, nutritional counseling, diabetes-specific meal and a weekly progress report. The control group (n = 110) received diabetes education, including diet and physical activity instruction only. Assessment data was obtained at baseline, and after 12 and/or 24 weeks of intervention. The intention to treat method was used to assess the effectiveness of the intervention program.
Results


The intervention group showed improved fasting blood glucose, HbA1c, systolic and diastolic blood pressures compared to the control group. The intervention group also had significantly improved knowledge and self-care behavior, and general health.
Conclusion


This study demonstrates that significant improvement in glycemic control and markers of cardiovascular health can occur in Chinese people with type 2 diabetes following a CBT-based intervention program that includes diabetes education, frequent blood glucose monitoring and daily use of a diabetes-specific meal plan, suggesting CBT is beneficial to improve health outcome in patients with type 2 diabetes.",2020,"The intervention group showed improved fasting blood glucose, HbA1c, systolic and diastolic blood pressures compared to the control group.","['People with type 2 diabetes', 'Chinese people with type 2 diabetes', 'Patients', 'patients with type 2 diabetes', 'individuals with type 2 diabetes in Jiangsu Province, China']","['Cognitive Behavioral Therapy Program', 'cognitive behavioral-based self-care intervention program', 'diabetes education, including diet and physical activity instruction only', 'intensive cognitive behavioral-based self-care intervention, including group activities, frequent blood glucose monitoring, nutritional counseling, diabetes-specific meal and a weekly progress report']","['knowledge and self-care behavior, and general health', 'Self-Care Behavior', 'glycemic control and markers of cardiovascular health', 'fasting blood glucose, HbA1c, systolic and diastolic blood pressures']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0242586', 'cui_str': 'Progress report'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",,0.012964,"The intervention group showed improved fasting blood glucose, HbA1c, systolic and diastolic blood pressures compared to the control group.","[{'ForeName': 'Xiaoqun', 'Initials': 'X', 'LastName': 'Pan', 'Affiliation': 'Jiangsu Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Zhen Jiang Center for Disease Control and Prevention, Zhenjiang, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Hong', 'Affiliation': 'Nanjing Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Chunzao', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': 'Yan Cheng Center for Disease Control and Prevention, Yancheng, China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Wan', 'Affiliation': 'Jiangsu Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Buys', 'Affiliation': 'School of Medicine, Griffith University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Yongqing', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Jiangsu Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'School of Medicine, Griffith University, Gold Coast, QLD, Australia.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00719']
2476,32793044,"Novel Mat Exergaming to Improve the Physical Performance, Cognitive Function, and Dual-Task Walking and Decrease the Fall Risk of Community-Dwelling Older Adults.","Physical exercise and cognitive training were previously demonstrated to improve the physical functioning and decrease the incidence of falls for older adults. This study aimed to utilize an interactive exergame mat system to develop a novel cognitive-physical training program and explore the training effects on physical performance, cognitive function, dual-task walking (DTW), and fall risk compared to the control condition. In this quasi-experimental non-randomized controlled intervention study, 110 community-dwelling older adults participated. The exercise group ( n  = 56; mean age, 70.7 ± 4.6 years) performed ladder-type, three-by-three grid-type, and circle-type mat exergames with simultaneous cognitive-physical training (EMAT), while the control group ( n  = 54; mean age, 72.0 ± 5.7 years) underwent a multicomponent exercise intervention focused on physical and cognitive training. A 2 h training session was completed weekly for 3 months. Functional fitness (including upper- and lower-extremity strength and flexibility, grasp strength, aerobic endurance, static balance, dynamic balance and agility), a foot tapping test (FTT), the Montreal Cognitive Assessment (MoCA), DTW, and a fall risk questionnaire (FRQ) were assessed before and after the interventions. The EMAT program enhanced upper-extremity strength, lower-extremity strength and flexibility, aerobic endurance, and dynamic balance and agility; improved DTW and FTT performances; and decreased FRQ score. EMAT also showed a significant advantage over control in terms of lower-extremity strength and flexibility, aerobic endurance, dynamic balance and agility, and FRQ score (all  P  < 0.05). The current study provides evidence of the effects of a novel mat exergaming program on physical and cognitive performance. EMAT effectively reduced the fall risk and increased the dual-task ability of walking, factors that are important in fall prevention for community-dwelling older adults.",2020,"EMAT also showed a significant advantage over control in terms of lower-extremity strength and flexibility, aerobic endurance, dynamic balance and agility, and FRQ score (all  P  < 0.05).","['older adults', ' n  = 54; mean age, 72.0 ± 5.7 years) underwent a', 'community-dwelling older adults', 'Community-Dwelling Older Adults', '110 community-dwelling older adults participated']","['ladder-type, three-by-three grid-type, and circle-type mat exergames with simultaneous cognitive-physical training (EMAT), while the control group', 'Physical exercise and cognitive training', 'multicomponent exercise intervention focused on physical and cognitive training', 'novel mat exergaming program']","['physical and cognitive performance', 'Physical Performance, Cognitive Function, and Dual-Task Walking', 'upper-extremity strength, lower-extremity strength and flexibility, aerobic endurance, and dynamic balance and agility; improved DTW and FTT performances; and decreased FRQ score', 'physical performance, cognitive function, dual-task walking (DTW), and fall risk', 'fall risk and increased the dual-task ability of walking, factors', 'physical functioning', 'Functional fitness (including upper- and lower-extremity strength and flexibility, grasp strength, aerobic endurance, static balance, dynamic balance and agility), a foot tapping test (FTT), the Montreal Cognitive Assessment (MoCA), DTW, and a fall risk questionnaire (FRQ', 'lower-extremity strength and flexibility, aerobic endurance, dynamic balance and agility, and FRQ score']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C0336762', 'cui_str': 'Ladder'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C0066317', 'cui_str': 'methylallyl trisulfide'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C1561668', 'cui_str': 'History of fall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",110.0,0.00959424,"EMAT also showed a significant advantage over control in terms of lower-extremity strength and flexibility, aerobic endurance, dynamic balance and agility, and FRQ score (all  P  < 0.05).","[{'ForeName': 'Hsien-Te', 'Initials': 'HT', 'LastName': 'Peng', 'Affiliation': 'Department of Physical Education, Chinese Culture University, Taipei, Taiwan.'}, {'ForeName': 'Cheng-Wen', 'Initials': 'CW', 'LastName': 'Tien', 'Affiliation': 'Department of Physical Education, Chinese Culture University, Taipei, Taiwan.'}, {'ForeName': 'Pay-Shin', 'Initials': 'PS', 'LastName': 'Lin', 'Affiliation': 'Department of Physical Therapy and Graduate Institute of Rehabilitation Science, College of Medicine, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Hsuen-Ying', 'Initials': 'HY', 'LastName': 'Peng', 'Affiliation': 'Department of Exercise and Health Science, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.'}, {'ForeName': 'Chen-Yi', 'Initials': 'CY', 'LastName': 'Song', 'Affiliation': 'Department of Long-Term Care, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01620']
2477,32793403,Two-year long safety and efficacy of deferasirox film-coated tablets in patients with thalassemia or lower/intermediate risk MDS: phase 3 results from a subset of patients previously treated with deferasirox in the ECLIPSE study.,"Background


Despite the proven benefits of iron chelation therapy (ICT) in the management of chronic iron overload and related complications, compliance to long-term ICT is challenging. Results from the ECLIPSE study, an open-label, randomized, multicenter, 2-arm, phase 2 study evaluated the safety of deferasirox dispersible tablet and film-coated tablet (FCT) formulations in patients with transfusion-dependent thalassemia (TDT) or very low, low, or intermediate risk myelodysplastic syndrome (MDS) treated over 24 weeks.
Methods


The aim of the current study (a 2-year, open-label, multicenter, single-arm, phase 3 study) is to evaluate the long-term safety and efficacy of deferasirox FCT in a subset of patients with TDT or lower/intermediate-risk MDS treated for 2 years after the completion of 24 weeks of treatment with deferasirox in the ECLIPSE phase 2 study.
Results


Of 53 patients enrolled, 34 (64.2%) completed treatment and study. Adverse events (AEs) reported in most patients (~ 70%) were of mild to moderate severity. Headache and diarrhea were the most frequently (> 25%) reported AEs. None of the serious AEs (including 1 death) were considered treatment related. No new safety signal was identified, and long-term safety of deferasirox FCT was consistent with the known safety profile of deferasirox. No major concerns associated with gastrointestinal tolerability, renal safety, or hematological abnormalities (thrombocytopenia/neutropenia) were reported during the 2 years. Patients receiving deferasirox FCT had a treatment compliance (by pill count) of ~ 90% and persistence (continuous use for ≥ 30 days) of > 95%. Reduction in serum ferritin level was almost consistent starting from week 2 across all post-baseline time points (relative reduction: month 6, 19%; month 12, 29%).
Conclusions


The results from this 2-year interventional study suggest that the recommended dosing of deferasirox FCT, with better tolerability, palatability, and compliance, offers a favorable option of ICT for long-term management of iron overload and associated complications in TDT. Trial registration  ClinicalTrials.gov, NCT02720536. Registered 28 March 2016, https://www.clinicaltrials.gov/ct2/show/NCT02720536.",2020,"No major concerns associated with gastrointestinal tolerability, renal safety, or hematological abnormalities (thrombocytopenia/neutropenia) were reported during the 2 years.","['53 patients enrolled, 34 (64.2%) completed treatment and study', 'patients with thalassemia or lower/intermediate risk MDS', 'patients previously treated with deferasirox in the ECLIPSE study', 'patients with transfusion-dependent thalassemia (TDT) or very low, low, or intermediate risk myelodysplastic syndrome (MDS) treated over 24\xa0weeks', 'patients with TDT or lower/intermediate-risk MDS treated for 2\xa0years after the completion of 24\xa0weeks of treatment with deferasirox in the ECLIPSE phase 2 study']","['deferasirox dispersible tablet and film-coated tablet (FCT) formulations', 'iron chelation therapy (ICT', 'deferasirox film-coated tablets', 'deferasirox FCT']","['gastrointestinal tolerability, renal safety, or hematological abnormalities (thrombocytopenia/neutropenia', 'tolerability, palatability, and compliance', 'Adverse events (AEs', 'serum ferritin level', 'Headache and diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039730', 'cui_str': 'Thalassemia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C2347761', 'cui_str': 'Childhood myelodysplastic syndrome'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1619629', 'cui_str': 'deferasirox'}, {'cui': 'C4760934', 'cui_str': 'Transfusion dependent thalassaemia'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}]","[{'cui': 'C1619629', 'cui_str': 'deferasirox'}, {'cui': 'C0991504', 'cui_str': 'Disintegrating Oral Tablet'}, {'cui': 'C1273643', 'cui_str': 'Film-coated tablet'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0007975', 'cui_str': 'Chelation therapy'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",53.0,0.0729343,"No major concerns associated with gastrointestinal tolerability, renal safety, or hematological abnormalities (thrombocytopenia/neutropenia) were reported during the 2 years.","[{'ForeName': 'Immacolata', 'Initials': 'I', 'LastName': 'Tartaglione', 'Affiliation': 'Department of Woman, Child and of General and Specialist Surgery, University of Campania Luigi Vanvitelli, Naples, Italy.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Origa', 'Affiliation': 'Ospedale Pediatrico Microcitemico ""A.Cao,"" A.O. ""G.Brotzu"", Cagliari, Italy.'}, {'ForeName': 'Antonis', 'Initials': 'A', 'LastName': 'Kattamis', 'Affiliation': 'Division of Pediatric Hematology-Oncology, First Department of Pediatrics, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pfeilstöcker', 'Affiliation': 'Third Medical Department, Hanusch Hospital, Vienna, Austria.'}, {'ForeName': 'Sibel', 'Initials': 'S', 'LastName': 'Gunes', 'Affiliation': 'Novartis Farma SPA, Origgio, Lombardy Italy.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Crowe', 'Affiliation': 'Novartis Ireland Limited, Dublin, Ireland.'}, {'ForeName': 'Niamh', 'Initials': 'N', 'LastName': 'Fagan', 'Affiliation': 'Novartis Ireland Limited, Dublin, Ireland.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Vincenzi', 'Affiliation': 'Novartis Farma SPA, Origgio, Lombardy Italy.'}, {'ForeName': 'Giovan Battista', 'Initials': 'GB', 'LastName': 'Ruffo', 'Affiliation': 'U.O.C. Ematologia e Talassemia, A.O. Civico-Di Cristina-Benfratelli, Piazza Nicola Leotta 4, 90127 Palermo, Italy.'}]",Experimental hematology & oncology,['10.1186/s40164-020-00174-2']
2478,32793485,Increased Dose to Organs in Urinary Tract Associates With Measures of Genitourinary Toxicity in Pooled Voxel-Based Analysis of 3 Randomized Phase III Trials.,"Purpose:  Dose information from organ sub-regions has been shown to be more predictive of genitourinary toxicity than whole organ dose volume histogram information. This study aimed to identify anatomically-localized regions where 3D dose is associated with genitourinary toxicities in healthy tissues throughout the pelvic anatomy.  Methods and Materials:  Dose distributions for up to 656 patients of the Trans-Tasman Radiation Oncology Group 03.04 RADAR trial were deformably registered onto a single exemplar CT dataset. Voxel- based multiple comparison permutation dose difference testing, Cox regression modeling and LASSO feature selection were used to identify regions where 3D dose-increase was associated with late grade ≥ 2 genitourinary dysuria, incontinence and frequency, and late grade ≥ 1 haematuria. This was externally validated by registering dose distributions from the RT01 (up to  n  = 388) and CHHiP (up to  n  = 247) trials onto the same exemplar and repeating the voxel-based tests on each of these data sets. All three datasets were then combined, and the tests repeated.  Results:  Voxel-based Cox regression and multiple comparison permutation dose difference testing revealed regions where increased dose was correlated with genitourinary toxicity. Increased dose in the vicinity of the membranous and spongy urethra was associated with dysuria for all datasets. Haematuria was similarly correlated with increased dose at the membranous and spongy urethra, for the RADAR, CHHiP, and combined datasets. Some evidence was found for the association between incontinence and increased dose at the internal and external urethral sphincter for RADAR and the internal sphincter alone for the combined dataset. Incontinence was also strongly correlated with dose from posterior oblique beams. Patients with fields extending inferiorly and posteriorly to the CTV, adjacent to the membranous and spongy urethra, were found to experience increased frequency.  Conclusions:  Anatomically-localized dose-toxicity relationships were determined for late genitourinary symptoms in the urethra and urinary sphincters. Low-intermediate doses to the extraprostatic urethra were associated with risk of late dysuria and haematuria, while dose to the urinary sphincters was associated with incontinence.",2020,"Low-intermediate doses to the extraprostatic urethra were associated with risk of late dysuria and haematuria, while dose to the urinary sphincters was associated with incontinence.",[],['CHHiP'],"['Haematuria', 'genitourinary toxicity', 'Incontinence']",[],[],"[{'cui': 'C0018965', 'cui_str': 'Blood in urine'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}]",,0.0218456,"Low-intermediate doses to the extraprostatic urethra were associated with risk of late dysuria and haematuria, while dose to the urinary sphincters was associated with incontinence.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Marcello', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, WA, Australia.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Denham', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Kennedy', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, WA, Australia.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Haworth', 'Affiliation': 'School of Physics, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Steigler', 'Affiliation': 'Prostate Cancer Trials Group, School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Greer', 'Affiliation': 'School of Mathematical and Physical Sciences, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Lois C', 'Initials': 'LC', 'LastName': 'Holloway', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, Liverpool, NSW, Australia.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Dowling', 'Affiliation': 'School of Mathematical and Physical Sciences, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Jameson', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, Liverpool, NSW, Australia.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Roach', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, Liverpool, NSW, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Joseph', 'Affiliation': 'School of Surgery, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Gulliford', 'Affiliation': 'Radiotherapy Department, University College London Hospitals NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Dearnaley', 'Affiliation': 'Academic UroOncology Unit, The Institute of Cancer Research and the Royal Marsden NHS Trust, London, United Kingdom.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'MRC Clinical Trials Unit, Medical Research Council, London, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Ebert', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, WA, Australia.'}]",Frontiers in oncology,['10.3389/fonc.2020.01174']
2479,32793536,Effects of Whole Body Electromyostimulation on Physical Fitness and Health in Postmenopausal Women: A Study Protocol for a Randomized Controlled Trial.,"Background:  Age-related problems such as chronic diseases, functional limitation and dependence, reduce the quality of life in the elderly, and increase public spending in health. It has been established that physical activity plays a fundamental role in the health of the elderly. The whole body electromyostimulation (WB-EMS) could be a successful methodology as high-intensity training to improve the physical fitness of older people.  Methods:  A minimum of 13 women between 55 and 70 years old will be randomized in two groups. The exercise with WB-EMS group (EX + WB-EMS) will conduct a resistance strength training program with superimposed WB-EMS while the exercise group (EX) will perform only resistance strength and aerobic training. Balance, strength, flexibility, agility, speed, and aerobic performance (EXERNET battery and progressive resistance test), as well as body composition, blood parameters and physical activity reporting (IPAQ-E) will be assessed to analyze the effects of whole body electromyostimulation in the physical fitness and the health in postmenopausal women.  Discussion:  Innovative and scientifically well-designed protocols are needed to enhance the knowledge of the body's responses within this training methodology which is being used by a big quantity of population. This trial will provide evidence on the effectiveness of whole-body electromyostimulation in physical fitness and health in elderly women.  Trial Registration:  ISRCTN15558857 registration data: 27/11/2019 (retrospectively registered).",2020,"Balance, strength, flexibility, agility, speed, and aerobic performance (EXERNET battery and progressive resistance test), as well as body composition, blood parameters and physical activity reporting (IPAQ-E) will be assessed to analyze the effects of whole body electromyostimulation in the physical fitness and the health in postmenopausal women.  ","['Postmenopausal Women', 'postmenopausal women', '13 women between 55 and 70 years old', 'elderly women']","['whole-body electromyostimulation', 'Whole Body Electromyostimulation', 'exercise with WB-EMS group (EX + WB-EMS']","['Balance, strength, flexibility, agility, speed, and aerobic performance (EXERNET battery and progressive resistance test), as well as body composition, blood parameters and physical activity reporting (IPAQ-E', 'Physical Fitness and Health']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0305683,"Balance, strength, flexibility, agility, speed, and aerobic performance (EXERNET battery and progressive resistance test), as well as body composition, blood parameters and physical activity reporting (IPAQ-E) will be assessed to analyze the effects of whole body electromyostimulation in the physical fitness and the health in postmenopausal women.  ","[{'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Pano-Rodriguez', 'Affiliation': 'Research Group Human Movement, University of Lleida, Lleida, Spain.'}, {'ForeName': 'Jose Vicente', 'Initials': 'JV', 'LastName': 'Beltran-Garrido', 'Affiliation': 'EUSES Health and Sport Sciences School, Rovira i Virgili University, Tarragona, Spain.'}, {'ForeName': 'Vicenç', 'Initials': 'V', 'LastName': 'Hernandez-Gonzalez', 'Affiliation': 'Research Group Human Movement, University of Lleida, Lleida, Spain.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Reverter-Masia', 'Affiliation': 'Research Group Human Movement, University of Lleida, Lleida, Spain.'}]",Frontiers in public health,['10.3389/fpubh.2020.00313']
2480,32793670,Effects of intravenous and inhalation anesthesia on blood glucose and complications in patients with type 2 diabetes mellitus: study protocol for a randomized controlled trial.,"Background


Diabetes mellitus (DM) is a metabolic disorder syndrome caused by relative or absolute lack of insulin and varying degrees of insulin resistance. The type and regimen of anesthesia may affect perioperative hyperglycemia following major surgical stress. The effect of perioperative anesthetics on the blood glucose level of diabetic patients will play an essential role in the postoperative recovery of patients. However, there is no rigorously-designed randomized controlled trial to compare the effects of total intravenous anesthesia (TIVA) and total inhalation anesthesia (TIHA) on blood glucose and complications in type 2 diabetes. Hence, we design this clinical trial to compare the effects of TIVA and TIHA of hyperglycemia and clinical outcomes in type 2 diabetes undergoing surgery.
Methods


This is a randomized, double-blind, parallel controlled trial. One hundred twelve patients with type 2 DM who meet the qualification criteria will be randomly divided into two groups: TIVA group and TIHA group. The levels of serum insulin and cortisol will be measured before and after the operation, and the levels of blood glucose at different setting time will be monitored. All patients will be followed up by blinded evaluators at baseline and 1, 3, 7, and 30 days after the intervention. The follow-up included postoperative complications [such as myocardial infarction (MI), stroke, renal failure, anastomotic fistula, stress ulcer, incision infection, lung infection] and adverse events.
Discussion


The routinely used clinical anesthesia schemes are TIVA, TIHA and intravenous-inhalation combined anesthesia. We expect that the results of this trial will provide high-quality clinical evidence for the choice of anesthesia options for patients with type 2 DM.
Trial registration


Chinese Clinical Trial Registry: ChiCTR2000029247, registration date: 20 January 2020.",2020,One hundred twelve patients with type 2 DM who meet the qualification criteria will be randomly divided into two groups: TIVA group and TIHA group.,"['patients with type 2 DM', 'type 2 diabetes undergoing surgery', 'patients with type 2 diabetes mellitus', '20 January 2020', 'major surgical stress', 'diabetic patients', 'type 2 diabetes', 'One hundred twelve patients with type 2 DM who meet the qualification criteria']","['intravenous and inhalation anesthesia', 'total intravenous anesthesia (TIVA) and total inhalation anesthesia (TIHA', 'TIVA group and TIHA', 'TIVA and TIHA', 'perioperative anesthetics']","['blood glucose and complications', 'blood glucose level', 'perioperative hyperglycemia', 'levels of serum insulin and cortisol', 'levels of blood glucose', 'postoperative complications [such as myocardial infarction (MI), stroke, renal failure, anastomotic fistula, stress ulcer, incision infection, lung infection] and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002917', 'cui_str': 'Anesthesia, Inhalation'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C2609055', 'cui_str': 'Anastomotic fistula'}, {'cui': 'C0400807', 'cui_str': 'Stress ulcer of stomach'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",112.0,0.21583,One hundred twelve patients with type 2 DM who meet the qualification criteria will be randomly divided into two groups: TIVA group and TIHA group.,"[{'ForeName': 'Xing-Hui', 'Initials': 'XH', 'LastName': 'Xiong', 'Affiliation': 'Department of Anesthesiology and Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology and Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology and Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': 'Department of Anesthesiology and Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Qian-Yao', 'Initials': 'QY', 'LastName': 'Deng', 'Affiliation': 'Department of Anesthesiology and Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xing-Wei', 'Initials': 'XW', 'LastName': 'Cai', 'Affiliation': 'Department of Anesthesiology and Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Liang', 'Affiliation': 'Department of Anesthesiology and Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology and Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, China.'}]",Annals of translational medicine,['10.21037/atm-20-2045a']
2481,32793705,Minimum local anesthetic dose of ropivacaine in real-time ultrasound-guided intraspinal anesthesia for lower extremity surgery: a randomized controlled trial.,"Background


Despite the many advantages real-time ultrasound-guided lumbar anesthesia has over traditional lumbar anesthesia, it seemingly involves a much higher dose of ropivacaine. This study aimed to determine the minimum local anesthetic dose (MLAD) and the 95% confidence interval of ropivacaine at different concentrations in real-time ultrasound-guided lumbar anesthesia for lower extremity surgery.
Methods


A total of 60 patients who were consecutively scheduled for selective lower extremity surgery were enrolled. The patients were randomly divided into two groups, which each received different concentrations of ropivacaine at different initial dosages when Dixon's up-and-down sequential method was applied. The high ropivacaine group and the low ropivacaine group received 0.75% and 0.5% ropivacaine, respectively. The patients' baseline characteristics, the MLAD, and the 95% confidence interval were assessed. The highest level of sensory block, time to reach the T10 sensory block, duration for sensory blocks higher than T10, highest plane for sensory block, and onset time and duration for motor block were recorded. Comparisons were also made between the patients' vital signs and adverse reactions.
Results


The minimum local anaesthetic dose (MLAD) and 95% confidence interval in the high ropivacaine group and the low ropivacaine group were 17.176 (16.276 to 18.124) and 20.192 (19.256 to 21.174) mg, respectively. Moreover, motor block maintenance was greatly reduced in the 0.5% ropivacaine compared to the 0.75% ropivacaine group (P=0.0309).
Conclusions


In real-time ultrasound-guided intraspinal anesthesia for lower extremity surgery, both 0.75% and 0.5% ropivacaine provide satisfactory anesthesia. Our results suggest that shortened motor block duration can hold benefits for patients including earlier mobilization and a quicker rehabilitation process.",2020,"Moreover, motor block maintenance was greatly reduced in the 0.5% ropivacaine compared to the 0.75% ropivacaine group (P=0.0309).
","['lower extremity surgery', '60 patients who were consecutively scheduled for selective lower extremity surgery were enrolled']",['ropivacaine'],"['minimum local anaesthetic dose (MLAD', 'vital signs and adverse reactions', 'highest level of sensory block, time to reach the T10 sensory block, duration for sensory blocks higher than T10, highest plane for sensory block, and onset time and duration for motor block', 'motor block maintenance']","[{'cui': 'C0187763', 'cui_str': 'Surgical procedure on lower extremity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",60.0,0.075719,"Moreover, motor block maintenance was greatly reduced in the 0.5% ropivacaine compared to the 0.75% ropivacaine group (P=0.0309).
","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zheng', 'Affiliation': 'Department of Anaesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Ye', 'Affiliation': 'Department of Anaesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, China.'}, {'ForeName': 'Weilan', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Anaesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Hu', 'Affiliation': 'Department of Anaesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Lifei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Anaesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, China.'}, {'ForeName': 'Xiaochun', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Department of Anaesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, China.'}, {'ForeName': 'Mingxue', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Department of Anaesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, China.'}]",Annals of translational medicine,['10.21037/atm-20-3805']
2482,32791894,Effects of Olanzapine Combined With Samidorphan on Weight Gain in Schizophrenia: A 24-Week Phase 3 Study.,"OBJECTIVE


A combination of olanzapine and the opioid receptor antagonist samidorphan is under development for the treatment of schizophrenia and bipolar I disorder. The single-tablet combination treatment is intended to provide the efficacy of olanzapine while mitigating olanzapine-associated weight gain. In this phase 3 double-blind trial, the authors evaluated the weight profile of combined olanzapine/samidorphan compared with olanzapine in patients with schizophrenia.
METHODS


Adults (ages 18‒55 years) with schizophrenia were randomly assigned to receive either combination treatment with olanzapine and samidorphan or olanzapine treatment for 24 weeks. Primary endpoints were percent change from baseline in body weight and proportion of patients with ≥10% weight gain at week 24. The key secondary endpoint was the proportion of patients with ≥7% weight gain. Waist circumference and fasting metabolic laboratory parameters were also measured.
RESULTS


Of 561 patients who underwent randomization (olanzapine/samidorphan combination, N=280; olanzapine, N=281), 538 had at least one postbaseline weight assessment. At week 24, the least squares mean percent weight change from baseline was 4.21% (SE=0.68) in the olanzapine/samidorphan group and 6.59% (SE=0.67) in the olanzapine group (the difference of -2.38% [SE=0.76] was significant). Significantly fewer patients in the olanzapine/samidorphan combination group compared with the olanzapine group had weight gain ≥10% (17.8% and 29.8%, respectively; number needed to treat [NNT]=7.29; odds ratio=0.50) and weight gain ≥7% (27.5% and 42.7%, respectively; NNT=6.29; odds ratio=0.50). Increases in waist circumference were smaller in the olanzapine/samidorphan combination group compared with the olanzapine group. Schizophrenia symptom improvement was similar between treatment groups. Adverse events (in ≥10% of the groups) in the olanzapine/samidorphan and olanzapine groups included weight gain (24.8% and 36.2%), somnolence (21.2% and 18.1%), dry mouth (12.8% and 8.0%), and increased appetite (10.9% and 12.3%). Metabolic changes were small and similar between treatments.
CONCLUSIONS


Olanzapine/samidorphan combination treatment was associated with significantly less weight gain and smaller increases in waist circumference than olanzapine and was well tolerated. The antipsychotic efficacy of the combination treatment was similar to that of olanzapine monotherapy.",2020,Increases in waist circumference were smaller in the olanzapine/samidorphan combination group compared with the olanzapine group.,"['561 patients who underwent randomization (olanzapine/samidorphan combination, N=280', 'Schizophrenia', ' N=281), 538 had at least one postbaseline weight assessment', 'patients with schizophrenia', 'Adults (ages 18‒55 years) with schizophrenia']","['olanzapine', 'olanzapine/samidorphan combination', 'olanzapine/samidorphan', 'Olanzapine Combined With Samidorphan', 'Olanzapine/samidorphan combination', 'olanzapine and samidorphan or olanzapine', 'olanzapine/samidorphan and olanzapine', ' olanzapine', 'olanzapine monotherapy']","['proportion of patients with ≥7% weight gain', 'waist circumference', 'Adverse events', 'body weight and proportion of patients with ≥10% weight gain', 'Metabolic changes', 'Waist circumference and fasting metabolic laboratory parameters', 'weight gain', 'tolerated', 'Schizophrenia symptom improvement', 'appetite', 'Weight Gain', 'weight profile', 'somnolence', 'antipsychotic efficacy', 'dry mouth']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C4277369', 'cui_str': '3-carboxamido-4-hydroxynaltrexone'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C4277369', 'cui_str': '3-carboxamido-4-hydroxynaltrexone'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}]",561.0,0.0487214,Increases in waist circumference were smaller in the olanzapine/samidorphan combination group compared with the olanzapine group.,"[{'ForeName': 'Christoph U', 'Initials': 'CU', 'LastName': 'Correll', 'Affiliation': 'Department of Psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, N.Y. (Correll); Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, N.Y. (Correll); Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin (Correll); Thriving Mind South Florida, Miami (Newcomer); Department of Psychiatry, Washington University School of Medicine, St. Louis (Newcomer); Alkermes, Inc., Waltham, Mass. (Silverman, DiPetrillo, Graham, Jiang, Du, Simmons, Hopkinson); Alkermes Pharma Ireland, Dublin (McDonnell); and Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Kahn).'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Newcomer', 'Affiliation': 'Department of Psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, N.Y. (Correll); Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, N.Y. (Correll); Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin (Correll); Thriving Mind South Florida, Miami (Newcomer); Department of Psychiatry, Washington University School of Medicine, St. Louis (Newcomer); Alkermes, Inc., Waltham, Mass. (Silverman, DiPetrillo, Graham, Jiang, Du, Simmons, Hopkinson); Alkermes Pharma Ireland, Dublin (McDonnell); and Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Kahn).'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Silverman', 'Affiliation': 'Department of Psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, N.Y. (Correll); Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, N.Y. (Correll); Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin (Correll); Thriving Mind South Florida, Miami (Newcomer); Department of Psychiatry, Washington University School of Medicine, St. Louis (Newcomer); Alkermes, Inc., Waltham, Mass. (Silverman, DiPetrillo, Graham, Jiang, Du, Simmons, Hopkinson); Alkermes Pharma Ireland, Dublin (McDonnell); and Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Kahn).'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'DiPetrillo', 'Affiliation': 'Department of Psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, N.Y. (Correll); Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, N.Y. (Correll); Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin (Correll); Thriving Mind South Florida, Miami (Newcomer); Department of Psychiatry, Washington University School of Medicine, St. Louis (Newcomer); Alkermes, Inc., Waltham, Mass. (Silverman, DiPetrillo, Graham, Jiang, Du, Simmons, Hopkinson); Alkermes Pharma Ireland, Dublin (McDonnell); and Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Kahn).'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Graham', 'Affiliation': 'Department of Psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, N.Y. (Correll); Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, N.Y. (Correll); Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin (Correll); Thriving Mind South Florida, Miami (Newcomer); Department of Psychiatry, Washington University School of Medicine, St. Louis (Newcomer); Alkermes, Inc., Waltham, Mass. (Silverman, DiPetrillo, Graham, Jiang, Du, Simmons, Hopkinson); Alkermes Pharma Ireland, Dublin (McDonnell); and Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Kahn).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, N.Y. (Correll); Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, N.Y. (Correll); Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin (Correll); Thriving Mind South Florida, Miami (Newcomer); Department of Psychiatry, Washington University School of Medicine, St. Louis (Newcomer); Alkermes, Inc., Waltham, Mass. (Silverman, DiPetrillo, Graham, Jiang, Du, Simmons, Hopkinson); Alkermes Pharma Ireland, Dublin (McDonnell); and Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Kahn).'}, {'ForeName': 'Yangchun', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Department of Psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, N.Y. (Correll); Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, N.Y. (Correll); Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin (Correll); Thriving Mind South Florida, Miami (Newcomer); Department of Psychiatry, Washington University School of Medicine, St. Louis (Newcomer); Alkermes, Inc., Waltham, Mass. (Silverman, DiPetrillo, Graham, Jiang, Du, Simmons, Hopkinson); Alkermes Pharma Ireland, Dublin (McDonnell); and Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Kahn).'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Simmons', 'Affiliation': 'Department of Psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, N.Y. (Correll); Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, N.Y. (Correll); Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin (Correll); Thriving Mind South Florida, Miami (Newcomer); Department of Psychiatry, Washington University School of Medicine, St. Louis (Newcomer); Alkermes, Inc., Waltham, Mass. (Silverman, DiPetrillo, Graham, Jiang, Du, Simmons, Hopkinson); Alkermes Pharma Ireland, Dublin (McDonnell); and Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Kahn).'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Hopkinson', 'Affiliation': 'Department of Psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, N.Y. (Correll); Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, N.Y. (Correll); Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin (Correll); Thriving Mind South Florida, Miami (Newcomer); Department of Psychiatry, Washington University School of Medicine, St. Louis (Newcomer); Alkermes, Inc., Waltham, Mass. (Silverman, DiPetrillo, Graham, Jiang, Du, Simmons, Hopkinson); Alkermes Pharma Ireland, Dublin (McDonnell); and Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Kahn).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McDonnell', 'Affiliation': 'Department of Psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, N.Y. (Correll); Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, N.Y. (Correll); Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin (Correll); Thriving Mind South Florida, Miami (Newcomer); Department of Psychiatry, Washington University School of Medicine, St. Louis (Newcomer); Alkermes, Inc., Waltham, Mass. (Silverman, DiPetrillo, Graham, Jiang, Du, Simmons, Hopkinson); Alkermes Pharma Ireland, Dublin (McDonnell); and Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Kahn).'}, {'ForeName': 'René S', 'Initials': 'RS', 'LastName': 'Kahn', 'Affiliation': 'Department of Psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, N.Y. (Correll); Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, N.Y. (Correll); Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin (Correll); Thriving Mind South Florida, Miami (Newcomer); Department of Psychiatry, Washington University School of Medicine, St. Louis (Newcomer); Alkermes, Inc., Waltham, Mass. (Silverman, DiPetrillo, Graham, Jiang, Du, Simmons, Hopkinson); Alkermes Pharma Ireland, Dublin (McDonnell); and Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Kahn).'}]",The American journal of psychiatry,['10.1176/appi.ajp.2020.19121279']
2483,32791940,Prior antiplatelet therapy in patients undergoing endovascular treatment for acute ischemic stroke: Results from the MR CLEAN Registry.,"BACKGROUND


Antiplatelet therapy may increase the risk of symptomatic intracranial hemorrhage after endovascular treatment for ischemic stroke but may also have a beneficial effect on functional outcome. The aim of this study is to compare safety and efficacy outcomes after endovascular treatment in patients with and without prior antiplatelet therapy.
METHODS


We analyzed patients registered in the MR CLEAN Registry between March 2014 and November 2017, for whom data on antiplatelet therapy were available. We used propensity score nearest-neighbor matching with replacement to balance the probability of receiving prior antiplatelet therapy between the prior antiplatelet therapy and no prior antiplatelet therapy group and adjusted for baseline prognostic factors to compare these groups. Primary outcome was symptomatic intracranial hemorrhage. Secondary outcomes were 90-day functional outcome (modified Rankin Scale), successful reperfusion (extended thrombolysis in cerebral infarction score ≥2B) and 90-day mortality.
RESULTS


Thirty percent ( n  = 937) of the 3154 patients were on prior antiplatelet therapy, who were matched to 477 patients not on prior antiplatelet therapy. Symptomatic intracranial hemorrhage occurred in 74/937 (7.9%) patients on prior antiplatelet therapy and in 27/477 (5.6%) patients without prior antiplatelet therapy adjusted odds ratio 1.47, 95% confidence interval 0.86-2.49. No associations were found between prior antiplatelet therapy and functional outcome (adjusted common odds ratio 0.87, 95% confidence interval 0.65-1.16), successful reperfusion (adjusted odds ratio 1.23, 95% confidence interval 0.77-1.97), or 90-day mortality (adjusted odds ratio 1.15, 95% confidence interval 0.86-1.54).
CONCLUSION


We found no evidence of an association of prior antiplatelet therapy with the risk of symptomatic intracranial hemorrhage after endovascular treatment, nor on functional outcome, reperfusion, or mortality. A substantial beneficial or detrimental effect of antiplatelet therapy on clinical outcome cannot be excluded. A randomized clinical trial comparing antiplatelet therapy versus no antiplatelet therapy is needed.",2020,"We found no evidence of an association of prior antiplatelet therapy with the risk of symptomatic intracranial hemorrhage after endovascular treatment, nor on functional outcome, reperfusion, or mortality.","['patients with and without prior antiplatelet therapy', 'patients undergoing endovascular treatment for acute ischemic stroke', 'Thirty percent ( n \u2009=\u2009937) of the 3154 patients were on prior antiplatelet therapy, who were matched to 477 patients not on prior antiplatelet therapy']",['antiplatelet therapy'],"['Symptomatic intracranial hemorrhage', 'functional outcome, reperfusion, or mortality', 'symptomatic intracranial hemorrhage', '90-day mortality', 'safety and efficacy outcomes', 'successful reperfusion', '90-day functional outcome (modified Rankin Scale), successful reperfusion (extended thrombolysis in cerebral infarction score ≥2B) and 90-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",3154.0,0.0716801,"We found no evidence of an association of prior antiplatelet therapy with the risk of symptomatic intracranial hemorrhage after endovascular treatment, nor on functional outcome, reperfusion, or mortality.","[{'ForeName': 'Rob A', 'Initials': 'RA', 'LastName': 'van de Graaf', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Sanne M', 'Initials': 'SM', 'LastName': 'Zinkstok', 'Affiliation': 'Department of Neurology, Tergooi, Hilversum, The Netherlands.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Chalos', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Robert-Jan B', 'Initials': 'RB', 'LastName': 'Goldhoorn', 'Affiliation': 'Department of Neurology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Charles Blm', 'Initials': 'CB', 'LastName': 'Majoie', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'van Oostenbrugge', 'Affiliation': 'Department of Neurology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Aad', 'Initials': 'A', 'LastName': 'van der Lugt', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Diederik Wj', 'Initials': 'DW', 'LastName': 'Dippel', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Yvo Bwem', 'Initials': 'YB', 'LastName': 'Roos', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Hester F', 'Initials': 'HF', 'LastName': 'Lingsma', 'Affiliation': 'Department of Public Health, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Adriaan Cgm', 'Initials': 'AC', 'LastName': 'van Es', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Roozenbeek', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493020946975']
2484,32791945,Effects of two different robot-assisted arm training on upper limb motor function and kinematics in chronic stroke survivors: A randomized controlled trial.,"BACKGROUND


Comparative studies of different robotic types are warranted to tailor robot-assisted upper limb training to patient's functional level.
OBJECTIVES


This study aimed to directly compare the effects of high inertia robot arm (whole arm manipulator, WAM) and low inertia robot arm (Proficio) on upper limb motor function in chronic stroke patients.
METHODS


In this randomized controlled trial, 40 chronic stroke survivors were randomized into robot-assisted arm training with WAM (RAT-WAM) and robot-assisted arm training with Proficio (RAT-P) groups. The RAT-WAM and RAT-P groups participated in the robot-assisted arm training with WAM and robot-assisted arm training with Proficio, respectively, for 40 min daily, three times weekly over a four week. Upper limb motor function was measured before and after the intervention using the Fugl-Meyer assessment (FMA), action research arm test, and box and block test (BBT). Curvilinearity ratio (the length ratio of a straight line from the start to the target) was also measured as an index for upper limb kinematic performance.
RESULTS


The RAT-WAM and RAT-P groups showed significant improvements in FMA-total and -proximal (shoulder/elbow units), BBT, and ARAT after the intervention ( P  < .05). Also, the RAT-P group showed significantly more improvement than the RAT-WAM group in FMA-distal (hand/wrist units) ( P  < .05).
CONCLUSIONS


Improvements of upper limb motor function occurred during robot-assisted arm training with robotic systems. Low inertia robot arm was more effective in improving the motor function of the hand and wrist. The results may be useful for robot-assisted training for upper limb impairment.",2020,"The RAT-WAM and RAT-P groups showed significant improvements in FMA-total and -proximal (shoulder/elbow units), BBT, and ARAT after the intervention ( P  < .05).","['chronic stroke survivors', '40 chronic stroke survivors', 'chronic stroke patients']","['robot-assisted arm training with WAM (RAT-WAM) and robot-assisted arm training with Proficio (RAT-P', 'RAT-WAM', 'robot-assisted arm training', 'high inertia robot arm (whole arm manipulator, WAM) and low inertia robot arm (Proficio', 'tailor robot-assisted upper limb training']","['FMA-total and -proximal (shoulder/elbow units), BBT, and ARAT', 'Upper limb motor function', 'Curvilinearity ratio (the length ratio of a straight line', 'upper limb motor function']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0556501', 'cui_str': 'Upper limb training'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1264673', 'cui_str': 'Arbitrary rate'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]",40.0,0.0480164,"The RAT-WAM and RAT-P groups showed significant improvements in FMA-total and -proximal (shoulder/elbow units), BBT, and ARAT after the intervention ( P  < .05).","[{'ForeName': 'Ki-Hun', 'Initials': 'KH', 'LastName': 'Cho', 'Affiliation': 'Department of Physical Therapy, Korea National University of Transportation , Chungbuk, Republic of Korea.'}, {'ForeName': 'Won-Kyung', 'Initials': 'WK', 'LastName': 'Song', 'Affiliation': 'Department of Rehabilitative & Assistive Technology, National Rehabilitation Research Institute, National Rehabilitation Center , Seoul, Republic of Korea.'}]",Topics in stroke rehabilitation,['10.1080/10749357.2020.1804699']
2485,32791950,Plaque Regression and Endothelial Progenitor Cell Mobilization With Intensive Lipid Elimination Regimen (PREMIER).,"BACKGROUND


Low-density lipoproteins (LDLs) are removed by extracorporeal filtration during LDL apheresis. It is mainly used in familial hyperlipidemia. The PREMIER trial (Plaque Regression and Progenitor Cell Mobilization With Intensive Lipid Elimination Regimen) evaluated LDL apheresis in nonfamilial hyperlipidemia acute coronary syndrome patients treated with percutaneous coronary intervention.
METHODS


We randomized 160 acute coronary syndrome patients at 4 Veterans Affairs centers within 72 hours of percutaneous coronary intervention to intensive lipid-lowering therapy (ILLT) comprising single LDL apheresis and statins versus standard medical therapy (SMT) with no LDL apheresis and statin therapy alone. Trial objectives constituted primary safety and primary efficacy end points and endothelial progenitor cell colony-forming unit mobilization in peripheral blood.
RESULTS


Mean LDL reduction at discharge was 53% in ILLT and 17% in SMT groups ( P <0.0001) from baseline levels of 116.3±34.3 and 110.7±32 mg/dL ( P =0.2979), respectively. The incidence of the primary safety end point of major peri-percutaneous coronary intervention adverse events was similar in both groups (ILLT, 3; SMT, 0). The primary efficacy end point, percentage change in total plaque volume at 90 days by intravascular ultrasound, on average decreased by 4.81% in the ILLT group and increased by 2.31% in the SMT group (difference of means, -7.13 [95% CI, -14.59 to 0.34];  P =0.0611). The raw change in total plaque volume on average decreased more in the ILLT group than in the SMT group (-6.01 versus -0.95 mm 3 ; difference of means, -5.06 [95% CI, -11.61 to 1.48];  P =0.1286). Similar results were obtained after adjusting for participating sites, age, preexisting coronary artery disease, diabetes mellitus, baseline LDL levels, and baseline plaque burden. There was robust endothelial progenitor cell colony-forming unit mobilization from baseline to 90 days in the ILLT group ( P =0.0015) but not in SMT ( P =0.0844).
CONCLUSIONS


PREMIER is the first randomized clinical trial to demonstrate safety and a trend for early coronary plaque regression with LDL apheresis in nonfamilial hyperlipidemia acute coronary syndrome patients treated with percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01004406 and NCT02347098.",2020,"RESULTS


Mean LDL reduction at discharge was 53% in ILLT and 17% in SMT groups ( P <0.0001) from baseline levels of 116.3±34.3 and 110.7±32 mg/dL ( P =0.2979), respectively.","['nonfamilial hyperlipidemia acute coronary syndrome patients treated with percutaneous coronary intervention', '160 acute coronary syndrome patients at 4 Veterans Affairs centers within 72 hours of']","['percutaneous coronary intervention to intensive lipid-lowering therapy (ILLT) comprising single LDL apheresis and statins versus standard medical therapy (SMT) with no LDL apheresis and statin therapy alone', 'ILLT', 'SMT', 'Intensive Lipid Elimination Regimen (PREMIER', 'LDL apheresis', 'endothelial progenitor cell colony-forming unit mobilization']","['Mean LDL reduction at discharge', 'total plaque volume', 'major peri-percutaneous coronary intervention adverse events', 'Plaque Regression and Endothelial Progenitor Cell Mobilization', 'endothelial progenitor cell colony-forming unit mobilization']","[{'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1292423', 'cui_str': '72 hours'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0949035', 'cui_str': 'Low density lipoprotein apheresis'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]",160.0,0.0519883,"RESULTS


Mean LDL reduction at discharge was 53% in ILLT and 17% in SMT groups ( P <0.0001) from baseline levels of 116.3±34.3 and 110.7±32 mg/dL ( P =0.2979), respectively.","[{'ForeName': 'Subhash', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Veterans Affairs North Texas Health Care System, Dallas (S.B., J.L.H.).'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Luo', 'Affiliation': 'Cooperative Studies Program Coordinating Center, Edward Hines, Jr Veterans Affairs Hospital, Hines, IL (P.L., D.J.R., D.L., Y.W.).'}, {'ForeName': 'Domenic J', 'Initials': 'DJ', 'LastName': 'Reda', 'Affiliation': 'Cooperative Studies Program Coordinating Center, Edward Hines, Jr Veterans Affairs Hospital, Hines, IL (P.L., D.J.R., D.L., Y.W.).'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Latif', 'Affiliation': 'Oklahoma City Veterans Affairs Medical Center (F.L.).'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Hastings', 'Affiliation': 'Veterans Affairs North Texas Health Care System, Dallas (S.B., J.L.H.).'}, {'ForeName': 'Ehrin J', 'Initials': 'EJ', 'LastName': 'Armstrong', 'Affiliation': 'Rocky Mountain Regional Veterans Affairs Medical Center, Aurora, CO (E.J.A.).'}, {'ForeName': 'Jayant', 'Initials': 'J', 'LastName': 'Bagai', 'Affiliation': 'Veterans Affairs Tennessee Valley Health Care System, Nashville (J.B.).'}, {'ForeName': 'Mazen', 'Initials': 'M', 'LastName': 'Abu-Fadel', 'Affiliation': 'University of Oklahoma Health Sciences Center (F.L., M.A.-F.).'}, {'ForeName': 'Amutharani', 'Initials': 'A', 'LastName': 'Baskar', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas (S.B., J.L.H., A.B., P.K.).'}, {'ForeName': 'Preeti', 'Initials': 'P', 'LastName': 'Kamath', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas (S.B., J.L.H., A.B., P.K.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lippe', 'Affiliation': 'Cooperative Studies Program Coordinating Center, Edward Hines, Jr Veterans Affairs Hospital, Hines, IL (P.L., D.J.R., D.L., Y.W.).'}, {'ForeName': 'Yongliang', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Cooperative Studies Program Coordinating Center, Edward Hines, Jr Veterans Affairs Hospital, Hines, IL (P.L., D.J.R., D.L., Y.W.).'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Scrymgeour', 'Affiliation': 'Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (A.S.).'}, {'ForeName': 'Theresa C', 'Initials': 'TC', 'LastName': 'Gleason', 'Affiliation': 'Department of Veterans Affairs, Office of Research and Development, Washington, DC (T.C.G.).'}, {'ForeName': 'Emmanouil S', 'Initials': 'ES', 'LastName': 'Brilakis', 'Affiliation': 'Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, MN (E.S.B.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008933']
2486,32792079,Optimum Blood Pressure in Patients With Shock After Acute Myocardial Infarction and Cardiac Arrest.,"BACKGROUND


In patients with shock after acute myocardial infarction (AMI), the optimal level of pharmacologic support is unknown. Whereas higher doses may increase myocardial oxygen consumption and induce arrhythmias, diastolic hypotension may reduce coronary perfusion and increase infarct size.
OBJECTIVES


This study aimed to determine the optimal mean arterial pressure (MAP) in patients with AMI and shock after cardiac arrest.
METHODS


This study used patient-level pooled analysis of post-cardiac arrest patients with shock after AMI randomized in the Neuroprotect (Neuroprotective Goal Directed Hemodynamic Optimization in Post-cardiac Arrest Patients; NCT02541591) and COMACARE (Carbon Dioxide, Oxygen and Mean Arterial Pressure After Cardiac Arrest and Resuscitation; NCT02698917) trials who were randomized to MAP 65 mm Hg or MAP 80/85 to 100 mm Hg targets during the first 36 h after admission. The primary endpoint was the area under the 72-h high-sensitivity troponin-T curve.
RESULTS


Of 235 patients originally randomized, 120 patients had AMI with shock. Patients assigned to the higher MAP target (n = 58) received higher doses of norepinephrine (p = 0.004) and dobutamine (p = 0.01) and reached higher MAPs (86 ± 9 mm Hg vs. 72 ± 10 mm Hg, p < 0.001). Whereas admission hemodynamics and angiographic findings were all well-balanced and revascularization was performed equally effective, the area under the 72-h high-sensitivity troponin-T curve was lower in patients assigned to the higher MAP target (median: 1.14 μg.72 h/l [interquartile range: 0.35 to 2.31 μg.72 h/l] vs. median: 1.56 μg.72 h/l [interquartile range: 0.61 to 4.72 μg. 72 h/l]; p = 0.04). Additional pharmacologic support did not increase the risk of a new cardiac arrest (p = 0.88) or atrial fibrillation (p = 0.94). Survival with good neurologic outcome at 180 days was not different between both groups (64% vs. 53%, odds ratio: 1.55; 95% confidence interval: 0.74 to 3.22).
CONCLUSIONS


In post-cardiac arrest patients with shock after AMI, targeting MAP between 80/85 and 100 mm Hg with additional use of inotropes and vasopressors was associated with smaller myocardial injury.",2020,Additional pharmacologic support did not increase the risk of a new cardiac arrest (p = 0.88) or atrial fibrillation (p = 0.94).,"['patients with AMI and shock after cardiac arrest', 'patients with shock after acute myocardial infarction (AMI', 'Patients With Shock', '235 patients originally randomized, 120 patients had AMI with shock']","['norepinephrine', 'MAP 65\xa0mm\xa0Hg or MAP 80/85 to 100\xa0mm', 'dobutamine', 'COMACARE (Carbon Dioxide, Oxygen and Mean Arterial Pressure']","['optimal mean arterial pressure (MAP', 'Survival with good neurologic outcome', 'sensitivity troponin-T curve', 'Optimum Blood Pressure', 'risk of a new cardiac arrest', 'area under the 72-h high-sensitivity troponin-T curve', 'atrial fibrillation', 'myocardial oxygen consumption and induce arrhythmias, diastolic hypotension', 'admission hemodynamics and angiographic findings']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0012963', 'cui_str': 'Dobutamine'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0428863', 'cui_str': 'Myocardial oxygen consumption'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0277890', 'cui_str': 'Decreased diastolic arterial pressure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}]",235.0,0.451132,Additional pharmacologic support did not increase the risk of a new cardiac arrest (p = 0.88) or atrial fibrillation (p = 0.94).,"[{'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Ameloot', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium. Electronic address: Koen.ameloot@zol.be.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Jakkula', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Hästbacka', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Reinikainen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University of Eastern Finland and Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Pettilä', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Loisa', 'Affiliation': 'Department of Intensive Care, Päijät-Häme Central Hospital, Lahti, Finland.'}, {'ForeName': 'Marjaana', 'Initials': 'M', 'LastName': 'Tiainen', 'Affiliation': 'Department of Neurology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Stepani', 'Initials': 'S', 'LastName': 'Bendel', 'Affiliation': 'Department of Intensive Care, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Birkelund', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Belmans', 'Affiliation': 'Department of Cardiology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Pieter-Jan', 'Initials': 'PJ', 'LastName': 'Palmers', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Bogaerts', 'Affiliation': 'Department of Cardiology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Lemmens', 'Affiliation': 'Department of Neurology, University Hospitals Leuven, Leuven, Belgium; VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium; KU Leuven-University of Leuven, Department of Neurosciences, Experimental Neurology, and Leuven Brain Institute (LBI), Leuven, Belgium.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'De Deyne', 'Affiliation': 'Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium; Department of Anesthesiology and Critical Care Medicine, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Ferdinande', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Dupont', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Janssens', 'Affiliation': 'Department of Cardiology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Dens', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium.'}, {'ForeName': 'Markus B', 'Initials': 'MB', 'LastName': 'Skrifvars', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Department of Emergency Medicine and Services, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.06.043']
2487,32792098,Artificial neural network model for preoperative prediction of severe liver failure after hemihepatectomy in patients with hepatocellular carcinoma.,"BACKGROUND


Posthepatectomy liver failure is a worrisome complication after major hepatectomy for hepatocellular carcinoma and is the leading cause of postoperative mortality. Recommendations for hepatectomy for hepatocellular carcinoma are based on the risk of severe posthepatectomy liver failure, and accurately predicting posthepatectomy liver failure risk before undertaking major hepatectomy is of great significance. Thus, herein, we aimed to establish and validate an artificial neural network model to predict severe posthepatectomy liver failure in patients with hepatocellular carcinoma who underwent hemihepatectomy.
METHODS


Three hundred and fifty-three patients who underwent hemihepatectomy for hepatocellular carcinoma were included. We randomly divided the patients into a development set (n = 265, 75%) and a validation set (n = 88, 25%). Multivariate logistic analysis facilitated identification of independent variables that we incorporated into the artificial neural network model to predict severe posthepatectomy liver failure in the development set and then verified in the validation set.
RESULTS


The morbidity of patients with severe posthepatectomy liver failure in the development and validation sets was 24.9% and 23.9%, respectively. Multivariate analysis revealed that platelet count, prothrombin time, total bilirubin, aspartate aminotransferase, and standardized future liver remnant were all significant predictors of severe posthepatectomy liver failure. Incorporating these factors, the artificial neural network model showed satisfactory area under the receiver operating characteristic curve for the development set of 0.880 (95% confidence interval, 0.836-0.925) and for the validation set of 0.876 (95% confidence interval, 0.801-0.950) in predicting severe posthepatectomy liver failure and achieved well-fitted calibration ability. The predictive performance of the artificial neural network model for severe posthepatectomy liver failure outperformed the traditional logistic regression model and commonly used scoring systems. Moreover, stratification into 3 risk groups highlighted significant differences between the incidences and grades of posthepatectomy liver failure.
CONCLUSION


The artificial neural network model accurately predicted the risk of severe posthepatectomy liver failure in patients with hepatocellular carcinoma who underwent hemihepatectomy. Our artificial neural network model might help surgeons identify intermediate and high-risk patients to facilitate earlier interventions.",2020,The predictive performance of the artificial neural network model for severe posthepatectomy liver failure outperformed the traditional logistic regression model and commonly used scoring systems.,"['Three hundred and fifty-three patients who underwent hemihepatectomy for hepatocellular carcinoma were included', 'patients with hepatocellular carcinoma', 'patients with hepatocellular carcinoma who underwent hemihepatectomy']","['artificial neural network model', 'Artificial neural network model']","['platelet count, prothrombin time, total bilirubin, aspartate aminotransferase, and standardized future liver remnant', 'morbidity of patients with severe posthepatectomy liver failure']","[{'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4087350', 'cui_str': 'Hemihepatectomy'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0870951', 'cui_str': 'Connectionist Models'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}]",353.0,0.0387042,The predictive performance of the artificial neural network model for severe posthepatectomy liver failure outperformed the traditional logistic regression model and commonly used scoring systems.,"[{'ForeName': 'Rong-Yun', 'Initials': 'RY', 'LastName': 'Mai', 'Affiliation': 'Department of Hepatobiliary & Pancreatic Surgery, Guangxi Medical University Cancer Hospital, Nanning, China; Department of Experimental Research, Guangxi Medical University Cancer Hospital, Nanning, China; Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China.'}, {'ForeName': 'Hua-Ze', 'Initials': 'HZ', 'LastName': 'Lu', 'Affiliation': 'Department of Hepatobiliary & Pancreatic Surgery, Guangxi Medical University Cancer Hospital, Nanning, China; Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Bai', 'Affiliation': 'Department of Hepatobiliary & Pancreatic Surgery, Guangxi Medical University Cancer Hospital, Nanning, China; Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Liang', 'Affiliation': 'Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China; Department of First Chemotherapy, Guangxi Medical University Cancer Hospital, Nanning, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China; Department of First Chemotherapy, Guangxi Medical University Cancer Hospital, Nanning, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Hepatobiliary & Pancreatic Surgery, Guangxi Medical University Cancer Hospital, Nanning, China; Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China.'}, {'ForeName': 'Bang-de', 'Initials': 'BD', 'LastName': 'Xiang', 'Affiliation': 'Department of Hepatobiliary & Pancreatic Surgery, Guangxi Medical University Cancer Hospital, Nanning, China; Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China.'}, {'ForeName': 'Guo-Bin', 'Initials': 'GB', 'LastName': 'Wu', 'Affiliation': 'Department of Hepatobiliary & Pancreatic Surgery, Guangxi Medical University Cancer Hospital, Nanning, China; Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China.'}, {'ForeName': 'Le-Qun', 'Initials': 'LQ', 'LastName': 'Li', 'Affiliation': 'Department of Hepatobiliary & Pancreatic Surgery, Guangxi Medical University Cancer Hospital, Nanning, China; Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China.'}, {'ForeName': 'Jia-Zhou', 'Initials': 'JZ', 'LastName': 'Ye', 'Affiliation': 'Department of Hepatobiliary & Pancreatic Surgery, Guangxi Medical University Cancer Hospital, Nanning, China; Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China. Electronic address: yejiazhou2019@163.com.'}]",Surgery,['10.1016/j.surg.2020.06.031']
2488,32793789,"Review of SWOG S1314: Lessons from a Randomized Phase II Study of Co-Expression Extrapolation (COXEN) with Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer.","SWOG1314 is a randomized phase II study of co-expression extrapolation (COXEN) with neoadjuvant chemotherapy for localized, muscle-invasive bladder cancer. COXEN is a biomarker approach in which predictive biomarkers are developed using  in vitro  data, which may then be applied directly into a clinical testing application. Two separate Gene Expression Models (GEMs), one for the Methotrexate, Vinblastine, Doxorubicin, Cisplatin (MVAC) regimen and another for gemcitabine plus cisplatin (GC) were tested in S1314. The lessons learned from the development and operationalization of the S1314 clinical trial are described in detail, which may help to inform the future trials of predictive biomarkers for urothelial carcinoma in the neoadjuvant setting. Specific areas addressed include: The need for broad support from the bladder cancer community, planning for non-evaluable subjects, defining adequate neoadjuvant treatment, defining adequate tissue collection, setting expectations in phase II clinical studies of predictive biomarkers, and maximizing the impact of the samples collected in these studies for broader biomarker development. With a large number of newly available treatments in advanced urothelial carcinoma in the last few years, more investigations of these agents in the neoadjuvant setting is anticipated. There will be a great need for the development of predictive biomarkers in conjunction with the use of these agents in the preoperative setting. Insights from S1314 may provide useful information and lessons learned in this development.",2020,"SWOG1314 is a randomized phase II study of co-expression extrapolation (COXEN) with neoadjuvant chemotherapy for localized, muscle-invasive bladder cancer.","['localized, muscle-invasive bladder cancer']","['Neoadjuvant Chemotherapy', 'Methotrexate, Vinblastine, Doxorubicin, Cisplatin (MVAC) regimen and another for gemcitabine plus cisplatin (GC', 'COXEN', 'neoadjuvant chemotherapy']",[],"[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",[],,0.0288472,"SWOG1314 is a randomized phase II study of co-expression extrapolation (COXEN) with neoadjuvant chemotherapy for localized, muscle-invasive bladder cancer.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Boxley', 'Affiliation': 'University of Colorado, School of Medicine, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Plets', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Flaig', 'Affiliation': 'University of Colorado, School of Medicine, University of Colorado, Aurora, CO, USA.'}]","Bladder cancer (Amsterdam, Netherlands)",['10.3233/BLC-190266']
2489,32793846,Interleukin-6 May Not Affect Bone Resorption Marker CTX or Bone Formation Marker P1NP in Humans.,"Context


Interleukin 6 (IL-6) contributes to bone remodeling in preclinical studies. Clinical trials investigating the role of IL-6 in bone remodeling are limited.
Objective


To investigate if IL-6 regulates bone remodeling in humans.
Design


Plasma concentrations of the bone resorption marker carboxy-terminal type I collagen crosslinks (CTX) and of the bone formation marker procollagen type 1 N-terminal propeptide (P1NP) were measured during a mixed-meal tolerance test (MMTT) in 3 placebo-controlled human studies.
Participants


Five healthy individuals participated in study 1; 52 obese individuals, in study 2; and 10 healthy individuals, in study 3.
Interventions


Study 1 was a single-blinded crossover study consisting of a 1-h infusion of saline (placebo) or the IL-6 receptor antibody tocilizumab followed by an exercise bout. Study 2 was a randomized, double-blinded 12-week exercise training intervention study. Participants received infusions of saline or tocilizumab. Study 3 was a randomized, double-blinded, crossover study consisting of 30 min infusion of saline or IL-6.
Main outcomes measures


Effect of IL-6 on CTX levels.
Results


CTX was significantly ( P  < 0.01) decreased during MMTTs in all 3 studies. Treatment with tocilizumab did not affect exercise or meal induced changes in plasma CTX or P1NP concentrations acutely (study 1) or after a 12-week treatment period (study 2). Exogenous IL-6 had no effect on CTX or P1NP plasma concentrations (study 3).
Conclusions


IL-6 may not regulate bone remodeling in humans.",2020,Treatment with tocilizumab did not affect exercise or meal induced changes in plasma CTX or P1NP concentrations acutely (study 1) or after a 12-week treatment period (study 2).,"['Participants\n\n\nFive healthy individuals participated in study 1; 52 obese individuals, in study 2; and 10 healthy individuals, in study 3', 'humans']","['saline or tocilizumab', 'I collagen crosslinks (CTX) and of the bone formation marker procollagen type 1 N-terminal propeptide (P1NP', 'saline (placebo', 'tocilizumab', 'IL-6', 'IL-6 receptor antibody tocilizumab']","['CTX or P1NP plasma concentrations', 'CTX levels']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]","[{'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",5.0,0.47895,Treatment with tocilizumab did not affect exercise or meal induced changes in plasma CTX or P1NP concentrations acutely (study 1) or after a 12-week treatment period (study 2).,"[{'ForeName': 'Louise L', 'Initials': 'LL', 'LastName': 'Lehrskov', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Kjeldsen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Lyngbæk', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Regitse Højgaard', 'Initials': 'RH', 'LastName': 'Chirstensen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Wedell-Neergaard', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Søderlund', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niklas Rye', 'Initials': 'NR', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Krogh-Madsen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nicolai J', 'Initials': 'NJ', 'LastName': 'Wewer Albrechtsen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Ellingsgaard', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",Journal of the Endocrine Society,['10.1210/jendso/bvaa093']
2490,32793868,Pediatric Ice Pop Administration to Improve Patient Experience Scores.,"Objective


To assess the impact on patient experience scores of giving an ice pop (Popsicle, Good Humor-Breyers, Oakland, CA) to patients in a pediatric emergency department (ED).
Patients and Methods


A prospective two-center trial was conducted at a tertiary academic pediatric ED and a community ED from January 1, 2018, through March 31, 2018. The intervention arm gave an ice pop to all eligible patients 0 to 14 years of age on even-numbered days versus conventional practice on odd-numbered days. Press Ganey top box scores were then compared.
Results


Of 4574 pediatric (0 to 14 years of age) patient visits, patient experience surveys were delivered to 1346 families (29.4%) and 152 were returned (11.3%). Eighty-four surveys were returned for even-numbered day visits and 68 for odd-numbered day visits. There was a significant increase in patient experience scores associated with ice pop administration days for questions that asked about doctor's concern for comfort 70.2% versus 57.4%  (P=. 05), doctor's courtesy 76.2% versus 61.8% ( P =.04), and doctor taking time to listen 72.6% versus 57.4% ( P =.03).
Conclusion


A low-cost intervention resulted in significantly increased patient experience scores in select domains. Popsicle administration was a simple intervention which was easily instituted in both academic and community ED settings. Further study should explore the durability of the effect.",2020,"There was a significant increase in patient experience scores associated with ice pop administration days for questions that asked about doctor's concern for comfort 70.2% versus 57.4%  (P=. 05), doctor's courtesy 76.2% versus 61.8% ( P =.04), and doctor taking time to listen 72.6% versus 57.4% ( P =.03).
","['patients in a pediatric emergency department (ED', 'Patients and Methods\n\n\nA prospective two-center trial was conducted at a tertiary academic pediatric ED and a community ED from January 1, 2018, through March 31, 2018']","['ice pop (Popsicle, Good Humor-Breyers, Oakland, CA']","['patient experience scores', 'doctor taking time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0020746', 'cui_str': 'Ice'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C3853215', 'cui_str': 'Popsicle'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0020168', 'cui_str': 'Humor'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",84.0,0.0333194,"There was a significant increase in patient experience scores associated with ice pop administration days for questions that asked about doctor's concern for comfort 70.2% versus 57.4%  (P=. 05), doctor's courtesy 76.2% versus 61.8% ( P =.04), and doctor taking time to listen 72.6% versus 57.4% ( P =.03).
","[{'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Finn', 'Affiliation': 'Department of Emergency Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Voelkel', 'Affiliation': 'Department of Emergency Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'M Fernanda', 'Initials': 'MF', 'LastName': 'Bellolio', 'Affiliation': 'Department of Emergency Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Molly M', 'Initials': 'MM', 'LastName': 'Jeffery', 'Affiliation': 'Department of Emergency Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Wiswell', 'Affiliation': 'Department of Emergency Medicine, Mayo Clinic Health System, La Crosse, WI.'}]","Mayo Clinic proceedings. Innovations, quality & outcomes",['10.1016/j.mayocpiqo.2020.04.011']
2491,32793869,Using Shared Decision-Making Tools and Patient-Clinician Conversations About Costs.,"Objective


To determine how shared decision-making (SDM) tools used during clinical encounters that raise cost as an issue impact the incidence of cost conversations between patients and clinicians.
Patients and Methods


A randomly selected set of 220 video recordings of clinical encounters were analyzed. Videos were obtained from eight practice-based randomized clinical trials and one quasi-randomized clinical trial (pre- and post-) comparing care with and without SDM tools. The secondary analysis took place in 2018 from trials ran between 2007 and 2015.
Results


Most patient participants were white (85%), educated (38% completed college), middle-aged (mean age 56 years), and female (61%). There were 105 encounters with and 115 without the SDM tool. Encounters with SDM tools were more likely to include both general cost conversations (62% vs 36%, odds ratio [OR]: 9.6; 95% CI: 4 to 26) as well as conversations on medication costs specifically (89% vs 51%,  P =.01). However, clinicians using SDM tools were less likely to address cost issues during the encounter (37% vs 51%,  P =.04). Encounters with patients with less than a college degree were also associated with a higher incidence of cost conversations.
Conclusion


Using SDM tools that raise cost as an issue increased the occurrence of cost conversations but was less likely to address cost issues or offer potential solutions to patients' cost concerns. This result suggests that SDM tools used during the consultation can trigger cost conversations but are insufficient to support them.",2020,"Encounters with SDM tools were more likely to include both general cost conversations (62% vs 36%, odds ratio [OR]: 9.6; 95% CI: 4 to 26) as well as conversations on medication costs specifically (89% vs 51%,  P =.01).","['105 encounters with and 115 without the SDM tool', 'Most patient participants were white (85%), educated (38% completed college), middle-aged (mean age 56 years), and female (61', '2018 from trials ran between 2007 and\xa02015']",[],"['medication costs', 'general cost conversations', 'cost conversations']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",[],"[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.044829,"Encounters with SDM tools were more likely to include both general cost conversations (62% vs 36%, odds ratio [OR]: 9.6; 95% CI: 4 to 26) as well as conversations on medication costs specifically (89% vs 51%,  P =.01).","[{'ForeName': 'Nataly R', 'Initials': 'NR', 'LastName': 'Espinoza Suarez', 'Affiliation': 'Knowledge and Evaluation Research (KER) Unit, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'LaVecchia', 'Affiliation': 'Knowledge and Evaluation Research (KER) Unit, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Oscar J', 'Initials': 'OJ', 'LastName': 'Ponce', 'Affiliation': 'Knowledge and Evaluation Research (KER) Unit, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Fischer', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Wilson', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Celia C', 'Initials': 'CC', 'LastName': 'Kamath', 'Affiliation': 'Knowledge and Evaluation Research (KER) Unit, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'LeBlanc', 'Affiliation': 'Department of Family Medicine and Emergency Medicine, Laval University, Quebec, Canada.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Montori', 'Affiliation': 'Knowledge and Evaluation Research (KER) Unit, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Brito', 'Affiliation': 'Knowledge and Evaluation Research (KER) Unit, Mayo Clinic, Rochester, MN.'}]","Mayo Clinic proceedings. Innovations, quality & outcomes",['10.1016/j.mayocpiqo.2020.04.013']
2492,32794087,Peer and Non-Peer Co-Facilitation of a Health and Wellness Intervention for Adults with Serious Mental Illness.,"Peer specialists, or individuals with lived experience of mental health conditions who support the mental health recovery of others, often work side-by-side with traditional providers (non-peers) in the delivery of treatment groups. The present study aimed to examine group participant and peer provider experiences with peer and non-peer group co-facilitation. Data from a randomized controlled trial of Living Well, a peer and non-peer co-facilitated intervention for medical illness management for adults with serious mental illness, were utilized. A subset of Living Well participants (n = 16) and all peer facilitators (n = 3) completed qualitative interviews. Transcripts were coded and analyzed using a general inductive approach and thematic analysis. The complementary perspectives of the facilitators, teamwork between them, skillful group pacing, and peer facilitator self-disclosure contributed to a warm, respectful, and interactive group atmosphere, which created an environment conducive to social learning. Guidelines for successful co-facilitation emerging from this work are described.",2020,"Data from a randomized controlled trial of Living Well, a peer and non-peer co-facilitated intervention for medical illness management for adults with serious mental illness, were utilized.","['Adults with Serious Mental Illness', 'A subset of Living Well participants (n\u2009=\u200916) and all peer facilitators (n\u2009=\u20093) completed qualitative interviews', 'adults with serious mental illness', 'Peer specialists, or individuals with lived experience of mental health conditions who support the mental health recovery of others, often work side-by-side with traditional providers (non-peers']","['peer and non-peer co-facilitated intervention', 'examine group participant and peer provider experiences with peer and non-peer group co-facilitation', 'Peer and Non-Peer Co-Facilitation of a Health and Wellness Intervention']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C4505046', 'cui_str': 'Mental Health Recovery'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030767', 'cui_str': 'Peer Group'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",[],,0.0301761,"Data from a randomized controlled trial of Living Well, a peer and non-peer co-facilitated intervention for medical illness management for adults with serious mental illness, were utilized.","[{'ForeName': 'Anjana', 'Initials': 'A', 'LastName': 'Muralidharan', 'Affiliation': 'Veterans Affairs (VA) Capitol Health Care Network (VISN 5), Mental Illness, Research, Education, and Clinical Center (MIRECC), Baltimore, MD, USA. anjana.muralidharan2@va.gov.'}, {'ForeName': 'Amanda D', 'Initials': 'AD', 'LastName': 'Peeples', 'Affiliation': 'Veterans Affairs (VA) Capitol Health Care Network (VISN 5), Mental Illness, Research, Education, and Clinical Center (MIRECC), Baltimore, MD, USA.'}, {'ForeName': 'Samantha M', 'Initials': 'SM', 'LastName': 'Hack', 'Affiliation': 'Veterans Affairs (VA) Capitol Health Care Network (VISN 5), Mental Illness, Research, Education, and Clinical Center (MIRECC), Baltimore, MD, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Fortuna', 'Affiliation': 'Geisel School of Medicine, Department of Psychiatry, Dartmouth College, Lebanon, NH, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Klingaman', 'Affiliation': 'Veterans Affairs (VA) Capitol Health Care Network (VISN 5), Mental Illness, Research, Education, and Clinical Center (MIRECC), Baltimore, MD, USA.'}, {'ForeName': 'Naomi F', 'Initials': 'NF', 'LastName': 'Stahl', 'Affiliation': 'Department of Psychology, American University, Washington, DC, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Phalen', 'Affiliation': 'Veterans Affairs (VA) Capitol Health Care Network (VISN 5), Mental Illness, Research, Education, and Clinical Center (MIRECC), Baltimore, MD, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Lucksted', 'Affiliation': 'Veterans Affairs (VA) Capitol Health Care Network (VISN 5), Mental Illness, Research, Education, and Clinical Center (MIRECC), Baltimore, MD, USA.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Goldberg', 'Affiliation': 'Veterans Affairs (VA) Capitol Health Care Network (VISN 5), Mental Illness, Research, Education, and Clinical Center (MIRECC), Baltimore, MD, USA.'}]",The Psychiatric quarterly,['10.1007/s11126-020-09818-2']
2493,32794334,Prognostic value of MRI-determined cervical lymph node size in nasopharyngeal carcinoma.,"OBJECTIVES


To investigate the prognostic value of magnetic resonance imaging (MRI)-determined cervical lymph node (CLN) size in nasopharyngeal carcinoma (NPC).
METHODS


We retrospectively reviewed 2066 patients with NPC treated with intensity-modulated radiotherapy, and randomly divided them into two groups, in a 1:1 ratio. One group was used for training (the training group), and the other one was for internal validation (the validation group). All patients had undergone MRI examination and the maximal axial diameters (MAD) of the axial plane of all positive nodes had been measured and recorded.
RESULTS


Of 683 patients with CLN metastases in the training group (n = 1033), MAD = 4 cm was associated with worse OS (64.7% vs 84.6%, P < .001), DFS (55.9% vs 76.3%, P = .001), and DMFS (67.6% vs 86.1%, P = .001). Multivariate analysis showed that MAD = 4 cm was a significant negative prognostic factor for OS (HR = 2.058; P = .025), DFS (HR = 1.727; P = .049), and DMFS (HR = 2.034; P = .036). When MRI-determined MAD = 4 cm was classified as N3 in the N classification, the OS, DFS, DMFS, and RRFS survival curves were well separated. The OS, DFS, DMFS, and RRFS concordance indexes were not statistically different between the proposed N staging system and the UICC/AJCC staging system in the training group, or between the training group and the validation group (all P = .05).
CONCLUSION


MAD = 4 cm on axial MRI slices can be recommended as a prognostic factor in future versions of the UICC/AJCC NPC staging system.",2020,"The OS, DFS, DMFS, and RRFS concordance indexes were not statistically different between the proposed N staging system and the UICC/AJCC staging system in the training group, or between the training group and the validation group (all P = .05).
","['683 patients with CLN metastases in the training group (n\xa0=\xa01033', '2066 patients with NPC treated with intensity-modulated', 'nasopharyngeal carcinoma', 'nasopharyngeal carcinoma (NPC']","['radiotherapy', 'magnetic resonance imaging (MRI)-determined cervical lymph node (CLN']","['DFS', 'undergone MRI examination and the maximal axial diameters (MAD', 'DMFS', 'OS, DFS, DMFS, and RRFS concordance indexes', 'worse OS', 'OS, DFS, DMFS, and RRFS survival curves']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0588054', 'cui_str': 'Cervical lymph node group'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0588054', 'cui_str': 'Cervical lymph node group'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0254792', 'cui_str': 'ribosome releasing factor'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",2066.0,0.0325976,"The OS, DFS, DMFS, and RRFS concordance indexes were not statistically different between the proposed N staging system and the UICC/AJCC staging system in the training group, or between the training group and the validation group (all P = .05).
","[{'ForeName': 'Cheng-Long', 'Initials': 'CL', 'LastName': 'Huang', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yan-Ping', 'Initials': 'YP', 'LastName': 'Mao', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': 'Imaging Diagnosis and Interventional Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Li-Zhi', 'Initials': 'LZ', 'LastName': 'Liu', 'Affiliation': 'Imaging Diagnosis and Interventional Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ai-Hua', 'Initials': 'AH', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ling-Long', 'Initials': 'LL', 'LastName': 'Tang', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}]",Cancer medicine,['10.1002/cam4.3392']
2494,32794392,Effect of a continuous mechanical polishing protocol and toothbrushing on the surface roughness of acrylic resin teeth.,"PURPOSE


To evaluate in vitro the effect of a continuous mechanical polishing protocol, performed in different periods, on the surface roughness of acrylic resin teeth subjected to toothbrushing (Br).
METHODS


Artificial acrylic teeth (n=30) were randomly divided into three groups according to the polishing protocol and toothbrushing (Br): Br; Br+Pol15 (Br associated with a biweekly polishing); Br+Pol30 (monthly polishing). Br group was subjected to a total of 89,000 brushing cycles. Polishing was performed by applying aluminum oxide paste to the specimens with a felt wheel coupled to an electric motor (5 seconds, 3,000 rpm) after each 741 and 1482 brushing cycles for Br+Pol15 and Br+Pol30 groups, respectively. A contact profilometer and an analytical balance were used to measure surface roughness and mass changes before (T0) and after 1, 2, 3, and 5 years (T4) of simulated toothbrushing. Scanning electron microscopy (SEM) images were obtained. Differences among groups were tested by means of two-way ANOVA/Bonferroni tests (P= 0.05).
RESULTS


Toothbrushing gradually increased surface roughness [T0 - 0.16 (0.01); T4 - 0.30 (0.10); P< 0.001]. The tested polishing promoted a significant roughness reduction (P< 0.001) for both biweekly [T4 - 0.09 (0.01) ] and monthly [T4 - 0.13 (0.02) ] regimes, and it did not influence the mass alterations caused by toothbrushing. SEM showed a smoother aspect of the material surface subjected to biweekly polishing with less defects caused by brushing abrasiveness.
CLINICAL SIGNIFICANCE


In order to reduce the effects of various deleterious factors on the properties of acrylic resin for removable prostheses during their period of use, a frequent mechanical polishing protocol could increase clinical performance and extend the lifespan of these appliances. Furthermore, a polishing protocol by means of a simple technique could be employed by patients in a home environment.",2020,"SEM showed a smoother aspect of the material surface subjected to biweekly polishing with less defects caused by brushing abrasiveness.
","['Artificial acrylic teeth', 'n=30', 'acrylic resin teeth']","['aluminum oxide paste', 'continuous mechanical polishing protocol', 'polishing protocol and toothbrushing (Br', 'continuous mechanical polishing protocol and toothbrushing']","['surface roughness', 'roughness reduction']","[{'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0440181', 'cui_str': 'Acrylic dental material'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0001222', 'cui_str': 'Acrylic Resins'}]","[{'cui': 'C1253849', 'cui_str': 'Aluminum Oxide Paste'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",30.0,0.0157851,"SEM showed a smoother aspect of the material surface subjected to biweekly polishing with less defects caused by brushing abrasiveness.
","[{'ForeName': 'Giovanna G', 'Initials': 'GG', 'LastName': 'Guimarães', 'Affiliation': 'Private practice.'}, {'ForeName': 'Marina F', 'Initials': 'MF', 'LastName': 'Sarte', 'Affiliation': 'Private practice.'}, {'ForeName': 'Joel O', 'Initials': 'JO', 'LastName': 'Barreto', 'Affiliation': 'Graduate student, Department of Restorative Dentistry, Federal University of Ceará, Fortaleza, Brazil.'}, {'ForeName': 'Karina M', 'Initials': 'KM', 'LastName': 'de Freitas-Pontes', 'Affiliation': 'Department of Restorative Dentistry, Federal University of Ceará, Fortaleza, Brazil.'}, {'ForeName': 'Romulo R', 'Initials': 'RR', 'LastName': 'Regis', 'Affiliation': 'Department of Restorative Dentistry, Federal University of Ceará, Fortaleza, CE, Brazil, romuloregis@hotmail.com.'}]",American journal of dentistry,[]
2495,32794396,Dentin moisture does not influence postoperative sensitivity in posterior restorations: A double-blind randomized clinical trial.,"PURPOSE


This double-blind, randomized clinical trial evaluated the influence of dentin moisture on postoperative sensitivity (POS) in posterior restorations using a simplified etch-and-rinse adhesive, until 12 months of clinical service.
METHODS


90 restorations were inserted in 45 patients to treat carious lesions or to replace existing posterior restorations with a depth ≥ 3 mm. After cavity preparation, the simplified etch-and-rinse adhesive (Adper Single Bond 2) was applied on dry or wet dentin followed by a bulk-fill resin composite (Filtek Bulk Fill) under rubber dam isolation. The patient's spontaneous and stimulated POS was evaluated at baseline and after 7 days, 6 months, and 12 months of clinical evaluation. The secondary parameters (marginal discoloration, marginal adaptation, fracture and recurrence of caries) were evaluated by World Dental Federation (FDI) criteria after 7 days, 6 and 12 months of clinical evaluation.
RESULTS


No significant spontaneous and stimulated POS was observed when dry and wet dentin were compared (P> 0.05). A significant and higher risk of spontaneous POS (18.6%; 95% CI 9.7 to 32.6) occurred up to 48 hours after restoration placement for both groups when compared to all evaluation times (P< 0.03). However, the intensity of POS was mild at up to 48 hours with a difference between the dry and wet dentin groups (P> 0.79). When secondary parameters were evaluated, no significant difference between the groups were observed (P> 0.05).
CLINICAL SIGNIFICANCE


The moisture level of the dentin substrate in posterior restorations does not influence POS in bulk-fill resin composite posterior restorations when associated with an etch-and-rinse ethanol-based adhesive system.",2020,"However, the intensity of POS was mild at up to 48 hours with a difference between the dry and wet dentin groups (P> 0.79).","['90 restorations were inserted in 45 patients to treat carious lesions or to replace existing posterior restorations with a depth ≥ 3 mm', 'posterior restorations']","['dentin moisture', 'Dentin moisture']","['intensity of POS', 'spontaneous and stimulated POS', ""patient's spontaneous and stimulated POS"", 'postoperative sensitivity (POS', 'higher risk of spontaneous POS', 'secondary parameters (marginal discoloration, marginal adaptation, fracture and recurrence of caries']","[{'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]",90.0,0.306561,"However, the intensity of POS was mild at up to 48 hours with a difference between the dry and wet dentin groups (P> 0.79).","[{'ForeName': 'Andrea S', 'Initials': 'AS', 'LastName': 'Castro', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Ponta Grossa, PR, Brazil.'}, {'ForeName': 'Bianca M', 'Initials': 'BM', 'LastName': 'Maran', 'Affiliation': 'Postgraduate Program in Dentistry, School of Dentistry, University of North Paraná, Londrina, Paraná, Brazil.'}, {'ForeName': 'Mario F', 'Initials': 'MF', 'LastName': 'Gutiérrez', 'Affiliation': 'Faculty of Dentistry, University of the Andes, Santiago, Chile.'}, {'ForeName': 'Eveline C', 'Initials': 'EC', 'LastName': 'Martini', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Ponta Grossa, PR, Brazil.'}, {'ForeName': 'Fabiana Ds', 'Initials': 'FD', 'LastName': 'Dreweck', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Ponta Grossa, PR, Brazil.'}, {'ForeName': 'Luján', 'Initials': 'L', 'LastName': 'Mendez-Bauer', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Ponta Grossa, PR, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Reis', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Ponta Grossa, PR, Brazil.'}, {'ForeName': 'Alessandro D', 'Initials': 'AD', 'LastName': 'Loguercio', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Ponta Grossa, PR, Brazil, aloguercio@hotmail.com.'}]",American journal of dentistry,[]
2496,32794398,The relative clinical efficacy of three 0.454% stannous fluoride dentifrices for the treatment of gingivitis over 3 months.,"PURPOSE


To assess the safety and efficacy of three stannous fluoride (SnF2) dentifrices in the reduction of gingivitis versus a negative control dentifrice.
METHODS


This was a randomized, controlled, double-blind, four-treatment parallel group study. 120 healthy adult volunteers with established gingivitis were enrolled and randomly assigned to one of four dentifrice treatment groups (30/group): 0.454% SnF2 + citrate dentifrice A; 0.454% SnF2 + sodium hexametaphosphate dentifrice B; 0.454% SnF2 + pyrophosphate dentifrice C; or 0.76% sodium monofluorophosphate negative control group. Subjects brushed with their assigned dentifrice and an assigned regular manual toothbrush (Oral-B Indicator) for 1 minute twice daily for 12 weeks. Number of gingival bleeding sites and Löe-Silness Gingival Index (LSGI) scores were assessed at baseline and at Weeks 2, 4 and 12.
RESULTS


120 subjects were enrolled and 112 completed the trial. Subjects had an average age (SD) of 39.31 (14.5) years; 67% of subjects were female. Overall baseline means (SD) were 81.2 (25.6) for number of bleeding sites and 1.51 (0.197) for mean LSGI score. Baseline disease levels were balanced across all treatment groups. At Week 2, SnF2 dentifrices A and B demonstrated a significant reduction in gingival bleeding sites versus the negative control; however, SnF2 dentifrice C was not significantly different from the negative control (P= 0.15). At Weeks 4 and 12, all SnF2 dentifrices demonstrated a significant gingival bleeding site reduction versus the negative control (P< 0.001). At Weeks 2, 4 and 12, the SnF2 dentifrices were rank ordered dentifrice A > dentifrice B > dentifrice C for reduction in gingival bleeding sites (P< 0.001). The same trends were seen for LSGI scores.
CLINICAL SIGNIFICANCE


In this 12-week clinical study, all 0.454% SnF2 dentifrices delivered statistically significant reductions in the number of gingival bleeding sites relative to the negative control. Importantly, statistically significant efficacy differences were observed among the three 0.454% SnF2 dentifrices, demonstrating the important role that differences in formulation have on clinical efficacy.",2020,A > dentifrice B > dentifrice C for reduction in gingival bleeding sites (P< 0.001).,"['Subjects had an average age (SD) of 39.31 (14.5) years; 67% of subjects were female', '120 subjects were enrolled and 112 completed the trial', '120 healthy adult volunteers with established gingivitis']","['stannous fluoride (SnF2) dentifrices', 'stannous fluoride dentifrices', 'SnF2 + pyrophosphate dentifrice C', 'SnF2 dentifrices were rank ordered dentifrice', 'sodium monofluorophosphate negative control', 'dentifrice B > dentifrice C', 'SnF2 + citrate dentifrice A; 0.454% SnF2 + sodium hexametaphosphate dentifrice B']","['Baseline disease levels', 'LSGI scores', 'number of gingival bleeding sites', 'gingival bleeding sites', 'safety and efficacy', 'gingival bleeding site reduction', 'Number of gingival bleeding sites and Löe-Silness Gingival Index (LSGI) scores', 'Overall baseline means (SD']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0443211', 'cui_str': 'Established'}]","[{'cui': 'C0038143', 'cui_str': 'Stannous Fluoride'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0034320', 'cui_str': 'Pyrophosphate'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0142890', 'cui_str': 'sodium monofluorophosphate'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008857', 'cui_str': 'Citrates'}, {'cui': 'C0074759', 'cui_str': 'sodium polymetaphosphate'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0017565', 'cui_str': 'Bleeding gums'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",120.0,0.0258565,A > dentifrice B > dentifrice C for reduction in gingival bleeding sites (P< 0.001).,"[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'He', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, USA, he.t@pg.com.'}, {'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Nachnani', 'Affiliation': 'University Health Resources Group, Whittier, CA, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'University Health Resources Group, Whittier, CA, USA.'}, {'ForeName': 'Yuanshu', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Grender', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, USA.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Farrell', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sagel', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, USA.'}, {'ForeName': 'Aaron R', 'Initials': 'AR', 'LastName': 'Biesbrock', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, USA.'}]",American journal of dentistry,[]
2497,32794483,"Serum vitamin D, vitamin D binding protein levels and leukocyte vitamin D receptor gene expression in patients with ischaemic stroke.","Objective


To investigate the possible contributions of serum 25 hydroxyvitamin D and vitamin D binding protein levels along with leukocyte vitamin D receptor gene expression in patients with ischaemic stroke.
METHODS


The randomised controlled single-blind study was conducted at the Mayo Hospital, Lahore, Pakistan, from September 2015 to September 2017, and comprised patients aged 40-75 years with Arbeitsgemeinschaft für Osteosynthesefragen type A2 and A3 per trochanteric fracture. The patients randomised into two equal groups. In Group A, patients were treated by closed reduction and internal fixation with dynamic hip screw, while those in Group B were treated by closed reduction and internal fixation by proximal femoral nail. Follow-up was done at 2nd, 6th and 12th weeks, and at 6th, 9th and 12th month post-operatively. Variables evaluated were frequency of union, surgical time, approximate amount of blood loss and complications. The functional assessment was done by using Harris hip score. SPSS 20 was used for data analysis.
RESULTS


Of the 90 subjects, 51 (56.6%) were cases with a mean age of 65.2±14.3 years, and 39 (43.3%) were controls with a mean age of 61.1±16.7 years. There was no difference between the groups with respect to vitamin D deficiency, serum vitamin D binding protein levels and leukocyte vitamin D receptor gene expressions (p>0.05). A negative correlation was found between 25-hydroxyvitamin D levels and the severity of ischaemic stroke (p=0.0342).
Conclusion


There was a correlation between serum 25-hydroxyvitamin D levels and severity of ischaemic stroke as assessed by the National Institutes of Health Stroke Scale.",2020,"There was no difference between the groups with respect to vitamin D deficiency, serum vitamin D binding protein levels and leukocyte vitamin D receptor gene expressions (p>0.05).","['Mayo Hospital, Lahore, Pakistan, from September 2015 to September 2017, and comprised patients aged 40-75 years with Arbeitsgemeinschaft für Osteosynthesefragen type A2 and A3 per trochanteric fracture', 'patients with ischaemic stroke', 'Of the 90 subjects, 51 (56.6%) were cases with a mean age of 65.2±14.3 years, and 39 (43.3%) were controls with a mean age of 61.1±16.7 years']","['closed reduction and internal fixation by proximal femoral nail', 'closed reduction and internal fixation with dynamic hip screw']","['serum 25-hydroxyvitamin D levels and severity of ischaemic stroke', '25-hydroxyvitamin D levels and the severity of ischaemic stroke', 'vitamin D deficiency, serum vitamin D binding protein levels and leukocyte vitamin D receptor gene expressions', 'Serum vitamin D, vitamin D binding protein levels and leukocyte vitamin D receptor gene expression', 'frequency of union, surgical time, approximate amount of blood loss and complications']","[{'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0162387', 'cui_str': 'Trochanteric Fractures'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0242210', 'cui_str': 'Binding protein'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0108082', 'cui_str': 'Vitamin D3 Receptor'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0042872', 'cui_str': 'GC globulin'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.024754,"There was no difference between the groups with respect to vitamin D deficiency, serum vitamin D binding protein levels and leukocyte vitamin D receptor gene expressions (p>0.05).","[{'ForeName': 'Senol', 'Initials': 'S', 'LastName': 'Arslan', 'Affiliation': 'Department of Emergency Medicine, Erzurum Training and Research Hospital, Erzurum, Turkey.'}, {'ForeName': 'Elif Funda', 'Initials': 'EF', 'LastName': 'Sener', 'Affiliation': 'Department of Medical Biology, Erciyes University, Genom and Stem Cell Center, Kayseri, Turkey.'}, {'ForeName': 'Nahide Ekici', 'Initials': 'NE', 'LastName': 'Gunay', 'Affiliation': 'Department of Clinical Biochemistry, Kayseri Training and Research Hospital, Kayseri, Turkey.'}, {'ForeName': 'Seniz', 'Initials': 'S', 'LastName': 'Demiryurek', 'Affiliation': 'Department of Physiology, Gaziantep University, Gaziantep, Turkey.'}, {'ForeName': 'Uhut Rafi', 'Initials': 'UR', 'LastName': 'Gulderen', 'Affiliation': 'Department of Emergency Medicine, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Tuba', 'Initials': 'T', 'LastName': 'Topaloglu', 'Affiliation': 'Department of Medical Biology, Erciyes University, Genom and Stem Cell Center, Kayseri, Turkey.'}, {'ForeName': 'Nurullah', 'Initials': 'N', 'LastName': 'Gunay', 'Affiliation': 'Department of Emergency Medicine, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Nurullah', 'Initials': 'N', 'LastName': 'Gunay', 'Affiliation': 'Department of Emergency Medicine, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Abdullah Tuncay', 'Initials': 'AT', 'LastName': 'Demiryurek', 'Affiliation': 'Department of Medical Pharmacology, Gaziantep University, Gaziantep, Turkey.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.987']
2498,32794567,Tofacitinib in Patients with Ulcerative Colitis: Inflammatory Bowel Disease Questionnaire Items in Phase 3 Randomized Controlled Induction Studies.,"BACKGROUND


Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We examined the effect of tofacitinib induction treatment on Inflammatory Bowel Disease Questionnaire (IBDQ) items in adults with moderate to severe UC.
METHODS


Data were pooled from the randomized, 8‑week, double-blind, phase 3 OCTAVE Induction 1 and 2 studies. The IBDQ was self-administered by patients at baseline, week 4, and week 8, with higher scores indicating better health-related quality of life (HRQoL). Change from baseline in IBDQ items was analyzed for 10 mg of tofacitinib twice daily (BID) vs placebo using a linear mixed-effects model, with no multiplicity adjustment performed. Effect sizes were calculated. Subgroup analyses by tumor necrosis factor inhibitor (TNFi) experience were performed.
RESULTS


Significant improvements (nominal P < 0.05) were observed in all IBDQ items with 10 mg of tofacitinib BID vs placebo at weeks 4 and 8. For the overall population, the largest treatment differences across all items were reported for ""bowel movements been loose"" at weeks 4 and 8, and ""problem with rectal bleeding"" at week 8 (mean treatment differences all 1.1; both in bowel symptoms domain). These items also showed the largest effect sizes. Treatment benefits were generally slightly numerically higher in TNFi-experienced vs TNFi-naïve patients.
CONCLUSIONS


Tofacitinib induction therapy improved all IBDQ items vs placebo in patients with UC, reflecting improvements in HRQoL, with greatest benefits reported in bowel symptoms domain items (Funded by Pfizer Inc; OCTAVE Induction 1 and OCTAVE Induction 2; ClinicalTrials.gov, NCT01465763 and NCT01458951, respectively).",2020,"RESULTS


Significant improvements (nominal P < 0.05) were observed in all IBDQ items with 10 mg of tofacitinib BID vs placebo at weeks 4 and 8.","['Patients with Ulcerative Colitis', 'adults with moderate to severe UC', 'patients with UC']","['tofacitinib induction treatment', 'Tofacitinib', 'placebo']","['health-related quality of life (HRQoL', 'Inflammatory Bowel Disease Questionnaire (IBDQ) items', 'IBDQ items']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.238663,"RESULTS


Significant improvements (nominal P < 0.05) were observed in all IBDQ items with 10 mg of tofacitinib BID vs placebo at weeks 4 and 8.","[{'ForeName': 'Marla C', 'Initials': 'MC', 'LastName': 'Dubinsky', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'DiBonaventura', 'Affiliation': 'Pfizer Inc., New York, New York, USA.'}, {'ForeName': 'Haiyun', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': 'Pfizer Inc., Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Bushmakin', 'Affiliation': 'Pfizer Inc., Groton, Connecticut, USA.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Cappelleri', 'Affiliation': 'Pfizer Inc., Groton, Connecticut, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Maller', 'Affiliation': 'Pfizer Inc., Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Thorpe', 'Affiliation': 'Pfizer Inc., Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Salese', 'Affiliation': 'Pfizer Inc., Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Panés', 'Affiliation': 'Inflammatory Bowel Diseases Unit, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.'}]",Inflammatory bowel diseases,['10.1093/ibd/izaa193']
2499,32794582,"Oral 3-hydroxybutyrate ingestion decreases endogenous glucose production, lipolysis, and hormone-sensitive lipase phosphorylation in adipose tissue in men: a human randomized, controlled, crossover trial.","AIMS


To test whether oral administration of D/L-3-hydroxybutyrate as a sodium salt inhibits lipolysis and intracellular lipid signalling, in particular, hormone-sensitive lipase, and whether D/L-3-hydroxybutyrate alters endogenous glucose production.
METHODS


We studied six young men in a randomized, controlled, crossover study after ingestion of Na-D/L-3-hydroxybutyrate (hyperketotic condition) or saline (placebo control). We quantified lipolysis and endogenous glucose production using [9,10- 3  H]-palmitate and [3-3H]glucose tracers, and adipose tissue biopsies were collected to investigate key lipolytic enzymes.
RESULTS


After ingestion, D/L-3-hydroxybutyrate increased >2.5 mmol/l, free fatty acid concentrations decreased by >70%, and palmitate rate of appearance was halved. Protein kinase A phosphorylation of perilipin was reduced and hormone-sensitive lipase 660 phosphorylation in adipose tissue biopsies was 70-80% decreased in the hyperketotic condition and unchanged in the control. Compared to the control, endogenous glucose production was reduced by close to 20% (P<0.05) after 3-hydroxybutyrate ingestion.
CONCLUSION


We conclude that oral D/L-Na-3-hydroxybutyrate increases D/L-3-hydroxybutyrate concentrations within half an hour, decreases free fatty acid concentrations, lowers lipolysis and endogenous glucose production, and dephosphorylates hormone-sensitive lipase. Collectively these phenomena may be viewed as an orchestrated feedback loop, controlling endogenous glucose production, lipolysis and ketogenesis. Such effects would be beneficial in insulin-resistant states.",2020,"Compared to the control, endogenous glucose production was reduced by close to 20% (P<0.05) after 3-hydroxybutyrate ingestion.
","['adipose tissue in men', 'six young men']","['ingestion of Na-D/L-3-hydroxybutyrate (hyperketotic condition) or saline (placebo control', 'Oral 3-hydroxybutyrate ingestion', 'oral D/L-Na-3-hydroxybutyrate', 'D/L-3-hydroxybutyrate']","['palmitate rate of appearance', 'endogenous glucose production', 'D/L-3-hydroxybutyrate concentrations', 'free fatty acid concentrations, lowers lipolysis and endogenous glucose production, and dephosphorylates hormone-sensitive lipase', 'free fatty acid concentrations', 'adipose tissue biopsies']","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0604267', 'cui_str': 'L-3'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0106006', 'cui_str': '3-hydroxybutyrate'}]","[{'cui': 'C0030233', 'cui_str': 'Hexadecanoates'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0604267', 'cui_str': 'L-3'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0023796', 'cui_str': 'Lipolysis'}, {'cui': 'C0008385', 'cui_str': 'Cholesterol esterase'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]",6.0,0.0523582,"Compared to the control, endogenous glucose production was reduced by close to 20% (P<0.05) after 3-hydroxybutyrate ingestion.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Svart', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Denmark.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Rittig', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Denmark.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Pedersen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Denmark.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Jessen', 'Affiliation': 'Clinical Pharmacology, Aarhus University Hospital, Denmark.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Møller', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Denmark.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14385']
2500,32794658,Application of three dimensional (3D) curved multi-planar reconstruction images in 3D printing mold assisted eyebrow arch keyhole microsurgery.,"OBJECTIVE


The application of multi-planar reconstruction of three dimensional (3D) curved surface in microsurgery of 3D printing mold assisted eyebrow arch keyhole approach was studied.
METHODS


Eighty patients with intracranial aneurysms who underwent treatment at our hospital were enrolled. The patients were divided into two groups: the traditional eyebrow keyhole approach microsurgery group (38 cases in the conventional treatment group) and the three-dimensional curved surface multi-plane reconstruction image combined with 3D printing technology assisted eyebrow keyhole approach microsurgery group (42 cases in the 3D printing assisted treatment group). The Hunt-Hess classification was used to make a preliminary estimation of the patient's condition. The 3D curved multi-planar reconstruction method was used to assist the surgical plan; CT scan was used to establish a 3D printing mold, and the patient's condition and surgical plan were accurately analyzed before surgery. The operative time and the size of the incision area were recorded; postoperative GOS score and postoperative complications were statistically investigated.
RESULTS


The 3D printing assisted treatment group (70.13 ± 15.56), (411.26 ± 10.38) mm 2  , the operative time and incision area were significantly shorter than the conventional treatment group (120.35 ± 20.46), (663.55 ± 13.54) mm 2  , p < .05); the GOS score showed that the 3D printing-assisted treatment group was significantly higher than the conventional treatment group (p < .05). The postoperative complication rate was significantly lower in the 3D print-assisted treatment group (9.52%) than in the conventional treatment group (47.36%, p < .05); the cure of intracranial aneurysms in the 3D printing assisted treatment group was more thorough than that in the conventional treatment group, and the difference was significant (p < .05).
CONCLUSION


Compared with the conventional eyebrow arch-hole approach microsurgery, the 3D surface multi-planar reconstruction image combined 3D printing assisted technology was safer and more effective, and the postoperative recovery was better and the incidence of complications was lower.",2020,"The postoperative complication rate was significantly lower in the 3D print-assisted treatment group (9.52%) than in the conventional treatment group (47.36%, p < .05); the cure of intracranial aneurysms in the 3D printing assisted treatment group was more thorough than that in the conventional treatment group, and the difference was significant (p < .05).
",['Eighty patients with intracranial aneurysms who underwent treatment at our hospital were enrolled'],"['three dimensional (3D) curved multi-planar reconstruction images', 'traditional eyebrow keyhole approach microsurgery group (38 cases in the conventional treatment group) and the three-dimensional curved surface multi-plane reconstruction image combined with 3D printing technology assisted eyebrow keyhole approach microsurgery group']","['operative time and incision area', 'postoperative complication rate', 'GOS score', 'operative time and the size of the incision area', 'postoperative GOS score and postoperative complications', 'cure of intracranial aneurysms']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007766', 'cui_str': 'Intracranial aneurysm'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0205133', 'cui_str': 'Bent'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0015420', 'cui_str': 'Eyebrow structure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0026035', 'cui_str': 'Microsurgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0007766', 'cui_str': 'Intracranial aneurysm'}]",80.0,0.0190235,"The postoperative complication rate was significantly lower in the 3D print-assisted treatment group (9.52%) than in the conventional treatment group (47.36%, p < .05); the cure of intracranial aneurysms in the 3D printing assisted treatment group was more thorough than that in the conventional treatment group, and the difference was significant (p < .05).
","[{'ForeName': 'Sheng-Jun', 'Initials': 'SJ', 'LastName': 'Li', 'Affiliation': 'Department of Neurosurgery, Linyi Central Hospital, Linyi, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Emergency, Linyi Central Hospital, Linyi, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Neurosurgery, Linyi Central Hospital, Linyi, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'Department of Neurosurgery, Linyi Central Hospital, Linyi, China.'}]",Brain and behavior,['10.1002/brb3.1785']
2501,32794673,[Optimized preparation method of leukocytes-rich platelet-rich plasma by varying conditions during centrifugation].,"Objective


To identify a more popularized preparation protocol of leukocytes-rich platelet-rich plasma (L-PRP) for higher tolerance rate.
Methods


The peripheral blood samples of 76 volunteers (45.0 mL/case) were mixed with 5 mL sodium citrate injection for blood transfusion, and L-PRP was prepared by twice centrifugations. All blood samples were divided into three groups according to the parameters of twice centrifugation: experimental group A (12 cases, 400×  g , 10 minutes for the first time and 1 100×  g , 10 minutes for the second time), experimental group B (27 cases, 800×  g , 10 minutes for the first time and 1 100×  g , 10 minutes for the second time), and control group (37 cases, 1 360×  g , 10 minutes for the first time and 1 360×  g , 10 minutes for the second time). The platelet recovery rate and platelet and leukocyte enrichment coefficient of L-PRP in each group were calculated and compared.
Results


After removal of abnormal blood samples (platelet recovery rate was more than 100% or white thrombus), the remaining 55 cases were included in the statistical analysis, including 10 cases in experimental group A, 21 cases in experimental group B, and 24 cases in control group. The platelet enrichment coefficient and platelet recovery rate of experimental group B were significantly higher than those of experimental group A and control group (  P <0.05); there was no significant difference between experimental group A and control group (  P >0.05). There was no significant difference in leukocyte enrichment coefficient between experimental groups A, B, and control group (  P >0.05).
Conclusion


The preparation quality of PRP is affected by various factors, including centrifugal force, centrifugal time, temperature, and operation process,  etc . Twice centrifugation (800×  g , 10 minutes for the first time and 1 100×  g , 10 minutes for the second time) is an ideal and feasible centrifugation scheme, which can obtain satisfactory platelet recovery rate and enrichment coefficient with thicker buffy coat, which can reduce the fine operation requirements for operators, improve the fault tolerance rate and generalization.",2020,The platelet enrichment coefficient and platelet recovery rate of experimental group B were significantly higher than those of experimental group A and control group (  P <0.05); there was no significant difference between experimental group A and control group (  P >0.05).,['76 volunteers (45.0 mL/case'],"['leukocytes-rich platelet-rich plasma (L-PRP', 'Twice centrifugation']","['abnormal blood samples (platelet recovery rate', 'leukocyte enrichment coefficient', 'platelet enrichment coefficient and platelet recovery rate', 'platelet recovery rate and platelet and leukocyte enrichment coefficient of L-PRP']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0007703', 'cui_str': 'Centrifugation'}]","[{'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}]",,0.0113833,The platelet enrichment coefficient and platelet recovery rate of experimental group B were significantly higher than those of experimental group A and control group (  P <0.05); there was no significant difference between experimental group A and control group (  P >0.05).,"[{'ForeName': 'Zhaoyuan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, P.R.China.""}, {'ForeName': 'Yuxuan', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': '.'}, {'ForeName': 'Changqing', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, P.R.China.""}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Yuan', 'Affiliation': ""Department of Orthopaedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, P.R.China.""}]",Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery,['10.7507/1002-1892.201911054']
2502,32792317,Acute physiological responses with varying load or time under tension during a squat exercise: A randomized cross-over design.,"OBJECTIVES


Despite advancements in resistance training (RT) methods, the acute metabolic and neuromuscular responses to time under tension (TUT) and load remains poorly understood. The aim of the present study was to investigate how TUT or resistance load impact muscular activation and blood lactate during an RT session.
DESIGN


A randomized cross-over design.
METHODS


Participants performed a squat exercise in three different conditions: baseline protocol (B PRO ; three sets of eight repetitions with four second repetitions at 60% of 1RM) long duration protocol (LD PRO : six second repetitions) and high load protocol (HL PRO : 70% 1RM).
RESULTS


Muscular activation of the vastus lateralis and biceps femoris, and blood lactate were assessed. Blood lactate was ∼19% and ∼26% higher after set one and three in LD PRO  compared to B PRO  (P≤0.011) and ∼17% higher for LD PRO  compared to HL PRO  (P=0.002). Additionally, blood lactate was ∼17% higher for HL PRO  compared to B PRO  after the third set of exercise (P=0.003). Vastus lateralis activation was ∼10% higher for HL PRO  compared to B PRO  and LD PRO  for sets one and two. Biceps femoris activation was ∼17% higher for HL PRO  compared to B PRO  for set one (P= 0.023) while for set two HL PRO  was greater than B PRO  and LD PRO  (∼19% and ∼14%, respectively; P≤0.007).
CONCLUSIONS


Squatting with higher TUT caused a greater impact on the metabolic responses than lower TUT or higher loads, whereas an increase in training load resulted in greater muscle activation than higher TUT or lower training load.",2020,Blood lactate was ∼19% and ∼26% higher after set one and three in LD PRO  compared to B PRO  ,['Participants performed a'],"['squat exercise', 'varying load or time under tension during a squat exercise', '1RM) long duration protocol (LD PRO : six second repetitions) and high load protocol (HL PRO : 70% 1RM']","['Blood lactate', 'Biceps femoris activation', 'blood lactate', 'muscle activation', 'metabolic responses', 'Muscular activation of the vastus lateralis and biceps femoris, and blood lactate', 'Vastus lateralis activation', 'TUT or resistance load impact muscular activation and blood lactate']","[{'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0224449', 'cui_str': 'Biceps femoris muscle structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",,0.0295057,Blood lactate was ∼19% and ∼26% higher after set one and three in LD PRO  compared to B PRO  ,"[{'ForeName': 'Erica F F', 'Initials': 'EFF', 'LastName': 'Corradi', 'Affiliation': 'Weight Training Laboratory, School of Physical Education, Physiotherapy and Occupational Therapy, Federal University of Minas Gerais, Brazil.'}, {'ForeName': 'Marcel Bahia', 'Initials': 'MB', 'LastName': 'Lanza', 'Affiliation': 'Weight Training Laboratory, School of Physical Education, Physiotherapy and Occupational Therapy, Federal University of Minas Gerais, Brazil; Department of Physical Therapy and Rehabilitation, School of Medicine, University of Maryland, Baltimore, United States. Electronic address: Marcel.lanza@gmail.com.'}, {'ForeName': 'Lucas Túlio', 'Initials': 'LT', 'LastName': 'Lacerda', 'Affiliation': 'Weight Training Laboratory, School of Physical Education, Physiotherapy and Occupational Therapy, Federal University of Minas Gerais, Brazil; Departament of Physical Education Pontifical Catholic University of Minas Gerais, Brazil; Department of Physical Education and Sports, Technological Education Federal Center of Minas Gerais, Brazil.'}, {'ForeName': 'Justin W', 'Initials': 'JW', 'LastName': 'Andrushko', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Canada.'}, {'ForeName': 'Hugo C', 'Initials': 'HC', 'LastName': 'Martins-Costa', 'Affiliation': 'Weight Training Laboratory, School of Physical Education, Physiotherapy and Occupational Therapy, Federal University of Minas Gerais, Brazil; Departament of Physical Education Pontifical Catholic University of Minas Gerais, Brazil.'}, {'ForeName': 'Rodrigo C R', 'Initials': 'RCR', 'LastName': 'Diniz', 'Affiliation': 'Weight Training Laboratory, School of Physical Education, Physiotherapy and Occupational Therapy, Federal University of Minas Gerais, Brazil.'}, {'ForeName': 'Fernando Vitor', 'Initials': 'FV', 'LastName': 'Lima', 'Affiliation': 'Weight Training Laboratory, School of Physical Education, Physiotherapy and Occupational Therapy, Federal University of Minas Gerais, Brazil.'}, {'ForeName': 'Mauro Heleno', 'Initials': 'MH', 'LastName': 'Chagas', 'Affiliation': 'Weight Training Laboratory, School of Physical Education, Physiotherapy and Occupational Therapy, Federal University of Minas Gerais, Brazil.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.07.015']
2503,32792320,Effect of Short-Term L-Thyroxine Therapy on Left Ventricular Mechanics in Idiopathic Dilated Cardiomyopathy.,"OBJECTIVE


Previous experimental studies have provided evidence of notable changes in thyroid hormone signaling that corresponds to alterations in myocardial function in animal models of heart failure (HF). The present study further explores whether oral thyroid hormone treatment can change left ventricular (LV) mechanics and functional status in patients with idiopathic dilated cardiomyopathy (IDCM) or not.
METHODS


Sixty IDCM patients who were receiving conventional HF treatment were randomized to oral L-thyroxine (n = 40) or placebo (n = 20) for 3 months. Fifty-two (86.7%) of all IDCM patients were symptomatic, their mean age was 41 ± 12 years, and their ejection fraction was 32% ± 7%. At baseline, the two groups were comparable in clinical and echocardiographic variables. Vector velocity imaging was utilized to assess LV mechanics. Myocardial longitudinal peak systolic strain, systolic strain rate, early and late diastolic strain rate, circumferential strain, LV dyssynchrony, plasma tri-iodothyronine, thyroxine, and thyroid stimulating hormone levels were measured at baseline and 3 months after treatment.
RESULTS


All patients receiving L-thyroxine significantly improved in functional status (New York Heart Association class; P < .001) and echocardiographic parameters including end-diastolic diameter (P < .001), end-systolic diameter (P < .001), mitral regurgitation severity reduction (P < .001), and increased ejection fraction (P < .001). Left ventricular mechanics showed marked improvement at segmental and global levels of both longitudinal and circumferential myocardial strain (P < .005) when compared with placebo group.
CONCLUSIONS


Short-term L-thyroxine therapy is well tolerated in IDCM patients. It improves cardiac mechanics and functional status, which might support the potential role of synthetic thyroid hormones in HF treatment.",2020,"Left ventricular mechanics showed marked improvement at segmental and global levels of both longitudinal and circumferential myocardial strain (P < .005) when compared with placebo group.
","['Idiopathic Dilated Cardiomyopathy', 'IDCM patients', 'patients with idiopathic dilated cardiomyopathy (IDCM) or not', 'Sixty IDCM patients who were receiving conventional HF treatment']","['oral thyroid hormone treatment', 'L-thyroxine', 'Short-term L-thyroxine therapy', 'oral L-thyroxine', 'Short-Term L-Thyroxine Therapy', 'placebo']","['echocardiographic parameters including end-diastolic diameter', 'Left Ventricular Mechanics', 'end-systolic diameter', 'change left ventricular (LV) mechanics and functional status', 'functional status', 'mitral regurgitation severity reduction', 'Myocardial longitudinal peak systolic strain, systolic strain rate, early and late diastolic strain rate, circumferential strain, LV dyssynchrony, plasma tri-iodothyronine, thyroxine, and thyroid stimulating hormone\xa0levels', 'segmental and global levels of both longitudinal and circumferential myocardial strain', 'cardiac mechanics and functional status', 'ejection fraction']","[{'cui': 'C1449563', 'cui_str': 'Primary idiopathic dilated cardiomyopathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C3160953', 'cui_str': 'Left ventricular dyssynchrony'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0202237', 'cui_str': 'Tri-iodothyronine measurement, total'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1868749', 'cui_str': 'Myocardial strain'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]",60.0,0.0255051,"Left ventricular mechanics showed marked improvement at segmental and global levels of both longitudinal and circumferential myocardial strain (P < .005) when compared with placebo group.
","[{'ForeName': 'Hala Mahfouz', 'Initials': 'HM', 'LastName': 'Badran', 'Affiliation': 'Cardiology Department, Menoufia University, Egypt; Bibliotheca Alexandrina-Hypertrophic Cardiomyopathy National Program, Alexandria, Egypt. Electronic address: halamahfouz_1000@yahoo.com.'}, {'ForeName': 'Naglaa', 'Initials': 'N', 'LastName': 'Faheem', 'Affiliation': 'Cardiology Department, Menoufia University, Egypt; Bibliotheca Alexandrina-Hypertrophic Cardiomyopathy National Program, Alexandria, Egypt.'}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Zidan', 'Affiliation': 'Cardiology Department, Menoufia University, Egypt.'}, {'ForeName': 'Magdi H', 'Initials': 'MH', 'LastName': 'Yacoub', 'Affiliation': 'Bibliotheca Alexandrina-Hypertrophic Cardiomyopathy National Program, Alexandria, Egypt; Cardiothoracic Surgery, Imperial College, London, United Kingdom.'}, {'ForeName': 'Ghada', 'Initials': 'G', 'LastName': 'Soltan', 'Affiliation': 'Cardiology Department, Menoufia University, Egypt.'}]",Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography,['10.1016/j.echo.2020.05.009']
2504,32792425,"Assessment of the impact of a new sequential approach to antimicrobial use in young febrile children in the emergency department (DIAFEVERCHILD): a French prospective multicentric controlled, open, cluster-randomised, parallel-group study protocol.","INTRODUCTION


Fever is one of the most common reasons for consultation in the paediatric emergency department (ED). Because of fear of bacterial infection in parents and caregivers, clinicians often overprescribe laboratory tests and empirical antibiotic treatment. The aims of this study are to demonstrate that using a procalcitonin (PCT) rapid test-based prediction rule (1) would not be inferior to usual practice in terms of morbidity and mortality (non-inferiority objective) and (2) would result in a significant reduction in antibiotic use (superiority objective).
METHODS AND ANALYSIS


This prospective multicentric cluster-randomised study aims to include 7245 febrile children aged 6 days to 3 years with a diagnosis of fever without source in 26 participating EDs in France and Switzerland during a 24-month period. During first period, all children will receive usual care. In a second period, a point-of-care PCT-based algorithm will be used in half of the clusters. The primary endpoints collected on day 15 after ED consultation will be a composite outcome of death or intensive care unit admission for any reason, disease-specific complications, diagnosis of bacterial infection after discharge from the ED for the non-inferiority objective and proportion of children with antibiotic treatment administered for the superiority objective. The endpoints will be compared between the two groups (experimental and control) by using a mixed logistic regression model adjusted on clustering of participants within centres and period within centres.
DISCUSSION


If the algorithm is validated, a new strategy will be discussed with medical societies to safely manage fever in young children without the need for invasive procedures for microbiological testing or empirical antibiotics.
ETHICS AND DISSEMINATION


This study was submitted to an independent ethics committee on 17 May 2018 (no. 2018-A00252-53). Results will be submitted to international peer-reviewed journals and presented at international conferences.
TRIAL REGISTRATION NUMBER


NCT03607162; Pre-results.",2020,"Because of fear of bacterial infection in parents and caregivers, clinicians often overprescribe laboratory tests and empirical antibiotic treatment.","['young febrile children in the emergency department (DIAFEVERCHILD', '7245 febrile children aged 6 days to 3 years with a diagnosis of fever without source in 26 participating EDs in France and Switzerland during a 24-month period', 'young children', 'independent ethics committee on 17 May 2018 (no. 2018-A00252-53']",[],"['composite outcome of death or intensive care unit admission for any reason, disease-specific complications, diagnosis of bacterial infection after discharge from the ED for the non-inferiority objective and proportion of children with antibiotic treatment']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0085546', 'cui_str': 'Ethics Committees'}]",[],"[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004623', 'cui_str': 'Bacterial infectious disease'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",7245.0,0.218545,"Because of fear of bacterial infection in parents and caregivers, clinicians often overprescribe laboratory tests and empirical antibiotic treatment.","[{'ForeName': 'Gaelle', 'Initials': 'G', 'LastName': 'Hubert', 'Affiliation': 'Paediatrics Emergency Department, CHU Nantes, Nantes, France gaelle.hubert@chu-nantes.fr.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Launay', 'Affiliation': 'General Paediatrics Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Feildel Fournial', 'Affiliation': 'Paediatrics Emergency Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Chauvire-Drouard', 'Affiliation': 'Clinical Research Department, Clinical Investigation Center Femme Enfant Adolescent-1413 INSERM, CHU Nantes, Nantes, France.'}, {'ForeName': 'Fleur', 'Initials': 'F', 'LastName': 'Lorton', 'Affiliation': 'Paediatrics Emergency Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Tavernier', 'Affiliation': 'Biostatistics Department, Clinical Investigation Center-1415 INSERM, CHU Tours, Tours, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Giraudeau', 'Affiliation': 'Biostatistics Department, Clinical Investigation Center-1415 INSERM, CHU Tours, Tours, France.'}, {'ForeName': 'Christele', 'Initials': 'C', 'LastName': 'Gras Le Guen', 'Affiliation': 'Paediatrics Emergency Department, CHU Nantes, Nantes, France.'}]",BMJ open,['10.1136/bmjopen-2019-034828']
2505,32792427,Microwave ablation versus radiofrequency ablation for the treatment of severe complicated monochorionic pregnancies in China：protocol for a pilot randomised controlled trial.,"INTRODUCTION


Complicated monochorionic twin pregnancies are often associated with high perinatal morbidity and mortality, some of which are severe enough to require a gestational reduction surgery to improve fetal survival and reduce disabilities. While radiofrequency ablation is currently the most commonly used procedure with higher fetal survival and fewer maternal and fetal complications compared with other surgical methods, the therapeutic effect of microwave ablation (MWA) is reported to be better, presumably due to the higher thermal effect and fewer restrictions. Currently there is limited evidence to prove the feasibility of MWA for selective reduction. The aim of this pilot study is to explore the feasibility, efficacy and safety of MWA reduction for severe complicated monochorionic pregnancies and may provide evidence for using the MWA in intrauterine surgeries extensively.
METHODS AND ANALYSIS


This is a study protocol for a parallel-design pilot randomised controlled trial. 60 eligible patients with severe complicated monochorionic pregnancies will be randomised in a ratio of 1:1 to MWA group and radiofrequency group. Patients will be followed up until 6 months of age of the retained fetal. The primary analysis will compare the rates of neonatal survival at 28 days to evaluate the effect of MWA. The study will also evaluate the safety profile of MWA including the occurrence of postoperative adverse events and maternal and fetal complications. Additional secondary outcomes to be explored include the condition of neonatal asphyxia and the growth of surviving fetus at 6 months. Outcomes will be analysed by both a frequentist and the Bayesian statistical approach.
ETHICS AND DISSEMINATION


This study was approved by the ethical review committee of the Peking University Third Hospital (Beijing, China). The results of this study will be published in peer-reviewed scientific journals and presented at relevant academic conferences.
TRIAL REGISTRATION NUMBER


NCT04014452; Pre-results.",2020,"While radiofrequency ablation is currently the most commonly used procedure with higher fetal survival and fewer maternal and fetal complications compared with other surgical methods, the therapeutic effect of microwave ablation (MWA) is reported to be better, presumably due to the higher thermal effect and fewer restrictions.","['Peking University Third Hospital (Beijing, China', '60 eligible patients with severe complicated monochorionic pregnancies', 'severe complicated monochorionic pregnancies']","['Microwave ablation versus radiofrequency ablation', 'radiofrequency ablation', 'MWA', 'MWA group and radiofrequency group']","['condition of neonatal asphyxia and the growth of surviving fetus at 6 months', 'rates of neonatal survival']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C3854551', 'cui_str': 'Microwave ablation'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0004045', 'cui_str': 'Asphyxia, in liveborn infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",60.0,0.194793,"While radiofrequency ablation is currently the most commonly used procedure with higher fetal survival and fewer maternal and fetal complications compared with other surgical methods, the therapeutic effect of microwave ablation (MWA) is reported to be better, presumably due to the higher thermal effect and fewer restrictions.","[{'ForeName': 'Jialei', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Ziyi', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Tianchen', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China xlwang@bjmu.edu.cn weiyuanbysy@163.com.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing, China xlwang@bjmu.edu.cn weiyuanbysy@163.com.'}]",BMJ open,['10.1136/bmjopen-2019-034995']
2506,32792431,Impact of incremental versus conventional initiation of haemodialysis on residual kidney function: study protocol for a multicentre feasibility randomised controlled trial.,"INTRODUCTION


Preserving residual kidney function (RKF) may be beneficial to patients on haemodialysis (HD) and it has been proposed that commencing dialysis incrementally rather than three times a week may preserve RKF. In Incremental HD, target dose includes a contribution from RKF, which is added to HD dose, allowing individualisation of the HD prescription. We will conduct a feasibility randomised controlled trial (RCT) comparing incremental HD and conventional three times weekly treatments in incident HD patients. The study is designed also to provide pilot data to allow determination of effect size to power a definitive study.
METHODS AND ANALYSIS


After screening to ensure native renal urea clearance >3 mL/min/1.73 m 2 , the study will randomise 54 patients within 3 months of HD initiation to conventional in-centre thrice weekly dialysis or incremental in-centre HD commencing 2 days a week. Subjects will be followed up for 12 months. The study will be carried out across four UK renal centres.The primary outcome is to evaluate the feasibility of conducting a definitive RCT and to estimate the difference in rate of decline of RKF between the two groups at 6 and 12 months time points. Secondary outcomes will include the impact of dialysis intensity on vascular access events, major adverse cardiac events and survival. Impact of dialysis intensity on patient-reported outcomes measures, cognition and frailty will be assessed using EQ-5D-5L, PHQ-9, Illness Intrusiveness Rating Score, Montreal Cognitive assessment and Clinical Frailty Score. Safety outcomes include hospitalisation, fluid overload episodes, hyperkalaemia events and vascular access events.This study will inform the design of a definitive study, adequately powered to determine whether RKF is better preserved after incremental HD initiation compared with conventional initiation.
ETHICS AND DISSEMINATION


Ethics approval has been granted by Cambridge South Research Ethics Committee, United Kingdom(REC17/EE/0311). Results will be disseminated via peer-reviewed publication.
TRIAL REGISTRATION NUMBER


NCT03418181.",2020,"Safety outcomes include hospitalisation, fluid overload episodes, hyperkalaemia events and vascular access events.","['incident HD patients', 'four UK renal centres']","['RKF', 'incremental versus conventional initiation of haemodialysis']","['impact of dialysis intensity on vascular access events, major adverse cardiac events and survival', 'feasibility of conducting a definitive RCT', 'hospitalisation, fluid overload episodes, hyperkalaemia events and vascular access events', 'EQ-5D-5L, PHQ-9, Illness Intrusiveness Rating Score, Montreal Cognitive assessment and Clinical Frailty Score', 'residual kidney function', 'rate of decline of RKF']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0546817', 'cui_str': 'Hypervolemia'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]",54.0,0.192481,"Safety outcomes include hospitalisation, fluid overload episodes, hyperkalaemia events and vascular access events.","[{'ForeName': 'Raja Mohammed', 'Initials': 'RM', 'LastName': 'Kaja Kamal', 'Affiliation': 'Renal Unit, East and North Hertfordshire NHS Trust, Stevenage, UK.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Farrington', 'Affiliation': 'Renal Unit, East and North Hertfordshire NHS Trust, Stevenage, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wellsted', 'Affiliation': 'School of Life Sciences, University of Hertfordshire, Hatfield, Hertfordshire, UK.'}, {'ForeName': 'Sivakumar', 'Initials': 'S', 'LastName': 'Sridharan', 'Affiliation': 'Renal Unit, East and North Hertfordshire NHS Trust, Stevenage, UK.'}, {'ForeName': 'Bassam', 'Initials': 'B', 'LastName': 'Alchi', 'Affiliation': 'Renal Unit, Royal Berkshire NHS Foundation Trust, Reading, Berkshire, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Burton', 'Affiliation': 'Renal Unit, University Hospitals of Leicester NHS Trust, Leicester, Leicestershire, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Davenport', 'Affiliation': 'Renal Unit, Royal Free Hospital, London, UK.'}, {'ForeName': 'Enric', 'Initials': 'E', 'LastName': 'Vilar', 'Affiliation': 'Renal Unit, East and North Hertfordshire NHS Trust, Stevenage, UK enric.vilar@nhs.net.'}]",BMJ open,['10.1136/bmjopen-2019-035919']
2507,32792446,"The GALANT trial: study protocol of a randomised placebo-controlled trial in patients with a  68   Ga  -DOTATATE PET-positive, clinically non-functioning pituitary macroadenoma on the effect of  lan  reotide on  t  umour size.","INTRODUCTION


At present, there is no approved medical treatment option for patients with non-functioning pituitary adenoma. A number of open-label studies suggest that treatment with somatostatin analogues may prevent tumour progression. In vivo somatostatin receptor imaging using  68 Ga-DOTATATE PET (PET, positron emission tomography) could help in preselecting patients potentially responsive to treatment. Our aim is to investigate the effect of the somatostatin analogue lanreotide as compared with placebo on tumour size in patients with a  68 Ga-DOTATATE PET-positive non-functioning pituitary macroadenoma (NFMA).
METHODS AND ANALYSIS


The GALANT study is a multicentre, randomised, double-blind, placebo-controlled trial in adult patients with a suprasellar extending NFMA. Included patients undergo a  68 Ga-DOTATATE PET/CT of the head and tracer uptake is assessed after coregistration with pituitary MRI. Forty-four patients with a  68 Ga-DOTATATE PET-positive NFMA are randomised in a 1:1 ratio between lanreotide 120 mg or placebo, both administered as subcutaneous injections every 28 days for 72 weeks. The primary outcome is the change in cranio-caudal tumour diameter on pituitary MRI after treatment. Secondary outcomes are change in tumour volume, time to tumour progression, change in quality of life and number of adverse events. Final results are expected in the second half of 2021.
ETHICS AND DISSEMINATION


The study protocol has been approved by the Medical Research Ethics Committee of the Academic Medical Centre (AMC) of the Amsterdam University Medical Centres and by the Dutch competent authority. It is an investigator-initiated study with financial support by Ipsen Farmaceutica BV. The AMC, as sponsor, remains owner of all data. Results will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


NL5136 (Netherlands Trial Register); pre-recruitment.",2020,"Secondary outcomes are change in tumour volume, time to tumour progression, change in quality of life and number of adverse events.","['patients with a  68 Ga-DOTATATE PET-positive non-functioning pituitary macroadenoma (NFMA', 'Forty-four patients with a  68 Ga-DOTATATE PET-positive NFMA', 'patients with a  68   Ga  -DOTATATE PET-positive, clinically non-functioning pituitary macroadenoma on the effect of  lan  reotide on  t  umour size', 'patients with non-functioning pituitary adenoma', 'adult patients with a suprasellar extending NFMA']","['somatostatin analogue lanreotide', 'lanreotide 120 mg or placebo', 'placebo']","['change in cranio-caudal tumour diameter on pituitary MRI', 'change in tumour volume, time to tumour progression, change in quality of life and number of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0303226', 'cui_str': 'Gallium-68'}, {'cui': 'C4256789', 'cui_str': 'dotatate'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0346308', 'cui_str': 'Pituitary macroadenoma'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0023933', 'cui_str': 'LAN'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0338078', 'cui_str': 'Functionless pituitary adenoma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0230054', 'cui_str': 'Structure of suprasellar region'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0732165', 'cui_str': 'Somatostatin analog'}, {'cui': 'C0209211', 'cui_str': 'lanreotide'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205097', 'cui_str': 'Caudal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0475276', 'cui_str': 'Tumor volume'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",44.0,0.570073,"Secondary outcomes are change in tumour volume, time to tumour progression, change in quality of life and number of adverse events.","[{'ForeName': 'Tessel M', 'Initials': 'TM', 'LastName': 'Boertien', 'Affiliation': 'Department of Endocrinology and Metabolism, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands t.m.boertien@amsterdamumc.nl.'}, {'ForeName': 'Madeleine L', 'Initials': 'ML', 'LastName': 'Drent', 'Affiliation': 'Department of Internal Medicine, Section of Endocrinology, Amsterdam UMC, location VUMC, VU University, Amsterdam, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Booij', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Charles B L M', 'Initials': 'CBLM', 'LastName': 'Majoie', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Marcel P M', 'Initials': 'MPM', 'LastName': 'Stokkel', 'Affiliation': 'Department of Nuclear Medicine, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Jantien', 'Initials': 'J', 'LastName': 'Hoogmoed', 'Affiliation': 'Department of Neurosurgery, Neurosurgical Centre Amsterdam, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Pereira', 'Affiliation': 'Department of Medicine, Division of Endocrinology, and Centre for Endocrine Tumors Leiden (CETL), Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Nienke R', 'Initials': 'NR', 'LastName': 'Biermasz', 'Affiliation': 'Department of Medicine, Division of Endocrinology, and Centre for Endocrine Tumors Leiden (CETL), Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Suat', 'Initials': 'S', 'LastName': 'Simsek', 'Affiliation': 'Department of Internal Medicine, Section of Endocrinology, Amsterdam UMC, location VUMC, VU University, Amsterdam, The Netherlands.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Groote Veldman', 'Affiliation': 'Department of Internal Medicine, Medical Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Michael W T', 'Initials': 'MWT', 'LastName': 'Tanck', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Fliers', 'Affiliation': 'Department of Endocrinology and Metabolism, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Bisschop', 'Affiliation': 'Department of Endocrinology and Metabolism, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2020-038250']
2508,32792614,Alterations in acid-base balance and high-intensity exercise performance after short-term and long-term exposure to acute normobaric hypoxic conditions.,"This investigation assessed the course of renal compensation of hypoxia-induced respiratory alkalosis by elimination of bicarbonate ions and impairments in anaerobic exercise after different durations of hypoxic exposure. Study A: 16 participants underwent a resting 12-h exposure to normobaric hypoxia (3,000 m). Blood gas analysis was assessed hourly. While blood pH was significantly increased, PO 2 , PCO 2 , and SaO 2  were decreased within the first hour of hypoxia, and changes remained consistent. A substantial reduction in [HCO 3 - ] levels was observed after 12 h of hypoxic exposure (- 1.35 ± 0.29 mmol/L, p ≤ 0.05). Study B: 24 participants performed in a randomized, cross-over trial portable tethered sprint running (PTSR) tests under normoxia and after either 1 h (n = 12) or 12 h (n = 12) of normobaric hypoxia (3,000 m). No differences occurred for PTSR-related performance parameters, but the reduction in blood lactate levels was greater after 12 h compared with 1 h (- 1.9 ± 2.2 vs 0.0 ± 2.3 mmol/L, p ≤ 0.05). These results indicate uncompensated respiratory alkalosis after 12 h of hypoxia and similar impairment of high-intensity exercise after 1 and 12 h of hypoxic exposure, despite a greater reduction in blood lactate responses after 12 h compared with 1 h of hypoxic exposure.",2020,"No differences occurred for PTSR-related performance parameters, but the reduction in blood lactate levels was greater after 12 h compared with 1 h (- 1.9 ± 2.2 vs 0.0 ± 2.3 mmol/L, p ≤ 0.05).",[' 16 participants underwent a'],"['resting 12-h exposure to normobaric hypoxia', 'portable tethered sprint running (PTSR) tests under normoxia and after either 1\xa0h (n\u2009=\u200912) or 12\xa0h (n\u2009=\u200912) of normobaric hypoxia']","['PTSR-related performance parameters', 'blood pH', 'PO 2 , PCO 2 , and SaO 2', 'blood lactate levels', 'Blood gas analysis', 'blood lactate responses', 'respiratory alkalosis']",[],"[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0577538', 'cui_str': 'Tethered'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0700308', 'cui_str': 'Protium'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0853363', 'cui_str': 'Blood pH'}, {'cui': 'C0297199', 'cui_str': 'PO-2'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0002064', 'cui_str': 'Respiratory alkalosis'}]",,0.0252108,"No differences occurred for PTSR-related performance parameters, but the reduction in blood lactate levels was greater after 12 h compared with 1 h (- 1.9 ± 2.2 vs 0.0 ± 2.3 mmol/L, p ≤ 0.05).","[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Limmer', 'Affiliation': 'Institute of Sports Medicine and Sports Nutrition, Ruhr-University Bochum, Bochum, Germany. mirjam.limmer@rub.de.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'de Marées', 'Affiliation': 'Institute of Sports Medicine and Sports Nutrition, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Platen', 'Affiliation': 'Institute of Sports Medicine and Sports Nutrition, Ruhr-University Bochum, Bochum, Germany.'}]",Scientific reports,['10.1038/s41598-020-70762-z']
2509,32792635,Early use of combined exogenous surfactant and inhaled nitric oxide reduces treatment failure in persistent pulmonary hypertension of the newborn: a randomized controlled trial.,"OBJECTIVE


To evaluate whether combined surfactant with inhaled nitric oxide (iNO) use will prevent newborns with hypoxemic respiratory failure (HRF) from developing an Oxygenation Index (OI) > 40.
METHODS


100 term newborns with acute HRF (OI ≥ 20) were randomized to: Surfactant+iNO: received iNO plus up to two doses of surfactant or iNO-Controls: received iNO+placebo. Main outcome was the development of severe HRF (OI > 40) despite iNO use.
RESULTS


Baseline mean ± SD OI was 37.4 ± 14 for the Surfactant+iNO group and 38.2 ± 16 for the controls. Infants receiving surfactant+iNO improved their oxygenation faster, resulting in lower OI at 24 h: 12.9 ± 9 vs 18.7 ± 11 of controls, p < 0.05; and a lower proportion developing OI > 40: 24%(12/50) vs 50%(25/50) of controls, p < 0.02. Fewer infants receiving surfactant+iNO presented the combined outcome of death or ECMO: 16%(8/50) compared to 36%(18/50) of controls, p < 0.05.
CONCLUSIONS


Early use of combined surfactant+iNO improves oxygenation preventing the progression to severe HRF. This may reduce mortality and ECMO need.",2020,"Infants receiving surfactant+iNO improved their oxygenation faster, resulting in lower OI at 24 h: 12.9 ± 9 vs 18.7 ± 11 of controls, p < 0.05; and a lower proportion developing OI > 40: 24%(12/50) vs 50%(25/50) of controls, p < 0.02.","['newborns with hypoxemic respiratory failure (HRF) from developing an Oxygenation Index (OI)\u2009>\u200940', 'persistent pulmonary hypertension of the newborn', '100 term newborns with acute HRF (OI\u2009≥\u200920']","['combined surfactant with inhaled nitric oxide (iNO', 'combined exogenous surfactant and inhaled nitric oxide', 'Surfactant+iNO: received iNO plus up to two doses of surfactant or iNO-Controls: received iNO+placebo']","['death or ECMO', 'development of severe HRF (OI\u2009>\u200940) despite iNO use', 'oxygenation faster']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0340194', 'cui_str': 'Respiratory failure without hypercapnia'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0031190', 'cui_str': 'Persistent pulmonary hypertension of the newborn'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C4039867', 'cui_str': 'Acute hypoxemic respiratory failure'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0340194', 'cui_str': 'Respiratory failure without hypercapnia'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}]",100.0,0.237933,"Infants receiving surfactant+iNO improved their oxygenation faster, resulting in lower OI at 24 h: 12.9 ± 9 vs 18.7 ± 11 of controls, p < 0.05; and a lower proportion developing OI > 40: 24%(12/50) vs 50%(25/50) of controls, p < 0.02.","[{'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'González', 'Affiliation': 'Department of Neonatology, Division of Pediatrics, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile. alvgonza@med.puc.cl.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Bancalari', 'Affiliation': 'Hospital Guillermo Grant Benavente and Department of Pediatrics, Faculty of Medicine, Universidad de Concepción, Concepción, Chile.'}, {'ForeName': 'Waldo', 'Initials': 'W', 'LastName': 'Osorio', 'Affiliation': 'Hospital Luis Tisné, Santiago, Chile.'}, {'ForeName': 'Matías', 'Initials': 'M', 'LastName': 'Luco', 'Affiliation': 'Department of Neonatology, Division of Pediatrics, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Agustina', 'Initials': 'A', 'LastName': 'González', 'Affiliation': 'Hospital San José, Santiago, Chile.'}, {'ForeName': 'Héctor', 'Initials': 'H', 'LastName': 'Pérez', 'Affiliation': 'Department of Neonatology, Division of Pediatrics, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Kattan', 'Affiliation': 'Department of Neonatology, Division of Pediatrics, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-00777-x']
2510,32792703,Extraocular Myoplasty: Surgical Remedy For Intraocular Implant Exposure.,"BACKGROUND


Evisceration and nucleation are commonly performed ophthalmic surgeries for painful blind eye, disfiguring blind eye, endophthalmitis etc. After both these surgeries it is important to replace the lost volume in the orbit with implant. Implant is associated with many complications such as major discharge, exposure with discharge and implant exposure. The main surgical management of implant exposures basically primary revision or patch grafting with or without removal of the implant.
CASE


A 60 years old man presented to ophthalmic OPD with complaint of foreign body sensation and irritation in left eye. There was history of evisceration with silicon ball implant in left eye done one month back for painful blind eye at another hospital. On ophthalmic examination, there was a 3 × 4 mm of implant exposure most probably dueto tight closure. As per records the size of implant was 22mm. The patient was planned for extra-ocular myoplasty with buccal mucosal graft under general anesthesia.
OBSERVATION


After sterile prepping and draping, 360˚ degrees peritomy was performed and care was taken to dissect between tenons and orbital implant. Medialand lateral recti were isolated and dissected upto 10-12mm from insertion site. Both the recti were secured with 6-0 vicryl suture and were detached from their respective insertions, advanced and approximated over the site of implant exposure. Thus the exposed implant was covered with a vascularized base which was reinforced with amucosal graft harvested from the buccal mucosa and secured with absorbable sutures. After 1 year of follow up patient was asymptomatic.
CONCLUSION


Extraocular myoplasty with buccal mucosal graft is a good surgical remedy for orbital implant exposure implant.",2019,"BACKGROUND


Evisceration and nucleation are commonly performed ophthalmic surgeries for painful blind eye, disfiguring blind eye, endophthalmitis etc.",['60 years old man presented to ophthalmic OPD with complaint of foreign body sensation and irritation in left eye'],['implant exposures basically primary revision or patch grafting with or without removal of the implant'],['Medialand lateral recti'],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0423602', 'cui_str': 'Foreign body sensation'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0229090', 'cui_str': 'Left eye structure'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0582821', 'cui_str': 'Lateral rectus muscle structure'}]",,0.0608314,"BACKGROUND


Evisceration and nucleation are commonly performed ophthalmic surgeries for painful blind eye, disfiguring blind eye, endophthalmitis etc.","[{'ForeName': 'Anupam', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Ophthalmology, All India Institute of Medical Sciences, Rishikesh.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Vathulya', 'Affiliation': ''}, {'ForeName': 'Ajai', 'Initials': 'A', 'LastName': 'Agrawal', 'Affiliation': ''}, {'ForeName': 'Rupal', 'Initials': 'R', 'LastName': 'Verma', 'Affiliation': ''}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Mittal', 'Affiliation': ''}, {'ForeName': 'Barun', 'Initials': 'B', 'LastName': 'Kumar', 'Affiliation': ''}]",Nepalese journal of ophthalmology : a biannual peer-reviewed academic journal of the Nepal Ophthalmic Society : NEPJOPH,['10.3126/nepjoph.v11i2.27839']
2511,32790496,Maytenus ilicifolia  Extract Increases Oxygen Uptake without Changes in Neuromuscular Fatigue Development during a High-Intensity Interval Exercise.,"OBJECTIVE


We investigated the effects of acute ingestion of  Maytenus ilicifolia  extract on metabolic and cardiopulmonary responses during a high-intensity interval exercise (HIIE), and its consequence on neuromuscular fatigue.
METHODS


Ten healthy men underwent a HIIE (4 x 4 min, 3 min recovery) one hour after ingesting 400 mg of  Maytenus ilicifolia  extract (MIE) or placebo. Oxygen uptake ([Formula: see text]O 2 ), dioxide carbon production ([Formula: see text]CO 2 ), ventilation ([Formula: see text]E) and heart rate (HR) were measured throughout the HIIE. Maximal voluntary contraction (MVC), voluntary activation (VA), and evoked 1, 10 and 100 Hz force twitch were measured before supplementation (baseline), and before (pre-HIIE) and after the HIIE (post-HIIE).
RESULTS


The [Formula: see text]O 2 , [Formula: see text]E, [Formula: see text]E/[Formula: see text]O 2  ratio and HR increased progressively throughout the HIIE under both conditions (p < 0.05). MIE increased HR, however, at bouts 1 and 2 and mean [Formula: see text]O 2  during HIIE. The mean respiratory exchange ratio during recovery was also reduced with MIE (p < 0.05). MVC and evoked force at 1, 10 and 100 Hz declined similarly after HIIE, regardless of the condition (MIE: -18 ± 17%, -50 ± 15%, -61 ± 13% and -34 ± 10%  vs.  placebo: -19 ± 15%, -48 ± 16%, -58 ± 12 and -29 ± 11%, respectively, p < 0.05). There was no effect of exercise or MIE on VA (p > 0.05).
CONCLUSION


MIE increases heart rate in the first bouts and mean oxygen uptake during HIIE without changes in neuromuscular fatigue development.",2020,MIE increases heart rate in the first bouts and mean oxygen uptake during HIIE without changes in neuromuscular fatigue development.,['Ten healthy men'],"['MIE', 'Oxygen uptake ([Formula: see text]O 2 ), dioxide carbon production', 'Maytenus ilicifolia  extract', 'HIIE (4 x 4\u2009min, 3\u2009min recovery) one hour after ingesting 400\u2009mg of  Maytenus ilicifolia  extract (MIE) or placebo', 'placebo']","['mean respiratory exchange ratio during recovery', 'metabolic and cardiopulmonary responses', 'MVC and evoked force', 'heart rate (HR', 'heart rate', 'Maximal voluntary contraction (MVC), voluntary activation (VA), and evoked 1, 10 and 100\u2009Hz force twitch']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}]",10.0,0.181574,MIE increases heart rate in the first bouts and mean oxygen uptake during HIIE without changes in neuromuscular fatigue development.,"[{'ForeName': 'Guilherme A', 'Initials': 'GA', 'LastName': 'Ferreira', 'Affiliation': 'Associated Program of Post-Graduation in Physical Education UPE/UFPB, University of Pernambuco, Recife, Brazil.'}, {'ForeName': 'Leandro C', 'Initials': 'LC', 'LastName': 'Felippe', 'Affiliation': 'Sports Science Research Group, Academic Center of Vitoria, Federal University of Pernambuco, Pernambuco, Brazil.'}, {'ForeName': 'Marcos D', 'Initials': 'MD', 'LastName': 'Silva-Cavalcante', 'Affiliation': 'Sports Science Research Group, Academic Center of Vitoria, Federal University of Pernambuco, Pernambuco, Brazil.'}, {'ForeName': 'Ana Paula A', 'Initials': 'APA', 'LastName': 'De-Mello', 'Affiliation': 'Sports Science Research Group, Academic Center of Vitoria, Federal University of Pernambuco, Pernambuco, Brazil.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Coelho', 'Affiliation': 'Center of Engineering, Modeling, and Applied Social Science, Federal University of ABC, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Maranhão', 'Affiliation': 'Sports Science Research Group, Academic Center of Vitoria, Federal University of Pernambuco, Pernambuco, Brazil.'}, {'ForeName': 'Rômulo', 'Initials': 'R', 'LastName': 'Bertuzzi', 'Affiliation': 'Endurance Performance Research Group (GEDAE-USP), University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Dolinsky', 'Affiliation': 'Departament of Nutrition and Dietetic, Federal Fluminense University, Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Fernando R', 'Initials': 'FR', 'LastName': 'De-Oliveira', 'Affiliation': 'Center for Studies of Human Movement, Federal University of Lavras, Lavras, Brazil.'}, {'ForeName': 'Adriano E', 'Initials': 'AE', 'LastName': 'Lima-Silva', 'Affiliation': 'Sports Science Research Group, Academic Center of Vitoria, Federal University of Pernambuco, Pernambuco, Brazil.'}, {'ForeName': 'Kleber J', 'Initials': 'KJ', 'LastName': 'Da-Silva', 'Affiliation': 'Sports Science Research Group, Academic Center of Vitoria, Federal University of Pernambuco, Pernambuco, Brazil.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2020.1787906']
2512,32790537,Four weeks of high-intensity interval training (HIIT) improve the cardiometabolic risk profile of overweight patients with type 1 diabetes mellitus (T1DM).,"This study investigated the effects of a four-week HIIT intervention on the cardiometabolic risk profile, liver fat content, insulin requirement, hypoglycaemia, physical fitness, and health-related quality of life in patients with T1DM. A supervised exercise intervention with baseline to follow-up comparison between overweight (BMI= 28.6±2.1 kg/m 2 ) and normal weight (BMI=23.2±1.40 kg/m 2 ) T1DM patients was performed. Eleven overweight (age = 40.7±14.3 years) and 11 normal weight (age = 42.2±15.5 years) T1DM patients performed a four-week, low-volume, all-out cycling HIIT (4-6 bouts, work/relief ratio 1:1) twice weekly. HIIT lowered low-density lipoprotein and uric acid levels in overweight patients by up to 10.5% (vs. normal weight, p≤0.0312). HbA1c, high-density lipoprotein, and triglyceride levels did not change in any of the groups. Participants' maximal exercise capacity and power output at individual anaerobic lactate threshold increased to an equal extend of up to 10% (p≤0.0002) in both groups. During the intervention, participants used fewer daily bolus insulin (-5.22±12.80%) and less total units of insulin (-4.42±10.20%, p≤0.023) compared to the pre-intervention period with no between-group difference. Overall, the average daily number of hypoglycaemias increased from 0.90±0.56 to 1.08±0.63 during the intervention (p=0.033). SF-36 subscales showed higher scores after the intervention, with a significant improvement of 'role limitations due to physical problems' (p<0.05) for both groups. We conclude that in T1DM, HIIT may exert beneficial effects on physical fitness, insulin requirement and health-related quality of life. Of note, beneficial HIIT effects on the cardiometabolic risk profile in T1DM may be larger in overweight T1DM patients.",2020,"SF-36 subscales showed higher scores after the intervention, with a significant improvement of 'role limitations due to physical problems' (p<0.05) for both groups.","['patients with T1DM', 'Eleven overweight (age = 40.7±14.3 years) and 11 normal weight (age = 42.2±15.5 years', 'overweight T1DM patients', 'overweight patients with type 1 diabetes mellitus (T1DM']","['HIIT intervention', 'supervised exercise intervention', 'high-intensity interval training (HIIT']","['cardiometabolic risk profile, liver fat content, insulin requirement, hypoglycaemia, physical fitness, and health-related quality of life', 'HIIT lowered low-density lipoprotein and uric acid levels', 'total units of insulin', 'physical fitness, insulin requirement and health-related quality of life', 'average daily number of hypoglycaemias', 'maximal exercise capacity and power output at individual anaerobic lactate threshold', 'cardiometabolic risk profile', 'HbA1c, high-density lipoprotein, and triglyceride levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}]",11.0,0.0311131,"SF-36 subscales showed higher scores after the intervention, with a significant improvement of 'role limitations due to physical problems' (p<0.05) for both groups.","[{'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Minnebeck', 'Affiliation': 'Internal Medicine B, Department of Diabetology and Endocrinology, University Hospital Muenster, Germany.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Vorona', 'Affiliation': 'Internal Medicine B, Department of Diabetology and Endocrinology, University Hospital Muenster, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Zinn', 'Affiliation': 'Institute of Sports Medicine, Molecular Genetics of Cardiovascular Disease, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Reinhold', 'Initials': 'R', 'LastName': 'Gellner', 'Affiliation': 'Internal Medicine B, Department of Diabetology and Endocrinology, University Hospital Muenster, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Hinder', 'Affiliation': 'Institute of Sports Medicine, Molecular Genetics of Cardiovascular Disease, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Stefan-Martin', 'Initials': 'SM', 'LastName': 'Brand', 'Affiliation': 'Institute of Sports Medicine, Molecular Genetics of Cardiovascular Disease, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Iyad', 'Initials': 'I', 'LastName': 'Kabar', 'Affiliation': 'Internal Medicine B, Department of Diabetology and Endocrinology, University Hospital Muenster, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Alten', 'Affiliation': 'Department of Ophthalmology, University of Muenster Medical Center, Muenster, Germany.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Schmitz', 'Affiliation': 'Institute of Sports Medicine, Molecular Genetics of Cardiovascular Disease, University Hospital Muenster, Muenster, Germany.'}]",European journal of sport science,['10.1080/17461391.2020.1810782']
2513,32790539,Food and Drug Administration and Institutional Review Board Approval of a Novel Prehospital Informed Consent Process for Emergency Research.,"Research on the management of acute pain in the prehospital setting is fraught with challenges. The prehospital setting is complex due to constrained time, resources, and training. Research activities must not interfere with the underlying clinical priorities of immediate patient stabilization and rapid transport to an appropriate hospital. The patient's pain, fear, and anxiety immediately after a traumatic event may interfere with undertaking an adequate informed consent process.Pain management trials do not satisfy the criteria for application of the U.S. Food and Drug Administration (FDA) 21 CFR 50.24 exception from informed consent. While non-standard informed consent processes exist, waiver or alteration of informed consent may be limited if Institutional Review Boards or the FDA consider these studies to involve more than minimal risk related to the setting of the study, even if the interventions themselves might involve no more than minimal risk in other settings. In addition, any study requiring an Investigational New Drug application requires fully documented standard informed consent.Emergency Medical Services agencies and fire departments become research institutions, and paramedics become study staff, but both the institutions and the staff often lack experience conducting human subjects research and are rarely formally affiliated with the academic institution overseeing the research. As such, additional administrative burdens must be overcome in interventional prehospital studies, including additional training in the study protocol, research operations, and human subjects protections. Institutions conducting federally funded studies commit to regulations covering human subjects protections in the form of a Federalwide Assurance (FWA); prehospital organizations participating in research must either obtain an FWA or have coverage extended to them from an academic partner.We describe how these challenges were addressed during Institutional Review Board review and approval of an FDA-regulated randomized placebo-controlled trial of intranasal ketamine (vs. placebo) in acutely injured patients receiving standard of care fentanyl for prehospital pain management (NCT02866071). To our knowledge, this trial is the first instance in the United States of paramedics screening, consenting, enrolling, and administering study medications to patients without direct, real-time support from a dedicated clinical research team.",2020,"While non-standard informed consent processes exist, waiver or alteration of informed consent may be limited if Institutional Review Boards or the FDA consider these studies to involve more than minimal risk related to the setting of the study, even if the interventions themselves might involve no more than minimal risk in other settings.",['acutely injured patients receiving standard of care fentanyl for prehospital pain management (NCT02866071'],"['intranasal ketamine', 'placebo']","[""patient's pain, fear, and anxiety""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0310375,"While non-standard informed consent processes exist, waiver or alteration of informed consent may be limited if Institutional Review Boards or the FDA consider these studies to involve more than minimal risk related to the setting of the study, even if the interventions themselves might involve no more than minimal risk in other settings.","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'McMullan', 'Affiliation': 'University of Cincinnati, Department of Emergency Medicine.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Droege', 'Affiliation': 'UC Health - University of Cincinnati Medical Center, Department of Pharmacy.'}, {'ForeName': 'Col Richard', 'Initials': 'CR', 'LastName': 'Strilka', 'Affiliation': 'United States Air Force and University of Cincinnati, Department of Surgery.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lindsell', 'Affiliation': 'Vanderbilt University Medical Center, Department of Biostatistics.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Linke', 'Affiliation': 'University of Cincinnati, Cincinnati, OH.'}]",Prehospital emergency care : official journal of the National Association of EMS Physicians and the National Association of State EMS Directors,['10.1080/10903127.2020.1806969']
2514,32790575,Effects of Static and Dynamic Stretching With Strengthening Exercises in Patients With Patellofemoral Pain Who Have Inflexible Hamstrings: A Randomized Controlled Trial.,"BACKGROUND


Patellofemoral pain (PFP) syndrome is closely associated with muscle tightness. However, studies regarding the effects of stretching exercises on PFP patients with inflexible hamstrings are scarce. The aim of the study was to compare the effects between static and dynamic hamstring stretching in patients with PFP who have inflexible hamstrings.
HYPOTHESIS


Compared with static hamstring stretching, dynamic hamstring stretching will improve the parameters of hamstring flexibility, knee muscle strength, muscle activation time, and clinical outcomes in this patient population.
STUDY DESIGN


Prospective randomized controlled trial.
LEVEL OF EVIDENCE


Level 2.
METHODS


A total of 46 patients (25, static stretching; 21, dynamic stretching) participated. Hamstring flexibility was assessed according to the popliteal angle during active knee extension. Muscle strength and muscle activation time were measured using an isokinetic device. Clinical outcomes were evaluated using the visual analog scale (VAS) for pain and the anterior knee pain scale (AKPS).
RESULTS


There were no differences in hamstring flexibility and knee muscle strength of the affected knees between the groups ( P  > 0.05). Significantly improved muscle activation time and clinical outcomes of the affected knees were observed in the dynamic stretching group compared with the static stretching group (all  Ps  < 0.01 for hamstring, quadriceps, VAS, and AKPS).
CONCLUSION


In patients with PFP who have inflexible hamstrings, dynamic hamstring stretching with strengthening exercises was superior for improving muscle activation time and clinical outcomes compared with static hamstring stretching with strengthening exercises.
CLINICAL RELEVANCE


Clinicians and therapists could implement dynamic hamstring stretching to improve function and reduce pain in patients with PFP who have inflexible hamstrings.",2020,There were no differences in hamstring flexibility and knee muscle strength of the affected knees between the groups ( P  > 0.05).,"['46 patients (25, static stretching; 21, dynamic stretching) participated', 'patients with PFP who have inflexible hamstrings', 'Patients With Patellofemoral Pain', 'Who Have Inflexible Hamstrings', 'PFP patients with inflexible hamstrings']","['static stretching', 'stretching exercises', 'static hamstring stretching with strengthening exercises', 'static hamstring stretching, dynamic hamstring stretching', 'static and dynamic hamstring stretching', 'Static and Dynamic Stretching With Strengthening Exercises']","['Muscle strength and muscle activation time', 'hamstring flexibility, knee muscle strength, muscle activation time, and clinical outcomes', 'hamstring flexibility and knee muscle strength', 'Hamstring flexibility', 'muscle activation time and clinical outcomes', 'visual analog scale (VAS) for pain and the anterior knee pain scale (AKPS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}]","[{'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0556829', 'cui_str': 'Hamstring stretching'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C1720869', 'cui_str': 'Dynamic Stretching'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",46.0,0.0662771,There were no differences in hamstring flexibility and knee muscle strength of the affected knees between the groups ( P  > 0.05).,"[{'ForeName': 'Jin Hyuck', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy and School of Health and Environmental Science, College of Health Science, Korea University, Seoul, Korea.'}, {'ForeName': 'Ki-Mo', 'Initials': 'KM', 'LastName': 'Jang', 'Affiliation': 'Department of Sports Medical Center, Korea University College of Medicine, Anam Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Eunseon', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Department of Sports Medical Center, Korea University College of Medicine, Anam Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hye Chang', 'Initials': 'HC', 'LastName': 'Rhim', 'Affiliation': 'Department of Orthopaedic Surgery, Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyeong-Dong', 'Initials': 'HD', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy and School of Health and Environmental Science, College of Health Science, Korea University, Seoul, Korea.'}]",Sports health,['10.1177/1941738120932911']
2515,32790591,Reproducible improvement in endothelial function following two separate periods of high intensity interval training in young males.,"INTRODUCTION


High intensity interval training (HIIT) can improve vascular function, as assessed by brachial artery flow mediated dilation (FMD). However, when separated by a period of detraining, the reproducibility of FMD responses to repeated periods of HIIT is unknown. The purpose of this study was to determine the group mean and intra-individual reproducibility of FMD responses to two, four-week periods of HIIT, separated by 3 months of detraining.
METHODS


Thirteen healthy, recreationally active males (21±2 years) completed the study. Each four-week HIIT period included 40min of treadmill training 4 times/week. Each training session included four 7 min intervals: 4 minutes at 90-95% heart rate maximum (HR max ) and 3 minutes at 70-75% HR max . Vascular (FMD) and cardiorespiratory fitness (VO 2 max) assessments were conducted prior to and following each four-week training period.
RESULTS


Training resulted in significant improvements in VO 2 max (p<0.001). Training also improved FMD (p<0.001), with no differences between periods (p=0.394), even after controlling for changes in baseline diameter and the shear rate stimulus. There was a significant, moderate relationship between the change in FMD in HIIT period 1 vs period 2 (R 2 =0.493, p=0.011, ICC: 0.600, CV: 17.3%).
CONCLUSION


Consecutive periods of HIIT separated by detraining resulted in similar improvements in FMD at the group level, and individual FMD changes in period 1 of HIIT predicted FMD changes in response to period 2. Considered alongside substantial between participant variability in magnitude of FMD improvement, this suggests that there are reproducible, inter-individual differences in the potential to improve vascular function with HIIT.",2020,"Training also improved FMD (p<0.001), with no differences between periods (p=0.394), even after controlling for changes in baseline diameter and the shear rate stimulus.","['young males', 'Thirteen healthy, recreationally active males (21±2 years) completed the study']",['High intensity interval training (HIIT'],"['endothelial function', 'VO 2 max', 'shear rate stimulus', 'FMD', 'reproducibility of FMD responses', 'Vascular (FMD) and cardiorespiratory fitness (VO 2 max) assessments']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",13.0,0.0815282,"Training also improved FMD (p<0.001), with no differences between periods (p=0.394), even after controlling for changes in baseline diameter and the shear rate stimulus.","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Williams', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Canada.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Del Giudice', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Canada.""}, {'ForeName': 'Brendon James', 'Initials': 'BJ', 'LastName': 'Gurd', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Canada.""}, {'ForeName': 'Kyra Ellen', 'Initials': 'KE', 'LastName': 'Pyke', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Canada.""}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00054.2020']
2516,32790593,"Maximal strength training in patients with Parkinson's disease: Impact on efferent neural drive, force generating capacity, and functional performance.","Parkinson's disease (PD) is characterized by progressive neurological deterioration, typically accompanied by reductions in skeletal muscle force-generating capacity (FGC) and functional performance. Physical activity has the potential to counteract this debilitating outcome, however, it is elusive if high intensity strength training included in conventional treatment may improve results. Therefore, we randomly assigned 22 PD patients (74±9 years) to conventional rehabilitation with or without maximal strength training (MST) performed as leg press and chest press at ~90% of one repetition maximum (1RM), five times per week for four weeks. FGC, physical performance, and efferent neural drive assessed as evoked potentials (V-wave normalized to M-wave in m.soleus) were measured following training. Results revealed that only MST improved 1RM leg press (101±23 to 118±18kg) and chest press (36±15 to 41±15kg), plantar flexion maximal voluntary contraction (235±125 to 293±158N·m -1 ) and rate of force development (373±345 to 495±446N⋅m -1 ⋅s -1 ; all p<0.05; different from controls p<0.05). FGC-improvements were accompanied by an increased efferent neural drive to maximally contracting musculature (V/M-ratio: 0.17±0.12 to 0.24±0.15; p<0.05; different from controls p<0.05), improved physical performance (stair climbing: 21.0±9.2 to 14.4±5.2seconds; timed up and go: 7.8±3.3 to 6.2±2.5seconds; both p<0.05), and self-perceived improvement in health (3.1±0.5 to 2.6±0.9) and social activities functioning (2.2±1.0 to 1.5±1.1; both p<0.05). No changes were observed in the control group. In conclusion, this study shows that MST improves FGC, neuromuscular function, and functional performance, and advocate that high intensity strength training should be implemented as an adjunct therapy in the treatment of PD patients.",2020,"Results revealed that only MST improved 1RM leg press (101±23 to 118±18kg) and chest press (36±15 to 41±15kg), plantar flexion maximal voluntary contraction (235±125 to 293±158N·m -1 ) and rate of force development (373±345 to 495±446N⋅m -1 ⋅s -1 ; all p<0.05; different from controls p<0.05).","[""patients with Parkinson's disease"", ""Parkinson's disease (PD""]","['conventional rehabilitation with or without maximal strength training (MST) performed as leg press and chest press at ~90% of one repetition maximum (1RM', 'MST', 'Maximal strength training']","['MST improved 1RM leg press', 'FGC, physical performance, and efferent neural drive assessed as evoked potentials (V-wave normalized to M-wave in m.soleus', 'physical performance', 'FGC, neuromuscular function, and functional performance', 'plantar flexion maximal voluntary contraction (235±125 to 293±158N·m -1 ) and rate of force development', 'efferent neural drive to maximally contracting musculature', 'social activities functioning', 'self-perceived improvement in health']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205116', 'cui_str': 'Efferent'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C4301968', 'cui_str': 'v wave'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",22.0,0.0125312,"Results revealed that only MST improved 1RM leg press (101±23 to 118±18kg) and chest press (36±15 to 41±15kg), plantar flexion maximal voluntary contraction (235±125 to 293±158N·m -1 ) and rate of force development (373±345 to 495±446N⋅m -1 ⋅s -1 ; all p<0.05; different from controls p<0.05).","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Helgerud', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Norway.'}, {'ForeName': 'Simon Nørskov', 'Initials': 'SN', 'LastName': 'Thomsen', 'Affiliation': 'The Centre for Physical Activity Research (CFAS), University of Copenhagen, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hoff', 'Affiliation': 'Medical Rehabilitation Clinic, Myworkout (Norway), Norway.'}, {'ForeName': 'Arild', 'Initials': 'A', 'LastName': 'Strandbråten', 'Affiliation': 'Hokksund Medical Rehabilitation Center, Norway.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Leivseth', 'Affiliation': 'Department of Clinical Medicine, The Arctic University of Norway, Norway.'}, {'ForeName': 'Runar Jakobsen', 'Initials': 'RJ', 'LastName': 'Unhjem', 'Affiliation': 'Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Norway.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': 'Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Norway.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00208.2020']
2517,32790595,Variations in loop gain and arousal threshold during NREM sleep are affected by time of day over a 24 hour period in participants with obstructive sleep apnea.,"We investigated if time of day affects loop gain and the arousal threshold during non-rapid eye movement (NREM) sleep. Eleven males with obstructive sleep apnea completed a constant routine protocol comprised of sessions in the evening [10 PM (1) to 1 AM], morning (6 AM to 9 AM), afternoon (2 PM to 5 PM) and subsequent evening [10 PM (2) to 1 AM]. During each sleep session loop gain and the arousal threshold was measured during NREM sleep using a model-based approach. Loop gain and the arousal threshold were greater in the morning compared to both evening sessions [Loop gain: 10 PM (1) p = 0.01; 10 PM (2) p < 0.001] [Arousal threshold: 10 PM (1) p = 0.02; 10 PM (2) p = 0.001]. Moreover, no difference in loop gain and the arousal threshold existed between 10 PM (1) and 10 PM (2) (Loop gain: p = 0.27; Arousal threshold: p = 0.24). Loop gain was correlated to previously published measures of chemoreflex sensitivity (r = 0.72 & p = 0.045) and airway collapsibility (r = 0.77 & p = 0.02). We conclude that time of day modulates loop gain and the arousal threshold during NREM sleep. These modifications may contribute to increases in breathing instability in the morning compared to other periods in the day/night cycle. In addition, efficaciousness of treatments for obstructive sleep apnea that target loop gain and the arousal threshold may be modified by a rhythmicity of these variables.",2020,"Moreover, no difference in loop gain and the arousal threshold existed between 10 PM (1) and 10 PM (2) (Loop gain: p = 0.27; Arousal threshold: p = 0.24).","['participants with obstructive sleep apnea', 'Eleven males with obstructive sleep apnea']",[],"['Loop gain and the arousal threshold', 'breathing instability', 'chemoreflex sensitivity', 'loop gain and the arousal threshold', 'airway collapsibility']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],"[{'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}]",11.0,0.147017,"Moreover, no difference in loop gain and the arousal threshold existed between 10 PM (1) and 10 PM (2) (Loop gain: p = 0.27; Arousal threshold: p = 0.24).","[{'ForeName': 'Shipra', 'Initials': 'S', 'LastName': 'Puri', 'Affiliation': 'Department of Physiology, Wayne State University School of Medicine, United States.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'ElChami', 'Affiliation': 'Department of Physiology, Wayne State University School of Medicine, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shaheen', 'Affiliation': 'Department of Physiology, Wayne State University, United States.'}, {'ForeName': 'Blake', 'Initials': 'B', 'LastName': 'Ivers', 'Affiliation': 'Department of Physiology, Wayne State University School of Medicine, United States.'}, {'ForeName': 'Gino S', 'Initials': 'GS', 'LastName': 'Panza', 'Affiliation': 'Department of Physiology, Wayne State University School of Medicine, United States.'}, {'ForeName': 'M Safwan', 'Initials': 'MS', 'LastName': 'Badr', 'Affiliation': 'Department of Internal Medicine, Wayne State University School of Medicine, United States.'}, {'ForeName': 'Ho-Sheng', 'Initials': 'HS', 'LastName': 'Lin', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Wayne State University, United States.'}, {'ForeName': 'Jason H', 'Initials': 'JH', 'LastName': 'Mateika', 'Affiliation': 'Department of Physiology, Wayne State University, United States.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00376.2020']
2518,32790616,Microneedling and Platelet-Rich Plasma versus Microneedling and 5% Topical Minoxidil Therapy in Male Pattern Hair Loss.,"A 33-year-old man, Hamilton-Norwood criteria stage III, and a 34-year-old man, Hamilton-Norwood criteria stage IV, were enrolled in this study and were allocated to two different treatments. The first patient was treated with microneedling and platelet-rich plasma (PRP), while the second patient was treated with microneedling and 5% topical minoxidil. Each patient underwent eight sessions of microneedling treatment, with 2 weeks interval for the first 2 months and 4 weeks interval for the next 4 months. We evaluated the patients at the end of 6th month. Significant improvements were observed earlier on the patient who underwent microneedling and PRP treatment with high overall patient satisfaction. There were no serious side effects observed.",2020,There were no serious side effects observed.,"['A 33-year-old man, Hamilton-Norwood criteria stage III, and a 34-year-old man, Hamilton-Norwood criteria stage IV', 'Male Pattern Hair Loss']","['Microneedling and Platelet-Rich Plasma versus Microneedling and 5% Topical Minoxidil Therapy', 'microneedling and 5% topical minoxidil']",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0730881', 'cui_str': 'Regaine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.0166506,There were no serious side effects observed.,"[{'ForeName': 'Maria Mayfinna', 'Initials': 'MM', 'LastName': 'Gozali', 'Affiliation': 'Department of Dermatology and Venereology Faculty of Medicine, Sriwijaya University, Dr. Mohammad Hoesin General Hospital, Palembang, South Sumatera, Indonesia; mayfinna.gozali@gmail.com.'}, {'ForeName': 'Yuli', 'Initials': 'Y', 'LastName': 'Kurniawati', 'Affiliation': 'Department of Dermatology and Venereology Faculty of Medicine, Sriwijaya University, Dr. Mohammad Hoesin General Hospital, Palembang, South Sumatera, Indonesia.'}, {'ForeName': 'Sarah Diba', 'Initials': 'SD', 'LastName': 'Zulkarnain', 'Affiliation': 'Department of Dermatology and Venereology Faculty of Medicine, Sriwijaya University, Dr. Mohammad Hoesin General Hospital, Palembang, South Sumatera, Indonesia.'}]",Skinmed,[]
2519,32790671,Increasing adverse drug reaction reporting-How can we do better?,"Adverse drug reactions (ADRs) are associated with morbidity and mortality worldwide. Although national systems for reporting ADRs exist there is a low reporting rate. The aim of the current study was to evaluate an intervention plan for improving ADRs reporting among medical professionals (physicians and nurses). A multicentre intervention study was conducted, in which one medical centre was randomly assigned to the intervention group and two medical centres to the control group. The study consisted of 3 phases: baseline data collection, intervention and follow-up of the reporting rate. The questionnaire that was filled in at base line and at the end of study, contained questions about personal/professional demographic variables, and statements regarding knowledge of and behaviour toward ADRs reporting. The intervention program consisted of posters, lectures, distant electronic learning and reminders. An increase in the number of ADRs reports was noted in the intervention group (74 times higher than in the control group) during the intervention period, which was gradually decreased with as the study progressed (adjusted O.R = 74.1, 95% CI = 21.11-260.1, p<0.001). The changes in the ""knowledge related to behaviour"" (p = 0.01) and in the ""behaviour related to reporting"" (p<0.001) score was significantly higher in the intervention group. Specialist physicians and nurses (p<0.001), fulfilling additional positions (p<0.001) and those working in other places (p = 0.05) demonstrated a high rate of report. Lectures were preferable as a method to encourage ADRs reporting. The most convenient reporting tools were telephone and online reporting. Thus, implementation and maintenance of a continuous intervention program, by a pharmacovigilance specialist staff member, will improve ADRs reporting rates.",2020,"The changes in the ""knowledge related to behaviour"" (p = 0.01) and in the ""behaviour related to reporting"" (p<0.001) score was significantly higher in the intervention group.",['medical professionals (physicians and nurses'],"['posters, lectures, distant electronic learning and reminders']","['Adverse drug reactions (ADRs', 'number of ADRs reports']","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0376675', 'cui_str': 'Posters'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",,0.0325042,"The changes in the ""knowledge related to behaviour"" (p = 0.01) and in the ""behaviour related to reporting"" (p<0.001) score was significantly higher in the intervention group.","[{'ForeName': 'Miri', 'Initials': 'M', 'LastName': 'Potlog Shchory', 'Affiliation': 'Department of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Lee H', 'Initials': 'LH', 'LastName': 'Goldstein', 'Affiliation': 'Clinical Pharmacology Unit, Haemek Medical Center, Afula affiliated to The Bruce Rapapport School of Medicine, Technion, Haifa, Israel.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Arcavi', 'Affiliation': 'Clinical Pharmacology Unit, Kaplan Medical Center, Hebrew University and Hadassah Medical School, Rehovot, Jerusalem, Israel.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Shihmanter', 'Affiliation': 'Clinical Pharmacology Unit, Kaplan Medical Center, Hebrew University and Hadassah Medical School, Rehovot, Jerusalem, Israel.'}, {'ForeName': 'Matitiahu', 'Initials': 'M', 'LastName': 'Berkovitch', 'Affiliation': 'Clinical Pharmacology Unit, Shamir Medical Center (Assaf Harofeh), Zerifin, Affiliated to Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Levy', 'Affiliation': 'Department of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}]",PloS one,['10.1371/journal.pone.0235591']
2520,32790699,Replicating and extending the effects of auditory religious cues on dishonest behavior.,"Although scientists agree that replications are critical to the debate on the validity of religious priming research, religious priming replications are scarce. This paper attempts to replicate and extend previously observed effects of religious priming on ethical behavior. We test the effect of religious instrumental music on individuals' ethical behavior with university participants (N = 408) in the Czech Republic, Japan, and the US. Participants were randomly assigned to listen to one of three musical tracks (religious, secular, or white noise) or to no music (control) for the duration of a decision-making game. Participants were asked to indicate which side of a vertically-bisected computer screen contained more dots and, in every trial, indicating that the right side of the screen had more dots earned participants the most money (irrespective of the number of dots). Therefore, participants were able to report dishonestly to earn more money. In agreement with previous research, we did not observe any main effects of condition. However, we were unable to replicate a moderating effect of self-reported religiosity on the effects of religious music on ethical behavior. Nevertheless, further analyses revealed moderating effects for ritual participation and declared religious affiliation congruent with the musical prime. That is, participants affiliated with a religious organization and taking part in rituals cheated significantly less than their peers when listening to religious music. We also observed significant differences in cheating behavior across samples. On average, US participants cheated the most and Czech participants cheated the least. We conclude that normative conduct is, in part, learned through active membership in religious communities and our findings provide further support for religious music as a subtle, moral cue.",2020,"On average, US participants cheated the most and Czech participants cheated the least.","[""individuals' ethical behavior with university participants (N = 408) in the Czech Republic, Japan, and the US""]","['religious instrumental music', 'musical tracks (religious, secular, or white noise) or to no music (control) for the duration of a decision-making game', 'auditory religious cues']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C0206578', 'cui_str': 'Czech republic'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0557075', 'cui_str': 'Has religious belief'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]",[],408.0,0.0394338,"On average, US participants cheated the most and Czech participants cheated the least.","[{'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Nichols', 'Affiliation': 'Questrom School of Business, Boston University, Boston, MA, United States of America.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lang', 'Affiliation': 'LEVYNA Laboratory for the Experimental Research of Religion, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Kavanagh', 'Affiliation': 'Institute of Cognitive & Evolutionary Anthropology, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Radek', 'Initials': 'R', 'LastName': 'Kundt', 'Affiliation': 'LEVYNA Laboratory for the Experimental Research of Religion, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Yamada', 'Affiliation': 'Department of Behavioral Science, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ariely', 'Affiliation': 'Social Sciences Research Institute, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Mitkidis', 'Affiliation': 'Social Sciences Research Institute, Duke University, Durham, NC, United States of America.'}]",PloS one,['10.1371/journal.pone.0237007']
2521,32790844,"Efficacy of folinic acid rescue following MTX GVHD prophylaxis: results of a double-blind, randomized, controlled study.","The use of methotrexate (MTX) for graft-versus-host disease (GVHD) prophylaxis is associated with increased rates of organ-specific toxicities. Despite limited data, the European Society for Blood and Marrow Transplantation-European LeukemiaNet working group recommend the use of folinic acid (FA) rescue to reduce MTX toxicity after allogeneic hematopoietic cell transplantation (allo-HCT). In a multicenter, double-blind, randomized, controlled trial, we explored whether FA rescue reduces MTX-induced toxicity. We enrolled patients undergoing allo-HCT with myeloablative conditioning with peripheral blood stem cell grafts, with GVHD prophylaxis consisting of cyclosporine and MTX. Patients were randomized to receive FA or placebo starting 24 hours after each MTX dose and continuing over 24 hours in 3 to 4 divided doses. The primary end point was the rate of grades 3 and 4 oral mucositis. After enrollment of 52 patients (FA, n = 28; placebo, n = 24), preplanned interim analysis revealed similar rates of grade 3 and 4 (46.6% vs 45.8%; P = .97) and grades 1 to 4 (83.3% vs 77.8%; P = .65) oral mucositis. With a median follow-up of 17 (range, 4.5-50) months, there was no difference in the rates of acute and chronic GVHD, disease relapse, nonrelapse mortality, and overall survival. These interim results did not support continuation of the study. We conclude that FA rescue after MTX GVHD prophylaxis does not decrease regimen-related toxicity or affect transplantation outcomes. This study was registered at clinicaltrials.gov as #NCT02506231.",2020,"With a median follow-up of 17 (range, 4.5-50) months, there was no difference in the rates of acute and chronic GVHD, disease relapse, nonrelapse mortality, and overall survival.","['enrolled patients undergoing allo-HCT with myeloablative conditioning with peripheral blood stem cell grafts, with GVHD prophylaxis consisting of']","['FA or placebo', 'methotrexate (MTX', 'folinic acid (FA', 'placebo', 'cyclosporine and MTX', 'FA', 'MTX GVHD prophylaxis', 'folinic acid']","['MTX toxicity', 'MTX-induced toxicity', 'rates of acute and chronic GVHD, disease relapse, nonrelapse mortality, and overall survival', 'rate of grades 3 and 4 oral mucositis', 'oral mucositis', 'rates of organ-specific toxicities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0242602', 'cui_str': 'Peripheral blood stem cell graft'}, {'cui': 'C0018133', 'cui_str': 'Graft versus host disease'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0018133', 'cui_str': 'Graft versus host disease'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0568062', 'cui_str': 'Methotrexate poisoning'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease'}, {'cui': 'C0277556', 'cui_str': 'Recurrent disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",,0.615281,"With a median follow-up of 17 (range, 4.5-50) months, there was no difference in the rates of acute and chronic GVHD, disease relapse, nonrelapse mortality, and overall survival.","[{'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Yeshurun', 'Affiliation': 'Institution of Hematology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Rozovski', 'Affiliation': 'Institution of Hematology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Pasvolsky', 'Affiliation': 'Institution of Hematology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Ofir', 'Initials': 'O', 'LastName': 'Wolach', 'Affiliation': 'Institution of Hematology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Ram', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Odelia', 'Initials': 'O', 'LastName': 'Amit', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Tsila', 'Initials': 'T', 'LastName': 'Zuckerman', 'Affiliation': 'Rambam Medical Center, Haifa, Israel.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Pek', 'Affiliation': 'Institution of Hematology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Maly', 'Initials': 'M', 'LastName': 'Rubinstein', 'Affiliation': 'Institution of Hematology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Sela-Navon', 'Affiliation': 'Institution of Hematology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Raanani', 'Affiliation': 'Institution of Hematology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Liat', 'Initials': 'L', 'LastName': 'Shargian-Alon', 'Affiliation': 'Institution of Hematology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.'}]",Blood advances,['10.1182/bloodadvances.2020002039']
2522,32790845,Recombinant human thrombopoietin promotes platelet engraftment after umbilical cord blood transplantation.,"Delayed platelet engraftment is a common complication after umbilical cord blood transplantation (UCBT) accompanied by increased transplant-related complications or death. This study was designed to determine the safety and efficacy of recombinant human thrombopoietin (rhTPO) in promoting platelet engraftment after UCBT. A total of 120 patients scheduled to receive UCBT were randomly assigned to the rhTPO group (300 U/kg once daily from days 14 to 28 after UCBT, n = 60) or the control group (n = 60). The primary outcome was the 60-day cumulative incidence of platelet engraftment after single-unit cord blood transplantation. The 60-day cumulative incidence of platelet engraftment (platelet count ≥20 × 109/L) and the 120-day cumulative incidence of platelet recovery (platelet count ≥50 × 109/L) were both significantly higher in the rhTPO group than in the control group (83.1% vs 66.7%, P = .020; and 81.4% vs 65.0%, P = .032, respectively). In addition, the number of required platelet infusions was significantly lower in the rhTPO group than in the control group (6 vs 8 units, respectively; P = .026). The cumulative incidence of neutrophil engraftment and the probability of 2-year overall survival, disease-free survival, and graft-versus-host disease-free relapse-free survival did not differ between the 2 groups. Other transplant-related outcomes and complications did not differ between the 2 groups, and no severe adverse effects were observed in patients receiving rhTPO. This study demonstrated that rhTPO is well tolerated in patients and could effectively promote platelet engraftment after UCBT. This study was registered on the Chinese Clinical Trial Registry (http://www.chictr.org.cn/index.aspx) as ChiCTR-IPR-16009357.",2020,"Other transplant-related outcomes and complications did not differ between the 2 groups, and no severe adverse effects were observed in patients receiving rhTPO.","['umbilical cord blood transplantation', '120 patients scheduled to receive']","['recombinant human thrombopoietin (rhTPO', 'UCBT', 'Recombinant human thrombopoietin', 'rhTPO']","['120-day cumulative incidence of platelet recovery (platelet count ≥50 × 109/L', 'Delayed platelet engraftment', 'cumulative incidence of neutrophil engraftment and the probability of 2-year overall survival, disease-free survival, and graft-versus-host disease-free relapse-free survival', 'number of required platelet infusions', '60-day cumulative incidence of platelet engraftment', 'severe adverse effects', '60-day cumulative incidence of platelet engraftment after single-unit cord blood transplantation']","[{'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040052', 'cui_str': 'Thrombopoietin'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0018133', 'cui_str': 'Graft versus host disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]",120.0,0.0992311,"Other transplant-related outcomes and complications did not differ between the 2 groups, and no severe adverse effects were observed in patients receiving rhTPO.","[{'ForeName': 'Baolin', 'Initials': 'B', 'LastName': 'Tang', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Huilan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Siqi', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Kaidi', 'Initials': 'K', 'LastName': 'Song', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Xuhan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Yao', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Ning', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Guangyu', 'Initials': 'G', 'LastName': 'Sun', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Jiehui', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Long', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Zimin', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}]",Blood advances,['10.1182/bloodadvances.2020002257']
2523,32790904,Vortioxetine versus other antidepressants in the treatment of Burning Mouth Syndrome: an open-label randomized trial.,"OBJECTIVES


This randomized open-label trial compared the efficacy and tolerability of vortioxetine (15 mg/daily) with different antidepressants in the treatment of patients with Burning Mouth Syndrome (BMS).
METHODS


150 BMS patients were randomized into five groups and treated with either vortioxetine, paroxetine (20 mg/ daily), sertraline (50 mg/ daily), escitalopram (10 mg/ daily) or duloxetine (60 mg/ daily).The Visual Analogue Scale (VAS), Total Pain Rating Index (T-PRI), Hamilton Rating Scales for Depression (HAM-D) and Anxiety (HAM-A) and Clinical Global Impression Improvement (CGI-I) and Efficacy scales (CGI-E) were performed at baseline and after 2, 4, 6 and 12 months of treatment. Any Adverse Events (AEs) were tabulated for each group. Descriptive statistics, including the Kruskal-Wallis non-parametric test and the Friedman non-parametric test for median comparisons between different times, were used.
RESULTS


All the antidepressants (AD) were associated with a significant decrease in the VAS, T-PRI, HAM-A, HAM-D, CGI-I and CGI-E scores in the long-term (P < .001). However, the response rate of the Vortioxetine group showed a significant reduction after six months. The medians, after 6-months, were: VAS 0.0; T-PRI 2.0; HAM-A 7.0; HAM-D 7.0, CGI-I 1.0 and CGIE 1.0 with a lower incidence of AEs (P < .019).
CONCLUSION


Vortioxetine was efficacious with a shorter latency of action and fewer AEs compared with other ADs.",2020,"All the antidepressants (AD) were associated with a significant decrease in the VAS, T-PRI, HAM-A, HAM-D, CGI","['patients with Burning Mouth Syndrome (BMS', '150 BMS patients', 'Burning Mouth Syndrome']","['vortioxetine', 'vortioxetine, paroxetine', 'sertraline', 'Vortioxetine', 'escitalopram (10 mg/ daily) or duloxetine']","['I and CGI-E scores', 'Visual Analogue Scale (VAS), Total Pain Rating Index (T-PRI), Hamilton Rating Scales for Depression (HAM-D) and Anxiety (HAM-A) and Clinical Global Impression Improvement (CGI-I) and Efficacy scales (CGI-E', 'VAS, T-PRI, HAM-A, HAM-D, CGI', 'efficacy and tolerability', 'response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006430', 'cui_str': 'Burning mouth syndrome'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C0070122', 'cui_str': 'Paroxetine'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0245561', 'cui_str': 'duloxetine'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",150.0,0.0555323,"All the antidepressants (AD) were associated with a significant decrease in the VAS, T-PRI, HAM-A, HAM-D, CGI","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Adamo', 'Affiliation': 'University Federico II of Naples, Department of Neurosciences, Reproductive and Odontostomatological Sciences, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pecoraro', 'Affiliation': 'University Federico II of Naples, Department of Neurosciences, Reproductive and Odontostomatological Sciences, Italy.'}, {'ForeName': 'Noemi', 'Initials': 'N', 'LastName': 'Coppola', 'Affiliation': 'University Federico II of Naples, Department of Neurosciences, Reproductive and Odontostomatological Sciences, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Calabria', 'Affiliation': 'University Federico II of Naples, Department of Neurosciences, Reproductive and Odontostomatological Sciences, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Aria', 'Affiliation': 'University Federico II of Naples, Department of Economics, Italy.'}, {'ForeName': 'Michele Davide', 'Initials': 'MD', 'LastName': 'Mignogna', 'Affiliation': 'University Federico II of Naples, Department of Neurosciences, Reproductive and Odontostomatological Sciences, Italy.'}]",Oral diseases,['10.1111/odi.13602']
2524,32790913,Non-impacted tooth extractions and antibiotic treatment: a RCT study.,"OBJECTIVES


A controlled, single-blind, randomized clinical trial was performed to evaluate usefulness of antibiotics in preventing pain and complications after tooth extractions and benefits of probiotics in reducing gastro-intestinal symptoms associated with antibiotic therapy MATERIALS AND METHODS: 159 patients were enrolled in this trial. After tooth extractions, patients were allocated to one of the groups: group 1 received post-operatively amoxicillin + clavulanic acid; group 2 received the same antibiotic therapy with an adjunctive probiotic treatment; group 3 received neither antibiotics nor probiotics. Follow-up visits were planned at 7, 14 and 21 days after tooth extractions (T1, T2 and T3) and parameters assessed were pain, presence of abscess, oedema, fever, alveolitis, trismus, pain, difficulty in daily routine activities and gastro-intestinal symptoms.
RESULTS


The number of patients reporting pain at T1 was significantly higher in the control group when compared to group 2 (p=0.016), whilst no difference for pain intensity was observed between groups. No surgical site infection was observed in any of the groups. Intestinal symptoms seemed to be tackled by probiotic administration.
CONCLUSIONS


Pain was the most important symptom in the control group. Antibiotics were not necessary after non-impacted tooth extractions and probiotics can reduce intestinal symptoms associated with antibiotics.",2020,"The number of patients reporting pain at T1 was significantly higher in the control group when compared to group 2 (p=0.016), whilst no difference for pain intensity was observed between groups.",[' 159 patients were enrolled in this trial'],"['antibiotics', 'antibiotic therapy with an adjunctive probiotic treatment; group 3 received neither antibiotics nor probiotics', 'post-operatively amoxicillin + clavulanic acid']","['gastro-intestinal symptoms', 'Intestinal symptoms', 'pain, presence of abscess, oedema, fever, alveolitis, trismus, pain, difficulty in daily routine activities and gastro-intestinal symptoms', 'pain intensity', 'pain and complications', 'surgical site infection', 'number of patients reporting pain at T1']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0054066', 'cui_str': 'Amoxicillin and clavulanate'}]","[{'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0549493', 'cui_str': 'Alveolitis'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",159.0,0.0839699,"The number of patients reporting pain at T1 was significantly higher in the control group when compared to group 2 (p=0.016), whilst no difference for pain intensity was observed between groups.","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cinquini', 'Affiliation': 'University of Pisa, Department of Surgical, Medical, Molecular and Critical Area Pathology, University-Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Marchionni', 'Affiliation': 'University of Pisa, Department of Surgical, Medical, Molecular and Critical Area Pathology, University-Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Derchi', 'Affiliation': 'University of Pisa, Department of Surgical, Medical, Molecular and Critical Area Pathology, University-Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Miccoli', 'Affiliation': 'University of Pisa, Department of Clinical and Experimental Medicine, University-Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Gabriele', 'Affiliation': 'University of Pisa, Department of Surgical, Medical, Molecular and Critical Area Pathology, University-Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Barone', 'Affiliation': 'University of Pisa, Department of Surgical, Medical, Molecular and Critical Area Pathology, University-Hospital of Pisa, Pisa, Italy.'}]",Oral diseases,['10.1111/odi.13607']
2525,32790921,Histological and histomorphometrical outcome after lateral GBR augmentation of the mandible with different ratios of deproteinized bovine bone mineral and autogenous bone. A preclinical in vivo study.,"OBJECTIVE


To test the hypotheses of no differences in (I) percentage of bone (POB), non-mineralized tissue (NMT) and deproteinized bovine bone mineral (DBBM), and (II) ingrowth of mineralized bone after lateral guided bone regeneration (GBR) augmentation of the mandible with different ratios of DBBM and particulate autogenous bone (PAB) at different time points.
MATERIAL AND METHODS


Twenty-four minipigs were randomly allocated into three groups. Lateral augmentation in 96 sites (4 in each animal) was performed unilaterally with a standardized quantity of grafting material in each animal with different ratios of DBBM and PAB (50:50, 75:25, 100:0) and autogenous bone block in combination with DBBM and covered with a collagen membrane. The percentage of different tissues in the graft and ingrowth of mineralized bone was assessed by histomorphometric and histological analyses after 10, 20 and 30 weeks, respectively.
RESULTS


The POB was 54% (50:50), 50% (75:25), and 48% (100:0) after 10 weeks, 60% (50:50), 61% (75:25), and 60% (100:0) after 20 weeks, 63% (50:50), 62% (75:25), and 62% (100:0) after 30 weeks. There was no significant difference between the groups at any time points. There was a significant increase in POB and a significant decrease in NMT for 75:25 and 100:0 from 10 to 30 weeks. All ratios demonstrated a non-complete ingrowth of mineralized bone into the graft after 10 weeks and complete mineralization after 30 weeks.
CONCLUSION


Within the limitations of the present study, it seems like addition of autogenous bone to DBBM for LRA did not affect the bone formation nor graft incorporation after 10 to 30 weeks of healing. However, a prolonged healing time seems to result in an increased POB for all ratios.",2020,"All ratios demonstrated a non-complete ingrowth of mineralized bone into the graft after 10 weeks and complete mineralization after 30 weeks.
",['Twenty-four minipigs'],"['autogenous bone block in combination with DBBM and covered with a collagen membrane', 'deproteinized bovine bone mineral and autogenous bone']","['bone formation nor graft incorporation', 'bone (POB), non-mineralized tissue (NMT) and deproteinized bovine bone mineral (DBBM), and (II) ingrowth of mineralized bone', 'POB', 'NMT']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0039011', 'cui_str': 'Miniature Swine'}]","[{'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C1293164', 'cui_str': 'Bone block procedure'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}]","[{'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0243126', 'cui_str': 'incorporation'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}]",24.0,0.0558712,"All ratios demonstrated a non-complete ingrowth of mineralized bone into the graft after 10 weeks and complete mineralization after 30 weeks.
","[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Aludden', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Mordenfeld', 'Affiliation': 'Plastic and Oral & Maxillofacial Surgery, Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Christer', 'Initials': 'C', 'LastName': 'Dahlin', 'Affiliation': 'Department of Biomaterials, BIOMATCELL VINN Excellence center, Institute for Surgical Science, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Hallman', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Gävle County Hospital, Gävle, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Starch-Jensen', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Aalborg University Hospital, Aalborg, Denmark.'}]",Clinical oral implants research,['10.1111/clr.13649']
2526,32790955,Proprioceptive neuromuscular facilitation compared to conventional physiotherapy for adults with traumatic upper brachial plexus injury: A protocol for a randomized clinical trial.,"BACKGROUND


Traumatic upper plexus injury affects daily living activities performance and participation of individuals. Physical therapy treatment has a fundamental role on functional recovery, but it is still an unexplored and challenging field.
AIM


To develop a protocol to evaluate the efficacy of Proprioceptive Neuromuscular Facilitation (PNF) compared to conventional physiotherapy (CPT group) on functionality and quality of life.
METHODS


A committee was formed by four physical therapists to develop the treatment protocol. A Delphi study was carried out in order to quantify the level of agreement. A protocol for a randomized controlled trial was proposed to evaluate the effectiveness of the protocol in improving functionality and quality of life, according Consolidated Standards of Reporting Trials. Participants will be randomly assigned (1:1) to PNF or CPT group and two weekly sessions will be carried out for 12 months postsurgery, with a three-month follow-up. The main outcome measurements are: upper limb functionality, quality of life, range of motion, muscle strength, tactile sensitivity, and pain, which will be assessed at baseline, on the 6th, 9th, and 12th months postsurgery.
RESULT


A PNF protocol was developed for traumatic upper brachial plexus injury, consisting of 11 illustrated exercises, three for immediate postoperative and eight for postoperative. Biomechanical objectives, observations, positions of patients and therapists and PNF principles, procedures and techniques have been described. An 80% agreement on all items in the first round of the Delphi study was achieved.
CONCLUSION


A protocol based on the PNF-concept was developed with the aim of improving the functionality and quality of life of individuals undergoing nerve transfer after traumatic injury to the upper plexus. The detailed description of a physical therapy treatment protocol through an appropriate method will allow its use in clinical practice and in future studies with this population.",2020,"A protocol for a randomized controlled trial was proposed to evaluate the effectiveness of the protocol in improving functionality and quality of life, according Consolidated Standards of Reporting Trials.","['individuals', 'adults with traumatic upper brachial plexus injury', 'individuals undergoing nerve transfer after traumatic injury to the upper plexus']","['Proprioceptive Neuromuscular Facilitation (PNF', 'PNF or CPT', 'Proprioceptive neuromuscular facilitation', 'conventional physiotherapy', 'conventional physiotherapy (CPT group', 'Physical therapy treatment']","['upper limb functionality, quality of life, range of motion, muscle strength, tactile sensitivity, and pain, which will be assessed at baseline, on the 6th, 9th, and 12th months postsurgery', 'functionality and quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0161446', 'cui_str': 'Injury of brachial plexus'}, {'cui': 'C0079896', 'cui_str': 'Neurotization'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]","[{'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0949766', 'cui_str': 'Physical therapy procedure'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",,0.0825475,"A protocol for a randomized controlled trial was proposed to evaluate the effectiveness of the protocol in improving functionality and quality of life, according Consolidated Standards of Reporting Trials.","[{'ForeName': 'Alessandra Carolina de Santana', 'Initials': 'ACS', 'LastName': 'Chagas', 'Affiliation': 'Department of Physiotherapy, Federal University of Pernambuco, Recife, Brazil.'}, {'ForeName': 'Débora', 'Initials': 'D', 'LastName': 'Wanderley', 'Affiliation': 'Department of Physiotherapy, Federal University of Pernambuco, Recife, Brazil.'}, {'ForeName': 'Paulo José Moté', 'Initials': 'PJM', 'LastName': 'Barboza', 'Affiliation': 'Integrated Rehabilitation and Aquatic Therapy Center, Rio de Janeiro, Brazil.'}, {'ForeName': 'José Vicente Pereira', 'Initials': 'JVP', 'LastName': 'Martins', 'Affiliation': 'Department of Physiotherapy, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Alexa Alves', 'Initials': 'AA', 'LastName': 'de Moraes', 'Affiliation': 'Department of Physiotherapy, Federal University of Pernambuco, Recife, Brazil.'}, {'ForeName': 'Fernando Henrique Morais', 'Initials': 'FHM', 'LastName': 'de Souza', 'Affiliation': 'Peripheral Nerve Neurosurgery Clinic of the Hospital da Restauração, Recife, Brazil.'}, {'ForeName': 'Daniella Araújo', 'Initials': 'DA', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Physiotherapy, Federal University of Pernambuco, Recife, Brazil.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1873']
2527,32791011,The Impact of a Ketogenic Dietary Intervention on the Quality of Life of Stage II and III Cancer Patients: A Randomized Controlled Trial in the Caribbean.,"INTRODUCTION


This study sought to determine the impact of a ketogenic dietary intervention on the quality of life of stage II and III cancer patients.
METHODS


A randomized controlled trial was implemented whereby patients in the treatment group followed a modified ketogenic diet (KD) utilizing medium chained triglyceride fats during a four-month period, while the control group followed an institutionalized standard traditional diet. Quality of life and mental health status was assessed using The European Organization for Research and Treatment of Cancer current core questionnaire and The Patient Health Questionnaire. Intervention effects were assessed using repeated measures ANCOVA and multiple linear regression models.
RESULTS


The quality of life and mental health of the cancer patients in the treatment group were greatly increased and improved due to the utilization of the diet. Most of the persons in the treatment group attained and maintained ketosis after 2 weeks. Age, gender, and state of the disease seemed to affect the keto-adaptation period in terms of the time taken to keto-adapt.
CONCLUSION


The KD was suitable for stage II and III cancer patients in improving their quality of life, nutritional, functional, and psychosocial statuses.",2020,"The KD was suitable for stage II and III cancer patients in improving their quality of life, nutritional, functional, and psychosocial statuses.","['and III Cancer Patients', 'and III cancer patients']","['modified ketogenic diet (KD) utilizing medium chained triglyceride fats', 'Ketogenic Dietary Intervention', 'ketogenic dietary intervention', 'institutionalized standard traditional diet']","['quality of life and mental health', 'maintained ketosis', 'quality of life of stage II', 'quality of life, nutritional, functional, and psychosocial statuses', 'Quality of life and mental health status', 'Quality of Life of Stage II']","[{'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0022638', 'cui_str': 'Ketosis'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0337459', 'cui_str': 'Psychosocial status'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.0276628,"The KD was suitable for stage II and III cancer patients in improving their quality of life, nutritional, functional, and psychosocial statuses.","[{'ForeName': 'Eden', 'Initials': 'E', 'LastName': 'Augustus', 'Affiliation': 'The George Alleyne Chronic Disease Research Centre, Caribbean Institute for Health Research (CAIHR), The University of the West Indies, Bridgetown, Barbados, West Indies.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Granderson', 'Affiliation': 'Faculty of Food and Agriculture, Department of Agricultural Economics and Extension, The University of the West Indies, Trinidad, West Indies.'}, {'ForeName': 'Kern D', 'Initials': 'KD', 'LastName': 'Rocke', 'Affiliation': 'The George Alleyne Chronic Disease Research Centre, Caribbean Institute for Health Research (CAIHR), The University of the West Indies, Bridgetown, Barbados, West Indies.'}]",Nutrition and cancer,['10.1080/01635581.2020.1803930']
2528,32791030,Examining HSD3B1 as a possible biomarker to detect prostate cancer patients who are likely to progress on ADT.,The Chemohormonal Therapy vs Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED) was a randomized phase III trial that evaluated the outcomes of men with metastatic prostate cancer who received castration with or without docetaxel. Patients from this trial were genotyped in a recent study to detect HSD3B1 variance and to determine 2-y freedom from castration-resistant prostate cancer as well as overall survival. The results of this study identified HSD3B1 as a possible biomarker that can be used to predict response to therapy in patients with metastatic disease.,2020,The Chemohormonal Therapy vs Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED) was a randomized phase III trial that evaluated the outcomes of men with metastatic prostate cancer who received castration with or without docetaxel.,"['patients with metastatic disease', 'men with metastatic prostate cancer who received', 'prostate cancer patients who are likely to progress on ADT']",['castration with or without docetaxel'],['overall survival'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0936223', 'cui_str': 'Prostate cancer metastatic'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}]","[{'cui': 'C0007344', 'cui_str': 'Gonadectomy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.034008,The Chemohormonal Therapy vs Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED) was a randomized phase III trial that evaluated the outcomes of men with metastatic prostate cancer who received castration with or without docetaxel.,"[{'ForeName': 'Whitney F', 'Initials': 'WF', 'LastName': 'Handy', 'Affiliation': 'Bernard J. Dunn School of Pharmacy, Shenandoah University , Fairfax, VA, USA.'}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Schmidt', 'Affiliation': 'Clinical Pharmacology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health , Bethesda, MD, USA.'}, {'ForeName': 'Douglas K', 'Initials': 'DK', 'LastName': 'Price', 'Affiliation': 'Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health , Bethesda, MD, USA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Figg', 'Affiliation': 'Clinical Pharmacology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health , Bethesda, MD, USA.'}]",Cancer biology & therapy,['10.1080/15384047.2020.1796195']
2529,32797292,"A study protocol for a randomized controlled trial of a cross-systems service delivery model to improve identification and care for HIV, STIs and substance use among justice-involved young adults.","BACKGROUND


Justice-involved young adults (JIYA) aged 18-24 are at significant risk for HIV and problematic substance use (SU) but are unlikely to know their HIV status or be linked to HIV or SU treatment and care. Intensive efforts to increase screening and improve linkage to HIV and SU services for JIYA are needed that address youth as well as justice and health/behavioral health system-level barriers.
METHODS


MoveUp is a four-session intervention that integrates evidence-based protocols to promote HIV and STI testing, HIV and SU behavioral risk reduction and engagement in treatment for JIYA. MoveUp is delivered onsite at an alternative sentencing program (ASP) by HIV testing outreach workers from a youth-focused medical and HIV treatment program. N = 450 youth are randomized following baseline assessment into two groups: MoveUp or standard of care. Youth are followed for 12 months following the intervention; unprotected sexual behavior, substance use, HIV and STI testing as well as treatment linkage will be assessed at 3, 6, 9 and 12-months.
DISCUSSION


This study is one of the first to systematically test an integrated screen/testing, prevention intervention and linkage-to-care services program (MoveUp), using evidence-based approaches to address the overlapping HIV/STI and substance use epidemics in JIYA by providing on-site services to identify HIV/STI and SU risk and treatment need within justice-settings as well as linkage to services in the community. This approach, capitalizing on health and justice partnerships, represents an innovation that can capitalize on missed opportunities for engaging JIYA in health care.",2020,"Youth are followed for 12 months following the intervention; unprotected sexual behavior, substance use, HIV and STI testing as well as treatment linkage will be assessed at 3, 6, 9 and","['Justice-involved young adults (JIYA) aged 18-24 are at significant risk for HIV and problematic substance use (SU', 'N\u2009=\u2009450 youth', 'justice-involved young adults']","['MoveUp or standard of care', 'integrated screen/testing, prevention intervention and linkage-to-care services program (MoveUp']",[],"[{'cui': 'C0022437', 'cui_str': 'Justice'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0366743,"Youth are followed for 12 months following the intervention; unprotected sexual behavior, substance use, HIV and STI testing as well as treatment linkage will be assessed at 3, 6, 9 and","[{'ForeName': 'Katherine S', 'Initials': 'KS', 'LastName': 'Elkington', 'Affiliation': 'Department of Psychiatry, Columbia University and the New York State Psychiatric Institute, New York, NY, USA. ke2143@cumc.columbia.edu.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': ""O'Grady"", 'Affiliation': 'University of Connecticut, School of Medicine Department of Public Health Sciences, 263 Farmington Avenue, Farmington, CT, 06030-6325, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Tross', 'Affiliation': 'Department of Psychiatry, Columbia University and the New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Wilson', 'Affiliation': 'Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Watkins', 'Affiliation': 'Department of Psychiatry, Columbia University and the New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Lenore', 'Initials': 'L', 'LastName': 'Lebron', 'Affiliation': 'Center for Court Innovation, New York, NY, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Cohall', 'Affiliation': 'Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Alwyn', 'Initials': 'A', 'LastName': 'Cohall', 'Affiliation': 'Mailman School of Public Health, Columbia University, New York, NY, USA.'}]",Health & justice,['10.1186/s40352-020-00121-7']
2530,32797324,Influence of postoperative complications on long-term outcome after oncologic lung resection surgery. Substudy of a randomized control trial.,"Lung resection surgery (LRS) causes an intense local and systemic inflammatory response. There is a relationship between inflammation and postoperative complications (POCs). Also, it has been proposed that the inflammation and complications related with the surgery may promote the recurrence of cancer and therefore deterioration of survival. We investigated the association between inflammatory biomarkers, severity of POCs and long-term outcome in patients who were discharged after LRS. This is a prospective substudy of a randomized control trial. We established three groups based in the presence of POCs evaluated by Clavien-Dindo (C-D) classification: Patients with no postoperative complications (No-POCs group) (C-D = 0), patients who developed light POCs (L-POCs group) (C-D = I-II), and major POCs (M-POCs group) (C-D = III, IV, or V). Kaplan-Meier curves and Cox regression model were created to compare survival and oncologic recurrence in those groups. Patients who developed POCs (light or major) had an increase in some inflammatory biomarkers (TNF-α, IL-6, IL-7, IL-8) compared with No-POCs group. This pro-inflammatory status plays a fundamental role in the appearance of POCs and therefore in a shorter life expectancy. Individuals in the M-POCs group had a higher risk of death (HR = 3.59, 95% CI 1.69 to 7.63) compared to individuals in the No-POCs group (p = 0.001). Patients of L-POCs group showed better survival than M-POCs group (HR = 2.16, 95% CI 1.00 to 4.65, p = 0.049). Besides, M-POCs patients had higher risk of recurrence in the first 2 years, when compared with L-POCs (p = 0,008) or with No-POCs (p = 0.002). In patients who are discharged after undergoing oncologic LRS, there is an association between POCs occurrence and long term outcome. Oncologist should pay special attention in patients who develop POCs after LRS.",2020,"Patients who developed POCs (light or major) had an increase in some inflammatory biomarkers (TNF-α, IL-6, IL-7, IL-8) compared with No-POCs group.","['patients who develop POCs after LRS', 'patients who were discharged after LRS', ' Patients with no postoperative complications (No-POCs group) (C-D\u2009=\u20090), patients who developed light POCs (L-POCs group) (C-D\u2009=\u2009I-II), and major POCs (M-POCs group']","['Lung resection surgery (LRS', 'oncologic lung resection surgery']","['risk of death', 'inflammation and postoperative complications (POCs', 'survival and oncologic recurrence', 'survival', 'risk of recurrence', 'inflammatory biomarkers (TNF-α, IL-6, IL-7, IL-8']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021761', 'cui_str': 'Interleukin-7'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}]",,0.0669892,"Patients who developed POCs (light or major) had an increase in some inflammatory biomarkers (TNF-α, IL-6, IL-7, IL-8) compared with No-POCs group.","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Casanova Barea', 'Affiliation': 'Gregorio Maranon Hospital, Madrid, Spain. javiercasanovabarea@yaho.es.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'De la Gala', 'Affiliation': 'Gregorio Maranon Hospital, Madrid, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Piñeiro', 'Affiliation': 'Gregorio Maranon Hospital, Madrid, Spain.'}, {'ForeName': 'Almudena', 'Initials': 'A', 'LastName': 'Reyes', 'Affiliation': 'Gregorio Maranon Hospital, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Simón', 'Affiliation': 'Gregorio Maranon Hospital, Madrid, Spain.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Rancan', 'Affiliation': 'Medicine Faculty in Complutense University, Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Vara', 'Affiliation': 'Medicine Faculty in Complutense University, Madrid, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Paredes', 'Affiliation': 'Medicine Faculty in Complutense University, Madrid, Spain.'}, {'ForeName': 'Jose María', 'Initials': 'JM', 'LastName': 'Bellón', 'Affiliation': 'Gregorio Maranon Hospital, Madrid, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Garutti Martinez', 'Affiliation': 'Gregorio Maranon Hospital, Madrid, Spain.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-020-00580-1']
2531,32797375,"Does probiotic supplementation aid weight loss? A randomized, single-blind, placebo-controlled study with Bifidobacterium lactis BS01 and Lactobacillus acidophilus LA02 supplementation.","PURPOSE


Probiotic supplements are gaining popularity worldwide. This trend is especially present in females, and a common motivation for consumption is weight loss, no matter the BMI. The aim of this study was to investigate the effects of probiotic supplementation on weight loss in healthy, young adult females and to put claims made by manufacturers of such products to the test.
METHODS


The study utilizes a randomized, single-blind, placebo-control design. 53 females aged 19-33 were enrolled, and 38 completed the trial. A 6 week supplementation with Bifidobacterium lactis BS01 and Lactobacillus acidophilus LA02 or placebo was conducted. Anthropometric measures (body mass, BMI, body fat percentage, arm skinfold fat, waist circumference, and WHR) were applied pre and post-treatment.
RESULTS


No significant changes in anthropometric measures were observed in both supplementation and placebo groups.
CONCLUSION


The results of this investigation do not support claims made by probiotic products manufacturers, that they aid weight loss. Our results seem to support an argument that weight loss is mostly associated with food habits and dietary behaviors, not probiotic intake. It is possible that probiotic supplementation may play a facilitating weight loss but has no effect without dietary intervention. Another possible explanation is that due to strain specificity-bacteria strains used in this study are not effective for weight loss.
LEVEL OF EVIDENCE


I: randomized controlled trial.",2020,"No significant changes in anthropometric measures were observed in both supplementation and placebo groups.
","['healthy, young adult females', '53 females aged 19-33 were enrolled, and 38 completed the trial']","['probiotic supplementation', 'Bifidobacterium lactis BS01 and Lactobacillus acidophilus LA02 supplementation', 'Bifidobacterium lactis BS01 and Lactobacillus acidophilus LA02 or placebo', 'placebo']","['weight loss', 'anthropometric measures', 'Anthropometric measures (body mass, BMI, body fat percentage, arm skinfold fat, waist circumference, and WHR']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1001866', 'cui_str': 'Bifidobacterium animalis'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}]",53.0,0.108238,"No significant changes in anthropometric measures were observed in both supplementation and placebo groups.
","[{'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Czajeczny', 'Affiliation': 'Chair and Department of Clinical Psychology, Poznan University of Medical Sciences, Poznan, Poland. d.czajeczny@gmail.com.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Kabzińska', 'Affiliation': 'Chair and Department of Clinical Psychology, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Rafał Wojciech', 'Initials': 'RW', 'LastName': 'Wójciak', 'Affiliation': 'Chair and Department of Clinical Psychology, Poznan University of Medical Sciences, Poznan, Poland.'}]",Eating and weight disorders : EWD,['10.1007/s40519-020-00983-8']
2532,32797376,Long-term outcomes of induction chemotherapy followed by chemoradiotherapy vs chemoradiotherapy alone as treatment of unresectable head and neck cancer: follow-up of the Spanish Head and Neck Cancer Group (TTCC) 2503 Trial.,"BACKGROUND


Our previous phase-3 study (TTCC 2503) failed to show overall survival advantage of 2 induction chemotherapy (IC) regimens followed by standard concurrent chemoradiotherapy (CRT) over CRT alone in patients with unresectable locally advanced head and neck squamous-cell carcinoma (LAHNSCC). This study described the long-term survival of those patients.
MATERIALS AND METHODS


Long-term follow-up study of patients with untreated LAHNSCC assigned to IC (three cycles), with either docetaxel, cisplatin and 5-fluorouracil (TPF arm) or cisplatin and 5-fluorouracil (PF arm), followed by CRT, or CRT alone, included in the previous TTCC 2503 trial.
RESULTS


In the intention-to-treat population (n = 439), the median OS times were 25.4 (95% CI, 16.8-34.4), 26.2 (95% CI, 18.2-36.6) and 25.4 months (95% CI, 17.4-36.0) in the TPF-CRT, PF-CRT and CRT arms, respectively (log-rank p = 0.51). In the per-protocol population (n = 355), patients with larynx-hypopharynx primary tumors treated with IC (TPF or PF) followed by CRT had a longer median PFS than those who received CRT alone. Moreover, patients with ECOG 0 treated with IC (TPF or PF) followed by CRT had a better TTF than those with CRT alone. There were no statistically significant differences in terms of OS, PFS or TTF, according to the tumor load or affected nodes.
CONCLUSION


After a long follow-up, the TTCC 2503 trial failed to show the benefit of IC-CRT in unresectable LAHNSCC regarding the primary end point. However, fit patients with ECOG 0 and primary larynx-hypopharyngeal tumors may benefit from the use of IC if administered by an experienced team. ClinicalTrials.gov identifier NCT00261703.",2020,"There were no statistically significant differences in terms of OS, PFS or TTF, according to the tumor load or affected nodes.
","['Long-term follow-up study of patients with untreated LAHNSCC assigned to IC (three cycles), with either', 'patients with unresectable locally advanced head and neck squamous-cell carcinoma (LAHNSCC', 'unresectable head and neck cancer', 'patients with larynx-hypopharynx primary tumors treated with']","['CRT', 'IC (TPF or PF', 'induction chemotherapy', 'Neck Cancer Group (TTCC', 'docetaxel, cisplatin and 5-fluorouracil (TPF arm) or cisplatin and 5-fluorouracil (PF arm), followed by CRT, or CRT alone', 'chemoradiotherapy vs chemoradiotherapy alone', 'induction chemotherapy (IC) regimens followed by standard concurrent chemoradiotherapy (CRT) over CRT alone']","['median OS times', 'overall survival advantage', 'OS, PFS or TTF, according to the tumor load or affected nodes', 'median PFS']","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0023051', 'cui_str': 'Disorder of the larynx'}, {'cui': 'C0020629', 'cui_str': 'Hypopharyngeal structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0746787', 'cui_str': 'Malignant tumor of neck'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C4087167', 'cui_str': 'Tumour treating fields therapy'}, {'cui': 'C1449699', 'cui_str': 'Tumor Load'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",,0.198812,"There were no statistically significant differences in terms of OS, PFS or TTF, according to the tumor load or affected nodes.
","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hitt', 'Affiliation': 'Medical Oncology Department, Hospital Universitario Severo Ochoa, Avda. de Orellana, s/n, 28911, Leganés (Madrid), Spain. rhitt@telefonica.net.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Iglesias', 'Affiliation': 'Medical Oncology Department, Hospital Universitario, 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'López-Pousa', 'Affiliation': 'Medical Oncology Department, Hospital de la Santa Creu i Sant Pau, Calalunya, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Berrocal-Jaime', 'Affiliation': 'Medical Oncology Department, Consorci Hospital General Universitari de Valencia, Valencia, Spain.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Grau', 'Affiliation': 'Medical Oncology Department, Hospital Clinic de Barcelona, Catalunya, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'García-Girón', 'Affiliation': 'Medical Oncology Department, Hospital Universitario de Burgos, Castilla y León, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Martínez-Trufero', 'Affiliation': 'Medical Oncology Department, Hospital Universitario Miguel Servet, Aragón, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Guix', 'Affiliation': 'Medical Oncology Department, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lambea-Sorrosal', 'Affiliation': 'Medical Oncology Department, Hospital Clínico Lozano Blesa, Zaragoza, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Del Barco-Morillo', 'Affiliation': 'Medical Oncology Department, Hospital Universitario de Salamanca, Castilla y León, Spain.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'León-Vintró', 'Affiliation': 'ENT Department, Hospital de la Santa Creu i Sant Pau, Catalunya, Spain.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Cunquero-Tomas', 'Affiliation': 'Medical Oncology Department, Consorci Hospital General Universitari de Valencia, Valencia, Spain.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Baste', 'Affiliation': 'Medical Oncology Department, Hospital Clinic de Barcelona, Catalunya, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ocaña', 'Affiliation': 'Medical Oncology Department, Hospital Universitario de Salamanca, Castilla y León, Spain.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Cruz-Hernández', 'Affiliation': 'Medical Oncology Department, Hospital Universitario de Salamanca, Castilla y León, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico,['10.1007/s12094-020-02467-8']
2533,32790783,Observed feeding behaviours and effects on child weight and length at 12 months of age: Findings from the SPRING cluster-randomized controlled trial in rural India.,"BACKGROUND


Child undernutrition results in poor growth in early childhood, undermines optimal development and increases the risk of mortality. Responsive feeding has been promoted as a key intervention for improving nutritional status, however measurement of this remains difficult and has rarely considered child behaviour. We therefore developed a new observed feeding tool to assess both child and caregiver behaviours, as well as their interaction during feeding, and investigate the effect of these on children anthropometric measures at 12-months of age in rural India.
METHODS


Our study was nested within the SPRING cluster-randomized controlled trial in Rewari, North India. Outcomes were children length-for-age (LAZ), weight-for-length (WLZ) and weight-for-age (WAZ) Z scores at 12 months of age, based on the WHO Child Growth standards. Trained non-specialists live-coded feeding episodes using the newly designed tool. Scores were then created using principal components analysis representing child behaviour, caregiver behaviour and caregiver-child interaction. Mixed effects linear regression was used to assess associations between feeding behaviours and anthropometric outcomes.
RESULTS


857 children had a meal observation and were included. Anthropometric status was poor (mean length-for-age -1.59 (SD = 1.11); mean weight-for-length -0.58 (0.95); mean weight-for-age -1.22 (1.04)). There were positive linear differences in weight-for-length per unit increase in caregiver responsive behaviours score (adjusted β-coeff = 0.006, 95%CI = (0.001, 0.011), p = 0.01), in length-for-age and weight-for-age per unit increase in child responsive behaviours score (respectively adjusted β-coeff = 0.004, 95%CI = (0.001, 0.007), p = 0.02, and adjusted β-coeff = 0.003, 95%CI = (0.00001, 0.006), p = 0.049), and in both weight-for-length and weight-for-age per unit increase in caregiver-child interaction score (respectively adjusted β-coeff = 0.007, 95%CI = (0.003, 0.012), p = 0.001, and adjusted β-coeff = 0.005, 95%CI = (0.001, 0.011), p = 0.01). No association was seen between child behaviours and weight-for-length, caregiver behaviours and length and caregiver-child interaction and length.
CONCLUSIONS


We found that trained non-specialists could assess feeding episodes using a newly designed checklist. Further, child and caregiver behaviours were associated with weight and length at only 12 months of age, a reminder of the importance of interventions to improve responsive feeding quality as we strive towards achievement of the sustainable development goals.",2020,"No association was seen between child behaviours and weight-for-length, caregiver behaviours and length and caregiver-child interaction and length.
",['857 children had a meal observation and were included'],[],"['children length-for-age (LAZ), weight-for-length (WLZ) and weight-for-age (WAZ) Z scores', 'mean weight', 'Anthropometric status', 'child behaviours and weight-for-length, caregiver behaviours and length and caregiver-child interaction and length', 'child responsive behaviours score', 'weight-for-length per unit increase in caregiver responsive behaviours score', 'child weight and length', 'weight-for-length and weight-for-age per unit increase in caregiver-child interaction score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1321223', 'cui_str': 'Caregiver behavior'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",857.0,0.11637,"No association was seen between child behaviours and weight-for-length, caregiver behaviours and length and caregiver-child interaction and length.
","[{'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Boucheron', 'Affiliation': 'Maternal & Child Health Intervention Research Group, Department of Population Health, Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Bhopal', 'Affiliation': 'Maternal & Child Health Intervention Research Group, Department of Population Health, Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Deepali', 'Initials': 'D', 'LastName': 'Verma', 'Affiliation': 'Child Development Group, Sangath, New Delhi, India.'}, {'ForeName': 'Reetabrata', 'Initials': 'R', 'LastName': 'Roy', 'Affiliation': 'Maternal & Child Health Intervention Research Group, Department of Population Health, Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Kumar', 'Affiliation': 'Child Development Group, Sangath, New Delhi, India.'}, {'ForeName': 'Gauri', 'Initials': 'G', 'LastName': 'Divan', 'Affiliation': 'Child Development Group, Sangath, New Delhi, India.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Kirkwood', 'Affiliation': 'Maternal & Child Health Intervention Research Group, Department of Population Health, Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0237226']
2534,32790788,"RE-PERG in early-onset Alzheimer's disease: A double-blind, electrophysiological pilot study.","PURPOSE


To evaluate the ability of re-test pattern electroretinogram (RE-PERG), a non-invasive and fast steady-state PERG, to detect inner retinal bioelectric function anomalies in patients with early-onset Alzheimer's disease (AD).
METHODS


The study population consisted of 17 patients with AD-related mild cognitive impairment (MCI), 16 patients with vascular dementia (VD)-related MCI, both assessed using the neuropsychological Mini-Mental State Examination (MMSE) and by structural magnetic resonance imaging, and 19 healthy, age-matched normal controls (NC). All participants were visually asymptomatic, had normal or near-normal general cognitive functioning and no or minimal impairments in daily life activities. Visual field (VF) test, optical coherence tomography (OCT) and RE-PERG, sampled in five consecutive blocks of 130 events, were performed.
RESULTS


There was no statistically significant difference among the three groups with respect to age, VF parameters (mean and pattern standard deviations) and OCT parameters (ganglion cell complex thickness and retinal nerve fiber layer thickness). The mean amplitude in the RE-PERG was significantly lower, but only weakly in the AD group than in NC (p = 0.1) whereas the intrinsic variability of the 2nd harmonic phase was significantly higher in the AD group than in either the VD or NC group (p<0.001).
CONCLUSIONS


RE-PERG is altered in early-stage AD, showing a reduced amplitude with high intrinsic phase variability. It also allows the discrimination of AD from VD. A high intrinsic variability in the PERG signal, determined using RE-PERG, may thus be a new promising test for neurodegenerative diseases.",2020,"The mean amplitude in the RE-PERG was significantly lower, but only weakly in the AD group than in NC (p = 0.1) whereas the intrinsic variability of the 2nd harmonic phase was significantly higher in the AD group than in either the VD or NC group (p<0.001).
","['All participants were visually asymptomatic, had normal or near-normal general cognitive functioning and no or minimal impairments in daily life activities', '17 patients with AD-related mild cognitive impairment (MCI), 16 patients with vascular dementia (VD)-related MCI, both assessed using the neuropsychological Mini-Mental State Examination (MMSE) and by structural magnetic resonance imaging, and 19 healthy, age-matched normal controls (NC', 'five consecutive blocks of 130 events, were performed', ""patients with early-onset Alzheimer's disease (AD"", ""early-onset Alzheimer's disease""]","['RE-PERG', 're-test pattern electroretinogram (RE-PERG']","['Visual field (VF) test, optical coherence tomography (OCT) and RE-PERG', 'OCT parameters (ganglion cell complex thickness and retinal nerve fiber layer thickness', 'mean amplitude in the RE-PERG', 'intrinsic variability of the 2nd harmonic phase']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0011269', 'cui_str': 'Vascular dementia'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0750901', 'cui_str': 'Primary degenerative dementia of the Alzheimer type, presenile onset'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0013867', 'cui_str': 'Electroretinography'}]","[{'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0035316', 'cui_str': 'Retinal Ganglion Cells'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",17.0,0.0540823,"The mean amplitude in the RE-PERG was significantly lower, but only weakly in the AD group than in NC (p = 0.1) whereas the intrinsic variability of the 2nd harmonic phase was significantly higher in the AD group than in either the VD or NC group (p<0.001).
","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Mavilio', 'Affiliation': 'Social Health District, Glaucoma Center, Azienda Sanitaria Locale-Brindisi, Brindisi, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Sisto', 'Affiliation': 'Department of Neurosciences, Institute of Ophthalmology, University of Bari, Bari, Italy.'}, {'ForeName': 'Florenza', 'Initials': 'F', 'LastName': 'Prete', 'Affiliation': 'Social Health District, Alzheimer Evaluation Units, Azienda Sanitaria Locale-Brindisi, Brindisi, Italy.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Guadalupi', 'Affiliation': 'Social Health District, Alzheimer Evaluation Units, Azienda Sanitaria Locale-Brindisi, Brindisi, Italy.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Dammacco', 'Affiliation': 'Department of Neurosciences, Institute of Ophthalmology, University of Bari, Bari, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Alessio', 'Affiliation': 'Department of Neurosciences, Institute of Ophthalmology, University of Bari, Bari, Italy.'}]",PloS one,['10.1371/journal.pone.0236568']
2535,32790789,Identification and treatment of obstructive sleep apnea by a primary care team with a subset focus on chronic pain management.,"BACKGROUND


Patients diagnosed with obstructive sleep apnea (OSA), who also consume prescription opioids, have a greater likelihood of morbidity and mortality. This study evaluated whether a primary care team, focused on chronic pain care management, could use a validated questionnaire (STOP-Bang) and motivational follow-up, to increase identification and treatment of OSA.
METHODS


This study was a retrospective, dual arm, pre/post controlled study. Participants of this study included the complete chronic pain management sub group treated by this primary care team. Participants were ≥ 18 years old and prescribed daily opioids for treatment of chronic pain. All participants had a multifaceted, individualized, educational meeting that included completing a STOP-Bang questionnaire. Participants who received a score ≥ three were advised to follow up with their primary care physician. Participants were seen quarterly throughout the study.
RESULTS


The primary outcome of this study was that 65% of participants with likely OSA were using CPAP for a minimum of 12 months (range of 12-25 months, 18-month average) post-intervention vs. 37% CPAP-use in the control group (12 months of observation), both groups were chronic opioid users with OSA. This was a 28% relative improvement (p = 0.0034). A secondary outcome was that 8.9% of non-prior CPAP users obtained CPAP post- intervention; a 56.7% pre-post improvement (p = 0.0064, x2 = 10.08 with 1 degree of freedom). Also, participants who were likely to have OSA (STOP-Bang score ≥ 3 or had a positive polysomnography (AHI >5 with comorbidities)) compared to those unlikely to have OSA (STOP-Bang score <3 or had a negative polysomnography (AHI <5)) in this study were more likely to be male, have a higher BMI, have hypertension, have cardiovascular disease and/or have diabetes (all types).
CONCLUSION


Team based care management for participants taking prescription opioids, where STOP-Bang questionnaires were completed, were associated with an increase in the identification and treatment of OSA.",2020,This was a 28% relative improvement (p = 0.0034).,"['All participants had a multifaceted, individualized, educational meeting that included completing a STOP-Bang questionnaire', 'Patients diagnosed with obstructive sleep apnea (OSA', 'Participants were ≥ 18 years old and prescribed daily opioids for treatment of chronic pain', 'participants who were likely to have OSA (STOP-Bang score ≥ 3 or had a positive polysomnography', 'Participants who received a score ≥ three were advised to follow up with their primary care physician']","['CPAP', 'negative polysomnography']","['obstructive sleep apnea', 'likely OSA']","[{'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0302363', 'cui_str': 'Infection due to Brucella abortus'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C1828381', 'cui_str': 'Recommendation - action'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}]","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}]",,0.0590701,This was a 28% relative improvement (p = 0.0034).,"[{'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Whittington', 'Affiliation': 'Internal Medicine, Intermountain Healthcare, Sandy, Utah, United States of America.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Simpson', 'Affiliation': 'Intermountain Healthcare, Sandy, Utah, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Clay', 'Affiliation': 'Pulmonary and Sleep Medicine, Intermountain Healthcare, Sandy, Utah, United States of America.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Tierney', 'Affiliation': 'Intermountain Healthcare, Sandy, Utah, United States of America.'}, {'ForeName': 'Dixie', 'Initials': 'D', 'LastName': 'Harris', 'Affiliation': 'Pulmonary and Sleep Medicine, Intermountain Healthcare, Sandy, Utah, United States of America.'}]",PloS one,['10.1371/journal.pone.0237359']
2536,32790792,Caffeine increases motor output entropy and performance in 4 km cycling time trial.,"Caffeine improves cycling time trial performance through enhanced motor output and muscle recruitment. However, it is unknown if caffeine further increases power output entropy. To investigate the effects of caffeine effects on cycling time trial performance and motor output entropy (MOEn), nine cyclists (VO2MAX of 55 ± 6.1 mL.kg.-1min-1) performed a 4 km cycling time trial (TT4km) after caffeine and placebo ingestion in a counterbalanced order. Power output data were sampled at a 2 Hz frequency, thereafter entropy was estimated on a sliding-window fashion to generate a power output time series. A number of mixed models compared performance and motor output entropy between caffeine and placebo every 25% of the total TT4km distance. Caffeine ingestion improved power output by 8% (p = 0.003) and increased MOEn by 7% (p = 0.018). Cyclists adopted a U-shaped pacing strategy after caffeine ingestion. MOEn mirrored power output responses as an inverted U-shape MOEn during the time trial. Accordingly, a strong inverse correlation was observed between MOEn and power output responses over the last 25% of the TT4km (p < 0.001), regardless of the ingestion, likely reflecting the end spurt during this period (p = 0.016). Caffeine ingestion improved TT4km performance and motor output responses likely due to a greater power output entropy.",2020,Caffeine ingestion improved power output by 8% (p = 0.003) and increased MOEn by 7% (p = 0.018).,['nine cyclists (VO2MAX of 55 ± 6.1 mL.kg.-1min-1'],"['caffeine and placebo', 'caffeine', 'Caffeine', 'caffeine and placebo ingestion', 'Caffeine ingestion']","['TT4km performance and motor output responses', 'cycling time trial performance and motor output entropy (MOEn', 'MOEn', 'MOEn and power output responses', 'power output']",[],"[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0445194', 'cui_str': 'Power output'}]",,0.256056,Caffeine ingestion improved power output by 8% (p = 0.003) and increased MOEn by 7% (p = 0.018).,"[{'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Ferreira Viana', 'Affiliation': 'Physical Education course, Augusto Motta University Center (UNISUAM), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Gabriel S', 'Initials': 'GS', 'LastName': 'Trajano', 'Affiliation': 'School of Exercise and Nutrition Sciences, Queensland University of Technology, Kelvin Grove, QLD, Australia.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ugrinowitsch', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, SP, Brazil.'}, {'ForeName': 'Flávio', 'Initials': 'F', 'LastName': 'Oliveira Pires', 'Affiliation': 'Exercise Psychophysiology Research Group, School of Arts, Sciences and Humanities, University of São Paulo, SP, Brazil.'}]",PloS one,['10.1371/journal.pone.0236592']
2537,32791048,"Sorafenib maintenance in patients with FLT3-ITD acute myeloid leukaemia undergoing allogeneic haematopoietic stem-cell transplantation: an open-label, multicentre, randomised phase 3 trial.","BACKGROUND


Findings of retrospective studies suggest that sorafenib maintenance post-transplantation might reduce relapse in patients with FLT3 internal tandem duplication (FLT3-ITD) acute myeloid leukaemia undergoing allogeneic haematopoietic stem-cell transplantation. We investigated the efficacy and tolerability of sorafenib maintenance post-transplantation in this population.
METHODS


We did an open-label, randomised phase 3 trial at seven hospitals in China. Eligible patients (aged 18-60 years) had FLT3-ITD acute myeloid leukaemia, were undergoing allogeneic haematopoietic stem-cell transplantation, had an Eastern Cooperative Oncology Group performance status of 0-2, had composite complete remission before and after transplantation, and had haematopoietic recovery within 60 days post-transplantation. Patients were randomly assigned (1:1) to sorafenib maintenance (400 mg orally twice daily) or non-maintenance (control) at 30-60 days post-transplantation. Randomisation was done with permuted blocks (block size four) and implemented through an interactive web-based randomisation system. The primary endpoint was the 1-year cumulative incidence of relapse in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02474290; the trial is complete.
FINDINGS


Between June 20, 2015, and July 21, 2018, 202 patients were enrolled and randomly assigned to sorafenib maintenance (n=100) or control (n=102). Median follow-up post-transplantation was 21·3 months (IQR 15·0-37·0). The 1-year cumulative incidence of relapse was 7·0% (95% CI 3·1-13·1) in the sorafenib group and 24·5% (16·6-33·2) in the control group (hazard ratio 0·25, 95% CI 0·11-0·57; p=0·0010). Within 210 days post-transplantation, the most common grade 3 and 4 adverse events were infections (25 [25%] of 100 patients in the sorafenib group vs 24 [24%] of 102 in the control group), acute graft-versus-host-disease (GVHD; 23 [23%] of 100 vs 21 [21%] of 102), chronic GVHD (18 [18%] of 99 vs 17 [17%] of 99), and haematological toxicity (15 [15%] of 100 vs seven [7%] of 102). There were no treatment-related deaths.
INTERPRETATION


Sorafenib maintenance post-transplantation can reduce relapse and is well tolerated in patients with FLT3-ITD acute myeloid leukaemia undergoing allogeneic haematopoietic stem-cell transplantation. This strategy could be a suitable therapeutic option for patients with FLT3-ITD acute myeloid leukaemia.
FUNDING


None.",2020,Median follow-up post-transplantation was 21·3 months (IQR 15·0-37·0).,"['Between June 20, 2015, and July 21, 2018, 202 patients were enrolled and randomly assigned to', 'patients with FLT3-ITD acute myeloid leukaemia', 'patients with FLT3-ITD acute myeloid leukaemia undergoing allogeneic haematopoietic stem-cell transplantation', 'Eligible patients (aged 18-60 years) had FLT3-ITD acute myeloid leukaemia, were undergoing allogeneic haematopoietic stem-cell transplantation, had an Eastern Cooperative Oncology Group performance status of 0-2, had composite complete remission before and after transplantation, and had haematopoietic recovery within 60 days post-transplantation', 'seven hospitals in China', 'n=100) or control (n=102', 'patients with FLT3 internal tandem duplication (FLT3-ITD) acute myeloid leukaemia undergoing allogeneic haematopoietic stem-cell transplantation']","['sorafenib', 'sorafenib maintenance (400 mg orally twice daily) or non-maintenance (control', 'Sorafenib maintenance', 'sorafenib maintenance post-transplantation', 'sorafenib maintenance']","['chronic GVHD', '1-year cumulative incidence of relapse', 'efficacy and tolerability', 'haematological toxicity', 'acute graft-versus-host-disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0251006', 'cui_str': 'FLT3 protein, human'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0332597', 'cui_str': 'Duplication'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0018957', 'cui_str': 'Hematopoietic system structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease'}]",202.0,0.369632,Median follow-up post-transplantation was 21·3 months (IQR 15·0-37·0).,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xuan', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Hematology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yajing', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Hematology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Deng', 'Affiliation': 'Department of Hematology, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Hematology, Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Xinquan', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': ""Department of Hematology, First People's Hospital of Chenzhou, Chenzhou, China.""}, {'ForeName': 'Xiaodan', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Department of Hematology, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Pengcheng', 'Initials': 'P', 'LastName': 'Shi', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Zhixiang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Chunzi', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': ""Department of Hematology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Lin', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Sanfang', 'Initials': 'S', 'LastName': 'Tu', 'Affiliation': 'Department of Hematology, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ""Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China; Department of Hematology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Qifa', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China. Electronic address: liuqifa628@163.com.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30455-1']
2538,32791086,Proteinuria Reduction and Kidney Survival in Focal Segmental Glomerulosclerosis.,"RATIONALE & OBJECTIVE


Remission of proteinuria has been shown to be associated with lower rates of kidney disease progression among people with focal segmental glomerulosclerosis (FSGS). The goal of this study was to evaluate if reductions in proteinuria following treatment are associated with greater kidney survival.
STUDY DESIGN


Cohort analysis of clinical trial participants SETTING & PARTICIPANTS: Patients with steroid resistant FSGS enrolled in a randomized treatment trial that compared cyclosporine to mycophenolate mofetil plus dexamethasone.
PREDICTORS


Reduction in proteinuria measured during 26 weeks after initiating treatment OUTCOMES: Repeated measures of estimated glomerular filtration rate (eGFR) and, time to end-stage kidney disease (ESKD) or death assessed between 26 weeks and 54 months after randomization ANALYTIC APPROACH: Multivariable, linear-mixed effects models with subject-specific slope and intercept to estimate the association of change in proteinuria over 26 weeks while receiving treatment with the subsequent slope of change in eGFR. Multivariable, time-varying Cox-proportional hazards models were used to estimate the association of changes in proteinuria with time to ESKD or death.
RESULTS


138 of 192 trial participants were included. Changes in proteinuria over 26 weeks were significantly related to eGFR slope. A 1 unit reduction in log-transformed urinary protein:creatinine ratio was associated with a 3.90 ml/year rise in eGFR (95% CI=2.01 to 5.79). This difference remained significant after adjusting for complete remission. There was an analogous relationship between time-varying proteinuria and time to end-stage kidney disease: the HR for ESKD or death per 1 unit reduction in log-transformed urinary protein-creatinine ratio was 0.23 (95% CI=0.12 to 0.44).
LIMITATIONS


Limited to individuals with steroid-resistant FSGS followed for a maximum of five-years.
CONCLUSIONS


These findings provide evidence for the benefit of urinary protein reduction in FSGS. Reductions in proteinuria warrant further evaluation as a potential surrogate for preservation of kidney function that may inform the design of future clinical trials.",2020,"There was an analogous relationship between time-varying proteinuria and time to end-stage kidney disease: the HR for ESKD or death per 1 unit reduction in log-transformed urinary protein-creatinine ratio was 0.23 (95% CI=0.12 to 0.44).
","['people with focal segmental glomerulosclerosis (FSGS', 'individuals with steroid-resistant FSGS followed for a maximum of five-years', '138 of 192 trial participants were included', 'Patients with steroid resistant FSGS enrolled']",['cyclosporine to mycophenolate mofetil plus dexamethasone'],"['glomerular filtration rate (eGFR) and, time to end-stage kidney disease (ESKD) or death', 'log-transformed urinary protein:creatinine ratio', 'Proteinuria Reduction and Kidney Survival', 'Changes in proteinuria']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017668', 'cui_str': 'Focal glomerular sclerosis'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.167968,"There was an analogous relationship between time-varying proteinuria and time to end-stage kidney disease: the HR for ESKD or death per 1 unit reduction in log-transformed urinary protein-creatinine ratio was 0.23 (95% CI=0.12 to 0.44).
","[{'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Troost', 'Affiliation': 'Michigan Institute for Clinical and Health Research, University of Michigan, Ann Arbor, MI, USA. Electronic address: troostj@med.umich.edu.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Trachtman', 'Affiliation': 'Division of Nephrology, Department of Pediatrics, New York University Langone Health, New York, NY, USA.'}, {'ForeName': 'Cathie', 'Initials': 'C', 'LastName': 'Spino', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Frederick J', 'Initials': 'FJ', 'LastName': 'Kaskel', 'Affiliation': ""Division of Pediatric Nephrology, Children's Hospital at Montefiore, Bronx, New York, USA.""}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Friedman', 'Affiliation': 'Division of Nephrology, Department of Pediatrics, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Marva M', 'Initials': 'MM', 'LastName': 'Moxey-Mims', 'Affiliation': ""Division of Nephrology, Children's National Hospital, Department of Pediatrics, The George Washington University School of Medicine, Washington DC, USA.""}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Fine', 'Affiliation': 'Stony Brook University Medical Center, School of Medicine, Stony Brook, New York, USA.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Gassman', 'Affiliation': 'Department of Quantitative Health Sciences at the Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Kopp', 'Affiliation': 'Kidney Disease Section, National Institute of Diabetes and Digestive and Kidney Diseases, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Liron', 'Initials': 'L', 'LastName': 'Walsh', 'Affiliation': 'Goldfinch Bio, Cambridge, MA, USA.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Pfizer Inc., New York, NY, USA.'}, {'ForeName': 'Debbie S', 'Initials': 'DS', 'LastName': 'Gipson', 'Affiliation': 'Division of Nephrology, Department of Pediatrics, University of Michigan, Ann Arbor, MI, USA.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2020.04.014']
2539,32791295,Assessment of safety and efficacy of antimicrobial photodynamic therapy for peri-implant disease.,"BACKGROUND


There is no reliable treatment procedure for peri-implant disease, despite the rise in its incidence. This study sought to evaluate the short-term safety and efficacy of antimicrobial photodynamic therapy (a-PDT) on peri-implantitis by assessing the volume of pus discharge after a-PDT.
METHODS


Patients with pus discharge from a peri-implant pocket were recruited from December 1 st , 2019 to April 30 th , 2020. The enrolled implants were randomly assigned to one of two groups, the irrigation and a-PDT groups. Their peri-implant pocket was irrigated with normal saline in the irrigation group, and a saline irrigation and subsequent a-PDT with toluidine blue (TB) was performed in the a-PDT group. The safety and efficacy of a-PDT were assessed 7 days after treatment.
RESULTS


Twenty-five implants in 21 patients (irrigation group; 13 implants, a-PDT group; 12 implants) were registered. No complication was observed after a-PDT. Pus discharge was decreased in 7 of 12 implants (58.3%) in the a-PDT group, and in 2 of 13 implants (15.4%) in the irrigation group. According to Fisher's exact test, a-PDT resulted in a statistically significant decrease in pus discharge compared to irrigation alone (p = 0.0414).
CONCLUSIONS


a-PDT was confirmed to be a safe treatment for peri-implantitis, and the short-term efficacy of a-PDT with TB on peri-implantitis was clarified. Nevertheless, its efficacy remains restricted, and a new combination therapy of a-PDT and decontamination procedures is expected to be developed in future.",2020,"According to Fisher's exact test, a-PDT resulted in a statistically significant decrease in pus discharge compared to irrigation alone (p = 0.0414).
","['peri-implant disease', 'Patients with pus discharge from a peri-implant pocket were recruited from December 1 st , 2019 to April 30 th , 2020']","['antimicrobial photodynamic therapy', 'antimicrobial photodynamic therapy (a-PDT', 'saline irrigation and subsequent a-PDT with toluidine blue (TB']","['No complication', 'safety and efficacy', 'pus discharge', 'Pus discharge']","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034161', 'cui_str': 'Pus'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0040380', 'cui_str': 'Tolonium chloride'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0034161', 'cui_str': 'Pus'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",,0.0496946,"According to Fisher's exact test, a-PDT resulted in a statistically significant decrease in pus discharge compared to irrigation alone (p = 0.0414).
","[{'ForeName': 'Seigo', 'Initials': 'S', 'LastName': 'Ohba', 'Affiliation': 'Department of Regenerative Oral Surgery, Nagasaki University Graduate School of Biomedical Sciences, Japan; Center for Oral and Maxillofacial Implants, Nagasaki University Hospital, Japan. Electronic address: sohba@nagasaki-u.ac.jp.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Sato', 'Affiliation': 'Department of Dental Hygiene, Nagasaki University Hospital, Japan.'}, {'ForeName': 'Sawako', 'Initials': 'S', 'LastName': 'Noda', 'Affiliation': 'Department of Regenerative Oral Surgery, Nagasaki University Graduate School of Biomedical Sciences, Japan; Center for Oral and Maxillofacial Implants, Nagasaki University Hospital, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Regenerative Oral Surgery, Nagasaki University Graduate School of Biomedical Sciences, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Egahira', 'Affiliation': 'Department of Regenerative Oral Surgery, Nagasaki University Graduate School of Biomedical Sciences, Japan.'}, {'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Asahina', 'Affiliation': 'Department of Regenerative Oral Surgery, Nagasaki University Graduate School of Biomedical Sciences, Japan; Center for Oral and Maxillofacial Implants, Nagasaki University Hospital, Japan.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101936']
2540,32791318,Improving child behaviors and parental stress: A randomized trial of Child Adult Relationship Enhancement in Primary Care.,"BACKGROUND


Prior single site evaluations of PriCARE, a 6-session group parent training, demonstrated reductions in child behavioral problems and improvements in positive parenting attitudes.
OBJECTIVE


To measure the impact of PriCARE on disruptive child behaviors, parenting stress, and parenting attitudes in a multisite study.
METHODS


Caregivers of children 2- to 6-years-old with behavior concerns recruited from 4 pediatric primary care practices were randomized 2:1 to PriCARE intervention (n=119) or waitlist control (n=55). 79% of caregivers identified as Black and 59% had annual household incomes under $22,000. Child behavior, parenting stress, and parenting attitudes were measured at baseline and 2-3 months after intervention using the Eyberg Child Behavior Inventory (ECBI), Parenting Stress Index (PSI), and Adult-Adolescent Parenting Inventory-2 (AAPI-2). Marginal standardization implemented in a linear regression compared mean change scores from baseline to follow-up by treatment arm while accounting for clustering by site.
RESULTS


Mean change scores from baseline to follow-up demonstrated greater improvements (decreases) in ECBI problem scores but not intensity scores in the PriCARE arm compared to control, [problem: -4.4 (-7.5, -1.2) versus -1.8 (-4.1, 0.4), p=0.004; intensity: -17.6 (-28.3, -6.9) versus -10.4 (-18.1, -2.6), p=0.255]. Decreases in parenting stress were greater in the PriCARE arm compared to control [-3.3 (-4.3, -2.3,) versus 0 (-2.5, 2.5), p=0.025]. Parenting attitudes showed no significant changes (all p>0.10).
CONCLUSIONS


PriCARE showed promise in improving parental perceptions of the severity of child behaviors and decreasing parenting stress but did not have an observed impact on parenting attitudes.",2020,"Mean change scores from baseline to follow-up demonstrated greater improvements (decreases) in ECBI problem scores but not intensity scores in the PriCARE arm compared to control, [problem: -4.4 (-7.5, -1.2) versus -1.8","['Caregivers of children 2- to 6-years-old with behavior concerns recruited from 4 pediatric primary care practices', '79% of caregivers identified as Black and 59% had annual household incomes under $22,000']","['PriCARE', 'waitlist control', 'PriCARE intervention']","['disruptive child behaviors, parenting stress, and parenting attitudes', 'child behaviors and parental stress', 'Eyberg Child Behavior Inventory (ECBI), Parenting Stress Index (PSI), and Adult-Adolescent Parenting Inventory-2 (AAPI-2', 'Child behavior, parenting stress, and parenting attitudes', 'parenting stress', 'ECBI problem scores', 'Mean change scores']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0557163', 'cui_str': 'Household income'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1999012', 'cui_str': 'Parental role conflict'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0435019,"Mean change scores from baseline to follow-up demonstrated greater improvements (decreases) in ECBI problem scores but not intensity scores in the PriCARE arm compared to control, [problem: -4.4 (-7.5, -1.2) versus -1.8","[{'ForeName': 'Joanne N', 'Initials': 'JN', 'LastName': 'Wood', 'Affiliation': ""Division of General Pediatrics, The Children's Hospital of Philadelphia, 3401 Civic Center Blvd, Philadelphia, PA, 19104, USA; PolicyLab, The Children's Hospital of Philadelphia, 2716 South Street, Philadelphia PA, 19146, USA; Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, 3400 Civic Center Blvd, Philadelphia PA, 19104 USA. Electronic address: woodjo@email.chop.edu.""}, {'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Kratchman', 'Affiliation': ""PolicyLab, The Children's Hospital of Philadelphia, 2716 South Street, Philadelphia PA, 19146, USA. Electronic address: kratchmand@email.chop.edu.""}, {'ForeName': 'Philip V', 'Initials': 'PV', 'LastName': 'Scribano', 'Affiliation': ""Division of General Pediatrics, The Children's Hospital of Philadelphia, 3401 Civic Center Blvd, Philadelphia, PA, 19104, USA; Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, 3400 Civic Center Blvd, Philadelphia PA, 19104 USA. Electronic address: scribanop@email.chop.edu.""}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Berkowitz', 'Affiliation': 'Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, 3400 Civic Center Blvd, Philadelphia PA, 19104 USA. Electronic address: steven.berkowitz@cuanschutz.edu.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Schilling', 'Affiliation': 'Department of Pediatrics, University of North Carolina, 101 Manning Drive, Chapel Hill, NC, 27514 USA. Electronic address: samantha_schilling@med.unc.edu.'}]",Academic pediatrics,['10.1016/j.acap.2020.08.002']
2541,32791501,Sequential Combination of Cognitive-Behavioral Treatment and Well-Being Therapy in Depressed Patients with Acute Coronary Syndromes: A Randomized Controlled Trial (TREATED-ACS Study).,"INTRODUCTION


Randomized controlled trials (RCT) of psychotherapeutic interventions have addressed depression and demoralization associated with acute coronary syndromes (ACS). The present trial introduces psychological well-being, an increasingly recognized factor in cardiovascular health, as a therapeutic target.
OBJECTIVE


This study was designed to determine whether the sequential combination of cognitive-behavioral therapy (CBT) and well-being therapy (WBT) may yield more favorable outcomes than an active control group (clinical management; CM) and to identify subgroups of patients at greater risk for cardiac negative outcomes.
METHODS


This multicenter RCT comparedCBT/WBT sequential combination versus CM, with up to 30 months of follow-up. One hundred consecutive depressed and/or demoralized patients (out of 740 initially screened by cardiologists after a first episode of ACS) were randomized to CBT/WBT associated with lifestyle suggestions (n = 50) and CM (n = 50). The main outcome measures included: severity of depressive symptoms according to the Clinical Interview for Depression, changes in subclinical psychological distress, well-being, and biomarkers, and medical complications and events.
RESULTS


CBT/WBT sequential combination was associated with a significant improvement in depressive symptoms compared to CM. In both groups, the benefits persisted at follow-up, even though the differences faded. Treatment was also related to a significant amelioration of biomarkers (platelet count, HDL, and D-dimer), whereas the 2 groups showed similar frequencies of adverse cardiac events.
CONCLUSIONS


Addressing psychological well-being in the psychotherapeutic approach to ACS patients with depressive symptoms was found to entail important clinical benefits. It is argued that lifestyle changes geared toward cardiovascular health may be facilitated by a personalized approach that targets well-being.",2020,"Treatment was also related to a significant amelioration of biomarkers (platelet count, HDL, and D-dimer), whereas the 2 groups showed similar frequencies of adverse cardiac events.
","['Depressed Patients with Acute Coronary Syndromes', 'One hundred consecutive depressed and/or demoralized patients (out of 740 initially screened by cardiologists after a first episode of ACS', 'ACS patients with depressive symptoms']","['cognitive-behavioral therapy (CBT) and well-being therapy (WBT', 'CBT/WBT', 'psychotherapeutic interventions', 'Sequential Combination of Cognitive-Behavioral Treatment and Well-Being Therapy']","['amelioration of biomarkers (platelet count, HDL, and D-dimer', 'severity of depressive symptoms according to the Clinical Interview for Depression, changes in subclinical psychological distress, well-being, and biomarkers, and medical complications and events', 'depressive symptoms']","[{'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0175906', 'cui_str': 'Cardiologist'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0199182', 'cui_str': 'History taking'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",100.0,0.0324152,"Treatment was also related to a significant amelioration of biomarkers (platelet count, HDL, and D-dimer), whereas the 2 groups showed similar frequencies of adverse cardiac events.
","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Rafanelli', 'Affiliation': 'Department of Psychology, University of Bologna, Bologna, Italy, chiara.rafanelli@unibo.it.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Gostoli', 'Affiliation': 'Department of Psychology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Buzzichelli', 'Affiliation': 'Eating Disorders Center for Treatment and Research, Department of Neuroscience, University of Turin, Turin, Italy.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Guidi', 'Affiliation': 'Department of Psychology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Sirri', 'Affiliation': 'Department of Psychology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Gallo', 'Affiliation': 'Division of Cardiology, Maggiore Hospital, Bologna, Italy.'}, {'ForeName': 'Enrica', 'Initials': 'E', 'LastName': 'Marzola', 'Affiliation': 'Eating Disorders Center for Treatment and Research, Department of Neuroscience, University of Turin, Turin, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Bergerone', 'Affiliation': 'Division of Cardiology, Internal Medicine Department, Città della Salute e della Scienza, University of Turin, Turin, Italy.'}, {'ForeName': 'Gaetano Maria', 'Initials': 'GM', 'LastName': 'De Ferrari', 'Affiliation': 'Division of Cardiology, Internal Medicine Department, Città della Salute e della Scienza, University of Turin, Turin, Italy.'}, {'ForeName': 'Renzo', 'Initials': 'R', 'LastName': 'Roncuzzi', 'Affiliation': 'Division of Cardiology, Bellaria Hospital, Bologna, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Di Pasquale', 'Affiliation': 'Division of Cardiology, Maggiore Hospital, Bologna, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Abbate-Daga', 'Affiliation': 'Eating Disorders Center for Treatment and Research, Department of Neuroscience, University of Turin, Turin, Italy.'}, {'ForeName': 'Giovanni A', 'Initials': 'GA', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, University at Buffalo, Buffalo, New York, USA.'}]",Psychotherapy and psychosomatics,['10.1159/000510006']
2542,32791583,"[Myringotomy or tympanostomy tube insertion, comparison of surgical treatment of adenoid hypertrophy and otitis media with effusion in children].","Objective: The study aimed to observe the difference in postoperative complications and recurrence rates of adenoidectomy plus myringotomy or adenoidectomy plus tympanostomy with tube insertion for children with adenoid hypertrophy combined with otitis media with effusion.  Method: Children 4 to 12 years old with otitis media with effusion combined with adenoid hypertrophy were assigned to receive either adenoidectomy plus myringotomy（group A） or adenoidectomy plus tympanostomy tube insertion（group B）. Pre-and post-operative data was recorded.  Result: There is no ear complication in group A. In group B, some children suffered otorrhea, perforation, blocked tympanic membrane vent and calcification. The recurrence rate of the group A was significantly higher than that of the group B at 3 month after operation. There was no significant difference in recurrence rate between the two groups at 6th month and 12th month after operation.  Conclusion: For children aged 4-12 years with adenoid hypertrophy combined with otitis media with effusion, adenoidectomy plus myringotomy can avoid complications after tympanic tube insertion without increasing the risk of long-term recurrence, we recommend this procedure as the first choice.",2020,There is no ear complication in,"['children with adenoid hypertrophy combined with otitis media with effusion', 'Method: Children 4 to 12 years old with otitis media with effusion combined with adenoid hypertrophy', 'children aged 4-12 years with adenoid hypertrophy combined with otitis media with effusion', 'adenoid hypertrophy and otitis media with effusion in children']","['adenoidectomy plus tympanostomy', 'adenoidectomy plus myringotomy（group', 'adenoidectomy plus myringotomy', 'Myringotomy or tympanostomy tube insertion', 'adenoidectomy plus myringotomy or adenoidectomy plus tympanostomy with tube insertion']","['children suffered otorrhea, perforation, blocked tympanic membrane vent and calcification', 'postoperative complications and recurrence rates', 'recurrence rate']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0149825', 'cui_str': 'Hypertrophy of adenoids'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0029883', 'cui_str': 'Middle ear effusion'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0001425', 'cui_str': 'Adenoid excision'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0087123', 'cui_str': 'Tympanostomy'}, {'cui': 'C0041450', 'cui_str': 'Tympanostomy Tube Insertion'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0155540', 'cui_str': 'Ear discharge'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0041445', 'cui_str': 'Tympanic membrane structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.0506732,There is no ear complication in,"[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Tao', 'Affiliation': ""Department of Otolaryngology，Guangzhou Women and Children's Medical Center，Guangzhou，510623，China.""}, {'ForeName': 'Renzhong', 'Initials': 'R', 'LastName': 'Luo', 'Affiliation': ""Department of Otolaryngology，Guangzhou Women and Children's Medical Center，Guangzhou，510623，China.""}, {'ForeName': 'Yanqiu', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of Otolaryngology，Guangzhou Women and Children's Medical Center，Guangzhou，510623，China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Hou', 'Affiliation': ""Department of Otolaryngology，Guangzhou Women and Children's Medical Center，Guangzhou，510623，China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Qin', 'Affiliation': ""Department of Otolaryngology，Guangzhou Women and Children's Medical Center，Guangzhou，510623，China.""}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.03.005']
2543,32791589,[Effect of sublingual immunotherapy on inflammatory factors and autophagy in patients with allergic rhinitis].,"Objective: To observe the effect of sublingual immunotherapy on the expression of serum inflammatory factors IL-4 and TNF-α as well as autophagy-associated protein LC3 in nasal mucosa in patients with allergic rhinitis（AR）.  Method: Forty patients with AR were randomly divided into SLIT group（ n =20） and control group（ n =20）, the SLIT group received a 2-year intervention with a standardized dust mite vaccine SLIT in combination with conventional drugs, the control group received placebo and conventional drug treatment. Blood samples and inferior turbinate mucosa were collected of both groups before and after the treatment; the clinical symptoms, signs and medication scores of the two groups before and after treatment were analyzed; the expressions of serum IL-4 and TNF-α were detected by ELISA before and after treatment; the expression of autophagy-related protein LC3 was detected by Western blot.  Result: There were no significant differences in the pre-treatment signs, symptoms, medication scores, age, gender, serum IL-4, TNF-α, and LC3 expression between the SLIT group and the control group（ P >0.05）. After a 2-year treatment, the symptom scores the of SLIT group were significantly improved compared with the control group; serum levels of IL-4 and TNF-α were significantly decreased in the SLIT group; the expression of autophagy-related protein LC3 in the SLIT group was significantly lower than that in the control group, and the difference was statistically significant（ P <0.05）.  Conclusion: SLIT combined with conventional drug therapy is more effective in improving the symptoms of AR patients than conventional drug therapy. SLIT can reduce the inflammation level and expression of autophagy-related proteins in AR patients to a certain extent.",2020,"There were no significant differences in the pre-treatment signs, symptoms, medication scores, age, gender, serum IL-4, TNF-α, and LC3 expression between the SLIT group and the control group（ P >0.05）.","['Forty patients with AR', 'patients with allergic rhinitis（AR）', 'patients with allergic rhinitis']","['sublingual immunotherapy', 'LC3', 'SLIT group（ n =20） and control group（ n =20）, the SLIT group received a 2-year intervention with a standardized dust mite vaccine SLIT in combination with conventional drugs, the control group received placebo and conventional drug treatment', 'SLIT combined with conventional drug therapy', 'SLIT']","['pre-treatment signs, symptoms, medication scores, age, gender, serum IL-4, TNF-α, and LC3 expression', 'serum levels of IL-4 and TNF-α', 'expressions of serum IL-4 and TNF-α', 'expression of autophagy-related protein LC3', 'Blood samples and inferior turbinate mucosa', 'inflammatory factors and autophagy', 'clinical symptoms, signs and medication scores', 'symptom scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}]","[{'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}, {'cui': 'C0184904', 'cui_str': 'Slitting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0998367', 'cui_str': 'House dust mite'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004391', 'cui_str': 'Autophagocytosis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0225434', 'cui_str': 'Inferior nasal turbinate bone structure'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",40.0,0.0120024,"There were no significant differences in the pre-treatment signs, symptoms, medication scores, age, gender, serum IL-4, TNF-α, and LC3 expression between the SLIT group and the control group（ P >0.05）.","[{'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Department of Otolaryngology，the First Hospital of Changsha，Changsha，410005，China.'}, {'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Otolaryngology，the First Hospital of Changsha，Changsha，410005，China.'}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.03.011']
2544,32791592,[Changes of nasal nitric oxide in the treatment of allergic rhinitis with hydrogen-rich saline lavage of nasal cavity].,"Objective: To observe the effect of hydrogen-rich saline on the concentration of nitric oxide in the nose, and to explore the mechanism of its treatment of allergic rhinitis.  Method: Twenty patients with moderate to severe persistent allergic rhinitis were enrolled in a randomized, double-blind, self-controlled study. The nasal cavity was lavaged with hydrogen-rich normal saline and normal saline, and the nasal nitric oxide（nNO） value was tested weekly.  Result: The test value of nNO was correlated with the diagnosis and curative effect of allergic rhinitis. The difference of nNO test values before and after treatment of the two lavage fluids was statistically significant（ P <0.01）.  Conclusion: Hydrogen-rich saline lavage can cause nNO change in nasal cavity which may be used in the treatment of allergic rhinitis.",2020,The difference of nNO test values before and after treatment of the two lavage fluids was statistically significant（ P <0.01）.  ,"['allergic rhinitis with hydrogen-rich saline lavage of nasal cavity', 'Twenty patients with moderate to severe persistent allergic rhinitis']","['hydrogen-rich normal saline and normal saline', 'hydrogen-rich saline', 'Hydrogen-rich saline lavage']",['nNO test values'],"[{'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0027423', 'cui_str': 'Nasal cavity structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}]","[{'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",20.0,0.0507014,The difference of nNO test values before and after treatment of the two lavage fluids was statistically significant（ P <0.01）.  ,"[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Tongji Hospital，Tongji Medical University（Shanghai Tongji Hospital），Shanghai，200065，China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Fan', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Tongji Hospital，Tongji Medical University（Shanghai Tongji Hospital），Shanghai，200065，China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Tongji Hospital，Tongji Medical University（Shanghai Tongji Hospital），Shanghai，200065，China.'}, {'ForeName': 'Yihua', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Department of Otorhinolaryngology，Zhangqiu Chinese Medicine Hospital，Ji'nan.""}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Ge', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Tongji Hospital，Tongji Medical University（Shanghai Tongji Hospital），Shanghai，200065，China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Tongji Hospital，Tongji Medical University（Shanghai Tongji Hospital），Shanghai，200065，China.'}, {'ForeName': 'Shaoqing', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Tongji Hospital，Tongji Medical University（Shanghai Tongji Hospital），Shanghai，200065，China.'}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.03.014']
2545,32791643,[Efficacy of high dose glucocorticoid in the salvage treatment of sudden deafness].,"Objective: To observe the efficacy and safety of high dose dexamethasone injection in the tympanic cavity in the patients with sudden and severe deafness who failed conventional treatment.  Method: A total of 43 patients with unilateral sudden and severe deafness were recruited in this study. All patients were not cured with conventional comprehensive treatment in the department of otology. They were divided into two groups: 21cases were treated with high dose dexamethasone injection into the tympanic cavity by ventilation tube （dexamethasone group）, while routine treatment was continued in 22 cases （conventional control group）. Each patient underwent a hearing test before treatment, the hearing thresholds of 6 frequencies （0.25, 0.5, 1.0, 2.0, 4.0, 8.0 kHz） were recorded. After one week of treatment, the above-mentioned six frequencies were re-recorded. A decrease of the pure tone threshold average （PTA） more than 15 dB was set for effective.  Result: After 1 week treatment, comparison of the PTA value before and after treatment in dexamethasone group（ t =11.749） and in conventional control group （ t =7.364），comparison of the PTA value of the two groups （ t =-2.628），comparison of the PTA value of hearing improvement between the two groups （ t =2.717）,the differences were statistically significant（ P <0.01 or 0.05）. Sixteen cases in dexamethasone group were effective, the effective rate was 76.2%;10 cases in conventional control group was effective, the effective rate was 45.5%,the difference of the two curative effects was statistically significant（ χ² =3.058, P <0.05）. Eighteen patients in dexamethasone group had vertigo before treatment. The patients were followed up for 6 months after treatment. The vertigo disappeared or decreased in 14 cases, the improve rate is 77.8%.17 patients in the conventional control group had vertigo before treatment, the patients were followed up for 6 months after treatment, the vertigo disappeared or decreased in 6 cases, the improve rate is 35.3%,the difference was statistically significant（ P =0.018）.  Conclusion: High dose dexamethasone injection into the tympanic cavity is more effective than conventional therapy in the salvage treatment of sudden and severe deafness, and it is helpful to improve vertigo.",2020,"Sixteen cases in dexamethasone group were effective, the effective rate was 76.2%;10 cases in conventional control group was effective, the effective rate was 45.5%,the difference of the two curative effects was statistically significant（ χ² =3.058, P <0.05）.","['All patients were not cured with conventional comprehensive treatment in the department of otology', '43 patients with unilateral sudden and severe deafness', 'sudden deafness', 'patients with sudden and severe deafness who failed conventional treatment', 'Eighteen patients in']","['dexamethasone', 'glucocorticoid', 'dexamethasone injection into the tympanic cavity by ventilation tube （dexamethasone', 'dexamethasone injection']","['vertigo', 'vertigo disappeared', 'efficacy and safety', 'hearing improvement', 'effective rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0086746', 'cui_str': 'Otology'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C1276802', 'cui_str': 'Sudden'}, {'cui': 'C3874334', 'cui_str': 'Severe hearing loss'}, {'cui': 'C1148477', 'cui_str': 'Sudden Deafness'}, {'cui': 'C3715206', 'cui_str': '18'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C4283889', 'cui_str': 'Dexamethasone Injection'}, {'cui': 'C0242255', 'cui_str': 'Tympanic cavity structure'}, {'cui': 'C0850121', 'cui_str': 'Tympanic ventilation tube'}]","[{'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}]",43.0,0.0218731,"Sixteen cases in dexamethasone group were effective, the effective rate was 76.2%;10 cases in conventional control group was effective, the effective rate was 45.5%,the difference of the two curative effects was statistically significant（ χ² =3.058, P <0.05）.","[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，the Second Hospital of Baoding，Baoding，071000，China.'}, {'ForeName': 'Jianing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology，Affiliated Hospital of Hebei University.'}, {'ForeName': 'Yajing', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，the Second Hospital of Baoding，Baoding，071000，China.'}, {'ForeName': 'Anping', 'Initials': 'A', 'LastName': 'Luo', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，the Second Hospital of Baoding，Baoding，071000，China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，the Second Hospital of Baoding，Baoding，071000，China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，the Second Hospital of Baoding，Baoding，071000，China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，the Second Hospital of Baoding，Baoding，071000，China.'}, {'ForeName': 'Yongjie', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology，Baoding Xushui District Hospital of Traditional Chinese Medicine.'}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.07.016']
2546,32791665,"Randomized, double-blind, placebo-controlled, parallel-group trial of sirolimus for tocilizumab-resistant idiopathic multicentric Castleman disease: Study protocol for clinical trial.","BACKGROUND


Idiopathic multicentric Castleman disease (iMCD) is a rare lymphoproliferative disorder of unknown etiology with systemic symptoms that include fever, night sweats, weight loss, and fatigue. Although tocilizumab (TCZ), which is a recombinant, humanized, anti-human interleukin 6 receptor monoclonal antibody, has been recommended to treat patients with iMCD, 40% of patients with iMCD do not achieve complete remission with TCZ treatment.
METHODS/DESIGN


In this phase II, investigator-initiated, multicenter, double-blind, randomized, parallel-group trial, the efficacy and safety of sirolimus will be compared with placebo in patients with TCZ-resistant iMCD. The study will be conducted in 8 centers in Japan. Participants (n = 20) will be randomly assigned to receive 2 mg of oral sirolimus (n = 10) or placebo (n = 10) once daily for 16 weeks. The primary endpoint is a decrease in CHAP score by ≥1 from baseline at 16 weeks. Secondary endpoints include levels of hemoglobin, albumin, and C-reactive protein; change in CHAP score; SF-36 Health Survey Questionnaire; physician global assessment (100 mm visual analog scale); patient global assessment (100 mm visual analog scale) at 2, 4, 8, 12, and 16 weeks; change in lymphadenopathy at 16 weeks; and pharmacodynamic assessment, including the measurement of whole blood sirolimus level.
DISCUSSION


This clinical trial will provide evidence of efficacy and safety of sirolimus as a potential new therapeutic agent for patients with TCZ-resistant iMCD.
TRIAL REGISTRATION


This study was registered with the Japan Registry of Clinical Trials as jRCT2071190029 on October 8, 2019.",2020,"Secondary endpoints include levels of hemoglobin, albumin, and C-reactive protein; change in CHAP score; SF-36 Health Survey Questionnaire; physician global assessment (100 mm visual analog scale); patient global assessment (100 mm visual analog scale) at 2, 4, 8, 12, and 16 weeks; change in lymphadenopathy at 16 weeks; and pharmacodynamic assessment, including the measurement of whole blood sirolimus level.
","['Participants (n\u200a=\u200a20', 'patients with TCZ-resistant iMCD', '8 centers in Japan', 'resistant idiopathic multicentric Castleman disease']","['sirolimus', 'tocilizumab', 'oral sirolimus', 'tocilizumab (TCZ', 'placebo']","['lymphadenopathy at 16 weeks; and pharmacodynamic assessment, including the measurement of whole blood sirolimus level', 'efficacy and safety', 'levels of hemoglobin, albumin, and C-reactive protein; change in CHAP score; SF-36 Health Survey Questionnaire; physician global assessment (100\u200amm visual analog scale); patient global assessment (100\u200amm visual analog scale', 'CHAP score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C5197665', 'cui_str': 'HHV-8-negative idiopathic multicentric Castleman disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0497156', 'cui_str': 'Lymphadenopathy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C1618097', 'cui_str': 'Measurement of sirolimus'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0950540', 'cui_str': 'CHAP protocol'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",,0.742216,"Secondary endpoints include levels of hemoglobin, albumin, and C-reactive protein; change in CHAP score; SF-36 Health Survey Questionnaire; physician global assessment (100 mm visual analog scale); patient global assessment (100 mm visual analog scale) at 2, 4, 8, 12, and 16 weeks; change in lymphadenopathy at 16 weeks; and pharmacodynamic assessment, including the measurement of whole blood sirolimus level.
","[{'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Koga', 'Affiliation': 'aDepartment of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences bCenter for Bioinformatics and Molecular Medicine, Nagasaki University Graduate School of Biomedical Sciences cNagasaki University Hospital, Clinical Research Center, Nagasaki, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Hagimori', 'Affiliation': ''}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Takemori', 'Affiliation': ''}, {'ForeName': 'Shimpei', 'Initials': 'S', 'LastName': 'Morimoto', 'Affiliation': ''}, {'ForeName': 'Remi', 'Initials': 'R', 'LastName': 'Sumiyoshi', 'Affiliation': ''}, {'ForeName': 'Toshimasa', 'Initials': 'T', 'LastName': 'Shimizu', 'Affiliation': ''}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Hosogaya', 'Affiliation': ''}, {'ForeName': 'Chizu', 'Initials': 'C', 'LastName': 'Fukushima', 'Affiliation': ''}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': ''}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kawakami', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020710']
2547,32791671,"Effects and safety of intranasal phototherapy for allergic rhinitis: Study protocol for a single-center, randomized, double-blind, parallel, placebo-controlled, investigator-initiated, pilot study.","INTRODUCTION


Allergic rhinitis (AR) is an immunoglobulin E (Ig E)-mediated inflammatory disease. Intranasal phototherapy is a promising treatment modality because it has a profound immunosuppressive effect, but the available evidence of its use for AR is insufficient. Therefore, rigorously designed randomized controlled trials (RCTs) are needed. Our objective is to describe the protocol for a feasibility trial to assess the effects and safety of intranasal phototherapy for the treatment of AR.
METHODS AND ANALYSIS


This is a study protocol for a single-center, randomized, double-blind, parallel, placebo-controlled, investigator-initiated pilot study. A total of 40 patients with AR will be randomly assigned to the medical device or sham device group in a 1:1 ratio. The participants will receive intranasal phototherapy with a medical or sham device for 20 min 5 times a week for 2 weeks. The primary outcome will be the mean change in the Total Nasal Symptom Score (TNSS) from baseline to 2 weeks. The secondary outcomes will include the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score, Nasal Endoscopy Index, total serum Ig E level, and eosinophil count.
DISCUSSION


The findings of this study will provide the basis for subsequent large-scale definitive RCTs to confirm the effects and safety of intranasal phototherapy for the treatment of nasal symptoms in patients with AR who do not respond well to conventional therapy. This study may assist in the development of noninvasive treatment for patients with AR.
TRIAL REGISTRATION


This study was registered at the Korean National Clinical Trial Registry, Clinical Research Information Service (KCT0003253).",2020,The primary outcome will be the mean change in the Total Nasal Symptom Score (TNSS) from baseline to 2 weeks.,"['allergic rhinitis', 'patients with AR', '40 patients with AR', 'patients with AR who do not respond well to conventional therapy']","['intranasal phototherapy', 'Intranasal phototherapy', 'placebo']","['mean change in the Total Nasal Symptom Score (TNSS', 'Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score, Nasal Endoscopy Index, total serum Ig E level, and eosinophil count']","[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C5190490', 'cui_str': 'Intranasal phototherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0189024', 'cui_str': 'Endoscopy of nose'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0856520', 'cui_str': 'Serum immunoglobulin E'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}]",40.0,0.5121,The primary outcome will be the mean change in the Total Nasal Symptom Score (TNSS) from baseline to 2 weeks.,"[{'ForeName': 'Jeongin', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'aDepartment of Ophthalmology, Otolaryngology, and Dermatology, College of Korean Medicine, Woo-Suk University, Jeonju bDepartment of Oriental Rehabilitation, National Rehabilitation Center, Seoul cEvidence-Based Healthcare Research Collaborating Center, Woo-Suk University, Jeonju dFuture Medicine Division, Korea Institute of Oriental Medicine eDepartment of Preventive Medicine, College of Korean Medicine, Daejeon University, Daejeon, Korea.'}, {'ForeName': 'Goeun', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Jeonghun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Youngeun', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Sunju', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Donghyo', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020835']
2548,32791677,The effect of a video-guided educational technology intervention on the academic self-concept of adolescent students with hearing impairment: Implications for physical education.,"BACKGROUND/OBJECTIVE


Academic self-concept is an important construct within the disciplines of medicine, psychology, and education. Enhancing the academic self-concept of students with special educational needs is very crucial because it is associated with their quality of life. This study aimed to examine the effect of a video-guided educational technology intervention on the academic self-concept of adolescents with hearing impairment who were attending inclusive nonresidential public schools in Southeast Nigeria.
METHODS


This study adopted a randomized controlled trial design. The participants were 60 junior secondary students with hearing impairment. We implemented a video-guided educational technology intervention. It relied on the use of 13-minute video clips with captions/subtitles, which covered academic self-concept-related themes. The Academic Self-Concept Questionnaire, which has been developed by Liu and Wang, was used to collect baseline, posttreatment, and follow-up data. We conducted independent-samples and paired t test and computed Cohen d and Glass Δ to analyze the data.
RESULTS


The video-guided educational technology intervention significantly improved the academic self-concept of the treatment group participants, when compared with the care-as-usual control group participants, t(58) = 9.07, P < .001. These improvements in academic self-concept were sustained at follow up among the treatment group participants, when compared with the care-as-usual control group participants, t(48.56) = 10.898, P < .001. Within-subjects comparisons showed that the academic self-concept of the treatment group participants had significantly improved across the different time points at which they were assessed.
CONCLUSION


The video-guided educational technology intervention was effective in improving the academic self-concept of adolescents with hearing impairment who were attending inclusive nonresidential public schools. Large-scale studies are needed to maximize the impact of video-guided educational technology interventions on students with hearing impairments who attend inclusive non residential public schools in Nigeria.",2020,"These improvements in academic self-concept were sustained at follow up among the treatment group participants, when compared with the care-as-usual control group participants, t(48.56) = 10.898, P < .001.","['participants were 60 junior secondary students with hearing impairment', 'adolescents with hearing impairment who were attending inclusive nonresidential public schools', 'students with hearing impairments who attend inclusive non residential public schools in Nigeria', 'adolescent students with hearing impairment', 'adolescents with hearing impairment who were attending inclusive nonresidential public schools in Southeast Nigeria']","['video-guided educational technology interventions', 'video-guided educational technology intervention']",['academic self-concept'],"[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0282570', 'cui_str': 'Technology, Educational'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0036594', 'cui_str': 'Self Concept'}]",60.0,0.0292084,"These improvements in academic self-concept were sustained at follow up among the treatment group participants, when compared with the care-as-usual control group participants, t(48.56) = 10.898, P < .001.","[{'ForeName': 'Uche D', 'Initials': 'UD', 'LastName': 'Asogwa', 'Affiliation': 'aDepartment of Arts Education bDepartment of Educational Foundations cDepartment of Human Kinetics and Health Education dDepartment of Political Science, Alex Ekwueme Federal University Ndufu-Alike Ikwo, Ebonyi State eDepartment of Computer and Robotics Education, University of Nigeria, Nsukka, Enugu State, Nigeria.'}, {'ForeName': 'Theresa O', 'Initials': 'TO', 'LastName': 'Ofoegbu', 'Affiliation': ''}, {'ForeName': 'Chiedu', 'Initials': 'C', 'LastName': 'Eseadi', 'Affiliation': ''}, {'ForeName': 'Chimaobi Samuel', 'Initials': 'CS', 'LastName': 'Ogbonna', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Eskay', 'Affiliation': ''}, {'ForeName': 'Godfrey C', 'Initials': 'GC', 'LastName': 'Nji', 'Affiliation': ''}, {'ForeName': 'Oliver Rotachukwu', 'Initials': 'OR', 'LastName': 'Ngwoke', 'Affiliation': ''}, {'ForeName': 'Victor Chijioke', 'Initials': 'VC', 'LastName': 'Nwosumba', 'Affiliation': ''}, {'ForeName': 'Benardine Ifeoma', 'Initials': 'BI', 'LastName': 'Onah', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021054']
2549,32325004,Early Inspiratory Effort Assessment by Esophageal Manometry Predicts Noninvasive Ventilation Outcome in  De Novo  Respiratory Failure. A Pilot Study.,"Rationale:  The role of inspiratory effort still has to be determined as a potential predictor of noninvasive mechanical ventilation (NIV) failure in acute hypoxic  de novo  respiratory failure. Objectives:  To explore the hypothesis that inspiratory effort might be a major determinant of NIV failure in these patients. Methods:  Thirty consecutive patients with acute hypoxic  de novo  respiratory failure admitted to a single center and candidates for a 24-hour NIV trial were enrolled. Clinical features, tidal change in esophageal pressure (ΔPes), tidal change in dynamic transpulmonary pressure (ΔPl), expiratory Vt, and respiratory rate were recorded on admission and 2-4 to 12-24 hours after NIV start and were tested for correlation with outcomes. Measurements and Main Results:  ΔPes and ΔPes/ΔPl ratio were significantly lower 2 hours after NIV start in patients who successfully completed the NIV trial ( n  = 18) compared with those who needed endotracheal intubation ( n  = 12) (median [interquartile range], 11 [8-15] cm H 2 O vs. 31.5 [30-36] cm H 2 O;  P  < 0.0001), whereas other variables differed later. ΔPes was not related to other predictors of NIV failure at baseline. NIV-induced reduction in ΔPes of 10 cm H 2 O or more after 2 hours of treatment was strongly associated with avoidance of intubation and represented the most accurate predictor of treatment success (odds ratio, 15; 95% confidence interval, 2.8-110;  P  = 0.001 and area under the curve, 0.97; 95% confidence interval, 0.91-1;  P  < 0.0001). Conclusions:  The magnitude of inspiratory effort relief as assessed by ΔPes variation within the first 2 hours of NIV was an early and accurate predictor of NIV outcome at 24 hours.Clinical trial registered with www.clinicaltrials.gov (NCT03826797).",2020,"Measurements and Main Results:  ΔPes and ΔPes/ΔPl ratio were significantly lower 2 hours after NIV start in patients who successfully completed the NIV trial ( n  = 18) compared with those who needed endotracheal intubation ( n  = 12) (median [interquartile range], 11 [8-15] cm H 2 O vs. 31.5",['Thirty consecutive patients with acute hypoxic  de novo  respiratory failure admitted to a single center and candidates for a 24-hour NIV trial were enrolled'],[],"['Noninvasive Ventilation Outcome', 'ΔPes and ΔPes/ΔPl ratio', 'Clinical features, tidal change in esophageal pressure (ΔPes), tidal change in dynamic transpulmonary pressure (ΔPl), expiratory Vt, and respiratory rate']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0751673', 'cui_str': 'Nipah virus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0232531', 'cui_str': 'Esophageal pressure'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}]",30.0,0.374853,"Measurements and Main Results:  ΔPes and ΔPes/ΔPl ratio were significantly lower 2 hours after NIV start in patients who successfully completed the NIV trial ( n  = 18) compared with those who needed endotracheal intubation ( n  = 12) (median [interquartile range], 11 [8-15] cm H 2 O vs. 31.5","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Tonelli', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Fantini', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Tabbì', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Castaniere', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Pisani', 'Affiliation': 'Department of Specialistic, Diagnostic and Experimental Medicine, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Maria Rosaria', 'Initials': 'MR', 'LastName': 'Pellegrino', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Della Casa', 'Affiliation': 'Radiology Unit and.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': ""D'Amico"", 'Affiliation': 'Statistics Unit, Department of Diagnostics, Clinical and Public Health Medicine, and.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Girardis', 'Affiliation': 'Intensive Care Unit, Department of Surgical, Medical, Dental and Morphological Sciences related to Transplants Oncology and Regenerative Medicine, University Hospital of Modena, University of Modena and Reggio Emilia, Modena, Italy; and.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Nava', 'Affiliation': 'Department of Specialistic, Diagnostic and Experimental Medicine, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Enrico M', 'Initials': 'EM', 'LastName': 'Clini', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Marchioni', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201912-2512OC']
2550,32360744,Maternal-fetal disposition of domoic acid following repeated oral dosing during pregnancy in nonhuman primate.,"Domoic acid (DA) is a marine algal toxin that causes acute and chronic neurotoxicity in animals and humans. Prenatal exposure to DA has been associated with neuronal damage and cognitive and behavioral deficits in juvenile California sea lions, cynomolgus monkeys and rodents. Yet, the toxicokinetics (TK) of DA during pregnancy and the maternal-fetal disposition of DA have not been fully elucidated. In this study, we investigated the TK before, during, and after pregnancy and the maternal-fetal disposition of DA in 22 cynomolgus monkeys following daily oral doses of 0.075 or 0.15 mg/kg/day of DA. The AUC 0-τ  of DA was not changed while the renal clearance of DA was increased by 30-90% during and after pregnancy when compared to the pre-pregnancy values. DA was detected in the infant plasma and in the amniotic fluid at delivery. The infant plasma concentrations correlated positively with both the maternal plasma and the amniotic fluid concentrations. The paired infant-to-maternal plasma DA concentration ratios ranged from 0.3 to 0.6 and increased as a function of time which suggests placental efflux and longer apparent fetal half-life than the maternal half-life. The paired amniotic fluid-to-infant plasma DA concentration ratios ranged from 4.5 to 7.5 which indicates significant accumulation of DA in the amniotic fluid. A maternal-fetal TK model was developed to explore the processes that give the observed maternal-fetal disposition of DA. The final model suggests that placental transport and recirculation of DA between the fetus and amniotic fluid are major determining factors of the maternal-fetal TK of DA.",2020,The AUC 0-τ  of DA was not changed while the renal clearance of DA was increased by 30-90% during and after pregnancy when compared to the pre-pregnancy values.,[],['Domoic acid (DA'],"['paired infant-to-maternal plasma DA concentration ratios', 'renal clearance of DA', 'paired amniotic fluid-to-infant plasma DA concentration ratios', 'infant plasma concentrations']",[],"[{'cui': 'C0058678', 'cui_str': 'Amnesic shellfish poison'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0058678', 'cui_str': 'Amnesic shellfish poison'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0232813', 'cui_str': 'Renal clearance'}, {'cui': 'C0002638', 'cui_str': 'Amniotic fluid'}]",,0.0275756,The AUC 0-τ  of DA was not changed while the renal clearance of DA was increased by 30-90% during and after pregnancy when compared to the pre-pregnancy values.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Shum', 'Affiliation': 'Department of Pharmaceutics, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jing', 'Affiliation': 'Department of Pharmaceutics, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'Petroff', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Crouthamel', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Kimberly S', 'Initials': 'KS', 'LastName': 'Grant', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, University of Washington, Seattle, Washington, USA; Infant Primate Research Laboratory, Washington National Primate Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Burbacher', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, University of Washington, Seattle, Washington, USA; Center on Human Development and Disability, University of Washington, Seattle, Washington, USA; Infant Primate Research Laboratory, Washington National Primate Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Isoherranen', 'Affiliation': 'Department of Pharmaceutics, University of Washington, Seattle, Washington, USA; Center on Human Development and Disability, University of Washington, Seattle, Washington, USA. Electronic address: ni2@uw.edu.'}]",Toxicology and applied pharmacology,['10.1016/j.taap.2020.115027']
2551,32791704,"Evaluation of efficacy and safety of single and multiple therapy of herbal medicine/Chuna therapy on non-specific chronic low back pain: A study protocol for multicenter, 3-arm, randomized, single blinded, parallel group, incomplete factorial design, pilot study.","INTRODUCTION


Chronic non-specific low back pain is one of the common health issues which reduce the quality of life and in working population. While combined therapeutic treatment method is widely used for musculoskeletal related disorders in Korea, well-developed trials on the efficacy of single or combine therapy on herbal medicine and Chuna manual therapy (CMT) are scarce.
OBJECTIVE


This study aims to evaluate the clinical efficacy and safety of herbal medicine, Sogyeonghwalhyeol-tang (SGHH) on work related chronic low back pain patients. The primary aim is to determine the efficacy of a combined multidisciplinary approach using SGHH with CMT compared to SGHH alone. The secondary aim is to examine the naïve direct comparison between SGHH and placebo.
METHOD


This trial is designed as a multicenter, randomized, controlled, clinical trial. A total of 150 participants who have with chief complaint of low back pain in Korean medicine rehabilitation center will be randomly assigned to 1 of 3 treatments with a ratio of 1:1:1. Eligible participant will be randomized to treatment arm A receive single treatment of Sogyeonghwalhyeol-tang, in treatment Arm B Sogyeonghwalhyeol-tang and Chuna manual therapy are administered concurrently, in treatment arm C, where individuals receive placebo with Chuna manual therapy. They will receive assigned treatment in 4 weeks and follow-up for 4 weeks. The primary endpoint is to assess the change in severity of low back pain from baseline. The secondary endpoints are the following: the changes in disability and health related quality of life. Adverse events will also be reported.
DISCUSSION


The study result will provide the valuable information for efficacy and safety of monotherapy and multiple therapy of herbal medicinal extract and Chuna manual therapy on chronic non-specific low back pain.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03132974.",2020,The primary aim is to determine the efficacy of a combined multidisciplinary approach using SGHH with CMT compared to SGHH alone.,"['non-specific chronic low back pain', 'chronic low back pain patients', '150 participants who have with chief complaint of low back pain in Korean medicine rehabilitation center']","['herbal medicine, Sogyeonghwalhyeol-tang (SGHH', 'placebo with Chuna manual therapy', 'herbal medicine/Chuna therapy', 'SGHH and placebo', 'Sogyeonghwalhyeol-tang, in treatment Arm B Sogyeonghwalhyeol-tang and Chuna manual therapy', 'herbal medicinal extract and Chuna manual therapy']","['change in severity of low back pain', 'disability and health related quality of life']","[{'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}]","[{'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",150.0,0.222222,The primary aim is to determine the efficacy of a combined multidisciplinary approach using SGHH with CMT compared to SGHH alone.,"[{'ForeName': 'Youme', 'Initials': 'Y', 'LastName': 'Ko', 'Affiliation': 'aDepartment of Science in Korean Medicine, Graduate School, Kyung Hee University, Seoul bDepartment of Korean Rehabilitation Medicine, College of Korean Medicine, Dae-Jeon University, Daejeon cDepartment of Korean Rehabilitation Medicine, College of Korean Medicine, Semyung University, Jecheon dDepartment of Korean Rehabilitation Medicine, College of Korean Medicine, Woosuk University, Jecheon eJaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul fJaseng Hospital of Korean Medicine, Seoul gDepartment of Korean Rehabilitation Medicine, College of Korean Medicine, Gachon University, Seongnam-si, Republic of Korea.'}, {'ForeName': 'Bo-Hyoung', 'Initials': 'BH', 'LastName': 'Jang', 'Affiliation': ''}, {'ForeName': 'Min-Seok', 'Initials': 'MS', 'LastName': 'Oh', 'Affiliation': ''}, {'ForeName': 'Sun Joong', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Yeon-Seok', 'Initials': 'YS', 'LastName': 'Ko', 'Affiliation': ''}, {'ForeName': 'In-Hyuk', 'Initials': 'IH', 'LastName': 'Ha', 'Affiliation': ''}, {'ForeName': 'Eun Jung', 'Initials': 'EJ', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Me-Riong', 'Initials': 'MR', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Yun-Kyung', 'Initials': 'YK', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Seong-Gyu', 'Initials': 'SG', 'LastName': 'Ko', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021260']
2552,32791711,Effect of low frequency repetitive magnetic stimulation at Shenmen (HT7) on sleep quality in patients with chronic insomnia.,"BACKGROUND


Insomnia is a common, recurrent, and tenacious sleep problem, especially the chronic insomnia. Repetitive transcranial magnetic stimulation (rTMS) at right dorsolateral prefrontal cortex (r-DLPFC) is used in chronic insomnia, and repetitive magnetic stimulation (rMS) at Shenmen (HT7) acupoint may be an alternative approach. However, the efficacy and mechanism of rMS at HT7 acupoint for chronic insomnia has not been confirmed.
METHODS/DESIGN


This is a 3-armed randomized positive-controlled noninferiority clinical trial. We will allocate 45 subjects aged between 18 and 65 years old, diagnosed with initial chronic insomnia over 3 months to 3 groups randomly in a ratio of 1:1:1. Patients in the experimental group will be treated with rMS at HT7 acupoint while the others in the control group will be treated with rTMS at r-DLPFC or waiting treatment. All will be given rMS at HT7 or rTMS at r-DLPFC or no treatment for 10 days, and then received 20-day follow-up. Patients will be evaluated with the insomnia severity index and Pittsburgh sleep quality index for sleep state, Beck Depression Inventory-2nd edition scores for the depression state, Beck anxiety inventory scores for the anxiety state, and Montreal Cognitive Assessment scores for the cognition state before and the 10th day of treatment, 30th day of follow-up; study on mechanisms of rMS will be revealed through the resting motor threshold diversity of the motor cortex before and the 10th day of treatment, 30th day of follow-up. Baseline characteristics of patients will be summarized by groups and compared with Chi-squared for categorical variables, and analysis of variance or Kruskal-Wallis test for the continuous variables. Primary and secondary outcomes according to the measurement times are applicable to univariate repetitive measurement deviation analysis or analysis of variance, or Kruskal-Wallis test.
CONCLUSION


The present study is designed to preliminarily investigate short-term efficacy and mechanism of rMS at HT7 acupoint therapy on chronic insomnia, also to explore the correlation between motor cortex excitability and chronic insomnia. With this research, we are looking forward to find out an appropriate alternative and easy therapy for chronic insomnia individuals compared with rTMS at r-DLPFC.
TRIAL REGISTRATION


The trial was registered on Chinese Clinical Trial Registry (http://www.chictr.org.cn/index.aspx) with the ID ChiCTR1900026844 on October 24, 2019.",2020,"The present study is designed to preliminarily investigate short-term efficacy and mechanism of rMS at HT7 acupoint therapy on chronic insomnia, also to explore the correlation between motor cortex excitability and chronic insomnia.","['45 subjects aged between 18 and 65 years old, diagnosed with initial chronic insomnia over 3 months to 3 groups randomly in a ratio of 1:1:1', 'patients with chronic insomnia']","['rMS at HT7 acupoint', 'Repetitive transcranial magnetic stimulation (rTMS', 'repetitive magnetic stimulation (rMS) at Shenmen (HT7) acupoint', 'rMS at HT7 acupoint therapy', 'rTMS at r-DLPFC or waiting treatment', 'HT7 acupoint', 'low frequency repetitive magnetic stimulation at Shenmen (HT7']","['univariate repetitive measurement deviation analysis or analysis of variance, or Kruskal-Wallis test', 'chronic insomnia', 'insomnia severity index and Pittsburgh sleep quality index for sleep state, Beck Depression Inventory-2nd edition scores for the depression state, Beck anxiety inventory scores for the anxiety state, and Montreal Cognitive Assessment scores', 'sleep quality']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0450571', 'cui_str': 'HT7'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0002780', 'cui_str': 'Analysis, Variance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4274492', 'cui_str': 'Beck Anxiety Inventory score'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",45.0,0.0701115,"The present study is designed to preliminarily investigate short-term efficacy and mechanism of rMS at HT7 acupoint therapy on chronic insomnia, also to explore the correlation between motor cortex excitability and chronic insomnia.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': ""aSchool of Basic Medical Sciences, Chengdu University of Traditional Chinese Medicine, Chengdu bDepartment of Encephalopathy, Shaanxi Provincial Hospital of Traditional Chinese Medicine cSyndrome and Treatment Research Office For Insomnia With Yin Yang Sequential Treatment, Shaanxi Administration of Traditional Chinese Medicine dDepartment of Geriatrics, Xi'an Hospital of Traditional Chinese Medicine, Xi'an, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': ''}, {'ForeName': 'Zhaoxin', 'Initials': 'Z', 'LastName': 'Wan', 'Affiliation': ''}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Zucheng', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': ''}, {'ForeName': 'Dongling', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Luo', 'Affiliation': ''}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021292']
2553,32791715,Difference in the metabolic characteristics of chronic obstructive pulmonary disease patients and healthy adults.,"INTRODUCTION


By detecting the metabolic difference of the Heart and Lung meridians, the present study aims to investigate the specificity of different meridians and verify whether functional near infrared spectroscopy is validated as an add-on technique to assist diagnosis of chronic obstructive pulmonary disease (COPD).
METHODS AND ANALYSIS


The Lung and Heart meridians are chosen as the target for comparison; accordingly, 120 eligible participants will be included and divided into the COPD group, healthy control group, and healthy intervention group. Functional near infrared spectroscopy will be adopted to measure the metabolic characteristics of the Heart and Lung meridians. On one hand, the specificity of the meridian-visceral association will be investigated by comparing the metabolic difference in the Heart and Lung meridians between the healthy control group and COPD group. On the other hand, the specificity of site-to-site association will be determined by comparing the metabolic change between the 2 meridians that induced by moxibustion in the Heart meridian and Lung meridian, respectively, in the healthy control group. The primary outcome will be regional oxygen saturation of corresponding regions along the Heart and Lung meridians.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04046666.",2020,"On one hand, the specificity of the meridian-visceral association will be investigated by comparing the metabolic difference in the Heart and Lung meridians between the healthy control group and COPD group.","['120 eligible participants will be included and divided into the COPD group, healthy control group, and healthy intervention group', 'chronic obstructive pulmonary disease (COPD', 'chronic obstructive pulmonary disease patients and healthy adults']",[],['regional oxygen saturation of corresponding regions along the Heart and Lung meridians'],"[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]",[],"[{'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0085282', 'cui_str': 'Jingluo'}]",120.0,0.0505464,"On one hand, the specificity of the meridian-visceral association will be investigated by comparing the metabolic difference in the Heart and Lung meridians between the healthy control group and COPD group.","[{'ForeName': 'Yongliang', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'aDepartment of Neurobiology and Acupuncture Research, The Third Clinical Medical College, Zhejiang Chinese Medical University, Key Laboratory of Acupuncture and Neurology of Zhejiang Province, Hangzhou bThe Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou City, Zhejiang Province, China.'}, {'ForeName': 'Hantong', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Xiaofen', 'Initials': 'X', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Shao', 'Affiliation': ''}, {'ForeName': 'Jiali', 'Initials': 'J', 'LastName': 'Lou', 'Affiliation': ''}, {'ForeName': 'Yajun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Jianqiao', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021302']
2554,32791720,Ear mold for congenital ear malformation: A randomized controlled trial.,"BACKGROUND


Congenital auricular deformities (CAD) are prevalent worldwide. The objective of this study is to investigate the effectiveness and safety of ear molding for children with CAD at their early days.
METHODS


One hundred and nighty children (under 3 days) with CAD will be included in the study. Participants will be randomly allocated to treatment or waiting list group (n = 95). The treatment group will receive ear molding within 3 days after birth for 2 weeks. The control group will receive usual care and receive the same ear molding at 6th week if spontaneously recover is not occur. Physician and parent assessment of improvement, parent's anxiety, depression, and quality of life and adverse events will be measured at baseline, 3rd and 6th week of initial treatment. The primary outcome recovery rate will be compared between groups using Chi square test. Secondary continuous outcomes will be compared using analysis of variance.
DISCUSSION


This study is the first randomized controlled trial to examine the effectiveness, safety and cost-effectiveness of ear molding for CAD comparing with waiting list, to inform clinical decision of CAD treatments and relevant guideline development.",2020,"This study is the first randomized controlled trial to examine the effectiveness, safety and cost-effectiveness of ear molding for CAD comparing with waiting list, to inform clinical decision of CAD treatments and relevant guideline development.","['One hundred and nighty children (under 3 days) with CAD will be included in the study', 'children with CAD at their early days', 'Congenital auricular deformities (CAD', 'ear malformation']",['waiting list group'],"['effectiveness, safety and cost-effectiveness', 'recovery rate', ""Physician and parent assessment of improvement, parent's anxiety, depression, and quality of life and adverse events""]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0266589', 'cui_str': 'Congenital malformation of ear'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.171539,"This study is the first randomized controlled trial to examine the effectiveness, safety and cost-effectiveness of ear molding for CAD comparing with waiting list, to inform clinical decision of CAD treatments and relevant guideline development.","[{'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zou', 'Affiliation': ""aDepartment of Health Policy and Management bWest China Research Centre for Rural Health Development, West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, Sichuan cNational Center for Women and Children's Health, China Center for Disease Control and Prevention, Beijing dDepartment of Health-Related Social and Behavioral Sciences eDepartment of Epidemiology and Biostatistics, West China School of Public Health and West China Fourth Hospital, Sichuan University fDepartment of Pharmacy, West China Second Hospital, Sichuan University gEvidence-Based Pharmacy Center, West China Second Hospital, Sichuan University, Chengdu, Sichuan, China hFaculty of Health, Art and Design, Swinbune Technology University, Melbourne, Australia.""}, {'ForeName': 'Yanjun', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': ''}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'Jincheng', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Yunqi', 'Initials': 'Y', 'LastName': 'Miao', 'Affiliation': ''}, {'ForeName': 'Chunsong', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021313']
2555,32791721,Maternal bacteria to correct abnormal gut microbiota in babies born by C-section.,"INTRODUCTION


There is evidence that caesarean section (CS) is associated with increased risk of childhood obesity, asthma, and coeliac disease. The gut microbiota of CS-born babies differs to those born vaginally, possibly due to reduced exposure to maternal vaginal bacteria during birth. Vaginal seeding is a currently unproven practice intended to reduce such differences, so that the gut microbiota of CS-born babies is similar to that of babies born vaginally. Our pilot study, which uses oral administration as a novel form of vaginal seeding, will assess the degree of maternal strain transfer and overall efficacy of the procedure for establishing normal gut microbiota development.
METHODS AND ANALYSIS


Protocol for a single-blinded, randomized, placebo-controlled pilot study of a previously untested method of vaginal seeding (oral administration) in 30 CS-born babies. A sample of maternal vaginal bacteria is obtained prior to CS, and mixed with 5 ml sterile water to obtain a supernatant. Healthy babies are randomized at 1:1 to receive active treatment (3 ml supernatant) or placebo (3 ml sterile water). A reference group of 15 non-randomized vaginal-born babies are also being recruited. Babies' stool samples will undergo whole metagenomic shotgun sequencing to identify potential differences in community structure between CS babies receiving active treatment compared to those receiving placebo at age 1 month (primary outcome). Secondary outcomes include differences in overall gut community between CS groups (24 hours, 3 months); similarity of CS-seeded and placebo gut profiles to vaginally-born babies (24 hours, 1 and 3 months); degree of maternal vaginal strain transfer in CS-born babies (24 hours, 1 and 3 months); anthropometry (1 and 3 months) and body composition (3 months).
ETHICS AND DISSEMINATION


Ethics approval by the Northern A Health and Disability Ethics Committee (18/NTA/49). Results will be published in peer-reviewed journals and presented at international conferences.
REGISTRATION


Australian New Zealand Clinical Trials Registry (ACTRN12618000339257).",2020,"The gut microbiota of CS-born babies differs to those born vaginally, possibly due to reduced exposure to maternal vaginal bacteria during birth.","['15 non-randomized vaginal-born babies', '30 CS-born babies', 'Healthy babies', 'babies born by C-section']","['vaginal seeding (oral administration', 'placebo']","['overall gut community between CS groups (24\u200ahours, 3 months); similarity of CS-seeded and placebo gut profiles to vaginally-born babies (24\u200ahours, 1 and 3 months); degree of maternal vaginal strain transfer']","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}]",,0.193941,"The gut microbiota of CS-born babies differs to those born vaginally, possibly due to reduced exposure to maternal vaginal bacteria during birth.","[{'ForeName': 'Éadaoin M', 'Initials': 'ÉM', 'LastName': 'Butler', 'Affiliation': ""aA Better Start - National Science Challenge bLiggins Institute, University of Auckland, Auckland, New Zealand cNeonatal Intensive Care Unit, Pescara Public Hospital, Pescara, Italy dDepartment of Women's and Children's Health, Uppsala University, Uppsala, Sweden eEndocrinology Department, Children's Hospital of Zhejiang University School of Medicine, Hangzhou, China fDepartment of Obstetrics and Gynaecology, Auckland City Hospital, Auckland District Health Board, New Zealand.""}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Chiavaroli', 'Affiliation': ''}, {'ForeName': 'José G B', 'Initials': 'JGB', 'LastName': 'Derraik', 'Affiliation': ''}, {'ForeName': 'Celia P', 'Initials': 'CP', 'LastName': 'Grigg', 'Affiliation': ''}, {'ForeName': 'Brooke C', 'Initials': 'BC', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Walker', 'Affiliation': ''}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'OʼSullivan', 'Affiliation': ''}, {'ForeName': 'Wayne S', 'Initials': 'WS', 'LastName': 'Cutfield', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021315']
2556,32791810,"[Phase Ⅲ randomized controlled, multicenter, prospective study of recombinant anti-HER2 humanized monoclonal antibody (Cipterbin) combined with vinorelbine in patients with HER2 positive metastatic breast cancer: the HOPES Study].","Objective:  To evaluate the clinical efficacy and safety of recombinant anti-HER2 humanized monoclonal antibody (Cipterbin) combined with vinorelbine in patients with HER2 positive metastatic breast cancer.  Methods:  Patients were randomized 2∶1 to test group and control group. Patients in test group received Cipterbin (4 mg/kg loading dose and 2 mg/kg maintenance dose each week, IV) combined with vinorelbine (25 mg/m(2) on days 1,8 and 15 of each 28 days, IV). Patients in control group received vinorelbine (25 mg/m(2) on days 1,8 and 15 of each 28 days, IV).The primary end point was progression free survival (PFS).  Results:  A total of 315 patients were enrolled from Jan 2009 to Jan 2013 (212 in test group and 103 in control group). The median PFS of test group was significantly longer than that of control group, 39.1 weeks vs 14.0 weeks ( HR =0.24; 95 %CI , 0.16-0.36;  P< 0.000 1). The objective response rate (ORR) and disease control rate (DCR) in test group were significantly higher than those in control group, ORR was 46.7% vs 18.45% ( P< 0.000 1) and DCR was 79.72% vs 45.63% ( P< 0.000 1). The incidence of neutropenia, leucopenia and erythrocytopenia were higher in both groups, but there was no significant difference between two groups.The most common adverse events associated with Cipterbin were infusion reactions. Left ventricular ejection fraction reduced to less than 50% in 5 patients, which were recovered. No serious cardiotoxicity.  Conclusion:  The recombinant anti-HER2 humanized monoclonal antibody (Cipterbin) combined with vinorelbine has significant efficacy and good safety. It is the optimized therapy regime for patients with taxane-pretreated HER2 positive metastatic breast cancer, which provides more targeted therapy opportunities for HER2 positive breast cancer patients in China.",2020,"The incidence of neutropenia, leucopenia and erythrocytopenia were higher in both groups, but there was no significant difference between two groups.","['patients with taxane-pretreated HER2 positive metastatic breast cancer', 'HER2 positive breast cancer patients in China', 'patients with HER2 positive metastatic breast cancer', '315 patients were enrolled from Jan 2009 to Jan 2013 (212 in test group and 103 in control group']","['recombinant anti-HER2 humanized monoclonal antibody (Cipterbin) combined with vinorelbine', 'vinorelbine', 'Cipterbin']","['progression free survival (PFS', 'incidence of neutropenia, leucopenia and erythrocytopenia', 'ORR', 'median PFS', 'Left ventricular ejection fraction', 'objective response rate (ORR) and disease control rate (DCR', 'DCR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C4721209', 'cui_str': 'Metastatic human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0221395', 'cui_str': 'Erythropenia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}]",315.0,0.0281007,"The incidence of neutropenia, leucopenia and erythrocytopenia were higher in both groups, but there was no significant difference between two groups.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bian', 'Affiliation': 'Department of Breast Oncology, the Fifth Medical Center of Chinese PLA General Hospital, Beijing 100070, China.'}, {'ForeName': 'B H', 'Initials': 'BH', 'LastName': 'Xu', 'Affiliation': 'Cancer Hospital, Chinese Academy of Medical Sciences, Beijing 100021, China.'}, {'ForeName': 'L J', 'Initials': 'LJ', 'LastName': 'Di', 'Affiliation': 'Peking University Cancer Hospital & Institute, Beijing 100038, China.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Breast Oncology, the Fifth Medical Center of Chinese PLA General Hospital, Beijing 100070, China.'}, {'ForeName': 'X J', 'Initials': 'XJ', 'LastName': 'Wang', 'Affiliation': 'Zhejiang Cancer Hospital, Hangzhou310000, China.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Jiao', 'Affiliation': 'The First Medical Center of Chinese PLA General Hospital, Beijing 100853, China.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Yang', 'Affiliation': 'The First Medical Center of Chinese PLA General Hospital, Beijing 100853, China.'}, {'ForeName': 'Z S', 'Initials': 'ZS', 'LastName': 'Tong', 'Affiliation': 'Tianjin Medical University Cancer Institute and Hospital, Tianjin 300060, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Fujian Cancer Hospital, Fuzhou 350011, China.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Feng', 'Affiliation': 'Jiangsu Cancer Hospital, Nanjing 210009, China.'}, {'ForeName': 'D G', 'Initials': 'DG', 'LastName': 'Liu', 'Affiliation': 'Sun Yat-sen University Cancer Center, Guangzhou 510080, China.'}, {'ForeName': 'Q T', 'Initials': 'QT', 'LastName': 'Yu', 'Affiliation': 'Guangxi Medical University Affiliated Cancer Hospital, Nanning 530021, China.'}, {'ForeName': 'Y P', 'Initials': 'YP', 'LastName': 'Liu', 'Affiliation': 'The First Hospital of China Medical University, Shenyang110001, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Sunshine Guojian Pharmaceutical(Shanghai)Co., Ltd, Shanghai 200090, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing 210002 China.'}, {'ForeName': 'Z F', 'Initials': 'ZF', 'LastName': 'Jiang', 'Affiliation': 'Department of Breast Oncology, the Fifth Medical Center of Chinese PLA General Hospital, Beijing 100070, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20200116-00105']
2557,32791881,Symptom Burden and Unmet Needs in MPM: Exploratory Analyses From the RESPECT-Meso Study.,"OBJECTIVE


Malignant Pleural Mesothelioma (MPM) has a poor prognosis and high symptom burden. RESPECT-Meso was a multicenter randomized study examining the role of early specialist palliative care (SPC) on quality of life (QoL) with MPM. This is a post-hoc exploratory analysis of the symptom burden and unmet needs identified from RESPECT-Meso participants.
METHODS


Exploratory analysis from 174 participants using the General Health Status (GHS) measure (from the EORTC QLQ-C30 QoL questionnaire) and 87 participants using validated assessment questionnaires in those randomized to SPC. Eligibility for the study included confirmed MPM with diagnosis <6 weeks prior, performance score (PS) 0 or 1, no significant physical or psychological comorbidity. Cox proportional hazards models were derived to examine for relationships with survival. Free text was assessed using content analysis, looking for common themes and words.
RESULTS


Participants were predominantly male (79.9%), mean age 72.8 years, PS was 0 in 38%, 78% of MPM was epithelioid. At least 3 symptoms were reported in 69.8% of participants, including fatigue (81%), dyspnea (73.3%), pain (61.2%), weight loss (59.3%). Anxiety was reported by 54.7% of participants, 52.3% low mood and 48.8% anhedonia symptoms. After multivariable adjustment, only pain remained statistically significant with a hazard ratio (HR) 2.9 (95% CI 1.3-6.7; p = 0.01). For each 1 unit increase in GHS score, the HR for death was 0.987 (0.978-0.996; p = 0.006), indicating a worse reported QoL is related to shorter survival. Unmet needs were common: 25.9% wanted more information about their condition, 24.7% about their care and 21.2% about their treatment. 79.1% were concerned about the effect of their illness on family.
CONCLUSION


There is a high symptom burden in mesothelioma despite good baseline performance status. A worse QoL is associated with a worse survival. Unmet needs are common, perhaps highlighting a need for improved communication and information sharing.",2020,"After multivariable adjustment, only pain remained statistically significant with a hazard ratio (HR) 2.9","['Participants were predominantly male (79.9%), mean age 72.8 years, PS was 0 in 38%, 78% of MPM was epithelioid', '174 participants using the General Health Status (GHS) measure (from the EORTC QLQ-C30 QoL questionnaire) and 87 participants using validated assessment questionnaires in those randomized to SPC']",['early specialist palliative care (SPC'],"['quality of life (QoL', 'fatigue', 'Anxiety', 'weight loss', 'dyspnea', 'GHS score, the HR for death', 'pain']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1273400', 'cui_str': 'Specialist palliative care'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1273400', 'cui_str': 'Specialist palliative care'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",174.0,0.171703,"After multivariable adjustment, only pain remained statistically significant with a hazard ratio (HR) 2.9","[{'ForeName': 'Siao Nge', 'Initials': 'SN', 'LastName': 'Hoon', 'Affiliation': 'Department of Respiratory Medicine, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Lawrie', 'Affiliation': 'Department of Palliative Medicine, North Manchester General Hospital, Manchester, United Kingdom.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Qi', 'Affiliation': 'Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Najib', 'Initials': 'N', 'LastName': 'Rahman', 'Affiliation': 'Oxford Respiratory Trials Unit, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Maskell', 'Affiliation': 'Department of Respiratory Medicine, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Forbes', 'Affiliation': 'Department of Palliative Medicine, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gerry', 'Affiliation': 'Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Monterosso', 'Affiliation': 'School of Nursing and Midwifery, University of Notre Dame, Fremantle, Australia.'}, {'ForeName': 'Anoop', 'Initials': 'A', 'LastName': 'Chauhan', 'Affiliation': 'Department of Respiratory Medicine, Portsmouth Hospitals NHS Trust, Portsmouth, United Kingdom.'}, {'ForeName': 'Fraser J H', 'Initials': 'FJH', 'LastName': 'Brims', 'Affiliation': 'Department of Respiratory Medicine, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.'}]",Journal of palliative care,['10.1177/0825859720948975']
2558,32791888,How are body mass and body attitude impacted by a behaviour change intervention in primary care? A pragmatic randomised controlled trial.,"Aims: This study evaluated the effect of behaviour change interventions at Norwegian Healthy Life Centres on change in body mass index (BMI) and body attitude, and explored the predictors for change after 6 months.  Methods:  We randomised 118 participants to either an intervention or a control group. Eligible participants: ⩾18 years and able to take part in group-based interventions. Body attitude, weight, and height were assessed at inclusion and after 6 months. We analysed the data using simple and multiple regression.  Results:  Eighty-six participants completed 6-month follow-up. The study found no intervention effect on BMI or body attitude across the two groups. However, an interaction effect indicated that the leaner participants in the intervention group reduced their weight significantly ( b  0.94,  p  < 0.001). BMI reduction was predicted by self-efficacy for physical activity and autonomous motivation for change. Weight loss was associated with impaired body attitude, body shape concern, impaired weight-related self-esteem, weight cycling, and controlled motivation for change. Improvement in body attitude was positively impacted by self-rated health, the experience of childhood respect, life satisfaction, and self-efficacy for physical activity. Impaired body attitude was predicted by body shape concern, impaired weight-related self-esteem, and controlled motivation.  Conclusions:  The interventions did not affect body mass on average, but promoted weight loss among the leaner participants. Because weight reduction was associated body shape concern and impaired body attitude, the study supports the claim that interventions should be weight neutral and aim to improve body image and psychological well-being rather than weight reduction.",2020,"Weight loss was associated with impaired body attitude, body shape concern, impaired weight-related self-esteem, weight cycling, and controlled motivation for change.","['Eligible participants: ⩾18 years and able to take part in group-based interventions', '118 participants to either an intervention or a control group', 'Eighty-six participants completed 6-month follow-up']",['behaviour change interventions'],"['Body attitude, weight, and height', 'weight', 'Weight loss', 'BMI or body attitude', 'self-rated health, the experience of childhood respect, life satisfaction, and self-efficacy for physical activity', 'body attitude', 'impaired body attitude, body shape concern, impaired weight-related self-esteem, weight cycling, and controlled motivation', 'weight loss', 'Impaired body attitude', 'BMI reduction', 'body mass index (BMI) and body attitude']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",118.0,0.0587673,"Weight loss was associated with impaired body attitude, body shape concern, impaired weight-related self-esteem, weight cycling, and controlled motivation for change.","[{'ForeName': 'Gro Beate', 'Initials': 'GB', 'LastName': 'Samdal', 'Affiliation': 'VID Specialized University, Faculty of Health, Bergen, Norway.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Bezuijen', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Norway.'}, {'ForeName': 'Øyvin Noddeland', 'Initials': 'ØN', 'LastName': 'Mongstad', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Norway.'}, {'ForeName': 'Geir Egil', 'Initials': 'GE', 'LastName': 'Eide', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Norway.'}, {'ForeName': 'Eirik', 'Initials': 'E', 'LastName': 'Abildsnes', 'Affiliation': 'Kristiansand Municipality, Kristiansand, Norway.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mildestvedt', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Norway.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Meland', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Norway.'}]",Scandinavian journal of public health,['10.1177/1403494820939027']
2559,32791973,"Nicotinamide riboside with pterostilbene (NRPT) increases NAD +  in patients with acute kidney injury (AKI): a randomized, double-blind, placebo-controlled, stepwise safety study of escalating doses of NRPT in patients with AKI.","BACKGROUND


Preclinical studies have identified both NAD +  and sirtuin augmentation as potential strategies for the prevention and treatment of AKI. Nicotinamide riboside (NR) is a NAD +  precursor vitamin and pterostilbene (PT) is potent sirtuin activator found in blueberries. Here, we tested the effect of combined NR and PT (NRPT) on whole blood NAD +  levels and safety parameters in patients with AKI.
METHODS


We conducted a randomized, double-blind, placebo-controlled study of escalating doses of NRPT in 24 hospitalized patients with AKI. The study was comprised of four Steps during which NRPT (5 subjects) or placebo (1 subject) was given twice a day for 2 days. NRPT dosing was increased in each Step: Step 1250/50 mg, Step 2500/100 mg, Step 3750/150 mg and Step 41,000/200 mg. Blood NAD +  levels were measured by liquid chromatography-mass spectrometry and safety was assessed by history, physical exam, and clinical laboratory testing.
RESULTS


AKI resulted in a 50% reduction in whole blood NAD +  levels at 48 h compared to 0 h in patients receiving placebo (p = 0.05). There was a trend for increase in NAD +  levels in all NRPT Steps individually at 48 h compared to 0 h, but only the change in Step 2 reached statistical significance (47%, p = 0.04), and there was considerable interindividual variability in the NAD +  response to treatment. Considering all Steps together, NRPT treatment increased NAD +  levels by 37% at 48 h compared to 0 h (p = 0.002). All safety laboratory tests were unchanged by NRPT treatment, including creatinine, estimated glomerular filtration rate (eGFR), electrolytes, liver function tests, and blood counts. Three of 20 patients receiving NRPT reported minor gastrointestinal side effects.
CONCLUSION


NRPT increases whole blood NAD +  levels in hospitalized patients with AKI. In addition, NRPT up to a dose of 1000 mg/200 mg twice a day for 2 days is safe and well tolerated in these patients. Further studies to assess the potential therapeutic benefit of NRPT in AKI are warranted.
TRIAL REGISTRATION


NCT03176628 , date of registration June 5th, 2017.",2020,"There was a trend for increase in NAD +  levels in all NRPT Steps individually at 48 h compared to 0 h, but only the change in Step 2 reached statistical significance (47%, p = 0.04), and there was considerable interindividual variability in the NAD +  response to treatment.","['patients with AKI', '20 patients receiving', '24 hospitalized patients with AKI', 'hospitalized patients with AKI', 'patients with acute kidney injury (AKI']","['Nicotinamide riboside (NR', 'NAD +  precursor vitamin and pterostilbene (PT', 'Nicotinamide riboside with pterostilbene (NRPT', 'combined NR and PT (NRPT', 'NRPT', 'placebo']","['Blood NAD +  levels', 'whole blood NAD +  levels', 'blood NAD +  levels', 'whole blood NAD +  levels and safety parameters', 'gastrointestinal side effects', 'safe and well tolerated', 'NAD +  levels', 'creatinine, estimated glomerular filtration rate (eGFR), electrolytes, liver function tests, and blood counts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0068711', 'cui_str': 'nicotinamide-beta-riboside'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0664965', 'cui_str': 'pterostilbene'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0023901', 'cui_str': 'Hepatic function panel'}, {'cui': 'C0005771', 'cui_str': 'Blood cell count'}]",24.0,0.374567,"There was a trend for increase in NAD +  levels in all NRPT Steps individually at 48 h compared to 0 h, but only the change in Step 2 reached statistical significance (47%, p = 0.04), and there was considerable interindividual variability in the NAD +  response to treatment.","[{'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Simic', 'Affiliation': 'Division of Nephrology and Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. psimic@partners.org.'}, {'ForeName': 'Xavier Fernando', 'Initials': 'XF', 'LastName': 'Vela Parada', 'Affiliation': 'Division of Nephrology and Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Samir M', 'Initials': 'SM', 'LastName': 'Parikh', 'Affiliation': 'Division of Nephrology and Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Dellinger', 'Affiliation': 'Elysium Health Inc., New York, NY, USA.'}, {'ForeName': 'Leonard P', 'Initials': 'LP', 'LastName': 'Guarente', 'Affiliation': 'Elysium Health Inc., New York, NY, USA.'}, {'ForeName': 'Eugene P', 'Initials': 'EP', 'LastName': 'Rhee', 'Affiliation': 'Department of Biology, Massachusetts Institute of Technology, Cambridge, MA, USA.'}]",BMC nephrology,['10.1186/s12882-020-02006-1']
2560,32791985,"A monocentric, open-label randomized standard-of-care controlled study of XONRID®, a medical device for the prevention and treatment of radiation-induced dermatitis in breast and head and neck cancer patients.","BACKGROUND


This study was an open-label, 2-arms, monocentric, randomized clinical trial comparing Xonrid®, a topical medical device, versus standard of care (SOC) in preventing and treating acute radiation dermatitis (ARD) in Head and Neck Cancer (HNC) and Breast Cancer (BC) patients undergoing radiotherapy (RT).
METHODS


Eligible HNC and BC patients were randomized 1:1 to receive Xonrid® + SOC or SOC during RT. Patients were instructed to apply Xonrid® on the irradiated area three times daily, starting on the first day of RT and until 2 weeks after RT completion or until the development of grade ≥ 3 skin toxicity. The primary endpoint was to evaluate the proportion of patients who developed an ARD grade < 2 at the 5th week in both groups. Secondary endpoints were median time to grade 2 (G2) skin toxicity onset; changes in skin erythema and pigmentation and trans-epidermal water loss (TEWL); patient-reported skin symptoms. All patients were evaluated at baseline, weekly during RT and 2 weeks after treatment completion. The evaluation included: clinical toxicity assessment; reflectance spectrometry (RS) and TEWL examination; measurement of patients' quality of life (QoL) through Skindex-16 questionnaire.
RESULTS


Eighty patients (40 for each cancer site) were enrolled between June 2017 and July 2018. Groups were well balanced for population characteristics. All BC patients underwent 3-Dimensional Conformal RT (3D-CRT) whereas HNC patients underwent Volumetric-Modulated Arc Therapy (VMAT). At week 5 the proportion of BC patients who did not exhibit G2 ARD was higher in Xonrid® + SOC group (p = 0.091). In the same group the onset time of G2 ARD was significantly longer than in SOC-alone group (p < 0.0491). For HNC groups there was a similar trend, but it did not reach statistical significance. For both cancer sites, patients' QoL, measured by the Skindex-16 score, was always lower in the Xonrid® + SOC group.
CONCLUSION


Despite the failure to achieve the primary endpoint, this study suggests that Xonrid® may represent a valid medical device in the prevention and treatment of ARD at least in BC patients, delaying time to develop skin toxicity and reducing the proportion of patients who experienced G2 ARD during RT treatment and 2 weeks later.
TRIAL REGISTRATION


The study was approved by the Ethical Committee of Fondazione IRCCS Istituto Nazionale dei Tumori di Milano (INT 52/14 - NCT02261181 ). Registered on ClinicalTrial.gov on 21st August 2017.",2020,"For both cancer sites, patients' QoL, measured by the Skindex-16 score, was always lower in the Xonrid® + SOC group.
","['Eighty patients (40 for each cancer site) were enrolled between June 2017 and July 2018', 'breast and head and neck cancer patients', 'acute radiation dermatitis (ARD) in Head and Neck Cancer (HNC) and Breast Cancer (BC) patients undergoing radiotherapy (RT', 'Eligible HNC and BC patients']","['standard of care (SOC', 'HNC patients underwent Volumetric-Modulated Arc Therapy (VMAT', 'Xonrid®\u2009+\u2009SOC or SOC during RT', 'XONRID®', '3-Dimensional Conformal RT (3D-CRT']","['onset time of G2 ARD', 'G2 ARD', 'proportion of patients who developed an ARD grade\u2009<\u20092', ""clinical toxicity assessment; reflectance spectrometry (RS) and TEWL examination; measurement of patients' quality of life (QoL) through Skindex-16 questionnaire"", 'median time to grade 2 (G2) skin toxicity onset; changes in skin erythema and pigmentation and trans-epidermal water loss (TEWL); patient-reported skin symptoms', 'skin toxicity']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0263606', 'cui_str': 'Early radiation dermatitis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0600521', 'cui_str': 'Conformal radiotherapy'}, {'cui': 'C0026377', 'cui_str': 'Molecular conformation'}]","[{'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0263606', 'cui_str': 'Early radiation dermatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0436196', 'cui_str': 'Spectrometry'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0586407', 'cui_str': 'Skin symptom'}]",,0.0445439,"For both cancer sites, patients' QoL, measured by the Skindex-16 score, was always lower in the Xonrid® + SOC group.
","[{'ForeName': 'Rossana', 'Initials': 'R', 'LastName': 'Ingargiola', 'Affiliation': 'Radiation Oncology Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Via Venezian 1, 20133, Milan, Italy.'}, {'ForeName': 'Maria Carmen', 'Initials': 'MC', 'LastName': 'De Santis', 'Affiliation': 'Radiation Oncology Unit 1, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Nicola Alessandro', 'Initials': 'NA', 'LastName': 'Iacovelli', 'Affiliation': 'Radiation Oncology Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Via Venezian 1, 20133, Milan, Italy. nicolaalessandro.iacovelli@istitutotumori.mi.it.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Facchinetti', 'Affiliation': 'Radiation Oncology Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Via Venezian 1, 20133, Milan, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Cavallo', 'Affiliation': 'Medical Physics Unit, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Ivaldi', 'Affiliation': 'Radiation Oncology Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Via Venezian 1, 20133, Milan, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Dispinzieri', 'Affiliation': 'Radiation Oncology Unit 1, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Marzia', 'Initials': 'M', 'LastName': 'Franceschini', 'Affiliation': 'Radiation Oncology Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Via Venezian 1, 20133, Milan, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Giandini', 'Affiliation': 'Radiation Oncology Unit 1, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Domenico Attilio', 'Initials': 'DA', 'LastName': 'Romanello', 'Affiliation': 'Radiation Oncology Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Via Venezian 1, 20133, Milan, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Di Biaso', 'Affiliation': 'Medical Physics Unit, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Sabetti', 'Affiliation': 'Medical Physics Unit, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Locati', 'Affiliation': 'Head and Neck Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Alfieri', 'Affiliation': 'Head and Neck Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bossi', 'Affiliation': 'Medical Oncology, University of Brescia, ASST-Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Guglielmo', 'Affiliation': 'Oncology-Supportive Care Unit, Fondazione IRCCS, Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Macchi', 'Affiliation': 'Helsinn Healthcare SA, Lugano, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lozza', 'Affiliation': 'Radiation Oncology Unit 1, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Valdagni', 'Affiliation': 'Radiation Oncology Unit 1, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Fallai', 'Affiliation': 'Radiation Oncology Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Via Venezian 1, 20133, Milan, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Pignoli', 'Affiliation': 'Medical Physics Unit, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Orlandi', 'Affiliation': 'Radiation Oncology Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Via Venezian 1, 20133, Milan, Italy.'}]","Radiation oncology (London, England)",['10.1186/s13014-020-01633-0']
2561,32792033,"The Effect of a Simulated Fire Disaster Psychological First Aid Training Program on the Self-efficacy, Competence, and Knowledge of Mental Health Practitioners.","OBJECTIVE


This study developed a simulation program using standardized patients for the training of mental health practitioners in psychological first aid and evaluated its effect on learners' self-efficacy and psychological first aid performance competence and knowledge. The simulation used in this program was of a fire disaster.
METHODS


Thirty participants were randomly assigned to an experimental group, a comparison group, and a control group. The experimental group participated in simulation training after attending a two-hour psychological first aid lecture. The comparison group was given only the two-hour lecture and the control group was given a psychological first aid handout to study individually. The results of pre- and post-intervention questionnaires were then statistically analyzed.
RESULTS


The participants' self-efficacy, performance competency, and knowledge improved in all groups, and there were some statistically significant differences between the three groups. The experimental group showed a greater improvement in self-efficacy and performance than the other groups.
CONCLUSIONS


The psychological first aid simulation training program was effective in improving three qualities of mental health practitioners: self-efficacy, performance competency, and knowledge. Further research is required for the development of various learning scenarios for iterative psychological first aid education.",2020,"The psychological first aid simulation training program was effective in improving three qualities of mental health practitioners: self-efficacy, performance competency, and knowledge.","['standardized patients for the training of mental health practitioners in psychological first aid', 'mental health practitioners', 'Thirty participants']","['simulation training', 'Simulated Fire Disaster Psychological First Aid Training Program']","['self-efficacy, performance competency, and knowledge', 'self-efficacy and performance', ""learners' self-efficacy and psychological first aid performance competence and knowledge"", 'Self-efficacy, Competence, and Knowledge of Mental Health Practitioners']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0016143', 'cui_str': 'First aid'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0016141', 'cui_str': 'Fires'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1276379', 'cui_str': 'First aid education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0016143', 'cui_str': 'First aid'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",30.0,0.0131099,"The psychological first aid simulation training program was effective in improving three qualities of mental health practitioners: self-efficacy, performance competency, and knowledge.","[{'ForeName': 'Jung Suk', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Graduate School of Nursing and Health Professions, Chung-Ang University, Seoul, South Korea.'}, {'ForeName': 'Yun-Jung', 'Initials': 'YJ', 'LastName': 'Choi', 'Affiliation': 'Red Cross College of Nursing, Chung-Ang University, Seoul, South Korea.'}]",Disaster medicine and public health preparedness,['10.1017/dmp.2020.184']
2562,32792131,[PECS I block for postoperative analgesia in patients undergoing breast augmentation surgery: a randomized double-blind placebo-controlled study].,"BACKGROUND AND OBJECTIVES


PECS I block was first described for surgery involving the pectoralis muscles. No randomized clinical trial has been conducted on surgeries that directly involve these muscles, such as subpectoral breast augmentation. We hypothesized that PECS I block would decrease pain in the postoperative period in this population.
METHODS


This was a randomized, double-blind, placebo-controlled trial in women undergoing subpectoral breast augmentation surgery. PECS I block was performed using 0.4 mL.kg -1  of 0.9% saline on one side and bupivacaine (0.25%) on the other side, each patient being her own control. Numeric Rating Scale (NRS) pain scores (0-10) were measured at rest and during movement. The primary outcome was pain score at rest 30 minutes after arrival in the PACU. To detect a clinically significant difference of 50% in pain reduction, 14 volunteers were enrolled (power of 90% and alpha<0.05).
RESULTS


In the PACU, three patients had no difference in pain between sides, five had reduced pain on the placebo side, and six had reduced pain on the bupivacaine side. In the bupivacaine group, pain scores at rest at 5, 30 and 60 minutes and 24 hours were 4.89 (4.23-5.56; mean 95% CI), 3.75 (3.13-4.37), 3.79 (2.93-4.64), and 2.29 (1.56-3.01), respectively, whereas in the placebo group, they were 4.96 (4.32-5.60), 4.00 (3.50-4.49), 3.93 (3.12-4.73), and 2.29 (1.56-3.01), respectively.
CONCLUSIONS


PECS I block in patients undergoing breast augmentation surgery does not provide better pain relief than placebo. Therefore, the indications for PECS I block in breast augmentation surgery should be reconsidered.",2020,"In the PACU, three patients had no difference in pain between sides, five had reduced pain on the placebo side, and six had reduced pain on the bupivacaine side.","['patients undergoing breast augmentation surgery', 'women undergoing subpectoral breast augmentation surgery', '14 volunteers were enrolled (power of 90% and alpha<0.05']","['PECS I block', 'bupivacaine', 'placebo']","['pain scores', 'pain relief', 'reduced pain', 'pain', 'pain score', 'Numeric Rating Scale (NRS) pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0191925', 'cui_str': 'Augmentation mammoplasty'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",14.0,0.754972,"In the PACU, three patients had no difference in pain between sides, five had reduced pain on the placebo side, and six had reduced pain on the bupivacaine side.","[{'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Desroches', 'Affiliation': 'Clinique Chirurgicale de Laval, Department of Anesthesiology, Laval, Canada.'}, {'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Department of Anesthesiology, Montreal, Canada. Electronic address: maxim.roy20@gmail.com.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Belliveau', 'Affiliation': 'Hôtel-Dieu de St Jérôme, Department of Anesthesiology, Saint-Jérôme, Canada.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Leblanc', 'Affiliation': 'Clinique Chirurgicale de Laval, Department of Surgery, Laval, Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Beaulieu', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Department of Anesthesiology, Montreal, Canada.""}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.04.013']
2563,32792163,Open transumbilical intussusception reduction in children: A prospective study.,"PURPOSE


Manual intussusception reduction can sometimes be accomplished through the existing umbilical incision after a laparoscopic attempt has failed. We compared the safety and efficacy of open transumbilical intussusception reduction (OTIR) and laparoscopic reduction (LAP).
METHODS


We prospectively enrolled children diagnosed with intussusception at our hospital from June 2014 to December 2018. Clinically stable patients who failed pneumatic intussusception reduction were randomly assigned to the OTIR or LAP group. We compared reduction rates, complications, operative times, and surgery costs between the two groups.
RESULTS


Fifty-one of 451 patients with an intussusception met the study criteria. In the OTIR group (n = 27), 22 intussusceptions were successfully reduced, and 5 required incision extension. The mean operative time was 47.7 ± 10.5 min, and mean surgery cost was 1259.74 ± 46.24 US dollars. In the LAP group (n = 24), 5 patients required conversion to open surgery. Three of the 5 cases were resolved by OTIR, while the other 2 needed incision extension. The mean operative time was 68.63 ± 17.13 min, and mean surgery cost was 1750.63 ± 106.98 US dollars. Severe complications did not occur in either group.
CONCLUSIONS


OTIR was as safe and effective as LAP and had a shorter operative time and lower surgery cost. OTIR is a good option for intussusception reduction in children.
TYPE OF STUDY


Treatment study.
LEVELS OF EVIDENCE


Level I.",2020,Clinically stable patients who failed pneumatic intussusception reduction were randomly assigned to the OTIR or LAP group.,"['Fifty-one of 451 patients with an intussusception met the study criteria', 'We prospectively enrolled children diagnosed with intussusception at our hospital from June 2014 to December 2018', 'Clinically stable patients who failed pneumatic intussusception reduction', 'children']","['open transumbilical intussusception reduction (OTIR) and laparoscopic reduction (LAP', 'OTIR or LAP']","['reduction rates, complications, operative times, and surgery costs', 'mean surgery cost', 'operative time and lower surgery cost', 'safety and efficacy', 'mean operative time', 'Severe complications']","[{'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021933', 'cui_str': 'Intussusception of intestine'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0457793', 'cui_str': 'Transumbilical'}, {'cui': 'C0021933', 'cui_str': 'Intussusception of intestine'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",22.0,0.0182606,Clinically stable patients who failed pneumatic intussusception reduction were randomly assigned to the OTIR or LAP group.,"[{'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Pediatric Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Bao', 'Affiliation': 'Pediatric Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Jiyan', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Pediatric Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Pediatric Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Jiexiong', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Pediatric Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Pediatric Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China. Electronic address: wzhang115@163.com.'}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2020.07.008']
2564,32792245,Comparison of the effects of using non-steroidal anti-inflammatory drugs with or without kinesio taping on the radial nerve in lateral epicondylitis: A randomized-single blind study.,"BACKGROUND


There is no knowledge about the effects of kinesio taping (KT) on the radial nerve in lateral epicondylitis.
OBJECTIVE


This study aimed to determine the effects of non-steroidal-anti-inflammatory drugs (NSAIDs) combined with KT on lateral epicondylitis using ultrasonographic findings.
METHODS


NSAID therapy was administered to the control group for 10 days, and the KT group additionally received KT three times a week for two weeks. Clinical and ultrasonographic evaluations were performed before treatment and at post-treatment at second, sixth and fourteenth weeks. The radial nerve cross sectional area and common extensor tendon thicknesses were measured using ultrasonography.
RESULTS


The study was completed with 40 patients in each group. Improvements in clinical parameters, common extensor tendon thickness, and cross sectional area values were significant in the KT group (p<0.01).
CONCLUSIONS


NSAID plus kinesio taping decrease pain intensity while improving functionality and ultrasonographic parameters, including common extensor tendon thickness and radial nerve cross sectional area; therefore, it may be an option treatment in lateral epicondylitis.",2020,"Improvements in clinical parameters, common extensor tendon thickness, and cross sectional area values were significant in the KT group (p<0.01).
","['lateral epicondylitis', '40 patients in each group']","['kinesio taping (KT', 'non-steroidal-anti-inflammatory drugs (NSAIDs) combined with KT', 'non-steroidal anti-inflammatory drugs with or without kinesio taping', 'NSAID plus kinesio taping']","['pain intensity', 'clinical parameters, common extensor tendon thickness, and cross sectional area values', 'radial nerve cross sectional area and common extensor tendon thicknesses']","[{'cui': 'C0039516', 'cui_str': 'Lateral epicondylitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0224849', 'cui_str': 'Structure of extensor tendon'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0034518', 'cui_str': 'Structure of radial nerve'}]",,0.0618806,"Improvements in clinical parameters, common extensor tendon thickness, and cross sectional area values were significant in the KT group (p<0.01).
","[{'ForeName': 'Basak', 'Initials': 'B', 'LastName': 'Mansiz-Kaplan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital, Ankara, Turkey. Electronic address: basakmansiz@hotmail.com.'}, {'ForeName': 'Secil', 'Initials': 'S', 'LastName': 'Pervane-Vural', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Omer Faruk', 'Initials': 'OF', 'LastName': 'Celik', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Genc', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital, Ankara, Turkey.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2020.07.008']
2565,32792250,"Acceptability of an inactivated influenza vaccine delivered by microneedle patch: Results from a phase I clinical trial of safety, reactogenicity, and immunogenicity.","OBJECTIVE


This study sought to evaluate the acceptability of inactivated influenza vaccine delivered by microneedle patch (MNP) in comparison to inactivated influenza vaccine (IIV) delivered by hypodermic needle.
DESIGN, SETTING, AND PARTICIPANTS


From the general population of Atlanta, Georgia, we screened 112 and enrolled 100 healthy adult subjects ages 18 to 49 years. Main Outcome(s) and Measure(s). Our participants were randomized to 4 groups of 25 per arm: (1) IIV by MNP administered by healthcare worker (HCW), (2) IIV by MNP self-administered by study participants, (3) IIV by intramuscular (IM) injection administered by HCW or (4) placebo by MNP administered by HCW. We administered four questionnaires: at Day 0 before and after study product delivery, and at Days 8 and 28.
RESULTS


At baseline, 98.6% of participants receiving MNP vaccination reported an overall positive experience with MNPs, compared to 86.4% for participants receiving IM vaccination. For future influenza vaccination, study participants (N = 99) preferred MNP (n = 65, 69.9%) to injections or nasal spray (n = 20, 21.5%), and the preference for MNP increased from Day 0 to Day 28. Factor analyses resulted in two scaled measures including MNP Use Perceptions (a = 0.799, n = 5 items) and MNP Perceived Convenience (a = 0.844, n = 4 items) that were included in longitudinal assessments; while findings reflect significant differences across treatment groups on mean scores for ease of use, MNP perceived protection, MNP reliability, and MNP selection knowledge, all groups reported their belief that influenza vaccination by MNP would be reliable and protective, as well as easy-to-use and convenient.
CONCLUSIONS AND RELEVANCE


Most participants were accepting of IIV vaccination by MNP and preferred it to injection. Delivery of IIV by MNP may help increase vaccination coverage.",2020,"Factor analyses resulted in two scaled measures including MNP Use Perceptions (a = 0.799, n = 5 items) and MNP Perceived Convenience (a = 0.844, n = 4 items) that were included in longitudinal assessments; while findings reflect significant differences across treatment groups on mean scores for ease of use, MNP perceived protection, MNP reliability, and MNP selection knowledge, all groups reported their belief that influenza vaccination by MNP would be reliable and protective, as well as easy-to-use and convenient.
","['From the general population of Atlanta, Georgia, we screened 112 and enrolled 100 healthy adult subjects ages 18 to 49\xa0years']","['inactivated influenza vaccine delivered by microneedle patch', 'influenza vaccine (IIV) delivered by hypodermic needle', 'injections or nasal spray', 'MNP administered by healthcare worker (HCW), (2) IIV by MNP self-administered by study participants, (3) IIV by intramuscular (IM) injection administered by HCW or (4) placebo by MNP administered by HCW', 'MNP', 'inactivated influenza vaccine delivered by microneedle patch (MNP']","['mean scores for ease of use, MNP perceived protection, MNP reliability, and MNP selection knowledge', 'overall positive experience with MNPs', 'MNP Use Perceptions', 'safety, reactogenicity, and immunogenicity']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0017452', 'cui_str': 'Georgia state'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0221093', 'cui_str': 'Hypodermic needle'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0282245', 'cui_str': 'Northern Mariana Islands'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",100.0,0.034005,"Factor analyses resulted in two scaled measures including MNP Use Perceptions (a = 0.799, n = 5 items) and MNP Perceived Convenience (a = 0.844, n = 4 items) that were included in longitudinal assessments; while findings reflect significant differences across treatment groups on mean scores for ease of use, MNP perceived protection, MNP reliability, and MNP selection knowledge, all groups reported their belief that influenza vaccination by MNP would be reliable and protective, as well as easy-to-use and convenient.
","[{'ForeName': 'Paula M', 'Initials': 'PM', 'LastName': 'Frew', 'Affiliation': 'The University of Nevada, Las Vegas, School of Public Health (drop and Medicine), United States; UNLV Population Health & Health Equity Initiative, United States. Electronic address: paula.frew@unlv.edu.'}, {'ForeName': 'Michele Bennett', 'Initials': 'MB', 'LastName': 'Paine', 'Affiliation': 'Emory University School of Medicine, Department of Medicine, Division of Infectious Diseases, United States; The Hope Clinic of the Emory Vaccine Center, United States.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Rouphael', 'Affiliation': 'Emory University School of Medicine, Department of Medicine, Division of Infectious Diseases, United States; The Hope Clinic of the Emory Vaccine Center, United States.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Schamel', 'Affiliation': 'Emory University School of Medicine, Department of Medicine, Division of Infectious Diseases, United States.'}, {'ForeName': 'Yunmi', 'Initials': 'Y', 'LastName': 'Chung', 'Affiliation': 'Emory University School of Medicine, Department of Medicine, Division of Infectious Diseases, United States.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Mulligan', 'Affiliation': 'NYU Langone Health, Division of Infectious Diseases and Immunology, United States.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Prausnitz', 'Affiliation': 'Georgia Institute of Technology, School of Chemical and Biomolecular Engineering, United States.'}]",Vaccine,['10.1016/j.vaccine.2020.07.064']
2566,32795282,Acceptability of telephone-based pain coping skills training among African Americans with osteoarthritis enrolled in a randomized controlled trial: a mixed methods analysis.,"BACKGROUND


Osteoarthritis (OA) disproportionately impacts African Americans compared to Caucasians, including greater pain severity. The Pain Coping Skills Training for African Americans with Osteoarthritis (STAART) study examined a culturally enhanced Pain Coping Skills Training (CST) program among African Americans with OA. This mixed methods study evaluated the acceptability of the Pain CST program among STAART participants.
METHODS


STAART was a randomized controlled trial evaluating the effectiveness of an 11-session, telephone-based pain CST program, compared to a usual care control group. Participants were from the University of North Carolina and Durham Veterans Affairs Healthcare Systems. The present analyses included 93 participants in the CST group who completed a questionnaire about experiences with the program. Descriptive statistics of the questionnaire responses were calculated using SAS software. Thematic analysis was applied to open-response data using Dedoose software.
RESULTS


Participants' mean rating of overall helpfulness of the pain CST program for managing arthritis symptoms was 8.0 (SD = 2.2) on a scale of 0-10. A majority of participants reported the program made a positive difference in their experience with arthritis (83.1%). Mean ratings of helpfulness of the specific skills ranged from 7.7 to 8.8 (all scales 0-10). Qualitative analysis of the open-response data identified four prominent themes: Improved Pain Coping, Mood and Emotional Benefits, Improved Physical Functioning, and experiences related to Intervention Delivery.
CONCLUSIONS


The high ratings of helpfulness demonstrate acceptability of this culturally enhanced pain CST program by African Americans with OA. Increasing access to cognitive-behavioral therapy-based programs may be a promising strategy to address racial disparities in OA-related pain and associated outcomes.
TRIAL REGISTRATION


NCT02560922 , registered September 25, 2015.",2020,The Pain Coping Skills Training for African Americans with Osteoarthritis (STAART) study examined a culturally enhanced Pain Coping Skills Training (CST) program among African Americans with OA.,"['African Americans with osteoarthritis enrolled', 'African Americans with OA', 'African Americans with Osteoarthritis (STAART', 'Participants were from the University of North Carolina and Durham Veterans Affairs Healthcare Systems', '93 participants in the CST group who completed a questionnaire about experiences with the program', 'STAART participants']","['11-session, telephone-based pain CST program', 'telephone-based pain coping skills training', 'culturally enhanced Pain Coping Skills Training (CST) program', 'Pain Coping Skills Training']","['Pain Coping, Mood and Emotional Benefits, Improved Physical Functioning, and experiences related to Intervention Delivery', 'mean rating of overall helpfulness of the pain CST program for managing arthritis symptoms', 'Mean ratings of helpfulness of the specific skills']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0454851', 'cui_str': 'Durham'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0729375', 'cui_str': 'Coping skills training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0729375', 'cui_str': 'Coping skills training'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0729375', 'cui_str': 'Coping skills training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",,0.0433981,The Pain Coping Skills Training for African Americans with Osteoarthritis (STAART) study examined a culturally enhanced Pain Coping Skills Training (CST) program among African Americans with OA.,"[{'ForeName': 'Chamara J', 'Initials': 'CJ', 'LastName': 'Dharmasri', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Griesemer', 'Affiliation': 'Department of Health Behavior, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Liubov', 'Initials': 'L', 'LastName': 'Arbeeva', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Lisa C', 'Initials': 'LC', 'LastName': 'Campbell', 'Affiliation': 'Department of Psychology, East Carolina University, Greenville, NC, USA.'}, {'ForeName': 'Crystal W', 'Initials': 'CW', 'LastName': 'Cené', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Keefe', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University, Durham, NC, USA.'}, {'ForeName': 'Eugene Z', 'Initials': 'EZ', 'LastName': 'Oddone', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health System, Durham, NC, USA.'}, {'ForeName': 'Tamara J', 'Initials': 'TJ', 'LastName': 'Somers', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University, Durham, NC, USA.'}, {'ForeName': 'Kelli D', 'Initials': 'KD', 'LastName': 'Allen', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, NC, USA. kdallen@email.unc.edu.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03578-7']
2567,32795283,Rationale and design of the PaTIO study: PhysiotherApeutic Treat-to-target Intervention after Orthopaedic surgery.,"BACKGROUND


Physiotherapy is a proven effective treatment strategy after total knee and hip arthroplasty (TKA/THA), however there is considerable practice variation regarding its timing, content and duration. This study aims to compare the (cost-) effectiveness of a standardized, treat-to-target postoperative physiotherapy strategy with usual postoperative care.
METHODS


Using a cluster randomized study design, consecutive patients scheduled for a primary TKA/THA in 18 hospitals in the Netherlands will be assigned to the treat-to-target physio therapy strategy or usual postoperative care. With the treat-to-target strategy a standardized, individually tailored, exercise program is aimed at the attainment of specific functional milestones. Assessments are done at baseline, 6 weeks and 3, 6, 9 and 12 months follow up. The primary outcome will be the Knee injury / Hip disability and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS / HOOS-PS) at 3 months follow up. Secondary outcomes are the numeric rating scale for pain, the Oxford Knee and Hip Scores, performance-based test and the EuroQol 5D-5L for quality of life. Healthcare use, productivity and satisfaction with postoperative care are measured by means of questionnaires. In total, 624 patients will be needed of which 312 TKA and 312 THA patients.
DISCUSSION


The study will provide evidence concerning the (cost-) effectiveness of the treat-to-target postoperative physiotherapy treatment compared to usual postoperative care. The results of this study will address an important evidence gap and will have a significant impact in daily practice of the physio therapist.
TRIAL REGISTRATION


Registered in the Dutch Trial Registry on April 15, 2018. Registration number: NTR7129 .",2020,"BACKGROUND


Physiotherapy is a proven effective treatment strategy after total knee and hip arthroplasty","['total knee and hip arthroplasty', '624 patients will be needed of which 312 TKA and 312 THA patients', 'consecutive patients scheduled for a primary TKA/THA in 18 hospitals in the Netherlands will be assigned to the treat-to-target physio therapy strategy or usual postoperative care']",[],"['Knee injury / Hip disability and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS / HOOS-PS', 'Healthcare use, productivity and satisfaction with postoperative care', 'numeric rating scale for pain, the Oxford Knee and Hip Scores, performance-based test and the EuroQol 5D-5L for quality of life']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0186193', 'cui_str': 'Repair of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0039245', 'cui_str': 'Tacrine'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032786', 'cui_str': 'Postoperative care'}]",[],"[{'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C2960303', 'cui_str': 'Hip disability and osteoarthritis outcome score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0032786', 'cui_str': 'Postoperative care'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",624.0,0.158489,"BACKGROUND


Physiotherapy is a proven effective treatment strategy after total knee and hip arthroplasty","[{'ForeName': 'Lichelle', 'Initials': 'L', 'LastName': 'Groot', 'Affiliation': 'Department of Orthopedic Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, Netherlands. L.Groot@erasmusmc.nl.'}, {'ForeName': 'Maaike G J', 'Initials': 'MGJ', 'LastName': 'Gademan', 'Affiliation': 'Department of Orthopedic Surgery, LUMC, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Wilfred F', 'Initials': 'WF', 'LastName': 'Peter', 'Affiliation': 'Department of Orthopedic Surgery, LUMC, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Wilbert B', 'Initials': 'WB', 'LastName': 'van den Hout', 'Affiliation': 'Department of Medical Decision Making & Quality of Care, LUMC, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Hennie', 'Initials': 'H', 'LastName': 'Verburg', 'Affiliation': 'Department of Orthopedic Surgery, Reinier de Graaf Hospital, Reinier de Graafweg 5, 2625 AD, Delft, The Netherlands.'}, {'ForeName': 'Thea P M', 'Initials': 'TPM', 'LastName': 'Vliet Vlieland', 'Affiliation': 'Department of Orthopedic Surgery, LUMC, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Reijman', 'Affiliation': 'Department of Orthopedic Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03511-y']
2568,32795284,Ipilimumab plus nivolumab and chemoradiotherapy followed by surgery in patients with resectable and borderline resectable T3-4N0-1 non-small cell lung cancer: the INCREASE trial.,"BACKGROUND


The likelihood of a tumor recurrence in patients with T3-4N0-1 non-small cell lung cancer following multimodality treatment remains substantial, mainly due distant metastases. As pathological complete responses (pCR) in resected specimens are seen in only a minority (28-38%) of patients following chemoradiotherapy, we designed the INCREASE trial (EudraCT-Number: 2019-003454-83; Netherlands Trial Register number: NL8435) to assess if pCR rates could be further improved by adding short course immunotherapy to induction chemoradiotherapy. Translational studies will correlate changes in loco-regional and systemic immune status with patterns of recurrence.
METHODS/DESIGN


This single-arm, prospective phase II trial will enroll 29 patients with either resectable, or borderline resectable, T3-4N0-1 NSCLC. The protocol was approved by the institutional ethics committee. Study enrollment commenced in February 2020. On day 1 of guideline-recommended concurrent chemoradiotherapy (CRT), ipilimumab (IPI, 1 mg/kg IV) and nivolumab (NIVO, 360 mg flat dose IV) will be administered, followed by nivolumab (360 mg flat dose IV) after 3 weeks. Radiotherapy consists of once-daily doses of 2 Gy to a total of 50 Gy, and chemotherapy will consist of a platinum-doublet. An anatomical pulmonary resection is planned 6 weeks after the last day of radiotherapy. The primary study objective is to establish the safety of adding IPI/NIVO to pre-operative CRT, and its impact on pathological tumor response. Secondary objectives are to assess the impact of adding IPI/NIVO to CRT on disease free and overall survival. Exploratory objectives are to characterize tumor inflammation and the immune contexture in the tumor and tumor-draining lymph nodes (TDLN), and to explore the effects of IPI/NIVO and CRT and surgery on distribution and phenotype of peripheral blood immune subsets.
DISCUSSION


The INCREASE trial will evaluate the safety and local efficacy of a combination of 4 modalities in patients with resectable, T3-4N0-1 NSCLC. Translational research will investigate the mechanisms of action and drug related adverse events.
TRIAL REGISTRATION


Netherlands Trial Registration (NTR): NL8435 , Registered 03 March 2020.",2020,"The INCREASE trial will evaluate the safety and local efficacy of a combination of 4 modalities in patients with resectable, T3-4N0-1 NSCLC.","['patients with T3-4N0-1 non-small cell lung cancer', 'patients with resectable, T3-4N0-1 NSCLC', 'patients with resectable and borderline resectable T3-4N0-1 non-small cell lung cancer', '29 patients with either resectable, or borderline resectable, T3-4N0-1 NSCLC']","['guideline-recommended concurrent chemoradiotherapy (CRT), ipilimumab (IPI, 1\u2009mg/kg IV) and nivolumab (NIVO', 'Ipilimumab plus nivolumab and chemoradiotherapy', 'Radiotherapy']","['impact of adding IPI/NIVO to CRT on disease free and overall survival', 'safety and local efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0668760', 'cui_str': 'diinosine pentaphosphate'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0668760', 'cui_str': 'diinosine pentaphosphate'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",29.0,0.329677,"The INCREASE trial will evaluate the safety and local efficacy of a combination of 4 modalities in patients with resectable, T3-4N0-1 NSCLC.","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Dickhoff', 'Affiliation': 'Department of Surgery and Cardiothoracic Surgery, Amsterdam University Medical Center, location VUmc, Cancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands. c.dickhoff@amsterdamumc.nl.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Senan', 'Affiliation': 'Department of Radiation Oncology, Amsterdam University Medical Center, location VUmc, Cancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Famke L', 'Initials': 'FL', 'LastName': 'Schneiders', 'Affiliation': 'Department of Radiation Oncology, Amsterdam University Medical Center, location VUmc, Cancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Veltman', 'Affiliation': 'Department of Pulmonary Diseases, Amsterdam University Medical Center, location VUmcCancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Sayed', 'Initials': 'S', 'LastName': 'Hashemi', 'Affiliation': 'Department of Pulmonary Diseases, Amsterdam University Medical Center, location VUmcCancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes M A', 'Initials': 'JMA', 'LastName': 'Daniels', 'Affiliation': 'Department of Pulmonary Diseases, Amsterdam University Medical Center, location VUmcCancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Fransen', 'Affiliation': 'Department of Pulmonary Diseases, Amsterdam University Medical Center, location VUmcCancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Heineman', 'Affiliation': 'Department of Surgery and Cardiothoracic Surgery, Amsterdam University Medical Center, location VUmc, Cancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Teodora', 'Initials': 'T', 'LastName': 'Radonic', 'Affiliation': 'Department of Pathology, Amsterdam University Medical Center, location VUmc, Cancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam University Medical Center, location VUmc, Cancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Imke H', 'Initials': 'IH', 'LastName': 'Bartelink', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacy, Amsterdam University Medical Center, location VUmc, Cancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Lilian J', 'Initials': 'LJ', 'LastName': 'Meijboom', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Center, location VUmc, Cancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Garcia-Vallejo', 'Affiliation': 'Department of Molecular Cell Biology & Immunology, Amsterdam University Medical Center, location VUmc, Cancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Daniela E', 'Initials': 'DE', 'LastName': 'Oprea-Lager', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Center, location VUmc, Cancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Tanja D', 'Initials': 'TD', 'LastName': 'de Gruijl', 'Affiliation': 'Department of Medical Oncology, Amsterdam University Medical Center, location VUmc, Cancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Idris', 'Initials': 'I', 'LastName': 'Bahce', 'Affiliation': 'Department of Pulmonary Diseases, Amsterdam University Medical Center, location VUmcCancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}]",BMC cancer,['10.1186/s12885-020-07263-9']
2569,32795294,Dietary habits and metabolic response improve in obese children whose mothers received an intervention to promote healthy eating: randomized clinical trial.,"BACKGROUND


Lifestyles habits such as eating unhealthy foodscommence at home and are associated with the development of obesity and comorbidities such as insulin resistance, metabolic syndrome, and chronic degenerative diseases, which are the main causes of death in adults. The present study compared changes in dietary habits, behaviors and metabolic profiles of obese children whose mothers attended at the hospital to group sessions, with those who received the usual nutritional consultation.
METHODS


Randomized clinical trial, 177 mother/obese child pairs participated, 90 in the intervention group and 87 in the control group. The intervention group attended six group education sessions to promote healthy eating, being this an alternative of change of habits in children with obesity. The control group received the usual nutritional consultation; both groups were followed up for 3 months. Frequency of food consumption, behaviors during feeding in the house and metabolic profile was evaluated. Mixed effect linear regression models were used to evaluate the effect of the intervention on the variables of interest, especially in HOMA-IR.
RESULTS


The intervention group reduced the filling of their dishes (p = 0.009), forcing the children to finish meals (p = 0.003) and food substitution (p <  0.001), moreover increased the consumption of roasted foods (p = 0.046), fruits (p = 0.002) and vegetables (p <  0.001). The children in the control group slightly increased HOMA-IR levels (0.51; 95% CI - 0.48 to 1.50), while the children in the intervention group significantly decreased (- 1.22; 95% CI - 2.28 to - 1.16). The difference in HOMA-IR between the control and intervention group at the end of the follow-up was - 1.67; 95% CI: - 3.11 to - 0.24.
CONCLUSIONS


The educational intervention improved some eating habits at home, as well as HOMA-IR levels; why we consider that it can be an extra resource in the management of childhood obesity.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT04374292 (Date assigned: May 5, 2020). Retrospectively registered.",2020,"The children in the control group slightly increased HOMA-IR levels (0.51; 95% CI - 0.48 to 1.50), while the children in the intervention group significantly decreased (- 1.22; 95% CI - 2.28 to - 1.16).","['children with obesity', 'obese children', 'obese children whose mothers attended at the hospital to group sessions, with those who received the usual nutritional consultation', '177 mother/obese child pairs participated, 90 in the intervention group and 87 in the control group']","['intervention group attended six group education sessions to promote healthy eating', 'educational intervention', 'usual nutritional consultation']","['eating habits', 'HOMA-IR', 'Dietary habits and metabolic response', 'HOMA-IR levels', 'consumption of roasted foods', 'filling of their dishes', 'dietary habits, behaviors and metabolic profiles']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0020498', 'cui_str': 'Disseminated idiopathic skeletal hyperostosis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}]",177.0,0.0567629,"The children in the control group slightly increased HOMA-IR levels (0.51; 95% CI - 0.48 to 1.50), while the children in the intervention group significantly decreased (- 1.22; 95% CI - 2.28 to - 1.16).","[{'ForeName': 'Iris Nallely', 'Initials': 'IN', 'LastName': 'López-Contreras', 'Affiliation': 'Gastroenterology and Nutrition Department, Hospital Infantil de México Federico Gómez, Ministry of Health (SSA), Mexico City, Mexico.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Vilchis-Gil', 'Affiliation': 'Epidemiological Research Unit in Endocrinology and Nutrition, Hospital Infantil de México Federico Gomez, Ministry of Health (SSA), Dr. Márquez No 162, 06720, Mexico City, Mexico.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Klünder-Klünder', 'Affiliation': 'Deputy Director of Research, Hospital Infantil de México Federico Gómez, Ministry of Health (SSA), Mexico City, Mexico.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Villalpando-Carrión', 'Affiliation': 'Gastroenterology and Nutrition Department, Hospital Infantil de México Federico Gómez, Ministry of Health (SSA), Mexico City, Mexico.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Flores-Huerta', 'Affiliation': 'Epidemiological Research Unit in Endocrinology and Nutrition, Hospital Infantil de México Federico Gomez, Ministry of Health (SSA), Dr. Márquez No 162, 06720, Mexico City, Mexico. floreshuertamd@gmail.com.'}]",BMC public health,['10.1186/s12889-020-09339-4']
2570,32795739,"Effects of the Lysulin™ supplementation on pre-diabetes: A randomized double-blind, placebo-controlled clinical trial.","BACKGROUND AND AIMS


Diabetes is a leading cause of morbidity and mortality worldwide. Recent studies have demonstrated that nutraceutical products have beneficial effects in diabetes. Present study aims to investigate whether a product (Lysulin™) containing amino acid lysine, micronutrient zinc and vitamin C will have beneficial effects in pre-diabetes.
METHODS


A randomized, double-blind, placebo-controlled trial was conducted for a period of 6 months. The two parallel groups (1:1) were Lysulin™ (Interventional group-IG) and placebo (control group-CG). Evaluations were done at baseline, 1, 3 and 6 months. Primary outcome was defined as change in glycaemic control measured by HbA1c from baseline. Other outcomes included change in; fasting plasma glucose (FPG), 2-h OGTT plasma glucose and lipid profile from baseline. Three multiple regression analyses were performed, where change in FPG, 2-h OGTT, and HbA1c post intervention from baseline respectively were the continuous dependent variable with other independent variables.
RESULTS


One hundred and ten participants were recruited, 50% (n = 55) were males and mean age (±SD) was 46.7 ± 9.9 years. A significantly higher percentage of participants in CG (25.4%, n = 14) developed diabetes in comparison to IG (7.3%, n = 4) (p = 0.018). FPG, 2-h OGTT and HbA1c significantly reduced in the IG only. Both total cholesterol and LDL cholesterol decreased significantly from baseline only in the IG. In all three regression models the best predictor of respective dependent variable was Lysulin™ treatment.
CONCLUSIONS


Lysulin™ improved glycaemic control, with reduced progression to diabetes, in those with pre-diabetes. Treatment also showed a beneficial reduction in total and LDL cholesterol levels.
TRIAL REGISTRATION


Sri Lanka Clinical Trials Registry, identifier: SLCTR/2018/022 (http://slctr.lk/trials/1290). Registered on 13th July 2018; Study protocol version 2.0 (23rd March 2018).",2020,"A significantly higher percentage of participants in CG (25.4%, n = 14) developed diabetes in comparison to IG (7.3%, n = 4) (p = 0.018).","['One hundred and ten participants were recruited, 50% (n\xa0=\xa055) were males and mean age (±SD) was 46.7\xa0±\xa09.9 years']","['Lysulin™', 'Lysulin™ supplementation', 'product (Lysulin™) containing amino acid lysine, micronutrient zinc and vitamin C', 'placebo']","['change in; fasting plasma glucose (FPG), 2-h OGTT plasma glucose and lipid profile', 'FPG, 2-h OGTT and HbA1c', 'change in glycaemic control', 'pre-diabetes', 'total cholesterol and LDL cholesterol', 'total and LDL cholesterol levels', 'glycaemic control']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",110.0,0.642793,"A significantly higher percentage of participants in CG (25.4%, n = 14) developed diabetes in comparison to IG (7.3%, n = 4) (p = 0.018).","[{'ForeName': 'Priyanga', 'Initials': 'P', 'LastName': 'Ranasinghe', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka. Electronic address: priyanga@pharm.cmb.ac.lk.'}, {'ForeName': 'Ranil', 'Initials': 'R', 'LastName': 'Jayawardena', 'Affiliation': 'Department of Physiology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka; Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Queensland, Australia. Electronic address: ranil7@gmail.com.'}, {'ForeName': 'Lal', 'Initials': 'L', 'LastName': 'Chandrasena', 'Affiliation': 'Nawaloka Hospital Research and Education Foundation (NHREF), Nawaloka Hospitals PLC, Colombo, Sri Lanka. Electronic address: dgm@nawaloka.com.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.07.023']
2571,32795835,Is there a role for insulin-like growth factor inhibition in the treatment of COVID-19-related adult respiratory distress syndrome?,"Adult respiratory distress syndrome (ARDS) is the leading cause of death associated with SARS-CoV-2 infection and COVID-19. IGF-1 has been implicated in ARDS, yet its role in relation to COVID-19-related lung injury has not been investigated. We hypothesize that blockage of the IGF-1 receptor (IGF-1R) mitigates lung injury and decreases the risk of death in patients COVID-19-related ARDS. Patients with fibroproliferative ARDS have been shown to have increased IGF-1 and IGF-1R staining in lung tissue specimens. Rising levels of IGF-1 in bronchioalveolar fluid (BAL) and increased IGF-1 mRNA expression in lung tissues (but declining serum IGF-1 levels) have been found in late stage ARDS compared with early lung injury. Blockage of IGF-1R decreases lung tissue damage and increases survival in bleomycin-induced as well as H1N1 influenza-related lung injury in animal models. Teprotumumab is a monoclonal antibody directed against the IGF-1R that was FDA-approved in 2020 for the treatment of Graves' orbitopathy. In order to determine if teprotumumab may reduce lung injury and death related to ARDS in the setting of COVID-19, preliminary clinical data is needed. IGF-1 levels in serum and BAL fluid must be measured in patients with COVID-19-related ARDS. Histopathology from lung samples from patients with COVID-19-related ARDS must be examined for increased expression of the IGF-1R. Once these are ascertained, and if the data support IGF-1 involvement, a randomized, placebo-controlled phase 2A trial of teprotumumab therapy in the setting of COVID-19-related ARDS and non-COVID-19-related ARDS designed to generate initial data on short-term efficacy, safety, dosing and administration should be performed.",2020,Patients with fibroproliferative ARDS have been shown to have increased IGF-1 and IGF-1R staining in lung tissue specimens.,"['COVID-19-related adult respiratory distress syndrome', 'Patients with fibroproliferative ARDS', 'Adult respiratory distress syndrome (ARDS', 'patients with COVID-19-related ARDS']","['placebo', 'IGF-1']","['IGF-1 levels', 'IGF-1 and IGF-1R staining', 'risk of death', 'expression of the IGF-1R']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}]","[{'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0140080', 'cui_str': 'Insulin-Like-Growth Factor I Receptor'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",,0.132459,Patients with fibroproliferative ARDS have been shown to have increased IGF-1 and IGF-1R staining in lung tissue specimens.,"[{'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'Winn', 'Affiliation': 'Department of Ophthalmology, University of California San Francisco, San Francisco, CA, United States; Ophthalmology Section, Surgical Service, San Francisco Veterans Affairs Medical Center, San Francisco, CA, United States. Electronic address: bryan.winn@ucsf.edu.'}]",Medical hypotheses,['10.1016/j.mehy.2020.110167']
2572,32795875,Cost-effectiveness analysis of the 70-gene signature compared with clinical assessment in breast cancer based on a randomised controlled trial.,"BACKGROUND


The clinical utility of the 70-gene signature (MammaPrint®) to guide chemotherapy use in T1-3N0-1M0 breast cancer was demonstrated in the Microarray in Node-Negative and 1 to 3 Positive Lymph Node Disease May Avoid Chemotherapy (MINDACT) study. One thousand four ninety seven of 3356 (46.2%) enrolled patients with high clinical risk (in accordance with the modified Adjuvant! Online clinical-pathological assessment) had a low-risk 70-gene signature. Using patient-level data from the MINDACT trial, the cost-effectiveness of using the 70-gene signature to guide adjuvant chemotherapy selection for clinical high risk, estrogen receptor positive (ER+), human epidermal growth factor 2 negative (HER2-) patients was analysed.
PATIENTS AND METHODS


A hybrid decision tree-Markov model simulated treatment strategies in accordance with the 70-gene signature with clinical assessment versus clinical assessment alone, over a 10-year time horizon. Primary outcomes were quality-adjusted life years (QALYs), country-specific costs and incremental cost-effectiveness ratios (ICERs) for six countries: Belgium, France, Germany, Netherlands, UK and the US.
RESULTS


Treatment strategies guided by the 70-gene signature result in more QALYs compared with clinical assessment alone. Costs of the 70-gene signature strategy were lower in five of six countries. This led to dominance of the 70-gene signature in Belgium, France, Germany, Netherlands and the US and to a cost-effective situation in the UK (ICER £22,910/QALY). Annual national cost savings were €4.2M (Belgium), €24.7M (France), €45.1M (Germany), €12.7M (Netherlands) and $244M (US). UK budget increase was £8.4M.
CONCLUSION


Using the 70-gene signature to safely guide chemotherapy de-escalation in clinical high risk patients with ER+/HER2- tumours is cost-effective compared with using clinical assessment alone. Long-term follow-up and outcomes from the MINDACT trial are necessary to address uncertainties in model inputs.",2020,"Annual national cost savings were €4.2M (Belgium), €24.7M (France), €45.1M (Germany), €12.7M (Netherlands) and $244M (US).",['One thousand four ninety seven of 3356 (46.2%) enrolled patients with high clinical risk (in accordance with the modified Adjuvant'],[],"['quality-adjusted life years (QALYs), country-specific costs and incremental cost-effectiveness ratios (ICERs) for six countries: Belgium, France, Germany, Netherlands, UK and the US', 'Annual national cost savings']","[{'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]",[],"[{'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}]",,0.0661509,"Annual national cost savings were €4.2M (Belgium), €24.7M (France), €45.1M (Germany), €12.7M (Netherlands) and $244M (US).","[{'ForeName': 'Valesca P', 'Initials': 'VP', 'LastName': 'Retèl', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands; Health Technology and Services Research Department, Technical Medical Centre, University of Twente, P.O. Box 217, 7500 AE, Enschede, the Netherlands. Electronic address: v.retel@nki.nl.'}, {'ForeName': 'Danalyn', 'Initials': 'D', 'LastName': 'Byng', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands; Health Technology and Services Research Department, Technical Medical Centre, University of Twente, P.O. Box 217, 7500 AE, Enschede, the Netherlands.'}, {'ForeName': 'Sabine C', 'Initials': 'SC', 'LastName': 'Linn', 'Affiliation': 'Division of Molecular Pathology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands; Department of Medical Oncology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands; Department of Pathology, University Medical Centre, Utrecht University, Huispost STR 6.131, P.O. Box 85500, 3508 GA, Utrecht, the Netherlands.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Jóźwiak', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands; Institute of Biostatistics and Registry Research, Brandenburg Medical School Theodor Fontane, Neuruppin, Germany.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Koffijberg', 'Affiliation': 'Health Technology and Services Research Department, Technical Medical Centre, University of Twente, P.O. Box 217, 7500 AE, Enschede, the Netherlands.'}, {'ForeName': 'Emiel J', 'Initials': 'EJ', 'LastName': 'Rutgers', 'Affiliation': 'Department of Surgery, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Cardoso', 'Affiliation': 'Breast Unit, Champalimaud Clinical Center/Champalimaud Foundation, Lisbon, Portugal, Av. De Brasilia, s/n, 1400-048, Lisbon, Portugal.'}, {'ForeName': 'Martine J', 'Initials': 'MJ', 'LastName': 'Piccart', 'Affiliation': 'Breast Cancer Translational Research Laboratory J.-C. Heuson, Institut Jules Bordet, Université Libre de Bruxelles, 121-125, Boulevard de Waterloo, 1000, Brussels, Belgium.'}, {'ForeName': 'Coralie', 'Initials': 'C', 'LastName': 'Poncet', 'Affiliation': 'European Organisation for Research and Treatment of Cancer, Avenue Emmanuel Mounier, 83/11, 1200, Brussels, Belgium.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': ""Van't Veer"", 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, 2340 Sutter Street, San Francisco, CA, 94115, USA.'}, {'ForeName': 'Wim H', 'Initials': 'WH', 'LastName': 'van Harten', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands; Health Technology and Services Research Department, Technical Medical Centre, University of Twente, P.O. Box 217, 7500 AE, Enschede, the Netherlands.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.07.002']
2573,32795903,Ventilatory support during whole-body row training improves oxygen uptake efficiency in patients with high-level spinal cord injury: A pilot study.,"High-level spinal cord injury (SCI) is characterized by profound respiratory compromise. One consequence is a limitation of whole-body exercise-based rehabilitation, reducing its cardioprotective effect. We investigated the use of ventilatory support during training on cardiorespiratory response to exercise. Nine subjects with high-level SCI (T3-C4) were included in this double-blind sham-controlled study. All had training adaptations plateauing for more than 6 months before enrolling in the study. After performing baseline assessment, participants were randomly assigned to continue training with non-invasive ventilation (NIV: n = 6: IPAP = 20 ± 2, EPAP: 3 cmH 2 O) or sham (n = 3: IPAP = 5, EPAP: 3 cmH 2 O) for 3 months and performed again maximal exercise tests. We compared the oxygen uptake efficiency slope (OUES, the rate of increases in VO 2  in relation to increasing VE) before and after training. Training with NIV increased OUES both compared to baseline (4.1 ± 1.1 vs. 3.4 ± 1.0, i.e. +20 ± 12%, p < 0.05) and Sham (p = 0.01), representing an increase in ability to uptake oxygen for a given ventilation. This result was sustained without NIV during the test, suggesting improved cardiopulmonary reserve. Best responders were the youngest whose characteristics were very similar to sham participants. In addition, NIV tended to increase weekly rowing distance by 24% (p = 0.09, versus 10% in sham). Our results are very suggestive of a positive effect of ventilatory support during whole-body exercise in high-level SCI. Training adaptations found are of great importance since this sub-population of patients have the greatest need for exercise-based cardio-protection.",2020,"In addition, NIV tended to increase weekly rowing distance by 24% (p = 0.09, versus 10% in sham).","['Nine subjects with high-level SCI (T3-C4', 'patients with high-level spinal cord injury']","['continue training with non-invasive ventilation (NIV: n\xa0=\xa06: IPAP\xa0=\xa020\xa0±\xa02, EPAP: 3 cmH 2 O) or sham (n\xa0=\xa03: IPAP\xa0=\xa05, EPAP: 3 cmH 2 O) for 3 months and performed again maximal exercise tests', 'Ventilatory support during whole-body row training']","['oxygen uptake efficiency', 'weekly rowing distance', 'ability to uptake oxygen', 'oxygen uptake efficiency slope (OUES']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]",9.0,0.0857854,"In addition, NIV tended to increase weekly rowing distance by 24% (p = 0.09, versus 10% in sham).","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Vivodtzev', 'Affiliation': 'Harvard Medical School, Department of Physical Medicine and Rehabilitation, Boston, MA, USA; Spaulding Rehabilitation Hospital, Cardiovascular Research Laboratory, Cambridge, MA, USA; Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, 75013, Paris, France. Electronic address: isabelle.vivodtzev@sorbonne.universite.fr.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Napolitano', 'Affiliation': 'Harvard Medical School, Department of Physical Medicine and Rehabilitation, Boston, MA, USA; Spaulding Rehabilitation Hospital, Cardiovascular Research Laboratory, Cambridge, MA, USA.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Picard', 'Affiliation': 'Spaulding Rehabilitation Hospital, Cardiovascular Research Laboratory, Cambridge, MA, USA.'}, {'ForeName': 'J Andrew', 'Initials': 'JA', 'LastName': 'Taylor', 'Affiliation': 'Harvard Medical School, Department of Physical Medicine and Rehabilitation, Boston, MA, USA; Spaulding Rehabilitation Hospital, Cardiovascular Research Laboratory, Cambridge, MA, USA.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106104']
2574,32795989,"Personalized Approach Bias Modification Smartphone App (""SWIPE"") to Reduce Alcohol Use Among People Drinking at Hazardous or Harmful Levels: Protocol for an Open-Label Feasibility Study.","BACKGROUND


Alcohol accounts for 5.1% of the global burden of disease and injury, and approximately 1 in 10 people worldwide develop an alcohol use disorder. Approach bias modification (ABM) is a computerized cognitive training intervention in which patients are trained to ""avoid"" alcohol-related images and ""approach"" neutral or positive images. ABM has been shown to reduce alcohol relapse rates when delivered in residential settings (eg, withdrawal management or rehabilitation). However, many people who drink at hazardous or harmful levels do not require residential treatment or choose not to access it (eg, owing to its cost, duration, inconvenience, or concerns about privacy). Smartphone app-delivered ABM could offer a free, convenient intervention to reduce cravings and consumption that is accessible regardless of time and place, and during periods when support is most needed. Importantly, an ABM app could also easily be personalized (eg, allowing participants to select personally relevant images as training stimuli) and gamified (eg, by rewarding participants for the speed and accuracy of responses) to encourage engagement and training completion.
OBJECTIVE


We aim to test the feasibility and acceptability of ""SWIPE,"" a gamified, personalized alcohol ABM smartphone app, assess its preliminary effectiveness, and explore in which populations the app shows the strongest indicators of effectiveness.
METHODS


We aim to recruit 500 people who drink alcohol at hazardous or harmful levels (Alcohol Use Disorders Identification Test score≥8) and who wish to reduce their drinking. Recruitment will be conducted through social media and websites. The participants' intended alcohol use goal (reduction or abstinence), motivation to change their consumption, and confidence to change their consumption will be measured prior to training. Participants will be instructed to download the SWIPE app and complete at least 2 ABM sessions per week for 4 weeks. Recruitment and completion rates will be used to assess feasibility. Four weeks after downloading SWIPE, participants will be asked to rate SWIPE's functionality, esthetics, and quality to assess acceptability. Alcohol consumption, craving, and dependence will be measured prior to commencing the first session of ABM and 4 weeks later to assess whether these variables change significantly over the course of ABM.
RESULTS


We expect to commence recruitment in August 2020 and complete data collection in March 2021.
CONCLUSIONS


This will be the first study to test the feasibility, acceptability, and preliminary effectiveness of a personalized, gamified ABM intervention smartphone app for hazardous or harmful drinkers. Results will inform further improvements to the app, as well as the design of a statistically powered randomized controlled trial to test its efficacy relative to a control condition. Ultimately, we hope that SWIPE will extend the benefits of ABM to the millions of individuals who consume alcohol at hazardous levels and wish to reduce their use but cannot or choose not to access treatment.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000638932p; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12620000638932p.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/21278.",2020,"ABM has been shown to reduce alcohol relapse rates when delivered in residential settings (eg, withdrawal management or rehabilitation).","['hazardous or harmful drinkers', '500 people who drink alcohol at hazardous or harmful levels (Alcohol Use Disorders Identification Test score≥8) and who wish to reduce their drinking', 'People Drinking at Hazardous or Harmful Levels', 'August 2020 and complete data collection in March 2021']","['ABM', 'ANZCTR', 'computerized cognitive training intervention', 'Smartphone app-delivered ABM']","[""rate SWIPE's functionality, esthetics, and quality to assess acceptability"", 'Alcohol consumption, craving, and dependence', 'alcohol relapse rates']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",,0.0972027,"ABM has been shown to reduce alcohol relapse rates when delivered in residential settings (eg, withdrawal management or rehabilitation).","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Manning', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Richmond, Victoria, Australia.'}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Piercy', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Richmond, Victoria, Australia.'}, {'ForeName': 'Joshua Benjamin Bernard', 'Initials': 'JBB', 'LastName': 'Garfield', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Richmond, Victoria, Australia.'}, {'ForeName': 'Dan Ian', 'Initials': 'DI', 'LastName': 'Lubman', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Richmond, Victoria, Australia.'}]",JMIR research protocols,['10.2196/21278']
2575,32795990,App Technology to Support Physical Activity and Intake of Vitamins and Minerals After Bariatric Surgery (the PromMera Study): Protocol of a Randomized Controlled Clinical Trial.,"BACKGROUND


To optimize postoperative outcomes after bariatric surgery, lifestyle changes including increased physical activity are needed. Micronutrient deficiency after surgery is also common and daily supplementation is recommended.
OBJECTIVE


The aim of the PromMera study is to evaluate the effects of a 12-week smartphone app intervention on promotion of physical activity (primary outcome) and adherence to postsurgery vitamin and mineral supplementation, as well as on other lifestyle factors and overall health in patients undergoing bariatric surgery.
METHODS


The PromMera study is a two-arm, randomized controlled trial comprising patients undergoing bariatric surgery. Participants are randomized postsurgery 1:1 to either the intervention group (ie, use of the PromMera app for 12 weeks) or the control group receiving only standard care. Clinical and lifestyle variables are assessed pre- and postsurgery after 18 weeks (postintervention assessment), 6 months, 1 year, and 2 years. Assessments include body composition using Tanita or BOD POD analyzers, muscle function using handgrip, biomarkers in blood, and an extensive questionnaire on lifestyle factors. Physical activity is objectively measured using the ActiGraph wGT3X-BT triaxial accelerometer.
RESULTS


A total of 154 participants have been enrolled in the study. The last study participant was recruited in May 2019. Data collection will be complete in May 2021.
CONCLUSIONS


Implementing lifestyle changes are crucial after bariatric surgery and new ways to reach patients and support such changes are needed. An app-based intervention is easily delivered at any time and can be a key factor in the adoption of healthier behavioral patterns in this rapidly growing group of patients.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03480464; https://clinicaltrials.gov/ct2/show/NCT03480464.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/19624.",2020,"An app-based intervention is easily delivered at any time and can be a key factor in the adoption of healthier behavioral patterns in this rapidly growing group of patients.
","['patients undergoing bariatric surgery', '154 participants have been enrolled in the study']","['control group receiving only standard care', 'postsurgery vitamin and mineral supplementation', 'Vitamins and Minerals', 'smartphone app intervention']","['Physical activity', 'body composition using Tanita or BOD POD analyzers, muscle function using handgrip, biomarkers in blood, and an extensive questionnaire on lifestyle factors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0556112', 'cui_str': 'Mineral supplement'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]",154.0,0.129942,"An app-based intervention is easily delivered at any time and can be a key factor in the adoption of healthier behavioral patterns in this rapidly growing group of patients.
","[{'ForeName': 'Stephanie Erika', 'Initials': 'SE', 'LastName': 'Bonn', 'Affiliation': 'Clinical Epidemiology Division, Department of Medicine (Solna), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hult', 'Affiliation': 'Clinical Epidemiology Division, Department of Medicine (Solna), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Spetz', 'Affiliation': 'Department of Surgery, Linköping University, Norrköping, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Löf', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Andersson', 'Affiliation': 'Department of Surgery, Linköping University, Norrköping, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Wiren', 'Affiliation': 'Department of Surgery, Ersta Hospital, Stockholm, Sweden.'}, {'ForeName': 'Ylva', 'Initials': 'Y', 'LastName': 'Trolle Lagerros', 'Affiliation': 'Clinical Epidemiology Division, Department of Medicine (Solna), Karolinska Institutet, Stockholm, Sweden.'}]",JMIR research protocols,['10.2196/19624']
2576,32792099,The clinical outcomes of endovenous microwave and laser ablation for varicose veins: A prospective study.,"BACKGROUND


This study investigates the clinical outcomes of endovenous microwave ablation and endovenous laser ablation for varicose veins.
METHODS


A total of 139 patients who underwent endovenous microwave ablation and 145 patients who underwent endovenous laser ablation were included in this multicenter study. The clinical outcomes and complications were assessed at 1, 6, and 12 months after the procedure. The effect on quality of life was assessed by the Aberdeen Varicose Vein Questionnaire and the EuroQol Group 5-Dimension Self-Report Questionnaire.
RESULTS


The endovenous microwave ablation group had a shorter procedure time than the endovenous laser ablation group (42.58 ± 15.62 minutes vs 65.46 ± 24.38 minutes, P < .01), and no significant differences were observed in the other procedure parameters. The incidences of induration (20.26% vs 31.06%) and ecchymosis (13.07% vs 22.98%, P < .05) were lower in the endovenous microwave ablation group. The rates of temporary paresthesia (9.80% vs 18.01%) and residual varicosities (8.61% vs 16.77%, P < .05) were lower in the endovenous microwave ablation group at 1 month. There were no significant differences in paresthesia or saphenous vein closure rates between the groups at 6 and 12 months. Both groups had significant improvements in their Aberdeen Varicose Vein Questionnaire and EuroQol Group 5-Dimension Self-Report Questionnaire scores post-procedure, and no significant differences in Aberdeen Varicose Vein Questionnaire and EuroQol Group 5-Dimension Self-Report Questionnaire scores were confirmed. However, local recurrence below the knee was lower in the endovenous microwave ablation group (2.34% vs 8.46%, P < .05) after 12 months.
CONCLUSION


Our results confirmed that the endovenous microwave ablation procedure demonstrated a shorter procedure time, lower complication, and local recurrence than the endovenous laser ablation procedure.",2020,There were no significant differences in paresthesia or saphenous vein closure rates between the groups at 6 and 12 months.,"['and 145 patients who underwent', '139 patients who underwent', 'varicose veins']","['endovenous microwave ablation', 'endovenous microwave and laser ablation', 'endovenous laser ablation', 'endovenous microwave ablation and endovenous laser ablation']","['quality of life', 'local recurrence below the knee', 'incidences of induration', 'shorter procedure time, lower complication, and local recurrence', 'rates of temporary paresthesia', 'shorter procedure time', 'residual varicosities', 'paresthesia or saphenous vein closure rates', 'Aberdeen Varicose Vein Questionnaire and EuroQol Group 5-Dimension Self-Report Questionnaire scores', 'ecchymosis']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0042345', 'cui_str': 'Phlebectasia'}]","[{'cui': 'C3854551', 'cui_str': 'Microwave ablation'}, {'cui': 'C0026051', 'cui_str': 'Microwave'}, {'cui': 'C0348007', 'cui_str': 'Laser Ablation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332534', 'cui_str': 'Induration'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0042345', 'cui_str': 'Phlebectasia'}, {'cui': 'C0036186', 'cui_str': 'Saphenous vein structure'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}]",139.0,0.017454,There were no significant differences in paresthesia or saphenous vein closure rates between the groups at 6 and 12 months.,"[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Department of Vascular Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. Electronic address: jdvascs@163.com.""}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Integrated TCM-WM Surgery, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Zhiqing', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': 'Department of General Surgery, the Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Chenghua', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': ""Department of Ultrasound Medicine, Nanjing Lishui People's Hospital, Nanjing, China.""}, {'ForeName': 'Jianlin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Vascular Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': ""Department of Vascular Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}]",Surgery,['10.1016/j.surg.2020.06.035']
2577,32792107,A Tailored Cognitive-Behavioural Intervention Produces Comparable Reductions in Regimen-Related Distress in Adults With Type 2 Diabetes Regardless of Insulin Use: 12-Month Outcomes From the COMRADE Trial.,"OBJECTIVES


Our aim in this study was to determine whether a cognitive-behavioural therapy plus small changes lifestyle intervention can produce comparable improvements in insulin users vs patients not using insulin with uncontrolled type 2 diabetes (T2D) and comorbid depressive or regimen-related distress (RRD) symptoms.
METHODS


This study is a secondary analysis of Collaborative Care Management for Distress and Depression in Rural Diabetes Study, a randomized, controlled trial of a 16-session, severity-tailored cognitive-behavioural therapy plus small changes lifestyle intervention compared with usual care. Outcomes included glycated hemoglobin (A1C), regimen-related distress, depression, medication adherence and diabetes self-care. Our investigation provides 2 sets of contrasts: 1) insulin users in the intervention group compared with insulin users in the usual-care group and 2) insulin users compared with noninsulin users in the intervention group only.
RESULTS


Of the 139 participants, 72 (52%) were using insulin at baseline and had significantly higher levels of A1C (10.2±2.1% vs 8.9±1.6%) and RRD (3.3±1.4 vs 2.8±1.1), and significantly poorer medication adherence (5.2±2.1 days/wk vs 5.5±1.7 days/wk). Intervention patients using insulin exhibited significantly greater reductions in RRD and marginally significant improvements in medication adherence and A1C compared with insulin users in usual care. Within the intervention group, changes in RRD, medication adherence and A1C did not differ significantly by insulin use.
CONCLUSIONS


Tailored cognitive-behavioural therapy with a small-changes lifestyle intervention improved elevated RRD and A1C outcomes at least as effectively in insulin users as non‒insulin users. Future powered studies need to address the role of insulin use in uptake and treatment outcomes.",2020,"Within the intervention group, changes in RRD, medication adherence and A1C did not differ significantly by insulin use.
","['Distress and Depression in Rural Diabetes Study', 'Adults With Type 2 Diabetes', 'insulin users vs patients not using insulin with uncontrolled type 2 diabetes (T2D) and comorbid depressive or regimen-related distress (RRD) symptoms']","['Cognitive-Behavioural Intervention', '16-session, severity-tailored cognitive-behavioural therapy plus small changes lifestyle intervention', 'Insulin Use', 'cognitive-behavioural therapy plus small changes lifestyle intervention', 'Collaborative Care Management']","['glycated hemoglobin (A1C), regimen-related distress, depression, medication adherence and diabetes self-care', 'medication adherence and A1C', 'changes in RRD, medication adherence and A1C', 'elevated RRD and A1C outcomes', 'levels of A1C', 'RRD', 'medication adherence']","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445107', 'cui_str': 'Not used'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0240016', 'cui_str': 'Insulin used'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",139.0,0.123111,"Within the intervention group, changes in RRD, medication adherence and A1C did not differ significantly by insulin use.
","[{'ForeName': 'Lesley D', 'Initials': 'LD', 'LastName': 'Lutes', 'Affiliation': 'Psychology Department, University of British Columbia, Kelowna, British Columbia, Canada. Electronic address: lesley.lutes@ubc.ca.'}, {'ForeName': 'Doyle M', 'Initials': 'DM', 'LastName': 'Cummings', 'Affiliation': 'Department of Family Medicine, Brody School of Medicine, East Carolina University, Greenville, North Carolina, United States; Center for Health Disparities, East Carolina University, Greenville, North Carolina, United States.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Littlewood', 'Affiliation': 'School of Social Work, University of South Florida, Tampa, Florida, United States.'}, {'ForeName': 'Marina T', 'Initials': 'MT', 'LastName': 'Le', 'Affiliation': 'Psychology Department, University of British Columbia, Kelowna, British Columbia, Canada.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Kirian', 'Affiliation': 'Department of Family Medicine, Brody School of Medicine, East Carolina University, Greenville, North Carolina, United States.'}, {'ForeName': 'Shivajirao', 'Initials': 'S', 'LastName': 'Patil', 'Affiliation': 'Department of Family Medicine, Brody School of Medicine, East Carolina University, Greenville, North Carolina, United States.'}, {'ForeName': 'Chelsey', 'Initials': 'C', 'LastName': 'Solar', 'Affiliation': 'Department of Psychology, East Carolina University, Greenville, North Carolina, United States.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Carraway', 'Affiliation': 'Department of Family Medicine, Brody School of Medicine, East Carolina University, Greenville, North Carolina, United States.'}, {'ForeName': 'Bertha', 'Initials': 'B', 'LastName': 'Hambidge', 'Affiliation': 'Department of Family Medicine, Brody School of Medicine, East Carolina University, Greenville, North Carolina, United States.'}]",Canadian journal of diabetes,['10.1016/j.jcjd.2020.05.016']
2578,32792358,Tumor copy-number alterations predict response to immune-checkpoint-blockade in gastrointestinal cancer.,"BACKGROUND


Despite the great achievements made in immune-checkpoint-blockade (ICB) in cancer therapy, there are no effective predictive biomarkers in gastrointestinal (GI) cancer.
METHODS


This study included 93 metastatic GI patients treated with ICBs. The first cohort comprising 73 GI cancer patients were randomly assigned into discovery (n=44) and validation (n=29) cohorts. Comprehensive genomic profiling was performed on all samples to determine tumor mutational burden (TMB) and copy-number alterations (CNAs). A subset of samples was collected for RNA immune oncology (IO) panel sequencing, microsatellite instability (MSI)/mismatch repair and program death ligand 1 (PD-L1) expression evaluation. In addition, 20 gastric cancer (GC) patients were recruited as the second validation cohort.
RESULTS


In the first cohort of 73 GI cancer patients, a lower burden of CNA was observed in patients with durable clinical benefit (DCB). In both the discovery (n=44) and validation (n=29) subsets, lower burden of CNA was associated with an improved clinical benefit and better overall survival (OS). Efficacy also correlated with a higher TMB. Of note, a combinatorial biomarker of TMB and CNA may better stratify DCB patients from ICB treatment, which was further confirmed in the second validation cohort of 20 GC patients. Finally, patients with lower burden of CNA revealed increased immune signatures in our cohort and The Cancer Genome Atlas data sets as well.
CONCLUSIONS


Our results suggest that the burden of CNA may have superior predictive value compared with other signatures, including PD-L1, MSI and TMB. The joint biomarker of CNA burden and TMB may better stratify DCB patients, thereby providing a rational choice for GI patients treated with ICBs.",2020,Efficacy also correlated with a higher TMB.,"['20 gastric cancer (GC) patients were recruited as the second validation cohort', '93 metastatic GI patients treated with', '73\u2009GI cancer patients', 'gastrointestinal cancer']",['ICBs'],"['Efficacy', 'clinical benefit and better overall survival (OS', 'tumor mutational burden (TMB) and copy-number alterations (CNAs', 'burden of CNA']","[{'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}]",[],"[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1511518', 'cui_str': 'Copy Number Polymorphisms'}]",93.0,0.124652,Efficacy also correlated with a higher TMB.,"[{'ForeName': 'Zhihao', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Genecast Precision Medicine Technology Institute, Beijing, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Jifang', 'Initials': 'J', 'LastName': 'Gong', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Jianling', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Genecast Precision Medicine Technology Institute, Beijing, China.'}, {'ForeName': 'Jianing', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Genecast Precision Medicine Technology Institute, Beijing, China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': 'Genecast Precision Medicine Technology Institute, Beijing, China.'}, {'ForeName': 'Huaibo', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Genecast Precision Medicine Technology Institute, Beijing, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Jiao', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Xiaotian', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Peng', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Zhenghang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Henghui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Institute of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, China shenlin@bjmu.edu.cn zhhbao@ccmu.edu.cn.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China shenlin@bjmu.edu.cn zhhbao@ccmu.edu.cn.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2019-000374']
2579,32792359,Prediction of immune checkpoint inhibition with immune oncology-related gene expression in gastrointestinal cancer using a machine learning classifier.,"Immune checkpoint inhibitors (ICIs) have revolutionized the therapeutic landscape of gastrointestinal cancer. However, biomarkers correlated with the efficacy of ICIs in gastrointestinal cancer are still lacking. In this study, we performed 395-plex immune oncology (IO)-related gene target sequencing in tumor samples from 96 patients with metastatic gastrointestinal cancer patients treated with ICIs, and a linear support vector machine learning strategy was applied to construct a predictive model. ResultsAll 96 patients were randomly assigned into the discovery (n=72) and validation (n=24) cohorts. A 24-gene RNA signature (termed the IO-score) was constructed from 395 immune-related gene expression profiling using a machine learning strategy to identify patients who might benefit from ICIs. The durable clinical benefit rate was higher in patients with a high IO-score than in patients with a low IO-score (discovery cohort: 92.0% vs 4.3%, p<0.001; validation cohort: 85.7% vs 17.6%, p=0.004). The IO-score may exhibit a higher predictive value in the discovery (area under the receiver operating characteristic curve (AUC)=0.97)) and validation (AUC=0.74) cohorts compared with the programmed death ligand 1 positivity (AUC=0.52), tumor mutational burden (AUC=0.69) and microsatellite instability status (AUC=0.59) in the combined cohort. Moreover, patients with a high IO-score also exhibited a prolonged overall survival compared with patients with a low IO-score (discovery cohort: HR, 0.29; 95% CI 0.15 to 0.56; p=0.003; validation cohort: HR, 0.32; 95% CI 0.10 to 1.05; p=0.04). Taken together, our results indicated the potential of IO-score as a biomarker for immunotherapy in patients with gastrointestinal cancers.",2020,The durable clinical benefit rate was higher in patients with a high IO-score than in patients with a low IO-score (discovery cohort:,"['96 patients with metastatic gastrointestinal cancer patients treated with', 'ResultsAll 96 patients were randomly assigned into the discovery (n=72) and validation (n=24) cohorts', 'patients with gastrointestinal cancers', 'patients with a high IO-score than in patients with a low IO-score (discovery cohort']","['395-plex immune oncology (IO)-related gene target sequencing', 'Immune checkpoint inhibitors (ICIs', 'ICIs, and a linear support vector machine learning strategy']","['durable clinical benefit rate', 'potential of IO-score', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0242613', 'cui_str': 'Gene Targeting'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C2699740', 'cui_str': 'Support Vector Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",96.0,0.0635341,The durable clinical benefit rate was higher in patients with a high IO-score than in patients with a low IO-score (discovery cohort:,"[{'ForeName': 'Zhihao', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Genecast Precision Medicine Technology Institute, Beijing, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Jiao', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Genecast Precision Medicine Technology Institute, Beijing, China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': 'Genecast Precision Medicine Technology Institute, Beijing, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Jifang', 'Initials': 'J', 'LastName': 'Gong', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Xiaotian', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Xicheng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Peng', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Changsong', 'Initials': 'C', 'LastName': 'Qi', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Zhenghang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Brock', 'Affiliation': 'Department of Surgery, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Henghui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Institute of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, China shenlin@bjmu.edu.cn zhhbao@ccmu.edu.cn.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China shenlin@bjmu.edu.cn zhhbao@ccmu.edu.cn.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2020-000631']
2580,32792403,Building social cohesion between Christians and Muslims through soccer in post-ISIS Iraq.,"Can intergroup contact build social cohesion after war? I randomly assigned Iraqi Christians displaced by the Islamic State of Iraq and Syria (ISIS) to an all-Christian soccer team or to a team mixed with Muslims. The intervention improved behaviors toward Muslim peers: Christians with Muslim teammates were more likely to vote for a Muslim (not on their team) to receive a sportsmanship award, register for a mixed team next season, and train with Muslims 6 months after the intervention. The intervention did not substantially affect behaviors in other social contexts, such as patronizing a restaurant in Muslim-dominated Mosul or attending a mixed social event, nor did it yield consistent effects on intergroup attitudes. Although contact can build tolerant behaviors toward peers within an intervention, building broader social cohesion outside of it is more challenging.",2020,"The intervention improved behaviors toward Muslim peers: Christians with Muslim teammates were more likely to vote for a Muslim (not on their team) to receive a sportsmanship award, register for a mixed team next season, and train with Muslims 6 months after the intervention.",[],['Iraqi Christians displaced by the Islamic State of Iraq and Syria (ISIS) to an all-Christian soccer team or to a team mixed with Muslims'],[],[],"[{'cui': 'C1556087', 'cui_str': 'Iraqi'}, {'cui': 'C0008532', 'cui_str': 'Christian religion'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0022126', 'cui_str': 'Islam'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0022066', 'cui_str': 'Iraq'}, {'cui': 'C0039138', 'cui_str': 'Syria'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}]",[],,0.027518,"The intervention improved behaviors toward Muslim peers: Christians with Muslim teammates were more likely to vote for a Muslim (not on their team) to receive a sportsmanship award, register for a mixed team next season, and train with Muslims 6 months after the intervention.","[{'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Mousa', 'Affiliation': 'Stanford University, Palo Alto, CA 94305, USA.'}]","Science (New York, N.Y.)",['10.1126/science.abb3153']
2581,32792418,"Pain, physical symptoms and functional assessment in progressive neurological disease in palliative care.","OBJECTIVES


The aim of the research was to identify the most frequent symptoms of patients with progressive neurological disease (PND) in relation to their functional state. Another objective was to determine the effects of consultations with a multidisciplinary palliative team on mitigating the symptoms burden, subjective evaluation of health, disease progression and improvement of the functional state.
METHODS


The interventional control study included 151 patients with PND (98 patients in the intervention group, 53 patients in the control group). The intervention group was provided with consultations of a multidisciplinary palliative team. The symptoms scale of the progressive neurological diseases quality of life was used to collect data. The patients completed the questionnaire before the provided intervention and 3 months after that.
RESULTS


Pain and fatigue were identified as the symptoms that trouble the patients the most. After the intervention, there was a determined statistically significant improvement in the evaluation of 9 out of 11 symptoms (except excretion and urination) among the patients from the intervention group compared with the control group. When assessed again, the patients from the intervention group showed an improvement with respect to six symptoms (pain, fatigue, tremor, stiffness, cramps, excretion), while the patients from the control group had six symptoms that deteriorated (drowsiness, dyspnoea, stiffness, swallowing, salivation, excretion). There was not any confirmed positive impact of the intervention on the cognitive functions of the patients.
CONCLUSION


The provision of consultations with the multidisciplinary palliative team to patients with PND in an advanced stage of disease resulted in decreasing their symptoms burden and improving their functional state.",2020,"When assessed again, the patients from the intervention group showed an improvement with respect to six symptoms (pain, fatigue, tremor, stiffness, cramps, excretion), while the patients from the control group had six symptoms that deteriorated (drowsiness, dyspnoea, stiffness, swallowing, salivation, excretion).","['151 patients with PND (98 patients in the intervention group, 53 patients in the control group', 'patients with progressive neurological disease (PND', 'progressive neurological disease in palliative care']",[],"['Pain and fatigue', 'evaluation of 9 out of 11 symptoms (except excretion and urination', 'six symptoms (pain, fatigue, tremor, stiffness, cramps, excretion', 'Pain, physical symptoms and functional assessment', 'cognitive functions', 'six symptoms that deteriorated (drowsiness, dyspnoea, stiffness, swallowing, salivation, excretion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0036104', 'cui_str': 'Salivary secretion'}]",151.0,0.0272345,"When assessed again, the patients from the intervention group showed an improvement with respect to six symptoms (pain, fatigue, tremor, stiffness, cramps, excretion), while the patients from the control group had six symptoms that deteriorated (drowsiness, dyspnoea, stiffness, swallowing, salivation, excretion).","[{'ForeName': 'Radka', 'Initials': 'R', 'LastName': 'Bužgová', 'Affiliation': 'Department of Nursing and Midwifery, Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic radka.buzgova@osu.cz.'}, {'ForeName': 'Radka', 'Initials': 'R', 'LastName': 'Kozáková', 'Affiliation': 'Department of Nursing and Midwifery, Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Bar', 'Affiliation': 'Neurology Clinic, University Hospital Ostrava, Ostrava, Czech Republic.'}]",BMJ supportive & palliative care,['10.1136/bmjspcare-2020-002416']
2582,32792420,Resistance training in advanced cancer: a phase II safety and feasibility trial-home versus hospital.,"BACKGROUND


Resistance training (RT) is an effective way to increase muscle mass but little is known about its role to prevent sarcopenia in advanced cancer. Furthermore, the preferred setting for this training is not known. Considering home is frequently the place of care and death preferred by cancer patients, it is important to find out whether this would also be the best training setting as opposed to the most common one, hospital.
OBJECTIVES


We aimed to test if RT at home and in hospital is feasible (primary outcome) and safe in advanced cancer, with a view to inform a phase III trial.
METHODS


Phase II randomised controlled trial including adults (≥18 years) with incurable solid tumours, randomised into one of three arms: (1) supervised RT at home; (2) supervised RT in hospital; (3) standard care with information leaflet. Both training programmes were similar, ran one-to-one with therapists and planned to last 12 weeks (three sessions/week). Feasibility included adherence (proportion of completed sessions) and acceptability (proportion of completed exercises), compared using Fisher's test.
RESULTS


We included 15 patients (53% men, median age 68), 5 per arm. The home intervention had higher adherence (49% vs 9% in hospital; p<0.001). Acceptability was similar (93% in home and 95% in hospital; p=0.179). No adverse events were recorded.
CONCLUSIONS


RT is a safe intervention, more feasible at home than in hospital in advanced cancer. Ways to increase adherence to the home intervention could further improve its potential benefit.
TRIAL REGISTRATION NUMBER


NCT02930876.",2020,The home intervention had higher adherence (49% vs 9% in hospital; p<0.001).,"['15 patients (53% men, median age 68), 5 per arm', 'adults (≥18 years) with incurable solid tumours', 'advanced cancer']","['Resistance training', 'supervised RT at home; (2) supervised RT in hospital; (3) standard care with information leaflet', 'Resistance training (RT']","['adverse events', 'Acceptability', 'higher adherence', 'adherence (proportion of completed sessions) and acceptability (proportion of completed exercises']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",15.0,0.0656388,The home intervention had higher adherence (49% vs 9% in hospital; p<0.001).,"[{'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Ribeiro', 'Affiliation': ""Cicely Saunders Institute of Palliative Care and Rehabilitation, King's College London, London, UK catarinaribeiroa@gmail.com.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Santos', 'Affiliation': 'Medicina Fisica e de Reabilitação, Centro Hospitalar de Lisboa Central EPE, Lisbon, Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Correia', 'Affiliation': 'Exercise Physiology, The Strength Clinic, Lisbon, Portugal.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Maddocks', 'Affiliation': ""Cicely Saunders Institute of Palliative Care and Rehabilitation, King's College London, London, UK.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Gomes', 'Affiliation': ""Cicely Saunders Institute of Palliative Care and Rehabilitation, King's College London, London, UK.""}]",BMJ supportive & palliative care,['10.1136/bmjspcare-2020-002230']
2583,32792711,A randomised study comparing the extent of block produced by spinal column height and body weight-based formulae for paediatric caudal analgesia.,"Background and Aims


Height and weight-based formulae are used for calculation of dose of medications for caudal analgesia but these have not been compared. We compared spinal column height-based Spiegel and weight-based Takasaki and Armitage formulae for achieving maximum height of sensory neuraxial block after caudal epidural analgesia in paediatric patients.
Methods


In this double-blind randomised study, children aged between 1 and 6 years and planned for infra-umbilical surgery were randomly allocated to receive caudal epidural block (targeting T 10 level block) with 0.25% bupivacaine, using a volume calculated by modified Spiegel formula (group I), Takasaki formula (group II), and Armitage formula (group III). The Institute ethics committee reviewed and approved the study protocol. The primary endpoint of the study was the difference in the number of spinal segments blocked as assessed by pinprick method. The secondary endpoint was the difference in volume of 0.25% bupivacaine used among the groups. The groups were compared using one-way ANOVA.
Results


Seventy-five patients (25 in each group) completed the study as per protocol. The mean number of spinal segments blocked was significantly different among groups ( P  < 0.001) with patients in group I (13.8 ± 0.83) showing significantly lower number of spinal segments blocked as compared to that in group II (15.8 ± 1.06;  P  < 0.001), and group III (16.8 ± 1.28;  P  < 0.001). The mean volume of 0.25% bupivacaine used in group I was significantly lower ( P  < 0.001) than that in group II and group III.
Conclusion


Dose calculation in caudal epidural analgesia as per spinal column height-based modified Spiegel formula was more precise than bodyweight-based Takasaki and Armitage formulae.",2020,"The mean volume of 0.25% bupivacaine used in group I was significantly lower ( P  < 0.001) than that in group II and group III.
","['paediatric patients', 'children aged between 1 and 6 years and planned for infra-umbilical surgery']","['caudal epidural block (targeting T 10 level block) with 0.25% bupivacaine, using a volume calculated by modified Spiegel formula (group I), Takasaki formula', 'spinal column height-based Spiegel and weight-based Takasaki and Armitage formulae', 'bupivacaine']","['mean volume', 'mean number of spinal segments blocked', 'number of spinal segments', 'number of spinal segments blocked as assessed by pinprick method']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0394837', 'cui_str': 'Local anesthetic sacral epidural block'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",75.0,0.0502598,"The mean volume of 0.25% bupivacaine used in group I was significantly lower ( P  < 0.001) than that in group II and group III.
","[{'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Kaushal', 'Affiliation': 'Department of Anaesthesiology, Indira Gandhi Medical College, Shimla, Himachal Pradesh, India.'}, {'ForeName': 'Surinder', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Anaesthesiology, Indira Gandhi Medical College, Shimla, Himachal Pradesh, India.'}, {'ForeName': 'Anupam', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Department of Anaesthesiology, Indira Gandhi Medical College, Shimla, Himachal Pradesh, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_824_19']
2584,32792712,Multipoint transcutaneous electrical stimulation reduces median effective plasma concentration of propofol: A randomised clinical trial.,"Background and Aims


Previous work shows that transcutaneous electrical stimulation (TES) has analgesic and sedative effects. However, it is unclear whether TES can affect the sedative effect of propofol or not. This study was designed to assess the effect of TES on median effective plasma concentration (Cp50) of propofol and haemodynamic changes before and after tracheal intubation.
Methods


48 patients belonging to ASA I or II posted for thyroidectomy were randomly allocated into control and TES groups. Up-and-down method was used to determine Cp50 of propofol. The average concentration of propofol in each crossover was calculated and the average concentration of those six values was defined as Cp50 of propofol.
Results


Cp50 of propofol was 3.70 ± 0.28 μg/mL and 3.08 ± 0.31 μg/mL in control and TES groups, respectively ( P  < 0.05). There were no significant differences in MAP (90.3 ± 12.4 mmHg vs. 97.0 ± 10.8 mmHg, 94.2 ± 18.7 mmHg vs. 98.3 ± 16.6 mmHg and 84.9 ± 14.1 mmHg vs. 91.6 ± 16.2 mmHg) and HR (78.2 ± 11.3 b/min vs. 75.6 ± 9.5 b/min, 90.9 ± 15.4 b/min vs. 90.4 ± 14.9 b/min and 86.7 ± 13.7 b/min vs. 84.0 ± 15.9 b/min) at T0, T1 and T2 between two groups. In TES group, HR changes at T1 and T2 were significantly higher than those at T0.
Conclusion


TES can make an assistant effect on sedation and decrease Cp50 of propofol. But the haemodynamic fluctuations in TES group, especially the HR changes, seem to be more obvious than those in control group.",2020,"There were no significant differences in MAP (90.3 ± 12.4 mmHg vs. 97.0 ± 10.8 mmHg, 94.2 ± 18.7 mmHg vs. 98.3 ± 16.6 mmHg and 84.9 ± 14.1 mmHg vs. 91.6 ± 16.2 mmHg) and HR (78.2 ± 11.3 b/min vs. 75.6 ± 9.5 b/min, 90.9 ± 15.4 b/min vs. 90.4 ± 14.9 b/min and 86.7 ± 13.7 b/min vs. 84.0 ± 15.9 b/min) at T0, T1 and T2 between two groups.",['48 patients belonging to ASA I or II posted for thyroidectomy'],"['TES', 'propofol', 'transcutaneous electrical stimulation (TES', 'Multipoint transcutaneous electrical stimulation']","['sedative effect', 'HR changes', 'median effective plasma concentration (Cp50', 'average concentration of propofol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C3179159', 'cui_str': 'Sedative Effects'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]",48.0,0.022465,"There were no significant differences in MAP (90.3 ± 12.4 mmHg vs. 97.0 ± 10.8 mmHg, 94.2 ± 18.7 mmHg vs. 98.3 ± 16.6 mmHg and 84.9 ± 14.1 mmHg vs. 91.6 ± 16.2 mmHg) and HR (78.2 ± 11.3 b/min vs. 75.6 ± 9.5 b/min, 90.9 ± 15.4 b/min vs. 90.4 ± 14.9 b/min and 86.7 ± 13.7 b/min vs. 84.0 ± 15.9 b/min) at T0, T1 and T2 between two groups.","[{'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Jing', 'Affiliation': ""Department of Anaesthesiology, Peking University People's Hospital (Beijing Cancer Hospital), Beijing, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Ling', 'Affiliation': ""Department of Anaesthesiology, Peking University People's Hospital (Beijing Cancer Hospital), Beijing, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Yi', 'Affiliation': ""Department of Anaesthesiology, Peking University People's Hospital (Beijing Cancer Hospital), Beijing, China.""}]",Indian journal of anaesthesia,['10.4103/ija.IJA_775_19']
2585,32792716,Comparison of transversus abdominis plane block and intrathecal morphine for laparoscopic donor nephrectomy: Randomised controlled trial.,"Background and Aims


Postoperative pain following laparoscopic donor nephrectomy (LDN) is significant and no suitable analgesic technique is described. Opioid analgesia in standard doses is often suboptimal and associated with numerous adverse effects. Transversus abdominis plane (TAP) block has been evaluated in various laparoscopic procedures. Intrathecal morphine (ITM) has been seen to provide long-lasting analgesia of superior quality in laparoscopic colorectal procedures.
Methods


The present study was undertaken to evaluate the analgesic efficacy of single-dose ITM 5 μg/kg for LDN. After ethics approval, 60 adult patients scheduled for LDN were randomised to receive intravenous fentanyl, ultrasound-guided TAP block or ITM for postoperative analgesia. Postoperative 24-h patient-controlled analgesia (PCA) fentanyl consumption, visual analogue scale (VAS) score and intraoperative fentanyl and muscle relaxant requirements were compared. Statistical analysis was performed using appropriate statistical tests by using Stata 11.1 software.
Results


Haemodynamic stability at pneumoperitoneum and in the post anaesthesia care unit was significantly better in patients receiving ITM. Intraoperative rescue fentanyl requirement ( P  = 0.01) and postoperative fentanyl requirement until 24 h ( P  = 0.000) were significantly lower in the morphine group. Postoperative VAS at rest and on movement was significantly lower in the morphine group at all points of assessment ( P  = 0.000).
Conclusion


ITM 5 μg/kg provides better intraoperative and postoperative analgesia and reduces postoperative PCA fentanyl requirement in laparoscopic donor nephrectomy compared to TAP block or intravenous fentanyl.",2020,"Postoperative VAS at rest and on movement was significantly lower in the morphine group at all points of assessment ( P  = 0.000).
","['laparoscopic donor nephrectomy', '60 adult patients scheduled for LDN']","['Opioid analgesia', 'laparoscopic donor nephrectomy', 'Intrathecal morphine (ITM', 'Transversus abdominis plane (TAP) block', 'TAP block or intravenous fentanyl', 'laparoscopic donor nephrectomy (LDN', 'transversus abdominis plane block and intrathecal morphine', 'intravenous fentanyl, ultrasound-guided TAP block or ITM', 'morphine']","['Postoperative 24-h patient-controlled analgesia (PCA) fentanyl consumption, visual analogue scale (VAS) score and intraoperative fentanyl and muscle relaxant requirements', 'Haemodynamic stability', 'analgesic efficacy', 'Postoperative VAS at rest and on movement', 'postoperative PCA fentanyl requirement', 'Intraoperative rescue fentanyl requirement', 'postoperative fentanyl requirement']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0411257', 'cui_str': 'Donor nephrectomy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0411257', 'cui_str': 'Donor nephrectomy'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0026827', 'cui_str': 'Decreased muscle tone'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",60.0,0.21334,"Postoperative VAS at rest and on movement was significantly lower in the morphine group at all points of assessment ( P  = 0.000).
","[{'ForeName': 'Sathianarayanan', 'Initials': 'S', 'LastName': 'Srinivasan', 'Affiliation': 'Department of Anesthesiology, Pain Medicine and Critical Care, New Delhi, India.'}, {'ForeName': 'Rajeshwari', 'Initials': 'R', 'LastName': 'Subramaniam', 'Affiliation': 'Department of Anesthesiology, Pain Medicine and Critical Care, New Delhi, India.'}, {'ForeName': 'Anjolie', 'Initials': 'A', 'LastName': 'Chhabra', 'Affiliation': 'Department of Anesthesiology, Pain Medicine and Critical Care, New Delhi, India.'}, {'ForeName': 'Dalim K', 'Initials': 'DK', 'LastName': 'Baidya', 'Affiliation': 'Department of Anesthesiology, Pain Medicine and Critical Care, New Delhi, India.'}, {'ForeName': 'Mahesh K', 'Initials': 'MK', 'LastName': 'Arora', 'Affiliation': 'Department of Anesthesiology, Pain Medicine and Critical Care, New Delhi, India.'}, {'ForeName': 'Souvik', 'Initials': 'S', 'LastName': 'Maitra', 'Affiliation': 'Department of Anesthesiology, Pain Medicine and Critical Care, New Delhi, India.'}, {'ForeName': 'Virender K', 'Initials': 'VK', 'LastName': 'Bansal', 'Affiliation': 'Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Hemanga K', 'Initials': 'HK', 'LastName': 'Bhattacharjee', 'Affiliation': 'Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_868_19']
2586,32792736,Effect of liberal versus restrictive fluid therapy on intraoperative lactate levels in robot- assisted colorectal surgery.,"Background and Aims


Minimally invasive and robotic surgeries need lesser fluid replacement but the role of restricted fluids in robotic surgeries other than prostatic surgeries has not been clearly defined. Our primary aim was to evaluate the effects of a restrictive fluid regimen versus a liberal policy on intra-operative lactate in robotic colorectal surgery. Secondary outcomes were need for vasopressors, extubation on table, post-operative renal functions and length of ICU (LOICU) stay.
Methods


American society of anaesthesiologists (ASA) physical status I-II patients scheduled for robot-assisted colorectal surgery were randomised into one of two groups, receiving either 2 mL/kg/h (Group R) or 4mL/kg/h, (group L). Fluid boluses of 250 ml were administered if mean arterial pressure (MAP) <65 mmHg or urine output <0.5 ml/kg/h. Norepinephrine was added for the blood pressure after 2 fluid boluses. Surgical field was assessed by modified Boezaart's scale and surgeon satisfaction by Likert scale.
Results


Demographics and baseline renal functions were comparable. Adjusted intra-operative lactate at 2 h, 4 h, and 6 h and need for noradrenaline and post-operative creatinine were similar. One patient in the group L was ventilated due to hypothermia. The field was better at the 4 h in group R and comparable at other time points. The LOICU stay was longer in Group L.
Conclusion


The use of restrictive fluid strategy of 2 mL/kg/h (group R) does not increase lactate levels or creatinine, improves surgical field at 4 h and shortens ICU stay in comparison to a liberal 4 mL/kg/h (group L) in robotic colorectal surgery.",2020,"The use of restrictive fluid strategy of 2 mL/kg/h (group R) does not increase lactate levels or creatinine, improves surgical field at 4 h and shortens ICU stay in comparison to a liberal 4 mL/kg/h (group L) in robotic colorectal surgery.","['Methods\n\n\nAmerican society of anaesthesiologists (ASA) physical status', 'robot- assisted colorectal surgery', 'robotic colorectal surgery']","['I-II patients scheduled for robot-assisted colorectal surgery', 'Norepinephrine', 'restrictive fluid regimen', 'liberal versus restrictive fluid therapy']","['blood pressure', 'LOICU stay', 'Adjusted intra-operative lactate at 2 h, 4 h, and 6 h and need for noradrenaline and post-operative creatinine', 'lactate levels or creatinine, improves surgical field at 4 h and shortens ICU stay', 'intraoperative lactate levels', 'need for vasopressors, extubation on table, post-operative renal functions and length of ICU (LOICU) stay']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}]","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",250.0,0.184313,"The use of restrictive fluid strategy of 2 mL/kg/h (group R) does not increase lactate levels or creatinine, improves surgical field at 4 h and shortens ICU stay in comparison to a liberal 4 mL/kg/h (group L) in robotic colorectal surgery.","[{'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Kumar', 'Affiliation': 'Department of Anaesthesiology, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}, {'ForeName': 'Kalyan', 'Initials': 'K', 'LastName': 'Kumar', 'Affiliation': 'Department of Anaesthesiology, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}, {'ForeName': 'Sai', 'Initials': 'S', 'LastName': 'Sandhya', 'Affiliation': 'Department of Anaesthesiology, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}, {'ForeName': 'Deepa M', 'Initials': 'DM', 'LastName': 'Koshy', 'Affiliation': 'Department of Anaesthesiology, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}, {'ForeName': 'Kruthika P', 'Initials': 'KP', 'LastName': 'Ramamurthi', 'Affiliation': 'Department of Anaesthesiology, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Rajan', 'Affiliation': 'Department of Anaesthesiology, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_401_20']
2587,32797070,Learning new sport actions: Pilot study to investigate the imitative and the verbal instructive teaching methods in motor education.,"The aim of the project was to investigate the effects of two strategies of teaching new sport actions on performance of eight-year-old children: observational-imitative method (OIM) and descriptive-directive method (DDM). The OIM group was provided with a pre-practice instruction in the form of expert modeling observation by an expert athlete. The DDM group received only verbal explanations of few selected static images. Thirty-six children (18 males and 18 females, mean age = 8,8) participated in the experiment. Subjects were randomly assigned to the OIM or DDM groups. Participants were instructed to perform four sport motor sequences never performed before (shoulder stand, soccer action, vortex howler throw, step action). Actions were videotaped and 2D kinematic analysis performed. A 10-point Likert questionnaire was administered to blind sport experts to assess the correctness and accuracy of each action. Results suggest that the OIM is the most effective instruction method when participants have no experience with the sport action to be performed. On the contrary, if the athlete needs to learn specific aspects of an exercise (such as grasping a tool) the best method is the DDM. In fact, detailed information on how to grab the vortex helped children in throwing it. We also found gender differences which might reflect cultural influences in specific sports (e.g. soccer). Finally, repetition of the exercise also improved the DDM group's performance. This has potential applications in sport teaching, suggesting that in the absence of a model performing the action to be imitated, the DDM can be as effective as the OIM if the observer repeats the sport action many times.",2020,Results suggest that the OIM is the most effective instruction method when participants have no experience with the sport action to be performed.,"['eight-year-old children', 'Thirty-six children (18 males and 18 females, mean age = 8,8) participated in the experiment']","['teaching new sport actions', 'OIM or DDM']",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",[],36.0,0.0155288,Results suggest that the OIM is the most effective instruction method when participants have no experience with the sport action to be performed.,"[{'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'De Stefani', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Rodà', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Elio', 'Initials': 'E', 'LastName': 'Volta', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Pincolini', 'Affiliation': 'Giocampus Steering Committee, Parma, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Farnese', 'Affiliation': 'Giocampus Steering Committee, Parma, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Rossetti', 'Affiliation': 'Giocampus Steering Committee, Parma, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Pedretti', 'Affiliation': 'Giocampus Steering Committee, Parma, Italy.'}, {'ForeName': 'Pier Francesco', 'Initials': 'PF', 'LastName': 'Ferrari', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}]",PloS one,['10.1371/journal.pone.0237697']
2588,32797125,Ubiquinol supplementation modulates energy metabolism and bone turnover during high intensity exercise.,"Bone and energy metabolism are profoundly influenced by exercise. The objective of this study was to determine for the first time whether a short-term supplementation with ubiquinol could have a modulating effect on bone turnover and energy metabolism associated with strenuous exercise. The participants (n = 100 healthy and well-trained firemen) were randomly divided into two groups: ubiquinol group (ubiquinol (200 mg day-1)) and control group (placebo) for two weeks. The protocol consisted of conducting two identical strenuous exercise tests with a rest period between tests of 24 h. Blood samples were collected before supplementation (basal value) (T1), after supplementation (T2), after the first physical exercise test (T3), after 24 h of rest (T4), and after the second physical exercise test (T5). Parathyroid hormone (PTH), osteocalcin (OC), osteoprotegerin (OPG), osteopontin (OPN), sclerotin (SOST), alkaline phosphatase (AP), adrenocorticotropin (ACTH), insulin, leptin, adrenaline, noradrenaline and peroxisome proliferator activated receptor-γ coactivator-1α (PGC-1α) were determined. Our protocol increased ACTH, SOST, PTH and OC levels, while it decreased OPN. This protocol also increased adrenaline, noradrenaline and PCG-1α, and decreased insulin. After ubiquinol supplementation, PTH, OC, OPG, alkaline phosphatase, leptin, insulin, noradrenaline and PGC-1α levels increased in the supplemented group compared to the control group after the exercise protocol. Strenuous exercise has a clear effect on energy metabolism and bone turnover. These effects are modulated by ubiquinol supplementation, which especially increases the biomarkers of bone formation during strenuous exercise. In addition, ubiquinol has a beneficial effect on the mobilization of energy sources, fact that it could represent an ergogenic and physiological advantage for skeletal muscles.",2020,"After ubiquinol supplementation, PTH, OC, OPG, alkaline phosphatase, leptin, insulin, noradrenaline and PGC-1α levels increased in the supplemented group compared to the control group after the exercise protocol.",['participants (n = 100 healthy and well-trained firemen'],"['ubiquinol group (ubiquinol (200 mg day-1)) and control group (placebo', 'Ubiquinol supplementation', 'Strenuous exercise']","['Parathyroid hormone (PTH), osteocalcin (OC), osteoprotegerin (OPG), osteopontin (OPN), sclerotin (SOST), alkaline phosphatase (AP), adrenocorticotropin (ACTH), insulin, leptin, adrenaline, noradrenaline and peroxisome proliferator activated receptor-γ coactivator-1α (PGC-1α', 'Bone and energy metabolism', 'ACTH, SOST, PTH and OC levels', 'PTH, OC, OPG, alkaline phosphatase, leptin, insulin, noradrenaline and PGC-1α levels', 'adrenaline, noradrenaline and PCG-1α, and decreased insulin', 'bone turnover and energy metabolism', 'energy metabolism and bone turnover']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}]","[{'cui': 'C0077656', 'cui_str': 'ubiquinol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0538161', 'cui_str': 'Tumor Necrosis Factor Receptor 11b'}, {'cui': 'C0069676', 'cui_str': 'Osteopontin'}, {'cui': 'C0074186', 'cui_str': 'sclerotin'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0166418', 'cui_str': 'PPAR'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0265301', 'cui_str': 'Sclerosteosis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030827', 'cui_str': 'Penicillin G'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}]",100.0,0.0563639,"After ubiquinol supplementation, PTH, OC, OPG, alkaline phosphatase, leptin, insulin, noradrenaline and PGC-1α levels increased in the supplemented group compared to the control group after the exercise protocol.","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Diaz-Castro', 'Affiliation': 'Department of Physiology, University of Granada, Granada, 18071, Spain and Institute of Nutrition and Food Technology ""José Mataix"", University of Granada, Granada, 18071, Spain. jjoh@ugr.es.'}, {'ForeName': 'Pablo Javier', 'Initials': 'PJ', 'LastName': 'Mira-Rufino', 'Affiliation': 'Institute of Nutrition and Food Technology ""José Mataix"", University of Granada, Granada, 18071, Spain. jjoh@ugr.es and Human Nutrition Ph.D. Program, University of Granada, Granada, 18071, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Moreno-Fernandez', 'Affiliation': 'Department of Physiology, University of Granada, Granada, 18071, Spain and Institute of Nutrition and Food Technology ""José Mataix"", University of Granada, Granada, 18071, Spain. jjoh@ugr.es.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Chirosa', 'Affiliation': 'Department of Physical Education, University of Granada, Granada, 18071, Spain.'}, {'ForeName': 'Javier Luis', 'Initials': 'JL', 'LastName': 'Chirosa', 'Affiliation': 'Department of Physical Education, University of Granada, Granada, 18071, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Guisado', 'Affiliation': 'Faculty of Health Sciences, University of Granada, Granada, 18071, Spain.'}, {'ForeName': 'Julio J', 'Initials': 'JJ', 'LastName': 'Ochoa', 'Affiliation': 'Department of Physiology, University of Granada, Granada, 18071, Spain and Institute of Nutrition and Food Technology ""José Mataix"", University of Granada, Granada, 18071, Spain. jjoh@ugr.es.'}]",Food & function,['10.1039/d0fo01147a']
2589,32797232,A Randomized Comparative Trial of Targeted Steroid Injection via Epidural Catheter vs Standard Transforaminal Epidural Injection for the Treatment of Unilateral Cervical Radicular Pain: Six-Month Results.,"OBJECTIVES


Compare the effectiveness of catheter-directed cervical interlaminar epidural steroid injection (C-CIESI) with triamcinolone to cervical transforaminal steroid injection (CTFESI) with dexamethasone for the treatment of refractory unilateral radicular pain.
DESIGN


Prospective, randomized, comparative trial.
METHODS


Primary outcome: proportion of participants with ≥50% numeric rating scale pain score reduction from baseline ""dominant pain"" (the greater of arm vs neck) at one month postinjection. Secondary outcomes: ≥30% Neck Disability Index (NDI-5) reduction and Patient Global Impression of Change (PGIC) response indicating ""much improved"" or ""very much improved.""
RESULTS


One hundred twenty participants (55.6% females, 52.3 ± 12.5 years of age, BMI 28.2 ± 6.5 kg/m2), were enrolled. The proportions of participants who experienced ≥50% pain reduction at one, three, and six months were 68.5% (95% CI = 54.9-79.5%), 59.3% (95% CI = 45.7-71.6%), and 60.8% (95% CI = 46.7-73.2%), respectively, in the C-CIESI group compared with 49.1% (95% CI = 36.4-62.0%), 46.4% (95% CI = 33.8-59.6%), and 51.9% (95% CI = 38.4-65.2%), respectively, in the CTFESI group. The between-group difference at one month was significant (P = 0.038). The proportions of participants who experienced a ≥30% NDI-5 score improvement were 64.0% (95% CI = 49.8-76.1%) and 54.9% (95% CI = 41.1-68.0%) in the C-CIESI and CTFESI groups (P = 0.352). Participants reported similar PGIC improvement in both groups: At six months, 53.2% (95% CI 38.9-67.1%) and 54.5% (95% CI = 39.7-68.7%) of the C-CIESI and CTFESI groups reported being ""much improved"" or ""very much improved,"" respectively (P = 0.897).
CONCLUSIONS


Both C-CIESI with triamcinolone and CTFESI with dexamethasone are effective in reducing pain and disability associated with refractory unilateral cervical radiculopathy in a substantial proportion of participants for at least six months.",2020,"Participants reported similar PGIC improvement in both groups: At six months, 53.2% (95% CI 38.9-67.1%) and 54.5% (95% CI = 39.7-68.7%) of the C-CIESI and CTFESI groups reported being ""much improved"" or ""very much improved,"" respectively (P = 0.897).
","['One hundred twenty participants (55.6% females, 52.3\u2009±\u200912.5\u2009years of age, BMI 28.2\u2009±\u20096.5\u2009kg/m2), were enrolled', 'Unilateral Cervical Radicular Pain']","['triamcinolone', 'catheter-directed cervical interlaminar epidural steroid injection (C-CIESI', 'dexamethasone', 'triamcinolone and CTFESI with dexamethasone', 'Steroid Injection via Epidural Catheter vs Standard Transforaminal Epidural Injection']","['NDI-5 score improvement', 'pain reduction', 'pain and disability', 'PGIC improvement', 'Neck Disability Index (NDI-5) reduction and Patient Global Impression of Change (PGIC) response indicating ""much improved"" or ""very much improved', 'proportion of participants with ≥50% numeric rating scale pain score reduction from baseline ""dominant pain']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C4552559', 'cui_str': 'Cervical radicular pain'}]","[{'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0196394', 'cui_str': 'Epidural steroid injection'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}, {'cui': 'C0179751', 'cui_str': 'Epidural catheter'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021486', 'cui_str': 'Injections, Peridural'}]","[{'cui': 'C1563705', 'cui_str': 'Diabetes Insipidus, Nephrogenic, Type I'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0442824', 'cui_str': 'Very'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",120.0,0.176804,"Participants reported similar PGIC improvement in both groups: At six months, 53.2% (95% CI 38.9-67.1%) and 54.5% (95% CI = 39.7-68.7%) of the C-CIESI and CTFESI groups reported being ""much improved"" or ""very much improved,"" respectively (P = 0.897).
","[{'ForeName': 'Zachary L', 'Initials': 'ZL', 'LastName': 'McCormick', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Conger', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Beau P', 'Initials': 'BP', 'LastName': 'Sperry', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Teramoto', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Petersen', 'Affiliation': 'Alabama College of Osteopathic Medicine, Dothan, Alabama.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Salazar', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Shellie', 'Initials': 'S', 'LastName': 'Cunningham', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Michael Henrie', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Bisson', 'Affiliation': 'Department of Neurosurgery, University of Utah School of Medicine, Salt Lake City, Utah, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kendall', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa242']
2590,32797236,Intravenous Paracetamol vs Intranasal Desmopressin for Renal Colic in the Emergency Department: A Randomized Clinical Trial.,"OBJECTIVE


To evaluate the analgesic efficacy of intranasal desmopressin alone vs intravenous paracetamol in patients referred to the emergency department with renal colic.
DESIGN


Randomized clinical trial.
SETTING


This study was conducted in the emergency unit of a university hospital.
SUBJECTS


Patients referred to the emergency room with renal colic.
PRIMARY OUTCOME


Effect of intranasal desmopressin in pain relief in comparison with intravenous paracetamol.
METHODS


In this trial, 240 patients diagnosed with renal colic were randomly divided into two groups to compare the analgesic effect of intravenous paracetamol (15 mg/kg) and intranasal desmopressin spray (40 μg). Pain scores were measured by a numeric rating scale at baseline and after 15, 30, and 60 minutes. Adverse effects and need for rescue analgesic (0.05 mg/kg max 3 mg morphine sulphate) were also recorded at the end of the study.
RESULTS


Three hundred patients were eligible for the study; however, 240 were included in the final analysis. The patients in the two groups were similar in their baseline characteristics and baseline pain scores. The mean pain score after 15 minutes was more reduced and was clinically significant (>3) in the desmopressin group (P < 0.0001). There was no significant difference between mean pain scores in the two groups after 30 minutes (P = 0.350) or 60 minutes (P = 0.269), but the efficacy of the two drugs was significant in terms of pain reduction (>6).
CONCLUSIONS


Our study showed that intranasal desmopressin is as effective as intravenous paracetamol for renal colic pain management; however, significant clinical reduction in pain score occurred faster with intranasal desmopressin.",2020,"There was no significant difference between mean pain scores in the two groups after 30 minutes (P = 0.350) or 60 minutes (P = 0.269), but the efficacy of the two drugs was significant in terms of pain reduction (>6).
","['patients referred to the emergency department with renal colic', 'Patients referred to the emergency room with renal colic', '240 patients diagnosed with renal colic', 'Renal Colic in the Emergency Department', 'emergency unit of a university hospital', 'Three hundred patients were eligible for the study; however, 240 were included in the final analysis']","['intravenous paracetamol', 'Intravenous Paracetamol', 'morphine sulphate', 'intranasal desmopressin', 'intranasal desmopressin alone vs intravenous paracetamol', 'intranasal desmopressin spray', 'Intranasal Desmopressin', 'paracetamol', 'desmopressin']","['baseline pain scores', 'pain relief', 'pain reduction', 'analgesic efficacy', 'numeric rating scale', 'mean pain scores', 'mean pain score', 'pain score', 'Pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0066814', 'cui_str': 'Morphine sulfate'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0011701', 'cui_str': 'desmopressin'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",240.0,0.179194,"There was no significant difference between mean pain scores in the two groups after 30 minutes (P = 0.350) or 60 minutes (P = 0.269), but the efficacy of the two drugs was significant in terms of pain reduction (>6).
","[{'ForeName': 'Hamed Basir', 'Initials': 'HB', 'LastName': 'Ghafouri', 'Affiliation': 'Emergency Medicine, Trauma and Injury Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Abazarian', 'Affiliation': 'Emergency Medicine, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Yasinzadeh', 'Affiliation': 'Emergency Medicine, Trauma and Injury Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Modirian', 'Affiliation': 'Emergency Medicine, Qazvin University of Medical Sciences, Qazvin, Iran.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa240']
2591,32796329,Modified Buried Vertical Mattress Suture Versus Buried Intradermal Suture: A Prospective Split-Scar Study.,"BACKGROUND


The modified buried vertical mattress suture (MBVMS) is believed to provide excellent outcomes by relieving the tension on wound edges. However, clinical data on the topic remain sparse and inadequate.
OBJECTIVE


To compare the cosmetic results of the MBVMS and the buried intradermal suture (BIS) in chest wounds using a split-scar model.
MATERIALS AND METHODS


Twenty patients participated in the study. One randomly selected half of each chest wound was closed with the MBVMS; the other half was closed with the BIS. Immediately, postoperatively, the maximum degree of wound eversion was obtained. After 3 months, the wound complication rates were recorded, and the aesthetic appearance of each scar was evaluated by the Patient and Observer Scar Assessment Scale (POSAS), the Vancouver Scar Scale (VSS), the visual analog scale (VAS), and scar width.
RESULTS


The MBVMS yielded a greater mean postoperative eversion height and width (p < .05); lower POSAS, VSS, and VAS scores (p < .05); and a narrower scar width (p < .05) than did the BIS.
CONCLUSION


Compared with the BIS, the MBVMS provided significantly increased wound eversion immediately, postoperatively, and improved aesthetic outcomes at the end of the 3-month follow-up period.",2020,"Compared with the BIS, the MBVMS provided significantly increased wound eversion immediately, postoperatively, and improved aesthetic outcomes at the end of the 3-month follow-up period.",['Twenty patients participated in the study'],"['modified buried vertical mattress suture (MBVMS', 'Modified Buried Vertical Mattress Suture Versus Buried Intradermal Suture', 'MBVMS and the buried intradermal suture (BIS']","['POSAS, VSS, and VAS scores', 'aesthetic appearance of each scar', 'wound complication rates', 'wound eversion', 'Patient and Observer Scar Assessment Scale (POSAS), the Vancouver Scar Scale (VSS), the visual analog scale (VAS), and scar width', 'aesthetic outcomes', 'narrower scar width', 'mean postoperative eversion height and width', 'maximum degree of wound eversion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0263398', 'cui_str': 'Erythema elevatum diutinum'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0024940', 'cui_str': 'Mattress'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0015211', 'cui_str': 'Eversion'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",1.0,0.0127069,"Compared with the BIS, the MBVMS provided significantly increased wound eversion immediately, postoperatively, and improved aesthetic outcomes at the end of the 3-month follow-up period.","[{'ForeName': 'Zonghui', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Aesthetic, Plastic and Maxillofacial Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Zhishui', 'Initials': 'Z', 'LastName': 'Tang', 'Affiliation': ""Department of Aesthetic, Plastic and Maxillofacial Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Hao', 'Affiliation': ""Department of Aesthetic, Plastic and Maxillofacial Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Aesthetic, Plastic and Maxillofacial Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'He', 'Affiliation': ""Department of Aesthetic, Plastic and Maxillofacial Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xueyuan', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': ""Department of Aesthetic, Plastic and Maxillofacial Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ""Department of Aesthetic, Plastic and Maxillofacial Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Youcheng', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': ""Department of Aesthetic, Plastic and Maxillofacial Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': ""Department of Aesthetic, Plastic and Maxillofacial Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Maoguo', 'Initials': 'M', 'LastName': 'Shu', 'Affiliation': ""Department of Aesthetic, Plastic and Maxillofacial Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002642']
2592,32798197,"Effects of the pestle needle therapy, a type of acupoint stimulation, on post-hemorrhoidectomy pain: A randomized controlled trial.","BACKGROUND


Hemorrhoids are one of the most common conditions that lead to surgery, and until now surgical hemorrhoidectomy has been the major effective treatment. Post-operative pain from hemorrhoidectomy has been experienced by thousands of patients and remains a major inconvenience of the operation.
OBJECTIVE


This study evaluates the clinical efficacy of the pestle needle therapy, an acupoint stimulation method, for relief of post-hemorrhoidectomy pain.
DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS


This was a single-center, patient-assessor-blinded and randomized controlled trial with 154 patients receiving Milligan hemorrhoidectomy surgery. Eligible patients were randomly assigned to either a treatment group or a control group at a ratio of 1:1. The treatment group received the pestle needle therapy, with manual stimulation at Yaoshu (DU2), Mingmen (DU4), Changqiang (DU1), Chengshan (BL57), Erbai (EX-UE2) and the perianal points (1, 3, 5, 7, 9, and 11o'clock around the lesion); while the control group received a sham treatment with very light pressure. Three sessions of treatment were performed at 30 min, 4 h and 12 h after the surgery, and each lasted for 15 min.
MAIN OUTCOME MEASURES


The primary outcome was post-operative pain measured with the visual analogue scale (VAS) at 12 h after surgery. The secondary outcomes included the VAS scores measured at 0.5, 2, 4, 6, 8, 24 and 48 h after surgery, the analgesic dose, the time and the VAS score of the patients' first defecation after surgery, as well as the Hamilton Rating Scale for Anxiety (HAMA) evaluated before discharge.
RESULTS


The mean pain score of the treatment group was significantly lower than that of the control group (3.10 ± 1.27 vs 4.82 ± 1.29; P < 0.001) at 12 h after surgery. Compared with the control group, patients in the treatment group needed a smaller dose of analgesic within the first 24 hours after surgery (P = 0.002); and their HAMA scores before discharge were lower (4.07 ± 2.40 vs 5.10 ± 2.45, P = 0.009). Compared to the treatment group, patients in the control group had a greater time to the first defecation after surgery ([52.34 ± 15.72] h vs [27.08 ± 13.68] h; P < 0.001), but there was no difference in their VAS scores at the first defecation (P = 0.092).
CONCLUSION


The pestle needle therapy was effective for relieving pain, reducing anxiety and improving bowel function after hemorrhoidectomy, and it is worthy of clinical application.",2020,"The pestle needle therapy was effective for relieving pain, reducing anxiety and improving bowel function after hemorrhoidectomy, and it is worthy of clinical application.","['post-hemorrhoidectomy pain', '154 patients receiving', 'Eligible patients']","['pestle needle therapy', 'pestle needle therapy, with manual stimulation at Yaoshu (DU2), Mingmen (DU4), Changqiang (DU1), Chengshan (BL57), Erbai (EX-UE2', 'sham treatment with very light pressure', 'Milligan hemorrhoidectomy surgery']","['HAMA scores before discharge', 'greater time to the first defecation', ""analgesic dose, the time and the VAS score of the patients' first defecation"", 'post-operative pain measured with the visual analogue scale (VAS', 'mean pain score', 'Hamilton Rating Scale for Anxiety (HAMA', 'relieving pain, reducing anxiety and improving bowel function', 'VAS scores']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439538', 'cui_str': 'Very light'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",154.0,0.0722755,"The pestle needle therapy was effective for relieving pain, reducing anxiety and improving bowel function after hemorrhoidectomy, and it is worthy of clinical application.","[{'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Yin', 'Affiliation': 'Department of Acupuncture and Moxibustion, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China.'}, {'ForeName': 'Xiu-Tian', 'Initials': 'XT', 'LastName': 'Guo', 'Affiliation': 'Department of Proctology, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China.'}, {'ForeName': 'Wen-Qi', 'Initials': 'WQ', 'LastName': 'Jin', 'Affiliation': 'Department of Proctology, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China.'}, {'ForeName': 'Ai-Jun', 'Initials': 'AJ', 'LastName': 'Mao', 'Affiliation': 'Department of Nursing, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China.'}, {'ForeName': 'Lixing', 'Initials': 'L', 'LastName': 'Lao', 'Affiliation': 'School of Chinese Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China; Virginia University of Integrative Medicine, Fairfax, VA 22031, USA.'}, {'ForeName': 'Zhang-Jin', 'Initials': 'ZJ', 'LastName': 'Zhang', 'Affiliation': 'School of Chinese Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Nursing, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China. Electronic address: chengyong2002@126.com.'}, {'ForeName': 'Shi-Fen', 'Initials': 'SF', 'LastName': 'Xu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China. Electronic address: xu_teacher2006@126.com.'}]",Journal of integrative medicine,['10.1016/j.joim.2020.08.001']
2593,32798224,One-year decline of poliovirus antibodies following fractional-dose inactivated poliovirus vaccine.,"BACKGROUND


Fractional dose (1/5th of full intramuscular dose) of inactivated poliovirus-vaccine administered intradermally (fIPV) is used as IPV dose-sparing strategy. We compared the rate of decline of poliovirus antibodies (PVA) in recipients of either two doses of fIPV or IPV.
METHODS


Community-based randomized controlled trial was conducted in Karachi, Pakistan. Children aged 14 weeks were randomized into fIPV or full IPV study arms (A, B) and received one vaccine doses at 14 weeks and one at 9 months of age. PVA were measured at 14, 18 weeks and 10, 21 months of age.
RESULTS


Seroprevalence of poliovirus-type 2 antibodies of 170/250 (68%) enrolled children after two IPV or fIPV doses at 10 months of age in arms-A and B reached 100% vs 99% (p=0.339); and at 21 months it was 86% vs 67% (p=0.004). Between 10 and 21 months of age, the antibody-titers in log2 scale dropped from >=10.5 to 6.8 in arm-A; and from 9.2 to 3.7 in arm B.
INTERPRETATION


A significant decline in antibody titers12 months following second IPV dose. The slope of decline is similar for both full IPV and fIPV recipients. The results provide further evidence that fIPV is a viable option for IPV dose-sparing.",2020,"Between 10 and 21 months of age, the antibody-titers in log2 scale dropped from >=10.5 to 6.8 in arm-A; and from 9.2 to 3.7 in arm B.
INTERPRETATION


A significant decline in antibody titers12 months following second IPV dose.","['Community-based randomized controlled trial was conducted in Karachi, Pakistan', 'recipients of either two doses of fIPV or IPV', 'Children aged 14 weeks']","['inactivated poliovirus-vaccine administered intradermally (fIPV', 'fractional-dose inactivated poliovirus vaccine']","['antibody-titers in log2 scale', 'poliovirus antibodies', 'PVA', 'rate of decline of poliovirus antibodies (PVA']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0085305', 'cui_str': 'Feline infectious peritonitis virus'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0036106', 'cui_str': 'Salk Vaccine'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0085305', 'cui_str': 'Feline infectious peritonitis virus'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0206435', 'cui_str': 'Human poliovirus'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",,0.169346,"Between 10 and 21 months of age, the antibody-titers in log2 scale dropped from >=10.5 to 6.8 in arm-A; and from 9.2 to 3.7 in arm B.
INTERPRETATION


A significant decline in antibody titers12 months following second IPV dose.","[{'ForeName': 'Ali Faisal', 'Initials': 'AF', 'LastName': 'Saleem', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Ondrej', 'Initials': 'O', 'LastName': 'Mach', 'Affiliation': 'Polio Eradication Department, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Mohammad Tahir', 'Initials': 'MT', 'LastName': 'Yousafzai', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Zaubina', 'Initials': 'Z', 'LastName': 'Kazi', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Attaullah', 'Initials': 'A', 'LastName': 'Baig', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Sajid', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Vishali', 'Initials': 'V', 'LastName': 'Jeyaseelan', 'Affiliation': 'Polio Eradication Department, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Roland W', 'Initials': 'RW', 'LastName': 'Sutter', 'Affiliation': 'Polio Eradication Department, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Anita K M', 'Initials': 'AKM', 'LastName': 'Zaidi', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa504']
2594,32798261,"The effect of saffron supplementation on some inflammatory and oxidative markers, leptin, adiponectin, and body composition in patients with nonalcoholic fatty liver disease: A double-blind randomized clinical trial.","BACKGROUND


Nonalcoholic fatty liver disease (NAFLD) is characterized by oxidative stress and inflammation in the hepatocytes. Saffron and its constituents are reported to have several properties such as anti-inflammatory and anti-diabetic effects.
MATERIALS AND METHODS


In a randomized double-blind placebo-controlled trial with two parallel groups including 76 eligible men and female patients with NAFLD aged 18-65, recruited from Hazrat Rasul Akram Hospital in Tehran, Iran. NAFLD was defined by a Gastroenterologist based on the American Gastrointestinal and Liver Association standards. Participants were randomly assigned to two groups receiving daily supplementation of either one tablet of 100 mg saffron (n = 38) or one placebo (n = 38) for 12 weeks. The primary outcome was high sensitive C-reactive protein (hs-CRP) and secondary outcomes were alanine aminotransferase (ALT), aspartate aminotransferase (AST), tumor necrosis factor alpha (TNF-α), malondialdehyde (MDA), total anti-oxidant capacity (TAC), leptin, adiponectin, anthropometric, and body composition Both groups were assigned similar diet and physical activity.
RESULTS


In the treatment group, significant decreases in hs-CRP (-1.80 ng/ml, 95% CI = -2.97, -0.63, p = .032), leptin (-0.27 ng/ml, 95% CI = -0.65, -0.10, p = .040), MDA (-1.01 ng/ml, 95% CI = -1.89, -0.14, p = .023) and significant increase in TAC (0.34 μmol/L, 95% CI = 0.08, 0.61, p = .011) were observed compared to the placebo group. However, there were no significant changes in serum alanine aminotransferase, AST, TNF-α, body composition, and anthropometric indexes (p > .05).
CONCLUSION


In the present study, 12 weeks of 100 mg of saffron supplementation indicated beneficial effects on serum levels of some inflammatory, oxidative stress, and adipokines biomarkers but it had no significant effect on serum concentrations of liver enzymes, anthropometric, and body composition measurements.",2020,"In the treatment group, significant decreases in hs-CRP (-1.80 ng/ml, 95% CI = -2.97, -0.63, p = .032), leptin (-0.27 ng/ml, 95% CI = -0.65,","['patients with nonalcoholic fatty liver disease', '76 eligible men and female patients with NAFLD aged 18-65, recruited from Hazrat Rasul Akram Hospital in Tehran, Iran']","['saffron supplementation', 'daily supplementation of either one tablet of 100\u2009mg saffron', 'placebo']","['serum alanine aminotransferase, AST, TNF-α, body composition, and anthropometric indexes', 'serum concentrations of liver enzymes, anthropometric, and body composition measurements', 'inflammatory and oxidative markers, leptin, adiponectin, and body composition', 'leptin', 'high sensitive C-reactive protein (hs-CRP) and secondary outcomes were alanine aminotransferase (ALT), aspartate aminotransferase (AST), tumor necrosis factor alpha (TNF-α), malondialdehyde (MDA), total anti-oxidant capacity (TAC), leptin, adiponectin, anthropometric, and body composition', 'MDA', 'TAC', 'serum levels of some inflammatory, oxidative stress, and adipokines biomarkers', 'hs-CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0162753', 'cui_str': 'Saffron Stain'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",,0.674433,"In the treatment group, significant decreases in hs-CRP (-1.80 ng/ml, 95% CI = -2.97, -0.63, p = .032), leptin (-0.27 ng/ml, 95% CI = -0.65,","[{'ForeName': 'Farnaz Kaviani', 'Initials': 'FK', 'LastName': 'Pour', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Naheed', 'Initials': 'N', 'LastName': 'Aryaeian', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Mokhtare', 'Affiliation': 'Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reyhane Sadat', 'Initials': 'RS', 'LastName': 'Mirnasrollahi Parsa', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Jannani', 'Affiliation': 'Department of Biostatistics, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Agah', 'Affiliation': 'Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sodabeh', 'Initials': 'S', 'LastName': 'Fallah', 'Affiliation': 'Department of Clinical Biochemistry, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nariman', 'Initials': 'N', 'LastName': 'Moradi', 'Affiliation': 'Department of Clinical Biochemistry, Faculty of Medicine, Kurdistan University of Medical Sciences, Sanandaj, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6791']
2595,32798283,Nuclease Therapy Improves Severe Fatigue in Primary Sjögren's Syndrome: A Randomized Clinical Trial.,"OBJECTIVE


To assess the safety and efficacy of RSLV-132, an RNase Fc fusion protein in a phase II randomized, double-blind, placebo-controlled clinical trial in patients with primary Sjögren's syndrome (pSS).
METHODS


Thirty patients were randomized to receive intravenous RSLV-132 or placebo, weekly for two weeks then every two weeks for twelve weeks. Eight subjects received placebo and twenty received RSLV-132, 10 mg/kg. Clinical efficacy measures included the European League Against Rheumatism (EULAR) Sjögren's syndrome disease activity index (ESSDAI), EULAR Sjögren's syndrome patient reported index (ESSPRI), FACIT fatigue (FACIT-F), and profile of fatigue (ProF), and the digit symbol substitution test (DSST).
RESULTS


Patients randomized to RSLV-132, but not placebo, experienced clinically meaningful improvements in ESSPRI, FACIT-F, ProF, and DSST. This improvement was correlated with increased expression of selected interferon-inducible genes.
CONCLUSION


Administration of RSLV-132 improved severe fatigue in pSS patients as determined by four independent measures of fatigue.",2020,"RESULTS


Patients randomized to RSLV-132, but not placebo, experienced clinically meaningful improvements in ESSPRI, FACIT-F, ProF, and DSST.","[""Primary Sjögren's Syndrome"", ""patients with primary Sjögren's syndrome (pSS"", 'Thirty patients']","['Nuclease Therapy', 'RSLV-132', 'intravenous RSLV-132 or placebo', 'placebo']","['ESSPRI, FACIT-F, ProF, and DSST', 'expression of selected interferon-inducible genes', 'severe fatigue', ""Sjögren's syndrome disease activity index (ESSDAI), EULAR Sjögren's syndrome patient reported index (ESSPRI), FACIT fatigue (FACIT-F), and profile of fatigue (ProF), and the digit symbol substitution test (DSST"", 'Severe Fatigue', 'European League Against Rheumatism (EULAR']","[{'cui': 'C0151449', 'cui_str': ""Primary Sjögren's syndrome""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0597094', 'cui_str': 'Nuclease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4705323', 'cui_str': 'RSLV-132'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1527336', 'cui_str': ""Sjögren's syndrome""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0009326', 'cui_str': 'Collagen disease'}]",30.0,0.53509,"RESULTS


Patients randomized to RSLV-132, but not placebo, experienced clinically meaningful improvements in ESSPRI, FACIT-F, ProF, and DSST.","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Posada', 'Affiliation': 'Resolve Therapeutics, St. Petersburg, FL.'}, {'ForeName': 'Saba', 'Initials': 'S', 'LastName': 'Valadkhan', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, United States.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Burge', 'Affiliation': 'Resolve Therapeutics, St. Petersburg, FL.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Davies', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Tarn', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Casement', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Jobling', 'Affiliation': 'Newcastle Biomedical Research Centre and Newcastle upon Tyne Hospital NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gallagher', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Wilson', 'Affiliation': 'Q2 Solutions, Morrisville, NC.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Barone', 'Affiliation': 'Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Fisher', 'Affiliation': 'Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Wan-Fai', 'Initials': 'WF', 'LastName': 'Ng', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41489']
2596,32798112,"Percutaneous reduction, cannulated screw fixation and calcium sulfate cement grafting assisted by 3D printing technology in the treatment of calcaneal fractures.","BACKGROUND


Percutaneous reduction, cannulated screw fixation and calcium sulfate cement grafting (PR + CSC) for treatment of displaced and intra-articular calcaneal fractures (DIACFs) is a difficult technique, because the minimally invasive treatment has limited exposure and cannot be used to reduce articular surface under direct vision. The goal of this study was to apply 3D printing technology to preoperative planning and surgery of DIACFs, and to evaluate its effectiveness, feasibility and safety in fracture repair.
METHODS


We enrolled 81 patients with DIACFs in the study from August 2015 to August 2017. Patients with DIACFs in our hospital were randomly divided into the 3D printing group (40 cases) and the conventional group (41 cases). The operation duration, blood loss volume and the number of fluoroscopy were compared. Radiological results were evaluated using radiographs and functional results were evaluated using the American Orthopedic Foot and Ankle Society (AOFAS) score. The complications were also assessed. In addition, we made a questionnaire to verify the usefulness of the 3D printed model for both doctors and patients.
RESULTS


The operation duration, blood loss volume and the number of fluoroscopy in 3D printing group were significantly less than that in the conventional group. Besides, 3D printing group achieved significantly better radiological results than conventional group both postoperatively and at the final follow-up except the calcaneal width at the final follow-up. The AOFAS score in the 3D printing group was significantly higher than that in the conventional group. In addition, the questionnaire from doctors and patients exhibited high scores of overall satisfaction of the 3D printed models. As for complications, there was no significant difference among the two groups.
CONCLUSION


This study suggested the clinical feasibility of PR + CSC assisted by 3D printing technology in the treatment of DIACFs.
LEVEL OF EVIDENCE


II.",2020,"Besides, 3D printing group achieved significantly better radiological results than conventional group both postoperatively and at the final follow-up except the calcaneal width at the final follow-up.","['calcaneal fractures', 'Patients with DIACFs in our hospital', '81 patients with DIACFs in the study from August 2015 to August 2017']","['cannulated screw fixation and calcium sulfate cement grafting (PR\xa0+\xa0CSC', 'Percutaneous reduction, cannulated screw fixation and calcium sulfate cement grafting']","['American Orthopedic Foot and Ankle Society (AOFAS) score', 'radiological results', 'operation duration, blood loss volume and the number of fluoroscopy', 'AOFAS score']","[{'cui': 'C0006655', 'cui_str': 'Bone structure of calcaneum'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0006720', 'cui_str': 'Calcium Sulfate'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0730328', 'cui_str': 'Central serous chorioretinopathy'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]","[{'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}]",81.0,0.0180902,"Besides, 3D printing group achieved significantly better radiological results than conventional group both postoperatively and at the final follow-up except the calcaneal width at the final follow-up.","[{'ForeName': 'Gaole', 'Initials': 'G', 'LastName': 'Dai', 'Affiliation': ""Department of Orthopaedics, Key Laboratory of Orthopaedics of Zhejiang Province, The Second School of Medicine of Wenzhou Medical University, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Zhenxuan', 'Initials': 'Z', 'LastName': 'Shao', 'Affiliation': ""Department of Orthopaedics, Key Laboratory of Orthopaedics of Zhejiang Province, The Second School of Medicine of Wenzhou Medical University, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Qihao', 'Initials': 'Q', 'LastName': 'Weng', 'Affiliation': ""Department of Orthopaedics, Key Laboratory of Orthopaedics of Zhejiang Province, The Second School of Medicine of Wenzhou Medical University, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Yijing', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""Department of Orthopaedics, Key Laboratory of Orthopaedics of Zhejiang Province, The Second School of Medicine of Wenzhou Medical University, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Hong', 'Affiliation': ""Department of Orthopaedics, Key Laboratory of Orthopaedics of Zhejiang Province, The Second School of Medicine of Wenzhou Medical University, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China. Electronic address: JianjunHong123@126.com.""}, {'ForeName': 'Xiaolang', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': ""Department of Orthopaedics, Key Laboratory of Orthopaedics of Zhejiang Province, The Second School of Medicine of Wenzhou Medical University, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China. Electronic address: XiaolangLu@126.com.""}]",Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association,['10.1016/j.jos.2020.06.008']
2597,32792709,Comparative analgesic efficacy of intravenous vs intrathecal dexmedetomidine as an adjuvant to hyperbaric bupivacaine in subarachnoid block for below knee orthopaedic surgery.,"Background and Aim


Intrathecal and intravenous dexmedetomidine has been used as adjuvant in subarachnoid block [SAB]. The aim of this study was to compare the analgesic efficacy of intravenous vs intrathecal dexmedetomidine as adjuvant to intrathecal bupivacaine.
Methods


Ninety patients, aged 20-60 years belonging to American Society of Anaesthesiologists (ASA) physical status I and II, scheduled for below knee orthopaedic surgeries under SAB were enrolled. In group I ( n  = 45) patients received intravenous dexmedetomidine 0.5 μg/kg in 100 mL 0.9% normal saline [NS] intravenous over a period of 15 minutes given 20 minutes before SAB. Subarachnoid block was given with intrathecal (IT) 0.5% bupivacaine (H) 12.5 mg (2.5 mL) with 0.3 mL of NS. Patients in group II ( n  = 45) received 100 mL of 0.9% NS over a period of 15 minutes given 20 minutes before subarachnoid block. SAB was given with intrathecal 0.5% heavy bupivacaine 12.5 mg with 3 μg of dexmedetomidine (0.3 mL). The primary outcome was duration of analgesia and rescue analgesic requirement, whereas secondary outcome included pain scores.
Results


The duration of analgesia was prolonged in group II (median [IQR]: 5 (6-7.5) h than in group I (median[IQR]: 4[2-4.5] h,  P  = 0.000). Median dose of rescue analgesics over period of 24 hours was less in group II as compared to group I (median [IQR]:150 (75-150) mg vs 195 (150-225) mg,  P  = 0.000). VAS score was lower in group II till 12 h in the postoperative period ( P  = 0.00).
Conclusion


Intrathecal dexmedetomidine is more efficacious as compared to intravenous dexmedetomidine, due to favourable outcomes in terms of increased duration of postoperative analgesia and reduced rescue analgesic requirement.",2020,"The duration of analgesia was prolonged in group II (median [IQR]: 5 (6-7.5) h than in group I (median[IQR]: 4[2-4.5] h,  P  = 0.000).","['subarachnoid block for below knee orthopaedic surgery', 'Methods\n\n\nNinety patients, aged 20-60 years belonging to American Society of Anaesthesiologists (ASA', 'physical status I and II, scheduled for below knee orthopaedic surgeries under SAB were enrolled']","['bupivacaine', 'intrathecal (IT) 0.5% bupivacaine', 'SAB', 'hyperbaric bupivacaine', 'intravenous vs intrathecal dexmedetomidine', 'intravenous dexmedetomidine 0.5 μg/kg in 100 mL 0.9% normal saline [NS] intravenous', 'intrathecal 0.5% heavy bupivacaine', 'dexmedetomidine']","['pain scores', 'duration of analgesia', 'VAS score', 'analgesic efficacy', 'duration of analgesia and rescue analgesic requirement']","[{'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439166', 'cui_str': '% normal'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.269584,"The duration of analgesia was prolonged in group II (median [IQR]: 5 (6-7.5) h than in group I (median[IQR]: 4[2-4.5] h,  P  = 0.000).","[{'ForeName': 'Isha', 'Initials': 'I', 'LastName': 'Sharma', 'Affiliation': 'Department of Anesthesia, Dr Rajendra Medical Govt. College Kangra at Tanda, Himachal Pradesh, India.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Rana', 'Affiliation': 'Department of Anesthesia, Dr Rajendra Medical Govt. College Kangra at Tanda, Himachal Pradesh, India.'}, {'ForeName': 'Bharti', 'Initials': 'B', 'LastName': 'Choudhary', 'Affiliation': 'Department of Anesthesia, Dr Rajendra Medical Govt. College Kangra at Tanda, Himachal Pradesh, India.'}, {'ForeName': 'Tanvi', 'Initials': 'T', 'LastName': 'Dhiman', 'Affiliation': 'Department of Anesthesia, Dr Rajendra Medical Govt. College Kangra at Tanda, Himachal Pradesh, India.'}, {'ForeName': 'Sheena', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Anesthesia, Dr Rajendra Medical Govt. College Kangra at Tanda, Himachal Pradesh, India.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Kumar', 'Affiliation': 'Department of Anesthesia, Dr Rajendra Medical Govt. College Kangra at Tanda, Himachal Pradesh, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_219_20']
2598,31361318,"Serum magnesium, hepatocyte nuclear factor 1β genotype and post-transplant diabetes mellitus: a prospective study.","BACKGROUND


Retrospective studies suggest that tacrolimus-induced hypomagnesaemia is a risk factor for post-transplant diabetes mellitus (PTDM), but prospective studies are lacking.
METHODS


This was a prospective study with measurements of serum magnesium and tacrolimus at pre-specified time points in the first year after living donor kidney transplantation (KT). The role of single nucleotide polymorphisms (SNPs) in hepatocyte nuclear factor 1β (HNF1β) was also explored because HNF1β regulates insulin secretion and renal magnesium handling. Repeated measurement and regression analyses were used to analyse associations with PTDM.
RESULTS


In our cohort, 29 out of 167 kidney transplant recipients developed PTDM after 1 year (17%). Higher tacrolimus concentrations were significantly associated with lower serum magnesium and increased risk of hypomagnesaemia. Patients who developed PTDM had a significantly lower serum magnesium trajectory than patients who did not develop PTDM. In multivariate analysis, lower serum magnesium, age and body mass index were independent risk factors for PTDM. In recipients, the HNF1β SNP rs752010 G > A significantly increased the risk of PTDM [odds ratio (OR) = 2.56, 95% confidence interval (CI) 1.05-6.23] but not of hypomagnesaemia. This association lost significance after correction for age and sex (OR = 2.24, 95% CI 0.90-5.57). No association between HNF1β SNPs and PTDM was found in corresponding donors.
CONCLUSIONS


A lower serum magnesium in the first year after KT is an independent risk factor for PTDM. The HNF1β SNP rs752010 G > A may add to this risk through an effect on insulin secretion rather than hypomagnesaemia, but its role requires further confirmation.",2020,"This association lost significance after correction for age and sex (OR = 2.24, 95% CI 0.90-5.57).",['first year after living donor kidney transplantation (KT'],"['tacrolimus-induced hypomagnesaemia', 'single nucleotide polymorphisms (SNPs', 'serum magnesium and tacrolimus']","['serum magnesium trajectory', 'serum magnesium, age and body mass index', 'serum magnesium', 'Serum magnesium, hepatocyte nuclear factor 1β genotype and post-transplant diabetes mellitus', 'risk of hypomagnesaemia', 'Higher tacrolimus concentrations', 'PTDM', 'HNF1β SNPs and PTDM', 'risk of PTDM [odds ratio (OR) ']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0151723', 'cui_str': 'Hypomagnesemia'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum'}]","[{'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0872184', 'cui_str': 'Hepatocyte Nuclear Factors'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0151723', 'cui_str': 'Hypomagnesemia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",167.0,0.0630188,"This association lost significance after correction for age and sex (OR = 2.24, 95% CI 0.90-5.57).","[{'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'van der Burgh', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology & Transplantation, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Moes', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology & Transplantation, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Brenda C T', 'Initials': 'BCT', 'LastName': 'Kieboom', 'Affiliation': 'Department of Epidemiology, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Teun', 'Initials': 'T', 'LastName': 'van Gelder', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology & Transplantation, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zietse', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology & Transplantation, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Ron H N', 'Initials': 'RHN', 'LastName': 'van Schaik', 'Affiliation': 'Department of Clinical Chemistry, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Dennis A', 'Initials': 'DA', 'LastName': 'Hesselink', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology & Transplantation, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Ewout J', 'Initials': 'EJ', 'LastName': 'Hoorn', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology & Transplantation, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz145']
2599,32792449,Effectiveness of physical therapy in addition to occlusal splint in myogenic temporomandibular disorders: protocol of a randomised controlled trial.,"INTRODUCTION


Temporomandibular disorders (TMDs) are considered a collection of musculoskeletal conditions involving the masticatory muscles, the temporomandibular joint and associated structures. The myogenous group appears to represent the most frequently diagnosed category. In the context of a multimodal approach, splint therapy and musculoskeletal physiotherapy are often considered as a preferred therapy. The purpose of this study will be to investigate the effects of musculoskeletal physiotherapy combined with occlusal splint and education versus occlusal splint and education alone in the treatment of chronic myogenous TMD on pain and mandibular range of motion.
METHODS AND ANALYSIS


All consecutive adults complaining of TMDs presented to the Department of Biomedical and Neuromotor Sciences of the University of Bologna will be considered eligible. Inclusion criteria shall be based on the presence of myogenous TMDs, as diagnosed through clinical examination in reference to the international diagnostic criteria of TMDs. Randomisation, concealed allocation, blinded assessment and intention-to-treat analysis will be employed. The splint therapy will consist of the use of the splint every night and concurrent delivery of an educational programme; the protocol shall have a duration of three consecutive months. The combined musculoskeletal physiotherapy, splint therapy and education will additionally consist of manual therapy techniques and exercise; such protocol shall consist of a duration of three consecutive months, inclusive of 10 sessions for the enhanced elements. All outcome measures will be collected at baseline, after treatment and at a 6 months follow-up.
ETHICS AND DISSEMINATION


Ethical approval has been obtained from the Independent Ethic Committee in Clinical Research of AUSL Bologna-Italy (47/2018/SPER/AUSLBO). Pursuant to applicable rules,we will obtain informed consent from each participant and collect data anonymously to maintain privacy. Results will be disseminated to clinicians and researchers through peer-reviewed publications and conferences.
TRIAL REGISTRATION NUMBER


NCT03726060.",2020,"The purpose of this study will be to investigate the effects of musculoskeletal physiotherapy combined with occlusal splint and education versus occlusal splint and education alone in the treatment of chronic myogenous TMD on pain and mandibular range of motion.
","['myogenic temporomandibular disorders', 'All consecutive adults complaining of TMDs presented to the Department of Biomedical and Neuromotor Sciences of the University of Bologna will be considered eligible']","['musculoskeletal physiotherapy combined with occlusal splint and education versus occlusal splint and education alone', 'occlusal splint', 'physical therapy']",['pain and mandibular range of motion'],"[{'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162528', 'cui_str': 'Occlusal appliance'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]",,0.0617932,"The purpose of this study will be to investigate the effects of musculoskeletal physiotherapy combined with occlusal splint and education versus occlusal splint and education alone in the treatment of chronic myogenous TMD on pain and mandibular range of motion.
","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Incorvati', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences (DIBINEM) Oral and Maxillofacial Surgery, Alma Mater Studiorum University of Bologna, Bologna, Emilia-Romagna, Italy cristina.incorvati@unibo.it.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Romeo', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences (DIBINEM) Phisical Therapy, Alma Mater Studiorum University of Bologna, Bologna, Emilia-Romagna, Italy.'}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Fabrizi', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences (DIBINEM) Oral and Maxillofacial Surgery, Alma Mater Studiorum University of Bologna, Bologna, Emilia-Romagna, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Defila', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences (DIBINEM) Oral and Maxillofacial Surgery, Alma Mater Studiorum University of Bologna, Bologna, Emilia-Romagna, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Vanti', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences (DIBINEM) Phisical Therapy, Alma Mater Studiorum University of Bologna, Bologna, Emilia-Romagna, Italy.'}, {'ForeName': 'Maria Rosaria Antonella', 'Initials': 'MRA', 'LastName': 'Gatto', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences(DIBINEM) Medical Statistics, Alma Mater Studiorum University of Bologna, Bologna, Emilia-Romagna, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Marchetti', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences (DIBINEM) Oral and Maxillofacial Surgery, Alma Mater Studiorum University of Bologna, Bologna, Emilia-Romagna, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pillastrini', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences (DIBINEM) Phisical Therapy, Alma Mater Studiorum University of Bologna, Bologna, Emilia-Romagna, Italy.'}]",BMJ open,['10.1136/bmjopen-2020-038438']
2600,32792454,"TASCI-transcutaneous tibial nerve stimulation in patients with acute spinal cord injury to prevent neurogenic detrusor overactivity: protocol for a nationwide, randomised, sham-controlled, double-blind clinical trial.","INTRODUCTION


Neurogenic lower urinary tract dysfunction (NLUTD), including neurogenic detrusor overactivity (NDO) and detrusor sphincter dyssynergia, is one of the most frequent and devastating sequelae of spinal cord injury (SCI), as it can lead to urinary incontinence and secondary damage such as renal failure. Transcutaneous tibial nerve stimulation (TTNS) is a promising, non-invasive neuromodulatory intervention that may prevent the emergence of the C-fibre evoked bladder reflexes that are thought to cause NDO. This paper presents the protocol for TTNS in acute SCI (TASCI), which will evaluate the efficacy of TTNS in preventing NDO. Furthermore, TASCI will provide insight into the mechanisms underlying TTNS, and the course of NLUTD development after SCI.
METHODS AND ANALYSIS


TASCI is a nationwide, randomised, sham-controlled, double-blind clinical trial, conducted at all four SCI centres in Switzerland. The longitudinal design includes a baseline assessment period 5-39 days after acute SCI and follow-up assessments occurring 3, 6 and 12 months after SCI. A planned 114 participants will be randomised into verum or sham TTNS groups (1:1 ratio), stratified on study centre and lower extremity motor score. TTNS is performed for 30 min/day, 5 days/week, for 6-9 weeks starting within 40 days after SCI. The primary outcome is the occurrence of NDO jeopardising the upper urinary tract at 1 year after SCI, assessed by urodynamic investigation. Secondary outcome measures assess bladder and bowel function and symptoms, sexual function, neurological structure and function, functional independence, quality of life, as well as changes in biomarkers in the urine, blood, stool and bladder tissue. Safety of TTNS is the tertiary outcome.
ETHICS AND DISSEMINATION


TASCI is approved by the Swiss Ethics Committee for Northwest/Central Switzerland, the Swiss Ethics Committee Vaud and the Swiss Ethics Committee Zürich (#2019-00074). Findings will be disseminated through peer-reviewed publications.
TRIAL REGISTRATION NUMBER


NCT03965299.",2020,"The primary outcome is the occurrence of NDO jeopardising the upper urinary tract at 1 year after SCI, assessed by urodynamic investigation.","['A planned 114 participants', 'patients with acute spinal cord injury to prevent neurogenic detrusor overactivity']","['TASCI-transcutaneous tibial nerve stimulation', 'Transcutaneous tibial nerve stimulation (TTNS', 'TTNS', 'verum or sham TTNS']","['occurrence of NDO jeopardising the upper urinary tract at 1\u2009year after SCI, assessed by urodynamic investigation', 'bladder and bowel function and symptoms, sexual function, neurological structure and function, functional independence, quality of life, as well as changes in biomarkers in the urine, blood, stool and bladder tissue']","[{'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0341736', 'cui_str': 'Neurogenic detrusor overactivity'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0341736', 'cui_str': 'Neurogenic detrusor overactivity'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1508753', 'cui_str': 'Urinary system structure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]",114.0,0.485529,"The primary outcome is the occurrence of NDO jeopardising the upper urinary tract at 1 year after SCI, assessed by urodynamic investigation.","[{'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Birkhäuser', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Martina D', 'Initials': 'MD', 'LastName': 'Liechti', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Collene E', 'Initials': 'CE', 'LastName': 'Anderson', 'Affiliation': 'Swiss Paraplegic Research, Nottwil, Switzerland.'}, {'ForeName': 'Lucas M', 'Initials': 'LM', 'LastName': 'Bachmann', 'Affiliation': 'Medignition Inc., Research Consultants, Zürich, Switzerland.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Baumann', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baumberger', 'Affiliation': 'Spinal Cord and Rehabilitation Medicine, Swiss Paraplegic Centre, Nottwil, Switzerland.'}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Birder', 'Affiliation': 'Neuro-Urology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Sander M', 'Initials': 'SM', 'LastName': 'Botter', 'Affiliation': 'Swiss Center for Musculoskeletal Biobanking, Balgrist Campus AG, Zürich, Switzerland.'}, {'ForeName': 'Silvan', 'Initials': 'S', 'LastName': 'Büeler', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Célia D', 'Initials': 'CD', 'LastName': 'Cruz', 'Affiliation': 'Instituto de Investigação e Inovação em Saúde, Translational Neuro-urology Group, Universidade do Porto, Porto, Portugal.'}, {'ForeName': 'Gergely', 'Initials': 'G', 'LastName': 'David', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Freund', 'Affiliation': 'Spinal Cord Injury Center, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Friedl', 'Affiliation': 'Spinal Cord Injury Center, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Gross', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Margret', 'Initials': 'M', 'LastName': 'Hund-Georgiadis', 'Affiliation': 'Clinic of Neurorehabilitation and Paraplegiology, REHAB Basel, Basel, Switzerland.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Husmann', 'Affiliation': 'Swiss Center for Musculoskeletal Biobanking, Balgrist Campus AG, Zürich, Switzerland.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Jordan', 'Affiliation': 'Spinal Cord Injury Department, Clinique romande de réadaptation, Sion, Switzerland.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Koschorke', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Leitner', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Luca', 'Affiliation': 'Spinal Cord Injury Department, Clinique romande de réadaptation, Sion, Switzerland.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Mehnert', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Möhr', 'Affiliation': 'Clinic of Neurorehabilitation and Paraplegiology, REHAB Basel, Basel, Switzerland.'}, {'ForeName': 'Freschta', 'Initials': 'F', 'LastName': 'Mohammadzada', 'Affiliation': 'Spinal Cord Injury Center, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Monastyrskaya', 'Affiliation': 'Urology Research Laboratory, DBMR, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Nikolai', 'Initials': 'N', 'LastName': 'Pfender', 'Affiliation': 'Spinal Cord Injury Center, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pohl', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Hospital Zürich, Zürich, Switzerland.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Sadri', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Sartori', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schubert', 'Affiliation': 'Spinal Cord Injury Center, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Sprengel', 'Affiliation': 'Department of Trauma, University Hospital Zürich, Zürich, Switzerland.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Stalder', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Jivko', 'Initials': 'J', 'LastName': 'Stoyanov', 'Affiliation': 'Swiss Paraplegic Research, Nottwil, Switzerland.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Stress', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Tatu', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Hospital Zürich, Zürich, Switzerland.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Tawadros', 'Affiliation': 'Spinal Cord Injury Department, Clinique romande de réadaptation, Sion, Switzerland.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'van der Lely', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Wöllner', 'Affiliation': 'Neuro-Urology, Swiss Paraplegic Centre, Nottwil, Switzerland.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Zubler', 'Affiliation': 'Department of Radiology, Balgrist University Hospital, Zürich, Switzerland.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Curt', 'Affiliation': 'Spinal Cord Injury Center, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Pannek', 'Affiliation': 'Neuro-Urology, Swiss Paraplegic Centre, Nottwil, Switzerland.'}, {'ForeName': 'Martin W G', 'Initials': 'MWG', 'LastName': 'Brinkhof', 'Affiliation': 'Swiss Paraplegic Research, Nottwil, Switzerland.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Kessler', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland tkessler@gmx.ch.'}]",BMJ open,['10.1136/bmjopen-2020-039164']
2601,32792467,"Efficacy and safety of DWJ1252 compared with Gasmotin® in the treatment of functional dyspepsia: a multicenter, randomized, double-blind, active-controlled study.","Aims


Prokinetics such as mosapride citrate (Gasmotin ® ) are commonly used in functional dyspepsia (FD). This study aimed to evaluate the efficacy and safety of once-a-day DWJ1252, a sustained-release formulation of Gasmotin ® , compared with Gasmotin ®  three times a day, in patients with FD.
Methods


In this multicentre, randomized, double-blind, active-controlled, non-inferiority study, 119 patients with FD (by the Rome III criteria, 60 for DWJ1252 and 59 for Gasmotin ® ) were randomly allocated to DWJ1252 once daily or Gasmotin ®  thrice daily for 4 weeks in 16 medical institutions. Primary end point was the change in gastrointestinal symptom (GIS) score from baseline, assessed by GIS questionnaires on 5-point Likert scale after 4-week treatment. Secondary end points and safety profiles were also analysed.
Results


The study included 51 and 49 subjects in the test and control groups, respectively. GIS scores at week 4 were significantly reduced in both groups (-10.04 ± 4.45 and -10.86 ± 5.53 in the test and control groups, respectively; p<0.001), and the GIS changes from baseline did not differ between the 2 groups (difference, 0.82 point; 95% CI, -1.17, 2.81; p=0.643). Changes in GIS at weeks 2 and 4 and QoL at week 4, and the improvement rates of global assessments t weeks 2 and 4, did not differ between the groups. Adverse events were similar in the 2 groups, and there were no serious adverse events.
Conclusion


In patients with FD, DWJ1252 once daily is as effective as Gasmotin® thrice daily, with a similar safety profile.",2020,"GIS scores at week 4 were significantly reduced in both groups (-10.04 ± 4.45 and -10.86 ± 5.53 in the test and control groups, respectively; p<0.001), and the GIS changes from baseline did not differ between the 2 groups (difference, 0.82 point; 95% CI, -1.17, 2.81; p=0.643).","['51 and 49 subjects in the test and control groups, respectively', '119 patients with FD (by the Rome III criteria, 60 for DWJ1252 and 59 for Gasmotin ® ', 'functional dyspepsia', 'patients with FD']","['Gasmotin®', 'DWJ1252', 'Gasmotin ®', 'DWJ1252 once daily or Gasmotin ®', 'mosapride citrate (Gasmotin ® ']","['GIS scores', 'Adverse events', 'Efficacy and safety', 'GIS changes', 'efficacy and safety', 'Changes in GIS', 'change in gastrointestinal symptom (GIS) score from baseline, assessed by GIS questionnaires on 5-point Likert scale']","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0245956', 'cui_str': 'mosapride citrate'}]","[{'cui': 'C0815319', 'cui_str': 'Geographical Information Systems'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}]",119.0,0.385485,"GIS scores at week 4 were significantly reduced in both groups (-10.04 ± 4.45 and -10.86 ± 5.53 in the test and control groups, respectively; p<0.001), and the GIS changes from baseline did not differ between the 2 groups (difference, 0.82 point; 95% CI, -1.17, 2.81; p=0.643).","[{'ForeName': 'Jin Hwa', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Hanyang University College of Medicine.'}, {'ForeName': 'Kang Nyeong', 'Initials': 'KN', 'LastName': 'Lee', 'Affiliation': 'Hanyang University College of Medicine.'}, {'ForeName': 'Oh Young', 'Initials': 'OY', 'LastName': 'Lee', 'Affiliation': 'Hanyang University College of Medicine.'}, {'ForeName': 'Myung-Gyu', 'Initials': 'MG', 'LastName': 'Choi', 'Affiliation': 'Catholic University College of Medicine.'}, {'ForeName': 'Hyunsoo', 'Initials': 'H', 'LastName': 'Chung', 'Affiliation': 'Seoul National University College of Medicine.'}, {'ForeName': 'Suck-Chei', 'Initials': 'SC', 'LastName': 'Choi', 'Affiliation': 'Wonkwang University College of Medicine.'}, {'ForeName': 'Nayoung', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Bundang Hospital.'}, {'ForeName': 'Hyo Jin', 'Initials': 'HJ', 'LastName': 'Park', 'Affiliation': 'Yonsei University Gangnam Hospital.'}, {'ForeName': 'In-Kyung', 'Initials': 'IK', 'LastName': 'Seong', 'Affiliation': 'Konkuk University College of Medicine.'}, {'ForeName': 'Chong Il', 'Initials': 'CI', 'LastName': 'Sohn', 'Affiliation': 'Kangbuk Samsung Medical Center, Sungkyunkwan University School of Medicine.'}, {'ForeName': 'Sam Ryong', 'Initials': 'SR', 'LastName': 'Jee', 'Affiliation': 'Inje University College of Medicine.'}, {'ForeName': 'Jae Young', 'Initials': 'JY', 'LastName': 'Jang', 'Affiliation': 'Kyunghee University College of Medicine.'}, {'ForeName': 'Poong Lyul', 'Initials': 'PL', 'LastName': 'Rhee', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine.'}, {'ForeName': 'Moo In', 'Initials': 'MI', 'LastName': 'Park', 'Affiliation': 'Kosin University College of Medicine.'}, {'ForeName': 'Joong Goo', 'Initials': 'JG', 'LastName': 'Kwon', 'Affiliation': 'Catholic University of Daegu, School of Medicine.'}, {'ForeName': 'Kyung Sik', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Keimyung University College of Medicine.'}, {'ForeName': 'Kwang Jae', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': 'Ajou University College of Medicine.'}, {'ForeName': 'Joon Seong', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Soonchunhyang University College of Medicine.'}]",Journal of neurogastroenterology and motility,['10.5056/jnm20061']
2602,32797382,Implementation of Universal HIV Testing and Treatment to Reduce HIV Incidence in Botswana: the Ya Tsie Study.,"PURPOSE OF REVIEW


Antiretroviral treatment (ART) can dramatically reduce the risk of HIV transmission, but the feasibility of scaling up HIV testing, linkage and treatment to very high population levels, and its impact on population HIV incidence, were unknown. We review key findings from a community-randomized trial in which we evaluated the impact of ""universal test and treat"" (UTT) on population HIV incidence in Botswana, a resource-constrained country with both high HIV prevalence and high ART coverage before study inception.
RECENT FINDINGS


We conducted a community-randomized trial (the ""Ya Tsie"" trial or Botswana Combination Prevention Project (BCPP)) in 30 villages in Botswana from 2013 to 2018, with the goal of determining whether a combination of prevention interventions-with a focus on universal HIV testing and treatment-would reduce population-level HIV incidence. The intervention included universal HIV testing (home-based and mobile), active linkage to HIV care and treatment with patient tracing for persons not linking, universal ART coverage, rapid ART start (at the first clinic visit), and enhanced male circumcision services. Botswana had very high HIV diagnosis, treatment, and viral suppression levels (approaching the UNAIDS ""90-90-90"" targets) prior to intervention roll-out. By study end, we were able to exceed the overall 95-95-95 coverage target of 86%: an estimated 88% of all persons living with HIV were on ART and had viral suppression in the Ya Tsie intervention arm. In addition, annual HIV incidence was 30% lower in the intervention arm as compared with the control arm over a 29-month follow-up period. With universal HIV testing and relatively simple linkage activities, it was possible to achieve one of the highest reported population levels of HIV diagnosis, linkage to care, and viral suppression globally and to reduce population HIV incidence by about one-third over a short period of time (< 3 years). We were able to significantly increase population viral suppression and to decrease HIV incidence even in a resource-constrained setting with pre-existing very high testing and treatment coverage. Universal community-based HIV testing and tracing of individuals through the HIV care cascade were key intervention components.",2020,We were able to significantly increase population viral suppression and to decrease HIV incidence even in a resource-constrained setting with pre-existing very high testing and treatment coverage.,"['30 villages in Botswana from 2013 to 2018, with the goal of determining whether a combination of prevention interventions-with a focus on universal HIV testing and treatment-would reduce population-level HIV incidence', 'overall 95-95-95 coverage target of 86%: an estimated 88% of all persons living with HIV were on ART and had viral suppression in the Ya Tsie intervention arm', 'population HIV incidence in Botswana, a resource-constrained country with both high HIV prevalence and high ART coverage before study inception']","['Botswana Combination Prevention Project (BCPP', 'universal test and treat"" (UTT', 'universal HIV testing (home-based and mobile), active linkage to HIV care and treatment with patient tracing for persons not linking, universal ART coverage, rapid ART start']","['viral suppression levels', 'annual HIV incidence', 'population viral suppression']","[{'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0006041', 'cui_str': 'Botswana'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0006041', 'cui_str': 'Botswana'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442822', 'cui_str': 'Trace'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",,0.0761354,We were able to significantly increase population viral suppression and to decrease HIV incidence even in a resource-constrained setting with pre-existing very high testing and treatment coverage.,"[{'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Lockman', 'Affiliation': ""Brigham and Women's Hospital, PBB-A4, 15 Francis Street, Boston, MA, 02115, USA. slockman@hsph.harvard.edu.""}, {'ForeName': 'Molly Pretorius', 'Initials': 'MP', 'LastName': 'Holme', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Makhema', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Bachanas', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Kathleen E', 'Initials': 'KE', 'LastName': 'Wirth', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Refeletswe', 'Initials': 'R', 'LastName': 'Lebelonyane', 'Affiliation': 'Ministry of Health and Wellness, Gaborone, Botswana.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Essex', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}]",Current HIV/AIDS reports,['10.1007/s11904-020-00523-0']
2603,32797390,Comparative Efficacy of Doxycycline vs. Azithromycin in Pediatric Scrub Typhus.,,2020,,['Pediatric Scrub Typhus'],['Doxycycline vs. Azithromycin'],[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C2946035', 'cui_str': 'Scrubs'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]",[],,0.0236428,,"[{'ForeName': 'Thirunavukkarasu', 'Initials': 'T', 'LastName': 'Arun Babu', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences (AIIMS), Mangalagiri, Andhra Pradesh, 522 503, India. babuarun@yahoo.com.'}, {'ForeName': 'Dinesh Kumar', 'Initials': 'DK', 'LastName': 'Narayanasamy', 'Affiliation': 'Department of Pediatrics, JIPMER, Karaikal, Pondicherry, India.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Mathiyalagen', 'Affiliation': 'Department of Community Medicine, Indira Gandhi Medical College and Research Institute, Pondicherry, India.'}]",Indian journal of pediatrics,['10.1007/s12098-020-03469-8']
2604,32797473,"The effects of testosterone replacement therapy in men with age-dependent hypogonadism on body composition, and serum levels of leptin, adiponectin and C-reactive protein.","INTRODUCTION


Age-related hypogonadism in men leads to abnormal body composition development and inflammatory cytokines overproduction, thus has atherogenic and potentially cancer promoting effects. Design of the study was to assess the effect of age-dependent testosterone deficiency replacement in men on body composition, serum leptin, adiponectin and C-reactive protein levels.
MATERIAL/METHODS


Men aged 50-65 years (56.0±5.7, average±SD), with total testosterone levels <4 ng/mL and clinical symptoms of hypogonadism were divided into two groups of 20 men and treated with testosterone (200 mg/2 weeks intramuscularly) or placebo during 12 months.
RESULTS


12 months treatment with testosterone led to body mass index (BMI) and fat mass (FM) decrease from 26.6±2.1 to 26.1±1.8 kg/m2, P<0.05, and from 17.0±4.4 to 15.6±4.0 kg, P<0.05, respectively. BMI and FM did not change in placebo receiving subjects. Serum leptin and high-selective C-reactive protein (hsCRP) levels in testosterone group decreased from 6.2±1.4 to 4.0±1.2 μg/L, P< 0.05, and from 1.4±1.2 to 1.0±1.0 mg/L, P< 0.05 after 12 months, respectively. Adiponectin increased from 7.6±2.5μg/mL to 9.4±2.8 μg/mL, P< 0.05 in the same time. In placebo group serum leptin, adiponectin and hsCRP levels did not change significantly.
CONCLUSIONS


Testosterone replacement in men with age-related hypogonadism causes a decrease in body mass index, fat mass, serum leptin and C-reactive protein levels, and increases serum adiponectin levels.",2020,"Serum leptin and high-selective C-reactive protein (hsCRP) levels in testosterone group decreased from 6.2±1.4 to 4.0±1.2 μg/L, P< 0.05, and from 1.4±1.2 to 1.0±1.0 mg/L, P< 0.05 after 12 months, respectively.","['Men aged 50-65 years (56.0±5.7, average±SD), with total testosterone levels <4 ng/mL and clinical symptoms of hypogonadism were divided into two groups of 20 men and treated with', 'men with age-dependent hypogonadism on body composition, and serum levels of leptin, adiponectin and C-reactive protein']","['testosterone', 'testosterone deficiency replacement', 'Testosterone replacement', 'testosterone replacement therapy', 'placebo']","['body composition, serum leptin, adiponectin and C-reactive protein levels', 'body mass index, fat mass, serum leptin and C-reactive protein levels', 'serum leptin, adiponectin and hsCRP levels', 'serum adiponectin levels', 'body mass index (BMI) and fat mass (FM) decrease', 'Adiponectin', 'BMI and FM', 'Serum leptin and high-selective C-reactive protein (hsCRP) levels']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0020619', 'cui_str': 'Hypogonadism'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C1963961', 'cui_str': 'Testosterone deficiency'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",,0.0958921,"Serum leptin and high-selective C-reactive protein (hsCRP) levels in testosterone group decreased from 6.2±1.4 to 4.0±1.2 μg/L, P< 0.05, and from 1.4±1.2 to 1.0±1.0 mg/L, P< 0.05 after 12 months, respectively.","[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Dudek', 'Affiliation': ''}, {'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Kozakowski', 'Affiliation': 'jkozakowski@cmkp.edu.pl.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Zgliczyński', 'Affiliation': ''}]",Endokrynologia Polska,['10.5603/EP.a2020.0048']
2605,32797480,A Home and School Support Project for Children Excluded from Primary and First Year Secondary School.,"BACKGROUND


In the last 10 years the problem of exclusion has reached a crisis point. Research suggests that exclusion is a complex phenomenon that needs involvement from all the involved services such as Health, Education and Social Services.
METHOD


One hundred and twenty-four pupils, aged 4-12 years who, through school and social exclusion, were at risk of developing more serious mental health difficulties, were randomly allocated to standard care (n = 62) or standard care plus the new intervention (n = 62).
RESULTS


There were no significant differences in the primary outcomes between the two groups at either of the outcome assessments. However, the intervention group with non-compliance cases removed from the analysis did significantly better ( p < . 014, 95%CI -12.8 to -1.4).
CONCLUSIONS


The Home and School Support project managed to reduce the number of excluded days and the appearance of mental health symptoms for pupils who engaged fully with the intervention. The project also highlights the importance of multi-agency involvement at a very early stage.",2004,The Home and School Support project managed to reduce the number of excluded days and the appearance of mental health symptoms for pupils who engaged fully with the intervention.,"['One hundred and twenty-four pupils, aged 4-12\u2003years who, through school and social exclusion, were at risk of developing more serious mental health difficulties', 'pupils who engaged fully with the intervention', 'Children Excluded from Primary and First Year Secondary School']",['standard care (n\u2003=\u200362) or standard care plus the new intervention'],[],"[{'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0237827', 'cui_str': 'Social exclusion'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0226731,The Home and School Support project managed to reduce the number of excluded days and the appearance of mental health symptoms for pupils who engaged fully with the intervention.,"[{'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Panayiotopoulos', 'Affiliation': 'The Manchester University, School of Psychiatry, Maths Tower, Oxford Road, Manchester M13 9PL, UK. E-mail: mdpjsmk@fs1.pc.man.ac.uk.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kerfoot', 'Affiliation': 'The Manchester University, School of Psychiatry, Maths Tower, Oxford Road, Manchester M13 9PL, UK. E-mail: mdpjsmk@fs1.pc.man.ac.uk.'}]",Child and adolescent mental health,['10.1111/j.1475-3588.2004.00091.x']
2606,32797502,Multisystemic Treatment of Antisocial Adolescents in Norway: Replication of Clinical Outcomes Outside of the US.,"BACKGROUND


MST is an intensive home- and community-based intervention for youths with serious antisocial behaviour and other serious clinical problems, which has been effective at reducing out-of-home placements and producing favourable long-term clinical outcomes in the US. The aims of the study were to determine the degree to which these outcomes would be replicated in Norway for youths with serious behaviour problems and to conduct a randomised trial of MST by an independent team of investigators.
METHOD


Participants were 100 seriously antisocial youths in Norway who were randomly assigned to Multisystemic Therapy (MST) or usual Child Welfare Services (CS) treatment conditions. Data were gathered from youths, parents, and teachers pre- and post-treatment.
RESULTS


MST was more effective than CS at reducing youth internalising and externalising behaviours and out-of-home placements, as well as increasing youth social competence and family satisfaction with treatment.
DISCUSSION


This is the first study of MST outside of the US and one of the first not conducted by the developers of MST. The findings replicate those obtained by MST's developers and demonstrate the generalisability of short-term MST effects beyond the US.",2004,"MST was more effective than CS at reducing youth internalising and externalising behaviours and out-of-home placements, as well as increasing youth social competence and family satisfaction with treatment.
","['Participants were 100 seriously antisocial youths in Norway who were randomly assigned to', 'youths with serious behaviour problems', 'Antisocial Adolescents in Norway']","['Multisystemic Therapy (MST) or usual Child Welfare Services (CS) treatment conditions', 'MST']",['youth social competence and family satisfaction'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0233523', 'cui_str': 'Antisocial behavior'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C3840203', 'cui_str': 'Multisystemic therapy'}, {'cui': 'C0008093', 'cui_str': 'Child Well Being'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",100.0,0.0255462,"MST was more effective than CS at reducing youth internalising and externalising behaviours and out-of-home placements, as well as increasing youth social competence and family satisfaction with treatment.
","[{'ForeName': 'Terje', 'Initials': 'T', 'LastName': 'Ogden', 'Affiliation': 'The Norwegian Center for Studies on Conduct Problems and Innovative Practice, Oslo, Norway, E-mail: terjeo@psykologi.uio.no.'}, {'ForeName': 'Colleen A', 'Initials': 'CA', 'LastName': 'Halliday-Boykins', 'Affiliation': 'Family Services Research Center, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, USA, E-mail: hallidca@musc.edu.'}]",Child and adolescent mental health,['10.1111/j.1475-3588.2004.00085.x']
2607,32797585,Balancing Work and Family: A Controlled Evaluation of the Triple P- Positive Parenting Program as a Work-Site Intervention.,"BACKGROUND


Despite a wealth of evidence showing that behavioural family intervention is an effective intervention for parents of children with behavioural and emotional problems, little attention has been given to the relationship between parents functioning at work and their capacity to manage parenting and other home responsibilities. This study evaluated the effects of a group version of the Triple-P Positive Parenting Program (WPTP) designed specifically for delivery in the workplace.
METHOD


Participants were 42 general and academic staff from a major metropolitan university who were reporting difficulties managing home and work responsibilities and behavioural difficulties with their children. Participants were randomly assigned to WPTP, or to a waitlist control (WL) condition.
RESULTS


Following intervention, parents in WPTP reported significantly lower levels of disruptive child behaviour, dysfunctional parenting practices, and higher levels of parental self-efficacy in managing both home and work responsibilities, than parents in the WL condition. These short-term improvements were maintained at 4-months follow-up. There were also additional improvements in reported levels of work stress and parental distress at follow-up in the WPTP group compared to post-intervention.
CONCLUSIONS


Implications for the development of 'family-friendly' work environments and the prevention of child behaviour problems are discussed.",2003,"There were also additional improvements in reported levels of work stress and parental distress at follow-up in the WPTP group compared to post-intervention.
","['parents of children with behavioural and emotional problems', 'Balancing Work and Family', 'Participants were 42 general and academic staff from a major metropolitan university who were reporting difficulties managing home and work responsibilities and behavioural difficulties with their children']","['WPTP', 'Triple P', 'Triple-P Positive Parenting Program (WPTP', 'WPTP, or to a waitlist control (WL) condition']","['disruptive child behaviour, dysfunctional parenting practices, and higher levels of parental self-efficacy', 'levels of work stress and parental distress']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}]","[{'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C4040683', 'cui_str': 'Triple P - Positive Parenting Program'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",42.0,0.037755,"There were also additional improvements in reported levels of work stress and parental distress at follow-up in the WPTP group compared to post-intervention.
","[{'ForeName': 'Alicia J', 'Initials': 'AJ', 'LastName': 'Martin', 'Affiliation': 'Parenting and Family Support Centre, The University of Queensland, Brisbane 4072, Australia. E-mail: m.sanders@psy.uq.edu.au.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Sanders', 'Affiliation': 'Parenting and Family Support Centre, The University of Queensland, Brisbane 4072, Australia. E-mail: m.sanders@psy.uq.edu.au.'}]",Child and adolescent mental health,['10.1111/1475-3588.00066']
2608,32797700,The effect of an ultrasound-activated needle tip tracker needle on the performance of sciatic nerve block on a soft embalmed Thiel cadaver.,"In this study, we measured the performance of medical students and anaesthetists using a new tracker needle during simulated sciatic nerve block on soft embalmed cadavers. The tracker needle incorporates a piezo element near its tip that generates an electrical signal in response to insonation. A circle, superimposed on the ultrasound image surrounding the needle tip, changes size and colour according to the position of the piezo element within the ultrasound beam. Our primary objective was to compare sciatic block performance with the tracker switched on and off. Our secondary objectives were to record psychometrics, procedure efficiency, participant self-regulation and focused attention using eye-tracking technology. Our primary outcome measures were the number of steps successfully performed and the number of errors committed during each block. Videos were scored by trained experts using validated checklists. Sequential tracker activation and deactivation was randomised equally within subjects. With needle activation, steps improved in 10 (25%) subjects and errors reduced in six (15%) subjects. The most important steps were: needle tip identification before injection, OR (95%CI) 2.12 (1.61-2.80; p < 0.001); and needle tip identification before advance of the needle, 1.80 (1.36-2.39; p < 0.001). The most important errors were: failure to identify the needle tip before injection, 2.40 (1.78-3.24; p < 0.001); and failure to quickly regain needle tip position when tip visibility was lost, 2.03 (1.5-2.75; p < 0.001). In conclusion, needle-tracking technology improved performance in a quarter of subjects.",2020,"With needle activation, steps improved in 10 (25%) subjects and errors reduced in six (15%) subjects.",['medical students and anaesthetists using a new tracker needle during simulated sciatic nerve block on soft embalmed cadavers'],['ultrasound-activated needle tip tracker needle'],"['record psychometrics, procedure efficiency, participant self-regulation and focused attention using eye-tracking technology', 'number of steps successfully performed and the number of errors committed during each block', 'sciatic block performance']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0394735', 'cui_str': 'Injection of anesthetic agent into sciatic nerve'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0006629', 'cui_str': 'Cadaver'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}]","[{'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0589098', 'cui_str': 'Focused attention'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]",,0.0268927,"With needle activation, steps improved in 10 (25%) subjects and errors reduced in six (15%) subjects.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'McKendrick', 'Affiliation': 'Department of Psychology, Heriot-Watt University, Edinburgh, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sadler', 'Affiliation': 'Ninewells Hospital, Dundee, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Taylor', 'Affiliation': 'Ninewells Hospital, Dundee, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Seeley', 'Affiliation': 'Ninewells Hospital, Dundee, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Filipescu', 'Affiliation': 'Ninewells Hospital, Dundee, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mustafa', 'Affiliation': 'Ninewells Hospital, Dundee, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'McKendrick', 'Affiliation': 'Optomize Ltd, Glasgow, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Halcrow', 'Affiliation': 'Ninewells Hospital, Dundee, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Raju', 'Affiliation': 'Ninewells Hospital, Dundee, UK.'}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'McLeod', 'Affiliation': 'Ninewells Hospital, Dundee, UK.'}]",Anaesthesia,['10.1111/anae.15211']
2609,32796392,Adjunctive Raloxifene and Isradipine Improve Cognitive Functioning in Patients With Schizophrenia: A Pilot Study.,"BACKGROUND


Cognitive impairment is the most important feature of schizophrenia leading to severe functional disability. To identify pathways that improve pathophysiological neurocognition in schizophrenia is a current challenge for the development of goal-directed clinical interventions. In the present study, we investigated the effects of raloxifene (a selective estrogen modulator) and isradipine (a voltage-gated L-type calcium channel blocker) on cognitive deficits in patients with schizophrenia.
METHOD


We designed a double-blind, randomized, parallel, placebo-controlled trial. We randomized 60 patients with schizophrenia into 3 groups including isradipine 5 mg, raloxifine 60 mg, and placebo for 6 consequent weeks, all in the same shape capsules, 2 times a day, along with treatment as usual. The initial and final results of blood tests, electrocardiograms, and cognitive tests in specific domains, such as attention, processing speed, executive function, and verbal memory were evaluated.
RESULTS


Our findings revealed a remarkable association between adjunctive raloxifene treatment and the alleviation of verbal memory deficits. Isradipine treatment significantly improved the verbal memory and attention dysfunction in some variables of the Stroop test, compared with the placebo. However, no effect was observed in processing speed and executive function deficits.
CONCLUSIONS


To the best of our knowledge, this study provides the first evidence that isradipine is a novel therapy option improving verbal memory and attention, both related to its activity in the hippocampus and the cerebellum. Further investigations are necessary to elucidate the mechanisms of action for both drugs in schizophrenia.",2020,"Isradipine treatment significantly improved the verbal memory and attention dysfunction in some variables of the Stroop test, compared with the placebo.","['Patients With Schizophrenia', '60 patients with schizophrenia into 3 groups including', 'patients with schizophrenia']","['Isradipine', 'Adjunctive Raloxifene and Isradipine', 'isradipine', 'isradipine (a voltage-gated L-type calcium channel blocker', 'isradipine 5 mg, raloxifine 60 mg, and placebo', 'raloxifene', 'placebo']","['blood tests, electrocardiograms, and cognitive tests in specific domains, such as attention, processing speed, executive function, and verbal memory', 'Cognitive Functioning', 'verbal memory and attention dysfunction', 'alleviation of verbal memory deficits', 'processing speed and executive function deficits', 'cognitive deficits']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0071304', 'cui_str': 'Isradipine'}, {'cui': 'C0244404', 'cui_str': 'Raloxifene'}, {'cui': 'C0237633', 'cui_str': 'Sensory Filtering'}, {'cui': 'C0288263', 'cui_str': 'L-Type Calcium Channels'}, {'cui': 'C0987008', 'cui_str': 'Isradipine 5 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}]",60.0,0.0752954,"Isradipine treatment significantly improved the verbal memory and attention dysfunction in some variables of the Stroop test, compared with the placebo.","[{'ForeName': 'Bita', 'Initials': 'B', 'LastName': 'Vahdani', 'Affiliation': 'From the Department of Psychiatry, Bahamn Hospital, Qazvin University of Medical Sciences, Qazvin.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Armani Kian', 'Affiliation': 'Department of Psychiatry, Beheshti Hospital.'}, {'ForeName': 'Abdolreza', 'Initials': 'A', 'LastName': 'Esmaeilzadeh', 'Affiliation': 'Department of Immunology.'}, {'ForeName': 'Saeedeh', 'Initials': 'S', 'LastName': 'Zenoozian', 'Affiliation': 'Department of Clinical Psychology, Beheshti Hospital.'}, {'ForeName': 'Vida', 'Initials': 'V', 'LastName': 'Yousefi', 'Affiliation': 'Department of Clinical Psychology, Beheshti Hospital.'}, {'ForeName': 'Saeideh', 'Initials': 'S', 'LastName': 'Mazloomzadeh', 'Affiliation': 'Social Determinants of Health Research Center, Zanjan University of Medical Sciences, Zanjan, Iran.'}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001274']
2610,32796391,Anti-inflammatory Combination Therapy for the Treatment of Schizophrenia.,"BACKGROUND


Despite adequate antipsychotic treatment, most people with schizophrenia continue to exhibit persistent positive and negative symptoms and cognitive impairments. The current study was designed to examine the efficacy and safety of adjunctive anti-inflammatory combination therapy for these illness manifestations.
METHODS


Thirty-nine people with either Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, schizophrenia or schizoaffective disorder were entered into a 12-week double-blind, 2-arm, triple-dummy, placebo-controlled, randomized clinical trial: 19 were randomized to anti-inflammatory combination therapy and 20 were randomized to placebo. The Brief Psychiatric Rating Scale positive symptom item total score was used to assess positive symptom change, the Scale for the Assessment of Negative Symptoms total score was used to assess negative symptom change, the Calgary Depression Scale total score was used to assess depressive symptom change, and the MATRICS Consensus Cognitive Battery was used to assess neuropsychological test performance.
RESULTS


There was a significant time effect for Brief Psychiatric Rating Scale positive symptom item score (t226 = -2.66, P = 0.008), but the treatment (t54=1.52, P = 0.13) and treatment × time (t223 = 0.47, P = 0.64) effects were not significant. There were no significant time (t144 = 0.53, P = 0.72), treatment (t58=0.48, P = 0.63), or treatment × time (t143 = -0.20, P = 0.84) effects for the Scale for the Assessment of Negative Symptoms total score; or for any of the other symptom measures. There were no significant group differences in the change in the MATRICS Consensus Cognitive Battery composite score over the course of the study (F1,26=2.20, P = 0.15).
CONCLUSIONS


The study results suggest that there is no significant benefit of combined anti-inflammatory treatment for persistent positive symptoms or negative symptoms or cognitive impairments (clinicaltrials.gov trial number: NCT01514682).",2020,"There was a significant time effect for Brief Psychiatric Rating Scale positive symptom item score (t226 = -2.66, P = 0.008), but the treatment (t54=1.52, P = 0.13) and treatment × time (t223 = 0.47, P = 0.64) effects were not significant.","['Thirty-nine people with either Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, schizophrenia or schizoaffective disorder']","['adjunctive anti-inflammatory combination therapy', 'anti-inflammatory combination therapy', 'placebo']","['Brief Psychiatric Rating Scale positive symptom item score', 'Consensus Cognitive Battery composite score', 'negative symptom change, the Calgary Depression Scale total score', 'Brief Psychiatric Rating Scale positive symptom item total score', 'efficacy and safety', 'neuropsychological test performance']","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0441797', 'cui_str': 'Fourth edition'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}]","[{'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0029941', 'cui_str': 'Brief psychiatric rating scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}]",19.0,0.122251,"There was a significant time effect for Brief Psychiatric Rating Scale positive symptom item score (t226 = -2.66, P = 0.008), but the treatment (t54=1.52, P = 0.13) and treatment × time (t223 = 0.47, P = 0.64) effects were not significant.","[{'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Buchanan', 'Affiliation': 'From the Maryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Weiner', 'Affiliation': ''}, {'ForeName': 'Deanna L', 'Initials': 'DL', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Gold', 'Affiliation': ''}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Zaranski', 'Affiliation': ''}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Blatt', 'Affiliation': ''}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Wehring', 'Affiliation': ''}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Carpenter', 'Affiliation': ''}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001253']
2611,32796442,Microstructural Changes in Cystoid Macular Edema in Retinitis Pigmentosa after Intravitreal Dexamethasone Implant Injection.,"PURPOSE


To evaluate microstructural changes in cystoid macular edema (CME) in retinitis pigmentosa (RP) after intravitreal dexamethasone implant injection.
METHODS


In an extended cohort of a randomized trial of intravitreal dexamethasone implant for the management of RP-CME, microstructural changes during six months after treatment were evaluated using spectral domain optical coherence tomography.
RESULTS


Forty-two eyes were included, and all had cystoid space in the inner nuclear layer (INL) at baseline. No eyes showed subretinal fluid, and 28.6% showed hyperreflective foci. Among 38 eyes with cystoid space both in the INL and outer nuclear layer/Henle's layer (ONL/HL), 13 (34.2%) showed complete resolution and 12 (31.6%) showed cystoid space only in the INL at 2 months after injection, while others showed persistent cystoid space in both layers. After complete resolution, cystoid space recurrence was earlier in the INL than in the ONL/HL. Multivariable analysis showed that greater cystoid space area in the INL and ONL/HL, presence of macular leakage, and longer intact external limiting membrane at baseline were associated with greater cystoid space area decrease after treatment.
CONCLUSION


Resolution and recurrence pattern of RP-CME after dexamethasone treatment showed that the INL is the primary layer of cystic change, and this suggests its pathogenesis is most likely due to Müller cell dysfunction.",2020,"After complete resolution, cystoid space recurrence was earlier in the INL than in the ONL/HL.","['cystoid macular edema (CME) in retinitis pigmentosa (RP', 'Forty-two eyes were included, and all had cystoid space in the inner nuclear layer (INL) at baseline', 'Cystoid Macular Edema in Retinitis Pigmentosa after Intravitreal Dexamethasone Implant Injection']","['dexamethasone', 'intravitreal dexamethasone']","['hyperreflective foci', 'subretinal fluid', 'cystoid space recurrence', 'complete resolution', 'cystoid space']","[{'cui': 'C0024440', 'cui_str': 'Cystoid macular edema'}, {'cui': 'C0035334', 'cui_str': 'Retinitis pigmentosa'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}]","[{'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",42.0,0.0344495,"After complete resolution, cystoid space recurrence was earlier in the INL than in the ONL/HL.","[{'ForeName': 'Un Chul', 'Initials': 'UC', 'LastName': 'Park', 'Affiliation': 'Department of Ophthalmology, College of Medicine, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Jung Hyun', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Ophthalmology, College of Medicine, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Chang Ki', 'Initials': 'CK', 'LastName': 'Yoon', 'Affiliation': 'Department of Ophthalmology, College of Medicine, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Hyeong Gon', 'Initials': 'HG', 'LastName': 'Yu', 'Affiliation': 'Department of Ophthalmology, College of Medicine, Seoul National University, Seoul, Korea.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002944']
2612,32796456,INYBI: A New Tool for Self-Myofascial Release of the Suboccipital Muscles in Patients with Chronic Non-Specific Neck Pain: A Randomized Controlled Trial.,"STUDY DESIGN


A randomized, single-blinded (the outcome assessor was unaware of participants' allocation group) controlled clinical trial.
OBJECTIVE


To investigate the effects of myofascial release therapy (MRT) over the suboccipital muscles, compared with self-MRT using a novel device, the INYBI tool, on pain-related outcomes, active cervical mobility, and vertical mouth opening, in adults with chronic non-specific neck pain (NSNP).
SUMMARY OF BACKGROUND DATA


MRT is used to manage chronic musculoskeletal pain conditions, with purported positive effects. The efficacy of self-MRT, compared to MRT, has been scarcely evaluated.
METHODS


Fifty-eight participants (mean age of 34.6 ± 4.7 years; range 21-40 years; 77.6% females, 22.4% males) with persistent NSNP agreed to participate, and were equally distributed into an INYBI (n = 29) or a control group (n = 29). Both groups underwent a single 5-minutes intervention session. For participants in the control group, MRT of the suboccipital muscles was performed using the suboccipital muscle inhibition technique, while those in the INYBI group underwent a self-MRT intervention using the INYBI device. Primary measurements were taken of pain intensity (Visual Analogue Scale), local pressure pain sensitivity, as assessed with an algometer, and active cervical range-of-movement. Secondary outcomes included pain-free vertical mouth opening. Outcomes were collected at baseline, immediately after intervention and 45 minutes later.
RESULTS


The ANOVAs demonstrated no significant between-groups effect for any variable (all, p > 0.05). In the within-groups comparison, all participants significantly improved pain-related outcomes, and showed similar positive changes for mouth opening. Cervical range-of-movement- mainly increased after intervention for participants in the control group.
CONCLUSION


Both, MRT and self-MRT using the INYBI, are equally effective to enhance self-reported pain intensity, and local pressure pain sensitivity in chronic NSNP patients. For cervical mobility, MRT appears to be slighlty superior, compared to the INYBI, to achieve improvements in this population.
LEVEL OF EVIDENCE


2.",2020,"Cervical range-of-movement- mainly increased after intervention for participants in the control group.
","['adults with chronic non-specific neck pain (NSNP', 'Patients with Chronic Non-Specific Neck Pain', 'participants in the control group', 'chronic NSNP patients', 'Fifty-eight participants (mean age of 34.6\u200a±\u200a4.7 years; range 21-40 years; 77.6% females, 22.4% males) with persistent NSNP agreed to participate, and were equally distributed into an INYBI (n\u200a=\u200a29) or a control group (n\u200a=\u200a29']","['INYBI', 'self-MRT', 'myofascial release therapy (MRT', 'self-MRT intervention']","['Cervical range-of-movement- mainly', 'pain-free vertical mouth opening', 'pain-related outcomes', 'pain intensity, and local pressure pain sensitivity', 'pain intensity (Visual Analogue Scale), local pressure pain sensitivity, as assessed with an algometer, and active cervical range-of-movement', 'positive changes for mouth opening']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",58.0,0.086756,"Cervical range-of-movement- mainly increased after intervention for participants in the control group.
","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Pérez-Martínez-Casero', 'Affiliation': 'Escuela de Osteopatía de Madrid, Madrid, Spain.'}, {'ForeName': 'Kristobal', 'Initials': 'K', 'LastName': 'Gogorza-Arroitaonandia', 'Affiliation': 'Escuela de Osteopatía de Madrid, Madrid, Spain.'}, {'ForeName': 'Alberto Marcos', 'Initials': 'AM', 'LastName': 'Heredia-Rizo', 'Affiliation': 'Department of Physiotherapy, Faculty of Nursing, Physiotherapy and Podiatry, University of Sevilla, Sevilla, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Salas-González', 'Affiliation': 'Department of Physiotherapy, Faculty of Nursing, Physiotherapy and Podiatry, University of Sevilla, Sevilla, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Oliva-Pascual-Vaca', 'Affiliation': 'Department of Physiotherapy, Faculty of Nursing, Physiotherapy and Podiatry, University of Sevilla, Sevilla, Spain.'}]",Spine,['10.1097/BRS.0000000000003605']
2613,32796502,Effects of a Physical Activity Program Potentiated with ICTs on the Formation and Dissolution of Friendship Networks of Children in a Middle-Income Country.,"This paper assesses the potential cohesion effect of a physical activity (PA) school-based intervention potentiated using text messages (SMS) through analyzing longitudinally the friendship network structure and the mechanisms of the formation and dissolution of friendships. Three schools ( n  = 125 participants) in Bogotá, Colombia, were randomly assigned into three groups: Modulo Activo Recreo Activo (MARA) + SMS (networks 1 and 2), MARA (networks 3 and 4), and control (no intervention: networks 5-7). We collected socio-economic, health-related, network structure, and intervention satisfaction variables in the baseline and after 10 weeks on July-November 2013. For each classroom network, we conducted four models using a temporal and static network approach to assess (1) temporal social network changes, (2) friendship homophily, (3) friendship formation and dissolution mechanisms, and (4) effect of SMS on the networks' cohesion. We found that (1) social cohesion emerged in the four intervened networks that were measured over time with transitivity and homophily driven by clustering, (2) the intervention affected the mechanisms of friendship formation and dissolution, and (3) MARA + SMS on average created more social cohesion and 3.8 more friendships than the program alone. Potentially, school-based interventions with information and communication technologies (ICT) such as MARA + SMS could encourage social cohesion among children. The particular characteristics of each school network need to be considered when developing school-based interventions.",2020,"We found that (1) social cohesion emerged in the four intervened networks that were measured over time with transitivity and homophily driven by clustering, (2) the intervention affected the mechanisms of friendship formation and dissolution, and (3) MARA + SMS on average created more social cohesion and 3.8 more friendships than the program alone.","['Children in a Middle-Income Country', 'Three schools ( n  = 125 participants) in Bogotá, Colombia', 'children']","['Modulo Activo Recreo Activo (MARA) + SMS (networks 1 and 2), MARA (networks 3 and 4), and control (no intervention: networks 5-7', 'physical activity (PA) school-based intervention potentiated using text messages (SMS', 'information and communication technologies (ICT) such as MARA + SMS', 'Physical Activity Program Potentiated with ICTs']",['Formation and Dissolution of Friendship Networks'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}]","[{'cui': 'C0445579', 'cui_str': 'Recreo'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0324975', 'cui_str': 'Dolichotis patagonum'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0683867', 'cui_str': 'Information Technology'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]",,0.0241644,"We found that (1) social cohesion emerged in the four intervened networks that were measured over time with transitivity and homophily driven by clustering, (2) the intervention affected the mechanisms of friendship formation and dissolution, and (3) MARA + SMS on average created more social cohesion and 3.8 more friendships than the program alone.","[{'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Guerra', 'Affiliation': 'Department of Industrial Engineering, Universidad de Los Andes, Bogotá 111711, Colombia.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Montes', 'Affiliation': 'Department of Industrial Engineering, Universidad de Los Andes, Bogotá 111711, Colombia.'}, {'ForeName': 'Andrés F', 'Initials': 'AF', 'LastName': 'Useche', 'Affiliation': 'Department of Industrial Engineering, Universidad de Los Andes, Bogotá 111711, Colombia.'}, {'ForeName': 'Ana María', 'Initials': 'AM', 'LastName': 'Jaramillo', 'Affiliation': 'Department of Industrial Engineering, Universidad de Los Andes, Bogotá 111711, Colombia.'}, {'ForeName': 'Silvia A', 'Initials': 'SA', 'LastName': 'González', 'Affiliation': ""Healthy Active Living and Obesity Research Group, Children's Hospital of Eastern Ontario Research Institute, Ottawa, ON K1H 8L1, Canada.""}, {'ForeName': 'Jose D', 'Initials': 'JD', 'LastName': 'Meisel', 'Affiliation': 'Social and Health Complexity Center, Universidad de Los Andes, Bogotá 111711, Colombia.'}, {'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Obando', 'Affiliation': 'INRIA, Institut du Cerveau et de la Moelle épinière, ICM, Inserm U 1127, CNRS UMR 7225, Sorbonne Université, 75013 Paris, France.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Cardozo', 'Affiliation': 'Department of Industrial Engineering, Universidad de Los Andes, Bogotá 111711, Colombia.'}, {'ForeName': 'Ruth F', 'Initials': 'RF', 'LastName': 'Hunter', 'Affiliation': ""Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast BT7 1NN, UK.""}, {'ForeName': 'Olga L', 'Initials': 'OL', 'LastName': 'Sarmiento', 'Affiliation': 'School of Medicine, Universidad de los Andes, Bogotá 111711, Colombia.'}]",International journal of environmental research and public health,['10.3390/ijerph17165796']
2614,32796597,High Throughput Molecular Characterization of Normal Karyotype Acute Myeloid Leukemia in the Context of the Prospective Trial 02/06 of the Northern Italy Leukemia Group (NILG).,"By way of a Next-Generation Sequencing NGS high throughput approach, we defined the mutational profile in a cohort of 221 normal karyotype acute myeloid leukemia (NK-AML) enrolled into a prospective randomized clinical trial, designed to evaluate an intensified chemotherapy program for remission induction.  NPM1 ,  DNMT3A,  and  FLT3 -ITD were the most frequently mutated genes while  DNMT3A ,  FLT3 ,  IDH1 ,  PTPN11 , and  RAD21  mutations were more common in the  NPM1  mutated patients ( p  < 0.05).  IDH1  R132H mutation was strictly associated with  NPM1  mutation and mutually exclusive with  RUNX1  and  ASXL1 . In the whole cohort of NK-AML, no matter the induction chemotherapy used, by multivariate analysis, the achievement of complete remission was negatively affected by the  SRSF2  mutation. Alterations of  FLT3  ( FLT3- ITD) and  U2AF1  were associated with a worse overall and disease-free survival ( p  < 0.05).  FLT3- ITD positive patients who proceeded to alloHSCT had a survival probability similar to  FLT3- ITD negative patients and the transplant outcome was no different when comparing high and low-AR- FLT3 -ITD subgroups in terms of both OS and DFS. In conclusion, a comprehensive molecular profile for NK-AML allows for the identification of genetic lesions associated to different clinical outcomes and the selection of the most appropriate and effective treatment strategies, including stem cell transplantation and targeted therapies.",2020,Alterations of  FLT3  ( FLT3- ITD) and  U2AF1  were associated with a worse overall and disease-free survival ( p  < 0.05).  ,"['221 normal karyotype acute myeloid leukemia (NK-AML', 'Northern Italy Leukemia Group (NILG']",['FLT3'],"['complete remission', 'NPM1 ,  DNMT3A,  and  FLT3 -ITD', 'IDH1', 'Alterations of  FLT3  ( FLT3- ITD', 'survival probability', 'overall and disease-free survival']","[{'cui': 'C3839868', 'cui_str': 'Cytogenetically normal acute myeloid leukemia'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0251006', 'cui_str': 'FLT3 protein, human'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0069141', 'cui_str': 'nucleophosmin'}, {'cui': 'C0251006', 'cui_str': 'FLT3 protein, human'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",221.0,0.0620904,Alterations of  FLT3  ( FLT3- ITD) and  U2AF1  were associated with a worse overall and disease-free survival ( p  < 0.05).  ,"[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Salmoiraghi', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Cavagna', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Zanghì', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Pavoni', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Michelato', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}, {'ForeName': 'Ksenija', 'Initials': 'K', 'LastName': 'Buklijas', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Elidi', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Intermesoli', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Lussana', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Oldani', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Caprioli', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Stefanoni', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Gianfaldoni', 'Affiliation': 'Hematology Unit, Azienda Ospedaliera Universitaria Careggi, 50134 Firenze, Italy.'}, {'ForeName': 'Ernesta', 'Initials': 'E', 'LastName': 'Audisio', 'Affiliation': 'Hematology Unit A.O.U. Città della Salute e della Scienza di Torino, 10126 Torino, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Terruzzi', 'Affiliation': 'Hematology Unit, Azienda Ospedaliera San Gerardo, 20900 Monza, Italy.'}, {'ForeName': 'Lorella', 'Initials': 'L', 'LastName': 'De Paoli', 'Affiliation': 'Hematology Unit, Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo, 15121 Alessandria, Italy.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Borlenghi', 'Affiliation': 'Hematology Unit, ASST-Spedali Civili, 25123, Brescia, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cavattoni', 'Affiliation': 'Hematology Unit, Ospedale S. Maurizio, 39100 Bolzano, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Mattei', 'Affiliation': 'Hematology Unit, Azienda Ospedaliera S.Croce e Carle di Cuneo, 12100 Cuneo, Italy.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Scattolin', 'Affiliation': ""Hematology Unit, Ospedale dell'Angelo and SS. Giovanni e Paolo, 30174 Venezia Mestre, Italy.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Tajana', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST) Ospedale di Cremona, 26100 Cremona, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Ciceri', 'Affiliation': 'Hematology Unit, IRCSS Ospedale San Raffaele, 20132 Milano, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Todisco', 'Affiliation': 'Hematology Unit, IRCCS Istituto Clinico Humanitas di Rozzano, 20089 Rozzano (MI), Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Campiotti', 'Affiliation': 'Medicine and Surgery Department, University of Insubria, 21100 Varese, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Corradini', 'Affiliation': 'Hematology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 Milano, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Fracchiolla', 'Affiliation': ""Hematology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122 Milano, Italy.""}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Bassan', 'Affiliation': ""Hematology Unit, Ospedale dell'Angelo and SS. Giovanni e Paolo, 30174 Venezia Mestre, Italy.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Rambaldi', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}, {'ForeName': 'Orietta', 'Initials': 'O', 'LastName': 'Spinelli', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}]",Cancers,['10.3390/cancers12082242']
2615,32796401,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Saccharomyces boulardii in Infants and Children With Acute Diarrhea.","AIM


This study was designed to assess the efficacy and safety of Saccharomyces cerevisiae variant boulardii CNCM I-3799 (S. boulardii CNCM I-3799) in the management of acute diarrhea in children.
METHODS


A total of 100 infants and children aged 3-36 months with acute diarrhea received medical care according to the World Health Organization guidelines on the management of acute diarrhea in children and were randomly allocated to the probiotic group (S. boulardii CNCM I-3799 at a daily dose of 5 billion CFU twice daily) or to the placebo group. Infants and children were treated for 5 days and an extended follow-up was planned 1 and 2 months after the end of the treatment period. Primary endpoint was the time of recovery from diarrhea defined as the duration of diarrhea. Other parameters, such as frequency and consistency of stools, associated with the severity of diarrhea episodes were defined as secondary endpoints.
RESULTS


The administration of S. boulardii CNCM I-3799 was associated with beneficial effects on duration and severity of diarrhea. The time of recovery from diarrhea was significantly shorter in the probiotic group compared with the placebo group (65.8 ± 12 hours vs. 95.3 ± 17.6 hours, P = 0.0001). Faster remission in the probiotic group was also demonstrated by a shorter time before the first episode of semisolid stool [-23.5 hours, diff (95% CI): -7.99 (-31.49 to -15.51), P = 0.0001] and the faster normalization of stool consistency. S. boulardii CNCM I-3799 was well tolerated.
CONCLUSION


S. boulardii CNCM I-3799 supplementation in children with acute diarrhea was shown effective in reducing the duration and severity of diarrhea in infants and children.",2020,The administration of S. boulardii CNCM I-3799 was associated with beneficial effects on duration and severity of diarrhea.,"['Infants and Children With Acute Diarrhea', '100 infants and children aged 3-36 months with acute diarrhea received medical care according to the World Health Organization guidelines on the management of acute diarrhea in children', 'acute diarrhea in children', 'children with acute diarrhea']","['Saccharomyces boulardii', 'Placebo', 'S. boulardii CNCM I-3799 supplementation', 'Saccharomyces cerevisiae variant boulardii CNCM I-3799 (S. boulardii CNCM I-3799', 'probiotic group (S. boulardii CNCM I-3799', 'placebo']","['faster normalization of stool consistency', 'time of recovery from diarrhea defined as the duration of diarrhea', 'severity of diarrhea episodes', 'tolerated', 'frequency and consistency of stools', 'time of recovery from diarrhea', 'Faster remission', 'duration and severity of diarrhea']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0772093', 'cui_str': 'Saccharomyces boulardii'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0036025', 'cui_str': 'Saccharomyces cerevisiae'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",100.0,0.251802,The administration of S. boulardii CNCM I-3799 was associated with beneficial effects on duration and severity of diarrhea.,"[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Mourey', 'Affiliation': 'From the Research & Applications, Gnosis by Lesaffre, Lesaffre International, Marcq-en-Barœul, France.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Sureja', 'Affiliation': 'Sundyota Numandis Probioceuticals Pvt. Ltd.'}, {'ForeName': 'Dharmeshkumar', 'Initials': 'D', 'LastName': 'Kheni', 'Affiliation': 'Sundyota Numandis Probioceuticals Pvt. Ltd.'}, {'ForeName': 'Parthiv', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Hitarth Children Hospital.'}, {'ForeName': 'Devang', 'Initials': 'D', 'LastName': 'Parikh', 'Affiliation': 'Bakeri Medical Research Centre.'}, {'ForeName': 'Unmesh', 'Initials': 'U', 'LastName': 'Upadhyay', 'Affiliation': 'Iqra Hospital.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Satia', 'Affiliation': 'Ethicare Clinical Trial Services, Ahmedabad, India.'}, {'ForeName': 'Dhara', 'Initials': 'D', 'LastName': 'Shah', 'Affiliation': 'Ethicare Clinical Trial Services, Ahmedabad, India.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Troise', 'Affiliation': 'From the Research & Applications, Gnosis by Lesaffre, Lesaffre International, Marcq-en-Barœul, France.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Decherf', 'Affiliation': 'From the Research & Applications, Gnosis by Lesaffre, Lesaffre International, Marcq-en-Barœul, France.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002849']
2616,32796410,Long-Term Efficacy of Treatment Effects After a Kyphosis Exercise and Posture Training Intervention in Older Community-Dwelling Adults: A Cohort Study.,"BACKGROUND AND PURPOSE


Treatments that prevent worsening kyphosis are important due to the progressive nature of kyphosis with aging. We assessed long-term efficacy of treatment effects after a short-term kyphosis exercise and posture training intervention in a cohort study among older adults with hyperkyphosis, and investigated whether long-term treatment effects differ among males and females.
METHODS


In the original kyphosis intervention, 112 older adults enrolled in a waitlist design randomized controlled trial. One hundred three participants, mean age 70.0 (5.7) years and kyphosis 52.0° (7.4°), completed a twice weekly, 3-month, group exercise and posture training intervention, and were eligible to enroll in the follow-up study. We compared (1) change in outcomes pre-/postintervention to change postintervention over the follow-up period, (2) change in outcomes pre-/postintervention and postintervention to follow-up, stratified by sex, and (3) long-term change postintervention to follow-up in males and females. Primary outcome was change in kyphometer-measured thoracic kyphosis. Secondary outcomes were change in lumbar lordosis, objective measures of physical function, self-reported measures of physical activity, and health-related quality of life (HRQoL).
RESULTS AND DISCUSSION


Forty-three participants, 42% of the eligible cohort, returned for follow-up, a mean 3.0 (0.7) years after completing the original intervention. Participants (27 females and 16 males) were 73.8 (6.1) years old, with mean kyphosis 48.9° (11.9°) at follow-up. Kyphosis declined -1.5° (95% confidence interval [CI]: -3.9° to 1.0°) postintervention to follow-up and this was no different than change pre-/postintervention, P = .173. Lordosis improved 8.9° (95% CI: 6.2° to 11.6°), more than change pre-/postintervention, P < .001. Gait speed measure of physical function increased 0.08 (95% CI: 0.02 to 0.14) m/s, Physical Activity Scale for the Elderly (PASE) measure of physical activity increased 4 (95% CI: -16 to 24) points, and Patient-Reported Outcomes Measurement Information System (PROMIS) mental health T-score measure of HRQoL increased 1.1 (95% CI: -1.0 to 3.1) points, but these improvements were not significantly more than change pre-/postintervention, P > .050. Other measures of physical function (modified Physical Performance Test [PPT], Timed Up and Go, and 6-minute walk) and HRQoL (Scoliosis Research Society [SRS-30] self-image and PROMIS physical function and physical health) declined at follow-up, significantly more than change pre/postintervention, P ≤ .050. Comparing change in outcomes pre-/postintervention and postintervention to follow-up, stratified by sex, both males and females increased lordosis, and decreased modified PPT and 6-minute walk measures of physical function, P < .050. Males and females differed in long-term change postintervention to follow-up. Time loaded standing and PASE improved in females compared with males, P = .008 and P = .092, respectively, and PROMIS mental health, physical health, and physical function declined in females compared with males, P = .073, P = .025, and P = .005, respectively.
CONCLUSIONS


In our follow-up study, a mean of 3.0 (0.07) years after a 3-month kyphosis exercise and posture training intervention, kyphosis maintained and did not progress as expected with age. There was long-term improvement in lordosis. Compared with treatment effects from the short-term intervention, gait speed maintained equally well in males and females, while trunk endurance improved in females. Further investigation of long-term benefits of a short-term kyphosis exercise and posture training intervention is warranted.",2020,"Time loaded standing and PASE improved in females compared with males, P = .008 and P = .092, respectively, and PROMIS mental health, physical health, and physical function declined in females compared with males, P = .073, P = .025, and P = .005, respectively.
","['Participants (27 females and 16 males) were 73.8 (6.1) years old, with mean kyphosis 48.9° (11.9°) at follow-up', 'One hundred three participants, mean age 70.0 (5.7) years and kyphosis 52.0° (7.4°', 'Forty-three participants, 42% of the eligible cohort, returned for follow-up, a mean 3.0 (0.7) years after completing the original intervention', 'Older Community-Dwelling Adults', 'older adults with hyperkyphosis', 'males and females', '112 older adults enrolled']","['Kyphosis Exercise and Posture Training Intervention', 'exercise and posture training intervention', 'short-term kyphosis exercise and posture training intervention']","['gait speed maintained equally well in males and females, while trunk endurance', 'PROMIS mental health, physical health, and physical function', 'Time loaded standing and PASE', 'Physical Activity Scale for the Elderly (PASE) measure of physical activity', 'Lordosis', 'modified PPT and 6-minute walk measures of physical function', 'mental health T-score measure of HRQoL', 'physical function (modified Physical Performance Test [PPT], Timed Up and Go, and 6-minute walk) and HRQoL (Scoliosis Research Society [SRS-30] self-image and PROMIS physical function and physical health', 'lordosis', 'change in kyphometer-measured thoracic kyphosis', 'change in lumbar lordosis, objective measures of physical function, self-reported measures of physical activity, and health-related quality of life (HRQoL', 'Gait speed measure of physical function', 'Outcomes Measurement Information System (PROMIS']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0454282', 'cui_str': 'Posture training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024003', 'cui_str': 'Lordosis accentuated'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036439', 'cui_str': 'Scoliosis deformity of spine'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C1184923', 'cui_str': 'Lumbar hyperlordosis'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}]",103.0,0.0680831,"Time loaded standing and PASE improved in females compared with males, P = .008 and P = .092, respectively, and PROMIS mental health, physical health, and physical function declined in females compared with males, P = .073, P = .025, and P = .005, respectively.
","[{'ForeName': 'Wendy B', 'Initials': 'WB', 'LastName': 'Katzman', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of California, San Francisco.'}, {'ForeName': 'Neeta', 'Initials': 'N', 'LastName': 'Parimi', 'Affiliation': 'Department of Biostatistics and Epidemiology, University of California, San Francisco.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Gladin', 'Affiliation': 'Rehabilitation Services, Kaiser Permanente San Francisco Medical Center, California.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Wong', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of California, San Francisco.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Lane', 'Affiliation': 'Department of Medicine, University of California, Davis.'}]",Journal of geriatric physical therapy (2001),['10.1519/JPT.0000000000000262']
2617,32796413,"Ergogenic Effects of Photobiomodulation on Performance in the 30-Second Wingate Test: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study.","Molina Correa, JC, Padoin, S, Varoni, PR, Demarchi, MC, Flores, LJ, Nampo, FK, and de Paula Ramos, S. Ergogenic effects of photobiomodulation on performance in the 30-second Wingate test: A randomized, double-blind, placebo-controlled, crossover study. J Strength Cond Res XX(X): 000-000, 2020-The purpose of this study was to evaluate the ergogenic effects of red light (630 nm) photobiomodulation on anaerobic capacity in the Wingate test. Sixteen healthy and physically active male volunteers (21.71 ± 2.49 years of age, body mass index between 18.5 and 24.9 kg/m) participated in this randomized, double-blind, placebo-controlled, crossover study. The subjects performed 3 Wingate test sessions, with a 48-hour interval between tests. In the first session (baseline session, BS), a Wingate test was performed to evaluate the initial performance. Subjects were paired by performance in the BS and allocated through a draw to receive either the phototherapy (630 nm, 4.6 J/cm, 6 J per point, 16 points, light-emitting diode [LED] session) or placebo intervention (PLA session) in the second test session. In the third test session, a crossover intervention was performed. The repeated-measures analysis of variance test, followed by Bonferroni post hoc test or Friedman test with Dunn's post hoc test (p < 0.05) and Cohen's d statistic were used for comparisons. The LED session with phototherapy promoted an increase in performance in peak power (p < 0.05), relative power (p < 0.05), RPMpeak (p < 0.05), and peak velocity (p < 0.05), as well as total displacement (p < 0.01) compared with PLA. The mean power (p < 0.05), relative power (p < 0.05), RPMmean (p < 0.01), and mean velocity (p < 0.01) were higher in the LED session than those of BS. We concluded that phototherapy improves performance in Wingate anaerobic exercise, possibly due to large effects on the anaerobic alactic metabolism.",2020,"The LED session with phototherapy promoted an increase in performance in peak power (p < 0.05), relative power (p < 0.05), RPMpeak (p < 0.05), and peak velocity (p < 0.05), as well as total displacement (p < 0.01) compared with PLA.","['Sixteen healthy and physically active male volunteers (21.71 ± 2.49 years of age, body mass index between 18.5 and 24.9 kg/m']","['J Strength Cond Res XX(X', 'Placebo', 'phototherapy', 'red light (630 nm) photobiomodulation', 'placebo intervention (PLA session', 'Photobiomodulation', 'placebo']","['peak velocity', 'mean power', 'total displacement', 'performance in peak power', 'Molina Correa, JC, Padoin, S, Varoni, PR, Demarchi, MC, Flores, LJ, Nampo, FK, and de Paula Ramos, S. Ergogenic effects', 'anaerobic capacity', 'mean velocity', 'relative power']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C4708661', 'cui_str': '2.49'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517611', 'cui_str': '18.5'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0563227', 'cui_str': 'Red light'}, {'cui': 'C4708165', 'cui_str': '630'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0454740', 'cui_str': 'Flores'}, {'cui': 'C3178747', 'cui_str': 'Performance-Enhancing Effects'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",16.0,0.439235,"The LED session with phototherapy promoted an increase in performance in peak power (p < 0.05), relative power (p < 0.05), RPMpeak (p < 0.05), and peak velocity (p < 0.05), as well as total displacement (p < 0.01) compared with PLA.","[{'ForeName': 'Julio C', 'Initials': 'JC', 'LastName': 'Molina Correa', 'Affiliation': 'State University of Londrina, Londrina, Paraná, Brazil.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Padoin', 'Affiliation': 'State University of Londrina, Londrina, Paraná, Brazil.'}, {'ForeName': 'Pedro R', 'Initials': 'PR', 'LastName': 'Varoni', 'Affiliation': 'Department of Physical Education, State University of Western Paraná, Campus de Marechal Cândido Rondon, Marechal Cândido Rondon, Paraná, Brazil.'}, {'ForeName': 'Michelli C', 'Initials': 'MC', 'LastName': 'Demarchi', 'Affiliation': 'Department of Physical Education, State University of Western Paraná, Campus de Marechal Cândido Rondon, Marechal Cândido Rondon, Paraná, Brazil.'}, {'ForeName': 'Lucinar J F', 'Initials': 'LJF', 'LastName': 'Flores', 'Affiliation': 'Research Group in Tissue Regeneration, Adaptation, and Repair, State University of Londrina, Londrina, Paraná, Brazil.'}, {'ForeName': 'Fernando K', 'Initials': 'FK', 'LastName': 'Nampo', 'Affiliation': 'Latin American Institute of Science of Life and Nature, Federal University of Latin American Integration, Foz do Iguaçu, Paraná, Brazil.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'de Paula Ramos', 'Affiliation': 'Research Group in Tissue Regeneration, Adaptation, and Repair, State University of Londrina, Londrina, Paraná, Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003734']
2618,32796417,Effects of Integrative Neuromuscular Training on Motor Performance in Prepubertal Soccer Players.,"Menezes, GB, Alexandre, DR, Pinto, JC, Assis, TV, Faigenbaum, AD, and Mortatti, AL. Effects of integrative neuromuscular training on motor performance in prepubertal soccer players. J Strength Cond Res XX(X): 000-000, 2020-The present study examined the effects of integrative neuromuscular training (INT) on motor performance in prepubertal soccer players. Subjects were randomly assigned to the experimental group (INT; n = 20, age: 8.2 ± 1.2 years; body mass: 28.4 ± 6.4 kg; height: 1.3 ± 0.1 m) or the control group (CON; n = 18, age: 8.5 ± 1.3 years; body mass: 32.8 ± 8.9 kg; height: 1.3 ± 0.1 m). Integrative neuromuscular training program was performed twice per week during the 12-week training intervention. Balance, flexibility, countermovement vertical jump height (CVJH), sprint speed, and change of direction speed (CODS) were assessed in both groups at baseline, sixth week and 12th week. A mixed model repeated measures analysis of variance was used to examine the group changes in performance for each variable. There was a time effect for balance in the INT from pre to 12th weeks (p < 0.001, g = 0.72), and from 6th to 12th weeks (p = 0.005, g = 0.34). An interaction effect for balance was also observed between INT and CON after the 12th week. A time effect in flexibility was observed in INT from baseline to 6th and 12th weeks (p = 0.02; g = 0.45 and p < 0.001; g = 0.71) and from 6 to 12th weeks (p = 0.003; g = 0.24). There was a time effect in CVJH, from baseline to 12th week and from 6th to 12th weeks (p < 0.05; g = 0.34 and g = 0.53, respectively). There was no significant between-group speed performance change. A time effect was found in CODS in INT, but only from baseline to 12th week (p = 0.02; g = 0.31). There were significant improvements in the percent change (Δ%) from baseline to 12 weeks (p < 0.05) for balance, flexibility, and CVJH in INT. These findings indicate that the addition of an INT program to soccer practice can improve selected motor performance skills in prepubertal soccer players.",2020,"There were significant improvements in the percent change (Δ%) from baseline to 12 weeks (p < 0.05) for balance, flexibility, and CVJH in INT.","[' 000-000', 'prepubertal soccer players', 'Prepubertal Soccer Players']","['integrative neuromuscular training', 'J Strength Cond Res XX(X', 'Integrative Neuromuscular Training', 'Integrative neuromuscular training program', 'integrative neuromuscular training (INT']","['Motor Performance', 'selected motor performance skills', 'flexibility', 'Menezes, GB, Alexandre, DR, Pinto, JC, Assis, TV, Faigenbaum, AD, and Mortatti, AL', 'Balance, flexibility, countermovement vertical jump height (CVJH), sprint speed, and change of direction speed (CODS', 'balance, flexibility, and CVJH in INT', 'motor performance']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0324179', 'cui_str': 'Pinto'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",20.0,0.0234106,"There were significant improvements in the percent change (Δ%) from baseline to 12 weeks (p < 0.05) for balance, flexibility, and CVJH in INT.","[{'ForeName': 'Glauber B', 'Initials': 'GB', 'LastName': 'Menezes', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Brazil.'}, {'ForeName': 'Diego R O', 'Initials': 'DRO', 'LastName': 'Alexandre', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Brazil.'}, {'ForeName': 'Júlio C B L', 'Initials': 'JCBL', 'LastName': 'Pinto', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Brazil.'}, {'ForeName': 'Tereza V L', 'Initials': 'TVL', 'LastName': 'Assis', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Brazil.'}, {'ForeName': 'Avery D', 'Initials': 'AD', 'LastName': 'Faigenbaum', 'Affiliation': 'Department of Health and Exercise Science, College of New Jersey, Ewing, New Jersey.'}, {'ForeName': 'Arnaldo L', 'Initials': 'AL', 'LastName': 'Mortatti', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003666']
2619,32796630,Effects of 12-Week Methylphenidate Treatment on Neurometabolism in Adult Patients with ADHD: The First Double-Blind Placebo-Controlled MR Spectroscopy Study.,"Attention deficit hyperactivity disorder (ADHD) is a frequent neurodevelopmental disorder that often persists into adulthood. Methylphenidate (MPH) is the first-line treatment for ADHD; however, despite its wide usage, little is known about its neurometabolic effects. Until now, no randomized and blinded clinical trials have been conducted addressing the neurometabolic signals of MPH administration in adults with ADHD. In the current study, the authors investigated how MPH intake and group psychotherapy (GPT) influence brain neurometabolism over the course of three months. The authors hypothesized a decrease in the anterior cingulate cortex (ACC) glutamate concentration following MPH administration. This study was part of a double-blind multicenter trial (Comparison of Methylphenidate and Psychotherapy in Adult ADHD Study (COMPAS)) investigating the effects of MPH and GPT in patients with adult ADHD. Using single-voxel magnetic resonance spectroscopy (MRS) of the pregenual ACC and the left cerebellar hemisphere (CHL), we investigated the concentration of glutamate plus glutamine (Glx), N-acetyl-aspartate, creatine, total choline containing compounds, and myo-inositol in patients before and after 12 weeks of treatment. Neither MPH nor GPT significantly influenced the Glx concentration or any of the other metabolite concentrations in the ACC and CHL after 12 weeks. Therefore, contrary to the hypothesis, no change in the prefrontal Glx signal was detected after MPH treatment. Given that MRS does not differentiate between glutamate in the synaptic cleft and in neuronal tissue, MPH-induced down-regulation of glutamatergic neurotransmission in the ACC might only affect the concentration of glutamate in the synaptic cleft, while the general availability of glutamate in the respective neuronal tissue might be unaffected by MPH intake. The observed lack of any MPH-induced normalization in metabolite concentrations is less surprising, considering that the baseline sample did not significantly differ from a healthy control group. Future studies of other regions, such as the basal ganglia, and the use of novel methods, such as whole brain MRS and multimodal imaging approaches, are necessary.",2020,Neither MPH nor GPT significantly influenced the Glx concentration or any of the other metabolite concentrations in the ACC and CHL after 12 weeks.,"['Adult Patients with ADHD', 'adults with ADHD', 'patients with adult ADHD']","['Methylphenidate and Psychotherapy', 'MRS', 'Placebo', 'MPH and GPT', 'Methylphenidate', 'MPH intake and group psychotherapy (GPT', 'Methylphenidate (MPH', 'single-voxel magnetic resonance spectroscopy (MRS']","['concentration of glutamate plus glutamine (Glx), N-acetyl-aspartate, creatine, total choline containing compounds, and myo-inositol', 'metabolite concentrations', 'prefrontal Glx signal', 'anterior cingulate cortex (ACC) glutamate concentration', 'Glx concentration']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0865424', 'cui_str': 'Adult attention deficit hyperactivity disorder'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0067684', 'cui_str': 'N-acetyl-L-aspartate'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}]",,0.105742,Neither MPH nor GPT significantly influenced the Glx concentration or any of the other metabolite concentrations in the ACC and CHL after 12 weeks.,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Maier', 'Affiliation': 'Section for Experimental Neuropsychiatry, Department of Psychiatry and Psychotherapy, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79104 Freiburg, Germany.'}, {'ForeName': 'Ludger', 'Initials': 'L', 'LastName': 'Tebartz van Elst', 'Affiliation': 'Section for Experimental Neuropsychiatry, Department of Psychiatry and Psychotherapy, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79104 Freiburg, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Philipsen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Department of Radiology, Medical Physics, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Feige', 'Affiliation': 'Section for Experimental Neuropsychiatry, Department of Psychiatry and Psychotherapy, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79104 Freiburg, Germany.'}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Glauche', 'Affiliation': 'Department of Neurology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Nickel', 'Affiliation': 'Section for Experimental Neuropsychiatry, Department of Psychiatry and Psychotherapy, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79104 Freiburg, Germany.'}, {'ForeName': 'Swantje', 'Initials': 'S', 'LastName': 'Matthies', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79104 Freiburg, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Alm', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty of Mannheim, University of Heidelberg, 68159 Mannheim, Germany.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Sobanski', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty of Mannheim, University of Heidelberg, 68159 Mannheim, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Domschke', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79104 Freiburg, Germany.'}, {'ForeName': 'Evgeniy', 'Initials': 'E', 'LastName': 'Perlov', 'Affiliation': 'Section for Experimental Neuropsychiatry, Department of Psychiatry and Psychotherapy, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79104 Freiburg, Germany.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Endres', 'Affiliation': 'Section for Experimental Neuropsychiatry, Department of Psychiatry and Psychotherapy, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79104 Freiburg, Germany.'}]",Journal of clinical medicine,['10.3390/jcm9082601']
2620,32796734,Design and Validation of a Diet Rich in Slowly Digestible Starch for Type 2 Diabetic Patients for Significant Improvement in Glycemic Profile.,"This study aimed at designing a-diet high in slowly digestible starch (SDS) by carefully selecting high-SDS starchy products and to validate its implementation, acceptance, and impact on the postprandial glycemic response in patients with type 2 diabetes (T2D). Starchy products were screened and classified as being either high (high-SDS) or low (low-SDS) in SDS (in vitro SDS method). A randomized controlled cross-over pilot study was performed: Eight patients with T2D consumed randomly a high-SDS or a low-SDS diet for one week each, while their glycemic profile was monitored for 6 days. Based on 250 food product SDS analyses and dietary recommendations for patients with T2D, the high-SDS and low-SDS diets were designed. The high-SDS diet significantly increased SDS intake and the SDS/carbohydrates proportion compared to the low-SDS diet (61.6 vs. 11.6 g/day and 30% vs. 6%;  p  < 0.0001, respectively). Increasing the SDS/carbohydrate proportion to 50% of the meal was significantly correlated with a 12% decrease in tAUC0-120 min and a 14% decrease in the glycemic peak value ( p  < 0.001 for both). A high-SDS diet can be easily designed by carefully selecting commercial starchy products and providing relevant recommendations for T2D to improve their glycemic profile.",2020,The high-SDS diet significantly increased SDS intake and the SDS/carbohydrates proportion compared to the low-SDS diet (61.6 vs. 11.6 g/day and 30% vs. 6%;  ,"['patients with T2D, the high-SDS and low-SDS diets', 'Eight patients with T2D consumed randomly a high-SDS or a', 'patients with type 2 diabetes (T2D']","['low-SDS diet', 'diet high in slowly digestible starch (SDS']","['SDS/carbohydrate proportion', 'glycemic peak value', 'Glycemic Profile', 'postprandial glycemic response', 'SDS intake and the SDS/carbohydrates proportion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",8.0,0.0165172,The high-SDS diet significantly increased SDS intake and the SDS/carbohydrates proportion compared to the low-SDS diet (61.6 vs. 11.6 g/day and 30% vs. 6%;  ,"[{'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Goux', 'Affiliation': 'Nutrition Research, Mondelēz International, 91400 Saclay, France.'}, {'ForeName': 'Anne-Esther', 'Initials': 'AE', 'LastName': 'Breyton', 'Affiliation': 'Nutrition Research, Mondelēz International, 91400 Saclay, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Meynier', 'Affiliation': 'Nutrition Research, Mondelēz International, 91400 Saclay, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Lambert-Porcheron', 'Affiliation': 'Centre de Recherche en Nutrition Humaine Rhône-Alpes, Univ-Lyon, CarMeN Laboratory, Université Claude Bernard Lyon1, Hospices Civils de Lyon, F-CRIN/FORCE Network, 69100 Pierre Bénite, France.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Sothier', 'Affiliation': 'Centre de Recherche en Nutrition Humaine Rhône-Alpes, Univ-Lyon, CarMeN Laboratory, Université Claude Bernard Lyon1, Hospices Civils de Lyon, F-CRIN/FORCE Network, 69100 Pierre Bénite, France.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Van Den Berghe', 'Affiliation': 'Centre de Recherche en Nutrition Humaine Rhône-Alpes, Univ-Lyon, CarMeN Laboratory, Université Claude Bernard Lyon1, Hospices Civils de Lyon, F-CRIN/FORCE Network, 69100 Pierre Bénite, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Brack', 'Affiliation': 'Statistique Industrielle KHI2 Consulting (KSIC), 60110 Esches, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Normand', 'Affiliation': 'Centre de Recherche en Nutrition Humaine Rhône-Alpes, Univ-Lyon, CarMeN Laboratory, Université Claude Bernard Lyon1, Hospices Civils de Lyon, F-CRIN/FORCE Network, 69100 Pierre Bénite, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Disse', 'Affiliation': 'Centre de Recherche en Nutrition Humaine Rhône-Alpes, Univ-Lyon, CarMeN Laboratory, Université Claude Bernard Lyon1, Hospices Civils de Lyon, F-CRIN/FORCE Network, 69100 Pierre Bénite, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Laville', 'Affiliation': 'Centre de Recherche en Nutrition Humaine Rhône-Alpes, Univ-Lyon, CarMeN Laboratory, Université Claude Bernard Lyon1, Hospices Civils de Lyon, F-CRIN/FORCE Network, 69100 Pierre Bénite, France.'}, {'ForeName': 'Julie-Anne', 'Initials': 'JA', 'LastName': 'Nazare', 'Affiliation': 'Centre de Recherche en Nutrition Humaine Rhône-Alpes, Univ-Lyon, CarMeN Laboratory, Université Claude Bernard Lyon1, Hospices Civils de Lyon, F-CRIN/FORCE Network, 69100 Pierre Bénite, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Vinoy', 'Affiliation': 'Nutrition Research, Mondelēz International, 91400 Saclay, France.'}]",Nutrients,['10.3390/nu12082404']
2621,30953792,Prognostic Implications of Changes in Amino-Terminal Pro-B-Type Natriuretic Peptide in Acute Decompensated Heart Failure: Insights From ASCEND-HF.,"BACKGROUND


Amino-terminal pro-B-type natriuretic peptide (NTproBNP) is closely associated with prognosis in acute decompensated heart failure (ADHF). As a result, there has been great interest measuring it during the course of treatment. The prognostic implications in both short-term and follow-up changes in NTproBNP need further clarification.
METHODS


Baseline, 48-72 hour, and 30-day NTproBNP levels were measured in 795 subjects in the ASCEND-HF trial. Multivariable logistic and Cox-proportional hazards models were used to test the association between static, relative, and absolute changes in NTproBNP with outcomes during and after ADHF.
RESULTS


The median NTproBNP at baseline was 5773 (2981-11,579) pg/mL; at 48-72 hours was 3036 (1191-6479) pg/mL; and at 30 days was 2914 (1364-6667) pg/mL. Absolute changes in NTproBNP by 48-72 hours were not associated with 30-day heart failure rehospitalization or mortality (P = .065), relative changes in NTproBNP were nominally associated (P = .046). In contrast, both absolute and relative changes in NTproBNP from baseline to 48-72 hours and to 30 days were closely associated with 180-day mortality (P < .02 for all) with increased discrimination compared to the multivariable models with baseline NTproBNP (P <.05 for models with relative and absolute change at both time points).
CONCLUSIONS


Although the degree of absolute change in NTproBNP was dependent on baseline levels, both short-term absolute and relative changes in NTproBNP were independently and incrementally associated with long-term clinical outcomes. Changes in NTproBNP levels at 30-days were particularly well associated with long-term clinical outcomes.",2019,Changes in NTproBNP levels at 30-days were particularly well associated with long-term clinical outcomes.,"['795 subjects in the ASCEND-HF trial', 'Baseline, 48-72 hour, and', 'acute decompensated heart failure (ADHF', 'Acute Decompensated Heart Failure']",[],"['NTproBNP levels', 'median NTproBNP', '30-day NTproBNP levels', '180-day mortality', 'relative changes in NTproBNP', '30-day heart failure rehospitalization or mortality']","[{'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",[],"[{'cui': 'C0669479', 'cui_str': 'pro-brain natriuretic peptide (1-76)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",,0.0545103,Changes in NTproBNP levels at 30-days were particularly well associated with long-term clinical outcomes.,"[{'ForeName': 'Justin L', 'Initials': 'JL', 'LastName': 'Grodin', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Max J', 'Initials': 'MJ', 'LastName': 'Liebo', 'Affiliation': 'Department of Cardiology, Loyola University Medical Center, Maywood, Illinois.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi, Jackson, Mississippi.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'Department of Cardiology, University of Brescia, Brescia, Italy.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Duke University Medical Center, Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke University Medical Center, Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'Hanzeplein 1, University Med Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McMurray', 'Affiliation': 'University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'Department of Cardiology, University of Alberta, Edmonton, Canada; Inova Heart and Vascular Institute.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': ""O'Connor"", 'Affiliation': 'Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Randall C', 'Initials': 'RC', 'LastName': 'Starling', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Troughton', 'Affiliation': 'University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'W H Wilson', 'Initials': 'WHW', 'LastName': 'Tang', 'Affiliation': 'Heart and Vascular Institute, Falls Church, Virginia. Electronic address: tangw@ccf.org.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2019.04.002']
2622,31174716,The payer's role in addressing the opioid epidemic: It's more than money.,"BACKGROUND AND OBJECTIVE


County, State, and Federal agencies are addressing the public health opioid crisis. Ohio's 51 county-based Alcohol, Drug Addiction and Mental Health Services (ADAMHS) Boards finance and regulate opioid treatment services within their jurisdictions. This three-year comparative trial collaborated with ADAMHS Boards (n = 14) to test the Advancing Recovery Framework, a suite of organizational and system change strategies designed to promote use of buprenorphine for opioid agonist therapy.
METHODS


A multi-level intervention directed payers and treatment agencies to leverage their roles in increasing the use of buprenorphine. Half of the boards partnered with local substance use disorder treatment providers using the partnership strategies recommended by the Advancing Recovery (AR) framework. The comparison boards did not use the partnership strategies.
RESULTS AND CONCLUSION


A logistic regression analysis detected increases in the number of patients receiving buprenorphine in both conditions. Buprenorphine use, as a percentage of patients with an opioid use disorder diagnosis, was significantly greater among the boards using the Advancing Recovery strategies during the three-year experimental period (odds ratio (OR) 1.63, 95% CI, 1.50 to 1.76, p < .001) and a one-year maintenance period (OR 2.13, 95% CI, 1.85 to 2.46, p < .001). Boards in both groups provided similar levels of financial support to implement and maintain buprenorphine prescribing. Strategy differences between the study conditions existed in use of a committee that facilitated payer-provider partnering and the ADAMHS boards setting expectations for using buprenorphine. Payer-provider partnerships achieved greater improvements and maximized the effectiveness of funding in increasing access to buprenorphine.",2019,Payer-provider partnerships achieved greater improvements and maximized the effectiveness of funding in increasing access to buprenorphine.,"[""Ohio's 51 county-based Alcohol, Drug Addiction and Mental Health Services (ADAMHS) Boards finance and regulate opioid treatment services within their jurisdictions""]","['buprenorphine', 'Buprenorphine']",[],"[{'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1510472', 'cui_str': 'Drug dependence'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]",[],,0.029072,Payer-provider partnerships achieved greater improvements and maximized the effectiveness of funding in increasing access to buprenorphine.,"[{'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Molfenter', 'Affiliation': 'University of Wisconsin-Madison, 1513 University Avenue, Madison, WI 53706, United States of America. Electronic address: todd.molfenter@chess.wisc.edu.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'McCarty', 'Affiliation': 'Oregon Health & Science University, United States of America.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Jacobson', 'Affiliation': 'University of Wisconsin-Madison, 1513 University Avenue, Madison, WI 53706, United States of America.'}, {'ForeName': 'Jee-Seon', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'University of Wisconsin-Madison, 1513 University Avenue, Madison, WI 53706, United States of America.'}, {'ForeName': 'Sanford', 'Initials': 'S', 'LastName': 'Starr', 'Affiliation': 'Ohio Department of Mental Health and Addiction Services (OhioMHAS), United States of America.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Zehner', 'Affiliation': 'University of Wisconsin-Madison, 1513 University Avenue, Madison, WI 53706, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.04.001']
2623,31228612,Altered cerebral pain processing of noxious stimuli from inflamed joints in rheumatoid arthritis: An event-related fMRI study.,"OBJECTIVE


To our knowledge, this is the first study assessing brain activation in response to painful stimulation over disease-relevant (finger joint) vs. neutral area (thumb nail) in patients suffering from rheumatoid arthritis (RA) compared to healthy controls (HC).
METHOD


Thirty-one RA patients and 23 HC underwent functional magnetic resonance imaging (fMRI) while stimulated with subjectively calibrated painful pressures corresponding to a pain sensation of 50 mm on a 100 mm VAS scale (P50) at disease-affected finger joint and thumbnail (left hand), and corresponding sites in HC.
RESULTS


Compared to controls, RA patients had significantly increased pain sensitivity (lower P50) at the inflamed joints but not at the thumbnail. RA patients exhibited significantly less activation in regions related to pain- and somatosensory processing (S1, M1, anterior insula, S2, SMG and MCC) during painful joint stimulation, compared to HC. No group difference in cerebral pain processing was found for the non-affected thumbnail. Within RA patients, significantly less brain activation was found in response to painful stimulation over disease-affected joint compared to non-affected thumbnail in bilateral S1, bilateral S2, and anterior insula. Further, RA patients exhibited a right-sided dlPFC deactivation, psycho-physiologically interacting (PPI) with the left dlPFC in response to painful stimulation at disease-affected joints.
CONCLUSION


The results indicate normal pain sensitivity and cerebral pain processing in RA for non-affected sites, while the increased sensitivity at inflamed joints indicate peripheral/spinal sensitization. Brain imaging data suggest that disease-relevant pain processing in RA is marked by aberrations and a failed initiation of cortical top-down regulation.",2019,"Compared to controls, RA patients had significantly increased pain sensitivity (lower P50) at the inflamed joints but not at the thumbnail.","['patients suffering from rheumatoid arthritis (RA) compared to healthy controls (HC', 'Thirty-one RA patients and 23 HC underwent', 'rheumatoid arthritis']",['functional magnetic resonance imaging (fMRI'],"['brain activation', 'normal pain sensitivity and cerebral pain processing', 'cerebral pain processing', 'pain sensitivity', 'right-sided dlPFC deactivation, psycho-physiologically interacting (PPI', 'pain- and somatosensory processing (S1, M1, anterior insula, S2, SMG and MCC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0450355', 'cui_str': '31'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0228259', 'cui_str': 'Anterior insula'}, {'cui': 'C0007129', 'cui_str': 'Merkel cell carcinoma'}]",31.0,0.0199615,"Compared to controls, RA patients had significantly increased pain sensitivity (lower P50) at the inflamed joints but not at the thumbnail.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sandström', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Department of Neuroradiology, Karolinska University Hospital, Stockholm, Sweden. Electronic address: angelica.sandstrom@ki.se.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ellerbrock', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Department of Neuroradiology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Jensen', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Department of Neuroradiology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Martinsen', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Department of Neuroradiology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Altawil', 'Affiliation': 'Department of Medicine, Rheumatology Unit, Center for Molecular Medicine (CMM), Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hakeberg', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Department of Neuroradiology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fransson', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Department of Neuroradiology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lampa', 'Affiliation': 'Department of Medicine, Rheumatology Unit, Center for Molecular Medicine (CMM), Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kosek', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Department of Neuroradiology, Karolinska University Hospital, Stockholm, Sweden.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2019.06.024']
2624,32795098,"Cangrelor, Tirofiban, and Chewed or Standard Prasugrel Regimens in Patients With ST-Segment-Elevation Myocardial Infarction: Primary Results of the FABOLUS-FASTER Trial.","BACKGROUND


Standard administration of newer oral P2Y 12  inhibitors, including prasugrel or ticagrelor, provides suboptimal early inhibition of platelet aggregation (IPA) in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention. We aimed to investigate the effects of cangrelor, tirofiban, and prasugrel, administered as chewed or integral loading dose, on IPA in patients undergoing primary percutaneous coronary intervention.
METHODS


The FABOLUS-FASTER trial (Facilitation Through Aggrastat or Cangrelor Bolus and Infusion Over Prasugrel: A Multicenter Randomized Open-Label Trial in Patients with ST-Elevation Myocardial Infarction Referred for Primary Percutaneous Intervention) is an investigator-initiated, multicenter, open-label, randomized study. A total of 122 P2Y 12 -naive patients with ST-segment-elevation myocardial infarction were randomly allocated (1:1:1) to cangrelor (n=40), tirofiban (n=40) (both administered as bolus and 2-hour infusion followed by 60 mg of prasugrel), or 60-mg loading dose of prasugrel (n=42). The latter group underwent an immediate 1:1 subrandomization to chewed (n=21) or integral (n=21) tablets administration. The trial was powered to test 3 hypotheses (noninferiority of cangrelor compared with tirofiban using a noninferiority margin of 9%, superiority of both tirofiban and cangrelor compared with chewed prasugrel, and superiority of chewed prasugrel as compared with integral prasugrel, each with α=0.016 for the primary end point, which was 30-minute IPA at light transmittance aggregometry in response to 20 μmol/L adenosine diphosphate.
RESULTS


At 30 minutes, cangrelor did not satisfy noninferiority compared with tirofiban, which yielded superior IPA over cangrelor (95.0±8.9 versus 34.1±22.5;  P <0.001). Cangrelor or tirofiban were both superior to chewed prasugrel (IPA, 10.5±11.0;  P <0.001 for both comparisons), which did not provide higher IPA over integral prasugrel (6.3±11.4;  P =0.47), despite yielding higher prasugrel active metabolite concentration (ng/mL; 62.3±82.6 versus 17.1±43.5;  P =0.016).
CONCLUSIONS


Cangrelor provided inferior IPA compared with tirofiban; both treatments yielded greater IPA compared with chewed prasugrel, which led to higher active metabolite concentration but not greater IPA compared with integral prasugrel. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02978040; URL: https://www.clinicaltrialsregister.eu; EudraCT 2017-001065-24.",2020,"CONCLUSIONS


Cangrelor provided inferior IPA compared with tirofiban; both treatments yielded greater IPA compared with chewed prasugrel, which led to higher active metabolite concentration but not greater IPA compared with integral prasugrel.","['122 P2Y 12 -naive patients with ST-segment-elevation myocardial infarction', 'Patients With ST-Segment-Elevation Myocardial Infarction', 'Patients with ST-Elevation Myocardial Infarction Referred for Primary Percutaneous Intervention', 'patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention', 'patients undergoing primary percutaneous coronary intervention']","['tirofiban (n=40) (both administered as bolus and 2-hour infusion followed by 60 mg of prasugrel), or 60-mg loading dose of prasugrel', 'tirofiban', 'Cangrelor or tirofiban', 'prasugrel or ticagrelor', 'cangrelor, tirofiban, and prasugrel', 'Prasugrel', 'Cangrelor, Tirofiban, and Chewed or Standard Prasugrel Regimens', 'cangrelor', 'tirofiban and cangrelor']","['active metabolite concentration', 'prasugrel active metabolite concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0247025', 'cui_str': 'tirofiban'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1121991', 'cui_str': 'cangrelor'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}]",,0.176081,"CONCLUSIONS


Cangrelor provided inferior IPA compared with tirofiban; both treatments yielded greater IPA compared with chewed prasugrel, which led to higher active metabolite concentration but not greater IPA compared with integral prasugrel.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Gargiulo', 'Affiliation': 'Department of Cardiology (G.G., F.G., N.M., L.H., S.W., M.V.), University of Bern, Switzerland.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': 'Department of Advanced Biomedical Sciences, Federico II University of Naples, Italy (G.G., G.E., M.A., R.P., P.C.).'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Avvedimento', 'Affiliation': 'Department of Advanced Biomedical Sciences, Federico II University of Naples, Italy (G.G., G.E., M.A., R.P., P.C.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nagler', 'Affiliation': 'University Institute of Clinical Chemistry, Inselspital (M.N.), University of Bern, Switzerland.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Minuz', 'Affiliation': 'Department of Medicine, Unit of General Medicine for the Study and Treatment of Hypertensive Disease, University of Verona, Policlinico GB Rossi, Italy (P.M.).'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Campo', 'Affiliation': 'Cardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, Italy (G.C., M.T.).'}, {'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Gragnano', 'Affiliation': 'Department of Cardiology (G.G., F.G., N.M., L.H., S.W., M.V.), University of Bern, Switzerland.'}, {'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Manavifar', 'Affiliation': 'Department of Cardiology (G.G., F.G., N.M., L.H., S.W., M.V.), University of Bern, Switzerland.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Piccolo', 'Affiliation': 'Department of Advanced Biomedical Sciences, Federico II University of Naples, Italy (G.G., G.E., M.A., R.P., P.C.).'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Tebaldi', 'Affiliation': 'Cardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, Italy (G.C., M.T.).'}, {'ForeName': 'Plinio', 'Initials': 'P', 'LastName': 'Cirillo', 'Affiliation': 'Department of Advanced Biomedical Sciences, Federico II University of Naples, Italy (G.G., G.E., M.A., R.P., P.C.).'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Hunziker', 'Affiliation': 'Department of Cardiology (G.G., F.G., N.M., L.H., S.W., M.V.), University of Bern, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology and Intensive Care Medicine, Jessa Ziekenhuis, Faculty of Medicine and Life Sciences at the Hasselt University, Belgium (P.V.).'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Leonardi', 'Affiliation': 'University of Pavia and Fondazione IRCCS Policlinico S Matteo, Italy (S.L.).'}, {'ForeName': 'Dik', 'Initials': 'D', 'LastName': 'Heg', 'Affiliation': 'Bern University Hospital, and Clinical Trials Unit, CTU Bern (D.H.), University of Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology (G.G., F.G., N.M., L.H., S.W., M.V.), University of Bern, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology (G.G., F.G., N.M., L.H., S.W., M.V.), University of Bern, Switzerland.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.046928']
2625,32795144,Content Analysis: First-Time Patient User Challenges with Top-Rated Commercial Diabetes Apps.,"Background/Introduction:  Using a mobile application (app) may improve diabetes self-management. However, the use of diabetes apps is low, possibly due to design and usability issues. The purpose of this study was to identify barriers to app use among adult patients with diabetes who were testing diabetes apps for the first time.  Materials and Methods:  We conducted a content analysis of observation notes and patient comments collected during the testing of two top commercially available diabetes apps as part of a crossover randomized trial. Participants were adult patients with type 1 or type 2 diabetes on insulin therapy. We analyzed field notes and transcriptions of audio recordings. Open coding derived categories of usability issues, which then were grouped into themes and subthemes on usability problem types.  Results:  A total of 92 adult Android smartphone users were recruited online (e.g., Facebook) and in-person postings. Three major themes described problems with data input, app report display and presentation, and self-learning options. Data entry modes were problematic because of overcrowded app screens, complicated ""save data"" steps, and a lack of data entry confirmation. The app icons, wording, entry headings, and analysis reports were not intuitive to understand. Participants wanted self-learning options (e.g., pop-up messages) during app use.  Conclusions:  Patient testing of top commercially available diabetes apps revealed key usability design issues in data entry, app report, and self-help learning options. Good app training for patients is necessary for both initial use and long-term use of diabetes apps to support self-management.",2020,Good app training for patients is necessary for both initial use and long-term use of diabetes apps to support self-management.,"['92 adult Android smartphone users were recruited online (e.g., Facebook) and in-person postings', 'adult patients with diabetes who were testing diabetes apps for the first time', 'Participants were adult patients with type 1 or type 2 diabetes on insulin therapy']",[],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0336541', 'cui_str': 'Android'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],[],92.0,0.036659,Good app training for patients is necessary for both initial use and long-term use of diabetes apps to support self-management.,"[{'ForeName': 'Helen N C', 'Initials': 'HNC', 'LastName': 'Fu', 'Affiliation': 'Center for Aging Science and Care Innovation, School of Nursing, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Jin', 'Affiliation': 'Institute for Health Informatics, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Terrence J', 'Initials': 'TJ', 'LastName': 'Adam', 'Affiliation': 'Institute for Health Informatics, University of Minnesota, Minneapolis, Minnesota, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2020.0128']
2626,32795167,Vitamin D3 supplementation improves glycemic control in type 2 diabetic patients: Results from an Italian clinical trial.,"Background : to evaluate the effects of Vitamin D3 on glyco-metabolic control in type 2 diabetic patients with Vitamin D deficiency.  Methods : one hundred and seventeen patients were randomized to placebo and 122 patients to Vitamin D3. We evaluated anthropometric parameters, glyco-metabolic control, and parathormone (PTH) value at baseline, after 3, and 6 months.  Results : a significant reduction of fasting, and post-prandial glucose was recorded in Vitamin D3 group after 6 months. A significant HbA 1c  decrease was observed in Vitamin D3 (from 7.6% or 60 mmol/mol to 7.1% or 54 mmol) at 6 months compared to baseline, and to placebo (p < 0.05 for both). At the end of the study period, we noticed a change in the amount in doses of oral or subcutaneous hypoglycemic agents and insulin, respectively. The use of metformin, acarbose, and pioglitazone was significantly lower (p = 0.037, p = 0.048, and p = 0.042, respectively) than at the beginning of the study in the Vitamin D3 therapy group. The units of Lispro, Aspart, and Glargine insulin were lower in the Vitamin D3 group at the end of the study (p = 0.031, p = 0.037, and p = 0.035, respectively) than in the placebo group.  Conclusions : in type 2 diabetic patients with Vitamin D deficiency, the restoration of value in the Vitamin D standard has led not only to an improvement in the glyco-metabolic compensation, but also to a reduced posology of some oral hypoglycemic agents and some types of insulin used.",2020,"The use of metformin, acarbose, and pioglitazone was significantly lower (p = 0.037, p = 0.048, and p = 0.042, respectively) than at the beginning of the study in the Vitamin D3 therapy group.","['Methods : one hundred and seventeen patients', 'type 2 diabetic patients with Vitamin D deficiency', 'type 2 diabetic patients']","['metformin, acarbose, and pioglitazone', 'Vitamin D3 therapy', 'Vitamin D3 supplementation', 'Vitamin D3', 'placebo']","['units of Lispro, Aspart, and Glargine insulin', 'Vitamin D3', 'glycemic control', 'anthropometric parameters, glyco-metabolic control, and parathormone (PTH) value', 'reduction of fasting, and post-prandial glucose']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",117.0,0.0501147,"The use of metformin, acarbose, and pioglitazone was significantly lower (p = 0.037, p = 0.048, and p = 0.042, respectively) than at the beginning of the study in the Vitamin D3 therapy group.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Derosa', 'Affiliation': 'Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': ""D'Angelo"", 'Affiliation': 'Laboratory of Molecular Medicine, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Martinotti', 'Affiliation': 'S.A.V.E. Studi Analisi Valutazioni Economiche Research Centre, Milan, Italy.'}, {'ForeName': 'Maria Chiara', 'Initials': 'MC', 'LastName': 'Valentino', 'Affiliation': 'S.A.V.E. Studi Analisi Valutazioni Economiche Research Centre, Milan, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Di Matteo', 'Affiliation': 'S.A.V.E. Studi Analisi Valutazioni Economiche Research Centre, Milan, Italy.'}, {'ForeName': 'Giacomo M', 'Initials': 'GM', 'LastName': 'Bruno', 'Affiliation': 'Department of Management information and production Engineering, University of Bergamo, Bergamo, Italy.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Maffioli', 'Affiliation': 'Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy.'}]",International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition,['10.1024/0300-9831/a000673']
2627,32795267,The effect of problem-based learning after coronary heart disease - a randomised study in primary health care (COR-PRIM).,"BACKGROUND


Cardiac rehabilitation is effective after coronary heart disease (CHD). However, risk factors remain, and patients report fear for recurrence during recovery. Problem-based learning is a pedagogical method, where patients work self-directed in small groups with problem solving of real-life situations to manage CHD risk factors and self-care. We aimed to demonstrate the better effectiveness of problem-based learning over home-sent patient information for evaluating long-term effects of patient empowerment and self-care in patients with CHD. Hypothesis tested: One year of problem-based learning improves patients' empowerment- and self-efficacy, to change self-care compared to 1 year of standardised home-sent patient information after CHD.
METHODS


Patients (N = 157) from rural and urban areas in Sweden between 2011 and 2015 (78% male; age. 68 ± 8.5 years) with CHD verified by percutaneous coronary intervention (PCI) (70.1%) or coronary artery by-pass surgery (CABG) and CABG+PCI or myocardial infarction (29.9%) were randomly assigned to problem-based learning (experimental group; n = 79) or home-sent patient information (controls; n = 78). The problem-based learning intervention consisted of patient education in primary care by nurses tutoring groups of 6-9 patients on 13 occasions over 1 year. Controls received home-sent patient information on 11 occasions during the study year.
RESULTS


At one-year follow-up, the primary outcome, patient empowerment, did not significantly differ between the experimental group and controls. We found no significant differences between the groups regarding the secondary outcomes e.g. self-efficacy, although we found significant differences for body mass index (BMI) [- 0.17 (SD 1.5) vs. 0.50 (SD 1.6), P = 0.033], body weight [- 0.83 (SD) 4.45 vs. 1.14 kg (SD 4.85), P = 0.026] and HDL cholesterol [0.1 (SD 0.7) vs. 0.0 mmol/L (SD 0.3), P = 0.038] favouring the experimental group compared to controls.
CONCLUSIONS


The problem-based learning- and the home-sent patient information interventions had similar results regarding patient empowerment, self-efficacy, and well-being. However, problem-based learning exhibited significant effects on weight loss, BMI, and HDL cholesterol levels, indicating that this intervention positively affected risk factors compared to the home-sent patient information.
TRIAL REGISTRATION


NCT01462799 (February 2020).",2020,"At one-year follow-up, the primary outcome, patient empowerment, did not significantly differ between the experimental group and controls.","['primary health care (COR-PRIM', 'Patients (N\xa0=\u2009157) from rural and urban areas in Sweden between 2011 and 2015 (78% male; age', 'patients with CHD', '68\u2009±\u20098.5\u2009years) with CHD verified by percutaneous coronary intervention (PCI) (70.1%) or coronary artery by-pass surgery (CABG) and CABG+PCI or myocardial infarction (29.9']","['problem-based learning', 'problem-based learning (experimental group; n\u2009=\u200979) or home-sent patient information']","['body weight', 'weight loss, BMI, and HDL cholesterol levels', 'HDL cholesterol', 'body mass index (BMI']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C0243013', 'cui_str': 'Problem-Based Learning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}]",,0.0734807,"At one-year follow-up, the primary outcome, patient empowerment, did not significantly differ between the experimental group and controls.","[{'ForeName': 'Anita Kärner', 'Initials': 'AK', 'LastName': 'Köhler', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, SE-581 83, Linköping, Sweden. anita.karner@liu.se.'}, {'ForeName': 'Tiny', 'Initials': 'T', 'LastName': 'Jaarsma', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, SE-581 83, Linköping, Sweden.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Tingström', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, SE-581 83, Linköping, Sweden.'}, {'ForeName': 'Staffan', 'Initials': 'S', 'LastName': 'Nilsson', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, SE-581 83, Linköping, Sweden.'}]",BMC cardiovascular disorders,['10.1186/s12872-020-01647-2']
2628,32795597,Racial disparities in out-of-hospital cardiac arrest interventions and survival in the Pragmatic Airway Resuscitation Trial.,"BACKGROUND


Prior studies have reported racial disparities in survival from out-of-hospital cardiac arrest (OHCA). However, these studies did not evaluate the association of race with OHCA course of care and outcomes. The purpose of this study was to evaluate racial disparities in OHCA airway placement success and patient outcomes in the multicenter Pragmatic Airway Resuscitation Trial (PART).
METHOD


We conducted a secondary analysis of adult OHCA patients enrolled in PART. The parent trial randomized subjects to initial advanced airway management with laryngeal tube or endotracheal intubation. For this analysis, the primary independent variable was patient race categorized by emergency medical services (EMS) as white, black, Hispanic, other, and unknown. We used general estimating equations to examine the association of race with airway attempt success, 72-h survival, and survival to hospital discharge, adjusting for sex, age, witness status, bystander cardiopulmonary resuscitation (CPR), initial rhythm, arrest location, and PART randomization cluster.
RESULTS


Of 3002 patients, EMS-assessed race as 1537 white, 860 black, 163 Hispanic, 90 other, and 352 unknown. Initial shockable rhythms (13.8% vs. 21.5%, p < 0.001), bystander CPR (35.6% vs. 51.4%, p < 0.001), and survival to hospital discharge (7.6% vs. 10.8%, p = 0.011) were lower for black compared to white patients. After adjustment for confounders, no difference was seen in airway success, 72-h survival, and survival to hospital discharge by race.
CONCLUSIONS


In one of the largest studies evaluating differences in prehospital airway interventions and outcomes by EMS-assessed race for OHCA patients, we found no significant adjusted differences between airway success or survival outcomes.",2020,"After adjustment for confounders, no difference was seen in airway success, 72-h survival, and survival to hospital discharge by race.
","[' EMS-assessed race as 1537 white, 860 black, 163 Hispanic, 90 other, and 352 unknown', '3002 patients', 'adult OHCA patients enrolled in PART']",['initial advanced airway management with laryngeal tube or endotracheal intubation'],"['association of race with airway attempt success, 72-h survival, and survival to hospital discharge, adjusting for sex, age, witness status, bystander cardiopulmonary resuscitation (CPR), initial rhythm, arrest location, and PART randomization cluster', 'airway success, 72-h survival, and survival to hospital discharge by race', 'Initial shockable rhythms', 'survival to hospital discharge', 'bystander CPR', 'airway success or survival outcomes']","[{'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",3002.0,0.089249,"After adjustment for confounders, no difference was seen in airway success, 72-h survival, and survival to hospital discharge by race.
","[{'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lupton', 'Affiliation': 'Oregon Health & Science University, United States. Electronic address: lupton@ohsu.edu.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Schmicker', 'Affiliation': 'University of Washington School of Medicine, United States.'}, {'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Aufderheide', 'Affiliation': 'Medical College of Wisconsin, United States.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Blewer', 'Affiliation': 'Duke University School of Medicine, United States.'}, {'ForeName': 'Clifton', 'Initials': 'C', 'LastName': 'Callaway', 'Affiliation': 'University of Pittsburgh School of Medicine, United States.'}, {'ForeName': 'Jestin N', 'Initials': 'JN', 'LastName': 'Carlson', 'Affiliation': 'Allegheny Health Network, United States.'}, {'ForeName': 'M Riccardo', 'Initials': 'MR', 'LastName': 'Colella', 'Affiliation': 'Medical College of Wisconsin, United States.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Hansen', 'Affiliation': 'Oregon Health & Science University, United States.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Herren', 'Affiliation': 'University of Washington School of Medicine, United States.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Nichol', 'Affiliation': 'University of Washington School of Medicine, United States.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'University of Texas Health Science Center at Houston, United States.'}, {'ForeName': 'Mohamud R', 'Initials': 'MR', 'LastName': 'Daya', 'Affiliation': 'Oregon Health & Science University, United States.'}]",Resuscitation,['10.1016/j.resuscitation.2020.08.004']
2629,32795619,Three-year results of a randomized controlled trial comparing mechanochemical and thermal ablation in the treatment of insufficient great saphenous veins.,"OBJECTIVES


Mechanochemical ablation (MOCA) is a non-thermal non-tumescent method of treating saphenous vein insufficiency. The feasibility and short-term results of MOCA are good, but its long-term results are unknown. A randomized study was performed to compare MOCA with endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) in the setting of unilateral GSV insufficiency.
METHODS


Venous outpatient clinic patients with varicose veins (CEAP class C2-4) caused by GSV insufficiency were invited to participate in the study; in total, 132 patients filled the inclusion criteria and were willing to participate. Patients were randomized to treatment (2:1:1 for MOCA, EVLA, and RFA, respectively). The state of the GSV with duplex Doppler ultrasound examination and the disease-specific quality of life were assessed at one month, one year, and three years after the treatment.
RESULTS


Some patients declined to continue in the study after randomization; in total, 117 patients underwent treatment. At three years, the occlusion rate was significantly lower with MOCA than with either EVLA or RFA (82% vs. 100%, P = 0.005). Quality of life was similar between the groups. In the MOCA group, GSV's that were preoperatively over 7 mm in diameter were more likely to recanalize during the follow-up period. The partial recanalizations of proximal GSV observed at one year progressed during the follow-up.
CONCLUSIONS


MOCA is a feasible treatment option for outpatient setting, but its technical success rates are inferior compared to endovenous thermal ablation. Its use in large calibre veins should be carefully considered.",2020,Quality of life was similar between the groups.,"['117 patients underwent treatment', 'Venous outpatient clinic patients with varicose veins (CEAP class C2-4) caused by GSV insufficiency were invited to participate in the study; in total, 132 patients filled the inclusion criteria and were willing to participate', 'insufficient great saphenous veins']","['MOCA', 'Mechanochemical ablation (MOCA', 'EVLA', 'MOCA with endovenous laser ablation (EVLA) and radiofrequency ablation (RFA', 'mechanochemical and thermal ablation']","['disease-specific quality of life', 'Quality of life', 'partial recanalizations of proximal GSV', 'occlusion rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0042345', 'cui_str': 'Phlebectasia'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0348007', 'cui_str': 'Laser Ablation'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0677798', 'cui_str': 'Thermal ablation'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0034771', 'cui_str': 'Recanalization'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]",132.0,0.0265649,Quality of life was similar between the groups.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Vähäaho', 'Affiliation': 'Department of Vascular Surgery, Helsinki University Hospital, Helsinki University, Helsinki, Finland. Electronic address: sari.vahaaho@fimnet.fi.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Halmesmäki', 'Affiliation': 'Department of Vascular Surgery, Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Vascular Surgery, Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Albäck', 'Affiliation': 'Department of Vascular Surgery, Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Noronen', 'Affiliation': 'Department of Vascular Surgery, Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Venermo', 'Affiliation': 'Department of Vascular Surgery, Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}]",Journal of vascular surgery. Venous and lymphatic disorders,['10.1016/j.jvsv.2020.08.007']
2630,32795623,Effects of flexibility and strength training on peak hamstring musculotendinous strains during sprinting.,"PURPOSE


Hamstring injury is one of the most common injuries in sports involving sprinting. Hamstring flexibility and strength are often considered as modifiable risk factors for hamstring injury. Understanding the effects of hamstring flexibility or strength training on the biomechanics of the hamstring muscles during sprinting could assist in improving prevention strategies and rehabilitation of these injuries. The purpose of this study was to determine the effects of altering hamstring flexibility or strength on peak hamstring musculotendinous strain during sprinting.
METHODS


A total of 20 male college students (aged 18-24 years) participated and were randomly assigned to either a flexibility intervention group or a strength intervention group. Each participant executed exercise training 3 times a week for 8 weeks. Flexibility, sprinting and isokinetic strength testing were performed before and after the 2 interventions. Paired t-tests were performed to determine hamstring flexibility or strength intervention effects on hamstring optimal musculotendinous lengths and peak hamstring musculotendinous strains during sprinting.
RESULTS


Participants in the flexibility intervention group significantly increased optimal musculotendinous lengths of the semimembranosus and biceps long head (p ≤ 0.026) and decreased peak musculotendinous strains of all 3 bi-articulate hamstring muscles (p ≤ 0.004). Participants in the strength intervention group significantly increased optimal musculotendinous lengths of all 3 hamstring muscles (p ≤ 0.041) and significantly decreased their peak musculotendinous strain during sprinting (p ≤ 0.017).
CONCLUSION


Increasing hamstring flexibility or strength through exercise training may assist in reducing the risk of hamstring injury during sprinting for recreational male athletes.",2020,"Participants in the strength intervention group significantly increased optimal musculotendinous lengths of all 3 hamstring muscles (p ≤ 0.041) and significantly decreased their peak musculotendinous strain during sprinting (p ≤ 0.017).
","['peak hamstring musculotendinous strains during sprinting', '20 male college students (aged 18-24 years', 'recreational male athletes']","['exercise training', 'flexibility intervention group or a strength intervention group', 'flexibility and strength training', 'hamstring flexibility or strength', 'hamstring flexibility or strength training']","['peak musculotendinous strains', 'peak musculotendinous strain', 'Hamstring flexibility and strength', 'optimal musculotendinous lengths of the semimembranosus and biceps long head', 'optimal musculotendinous lengths of all 3 hamstring muscles', 'Flexibility, sprinting and isokinetic strength testing']","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0224452', 'cui_str': 'Semimembranosus muscle structure'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]",20.0,0.0138512,"Participants in the strength intervention group significantly increased optimal musculotendinous lengths of all 3 hamstring muscles (p ≤ 0.041) and significantly decreased their peak musculotendinous strain during sprinting (p ≤ 0.017).
","[{'ForeName': 'Xianglin', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'Biomechanics Laboratory, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Shangxiao', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Biomechanics Laboratory, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Best', 'Affiliation': 'UHealth Sports Medicine Institute, University of Miami, Miami, FL 33136, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Biomechanics Laboratory, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Hanjun', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Biomechanics Laboratory, Beijing Sport University, Beijing 100084, China. Electronic address: lihanjun@bsu.edu.cn.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Center for Human Movement Science, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599-7135, USA. Electronic address: byu@med.unc.edu.'}]",Journal of sport and health science,['10.1016/j.jshs.2020.08.001']
2631,32795738,Predictors of receptivity to an alcohol intervention among mandated students.,"OBJECTIVE


Students in violation of campus alcohol policy often must participate in an alcohol risk reduction intervention, and some mandated students express overt resistance to change. This study tested a priori hypotheses about psychological variables that might predict receptivity to an online brief alcohol intervention.
METHOD


Participants were 193 students (56% male, 88% underclassmen, 70% white) who were referred to the campus Office of Alcohol and Other Drugs after being cited for alcohol policy violations. Before their mandated online alcohol intervention, they completed a baseline assessment consisting of demographics and questionnaires about their alcohol use, attitudes toward moderate and heavy drinking, beliefs about the centrality of alcohol in college life, perceived descriptive and injunctive drinking norms, trait defensiveness, social desirability and response to the event leading to their sanction. They also responded to a set of questions about how interested in, open-minded, and likely to benefit they were from the computer-delivered alcohol intervention they were about to take.
RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
CONCLUSIONS


Among students mandated to participate in an alcohol intervention, openness to benefitting from the intervention varies in predictable ways. Because intervention receptiveness is associated with post-intervention change, we offer suggestions to tailor mandated interventions in ways that might improve outcomes.",2020,"RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
","['Participants were 193 students (56% male, 88% underclassmen, 70% white) who were referred to the campus Office of Alcohol and Other Drugs after being cited for alcohol policy violations', 'mandated students']",['alcohol intervention'],"['heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0242456', 'cui_str': 'Policy'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",193.0,0.0120224,"RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
","[{'ForeName': 'Kate B', 'Initials': 'KB', 'LastName': 'Carey', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States; Department of Behavioral and Social Sciences, Brown University School of Public Health, United States. Electronic address: Kate_Carey@Brown.edu.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'DiBello', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States; Department of Psychology, City University of New York, Brooklyn College, United States.'}, {'ForeName': 'Elora E', 'Initials': 'EE', 'LastName': 'Orazio', 'Affiliation': 'College of Community and Public Affairs, Binghamton University, United States.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Hatch', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States.'}, {'ForeName': 'Nadine R', 'Initials': 'NR', 'LastName': 'Mastroleo', 'Affiliation': 'Department of Psychology, Binghamton University, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106605']
2632,32384051,Feasibility of the Internet Attachment-Based Compassion Therapy in the General Population: Protocol for an Open-Label Uncontrolled Pilot Trial.,"BACKGROUND


Compassion-based interventions delivered over the internet are showing promising results for the promotion of psychological health and well-being. Several studies have highlighted their feasibility, acceptance, and preliminary efficacy. However, this is an incipient field of research, and to the best of our knowledge, there are no data available from Spanish-speaking countries.
OBJECTIVE


The aim of this study is to investigate the feasibility, acceptance, and preliminary efficacy of the Internet Attachment-Based Compassion Therapy (iABCT), a web-based version of the Attachment-Based Compassion Therapy, in Spanish speakers from the general population.
METHODS


This feasibility study features a single-arm, uncontrolled, within-group design with an embedded qualitative and quantitative process evaluation at baseline, immediately after the intervention and at the 3-month follow-up. A minimum of 35 participants from the general population will be allocated to iABCT. Feasibility measures will include attrition rate, patterns of use of the web-based system, and participants' acceptability, usability, and opinion. The primary outcome was measured using the Pemberton Happiness Index. Secondary outcomes were measured using the Compassion Scale, Self-Compassion Scale, Forms of Self-Criticizing/Attacking and Self-Reassuring Scale-Short form, Five Facets of Mindfulness Questionnaire, Relationships Questionnaire, General Health Questionnaire, Non-Attachment Scale, International Positive and Negative Affect Schedule Short Form, Purpose-In-Life Test, and difficulties regarding the practice of compassion (Compassion Practice Quality Questionnaire). Mixed models will be used to evaluate primary and secondary outcome measures. A qualitative content analysis of the participants' qualitative responses will also be performed.
RESULTS


Enrollment started in February 2020 and will be finished in April 2020. Data analysis will start in October 2020.
CONCLUSIONS


To our knowledge, this study will, for the first time, show data on the feasibility, acceptability, and preliminary efficacy of web-based compassion (and self-compassion) training-that is, the adapted iABCT-in Spanish speakers from the general population. Further aspects of their implementation (ie, facilitators, barriers, and unwanted effects) and mechanisms of change will be investigated. This study will allow the revision and fine-tuning of the developed intervention, study design, and planning procedures, as well as the initiation of a future randomized controlled trial.
TRIAL REGISTRATION


Clinicaltrials.gov: NCT03918746. Registered on April 17, 2019. Protocol version 1, 6 March 2019.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/16717.",2020,"Secondary outcomes were measured using the Compassion Scale, Self-Compassion Scale, Forms of Self-Criticizing/Attacking and Self-Reassuring Scale-Short form, Five Facets of Mindfulness Questionnaire, Relationships Questionnaire, General Health Questionnaire, Non-Attachment Scale, International Positive and Negative Affect Schedule Short Form, Purpose-In-Life Test, and difficulties regarding the practice of compassion (Compassion Practice Quality Questionnaire).","['35 participants from the general population', 'Spanish speakers from the general population']","['Internet Attachment-Based Compassion Therapy', 'Internet Attachment-Based Compassion Therapy (iABCT']","['Compassion Scale, Self-Compassion Scale, Forms of Self-Criticizing/Attacking and Self-Reassuring Scale-Short form, Five Facets of Mindfulness Questionnaire, Relationships Questionnaire, General Health Questionnaire, Non-Attachment Scale, International Positive and Negative Affect Schedule Short Form, Purpose-In-Life Test, and difficulties regarding the practice of compassion (Compassion Practice Quality Questionnaire', ""attrition rate, patterns of use of the web-based system, and participants' acceptability, usability, and opinion"", 'Pemberton Happiness Index']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0557055', 'cui_str': 'Reassuring'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0582655', 'cui_str': 'Positive and negative affect schedule'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.123296,"Secondary outcomes were measured using the Compassion Scale, Self-Compassion Scale, Forms of Self-Criticizing/Attacking and Self-Reassuring Scale-Short form, Five Facets of Mindfulness Questionnaire, Relationships Questionnaire, General Health Questionnaire, Non-Attachment Scale, International Positive and Negative Affect Schedule Short Form, Purpose-In-Life Test, and difficulties regarding the practice of compassion (Compassion Practice Quality Questionnaire).","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Campos', 'Affiliation': 'Department of Basic and Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón de la plana, Spain.'}, {'ForeName': 'Mayte', 'Initials': 'M', 'LastName': 'Navarro-Gil', 'Affiliation': 'Instituto de Investigación Sanitaria Aragón (IISAragon), Zaragoza, Spain.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Herrera-Mercadal', 'Affiliation': 'Instituto de Investigación Sanitaria Aragón (IISAragon), Zaragoza, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Martínez-García', 'Affiliation': 'Department of Psychology and Sociology, University of Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Ausiàs', 'Initials': 'A', 'LastName': 'Cebolla', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, Universitat de València, Valencia, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Borao', 'Affiliation': 'Department of Psychology and Sociology, University of Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'López-Del-Hoyo', 'Affiliation': 'Instituto de Investigación Sanitaria Aragón (IISAragon), Zaragoza, Spain.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Castilla', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, Universitat de València, Valencia, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Del Río', 'Affiliation': 'Department of Basic and Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón de la plana, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'García-Campayo', 'Affiliation': 'Instituto de Investigación Sanitaria Aragón (IISAragon), Zaragoza, Spain.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Quero', 'Affiliation': 'Department of Basic and Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón de la plana, Spain.'}]",JMIR research protocols,['10.2196/16717']
2633,32795086,"Dapagliflozin and Cardiac, Kidney and Limb Outcomes in Patients With and Without Peripheral Artery Disease in DECLARE-TIMI 58.","Background:  Patients with peripheral artery disease (PAD) are at heightened risk of cardiovascular complications. The SGLT2 inhibitor (SGLT2i) dapagliflozin reduces the risk for hospitalization for heart failure (HHF) and kidney events in patients with type 2 diabetes mellitus (T2DM). An increased risk of amputation has been observed with canagliflozin in one prior trial. We examined cardiovascular and kidney efficacy and the risk of limb related events in patients with and without peripheral artery disease (PAD) in an exploratory analysis.  Methods:  17,160 patients with T2DM, including 1,025 (6%) with PAD, were randomized. Key efficacy outcomes were MACE (CV Death, MI, stroke), CV Death/HHF, and progression of kidney disease. Amputations, peripheral revascularization and limb ischemic adverse events were site reported and categorized by a blinded reviewer.  Results:  Patients in the placebo arm with PAD versus those without tended to have higher adjusted risk of MACE (Adj HR 1.23, 95% CI 0.97 - 1.56, p=0.094) and significantly higher adjusted risk of CV Death/HHF (Adj HR 1.60, 95% CI 1.21 - 2.12, p=0.0010) and progression of kidney disease (Adj HR 1.51, 95% CI 1.13 - 2.03, p=0.0058). The relative risk reductions with dapagliflozin for CV Death/HHF (HR 0.86 PAD, HR 0.82 no-PAD, p-interaction 0.79) and progression of kidney disease (HR 0.78 PAD, HR 0.76 no-PAD, p-interaction 0.84) were consistent regardless of PAD. There were 560 patients who had at least one limb ischemic event, 454 patients with at least one peripheral revascularization, and 236 patients with at least one amputation with a total of 407 amputations reported. Overall, there were no significant differences in any limb outcome with dapagliflozin vs. placebo including limb ischemic adverse events (HR 1.07, 95% CI 0.90 - 1.26) and amputation (HR 1.09, 95% CI 0.84 - 1.40), with no significant interactions by a history of PAD vs. not (P interactions 0.30 and 0.093 respectively).  Conclusions:  Patients with versus without PAD are at higher risk of MACE, CV Death/HHF and kidney outcomes, and have consistent benefits for CV Death/HHF and progression of kidney disease with dapagliflozin. Patients with PAD had higher risk of limb events, with no consistent pattern of incremental risk observed with dapagliflozin.  Clinical Trial Registration:  AstraZeneca URL: http://www.clinicaltrials.gov Unique Identifier: NCT01730534.",2020,"Overall, there were no significant differences in any limb outcome with dapagliflozin vs. placebo including limb ischemic adverse events (HR 1.07, 95% CI 0.90 - 1.26) and amputation (HR 1.09, 95% CI 0.84 - 1.40), with no significant interactions by a history of PAD vs. not (P interactions 0.30 and 0.093 respectively).  ","['17,160 patients with T2DM, including 1,025 (6%) with PAD', 'Patients', '560 patients who had at least one limb ischemic event, 454 patients with at least one peripheral revascularization, and 236 patients with at least one amputation with a total of 407 amputations reported', 'patients with and without peripheral artery disease (PAD) in an exploratory analysis', 'patients with type 2 diabetes mellitus (T2DM', 'Patients with peripheral artery disease (PAD']","['SGLT2 inhibitor (SGLT2i) dapagliflozin', 'dapagliflozin vs. placebo', 'canagliflozin', 'placebo']","['Dapagliflozin and Cardiac, Kidney and Limb Outcomes', 'adjusted risk of CV Death/HHF', 'progression of kidney disease', 'MACE (CV Death, MI, stroke), CV Death/HHF, and progression of kidney disease', 'risk of MACE, CV Death/HHF and kidney outcomes', 'risk of limb events', 'Amputations, peripheral revascularization and limb ischemic adverse events', 'limb ischemic adverse events', 'adjusted risk of MACE', 'risk of amputation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C4517782', 'cui_str': '454'}, {'cui': 'C1096418', 'cui_str': 'Peripheral revascularisation'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C1096418', 'cui_str': 'Peripheral revascularisation'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",17160.0,0.184605,"Overall, there were no significant differences in any limb outcome with dapagliflozin vs. placebo including limb ischemic adverse events (HR 1.07, 95% CI 0.90 - 1.26) and amputation (HR 1.09, 95% CI 0.84 - 1.40), with no significant interactions by a history of PAD vs. not (P interactions 0.30 and 0.093 respectively).  ","[{'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital Heart and Harvard Medical School, Boston, MA; University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital Heart and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Zelniker', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital Heart and Harvard Medical School, Boston, MA; Division of Cardiology, Vienna General Hospital, Medical University of Vienna, Vienna Austria.""}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Hadassah Medical Center, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital Heart and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Goodrich', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital Heart and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Remo Holanda De Mendonca', 'Initials': 'RHM', 'LastName': 'Furtado', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital Heart and Harvard Medical School, Boston, MA; Hospital Albert Einstein and Instituto do Coracao da Faculdade de Medicina da USP, Sao Paulo, Brazil.""}, {'ForeName': 'John P H', 'Initials': 'JPH', 'LastName': 'Wilding', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Avivit', 'Initials': 'A', 'LastName': 'Cahn', 'Affiliation': 'Diabetes Unit, Hadassah Medical Center, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Ingrid A M', 'Initials': 'IAM', 'LastName': 'Gause-Nilsson', 'Affiliation': 'AstraZeneca Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Johanson', 'Affiliation': 'AstraZeneca Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fredriksson', 'Affiliation': 'AstraZeneca Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Johansson', 'Affiliation': 'AstraZeneca Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'Diabetes Unit, Hadassah Medical Center, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital Heart and Harvard Medical School, Boston, MA.""}]",Circulation,['10.1161/CIRCULATIONAHA.119.044775']
2634,32795310,"Effects of canola or olive oil on plasma lipids, lipoprotein-associated phospholipase A 2  and inflammatory cytokines in patients referred for coronary angiography.","BACKGROUND


The potential cardioprotective benefits of olive oil (OO) and canola oil (CO) consumption have been shown in some studies. The present study compared the effects of CO and OO on plasma lipids, some inflammatory cytokines, and lipoprotein-associated phospholipase A 2  (Lp-PLA 2 ) mass and activity in patients undergoing coronary angiography.
METHODS


The current randomized, controlled, parallel-arm, clinical trial involved 48 patients (44 men and 4 women, aged 57.63 ± 6.34 years) with at least one classic cardiovascular risk factor (hypertension, dyslipidemia, or diabetes) who referred for coronary angiography. Patients were randomly divided into two groups and received 25 mL/day refined olive oil (n = 24) or canola oil (n = 24) for 6 weeks. Plasma lipids, some selected inflammatory markers, and Lp-PLA 2  levels were measured at baseline and after the intervention.
RESULTS


CO consumption produced a significant reduction in plasma Lp-PLA 2  mass (- 0.97 ± 1.84 vs. 0.34 ± 1.57 ng/mL, p = 0.008 for CO and OO, respectively), whereas the mean changes in interleukine-6 concentration were significantly lower after OO consumption compared with CO (- 9.46 ± 9.46 vs. -0.90 ± 6.80 pg/mL, p = 0.008 for OO and CO, respectively). After 6 weeks of intervention, no significant changes were observed in plasma Lp-PLA 2  activity, complement C3, C4, or lipid profiles in the two intervention groups.
CONCLUSIONS


Comparing the two vegetable oils in subjects with cardiovascular risk factors showed that the consumption of olive oil is more effective in reducing the level of inflammatory cytokine interleukine-6, whereas canola oil was more effective in lowering Lp-PLA 2  levels; however, this finding should be interpreted with caution, because Lp-PLA 2  activity did not change significantly.
TRIAL REGISTRATION


IRCT20160702028742N5 at www.irct.ir (04/19/2019).",2020,"After 6 weeks of intervention, no significant changes were observed in plasma Lp-PLA 2  activity, complement C3, C4, or lipid profiles in the two intervention groups.
","['patients referred for coronary angiography', 'patients undergoing coronary angiography', 'subjects with cardiovascular risk factors', '48 patients (44 men and 4 women, aged 57.63\u2009±\u20096.34\u2009years) with at least one classic cardiovascular risk factor (hypertension, dyslipidemia, or diabetes) who referred for coronary angiography']","['25\u2009mL/day refined olive oil (n\u2009=\u200924) or canola oil', 'olive oil (OO) and canola oil (CO) consumption', 'canola or olive oil']","['Plasma lipids, some selected inflammatory markers, and Lp-PLA 2  levels', 'interleukine-6 concentration', 'plasma Lp-PLA 2  activity, complement C3, C4, or lipid profiles', 'plasma lipids, lipoprotein-associated phospholipase', 'plasma lipids, some inflammatory cytokines, and lipoprotein-associated phospholipase', 'plasma Lp-PLA 2  mass']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0439446', 'cui_str': 'mL/24h'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0054599', 'cui_str': 'canola oil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0330502', 'cui_str': 'Brassica napus'}]","[{'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0914069', 'cui_str': '1-alkyl-2-acetylglycerophosphocholine esterase'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009506', 'cui_str': 'Complement component C3'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0031671', 'cui_str': 'Phospholipase'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",48.0,0.138053,"After 6 weeks of intervention, no significant changes were observed in plasma Lp-PLA 2  activity, complement C3, C4, or lipid profiles in the two intervention groups.
","[{'ForeName': 'Nafiseh', 'Initials': 'N', 'LastName': 'Khandouzi', 'Affiliation': 'Department of Clinical Nutrition & Dietetics, National Nutrition, and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, No. 7, Hafezi St., Farahzadi Blvd., Qods Town, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Zahedmehr', 'Affiliation': 'Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical & Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Nasrollahzadeh', 'Affiliation': 'Department of Clinical Nutrition & Dietetics, National Nutrition, and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, No. 7, Hafezi St., Farahzadi Blvd., Qods Town, Tehran, Iran. jnasrollahzadeh@gmail.com.'}]",Lipids in health and disease,['10.1186/s12944-020-01362-z']
2635,32795322,Preservation of swallowing in resected oral cavity squamous cell carcinoma: examining radiation volume effects (PRESERVE): study protocol for a randomized phase II trial.,"BACKGROUND


Patients with resected oral cavity squamous cell carcinoma (OCSCC) are often treated with adjuvant radiation (RT) ± concomitant chemotherapy based on pathological findings. Standard RT volumes include all surgically dissected areas, including the tumour bed and dissected neck. RT has significant acute and long-term toxicities including odynophagia, dysphagia, dermatitis and fibrosis. The goal of this study is to assess the rate of regional failure with omission of radiation to the surgically dissected pathologically node negative (pN0) hemi-neck(s) compared to historical control, and to compare oncologic outcomes, toxicity, and quality of life (QoL) profiles between standard RT volumes and omission of RT to the pN0 neck.
METHODS


This is a multicentre phase II study randomizing 90 patients with T1-4 N0-2 OCSCC with at least one pN0 hemi-neck in a 1:2 ratio between standard RT volumes and omission of RT to the pN0 hemi-neck(s). Patients will be stratified based on overall nodal status (nodal involvement vs. no nodal involvement) and use of concurrent chemotherapy. The primary endpoint is regional failure in the pN0 hemi-neck(s); we hypothesize that a 2-year regional recurrence of 20% or less will be achieved. Secondary endpoints include overall and progression-free survival, local recurrence, rate of salvage therapy, toxicity and QoL.
DISCUSSION


This study will provide an assessment of omission of RT to the dissected pN0 hemi-neck(s) on oncologic outcomes, QoL and toxicity. Results will inform the design of future definitive phase III trials.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT03997643 . Date of registration: June 25, 2019, Current version: 2.0 on July 11 2020.",2020,"Secondary endpoints include overall and progression-free survival, local recurrence, rate of salvage therapy, toxicity and QoL.
DISCUSSION


","['resected oral cavity squamous cell carcinoma', '90 patients with T1-4\u2009N0-2 OCSCC with at least one pN0 hemi-neck in a 1:2 ratio between standard RT volumes and omission of RT to the pN0 hemi-neck(s', 'Patients with resected oral cavity squamous cell carcinoma (OCSCC']",['adjuvant radiation (RT)\u2009±\u2009concomitant chemotherapy'],"['overall and progression-free survival, local recurrence, rate of salvage therapy, toxicity and QoL.\nDISCUSSION', 'oncologic outcomes, QoL and toxicity', 'oncologic outcomes, toxicity, and quality of life (QoL) profiles', 'regional failure in the pN0 hemi-neck(s); we hypothesize that a 2-year regional recurrence']","[{'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0585362', 'cui_str': 'Squamous cell carcinoma of mouth'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332396', 'cui_str': 'pN0 category'}, {'cui': 'C1285521', 'cui_str': 'Hemi'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332396', 'cui_str': 'pN0 category'}, {'cui': 'C1285521', 'cui_str': 'Hemi'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0439234', 'cui_str': 'year'}]",90.0,0.0722618,"Secondary endpoints include overall and progression-free survival, local recurrence, rate of salvage therapy, toxicity and QoL.
DISCUSSION


","[{'ForeName': 'Pencilla', 'Initials': 'P', 'LastName': 'Lang', 'Affiliation': 'Division of Radiation Oncology, London Health Sciences Centre, 800 Commissioners Rd. E, London, ON, N6A 5W9, Canada. pencilla.lang@lhsc.on.ca.'}, {'ForeName': 'Jessika', 'Initials': 'J', 'LastName': 'Contreras', 'Affiliation': 'Department of Radiation Oncology, Miami Cancer Institute, Baptist Health South Florida, Miami, Florida, USA.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Kalman', 'Affiliation': 'Department of Radiation Oncology, Miami Cancer Institute, Baptist Health South Florida, Miami, Florida, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Paterson', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'Houda', 'Initials': 'H', 'LastName': 'Bahig', 'Affiliation': ""Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.""}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Billfalk-Kelly', 'Affiliation': ""Department of Radiation Oncology, Eastern Health, St. John's, Newfoundland, Canada.""}, {'ForeName': 'Sinead', 'Initials': 'S', 'LastName': 'Brennan', 'Affiliation': ""Saint Luke's Radiation Oncology Network, Dublin, Ireland.""}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Rock', 'Affiliation': 'Department of Radiation Oncology, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Read', 'Affiliation': 'Division of Radiation Oncology, London Health Sciences Centre, 800 Commissioners Rd. E, London, ON, N6A 5W9, Canada.'}, {'ForeName': 'Varagur', 'Initials': 'V', 'LastName': 'Venkatesan', 'Affiliation': 'Division of Radiation Oncology, London Health Sciences Centre, 800 Commissioners Rd. E, London, ON, N6A 5W9, Canada.'}, {'ForeName': 'Jinka', 'Initials': 'J', 'LastName': 'Sathya', 'Affiliation': 'Division of Radiation Oncology, London Health Sciences Centre, 800 Commissioners Rd. E, London, ON, N6A 5W9, Canada.'}, {'ForeName': 'Lucas C', 'Initials': 'LC', 'LastName': 'Mendez', 'Affiliation': 'Division of Radiation Oncology, London Health Sciences Centre, 800 Commissioners Rd. E, London, ON, N6A 5W9, Canada.'}, {'ForeName': 'S Danielle', 'Initials': 'SD', 'LastName': 'MacNeil', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Western University, London, Ontario, Canada.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Nichols', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Western University, London, Ontario, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Fung', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Western University, London, Ontario, Canada.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Mendez', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Western University, London, Ontario, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Winquist', 'Affiliation': 'Department of Medical Oncology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Kuruvilla', 'Affiliation': 'Department of Medical Oncology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Stewart', 'Affiliation': 'Department of Medical Oncology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Warner', 'Affiliation': 'Division of Radiation Oncology, London Health Sciences Centre, 800 Commissioners Rd. E, London, ON, N6A 5W9, Canada.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Mitchell', 'Affiliation': 'Division of Radiation Oncology, London Health Sciences Centre, 800 Commissioners Rd. E, London, ON, N6A 5W9, Canada.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Theurer', 'Affiliation': 'School of Communication Sciences and Disorders, Western University, London, Ontario, Canada.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Palma', 'Affiliation': 'Division of Radiation Oncology, London Health Sciences Centre, 800 Commissioners Rd. E, London, ON, N6A 5W9, Canada.'}]","Radiation oncology (London, England)",['10.1186/s13014-020-01636-x']
2636,32795330,Auxora versus standard of care for the treatment of severe or critical COVID-19 pneumonia: results from a randomized controlled trial.,"BACKGROUND


Calcium release-activated calcium (CRAC) channel inhibitors stabilize the pulmonary endothelium and block proinflammatory cytokine release, potentially mitigating respiratory complications observed in patients with COVID-19. This study aimed to investigate the safety and efficacy of Auxora, a novel, intravenously administered CRAC channel inhibitor, in adults with severe or critical COVID-19 pneumonia.
METHODS


A randomized, controlled, open-label study of Auxora was conducted in adults with severe or critical COVID-19 pneumonia. Patients were randomized 2:1 to receive three doses of once-daily Auxora versus standard of care (SOC) alone. The primary objective was to assess the safety and tolerability of Auxora. Following FDA guidance, study enrollment was halted early to allow for transition to a randomized, blinded, placebo-controlled study.
RESULTS


In total, 17 patients with severe and three with critical COVID-19 pneumonia were randomized to Auxora and nine with severe and one with critical COVID-19 pneumonia to SOC. Similar proportions of patients receiving Auxora and SOC experienced ≥ 1 adverse event (75% versus 80%, respectively). Fewer patients receiving Auxora experienced serious adverse events versus SOC (30% versus 50%, respectively). Two patients (10%) receiving Auxora and two (20%) receiving SOC died during the 30 days after randomization. Among patients with severe COVID-19 pneumonia, the median time to recovery with Auxora was 5 days versus 12 days with SOC; the recovery rate ratio was 1.87 (95% CI, 0.72, 4.89). Invasive mechanical ventilation was needed in 18% of patients with severe COVID-19 pneumonia receiving Auxora versus 50% receiving SOC (absolute risk reduction = 32%; 95% CI, - 0.07, 0.71). Outcomes measured by an 8-point ordinal scale were significantly improved for patients receiving Auxora, especially for patients with a baseline PaO 2 /FiO 2  = 101-200.
CONCLUSIONS


Auxora demonstrated a favorable safety profile in patients with severe or critical COVID-19 pneumonia and improved outcomes in patients with severe COVID-19 pneumonia. These results, however, are limited by the open-label study design and small patient population resulting from the early cessation of enrollment in response to regulatory guidance. The impact of Auxora on respiratory complications in patients with severe COVID-19 pneumonia will be further assessed in a planned randomized, blinded, placebo-controlled study.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04345614 . Submitted on 7 April 2020.",2020,"Similar proportions of patients receiving Auxora and SOC experienced ≥ 1 adverse event (75% versus 80%, respectively).","['patients with COVID-19', 'patients with severe COVID-19 pneumonia', 'adults with severe or critical COVID-19 pneumonia', 'severe or critical COVID-19 pneumonia', '17 patients with severe and three with critical COVID-19 pneumonia']","['once-daily Auxora versus standard of care (SOC) alone', 'Auxora versus standard of care', 'CRAC channel inhibitor', 'placebo']","['Invasive mechanical ventilation', 'respiratory complications', 'median time to recovery with Auxora', 'recovery rate ratio', 'safety and tolerability of Auxora', 'serious adverse events', '8-point ordinal scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C4277604', 'cui_str': 'Calcium Release-Activated Calcium Channels'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0161818', 'cui_str': 'Respiratory complication'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",17.0,0.297157,"Similar proportions of patients receiving Auxora and SOC experienced ≥ 1 adverse event (75% versus 80%, respectively).","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'Henry Ford Hospital System, Detroit, MI, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Bruen', 'Affiliation': 'Regions Hospital, Health Partners, St. Paul, MN, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schnaus', 'Affiliation': 'Regions Hospital, Health Partners, St. Paul, MN, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Princeton Pharmatech, Princeton, NJ, USA.'}, {'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Methodist Hospital, Park Nicollet, St. Louis Park, MN, USA.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Lind', 'Affiliation': 'Methodist Hospital, Park Nicollet, St. Louis Park, MN, USA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Stoecker', 'Affiliation': 'Methodist Hospital, Park Nicollet, St. Louis Park, MN, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Stauderman', 'Affiliation': 'CalciMedica, Inc., 505 Coast Blvd. South Suite 202, La Jolla, CA, 92037, USA.'}, {'ForeName': 'Sudarshan', 'Initials': 'S', 'LastName': 'Hebbar', 'Affiliation': 'CalciMedica, Inc., 505 Coast Blvd. South Suite 202, La Jolla, CA, 92037, USA. sudarshan@calcimedica.com.'}]","Critical care (London, England)",['10.1186/s13054-020-03220-x']
2637,32795364,Evaluation of Mental Health First Aid from the Perspective Of Workplace End UseRs-EMPOWER: protocol of cluster randomised trial phase.,"BACKGROUND


Mental Health First Aid (MHFA) is a mental health intervention that teaches people how to identify, understand and help someone who may be experiencing a mental health issue. Reviews of the implementation of MHFA found between 68 and 88% of trained Mental Health First Aiders had used their skills when in contact with someone experiencing mental health difficulties. Reviews evaluating the impact of MHFA suggest positive outcomes. However, to date, there has been no systematic, rigorous evaluation of the impact of MHFA on recipients of the intervention, the organisations providing it and the cost-effectiveness of MHFA overall. This trial will evaluate the effectiveness and cost-effectiveness of MHFA.
METHODS


The study is a multi-centred, two-arm clustered randomised controlled trial. Organisations will be randomly allocated to the control or intervention (estimated sample size 800 recipients). The intervention is the standard MHFA intervention provided by Mental Health First Aid England (MHFAE). The control condition will be organisations having a brief consultation from MHFAE on promoting mental health and well-being in the workplace. The primary outcome is health seeking behaviour, measured using the Actual Help Seeking Questionnaire, at 6 months' follow-up. Data collection will be undertaken at baseline (T0), post-intervention-up to 3 months (T1), at 6 months (T2), 12 months (T3) and 24 months (T4). The primary analysis will be conducted on those participants who receive MHFA, a per protocol analysis.
DISCUSSION


The study is the first to evaluate the effect of MHFA in the workplace on employees with direct and indirect experience of the intervention, when compared with usual practice. Being also the first to assess, systematically, the social impact of MHFA and investigate its cost-effectiveness adds to the originality of the study. The study promises to yield important data, as yet unknown, regarding the effectiveness, cost-effectiveness, implementation issues, and the sustainability of MHFA in the workplace.
TRIAL REGISTRATION


Clinicaltrials.gov NCT04311203 . Registered on 17 March 2020.",2020,"The primary outcome is health seeking behaviour, measured using the Actual Help Seeking Questionnaire, at 6 months' follow-up.",[],"['standard MHFA intervention provided by Mental Health First Aid England (MHFAE', 'MHFA']","['health seeking behaviour, measured using the Actual Help Seeking Questionnaire']",[],"[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0016143', 'cui_str': 'First aid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C1321107', 'cui_str': 'Health seeking behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.134721,"The primary outcome is health seeking behaviour, measured using the Actual Help Seeking Questionnaire, at 6 months' follow-up.","[{'ForeName': 'Opeyemi', 'Initials': 'O', 'LastName': 'Atanda', 'Affiliation': 'London South Bank University, London, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Callaghan', 'Affiliation': 'London South Bank University, London, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Carter', 'Affiliation': 'University of Nottingham, Institute of Mental Health and School of Health Sciences, Nottingham, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Durcan', 'Affiliation': 'Centre for Mental Health, London, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': ""O'Shea"", 'Affiliation': 'London South Bank University, London, UK.'}, {'ForeName': 'Steve D', 'Initials': 'SD', 'LastName': 'Brown', 'Affiliation': 'Nottingham Business School, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Reavey', 'Affiliation': 'London South Bank University, London, UK.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Vangeli', 'Affiliation': 'London South Bank University, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'White', 'Affiliation': ""Population Health Research Institute, St George's University of London, London, UK.""}, {'ForeName': 'Kerry V', 'Initials': 'KV', 'LastName': 'Wood', 'Affiliation': 'London South Bank University, London, UK. woodk6@lsbu.ac.uk.'}]",Trials,['10.1186/s13063-020-04636-0']
2638,32795925,Relationship between antofloxacin concentration and QT prolongation and estimation of the possible false-positive rate.,"PURPOSE


To elucidate the relationship between antofloxacin (AT) plasma concentration and QT interval prolongation, compare the effects of different correction and analytical methods on conclusions, and estimate the possible false-positive rate in thorough QT (TQT) studies.
METHODS


Twenty-four healthy Chinese volunteers from a four-period crossover TQT study orally received 200 mg/d AT, 400 mg/d AT, 400 mg/d moxifloxacin, and a placebo in a random order for 5 d for each. QT interval samples were collected on d 1 and d 5. Population models were established describing the relationship between QT and AT concentration. The yardstick from ICH E14 guidelines was used to measure the effect of drugs on QT prolongation both in biostatistical and modeling analyses. A possible false-positive rate was estimated by constructing a 1000-time bootstrap to obtain the rate-of-difference values between d 1 and d 5 over 5 ms in the placebo period.
RESULTS


In the modeling analysis, the QT prolongation estimate at the mean maximal concentration of AT (4.51 μg/mL) was 3.84 ms, and its upper bound of the one-sided 95 % CI was 7.04 ms, which showed a negative effect on QT interval prolongation. The estimation for the false-positive rate was 31 % in this study.
CONCLUSION


The effect of AT on QT interval prolongation may not have been significant at the dosage of 400 mg. Baseline and placebo adjustments were necessary in TQT studies. Population modeling has demonstrated clear superiority in making full use of data to accurately analyze the relationship between drugs and QT intervals.",2020,"In the modeling analysis, the QT prolongation estimate at the mean maximal concentration of AT (4.51 μg/mL) was 3.84 ms, and its upper bound of the one-sided 95 % CI was 7.04 ms, which showed a negative effect on QT interval prolongation.",['Twenty-four healthy Chinese volunteers from a four-period crossover'],"['TQT study orally received 200\u2009mg/d AT, 400\u2009mg/d AT, 400\u2009mg/d moxifloxacin, and a placebo', 'placebo']","['false-positive rate', 'antofloxacin concentration and QT prolongation and estimation of the possible false-positive rate', 'antofloxacin (AT) plasma concentration and QT interval prolongation', 'QT interval samples', 'QT interval prolongation']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C2002223', 'cui_str': 'antofloxacin'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C2002223', 'cui_str': 'antofloxacin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",24.0,0.0861305,"In the modeling analysis, the QT prolongation estimate at the mean maximal concentration of AT (4.51 μg/mL) was 3.84 ms, and its upper bound of the one-sided 95 % CI was 7.04 ms, which showed a negative effect on QT interval prolongation.","[{'ForeName': 'Li-Yu', 'Initials': 'LY', 'LastName': 'Liang', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Ying-Chun', 'Initials': 'YC', 'LastName': 'He', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Yun-Fei', 'Initials': 'YF', 'LastName': 'Li', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Feng-Yan', 'Initials': 'FY', 'LastName': 'Xu', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Lu-Jin', 'Initials': 'LJ', 'LastName': 'Li', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Ji-Han', 'Initials': 'JH', 'LastName': 'Huang', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. Electronic address: huangjihan@shutcm.edu.cn.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. Electronic address: kunwang@139.com.'}, {'ForeName': 'Qing-Shan', 'Initials': 'QS', 'LastName': 'Zheng', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. Electronic address: qingshan.zheng@drugchina.net.'}]",Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie,['10.1016/j.biopha.2020.110619']
2639,32795983,Text Messaging Adherence Intervention for Adolescents and Young Adults with Chronic Kidney Disease: Pilot Randomized Controlled Trial and Stakeholder Interviews.,"BACKGROUND


Up to one-third of adolescents and young adults (11-21 years old) with chronic kidney disease exhibit suboptimal rates of adherence to renal-protective antihypertensive medications. Mobile health interventions may promote higher adherence to these medicines in these individuals, but empirical research is needed to inform best practices for applying these modalities.
OBJECTIVE


In this multiphase investigation, we developed and tested a theoretically informed text messaging intervention based on the COM-B model, a well-established health intervention framework stating that capability, opportunity, and motivation interactively modify health behaviors, to improve participants' antihypertensive medication adherence in a pilot randomized controlled trial. Qualitative data on user experiences were obtained.
METHODS


In phase 1, intervention messages (Reminder+COM-B Message) were developed via stakeholder engagement of participants and pediatric nephrologists. In phase 2, the Reminder+COM-B Message intervention was tested against a Reminder-only Message active control condition in an 8-week pilot randomized controlled trial. The primary outcome was daily electronically monitored antihypertensive medication adherence and secondary outcomes included pre-post participant surveys of adherence self-efficacy, adherence barriers, outcome expectancies for taking medicine, and motivation for and importance of taking medicine. In phase 3, qualitative interviews related to user experiences were conducted with participants in the Reminder+COM-B Message intervention group.
RESULTS


Following phase 1, 34 participants (mean age 16.59 years, 41% female, 38% African American/Black, 35% hypertension diagnosis) completed the phase 2 pilot randomized controlled trial (n=18 in the Reminder+COM-B Message intervention group, n=16 in the Reminder-only Message active control group). All participants in the Reminder+COM-B Message intervention group completed a phase 3 qualitative interview. Overall, study procedures were feasible and the Reminder+COM-B Message intervention was acceptable to the participants (eg, 15/18 participants reported reading the majority of messages sent to them, 0/18 reported that the messages reduced their desire to take medicine). Prerandomization, there were no significant group differences in the rate of change in daily adherence over time. However, postrandomization, there was a significant group by time interaction (B=.01, P=.04) in which daily adherence decreased significantly over time in the Reminder-only Message active control group but remained stable in the Reminder+COM-B Message intervention group. There were no significant differences between groups in pre-post changes in survey responses. Qualitative interviews revealed participants' perceptions of how the Reminder+COM-B Message intervention changed adherence behavior and highlighted several areas for improving the intervention (eg, adapt messaging timing, intensity, and content to match daily adherence, send praise when medicine is taken).
CONCLUSIONS


The Reminder+COM-B Message intervention was feasible and acceptable to adolescents/young adults and demonstrated potential to promote participants' daily medication adherence beyond simple reminders. Further research is needed to determine the Reminder+COM-B Message intervention's mechanisms of adherence behavior change and to incorporate qualitative participant feedback into a modified version of this intervention to enhance its acceptability.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03651596; https://clinicaltrials.gov/ct2/show/NCT03651596.",2020,There were no significant differences between groups in pre-post changes in survey responses.,"['adolescents and young adults (11-21 years old) with chronic kidney disease exhibit suboptimal rates of adherence to renal-protective antihypertensive medications', '34 participants (mean age 16.59 years, 41% female, 38% African American/Black, 35% hypertension diagnosis', 'Adolescents and Young Adults with Chronic Kidney Disease']","['Text Messaging Adherence Intervention', 'Reminder+COM-B Message intervention group', 'Mobile health interventions', 'Reminder+COM-B Message intervention']","['daily adherence', 'time interaction', 'rate of change in daily adherence', 'desire to take medicine', 'daily electronically monitored antihypertensive medication adherence and secondary outcomes included pre-post participant surveys of adherence self-efficacy, adherence barriers, outcome expectancies for taking medicine, and motivation for and importance of taking medicine']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",,0.177456,There were no significant differences between groups in pre-post changes in survey responses.,"[{'ForeName': 'Cyd', 'Initials': 'C', 'LastName': 'Eaton', 'Affiliation': 'Pulmonary & Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Comer', 'Affiliation': 'Pulmonary & Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Cozumel', 'Initials': 'C', 'LastName': 'Pruette', 'Affiliation': 'Division of Pediatric Nephrology, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Psoter', 'Affiliation': 'Division of General Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Riekert', 'Affiliation': 'Pulmonary & Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}]",Journal of medical Internet research,['10.2196/19861']
2640,32795986,Comparing Methods of Recruiting Spanish-Preferring Smokers in the United States: Findings from a Randomized Controlled Trial.,"BACKGROUND


There is a pressing need to address the unacceptable disparities and underrepresentation of racial and ethnic minority groups, including Hispanics or Latinxs, in smoking cessation trials.
OBJECTIVE


Given the lack of research on recruitment strategies for this population, this study aims to assess effective recruitment methods based on enrollment and cost.
METHODS


Recruitment and enrollment data were collected from a nationwide randomized controlled trial (RCT) of a Spanish-language smoking cessation intervention (N=1417). The effectiveness of each recruitment strategy was evaluated by computing the cost per participant (CPP), which is the ratio of direct cost over the number enrolled. More effective strategies yielded lower CPPs. Demographic and smoking-related characteristics of participants recruited via the two most effective strategies were also compared (n=1307).
RESULTS


Facebook was the most effective method (CPP=US $74.12), followed by TV advertisements (CPP=US $191.31), whereas public bus interior card advertising was the least effective method (CPP=US $642.50). Participants recruited via Facebook had lower average age (P=.008) and had spent fewer years in the United States (P<.001). Among the participants recruited via Facebook, a greater percentage of individuals had at least a high school education (P<.001) and an annual income above US $10,000 (P<.001). In addition, a greater percentage of individuals were employed (P<.001) and foreign born (P=.003). In terms of subethnicity, among the subjects recruited via Facebook, a lower percentage of individuals were of Mexican origin (P<.001) and a greater percentage of individuals were of Central American (P=.02), South American (P=.01), and Cuban (P<.001) origin.
CONCLUSIONS


Facebook was the most effective method for recruiting Hispanic or Latinx smokers in the United States for this RCT. However, using multiple methods was necessary to recruit a more diverse sample of Spanish-preferring Hispanic or Latinx smokers.",2020,Participants recruited via Facebook had lower average age (P=.008) and had spent fewer years in the United States (P<.001).,"['Participants recruited via Facebook had lower average age (P=.008) and had spent fewer years in the United States (P<.001', 'participants recruited via Facebook, a greater percentage of individuals had at least a high school education (P<.001) and an annual income above US $10,000 (P<.001', 'Recruitment and enrollment data were collected from a nationwide randomized controlled trial (RCT) of a Spanish-language smoking cessation intervention (N=1417']",[],[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],[],,0.183879,Participants recruited via Facebook had lower average age (P=.008) and had spent fewer years in the United States (P<.001).,"[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Medina-Ramirez', 'Affiliation': 'Tobacco Research & Intervention Program, Department of Health Outcomes & Behavior, Moffitt Cancer Center & Research Institute, Tampa, FL, United States.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Calixte-Civil', 'Affiliation': 'Tobacco Research & Intervention Program, Department of Health Outcomes & Behavior, Moffitt Cancer Center & Research Institute, Tampa, FL, United States.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Meltzer', 'Affiliation': 'Tobacco Research & Intervention Program, Department of Health Outcomes & Behavior, Moffitt Cancer Center & Research Institute, Tampa, FL, United States.'}, {'ForeName': 'Karen O', 'Initials': 'KO', 'LastName': 'Brandon', 'Affiliation': 'Tobacco Research & Intervention Program, Department of Health Outcomes & Behavior, Moffitt Cancer Center & Research Institute, Tampa, FL, United States.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Martinez', 'Affiliation': 'Tobacco Research & Intervention Program, Department of Health Outcomes & Behavior, Moffitt Cancer Center & Research Institute, Tampa, FL, United States.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Sutton', 'Affiliation': 'Department of Psychology, University of South Florida, Tampa, FL, United States.'}, {'ForeName': 'Cathy D', 'Initials': 'CD', 'LastName': 'Meade', 'Affiliation': 'Department of Health Outcomes & Behavior, Moffitt Cancer Center & Research Institute, Tampa, FL, United States.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Byrne', 'Affiliation': 'Department of Health Outcomes & Behavior, Moffitt Cancer Center & Research Institute, Tampa, FL, United States.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Brandon', 'Affiliation': 'Tobacco Research & Intervention Program, Department of Health Outcomes & Behavior, Moffitt Cancer Center & Research Institute, Tampa, FL, United States.'}, {'ForeName': 'Vani N', 'Initials': 'VN', 'LastName': 'Simmons', 'Affiliation': 'Tobacco Research & Intervention Program, Department of Health Outcomes & Behavior, Moffitt Cancer Center & Research Institute, Tampa, FL, United States.'}]",Journal of medical Internet research,['10.2196/19389']
2641,32795987,The Effect of Improved Access to Family Planning on Postpartum Women: Protocol for a Randomized Controlled Trial.,"BACKGROUND


The World Health Organization recommends that a woman waits at least 24 months after a live birth before getting pregnant again; however, an estimated 25% of birth intervals in low-income countries do not meet this recommendation for adequate birth spacing, and the unmet need for postpartum family planning (PPFP) services is high. Few randomized controlled trials have assessed the causal impact of access to PPFP services, and even fewer evaluations have investigated how such interventions may affect postpartum contraceptive use, birth spacing, and measures of health and well-being.
OBJECTIVE


This protocol paper aims to describe a randomized controlled trial that is being conducted to identify the causal impact of an intervention to improve access to PPFP services on contraceptive use, pregnancy, and birth spacing in urban Malawi. The causal effect of the intervention will be determined by comparing outcomes for respondents who are randomly assigned to an intervention arm against outcomes for respondents who are randomly assigned to a control arm.
METHODS


Married women aged 18-35 years who were either pregnant or had recently given birth were randomly assigned to either the intervention arm or control arm. Women assigned to the intervention arm received a package of services over a 2-year intervention period. Services included a brochure and up to 6 home visits from trained family planning counselors; free transportation to a high-quality family planning clinic; and financial reimbursement for family planning services, consultations, and referrals for services. Two follow-up surveys were conducted 1 and 2 years after the baseline survey.
RESULTS


A total of 2143 women were randomly assigned to either the intervention arm (n=1026) or the control arm (n=1117). Data collection for the first follow-up survey began in August 2017 and was completed in February 2018. A total of 1773 women, or 82.73% of women who were eligible for follow-up, were successfully contacted and reinterviewed at the first follow-up. Data collection for the second follow-up survey began in August 2018 and was completed in February 2019. A total of 1669 women, or 77.88% of women who were eligible for follow-up, were successfully contacted and reinterviewed at the second follow-up. The analysis of the primary outcomes is ongoing and is expected to be completed in 2021.
CONCLUSIONS


The results of this trial seek to fill the current knowledge gaps in the effectiveness of family planning interventions on improving fertility and health outcomes. The findings also show that the benefits of improving access to family planning are likely to extend beyond the fertility and health domain by improving other measures of women's well-being.
TRIAL REGISTRATION


American Economics Association Registry Trial Number AEARCTR-0000697; https://www.socialscienceregistry.org/trials/697 Registry for International Development Impact Evaluations (RIDIE) Trial Number RIDIE-STUDY-ID-556784ed86956; https://ridie.3ieimpact.org/index.php?r=search/detailView&id=320.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/16697.",2020,"METHODS


Married women aged 18-35 years who were either pregnant or had recently given birth were randomly assigned to either the intervention arm or control arm.","['urban Malawi', 'A total of 2143 women', 'A total of 1773 women, or 82.73% of women who were eligible for follow-up, were successfully contacted and reinterviewed at the first follow-up', 'A total of 1669 women, or 77.88% of women who were eligible for follow-up, were successfully contacted and reinterviewed at the second follow-up', 'first follow-up survey began in August 2017 and was completed in February 2018', 'Postpartum Women', 'Married women aged 18-35 years who were either pregnant or had recently given birth']","['brochure and up to 6 home visits from trained family planning counselors; free transportation to a high-quality family planning clinic; and financial reimbursement for family planning services, consultations, and referrals for services', 'package of services over a 2-year intervention period']",['fertility and health outcomes'],"[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C1571885', 'cui_str': 'Professional counselor'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3840184', 'cui_str': 'Family planning clinic'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0584065', 'cui_str': 'Referral to service'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",2143.0,0.179633,"METHODS


Married women aged 18-35 years who were either pregnant or had recently given birth were randomly assigned to either the intervention arm or control arm.","[{'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Karra', 'Affiliation': 'Frederick S Pardee School of Global Studies, Boston University, Boston, MA, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Canning', 'Affiliation': 'Department of Global Health and Population, Harvard T H Chan School of Public Health, Harvard University, Boston, MA, United States.'}]",JMIR research protocols,['10.2196/16697']
2642,32798286,Effects of Intravesical Lactobacillus Rhamnosus GGon Urinary Symptom Burden in People with Neurogenic Lower Urinary Tract Dysfunction.,"OBJECTIVE


Test the effectiveness of intravesical Lactobacillus rhamnosus GG (LGG) to reduce the burden of urinary symptoms for individuals with spinal cord injury and disease (SCI/D) with neurogenic lower urinary tract dysfunction (NLUTD) who manage their bladders with intermittent catheterization (IC).
DESIGN


A 3-phase study (6 months each in baseline; intervention; and washout).Participants self-managed following the Self-Management Protocol using Probiotics (SMP-Pro), completing the online Urinary Symptom Questionnaire for Neurogenic Bladder-IC version (USQNB-IC) weekly.
SETTING


Nationwide (US).
PARTICIPANTS


96 adults and 7 children with SCI/D.
INTERVENTIONS


In response to one or both of the SMP-Pro trigger urinary symptoms, ""cloudier"" or ""foul smelling"" urine, subjects self-administered using a clean urinary catheter an LGG+Normal Saline instillate once or twice in a 30-hour period.
MAIN OUTCOME MEASURES


Change in USQNB-IC burden was adjusted individually according to the prior phase for four symptom types. Adjusted changes in burden between the intervention and washout phases were analyzed using one-sample t-tests. Holm correction was applied for the four types of symptoms: A, clinically actionable; B1, bladder function; B2, urine quality; and C, other.
RESULTS


During the intervention phase, participants met SMP-Pro instillation criteria3.83 times on average (range 1 - 20). An average of 5.6 doses of LGG were instilled.For those who instilled at least once, burdens of type A and B2 symptoms were significantly improved at washout (both adjusted p<0.05).
CONCLUSIONS


Self-instilled LGGseemed to improve ""clinically actionable"" (A) and ""urine quality"" (B2) symptom burden. No changes were observed for those who did not instill. This first-in-human clinical trial supports ongoing research of intravesicalLGG, and the SMP-Pro for urinary symptoms. This article is protected by copyright. All rights reserved.",2020,"For those who instilled at least once, burdens of type A and B2 symptoms were significantly improved at washout (both adjusted p<0.05).
","['individuals with spinal cord injury and disease (SCI/D) with neurogenic lower urinary tract dysfunction (NLUTD) who manage their bladders with intermittent catheterization (IC', 'People with Neurogenic Lower Urinary Tract Dysfunction', '96 adults and 7 children with SCI/D', 'Nationwide (US']","['SMP-Pro instillation', 'Intravesical Lactobacillus Rhamnosus GGon Urinary Symptom Burden', 'LGG', 'washout).Participants self-managed following the Self-Management Protocol using Probiotics (SMP-Pro), completing the online Urinary Symptom Questionnaire for Neurogenic Bladder-IC version (USQNB-IC) weekly', 'intravesical Lactobacillus rhamnosus GG (LGG']","['USQNB-IC burden', 'clinically actionable"" (A) and ""urine quality"" (B2) symptom burden', 'burdens of type A and B2 symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0729866', 'cui_str': 'Lower urinary tract structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0005697', 'cui_str': 'Neurogenic bladder'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",96.0,0.0458341,"For those who instilled at least once, burdens of type A and B2 symptoms were significantly improved at washout (both adjusted p<0.05).
","[{'ForeName': 'Rochelle E', 'Initials': 'RE', 'LastName': 'Tractenberg', 'Affiliation': 'Collaborative for Research on Outcomes and -Metrics.'}, {'ForeName': 'Suzanne L', 'Initials': 'SL', 'LastName': 'Groah', 'Affiliation': 'Department of Rehabilitation Medicine, Georgetown University Medical Center, Washington, D.C.'}, {'ForeName': 'Jamie K', 'Initials': 'JK', 'LastName': 'Frost', 'Affiliation': 'Collaborative for Research on Outcomes and -Metrics.'}, {'ForeName': 'Amanda K', 'Initials': 'AK', 'LastName': 'Rounds', 'Affiliation': 'MedStar National Rehabilitation Hospital, Washington, DC.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Davis', 'Affiliation': 'MedStar National Rehabilitation Hospital, Washington, DC.'}, {'ForeName': 'Inger H', 'Initials': 'IH', 'LastName': 'Ljungberg', 'Affiliation': 'MedStar National Rehabilitation Hospital, Washington, DC.'}, {'ForeName': 'Manon M', 'Initials': 'MM', 'LastName': 'Schladen', 'Affiliation': 'Department of Rehabilitation Medicine, Georgetown University Medical Center, Washington, D.C.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12470']
2643,32798329,Evaluation of a psychoeducational intervention compared with education in people with Parkinson's disease and their informal caregivers: a quasi-experimental study.,"AIM


To evaluate the effects of a psychoeducational intervention compared with an education programme to strengthen quality of life, psychosocial adjustment, and coping in people with Parkinson's disease and their informal caregivers.
DESIGN


A quasi-experimental study was performed with repeated measures at baseline, after the intervention and 6 months post-intervention.
METHODS


The study was carried out at seven primary care centres from 2015-2017. A total of 140 people with Parkinson's and 127 informal caregivers were allocated to the experimental and the control groups. The experimental group received a 9-week psychoeducational intervention, whereas the control group received a 5-week education programme. Repeated measures ANOVA were used to test differences in quality of life, psychosocial adjustment, and coping between the experimental and control groups and over time.
RESULTS


Patients and informal caregivers in both the experimental and control groups showed significantly better psychosocial adjustment at the post-intervention measurement compared with baseline data. We also found significantly greater quality of life in patients and coping skills in caregivers after the end of the interventions in the experimental and control groups. Nevertheless, no significant differences were identified on the outcomes at the 6-month post-intervention measurement.
CONCLUSION


The effect of the psychoeducational intervention was not different from the effect of the education programme. The strategies applied in both interventions followed a group approach led by a multidisciplinary team covering information about PD, healthy lifestyles, and social resources. They might be easily sustained in Primary Care to improve care for people with Parkinson's and informal caregivers.",2020,"RESULTS


Patients and informal caregivers in both the experimental and control groups showed significantly better psychosocial adjustment at the post-intervention measurement compared with baseline data.","[""people with Parkinson's disease and their informal caregivers"", ""people with Parkinson's and informal caregivers"", ""140 people with Parkinson's and 127 informal caregivers"", 'seven primary care centres from 2015-2017']","['control group received a 5-week education programme', '9-week psychoeducational intervention', 'psychoeducational intervention', 'education programme']","['quality of life', 'psychosocial adjustment', 'quality of life, psychosocial adjustment, and coping']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]",140.0,0.0206952,"RESULTS


Patients and informal caregivers in both the experimental and control groups showed significantly better psychosocial adjustment at the post-intervention measurement compared with baseline data.","[{'ForeName': 'María Victoria', 'Initials': 'MV', 'LastName': 'Navarta-Sánchez', 'Affiliation': 'Department of Nursing, Faculty of Medicine, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Leire', 'Initials': 'L', 'LastName': 'Ambrosio', 'Affiliation': 'Faculty of Nursing, University of Navarre, Pamplona, Navarre, Spain.'}, {'ForeName': 'Mari Carmen', 'Initials': 'MC', 'LastName': 'Portillo', 'Affiliation': 'Faculty of Health Sciences, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Maria Eugenia', 'Initials': 'ME', 'LastName': 'Ursúa', 'Affiliation': 'Primary Health Care Center of San Juan, Navarre Health Service, Pamplona, Navarre, Spain.'}, {'ForeName': 'Juana M', 'Initials': 'JM', 'LastName': 'Senosiain', 'Affiliation': 'Faculty of Nursing, University of Navarre, Pamplona, Navarre, Spain.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Riverol', 'Affiliation': 'Department of Neurology, University of Navarra Clinic, Pamplona, Navarre, Spain.'}]",Journal of advanced nursing,['10.1111/jan.14476']
2644,32797776,Comparative Efficacy of Histrelin Acetate and hCG for Inducing Ovulation in Brazilian Northeastern Jennies (Equus africanus asinus).,"The goal of this study was to compare the efficiency of histrelin acetate (GnRH analog) and human chorionic gonadotropin (hCG) to hasten ovulation in Brazilian Northeastern jennies (Equus africanus asinus). Thirty cycles of ten jennies were randomly assigned in one of the three groups: G0 (control group), saline; G1, 250 μg of histrelin acetate; G2, 2500 IU of hCG. Jennies were evaluated by transrectal palpation and ultrasonography, and had the administration of an ovulation-inducing agent when a follicle measuring between 29 and 32 mm of diameter was diagnosed. Jennies were monitored every 6 hours by transrectal ultrasonography until ovulation. The interval between prostaglandin administration and ovulation was lower (P < .05) in jennies from the G1 (145.2 ± 34.6 hours) and G2 (147.4 ± 27.3 hours) groups compared with the control cycle (220.0 ± 41.8 hours). Both treatments (G1, 41.15 ± 3.5 hours; G2, 37.8 ± 2.5 hours) also reduced (P < .05) the interval that jennies took to ovulate after the administration of the ovulation-inducing agent compared with the control (81.8 ± 28.8 hours). All jennies from G1 and G2 ovulated up to 48 hours after ovulation induction, whereas 100% of jennies in the control cycle ovulated later (>48 hours from the administration of saline). In conclusion, both histrelin acetate and hCG at the used dose are efficient ovulation-inducing agents in jennies promoting ovulation up to 48 hours after administration.",2020,The interval between prostaglandin administration and ovulation was lower (P < .05) in jennies from the G1 (145.2 ± 34.6 hours) and G2 (147.4 ± 27.3 hours) groups compared with the control cycle (220.0 ± 41.8 hours).,"['Brazilian Northeastern Jennies (Equus africanus asinus', 'Thirty cycles of ten jennies']","['histrelin acetate (GnRH analog) and human chorionic gonadotropin (hCG', 'histrelin acetate and hCG', 'G0 (control group), saline; G1, 250\xa0μg of histrelin acetate; G2, 2500 IU of hCG', 'Histrelin Acetate and hCG']",['interval between prostaglandin administration and ovulation'],"[{'cui': 'C1265527', 'cui_str': 'Genus Equus'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0724597', 'cui_str': 'Histrelin acetate'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C4319601', 'cui_str': '2500'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}]",,0.0674374,The interval between prostaglandin administration and ovulation was lower (P < .05) in jennies from the G1 (145.2 ± 34.6 hours) and G2 (147.4 ± 27.3 hours) groups compared with the control cycle (220.0 ± 41.8 hours).,"[{'ForeName': 'Sidnei N', 'Initials': 'SN', 'LastName': 'Oliveira', 'Affiliation': 'Sao Paulo State University (Unesp), School of Veterinary Medicine and Animal Science, Botucatu, Brazil. Electronic address: sidneino@gmail.com.'}, {'ForeName': 'Lorenzo G T M', 'Initials': 'LGTM', 'LastName': 'Segabinazzi', 'Affiliation': 'Sao Paulo State University (Unesp), School of Veterinary Medicine and Animal Science, Botucatu, Brazil.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Canuto', 'Affiliation': 'Sao Paulo State University (Unesp), School of Veterinary Medicine and Animal Science, Botucatu, Brazil.'}, {'ForeName': 'Fernando P', 'Initials': 'FP', 'LastName': 'Lisboa', 'Affiliation': 'Caxias do Sul University, Caxias do Sul, RS, Brazil.'}, {'ForeName': 'Felipe E', 'Initials': 'FE', 'LastName': 'Medrado', 'Affiliation': 'Sao Paulo State University (Unesp), School of Veterinary Medicine and Animal Science, Botucatu, Brazil.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': ""Dell'Aqua"", 'Affiliation': 'Sao Paulo State University (Unesp), School of Veterinary Medicine and Animal Science, Botucatu, Brazil.'}, {'ForeName': 'Antonio J A', 'Initials': 'AJA', 'LastName': 'Aguiar', 'Affiliation': 'Sao Paulo State University (Unesp), School of Veterinary Medicine and Animal Science, Botucatu, Brazil.'}, {'ForeName': 'Frederico O', 'Initials': 'FO', 'LastName': 'Papa', 'Affiliation': 'Sao Paulo State University (Unesp), School of Veterinary Medicine and Animal Science, Botucatu, Brazil.'}]",Journal of equine veterinary science,['10.1016/j.jevs.2020.103146']
2645,32798022,Resection following concurrent chemotherapy and high-dose radiation for stage IIIA non-small cell lung cancer.,"OBJECTIVE


Concern exists regarding surgery after thoracic radiation. We aimed to assess early results of anatomic resection following induction therapy with platinum-based chemotherapy and full-dose thoracic radiation for resectable N2+ stage IIIA non-small cell lung cancer.
METHODS


Two prospective trials were recently conducted by NRG Oncology in patients with resectable N2+ stage IIIA non-small cell lung cancer with the primary end point of mediastinal node sterilization following concurrent full-dose chemoradiotherapy (Radiation Therapy Oncology Group trials 0229 and 0839). All surgeons demonstrated postinduction resection expertise. Induction consisted of weekly carboplatin (area under the curve, 2.0) and paclitaxel (50 mg/m 2 ) and concurrent thoracic radiation 60 Gy (0839)/61.2 Gy (0229) in 30 fractions. Patients in study 0839 were randomized 2:1 to weekly panitumumab + chemoradiotherapy or chemoradiotherapy alone during induction. Primary results were similar in all treatment arms and reported previously. Short-term surgical outcomes are reported here.
RESULTS


One hundred twenty-six patients enrolled; 93 (74%) had anatomic resection, 77 underwent lobectomy, and 16 underwent extended resection. Microscopically margin-negative resections occurred in 85 (91%). Fourteen (15%) resections were attempted minimally invasively, including 2 converted without event. Grade 3 or 4 surgical adverse events were reported in 26 (28%), 30-day mortality in 4 (4%) and 90-day mortality in 5 (5%). Patients undergoing extended resection experienced similar rates of grade 3 or 4 adverse events (odds ratio, 0.95; 95% confidence interval, 0.42-3.8) but higher 30-day (1.3% vs 18.8%) (odds ratio, 17.54; 95% confidence interval, 1.75-181.8) and 90-day mortality (2.6% vs 18.8%) (odds ratio, 8.65; 95% confidence interval, 1.3-56.9).
CONCLUSIONS


Lobectomy was performed safely following full-dose concurrent chemoradiotherapy in these multi-institutional prospective trials; however, increased mortality was noted with extended resections.",2020,"Patients undergoing extended resection experienced similar rates of grade 3 or 4 adverse events (odds ratio, 0.95; 95% confidence interval, 0.42-3.8) but higher 30-day (1.3% vs 18.8%) (odds ratio, 17.54; 95% confidence interval, 1.75-181.8) and 90-day mortality (2.6% vs 18.8%) (odds ratio, 8.65; 95% confidence interval, 1.3-56.9).
","['patients with resectable N2+ stage IIIA non-small cell lung cancer with the primary end point of mediastinal node sterilization following concurrent full-dose chemoradiotherapy (Radiation Therapy Oncology Group trials 0229 and 0839', 'One hundred twenty-six patients enrolled; 93 (74%) had anatomic resection, 77 underwent lobectomy, and 16 underwent extended resection', 'stage IIIA non-small cell lung cancer']","['anatomic resection following induction therapy with platinum-based chemotherapy and full-dose thoracic radiation', 'paclitaxel', 'carboplatin', 'concurrent chemotherapy and high-dose radiation', 'panitumumab\xa0+\xa0chemoradiotherapy or chemoradiotherapy']","['90-day mortality', 'Microscopically margin-negative resections', 'rates of grade 3 or 4 adverse events', 'mortality', '30-day mortality', 'Grade 3 or 4 surgical adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278983', 'cui_str': 'Non-small cell lung cancer stage IIIA'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0588055', 'cui_str': 'Mediastinal lymph node group'}, {'cui': 'C0038280', 'cui_str': 'Sterilization'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",839.0,0.482473,"Patients undergoing extended resection experienced similar rates of grade 3 or 4 adverse events (odds ratio, 0.95; 95% confidence interval, 0.42-3.8) but higher 30-day (1.3% vs 18.8%) (odds ratio, 17.54; 95% confidence interval, 1.75-181.8) and 90-day mortality (2.6% vs 18.8%) (odds ratio, 8.65; 95% confidence interval, 1.3-56.9).
","[{'ForeName': 'Jessica S', 'Initials': 'JS', 'LastName': 'Donington', 'Affiliation': 'Department of Department of Surgery, University of Chicago Medicine and Biologic Sciences, Chicago, Ill. Electronic address: jdonington@uchicago.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Paulus', 'Affiliation': 'Department of Department of Surgery, University of Chicago Medicine and Biologic Sciences, Chicago, Ill.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Edelman', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, University of Maryland Medical Center, Baltimore, Md.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Krasna', 'Affiliation': 'Department of Surgery, Jersey Shore University Medical Center, Neptune City, NJ.'}, {'ForeName': 'Quynh-Thu', 'Initials': 'QT', 'LastName': 'Le', 'Affiliation': 'Department of Radiation Oncology, Stanford Cancer Institute, Stanford, Calif.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Suntharalingam', 'Affiliation': 'Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, Md.'}, {'ForeName': 'Billy W', 'Initials': 'BW', 'LastName': 'Loo', 'Affiliation': 'Department of Radiation Oncology, Stanford Cancer Institute, Stanford, Calif.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, Pa; Division of Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Bradley', 'Affiliation': 'Department of Radiation Oncology, Winship Cancer Institute, Emory University, Atlanta, Ga.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2020.03.171']
2646,32786187,Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia.,"BACKGROUND


Older patients with acute myeloid leukemia (AML) have a dismal prognosis, even after treatment with a hypomethylating agent. Azacitidine added to venetoclax had promising efficacy in a previous phase 1b study.
METHODS


We randomly assigned previously untreated patients with confirmed AML who were ineligible for standard induction therapy because of coexisting conditions, because they were 75 years of age or older, or both to azacitidine plus either venetoclax or placebo. All patients received a standard dose of azacitidine (75 mg per square meter of body-surface area subcutaneously or intravenously on days 1 through 7 every 28-day cycle); venetoclax (target dose, 400 mg) or matching placebo was administered orally, once daily, in 28-day cycles. The primary end point was overall survival.
RESULTS


The intention-to-treat population included 431 patients (286 in the azacitidine-venetoclax group and 145 in the azacitidine-placebo [control] group). The median age was 76 years in both groups (range, 49 to 91). At a median follow-up of 20.5 months, the median overall survival was 14.7 months in the azacitidine-venetoclax group and 9.6 months in the control group (hazard ratio for death, 0.66; 95% confidence interval, 0.52 to 0.85; P<0.001). The incidence of complete remission was higher with azacitidine-venetoclax than with the control regimen (36.7% vs. 17.9%; P<0.001), as was the composite complete remission (complete remission or complete remission with incomplete hematologic recovery) (66.4% vs. 28.3%; P<0.001). Key adverse events included nausea of any grade (in 44% of the patients in the azacitidine-venetoclax group and 35% of those in the control group) and grade 3 or higher thrombocytopenia (in 45% and 38%, respectively), neutropenia (in 42% and 28%), and febrile neutropenia (in 42% and 19%). Infections of any grade occurred in 85% of the patients in the azacitidine-venetoclax group and 67% of those in the control group, and serious adverse events occurred in 83% and 73%, respectively.
CONCLUSIONS


In previously untreated patients who were ineligible for intensive chemotherapy, overall survival was longer and the incidence of remission was higher among patients who received azacitidine plus venetoclax than among those who received azacitidine alone. The incidence of febrile neutropenia was higher in the venetoclax-azacitidine group than in the control group. (Funded by AbbVie and Genentech; VIALE-A ClinicalTrials.gov number, NCT02993523.).",2020,The incidence of febrile neutropenia was higher in the venetoclax-azacitidine group than in the control group.,"['Previously Untreated Acute Myeloid Leukemia', 'untreated patients with confirmed AML who were ineligible for standard induction therapy because of coexisting conditions, because they were 75 years of age or older, or both to', 'Older patients with acute myeloid leukemia (AML', 'The median age was 76 years in both groups (range, 49 to 91', '431 patients (286 in the azacitidine-venetoclax group and 145 in the']","['azacitidine plus venetoclax', 'azacitidine', 'venetoclax (target dose, 400 mg) or matching placebo', 'Azacitidine', 'venetoclax', 'Azacitidine and Venetoclax', 'azacitidine-venetoclax', 'azacitidine-placebo [control', 'venetoclax-azacitidine', 'azacitidine plus either venetoclax or placebo']","['incidence of complete remission', 'febrile neutropenia', 'neutropenia', 'Infections of any grade', 'overall survival', 'incidence of febrile neutropenia', 'serious adverse events', 'median overall survival', 'nausea of any grade', 'grade 3 or higher thrombocytopenia', 'incidence of remission', 'composite complete remission (complete remission or complete remission with incomplete hematologic recovery']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0004475', 'cui_str': 'Azacitidine'}, {'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C4517577', 'cui_str': '145'}]","[{'cui': 'C0004475', 'cui_str': 'Azacitidine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}]",431.0,0.348327,The incidence of febrile neutropenia was higher in the venetoclax-azacitidine group than in the control group.,"[{'ForeName': 'Courtney D', 'Initials': 'CD', 'LastName': 'DiNardo', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Jonas', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Pullarkat', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Thirman', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Jacqueline S', 'Initials': 'JS', 'LastName': 'Garcia', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Wei', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Konopleva', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Letai', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Fenaux', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Koller', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Violaine', 'Initials': 'V', 'LastName': 'Havelange', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Leber', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Esteve', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Jianxiang', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Vlatko', 'Initials': 'V', 'LastName': 'Pejsa', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hájek', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Porkka', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Árpád', 'Initials': 'Á', 'LastName': 'Illés', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lavie', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Roberto M', 'Initials': 'RM', 'LastName': 'Lemoli', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Kazuhito', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Sung-Soo', 'Initials': 'SS', 'LastName': 'Yoon', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Jun-Ho', 'Initials': 'JH', 'LastName': 'Jang', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Su-Peng', 'Initials': 'SP', 'LastName': 'Yeh', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Turgut', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Wan-Jen', 'Initials': 'WJ', 'LastName': 'Hong', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Jalaja', 'Initials': 'J', 'LastName': 'Potluri', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Keith W', 'Initials': 'KW', 'LastName': 'Pratz', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}]",The New England journal of medicine,['10.1056/NEJMoa2012971']
2647,32787352,Evaluation of the effects of applying the ventricular care bundle (VCB) method for reducing ventilator-associated pneumonia (VAP) in the intensive care unit of a general Chinese tertiary hospital.,"BACKGROUND


Ventilator-associated pneumonia (VAP) is a severe complication that occurs within patients who must use ventilators in the intensive care unit (ICU). Ventilator care bundles (VCB) have been applied across many developed regions and have produced positive results in controlling VAP. In this study, we report on the implementation and effects of using VCBs to manage VAP in a general tertiary hospital in the Inner Mongolia Autonomous Region of China.
METHODS


A targeted surveillance method was used to survey all the patients (n=4,716) in the ICU from June 1, 2017 to May 31, 2019. Patients from June 1, 2017 to May 31, 2018, and June 1, 2018, to May 31, 2019, were respectively divided into 2 groups: the control group (2,029 patients) and intervention group (2,687 patients). These dates were selected because VCB was implemented from June 1, 2018, in our institution. The variables that were associated with VCB and observed were the head-of-bed elevation, oral care, maintenance of the pressure for the cuff of the endotracheal tube, aspiration of subglottic secretion, daily sedation vacation protocol, daily extubation assessment results, and hand hygiene. After collecting the data, the compliance of VCB, ventilator use ratio, and the incidence rate of VAP in these 2 groups were compared.
RESULTS


We observed that compliance with all of the intervention measures for VCB improved results in the intervention group compared to the control. Furthermore, the compliance rate of hand hygiene increased from 71.99% to 91.97%, and the head-of-bed elevation of 30°-45° increased from 62.02% to 85.96%. All differences between these two groups were statistically significant, according to the χ 2 -test. The ventilator use ratio was statistically and significantly lower in the intervention group (34.86%) compared to the control group (40.29%) (χ 2 =95.513, P<0.001). The incidence rate of VAP was statistically and significantly lower in the intervention group (13.70‰) compared to the control group (18.85‰) (χ 2 =5.471, P=0.019).
CONCLUSIONS


Our results show that VCB prevents VAP. Therefore, personnel training, clinical supervision, and surveillance feedback could promote a reduction in intervention measures.",2020,The ventilator use ratio was statistically and significantly lower in the intervention group (34.86%) compared to the control group (40.29%),"['ventilator-associated pneumonia (VAP) in the intensive care unit of a general Chinese tertiary hospital', 'Patients from June 1, 2017 to May 31, 2018, and June 1, 2018, to May 31, 2019, were respectively divided into 2 groups: the control group (2,029 patients) and intervention group (2,687 patients', 'patients (n=4,716) in the ICU from June 1, 2017 to May 31, 2019', 'general tertiary hospital in the Inner Mongolia Autonomous Region of China', 'patients who must use ventilators in the intensive care unit (ICU']","['VCBs', 'VCB', 'ventricular care bundle (VCB) method', 'Ventilator care bundles (VCB']","['compliance rate of hand hygiene', 'head-of-bed elevation, oral care, maintenance of the pressure for the cuff of the endotracheal tube, aspiration of subglottic secretion, daily sedation vacation protocol, daily extubation assessment results, and hand hygiene', 'incidence rate of VAP', 'ventilator use ratio', 'compliance of VCB, ventilator use ratio, and the incidence rate of VAP']","[{'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021515', 'cui_str': 'Inner Mongolia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0184634', 'cui_str': 'Ventilator care'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C3658308', 'cui_str': 'Care Bundles'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0184634', 'cui_str': 'Ventilator care'}]",,0.0316688,The ventilator use ratio was statistically and significantly lower in the intervention group (34.86%) compared to the control group (40.29%),"[{'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Yongfang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Yueying', 'Initials': 'Y', 'LastName': 'Jiao', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Yunting', 'Initials': 'Y', 'LastName': 'Hai', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Haoxue', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Xing', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Binbin', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Bai', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Bao', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Ren', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Huijun', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Junwei', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Tianhui', 'Initials': 'T', 'LastName': 'Guo', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China. tianhui0409@126.com.""}]",Annals of palliative medicine,['10.21037/apm-20-289']
2648,32787361,Effects of the prolong life with nine turn method (Yan Nian Jiu Zhuan) Qigong on patients with chronic fatigue syndrome: study protocol for a randomized controlled trial.,"BACKGROUND


Chronic fatigue syndrome (CFS) is characterized by persistent fatigue, which often leads to physical and psychological damage. Cognitive behavioral therapy (CBT) is considered to be one of the most effective treatments. Prolong life with nine turn method (PLWNT) Qigong is a combination of complex two-way traffic path connecting the cognitive center and the enteric nerves. In this study protocol, we will explore the effectiveness of PLWNT for physical and mental fatigue, gastrointestinal function, depression, and sleep quality in patients with CFS using clinical effectiveness scales and functional magnetic imaging (fMRI).
METHODS


A randomized controlled trial (RCT) consisting of 90 patients will be divided into a CBT and PLWNT group. Both of the groups will include a supervised intervention at the Shanghai University of Traditional Chinese Medicine once a week, and the remaining six days will be completed at home over 12 consecutive weeks. The primary outcome variable will be the Multidimensional Fatigue Inventory (MFI20). Secondary outcomes will evaluate the Short Form 36-item Health Survey (SF-36), the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression Scale (HADS), and brain activation will be explored using fMRI.
RESULTS


This will be the first randomized controlled clinical trial to introduce the PLWNT method for the treatment of CFS. If these results demonstrate that CBT or PLWNT interventions are effective, they will provide a quality treatment plan for patients with chronic fatigue and optimize their guidance.
TRIAL REGISTRATION


Clinical Trials Registry, NCT03496961, Registered on April 12, 2018.",2020,"Secondary outcomes will evaluate the Short Form 36-item Health Survey (SF-36), the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression Scale (HADS), and brain activation will be explored using fMRI.
","['patients with CFS', 'patients with chronic fatigue syndrome', '90 patients', 'patients with chronic fatigue and optimize their guidance', 'Chronic fatigue syndrome (CFS']","['Qigong', 'CBT or PLWNT interventions', 'CBT and PLWNT', 'nine turn method (Yan Nian Jiu Zhuan', 'functional magnetic imaging (fMRI', 'Cognitive behavioral therapy (CBT', 'nine turn method (PLWNT']","['physical and mental fatigue, gastrointestinal function, depression, and sleep quality', 'Multidimensional Fatigue Inventory (MFI20', 'Short Form 36-item Health Survey (SF-36), the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression Scale (HADS), and brain activation will be explored using fMRI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C0518656', 'cui_str': 'Chronic fatigue'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0044523', 'cui_str': '1-nitrosoindole-3-acetonitrile'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]",90.0,0.127951,"Secondary outcomes will evaluate the Short Form 36-item Health Survey (SF-36), the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression Scale (HADS), and brain activation will be explored using fMRI.
","[{'ForeName': 'Fangfang', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Guan', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Ziji', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Yao', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China. doctoryaofei@126.com.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': 'Department of Traditional Chinese Medicine, Changhai Hospital, Naval Medical University, Shanghai, China. youyanli2005@163.com.'}]",Annals of palliative medicine,['10.21037/apm-19-461']
2649,32795381,Health TAPESTRY Ontario: protocol for a randomized controlled trial to test reproducibility and implementation.,"BACKGROUND


Health TAPESTRY (Health Teams Advancing Patient Experience: STRengthening qualitY) aims to help people stay healthier for longer where they live by providing person-focused care through the integration of four key program components: (1) trained volunteers who visit clients in their homes, (2) an interprofessional primary health care team, (3) use of technology to collect and share information, and (4) improved connections to community health and social services. The initial randomized controlled trial of Health TAPESTRY found promising results in terms of health care use and patient outcomes, indicating a shift from reactive to preventive care. The trial was based on one clinical academic center, thus limiting generalizability. The study objectives are (1) to test reproducibility of the established effectiveness of Health TAPESTRY on physical activity and hospitalizations, (2) to test the feasibility of, and understand the contributing factors to, the implementation of Health TAPESTRY in six diverse communities across Ontario, Canada, and (3) to determine the value for money of implementing Health TAPESTRY.
METHODS


This planned study is a pragmatic parallel randomized controlled trial with a delayed intervention for control participants at 6 months. This trial will simultaneously assess effectiveness and implementation in a real-world setting (type II hybrid) in six diverse communities across Ontario. Participants 70 years of age and older will be randomized into the Health TAPESTRY intervention or the control group (usual care). Intervention clients will receive an individualized plan of care from an interprofessional care team. The plan will be based on a client's goals and current health risks identified through volunteer visits. The study's outcomes are mapped onto the RE-AIM framework, with levels of physical activity and number of hospitalizations as the co-primary outcomes. The main analysis will be a comparison at 6 months.
DISCUSSION


It is important to evaluate the effectiveness and implementation of Health TAPESTRY in multiple communities prior to scaling or widespread adoption.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03397836 . Registered on 12 January 2018.",2020,Participants 70 years of age and older will be randomized into the Health TAPESTRY intervention or the control group (usual care).,"['Participants 70\u2009years of age and older', 'control participants at 6\xa0months', 'Health Teams Advancing Patient Experience', 'six diverse communities across Ontario']","['interprofessional primary health care team, (3) use of technology to collect and share information, and (4) improved connections to community health and social services', 'Health TAPESTRY', 'Health TAPESTRY intervention or the control group (usual care']",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.108994,Participants 70 years of age and older will be randomized into the Health TAPESTRY intervention or the control group (usual care).,"[{'ForeName': 'Dee', 'Initials': 'D', 'LastName': 'Mangin', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 100 Main Street West, 5th floor, Hamilton, ON, L8P 1H6, Canada. mangind@mcmaster.ca.'}, {'ForeName': 'Larkin', 'Initials': 'L', 'LastName': 'Lamarche', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 100 Main Street West, 5th floor, Hamilton, ON, L8P 1H6, Canada.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Oliver', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 100 Main Street West, 3rd floor, Hamilton, ON, L8P 1H6, Canada.'}, {'ForeName': 'Sivan', 'Initials': 'S', 'LastName': 'Bomze', 'Affiliation': 'Canadian Red Cross, 5700 Cancross Court, Mississauga, ON, L5R 3E9, Canada.'}, {'ForeName': 'Sayem', 'Initials': 'S', 'LastName': 'Borhan', 'Affiliation': 'Department of Family Medicine, and Department of Health Research Methods, Evidence and Impact McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4L8, Canada.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Browne', 'Affiliation': 'Canadian Red Cross, 1460 Fairburn Street, Sudbury, ON, P3A 1N7, Canada.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Carr', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 100 Main Street West, 6th floor, Hamilton, ON, L8P 1H6, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Datta', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 100 Main Street West, 6th floor, Hamilton, ON, L8P 1H6, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Dolovich', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 100 Main Street West, 5th floor, Hamilton, ON, L8P 1H6, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Howard', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 100 Main Street West, 5th floor, Hamilton, ON, L8P 1H6, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Marentette-Brown', 'Affiliation': 'Canadian Red Cross, 5700 Cancross Court, Mississauga, ON, L5R 3E9, Canada.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Risdon', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 100 Main Street West, 6th floor, Hamilton, ON, L8P 1H6, Canada.'}, {'ForeName': 'Samina', 'Initials': 'S', 'LastName': 'Talat', 'Affiliation': 'Canadian Red Cross, 5700 Cancross Court, Mississauga, ON, L5R 3E9, Canada.'}, {'ForeName': 'Jean-Eric', 'Initials': 'JE', 'LastName': 'Tarride', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Programs for Assessment of Technologies in Health and Center for Health Economics and Policy Analysis, CRL 227, 1280 Main Street West, Hamilton, ON, L8S 4L8, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Programs for Assessment of Technologist in Health, 1280 Main Street West, Hamilton, ON, L8S 4L8, Canada.'}, {'ForeName': 'Ruta', 'Initials': 'R', 'LastName': 'Valaitis', 'Affiliation': 'School of Nursing, McMaster University, Health Sciences Centre, 1280 Main Street West, Hamilton, ON, L8S 4L8, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Price', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 100 Main Street West, 6th floor, Hamilton, ON, L8P 1H6, Canada.'}]",Trials,['10.1186/s13063-020-04600-y']
2650,32795428,Levonorgestrel releasing intrauterine system versus endometrial ablation for heavy menstrual bleeding.,"BACKGROUND


Heavy menstrual bleeding affects the physical functioning and social well-being of many women. The levonorgestrel intrauterine system and endometrial ablation are two frequently applied treatments in women with heavy menstrual bleeding.
OBJECTIVE


The objective of this study is to compare the effectiveness of the levonorgestrel intrauterine system to endometrial ablation in women with heavy menstrual bleeding.
STUDY DESIGN


This multicenter randomized controlled non-inferiority trial was performed in 26 hospitals and in a network of general practices in the Netherlands. Women with heavy menstrual bleeding, aged 34 and older, without a pregnancy wish or intracavitary pathology were randomly allocated to treatment with either the levonorgestrel intrauterine system (Mirena) or to endometrial ablation, performed with the bipolar radiofrequency device (NovaSure). The primary outcome was blood loss at 24 months, measured with a Pictorial Blood Assessment Chart (PBAC)-score. Secondary outcomes included re-intervention rates, patient satisfaction, quality of life, and sexual function.
RESULTS


We registered 645 women as eligible of whom 270 women provided informed consent. Of these, 132 women were allocated to the levonorgestrel intrauterine system (baseline PBAC-score 616) and 138 women to endometrial ablation (baseline PBAC-score 630). At 24 months, mean PBAC-scores were 64.8 in the levonorgestrel intrauterine system group and 14.2 in the endometrial ablation group (difference 50.5 points, 95% CI 4.3 to 96.7, non-inferiority P=0.87 (25 PBAC-points margin)). In the levonorgestrel intrauterine system group 49 women (39%) removed the intrauterine system and 34 women (27%) underwent a surgical re-intervention, compared to 14 women (10%) in the endometrial ablation group (RR 2.64, 95% CI 1.49 to 4.68). There was no significant difference in patient satisfaction and quality of life between the groups.
CONCLUSIONS


Both the levonorgestrel intrauterine system and endometrial ablation strategy lead to a large decrease in menstrual blood loss in women with heavy menstrual bleeding, with comparable quality of life scores after treatment. Nevertheless, there was a significant difference in menstrual blood loss in favor of endometrial ablation, and we could not demonstrate non-inferiority of starting with the levonorgestrel intrauterine system. Women who start with the levonorgestrel intrauterine system, a reversible and less invasive treatment, are at increased risk of needing additional treatment, compared to women who start with endometrial ablation. The results of this study will enable physicians to provide women with heavy menstrual bleeding with the evidence to make a well-informed decision between the two treatments.",2020,"At 24 months, mean PBAC-scores were 64.8 in the levonorgestrel intrauterine system group and 14.2 in the endometrial ablation group (difference 50.5 points, 95% CI 4.3 to 96.7, non-inferiority P=0.87 (25 PBAC-points margin)).","['women with heavy menstrual bleeding', 'heavy menstrual bleeding', 'Women with heavy menstrual bleeding, aged 34 and older, without a pregnancy wish or intracavitary pathology', '132 women were allocated to the levonorgestrel intrauterine system (baseline PBAC-score 616) and 138 women to endometrial ablation (baseline PBAC-score 630', '645 women as eligible of whom 270 women provided informed consent', '26 hospitals and in a network of general practices in the Netherlands', 'Women who start with the levonorgestrel intrauterine system, a reversible and less invasive treatment']","['levonorgestrel intrauterine system', 'levonorgestrel intrauterine system (Mirena) or to endometrial ablation, performed with the bipolar radiofrequency device (NovaSure', 'levonorgestrel intrauterine system and endometrial ablation', 'Levonorgestrel releasing intrauterine system versus endometrial ablation']","['risk of needing additional treatment', 'mean PBAC-scores', 'menstrual blood loss', 'blood loss at 24 months, measured with a Pictorial Blood Assessment Chart (PBAC)-score', 're-intervention rates, patient satisfaction, quality of life, and sexual function', 'patient satisfaction and quality of life']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025323', 'cui_str': 'Menorrhagia'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1298613', 'cui_str': 'Intracavitary'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C4293465', 'cui_str': 'Levonorgestrel Intrauterine System [Kyleena]'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0341803', 'cui_str': 'Endometrial ablation'}, {'cui': 'C4708165', 'cui_str': '630'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4293465', 'cui_str': 'Levonorgestrel Intrauterine System [Kyleena]'}, {'cui': 'C0341803', 'cui_str': 'Endometrial ablation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4293370', 'cui_str': 'Intrauterine System'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0694689', 'cui_str': 'Menstrual blood'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}]",645.0,0.184613,"At 24 months, mean PBAC-scores were 64.8 in the levonorgestrel intrauterine system group and 14.2 in the endometrial ablation group (difference 50.5 points, 95% CI 4.3 to 96.7, non-inferiority P=0.87 (25 PBAC-points margin)).","[{'ForeName': 'Pleun', 'Initials': 'P', 'LastName': 'Beelen', 'Affiliation': 'Department of Obstetrics and Gynecology, Máxima MC, Veldhoven, the Netherlands; Department of General Practice, University of Maastricht, Maastricht, the Netherlands. Electronic address: pleun.beelen@gmail.com.'}, {'ForeName': 'Marian J', 'Initials': 'MJ', 'LastName': 'VAN DEN Brink', 'Affiliation': 'Department of General Practice & Elderly care medicine, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Malou C', 'Initials': 'MC', 'LastName': 'Herman', 'Affiliation': ""Department of Obstetrics and Gynecology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.""}, {'ForeName': 'Peggy M', 'Initials': 'PM', 'LastName': 'Geomini', 'Affiliation': 'Department of Obstetrics and Gynecology, Máxima MC, Veldhoven, the Netherlands.'}, {'ForeName': 'Janny H', 'Initials': 'JH', 'LastName': 'Dekker', 'Affiliation': 'Department of General Practice & Elderly care medicine, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Ruben G', 'Initials': 'RG', 'LastName': 'Duijnhoven', 'Affiliation': 'Department of Obstetrics and Gynecology, Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'M A K', 'Initials': 'MAK', 'LastName': 'Nienke', 'Affiliation': 'Department of General Practice, University of Maastricht, Maastricht, the Netherlands.'}, {'ForeName': 'Hannah S', 'Initials': 'HS', 'LastName': 'VAN Meurs', 'Affiliation': 'Department of Obstetrics and Gynecology, Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Sjors F', 'Initials': 'SF', 'LastName': 'Coppus', 'Affiliation': 'Department of Obstetrics and Gynecology, Máxima MC, Veldhoven, the Netherlands.'}, {'ForeName': 'Jan Willem', 'Initials': 'JW', 'LastName': 'VAN DER Steeg', 'Affiliation': ""Department of Obstetrics and Gynecology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.""}, {'ForeName': 'Heleen P', 'Initials': 'HP', 'LastName': 'Eising', 'Affiliation': 'Department of Obstetrics and Gynecology, Gelre Hospital, Apeldoorn, the Netherlands.'}, {'ForeName': 'Diana S', 'Initials': 'DS', 'LastName': 'Massop-Helmink', 'Affiliation': 'Department of Obstetrics and Gynecology, Medisch Spectrum Twente, Twente, the Netherlands.'}, {'ForeName': 'Ellen R', 'Initials': 'ER', 'LastName': 'Klinkert', 'Affiliation': 'Department of Obstetrics and Gynecology, University Medical Centre Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Theodoor E', 'Initials': 'TE', 'LastName': 'Nieboer', 'Affiliation': 'Department of Obstetrics and Gynecology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Timmermans', 'Affiliation': 'Department of Obstetrics and Gynecology, Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Lucet F', 'Initials': 'LF', 'LastName': 'VAN DER Voet', 'Affiliation': 'Department of Obstetrics and Gynecology, Deventer Hospital, Deventer, the Netherlands.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Veersema', 'Affiliation': 'Department of Reproductive Medicine and Gynecology, UMC Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Nicol A C', 'Initials': 'NAC', 'LastName': 'Smeets', 'Affiliation': 'Department of Obstetrics and Gynecology, Zuyderland Medical Centre, Heerlen, the Netherlands.'}, {'ForeName': 'Joke M', 'Initials': 'JM', 'LastName': 'Schutte', 'Affiliation': 'Department of Obstetrics and Gynecology, Isala Hospital, Zwolle, the Netherlands.'}, {'ForeName': 'Marchien', 'Initials': 'M', 'LastName': 'VAN Baal', 'Affiliation': 'Department of Obstetrics and Gynecology, Flevo Hospital, Almere, the Netherlands.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Bossuyt', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Ben Willem J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynecology, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Marjolein Y', 'Initials': 'MY', 'LastName': 'Berger', 'Affiliation': 'Department of General Practice & Elderly care medicine, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Marlies Y', 'Initials': 'MY', 'LastName': 'Bongers', 'Affiliation': 'Department of Obstetrics and Gynecology, Máxima MC, Veldhoven, the Netherlands; Research School Grow, University of Maastricht, Maastricht, the Netherlands.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.08.016']
2651,32795561,Comparative effect of Liuzijue Qigong and conventional respiratory training on trunk control ability and respiratory muscle function in patients at an early recovery stage from stroke: a randomized controlled trial.,"OBJECTIVE


To compare the effects of Liuzijue Qigong and conventional respiratory training on trunk control ability and respiratory muscle functions in patients at an early recovery stage from stroke.
DESIGN


A single-blind, randomized controlled trial.
SETTING


A hospital PARTICIPANTS: 60 patients within 2 months post-stroke.
INTERVENTIONS


The experimental group (N=30) received conventional rehabilitation training combined with Liuzijue exercise, the control group (N=30) received conventional rehabilitation training combined with conventional respiration training. The training in the 2 groups was conducted 5 times per week for 3 weeks.
MAIN MEASURES


Trunk Impairment Scale (TIS), Maximum Inspiratory Pressure (MIP), Maximum Expiratory Pressure (MEP), Forced Expiratory Volume in the first second (FEV1), Forced Vital Capacity (FVC), Peak Expiratory Flow (PEF), Maximum Expiratory Mid-flow (MMEF), diaphragmatic movement, the change of intra-abdominal pressure (IAP), Berg Balance Scale (BBS) and Modified Barthel Index (MBI). All outcome measures were assessed twice (at baseline and 3 weeks).
RESULTS


Both groups significantly improved in TIS, MIP, FVC, PEF, the change of IAP, BBS and MBI when pre- and post-assessments (P<0.05) were compared. In contrast to the control group, there was a significant difference in the experimental group in the static sitting balance subscale (P=0.014), dynamic balance subscale (P=0.001), coordination subscale (P<0.001), TIS total scores (P<0.001, ES=0.9), MIP (P=0.012, 95% CI 2.23 to 17.69, ES=0.67), MEP (P=0.015, 95% CI 1.85 to 16.57, ES=0.65), the change of IAP (P=0.001), and MBI (P=0.016, 95% CI 1.51 to 14.16, ES=0.64). No significant differences were found between the 2 groups in FEV1 (P=0.24), FVC (P =0.43), PEF (P=0.202), MMEF (P=0.277), the diaphragmatic movement of quiet breathing (P=0.146) and deep breathing (P=0.102), and BBS (P=0.124).
CONCLUSION


The Liuzijue showed more changes than conventional respiratory training in improving trunk control ability, respiratory muscle functions and ADL ability in patients at an early recovery stage from stroke.",2020,"Both groups significantly improved in TIS, MIP, FVC, PEF, the change of IAP, BBS and MBI when pre- and post-assessments (P<0.05) were compared.","[' 60 patients within 2 months post-stroke', 'patients at an early recovery stage from stroke']","['Liuzijue Qigong and conventional respiratory training', 'conventional rehabilitation training combined with Liuzijue exercise, the control group', 'conventional rehabilitation training combined with conventional respiration training', 'conventional respiratory training']","['Trunk Impairment Scale (TIS), Maximum Inspiratory Pressure (MIP), Maximum Expiratory Pressure (MEP), Forced Expiratory Volume in the first second (FEV1), Forced Vital Capacity (FVC), Peak Expiratory Flow (PEF), Maximum Expiratory Mid-flow (MMEF), diaphragmatic movement, the change of intra-abdominal pressure (IAP), Berg Balance Scale (BBS) and Modified Barthel Index (MBI', 'TIS, MIP, FVC, PEF, the change of IAP, BBS and MBI', 'static sitting balance subscale', 'change of IAP', 'dynamic balance subscale', 'PEF', 'diaphragmatic movement of quiet breathing', 'deep breathing', 'trunk control ability and respiratory muscle function', 'MIP', 'BBS', 'MEP', 'trunk control ability, respiratory muscle functions and ADL ability', 'trunk control ability and respiratory muscle functions', 'TIS total scores', 'FEV1', 'coordination subscale', 'MBI', 'FVC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}, {'cui': 'C0232022', 'cui_str': 'Peak expiratory pressure'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0232079', 'cui_str': 'Diaphragmatic movement'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C1321587', 'cui_str': 'Excessively deep breathing'}, {'cui': 'C0426971', 'cui_str': 'Trunk control'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}]",,0.0701272,"Both groups significantly improved in TIS, MIP, FVC, PEF, the change of IAP, BBS and MBI when pre- and post-assessments (P<0.05) were compared.","[{'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China; School of Kinesiology, Shanghai University of Sport, Shanghai, China. Electronic address: ZhangYing032317@163.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China. Electronic address: ZhangYing032317@163.com.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Shanghai Shenyuan Rehabilitation Hospital, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Qiao', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Weijie', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Gaiyan', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Jianzhong', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Ni', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'Yong', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Yanmin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.07.007']
2652,32795562,"Effects of dual-task group training on gait, cognitive executive function and quality of life in people with Parkinson's disease: results of randomized controlled DUALGAIT trial.","OBJECTIVES


This study aims (1) to analyze the effects of a dual-task group program, (2) to compare it with the effects of a single-task group program and, (3) to analyze the effects of functional secondary tasks.
DESIGN


Single-blind randomized controlled trial.
SETTING


University laboratory, rehabilitation gym at health center.
PARTICIPANTS


People (N = 40) with a diagnosis of Parkinson's disease (aged 66.72 [44-79] years, Hoehn and Yahr stage I-II-III and on-medication) were randomized to (1) a group with dual-task training or (2) a group with single-task training (only gait).
INTERVENTION


Both interventions involved 20 one-hour sessions conducted twice a week. Dual-task training included walking exercises and cognitive or motor tasks carried out separately, later performed together as a dual-task according to a progressive protocol in the same training session.
MAIN OUTCOME MEASURES


Velocity and spatiotemporal parameters of gait were measured without a secondary task and during dual-task gait combined with a visual, verbal, auditory and motor task. In addition, Executive cognitive function and Quality of life were measured. Assessment were conducted at baseline, post-rehabilitation, and at 8-weeks follow-up.
RESULTS


Dual-task group improved Velocity, and Stride length time in all assessment conditions after training (p < .05), like their perceived Quality of life (p < .05). Single-task group experienced improvements in the same outcomes only for the motor condition (p < .05) after training, but failed to improve perceived Quality of life (p > .05). Likewise, the dual-task group showed higher Velocity and Stride length after treatment than the single-task group across conditions. No significant changes in cognitive performance were observed (p > .05), although DT group tended to improve performance during the executive function test.
CONCLUSIONS


Dual tasks training in functional contexts is associated with greater improvements in velocity and stride length in patients with PD as compared to regular physiotherapy without secondary tasks, and improves perceived Quality of life.",2020,"Single-task group experienced improvements in the same outcomes only for the motor condition (p < .05) after training, but failed to improve perceived Quality of life (p > .05).","[""People (N = 40) with a diagnosis of Parkinson's disease (aged 66.72"", 'University laboratory, rehabilitation gym at health center', 'patients with PD', '44-79] years, Hoehn and Yahr stage I-II-III and on-medication', ""people with Parkinson's disease""]","['Dual-task training included walking exercises and cognitive or motor tasks carried out separately, later performed together as a dual-task according to a progressive protocol', 'dual-task group training', 'Dual tasks training', 'dual-task training or (2) a group with single-task training (only gait']","['cognitive performance', 'gait, cognitive executive function and quality of life', 'like their perceived Quality of life', 'Velocity, and Stride length time', 'Executive cognitive function and Quality of life', 'motor condition', 'velocity and stride length', 'Velocity and Stride length', 'Velocity and spatiotemporal parameters of gait were measured without a secondary task and during dual-task gait combined with a visual, verbal, auditory and motor task', 'perceived Quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0589089', 'cui_str': 'Executive cognitive functions'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}]",40.0,0.0321115,"Single-task group experienced improvements in the same outcomes only for the motor condition (p < .05) after training, but failed to improve perceived Quality of life (p > .05).","[{'ForeName': 'Constanza', 'Initials': 'C', 'LastName': 'San Martín Valenzuela', 'Affiliation': 'Unit of Personal Autonomy, Dependency and Mental Disorder Assessment, Faculty of Medicine, University of Valencia, Blasco Ibáñez, 15, 46010 Valencia, Spain; Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Gascó Oliag Street, 5, 46010 Valencia, Spain; UBIC Reseach Group, Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Gascó Oliag Street, 5, 46010 Valencia, Spain; Centro Investigación Biomédica en Red de Salud Mental, CIBERSAM, Av. Monforte de Lemos, 3-5, 28029 Madrid Madrid, Spain.'}, {'ForeName': 'Lirios Dueñas', 'Initials': 'LD', 'LastName': 'Moscardó', 'Affiliation': 'Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Gascó Oliag Street, 5, 46010 Valencia, Spain.'}, {'ForeName': 'Juan López', 'Initials': 'JL', 'LastName': 'Pascual', 'Affiliation': 'Biomechanics Institute of Valencia, Polytechnic University of Valencia, Camino de Vera, s/n, 46022 Valencia, Spain.'}, {'ForeName': 'Pilar Serra', 'Initials': 'PS', 'LastName': 'Añó', 'Affiliation': 'Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Gascó Oliag Street, 5, 46010 Valencia, Spain; UBIC Reseach Group, Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Gascó Oliag Street, 5, 46010 Valencia, Spain. Electronic address: pilar.serra@uv.es.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Tomás', 'Affiliation': 'Department of Behavioral Sciences Methodology, Faculty of Psychology, University of Valencia, Blasco Ibánez Avenue, 13, 46010 Valencia, Spain.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.07.008']
2653,32798144,Study protocol for a multi-institutional randomized phase III study comparing combined everolimus plus lanreotide therapy and everolimus monotherapy in patients with unresectable or recurrent gastroenteropancreatic neuroendocrine tumors; Japan Clinical Oncology Group Study JCOG1901 (STARTER-NET study).,"Everolimus is recognized as one of the standard drugs for the treatment of unresectable or recurrent gastroenteropancreatic neuroendocrine tumors (NET). However, recent evidence has suggested that addition of somatostatin analogs to everolimus may yield better survival outcomes as compared to everolimus alone. In April 2020, we have initiated a randomized phase III trial in Japan, to confirm the superiority of combined everolimus plus lanreotide therapy over everolimus monotherapy in patients with unresectable or recurrent gastroenteropancreatic NETs with poor prognostic factors (Ki-67 labeling index: LI 5%-20% or Ki-67 LI < 5% with diffuse liver metastases). We plan to enroll a total of 250 patients from 76 institutions over an accrual period of 5 years. The primary endpoint is progression-free survival. The key secondary endpoint is overall survival, with response rate, disease control rate, and proportion of patients with adverse events as the other secondary endpoints. This trial is registered with the Japan Registry of Clinical Trials as jRCT1031200023 [https://jrct.niph.go.jp/en-latest-detail/jRCT1031200023].",2020,"The key secondary endpoint is overall survival, with response rate, disease control rate, and proportion of patients with adverse events as the other secondary endpoints.","['250 patients from 76 institutions over an accrual period of 5 years', 'patients with unresectable or recurrent gastroenteropancreatic neuroendocrine tumors', 'patients with unresectable or recurrent gastroenteropancreatic NETs with poor prognostic factors (Ki-67 labeling index: LI 5%-20% or Ki-67 LI']","['Everolimus', 'combined everolimus plus lanreotide therapy and everolimus monotherapy', 'combined everolimus plus lanreotide therapy over everolimus monotherapy']","['progression-free survival', 'overall survival, with response rate, disease control rate, and proportion of patients with adverse events']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C2930967', 'cui_str': 'Gastro-enteropancreatic neuroendocrine tumor'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0209211', 'cui_str': 'lanreotide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",250.0,0.0489079,"The key secondary endpoint is overall survival, with response rate, disease control rate, and proportion of patients with adverse events as the other secondary endpoints.","[{'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Shimoyama', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Hijioka', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan. Electronic address: shijioka@ncc.go.jp.'}, {'ForeName': 'Nobumasa', 'Initials': 'N', 'LastName': 'Mizuno', 'Affiliation': 'Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Gakuto', 'Initials': 'G', 'LastName': 'Ogawa', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Kataoka', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Katayama', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Nozomu', 'Initials': 'N', 'LastName': 'Machida', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Honma', 'Affiliation': 'Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Hamaguchi', 'Affiliation': 'Department of Gastroenterological Oncology, Saitama Medical University International Medical Center, Saitama, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Fukuda', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Terashima', 'Affiliation': 'Division of Gastric Surgery, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Yukihide', 'Initials': 'Y', 'LastName': 'Kanemitsu', 'Affiliation': 'Department of Colorectal Surgery, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Furuse', 'Affiliation': 'Department of Medical Oncology, Kyorin University, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.],['10.1016/j.pan.2020.07.010']
2654,32798161,Pain after mandibular ramus block harvesting and lateral ridge augmentation with and without involvement of platelet-rich fibrin: a randomized controlled trial.,"The purpose of this study was to evaluate pain after mandibular ramus block harvesting and lateral ridge augmentation. Autogenous bone block grafts were covered with platelet-rich fibrin (PRF) membranes (test group) or deproteinized bovine bone and a resorbable collagen membrane (control group). This study included 27 partially edentulous patients (test = 14, control = 13) with an indication for bone block augmentation before staged implant placement. Postoperative methylprednisolone (32 mg, day 1) and analgesics comprising ibuprofen (400 mg, four times daily) and paracetamol (1 g, four times daily) were prescribed for 1 week. Pain was recorded by the patient on a 100-mm visual analogue scale (VAS), hourly on the day of surgery and daily for the following 7 days. The average (mean ± standard deviation) maximum pain score over the whole observation period was similar in the test (13.6 ± 13.5) and control (21.0 ± 19.9) groups (P = 0.17). In conclusion, harvesting of a mandibular ramus block and lateral ridge augmentation, in conjunction with the pharmacological protocol described, is characterized by low postoperative pain. Adding PRF membranes to the surgical site generally resulted in slightly lower pain perception, although a statistically significant difference between the test and control groups was only identified on day 1 postoperative.",2020,"Adding PRF membranes to the surgical site generally resulted in slightly lower pain perception, although a statistically significant difference between the test and control groups was only identified on day 1 postoperative.","['27 partially edentulous patients (test\u2009=\u200914, control\u2009=\u200913) with an indication for bone block augmentation before staged implant placement']","['Autogenous bone block grafts', 'paracetamol', 'mandibular ramus block harvesting and lateral ridge augmentation with and without involvement of platelet-rich fibrin', 'Postoperative methylprednisolone', 'platelet-rich fibrin (PRF) membranes (test group) or deproteinized bovine bone and a resorbable collagen membrane (control group', 'analgesics comprising ibuprofen']","['100-mm visual analogue scale (VAS', 'Pain', 'average (mean\u2009±\u2009standard deviation) maximum pain score', 'pain', 'pain perception']","[{'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1293164', 'cui_str': 'Bone block procedure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C1293164', 'cui_str': 'Bone block procedure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0222748', 'cui_str': 'Structure of ramus of mandible'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",27.0,0.0648931,"Adding PRF membranes to the surgical site generally resulted in slightly lower pain perception, although a statistically significant difference between the test and control groups was only identified on day 1 postoperative.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hartlev', 'Affiliation': 'Section for Oral Surgery and Oral Pathology, Department of Dentistry and Oral Health, Health, Aarhus University, Aarhus C, Denmark. Electronic address: jens.hartlev@clin.au.dk.'}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Nørholt', 'Affiliation': 'Section for Oral Surgery and Oral Pathology, Department of Dentistry and Oral Health, Health, Aarhus University, Aarhus C, Denmark; Department of Oral and Maxillofacial Surgery, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Schou', 'Affiliation': 'Department of Periodontology, School of Dentistry, Faculty of Health Sciences, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Isidor', 'Affiliation': 'Section for Prosthetic Dentistry, Department of Dentistry and Oral Health Health, Aarhus University, Aarhus C, Denmark.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2020.07.009']
2655,32798172,"Ultrasound-Guided Pecto-Intercostal Fascial Block for Postoperative Pain Management in Cardiac Surgery: A Prospective, Randomized, Placebo-Controlled Trial.","OBJECTIVE


To explore the effect of pecto-intercostal fascial plane block (PIFB) on postoperative opioid requirements, pain scores, lengths of intensive care unit and hospital stays and incidence of postoperative delirium in cardiac surgical patients.
DESIGN


Single- center, prospective, randomized (1:1), quadruple- blinded, placebo-controlled trial.
SETTING


Single center, tertiary- care center.
PARTICIPANTS


The study comprised 80 adult cardiac surgical patients (age >18 y) requiring median sternotomy.
INTERVENTION


Patients were randomly assigned to receive ultrasound-guided PIFB, with either 0.25% bupivacaine or placebo, on postoperative days 0 and 1.
MEASUREMENTS AND MAIN RESULTS


Of the 80 patients randomized, the mean age was 65.78 ± 8.73 in the bupivacaine group and 65.70 ± 9.86 in the placebo group (p = 0.573). Patients receiving PIFB with 0.25% bupivacaine showed a statistically significant reduction in visual analog scale scores (4.8 ± 2.7 v 5.1 ± 2.6; p < 0.001), but the 48-hour cumulative opioid requirement computed as morphine milligram equivalents was similar (40.8 ± 22.4 mg v 49.1 ± 26.9 mg; p = 0.14). There was no difference in the incidence of postoperative delirium between the groups evaluated using the 3-minute diagnostic Confusion Assessment Method (3/40 [7.5%] v 5/40 [12.5%] placebo; p = 0.45).
CONCLUSION


Patients who received PIFB with bupivacaine showed a decline in cumulative opioid consumption postoperatively, but this difference between the groups was not statistically significant. Low incidence of complications and improvement in visual analog scale pain scores suggested that the PIFB can be performed safely in this population and warrants additional studies with a larger sample size.",2020,"There was no difference in the incidence of postoperative delirium between the groups evaluated using the 3-minute diagnostic Confusion Assessment Method (3/40 [7.5%] v 5/40 [12.5%] placebo; p = 0.45).
","['80 adult cardiac surgical patients (age >18 y) requiring median sternotomy', 'cardiac surgical patients', 'Single center, tertiary- care center', 'Cardiac Surgery']","['Placebo', 'pecto-intercostal fascial plane block (PIFB', 'bupivacaine', 'Ultrasound-Guided Pecto-Intercostal Fascial Block', 'ultrasound-guided PIFB, with either 0.25% bupivacaine or placebo', 'placebo']","['48-hour cumulative opioid requirement computed as morphine milligram equivalents', 'visual analog scale scores', 'incidence of postoperative delirium', 'visual analog scale pain scores', 'postoperative opioid requirements, pain scores, lengths of intensive care unit and hospital stays and incidence of postoperative delirium', 'cumulative opioid consumption']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1282959', 'cui_str': 'Median sternotomy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C4517443', 'cui_str': '0.25'}]","[{'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",80.0,0.679881,"There was no difference in the incidence of postoperative delirium between the groups evaluated using the 3-minute diagnostic Confusion Assessment Method (3/40 [7.5%] v 5/40 [12.5%] placebo; p = 0.45).
","[{'ForeName': 'Tanvi', 'Initials': 'T', 'LastName': 'Khera', 'Affiliation': 'Center for Anesthesia and Research Excellence, Department of Anesthesia Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Kadhiresan R', 'Initials': 'KR', 'LastName': 'Murugappan', 'Affiliation': 'Center for Anesthesia and Research Excellence, Department of Anesthesia Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA.'}, {'ForeName': 'Akiva', 'Initials': 'A', 'LastName': 'Leibowitz', 'Affiliation': 'Center for Anesthesia and Research Excellence, Department of Anesthesia Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA.'}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Bareli', 'Affiliation': 'Clinical Research Center, Soroka University Medical Center, Beer-Sheva, Israel.'}, {'ForeName': 'Puja', 'Initials': 'P', 'LastName': 'Shankar', 'Affiliation': 'Center for Anesthesia and Research Excellence, Department of Anesthesia Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Gilleland', 'Affiliation': 'Center for Anesthesia and Research Excellence, Department of Anesthesia Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': 'Center for Anesthesia and Research Excellence, Department of Anesthesia Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Achikam', 'Initials': 'A', 'LastName': 'Oren-Grinberg', 'Affiliation': 'Center for Anesthesia and Research Excellence, Department of Anesthesia Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Novack', 'Affiliation': 'Center for Anesthesia and Research Excellence, Department of Anesthesia Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Senthilnathan', 'Initials': 'S', 'LastName': 'Venkatachalam', 'Affiliation': 'Center for Anesthesia and Research Excellence, Department of Anesthesia Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Valluvan', 'Initials': 'V', 'LastName': 'Rangasamy', 'Affiliation': 'Center for Anesthesia and Research Excellence, Department of Anesthesia Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Balachundhar', 'Initials': 'B', 'LastName': 'Subramaniam', 'Affiliation': 'Center for Anesthesia and Research Excellence, Department of Anesthesia Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA. Electronic address: bsubrama@bidmc.harvard.edu.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.07.058']
2656,32798174,"Effects of lavender oil intervention before endoscopic retrograde cholangiopancreatography on patients' vital signs, pain and anxiety: A randomized controlled study.","BACKGROUND


This study was carried out to determine the effects of lavender oil intervention before endoscopic retrograde cholangiopancreatography (ERCP) on patients' vital signs, pain and anxiety.
MATERIALS AND METHODS


This study was designed as a randomized controlled study. The population of the study consisted of adult patients who were going to receive ERCP at the gastroenterology clinic of a university hospital. Ninety patients participated in the study. The data were collected using a Patient Information Form, a Pre-Post Test Record Form, VAS and the State Anxiety Scale.
RESULTS


After lavender oil intervention, the pulse rate, systolic-diastolic blood pressure, pain and anxiety levels of the patients in the experiment group were reduced, their oxygen saturation levels were increased, and the difference between the groups was statistically significant (p < 0.05).
CONCLUSION


Lavender oil applied on the patients before the ERCP procedure reduced their pulse rate, systolic-diastolic blood pressure, pain and anxiety levels, while it increased their oxygen saturation levels.",2020,"After lavender oil intervention, the pulse rate, systolic-diastolic blood pressure, pain and anxiety levels of the patients in the experiment group were reduced, their oxygen saturation levels were increased, and the difference between the groups was statistically significant (p < 0.05).
","['Ninety patients participated in the study', 'adult patients who were going to receive ERCP at the gastroenterology clinic of a university hospital', ""patients' vital signs, pain and anxiety""]","['lavender oil intervention before endoscopic retrograde cholangiopancreatography (ERCP', 'lavender oil intervention', 'endoscopic retrograde cholangiopancreatography', 'Lavender oil']","['oxygen saturation levels', 'pulse rate, systolic-diastolic blood pressure, pain and anxiety levels']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C3834491', 'cui_str': 'Gastroenterology clinic'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0064694', 'cui_str': 'lavender oil'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}]","[{'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",90.0,0.0348491,"After lavender oil intervention, the pulse rate, systolic-diastolic blood pressure, pain and anxiety levels of the patients in the experiment group were reduced, their oxygen saturation levels were increased, and the difference between the groups was statistically significant (p < 0.05).
","[{'ForeName': 'Seyhan', 'Initials': 'S', 'LastName': 'Citlik Saritas', 'Affiliation': 'Medical Nursing Department, Faculty of Nursing, Inonu University, 44280 Malatya, Turkey. Electronic address: seyhancitlik@hotmail.com.'}, {'ForeName': 'Zeliha', 'Initials': 'Z', 'LastName': 'Buyukbayram', 'Affiliation': 'Medical Nursing Department, Siirt Health School, Siirt University, Siirt, Turkey.'}, {'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Kaplan Serin', 'Affiliation': 'Medical Nursing Department, Health School, Munzur University, Tunceli, Turkey.'}, {'ForeName': 'Yilmaz', 'Initials': 'Y', 'LastName': 'Bilgic', 'Affiliation': 'Gastroenterology Department, Medical School, Inonu University, Malatya, Turkey.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2020.07.011']
2657,32796016,Does the Spraino low-friction shoe patch prevent lateral ankle sprain injury in indoor sports? A pilot randomised controlled trial with 510 participants with previous ankle injuries.,"BACKGROUND


Lateral ankle sprains are common in indoor sports. High shoe-surface friction is considered a risk factor for non-contact lateral ankle sprains. Spraino is a novel low-friction patch that can be attached to the outside of sports shoes to minimise friction at the lateral edge, which could mitigate the risk of such injury. We aimed to determine preliminary effectiveness (incidence rate and severity) and safety (harms) of Spraino to prevent lateral ankle sprains among indoor sport athletes.
METHODS


In this exploratory, parallel-group, two-arm pilot randomised controlled trial, 510 subelite indoor sport athletes with a previous lateral ankle sprain were randomly allocated (1:1) to Spraino or 'do-as-usual'. Allocation was concealed and the trial was outcome assessor blinded. Match and training exposure, number of injuries and associated time loss were captured weekly via text messages. Information on harms, fear-of-injury and ankle pain was also documented.
RESULTS


480 participants completed the trial. They reported a total of 151 lateral ankle sprains, of which 96 were categorised as non-contact, and 50 as severe. All outcomes favoured Spraino with incidence rate ratios of 0.87 (95% CI 0.62 to 1.23) for all lateral ankle sprains; 0.64 (95% CI 0.42 to 0.98) for non-contact lateral ankle sprains; and 0.47 (95% CI 0.25 to 0.88) for severe lateral ankle sprains. Time loss per injury was also lower in the Spraino group (1.8 vs 2.8 weeks, p=0.014). Six participants reported minor harms because of Spraino.
CONCLUSION


Compared with usual care, athletes allocated to Spraino had a lower risk of lateral ankle sprains and less time loss, with only few reported minor harms.
TRIAL REGISTRATION NUMBER


NCT03311490.",2020,"Compared with usual care, athletes allocated to Spraino had a lower risk of lateral ankle sprains and less time loss, with only few reported minor harms.
","['480 participants completed the trial', '510 participants with previous ankle injuries', 'lateral ankle sprains among indoor sport athletes', '510 subelite indoor sport athletes with a previous lateral ankle sprain']","[""Spraino or 'do-as-usual"", 'Spraino']","['incidence rate ratios', 'Time loss per injury', 'risk of lateral ankle sprains and less time loss', 'harms, fear-of-injury and ankle pain', 'Match and training exposure, number of injuries and associated time loss', 'severe lateral ankle sprains']","[{'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517800', 'cui_str': '510'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0085111', 'cui_str': 'Injury of ankle'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]",[],"[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}, {'cui': 'C2874943', 'cui_str': 'Fear of injury'}, {'cui': 'C0238656', 'cui_str': 'Ankle pain'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",510.0,0.302455,"Compared with usual care, athletes allocated to Spraino had a lower risk of lateral ankle sprains and less time loss, with only few reported minor harms.
","[{'ForeName': 'Filip Gertz', 'Initials': 'FG', 'LastName': 'Lysdal', 'Affiliation': 'Department of Health Science and Technology, Sport Sciences, Aalborg University, Aalborg, Denmark fgly@hst.aau.dk.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bandholm', 'Affiliation': 'Department of Physical and Occupational Therapy, Physical Medicine and Rehabilitation Research-Copenhagen, Amager-Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Janne Schurmann', 'Initials': 'JS', 'LastName': 'Tolstrup', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark.'}, {'ForeName': 'Mikkel Bek', 'Initials': 'MB', 'LastName': 'Clausen', 'Affiliation': 'Department of Orthopedic Surgery, Sports Orthopedic Research Center-Copenhagen, Amager-Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Mann', 'Affiliation': 'Clinical Research Centre, Amager-Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Pelle Baggesgaard', 'Initials': 'PB', 'LastName': 'Petersen', 'Affiliation': 'Section for Surgical Pathophysiology 7621, Rigshospitalet, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Thor Buch', 'Initials': 'TB', 'LastName': 'Grønlykke', 'Affiliation': 'Spraino ApS, Copenhagen, Denmark.'}, {'ForeName': 'Uwe G', 'Initials': 'UG', 'LastName': 'Kersting', 'Affiliation': 'Department of Health Science and Technology, Sport Sciences, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Eamonn', 'Initials': 'E', 'LastName': 'Delahunt', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Thorborg', 'Affiliation': 'Department of Physical and Occupational Therapy, Physical Medicine and Rehabilitation Research-Copenhagen, Amager-Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}]",British journal of sports medicine,['10.1136/bjsports-2019-101767']
2658,32796054,Economic evaluation of computerised interpretation of fetal heart rate during labour: a cost-consequence analysis alongside the INFANT study.,"OBJECTIVE


Economic evaluation of computerised decision-support software intended to assist in the interpretation of a cardiotocography (CTG) during birth.
DESIGN


Individual patient level data from the INFANT study (an unmasked randomised controlled trial).
SETTING


Maternity units in the UK and Ireland.
POPULATION


Singleton or twin pregnancy women of 35 weeks' gestation or more and receiving continuous electronic fetal monitoring during labour.
INTERVENTION


Computerised decision-support software.
METHODS


Cost-consequence analysis presenting costs and outcomes with a time horizon of 2 years from a government healthcare perspective. Unit cost data collected from a combination of primary and secondary sources.
MAIN OUTCOME MEASURES


Primary clinical outcomes were (i) composite 'poor neonatal outcome' and (ii) developmental assessment at age 2 years in a subset of surviving children. Mean cost per mother and infant dyad from birth to hospital discharge, and from hospital discharge to 24 months follow-up. Maternal health-related quality of life was assessed at 12 and 24 months follow-up using the EuroQol three-level health-related quality of life instrument (EQ-5D-3L).
RESULTS


Data were analysed for 46 042 women and 46 614 infants. No statistically significant differences were detected between trial arms in any of the primary clinical outcomes or maternal quality of life. No statistically significant differences in costs were detected in maternal or infant costs from trial entry to hospital discharge or overall from hospital discharge to 2-year follow-up.
CONCLUSIONS


Decision-support software during labour is not associated with additional maternal or infant benefits and over a 2-year period the software did not lead to additional costs or savings to the National Health Service.
TRIAL REGISTRATION NUMBER


ISRCTN98680152.",2020,"No statistically significant differences in costs were detected in maternal or infant costs from trial entry to hospital discharge or overall from hospital discharge to 2-year follow-up.
","['Maternity units in the UK and Ireland', '2\u2009years from a government healthcare perspective', 'Data were analysed for 46\u2009042 women and 46\u2009614 infants', 'fetal heart rate during labour', ""Singleton or twin pregnancy women of 35 weeks' gestation or more and receiving continuous electronic fetal monitoring during labour""]",[],"['Mean cost per mother and infant dyad from birth to hospital discharge, and from hospital discharge', 'costs', 'maternal quality of life', 'Maternal health-related quality of life', ""i) composite 'poor neonatal outcome' and (ii) developmental assessment at age 2\u2009years in a subset of surviving children""]","[{'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0152150', 'cui_str': 'Twin pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0007208', 'cui_str': 'CTG, Antepartum'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",,0.222213,"No statistically significant differences in costs were detected in maternal or infant costs from trial entry to hospital discharge or overall from hospital discharge to 2-year follow-up.
","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Schroeder', 'Affiliation': 'Centre for the Health Economy, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Miaoqing', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'National Perinatal Epidemiology Unit (NPEU), Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brocklehurst', 'Affiliation': 'Birmingham Clinical Trials Unit, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Linsell', 'Affiliation': 'National Perinatal Epidemiology Unit (NPEU), Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Rivero-Arias', 'Affiliation': 'National Perinatal Epidemiology Unit (NPEU), Nuffield Department of Population Health, University of Oxford, Oxford, UK oliver.rivero@npeu.ox.ac.uk.'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2020-318806']
2659,32796084,Changes in medication administration error rates associated with the introduction of electronic medication systems in hospitals: a multisite controlled before and after study.,"BACKGROUND


Electronic medication systems (EMS) have been highly effective in reducing prescribing errors, but little research has investigated their effects on medication administration errors (MAEs).
OBJECTIVE


To assess changes in MAE rates and types associated with EMS implementation.
METHODS


This was a controlled before and after study (three intervention and three control wards) at two adult teaching hospitals. Intervention wards used an EMS with no bar-coding. Independent, trained observers shadowed nurses and recorded medications administered and compliance with 10 safety procedures. Observational data were compared against medication charts to identify errors (eg, wrong dose). Potential error severity was classified on a 5-point scale, with those scoring ≥3 identified as serious. Changes in MAE rates preintervention and postintervention by study group, accounting for differences at baseline, were calculated.
RESULTS


7451 administrations were observed (4176 pre-EMS and 3275 post-EMS). At baseline, 30.2% of administrations contained ≥1 MAE, with wrong intravenous rate, timing, volume and dose the most frequent. Post-EMS, MAEs decreased on intervention wards relative to control wards by 4.2 errors per 100 administrations (95% CI 0.2 to 8.3; p=0.04). Wrong timing errors alone decreased by 3.4 per 100 administrations (95% CI 0.01 to 6.7; p<0.05). EMS use was associated with an absolute decline in potentially serious MAEs by 2.4% (95% CI 0.8 to 3.9; p=0.003), a 56% reduction in the proportion of potentially serious MAEs. At baseline, 74.1% of administrations were non-compliant with ≥1 of 10 procedures and this rate did not significantly improve post-EMS.
CONCLUSIONS


Implementation of EMS was associated with a modest, but significant, reduction in overall MAE rate, but halved the proportion of MAEs rated as potentially serious.",2020,"Post-EMS, MAEs decreased on intervention wards relative to control wards by 4.2 errors per 100 administrations (95% CI 0.2 to 8.3; p=0.04).",['hospitals'],[],"['proportion of potentially serious MAEs', 'overall MAE rate']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],"[{'cui': 'C3469597', 'cui_str': 'Administration of medication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0286540', 'cui_str': 'MAV protocol'}]",7451.0,0.0392163,"Post-EMS, MAEs decreased on intervention wards relative to control wards by 4.2 errors per 100 administrations (95% CI 0.2 to 8.3; p=0.04).","[{'ForeName': 'Johanna I', 'Initials': 'JI', 'LastName': 'Westbrook', 'Affiliation': 'Centre for Health Systems and Safety Research, Macquarie University Australian Institute of Health Innovation, Sydney, New South Wales, Australia johanna.westbrook@mq.edu.au.'}, {'ForeName': 'Neroli S', 'Initials': 'NS', 'LastName': 'Sunderland', 'Affiliation': 'Centre for Health Systems and Safety Research, Macquarie University Australian Institute of Health Innovation, Sydney, New South Wales, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Woods', 'Affiliation': 'Centre for Health Systems and Safety Research, Macquarie University Australian Institute of Health Innovation, Sydney, New South Wales, Australia.'}, {'ForeName': 'Magda Z', 'Initials': 'MZ', 'LastName': 'Raban', 'Affiliation': 'Centre for Health Systems and Safety Research, Macquarie University Australian Institute of Health Innovation, Sydney, New South Wales, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gates', 'Affiliation': 'Centre for Health Systems and Safety Research, Macquarie University Australian Institute of Health Innovation, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Centre for Health Systems and Safety Research, Macquarie University Australian Institute of Health Innovation, Sydney, New South Wales, Australia.'}]",BMJ health & care informatics,['10.1136/bmjhci-2020-100170']
2660,32796255,Effects of Eight Weeks of 16: 8 Time-restricted Eating in Male Middle- and Long-Distance Runners.,"PURPOSE


Eight weeks of time-restricted eating (TRE) in concert with habitual exercise training was investigated for effects on body composition, energy and macronutrient intakes, indices of endurance running performance, and markers of metabolic health in endurance athletes.
METHODS


Male middle and long distance runners (n=23) were randomly assigned to TRE (n=12), or habitual dietary intake (CON; n=11). TRE required participants to consume all of their dietary intake within an 8 h eating window (so-called ""16:8"" TRE), but dietary patterns, food choices, and energy intake were ad libitum during this window. Participants continued their habitual training during the intervention period. Participants completed an incremental exercise test before (PRE) and after (POST) the 8 week intervention for assessment of blood lactate concentrations, running economy and maximal oxygen uptake. Fasted blood samples were analysed for glucose, insulin and triglyceride concentrations. Dietary intake was assessed at PRE, MID (week 4), and POST using a four-day semi-weighed food diary.
RESULTS


Seventeen participants (TRE, n=10; CON, n=7) completed the intervention. Training load did not differ between groups for the duration of the intervention period. TRE resulted in a reduction in body mass (mean difference of -1.92 (95% CI, -3.52 to -0.32) kg, P=0.022). Self-reported daily energy intake was lower in TRE at MID and POST (group*time interaction, P=0.049). No effect of TRE was observed for oxygen consumption, respiratory exchange ratio, running economy, blood lactate concentrations or heart rate during exercise, nor were any effects on glucose, insulin or triglyceride concentrations observed.
CONCLUSION


Eight weeks of 16:8 TRE in middle and long distance runners resulted in a decrease in body mass commensurate with a reduction in daily energy intake, but did not alter indices of endurance running performance or metabolic health.",2020,"No effect of TRE was observed for oxygen consumption, respiratory exchange ratio, running economy, blood lactate concentrations or heart rate during exercise, nor were any effects on glucose, insulin or triglyceride concentrations observed.
","['endurance athletes', 'Seventeen participants (TRE, n=10; CON, n=7) completed the intervention', '16: 8 Time-restricted Eating in Male Middle- and Long-Distance Runners', 'Male middle and long distance runners (n=23']","['time-restricted eating (TRE', 'habitual exercise training', 'TRE', 'incremental exercise test before (PRE', 'habitual dietary intake', 'habitual training']","['body mass', 'glucose, insulin or triglyceride concentrations observed', 'glucose, insulin and triglyceride concentrations', 'endurance running performance or metabolic health', 'oxygen consumption, respiratory exchange ratio, running economy, blood lactate concentrations or heart rate', 'Dietary intake', 'body composition, energy and macronutrient intakes, indices of endurance running performance, and markers of metabolic health', 'blood lactate concentrations, running economy and maximal oxygen uptake', 'Self-reported daily energy intake']","[{'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",,0.100897,"No effect of TRE was observed for oxygen consumption, respiratory exchange ratio, running economy, blood lactate concentrations or heart rate during exercise, nor were any effects on glucose, insulin or triglyceride concentrations observed.
","[{'ForeName': 'Aidan J', 'Initials': 'AJ', 'LastName': 'Brady', 'Affiliation': 'School of Health and Human Performance, Dublin City University, Dublin, Ireland.'}, {'ForeName': 'Henry M', 'Initials': 'HM', 'LastName': 'Langton', 'Affiliation': 'School of Health and Human Performance, Dublin City University, Dublin, Ireland.'}, {'ForeName': 'Mollie', 'Initials': 'M', 'LastName': 'Mulligan', 'Affiliation': 'School of Health and Human Performance, Dublin City University, Dublin, Ireland.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Egan', 'Affiliation': 'School of Health and Human Performance, Dublin City University, Dublin, Ireland.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002488']
2661,32796259,Comparison of Supervised and Telehealth Delivery of Worksite Exercise for Prevention of Low Back Pain in Firefighters: A Cluster Randomized Trial.,"OBJECTIVE


This study assessed worksite exercise delivered by on-site supervision (supervised) or telehealth to reduce lost work time (LWT) related to low back pain (LBP) in firefighters.
METHODS


A cluster randomized controlled trial assigned 264 career firefighters to supervised (n = 86) or telehealth (n = 95) back and core exercises 2X/week for 12 months, or control (n = 83).
RESULTS


58.0% (153/264) of participants reported LBP and 7.6% (20/264) reported LWT related to LBP (control n = 10, supervised n = 5, telehealth n = 5). Participants in the control group experienced 1.15 times as many hours of LWT as the supervised group, and 5.51 times as many hours of LWT as the telehealth group.
CONCLUSIONS


Worksite exercise, delivered by on-site supervision or telehealth, can reduce LWT related to LBP in career firefighters.",2020,"RESULTS


58.0% (153/264) of participants reported LBP and 7.6% (20/264) reported LWT related to LBP (control n = 10, supervised n = ",['Low Back Pain in Firefighters'],"['Supervised and Telehealth Delivery of Worksite Exercise', '264 career firefighters to supervised (n\u200a=\u200a86) or telehealth (n\u200a=\u200a95) back and core exercises 2X/week for 12 months, or control', 'worksite exercise delivered by on-site supervision (supervised) or telehealth to reduce lost work time (LWT', 'Worksite exercise']",[],"[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",[],264.0,0.0476192,"RESULTS


58.0% (153/264) of participants reported LBP and 7.6% (20/264) reported LWT related to LBP (control n = 10, supervised n = ","[{'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Mayer', 'Affiliation': 'US Spine & Sport Foundation, San Diego, CA (Mayer, Lane, Johnson), Tampa, FL (Brady), University of South Florida, Tampa, FL (Chen, Lu), Spine Research LLC, Winchester, MA (Dagenais).'}, {'ForeName': 'Charity L', 'Initials': 'CL', 'LastName': 'Lane', 'Affiliation': ''}, {'ForeName': ""O'Dane"", 'Initials': 'O', 'LastName': 'Brady', 'Affiliation': ''}, {'ForeName': 'Henian', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Brittany V B', 'Initials': 'BVB', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Dagenais', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001993']
2662,32796287,"The effect of Fennel seed powder on estradiol levels, menopausal symptoms, and sexual desire in postmenopausal women.","OBJECTIVES


The present study was designed to determine the effect of Fennel seed powder on menopausal symptoms, sexual desire, and serum estradiol levels in postmenopausal women.
METHODS


The present study was conducted on 80 eligible women (45-60 y) who were referred to the Mofatteh Gynecology Clinic in Yasuj, Iran. Participants were randomized into equal intervention and control (control) groups. The intervention and control groups received four capsules of Fennel seed powder (2 gr) and starch-containing capsules (2 gr) daily over 8 weeks, respectively. Menopausal symptoms and sexual desire of the participants were evaluated using both the menopausal Kupperman index and Hurlbert index of sexual desire. The questionnaires were completed at baseline, week 4 and week 8 of the study by the participants. The serum estradiol levels were measured at baseline and also at the end of the study. The Chi-square test, independent t test, and repeated-measures analysis of variance were used to analyze the data.
RESULTS


Menopausal symptoms score significantly decreased from 30.8 ± 6 to 19 ± 5.5 in the intervention group and also from 31.2 ± 6.5 to 26.4 ± 6.2 in the control group (P < 0.05). Treatment with Fennel seed did not significantly enhance the participants sexual desire (P > 0.05). The estradiol levels declined in the intervention (from 60.4 ± 43.4 to 52.6 ± 25.7) and control groups (from 55.1 ± 22.4 to 39.9 ± 26.9). However, this decrease was lower in the intervention group than in the control group. The intergroup differences were not statistically significant (P > 0.05).
CONCLUSIONS


The results of the present study indicated that daily use of Fennel seed significantly improved menopausal symptoms in postmenopausal women over 8 weeks, though its effect on estradiol levels and sexual desire was not significant. Further studies with a larger sample size and longer duration are needed to verify these findings.",2020,"RESULTS


Menopausal symptoms score significantly decreased from 30.8 ± 6 to 19 ± 5.5 in the intervention group and also from 31.2 ± 6.5 to 26.4 ± 6.2 in the control group (P < 0.05).","['postmenopausal women', '80 eligible women (45-60 y) who were referred to the Mofatteh Gynecology Clinic in Yasuj, Iran']","['four capsules of Fennel seed powder (2 gr) and starch-containing capsules', 'Fennel seed powder']","['Menopausal symptoms score', 'estradiol levels', 'estradiol levels, menopausal symptoms, and sexual desire', 'Menopausal symptoms and sexual desire', 'menopausal Kupperman index and Hurlbert index of sexual desire', 'serum estradiol levels', 'participants sexual desire', 'menopausal symptoms, sexual desire, and serum estradiol levels', 'menopausal symptoms', 'estradiol levels and sexual desire']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C3839674', 'cui_str': 'Gynecology clinic'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0453256', 'cui_str': 'Fennel seed preparation'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}]",80.0,0.0505872,"RESULTS


Menopausal symptoms score significantly decreased from 30.8 ± 6 to 19 ± 5.5 in the intervention group and also from 31.2 ± 6.5 to 26.4 ± 6.2 in the control group (P < 0.05).","[{'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Ghaffari', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Social Determinants of Health Research Center, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Hosseininik', 'Affiliation': 'School of Nursing, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Ardashir', 'Initials': 'A', 'LastName': 'Afrasiabifar', 'Affiliation': 'Professor of Nursing, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Sadeghi', 'Affiliation': 'Medicinal Plants Research Center, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Hosseininik', 'Affiliation': 'Petroleum Industry Health Organization, Hospital Gachsaran Oil Industry (Besat), Ministry of Petroleum, Tehran, Iran.'}, {'ForeName': 'Seyedeh Marzieh', 'Initials': 'SM', 'LastName': 'Tabatabaei', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Nazafarin', 'Initials': 'N', 'LastName': 'Hosseini', 'Affiliation': 'Medicinal Plants Research Center, Yasuj University of Medical Sciences, Yasuj, Iran.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001604']
2663,32796301,Conical Biosilicate Implant for Volume Augmentation in Anophthalmic Sockets.,"The ideal implant for anophthalmic socket reconstruction has yet to be developed. Biosilicate, a highly bioactive glass-ceramic, has been used in the composition of conical implants, which were initially tested in rabbit orbits with excellent results. However, the use of this material and the conical shape of the implants require further study in the human anophthalmic socket. Thus, we propose the use of a new conical implant composed of Biosilicate for orbital volume augmentation in anophthalmic sockets. This prospective, randomized study included 45 patients receiving conical implants composed of either Biosilicate or polymethylmethacrylate (control). Patients were evaluated clinically before and 7, 30, 60, 120, and 180 days after implantation. Systemic evaluations, laboratory tests, and computed tomography of the orbits were performed preoperatively and 180 days postoperatively. Both groups had good outcomes with no significant infectious or inflammatory processes. Only 1 patient, in the Biosilicate group, had early implant extrusion. Laboratory tests were normal in both groups. Computed tomography scans showed that the implants in both groups were well positioned. The new conical implant composed of Biosilicate was successfully used for anophthalmic socket reconstruction. This implant may provide a good alternative to the only conical implant currently available on the market, which is composed of porous polyethylene.",2020,Both groups had good outcomes with no significant infectious or inflammatory processes.,"['Anophthalmic Sockets', '45 patients receiving conical implants composed of either Biosilicate or polymethylmethacrylate (control']",['Conical Biosilicate Implant'],"['Systemic evaluations, laboratory tests, and computed tomography of the orbits']","[{'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C3179298', 'cui_str': 'Biosilicate'}, {'cui': 'C0005533', 'cui_str': 'Polymethyl methacrylate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3179298', 'cui_str': 'Biosilicate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0029180', 'cui_str': 'Orbital cavity'}]",45.0,0.0209182,Both groups had good outcomes with no significant infectious or inflammatory processes.,"[{'ForeName': 'Simone Milani', 'Initials': 'SM', 'LastName': 'Brandão', 'Affiliation': 'Division of Medicine, Federal University of Sao Carlos (UFCar), Sao Carlos, São Paulo, Brazil.'}, {'ForeName': 'Rodolfo Artioli', 'Initials': 'RA', 'LastName': 'Schellini', 'Affiliation': 'Radiology Department of Medical School, State University of Sao Paulo (UNESP), Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Peitl', 'Affiliation': 'Materials Engineering Department, Center for Research, Technology and Education in Vitreous Materials (CeRTEV), Federal University of São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Edgar Dutra', 'Initials': 'ED', 'LastName': 'Zanotto', 'Affiliation': 'Materials Engineering Department, Center for Research, Technology and Education in Vitreous Materials (CeRTEV), Federal University of São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Matayoshi', 'Affiliation': 'Ophthalmology Department of Medical School, University of São Paulo (USP), São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Roberta Lilian Fernandes de Sousa', 'Initials': 'RLFS', 'LastName': 'Meneghim', 'Affiliation': 'Ophthalmology Department of Medical School, State University of Sao Paulo (UNESP), Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Silvana Artioli', 'Initials': 'SA', 'LastName': 'Schellini', 'Affiliation': 'Ophthalmology Department of Medical School, State University of Sao Paulo (UNESP), Botucatu, São Paulo, Brazil.'}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000006692']
2664,32798048,Reply to Letter to the Editor: 'Comparison of virtual reality rehabilitation and conventional rehabilitation in Parkinson's disease: a randomised controlled trial'.,,2020,,"[""Parkinson's disease""]",['virtual reality rehabilitation and conventional rehabilitation'],[],"[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]",[],,0.0697807,,"[{'ForeName': 'Costanza', 'Initials': 'C', 'LastName': 'Pazzaglia', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Imbimbo', 'Affiliation': 'Department of Neurorehabilitation, IRCCS Don Carlo Gnocchi, Milan, Italy.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Tranchita', 'Affiliation': 'Department of Movement, Human and Health Sciences, Division of Health Sciences, University of Rome Foro Italico, Rome, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Minganti', 'Affiliation': 'Department of Movement, Human and Health Sciences, Division of Health Sciences, University of Rome Foro Italico, Rome, Italy.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Ricciardi', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Rita Lo', 'Initials': 'RL', 'LastName': 'Monaco', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Attilio', 'Initials': 'A', 'LastName': 'Parisi', 'Affiliation': 'Department of Movement, Human and Health Sciences, Division of Health Sciences, University of Rome Foro Italico, Rome, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Padua', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Department of Geriatrics, Neurosciences and Orthopaedics, Università Cattolica del Sacro Cuore, Rome, Italy. Electronic address: luca.padua@unicatt.it.'}]",Physiotherapy,['10.1016/j.physio.2020.07.001']
2665,32798050,Impact of different front-of-pack nutrition labels on online food choices.,"Front-of-pack nutrition labels (FOP-NL) are efficient tools for increasing consumers' awareness of the nutritional quality of food products, prompting healthier food choices. The main goal of this study was to evaluate the impact of four FOP-NL schemes - Traffic Light label (TL), Guideline Daily Amounts (%GDA), Nutri-Score (NS) and Health Star Rating (HSR) - on consumers' selection of food products according to perceived nutritional quality. A cross-sectional open-label crossover randomized controlled study was carried out among Portuguese consumers. A web-based questionnaire was used to assess participants' a) preferences regarding FOP-NLs and b) capacity to select healthy products in a food selection task using the information from FOP-NL schemes. When performing the selection task, participants had the option to indicate that they could not decide simply based on the presented FOP-NL (requiring more information). Overall, 357 adults participated in the study. Regarding consumers' preferences, TL received the most favorable responses, while NS received the fewest. All FOP-NLs performed better than the no-nutritional label control condition in the food selection task. The highest proportion of correct choices was obtained for TL (72.3%), followed by HSR (70.9%), %GDA (70.0%) and NS (62.2%), though no significant differences were found among FOP-NLs. Percentages of respondents indicating not being able to answer due to lack of information affected the proportion of correct choices, with 10.3% for TL, 12.9% for %GDA, 14.6% for HSR, and 25.8% for NS, indicating they were unable to choose without additional information. Although no particular FOP-NL system stood out as the most significantly effective, TL was the most preferred by Portuguese adults. Long-term real-world evidence is necessary to assess the impact of FOP-NL systems on individuals' food choices.",2020,"The highest proportion of correct choices was obtained for TL (72.3%), followed by HSR (70.9%), %GDA (70.0%) and NS (62.2%), though no significant differences were found among FOP-NLs.","['357 adults participated in the study', 'Portuguese consumers']","['Front-of-pack nutrition labels (FOP-NL', 'FOP-NL schemes - Traffic Light label (TL), Guideline Daily Amounts (%GDA', 'different front-of-pack nutrition labels']","['highest proportion of correct choices', 'Nutri-Score (NS) and Health Star Rating (HSR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032730', 'cui_str': 'Portuguese'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0028711', 'cui_str': 'Nutrition Labeling'}, {'cui': 'C0016037', 'cui_str': 'Progressive myositis ossificans'}, {'cui': 'C0442664', 'cui_str': 'Traffic light'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0523683', 'cui_str': 'Guanine deaminase measurement'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0018757', 'cui_str': 'Research, Health Services'}]",357.0,0.0356447,"The highest proportion of correct choices was obtained for TL (72.3%), followed by HSR (70.9%), %GDA (70.0%) and NS (62.2%), though no significant differences were found among FOP-NLs.","[{'ForeName': 'Osvaldo', 'Initials': 'O', 'LastName': 'Santos', 'Affiliation': 'Instituto de Saúde Ambiental, Faculdade de Medicina, Universidade de Lisboa. Avenida Professor Egas Moniz, 1649-028, Lisboa, Portugal; Unbreakable Idea Research, Lda, Painho, Portugal. Electronic address: osantos@medicina.ulisboa.pt.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Alarcão', 'Affiliation': 'Instituto de Saúde Ambiental, Faculdade de Medicina, Universidade de Lisboa. Avenida Professor Egas Moniz, 1649-028, Lisboa, Portugal; Centro de Investigação e Estudos de Sociologia (CIES-IUL), Instituto Universitário de Lisboa (ISCTE-IUL), Lisboa, Portugal. Electronic address: valarcao@medicina.ulisboa.pt.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Feteira-Santos', 'Affiliation': 'Instituto de Saúde Ambiental, Faculdade de Medicina, Universidade de Lisboa. Avenida Professor Egas Moniz, 1649-028, Lisboa, Portugal. Electronic address: rodrigosantos@medicina.ulisboa.pt.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Fernandes', 'Affiliation': 'Instituto de Saúde Ambiental, Faculdade de Medicina, Universidade de Lisboa. Avenida Professor Egas Moniz, 1649-028, Lisboa, Portugal. Electronic address: joao@campus.ul.pt.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Virgolino', 'Affiliation': 'Instituto de Saúde Ambiental, Faculdade de Medicina, Universidade de Lisboa. Avenida Professor Egas Moniz, 1649-028, Lisboa, Portugal. Electronic address: avirgolino@medicina.ulisboa.pt.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Sena', 'Affiliation': 'Direção-Geral da Saúde, Lisboa, Portugal. Alameda D, Afonso Henriques, 45, 1049-005, Lisboa, Portugal.'}, {'ForeName': 'Carlota Pacheco', 'Initials': 'CP', 'LastName': 'Vieira', 'Affiliation': 'Direção-Geral da Saúde, Lisboa, Portugal. Alameda D, Afonso Henriques, 45, 1049-005, Lisboa, Portugal.'}, {'ForeName': 'Maria João', 'Initials': 'MJ', 'LastName': 'Gregório', 'Affiliation': 'Programa Nacional para a Promoção da Alimentação Saudável, Direção-Geral da Saúde, Lisboa, Portugal, Alameda D, Afonso Henriques, 45, 1049-005, Lisboa, Portugal; Faculdade de Ciências da Nutrição e Alimentação da Universidade do Porto. Rua do Campo Alegre, 823, 4150-180, Porto, Portugal. Electronic address: mariajoaobg@dgs.min-saude.pt.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Nogueira', 'Affiliation': 'Instituto de Saúde Ambiental, Faculdade de Medicina, Universidade de Lisboa. Avenida Professor Egas Moniz, 1649-028, Lisboa, Portugal; Direção-Geral da Saúde, Lisboa, Portugal. Alameda D, Afonso Henriques, 45, 1049-005, Lisboa, Portugal; Laboratório de Biomatemática, Faculdade de Medicina, Universidade de Lisboa. Avenida Professor Egas Moniz, 1649-028, Lisboa, Portugal. Electronic address: pnogueira@medicina.ulisboa.pt.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Graça', 'Affiliation': 'Programa Nacional para a Promoção da Alimentação Saudável, Direção-Geral da Saúde, Lisboa, Portugal, Alameda D, Afonso Henriques, 45, 1049-005, Lisboa, Portugal; Faculdade de Ciências da Nutrição e Alimentação da Universidade do Porto. Rua do Campo Alegre, 823, 4150-180, Porto, Portugal. Electronic address: pedrograca@fcna.up.pt.'}, {'ForeName': 'Andreia', 'Initials': 'A', 'LastName': 'Costa', 'Affiliation': 'Instituto de Saúde Ambiental, Faculdade de Medicina, Universidade de Lisboa. Avenida Professor Egas Moniz, 1649-028, Lisboa, Portugal; Direção-Geral da Saúde, Lisboa, Portugal. Alameda D, Afonso Henriques, 45, 1049-005, Lisboa, Portugal; Escola Superior de Enfermagem de Lisboa, Lisboa, Portugal, Avenida Professor Egas Moniz, 1649-028, Lisboa, Portugal. Electronic address: andreiajsilvadacosta@gmail.com.'}]",Appetite,['10.1016/j.appet.2020.104795']
2666,32798059,"Impact of SLCO4C1 Genotypes, Creatinine, and Spironolactone on Digoxin Population Pharmacokinetic Variables in Patients With Cardiac Insufficiency.","PURPOSE


This study aimed to utilize a population pharmacokinetic method to obtain information about the influence of covariates on the in vivo behavior of digoxin in patients with cardiac insufficiency.
METHODS


A total of 228 therapeutic drug monitoring concentrations were retrospectively collected from 176 inpatients. The patients were randomly divided into a modeling group (n = 126) and a validation group (n = 50). The first-order absorption one-compartment model was used to develop a population pharmacokinetic model from a nonlinear mixed effects modeling approach. Sixteen single nucleotide polymorphisms involved in the pharmacokinetic variables of digoxin were identified by using the MassARRAY system. Various demographic parameters, biochemical test values, concomitant medications, and genetic variants were investigated.
FINDINGS


The typical population value of digoxin CL/F was 5.06 L/h, and the volume of distribution was 211.82 L. The drug CL/F was significantly related to serum creatinine, in a combination of spironolactone and SLCO4C1 genotypes of 2 variants (rs3114660 and rs3114661). Results of model evaluation and internal/external validation indicated a stable and precise performance of the final model.
IMPLICATIONS


For the first time, 2 single nucleotide polymorphisms (rs3114660 and rs3114661) in SLCO4C1 were found to significantly affect the elimination of digoxin in vivo. The final population model may be useful for the individualized dosing of digoxin for patients with cardiac insufficiency.",2020,"The drug CL/F was significantly related to serum creatinine, in a combination of spironolactone and SLCO4C1 genotypes of 2 variants (rs3114660 and rs3114661).","['A total of 228 therapeutic drug monitoring concentrations were retrospectively collected from 176 inpatients', 'patients with cardiac insufficiency', 'Patients With Cardiac Insufficiency']","['digoxin', 'SLCO4C1 Genotypes, Creatinine, and Spironolactone']",['pharmacokinetic variables of digoxin'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1720825', 'cui_str': 'Therapeutic Drug Monitoring'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}]",,0.0185196,"The drug CL/F was significantly related to serum creatinine, in a combination of spironolactone and SLCO4C1 genotypes of 2 variants (rs3114660 and rs3114661).","[{'ForeName': 'Pengqiang', 'Initials': 'P', 'LastName': 'Du', 'Affiliation': ""Department of Pharmacy, Fuwai Central China Cardiovascular Hospital, Central China Fuwai Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou, Henan, China.""}, {'ForeName': 'Aifeng', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': ""Department of Pharmacy, Fuwai Central China Cardiovascular Hospital, Central China Fuwai Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou, Henan, China.""}, {'ForeName': 'Yongcheng', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""Department of Pharmacy, Fuwai Central China Cardiovascular Hospital, Central China Fuwai Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou, Henan, China.""}, {'ForeName': 'Ao', 'Initials': 'A', 'LastName': 'Jia', 'Affiliation': ""Department of Pharmacy, Fuwai Central China Cardiovascular Hospital, Central China Fuwai Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou, Henan, China.""}, {'ForeName': 'Yafei', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Pharmacy, Fuwai Central China Cardiovascular Hospital, Central China Fuwai Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou, Henan, China.""}, {'ForeName': 'Xingang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing, China. Electronic address: lxg198320022003@163.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.07.011']
2667,32798079,Impact of mindfulness-based cognitive therapy on counseling self-efficacy: A randomized controlled crossover trial.,"OBJECTIVE


To investigate the impact of a structured eight-week mindfulness-based cognitive therapy (MBCT) program on counseling self-efficacy among counseling trainees.
METHODS


Undergraduate counseling trainees were randomized to an MBCT group (n = 25) or a waitlist control group (n = 25) with a crossover trial design. Psychological measurements regarding mindfulness, empathy, self-compassion, psychological distress, counseling self-efficacy as well as neuro-physiological measures including frontal midline theta activity, respiration rate, and skin conductance were taken at baseline (T1), after intervention (T2), and six-month follow-up (T3).
RESULTS


Mindfulness training could make significant positive changes in empathy, self-compassion, stress reduction, and counseling self-efficacy with this being backed up by both psychological and neuro-physiological evidence at T2. However, such differences between the two groups had greatly subsided after crossover in which carry-over effect and marked improvement were noted in the study and control group, respectively, at T3. In addition, mindfulness was the most significant determinant that contributed to counseling self-efficacy, followed by psychological distress reduction and self-compassion according to the regression models.
CONCLUSION


Integrating mindfulness into counseling training is beneficial for helping profession trainees.
PRACTICE IMPLICATION


Incorporating mindfulness into counseling training can enhance the necessary ""being mode"" qualities in counseling and address self-care issues during training.",2020,"RESULTS


Mindfulness training could make significant positive changes in empathy, self-compassion, stress reduction, and counseling self-efficacy with this being backed up by both psychological and neuro-physiological evidence at T2.","['counseling trainees', 'Undergraduate counseling trainees']","['MBCT', 'mindfulness-based cognitive therapy', 'structured eight-week mindfulness-based cognitive therapy (MBCT) program', 'counseling training', 'waitlist control group']","['psychological distress reduction and self-compassion', 'Psychological measurements regarding mindfulness, empathy, self-compassion, psychological distress, counseling self-efficacy as well as neuro-physiological measures including frontal midline theta activity, respiration rate, and skin conductance', 'empathy, self-compassion, stress reduction, and counseling self-efficacy', 'counseling self-efficacy']","[{'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}]",25.0,0.0113575,"RESULTS


Mindfulness training could make significant positive changes in empathy, self-compassion, stress reduction, and counseling self-efficacy with this being backed up by both psychological and neuro-physiological evidence at T2.","[{'ForeName': 'Sunny H W', 'Initials': 'SHW', 'LastName': 'Chan', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong. Electronic address: sunny.hw.chan@polyu.edu.hk.'}, {'ForeName': 'Calvin Kai-Ching', 'Initials': 'CK', 'LastName': 'Yu', 'Affiliation': 'Department of Counselling and Psychology, Hong Kong Shue Yan University, Hong Kong.'}, {'ForeName': 'Alex W O', 'Initials': 'AWO', 'LastName': 'Li', 'Affiliation': 'Department of Counselling and Psychology, Hong Kong Shue Yan University, Hong Kong.'}]",Patient education and counseling,['10.1016/j.pec.2020.07.022']
2668,32798096,Coping With Stress Through Texting: An Experimental Study.,"PURPOSE


Texting is used by many adolescents and has the potential to improve well-being, as youth can reach out for support immediately after experiencing a stressful situation. Many studies have examined whether texting is associated with well-being, but few have used experimental designs, preventing causal claims.
METHODS


In this experimental study, 130 adolescents (M age  = 12.41) participated with a same-gender friend whom they texted regularly. Both adolescents completed a task that elicited stress and then engaged in one of the following randomly assigned activities: texting their friend, watching a video on a cellphone (passive-phone condition), or sitting quietly (no activity condition). Participants reported their mood and stress levels after the stress task and again after the activity. Heart rate variability was measured throughout.
RESULTS


Participants who texted their friend reported higher moods (b = -.80, standard error [SE] = .24, p < .001, η p 2  = .09) and lower stress at the end of the study than those in the no activity condition (b = .51, SE = .25, p = .046, η p 2  = .04) and higher moods than adolescents in the passive-phone condition (b = -.74, SE = .25, p = .004, η p 2  = .08). No differences were noted between the passive-phone and no activity conditions. There were no differences in heart rate variability between the three conditions. The effects of texting on mood, self-reported stress, and heart rate variability did not differ by gender.
CONCLUSIONS


Both boys and girls may benefit from texting a friend after experiencing a stressful event.",2020,"RESULTS


Participants who texted their friend reported higher moods (b = -.80, standard error [SE] = .24,",['130 adolescents (M age \xa0= 12.41) participated with a same-gender friend whom they texted regularly'],"['activities: texting their friend, watching a video on a cellphone (passive-phone condition), or sitting quietly (no activity condition']","['mood and stress levels', 'mood, self-reported stress, and heart rate variability', 'heart rate variability', 'passive-phone and no activity conditions', 'Heart rate variability']","[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0079382', 'cui_str': 'Friend'}]","[{'cui': 'C2004436', 'cui_str': 'Activity therapy'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",130.0,0.0257641,"RESULTS


Participants who texted their friend reported higher moods (b = -.80, standard error [SE] = .24,","[{'ForeName': 'Joanna C', 'Initials': 'JC', 'LastName': 'Yau', 'Affiliation': 'School of Education, University of California, Irvine, California. Electronic address: joannay@usc.edu.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Reich', 'Affiliation': 'School of Education, University of California, Irvine, California.'}, {'ForeName': 'Tao-Yi', 'Initials': 'TY', 'LastName': 'Lee', 'Affiliation': 'Donald Bren School of Information and Computer Sciences, University of California, Irvine, California.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2020.07.004']
2669,30520944,Pretest probability for patients with suspected obstructive coronary artery disease: re-evaluating Diamond-Forrester for the contemporary era and clinical implications: insights from the PROMISE trial.,"AIMS


To update pretest probabilities (PTP) for obstructive coronary artery disease (CAD ≥ 50%) across age, sex, and clinical symptom strata, using coronary computed tomography angiography (CTA) in a large contemporary population of patients with stable chest pain referred to non-invasive testing.
METHODS AND RESULTS


We included patients enrolled in the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial and randomized to CTA. Exclusively level III-certified readers, blinded to demographic and clinical data, assessed the prevalence of CAD ≥ 50% in a central core lab. After comparing the recent European Society of Cardiology-Diamond and Forrester PTP (ESC-DF) with the actual observed prevalence of CAD ≥ 50%, we created a new PTP set by replacing the ESC-DF PTP with the observed prevalence of CAD ≥ 50% across strata of age, sex, and type of angina. In 4415 patients (48.3% men; 60.5 ± 8.2 years; 78% atypical angina; 11% typical angina; 11% non-anginal chest pain), the observed prevalence of CAD ≥ 50% was 13.9%, only one-third of the average ESC-DF PTP (40.6; P < 0.001 for difference). The PTP in the new set ranged 2-48% and were consistently lower than the ESC-DF PTP across all age, sex, and angina type categories. Initially, 4284/4415 (97%) patients were classified as intermediate-probability by the ESC-DF (PTP 15-85%); using the PROMISE-PTP, 50.2% of these patients were reclassified to the low PTP category (PTP < 15%).
CONCLUSION


The ESC-DF PTP overestimate vastly the actual prevalence of CAD ≥ 50%. A new set of PTP, derived from results of non-invasive testing, may substantially reduce the need for non-invasive tests in stable chest pain.",2019,"The PTP in the new set ranged 2-48% and were consistently lower than the ESC-DF PTP across all age, sex, and angina type categories.","['patients with suspected obstructive coronary artery disease', 'patients with stable chest pain referred to non-invasive testing']",['coronary computed tomography angiography (CTA'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}]","[{'cui': 'C1536105', 'cui_str': 'Angiography, CT'}]",[],4415.0,0.0455688,"The PTP in the new set ranged 2-48% and were consistently lower than the ESC-DF PTP across all age, sex, and angina type categories.","[{'ForeName': 'Borek', 'Initials': 'B', 'LastName': 'Foldyna', 'Affiliation': 'Cardiac MR PET CT Program, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, 165 Cambridge Street, Suite 400, Boston, MA, USA.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Udelson', 'Affiliation': 'Tufts University School of Medicine and the Cardiovascular Center, Tufts Medical Center, 800 Washington Street North, Boston, MA, USA.'}, {'ForeName': 'Júlia', 'Initials': 'J', 'LastName': 'Karády', 'Affiliation': 'Cardiac MR PET CT Program, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, 165 Cambridge Street, Suite 400, Boston, MA, USA.'}, {'ForeName': 'Dahlia', 'Initials': 'D', 'LastName': 'Banerji', 'Affiliation': 'Cardiac MR PET CT Program, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, 165 Cambridge Street, Suite 400, Boston, MA, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Lu', 'Affiliation': 'Cardiac MR PET CT Program, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, 165 Cambridge Street, Suite 400, Boston, MA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mayrhofer', 'Affiliation': 'Cardiac MR PET CT Program, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, 165 Cambridge Street, Suite 400, Boston, MA, USA.'}, {'ForeName': 'Daniel O', 'Initials': 'DO', 'LastName': 'Bittner', 'Affiliation': 'Cardiac MR PET CT Program, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, 165 Cambridge Street, Suite 400, Boston, MA, USA.'}, {'ForeName': 'Nandini M', 'Initials': 'NM', 'LastName': 'Meyersohn', 'Affiliation': 'Cardiac MR PET CT Program, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, 165 Cambridge Street, Suite 400, Boston, MA, USA.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Emami', 'Affiliation': 'Cardiac MR PET CT Program, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, 165 Cambridge Street, Suite 400, Boston, MA, USA.'}, {'ForeName': 'Tessa S S', 'Initials': 'TSS', 'LastName': 'Genders', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, 2400 Pratt Street, Durham, NC, USA.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Fordyce', 'Affiliation': 'Division of Cardiology, University of British Columbia, 2775 Laurel Street, Vancouver, BC, Canada.'}, {'ForeName': 'Maros', 'Initials': 'M', 'LastName': 'Ferencik', 'Affiliation': 'Cardiac MR PET CT Program, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, 165 Cambridge Street, Suite 400, Boston, MA, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, 2400 Pratt Street, Durham, NC, USA.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Cardiac MR PET CT Program, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, 165 Cambridge Street, Suite 400, Boston, MA, USA.'}]",European heart journal cardiovascular Imaging,['10.1093/ehjci/jey182']
2670,29564732,Validation of the oxygen desaturation index in the diagnostic workup of obstructive sleep apnea.,"INTRODUCTION


Obstructive sleep apnea (OSA) is common, and diagnosis requires expensive and laborious testing to assess the apnea hypopnea index (AHI). We performed an analysis to explore the relationship between the oxygen desaturation index (ODI) as measured with pulse oximetry and the AHI in our large portable monitoring (PM) database to find an optimal cutoff value for the ODI in order to be able to exclude AHI ≥ 5 on PM.
METHODS


Three thousand four hundred thirteen PM recordings were randomly divided into a training set (N = 2281) and a test set (N = 1132). The optimal cutoff for the ODI to exclude an AHI ≥ 5 on PM was determined in the training set and subsequently validated in the test set.
RESULTS


Area under the curve of the ODI to exclude an AHI ≥ 5 on PM was 0.997 in the training set and 0.996 in the test set. In the training set, the optimal cutoff to predict an AHI < 5 was an ODI < 5. Using this cutoff in the test set provided a sensitivity of 97.7%, a specificity of 97.0%, a positive predictive value of 99.2%, and a negative predictive value of 91.4%.
CONCLUSION


An ODI < 5 predicts an AHI < 5 with high sensitivity and specificity when measured simultaneously using the same oximeter during PM recording.",2019,"Using this cutoff in the test set provided a sensitivity of 97.7%, a specificity of 97.0%, a positive predictive value of 99.2%, and a negative predictive value of 91.4%.
","['Three thousand four hundred thirteen PM recordings', 'obstructive sleep apnea']",[],"['apnea hypopnea index (AHI', 'oxygen desaturation index (ODI']","[{'cui': 'C4517731', 'cui_str': 'Three thousand four hundred'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]",[],"[{'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0153202,"Using this cutoff in the test set provided a sensitivity of 97.7%, a specificity of 97.0%, a positive predictive value of 99.2%, and a negative predictive value of 91.4%.
","[{'ForeName': 'Timon M', 'Initials': 'TM', 'LastName': 'Fabius', 'Affiliation': 'Department of Pulmonology, Medisch Spectrum Twente, Onderzoeksbureau Longgeneeskunde, P.O. Box 50000, 7500 KA, Enschede, the Netherlands. T.Fabius@mst.nl.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Benistant', 'Affiliation': 'Department of Pulmonology, Medisch Spectrum Twente, Onderzoeksbureau Longgeneeskunde, P.O. Box 50000, 7500 KA, Enschede, the Netherlands.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Bekkedam', 'Affiliation': 'Department of Pulmonology, Medisch Spectrum Twente, Onderzoeksbureau Longgeneeskunde, P.O. Box 50000, 7500 KA, Enschede, the Netherlands.'}, {'ForeName': 'Job', 'Initials': 'J', 'LastName': 'van der Palen', 'Affiliation': 'Medical School Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Frans H C', 'Initials': 'FHC', 'LastName': 'de Jongh', 'Affiliation': 'Department of Pulmonology, Medisch Spectrum Twente, Onderzoeksbureau Longgeneeskunde, P.O. Box 50000, 7500 KA, Enschede, the Netherlands.'}, {'ForeName': 'Michiel M M', 'Initials': 'MMM', 'LastName': 'Eijsvogel', 'Affiliation': 'Department of Pulmonology, Medisch Spectrum Twente, Onderzoeksbureau Longgeneeskunde, P.O. Box 50000, 7500 KA, Enschede, the Netherlands.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-018-1654-2']
2671,31417102,A descriptive follow-up interview study assessing patient-centred outcomes: Salford Lung Study in Asthma (SLS Asthma).,"The Salford Lung Study in Asthma (SLS Asthma) was a multicentre, randomised, controlled, open-label trial that assessed initiating once-daily, single-inhaler fluticasone furoate/vilanterol (FF/VI) 100 μg/25 μg or 200 μg/25 μg versus continuing usual care. A subgroup (n = 400) from SLS Asthma was enrolled in this exploratory, interview-based follow-up study. Quantitative and qualitative data were collected via questionnaires. The primary objective was to capture patient-centred outcomes (symptom experience, quality of life [QoL], disease management behaviours) and patient experience. Secondary objectives were to assess the correlation of patient-reported outcomes with pre-defined variables from SLS Asthma (Asthma Control Test [ACT] score). The follow-up sample was representative of the SLS Asthma population; half reported asthma improvement during the study. Breathlessness was the most likely symptom to improve (47.8% of patients reported improvement). Most patients reported 'no change' in overall QoL (57.5%) and daily life domains (functioning 66.3%, activities 68.3%, relationships 86.8%, psychological 68.5%). Functioning was reported as the most frequently improved domain (29.8% of patients). Perceived improvement in asthma control (42.5%) and confidence (37.3%) was frequent. ACT responders (defined as patients achieving an ACT score ≥20 and/or an increase of ≥3 in ACT score from baseline at Week 52) were more likely to report asthma improvement (88.7% of patients reporting 'a lot' of improvement) than non-responders. Patients' asthma experiences generally improved during SLS Asthma. Clinical improvements were often associated with perceived improvement by patients, particularly among ACT responders.",2019,"Most patients reported 'no change' in overall QoL (57.5%) and daily life domains (functioning 66.3%, activities 68.3%, relationships 86.8%, psychological 68.5%).","['μg/25\u2009μg or 200', 'A subgroup (n\u2009=\u2009400) from SLS Asthma was enrolled in this exploratory, interview-based follow-up study', 'Asthma (SLS Asthma']",['fluticasone furoate/vilanterol (FF/VI) 100'],"['daily life domains', 'ACT score', 'Breathlessness', 'capture patient-centred outcomes (symptom experience, quality of life [QoL], disease management behaviours) and patient experience', 'overall QoL', 'SLS Asthma (Asthma Control Test [ACT] score']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0376636', 'cui_str': 'Disease Management'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2733224', 'cui_str': 'Asthma control test score'}]",400.0,0.0674969,"Most patients reported 'no change' in overall QoL (57.5%) and daily life domains (functioning 66.3%, activities 68.3%, relationships 86.8%, psychological 68.5%).","[{'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Doward', 'Affiliation': 'RTI Health Solutions, Manchester, UK.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Svedsater', 'Affiliation': 'GlaxoSmithKline plc., Brentford, UK. henrik.x.svedsater@gsk.com.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Whalley', 'Affiliation': 'RTI Health Solutions, Manchester, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Crawford', 'Affiliation': 'RTI Health Solutions, Manchester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leather', 'Affiliation': 'GlaxoSmithKline plc., Brentford, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Lay-Flurrie', 'Affiliation': 'GlaxoSmithKline plc., Uxbridge, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Bosanquet', 'Affiliation': 'Imperial College London, London, UK.'}]",NPJ primary care respiratory medicine,['10.1038/s41533-019-0142-x']
2672,30609439,Results of a Phase II Study to Determine the Efficacy and Safety of Genetically Engineered Allogeneic Human Chondrocytes Expressing TGF-β1.,"Genetically engineered chondrocytes virally transduced with a transforming growth factor (TGF)- β 1 (TG-C [TissueGene-C]) expression vector have been shown to have potential benefits in the nonoperative management of knee osteoarthritis. Previous literature has reported on safe dosages of TG-C. Therefore, the purpose of this study was to evaluate the Phase II results and a 24-month efficacy of this injectable mixture compared with placebo in patients with Kellgren-Lawrence (K-L) grade III knee osteoarthritis. Specifically, we assessed (1) functional outcomes, (2) pain scores, (3) adverse events (AEs), and (4) magnetic resonance imaging (MRIs) findings. We performed a multicenter, double-blinded, placebo-controlled, and randomized study of adults who had K-L grade III knee osteoarthritis. A total of 102 patients were 2:1 randomized to TG-C at a dose of 3.0 × 10 7  cells, or placebo injections between May 1, 2011 and October 31, 2012. Outcomes analyzed were knee joint function, pain, quality of life, adverse events, and MRI findings using the whole-organ magnetic resonance imaging score (WORMS) system. There were significant improvements in the International Knee Documentation Committee (IKDC) and visual analogue scale (VAS) scores in the TG-C cohort, when compared with the placebo cohort at weeks 12, 52, 72, and 104 ( p  < 0.05). No severe AEs were observed. Common AEs were arthralgia, joint inflammation, and joint effusion which were similar between both cohorts. Whole-knee MRIs at 12 months showed less progression of cartilage damage, infrapatellar fat pad-synovitis, and effusion-synovitis in the TG-C cohort. Patients who received TG-C had significant improvements in IKDC and VAS scores. These patients also reported less severe and frequent pain. Additionally, fewer patients treated with TG-C showed progression of cartilage damage, as well as less progression of infrapatellar fat pad synovitis and effusion-synovitis. Furthermore, treatment with TG-C was generally well tolerated with minor AEs. Therefore, based on these results, TG-C appears to be a safe and effective modality for the management of K-L grade III osteoarthritis.",2020,"There were significant improvements in the International Knee Documentation Committee (IKDC) and visual analogue scale (VAS) scores in the TG-C cohort, when compared with the placebo cohort at weeks 12, 52, 72, and 104 ( p  < 0.05).","['A total of 102 patients', 'adults who had K-L grade III knee osteoarthritis', 'patients with Kellgren-Lawrence (K-L) grade III knee osteoarthritis']","['TG-C', 'placebo', 'transforming growth factor (TGF)- β 1 (TG-C [TissueGene-C]) expression vector', 'Allogeneic Human Chondrocytes']","['International Knee Documentation Committee (IKDC) and visual analogue scale (VAS) scores', 'progression of cartilage damage', 'arthralgia, joint inflammation, and joint effusion', 'IKDC and VAS scores', 'severe and frequent pain', 'assessed (1) functional outcomes, (2) pain scores, (3) adverse events (AEs), and (4) magnetic resonance imaging (MRIs) findings', 'Efficacy and Safety', 'knee joint function, pain, quality of life, adverse events, and MRI findings using the whole-organ magnetic resonance imaging score (WORMS) system', 'progression of cartilage damage, infrapatellar fat pad-synovitis, and effusion-synovitis']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040691', 'cui_str': 'Animal growth regulators, transforming growth factors'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0442335', 'cui_str': 'Vectors (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0549421', 'cui_str': 'Cartilage damage'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C1253936', 'cui_str': 'Hydrarthrosis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0224706', 'cui_str': 'Structure of infrapatellar fat pad'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0013687', 'cui_str': 'Effusion (morphologic abnormality)'}]",102.0,0.147669,"There were significant improvements in the International Knee Documentation Committee (IKDC) and visual analogue scale (VAS) scores in the TG-C cohort, when compared with the placebo cohort at weeks 12, 52, 72, and 104 ( p  < 0.05).","[{'ForeName': 'Bumsup', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': 'Kolon Life Science, Inc., Gwacheon, Gyeonggi, Republic of Korea.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Parvizi', 'Affiliation': 'Rothman Institute Philadelphia, Pennsylvania.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Bramlet', 'Affiliation': 'Department of Orthopaedic Surgery, Pinellas Park, Pinellas Park, Florida.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Romness', 'Affiliation': 'Department of Orthopaedic Surgery, OrthoVirginia, Arlington, Virginia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Guermazi', 'Affiliation': 'Quantitative Imaging Center, Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Moon', 'Initials': 'M', 'LastName': 'Noh', 'Affiliation': 'Kolon Life Science, Inc., Gwacheon, Gyeonggi, Republic of Korea.'}, {'ForeName': 'Nipun', 'Initials': 'N', 'LastName': 'Sodhi', 'Affiliation': 'Department of Orthopaedic Surgery, Lenox Hill Hospital, Northwell Health, New York, New York.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Khlopas', 'Affiliation': 'Department of Orthopaedic Surgery, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Mont', 'Affiliation': 'Department of Orthopaedic Surgery, Lenox Hill Hospital, Northwell Health, New York, New York.'}]",The journal of knee surgery,['10.1055/s-0038-1676803']
2673,31059351,Anodal Transcranial Direct Current Stimulation to the Left Rostrolateral Prefrontal Cortex Selectively Improves Source Memory Retrieval.,"Functional neuroimaging studies have consistently implicated the left rostrolateral prefrontal cortex (RLPFC) as playing a crucial role in the cognitive operations supporting episodic memory and analogical reasoning. However, the degree to which the left RLPFC causally contributes to these processes remains underspecified. We aimed to assess whether targeted anodal stimulation-thought to boost cortical excitability-of the left RLPFC with transcranial direct current stimulation (tDCS) would lead to augmentation of episodic memory retrieval and analogical reasoning task performance in comparison to cathodal stimulation or sham stimulation. Seventy-two healthy adult participants were evenly divided into three experimental groups. All participants performed a memory encoding task on Day 1, and then on Day 2, they performed continuously alternating tasks of episodic memory retrieval, analogical reasoning, and visuospatial perception across two consecutive 30-min experimental sessions. All groups received sham stimulation for the first experimental session, but the groups differed in the stimulation delivered to the left RLPFC during the second session (either sham, 1.5 mA anodal tDCS, or 1.5 mA cathodal tDCS). The experimental group that received anodal tDCS to the left RLPFC during the second session demonstrated significantly improved episodic memory source retrieval performance, relative to both their first session performance and relative to performance changes observed in the other two experimental groups. Performance on the analogical reasoning and visuospatial perception tasks did not exhibit reliable changes as a result of tDCS. As such, our results demonstrate that anodal tDCS to the left RLPFC leads to a selective and robust improvement in episodic source memory retrieval.",2019,Performance on the analogical reasoning and visuospatial perception tasks did not exhibit reliable changes as a result of tDCS.,['Seventy-two healthy adult participants'],"['anodal tDCS', 'Anodal Transcranial Direct Current Stimulation', 'transcranial direct current stimulation (tDCS']","['analogical reasoning and visuospatial perception tasks', 'episodic memory source retrieval performance, relative to both their first session performance and relative to performance changes']","[{'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",72.0,0.0121424,Performance on the analogical reasoning and visuospatial perception tasks did not exhibit reliable changes as a result of tDCS.,"[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Westphal', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Tiffany E', 'Initials': 'TE', 'LastName': 'Chow', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Ngoy', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Xiaoye', 'Initials': 'X', 'LastName': 'Zuo', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Liao', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Laryssa A', 'Initials': 'LA', 'LastName': 'Storozuk', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Megan A K', 'Initials': 'MAK', 'LastName': 'Peters', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Wu', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Rissman', 'Affiliation': 'University of California, Los Angeles.'}]",Journal of cognitive neuroscience,['10.1162/jocn_a_01421']
2674,31954724,"Effects of Tubing Type, Operating Parameters, and Surfactants on Particle Formation During Peristaltic Filling Pump Processing of a mAb Formulation.","Filling pump operation is an important cause of particle formation in therapeutic protein formulations. The goals of the present study were to investigate the impacts of peristaltic filling pump tubing type, pump operating parameters (acceleration and velocity), and formulation on both nanoparticle and microparticle formation in water, placebo, and a 120 mg/mL mAb drug formulation. Microparticles were quantified using flow imaging microscopy and light obscuration, and nanoparticles were counted with nanoparticle tracking analysis. Pumping of all solutions through Pharmed® tubing resulted in much higher particle levels than processing with Accusil™ or Masterflex® tubing. Pump acceleration did not measurably affect particle levels in pumped solutions, but in some cases, a relatively high pumping velocity of 400 rpm enhanced nanoparticle formation. The presence of surfactants reduced pumping-induced particle formation in the mAb solution, and the effects of 4 different surfactants tested were similar. Biophysical properties (secondary and tertiary structure, and thermal stability) of the protein in solution were not altered by pumping. Overall, this study demonstrates that investigations of pumping parameters and formulations using both nanoparticle and microparticle measurement methods are important for understanding pumping-induced particle formation and developing effective control strategies.",2020,Pumping of all solutions through Pharmed® tubing resulted in much higher particle levels than processing with Accusil™ or Masterflex® tubing.,[],"['placebo, and a 120 mg/mL mAb drug formulation']",['Particle Formation'],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0524527', 'cui_str': 'Drug Formulation'}]","[{'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}]",400.0,0.0386615,Pumping of all solutions through Pharmed® tubing resulted in much higher particle levels than processing with Accusil™ or Masterflex® tubing.,"[{'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Her', 'Affiliation': ''}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Tanenbaum', 'Affiliation': ''}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Bandi', 'Affiliation': ''}, {'ForeName': 'Theodore W', 'Initials': 'TW', 'LastName': 'Randolph', 'Affiliation': ''}, {'ForeName': 'Renuka', 'Initials': 'R', 'LastName': 'Thirumangalathu', 'Affiliation': ''}, {'ForeName': 'Krishna M G', 'Initials': 'KMG', 'LastName': 'Mallela', 'Affiliation': ''}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Carpenter', 'Affiliation': ''}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Elias', 'Affiliation': ''}]",Journal of pharmaceutical sciences,['10.1016/j.xphs.2020.01.009']
2675,32128561,Effect of a Home Pregnancy Test Intervention on Cohort Retention and Pregnancy Detection: A Randomized Trial.,"We conducted a parallel, nonblinded randomized trial to assess whether offering home pregnancy tests (HPTs) to preconception cohort study participants influenced cohort retention or pregnancy detection. Pregnancy Study Online participants were female, aged 21-45 years, attempting pregnancy, and not using fertility treatment. At enrollment (2017-2018), 1,493 participants with 6 or fewer cycles of attempt time were randomly assigned with 50% probability to receive 12 Clearblue visual HPTs plus the standard protocol (n = 720) or the standard protocol alone (n = 773). Women completed bimonthly questionnaires for 12 months or until conception, whichever came first. In intent-to-treat analyses, retention (≥1 follow-up) was higher in the HPT arm (n = 598; 83%) than the standard protocol arm (n = 535 (69%); mean difference = 15%, 95% CI: 10, 19). Mean time at first pregnancy testing was identical in both arms (2 days before expected menses), as was mean gestational weeks at first positive pregnancy test (4 weeks). Conception was reported by 78% of women in the HPT arm and 75% in the standard protocol arm. Spontaneous abortion was reported by 21% in the HPT arm (mean gestational weeks = 7) and 21% in the standard protocol arm (mean gestational weeks = 6). Randomization of HPTs was associated with greater cohort retention but had little impact on incidence or timing of pregnancy detection.",2020,"In intent-to-treat analyses, retention (≥1 follow-ups) was higher in the HPT arm (","['Pregnancy Study Online (PRESTO) participants were female, aged 21-45 years, attempting pregnancy, and not using fertility treatment', '1,493 participants with ≤6 cycles of attempt time']","['home pregnancy tests (HPT', 'Home Pregnancy Test Intervention', 'Clearblue visual HPTs plus the standard protocol (N=720) or the standard protocol']","['Mean time at first pregnancy testing', 'Conception', 'cohort retention or pregnancy detection', 'Cohort Retention and Pregnancy Detection', 'Spontaneous abortion']","[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0445107', 'cui_str': 'Not used (qualifier value)'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0032976', 'cui_str': 'Pregnancy Tests'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0860096', 'cui_str': 'Primigravida (finding)'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}]",1493.0,0.233746,"In intent-to-treat analyses, retention (≥1 follow-ups) was higher in the HPT arm (","[{'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Wise', 'Affiliation': 'Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Tanran R', 'Initials': 'TR', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Sydney K', 'Initials': 'SK', 'LastName': 'Willis', 'Affiliation': 'Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Amelia K', 'Initials': 'AK', 'LastName': 'Wesselink', 'Affiliation': 'Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Rothman', 'Affiliation': 'Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Hatch', 'Affiliation': 'Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts.'}]",American journal of epidemiology,['10.1093/aje/kwaa027']
2676,30836801,Radiographic and clinical outcomes following etanercept monotherapy in Japanese methotrexate-naïve patients with active rheumatoid arthritis.,"Objectives:  Compare outcomes with methotrexate (MTX) or etanercept (ETN) monotherapy in Japanese patients with active rheumatoid arthritis (RA) who were MTX-naïve or with intolerance or inadequate response to prior MTX (MTX-IR). Methods:   Post hoc  analysis of a phase 3 study comparing MTX, ETN 10 mg twice weekly, and ETN 25 mg twice weekly in Japanese patients with RA. Disease activity was evaluated using American College of Rheumatology (ACR) scores and 28-joint Disease Activity Score (DAS28), radiographic progression evaluated using van der Heijde's modified Total Sharp Score (mTSS), and functional status evaluated using Health Assessment Questionnaire Disability Index (HAQ-DI). Results:  Among MTX-naïve and MTX-IR patients, greater proportions of those randomized to either ETN group achieved ACR20, ACR50, ACR70, DAS28 ≤3.2 or <2.6, clinically relevant inhibition of mTSS changes, and reductions in HAQ-DI compared with MTX at the majority of time points. There were very few clinically meaningful differences between ETN groups for any of the variables evaluated. Conclusion:  ETN monotherapy was more effective than MTX in both MTX-naïve and MTX-IR patients, with very few clinically meaningful differences between ETN 10 mg and ETN 25 mg when given twice weekly. The relative benefits of ETN were greater in MTX-naïve patients than MTX-IR patients. ClinicalTrials.gov identifier NCT00445770.",2020,"There were very few clinically meaningful differences between ETN groups for any of the variables evaluated.
","['Japanese methotrexate-naïve patients with active rheumatoid arthritis', 'Japanese patients with active rheumatoid arthritis (RA) who were MTX-naïve or with intolerance or inadequate response to prior MTX (MTX-IR', 'Japanese patients with RA']","['ETN', 'etanercept monotherapy', 'MTX, ETN 10\u2009mg twice weekly, and ETN', 'methotrexate (MTX) or etanercept (ETN) monotherapy', 'MTX']","['HAQ-DI', 'ACR20, ACR50, ACR70, DAS28', 'Disease activity', ""American College of Rheumatology (ACR) scores and 28-joint Disease Activity Score (DAS28), radiographic progression evaluated using van der Heijde's modified Total Sharp Score (mTSS), and functional status evaluated using Health Assessment Questionnaire Disability Index (HAQ-DI""]","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}]","[{'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0102923', 'cui_str': 'HAQ'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0557775', 'cui_str': 'Van (physical object)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1444775', 'cui_str': 'Sharp'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire (assessment scale)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0248031,"There were very few clinically meaningful differences between ETN groups for any of the variables evaluated.
","[{'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Miyasaka', 'Affiliation': 'Department of Medicine and Rheumatology, Graduate School, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Pedersen', 'Affiliation': 'Department of Biostatistics, Pfizer Inc., Collegeville, PA, USA.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Sugiyama', 'Affiliation': 'Clinical Statistics, Biometrics & Data Management, Pfizer R&D Japan, Tokyo, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Hirose', 'Affiliation': 'Immunology and Inflammation Medical Affairs, Pfizer Biopharmaceuticals Group, Pfizer Japan Inc., Tokyo, Japan.'}]",Modern rheumatology,['10.1080/14397595.2019.1589918']
2677,31597485,The Role of Dispensing Device and Label Warnings on Dosing for Sunscreen Application: A Randomized Trial.,"Drug manufacturers are expected to provide labeling information needed to yield safe and effective product use. However, it is not clear that consumers dose sunscreen, an over-the-counter drug, appropriately; in fact, existing evidence suggests underdosing as a common phenomenon. The objective of this study was to evaluate the effect of dispensing device and labeling on self-administered doses of sunscreen in young adults. To investigate those effects, a 2 × 2 factorial laboratory experiment crossing dispensing device (two levels) with labeling treatment (two levels) was conducted. Participants applied sunscreen from each of the four treatments; dosing concentration, measured in mg/cm 2 , served as the response variable. Participants ( n  = 94) were recruited on the campuses of Michigan State University (East Lansing, MI) and California Polytechnic State University (San Luis Obispo, CA). Each participant applied sunscreen from each unique treatment to sites on their arms and legs (four applications). Postapplication, a survey was completed to characterize demographics, risk perception, and sunscreen use patterns. Results indicate participants applied approximately 30% less sunscreen from the pump bottles than the squeeze bottles (difference estimate of 0.3059 mg/cm 2 , standard error = 0.0607,  p  < .0001); there was no evidence of a difference based on label treatments. Post hoc recognition tests indicated only 55% of participants were able to recognize the two experimental labels they had viewed immediately following sunscreen application. Sunscreen application density was directly related to level of worry regarding skin cancer and frequency of sunscreen use (α = .05). Our results suggest the dispensing device used to deliver sunscreen impacts the dosage amount consumers apply.",2020,Post hoc recognition tests indicated only 55% of participants were able to recognize the two experimental labels they had viewed immediately following sunscreen application.,"['young adults', 'Participants ( n  = 94) were recruited on the campuses of Michigan State University (East Lansing, MI) and California Polytechnic State University (San Luis Obispo, CA']","['dispensing device and labeling on self-administered doses of sunscreen', 'Dispensing Device and Label Warnings']",[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0557813', 'cui_str': 'Polytechnic (environment)'}, {'cui': 'C0445527', 'cui_str': 'Luis (qualifier value)'}]","[{'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0038818', 'cui_str': 'Sunscreens'}]",[],,0.0519314,Post hoc recognition tests indicated only 55% of participants were able to recognize the two experimental labels they had viewed immediately following sunscreen application.,"[{'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Harben', 'Affiliation': 'Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Shelby', 'Initials': 'S', 'LastName': 'Robinson', 'Affiliation': 'Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'de la Fuente', 'Affiliation': 'California Polytechnic State University, San Luis Obispo, CA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bix', 'Affiliation': 'Michigan State University, East Lansing, MI, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198119879739']
2678,31883370,"Bezlotoxumab for the Prevention of Recurrent Clostridioides difficile Infection: 12-Month Observational Data From the Randomized Phase III Trial, MODIFY II.","From Monoclonal Antibodies for C. difficile Therapy II, no participants (n = 0/69) with a sustained clinical cure through 12 weeks following bezlotoxumab infusion experienced recurrent Clostridioides difficile infection (rCDI) after 9 months (versus actoxumab + bezlotoxumab, n = 2/65; versus placebo, n = 1/34). Bezlotoxumab's efficacy appears to be due to prevention rather than delayed onset of rCDI. Clinical Trials Registration. NCT01513239.",2020,"From Monoclonal Antibodies for C. difficile Therapy II, no participants (n = 0/69) with a sustained clinical cure through 12 weeks following bezlotoxumab infusion experienced recurrent Clostridioides difficile infection (rCDI) after 9 months (versus actoxumab + bezlotoxumab, n = 2/65; versus placebo, n = 1/34).",[],"['bezlotoxumab', 'actoxumab + bezlotoxumab', 'placebo', 'Bezlotoxumab']",['recurrent Clostridioides difficile infection (rCDI'],[],"[{'cui': 'C4291320', 'cui_str': 'bezlotoxumab'}, {'cui': 'C4308583', 'cui_str': 'actoxumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",,0.0939758,"From Monoclonal Antibodies for C. difficile Therapy II, no participants (n = 0/69) with a sustained clinical cure through 12 weeks following bezlotoxumab infusion experienced recurrent Clostridioides difficile infection (rCDI) after 9 months (versus actoxumab + bezlotoxumab, n = 2/65; versus placebo, n = 1/34).","[{'ForeName': 'Ellie J C', 'Initials': 'EJC', 'LastName': 'Goldstein', 'Affiliation': 'R. M. Alden Research Laboratory, Santa Monica, California, USA.'}, {'ForeName': 'Diane M', 'Initials': 'DM', 'LastName': 'Citron', 'Affiliation': 'R. M. Alden Research Laboratory, Santa Monica, California, USA.'}, {'ForeName': 'Dale N', 'Initials': 'DN', 'LastName': 'Gerding', 'Affiliation': 'Hines Veterans Affairs Hospital, Hines, Illinois, USA.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Wilcox', 'Affiliation': 'Leeds Teaching Hospitals and University of Leeds, Leeds, West Yorkshire, United Kingdom.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Gabryelski', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Pedley', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zeng', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Dorr', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz1151']
2679,32089078,Effect of Yoga on Antiretroviral Adherence Postincarceration in HIV+ Individuals.,"The negative impacts of stress on antiretroviral therapy (ART) adherence and the many stressors faced by people returning from incarceration support the need for stress reduction interventions for this population. We hypothesized that 37 returning citizens living with HIV and substance use problems randomized to a 12-session weekly yoga intervention would experience improved ART adherence, lower viral loads, and lower heart rate and blood pressure as compared to 36 people randomized to treatment as usual (TAU). We found that ART adherence increased for yoga participants and decreased for TAU participants. There were no significant changes for viral load, heart rate, or blood pressure. The lack of statistically significant effects may be due to a small sample size and enrollment of people largely in HIV treatment. Studies with larger sample sizes and participants exhibiting low ART adherence are warranted to better understand yoga's impact.",2020,"There were no significant changes for viral load, heart rate, or blood pressure.","['37 returning citizens living with HIV and substance use problems', 'HIV+ Individuals']",[],"['ART adherence, lower viral loads, and lower heart rate and blood pressure', 'viral load, heart rate, or blood pressure', 'ART adherence']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",[],"[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",,0.0951712,"There were no significant changes for viral load, heart rate, or blood pressure.","[{'ForeName': 'Alexandra S', 'Initials': 'AS', 'LastName': 'Wimberly', 'Affiliation': 'University of Maryland School of Social Work, Baltimore, MD, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gross', 'Affiliation': 'Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Layde', 'Affiliation': 'Peace Corps, Masasi, Mtwara, Tanzania.'}]",Journal of correctional health care : the official journal of the National Commission on Correctional Health Care,['10.1177/1078345819897924']
2680,32134163,KEYNOTE-032: A Randomized Phase I Study of Pembrolizumab in Chinese Patients with Advanced Non-Small-Cell Lung Cancer.,"LESSONS LEARNED


Results of the KEYNOTE-032 study showed that the safety and pharmacokinetic profiles of pembrolizumab in Chinese patients were comparable with those observed in international studies, and antitumor activity was encouraging. These data support further evaluation of pembrolizumab to improve clinical outcomes in Chinese patients with advanced non-small cell lung cancer.
BACKGROUND


The KEYNOTE-032 study evaluated pembrolizumab pharmacokinetics and clinical outcomes in Chinese patients with locally advanced and/or metastatic non-small-cell lung cancer (NSCLC) and prior treatment failure and/or ineligibility for standard therapy.
METHODS


Patients were randomized 1:1:1 to pembrolizumab 2 mg/kg, 10 mg/kg, or 200 mg every 3 weeks (up to 35 cycles). Safety and pharmacokinetics were primary endpoints; antitumor activity was a secondary endpoint.
RESULTS


A total of 42 of 44 randomized patients received pembrolizumab treatment (2 mg/kg, n = 14; 10 mg/kg, n = 13; 200 mg, n = 15). Treatment-related adverse events (AEs) occurred in 29 of 42 (69%) patients (grade 3-4, 4/42 [10%]); 5 (12%) had immune-mediated AEs and infusion reactions. Pembrolizumab single dose half-life following 2 mg/kg, 10 mg/kg, and 200 mg was 15.1, 15.8, and 12.3 days, respectively. Serum exposure at the doses studied (range, 2-10 mg/kg) was approximately linear; steady-state area under the curve 0-21 days  (95% confidence interval [CI]) was 730.9 (627.4-851.6), 2,819.2 (2,009.4-3,955.4), and 931.0 (724.4-1,196.6) μg•day/mL, respectively. After 7.9 (range, 0.7-13.1) months median follow-up overall, objective response rate was 14.3% (95% CI, 5.4%-28.5%); median progression-free survival was 2.1 (95% CI, 2.1-4.2) months, and median overall survival was not reached (95% CI, 6.6 months-not reached).
CONCLUSION


Pembrolizumab had manageable toxicity, linear serum exposure, and encouraging antitumor activity in Chinese patients with advanced NSCLC.",2020,"Treatment-related adverse events (AEs) occurred in 29 of 42 (69%) patients (grade 3-4, 4/42 [10%]); 5 (12%) had immune-mediated AEs and infusion reactions.","['Chinese patients with advanced non-small cell lung cancer', 'Chinese patients with locally advanced and/or metastatic non-small-cell lung cancer (NSCLC) and prior treatment failure', 'Patients', 'Chinese patients with advanced NSCLC', 'Chinese patients', 'Chinese Patients with Advanced Non-Small-Cell Lung Cancer']","['pembrolizumab treatment', 'pembrolizumab', 'Pembrolizumab']","['adverse events (AEs', 'objective response rate', 'safety and pharmacokinetic profiles of pembrolizumab', 'antitumor activity', 'immune-mediated AEs and infusion reactions', 'median overall survival', 'Safety and pharmacokinetics', 'median progression-free survival', 'manageable toxicity, linear serum exposure', 'Serum exposure']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer (disorder)'}, {'cui': 'C0162643'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C2368034', 'cui_str': 'Adverse reaction caused by drug or medicament administered by infusion'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",44.0,0.397296,"Treatment-related adverse events (AEs) occurred in 29 of 42 (69%) patients (grade 3-4, 4/42 [10%]); 5 (12%) had immune-mediated AEs and infusion reactions.","[{'ForeName': 'Yuxiang', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Wenfeng', 'Initials': 'W', 'LastName': 'Fang', 'Affiliation': ""Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yunpeng', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Shaodong', 'Initials': 'S', 'LastName': 'Hong', 'Affiliation': ""Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Xie', 'Affiliation': ""MSD China, Beijing, People's Republic of China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': ""MSD China, Shanghai, People's Republic of China.""}, {'ForeName': 'HaoJin', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ""MSD China, Beijing, People's Republic of China.""}, {'ForeName': 'Hongyun', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': ""Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}]",The oncologist,['10.1634/theoncologist.2020-0067']
2681,30795718,Using a fotonovela to battle crystal meth in South Africa.,"This study evaluated the effects of a health-related fotonovela about crystal meth (S-methamphetamine hydrochloride) among ""Colored"" people (an ethnic label for people of mixed race) in the Western Cape province of South Africa. Crystal meth use is most common among Colored people in this province and it is considered a major social problem. The fotonovela was compared to a no-message control group and a traditional brochure in a randomized controlled trial ( N =  303). The fotonovela outperformed the control condition for knowledge level and it outperformed the traditional brochure on intention toward starting conversations about crystal meth. Especially readers with relatively low levels of education clearly preferred the fotonovela over the traditional brochure.",2020,The fotonovela outperformed the control condition for knowledge level and it outperformed the traditional brochure on intention toward starting conversations about crystal meth.,"['Colored"" people (an ethnic label for people of mixed race) in the Western Cape province of South Africa', 'South Africa']",['health-related fotonovela about crystal meth (S-methamphetamine hydrochloride'],[],"[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0454728', 'cui_str': 'Cape Province (geographic location)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0427896', 'cui_str': 'Crystal - human material (substance)'}, {'cui': 'C0282233', 'cui_str': 'Methamphetamine Hydrochloride'}]",[],,0.0330641,The fotonovela outperformed the control condition for knowledge level and it outperformed the traditional brochure on intention toward starting conversations about crystal meth.,"[{'ForeName': 'Burt', 'Initials': 'B', 'LastName': 'Davis', 'Affiliation': 'Africa Centre for HIV/AIDS Management, Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'Carel', 'Initials': 'C', 'LastName': 'Jansen', 'Affiliation': 'University of Groningen, Faculty of Arts, Communication and Information Studies, Groningen, the Netherlands.'}]",Journal of ethnicity in substance abuse,['10.1080/15332640.2019.1568335']
2682,31917621,"Thrombomodulin Alfa for Acute Exacerbation of Idiopathic Pulmonary Fibrosis. A Randomized, Double-Blind Placebo-controlled Trial.","Rationale:  Acute exacerbation during the course of idiopathic pulmonary fibrosis causes a poor prognosis. Coagulation abnormalities and endothelial damage are involved in its pathogenesis. Thrombomodulin alfa, a recombinant human soluble thrombomodulin, has anticoagulant and antiinflammatory effects. Several clinical studies have shown that thrombomodulin alfa may improve survival of acute exacerbation. Objectives:  To determine the efficacy and safety of thrombomodulin alfa compared with placebo in acute exacerbation of idiopathic pulmonary fibrosis. Methods:  This randomized, double-blind placebo-controlled phase 3 study conducted at 27 sites in Japan involved patients with an acute exacerbation of idiopathic pulmonary fibrosis. Subjects were randomized 1:1 to receive placebo or thrombomodulin alfa (380 U/kg/d for 14 d by intravenous drip infusion). All subjects were treated with high-dose corticosteroid therapy. The primary endpoint was the survival proportion on Day 90. Measurements and Main Results:  Of the 82 randomized subjects, 77 completed the study and were included in the full analysis set (thrombomodulin alfa,  n  = 40; placebo,  n  = 37). The survival proportions on Day 90 were 72.5% (29 of 40) in the thrombomodulin alfa group and 89.2% (33 of 37) in the placebo group, a difference of -16.7 percentage points (95% confidence interval, -33.8 to 0.4%;  P  = 0.0863). In the safety population ( n  = 80), bleeding adverse events occurred in the thrombomodulin alfa group (10 of 42; 23.8%) and the placebo group (4 of 38; 10.5%). Conclusions:  Thrombomodulin alfa did not improve the 90-day survival proportion. The present results suggest that the use of thrombomodulin alfa for the treatment of acute exacerbation of idiopathic pulmonary fibrosis not be recommended.Clinical trial registered with www.clinicaltrials.gov (NCT02739165).",2020,"The survival proportion on Day 90 was 72.5% (29/40) in the thrombomodulin alfa group and 89.2% (33/37) in the placebo group, a difference of -16.7 percentage points (95% CI, -33.8% to 0.4%, p=0.0863).","['Acute Exacerbation of Idiopathic Pulmonary Fibrosis', 'acute exacerbation of idiopathic pulmonary fibrosis', '27 sites in Japan involved patients with an acute exacerbation of idiopathic pulmonary fibrosis']","['Placebo', 'Thrombomodulin alfa', 'corticosteroid therapy', 'placebo', 'Thrombomodulin alfa, a recombinant human soluble thrombomodulin', 'thrombomodulin alfa', 'placebo or thrombomodulin alfa']","['survival proportion', '90-day survival proportion', 'survival proportion on Day 90', 'bleeding adverse events']","[{'cui': 'C2242482', 'cui_str': 'Exacerbation of idiopathic pulmonary fibrosis'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",77.0,0.706193,"The survival proportion on Day 90 was 72.5% (29/40) in the thrombomodulin alfa group and 89.2% (33/37) in the placebo group, a difference of -16.7 percentage points (95% CI, -33.8% to 0.4%, p=0.0863).","[{'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Kondoh', 'Affiliation': 'Department of Respiratory Medicine and Allergy, Tosei General Hospital, Aichi, Japan.'}, {'ForeName': 'Arata', 'Initials': 'A', 'LastName': 'Azuma', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Clincal Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ogura', 'Affiliation': 'Division of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Kanagawa, Japan.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Respiratory Medicine, Toho University Omori Medical Center, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Tsushima', 'Affiliation': 'Department of Pulmonary Medicine, School of Medicine, International University of Health and Welfare, Chiba, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Johkoh', 'Affiliation': 'Department of Radiology, Kansai Rosai Hospital, Hyogo, Japan.'}, {'ForeName': 'Kiminori', 'Initials': 'K', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Radiology and.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Ichikado', 'Affiliation': 'Division of Respiratory Medicine, Saiseikai Kumamoto Hospital, Kumamoto, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Matsuzawa', 'Affiliation': 'Department of Respiratory Medicine, Toho University Medical Center-Sakura Hospital, Chiba, Japan.'}, {'ForeName': 'Takefumi', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization, Ibarakihigashi National Hospital, Ibaraki, Japan.'}, {'ForeName': 'Kazuma', 'Initials': 'K', 'LastName': 'Kishi', 'Affiliation': 'Department of Respiratory Medicine, Toho University Omori Medical Center, Tokyo, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Tomii', 'Affiliation': 'Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Hyogo, Japan.'}, {'ForeName': 'Noriho', 'Initials': 'N', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Aoshima', 'Affiliation': 'Department of Pulmonology, Kameda Medical Center, Chiba, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Araya', 'Affiliation': 'Division of Respiratory Diseases, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shinyu', 'Initials': 'S', 'LastName': 'Izumi', 'Affiliation': 'Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Machiko', 'Initials': 'M', 'LastName': 'Arita', 'Affiliation': 'Department of Respiratory Medicine, Kurashiki Central Hospital, Okayama, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Abe', 'Affiliation': 'Department of Respirology, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Yamauchi', 'Affiliation': 'Division of Pulmonary Medicine, Department of Medicine, Jichi Medical University, Tochigi, Japan.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Shindoh', 'Affiliation': 'Department of Respiratory Medicine, Ogaki Municipal Hospital, Gifu, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Suda', 'Affiliation': 'Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, Shizuoka, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Okamoto', 'Affiliation': 'Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Ebina', 'Affiliation': 'Department of Respiratory Medicine, Tohoku Medical and Pharmaceutical University, Miyagi, Japan.'}, {'ForeName': 'Yoshihito', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'Department of Respiratory Medicine, Japan Railway Tokyo General Hospital, Tokyo, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Tohda', 'Affiliation': 'Department of Respiratory Medicine and Allergology, Faculty of Medicine, Kindai University, Osaka, Japan.'}, {'ForeName': 'Tetsuji', 'Initials': 'T', 'LastName': 'Kawamura', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Himeji Medical Center, Hyogo, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Taguchi', 'Affiliation': 'Department of Respiratory Medicine, Tenri Hospital, Nara, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ishii', 'Affiliation': 'Department of Respiratory Medicine, Fukuoka University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Naozumi', 'Initials': 'N', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Aichi, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Abe', 'Affiliation': 'Department of Respiratory Medicine, Tokyo Medical University Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Respiratory Medicine and Allergy, Tosei General Hospital, Aichi, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Tagawa', 'Affiliation': 'Asahi-Kasei Pharma Corporation, Tokyo, Japan; and.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Bessho', 'Affiliation': 'Asahi-Kasei Pharma Corporation, Tokyo, Japan; and.'}, {'ForeName': 'Natsuki', 'Initials': 'N', 'LastName': 'Yamamori', 'Affiliation': 'Asahi-Kasei Pharma Corporation, Tokyo, Japan; and.'}, {'ForeName': 'Sakae', 'Initials': 'S', 'LastName': 'Homma', 'Affiliation': 'Department of Advanced and Integrated Interstitial Lung Diseases Research, School of Medicine, Toho University, Tokyo, Japan.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201909-1818OC']
2683,31403668,A Web-Based HIV/STD Prevention Intervention for Divorced or Separated Older Women.,"BACKGROUND AND OBJECTIVE


Sexually transmitted diseases (STDs) are increasing among older adults concomitant with a rise in divorce after the age of 50 years. The objective of this study was to examine the effectiveness of a web-based human immunodeficiency virus (HIV)/STD risk reduction intervention for divorced and separated women aged more than 50 years.
RESEARCH DESIGN AND METHODS


Two hundred nineteen divorced or separated women, aged 50 years and older, participated in 60-day randomized pre-post control group study. Recruitment occurred via health agencies in Boston and Columbia, SC, and Craigslist advertisements placed in Boston, Columbia, Charleston, New York City, Washington DC, Baltimore, Chicago, Atlanta, Orlando, and Miami.
RESULTS


Intervention group reported greater intention to practice safe sex compared to the control group (B = .55, p = .03). Intention to practice safe sex differed by perceived stress (B = .15, p = .005), with no difference between control and intervention groups for those with low levels of stress. For high levels of stress, intervention group reported greater intention to practice safe sex compared to controls. Sexual risk was reduced by 6.10 points (SD: 1.10), and self-efficacy for sexual discussion was increased by 2.65 points (SD: 0.56) in the intervention group.
DISCUSSION AND IMPLICATIONS


A web-based intervention represents a promising tool to reduce HIV/STD risk among older women. Offering HIV/STD education in the context of other topics of interest to at-risk older women, such as divorce, may solve the problem of at-risk older women not seeking out prevention information due to lack of awareness of their heightened risk.",2020,Intention to practice safe sex differed by perceived stress,"['Two hundred nineteen divorced or separated women, aged 50 years and older, participated in 60-day randomized pre-post control group study', 'older adults concomitant with a rise in divorce after the age of 50 years', 'Divorced or Separated Older Women', 'older women', 'divorced and separated women aged more than 50 years']","['STD Prevention Intervention', 'web-based human immunodeficiency virus (HIV)/STD risk reduction intervention']","['Sexual risk', 'self-efficacy for sexual discussion', 'greater intention to practice safe sex']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0086170', 'cui_str': 'Divorced'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0521999', 'cui_str': 'Age more than 50 years (finding)'}]","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0597728', 'cui_str': 'Responsible Sex'}]",,0.0513786,Intention to practice safe sex differed by perceived stress,"[{'ForeName': 'Patricia Flynn', 'Initials': 'PF', 'LastName': 'Weitzman', 'Affiliation': 'Environment and Health Group, Cambridge, Massachusetts.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Environment and Health Group, Cambridge, Massachusetts.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Kogelman', 'Affiliation': ""Infectious Diseases Clinic, Traveler's Health Service, Tufts University School of Medicine, Boston, Massachusetts.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Mack', 'Affiliation': 'Environment and Health Group, Cambridge, Massachusetts.'}, {'ForeName': 'Jie Yang', 'Initials': 'JY', 'LastName': 'Sharir', 'Affiliation': 'Environment and Health Group, Cambridge, Massachusetts.'}, {'ForeName': 'Sara Romero', 'Initials': 'SR', 'LastName': 'Vicente', 'Affiliation': 'Environment and Health Group, Cambridge, Massachusetts.'}, {'ForeName': 'Sue E', 'Initials': 'SE', 'LastName': 'Levkoff', 'Affiliation': 'Environment and Health Group, Cambridge, Massachusetts.'}]",The Gerontologist,['10.1093/geront/gnz098']
2684,31779535,The Green Light for Green Dot: A Qualitative Study of Factors Influencing Adoption of an Efficacious Violence Prevention Program in High School Settings.,"The purpose of this qualitative study was to investigate factors influencing the adoption of an effective bystander-based sexual violence prevention intervention. High schools participating in a cluster-randomized controlled trial that found significant declines in sexual violence over time and with full implementation were invited to adopt this program (Green Dot) at no cost. Three emergent themes arose from interviews with 10 intervention implementers. These findings have implications for researchers, practitioners, and high school administrators and may facilitate future program marketing efforts and the development and testing of strategies for targeted dissemination of this and other bystander programs for violence.",2019,The purpose of this qualitative study was to investigate factors influencing the adoption of an effective bystander-based sexual violence prevention intervention.,['High School Settings'],"['Green Light for Green Dot', 'bystander-based sexual violence prevention intervention']",['sexual violence'],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C1306567', 'cui_str': 'Green light (physical force)'}, {'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C3489576', 'cui_str': 'Sexual Violence'}]",,0.0177074,The purpose of this qualitative study was to investigate factors influencing the adoption of an effective bystander-based sexual violence prevention intervention.,"[{'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Davidov', 'Affiliation': 'West Virginia University, Morgantown, USA.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': 'NYU Winthrop Hospital, Mineola, USA.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Bush', 'Affiliation': 'University of Kentucky, Lexington, USA.'}, {'ForeName': 'Ann L', 'Initials': 'AL', 'LastName': 'Coker', 'Affiliation': 'University of Kentucky, Lexington, USA.'}]",Violence against women,['10.1177/1077801219886377']
2685,31823403,A personalized computational model predicts cancer risk level of oral potentially malignant disorders and its web application for promotion of non-invasive screening.,"BACKGROUND


Despite their high accuracy to recognize oral potentially malignant disorders (OPMDs) with cancer risk, non-invasive oral assays are poor in discerning whether the risk is high or low. However, it is critical to identify the risk levels, since high-risk patients need active intervention, while low-risk ones simply need to be follow-up. This study aimed at developing a personalized computational model to predict cancer risk level of OPMDs and explore its potential web application in OPMDs screening.
METHODS


Each enrolled patient was subjected to the following procedure: personal information collection, non-invasive oral examination, oral tissue biopsy and histopathological analysis, treatment, and follow-up. Patients were randomly divided into a training set (N = 159) and a test set (N = 107). Random forest was used to establish classification models. A baseline model (model-B) and a personalized model (model-P) were created. The former used the non-invasive scores only, while the latter was incremented with appropriate personal features.
RESULTS


We compared the respective performance of cancer risk level prediction by model-B, model-P, and clinical experts. Our data suggested that all three have a similar level of specificity around 90%. In contrast, the sensitivity of model-P is beyond 80% and superior to the other two. The improvement of sensitivity by model-P reduced the misclassification of high-risk patients as low-risk ones. We deployed model-P in web.opmd-risk.com, which can be freely and conveniently accessed.
CONCLUSION


We have proposed a novel machine-learning model for precise and cost-effective OPMDs screening, which integrates clinical examinations, machine learning, and information technology.",2020,"In contrast, the sensitivity of model-P is beyond 80% and superior to the other two.",[],[],[],[],[],[],,0.0145534,"In contrast, the sensitivity of model-P is beyond 80% and superior to the other two.","[{'ForeName': 'Xiangjian', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Changlei', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': 'State Key Laboratory of Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zhou', 'Affiliation': 'Department of Oral Medicine, School and Hospital of Stomatology, Wuhan University, Wuhan, China.'}, {'ForeName': 'Lanyan', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Oral Pathology, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Qinghong', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Department of Oral and Maxillofacial surgery, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'State Key Laboratory of Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jiahong', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'State Key Laboratory of Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Mei', 'Affiliation': 'State Key Laboratory of Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Oral Medicine, North Sichuan Medical College, Nanchong, China.'}, {'ForeName': 'Xueke', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'State Key Laboratory of Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Fanglong', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'State Key Laboratory of Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'State Key Laboratory of Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yiqing', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'State Key Laboratory of Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Qizhi', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Chengdu University of TCM, Chengdu, China.'}, {'ForeName': 'Jiaxin', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'Department of Preventive Dentistry, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Hu', 'Affiliation': 'Department of Preventive Dentistry, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'State Key Laboratory of Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'Hefei National Laboratory for Physical Sciences at Microscale and School of Life Science, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'State Key Laboratory of Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}]",Journal of oral pathology & medicine : official publication of the International Association of Oral Pathologists and the American Academy of Oral Pathology,['10.1111/jop.12983']
2686,31146534,A Multiple Dose Phase 1 Assessment of Rilpivirine Long Acting in a Model of Preexposure Prophylaxis Against HIV.,"The MWRI-01 study characterized the safety, acceptability, pharmacokinetic (PK), and pharmacodynamic (PD) profile of rilpivirine (RPV) long acting (LA) in a model of preexposure prophylaxis (PrEP). Prospective, open-label Phase 1 study. The safety and acceptability of three repeated doses of RPV LA were monitored. Blood, tissue (rectal, cervical, and vaginal), and biological fluids (vaginal and endocervical) were collected at baseline and at 1- to 2-month intervals throughout the study for PK and PD assessment. Eight women and four men received three intramuscular doses of 1,200 mg of RPV LA given 8 weeks apart. There were a total of 195 adverse events (AEs) reported, of which 138 (70.8%) were Grade 1 and 55 (28.2%) were Grade 2. The most common AE was injection site pain. Geometric mean (90% confidence interval) plasma RPV concentrations at 56 days after the first and third doses were 39 (33-45) ng/mL (female)/29 (17-40) ng/mL (male) and 59 (45-62) ng/mL (female)/40 (30-51) ng/mL (male), respectively. Exposure to RPV LA was associated with significant inhibition of HIV-1 BaL  viral replication in the  ex vivo  rectal explant model ( p  < .0001) that persisted for up to 4 months after the third dose of RPV LA. In contrast, no viral suppression was seen in cervicovaginal tissue. Multiple dose administration of RPV LA was safe and well tolerated, and was associated with prolonged suppression of viral replication in rectal explant tissue.",2019,Multiple dose administration of RPV LA was safe and well tolerated and was associated with prolonged suppression of viral replication in rectal explant tissue.,"['Eight women and four men', 'female) / 29 (17-40) ng/mL (male) and 59 (45-62) ng/mL (female']","['RPV LA', 'Rilpivirine', 'rilpivirine (RPV) long acting (LA']","['safe and well tolerated', 'HIV-1BaL viral replication', 'viral suppression', 'safety, acceptability, pharmacokinetic (PK), and pharmacodynamic (PD) profile', 'plasma RPV concentrations', 'Geometric mean (GM', 'Blood, tissue (rectal, cervical, and vaginal), and biological fluids (vaginal and endocervical', 'safety and acceptability']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C1566826', 'cui_str': 'Rilpivirine'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C4521006', 'cui_str': 'Endocervical'}]",8.0,,Multiple dose administration of RPV LA was safe and well tolerated and was associated with prolonged suppression of viral replication in rectal explant tissue.,"[{'ForeName': 'Ross D', 'Initials': 'RD', 'LastName': 'Cranston', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Charlene S', 'Initials': 'CS', 'LastName': 'Dezzutti', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Siegel', 'Affiliation': 'Magee Women Research Institute, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jarret', 'Initials': 'J', 'LastName': 'Engstrom', 'Affiliation': 'Magee Women Research Institute, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Cory', 'Initials': 'C', 'LastName': 'Shetler', 'Affiliation': 'Magee Women Research Institute, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Richardson-Harman', 'Affiliation': 'Alpha StatConsult, LLC, Damascus, Maryland.'}, {'ForeName': 'Kaleab Z', 'Initials': 'KZ', 'LastName': 'Abebe', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Back', 'Affiliation': 'University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Else', 'Affiliation': 'University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Deidre', 'Initials': 'D', 'LastName': 'Egan', 'Affiliation': 'University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Saye', 'Initials': 'S', 'LastName': 'Khoo', 'Affiliation': 'University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Egan', 'Affiliation': 'University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Stall', 'Affiliation': 'University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': 'Janssen Research and Development, Beerse, Belgium.'}, {'ForeName': 'Rhonda M', 'Initials': 'RM', 'LastName': 'Brand', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Urvi M', 'Initials': 'UM', 'LastName': 'Parikh', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'McGowan', 'Affiliation': 'Orion Biotechnology, Ottawa, Canada.'}]",AIDS research and human retroviruses,['10.1089/AID.2018.0265']
2687,32212275,A Randomized Double-Blind Placebo-Controlled First-In-Human Phase 1 Trial of TransCon PTH in Healthy Adults.,"TransCon PTH is a sustained-release, essentially inactive prodrug transiently bound to an inert carrier, designed to release PTH(1-34), and in development for hypoparathyroidism (HP). This phase 1, randomized, placebo-controlled, single and multiple ascending dose (SAD and MAD, respectively) trial evaluated safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of TransCon PTH in healthy adults. SAD and MAD cohorts consisted of 10 subjects (eight active, two placebo) who received up to seven single or six multiple ascending doses of TransCon PTH, respectively. TransCon PTH doses ranged from 3.5 to 124 μg PTH(1-34) for the SAD cohorts and 3.5 to 24 μg PTH(1-34)/day for the MAD cohorts. The primary PK endpoint was Free PTH. The PD endpoints included albumin adjusted serum calcium (sCa), fractional excretion of calcium (FECa), intact endogenous PTH(1-84), bone turnover markers, renal tubular maximum reabsorption of phosphate/glomerular filtration rate (TMP/GFR), serum phosphate (sP) and magnesium, and 1,25 dihydroxyvitamin D. TransCon PTH was generally well tolerated; there were no drug-related serious adverse events (SAEs), and all AEs were transient in nature. Free PTH demonstrated an effective half-life of approximately 60 hours and a dose-dependent, sustained exposure with an infusion-like profile within the calculated physiologic range for active PTH at steady-state. Albumin-adjusted sCa demonstrated a dose-dependent, sustained response with complete control of FECa despite modest hypercalcemia at higher doses. Renal tubular maximum reabsorption of phosphate/glomerular filtration rate (TMP/GFR) showed a dose-dependent decrease, resulting in a dose-dependent decrease in sP. TransCon PTH administered daily for 10 days showed no increase in the osteoblastic bone formation markers, serum bone-specific alkaline phosphatase (BSAP) or P1NP, or the osteoclastic bone resorption marker, urine NTx, but modestly and transiently increased the osteoclast marker, serum CTx. These phase 1 data support TransCon PTH as a daily replacement therapy for HP providing physiological levels of PTH 24 hours per day and advancement into phase 2 clinical development. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.",2020,,['Healthy Adults'],"['Placebo', 'TransCon PTH']",[],"[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}]",[],,0.2371,,"[{'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Karpf', 'Affiliation': 'Ascendis Pharma, Inc., Palo Alto, CA, USA.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Pihl', 'Affiliation': 'Ascendis Pharma A/S, Hellerup, Denmark.'}, {'ForeName': 'Sanchita', 'Initials': 'S', 'LastName': 'Mourya', 'Affiliation': 'Ascendis Pharma, Inc., Palo Alto, CA, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Mortensen', 'Affiliation': 'Ascendis Pharma, Inc., Palo Alto, CA, USA.'}, {'ForeName': 'Eshwari', 'Initials': 'E', 'LastName': 'Kovoor', 'Affiliation': 'Ascendis Pharma, Inc., Palo Alto, CA, USA.'}, {'ForeName': 'Denka', 'Initials': 'D', 'LastName': 'Markova', 'Affiliation': 'Ascendis Pharma, Inc., Palo Alto, CA, USA.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Leff', 'Affiliation': 'Ascendis Pharma, Inc., Palo Alto, CA, USA.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4016']
2688,32126551,Frequency and Clinical Impact of Serious Adverse Events on Post-Stroke Recovery with NeuroAiD (MLC601) versus Placebo: The CHInese Medicine Neuroaid Efficacy on Stroke Recovery Study.,"BACKGROUND


Most comparative clinical trials are designed to assess the treatment effect for efficacy endpoints, with less emphasis on the analysis of safety outcomes. However, an extensive analysis of safety data could demonstrate beneficial results in terms of effectiveness by reducing serious adverse events (SAEs), and their unfavourable clinical impact on the study population. We aimed to conduct an exploratory analysis of the CHInese Medicine Neuroaid Efficacy on Stroke recovery (CHIMES) study safety database comparing the frequency of SAEs and their clinical impacts among subjects having received MLC601 or placebo during the first 3 months post-stroke.
METHODS


Analyses were performed by using the safety database of the multicentre, randomised, double-blind, placebo-controlled CHIMES study of 3 months of NeuroAiD versus placebo in subjects with acute ischaemic stroke of intermediate severity in the preceding 72 h. SAEs as reported by investigators at any time-point during the 3-month study were analysed on their frequency and that of any of their outcomes (death, and life threatening, new and/or prolonged hospitalisation, disability, and medical importance, in surviving subjects), as well as their time to onset and resolution.
RESULTS


Of the 1,099 subjects in the CHIMES study, 1,087 were included in the safety analysis (MLC601 = 542) and (placebo = 545); the 12 who did not receive study treatment were excluded. There was a total of 135 subjects with SAEs (MLC601 = 60, placebo = 75). At baseline, overall, subjects with SAEs were older and had lower MMSE score. In the MLC601 group, they had higher NIHSS score, and more frequently a history of ischaemic heart disease and hyperlipidaemia. The number of SAEs per subjects was statistically significantly lower in the MLC601 group than placebo one, especially for subjects with ≥2 SAEs (6.7 vs. 29.3%; p < 0.001). This benefit was seen throughout the study period and during the initial hospitalisation. The main clinical impact of SAEs was an increase in hospitalisation time, reduced in the MLC601 arm with the rate of subjects hospitalised for a prolonged period being significantly threefold lower in surviving subjects (1.1 vs. 3.7%; p < 0.01).
CONCLUSIONS


This post hoc analysis of SAEs from the CHIMES study database shows that subjects receiving a 3-month course of MLC601 experienced fewer SAEs, with lower rates of harmful clinical impacts, especially in terms of hospitalisation duration. These findings could translate to a benefit in terms of reduction of both healthcare burden and additional medical costs.",2020,"The main clinical impact of SAEs was an increase in hospitalisation time, reduced in the MLC601 arm with the rate of subjects hospitalised for a prolonged period being significantly threefold lower in surviving subjects (1.1 vs. 3.7%; p < 0.01).
","[' 1,087 were included in the safety analysis (MLC601 = 542) and (placebo = 545); the 12 who did not receive study treatment were excluded', 'subjects having received', '135 subjects with SAEs (MLC601 = 60, placebo = 75', 'subjects with acute ischaemic stroke of intermediate severity in the preceding 72 h. SAEs as reported by investigators at any time-point during the 3-month study', 'during the first 3\xa0months post-stroke', '1,099 subjects in the CHIMES study']","['MLC601 or placebo', 'placebo', 'NeuroAiD (MLC601', 'NeuroAiD versus placebo', 'MLC601', 'Placebo']","['MMSE score', 'NIHSS score', 'hospitalisation time', 'outcomes (death, and life threatening, new and/or prolonged hospitalisation, disability, and medical importance, in surviving subjects', 'ischaemic heart disease and hyperlipidaemia', 'number of SAEs']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517809', 'cui_str': 'Five hundred and forty-five'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2745174', 'cui_str': 'MLC 601'}]","[{'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",135.0,0.177987,"The main clinical impact of SAEs was an increase in hospitalisation time, reduced in the MLC601 arm with the rate of subjects hospitalised for a prolonged period being significantly threefold lower in surviving subjects (1.1 vs. 3.7%; p < 0.01).
","[{'ForeName': 'Narayanaswamy', 'Initials': 'N', 'LastName': 'Venketasubramanian', 'Affiliation': 'Raffles Neuroscience Centre, Raffles Hospital, Singapore, Singapore, drnvramani@gmail.com.'}, {'ForeName': 'Rajesh B', 'Initials': 'RB', 'LastName': 'Moorakonda', 'Affiliation': 'Singapore Clinical Research Institute, Singapore, Singapore.'}, {'ForeName': 'Qingshu', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Singapore Clinical Research Institute, Singapore, Singapore.'}, {'ForeName': 'Christopher L H', 'Initials': 'CLH', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmacology, National University of Singapore, Clinical Research Centre, Singapore, Singapore.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Cerebrovascular diseases (Basel, Switzerland)",['10.1159/000506070']
2689,32109318,"Randomised, controlled, double-blind study of combination therapy of oral tranexamic acid and topical hydroquinone in the treatment of melasma.","BACKGROUND/OBJECTIVES


Melasma is a common pigmentary disorder for which oral tranexamic acid has shown some efficacy in previous studies. The aim of this study was to assess the effectiveness of oral tranexamic acid in combination with hydroquinone cream in the treatment of melasma.
METHODS


Subjects with moderate-to-severe melasma were enrolled. Group A received hydroquinone 4% cream, sunscreen and oral tranexamic acid, while Group B received hydroquinone 4% cream, sunscreen and placebo capsules for 3 months. All subjects had an additional 3-month follow-up visit on sunscreen alone. The primary outcome measure was change in modified Melasma Area and Severity Index (mMASI) score. In addition, the melanin index was measured using a mexameter.
RESULTS


Fifty subjects were enrolled, and all completed the study. There was a 55% reduction in mMASI after 3 months from mean 8.96 (SD 2.45) to 4.0 (SD 1.6) in Group A compared to 10.9% from mean 8.53 (SD 2.04) to 7.6 (SD 2.0) in Group B. Three months after oral and topical therapy was discontinued, there was a 42% decrease in mMASI compared to baseline in Group A (mean 5.1 SD 1.7) vs. 4.7% in Group B (mean 8.1 SD 2.0). No serious adverse events were observed.
CONCLUSIONS


A combination of oral tranexamic acid and topical hydroquinone is more effective than hydroquinone alone in the treatment of melasma.",2020,A combination of oral tranexamic acid and topical hydroquinone is more effective than hydroquinone alone in the treatment of melasma.,"['melasma', 'Fifty subjects were enrolled, and all completed the study', 'Subjects with moderate-to-severe melasma were enrolled']","['hydroquinone 4% cream, sunscreen and placebo', 'hydroquinone 4% cream, sunscreen and oral tranexamic acid', 'hydroquinone cream', 'tranexamic acid', 'hydroquinone', 'oral tranexamic acid and topical hydroquinone', 'oral tranexamic acid']","['mMASI', 'melanin index', 'serious adverse events', 'change in modified Melasma Area and Severity Index (mMASI) score']","[{'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0020307', 'cui_str': 'Quinols'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0038818', 'cui_str': 'Sunscreens'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C0025196', 'cui_str': 'Melanins'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",50.0,0.202074,A combination of oral tranexamic acid and topical hydroquinone is more effective than hydroquinone alone in the treatment of melasma.,"[{'ForeName': 'Nahla', 'Initials': 'N', 'LastName': 'Shihab', 'Affiliation': 'Department of Dermatology and Venereology, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Joedo', 'Initials': 'J', 'LastName': 'Prihartono', 'Affiliation': 'Department of Community Medicine, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Tovar-Garza', 'Affiliation': 'Department of Dermatology, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Triana', 'Initials': 'T', 'LastName': 'Agustin', 'Affiliation': 'Department of Dermatology and Venereology, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Legiawati', 'Affiliation': 'Department of Dermatology and Venereology, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Amit G', 'Initials': 'AG', 'LastName': 'Pandya', 'Affiliation': 'Department of Dermatology, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}]",The Australasian journal of dermatology,['10.1111/ajd.13267']
2690,32067251,Randomized Controlled Trial of a Multilevel Intervention to Address Social Determinants of Refugee Mental Health.,"Understanding processes that support the well-being of the unprecedented numbers of forcibly displaced people throughout the world is essential. Growing evidence documents post-migration stressors related to marginalization as key social determinants of refugee mental health. The goal of this RCT was to rigorously test a social justice approach to reducing high rates of distress among refugees in the United States. The 6-month multilevel, strengths-based Refugee Well-being Project (RWP) intervention brought together university students enrolled in a 2-semester course and recently resettled refugees to engage in mutual learning and collaborative efforts to mobilize community resources and improve community and systems responsiveness to refugees. Data collected from 290 Afghan, Great Lakes African, Iraqi, and Syrian refugees at four time points over 12 months were used to test the effectiveness of RWP to reduce distress (depression and anxiety symptoms) and increase protective factors (English proficiency, social support, connection to home and American cultures). Intention-to-treat analyses using multilevel modeling revealed significant intervention effects for all hypothesized outcomes. Results provide evidence to support social justice approaches to improving refugee mental health. Findings have implications for refugees worldwide, and for other immigrant and marginalized populations who experience inequities in resources and disproportionate exposure to trauma/stress.",2020,Understanding processes that support the well-being of the unprecedented numbers of forcibly displaced people throughout the world is essential.,[],"['RWP', 'strengths-based Refugee Well-being Project (RWP) intervention', 'Multilevel Intervention']","['protective factors (English proficiency, social support, connection to home and American cultures', 'distress (depression and anxiety symptoms']",[],"[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}]","[{'cui': 'C0679688', 'cui_str': 'Protective Factors'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0037438'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",,0.0395065,Understanding processes that support the well-being of the unprecedented numbers of forcibly displaced people throughout the world is essential.,"[{'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Goodkind', 'Affiliation': 'Department of Sociology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Bybee', 'Affiliation': 'Department of Psychology, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Julia Meredith', 'Initials': 'JM', 'LastName': 'Hess', 'Affiliation': 'Department of Pediatrics, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Suha', 'Initials': 'S', 'LastName': 'Amer', 'Affiliation': 'Center for Social Policy, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ndayisenga', 'Affiliation': 'Center for Social Policy, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'R Neil', 'Initials': 'RN', 'LastName': 'Greene', 'Affiliation': 'Department of Sociology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Ryeora', 'Initials': 'R', 'LastName': 'Choe', 'Affiliation': 'Department of Sociology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Isakson', 'Affiliation': 'Department of Psychiatry, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Baca', 'Affiliation': 'Center for Social Policy, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Mahbooba', 'Initials': 'M', 'LastName': 'Pannah', 'Affiliation': 'Center for Social Policy, University of New Mexico, Albuquerque, NM, USA.'}]",American journal of community psychology,['10.1002/ajcp.12418']
2691,32267235,Nurse-Physician Communication Team Training in Virtual Reality Versus Live Simulations: Randomized Controlled Trial on Team Communication and Teamwork Attitudes.,"BACKGROUND


Interprofessional team training is needed to improve nurse-physician communication skills that are lacking in clinical practice. Using simulations has proven to be an effective learning approach for team training. Yet, it has logistical constraints that call for the exploration of virtual environments in delivering team training.
OBJECTIVE


This study aimed to evaluate a team training program using virtual reality vs conventional live simulations on medical and nursing students' communication skill performances and teamwork attitudes.
METHODS


In June 2018, the authors implemented nurse-physician communication team training using communication tools. A randomized controlled trial study was conducted with 120 undergraduate medical and nursing students who were randomly assigned to undertake team training using virtual reality or live simulations. The participants from both groups were tested on their communication performances through team-based simulation assessments. Their teamwork attitudes were evaluated using interprofessional attitude surveys that were administered before, immediately after, and 2 months after the study interventions.
RESULTS


The team-based simulation assessment revealed no significant differences in the communication performance posttest scores (P=.29) between the virtual and simulation groups. Both groups reported significant increases in the interprofessional attitudes posttest scores from the baseline scores, with no significant differences found between the groups over the 3 time points.
CONCLUSIONS


Our study outcomes did not show an inferiority of team training using virtual reality when compared with live simulations, which supports the potential use of virtual reality to substitute conventional simulations for communication team training. Future studies can leverage the use of artificial intelligence technology in virtual reality to replace costly human-controlled facilitators to achieve better scalability and sustainability of team-based training in interprofessional education.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04330924; https://clinicaltrials.gov/ct2/show/NCT04330924.",2020,The team-based simulation assessment revealed no significant differences in the communication performance posttest scores (P=.29) between the virtual and simulation groups.,['120 undergraduate medical and nursing students'],"['Virtual Reality Versus Live Simulations', 'team training program using virtual reality vs conventional live simulations', 'team training using virtual reality or live simulations']","['communication performance posttest scores', 'interprofessional attitudes posttest scores']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.09034,The team-based simulation assessment revealed no significant differences in the communication performance posttest scores (P=.29) between the virtual and simulation groups.,"[{'ForeName': 'Sok Ying', 'Initials': 'SY', 'LastName': 'Liaw', 'Affiliation': 'Alice Lee Centre for Nursing Studies, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Sim Win', 'Initials': 'SW', 'LastName': 'Ooi', 'Affiliation': 'National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Khairul Dzakirin Bin', 'Initials': 'KDB', 'LastName': 'Rusli', 'Affiliation': 'Alice Lee Centre for Nursing Studies, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Tang Ching', 'Initials': 'TC', 'LastName': 'Lau', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Wilson Wai San', 'Initials': 'WWS', 'LastName': 'Tam', 'Affiliation': 'Alice Lee Centre for Nursing Studies, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Wei Ling', 'Initials': 'WL', 'LastName': 'Chua', 'Affiliation': 'Alice Lee Centre for Nursing Studies, National University of Singapore, Singapore, Singapore.'}]",Journal of medical Internet research,['10.2196/17279']
2692,32005332,"Developing and Testing a Novel, Computerized Insomnia and Anxiety Intervention to Reduce Safety Aids Among an at-Risk Student Sample: A Randomized Controlled Trial.","Anxiety and insomnia disorders are two of the most common and costly mental health conditions. They are frequently comorbid, but current treatments do not target both. To streamline treatment, we developed a computerized intervention targeting a transdiagnostic factor, safety aids (cognitive or behavioral strategies used to cope with distress that paradoxically exacerbate symptoms). We conducted a randomized controlled trial to determine the acceptability and efficacy of this brief one-session intervention. Young adult undergraduates (N = 61) with elevated subclinical anxiety and insomnia were randomized to receive the anxiety-insomnia intervention or a physical health control condition. Participants were followed for 1 month and completed self-report measures. Analyses indicated that participants found the intervention acceptable, credible, and engaging. Analyses revealed the active intervention reduced sleep- and anxiety-related safety aids, with medium to large effect sizes. Findings suggest that targeting safety aids for anxiety and insomnia is acceptable and effective in reducing the target mechanism, safety aids, as well as worry. Future research should replicate these findings within a clinical sample and with a longer-term follow-up.",2020,"Analyses revealed the active intervention reduced sleep- and anxiety-related safety aids, with medium to large effect sizes.",['Young adult undergraduates (N = 61) with elevated subclinical anxiety and insomnia'],"['anxiety-insomnia intervention or a physical health control condition', 'Computerized Insomnia and Anxiety Intervention', 'computerized intervention targeting a transdiagnostic factor, safety aids (cognitive or behavioral strategies']","['sleep- and anxiety-related safety aids', 'acceptability and efficacy', 'Anxiety and insomnia disorders']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]",61.0,0.0931799,"Analyses revealed the active intervention reduced sleep- and anxiety-related safety aids, with medium to large effect sizes.","[{'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Short', 'Affiliation': 'Florida State University; Medical University of South Carolina.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Schmidt', 'Affiliation': 'Florida State University. Electronic address: schmidt@psy.fsu.edu.'}]",Behavior therapy,['10.1016/j.beth.2019.05.012']
2693,32123969,"Impact of liver tumour burden, alkaline phosphatase elevation, and target lesion size on treatment outcomes with  177 Lu-Dotatate: an analysis of the NETTER-1 study.","PURPOSE


To assess the impact of baseline liver tumour burden, alkaline phosphatase (ALP) elevation, and target lesion size on treatment outcomes with  177 Lu-Dotatate.
METHODS


In the phase 3 NETTER-1 trial, patients with advanced, progressive midgut neuroendocrine tumours (NET) were randomised to 177Lu-Dotatate (every 8 weeks, four cycles) plus octreotide long-acting release (LAR) or to octreotide LAR 60 mg. Primary endpoint was progression-free survival (PFS). Analyses of PFS by baseline factors, including liver tumour burden, ALP elevation, and target lesion size, were performed using Kaplan-Meier estimates; hazard ratios (HRs) with corresponding 95% CIs were estimated using Cox regression.
RESULTS


Significantly prolonged median PFS occurred with  177 Lu-Dotatate versus octreotide LAR 60 mg in patients with low (< 25%), moderate (25-50%), and high (> 50%) liver tumour burden (HR 0.187, 0.216, 0.145), and normal or elevated ALP (HR 0.153, 0.177), and in the presence or absence of a large target lesion (diameter > 30 mm; HR, 0.213, 0.063). Within the  177 Lu-Dotatate arm, no significant difference in PFS was observed amongst patients with low/moderate/high liver tumour burden (P = 0.7225) or with normal/elevated baseline ALP (P = 0.3532), but absence of a large target lesion was associated with improved PFS (P = 0.0222). Grade 3 and 4 liver function abnormalities were rare and did not appear to be associated with high baseline liver tumour burden.
CONCLUSIONS


177 Lu-Dotatate demonstrated significant prolongation in PFS versus high-dose octreotide LAR in patients with advanced, progressive midgut NET, regardless of baseline liver tumour burden, elevated ALP, or the presence of a large target lesion. Clinicaltrials.gov : NCT01578239, EudraCT: 2011-005049-11.",2020,"Grade 3 and 4 liver function abnormalities were rare and did not appear to be associated with high baseline liver tumour burden.
","['patients with advanced, progressive midgut neuroendocrine tumours (NET']","['octreotide LAR', 'octreotide long-acting release (LAR) or to octreotide LAR 60 mg']","['median PFS', 'PFS', 'progression-free survival (PFS', 'baseline liver tumour burden, alkaline phosphatase (ALP) elevation, and target lesion size', 'liver tumour burden, ALP elevation, and target lesion size', 'liver tumour burden']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0231052', 'cui_str': 'Primitive midgut structure'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine Tumors'}]","[{'cui': 'C0028833', 'cui_str': 'Octreotide'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0023903', 'cui_str': 'Neoplasms, Hepatic'}, {'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]",,0.355159,"Grade 3 and 4 liver function abnormalities were rare and did not appear to be associated with high baseline liver tumour burden.
","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Strosberg', 'Affiliation': 'Gastrointestinal Department/Neuroendocrine Tumor Division, Moffitt Cancer Center, Tampa, FL, USA. jonathan.strosberg@moffitt.org.'}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Kunz', 'Affiliation': 'Department of Medicine - Med/Oncology, Stanford University Medical Center, Stanford, CA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hendifar', 'Affiliation': 'Department of Internal Medicine/Hematology/Oncology, Cedars Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'Department of Gastrointestinal Medicinal Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bushnell', 'Affiliation': 'Department of Radiology, The University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Matthew H', 'Initials': 'MH', 'LastName': 'Kulke', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Baum', 'Affiliation': 'Department of Nuclear Medicine, Zentralklinik Bad Berka, Bad Berka, Germany.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Caplin', 'Affiliation': 'Department of Gastroenterology and Tumour Neuroendocrinology, Royal Free Hospital, London, UK.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Ruszniewski', 'Affiliation': 'Division of Gastroenterology and Pancreatology, Hôpital Beaujon, Clichy, France.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Delpassand', 'Affiliation': 'Department of Clinical Nuclear Medicine, Excel Diagnostics Imaging Clinic, Houston, TX, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Hobday', 'Affiliation': 'Department of Oncology, Mayo Clinic College of Medicine, Rochester, MN, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Verslype', 'Affiliation': 'Department of Hepatology, University Hospitals and KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Al', 'Initials': 'A', 'LastName': 'Benson', 'Affiliation': 'Hematology Oncology Division, Robert H. Lurie Comprehensive Cancer Center, Chicago, IL, USA.'}, {'ForeName': 'Rajaventhan', 'Initials': 'R', 'LastName': 'Srirajaskanthan', 'Affiliation': ""Department of Gastroenterology and General Internal Medicine, King's College Hospital - NHS Foundation Trust, London, UK.""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Pavel', 'Affiliation': 'Division of Hepatology and Gastroenterology, Charite-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Mora', 'Affiliation': 'Department of Nuclear Medicine, Hospital Universitari de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Berlin', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Grande', 'Affiliation': 'Department of Medical Oncology, MD Anderson Cancer Center, Madrid, Spain.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Reed', 'Affiliation': 'Department of Medical Oncology, Beatson Oncology Centre, Glasgow, UK.'}, {'ForeName': 'Ettore', 'Initials': 'E', 'LastName': 'Seregni', 'Affiliation': 'Department of Nuclear Medicine Therapy and Endocrinology, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Paganelli', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Severi', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Morse', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Metz', 'Affiliation': 'GI Division, Hospital of the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ansquer', 'Affiliation': 'Nuclear Medicine Department, Hôtel Dieu, University Hospital, Nantes, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Courbon', 'Affiliation': 'Medical Imaging, Oncology University Institut Claudius Regaud, Toulouse, France.'}, {'ForeName': 'Adil', 'Initials': 'A', 'LastName': 'Al-Nahhas', 'Affiliation': 'Division of Imaging and Interventional Radiology, Imperial College London, London, UK.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Baudin', 'Affiliation': 'Department of Endocrine Oncology and Nuclear Medicine, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giammarile', 'Affiliation': 'Department of Nuclear Sciences and Applications, International Atomic Energy Agency, Vienna, Austria.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Taïeb', 'Affiliation': 'Department of Nuclear Medicine, Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Mittra', 'Affiliation': 'Department of Nuclear Medicine, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Wolin', 'Affiliation': 'Department of Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': ""O'Dorisio"", 'Affiliation': 'Department of Internal Medicine, The University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Rachida', 'Initials': 'R', 'LastName': 'Lebtahi', 'Affiliation': 'Department of Nuclear Medicine, Royal Free Hospital, London, UK.'}, {'ForeName': 'Christophe M', 'Initials': 'CM', 'LastName': 'Deroose', 'Affiliation': 'Nuclear Medicine Department, University Hospitals and KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Chiara M', 'Initials': 'CM', 'LastName': 'Grana', 'Affiliation': 'Division of Nuclear Medicine, Istituto Europeo di Oncologia, Milan, Italy.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Bodei', 'Affiliation': 'Department of Nuclear Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Kjell', 'Initials': 'K', 'LastName': 'Öberg', 'Affiliation': 'Department of Endocrine Oncology, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Berna Degirmenci', 'Initials': 'BD', 'LastName': 'Polack', 'Affiliation': 'Department of Medical Information, Advanced Accelerator Applications, a Novartis Company, Geneva, Switzerland.'}, {'ForeName': 'Beilei', 'Initials': 'B', 'LastName': 'He', 'Affiliation': 'Advanced Accelerator Applications, a Novartis Company, Geneva, Switzerland.'}, {'ForeName': 'Maurizio F', 'Initials': 'MF', 'LastName': 'Mariani', 'Affiliation': 'Research and Development, Advanced Accelerator Applications, a Novartis Company, Geneva, Switzerland.'}, {'ForeName': 'Germo', 'Initials': 'G', 'LastName': 'Gericke', 'Affiliation': 'Research and Development, Advanced Accelerator Applications, a Novartis Company, Geneva, Switzerland.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Santoro', 'Affiliation': 'Department of Clinical Development, Advanced Accelerator Applications, a Novartis Company, Geneva, Switzerland.'}, {'ForeName': 'Jack L', 'Initials': 'JL', 'LastName': 'Erion', 'Affiliation': 'Advanced Accelerator Applications, a Novartis Company, Geneva, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ravasi', 'Affiliation': 'Research and Development, Advanced Accelerator Applications, a Novartis Company, Geneva, Switzerland.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Krenning', 'Affiliation': 'Department of Nuclear Medicine, Cyclotron Rotterdam BV, Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of nuclear medicine and molecular imaging,['10.1007/s00259-020-04709-x']
2694,32116212,Exercise therapy in fibromyalgia patients: comparison of a web-based intervention with usual care.,"OBJECTIVES


The aim of this study was to investigate the effectiveness of a web-based exercise intervention in improving the severity of symptoms in different health domains in patients with fibromyalgia (FM).
METHODS


Consecutive FM patients insufficiently responding to drug treatment (defined as a score of >4 on a numerical rating scale of pain) were enrolled in a web-based intervention group (Fibro-Web) and underwent a 24-week daily home exercise programme. They were evaluated through the revised Fibromyalgia Impact Questionnaire (FIQR) and the Modified Fibromyalgia Assessment Status questionnaire (Mod FAS) at baseline, and then every two weeks until the end of the programme. The outcomes were compared with those of patients receiving usual care.
RESULTS


The final analysis was based on 140 patients: 68 in the Fibro-Web group and 72 in the usual care group. At the end of the 24-week study period, the patients in the Fibro-Web group showed a significant improvement in overall and sub-scale scores of the FIQR (p=0.0279) and Mod FAS (p=0.0057), expressed as time-integrated values. This improvement started in the 16th week.
CONCLUSIONS


The use of a web-based daily exercise programme in FM patients significantly improves disease severity indices.",2020,"At the end of the 24-week study period, the patients in the Fibro-Web group showed a significant improvement in overall and sub-scale scores of the FIQR (p=0.0279) and Mod FAS (p=0.0057), expressed as time-integrated values.","['patients with fibromyalgia (FM', 'Consecutive FM patients insufficiently responding to drug treatment (defined as a score of >4 on a numerical rating scale of pain) were enrolled in a web-based intervention group (Fibro-Web) and underwent a', 'fibromyalgia patients', '140 patients: 68 in the Fibro-Web group and 72 in the usual care group']","['web-based exercise intervention', 'Exercise therapy', '24-week daily home exercise programme']","['overall and sub-scale scores of the FIQR (p=0.0279) and Mod FAS', 'revised Fibromyalgia Impact Questionnaire (FIQR) and the Modified Fibromyalgia Assessment Status questionnaire (Mod FAS', 'disease severity indices']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026766', 'cui_str': 'Organ Dysfunction Syndrome, Multiple'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",140.0,0.0585665,"At the end of the 24-week study period, the patients in the Fibro-Web group showed a significant improvement in overall and sub-scale scores of the FIQR (p=0.0279) and Mod FAS (p=0.0057), expressed as time-integrated values.","[{'ForeName': 'Fausto', 'Initials': 'F', 'LastName': 'Salaffi', 'Affiliation': 'Rheumatology Clinic, Dipartimento di Scienze Cliniche e Molecolari, Università Politecnica delle Marche, Jesi, Ancona, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Di Carlo', 'Affiliation': 'Rheumatology Clinic, Dipartimento di Scienze Cliniche e Molecolari, Università Politecnica delle Marche, Jesi, Ancona, Italy. dica.marco@yahoo.it.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Farah', 'Affiliation': 'Rheumatology Clinic, Dipartimento di Scienze Cliniche e Molecolari, Università Politecnica delle Marche, Jesi, Ancona, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Marotto', 'Affiliation': 'Rheumatology Unit, P. Dettori Hospital, AST Sardegna Tempio Pausanias, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Giorgi', 'Affiliation': 'Rheumatology Unit, Internal Medicine Department, ASST Fatebenefratelli-Sacco, Milano Statale University, School of Medicine, Milan, Italy.'}, {'ForeName': 'Piercarlo', 'Initials': 'P', 'LastName': 'Sarzi-Puttini', 'Affiliation': 'Rheumatology Unit, Internal Medicine Department, ASST Fatebenefratelli-Sacco, Milano Statale University, School of Medicine, Milan, Italy.'}]",Clinical and experimental rheumatology,[]
2695,31297752,A Cost-Effectiveness Analysis Comparing the VivaSight Double-Lumen Tube and a Conventional Double-Lumen Tube in Adult Patients Undergoing Thoracic Surgery Involving One-Lung Ventilation.,"BACKGROUND


One-lung ventilation (OLV) procedures are essential for most thoracic surgeries, and the most common method is intubation with a conventional double-lumen tube (cDLT) and bronchoscopy to verify correct tube placement.
OBJECTIVE


The objective of this study was to conduct a cost-effectiveness analysis comparing the VivaSight double-lumen tube (DL) and a cDLT for OLV procedures.
METHODS


A cost-effectiveness analysis was conducted from a healthcare sector perspective in Denmark using a decision analytic model to assess the potential effects and costs of using VivaSight-DL as an alternative to a cDLT with a reusable bronchoscope. Costs were determined using a micro-costing approach. The effectiveness measure was the number of times that fiberoptic confirmation of the tube placement during intubation or surgery was unnecessary and thus avoided. The effectiveness input was from a randomized controlled trial (n = 52). Both deterministic and probabilistic sensitivity analyses were conducted to assess the robustness of the results.
RESULTS


Fiberoptic confirmation of tube placement was only necessary in two (6.66%) procedures using VivaSight-DL. The cost of using VivaSight-DL was $US299.96 per procedure versus $US347.61 for a cDLT with a reusable bronchoscope. The incremental cost-effectiveness ratio was - $US51.06 per bronchoscopy avoided. The base-case analysis indicated that the use of VivaSight-DL was cost effective compared with the use of a cDLT with reusable bronchoscope. Sensitivity analyses showed that the results were robust and that VivaSight-DL was more effective and less costly.
CONCLUSION


This study suggests that VivaSight-DL is associated with cost savings and reductions in bronchoscope use to verify correct tube placement. The conclusion is based on the results from a single institution. To clarify whether VivaSight-DL is cost effective in larger or global clinical settings, further economic evaluations should be performed.",2020,"RESULTS


Fiberoptic confirmation of tube placement was only necessary in two (6.66%) procedures using VivaSight-DL.",['Adult Patients'],"['VivaSight double-lumen tube (DL', 'VivaSight-DL', 'VivaSight Double-Lumen Tube and a Conventional Double-Lumen Tube', 'Undergoing Thoracic Surgery']","['incremental cost-effectiveness ratio', 'cost of using VivaSight-DL']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0039986', 'cui_str': 'Thoracic Surgery'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.0548904,"RESULTS


Fiberoptic confirmation of tube placement was only necessary in two (6.66%) procedures using VivaSight-DL.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Larsen', 'Affiliation': 'Aalborg University, Niels Jernes Vej 10, 9220, Aalborg, Denmark. larsenbk@hotmail.com.'}, {'ForeName': 'Jimmy Højberg', 'Initials': 'JH', 'LastName': 'Holm', 'Affiliation': 'Odense University Hospital, J.B. Winsløws Vej 4, 5000, Odense, Denmark.'}, {'ForeName': 'Tove Nørgaard', 'Initials': 'TN', 'LastName': 'Sauer', 'Affiliation': 'Odense University Hospital, J.B. Winsløws Vej 4, 5000, Odense, Denmark.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Andersen', 'Affiliation': 'Odense University Hospital, J.B. Winsløws Vej 4, 5000, Odense, Denmark.'}]",PharmacoEconomics - open,['10.1007/s41669-019-0163-y']
2696,30831101,"Intrauterine mepivacaine instillation for pain relief during intrauterine device insertion in nulliparous women: a double-blind, randomized, controlled trial.","OBJECTIVE


To evaluate whether intrauterine mepivacaine instillation before intrauterine device (IUD) insertion decreases pain compared to placebo.
STUDY DESIGN


We performed a double-blind, randomized, controlled trial comparing mepivacaine 1% 10 mL versus 0.9% NaCl intrauterine instillation using a hydrosonography catheter 5 min before IUD insertion in women 18 years of age or older. Participants completed a series of 10-cm visual analogue scales (VAS) to report pain during the procedure. The primary outcome was the difference in VAS scores with IUD insertion between intervention group and placebo. Secondary outcomes included VAS before and after insertion and analgesia method acceptability.
RESULTS


We randomized 86 women in a 1:1 ratio; both groups had similar baseline characteristics. In the intention-to-treat analysis, the primary outcome, median VAS with IUD insertion, was 4.8 cm in the intervention group [n=41, interquartile range (IQR) =3.1-5.8] and 5.9 cm in the placebo group (n=40, IQR=3.3-7.5, p=.062). In the per-protocol analysis, the median VAS with IUD insertion was 4.8 cm (IQR=3.1-5.5) and 6.0 cm (IQR=3.4-7.6) for the intervention and placebo groups, respectively (p=.033). More women in the intervention group reported the procedure as easier than expected (n=26, 63.4% vs. n=15, 37.5%), and fewer reported it as worse than expected (n=3, 7.3% vs. n=14, 35%, p=.006).
CONCLUSION


Intrauterine mepivacaine instillation before IUD insertion modestly reduces pain, but the effect size may be clinically significant.
IMPLICATIONS STATEMENT


While the reduction in VAS pain scores did not meet our a priori difference of 1.3 points for clinical significance, participants' favorable subjective reaction suggests that this approach merits further study.",2019,"More women in the intervention group reported the procedure as easier than expected (n=26, 63.4% vs. n=15, 37.5%), and fewer reported it as worse than expected (n=3, 7.3% vs. n=14, 35%, p=.006).
","['86 women in a 1:1 ratio; both groups had similar baseline characteristics', 'nulliparous women', 'women 18\u202fyears of age or older']","['hydrosonography catheter 5\u202fmin before IUD insertion', 'placebo', 'mepivacaine', 'NaCl intrauterine instillation', 'intrauterine mepivacaine instillation before intrauterine device (IUD) insertion', 'Intrauterine mepivacaine instillation', 'Intrauterine mepivacaine']","['pain', 'VAS pain scores', '10-cm visual analogue scales (VAS) to report pain', 'VAS scores with IUD insertion', 'VAS before and after insertion and analgesia method acceptability', 'median VAS with IUD insertion', 'pain relief']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025384', 'cui_str': 'Mepivacaine'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine (qualifier value)'}, {'cui': 'C0184959', 'cui_str': 'Instillation - action (qualifier value)'}, {'cui': 'C0021900', 'cui_str': 'Contraceptive Devices, Intrauterine'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",86.0,0.835558,"More women in the intervention group reported the procedure as easier than expected (n=26, 63.4% vs. n=15, 37.5%), and fewer reported it as worse than expected (n=3, 7.3% vs. n=14, 35%, p=.006).
","[{'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Envall', 'Affiliation': ""The Swedish Association for Sexuality Education-RFSU, Box 4331, SE-102 67 Stockholm, Sweden; Karolinska Institutet, Department of Women's and Children's Health, Division of Obstetrics and Gynaecology, WHO-Centre QB:84. Karolinska University Hospital, Karolinska Vägen 37A, SE-17176 Stockholm, Sweden. Electronic address: niklas.envall@ki.se.""}, {'ForeName': 'Helena Graflund', 'Initials': 'HG', 'LastName': 'Lagercrantz', 'Affiliation': 'Danderyd Hospital, Department of Obstetrics and Gynaecology, Mörbygårdsvägen 88, SE-182 88 Danderyd, Sweden. Electronic address: helena.g.lagercrantz@gmail.com.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Sunesson', 'Affiliation': ""Stockholm Schools' Youth Clinic, Observatoriegatan 20, SE-113 29 Stockholm, Sweden. Electronic address: jessica.sunesson@stockholm.se.""}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Kopp Kallner', 'Affiliation': ""Karolinska Institutet, Department of Women's and Children's Health, Division of Obstetrics and Gynaecology, WHO-Centre QB:84. Karolinska University Hospital, Karolinska Vägen 37A, SE-17176 Stockholm, Sweden; Danderyd Hospital, Department of Obstetrics and Gynaecology, Mörbygårdsvägen 88, SE-182 88 Danderyd, Sweden. Electronic address: helena.kopp-kallner@ki.se.""}]",Contraception,['10.1016/j.contraception.2019.02.003']
2697,31389909,Effects of Exercise Training and Statin Use in People Living with HIV with Dyslipidemia.,"PURPOSE


To evaluate the effects of the combination of ET and statins in people living with HIV.
METHODS


This was a randomized, double-blind, placebo-controlled clinical trial. Eighty-three people living with HIV were assigned to either placebo (PL), statins (STA), placebo + ET (PLET) or statins + ET (STAET) groups. Volunteers assigned to STA and STAET groups were administered 10 mg of rosuvastatin, whereas the PL and PLET groups were administered a placebo. PLET and STAET groups performed ET three times a week. Before and after the 12-week follow-up, the volunteers underwent to anthropometric assessment and blood collection to evaluate lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests were performed.
RESULTS


There was a decrease in total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-c), C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness (cIMT) in the STA, PLET, and STAET groups compared to PL group (p<0.001). Furthermore, there was a decrease in TC, TG, LDL, IL-1β, IL-6, and IL-8 levels and in left and right cIMT and an increase in HDL-c levels in the STAET groups compared to the STA (p<0.001) and PLET groups (p<0.001). There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001). The PLET and STAET groups reduced body fat mass, body fat percentage and increased lean body mass, MS and CF compared to PL (p<0.001) and STA (p<0.001) groups.
CONCLUSION


The combination of ET and statins is useful to enhance lipid and inflammatory profiles, reduce CVD markers, and improve Doppler ultrasound findings, MS and CF in people living with HIV.",2019,"There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001).","['people living with HIV', 'People Living with HIV with Dyslipidemia', 'Eighty-three people living with HIV']","['STA', 'placebo (PL), statins (STA), placebo + ET (PLET) or statins + ET (STAET', 'rosuvastatin', 'Exercise Training and Statin Use', 'placebo', 'PLET', 'ET and statins']","['TC, TG, LDL, IL-1β, IL-6, and IL-8 levels and in left and right cIMT and an increase in HDL-c levels', 'lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests', 'IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate', 'body fat mass, body fat percentage and increased lean body mass, MS and CF', 'total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-c), C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness (cIMT']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C4517888', 'cui_str': '83'}]","[{'cui': 'C1529286', 'cui_str': 'stas'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}]",83.0,0.0940275,"There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001).","[{'ForeName': 'Hugo Ribeiro', 'Initials': 'HR', 'LastName': 'Zanetti', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Gonçalves', 'Affiliation': 'Master Institute of Education President Antônio Carlos, Araguari/MG, Brazil.'}, {'ForeName': 'Leandro Teixeira', 'Initials': 'LT', 'LastName': 'Paranhos Lopes', 'Affiliation': 'Brazil University, Fernandópolis/SP, Brazil.'}, {'ForeName': 'Edmar Lacerda', 'Initials': 'EL', 'LastName': 'Mendes', 'Affiliation': 'Institute of Health Sciences, Department of Sport Sciences, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Roever', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}, {'ForeName': 'Mário Leon', 'Initials': 'ML', 'LastName': 'Silva-Vergara', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Fernando Freitas', 'Initials': 'FF', 'LastName': 'Neves', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Elmiro Santos', 'Initials': 'ES', 'LastName': 'Resende', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002120']
2698,31789301,Effect of simultaneous proprioceptive-visual feedback on gait of children with spastic diplegic cerebral palsy.,"OBJECTIVE


To evaluate the effect of simultaneous proprioceptive - visual training on gait parameters in children with spastic diplegic cerebral palsy.
METHOD


Gait parameters of 30 spastic diplegic children (age range 4-6 years) were evaluated before and after treatment by Tekscan's Walkway Pressure system. They were randomly and equally assigned into two groups (study and control). All children received regular therapeutic exercise program for one hour. In control group walked for 30 minutes without feedback, while those in study group walked for 30 minutes with proprioceptive-visual feedback. Duration of treatment was 3 times/week for 8 successive weeks.
RESULTS


There were significant differences after treatment in spatial parameters and temporal parameters of both groups with more improvement in study group than control one, and insignificant difference in kinetic gait parameters.
CONCLUSION


The simultaneous proprioceptive - visual training might improve spatial and temporal gait parameters with no effect on kinetic gait parameters of children with spastic diplegic cerebral palsy.",2019,"There were significant differences after treatment in spatial parameters and temporal parameters of both groups with more improvement in study group than control one, and insignificant difference in kinetic gait parameters.
","['children with spastic diplegic cerebral palsy', 'Gait parameters of 30 spastic diplegic children (age range 4-6 years']","['simultaneous proprioceptive-visual feedback', 'simultaneous proprioceptive - visual training', 'regular therapeutic exercise program']","['kinetic gait parameters', 'gait parameters', 'spatial parameters and temporal parameters']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0270804', 'cui_str': 'Cerebral palsy, spastic, diplegic'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0443306', 'cui_str': 'Spastic'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0200244', 'cui_str': 'Visual training'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}]",,0.0132695,"There were significant differences after treatment in spatial parameters and temporal parameters of both groups with more improvement in study group than control one, and insignificant difference in kinetic gait parameters.
","[{'ForeName': 'Zeinab A', 'Initials': 'ZA', 'LastName': 'Hussein', 'Affiliation': 'Department of Physical Therapy For pediatrics, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ibrahim A', 'Initials': 'IA', 'LastName': 'Salem', 'Affiliation': 'Department of Physical Therapy For pediatrics, Faculty of Physical Therapy, modern University for technology and information, Cairo, Egypt.'}, {'ForeName': 'Mostafa S', 'Initials': 'MS', 'LastName': 'Ali', 'Affiliation': 'Department of Physical Therapy For pediatrics, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}]",Journal of musculoskeletal & neuronal interactions,[]
2699,32086878,Changes in kidney function among men having sex with men starting on demand tenofovir disoproxil fumarate - emtricitabine for HIV pre-exposure prophylaxis.,"INTRODUCTION


Daily pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is associated with a small but statistically significant decrease in estimated glomerular filtration rate (eGFR). We assessed the renal safety of on-demand PrEP with TDF/FTC in HIV-1 uninfected men.
METHODS


We used data from the randomized double-blind placebo-controlled ANRS-IPERGAY trial and its open-label extension conducted between February 2012 and June 2016 among HIV-uninfected MSM starting on-demand PrEP. Using linear mixed model, we evaluated the mean eGFR decline from baseline over time and determined risks factors associated with eGFR decline during the study.
RESULTS


During the blind phase, with a median follow-up of 9.4 months, the mean decline slope of eGFR from baseline was -0.88 and -1.53 mL/min/1.73 m 2  per year in the placebo (n = 201) and the TDF/FTC group (n = 198) respectively, with a slope difference of 0.65 mL/min/1.73 m 2  per year (p = 0.27). Including both phases, 389 participants started on-demand TDF/FTC with a median follow-up of 19.2 months and a mean decline of eGFR from baseline of -1.14 mL/min/1.73 m 2  per year (p < 0.001). The slope of eGFR reduction was not significantly different in participants with baseline eGFR ≤ 90 mL/min/1.73 m 2  (p = 0.44), age >40 years (p = 0.24) or hypertension (p = 0.21). There was a dose-response relationship between recent tenofovir exposure and lower eGFR when considering the number of pills taken in the two months prior the visit (eGFR difference of -0.88 mL/min/1.73 m 2  between >15 pills/month vs. ≤15 pills/month, p < 0.01) or plasma tenofovir concentrations at the visit (eGFR difference compared to ≤2 ng/mL: >2 to ≤10ng/mL: -0.98 mL/min/1.73 m 2  , >10 to ≤40ng/mL: -1.28 mL/min/1.73 m 2  , >40 ng/mL: -1.82 mL/min/1.73 m 2  , p < 0.001). Three participants discontinued TDF/FTC for eGFR < 60 mL/min/1.73 m 2  during the OLE phase. No case of Fanconi syndrome was reported.
CONCLUSIONS


The renal safety of on-demand PrEP with TDF/FTC was good. The overall reduction and intermittent exposure to TDF/FTC may explain this good renal safety.",2020,The slope of eGFR reduction was not significantly different in participants with baseline eGFR ≤ 90 mL,"['group (n\xa0=\xa0198', 'February 2012 and June 2016 among HIV-uninfected MSM starting on-demand PrEP', 'men having sex with men starting on demand', '40', 'HIV-1 uninfected men']","['tenofovir disoproxil fumarate - emtricitabine', 'tenofovir disoproxil fumarate/emtricitabine (TDF/FTC', 'placebo', 'mL', 'Daily pre-exposure prophylaxis (PrEP', 'ng/mL', 'TDF/FTC']","['mean eGFR decline', 'kidney function', 'renal safety', 'Fanconi syndrome', 'slope of eGFR reduction', 'estimated glomerular filtration rate (eGFR', 'plasma tenofovir concentrations']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015624', 'cui_str': 'Proximal Renal Tubular Dysfunction'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C3811844'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.29567,The slope of eGFR reduction was not significantly different in participants with baseline eGFR ≤ 90 mL,"[{'ForeName': 'Geoffroy', 'Initials': 'G', 'LastName': 'Liegeon', 'Affiliation': 'Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Guillemette', 'Initials': 'G', 'LastName': 'Antoni', 'Affiliation': 'INSERM, Villejuif, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Pialoux', 'Affiliation': 'Hôpital Tenon, Paris, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Capitant', 'Affiliation': 'INSERM, Villejuif, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Cotte', 'Affiliation': 'Hôpital de la Croix Rousse, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Charreau', 'Affiliation': 'INSERM, Villejuif, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Tremblay', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Montréal, Canada.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Cua', 'Affiliation': ""Hôpital de l'Archet, Nice, France.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Senneville', 'Affiliation': 'Hôpital G. Dron, Centre Hospitalier Universitaire de Tourcoing, Tourcoing, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Raffi', 'Affiliation': 'INSERM UIC 143 Nantes University, Nantes, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Meyer', 'Affiliation': 'INSERM, Villejuif, France.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the International AIDS Society,['10.1002/jia2.25420']
2700,31397587,Impact of exposure to counterstereotypic causality of obesity on beliefs about weight controllability and obesity bias.,"Individuals with obesity often report experiencing prejudice and discrimination due to their weight. Past research on obesity bias reduction strategies have yielded mixed results. The present study investigated the effectiveness of manipulating information about weight controllability in reducing obesity bias. Participants ( N  = 350) were randomly assigned into one of three conditions: counterstereotypic, stereotypic, or control. Each condition consisted of four short vignettes. The counterstereotypic condition provided an uncontrollable explanation of obesity (e.g., genetics) in each vignette describing a person with obesity, while the stereotypic condition emphasized lifestyle choices as the main cause of obesity. The control condition included a vignette in which weight was not addressed. Participants completed questionnaires about weight controllability and obesity bias pre- and post-exposure. There was a significant interaction between time and condition on beliefs about weight controllability and obesity bias. Participants in the counterstereotypic condition increased in belief about the uncontrollability of weight and decreased in obesity bias, while participants in the stereotypic condition decreased in belief about the uncontrollability of weight and increased in obesity bias. Obesity bias reduction strategies that utilize information about weight controllability can be effective. However, perpetuating stereotypic causes of obesity can worsen the problem.",2020,"Participants in the counterstereotypic condition increased in belief about the uncontrollability of weight and decreased in obesity bias, while participants in the stereotypic condition decreased in belief about the uncontrollability of weight and increased in obesity bias.","['Participants ( N  =\xa0350', 'Individuals with obesity often report experiencing prejudice and discrimination due to their weight']","['counterstereotypic, stereotypic, or control']","['belief about the uncontrollability of weight', 'uncontrollability of weight', 'obesity bias']","[{'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0033023', 'cui_str': 'Prejudice'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005346', 'cui_str': 'Bias'}]",,0.0206787,"Participants in the counterstereotypic condition increased in belief about the uncontrollability of weight and decreased in obesity bias, while participants in the stereotypic condition decreased in belief about the uncontrollability of weight and increased in obesity bias.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Health and Human Values Department, Davidson College , Davidson, NC, USA.'}, {'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Stutts', 'Affiliation': 'Health and Human Values Department, Davidson College , Davidson, NC, USA.'}]","Psychology, health & medicine",['10.1080/13548506.2019.1653484']
2701,31773208,Dose-dependent effects of estrogen on prediction error related neural activity in the nucleus accumbens of healthy young women.,"RATIONALE


Whereas the effect of the sex steroid 17-beta-estradiol (E2) on dopaminergic (DA) transmission in the nucleus accumbens (NAc) is well evidenced in female rats, studies in humans are inconsistent. Moreover, linear and inverted u-shaped dose response curves have been observed for E2's effects on hippocampal plasticity, but the shape of dose response curves for E2's effects on the NAc is much less characterized.
OBJECTIVES


Investigation of dose response curves for E2's effects on DA-related neural activity in the human NAc.
METHODS


Placebo or E2 valerate in doses of 2, 4, 6 or 12 mg was orally administered to 125 naturally cycling young women during the low-hormone menstruation phase on two consecutive days using a randomized, double-blinded design. The E2 treatment regimen induced a wide range of E2 levels, from physiological (2- and 4-mg groups; equivalent to cycle peak) to supraphysiological levels (6- and 12-mg groups; equivalent to early pregnancy). This made it possible to study different dose response functions for E2's effects on NAc activity. During E2 peak, participants performed a well-established reversal learning paradigm. We used trial-wise prediction errors (PE) estimated via a computational reinforcement learning model as a proxy for dopaminergic activity. Linear and quadratic regression analyses predicting PE-related NAc activity from salivary E2 levels were calculated.
RESULTS


There was a positive linear relationship between PE-associated NAc activity and salivary E2 increases.
CONCLUSIONS


The randomized, placebo-controlled elevation of E2 levels stimulates NAc activity in the human brain, likely mediated by dopaminergic processes.",2020,"Moreover, linear and inverted u-shaped dose response curves have been observed for E2's effects on hippocampal plasticity, but the shape of dose response curves for E2's effects on the NAc is much less characterized.
","['female rats', 'healthy young women', '125 naturally cycling young women during the low-hormone menstruation phase on two consecutive days']","['placebo', 'sex steroid 17-beta-estradiol (E2', 'estrogen', 'Placebo or E2 valerate']","['NAc activity and salivary E2 increases', 'wide range of E2 levels']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C3503281', 'cui_str': 'valerate'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",125.0,0.185804,"Moreover, linear and inverted u-shaped dose response curves have been observed for E2's effects on hippocampal plasticity, but the shape of dose response curves for E2's effects on the NAc is much less characterized.
","[{'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Bayer', 'Affiliation': 'Department of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany. j.bayer@uke.de.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Rusch', 'Affiliation': 'Department of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gläscher', 'Affiliation': 'Department of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Sommer', 'Affiliation': 'Department of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany.'}]",Psychopharmacology,['10.1007/s00213-019-05409-7']
2702,32112556,Integrated management of atrial fibrillation in primary care: results of the ALL-IN cluster randomized trial.,"AIMS


To evaluate whether integrated care for atrial fibrillation (AF) can be safely orchestrated in primary care.
METHODS AND RESULTS


The ALL-IN trial was a cluster randomized, open-label, pragmatic non-inferiority trial performed in primary care practices in the Netherlands. We randomized 26 practices: 15 to the integrated care intervention and 11 to usual care. The integrated care intervention consisted of (i) quarterly AF check-ups by trained nurses in primary care, also focusing on possibly interfering comorbidities, (ii) monitoring of anticoagulation therapy in primary care, and finally (iii) easy-access availability of consultations from cardiologists and anticoagulation clinics. The primary endpoint was all-cause mortality during 2 years of follow-up. In the intervention arm, 527 out of 941 eligible AF patients aged ≥65 years provided informed consent to undergo the intervention. These 527 patients were compared with 713 AF patients in the control arm receiving usual care. Median age was 77 (interquartile range 72-83) years. The all-cause mortality rate was 3.5 per 100 patient-years in the intervention arm vs. 6.7 per 100 patient-years in the control arm [adjusted hazard ratio (HR) 0.55; 95% confidence interval (CI) 0.37-0.82]. For non-cardiovascular mortality, the adjusted HR was 0.47 (95% CI 0.27-0.82). For other adverse events, no statistically significant differences were observed.
CONCLUSION


In this cluster randomized trial, integrated care for elderly AF patients in primary care showed a 45% reduction in all-cause mortality when compared with usual care.",2020,"For other adverse events, no statistically significant differences were observed.
","['elderly AF patients in primary care', 'primary care', '527 patients were compared with 713 AF patients in the control arm receiving usual care', 'Median age was 77 (interquartile range 72-83) years', '527 out of 941 eligible AF patients aged ≥65 years']","['integrated care for atrial fibrillation (AF', 'integrated care intervention and 11 to usual care', 'integrated care intervention consisted of (i) quarterly AF check-ups by trained nurses in primary care, also focusing on possibly interfering comorbidities, (ii) monitoring of anticoagulation therapy in primary care, and finally (iii) easy-access availability of consultations from cardiologists and anticoagulation clinics']","['cause mortality', 'mortality rate']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4517805', 'cui_str': 'Five hundred and twenty-seven'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0332179', 'cui_str': 'q3mo'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C2362652', 'cui_str': 'Possible diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332219', 'cui_str': 'Easy (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0175906', 'cui_str': 'Cardiologists'}, {'cui': 'C3839946', 'cui_str': 'Anticoagulation clinic'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",26.0,0.0804642,"For other adverse events, no statistically significant differences were observed.
","[{'ForeName': 'Carline J', 'Initials': 'CJ', 'LastName': 'van den Dries', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht/Utrecht University, Str. 6.131, PO Box 85500, 3508 GA Utrecht, the Netherlands.'}, {'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'van Doorn', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht/Utrecht University, Str. 6.131, PO Box 85500, 3508 GA Utrecht, the Netherlands.'}, {'ForeName': 'Frans H', 'Initials': 'FH', 'LastName': 'Rutten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht/Utrecht University, Str. 6.131, PO Box 85500, 3508 GA Utrecht, the Netherlands.'}, {'ForeName': 'Ruud', 'Initials': 'R', 'LastName': 'Oudega', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht/Utrecht University, Str. 6.131, PO Box 85500, 3508 GA Utrecht, the Netherlands.'}, {'ForeName': 'Sjef J C M', 'Initials': 'SJCM', 'LastName': 'van de Leur', 'Affiliation': 'Thrombosis Service, Isala Hospital Zwolle, Postbus 10400, 8000 GK Zwolle, the Netherlands.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Elvan', 'Affiliation': 'Department of Cardiology, Isala Hospital Zwolle, Postbus 10400, 8000 GK Zwolle, the Netherlands.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Oude Grave', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht/Utrecht University, Str. 6.131, PO Box 85500, 3508 GA Utrecht, the Netherlands.'}, {'ForeName': 'Henk J G', 'Initials': 'HJG', 'LastName': 'Bilo', 'Affiliation': 'Department of Internal Medicine, Isala Hospital Zwolle, Postbus 10400, 8000 GK Zwolle, the Netherlands.'}, {'ForeName': 'Karel G M', 'Initials': 'KGM', 'LastName': 'Moons', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht/Utrecht University, Str. 6.131, PO Box 85500, 3508 GA Utrecht, the Netherlands.'}, {'ForeName': 'Arno W', 'Initials': 'AW', 'LastName': 'Hoes', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht/Utrecht University, Str. 6.131, PO Box 85500, 3508 GA Utrecht, the Netherlands.'}, {'ForeName': 'Geert-Jan', 'Initials': 'GJ', 'LastName': 'Geersing', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht/Utrecht University, Str. 6.131, PO Box 85500, 3508 GA Utrecht, the Netherlands.'}]",European heart journal,['10.1093/eurheartj/ehaa055']
2703,32100358,Effect of Drinking Oxygenated Water Assessed by in vivo MRI Relaxometry.,"GRANT SUPPORT


This project was funded by the Research Council of Norway.
BACKGROUND


Oxygen uptake through the gastrointestinal tract after oral administration of oxygenated water in humans is not well studied and is debated in the literature. Due to the paramagnetic properties of oxygen and deoxyhemoglobin, MRI as a technique might be able to detect changes in relaxometry values caused by increased oxygen levels in the blood.
PURPOSE


To assess whether oxygen dissolved in water is absorbed from the gastrointestinal tract and transported into the bloodstream after oral administration.
STUDY TYPE


A randomized, double-blinded, placebo-controlled crossover trial.
POPULATION/SUBJECTS


Thirty healthy male volunteers age 20-35.
FIELD STRENGTH/SEQUENCE


3T/Modified Look-Locker inversion recovery (MOLLI) T 1  -mapping and multi fast field echo (mFFE) T 2  *-mapping.
ASSESSMENT


Each volunteer was scanned in two separate sessions. T 1  and T 2  * maps were acquired repeatedly covering the hepatic portal vein (HPV) and vena cava inferior (VCI, control vein) before and after intake of oxygenated or control water. Assessments were done by placing a region of interest in the HPV and VCI.
STATISTICAL TEST


A mixed linear model was performed to the compare control vs. oxygen group.
RESULTS


Drinking caused a mean 1.6% 95% CI (1.1-2.0% P < 0.001) increase in T 1  of HPV blood and water oxygenation attributed another 0.70% 95% confidence interval (CI) (0.07-1.3% P = 0.028) increase. Oxygenation did not change T 1  in VCI blood. Mean T 2  * increased 9.6% 95% CI (1.7-17.5% P = 0.017) after ingestion of oxygenated water and 1.2% 95% CI (-4.3-6.8% P = 0.661) after ingestion of control water. The corresponding changes in VCI blood were not significant.
DATA CONCLUSION


Ingestion of water caused changes in T 1  and T 2  * of HPV blood compatible with dilution due to water absorption. The effects were enhanced by oxygen. Assessment of oxygen enrichment of HPV blood was not possible due to the dilution effect.
LEVEL OF EVIDENCE


2 TECHNICAL EFFICACY STAGE: 2 J. Magn. Reson. Imaging 2020;52:720-728.",2020,Mean T 2  * increased 9.6% 95% CI (1.7-17.5% P = 0.017) after ingestion of oxygenated water and 1.2% 95% CI (-4.3-6.8% P = 0.661) after ingestion of control water.,['Thirty healthy male volunteers age 20-35'],['placebo'],"['hepatic portal vein (HPV) and vena cava inferior (VCI, control vein', 'VCI blood', 'Drinking Oxygenated Water Assessed by in vivo MRI Relaxometry', 'HPV blood and water oxygenation']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032718', 'cui_str': 'Portal Vein'}, {'cui': 'C0042460', 'cui_str': 'Venae Cavae'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0042449', 'cui_str': 'Veins'}, {'cui': 'C0005768'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]",30.0,0.11569,Mean T 2  * increased 9.6% 95% CI (1.7-17.5% P = 0.017) after ingestion of oxygenated water and 1.2% 95% CI (-4.3-6.8% P = 0.661) after ingestion of control water.,"[{'ForeName': 'Svein Are Sirirud', 'Initials': 'SAS', 'LastName': 'Vatnehol', 'Affiliation': 'Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Per Kristian', 'Initials': 'PK', 'LastName': 'Hol', 'Affiliation': 'Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Atle', 'Initials': 'A', 'LastName': 'Bjørnerud', 'Affiliation': 'Department of Physics, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Amiry-Moghaddam', 'Affiliation': 'Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Haglerød', 'Affiliation': 'Oxy Solutions AS, Oslo, Norway.'}, {'ForeName': 'Tryggve Holck', 'Initials': 'TH', 'LastName': 'Storås', 'Affiliation': 'Department of Diagnostic Physics, Oslo University Hospital, Oslo, Norway.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.27104']
2704,32112181,Effect of amlodipine on blood flow of preovulatory follicle in women with clomiphene resistant polycystic ovaries: a randomized controlled trial.,"OBJECTIVE


To detect whether amlodipine could increase pre-ovulatory follicular blood flow, thus enhancing ovulation and creating a better chance of conception in women with PCOS.
METHODS


165 women were screened of which 124 were qualified and women were equally randomized to 62 receiving clomiphene citrate and amlodipine and 62 receiving clomiphene citrate and placebo. The primary outcome was to detect if amlodipine can improve pre-ovulatory follicle blood flow studied by colour and power Doppler Pulsatility index of ovarian arteries, with drug administration. The secondary outcomes were endometrial thickness and clinical pregnancy.
RESULTS


The mean value of the ovarian arteries Pulsatility Index was significantly lower in the amlodipine group when compared to those of the placebo group (1.36 and 1.82, respectively, with P value 0.002). Mean endometrial thickness, for all women in both groups, on the day of detecting a mature follicle was significantly higher in the amlodipine group compared to the placebo group (8.99 and 7.0, respectively, with P value 0.003), and clinical pregnancy increased from 11% to 37% in the amlodipine group compared to the placebo group.
CONCLUSION


Amlodipine improves ovarian blood flow and increases the chances of conception.
TRIAL REGISTRATION


Pan African Clinical Trial Registry (http://www.pactr.org). Trial No: PAC TR201708002485292.",2020,"The mean value of the ovarian arteries Pulsatility Index was significantly lower in the amlodipine group when compared to those of the placebo group (1.36 and 1.82, respectively, with P value 0.002).","['165 women were screened of which 124 were qualified and women', 'women with PCOS', 'women with clomiphene resistant polycystic ovaries']","['clomiphene citrate and placebo', 'clomiphene citrate and amlodipine', 'placebo', 'Amlodipine', 'amlodipine']","['endometrial thickness and clinical pregnancy', 'pre-ovulatory follicle blood flow studied by colour and power Doppler Pulsatility index of ovarian arteries, with drug administration', 'mean value of the ovarian arteries Pulsatility Index', 'clinical pregnancy', 'ovarian blood flow', 'Mean endometrial thickness', 'blood flow of preovulatory follicle', 'pre-ovulatory follicular blood flow', 'chances of conception']","[{'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0009008', 'cui_str': 'Clomiphene'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}]","[{'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory (finding)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0226411', 'cui_str': 'Structure of ovarian artery'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439682', 'cui_str': 'Follicular (qualifier value)'}, {'cui': 'C0009637', 'cui_str': 'Conception'}]",165.0,0.3901,"The mean value of the ovarian arteries Pulsatility Index was significantly lower in the amlodipine group when compared to those of the placebo group (1.36 and 1.82, respectively, with P value 0.002).","[{'ForeName': 'Haitham A', 'Initials': 'HA', 'LastName': 'Torky', 'Affiliation': 'Obstetrics and Gynecology Department, October 6th University and Air-Force Specialized Hospital, New Cairo, Egypt. haithamtorky@yahoo.com.'}, {'ForeName': 'Atef', 'Initials': 'A', 'LastName': 'Shata', 'Affiliation': 'Obstetrics and Gynecology Department, Matariya Teaching Hospital and Air-Force Specialized Hospital, New Cairo, Egypt.'}, {'ForeName': 'Ali M', 'Initials': 'AM', 'LastName': 'Ahmad', 'Affiliation': 'Obstetrics and Gynecology Department, Al-Galaa Teaching Hospital and Air-Force Specialized Hospital, New Cairo, Egypt.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Ragab', 'Affiliation': 'Obstetrics and Gynecology Department, Al-Galaa Teaching Hospital and Air-Force Specialized Hospital, New Cairo, Egypt.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Abo-Louz', 'Affiliation': 'Obstetrics and Gynecology Department, October 6th University and Air-Force Specialized Hospital, New Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hussein', 'Affiliation': 'Obstetrics and Gynecology Department, October 6th University and Air-Force Specialized Hospital, New Cairo, Egypt.'}, {'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Aly', 'Affiliation': 'Obstetrics and Gynecology Department, Al-Galaa Teaching Hospital and Air-Force Specialized Hospital, New Cairo, Egypt.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05471-z']
2705,31377215,The Role of Heart Rate Variability in Mindfulness-Based Pain Relief.,"Mindfulness meditation is a self-regulatory practice premised on sustaining nonreactive awareness of arising sensory events that reliably reduces pain. Yet, the specific analgesic mechanisms supporting mindfulness have not been comprehensively disentangled from the potential nonspecific factors supporting this technique. Increased parasympathetic nervous system (PNS) activity is associated with pain relief corresponding to a number of cognitive manipulations. However, the relationship between the PNS and mindfulness-based pain attenuation remains unknown. The primary objective of the present study was to determine the role of high-frequency heart rate variability (HF HRV), a marker of PNS activity, during mindfulness-based pain relief as compared to a validated, sham-mindfulness meditation technique that served as a breathing-based control. Sixty-two healthy volunteers (31 females; 31 males) were randomized to a 4-session (25 min/session) mindfulness or sham-mindfulness training regimen. Before and after each group's respective training, participants were administered noxious (49°C) and innocuous (35°C) heat to the right calf. HF HRV and respiration rate were recorded during thermal stimulation and pain intensity and unpleasantness ratings were collected after each stimulation series. The primary analysis revealed that during mindfulness meditation, higher HF HRV was more strongly associated with lower pain unpleasantness ratings when compared to sham-mindfulness meditation (B = -.82, P = .04). This finding is in line with the prediction that mindfulness-based meditation engages distinct mechanisms from sham-mindfulness meditation to reduce pain. However, the same prediction was not confirmed for pain intensity ratings (B = -.41). Secondary analyses determined that mindfulness and sham-mindfulness meditation similarly reduced pain ratings, decreased respiration rate, and increased HF HRV (between group ps < .05). More mechanistic work is needed to reliably determine the role of parasympathetic activation in mindfulness-based pain relief as compared to other meditative techniques. Perspective: Mindfulness has been shown to engage multiple mechanisms to reduce pain. The present study extends on this work to show that higher HRV is associated with mindfulness-induced reductions in pain unpleasantness, but not pain intensity ratings, when compared to sham-mindfulness meditation. These findings warrant further investigation into the mechanisms engaged by mindfulness as compared to placebo.",2020,"The primary analysis revealed that during mindfulness meditation, higher HF HRV was more strongly associated with lower pain unpleasantness ratings when compared to sham-mindfulness meditation (B = -0.82, p = 0.04).",['Sixty-two healthy volunteers (31 females; 31 males'],"['placebo', 'session) mindfulness or sham-mindfulness training regimen', 'Mindfulness meditation']","['pain unpleasantness ratings', 'Increased parasympathetic nervous system (PNS) activity', 'pain', 'pain ratings, decreased respiration rate, and increased HF HRV', 'HF HRV', 'pain unpleasantness', 'pain intensity and unpleasantness ratings', 'pain intensity ratings', 'HF HRV and respiration rate']","[{'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0150277'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0030510', 'cui_str': 'Parasympathetic Nervous System'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}]",62.0,0.0356322,"The primary analysis revealed that during mindfulness meditation, higher HF HRV was more strongly associated with lower pain unpleasantness ratings when compared to sham-mindfulness meditation (B = -0.82, p = 0.04).","[{'ForeName': 'Adrienne L', 'Initials': 'AL', 'LastName': 'Adler-Neal', 'Affiliation': 'Department of Neurobiology and Anatomy, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Christian E', 'Initials': 'CE', 'LastName': 'Waugh', 'Affiliation': 'Department of Psychology, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Garland', 'Affiliation': 'College of Social Work & Center on Mindfulness and Integrative Health Intervention Development, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Hossam A', 'Initials': 'HA', 'LastName': 'Shaltout', 'Affiliation': 'Department of Surgery/Hypertension and Vascular Research, Cardiovascular Sciences Center, Winston-Salem, North Carolina; Department of Obstetrics and Gynecology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Debra I', 'Initials': 'DI', 'LastName': 'Diz', 'Affiliation': 'Department of Surgery/Hypertension and Vascular Research, Cardiovascular Sciences Center, Winston-Salem, North Carolina.'}, {'ForeName': 'Fadel', 'Initials': 'F', 'LastName': 'Zeidan', 'Affiliation': 'Department of Neurobiology and Anatomy, Wake Forest School of Medicine, Winston-Salem, North Carolina; Department of Anesthesiology, University of California San Diego, San Diego, California. Electronic address: fzeidan@ucsd.edu.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.07.003']
2706,32088423,Does earlier splint removal truly affect functional recovery and kinesiophobia after tendon repair?,"Splinting how the hand can be used in daily life. Therefore, earlier splint removal is thought to improve functional recovery. The aim of our study was to assess the outcomes of patients who removed their splint and started using their hand earlier and compare them to patients who received routine care. Patients with tendon repairs were divided into two groups: Group 1 (Early) started daily use of their hand at the 5th postoperative week and Group 2 (Later) at the 6th week. Patients received regular therapy consisting of an early motion protocol. Assessments were performed at three consecutive time points. Grip and pinch strength was measured and Nine-Hole Peg Test (9HPT) was performed. Disabilities of the Arm, Shoulder and Hand (DASH) and Tampa Scale for Kinesiophobia (TSK) were filled out. Both within-group and between-group analyses were performed. A total of 58 patients with flexor or extensor tendon repairs were analyzed. All parameters improved significantly over time within both groups (P<0.05). When the time effect was ignored, kinesiophobia, disability and functional results - except grip strength - were statistically better in Group 2 group than in Group 1 (P<0.05). Our results showed that, despite the clinically observed recovery, earlier splint removal and start of daily hand use did not truly improve the functional results. To us, this means that the remarkable advances in surgical techniques do not accelerate the physiological healing process. Therefore, clinical recommendations should always be supported with evidence-based data.",2020,All parameters improved significantly over time within both groups (p < 0.05).,"['patients who removed their splint and started using their hand earlier and compare them to patients who received routine care', 'Patients with tendon repairs', '58 patients with flexor or extensor tendon repairs']",['regular therapy consisting of an early motion protocol'],"['Disabilities of the Arm, Shoulder and Hand (DASH) and Tampa Scale for Kinesiophobia', 'kinesiophobia, disability and functional results - except grip strength ', 'Grip and pinch strength']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0562230', 'cui_str': 'Hand functions (observable entity)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0565350', 'cui_str': 'Repair of tendon (procedure)'}, {'cui': 'C0224849', 'cui_str': 'Structure of extensor tendon'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0222045'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}, {'cui': 'C1720876', 'cui_str': 'Pinch Strength'}]",58.0,0.0177842,All parameters improved significantly over time within both groups (p < 0.05).,"[{'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Tuna', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Emniyet Mah. Muammer Yaşar Bostancı Cad. No:16, 06560 Beşevler, Ankara, Turkey. Electronic address: zeyneptuna6@yahoo.com.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Oskay', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Emniyet Mah. Muammer Yaşar Bostancı Cad. No:16, 06560 Beşevler, Ankara, Turkey.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gökkurt', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Emniyet Mah. Muammer Yaşar Bostancı Cad. No:16, 06560 Beşevler, Ankara, Turkey.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Mete', 'Affiliation': 'Yildirim Beyazit University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Kızılca Mahallesi, 06760 Çubuk, Ankara, Turkey.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bağlan Yentür', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Emniyet Mah. Muammer Yaşar Bostancı Cad. No:16, 06560 Beşevler, Ankara, Turkey.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ambarcioğlu', 'Affiliation': 'Ankara University, Faculty of Veterinary Medicine, Department of Biostatistics, Ziraat, Şht. Ömer Halisdemir Blv, 06110 Altındağ, Ankara, Turkey.'}]",Hand surgery & rehabilitation,['10.1016/j.hansur.2020.01.006']
2707,31699671,The Role of CXCL13 and CXCL9 in Early Breast Cancer.,"BACKGROUND


Chemokines, cytokines in the immune microenvironment of tumors, may be associated with patient outcome. We assessed the impact of CXCL13 and CXCL9 on disease-free (DFS) and overall survival (OS), in an attempt to retrospectively evaluate both T and B cell function in the microenvironment of primary tumors from patients with breast cancer.
MATERIALS AND METHODS


Formalin-fixed paraffin-embedded tissue blocks from patients with intermediate/high-risk, early breast cancer, treated with sequential adjuvant epirubicin, paclitaxel, and cyclophosphamide methotrexate fluorouracil within a randomized trial, were tested for CXCL13 and CXCL9 messenger RNA expression; 557 patients with adequate tissue were eligible for the analysis.
RESULTS


CXCL13 was correlated with CXCL9 (rho = 0.52; P < .001). High-expressing CXL13 and CXCL9 tumors had higher Ki67 and tumor infiltrating lymphocyte density (P-values < .001). High CXCL9 expression was an unfavorable prognosticator for OS among all patients (hazard ratio [HR], 1.73; P = .021), whereas it showed favorable significance for both DFS and OS in patients with triple negative disease (HR, 0.29; P = .027 and HR, 0.32; P = .045). High CXCL13 conferred longer DFS and OS among patients with luminal-human epidermal growth factor receptor 2 disease (HR, 0.31; P = .013 and HR, 0.25; P = .005). Patients with low CXCL13 and high CXCL9 expression had shorter DFS and OS compared with those with high expression of both chemokines (HR, 1.63; P = .006 and HR, 1.61; P = .016).
CONCLUSIONS


Both biomarkers were associated with poor prognosis characteristics and with tumor infiltrating lymphocyte density. High CXCL9 conferred an improved prognosis in the triple negative subtype, whereas high CXCL13 was associated with improved outcome in the luminal-human epidermal growth factor receptor 2 subtype. Chemokines can be associated with breast cancer subtype and outcome. These data should be evaluated prospectively.",2020,"Patients with low CXCL13 and high CXCL9 expression had shorter DFS and OS compared with those with high expression of both chemokines (HR, 1.63; P = .006 and HR, 1.61; P = .016).
","['557 patients with adequate tissue were eligible for the analysis', 'Formalin-fixed paraffin-embedded tissue blocks from patients with intermediate/high-risk, early breast cancer, treated with', 'patients with breast cancer', 'Early Breast Cancer']","['sequential adjuvant epirubicin, paclitaxel, and cyclophosphamide methotrexate fluorouracil', 'CXCL13 and CXCL9']","['higher Ki67 and tumor infiltrating lymphocyte density', 'High CXCL9 expression', 'disease-free (DFS) and overall survival (OS', 'DFS and OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0949307', 'cui_str': 'Formalin'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0085185', 'cui_str': 'Paraffin Embedding'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0079722', 'cui_str': 'Lymphocytes, Tumor-Infiltrating'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",557.0,0.0231105,"Patients with low CXCL13 and high CXCL9 expression had shorter DFS and OS compared with those with high expression of both chemokines (HR, 1.63; P = .006 and HR, 1.61; P = .016).
","[{'ForeName': 'Evangelia', 'Initials': 'E', 'LastName': 'Razis', 'Affiliation': 'Third Department of Medical Oncology, Hygeia Hospital, Athens, Greece. Electronic address: e.razis@hygeia.gr.'}, {'ForeName': 'Konstantine T', 'Initials': 'KT', 'LastName': 'Kalogeras', 'Affiliation': 'Translational Research Section, Hellenic Cooperative Oncology Group, Athens, Greece; Laboratory of Molecular Oncology, Hellenic Foundation for Cancer Research/Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Kotsantis', 'Affiliation': 'Section of Medical Oncology, Department of Internal Medicine, Attikon University Hospital, National and Kapodistrian University of Athens School of Medicine, Athens, Greece.'}, {'ForeName': 'Georgia-Angeliki', 'Initials': 'GA', 'LastName': 'Koliou', 'Affiliation': 'Section of Biostatistics, Hellenic Cooperative Oncology Group, Data Office, Athens, Greece.'}, {'ForeName': 'Kyriaki', 'Initials': 'K', 'LastName': 'Manousou', 'Affiliation': 'Section of Biostatistics, Hellenic Cooperative Oncology Group, Data Office, Athens, Greece.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Wirtz', 'Affiliation': 'STRATIFYER Molecular Pathology GmbH, Cologne, Germany.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Veltrup', 'Affiliation': 'STRATIFYER Molecular Pathology GmbH, Cologne, Germany.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Patsea', 'Affiliation': 'Department of Pathology, IASSO General Hospital, Athens, Greece.'}, {'ForeName': 'Nikiforita', 'Initials': 'N', 'LastName': 'Poulakaki', 'Affiliation': 'Breast Surgery Clinic, Euroclinic, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Dionysopoulos', 'Affiliation': 'Department of Medical Oncology, Papageorgiou Hospital, Aristotle University of Thessaloniki, School of Health Sciences, Faculty of Medicine, Thessaloniki, Greece.'}, {'ForeName': 'Stavroula', 'Initials': 'S', 'LastName': 'Pervana', 'Affiliation': 'Department of Pathology, Papageorgiou Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Gogas', 'Affiliation': 'First Department of Medicine, Laiko General Hospital, National and Kapodistrian University of Athens School of Medicine, Athens, Greece.'}, {'ForeName': 'Angelos', 'Initials': 'A', 'LastName': 'Koutras', 'Affiliation': 'Division of Oncology, Department of Medicine, University Hospital, University of Patras Medical School, Patras, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Pentheroudakis', 'Affiliation': 'Department of Medical Oncology, Ioannina University Hospital, Ioannina, Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Christodoulou', 'Affiliation': 'Second Department of Medical Oncology, Metropolitan Hospital, Piraeus, Greece.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Linardou', 'Affiliation': 'Oncology Unit, Metropolitan Hospital, Piraeus, Greece.'}, {'ForeName': 'Kitty', 'Initials': 'K', 'LastName': 'Pavlakis', 'Affiliation': 'Pathology Department, National and Kapodistrian University of Athens School of Medicine, Athens, Greece.'}, {'ForeName': 'Triantafyllia', 'Initials': 'T', 'LastName': 'Koletsa', 'Affiliation': 'Department of Pathology, Aristotle University of Thessaloniki, School of Health Sciences, Faculty of Medicine, Thessaloniki, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Pectasides', 'Affiliation': 'Oncology Section, Second Department of Internal Medicine, Hippokration Hospital, Athens, Greece.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Zagouri', 'Affiliation': 'Department of Clinical Therapeutics, Alexandra Hospital, National and Kapodistrian University of Athens School of Medicine, Athens, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Fountzilas', 'Affiliation': 'Laboratory of Molecular Oncology, Hellenic Foundation for Cancer Research/Aristotle University of Thessaloniki, Thessaloniki, Greece; Aristotle University of Thessaloniki, Thessaloniki, Greece.'}]",Clinical breast cancer,['10.1016/j.clbc.2019.08.008']
2708,31832719,Nicotine enhances auditory processing in healthy and normal-hearing young adult nonsmokers.,"RATIONALE


Electrophysiological studies show that systemic nicotine narrows frequency receptive fields and increases gain in neural responses to characteristic frequency stimuli. We postulated that nicotine enhances related auditory processing in humans.
OBJECTIVES


The main hypothesis was that nicotine improves auditory performance. A secondary hypothesis was that the degree of nicotine-induced improvement depends on the individual's baseline performance.
METHODS


Young (18-27 years old), normal-hearing nonsmokers received nicotine (Nicorette gum, 6mg) or placebo gum in a single-blind, randomized, crossover design. Subjects performed four experiments involving tone-in-noise detection, temporal gap detection, spectral ripple discrimination, and selective auditory attention before and after treatment. The perceptual differences between posttreatment nicotine and placebo conditions were measured and analyzed as a function of the pre-treatment baseline performance.
RESULTS


Nicotine significantly improved performance in the more difficult tasks of tone-in-noise detection and selective attention (effect size = - 0.3) but had no effect on relatively easier tasks of temporal gap detection and spectral ripple discrimination. The two tasks showing significant nicotine effects further showed no baseline-dependent improvement.
CONCLUSIONS


Nicotine improves auditory performance in difficult listening situations. The present results support future investigation of nicotine effects in clinical populations with auditory processing deficits or reduced cholinergic activation.",2020,"RESULTS


Nicotine significantly improved performance in the more difficult tasks of tone-in-noise detection and selective attention (effect size = - 0.3) but had no effect on relatively easier tasks of temporal gap detection and spectral ripple discrimination.","['healthy and normal-hearing young adult nonsmokers', 'humans', 'Young (18-27\xa0years old), normal-hearing nonsmokers received']","['Nicotine', 'nicotine (Nicorette gum, 6mg) or placebo gum', 'nicotine']","['auditory processing', 'auditory performance']","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4554605', 'cui_str': 'Nonsmokers'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0701400', 'cui_str': 'Nicorette'}, {'cui': 'C1378701', 'cui_str': 'Gum (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}]",,0.0916366,"RESULTS


Nicotine significantly improved performance in the more difficult tasks of tone-in-noise detection and selective attention (effect size = - 0.3) but had no effect on relatively easier tasks of temporal gap detection and spectral ripple discrimination.","[{'ForeName': 'Carol Q', 'Initials': 'CQ', 'LastName': 'Pham', 'Affiliation': 'Center for Hearing Research, University of California, Irvine, CA, USA.'}, {'ForeName': 'Michelle R', 'Initials': 'MR', 'LastName': 'Kapolowicz', 'Affiliation': 'Center for Hearing Research, University of California, Irvine, CA, USA.'}, {'ForeName': 'Raju', 'Initials': 'R', 'LastName': 'Metherate', 'Affiliation': 'Center for Hearing Research, University of California, Irvine, CA, USA.'}, {'ForeName': 'Fan-Gang', 'Initials': 'FG', 'LastName': 'Zeng', 'Affiliation': 'Center for Hearing Research, University of California, Irvine, CA, USA. fzeng@uci.edu.'}]",Psychopharmacology,['10.1007/s00213-019-05421-x']
2709,32094516,Effects of hybrid-functional electrical stimulation (FES) rowing whole-body exercise on neurologic improvement in subacute spinal cord injury: secondary outcomes analysis of a randomized controlled trial.,"STUDY DESIGN


Secondary outcome measures analysis of a randomized, controlled study.
OBJECTIVE


To assess the effects of hybrid-functional electrical stimulation (FES) rowing on motor and sensory recovery in individuals with spinal cord injury (SCI) 6-18 months post injury.
SETTING


Outpatient rehabilitation network.
METHODS


25 participants 6-12 months after SCI were randomly assigned to hybrid-FES rowing (n = 10) or standard of care (n = 15) groups. The hybrid-FES rowing group completed 6 months of rowing scheduled 3 times per week for 26 weeks at an exercise intensity of 70-85% of maximal heart rate. The standard of care group either participated in an arm ergometer exercise program (n = 6) or a waitlist without an explicit exercise program (n = 9). Changes in motor score and combined sensory score of the International Standards for Neurological Classification of SCI (ISNCSCI) were analyzed.
RESULTS


Both groups demonstrated increases in motor and combined sensory scores, but no significant differences were noted between intervention groups (motor difference mean ↑1.3 (95% CI, -1.9 to 4.4), combined sensory difference mean ↓10 (-30 to 18)). There was an average of 63% adherence to the hybrid-FES rowing protocol, with no significant correlation in changes in motor or combined sensory score in the hybrid-FES rowing group with total distance or time rowed.
CONCLUSIONS


No significant effects to neurologic improvement were found with hybrid-FES rowing when compared with standard of care interventions in individuals with SCI 6-18 months post injury.",2020,No significant effects to neurologic improvement were found with hybrid-FES rowing when compared with standard of care interventions in individuals with SCI 6-18 months post injury.,"['individuals with spinal cord injury (SCI) 6-18 months post injury', '25 participants 6-12 months after SCI', 'Outpatient rehabilitation network', 'subacute spinal cord injury']","['hybrid-FES rowing', 'hybrid-functional electrical stimulation (FES) rowing', 'hybrid-FES rowing (n\u2009=\u200910) or standard of care', 'hybrid-functional electrical stimulation (FES) rowing whole-body exercise', 'care group either participated in an arm ergometer exercise program (n\u2009=\u20096) or a waitlist without an explicit exercise program']","['motor score and combined sensory score', 'motor and combined sensory scores', 'motor or combined sensory score', 'neurologic improvement']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}]","[{'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0674267', 'cui_str': 'greigite'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}]",25.0,0.116675,No significant effects to neurologic improvement were found with hybrid-FES rowing when compared with standard of care interventions in individuals with SCI 6-18 months post injury.,"[{'ForeName': 'Raymond C', 'Initials': 'RC', 'LastName': 'Chou', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA, USA. rchou1@partners.org.'}, {'ForeName': 'J Andrew', 'Initials': 'JA', 'LastName': 'Taylor', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Solinsky', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA, USA.'}]",Spinal cord,['10.1038/s41393-020-0445-3']
2710,32001397,Early Intensive Rehabilitation for Patients with Traumatic Brain Injury: A Prospective Pilot Trial.,"OBJECTIVE


To investigate the effects of early intensive rehabilitation management on the recovery of motor function and activities of daily living in patients with moderate traumatic brain injury.
METHODS


Eighty-seven patients (age range, 18-65 years) with traumatic brain injury that met the enrollment criteria were randomly divided into 2 groups. Group 1 received early and high-intensity rehabilitation management (from 7 days after injury, 7 d/wk, 4 times/d, 1 h/session) for 4 weeks; group 2 received ordinary rehabilitation (from 14 days after injury, 5 d/wk, 2 times/d, 1 h/session) for 4 weeks. The Fugl-Meyer Assessment (FMA, motor function) and Barthel Index (BI) were used to assess the daily living functional state before treatment, 3 months after injury, and 6 months after injury. The Glasgow Coma Scale (GCS) was used to assess outcomes 6 months after injury.
RESULTS


Three months after rehabilitation, the FMA (motor function) score was significantly higher in the early intensive intervention group versus the control group (59.83 ± 11.87 vs. 44.56 ± 8.32, respectively; P < 0.05); no significant between-group differences were found in the GCS score or BI score (P > 0.05). Six months after rehabilitation, the FMA score and BI score were significantly higher in the early intensive intervention group versus the control group (FMA: 73.18 ± 16.55 vs. 57.86 ± 10.67, P < 0.01; BI: 87.17 ± 13.85 vs. 60.68 ± 11.98, P < 0.01, respectively). The GCS score was higher in the early intensive intervention group versus the control group (4.24 ± 0.91 vs. 3.43 ± 0.88, P < 0.05, respectively) 6 months after injury.
CONCLUSIONS


Early intensive rehabilitation management might be more beneficial for neurologic function and activities of daily living in patients with moderate traumatic brain injury.",2020,"Six months after rehabilitation, the FMA score and BI score were significantly higher in Early Intensive Intervention group vs. Control group (FMA: 73.18±16.55 vs. 57.86±10.67, P<0.01; BI: 87.17±13.85 vs. 60.68±11.98, P<0.01).","['patients with traumatic brain injury', 'Eighty-seven patients (age range 18-65 years) with traumatic brain injury that met the enrolment criteria', 'patients with moderate traumatic brain injury']","['early intensive rehabilitation management', 'ordinary rehabilitation', 'early and high-intensity rehabilitation management']","['GOS score or BI', 'FMA score and BI score', 'Glasgow Coma Scale (GOS', 'daily living functional state', 'GOS score', 'FMA (motor function) score', 'Fugl-Meyer Assessment (FMA, motor function) and Barthel Index (BI', 'recovery of motor and activities of daily living']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}]",87.0,0.0557411,"Six months after rehabilitation, the FMA score and BI score were significantly higher in Early Intensive Intervention group vs. Control group (FMA: 73.18±16.55 vs. 57.86±10.67, P<0.01; BI: 87.17±13.85 vs. 60.68±11.98, P<0.01).","[{'ForeName': 'Ming-Chao', 'Initials': 'MC', 'LastName': 'Fan', 'Affiliation': 'Department of Neurosurgery The Affiliated Hospital of Qingdao University, Qingdao, China; Neurosurgical Intensive Care Unit The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Shi-Fang', 'Initials': 'SF', 'LastName': 'Li', 'Affiliation': 'Department of Neurosurgery The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Sun', 'Affiliation': 'Department of Neurosurgery The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Guang-Tao', 'Initials': 'GT', 'LastName': 'Bai', 'Affiliation': 'Department of Rehabilitation Medicine, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Nian', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Neurosurgical Intensive Care Unit The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Department of Rehabilitation Medicine, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Neurosurgical Intensive Care Unit The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Neurosurgical Intensive Care Unit The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Huan-Ting', 'Initials': 'HT', 'LastName': 'Li', 'Affiliation': 'Department of Neurosurgery The Affiliated Hospital of Qingdao University, Qingdao, China. Electronic address: fanmcqd@163.com.'}]",World neurosurgery,['10.1016/j.wneu.2020.01.113']
2711,31522846,"Laparoscopic supracervical hysterectomy versus endometrial ablation for women with heavy menstrual bleeding (HEALTH): a parallel-group, open-label, randomised controlled trial.","BACKGROUND


Heavy menstrual bleeding affects 25% of women in the UK, many of whom require surgery to treat it. Hysterectomy is effective but has more complications than endometrial ablation, which is less invasive but ultimately leads to hysterectomy in 20% of women. We compared laparoscopic supracervical hysterectomy with endometrial ablation in women seeking surgical treatment for heavy menstrual bleeding.
METHODS


In this parallel-group, multicentre, open-label, randomised controlled trial in 31 hospitals in the UK, women younger than 50 years who were referred to a gynaecologist for surgical treatment of heavy menstrual bleeding and who were eligible for endometrial ablation were randomly allocated (1:1) to either laparoscopic supracervical hysterectomy or second generation endometrial ablation. Women were randomly assigned by either an interactive voice response telephone system or an internet-based application with a minimisation algorithm based on centre and age group (<40 years vs ≥40 years). Laparoscopic supracervical hysterectomy involves laparoscopic (keyhole) surgery to remove the upper part of the uterus (the body) containing the endometrium. Endometrial ablation aims to treat heavy menstrual bleeding by destroying the endometrium, which is responsible for heavy periods. The co-primary clinical outcomes were patient satisfaction and condition-specific quality of life, measured with the menorrhagia multi-attribute quality of life scale (MMAS), assessed at 15 months after randomisation. Our analysis was based on the intention-to-treat principle. The trial was registered with the ISRCTN registry, number ISRCTN49013893.
FINDINGS


Between May 21, 2014, and March 28, 2017, we enrolled and randomly assigned 660 women (330 in each group). 616 (93%) of 660 women were operated on within the study period, 588 (95%) of whom received the allocated procedure and 28 (5%) of whom had an alternative surgery. At 15 months after randomisation, more women allocated to laparoscopic supracervical hysterectomy were satisfied with their operation compared with those in the endometrial ablation group (270 [97%] of 278 women vs 244 [87%] of 280 women; adjusted percentage difference 9·8, 95% CI 5·1-14·5; adjusted odds ratio [OR] 2·53, 95% CI 1·83-3·48; p<0·0001). Women randomly assigned to laparoscopic supracervical hysterectomy were also more likely to have the best possible MMAS score of 100 than women assigned to endometrial ablation (180 [69%] of 262 women vs 146 [54%] of 268 women; adjusted percentage difference 13·3, 95% CI 3·8-22·8; adjusted OR 1·87, 95% CI 1·31-2·67; p=0·00058). 14 (5%) of 309 women in the laparoscopic supracervical hysterectomy group and 11 (4%) of 307 women in the endometrial ablation group had at least one serious adverse event (adjusted OR 1·30, 95% CI 0·56-3·02; p=0·54).
INTERPRETATION


Laparoscopic supracervical hysterectomy is superior to endometrial ablation in terms of clinical effectiveness and has a similar proportion of complications, but takes longer to perform and is associated with a longer recovery.
FUNDING


UK National Institute for Health Research Health Technology Assessment Programme.",2019,"At 15 months after randomisation, more women allocated to laparoscopic supracervical hysterectomy were satisfied with their operation compared with those in the endometrial ablation group (270 [97%] of 278 women vs 244 [87%] of 280 women; adjusted percentage difference 9·8, 95% CI 5·1-14·5; adjusted odds ratio [OR] 2·53, 95% CI 1·83-3·48; p<0·0001).","['262 women vs 146 [54%] of 268 women', 'women with heavy menstrual bleeding (HEALTH', '616 (93%) of 660 women were operated on within the study period, 588 (95%) of whom received the allocated procedure and 28 (5%) of whom had an alternative surgery', 'women seeking surgical treatment for heavy menstrual bleeding', '309 women in the laparoscopic supracervical hysterectomy group and 11 (4%) of 307 women in the', 'Between May 21, 2014, and March 28, 2017, we enrolled and randomly assigned 660 women (330 in each group', '31 hospitals in the UK, women younger than 50 years who were referred to a gynaecologist for surgical treatment of heavy menstrual bleeding and who were eligible for endometrial ablation']","['Hysterectomy', 'Laparoscopic supracervical hysterectomy involves laparoscopic (keyhole) surgery', 'endometrial ablation', 'laparoscopic supracervical hysterectomy', 'interactive voice response telephone system or an internet-based application with a minimisation algorithm based on centre and age group', 'laparoscopic supracervical hysterectomy with endometrial ablation', 'laparoscopic supracervical hysterectomy or second generation endometrial ablation', 'Endometrial ablation', 'Laparoscopic supracervical hysterectomy versus endometrial ablation']","['patient satisfaction and condition-specific quality of life, measured with the menorrhagia multi-attribute quality of life scale (MMAS', 'serious adverse event']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0025323', 'cui_str': 'Heavy Menstrual Bleeding'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0404091', 'cui_str': 'Laparoscopic supracervical hysterectomy (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237419', 'cui_str': 'Gynecologist (occupation)'}, {'cui': 'C0341803', 'cui_str': 'Endometrial Ablation'}]","[{'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0404091', 'cui_str': 'Laparoscopic supracervical hysterectomy (procedure)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0341803', 'cui_str': 'Endometrial Ablation'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0002045'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]","[{'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0025323', 'cui_str': 'Heavy Menstrual Bleeding'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0449234', 'cui_str': 'Attribute (attribute)'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",660.0,0.274659,"At 15 months after randomisation, more women allocated to laparoscopic supracervical hysterectomy were satisfied with their operation compared with those in the endometrial ablation group (270 [97%] of 278 women vs 244 [87%] of 280 women; adjusted percentage difference 9·8, 95% CI 5·1-14·5; adjusted odds ratio [OR] 2·53, 95% CI 1·83-3·48; p<0·0001).","[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Cooper', 'Affiliation': 'NHS Grampian, Aberdeen Royal Infirmary, Aberdeen, UK. Electronic address: kevincooper@nhs.net.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Breeman', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Neil W', 'Initials': 'NW', 'LastName': 'Scott', 'Affiliation': 'Medical Statistics Team, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Scotland', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK; Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Clark', 'Affiliation': ""Birmingham Women's and Children's NHS Foundation Trust, Birmingham Women's and Children's Hospital, Birmingham, UK.""}, {'ForeName': 'Jed', 'Initials': 'J', 'LastName': 'Hawe', 'Affiliation': 'Countess of Chester Hospital NHS Foundation Trust, Chester, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hawthorn', 'Affiliation': 'NHS Greater Glasgow and Clyde, Southern General Hospital, Glasgow, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Phillips', 'Affiliation': 'Hull and East Yorkshire Hospitals NHS Trust, Castle Hill Hospital, Cottingham, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Wileman', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'McCormack', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Hernández', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, Centre for Population Health Sciences, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Siladitya', 'Initials': 'S', 'LastName': 'Bhattacharya', 'Affiliation': 'Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)31790-8']
2712,32067777,"Randomised trial on performance, safety and clinical benefit of hyaluronic acid, hyaluronic acid plus dexpanthenol and isotonic saline nasal sprays in patients suffering from dry nose symptoms.","OBJECTIVE


Limited data exist on the clinical benefits of nasal applications for moistening the nasal mucosa. We therefore investigated the effects of hyaluronic acid, hyaluronic acid plus dexpanthenol and isotonic saline nasal sprays in patients suffering from dry nose symptoms in an otorhinolaryngological outpatient setting.
METHODS


240 patients were randomised into this prospective, three-armed clinical trial with two assessment points (baseline and 4 weeks later). Patients received either hyaluronic acid, hyaluronic acid plus dexpanthenol or isotonic saline nasal spray over a period of four weeks. Rhinitis Sicca Symptom Score (RSSS) was assessed as primary endpoint, and individual symptoms and tolerability of all treatments as secondary endpoints. Patient perceptions after first application of the allocated nasal spray were recorded using the Nasal Spray Sensory Scale. Treatment effects were analysed for each study arm first and subsequently compared against each other.
RESULTS


RSSS (hyaluronic acid: mean difference = 8.90 [98.33% CI = 7.34/10.45]; hyaluronic acid plus dexpanthenol: mean difference = 8.42 [98.33% CI = 6.91/9.94]; isotonic saline: mean difference = 8.94 [98.33% CI = 7.33/10.54]), individual symptoms and Endoscopy Score improved significantly (p < 0.001) in all treatment arms. Tolerability was assessed as ""flawless"" in more than 85% of all treatments, which is reflected in overall high rankings in the Nasal Spray Sensory Scale. Perception of nasal moisturisation was reported to be significantly higher in patients receiving hyaluronic acid plus dexpanthenol as compared to patients receiving hyaluronic acid or isotonic saline. No further significant differences were observed between the three treatments.
CONCLUSION


All three tested sprays (hyaluronic acid, hyaluronic acid plus dexpanthenol and isotonic saline) proved to be suitable treatments for patients suffering from dry nose symptoms. (DRKS-ID: DRKS00013357).",2020,Perception of nasal moisturisation was reported to be significantly higher in patients receiving hyaluronic acid plus dexpanthenol as compared to patients receiving hyaluronic acid or isotonic saline.,"['patients suffering from dry nose symptoms in an otorhinolaryngological outpatient setting', 'patients suffering from dry nose symptoms', '240 patients']","['isotonic saline', 'RSSS (hyaluronic acid', 'hyaluronic acid plus dexpanthenol', 'hyaluronic acid, hyaluronic acid plus dexpanthenol or isotonic saline nasal spray', 'sprays (hyaluronic acid, hyaluronic acid plus dexpanthenol and isotonic saline', 'hyaluronic acid, hyaluronic acid plus dexpanthenol and isotonic saline nasal sprays', 'hyaluronic acid or isotonic saline']","['Nasal Spray Sensory Scale', 'Tolerability', 'Rhinitis Sicca Symptom Score (RSSS', 'individual symptoms and Endoscopy Score', 'Perception of nasal moisturisation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231919', 'cui_str': 'Nasal mucosa dry (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}]","[{'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0057610', 'cui_str': '(+)-Panthenol'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C4521772', 'cui_str': 'Spray'}]","[{'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0339800', 'cui_str': 'Rhinitis sicca (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}]",240.0,0.12788,Perception of nasal moisturisation was reported to be significantly higher in patients receiving hyaluronic acid plus dexpanthenol as compared to patients receiving hyaluronic acid or isotonic saline.,"[{'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Thieme', 'Affiliation': 'ENT praxis, Mercatorstraße 10-12, 47051 Duisburg, Germany.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Müller', 'Affiliation': 'Center for Clinical Studies, University Hospital Regensburg, 93042 Regensburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bergmann', 'Affiliation': 'ENT praxis Ruhr, Bocholder Straße 2, 45355 Essen, Germany.'}, {'ForeName': 'Bernward', 'Initials': 'B', 'LastName': 'Bock', 'Affiliation': 'ENT praxis, Am Krankenhaus 1, 31655 Stadthagen, Germany.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Wurzer-Materna', 'Affiliation': 'ENT praxis, Hofackerstraße 19, 86179 Augsburg, Germany.'}, {'ForeName': 'Taufik', 'Initials': 'T', 'LastName': 'Shahab', 'Affiliation': 'ENT praxis, Neumarkt 41, 50667 Köln, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Zeman', 'Affiliation': 'Center for Clinical Studies, University Hospital Regensburg, 93042 Regensburg, Germany.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Eberhardt', 'Affiliation': 'Center for Clinical Studies, University Hospital Regensburg, 93042 Regensburg, Germany.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Huppertz', 'Affiliation': 'Center for Clinical Studies, University Hospital Regensburg, 93042 Regensburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Koller', 'Affiliation': 'Center for Clinical Studies, University Hospital Regensburg, 93042 Regensburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Meiser', 'Affiliation': 'Ursapharm Arzneimittel GmbH, Industriestraße 35, 66129 Saarbrücken, Germany. Electronic address: p.meiser@ursapharm.de.'}]","Auris, nasus, larynx",['10.1016/j.anl.2020.01.008']
2713,32078078,Then We Looked at His Results: Men Who Have Sex With Men from New York City and Puerto Rico Report Their Sexual Partner's Reactions to Receiving Reactive HIV Self-Test Results.,"Secondary distribution of HIV self-tests to sexual partners is acceptable but concerns remain about reactions if a partner tests HIV-positive. We report on 14 participants whose sexual partners tested HIV-positive during the ""I'll Show You Mine"" Study, a randomized controlled trial (N = 272) of HIV self- and partner-testing among men who have sex with men (MSM) and transgender women (TGW). All 14 were MSM and racial/ethnic minorities, mean age was 36.6 years; 86% were gay-identified. Twenty-four partners tested positive; about half were new partners. Six participants had multiple partners test positive. During in-depth interviews with 10 of these participants, they reported their partners' reactions ranged from tearful and worried among those whose result was unexpected, to resignation among those who suspected a positive result, to nonchalance among partners who participants concluded knew of their HIV infection. After testing, some HIV-positive partners disclosed prior knowledge of their status. No partner reacted violently. Participants typically comforted their partners and encouraged confirmatory testing. Four participants had anal intercourse with partners who tested positive. Participants and partners were able to effectively handle situations in which the partner tested HIV-positive.",2020,No partner reacted violently.,"['Six participants had multiple partners test positive', 'All 14 were MSM and racial/ethnic minorities, mean age was 36.6\xa0years; 86% were gay-identified', 'Participants typically comforted their partners and encouraged confirmatory testing', 'Four participants had anal intercourse with partners who tested positive', '14 participants whose sexual partners tested HIV-positive during the ""I\'ll Show You Mine"" Study, a randomized controlled trial (N\u2009=\u2009272) of HIV self- and partner-testing among men who have sex with men (MSM) and transgender women (TGW']",[],['knew of their HIV infection'],"[{'cui': 'C0026767', 'cui_str': 'Multiple Partners'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration (finding)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0036911', 'cui_str': 'Sexual Partners'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}]",[],"[{'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}]",14.0,0.0277884,No partner reacted violently.,"[{'ForeName': 'Iván C', 'Initials': 'IC', 'LastName': 'Balán', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA. ivan.balan@nyspi.columbia.edu.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Lopez-Rios', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Giguere', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Lentz', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Dolezal', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cruz Torres', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Brown', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Raynier', 'Initials': 'R', 'LastName': 'Crespo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Sheinfil', 'Affiliation': 'Department of Psychology, Syracuse University, Syracuse, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Tagliaferri Rael', 'Affiliation': 'Department of Psychology, Syracuse University, Syracuse, USA.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Febo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Carballo-Diéguez', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02816-2']
2714,31081596,A pilot randomized controlled trial to improve sleep and fatigue in children with central nervous system tumors hospitalized for high-dose chemotherapy.,"OBJECTIVES


To determine whether a sleep intervention compared with standard of care (SOC) was successful in preserving nighttime sleep in children with central nervous system cancers hospitalized for high-dose chemotherapy (HDCT) and autologous stem cell rescue, and to explore associations between sleep and fatigue during treatment.
METHODS


An unblinded, randomized, controlled, multicomponent intervention (NCT00666614) including evidence-based cognitive and behavioral strategies to improve sleep was implemented in 33 children (age 4-12 years) and adolescents (age 13-19 years) during hospitalization. Children wore an actigraph to measure sleep and wake, and reported fatigue scores daily. Parents concurrently kept a sleep diary and reported fatigue scores for their children.
RESULTS


The mean age was 9.5 ± 3.9 years, 81.8% were white, and 60.6% were male. Sleep in all children was seriously disturbed throughout the study. Children in the intervention group maintained their longest nighttime sleep across the study, while it declined in children receiving SOC (P = 0.009 for interaction). There were few other differences in sleep between groups. Controlling for age and baseline fatigue, higher nighttime activity score, and lower percent sleep were significantly associated with higher next-day adolescent-reported fatigue (P < 0.05); longest sleep was significantly positively associated with next-day child-reported fatigue (P = 0.018).
CONCLUSION


In this sample of children undergoing HDCT, a multicomponent sleep intervention modestly preserved nighttime sleep duration, although overall sleep was poor in both groups. Sleep is an integral component of health, and may influence outcomes of children receiving HDCT. Further investigation into methods of preserving sleep in children undergoing intensive cancer therapy is warranted.",2019,"Controlling for age and baseline fatigue, higher nighttime activity score, and lower percent sleep were significantly associated with higher next-day adolescent-reported fatigue (P < 0.05); longest sleep was significantly positively associated with next-day child-reported fatigue (P = 0.018).
","['33 children (age 4-12 years) and adolescents (age 13-19 years) during hospitalization', 'children receiving HDCT', 'children with central nervous system tumors hospitalized for high-dose chemotherapy', 'children undergoing intensive cancer therapy', 'children with central nervous system cancers hospitalized for high-dose chemotherapy (HDCT) and autologous stem cell rescue', 'The mean age was 9.5 ± 3.9 years, 81.8% were white, and 60.6% were male']","['HDCT', 'multicomponent sleep intervention', 'sleep intervention compared with standard of care (SOC']","['Sleep', 'longest nighttime sleep', 'nighttime activity score', 'longest sleep', 'nighttime sleep duration', 'fatigue scores', 'overall sleep', 'sleep and fatigue']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0085136', 'cui_str': 'Tumors, Central Nervous System'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C4517698', 'cui_str': '3.9 (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",33.0,0.0564435,"Controlling for age and baseline fatigue, higher nighttime activity score, and lower percent sleep were significantly associated with higher next-day adolescent-reported fatigue (P < 0.05); longest sleep was significantly positively associated with next-day child-reported fatigue (P = 0.018).
","[{'ForeName': 'Valerie E', 'Initials': 'VE', 'LastName': 'Rogers', 'Affiliation': 'University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'Shijun', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Ancoli-Israel', 'Affiliation': 'University of California, San Diego, California.'}, {'ForeName': 'Lianqi', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'University of California, San Diego, California.'}, {'ForeName': 'Belinda N', 'Initials': 'BN', 'LastName': 'Mandrell', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Hinds', 'Affiliation': ""Children's National Health System, George Washington University, Washington, District of Columbia.""}]",Pediatric blood & cancer,['10.1002/pbc.27814']
2715,32068572,Effect of an ultrasound-guided lung recruitment manoeuvre on postoperative atelectasis in children: A randomised controlled trial.,"BACKGROUND


Ultrasound-guided alveolar recruitment, regardless of the technique, could be more effective because it facilitates real-time monitoring of the expansion of collapsed alveoli.
OBJECTIVES


To evaluate and compare the effects of an ultrasound-guided lung recruitment manoeuvre with those of a conventional recruitment manoeuvre on the occurrence of postoperative atelectasis and clinical outcomes in children.
DESIGN


A randomised controlled trial.
SETTING


Tertiary children's hospital.
PATIENTS


Children aged 6 years or less.
INTERVENTION


Children scheduled for simple, superficial procedures underwent lung ultrasound after tracheal intubation (T1), at the end of surgery (T2) and before discharge from the postanaesthesia care unit (T3). Following lung ultrasound evaluation at T1 and T2, the conventional recruitment manoeuvre with a maximal airway pressure of 30 cmH2O was performed in the control group, while an ultrasound-guided recruitment manoeuvre was performed in the ultrasound group.
MAIN OUTCOME MEASURES


The primary outcome was the incidence of significant atelectasis at T3.
RESULTS


The incidences of atelectasis at T3 were 20.9 and 11.6% in the control (n = 43) and ultrasound groups (n = 43), respectively (odds ratio [OR], 2.012; 95% confidence interval [CI], 0.614 to 6.594; P = 0.249). The lung ultrasound scores were better in the ultrasound group than in the control group at T2 and T3, and the incidence of postoperative desaturation was higher in the control group than in the ultrasound group (16.3 vs. 2.3%; OR, 0.12; 95% CI 0.01 to 1.04; P = 0.05). The median airway pressure required for full lung expansion in the ultrasound group was 35 cmH2O at T1 and T2. Other postoperative outcomes were similar between groups.
CONCLUSION


Ultrasound-guided lung recruitment may be more effective than the conventional procedure in terms of the prevention of intra-operative atelectasis and postoperative desaturation; however, its beneficial effects on postoperative atelectasis remain unclear. An inspiratory airway pressure of more than 30 cmH2O is required for full recruitment of alveoli in healthy children.
CLINICAL TRIAL REGISTRY


ClinicalTrials.gov (NCT03453762).",2020,"The lung ultrasound scores were better in the ultrasound group than in the control group at T2 and T3, and the incidence of postoperative desaturation was higher in the control group than in the ultrasound group (16.3 vs. 2.3%; OR, 0.12; 95% CI 0.01 to 1.04; P = 0.05).","['healthy children', 'Children aged 6 years or less', ""Tertiary children's hospital"", 'children']","['Children scheduled for simple, superficial procedures underwent lung ultrasound after tracheal intubation (T1', 'ultrasound-guided lung recruitment manoeuvre']","['incidences of atelectasis', 'lung ultrasound scores', 'incidence of significant atelectasis at T3', 'incidence of postoperative desaturation', 'median airway pressure required for full lung expansion']","[{'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0004144', 'cui_str': 'Lung Collapse'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0024109', 'cui_str': 'Lung'}]",,0.192551,"The lung ultrasound scores were better in the ultrasound group than in the control group at T2 and T3, and the incidence of postoperative desaturation was higher in the control group than in the ultrasound group (16.3 vs. 2.3%; OR, 0.12; 95% CI 0.01 to 1.04; P = 0.05).","[{'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'From the Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seungeun', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'Sang-Hwan', 'Initials': 'SH', 'LastName': 'Ji', 'Affiliation': ''}, {'ForeName': 'Young-Eun', 'Initials': 'YE', 'LastName': 'Jang', 'Affiliation': ''}, {'ForeName': 'Eun-Hee', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Hee-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Jin-Tae', 'Initials': 'JT', 'LastName': 'Kim', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001175']
2716,31965830,Multiple psychological factors predict pain and disability among community-dwelling knee osteoarthritis patients: a five-year prospective study.,"OBJECTIVE


To identify predictors of long-term pain and disability in knee osteoarthritis.
DESIGN


A longitudinal cohort study of five years.
SETTING


Primary care providers.
SUBJECTS


In all, 108 patients (mean age = 63.6 years, standard deviation (SD) = 7.2 years) with knee pain (⩾40 mm on a 100 mm visual analogue scale in the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index pain scale) and radiographic grading (Kellgren-Lawrence: 2-4) of knee osteoarthritis who participated in a randomized controlled trial.
MAIN MEASURES


Disease-specific pain and functioning were assessed using the corresponding WOMAC subscales. Generic functioning was assessed by the RAND-36 subscales for function and physical and mental component summary scores. Possible baseline predictors for these outcomes were (1) demographic and disease-related variables and (2) psychological variables of mood (anxiety, depression), pain-related cognitions (pain self-efficacy, pain catastrophizing, kinesiophobia), and positive resource factors (life satisfaction, sense of coherence).
RESULTS


Multivariate linear mixed model analyses revealed that minimal anxiety at baseline predicted significantly better results for pain (WOMAC,  P  = 0.019) and function (WOMAC,  P  = 0.001, RAND-36 function  P  = 0.001). High pain self-efficacy predicted significantly better scores in RAND-36 function ( P  = 0.006), physical ( P  = 0.004) and mental ( P  = 0.001) component summaries. Pain catastrophizing predicted higher pain ( P  = 0.015), whereas fear of movement predicted poorer functioning in RAND-36 physical ( P  = 0.016) and mental ( P  = 0.009) component summaries. Those satisfied with life reported higher scores in RAND-36 function ( P  = 0.002) and mental component summary ( P  = 0.041). A low number of comorbidities predicted significantly better results in pain (WOMAC  P  = 0.019) and function (WOMAC  P  = 0.033, RAND-36  P  = 0.009).
CONCLUSION


Anxiety, pain-related cognitions, and psychological resources predict symptoms in knee osteoarthritis in the long term.",2020,Those satisfied with life reported higher scores in RAND-36 function ( P  = 0.002) and mental component summary ( P  = 0.041).,"['community-dwelling knee osteoarthritis patients', '108 patients (mean age = 63.6 years, standard deviation (SD) = 7.2 years) with knee pain', 'Primary care providers']",[],"['Generic functioning', 'demographic and disease-related variables and (2) psychological variables of mood (anxiety, depression), pain-related cognitions (pain self-efficacy, pain catastrophizing, kinesiophobia), and positive resource factors (life satisfaction, sense of coherence', 'minimal anxiety', 'Disease-specific pain and functioning', 'pain (WOMAC', 'fear of movement predicted poorer functioning in RAND-36 physical', 'RAND-36 subscales for function and physical and mental component summary scores', 'RAND-36 function', 'High pain self-efficacy', 'pain']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}]",[],"[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3178983', 'cui_str': 'Salutogeneses'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",108.0,0.0674825,Those satisfied with life reported higher scores in RAND-36 function ( P  = 0.002) and mental component summary ( P  = 0.041).,"[{'ForeName': 'Eeva-Eerika', 'Initials': 'EE', 'LastName': 'Helminen', 'Affiliation': 'Mental Health and Substance Abuse, Social Services and Health Care, City of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jari Pa', 'Initials': 'JP', 'LastName': 'Arokoski', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Tuomas A', 'Initials': 'TA', 'LastName': 'Selander', 'Affiliation': 'Science Service Center, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Sanna H', 'Initials': 'SH', 'LastName': 'Sinikallio', 'Affiliation': 'School of Educational Sciences and Psychology, University of Eastern Finland, Kuopio, Finland.'}]",Clinical rehabilitation,['10.1177/0269215519900533']
2717,32074624,Cognitive Remediation Therapy Does Not Enhance Treatment Effect in Obsessive-Compulsive Disorder and Anorexia Nervosa: A Randomized Controlled Trial.,"BACKGROUND


Guideline-recommended therapies are moderately successful in the treatment of obsessive-compulsive disorder (OCD) and anorexia nervosa (AN), leaving room for improvement. Cognitive inflexibility, a common trait in both disorders, is likely to prevent patients from engaging in treatment and from fully benefiting from existing therapies. Cognitive remediation therapy (CRT) is a practical augmentation intervention aimed at ameliorating this impairing cognitive style prior to disorder-specific therapy.
OBJECTIVE


To compare the effectiveness of CRT and a control treatment that was not aimed at enhancing flexibility, named specialized attention therapy (SAT), as add-ons to treatment as usual (TAU).
METHODS


In a randomized controlled multicenter clinical trial, 71 adult patients with OCD and 61 with AN were randomized to ten twice-weekly sessions with either CRT or SAT, followed by TAU. Patients were evaluated at baseline, post-CRT/SAT, and after 6 and 12 months, with outcomes being quantified using the Yale-Brown Obsessive Compulsive Scale for OCD and the Eating Disorder Examination Questionnaire for AN.
RESULTS


Across study groups, most importantly CRT+TAU was not superior to control treatment (SAT)+TAU in reducing OCD and AN pathology. Contrary to expectations, SAT+TAU may have been more effective than CRT+TAU in patients being treated for OCD.
CONCLUSIONS


CRT did not enhance the effect of TAU for OCD and AN more than SAT. Unexpectedly, SAT, the control condition, may have had an augmentation effect on TAU in OCD patients. Although this latter finding may have been due to chance, the effect of SAT delivered as a pretreatment add-on intervention for adults with OCD and AN merits future efforts at replication.",2020,"To compare the effectiveness of CRT and a control treatment that was not aimed at enhancing flexibility, named specialized attention therapy (SAT), as add-ons to treatment as usual (TAU).
","['Obsessive-Compulsive Disorder and Anorexia Nervosa', 'adults with OCD', 'patients being treated for OCD', '71 adult patients with OCD and 61 with AN']","['Cognitive remediation therapy (CRT', 'Cognitive Remediation Therapy', 'CRT or SAT, followed by TAU', 'CRT']",['Yale-Brown Obsessive Compulsive Scale for OCD and the Eating Disorder Examination Questionnaire'],"[{'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}]","[{'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0222045'}, {'cui': 'C2960501', 'cui_str': 'Eating disorder examination questionnaire (assessment scale)'}]",71.0,0.119911,"To compare the effectiveness of CRT and a control treatment that was not aimed at enhancing flexibility, named specialized attention therapy (SAT), as add-ons to treatment as usual (TAU).
","[{'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'van Passel', 'Affiliation': 'Overwaal Center for Anxiety Disorders, OCD, and PTSD, Pro Persona Institute for Integrated Mental Health Care, Nijmegen, The Netherlands, b.van.passel@propersona.nl.'}, {'ForeName': 'Unna N', 'Initials': 'UN', 'LastName': 'Danner', 'Affiliation': 'Altrecht Eating Disorders Rintveld, Zeist, The Netherlands.'}, {'ForeName': 'Alexandra E', 'Initials': 'AE', 'LastName': 'Dingemans', 'Affiliation': 'Rivierduinen Eating Disorders Ursula, Leiden, The Netherlands.'}, {'ForeName': 'Emmeke', 'Initials': 'E', 'LastName': 'Aarts', 'Affiliation': 'Department of Methodology and Statistics, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Lot C', 'Initials': 'LC', 'LastName': 'Sternheim', 'Affiliation': 'Altrecht Eating Disorders Rintveld, Zeist, The Netherlands.'}, {'ForeName': 'Eni S', 'Initials': 'ES', 'LastName': 'Becker', 'Affiliation': 'Behavioral Science Institute, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Annemarie A', 'Initials': 'AA', 'LastName': 'van Elburg', 'Affiliation': 'Altrecht Eating Disorders Rintveld, Zeist, The Netherlands.'}, {'ForeName': 'Eric F', 'Initials': 'EF', 'LastName': 'van Furth', 'Affiliation': 'Rivierduinen Eating Disorders Ursula, Leiden, The Netherlands.'}, {'ForeName': 'Gert-Jan', 'Initials': 'GJ', 'LastName': 'Hendriks', 'Affiliation': 'Overwaal Center for Anxiety Disorders, OCD, and PTSD, Pro Persona Institute for Integrated Mental Health Care, Nijmegen, The Netherlands.'}, {'ForeName': 'Daniëlle C', 'Initials': 'DC', 'LastName': 'Cath', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, Utrecht, The Netherlands.'}]",Psychotherapy and psychosomatics,['10.1159/000505733']
2718,31372823,Circulating adipocyte fatty acid-binding protein is reduced by continuous positive airway pressure treatment for obstructive sleep apnea-a randomized controlled study.,"PURPOSE


The circulating level of adipocyte fatty acid-binding protein (AFABP), a biomarker with prognostic and therapeutic importance in metabolic disorders, has been shown to be elevated in obstructive sleep apnea (OSA). This randomized controlled study aimed to investigate the effect of continuous positive airway pressure (CPAP) treatment for OSA on AFABP levels.
METHODS


Consecutive subjects attending sleep study were invited if they were confirmed to have severe OSA and were free of metabolic diseases. Participants were randomized (1:1) into CPAP or observation group for 4 weeks. Demographics, anthropometric data, and circulating biomarkers were checked at baseline and after the 4-week study period.
RESULTS


Ninety subjects were randomized. The mean age was 46 ± 9 years old; 82% were male. Their mean body mass index (BMI) was 29 ± 5 kg/m 2 . By intention-to-treat approach, the CPAP group showed significant reductions in Epworth sleepiness scale and morning systolic blood pressure (- 7.2 mmHg, - 12.7 to - 1.7 mmHg, p = 0.011), but no significant difference in AFABP, adiponectin, C-reactive protein (CRP), and 8-isoprostane levels. In the per-protocol analysis, when only those who were compliant to CPAP were included, a significant reduction in AFABP (- 7.32 ng/ml, - 13.58, - 1.06, p = 0.023) were found in the CPAP-treated group compared with the control group, along with improvements in clinical parameters. Changes in AFABP were independently associated with both systolic blood pressure (β = 0.289, p = 0.028) and diastolic blood pressure (β = 0.217, p = 0.030).
CONCLUSION


CPAP therapy used regularly over 4 weeks for severe OSA lowered circulating AFABP level, suggesting a potential beneficial effect of OSA treatment on alleviating metabolic risks.
TRIAL REGISTRATION


The research protocol was registered at the National Institutes of Health clinical trials registry (NCT01173432).",2020,"The circulating level of adipocyte fatty acid-binding protein (AFABP), a biomarker with prognostic and therapeutic importance in metabolic disorders, has been shown to be elevated in obstructive sleep apnea (OSA).","['The mean age was 46\u2009±\u20099\xa0years old; 82% were male', 'Consecutive subjects attending sleep study', 'Ninety subjects were randomized', 'obstructive sleep apnea']","['OSA', 'continuous positive airway pressure treatment', 'CPAP', 'continuous positive airway pressure (CPAP']","['Epworth sleepiness scale and morning systolic blood pressure', 'AFABP', 'diastolic blood pressure', 'systolic blood pressure', 'AFABP, adiponectin, C-reactive protein (CRP), and 8-isoprostane levels', 'mean body mass index (BMI', 'Demographics, anthropometric data, and circulating biomarkers']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0295541', 'cui_str': '8-isoprostaglandin F2alpha'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",90.0,0.0737468,"The circulating level of adipocyte fatty acid-binding protein (AFABP), a biomarker with prognostic and therapeutic importance in metabolic disorders, has been shown to be elevated in obstructive sleep apnea (OSA).","[{'ForeName': 'Macy M S', 'Initials': 'MMS', 'LastName': 'Lui', 'Affiliation': 'Division of Respiratory and Critical Care Medicine, Department of Medicine, Queen Mary Hospital, University of Hong Kong, Pokfulam, Hong Kong SAR, China.'}, {'ForeName': 'Judith C W', 'Initials': 'JCW', 'LastName': 'Mak', 'Affiliation': 'Division of Respiratory and Critical Care Medicine, Department of Medicine, Queen Mary Hospital, University of Hong Kong, Pokfulam, Hong Kong SAR, China.'}, {'ForeName': 'Peony W C', 'Initials': 'PWC', 'LastName': 'Chong', 'Affiliation': 'Division of Respiratory and Critical Care Medicine, Department of Medicine, Queen Mary Hospital, University of Hong Kong, Pokfulam, Hong Kong SAR, China.'}, {'ForeName': 'David C L', 'Initials': 'DCL', 'LastName': 'Lam', 'Affiliation': 'Division of Respiratory and Critical Care Medicine, Department of Medicine, Queen Mary Hospital, University of Hong Kong, Pokfulam, Hong Kong SAR, China.'}, {'ForeName': 'Mary S M', 'Initials': 'MSM', 'LastName': 'Ip', 'Affiliation': 'Division of Respiratory and Critical Care Medicine, Department of Medicine, Queen Mary Hospital, University of Hong Kong, Pokfulam, Hong Kong SAR, China. msmip@hku.hk.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-019-01893-5']
2719,32071431,Early treatment with FCR versus watch and wait in patients with stage Binet A high-risk chronic lymphocytic leukemia (CLL): a randomized phase 3 trial.,"We report a randomized prospective phase 3 study (CLL7), designed to evaluate the efficacy of fludarabine, cyclophosphamide, and rituximab (FCR) in patients with an early-stage high-risk chronic lymphocytic leukemia (CLL). Eight hundred patients with untreated-stage Binet A disease were enrolled as intent-to-treat population and assessed for four prognostic markers: lymphocyte doubling time <12 months, serum thymidine kinase >10 U/L, unmutated IGHV genes, and unfavorable cytogenetics (del(11q)/del(17p)/trisomy 12). Two hundred and one patients with ≥2 risk features were classified as high-risk CLL and 1:1 randomized to receive either immediate therapy with 6xFCR (Hi-FCR, 100 patients), or to be observed according to standard of care (Hi-W&W, 101 patients). The overall response rate after early FCR was 92.7%. Common adverse events were hematological toxicities and infections (61.0%/41.5% of patients, respectively). After median observation time of 55.6 (0-99.2) months, event-free survival was significantly prolonged in Hi-FCR compared with Hi-W&W patients (median not reached vs. 18.5 months, p < 0.001). There was no significant overall survival benefit for high-risk patients receiving early FCR therapy (5-year OS 82.9% in Hi-FCR vs. 79.9% in Hi-W&W, p = 0.864). In conclusion, although FCR is efficient to induce remissions in the Binet A high-risk CLL, our data do not provide evidence that alters the current standard of care ""watch and wait"" for these patients.",2020,"There was no significant overall survival benefit for high-risk patients receiving early FCR therapy (5-year OS 82.9% in Hi-FCR vs. 79.9% in Hi-W&W, p = 0.864).","['Two hundred and one patients with ≥2 risk features were classified as high-risk CLL', 'patients with stage Binet A high-risk chronic lymphocytic leukemia (CLL', 'Eight hundred patients with untreated-stage Binet A disease were enrolled as intent-to-treat population and assessed for four prognostic markers: lymphocyte doubling time <12 months, serum thymidine kinase >10\u2009U/L, unmutated IGHV genes, and unfavorable cytogenetics (del(11q)/del(17p)/trisomy 12', 'patients with an early-stage high-risk chronic lymphocytic leukemia (CLL']","['immediate therapy with 6xFCR', 'fludarabine, cyclophosphamide, and rituximab (FCR', 'FCR']","['hematological toxicities and infections', 'overall survival benefit', 'overall response rate', 'event-free survival']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040078', 'cui_str': 'Deoxythymidine Kinase'}, {'cui': 'C0439339', 'cui_str': 'mU/mL'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetic'}, {'cui': 'C0432408', 'cui_str': 'Trisomy 12 (disorder)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",800.0,0.142644,"There was no significant overall survival benefit for high-risk patients receiving early FCR therapy (5-year OS 82.9% in Hi-FCR vs. 79.9% in Hi-W&W, p = 0.864).","[{'ForeName': 'Carmen D', 'Initials': 'CD', 'LastName': 'Herling', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany. carmen.herling@uk-koeln.de.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Cymbalista', 'Affiliation': ""Hopital Avicenne, Assistance Publique-Hopitaux de Paris (AP-HP), Service d'Hematologie Biologique, Bobigny, France.""}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Groß-Ophoff-Müller', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Bahlo', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Robrecht', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Langerbeins', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Fink', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Othman', 'Initials': 'O', 'LastName': 'Al-Sawaf', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Raymonde', 'Initials': 'R', 'LastName': 'Busch', 'Affiliation': 'Institute for Medical Statistics and Epidemiology, Technical University, Munich, Germany.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Porcher', 'Affiliation': 'Center of Clinical Epidemiology, Hopital Hotel-Dieu, Paris, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Cazin', 'Affiliation': 'Service de Maladies du Sang, CHU Claude Huriez, Lille Cedex, France.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Dreyfus', 'Affiliation': ""Service d'Hematologie, CHU Poitiers, Poitiers, France.""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ibach', 'Affiliation': 'WiSP Wissenschaftlicher Service Pharma GmbH, Langenfeld, Germany.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Leprêtre', 'Affiliation': 'Inserm Unit U1245 and Department of Hematology, Cancer Centre Henri Becquerel and Normandie University Rouen, Rouen, France.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Kaiser', 'Affiliation': 'Day Clinic Hematology Oncology Palliative Care, Landshut, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Eichhorst', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Clemens-Martin', 'Initials': 'CM', 'LastName': 'Wentner', 'Affiliation': 'Department of Hematology Oncology, Immunology, Palliative Medicine, Infectious Diseases and Tropical Medicine, Klinikum Schwabing, Munich, Germany.'}, {'ForeName': 'Manuela A', 'Initials': 'MA', 'LastName': 'Hoechstetter', 'Affiliation': 'Department of Hematology Oncology, Immunology, Palliative Medicine, Infectious Diseases and Tropical Medicine, Klinikum Schwabing, Munich, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Leblond', 'Affiliation': 'Department of Haematology, Hopital de la Pitie-Salpetriere, Paris, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kneba', 'Affiliation': 'Second Department of Medicine, University of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Remi', 'Initials': 'R', 'LastName': 'Letestu', 'Affiliation': ""Hopital Avicenne, Assistance Publique-Hopitaux de Paris (AP-HP), Service d'Hematologie Biologique, Bobigny, France.""}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Böttcher', 'Affiliation': 'Second Department of Medicine, University of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Levy', 'Affiliation': 'Unite de Recherche Clinique, Hopital Avicenne, Bobigny, France.'}]",Leukemia,['10.1038/s41375-020-0747-7']
2720,32072617,Effect of 6% hydroxyethyl starch 130/0.4 on kidney and haemostatic function in cardiac surgical patients: a randomised controlled trial.,"Whether third-generation hydroxyethyl starch solutions provoke kidney injury or haemostatic abnormalities in patients having cardiac surgery remains unclear. We tested the hypotheses that intra-operative administration of a third-generation starch does not worsen postoperative kidney function or haemostasis in cardiac surgical patients compared with human albumin 5%. This triple-blind, non-inferiority, clinical trial randomly allocated patients aged 40-85 who underwent elective aortic valve replacement, with or without coronary artery bypass grafting, to plasma volume replacement with 6% starch 130/0.4 vs. 5% human albumin. Our primary outcome was postoperative urinary neutrophil gelatinase-associated lipocalin concentrations, a sensitive and early marker of postoperative kidney injury. Secondarily, we evaluated urinary interleukin-18; acute kidney injury using creatinine RIFLE criteria, coagulation measures, platelet count and function. Non-inferiority (delta 15%) was assessed with correction for multiple comparisons. We enrolled 141 patients (69 starch, 72 albumin) as planned. Results of the primary analysis demonstrated that postoperative urine neutrophil gelatinase-associated lipocalin (median (IQR [range])) was slightly lower with hydroxyethyl starch (5 (1-68 [0-996]) ng.ml -1  ) vs. albumin (5 (2-74 [0-1604]) ng.ml -1  ), although not non-inferior [ratio of geometric means (95%CI) 0.91 (0.57, 1.44); p = 0.15] due to higher than expected variability. Urine interleukin-18 concentrations were reduced, but interleukin-18 and kidney injury were again not non-inferior. Of 11 individual coagulation measures, platelet count and function, nine were non-inferior to albumin. Two remaining measures, thromboelastographic R value and arachidonic acid-induced platelet aggregation, were clinically similar but with wide confidence intervals. Starch administration during cardiac surgery produced similar observed effects on postoperative kidney function, coagulation, platelet count and platelet function compared with albumin, though greater than expected variability and wide confidence intervals precluded the conclusion of non-inferiority. Long-term mortality and kidney function appeared similar between starch and albumin.",2020,Whether third-generation hydroxyethyl starch solutions provoke kidney injury or haemostatic abnormalities in patients having cardiac surgery remains unclear.,"['patients aged 40-85 who underwent', 'patients having cardiac surgery', 'cardiac surgical patients', '141 patients (69 starch, 72 albumin) as planned']","['hydroxyethyl starch solutions', 'elective aortic valve replacement, with or without coronary artery bypass grafting, to plasma volume replacement with 6% starch 130/0.4 vs. 5% human albumin', 'hydroxyethyl starch']","['postoperative urinary neutrophil gelatinase-associated lipocalin concentrations, a sensitive and early marker of postoperative kidney injury', 'urinary interleukin-18; acute kidney injury using creatinine RIFLE criteria, coagulation measures, platelet count and function', 'Urine interleukin-18 concentrations', 'Long-term mortality and kidney function', 'postoperative kidney function or haemostasis', 'postoperative kidney function, coagulation, platelet count and platelet function', 'postoperative urine neutrophil gelatinase-associated lipocalin (median (IQR [range', 'thromboelastographic R value and arachidonic acid-induced platelet aggregation', 'kidney and haemostatic function', 'haemostatic abnormalities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0020352', 'cui_str': 'hydroxyethylstarch'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0032127', 'cui_str': 'Blood Plasma Volume'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0304925', 'cui_str': 'Albumin Human, USP'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0206528', 'cui_str': 'Gelatinases'}, {'cui': 'C1956074', 'cui_str': 'Lipocalins'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0035611', 'cui_str': 'Rifles'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0042037'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C1254881', 'cui_str': 'Platelet function'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1268820', 'cui_str': 'Arachidonic acid induced platelet aggregation'}, {'cui': 'C0019116', 'cui_str': 'Hemostasis'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]",141.0,0.397991,Whether third-generation hydroxyethyl starch solutions provoke kidney injury or haemostatic abnormalities in patients having cardiac surgery remains unclear.,"[{'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Duncan', 'Affiliation': 'Departments of Cardiothoracic Anesthesiology and Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Soltesz', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Leung', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'H O', 'Initials': 'HO', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Mao', 'Affiliation': 'Departments of Quantitative Health Sciences and Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Timur', 'Affiliation': 'Department of Laboratory Medicine, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kottke-Marchant', 'Affiliation': 'Department of Pathology and Laboratory Administration, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Rogers', 'Affiliation': 'Department of Laboratory Medicine, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Departments of Quantitative Health Sciences and Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ince', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Karimi', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yagar', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Trombetta', 'Affiliation': 'Department of Cardiothoracic Anesthesiology, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'D I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.'}]",Anaesthesia,['10.1111/anae.14994']
2721,32061571,The effects of silicone-based resilient denture liners on pain: A randomized controlled trial.,"PURPOSE


This randomized controlled trial aimed to study the effects of lining mandibular complete dentures with silicone-based resilient denture liners, especially with respect to sensation.
METHODS


The trial included completely edentulous patients who were willing to fabricate new set of complete denture. A random permuted block method (block size: 4) was used to assign participants to one of the following groups: mandibular conventional denture (CD) group or mandibular denture with resilient denture liner (RD) group. The outcomes were evaluated using both, objective measures (current perception threshold (CPT) and pain threshold (PT)) for external stimuli measured using the Neurometer CPT® and subjective measures (physical pain and psychological discomfort measured using the Japanese version of Oral Health Impact Profile for Edentulous patients-OHIP-EDENT-J). The outcomes were measured twice, at immediately after completion of denture adjustments (first measurement), and 3 months after the completion of denture adjustments (second measurement). All outcomes were analyzed using the Student t-test. A p-value of <0.05 was considered statistically significant.
RESULTS


CPT was significantly higher with RD than CD only at second measurement with frequency level of 2000 Hz and 5 Hz. The pain thresholds were significantly higher in the RD group than the CD group. The physical pain and psychological discomfort scores were significantly lower in the RD group than in the CD group.
CONCLUSION


This study concludes that edentulous patients wearing mandibular complete dentures with silicone-based resilient denture liners dull perception mandibular ridge mucosa and felt less pain than those without the liners.",2020,"The physical pain and psychological discomfort scores were significantly lower in the RD group than in the CD group.
","['edentulous patients wearing mandibular complete dentures with silicone-based resilient denture liners dull perception mandibular ridge mucosa and felt less pain than those without the liners', 'edentulous patients who were willing to fabricate new set of complete denture']","['mandibular conventional denture (CD) group or mandibular denture with resilient denture liner (RD', 'silicone-based resilient denture liners', 'lining mandibular complete dentures with silicone-based resilient denture liners']","['pain thresholds', 'physical pain and psychological discomfort scores', 'pain', 'objective measures (current perception threshold (CPT) and pain threshold (PT)) for external stimuli measured using the Neurometer CPT® and subjective measures (physical pain and psychological discomfort measured using the Japanese version of Oral Health Impact Profile']","[{'cui': 'C0026644', 'cui_str': 'Mouth, Toothless'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011455', 'cui_str': 'Denture, Complete'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0011450', 'cui_str': 'Cushion Liners'}, {'cui': 'C0443208', 'cui_str': 'Dull (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332243', 'cui_str': 'Ridging (qualifier value)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0181663', 'cui_str': 'Liner (physical object)'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}]","[{'cui': 'C0457285', 'cui_str': 'Conventional denture (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0011394', 'cui_str': 'Dentures'}, {'cui': 'C0011450', 'cui_str': 'Cushion Liners'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0011455', 'cui_str': 'Denture, Complete'}]","[{'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0029162'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",,0.0736263,"The physical pain and psychological discomfort scores were significantly lower in the RD group than in the CD group.
","[{'ForeName': 'So', 'Initials': 'S', 'LastName': 'Furokawa', 'Affiliation': 'Nihon University Graduate School of Dentistry at Matsudo, Removable Prosthodontics, Matsudo, Japan.'}, {'ForeName': 'Suguru', 'Initials': 'S', 'LastName': 'Kimoto', 'Affiliation': 'Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, Matsudo, 2-870-1 Sakaecho-nishi, Chiba 271-8587, Japan. Electronic address: kimoto.suguru@nihon-u.ac.jp.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Furuse', 'Affiliation': 'Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, Matsudo, 2-870-1 Sakaecho-nishi, Chiba 271-8587, Japan.'}, {'ForeName': 'Yoshiteru', 'Initials': 'Y', 'LastName': 'Furuya', 'Affiliation': 'Nihon University Graduate School of Dentistry at Matsudo, Removable Prosthodontics, Matsudo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Ogawa', 'Affiliation': 'Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, Matsudo, 2-870-1 Sakaecho-nishi, Chiba 271-8587, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Nakashima', 'Affiliation': 'Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, Matsudo, 2-870-1 Sakaecho-nishi, Chiba 271-8587, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Okubo', 'Affiliation': 'Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, Matsudo, 2-870-1 Sakaecho-nishi, Chiba 271-8587, Japan.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Anesthesiology, Nihon University School of Dentistry at Matsudo, Matsudo, Japan.'}, {'ForeName': 'Yasuhiko', 'Initials': 'Y', 'LastName': 'Kawai', 'Affiliation': 'Nihon University Graduate School of Dentistry at Matsudo, Removable Prosthodontics, Matsudo, Japan.'}]",Journal of prosthodontic research,['10.1016/j.jpor.2019.11.006']
2722,32061525,"The effect of training order on neuromuscular, endocrine and mood response to small-sided games and resistance training sessions over a 24-h period.","OBJECTIVES


This study examined the acute effect of small-sided-game (SSG) and resistance training sequence on neuromuscular, endocrine and mood response over a 24-h (h) period.
DESIGN


Repeated measures.
METHODS


Fourteen semi-professional soccer players performed SSG-training (4vs4+goalkeepers; 6×7-min, 2-min inter-set recovery) followed by resistance training 2h later (back-squat, Romanian deadlift, barbell-hip-thrust; 4×4 repetitions, 4-min inter-set recovery; 85% 1 rep-max) (SSG+RES), and on a separate week reversed the session order (RES+SSG). Physical demands of SSG's were monitored using global positioning systems (GPS) and ratings of perceived exertion (RPE). Countermovement-jump (CMJ; peak power output; jump height) and brief assessment of mood were collected before (pre), during (0h) and after (+24h) both protocols. Salivary testosterone and cortisol concentrations were obtained at the same time-points but with the inclusion of a measure immediately prior to the second training session (+2h).
RESULTS


GPS outputs and RPE were similar between SSG-training during both protocols. Between-protocol comparisons revealed no significant differences at +24h in CMJ performance, mood, and endocrine markers. Testosterone was higher at 0h during RES+SSG in comparison to SSG+RES (moderate-effect; +21.4±26.7pgml -1 ; p=0.010), yet was similar between protocols by +2h.
CONCLUSIONS


The order of SSG and resistance training does not appear to influence the physical demands of SSG's with sufficient recovery between two sessions performed on the same day. Session order did not influence neuromuscular, endocrine or mood responses at +24h, however a favourable testosterone response from the resistance first session may enhance neuromuscular performance in the second session of the day.",2020,The order of SSG and resistance training does not appear to influence the physical demands of SSG's with sufficient recovery between two sessions performed on the same day.,['Fourteen semi-professional soccer players performed'],"['small-sided-game (SSG) and resistance training sequence', 'SSG-training (4vs4+goalkeepers; 6×7-min, 2-min inter-set recovery) followed by resistance training 2h later (back-squat, Romanian deadlift, barbell-hip-thrust; 4×4 repetitions, 4-min inter-set recovery; 85% 1 rep-max) (SSG+RES), and on a separate week reversed the session order (RES+SSG']","['Salivary testosterone and cortisol concentrations', 'Testosterone', 'CMJ performance, mood, and endocrine markers', 'neuromuscular, endocrine and mood response', 'Countermovement-jump (CMJ; peak power output; jump height) and brief assessment of mood', 'neuromuscular performance']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C2919684', 'cui_str': 'Romanian'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C2237119', 'cui_str': 'Assessment of mood (procedure)'}]",,0.0184009,The order of SSG and resistance training does not appear to influence the physical demands of SSG's with sufficient recovery between two sessions performed on the same day.,"[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Sparkes', 'Affiliation': 'Applied Sports Technology Exercise and Medicine Research Centre (A-STEM), Health and Sport Portfolio, Swansea University, UK.'}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Turner', 'Affiliation': 'London Sports Institute, Science and Technology, Middlesex University, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Weston', 'Affiliation': 'Department of Psychology, Sport and Exercise, School of Social Sciences, Humanities and Law, Teesside University, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Russell', 'Affiliation': 'School of Social and Health Sciences, Leeds Trinity University, UK.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Johnston', 'Affiliation': 'British Athletics, University of Loughborough, UK.'}, {'ForeName': 'L P', 'Initials': 'LP', 'LastName': 'Kilduff', 'Affiliation': 'Applied Sports Technology Exercise and Medicine Research Centre (A-STEM), Health and Sport Portfolio, Swansea University, UK. Electronic address: l.kilduff@swansea.ac.uk.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.01.017']
2723,32067628,Malaria Parasitemia and Nutritional Status during the Low Transmission Season in the Presence of Azithromycin Distribution among Preschool Children in Niger.,"The relationship between malaria and malnutrition is complicated, and existence of one may predispose or exacerbate the other. We evaluated the relationship between malaria parasitemia and nutritional status in children living in communities participating in a cluster-randomized trial of biannual azithromycin compared with placebo for prevention of childhood mortality. Data were collected during the low malaria transmission and low food insecurity season. Parasitemia was not associated with weight-for-height  Z -score (24 months:  P  = 0.11 azithromycin communities,  P  = 0.75 placebo communities), weight-for-age  Z -score (24 months:  P  = 0.83 azithromycin,  P  = 0.78 placebo), height-for-age  Z -score (24 months:  P  = 0.30 azithromycin,  P  = 0.87 placebo), or mid-upper arm circumference (24 months:  P  = 0.12 azithromycin,  P  = 0.56 placebo). There was no statistically significant evidence of a difference in the relationship in communities receiving azithromycin or placebo. During the low transmission season, there was no evidence that malaria parasitemia and impaired nutritional status co-occur in children.",2020,Parasitemia was not associated with weight-for-height  Z -score,"['children living in communities participating in a cluster-randomized trial of', 'Preschool Children in Niger']","['placebo', 'biannual azithromycin', 'azithromycin']","['Malaria Parasitemia and Nutritional Status', 'height-for-age  Z', 'weight-for-age  Z -score', 'Parasitemia', 'malaria parasitemia and nutritional status', 'childhood mortality', 'malaria parasitemia', 'score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0028074', 'cui_str': 'Republic of Niger'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0869806,Parasitemia was not associated with weight-for-height  Z -score,"[{'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Arzika', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Ramatou', 'Initials': 'R', 'LastName': 'Maliki', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Nameywa', 'Initials': 'N', 'LastName': 'Boubacar', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Salissou', 'Initials': 'S', 'LastName': 'Kane', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Cook', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lebas', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Kieran S', 'Initials': 'KS', 'LastName': ""O'Brien"", 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Austin', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': '', 'Initials': '', 'LastName': 'For The Mordor Study Group', 'Affiliation': ''}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0547']
2724,32060547,"When, How, & Where Tobacco Initiation and Relapse Occur During U.S. Air Force Technical Training.","INTRODUCTION


Military personnel are at high risk for tobacco use, particularly during the first year of military service. Technical Training follows an 8½ week tobacco ban during basic military training and is a vulnerable time for personnel to both reinitiate and initiate tobacco use. Thus, this can be a crucial time to promote tobacco policies and interventions. However, there is limited research examining when, how, and where personnel access tobacco during the first year of service, particularly among users of newer products (eg, electronic cigarettes[e-cigarettes]). Thus, the purpose of the current study is to explore the timing, source, and location of tobacco use during Technical Training across all types of products. Furthermore, this study will examine differences in demographic characteristics and prior tobacco history in relationship to these tobacco behaviors.
MATERIALS AND METHODS


Participants were U.S. Air Force recruits completing Technical Training (2017-2018). Protocol was approved by the Institutional Review Board at the 59th Medical Wing of the U.S. Air Force. During the first week of Technical Training, Airmen were consented to participate in the study and completed a questionnaire about demographics and tobacco use history. Next, Airmen were randomized to receive one of three tobacco prevention interventions as part of military training. At a 3-month follow-up, during the last week of Technical Training, consented participants completed a questionnaire about current tobacco use. Airmen reported when (ie, first month vs. after), how (ie, ""bummed"" from another airman, bought on or off base, received from the internet or event), and where (ie, designated smoking areas on base, off base, bar or club, friend's house, cigar lounge, hookah bar, or vape shop) they used tobacco during Technical Training. Descriptive statistics were used to examine these behaviors across all tobacco products. Additionally, Wilcoxon-Mann-Whitney and Kruskal-Wallis tests compared differences in demographic characteristics and baseline tobacco use in relationship to these tobacco behaviors.
RESULTS


No significant differences were found when comparing prior users and first-time users in relationship to tobacco behaviors during Technical Training; however, significant differences in educational background and age were found in regard to the source and location of tobacco use. Additionally, how and where Airmen first used tobacco during Technical Training differed across products. Cigarettes and smokeless tobacco were equally likely to be bought on or off base and most commonly first used at a designated smoking area on base. However, e-cigarettes, cigarillos/little cigars, and hookah were more likely to be bought off base, and first used at a specialty store (ie, vape shop, hookah bar, or cigar lounge).
CONCLUSIONS


Tobacco use behaviors during Technical Training differed depending on the type of product. Specifically, new and emerging products were more likely to be bought off base and first used at a specialty store. Thus, military polices regulating on base tobacco pricing might not reduce the growing prevalence of e-cigarettes. Future policies might consider addressing the density of off-base tobacco retailers to reduce the high rates of tobacco use in this population.",2020,"No significant differences were found when comparing prior users and first-time users in relationship to tobacco behaviors during Technical Training; however, significant differences in educational background and age were found in regard to the source and location of tobacco use.",['Participants were U.S. Air Force recruits completing Technical Training (2017-2018'],['tobacco prevention interventions as part of military training'],['Tobacco Initiation and Relapse Occur'],"[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",,0.0301639,"No significant differences were found when comparing prior users and first-time users in relationship to tobacco behaviors during Technical Training; however, significant differences in educational background and age were found in regard to the source and location of tobacco use.","[{'ForeName': 'Margaret Celice', 'Initials': 'MC', 'LastName': 'Fahey', 'Affiliation': 'Department of Psychology; 400 Innovation Drive, Memphis, TN 38111, USA.'}, {'ForeName': 'G Wayne', 'Initials': 'GW', 'LastName': 'Talcott', 'Affiliation': 'University of Virginia School of Medicine; Center for Addiction and Prevention Research; 560 Ray C. Hunt Drive, Charlottesville, VA 22908, USA.'}, {'ForeName': 'Timothy L', 'Initials': 'TL', 'LastName': 'McMurry', 'Affiliation': 'University of Virginia School of Medicine; Center for Addiction and Prevention Research; 560 Ray C. Hunt Drive, Charlottesville, VA 22908, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Klesges', 'Affiliation': 'University of Virginia School of Medicine; Center for Addiction and Prevention Research; 560 Ray C. Hunt Drive, Charlottesville, VA 22908, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tubman', 'Affiliation': 'University of Virginia School of Medicine; Center for Addiction and Prevention Research; 560 Ray C. Hunt Drive, Charlottesville, VA 22908, USA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Krukowski', 'Affiliation': 'University of Tennessee Health Science Center, Department of Preventive Medicine; 66 N Pauline Street Memphis, TN 38163, USA.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Little', 'Affiliation': 'University of Virginia School of Medicine; Center for Addiction and Prevention Research; 560 Ray C. Hunt Drive, Charlottesville, VA 22908, USA.'}]",Military medicine,['10.1093/milmed/usaa016']
2725,32044942,Effect of Incisional Negative Pressure Wound Therapy vs Standard Wound Dressing on Deep Surgical Site Infection After Surgery for Lower Limb Fractures Associated With Major Trauma: The WHIST Randomized Clinical Trial.,"Importance


Following surgery to treat major trauma-related fractures, deep wound infection rates are high. It is not known if negative pressure wound therapy can reduce infection rates in this setting.
Objective


To assess outcomes in patients who have incisions resulting from surgery for lower limb fractures related to major trauma and were treated with either incisional negative pressure wound therapy or standard wound dressing.
Design, Setting, and Participants


A randomized clinical trial conducted at 24 trauma hospitals representing the UK Major Trauma Network that included 1548 patients aged 16 years or older who underwent surgery for a lower limb fracture caused by major trauma from July 7, 2016, through April 17, 2018, with follow-up to December 11, 2018.
Interventions


Incisional negative pressure wound therapy (n = 785), which involved a specialized dressing used to create negative pressure over the wound, vs standard wound dressing not involving negative pressure (n = 763).
Main Outcomes and Measures


The primary outcome measure was deep surgical site infection at 30 days diagnosed according to the criteria from the US Centers for Disease Control and Prevention. A preplanned secondary analysis of the primary outcome was performed at 90 days. The secondary outcomes were patient-reported disability (Disability Rating Index), health-related quality of life (EuroQol 5-level EQ-5D), surgical scar assessment (Patient and Observer Scar Assessment Scale), and chronic pain (Douleur Neuropathique Questionnaire) at 3 and 6 months, as well as other local wound healing complications at 30 days.
Results


Among 1548 participants who were randomized (mean [SD] age, 49.8 [20.3] years; 561 [36%] were aged ≤40 years; 583 [38%] women; and 881 [57%] had multiple injuries), 1519 (98%) had data available for the primary outcome. At 30 days, deep surgical site infection occurred in 5.84% (45 of 770 patients) of the incisional negative pressure wound therapy group and in 6.68% (50 of 749 patients) of the standard wound dressing group (odds ratio, 0.87 [95% CI, 0.57 to 1.33]; absolute risk difference, -0.77% [95% CI, -3.19% to 1.66%]; P = .52). There was no significant difference in the deep surgical site infection rate at 90 days (11.4% [72 of 629 patients] in the incisional negative pressure wound therapy group vs 13.2% [78 of 590 patients] in the standard wound dressing group; odds ratio, 0.84 [95% CI, 0.59 to 1.19]; absolute risk difference, -1.76% [95% CI, -5.41% to 1.90%]; P = .32). For the 5 prespecified secondary outcomes reported, there were no significant differences at any time point.
Conclusions and Relevance


Among patients who underwent surgery for major trauma-related lower limb fractures, use of incisional negative pressure wound therapy, compared with standard wound dressing, resulted in no significant difference in the rate of deep surgical site infection. The findings do not support the use of incisional negative pressure wound therapy in this setting, although the event rate at 30 days was lower than expected.
Trial Registration


isrctn.org Identifier: ISRCTN12702354.",2020,"At 30 days, deep surgical site infection occurred in 5.84% (45 of 770 patients) of the incisional negative pressure wound therapy group and in 6.68% (50 of 749 patients) of the standard wound dressing group (odds ratio, 0.87 [95% CI, 0.57 to 1.33]; absolute risk difference, -0.77% [95% CI, -3.19% to 1.66%]; P = .52).","['1548 participants who were randomized (mean [SD] age, 49.8 [20.3] years; 561 [36%] were aged ≤40 years; 583 [38%] women; and 881 [57%] had multiple injuries), 1519 (98%) had data available for the primary outcome', 'patients who underwent surgery for major trauma-related lower limb fractures', 'Major Trauma', 'patients who have incisions resulting from surgery for lower limb fractures related to major trauma and were treated with either', 'Lower Limb Fractures', '24 trauma hospitals representing the UK Major Trauma Network that included 1548 patients aged 16 years or older who underwent surgery for a lower limb fracture caused by major trauma from July 7, 2016, through April 17, 2018, with follow-up to December 11, 2018']","['Incisional Negative Pressure Wound Therapy vs Standard Wound Dressing', 'incisional negative pressure wound therapy or standard wound dressing', 'Incisional negative pressure wound therapy (n\u2009=\u2009785), which involved a specialized dressing used to create negative pressure over the wound, vs standard wound dressing not involving negative pressure']","['patient-reported disability (Disability Rating Index), health-related quality of life (EuroQol 5-level EQ-5D), surgical scar assessment (Patient and Observer Scar Assessment Scale), and chronic pain (Douleur Neuropathique Questionnaire) at 3 and 6 months, as well as other local wound healing complications', 'Deep Surgical Site Infection', 'deep surgical site infection rate', 'infection rates', 'deep surgical site infection', 'rate of deep surgical site infection']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0026771', 'cui_str': 'Polytrauma'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1542178', 'cui_str': 'Fracture of lower leg'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178388', 'cui_str': 'Dressing of wound (procedure)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0205429', 'cui_str': 'Uninvolved (qualifier value)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0334150', 'cui_str': 'Surgical scar (morphologic abnormality)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",1548.0,0.156034,"At 30 days, deep surgical site infection occurred in 5.84% (45 of 770 patients) of the incisional negative pressure wound therapy group and in 6.68% (50 of 749 patients) of the standard wound dressing group (odds ratio, 0.87 [95% CI, 0.57 to 1.33]; absolute risk difference, -0.77% [95% CI, -3.19% to 1.66%]; P = .52).","[{'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Costa', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, England.'}, {'ForeName': 'Juul', 'Initials': 'J', 'LastName': 'Achten', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, England.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Knight', 'Affiliation': 'Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, England.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bruce', 'Affiliation': 'Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, England.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dutton', 'Affiliation': 'Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, England.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Madan', 'Affiliation': 'Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, England.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Dritsaki', 'Affiliation': 'Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, England.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Parsons', 'Affiliation': 'Statistics and Epidemiology Unit, Warwick Medical School, University of Warwick, Coventry, England.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Fernandez', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, England.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Grant', 'Affiliation': 'Nuneaton, England.'}, {'ForeName': 'Jagdeep', 'Initials': 'J', 'LastName': 'Nanchahal', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, England.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.0059']
2726,31356508,Physical Activity Is Higher in Patients with LVADs Compared to Chronic Heart Failure.,"PURPOSE


Left ventricular assist devices (LVADs) are associated with an increased aerobic capacity in patients with chronic heart failure (CHF). However, studies evaluating the impact of LVAD implantation on physical activity (PA) are lacking. The aim of this study was to compare daily PA levels in participants with LVADs with well-matched CHF participants.
METHODS


Sixteen participants with an LVAD (age: 59.1 ± 10.8 years) were case-matched to 16 participants with advanced CHF (age: 58.3 ± 8.7 years), who were listed or being considered for cardiac transplantation. Participants underwent a cardiopulmonary exercise test to determine peak oxygen consumption (V[Combining Dot Above]O2 peak). PA was monitored continuously for seven consecutive days with an Actiheart monitor.
RESULTS


V[Combining Dot Above]O2 peak in the CHF group (12.3 ± 3.5 ml·kg·min) was not significantly different to the LVAD group prior to LVAD implantation (10.4 ± 2.1 ml·kg·min), but was lower than in the LVAD group following implantation (15.8 ± 4.3 ml·kg·min; p < 0.05). PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001). LVAD participants spent more time performing moderate intensity PA than their CHF counterparts, 26 (24-40) [median (IQR)] vs. 12 (9-16) min/day; p < 0.001. PA was correlated with V[Combining Dot Above]O2 peak (r = 0.582; p = 0.001) across participants in the CHF and LVAD groups.
CONCLUSION


Higher levels of PA were observed in participants with LVAD compared with patients with advanced CHF. This may be due to a higher V[Combining Dot Above]O2 peak, resulting in an improved capacity to perform activities of daily living with less symptoms.",2019,PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001).,"['Sixteen participants with an LVAD (age: 59.1 ± 10.8 years) were case-matched to 16 participants with advanced CHF (age: 58.3 ± 8.7 years), who were listed or being considered for cardiac transplantation', 'patients with chronic heart failure (CHF', 'participants with LVADs with well-matched CHF participants']","['LVAD implantation', 'Left ventricular assist devices (LVADs', 'cardiopulmonary exercise test', 'LVAD']","['Dot Above]O2 peak', 'time performing moderate intensity PA', 'V[Combining Dot Above]O2 peak', 'PA', 'peak oxygen consumption (V[Combining Dot Above]O2 peak', 'Physical Activity', 'aerobic capacity', 'daily PA levels', 'Higher levels of PA']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}]","[{'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",16.0,0.0464878,PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001).,"[{'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Moreno-Suarez', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Liew', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Lawrence G', 'Initials': 'LG', 'LastName': 'Dembo', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Larbalestier', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Maiorana', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002104']
2727,32063531,Periodontal health in shortened dental arches: A 10-year RCT.,"PURPOSE


This analysis focused on periodontal health in shortened dental arches (SDAs).
METHODS


In a randomized controlled clinical trial, patients with missing molars in one jaw and at least one premolar and canine on both sides were eligible for participation. In the partial removable dental prosthesis (PRDP) group (n = 79), molars were replaced with a precision attachment retained PRDP. In the SDA group (n == 71), the SDA up to the second premolars was either left as is or restored with fixed dental prostheses. Outcome variables were vertical clinical attachment loss (CAL-V), pocket probing depth (PPD), bleeding on probing (BOP) and plaque index (PLI). For CAL-V and PPD, the changes at six measuring points per tooth were analyzed. For BOP and PLI, patient related rates were calculated for each point in time. Statistical methods included linear regression analyses.
RESULTS


In the intention-to-treat (ITT) analysis for CAL-V in the study jaw, the 10 year patient related mean changes were 0.66 mm in the PRDP group and -0.13 mm in the SDA group. The resulting mean patient related group difference of 0.79 mm (95% CI: 0.20 mm-1.38 mm) was significant (p = 0.01). There were no significant differences in the ITT analyses for PPD. For BOP and PLI, significant group differences with more favorable results for the SDA group were found.
CONCLUSIONS


In view of lacking substantial differences for CAL-V and PPD, the overall differences were considered of minor clinical relevance. The results add confirmatory evidence to the shortened dental arch concept and its clinical viability (controlled-trials.com ISRCTN97265367).",2020,The resulting mean patient related group difference of 0.79 mm (95% CI: 0.20 mm-1.38 mm) was significant (p = 0.01).,"['patients with missing molars in one jaw and at least one premolar and canine on both sides were eligible for participation', 'shortened dental arches']","['SDA', 'partial removable dental prosthesis (PRDP']","['vertical clinical attachment loss (CAL-V), pocket probing depth (PPD), bleeding on probing (BOP) and plaque index (PLI', 'Periodontal health', 'ITT analyses for PPD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C0011325', 'cui_str': 'Dental Arch'}]","[{'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0162686', 'cui_str': 'Dental Prosthesis'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}]",,0.100739,The resulting mean patient related group difference of 0.79 mm (95% CI: 0.20 mm-1.38 mm) was significant (p = 0.01).,"[{'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Walter', 'Affiliation': 'Department of Prosthetic Dentistry, Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Fetscherstraße 74, Dresden 01307, Germany. Electronic address: michael.walter@uniklinikum-dresden.de.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Dreyhaupt', 'Affiliation': 'Institute of Epidemiology and Medical Biometry, Ulm University, Schwabstraße 13, Ulm 89075, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Mundt', 'Affiliation': 'Department of Prosthodontics, Gerodontology and Biomaterials, Dental School, University of Greifswald, Rotgerberstr. 8, Greifswald 17487, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Kohal', 'Affiliation': 'Department of Prosthetic Dentistry, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Hugstetter Str. 55, Freiburg im Breisgau 79106, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Kern', 'Affiliation': 'Department of Prosthodontics, Propaedeutics and Dental Materials, School of Dentistry, Christian-Albrechts University, Christian-Albrechts-Platz 4, Kiel 24118, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Rauch', 'Affiliation': 'Department of Prosthodontics and Materials Science, University of Leipzig, Liebigstr. 18, Leipzig 04103, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Nothdurft', 'Affiliation': 'Department of Prosthetic Dentistry and Dental Materials Science, Medical Center, Dental School and Clinics, Saarland University, Campus Homburg, Kirrberger Str. 100, Homburg/Saar 66421, Germany.'}, {'ForeName': 'Sinsa', 'Initials': 'S', 'LastName': 'Hartmann', 'Affiliation': 'Department of Prosthetic Dentistry, Johannes-Gutenberg University of Mainz, Langenbeckstr. 1, Mainz 55131, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Böning', 'Affiliation': 'Department of Prosthetic Dentistry, Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Fetscherstraße 74, Dresden 01307, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Boldt', 'Affiliation': 'Department of Prosthetic Dentistry, Julius-Maximilians University of Würzburg, Pleicherwall 2, Würzburg 97070, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Stark', 'Affiliation': 'Department of Prosthodontics, Preclinical Education and dental Materials Science, University of Bonn, Welschnonnenstr.17, Bonn 53111, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Edelhoff', 'Affiliation': 'Department of Prosthetic Dentistry, University Hospital, LMU Ludwig-Maximilians-University, Goethestraße 70, Munich 80336, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Wöstmann', 'Affiliation': 'Department of Prosthetic Dentistry, Justus-Liebig University of Gießen, Rudolf-Buchheim-Str. 8, Gießen 35392, Germany.'}, {'ForeName': 'Ralph Gunnar', 'Initials': 'RG', 'LastName': 'Luthardt', 'Affiliation': 'Department of Prosthetic Dentistry, Center of Dentistry, Universitätsklinikum Ulm, Albert-Einstein-Allee 11, Ulm 89081, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hannak', 'Affiliation': 'Charité - Universitätsmedizin Berlin, CC3 - Charité, Center for Dental and Craniofacial Sciences, Department of Prosthodontics, Geriatic Dentistry and Craniomandibular Disorders, Campus Benjamin Franklin, Aßmannshauser Straße 4-6, Berlin 14197, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wolfart', 'Affiliation': 'Department of Prosthodontics and Biomaterials, Medical Faculty, RWTH Aachen University, Pauwelsstr. 30, Aachen 52074, Germany.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Heydecke', 'Affiliation': 'Department of Prosthodontics, University Medical Center Eppendorf, Zahnärztliche Prothetik, Martinistr. 52, Hamburg 20246, Germany.'}, {'ForeName': 'Florentine', 'Initials': 'F', 'LastName': 'Jahn', 'Affiliation': 'Department of Prosthetic Dentistry and Dental Material Science, Friedrich-Schiller University of Jena, Poliklinik für Zahnärztliche Prothetik und Werkstoffkunde, An der Alten Post 4, Jena 07743, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Pospiech', 'Affiliation': 'Vogelweidestr. 5, 97230 Estenfeld, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Marré', 'Affiliation': 'Department of Prosthetic Dentistry, Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Fetscherstraße 74, Dresden 01307, Germany.'}]",Journal of prosthodontic research,['10.1016/j.jpor.2020.01.005']
2728,32063509,"The influence of baseball pitching distance on pitching biomechanics, pitch velocity, and ball movement.","OBJECTIVES


To determine whether increasing pitching distance for adult baseball pitchers would affect their upper extremity kinetics, full-body kinematics, and pitched ball kinematics (ball velocity, duration of ball flight, vertical and horizontal break, strike percentage).
DESIGN


Controlled laboratory study.
METHODS


Twenty-six collegiate baseball pitchers threw sets of five full-effort fastballs from three different pitching distances (18.44m, 19.05m, 19.41m) in a randomized order. Ball velocity, horizontal and vertical break, duration of ball flight, and strike percentage were computed by a ball tracking system, while pitching kinetics and kinematics were calculated with a 12-camera optical motion capture system. Repeated measures analysis of variance was utilized to detect significant differences among the three different pitching distances (p<0.05).
RESULTS


No significant differences in pitching kinetics and kinematics were observed among the varying pitching distances. Ball velocity and strike percentage were also not significantly different among the pitching distances, however, the duration of ball flight and horizontal and vertical break significantly increased with pitching distance.
CONCLUSIONS


Increasing pitching distance may not alter upper extremity kinetics, full-body kinematics, ball velocity or strike percentage in adult pitchers. However, as pitching distance increases the duration of ball flight and amount of horizontal and vertical break also increase. Increased ball flight duration could be an advantage for the hitter while increased ball break could help the pitcher. In conclusion, it is unlikely that moving the mound backwards would significantly affect pitching biomechanics and injury risk; however, the effects on pitching and hitting performance are unknown.",2020,"Ball velocity and strike percentage were also not significantly different among the pitching distances, however, the duration of ball flight and horizontal and vertical break significantly increased with pitching distance.
","['Twenty-six collegiate baseball pitchers threw sets of five full-effort fastballs from three different pitching distances (18.44m, 19.05m, 19.41m) in a randomized order']",[],"['pitching kinetics and kinematics', 'duration of ball flight and horizontal and vertical break significantly increased with pitching distance', 'upper extremity kinetics, full-body kinematics, ball velocity or strike percentage', 'pitching biomechanics, pitch velocity, and ball movement', 'upper extremity kinetics, full-body kinematics, and pitched ball kinematics (ball velocity, duration of ball flight, vertical and horizontal break, strike percentage', 'Ball velocity, horizontal and vertical break, duration of ball flight, and strike percentage', 'duration of ball flight and amount of horizontal and vertical break', 'Ball velocity and strike percentage', 'Increased ball flight duration']","[{'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0004795', 'cui_str': 'Baseball'}, {'cui': 'C0560512', 'cui_str': 'Does throw (finding)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}]",[],"[{'cui': 'C0175681', 'cui_str': 'Pitch (observable entity)'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439790', 'cui_str': 'Horizontal and vertical (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0038452', 'cui_str': 'Strikes'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}]",26.0,0.0231832,"Ball velocity and strike percentage were also not significantly different among the pitching distances, however, the duration of ball flight and horizontal and vertical break significantly increased with pitching distance.
","[{'ForeName': 'Alek Z', 'Initials': 'AZ', 'LastName': 'Diffendaffer', 'Affiliation': 'American Sports Medicine Institute, United States. Electronic address: AlekD@asmi.org.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Slowik', 'Affiliation': 'American Sports Medicine Institute, United States.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hart', 'Affiliation': 'American Sports Medicine Institute, United States.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Andrews', 'Affiliation': 'American Sports Medicine Institute, United States.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Dugas', 'Affiliation': 'American Sports Medicine Institute, United States.'}, {'ForeName': 'E Lyle', 'Initials': 'EL', 'LastName': 'Cain', 'Affiliation': 'American Sports Medicine Institute, United States.'}, {'ForeName': 'Glenn S', 'Initials': 'GS', 'LastName': 'Fleisig', 'Affiliation': 'American Sports Medicine Institute, United States.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.02.005']
2729,31686559,"A matching-adjusted indirect treatment comparison (MAIC) of daratumumab-bortezomib-melphalan-prednisone (D-VMP) versus lenalidomide-dexamethasone continuous (Rd continuous), lenalidomide-dexamethasone 18 months (Rd 18), and melphalan-prednisone-thalidomide (MPT).","D-VMP is a novel treatment for transplant-ineligible newly diagnosed multiple myeloma (TIE NDMM). D-VMP significantly prolonged PFS versus VMP in the ALCYONE trial. The FIRST trial investigated Rd given in 28-day cycles until disease progression, Rd for 18 cycles, and MPT for 12 cycles for TIE NDMM. As no randomized controlled trials comparing D-VMP to standard-of-care regimens such as those in FIRST are available, an MAIC was performed to assess relative OS and PFS for D-VMP from ALYCONE and Rd continuous, Rd 18, and MPT from FIRST. Individual patient data for D-VMP in ALCYONE were weighted to match aggregated baseline patient characteristics for each arm of FIRST. D-VMP significantly improved OS versus MPT and Rd 18, with a trend favoring D-VMP versus Rd continuous. D-VMP performed significantly better than all FIRST comparators for PFS. This MAIC demonstrates OS and PFS benefits for D-VMP versus Rd continuous, Rd 18, and MPT.",2020,"D-VMP significantly improved OS versus MPT and Rd 18, with a trend favoring D-VMP versus Rd continuous.",['transplant-ineligible newly diagnosed multiple myeloma (TIE NDMM'],"['melphalan-prednisone-thalidomide (MPT', 'daratumumab-bortezomib-melphalan-prednisone (D-VMP) versus lenalidomide-dexamethasone continuous (Rd continuous), lenalidomide-dexamethasone 18 months ', 'D-VMP']",[],"[{'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}]","[{'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",[],,0.0502985,"D-VMP significantly improved OS versus MPT and Rd 18, with a trend favoring D-VMP versus Rd continuous.","[{'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, ""Seragnoli"" Institute of Hematology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Maria-Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'Department of Hematology, University Hospital of Salamanca/IBSAL, Salamanca, Spain.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Facon', 'Affiliation': 'Department of Hematology, University of Lille, CHU Lille, Service des Maladies du Sang, Lille, France.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Heeg', 'Affiliation': 'Ingress Health, Rotterdam, The Netherlands.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'van Beekhuizen', 'Affiliation': 'Ingress Health, Rotterdam, The Netherlands.'}, {'ForeName': 'Samron B', 'Initials': 'SB', 'LastName': 'Gebregergish', 'Affiliation': 'Ingress Health, Rotterdam, The Netherlands.'}, {'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Nair', 'Affiliation': 'Janssen Research and Development, Beerse, Belgium.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Pisini', 'Affiliation': 'Janssen, EMEA, Beerse, Belgium.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Lam', 'Affiliation': 'Janssen Global Services, Raritan, NJ, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Slavcev', 'Affiliation': 'Janssen Global Services, Raritan, NJ, USA.'}]",Leukemia & lymphoma,['10.1080/10428194.2019.1682571']
2730,32058077,Taking time to take perspective? Rapidly changing reference frames in the avatar-Simon task.,"The avatar-Simon task demonstrates that even task irrelevant avatars cause compatibility effects from their point of view, a result that can be interpreted within the frameworks of spontaneous spatial perspective taking and referential coding. In the present study, we used an avatar-Simon task with rapidly changing avatar positions and with simultaneous and non-simultaneous presentations to investigate the time course of this phenomenon. The results showed that participants took the avatar's perspective into account even when the avatar's position was randomized on a trial-by-trial basis. This avatar-compatibility effect was also observed when avatar and stimulus were presented simultaneously, even though the participants had no time to adopt the avatar's perspective in advance. However, the effect was much more pronounced when a delay between avatar and stimulus presentation was in place.",2020,"The avatar-Simon task demonstrates that even task irrelevant avatars cause compatibility effects from their point of view, a result that can be interpreted within the frameworks of spontaneous spatial perspective taking and referential coding.",[],['avatar-Simon task with rapidly changing avatar positions and with simultaneous and non-simultaneous presentations'],['avatar-compatibility effect'],[],"[{'cui': 'C0443058', 'cui_str': 'Simon (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.0213115,"The avatar-Simon task demonstrates that even task irrelevant avatars cause compatibility effects from their point of view, a result that can be interpreted within the frameworks of spontaneous spatial perspective taking and referential coding.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Böffel', 'Affiliation': 'Institute of Psychology, RWTH Aachen University, Jägerstr. 17-19, 52056 Aachen, Germany. Electronic address: boeffel@psych.rwth-aachen.de.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Müsseler', 'Affiliation': 'Institute of Psychology, RWTH Aachen University, Jägerstr. 17-19, 52056 Aachen, Germany.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103005']
2731,31832227,A feasibility study of 'The StepSmart Challenge' to promote physical activity in adolescents.,"Background


Inactive lifestyles are becoming the norm and creative approaches to encourage adolescents to be more physically active are needed. Little is known about how gamification techniques can be used in physical activity interventions for young people. Such approaches may stimulate interest and encourage physical activity behaviour. The study investigated the feasibility of implementing and evaluating a physical activity intervention for adolescents which included gamification techniques within schools. We tested recruitment and retention strategies for schools and participants, the use of proposed outcome measures, and explored intervention acceptability.
Methods


This school-based feasibility study of a randomised cluster trial recruited adolescents aged 12-14 years ( n  = 224) from five schools (three intervention; two control) in Belfast, Northern Ireland. The 22-week intervention (The StepSmart Challenge) informed by self-determination theory and incorporating gamification strategies involved a school-based pedometer competition. Outcomes, measured at baseline, and post-intervention (at 22 weeks post-baseline and 52 weeks post-baseline) included daily minutes of moderate to vigorous physical activity (MVPA) (measured using ActiGraph accelerometer), mental wellbeing (Warwick-Edinburgh Mental Wellbeing Scale), social support for physical activity, time preference (for delayed and larger rewards or immediate and smaller rewards), pro-social behaviour (Strengths and Difficulties Questionnaire (SDQ)) and the influence of social networks. The intervention's acceptability was explored in focus groups.
Results


We invited 14 schools to participate; eight showed interest in participating. We recruited the first five who responded; all five completed the trial. Of the 236 pupils invited, 224 participated (94.9%): 84.8% (190/224) provided valid MVPA (minutes/day) at baseline and 57.2% (123/215) at 52 weeks. All other outcomes were well completed apart from the SDQ (65% at baseline). Qualitative data highlighted that participants and teachers found The StepSmart Challenge to be an acceptable intervention.
Conclusions


The level of interest and high recruitment and retention rates provide support for the feasibility of this trial. The intervention, incorporating gamification strategies and the recruitment methods, using parental opt-out procedures, were acceptable to participants and teachers. Teachers also suggested that the implementation of The StepSmart Challenge could be embedded in a lifelong learning approach to health within the school curriculum. As young people's lives become more intertwined with technology, the use of innovative gamified interventions could be one approach to engage and motivate health behavioural change in this population.
Trial registration


NCT02455986 (date of registration: 28 May 2015).",2019,"The intervention, incorporating gamification strategies and the recruitment methods, using parental opt-out procedures, were acceptable to participants and teachers.","['236 pupils invited, 224 participated (94.9%): 84.8% (190/224) provided', 'adolescents', 'adolescents which included gamification techniques within schools', 'adolescents aged 12-14\u2009years ( n \u2009=\u2009224) from five schools (three intervention; two control) in Belfast, Northern Ireland', 'young people']","['physical activity intervention', 'valid MVPA']","['daily minutes of moderate to vigorous physical activity (MVPA) (measured using ActiGraph accelerometer), mental wellbeing (Warwick-Edinburgh Mental Wellbeing Scale), social support for physical activity, time preference (for delayed and larger rewards or immediate and smaller rewards), pro-social behaviour (Strengths and Difficulties Questionnaire (SDQ)) and the influence of social networks']","[{'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0037438'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0037397', 'cui_str': 'Social Behavior'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire (assessment scale)'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]",,0.0483572,"The intervention, incorporating gamification strategies and the recruitment methods, using parental opt-out procedures, were acceptable to participants and teachers.","[{'ForeName': 'Rekesh', 'Initials': 'R', 'LastName': 'Corepal', 'Affiliation': ""UKCRC Centre of Excellence for Public Health/Centre for Public Health, Queen's University Belfast, Institute of Clinical Science B, Royal Victoria Hospital, Grosvenor Road, Belfast, BT12 6BA Northern Ireland.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Best', 'Affiliation': ""2Centre for Evidence and Social Innovation, School of Social Sciences, Education and Social Work, Queen's University Belfast, 6 College Park, 69-71 University Street, BT7 1NN Belfast, Northern Ireland.""}, {'ForeName': 'Roisin', 'Initials': 'R', 'LastName': ""O'Neill"", 'Affiliation': ""UKCRC Centre of Excellence for Public Health/Centre for Public Health, Queen's University Belfast, Institute of Clinical Science B, Royal Victoria Hospital, Grosvenor Road, Belfast, BT12 6BA Northern Ireland.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kee', 'Affiliation': ""UKCRC Centre of Excellence for Public Health/Centre for Public Health, Queen's University Belfast, Institute of Clinical Science B, Royal Victoria Hospital, Grosvenor Road, Belfast, BT12 6BA Northern Ireland.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Badham', 'Affiliation': ""UKCRC Centre of Excellence for Public Health/Centre for Public Health, Queen's University Belfast, Institute of Clinical Science B, Royal Victoria Hospital, Grosvenor Road, Belfast, BT12 6BA Northern Ireland.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dunne', 'Affiliation': ""2Centre for Evidence and Social Innovation, School of Social Sciences, Education and Social Work, Queen's University Belfast, 6 College Park, 69-71 University Street, BT7 1NN Belfast, Northern Ireland.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Miller', 'Affiliation': ""2Centre for Evidence and Social Innovation, School of Social Sciences, Education and Social Work, Queen's University Belfast, 6 College Park, 69-71 University Street, BT7 1NN Belfast, Northern Ireland.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Connolly', 'Affiliation': ""2Centre for Evidence and Social Innovation, School of Social Sciences, Education and Social Work, Queen's University Belfast, 6 College Park, 69-71 University Street, BT7 1NN Belfast, Northern Ireland.""}, {'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Cupples', 'Affiliation': ""UKCRC Centre of Excellence for Public Health/Centre for Public Health, Queen's University Belfast, Institute of Clinical Science B, Royal Victoria Hospital, Grosvenor Road, Belfast, BT12 6BA Northern Ireland.""}, {'ForeName': 'Esther M F', 'Initials': 'EMF', 'LastName': 'van Sluijs', 'Affiliation': '3MRC Epidemiology Unit & Centre for Diet and Activity Research (CEDAR), Institute of Metabolic Science, University of Cambridge School of Clinical Medicine, Box 285, Cambridge Biomedical Campus, CB2 0QQ Cambridge, UK.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Tully', 'Affiliation': '4Institute of Mental Health Sciences, School of Health Sciences, Ulster University, Newtownabbey, BT37 0QB Northern Ireland.'}, {'ForeName': 'Ruth F', 'Initials': 'RF', 'LastName': 'Hunter', 'Affiliation': ""UKCRC Centre of Excellence for Public Health/Centre for Public Health, Queen's University Belfast, Institute of Clinical Science B, Royal Victoria Hospital, Grosvenor Road, Belfast, BT12 6BA Northern Ireland.""}]",Pilot and feasibility studies,['10.1186/s40814-019-0523-5']
2732,32062791,Phase 3 Multicenter Study of Revusiran in Patients with Hereditary Transthyretin-Mediated (hATTR) Amyloidosis with Cardiomyopathy (ENDEAVOUR).,"PURPOSE


The Phase 3 ENDEAVOUR study evaluated revusiran, an investigational RNA interference therapeutic targeting hepatic transthyretin (TTR) production, for treating cardiomyopathy caused by hereditary transthyretin-mediated (hATTR) amyloidosis.
METHODS


Patients with hATTR amyloidosis with cardiomyopathy were randomized 2:1 to receive subcutaneous daily revusiran 500 mg (n = 140) or placebo (n = 66) for 5 days over a week followed by weekly doses. Co-primary endpoints were 6-min walk test distance and serum TTR reduction.
RESULTS


Revusiran treatment was stopped after a median of 6.71 months; the study Sponsor prematurely discontinued dosing due to an observed mortality imbalance between treatment arms. Eighteen (12.9%) patients on revusiran and 2 (3.0%) on placebo died during the on-treatment period. Most deaths in both treatment arms were adjudicated as cardiovascular due to heart failure (HF), consistent with the natural history of the disease. A post hoc safety investigation of patients treated with revusiran found that, at baseline, a greater proportion of those who died were ≥ 75 years and showed clinical evidence of more advanced HF compared with those who were alive throughout treatment. Revusiran pharmacokinetic exposures and TTR lowering did not show meaningful differences between patients who died and who were alive. Revusiran did not deleteriously affect echocardiographic parameters, cardiac biomarkers, or frequency of cardiovascular and HF hospitalization events.
CONCLUSIONS


Causes for the observed mortality imbalance associated with revusiran were thoroughly investigated and no clear causative mechanism could be identified. Although the results suggest similar progression of cardiac parameters in both treatment arms, a role for revusiran cannot be excluded.
CLINICAL TRIAL REGISTRATION


NCT02319005.",2020,"Revusiran did not deleteriously affect echocardiographic parameters, cardiac biomarkers, or frequency of cardiovascular and HF hospitalization events.
","['Patients with hATTR amyloidosis with cardiomyopathy', 'Patients with Hereditary Transthyretin-Mediated (hATTR) Amyloidosis with Cardiomyopathy (ENDEAVOUR']","['Revusiran', 'subcutaneous daily revusiran 500\xa0mg (n\u2009=\u2009140) or placebo']","['6-min walk test distance and serum TTR reduction', 'echocardiographic parameters, cardiac biomarkers, or frequency of cardiovascular and HF hospitalization events', 'mortality imbalance', 'Revusiran pharmacokinetic exposures and TTR lowering']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002726', 'cui_str': 'Amyloidosis'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0439660', 'cui_str': 'Hereditary (qualifier value)'}, {'cui': 'C0032923', 'cui_str': 'Transthyretin'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}]","[{'cui': 'C4505592', 'cui_str': 'revusiran'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C4505592', 'cui_str': 'revusiran'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",,0.0976805,"Revusiran did not deleteriously affect echocardiographic parameters, cardiac biomarkers, or frequency of cardiovascular and HF hospitalization events.
","[{'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Judge', 'Affiliation': 'Johns Hopkins Hospital, Baltimore, MD, USA.'}, {'ForeName': 'Arnt V', 'Initials': 'AV', 'LastName': 'Kristen', 'Affiliation': 'Department of Cardiology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Grogan', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Mathew S', 'Initials': 'MS', 'LastName': 'Maurer', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Rodney H', 'Initials': 'RH', 'LastName': 'Falk', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Mazen', 'Initials': 'M', 'LastName': 'Hanna', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Gillmore', 'Affiliation': 'National Amyloidosis Centre, Division of Medicine, UCL Medical School Royal Free Hospital Rowland Hill Street, NW3 2PF, London, UK.'}, {'ForeName': 'Pushkal', 'Initials': 'P', 'LastName': 'Garg', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Akshay K', 'Initials': 'AK', 'LastName': 'Vaishnaw', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Harrop', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Powell', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Karsten', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Marianne T', 'Initials': 'MT', 'LastName': 'Sweetser', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vest', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Hawkins', 'Affiliation': 'National Amyloidosis Centre, Division of Medicine, UCL Medical School Royal Free Hospital Rowland Hill Street, NW3 2PF, London, UK. p.hawkins@ucl.ac.uk.'}]",Cardiovascular drugs and therapy,['10.1007/s10557-019-06919-4']
2733,32039934,Secondary Analysis of Pain Outcomes in a Large Pragmatic Randomized Trial of Buprenorphine/Naloxone Versus Methadone for Opioid Use Disorder.,"OBJECTIVE


Opioid use disorder (OUD) is associated with chronic pain. We investigated the association between medication treatments for OUD and pain in a post-hoc secondary analysis of a randomized trial of methadone versus buprenorphine/naloxone.
METHODS


1241 individuals with OUD participated in an open label, pragmatic randomized trial of methadone versus buprenorphine/naloxone in nine treatment programs licensed to dispense agonist medication for OUD between 2006 to 2009. In this post-hoc analysis, pain was dichotomized (present or not present) using responses from the Short Form-36. Logistic regression models were fit to test the effect of (1) having baseline pain on week 24 retention, (2) treatment assignment on improvement in pain among those reporting pain at baseline, and (3) pain improvement at week 4 on week 24 retention among those reporting pain at baseline.
RESULTS


Almost half (48.2%) of the sample reported pain at baseline. Participants with baseline pain did not significantly differ in week 24 retention compared to those without baseline pain. Among those reporting pain at baseline, there was no significant difference between treatment arms in improvement of pain at week 4, but improvement in pain at week 4 was associated with significantly greater odds of being retained at week 24 (OR [95% CI] = 1.76 [1.10, 2.82], P = 0.020).
CONCLUSION AND RELEVANCE


In this large multisite randomized trial of medication treatments for OUD, nearly half of the participants reported pain at baseline, and improvement in pain early in treatment was associated with increased likelihood of retention in treatment.",2020,"Among those reporting pain at baseline, there was no significant difference between treatment arms in improvement of pain at week 4, but improvement in pain at week 4 was associated with significantly greater odds of being retained at week 24 (OR [95% CI] = 1.76","['in nine treatment programs licensed to dispense agonist medication for OUD between 2006 to 2009', '1241 individuals with OUD participated in an open label, pragmatic randomized trial of']","['methadone', 'Methadone', 'methadone versus buprenorphine/naloxone', 'buprenorphine/naloxone', 'Buprenorphine/Naloxone']","['pain', 'pain improvement', 'Pain Outcomes', 'baseline pain']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0023636', 'cui_str': 'Permits'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine / Naloxone'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",1241.0,0.257531,"Among those reporting pain at baseline, there was no significant difference between treatment arms in improvement of pain at week 4, but improvement in pain at week 4 was associated with significantly greater odds of being retained at week 24 (OR [95% CI] = 1.76","[{'ForeName': 'Matisyahu', 'Initials': 'M', 'LastName': 'Shulman', 'Affiliation': 'New York State Psychiatric Institute, New York, NY, (MS, SL, ANCC, JS, AB, EVN); Department of Psychiatry, Columbia University Medical Center, New York, NY, (MS, SL, ANCC, JS, EVN); Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY, (MP); Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine; Center of Excellence in Substance Abuse Treatment and Education VA Puget Sound Health Care System, WA (AJS).'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': ''}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Scodes', 'Affiliation': ''}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': ''}, {'ForeName': 'Andi', 'Initials': 'A', 'LastName': 'Broffman', 'Affiliation': ''}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Saxon', 'Affiliation': ''}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': ''}]",Journal of addiction medicine,['10.1097/ADM.0000000000000630']
2734,32050042,Absolute and relative differential blood count predicts survival of AJCC stage I-II melanoma patients scheduled for sentinel lymph node biopsy.,"BACKGROUND/OBJECTIVES


Elevated neutrophil-to-lymphocyte ratio (NLR) in peripheral blood is associated with poor overall survival (OS) in metastatic melanoma patients receiving immunotherapy. However, the impact of peripheral blood cells in patients undergoing sentinel lymph node biopsy (SLNB) is still unclear. This study was intended to characterize the impact of peripheral blood leukocytic cells on overall survival (OS) in melanoma patients undergoing SLNB.
METHODS


A total of 1412 AJCC stage I-II melanoma patients scheduled for SLNB at a single institution in the period 2010-2015 with available perioperative blood tests were randomly assigned to two independent cohorts. Associations of peripheral blood leukocytes with OS were analysed using Kaplan-Meier estimator and multivariate Cox proportional hazards model.
RESULTS


NLR >4.26, absolute neutrophil count >5800/µL, relative neutrophil count >69.7% and relative lymphocyte count ≤ 17.5% were significantly associated with reduced OS in both cohorts. Absolute monocytes >810/µL, absolute eosinophils ≤200/µL, relative monocytes >6.6%, relative eosinophils ≤2.7% and relative basophils ≤0.6% were significantly associated with reduced OS in one cohort each. On multivariate analysis, a combined score including absolute levels of neutrophils, lymphocytes, monocytes and eosinophils was significantly associated with OS in both cohorts. The hazard ratio of patients with a risk score of 3-4 was 5.42 (95% confidence interval: 1.52-19.42, P = 0.0094) in cohort 1 and 9.42 (2.06-43.06, P = 0.0038) in cohort 2, respectively.
CONCLUSIONS


We conclude that peripheral blood leukocytes are independently associated with OS in stage I-II melanoma patients and should be considered as prognostic markers in these patients. Eosinophils and basophils deserve more attention in future investigations.",2020,"On multivariate analysis, a combined score including absolute levels of neutrophils, lymphocytes, monocytes and eosinophils was significantly associated with OS in both cohorts.","['patients undergoing sentinel lymph node biopsy (SLNB', 'A total of 1412', 'AJCC stage I-II melanoma patients scheduled for SLNB at a single institution in the period 2010-2015 with available perioperative blood tests', 'melanoma patients undergoing SLNB', 'metastatic melanoma patients receiving immunotherapy', 'AJCC stage I-II melanoma patients scheduled for sentinel lymph node biopsy']",['peripheral blood leukocytic cells'],"['absolute levels of neutrophils, lymphocytes, monocytes and eosinophils', 'reduced OS', 'hazard ratio of patients with a risk score', 'Absolute monocytes >810/µL, absolute eosinophils', 'peripheral blood leukocytes', 'peripheral blood cells', 'overall survival (OS', 'absolute neutrophil count >5800/µL, relative neutrophil count']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0796693', 'cui_str': 'Sentinel Lymph Node Biopsy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]","[{'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}]",,0.28219,"On multivariate analysis, a combined score including absolute levels of neutrophils, lymphocytes, monocytes and eosinophils was significantly associated with OS in both cohorts.","[{'ForeName': 'Nikolaus B', 'Initials': 'NB', 'LastName': 'Wagner', 'Affiliation': 'Department of Dermatology and Venereology, University Medical Center Tubingen, University Tubingen, Tubingen, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Luttermann', 'Affiliation': 'Department of Dermatology and Venereology, University Medical Center Tubingen, University Tubingen, Tubingen, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Gassenmaier', 'Affiliation': 'Department of Dermatology and Venereology, University Medical Center Tubingen, University Tubingen, Tubingen, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Forschner', 'Affiliation': 'Department of Dermatology and Venereology, University Medical Center Tubingen, University Tubingen, Tubingen, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Leiter', 'Affiliation': 'Department of Dermatology and Venereology, University Medical Center Tubingen, University Tubingen, Tubingen, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Garbe', 'Affiliation': 'Department of Dermatology and Venereology, University Medical Center Tubingen, University Tubingen, Tubingen, Germany.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Eigentler', 'Affiliation': 'Department of Dermatology and Venereology, University Medical Center Tubingen, University Tubingen, Tubingen, Germany.'}]",The Australasian journal of dermatology,['10.1111/ajd.13248']
2735,32053534,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Austin Y', 'Initials': 'AY', 'LastName': 'Ha', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Guffey', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Myckatyn', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006783']
2736,32053538,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Knackstedt', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gatherwright', 'Affiliation': ''}, {'ForeName': 'Risal', 'Initials': 'R', 'LastName': 'Djohan', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006782']
2737,32053457,Pure Ormocer vs Methacrylate Composites on Posterior Teeth: A Double-blinded Randomized Clinical Trial.,"CLINICAL RELEVANCE


The clinical behavior of pure ormocer composite is reliable when used in class II restorations after 24 months of evaluation.
SUMMARY


",2020,The universal adhesive system (Futurabond M+) was applied in all restorations using the self-etching mode.,"['Posterior Teeth', '23 patients attended the recall and 46 restorations were evaluated', 'Thirty patients received two class II restorations (n=60) performed with']","['different composites: GrandioSO (methacrylate, nanohybrid) and Admira Fusion (pure ormocer, nanohybrid', 'class II restorations made using pure ormocer and methacrylate composites', 'Pure Ormocer vs Methacrylate Composites']","['general scores for esthetic, functional, and biological properties']","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C2828373', 'cui_str': 'Methacrylate'}, {'cui': 'C1313391', 'cui_str': 'admira'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C1259642', 'cui_str': 'Ormocer'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}]",23.0,0.123989,The universal adhesive system (Futurabond M+) was applied in all restorations using the self-etching mode.,"[{'ForeName': 'Crg', 'Initials': 'C', 'LastName': 'Torres', 'Affiliation': ''}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Augusto', 'Affiliation': ''}, {'ForeName': 'I F', 'Initials': 'IF', 'LastName': 'Mathias-Santamaria', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Di Nicoló', 'Affiliation': ''}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Borges', 'Affiliation': ''}]",Operative dentistry,['10.2341/19-079-C']
2738,32011181,"Acute Effects of Caffeine on Dynamic Accommodative Response and Pupil Size: A Placebo-controlled, Double-blind, Balanced Crossover Study.","OBJECTIVES


To evaluate the acute effect of caffeine consumption on the accuracy and variability of accommodation, as well as its impact on pupil size and perceived levels of activation.
METHODS


22 university students (21.68 ± 3.67 years old) ingested a capsule of caffeine (4 mg/kg) or placebo (300 mg of corn-starch) in two different days and counterbalanced order. After 30 min of capsule ingestion, we objectively measured the accuracy and variability of accommodation, and pupil size using the WAM-5500 binocular open-field autorefractometer for 2 min at each of the six viewing distances (5 m, 50 cm, 40 cm, 33 cm, 25 cm, and 20 cm). Subjective levels of activation to check the effectiveness of caffeine/placebo manipulation were also reported.
RESULTS


We found that after 30 min of caffeine/placebo ingestion, participant perceived higher levels of activation in the caffeine condition ( p  = .047, Cohen´s d = 0.48). Caffeine consumption induced a statistically significant dilator effect on pupil size ( p  = .011, η 2  = 0.271), and reduced variability of accommodative response ( p  = .027, η 2  = 0.211). However, no differences were obtained for the accuracy of accommodation ( p  = .321).
CONCLUSIONS


Our data suggest that caffeine consumption reduced the variability of accommodative response and induced pupil dilation. Nevertheless, the accuracy of accommodation was insensitive to caffeine intake. These findings may be explained by the bidirectional relationship between ocular functioning and the nervous system´s state of activation.",2020,"Caffeine consumption induced a statistically significant dilator effect on pupil size (p = 0.011, η 2  = 0.271), and reduced variability of accommodative response (p = 0.027, η 2  = 0.211).",['Methods : 22 university students (21.68 ± 3.67 years old'],"['caffeine consumption', 'caffeine/placebo', 'caffeine', 'placebo', 'ingested a capsule of caffeine']","['pupil size and perceived levels of activation', 'accuracy of accommodation', 'dynamic accommodative response and pupil size', 'variability of accommodative response and induced pupil dilation', 'levels of activation', 'accuracy and variability of accommodation, and pupil size using the WAM-5500 binocular open-field autorefractometer', 'dilator effect on pupil size', 'variability of accommodative response']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0948365', 'cui_str': 'Caffeine consumption'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]","[{'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0000936', 'cui_str': 'Ocular Distance Accommodation'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1827224', 'cui_str': 'Accommodative response (observable entity)'}, {'cui': 'C0026961', 'cui_str': 'Mydriasis'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0180431', 'cui_str': 'Dilator, device (physical object)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.187649,"Caffeine consumption induced a statistically significant dilator effect on pupil size (p = 0.011, η 2  = 0.271), and reduced variability of accommodative response (p = 0.027, η 2  = 0.211).","[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Redondo', 'Affiliation': 'Department of Optics, Faculty of Sciences, University of Granada , Granada, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Vera', 'Affiliation': 'Department of Optics, Faculty of Sciences, University of Granada , Granada, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Carreño-Rodríguez', 'Affiliation': 'Department of Optics, Faculty of Sciences, University of Granada , Granada, Spain.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Molina-Romero', 'Affiliation': 'Department of Optics, Faculty of Sciences, University of Granada , Granada, Spain.'}, {'ForeName': 'Raimundo', 'Initials': 'R', 'LastName': 'Jiménez', 'Affiliation': 'Department of Optics, Faculty of Sciences, University of Granada , Granada, Spain.'}]",Current eye research,['10.1080/02713683.2020.1725060']
2739,31406274,Differences in exposure to toxic and/or carcinogenic volatile organic compounds between Black and White cigarette smokers.,"OBJECTIVE


It is unclear why Black smokers in the United States have elevated risk of some tobacco-related diseases compared to White smokers. One possible causal mechanism is differential intake of tobacco toxicants, but results across studies are inconsistent. Thus, we examined racial differences in biomarkers of toxic volatile organic compounds (VOCs) present in tobacco smoke.
METHOD


We analyzed baseline data collected from 182 Black and 184 White adult smokers who participated in a randomized clinical trial in 2013-2014 at 10 sites across the United States. We examined differences in urinary levels of ten VOC metabolites, total nicotine equivalents (TNE), and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), controlling for covariates such as cigarettes per day (CPD), as well as differences in VOCs per TNE to assess the extent to which tobacco exposure, and not metabolic factors, accounted for racial differences.
RESULTS


Concentration of metabolites of acrolein, acrylonitrile, ethylene oxide, and methylating agents were significantly higher in Blacks compared to Whites when controlled for covariates. Other than the metabolite of methylating agents, VOCs per TNE did not differ between Blacks and Whites. Concentrations of TNE/CPD and VOCs/CPD were significantly higher in Blacks. Menthol did not contribute to racial differences in VOC levels.
CONCLUSIONS


For a given level of CPD, Black smokers likely take in higher levels of acrolein, acrylonitrile, and ethylene oxide than White smokers. Our findings are consistent with Blacks taking in more nicotine and toxicants per cigarette smoked, which may explain their elevated disease risk relative to other racial groups.",2019,Concentrations of TNE/CPD and VOCs,"['182 Black and 184 White adult smokers who participated in a randomized clinical trial in 2013-2014 at 10 sites across the United States', 'Black smokers', 'Black and White cigarette smokers']",['Menthol'],"['urinary levels of ten VOC metabolites, total nicotine equivalents (TNE), and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), controlling for covariates such as cigarettes per day (CPD', 'Concentrations of TNE/CPD and VOCs', 'Concentration of metabolites of acrolein, acrylonitrile, ethylene oxide, and methylating agents', 'CPD']","[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0591126', 'cui_str': 'AT 10'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}]","[{'cui': 'C0025368', 'cui_str': 'Menthol'}]","[{'cui': 'C0243173', 'cui_str': 'urinary levels'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0389836', 'cui_str': '4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C2001794', 'cui_str': '(BMIM)(TFSI) cpd'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0001204', 'cui_str': 'Acraldehyde'}, {'cui': 'C0001223', 'cui_str': 'Vinyl Cyanide'}, {'cui': 'C0015087', 'cui_str': 'Ethylene Oxide'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]",,0.0263075,Concentrations of TNE/CPD and VOCs,"[{'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'St Helen', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, CA, USA. Gideon.Sthelen@ucsf.edu.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ko', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Peyton', 'Initials': 'P', 'LastName': 'Jacob', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Gregorich', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Eliseo J', 'Initials': 'EJ', 'LastName': 'Pérez-Stable', 'Affiliation': 'Division of Intramural Research, National Heart, Lung and Blood Institute and Office of the Director, National Institute on Minority Health and Health Disparities, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sharon E', 'Initials': 'SE', 'LastName': 'Murphy', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Hecht', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Masonic Cancer Center, Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}]",Journal of exposure science & environmental epidemiology,['10.1038/s41370-019-0159-9']
2740,32029903,An analysis of the effect of mu-opioid receptor gene (OPRM1) promoter region DNA methylation on the response of naltrexone treatment of alcohol dependence.,"This study explored the effect of OPRM1 promoter region DNA methylation on the outcome of treatment with the opioid antagonist naltrexone (NTX) for alcohol dependence (AD). Ninety-three patients with DSM-IV AD [41 African Americans (AAs) and 52 European Americans (EAs)] received double-blind treatment with NTX or placebo for at least three months. Relapse to heavy drinking was assessed during the first 13 weeks of the trial. Peripheral blood methylation levels of 33 CpG units in the OPRM1 promoter region were quantified using Sequenom EpiTYPER technology. Bayesian logistic regression was used to analyze the effects of NTX treatment, CpG methylation, CpG methylation × NTX treatment, and age on AD relapse. The Random Forest machine learning algorithm was applied to select AD relapse predictors. No significant effect of individual OPRM1 promoter CpG units on AD relapse was observed in either AAs or EAs. Age was significantly associated with AD relapse in EAs, among whom older subjects had a lower relapse rate. Random forest analyses revealed that the prediction rate for AD relapse reached 66.0% with five top variables (age and four CpG units; ranked by their importance to AD relapse) in the prediction model. These findings suggest that methylation levels of individual OPRM1 promoter CpG units do not contribute significantly to inter-individual variation in NTX response. However, the age of subjects in combination with a cluster of specific OPRM1 promoter CpG units may affect NTX treatment outcome. Additional studies of OPRM1 DNA methylation changes during and after NTX treatment of AD are needed.",2020,No significant effect of individual OPRM1 promoter CpG units on AD relapse was observed in either AAs or EAs.,['Ninety-three patients with DSM-IV AD [41 African Americans (AAs) and 52 European Americans (EAs'],"['opioid antagonist naltrexone (NTX', 'NTX or placebo', 'OPRM1 promoter region DNA methylation']","['Peripheral blood methylation levels', 'AD relapse', 'relapse rate', 'prediction rate for AD relapse', 'Relapse to heavy drinking']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}]","[{'cui': 'C0027410', 'cui_str': 'Opioid Receptor Antagonists'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033413', 'cui_str': 'Promotor Regions'}, {'cui': 'C0376452', 'cui_str': 'DNA Methylation'}]","[{'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}]",93.0,0.0215557,No significant effect of individual OPRM1 promoter CpG units on AD relapse was observed in either AAs or EAs.,"[{'ForeName': 'Yufei', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Henry R', 'Initials': 'HR', 'LastName': 'Kranzler', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania and VISN4 MIRECC, Crescenz VAMC, Philadelphia, PA, USA.'}, {'ForeName': 'Lindsay A', 'Initials': 'LA', 'LastName': 'Farrer', 'Affiliation': 'Department of Medicine (Biomedical Genetics), Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Hongqin', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Hepatology, the First Hospital of Jilin University, Jilin University, Changchun, China.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Henderson', 'Affiliation': 'Department of Psychiatry, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry, Boston University School of Medicine, Boston, MA, USA. huipingz@bu.edu.'}]",The pharmacogenomics journal,['10.1038/s41397-020-0158-1']
2741,31784354,Machine Learning Identifies Large-Scale Reward-Related Activity Modulated by Dopaminergic Enhancement in Major Depression.,"BACKGROUND


Theoretical models have emphasized systems-level abnormalities in major depressive disorder (MDD). For unbiased yet rigorous evaluations of pathophysiological mechanisms underlying MDD, it is critically important to develop data-driven approaches that harness whole-brain data to classify MDD and evaluate possible normalizing effects of targeted interventions. Here, using an experimental therapeutics approach coupled with machine learning, we investigated the effect of a pharmacological challenge aiming to enhance dopaminergic signaling on whole-brain response to reward-related stimuli in MDD.
METHODS


Using a double-blind, placebo-controlled design, we analyzed functional magnetic resonance imaging data from 31 unmedicated MDD participants receiving a single dose of 50 mg amisulpride (MDD Amisulpride ), 26 MDD participants receiving placebo (MDD Placebo ), and 28 healthy control subjects receiving placebo (HC Placebo ) recruited through two independent studies. An importance-guided machine learning technique for model selection was used on whole-brain functional magnetic resonance imaging data probing reward anticipation and consumption to identify features linked to MDD (MDD Placebo  vs. HC Placebo ) and dopaminergic enhancement (MDD Amisulpride  vs. MDD Placebo ).
RESULTS


Highly predictive classification models emerged that distinguished MDD Placebo  from HC Placebo  (area under the curve = 0.87) and MDD Placebo  from MDD Amisulpride  (area under the curve = 0.89). Although reward-related striatal activation and connectivity were among the most predictive features, the best truncated models based on whole-brain features were significantly better relative to models trained using striatal features only.
CONCLUSIONS


Results indicate that in MDD, enhanced dopaminergic signaling restores abnormal activation and connectivity in a widespread network of regions. These findings provide new insights into the pathophysiology of MDD and pharmacological mechanism of antidepressants at the system level in addressing reward processing deficits among depressed individuals.",2020,"RESULTS


Highly predictive classification models emerged that distinguished MDD Placebo  from HC Placebo  (area under the curve = 0.87) and MDD Placebo  from MDD Amisulpride  (area under the curve = 0.89).","['31 unmedicated MDD participants receiving a single dose of 50 mg', '28 healthy control subjects receiving', '26 MDD participants receiving']","['amisulpride (MDD Amisulpride ', 'placebo (HC Placebo ', 'HC Placebo', 'placebo', 'dopaminergic enhancement (MDD Amisulpride  vs. MDD Placebo ', 'placebo (MDD Placebo ', 'Machine Learning Identifies', 'MDD (MDD Placebo  vs. HC Placebo ']",[],"[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0103045', 'cui_str': 'Amisulpride'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}]",[],26.0,0.291919,"RESULTS


Highly predictive classification models emerged that distinguished MDD Placebo  from HC Placebo  (area under the curve = 0.87) and MDD Placebo  from MDD Amisulpride  (area under the curve = 0.89).","[{'ForeName': 'Yuelu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'BlackThorn Therapeutics, San Francisco, California.'}, {'ForeName': 'Roee', 'Initials': 'R', 'LastName': 'Admon', 'Affiliation': 'Department of Psychology, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Monika S', 'Initials': 'MS', 'LastName': 'Mellem', 'Affiliation': 'BlackThorn Therapeutics, San Francisco, California.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Belleau', 'Affiliation': 'McLean Hospital, Belmont, Massachusetts; Department of Psychiatry, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Roselinde H', 'Initials': 'RH', 'LastName': 'Kaiser', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado, Boulder, Colorado.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Clegg', 'Affiliation': 'McLean Hospital, Belmont, Massachusetts.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Beltzer', 'Affiliation': 'McLean Hospital, Belmont, Massachusetts.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Goer', 'Affiliation': 'McLean Hospital, Belmont, Massachusetts.'}, {'ForeName': 'Gordana', 'Initials': 'G', 'LastName': 'Vitaliano', 'Affiliation': 'McLean Hospital, Belmont, Massachusetts; Department of Psychiatry, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Parvez', 'Initials': 'P', 'LastName': 'Ahammad', 'Affiliation': 'BlackThorn Therapeutics, San Francisco, California.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'McLean Hospital, Belmont, Massachusetts; Department of Psychiatry, Harvard Medical School, Boston, Massachusetts. Electronic address: dap@mclean.harvard.edu.'}]",Biological psychiatry. Cognitive neuroscience and neuroimaging,['10.1016/j.bpsc.2019.10.002']
2742,32032096,"Preoperative Cognitive Abnormality, Intraoperative Electroencephalogram Suppression, and Postoperative Delirium: A Mediation Analysis.","BACKGROUND


Postoperative delirium is a common complication that hinders recovery after surgery. Intraoperative electroencephalogram suppression has been linked to postoperative delirium, but it is unknown if this relationship is causal or if electroencephalogram suppression is merely a marker of underlying cognitive abnormalities. The hypothesis of this study was that intraoperative electroencephalogram suppression mediates a nonzero portion of the effect between preoperative abnormal cognition and postoperative delirium.
METHODS


This is a prespecified secondary analysis of the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) randomized trial, which enrolled patients age 60 yr or older undergoing surgery with general anesthesia at a single academic medical center between January 2015 and May 2018. Patients were randomized to electroencephalogram-guided anesthesia or usual care. Preoperative abnormal cognition was defined as a composite of previous delirium, Short Blessed Test cognitive score greater than 4 points, or Eight Item Interview to Differentiate Aging and Dementia score greater than 1 point. Duration of intraoperative electroencephalogram suppression was defined as number of minutes with suppression ratio greater than 1%. Postoperative delirium was detected via Confusion Assessment Method or chart review on postoperative days 1 to 5.
RESULTS


Among 1,113 patients, 430 patients showed evidence of preoperative abnormal cognition. These patients had an increased incidence of postoperative delirium (151 of 430 [35%] vs.123 of 683 [18%], P < 0.001). Of this 17.2% total effect size (99.5% CI, 9.3 to 25.1%), an absolute 2.4% (99.5% CI, 0.6 to 4.8%) was an indirect effect mediated by electroencephalogram suppression, while an absolute 14.8% (99.5% CI, 7.2 to 22.5%) was a direct effect of preoperative abnormal cognition. Randomization to electroencephalogram-guided anesthesia did not change the mediated effect size (P = 0.078 for moderation).
CONCLUSIONS


A small portion of the total effect of preoperative abnormal cognition on postoperative delirium was mediated by electroencephalogram suppression. Study precision was too low to determine if the intervention changed the mediated effect.",2020,"These patients had an increased incidence of postoperative delirium (151 of 430 [35%] vs.123 of 683 [18%], P < 0.001).","['1,113 patients, 430 patients', 'patients with preexisting cognitive impairment', 'enrolled patients age 60 yr or older undergoing surgery with general anesthesia at a single academic medical center between January 2015 and May 2018']","['Intraoperative electroencephalogram suppression', 'Electroencephalography Guidance of Anesthesia', 'electroencephalogram-guided anesthesia or usual care', 'intraoperative electroencephalogram suppression']","['Postoperative delirium', 'Duration of intraoperative electroencephalogram suppression', 'incidence of postoperative delirium', 'Preoperative abnormal cognition', 'preoperative abnormal cognition', 'postoperative delirium', 'Preoperative Cognitive Abnormality, Intraoperative Electroencephalogram Suppression, and Postoperative Delirium']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1527380', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1527380', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]",,0.120379,"These patients had an increased incidence of postoperative delirium (151 of 430 [35%] vs.123 of 683 [18%], P < 0.001).","[{'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Fritz', 'Affiliation': 'From the Department of Anesthesiology (B.A.F., C.R.K., A.B., A.M.M., T.P.B., J.O., D.P., H.R.M., T.S.W., M.S.A) the Division of Biostatistics (N.L.), Washington University School of Medicine, St. Louis, Missouri the Department of Mathematics and Statistics, Washington University in St. Louis, St. Louis, Missouri (N.L.). Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, University of Manitoba, Winnipeg, Canada Department of Medicine, Beth Israel-Deaconess Medical Center, Boston, Massachusetts Department of Medicine, Beth Israel-Deaconess Medical Center, Boston, Massachusetts Department of Medicine, Beth Israel-Deaconess Medical Center, Boston, Massachusetts Department of Medicine, Beth Israel-Deaconess Medical Center, Boston, Massachusetts Department of Occupational Therapy, Washington University School of Medicine, St. Louis, Missouri Department of Occupational Therapy, Washington University School of Medicine, St. Louis, Missouri Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri Department of Surgery, Washington University School of Medicine, St. Louis, Missouri Department of Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'King', 'Affiliation': ''}, {'ForeName': 'Arbi', 'Initials': 'A', 'LastName': 'Ben Abdallah', 'Affiliation': ''}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Mickle', 'Affiliation': ''}, {'ForeName': 'Thaddeus P', 'Initials': 'TP', 'LastName': 'Budelier', 'Affiliation': ''}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Oberhaus', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Maybrier', 'Affiliation': ''}, {'ForeName': 'Troy S', 'Initials': 'TS', 'LastName': 'Wildes', 'Affiliation': ''}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Avidan', 'Affiliation': ''}, {'ForeName': 'Ginika', 'Initials': 'G', 'LastName': 'Apakama', 'Affiliation': ''}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Aranake-Chrisinger', 'Affiliation': ''}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bolzenius', 'Affiliation': ''}, {'ForeName': 'Jamila', 'Initials': 'J', 'LastName': 'Burton', 'Affiliation': ''}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Cui', 'Affiliation': ''}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Emmert', 'Affiliation': ''}, {'ForeName': 'Shreya', 'Initials': 'S', 'LastName': 'Goswami', 'Affiliation': ''}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Graetz', 'Affiliation': ''}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': ''}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Jordan', 'Affiliation': ''}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kronzer', 'Affiliation': ''}, {'ForeName': 'Sherry L', 'Initials': 'SL', 'LastName': 'McKinnon', 'Affiliation': ''}, {'ForeName': 'Maxwell R', 'Initials': 'MR', 'LastName': 'Muench', 'Affiliation': ''}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Murphy', 'Affiliation': ''}, {'ForeName': 'Ben J', 'Initials': 'BJ', 'LastName': 'Palanca', 'Affiliation': ''}, {'ForeName': 'Aamil', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Spencer', 'Affiliation': ''}, {'ForeName': 'Tracey W', 'Initials': 'TW', 'LastName': 'Stevens', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Strutz', 'Affiliation': ''}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Tedeschi', 'Affiliation': ''}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Torres', 'Affiliation': ''}, {'ForeName': 'Emma R', 'Initials': 'ER', 'LastName': 'Trammel', 'Affiliation': ''}, {'ForeName': 'Ravi T', 'Initials': 'RT', 'LastName': 'Upadhyayula', 'Affiliation': ''}, {'ForeName': 'Anke C', 'Initials': 'AC', 'LastName': 'Winter', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Jacobsohn', 'Affiliation': ''}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Fong', 'Affiliation': ''}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Gallagher', 'Affiliation': ''}, {'ForeName': 'Sharon K', 'Initials': 'SK', 'LastName': 'Inouye', 'Affiliation': ''}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Schmitt', 'Affiliation': ''}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Somerville', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stark', 'Affiliation': ''}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': ''}, {'ForeName': 'Spencer J', 'Initials': 'SJ', 'LastName': 'Melby', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Tappenden', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003181']
2743,32027158,Investigating tobacco withdrawal in response to reduced nicotine cigarettes among smokers with opioid use disorder and other vulnerabilities.,"Individuals with opioid use disorder (OUD) have high prevalence of smoking and poor cessation outcomes. Data suggest that smokers with OUD may experience heightened nicotine reinforcement and more severe tobacco withdrawal compared to smokers without OUD. The Food and Drug Administration is currently considering reducing the nicotine content of cigarettes to reduce smoking prevalence and smoking-related disease. It is critical to understand the effects of reduced nicotine content cigarettes (RNCCs) on tobacco withdrawal in this subgroup. In this secondary analysis, we investigated the ability of RNCCs to attenuate acute tobacco withdrawal and craving severity in smokers with OUD versus those without substance use disorders (SUDs). Smokers maintained on methadone or buprenorphine (opioid-maintained [OM]; n = 65) versus without other SUDs (i.e., non-SUD; n = 135) completed 5 laboratory sessions wherein they smoked their usual brand (UB) or a research cigarette varying in nicotine content (0.4, 2.4, 5.2, 15.8 mg/g of tobacco) under double-blind, acute abstinence conditions. Participants completed the Minnesota Tobacco Withdrawal Scale, including a desire to smoke (craving) item, before and every 15 min for 1 hr following smoking each cigarette. Tobacco withdrawal and craving did not differ significantly by OM status in response to UB or RNCCs. In addition to the Dose × Time interaction, greater depression and cigarette dependence consistently predicted withdrawal and craving (ps < .05). Across all cigarettes, tobacco withdrawal and craving did not significantly differ by OM status, suggesting that smokers receiving opioid agonist treatment may respond favorably to RNCCs. Additional studies with larger and more diverse samples are needed to address this question more definitively. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,"Across all cigarettes, tobacco withdrawal and craving did not significantly differ by OM status, suggesting that smokers receiving opioid agonist treatment may respond favorably to RNCCs.","['smokers with opioid use disorder and other vulnerabilities', 'n = 65) versus without other SUDs (i.e., non-SUD; n = 135) completed 5', 'Individuals with opioid use disorder (OUD', 'smokers with OUD versus those without substance use disorders (SUDs']","['nicotine content cigarettes (RNCCs', 'methadone or buprenorphine', 'opioid-maintained [OM', 'laboratory sessions wherein they smoked their usual brand (UB) or a research cigarette varying in nicotine content']","['Minnesota Tobacco Withdrawal Scale, including a desire to smoke (craving) item', 'Tobacco withdrawal and craving', 'severe tobacco withdrawal', 'tobacco withdrawal and craving']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0222045'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.0499568,"Across all cigarettes, tobacco withdrawal and craving did not significantly differ by OM status, suggesting that smokers receiving opioid agonist treatment may respond favorably to RNCCs.","[{'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Streck', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Stacey C', 'Initials': 'SC', 'LastName': 'Sigmon', 'Affiliation': 'Vermont Center on Behavior and Health.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Priest', 'Affiliation': 'Vermont Center on Behavior and Health.'}, {'ForeName': 'Cecilia L', 'Initials': 'CL', 'LastName': 'Bergeria', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Danielle R', 'Initials': 'DR', 'LastName': 'Davis', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Hughes', 'Affiliation': 'Vermont Center on Behavior and Health.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Villanti', 'Affiliation': 'Vermont Center on Behavior and Health.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Center for Alcohol and Addiction Studies.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Heil', 'Affiliation': 'Vermont Center on Behavior and Health.'}, {'ForeName': 'Diann E', 'Initials': 'DE', 'LastName': 'Gaalema', 'Affiliation': 'Vermont Center on Behavior and Health.'}, {'ForeName': 'Maxine L', 'Initials': 'ML', 'LastName': 'Stitzer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Higgins', 'Affiliation': 'Vermont Center on Behavior and Health.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000350']
2744,31676670,Safety and Efficacy of Durvalumab and Tremelimumab Alone or in Combination in Patients with Advanced Gastric and Gastroesophageal Junction Adenocarcinoma.,"PURPOSE


This randomized, multicenter, open-label, phase Ib/II study assessed durvalumab and tremelimumab in combination or as monotherapy for chemotherapy-refractory gastric cancer or gastroesophageal junction (GEJ) cancer.
PATIENTS AND METHODS


Second-line patients were randomized 2:2:1 to receive durvalumab plus tremelimumab (arm A), or durvalumab (arm B) or tremelimumab monotherapy (arm C), and third-line patients received durvalumab plus tremelimumab (arm D). A tumor-based IFNγ gene signature was prospectively evaluated as a potential predictive biomarker in second- and third-line patients receiving the combination (arm E). The coprimary endpoints were objective response rate and progression-free survival (PFS) rate at 6 months.
RESULTS


A total of 113 patients were treated: 6 in phase Ib and 107 (arm A, 27; arm B, 24; arm C, 12; arm D, 25; arm E, 19) in phase II. Overall response rates were 7.4%, 0%, 8.3%, 4.0%, and 15.8% in the five arms, respectively. PFS rates at 6 months were 6.1%, 0%, 20%, 15%, and 0%, and 12-month overall survival rates were 37.0%, 4.6%, 22.9%, 38.8%, and NA, respectively. Treatment-related grade 3/4 adverse events were reported in 17%, 4%, 42%, 16%, and 11% of patients, respectively.
CONCLUSIONS


Response rates were low regardless of monotherapy or combination strategies. No new safety signals were identified. Including use of a tumor-based IFNγ signature and change in baseline and on-treatment circulating tumor DNA are clinically feasible and may be novel strategies to improve treatment response in this difficult-to-treat population.",2020,"Progression-free survival rates at 6 months were 6.1%, 0%, 20%, 15%, and 0%, and 12-month overall survival rates were 37.0%, 4.6%, 22.9%, 38.8%, and NA, respectively.","['chemotherapy-refractory gastric cancer (GC) or gastroesophageal junction (GEJ) cancer', '113 patients', 'Patients with Advanced Gastric and Gastroesophageal Junction Adenocarcinoma', 'Second-line patients', 'second- and third-line patients receiving the combination (arm E']","['Durvalumab and Tremelimumab Alone', 'durvalumab plus tremelimumab (arm A), or durvalumab (arm B) or tremelimumab monotherapy (arm C), and third-line patients received durvalumab plus tremelimumab (arm D', 'durvalumab and tremelimumab in combination or as monotherapy']","['grade 3/4 adverse events', 'objective response rate and progression-free survival rate', 'Overall response rates', 'Safety and Efficacy', 'overall survival rates', 'Progression-free survival rates']","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0014871', 'cui_str': 'Gastroesophageal Junction'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",113.0,0.0825744,"Progression-free survival rates at 6 months were 6.1%, 0%, 20%, 15%, and 0%, and 12-month overall survival rates were 37.0%, 4.6%, 22.9%, 38.8%, and NA, respectively.","[{'ForeName': 'Ronan J', 'Initials': 'RJ', 'LastName': 'Kelly', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University School of Medicine, Baltimore, Maryland. Ronan.Kelly@BSWHealth.org.'}, {'ForeName': 'Jeeyun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yung-Jue', 'Initials': 'YJ', 'LastName': 'Bang', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Khaldoun', 'Initials': 'K', 'LastName': 'Almhanna', 'Affiliation': 'Department of Medicine, Warren Alpert Medical School of Brown University, Providence, Rhode Island.'}, {'ForeName': 'Mariela', 'Initials': 'M', 'LastName': 'Blum-Murphy', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Daniel V T', 'Initials': 'DVT', 'LastName': 'Catenacci', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, The University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois.'}, {'ForeName': 'Hyun Cheol', 'Initials': 'HC', 'LastName': 'Chung', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Zev A', 'Initials': 'ZA', 'LastName': 'Wainberg', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Ronald Reagan UCLA Medical Center, Los Angeles, California.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Gibson', 'Affiliation': 'Division of Hematology and Oncology, Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Keun-Wook', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.'}, {'ForeName': 'Johanna C', 'Initials': 'JC', 'LastName': 'Bendell', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Nashville, Tennessee.'}, {'ForeName': 'Crystal S', 'Initials': 'CS', 'LastName': 'Denlinger', 'Affiliation': 'Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Cheng Ean', 'Initials': 'CE', 'LastName': 'Chee', 'Affiliation': 'Department of Hematology-Oncology, National University Cancer Institute, Singapore.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Omori', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Rom', 'Initials': 'R', 'LastName': 'Leidner', 'Affiliation': 'Earle A. Chiles Research Institute, Robert W. Franz Cancer Center, Providence Portland Medical Center, Providence Cancer Institute, Portland, Oregon.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'Department of Preventive Medicine, Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Yee', 'Initials': 'Y', 'LastName': 'Chao', 'Affiliation': 'Division of Medical Oncology, Center for Immuno-oncology, Department of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Marlon C', 'Initials': 'MC', 'LastName': 'Rebelatto', 'Affiliation': 'Oncology Translational Medicine, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Philip Z', 'Initials': 'PZ', 'LastName': 'Brohawn', 'Affiliation': 'Oncology Translational Medicine, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'He', 'Affiliation': 'Early Oncology Statistics, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McDevitt', 'Affiliation': 'Early Oncology Clinical Development, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Siddharth', 'Initials': 'S', 'LastName': 'Sheth', 'Affiliation': 'Early Oncology Clinical Development, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Judson M', 'Initials': 'JM', 'LastName': 'Englert', 'Affiliation': 'Early Oncology Clinical Development, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Geoffrey Y', 'Initials': 'GY', 'LastName': 'Ku', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-2443']
2745,32035945,"Efficacy and safety of microneedling and oral tranexamic acid in the treatment of facial melasma in women: An open, evaluator-blinded, randomized clinical trial.",,2020,,['facial melasma in women'],['microneedling and oral tranexamic acid'],['Efficacy and safety'],"[{'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.2716,,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cassiano', 'Affiliation': 'Departamento de Dermatologia, Universidade Federal de São Paulo - Escola Paulista de Medicina, São Paulo, Sao Paulo, Brazil. Electronic address: danielpcassiano@uol.com.br.'}, {'ForeName': 'Ana Cláudia Cavalcante', 'Initials': 'ACC', 'LastName': 'Esposito', 'Affiliation': 'Departamento de Dermatologia e Radioterapia, Universidade Estadual Paulista - Faculdade de Medicina de Botucatu, Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Karime', 'Initials': 'K', 'LastName': 'Hassun', 'Affiliation': 'Departamento de Dermatologia, Universidade Federal de São Paulo - Escola Paulista de Medicina, São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Ediléia', 'Initials': 'E', 'LastName': 'Bagatin', 'Affiliation': 'Departamento de Dermatologia, Universidade Federal de São Paulo - Escola Paulista de Medicina, São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Mariana Modesto D A', 'Initials': 'MMDA', 'LastName': 'Lima', 'Affiliation': 'Santa Casa de Misericórdia, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Emerson V A', 'Initials': 'EVA', 'LastName': 'Lima', 'Affiliation': 'Santa Casa de Misericórdia, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Luciane Donida Bartoli', 'Initials': 'LDB', 'LastName': 'Miot', 'Affiliation': 'Departamento de Dermatologia e Radioterapia, Universidade Estadual Paulista - Faculdade de Medicina de Botucatu, Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Hélio Amante', 'Initials': 'HA', 'LastName': 'Miot', 'Affiliation': 'Departamento de Dermatologia e Radioterapia, Universidade Estadual Paulista - Faculdade de Medicina de Botucatu, Botucatu, São Paulo, Brazil.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.02.002']
2746,32030525,"A Pilot Test of Game Changers, a Social Network Intervention to Empower People with HIV to be Prevention Advocates in Uganda.","We conducted a pilot randomized controlled trial of Game Changers, a 6-session group intervention that empowers people with HIV to be HIV prevention advocates in their social networks. Ninety-nine people with HIV (51 intervention, 48 wait-list control) and 58 of their social network members (alters) completed baseline and 5- and 8-month post-baseline assessments. Results indicated high acceptability, demonstrated by participants' and facilitators' positive attitudes qualitatively and favorable ratings of intervention sessions quantitatively, and high feasibility (76% attended all intervention sessions). Intention-to-treat analyses indicated significantly increased HIV prevention advocacy among HIV-positive participants and alters [b (SE) = 0.4 (0.2), p = .017; b (SE) = 0.4 (0.2), p = .035]; reduced internalized HIV stigma [b (SE) =  - 0.3 (0.1), p = .012], increased HIV-serostatus disclosure [b (SE) = 0.1 (0.1), p = .051], and increased social network density among HIV-positive participants [b (SE) = 0.1 (0.03), p = .004]; and marginally reduced condomless sex among alters [OR (95% CI) = 0.3 (0.1-1.2), p = .08]. Positioning people with HIV as central to prevention has the potential to reduce stigma and improve prevention outcomes throughout social networks.",2020,"Intention-to-treat analyses indicated significantly increased HIV prevention advocacy among HIV-positive participants and alters [b (SE) = 0.4 (0.2), p = .017; b (SE) = 0.4 (0.2), p = .035]; reduced internalized HIV stigma [b (SE) =  - 0.3 (0.1), p = .012], increased HIV-serostatus disclosure [b (SE) = 0.1 (0.1), p = .051], and increased social network density among HIV-positive participants [b (SE) = 0.1 (0.03), p = .004]; and marginally reduced condomless sex among alters [OR (95% CI) = 0.3 (0.1-1.2), p = .08].","['Ninety-nine people with HIV (51 intervention, 48 wait-list control) and 58 of their social network members (alters) completed baseline and 5- and 8-month post-baseline assessments', 'empowers people with HIV to be HIV prevention advocates in their social networks', 'Empower People with HIV to be Prevention Advocates in Uganda']","['6-session group intervention', 'Game Changers, a Social Network Intervention']","['HIV-serostatus disclosure', 'HIV prevention advocacy', 'internalized HIV stigma', 'social network density']","[{'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0150446', 'cui_str': 'Advocacy (regime/therapy)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}]",99.0,0.0801244,"Intention-to-treat analyses indicated significantly increased HIV prevention advocacy among HIV-positive participants and alters [b (SE) = 0.4 (0.2), p = .017; b (SE) = 0.4 (0.2), p = .035]; reduced internalized HIV stigma [b (SE) =  - 0.3 (0.1), p = .012], increased HIV-serostatus disclosure [b (SE) = 0.1 (0.1), p = .051], and increased social network density among HIV-positive participants [b (SE) = 0.1 (0.03), p = .004]; and marginally reduced condomless sex among alters [OR (95% CI) = 0.3 (0.1-1.2), p = .08].","[{'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Bogart', 'Affiliation': 'RAND Corporation, 1776 Main Street, P.O. Box 2138, Santa Monica, CA, 90407-2138, USA. lbogart@rand.org.'}, {'ForeName': 'Joseph K B', 'Initials': 'JKB', 'LastName': 'Matovu', 'Affiliation': 'Makerere University School of Public Health, Kampala, Uganda.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Wagner', 'Affiliation': 'RAND Corporation, 1776 Main Street, P.O. Box 2138, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'Harold D', 'Initials': 'HD', 'LastName': 'Green', 'Affiliation': 'RAND Corporation, 1776 Main Street, P.O. Box 2138, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'Erik D', 'Initials': 'ED', 'LastName': 'Storholm', 'Affiliation': 'RAND Corporation, 1776 Main Street, P.O. Box 2138, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Klein', 'Affiliation': 'RAND Corporation, 1776 Main Street, P.O. Box 2138, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Marsh', 'Affiliation': 'RAND Corporation, 1776 Main Street, P.O. Box 2138, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'MacCarthy', 'Affiliation': 'RAND Corporation, 1776 Main Street, P.O. Box 2138, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kambugu', 'Affiliation': 'Infectious Diseases Institute, Makerere University College of Health Sciences, Kampala, Uganda.'}]",AIDS and behavior,['10.1007/s10461-020-02806-4']
2747,32014696,Trainee Performance After Laparoscopic Simulator Training Using a Blackbox versus LapMentor.,"BACKGROUND


Training using laparoscopic high-fidelity simulators (LHFSs) to proficiency levels improves laparoscopic cholecystectomy skills. However, high-cost simulators and their limited availability could negatively impact residents' laparoscopic training opportunities. We aimed to assess whether motivation and surgical skill performance differ after basic skills training (BST) using a low-cost (Blackbox) versus LHFS (LapMentor) among medical students.
MATERIALS AND METHODS


Sixty-three medical students from Karolinska Institutet volunteered, completing written informed consent, questionnaire regarding expectations of the simulation training, and a visuospatial ability test. They were randomized into two groups that received BST using Blackbox (n = 32) or LapMentor (n = 31). However, seven students absence resulted in 56 participants, followed by another 9 dropouts. Subsequently, after training, 47 students took up three consecutive tests using the minimally invasive surgical trainer-virtual reality (MIST-VR) simulator, finalizing a questionnaire.
RESULTS


More Blackbox group participants completed all MIST-VR tests (29/31 versus 18/25). Students anticipated mastering LapMentor would be more difficult than Blackbox (P = 0.04). In those completing the simulation training, a trend toward an increase was noted in how well participants in the Blackbox group liked the simulator training (P = 0.07). Subgroup analysis of motivation and difficulty in liking the training regardless of simulator was found only in women (Blackbox [P = 0.02]; LapMentor [P = 0.06]). In the Blackbox group, the perceived difficulty of training, facilitation, and liking the Blackbox training (significant only in women) were significantly correlated with the students' performance in the MIST-simulator. No such correlations were found in the LapMentor group.
CONCLUSIONS


Results indicate an important role for low-tech/low-cost Blackbox laparoscopic BST of students in an otherwise high-tech surrounding. Furthermore, experience of Blackbox BST procedures correlate with students' performance in the MIST-VR simulator, with some gender-specific differences.",2020,"In those completing the simulation training, a trend toward an increase was noted in how well participants in the Blackbox group liked the simulator training (P = 0.07).","['Sixty-three medical students from Karolinska Institutet volunteered, completing written informed consent, questionnaire regarding expectations of the simulation training, and a visuospatial ability test', '47 students took up three consecutive tests using the', 'medical students']","['minimally invasive surgical trainer-virtual reality (MIST-VR) simulator, finalizing a questionnaire', 'Blackbox versus LapMentor', 'Blackbox', 'Training using laparoscopic high-fidelity simulators (LHFSs', 'basic skills training (BST) using a low-cost (Blackbox) versus LHFS (LapMentor', 'BST using Blackbox', 'LapMentor']","['perceived difficulty of training, facilitation, and liking the Blackbox training', 'MIST-VR tests', 'Trainee Performance']","[{'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]","[{'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",63.0,0.0271268,"In those completing the simulation training, a trend toward an increase was noted in how well participants in the Blackbox group liked the simulator training (P = 0.07).","[{'ForeName': 'Ninos', 'Initials': 'N', 'LastName': 'Oussi', 'Affiliation': 'Division of Surgery, CLINTEC, Karolinska Institutet, Stockholm, Sweden; Centre for Clinical Research Sörmland, Uppsala University, Eskilstuna, Sweden; Center for Advanced Medical Simulation and Training, Karolinska University Hospital, Stockholm, Sweden. Electronic address: ninos.oussi@ki.se.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Enochsson', 'Affiliation': 'Center for Advanced Medical Simulation and Training, Karolinska University Hospital, Stockholm, Sweden; Division of Surgery, Department of Surgical and Perioperative Sciences, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Henningsohn', 'Affiliation': 'Center for Advanced Medical Simulation and Training, Karolinska University Hospital, Stockholm, Sweden; Division of Urology, CLINTEC, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Castegren', 'Affiliation': 'Division of Surgery, CLINTEC, Karolinska Institutet, Stockholm, Sweden; Perioperative Medicine and Intensive Care (PMI), Karolinska University Hospital, Sweden.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Georgiou', 'Affiliation': 'Medical Physics Laboratory and Simulation Center, Medical School, University of Athens, Athens, Greece.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Kjellin', 'Affiliation': 'Division of Surgery, CLINTEC, Karolinska Institutet, Stockholm, Sweden; Center for Advanced Medical Simulation and Training, Karolinska University Hospital, Stockholm, Sweden.'}]",The Journal of surgical research,['10.1016/j.jss.2019.12.039']
2748,32024498,"Influence of ozonized water on pain, oedema, and trismus during impacted third molar surgery: a randomized, triple blind clinical trial.","BACKGROUND


This study aimed to evaluate the efficacy of ozonized water on pain, oedema and trismus after impacted third molar mandibular surgeries when compared to double distilled water. A randomized triple blind trial was conducted.
METHODS


Patients with third molars class II-B of Pell-Gregory were included, and surgical extraction was performed. Irrigation was done with ozonized (group 1) or double distilled water (group 2). The type of irrigation and the side to be operated were randomized. Neither the patients nor the operator or evaluator were aware of the irrigation solution. Pain, oedema and trismus were evaluated at baseline, 24-h, 48-h, 72-h and 7-days after treatment. The data were evaluated by Friedman, Wilcoxon, Mann-Whitney tests, and size effect.
RESULTS


It was included 8 men and 12 women, with a mean age of 20.9y.o. The initial pain mean was 7.94 (±12.81) (group 1) and 5.50 (±9.12) (group 2) (p > 0,05). There was a statistically significant reduction of pain, oedema and trismus in intragroup analysis (p < 0.05). There was no statistically significant difference (p > 0.05) when comparing the oedema and trismus between groups. The size effect ranged from small (0.23) to large (1.29).
CONCLUSIONS


It was concluded that ozonized water was compatible as irrigation method, not inferior to double distilled water, and had satisfactory effects on management of pain, oedema and trismus after surgical removal of the third molar.
TRIAL REGISTRATION


This clinical trial was registered in ClinicalTrials.gov NCT03501225 on April 18, 2018.",2020,"There was a statistically significant reduction of pain, oedema and trismus in intragroup analysis (p < 0.05).","['It was included 8 men and 12 women, with a mean age of 20.9y.o', 'Patients with third molars class II-B of Pell-Gregory were included, and surgical extraction was performed', 'during impacted third molar surgery']","['ozonized (group 1) or double distilled water', 'ozonized water']","['initial pain mean', 'Pain, oedema and trismus', 'oedema and trismus', 'pain, oedema, and trismus', 'pain, oedema and trismus']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1293139', 'cui_str': 'Surgical extraction'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0790233', 'cui_str': 'Distilled water'}, {'cui': 'C0043047', 'cui_str': 'Water'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}]",,0.271193,"There was a statistically significant reduction of pain, oedema and trismus in intragroup analysis (p < 0.05).","[{'ForeName': 'José Cristiano Ramos', 'Initials': 'JCR', 'LastName': 'Glória', 'Affiliation': 'Departament of Dentistry, Faculty of Biologic Sciences and Health, Federal University of Jequitinhonha and Mucuri Valleys, Rua da Glória, 187, Centro, Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Dhelfeson Willya', 'Initials': 'DW', 'LastName': 'Douglas-de-Oliveira', 'Affiliation': 'Departament of Dentistry, Faculty of Biologic Sciences and Health, Federal University of Jequitinhonha and Mucuri Valleys, Rua da Glória, 187, Centro, Diamantina, Minas Gerais, Brazil. dhelfeson@hotmail.com.'}, {'ForeName': 'Larissa Doalla Almeida', 'Initials': 'LDA', 'LastName': 'E Silva', 'Affiliation': 'Departament of Dentistry, Faculty of Biologic Sciences and Health, Federal University of Jequitinhonha and Mucuri Valleys, Rua da Glória, 187, Centro, Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Saulo Gabriel Moreira', 'Initials': 'SGM', 'LastName': 'Falci', 'Affiliation': 'Departament of Dentistry, Faculty of Biologic Sciences and Health, Federal University of Jequitinhonha and Mucuri Valleys, Rua da Glória, 187, Centro, Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Cássio Roberto Rocha', 'Initials': 'CRR', 'LastName': 'Dos Santos', 'Affiliation': 'Departament of Dentistry, Faculty of Biologic Sciences and Health, Federal University of Jequitinhonha and Mucuri Valleys, Rua da Glória, 187, Centro, Diamantina, Minas Gerais, Brazil.'}]",BMC oral health,['10.1186/s12903-020-1029-5']
2749,31698336,Evaluation of Step-Counting Interventions Differing on Intensity Messages.,"BACKGROUND


Step-counting interventions with discrepant intensity emphases may elicit different effects.
METHODS


A total of 120 sedentary/low-active, postmenopausal women were randomly assigned to one of the following 3 groups: (1) 10,000 steps per day (with no emphasis on walking intensity/speed/cadence; basic intervention, 49 completers), (2) 10,000 steps per day and at least 30 minutes in moderate intensity (ie, at a cadence of at least 100 steps per minute; enhanced intervention, 47 completers), or (3) a control group (19 completers). NL-1000-determined steps and active minutes (a device-specific indicator of time at moderate+ intensity) were collected as process variables during the 12-week intervention. Outcome variables included systolic and diastolic blood pressure, anthropometric measurements, fasting blood glucose and insulin, flow-mediated dilation, gait speed, and ActiGraph GT3X+-determined physical activity and sedentary behavior.
RESULTS


The ""basic group"" increased 5173 to 9602 steps per day and 9.2 to 30.2 active minutes per day. The ""enhanced group"" similarly increased 5061 to 10,508 steps per day and 8.7 to 38.8 active minutes per day. The only significant change over time for clinical variables was body mass index.
CONCLUSIONS


Interventions that use simple step-counters can achieve elevated volume and intensity of daily physical activity, regardless of emphasis on intensity. Despite this, few clinical outcomes were apparent in this sample of postmenopausal women with generally normal or controlled hypertension.",2020,"The ""enhanced group"" similarly increased 5061 to 10,508 steps per day and 8.7 to 38.8 active minutes per day.","['120 sedentary/low-active, postmenopausal women', 'postmenopausal women with generally normal or controlled hypertension']",[],"['systolic and diastolic blood pressure, anthropometric measurements, fasting blood glucose and insulin, flow-mediated dilation, gait speed, and ActiGraph GT3X+-determined physical activity and sedentary behavior', 'elevated volume and intensity of daily physical activity']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",[],"[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",120.0,0.0543753,"The ""enhanced group"" similarly increased 5061 to 10,508 steps per day and 8.7 to 38.8 active minutes per day.","[{'ForeName': 'Catrine', 'Initials': 'C', 'LastName': 'Tudor-Locke', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Schuna', 'Affiliation': ''}, {'ForeName': 'Damon L', 'Initials': 'DL', 'LastName': 'Swift', 'Affiliation': ''}, {'ForeName': 'Amber T', 'Initials': 'AT', 'LastName': 'Dragg', 'Affiliation': ''}, {'ForeName': 'Allison B', 'Initials': 'AB', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Church', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0439']
2750,32029537,PMI's heated tobacco products marketing claims of reduced risk and reduced exposure may entice youth to try and continue using these products.,"IMPORTANCE


Philip Morris International (PMI) is seeking Food and Drug Administration's (FDA) authorisation to market IQOS as a modified risk tobacco product and to make marketing claims of reduced risk and reduced exposure. Such claims may be misunderstood by youth, thereby increasing their risk for tobacco initiation.
OBJECTIVE


To assess youth (mean age 19.3, SD=1.7) understanding and perceptions of PMI's proposed consumer marketing claims of reduced risk and reduced exposure, we embedded a randomised controlled experiment into a survey of 450 California youth (April to August 2018). Participants were randomised to see 'reduced exposure', 'reduced risk' or neither claim. Perceptions of IQOS-related health risks and general harm and understanding of the term 'switching completely' as used in PMI's proposed claims were compared.
RESULTS


Mean expectancies to experience specific health risks did not differ by claim exposure. The reduced exposure group's perceptions of general harm did not differ from those of controls nor from the reduced risk group. The reduced risk group had the largest proportion who perceived IQOS as moderately/less harmful (n=78, 52%); controls the largest proportion perceiving IQOS as quite/extremely harmful (n=91, 63%). While 71% of the sample understood the term 'switch completely' correctly as used in the reduced risk (n=194, 71%) and reduced exposure (n=206, 72%) claims, more than 1 in 4 did not.
CONCLUSIONS


FDA and other regulators must use caution when considering allowing claims of reduced risk or reduced exposure to appear on retail tobacco packaging. Youth misunderstand such claims, and misperceptions of harm are known to lead to tobacco-use initiation.",2020,The reduced exposure group's perceptions of general harm did not differ from those of controls nor from the reduced risk group.,"['Philip Morris International (PMI', 'youth', '450 California youth (April to August 2018']",[],[],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0006754', 'cui_str': 'California'}]",[],[],,0.0426179,The reduced exposure group's perceptions of general harm did not differ from those of controls nor from the reduced risk group.,"[{'ForeName': 'Karma', 'Initials': 'K', 'LastName': 'McKelvey', 'Affiliation': 'Pediatrics/Adolescent Medicie, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baiocchi', 'Affiliation': 'Statistics, Stanford University Stanford Prevention Research Center, Stanford, California, USA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Halpern-Felsher', 'Affiliation': 'Pediatrics/Adolescent Medicie, Stanford University School of Medicine, Stanford, California, USA bonnieh@stanford.edu.'}]",Tobacco control,['10.1136/tobaccocontrol-2019-055318']
2751,30367938,Multicenter randomized phase 3 study of a sustained-release intracanalicular dexamethasone insert for treatment of ocular inflammation and pain after cataract surgery.,"PURPOSE


To assess the efficacy and safety of a sustained-release intracanalicular dexamethasone insert for the treatment of postoperative ocular inflammation and pain in patients having cataract surgery.
SETTING


Twenty-one United States sites.
DESIGN


Prospective multicenter randomized parallel-arm double-masked vehicle-controlled phase 3 study.
METHODS


Patients with planned clear corneal cataract surgery were randomized (1:1) to receive dexamethasone insert or placebo, and the treatment was placed in the canaliculus of the eye immediately after surgery (Day 1). The primary efficacy endpoints were complete absence of anterior chamber cells at Day 14 and complete absence of pain at Day 8.
RESULTS


The study comprised 438 adult patients (216 in the treatment arm and 222 in the placebo arm). At Day 14, significantly more patients had an absence of anterior chamber cells in the dexamethasone insert arm compared with placebo (52.3% versus 31.1%; P < .0001). At Day 8, significantly more patients had an absence of ocular pain in the dexamethasone insert arm compared with placebo (79.6% versus 61.3%; P < .0001). The dexamethasone insert arm showed no increase compared with placebo in incidence of all adverse events or ocular adverse events. Twice as many placebo patients required rescue therapy, compared with treated patients at Day 14.
CONCLUSIONS


Both primary endpoints were successfully met. In addition, patients receiving the dexamethasone insert experienced a decrease in inflammation after surgery as early as Day 4 through Day 45, and a decrease in pain as early as one day after surgery (Day 2) through Day 45. The dexamethasone insert was well-tolerated, and the adverse events profile was similar to placebo.",2019,"At Day 14, significantly more patients had an absence of anterior chamber cells in the dexamethasone insert arm compared with placebo (52.3% versus 31.1%; P < .0001).","['patients having cataract surgery', 'Twenty-one United States sites', '438 adult patients (216 in the treatment arm and 222 in the placebo arm', 'Patients with planned clear corneal cataract surgery', 'ocular inflammation and pain after cataract surgery']","['sustained-release intracanalicular dexamethasone', 'dexamethasone insert or placebo', 'dexamethasone', 'placebo']","['pain', 'inflammation', 'incidence of all adverse events or ocular adverse events', 'postoperative ocular inflammation and pain', 'absence of ocular pain', 'absence of anterior chamber cells', 'complete absence of anterior chamber cells at Day 14 and complete absence of pain at Day\xa08', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1306068', 'cui_str': 'Secondary Cataract'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0151827', 'cui_str': 'Eye pain'}, {'cui': 'C0423282', 'cui_str': 'Anterior chamber cells (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",438.0,0.51324,"At Day 14, significantly more patients had an absence of anterior chamber cells in the dexamethasone insert arm compared with placebo (52.3% versus 31.1%; P < .0001).","[{'ForeName': 'Syd L', 'Initials': 'SL', 'LastName': 'Tyson', 'Affiliation': 'Eye Associates of Vineland, Vineland, New Jersey, USA.'}, {'ForeName': 'Shamik', 'Initials': 'S', 'LastName': 'Bafna', 'Affiliation': 'Cleveland Eye Clinic, Brecksville, Ohio, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Gira', 'Affiliation': 'Ophthalmology Consultants, St. Louis, Missouri, USA.'}, {'ForeName': 'Damien F', 'Initials': 'DF', 'LastName': 'Goldberg', 'Affiliation': 'Wolstan & Goldberg Eye Associates, Torrance, California, USA.'}, {'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Jones', 'Affiliation': 'Jones Eye Clinic, Sioux City, Iowa, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Jones', 'Affiliation': 'Quantum Vision Centers, Belleville, Illinois, USA.'}, {'ForeName': 'Janet K', 'Initials': 'JK', 'LastName': 'Kim', 'Affiliation': 'Hull Eye Center, Lancaster, California, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Martel', 'Affiliation': 'Martel Eye Medical Group, Rancho Cordova, California, USA.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Nordlund', 'Affiliation': 'Cincinnati Eye Institute, Cincinnati, Ohio, USA.'}, {'ForeName': 'Ian K', 'Initials': 'IK', 'LastName': 'Piovanetti-Perez', 'Affiliation': 'Centro Oftalmico Metropolitano, San Juan, Puerto Rico, USA.'}, {'ForeName': 'Inder Paul', 'Initials': 'IP', 'LastName': 'Singh', 'Affiliation': 'Eye Centers of Racine & Kenosha, Racine, Wisconsin, USA.'}, {'ForeName': 'Jamie Lynne', 'Initials': 'JL', 'LastName': 'Metzinger', 'Affiliation': 'Ocular Therapeutix, Inc., Bedford, Massachusetts, USA. Electronic address: JMetzinger@ocutx.com.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Mulani', 'Affiliation': 'Ocular Therapeutix, Inc., Bedford, Massachusetts, USA.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Sane', 'Affiliation': 'Ocular Therapeutix, Inc., Bedford, Massachusetts, USA.'}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Talamo', 'Affiliation': 'Ocular Therapeutix, Inc., Bedford, Massachusetts, USA.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Goldstein', 'Affiliation': 'Ocular Therapeutix, Inc., Bedford, Massachusetts, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1016/j.jcrs.2018.09.023']
2752,31977840,Prediction of Smoking Abstinence in Women Living With Human Immunodeficiency Virus Infection.,"BACKGROUND


This study examined whether baseline negative emotional states (depression and anxiety) would predict craving for cigarettes and other nicotine withdrawal symptoms in early abstinence and whether those emotional states and withdrawal symptoms would predict failure in quitting smoking at 3 months postquit among U.S. women living with the human immunodeficiency virus (HIV).
METHOD


The study is a secondary analysis of data from two smoking cessation studies of women living with HIV. Craving for cigarettes and other withdrawal symptoms were assessed weekly with a total of 229 observations during the first 4 weeks following quit day. Descriptive statistics were used to examine baseline characteristics of the participants. A random growth curve model was used to estimate between-person differences in a within-person trend of changes in the withdrawal symptoms. A binary logistic regression analysis was performed to identify predictors of short-term smoking abstinence.
RESULTS


Baseline anxiety was a predictor of postquit nicotine withdrawal symptoms but baseline depression was not. Neither baseline anxiety nor depression predicted postquit craving for cigarettes. Participants who received an HIV-tailored smoking cessation intervention showed a greater decline in craving symptom than those who received an attention-controlled intervention. HIV-tailored intervention and less craving predicted smoking abstinence at 3-month follow-up.
DISCUSSION


Compared to an attention-controlled intervention, an HIV-tailored intervention effectively decreased craving for cigarette smoking after quitting-which effectively increased the rate of short-term smoking abstinence in women living with HIV.",2020,"Compared to an attention-controlled intervention, an HIV-tailored intervention effectively decreased craving for cigarette smoking after quitting-which effectively increased the rate of short-term smoking abstinence in women living with HIV.","['women living with HIV', 'Women Living with Human Immunodeficiency Virus Infection']","['HIV-tailored smoking cessation intervention', 'HIV-tailored intervention']","['craving symptom', 'rate of short-term smoking abstinence', 'Craving for cigarettes and other withdrawal symptoms', 'Smoking Abstinence']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}]",229.0,0.125838,"Compared to an attention-controlled intervention, an HIV-tailored intervention effectively decreased craving for cigarette smoking after quitting-which effectively increased the rate of short-term smoking abstinence in women living with HIV.","[{'ForeName': 'Sun S', 'Initials': 'SS', 'LastName': 'Kim', 'Affiliation': 'Sun S. Kim, PhD, RN, is Associate Professor, College of Nursing and Health Science, University of Massachusetts Boston. Mary E. Cooley, PhD, RN, FAAN, is Nurse Scientist, Phyllis F. Cantor Center, Dana-Farber Cancer Institute, Boston, Massachusetts. Sang A Lee, MS, RN, is Doctoral Student, College of Nursing and Health Science, University of Massachusetts Boston. Rosanna F. DeMarco, PhD, RN, FAAN, is Professor and Associate Dean for Academic Affairs, College of Nursing and Health Science, University of Massachusetts Boston.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Cooley', 'Affiliation': ''}, {'ForeName': 'Sang A', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Rosanna F', 'Initials': 'RF', 'LastName': 'DeMarco', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000421']
2753,32037199,A prospective comparative study to assess the efficacy and tolerability of 2 different doses of intravesical bacillus Calmette-Guerin (BCG) in patients with non-muscle-invasive bladder cancer.,"BACKGROUND


Bacillus Calmette-Guerin (BCG) is widely used as an immunotherapeutic agent and recommended in management of non-muscle-invasive bladder cancer (NMIBC). There is no consensus on the optimal dose of the BCG. However, dose reduction has been assessed to decrease the side effects following instillation of BCG. This study compared the efficacy and safety of 80 and 120 mg doses of Sii Onco BCG (Moscow I, Russian strain) in patients with NMIBC.
METHODS


Patients with histologically confirmed, completely resected solitary or multiple Ta or T1 (with or without carcinoma in situ), grade 1 to 3 urothelial carcinoma of the bladder were included. After transurethral resection of the tumor, repeated intravesical instillations with Sii Onco BCG (80 or 120 mg) were administered, following the induction and 3 weekly maintenance schedule (at 3, 6, 9, 15, 21, 27, and 33 months). Recurrence and progression of the tumor were monitored at scheduled time intervals using cystoscopy.
RESULTS


A total of 104 eligible patients were enrolled to receive 80 mg (n = 51) dose or 120 mg dose (n = 53) of Sii Onco BCG. On completion of 3 years follow-up, recurrence-free survival rate of 84.31% and 86.79% and progression-free survival rate of 84.31% and 94.34% were observed for 80 and 120 mg groups, respectively; difference being statistically nonsignificant.
CONCLUSION


Both, 80 and 120 mg doses of Sii Onco BCG are effective and safe for prophylaxis and management of NMIBC.",2020,80 and 120 mg doses of Sii Onco BCG are effective and safe for prophylaxis and management of NMIBC.,"['patients with NMIBC', '104 eligible patients', 'patients with non-muscle-invasive bladder cancer', 'Patients with histologically confirmed, completely resected solitary or multiple Ta or T1 (with or without carcinoma in situ), grade 1 to 3 urothelial carcinoma of the bladder were included']","['intravesical bacillus Calmette-Guerin (BCG', 'Sii Onco BCG (Moscow I, Russian strain', 'Bacillus Calmette-Guerin (BCG', 'Sii Onco BCG']","['Recurrence and progression of the tumor', 'efficacy and safety', 'efficacy and tolerability', 'side effects', 'recurrence-free survival rate', 'progression-free survival rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0007099', 'cui_str': 'Carcinoma, Intraepithelial'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0007138', 'cui_str': 'Carcinoma, Transitional Cell'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1289970', 'cui_str': 'Intravesical BCG'}, {'cui': 'C0085957', 'cui_str': 'BCG'}, {'cui': 'C0026580', 'cui_str': 'Moscow'}, {'cui': 'C0337816', 'cui_str': 'Russians (ethnic group)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",104.0,0.043771,80 and 120 mg doses of Sii Onco BCG are effective and safe for prophylaxis and management of NMIBC.,"[{'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Sood', 'Affiliation': 'Department of Urology, Dr. Ram Manohar Lohia Hospital, New Delhi, India.'}, {'ForeName': 'Hitt', 'Initials': 'H', 'LastName': 'Sharma', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India. Electronic address: drhjs@seruminstitute.com.'}, {'ForeName': 'Bhuvaneshwari', 'Initials': 'B', 'LastName': 'Sharma', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Parekh', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India.'}, {'ForeName': 'Pramod', 'Initials': 'P', 'LastName': 'Pujari', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Shewale', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India.'}]",Urologic oncology,['10.1016/j.urolonc.2020.01.002']
2754,32031643,Smartphones vs Wearable Devices for Remotely Monitoring Physical Activity After Hospital Discharge: A Secondary Analysis of a Randomized Clinical Trial.,,2020,,['After Hospital Discharge'],['Smartphones vs Wearable Devices for Remotely Monitoring Physical Activity'],[],"[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C4505348', 'cui_str': 'Wearable Electronic Devices'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",[],,0.291431,,"[{'ForeName': 'Mitesh S', 'Initials': 'MS', 'LastName': 'Patel', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Polsky', 'Affiliation': 'Leonard Davis Institute for Health Economics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Edward H', 'Initials': 'EH', 'LastName': 'Kennedy', 'Affiliation': 'Department of Statistics and Data Science, Carnegie Mellon University, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Dylan S', 'Initials': 'DS', 'LastName': 'Small', 'Affiliation': 'Wharton School, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Chalanda N', 'Initials': 'CN', 'LastName': 'Evans', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Charles A L', 'Initials': 'CAL', 'LastName': 'Rareshide', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.20677']
2755,31939564,Transcutaneous tibial nerve stimulation versus parasacral stimulation in the treatment of overactive bladder in elderly people: a triple-blinded randomized controlled trial.,"OBJECTIVES


To evaluate the effect of transcutaneous tibial nerve stimulation (TTNS) and transcutaneous parasacral stimulation on the treatment of overactive bladder (OAB) in elderly people and to compare the final results between groups.
METHODS


Fifty female volunteers, mean age 68.62 (±5.9) years, were randomly allocated into two groups: those receiving TTNS (G1, N=25) and those receiving transcutaneous parasacral stimulation (G2, N=25). The primary outcome was the International Consultation on Incontinence Questionnaire (ICIQ-OAB) score, and secondary outcomes were the International Consultation on Incontinence Questionnaire - short form (ICIQ-SF) score and 3-day bladder diary measurements. Volunteers were assessed before and after the treatment. Clinical Trials (ReBeC): RBR-9Q7J7Y.
RESULTS


Both groups' symptoms improved as measured by the ICIQ-OAB (G1 = <0.001; G2 = <0.001) and ICIQ-SF (G1 = <0.001; G2 = <0.001). In the 3-day bladder diary assessments after treatment, G1 showed a reduced number of nocturia (p<0.001), urgency (p<0.001) and urge urinary incontinence episodes (p<0.001), whereas G2 showed only a reduced number of nocturia episodes (p<0.001). No difference between groups was found.
CONCLUSION


Both of the proposed treatments were effective in the improvement of OAB symptoms, but TTNS showed a reduction in a greater number of symptoms as measured by the 3-day bladder diary. No differences were found between groups.",2020,"In the 3-day bladder diary assessments after treatment, G1 showed a reduced number of nocturia (p<0.001), urgency (p<0.001) and urge urinary incontinence episodes (p<0.001), whereas G2 showed only a reduced number of nocturia episodes (p<0.001).","['Fifty female volunteers, mean age 68.62', 'elderly people', 'overactive bladder in elderly people']","['TTNS (G1, N=25) and those receiving transcutaneous parasacral stimulation', 'Transcutaneous tibial nerve stimulation versus parasacral stimulation', 'transcutaneous tibial nerve stimulation (TTNS) and transcutaneous parasacral stimulation']","['OAB symptoms', 'overactive bladder (OAB', 'number of nocturia (p<0.001), urgency (p<0.001) and urge urinary incontinence episodes', 'International Consultation on Incontinence Questionnaire (ICIQ-OAB) score, and secondary outcomes were the International Consultation on Incontinence Questionnaire - short form (ICIQ-SF) score and 3-day bladder diary measurements', 'number of nocturia episodes']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0040186', 'cui_str': 'Tibial Nerve'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0150045', 'cui_str': 'Urinary Reflex Incontinence'}, {'cui': 'C2711460', 'cui_str': 'International consultation on incontinence questionnaire (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart (procedure)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}]",50.0,0.123912,"In the 3-day bladder diary assessments after treatment, G1 showed a reduced number of nocturia (p<0.001), urgency (p<0.001) and urge urinary incontinence episodes (p<0.001), whereas G2 showed only a reduced number of nocturia episodes (p<0.001).","[{'ForeName': 'Raquel Henriques', 'Initials': 'RH', 'LastName': 'Jacomo', 'Affiliation': 'Programa de Ciencias Medicas, Faculdade de Medicina, Universidade de Brasilia, Brasilia, DF, BR.'}, {'ForeName': 'Aline Teixeira', 'Initials': 'AT', 'LastName': 'Alves', 'Affiliation': 'Programa de Pos-Graduacao em Ciencias da Reabilitacao, Departamento de Fisioterapia, Universidade de Brasilia, Brasilia, DF, BR.'}, {'ForeName': 'Adélia', 'Initials': 'A', 'LastName': 'Lucio', 'Affiliation': 'Unidade de Reabilitacao, Hospital Universitario, Universidade do Mato Grosso do Sul, Campo Grande, MS, BR.'}, {'ForeName': 'Patrícia Azevedo', 'Initials': 'PA', 'LastName': 'Garcia', 'Affiliation': 'Programa de Pos-Graduacao em Ciencias da Reabilitacao, Departamento de Fisioterapia, Universidade de Brasilia, Brasilia, DF, BR.'}, {'ForeName': 'Dayanne Cristina Ramos', 'Initials': 'DCR', 'LastName': 'Lorena', 'Affiliation': 'Programa de Pos-Graduacao em Ciencias da Reabilitacao, Departamento de Fisioterapia, Universidade de Brasilia, Brasilia, DF, BR.'}, {'ForeName': 'João Batista', 'Initials': 'JB', 'LastName': 'de Sousa', 'Affiliation': 'Programa de Ciencias Medicas, Faculdade de Medicina, Universidade de Brasilia, Brasilia, DF, BR.'}]","Clinics (Sao Paulo, Brazil)",['10.6061/clinics/2020/e1477']
2756,32027157,Trajectories of change in well-being during cognitive behavioral therapies for anxiety disorders: Quantifying the impact and covariation with improvements in anxiety.,"Cognitive behavioral therapy (CBT) has been found to be very effective in reducing many forms of mental illness, but much less is known about whether CBT also promotes mental health or well-being. The goals of the present study were to (a) quantify the magnitude and timing of changes in overall well-being and specific facets of well-being during different CBTs for anxiety disorders, (b) determine whether these effects vary across transdiagnostic and disorder-specific CBT, and (c) examine how changes in well-being during treatment relate to changes in anxiety. A total of 223 adults (55.6% female, Mage = 31.1 years) were randomized to 1 of 5 CBT protocols for anxiety disorders at an outpatient clinic. Analyses included standardized mean gain effect sizes (ESsg) and latent growth curve modeling. Moderate-to-large increases in overall well-being and the 3 components of subjective, psychological, and social well-being were observed, mainly during the second half of CBT, and these increases were maintained at a 6-month follow-up. The magnitude of effects was comparable for transdiagnostic and disorder-specific CBT protocols and greater than in the waitlist condition. Parallel process latent growth curve models indicated that trajectories of change in well-being across treatment were strongly correlated with trajectories of change in clinician-rated and self-reported anxiety. Together, these findings suggest that different CBT protocols for anxiety consistently produce robust and lasting changes in well-being, and these changes are strongly linked to changes in anxiety during treatment. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,The magnitude of effects was comparable for transdiagnostic and disorder-specific CBT protocols and greater than in the waitlist condition.,"['anxiety disorders', '223 adults (55.6% female, Mage = 31.1 years']","['cognitive behavioral therapies', 'CBT protocols', 'Cognitive behavioral therapy (CBT']","['standardized mean gain effect sizes (ESsg) and latent growth curve modeling', 'anxiety']","[{'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205275', 'cui_str': 'Latent (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",223.0,0.0152392,The magnitude of effects was comparable for transdiagnostic and disorder-specific CBT protocols and greater than in the waitlist condition.,"[{'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Gallagher', 'Affiliation': 'Department of Psychology, Texas Institute for Measurement, Evaluation, and Statistics, University of Houston.'}, {'ForeName': 'Colleen A', 'Initials': 'CA', 'LastName': 'Phillips', 'Affiliation': 'Department of Psychology, Texas Institute for Measurement, Evaluation, and Statistics, University of Houston.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': ""D'Souza"", 'Affiliation': 'Department of Psychology, Texas Institute for Measurement, Evaluation, and Statistics, University of Houston.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Richardson', 'Affiliation': 'Department of Psychology, Texas Institute for Measurement, Evaluation, and Statistics, University of Houston.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Long', 'Affiliation': 'Department of Psychology, Texas Institute for Measurement, Evaluation, and Statistics, University of Houston.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Boswell', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York.'}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Farchione', 'Affiliation': 'Department of Psychology, Boston University.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Barlow', 'Affiliation': 'Department of Psychology, Boston University.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000283']
2757,32010994,New Predictive Equations for Estimating Resting Energy Expenditure in Adults With Crohn's Disease.,"BACKGROUND


Increased resting energy expenditure (REE) has been hypothesized to be a potential cause of weight loss in individuals with Crohn's disease (CD). This study aimed to develop and validate new predictive equations for estimating REE in adults with CD.
METHODS


Adults, ages 18-65 years, with CD were recruited. Anthropometry, indirect calorimetry, and bioimpedance analysis were performed in all patients. Disease activity was assessed by Crohn's Disease Activity Index. The new predictive equations were generated using different regression models. Prediction accuracy of the new equations was assessed and compared with the most commonly used equations.
RESULTS


A total of 270 CD patients (159 males, 111 females) were included and randomly assigned to the calibration (n = 180) and validation groups (n = 90). REE was directly correlated with weight and bioimpedance index, whereas the relation with both age and disease activity was inverse. The new equations were suitable for estimating REE at population level (bias: -0.2 and -0.3, respectively). Individual accuracy was good in both models (≥80%, respectively), especially in females; and similar results were shown by some of the selected equations. But, when accuracy was set within ±5%, the new equations gave the highest prediction.
CONCLUSION


The new, disease-specific, equations for predicting REE in individuals with CD give a good prediction accuracy as far as those proposed in the literature for the general population. However, the new ones performed better at the individual level. Further studies are needed to verify the reliability and usefulness of these new equations.",2020,"The new equations were suitable for estimating REE at population level (bias: -0.2 and -0.3, respectively).","['Adults', 'Adults, ages 18-65 years, with CD were recruited', ""individuals with Crohn's disease (CD"", 'adults with CD', 'individuals with CD', '270 CD patients (159 males, 111 females']",[],"['REE', 'weight and bioimpedance index', 'Individual accuracy', 'Disease activity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]",[],"[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",270.0,0.0273976,"The new equations were suitable for estimating REE at population level (bias: -0.2 and -0.3, respectively).","[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Marra', 'Affiliation': 'Internal Medicine and Clinical Nutrition Unit, Department of Clinical Medicine and Surgery, Federico II University Hospital, Naples, Italy.'}, {'ForeName': 'Iolanda', 'Initials': 'I', 'LastName': 'Cioffi', 'Affiliation': 'Internal Medicine and Clinical Nutrition Unit, Department of Clinical Medicine and Surgery, Federico II University Hospital, Naples, Italy.'}, {'ForeName': 'Delia', 'Initials': 'D', 'LastName': 'Morlino', 'Affiliation': 'Internal Medicine and Clinical Nutrition Unit, Department of Clinical Medicine and Surgery, Federico II University Hospital, Naples, Italy.'}, {'ForeName': 'Olivia Di', 'Initials': 'OD', 'LastName': 'Vincenzo', 'Affiliation': 'Internal Medicine and Clinical Nutrition Unit, Department of Clinical Medicine and Surgery, Federico II University Hospital, Naples, Italy.'}, {'ForeName': 'Maria Carmen', 'Initials': 'MC', 'LastName': 'Pagano', 'Affiliation': 'Internal Medicine and Clinical Nutrition Unit, Department of Clinical Medicine and Surgery, Federico II University Hospital, Naples, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Imperatore', 'Affiliation': 'Gastroenterology Unit, Department of Clinical Medicine and Surgery, Federico II University Hospital, Naples, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Alfonsi', 'Affiliation': 'Internal Medicine and Clinical Nutrition Unit, Department of Clinical Medicine and Surgery, Federico II University Hospital, Naples, Italy.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Santarpia', 'Affiliation': 'Internal Medicine and Clinical Nutrition Unit, Department of Clinical Medicine and Surgery, Federico II University Hospital, Naples, Italy.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Castiglione', 'Affiliation': 'Gastroenterology Unit, Department of Clinical Medicine and Surgery, Federico II University Hospital, Naples, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Scalfi', 'Affiliation': 'Department of Public Health, Federico II University Hospital, Naples, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Pasanisi', 'Affiliation': 'Internal Medicine and Clinical Nutrition Unit, Department of Clinical Medicine and Surgery, Federico II University Hospital, Naples, Italy.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1790']
2758,30527440,Tolerability and toxicity of topically applied nepafenac 0.3% compared with generic ketorolac 0.5.,"PURPOSE


To compare patient-reported tolerability, impact on quality of life, interference with activities of daily life, and ocular surface toxicity of branded nepafenac 0.3% and generic ketorolac 0.5% after cataract surgery.
SETTING


Harvard Eye Associates, Laguna Hills, California, and the Cincinnati Eye Institute, Ohio, USA.
DESIGN


Prospective case series.
METHODS


One eye of each patient was randomized to receive ketorolac 0.5% or nepafenac 0.3% topical eyedrops for 3 days preoperatively and 28 days postoperatively. Additional medications were moxifloxacin 0.5% 4 times a day 3 days preoperatively and 7 days postoperatively and difluprednate 0.05% twice a day for 1 week postoperatively. Primary endpoints were patient-reported tolerability of each drug, the related impact on quality of life, and activities of daily life. Secondary endpoints were differences in conjunctival hyperemia, anterior chamber inflammation, tear breakup time (TBUT), and corneal staining.
RESULTS


Baseline characteristics were similar between the nepafenac group (n = 91) and the ketorolac group (n = 90). Burning and stinging lasted longer in the ketorolac group, while blurry/hazy/foggy vision and a film or coating on the eye lasted longer in the nepafenac group (all P < .0001). All objective measures were statistically significant for ketorolac 0.5% versus nepafenac 0.3% as follows: corneal staining (64% versus 28%); Oxford grade 2 or greater staining (28% versus 4%); Schulze grade 30 or greater conjunctival erythema (65% versus 36%, respectively); abnormal TBUT greater than 10 seconds (77% versus 51%) (all P < .0001).
CONCLUSION


Branded nepafenac 0.3%-treated patients had significantly better objective and subjective outcomes after cataract surgery than generic ketorolac 0.5%-treated patients.",2019,All objective measures were statistically significant for ketorolac 0.5% versus nepafenac 0.3% as follows:,['One eye of each patient'],"['nepafenac', 'generic ketorolac', 'ketorolac 0.5% or nepafenac 0.3% topical eyedrops', 'ketorolac', 'moxifloxacin']","['corneal staining', 'Tolerability and toxicity', 'objective and subjective outcomes', 'conjunctival erythema', 'quality of life, interference with activities of daily life, and ocular surface toxicity', 'conjunctival hyperemia, anterior chamber inflammation, tear breakup time (TBUT), and corneal staining', 'quality of life, and activities of daily life']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0961209', 'cui_str': 'nepafenac'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]","[{'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern (observable entity)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0034380'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia (finding)'}, {'cui': 'C1096278', 'cui_str': 'Anterior chamber inflammation'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",91.0,0.0902625,All objective measures were statistically significant for ketorolac 0.5% versus nepafenac 0.3% as follows:,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hovanesian', 'Affiliation': 'Harvard Eye Associates, Laguna Hills, California, USA. Electronic address: johnhova@gmail.com.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Holland', 'Affiliation': 'Cincinnati Eye Institute, Ohio, USA.'}]",Journal of cataract and refractive surgery,['10.1016/j.jcrs.2018.08.039']
2759,32020032,Timing of exercise for muscle strength and physical function in men initiating ADT for prostate cancer.,"BACKGROUND


Androgen deprivation therapy (ADT) in men with prostate cancer (PCa) results in adverse effects, including reduced muscle strength and physical function, potentially compromising daily functioning. We examined whether it was more efficacious to commence exercise at the onset of ADT rather than later in treatment to counter declines in strength and physical function.
METHODS


One-hundred-and-four men with PCa (68.3 ± 7.0 years) initiating ADT were randomised to immediate exercise (IMX, n = 54) or delayed exercise (DEL, n = 50) for 12 months. IMX comprised 6 months of supervised resistance/aerobic/impact exercise initiated at the onset of ADT with a 6-month follow-up. DEL comprised 6 months of usual care followed by 6 months of resistance/aerobic/impact exercise. Upper and lower body muscle strength and physical function were assessed at baseline, 6 and 12 months.
RESULTS


There was a significant difference for all strength measures at 6 months favouring IMX (P < 0.001), with net differences in leg press, seated row and chest press strength of 19.9 kg (95% CI, 12.3-27.5 kg), 5.6 kg (3.8-7.4 kg) and 4.3 kg (2.7-5.8 kg), respectively. From 7 to 12 months, DEL increased in all strength measures (P < 0.001), with no differences between groups at 12 months. Similarly, physical function improved (P < 0.001) in IMX compared with DEL at 6 months for the 6-m fast walk (-0.2, 95% CI -0.3 to -0.1 s), 400-m walk (-9.7, -14.8 to -4.6 s), stair climb (-0.4, -0.6 to -0.2 s) and chair rise (-1.0, -1.4 to -0.7 s), with no differences between groups by 12 months, except for the 6-m fast walk (P < 0.001).
CONCLUSION


Exercise either at the onset or after 6 months of ADT preserves/enhances muscle strength and physical function. However, to avoid initial treatment-related adverse effects on strength and function, exercise therapy should be implemented with initiation of ADT.",2020,"There was a significant difference for all strength measures at 6 months favouring IMX (P < 0.001), with net differences in leg press, seated row and chest press strength of 19.9 kg (95% CI, 12.3-27.5 kg), 5.6 kg (3.8-7.4 kg) and 4.3 kg (2.7-5.8 kg), respectively.","['men with prostate cancer (PCa', 'One-hundred-and-four men with PCa (68.3\u2009±\u20097.0 years) initiating ADT', 'men initiating ADT for prostate cancer']","['immediate exercise (IMX, n\u2009=\u200954) or delayed exercise (DEL', 'IMX', 'Androgen deprivation therapy (ADT']","['strength measures', 'physical function', 'chair rise', 'stair climb', 'leg press, seated row and chest press strength', 'Upper and lower body muscle strength and physical function', 'muscle strength and physical function']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed (observable entity)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",104.0,0.0802218,"There was a significant difference for all strength measures at 6 months favouring IMX (P < 0.001), with net differences in leg press, seated row and chest press strength of 19.9 kg (95% CI, 12.3-27.5 kg), 5.6 kg (3.8-7.4 kg) and 4.3 kg (2.7-5.8 kg), respectively.","[{'ForeName': 'Robert U', 'Initials': 'RU', 'LastName': 'Newton', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia. r.newton@ecu.edu.au.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Galvão', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Spry', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Joseph', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Suzanne K', 'Initials': 'SK', 'LastName': 'Chambers', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Gardiner', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Dickon', 'Initials': 'D', 'LastName': 'Hayne', 'Affiliation': 'UWA Medical School, University of Western Australia, Crawley, WA, Australia.'}, {'ForeName': 'Dennis R', 'Initials': 'DR', 'LastName': 'Taaffe', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0200-z']
2760,32020523,"The Effect of Zinc Supplementation on Steatosis Severity and Liver Function Enzymes in Overweight/Obese Patients with Mild to Moderate Non-alcoholic Fatty Liver Following Calorie-Restricted Diet: a Double-Blind, Randomized Placebo-Controlled Trial.","The role of zinc is known in balancing the oxidant/antioxidant system and also in improving insulin resistance in many diseases. Recently, in vivo and in vitro studies revealed roles of zinc on lipophagy and suppressing hepatic lipid deposition. The present study is the first double-blind randomized clinical trial that investigated the effect of zinc supplement on clinical manifestations and anthropometric parameters of overweight/obese non-alcoholic fatty liver patients following calorie-restricted diet. Fifty-six overweight/obese subjects with confirmed non-alcoholic fatty liver disease (NAFLD) using ultrasonography were randomized to treatment (calorie-restricted diet plus 30 mg/day zinc supplement) or placebo (calorie-restricted diet and placebo) groups. Serum liver enzymes and liver steatosis were measured at the baseline and 12 weeks post-intervention. Anthropometric measurements and food recalls were collected at the beginning, weeks 6 and 12. Zinc supplementation significantly elevated serum zinc concentrations in the treatment group (p < 0.001). Treatment also reduced alanine aminotransferase and γ-glutamyl transpeptidase enzymes in the treatment group (p < 0.05). Waist circumference was also significantly lowered in the zinc group (p < 0.05). Liver steatosis and fatty liver index changes were not significant between the groups. Overall, beneficial effects of zinc supplementation were shown on serum levels of zinc and liver enzymes in overweight/obese NAFLD patients.",2020,Treatment also reduced alanine aminotransferase and γ-glutamyl transpeptidase enzymes in the treatment group (p < 0.05).,"['Overweight/Obese Patients with Mild to Moderate Non-alcoholic Fatty Liver Following Calorie-Restricted Diet', 'overweight/obese NAFLD patients', 'overweight/obese non-alcoholic fatty liver patients following calorie-restricted diet', 'Fifty-six overweight/obese subjects with confirmed non-alcoholic fatty liver disease (NAFLD) using ultrasonography']","['Placebo', 'Zinc supplementation', 'treatment (calorie-restricted diet plus 30\xa0mg/day zinc supplement) or placebo (calorie-restricted diet and placebo', 'Zinc Supplementation', 'zinc supplement', 'zinc supplementation']","['elevated serum zinc concentrations', 'Serum liver enzymes and liver steatosis', 'Waist circumference', 'Steatosis Severity and Liver Function Enzymes', 'reduced alanine aminotransferase and γ-glutamyl transpeptidase enzymes', 'serum levels of zinc and liver enzymes', 'Anthropometric measurements and food recalls', 'Liver steatosis and fatty liver index changes']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C3541396', 'cui_str': 'Zinc'}]","[{'cui': 'C0856205', 'cui_str': 'Serum zinc'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration (morphologic abnormality)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0017040', 'cui_str': 'gammaglutamyltransferase'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",56.0,0.510609,Treatment also reduced alanine aminotransferase and γ-glutamyl transpeptidase enzymes in the treatment group (p < 0.05).,"[{'ForeName': 'Mojdeh', 'Initials': 'M', 'LastName': 'Fathi', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Isfahan Province, Iran.'}, {'ForeName': 'Pezhman', 'Initials': 'P', 'LastName': 'Alavinejad', 'Affiliation': 'Alimentary Tract Research Center, Ahvaz Imam Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Khuzestan Province, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Haidari', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Isfahan University of Medical Sciences, Isfahan, Isfahan Province, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Amani', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Isfahan Province, Iran. r_amani@mail.mui.ac.ir.'}]",Biological trace element research,['10.1007/s12011-019-02015-8']
2761,31957046,"Healthcare utilisation and measles, mumps and rubella vaccination rates among children with an extended postnatal home visiting programme in a disadvantaged area in Stockholm, Sweden-A 3-year follow-up.","AIM


To follow up healthcare utilisation and measles, mumps and rubella (MMR) vaccination rates among children 0-36 months, receiving an extended postnatal home visiting programme in a disadvantaged area with poorer child health, and in control groups, in Stockholm, Sweden.
METHODS


We analysed electronic child health records regarding outpatient visits, inpatient episodes and MMR vaccination for children 0-36 months receiving the home visiting programme (Intervention Group) and in control groups (Control Group and Rinkeby Comparison Group).
RESULTS


Children in the Intervention Group had significantly higher MMR vaccination rate than children in the Rinkeby Comparison Group. Healthcare utilisation was similar in the Intervention Group and the control groups. In stratified analyses by number of home visits received, children receiving the recommended six home visits had significantly fewer inpatient episodes and somewhat fewer emergency visits than those receiving fewer home visits.
CONCLUSION


The extended home visiting programme had a positive impact on the MMR vaccination rate. Children receiving the recommended six home visits had lower use of inpatient care. In addition to being positively perceived by parents in an area with greater healthcare needs, the programme may have a positive impact on their children's healthcare utilisation.",2020,Health care utilisation was similar in the Intervention Group and the control groups.,"['children 0-36 months, receiving an extended postnatal home visiting programme in a disadvantaged area with poorer child health, and in control groups, in Stockholm, Sweden', 'children with an extended postnatal home visiting programme in a disadvantaged area in Stockholm, Sweden - a three-year follow-up', 'Children in the Intervention Group', 'children 0-36 months receiving the']",['home visiting programme (Intervention Group) and in control groups (Control Group and Rinkeby Comparison Group'],"['rubella (MMR) vaccination rates', 'Health care utilisation and measles, mumps, rubella vaccination rates', 'inpatient episodes', 'MMR vaccination rate', 'Health care utilisation', 'emergency visits']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042206', 'cui_str': 'Rubella vaccination (procedure)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0025007', 'cui_str': 'Rubeola'}, {'cui': 'C0026780', 'cui_str': 'Parotitis, Epidemic'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0199810', 'cui_str': 'Measles-mumps-rubella vaccination (procedure)'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}]",,0.0481533,Health care utilisation was similar in the Intervention Group and the control groups.,"[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Burström', 'Affiliation': 'Department of Public Health Sciences, Equity and Health Policy Research Group, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Mellblom', 'Affiliation': 'Rinkeby Child Health Care Centre, Stockholm County Council Health Services, Stockholm, Sweden.'}, {'ForeName': 'Anneli', 'Initials': 'A', 'LastName': 'Marttila', 'Affiliation': 'Department of Public Health Sciences, Equity and Health Policy Research Group, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Asli', 'Initials': 'A', 'LastName': 'Kulane', 'Affiliation': 'Department of Public Health Sciences, Equity and Health Policy Research Group, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Martin', 'Affiliation': 'Stockholm County Council Child Health Services, Stockholm, Sweden.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Lindberg', 'Affiliation': 'Centre for Epidemiology and Community Medicine, Stockholm County Council Health Services, Stockholm, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Burström', 'Affiliation': 'Department of Public Health Sciences, Equity and Health Policy Research Group, Karolinska Institutet, Stockholm, Sweden.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15176']
2762,32009422,Post-needling soreness and trigger point dry needling for hemiplegic shoulder pain following stroke.,"OBJECTIVES


To determine the presence of post-needling induced pain in subjects who had suffered a stroke and received trigger point (TrP) dry needling (DN), and to investigate the effects of including TrP-DN into a rehabilitation program for shoulder pain in this population.
METHODS


A randomized clinical trial was conducted. Sixteen patients who had suffered a stroke and presented with shoulder pain were randomly assigned to receive rehabilitation alone or rehabilitation combined with DN. Both groups received a neurorehabilitation session including modulatory interventions targeting the central nervous system. Patients in the DN group also received a single session of DN over active TrPs in the shoulder musculature. A numerical pain rating scale (NPRS, 0-10) was used to asses post-needling induced pain at 1 min, 24 h, and 72 h after needling. Shoulder pain (NPRS, 0-10) was assessed at baseline, and 3 and 7 days after DN in both groups.
RESULTS


Five (62%) patients receiving TrP-DN reported post-needling induced pain. Post hoc analysis found that post-needling induced pain decreased significantly at 24 and 72 h (both p < 0.001) after DN. Patients receiving TrP-DN plus rehabilitation exhibited greater decreases in shoulder pain intensity at 3 days (Δ = -4.2, 95% confidence interval (CI) = -5.8 to -2.6) and 7 days (Δ = -4.3, 95% CI = -5.9 to -2.7) after the intervention compared with those receiving rehabilitation alone (all p < 0.001).
CONCLUSION


This trial found that 50% of stroke patients receiving DN experienced post-needling induced pain, a side effect that almost disappeared 72 h after the intervention without any additional therapeutic action. In addition, the inclusion of TrP-DN into a rehabilitation session was effective at decreasing shoulder pain in these patients.",2020,Patients receiving TrP-DN plus rehabilitation exhibited greater decreases in shoulder pain intensity at 3 days (,"['hemiplegic shoulder pain following stroke', 'subjects who had suffered a stroke and received', 'Sixteen patients who had suffered a stroke and presented with shoulder pain']","['trigger point (TrP) dry needling (DN', 'TrP-DN plus rehabilitation', 'rehabilitation alone or rehabilitation combined with DN', 'TrP-DN into a rehabilitation program', 'Post-needling soreness and trigger point dry needling', 'neurorehabilitation session including modulatory interventions targeting the central nervous system']","['shoulder pain', 'shoulder pain intensity', 'pain', 'Shoulder pain (NPRS, 0-10', 'numerical pain rating scale']","[{'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C0458343', 'cui_str': 'Trigger point (body structure)'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0204096', 'cui_str': 'Neurologic Rehabilitation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}]",16.0,0.256772,Patients receiving TrP-DN plus rehabilitation exhibited greater decreases in shoulder pain intensity at 3 days (,"[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Mendigutía-Gómez', 'Affiliation': 'Department of Physical Therapy-Rehabilitation, Hospital Beata María Ana, Madrid, Spain.'}, {'ForeName': 'María T', 'Initials': 'MT', 'LastName': 'Quintana-García', 'Affiliation': 'Department of Physical Therapy-Rehabilitation, Hospital Beata María Ana, Madrid, Spain.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Martín-Sevilla', 'Affiliation': 'Department of Physical Therapy-Rehabilitation, Hospital Beata María Ana, Madrid, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'de Lorenzo-Barrientos', 'Affiliation': 'Instituto Nacional de Estadística, Madrid, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Rodríguez-Jiménez', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation, Universidad Rey Juan Carlos, Alcorcón, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Fernández-de-Las-Peñas', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation, Universidad Rey Juan Carlos, Alcorcón, Spain.'}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Arias-Buría', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation, Universidad Rey Juan Carlos, Alcorcón, Spain.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/0964528419882941']
2763,32004437,Comparison of the Effect of Diclofenac 0.1% and Nepafenac 0.1% on Aqueous Flare in Patients Undergoing Cataract Surgery: A Prospective Randomized Study.,"OBJECTIVES


To compare, using laser flare meter (LFM), the efficacy of topical nepafenac 0.1, % and diclofenac 0.1% ophthalmic solution in the control of anterior chamber inflammation after uncomplicated cataract surgery.
METHODS


Patients undergoing phacoemulsification for age-related cataract were recruited. Complete evaluation with visual acuity, slit-lamp examination, endothelial cell density, intraocular pressure, retinal tomography and anterior chamber flare evaluation was performed before surgery and 1, 15, 30 and 60 days after surgery. Patients were randomly assigned to receive topical diclofenac 0.1% 4 times a day for four weeks or nepafenac 0.1% 3 times a day for three weeks in addition to topical steroids and antibiotic.
RESULTS


64 (31 males, mean age 77.3 ± 5.9) patients were enrolled. Half of them were randomly assigned to group A (diclofenac 0.1%) and half to group B (nepafenac 0.1%). There was a statistically significant visual acuity improvement postoperatively in both groups, with no statistical difference between the groups. Intraocular pressure, corneal thickness, endothelial cells count and macular thickness parameters didn't significantly vary between before and after surgery. One-day after surgery, aqueous flare was significantly higher (22,27 ± 9,25 ph/ms in group A and 22,36 ± 7,47 in group B) than before surgery (14,59 ± 7,16 ph/ms in group A and 11,84 ± 4,44 in group B) in both groups, then declining in the first month and reaching preoperative levels again by 2 months in both groups. In group B, LFM values at 15 and 30 days after surgery were significantly lower (13,59 ± 4,80 and 14,07 ± 5,01) than in group A (17,00 ± 6,97 and 16,96 ± 6,13).
CONCLUSIONS


Nepafenac ensured a better inflammation control than diclofenac during the first month.",2020,"Intraocular pressure, corneal thickness, endothelial cells count and macular thickness parameters didn't significantly vary between before and after surgery.","['Results : 64 (31 males, mean age 77.3 ± 5.9) patients were enrolled', 'anterior chamber inflammation after uncomplicated cataract surgery', 'Patients undergoing phacoemulsification for age-related cataract were recruited', 'Patients Undergoing Cataract Surgery']","['Diclofenac', 'Nepafenac', 'topical diclofenac', 'diclofenac', 'laser flare meter (LFM', 'diclofenac 0.1% ophthalmic solution', 'diclofenac 0.1%) and half to group B (nepafenac 0.1 ', 'nepafenac', 'topical nepafenac']","['aqueous flare', 'Intraocular pressure, corneal thickness, endothelial cells count and macular thickness parameters', 'LFM values', 'visual acuity improvement', 'visual acuity, slit-lamp examination, endothelial cell density, intraocular pressure, retinal tomography and anterior chamber flare evaluation', 'inflammation control']","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1096278', 'cui_str': 'Anterior chamber inflammation'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}]","[{'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0961209', 'cui_str': 'nepafenac'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0029083', 'cui_str': 'Ophthalmic Solution'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}]","[{'cui': 'C0524490', 'cui_str': 'Aqueous Flare'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness (observable entity)'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell count'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0419360', 'cui_str': 'Slit Lamp Examination'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0423281', 'cui_str': 'Anterior chamber flare (finding)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.0320167,"Intraocular pressure, corneal thickness, endothelial cells count and macular thickness parameters didn't significantly vary between before and after surgery.","[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Cagini', 'Affiliation': 'Department of Biomedical and Surgical Sciences, Ophthalmology Section, University of Perugia , Perugia, Italy.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Pellegrino', 'Affiliation': 'Department of Biomedical and Surgical Sciences, Ophthalmology Section, University of Perugia , Perugia, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Cerquaglia', 'Affiliation': 'Department of Biomedical and Surgical Sciences, Ophthalmology Section, University of Perugia , Perugia, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Iaccheri', 'Affiliation': 'Department of Biomedical and Surgical Sciences, Ophthalmology Section, University of Perugia , Perugia, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Lupidi', 'Affiliation': 'Department of Biomedical and Surgical Sciences, Ophthalmology Section, University of Perugia , Perugia, Italy.'}, {'ForeName': 'Tito', 'Initials': 'T', 'LastName': 'Fiore', 'Affiliation': 'Department of Biomedical and Surgical Sciences, Ophthalmology Section, University of Perugia , Perugia, Italy.'}]",Current eye research,['10.1080/02713683.2020.1725061']
2764,31348727,"Improving balance with wobble board exercises in stroke patients: single-blind, randomized clinical trial.","Background : A primary objective in stroke rehabilitation is to restore functional balance, in order to reduce falls. Objectives : To identify the efficacy and safety of wobble board exercises when combined with conventional physiotherapy, in improving balance in hemiplegic patients following ischemic strokes. Methods : A block-randomized, controlled, observer blinded, superiority trial was conducted on ambulatory hemiplegic patients following ischemic strokes of middle cerebral artery territory. Subjects in the control group received a conventional physiotherapy regime. Subjects in the intervention group received training on a wobble board combined with conventional physiotherapy. Main Outcome measures were the improvement of Four-Square Step Test (FSST) and the Berg Balance Scale (BBS), both of which assess functional balance at the end of 6 weeks. Results : Thirty patients were randomly assigned for intervention (n = 15) and control (n = 15) groups. One patient dropped out from the study, leaving 29 eligible for the analysis. Intervention and control groups were comparable in sociodemographic characteristics and pre-test scores of balance. A repeated-measures MANOVA showed a significant difference in improvement of balance between the two study groups after 6 weeks [F(1,28) = 32.6, p  = .000; Wilk's lambda = .46]. The improvement of mean score of balance in interventional group was greater than in the control group [BBS:9.5 (intervention group),5.5 (control group); FSST:3.9 (intervention group),1.7 (control group)]. There were no injuries in both groups. Conclusions : Wobble board exercises, when combined with the conventional physiotherapy, are safe and effective in restoring functional balance in patients with hemiplegia following ischemic strokes.",2019,"Wobble board exercises, when combined with the conventional physiotherapy, are safe and effective in restoring functional balance in patients with hemiplegia following ischemic strokes.","['stroke patients', 'hemiplegic patients following ischemic strokes', 'ambulatory hemiplegic patients following ischemic strokes of middle cerebral artery territory', 'patients with hemiplegia following ischemic strokes', 'Thirty patients']","['wobble board exercises', ' ', 'conventional physiotherapy regime', 'training on a wobble board combined with conventional physiotherapy', 'conventional physiotherapy']","['improvement of balance', 'sociodemographic characteristics and pre-test scores of balance', 'improvement of Four-Square Step Test (FSST) and the Berg Balance Scale (BBS), both of which assess functional balance', 'mean score of balance']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",30.0,0.0979532,"Wobble board exercises, when combined with the conventional physiotherapy, are safe and effective in restoring functional balance in patients with hemiplegia following ischemic strokes.","[{'ForeName': 'Padukka Vidanalage Hasitha', 'Initials': 'PVH', 'LastName': 'Madhuranga', 'Affiliation': 'Department of Allied Health Sciences, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.'}, {'ForeName': 'Yasith', 'Initials': 'Y', 'LastName': 'Mathangasinghe', 'Affiliation': 'Department of Anatomy, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.'}, {'ForeName': 'Dimonge Joseph', 'Initials': 'DJ', 'LastName': 'Anthony', 'Affiliation': 'Department of Allied Health Sciences, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.'}]",Topics in stroke rehabilitation,['10.1080/10749357.2019.1645439']
2765,31366415,Intervening with Attachment and Biobehavioral Catch-Up to decrease disrupted parenting behavior and attachment disorganization: The role of parental withdrawal.,"This randomized controlled trial investigated the efficacy of Attachment and Biobehavioral Catch-up (ABC; Dozier, Bick, & Bernard, 2011) in reducing disrupted parenting behavior (affective communication errors, role/boundary confusion, fearful/disoriented, intrusive/negativity, and withdrawal) and its association with disorganized attachment. Participants were 105 mother-child dyads randomized to receive either ABC or a control intervention (a 10-session home-visiting intervention focused on improving children's cognitive abilities, gross and fine motor abilities, and language development). At the time of study enrollment, mothers were approximately 26.7 years old (SD = 7.8) and predominantly Black or African American (73.9%). At the first follow-up visit, children were approximately 20.7 months old (SD = 6.3) and most were identified as Black or African American (61.9%). Fifty-two percent of children were male (n = 55). Assessments of disrupted parenting behavior and child attachment quality were assessed approximately 7 months postintervention (SD = 5.8). A one-way analysis of variance revealed that parents who received ABC demonstrated lower levels of parental withdrawal than parents who received the control condition. A structural equation model revealed a significant indirect effect of intervention group on attachment quality through lower levels of parental withdrawal. Results add to the efficacy of the ABC intervention and identified parental withdrawal as a mediator of change.",2020,A one-way analysis of variance revealed that parents who received ABC demonstrated lower levels of parental withdrawal than parents who received the control condition.,"['Participants were 105 mother-child dyads', 'mothers were approximately 26.7 years old (SD = 7.8) and predominantly Black or African American (73.9', 'Fifty-two percent of children were male (n = 55']","['ABC intervention', ""ABC or a control intervention (a 10-session home-visiting intervention focused on improving children's cognitive abilities, gross and fine motor abilities, and language development"", 'Attachment and Biobehavioral Catch-up (ABC']","['disrupted parenting behavior and child attachment quality', 'parenting behavior and attachment disorganization']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0023013', 'cui_str': 'Language Development'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0231617', 'cui_str': 'Catch (finding)'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",105.0,0.0318052,A one-way analysis of variance revealed that parents who received ABC demonstrated lower levels of parental withdrawal than parents who received the control condition.,"[{'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Yarger', 'Affiliation': 'Department of Psychology, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Bronfman', 'Affiliation': ""Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Carlson', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dozier', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware, Newark, DE, USA.'}]",Development and psychopathology,['10.1017/S0954579419000786']
2766,31736337,Effects of Sacubitril-Valsartan Versus Valsartan in Women Compared With Men With Heart Failure and Preserved Ejection Fraction: Insights From PARAGON-HF.,"BACKGROUND


Unlike heart failure with reduced ejection fraction, there is no approved treatment for heart failure with preserved ejection fraction, the predominant phenotype in women. Therefore, there is a greater heart failure therapeutic deficit in women compared with men.
METHODS


In a prespecified subgroup analysis, we examined outcomes according to sex in the PARAGON-HF trial (Prospective Comparison of ARNI With ARB Global Outcomes in Heart Failure With Preserved Ejection Fraction), which compared sacubitril-valsartan and valsartan in patients with heart failure with preserved ejection fraction. The primary outcome was a composite of first and recurrent hospitalizations for heart failure and death from cardiovascular causes. We also report secondary efficacy and safety outcomes.
RESULTS


Overall, 2479 women (51.7%) and 2317 men (48.3%) were randomized. Women were older and had more obesity, less coronary disease, and lower estimated glomerular filtration rate and NT-proBNP (N-terminal pro-B-type natriuretic peptide) levels than men. For the primary outcome, the rate ratio for sacubitril-valsartan versus valsartan was 0.73 (95% CI, 0.59-0.90) in women and 1.03 (95% CI, 0.84-1.25) in men ( P  interaction = 0.017). The benefit from sacubitril-valsartan was attributable to reduction in heart failure hospitalization. The improvement in New York Heart Association class and renal function with sacubitril-valsartan was similar in women and men, whereas the improvement in Kansas City Cardiomyopathy Questionnaire clinical summary score was less in women than in men. The difference in adverse events between sacubitril-valsartan and valsartan was similar in women and men.
CONCLUSIONS


As compared with valsartan, sacubitril-valsartan seemed to reduce the risk of heart failure hospitalization more in women than in men. Whereas the possible sex-related modification of the effect of treatment has several potential explanations, the present study does not provide a definite mechanistic basis for this finding.
CLINICAL TRIAL REGISTRATION


https://www.clinicaltrials.gov. Unique identifier: NCT01920711.",2020,"Women were older, had more obesity, less coronary disease, and lower estimated glomerular filtration rate and NT-proBNP levels than men.","['Women Compared to Men with Heart Failure and Preserved Ejection Fraction', 'patients with HFpEF', '2479 women (51.7%) and 2317 men (48.3%) were randomized']","['Valsartan', 'valsartan', 'Sacubitril-Valsartan', 'sacubitril-valsartan and valsartan', 'sacubitril-valsartan']","['adverse events', 'rate ratio for sacubitril-valsartan versus valsartan', 'glomerular filtration rate and NT-proBNP levels', 'risk of heart failure hospitalization', 'KCCQ-CSS', 'NYHA class and renal function', 'composite of first and recurrent hospitalizations for heart failure and death from cardiovascular causes', 'heart failure hospitalization']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}]",2479.0,0.248688,"Women were older, had more obesity, less coronary disease, and lower estimated glomerular filtration rate and NT-proBNP levels than men.","[{'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, UK (J.J.V.M., A.M.J., P.S.J.).'}, {'ForeName': 'Alice M', 'Initials': 'AM', 'LastName': 'Jackson', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, UK (J.J.V.M., A.M.J., P.S.J.).'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Center Singapore and Duke-National University of Singapore (C.S.P.L.).'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Redfield', 'Affiliation': 'Mayo Clinic, Rochester, MN (M.M.R.).'}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'University of Minnesota, Minneapolis (I.S.A.).'}, {'ForeName': 'Junbo', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, China (J.G.).'}, {'ForeName': 'Marty P', 'Initials': 'MP', 'LastName': 'Lefkowitz', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ (M.P.L., A.R.R., S.V.S., V.C.S.).'}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'National Association of Hospital Cardiologists Research Center, Florence, Italy (A.P.M.).'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Martinez', 'Affiliation': 'National University of Cordoba, Argentina (F.M.).'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor University Medical Center, Dallas, TX (M.P.).'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.A.P., A.M.S., B.C., S.D.S.).""}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Department of Internal Medicine and Cardiology, German Center for Cardiovascular Research Partner Site Berlin, Germany (B.P.).'}, {'ForeName': 'Adel R', 'Initials': 'AR', 'LastName': 'Rizkala', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ (M.P.L., A.R.R., S.V.S., V.C.S.).'}, {'ForeName': 'Shalini V', 'Initials': 'SV', 'LastName': 'Sabarwal', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ (M.P.L., A.R.R., S.V.S., V.C.S.).'}, {'ForeName': 'Amil M', 'Initials': 'AM', 'LastName': 'Shah', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.A.P., A.M.S., B.C., S.D.S.).""}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (S.J.S.).'}, {'ForeName': 'Victor C', 'Initials': 'VC', 'LastName': 'Shi', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ (M.P.L., A.R.R., S.V.S., V.C.S.).'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Veldhuisen', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, The Netherlands (C.S.P.L., D.J.v.V.).'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""INSERM Centre d'Investigation Clinic 1433 and Universite de Lorraine, Centre Hospitalier Regional et Universitaire, Nancy, France (F.Z.).""}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Zile', 'Affiliation': 'Medical University of South Carolina and the Ralph H. Johnson Department of Veterans Affairs Medical Center, Charleston (M.R.Z.).'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Cikes', 'Affiliation': 'Department of Cardiovascular Diseases, University of Zagreb School of Medicine and University Hospital Centre Zagreb, Croatia (M.C.).'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Goncalvesova', 'Affiliation': 'Department of Heart Failure-Transplantation, National Cardiovascular Institute, Bratislava, Slovakia (E.G.).'}, {'ForeName': 'Tzvetana', 'Initials': 'T', 'LastName': 'Katova', 'Affiliation': 'Clinic of Cardiology, National Cardiology Hospital, Sofia, Bulgaria (T.K.).'}, {'ForeName': 'Anamaria', 'Initials': 'A', 'LastName': 'Kosztin', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary (A.K.).'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Lelonek', 'Affiliation': 'Department of Noninvasive Cardiology, Medical University of Lodz, Poland (M.L.).'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Sweitzer', 'Affiliation': 'University of Arizona Sarver Heart, Tucson (N.S.).'}, {'ForeName': 'Orly', 'Initials': 'O', 'LastName': 'Vardeny', 'Affiliation': 'Minneapolis VA Center for Care Delivery and Outcomes Research, University of Minnesota (O.V.).'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.A.P., A.M.S., B.C., S.D.S.).""}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, UK (J.J.V.M., A.M.J., P.S.J.).'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.A.P., A.M.S., B.C., S.D.S.).""}]",Circulation,['10.1161/CIRCULATIONAHA.119.044491']
2767,31707795,"Evaluating the Effects of Canagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes Mellitus and Chronic Kidney Disease According to Baseline HbA1c, Including Those With HbA1c <7%: Results From the CREDENCE Trial.",,2020,,['Patients With Type 2 Diabetes Mellitus and Chronic Kidney Disease'],['Canagliflozin'],['Cardiovascular and Renal Events'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.0294316,,"[{'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Cardiovascular Division, Brigham & Women's Hospital and Baim Institute for Clinical Research, Boston, MA (C.P.C.).""}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Australia (V.P., H.J.L.H, M.J.J., J.-W.L., B.N.).'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Indiana University School of Medicine and VA Medical Center, Indianapolis (R.A.).'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Baldassarre', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ (J.B., R.E.).'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Bakris', 'Affiliation': 'Department of Medicine, University of Chicago Medicine, IL (G.B.).'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Charytan', 'Affiliation': 'Nephrology Division, NYU School of Medicine and NYU Langone Medical Center (D.M.C.).'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'de Zeeuw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, The Netherlands (D.d.Z., H.J.L.H.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Edwards', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ (J.B., R.E.).'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'Division of Biostatistics, Department of Population Health Sciences, University of Utah, Salt Lake City (T.G.).'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Australia (V.P., H.J.L.H, M.J.J., J.-W.L., B.N.).'}, {'ForeName': 'Meg J', 'Initials': 'MJ', 'LastName': 'Jardine', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Australia (V.P., H.J.L.H, M.J.J., J.-W.L., B.N.).'}, {'ForeName': 'Adeera', 'Initials': 'A', 'LastName': 'Levin', 'Affiliation': 'Division of Nephrology, University of British Columbia, Vancouver, Canada (A.L.).'}, {'ForeName': 'Jing-Wei', 'Initials': 'JW', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Australia (V.P., H.J.L.H, M.J.J., J.-W.L., B.N.).'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Australia (V.P., H.J.L.H, M.J.J., J.-W.L., B.N.).'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Pollock', 'Affiliation': 'Kolling Institute of Medical Research, Sydney Medical School, University of Sydney, Royal North Shore Hospital, St Leonards, New South Wales, Australia (C.P.).'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'Department of Renal Medicine, UCL Medical School, London, United Kingdom (D.C.W.).'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Renal Division of Peking University First Hospital, Beijing, China (H.Z.).'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mt Sinai Hospital, University of Toronto, Ontario, Canada (B.Z.).'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, CA (K.W.M.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.044359']
2768,32005340,Internet-Based Cognitive Behavior Therapy for Loneliness: A Pilot Randomized Controlled Trial.,"Loneliness has been described as a common source of discomfort based on a subjective discrepancy between the actual and desired social situation. For some people this feeling may become a sustained state that is associated with a wide range of psychiatric and psychosocial problems. While there are few existing treatment protocols, interventions based on cognitive behavioral therapy (CBT) have shown positive effects. The current study investigated the efficacy of an 8-week internet-based treatment containing CBT components aimed at reducing feelings of loneliness. Seventy-three participants were recruited from the general public and randomly allocated to treatment or a wait-list control condition. Participants were assessed with standardized self-report measures of loneliness, depression, social anxiety, worry, and quality of life at pretreatment and posttreatment. Robust linear regression analysis of all randomized participants showed significant treatment effects on the primary outcome measure of loneliness (between group Cohen's d = 0.77), and on secondary outcomes measuring quality of life and social anxiety relative to control at postassessment. The results suggest the potential utility of internet-based CBT in alleviating loneliness but more research on the long-term effects and the mechanisms underlying the effects is needed.",2020,"Robust linear regression analysis of all randomized participants showed significant treatment effects on the primary outcome measure of loneliness (between group Cohen's d = 0.77), and on secondary outcomes measuring quality of life and social anxiety relative to control at postassessment.","['Loneliness', 'Seventy-three participants were recruited from the general public']","['internet-based CBT', 'cognitive behavioral therapy (CBT', 'wait-list control condition', 'Internet-Based Cognitive Behavior Therapy']","['feelings of loneliness', 'loneliness', 'quality of life and social anxiety relative', 'standardized self-report measures of loneliness, depression, social anxiety, worry, and quality of life']","[{'cui': 'C0023974', 'cui_str': 'Loneliness'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0023974', 'cui_str': 'Loneliness'}, {'cui': 'C0034380'}, {'cui': 'C0424166', 'cui_str': 'Social Anxiety'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}]",73.0,0.0685848,"Robust linear regression analysis of all randomized participants showed significant treatment effects on the primary outcome measure of loneliness (between group Cohen's d = 0.77), and on secondary outcomes measuring quality of life and social anxiety relative to control at postassessment.","[{'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Käll', 'Affiliation': 'Linköping University.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Jägholm', 'Affiliation': 'Linköping University.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Hesser', 'Affiliation': 'Linköping University.'}, {'ForeName': 'Frida', 'Initials': 'F', 'LastName': 'Andersson', 'Affiliation': 'Linköping University.'}, {'ForeName': 'Aleksi', 'Initials': 'A', 'LastName': 'Mathaldi', 'Affiliation': 'Linköping University.'}, {'ForeName': 'Beatrice Tiger', 'Initials': 'BT', 'LastName': 'Norkvist', 'Affiliation': 'Linköping University.'}, {'ForeName': 'Roz', 'Initials': 'R', 'LastName': 'Shafran', 'Affiliation': 'University College London.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Linköping University; Karolinska Institute. Electronic address: gerhard.andersson@liu.se.'}]",Behavior therapy,['10.1016/j.beth.2019.05.001']
2769,20305034,No protection of the ovarian follicle pool with the use of GnRH-analogues or oral contraceptives in young women treated with escalated BEACOPP for advanced-stage Hodgkin lymphoma. Final results of a phase II trial from the German Hodgkin Study Group.,"BACKGROUND


The reduction of treatment-related toxic effects is the main goal in the current trials of the German Hodgkin Study Group (GHSG). In this regard, the protection of the ovarian reserve in young women is very important. Therefore, the GHSG investigated the use of gonadotropin-releasing hormone-analogues (GnRH-a) and oral contraceptives (OC) in young women with advanced-stage Hodgkin lymphoma (HL).
PATIENTS AND METHODS


Women (18-40 years) were randomly assigned either to receive daily OC or monthly GnRH-a during escalated combination therapy with bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPPesc). Hormonal levels were determined at baseline, during therapy, and at follow-up.
RESULTS


The study was closed prematurely after an interim analysis of 12 patients in arm A (OC) and 11 in arm B (GnRH-a), 9 and 10 are assessable for the primary end point. Women's median age was 25 years in both arms. The anti-Mullerian hormone level after at least 12 months was reduced in all patients. For the entire study cohort, the respective ovarian follicle preservation rate was 0% (95% confidence interval 0% to 12%).
CONCLUSION


We observed no protection of the ovarian reserve with hormonal co-treatment during BEACOPPesc. This result supports efforts of ongoing trials to reduce chemotherapy intensity and toxicity. Alternative strategies for the protection of fertility must be offered to young female HL patients before the start of BEACOPPesc therapy.",2010,We observed no protection of the ovarian reserve with hormonal co-treatment during BEACOPPesc.,"['young female HL patients before the start of BEACOPPesc therapy', 'young women', ""Women's median age was 25 years in both arms"", '12 patients in arm A (OC) and 11 in arm B (GnRH-a), 9 and 10 are assessable for the primary end point', 'young women with advanced-stage Hodgkin lymphoma (HL', 'Women (18-40 years', 'young women treated with escalated BEACOPP for advanced-stage Hodgkin lymphoma']","['gonadotropin-releasing hormone-analogues (GnRH-a) and oral contraceptives (OC', 'daily OC or monthly GnRH-a during escalated combination therapy with bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPPesc', 'GnRH-analogues or oral contraceptives']","['Hormonal levels', 'respective ovarian follicle preservation rate', 'anti-Mullerian hormone level']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms (body structure)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0303135', 'cui_str': '10Be radioisotope'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues, endocrine therapy drugs'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0029151', 'cui_str': 'Oral contraception (finding)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0085752', 'cui_str': 'Adriamycin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0033223', 'cui_str': 'Procarbazine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0018120', 'cui_str': 'Ovarian Follicle'}, {'cui': 'C4048548', 'cui_str': 'Anti-Mullerian hormone level'}]",,0.0457998,We observed no protection of the ovarian reserve with hormonal co-treatment during BEACOPPesc.,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Behringer', 'Affiliation': 'German Hodgkin Study Group, First Department of Internal Medicine, University Hospital Cologne, Cologne, Germany. Electronic address: karolin.behringer@uk-koeln.de.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wildt', 'Affiliation': 'University Hospital for Gynecology and Reproduction Medicine.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Mueller', 'Affiliation': 'German Hodgkin Study Group, First Department of Internal Medicine, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Mattle', 'Affiliation': 'University Hospital for Gynecology and Reproduction Medicine.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ganitis', 'Affiliation': 'German Hodgkin Study Group, First Department of Internal Medicine, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'van den Hoonaard', 'Affiliation': 'German Hodgkin Study Group, First Department of Internal Medicine, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'H W', 'Initials': 'HW', 'LastName': 'Ott', 'Affiliation': 'Institute of Medical and Chemical Laboratory Diagnostics (ZIMCL), University Hospital Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hofer', 'Affiliation': 'Institute of Medical and Chemical Laboratory Diagnostics (ZIMCL), University Hospital Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pluetschow', 'Affiliation': 'German Hodgkin Study Group, First Department of Internal Medicine, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Diehl', 'Affiliation': 'German Hodgkin Study Group, First Department of Internal Medicine, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Engert', 'Affiliation': 'German Hodgkin Study Group, First Department of Internal Medicine, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Borchmann', 'Affiliation': 'German Hodgkin Study Group, First Department of Internal Medicine, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq066']
2770,20332134,The influence of sex and histology on outcomes in non-small-cell lung cancer: a pooled analysis of five randomized trials.,"BACKGROUND


Some non-small-cell lung cancer (NSCLC) surgical series have indicated that the positive prognostic effect of female sex is limited to patients with adenocarcinoma. We carried out a retrospective analysis to investigate the role of sex and histology on efficacy, toxicity, and dose delivery after chemotherapy.
PATIENT AND METHODS


Individual patient data were pooled from five randomized, phase III, advanced NSCLC chemotherapy trials. Primary outcomes were response rate, overall survival (OS), toxicity, and dose delivery. A secondary analysis examined survival by sex in histological subgroups.
RESULTS


Of 2349 patients, 34% were women. Women had a higher response rate to chemotherapy (42% versus 40%, P = 0.01) and longer survival than men (median OS 9.6 versus 8.6 months, P = 0.002). The difference in OS remained after adjusting for age, stage, performance status, and histology (hazard ratio 0.83, 95% confidence interval 0.74-0.92, P = 0.0005). Upon further examination, longer survival in women was only seen in patients with adenocarcinoma (test for interaction P = 0.006). There were no differences in hematological toxicity or transfusions. Women experienced more grade 3-4 emesis than men (P < 0.0001) and more dose delays (P = 0.02) or dose reductions (P < 0.0001).
CONCLUSION


The positive prognostic effect among women is confirmed in patients receiving platinum-based chemotherapy but appears confined to those with adenocarcinoma histology.",2010,"Women experienced more grade 3-4 emesis than men (P < 0.0001) and more dose delays (P = 0.02) or dose reductions (P < 0.0001).
","['non-small-cell lung cancer', 'patients with adenocarcinoma', 'Of 2349 patients, 34% were women', 'Individual patient data were pooled from five randomized, phase III, advanced NSCLC chemotherapy trials']",['platinum-based chemotherapy'],"['response rate to chemotherapy', 'grade 3-4 emesis', 'response rate, overall survival (OS), toxicity, and dose delivery', 'OS', 'efficacy, toxicity', 'longer survival', 'hematological toxicity or transfusions']","[{'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}]",2349.0,0.357293,"Women experienced more grade 3-4 emesis than men (P < 0.0001) and more dose delays (P = 0.02) or dose reductions (P < 0.0001).
","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Wheatley-Price', 'Affiliation': 'Princess Margaret Hospital/University Health Network, Toronto, Ontario, Canada. Electronic address: pwheatleyprice@toh.on.ca.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Blackhall', 'Affiliation': 'Christie Hospital, Manchester.'}, {'ForeName': 'S-M', 'Initials': 'SM', 'LastName': 'Lee', 'Affiliation': 'University College Hospital, London.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Princess Margaret Hospital/University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ashcroft', 'Affiliation': 'Christie Hospital, Manchester.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jitlal', 'Affiliation': 'Cancer Research UK and University College London Cancer Trials Centre, London.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Qian', 'Affiliation': 'Medical Research Council Clinical Trials Unit, London.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hackshaw', 'Affiliation': 'Cancer Research UK and University College London Cancer Trials Centre, London.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Rudd', 'Affiliation': ""St Bartholomew's Hospital, London.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Booton', 'Affiliation': 'Christie Hospital, Manchester.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Danson', 'Affiliation': 'Weston Park Hospital, Sheffield, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lorigan', 'Affiliation': 'Christie Hospital, Manchester.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Thatcher', 'Affiliation': 'Christie Hospital, Manchester.'}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'Shepherd', 'Affiliation': 'Princess Margaret Hospital/University Health Network, Toronto, Ontario, Canada.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq067']
2771,20335368,Quality of life of patients receiving platinum-based chemotherapy plus cetuximab first line for recurrent and/or metastatic squamous cell carcinoma of the head and neck.,"BACKGROUND


A phase III trial demonstrated that cetuximab is the first agent in 30 years to improve survival when added to platinum-based chemotherapy (platinum-fluorouracil) first line for recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). This analysis of the trial assessed the impact of treatment on quality of life (QoL).
PATIENTS AND METHODS


The European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30 (QLQ-C30) and QLQ-Head and Neck 35 (QLQ-H&N35) module were used to assess QoL.
RESULTS


Of 442 patients randomly assigned, 291 (QLQ-C30) and 289 (QLQ-H&N35) patients completed at least one evaluable questionnaire. For QLQ-C30, cycle 3 and month 6 mean scores for platinum-fluorouracil plus cetuximab were not significantly worse than those for platinum-fluorouracil. Pattern-mixture analysis demonstrated a significant improvement in the global health status/QoL score in the cetuximab arm (P = 0.0415) but no treatment differences in the social functioning scale. For QLQ-H&N35, the mean score for the cetuximab arm was not significantly worse than that for the chemotherapy arm for all symptom scales at all post-baseline visits. At cycle 3, some symptom scores significantly favored the cetuximab arm (pain, swallowing, speech problems, and social eating).
CONCLUSION


Adding cetuximab to platinum-fluorouracil does not adversely affect the QoL of patients with recurrent and/or metastatic SCCHN.",2010,Adding cetuximab to platinum-fluorouracil does not adversely affect the QoL of patients with recurrent and/or metastatic SCCHN.,"['recurrent and/or metastatic squamous cell carcinoma of the head and neck', '442 patients randomly assigned, 291 (QLQ-C30) and 289 (QLQ-H&N35) patients completed at least one evaluable questionnaire', 'patients with recurrent and/or metastatic SCCHN', 'recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN']","['cetuximab to platinum-fluorouracil', 'platinum-based chemotherapy (platinum-fluorouracil', 'platinum-based chemotherapy plus cetuximab first line', 'platinum-fluorouracil', 'cetuximab', 'platinum-fluorouracil plus cetuximab']","['Quality of life', 'social functioning scale', 'global health status/QoL score', 'cetuximab arm (pain, swallowing, speech problems, and social eating', 'quality of life (QoL']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C2585826', 'cui_str': 'Social functioning scale (assessment scale)'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011167', 'cui_str': 'Swallowing'}, {'cui': 'C0395016', 'cui_str': 'Speech problem (finding)'}]",442.0,0.0301589,Adding cetuximab to platinum-fluorouracil does not adversely affect the QoL of patients with recurrent and/or metastatic SCCHN.,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mesía', 'Affiliation': 'Department of Medical Oncology, Catalan Institute of Oncology, Hospitalet de Llobregat, Barcelona, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rivera', 'Affiliation': 'Medical Oncology Department, Marqués de Valdecilla University Hospital, Santander, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kawecki', 'Affiliation': 'Head and Neck Cancer Department, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rottey', 'Affiliation': 'Medical Oncology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hitt', 'Affiliation': ""Medical Oncology Department, University Hospital '12 de Octubre', Madrid, Spain.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kienzer', 'Affiliation': '3rd Medical Department, Kaiser Franz Josef Spital, Ludwig Boltzmann Institute for Applied Cancer Research, Vienna, Austria.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cupissol', 'Affiliation': ""Department of Medical Oncology, Val d'Aurelle-Paul Lamarque Regional Cancer Centre, Montpellier, France.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'De Raucourt', 'Affiliation': 'Head and Neck Unit, François Baclesse Centre, Caen, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Benasso', 'Affiliation': 'Oncology Department, San Paolo Hospital, Savona Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Koralewski', 'Affiliation': 'Oncology, Rydygier Memorial Hospital, Krakow-Nowa Huta, Poland.'}, {'ForeName': 'J-P', 'Initials': 'JP', 'LastName': 'Delord', 'Affiliation': 'Department of Medical Oncology, Claudius Regaud Institute, Toulouse, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bokemeyer', 'Affiliation': 'Department of Oncology, Hematology, BMT with section Pneumology, Hubertus Wald Tumorzentrum, University Cancer Center Hamburg, University Hospital, Hamburg, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Curran', 'Affiliation': 'Statistics, OMEGA Research, Santry, Dublin, Ireland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gross', 'Affiliation': 'Global Statistics, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Vermorken', 'Affiliation': 'Department of Medical Oncology, Antwerp University Hospital, Edegem, Belgium. Electronic address: jan.b.vermorken@uza.be.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq077']
2772,19940014,"Fentanyl buccal soluble film (FBSF) for breakthrough pain in patients with cancer: a randomized, double-blind, placebo-controlled study.","BACKGROUND


Fentanyl buccal soluble film (FBSF) has been developed as a treatment of breakthrough pain in opioid-tolerant patients with cancer. The objective of this study was to evaluate the efficacy of FBSF at doses of 200-1200 microg in the management of breakthrough pain in patients with cancer receiving ongoing opioid therapy.
PATIENTS AND METHODS


This was a multicenter, randomized, double-blind, placebo-controlled, multiple-crossover study that included opioid-tolerant adult patients with chronic cancer pain who experienced one to four daily episodes of breakthrough pain. The primary efficacy assessment was the sum of pain intensity differences at 30 min (SPID30) postdose.
RESULTS


The intent-to-treat population consisted of 80 patients with > or =1 post-baseline efficacy assessment. The least-squares mean (LSM +/- SEM) of the SPID30 was significantly greater for FBSF-treated episodes of breakthrough pain than for placebo-treated episodes (47.9 +/- 3.9 versus 38.1 +/- 4.3; P = 0.004). There was statistical separation from placebo starting at 15 min up through 60 min (last time point assessed). There were no unexpected adverse events (AEs) or clinically significant safety findings.
CONCLUSIONS


FBSF is an effective option for control of breakthrough pain in patients receiving ongoing opioid therapy. In this study, FBSF was well tolerated in the oral cavity, with no reports of treatment-related oral AEs.",2010,SEM) of the SPID30 was significantly greater for FBSF-treated episodes of breakthrough pain than for placebo-treated episodes (47.9 +/-,"['adult patients with chronic cancer pain who experienced one to four daily episodes of breakthrough pain', 'opioid-tolerant patients with cancer', 'patients receiving ongoing opioid therapy', 'patients with cancer receiving ongoing opioid therapy', 'patients with cancer']","['FBSF', 'Fentanyl buccal soluble film (FBSF', 'placebo', 'opioid-tolerant']","['least-squares mean (LSM ', 'sum of pain intensity differences at 30 min (SPID30) postdose']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C1135120', 'cui_str': 'Breakthrough Pain'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]","[{'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]",80.0,0.424308,SEM) of the SPID30 was significantly greater for FBSF-treated episodes of breakthrough pain than for placebo-treated episodes (47.9 +/-,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Rauck', 'Affiliation': 'Carolinas Pain Institute, Winston-Salem, NC.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'North', 'Affiliation': 'Carolinas Pain Institute, Winston-Salem, NC.'}, {'ForeName': 'L N', 'Initials': 'LN', 'LastName': 'Gever', 'Affiliation': 'Meda Pharmaceuticals, Inc., Somerset, NJ, USA.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Tagarro', 'Affiliation': 'Meda Pharmaceuticals, Madrid, Spain.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Finn', 'Affiliation': 'BioDelivery Sciences International, Inc., Raleigh, NC, USA. Electronic address: afinn@bdsinternational.com.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp541']
2773,19917571,"Multicentre phase I/II study of PI-88, a heparanase inhibitor in combination with docetaxel in patients with metastatic castrate-resistant prostate cancer.","BACKGROUND


Docetaxel (Taxotere) improve survival and prostate-specific antigen (PSA) response rates in patients with metastatic castrate-resistant prostate cancer (CRPC). We studied the combination of PI-88, an inhibitor of angiogenesis and heparanase activity, and docetaxel in chemotherapy-naive CRPC.
PATIENTS AND METHODS


We conducted a multicentre open-label phase I/II trial of PI-88 in combination with docetaxel. The primary end point was PSA response. Secondary end points included toxicity, radiologic response and overall survival. Doses of PI-88 were escalated to the maximum tolerated dose; whereas docetaxel was given at a fixed 75 mg/m(2) dose every three weeks
RESULTS


Twenty-one patients were enrolled in the dose-escalation component. A further 35 patients were randomly allocated to the study to evaluate the two schedules in phase II trial. The trial was stopped early by the Safety Data Review Board due to a higher-than-expected febrile neutropenia of 27%. In the pooled population, the PSA response (50% reduction) was 70%, median survival was 61 weeks (6-99 weeks) and 1-year survival was 71%.
CONCLUSIONS


The regimen of docetaxel and PI-88 is active in CRPC but associated with significant haematologic toxicity. Further evaluation of different scheduling and dosing of PI-88 and docetaxel may be warranted to optimise efficacy with a more manageable safety profile.",2010,"In the pooled population, the PSA response (50% reduction) was 70%, median survival was 61 weeks (6-99 weeks) and 1-year survival was 71%.
","['35 patients', 'Twenty-one patients were enrolled in the dose-escalation component', 'patients with metastatic castrate-resistant prostate cancer (CRPC', 'patients with metastatic castrate-resistant prostate cancer']","['docetaxel', 'Docetaxel (Taxotere', 'PI-88, a heparanase inhibitor in combination with docetaxel', 'PI-88 and docetaxel']","['toxicity, radiologic response and overall survival', 'PSA response', 'median survival', 'haematologic toxicity', 'febrile neutropenia', '1-year survival', 'survival and prostate-specific antigen (PSA) response rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0699967', 'cui_str': 'Taxotere'}, {'cui': 'C1533712', 'cui_str': 'PI88 cpd'}, {'cui': 'C0062505', 'cui_str': 'heparan sulphate endoglycosidase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205483', 'cui_str': 'Radiologic (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}]",21.0,0.0371213,"In the pooled population, the PSA response (50% reduction) was 70%, median survival was 61 weeks (6-99 weeks) and 1-year survival was 71%.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Khasraw', 'Affiliation': 'Department of Oncology, Royal North Shore Hospital. Electronic address: mkhasraw@med.usyd.edu.au.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Pavlakis', 'Affiliation': 'Department of Oncology, Royal North Shore Hospital.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'McCowatt', 'Affiliation': 'Department of Oncology, Royal North Shore Hospital; Sydney New South Wales Haematology and Oncology Clinics, Sydney, New South Wales.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Underhill', 'Affiliation': 'Border Medical Oncology, Wodonga, Victoria.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Begbie', 'Affiliation': 'Department of Oncology, Port Macquarie Base Hospital, Port Macquarie.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'de Souza', 'Affiliation': 'UNSW, St George Hospital Clinical School, Sydney.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Boyce', 'Affiliation': 'Department of Oncology, Lismore Base Hospital, Lismore, New South Wales.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Parnis', 'Affiliation': 'Ashford Cancer Centre, Adelaide, South Australia, Australia.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Lim', 'Affiliation': 'Department of Oncology, Royal North Shore Hospital.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Harvie', 'Affiliation': 'Department of Oncology, Royal North Shore Hospital.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Marx', 'Affiliation': 'Department of Oncology, Royal North Shore Hospital; Sydney New South Wales Haematology and Oncology Clinics, Sydney, New South Wales.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp524']
2774,20335369,Effects of CERA (continuous erythropoietin receptor activator) in patients with advanced non-small-cell lung cancer (NSCLC) receiving chemotherapy: results of a phase II study.,"BACKGROUND


Continuous erythropoietin receptor activator (CERA; methoxy polyethylene glycol-epoetin beta) is a new erythropoiesis-stimulating agent with a prolonged half-life. The objective of this study was to select a starting dose of CERA for the treatment of anemia in non-small-cell lung cancer (NSCLC) patients.
PATIENTS AND METHODS


The study was an open-label randomized phase II trial containing four treatment groups of patients with anemia and stage IIIB or IV NSCLC. The fourth treatment group was a reference group of patients treated with darbepoetin alfa administered at either 6.75 μg/kg s.c. every 3 weeks or 2.25 μg/kg weekly. Due to observed imbalances in death across treatment arms, this study was prematurely terminated.
RESULTS


The primary efficacy parameter of the mean hemoglobin (Hb) change from baseline during weeks 5-13 was +0.03 g/dl, +0.50 g/dl, and -0.02 g/dl in the CERA 6.3, 9, and 12 μg/kg dose groups, respectively, and +0.26 g/dl in the darbepoetin alfa dose group (P value not significant for all three study arms). Eight (21%), 12 (32%), 9 (24%), and 4 (10%) patients in the CERA 6.3, 9, and 12 μg/kg and darbepoetin groups, respectively, died.
CONCLUSION


In this phase II study in patients with stage IIIB or IV NSCLC receiving chemotherapy, none of the four treatment arms showed an adequate increase in mean Hb level.",2010,"(Hb) change from baseline during weeks 5-13 was +0.03 g/dl, +0.50 g/dl, and -0.02 g/dl in the CERA 6.3, 9, and 12 μg/kg dose groups, respectively, and +0.26 g/dl in the darbepoetin alfa dose group (P value not significant for all three study arms).","['patients with advanced non-small-cell lung cancer', 'patients with anemia and stage IIIB or IV NSCLC', 'patients with stage IIIB or IV NSCLC receiving', 'anemia in non-small-cell lung cancer (NSCLC) patients']","['darbepoetin alfa', 'erythropoietin receptor activator (CERA; methoxy polyethylene glycol-epoetin beta', 'chemotherapy', 'CERA', 'CERA (continuous erythropoietin receptor activator']","['mean Hb level', 'mean hemoglobin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}]","[{'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}, {'cui': 'C0059570', 'cui_str': 'Erythropoietin Receptor'}, {'cui': 'C1328071', 'cui_str': 'Methoxy polyethylene glycol-epoetin beta'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4521598', 'cui_str': 'Continuous erythropoietin receptor activator'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.0630391,"(Hb) change from baseline during weeks 5-13 was +0.03 g/dl, +0.50 g/dl, and -0.02 g/dl in the CERA 6.3, 9, and 12 μg/kg dose groups, respectively, and +0.26 g/dl in the darbepoetin alfa dose group (P value not significant for all three study arms).","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gascon', 'Affiliation': 'Division of Medical Oncology, Hospital Clinic Provincial, Barcelona, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pirker', 'Affiliation': 'Department of Medicine I, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Del Mastro', 'Affiliation': 'Department of Medical Oncology, Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Durrwell', 'Affiliation': 'Clinical Science-Anemia, Hoffmann-La Roche Ltd, Basel, Switzerland. Electronic address: laurence.durrwell@roche.com.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq073']
2775,31986897,Benefits of dry needling of myofascial trigger points on autonomic function and photoelectric plethysmography in patients with fibromyalgia syndrome.,"BACKGROUND


Fibromyalgia syndrome (FMS) is a condition characterised by the presence of chronic, widespread musculoskeletal pain, low pain threshold and hyperalgesia. Myofascial trigger points (MTrPs) may worsen symptoms in patients with FMS.
OBJECTIVE


The purpose of this randomised controlled trial was to compare the effects of dry needling and transcutaneous electrical nerve stimulation (TENS) on pain intensity, heart rate variability, galvanic response and oxygen saturation (SpO 2 ).
METHODS


74 subjects with FMS were recruited and randomly assigned to either the dry needling group or the TENS group. Outcomes measures (pain intensity, heart rate variability, galvanic skin response, SpO 2  and photoplethysmography) were evaluated at baseline and after 6 weeks of treatment. 2×2 mixed-model analyses of variance (ANOVAs) were performed.
RESULTS


The mixed-model ANOVAs showed significant differences between groups for the sensory dimension of pain, affective dimension of pain, total dimension of pain, visual analogue scale (VAS) and present pain intensity (PPI) (P=0.001). ANOVAs also showed that significant differences between groups were achieved for very low frequency power of heart rate variability (P=0.008) and low frequency power (P=0.033). There were no significant differences in dry needling versus TENS groups on the spectral analysis of the photoplethysmography and SpO 2 .
CONCLUSIONS


This trial showed that application of dry needling therapy and TENS reduced pain attributable to MTrPs in patients with FMS, with greater improvements reported in the dry needling group across all dimensions of pain. Additionally, there were between-intervention differences for several parameters of heart rate variability and galvanic skin responses.
TRIAL REGISTRATION NUMBER


NCT02393352.",2020,"There were no significant differences in dry needling versus TENS groups on the spectral analysis of the photoplethysmography and SpO 2 .
","['patients with fibromyalgia syndrome', 'patients with FMS', '74 subjects with FMS']","['dry needling of myofascial trigger points', 'dry needling and transcutaneous electrical nerve stimulation (TENS', 'dry needling group or the TENS']","['sensory dimension of pain, affective dimension of pain, total dimension of pain, visual analogue scale (VAS) and present pain intensity (PPI', 'Outcomes measures (pain intensity, heart rate variability, galvanic skin response, SpO 2  and photoplethysmography', 'heart rate variability and galvanic skin responses', 'pain intensity, heart rate variability, galvanic response and oxygen saturation (SpO 2 ', 'autonomic function and photoelectric plethysmography', 'pain attributable to MTrPs', 'heart rate variability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture (procedure)'}, {'cui': 'C0458343', 'cui_str': 'Trigger point (body structure)'}, {'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}]","[{'cui': 'C1286322', 'cui_str': 'Sensory dimension of pain'}, {'cui': 'C1286323', 'cui_str': 'Affective dimension of pain'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0016989', 'cui_str': 'Reflex, Psychogalvanic'}, {'cui': 'C0162599', 'cui_str': 'Light Reflection Rheography'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}]",74.0,0.0597644,"There were no significant differences in dry needling versus TENS groups on the spectral analysis of the photoplethysmography and SpO 2 .
","[{'ForeName': 'Adelaida María', 'Initials': 'AM', 'LastName': 'Castro-Sánchez', 'Affiliation': 'Department of Nursing, Physical Therapy and Medicine, University of Almeria, Almeria, Spain.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Garcia-López', 'Affiliation': 'Andalusian Health Service, Hospital de Poniente, Almeria, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Fernández-Sánchez', 'Affiliation': 'Department of Nursing, Physical Therapy and Medicine, University of Almeria, Almeria, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Perez-Marmol', 'Affiliation': 'Instituto de Investigación Biosanitaria ibs. Granada, Granada, Spain.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Leonard', 'Affiliation': 'École de Réadaptation, Faculté de Médecine et des Sciences de la Santé, Université de Sherbrooke, Sherbrooke, Québec, Canada.'}, {'ForeName': 'Nathaly', 'Initials': 'N', 'LastName': 'Gaudreault', 'Affiliation': 'École de Réadaptation, Faculté de Médecine et des Sciences de la Santé, Université de Sherbrooke, Sherbrooke, Québec, Canada.'}, {'ForeName': 'María Encarnación', 'Initials': 'ME', 'LastName': 'Aguilar-Ferrándiz', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Guillermo Adolfo', 'Initials': 'GA', 'LastName': 'Matarán-Peñarrocha', 'Affiliation': 'Instituto de Investigación Biosanitaria ibs. Granada, Granada, Spain.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1136/acupmed-2017-011504']
2776,31348051,"Comparison of Macintosh Laryngoscopy in Bed-up-Head-Elevated Position With GlideScope Laryngoscopy: A Randomized, Controlled, Noninferiority Trial.","BACKGROUND


Approximately half of all difficult tracheal intubations (DTIs) are unanticipated; hence, proper positioning during intubation is critical to increase the likelihood of success. The bed-up-head-elevated (BUHE) intubation position has been shown to improve laryngeal view, reduce airway complications, and prolong safe apneic time during intubation. In this study, we sought to determine whether the BUHE intubation position is noninferior to Glidescope (GLSC)-assisted intubation with regard to laryngeal exposure.
METHODS


A total of 138 American Society of Anesthesiologists (ASA) I to III patients were randomly assigned into 2 groups and underwent baseline laryngoscopy in the sniffing position. Group BUHE patients (n = 69) were then intubated in the BUHE position, while group GLSC patients (n = 69) were intubated using GLSC laryngoscopy. Laryngeal exposure was measured using Percentage of Glottic Opening (POGO) score and Cormack-Lehane (CL) grading, and noninferiority will be declared if the difference in mean POGO scores between both groups do not exceed -15% at the lower limit of a 98% confidence interval (CI). Secondary outcomes measured included time required for intubation (TRI), number of intubation attempts, use of airway adjuncts, effort during laryngoscopy, and complications during intubation.
RESULTS


Mean POGO score in group BUHE was 80.14% ± 22.03%, while in group GLSC it was 86.45% ± 18.83%, with a mean difference of -6.3% (98% CI, -13.2% to 0.6%). In both groups, there was a significant improvement in mean POGO scores when compared to baseline laryngoscopy in the sniffing position (group BUHE, 25.8% ± 4.7%; group GLSC, 30.7% ± 6.8%) (P < .0001). The mean TRI was 36.23 ± 14.41 seconds in group BUHE, while group GLSC had a mean TRI of 44.33 ± 11.53 seconds (P < .0001). In patients with baseline CL 3 grading, there was no significant difference between mean POGO scores in both groups (group BUHE, 49.2% ± 19.6% versus group GLSC, 70.5% ± 29.7%; P = .054).
CONCLUSIONS


In the general population, BUHE intubation position provides a noninferior laryngeal view to GLSC intubation. The laryngeal views obtained in both approaches were superior to the laryngeal view obtained in the sniffing position. In view of the many advantages of the BUHE position for intubation, the lack of proven adverse effects, the simplicity, and the cost-effectiveness, we propose that clinicians should consider the BUHE position as the standard intubation position for the general population.",2020,"In both groups, there was a significant improvement in mean POGO scores when compared to baseline laryngoscopy in the sniffing position (group BUHE, 25.8% ± 4.7%; group GLSC, 30.7% ± 6.8%) (P < .0001).",['138 American Society of Anesthesiologists (ASA'],"['GlideScope Laryngoscopy', 'Glidescope (GLSC)-assisted intubation', 'baseline laryngoscopy in the sniffing position', 'Macintosh Laryngoscopy in Bed-up-Head-Elevated Position', 'GLSC laryngoscopy']","['mean POGO scores', 'Mean POGO score', 'time required for intubation (TRI), number of intubation attempts, use of airway adjuncts, effort during laryngoscopy, and complications during intubation', 'mean TRI', 'Percentage of Glottic Opening (POGO) score and Cormack-Lehane (CL) grading', 'safe apneic time', 'Laryngeal exposure']","[{'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}]","[{'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0018670', 'cui_str': 'Head'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",138.0,0.151325,"In both groups, there was a significant improvement in mean POGO scores when compared to baseline laryngoscopy in the sniffing position (group BUHE, 25.8% ± 4.7%; group GLSC, 30.7% ± 6.8%) (P < .0001).","[{'ForeName': 'Samuel E H', 'Initials': 'SEH', 'LastName': 'Tsan', 'Affiliation': 'From the Department of Anaesthesiology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Siu M', 'Initials': 'SM', 'LastName': 'Lim', 'Affiliation': 'From the Department of Anaesthesiology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Mohd F Z', 'Initials': 'MFZ', 'LastName': 'Abidin', 'Affiliation': 'From the Department of Anaesthesiology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Shahmini', 'Initials': 'S', 'LastName': 'Ganesh', 'Affiliation': 'From the Department of Anaesthesiology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Chew Y', 'Initials': 'CY', 'LastName': 'Wang', 'Affiliation': 'From the Department of Anaesthesiology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004349']
2777,31935158,The Effect of Educational Interventions on Willingness to Work with Older Adults: A Comparison of Students of Social Work and Health Professions.,"The study examined the effect of an educational intervention on the willingness of Israeli social work students to work with older adults, comparing them to students of nursing, speech therapy, and physiotherapy. A sample of 187 first-year students were divided into two groups: a research group (n=83) exposed to an educational intervention on ageing, and a control group (n=104) that received no intervention of any kind. Following the intervention, ageism among social work students in the research group decreased and positive behavior toward older adults increased. No significant differences were found among students of the health professions following the intervention. In addition, ageism mediated between knowledge of ageing and willingness to work with older adults.Furthermore, the higher the students assessed the contribution of the intervention, the lower their level of ageism, the more positive their behavior toward older adults, and the more willing they were to consider a career in geriatrics. The results suggest that introducing into the curriculum a variety of learning methods aimed at increasing knowledge of ageing and familiarity with the world of older adults is likely to encourage more students of social work and other therapeutic professions to work with the older population.",2020,No significant differences were found among students of the health professions following the intervention.,"['Students of Social Work and Health Professions', 'Israeli social work students to work with older adults', 'A sample of 187 first-year students', 'Older Adults']","['Educational Interventions', 'educational intervention', 'research group (n=83) exposed to an educational intervention on ageing, and a control group (n=104) that received no intervention of any kind']",['positive behavior'],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0035168'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0140292,No significant differences were found among students of the health professions following the intervention.,"[{'ForeName': 'Ahuva', 'Initials': 'A', 'LastName': 'Even-Zohar', 'Affiliation': 'School of Social Work, Faculty of Social Sciences, Ariel University, Ariel, Israel.'}, {'ForeName': 'Shoshi', 'Initials': 'S', 'LastName': 'Werner', 'Affiliation': 'Nursing Sciences, Faculty of Health sciences, Ariel University, Ariel, Israel.'}]",Journal of gerontological social work,['10.1080/01634372.2020.1712511']
2778,31964369,In vitro evaluation of a ceramic bracket with a laser-structured base.,"BACKGROUND


The purpose of this study was the assessment of shear bond strength (SBS), adhesive remnant characteristics, integrity of the enamel, integrity of Discovery Pearl as well as the integrity of Fascination 2 ceramic brackets following SBS testing.
METHODS


Sixty maxillary first premolars were randomly assigned into two groups. These groups were bonded with their respective brackets. The samples underwent thermocycling (1000 cycles), SBS testing and assessment of the residual adhesive. The statistical analyses used were the independent samples t-test, the Weibull analysis and the chi-square test.
RESULTS


The independent samples t-test for the comparison of the mean SBS resulted in significant differences between Fascination 2 (10.50 ± 2.61 MPa) and Pearl (13.01 ± 2.50 MPa) brackets (p = 0.0003). The results of the chi-square test for ARI demonstrated a significant difference (p = 0.000) between the groups. A higher frequency of ARI scores of 2 and 3 for Pearl brackets existed. Enamel damage and bracket fracturing was not observed.
CONCLUSIONS


The mean bond strength value, the adhesive remnant characteristics, the integrity of the enamel and the ceramic brackets as well as the Weibull analyses outcomes were highly encouraging during this in vitro screening. The way is paved for an in vivo investigation with the Pearl ceramic bracket.",2020,The results of the chi-square test for ARI demonstrated a significant difference (p = 0.000) between the groups.,['Sixty maxillary first premolars'],[],"['mean bond strength value', 'ARI scores', 'shear bond strength (SBS', 'Enamel damage and bracket fracturing']","[{'cui': 'C1704302', 'cui_str': 'Premolar'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}]",,0.0335165,The results of the chi-square test for ARI demonstrated a significant difference (p = 0.000) between the groups.,"[{'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'Elekdag-Türk', 'Affiliation': 'Faculty of Dentistry, Department of Orthodontics, University of Ondokuz Mayis, 55139 Kurupelit, Samsun, Turkey. elekdagturk@yahoo.com.'}]",BMC oral health,['10.1186/s12903-020-1009-9']
2779,31714592,Final report of a prospective randomized study on thoracic radiotherapy target volume for limited-stage small cell lung cancer with radiation dosimetric analyses.,"BACKGROUND


The thoracic radiotherapy (TRT) target volume for limited-stage small-cell lung cancer (SCLC) has been controversial for decades. In this report, the final results of a prospective randomized trial on the TRT target volume before and after induction chemotherapy are presented.
METHODS


After 2 cycles of etoposide and cisplatin, patients arm were randomized to receive TRT to the postchemotherapy or prechemotherapy tumor volume in a study arm and a control arm. Involved-field radiotherapy was received in both arms. TRT consisted of 1.5 grays (Gy) twice daily in 30 fractions to up to a total dose of 45 Gy. Lymph node regions were contoured, and intentional and incidental radiation doses were recorded.
RESULTS


The study was halted early because of slow accrual. Between 2002 and 2017, 159 and 150 patients were randomized to the study arm or the control arm, respectively; and 21.4% and 19.1% of patients, respectively, were staged using positron emission tomography/computed tomography (P = .31). With a median follow-up of 54.1 months (range, 19.9-165.0 months) in survivors, the 3-year local/regional progression-free probability was 58.2% and 65.5% in the study and control arms, respectively (P = .44), and the absolute difference was -7.3% (95% CI, -18.2%, 3.7%). In the study and control arms, the median overall survival was 21.9 months and 26.6 months, respectively, and the 5-year overall survival rate was 22.8% and 28.1%, respectively (P = .26). Grade 3 esophagitis was observed in 5.9% of patients in the study arm versus 15.5% of those in the control arm (P = .01). The isolated out-of-field failure rate was 2.6% in the study arm versus 4.1% in the control arm (P = .46), and all such failures were located in the supraclavicular fossa or contralateral hilum. The regions 7, 3P, 4L, 6, 4R, 5, and 2L received incidental radiation doses >30 Gy.
CONCLUSIONS


TRT could be limited to the postchemotherapy tumor volume, and involved-field radiotherapy could be routinely applied for limited-stage SCLC.",2020,"The isolated out-of-field failure rate was 2.6% in the study arm versus 4.1% in the control arm (P = .46), and all such failures were located in the supraclavicular fossa or contralateral hilum.","['limited-stage small-cell lung cancer', 'Between 2002 and 2017, 159 and 150 patients']","['postchemotherapy or prechemotherapy', 'thoracic radiotherapy (TRT', 'TRT', 'positron emission tomography/computed tomography', 'etoposide and cisplatin', 'thoracic radiotherapy']","['median overall survival', '3-year local/regional progression-free probability', '5-year overall survival rate', 'Grade 3 esophagitis']","[{'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}]",,0.103374,"The isolated out-of-field failure rate was 2.6% in the study arm versus 4.1% in the control arm (P = .46), and all such failures were located in the supraclavicular fossa or contralateral hilum.","[{'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': 'Department of Radiation Oncology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yu-Jin', 'Initials': 'YJ', 'LastName': 'Xu', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}, {'ForeName': 'Hui-Neng', 'Initials': 'HN', 'LastName': 'Zhu', 'Affiliation': 'Department of Pathology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Jin-Shi', 'Initials': 'JS', 'LastName': 'Liu', 'Affiliation': 'Department of Thoracic Surgery, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Clinical Trials Center, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Department of Medical Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}, {'ForeName': 'Hong-Lian', 'Initials': 'HL', 'LastName': 'Ma', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}, {'ForeName': 'Xiao-Ling', 'Initials': 'XL', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Zheng-Bo', 'Initials': 'ZB', 'LastName': 'Song', 'Affiliation': 'Department of Medical Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Hua-Rong', 'Initials': 'HR', 'LastName': 'Tang', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Peng', 'Affiliation': 'Department of Radiation Oncology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Fang', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Kong', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}, {'ForeName': 'Meng-Yuan', 'Initials': 'MY', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}, {'ForeName': 'Bai-Qiang', 'Initials': 'BQ', 'LastName': 'Dong', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Pathology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Department of Pathology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Xin-Min', 'Initials': 'XM', 'LastName': 'Yu', 'Affiliation': 'Department of Medical Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hong', 'Affiliation': 'Department of Medical Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of Medical Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Yi-Ping', 'Initials': 'YP', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Peng-Cheng', 'Initials': 'PC', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of Thoracic Surgery, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'You-Hua', 'Initials': 'YH', 'LastName': 'Jiang', 'Affiliation': 'Department of Thoracic Surgery, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Xin-Ming', 'Initials': 'XM', 'LastName': 'Zhou', 'Affiliation': 'Department of Thoracic Surgery, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Qi-Xun', 'Initials': 'QX', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Wen-Yong', 'Initials': 'WY', 'LastName': 'Sun', 'Affiliation': 'Department of Pathology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Wei-Min', 'Initials': 'WM', 'LastName': 'Mao', 'Affiliation': 'Department of Thoracic Surgery, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}]",Cancer,['10.1002/cncr.32586']
2780,31994819,Need for pacing in patients who qualify for an implantable cardioverter-defibrillator: Clinical implications for the subcutaneous ICD.,"BACKGROUND


Implantation of the subcutaneous implantable cardioverter-defibrillator (S-ICD) is spreading and has been shown to be safe and effective; however, it does not provide brady-pacing. Currently, data on the need for brady-pacing and cardiac resynchronization therapy (CRT) implantation in patients with ICD indication are limited.
METHODS


The Multicenter Automatic Defibrillator Implantation Trial (MADIT)-II enrolled post-MI patients with reduced ejection fraction (EF ≤ 35%), randomized to either an implantable cardioverter-defibrillator (ICD) or conventional medical therapy. Kaplan-Meier analyses and multivariate Cox models were performed to assess the incidence and predictors of pacemaker (PM), or CRT implantation in the conventional arm of MADIT-II, after excluding 32 patients (6.5%) with a previously implanted PM.
RESULTS


During the median follow-up of 20 months, 24 of 458 patients (5.2%) were implanted with a PM or a CRT (19 PM, 5 CRT). Symptomatic sinus bradycardia was the primary indication for PM implantation (n = 9, 37%), followed by AV block (n = 5, 21%), tachy-brady syndrome (n = 4, 17%), and carotid sinus hypersensitivity (n = 1, 4%). Baseline PR interval >200 ms (HR = 3.07, 95% CI: 1.24-7.57, p = .02), and CABG before enrollment (HR = 6.88, 95% CI: 1.58-29.84, p = .01) predicted subsequent PM/CRT implantation. Patients with PM/CRT implantation had a significantly higher risk for heart failure (HR = 2.67, 95% CI = 1.38-5.14, p = .003), but no increased mortality risk (HR = 1.06, 95% CI = 0.46-2.46, p = .89).
CONCLUSION


The short-term need for ventricular pacing or CRT implantation in patients with MADIT-II ICD indication was low, especially in those with a normal baseline PR interval, and such patients are appropriate candidates for the subcutaneous ICD.",2020,"Baseline PR interval >200 ms (HR = 3.07, 95% CI: 1.24-7.57, p = .02), and CABG before enrollment (HR = 6.88, 95% CI: 1.58-29.84, p = .01) predicted subsequent PM/CRT implantation.","['patients with ICD', 'MI patients with reduced ejection fraction (EF\xa0≤\xa035', 'patients who qualify for an implantable cardioverter-defibrillator']","['ventricular pacing or CRT implantation', 'subcutaneous implantable cardioverter-defibrillator (S-ICD', 'cardiac resynchronization therapy (CRT) implantation', 'implantable cardioverter-defibrillator (ICD) or conventional medical therapy']","['incidence and predictors of pacemaker (PM), or CRT implantation', 'carotid sinus hypersensitivity', 'mortality risk', 'Symptomatic sinus bradycardia', 'risk for heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}]","[{'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}, {'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0741983', 'cui_str': 'Carotid sinus hypersensitivity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0748712', 'cui_str': 'Symptomatic sinus bradycardia (disorder)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",,0.084377,"Baseline PR interval >200 ms (HR = 3.07, 95% CI: 1.24-7.57, p = .02), and CABG before enrollment (HR = 6.88, 95% CI: 1.58-29.84, p = .01) predicted subsequent PM/CRT implantation.","[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Kutyifa', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Spencer Z', 'Initials': 'SZ', 'LastName': 'Rosero', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'McNitt', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Bronislava', 'Initials': 'B', 'LastName': 'Polonsky', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Mary W', 'Initials': 'MW', 'LastName': 'Brown', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Zareba', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Goldenberg', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}]","Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc",['10.1111/anec.12744']
2781,31998949,"Surface Perturbation Training to Prevent Falls in Older Adults: A Highly Pragmatic, Randomized Controlled Trial.","BACKGROUND


Falls are the leading cause of injuries among older adults, and trips and slips are major contributors to falls.
OBJECTIVE


The authors sought to compare the effectiveness of adding a component of surface perturbation training to usual gait/balance training for reducing falls and fall-related injury in high-risk older adults referred to physical therapy.
DESIGN


This was a multi-center, pragmatic, randomized, comparative effectiveness trial.
SETTING


Treatment took place within 8 outpatient physical therapy clinics.
PATIENTS


This study included 506 patients 65+ years of age at high fall risk referred for gait/balance training.
INTERVENTION


This trial evaluated surface perturbation treadmill training integrated into usual multimodal exercise-based balance training at the therapist's discretion versus usual multimodal exercise-based balance training alone.
MEASUREMENTS


Falls and injurious falls were assessed with a prospective daily fall diary, which was reviewed via telephone interview every 3 months for 1 year.A total of 211/253 (83%) patients randomized to perturbation training and 210/253 (83%) randomized to usual treatment provided data at 3-month follow-up. At 3 months, the perturbation training group had a significantly reduced chance of fall-related injury (5.7% versus 13.3%; relative risk 0.43) but no significant reduction in the risk of any fall (28% versus 37%, relative risk 0.78) compared with usual treatment. Time to first injurious fall showed reduced hazard in the first 3 months but no significant reduction when viewed over the entire first year.
LIMITATIONS


The limitations of this trial included lack of blinding and variable application of interventions across patients based on pragmatic study design.
CONCLUSION


The addition of some surface perturbation training to usual physical therapy significantly reduced injurious falls up to 3 months posttreatment. Further study is warranted to determine the optimal frequency, dose, progression, and duration of surface perturbation aimed at training postural responses for this population.",2020,"At 3 months, the perturbation-training group had significantly reduced chance of fall-related injury (5.7% vs. 13.3%; relative risk 0.43, p < 0.01) but no significant reduction in the risk of any fall (28% vs. 37% ST; relative risk 0.78 p<0.07) compared to usual treatment.","['high-risk older adults', 'Older Adults', 'Treatment took place within 8 outpatient physical therapy clinics', '506 patients aged 65+ at high fall risk referred for gait/balance training']","['surface-perturbation training to usual gait/balance training', 'Surface Perturbation Training', ""usual multimodal exercise-based balance training at the therapist's discretion versus usual multimodal exercise-based balance training alone""]","['injurious falls', 'Falls and injurious falls', 'chance of fall-related injury']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]",506.0,0.0271618,"At 3 months, the perturbation-training group had significantly reduced chance of fall-related injury (5.7% vs. 13.3%; relative risk 0.43, p < 0.01) but no significant reduction in the risk of any fall (28% vs. 37% ST; relative risk 0.78 p<0.07) compared to usual treatment.","[{'ForeName': 'Jon D', 'Initials': 'JD', 'LastName': 'Lurie', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, One Medical Center Dr, Lebanon, NH 03781 (USA), and Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'Alexandra B', 'Initials': 'AB', 'LastName': 'Zagaria', 'Affiliation': 'Geisel School of Medicine at Dartmouth.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ellis', 'Affiliation': 'Elliot Hospital Senior Health Center Rehabilitation, Manchester, New Hampshire.'}, {'ForeName': 'Dawna', 'Initials': 'D', 'LastName': 'Pidgeon', 'Affiliation': 'Dartmouth-Hitchcock Medical Center.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Gill-Body', 'Affiliation': 'Newton-Wellesley Hospital, Newton, Massachusetts. Dr Gill-Body is a board-certified clinical specialist in neurologic physical therapy.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Burke', 'Affiliation': 'South Shore Neurologic Associates, Patchogue, New York. Dr Burke is a board-certified clinical specialist in neurologic physical therapy.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Armbrust', 'Affiliation': 'White River Junction Veterans Administration Hospital, White River Junction, Vermont.'}, {'ForeName': 'Sharil', 'Initials': 'S', 'LastName': 'Cass', 'Affiliation': 'Farnum Rehabilitation Center, Keene, New Hampshire.'}, {'ForeName': 'Kevin F', 'Initials': 'KF', 'LastName': 'Spratt', 'Affiliation': 'Geisel School of Medicine at Dartmouth.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'McDonough', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",Physical therapy,['10.1093/ptj/pzaa023']
2782,31339815,Can Participants' Characteristics Predict Benefit from a Multimodal Burnout Prevention Program? Secondary Analysis of a Randomized Controlled Trial Conducted in Germany.,"Chronic psychological distress appears to be increasing markedly among the working population. A recent randomized controlled trial (RCT) supported the effectiveness of a three-week outpatient burnout prevention program-comprised of stress management interventions, relaxation, physical exercise, and moor baths followed by massage-in reducing perceived stress and emotional exhaustion. However, the effectiveness of treatments in the real world that were shown to be efficacious in RCTs is related to the appropriate selection of individuals who are most likely to yield sustainable gains. Therefore, factors predicting the intensity of response and nonresponse of individuals to treatment are of interest. This secondary data analysis aims to explore predictors of response to the outpatient burnout prevention program in a sample of eighty employed persons at high risk of burnout. Hierarchical linear regression was performed to identify predictors of successful response-defined by lower perceived stress at last follow up. Nutritional behavior, symptoms of eating disorder syndrome, and well-being were significant predictors of perceived stress at last follow up, when adjusted for age, sex, education level, baseline stress values, and timing of intervention. Persons with low levels of well-being, poor nutritional behavior, and higher symptoms of eating disorders should be given special care and attention to ensure that they respond well to the outpatient burnout prevention program.",2020,"Nutritional behavior, symptoms of eating disorder syndrome, and well-being were significant predictors of perceived stress at last follow up, when adjusted for age, sex, education level, baseline stress values, and timing of intervention.","['Persons with low levels of well-being, poor nutritional behavior, and higher symptoms of eating disorders', 'eighty employed persons at high risk of burnout']","['stress management interventions, relaxation, physical exercise, and moor baths followed by massage', 'outpatient burnout prevention program']","['Nutritional behavior, symptoms of eating disorder syndrome', 'Chronic psychological distress']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}]","[{'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0150141'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",80.0,0.0303506,"Nutritional behavior, symptoms of eating disorder syndrome, and well-being were significant predictors of perceived stress at last follow up, when adjusted for age, sex, education level, baseline stress values, and timing of intervention.","[{'ForeName': 'Anushiya', 'Initials': 'A', 'LastName': 'Vanajan', 'Affiliation': 'Research group for Work and Retirement, Netherlands Interdisciplinary Demographic Institute, The Hague, The Netherlands.'}, {'ForeName': 'Marita', 'Initials': 'M', 'LastName': 'Stier-Jarmer', 'Affiliation': 'Chair for Public Health and Health Services Research, Institute for Medical Information Processing, Biometry, and Epidemiology, Ludwig Maximilians University, Munich, Germany.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Ivandic', 'Affiliation': 'Institute and Outpatient Clinic for Occupational, Social, and Environmental Medicine, University Hospital Munich, Ludwig Maximilians University, Munich, Germany.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Schuh', 'Affiliation': 'Chair for Public Health and Health Services Research, Institute for Medical Information Processing, Biometry, and Epidemiology, Ludwig Maximilians University, Munich, Germany.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Sabariego', 'Affiliation': 'Chair for Public Health and Health Services Research, Institute for Medical Information Processing, Biometry, and Epidemiology, Ludwig Maximilians University, Munich, Germany.'}]","Behavioral medicine (Washington, D.C.)",['10.1080/08964289.2019.1594671']
2783,31268376,Sarilumab monotherapy or in combination with non-methotrexate disease-modifying antirheumatic drugs in active rheumatoid arthritis: A Japan phase 3 trial (HARUKA).,"Objectives:  To determine long-term safety and efficacy of sarilumab as monotherapy or with non-methotrexate (MTX) conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) in Japanese patients with active rheumatoid arthritis (RA). Methods:  In this double-blind, randomized study (NCT02373202), patients received subcutaneous sarilumab 150 mg q2w (S150) or 200 mg q2w (S200) as monotherapy or with non-MTX csDMARDs for 52 weeks. The primary endpoint was safety. Results:  Sixty-one patients received monotherapy (S150,  n  = 30; S200,  n  = 31) and 30 received combination therapy (S150 + csDMARDs,  n  = 15; S200 + csDMARDs,  n  = 15). Rates of treatment-emergent adverse events (TEAEs) were 83.3%/90.3%/93.3%/86.7% for S150/S200/S150 + csDMARDs/S200 + csDMARDs, respectively. Nasopharyngitis and neutropenia were the most frequently reported TEAEs. One serious infection was reported in each monotherapy group and in the S200 + csDMARDs group. There were no cases of grade 4 neutropenia; no patients with grade 3 neutropenia experienced associated serious infection. Improvements in ACR20/50/70 response rates were generally similar between the two monotherapy groups and between the two combination groups; improvements in physical function (Health Assessment Questionnaire-Disability Index, HAQ-DI) and DAS28-CRP were observed at weeks 24 and 52 (all groups). Conclusion:  The safety profile of sarilumab was consistent with known class effects of interleukin-6 signaling blockade therapeutics. Sarilumab as mono- or combination therapy improved clinical signs/symptoms and physical function in Japanese RA patients.",2020,Improvements in ACR20/50/70 response rates were generally similar between the two monotherapy groups and between the two combination groups; improvements in physical function (HAQ-DI) and DAS28-CRP were observed at Weeks 24 and 52 (all groups).  ,"['Japanese RA patients', 'active rheumatoid arthritis', 'Japanese patients with active rheumatoid arthritis (RA']","['monotherapy (S150,  n \u2009=\u200930; S200,  n \u2009=\u200931) and 30 received combination therapy (S150\u2009+\u2009csDMARDs,  n \u2009=\u200915; S200\u2009+\u2009csDMARDs,  n \u2009=\u200915', 'Sarilumab monotherapy or in combination with non-methotrexate disease-modifying antirheumatic drugs', 'sarilumab as monotherapy or with non-methotrexate conventional synthetic disease-modifying antirheumatic drugs (csDMARDs', 'subcutaneous sarilumab 150\u2009mg q2w (S150) or 200\u2009mg q2w (S200) as monotherapy or with non-methotrexate']","['safety', 'clinical signs/symptoms and physical function', 'Grade 4 neutropenia', 'Nasopharyngitis and neutropenia', 'serious infection', 'physical function (HAQ-DI) and DAS28-CRP', 'ACR20/50/70 response rates']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}]","[{'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0102923', 'cui_str': 'HAQ'}]",,0.106883,Improvements in ACR20/50/70 response rates were generally similar between the two monotherapy groups and between the two combination groups; improvements in physical function (HAQ-DI) and DAS28-CRP were observed at Weeks 24 and 52 (all groups).  ,"[{'ForeName': 'Hideto', 'Initials': 'H', 'LastName': 'Kameda', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Toho University (Ohashi Medical Center), Tokyo, Japan.'}, {'ForeName': 'Kazuteru', 'Initials': 'K', 'LastName': 'Wada', 'Affiliation': 'Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Hagino', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'van Hoogstraten', 'Affiliation': 'Sanofi-Genzyme, Cambridge, MA, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.'}]",Modern rheumatology,['10.1080/14397595.2019.1639939']
2784,31903986,Perioperative Ulinastatin helps preserve endothelial glycocalyx layer in periampullary carcinoma patients undergoing Traditional Whipple Procedure.,"BACKGROUND


Damage-associated molecular patterns (DAMPs) generated by major surgery can induce global inflammation response and may degrade the vascular endothelial glycocalyx layer (EGL); in turn, the resulting EGL fragments can act as DAMPs, in a destructive positive feedback loop, to promote exacerbation of inflammation. Ulinastatin (UTI) may attenuate EGL shedding by inhibiting serine proteases and hyaluronidase.
OBJECTIVE


This trail evaluates whether EGL shedding elicited by Traditional Whipple Procedure (TWP) could be decreased by using UTI.
METHODS


We divided 60 patients undergoing TWP into a control group and a UTI group (n = 30 for both). Blood samples were collected before (T0), near the end (T1), and 1 hour after (T2) surgery. Levels of syndecan-1, ICAM-1, VCAM-1, IL-6, C-reactive protein, thrombomodulin, Hbg and serum albumin were measured and plasma albumin leakage was estimated.
RESULTS


IL-6 levels significantly elevated at T1 and T2 in the control group compared with T0, but not the UTI group. Syndecan-1 levels significantly elevated at T1 and T2 in the control group but only T2 in the UTI group compared with T0.
CONCLUSIONS


We found global inflammation reaction and EGL degradation during TWP. Perioperative UTI treatment can attenuate this EGL shedding and might alleviate plasma albumin leakage.",2020,"Levels of syndecan-1, ICAM-1, VCAM-1, IL-6, C-reactive protein, thrombomodulin, Hbg and serum albumin were measured and plasma albumin leakage was estimated.
","['60 patients undergoing TWP into a control group and a UTI group (n\u200a=\u200a30 for both', 'periampullary carcinoma patients undergoing traditional Whipple procedure']","['Ulinastatin (UTI', 'Perioperative Ulinastatin', 'Traditional Whipple Procedure (TWP']","['Syndecan-1 levels', 'Levels of syndecan-1, ICAM-1, VCAM-1, IL-6, C-reactive protein, thrombomodulin, Hbg and serum albumin', 'Blood samples', 'global inflammation reaction and EGL degradation', 'IL-6 levels', 'plasma albumin leakage', 'endothelial glycocalyx layer']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0861830', 'cui_str': 'Periampullary carcinoma NOS'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}]","[{'cui': 'C0077906', 'cui_str': 'UTI68'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}]","[{'cui': 'C1609943', 'cui_str': 'CD138 Antigens'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}, {'cui': 'C0078056', 'cui_str': 'CD106 Antigens'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C1260311', 'cui_str': 'Plasma Albumin'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0061622', 'cui_str': 'Cell Coat'}]",60.0,0.0857293,"Levels of syndecan-1, ICAM-1, VCAM-1, IL-6, C-reactive protein, thrombomodulin, Hbg and serum albumin were measured and plasma albumin leakage was estimated.
","[{'ForeName': 'Jia-Wan', 'Initials': 'JW', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Beijing Chaoyang Hospital Affiliated to Capital Medical University, Beijing, China.'}, {'ForeName': 'An-Shi', 'Initials': 'AS', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Beijing Chaoyang Hospital Affiliated to Capital Medical University, Beijing, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Yue', 'Affiliation': 'Department of Anesthesiology, Beijing Chaoyang Hospital Affiliated to Capital Medical University, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Beijing Chaoyang Hospital Affiliated to Capital Medical University, Beijing, China.'}]",Clinical hemorheology and microcirculation,['10.3233/CH-190688']
2785,31774028,Randomized clinical trial comparing buprenorphine/naloxone and methadone for the treatment of patients with failed back surgery syndrome and opioid addiction.,"Opioid analgesic consumption has led to an unprecedented epidemic of overdose death and opioid addiction in the US history. The treatment of chronic pain in patients with opioid addiction who receive prescriptions for opioid medications presents a clinical dilemma. Continuing opioid medication could result in hyperalgesia rendering opioids ineffective and results in iatrogenic therapeutic damage as evidenced by the worsening of addiction. Discontinuing opioid medications could result in severe pain and cravings that often leads the patient to the illicit market. This study compared methadone and buprenorphine/naloxone in patients with failed back surgery syndrome and opioid addiction. Nineteen participants were randomly assigned to methadone or buprenorphine/naloxone and were followed for 6 months. In an intent-to-treat analysis analgesia, craving, functioning, drug use, depression, and treatment retention were assessed monthly. It was planned to enroll 66 patients with failed back surgery syndrome and opioid addiction; however, enrollment was closed early due to suspected abuse of medications. Patients in both treatment conditions exhibited significantly improved 24-hour pain severity with up to 20% reduction of pain severity at the last follow-up ( p  < .05). However, patients receiving methadone reported significantly reduced current pain severity, whereas patients receiving buprenorphine/naloxone did not. Patients reported significantly improved functioning, fewer cravings, less opioid use, and depression ( p  < .05) across the treatment conditions. When given a choice between methadone and buprenorphine/naloxone, buprenorphine/naloxone is recommended due to its superior safety profile. Treatment with either needs to be monitored closely.",2020,"Patients reported significantly improved functioning, fewer cravings, less opioid use, and depression ( p  < .05) across the treatment conditions.","['Nineteen participants', 'patients with failed back surgery syndrome and opioid addiction', '66 patients with failed back surgery syndrome and opioid addiction', 'patients with opioid addiction who receive prescriptions for']","['methadone', 'methadone or buprenorphine/naloxone', 'buprenorphine/naloxone and methadone', 'buprenorphine/naloxone', 'buprenorphine/naloxone, buprenorphine/naloxone', 'opioid medications', 'methadone and buprenorphine/naloxone']","['24-hour pain severity', 'severe pain and cravings', 'functioning, fewer cravings, less opioid use, and depression', 'pain severity', 'current pain severity']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963763', 'cui_str': 'Failed Back Surgery Syndrome'}, {'cui': 'C0524662', 'cui_str': 'Opiate Dependence'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine / Naloxone'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]","[{'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}]",66.0,0.0325178,"Patients reported significantly improved functioning, fewer cravings, less opioid use, and depression ( p  < .05) across the treatment conditions.","[{'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Neumann', 'Affiliation': 'Primary Care Research Institute, Department of Family Medicine, The State University of New York at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Blondell', 'Affiliation': 'Primary Care Research Institute, Department of Family Medicine, The State University of New York at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Hoopsick', 'Affiliation': 'Primary Care Research Institute, Department of Family Medicine, The State University of New York at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Homish', 'Affiliation': 'Department of Community Health and Health Behavior, The State University of New York at Buffalo, Buffalo, NY, USA.'}]",Journal of addictive diseases,['10.1080/10550887.2019.1690929']
2786,31843386,Effects of hydrochlorothiazide on drainage volume and seroma formation in deep inferior epigastric perforator flap breast reconstruction: Randomized controlled trial.,"BACKGROUND


Seroma is a recognized complication encountered at the reconstructed breast and donor site after abdominal-based breast reconstruction. Seroma is caused by lymphatic channel disruption and the formation of a large space between the deep fascia during flap elevation. Surgical techniques to preserve the lymphatics and secure the closure of the donor site can reduce seroma formation. This study investigated the safety and effectiveness of the diuretic hydrochlorothiazide at reducing interstitial fluid accumulation and seroma formation during deep inferior epigastric perforator (DIEP) flap breast reconstruction.
METHODS


Sixty patients with breast cancer who underwent skin- or nipple-sparing mastectomy and DIEP flap reconstruction were enrolled between August 2016 and June 2017. The patients were randomly assigned to receive either 25 mg per day of hydrochlorothiazide from the second to the twentieth day after surgery (treatment) or no diuretic (control). The clinicopathological characteristics, drainage time, and drainage volume were statistically compared between the two groups.
RESULTS


The average total drainage volume at the donor site was 291 mL in the treatment group and 434 mL in the control group (p = 0.003). The differences in body mass index and flap weight between the two groups were not statistically significant (p = 0.879 and p = 0.963, respectively). No hypotension or electrolyte imbalance was noted during the follow-up.
CONCLUSIONS


Intake of 25 mg per day of hydrochlorothiazide tablets effectively reduced the total abdominal drainage volume and removal time of indwelling drains. However, the adverse effects should be further investigated in a large population and multiracial cohort before using hydrochlorothiazide for seroma prevention.",2020,"The differences in body mass index and flap weight between the two groups were not statistically significant (p = 0.879 and p = 0.963, respectively).","['deep inferior epigastric perforator flap breast reconstruction', 'Sixty patients with breast cancer who underwent skin- or nipple-sparing mastectomy and DIEP flap reconstruction were enrolled between August 2016 and June 2017']","['diuretic hydrochlorothiazide', 'hydrochlorothiazide from the second to the twentieth day after surgery (treatment) or no diuretic (control', 'hydrochlorothiazide']","['hypotension or electrolyte imbalance', 'body mass index and flap weight', 'total abdominal drainage volume and removal time of indwelling drains', 'drainage volume and seroma formation', 'average total drainage volume', 'clinicopathological characteristics, drainage time, and drainage volume']","[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C3494192', 'cui_str': 'Perforator Flap'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0457424', 'cui_str': 'Nippled (qualifier value)'}, {'cui': 'C0024886', 'cui_str': 'Total Mastectomy'}, {'cui': 'C0082274', 'cui_str': 'diclofenac epolamine'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}]","[{'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0342579', 'cui_str': 'Electrolyte imbalance (disorder)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439848', 'cui_str': 'Indwelling (qualifier value)'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}]",60.0,0.0240172,"The differences in body mass index and flap weight between the two groups were not statistically significant (p = 0.879 and p = 0.963, respectively).","[{'ForeName': 'Y C', 'Initials': 'YC', 'LastName': 'Suh', 'Affiliation': ""Department of Plastic Surgery, Bucheon St. Mary's Hospital, The Catholic University of Korea, College of Medicine, 327, Sosa-ro, Bucheon-si, Gyeonggi-do, Republic of Korea.""}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Oh', 'Affiliation': 'Department of Plastic Surgery, Asan Medical Center, University of Ulsan, College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Y H', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Plastic Surgery, Asan Medical Center, University of Ulsan, College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea.'}, {'ForeName': 'E K', 'Initials': 'EK', 'LastName': 'Kim', 'Affiliation': 'Department of Plastic Surgery, Asan Medical Center, University of Ulsan, College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea.'}, {'ForeName': 'H H', 'Initials': 'HH', 'LastName': 'Han', 'Affiliation': 'Department of Plastic Surgery, Asan Medical Center, University of Ulsan, College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Eom', 'Affiliation': 'Department of Plastic Surgery, Asan Medical Center, University of Ulsan, College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea. Electronic address: jinsupp@amc.seoul.kr.'}]","Journal of plastic, reconstructive & aesthetic surgery : JPRAS",['10.1016/j.bjps.2019.11.009']
2787,29995679,Effect of Hospital Volume With Respect to Performing Gastric Cancer Resection on Recurrence and Survival: Results From the CRITICS Trial.,"OBJECTIVE


We examined the association between surgical hospital volume and both overall survival (OS) and disease-free survival (DFS) using data obtained from the international CRITICS (ChemoRadiotherapy after Induction chemotherapy In Cancer of the Stomach) trial.
SUMMARY BACKGROUND DATA


In the CRITICS trial, patients with resectable gastric cancer were randomized to receive preoperative chemotherapy followed by adequate gastrectomy and either chemotherapy or chemoradiotherapy.
METHODS


Patients in the CRITICS trial who underwent a gastrectomy with curative intent in a Dutch hospital were included in the analysis. The annual number of gastric cancer surgeries performed at the participating hospitals was obtained from the Netherlands Cancer Registry; the hospitals were then classified as low-volume (1-20 surgeries/year) or high-volume (≥21 surgeries/year) and matched with the CRITICS trial data. Univariate and multivariate analyses were then performed to evaluate the hazard ratio (HR) between hospital volume and both OS and DFS.
RESULTS


From 2007 through 2015, 788 patients were included in the CRITICS trial. Among these 788 patients, 494 were eligible for our study; the median follow-up was 5.0 years. Five-year OS was 59.2% and 46.1% in the high-volume and low-volume hospitals, respectively. Multivariate analysis revealed that undergoing surgery in a high-volume hospital was associated with higher OS [HR = 0.69, 95% confidence interval (CI) = 0.50-0.94, P = 0.020] and DFS (HR = 0.73, 95% CI: 0.54-0.99, P = 0.040).
CONCLUSIONS


In the CRITICS trial, hospitals with a high annual volume of gastric cancer surgery were associated with higher overall and DFS. These findings emphasize the value of centralizing gastric cancer surgeries in the Western world.",2019,"Multivariate analysis revealed that undergoing surgery in a high-volume hospital was associated with higher OS [HR = 0.69, 95% confidence interval (CI) = 0.50-0.94, P = 0.020] and DFS (HR = 0.73, 95% CI: 0.54-0.99, P = 0.040).
","['Patients in the CRITICS trial who underwent a gastrectomy with curative intent in a Dutch hospital were included in the analysis', 'patients with resectable gastric cancer', 'From 2007 through 2015, 788 patients were included in the CRITICS trial', '788 patients, 494 were eligible for our study; the median follow-up was 5.0 years']","['Hospital Volume', 'international CRITICS (ChemoRadiotherapy after Induction chemotherapy', 'Gastric Cancer Resection', 'preoperative chemotherapy followed by adequate gastrectomy and either chemotherapy or chemoradiotherapy']","['Recurrence and Survival', 'annual number of gastric cancer surgeries', 'surgical hospital volume and both overall survival (OS) and disease-free survival (DFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0335034', 'cui_str': 'Critic (occupation)'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",788.0,0.174057,"Multivariate analysis revealed that undergoing surgery in a high-volume hospital was associated with higher OS [HR = 0.69, 95% confidence interval (CI) = 0.50-0.94, P = 0.020] and DFS (HR = 0.73, 95% CI: 0.54-0.99, P = 0.040).
","[{'ForeName': 'Yvette H M', 'Initials': 'YHM', 'LastName': 'Claassen', 'Affiliation': 'Department of Surgical Oncology, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Romy M', 'Initials': 'RM', 'LastName': 'van Amelsfoort', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Henk H', 'Initials': 'HH', 'LastName': 'Hartgrink', 'Affiliation': 'Department of Surgical Oncology, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Johan L', 'Initials': 'JL', 'LastName': 'Dikken', 'Affiliation': 'Department of Surgical Oncology, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Wobbe O', 'Initials': 'WO', 'LastName': 'de Steur', 'Affiliation': 'Department of Surgical Oncology, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Johanna W', 'Initials': 'JW', 'LastName': 'van Sandick', 'Affiliation': 'Department of Surgical Oncology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, The Netherlands.'}, {'ForeName': 'Nicole C T', 'Initials': 'NCT', 'LastName': 'van Grieken', 'Affiliation': 'Department of Pathology, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Annemieke', 'Initials': 'A', 'LastName': 'Cats', 'Affiliation': 'Department of Gastrointestinal Oncology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Boot', 'Affiliation': 'Department of Gastrointestinal Oncology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Anouk K', 'Initials': 'AK', 'LastName': 'Trip', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Edwin P M', 'Initials': 'EPM', 'LastName': 'Jansen', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Elma Meershoek-Klein', 'Initials': 'EM', 'LastName': 'Kranenbarg', 'Affiliation': 'Department of Surgical Oncology, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Jeffrey P B M', 'Initials': 'JPBM', 'LastName': 'Braak', 'Affiliation': 'Department of Surgical Oncology, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Medical Statistics, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Mark I', 'Initials': 'MI', 'LastName': 'van Berge Henegouwen', 'Affiliation': 'Department of Surgery, Academic Medical Center and Cancer Center Amsterdam, The Netherlands.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Verheij', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Cornelis J H', 'Initials': 'CJH', 'LastName': 'van de Velde', 'Affiliation': 'Department of Surgical Oncology, Leiden University Medical Center, The Netherlands.'}]",Annals of surgery,['10.1097/SLA.0000000000002940']
2788,32003275,Improving Medication Adherence Among Drug-Using HIV-Infected Formerly Incarcerated Individuals: A Pilot Test of Two Interventions.,"Incarcerated individuals in the United States are reportedly four times more likely to be infected with HIV than members of the general population, and a substantial proportion have a history of drug use. Postincarceration, many struggle to maintain their antiretroviral therapy (ART) regimen. This pilot study tested the potential performance of two ART adherence interventions, Project ADHerence Education and Risk Evaluation (ADHERE) and Medication Adherence and Care Engagement (MACE) among drug-using HIV-infected formerly incarcerated individuals in New York City. Thirty participants were randomized and completed the ADHERE or MACE intervention. Participants were interviewed and had their blood drawn for viral load testing at baseline and 3 months postintervention. Our findings suggest that drug-using HIV-infected formerly incarcerated individuals can benefit from brief ART adherence interventions. They also suggest that marijuana use may not have a negative impact on ART adherence.",2020,Our findings suggest that drug-using HIV-infected formerly incarcerated individuals can benefit from brief ART adherence interventions.,"['drug-using HIV-infected formerly incarcerated individuals in New York City', 'Formerly Incarcerated Individuals', 'Thirty participants']","['MACE intervention', 'ART adherence interventions, Project ADHerence Education and Risk Evaluation (ADHERE) and Medication Adherence and Care Engagement (MACE']",[],"[{'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0392751', 'cui_str': 'Incarcerated (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}]",[],30.0,0.056717,Our findings suggest that drug-using HIV-infected formerly incarcerated individuals can benefit from brief ART adherence interventions.,"[{'ForeName': 'Tawandra L', 'Initials': 'TL', 'LastName': 'Rowell-Cunsolo', 'Affiliation': 'School of Nursing, Columbia University, New York, NY, USA.'}, {'ForeName': 'Hyun K', 'Initials': 'HK', 'LastName': 'Hong', 'Affiliation': 'Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Rahma', 'Initials': 'R', 'LastName': 'Mkuu', 'Affiliation': 'Department of Health and Kinesiology, Texas A&M University, College Station, TX, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Britton', 'Affiliation': 'Mailman School of Public Health, Columbia University, New York, NY, USA.'}]",Journal of correctional health care : the official journal of the National Commission on Correctional Health Care,['10.1177/1078345819897634']
2789,32195897,Rapid Advancement in Enteral Nutrition Does Not Affect Systemic Inflammation and Insulin Homeostasis Following Pediatric Cardiopulmonary Bypass Surgery.,"OBJECTIVES


To determine impact of enteral nutrition delivery on the relationship among inflammation, insulin resistance, and outcomes following pediatric cardiopulmonary bypass surgery.
DESIGN


Pilot, randomized study analyzed according to intention-to-treat analysis.
SETTING


Pediatric cardiac ICU.
PATIENTS


Infants (≤ 6 mo) undergoing cardiopulmonary bypass.
INTERVENTIONS


Patients randomly assigned to receive rapid escalation to enteral nutrition reaching goal feeds by 27 hours or standard feeding practice reaching goal feeds by 63 hours. Feeds were initiated on the first postoperative day.
MEASUREMENTS AND MAIN RESULTS


Fifty patients were randomized equally to study arms. Patients were a median (interquartile range) of 16 days old (7-110 d old), undergoing biventricular surgery (88%) with a median cardiopulmonary bypass time of 125 minutes (105-159 min). Serial blood samples were drawn before and after cardiopulmonary bypass, cardiac ICU admission, and every 12 hours (up to 96 hr) for glucose, insulin, and cytokines (interleukin-1α, interleukin-6, interleukin-8, interleukin-10, and tumor necrosis factor-α) levels. Glucose-insulin ratio was calculated to quantify insulin resistance. Patient characteristics, time to enteral nutrition initiation, enteral nutrition interruptions, and insulin administration were similar across intervention arms. FF reached goal feeds at similar intervals as standard feeding (39 hr [30-60 hr] vs 60 hr [21-78 hr]; p = 0.75). No difference in cytokine, insulin, or glucose-insulin ratio was noted between groups. Higher inflammation was associated with increased glucose-insulin ratio and higher risk of adverse events. In multivariable models of interleukin-8, FF was associated with increased glucose-insulin ratio (estimate of effect [95% CI], 0.152 [0.033-0.272]; p = 0.013). Although higher interleukin-8 was associated with an elevated risk of adverse event, this relationship was possibly mitigated by FF (odds ratio [95% CI], 0.086 [0.002-1.638]; p = 0.13).
CONCLUSIONS


A FF strategy was not associated with changes to early enteral nutrition delivery. Inflammation, insulin resistance, and morbidity were similar, but FF may modify the relationship between inflammation and adverse event. Multicenter nutrition studies are possible and necessary in this vulnerable population.",2020,"In multivariable models of interleukin-8, FF was associated with increased glucose-insulin ratio (estimate of effect [95% CI], 0.152 [0.033-0.272]; p = 0.013).","['Infants (≤ 6 mo) undergoing cardiopulmonary bypass', 'Fifty patients', 'Pediatric Cardiopulmonary Bypass Surgery', 'Patients were a median (interquartile range) of 16 days old (7-110 d old), undergoing biventricular surgery (88%) with a median cardiopulmonary bypass time of 125 minutes (105-159 min', 'pediatric cardiopulmonary bypass surgery']",['enteral nutrition delivery'],"['Systemic Inflammation and Insulin Homeostasis', 'cytokine, insulin, or glucose-insulin ratio', 'Glucose-insulin ratio', 'Patient characteristics, time to enteral nutrition initiation, enteral nutrition interruptions, and insulin administration', 'glucose, insulin, and cytokines (interleukin-1α, interleukin-6, interleukin-8, interleukin-10, and tumor necrosis factor-α) levels', 'Inflammation, insulin resistance, and morbidity', 'glucose-insulin ratio and higher risk of adverse events', 'glucose-insulin ratio']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0429123', 'cui_str': 'Cardiopulmonary bypass time (observable entity)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",50.0,0.273371,"In multivariable models of interleukin-8, FF was associated with increased glucose-insulin ratio (estimate of effect [95% CI], 0.152 [0.033-0.272]; p = 0.013).","[{'ForeName': 'Alejandro A', 'Initials': 'AA', 'LastName': 'Floh', 'Affiliation': 'Labatt Family Heart Centre, Department of Critical Care Medicine, University of Toronto, The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Joann', 'Initials': 'J', 'LastName': 'Herridge', 'Affiliation': 'Labatt Family Heart Centre, Department of Critical Care Medicine, University of Toronto, The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Chun-Po S', 'Initials': 'CS', 'LastName': 'Fan', 'Affiliation': 'Cardiovascular Data Management Centre, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Manlhiot', 'Affiliation': 'Cardiovascular Data Management Centre, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'McCrindle', 'Affiliation': 'Labatt Family Heart Centre, Division of Cardiology, University of Toronto, The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Van Arsdell', 'Affiliation': 'Labatt Family Heart Centre, Division of Cardiovascular Surgery, University of Toronto, The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Balmer-Minnes', 'Affiliation': ''}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Schwartz', 'Affiliation': 'Labatt Family Heart Centre, Department of Critical Care Medicine, University of Toronto, The Hospital for Sick Children, Toronto, ON, Canada.'}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002314']
2790,31882530,Prevalence and correlates of periodic limb movements in OSA and the effect of CPAP therapy.,"OBJECTIVE


We sought to assess the prevalence, correlates, and consequences of periodic limb movements of sleep (PLMS) in persons with obstructive sleep apnea (OSA) and the effect (worsening or improvement) of continuous positive airway pressure (CPAP) therapy on PLMS in a large prospective multicenter randomized controlled trial.
METHODS


We performed retrospective analyses of data from the Apnea Positive Pressure Long-term Efficacy Study, a prospective multicenter randomized controlled trial. A total of 1,105 persons with OSA enrolled in this study underwent a polysomnographic investigation at baseline, another one for CPAP titration, and another study 6 months after randomization to either active CPAP or sham CPAP.
RESULTS


Of all participants, 19.7% had PLM index (PLMI) ≥10/hour, 14.8% had PLMI ≥15/hour, 12.1% had PLMI ≥20/hour, 9.3% had PLMI ≥25/hour, and 7.5% had PLMI ≥30/hour. The odds of having a PLMI ≥10 were higher in older participants (odds ratio [OR] 1.03,  p  < 0.001), men (OR 1.63.  p  = 0.007), those using antidepressants (OR 1.48.  p  = 0.048), and those with higher caffeine use (OR 1.01,  p  = 0.04). After controlling for OSA and depression, PLMS were associated with increased sleep latency, reduced sleep efficiency, and reduced total sleep time. No significant relationships were noted between PLMS frequency and subjective sleepiness (Epworth Sleepiness Scale score) or objective sleepiness (Maintenance of Wakefulness Test). There was no differential effect of CPAP in comparison to sham CPAP on PLMS after 6 months of therapy.
CONCLUSIONS


PLMS are common in patients with OSA and are associated with a significant reduction in sleep quality over and above that conferred by OSA. Treatment with CPAP does not affect the severity of PLMS.",2020,No significant relationships were noted between PLMS frequency and subjective sleepiness (Epworth Sleepiness Scale score) or objective sleepiness (Maintenance of Wakefulness Test).,"['persons with obstructive sleep apnea (OSA', '1,105 persons with OSA enrolled', 'patients with OSA']","['continuous positive airway pressure (CPAP) therapy', 'active CPAP or sham CPAP', 'PLMI', 'CPAP therapy', 'periodic limb movements of sleep (PLMS', 'CPAP']","['PLMS frequency and subjective sleepiness (Epworth Sleepiness Scale score) or objective sleepiness (Maintenance of Wakefulness Test', 'sleep quality', 'PLM index', 'total sleep time', 'sleep latency, reduced sleep efficiency', 'severity of PLMS']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332182', 'cui_str': 'Periodic (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C4706348', 'cui_str': 'Epworth Sleepiness Scale score (observable entity)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0043012', 'cui_str': 'Wakefulnesses'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",1105.0,0.121071,No significant relationships were noted between PLMS frequency and subjective sleepiness (Epworth Sleepiness Scale score) or objective sleepiness (Maintenance of Wakefulness Test).,"[{'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Budhiraja', 'Affiliation': ""From the Divisions of Sleep and Circadian Disorders (R.B., S.J., L.J.E., O.O., S.F.Q.) and Pulmonary and Critical Care Medicine (R.B.), Department of Medicine, and Division of Sleep and Circadian Disorders (M.K.P.), Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; and Arizona Respiratory Center (S.F.Q.), University of Arizona, Tucson. rbudhiraja@bwh.harvard.edu.""}, {'ForeName': 'Sogol', 'Initials': 'S', 'LastName': 'Javaheri', 'Affiliation': ""From the Divisions of Sleep and Circadian Disorders (R.B., S.J., L.J.E., O.O., S.F.Q.) and Pulmonary and Critical Care Medicine (R.B.), Department of Medicine, and Division of Sleep and Circadian Disorders (M.K.P.), Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; and Arizona Respiratory Center (S.F.Q.), University of Arizona, Tucson.""}, {'ForeName': 'Milena K', 'Initials': 'MK', 'LastName': 'Pavlova', 'Affiliation': ""From the Divisions of Sleep and Circadian Disorders (R.B., S.J., L.J.E., O.O., S.F.Q.) and Pulmonary and Critical Care Medicine (R.B.), Department of Medicine, and Division of Sleep and Circadian Disorders (M.K.P.), Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; and Arizona Respiratory Center (S.F.Q.), University of Arizona, Tucson.""}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Epstein', 'Affiliation': ""From the Divisions of Sleep and Circadian Disorders (R.B., S.J., L.J.E., O.O., S.F.Q.) and Pulmonary and Critical Care Medicine (R.B.), Department of Medicine, and Division of Sleep and Circadian Disorders (M.K.P.), Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; and Arizona Respiratory Center (S.F.Q.), University of Arizona, Tucson.""}, {'ForeName': 'Olabimpe', 'Initials': 'O', 'LastName': 'Omobomi', 'Affiliation': ""From the Divisions of Sleep and Circadian Disorders (R.B., S.J., L.J.E., O.O., S.F.Q.) and Pulmonary and Critical Care Medicine (R.B.), Department of Medicine, and Division of Sleep and Circadian Disorders (M.K.P.), Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; and Arizona Respiratory Center (S.F.Q.), University of Arizona, Tucson.""}, {'ForeName': 'Stuart F', 'Initials': 'SF', 'LastName': 'Quan', 'Affiliation': ""From the Divisions of Sleep and Circadian Disorders (R.B., S.J., L.J.E., O.O., S.F.Q.) and Pulmonary and Critical Care Medicine (R.B.), Department of Medicine, and Division of Sleep and Circadian Disorders (M.K.P.), Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; and Arizona Respiratory Center (S.F.Q.), University of Arizona, Tucson.""}]",Neurology,['10.1212/WNL.0000000000008844']
2791,31619350,An exploratory study of vibration therapy on muscle function in patients with peripheral artery disease.,"OBJECTIVE


The purpose of this exploratory study was to determine whether a single session of vibration therapy (VT) would improve muscular and functional performance in individuals with symptomatic peripheral artery disease (PAD).
METHODS


In a randomized, balanced cross-over design fourteen PAD participants with intermittent claudication (mean ± standard deviation; age, 73.9 ± 4.6 years; height, 172.6 ± 68.4 cm; body mass, 85.2 ± 15.7 kg) performed VT and control that involved repeated chair rises, timed up-and-go test, and 6-minute walk test. Each intervention was separated by at least 2 days. Wearable VT devices were positioned on the right and left lower limbs that were turned on during functional testing but were turned off for the control intervention.
RESULTS


VT significantly improved (P < .05) repeated chair rises and timed up-and-go test compared with control with a small effect size of 0.46 and 0.45, respectively. Similarly, a significant (P < .01) and meaningful change in 6-minute walk test was noted in VT compared with control.
CONCLUSIONS


This exploratory study suggest that VT may enhance functional strength, mobility, and walking performance by extending the onset of claudication and increasing walking distance in PAD with intermittent claudication. However, further study is required to confirm and extend these preliminary findings and determine the potential mechanisms of action in VT.",2020,"RESULTS


VT significantly improved (P < .05) repeated chair rises and timed up-and-go test compared with control with a small effect size of 0.46 and 0.45, respectively.","['fourteen PAD participants with intermittent claudication (mean\xa0± standard deviation; age, 73.9\xa0± 4.6\xa0years; height, 172.6\xa0± 68.4\xa0cm; body mass, 85.2\xa0± 15.7\xa0kg) performed', 'patients with peripheral artery disease', 'individuals with symptomatic peripheral artery disease (PAD']","['VT and control that involved repeated chair rises, timed up-and-go test, and 6-minute walk test', 'VT', 'vibration therapy (VT', 'vibration therapy']","['meaningful change in 6-minute walk test', 'muscular and functional performance', 'functional strength, mobility, and walking performance', 'muscle function']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0021775', 'cui_str': 'Intermittent Claudication'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517764', 'cui_str': 'Four point six'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C3853978'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}]",14.0,0.0657549,"RESULTS


VT significantly improved (P < .05) repeated chair rises and timed up-and-go test compared with control with a small effect size of 0.46 and 0.45, respectively.","[{'ForeName': 'Darryl J', 'Initials': 'DJ', 'LastName': 'Cochrane', 'Affiliation': 'School of Sport, Exercise and Nutrition, Massey University, New Zealand. Electronic address: d.cochrane@massey.ac.nz.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Cochrane', 'Affiliation': 'Department of Vascular, Endovascular and Transplant Surgery, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Roake', 'Affiliation': 'Department of Vascular, Endovascular and Transplant Surgery, Christchurch Hospital, Christchurch, New Zealand; Department of Surgery, University of Otago, Christchurch, New Zealand.'}]",Journal of vascular surgery,['10.1016/j.jvs.2019.06.214']
2792,32049269,Effect of Reduced Exposure to Vasopressors on 90-Day Mortality in Older Critically Ill Patients With Vasodilatory Hypotension: A Randomized Clinical Trial.,"Importance


Vasopressors are commonly administered to intensive care unit (ICU) patients to raise blood pressure. Balancing risks and benefits of vasopressors is a challenge, particularly in older patients.
Objective


To determine whether reducing exposure to vasopressors through permissive hypotension (mean arterial pressure [MAP] target, 60-65 mm Hg) reduces mortality at 90 days in ICU patients aged 65 years or older with vasodilatory hypotension.
Design, Setting, and Participants


A multicenter, pragmatic, randomized clinical trial was conducted in 65 ICUs in the United Kingdom and included 2600 randomized patients aged 65 years or older with vasodilatory hypotension (assessed by treating clinician). The study was conducted from July 2017 to March 2019, and follow-up was completed in August 2019.
Interventions


Patients were randomized 1:1 to vasopressors guided either by MAP target (60-65 mm Hg, permissive hypotension) (n = 1291) or according to usual care (at the discretion of treating clinicians) (n = 1307).
Main Outcome and Measures


The primary clinical outcome was all-cause mortality at 90 days.
Results


Of 2600 randomized patients, after removal of those who declined or had withdrawn consent, 2463 (95%) were included in the analysis of the primary outcome (mean [SD] age 75 years [7 years]; 1387 [57%] men). Patients randomized to the permissive hypotension group had lower exposure to vasopressors compared with those in the usual care group (median duration 33 hours vs 38 hours; difference in medians, -5.0; 95% CI, -7.8 to -2.2 hours; total dose in norepinephrine equivalents median, 17.7 mg vs 26.4 mg; difference in medians, -8.7 mg; 95% CI, -12.8 to -4.6 mg). At 90 days, 500 of 1221 (41.0%) in the permissive hypotension compared with 544 of 1242 (43.8%) in the usual care group had died (absolute risk difference, -2.85%; 95% CI, -6.75 to 1.05; P = .15) (unadjusted relative risk, 0.93; 95% CI, 0.85-1.03). When adjusted for prespecified baseline variables, the odds ratio for 90-day mortality was 0.82 (95% CI, 0.68 to 0.98). Serious adverse events were reported for 79 patients (6.2%) in the permissive care group and 75 patients (5.8%) in the usual care group. The most common serious adverse events were acute renal failure (41 [3.2%] vs 33 [2.5%]) and supraventricular cardiac arrhythmia (12 [0.9%] vs 13 [1.0%]).
Conclusions and Relevance


Among patients 65 years or older receiving vasopressors for vasodilatory hypotension, permissive hypotension compared with usual care did not result in a statistically significant reduction in mortality at 90 days. However, the confidence interval around the point estimate for the primary outcome should be considered when interpreting the clinical importance of the study.
Trial Registration


isrctn.org Identifier: ISRCTN10580502.",2020,Serious adverse events were reported for 79 patients (6.2%) in the permissive care group and 75 patients (5.8%) in the usual care group.,"['July 2017 to March 2019, and follow-up was completed in August 2019', 'ICU patients aged 65 years or older with vasodilatory hypotension', 'patients 65 years or older receiving vasopressors for vasodilatory hypotension, permissive hypotension', '2600 randomized patients, after removal of those who declined or had withdrawn consent, 2463 (95%) were included in the analysis of the primary outcome (mean [SD] age 75 years [7 years]; 1387 [57%] men', '65 ICUs in the United Kingdom and included 2600 randomized patients aged 65 years or older with vasodilatory hypotension (assessed by treating clinician', 'older patients', 'Older Critically Ill Patients With Vasodilatory Hypotension']","['vasopressors guided either by MAP target (60-65 mm Hg, permissive hypotension) (n\u2009=\u20091291) or according to usual care (at the discretion of treating clinicians', 'Reduced Exposure to Vasopressors', 'permissive hypotension']","['lower exposure to vasopressors', 'mortality', 'odds ratio for 90-day mortality', 'acute renal failure', 'cause mortality', 'supraventricular cardiac arrhythmia', 'permissive hypotension', 'Serious adverse events', '90-Day Mortality']","[{'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C3645573', 'cui_str': 'Map target'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3854173', 'cui_str': 'Pre-renal acute kidney injury'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C1869051', 'cui_str': 'Cardiac arrhythmias (SMQ)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2600.0,0.284356,Serious adverse events were reported for 79 patients (6.2%) in the permissive care group and 75 patients (5.8%) in the usual care group.,"[{'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lamontagne', 'Affiliation': 'Université de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Richards-Belle', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Harrison', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': 'M Zia', 'Initials': 'MZ', 'LastName': 'Sadique', 'Affiliation': 'London School of Hygiene and Tropical Medicine, Department of Health Services Research and Policy, London, United Kingdom.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Grieve', 'Affiliation': 'London School of Hygiene and Tropical Medicine, Department of Health Services Research and Policy, London, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Camsooksai', 'Affiliation': 'Critical Care, Poole Hospital NHS Foundation Trust, Poole, Dorset, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Darnell', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Gordon', 'Affiliation': 'Division of Anaesthetics, Pain Medicine and Intensive Care, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'Henry', 'Affiliation': 'Patient representative, United Kingdom.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Hudson', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': 'Alexina J', 'Initials': 'AJ', 'LastName': 'Mason', 'Affiliation': 'London School of Hygiene and Tropical Medicine, Department of Health Services Research and Policy, London, United Kingdom.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Saull', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Whitman', 'Affiliation': 'Patient representative, United Kingdom.'}, {'ForeName': 'J Duncan', 'Initials': 'JD', 'LastName': 'Young', 'Affiliation': 'Kadoorie Centre for Critical Care Research and Education, University of Oxford, John Radcliffe Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Rowan', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Mouncey', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.0930']
2793,32139486,Acupuncture for insomnia with short sleep duration: protocol for a randomised controlled trial.,"INTRODUCTION


Insomnia with short sleep duration has a more serious negative impact on patient health. The existing literature suggests that medication therapy is more effective for this phenotype of insomnia compared with cognitive-behavioural therapy. However, the potential side effects of hypnotic medications hinder their clinical application. Acupuncture has been widely used in the treatment of insomnia, but it remains unclear whether it has therapeutic efficacy for insomnia with short sleep duration. The purpose of this trial is to evaluate the efficacy and safety of acupuncture for insomnia with short sleep duration.
METHODS AND ANALYSIS


This study is designed as a randomised, single-centre, single-blinded, placebo acupuncture controlled trial involving 152 participants. Eligible patients will be divided into two groups according to the objective total sleep time: insomnia with normal sleep duration group and insomnia with short sleep duration group. Then, patients in each group will be randomly assigned to two subgroups, the treatment group (acupuncture) and the control group (placebo acupuncture), in a 1:1 ratio with 38 subjects in each subgroup. The primary outcome is the Pittsburgh Sleep Quality Index and the Insomnia Severity Index. Secondary outcomes are actigraphy, the Beck Anxiety Inventory, the Beck Depression Inventory and the Fatigue Severity Scale. All adverse effects will be assessed by the Treatment Emergent Symptom Scale. Outcomes will be evaluated at baseline, post treatment, as well as at 1-week and 1-month follow-up.
ETHICS AND DISSEMINATION


This protocol has been approved by the ethics committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine (no. 2019-17). Written informed consent will be obtained from all participants. The results will be disseminated through peer-reviewed journals for publications.
TRIAL REGISTRATION NUMBER


ChiCTR1900023473; Pre-results.",2020,Eligible patients will be divided into two groups according to the objective total sleep time: insomnia with normal sleep duration group and insomnia with short sleep duration group.,"['Eligible patients', '152 participants']","['acupuncture', 'Acupuncture', 'treatment group (acupuncture) and the control group (placebo acupuncture', 'placebo acupuncture', 'normal sleep duration group and insomnia with short sleep duration group']","['actigraphy, the Beck Anxiety Inventory, the Beck Depression Inventory and the Fatigue Severity Scale', 'efficacy and safety', 'Pittsburgh Sleep Quality Index and the Insomnia Severity Index', 'objective total sleep time: insomnia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory (assessment scale)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]",152.0,0.14388,Eligible patients will be divided into two groups according to the objective total sleep time: insomnia with normal sleep duration group and insomnia with short sleep duration group.,"[{'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Wen-Jia', 'Initials': 'WJ', 'LastName': 'Yang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Xin-Tong', 'Initials': 'XT', 'LastName': 'Yu', 'Affiliation': 'Laboratory Center of Medicine, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Fu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jin-Jin', 'Initials': 'JJ', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Wen-Lin', 'Initials': 'WL', 'LastName': 'Xu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Yi-Xin', 'Initials': 'YX', 'LastName': 'Zheng', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Xin-yu', 'Initials': 'XY', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Yun-Fei', 'Initials': 'YF', 'LastName': 'Chen', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China icyf1968@163.com.'}]",BMJ open,['10.1136/bmjopen-2019-033731']
2794,30902690,Effect of initial airway strategy on time to epinephrine administration in patients with out-of-hospital cardiac arrest.,"INTRODUCTION


Epinephrine and advanced airway management are commonly used during treatment of out-of-hospital cardiac arrest (OHCA). Recent studies suggest that early but not late administration of epinephrine is associated with improved survival. The purpose of this study was to evaluate the effect of initial airway strategy on timing to the first epinephrine dose in OHCA.
METHODS


This is a secondary analysis of patients enrolled in the Pragmatic Airway Resuscitation Trial who had an advanced airway attempted. We examined differences in time to epinephrine administration by randomly assigned airway strategy, laryngeal tube (LT) or endotracheal tube (ETI); by the duration of airway attempt; and by number of attempts. We used survival methods to account for interval censoring due to unknown administration time. We also examined the association of epinephrine administration timing with survival to hospital discharge.
RESULTS


Among 2652 subjects (1299 ETI and 1353 LT), 2579 received epinephrine.There were no significant differences between ETI and LT in median time to initial epinephrine administration (min) (ETI - 9.0 vs. LT - 8.6, p = 0.55). There was no significant association between the duration of airway attempt or number of attempts and time to initial epinephrine administration (p = 0.12 and 0.66, respectively). Early administration of epinephrine (<10 min from EMS arrival) was significantly associated with survival compared to administration ≥10 min (OR 1.36, 95% CI: 1.05, 1.77).
CONCLUSIONS


There was no significant association between airway strategy and time to initial epinephrine administration. Earlier administration of epinephrine (< 10 min from EMS arrival) was associated with improved survival.",2019,"Early administration of epinephrine (<10 min from EMS arrival) was significantly associated with survival compared to administration ≥10 min (OR 1.36, 95% CI: 1.05, 1.77).
","['patients with out-of-hospital cardiac arrest', 'patients enrolled in the Pragmatic Airway Resuscitation Trial who had an advanced airway attempted', '2652 subjects (1299 ETI and 1353 LT), 2579 received']","['Epinephrine', 'epinephrine', 'laryngeal tube (LT) or endotracheal tube (ETI']","['survival', 'duration of airway attempt or number of attempts and time to initial epinephrine administration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube, device (physical object)'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]",2652.0,0.109242,"Early administration of epinephrine (<10 min from EMS arrival) was significantly associated with survival compared to administration ≥10 min (OR 1.36, 95% CI: 1.05, 1.77).
","[{'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lupton', 'Affiliation': 'Oregon Health and Science University United States. Electronic address: lupton@ohsu.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schmicker', 'Affiliation': 'University of Washington United States. Electronic address: rschmick@uw.edu.'}, {'ForeName': 'Mohamud R', 'Initials': 'MR', 'LastName': 'Daya', 'Affiliation': 'Oregon Health and Science University United States. Electronic address: dayam@ohsu.edu.'}, {'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Aufderheide', 'Affiliation': 'Medical College of Wisconsin United States. Electronic address: taufderh@mcw.edu.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Stephens', 'Affiliation': 'University of Alabama at Birmingham United States. Electronic address: swstephens@uabmc.edu.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Le', 'Affiliation': 'Oregon Health and Science University United States. Electronic address: lena@ohsu.edu.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'May', 'Affiliation': 'University of Washington United States. Electronic address: sjmay@uw.edu.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Puyana', 'Affiliation': 'University of Pittsburgh United States. Electronic address: puyanajj@upmc.edu.'}, {'ForeName': 'Ahamed', 'Initials': 'A', 'LastName': 'Idris', 'Affiliation': 'University of Texas Southwestern United States. Electronic address: aidris@sbcglobal.net.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Nichol', 'Affiliation': 'University of Washington United States. Electronic address: nichol@uw.edu.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'University of Texas Health Science Center United States. Electronic address: henry.e.wang@uth.tmc.edu.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Hansen', 'Affiliation': 'Oregon Health and Science University United States. Electronic address: hansemat@ohsu.edu.'}]",Resuscitation,['10.1016/j.resuscitation.2019.03.015']
2795,32108889,Effect of Adding a Work-Focused Intervention to Integrated Care for Depression in the Veterans Health Administration: A Randomized Clinical Trial.,"Importance


Thousands of working-age veterans with depression experience impaired occupational functioning.
Objectives


To test whether the Veterans Health Administration (VHA) integrated care (IC) program combined with telephonic work-focused counseling, known as Be Well at Work (BWAW), is superior to IC alone for improving occupational functioning and depression, to determine whether these effects persist 4 months later, and to determine whether the return on investment is positive.
Design, Setting, and Participants


In this randomized clinical trial conducted from October 21, 2014, to December 6, 2019, patients undergoing IC at VHA facilities were screened for eligibility and randomized to IC alone or IC plus BWAW. Blinded interviewers administered questionnaires before the intervention, immediately after completion of the intervention at month 4, and at month 8. Eligibility criteria were individuals 18 years or older who were working at least 15 hours per week in a job they had occupied for at least 6 months, were experiencing work limitations, and had current major depressive disorder or persistent depressive disorder. Exclusion criteria were individuals who could not read or speak English, had planned maternity leave, or had a history of bipolar disorder or psychosis. Data analyses were conducted from January 1, 2018, to December 6, 2019.
Interventions


Integrated care is multidisciplinary depression care involving screening, clinical informatics, measurement-based care, brief behavioral interventions, and referral as needed to specialty mental health care. Be Well at Work counseling involves 8 biweekly telephone sessions and 1 telephone booster visit after 4 months. Doctoral-level psychologists helped patients to identify barriers to functioning and to adopt new work-focused cognitive-behavioral and work-modification strategies.
Main Outcomes and Measures


The primary outcome was the adjusted mean group difference in changes from before to after intervention (hereafter, adjusted effect) in the percentage of at-work productivity loss, measured with the Work Limitations Questionnaire (range, 0%-25%). The secondary outcome was adjusted effect in the Patient Health Questionnaire 9-item symptom severity score (range, 0-27, with 0 indicating no symptoms and 27, severe symptoms).
Results


Of 670 veterans referred for participation, 287 veterans (42.8%) consented and completed eligibility screening, and 253 veterans (37.8%) were randomized. Among these 253 patients (mean [SD] age, 45.7 [11.6] years; 218 [86.2%] men; 135 [53.4%] white), 114 (45.1%) were randomized to IC and 139 (54.9%) were randomized to IC plus BWAW. At the 4-month follow-up, patients who received IC plus BWAW had greater reductions in at-work productivity loss (adjusted effect, -1.7; 95% CI, -3.1 to -0.4; P = .01) and depression symptom severity (adjusted effect, -2.1; 95% CI, -3.5 to -0.7; P = .003). The improvements from IC plus BWAW persisted 4 months after intervention (at-work productivity loss mean difference, -0.5; 95% CI, -1.9 to 0.9; P = .46; depression symptom severity mean difference, 0.6; 95% CI -0.9 to 2.1; P = .44). The cost per patient participating in BWAW was $690.98, and the return on investment was 160%.
Conclusions and Relevance


These findings suggest that adding this work-focused intervention to IC improves veterans' occupational and psychiatric outcomes, reducing obstacles to having a productive civilian life.
Trial Registration


ClinicalTrials.gov Identifier: NCT02111811.",2020,"At the 4-month follow-up, patients who received IC plus BWAW had greater reductions in at-work productivity loss (adjusted effect, -1.7; 95% CI, -3.1 to -0.4; P = .01) and depression symptom severity (adjusted effect, -2.1; 95% CI, -3.5 to -0.7; P = .003).","['253 patients (mean [SD] age, 45.7 [11.6] years; 218 [86.2%] men; 135 [53.4%] white), 114 (45.1%) were randomized to IC and 139 (54.9', '670 veterans referred for participation, 287 veterans (42.8%) consented and completed eligibility screening, and 253 veterans (37.8%) were randomized', 'Exclusion criteria were individuals who could not read or speak English, had planned maternity leave, or had a history of bipolar disorder or psychosis', 'working-age veterans with depression experience impaired occupational functioning', 'Eligibility criteria were individuals 18 years or older who were working at least 15 hours per week in a job they had occupied for at least 6 months, were experiencing work limitations, and had current major depressive disorder or persistent depressive disorder', 'from October 21, 2014, to December 6, 2019, patients undergoing IC at VHA facilities']","['IC alone or IC plus BWAW', 'Work-Focused Intervention to Integrated Care', 'Veterans Health Administration (VHA) integrated care (IC) program combined with telephonic work-focused counseling, known as Be Well at Work (BWAW']","['work productivity loss', 'Patient Health Questionnaire 9-item symptom severity score (range, 0-27, with 0 indicating no symptoms and 27, severe symptoms', 'percentage of at-work productivity loss, measured with the Work Limitations Questionnaire', 'depression symptom severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C4517853', 'cui_str': '670'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C4517682', 'cui_str': '287 (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0332315', 'cui_str': 'Has plan (attribute)'}, {'cui': 'C0557441', 'cui_str': 'On maternity leave (finding)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0556976', 'cui_str': 'hours/week (qualifier value)'}, {'cui': 'C0028811', 'cui_str': 'Occupations'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4087263', 'cui_str': 'Persistent depressive disorder'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0178672', 'cui_str': 'Health administration'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}]","[{'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",,0.177996,"At the 4-month follow-up, patients who received IC plus BWAW had greater reductions in at-work productivity loss (adjusted effect, -1.7; 95% CI, -3.1 to -0.4; P = .01) and depression symptom severity (adjusted effect, -2.1; 95% CI, -3.5 to -0.7; P = .003).","[{'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Lerner', 'Affiliation': 'Program on Health, Work and Productivity, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, and Tufts University School of Medicine and Tufts Graduate School of Biomedical Sciences, Boston, Massachusetts.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Adler', 'Affiliation': 'Program on Health, Work and Productivity, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, and Tufts University School of Medicine and Tufts Graduate School of Biomedical Sciences, Boston, Massachusetts.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Rogers', 'Affiliation': 'Program on Health, Work and Productivity, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, and Tufts University School of Medicine and Tufts Graduate School of Biomedical Sciences, Boston, Massachusetts.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Ingram', 'Affiliation': 'Veterans Integrated Service Network 4 Mental Illness Research, Education, and Clinical Center, Center of Excellence, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Oslin', 'Affiliation': 'Veterans Integrated Service Network 4 Mental Illness Research, Education, and Clinical Center, Center of Excellence, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.0075']
2796,31821592,Dialectical behavior therapy self-help for binge-eating disorder: A randomized controlled study.,"OBJECTIVE


The objective of this study was to compare the relative effectiveness of dialectical behavior therapy guided self-help (DBT-GSH) and DBT unguided self-help (DBT-USH) with an unguided self-help control condition in the treatment of binge-eating disorder (BED).
METHOD


Seventy-one participants who met diagnostic criteria for BED based on Eating Disorder Examination (EDE) interview were randomly assigned to DBT-GSH, DBT-USH or active control USH for 12 weeks. Assessments took place at baseline, 12 weeks and 3-month follow-up. Outcome measures included the EDE to assess binge frequency, the EDE-Questionnaire (EDE-Q), the Brief Symptom Inventory, and the Short Form 6D.
RESULTS


The overall completion rate was 65% at post-treatment and 63% at 3-month follow-up. Intention to treat analyses showed that participants in all three conditions reported significant reductions in binge frequency with large effect sizes. A similar pattern emerged for secondary outcome variables including eating disorder psychopathology, general psychological distress, and health-related quality of life.
DISCUSSION


Self-help may be an effective way to disseminate DBT for BED. However, future research should evaluate DBT self-help using a larger sample size, possibly in a multisite design.",2020,Intention to treat analyses showed that participants in all three conditions reported significant reductions in binge frequency with large effect sizes.,"['binge-eating disorder', 'Seventy-one participants who met diagnostic criteria for BED based on Eating Disorder Examination (EDE) interview', 'binge-eating disorder (BED']","['DBT-GSH, DBT-USH or active control USH', 'Dialectical behavior therapy self-help', 'dialectical behavior therapy guided self-help (DBT-GSH) and DBT unguided self-help (DBT-USH', 'unguided self-help control condition']","['binge frequency', 'overall completion rate', 'eating disorder psychopathology, general psychological distress, and health-related quality of life', 'EDE to assess binge frequency, the EDE-Questionnaire (EDE-Q), the Brief Symptom Inventory, and the Short Form 6D']","[{'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0450389', 'cui_str': '71 (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2732388', 'cui_str': 'Eating disorder examination'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1321145', 'cui_str': 'Dialectical Behavior Therapy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]",71.0,0.0940335,Intention to treat analyses showed that participants in all three conditions reported significant reductions in binge frequency with large effect sizes.,"[{'ForeName': 'Jacqueline C', 'Initials': 'JC', 'LastName': 'Carter', 'Affiliation': ""Department of Psychology, Memorial University of Newfoundland, St. John's, Newfoundland and Labrador, Canada.""}, {'ForeName': 'Therese E', 'Initials': 'TE', 'LastName': 'Kenny', 'Affiliation': 'Department of Psychology, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Singleton', 'Affiliation': ""Department of Psychology, Memorial University of Newfoundland, St. John's, Newfoundland and Labrador, Canada.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Van Wijk', 'Affiliation': ""Department of Psychology, Memorial University of Newfoundland, St. John's, Newfoundland and Labrador, Canada.""}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Heath', 'Affiliation': ""Faculty of Medicine, Memorial University of Newfoundland, St. John's, Newfoundland and Labrador, Canada.""}]",The International journal of eating disorders,['10.1002/eat.23208']
2797,32169093,"Comparison of Instrumental Activities of Daily Living assessment by face-to-face or telephone interviews: a randomized, crossover study.","BACKGROUND


The functional autonomy assessment is essential to manage patients with a neurodegenerative disease, but its evaluation is not always possible during a consultation. To optimize ambulatory autonomy assessment, we compared the Lawton Instrumental Activities of Daily Living (IADL) questionnaire collected by telephone and face-to-face interviews.
METHODS


A randomized, crossover study was carried out among patients attending a memory clinic (MC). The IADL questionnaire was collected for patients during telephone and face-to-face interviews between nurses and patients' caregivers. The agreement between the two methods was measured using the proportion of participants giving the same response, Cohen's kappa, intraclass correlation (ICC) coefficient, and Bland and Altman method. The associations between patients' characteristics, events occurring between the two assessments, and agreement were assessed.
RESULTS


Among the 292 patients (means ± SD age 81.5 ± 7, MMSE 19.6 ± 6, 39.7% with major neurocognitive disorders) analyzed, the proportion of agreement between the two modes was 89.4% for the total IADL score. Weighted kappa coefficient was 0.66 and ICC score was 0.91 for total IADL score. The mean difference between the IADL score by telephone or face-to-face was 0.32. Overall, 96.9% of measures lay within the 95% limits of agreement. The occurrence of fall was less likely associated with the probability to lie within the 95% limits of agreement (OR = 0.07 [0.02-0.27]).
CONCLUSION


The administration of IADL by telephone with the caregiver appears to be an acceptable method of assessment for MC patients compared to face-to-face interview. The events such as falls which could occur in a time close to the evaluation should be reported.
STUDY REGISTRATION


ClinicalTrials.gov, NCT02654574. Retrospectively registered: 13 January 2016.",2020,"The occurrence of fall was less likely associated with the probability to lie within the 95% limits of agreement (OR = 0.07 [0.02-0.27]).
","['292 patients (means\u2009±\u2009SD age 81.5\u2009±\u20097, MMSE 19.6\u2009±\u20096, 39.7% with major neurocognitive disorders', 'patients with a neurodegenerative disease', 'patients attending a memory clinic (MC']",['Instrumental Activities of Daily Living assessment by face-to-face or telephone interviews'],"['Lawton Instrumental Activities of Daily Living (IADL) questionnaire', 'IADL score', 'Weighted kappa coefficient', 'total IADL score', 'IADL questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C4087461', 'cui_str': 'Major neurocognitive disorder'}, {'cui': 'C0524851', 'cui_str': 'Degenerative Neurologic Disorders'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C1161154', 'cui_str': 'Assess instrumental activities of daily living (IADLS)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}]","[{'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.024528,"The occurrence of fall was less likely associated with the probability to lie within the 95% limits of agreement (OR = 0.07 [0.02-0.27]).
","[{'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Dauphinot', 'Affiliation': 'Memory Clinical and Research Center of Lyon (CMRR), Lyon Institute For Elderly, Hospices Civils de Lyon, Lyon, France. virginie.dauphinot@chu-lyon.fr.'}, {'ForeName': 'Nawèle', 'Initials': 'N', 'LastName': 'Boublay', 'Affiliation': 'Memory Clinical and Research Center of Lyon (CMRR), Lyon Institute For Elderly, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Moutet', 'Affiliation': 'Memory Clinical and Research Center of Lyon (CMRR), Lyon Institute For Elderly, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Achi', 'Affiliation': 'Memory Clinical and Research Center of Lyon (CMRR), Lyon Institute For Elderly, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Bathsavanis', 'Affiliation': 'Memory Clinical and Research Center of Lyon (CMRR), Lyon Institute For Elderly, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Krolak-Salmon', 'Affiliation': 'Memory Clinical and Research Center of Lyon (CMRR), Lyon Institute For Elderly, Hospices Civils de Lyon, Lyon, France.'}]",Alzheimer's research & therapy,['10.1186/s13195-020-00590-w']
2798,30809700,Remotely programmed sacral neuromodulation for the treatment of patients with refractory overactive bladder: a prospective randomized controlled trial evaluating the safety and efficacy of a novel sacral neuromodulation device.,"PURPOSE


The efficacy and safety of a novel remotely programmed BetterStim sacral neuromodulation (SNM) system was evaluated in patients with refractory overactive bladder (OAB) in a prospective, controlled, multicenter trial.
METHODS


A total of 84 patients referred for SNM therapy from October 2015 to January 2018 were studied. Of the patients who qualified for implantation, 37 and 33 were randomly assigned to treatment and control groups, respectively. Patients in the treatment group underwent stimulation upon implantation, while stimulation was delayed in the control group for 3 months. Follow-up visits, consisting of voiding diary outcome, questionnaires regarding overactive bladder symptom score (OABSS) and quality of life were conducted at 1, 3, and 6-month post-implantation.
RESULTS


Compared with the control group, subjects in the treatment group exhibited statistically significant improvement in OAB symptoms at 3 months. The overall success rate was achieved in 72% of the treatment group, compared with 12% of the control group at 3 months. At 6 months, there were no significant differences in key voiding diary variables between the two groups. Further, this study demonstrated sustained improvement in urinary symptom interference in OAB patients. In addition, nearly all patients expressed great satisfaction with the remote-programming methods. No serious adverse events occurred, and device-related adverse events rate was 12.86%.
CONCLUSION


This clinical study demonstrates subjective and objective success of the BetterStim SNM system. Importantly, our data suggest that remote programming can be safely used as a viable option for the conventional programming with a high degree of patient satisfaction.",2019,"The overall success rate was achieved in 72% of the treatment group, compared with 12% of the control group at 3 months.","['patients with refractory overactive bladder (OAB', 'patients who qualified for implantation, 37 and 33', 'patients with refractory overactive bladder', '84 patients referred for SNM therapy from October 2015 to January 2018 were studied', 'OAB patients']","['Remotely programmed sacral neuromodulation', 'novel remotely programmed BetterStim sacral neuromodulation (SNM) system', 'novel sacral neuromodulation device']","['adverse events rate', 'urinary symptom interference', 'voiding diary outcome, questionnaires regarding overactive bladder symptom score (OABSS) and quality of life', 'key voiding diary variables', 'overall success rate', 'OAB symptoms', 'efficacy and safety', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",84.0,0.0365936,"The overall success rate was achieved in 72% of the treatment group, compared with 12% of the control group at 3 months.","[{'ForeName': 'Yaoguang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Urology Department, Beijing Hospital, National Center of Gerontology, No. 1 DaHua Road, Dong Dan, Beijing, 100730, People's Republic of China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""Urology Department, Beijing Chaoyang Hospital, Capital Medical University, Beijing, 100020, People's Republic of China.""}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Tian', 'Affiliation': ""Urology Department, Peking University Third Hospital, Beijing, 100191, People's Republic of China.""}, {'ForeName': 'Guoqing', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': ""Urology Department, China Rehabilitation Research Center, Capital Medical University, No. 10 North Road, Fengtai District, Beijing, 100068, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Urology Department, Qilu Hospital, Shandong University, Jinan, Shandong, 250012, People's Republic of China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Urology Department, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100050, People's Republic of China.""}, {'ForeName': 'Zhihui', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': ""Urology Department, Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, 310014, People's Republic of China.""}, {'ForeName': 'Zhongqing', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': ""Urology Department, Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210000, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Urology Department, Beijing Hospital, National Center of Gerontology, No. 1 DaHua Road, Dong Dan, Beijing, 100730, People's Republic of China.""}, {'ForeName': 'Lulin', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': ""Urology Department, Peking University Third Hospital, Beijing, 100191, People's Republic of China.""}, {'ForeName': 'Benkang', 'Initials': 'B', 'LastName': 'Shi', 'Affiliation': ""Urology Department, Qilu Hospital, Shandong University, Jinan, Shandong, 250012, People's Republic of China.""}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Liao', 'Affiliation': ""Urology Department, China Rehabilitation Research Center, Capital Medical University, No. 10 North Road, Fengtai District, Beijing, 100068, People's Republic of China. lmliao@263.net.""}, {'ForeName': 'Jianye', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Urology Department, Beijing Hospital, National Center of Gerontology, No. 1 DaHua Road, Dong Dan, Beijing, 100730, People's Republic of China. jianye_wangbhp@126.com.""}]",World journal of urology,['10.1007/s00345-019-02698-7']
2799,31469233,Greater trochanteric pain syndrome in the UK National Health Service: A multicentre service evaluation.,"PURPOSE


Greater trochanteric pain syndrome (GTPS) is a debilitating condition causing lateral hip pain. A recent randomized controlled trial (LEAP) demonstrated that exercise interventions for GTPS provided superior outcomes, compared with corticosteroid injection and wait-and-see approaches. However, participants were not patients seeking care and therefore may not have represented the typical patient seen within the National Health Service (NHS). The present service evaluation aimed to provide data on the characteristics of patients with GTPS presenting to NHS physiotherapy services, to enable consideration of the applicability of the findings of the LEAP trial to patients seeking care within the NHS.
METHODS


Four NHS sites provided anonymized data on patients presenting to their service with a primary complaint of GTPS.
RESULTS


The data from 162 patients suggested that the typical patients presenting to the NHS with GTPS are female (73%), overweight (body mass index 28.5) and experiencing a 12-month or longer history of lateral hip pain (56.8%). Patients reported high levels of pain (visual analogue score 6.5), low health-related quality of life (EuroQol five-dimensions - 5-level score 0.6), coexisting medical conditions (79.0%) and high medication use (82.7%).
CONCLUSIONS


Patients presenting to the NHS with GTPS appear to have multifactorial issues, with high levels of pain and disability, and are often medicated for multiple coexisting conditions. These characteristics differentiate them from patients recruited to the LEAP trial. Hence, it is unclear whether the findings of the LEAP trial are applicable to patients with GTPS who consult physiotherapy services in the NHS. Further research is warranted to evaluate this.",2019,"Patients reported high levels of pain (visual analogue score 6.5), low health-related quality of life (EuroQol five-dimensions - 5-level score 0.6), coexisting medical conditions (79.0%) and high medication use (82.7%).
","['patients with GTPS presenting to NHS physiotherapy services', 'UK National Health Service', 'patients presenting to their service with a primary complaint of GTPS', 'Patients presenting to the NHS with', 'patients with GTPS who consult physiotherapy services in the NHS', '162 patients suggested that the typical patients presenting to the NHS with GTPS are female (73%), overweight (body mass index 28.5) and experiencing a 12-month or longer history of lateral hip pain (56.8', 'patients seeking care within the NHS']",['GTPS'],"['high levels of pain (visual analogue score 6.5), low health-related quality of life (EuroQol five-dimensions - 5-level score 0.6), coexisting medical conditions', 'trochanteric pain syndrome']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0587629', 'cui_str': 'Physical medicine service (procedure)'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0018353', 'cui_str': 'GTP'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0019559', 'cui_str': 'Hip pain (finding)'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]",162.0,0.0564596,"Patients reported high levels of pain (visual analogue score 6.5), low health-related quality of life (EuroQol five-dimensions - 5-level score 0.6), coexisting medical conditions (79.0%) and high medication use (82.7%).
","[{'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Stephens', 'Affiliation': 'The Royal Orthopaedic Hospital, Birmingham, UK.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': ""O'Neill"", 'Affiliation': 'University of Leicester, Leicester, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Clifford', 'Affiliation': 'Gartnavel General Hospital, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Cuff', 'Affiliation': 'Wakefield Musculoskeletal Service, Trinity Medical Centre, Wakefield, UK.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Forte', 'Affiliation': 'Sandwell and West Birmingham NHS Hospitals, West Bromwich, UK.'}, {'ForeName': 'Catrin', 'Initials': 'C', 'LastName': 'Hawthorn', 'Affiliation': 'Glangwili Hospital, Carmarthen, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Littlewood', 'Affiliation': 'Primary Care Centre versus Arthritis, Research Institute for Primary Care and Health Sciences, Keele University, Staffordshire, UK.'}]",Musculoskeletal care,['10.1002/msc.1419']
2800,31711880,"Dorsomedial prefrontal cortex repetitive transcranial magnetic stimulation for treatment-refractory major depressive disorder: A three-arm, blinded, randomized controlled trial.","BACKGROUND


Dorsomedial prefrontal cortex (DMPFC) repetitive transcranial magnetic stimulation (rTMS) is a novel intervention for treatment-refractory depression (TRD). To date, many open-label case series and one randomized controlled trial of modest sample size have provided preliminary evidence that DMPFC-rTMS is an effective treatment for TRD. Here, we report the results of a large, double-blinded, sham-controlled trial of DMPFC-rTMS for TRD.
OBJECTIVE


The primary aim of this study was to determine the efficacy of DMPFC-rTMS for TRD under sham-controlled conditions.
METHODS


120 TRD patients were randomized to receive 30 twice-daily sessions of either active high-frequency, active low-frequency, or sham DMPFC-rTMS using a novel bent active/sham double-cone coil. Placebo stimulation also involved the use of surface electrodes placed above the eyebrows. The 17-item Hamilton Rating Scale for Depression served as the primary outcome measure.
RESULTS


Although there was a significant main effect of treatment across all arms, active DMPFC-rTMS was not superior to sham. Both participants and assessors were unable to accuracy determine whether patients received active or placebo stimulation. However, technicians' treatment arm guesses were significantly above chance.
CONCLUSION


DMPFC rTMS did not result in improvement of depressive symptoms greater than sham stimulation. We cannot rule out that the sham apparatus may also have elicited an antidepressant effect via electrical trigeminal stimulation; future DMPFC-rTMS trials are therefore warranted.",2020,"Although there was a significant main effect of treatment across all arms, active DMPFC-rTMS was not superior to sham.","['120 TRD patients', 'treatment-refractory major depressive disorder']","['Placebo', 'DMPFC-rTMS', 'DMPFC rTMS', 'Dorsomedial prefrontal cortex (DMPFC) repetitive transcranial magnetic stimulation (rTMS', 'Dorsomedial prefrontal cortex repetitive transcranial magnetic stimulation', '30 twice-daily sessions of either active high-frequency, active low-frequency, or sham DMPFC-rTMS using a novel bent active/sham double-cone coil', 'placebo stimulation']","['depressive symptoms', '17-item Hamilton Rating Scale']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0393983', 'cui_str': 'Cerebellar Herniation'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0222045'}]",120.0,0.64827,"Although there was a significant main effect of treatment across all arms, active DMPFC-rTMS was not superior to sham.","[{'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Dunlop', 'Affiliation': 'Feil Family Brain and Mind Research Institute, Weill Cornell Medical College, New York City, United States. Electronic address: kad2032@med.cornell.edu.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Sheen', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Schulze', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fettes', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Farrokh', 'Initials': 'F', 'LastName': 'Mansouri', 'Affiliation': 'Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Kfir', 'Initials': 'K', 'LastName': 'Feffer', 'Affiliation': 'Lev-Hasharon Mental Health Center, Tzur-Moshe, Israel; Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, Canada; Department of Psychiatry, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, Canada; Department of Psychiatry, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Sidney H', 'Initials': 'SH', 'LastName': 'Kennedy', 'Affiliation': ""Institute of Medical Science, University of Toronto, Toronto, Canada; Department of Psychiatry, University of Toronto, Toronto, Canada; Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada; Krembil Research Institute, University Health Network, Toronto, Canada.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Giacobbe', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, Canada; Department of Psychiatry, University of Toronto, Toronto, Canada; Department of Psychiatry, University Health Network, Toronto, Canada; Harquail Centre for Neuromodulation, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Blake', 'Initials': 'B', 'LastName': 'Woodside', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, Canada; Department of Psychiatry, University Health Network, Toronto, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Downar', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, Canada; Department of Psychiatry, University of Toronto, Toronto, Canada; Department of Psychiatry, University Health Network, Toronto, Canada; Krembil Research Institute, University Health Network, Toronto, Canada.'}]",Brain stimulation,['10.1016/j.brs.2019.10.020']
2801,32108888,Effect of a Physiotherapist-Guided Home-Based Exercise Intervention on Physical Capacity and Patient-Reported Outcomes Among Patients With Acute Pulmonary Embolism: A Randomized Clinical Trial.,"Importance


Survivors of acute pulmonary embolism (PE) experience long-term negative physical and mental consequences, but the effects of rehabilitation on outcomes among these patients have not been investigated.
Objective


To investigate the effect of a rehabilitation intervention, comprising an 8-week home-based exercise program and nurse consultations, on physical capacity and patient-reported outcomes among patients with acute PE.
Design, Setting, and Participants


This multicenter randomized clinical superiority trial was conducted at 4 regional hospitals and 1 university hospital in Denmark. The 140 consecutively included participants had been diagnosed with an acute PE between April 2016 and February 2018 and had 6 months of follow-up. An intention-to-treat analysis was conducted.
Intervention


Patients in the control group received a brief nurse consultation, while patients in the exercise group participated in an 8-week home-based exercise program in addition to receiving nurse consultations.
Main Outcomes and Measures


The primary outcome was the Incremental Shuttle Walk Test, and secondary outcomes were the Pulmonary Embolism Quality of Life and the EuroQol-5 Dimensions-3 Levels questionnaires, self-reported number of sick-leave days, and self-reported use of psychotropic drugs.
Results


A total of 140 patients (90 [64.3%] men) were included, with a mean (SD) age of 61 (11) years. Of 70 participants (50.0%) randomized to each group, 69 participants (49.3%) received the intervention and 68 (48.6%) received the control intervention. Both groups achieved improvements in all outcomes (eg, mean [SD] improvement on Incremental Shuttle Walk Test: control group, 78 (127) m; intervention group, 104 [106] m; median [interquartile range] improvement on Pulmonary Embolism Quality of Life: control group, -17 [-22 to -11] points; intervention group, -20 [-24 to -15] points). Between-group differences were nonsignificant. The mean differences between the intervention group and the control group were 25 m (95% CI, -20 to 70 m; P = .27) on the Incremental Shuttle Walk Test, 3.0 points (95% CI, -3.7 to 9.9 points; P = .39) on the Pulmonary Embolism Quality of Life questionnaire, and 0.017 point (95% CI, -0.032 to 0.065 point; P = .50) on the EuroQol-5 Dimensions-3 Levels questionnaire. Of the 27 patients in the intervention group on sick leave at baseline, 24 (88.9%) reported fit-for-duty at the 6-month follow-up, and of 18 patients in the control group on sick leave, 17 (94.4%) reported fit-for-duty at the 6-month follow up. The between-group risk difference was not significant (5.5 points; P = .49).
Conclusions and Relevance


An 8-week rehabilitation intervention with exercise added to nurse consultations did not show significantly better outcomes than nurse consultations alone. However, because of a ceiling effect on the primary outcome of physical capacity and an inclusion of patients with a low comorbidity burden and low PE disease severity, definitive conclusions could not be drawn. Initiating an exercise intervention shortly after pulmonary embolism was safe and without adverse events.
Trial Registration


ClinicalTrials.gov Identifier: NCT02684721.",2020,"Both groups achieved improvements in all outcomes (eg, mean [SD] improvement on Incremental Shuttle Walk Test: control group, 78 (127) m; intervention group, 104 [106] m; median [interquartile range] improvement on Pulmonary Embolism Quality of Life: control group, -17","['140 consecutively included participants had been diagnosed with an acute PE between April 2016 and February 2018 and had 6 months of follow-up', 'patients with acute PE.\nDesign, Setting, and Participants', '4 regional hospitals and 1 university hospital in Denmark', '140 patients (90 [64.3%] men) were included, with a mean (SD) age of 61 (11) years', 'Patients With Acute Pulmonary Embolism']","['rehabilitation intervention', 'brief nurse consultation, while patients in the exercise group participated in an 8-week home-based exercise program in addition to receiving nurse consultations', 'Physiotherapist-Guided Home-Based Exercise Intervention', 'control intervention']","['Pulmonary Embolism Quality of Life', 'sick leave', 'Pulmonary Embolism Quality of Life questionnaire', 'Incremental Shuttle Walk Test, and secondary outcomes were the Pulmonary Embolism Quality of Life and the EuroQol-5 Dimensions-3 Levels questionnaires, self-reported number of sick-leave days, and self-reported use of psychotropic drugs', 'Physical Capacity and Patient-Reported Outcomes', 'EuroQol-5 Dimensions-3 Levels questionnaire']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2882221', 'cui_str': 'Acute pulmonary embolism'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0034380'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4280053', 'cui_str': 'Incremental Shuttle Walk Test'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0033978', 'cui_str': 'Psychoactive Drugs'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]",140.0,0.125402,"Both groups achieved improvements in all outcomes (eg, mean [SD] improvement on Incremental Shuttle Walk Test: control group, 78 (127) m; intervention group, 104 [106] m; median [interquartile range] improvement on Pulmonary Embolism Quality of Life: control group, -17","[{'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Rolving', 'Affiliation': 'Diagnostic Center, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'Brocki', 'Affiliation': 'Department of Occupational Therapy and Physiotherapy, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jannie R', 'Initials': 'JR', 'LastName': 'Bloch-Nielsen', 'Affiliation': 'Diagnostic Center, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Torben B', 'Initials': 'TB', 'LastName': 'Larsen', 'Affiliation': 'Thrombosis and Drug Research Unit, Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Jensen', 'Affiliation': 'Department of Physical and Occupational Therapy, Regional Hospital Herning, Herning, Denmark.'}, {'ForeName': 'Hanne R', 'Initials': 'HR', 'LastName': 'Mikkelsen', 'Affiliation': 'Diagnostic Center, Department of Cardiology, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Ravn', 'Affiliation': 'Diagnostic Center, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Frost', 'Affiliation': 'Diagnostic Center, Department of Cardiology, Silkeborg Regional Hospital, Silkeborg, Denmark.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.0064']
2802,32041605,Cost-effectiveness of child caries management: a randomised controlled trial (FiCTION trial).,"BACKGROUND


A three-arm parallel group, randomised controlled trial set in general dental practices in England, Scotland, and Wales was undertaken to evaluate three strategies to manage dental caries in primary teeth. Children, with at least one primary molar with caries into dentine, were randomised to receive Conventional with best practice prevention (C + P), Biological with best practice prevention (B + P), or best practice Prevention Alone (PA).
METHODS


Data on costs were collected via case report forms completed by clinical staff at every visit. The co-primary outcomes were incidence of, and number of episodes of, dental pain and/or infection avoided. The three strategies were ranked in order of mean cost and a more costly strategy was compared with a less costly strategy in terms of incremental cost-effectiveness. Costs and outcomes were discounted at 3.5%.
RESULTS


A total of 1144 children were randomised with data on 1058 children (C + P n = 352, B + P n = 352, PA n = 354) used in the analysis. On average, it costs £230 to manage dental caries in primary teeth over a period of up to 36 months. Managing children in PA was, on average, £19 (97.5% CI: -£18 to £55) less costly than managing those in B + P. In terms of effectiveness, on average, there were fewer incidences of, (- 0.06; 97.5% CI: - 0.14 to 0.02) and fewer episodes of dental pain and/or infection (- 0.14; 97.5% CI: - 0.29 to 0.71) in B + P compared to PA. C + P was unlikely to be considered cost-effective, as it was more costly and less effective than B + P.
CONCLUSIONS


The mean cost of a child avoiding any dental pain and/or infection (incidence) was £330 and the mean cost per episode of dental pain and/or infection avoided was £130. At these thresholds B + P has the highest probability of being considered cost-effective. Over the willingness to pay thresholds considered, the probability of B + P being considered cost-effective never exceeded 75%.
TRIAL REGISTRATION


The trial was prospectively registered with the ISRCTN (reference number ISRCTN77044005) on the 26th January 2009 and East of Scotland Research Ethics Committee provided ethical approved (REC reference: 12/ES/0047).",2020,"On average, it costs £230 to manage dental caries in primary teeth over a period of up to 36 months.","['general dental practices in England, Scotland, and Wales was undertaken to evaluate three strategies to manage dental caries in primary teeth', 'child caries management', 'Children, with at least one primary molar with caries into dentine', '1144 children']","['Conventional with best practice prevention (C\u2009+\u2009P), Biological with best practice prevention (B\u2009+\u2009P), or best practice Prevention Alone (PA']","['incidence of, and number of episodes of, dental pain and/or infection avoided', 'mean cost of a child avoiding any dental pain and/or infection (incidence', 'episodes of dental pain and/or infection', 'Costs and outcomes', 'Cost-effectiveness']","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0011334', 'cui_str': 'Dental Decay'}, {'cui': 'C3266841', 'cui_str': 'Baby Teeth'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",1144.0,0.15415,"On average, it costs £230 to manage dental caries in primary teeth over a period of up to 36 months.","[{'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Homer', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, NE2 4AX, UK. tara.homer@newcastle.ac.uk.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Maguire', 'Affiliation': 'School of Dental Sciences, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Gail V A', 'Initials': 'GVA', 'LastName': 'Douglas', 'Affiliation': 'Dental School, University of Leeds, Leeds, UK.'}, {'ForeName': 'Nicola P', 'Initials': 'NP', 'LastName': 'Innes', 'Affiliation': 'School of Dentistry, University of Dundee, Dundee, UK.'}, {'ForeName': 'Jan E', 'Initials': 'JE', 'LastName': 'Clarkson', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Wilson', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, NE2 4AX, UK.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Ryan', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, NE2 4AX, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'McColl', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, NE2 4AX, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Robertson', 'Affiliation': 'School of Dentistry, University of Dundee, Dundee, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Vale', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, NE2 4AX, UK.'}]",BMC oral health,['10.1186/s12903-020-1020-1']
2803,32044943,"Effect of Vancomycin or Daptomycin With vs Without an Antistaphylococcal β-Lactam on Mortality, Bacteremia, Relapse, or Treatment Failure in Patients With MRSA Bacteremia: A Randomized Clinical Trial.","Importance


Methicillin-resistant Staphylococcus aureus (MRSA) bacteremia is associated with mortality of more than 20%. Combining standard therapy with a β-lactam antibiotic has been associated with reduced mortality, although adequately powered randomized clinical trials of this intervention have not been conducted.
Objective


To determine whether combining an antistaphylococcal β-lactam with standard therapy is more effective than standard therapy alone in patients with MRSA bacteremia.
Design, Setting, and Participants


Open-label, randomized clinical trial conducted at 27 hospital sites in 4 countries from August 2015 to July 2018 among 352 hospitalized adults with MRSA bacteremia. Follow-up was complete on October 23, 2018.
Interventions


Participants were randomized to standard therapy (intravenous vancomycin or daptomycin) plus an antistaphylococcal β-lactam (intravenous flucloxacillin, cloxacillin, or cefazolin) (n = 174) or standard therapy alone (n = 178). Total duration of therapy was determined by treating clinicians and the β-lactam was administered for 7 days.
Main Outcomes and Measures


The primary end point was a 90-day composite of mortality, persistent bacteremia at day 5, microbiological relapse, and microbiological treatment failure. Secondary outcomes included mortality at days 14, 42, and 90; persistent bacteremia at days 2 and 5; acute kidney injury (AKI); microbiological relapse; microbiological treatment failure; and duration of intravenous antibiotics.
Results


The data and safety monitoring board recommended early termination of the study prior to enrollment of 440 patients because of safety. Among 352 patients randomized (mean age, 62.2 [SD, 17.7] years; 121 women [34.4%]), 345 (98%) completed the trial. The primary end point was met by 59 (35%) with combination therapy and 68 (39%) with standard therapy (absolute difference, -4.2%; 95% CI, -14.3% to 6.0%). Seven of 9 prespecified secondary end points showed no significant difference. For the combination therapy vs standard therapy groups, all-cause 90-day mortality occurred in 35 (21%) vs 28 (16%) (difference, 4.5%; 95% CI, -3.7% to 12.7%); persistent bacteremia at day 5 was observed in 19 of 166 (11%) vs 35 of 172 (20%) (difference, -8.9%; 95% CI, -16.6% to -1.2%); and, excluding patients receiving dialysis at baseline, AKI occurred in 34 of 145 (23%) vs 9 of 145 (6%) (difference, 17.2%; 95% CI, 9.3%-25.2%).
Conclusions and Relevance


Among patients with MRSA bacteremia, addition of an antistaphylococcal β-lactam to standard antibiotic therapy with vancomycin or daptomycin did not result in significant improvement in the primary composite end point of mortality, persistent bacteremia, relapse, or treatment failure. Early trial termination for safety concerns and the possibility that the study was underpowered to detect clinically important differences in favor of the intervention should be considered when interpreting the findings.
Trial Registration


ClinicalTrials.gov Identifier: NCT02365493.",2020,Seven of 9 prespecified secondary end points showed no significant difference.,"['Patients With MRSA Bacteremia', 'patients with MRSA bacteremia', '27 hospital sites in 4 countries from August 2015 to July 2018 among 352 hospitalized adults with MRSA bacteremia', '440 patients because of safety', '352 patients randomized (mean age, 62.2 [SD, 17.7] years; 121 women [34.4%]), 345 (98%) completed the trial']","['standard therapy (intravenous vancomycin or daptomycin) plus an antistaphylococcal β-lactam (intravenous flucloxacillin, cloxacillin, or cefazolin) (n\u2009=\u2009174) or standard therapy alone', 'antistaphylococcal β-lactam with standard therapy', 'Vancomycin or Daptomycin', 'vancomycin or daptomycin']","['mortality, persistent bacteremia, relapse, or treatment failure', 'persistent bacteremia', 'mortality at days 14, 42, and 90; persistent bacteremia at days 2 and 5; acute kidney injury (AKI); microbiological relapse; microbiological treatment failure; and duration of intravenous antibiotics', 'Total duration of therapy', '90-day composite of mortality, persistent bacteremia at day 5, microbiological relapse, and microbiological treatment failure', '90-day mortality', 'Mortality, Bacteremia, Relapse, or Treatment Failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4040349', 'cui_str': 'Bacteremia caused by Methicillin resistant Staphylococcus aureus (disorder)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517777', 'cui_str': '440 (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517598', 'cui_str': '17.7'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0057144', 'cui_str': 'Daptomycin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0022914', 'cui_str': 'Lactams'}, {'cui': 'C0016267', 'cui_str': 'flucloxacillin'}, {'cui': 'C0009077', 'cui_str': 'Cloxacillin'}, {'cui': 'C0007546', 'cui_str': 'Cefazolin'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0162643'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444917', 'cui_str': 'Duration of therapy (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",352.0,0.317516,Seven of 9 prespecified secondary end points showed no significant difference.,"[{'ForeName': 'Steven Y C', 'Initials': 'SYC', 'LastName': 'Tong', 'Affiliation': 'Victorian Infectious Disease Service, Royal Melbourne Hospital, and University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Lye', 'Affiliation': 'National Centre for Infectious Diseases, Singapore.'}, {'ForeName': 'Dafna', 'Initials': 'D', 'LastName': 'Yahav', 'Affiliation': 'Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel.'}, {'ForeName': 'Archana', 'Initials': 'A', 'LastName': 'Sud', 'Affiliation': 'Nepean Clinical School, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'J Owen', 'Initials': 'JO', 'LastName': 'Robinson', 'Affiliation': 'Royal Perth Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Nelson', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Casuarina, Northern Territory, Australia.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Archuleta', 'Affiliation': 'Division of Infectious Diseases, National University Hospital, Singapore.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Roberts', 'Affiliation': 'Australasian Kidney Trials Network, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Cass', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Casuarina, Northern Territory, Australia.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Paterson', 'Affiliation': 'Centre for Clinical Research, University of Queensland, Herston, Australia.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Foo', 'Affiliation': 'Department of Microbiology and Infectious Diseases, NSW Health Pathology, Liverpool, New South Wales, Australia.'}, {'ForeName': 'Mical', 'Initials': 'M', 'LastName': 'Paul', 'Affiliation': 'Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Guy', 'Affiliation': 'Footscray Hospital, Western Health, Footscray, Victoria, Australia.'}, {'ForeName': 'Adrian R', 'Initials': 'AR', 'LastName': 'Tramontana', 'Affiliation': 'Footscray Hospital, Western Health, Footscray, Victoria, Australia.'}, {'ForeName': 'Genevieve B', 'Initials': 'GB', 'LastName': 'Walls', 'Affiliation': 'Department of Infectious Diseases, Middlemore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'McBride', 'Affiliation': 'Department of Infectious Diseases, Middlemore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Narin', 'Initials': 'N', 'LastName': 'Bak', 'Affiliation': 'Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Niladri', 'Initials': 'N', 'LastName': 'Ghosh', 'Affiliation': 'Wollongong Public Hospital, Wollongong, New South Wales, Australia.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Rogers', 'Affiliation': 'School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Anna P', 'Initials': 'AP', 'LastName': 'Ralph', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Casuarina, Northern Territory, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Davies', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Casuarina, Northern Territory, Australia.'}, {'ForeName': 'Patricia E', 'Initials': 'PE', 'LastName': 'Ferguson', 'Affiliation': 'Department of Infectious Diseases, Blacktown Hospital, Blacktown, New South Wales, Australia.'}, {'ForeName': 'Ravindra', 'Initials': 'R', 'LastName': 'Dotel', 'Affiliation': 'Department of Infectious Diseases, Blacktown Hospital, Blacktown, New South Wales, Australia.'}, {'ForeName': 'Genevieve L', 'Initials': 'GL', 'LastName': 'McKew', 'Affiliation': 'Department of Microbiology and Infectious Diseases, Concord Repatriation General Hospital, Concord, New South Wales, Australia.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Gray', 'Affiliation': 'Department of Microbiology and Infectious Diseases, Concord Repatriation General Hospital, Concord, New South Wales, Australia.'}, {'ForeName': 'Natasha E', 'Initials': 'NE', 'LastName': 'Holmes', 'Affiliation': 'Department of Infectious Diseases, Austin Health, Austin Centre for Infection Research, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Cairns Hospital, Cairns, Queensland, Australia.'}, {'ForeName': 'Morgyn S', 'Initials': 'MS', 'LastName': 'Warner', 'Affiliation': 'The Queen Elizabeth Hospital, Woodville, South Australia, Australia.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Kalimuddin', 'Affiliation': 'Department of Infectious Diseases, Singapore General Hospital, Singapore.'}, {'ForeName': 'Barnaby E', 'Initials': 'BE', 'LastName': 'Young', 'Affiliation': 'National Centre for Infectious Diseases, Singapore.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Runnegar', 'Affiliation': 'Infection Management Services, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Andresen', 'Affiliation': ""St Vincent's Public Hospital Sydney, Darlinghurst, New South Wales, Australia.""}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Anagnostou', 'Affiliation': 'Flinders Medical Centre, Adelaide, South Australia, Australia.'}, {'ForeName': 'Sandra A', 'Initials': 'SA', 'LastName': 'Johnson', 'Affiliation': 'Victorian Infectious Disease Service, Royal Melbourne Hospital, and University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Chatfield', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Casuarina, Northern Territory, Australia.'}, {'ForeName': 'Allen C', 'Initials': 'AC', 'LastName': 'Cheng', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Vance G', 'Initials': 'VG', 'LastName': 'Fowler', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Howden', 'Affiliation': 'Department of Infectious Diseases, Austin Health, Austin Centre for Infection Research, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Niamh', 'Initials': 'N', 'LastName': 'Meagher', 'Affiliation': 'Victorian Infectious Diseases Reference Laboratory Epidemiology Unit, Royal Melbourne Hospital, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Price', 'Affiliation': 'Victorian Infectious Diseases Reference Laboratory Epidemiology Unit, Royal Melbourne Hospital, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sebastiaan J', 'Initials': 'SJ', 'LastName': 'van Hal', 'Affiliation': 'Department of Microbiology and Infectious Disease, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Matthew V N', 'Initials': 'MVN', 'LastName': ""O'Sullivan"", 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Joshua S', 'Initials': 'JS', 'LastName': 'Davis', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Casuarina, Northern Territory, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.0103']
2804,31922462,Long-Term Safety and Curvature Deformity Characterization in Patients Previously Treated with Collagenase clostridium Histolyticum for Peyronie's Disease.,"PURPOSE


We assessed the long-term safety and immunogenicity profile of collagenase clostridium histolyticum and characterized penile curvature deformity over time in patients previously treated for Peyronie's disease.
MATERIALS AND METHODS


This phase 4 study included men who received collagenase clostridium histolyticum in either 12-month, double-blind, placebo controlled clinical trials (IMPRESS I/II), or one of two 9-month open label studies. Eligible patients received no additional collagenase clostridium histolyticum treatment and were followed once yearly for up to 5 years to assess Peyronie's disease clinical symptoms, patient reported outcomes and safety.
RESULTS


Of 280 patients enrolled 204 (73%) completed the study. At baseline 247 patients had already experienced a mean±SD penile curvature decrease from 51.8±15.0 to 31.0±16.1 degrees (improvement of 20.9±16.2 degrees or 39.5%). At year 5 in 180 patients, despite no additional treatment, there was an additional 9.1% improvement in mean penile curvature compared with reference data (4.3±13.4 degrees, 95% CI 2.3-6.2, p <0.02). At baseline 183 patients experienced mean Peyronie's Disease Questionnaire bother domain score improvement from 6.5±3.5 to 3.4±3.3. At year 5 there was additional score improvement to 2.4±2.9 (p=0.0003). Adverse events were reported in 17.5% (49) of patients but no adverse events were considered treatment related. No long-term safety issues were identified up to 5 years after treatment. Long-term immunogenicity profiling showed a decreasing trend in the number of anti-AUX-I and anti-AUX-II seropositive cases at years 4 and 5 after collagenase clostridium histolyticum treatment.
CONCLUSIONS


Most patients treated with collagenase clostridium histolyticum continued to have penile curvature and Peyronie's Disease Questionnaire domain score improvements through year 5 without additional collagenase clostridium histolyticum treatment, and no additional safety signals were identified.",2020,"At Year 5, there was additional score improvement to 2.4±2.9 (p=0.0003).","['Patients', ""patients previously treated for Peyronie's disease (PD"", '280 patients enrolled, 204 (73%) completed the study']","['no additional CCH', 'collagenase clostridium histolyticum (CCH', 'CCH', 'placebo', 'Collagenase Clostridium Histolyticum']","['mean penile curvature decrease', ""mean Peyronie's Disease Questionnaire (PDQ) bother domain score improvement"", 'penile curvature and PDQ domain score improvements', 'mean penile curvature', 'Adverse events (AEs', 'number of anti-AUX-I and anti-AUX']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0030848', 'cui_str': 'Peyronie Disease'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0009053', 'cui_str': 'collagenase Clostridium histolyticum'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2938970', 'cui_str': 'Penile curvature'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0030848', 'cui_str': 'Peyronie Disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",280.0,0.0978339,"At Year 5, there was additional score improvement to 2.4±2.9 (p=0.0003).","[{'ForeName': 'Irwin', 'Initials': 'I', 'LastName': 'Goldstein', 'Affiliation': 'Alvarado Hospital, San Diego, California.'}, {'ForeName': 'Larry I', 'Initials': 'LI', 'LastName': 'Lipshultz', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McLane', 'Affiliation': 'Endo Pharmaceuticals Inc., Malvern, Pennsylvania.'}, {'ForeName': 'Yiqun', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Endo Pharmaceuticals Inc., Malvern, Pennsylvania.'}, {'ForeName': 'Qinfang', 'Initials': 'Q', 'LastName': 'Xiang', 'Affiliation': 'Endo Pharmaceuticals Inc., Malvern, Pennsylvania.'}, {'ForeName': 'Genzhou', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Endo Pharmaceuticals Inc., Malvern, Pennsylvania.'}, {'ForeName': 'Saji', 'Initials': 'S', 'LastName': 'Vijayan', 'Affiliation': 'Endo Pharmaceuticals Inc., Malvern, Pennsylvania.'}, {'ForeName': 'Martin K', 'Initials': 'MK', 'LastName': 'Gelbard', 'Affiliation': 'Urology Associates Medical Group, Burbank, California.'}]",The Journal of urology,['10.1097/JU.0000000000000743']
2805,32109425,"Gefapixant, a P2X3 receptor antagonist, for the treatment of refractory or unexplained chronic cough: a randomised, double-blind, controlled, parallel-group, phase 2b trial.","BACKGROUND


Gefapixant is a P2X3 receptor antagonist that has shown promise for the treatment of refractory and unexplained chronic cough. The aim of this study was to evaluate the efficacy of gefapixant compared with placebo after 12 weeks of treatment for refractory chronic cough or unexplained chronic cough.
METHODS


We did a 12-week, phase 2b, randomised, double-blind, placebo-controlled study in patients with refractory chronic cough or unexplained chronic cough aged 18-80 years who were recruited from 44 primarily outpatient pulmonologist or allergist sites in the UK and the USA. Eligible patients had refractory or unexplained chronic cough lasting 1 year or longer, no radiographic chest abnormality, and 40 mm or more on a 100-mm cough severity visual analogue scale at enrolment. Patients were randomly assigned to receive placebo or one of three doses (7·5 mg, 20 mg, or 50 mg) of oral gefapixant twice daily, every day, for 84 days; visits to investigative sites were on days 1, 28, 42, 56, 70, 84, and 85. The randomisation schedule was computer generated using a permuted block algorithm by Advance Research Associates (Santa Clara, CA, USA). Patients and all personnel involved in the conduct and interpretation of the study were masked to treatment assignment. The primary endpoint was placebo-adjusted change from baseline in awake cough frequency after 12 weeks, assessed in the full analysis set, which is a subset of the intention-to-treat population. Adverse events were monitored and safety was evaluated in all patients receiving one or more doses of study drug. This trial is registered with ClinicalTrials.gov, NCT02612610.
FINDINGS


Between Dec 21, 2015, and July 26, 2016, 253 patients were randomly assigned to placebo (n=63), gefapixant 7·5 mg (n=64), gefapixant 20 mg (n=63), or gefapixant 50 mg (n=63) twice daily. The mean age of patients was 60·2 (SD 9·9) years and 193 (76%) were women. At 12 weeks, patients' geometric mean awake cough frequency was 18·2 coughs per h (geometric SD 3·1) with placebo, and 14·5 coughs per h (3·7) with 7·5 mg, 12·0 coughs per h (4·2) with 20 mg, and 11·3 coughs per h (2·8) with 50 mg gefapixant. Estimated percentage change relative to placebo was -22·0% (-41·8 to 4·6; p=0·097) with 7·5 mg, -22·2% (-42·0 to 4·3; p=0·093) with 20 mg, and -37·0% (95% CI -53·3 to -14·9; p=0·0027) with 50 mg gefapixant. Dysgeusia was the most common adverse event, occurring in three (5%) patients given placebo, six (10%) given 7·5 mg gefapixant, 21 (33%) given 20 mg gefapixant, and 30 (48%) given 50 mg gefapixant.
INTERPRETATION


Targeting purinergic receptor P2X3 with gefapixant at a dose of 50 mg twice daily significantly reduced cough frequency in patients with refractory chronic cough or unexplained chronic cough after 12 weeks of treatment compared with placebo. Further development of gefapixant is warranted for the treatment of chronic cough.
FUNDING


Afferent Pharmaceuticals (acquired by Merck & Co., Inc., Kenilworth, NJ, USA).",2020,"Dysgeusia was the most common adverse event, occurring in three (5%) patients given placebo, six (10%) given 7·5 mg gefapixant, 21 (33%) given 20 mg gefapixant, and 30 (48%) given 50 mg gefapixant.
","['patients with refractory chronic cough or unexplained chronic cough aged 18-80 years who were recruited from 44 primarily outpatient pulmonologist or allergist sites in the UK and the USA', 'SD 9·9) years and 193 (76%) were women', 'patients with refractory chronic cough or unexplained chronic cough after 12 weeks of treatment compared with', 'mean age of patients was 60·2', 'Between Dec 21, 2015, and July 26, 2016, 253 patients', 'Eligible patients had refractory or unexplained chronic cough lasting 1 year or longer, no radiographic chest abnormality, and 40 mm or more on a 100-mm cough severity visual analogue scale at enrolment', 'refractory chronic cough or unexplained chronic cough']","['placebo', 'gefapixant', 'oral gefapixant', 'gefapixant 7·5 mg (n=64), gefapixant 20 mg (n=63), or gefapixant 50 mg']","['placebo-adjusted change from baseline in awake cough frequency', 'geometric mean awake cough frequency', 'cough frequency', 'Adverse events', 'Dysgeusia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4552486', 'cui_str': 'Refractory chronic cough'}, {'cui': 'C4552485', 'cui_str': 'Unexplained chronic cough'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0586859', 'cui_str': 'Pulmonologists'}, {'cui': 'C0334896', 'cui_str': 'Allergists'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0450402', 'cui_str': '40mm (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013378', 'cui_str': 'Taste, Distorted'}]",253.0,0.672719,"Dysgeusia was the most common adverse event, occurring in three (5%) patients given placebo, six (10%) given 7·5 mg gefapixant, 21 (33%) given 20 mg gefapixant, and 30 (48%) given 50 mg gefapixant.
","[{'ForeName': 'Jaclyn A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'Division of Infection, Immunity, and Respiratory Medicine, University of Manchester, Manchester, UK; Manchester University NHS Foundation Trust, Manchester, UK. Electronic address: jacky.smith@manchester.ac.uk.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Kitt', 'Affiliation': 'Merck & Co., Kenilworth, NJ, USA.'}, {'ForeName': 'Alyn H', 'Initials': 'AH', 'LastName': 'Morice', 'Affiliation': 'Hull York Medical School, Cottingham, UK.'}, {'ForeName': 'Surinder S', 'Initials': 'SS', 'LastName': 'Birring', 'Affiliation': ""Centre for Human & Applied Physiological Sciences, School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Lorcan P', 'Initials': 'LP', 'LastName': 'McGarvey', 'Affiliation': ""Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Mandel R', 'Initials': 'MR', 'LastName': 'Sher', 'Affiliation': 'Center for Cough, Largo, FL, USA.'}, {'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Li', 'Affiliation': 'GetStat Solutions, LLC, Palo Alto, CA, USA.'}, {'ForeName': 'Wen-Chi', 'Initials': 'WC', 'LastName': 'Wu', 'Affiliation': 'Merck & Co., Kenilworth, NJ, USA.'}, {'ForeName': 'Zhi Jin', 'Initials': 'ZJ', 'LastName': 'Xu', 'Affiliation': 'Merck & Co., Kenilworth, NJ, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Muccino', 'Affiliation': 'Merck & Co., Kenilworth, NJ, USA.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Ford', 'Affiliation': 'Merck & Co., Kenilworth, NJ, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30471-0']
2806,32168305,Hypothermia Plus Melatonin in Asphyctic Newborns: A Randomized-Controlled Pilot Study.,"OBJECTIVES


To investigate the effect of adding melatonin to hypothermia treatment on neurodevelopmental outcomes in asphyctic newborns.
DESIGN


Pilot multicenter, randomized, controlled, double-blind clinical trial. Statistical comparison of results obtained in two intervention arms: hypothermia plus placebo and hypothermia plus melatonin.
SETTING


Level 3 neonatal ICU.
PATIENTS


Twenty-five newborns were recruited.
INTERVENTIONS


The hypothermia plus melatonin patients received a daily dose of IV melatonin, 5 mg per kg body weight, for 3 days. General laboratory variables were measured both at neonatal ICU admission and after intervention. All infants were studied with amplitude-integrated electroencephalography and brain MRI within the first week of life. The neurodevelopmental Bayley III test, the Gross Motor Function Classification System, and the Tardieu scale were applied at the ages of 6 and 18 months.
MEASUREMENTS AND MAIN RESULTS


Clinical characteristics, laboratory evaluations, MRI findings, and amplitude-integrated electroencephalography background did not differ between the treatment groups. The newborns in the hypothermia plus melatonin group achieved a significantly higher composite score for the cognitive section of the Bayley III test at 18 months old, with respect to the hypothermia plus placebo group (p = 0.05). There were no differences between the groups according to the Gross Motor Function Classification System and Tardieu motor assessment scales.
CONCLUSIONS


The early addition of IV melatonin to asphyctic neonates is feasible and may improve long-term neurodevelopment. To our knowledge, this is the first clinical trial to analyze the administration of IV melatonin as an adjuvant therapy to therapeutic hypothermia.",2020,"The newborns in the hypothermia plus melatonin group achieved a significantly higher composite score for the cognitive section of the Bayley III test at 18 months old, with respect to the hypothermia plus placebo group (p = 0.05).","['Asphyctic Newborns', 'asphyctic newborns', 'Twenty-five newborns were recruited', 'Level 3 neonatal ICU']","['hypothermia plus placebo', 'IV melatonin', 'hypothermia plus melatonin', 'melatonin', 'Hypothermia Plus Melatonin']","['Gross Motor Function Classification System and Tardieu motor assessment scales', 'neurodevelopmental Bayley III test, the Gross Motor Function Classification System, and the Tardieu scale', 'Clinical characteristics, laboratory evaluations, MRI findings, and amplitude-integrated electroencephalography background', 'composite score', 'neurodevelopmental outcomes']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0456949', 'cui_str': 'Level 3 (qualifier value)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}]","[{'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}]","[{'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0451321', 'cui_str': 'Motor assessment scale (assessment scale)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",25.0,0.157979,"The newborns in the hypothermia plus melatonin group achieved a significantly higher composite score for the cognitive section of the Bayley III test at 18 months old, with respect to the hypothermia plus placebo group (p = 0.05).","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Jerez-Calero', 'Affiliation': 'All authors: Department of Paediatrics, San Cecilio University Hospital, Granada, Spain.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Salvatierra-Cuenca', 'Affiliation': ''}, {'ForeName': 'Ángela', 'Initials': 'Á', 'LastName': 'Benitez-Feliponi', 'Affiliation': ''}, {'ForeName': 'Carmen Elisabeth', 'Initials': 'CE', 'LastName': 'Fernández-Marín', 'Affiliation': ''}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Narbona-López', 'Affiliation': ''}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Uberos-Fernández', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Muñoz-Hoyos', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002346']
2807,32083693,Development and Validation of a Machine Learning Individualized Treatment Rule in First-Episode Schizophrenia.,"Importance


Little guidance exists to date on how to select antipsychotic medications for patients with first-episode schizophrenia.
Objective


To develop a preliminary individualized treatment rule (ITR) for patients with first-episode schizophrenia.
Design, Setting, and Participants


This prognostic study obtained data from Taiwan's National Health Insurance Research Database on patients with prescribed antipsychotic medications, ambulatory claims, or discharge diagnoses of a schizophrenic disorder between January 1, 2005, and December 31, 2011. An ITR was developed by applying a targeted minimum loss-based ensemble machine learning method to predict treatment success from baseline clinical and demographic data in a 70% training sample. The model was validated in the remaining 30% of the sample. The probability of treatment success was estimated for each medication for each patient under the model. The analysis was conducted between July 16, 2018, and July 15, 2019.
Exposures


Fifteen different antipsychotic medications.
Main Outcomes and Measures


Treatment success was defined as not switching medication and not being hospitalized for 12 months.
Results


Among the 32 277 patients in the analysis, the mean (SD) age was 36.7 (14.3) years, and 15 752 (48.8%) were male. In the validation sample, the treatment success rate (SE) was 51.7% (1.0%) under the ITR and was 44.5% (0.5%) in the observed population (Z = 7.1; P < .001). The estimated treatment success if all patients were given a prescription for 1 medication was significantly lower for each of the 13 medications than under the ITR (Z = 4.2-16.8; all P < .001). Aripiprazole (3088 [31.9%]) and amisulpride (2920 [30.2%]) were the medications most often recommended by the ITR. Only 1054 patients (10.9%) received ITR-recommended medications. Observed treatment success, although lower than the success under the ITR, was nonetheless significantly higher than if medications had been randomized (44.5% [SE, 0.55%] vs 41.3% [SE, 0.4%]; Z = 6.9; P < .001), although only marginally higher than if medications had been randomized in their observed population proportions (44.5% [SE, 0.5%] vs 43.5% [SE, 0.4%]; Z = 2.2; P = .03]).
Conclusions and Relevance


These results suggest that an ITR may be associatded with an increase in the treatment success rate among patients with first-episode schizophrenia, but experimental evaluation is needed to confirm this possibility. If confirmed, model refinement that investigates biomarkers, clinical observations, and patient reports as additional predictors in iterative pragmatic trials would be needed before clinical implementation.",2020,The estimated treatment success if all patients were given a prescription for 1 medication was significantly lower for each of the 13 medications than under the ITR (Z = 4.2-16.8; all P < .001).,"['Exposures\n\n\nFifteen different antipsychotic medications', 'July 16, 2018, and July 15, 2019', 'patients with first-episode schizophrenia', 'Among the 32\u202f277 patients in the analysis, the mean (SD) age was 36.7 (14.3) years, and 15 752 (48.8%) were male', 'First-Episode Schizophrenia', 'patients with prescribed antipsychotic medications, ambulatory claims, or discharge diagnoses of a schizophrenic disorder between January 1, 2005, and December 31, 2011']","['Aripiprazole', 'amisulpride']","['treatment success rate (SE', 'probability of treatment success']","[{'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0103045', 'cui_str': 'Amisulpride'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",32277.0,0.024835,The estimated treatment success if all patients were given a prescription for 1 medication was significantly lower for each of the 13 medications than under the ITR (Z = 4.2-16.8; all P < .001).,"[{'ForeName': 'Chi-Shin', 'Initials': 'CS', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry, National Taiwan University Hospital & College of Medicine, National Taiwan University, Taipei City, Taiwan.'}, {'ForeName': 'Alex R', 'Initials': 'AR', 'LastName': 'Luedtke', 'Affiliation': 'Department of Statistics, University of Washington, Seattle.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Sadikova', 'Affiliation': 'Department of Health Care Policy, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Hui-Ju', 'Initials': 'HJ', 'LastName': 'Tsai', 'Affiliation': 'Institute of Population Health Sciences, National Health Research Institutes, Zhunan, Taiwan.'}, {'ForeName': 'Shih-Cheng', 'Initials': 'SC', 'LastName': 'Liao', 'Affiliation': 'Department of Psychiatry, National Taiwan University Hospital & College of Medicine, National Taiwan University, Taipei City, Taiwan.'}, {'ForeName': 'Chen-Chung', 'Initials': 'CC', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, National Taiwan University Hospital & College of Medicine, National Taiwan University, Taipei City, Taiwan.'}, {'ForeName': 'Susan Shur-Fen', 'Initials': 'SS', 'LastName': 'Gau', 'Affiliation': 'Department of Psychiatry, National Taiwan University Hospital & College of Medicine, National Taiwan University, Taipei City, Taiwan.'}, {'ForeName': 'Tyler J', 'Initials': 'TJ', 'LastName': 'VanderWeele', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Ronald C', 'Initials': 'RC', 'LastName': 'Kessler', 'Affiliation': 'Department of Health Care Policy, Harvard Medical School, Boston, Massachusetts.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.21660']
2808,31676301,Stimulating the ventrolateral prefrontal cortex (VLPFC) modulates frustration-induced aggression: A tDCS experiment.,"BACKGROUND


The prefrontal cortex is crucial for top-down regulation of aggression, but the neural underpinnings of aggression are still poorly understood. Past research showed the transcranial direct current stimulation (tDCS) over the ventrolateral prefrontal cortex (VLPFC) modulates aggression following exposure to risk factors for aggression (e.g., social exclusion, violent media). Although frustration is a key risk factor for aggression, no study to date has examined the modulatory role of tDCS on frustration-induced aggression.
OBJECTIVES


By exploring the VLPFC involvement in frustration-aggression link, we tested the hypothesis that the anodal tDCS over right and left VLPFC modulates frustration-induced aggression. We also explored whether tDCS interacts with gender to influence frustration-induced aggression.
METHODS


90 healthy participants (45 men) were randomly assigned to receive anodal or sham tDCS over the right or left VLPFC before being frustrated by an accomplice. To increase reliability, several tasks were used to measure aggression.
RESULTS


We found that anodal tDCS over the left VLPFC, compared to sham stimulation, increased aggression. Unexpectedly, no main effect was found following tDCS of right VLPFC. However, we also found a significant interaction between gender and tDCS, showing that males were more aggressive than females following sham stimulation, but females became as aggressive as males following active tDCS.
CONCLUSION


Overall, these results shed light on the neural basis of frustration-induced aggression, providing further evidence for the involvement of VLPFC in modulating aggressive responses, and on gender differences in aggression. Future research should further investigate the role of stimulating the VLPFC on frustration-induced aggression.",2020,"Unexpectedly, no main effect was found following tDCS of right VLPFC.",['90 healthy participants (45 men'],"['transcranial direct current stimulation (tDCS', 'anodal tDCS', 'anodal or sham tDCS', 'tDCS']",['aggression'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0001807', 'cui_str': 'Aggression'}]",90.0,0.0282102,"Unexpectedly, no main effect was found following tDCS of right VLPFC.","[{'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Gallucci', 'Affiliation': 'University of Milano-Bicocca, Milan, Italy. Electronic address: a.gallucci@campus.unimib.it.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Riva', 'Affiliation': 'University of Milano-Bicocca, Milan, Italy. Electronic address: paolo.riva1@unimib.it.'}, {'ForeName': 'Leonor J', 'Initials': 'LJ', 'LastName': 'Romero Lauro', 'Affiliation': 'University of Milano-Bicocca, Milan, Italy. Electronic address: l.romerolauro@gmail.com.'}, {'ForeName': 'Brad J', 'Initials': 'BJ', 'LastName': 'Bushman', 'Affiliation': 'The Ohio State University, Columbus, OH, USA. Electronic address: bushman.20@osu.edu.'}]",Brain stimulation,['10.1016/j.brs.2019.10.015']
2809,31734419,Effect of Sevoflurane Postconditioning on the Incidence of Symptomatic Cerebral Hyperperfusion After Revascularization Surgery in Adult Patients with Moyamoya Disease.,"OBJECTIVE


Various experimental studies have reported neuroprotective effects of sevoflurane postconditioning against cerebral ischemia-reperfusion injury. We therefore investigated its neuroprotective effects on hyperperfusion-related transient neurologic deterioration, called symptomatic cerebral hyperperfusion (SCH), and also identified predictive factors for SCH in patients with moyamoya disease after revascularization surgery.
METHODS


A total of 152 adult patients with moyamoya disease undergoing anastomosis of the superficial temporal artery to middle cerebral artery were randomly allocated into 2 groups. The postconditioning group (group S, n = 76) inhaled sevoflurane of 1 minimum alveolar concentration for 15 minutes immediately after reperfusion and then washed it out slowly for 15 minutes. The control group (group C, n = 76) received no intervention. The incidence of SCH was compared between the 2 groups.
RESULTS


The incidence of SCH was not significantly different between groups S and C (53.3% vs. 43.4%, respectively; P = 0.291). The incidence of postoperative complications and the Glasgow Outcome Scale score at hospital discharge also did not differ significantly. Predictive factors for SCH included a decreased vascular reserve in preoperative single-photon emission computed tomography scan (odds ratio [OR], 7.18; 95% confidence interval [CI], 1.78-29.02; P = 0.006), an operation performed on the dominant hemisphere (OR, 3.32; 95% CI, 1.57-6.98; P = 0.002), temporal occlusion time (OR, 1.06; 95% CI, 1.01-1.11; P = 0.017), and intraoperative minimum partial pressure of carbon dioxide (P a CO 2 ) (OR, 0.86; 95% CI, 0.78-0.94; P = 0.001).
CONCLUSIONS


Sevoflurane postconditioning did not reduce the incidence of SCH after revascularization surgery in patients with moyamoya disease. Rather, a decreased vascular reserve, operation on the dominant hemisphere, increased temporal occlusion time, and decreased intraoperative minimum P a CO 2  were associated with SCH in these patients.",2020,The incidence of SCH was not significantly different between groups S and C (53.3 vs 43.4%; P=0.291).,"['152 adult moyamoya patients undergoing anastomosis of superficial temporal artery to middle cerebral artery', 'Adult Patients with Moyamoya Disease', 'moyamoya patients', 'moyamoya patients after revascularization surgery']","['Sevoflurane postconditioning', 'sevoflurane postconditioning', 'no intervention', 'sevoflurane', 'Sevoflurane Postconditioning']","['vascular reserve, operation on the dominant hemisphere, increased temporal occlusion time', 'temporal occlusion time', 'vascular reserve', 'incidence of postoperative complications and the Glasgow Outcome Scale at hospital discharge', 'Symptomatic Cerebral Hyperperfusion', 'intraoperative minimum partial pressure of carbon dioxide', 'incidence of SCH']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0226130', 'cui_str': 'Structure of superficial temporal artery'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}, {'cui': 'C0026654', 'cui_str': 'Cerebrovascular Moyamoya Disease'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0701887', 'cui_str': 'Glasgow Outcome Scale'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}]",152.0,0.126328,The incidence of SCH was not significantly different between groups S and C (53.3 vs 43.4%; P=0.291).,"[{'ForeName': 'Hyun-Kyu', 'Initials': 'HK', 'LastName': 'Yoon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyongmin', 'Initials': 'H', 'LastName': 'Oh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyung-Chul', 'Initials': 'HC', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Won-Sang', 'Initials': 'WS', 'LastName': 'Cho', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jeong Eun', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jae Won', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': ""Department of Neurosurgery, Bucheon St. Mary's Hospital, The Catholic University of Korea, Bucheon, Korea.""}, {'ForeName': 'Hongyoon', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': 'Department of Nuclear Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hee-Pyoung', 'Initials': 'HP', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea. Electronic address: hppark@snu.ac.kr.'}]",World neurosurgery,['10.1016/j.wneu.2019.11.055']
2810,31097294,Striatal Dopamine Release in Response to Morphine: A [ 11 C]Raclopride Positron Emission Tomography Study in Healthy Men.,"BACKGROUND


Preclinical and human positron emission tomography studies have produced inconsistent results regarding the effects of opioids on mesolimbic dopamine (DA). Here, we quantify striatal DA release (measured by [ 11 C]raclopride displacement) in response to an intravenous infusion of morphine, and its relationship with morphine-induced subjective effects, in healthy, nondependent opioid-experienced participants.
METHODS


Fifteen healthy male participants were initially included. Sessions were on separate days. On session 1, participants received intravenous morphine (10 mg/70 kg) in the clinic to ensure tolerability. Participants without adverse reactions (n = 10) then received intravenous morphine and placebo (saline) sessions, in counterbalanced order, while undergoing [ 11 C]raclopride positron emission tomography scans. Subjective and physiological responses were assessed. Region-of-interest and voxelwise image analyses were used to assess changes in [ 11 C]raclopride nondisplaceable binding potential.
RESULTS


Morphine produced marked subjective and physiological effects and induced a significant decrease in [ 11 C]raclopride nondisplaceable binding potential, particularly in the nucleus accumbens and globus pallidus, where the change in [ 11 C]raclopride nondisplaceable binding potential was approximately 9%. However, the subjective effects of morphine did not show a simple pattern of correlation with DA release.
CONCLUSIONS


This is, to our knowledge, the first study providing in vivo human evidence that DA transmission in the ventral striatum is affected by morphine. Further studies are required to fully delineate the DA contribution to the reinforcing effects of opioids.",2019,"RESULTS


Morphine produced marked subjective and physiological effects and induced a significant decrease in [ 11 C]-raclopride nondisplaceable binding potential, particularly in the nucleus accumbens and globus pallidus, where the change in [ 11 C]-raclopride nondisplaceable binding potential was approximately 9%.","['Fifteen healthy male participants were initially included', 'Participants without adverse reactions (n\xa0= 10) then received', 'healthy, nondependent opioid-experienced participants', 'Healthy Men']","['Morphine', 'intravenous morphine', 'morphine', 'intravenous morphine and placebo (saline) sessions', 'C]-Raclopride']","['striatal DA release', 'Subjective and physiological responses', 'marked subjective and physiological effects']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0072953', 'cui_str': 'Raclopride'}]","[{'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",15.0,0.0378044,"RESULTS


Morphine produced marked subjective and physiological effects and induced a significant decrease in [ 11 C]-raclopride nondisplaceable binding potential, particularly in the nucleus accumbens and globus pallidus, where the change in [ 11 C]-raclopride nondisplaceable binding potential was approximately 9%.","[{'ForeName': 'Primavera A', 'Initials': 'PA', 'LastName': 'Spagnolo', 'Affiliation': 'Human Motor Control Section, National Institute on Neurological Disorders and Stroke, National Instutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Alane', 'Initials': 'A', 'LastName': 'Kimes', 'Affiliation': 'Intramural Research Program, National Institute on Drug Abuse, National Institutes of Health, Baltimore, Maryland.'}, {'ForeName': 'Melanie L', 'Initials': 'ML', 'LastName': 'Schwandt', 'Affiliation': 'Office of the Clinical Director, National Institute on Alcohol Abuse and Alcoholism, National Instutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Shokri-Kojori', 'Affiliation': 'Laboratory of Neuroimaging, National Institute on Alcohol Abuse and Alcoholism, National Instutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Shantalaxmi', 'Initials': 'S', 'LastName': 'Thada', 'Affiliation': 'Positron Emission Tomography Department, Clinical Center, National Institute on Drug Abuse, National Institutes of Health, Baltimore, Maryland.'}, {'ForeName': 'Karran A', 'Initials': 'KA', 'LastName': 'Phillips', 'Affiliation': 'Intramural Research Program, National Institute on Drug Abuse, National Institutes of Health, Baltimore, Maryland.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Diazgranados', 'Affiliation': 'Office of the Clinical Director, National Institute on Alcohol Abuse and Alcoholism, National Instutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Kenzie L', 'Initials': 'KL', 'LastName': 'Preston', 'Affiliation': 'Intramural Research Program, National Institute on Drug Abuse, National Institutes of Health, Baltimore, Maryland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Herscovitch', 'Affiliation': 'Positron Emission Tomography Department, Clinical Center, National Institute on Drug Abuse, National Institutes of Health, Baltimore, Maryland.'}, {'ForeName': 'Dardo', 'Initials': 'D', 'LastName': 'Tomasi', 'Affiliation': 'Laboratory of Neuroimaging, National Institute on Alcohol Abuse and Alcoholism, National Instutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Vijay A', 'Initials': 'VA', 'LastName': 'Ramchandani', 'Affiliation': 'Section on Human Psychopharmacology, National Institute on Alcohol Abuse and Alcoholism, National Instutes of Health, Bethesda, Maryland. Electronic address: vijayr@mail.nih.gov.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heilig', 'Affiliation': 'Center for Social and Affective Neuroscience, Linköping University, Linköping, Sweden. Electronic address: markus.heilig@liu.se.'}]",Biological psychiatry,['10.1016/j.biopsych.2019.03.965']
2811,31885908,The Impact of Step Recommendations on Body Composition and Physical Activity Patterns in College Freshman Women: A Randomized Trial.,"Purpose


Transitioning from high school to college generally results in reduced physical activity and weight gain at a rate that is higher than the general population. The purpose of this study was to examine the effects of three progressively higher step recommendations over 24 weeks on changes in body weight and body composition.
Methods


Ninety-two freshmen college women wore a multifunction pedometer for 24 weeks after being randomly assigned to a daily step level: 10,000, 12,500, or 15,000. Pedometer data were downloaded every two weeks and participants were counseled on meeting their step recommendation. Body weight and body composition were assessed at baseline and 24 weeks. Body composition was assessed by dual X-ray absorptiometry.
Results


On average, women took 10,786 ± 1501, 12,650 ± 2001, and 13,762 ± 2098 steps per day for the 10,000-, 12,500-, and 15,000-step groups, respectively ( F  = 15.48,  P  < 0.0001). Participants gained 1.4 ± 2.6, 1.8 ± 2.1, and 1.4 ± 2.1 kg for the 10,000-, 12,500-, and 15,000-step groups, respectively ( F  = 37.74,  P  < 0.0001). Weight gain was not significantly different between groups ( F  = 0.18,  P =0.8385). There was also no difference in fat weight gain ( F  = 0.41,  P =0.7954).
Discussion


A step recommendation beyond 10,000 does not prevent weight or fat gain over the first year of college. Future research should focus on either intensity of physical activity or the addition of dietary interventions to prevent weight gain during the first year of college.",2019,"There was also no difference in fat weight gain ( F  = 0.41,  P =0.7954).
","['Methods\n\n\nNinety-two freshmen college women wore a', 'College Freshman Women']",['multifunction pedometer'],"['Body composition', 'Body weight and body composition', 'weight or fat gain', 'physical activity and weight gain', 'Weight gain', 'body weight and body composition', 'Body Composition and Physical Activity Patterns', 'fat weight gain', 'weight gain']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",2098.0,0.0631198,"There was also no difference in fat weight gain ( F  = 0.41,  P =0.7954).
","[{'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Bailey', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Ciera L', 'Initials': 'CL', 'LastName': 'Bartholomew', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Caleb', 'Initials': 'C', 'LastName': 'Summerhays', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Deru', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Sharla', 'Initials': 'S', 'LastName': 'Compton', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Larry A', 'Initials': 'LA', 'LastName': 'Tucker', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'LeCheminant', 'Affiliation': 'Department of Nutrition, Dietetics & Food Science, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Hicks', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT, USA.'}]",Journal of obesity,['10.1155/2019/4036825']
2812,31545577,Impact of Lung Expansion Therapy Using Positive End-Expiratory Pressure in Mechanically Ventilated Patients Submitted to Coronary Artery Bypass Grafting.,"OBJECTIVE


To evaluate the impact of different levels of positive end-expiratory pressure (PEEP) on gas exchange in patients undergoing coronary artery bypass grafting (CABG).
METHODS


A randomized clinical trial was conducted with patients undergoing CABG surgery. Patients were randomized into three groups: Group 10, PEEP of 10 cmH2O; Group 12, PEEP of 12 cmH2O; and Group 15, PEEP of 15 cmH2O. After the randomization, all patients underwent gas analysis at three moments: (1) before lung expansion therapy (LET); (2) 30 minutes after LET; and (3) one hour after extubation.
RESULTS


Sixty-six patients were studied, of which 61.7% were men, with mean age of 64 ± 8.9 years. Patients allocated to Group 15 showed a significant improvement in gas exchange comparing pre- and post-expansion values (239±21 vs. 301±19, P<0,001) and the increase was maintained after extubation (278±26). Despite the use of high levels of PEEP, no significant hemodynamic change was evidenced.
CONCLUSION


It is concluded that high levels of PEEP (15 cmH2O) are beneficial for the improvement of gas exchange in patients undergoing CABG.",2019,"Patients allocated to Group 15 showed a significant improvement in gas exchange comparing pre- and post-expansion values (239±21 vs. 301±19, P<0,001) and the increase was maintained after extubation (278±26).","['patients undergoing CABG', 'Mechanically Ventilated Patients Submitted to Coronary Artery Bypass Grafting', 'patients undergoing CABG surgery', 'Sixty-six patients were studied, of which 61.7% were men, with mean age of 64 ± 8.9 years', 'patients undergoing coronary artery bypass grafting (CABG']","['lung expansion therapy (LET', 'Lung Expansion Therapy Using Positive End-Expiratory Pressure', 'PEEP of 10 cmH2O; Group 12, PEEP of 12 cmH2O; and Group 15, PEEP of 15 cmH2O', 'positive end-expiratory pressure (PEEP']",['gas exchange comparing pre- and post-expansion values'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0086562', 'cui_str': 'LET'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C0863179', 'cui_str': 'Peeping'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",66.0,0.194928,"Patients allocated to Group 15 showed a significant improvement in gas exchange comparing pre- and post-expansion values (239±21 vs. 301±19, P<0,001) and the increase was maintained after extubation (278±26).","[{'ForeName': 'André Luiz Lisboa', 'Initials': 'ALL', 'LastName': 'Cordeiro', 'Affiliation': 'Escola Bahiana de Medicina e Saúde Pública (Bahiana) Unidade Acadêmica Brotas Salvador Bahia Brazil Escola Bahiana de Medicina e Saúde Pública (Bahiana) - Unidade Acadêmica Brotas, Salvador, Bahia, Brazil.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Carvalho', 'Affiliation': 'Instituto Nobre de Cardiologia Feira de Santana Bahia Brazil Instituto Nobre de Cardiologia (INCARDIO), Feira de Santana, Bahia, Brazil.'}, {'ForeName': 'Maria Clara', 'Initials': 'MC', 'LastName': 'Leite', 'Affiliation': 'Instituto Nobre de Cardiologia Feira de Santana Bahia Brazil Instituto Nobre de Cardiologia (INCARDIO), Feira de Santana, Bahia, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Vila-Flor', 'Affiliation': 'Instituto Nobre de Cardiologia Feira de Santana Bahia Brazil Instituto Nobre de Cardiologia (INCARDIO), Feira de Santana, Bahia, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Freitas', 'Affiliation': 'Instituto Nobre de Cardiologia Feira de Santana Bahia Brazil Instituto Nobre de Cardiologia (INCARDIO), Feira de Santana, Bahia, Brazil.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Sousa', 'Affiliation': 'Instituto Nobre de Cardiologia Feira de Santana Bahia Brazil Instituto Nobre de Cardiologia (INCARDIO), Feira de Santana, Bahia, Brazil.'}, {'ForeName': 'Quetla', 'Initials': 'Q', 'LastName': 'Oliveira', 'Affiliation': 'Instituto Nobre de Cardiologia Feira de Santana Bahia Brazil Instituto Nobre de Cardiologia (INCARDIO), Feira de Santana, Bahia, Brazil.'}, {'ForeName': 'André Raimundo', 'Initials': 'AR', 'LastName': 'Guimarães', 'Affiliation': 'Instituto Nobre de Cardiologia Feira de Santana Bahia Brazil Instituto Nobre de Cardiologia (INCARDIO), Feira de Santana, Bahia, Brazil.'}]",Brazilian journal of cardiovascular surgery,['10.21470/1678-9741-2019-0016']
2813,31554943,Effect of multiple subconjunctival conbercept injections as an adjuvant to the surgical treatment of pterygium: a prospective randomised comparative 6-month follow-up study.,"OBJECTIVE


To evaluate the safety and efficacy of multiple subconjunctival injections of conbercept for pterygium patients after surgery.
METHODS


As a prospective randomised interventional trial, 96 eyes from 96 patients with a tendency to recur were collected and divided randomly into conbercept and 5-fluorouracil groups on the 5th day after pterygium. All patients received three subconjunctival injections of conbercept (0.2 ml) or 5-fluorouracil (0.2 ml) on the 5th day (baseline), and 2 and 4 weeks post-operatively. The pterygium morphology, colour intensity, recurrence, and complications were recorded and analysed pre-1st injection and 1 day, 1 week, 1 month, 3 months, and 6 months post-3rd injection. Moreover, no patient was drop-out.
RESULTS


There were striking differences between the two groups on post-3rd injections 1 day, 1 week, 1 month, 3 months, and 6 months (p = 0.001, 0.002, 0.000, 0.000, and 0.002, respectively) with respect to colour intensity: the eyes in conbercept group were lighter than the 5-Fu group. On post-3rd injection 6 months, prominent disparities existed between the two groups with respect to pterygium morphology (p = 0.006) and recurrence (p = 0.002), occurred in the conbercept group prior to the 5-Fu group. Moreover, corneal abrasions were not noted in the conbercept group, which was significantly less than the 5-Fu group (17/48; p = 0.000). There was no conspicuous discrepancy between the two groups with respect to subconjunctival haemorrhage (p = 0.789) and persistent epithelial defects (p = 0.078).
CONCLUSION


Multiple subconjunctival conbercept injections as an adjunct therapy for pterygium surgery was shown to be safe, effective, and well-tolerated.",2020,"On post-3rd injection 6 months, prominent disparities existed between the two groups with respect to pterygium morphology (p = 0.006) and recurrence (p = 0.002), occurred in the conbercept group prior to the 5-Fu group.","['pterygium', '96 eyes from 96 patients with a tendency to recur', 'pterygium patients after surgery']","['5-Fu', 'multiple subconjunctival conbercept injections', 'conbercept and 5-fluorouracil', 'multiple subconjunctival injections of conbercept', 'subconjunctival injections of conbercept (0.2\u2009ml) or 5-fluorouracil']","['corneal abrasions', 'pterygium morphology, colour intensity, recurrence, and complications', 'subconjunctival haemorrhage', 'persistent epithelial defects', 'safe, effective, and well-tolerated', 'recurrence', 'pterygium morphology', 'safety and efficacy']","[{'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0442183', 'cui_str': 'Subconjunctival (qualifier value)'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0197180', 'cui_str': 'Subconjunctival injection (procedure)'}, {'cui': 'C4517436', 'cui_str': '0.2'}]","[{'cui': 'C0010032', 'cui_str': 'Corneal abrasion (disorder)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0038534', 'cui_str': 'Subconjunctival hemorrhage (disorder)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0163744,"On post-3rd injection 6 months, prominent disparities existed between the two groups with respect to pterygium morphology (p = 0.006) and recurrence (p = 0.002), occurred in the conbercept group prior to the 5-Fu group.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China.'}, {'ForeName': 'Quanxi', 'Initials': 'Q', 'LastName': 'Tian', 'Affiliation': 'School of Information Management and statistics, Hubei University of Economics, No. 8 Yangqiaohu Road, 430205, Wuhan, Hubei, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Zheng', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China.'}, {'ForeName': 'Donglai', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': ""Department of Ophthalmology, The Second People's Hospital of Honghu, No 142. Xinjian Road, 433202, Honghu, Hubei, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Ke', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China. keminyk@163.com.'}]","Eye (London, England)",['10.1038/s41433-019-0596-7']
2814,32045501,Baclofen modulates cardiovascular responses to appetitive cues in treatment-seeking alcohol use disorder individuals.,"OBJECTIVE


To assess whether baclofen-treated alcohol dependent participants show different subjective and psychophysiological responses to appetitive cues during an alcohol cue reactivity task compared to placebo, and whether these responses are associated with prospective drinking outcomes.
METHODS


Forty-two alcohol dependent participants (placebo: n = 12, low-dose baclofen [30 mg/day] n = 18, high-dose baclofen [75 mg/day]: n = 12) completed an alcohol cue reactivity task, whereby water and alcohol beverage cues were presented, with subsequent recovery periods, and subjective alcohol craving and psychophysiological indices (skin conductance; cardiovascular measures: heart rate, high-frequency heart rate variability) were recorded.
RESULTS


High-dose baclofen-treated participants showed both overall cue reactivity to water and alcohol cues and greater recovery effects during recovery periods, revealed by high-frequency heart rate variability, when compared to low-dose- and placebo-treated participants. There were no medication effects on subjective craving. In high-dose baclofen participants only, there was a predictive effect of lower baseline heart rate variability and fewer post-test percentage of heavy drinking days.
CONCLUSION


There was a dose-specific rescuing effect of high-dose baclofen on the dynamic modulation of cardiovascular responses to eliciting cues. Investigation of treatment responses using psychophysiological techniques may elucidate baclofen's mechanisms of action, and identify subgroups amenable to treatment.",2020,There was a dose-specific rescuing effect of high-dose baclofen on the dynamic modulation of cardiovascular responses to eliciting cues.,"['treatment-seeking alcohol use disorder individuals', 'Forty-two alcohol dependent participants ']","['Baclofen', 'low-dose baclofen [30\u2009mg/day] n = 18, high-dose baclofen [75\u2009mg/day]: n = 12) completed an alcohol cue reactivity task, whereby water and alcohol beverage cues', 'placebo', 'baclofen-treated alcohol']","['overall cue reactivity to water and alcohol cues', 'subjective alcohol craving and psychophysiological indices (skin conductance; cardiovascular measures: heart rate, high-frequency heart rate variability', 'subjective craving']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0199659', 'cui_str': 'Cardiovascular measure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}]",42.0,0.0627443,There was a dose-specific rescuing effect of high-dose baclofen on the dynamic modulation of cardiovascular responses to eliciting cues.,"[{'ForeName': 'Warren B', 'Initials': 'WB', 'LastName': 'Logge', 'Affiliation': 'Discipline of Addiction Medicine, Central Clinical School, Faculty of Medicine and Health, University of Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Baillie', 'Affiliation': 'Faculty of Health Sciences, University of Sydney, New South Wales, Australia.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Haber', 'Affiliation': 'Discipline of Addiction Medicine, Central Clinical School, Faculty of Medicine and Health, University of Sydney, New South Wales, Australia.'}, {'ForeName': 'Kirsten C', 'Initials': 'KC', 'LastName': 'Morley', 'Affiliation': 'Discipline of Addiction Medicine, Central Clinical School, Faculty of Medicine and Health, University of Sydney, New South Wales, Australia.'}]",Human psychopharmacology,['10.1002/hup.2722']
2815,31155138,The Effects of the Angiotensin II Receptor Antagonist Losartan on Appetitive Versus Aversive Learning: A Randomized Controlled Trial.,"BACKGROUND


Exposure therapy is a first-line treatment for anxiety disorders but remains ineffective in a large proportion of patients. A proposed mechanism of exposure involves inhibitory learning whereby the association between a stimulus and an aversive outcome is suppressed by a new association with an appetitive or neutral outcome. The blood pressure medication losartan augments fear extinction in rodents and may have similar synergistic effects on human exposure therapy, but the exact cognitive mechanisms underlying these effects remain unknown.
METHODS


We used a reinforcement learning paradigm with compound rewards and punishments to test the prediction that losartan augments learning from appetitive relative to aversive outcomes. In a double-blind parallel design, healthy volunteers were randomly assigned to single-dose losartan (50 mg) (n = 28) versus placebo (n = 25). Participants then performed a reinforcement learning task, which simultaneously probes appetitive and aversive learning. Participant choice behavior was analyzed using both a standard reinforcement learning model and analysis of choice switching behavior.
RESULTS


Losartan significantly reduced learning rates from aversive events (losses) when participants were first exposed to the novel task environment, while preserving learning from positive outcomes. The same effect was seen in choice switching behavior.
CONCLUSIONS


This study shows that losartan enhances learning from positive relative to negative events. This effect may represent a computationally defined neurocognitive mechanism by which the drug could enhance the effect of exposure in clinical populations.",2019,"RESULTS


Losartan significantly reduced learning rates from aversive events (losses) when participants were first exposed to the novel task environment, while preserving learning from positive outcomes.",['healthy volunteers'],"['reinforcement learning task, which simultaneously probes appetitive and aversive learning', 'Angiotensin II Receptor Antagonist Losartan', 'placebo', 'Losartan', 'losartan']","['learning rates', 'Appetitive Versus Aversive Learning']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0035007', 'cui_str': 'Reinforcement'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II Receptor Blockers'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}]",,0.114376,"RESULTS


Losartan significantly reduced learning rates from aversive events (losses) when participants were first exposed to the novel task environment, while preserving learning from positive outcomes.","[{'ForeName': 'Erdem', 'Initials': 'E', 'LastName': 'Pulcu', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Lorika', 'Initials': 'L', 'LastName': 'Shkreli', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, United Kingdom; Department of Psychology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Carolina Guzman', 'Initials': 'CG', 'LastName': 'Holst', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, United Kingdom; Department of Experimental Psychology, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Marcella L', 'Initials': 'ML', 'LastName': 'Woud', 'Affiliation': 'Department of Psychology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, California; Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Browning', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, United Kingdom; Oxford Health National Health Service Trust, Oxford, United Kingdom.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Reinecke', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, United Kingdom. Electronic address: andrea.reinecke@psych.ox.ac.uk.'}]",Biological psychiatry,['10.1016/j.biopsych.2019.04.010']
2816,31805311,Sustained successful peanut oral immunotherapy associated with low basophil activation and peanut-specific IgE.,"BACKGROUND


Oral immunotherapy (OIT) can successfully desensitize many peanut-allergic subjects, but clinical tolerance diminishes over time on discontinuation, or low-dose maintenance, of peanut. Therefore, to improve the efficacy and sustainability of such therapy, we sought to identify biomarkers and clinical tools that can predict therapeutic outcomes and monitor treatment responses.
OBJECTIVE


We evaluated whether basophil activation in whole blood, and plasma levels of peanut-specific immunoglobulins, are useful biomarkers for peanut OIT.
METHODS


We longitudinally measured, before, during, and after OIT, basophil activation in whole blood ex vivo in response to peanut stimulation, and peanut-specific IgE (sIgE) and peanut-specific IgG 4  (sIgG 4 ), in a large, single-site, double-blind, randomized, placebo-controlled, phase 2 peanut OIT study. We compared basophil responsiveness and peanut-specific immunoglobulins between those who were clinically reactive and those who were tolerant to peanut oral challenges.
RESULTS


Peanut OIT significantly decreased basophil activation, peanut sIgE, Ara h 1, Ara h 2, and Ara h 3 IgE levels, and sIgE/total IgE, but increased sIgG 4 /sIgE. Participants who became reactive to 4 g of peanut 13 weeks off active OIT exhibited higher peanut-induced basophil activation ex vivo and higher peanut sIgE levels and sIgE/total IgE, but lower sIgG 4 /sIgE. Notably, participants entering the study with low basophil responsiveness were more likely to achieve treatment success. Substantial suppression of basophil activation was required to maintain long-term clinical tolerance after peanut OIT.
CONCLUSIONS


Assessments of peanut-induced basophil activation and peanut-specific immunoglobulins can help to predict treatment outcomes, and to differentiate transient desensitization versus sustained unresponsiveness after OIT.",2020,"Peanut OIT significantly decreased basophil activation, peanut sIgE, Ara h 1, Ara h 2, and Ara h 3 IgE levels, and sIgE/total IgE, but increased sIgG",[],"['placebo', 'Oral immunotherapy (OIT', 'peanut-specific IgE (sIgE) and peanut-specific IgG 4  ']","['basophil activation ex\xa0vivo and higher peanut sIgE levels and sIgE/total IgE, but lower sIgG', 'basophil activation, peanut sIgE, Ara h 1, Ara h 2, and Ara h 3 IgE levels, and sIgE/total IgE, but increased sIgG', 'low basophil activation and peanut-specific IgE']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C1270751', 'cui_str': 'Arachis hypogaea specific immunoglobulin E (substance)'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}]","[{'cui': 'C4316898', 'cui_str': 'Basophil, segmented (cell)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0063241', 'cui_str': 'hypoxanthine arabinoside'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1270751', 'cui_str': 'Arachis hypogaea specific immunoglobulin E (substance)'}]",,0.0751136,"Peanut OIT significantly decreased basophil activation, peanut sIgE, Ara h 1, Ara h 2, and Ara h 3 IgE levels, and sIgE/total IgE, but increased sIgG","[{'ForeName': 'Mindy', 'Initials': 'M', 'LastName': 'Tsai', 'Affiliation': 'Department of Pathology, Stanford University School of Medicine, Stanford, Calif; Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, Calif.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Mukai', 'Affiliation': 'Department of Pathology, Stanford University School of Medicine, Stanford, Calif; Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, Calif.'}, {'ForeName': 'R Sharon', 'Initials': 'RS', 'LastName': 'Chinthrajah', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, Calif; Department of Medicine, Stanford University School of Medicine, Stanford, Calif.'}, {'ForeName': 'Kari C', 'Initials': 'KC', 'LastName': 'Nadeau', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, Calif; Department of Medicine, Stanford University School of Medicine, Stanford, Calif.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Galli', 'Affiliation': 'Department of Pathology, Stanford University School of Medicine, Stanford, Calif; Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, Calif; Department of Microbiology and Immunology, Stanford University School of Medicine, Stanford, Calif. Electronic address: sgalli@stanford.edu.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.10.038']
2817,31317511,Using Adherence-Contingent Rebates on Chronic Disease Treatment Costs to Promote Medication Adherence: Results from a Randomized Controlled Trial.,"BACKGROUND


Poor adherence to medications is a global public health concern with substantial health and cost implications, especially for chronic conditions. In the USA, poor adherence is estimated to cause 125,000 deaths and cost $US100 billion annually. The most successful adherence-promoting strategies that have been identified so far have moderate effect, are relatively costly, and raise availability, feasibility, and/or scalability issues.
OBJECTIVE


The main objective of SIGMA (Study on Incentives for Glaucoma Medication Adherence) was to measure the effectiveness on medication adherence of a novel incentive strategy based on behavioral economics that we refer to as adherence-contingent rebates. These rebates offered patients a near-term benefit while leveraging loss aversion and regret and increasing the salience of adherence.
METHODS


SIGMA is a 6-month randomized, controlled, open-label, single-center superiority trial with two parallel arms. A total of 100 non-adherent glaucoma patients from the Singapore National Eye Centre were randomized into intervention (adherence-contingent rebates) and usual care (no rebates) arms in a 1:1 ratio. The primary outcome was the mean change from baseline in percentage of adherent days at Month 6. The trial registration number is NCT02271269 and a detailed study protocol has been published elsewhere.
FINDINGS


We found that participants who were offered adherence-contingent rebates were adherent to all their medications on 73.1% of the days after 6 months, which is 12.2 percentage points (p = 0.027) higher than in those not receiving the rebates after controlling for baseline differences. This better behavioral outcome was achieved by rebates averaging 8.07 Singapore dollars ($US5.94 as of 2 November 2017) per month during the intervention period.
CONCLUSION


This study shows that simultaneously leveraging several insights from behavioral economics can significantly improve medication adherence rates. The relatively low cost of the rebates and significant health and cost implications of medication non-adherence suggest that this strategy has the potential to cost-effectively improve health outcomes for many conditions.",2019,"This better behavioral outcome was achieved by rebates averaging 8.07 Singapore dollars ($US5.94 as of 2 November 2017) per month during the intervention period.
",['100 non-adherent glaucoma patients from the Singapore National Eye Centre'],['intervention (adherence-contingent rebates) and usual care (no rebates'],"['behavioral outcome', 'medication adherence rates', 'mean change from baseline in percentage of adherent days']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",[],"[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.142135,"This better behavioral outcome was achieved by rebates averaging 8.07 Singapore dollars ($US5.94 as of 2 November 2017) per month during the intervention period.
","[{'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Bilger', 'Affiliation': 'Health Economics and Policy, Vienna University of Business and Economics, Welthandelsplatz 1, Building D4, 1020, Vienna, Austria. marcel.bilger@wu.ac.at.'}, {'ForeName': 'Tina T', 'Initials': 'TT', 'LastName': 'Wong', 'Affiliation': 'Singapore National Eye Centre, Singapore Eye Research Institute, Singapore, Singapore.'}, {'ForeName': 'Jia Yi', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Singapore National Eye Centre, Singapore Eye Research Institute, Singapore, Singapore.'}, {'ForeName': 'Kaye L', 'Initials': 'KL', 'LastName': 'Howard', 'Affiliation': 'Health Services & Systems Research Program, Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Filipinas G', 'Initials': 'FG', 'LastName': 'Bundoc', 'Affiliation': 'Health Services & Systems Research Program, Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Ecosse L', 'Initials': 'EL', 'LastName': 'Lamoureux', 'Affiliation': 'Health Services & Systems Research Program, Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Health Services & Systems Research Program, Duke-NUS Medical School, Singapore, Singapore.'}]",Applied health economics and health policy,['10.1007/s40258-019-00497-0']
2818,30471848,Trial-based cost-effectiveness analysis of toric versus monofocal intraocular lenses in cataract patients with bilateral corneal astigmatism in the Netherlands.,"PURPOSE


To evaluate the cost-effectiveness of toric versus monofocal intraocular lens (IOL) implantation in cataract patients with bilateral corneal astigmatism.
SETTING


Two ophthalmology clinics in the Netherlands.
DESIGN


Prospective cost-effectiveness analysis.
METHODS


Resource-use data were collected over a 6-month postoperative period. Consecutive patients with bilateral age-related cataract and 1.25 diopters or more of corneal astigmatism were included in the economic evaluation. Patients were randomized to phacoemulsification with bilateral toric or monofocal IOL implantation. All relevant resources were included in the cost analysis. The base-case analysis was performed from a societal perspective based on quality-adjusted life years (QALYs). The main outcome was the incremental cost-effectiveness ratio.
RESULTS


The analysis comprised 77 consecutive patients (33 toric IOL; 44 monofocal IOL). Societal costs were higher in the toric IOL group (€3203 [$3864]) than in the monofocal IOL group (€2796 [US$3373]). QALYs were slightly lower in the toric IOL group (0.30 versus 0.31; P = .75). Toric IOLs were therefore inferior to monofocal IOLs from a cost-effectiveness perspective. The cost-effectiveness probability ranged from 1% to 15%, assuming a ceiling ratio for the incremental cost-effectiveness ratio of €2500 to €20 000 per QALY.
CONCLUSIONS


From a societal perspective, bilateral toric IOL implantation in cataract patients with corneal astigmatism was not cost-effective compared with monofocal IOL implantation. Copayment by patients should therefore be considered.",2019,Societal costs were higher in the toric IOL group (€3203 [$3864]) than in the monofocal IOL group (€2796 [US$3373]).,"['cataract patients with bilateral corneal astigmatism in the Netherlands', '77 consecutive patients (33 toric IOL; 44 monofocal IOL', 'cataract patients with bilateral corneal astigmatism', 'Two ophthalmology clinics in the Netherlands', 'cataract patients with corneal astigmatism', 'Consecutive patients with bilateral age-related cataract and 1.25 diopters or more of corneal astigmatism were included in the economic evaluation']","['toric versus monofocal intraocular lens (IOL) implantation', 'phacoemulsification with bilateral toric or monofocal IOL implantation', 'toric versus monofocal intraocular lenses']","['Societal costs', 'incremental cost-effectiveness ratio', 'cost-effectiveness probability']","[{'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0339682', 'cui_str': 'Corneal astigmatism'}, {'cui': 'C3838844', 'cui_str': 'Ophthalmology clinic'}, {'cui': 'C0036646', 'cui_str': 'Age-related cataract (disorder)'}, {'cui': 'C4517497', 'cui_str': '1.25 (qualifier value)'}, {'cui': 'C0439486', 'cui_str': 'Diopters - (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0150099', 'cui_str': 'Economic Evaluation'}]","[{'cui': 'C0023311', 'cui_str': 'Lens Implantation, Intraocular'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",77.0,0.0474482,Societal costs were higher in the toric IOL group (€3203 [$3864]) than in the monofocal IOL group (€2796 [US$3373]).,"[{'ForeName': 'Rob W P', 'Initials': 'RWP', 'LastName': 'Simons', 'Affiliation': 'University Eye Clinic Maastricht, Maastricht University Medical Centre+, Maastricht, the Netherlands. Electronic address: rob.simons@mumc.nl.'}, {'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'Visser', 'Affiliation': 'University Eye Clinic Maastricht, Maastricht University Medical Centre+, Maastricht, the Netherlands.'}, {'ForeName': 'Frank J H M', 'Initials': 'FJHM', 'LastName': 'van den Biggelaar', 'Affiliation': 'University Eye Clinic Maastricht, Maastricht University Medical Centre+, Maastricht, the Netherlands.'}, {'ForeName': 'Rudy M M A', 'Initials': 'RMMA', 'LastName': 'Nuijts', 'Affiliation': 'University Eye Clinic Maastricht, Maastricht University Medical Centre+, Maastricht, the Netherlands.'}, {'ForeName': 'Carroll A B', 'Initials': 'CAB', 'LastName': 'Webers', 'Affiliation': 'University Eye Clinic Maastricht, Maastricht University Medical Centre+, Maastricht, the Netherlands.'}, {'ForeName': 'Noel J C', 'Initials': 'NJC', 'LastName': 'Bauer', 'Affiliation': 'University Eye Clinic Maastricht, Maastricht University Medical Centre+, Maastricht, the Netherlands.'}, {'ForeName': 'Henny J M', 'Initials': 'HJM', 'LastName': 'Beckers', 'Affiliation': 'University Eye Clinic Maastricht, Maastricht University Medical Centre+, Maastricht, the Netherlands.'}, {'ForeName': 'Carmen D', 'Initials': 'CD', 'LastName': 'Dirksen', 'Affiliation': 'Department of Clinical Epidemiology and Medical Technology Assessment, CAPHRI School for Public Health and Primary Care, Maastricht University Medical Centre+, Maastricht, the Netherlands.'}]",Journal of cataract and refractive surgery,['10.1016/j.jcrs.2018.09.019']
2819,29137830,"Efficacy and Safety of Tamsulosin in Medical Expulsive Therapy for Distal Ureteral Stones with Renal Colic: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial.","BACKGROUND


Recent large high-quality trials have questioned the clinical effectiveness of medical expulsive therapy using tamsulosin for ureteral stones.
OBJECTIVE


To evaluate the efficacy and safety of tamsulosin for distal ureteral stones compared with placebo.
DESIGN, SETTING, AND PARTICIPANTS


We conducted a double-blind, placebo-controlled study of 3296 patients with distal ureteral stones, across 30 centers, to evaluate the efficacy and safety of tamsulosin.
INTERVENTION


Participants were randomly assigned (1:1) into tamsulosin (0.4mg) or placebo groups for 4 wk.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The primary end point of analysis was the overall stone expulsion rate, defined as stone expulsion, confirmed by negative findings on computed tomography, over a 28-d surveillance period. Secondary end points included time to stone expulsion, use of analgesics, and incidence of adverse events.
RESULTS AND LIMITATIONS


Among 3450 patients randomized between September 1, 2011, and August 31, 2013, 3296 (96%) were included in the primary analysis. Tamsulosin benefits from a higher stone expulsion rate than the placebo (86% vs 79%; p<0.001) for distal ureteral stones. Subgroup analysis identified a specific benefit of tamsulosin for the treatment of large distal ureteral stones (>5mm). Considering the secondary end points, tamsulosin-treated patients reported a shorter time to expulsion (p<0.001), required lower use of analgesics compared with placebo (p<0.001), and significantly relieved renal colic (p<0.001). No differences in the incidence of adverse events were identified between the two groups.
CONCLUSIONS


Our data suggest that tamsulosin use benefits distal ureteral stones in facilitating stone passage and relieving renal colic. Subgroup analyses find that tamsulosin provides a superior expulsion rate for stones >5mm, but no effect for stones ≤5mm.
PATIENT SUMMARY


In this report, we looked at the efficacy and safety of tamsulosin for the treatment of distal ureteral stones. We find that tamsulosin significantly facilitates the passage of distal ureteral stones and relieves renal colic.",2018,"Subgroup analyses find that tamsulosin provides a superior expulsion rate for stones >5mm, but no effect for stones ≤5mm.
","['3450 patients randomized between September 1, 2011, and August 31, 2013, 3296 (96%) were included in the primary analysis', 'distal ureteral stones', 'Distal Ureteral Stones with Renal Colic', '3296 patients with distal ureteral stones, across 30 centers']","['Placebo', 'tamsulosin', 'Tamsulosin', 'placebo']","['stone expulsion rate', 'renal colic', 'overall stone expulsion rate, defined as stone expulsion', 'passage of distal ureteral stones and relieves renal colic', 'time to stone expulsion, use of analgesics, and incidence of adverse events', 'superior expulsion rate', 'shorter time to expulsion', 'efficacy and safety', 'Efficacy and Safety', 'incidence of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}, {'cui': 'C0152169', 'cui_str': 'Acute Renal Colic'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}]","[{'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C1293107', 'cui_str': 'Expulsion (procedure)'}, {'cui': 'C0152169', 'cui_str': 'Acute Renal Colic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}, {'cui': 'C1301771', 'cui_str': 'Relieved'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",3296.0,0.474415,"Subgroup analyses find that tamsulosin provides a superior expulsion rate for stones >5mm, but no effect for stones ≤5mm.
","[{'ForeName': 'Zhangqun', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Hubei Institute of Urology, Wuhan, China.'}, {'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'Zeng', 'Affiliation': 'The Center of Minimally-invasive Surgery, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Hubei Institute of Urology, Wuhan, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Tang', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Hubei Institute of Urology, Wuhan, China.'}, {'ForeName': 'Xiaochun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'The Institute of Urology, Peking University, Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Weibing', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Urology and Nephrology, The Third Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Urology, Huashan Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Lingwu', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, the First Affiliated Hospital of Zhongshan University, Guangzhou, China.'}, {'ForeName': 'Xingfa', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Urology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Xiankui', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, the First Affiliated Hospital of Chinese Medical University, Shenyang, China.'}, {'ForeName': 'Yaoliang', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Urology, the First Affiliated Hospital of Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Tiejun', 'Initials': 'T', 'LastName': 'Pan', 'Affiliation': 'Department of Urology, Wuhan General Hospital of Guangzhou Military Region, Wuhan, China.'}, {'ForeName': 'Jinchun', 'Initials': 'J', 'LastName': 'Xing', 'Affiliation': 'Department of Urology, the First Affiliated Hospital of Xiamen University, Xiamen, China.'}, {'ForeName': 'Shusheng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': ""Department of Urology, the First People's Hospital of Ningbo City, Ningbo University Medical School, Ningbo, China.""}, {'ForeName': 'Xiaojian', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'Department of Urology, JiangSu Province Hospital of Traditional Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Wenxi', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Department of Urology, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, China.'}, {'ForeName': 'Jianggen', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Urology, the People's Hospital of Shenzhen, Shenzhen, China.""}, {'ForeName': 'Yonghai', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Shantou Central Hospital, Shantou, China.'}, {'ForeName': 'Qiwu', 'Initials': 'Q', 'LastName': 'Mi', 'Affiliation': ""Department of Urology, the People's Hospital of Dongguan, Dongguan, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Department of Urology, Xiangya Hospital of Centra South University, Changsha, China.'}, {'ForeName': 'Jiongming', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Urology, the Second Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Weilie', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'Department of Urology, Guangzhou General Hospital of Guangzhou Military Region, Guangzhou, China.'}, {'ForeName': 'Peiyu', 'Initials': 'P', 'LastName': 'Liang', 'Affiliation': 'Department of Urology, the Affiliated Hospital of Hainan Medical College, Haikou, China.'}, {'ForeName': 'Zhaolin', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': ""Department of Urology, the People's Hospital of Guizhou Province, Guiyang, China.""}, {'ForeName': 'Changbao', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, the Second Affiliated Hospital of Zhengzhou University Medical School, Zhengzhou, China.'}, {'ForeName': 'Yongfu', 'Initials': 'Y', 'LastName': 'Long', 'Affiliation': 'Department of Urology, Shaoyang Central Hospital, Shaoyang, China.'}, {'ForeName': 'Yongbin', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'Department of Urology, Jiangmen Hospital of Zhongshan University, Jiangmen, China.'}, {'ForeName': 'Siping', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Meizhou Hospital of Zhongshan University, Meizhou, China.'}, {'ForeName': 'Guoqing', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Foshan Maternal and Child Health Care Hospital of Nanfang Medical University, Foshan, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, Nanhai Hospital of Nanfang Medical University.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Hubei Institute of Urology, Wuhan, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Hubei Institute of Urology, Wuhan, China. Electronic address: zhqchen8366@163.com.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Hubei Institute of Urology, Wuhan, China. Electronic address: xuhuawhu@163.com.'}]",European urology,['10.1016/j.eururo.2017.10.033']
2820,32139926,A study to evaluate and compare intubating laryngeal mask airway and air-Q intubating laryngeal airway for intubation using Parker Flex Tip tube.,"Background and Aims


Though manufacturer recommendations suggest use of specific endotracheal tube (ETT) with intubating laryngeal mask airway (ILMA) and air-Q intubating laryngeal airway (ILA), Parker Flex Tip tube introduced by J D Parker has certain advantages and is also cost-effective. This study was conducted to compare ILMA and air-Q ILA for intubation using Parker Flex Tip tube.
Methods


Patients of either gender, aged 18-60 years, scheduled for elective surgery requiring endotracheal intubation were included in this study. In group A ( n  = 55), blind intubation was done through ILMA using Parker Flex Tip tube and in group B ( n  = 55), blind intubation was done through air-Q ILA using Parker Flex Tip tube. Success rate, number of attempts, ease and a total time of intubation were recorded.
Results


Intubation was successful in 54 patients (98.2%) in group A and in 46 patients (85.2%) in group B ( P  = 0.026). Intubation was significantly easy with ILMA ( P  = 0.048). Manoeuvres for intubation were used in 10.9% patients in group A while it was used in 27.8% patients in group B. Significantly, more manoeuvres were required with air-Q ILA for intubation ( P  = 0.026). Number of attempts for ETT placement ( P  = 0.092), insertion time of ETT (T T ) ( P  = 0.472) and total time taken for successful intubation ( P  = 0.526) were comparable in both the groups.
Conclusion


The intubating laryngeal mask airway was superior to the air-Q intubating laryngeal airway for blind intubation using Parker Flex Tip tube.",2020,"Number of attempts for ETT placement ( P  = 0.092), insertion time of ETT (T T )","['Methods\n\n\nPatients of either gender, aged 18-60 years, scheduled for elective surgery requiring endotracheal intubation']","['ILMA and air-Q ILA', 'intubating laryngeal mask airway and air-Q intubating laryngeal airway for intubation using Parker Flex Tip tube', 'specific endotracheal tube (ETT) with intubating laryngeal mask airway (ILMA) and air-Q intubating laryngeal airway (ILA']","['Success rate, number of attempts, ease and a total time of intubation', 'insertion time of ETT (T T ', 'total time taken for successful intubation']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C3873831', 'cui_str': 'Laryngeal airway'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube, device (physical object)'}, {'cui': 'C1275745', 'cui_str': 'Intubating laryngeal mask airway'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",,0.0701822,"Number of attempts for ETT placement ( P  = 0.092), insertion time of ETT (T T )","[{'ForeName': 'Teena', 'Initials': 'T', 'LastName': 'Bansal', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Pt. B.D. Sharma University of Health Sciences, Rohtak, Haryana, India.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Singhal', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Pt. B.D. Sharma University of Health Sciences, Rohtak, Haryana, India.'}, {'ForeName': 'Himani', 'Initials': 'H', 'LastName': 'Mittal', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Pt. B.D. Sharma University of Health Sciences, Rohtak, Haryana, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_584_19']
2821,32145005,Relations between gait characteristics and subjective visual vertical results in young adults.,"OBJECTIVE


Subjective visual vertical (SVV) deviation can indicate impairments of motion perception and spatial orientation in individuals with vestibular disorders. This study investigated the influence of SVV on tandem gait ability by assessing differences between temporal, spatial, and kinematic characteristics in young adults.
METHODS


We recruited sixteen young adults with increased SVV and 17 age-matched control subjects. All subjects recruited for this study were with no history of neurological or musculoskeletal diseases. Knee and hip-joint kinematic data, spatio-temporal parameters, and gait variability were measured during tandem gait.
RESULTS


Stride time variability and stride velocity variability were significantly greater in the experimental group than the control group (p < 0.05). In addition, a significant correlation was observed between stride time variability and SVV results (r = 0.345, p < 0.05). However, hip and knee joint angles were non-significantly different in the experimental and control groups (p > 0.05) and spatio-temporal parameters were similar between the two groups (p > 0.05).
CONCLUSION


Stride time variability and stride velocity variability during tandem gait were significantly different in the experimental and control groups. We presume that increased SVV deviation is related to greater gait variability during tandem gait.",2020,"RESULTS


Stride time variability and stride velocity variability were significantly greater in the experimental group than the control group (p < 0.05).","['young adults', 'All subjects recruited for this study were with no history of neurological or musculoskeletal diseases', 'sixteen young adults with increased SVV and 17 age-matched control subjects', 'individuals with vestibular disorders']","['SVV', 'Subjective visual vertical (SVV) deviation']","['Stride time variability and stride velocity variability', 'Knee and hip-joint kinematic data, spatio-temporal parameters, and gait variability', 'hip and knee joint angles', 'SVV deviation', 'stride time variability and SVV results', 'Stride time variability and stride velocity variability during tandem gait']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0026857', 'cui_str': 'Orthopedic Disorders'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2609434', 'cui_str': 'Vestibular disorders (SMQ)'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0019558', 'cui_str': 'Acetabulofemoral Joint'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231779', 'cui_str': 'Heel toe gait (finding)'}]",16.0,0.019152,"RESULTS


Stride time variability and stride velocity variability were significantly greater in the experimental group than the control group (p < 0.05).","[{'ForeName': 'In Hee', 'Initials': 'IH', 'LastName': 'Cho', 'Affiliation': 'Department of Clinical Science, Graduate School of Health and Welfare, Dankook University, Republic of Korea.'}, {'ForeName': 'Jung Won', 'Initials': 'JW', 'LastName': 'Kwon', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, Dankook University, Republic of Korea.'}, {'ForeName': 'Sang Seok', 'Initials': 'SS', 'LastName': 'Yeo', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, Dankook University, Republic of Korea.'}]",Journal of vestibular research : equilibrium & orientation,['10.3233/VES-200694']
2822,32144378,"Changes in body weight, adherence, and appetite during 2 years of calorie restriction: the CALERIE 2 randomized clinical trial.","BACKGROUND/OBJECTIVES


The Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy Phase 2 (CALERIE) study showed that individuals who are nonobese were able to undergo significant calorie restriction (CR), yet the time course changes in adherence, weight, and appetite are unknown. This analysis aimed to investigate the time course changes in adherence, body weight, and appetite during the CALERIE study.
SUBJECTS/METHODS


Overall, 143 participants (body mass index: 21.9-28.0 kg/m 2 ) were randomized to a CR group that aimed to achieve 25% CR for 2 years. Throughout the intervention, body weight was measured, and appetite was assessed through visual analogue scales. Algorithms were utilized with body weight measurements to calculate adherence percentile score. Participants targeted an adherence percentile score of 50, though being between 80 (lowest acceptable adherence) and 10 (highest acceptable adherence) was adequate. Polynomial regression analyses were used to assess time course changes.
RESULTS


Polynomials indicated that adherence percentile score increased above 50 after approximately week 20, although adherence remained acceptable (adherence percentile score less than 80) (R 2  = 0.89; P < 0.001). Weight loss occurred until approximately week 60 and then plateaued (R 2  ≥ 0.92; P < 0.001). Hunger and thirst increased (R 2  ≥ 0.30; P < 0.001), but the total increase in scale scores were <10 mm throughout the intervention.
CONCLUSIONS


In individuals who are nonobese, adherence to 25% CR declines after 20 weeks, but 2 years of CR that stimulates a meaningful reduction in weight, promotes aging-related benefits and negligibly affects appetite is viable.",2020,"Hunger and thirst increased (R 2  ≥ 0.30; P < 0.001), but the total increase in scale scores were <10 mm throughout the intervention.
","['individuals who are nonobese', '143 participants (body mass index: 21.9-28.0\u2009kg/m 2 ']",[],"['body weight', 'Weight loss', 'total increase in scale scores', 'body weight, adherence, and appetite', 'adherence, body weight, and appetite', 'adherence percentile score']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",[],"[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}]",143.0,0.0561506,"Hunger and thirst increased (R 2  ≥ 0.30; P < 0.001), but the total increase in scale scores were <10 mm throughout the intervention.
","[{'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Dorling', 'Affiliation': 'Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA, 70808, USA.'}, {'ForeName': 'Sai Krupa', 'Initials': 'SK', 'LastName': 'Das', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, 711 Washington St, Boston, MA, 02111, USA.'}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Racette', 'Affiliation': 'Washington University School of Medicine, 4444 Forest Park Ave., St. Louis, MO, 63108, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Apolzan', 'Affiliation': 'Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA, 70808, USA.'}, {'ForeName': 'Dachuan', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA, 70808, USA.'}, {'ForeName': 'Carl F', 'Initials': 'CF', 'LastName': 'Pieper', 'Affiliation': 'Duke University Medical Center, 10 Duke Medicine Circle, Durham, NC, 27710, USA.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA, 70808, USA. Corby.Martin@pbrc.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of clinical nutrition,['10.1038/s41430-020-0593-8']
2823,30742122,Neoadjuvant anti-PD-1 immunotherapy promotes a survival benefit with intratumoral and systemic immune responses in recurrent glioblastoma.,"Glioblastoma is the most common primary malignant brain tumor in adults and is associated with poor survival. The Ivy Foundation Early Phase Clinical Trials Consortium conducted a randomized, multi-institution clinical trial to evaluate immune responses and survival following neoadjuvant and/or adjuvant therapy with pembrolizumab in 35 patients with recurrent, surgically resectable glioblastoma. Patients who were randomized to receive neoadjuvant pembrolizumab, with continued adjuvant therapy following surgery, had significantly extended overall survival compared to patients that were randomized to receive adjuvant, post-surgical programmed cell death protein 1 (PD-1) blockade alone. Neoadjuvant PD-1 blockade was associated with upregulation of T cell- and interferon-γ-related gene expression, but downregulation of cell-cycle-related gene expression within the tumor, which was not seen in patients that received adjuvant therapy alone. Focal induction of programmed death-ligand 1 in the tumor microenvironment, enhanced clonal expansion of T cells, decreased PD-1 expression on peripheral blood T cells and a decreasing monocytic population was observed more frequently in the neoadjuvant group than in patients treated only in the adjuvant setting. These findings suggest that the neoadjuvant administration of PD-1 blockade enhances both the local and systemic antitumor immune response and may represent a more efficacious approach to the treatment of this uniformly lethal brain tumor.",2019,"Neoadjuvant PD-1 blockade was associated with upregulation of T cell- and interferon-γ-related gene expression, but downregulation of cell-cycle-related gene expression within the tumor, which was not seen in patients that received adjuvant therapy alone.","['recurrent glioblastoma', '35 patients with recurrent, surgically resectable glioblastoma']","['adjuvant, post-surgical programmed cell death protein 1 (PD-1) blockade alone', 'Neoadjuvant anti-PD-1 immunotherapy', 'neoadjuvant pembrolizumab', 'neoadjuvant and/or adjuvant therapy with pembrolizumab']","['PD-1 expression on peripheral blood T cells', 'monocytic population', 'overall survival', 'local and systemic antitumor immune response']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0007587', 'cui_str': 'Cell Death'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}]",35.0,0.14246,"Neoadjuvant PD-1 blockade was associated with upregulation of T cell- and interferon-γ-related gene expression, but downregulation of cell-cycle-related gene expression within the tumor, which was not seen in patients that received adjuvant therapy alone.","[{'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Cloughesy', 'Affiliation': 'Department of Neurology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA. tcloughesy@mednet.ucla.edu.'}, {'ForeName': 'Aaron Y', 'Initials': 'AY', 'LastName': 'Mochizuki', 'Affiliation': 'Division of Hematology/Oncology, Department of Pediatrics, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Joey R', 'Initials': 'JR', 'LastName': 'Orpilla', 'Affiliation': 'Department of Neurosurgery, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Willy', 'Initials': 'W', 'LastName': 'Hugo', 'Affiliation': 'Division of Dermatology, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Alexander H', 'Initials': 'AH', 'LastName': 'Lee', 'Affiliation': 'Department of Medical and Molecular Pharmacology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Tom B', 'Initials': 'TB', 'LastName': 'Davidson', 'Affiliation': 'Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Ellingson', 'Affiliation': 'Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Rytlewski', 'Affiliation': 'Adaptive Biotechnologies, Seattle, WA, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Sanders', 'Affiliation': 'Adaptive Biotechnologies, Seattle, WA, USA.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Kawaguchi', 'Affiliation': 'Department of Biostatistics, Fielding School of Public Health, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Du', 'Affiliation': 'Department of Biostatistics, Fielding School of Public Health, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Yong', 'Affiliation': 'Department of Pathology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Gaffey', 'Affiliation': 'Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Adam L', 'Initials': 'AL', 'LastName': 'Cohen', 'Affiliation': 'Department of Neurosurgery, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Ingo K', 'Initials': 'IK', 'LastName': 'Mellinghoff', 'Affiliation': 'Department of Neurology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Eudocia Q', 'Initials': 'EQ', 'LastName': 'Lee', 'Affiliation': 'Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Reardon', 'Affiliation': 'Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Neuro-Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Butowski', 'Affiliation': 'Department of Neurological Surgery, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Phioanh L', 'Initials': 'PL', 'LastName': 'Nghiemphu', 'Affiliation': 'Department of Neurology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Clarke', 'Affiliation': 'Department of Neurological Surgery, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Isabel C', 'Initials': 'IC', 'LastName': 'Arrillaga-Romany', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital Cancer Center, Boston, MA, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Colman', 'Affiliation': 'Department of Neurosurgery, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Kaley', 'Affiliation': 'Department of Neurology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'de Groot', 'Affiliation': 'Department of Neuro-Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Liau', 'Affiliation': 'Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Patrick Y', 'Initials': 'PY', 'LastName': 'Wen', 'Affiliation': 'Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Prins', 'Affiliation': 'Department of Medical and Molecular Pharmacology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA. rprins@mednet.ucla.edu.'}]",Nature medicine,['10.1038/s41591-018-0337-7']
2824,31853557,"Safety, tolerability, pharmacokinetics, and pharmacodynamics of low dose lysergic acid diethylamide (LSD) in healthy older volunteers.","Research has shown that psychedelics, such as lysergic acid diethylamide (LSD), have profound anti-inflammatory properties mediated by 5-HT 2A  receptor signaling, supporting their evaluation as a therapeutic for neuroinflammation associated with neurodegenerative disease.
OBJECTIVE


This study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally repeated administration of 5 μg, 10 μg, and 20 μg LSD in older healthy individuals. In the current paper, we present safety, tolerability, pharmacokinetics, and pharmacodynamic measures that relate to safety, tolerability, and dose response.
METHODS


This was a phase 1 double-blind, placebo-controlled, randomized study. Volunteers were randomly assigned to 1 of 4 dose groups (5 μg, 10 μg, 20 μg LSD, and placebo), and received their assigned dose on six occasions (i.e., every 4 days).
RESULTS


Forty-eight older healthy volunteers (mean age = 62.9 years) received placebo (n = 12), 5 μg (n = 12), 10 μg (n = 12), or 20 μg (n = 12) LSD. LSD plasma levels were undetectable for the 5 μg group and peak blood plasma levels for the 10 μg and 20 μg groups occurred at 30 min. LSD was well tolerated, and the frequency of adverse events was no higher than for placebo. Assessments of cognition, balance, and proprioception revealed no impairment.
CONCLUSIONS


Our results suggest safety and tolerability of orally administered 5 μg, 10 μg, and 20 μg LSD every fourth day over a 21-day period and support further clinical development of LSD for the treatment and prevention of Alzheimer's disease (AD).",2020,LSD plasma levels were undetectable for the 5 μg group and peak blood plasma levels for the 10 μg and 20 μg groups occurred at 30 min.,"['older healthy individuals', 'healthy older volunteers', 'Forty-eight older healthy volunteers (mean age\u2009=\u200962.9\xa0years) received']","['LSD', 'low dose lysergic acid diethylamide (LSD', 'placebo']","['safety, tolerability, and dose response', 'safety and tolerability', 'safety, tolerability, pharmacokinetics, and pharmacodynamics', 'frequency of adverse events', 'Safety, tolerability, pharmacokinetics, and pharmacodynamics', 'LSD plasma levels', 'peak blood plasma levels', 'Assessments of cognition, balance, and proprioception revealed no impairment', 'safety, tolerability, pharmacokinetics, and pharmacodynamic measures']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0443289', 'cui_str': 'Revealed (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",48.0,0.266889,LSD plasma levels were undetectable for the 5 μg group and peak blood plasma levels for the 10 μg and 20 μg groups occurred at 30 min.,"[{'ForeName': 'Neiloufar', 'Initials': 'N', 'LastName': 'Family', 'Affiliation': 'Eleusis Benefit Corporation, New York, NY, USA. neiloufar.family@eleusisltd.com.'}, {'ForeName': 'Emeline L', 'Initials': 'EL', 'LastName': 'Maillet', 'Affiliation': 'Eleusis Benefit Corporation, New York, NY, USA.'}, {'ForeName': 'Luke T J', 'Initials': 'LTJ', 'LastName': 'Williams', 'Affiliation': 'Eleusis Benefit Corporation, New York, NY, USA.'}, {'ForeName': 'Erwin', 'Initials': 'E', 'LastName': 'Krediet', 'Affiliation': 'Eleusis Benefit Corporation, New York, NY, USA.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Carhart-Harris', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Tim M', 'Initials': 'TM', 'LastName': 'Williams', 'Affiliation': 'Bristol University, Bristol, UK.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Nichols', 'Affiliation': 'Department of Pharmacology and Experimental Therapeutics, LSU Health Sciences Center, New Orleans, LA, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Goble', 'Affiliation': 'San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Shlomi', 'Initials': 'S', 'LastName': 'Raz', 'Affiliation': 'Eleusis Benefit Corporation, New York, NY, USA.'}]",Psychopharmacology,['10.1007/s00213-019-05417-7']
2825,31805535,Subdivision of M1 Stage for De Novo Metastatic Breast Cancer to Better Predict Prognosis and Response to Primary Tumor Surgery.,"BACKGROUND


Patients with de novo metastatic breast cancer (MBC) constitute a heterogeneous group with different clinicopathologic characteristics and survival outcomes. Despite controversy regarding its prognostic value, primary tumor surgery may improve survival for selected patients.
PATIENTS AND METHODS


Patients with de novo MBC were identified using the SEER database and were then divided randomly into training and validation sets. A Fine-Gray competing risks model was developed to identify the variables associated with increased cancer-specific mortality in the training set. The M1 subdivision system was established based on the independent prognostic factors. Cumulative incidence curves were estimated and compared using Gray's test.
RESULTS


Involvement of brain or liver and number of metastatic sites were identified as independent prognostic factors in multivariate analysis. The M1 category was subdivided into 3 subcategories: M1a, single site involvement except brain and liver; M1b, liver involvement only, or multiple site involvement except brain and liver; and M1c, brain involvement regardless of number of metastatic sites, or liver and other sites involvement except brain (M1b vs M1a: subdistribution hazard ratio [SHR], 1.48; 95% CI, 1.29-1.68; M1c vs M1a: SHR, 2.45; 95% CI, 2.18-2.75). Patients with the M1a subtype benefited most from primary tumor surgery in the adjusted competing risks model (M1a: SHR, 0.57; 95% CI, 0.48-0.67, M1b: SHR, 0.62; 95% CI, 0.47-0.83, and M1c: SHR, 0.59; 95% CI, 0.44-0.80), whereas benefits conferred by treatment with chemotherapy alone increased with the upstaging of metastatic disease (M1a: SHR, 0.72; 95% CI, 0.62-0.83, M1b: SHR, 0.54; 95% CI, 0.44-0.68, and M1c: SHR, 0.53; 95% CI, 0.45-0.61).
CONCLUSIONS


Subdivision of M1 stage facilitates prognosis prediction and treatment planning for patients with de novo MBC. Treatment offered should be decided in a coordinated multidisciplinary setting. Primary tumor surgery may play an important role in the management of selected patients.",2019,"Patients with the M1a subtype benefited most from primary tumor surgery in the adjusted competing risks model (M1a: SHR, 0.57; 95% CI, 0.48-0.67, M1b: SHR, 0.62; 95% CI, 0.47-0.83, and M1c: SHR, 0.59; 95% CI, 0.44-0.80), whereas benefits conferred by treatment with chemotherapy alone increased with the upstaging of metastatic disease (M1a: SHR, 0.72; 95% CI, 0.62-0.83, M1b: SHR, 0.54; 95% CI, 0.44-0.68, and M1c: SHR, 0.53; 95% CI, 0.45-0.61).
","['Patients with de novo metastatic breast cancer (MBC', 'Patients with de novo MBC were identified using the SEER database', 'selected patients', 'patients with de novo MBC']",[],"['Cumulative incidence curves', 'survival', 'upstaging of metastatic disease', 'cancer-specific mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]",[],"[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0615811,"Patients with the M1a subtype benefited most from primary tumor surgery in the adjusted competing risks model (M1a: SHR, 0.57; 95% CI, 0.48-0.67, M1b: SHR, 0.62; 95% CI, 0.47-0.83, and M1c: SHR, 0.59; 95% CI, 0.44-0.80), whereas benefits conferred by treatment with chemotherapy alone increased with the upstaging of metastatic disease (M1a: SHR, 0.72; 95% CI, 0.62-0.83, M1b: SHR, 0.54; 95% CI, 0.44-0.68, and M1c: SHR, 0.53; 95% CI, 0.45-0.61).
","[{'ForeName': 'Caijin', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': 'Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, People’s Republic of China'}, {'ForeName': 'Jiayi', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, People’s Republic of China'}, {'ForeName': 'Shuning', 'Initials': 'S', 'LastName': 'Ding', 'Affiliation': 'Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, People’s Republic of China'}, {'ForeName': 'Chihwan', 'Initials': 'C', 'LastName': 'Goh', 'Affiliation': 'Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, People’s Republic of China'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Andriani', 'Affiliation': 'Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, People’s Republic of China'}, {'ForeName': 'Shuangshuang', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, People’s Republic of China'}, {'ForeName': 'Kunwei', 'Initials': 'K', 'LastName': 'Shen', 'Affiliation': 'Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, People’s Republic of China'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, People’s Republic of China'}]",Journal of the National Comprehensive Cancer Network : JNCCN,['10.6004/jnccn.2019.7332']
2826,31366417,Stress effects on cognitive function in patients with major depressive disorder: Does childhood trauma play a role?,"Impaired cognitive functioning constitutes an important symptom of major depressive disorder (MDD), potentially associated with elevated cortisol levels. Adverse childhood experiences (ACE) enhance the risk for MDD and can contribute to disturbances in the stress systems, including cortisol and cognitive functions. In healthy participants, cortisol administration as well as acute stress can affect cognitive performance. In the current study, we tested cognitive performance in MDD patients with (N = 32) and without (N = 52) ACE and healthy participants with (N = 22) and without (N = 37) ACE after psychosocial stress induction (Trier Social Stress Test, TSST) and a control condition (Placebo-TSST). MDD predicted lower performance in verbal learning and both selective and sustained attention, while ACE predicted lower performance in psychomotoric speed and working memory. There were no interaction effects of MDD and ACE. After stress, MDD patients were more likely to show lower performance in working memory as well as in selective and sustained attention compared with participants without MDD. Individuals with ACE were more likely to show lower performance in verbal memory after stress compared with individuals without ACE. Our results indicate negative effects of MDD and ACE on distinct cognitive domains. Furthermore, MDD and/or ACE seem to enhance susceptibility for stress-related cognitive impairments.",2020,"After stress, MDD patients were more likely to show lower performance in working memory as well as in selective and sustained attention compared with participants without MDD.","['patients with major depressive disorder', 'MDD patients with (N = 32) and without (N = 52', 'healthy participants', 'and healthy participants with (N = 22) and without (N = 37']","['control condition (Placebo-TSST', 'ACE']","['psychomotoric speed and working memory', 'verbal memory', 'cognitive function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",,0.0218758,"After stress, MDD patients were more likely to show lower performance in working memory as well as in selective and sustained attention compared with participants without MDD.","[{'ForeName': 'Linn K', 'Initials': 'LK', 'LastName': 'Kuehl', 'Affiliation': 'Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Berlin, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Schultebraucks', 'Affiliation': 'Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Berlin, Germany.'}, {'ForeName': 'Christian E', 'Initials': 'CE', 'LastName': 'Deuter', 'Affiliation': 'Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Berlin, Germany.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'May', 'Affiliation': 'Asklepios Fachklinikum Tiefenbrunn, Rosdorf, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Spitzer', 'Affiliation': 'Asklepios Fachklinikum Tiefenbrunn, Rosdorf, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Berlin, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wingenfeld', 'Affiliation': 'Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Berlin, Germany.'}]",Development and psychopathology,['10.1017/S0954579419000932']
2827,31642985,Effect of food-related behavioral activation therapy on food intake and the environmental impact of the diet: results from the MooDFOOD prevention trial.,"PURPOSE


Food-based dietary guidelines are proposed to not only improve diet quality, but to also reduce the environmental impact of diets. The aim of our study was to investigate whether food-related behavioral activation therapy (F-BA) applying Mediterranean-style dietary guidelines altered food intake and the environmental impact of the diet in overweight adults with subsyndromal symptoms of depression.
METHODS


In total 744 adults who either received the F-BA intervention (F-BA group) or no intervention (control group) for 12 months were included in this analysis. Food intake data were collected through a food frequency questionnaire at baseline and after 6 and 12 months. Greenhouse gas emissions (GHGE), land use (LU), and fossil energy use (FEU) estimates from life-cycle assessments and a weighted score of the three (pReCiPe score) were used to estimate the environmental impact of each individual diet at each timepoint.
RESULTS


The F-BA group reported increased intakes of vegetables (19.7 g/day; 95% CI 7.8-31.6), fruit (23.0 g/day; 9.4-36.6), fish (7.6 g/day; 4.6-10.6), pulses/legumes (4.0 g/day; 1.6-6.5) and whole grains (12.7 g/day; 8.0-17.5), and decreased intake of sweets/extras (- 6.8 g/day; - 10.9 to - 2.8) relative to control group. This effect on food intake resulted in no change in GHGE, LU, and pReCiPe score, but a relative increase in FEU by 1.6 MJ/day (0.8, 2.4).
CONCLUSIONS


A shift towards a healthier Mediterranean-style diet does not necessarily result in a diet with reduced environmental impact in a real-life setting.
TRIAL REGISTRATION


ClinicalTrials.gov. Number of identification: NCT02529423. August 2015.",2020,"The F-BA group reported increased intakes of vegetables (19.7 g/day; 95% CI 7.8-31.6), fruit (23.0 g/day; 9.4-36.6), fish (7.6 g/day; 4.6-10.6), pulses/legumes (4.0 g/day; 1.6-6.5) and whole grains (12.7 g/day; 8.0-17.5), and decreased intake of sweets/extras (- 6.8 g/day; - 10.9 to - 2.8) relative to control group.","['In total 744 adults who either received the', 'overweight adults with subsyndromal symptoms of depression']","['F-BA intervention (F-BA group) or no intervention (control group', 'food-related behavioral activation therapy (F-BA) applying Mediterranean-style dietary guidelines', 'food-related behavioral activation therapy']","['Greenhouse gas emissions (GHGE), land use (LU), and fossil energy use (FEU) estimates from life-cycle assessments and a weighted score of the three (pReCiPe score', 'intake of sweets/extras', 'FEU', 'intakes of vegetables', 'GHGE, LU, and pReCiPe score', 'diet quality']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C2733064', 'cui_str': 'Behavioral activation therapy (regime/therapy)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C3658297', 'cui_str': 'Nutrition Guidelines'}]","[{'cui': 'C4505224', 'cui_str': 'Greenhouse Gases'}, {'cui': 'C0233929', 'cui_str': 'Emission (finding)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0016614', 'cui_str': 'Fossils'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0023675', 'cui_str': 'Life Cycle'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",744.0,0.159008,"The F-BA group reported increased intakes of vegetables (19.7 g/day; 95% CI 7.8-31.6), fruit (23.0 g/day; 9.4-36.6), fish (7.6 g/day; 4.6-10.6), pulses/legumes (4.0 g/day; 1.6-6.5) and whole grains (12.7 g/day; 8.0-17.5), and decreased intake of sweets/extras (- 6.8 g/day; - 10.9 to - 2.8) relative to control group.","[{'ForeName': 'Alessandra C', 'Initials': 'AC', 'LastName': 'Grasso', 'Affiliation': 'Department of Health Sciences, Faculty of Science, and Amsterdam Public Health Research Institute, Vrije Universiteit (VU) Amsterdam, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands. alessandra.grasso@vu.nl.'}, {'ForeName': 'Margreet R', 'Initials': 'MR', 'LastName': 'Olthof', 'Affiliation': 'Department of Health Sciences, Faculty of Science, and Amsterdam Public Health Research Institute, Vrije Universiteit (VU) Amsterdam, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Corné', 'Initials': 'C', 'LastName': 'van Dooren', 'Affiliation': 'Netherlands Nutrition Centre (Voedingscentrum), Bezuidenhoutseweg 105, 2594 AC, The Hague, The Netherlands.'}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Roca', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut (IUNICS/IDISBA), Rediapp, University of Balearic Islands, Carretera De Valldemossa km 7.5, 07122, Palma de Mallorca, Spain.""}, {'ForeName': 'Margalida', 'Initials': 'M', 'LastName': 'Gili', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut (IUNICS/IDISBA), Rediapp, University of Balearic Islands, Carretera De Valldemossa km 7.5, 07122, Palma de Mallorca, Spain.""}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Visser', 'Affiliation': 'Department of Health Sciences, Faculty of Science, and Amsterdam Public Health Research Institute, Vrije Universiteit (VU) Amsterdam, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Mieke', 'Initials': 'M', 'LastName': 'Cabout', 'Affiliation': 'Department of Health Sciences, Faculty of Science, and Amsterdam Public Health Research Institute, Vrije Universiteit (VU) Amsterdam, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Mariska', 'Initials': 'M', 'LastName': 'Bot', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Research Institute, and GGZ inGeest Specialized Mental Health Care, Amsterdam UMC, VU Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Brenda W J H', 'Initials': 'BWJH', 'LastName': 'Penninx', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Research Institute, and GGZ inGeest Specialized Mental Health Care, Amsterdam UMC, VU Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'van Grootheest', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Research Institute, and GGZ inGeest Specialized Mental Health Care, Amsterdam UMC, VU Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Kohls', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, University Leipzig, Semmelweisstr. 10, Haus 13, 04103, Leipzig, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Hegerl', 'Affiliation': 'Department of Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty, Goethe-University Frankfurt, Heinrich-Hoffmann-Str. 10, 60528, Frankfurt a.M., Germany.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Owens', 'Affiliation': 'Department of Psychology, University of Exeter, Perry Road, Exeter, EX4 4QG, UK.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Watkins', 'Affiliation': 'Department of Psychology, University of Exeter, Perry Road, Exeter, EX4 4QG, UK.'}, {'ForeName': 'Ingeborg A', 'Initials': 'IA', 'LastName': 'Brouwer', 'Affiliation': 'Department of Health Sciences, Faculty of Science, and Amsterdam Public Health Research Institute, Vrije Universiteit (VU) Amsterdam, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of nutrition,['10.1007/s00394-019-02106-1']
2828,30890314,Barbed Versus Conventional Suture for Uterine Repair During Caesarean Section: A Randomized Controlled Study.,"OBJECTIVE


This study sought to compare the short-term outcome of uterine incision repair during a Caesarean section (CS) using a bidirectional knotless barbed suture versus polyglactin suture.
METHODS


A randomized controlled trial was conducted at a university hospital. Participants undergoing a CS were randomly assigned to uterine incision closure by bidirectional knotless barbed suture (group A) or polyglactin (group B). The primary outcome was the time needed to repair the uterine incision. The analysis was by intent to treat. A sample size of 35 per group (n = 70) was planned to detect a 30% reduction in uterine repair time (Canadian Task Force Classification I).
RESULTS


From July 2016 through October 2017, 150 women were screened, and 70 were statistically analyzed: group A (n = 35) and group B (n = 35). Time to complete uterine incision repair was 308 ± 57 seconds for group A and 411 ± 74 seconds for group B (P < 0.001). Total surgery time (33.4 ± 8.8 minutes vs. 33.2 ± 7.5 minutes; P = 0.64) was not significantly different between groups A and B, respectively.
CONCLUSION


Repair of the CS uterine incision with barbed suture compared with polyglactin suture reduces suturing time.",2019,Time to complete uterine incision repair was 308 ± 57 seconds for group A and 411 ± 74 seconds for group B (P< 0.001).,"['Participants undergoing a CS', 'During Caesarean Section', 'From July 2016 through October 2017, 150 women were screened, and 70 were statistically analyzed: group A (n\u202f=\u202f35) and group B (n\u202f=\u202f35']","['uterine incision closure by bidirectional knotless barbed suture (group A) or polyglactin', 'polyglactin suture', 'uterine incision repair during a Caesarean section (CS', 'bidirectional knotless barbed suture versus polyglactin suture', 'Barbed Versus Conventional Suture forUterine Repair', 'CS uterine incision with barbed suture']","['time needed to repair the uterine incision', 'uterine repair time (Canadian Task Force Classification I', 'Total surgery time', 'Time to complete uterine incision repair', 'suturing time']","[{'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}]","[{'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0032494', 'cui_str': 'Poly(Lactide-Co-Glycoside)'}, {'cui': 'C0183740', 'cui_str': 'Polyglactin suture'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0195379', 'cui_str': 'Repair of uterus (procedure)'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0162458', 'cui_str': 'Task Forces'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}]",150.0,0.337964,Time to complete uterine incision repair was 308 ± 57 seconds for group A and 411 ± 74 seconds for group B (P< 0.001).,"[{'ForeName': 'Leonti', 'Initials': 'L', 'LastName': 'Grin', 'Affiliation': 'Department of Obstetrics and Gynecology, Barzilai University Medical Center, Faculty of Health Sciences, Ben-Gurion University of Negev, Ashkelon, Israel.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Namazov', 'Affiliation': 'Department of Obstetrics and Gynecology, Barzilai University Medical Center, Faculty of Health Sciences, Ben-Gurion University of Negev, Ashkelon, Israel. Electronic address: enamazov@gmail.com.'}, {'ForeName': 'Ale', 'Initials': 'A', 'LastName': 'Ivshin', 'Affiliation': 'Department of Obstetrics and Gynecology, Barzilai University Medical Center, Faculty of Health Sciences, Ben-Gurion University of Negev, Ashkelon, Israel.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Rabinovich', 'Affiliation': 'Department of Obstetrics and Gynecology, Barzilai University Medical Center, Faculty of Health Sciences, Ben-Gurion University of Negev, Ashkelon, Israel.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Shochat', 'Affiliation': 'Department of Obstetrics and Gynecology, Barzilai University Medical Center, Faculty of Health Sciences, Ben-Gurion University of Negev, Ashkelon, Israel.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Shenhav', 'Affiliation': 'Department of Obstetrics and Gynecology, Barzilai University Medical Center, Faculty of Health Sciences, Ben-Gurion University of Negev, Ashkelon, Israel.'}, {'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Gemer', 'Affiliation': 'Department of Obstetrics and Gynecology, Barzilai University Medical Center, Faculty of Health Sciences, Ben-Gurion University of Negev, Ashkelon, Israel.'}, {'ForeName': 'Efraim', 'Initials': 'E', 'LastName': 'Zohav', 'Affiliation': 'Department of Obstetrics and Gynecology, Barzilai University Medical Center, Faculty of Health Sciences, Ben-Gurion University of Negev, Ashkelon, Israel.'}, {'ForeName': 'Eyal Y', 'Initials': 'EY', 'LastName': 'Anteby', 'Affiliation': 'Department of Obstetrics and Gynecology, Barzilai University Medical Center, Faculty of Health Sciences, Ben-Gurion University of Negev, Ashkelon, Israel.'}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2019.01.011']
2829,32095914,Social and Economic Equity and Family Cohesion as Potential Protective Factors from Depression Among Adolescents Living with HIV in Uganda.,"Adolescents living with HIV in Uganda are impacted by poverty and face a number of health and social challenges including access to medication, health complications, and social stigma. These stressors have been linked to depression, which can lead to lower HIV treatment adherence. This study seeks to determine how social and economic equity, family cohesion, and social supports may be related to depression among adolescents living with HIV. We used baseline data from the Suubi + Adherence study, a 5-year longitudinal randomized controlled trial among adolescents living with HIV in southwestern Uganda (n = 675; ages 10-16 years). Hierarchical logistic regression models were conducted separately among in-school adolescents and out-of-school adolescents to assess the hypothesized associations between economic and social equity, social support, and depression. About half of the participants meet the criteria for depression. Adolescents with depression were found to have fewer economic and social supports. Our findings indicate that social and economic equity [odds ratio (OR) = 0.85, 95% confidence interval (CI) 0.74, 0.99], family cohesion (OR = 0.94, 95% CI 0.91-0.96), and social support from friends (OR = 0.95, 95% CI 0.91-0.998) are associated with depression for in-school HIV infected adolescents and could be protective factors. The results of this study suggest that social and economic equity may play a protective role against depression and other poor mental health outcomes. Potential interventions for adolescents living with HIV should consider these social and familial factors as they may be protective of depression in this population.",2020,"Our findings indicate that social and economic equity [odds ratio (OR) = 0.85, 95% confidence interval (CI) 0.74, 0.99], family cohesion (OR = 0.94, 95% CI 0.91-0.96), and social support from friends (OR = 0.95, 95% CI 0.91-0.998) are associated with depression for in-school HIV infected adolescents and could be protective factors.","['Adolescents living with HIV in Uganda', 'school adolescents and out-of-school adolescents', 'Adolescents Living with HIV in Uganda', 'adolescents living with HIV in southwestern Uganda (n\u2009=\u2009675; ages 10-16\xa0years', 'Adolescents with depression', 'adolescents living with HIV']",[],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4517854', 'cui_str': '675 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",[],[],,0.0413364,"Our findings indicate that social and economic equity [odds ratio (OR) = 0.85, 95% confidence interval (CI) 0.74, 0.99], family cohesion (OR = 0.94, 95% CI 0.91-0.96), and social support from friends (OR = 0.95, 95% CI 0.91-0.998) are associated with depression for in-school HIV infected adolescents and could be protective factors.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Cavazos-Rehg', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, 660 South Euclid Avenue, Box 8134, St. Louis, MO, 63110, USA. pcavazos@wustl.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, 660 South Euclid Avenue, Box 8134, St. Louis, MO, 63110, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Kasson', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, 660 South Euclid Avenue, Box 8134, St. Louis, MO, 63110, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Byansi', 'Affiliation': 'Brown School, Washington University in St. Louis, One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Ozge Sensoy', 'Initials': 'OS', 'LastName': 'Bahar', 'Affiliation': 'Brown School, Washington University in St. Louis, One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'Brown School, Washington University in St. Louis, One Brookings Drive, St. Louis, MO, 63130, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02812-6']
2830,31729895,"The Influence of Sexual Arousal on Self-Reported Sexual Willingness and Automatic Approach to Models of Low, Medium, and High Prior Attractiveness.","Anecdotal evidence suggests that sexual attraction is flexible, and that high levels of sexual arousal can promote sexual willingness and approach tendencies toward a priori low attractive mates. This experimental study tested whether heightened sexual arousal can lower the threshold for sexual willingness and automatic approach tendencies toward potential sex partners of low and medium attractiveness. Heterosexual male ( n = 54) and female ( n = 61) participants were randomly assigned to a sexual arousal or control condition. Approach tendencies were indexed using a reaction time task. Sexual willingness was indexed using participant ratings of willingness to kiss and to consider having sex with same- and other-sex models of low, medium, and high attractiveness. Overall, participants showed stronger approach to models of high and medium than of low attractiveness. Sexual arousal weakened this differential responding but did not result in a robust increase of approach toward less attractive other-sex or same-sex models. Sexual willingness toward less attractive models was not affected by sexual arousal. Independent of condition, women reported greater sexual willingness toward same-sex models. The current pattern of findings does not support the notion that sexual arousal promotes automatic approach and sexual willingness to a broader array of sex partners.",2020,Sexual arousal weakened this differential responding but did not result in a robust increase of approach toward less attractive other-sex or same-sex models.,['Heterosexual male ( n = 54) and female ( n = 61'],['sexual arousal or control condition'],"['Sexual willingness', 'sexual willingness', 'Sexual arousal']","[{'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0233972', 'cui_str': 'Sexual excitation, function (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0233972', 'cui_str': 'Sexual excitation, function (observable entity)'}]",,0.018785,Sexual arousal weakened this differential responding but did not result in a robust increase of approach toward less attractive other-sex or same-sex models.,"[{'ForeName': 'Charmaine', 'Initials': 'C', 'LastName': 'Borg', 'Affiliation': 'Department of Clinical Psychology & Experimental Psychopathology, University of Groningen.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Pawłowska', 'Affiliation': 'Department of Clinical Psychology & Experimental Psychopathology, University of Groningen.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'van Stokkum', 'Affiliation': 'Department of Clinical Psychology & Experimental Psychopathology, University of Groningen.'}, {'ForeName': 'Janniko R', 'Initials': 'JR', 'LastName': 'Georgiadis', 'Affiliation': 'Department of Biomedical Sciences of Cells & Systems / Section Anatomy & Medical Physiology, University of Groningen, University Medical Center Groningen.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'de Jong', 'Affiliation': 'Department of Clinical Psychology & Experimental Psychopathology, University of Groningen.'}]",Journal of sex research,['10.1080/00224499.2019.1687641']
2831,31892680,Effect of an Anesthetic Chewing Gum on the Initial Pain or Discomfort from Orthodontic Elastomeric Separator Placement.,"AIM


The aim of this study was to investigate the effect of a formulated anesthetic chewing gum (ACG) on the initial pain/discomfort resulting from the placement of orthodontic separators.
MATERIALS AND METHODS


The preparation of ACG formulation was investigated using food and drug administration (FDA)-certified ingredients. Sixty subjects were recruited and randomly allocated to three groups: (1) ACG, (2) chewing gum (CG) without anesthetics or (3) control (no CG) group. All subjects received an orthodontic elastomeric separator that was placed between the maxillary right or left first molar and second premolar. For all groups, the registration of pain/discomfort experienced immediately after separator placement (0 hour), then after 1, 4, and 8 hours was carried out using the visual analog scale.
RESULTS


Regarding the pain/discomfort perception, there was a statistically significant difference ( p  value <0.0001) between the three groups (ACG, CG, and controls) at each of the three-time points (1, 4 and 8 hours). There were no harms reported by both groups except for temporary mild muscle soreness from gum chewing that was reported by four subjects from the ACG group and two subjects from the CG group.
CONCLUSION


The ACG can significantly decrease and eliminate the initial pain/discomfort resulting from the placement of the orthodontic elastomeric separators. Furthermore, the ACG may decrease the need for a systemic analgesic.
CLINICAL SIGNIFICANCE


Orthodontic elastomeric separator placement can be uncomfortable. The ACG significantly decreased the initial pain/discomfort from orthodontic separators during the 8 hours. Therefore, the ACG can be used by the patients as needed whenever pain/discomfort is experienced from the placement of elastomeric separators. Consequently, this may reduce the need for systemic analgesics. How to cite this article: Al-Melh MA, Nada A, Badr H,  et al.  Effect of an Anesthetic Chewing Gum on the Initial Pain or Discomfort from Orthodontic Elastomeric Separator Placement. J Contemp Dent Pract 2019;20(11):1286-1292.",2019,"There were no harms reported by both groups except for temporary mild muscle soreness from gum chewing that was reported by four subjects from the ACG group and two subjects from the CG group.
",['Sixty subjects'],"['ACG, (2) chewing gum (CG) without anesthetics or (3) control (no CG', 'orthodontic elastomeric separator', 'anesthetic chewing gum (ACG', 'Anesthetic Chewing Gum']","['temporary mild muscle soreness', 'Initial Pain or Discomfort', 'pain/discomfort perception', 'initial pain/discomfort']",[],"[{'cui': 'C0050397', 'cui_str': 'insulin potentiating fragments of growth hormone'}, {'cui': 'C4321298', 'cui_str': 'Chewing gum'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0444925', 'cui_str': 'elastomeric'}]","[{'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",60.0,0.0316654,"There were no harms reported by both groups except for temporary mild muscle soreness from gum chewing that was reported by four subjects from the ACG group and two subjects from the CG group.
","[{'ForeName': 'Manal A', 'Initials': 'MA', 'LastName': 'Al-Melh', 'Affiliation': 'Department of Developmental and Preventive Sciences, Faculty of Dentistry, Health Sciences Center, Kuwait University, Kuwait City, Kuwait, Phone: +965 24636709, e-mail: mabualmelh@hsc.edu.kw.'}, {'ForeName': 'Aly', 'Initials': 'A', 'LastName': 'Nada', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Health Sciences Center, Kuwait University, Kuwait City, Kuwait.'}, {'ForeName': 'Hanan', 'Initials': 'H', 'LastName': 'Badr', 'Affiliation': 'Department of Community Medicine and Behavioral Sciences, Faculty of Medicine, Health Sciences Center, Kuwait University, Kuwait City, Kuwait.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Andersson', 'Affiliation': 'Department of Surgical Sciences, Faculty of Dentistry, Health Sciences Center, Kuwait University, Kuwait City, Kuwait.'}]",The journal of contemporary dental practice,[]
2832,30689671,Community-level chlamydial serology for assessing trachoma elimination in trachoma-endemic Niger.,"BACKGROUND


Program decision-making for trachoma elimination currently relies on conjunctival clinical signs. Antibody tests may provide additional information on the epidemiology of trachoma, particularly in regions where it is disappearing or elimination targets have been met.
METHODS


A cluster-randomized trial of mass azithromycin distribution strategies for trachoma elimination was conducted over three years in a mesoendemic region of Niger. Dried blood spots were collected from a random sample of children aged 1-5 years in each of 24 study communities at 36 months after initiation of the intervention. A multiplex bead assay was used to test for antibodies to two Chlamydia trachomatis antigens, Pgp3 and CT694. We compared seropositivity to either antigen to clinical signs of active trachoma (trachomatous inflammation-follicular [TF] and trachomatous inflammation-intense [TI]) at the individual and cluster level, and to ocular chlamydia prevalence at the community level.
RESULTS


Of 988 children with antibody data, TF prevalence was 7.8% (95% CI 6.1 to 9.5) and TI prevalence was 1.6% (95% CI 0.9 to 2.6). The overall prevalence of antibody positivity to Pgp3 was 27.2% (95% CI 24.5 to 30), and to CT694 was 23.7% (95% CI 21 to 26.2). Ocular chlamydia infection prevalence was 5.2% (95% CI 2.8 to 7.6). Seropositivity to Pgp3 and/or CT694 was significantly associated with TF at the individual and community level and with ocular chlamydia infection and TI at the community level. Older children were more likely to be seropositive than younger children.
CONCLUSION


Seropositivity to Pgp3 and CT694 correlates with clinical signs and ocular chlamydia infection in a mesoendemic region of Niger.
TRIAL REGISTRATION


ClinicalTrials.gov NCT00792922.",2019,Seropositivity to Pgp3,"['trachoma elimination was conducted over three years in a mesoendemic region of Niger', '988 children with antibody data', 'trachoma-endemic Niger', 'Older children']","['Pgp3', 'azithromycin', 'Community-level chlamydial serology']","['TF prevalence', 'TI prevalence', 'Dried blood spots', 'overall prevalence of antibody positivity to Pgp3', 'Ocular chlamydia infection prevalence']","[{'cui': 'C0040592', 'cui_str': 'Egyptian Ophthalmia'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0028074', 'cui_str': 'Republic of Niger'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036745', 'cui_str': 'Serology'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0008149', 'cui_str': 'Chlamydia Infections'}]",988.0,0.0579997,Seropositivity to Pgp3,"[{'ForeName': 'Jessica S', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'F. I. Proctor Foundation, University of California San Francisco, San Francisco, California, United States of America.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'F. I. Proctor Foundation, University of California San Francisco, San Francisco, California, United States of America.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Cooley', 'Affiliation': 'Divison of Parasitic Diseases and Malaria, Centers for Disease Prevention and Control, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Abdou', 'Initials': 'A', 'LastName': 'Amza', 'Affiliation': 'Programme FSS/Université Abdou Moumouni de Niamey, Programme Nationale des Soins Oculaire, Niger.'}, {'ForeName': 'Boubacar', 'Initials': 'B', 'LastName': 'Kadri', 'Affiliation': 'Programme FSS/Université Abdou Moumouni de Niamey, Programme Nationale des Soins Oculaire, Niger.'}, {'ForeName': 'Baido', 'Initials': 'B', 'LastName': 'Nassirou', 'Affiliation': 'Programme FSS/Université Abdou Moumouni de Niamey, Programme Nationale des Soins Oculaire, Niger.'}, {'ForeName': 'Sun Yu', 'Initials': 'SY', 'LastName': 'Cotter', 'Affiliation': 'F. I. Proctor Foundation, University of California San Francisco, San Francisco, California, United States of America.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Stoller', 'Affiliation': 'F. I. Proctor Foundation, University of California San Francisco, San Francisco, California, United States of America.'}, {'ForeName': 'Sheila K', 'Initials': 'SK', 'LastName': 'West', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'Clinical Research Unit, Department of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'F. I. Proctor Foundation, University of California San Francisco, San Francisco, California, United States of America.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Gaynor', 'Affiliation': 'F. I. Proctor Foundation, University of California San Francisco, San Francisco, California, United States of America.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'F. I. Proctor Foundation, University of California San Francisco, San Francisco, California, United States of America.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'F. I. Proctor Foundation, University of California San Francisco, San Francisco, California, United States of America.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Martin', 'Affiliation': 'Divison of Parasitic Diseases and Malaria, Centers for Disease Prevention and Control, Atlanta, Georgia, United States of America.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0007127']
2833,31682466,Comparing psoriasis advertisement methods with patient willingness to initiate treatment.,"Background:  Many patients with psoriasis struggle with taking biologic agents. The way in which providers present medications could enhance treatment adherence. Objectives:  To determine how fear appeals, personal appeals, and social appeals influence psoriasis patients' willingness to use a biologic. Methods:  A randomized online survey study was used to assess subjects with a self-reported diagnosis of psoriasis and their willingness to initiate treatment. Subjects were randomized in a 1:1:1 ratio to receive an online survey with the following emotional appeals: social, fear, or personal ( n  = 315). Subject-reported willingness to take treatment was recorded on a 10-point Likert scale and analyzed via single-factor ANOVA, two-group t-tests, chi-squared analysis, and multiple linear regression analysis. Results:  A total of 315 subjects with a reported diagnosis of psoriasis completed the survey. Patient demographic information includes the following: mean age of 35 years ± 11.2; 67% female. Compared to subjects presented with a social appeal ( M  = 6.2, SD = 2.9), subjects presented with a fear appeal ( M  = 7.1, SD = 2.5,  p  = .01) and personal appeal ( M  = 7.0, SD = 2.7,  p  = .03) reported a greater average willingness to take treatment. Conclusions:  Presenting biologic agents using fear or personal appeals may be a simple and effective technique to improve patients' willingness to take treatment.",2020,"Compared to subjects presented with a social appeal (M = 6.2, SD =2.9), subjects presented with a fear appeal (M = 7.1, SD =2.5, p = 0.01) and personal appeal (M = 7.0, SD =2.7, p = 0.03) reported a greater average willingness to take treatment.","['315 subjects with a reported diagnosis of psoriasis completed the survey', ' mean age of 35 years ±11.2; 67% female', 'subjects with a self-reported diagnosis of psoriasis and their willingness to initiate treatment', 'patients with psoriasis struggle with taking biologic agents']","['online survey with the following emotional appeals: social, fear, or personal', ' ']",[],"[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0005515', 'cui_str': 'Biological Agents'}]","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",[],315.0,0.0190185,"Compared to subjects presented with a social appeal (M = 6.2, SD =2.9), subjects presented with a fear appeal (M = 7.1, SD =2.5, p = 0.01) and personal appeal (M = 7.0, SD =2.7, p = 0.03) reported a greater average willingness to take treatment.","[{'ForeName': 'Jeremy K', 'Initials': 'JK', 'LastName': 'Bray', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Cline', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Masicampo', 'Affiliation': 'Department of Psychology, Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Kammrath', 'Affiliation': 'Department of Psychology, Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Feldman', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}]",The Journal of dermatological treatment,['10.1080/09546634.2019.1688235']
2834,30870576,Effects of Intravenous Zoledronate on Bone Turnover and Bone Density Persist for at Least 11 Years in HIV-Infected Men.,"Previously we reported the results of a 4-year extension of a 2-year randomized placebo-controlled trial showing that the antiresorptive effects of two annual 4-mg doses of zoledronate in HIV-infected men persisted for at least 5 years after the second dose. We set out to determine whether the effects on BMD and bone turnover persist beyond 10 years. We invited all participants in the original trial known to be alive and living in New Zealand to attend an additional visit approximately 12 years after trial entry and 11 years after their second dose of study medication. The outcome measures were BMD at the lumbar spine, proximal femur, and total body, and markers of bone turnover. Twenty-five of the 43 men originally enrolled in the trial attended the final visit, representing 25 of 31 (81%) participants alive and residing in New Zealand at the time. The average duration of follow-up was 12.4 years. At the final visit, BMD remained higher in the zoledronate group than the placebo group (lumbar spine 3.7%, 95% CI, 0.1 to 7.3; total hip 3.7%, 95% CI, 1.2 to 6.2; femoral neck 5.0%, 95% CI, 2.1 to 7.9; total body 2.4%, 95% CI, 0.7 to 4.0), and the between-group differences in BMD remained stable between 6 and 12 years. Serum CTx remained lower in the zoledronate group than the placebo group between 6 and 12 years and, at the final visit, was 45% lower (95% CI, 25 to 64) than the placebo group. P1NP was 26% (95% CI, 4 to 48) lower in the zoledronate group than the placebo group at the final visit. In summary, two annual 4-mg doses of zoledronate have effects on bone turnover and BMD in men that persist for at least 11 years after the second dose. © 2019 American Society for Bone and Mineral Research.",2019,"P1NP was 26% (95% CI, 4 to 48) lower in the zoledronate group than the placebo group at the final visit.","['Twenty-five of the 43 men originally enrolled in the trial attended the final visit, representing 25 of 31 (81%) participants alive and residing in New Zealand at the time', 'for at Least 11 Years in HIV-Infected Men', 'participants in the original trial known to be alive and living in New Zealand to attend an additional visit approximately 12 years after trial entry and 11 years after their second dose of study medication', 'HIV-infected men persisted for at least 5 years after the second dose']","['Intravenous Zoledronate', 'zoledronate', 'placebo']","['P1NP', 'Serum CTx', 'BMD', 'Bone Turnover and Bone Density Persist', 'BMD at the lumbar spine, proximal femur, and total body, and markers of bone turnover', 'bone turnover and BMD']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0392938', 'cui_str': 'Zoledronate (substance)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.172185,"P1NP was 26% (95% CI, 4 to 48) lower in the zoledronate group than the placebo group at the final visit.","[{'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Bolland', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Horne', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Simon E', 'Initials': 'SE', 'LastName': 'Briggs', 'Affiliation': 'Department of Infectious Diseases, Auckland Hospital, Auckland, New Zealand.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Thomas', 'Affiliation': 'Department of Infectious Diseases, Auckland Hospital, Auckland, New Zealand.'}, {'ForeName': 'IanR', 'Initials': 'I', 'LastName': 'Reid', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Greg D', 'Initials': 'GD', 'LastName': 'Gamble', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Grey', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland, New Zealand.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3712']
2835,31887277,Magnetic Resonance-Based Diagnostics for Bleeding Assessment in Neonatal Cardiac Surgery.,"PURPOSE


Infants undergoing a cardiac operation are at high risk for postsurgical bleeding. To date, there are no highly predictive models for postsurgical bleeding in this population. This study's objective was to assess the predictive ability of T2 magnetic resonance (T2MR).
DESCRIPTION


T2MR uses magnetic resonance to detect clot formation characteristics on a small blood sample and provides hemostatic indicators that can assess bleeding risk.
EVALUATION


This prospective, single-institution study enrolled 100 patients younger than 12 months old undergoing a cardiac operation from April 27, 2015, to September 21, 2016. The primary end point was postsurgical bleeding within 24 hours after the procedure. T2MR data were modeled with a binary recursive partitioning algorithm with randomized cross-validation. The tight clot metric produced the highest univariate discrimination of bleeding (receiver operator characteristic curve, 0.64; classification accuracy, 72%), and along with the platelet function metric, demonstrated highest relative importance based on Gini index splitting (Salford Systems, San Diego, CA). Multivariate modeling with cross-validation showed mean receiver operator characteristic curve area of 0.74 and classification accuracy of 82%.
CONCLUSIONS


T2MR tight clot and platelet function metrics were associated with bleeding events.",2020,"The tight clot metric produced the highest univariate discrimination of bleeding (receiver operator curve = 0.64, classification accuracy = 72%), and along with the platelet function metric, demonstrated highest relative importance based on Gini index splitting.","['Infants undergoing cardiac surgery', '100 patients less than 12 months old undergoing cardiac surgery from 4/27/2015 and 9/21/2016', 'Neonatal Cardiac Surgery']","['Magnetic Resonance-Based Diagnostics', 'T2 magnetic resonance (T2MR']",['post-surgical bleeding'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}]","[{'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",100.0,0.0527928,"The tight clot metric produced the highest univariate discrimination of bleeding (receiver operator curve = 0.64, classification accuracy = 72%), and along with the platelet function metric, demonstrated highest relative importance based on Gini index splitting.","[{'ForeName': 'Perry S', 'Initials': 'PS', 'LastName': 'Choi', 'Affiliation': ""Department of Cardiovascular Surgery, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Sirisha', 'Initials': 'S', 'LastName': 'Emani', 'Affiliation': ""Department of Cardiovascular Surgery, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Ibla', 'Affiliation': ""Department of Anesthesiology, Critical Care, and Pain Medicine, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Marturano', 'Affiliation': 'T2 Biosystems, Lexington, Massachusetts.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Lowery', 'Affiliation': 'T2 Biosystems, Lexington, Massachusetts.'}, {'ForeName': 'Sitaram', 'Initials': 'S', 'LastName': 'Emani', 'Affiliation': ""Department of Cardiovascular Surgery, Boston Children's Hospital, Boston, Massachusetts. Electronic address: sitaram.emani@cardio.chboston.org.""}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2019.11.010']
2836,31713723,"Ubiquinol Improves Endothelial Function in Patients with Heart Failure with Reduced Ejection Fraction: A Single-Center, Randomized Double-Blind Placebo-Controlled Crossover Pilot Study.","BACKGROUND


Endothelial dysfunction is reportedly associated with worse outcomes in patients with chronic heart failure. Ubiquinol is a reduced form of coenzyme Q10 (CoQ10) that may improve endothelial function.
OBJECTIVE


We assessed the hypothesis that ubiquinol improves peripheral endothelial function in patients with heart failure with reduced ejection fraction (HFrEF).
METHODS


In this randomized, double-blind, placebo-controlled, crossover pilot study, 14 patients with stable HFrEF were randomly and blindly allocated to ubiquinol 400 mg/day or placebo for 3 months. After a 1-month washout period, patients were crossed over to the alternative treatment. Before and after each treatment, we assessed peripheral endothelial function using the reactive hyperemia index (RHI) and analyzed it using the natural logarithm of RHI (LnRHI).
RESULTS


Peripheral endothelial function as assessed by LnRHI tended to improve with ubiquinol 400 mg/day for 3 months (p = 0.076). Original RHI values were also compared, and RHI significantly improved with ubiquinol treatment (pre-RHI 1.57 [interquartile range (IQR) 1.39-1.80], post-RHI 1.74 [IQR 1.63-2.02], p = 0.026), but not with placebo (pre-RHI 1.67 [IQR 1.53-1.85], post-RHI 1.51 [IQR 1.39-2.11], p = 0.198).
CONCLUSIONS


Ubiquinol 400 mg/day for 3 months led to significant improvement in peripheral endothelial function in patients with HFrEF. Ubiquinol may be a therapeutic option for individuals with HFrEF. Large-scale randomized controlled trials of CoQ10 supplementation in patients with HFrEF are needed.
CLINICAL TRIAL REGISTRATION


Japanese University Hospital Medical Information Network (UMIN-ICDR). Clinical Trial identifier number UMIN000012604.",2020,"RESULTS


Peripheral endothelial function as assessed by LnRHI tended to improve with ubiquinol 400 mg/day for 3 months (p = 0.076).","['patients with HFrEF are needed', 'patients with heart failure with reduced ejection fraction (HFrEF', 'individuals with HFrEF', 'Patients with Heart Failure with Reduced Ejection Fraction', 'patients with chronic heart failure', 'patients with HFrEF', '14 patients with stable HFrEF']","['Placebo', 'Ubiquinol', 'CoQ10 supplementation', 'ubiquinol 400\xa0mg/day or placebo', 'placebo']","['peripheral endothelial function', 'Peripheral endothelial function', 'Original RHI values', 'peripheral endothelial function using the reactive hyperemia index (RHI) and analyzed it using the natural logarithm of RHI (LnRHI', 'Endothelial Function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0950189', 'cui_str': 'ubiquinols'}, {'cui': 'C0056077', 'cui_str': 'coenzyme Q10'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.587128,"RESULTS


Peripheral endothelial function as assessed by LnRHI tended to improve with ubiquinol 400 mg/day for 3 months (p = 0.076).","[{'ForeName': 'Chika', 'Initials': 'C', 'LastName': 'Kawashima', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Matsuzawa', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan. matsu@yokohama-cu.ac.jp.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Konishi', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Akiyama', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Sato', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan.'}, {'ForeName': 'Hidefumi', 'Initials': 'H', 'LastName': 'Nakahashi', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan.'}, {'ForeName': 'Shinnosuke', 'Initials': 'S', 'LastName': 'Kikuchi', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Kimura', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Maejima', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Iwahashi', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Hibi', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Kosuge', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Ebina', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan.'}, {'ForeName': 'Kouichi', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan.'}]","American journal of cardiovascular drugs : drugs, devices, and other interventions",['10.1007/s40256-019-00384-y']
2837,31789303,Comprehensive nursing based on feedforward control and postoperative FMA and SF-36 levels in femoral intertrochanteric fracture.,"OBJECTIVE


To study the effect of comprehensive nursing based on the concept of feedforward control on postoperative FMA (Fugl-Meyer Assessment) and SF-36 (health status questionnaire) in patients with femoral trochanteric fracture.
METHODS


114 patients with femoral intertrochanteric fracture were enrolled in the study. Patients were divided into control group and observation group according to order of admission, 57 cases in each group. Both groups of patients received proximal femoral nail antirotation surgery, conventional nursing and feedforward control based comprehensive nursing. Nursing effects of the two groups of patients were compared.
RESULTS


Anus first exhaust time, the time of getting out of bed and hospitalization time, and after nursing, SAS (Self-Rating Anxiety) and SDS (Self-Rating Depression) score of the observation group were significantly lower than those of the control group ( p <0.05). FMA and SF-36 score of the observation group after surgical nursing were significantly higher than those of the control group ( p <0.05). The total incidence of complications in the observation group was lower than that in the control group ( p <0.05).
CONCLUSIONS


Comprehensive care based on the concept of feedforward control has a better nursing effect for patients with intertrochanteric fracture, which can shorten the time of patient getting out of bed and hospitalization and reduce the incidence of post-complications.",2019,FMA and SF-36 score of the observation group after surgical nursing were significantly higher than those of the control group ( p <0.05).,"['114 patients with femoral intertrochanteric fracture were enrolled in the study', 'femoral intertrochanteric fracture', 'patients with femoral trochanteric fracture', 'patients with intertrochanteric fracture']","['proximal femoral nail antirotation surgery, conventional nursing and feedforward control based comprehensive nursing']","['total incidence of complications', 'FMA and SF-36 score', 'postoperative FMA (Fugl-Meyer Assessment) and SF-36 (health status questionnaire', 'time of getting out of bed and hospitalization time, and after nursing, SAS (Self-Rating Anxiety) and SDS (Self-Rating Depression) score']","[{'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0162385', 'cui_str': 'Intertrochanteric Fractures'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0162387', 'cui_str': 'Trochanteric Fractures'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",114.0,0.0128474,FMA and SF-36 score of the observation group after surgical nursing were significantly higher than those of the control group ( p <0.05).,"[{'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Fan', 'Affiliation': 'Department of Orthopaedics (II), The Third Affiliated Hospital of Qiqihar Medical University, P. R. China.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': 'Division of Pain Management, The Second Affiliated Hospital of Harbin Medical University, P. R. China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Qu', 'Affiliation': 'Department of Proctology, The Third Affiliated Hospital of Qiqihar Medical University, P. R. China.'}, {'ForeName': 'Shaohua', 'Initials': 'S', 'LastName': 'Tian', 'Affiliation': 'Department of Orthopaedics (II), The Third Affiliated Hospital of Qiqihar Medical University, P. R. China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedics (II), The Third Affiliated Hospital of Qiqihar Medical University, P. R. China.'}, {'ForeName': 'Wenlong', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedics (II), The Third Affiliated Hospital of Qiqihar Medical University, P. R. China.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopaedics (II), The Third Affiliated Hospital of Qiqihar Medical University, P. R. China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'Department of Orthopaedics (II), The Third Affiliated Hospital of Qiqihar Medical University, P. R. China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Personnel Office, The Third Affiliated Hospital of Qiqihar Medical University, P. R. China.'}]",Journal of musculoskeletal & neuronal interactions,[]
2838,31063434,Consumption of  Moringa oleifera  Lam Leaves Lowers Postprandial Blood Pressure.,"Objective:  This clinical study monitored the effect of eating cooked  Moringa oleifera  leaves on the blood pressure (BP) of healthy participants in view of the perception that consumption of Moringa is associated with an increase in blood pressure, which is contradictory to the findings from the literature. Methods:  A random sample of 41 healthy participants were enrolled in this prospective, placebo-controlled clinical study. Participants in the case study consumed 120 g of cooked  M. oleifera  leaves while the control group did not eat Moringa leaves. BP was measured at baseline before the meal and followed up at regular intervals over 24 hours for both groups. Baseline (T0) mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) and postprandial follow-up (T2-T24) were measured for both groups. Participants recorded their diet for a week and this led to an estimation of the total salt consumption per day. Results:  A significant difference was observed between DBP at baseline and two hours postprandial (T2) for the case group ( p  = 0.013). Moreover, in the case group, despite high consumption of salt (7 g/d) during the week preceding the clinical study, there was a significant decrease in both the SBP and DBP. In the control group, participants with prior high consumption of salt (7 g/d) during the week had elevated SBP and DBP. Conclusions:  These findings in human subjects indicated the lowering effect of  Moringa oleifera  leaves consumption on the 2 hours postprandial BP and showed a potential lowering effect on both SBP and DBP despite prior high consumption of salt (7 g/d).",2020,A significant difference was observed between DBP at baseline and two hours postprandial (T2) for the case group (p = 0.013).,"['healthy participants', '41 healthy participants']","['eating cooked Moringa oleifera leaves', 'placebo']","['blood pressure', 'DBP', 'SBP and DBP', 'Postprandial Blood Pressure', 'BP', 'eat Moringa leaves', 'Baseline (T0) mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) and postprandial follow-up (T2-T24', 'blood pressure (BP', 'elevated SBP and DBP']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C1306756', 'cui_str': 'Cook (occupation)'}, {'cui': 'C0949952', 'cui_str': 'Drumsticktree'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0969724', 'cui_str': 'Moringa'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",41.0,0.0183729,A significant difference was observed between DBP at baseline and two hours postprandial (T2) for the case group (p = 0.013).,"[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Chan Sun', 'Affiliation': 'Department of Medicine, Faculty of Science, University of Mauritius, Reduit, Republic of Mauritius.'}, {'ForeName': 'Zaina B', 'Initials': 'ZB', 'LastName': 'Ruhomally', 'Affiliation': 'Department of Health Sciences and ANDI Centre of Excellence for Biomedical and Biomaterials Research, Faculty of Science, University of Mauritius, Reduit, Republic of Mauritius.'}, {'ForeName': 'Ravindra', 'Initials': 'R', 'LastName': 'Boojhawon', 'Affiliation': 'Department of Mathematics, Faculty of Science, University of Mauritius, Reduit, Republic of Mauritius.'}, {'ForeName': 'Vidushi S', 'Initials': 'VS', 'LastName': 'Neergheen-Bhujun', 'Affiliation': 'Department of Health Sciences and ANDI Centre of Excellence for Biomedical and Biomaterials Research, Faculty of Science, University of Mauritius, Reduit, Republic of Mauritius.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2019.1608602']
2839,31942818,Intensive Unimanual Training Leads to Better Reaching and Head Control than Bimanual Training in Children with Unilateral Cerebral Palsy.,"AIMS


To quantify the changes in joint movement control and motor planning of the more-affected upper extremity (UE) during a reach-grasp-eat task in children with Unilateral Spastic Cerebral Palsy (USCP) after either constraint-induced movement therapy (CIMT) or hand-arm bimanual intensive therapy (HABIT).
METHODS


Twenty children with USCP (average age 7.7; MACS levels I-II) were randomized into either a CIMT or HABIT group. Both groups received intensive training 6 h a day for 15 days. Children performed a reach-grasp-eat task before and after training with their more-affected hand using 3D kinematic analysis.
RESULTS


Both groups illustrated shorter movement time during reaching, grasping, and eating phases after training ( p  < 0.05). Additionally, both intensive training approaches improved joint control with decreased trunk involvement, greater elbow, and wrist excursions during the reaching phase, and greater elbow excursion during the eating phase ( p  < 0.05). However, only the CIMT group decreased hand curvature during reaching, lowered hand position at grasp, and decreased head rotation during the eating phase ( p  < 0.05).
CONCLUSIONS


The current findings showed that both CIMT and HABIT improved UE joint control, but there were greater effects of CIMT on the more-affected UE motor planning and head control for children with USCP.",2020,"Both groups illustrated shorter movement time during reaching, grasping, and eating phases after training ( p  < 0.05).","['children with Unilateral Spastic Cerebral Palsy (USCP) after either', 'Children with Unilateral Cerebral Palsy', 'children with USCP', 'Twenty children with USCP (average age 7.7; MACS levels I-II']","['Intensive Unimanual Training Leads to Better Reaching and Head Control than Bimanual Training', 'intensive training', 'constraint-induced movement therapy (CIMT) or hand-arm bimanual intensive therapy (HABIT', 'CIMT or HABIT', 'CIMT']","['joint control with decreased trunk involvement, greater elbow, and wrist excursions', 'CIMT and HABIT improved UE joint control', 'elbow excursion', 'shorter movement time during reaching, grasping, and eating phases', 'hand curvature during reaching, lowered hand position at grasp, and decreased head rotation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy (disorder)'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517860', 'cui_str': '7.7 (qualifier value)'}, {'cui': 'C0009545', 'cui_str': 'C5b-9'}, {'cui': 'C0441925', 'cui_str': 'Level I (tumor staging)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy (regime/therapy)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]","[{'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0220843', 'cui_str': 'Grip'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",20.0,0.0133344,"Both groups illustrated shorter movement time during reaching, grasping, and eating phases after training ( p  < 0.05).","[{'ForeName': 'Ya-Ching', 'Initials': 'YC', 'LastName': 'Hung', 'Affiliation': 'Department of Family, Nutrition, and Exercise Sciences, Queens College, City University of New York, Flushing, NY, USA.'}, {'ForeName': 'Aryeh', 'Initials': 'A', 'LastName': 'Spingarn', 'Affiliation': 'Department of Family, Nutrition, and Exercise Sciences, Queens College, City University of New York, Flushing, NY, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Friel', 'Affiliation': 'Neuroscience, Burke Medical Research Institute, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Gordon', 'Affiliation': 'Department of Biobehavioral Sciences, Teachers College, Columbia University, New York, NY, USA.'}]",Physical & occupational therapy in pediatrics,['10.1080/01942638.2020.1712513']
2840,30803899,"Clinical performance of zirconia-ceramic cantilever fixed partial dentures-Longitudinal nine-year results from a prospective, randomized, controlled pilot study.","PURPOSE


The aim of this study was to prospectively compare the clinical performance of veneered zirconia cantilever fixed partial dentures (Z-CFPDs) and metal-ceramic CFPDs (MC-CFPDs) over 9 years of follow-up in terms of survival.
METHODS


Twenty-one participants were assigned by simple randomization to receive either 1 Z-CFPD (n=11) or 1 MC-CFPD (n=10). CFPDs were retained by 2 full crowns and replaced a missing premolar or a central or lateral incisor. Modified USPHS (United States Public Health Service) criteria were used to classify material chipping, retention, marginal integrity, secondary caries, and color of the restorations. The satisfaction of the study participants with the esthetics of their restorations was surveyed; pocket probing depths (PPD), plaque index (PI), and gingival index (GI) were also measured. Study groups were compared by use of U tests (continuous variables), or by use of Fisher exact probability tests (categorical variables) with α=0.05.
RESULTS


Sixteen participants (n=8 with a Z-CFPD and n=8 with an MC-CFPD) attended the 9-year follow-up examination (response rate: 76.2%). Over the 9-year study period, survival of 50% for Z-CFPDs and 75% for MC-CFPDs was recorded (p=0.608). No framework fractures occurred, and no statistically significant differences were observed between the groups regarding changes in PPD, PI, GI, or participant satisfaction (p>0.05). USPHS criteria revealed statistically significantly poorer marginal quality for Z-CFPDs than for MC-CFPDs (p=0.009).
CONCLUSION


Within the limitations of this study, Z and MC-CFPDs demonstrated no statistically significant difference in terms of survival.",2019,"No framework fractures occurred, and no statistically significant differences were observed between the groups regarding changes in PPD, PI, GI, or participant satisfaction (p>0.05).","['Sixteen participants (n=8 with a Z-CFPD and n=8 with an MC-CFPD) attended the 9-year follow-up examination (response rate: 76.2', 'zirconia-ceramic cantilever fixed partial dentures-Longitudinal nine-year', 'Twenty-one participants']","['1 Z-CFPD (n=11) or 1 MC-CFPD', 'Modified USPHS', 'veneered zirconia cantilever fixed partial dentures (Z-CFPDs) and metal-ceramic CFPDs (MC-CFPDs']","['PPD, PI, GI, or participant satisfaction (p>0.05', 'marginal quality', 'survival', 'pocket probing depths (PPD), plaque index (PI), and gingival index (GI']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0007742', 'cui_str': 'Ceramics'}, {'cui': 'C0011461', 'cui_str': 'Fixed Bridge'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0041734', 'cui_str': 'Public Health Service (U.S.)'}, {'cui': 'C0559953', 'cui_str': 'Veneer (physical object)'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0011461', 'cui_str': 'Fixed Bridge'}, {'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C0007742', 'cui_str': 'Ceramics'}]","[{'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017569', 'cui_str': 'Gingival Index'}]",21.0,0.096365,"No framework fractures occurred, and no statistically significant differences were observed between the groups regarding changes in PPD, PI, GI, or participant satisfaction (p>0.05).","[{'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Bömicke', 'Affiliation': 'Department of Prosthetic Dentistry, University Hospital Heidelberg, University of Heidelberg, Heidelberg, Germany. Electronic address: wolfgang.boemicke@med.uni-heidelberg.de.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rammelsberg', 'Affiliation': 'Department of Prosthetic Dentistry, University Hospital Heidelberg, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Zenthöfer', 'Affiliation': 'Department of Prosthetic Dentistry, University Hospital Heidelberg, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Ohlmann', 'Affiliation': 'Department of Prosthetic Dentistry, University Hospital Heidelberg, University of Heidelberg, Heidelberg, Germany.'}]",Journal of prosthodontic research,['10.1016/j.jpor.2019.01.007']
2841,30661011,Physiotherapist-delivered stress inoculation training integrated with exercise versus physiotherapy exercise alone for acute whiplash-associated disorder (StressModex): a randomised controlled trial of a combined psychological/physical intervention.,"OBJECTIVE


There are few effective treatments for acute whiplash-associated disorders (WAD). Early symptoms of postinjury stress predict poor recovery. This randomised controlled trial (StressModex) investigated whether physiotherapist-led stress inoculation training integrated with exercise is more effective than exercise alone for people with acute WAD.
METHODS


108 participants (<4 weeks) at risk of poor recovery (moderate pain-related disability and hyperarousal symptoms) were randomly assigned by concealed allocation to either physiotherapist-led stress inoculation training and guideline-based exercise (n=53) or guideline-based exercise alone (n=55). Both interventions comprised 10 sessions over 6 weeks. Participants were assessed at 6 weeks and at 6 and 12 months postrandomisation. Analysis was by intention to treat using linear mixed models.
RESULTS


The combined stress inoculation training and exercise intervention was more effective than exercise alone for the primary outcome of pain-related disability at all follow-up points. At 6 weeks, the treatment effect on the 0-100 Neck Disability Index was (mean difference) -10 (95% CI -15.5 to -4.48), at 6 months was -7.8 (95% CI -13.8 to -1.8) and at 12 months was -10.1 (95% CI -16.3 to -4.0). A significant benefit of the stress inoculation and exercise intervention over exercise alone was also found for some secondary outcomes.
CONCLUSION


A physiotherapist-led intervention of stress inoculation training and exercise resulted in clinically relevant improvements in disability compared with exercise alone-the most commonly recommended treatment for acute WAD. This contributes to the case for physiotherapists to deliver an early psychological intervention to patients with acute WAD who are otherwise at high risk of a poor outcome.
TRIAL REGISTRATION NUMBER


ACTRN12614001036606.",2019,The combined stress inoculation training and exercise intervention was more effective than exercise alone for the primary outcome of pain-related disability at all follow-up points.,"['108 participants (<4 weeks) at risk of poor recovery (moderate pain-related disability and hyperarousal symptoms', 'patients with acute WAD who are otherwise at high risk of a poor outcome', 'acute whiplash-associated disorder (StressModex', 'people with acute WAD']","['Physiotherapist-delivered stress inoculation training integrated with exercise versus physiotherapy exercise alone', 'physiotherapist-led stress inoculation training and guideline-based exercise (n=53) or guideline-based exercise alone', 'combined psychological/physical intervention', 'physiotherapist-led stress inoculation training integrated with exercise', 'combined stress inoculation training and exercise intervention']","['pain-related disability', '0-100 Neck Disability Index']","[{'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain (finding)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",108.0,0.148315,The combined stress inoculation training and exercise intervention was more effective than exercise alone for the primary outcome of pain-related disability at all follow-up points.,"[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Sterling', 'Affiliation': 'Recover Injury Research Centre and NHMRC CRE in Road Traffic Injury Recovery, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Smeets', 'Affiliation': 'Department of Rehabilitation Medicine, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Gerben', 'Initials': 'G', 'LastName': 'Keijzers', 'Affiliation': 'Department of Emergency Medicine, Gold Coast University Hospital, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Jacelle', 'Initials': 'J', 'LastName': 'Warren', 'Affiliation': 'Recover Injury Research Centre and NHMRC CRE in Road Traffic Injury Recovery, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Kenardy', 'Affiliation': 'School of Psychology, The University of Queensland, Brisbane, Queensland, Australia.'}]",British journal of sports medicine,['10.1136/bjsports-2018-100139']
2842,31854271,Effects of a Digital Self-care Intervention in Adults with COPD: A Pilot Study.,"Self-care improves quality of life, and reduces exacerbations and mortality risk in people with chronic obstructive pulmonary disease (COPD). The purpose of this report is to describe the development and testing of the feasibility and acceptability of a digital, educational self-care intervention designed to improve self-care ability, adherence, knowledge, somatic symptoms, anxiety, and depressive symptoms.This pilot study was a quasi-experimental, repeated measures design. Self-care behaviors were identified, and educational modules were developed and built into a web-based platform. Twenty participants were enrolled to determine feasibility, acceptability, and preliminary efficacy.The intervention was deemed acceptable and feasible as evidenced by > 95% completion rates and high degree of participation. Overall, the intervention was well received and is feasible for future home-based interventions in those with COPD. Results included significant improvements in adherence and knowledge, and significant associations between self-care ability, adherence, and depressive symptoms.",2020,"Results included significant improvements in adherence and knowledge, and significant associations between self-care ability, adherence, and depressive symptoms.","['Twenty participants', 'people with chronic obstructive pulmonary disease (COPD', 'Adults with COPD']","['digital, educational self-care intervention', 'Digital Self-care Intervention']","['self-care ability, adherence, knowledge, somatic symptoms, anxiety, and depressive symptoms', 'adherence and knowledge, and significant associations between self-care ability, adherence, and depressive symptoms', 'quality of life']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}]","[{'cui': 'C0562734', 'cui_str': 'Ability to perform self-care activities'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C3839861', 'cui_str': 'Medically Unexplained Symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0034380'}]",20.0,0.0382194,"Results included significant improvements in adherence and knowledge, and significant associations between self-care ability, adherence, and depressive symptoms.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bugajski', 'Affiliation': 'College of Nursing, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Susan K', 'Initials': 'SK', 'LastName': 'Frazier', 'Affiliation': 'College of Nursing, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Lakeshia', 'Initials': 'L', 'LastName': 'Cousin', 'Affiliation': 'College of Nursing, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Rechenberg', 'Affiliation': 'College of Nursing, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Jaelyn', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'College of Nursing, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Lengerich', 'Affiliation': 'College of Nursing, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Moser', 'Affiliation': 'College of Nursing, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Terry A', 'Initials': 'TA', 'LastName': 'Lennie', 'Affiliation': 'College of Nursing, University of Kentucky, Lexington, KY, USA.'}]",Western journal of nursing research,['10.1177/0193945919892282']
2843,31503134,Short-term changes in dietary sodium intake influence sweat sodium concentration and muscle sodium content in healthy individuals.,"OBJECTIVE


There is increasing evidence that sodium can be stored in the skin and muscles without being osmotically active, yet whether acute changes in dietary sodium intake alter sweat and muscle sodium content has not been investigated previously.
METHODS


In a cross-over design, we assessed muscle sodium content by Na-MRI in 38 healthy normotensive volunteers (aged 33.5 ± 11.1 years, 76.3% women) after 5 days of high-sodium diet (6 g of salt added to their normal diet) and 5 days of a low-sodium diet. In a subgroup of 18 participants (72.2% women) we conducted quantitative pilocarpine iontophoretic sweat collections and measured the sodium concentration in sweat. Plasma aldosterone and plasma renin activity levels were measured in all participants.
RESULTS


Under high-sodium diet conditions urinary sodium excretion, muscle sodium content and sweat sodium concentration all increased significantly. Muscle sodium content (rm = 0.47, P = 0.03) and sodium sweat concentration (rm = 0.72, P < 0.001) correlated positively with salt intake as estimated by 24-h urine sodium excretion. Age, sex or the phase of the menstrual cycle did not influence muscle or sweat sodium concentrations or their changes. In contrast, plasma aldosterone levels were negatively associated with both muscle sodium (rs = -0.42, P = 0.0001) and sweat sodium content (rs = -0.52, P = 0.002). Plasma renin activity correlated negatively with sweat sodium (rs = -0.43, P = 0.012) and muscle sodium levels (rs = -0.42, P < 0.001).
CONCLUSION


Muscle and sweat sodium concentrations are significantly higher on a high-salt intake in healthy male and female individuals, suggesting that muscle and sweat play a role in regulating sodium balance in humans.",2020,"Muscle sodium content (rm = 0.47, P = 0.03) and sodium sweat concentration (rm = 0.72, P < 0.001) correlated positively with salt intake as estimated by 24-h urine sodium excretion.","['healthy male and female individuals', 'healthy individuals', '38 healthy normotensive volunteers (aged 33.5\u200a±\u200a11.1 years, 76.3% women) after 5 days of']",['high-sodium diet (6\u200ag of salt added to their normal diet) and 5 days of a low-sodium diet'],"['sodium sweat concentration', 'muscle sodium levels', 'sodium excretion, muscle sodium content and sweat sodium concentration', 'Plasma aldosterone and plasma renin activity levels', 'plasma aldosterone levels', 'sweat sodium content', 'Muscle sodium content', 'Plasma renin activity']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0452340', 'cui_str': 'High sodium diet'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0184625', 'cui_str': 'Regular diet'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0012169', 'cui_str': 'Diet, Low-Salt'}]","[{'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0038990', 'cui_str': 'Sweating'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0428291', 'cui_str': 'Finding of sodium level (finding)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0857639', 'cui_str': 'Plasma aldosterone'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1272143', 'cui_str': 'Plasma aldosterone level'}]",38.0,0.0178432,"Muscle sodium content (rm = 0.47, P = 0.03) and sodium sweat concentration (rm = 0.72, P < 0.001) correlated positively with salt intake as estimated by 24-h urine sodium excretion.","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Braconnier', 'Affiliation': 'Service of Nephrology and Hypertension.'}, {'ForeName': 'Bastien', 'Initials': 'B', 'LastName': 'Milani', 'Affiliation': 'Service of Radiology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Loncle', 'Affiliation': 'Service of Nephrology and Hypertension.'}, {'ForeName': 'Joao M', 'Initials': 'JM', 'LastName': 'Lourenco', 'Affiliation': 'Service of Nephrology and Hypertension.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Brito', 'Affiliation': 'Service of Nephrology and Hypertension.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Delacoste', 'Affiliation': 'Service of Radiology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Maillard', 'Affiliation': 'Service of Nephrology and Hypertension.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Stuber', 'Affiliation': 'Service of Radiology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Burnier', 'Affiliation': 'Service of Nephrology and Hypertension.'}, {'ForeName': 'Menno', 'Initials': 'M', 'LastName': 'Pruijm', 'Affiliation': 'Service of Nephrology and Hypertension.'}]",Journal of hypertension,['10.1097/HJH.0000000000002234']
2844,30648131,Randomized Controlled Pilot Study of Antiretrovirals and a Behavioral Intervention for Persons With Acute HIV Infection: Opportunity for Interrupting Transmission.,"Background


Persons with acute HIV infection (AHI) have heightened transmission risk. We evaluated potential transmission reduction using behavioral and biomedical interventions in a randomized controlled pilot study in Malawi.
Methods


Persons were randomized 1:2:2 to standard counseling (SC), 5-session behavioral intervention (BI), or behavioral intervention plus 12 weeks of antiretrovirals (ARVs; BIA). All were followed for 26-52 weeks and, regardless of arm, referred for treatment according to Malawi-ARV guidelines. Participants were asked to refer partners for testing.
Results


Among 46 persons (9 SC, 18 BI, 19 BIA), the average age was 28; 61% were male. The median viral load (VL) was 5.9 log copies/mL at enrollment. 67% (10/15) of BIA participants were suppressed (<1000 copies/mL) at week 12 vs 25% BI and 50% SC ( P  = .07). Although the mean number of reported condomless sexual acts in the past week decreased from baseline across all arms (1.5 vs 0.3 acts), 36% experienced incident sexually transmitted infection by 52 weeks (12% SC, 28% BI, 18% BIA). Forty-one percent (19/46) of participants referred partners (44% SC, 44% BI, 37% BIA); 15 of the partners were HIV-infected.
Conclusions


Diagnosis of AHI facilitates behavioral and biomedical risk reduction strategies during a high-transmission period that begins years before people are typically identified and started on ARVs. Sexually transmitted infection incidence in this cohort suggests ongoing risk behaviors, reinforcing the importance of early intervention with ARVs to reduce transmission. Early diagnosis coupled with standard AHI counseling and early ARV referral quickly suppresses viremia, may effectively change behavior, and could have tremendous public health benefit in reducing onward transmission.",2019,67% (10/15) of BIA participants were suppressed (<1000 copies/mL) at week 12 vs 25% BI and 50% SC ( P  = .07).,"['\n\n\nPersons with acute HIV infection (AHI', 'Persons With Acute HIV Infection', 'Forty-one percent (19/46) of participants', '46 persons (9 SC, 18 BI, 19 BIA), the average age was 28; 61% were male']","['Behavioral Intervention', 'Antiretrovirals', 'standard counseling (SC), 5-session behavioral intervention (BI), or behavioral intervention plus 12 weeks of antiretrovirals (ARVs; BIA']","['median viral load (VL', 'incident sexually transmitted infection']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0343752', 'cui_str': 'Acute human immunodeficiency virus seroconversion illness'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0036916', 'cui_str': 'STDs'}]",,0.0853712,67% (10/15) of BIA participants were suppressed (<1000 copies/mL) at week 12 vs 25% BI and 50% SC ( P  = .07).,"[{'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Miller', 'Affiliation': 'Division of Epidemiology, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Rutstein', 'Affiliation': 'Division of Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Phiri', 'Affiliation': 'Lighthouse Trust, Lilongwe, Malawi.'}, {'ForeName': 'Gift', 'Initials': 'G', 'LastName': 'Kamanga', 'Affiliation': 'UNC Project, Lilongwe, Malawi.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Nsona', 'Affiliation': 'Lighthouse Trust, Lilongwe, Malawi.'}, {'ForeName': 'Dana K', 'Initials': 'DK', 'LastName': 'Pasquale', 'Affiliation': 'Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Rucinski', 'Affiliation': 'Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Jane S', 'Initials': 'JS', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Carol E', 'Initials': 'CE', 'LastName': 'Golin', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Powers', 'Affiliation': 'Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Dennis', 'Affiliation': 'Division of Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'Division of Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Eron', 'Affiliation': 'Division of Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Wairimu', 'Initials': 'W', 'LastName': 'Chege', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Irving F', 'Initials': 'IF', 'LastName': 'Hoffman', 'Affiliation': 'Division of Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Audrey E', 'Initials': 'AE', 'LastName': 'Pettifor', 'Affiliation': 'Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}]",Open forum infectious diseases,['10.1093/ofid/ofy341']
2845,31200321,Prognostic and predictive value of AJCC-8 staging in the phase III EORTC1325/KEYNOTE-054 trial of pembrolizumab vs placebo in resected high-risk stage III melanoma.,"BACKGROUND


The American Joint Committee on Cancer-8 (AJCC) classification of melanoma was implemented in January 2018. It was based on data gathered when checkpoint inhibitors were not used as adjuvant therapy in stage III melanoma. The European Organization for Research and Treatment of Cancer (EORTC) 1325/KEYNOTE-054 double-blind phase III trial evaluated pembrolizumab vs placebo in AJCC-7 stage IIIA (excluding lymph node metastasis ≤1 mm), IIIB or IIIC (without in-transit metastasis) patients after complete lymphadenectomy.
PATIENTS, METHODS AND RESULTS


Patients (n = 1019) were randomised 1:1 to pembrolizumab 200 mg or placebo every 3 weeks (total of 18 doses, ∼1 year). At 1.25-year median follow-up, pembrolizumab prolonged relapse-free survival (RFS) in the total population (1-year RFS rate: 75.4% vs 61.0%; hazard ratio [HR] 0.57; logrank P < 0.0001) and consistently in the AJCC-7 subgroups. Prognostic and predictive values of AJCC-8 for RFS were evaluated in this study. Patient distribution according to the AJCC-8 stage subgroups was 8% (IIIA), 34.7% (IIIB), 49.7% (IIIC), 3.7% (IIID) and 3.8% (unknown). AJCC-8 classification was strongly associated with RFS (HRs for stage IIIB, IIIC and IIID vs IIIA were 4.0, 5.7 and 12.2, respectively) but showed no predictive importance for the treatment comparison regarding RFS (test for interaction: P = 0.68). The 1-year RFS rate for pembrolizumab vs placebo and the HRs (99% confidence interval) within each AJCC-8 subgroup were as follows: stage IIIA (92.7% vs 92.5%; 0.76 [0.11-5.43]), IIIB (79.0% vs 65.5%; 0.59 [0.35-0.99]), IIIC (73.6% vs 53.9%; 0.48 [0.33-0.70]) and IIID (50.0% vs 33.3%; 0.69 [0.24-2.00]).
CONCLUSIONS


AJCC-8 staging had a strong prognostic importance for RFS but no predictive importance: the RFS benefit of pembrolizumab was observed across AJCC-8 subgroups in resected high-risk stage III melanoma patients.",2019,"AJCC-8 classification was strongly associated with RFS (HRs for stage IIIB, IIIC and IIID vs IIIA were 4.0, 5.7 and 12.2, respectively) but showed no predictive importance for the treatment comparison regarding RFS (test for interaction: P = 0.68).","['Cancer (EORTC', 'Patients (n\xa0', 'AJCC-7 stage', '1019', 'resected high-risk stage III melanoma']","['pembrolizumab vs placebo', 'pembrolizumab 200\xa0mg or placebo']","['pembrolizumab prolonged relapse-free survival (RFS', 'RFS (HRs for stage IIIB, IIIC\xa0and IIID vs IIIA', '1-year RFS rate']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0450318', 'cui_str': '1019'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",1019.0,0.585471,"AJCC-8 classification was strongly associated with RFS (HRs for stage IIIB, IIIC and IIID vs IIIA were 4.0, 5.7 and 12.2, respectively) but showed no predictive importance for the treatment comparison regarding RFS (test for interaction: P = 0.68).","[{'ForeName': 'Alexander M M', 'Initials': 'AMM', 'LastName': 'Eggermont', 'Affiliation': 'Gustave Roussy Cancer Campus Grand Paris, Villejuif, France. Electronic address: alexander.eggermont@gustaveroussy.fr.'}, {'ForeName': 'Christian U', 'Initials': 'CU', 'LastName': 'Blank', 'Affiliation': 'Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mandala', 'Affiliation': 'Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, and Mater and Royal North Shore Hospitals, Sydney, NSW, Australia.'}, {'ForeName': 'Victoria G', 'Initials': 'VG', 'LastName': 'Atkinson', 'Affiliation': 'Princess Alexandra Hospital, Brisbane, QLD, Australia.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Dalle', 'Affiliation': 'Hospices Civils de Lyon Cancer Institute, Lyon, France.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haydon', 'Affiliation': 'Alfred Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Lichinitser', 'Affiliation': 'Russian Oncology Scientific Centre, Moscow, Russia.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Khattak', 'Affiliation': 'Fiona Stanley Hospital/University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Matteo S', 'Initials': 'MS', 'LastName': 'Carlino', 'Affiliation': 'Westmead and Blacktown Hospitals, Melanoma Institute Australia and the University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Shahneen', 'Initials': 'S', 'LastName': 'Sandhu', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Puig', 'Affiliation': 'Hospital Clinic Universitari de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Istituto Nazionale Tumori IRCCS ""Fondazione G. Pascale"", Naples, Italy.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Maria Sklodowska-Curie Institute - Oncology Center, Warsaw, Poland.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Universitaetsklinikum - University Essen, Essen, Germany.'}, {'ForeName': 'Rutger', 'Initials': 'R', 'LastName': 'Koornstra', 'Affiliation': 'Radboud University Medical Center Nijmegen, Nijmegen, the Netherlands.'}, {'ForeName': 'Leonel', 'Initials': 'L', 'LastName': 'Hernandez-Aya', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Di Giacomo', 'Affiliation': 'Center for Immuno-Oncology, University Hospital of Siena, Siena, Italy.'}, {'ForeName': 'Alfonsus Jm', 'Initials': 'AJ', 'LastName': 'van den Eertwegh', 'Affiliation': 'Amsterdam University Medical Center, Location VUMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Aix Marseille University, Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Skin Cancer Center, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Rahima', 'Initials': 'R', 'LastName': 'Jamal', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal (CHUM), Centre de recherche du CHUM, Montreal, QC, Canada.""}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Lorigan', 'Affiliation': 'Christie NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lupinacci', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, United States.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Krepler', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, United States.'}, {'ForeName': 'Nageatte', 'Initials': 'N', 'LastName': 'Ibrahim', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, United States.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kicinski', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Marreaud', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'van Akkooi', 'Affiliation': 'Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Gustave Roussy Cancer Campus Grand Paris, Villejuif, France.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.05.020']
2846,31797310,Renin-Angiotensin-Aldosterone System Optimization for Acute Decompensated Heart Failure Patients (ROAD-HF): Rationale and Design.,"INTRODUCTION


The long-term benefits of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) on outcomes in patients with chronic congestive heart failure are well-known, making them one of the most widely prescribed medications. However, the administration of ACEIs/ARBs in acute decompensated heart failure (ADHF) can increase the risk of morbidity and mortality secondary to worsening renal function (WRF). A decrease in estimated glomerular filtration rate (eGFR) during the treatment of ADHF has been associated with an increase in mortality proportional to the degree of WRF.
AIM


The aim of our study is to determine whether withholding ACEIs/ARBs during the initial 72 h of admission in patients with ADHF will prevent WRF and allow more effective diuresis.
METHODS


Four hundred and thirty patients will be randomized to the intervention (withholding ACEIs/ARBs) or control (continue/start ACEIs/ARBs) arms for 72 h. Primary outcomes include rates of acute kidney injury (AKI), patient global assessment, and change in kinetic eGFR over 72 h, while secondary outcomes include change in weight, fluid balance, change in signs and symptoms of congestion, change in renal function, change in urinary biomarkers (tissue inhibitor of metalloproteinases 2 [TIMP-2] × insulin-like growth factor-binding protein 7 [IGFBP7]), patients experiencing treatment failure, hospital length of stay (LOS), cost analysis, mortality within 30 days, and hospital readmissions over 30 days and 1 year.
CONCLUSION


This prospective clinical trial will prove if withholding ACEIs/ARBs will prevent AKI in ADHF. It will help us understand the complex interactions between the heart and kidney, and delineate the best treatment strategy for ADHF. Holding ACEIs/ARBs might help preserve renal function, and decrease hospital LOS, readmission rates, and cost of care in ADHF.
REGISTRATION


ClinicalTrials.gov identifier: NCT03695120.",2020,"Holding ACEIs/ARBs might help preserve renal function, and decrease hospital LOS, readmission rates, and cost of care in ADHF.
","['patients with ADHF', 'Acute Decompensated Heart Failure Patients (ROAD-HF', 'patients experiencing treatment failure, hospital length of stay (LOS), cost analysis, mortality within 30 days, and hospital readmissions over 30\xa0days and 1\xa0year', 'patients with chronic congestive heart failure', 'Four hundred and thirty patients']","['intervention (withholding ACEIs/ARBs) or control (continue/start ACEIs/ARBs', 'ACEIs/ARBs', 'Renin-Angiotensin-Aldosterone System Optimization', 'withholding ACEIs/ARBs', 'angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs']","['estimated glomerular filtration rate (eGFR', 'rates of acute kidney injury (AKI), patient global assessment, and change in kinetic eGFR over 72\xa0h, while secondary outcomes include change in weight, fluid balance, change in signs and symptoms of congestion, change in renal function, change in urinary biomarkers (tissue inhibitor of metalloproteinases 2 [TIMP-2', 'hospital LOS, readmission rates, and cost of care in ADHF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1609524', 'cui_str': 'Acute decompensated heart failure'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0442650', 'cui_str': 'Road (environment)'}, {'cui': 'C0162643'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0010171', 'cui_str': 'Cost Analysis'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0264722', 'cui_str': 'Chronic congestive heart failure (disorder)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1264693', 'cui_str': 'Arbitrary'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor (substance)'}]","[{'cui': 'C3811844'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0016284', 'cui_str': 'Fluid Balance'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0700148', 'cui_str': 'Congestion (morphologic abnormality)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0145946', 'cui_str': 'Tissue Inhibitor of Metalloproteinase-2'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1609524', 'cui_str': 'Acute decompensated heart failure'}]",430.0,0.0640647,"Holding ACEIs/ARBs might help preserve renal function, and decrease hospital LOS, readmission rates, and cost of care in ADHF.
","[{'ForeName': 'Bhagwan', 'Initials': 'B', 'LastName': 'Dass', 'Affiliation': 'Division of Hospital Medicine, University of Florida, PO Box 100238, Gainesville, FL, 32610, USA. Bhagwan.Dass@medicine.ufl.edu.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Dimza', 'Affiliation': 'Department of Internal Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Girish', 'Initials': 'G', 'LastName': 'Singhania', 'Affiliation': 'Department of Hospital Medicine, CHI St. Vincent Infirmary, Little Rock, AR, USA.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Schwartz', 'Affiliation': 'Department of Internal Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Jerin', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Department of Internal Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Avni', 'Initials': 'A', 'LastName': 'Bhatt', 'Affiliation': 'Department of Pediatrics, Division of Hospital Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Nila', 'Initials': 'N', 'LastName': 'Radhakrishnan', 'Affiliation': 'Division of Hospital Medicine, University of Florida, PO Box 100238, Gainesville, FL, 32610, USA.'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Bansari', 'Affiliation': 'Division of Hospital Medicine, University of Florida, PO Box 100238, Gainesville, FL, 32610, USA.'}, {'ForeName': 'Shahab', 'Initials': 'S', 'LastName': 'Bozorgmehri', 'Affiliation': 'Division of Nephrology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Mohandas', 'Affiliation': 'Division of Nephrology, University of Florida, Gainesville, FL, USA.'}]","American journal of cardiovascular drugs : drugs, devices, and other interventions",['10.1007/s40256-019-00389-7']
2847,30704929,Impact of sleep bruxism on training-induced cortical plasticity.,"PURPOSE


To investigate if sleep bruxism (SB) influences training-induced cortical plasticity and performance in terms of accuracy and precision of a tooth-clenching task (TCT).
METHODS


Thirty-eight participants were allocated into SB group (N=19) and control group (N=19) according to presence of SB based on a 2-week screening. The participants were instructed to perform a standardized TCT for 58min at three different force levels (10%, 20% and 40% of maximum voluntary contraction; MVC) in three series (first and third without visual-feedback and second with visual-feedback). Accuracy and precision of the TCT were calculated from actual bite force values. Transcranial magnetic stimulation was applied to elicit motor evoked potentials (MEPs) from the masseter and first dorsal interosseous muscle (FDI) before the TCT (pre-TCT-session) and 5-min after the TCT (post-TCT-session).
RESULTS


Accuracy was significantly dependent on the series and target force level (P<0.001), however, there was a significant decrease only in the control group at 10% MVC from first to third session (P<0.001). No significant differences between groups were observed for the precision of the TCT. Masseter MEPs in the SB group in the pre-TCT-session at 120% and 160% motor threshold were significantly lower than in the control group (P<0.05). Masseter MEPs of the control group in the post-TCT-session were significantly higher than the pre-TCT-session (P<0.05) but not SB. FDI MEPs were only dependent on stimulus intensity (P<0.001).
CONCLUSIONS


SB is associated with significant changes not only in excitability of corticomotor control but also motor learning of jaw movements and force control.",2019,"RESULTS


Accuracy was significantly dependent on the series and target force level (P<0.001), however, there was a significant decrease only in the control group at 10% MVC from first to third session (P<0.001).",['Thirty-eight participants were allocated into SB group (N=19) and control group (N=19) according to presence of SB based on a 2-week screening'],['Transcranial magnetic stimulation'],"['accuracy and precision of a tooth-clenching task (TCT', 'precision of the TCT', 'Masseter MEPs', 'Accuracy and precision of the TCT']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}]","[{'cui': 'C0424444', 'cui_str': 'Clenching teeth (finding)'}, {'cui': 'C0677634', 'cui_str': 'Reptilase Time'}]",38.0,0.0289361,"RESULTS


Accuracy was significantly dependent on the series and target force level (P<0.001), however, there was a significant decrease only in the control group at 10% MVC from first to third session (P<0.001).","[{'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Ikuta', 'Affiliation': 'Division of Oral Function and Rehabilitation, Department of Oral Health Science, Nihon University School of Dentistry at Matsudo, Matsudo, Japan; Section of Orofacial Pain and Jaw Function, Aarhus University, Department of Dentistry, Aarhus, Denmark.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Iida', 'Affiliation': 'Division of Oral Function and Rehabilitation, Department of Oral Health Science, Nihon University School of Dentistry at Matsudo, Matsudo, Japan. Electronic address: iida.takashi96@nihon-u.ac.jp.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Kothari', 'Affiliation': 'Hammel Neurorehabilitation Centre and University Research Clinic, Hammel, Denmark; Department of Clinic Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Shimada', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Aarhus University, Department of Dentistry, Aarhus, Denmark; Osaka Dental University Hospital, Osaka, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Komiyama', 'Affiliation': 'Division of Oral Function and Rehabilitation, Department of Oral Health Science, Nihon University School of Dentistry at Matsudo, Matsudo, Japan.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Svensson', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Aarhus University, Department of Dentistry, Aarhus, Denmark; Scandinavian Center for Orofacial Neurosciences (SCON), Aarhus, Denmark; Department of Dental Medicine, Karolinska Institutet, Huddinge, Sweden.'}]",Journal of prosthodontic research,['10.1016/j.jpor.2018.12.008']
2848,31808180,E-Learning Training to Improve Pediatric Parenteral Nutrition Practice: A Pilot Study in Two University Hospitals.,"BACKGROUND


Education and training may improve the prescription of pediatric parenteral nutrition. The aim was to evaluate the impact of an e-learning method on parenteral nutrition prescription skills among pediatric residents in 2 pediatric hospitals.
METHODS


A randomized double-blind control study was conducted over a 9-month period among pediatric residents in HOSP1, Geneva, Switzerland, where physicians prescribe parenteral nutrition directly, and in HOSP2, Montreal, Canada, where physicians prescribe only occasionally because clinical pharmacists are devoted to this activity. The intervention consisted of an e-learning session about key issues of parenteral nutrition. Physician parenteral nutrition knowledge was evaluated with a standardized questionnaire based on clinical cases before and after the e-learning in the intervention groups; in the control groups, only the 2 tests were conducted. In HOSP1, participants also underwent iterative tests every 2 months to measure the retention of knowledge.
RESULTS


Sixty-five physicians participated. Initial knowledge scores were higher in HOSP1 (pretest scores 180 ± 29 vs 133 ± 24, p < 0.001). Overall, there was no significant difference in the impact of the e-learning intervention between the control and e-learning groups (p > 0.05). A significant knowledge improvement was observed in HOSP2 in the e-learning group (p = 0.033). Iterative tests in HOSP1 showed persistence of knowledge without significant differences between the groups. E-learning satisfaction among the participants was outstanding (100%).
CONCLUSION


E-learning seems to be an effective method for teaching parenteral nutrition among pediatric residents and fellows at the beginning of the training. High satisfaction with this teaching method was observed in this study.",2020,"Overall, there was no significant difference in the impact of the e-learning intervention between the control and e-learning groups (p > 0.05).","['Sixty-five physicians participated', 'Pediatric Parenteral Nutrition Practice', 'pediatric residents in 2 pediatric hospitals', 'pediatric residents in HOSP1, Geneva, Switzerland, where physicians prescribe parenteral nutrition directly, and in HOSP2, Montreal, Canada, where physicians prescribe only occasionally because clinical pharmacists', 'Two University Hospitals']","['e-learning method', 'parenteral nutrition prescription skills', 'E-Learning Training']","['impact of the e-learning intervention', 'E-learning satisfaction', 'retention of knowledge', 'HOSP2', 'Initial knowledge scores']","[{'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C1449564', 'cui_str': 'Clinical Pharmacists'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0231644,"Overall, there was no significant difference in the impact of the e-learning intervention between the control and e-learning groups (p > 0.05).","[{'ForeName': 'Laetitia-Marie', 'Initials': 'LM', 'LastName': 'Petit', 'Affiliation': 'Geneva University Hospitals, Department of Pediatrics, Pediatric Gastroenterology, Hepatology, and Nutrition Unit, Geneva, Switzerland.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Le Pape', 'Affiliation': 'Geneva University Hospitals, Pharmacy Division, Geneva, Switzerland.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Delestras', 'Affiliation': 'Geneva University Hospitals, Pharmacy Division, Geneva, Switzerland.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Nguyen', 'Affiliation': 'Centre Hospitalier Universitaire Sainte-Justine, Department of Pharmacy and University of Montreal, Montreal, Québec, Canada.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Marchand', 'Affiliation': 'Centre Hospitalier Universitaire Sainte-Justine, Department of Pediatric Gastroenterology, Hepatology and Nutrition, University of Montreal, Montreal, Québec, Canada.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Belli', 'Affiliation': 'Geneva University Hospitals, Department of Pediatrics, Pediatric Gastroenterology, Hepatology, and Nutrition Unit, Geneva, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Bonnabry', 'Affiliation': 'Geneva University Hospitals, Pharmacy Division, Geneva, Switzerland.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Bajwa', 'Affiliation': 'Geneva University Hospitals, Department of Pediatrics, Geneva, Switzerland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fonzo-Christe', 'Affiliation': 'Geneva University Hospitals, Pharmacy Division, Geneva, Switzerland.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1730']
2849,31906801,Effects of Balance Training on Balance Performance in Youth: Are There Age Differences?,"Purpose : In youth, cross-sectional studies reported age differences in balance performance that were in favor of adolescents. Thus, trainability of balance performance might be different in children compared to adolescents. The purpose of this study was therefore to compare the effects of balance training (BT) on balance performance between children and adolescents. Method : Thirty children (7.5 ± 0.5 years) and 42 adolescents (14.7 ± 0.5 years) participated in this study and were assigned to either a BT-group or a control (CON) group. In both age groups, BT was conducted over five weeks while the CON-groups received their regular physical education lessons. Pre- and posttests included the assessment of mobility, static steady-state, proactive, and reactive balance. Results : Significant Test × Group × Age interactions were found for static steady-state balance (i.e., CoP displacements during single leg stance) and mobility (i.e., 10-m gait velocity). For both measures, post hoc analysis revealed larger improvements (+16-37%, 0.001 ≤  p  ≤ 0.033, 0.65 ≤  d  ≤ 2.24) for children compared to adolescents. For proxies of proactive and reactive balance, we could not detect significant Test × Group × Age interactions. Conclusions : We conclude that trainability of static steady-state balance and mobility seems to be higher in children than in adolescents indicating larger adaptive reserves in children compared to adolescents. However, there were no age differences in adaptations to BT with respect to proactive and reactive balance.",2020,"For both measures, post hoc analysis revealed larger improvements (+16-37%, 0.001 ≤  p  ≤ 0.033, 0.65 ≤  d  ≤ 2.24) for children compared to adolescents.","['Youth', 'Thirty children (7.5\xa0±\xa00.5\xa0years) and 42 adolescents (14.7\xa0±\xa00.5\xa0years', 'children and adolescents']","['Balance Training', 'balance training (BT', 'CON-groups received their regular physical education lessons', 'BT-group or a control (CON']","['assessment of mobility, static steady-state, proactive, and reactive balance', 'balance performance', 'static steady-state balance (i.e., CoP displacements', 'Balance Performance']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0031805', 'cui_str': 'Physical Education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2317515', 'cui_str': 'Assessment of mobility (procedure)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}]",30.0,0.0210385,"For both measures, post hoc analysis revealed larger improvements (+16-37%, 0.001 ≤  p  ≤ 0.033, 0.65 ≤  d  ≤ 2.24) for children compared to adolescents.","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Schedler', 'Affiliation': 'University of Duisburg-Essen.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Brock', 'Affiliation': 'University of Duisburg-Essen.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Fleischhauer', 'Affiliation': 'University of Duisburg-Essen.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Kiss', 'Affiliation': 'FHM Bielefeld - University of Applied Sciences.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Muehlbauer', 'Affiliation': 'University of Duisburg-Essen.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2019.1676371']
2850,31903494,Evaluating the Effects of a Brief Tobacco Intervention in the U.S. Air Force.,"INTRODUCTION


Military personnel have among the highest rates of tobacco use in the US. Unfortunately, there are few interventions aimed at reducing tobacco use among this vulnerable population. The current study addresses this need by evaluating the short-term effectiveness of a Brief Tobacco Intervention (BTI), a 40-minute group-based intervention designed to reduce contemporary patterns of tobacco use among a sample of US military enlistees during an 11-week period of involuntary tobacco abstinence.
METHODS


Participants were 2,999 US Air Force Technical Trainees at Joint Base San Antonio-Lackland Air Force Base in San Antonio, Texas from April 2017 through January 2018. Participants were cluster randomized to three conditions: (1) BTI + Airman's Guide to Remaining Tobacco Free (AG), (2) AG intervention, or (3) standard smoking cessation intervention. The primary analysis was a comparison of the interventions' efficacies in preventing tobacco use during Technical Training, conducted using a generalized estimating equations logistic regression model controlling for covariates. Multiple imputation was used to account for loss to follow-up.
RESULTS


There was not a significant difference by condition in the use of tobacco products at follow-up (p=0.454). The BTI + AG condition did produce short-term changes in perceived harm, intentions to use tobacco, knowledge about tobacco products, and normative beliefs.
CONCLUSIONS


These findings suggest that while the intervention was effective in the short-term, it was not potent enough over a 12-week period to prevent Airmen from initiating tobacco use. Future studies should examine whether adding a booster session or media campaign enhances the effectiveness of the intervention.",2020,There was not a significant difference by condition in the use of tobacco products at follow-up (p=0.454).,"['Participants were 2,999 US Air Force Technical Trainees at Joint Base San Antonio-Lackland Air Force Base in San Antonio, Texas from April 2017 through January 2018']","['Brief Tobacco Intervention (BTI', 'Brief Tobacco Intervention', ""BTI + Airman's Guide to Remaining Tobacco Free (AG), (2) AG intervention, or (3) standard smoking cessation intervention""]",[],"[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039711', 'cui_str': 'Texas'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C4521691', 'cui_str': 'US Military enlisted E2'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]",[],,0.0315383,There was not a significant difference by condition in the use of tobacco products at follow-up (p=0.454).,"[{'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Little', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'Fahey', 'Affiliation': 'University of Memphis, Memphis, TN.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Klesges', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'McMurry', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Gerald W', 'Initials': 'GW', 'LastName': 'Talcott', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, VA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa001']
2851,31366683,Local Anesthesia With General Anesthesia for Pediatric Bone Marrow Procedures.,"BACKGROUND


Pediatric patients with cancer undergo repeated painful procedures, including bone marrow aspirations and biopsies (BMABs). Optimal management of procedure-related pain can reduce discomfort, anxiety, and distress.
METHODS


Children with neuroblastoma were randomly assigned to 1 of 2 arms on a prospective, single-blind, crossover trial conducted at Memorial Sloan Kettering Cancer Center from October 2016 to January 2018 (www.clinicaltrials.gov, identifier NCT02924324). Participants underwent 2 sequential BMABs: one with general anesthesia (GA) alone, the other with GA plus local anesthesia (LA) (GA + LA). The objective was to assess procedure-related pain and its interference with quality of life (QoL) with GA versus GA + LA. Primary outcome was percentage of participants requiring postprocedural opioids. Secondary outcomes were total opioid and nonopioid analgesics, pain scores, time to first analgesic, QoL, and toxicity. Management of postprocedural pain was standardized.
RESULTS


Of 56 participants randomly assigned (3-16.5 years old), 46 completed both procedures. There was no significant difference in percentage of participants requiring opioids with GA versus GA + LA (24% vs 20%,  P  = .5). Pain scores in the recovery room were significantly lower for GA + LA versus GA (median [IQR]: 0 [0-2] vs 2 [0-4],  P  = .002). There were no statistically significant differences in total opioid or nonopioid analgesic, 6- and 24-hour pain scores, median time to first analgesic, or pain interference. No adverse events occurred.
CONCLUSIONS


LA was associated with significant improvement in pain scores in the immediate recovery period. LA did not reduce postprocedural opioid use, nor did it improve QoL for patients undergoing BMAB with GA.",2019,"There were no statistically significant differences in total opioid or nonopioid analgesic, 6- and 24-hour pain scores, median time to first analgesic, or pain interference.","['56 participants randomly assigned (3-16.5 years old', 'Pediatric patients with cancer undergo repeated painful procedures, including bone marrow aspirations and biopsies (BMABs', 'Children with neuroblastoma']","['LA', 'GA versus GA + LA', 'Local Anesthesia With General Anesthesia', 'GA + LA', 'general anesthesia (GA) alone, the other with GA plus local anesthesia (LA) (GA + LA', 'sequential BMABs']","['discomfort, anxiety, and distress', 'adverse events', 'total opioid and nonopioid analgesics, pain scores, time to first analgesic, QoL, and toxicity', 'procedure-related pain and its interference with quality of life (QoL', 'percentage of participants requiring postprocedural opioids', 'Pain scores', 'total opioid or nonopioid analgesic, 6- and 24-hour pain scores, median time to first analgesic, or pain interference', 'pain scores']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0398523', 'cui_str': 'Bone marrow aspiration procedure'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0242937', 'cui_str': 'Non-Opioid Analgesics'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",56.0,0.229846,"There were no statistically significant differences in total opioid or nonopioid analgesic, 6- and 24-hour pain scores, median time to first analgesic, or pain interference.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Zarnegar-Lumley', 'Affiliation': 'Departments of Pediatrics, sara.zarnegar@vumc.org.'}, {'ForeName': 'Katharine R', 'Initials': 'KR', 'LastName': 'Lange', 'Affiliation': 'Departments of Pediatrics.'}, {'ForeName': 'Melissa D', 'Initials': 'MD', 'LastName': 'Mathias', 'Affiliation': 'Departments of Pediatrics.'}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Nakajima-Hatano', 'Affiliation': 'Departments of Pediatrics.'}, {'ForeName': 'Katharine M', 'Initials': 'KM', 'LastName': 'Offer', 'Affiliation': 'Departments of Pediatrics.'}, {'ForeName': 'Ugochi O', 'Initials': 'UO', 'LastName': 'Ogu', 'Affiliation': 'Departments of Pediatrics.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Ortiz', 'Affiliation': 'Departments of Pediatrics.'}, {'ForeName': 'Kay See', 'Initials': 'KS', 'LastName': 'Tan', 'Affiliation': 'Epidemiology and Biostatistics.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kellick', 'Affiliation': 'Pharmacy, and.'}, {'ForeName': 'Shakeel', 'Initials': 'S', 'LastName': 'Modak', 'Affiliation': 'Departments of Pediatrics.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Roberts', 'Affiliation': 'Departments of Pediatrics.'}, {'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'Basu', 'Affiliation': 'Departments of Pediatrics.'}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'Dingeman', 'Affiliation': 'Departments of Pediatrics.'}]",Pediatrics,['10.1542/peds.2018-3829']
2852,30973998,Effects of the P-Glycoprotein Inhibitor Clarithromycin on the Pharmacokinetics of Intravenous and Oral Trospium Chloride: A 4-Way Crossover Drug-Drug Interaction Study in Healthy Subjects.,"The quaternary ammonium compound trospium chloride is poorly absorbed from 2 ""absorption windows"" in the jejunum and cecum/ascending colon, respectively. To confirm whether intestinal P-glycoprotein (P-gp) is involved, a 4-period, crossover drug interaction study with trospium chloride after intravenous (2 mg) and oral administration (30 mg) without and after comedication of clarithromycin (500 mg), an inhibitor for P-gp, was initiated in 12 healthy subjects. Pharmacokinetics of trospium was evaluated using gas chromatography-mass spectrometry, noncompartmental evaluation, and pharmacokinetic modeling. Trospium chloride was poorly absorbed after oral administration (absolute bioavailability, ∼8%-10%). About 30% of the bioavailable dose fraction was absorbed from the ""narrow window"". Comedication with clarithromycin increased steady-state distribution volumes by ∼27% (P < .01). Bioavailability was not increased as hypothesized. The geometric mean ratios (90% confidence interval) for area under the plasma concentration-time curve, maximum concentration, and renal clearance accounted for 0.75 (0.56-1.01), 0.64 (0.45-0.89), and 1.00 (0.90-1.13), respectively. The amount of trospium absorbed from the ""narrow window"" was reduced in all subjects but from the ""wider window"" in only 9 of them. Bioavailability was strongly predicted by the maximum absorption rate of trospium in the distal ""window"" (rs 2   = 0.910, P < .0001). In conclusion, the P-gp inhibitor clarithromycin significantly increases distribution volumes but not oral absorption of trospium. The amount absorbed from the ""narrow window"" was lowered in all subjects. However, the extent of all influences seems not to be of clinical relevance.",2019,Comedication with clarithromycin increased steady-state distribution volumes by ∼27% (P < .01).,"['Healthy Subjects', '12 healthy subjects']","['intestinal P-glycoprotein (P-gp', 'clarithromycin', 'Oral Trospium Chloride', 'P-Glycoprotein Inhibitor Clarithromycin', 'Trospium chloride']","['maximum absorption rate of trospium', 'geometric mean ratios', 'plasma concentration-time curve, maximum concentration, and renal clearance', 'steady-state distribution volumes', 'Bioavailability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0242643', 'cui_str': 'ATP Binding Cassette Transporter, Sub-Family B, Member 1'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0077408', 'cui_str': 'trospium chloride'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0772089', 'cui_str': 'Trospium'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0232813', 'cui_str': 'Renal clearance, function (observable entity)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}]",12.0,0.0224912,Comedication with clarithromycin increased steady-state distribution volumes by ∼27% (P < .01).,"[{'ForeName': 'Bayew Tsega', 'Initials': 'BT', 'LastName': 'Abebe', 'Affiliation': 'Department of Clinical Pharmacology, Center of Drug Absorption and Transport (C_DAT), University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'Department of Pharmacology, Martin Luther University Halle-Wittenberg, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Modess', 'Affiliation': 'Department of Clinical Pharmacology, Center of Drug Absorption and Transport (C_DAT), University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Roustom', 'Affiliation': 'Department of Clinical Pharmacology, Center of Drug Absorption and Transport (C_DAT), University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Tadken', 'Affiliation': 'Department of Clinical Pharmacology, Center of Drug Absorption and Transport (C_DAT), University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Wegner', 'Affiliation': 'Department of Clinical Pharmacology, Center of Drug Absorption and Transport (C_DAT), University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schwantes', 'Affiliation': 'Department Medical Science/Clinical Research, Dr. Pfleger Arzneimittel GmbH, Bamberg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Neumeister', 'Affiliation': 'Department Medical Science/Clinical Research, Dr. Pfleger Arzneimittel GmbH, Bamberg, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Schulz', 'Affiliation': 'LAFAA, Laboratory for Contract Research in Clinical Pharmacology and Biopharmaceutical Analytics GmbH, Bad Schwartau, Germany.'}, {'ForeName': 'Eberhard', 'Initials': 'E', 'LastName': 'Scheuch', 'Affiliation': 'Department of Clinical Pharmacology, Center of Drug Absorption and Transport (C_DAT), University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Siegmund', 'Affiliation': 'Department of Clinical Pharmacology, Center of Drug Absorption and Transport (C_DAT), University of Greifswald, Greifswald, Germany.'}]",Journal of clinical pharmacology,['10.1002/jcph.1421']
2853,29985636,Designing Effective Testimonial Pictorial Warning Labels for Tobacco Products.,"Warning labels on tobacco products sometimes feature images and stories of real people whose health has been affected by smoking. We examined effects of some of the design elements that may contribute to the effectiveness of these testimonial pictorial warning labels (PWLs). Beginning with a testimonial PWL that contained an image of a person and a basic warning statement (e.g., ""Smoking can kill you""), we examined the impact of adding: (a) text detailing the person's name, age and health status (identifiers); and (b) explanatory statements that elaborated on the basic warning using a testimonial or non-testimonial message. In an online experiment, 1255 adult smokers in the United States were randomly assigned to one of six experimental conditions (2 [identifier: none/identifier] × 3 [explanatory statement: none/non-testimonial/testimonial]), or a control condition (text only warning labels that currently appear on packs in the United States). In each condition, participants were exposed to multiple labels each focused on a different health effect. Effectiveness was assessed using emotional responses, engagement and behavioral intentions measured immediately post-exposure, and quit attempts measured at five-week follow up. Testimonial PWLs were more effective than the text only labels. However, there was little evidence that adding identifiers or the explanatory statements enhanced effectiveness; rather, there was some evidence that testimonial explanatory statements reduced effectiveness. These findings suggest that the most effective design for testimonial PWLs may be to combine a basic warning statement with an image of a real person, without any additional textual components.",2019,Testimonial PWLs were more effective than the text only labels.,"['× 3 [explanatory statement: none/non-testimonial/testimonial]), or a control condition (text only warning labels that currently appear on packs in the United States', '1255 adult smokers in the United States']",[],"['emotional responses, engagement and behavioral intentions measured immediately post-exposure, and quit attempts']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]",[],"[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",1255.0,0.0256797,Testimonial PWLs were more effective than the text only labels.,"[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Brennan', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Maloney', 'Affiliation': 'Penn Tobacco Center of Regulatory Science, Annenberg School for Communication, University of Pennsylvania.'}, {'ForeName': 'Yotam', 'Initials': 'Y', 'LastName': 'Ophir', 'Affiliation': 'Penn Tobacco Center of Regulatory Science, Annenberg School for Communication, University of Pennsylvania.'}, {'ForeName': 'Joseph N', 'Initials': 'JN', 'LastName': 'Cappella', 'Affiliation': 'Penn Tobacco Center of Regulatory Science, Annenberg School for Communication, University of Pennsylvania.'}]",Health communication,['10.1080/10410236.2018.1493417']
2854,31948641,Effect of Alirocumab on Lipoprotein(a) and Cardiovascular Risk After Acute Coronary Syndrome.,"BACKGROUND


Lipoprotein(a) concentration is associated with cardiovascular events. Alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, lowers lipoprotein(a) and low-density lipoprotein cholesterol (LDL-C).
OBJECTIVES


A pre-specified analysis of the placebo-controlled ODYSSEY Outcomes trial in patients with recent acute coronary syndrome (ACS) determined whether alirocumab-induced changes in lipoprotein(a) and LDL-C independently predicted major adverse cardiovascular events (MACE).
METHODS


One to 12 months after ACS, 18,924 patients on high-intensity statin therapy were randomized to alirocumab or placebo and followed for 2.8 years (median). Lipoprotein(a) was measured at randomization and 4 and 12 months thereafter. The primary MACE outcome was coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, or hospitalization for unstable angina.
RESULTS


Baseline lipoprotein(a) levels (median: 21.2 mg/dl; interquartile range [IQR]: 6.7 to 59.6 mg/dl) and LDL-C [corrected for cholesterol content in lipoprotein(a)] predicted MACE. Alirocumab reduced lipoprotein(a) by 5.0 mg/dl (IQR: 0 to 13.5 mg/dl), corrected LDL-C by 51.1 mg/dl (IQR: 33.7 to 67.2 mg/dl), and reduced the risk of MACE (hazard ratio [HR]: 0.85; 95% confidence interval [CI]: 0.78 to 0.93). Alirocumab-induced reductions of lipoprotein(a) and corrected LDL-C independently predicted lower risk of MACE, after adjustment for baseline concentrations of both lipoproteins and demographic and clinical characteristics. A 1-mg/dl reduction in lipoprotein(a) with alirocumab was associated with a HR of 0.994 (95% CI: 0.990 to 0.999; p = 0.0081).
CONCLUSIONS


Baseline lipoprotein(a) and corrected LDL-C levels and their reductions by alirocumab predicted the risk of MACE after recent ACS. Lipoprotein(a) lowering by alirocumab is an independent contributor to MACE reduction, which suggests that lipoprotein(a) should be an independent treatment target after ACS. (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab; NCT01663402).",2020,"Alirocumab-induced reductions of lipoprotein(a) and corrected LDL-C independently predicted lower risk of MACE, after adjustment for baseline concentrations of both lipoproteins and demographic and clinical characteristics.","['One to 12\xa0months after ACS, 18,924 patients on high-intensity statin therapy', 'patients with recent acute coronary syndrome (ACS']","['placebo', 'alirocumab', 'Alirocumab', 'alirocumab or placebo']","['Lipoprotein(a) and Cardiovascular Risk', 'coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, or hospitalization for unstable angina', 'corrected LDL-C', 'corrected LDL-C levels', 'lipoprotein(a) and low-density lipoprotein cholesterol (LDL-C', 'risk of MACE', 'Alirocumab reduced lipoprotein(a', 'lipoprotein(a']","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4047691', 'cui_str': 'High-intensity statin therapy (procedure)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}]","[{'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",,0.423186,"Alirocumab-induced reductions of lipoprotein(a) and corrected LDL-C independently predicted lower risk of MACE, after adjustment for baseline concentrations of both lipoproteins and demographic and clinical characteristics.","[{'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, Alabama. Electronic address: vbittner@uab.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'State University of New York, Downstate School of Public Health, Brooklyn, New York.'}, {'ForeName': 'Philip E', 'Initials': 'PE', 'LastName': 'Aylward', 'Affiliation': 'South Australian Health and Medical Research Institute, Flinders University and Medical Centre, Adelaide, South Australia, Australia.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts. Electronic address: https://twitter.com/DLBHATTMD.""}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Cardiológicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina.'}, {'ForeName': 'Jay M', 'Initials': 'JM', 'LastName': 'Edelberg', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Zlatko', 'Initials': 'Z', 'LastName': 'Fras', 'Affiliation': 'Division of Medicine, Department of Vascular Medicine, Preventive Cardiology Unit, University Medical Centre Ljubljana, Ljubljana, Slovenia; Medical Faculty, University of Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada; St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Sigrun', 'Initials': 'S', 'LastName': 'Halvorsen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway; University of Oslo, Oslo, Norway.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Hanotin', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Harrington', 'Affiliation': 'Stanford Center for Clinical Research, Department of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Loizeau', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Moriarty', 'Affiliation': 'Division of Clinical Pharmacology, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Angèle', 'Initials': 'A', 'LastName': 'Moryusef', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Tarrytown, New York.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina; Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sinnaeve', 'Affiliation': 'Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium; University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Tsimikas', 'Affiliation': 'Division of Cardiovascular Medicine, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Vogel', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Services Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Doron', 'Initials': 'D', 'LastName': 'Zahger', 'Affiliation': 'Soroka University Medical Center, Faculty of Health Sciences, Ben Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Zeiher', 'Affiliation': 'Department of Medicine III, Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Ph Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Université de Paris, FACT (French Alliance for Cardiovascular Trials), INSERM U1148, Paris, France; National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, United Kingdom. Electronic address: https://twitter.com/gabrielsteg.'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.10.057']
2855,30636448,Effectiveness of the VAMOS Strategy for Increasing Physical Activity and Healthy Dietary Habits: A Randomized Controlled Community Trial.,"This study aimed to evaluate the effectiveness of the VAMOS strategy (Health-Improving Active Life) in improving physical activity (PA), dietary habits, and anthropometric variables of primary health care (PHC) users in Brazil. A randomized controlled community trial was conducted at two units of the Health Academy Program (HAP; a service provided by PHC), which were randomly assigned either to control group (CG) or intervention group (IG). Participants in both groups (CG = 156 and IG = 135) took part in physical activity classes provided by HAP facilities with those in IG also participating in the VAMOS strategy for 12 weeks. This strategy is based on social cognitive theory. The main behavioral constructs addressed were self-efficacy, goal setting, self-monitoring, identification of social support and barriers, and solutions for the identified barriers. Physical activity was measured with accelerometers, and nutritional status was assessed using dietary habits questionnaires and anthropometric measurements. Intention-to-treat analysis revealed that participants in IG increased the daily time of moderate-vigorous PA and the frequency of raw vegetable intake, while the intake of ultra-processed foods was reduced. Weight loss among participants who were classified as overweight/obese at baseline was observed in the intervention group compared to control. These results suggest that the VAMOS strategy was effective in increasing PA, healthy dietary habits, and decreasing weight among PHC users. Therefore, VAMOS could be used as a strategy to strengthen individuals' autonomy regarding healthy choices and improve their overall health.",2019,"Intention-to-treat analysis revealed that participants in IG increased the daily time of moderate-vigorous PA and the frequency of raw vegetable intake, while the intake of ultra-processed foods was reduced.","['Healthy Dietary Habits', 'two units of the Health Academy Program (HAP; a service provided by PHC', 'primary health care (PHC) users in Brazil']","['VAMOS', 'control group (CG) or intervention group (IG', 'VAMOS strategy (Health-Improving Active Life']","['daily time of moderate-vigorous PA and the frequency of raw vegetable intake', 'dietary habits questionnaires and anthropometric measurements', 'Weight loss', 'physical activity (PA), dietary habits, and anthropometric variables', 'Physical activity', 'self-efficacy, goal setting, self-monitoring, identification of social support and barriers, and solutions']","[{'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1281951', 'cui_str': 'Raw vegetable'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0037438'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]",,0.0515158,"Intention-to-treat analysis revealed that participants in IG increased the daily time of moderate-vigorous PA and the frequency of raw vegetable intake, while the intake of ultra-processed foods was reduced.","[{'ForeName': 'Simone Teresinha', 'Initials': 'ST', 'LastName': 'Meurer', 'Affiliation': '1 Federal University of Santa Catarina, Florianópolis, Brazil.'}, {'ForeName': 'Aline Cristine Souza', 'Initials': 'ACS', 'LastName': 'Lopes', 'Affiliation': '3 Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Fabio Araujo', 'Initials': 'FA', 'LastName': 'Almeida', 'Affiliation': '4 University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Raquel de Deus', 'Initials': 'RD', 'LastName': 'Mendonça', 'Affiliation': '3 Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Tânia Rosane Bertoldo', 'Initials': 'TRB', 'LastName': 'Benedetti', 'Affiliation': '1 Federal University of Santa Catarina, Florianópolis, Brazil.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198118820095']
2856,31985129,"Effects of a 4-week Omaha System transitional care programme on rheumatoid arthritis patients' self-efficacy, health status, and readmission in mainland China: A randomized controlled trial.","BACKGROUND AND AIM


To our knowledge, the practice of transitional care was not common in mainland China. This study was designed to test the intervention effects of a specific dose (4 weeks) of an Omaha-based system transitional care programme for Chinese patients suffering from rheumatoid arthritis.
METHODS


The intervention group adopted a 4-week nurse-led transitional care intervention based on the Omaha System. The control group used a comparable length of routine care. The outcome indexes were a Chinese version of the Arthritis Self-Efficacy Scale-8, Health Assessment Questionnaire-Disability Index, and hospital readmission rates. Data were collected from June 2018 to December 2018.
RESULTS


Finally, 88 patients (44 in the intervention group and 44 in the control group) entered the data analysis. Baseline sociodemographic data for both groups were not found to be statistically significant. The self-efficacy and HAQ-DI of the intervention group were significantly different from the control group. Although the readmission rates of the intervention group were lower than that of the control group, it was not statistically significant.
CONCLUSIONS


This 4-week transitional care intervention dose is sufficient to provide evidence for improving self-efficacy to implement disease management and enhancing physical function of patients diagnosed with rheumatoid arthritis.",2020,"Although the readmission rates of the intervention group were lower than that of the control group, it was not statistically significant.
","['Data were collected from June 2018 to December 2018', 'in mainland China', 'Chinese patients suffering from rheumatoid arthritis', 'patients diagnosed with rheumatoid arthritis', '88 patients (44 in the intervention group and 44 in the control group) entered the data analysis', 'rheumatoid arthritis patients']","['4-week nurse-led transitional care intervention based on the Omaha System', '4-week Omaha System transitional care programme', 'specific dose (4 weeks) of an Omaha-based system transitional care programme']","['self-efficacy, health status, and readmission', 'Chinese version of the Arthritis Self-Efficacy Scale-8, Health Assessment Questionnaire-Disability Index, and hospital readmission rates', 'readmission rates', 'self-efficacy and HAQ-DI']","[{'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C3666006', 'cui_str': 'Arthritis (SMQ)'}, {'cui': 'C0222045'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire (assessment scale)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0102923', 'cui_str': 'HAQ'}]",,0.032869,"Although the readmission rates of the intervention group were lower than that of the control group, it was not statistically significant.
","[{'ForeName': 'Zhi-Chen', 'Initials': 'ZC', 'LastName': 'Liu', 'Affiliation': 'Department of Nursing, General Hospital of Western Command Theater, Chengdu, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': ""School of Nursing, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Wen-Hao', 'Initials': 'WH', 'LastName': 'Zhang', 'Affiliation': ""School of Nursing, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""School of Nursing, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Rong-Rong', 'Initials': 'RR', 'LastName': 'Liu', 'Affiliation': ""School of Nursing, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Bao-Hua', 'Initials': 'BH', 'LastName': 'Cao', 'Affiliation': ""School of Nursing, Air Force Medical University, Xi'an, China.""}]",International journal of nursing practice,['10.1111/ijn.12817']